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UNITED STATES SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 10-Q
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QUARTERLY Report PURSUANT TO Section 13 or 15(d) of the Securities Exchange Act of 1934 |
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For the quarterly period ended September 30, 2024 |
OR
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Transition Report pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 |
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For the transition period from __________ to ____________ |
Commission File Number: 001-33407
PERSPECTIVE THERAPEUTICS, INC.
(Exact name of registrant as specified in its charter)
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Delaware |
41-1458152 |
(State or other jurisdiction of incorporation or organization) |
(I.R.S. Employer Identification No.) |
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2401 Elliott Avenue, Suite 320 Seattle, Washington |
98121 |
(Address of principal executive offices) |
(Zip Code) |
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Registrant’s telephone number, including area code: (206) 676-0900 |
Securities registered pursuant to Section 12(b) of the Act:
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Title of each class |
Trading Symbol(s) |
Name of each exchange on which registered |
Common Stock, $0.001 par value |
CATX |
NYSE American LLC |
Indicate by check mark whether the registrant: (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days. Yes ☒ No ☐
Indicate by check mark whether the registrant has submitted electronically every Interactive Data File required to be submitted pursuant to Rule 405 of Regulation S-T (§232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit such files). Yes ☒ No ☐
Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, a smaller reporting company, or an emerging growth company. See the definitions of “large accelerated filer,” “accelerated filer,” “smaller reporting company,” and “emerging growth company” in Rule 12b-2 of the Exchange Act.
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Large accelerated filer |
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Accelerated filer |
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Non-accelerated filer |
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Smaller reporting company |
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Emerging growth company |
☐ |
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐
Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act). Yes ☐ No ☒
Number of shares outstanding of each of the issuer’s classes of common stock as of the latest practicable date:
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Class |
Outstanding as of November 7, 2024 |
Common stock, $0.001 par value |
67,587,540 |
CAUTIONARY NOTE REGARDING FORWARD-LOOKING STATEMENTS
In addition to historical information, this Quarterly Report on Form 10-Q (Form 10-Q), contains certain “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995 (PSLRA). This statement is included for the express purpose of availing Perspective Therapeutics, Inc. of the protections of the safe harbor provisions of the PSLRA.
This Form 10-Q, including Management’s Discussion and Analysis of Financial Condition and Results of Operations in Part I, Item 2, contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended (the Securities Act), and Section 21E of the Securities Exchange Act of 1934, as amended (the Exchange Act). All statements contained in this Form 10-Q other than statements of historical fact, including, without limitation, statements regarding our future financial condition, results of operations, business strategy and plans and objectives of management for future operations, industry trends and other future events are forward-looking statements. In some cases, you can identify forward-looking statements by terminology, such as “believe,” “expect,” “anticipate,” “intend,” “estimate,” “forecast,” “project,” “may,” “could,” “might,” “plan,” “should,” “will,” “would” or the negative of these terms and other similar expressions, although not all forward-looking statements contain these identifying terms. Forward-looking statements in this Form 10-Q include, among other things:
•the timing, progress and results of our preclinical studies and clinical trials of our current and future program candidates, including statements regarding the timing of our planned regulatory communications, submissions and approvals, initiation and completion of studies or trials and related preparatory work and the period during which the results of the trials will become available, and our research and development programs;
•our ability to obtain and maintain regulatory approvals for our future program candidates;
•our manufacturing capabilities and strategy, including the scalability and commercial viability of our manufacturing methods and processes;
•our ability to identify patients with the diseases treated by our program candidates and to enroll these patients in our clinical trials;
•our expectations regarding the potential functionality, capabilities and benefits of our program candidates, if approved, for commercial use;
•the potential size of the commercial market for our program candidates;
•our expectations regarding the scope of any approved indication for any program candidate;
•our ability to successfully commercialize our program candidates;
•our ability to leverage technology to identify and develop future program candidates;
•our estimates of our expenses, ongoing losses, future revenue, capital requirements and our need for or ability to obtain additional funding before we can expect to generate any revenue from product sales;
•our belief regarding the sufficiency of our cash resources to fund our current planned operating expenses and capital expenditure requirements into mid-2026;
•our competitive position and expectations regarding developments and projections relating to our competitors or our industry; and
•expectations, beliefs, intentions and strategies regarding the future.
These statements are based on certain assumptions and analyses made by us in light of our experience and our assessment of historical trends, current conditions and expected future developments as well as other factors we believe are appropriate under the circumstances. Consequently, all of the forward-looking statements made in this Form 10-Q are qualified by these cautionary statements and there can be no assurance that the actual results anticipated by management will be realized or, even if substantially realized, that they will have the expected consequences to or effects on our business operations. Readers are cautioned not to place undue reliance on such forward-looking statements as they speak only of our views as of the date the statement was made (or any earlier date indicated in such statement). While we may update certain forward-looking statements from time to time, we undertake no obligation to do so, whether as a result of new information, future events or otherwise, except as required by applicable law. Our U.S. Securities and Exchange Commission (SEC) filings are available publicly on the SEC’s website at www.sec.gov.
AVAILABLE INFORMATION
As soon as reasonably practicable after they are filed electronically with the SEC, our annual reports on Form 10-K, quarterly reports on Form 10-Q, current reports on Form 8-K, other SEC filings and amendments to those reports are available without charge on our website, www.perspectivetherapeutics.com, which we also use to announce material information to the public. We are providing the address to our website solely for the information of investors. We do not intend the address to be an active link or to otherwise incorporate the contents of the website into this Form 10-Q.
PERSPECTIVE THERAPEUTICS, INC.
Table of Contents
PART I - FINANCIAL INFORMATION
ITEM 1 - FINANCIAL STATEMENTS
Perspective Therapeutics, Inc. and Subsidiaries
Condensed Consolidated Balance Sheets
(In thousands, except shares and par value data)
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September 30, |
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December 31, |
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2024 |
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2023 |
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(unaudited) |
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ASSETS |
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Current assets: |
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Cash and cash equivalents |
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$ |
226,443 |
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$ |
9,238 |
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Short-term investments |
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41,404 |
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- |
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Accounts receivable, net of allowance for doubtful accounts: 2024 - $592; 2023 - $650 |
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217 |
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1,165 |
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Prepaid expenses and other current assets |
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2,108 |
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1,133 |
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Current assets held for sale, discontinued operations |
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- |
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5,301 |
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Total current assets |
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270,172 |
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16,837 |
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Noncurrent assets: |
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Property and equipment, net |
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43,792 |
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5,576 |
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Right-of-use asset, net |
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2,433 |
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747 |
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Restricted cash |
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- |
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182 |
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Intangible assets, in-process research and development |
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50,000 |
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50,000 |
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Goodwill |
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24,062 |
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24,062 |
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Other assets, net |
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694 |
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487 |
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Total assets |
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$ |
391,153 |
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$ |
97,891 |
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LIABILITIES AND STOCKHOLDERS' EQUITY |
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Current liabilities: |
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Accounts payable and accrued expenses |
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$ |
21,813 |
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$ |
6,909 |
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Lease liability |
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903 |
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46 |
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Accrued personnel expenses |
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3,976 |
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3,588 |
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Note payable |
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51 |
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49 |
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Deferred Income (Note 3) |
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1,400 |
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- |
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Current liabilities of discontinued operations |
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- |
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5,072 |
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Total current liabilities |
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28,143 |
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15,664 |
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Noncurrent liabilities: |
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Lease liability, net of current portion |
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1,676 |
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780 |
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Note payable, net of current portion |
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1,638 |
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1,676 |
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Deferred Income, net of current portion (Note 3) |
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26,600 |
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- |
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Deferred tax liability |
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4,592 |
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4,592 |
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Other noncurrent liabilities |
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33 |
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- |
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Total liabilities |
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62,682 |
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22,712 |
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Commitments and contingencies (Note 10) |
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Stockholders' equity: |
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|
|
Preferred stock, $0.001 par value; 7,000,000 shares authorized; 5,000,000 designated Series B convertible preferred stock; no shares issued and outstanding as of September 30, 2024 and December 31, 2023 |
|
|
- |
|
|
|
- |
|
Common stock, $0.001 par value; 750,000,000 shares authorized; 67,562,781 and 28,180,985 shares issued and outstanding as of September 30, 2024 and December 31, 2023, respectively1 |
|
|
67 |
|
|
|
28 |
|
Additional paid-in capital1 |
|
|
519,954 |
|
|
|
227,591 |
|
Accumulated deficit |
|
|
(191,550 |
) |
|
|
(152,440 |
) |
Total stockholders' equity |
|
|
328,471 |
|
|
|
75,179 |
|
|
|
|
|
|
|
|
Total liabilities and stockholders' equity |
|
$ |
391,153 |
|
|
$ |
97,891 |
|
1. Amounts for prior periods presented have been retroactively adjusted to reflect the 1-for-10 reverse stock split effected on June 14, 2024. See Note 1 for details.
The accompanying notes are an integral part of these condensed consolidated financial statements.
Perspective Therapeutics, Inc. and Subsidiaries
Condensed Consolidated Statements of Operations (unaudited)
(Dollars and shares in thousands, except for per-share amounts)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended September 30, |
|
|
Nine Months Ended September 30, |
|
|
|
2024 |
|
|
2023 |
|
|
2024 |
|
|
2023 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Grant revenue |
|
$ |
369 |
|
|
$ |
276 |
|
|
$ |
1,220 |
|
|
$ |
1,097 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Operating expenses: |
|
|
|
|
|
|
|
|
|
|
|
|
Research and development |
|
|
12,028 |
|
|
|
5,552 |
|
|
|
28,755 |
|
|
|
14,231 |
|
General and administrative |
|
|
6,975 |
|
|
|
4,474 |
|
|
|
18,367 |
|
|
|
16,124 |
|
Change in estimate of asset retirement obligation (Note 4) |
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
(15 |
) |
Loss on disposal of property and equipment |
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
22 |
|
Total operating expenses |
|
|
19,003 |
|
|
|
10,026 |
|
|
|
47,122 |
|
|
|
30,362 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Operating loss |
|
|
(18,634 |
) |
|
|
(9,750 |
) |
|
|
(45,902 |
) |
|
|
(29,265 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
Non-operating income (expense): |
|
|
|
|
|
|
|
|
|
|
|
|
Interest income |
|
|
3,581 |
|
|
|
204 |
|
|
|
7,868 |
|
|
|
872 |
|
Interest and other expense |
|
|
(69 |
) |
|
|
(14 |
) |
|
|
(121 |
) |
|
|
(58 |
) |
Equity in loss of affiliate |
|
|
- |
|
|
|
(12 |
) |
|
|
(6 |
) |
|
|
(12 |
) |
Total non-operating income (expense), net |
|
|
3,512 |
|
|
|
178 |
|
|
|
7,741 |
|
|
|
802 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss from continuing operations |
|
|
(15,122 |
) |
|
|
(9,572 |
) |
|
|
(38,161 |
) |
|
|
(28,463 |
) |
Net loss from discontinued operations |
|
|
- |
|
|
|
(784 |
) |
|
|
(890 |
) |
|
|
(3,870 |
) |
Loss recognized on classification as held for sale |
|
|
- |
|
|
|
- |
|
|
|
(59 |
) |
|
|
- |
|
Net loss before deferred income tax benefit |
|
|
(15,122 |
) |
|
|
(10,356 |
) |
|
|
(39,110 |
) |
|
|
(32,333 |
) |
Deferred income tax benefit |
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
10,500 |
|
Net loss |
|
$ |
(15,122 |
) |
|
$ |
(10,356 |
) |
|
$ |
(39,110 |
) |
|
$ |
(21,833 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic and diluted loss per share: |
|
|
|
|
|
|
|
|
|
|
|
|
Loss from continuing operations1 |
|
$ |
(0.21 |
) |
|
$ |
(0.34 |
) |
|
$ |
(0.61 |
) |
|
$ |
(0.68 |
) |
Loss from discontinued operations1 |
|
|
- |
|
|
|
(0.03 |
) |
|
|
(0.01 |
) |
|
|
(0.15 |
) |
Basic and diluted loss per share1 |
|
$ |
(0.21 |
) |
|
$ |
(0.37 |
) |
|
$ |
(0.62 |
) |
|
$ |
(0.83 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted average shares used in computing net loss per share: |
|
|
|
|
|
|
|
|
|
|
|
|
Basic and diluted1 |
|
|
70,629 |
|
|
|
28,055 |
|
|
|
62,293 |
|
|
|
26,323 |
|
1. Amounts for prior periods presented have been retroactively adjusted to reflect the 1-for-10 reverse stock split effected on June 14, 2024. See Note 1 for details.
The accompanying notes are an integral part of these condensed consolidated financial statements.
Perspective Therapeutics, Inc. and Subsidiaries
Condensed Consolidated Statements of Cash Flows (unaudited)
(In thousands)
|
|
|
|
|
|
|
|
|
|
|
Nine Months Ended September 30, |
|
|
|
2024 |
|
|
2023 |
|
CASH FLOWS FROM OPERATING ACTIVITIES: |
|
|
|
|
|
|
Net loss |
|
$ |
(39,110 |
) |
|
$ |
(21,833 |
) |
Adjustments to reconcile net loss to net cash provided by (used in) operating activities: |
|
|
|
|
|
|
Foreign currency adjustments |
|
|
39 |
|
|
|
- |
|
Lease expense |
|
|
100 |
|
|
|
35 |
|
Depreciation expense |
|
|
1,585 |
|
|
|
684 |
|
Write-off of inventory associated with discontinued product |
|
|
- |
|
|
|
298 |
|
Loss on disposal of property and equipment |
|
|
- |
|
|
|
22 |
|
Amortization of other assets |
|
|
12 |
|
|
|
30 |
|
Accretion of asset retirement obligation |
|
|
- |
|
|
|
26 |
|
Equity in loss of affiliate |
|
|
6 |
|
|
|
12 |
|
Accrued interest on short-term investments |
|
|
(899 |
) |
|
|
- |
|
Change in allowance for doubtful accounts |
|
|
(58 |
) |
|
|
- |
|
Change in estimate of asset retirement obligation |
|
|
- |
|
|
|
(15 |
) |
Loss on divestiture |
|
|
59 |
|
|
|
- |
|
Share-based compensation |
|
|
3,327 |
|
|
|
3,018 |
|
Deferred income tax benefit |
|
|
- |
|
|
|
(10,500 |
) |
Changes in operating assets and liabilities: |
|
|
|
|
|
|
Accounts receivable |
|
|
890 |
|
|
|
(368 |
) |
Inventory related to discontinued operations (Note 4) |
|
|
11 |
|
|
|
257 |
|
Prepaid expenses and other current assets |
|
|
(975 |
) |
|
|
12 |
|
Accounts payable and accrued expenses |
|
|
14,937 |
|
|
|
(683 |
) |
Deferred Income1 |
|
|
28,000 |
|
|
|
- |
|
Accrued personnel expenses |
|
|
388 |
|
|
|
1,100 |
|
Net cash provided by (used in) operating activities |
|
|
8,312 |
|
|
|
(27,905 |
) |
|
|
|
|
|
|
|
CASH FLOWS FROM INVESTING ACTIVITIES: |
|
|
|
|
|
|
Additions to property and equipment |
|
|
(39,800 |
) |
|
|
(983 |
) |
Additions to other assets |
|
|
(24 |
) |
|
|
(18 |
) |
Proceeds from maturity of short-term investments |
|
|
38,225 |
|
|
|
22,764 |
|
Purchases of short-term investments |
|
|
(78,730 |
) |
|
|
- |
|
Net cash acquired in acquisition of Viewpoint |
|
|
- |
|
|
|
2,699 |
|
Net cash (used in) provided by investing activities |
|
|
(80,329 |
) |
|
|
24,462 |
|
|
|
|
|
|
|
|
CASH FLOWS FROM FINANCING ACTIVITIES: |
|
|
|
|
|
|
Repayment of notes payable |
|
|
(36 |
) |
|
|
(56 |
) |
Proceeds from sales of common stock, pursuant to exercise of warrants, net |
|
|
125 |
|
|
|
- |
|
Proceeds from sales of common stock, pursuant to exercise of options |
|
|
896 |
|
|
|
554 |
|
Proceeds from the issuance of common stock and Pre-funded Warrants, net1 |
|
|
288,055 |
|
|
|
- |
|
Issuance costs related to common stock issued in exchange for Viewpoint common stock |
|
|
- |
|
|
|
(65 |
) |
Net cash provided by financing activities |
|
|
289,040 |
|
|
|
433 |
|
|
|
|
|
|
|
|
Net increase (decrease) in cash, cash equivalents and restricted cash |
|
|
217,023 |
|
|
|
(3,010 |
) |
Cash, cash equivalents and restricted cash beginning of period |
|
|
9,420 |
|
|
|
21,175 |
|
CASH, CASH EQUIVALENTS AND RESTRICTED CASH END OF PERIOD |
|
$ |
226,443 |
|
|
$ |
18,165 |
|
|
|
|
|
|
|
|
Reconciliation of cash, cash equivalents and restricted cash to the condensed consolidated balance sheets: |
|
|
|
|
|
|
Cash and cash equivalents |
|
$ |
226,443 |
|
|
$ |
17,983 |
|
Restricted cash |
|
|
- |
|
|
|
182 |
|
Total cash, cash equivalents and restricted cash shown on the condensed consolidated statements of cash flows |
|
$ |
226,443 |
|
|
$ |
18,165 |
|
|
|
|
|
|
|
|
Supplemental schedule of noncash investing and financing activities: |
|
|
|
|
|
|
Recognition of operating lease liability and right-of-use asset |
|
$ |
2,115 |
|
|
$ |
811 |
|
Additions to property and equipment |
|
|
16,518 |
|
|
|
- |
|
Fair value of Viewpoint assets acquired including goodwill |
|
|
- |
|
|
|
85,885 |
|
13,654,5072 shares of Perspective Therapeutics common stock issued in exchange for Viewpoint common stock |
|
|
- |
|
|
|
(54,618 |
) |
Assumption of Viewpoint stock options and warrants at fair value |
|
|
- |
|
|
|
(7,836 |
) |
Note receivable and accrued interest from Viewpoint forgiven |
|
|
- |
|
|
|
(6,171 |
) |
1. See Note 3, Investments and Agreements, for additional information.
2. Amount for prior period presented has been retroactively adjusted to reflect the 1-for-10 reverse stock split effected on June 14, 2024. See Note 1 for details.
The accompanying notes are an integral part of these condensed consolidated financial statements.
Perspective Therapeutics, Inc. and Subsidiaries
Condensed Consolidated Statements of Changes in Stockholders’ Equity (unaudited)
(In thousands, except shares)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Common Stock |
|
|
|
|
|
|
|
|
|
|
|
|
Shares1 |
|
|
Amount1 |
|
|
Additional Paid-in Capital1 |
|
|
Accumulated Deficit |
|
|
Total |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balances at December 31, 2022 |
|
|
14,211,276 |
|
|
$ |
14 |
|
|
$ |
160,560 |
|
|
$ |
(105,932 |
) |
|
$ |
54,642 |
|
Issuance of common stock in exchange for Viewpoint common stock, net |
|
|
13,654,507 |
|
|
14 |
|
|
|
54,539 |
|
|
|
- |
|
|
|
54,553 |
|
Assumption of Viewpoint stock options and warrants at fair value |
|
|
- |
|
|
|
- |
|
|
|
7,836 |
|
|
|
- |
|
|
|
7,836 |
|
Share-based compensation |
|
|
- |
|
|
|
- |
|
|
|
1,368 |
|
|
|
- |
|
|
|
1,368 |
|
Net loss |
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
(371 |
) |
|
|
(371 |
) |
Balances at March 31, 2023 |
|
|
27,865,783 |
|
|
$ |
28 |
|
|
$ |
224,303 |
|
|
$ |
(106,303 |
) |
|
$ |
118,028 |
|
Issuance of common stock pursuant to exercise of options |
|
|
182,158 |
|
|
|
- |
|
|
|
532 |
|
|
|
- |
|
|
|
532 |
|
Share-based compensation |
|
|
- |
|
|
|
- |
|
|
|
1,199 |
|
|
|
- |
|
|
|
1,199 |
|
Net loss |
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
(11,106 |
) |
|
|
(11,106 |
) |
Balances at June 30, 2023 |
|
|
28,047,941 |
|
|
$ |
28 |
|
|
$ |
226,034 |
|
|
$ |
(117,409 |
) |
|
$ |
108,653 |
|
Issuance of common stock pursuant to exercise of options |
|
|
9,160 |
|
|
|
- |
|
|
|
22 |
|
|
|
- |
|
|
|
22 |
|
Share-based compensation |
|
|
- |
|
|
|
- |
|
|
|
451 |
|
|
|
- |
|
|
|
451 |
|
Net loss |
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
(10,356 |
) |
|
|
(10,356 |
) |
Balances at September 30, 2023 |
|
|
28,057,101 |
|
|
$ |
28 |
|
|
$ |
226,507 |
|
|
$ |
(127,765 |
) |
|
$ |
98,770 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Common Stock |
|
|
|
|
|
|
|
|
|
|
|
|
Shares1 |
|
|
Amount1 |
|
|
Additional Paid-in Capital1 |
|
|
Accumulated Deficit |
|
|
Total |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balances at December 31, 2023 |
|
|
28,180,985 |
|
|
$ |
28 |
|
|
$ |
227,591 |
|
|
$ |
(152,440 |
) |
|
$ |
75,179 |
|
Issuance of common stock pursuant to the Public Offering, net2 |
|
|
15,639,954 |
|
|
|
16 |
|
|
|
53,125 |
|
|
|
- |
|
|
|
53,141 |
|
Issuance of Jan. 2024 Pre-funded Warrants, net2 |
|
|
- |
|
|
|
- |
|
|
|
10,208 |
|
|
|
- |
|
|
|
10,208 |
|
Issuance of common stock pursuant to the Lantheus Investment Agreement, net2 |
|
|
5,634,235 |
|
|
|
6 |
|
|
|
20,840 |
|
|
|
- |
|
|
|
20,846 |
|
Issuance of common stock pursuant to the March 2024 Investment Agreement, net2 |
|
|
9,200,998 |
|
|
|
9 |
|
|
|
82,010 |
|
|
|
- |
|
|
|
82,019 |
|
Issuance of common stock pursuant to exercise of options |
|
|
35,424 |
|
|
|
- |
|
|
|
126 |
|
|
|
- |
|
|
|
126 |
|
Share-based compensation |
|
|
- |
|
|
|
- |
|
|
|
656 |
|
|
|
- |
|
|
|
656 |
|
Net loss |
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
(12,284 |
) |
|
|
(12,284 |
) |
Balances at March 31, 2024 |
|
|
58,691,596 |
|
|
$ |
59 |
|
|
$ |
394,556 |
|
|
$ |
(164,724 |
) |
|
$ |
229,891 |
|
Issuance of common stock pursuant to exercise of options |
|
|
24,450 |
|
|
|
- |
|
|
|
128 |
|
|
|
- |
|
|
|
128 |
|
Issuance of stock pursuant to exercise of common stock warrants |
|
|
22,401 |
|
|
|
- |
|
|
|
123 |
|
|
|
- |
|
|
|
123 |
|
Issuance of common stock pursuant to the ATM, net2 |
|
|
3,535,246 |
|
|
|
3 |
|
|
|
47,930 |
|
|
|
- |
|
|
|
47,933 |
|
Issuance of common stock pursuant to the Registered Offering, net2 |
|
|
5,151,588 |
|
|
|
5 |
|
|
|
71,863 |
|
|
|
- |
|
|
|
71,868 |
|
Issuance of May 2024 Pre-funded Warrants, net2 |
|
|
- |
|
|
|
- |
|
|
|
2,040 |
|
|
|
- |
|
|
|
2,040 |
|
Share-based compensation |
|
|
- |
|
|
|
- |
|
|
|
719 |
|
|
|
- |
|
|
|
719 |
|
Cancellation of fractional shares due to the 1-for-10 reverse stock split |
|
|
(114 |
) |
|
|
- |
|
|
|
(1 |
) |
|
|
- |
|
|
|
(1 |
) |
Net loss |
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
(11,704 |
) |
|
|
(11,704 |
) |
Balances at June 30, 2024 |
|
|
67,425,167 |
|
|
$ |
67 |
|
|
$ |
517,358 |
|
|
$ |
(176,428 |
) |
|
$ |
340,997 |
|
Issuance of common stock pursuant to exercise of options |
|
|
137,229 |
|
|
|
- |
|
|
|
642 |
|
|
|
- |
|
|
|
642 |
|
Issuance of stock pursuant to exercise of common stock warrants |
|
|
385 |
|
|
|
- |
|
|
|
2 |
|
|
|
- |
|
|
|
2 |
|
Share-based compensation |
|
|
- |
|
|
|
- |
|
|
|
1,952 |
|
|
|
- |
|
|
|
1,952 |
|
Net loss |
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
(15,122 |
) |
|
|
(15,122 |
) |
Balances at September 30, 2024 |
|
|
67,562,781 |
|
|
$ |
67 |
|
|
$ |
519,954 |
|
|
$ |
(191,550 |
) |
|
$ |
328,471 |
|
1. Amounts for prior periods presented have been retroactively adjusted to reflect the 1-for-10 reverse stock split effected on June 14, 2024. See Note 1 for details.
2. See Note 3, Investments and Agreements, for additional information.
The accompanying notes are an integral part of these condensed consolidated financial statements.
Perspective Therapeutics, Inc.
Notes to the Unaudited Condensed Consolidated Financial Statements
1.Basis of Presentation and Summary of Significant Accounting Policies
Perspective Therapeutics, Inc. is developing the next generation of precision-targeted alpha therapies (TAT) for oncology that have the potential to treat a large population of cancer patients across multiple tumor types, including those with metastatic disease. The accompanying unaudited condensed consolidated financial statements are those of Perspective Therapeutics, Inc., and its wholly owned subsidiaries, referred to herein as “Perspective Therapeutics” or the “Company.” All significant intercompany accounts and transactions have been eliminated in consolidation. In the opinion of management, all adjustments necessary for the fair presentation of the condensed consolidated financial statements have been included. These unaudited condensed consolidated financial statements should be read in conjunction with the Company’s audited consolidated financial statements and related notes as set forth in the Company’s Annual Report on Form 10-K for the period ended December 31, 2023 filed with the SEC on March 28, 2024 (2023 Form 10-K).
The unaudited condensed consolidated financial statements have been prepared in accordance with generally accepted accounting principles in the United States (U.S. GAAP). Certain information and note disclosures normally included in financial statements prepared in accordance with U.S. GAAP have been condensed or omitted pursuant to those rules and regulations, although the Company believes that the disclosures are adequate for the information not to be misleading. The unaudited condensed consolidated financial statements reflect, in management’s opinion, all adjustments of a normal, recurring nature that are necessary for the fair statement of the Company’s financial position, results of operations and cash flows for the interim periods, but are not necessarily indicative of the results expected for the full fiscal year or any other period.
The Company anticipates that as the result of continuing operating losses and the significant net operating losses available from prior fiscal years, its effective income tax rate for fiscal year 2024 will be 0%.
Merger
On February 3, 2023, the Company completed the merger of Isoray Acquisition Corp., a Delaware corporation and wholly owned subsidiary of the Company, with Viewpoint Molecular Targeting, Inc. (Viewpoint) (such transaction being the Merger). Pursuant to the Merger, the Company issued 13,654,507 shares of its common stock, par value $0.001 per share (Common Stock), representing approximately 49% of its fully diluted outstanding capital stock as of the close of the Merger. Viewpoint is an alpha-particle radiopharmaceutical company in the alpha-emitter market developing oncology therapeutics and complementary imaging agents. For additional information, see Note 14, Merger, in this Form 10-Q.
Discontinued Operations
On April 12, 2024, the Company completed the sale of its Cesium-131 brachytherapy business and substantially all of the assets of Isoray Medical, Inc. (Isoray), a wholly owned subsidiary of Perspective Therapeutics, to GT Medical Technologies, Inc., a Delaware corporation (GT Medical) (such transaction being the GT Medical Closing). Pursuant to the GT Medical Closing, GT Medical issued to Isoray 279,516 shares of GT Medical’s common stock, par value $0.0001 per share, representing 0.5% of GT Medical’s issued and outstanding capital stock on a fully diluted basis as of the closing. Accordingly, the financial information and operating results of the Cesium-131 brachytherapy business have been presented as discontinued operations in the condensed consolidated financial statements for all periods presented. Unless otherwise noted, discussion within these notes to the condensed consolidated financial statements relates to continuing operations. For additional information, see Note 4, Discontinued Operations, in this Form 10-Q.
Reverse Stock Split
On June 14, 2024, the Company effected a 1-for-10 reverse stock split (Reverse Split) of the Company’s issued and outstanding shares of Common Stock, and the Common Stock began trading on a split-adjusted basis on June 17, 2024. The Reverse Split did not reduce the total number of authorized shares of Common Stock or the Company’s preferred stock (Preferred Stock), or change the par values of the Common Stock or Preferred Stock. The Reverse Split affected all stockholders uniformly and did not affect any stockholder’s ownership percentage of the shares of Common Stock (except to the extent that the Reverse Split resulted in some of the stockholders receiving cash in lieu of fractional shares). All outstanding options and warrants entitling their holders to purchase shares of Common Stock were adjusted as a result of the Reverse Split, in accordance with the terms of each such security. In addition, the number of shares reserved for future issuance pursuant to the Company’s equity incentive plans was also adjusted accordingly. As a result, all historical per share data, number of shares issued and outstanding, and outstanding options and warrants for the periods presented in the accompanying condensed consolidated financial statements and notes thereto have been adjusted retroactively in this Form 10-Q, where applicable, to reflect the Reverse Split.
Liquidity
The Company assesses its liquidity in terms of its ability to generate cash to fund its operating, investing and financing activities. The Company has had a history of operating losses and an absence of significant recurring cash inflows from revenue. At September 30,
2024, the Company had cash, cash equivalents and short-term investments of $267.8 million and total accumulated deficit of $191.6 million. The Company has historically financed its operations primarily through selling equity.
The Company believes that its $267.8 million of cash, cash equivalents and short-term investments as of September 30, 2024 will enable it to fund its current planned operations into mid-2026, though it may raise additional capital through a combination of equity offerings, debt financings, collaborations, strategic alliances and marketing, distribution or licensing arrangements and/or government funding and grants.
The accompanying unaudited condensed consolidated financial statements have been prepared on a going concern basis, which contemplates the realization of assets and satisfaction of liabilities in the ordinary course of business. The operating plan may change as a result of many factors currently unknown to management, and there can be no assurance that the current operating plan will be achieved in the timeframe anticipated by management or at all, and the Company may need to seek additional funds sooner than anticipated. The unaudited condensed consolidated financial statements do not include any adjustments relating to the recoverability and classification of recorded asset amounts or the amounts and classification of liabilities that might result from potential unknown factors.
Reclassifications
In addition to the discontinued operations discussed above, during the first quarter of 2024, the Company made certain reclassifications to prior period amounts in the condensed consolidated financial statements and accompanying notes to conform to the current period presentation. The reclassification of these items had no impact on net loss, financial position or cash flows in the current or prior periods. Specifically, accrued payroll and related taxes and accrued vacation were combined to create accrued personnel, and accrued protocol expense and accrued waste disposal were included in accounts payable and accrued expenses, all of which are presented on the condensed consolidated balance sheets and condensed consolidated statement of cash flows.
Significant Accounting Policies
The Company’s significant accounting policies and recent accounting pronouncements are described in Note 2, Summary of Significant Accounting Policies, to the consolidated financial statements in Item 8 of the 2023 Form 10-K. There have been no changes to the Company’s significant accounting policies, and the Company has not adopted any significant accounting policies during the nine months ended September 30, 2024.
Basic and diluted loss per share is calculated by dividing net loss by the weighted average number of shares of Common Stock outstanding and does not include the impact of any potentially dilutive common stock equivalents. In January 2024 and May 2024, the Company issued pre-funded warrants in connection with the Public Offering (as defined below) and the Registered Offering (as defined below), respectively (see Note 3, Investments and Agreements, in this Form 10-Q). As the pre-funded warrants’ exercise price is nominal and there are no conditions that must be satisfied prior to their exercise, the pre-funded warrants are included in the calculation of the basic and diluted earnings per share as of September 30, 2024. At each of September 30, 2024 and 2023, the calculation of diluted weighted average shares did not include common stock warrants or options that were potentially convertible into Common Stock as those would be antidilutive due to the Company’s net loss position.
Securities not considered in the calculation of diluted loss per share, but that could be dilutive in the future, are as follows (in thousands):
|
|
|
|
|
|
|
|
|
|
|
September 30, 2024 |
|
|
September 30, 2023 |
|
Common stock warrants |
|
|
416 |
|
|
|
576 |
|
Common stock options |
|
|
7,252 |
|
|
|
4,468 |
|
Total potential dilutive securities |
|
|
7,668 |
|
|
|
5,044 |
|
Effective upon the closing of the Merger with Viewpoint on February 3, 2023, the Company assumed 338,709 warrants to purchase shares of Common Stock with an exercise price of $2.70 per share and 2,426,342 options to purchase shares of Common Stock with exercise prices ranging from $1.30 to $3.00 per share.
3.Investments and Agreements
2024 At-the-Market (ATM) Agreement
On August 13, 2024, the Company entered into a Controlled Equity OfferingSM Sales Agreement (2024 ATM Agreement) with Cantor Fitzgerald & Co. and RBC Capital Markets, LLC (each, an ATM Agent, and together, the ATM Agents) pursuant to which the Company
from time to time may offer and sell shares (2024 ATM Shares) of its Common Stock, through or to the ATM Agents having an aggregate sales price of up to $250.0 million.
Subject to the terms and conditions of the 2024 ATM Agreement, each ATM Agent is required to use its commercially reasonable efforts to sell the ATM Shares from time to time, based upon the Company’s instructions. The Company has provided the ATM Agents with customary indemnification rights, and the ATM Agents will be entitled to a commission of up to 3.0% of the gross proceeds from each sale of the ATM Shares effectuated through or to the applicable ATM Agent selling the ATM Shares.
Sales of the 2024 ATM Shares, if any, under the 2024 ATM Agreement may be made in transactions that are deemed to be “at the market offerings” as defined in Rule 415 under the Securities Act of 1933, as amended. The Company has no obligation to sell any of the 2024 ATM Shares and may at any time suspend offers under the 2024 ATM Agreement or terminate the 2024 ATM Agreement.
The Common Stock to be sold under the 2024 ATM Agreement, if any, will be issued and sold pursuant to the Company’s automatic shelf registration statement on Form S-3 (File No. 333-279692) (the May 2024 Registration Statement), which became effective upon filing with the SEC on May 24, 2024. On August 13, 2024, the Company filed a prospectus supplement to the May 2024 Registration Statement with the SEC in connection with the offer and sale of the 2024 ATM Shares pursuant to the 2024 ATM Agreement.
As of September 30, 2024, the Company has not completed any transactions pursuant to the 2024 ATM Agreement.
May 2024 Registered Offering
On May 24, 2024, the Company entered into an underwriting agreement with BofA Securities, Inc., as representative of the underwriters named therein, in connection with its previously announced underwritten offering (Registered Offering) of 5,151,588 shares (Registered Offering Shares) of Common Stock and, in lieu of Registered Offering Shares to certain investors, pre-funded warrants (May 2024 Pre-funded Warrants) to purchase 146,425 shares of Common Stock. The price to the investors for the Registered Offering Shares was $15.10 per Registered Offering Share, and the price to the investors for the May 2024 Pre-funded Warrants was $15.09 per May 2024 Pre-funded Warrant, which represents the per share price for the Registered Offering Shares less the $0.01 per share exercise price for each such May 2024 Pre-funded Warrant. The Registered Offering closed on May 29, 2024. BofA Securities, Inc., Oppenheimer & Co. Inc. and RBC Capital Markets, LLC acted as joint book-running managers for the Registered Offering and B. Riley Securities, Inc. acted as a co-manager for the Registered Offering. JonesTrading Institutional Services LLC acted as a financial advisor for the Registered Offering.
The gross proceeds to the Company from the Registered Offering were approximately $80.0 million, before underwriting discounts and commissions and estimated expenses of the Registered Offering.
The Registered Offering was made pursuant to the May 2024 Registration Statement, a related base prospectus, free writing prospectus and prospectus supplement each dated May 24, 2024.
The May 2024 Pre-funded Warrants became exercisable subsequent to the filing and effectiveness of an amendment to the Company’s Amended and Restated Certificate of Incorporation with the Secretary of State of the State of Delaware on June 14, 2024. The exercise price and the number of shares of Common Stock issuable upon exercise of each May 2024 Pre-funded Warrant are subject to appropriate adjustment in the event of certain stock dividends and distributions, stock splits, stock combinations, reclassifications or similar events affecting the Common Stock as well as upon any distribution of assets, including cash, stock or other property, to the Company’s stockholders. The May 2024 Pre-funded Warrants will not expire and are exercisable in cash or by means of a cashless exercise. A holder of May 2024 Pre-funded Warrants may not exercise such May 2024 Pre-funded Warrants if the aggregate number of shares of Common Stock beneficially owned by such holder, together with its affiliates, would be more than 4.99% or 9.99%, as elected by such holder, of the issued and outstanding shares of Common Stock following such exercise, as such percentage ownership is determined in accordance with the terms of the May 2024 Pre-funded Warrants. A holder of May 2024 Pre-funded Warrants may increase or decrease this percentage not in excess of 19.99% by providing at least 61 days’ prior notice to the Company.
March 2024 Private Placement with Institutional Investors
On March 4, 2024, the Company entered into an investment agreement (the March 2024 Investment Agreement) with certain accredited institutional investors (Institutional Investors) pursuant to which the Company agreed to issue and sell, in a private placement (the March 2024 Private Placement), 9,200,998 shares of Common Stock, for a purchase price of $9.50 per share, representing the closing price of the Common Stock on March 1, 2024. The closing of the March 2024 Private Placement occurred on March 6, 2024.
The gross proceeds to the Company from the March 2024 Private Placement were approximately $87.4 million, before deducting fees payable to the Placement Agents (as defined below) and other estimated transaction expenses.
The March 2024 Private Placement was conducted pursuant to a Placement Agency Agreement, dated March 4, 2024 (the Placement Agency Agreement), by and between the Company and Oppenheimer & Co. Inc., as representative of the placement agents named therein (the Placement Agents). Per the Placement Agency Agreement, the Company agreed to: (i) pay the Placement Agents a cash fee
equal to 5.85% of the gross proceeds received by the Company from the sale of the shares; and (ii) reimburse the Placement Agents for certain fees and expenses.
Lantheus Agreements
Investment Agreement
On January 8, 2024, the Company entered into an investment agreement (the Lantheus Investment Agreement) with Lantheus Alpha Therapy, LLC, a Delaware limited liability company and wholly owned subsidiary of Lantheus Holdings, Inc. (Lantheus), pursuant to which the Company agreed to sell and issue to Lantheus in a private placement transaction certain shares (the Lantheus Shares) of Common Stock. The closing of the purchase and sale of the Lantheus Shares to Lantheus by the Company (the Lantheus Closing) was subject to the Company raising at least $50.0 million of gross proceeds (excluding Lantheus’ investment) in a qualifying third-party financing transaction, which occurred on January 22, 2024.
The number of Lantheus Shares sold was 5,634,235, representing 19.99% of the outstanding shares of Common Stock as of January 8, 2024. Pursuant to the Lantheus Investment Agreement, the Company agreed to cooperate in good faith to negotiate and enter into a registration rights agreement with Lantheus, obligating the Company to file a registration statement on Form S-3 with the SEC to register for resale the Lantheus Shares issued at the Lantheus Closing. The Company filed such Form S-3 on March 29, 2024, and the SEC declared it effective on April 9, 2024 (File No. 333-278362).
The Lantheus Investment Agreement also contains agreements of the Company and Lantheus whereby Lantheus is provided certain board observer and information rights of the Company, as well as standstill provisions prohibiting Lantheus from taking certain actions for a specified period of time, subject to certain exceptions.
The Lantheus Investment Agreement also provides Lantheus with certain pro rata participation rights to maintain its ownership position in the Company in the event that the Company makes any public or non-public offering of any equity or voting interests in the Company or any securities that are convertible or exchangeable into (or exercisable for) equity or voting interests in the Company, subject to certain exceptions.
Pursuant to the Lantheus Investment Agreement, the Company is required to notify Lantheus within 10 business days of the end of a fiscal quarter in which the Company issued shares of Common Stock pursuant to that certain At Market Issuance Sales Agreement among the Company, Oppenheimer & Co. Inc., B. Riley Securities, Inc., and JonesTrading Institutional Services LLC dated November 17, 2023 (the ATM Agreement), of (i) the number of shares of Common Stock issued during such fiscal quarter pursuant to the ATM Agreement and (ii) the average price per share received by the Company before commissions (the ATM Average Price). Upon receipt of such notice, Lantheus may elect, at its option, to purchase all or a portion of its Pro Rata Portion (as defined in the Lantheus Investment Agreement) of such shares at an aggregate price equal to the number of shares purchased multiplied by the ATM Average Price for such quarter (the ATM Participation Right). Pursuant to the Lantheus Investment Agreement, Lantheus may not exercise the ATM Participation Right more than two times per calendar year.
Asset Purchase Agreement
On January 8, 2024, the Company entered into an Asset Purchase Agreement (the Progenics APA) with Progenics Pharmaceuticals, Inc., a Delaware corporation (Progenics) and affiliate of Lantheus, pursuant to which the Company acquired certain assets and the associated lease of Progenics’ radiopharmaceutical manufacturing facility in Somerset, New Jersey for a purchase price of $8.0 million in cash. The transactions contemplated by the Progenics APA closed on March 1, 2024.
Option Agreement
On January 8, 2024, the Company entered into an option agreement (the Option Agreement) with Lantheus whereby Lantheus was granted an exclusive option to negotiate an exclusive, worldwide, royalty- and milestone-bearing right and license to [212Pb]VMT-α-NET, the Company’s clinical-stage alpha therapy developed for the treatment of neuroendocrine tumors. If good-faith negotiations fail, Lantheus has a one-year right to reenter negotiations if a third party offers to purchase or license the [212Pb]VMT-α-NET program. Additionally, Lantheus has a right to co-fund the Investigational New Drug (IND) application, enabling studies for early-stage therapeutic candidates targeting prostate-specific membrane antigen and gastrin-releasing peptide receptor and, prior to IND filing, a right to negotiate for an exclusive license to such candidates. In consideration of the rights granted by the Company to Lantheus pursuant to the Option Agreement, Lantheus paid to the Company a one-time payment of $28.0 million, subject to certain withholding provisions associated with the closing of the Progenics APA.
Under the terms of the Option Agreement, Lantheus also has a right of first offer and last look protections for any third-party merger and acquisition transactions involving the Company for a 12-month period beginning on January 8, 2024.
The Company determined that the Option Agreement should be accounted for as a research and development arrangement in accordance with Accounting Standards Codification (ASC) 730-20, Research and Development Arrangements, as Lantheus held approximately
19.9% of the Company’s outstanding Common Stock at March 31, 2024. The Option Agreement contains no repayment provisions, does not create any obligation to enter into any license, transfer or sale agreements with Lantheus, and does not restrict the use of the funds in any way.
Accordingly, the balance sheet reports current and long-term liabilities related to these options under the caption, “Deferred Income.” The values for each distinct option within the Option Agreement were determined by estimating the fair value of each distinct option by a third-party valuation firm and the liabilities will be recognized as income in the condensed consolidated statement of operations as the various options expire.
January 2024 Public Offering
On January 17, 2024, the Company entered into an underwriting agreement (Underwriting Agreement) with Oppenheimer & Co. Inc., as representative of the underwriters named therein (the Underwriters), in connection with its previously announced underwritten public offering (Public Offering) of 13,207,521 shares (Public Shares) of Common Stock and, in lieu of Public Shares to certain investors, pre-funded warrants (Jan. 2024 Pre-funded Warrants) to purchase 3,008,694 shares of Common Stock. The price to the public for the Public Shares was $3.70 per Public Share, and the price to the public for the Jan. 2024 Pre-funded Warrants was $3.69 per Jan. 2024 Pre-funded Warrant, which represents the per share price for the Public Shares less the $0.01 per share exercise price for each such Jan. 2024 Pre-funded Warrant. Under the terms of the Underwriting Agreement, the Company granted the Underwriters an option, exercisable for 30 days, to purchase up to an additional 2,432,432 shares of Common Stock at the same price per share as the Public Shares, which was fully exercised by the Underwriters on January 18, 2024. The Public Offering closed on January 22, 2024.
The gross proceeds to the Company from the Public Offering were approximately $69.0 million, before underwriting discounts and commissions and estimated expenses of the Public Offering.
The Public Offering was made pursuant to the Company’s shelf registration statement on Form S-3 (File No. 333-275638), declared effective by the SEC on December 14, 2023, a base prospectus dated December 14, 2023, and the related prospectus supplement dated January 17, 2024.
The Jan. 2024 Pre-funded Warrants are exercisable at any time after the date of issuance. The exercise price and the number of shares of Common Stock issuable upon exercise of each Jan. 2024 Pre-funded Warrant are subject to appropriate adjustment in the event of certain stock dividends and distributions, stock splits, stock combinations, reclassifications or similar events affecting the Common Stock as well as upon any distribution of assets, including cash, stock or other property, to the Company’s stockholders. The Jan. 2024 Pre-funded Warrants will not expire and are exercisable in cash or by means of a cashless exercise. A holder of Jan. 2024 Pre-funded Warrants may not exercise such Jan. 2024 Pre-funded Warrants if the aggregate number of shares of Common Stock beneficially owned by such holder, together with its affiliates, would beneficially own more than 4.99% of the issued and outstanding shares of Common Stock following such exercise, as such percentage ownership is determined in accordance with the terms of the Jan. 2024 Pre-funded Warrants. A holder of Jan. 2024 Pre-funded Warrants may increase or decrease this percentage not in excess of 19.99% by providing at least 61 days’ prior notice to the Company.
2023 ATM Agreement
The Company entered into an ATM Issuance Sales Agreement, dated November 17, 2023, by and among the Company, Oppenheimer & Co., Inc., B. Riley Securities, Inc. and JonesTrading Institutional Services LLC (2023 ATM Agreement). Pursuant to the 2023 ATM Agreement, the Company established an ATM equity program under which it may offer and sell shares of its Common Stock, from time to time.
On November 17, 2023, the Company filed a shelf registration statement on Form S-3 with the SEC (File No. 333-275638) and accompanying base prospectus, declared effective by the SEC on December 14, 2023, for the offer and sale of up to $200.0 million of its securities (December 2023 Registration Statement). Also on November 17, 2023, the Company filed a prospectus supplement with the SEC in connection with the offering of up to $50.0 million of shares of its Common Stock pursuant to the 2023 ATM Agreement under the December 2023 Registration Statement. In December 2023, the Company sold 123,882 shares under the 2023 ATM Agreement at an average price of approximately $3.03 per common share for gross proceeds of approximately $0.4 million.
On April 11, 2024, the Company sold 3,535,246 shares of its Common Stock under the 2023 ATM Agreement at an average price of approximately $14.00 per common share, resulting in gross proceeds of approximately $49.5 million.
On May 25, 2024, the Company terminated the offering of securities pursuant to the December 2023 Registration Statement in connection with the filing and effectiveness of the May 2024 Registration Statement.
On August 7, 2024, the Company delivered written notice to Oppenheimer & Co., Inc., B. Riley Securities, Inc. and JonesTrading Institutional Services LLC that it was terminating the 2023 ATM Sales Agreement, which termination became effective August 12, 2024.
For additional information related to certain of the agreements discussed above, see Note 20, Subsequent Events, in the Company’s 2023 Form 10-K.
4.Discontinued Operations
The GT Medical Closing occurred on April 12, 2024 (GT Medical Closing Date). Previously, the Company announced that on December 7, 2023, Isoray entered into an Asset Purchase Agreement (GT Medical APA) by and among Isoray, the Company, and GT Medical pursuant to which Isoray would sell to GT Medical, and GT Medical would purchase from Isoray, all of Isoray’s right, title and interest in and to substantially all of the assets of Isoray related to Isoray’s commercial Cesium-131 business (the Business) including equipment, certain contracts, inventory and intellectual property. Subject to limited exceptions set forth in the GT Medical APA, GT Medical did not assume the liabilities of Isoray.
Pursuant to the terms of, and subject to the conditions specified in, the GT Medical APA, at the GT Medical Closing, (i) GT Medical issued to Isoray 279,516 shares of GT Medical’s common stock, par value $0.0001 per share, representing 0.5% of GT Medical’s issued and outstanding capital stock on a fully diluted basis as of the GT Medical Closing Date and (ii) Isoray has the right to receive, and GT Medical is obligated to pay, certain cash royalty payments during each of the first four years beginning upon the GT Medical Closing Date (each such year, a Measurement Period), as summarized below:
•with respect to GT Medical’s net sales of Cesium-131 brachytherapy seeds for cases that do not utilize GT Medical’s GammaTile Therapy: (a) if such net sales for a Measurement Period are $10.0 million or less, 3.0% of such net sales; (b) if such net sales for a Measurement Period are greater than $10.0 million and less than $15.0 million, 4.0% of such net sales; and (c) if such net sales for a Measurement Period are $15.0 million or more, 5.0% of such net sales; and
•with respect to GT Medical’s net sales of GT Medical’s GammaTile Therapy utilizing Cesium-131 brachytherapy seeds: 0.5% of such net sales for a Measurement Period.
In accordance with ASC 205-20, Presentation of Financial Statements – Discontinued Operations, the following table presents the major classes of assets and liabilities of discontinued operations of the Business reported in the condensed consolidated balance sheets and prior year amounts have been reclassified.
|
|
|
|
|
|
|
|
|
|
|
September 30, 2024 |
|
|
December 31, 2023 |
|
(in thousands) |
|
|
|
|
|
|
Assets held for sale of discontinued operations, current |
|
|
|
|
|
|
Inventory |
|
$ |
- |
|
|
$ |
3,148 |
|
Prepaid expenses and other current assets |
|
|
- |
|
|
|
169 |
|
Property and equipment, net |
|
|
- |
|
|
|
1,263 |
|
Right-of-use asset, net |
|
|
- |
|
|
|
676 |
|
Other assets, net |
|
|
- |
|
|
|
45 |
|
Total current assets held for sale of discontinued operations |
|
$ |
- |
|
|
$ |
5,301 |
|
|
|
|
|
|
|
|
Liabilities held for sale of discontinued operations, current |
|
|
|
|
|
|
Lease liability |
|
$ |
- |
|
|
$ |
677 |
|
Asset retirement obligation |
|
|
- |
|
|
|
225 |
|
Loss recognized on classification as held for sale |
|
|
- |
|
|
|
4,170 |
|
Total current liabilities of discontinued operations |
|
$ |
- |
|
|
$ |
5,072 |
|
The following table presents the components of discontinued operations in relation to the Business reported in the unaudited condensed consolidated statements of operations (in thousands):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended September 30, |
|
|
Nine Months Ended September 30, |
|
|
|
2024 |
|
|
2023 |
|
|
2024 |
|
|
2023 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Sales, net |
|
$ |
- |
|
|
$ |
1,909 |
|
|
$ |
2,178 |
|
|
$ |
5,239 |
|
Cost of sales |
|
|
- |
|
|
|
1,447 |
|
|
|
1,564 |
|
|
|
4,863 |
|
Gross profit |
|
|
- |
|
|
|
462 |
|
|
|
614 |
|
|
|
376 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Operating expenses: |
|
|
|
|
|
|
|
|
|
|
|
|
Research and development |
|
|
- |
|
|
|
169 |
|
|
|
69 |
|
|
|
1,000 |
|
Sales and marketing |
|
|
- |
|
|
|
855 |
|
|
|
941 |
|
|
|
2,578 |
|
General and administrative |
|
|
- |
|
|
|
222 |
|
|
|
494 |
|
|
|
668 |
|
Total operating expenses |
|
|
- |
|
|
|
1,246 |
|
|
|
1,504 |
|
|
|
4,246 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total loss from discontinued operations |
|
$ |
- |
|
|
$ |
(784 |
) |
|
$ |
(890 |
) |
|
$ |
(3,870 |
) |
The Company determined the loss recognized on classification as held for sale by identifying the assets and liabilities that are included in the GT Medical APA and are included in the table above. Additionally, the loss recognized on classification as held for sale was determined using the estimated fair value of the GT Medical stock of $0.2 million received less the carrying value of the net assets sold. The fair value of the stock received was determined based on information provided to the Company by GT Medical from a current valuation study that was prepared for them. Excluded from the calculation of the loss are contingent royalties that could be received from future sales.
Certain amounts included in the unaudited condensed consolidated statements of cash flows related to the discontinued operations are as follows (in thousands):
|
|
|
|
|
|
|
|
|
|
|
Nine Months Ended September 30, |
|
|
|
2024 |
|
|
2023 |
|
|
|
|
|
|
|
|
Depreciation |
|
$ |
- |
|
|
$ |
171 |
|
Amortization |
|
|
- |
|
|
|
27 |
|
Write-off of inventory associated with discontinued product |
|
|
- |
|
|
|
298 |
|
Share-based compensation |
|
|
166 |
|
|
|
568 |
|
Additions to property and equipment |
|
|
- |
|
|
|
287 |
|
The Company previously had a restricted cash account to provide collateral for the decommissioning of its leased facility for Cesium-131 production. This facility lease was assumed by GT Medical as part of the GT Medical APA which included the commitment to decommission the facility. The Company has subsequently moved the full balance of the restricted cash account to its general operating cash accounts.
For the three and nine months ended September 30, 2024 and 2023, there was no provision (benefit) for income taxes recorded related to the discontinued operations. Additionally, the Company is in a loss position and has recorded a full valuation allowance for the deferred tax assets associated with the discontinued operations.
On July 15, 2024, August 2, 2024 and October 31, 2024, the Company purchased a building located in the Houston, Texas, metropolitan area for $4.7 million, a building in the Chicago, Illinois, metropolitan area for $5.0 million, and a building in the Los Angeles, California, metropolitan area for $11.0 million, respectively, which it intends to use for the manufacture of its program candidates upon completion of modifications and installation of equipment.
On September 18, 2024, the Company entered into a Master Equipment and Services Agreement (MESA) and statements of work (SOWs) thereunder with Comecer SpA (Comecer), pursuant to which the Company agreed to purchase from Comecer manufacturing equipment for the production of the Company’s radiopharmaceutical products including, but not limited to, isotope processing hot cells and production suites and related equipment (collectively, the Deliverables) and services for installation and validation of the Deliverables at several of the Company’s production facilities in the United States. The aggregate consideration for such equipment and services pursuant to the MESA and SOWs is approximately €49.0 million payable in cash, excluding certain incidental costs such as taxes, customs and duties, local transport, insurance and rigging. The Company may also elect to purchase certain additional equipment
and services pursuant to the SOWs. The MESA provides for the payment of certain amounts in installments over the course of the production, installation and validation of the Deliverables.
The Company’s property and equipment consisted of the following as of:
|
|
|
|
|
|
|
|
|
|
|
September 30, 2024 |
|
|
December 31, 2023 |
|
|
|
(in thousands) |
|
Building |
|
$ |
1,770 |
|
|
$ |
1,770 |
|
Land |
|
|
1,283 |
|
|
|
1,283 |
|
Equipment |
|
|
10,601 |
|
|
|
2,683 |
|
Leasehold improvements |
|
|
3,497 |
|
|
|
179 |
|
Other1 |
|
|
28,895 |
|
|
|
330 |
|
Property and equipment |
|
|
46,046 |
|
|
|
6,245 |
|
Less accumulated depreciation |
|
|
(2,254 |
) |
|
|
(669 |
) |
Property and equipment, net |
|
$ |
43,792 |
|
|
$ |
5,576 |
|
1.Property and equipment not placed in service are items that meet the capitalization threshold, or which management believes will meet the threshold at the time of completion and which have yet to be placed into service as of the date of the balance sheets and, therefore, no depreciation expense has been recognized.
6.Goodwill and Other Intangible Assets
Goodwill
The carrying amount of goodwill as of both September 30, 2024 and December 31, 2023 was $24.1 million and has been recorded in connection with the Company’s Merger of Viewpoint in February 2023. The Company tests goodwill and indefinite-lived intangible assets for impairment during the fourth quarter of each year, or more frequently should circumstances change or events occur that would more likely than not reduce the fair value of its assets. No testing was deemed necessary during the three and nine months ended September 30, 2024.
The following table summarizes the components of the Company’s other intangible assets (in thousands):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
September 30, 2024 |
|
|
|
Cost |
|
|
Accumulated Amortization |
|
|
Net Carrying Value |
|
Indefinite-lived intangible assets |
|
|
|
|
|
|
|
|
|
In-process research and development |
|
$ |
50,000 |
|
|
$ |
- |
|
|
$ |
50,000 |
|
Total |
|
$ |
50,000 |
|
|
$ |
- |
|
|
$ |
50,000 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
December 31, 2023 |
|
|
|
Cost |
|
|
Accumulated Amortization |
|
|
Net Carrying Value |
|
Indefinite-lived intangible assets |
|
|
|
|
|
|
|
|
|
In-process research and development |
|
$ |
50,000 |
|
|
$ |
- |
|
|
$ |
50,000 |
|
Total |
|
$ |
50,000 |
|
|
$ |
- |
|
|
$ |
50,000 |
|
The Company’s IPR&D assets represent the estimated fair value of Viewpoint’s pipeline of radiotherapy product candidates acquired in February 2023. The estimated fair value of the IPR&D assets at the acquisition date was determined using a probability-weighted income approach, which discounts expected future cash flows to present value. The projected cash flow estimates for Viewpoint’s pipeline of radiotherapy program candidates were based on certain key assumptions, including estimates of future revenue and expenses, taking into account the stage of development of the technology at the Merger date and the time and resources needed to complete development.
7.Held-to-Maturity Investments
The following table summarizes the carrying values and fair values of the Company’s financial instruments (in thousands):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
September 30, 2024 |
|
|
|
Amortized Cost |
|
|
Gross Unrealized Gains |
|
|
Gross Unrealized Losses |
|
|
Estimated Fair Value |
|
U.S. Treasury Bills |
|
$ |
41,404 |
|
|
$ |
11 |
|
|
$ |
- |
|
|
$ |
41,415 |
|
The Company has investments in U.S. Treasury Bills, some of which mature over a period greater than 90 days and are classified as short-term investments. The U.S. Treasury Bills are carried at amortized cost and classified as held-to-maturity as the Company has the intent and the ability to hold them until they mature. The carrying value of the U.S. Treasury Bills are adjusted for accretion of discounts over the remaining life of the investment. Income related to the U.S. Treasury Bills is recognized in interest income in the Company’s condensed consolidated statement of operations. As of December 31, 2023, the Company had no held-to-maturity investments, and no held-to-maturity investments were presented in cash and cash equivalents on its condensed consolidated balance sheet.
8.Fair Value Measurements
Fair value is defined as an exit price, representing the amount that would be received to sell an asset or paid to transfer a liability in an orderly transaction between market participants. As such, fair value is a market-based measurement that should be determined based on assumptions that market participants would use in pricing an asset or liability. As a basis for considering such assumptions, the accounting guidance establishes a three-tier fair value hierarchy, which prioritizes the inputs used in measuring fair value as follows:
Level 1 - Observable inputs such as quoted prices in active markets;
Level 2 - Inputs other than Level 1 prices, such as quoted prices for similar assets or liabilities, quoted prices in markets with insufficient volume or infrequent transactions (less active markets), or model-driven valuations in which all significant inputs are observable or can be derived principally from, or corroborated with, observable market data; and
Level 3 - Unobservable inputs in which little or no market data exists, therefore requiring an entity to develop its own assumptions.
Included in the Company’s cash and cash equivalents in the condensed consolidated balance sheet is its money market fund, which is measured at fair value on a recurring basis and categorized using the fair value hierarchy (in thousands):
|
|
|
|
|
|
|
September 30, 2024 |
|
|
|
Estimated Fair Value Level 1 |
|
Money market fund |
|
$ |
224,502 |
|
There were no Level 2 or Level 3 financial instruments measured at fair value on a recurring basis at September 30, 2024, and the Company did not have any financial instruments measured at fair value on a recurring basis at December 31, 2023.
For information related to short-term investments, see Note 7, Held-to-Maturity Investments.
9.Share-Based Compensation
On May 31, 2024, the Company held its 2024 Annual Meeting of Stockholders (Annual Meeting). At the Annual Meeting, the Company’s stockholders approved the Company’s Third Amended and Restated 2020 Equity Incentive Plan (the Amended and Restated Plan) which, among other things, (a) increased the aggregate number of shares of Common Stock authorized for issuance under the Amended and Restated Plan by 4,870,092 for a total of 12,500,000 shares of Common Stock, and (b) adjusted the “evergreen” provision included therein, such that the number of shares of Common Stock available for the grant of awards under the Amended and Restated Plan will automatically increase on January 1 of each year in an amount equal to 5% of the number of shares of Common Stock issued and outstanding on December 31 of the immediately preceding year (subject to adjustment in the event of stock splits and other similar events); provided, however, that the Company’s Board of Directors may act prior to January 1 of a given year to provide that there will be no increase in the share limit for such year or provide that the increase for such year will be a lesser number of shares of Common Stock. On August 14, 2024, the Company filed a Form S-8 to register 4,870,092 additional shares of Common Stock authorized for issuance under the Amended and Restated Plan as approved by stockholders at the Annual Meeting.
The following table presents the share-based compensation expense recognized for all share-based compensation arrangements, excluding share-based compensation expense reported in Note 4, Discontinued Operations (in thousands):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended September 30, |
|
|
Nine Months Ended September 30, |
|
|
2024 |
|
|
2023 |
|
|
2024 |
|
|
2023 |
|
|
|
|
|
|
|
|
|
|
|
|
|
Research and development |
$ |
814 |
|
|
$ |
179 |
|
|
$ |
1,336 |
|
|
$ |
763 |
|
General and administrative |
|
1,138 |
|
|
|
239 |
|
|
|
1,825 |
|
|
|
1,687 |
|
Total share-based compensation |
$ |
1,952 |
|
|
$ |
418 |
|
|
$ |
3,161 |
|
|
$ |
2,450 |
|
10.Commitments and Contingencies
The Company has been in settlement negotiations with a representative for six stockholder plaintiff firms alleging the Company violated Delaware law in its preliminary proxy statement that was disseminated to stockholders in November 2022 for the Company’s annual meeting held in December 2022. Based on these settlement negotiations to date, the Company estimates that it will settle for no more than an aggregate of $0.2 million and, therefore, recorded an estimated liability of $0.2 million as of December 31, 2023. There was no change in the estimate as of September 30, 2024. This balance is included in accrued expenses on the unaudited condensed consolidated balance sheets.
In connection with the Lantheus Investment Agreement entered into with Lantheus on January 8, 2024, the Company agreed to sell and issue the Lantheus Shares. The number of Lantheus Shares sold was 5,634,235, representing 19.99% of the outstanding shares of Common Stock as of January 8, 2024.
On January 8, 2024, the Company entered into the Progenics APA with Progenics, an affiliate of Lantheus, for a purchase price of $8.0 million. On March 1, 2024, the Company closed on the transactions contemplated by the Progenics APA.
On March 4, 2024, the Company entered into the March 2024 Investment Agreement in which the Company agreed to issue and sell 9,200,998 shares of Common Stock. Lantheus, a significant stockholder of the Company, purchased part of the shares issued to increase their ownership percentage to approximately 19.9% in the Company following the closing of the March 2024 Investment Agreement on March 6, 2024.
For additional information regarding the Lantheus Investment Agreement, the Progenics APA and the March 2024 Investment Agreement, see Note 3, Investments and Agreements.
On August 8, 2024, the Company entered into an access and license agreement with Lantheus. For additional information, see Note 12, Leases.
The Company accounts for its leases under ASC 842, Leases. Effective April 1, 2024, the Company entered into a lease with the Board of Regents, State of Iowa, for lab and office space at the BioVentures Center. The lease terminates in March 2026. Upon entering into this lease, the Company recognized a right-of-use asset and lease liability of approximately $1.1 million on the balance sheet based upon the present value of the future base payments discounted at an 8% discount rate using the rate of interest that the Company would have to pay to borrow on a collateralized basis over a similar term an amount equal to the lease payments in a similar economic environment as the lease does not provide an implicit discount rate.
The Company acquired a lease from Progenics, an affiliate of Lantheus, for a production facility in Somerset, New Jersey effective on March 1, 2024 (see Note 3, Investments and Agreements, in this Form 10-Q). The lease terminates on November 29, 2028. Upon entering into this lease, the Company recognized a right-of-use asset and lease liability of approximately $0.3 million on the balance sheet based upon the present value of the future base payments discounted at an 8% discount rate using the rate of interest that the Company would have to pay to borrow on a collateralized basis over a similar term an amount equal to the lease payments in a similar economic environment as the lease does not provide an implicit discount rate.
On August 8, 2024, the Company assumed a lease from Progenics for office space in Somerset, New Jersey (Office). The lease terminates on November 30, 2028. Upon entering into this lease, the Company recognized a right-of-use asset and lease liability of approximately $0.6 million on the balance sheet based upon the present value of the future base payments discounted at an 8% discount rate using the rate of interest that the Company would have to pay to borrow on a collateralized basis over a similar term an amount equal to the lease payments in a similar economic environment as the lease does not provide an implicit discount rate.
Upon assuming the lease, the Company entered into a license and access agreement with Lantheus, which provides access to both dedicated and shared space of the Office (Access Agreement). There is no renewal option, and the termination options are available only for material breaches. In consideration of the Access Agreement, Lantheus agreed to pay base rent and associated costs through December 2024 directly to the landlord. The base rent through December 2024 is less than $0.1 million (Prepaid Rent). Pursuant to ASC 842, Leases, the Access Agreement is a sublease in which the Company is a sublessor and Lantheus is a sublessee. The Company will amortize the Prepaid Rent over the entire lease term of 52 months.
On July 1, 2023, the Company entered into a lease with Unico Properties LLC for office space in Seattle, Washington that terminates in October 2028. Upon entering into this lease, the Company recognized a right-of-use asset and lease liability of approximately $0.8 million on the balance sheet based upon the present value of the future base payments discounted at an 8% discount rate using the rate
of interest that the Company would have to pay to borrow on a collateralized basis over a similar term an amount equal to the lease payments in a similar economic environment as the lease does not provide an implicit discount rate.
The weighted average remaining term and discount rate for the Company’s operating leases as of September 30, 2024 was 3.2 years and 8%, respectively.
The Company’s operating lease expense was $0.3 million and $0.5 million for the three and nine months ended September 30, 2024, respectively, and $0.2 million and $0.4 million for the three and nine months ended September 30, 2023.
The following table presents the future operating lease payments and lease liability included on the condensed consolidated balance sheet related to the Company’s operating leases as of September 30, 2024 (in thousands):
|
|
|
|
|
Year Ending December 31, |
|
|
|
2024 (remaining three months) |
|
$ |
245 |
|
2025 |
|
|
1,112 |
|
2026 |
|
|
647 |
|
2027 |
|
|
493 |
|
2028 |
|
|
443 |
|
Total |
|
|
2,940 |
|
Less: imputed interest |
|
|
(361 |
) |
Total lease liability |
|
|
2,579 |
|
Less: current portion |
|
|
(903 |
) |
Noncurrent lease liability |
|
$ |
1,676 |
|
Asset Retirement Obligation
The Company had an asset retirement obligation (ARO) associated with the facility it leased in Richland, Washington. This lease is included in the GT Medical APA and was assigned to GT Medical upon the GT Medical Closing, which occurred on April 12, 2024. As such, this liability is no longer reported as an ARO in the Company’s condensed consolidated financial statements as of September 30, 2024 and December 31, 2023. However, the Company maintains the estimated liability in its condensed consolidated financial statements related to hazardous waste removal. The estimated liability at each of September 30, 2024 and December 31, 2023 was $0.5 million and is included within the accounts payable and accrued expenses in the condensed consolidated balance sheets.
The Company assumed two notes payable effective upon the closing of the Merger with Viewpoint on February 3, 2023. On July 19, 2019, Viewpoint entered into a promissory note agreement with the Iowa Economic Development Authority (IEDA) for $0.1 million at 3% interest rate to be paid over 36 monthly payments beginning on the first day of the first month following Viewpoint closing on a $1.0 million equity fundraising round. Final payment was paid in September 2023. The loan was granted as a form of financial assistance to Viewpoint from IEDA.
On December 29, 2022, Viewpoint obtained a promissory note in the amount of $1.7 million for the purpose of purchasing land and a building in Coralville, Iowa. The note bears interest at 6.15% per annum and is collateralized by the property. The note requires monthly principal and interest payments, and a balloon payment of approximately $1.5 million is due on December 29, 2027.
The following table presents the current and long-term portions of the note payable (in thousands):
|
|
|
|
|
|
|
|
|
|
|
September 30, |
|
|
December 31, |
|
|
|
2024 |
|
|
2023 |
|
|
|
|
|
|
|
|
Note payable |
|
$ |
1,689 |
|
|
$ |
1,725 |
|
Less: current portion |
|
|
(51 |
) |
|
|
(49 |
) |
Note payable, long-term portion |
|
$ |
1,638 |
|
|
$ |
1,676 |
|
The following table presents the future principal payments included on the condensed consolidated balance sheet related to the Company’s note payable as of September 30, 2024 (in thousands):
|
|
|
|
|
Years ending December 31: |
|
|
|
2024 (remaining three months) |
|
$ |
13 |
|
2025 |
|
|
52 |
|
2026 |
|
|
55 |
|
2027 |
|
|
1,569 |
|
Total |
|
$ |
1,689 |
|
On February 3, 2023, the Company acquired 100% of the issued and outstanding equity and voting shares of Viewpoint Molecular Targeting, Inc. in exchange for 13,654,507 shares of Common Stock with a fair value of $54.6 million based on the closing market price of $4.00 per share on the acquisition date. At the closing of the Merger, the Company forgave the note receivable entered into in November 2022 and the associated accrued interest with Viewpoint that was included in the note receivable. The total amount forgiven was $6.2 million, representing the $6.0 million loan and $0.2 million accrued interest. The Company also assumed all of Viewpoint’s outstanding stock options and warrants as of the Merger date. The Merger was completed to provide the Company with a new isotope in a larger market.
The Company accounted for the transaction as a business combination in accordance ASC 805, Business Combinations. The Company has performed an allocation of the purchase price paid for the assets acquired and the liabilities assumed with the assistance of an independent valuation firm. The Viewpoint purchase price consideration and allocation to net assets acquired is presented below (in thousands except for share price):
|
|
|
|
|
Fair value of consideration transferred |
|
|
|
Perspective Therapeutics common stock issued (13,654,507 x $4.00) |
|
$ |
54,618 |
|
Assumption of Viewpoint stock options and warrants at fair value |
|
|
7,836 |
|
Note receivable and interest from Viewpoint forgiven |
|
|
6,171 |
|
Total fair value of consideration transferred |
|
$ |
68,625 |
|
|
|
|
|
|
Recognized amounts of identifiable net assets acquired |
|
|
|
Assets acquired |
|
|
|
Cash and cash equivalents |
|
$ |
2,699 |
|
Grants receivable |
|
|
95 |
|
Prepaid expenses |
|
|
396 |
|
Property and equipment |
|
|
5,050 |
|
Right-of-use asset |
|
|
10 |
|
Intangible assets, in-process research and development |
|
|
50,000 |
|
Other assets |
|
|
316 |
|
Total assets acquired |
|
|
58,566 |
|
|
|
|
|
Liabilities assumed |
|
|
|
Accounts payable and accrued expenses |
|
|
2,968 |
|
Lease liability |
|
|
10 |
|
Accrued payroll and related taxes |
|
|
1,642 |
|
Accrued vacation |
|
|
333 |
|
Notes payable |
|
|
1,807 |
|
Deferred tax liability |
|
|
7,243 |
|
Total liabilities assumed |
|
|
14,003 |
|
|
|
|
|
Net assets acquired, excluding goodwill |
|
|
44,563 |
|
Total purchase price consideration |
|
|
68,625 |
|
|
|
|
|
Goodwill |
|
$ |
24,062 |
|
Goodwill is calculated as the difference between the acquisition date fair value of the consideration and the values assigned to the assets acquired and liabilities assumed. Goodwill is not amortized and is not currently assumed to be deductible for tax purposes. The goodwill is attributable to the workforce of the acquired business and the synergies expected to arise from the acquisition of Viewpoint.
Upon completion of the Merger, Viewpoint became a wholly owned subsidiary of the Company and its results of operations have been included in the Company’s condensed consolidated financial statements.
Since the closing date, Viewpoint’s results of operations have been reported in the Company’s condensed consolidated financial statements and include grant revenue of approximately $0.4 million and $0.3 million, respectively, and operating loss of $18.6 million and $9.8 million, respectively, for the three months ended September 30, 2024 and 2023, and grant revenue of approximately $1.2 million and $1.1 million, respectively, and operating loss of $45.9 million and $29.3 million, respectively, for the nine months ended September 30, 2024 and 2023.
ITEM 2 – MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS
You should read the following discussion and analysis of our financial condition and results of operations together (i) with the unaudited condensed consolidated financial statements and the notes thereto included elsewhere in this Quarterly Report on Form 10-Q for the quarter ended September 30, 2024 (Form 10-Q), (ii) with our audited consolidated financial statements and notes thereto contained in our Annual Report on Form 10-K for the year ended December 31, 2023 filed with the Securities and Exchange Commission (SEC) on March 28, 2024 (2023 Form 10-K) and (iii) with other filings we have made with the SEC. As discussed under the heading “Cautionary Note Regarding Forward-Looking Statements,” this discussion contains forward-looking statements that reflect our plans, estimates and beliefs, and involves numerous risks and uncertainties, including but not limited to those described under the heading “Risk Factors” in our 2023 Form 10-K that may cause actual results to differ materially from those described in or implied by any forward-looking statements. Unless the context otherwise requires, references in these notes to “the Company,” “Perspective,” “we,” “us” and “our” except where the context requires otherwise, refer to Perspective Therapeutics, Inc. and its subsidiaries. References to “Viewpoint” refer to Viewpoint Molecular Targeting, Inc., a wholly owned subsidiary, and references to “Isoray” refer to Isoray Medical, Inc., a wholly owned subsidiary.
Overview
We are developing the next generation of precision-targeted alpha therapies (TAT) for oncology that have the potential to treat a large population of cancer patients across multiple tumor types, including those with metastatic disease. By leveraging our proprietary TAT platform, we aim to develop alpha-emitting radiopharmaceuticals that can be attached to targeting peptides to deliver the radioactive payload directly to difficult-to-treat tumors. The foundation of our TAT platform is our Pb-specific chelator (PSC) and peptide linker technology, which is designed to enable us to connect our alpha-emitting isotope of choice, Lead-212 (212Pb or Pb-212), to a desired targeting peptide to deliver radiation directly to cancer cells. Unlike commercially available chelators and linkers, our proprietary PSC and peptide linker have shown, in preclinical studies, the differentiated ability to promote enhanced clearance of the non-tumor localized 212Pb payload without sacrificing the uptake of the alpha particle into the tumor. Rapid clearance of the alpha-emitting isotope from normal tissues is important to enhance tolerability and widen the therapeutic window of our program candidates. We are also developing complementary diagnostics that utilize the same targeting peptide and imaging isotopes such as Lead-203 (203Pb or Pb-203), Gallium-68 (68Ga or Ga-68) or Copper-64 (64Cu or Cu-64) to provide the opportunity to understand which patients may respond to targeted therapy.
Our platform generates TATs that are comprised of three components: (i) a targeting peptide that is designed to selectively target ligands that are unique to, or preferentially expressed on, cancer cells throughout the body; (ii) the alpha-emitting medical isotope 212Pb designed to kill cancer cells; and (iii) our proprietary linker that attaches the targeting molecule to the radioactive payload.
We utilized our TAT platform to discover, design and develop our initial programs, VMT-α-NET and VMT01, which are currently in ongoing Phase 1/2a clinical trials, and we plan to continue to leverage our platform to assess the potential of and develop multiple additional pipeline programs. Using our proprietary platform technology, VMT-α-NET and VMT01 are engineered to target cancer-specific receptors on tumor cells.
VMT-α-NET
[212Pb]VMT-α-NET is a TAT in development for patients with unresectable or metastatic somatostatin receptor type 2 (SSTR2)-expressing tumors who have not previously received peptide-targeted radiopharmaceutical therapy, such as Lutathera. We have initiated dosing in Cohorts 1 and 2 of our Phase 1/2a study of [212Pb]VMT-α-NET in patients with unresectable or metastatic SSTR2-expressing neuroendocrine tumors (NETs). In April 2024, we announced that this program was selected by the U.S. Food and Drug Administration (FDA) to participate in the Chemistry, Manufacturing, and Controls (CMC) Development and Readiness Pilot (CDRP) Program. The FDA’s CDRP Program was initiated in 2022 to facilitate alignment of CMC development of novel products under investigational new drug (IND) applications with expedited clinical development timeframes based upon the anticipated clinical benefits of earlier patient access. The observation period was completed for dose limiting toxicity (DLT) in seven patients enrolled in Cohort 2 during the second quarter of 2024. Subsequently, the safety monitoring committee (SMC) determined that the safety data observations during the DLT period supported proceeding with dose escalation to Cohort 3. A protocol amendment to expand the number of patients dosed at 5 mCi (up to 40 patients) has been submitted to sites and patient enrollment is open. During the third quarter, data informing the SMC’s recommendations were submitted to and accepted for presentation at the 2024 North American Tumor Society (NANETS) Multidisciplinary NET Medical Symposium taking place November 21-23, 2024 in Chicago. We plan to host a conference call at the start of the conference and will provide details prior to the call. Based on FDA interactions prior to the initiation of patient dosing in this study, the decision to open a Cohort 3 will follow after consultation and alignment with the agency.
On June 10, 2024, we announced multiple updates featuring our alpha-particle radiopharmaceuticals at the Society of Nuclear Medicine and Molecular Imaging (SNMMI) 2024 Annual Meeting. The data presentations highlighted favorable safety profiles and potential benefits of our lead clinical candidates. Specifically, we reported on a Phase 0 imaging trial that is evaluating the optimal imaging timepoint(s) for diagnostic/dosimetric performance of [203Pb]VMT-α-NET in neuroendocrine tumors. Investigators analyzed 48 lesions across nine patients, and the results showed that tumor uptake of [203Pb]VMT-α-NET peaked at approximately four hours post-injection,
with 98% of maximum uptake observed at one hour. The results suggest that imaging with [203Pb]VMT-α-NET at four hours post-injection has the best overall diagnostic performance, followed closely by imaging at one hour.
Also at SNMMI, an investigator reported on [212Pb]VMT-α-NET planning based on [203Pb]VMT-α-NET predictive dosimetry in an investigator-sponsored trial. The investigators applied patient-specific dosimetry in a Phase 0 imaging trial (NCT05111509) of [203Pb]VMT-a-NET and in the first cohort of a Phase 1 absorbed-dose escalation study (NCT06148636) of [212Pb]VMT-α-NET. Ten patients with β-peptide receptor radionuclide therapy (PRRT)-relapsed or refractory gastroenteropancreatic (GEP)-NETs received [203Pb]VMT-α-NET (5 mCi) followed by sequential blood sampling, planar imaging and qSPECT/CT imaging at 1 hour, 4 hours, 24 hours and 48 hours post-administration. Three of ten patients received amino acid infusions while seven patients did not receive amino acids.
The dosimetry showed that the average renal doses for patients who received amino acids was 0.46±0.20 Gy/mCi, as compared to 0.56±0.16 Gy/mCi for patients who did not receive amino acids; the difference was not statistically significant. For the three patients who received [212Pb]VMT-α-NET treatment, based upon their individual dosimetry results, they were prescribed 5.3, 7.3, and 13.3 mCi cumulative activity (delivered over two cycles), respectively, to reach the cohort target renal dose of 3.5 Gy. Higher levels of targeted renal-absorbed doses are in the protocol for subsequent cohorts.
Additionally at SNMMI, the lead investigator reported on an exploratory first-in-human use of [212Pb]VMT-α-NET in adult patients with histologically confirmed metastatic NETs and medullary thyroid carcinomas in an investigator-led research study in India. The investigator reported updated safety and anti-tumor activity of [212Pb]VMT-α-NET administered at 67 µCi/kg (2.5 MBq/kg) every eight weeks in 13 patients as of the data cut-off date of May 31, 2024. All patients received prior treatments, eight of whom received prior PRRT treatment. Six patients remained eligible for further treatments as of the data cut-off date.
The investigator concluded that the toxicity profile suggests the potential for dose escalation to achieve optimal treatment responses. Confirmed tumor response per RECIST 1.1 was reported to be observed in eight of the 13 patients, while unconfirmed responses were observed in two additional patients who eventually had progressive disease and died. Median progression free survival was reported to be 16.4 months (95% confidence interval: 3.5 to NA). The investigator also reported higher absorbed doses in the tumors compared to select other tissues.
Subsequently, in October 2024, at the 37th Annual Congress of the European Association of Nuclear Medicine in Hamburg, Germany, the investigator presented an update on a subset of the previously reported investigator-led research study in India. The cut-off date was September 15, 2024, and the study focused on 10 patients with well-differentiated GEP-NETs. These patients were treated with [212Pb]VMT-α-NET at a dosage of 67 µCi/kg (2.5 MBq/kg), with an interval of eight weeks for up to six cycles. Treatment was well tolerated with a modest and manageable adverse effect profile. Confirmed tumor response per RECIST 1.1 was observed in six of the 10 GEP-NETs patients. The investigator again concluded that the toxicity profile suggests the potential for dose escalation to achieve optimal treatment responses. Long-term survival data will mature with continued follow up.
Additionally, dosimetry estimates were collected from five of the 10 GEP-NETs patients discussed above. The results demonstrated that SPECT/CT imaging with [212Pb]VMT-α-NET showed prompt tumor accumulation, high tumor retention and rapid renal excretion in all patients. Overall, the findings suggest that post-treatment imaging of [212Pb]VMT-α-NET is feasible and can potentially serve as a valuable tool to evaluate and monitor patients through a full course of treatment.
VMT01
[212Pb]VMT01 is a TAT in development for second-line or later treatment of patients with progressive MC1R-positive metastatic melanoma. MC1R, or melanocortin 1 receptor, is a protein that can be overexpressed in metastatic melanoma. VMT01 can be radiolabeled with either 203Pb for patient selection and dosimetry assessments, or 212Pb for alpha-particle therapy. In preclinical experiments [212Pb]VMT01 demonstrated efficacy via two distinct mechanisms of action: direct cell killing at high radiation doses and through immunostimulatory low-dose induction of immune-mediated cell death. Efficacy was augmented by immune checkpoint inhibitors. In September 2024, we announced that on the basis of these results, the FDA granted Fast Track Designation for the clinical development of [212Pb]VMT01. This study is a multi-center, open-label dose escalation, dose expansion study (clinicaltrials.gov identifier NCT05655312) in patients with histologically confirmed melanoma and MC1R-positive imaging scans. Patients were required to have already received standard of care. Eligible patients may receive up to three treatments with [212Pb]VMT01, eight weeks apart.
In March 2024, we entered into a clinical trial collaboration with Bristol Myers Squibb to evaluate the safety and tolerability of [212Pb]VMT01 in combination with Bristol Myers Squibb’s checkpoint inhibitor nivolumab in patients with histologically confirmed melanoma and positive MC1R imaging scans. A protocol amendment was submitted in July 2024 to explore the combination of nivolumab with [212Pb]VMT01 in patients with histologically confirmed melanoma and positive MC1R imaging scans in our ongoing Phase 1/2a clinical study of [212Pb]VMT01.
In October 2024, we announced initial results from the first two dosing cohorts in our Phase 1/2a clinical study of [212Pb]VMT01. Three patients were enrolled in Cohort 1 (who received 3 mCi of [212Pb]VMT01), while seven patients were enrolled in Cohort 2 (who received 5 mCi of [212Pb]VMT01). Patients in each cohort received a median of five prior lines of systematic therapy, including a median of three prior lines of immunotherapy.
•Safety findings: No dose-limiting toxicities were observed among any patients, and no adverse events led to treatment discontinuation. Treatment emergent adverse events (TEAEs) were mostly Grades 1 and 2. None of the four cases of grade 3 TEAEs were deemed to be treatment related. There were no grade 4 or 5 TEAEs. No renal toxicities had been reported as of October 11, 2024 (there were no clinically significant changes in blood urea nitrogen or serum creatinine) in spite of dosimetry estimated renal radiation that approached the higher end of conventional dosing.
•Efficacy findings: All patients in Cohort 1 completed three treatments, with one patient experiencing an unconfirmed RECIST version 1.1 objective response after completion of treatment, and two patients experiencing stable disease at nine and 11 months from the start of treatment, respectively. In Cohort 2, patients progressed after either the first cycle (three patients) or the second cycle (four patients). These findings are consistent with published and ongoing preclinical studies showing immunostimulatory effects at lower radiation doses.
The SMC reviewed these findings and recommended exploring a lower dose level of 1.5 mCi per dose, both as a single agent and in combination with nivolumab. The SMC recommendation would allow for the monotherapy and combination cohorts to proceed concurrently. An amendment to further explore lower dose levels for monotherapy is planned. The combination cohort at 1.5 mCi per dose with nivolumab is active and now open for enrollment.
PSV359
In March 2024, we disclosed a novel pre-IND stage asset (PSV359) that targets fibroblast activation protein-α, which is associated with a variety of solid tumors. We are currently working on an IND for PSV359 which we expect to file in late 2024. If the study may proceed, we expect that the U.S. Phase 1 study would commence in 2025.
On June 10, 2024, at the Society of Nuclear Medicine and Molecular Imaging 2024 Annual Meeting, researchers presented a novel fibroblast activation protein (FAP), which is a protein abundantly expressed in certain cancer cells as well as cancer-associated fibroblasts in tumor lesions and involved in promoting disease progression. The peptide was conjugated to a Pb-specific chelator via a molecular linker to form a novel construct, PSV359. The purpose of this study was to evaluate the in vitro and in vivo performance of [203/212Pb]PSV359 in preclinical xenograft models. Overall, strong anti-tumor clinical activity of [212Pb]PSV359 was found in both FAP on cancer cells and FAP in stromal tissues xenograft models.
During an update at the World Molecular Imaging Congress on September 10, 2024, we announced that data substantiated favorable safety and strong efficacy profiles in preclinical studies of our novel human FAP-targeting candidate, PSV359. During preclinical evaluation of [203/212Pb]PSV359 for imaging and alpha-particle therapy of cancers expressing FAP, the researcher found that in vitro, [203/212Pb]PSV359 demonstrated superior FAP-binding affinity and specificity, and that [203Pb]PSV359 showed strong tumor uptake and clearance from the blood via the renal system. In the study, [212Pb]PSV359 also showed strong anti-tumor effects in xenograft models in which FAP was either on cancer cells or in stromal tissues.
Other
Data presented at the World Molecular Imaging Congress in September 2024 also demonstrated the need for customized chelators to maximize stability and targeted delivery of potent alpha-particles. With the support of computational modeling, investigators used multiple chelators that are commonly used in radionuclide therapy, along with alpha emitters, beta emitters and imaging tracers, to determine compatibility between chelators and radionuclides. The study confirmed that modified chelators demonstrated superior performance when compared to conventional chelators.
Pre-targeting technology is designed to enable the use of antibodies to direct radiolabeled ligands to tumor sites. Antibodies can bind with high specificity to a wider variety of cancer-specific proteins preferentially expressed on the surface of tumor cells. However, the amount of time required for an adequate amount of antibodies to bind to the cancer-specific proteins may not align with the properties of the desired isotope. By attaching an additional chemical entity to an antibody that would bind to a radioligand, the resultant modified antibodies may be administered separately from and in advance of the radioligand as appropriate. Preclinical optimization of this platform is underway, and initial targeting antibodies have been identified for further investigation.
In January 2024, we announced that we have a license agreement with Mayo Clinic for the rights to Mayo's prostate-specific membrane antigen (PSMA) Alpha-PET DoubLET platform technology for the treatment of PSMA-expressing cancers, with an initial focus on prostate. This radiopharmaceutical platform provides detailed PET imaging-based diagnosis and dosimetry using long-lived Cu-64 for imaging and alpha-particle targeted therapies using 212Pb. Preclinical studies are ongoing to assess whether this new molecular entity meets the hurdle for progressing into the clinic with potential to achieve best-in-class profile.
Also in January 2024, we entered into an exclusive in-licensing of Stony Brook University’s Cuburbit[7]uril-admantane (CB7-Adma) pre-targeting platform which covers the global intellectual property rights to such platform. Pre-targeting using the CB7-Adma platform involves two steps. First, an antibody that binds with high specificity to a cancer-specific protein is administered via intravenous injection. This antibody is chemically modified to include the CB7 chemical entity and accumulates over time at the tumor site. Then, a radionuclide held tightly by our proprietary chelator attached to an Adma group is administered. The Adma group binds to the CB7 group that was previously attached to the cancerous cells with remarkable specificity, delivering radiation dose selectively to the tumor sites. Central to this innovation is CB7-Adma (host-guest) complex formation, driving the interaction between the antibody and radioligand. The chosen host-guest pair, CB7-Adma, demonstrates promising in vivo stability, modularity and low immunogenicity. The platform’s potential was validated through in vivo profiling of ligands, employing a CB7-modified CEA targeting antibody. The agreement with Stony Brook University will expire on the later of the expiration date of the last to expire licensed patents or 20 years from the date of the first sale of a product utilizing the intellectual property.
Intellectual Property (IP)
Two patents have recently been granted on key assets for which we have exclusive licenses from the University of Iowa. US 12,128,115, granted by the United States Patent and Trademark Office on October 29, 2024, is directed to the use of compounds comprising PSC for performing chelating reaction with divalent metals, including Pb2+, and the use of such compounds for diagnosing and treating diseases. AU 2017281940, granted by IP Australia on October 31, 2024, is directed to melanoma-targeting radiopharmaceutical compounds and the use of such compounds for treating melanoma. Both patents further strengthen our IP portfolio.
Funding Requirements
We have had recurring losses since inception. We expect our expenses to increase in connection with our ongoing activities, particularly as we advance and expand preclinical activities, clinical trials and potential commercialization of our program candidates. Our costs will also increase as we:
•continue the development of our clinical-stage metastatic melanoma tumor and neuroendocrine tumor assets, including VMT01 and VMT-α-NET;
•continue the development of our other program candidates;
•continue to initiate and progress other supporting studies required for regulatory approval of our program candidates;
•initiate preclinical studies and clinical trials for any additional indications for our current program candidates and any future program candidates that we may pursue;
•continue to build our portfolio of program candidates through the acquisition or in-license of additional program candidates or technologies;
•continue to develop, maintain, expand and protect our intellectual property portfolio;
•pursue regulatory approvals for our current and future program candidates that successfully complete clinical trials;
•continue to build our manufacturing capabilities;
•support our marketing and distribution infrastructure to commercialize any future program candidates for which we may obtain marketing approval; and
•hire additional clinical, medical, development and other personnel.
As of September 30, 2024, we had cash, cash equivalents and short-term investments of $267.8 million. We believe our cash, cash equivalents and short-term investments will be sufficient to fund our current planned operations for at least the next 12 months from the date the consolidated financial statements in this report were issued and into mid-2026. Monthly operating expenses are budgeted to increase for research and development and general and administrative expenses as management works to implement its strategy to advance our clinical assets in their clinical trials and to progress our preclinical assets towards clinical trials. Management anticipates a significant increase in expenses, particularly in research and development, as we undertake these activities.
Manufacturing Equipment
On September 18, 2024, we entered into a Master Equipment and Services Agreement (MESA) and statements of work (SOWs) thereunder with Comecer SpA (Comecer), pursuant to which we agreed to purchase from Comecer manufacturing equipment for the production of our radiopharmaceutical products including, but not limited to, isotope processing hot cells and production suites and related equipment (collectively, the Deliverables) and services for installation and validation of the Deliverables at several of our production facilities in the United States. The aggregate consideration for such equipment and services pursuant to the MESA and SOWs is approximately €49.0 million payable in cash, excluding certain incidental costs such as taxes, customs and duties, local transport, insurance and rigging. We may also elect to purchase certain additional equipment and services pursuant to the SOWs. The MESA provides for the payment of certain amounts in installments over the course of the production, installation and validation of the Deliverables.
Facility Acquisitions
On July 15, 2024, August 2, 2024 and October 31, 2024, we purchased a building located in the Houston, Texas, metropolitan area for $4.7 million, a building in the Chicago, Illinois, metropolitan area for $5.0 million, and a building in the Los Angeles, California, metropolitan area for $11.0 million, respectively, which we intend to use for the manufacture of our program candidates upon completion of modifications and installation of equipment.
In March 2024, we acquired the assets and associated lease of Lantheus’ radiopharmaceutical manufacturing facility in Somerset, New Jersey. We believe we will be able to convert the facility, which has three production suites, to manufacture finished radiopharmaceutical product. As a Current Good Manufacturing Practice (CGMP) compliant facility, we intend to utilize the facility to manufacture clinical supply of high quality 203Pb-labeled tumor-specific peptides to visualize and diagnose tumors, and 212Pb-labeled radiopharmaceuticals to treat target tumors with TAT. As of October 2024, this facility is operational to supply investigational products to support VMT-α-NET clinical studies, in addition to the Coralville, Iowa facility which has been producing our investigational products since 2023. Moreover, with three CGMP suites at the facility, we expect to have the capacity to meet future clinical trial and commercial demands at major cancer treatment centers throughout the Northeastern U.S. We intend to continue to expand our manufacturing and supply network in the future as we anticipate increasing our clinical trial activities.
We continue to evaluate the suitability of additional facilities as we look to expand our research and development capabilities.
2024 At-the-Market (ATM) Agreement
On August 13, 2024, we entered into a Controlled Equity OfferingSM Sales Agreement (2024 ATM Agreement) with Cantor Fitzgerald & Co. and RBC Capital Markets, LLC (each, an ATM Agent, and together, the ATM Agents) pursuant to which we, from time to time, may offer and sell shares (2024 ATM Shares) of our Common Stock, through or to the ATM Agents having an aggregate sales price of up to $250.0 million.
Subject to the terms and conditions of the 2024 ATM Agreement, each ATM Agent is required to use its commercially reasonable efforts to sell the ATM Shares from time to time, based upon our instructions. We have provided the ATM Agents with customary indemnification rights, and the ATM Agents will be entitled to a commission of up to 3.0% of the gross proceeds from each sale of the ATM Shares effectuated through or to the applicable ATM Agent selling the ATM Shares.
Sales of the 2024 ATM Shares, if any, under the 2024 ATM Agreement may be made in transactions that are deemed to be “at the market offerings” as defined in Rule 415 under the Securities Act of 1933, as amended. We have no obligation to sell any of the 2024 ATM Shares and may at any time suspend offers under the 2024 ATM Agreement or terminate the 2024 ATM Agreement.
The Common Stock to be sold under the 2024 ATM Agreement, if any, will be issued and sold pursuant to our automatic shelf registration statement on Form S-3 (File No. 333-279692) (the May 2024 Registration Statement), which became effective upon filing with the SEC on May 24, 2024. On August 13, 2024, we filed a prospectus supplement to the May 2024 Registration Statement with the SEC in connection with the offer and sale of the 2024 ATM Shares pursuant to the 2024 ATM Agreement.
As of September 30, 2024, we have not completed any transactions pursuant to the 2024 ATM Agreement.
Amended and Restated Equity Incentive Plan
On May 31, 2024, we held our 2024 Annual Meeting of Stockholders (Annual Meeting). At the Annual Meeting, our stockholders approved our Third Amended and Restated 2020 Equity Incentive Plan (the Amended and Restated Plan) which, among other things, (a) increased the aggregate number of shares of Common Stock authorized for issuance under the Amended and Restated Plan by 4,870,092 for a total of 12,500,000 shares of Common Stock, and (b) adjusted the “evergreen” provision included therein, such that the number of shares of Common Stock available for the grant of awards under the Amended and Restated Plan will automatically increase on January 1 of each year in an amount equal to 5% of the number of shares of Common Stock issued and outstanding on December 31 of the immediately preceding year (subject to adjustment in the event of stock splits and other similar events); provided, however, that our Board of Directors may act prior to January 1 of a given year to provide that there will be no increase in the share limit for such year or provide that the increase for such year will be a lesser number of shares of Common Stock. On August 14, 2024, we filed a Form S-8 to register 4,870,092 additional shares of Common Stock authorized for issuance under the Amended and Restated Plan as approved by stockholders at the Annual Meeting.
Brachytherapy Divestiture
On April 12, 2024 (GT Medical Closing Date), we completed the sale of substantially all of the assets (GT Medical Closing) of Isoray to GT Medical Technologies, Inc. (GT Medical). As previously disclosed, on December 7, 2023, we entered into an Asset Purchase Agreement (the GT Medical APA) with Isoray and GT Medical. Pursuant to the GT Medical APA, Isoray sold to GT Medical, and GT Medical purchased from Isoray, all of Isoray’s right, title and interest in and to substantially all of the assets of Isoray related to Isoray’s
commercial Cesium-131 business including equipment, certain contracts and leases, inventory and intellectual property. Subject to limited exceptions set forth in the GT Medical APA, GT Medical did not assume the liabilities of Isoray.
Pursuant to the terms of, and subject to the conditions specified in, the GT Medical APA, at the GT Medical Closing, (i) GT Medical issued to Isoray 279,516 shares of GT Medical’s common stock, par value $0.0001 per share, representing 0.5% of GT Medical’s issued and outstanding capital stock on a fully diluted basis (excluding Series C-1 warrants which, if exercised, will reduce Isoray’s ownership to 0.44% of GT Medical’s issued and outstanding capital stock on a fully diluted basis) as of the GT Medical Closing Date and (ii) Isoray has the right to receive, and GT Medical is obligated to pay, certain cash royalty payments during each of the first four years beginning upon the GT Medical Closing Date (each such year, a Measurement Period), as summarized below:
•with respect to GT Medical’s net sales of Cesium-131 brachytherapy seeds for cases that do not utilize GT Medical’s GammaTile Therapy: (a) if such net sales for a Measurement Period are $10.0 million or less, 3.0% of such net sales; (b) if such net sales for a Measurement Period are greater than $10.0 million and less than $15.0 million, 4.0% of such net sales; and (c) if such net sales for a Measurement Period are $15.0 million or more, 5.0% of such net sales; and
•with respect to GT Medical’s net sales of GT Medical’s GammaTile Therapy utilizing Cesium-131 brachytherapy seeds: 0.5% of such net sales for a Measurement Period.
As a result of the transaction, we have effectively exited the brachytherapy segment and are focused exclusively on our radiopharmaceutical development segment, our only operating segment and reporting segment. The sale of the brachytherapy segment represents a strategic shift that had a major effect on our operations. We accounted for the transaction as discontinued operations on the date the divestiture was announced. Accordingly, we are reporting the results of the brachytherapy segment operations and cash flows, and balance sheet classifications for the current and comparative periods as discontinued operations. Prior to the consummation of the sale, we were neither actively marketing the brachytherapy business for sale nor had intentions to abandon it.
For additional information regarding our brachytherapy divestiture, see our Forms 8-K filed with the SEC on December 12, 2023, April 3, 2024 and April 16, 2024.
Viewpoint Merger
On February 3, 2023, we completed the merger of Isoray Acquisition Corp., a Delaware corporation and wholly owned subsidiary of ours, with Viewpoint Molecular Targeting, Inc. (Viewpoint) (such transaction being the Merger). Pursuant to the Merger, we issued 13,654,507 shares of Common Stock, representing approximately 49% of our fully diluted outstanding capital stock as of the closing of the Merger. Viewpoint is developing the next generation of precision-targeted alpha therapies (TAT) for oncology that have the potential to treat a large population of cancer patients across multiple tumor types, including those with metastatic disease.
For additional information regarding the Merger, see our Forms 8-K filed with the SEC on September 28, 2022 and on February 6, 2023, and our Form 8-K/A filed with the SEC on April 21, 2023.
Critical Accounting Policies and Estimates
The discussion and analysis of our financial condition and results of operations are based upon our condensed consolidated financial statements, which have been prepared in accordance with generally accepted accounting principles in the United States. The preparation of these condensed consolidated financial statements requires management to make estimates and judgments that affect the reported amounts of assets, liabilities, revenues and expenses, and related disclosure of contingent liabilities. Actual results may differ from these estimates under different assumptions or conditions and could, therefore, differ materially from those estimates if actual conditions differ from our assumptions. The accounting policies and related risks described in Part II, Item 7 and Note 2, Accounting Policies, to the consolidated financial statements included in Part II, Item 8 of our 2023 Form 10-K are those that depend most heavily on these judgments and estimates. As of September 30, 2024, there have been no material changes to any of the critical accounting policies and estimates contained therein.
Results of Operations
We previously presented our results in two segments: Drug Operations and Brachytherapy. Due to the sale of our brachytherapy segment to GT Medical in the second quarter of 2024 and the classification of the assets and operations of the brachytherapy segment as discontinued operations in our condensed consolidated financial statements, we have now determined that we operate in only one segment. The following does not include a discussion of the results of our discontinued operations. For additional information regarding our discontinued operations, see Note 4, Discontinued Operations, to the condensed consolidated financial statements in this Form 10-Q.
The following table sets forth our results of operations for the periods presented (in thousands):
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|
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|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended September 30, |
|
|
|
|
|
Nine Months Ended September 30, |
|
|
|
|
|
|
2024 |
|
|
2023 |
|
|
Change |
|
|
2024 |
|
|
2023 |
|
|
Change |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Grant revenue |
|
$ |
369 |
|
|
$ |
276 |
|
|
$ |
93 |
|
|
$ |
1,220 |
|
|
$ |
1,097 |
|
|
$ |
123 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Operating expenses: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Research and development expenses |
|
|
12,028 |
|
|
|
5,552 |
|
|
|
6,476 |
|
|
|
28,755 |
|
|
|
14,231 |
|
|
|
14,524 |
|
General and administrative expenses |
|
|
6,975 |
|
|
|
4,474 |
|
|
|
2,501 |
|
|
|
18,367 |
|
|
|
16,124 |
|
|
|
2,243 |
|
Change in estimate of asset retirement obligation (Note 4) |
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
(15 |
) |
|
|
15 |
|
Loss on disposal of property and equipment |
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
22 |
|
|
|
(22 |
) |
Total operating expenses |
|
|
19,003 |
|
|
|
10,026 |
|
|
|
8,977 |
|
|
|
47,122 |
|
|
|
30,362 |
|
|
|
16,760 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Operating loss |
|
$ |
(18,634 |
) |
|
$ |
(9,750 |
) |
|
$ |
(8,884 |
) |
|
$ |
(45,902 |
) |
|
$ |
(29,265 |
) |
|
$ |
(16,637 |
) |
Grant Revenue
Our alpha-therapy business is pre-revenue and, accordingly, none of the revenues reflect sales of any of our alpha-therapy products, which are still under development. Grant revenue for all periods presented relates to our work for the National Institutes of Health.
Operating Expenses
Research and development
Research and development expenses were $12.0 million for the three months ended September 30, 2024, compared to $5.6 million for the three months ended September 30, 2023, an increase of $6.4 million. Research and development expenses were $28.8 million for the nine months ended September 30, 2024, compared to $14.2 million for the nine months ended September 30, 2023, an increase of $14.6 million. The increase in research and development expenses was related to the expanded development of our TAT drug programs, including higher personnel costs and third-party research and development fees.
Management believes that research and development expenses will continue to increase as we continue to invest in the development of novel radiopharmaceutical drugs and products and expand our manufacturing capabilities.
General and administrative
General and administrative expenses consist primarily of the costs related to our executive, finance, human resources and information technology functions.
General and administrative expenses were $7.0 million for the three months ended September 30, 2024, compared to $4.5 million for the three months ended September 30, 2023, an increase of $2.5 million. The increase in general and administrative expenses during the three months ended September 30, 2024 was primarily due to increased personnel costs as well as increased fees for professional services, taxes and insurance.
General and administrative expenses were $18.4 million for the nine months ended September 30, 2024, compared to $16.1 million for the nine months ended September 30, 2023, an increase of $2.3 million. The increase in general and administrative expenses for the nine months ended September 30, 2024 was primarily due to increased personnel costs as well as increased fees for professional services, taxes and insurance.
Liquidity and Capital Resources
We assess our liquidity in terms of our ability to generate cash to fund our operating, investing and financing activities. We have historically financed our operations primarily through selling equity to investors. During the nine months ended September 30, 2024, we entered into various agreements and raised approximately $306.7 million in gross proceeds. The following table summarizes our cash flows for the periods presented (in thousands):
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|
|
|
|
|
|
|
|
Nine Months Ended September 30, |
|
|
|
2024 |
|
|
2023 |
|
Net cash provided by (used in) operating activities |
|
$ |
8,312 |
|
|
$ |
(27,905 |
) |
Net cash (used in) provided by investing activities |
|
|
(80,329 |
) |
|
|
24,462 |
|
Net cash provided by financing activities |
|
|
289,040 |
|
|
|
433 |
|
Net increase (decrease) in cash and cash equivalents |
|
$ |
217,023 |
|
|
$ |
(3,010 |
) |
Cash flows from operating activities
Net cash provided by operating activities of $8.3 million in the nine months ended September 30, 2024, was primarily due to amounts received pursuant to that certain option agreement, dated January 8, 2024, of $28.0 million, between us and Lantheus Alpha Therapy, LLC, an increase of $14.9 million in accounts payable and accrued expenses, and an increase of $4.2 million in non-cash charges such as share-based compensation and depreciation expense, partially offset by a net loss of approximately $39.1 million.
Net cash used in operating activities of $27.9 million in the nine months ended September 30, 2023, was primarily due to a net loss of approximately $21.8 million and approximately $6.4 million in adjustments for non-cash activities, such as share-based compensation, depreciation and amortization expense, loss on property and equipment disposals, and changes in deferred taxes, partially offset by an increase of approximately $0.3 million in changes in operating assets and liabilities, primarily from accrued personnel expenses.
Cash flows from investing activities
Net cash used in investing activities of $80.3 million in the nine months ended September 30, 2024, was primarily due to acquisitions of property and equipment and purchases of U.S. Treasury Bills, partially offset by proceeds from the maturity of these previously held short-term investments.
Net cash provided by investing activities of $24.5 million in the nine months ended September 30, 2023, was primarily due to transactions related to the purchase of fixed assets and proceeds from the maturity of previously held short-term investments in U.S. Treasury Bills and cash acquired as part of the merger with Viewpoint.
Cash flows from financing activities
Net cash provided by financing activities of $289.0 million in the nine months ended September 30, 2024, was primarily related to the various capital markets transactions and other agreements we entered into, partially offset by repayment of a note payable. For additional information regarding the cash we raised, see Sources of Liquidity below.
Net cash provided by financing activities of $0.4 million in the nine months ended September 30, 2023, was primarily related to cash provided by the exercise of stock options of approximately $0.6 million, partially offset by the costs related to Common Stock issued in exchange for Viewpoint common stock and the repayment of notes payable.
Sources of Liquidity
2024 At-the-Market (ATM) Agreement
On August 13, 2024, we entered into a Controlled Equity OfferingSM Sales Agreement (2024 ATM Agreement) with Cantor Fitzgerald & Co. and RBC Capital Markets, LLC (each, an ATM Agent, and together, the ATM Agents) pursuant to which we, from time to time, may offer and sell shares (2024 ATM Shares) of our Common Stock, through or to the ATM Agents having an aggregate sales price of up to $250.0 million.
Subject to the terms and conditions of the 2024 ATM Agreement, each ATM Agent is required to use its commercially reasonable efforts to sell the ATM Shares from time to time, based upon our instructions. We have provided the ATM Agents with customary indemnification rights, and the ATM Agents will be entitled to a commission of up to 3.0% of the gross proceeds from each sale of the ATM Shares effectuated through or to the applicable ATM Agent selling the ATM Shares.
Sales of the 2024 ATM Shares, if any, under the 2024 ATM Agreement may be made in transactions that are deemed to be “at the market offerings” as defined in Rule 415 under the Securities Act of 1933, as amended. We have no obligation to sell any of the 2024 ATM Shares and may at any time suspend offers under the 2024 ATM Agreement or terminate the 2024 ATM Agreement.
The Common Stock to be sold under the 2024 ATM Agreement, if any, will be issued and sold pursuant to our automatic shelf registration statement on Form S-3 (File No. 333-279692) (the May 2024 Registration Statement), which became effective upon filing with the SEC on May 24, 2024. On August 13, 2024, we filed a prospectus supplement to the May 2024 Registration Statement with the SEC in connection with the offer and sale of the 2024 ATM Shares pursuant to the 2024 ATM Agreement.
As of September 30, 2024, we have not completed any transactions pursuant to the 2024 ATM Agreement.
May 2024 Registered Offering
On May 24, 2024, we entered into an underwriting agreement with BofA Securities, Inc., as representative of the underwriters named therein, in connection with its previously announced underwritten offering (Registered Offering) of 5,151,588 shares (Registered Offering Shares) of our Common Stock and, in lieu of Registered Offering Shares to certain investors, pre-funded warrants (May 2024 Pre-funded Warrants) to purchase 146,425 shares of Common Stock. The price to the investors for the Registered Offering Shares was $15.10 per Registered Offering Share, and the price to the investors for the May 2024 Pre-funded Warrants was $15.09 per May 2024 Pre-funded Warrant, which represents the per share price for the Registered Offering Shares less the $0.01 per share exercise price for each such May 2024 Pre-funded Warrant. The Registered Offering closed on May 29, 2024. BofA Securities, Inc., Oppenheimer & Co. Inc. and RBC Capital Markets, LLC acted as joint book-running managers for the Registered Offering and B. Riley Securities, Inc. acted as a co-manager for the Registered Offering. JonesTrading Institutional Services LLC acted as a financial advisor for the Registered Offering.
Our gross proceeds from the Registered Offering were approximately $80.0 million, before underwriting discounts and commissions and estimated expenses of the Offering. We intend to use the net proceeds from the Registered Offering for: (i) the continued clinical development of VMT-α-NET, VMT-01/02 and PSV359; (ii) the continued development of PSV40X and additional preclinical product candidates as well as a broader development platform; and (iii) the build out, operation and expansion of manufacturing facilities, as well as for working capital and other general corporate purposes. A portion of the net proceeds may also be used to acquire, license or invest in complementary products, technologies, intellectual property or businesses, although we have no present commitments or agreements to do so.
The May 2024 Pre-funded Warrants became exercisable subsequent to the filing and effectiveness of an amendment to our Amended and Restated Certificate of Incorporation with the Secretary of State of the State of Delaware on June 14, 2024. The exercise price and the number of shares of Common Stock issuable upon exercise of each May 2024 Pre-funded Warrant are subject to appropriate adjustment in the event of certain stock dividends and distributions, stock splits, stock combinations, reclassifications or similar events affecting the Common Stock as well as upon any distribution of assets, including cash, stock or other property, to our stockholders. The May 2024 Pre-funded Warrants will not expire and are exercisable in cash or by means of a cashless exercise. A holder of May 2024 Pre-funded Warrants may not exercise such May 2024 Pre-funded Warrants if the aggregate number of shares of Common Stock beneficially owned by such holder, together with its affiliates, would be more than 4.99% or 9.99%, as elected by such holder, of the issued and outstanding shares of Common Stock following such exercise, as such percentage ownership is determined in accordance with the terms of the May 2024 Pre-funded Warrants. A holder of May 2024 Pre-funded Warrants may increase or decrease this percentage not in excess of 19.99% by providing at least 61 days’ prior notice to us.
On April 11, 2024, we sold shares of our Common Stock pursuant to that certain At Market Issuance Sales Agreement (ATM Agreement), dated as of November 17, 2023, by and among us, Oppenheimer & Co. Inc., B. Riley Securities, Inc. and JonesTrading Institutional Services LLC. The sales resulted in gross proceeds to us of approximately $49.5 million. For additional information regarding the ATM Agreement, see our Form S-3 filed on November 17, 2023 and Form S-3/A filed on December 7, 2023.
March 2024 Private Placement with Institutional Investors
On March 4, 2024, we entered into an investment agreement with certain accredited institutional investors pursuant to which we agreed to issue and sell, in a private placement (March 2024 Private Placement), 9,200,998 shares of our Common Stock, for a purchase price of $9.50 per share, representing the closing price of the Common Stock on March 1, 2024. The closing of the March 2024 Private Placement occurred on March 6, 2024. The gross proceeds to us from the March 2024 Private Placement were approximately $87.4 million, before deducting fees and other estimated transaction expenses.
Investment Agreement
On January 8, 2024, we entered into an investment agreement (Lantheus Investment Agreement) with Lantheus Alpha Therapy, LLC, a Delaware limited liability company and wholly owned subsidiary of Lantheus Holdings, Inc. (Lantheus), pursuant to which we agreed to sell and issue to Lantheus in a private placement transaction certain shares (Lantheus Shares) of our Common Stock. The closing of the purchase and sale of the Lantheus Shares to Lantheus by us (Lantheus Closing) was subject to us raising at least $50.0 million of gross proceeds (excluding Lantheus’ investment) in a qualifying third-party financing transaction, which occurred on January 22, 2024. The number of Lantheus Shares sold was 5,634,235, representing 19.99% of the outstanding shares of Common Stock as of January 8, 2024. Pursuant to the Lantheus Investment Agreement, we agreed to cooperate in good faith to negotiate and enter into a registration rights agreement with Lantheus, obligating us to file a registration statement on Form S-3 with the SEC to register for resale the Lantheus Shares issued at the Lantheus Closing. We filed such Form S-3 on March 29, 2024, and the SEC declared it effective on April 9, 2024 (File No. 333-278362). The Lantheus Investment Agreement also contains agreements between us and Lantheus whereby Lantheus is provided certain board observer and information rights of us, as well as standstill provisions prohibiting Lantheus from taking certain actions for a specified period of time, subject to certain exceptions.
January 2024 Public Offering
On January 17, 2024, we entered into an underwriting agreement (Underwriting Agreement) with Oppenheimer & Co. Inc., as representative of the underwriters named therein (Underwriters), in connection with our underwritten public offering (Public Offering) of 13,207,521 shares (Public Shares) of our Common Stock and in lieu of Public Shares to certain investors, pre-funded warrants (Jan. 2024 Pre-funded Warrants) to purchase 3,008,694 shares of Common Stock. The price to the public for the Public Shares was $3.70 per Public Share, and the price to the public for the Jan. 2024 Pre-funded Warrants was $3.69 per Jan. 2024 Pre-funded Warrant, which represents the per share price for the Public Shares less the $0.01 per share exercise price for each such Jan. 2024 Pre-funded Warrant. Under the terms of the Underwriting Agreement, we granted the Underwriters an option, exercisable for 30 days, to purchase up to an additional 2,432,432 shares of Common Stock at the same price per share as the Public Shares, which such option was fully exercised by the Underwriters on January 18, 2024. The Public Offering closed on January 22, 2024.
The gross proceeds to us from the Public Offering were approximately $69.0 million, before underwriting discounts and commissions and estimated expenses of the Public Offering.
The Public Offering was made pursuant to our shelf registration statement on Form S-3 (File No. 333-275638), declared effective by the SEC on December 14, 2023, a base prospectus dated December 14, 2023, and the related prospectus supplement dated January 17, 2024.
The Jan. 2024 Pre-funded Warrants are exercisable at any time after the date of issuance. The exercise price and the number of shares of Common Stock issuable upon exercise of each Jan. 2024 Pre-funded Warrant are subject to appropriate adjustment in the event of certain stock dividends and distributions, stock splits, stock combinations, reclassifications or similar events affecting the Common Stock as well as upon any distribution of assets, including cash, stock or other property, to our stockholders. The Jan. 2024 Pre-funded Warrants will not expire and are exercisable in cash or by means of a cashless exercise. A holder of Jan. 2024 Pre-funded Warrants may not exercise such Jan. 2024 Pre-funded Warrants if the aggregate number of shares of Common Stock beneficially owned by such holder, together with its affiliates, would beneficially own more than 4.99% of the issued and outstanding shares of Common Stock following such exercise, as such percentage ownership is determined in accordance with the terms of the Jan. 2024 Pre-funded Warrants. A holder of Jan. 2024 Pre-funded Warrants may increase or decrease this percentage not in excess of 19.99% by providing at least 61 days’ prior notice to us.
Funding Requirements
We expect our expenses to increase in connection with our ongoing activities, particularly as we advance and expand preclinical activities, clinical trials and potential commercialization of our program candidates. Our costs will also increase as we:
•continue the development of our clinical-stage metastatic melanoma tumor and neuroendocrine tumor assets, including VMT01 and VMT-α-NET;
•continue the development of our other program candidates;
•continue to initiate and progress other supporting studies required for regulatory approval of our program candidates;
•initiate preclinical studies and clinical trials for any additional indications for our current program candidates and any future program candidates that we may pursue;
•continue to build our portfolio of program candidates through the acquisition or in-license of additional program candidates or technologies;
•continue to develop, maintain, expand and protect our intellectual property portfolio;
•pursue regulatory approvals for our current and future program candidates that successfully complete clinical trials;
•continue to build our manufacturing capabilities;
•support our marketing and distribution infrastructure to commercialize any future product candidates for which we may obtain marketing approval; and
•hire additional clinical, medical, development and other personnel.
At September 30, 2024, we had cash, cash equivalents and short-term investments of $267.8 million. We believe our cash, cash equivalents and short-term investments will be sufficient to fund our current planned operations and capital investments into mid-2026. Monthly operating expenses are budgeted to increase for research and development and general and administrative expenses as management works to implement our strategy to advance our clinical assets in our clinical trials and to progress our preclinical assets towards clinical trials. Management anticipates a significant increase of expenses, particularly in research and development, as we undertake these activities.
We expect we will need to raise additional capital until we are profitable, which may never occur. If no additional capital is raised through either additional public or private equity financings, debt financings, strategic relationships, alliances and licensing agreements, or a combination thereof, we may delay, limit or reduce discretionary spending in areas related to research and development activities and other general and administrative expenses in order to fund our operating costs and working capital needs.
We have based these estimates on assumptions that may prove to be wrong, and we could utilize our available capital resources sooner than we expect. We expect that we will require additional capital to pursue in-licenses or acquisitions of other program candidates. If we receive regulatory approvals for our program candidates, we expect to incur commercialization expenses related to program manufacturing, sales, marketing and distribution, depending on where we choose to commercialize or whether we commercialize jointly or on our own.
Because of the numerous risks and uncertainties associated with research, development and commercialization of our program candidates, we are unable to estimate the exact amount of our working capital requirements. Our future funding requirements will depend on and could increase significantly as a result of many factors, including:
•the scope, progress, results and costs of researching and developing our program candidates, and conducting preclinical studies and clinical trials;
•the costs, timing and outcome of regulatory review of our program candidates;
•the costs and timing of hiring new employees to support our continued growth;
•the costs of preparing, filing, and prosecuting patent applications, maintaining and enforcing our intellectual property rights and defending intellectual property-related claims;
•the extent to which we acquire or in-license other program candidates and technologies; and
•our ability to generate cash, and successfully obtain additional working capital, to fund our operating, investing and financing activities.
Until such time, if ever, that we can generate program revenue sufficient to achieve profitability, we expect to finance our cash needs through a combination of public and private equity offerings, debt financings, other third-party funding, strategic alliances, licensing arrangements or marketing and distribution arrangements. To the extent that we raise additional capital through the sale of equity or convertible debt securities, the ownership interest of our existing stockholders will be diluted, and the terms of these securities may include liquidation or other preferences that adversely affect the rights of our existing stockholders. Debt financing and preferred equity financing, if available, may involve agreements that include covenants limiting or restricting our ability to take specific actions, such as incurring additional debt, making capital expenditures or declaring dividends. If we raise additional funds through other third-party funding, strategic alliances, licensing arrangements, outright sales of program candidates or marketing and distribution arrangements, we may have to relinquish valuable rights to our technologies, future revenue streams, research programs or product candidates or grant licenses on terms that may not be favorable to us. If we are unable to raise additional funds through equity or debt financings when needed, we will be required to delay, limit, reduce or terminate our program development or future commercialization efforts or grant rights to develop and market programs or program candidates that we would otherwise prefer to develop and market ourselves.
Capital expenditures
Management is reviewing all aspects of research and development and general and administrative functions to evaluate the most efficient deployment of capital to ensure that the appropriate materials, systems and personnel are available to support and drive clinical trials and preclinical activities.
Financing activities
When we do require capital in the future, we expect to finance our cash needs through sales of equity, possible strategic collaborations, debt financing or through other sources that may be dilutive to existing stockholders. Management anticipates that if it raises additional financing that it will be at a discount to the market price and it will be dilutive to stockholders.
Other Commitments and Contingencies
We presented our other commitments and contingencies in our 2023 Form 10-K for the period ended December 31, 2023. There have been no material changes outside of the ordinary course of business in those obligations during the nine months ended September 30, 2024, other than those disclosed in Note 10, Commitments and Contingencies, to the condensed consolidated financial statements in this Form 10-Q.
Off-Balance Sheet Arrangements
We have no off-balance sheet arrangements.
ITEM 3 – QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK
We are a smaller reporting company, as defined by Rule 12b-2 under the Securities Exchange Act of 1934, as amended (the Exchange Act), and are not required to provide the information required under this item.
ITEM 4 – CONTROLS AND PROCEDURES
Evaluation of Disclosure Controls and Procedures
Under the supervision and with the participation of our management, including our principal executive officer and principal financial officer, we conducted an evaluation of the design and operation of our disclosure controls and procedures, as such term is defined under Rules 13a-15(e) and 15d-15(e) under the Exchange Act, as of September 30, 2024. Based on that evaluation, our principal executive officer and our principal financial officer concluded that the design and operation of our disclosure controls and procedures were effective. The design of any system of controls is based in part upon certain assumptions about the likelihood of future events, and there can be no assurance that any design will succeed in achieving its stated goals under all potential future conditions, regardless of how remote. However, management believes that our system of disclosure controls and procedures are designed to provide a reasonable level of assurance that the objectives of the system will be met.
Changes in Internal Control over Financial Reporting
There have not been any changes in our internal control over financial reporting, as such term is defined in Rules 13a-15(f) and 15d-15(f) under the Exchange Act, during the most recent fiscal quarter that have materially affected, or are reasonably likely to materially affect, our internal control over financial reporting.
PART II - OTHER INFORMATION
ITEM 1 – LEGAL PROCEEDINGS
We are not currently a party to any material legal proceedings, and we are not aware of any pending or threatened legal proceedings against us that we believe could have a material adverse effect on our business, operating results or financial condition.
ITEM 1A – RISK FACTORS
This section augments and updates certain risk factors disclosed under the heading “Risk Factors” contained in Part I, Item 1A of our 2023 Form 10-K. The following risk factors should be read together with the other risk factors disclosed in the Annual Report. In addition to the other information in this Quarterly Report on Form 10-Q, all the risk factors should be carefully considered in evaluating us and our common stock. Any of these risks, many of which are beyond our control, could materially and adversely affect our financial condition, results of operations or cash flows, or cause our actual results to differ materially from those projected in any forward-looking statements. We may also face other risks and uncertainties that are not presently known, are not currently believed to be material, or are not identified below because they are common to all businesses. Past financial performance may not be a reliable indicator of future performance, and historical trends should not be used to anticipate results or trends in future periods. There have been no material changes in our risk factors since such 2023 Form 10-K filing.
We may not be successful in managing the build-out of our manufacturing facilities and associated costs or satisfying manufacturing-related regulatory requirements.
We have been investing in our manufacturing capabilities and recently acquired several manufacturing facilities. In March 2024, we acquired the assets and associated lease of Lantheus Holdings, Inc.’s radiopharmaceutical manufacturing facility in Somerset, New Jersey. This site has three production suites that Perspective intends to utilize to supply drug product for the northeastern half of the United States. On July 15, 2024, August 2, 2024, and October 31, 2024, we purchased a building located in the Houston, Texas, metropolitan area for $4.7 million, a building in the Chicago, Illinois, metropolitan area for $5.0 million, and a building in the Los Angeles, California, metropolitan area for $11.0 million, respectively, which we intend to use for the manufacture of our program candidates upon completion of modifications and installation of equipment. The build-out of these facilities and related equipment purchases are complex and specialized and will involve substantial capital expenditures, and it could take longer, and cost more, than currently expected. Significant delays and/or cost overruns would result in higher expenditures and could be disruptive to operations, any of which could have a negative impact on our financial conditions or results of operations.
We also may not successfully realize the anticipated benefits from the capital expenditure at such facilities based on factors such as delays and uncertainties regarding development, regulatory approval and commercialization of our product candidates, as well as the potential to lose access to any leased facilities. Moreover, any production shortfall that impairs the supply of our product or other product candidates could negatively impact our ability to complete clinical trials, obtain regulatory approvals and commercialize our other product candidates. A product shortfall could have a material adverse effect on our business, financial condition and results of operations.
In addition, our planned operations, including our development, testing and future manufacturing activities, are subject to numerous environmental, health, and safety laws and regulations. These laws and regulations govern, among other things, the controlled use, handling, release and disposal of and the maintenance of a registry for, hazardous materials and biological materials, such as chemical solvents, carcinogenic compounds, mutagenic compounds and compounds that may have a toxic effect on reproduction and laboratory procedures. If we fail to comply with such laws and regulations, we could be subject to fines or other sanctions. Failure to successfully complete our build-outs and successfully operate our planned manufacturing facilities and satisfy manufacturing-related regulatory requirements could adversely affect the commercial viability of our product candidates and our business.
ITEM 2 – UNREGISTERED SALES OF EQUITY SECURITIES AND USE OF PROCEEDS
None.
ITEM 3 – DEFAULTS UPON SENIOR SECURITIES
None.
ITEM 4 - MINE SAFETY DISCLOSURES
Not applicable.
ITEM 5 – OTHER INFORMATION
Rule 10b5-1 Trading Arrangements
During the three months ended September 30, 2024, none of our directors or executive officers adopted, modified or terminated any “Rule 10b5-1 trading arrangement” or “non-Rule 10b5-1 trading arrangement,” as each term is defined in Item 408 of Regulation S-K.
ITEM 6 – EXHIBITS
(Except as otherwise indicated (a) all exhibits were previously filed, (b) all omitted exhibits are intentionally omitted, and (c) all documents referenced below were filed under SEC file number 001-33407.)
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Exhibits: |
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2.1 |
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Agreement and Plan of Merger, dated September 27, 2022, by and between Isoray, Inc., Isoray Acquisition Corp., Viewpoint Molecular Targeting, Inc., and Cameron Gray, incorporated by reference to Exhibit 2.1 of the Form 8-K filed on September 28, 2022. |
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2.2 |
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First Amendment to Agreement and Plan of Merger, dated October 21, 2022, between Isoray, Inc., Isoray Acquisition Corp., Viewpoint Molecular Targeting, Inc., and Cameron Gray, incorporated by reference to Exhibit 2.1 of the Form 8-K filed on October 24, 2022. |
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3.1 |
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Amended and Restated Certificate of Incorporation of Perspective Therapeutics, Inc. as of February 14, 2023, incorporated by reference to Exhibit 3.1 of the Form 8-K filed on February 16, 2023. |
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3.2 |
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Certificate of Amendment to the Amended and Restated Certificate of Incorporation of Perspective Therapeutics, Inc., effective June 14, 2024, incorporated by reference to Exhibit 3.1 of the Form 8-K filed on June 14, 2024. |
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3.3 |
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Amended and Restated Bylaws of Perspective Therapeutics, Inc. as of February 14, 2023, incorporated by reference to Exhibit 3.2 of the Form 8-K filed on February 16, 2023. |
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4.1 |
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Form of Pre-funded Warrant to Purchase Common Stock, incorporated by reference to Exhibit 4.1 of the Form 8-K filed on May 29, 2024. |
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10.1*! |
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Separation Agreement between Perspective Therapeutics, Inc. and Mark Austin, dated August 26, 2024. |
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10.2+# |
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Master Equipment and Services Agreement, dated as of September 18, 2024, by and between Perspective Therapeutics, Inc. and Comecer SpA, incorporated by reference to Exhibit 10.1 to the Form 8-K filed by the Company on September 20, 2024. |
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10.3+# |
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Form of Statement of Work Pursuant to Master Equipment and Services Agreement, dated as of September 18, 2024, by and between Perspective Therapeutics, Inc. and Comecer SpA, incorporated by reference to Exhibit 10.2 to the Form 8-K filed by the Company on September 20, 2024. |
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10.4 |
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Controlled Equity OfferingSM Sales Agreement, dated as of August 13, 2024, by and among Perspective Therapeutics, Inc., Cantor Fitzgerald & Co. and RBC Capital Markets, LLC, incorporated by reference to Exhibit 1.1 of the form 8-K filed on August 13, 2024. |
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31.1* |
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Certification of Principal Executive Officer Pursuant to Rules 13a-14(a) and 15d-14(a) under the Securities Exchange Act of 1934, as Adopted Pursuant to Section 302 of the Sarbanes-Oxley Act of 2002. |
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31.2* |
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Certification of Principal Financial Officer Pursuant to Rules 13a-14(a) and 15d-14(a) under the Securities Exchange Act of 1934, as Adopted Pursuant to Section 302 of the Sarbanes-Oxley Act of 2002. |
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32** |
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Certification of Principal Executive Officer and Principal Financial Officer Pursuant to 18 U.S.C. Section 1350, as Adopted Pursuant to Section 906 of the Sarbanes-Oxley Act of 2002. |
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101.INS* |
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Inline XBRL Instance Document |
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101.SCH* |
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Inline XBRL Taxonomy Extension Schema with Embedded Linkbase Documents |
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104 |
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Cover Page Interactive Data File (formatted as Inline XBRL and contained in Exhibit 101) |
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* |
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Filed herewith |
** |
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Furnished herewith |
+ |
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Certain schedules and exhibits have been omitted pursuant to Item 601(a)(5) of Regulation S-K. The Company will furnish supplementally a copy of any omitted schedule or exhibit to the Securities and Exchange Commission upon request. The Company may request confidential treatment pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended, for any schedules or exhibits so furnished. |
# |
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Certain portions of this exhibit (indicated by asterisks) have been omitted pursuant to Item 601(b)(10)(iv) of Regulation S-K. |
! |
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Denotes Management Contract or Compensatory Plan or Arrangement |
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned thereunto duly authorized.
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Dated: November 12, 2024 |
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PERSPECTIVE THERAPEUTICS, INC., a Delaware corporation |
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/s/ Johan (Thijs) Spoor |
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Johan (Thijs) Spoor |
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Chief Executive Officer (Principal Executive Officer) |
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/s/ Jonathan Hunt |
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Jonathan Hunt |
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Chief Financial Officer and Chief Accounting Officer (Principal Financial Officer and Principal Accounting Officer) |
Exhibit 10.1
CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY “[***]” HAS BEEN OMITTED BECAUSE IT IS BOTH (I) NOT MATERIAL AND (II) IS THE TYPE THAT THE REGISTRANT TREATS AS PRIVATE OR CONFIDENTIAL.
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Phone: |
(206) 676-0900 |
2401 Elliott Ave., Suite 320 |
Toll Free: |
(877) 447-6729 |
Seattle, WA 98121 |
https://perspectivetherapeutics.com |
August 19, 2024
Mark Austin
[***]
Re: Terms of Separation
Dear Mark:
This letter confirms the agreement (“Agreement”) between you and Perspective Therapeutics, Inc. (the “Company”) concerning the terms of your separation and offers you the separation compensation we discussed in exchange for a general release of claims and covenant not to sue.
1.Cessation of Employment: Your employment as the Company’s Vice President of Finance, Corporate Controller and Corporate Secretary and as the Company’s co-principal financial officer and principal accounting officer ceased effective August 16, 2024, (the “Officer Separation Date”). As of the Officer Separation Date, you are deemed to no longer serve as an officer or director (as applicable) of the Company and any of its subsidiaries and affiliates. Following the Officer Separation Date, you will remain a full-time employee of the Company in the role of Strategic Advisor, providing transition services from the Officer Separation Date through August 30, 2024 (such period, the “Transition Period”). During the Transition Period, you will provide, on a best efforts basis, transition assistance and advice as set forth on Exhibit A and as reasonably requested from time to time by the Company’s Chief Executive Officer, Chief Financial Officer or Board of Directors. Your employment with the Company will cease effective as of 11:59pm PDT on the final day of the Transition Period (the “Separation Date”).
2.Salary and Expense Reimbursements: No later than the Company’s first regular payroll date following the Separation Date, we will provide you with one or more final paychecks for all wages, accrued but unused vacation and any similar payments due you from the Company as of the Separation Date. By signing below, you acknowledge that the Company does not owe you any other amounts (other than as provided for in Section 3 herein). Please promptly submit for reimbursement all final outstanding expenses, if any.
3.Separation Compensation: Subject to, and wholly contingent upon, you (i) executing and delivering this Agreement and thereby agreeing to the general release and waiver of claims and covenant not to sue set forth below and your other promises herein, on both the Officer Separation Date and the Separation Date, and such general release and waiver of claims becoming irrevocable,
and (ii) complying with the terms of this Agreement, the Company agrees to provide you with the following (collectively, the “Separation Compensation”):
a.Severance: The Company agrees to pay you by the next payroll processing date following the Effective Date (as defined below) of this Agreement, a lump sum payment in the gross amount of $138,360.75, less applicable state and federal payroll deductions, which equals approximately six (6) months of your base salary.
b.COBRA: A lump sum payment in the amount of $7,686.54, minus required withholdings, which is intended to help you pay for health insurance premiums for a period of six (6) months. This will be reported to the IRS as wages on your Form W-2.
By signing below, you acknowledge that you are receiving the Separation Compensation outlined in this section in consideration for waiving your rights to claims referred to in this Agreement and that you would not otherwise be entitled to the Separation Compensation.
4.Post-Employment Obligations: You hereby acknowledge and agree that: (a) you will continue to be bound by the Company’s form of Confidentiality and Non-Disclosure Agreement, which is attached hereto as Exhibit B (the “Confidentiality Agreement”) and which is hereby incorporated by reference into this Agreement; (b) as a result of your employment with the Company, you have had access to the Company’s proprietary and/or confidential information, observations and data which may constitute trade secrets, and you agree not to disclose to any person or entity or use for your own (or any other person’s or entity’s ) purposes any confidential information or any confidential or proprietary information of other persons or entities in the possession of the Company and its affiliates (“Third Party Information”), without the prior written consent of the Company unless and to the extent that such confidential information or Third Party Information becomes generally known to and available for use by the public other than as a result of your direct or indirect acts or omissions; and (c) you must, and by your signature below confirm that you shall, deliver to the Company or its designated representative, no later than the Separation Date, all documents and data of any nature containing or pertaining to such information, and not take with you, or otherwise retain in any respect, any such documents or data or any reproduction thereof. For the avoidance of doubt, such proprietary and/or confidential information includes, but is not limited to, all information and materials concerning the business and affairs of the Company and its subsidiaries and predecessors, and information belonging to the Company or its clients, staff, or service providers, including office keys and Company equipment, credit cards, documents, policy or practice manuals, files, written materials, memoranda, electronic information, computer software or hardware, computer and other passwords, computer disks, records of the Company or its past, present or prospective clients, vendors and other third parties, and copies of such records, correspondence, memoranda, notes, plans, reports and other books or manuals issued by the Company. To the extent an electronic copy exists of such materials, you must permanently delete such electronic copy/copies on or before the Separation Date (following transmittal to the Company of such documents as set forth above). You hereby acknowledge that if you do not return any hard-copy paper documents and/or electronic media within the time set forth above, you are affirming and representing to the best of your knowledge that you have no such materials in your possession.
5.Inventions and Intellectual Property Rights: You acknowledge that all discoveries, concepts, ideas, inventions, innovations, improvements, developments, methods, designs, analyses, drawings, reports, patent applications and copyrightable work (whether or not including any Confidential Information) and all registrations or applications related thereto, all other proprietary
information and all similar or related information (whether or not patentable) that relate to the Company’s or any of its subsidiaries’ actual or anticipated business, research and development or existing or future products or services and that you have conceived, developed or made (whether alone or jointly with others) while employed by the Company or any of its subsidiaries or predecessors, whether before or after the date of this Agreement (“Work Product”), belong to the Company. You agree to disclose such Work Product to the Company and, at the Company’s expense, perform all actions reasonably requested by the Company (whether during or after your employment) to establish and confirm such ownership (including assignments, consents, powers of attorney and other instruments). You acknowledge that all Work Product shall be deemed to constitute “works made for hire” under the U.S. Copyright Act of 1976, as amended.
6.Stock Options: Pursuant to your Stock Option Agreement(s) with the Company and the Company's equity incentive plans (together, the “Stock Option Agreements”), you were granted options to purchase shares of the Company's common stock (the “Option”). Your rights concerning the Options are summarized in the equity report which is attached hereto as Exhibit C.
7.General Release and Waiver of Claims:
a.In consideration of and subject to the performance by the Company of its obligations under this Agreement, you acknowledge and agree that the payments and promises set forth in this Agreement are in full satisfaction of all accrued salary, vacation, bonus and commission pay, profit‑sharing, stock, stock options or other ownership interest in the Company, termination benefits or other compensation to which you may be entitled by virtue of your employment with the Company or your separation from the Company. To the fullest extent permitted by law, you hereby release and waive any other claims you may have against the Company, all of its affiliates (including, but not limited, to, Isoray Medical, Inc. and Viewpoint Molecular Targeting, Inc.) and all of the Company’s present and former owners, representatives, agents, officers, shareholders, partners, members, employees, directors, attorneys, subscribers, subsidiaries, successors and assigns, and their respective affiliates (collectively, the “Releasees”), whether known or not known, including, without limitation, claims under any employment laws, including, but not limited to, claims of unlawful discharge, breach of contract, breach of the covenant of good faith and fair dealing, fraud, violation of public policy, defamation, physical injury, emotional distress, claims for additional compensation or benefits arising out of your employment or your separation of employment, claims under Title VII of the 1964 Civil Rights Act, as amended, the Washington Law Against Discrimination and any other laws and/or regulations relating to employment or employment discrimination, including, without limitation, claims based on age or under the Age Discrimination in Employment Act or Older Workers Benefit Protection Act, and/or claims based on disability or under the Americans with Disabilities Act.
b.You hereby acknowledge that you are aware of the principle that a general release does not extend to claims that the releasor does not know or suspect to exist in his or her favor at the time of executing the release, which, if known by him or her, must have materially affected his or her settlement with the releasee. With knowledge of this principle, you hereby agree to expressly waive any rights you may have to that effect.
c.You and the Company do not intend to release claims that you may not release as a matter of law, including but not limited to claims for indemnity, and any claims for enforcement of this Agreement. To the fullest extent permitted by law, any dispute regarding the
scope of this general release shall be determined by an arbitrator under the procedures set forth in the arbitration clause below.
8.Covenant Not to Sue: To the fullest extent permitted by law, at no time subsequent to the execution of this Agreement will you pursue, or cause or knowingly permit the prosecution, in any state, federal or foreign court, or before any local, state, federal or foreign administrative agency, or any other tribunal, of any charge, claim or action of any kind, nature and character whatsoever, known or unknown, which you may now have, have ever had, or may in the future have against Releasees, which is based in whole or in part on any matter released by this Agreement. Nothing in this section shall prohibit or impair you or the Company from complying with all applicable laws, nor shall this Agreement be construed to obligate either party to commit (or aid or abet in the commission of) any unlawful act.
9.Cooperation: You agree to reasonably cooperate with the Company in any internal investigation, any administrative, regulatory, or judicial proceeding or any dispute with a third party. You understand and agree that you cooperation may include, but not be limited to, making yourself available to the Company for interviews and factual investigations; appearing at the Company’s request to give testimony without requiring service of a subpoena or other legal process; volunteering to the Company pertinent information; and turning over to the Company all relevant documents which are or may come into your possession.
a.You understand that nothing in this Agreement, including the General Release and Waiver of Claims, Covenant Not to Sue, Non-Disparagement and Confidentiality sections contained herein, limits, impedes or restricts: (a) your ability to file a charge or complaint with the Equal Employment Opportunity Commission (the “EEOC”), the National Labor Relations Board (the “NLRB”), the Occupational Safety and Health Administration, the Securities and Exchange Commission or any other federal, state or local government agency or commission (“Government Agencies”); or (b) if you are a non-supervisory (as defined under the National Labor Relations Act (the “NLRA”)) Company employee, you from exercising your protected rights under Section 7 of the NLRA, including your right to file an unfair labor practice charge with the NLRB and/or assist other current or former Company employees in doing so. You further understand that this Agreement does not limit your ability to communicate with any Government Agencies or otherwise participate and/or assist in any investigation or proceeding that may be conducted by any Government Agency, including providing documents (including this Agreement) or other information, without notice to the Company. This Agreement does not limit your right to receive an award for information provided to any Government Agencies or prohibit you from providing truthful information in response to a subpoena or other legal process.
b.Further, nothing in the Non-Disparagement and Confidentiality sections, or otherwise in this Agreement, shall prohibit you from discussing or disclosing workplace or work-related conduct (including conduct at the workplace, at work-related events coordinated by or through the Company, between employees, or between the Company and an employee, whether on or off the employment premises) that you reasonably believed, under Washington state, federal, or common law, to be illegal discrimination, illegal harassment, illegal retaliation, a wage and hour violation, sexual assault, or that is recognized as against a clear mandate of public policy.
11.Non-Disparagement: Subject to the Protected Rights section above, and otherwise to the fullest extent permitted by applicable law, you agree that you will not, directly or indirectly, make any disparaging oral or written statements that are disloyal or maliciously untrue (and specifically, made with knowledge of their falsity or with reckless disregard for the truth or falsity of the statements) regarding the Company and/or its products, services, directors, officers, employees and affiliated entities, including, but not limited to, any statement posted on social media (including online company review sites) or otherwise on the Internet, whether or not made anonymously or with attribution. Additionally, you acknowledge that all requests for employment references will be directed to the Company’s Human Resources department. The Company will provide a neutral reference confirming only the dates of employment and positions held unless otherwise required by law.
12.Arbitration: Except for any claim for injunctive relief arising out of a breach of a party’s obligations to protect the other’s proprietary information, the parties agree to arbitrate, in Seattle, Washington through JAMS, any and all disputes or claims arising out of or related to the validity, enforceability, interpretation, performance or breach of this Agreement, whether sounding in tort, contract, statutory violation or otherwise, or involving the construction or application or any of the terms, provisions, or conditions of this Agreement. Any arbitration may be initiated by a written demand to the other party. The arbitrator’s decision shall be final, binding, and conclusive. The parties further agree that this Agreement is intended to be strictly construed to provide for arbitration as the sole and exclusive means for resolution of all disputes hereunder to the fullest extent permitted by law. The parties expressly waive any entitlement to have such controversies decided by a court or a jury.
13.Consequences of Breach: In the event you breach or threaten to breach the terms and provisions of this Agreement, the Company shall be entitled, if it so elects, to institute and prosecute any action or proceedings either in law or equity, for such relief as it deems appropriate, including without limiting the generality of the foregoing, proceedings to enforce the specific performance thereof by you or to enjoin you from engaging in conduct prohibited by this Agreement. You hereby waive the requirement that the Company post a bond or undertaking to obtain an injunction pursuant to this provision.
14.Attorneys’ Fees: If any action is brought to enforce the terms of this Agreement, the prevailing party will be entitled to recover its reasonable attorneys’ fees, costs and expenses from the other party, in addition to any other relief to which the prevailing party may be entitled.
15.Confidentiality: Subject to the Protected Rights section above, and otherwise to the fullest extent permitted by applicable law, the contents, terms and conditions of this Agreement must be kept confidential by you and may not be disclosed except to your immediate family, accountant or attorneys or pursuant to subpoena or court order.
16.No Admission of Liability: This Agreement is not and shall not be construed or contended by you to be an admission or evidence of any wrongdoing or liability on the part of Releasees, their representatives, heirs, executors, attorneys, agents, partners, officers, shareholders, directors, employees, subsidiaries, affiliates, divisions, successors or assigns. This Agreement shall be afforded the maximum protection allowable under Washington Rules of Evidence 408 and/or any other state or federal provisions of similar effect.
17.Complete and Voluntary Agreement: This Agreement, together with Exhibit A, Exhibit B and Exhibit C hereto and the Stock Option Agreements (if any), constitute the entire agreement between you and Releasees with respect to the subject matter hereof and supersedes all prior negotiations and agreements, whether written or oral, relating to such subject matter. You acknowledge that neither Releasees nor their agents or attorneys have made any promise, representation or warranty whatsoever, either express or implied, written or oral, which is not contained in this Agreement for the purpose of inducing you to execute the Agreement, and you acknowledge that you have executed this Agreement in reliance only upon such promises, representations and warranties as are contained herein, and that you are executing this Agreement voluntarily, free of duress or coercion.
18.Severability: The provisions of this Agreement are severable, and if any part of it is found to be invalid or unenforceable, including, without limitation, any part of the General Release, Covenant Not to Sue, Non-Disparagement and/or Confidentiality sections above, the other parts shall remain fully valid and enforceable. Specifically, should a court, arbitrator, or government agency conclude that a particular claim may not be released as a matter of law, it is the intention of the parties that the general release, the waiver of unknown claims and the covenant not to sue above shall otherwise remain effective to release any and all other claims.
19.Modification; Counterparts; Electronic/PDF Signatures: It is expressly agreed that this Agreement may not be altered, amended, modified, or otherwise changed in any respect except by another written agreement that specifically refers to this Agreement, executed by authorized representatives of each of the parties to this Agreement. This Agreement may be executed in any number of counterparts, each of which shall constitute an original and all of which together shall constitute one and the same instrument. Execution of an electronic or PDF copy shall have the same force and effect as execution of an original, and a copy of a signature will be admissible in any legal proceedings as if an original.
20.Review of Separation Agreement; Expiration of Offer: You understand that you may take up to five (5) days to consider this Agreement (the “Consideration Period”). The offer set forth in this Agreement, if not accepted by you before the end of the Consideration Period, will automatically expire. By signing below, you affirm that you were advised to consult with an attorney prior to signing this Agreement and that any modifications to this Agreement, whether or not material, will not restart the Consideration Period.
21.Effective Date: You will have seven (7) days after execution of this Agreement (the “Revocation Period”) to revoke the release contained herein, and such release shall not become effective or enforceable until such Revocation Period has expired. The Company’s promises under this Agreement, including but not limited to its obligation to provide Separation Compensation, will arise only after this time.
22.Governing Law: This Agreement shall be governed by and construed in accordance with the laws of the State of Washington.
YOU MUST EXECUTE THIS RELEASE BY 11:59pm PDT ON AUGUST 26, 2024, and again within five (5) days after the separation Date IN ORDER TO BE ELIGIBLE TO RECEIVE THE SEPARATION COMPENSATION.
If you agree to abide by the terms outlined in this Agreement, please sign and return it to Sarah Wille (HR) at [***]. I wish you the best in your future endeavors.
Sincerely,
Perspective Therapeutics, Inc.
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By: |
/s/ Thijs Spoor |
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Thijs Spoor, Chief Executive Officer |
READ, UNDERSTOOD AND AGREED
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/s/ Mark Austin |
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Date: |
08/26/2024 |
Mark Austin |
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RE-AFFIRMED
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/s/ Mark Austin |
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Date: |
09/03/2024 |
Mark Austin |
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EXHIBIT A
TRANSITION SERVICES
[Omitted.]
EXHIBIT B
CONFIDENTIALITY AND NON-DISCLOSURE AGREEMENT
This Confidentiality and Non-Disclosure Agreement (the “Agreement”), entered into and effective as of [ ], 2024 (the “Effective Date”), by and between PERSPECTIVE THERAPEUTICS, INC., a Delaware corporation (together with its Affiliates and subsidiaries (the “Disclosing Party”), and Mark Austin (the “Receiving Party”). The Disclosing Party and the Receiving Party may each hereinafter be referred to individually as a “Party” and collectively as the “Parties.”
RECITALS
WHEREAS, in conjunction with Receiving Party’s employment with the Disclosing Party (the “Purpose”), the Disclosing Party may wish to disclose certain Confidential Information (as defined hereunder) to the Receiving Party.
NOW THEREFORE, as a material inducement for the disclosure of Confidential Information and in consideration of the covenants and conditions set forth herein and for other good and valuable consideration, the receipt and sufficiency of which are hereby acknowledged, the Parties hereby agree as follows:
ARTICLE I. DEFINITIONS
For purposes of this Agreement, the following terms will have the meanings ascribed to them below, unless otherwise clearly required by the context in which such term is used:
1.1“Affiliate” means, with respect to either Party, any other corporation or business entity that directly, or indirectly through one or more intermediaries, controls, is controlled by or is under common control with such Party for as long as such control exists. For purposes of this definition, the term “control” means (i) the direct or indirect ownership of more than fifty percent (50%) of the securities or other ownership interests representing the equity voting stock or general partnership or membership interest of such entity, or (ii) the power to direct or cause the direction of the management or policies of such entity, whether through the ownership of voting securities, by contract, or otherwise.
1.2“Disclosing Party” has the meaning set forth in the introductory paragraph of this Agreement.
1.3“Purpose” has the meaning set forth in the Recitals section of this Agreement.
1.4“Receiving Party” has the meaning set forth in the introductory paragraph of this Agreement.
ARTICLE II. CONFIDENTIAL INFORMATION
2.1 Confidential Information. As used in this Agreement, the term “Confidential Information” means any and all data, information, documents, records and/or materials including, but not limited to, that which relates to business plans, strategic plans or business methods that derive economic value from not being generally known to other persons or easily ascertainable by other persons, business policies, research, product plans, product pricing or product strategy, services, service pricing or service strategy, actual or proposed alliance partners, actual or proposed vendors, vendor offerings and pricing, actual or proposed customers, customer usage and customer purchasing potential, employee and consulting relationship information, actual or proposed markets, sales and marketing materials, plans and methods, specifications, shop-practices, software, developments, inventions (whether or not patented), product names or marks, trade secrets, technologies, discoveries, and any other intellectual property (whether or not registered), processes, designs, drawings, engineering, hardware configuration information or finance, accounting or financial plans and forecasts, compilations, formulas, devices, methods, prototypes, techniques, procedures, protocols, programs, records, and databases, that are disclosed or delivered by or on behalf of the Disclosing Party to the Receiving Party in connection with the Purpose, regardless of whether disclosed in writing, orally, visually, or in tangible, electronic, or any other form or manner. Each Party’s Confidential Information shall, if disclosed in writing, be marked “CONFIDENTIAL” and, if disclosed orally shall, within thirty (30) days of disclosure, be reduced to writing, marked “CONFIDENTIAL” and delivered to the Receiving Party; provided, however, any information which by its nature is confidential and would be judged so under a reasonable standard, or is disclosed, or provided, under circumstances reasonably indicating it is confidential, shall be considered Confidential Information regardless of whether it is marked as “CONFIDENTIAL” or reduced to writing and marked as “CONFIDENTIAL.”
2.2 Exclusions. The term “Confidential Information” excludes information that:
2.2.1 is or becomes publicly available through actions of persons or entities other than the Receiving Party or its Representatives (as hereinafter defined);
2.2.2 is obtained by the Receiving Party from a third party who is under no obligation of confidentiality with respect thereto and who is authorized to disclose such information on a non-confidential basis to the Receiving Party;
2.2.3 was in the possession of the Receiving Party prior to disclosure by the Disclosing Party, and was not acquired, directly or indirectly, from the Disclosing Party, as evidenced by the records of the Receiving Party; or
2.2.4 is independently developed by the Receiving Party without any use of the Disclosing Party’s Confidential Information, as evidenced by the records of the Receiving Party.
ARTICLE III. OBLIGATIONS OF THE RECEIVING PARTY
3.1 Maintenance of Confidentiality. The Receiving Party shall keep the Disclosing Party’s Confidential Information confidential, and in furtherance thereof:
3.1.1 The Receiving Party shall ensure that neither the Receiving Party nor its Affiliates, and their officers, directors, partners, employees, agents, or other representatives (collectively “Representatives”) disclose the Disclosing Party’s Confidential Information, in any manner whatsoever, in whole or in part, except to the extent expressly permitted by this Agreement, without the prior written consent of the Disclosing Party.
3.1.2 In handling the Confidential Information of the Disclosing Party, the Receiving Party must use the same care and discretion as it employs with its own confidential information (but in no event less than reasonable care and discretion) to prevent disclosure, publication, use, or dissemination of the Confidential Information of the Disclosing Party, except to the extent expressly permitted under this Agreement.
3.1.3 Without the prior written consent of the Disclosing Party, which consent shall not be unreasonably withheld, conditioned or delayed, the Receiving Party shall not, and shall direct its Representatives not to disclose any Confidential Information to any potential investors, co-bidders, consultants, financial advisors or other advisors, or banks or other debt or equity financing sources (collectively, the “Financing Sources”), or otherwise discuss Confidential Information to any such Financing Sources; provided that if Disclosing Party should determine to provide such written consent in its sole and absolute discretion, Receiving Party agrees to promptly disclose to the Disclosing Party in writing all Financing Sources with whom Receiving Party proposes to share such Confidential Information. Receiving Party represents and covenants that it does not have (and will not enter into) any agreement or arrangement with any potential Financing Sources which may reasonably be expected to limit such financing source from acting as a Financing Source with the Disclosing Party.
3.1.4 In the event that the Receiving Party is required to disclose the Disclosing Party’s Confidential Information under operation of applicable law, regulation, or order of a court or governmental administrative body having competent jurisdiction, the Receiving Party shall, to the extent practicable, provide the Disclosing Party reasonable notice of such potential disclosure so that that the Disclosing Party may seek a protective order or other appropriate protection or legal relief to prevent or limit such disclosure. If, in the absence of, or pursuant to the terms of, such protection or legal relief, the Receiving Party is nonetheless required by applicable law, regulation, or order of a court or governmental administrative body having competent jurisdiction to disclose any portion of the Disclosing Party’s Confidential Information, the disclosure shall be limited to only that portion of the Disclosing Party’s Confidential Information that is required to be disclosed.
3.1.5 The Receiving Party and its Representatives may use the Disclosing Party’s Confidential Information only in connection with the Purpose and shall not use the Disclosing Party’s Confidential Information for any other purpose.
3.1.6 The Disclosing Party’s Confidential Information shall remain the property of the Disclosing Party, and nothing in this Agreement grants the Receiving Party or its Representatives any license, assignment, right, title, or interest to any invention, work of authorship, product, material, patent, patent application or other intellectual property, or other subject matter pertaining to the Disclosing Party’s Confidential Information. The disclosure of Confidential Information shall not result in any obligation by the Disclosing Party to grant the Receiving Party any rights in and to such Confidential Information. Nothing herein grants or provides the Receiving Party the right to file patent applications on or arising from the Disclosing Party’s Confidential Information.
3.1.7 The Receiving Party shall promptly notify the other upon discovery of any loss or unauthorized disclosure of the Confidential Information of the Disclosing Party.
3.2 The Receiving Party hereby acknowledges that it understands that: (i) the Confidential Information provided by the Disclosing Party may contain or constitute material non-public information concerning the Disclosing Party or its Affiliates; and (ii) trading in the Disclosing Party’s securities while in possession of material nonpublic information or communicating that information to any other person who trades in such securities could subject the Receiving Party (or its Representatives) to liability under U.S. federal and state securities laws, and the rules and regulations promulgated thereunder, including Section 10(b) of the Securities Exchange Act of 1934, as amended, and Rule 10b-5 promulgated thereunder.
3.2Receiving Party’s Representatives. The Receiving Party may disclose the Disclosing Party’s Confidential Information only to another Party or those Representatives of the Receiving Party who have been informed of this Agreement, who need to know such Confidential Information to assist the Receiving Party in evaluating the Purpose, and who are subject to obligations of confidentiality and non-use at least as strict as the Receiving Party’s obligations under this Agreement. The Receiving Party shall not disclose the Disclosing Party’s Confidential Information to any other person or entity. The Receiving Party shall ensure that its Representatives comply with the non-use and confidentiality obligations and restrictions set forth in this Agreement, and the Receiving Party shall be fully liable for any breach of such obligations and restrictions by its Representatives.
3.3Return and Destruction of Confidential Information. Within ten (10) business days after the Disclosing Party’s request:
3.3.1The Receiving Party shall deliver to the Disclosing Party all originals of the Disclosing Party’s Confidential Information provided to the Receiving Party or its Representatives.
3.3.2The Receiving Party shall destroy or delete any duplicates, copies, abstracts, notes, memoranda, summaries, evaluations, studies, projections, analysis, extrapolations, or the like (in any form) generated by the Receiving Party or its Representatives that contain, incorporate or are based on any Confidential Information of the Disclosing Party. If requested by the Disclosing Party, the Receiving Party will provide the Disclosing Party a written confirmation, signed by an officer or other authorized Representative of the Receiving Party, that all such materials have been destroyed or deleted, as provided in this Agreement.
3.3.3Notwithstanding the foregoing, the Receiving Party is not required to destroy any computer files containing the Disclosing Party’s Confidential Information that are created during automatic computer system backup, provided that such files are stored securely by the Receiving Party. Further, the Receiving Party’s records management or legal department may retain one copy of the Disclosing Party’s Confidential Information for archival purposes only to verify compliance with this Agreement, and for no other purpose.
ARTICLE IV. ACCURACY OF INFORMATION
4.1 Representations and Warranties. Neither the Disclosing Party nor any of its Representatives has made or makes any representation or warranty, express or implied, as to the accuracy or completeness of the Disclosing Party’s Confidential Information. Neither the Disclosing Party nor its Representatives will have any liability to the Receiving Party or to any of its Representatives resulting from the provision or use of the Disclosing Party’s Confidential Information.
ARTICLE V. INJUNCTIVE RELIEF
5.1 Breach by the Receiving Party. In the event of any breach of this Agreement, the Disclosing Party may be irreparably and immediately harmed and may not be made whole by monetary damages. Accordingly, in addition to any other remedy to which it may be entitled at law or in equity, the Disclosing Party will be entitled to seek immediate injunctive relief (without the posting of any bond and without proof of actual damages) as well as any other remedies available at law or in equity to prevent breaches or threatened breaches of this Agreement and/or to compel specific performance of this Agreement.
ARTICLE VI. MISCELLANEOUS
6.1 Waiver of Breach. No failure or delay by the Disclosing Party in exercising any right, power, or privilege under this Agreement will operate as a waiver thereof, nor will any single or partial exercise of any such right, power, or privilege preclude any other or further exercise thereof.
6.2 Amendment. This Agreement may be modified or amended only by a separate writing signed by the Parties, expressly so modifying or amending such Agreement.
6.3 Severability. If one or more provisions of this Agreement will be held unenforceable, invalid, or illegal in any respect, such unenforceability, invalidity, or illegality will not affect any other provision of this Agreement, which will be construed as if such unenforceable, invalid or illegal provision had never been a part hereof.
6.4 Governing Law; Jurisdiction; Venue. This Agreement (including any claim or controversy arising out of or relating to this Agreement) shall be governed by the laws of the State of Delaware without regard to conflict of law principles that would result in the application of any law other than the laws of the State of Delaware. The exclusive venue and jurisdiction for any
disputes shall be the State of Delaware and the Parties each hereby waive any claims of inconvenient forum with respect thereto.
6.5 Nondisclosure. Except as required by law or regulation, neither a Party nor its Representatives will disclose to any person that discussions or negotiations are taking place concerning the Purpose, including the status thereof, without the prior written consent of the other Party. Notwithstanding the foregoing, a Party may disclose the existence of this Agreement to prospective investors or partners, provided that any such party to whom disclosure is permitted has agreed to keep such information confidential.
6.6 Non-Binding Negotiations. Unless and until a separate, definitive written agreement between the Parties with respect to the Purpose has been fully executed by, and delivered to, all parties thereto, no Party will be under any legal obligation of any kind whatsoever with respect to the Purpose by virtue of this or any other written or oral expression by it or by any of its Representatives except, in the case of this Agreement, for the matters specifically agreed to in this Agreement. This Agreement shall not place any Party under any obligation to enter into any further agreement with the other Parties.
6.7 Entire Agreement. This Agreement represents the full and complete agreement of the Parties hereto with respect to the disclosure of the Confidential Information relating to the Purpose and supersedes and cancels all prior communications, understandings, and agreements between the Parties with respect to the disclosure of information pertaining to the Purpose, whether oral, express, or implied.
6.8 Term. This Agreement is effective as of the Effective Date and will continue for a period of one (1) year after the Effective Date, unless terminated early on thirty (30) days’ written notice by any Party. A Party’s obligations of confidentiality and restrictions on use of the Confidential Information disclosed by another Party will survive the expiration or termination of this Agreement for a period of five (5) years from the date of such expiration or termination.
6.9 Authority to Enter Agreement. This Agreement has been duly authorized, and upon execution by all Parties, is a legal, valid and binding obligation of each Party, enforceable in accordance with its terms.
6.10 Use of a Party’s Name. No Party shall use the name of another Party or its employees without the express written consent of an authorized representative of the other Party.
6.11 Notice. All notices, requests, consents, claims, demands, waivers and other communications under this Agreement (each, a “Notice”) must be in writing and addressed to the other Party at its address set forth below (or to such other address that the receiving Party may designate from time to time in accordance with this section). Notices shall be deemed properly given if delivered to the below-referenced locations or such other location as a Party may specify pursuant to a notice under this Section 6.11 by (a) certified mail, return receipt requested, (b) nationally-recognized courier services, or (c) email (at the email address set forth below or at such other email address as a Party may specify pursuant to a notice under this Section 6.11) followed by a confirmation of receipt. Except for formal notices (i.e., notices of termination, notice of
material breach, or similar notices), which must be provided under (a) or (b), day-to-day communications can be conducted via email under (c).
To Disclosing Party, if by mail or courier:
Perspective Therapeutics, Inc.
2401 Elliott Avenue, Suite 320
Seattle, Washington 98121
[***]
To Receiving Party, if by mail or courier:
Mark Austin
[***]
or other addresses as may be given from time to time under the terms of this notice provision.
6.12 Electronic Copies of Signatures and Original Agreement. Facsimiles and scanned images of original signatures shall be considered as valid and binding as original signatures, and as such, a facsimile or scanned image of an original signature delivered by the executing Party to the other Parties shall create a valid and binding obligation of the Party executing (or on whose behalf such signature is executed) with the same force and effect as if such facsimile or scanned signature was an original signature. In addition, images of an original of the fully executed Agreement (which original Agreement may have original signatures, facsimile or scanned images of original signatures, or combinations thereof as provided herein) may be stored electronically. The Parties intend that electronic copies or images of an original Agreement, which are reproduced from the electronically stored image of the original Agreement and which accurately reflect the original Agreement, shall be valid as an original.
6.13 Assignment. This Agreement may not be assigned or otherwise transferred by a Party without the consent of the other Parties; provided however, that any Party may, without such consent, assign its rights and obligations under this Agreement to any Affiliate or, in connection with a merger, consolidation or sale of substantially all of the business of the Party to which this Agreement relates.
6.14 Counterparts. This Agreement may be executed in counterparts, each of which shall be deemed an original, but all of which together shall constitute one and the same instrument.
[Signature Page Follows]
IN WITNESS WHEREOF, the Parties have executed this Agreement as of the Effective Date.
DISCLOSING PARTY:
PERSPECTIVE THERAPEUTICS, INC.
By:
Name:
Title:
RECEIVING PARTY:
Mark Austin
By:
Name:
Title:
EXHIBIT C
[Omitted.]
Exhibit 31.1
CERTIFICATION PURSUANT TO RULES 13a-14(a) AND 15d-14(a)
UNDER THE SECURITIES EXCHANGE ACT OF 1934,
AS ADOPTED PURSUANT TO SECTION 302 OF THE SARBANES-OXLEY ACT OF 2002
I, Johan (Thijs) Spoor, certify that:
1.I have reviewed this quarterly report on Form 10-Q of Perspective Therapeutics, Inc.;
2.Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report;
3.Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this report;
4.The registrant's other certifying officer(s) and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15d-15(f)) for the registrant and have:
a)Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us by others within those entities, particularly during the period in which this report is being prepared;
b)Designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles;
c)Evaluated the effectiveness of the registrant's disclosure controls and procedures and presented in this report our conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and
d)Disclosed in this report any change in the registrant's internal control over financial reporting that occurred during the registrant's most recent fiscal quarter (the registrant's fourth fiscal quarter in the case of an annual report) that has materially affected, or is reasonably likely to materially affect, the registrant's internal control over financial reporting; and
5.The registrant's other certifying officer(s) and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the registrant's auditors and the audit committee of the registrant's board of directors (or persons performing the equivalent functions):
a)All significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely affect the registrant's ability to record, process, summarize and report financial information; and
b)Any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant's internal control over financial reporting.
Date: November 12, 2024
|
|
|
/s/ Johan (Thijs) Spoor |
|
Johan (Thijs) Spoor |
|
Chief Executive Officer |
|
(Principal Executive Officer) |
Exhibit 31.2
CERTIFICATION PURSUANT TO RULES 13a-14(a) AND 15d-14(a)
UNDER THE SECURITIES EXCHANGE ACT OF 1934,
AS ADOPTED PURSUANT TO SECTION 302 OF THE SARBANES-OXLEY ACT OF 2002
I, Jonathan Hunt, certify that:
1.I have reviewed this quarterly report on Form 10-Q of Perspective Therapeutics, Inc.;
2.Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report;
3.Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this report;
4.The registrant's other certifying officer(s) and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15d-15(f)) for the registrant and have:
a)Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us by others within those entities, particularly during the period in which this report is being prepared;
b)Designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles;
c)Evaluated the effectiveness of the registrant's disclosure controls and procedures and presented in this report our conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and
d)Disclosed in this report any change in the registrant's internal control over financial reporting that occurred during the registrant's most recent fiscal quarter (the registrant's fourth fiscal quarter in the case of an annual report) that has materially affected, or is reasonably likely to materially affect, the registrant's internal control over financial reporting; and
5.The registrant's other certifying officer(s) and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the registrant's auditors and the audit committee of the registrant's board of directors (or persons performing the equivalent functions):
a)All significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely affect the registrant's ability to record, process, summarize and report financial information; and
b)Any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant's internal control over financial reporting.
Date: November 12, 2024
|
|
|
/s/ Jonathan Hunt |
|
Jonathan Hunt |
|
Chief Financial Officer |
|
(Principal Financial Officer and Principal Accounting Officer) |
Exhibit 32
CERTIFICATION PURSUANT TO
18 U.S.C. SECTION 1350, AS ADOPTED PURSUANT TO
SECTION 906 OF THE SARBANES-OXLEY ACT OF 2002
In connection with the Quarterly Report on Form 10-Q of Perspective Therapeutics, Inc. (the “Company”) for the quarter ended September 30, 2024, as filed with the Securities and Exchange Commission on the date hereof (the “Report”), we, Johan (Thijs) Spoor, Chief Executive Officer of the Company, and Jonathan Hunt, Chief Financial Officer of the Company, certify, pursuant to 18 U.S.C. § 1350, as adopted pursuant to § 906 of the Sarbanes-Oxley Act of 2002, that to our knowledge:
1.The Report fully complies with the requirements of Section 13(a) or 15(d) of the Securities Exchange Act of 1934; and
2.The information contained in the Report fairly presents, in all material respects, the financial condition and results of operations of the Company.
Dated: November 12, 2024
|
|
|
/s/ Johan (Thijs) Spoor |
|
Johan (Thijs) Spoor |
|
Chief Executive Officer (Principal Executive Officer) |
|
|
|
|
|
|
|
/s/ Jonathan Hunt |
|
Jonathan Hunt |
|
Chief Financial Officer (Principal Financial Officer and Principal Accounting Officer) |
v3.24.3
Document And Entity Information - shares
|
9 Months Ended |
|
Sep. 30, 2024 |
Nov. 07, 2024 |
Cover [Abstract] |
|
|
Entity Central Index Key |
0000728387
|
|
Entity Registrant Name |
PERSPECTIVE THERAPEUTICS, INC.
|
|
Amendment Flag |
false
|
|
Current Fiscal Year End Date |
--12-31
|
|
Document Fiscal Period Focus |
Q3
|
|
Document Fiscal Year Focus |
2024
|
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Document Type |
10-Q
|
|
Document Quarterly Report |
true
|
|
Document Period End Date |
Sep. 30, 2024
|
|
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false
|
|
Entity File Number |
001-33407
|
|
Entity Incorporation, State or Country Code |
DE
|
|
Entity Tax Identification Number |
41-1458152
|
|
Entity Address, Address Line One |
2401 Elliott Avenue, Suite 320
|
|
Entity Address, City or Town |
Seattle
|
|
Entity Address, State or Province |
WA
|
|
Entity Address, Postal Zip Code |
98121
|
|
City Area Code |
206
|
|
Local Phone Number |
676-0900
|
|
Title of 12(b) Security |
Common Stock, $0.001 par value
|
|
Trading Symbol |
CATX
|
|
Security Exchange Name |
NYSEAMER
|
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Entity Current Reporting Status |
Yes
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Yes
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Entity Filer Category |
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v3.24.3
Condensed Consolidated Balance Sheets - USD ($) $ in Thousands |
Sep. 30, 2024 |
Dec. 31, 2023 |
Current assets: |
|
|
|
Cash and cash equivalents |
|
$ 226,443
|
$ 9,238
|
Short-term investments |
|
41,404
|
0
|
Accounts receivable, net of allowance for doubtful accounts: 2024 - $592; 2023 - $650 |
|
217
|
1,165
|
Prepaid expenses and other current assets |
|
2,108
|
1,133
|
Current assets held for sale, discontinued operations |
|
0
|
5,301
|
Total current assets |
|
270,172
|
16,837
|
Noncurrent assets: |
|
|
|
Property and equipment, net |
|
43,792
|
5,576
|
Right-of-use asset, net |
|
2,433
|
747
|
Restricted cash |
|
0
|
182
|
Intangible assets, in-process research and development |
|
50,000
|
50,000
|
Goodwill |
|
24,062
|
24,062
|
Other assets, net |
|
694
|
487
|
Total assets |
|
391,153
|
97,891
|
Current liabilities: |
|
|
|
Accounts payable and accrued expenses |
|
21,813
|
6,909
|
Lease liability |
|
903
|
46
|
Accrued personnel expenses |
|
3,976
|
3,588
|
Note payable |
|
51
|
49
|
Deferred Income (Note 3) |
|
1,400
|
0
|
Current liabilities of discontinued operations |
|
0
|
5,072
|
Total current liabilities |
|
28,143
|
15,664
|
Noncurrent liabilities: |
|
|
|
Lease liability, net of current portion |
|
1,676
|
780
|
Note payable, net of current portion |
|
1,638
|
1,676
|
Deferred Income, net of current portion (Note 3) |
|
26,600
|
0
|
Deferred tax liability |
|
4,592
|
4,592
|
Other noncurrent liabilities |
|
33
|
0
|
Total liabilities |
|
62,682
|
22,712
|
Commitments and contingencies (Note 10) |
|
|
|
Stockholders' equity: |
|
|
|
Preferred stock, $0.001 par value; 7,000,000 shares authorized; 5,000,000 designated Series B convertible preferred stock; no shares issued and outstanding as of September 30, 2024 and December 31, 2023 |
|
0
|
0
|
Common stock, $0.001 par value; 750,000,000 shares authorized; 67,562,781 and 28,180,985 shares issued and outstanding as of September 30, 2024 and December 31, 2023, respectively1 |
[1] |
67
|
28
|
Additional paid-in capital |
[1] |
519,954
|
227,591
|
Accumulated deficit |
|
(191,550)
|
(152,440)
|
Total stockholders' equity |
|
328,471
|
75,179
|
Total liabilities and stockholders' equity |
|
$ 391,153
|
$ 97,891
|
|
|
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v3.24.3
Condensed Consolidated Balance Sheets (Parentheticals) $ in Thousands |
Sep. 30, 2024
USD ($)
$ / shares
shares
|
Dec. 31, 2023
USD ($)
$ / shares
shares
|
Allowance for doubtful accounts | $ |
|
$ 592
|
$ 650
|
Preferred stock, par value | $ / shares |
|
$ 0.001
|
$ 0.001
|
Preferred stock, shares authorized |
|
7,000,000
|
7,000,000
|
Common stock, par value | $ / shares |
|
$ 0.001
|
$ 0.001
|
Common stock, shares authorized |
|
750,000,000
|
750,000,000
|
Common stock, shares issued |
[1] |
67,562,781
|
28,180,985
|
Common stock, shares outstanding |
[1] |
67,562,781
|
28,180,985
|
Series B Convertible Preferred Stock [Member] |
|
|
|
Preferred stock, shares authorized |
|
5,000,000
|
5,000,000
|
Preferred stock, shares issued |
|
0
|
0
|
Preferred stock, shares outstanding |
|
0
|
0
|
|
|
X |
- DefinitionAmount of allowance for credit loss on accounts receivable.
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v3.24.3
Condensed Consolidated Statements of Operations (Unaudited) - USD ($) shares in Thousands, $ in Thousands |
3 Months Ended |
9 Months Ended |
Sep. 30, 2024 |
Sep. 30, 2023 |
Sep. 30, 2024 |
Sep. 30, 2023 |
Income Statement [Abstract] |
|
|
|
|
|
Grant revenue |
|
$ 369
|
$ 276
|
$ 1,220
|
$ 1,097
|
Operating expenses: |
|
|
|
|
|
Research and development |
|
12,028
|
5,552
|
28,755
|
14,231
|
General and administrative |
|
6,975
|
4,474
|
18,367
|
16,124
|
Change in estimate of asset retirement obligation (Note 4) |
|
0
|
0
|
0
|
(15)
|
Loss on disposal of property and equipment |
|
0
|
0
|
0
|
22
|
Total operating expenses |
|
19,003
|
10,026
|
47,122
|
30,362
|
Operating loss |
|
(18,634)
|
(9,750)
|
(45,902)
|
(29,265)
|
Non-operating income (expense): |
|
|
|
|
|
Interest income |
|
3,581
|
204
|
7,868
|
872
|
Interest and other expense |
|
(69)
|
(14)
|
(121)
|
(58)
|
Equity in loss of affiliate |
|
0
|
(12)
|
(6)
|
(12)
|
Total non-operating income (expense), net |
|
3,512
|
178
|
7,741
|
802
|
Net loss from continuing operations |
|
(15,122)
|
(9,572)
|
(38,161)
|
(28,463)
|
Net loss from discontinued operations |
|
0
|
(784)
|
(890)
|
(3,870)
|
Loss recognized on classification as held for sale |
|
0
|
0
|
(59)
|
0
|
Net loss before deferred income tax benefit |
|
(15,122)
|
(10,356)
|
(39,110)
|
(32,333)
|
Deferred income tax benefit |
|
0
|
0
|
0
|
10,500
|
Net loss |
|
$ (15,122)
|
$ (10,356)
|
$ (39,110)
|
$ (21,833)
|
Basic and diluted loss per share: |
|
|
|
|
|
Loss from continuing operations, Basic |
[1] |
$ (0.21)
|
$ (0.34)
|
$ (0.61)
|
$ (0.68)
|
Loss from continuing operations, Diluted |
[1] |
(0.21)
|
(0.34)
|
(0.61)
|
(0.68)
|
Loss from discontinued operations, Basic |
[1] |
0
|
(0.03)
|
(0.01)
|
(0.15)
|
Loss from discontinued operations, Diluted |
[1] |
0
|
(0.03)
|
(0.01)
|
(0.15)
|
Basic loss per share |
[1] |
(0.21)
|
(0.37)
|
(0.62)
|
(0.83)
|
Diluted loss per share |
[1] |
$ (0.21)
|
$ (0.37)
|
$ (0.62)
|
$ (0.83)
|
Weighted average shares used in computing net loss per share: |
|
|
|
|
|
Basic |
[1] |
70,629
|
28,055
|
62,293
|
26,323
|
Diluted |
[1] |
70,629
|
28,055
|
62,293
|
26,323
|
|
|
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v3.24.3
Condensed Consolidated Statements of Cash Flows (Unaudited) - USD ($) $ in Thousands |
3 Months Ended |
9 Months Ended |
12 Months Ended |
Sep. 30, 2024 |
Mar. 31, 2024 |
Sep. 30, 2023 |
Mar. 31, 2023 |
Sep. 30, 2024 |
Sep. 30, 2023 |
Dec. 31, 2023 |
CASH FLOWS FROM OPERATING ACTIVITIES: |
|
|
|
|
|
|
|
|
Net Income (Loss) |
|
$ (15,122)
|
$ (12,284)
|
$ (10,356)
|
$ (371)
|
$ (39,110)
|
$ (21,833)
|
|
Adjustments to reconcile net loss to net cash provided by (used in) operating activities: |
|
|
|
|
|
|
|
|
Foreign currency adjustments |
|
|
|
|
|
39
|
0
|
|
Lease expense |
|
|
|
|
|
100
|
35
|
|
Depreciation expense |
|
|
|
|
|
1,585
|
684
|
|
Write-off of inventory associated with discontinued product |
|
|
|
|
|
0
|
298
|
|
Loss on disposal of property and equipment |
|
|
|
|
|
0
|
22
|
|
Amortization of other assets |
|
|
|
|
|
12
|
30
|
|
Accretion of asset retirement obligation |
|
|
|
|
|
0
|
26
|
|
Equity in loss of affiliate |
|
0
|
|
12
|
|
6
|
12
|
|
Accrued interest on short-term investments |
|
|
|
|
|
(899)
|
0
|
|
Change in allowance for doubtful accounts |
|
|
|
|
|
(58)
|
0
|
|
Change in estimate of asset retirement obligation |
|
0
|
|
0
|
|
0
|
(15)
|
|
Loss on divestiture |
|
|
|
|
|
59
|
0
|
|
Share-based compensation |
|
|
|
|
|
3,327
|
3,018
|
|
Deferred income tax benefit |
|
0
|
|
0
|
|
0
|
(10,500)
|
|
Changes in operating assets and liabilities: |
|
|
|
|
|
|
|
|
Accounts receivable |
|
|
|
|
|
890
|
(368)
|
|
Inventory related to discontinued operations |
|
|
|
|
|
11
|
257
|
|
Prepaid expenses and other current assets |
|
|
|
|
|
(975)
|
12
|
|
Accounts payable and accrued expenses |
|
|
|
|
|
14,937
|
(683)
|
|
Deferred Income |
[1] |
|
|
|
|
28,000
|
0
|
|
Accrued personnel expenses |
|
|
|
|
|
388
|
1,100
|
|
Net cash provided by (used in) operating activities |
|
|
|
|
|
8,312
|
(27,905)
|
|
CASH FLOWS FROM INVESTING ACTIVITIES: |
|
|
|
|
|
|
|
|
Additions to property and equipment |
|
|
|
|
|
(39,800)
|
(983)
|
|
Additions to other assets |
|
|
|
|
|
(24)
|
(18)
|
|
Proceeds from maturity of short-term investments |
|
|
|
|
|
38,225
|
22,764
|
|
Purchases of short-term investments |
|
|
|
|
|
(78,730)
|
0
|
|
Net cash acquired in acquisition of Viewpoint |
|
|
|
|
|
0
|
2,699
|
|
Net cash (used in) provided by investing activities |
|
|
|
|
|
(80,329)
|
24,462
|
|
CASH FLOWS FROM FINANCING ACTIVITIES: |
|
|
|
|
|
|
|
|
Repayment of notes payable |
|
|
|
|
|
(36)
|
(56)
|
|
Proceeds from sales of common stock, pursuant to exercise of warrants, net |
|
|
|
|
|
125
|
0
|
|
Proceeds from sales of common stock, pursuant to exercise of options |
|
|
|
|
|
896
|
554
|
|
Proceeds from the issuance of common stock and Pre-funded Warrants, net |
[1] |
|
|
|
|
288,055
|
0
|
|
Issuance costs related to common stock issued in exchange for Viewpoint common stock |
|
|
|
|
|
0
|
(65)
|
|
Net cash provided by financing activities |
|
|
|
|
|
289,040
|
433
|
|
Net increase (decrease) in cash, cash equivalents and restricted cash |
|
|
|
|
|
217,023
|
(3,010)
|
|
Cash, cash equivalents and restricted cash beginning of period |
|
|
$ 9,420
|
|
$ 21,175
|
9,420
|
21,175
|
$ 21,175
|
CASH, CASH EQUIVALENTS AND RESTRICTED CASH END OF PERIOD |
|
226,443
|
|
18,165
|
|
226,443
|
18,165
|
9,420
|
Reconciliation of cash, cash equivalents and restricted cash to the condensed consolidated balance sheets: |
|
|
|
|
|
|
|
|
Cash and cash equivalents |
|
226,443
|
|
17,983
|
|
226,443
|
17,983
|
9,238
|
Restricted cash |
|
0
|
|
182
|
|
0
|
182
|
182
|
Total cash, cash equivalents and restricted cash shown on the condensed consolidated statements of cash flows |
|
$ 226,443
|
|
$ 18,165
|
|
226,443
|
18,165
|
$ 9,420
|
Supplemental schedule of noncash investing and financing activities: |
|
|
|
|
|
|
|
|
Recognition of operating lease liability and right-of-use asset |
|
|
|
|
|
2,115
|
811
|
|
Additions to property and equipment |
|
|
|
|
|
16,518
|
0
|
|
Fair value of Viewpoint assets acquired including goodwill |
|
|
|
|
|
0
|
85,885
|
|
13,654,507 shares of Perspective Therapeutics common stock issued in exchange for Viewpoint common stock |
|
|
|
|
|
0
|
(54,618)
|
|
Assumption of Viewpoint stock options and warrants at fair value |
|
|
|
|
|
0
|
(7,836)
|
|
Note receivable and accrued interest from Viewpoint forgiven |
|
|
|
|
|
$ 0
|
$ (6,171)
|
|
|
|
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- DefinitionThe amount of fixed assets that an Entity acquires in a noncash (or part noncash) acquisition. Noncash is defined as information about all investing and financing activities of an enterprise during a period that affect recognized assets or liabilities but that do not result in cash receipts or cash payments in the period. "Part noncash" refers to that portion of the transaction not resulting in cash receipts or cash payments in the period.
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- DefinitionThe cash outflow for cost incurred directly with the issuance of an equity security.
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v3.24.3
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- DefinitionThe number of shares issued as [noncash or part noncash] consideration for a business or asset acquired. Noncash is defined as transactions during a period that affect recognized assets or liabilities but that do not result in cash receipts or cash payments in the period. "Part noncash" refers to that portion of the transaction not resulting in cash receipts or cash payments in the period.
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v3.24.3
Condensed Consolidated Statements of Changes in Stockholders' Equity (Unaudited) - USD ($) $ in Thousands |
Total |
Common Stock [Member] |
Additional Paid-in Capital [Member] |
Accumulated Deficit [Member] |
January 2024 Pre-funded Warrants [Member] |
January 2024 Pre-funded Warrants [Member]
Common Stock [Member]
|
[1] |
January 2024 Pre-funded Warrants [Member]
Additional Paid-in Capital [Member]
|
[1] |
January 2024 Pre-funded Warrants [Member]
Accumulated Deficit [Member]
|
May 2024 Pre-funded Warrants [Member] |
May 2024 Pre-funded Warrants [Member]
Common Stock [Member]
|
[1] |
May 2024 Pre-funded Warrants [Member]
Additional Paid-in Capital [Member]
|
[1] |
May 2024 Pre-funded Warrants [Member]
Accumulated Deficit [Member]
|
Public Offering [Member] |
Public Offering [Member]
Common Stock [Member]
|
Public Offering [Member]
Additional Paid-in Capital [Member]
|
[1] |
Public Offering [Member]
Accumulated Deficit [Member]
|
Lantheus Investment Agreement [Member] |
Lantheus Investment Agreement [Member]
Common Stock [Member]
|
Lantheus Investment Agreement [Member]
Additional Paid-in Capital [Member]
|
[1] |
Lantheus Investment Agreement [Member]
Accumulated Deficit [Member]
|
March 2024 Investment Agreement [Member] |
March 2024 Investment Agreement [Member]
Common Stock [Member]
|
March 2024 Investment Agreement [Member]
Additional Paid-in Capital [Member]
|
[1] |
March 2024 Investment Agreement [Member]
Accumulated Deficit [Member]
|
A T M Agreement [Member] |
A T M Agreement [Member]
Common Stock [Member]
|
A T M Agreement [Member]
Additional Paid-in Capital [Member]
|
[1] |
A T M Agreement [Member]
Accumulated Deficit [Member]
|
Registered Offering [Member] |
Registered Offering [Member]
Common Stock [Member]
|
Registered Offering [Member]
Additional Paid-in Capital [Member]
|
[1] |
Registered Offering [Member]
Accumulated Deficit [Member]
|
Balances (in shares) at Dec. 31, 2022 |
[1] |
|
14,211,276
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balances at Dec. 31, 2022 |
|
$ 54,642
|
$ 14
|
[1] |
$ 160,560
|
[1] |
$ (105,932)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Issuance of common stock in exchange for Viewpoint common stock, net(in shares) |
[1] |
|
13,654,507
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Issuance of common stock in exchange for Viewpoint common stock, net |
|
54,553
|
$ 14
|
[1] |
54,539
|
[1] |
0
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Assumption of Viewpoint stock options and warrants at fair value |
|
7,836
|
0
|
[1] |
7,836
|
[1] |
0
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Share-based compensation |
|
1,368
|
0
|
[1] |
1,368
|
[1] |
0
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss |
|
(371)
|
$ 0
|
[1] |
0
|
[1] |
(371)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balances (in shares) at Mar. 31, 2023 |
[1] |
|
27,865,783
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balances at Mar. 31, 2023 |
|
118,028
|
$ 28
|
[1] |
224,303
|
[1] |
(106,303)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balances (in shares) at Dec. 31, 2022 |
[1] |
|
14,211,276
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balances at Dec. 31, 2022 |
|
54,642
|
$ 14
|
[1] |
160,560
|
[1] |
(105,932)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss |
|
(21,833)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balances (in shares) at Sep. 30, 2023 |
[1] |
|
28,057,101
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balances at Sep. 30, 2023 |
|
98,770
|
$ 28
|
[1] |
226,507
|
[1] |
(127,765)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balances (in shares) at Mar. 31, 2023 |
[1] |
|
27,865,783
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balances at Mar. 31, 2023 |
|
118,028
|
$ 28
|
[1] |
224,303
|
[1] |
(106,303)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Issuance of common stock pursuant to exercise options (in shares) |
[1] |
|
182,158
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Issuance of common stock pursuant to exercise of options |
|
532
|
$ 0
|
[1] |
532
|
[1] |
0
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Share-based compensation |
|
1,199
|
0
|
[1] |
1,199
|
[1] |
0
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss |
|
(11,106)
|
$ 0
|
[1] |
0
|
[1] |
(11,106)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balances (in shares) at Jun. 30, 2023 |
[1] |
|
28,047,941
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balances at Jun. 30, 2023 |
|
108,653
|
$ 28
|
[1] |
226,034
|
[1] |
(117,409)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Issuance of common stock pursuant to exercise options (in shares) |
[1] |
|
9,160
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Issuance of common stock pursuant to exercise of options |
|
22
|
$ 0
|
[1] |
22
|
[1] |
0
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Share-based compensation |
|
451
|
0
|
[1] |
451
|
[1] |
0
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss |
|
(10,356)
|
$ 0
|
[1] |
0
|
[1] |
(10,356)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balances (in shares) at Sep. 30, 2023 |
[1] |
|
28,057,101
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balances at Sep. 30, 2023 |
|
98,770
|
$ 28
|
[1] |
226,507
|
[1] |
(127,765)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balances (in shares) at Dec. 31, 2023 |
[1] |
|
28,180,985
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balances at Dec. 31, 2023 |
|
75,179
|
$ 28
|
[1] |
227,591
|
[1] |
(152,440)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Issuance of common stock, net (in shares) |
[1],[2] |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
15,639,954
|
|
|
|
|
5,634,235
|
|
|
|
|
9,200,998
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Issuance of common stock, net |
[2] |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
$ 53,141
|
$ 16
|
[1] |
$ 53,125
|
$ 0
|
$ 20,846
|
$ 6
|
[1] |
$ 20,840
|
$ 0
|
$ 82,019
|
$ 9
|
[1] |
$ 82,010
|
$ 0
|
|
|
|
|
|
|
|
|
|
|
Issuance of Pre-funded Warrants, net |
[2] |
|
|
|
|
|
|
$ 10,208
|
$ 0
|
$ 10,208
|
$ 0
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Issuance of common stock pursuant to exercise options (in shares) |
[1] |
|
35,424
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Issuance of common stock pursuant to exercise of options |
|
126
|
$ 0
|
[1] |
126
|
[1] |
0
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Share-based compensation |
|
656
|
0
|
[1] |
656
|
[1] |
0
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss |
|
(12,284)
|
$ 0
|
[1] |
0
|
[1] |
(12,284)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balances (in shares) at Mar. 31, 2024 |
[1] |
|
58,691,596
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balances at Mar. 31, 2024 |
|
229,891
|
$ 59
|
[1] |
394,556
|
[1] |
(164,724)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balances (in shares) at Dec. 31, 2023 |
[1] |
|
28,180,985
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balances at Dec. 31, 2023 |
|
75,179
|
$ 28
|
[1] |
227,591
|
[1] |
(152,440)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss |
|
(39,110)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balances (in shares) at Sep. 30, 2024 |
[1] |
|
67,562,781
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balances at Sep. 30, 2024 |
|
328,471
|
$ 67
|
[1] |
519,954
|
[1] |
(191,550)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balances (in shares) at Mar. 31, 2024 |
[1] |
|
58,691,596
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balances at Mar. 31, 2024 |
|
229,891
|
$ 59
|
[1] |
394,556
|
[1] |
(164,724)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Issuance of common stock, net (in shares) |
[1],[2] |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
3,535,246
|
|
|
|
|
5,151,588
|
|
|
|
Issuance of common stock, net |
[2] |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
$ 47,933
|
$ 3
|
[1] |
$ 47,930
|
$ 0
|
$ 71,868
|
$ 5
|
[1] |
$ 71,863
|
$ 0
|
Issuance of Pre-funded Warrants, net |
[2] |
|
|
|
|
|
|
|
|
|
|
$ 2,040
|
$ 0
|
$ 2,040
|
$ 0
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Issuance of common stock pursuant to exercise options (in shares) |
[1] |
|
24,450
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Issuance of common stock pursuant to exercise of options |
|
128
|
$ 0
|
[1] |
128
|
[1] |
0
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Issuance of stock pursuant to exercise of common stock warrants |
[1] |
123
|
|
|
123
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Issuance of common stock pursuant to exercise of warrants (in shares) |
[1] |
|
22,401
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Share-based compensation |
|
719
|
$ 0
|
[1] |
719
|
[1] |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cancellation of fractional shares due to the 1-for-10 reverse stock split |
|
(1)
|
$ 0
|
[1] |
(1)
|
[1] |
0
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cancellation of fractional shares due to the 1-for-10 reverse stock split (in shares) |
[1] |
|
(114)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss |
|
(11,704)
|
$ 0
|
[1] |
0
|
[1] |
(11,704)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balances (in shares) at Jun. 30, 2024 |
[1] |
|
67,425,167
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balances at Jun. 30, 2024 |
|
340,997
|
$ 67
|
[1] |
517,358
|
[1] |
(176,428)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Issuance of common stock pursuant to exercise options (in shares) |
[1] |
|
137,229
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Issuance of common stock pursuant to exercise of options |
|
642
|
$ 0
|
[1] |
642
|
[1] |
0
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Issuance of stock pursuant to exercise of common stock warrants |
|
2
|
$ 0
|
[1] |
2
|
[1] |
0
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Issuance of common stock pursuant to exercise of warrants (in shares) |
[1] |
|
385
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Share-based compensation |
|
1,952
|
$ 0
|
[1] |
1,952
|
[1] |
0
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss |
|
(15,122)
|
$ 0
|
[1] |
0
|
[1] |
(15,122)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balances (in shares) at Sep. 30, 2024 |
[1] |
|
67,562,781
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balances at Sep. 30, 2024 |
|
$ 328,471
|
$ 67
|
[1] |
$ 519,954
|
[1] |
$ (191,550)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
X |
- DefinitionAmount of increase in additional paid in capital (APIC) resulting from the assumption of stock options and warrants at fair value.
+ References
+ Details
Name: |
catx_AdjustmentsToAdditionalPaidInCapitalAssumptionOfStockOptionsAndWarrantsAtFairValue |
Namespace Prefix: |
catx_ |
Data Type: |
xbrli:monetaryItemType |
Balance Type: |
credit |
Period Type: |
duration |
|
X |
- DefinitionAdjustments to additional paid in capital, issuance of pre-funded warrants.
+ References
+ Details
Name: |
catx_AdjustmentsToAdditionalPaidInCapitalIssuanceOfPreFundedWarrants |
Namespace Prefix: |
catx_ |
Data Type: |
xbrli:monetaryItemType |
Balance Type: |
credit |
Period Type: |
duration |
|
X |
- DefinitionStock issued during period shares common stock warrant exercised.
+ References
+ Details
Name: |
catx_StockIssuedDuringPeriodSharesCommonStockWarrantExercised |
Namespace Prefix: |
catx_ |
Data Type: |
xbrli:sharesItemType |
Balance Type: |
na |
Period Type: |
duration |
|
X |
- DefinitionStock issued during period value warrant exercises.
+ References
+ Details
Name: |
catx_StockIssuedDuringPeriodValueWarrantExercises |
Namespace Prefix: |
catx_ |
Data Type: |
xbrli:monetaryItemType |
Balance Type: |
credit |
Period Type: |
duration |
|
X |
- DefinitionAmount of increase to additional paid-in capital (APIC) for recognition of cost for award under share-based payment arrangement.
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v3.24.3
Pay vs Performance Disclosure - USD ($) $ in Thousands |
3 Months Ended |
9 Months Ended |
Sep. 30, 2024 |
Jun. 30, 2024 |
Mar. 31, 2024 |
Sep. 30, 2023 |
Jun. 30, 2023 |
Mar. 31, 2023 |
Sep. 30, 2024 |
Sep. 30, 2023 |
Pay vs Performance Disclosure |
|
|
|
|
|
|
|
|
Net Income (Loss) |
$ (15,122)
|
$ (11,704)
|
$ (12,284)
|
$ (10,356)
|
$ (11,106)
|
$ (371)
|
$ (39,110)
|
$ (21,833)
|
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v3.24.3
Note 1 - Basis of Presentation and Summary of Significant Accounting Policies
|
9 Months Ended |
Sep. 30, 2024 |
Organization, Consolidation and Presentation of Financial Statements [Abstract] |
|
Basis of Presentation and Summary of Significant Accounting Policies |
1.Basis of Presentation and Summary of Significant Accounting Policies Perspective Therapeutics, Inc. is developing the next generation of precision-targeted alpha therapies (TAT) for oncology that have the potential to treat a large population of cancer patients across multiple tumor types, including those with metastatic disease. The accompanying unaudited condensed consolidated financial statements are those of Perspective Therapeutics, Inc., and its wholly owned subsidiaries, referred to herein as “Perspective Therapeutics” or the “Company.” All significant intercompany accounts and transactions have been eliminated in consolidation. In the opinion of management, all adjustments necessary for the fair presentation of the condensed consolidated financial statements have been included. These unaudited condensed consolidated financial statements should be read in conjunction with the Company’s audited consolidated financial statements and related notes as set forth in the Company’s Annual Report on Form 10-K for the period ended December 31, 2023 filed with the SEC on March 28, 2024 (2023 Form 10-K). The unaudited condensed consolidated financial statements have been prepared in accordance with generally accepted accounting principles in the United States (U.S. GAAP). Certain information and note disclosures normally included in financial statements prepared in accordance with U.S. GAAP have been condensed or omitted pursuant to those rules and regulations, although the Company believes that the disclosures are adequate for the information not to be misleading. The unaudited condensed consolidated financial statements reflect, in management’s opinion, all adjustments of a normal, recurring nature that are necessary for the fair statement of the Company’s financial position, results of operations and cash flows for the interim periods, but are not necessarily indicative of the results expected for the full fiscal year or any other period. The Company anticipates that as the result of continuing operating losses and the significant net operating losses available from prior fiscal years, its effective income tax rate for fiscal year 2024 will be 0%. Merger On February 3, 2023, the Company completed the merger of Isoray Acquisition Corp., a Delaware corporation and wholly owned subsidiary of the Company, with Viewpoint Molecular Targeting, Inc. (Viewpoint) (such transaction being the Merger). Pursuant to the Merger, the Company issued 13,654,507 shares of its common stock, par value $0.001 per share (Common Stock), representing approximately 49% of its fully diluted outstanding capital stock as of the close of the Merger. Viewpoint is an alpha-particle radiopharmaceutical company in the alpha-emitter market developing oncology therapeutics and complementary imaging agents. For additional information, see Note 14, Merger, in this Form 10-Q. Discontinued Operations On April 12, 2024, the Company completed the sale of its Cesium-131 brachytherapy business and substantially all of the assets of Isoray Medical, Inc. (Isoray), a wholly owned subsidiary of Perspective Therapeutics, to GT Medical Technologies, Inc., a Delaware corporation (GT Medical) (such transaction being the GT Medical Closing). Pursuant to the GT Medical Closing, GT Medical issued to Isoray 279,516 shares of GT Medical’s common stock, par value $0.0001 per share, representing 0.5% of GT Medical’s issued and outstanding capital stock on a fully diluted basis as of the closing. Accordingly, the financial information and operating results of the Cesium-131 brachytherapy business have been presented as discontinued operations in the condensed consolidated financial statements for all periods presented. Unless otherwise noted, discussion within these notes to the condensed consolidated financial statements relates to continuing operations. For additional information, see Note 4, Discontinued Operations, in this Form 10-Q. Reverse Stock Split On June 14, 2024, the Company effected a 1-for-10 reverse stock split (Reverse Split) of the Company’s issued and outstanding shares of Common Stock, and the Common Stock began trading on a split-adjusted basis on June 17, 2024. The Reverse Split did not reduce the total number of authorized shares of Common Stock or the Company’s preferred stock (Preferred Stock), or change the par values of the Common Stock or Preferred Stock. The Reverse Split affected all stockholders uniformly and did not affect any stockholder’s ownership percentage of the shares of Common Stock (except to the extent that the Reverse Split resulted in some of the stockholders receiving cash in lieu of fractional shares). All outstanding options and warrants entitling their holders to purchase shares of Common Stock were adjusted as a result of the Reverse Split, in accordance with the terms of each such security. In addition, the number of shares reserved for future issuance pursuant to the Company’s equity incentive plans was also adjusted accordingly. As a result, all historical per share data, number of shares issued and outstanding, and outstanding options and warrants for the periods presented in the accompanying condensed consolidated financial statements and notes thereto have been adjusted retroactively in this Form 10-Q, where applicable, to reflect the Reverse Split. Liquidity The Company assesses its liquidity in terms of its ability to generate cash to fund its operating, investing and financing activities. The Company has had a history of operating losses and an absence of significant recurring cash inflows from revenue. At September 30, 2024, the Company had cash, cash equivalents and short-term investments of $267.8 million and total accumulated deficit of $191.6 million. The Company has historically financed its operations primarily through selling equity. The Company believes that its $267.8 million of cash, cash equivalents and short-term investments as of September 30, 2024 will enable it to fund its current planned operations into mid-2026, though it may raise additional capital through a combination of equity offerings, debt financings, collaborations, strategic alliances and marketing, distribution or licensing arrangements and/or government funding and grants. The accompanying unaudited condensed consolidated financial statements have been prepared on a going concern basis, which contemplates the realization of assets and satisfaction of liabilities in the ordinary course of business. The operating plan may change as a result of many factors currently unknown to management, and there can be no assurance that the current operating plan will be achieved in the timeframe anticipated by management or at all, and the Company may need to seek additional funds sooner than anticipated. The unaudited condensed consolidated financial statements do not include any adjustments relating to the recoverability and classification of recorded asset amounts or the amounts and classification of liabilities that might result from potential unknown factors. Reclassifications In addition to the discontinued operations discussed above, during the first quarter of 2024, the Company made certain reclassifications to prior period amounts in the condensed consolidated financial statements and accompanying notes to conform to the current period presentation. The reclassification of these items had no impact on net loss, financial position or cash flows in the current or prior periods. Specifically, accrued payroll and related taxes and accrued vacation were combined to create accrued personnel, and accrued protocol expense and accrued waste disposal were included in accounts payable and accrued expenses, all of which are presented on the condensed consolidated balance sheets and condensed consolidated statement of cash flows. Significant Accounting Policies The Company’s significant accounting policies and recent accounting pronouncements are described in Note 2, Summary of Significant Accounting Policies, to the consolidated financial statements in Item 8 of the 2023 Form 10-K. There have been no changes to the Company’s significant accounting policies, and the Company has not adopted any significant accounting policies during the nine months ended September 30, 2024.
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- DefinitionThe entire disclosure for the organization, consolidation and basis of presentation of financial statements disclosure, and significant accounting policies of the reporting entity. May be provided in more than one note to the financial statements, as long as users are provided with an understanding of (1) the significant judgments and assumptions made by an enterprise in determining whether it must consolidate a VIE and/or disclose information about its involvement with a VIE, (2) the nature of restrictions on a consolidated VIE's assets reported by an enterprise in its statement of financial position, including the carrying amounts of such assets, (3) the nature of, and changes in, the risks associated with an enterprise's involvement with the VIE, and (4) how an enterprise's involvement with the VIE affects the enterprise's financial position, financial performance, and cash flows. Describes procedure if disclosures are provided in more than one note to the financial statements.
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v3.24.3
Note 2 - Loss Per Share
|
9 Months Ended |
Sep. 30, 2024 |
Earnings Per Share [Abstract] |
|
Loss Per Share |
Basic and diluted loss per share is calculated by dividing net loss by the weighted average number of shares of Common Stock outstanding and does not include the impact of any potentially dilutive common stock equivalents. In January 2024 and May 2024, the Company issued pre-funded warrants in connection with the Public Offering (as defined below) and the Registered Offering (as defined below), respectively (see Note 3, Investments and Agreements, in this Form 10-Q). As the pre-funded warrants’ exercise price is nominal and there are no conditions that must be satisfied prior to their exercise, the pre-funded warrants are included in the calculation of the basic and diluted earnings per share as of September 30, 2024. At each of September 30, 2024 and 2023, the calculation of diluted weighted average shares did not include common stock warrants or options that were potentially convertible into Common Stock as those would be antidilutive due to the Company’s net loss position. Securities not considered in the calculation of diluted loss per share, but that could be dilutive in the future, are as follows (in thousands):
|
|
|
|
|
|
|
|
|
|
|
September 30, 2024 |
|
|
September 30, 2023 |
|
Common stock warrants |
|
|
416 |
|
|
|
576 |
|
Common stock options |
|
|
7,252 |
|
|
|
4,468 |
|
Total potential dilutive securities |
|
|
7,668 |
|
|
|
5,044 |
|
Effective upon the closing of the Merger with Viewpoint on February 3, 2023, the Company assumed 338,709 warrants to purchase shares of Common Stock with an exercise price of $2.70 per share and 2,426,342 options to purchase shares of Common Stock with exercise prices ranging from $1.30 to $3.00 per share.
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- DefinitionThe entire disclosure for earnings per share.
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v3.24.3
Note 3 - Investments and Agreements
|
9 Months Ended |
Sep. 30, 2024 |
Investment Agreements [Abstract] |
|
Investments and Agreements |
3.Investments and Agreements 2024 At-the-Market (ATM) Agreement On August 13, 2024, the Company entered into a Controlled Equity OfferingSM Sales Agreement (2024 ATM Agreement) with Cantor Fitzgerald & Co. and RBC Capital Markets, LLC (each, an ATM Agent, and together, the ATM Agents) pursuant to which the Company from time to time may offer and sell shares (2024 ATM Shares) of its Common Stock, through or to the ATM Agents having an aggregate sales price of up to $250.0 million. Subject to the terms and conditions of the 2024 ATM Agreement, each ATM Agent is required to use its commercially reasonable efforts to sell the ATM Shares from time to time, based upon the Company’s instructions. The Company has provided the ATM Agents with customary indemnification rights, and the ATM Agents will be entitled to a commission of up to 3.0% of the gross proceeds from each sale of the ATM Shares effectuated through or to the applicable ATM Agent selling the ATM Shares. Sales of the 2024 ATM Shares, if any, under the 2024 ATM Agreement may be made in transactions that are deemed to be “at the market offerings” as defined in Rule 415 under the Securities Act of 1933, as amended. The Company has no obligation to sell any of the 2024 ATM Shares and may at any time suspend offers under the 2024 ATM Agreement or terminate the 2024 ATM Agreement. The Common Stock to be sold under the 2024 ATM Agreement, if any, will be issued and sold pursuant to the Company’s automatic shelf registration statement on Form S-3 (File No. 333-279692) (the May 2024 Registration Statement), which became effective upon filing with the SEC on May 24, 2024. On August 13, 2024, the Company filed a prospectus supplement to the May 2024 Registration Statement with the SEC in connection with the offer and sale of the 2024 ATM Shares pursuant to the 2024 ATM Agreement. As of September 30, 2024, the Company has not completed any transactions pursuant to the 2024 ATM Agreement. May 2024 Registered Offering On May 24, 2024, the Company entered into an underwriting agreement with BofA Securities, Inc., as representative of the underwriters named therein, in connection with its previously announced underwritten offering (Registered Offering) of 5,151,588 shares (Registered Offering Shares) of Common Stock and, in lieu of Registered Offering Shares to certain investors, pre-funded warrants (May 2024 Pre-funded Warrants) to purchase 146,425 shares of Common Stock. The price to the investors for the Registered Offering Shares was $15.10 per Registered Offering Share, and the price to the investors for the May 2024 Pre-funded Warrants was $15.09 per May 2024 Pre-funded Warrant, which represents the per share price for the Registered Offering Shares less the $0.01 per share exercise price for each such May 2024 Pre-funded Warrant. The Registered Offering closed on May 29, 2024. BofA Securities, Inc., Oppenheimer & Co. Inc. and RBC Capital Markets, LLC acted as joint book-running managers for the Registered Offering and B. Riley Securities, Inc. acted as a co-manager for the Registered Offering. JonesTrading Institutional Services LLC acted as a financial advisor for the Registered Offering. The gross proceeds to the Company from the Registered Offering were approximately $80.0 million, before underwriting discounts and commissions and estimated expenses of the Registered Offering. The Registered Offering was made pursuant to the May 2024 Registration Statement, a related base prospectus, free writing prospectus and prospectus supplement each dated May 24, 2024. The May 2024 Pre-funded Warrants became exercisable subsequent to the filing and effectiveness of an amendment to the Company’s Amended and Restated Certificate of Incorporation with the Secretary of State of the State of Delaware on June 14, 2024. The exercise price and the number of shares of Common Stock issuable upon exercise of each May 2024 Pre-funded Warrant are subject to appropriate adjustment in the event of certain stock dividends and distributions, stock splits, stock combinations, reclassifications or similar events affecting the Common Stock as well as upon any distribution of assets, including cash, stock or other property, to the Company’s stockholders. The May 2024 Pre-funded Warrants will not expire and are exercisable in cash or by means of a cashless exercise. A holder of May 2024 Pre-funded Warrants may not exercise such May 2024 Pre-funded Warrants if the aggregate number of shares of Common Stock beneficially owned by such holder, together with its affiliates, would be more than 4.99% or 9.99%, as elected by such holder, of the issued and outstanding shares of Common Stock following such exercise, as such percentage ownership is determined in accordance with the terms of the May 2024 Pre-funded Warrants. A holder of May 2024 Pre-funded Warrants may increase or decrease this percentage not in excess of 19.99% by providing at least 61 days’ prior notice to the Company. March 2024 Private Placement with Institutional Investors On March 4, 2024, the Company entered into an investment agreement (the March 2024 Investment Agreement) with certain accredited institutional investors (Institutional Investors) pursuant to which the Company agreed to issue and sell, in a private placement (the March 2024 Private Placement), 9,200,998 shares of Common Stock, for a purchase price of $9.50 per share, representing the closing price of the Common Stock on March 1, 2024. The closing of the March 2024 Private Placement occurred on March 6, 2024. The gross proceeds to the Company from the March 2024 Private Placement were approximately $87.4 million, before deducting fees payable to the Placement Agents (as defined below) and other estimated transaction expenses. The March 2024 Private Placement was conducted pursuant to a Placement Agency Agreement, dated March 4, 2024 (the Placement Agency Agreement), by and between the Company and Oppenheimer & Co. Inc., as representative of the placement agents named therein (the Placement Agents). Per the Placement Agency Agreement, the Company agreed to: (i) pay the Placement Agents a cash fee equal to 5.85% of the gross proceeds received by the Company from the sale of the shares; and (ii) reimburse the Placement Agents for certain fees and expenses. Lantheus Agreements Investment Agreement On January 8, 2024, the Company entered into an investment agreement (the Lantheus Investment Agreement) with Lantheus Alpha Therapy, LLC, a Delaware limited liability company and wholly owned subsidiary of Lantheus Holdings, Inc. (Lantheus), pursuant to which the Company agreed to sell and issue to Lantheus in a private placement transaction certain shares (the Lantheus Shares) of Common Stock. The closing of the purchase and sale of the Lantheus Shares to Lantheus by the Company (the Lantheus Closing) was subject to the Company raising at least $50.0 million of gross proceeds (excluding Lantheus’ investment) in a qualifying third-party financing transaction, which occurred on January 22, 2024. The number of Lantheus Shares sold was 5,634,235, representing 19.99% of the outstanding shares of Common Stock as of January 8, 2024. Pursuant to the Lantheus Investment Agreement, the Company agreed to cooperate in good faith to negotiate and enter into a registration rights agreement with Lantheus, obligating the Company to file a registration statement on Form S-3 with the SEC to register for resale the Lantheus Shares issued at the Lantheus Closing. The Company filed such Form S-3 on March 29, 2024, and the SEC declared it effective on April 9, 2024 (File No. 333-278362). The Lantheus Investment Agreement also contains agreements of the Company and Lantheus whereby Lantheus is provided certain board observer and information rights of the Company, as well as standstill provisions prohibiting Lantheus from taking certain actions for a specified period of time, subject to certain exceptions. The Lantheus Investment Agreement also provides Lantheus with certain pro rata participation rights to maintain its ownership position in the Company in the event that the Company makes any public or non-public offering of any equity or voting interests in the Company or any securities that are convertible or exchangeable into (or exercisable for) equity or voting interests in the Company, subject to certain exceptions. Pursuant to the Lantheus Investment Agreement, the Company is required to notify Lantheus within 10 business days of the end of a fiscal quarter in which the Company issued shares of Common Stock pursuant to that certain At Market Issuance Sales Agreement among the Company, Oppenheimer & Co. Inc., B. Riley Securities, Inc., and JonesTrading Institutional Services LLC dated November 17, 2023 (the ATM Agreement), of (i) the number of shares of Common Stock issued during such fiscal quarter pursuant to the ATM Agreement and (ii) the average price per share received by the Company before commissions (the ATM Average Price). Upon receipt of such notice, Lantheus may elect, at its option, to purchase all or a portion of its Pro Rata Portion (as defined in the Lantheus Investment Agreement) of such shares at an aggregate price equal to the number of shares purchased multiplied by the ATM Average Price for such quarter (the ATM Participation Right). Pursuant to the Lantheus Investment Agreement, Lantheus may not exercise the ATM Participation Right more than two times per calendar year. Asset Purchase Agreement On January 8, 2024, the Company entered into an Asset Purchase Agreement (the Progenics APA) with Progenics Pharmaceuticals, Inc., a Delaware corporation (Progenics) and affiliate of Lantheus, pursuant to which the Company acquired certain assets and the associated lease of Progenics’ radiopharmaceutical manufacturing facility in Somerset, New Jersey for a purchase price of $8.0 million in cash. The transactions contemplated by the Progenics APA closed on March 1, 2024. Option Agreement On January 8, 2024, the Company entered into an option agreement (the Option Agreement) with Lantheus whereby Lantheus was granted an exclusive option to negotiate an exclusive, worldwide, royalty- and milestone-bearing right and license to [212Pb]VMT-α-NET, the Company’s clinical-stage alpha therapy developed for the treatment of neuroendocrine tumors. If good-faith negotiations fail, Lantheus has a one-year right to reenter negotiations if a third party offers to purchase or license the [212Pb]VMT-α-NET program. Additionally, Lantheus has a right to co-fund the Investigational New Drug (IND) application, enabling studies for early-stage therapeutic candidates targeting prostate-specific membrane antigen and gastrin-releasing peptide receptor and, prior to IND filing, a right to negotiate for an exclusive license to such candidates. In consideration of the rights granted by the Company to Lantheus pursuant to the Option Agreement, Lantheus paid to the Company a one-time payment of $28.0 million, subject to certain withholding provisions associated with the closing of the Progenics APA. Under the terms of the Option Agreement, Lantheus also has a right of first offer and last look protections for any third-party merger and acquisition transactions involving the Company for a 12-month period beginning on January 8, 2024. The Company determined that the Option Agreement should be accounted for as a research and development arrangement in accordance with Accounting Standards Codification (ASC) 730-20, Research and Development Arrangements, as Lantheus held approximately 19.9% of the Company’s outstanding Common Stock at March 31, 2024. The Option Agreement contains no repayment provisions, does not create any obligation to enter into any license, transfer or sale agreements with Lantheus, and does not restrict the use of the funds in any way. Accordingly, the balance sheet reports current and long-term liabilities related to these options under the caption, “Deferred Income.” The values for each distinct option within the Option Agreement were determined by estimating the fair value of each distinct option by a third-party valuation firm and the liabilities will be recognized as income in the condensed consolidated statement of operations as the various options expire. January 2024 Public Offering On January 17, 2024, the Company entered into an underwriting agreement (Underwriting Agreement) with Oppenheimer & Co. Inc., as representative of the underwriters named therein (the Underwriters), in connection with its previously announced underwritten public offering (Public Offering) of 13,207,521 shares (Public Shares) of Common Stock and, in lieu of Public Shares to certain investors, pre-funded warrants (Jan. 2024 Pre-funded Warrants) to purchase 3,008,694 shares of Common Stock. The price to the public for the Public Shares was $3.70 per Public Share, and the price to the public for the Jan. 2024 Pre-funded Warrants was $3.69 per Jan. 2024 Pre-funded Warrant, which represents the per share price for the Public Shares less the $0.01 per share exercise price for each such Jan. 2024 Pre-funded Warrant. Under the terms of the Underwriting Agreement, the Company granted the Underwriters an option, exercisable for 30 days, to purchase up to an additional 2,432,432 shares of Common Stock at the same price per share as the Public Shares, which was fully exercised by the Underwriters on January 18, 2024. The Public Offering closed on January 22, 2024. The gross proceeds to the Company from the Public Offering were approximately $69.0 million, before underwriting discounts and commissions and estimated expenses of the Public Offering. The Public Offering was made pursuant to the Company’s shelf registration statement on Form S-3 (File No. 333-275638), declared effective by the SEC on December 14, 2023, a base prospectus dated December 14, 2023, and the related prospectus supplement dated January 17, 2024. The Jan. 2024 Pre-funded Warrants are exercisable at any time after the date of issuance. The exercise price and the number of shares of Common Stock issuable upon exercise of each Jan. 2024 Pre-funded Warrant are subject to appropriate adjustment in the event of certain stock dividends and distributions, stock splits, stock combinations, reclassifications or similar events affecting the Common Stock as well as upon any distribution of assets, including cash, stock or other property, to the Company’s stockholders. The Jan. 2024 Pre-funded Warrants will not expire and are exercisable in cash or by means of a cashless exercise. A holder of Jan. 2024 Pre-funded Warrants may not exercise such Jan. 2024 Pre-funded Warrants if the aggregate number of shares of Common Stock beneficially owned by such holder, together with its affiliates, would beneficially own more than 4.99% of the issued and outstanding shares of Common Stock following such exercise, as such percentage ownership is determined in accordance with the terms of the Jan. 2024 Pre-funded Warrants. A holder of Jan. 2024 Pre-funded Warrants may increase or decrease this percentage not in excess of 19.99% by providing at least 61 days’ prior notice to the Company. 2023 ATM Agreement The Company entered into an ATM Issuance Sales Agreement, dated November 17, 2023, by and among the Company, Oppenheimer & Co., Inc., B. Riley Securities, Inc. and JonesTrading Institutional Services LLC (2023 ATM Agreement). Pursuant to the 2023 ATM Agreement, the Company established an ATM equity program under which it may offer and sell shares of its Common Stock, from time to time. On November 17, 2023, the Company filed a shelf registration statement on Form S-3 with the SEC (File No. 333-275638) and accompanying base prospectus, declared effective by the SEC on December 14, 2023, for the offer and sale of up to $200.0 million of its securities (December 2023 Registration Statement). Also on November 17, 2023, the Company filed a prospectus supplement with the SEC in connection with the offering of up to $50.0 million of shares of its Common Stock pursuant to the 2023 ATM Agreement under the December 2023 Registration Statement. In December 2023, the Company sold 123,882 shares under the 2023 ATM Agreement at an average price of approximately $3.03 per common share for gross proceeds of approximately $0.4 million. On April 11, 2024, the Company sold 3,535,246 shares of its Common Stock under the 2023 ATM Agreement at an average price of approximately $14.00 per common share, resulting in gross proceeds of approximately $49.5 million. On May 25, 2024, the Company terminated the offering of securities pursuant to the December 2023 Registration Statement in connection with the filing and effectiveness of the May 2024 Registration Statement. On August 7, 2024, the Company delivered written notice to Oppenheimer & Co., Inc., B. Riley Securities, Inc. and JonesTrading Institutional Services LLC that it was terminating the 2023 ATM Sales Agreement, which termination became effective August 12, 2024. For additional information related to certain of the agreements discussed above, see Note 20, Subsequent Events, in the Company’s 2023 Form 10-K.
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v3.24.3
Note 4 - Discontinued Operations
|
9 Months Ended |
Sep. 30, 2024 |
Discontinued Operations and Disposal Groups [Abstract] |
|
Discontinued Operations |
4.Discontinued Operations The GT Medical Closing occurred on April 12, 2024 (GT Medical Closing Date). Previously, the Company announced that on December 7, 2023, Isoray entered into an Asset Purchase Agreement (GT Medical APA) by and among Isoray, the Company, and GT Medical pursuant to which Isoray would sell to GT Medical, and GT Medical would purchase from Isoray, all of Isoray’s right, title and interest in and to substantially all of the assets of Isoray related to Isoray’s commercial Cesium-131 business (the Business) including equipment, certain contracts, inventory and intellectual property. Subject to limited exceptions set forth in the GT Medical APA, GT Medical did not assume the liabilities of Isoray. Pursuant to the terms of, and subject to the conditions specified in, the GT Medical APA, at the GT Medical Closing, (i) GT Medical issued to Isoray 279,516 shares of GT Medical’s common stock, par value $0.0001 per share, representing 0.5% of GT Medical’s issued and outstanding capital stock on a fully diluted basis as of the GT Medical Closing Date and (ii) Isoray has the right to receive, and GT Medical is obligated to pay, certain cash royalty payments during each of the first four years beginning upon the GT Medical Closing Date (each such year, a Measurement Period), as summarized below: •with respect to GT Medical’s net sales of Cesium-131 brachytherapy seeds for cases that do not utilize GT Medical’s GammaTile Therapy: (a) if such net sales for a Measurement Period are $10.0 million or less, 3.0% of such net sales; (b) if such net sales for a Measurement Period are greater than $10.0 million and less than $15.0 million, 4.0% of such net sales; and (c) if such net sales for a Measurement Period are $15.0 million or more, 5.0% of such net sales; and •with respect to GT Medical’s net sales of GT Medical’s GammaTile Therapy utilizing Cesium-131 brachytherapy seeds: 0.5% of such net sales for a Measurement Period. In accordance with ASC 205-20, Presentation of Financial Statements – Discontinued Operations, the following table presents the major classes of assets and liabilities of discontinued operations of the Business reported in the condensed consolidated balance sheets and prior year amounts have been reclassified.
|
|
|
|
|
|
|
|
|
|
|
September 30, 2024 |
|
|
December 31, 2023 |
|
(in thousands) |
|
|
|
|
|
|
Assets held for sale of discontinued operations, current |
|
|
|
|
|
|
Inventory |
|
$ |
- |
|
|
$ |
3,148 |
|
Prepaid expenses and other current assets |
|
|
- |
|
|
|
169 |
|
Property and equipment, net |
|
|
- |
|
|
|
1,263 |
|
Right-of-use asset, net |
|
|
- |
|
|
|
676 |
|
Other assets, net |
|
|
- |
|
|
|
45 |
|
Total current assets held for sale of discontinued operations |
|
$ |
- |
|
|
$ |
5,301 |
|
|
|
|
|
|
|
|
Liabilities held for sale of discontinued operations, current |
|
|
|
|
|
|
Lease liability |
|
$ |
- |
|
|
$ |
677 |
|
Asset retirement obligation |
|
|
- |
|
|
|
225 |
|
Loss recognized on classification as held for sale |
|
|
- |
|
|
|
4,170 |
|
Total current liabilities of discontinued operations |
|
$ |
- |
|
|
$ |
5,072 |
|
The following table presents the components of discontinued operations in relation to the Business reported in the unaudited condensed consolidated statements of operations (in thousands):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended September 30, |
|
|
Nine Months Ended September 30, |
|
|
|
2024 |
|
|
2023 |
|
|
2024 |
|
|
2023 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Sales, net |
|
$ |
- |
|
|
$ |
1,909 |
|
|
$ |
2,178 |
|
|
$ |
5,239 |
|
Cost of sales |
|
|
- |
|
|
|
1,447 |
|
|
|
1,564 |
|
|
|
4,863 |
|
Gross profit |
|
|
- |
|
|
|
462 |
|
|
|
614 |
|
|
|
376 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Operating expenses: |
|
|
|
|
|
|
|
|
|
|
|
|
Research and development |
|
|
- |
|
|
|
169 |
|
|
|
69 |
|
|
|
1,000 |
|
Sales and marketing |
|
|
- |
|
|
|
855 |
|
|
|
941 |
|
|
|
2,578 |
|
General and administrative |
|
|
- |
|
|
|
222 |
|
|
|
494 |
|
|
|
668 |
|
Total operating expenses |
|
|
- |
|
|
|
1,246 |
|
|
|
1,504 |
|
|
|
4,246 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total loss from discontinued operations |
|
$ |
- |
|
|
$ |
(784 |
) |
|
$ |
(890 |
) |
|
$ |
(3,870 |
) |
The Company determined the loss recognized on classification as held for sale by identifying the assets and liabilities that are included in the GT Medical APA and are included in the table above. Additionally, the loss recognized on classification as held for sale was determined using the estimated fair value of the GT Medical stock of $0.2 million received less the carrying value of the net assets sold. The fair value of the stock received was determined based on information provided to the Company by GT Medical from a current valuation study that was prepared for them. Excluded from the calculation of the loss are contingent royalties that could be received from future sales. Certain amounts included in the unaudited condensed consolidated statements of cash flows related to the discontinued operations are as follows (in thousands):
|
|
|
|
|
|
|
|
|
|
|
Nine Months Ended September 30, |
|
|
|
2024 |
|
|
2023 |
|
|
|
|
|
|
|
|
Depreciation |
|
$ |
- |
|
|
$ |
171 |
|
Amortization |
|
|
- |
|
|
|
27 |
|
Write-off of inventory associated with discontinued product |
|
|
- |
|
|
|
298 |
|
Share-based compensation |
|
|
166 |
|
|
|
568 |
|
Additions to property and equipment |
|
|
- |
|
|
|
287 |
|
The Company previously had a restricted cash account to provide collateral for the decommissioning of its leased facility for Cesium-131 production. This facility lease was assumed by GT Medical as part of the GT Medical APA which included the commitment to decommission the facility. The Company has subsequently moved the full balance of the restricted cash account to its general operating cash accounts. For the three and nine months ended September 30, 2024 and 2023, there was no provision (benefit) for income taxes recorded related to the discontinued operations. Additionally, the Company is in a loss position and has recorded a full valuation allowance for the deferred tax assets associated with the discontinued operations.
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v3.24.3
Note 5 - Property and Equipment
|
9 Months Ended |
Sep. 30, 2024 |
Notes To Financial Statements [Abstract] |
|
Property and Equipment |
On July 15, 2024, August 2, 2024 and October 31, 2024, the Company purchased a building located in the Houston, Texas, metropolitan area for $4.7 million, a building in the Chicago, Illinois, metropolitan area for $5.0 million, and a building in the Los Angeles, California, metropolitan area for $11.0 million, respectively, which it intends to use for the manufacture of its program candidates upon completion of modifications and installation of equipment. On September 18, 2024, the Company entered into a Master Equipment and Services Agreement (MESA) and statements of work (SOWs) thereunder with Comecer SpA (Comecer), pursuant to which the Company agreed to purchase from Comecer manufacturing equipment for the production of the Company’s radiopharmaceutical products including, but not limited to, isotope processing hot cells and production suites and related equipment (collectively, the Deliverables) and services for installation and validation of the Deliverables at several of the Company’s production facilities in the United States. The aggregate consideration for such equipment and services pursuant to the MESA and SOWs is approximately €49.0 million payable in cash, excluding certain incidental costs such as taxes, customs and duties, local transport, insurance and rigging. The Company may also elect to purchase certain additional equipment and services pursuant to the SOWs. The MESA provides for the payment of certain amounts in installments over the course of the production, installation and validation of the Deliverables. The Company’s property and equipment consisted of the following as of:
|
|
|
|
|
|
|
|
|
|
|
September 30, 2024 |
|
|
December 31, 2023 |
|
|
|
(in thousands) |
|
Building |
|
$ |
1,770 |
|
|
$ |
1,770 |
|
Land |
|
|
1,283 |
|
|
|
1,283 |
|
Equipment |
|
|
10,601 |
|
|
|
2,683 |
|
Leasehold improvements |
|
|
3,497 |
|
|
|
179 |
|
Other1 |
|
|
28,895 |
|
|
|
330 |
|
Property and equipment |
|
|
46,046 |
|
|
|
6,245 |
|
Less accumulated depreciation |
|
|
(2,254 |
) |
|
|
(669 |
) |
Property and equipment, net |
|
$ |
43,792 |
|
|
$ |
5,576 |
|
1.Property and equipment not placed in service are items that meet the capitalization threshold, or which management believes will meet the threshold at the time of completion and which have yet to be placed into service as of the date of the balance sheets and, therefore, no depreciation expense has been recognized.
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- DefinitionThe entire disclosure for long-lived, physical asset used in normal conduct of business and not intended for resale. Includes, but is not limited to, work of art, historical treasure, and similar asset classified as collections.
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v3.24.3
Note 6 - Goodwill and Other Intangible Assets
|
9 Months Ended |
Sep. 30, 2024 |
Goodwill and Intangible Assets Disclosure [Abstract] |
|
Goodwill and Other Intangible Assets |
6.Goodwill and Other Intangible Assets Goodwill The carrying amount of goodwill as of both September 30, 2024 and December 31, 2023 was $24.1 million and has been recorded in connection with the Company’s Merger of Viewpoint in February 2023. The Company tests goodwill and indefinite-lived intangible assets for impairment during the fourth quarter of each year, or more frequently should circumstances change or events occur that would more likely than not reduce the fair value of its assets. No testing was deemed necessary during the three and nine months ended September 30, 2024. The following table summarizes the components of the Company’s other intangible assets (in thousands):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
September 30, 2024 |
|
|
|
Cost |
|
|
Accumulated Amortization |
|
|
Net Carrying Value |
|
Indefinite-lived intangible assets |
|
|
|
|
|
|
|
|
|
In-process research and development |
|
$ |
50,000 |
|
|
$ |
- |
|
|
$ |
50,000 |
|
Total |
|
$ |
50,000 |
|
|
$ |
- |
|
|
$ |
50,000 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
December 31, 2023 |
|
|
|
Cost |
|
|
Accumulated Amortization |
|
|
Net Carrying Value |
|
Indefinite-lived intangible assets |
|
|
|
|
|
|
|
|
|
In-process research and development |
|
$ |
50,000 |
|
|
$ |
- |
|
|
$ |
50,000 |
|
Total |
|
$ |
50,000 |
|
|
$ |
- |
|
|
$ |
50,000 |
|
The Company’s IPR&D assets represent the estimated fair value of Viewpoint’s pipeline of radiotherapy product candidates acquired in February 2023. The estimated fair value of the IPR&D assets at the acquisition date was determined using a probability-weighted income approach, which discounts expected future cash flows to present value. The projected cash flow estimates for Viewpoint’s pipeline of radiotherapy program candidates were based on certain key assumptions, including estimates of future revenue and expenses, taking into account the stage of development of the technology at the Merger date and the time and resources needed to complete development.
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v3.24.3
Note 7 - Held-to-Maturity Investments
|
9 Months Ended |
Sep. 30, 2024 |
Investments, Debt and Equity Securities [Abstract] |
|
Held-to-Maturity Investments |
7.Held-to-Maturity Investments The following table summarizes the carrying values and fair values of the Company’s financial instruments (in thousands):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
September 30, 2024 |
|
|
|
Amortized Cost |
|
|
Gross Unrealized Gains |
|
|
Gross Unrealized Losses |
|
|
Estimated Fair Value |
|
U.S. Treasury Bills |
|
$ |
41,404 |
|
|
$ |
11 |
|
|
$ |
- |
|
|
$ |
41,415 |
|
The Company has investments in U.S. Treasury Bills, some of which mature over a period greater than 90 days and are classified as short-term investments. The U.S. Treasury Bills are carried at amortized cost and classified as held-to-maturity as the Company has the intent and the ability to hold them until they mature. The carrying value of the U.S. Treasury Bills are adjusted for accretion of discounts over the remaining life of the investment. Income related to the U.S. Treasury Bills is recognized in interest income in the Company’s condensed consolidated statement of operations. As of December 31, 2023, the Company had no held-to-maturity investments, and no held-to-maturity investments were presented in cash and cash equivalents on its condensed consolidated balance sheet.
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v3.24.3
Note 8 - Fair Value Measurements
|
9 Months Ended |
Sep. 30, 2024 |
Fair Value Disclosures [Abstract] |
|
Fair Value Measurements |
8.Fair Value Measurements Fair value is defined as an exit price, representing the amount that would be received to sell an asset or paid to transfer a liability in an orderly transaction between market participants. As such, fair value is a market-based measurement that should be determined based on assumptions that market participants would use in pricing an asset or liability. As a basis for considering such assumptions, the accounting guidance establishes a three-tier fair value hierarchy, which prioritizes the inputs used in measuring fair value as follows: Level 1 - Observable inputs such as quoted prices in active markets; Level 2 - Inputs other than Level 1 prices, such as quoted prices for similar assets or liabilities, quoted prices in markets with insufficient volume or infrequent transactions (less active markets), or model-driven valuations in which all significant inputs are observable or can be derived principally from, or corroborated with, observable market data; and Level 3 - Unobservable inputs in which little or no market data exists, therefore requiring an entity to develop its own assumptions. Included in the Company’s cash and cash equivalents in the condensed consolidated balance sheet is its money market fund, which is measured at fair value on a recurring basis and categorized using the fair value hierarchy (in thousands):
|
|
|
|
|
|
|
September 30, 2024 |
|
|
|
Estimated Fair Value Level 1 |
|
Money market fund |
|
$ |
224,502 |
|
There were no Level 2 or Level 3 financial instruments measured at fair value on a recurring basis at September 30, 2024, and the Company did not have any financial instruments measured at fair value on a recurring basis at December 31, 2023. For information related to short-term investments, see Note 7, Held-to-Maturity Investments.
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v3.24.3
Note 9 - Share-Based Compensation
|
9 Months Ended |
Sep. 30, 2024 |
Share-Based Payment Arrangement [Abstract] |
|
Share-Based Compensation |
9.Share-Based Compensation On May 31, 2024, the Company held its 2024 Annual Meeting of Stockholders (Annual Meeting). At the Annual Meeting, the Company’s stockholders approved the Company’s Third Amended and Restated 2020 Equity Incentive Plan (the Amended and Restated Plan) which, among other things, (a) increased the aggregate number of shares of Common Stock authorized for issuance under the Amended and Restated Plan by 4,870,092 for a total of 12,500,000 shares of Common Stock, and (b) adjusted the “evergreen” provision included therein, such that the number of shares of Common Stock available for the grant of awards under the Amended and Restated Plan will automatically increase on January 1 of each year in an amount equal to 5% of the number of shares of Common Stock issued and outstanding on December 31 of the immediately preceding year (subject to adjustment in the event of stock splits and other similar events); provided, however, that the Company’s Board of Directors may act prior to January 1 of a given year to provide that there will be no increase in the share limit for such year or provide that the increase for such year will be a lesser number of shares of Common Stock. On August 14, 2024, the Company filed a Form S-8 to register 4,870,092 additional shares of Common Stock authorized for issuance under the Amended and Restated Plan as approved by stockholders at the Annual Meeting. The following table presents the share-based compensation expense recognized for all share-based compensation arrangements, excluding share-based compensation expense reported in Note 4, Discontinued Operations (in thousands):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended September 30, |
|
|
Nine Months Ended September 30, |
|
|
2024 |
|
|
2023 |
|
|
2024 |
|
|
2023 |
|
|
|
|
|
|
|
|
|
|
|
|
|
Research and development |
$ |
814 |
|
|
$ |
179 |
|
|
$ |
1,336 |
|
|
$ |
763 |
|
General and administrative |
|
1,138 |
|
|
|
239 |
|
|
|
1,825 |
|
|
|
1,687 |
|
Total share-based compensation |
$ |
1,952 |
|
|
$ |
418 |
|
|
$ |
3,161 |
|
|
$ |
2,450 |
|
|
X |
- DefinitionThe entire disclosure for share-based payment arrangement.
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v3.24.3
Note 10 - Commitments and Contingencies
|
9 Months Ended |
Sep. 30, 2024 |
Commitments and Contingencies Disclosure [Abstract] |
|
Commitments and Contingencies |
10.Commitments and Contingencies The Company has been in settlement negotiations with a representative for six stockholder plaintiff firms alleging the Company violated Delaware law in its preliminary proxy statement that was disseminated to stockholders in November 2022 for the Company’s annual meeting held in December 2022. Based on these settlement negotiations to date, the Company estimates that it will settle for no more than an aggregate of $0.2 million and, therefore, recorded an estimated liability of $0.2 million as of December 31, 2023. There was no change in the estimate as of September 30, 2024. This balance is included in accrued expenses on the unaudited condensed consolidated balance sheets.
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v3.24.3
Note 11 - Related Parties
|
9 Months Ended |
Sep. 30, 2024 |
Related Party Transactions [Abstract] |
|
Related Party Transactions Disclosure [Text Block] |
In connection with the Lantheus Investment Agreement entered into with Lantheus on January 8, 2024, the Company agreed to sell and issue the Lantheus Shares. The number of Lantheus Shares sold was 5,634,235, representing 19.99% of the outstanding shares of Common Stock as of January 8, 2024. On January 8, 2024, the Company entered into the Progenics APA with Progenics, an affiliate of Lantheus, for a purchase price of $8.0 million. On March 1, 2024, the Company closed on the transactions contemplated by the Progenics APA. On March 4, 2024, the Company entered into the March 2024 Investment Agreement in which the Company agreed to issue and sell 9,200,998 shares of Common Stock. Lantheus, a significant stockholder of the Company, purchased part of the shares issued to increase their ownership percentage to approximately 19.9% in the Company following the closing of the March 2024 Investment Agreement on March 6, 2024. For additional information regarding the Lantheus Investment Agreement, the Progenics APA and the March 2024 Investment Agreement, see Note 3, Investments and Agreements. On August 8, 2024, the Company entered into an access and license agreement with Lantheus. For additional information, see Note 12, Leases.
|
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v3.24.3
Note 12 - Leases
|
9 Months Ended |
Sep. 30, 2024 |
Leases [Abstract] |
|
Leases |
The Company accounts for its leases under ASC 842, Leases. Effective April 1, 2024, the Company entered into a lease with the Board of Regents, State of Iowa, for lab and office space at the BioVentures Center. The lease terminates in March 2026. Upon entering into this lease, the Company recognized a right-of-use asset and lease liability of approximately $1.1 million on the balance sheet based upon the present value of the future base payments discounted at an 8% discount rate using the rate of interest that the Company would have to pay to borrow on a collateralized basis over a similar term an amount equal to the lease payments in a similar economic environment as the lease does not provide an implicit discount rate. The Company acquired a lease from Progenics, an affiliate of Lantheus, for a production facility in Somerset, New Jersey effective on March 1, 2024 (see Note 3, Investments and Agreements, in this Form 10-Q). The lease terminates on November 29, 2028. Upon entering into this lease, the Company recognized a right-of-use asset and lease liability of approximately $0.3 million on the balance sheet based upon the present value of the future base payments discounted at an 8% discount rate using the rate of interest that the Company would have to pay to borrow on a collateralized basis over a similar term an amount equal to the lease payments in a similar economic environment as the lease does not provide an implicit discount rate. On August 8, 2024, the Company assumed a lease from Progenics for office space in Somerset, New Jersey (Office). The lease terminates on November 30, 2028. Upon entering into this lease, the Company recognized a right-of-use asset and lease liability of approximately $0.6 million on the balance sheet based upon the present value of the future base payments discounted at an 8% discount rate using the rate of interest that the Company would have to pay to borrow on a collateralized basis over a similar term an amount equal to the lease payments in a similar economic environment as the lease does not provide an implicit discount rate. Upon assuming the lease, the Company entered into a license and access agreement with Lantheus, which provides access to both dedicated and shared space of the Office (Access Agreement). There is no renewal option, and the termination options are available only for material breaches. In consideration of the Access Agreement, Lantheus agreed to pay base rent and associated costs through December 2024 directly to the landlord. The base rent through December 2024 is less than $0.1 million (Prepaid Rent). Pursuant to ASC 842, Leases, the Access Agreement is a sublease in which the Company is a sublessor and Lantheus is a sublessee. The Company will amortize the Prepaid Rent over the entire lease term of 52 months. On July 1, 2023, the Company entered into a lease with Unico Properties LLC for office space in Seattle, Washington that terminates in October 2028. Upon entering into this lease, the Company recognized a right-of-use asset and lease liability of approximately $0.8 million on the balance sheet based upon the present value of the future base payments discounted at an 8% discount rate using the rate of interest that the Company would have to pay to borrow on a collateralized basis over a similar term an amount equal to the lease payments in a similar economic environment as the lease does not provide an implicit discount rate. The weighted average remaining term and discount rate for the Company’s operating leases as of September 30, 2024 was 3.2 years and 8%, respectively. The Company’s operating lease expense was $0.3 million and $0.5 million for the three and nine months ended September 30, 2024, respectively, and $0.2 million and $0.4 million for the three and nine months ended September 30, 2023. The following table presents the future operating lease payments and lease liability included on the condensed consolidated balance sheet related to the Company’s operating leases as of September 30, 2024 (in thousands):
|
|
|
|
|
Year Ending December 31, |
|
|
|
2024 (remaining three months) |
|
$ |
245 |
|
2025 |
|
|
1,112 |
|
2026 |
|
|
647 |
|
2027 |
|
|
493 |
|
2028 |
|
|
443 |
|
Total |
|
|
2,940 |
|
Less: imputed interest |
|
|
(361 |
) |
Total lease liability |
|
|
2,579 |
|
Less: current portion |
|
|
(903 |
) |
Noncurrent lease liability |
|
$ |
1,676 |
|
Asset Retirement Obligation The Company had an asset retirement obligation (ARO) associated with the facility it leased in Richland, Washington. This lease is included in the GT Medical APA and was assigned to GT Medical upon the GT Medical Closing, which occurred on April 12, 2024. As such, this liability is no longer reported as an ARO in the Company’s condensed consolidated financial statements as of September 30, 2024 and December 31, 2023. However, the Company maintains the estimated liability in its condensed consolidated financial statements related to hazardous waste removal. The estimated liability at each of September 30, 2024 and December 31, 2023 was $0.5 million and is included within the accounts payable and accrued expenses in the condensed consolidated balance sheets.
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- DefinitionThe entire disclosure for operating leases of lessee. Includes, but is not limited to, description of operating lease and maturity analysis of operating lease liability.
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v3.24.3
Note 13 - Notes Payable
|
9 Months Ended |
Sep. 30, 2024 |
Debt Disclosure [Abstract] |
|
Notes Payable |
The Company assumed two notes payable effective upon the closing of the Merger with Viewpoint on February 3, 2023. On July 19, 2019, Viewpoint entered into a promissory note agreement with the Iowa Economic Development Authority (IEDA) for $0.1 million at 3% interest rate to be paid over 36 monthly payments beginning on the first day of the first month following Viewpoint closing on a $1.0 million equity fundraising round. Final payment was paid in September 2023. The loan was granted as a form of financial assistance to Viewpoint from IEDA. On December 29, 2022, Viewpoint obtained a promissory note in the amount of $1.7 million for the purpose of purchasing land and a building in Coralville, Iowa. The note bears interest at 6.15% per annum and is collateralized by the property. The note requires monthly principal and interest payments, and a balloon payment of approximately $1.5 million is due on December 29, 2027. The following table presents the current and long-term portions of the note payable (in thousands):
|
|
|
|
|
|
|
|
|
|
|
September 30, |
|
|
December 31, |
|
|
|
2024 |
|
|
2023 |
|
|
|
|
|
|
|
|
Note payable |
|
$ |
1,689 |
|
|
$ |
1,725 |
|
Less: current portion |
|
|
(51 |
) |
|
|
(49 |
) |
Note payable, long-term portion |
|
$ |
1,638 |
|
|
$ |
1,676 |
|
The following table presents the future principal payments included on the condensed consolidated balance sheet related to the Company’s note payable as of September 30, 2024 (in thousands):
|
|
|
|
|
Years ending December 31: |
|
|
|
2024 (remaining three months) |
|
$ |
13 |
|
2025 |
|
|
52 |
|
2026 |
|
|
55 |
|
2027 |
|
|
1,569 |
|
Total |
|
$ |
1,689 |
|
|
X |
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v3.24.3
Note 14 - Merger
|
9 Months Ended |
Sep. 30, 2024 |
Business Combinations [Abstract] |
|
Merger |
On February 3, 2023, the Company acquired 100% of the issued and outstanding equity and voting shares of Viewpoint Molecular Targeting, Inc. in exchange for 13,654,507 shares of Common Stock with a fair value of $54.6 million based on the closing market price of $4.00 per share on the acquisition date. At the closing of the Merger, the Company forgave the note receivable entered into in November 2022 and the associated accrued interest with Viewpoint that was included in the note receivable. The total amount forgiven was $6.2 million, representing the $6.0 million loan and $0.2 million accrued interest. The Company also assumed all of Viewpoint’s outstanding stock options and warrants as of the Merger date. The Merger was completed to provide the Company with a new isotope in a larger market. The Company accounted for the transaction as a business combination in accordance ASC 805, Business Combinations. The Company has performed an allocation of the purchase price paid for the assets acquired and the liabilities assumed with the assistance of an independent valuation firm. The Viewpoint purchase price consideration and allocation to net assets acquired is presented below (in thousands except for share price):
|
|
|
|
|
Fair value of consideration transferred |
|
|
|
Perspective Therapeutics common stock issued (13,654,507 x $4.00) |
|
$ |
54,618 |
|
Assumption of Viewpoint stock options and warrants at fair value |
|
|
7,836 |
|
Note receivable and interest from Viewpoint forgiven |
|
|
6,171 |
|
Total fair value of consideration transferred |
|
$ |
68,625 |
|
|
|
|
|
|
Recognized amounts of identifiable net assets acquired |
|
|
|
Assets acquired |
|
|
|
Cash and cash equivalents |
|
$ |
2,699 |
|
Grants receivable |
|
|
95 |
|
Prepaid expenses |
|
|
396 |
|
Property and equipment |
|
|
5,050 |
|
Right-of-use asset |
|
|
10 |
|
Intangible assets, in-process research and development |
|
|
50,000 |
|
Other assets |
|
|
316 |
|
Total assets acquired |
|
|
58,566 |
|
|
|
|
|
Liabilities assumed |
|
|
|
Accounts payable and accrued expenses |
|
|
2,968 |
|
Lease liability |
|
|
10 |
|
Accrued payroll and related taxes |
|
|
1,642 |
|
Accrued vacation |
|
|
333 |
|
Notes payable |
|
|
1,807 |
|
Deferred tax liability |
|
|
7,243 |
|
Total liabilities assumed |
|
|
14,003 |
|
|
|
|
|
Net assets acquired, excluding goodwill |
|
|
44,563 |
|
Total purchase price consideration |
|
|
68,625 |
|
|
|
|
|
Goodwill |
|
$ |
24,062 |
|
Goodwill is calculated as the difference between the acquisition date fair value of the consideration and the values assigned to the assets acquired and liabilities assumed. Goodwill is not amortized and is not currently assumed to be deductible for tax purposes. The goodwill is attributable to the workforce of the acquired business and the synergies expected to arise from the acquisition of Viewpoint. Upon completion of the Merger, Viewpoint became a wholly owned subsidiary of the Company and its results of operations have been included in the Company’s condensed consolidated financial statements. Since the closing date, Viewpoint’s results of operations have been reported in the Company’s condensed consolidated financial statements and include grant revenue of approximately $0.4 million and $0.3 million, respectively, and operating loss of $18.6 million and $9.8 million, respectively, for the three months ended September 30, 2024 and 2023, and grant revenue of approximately $1.2 million and $1.1 million, respectively, and operating loss of $45.9 million and $29.3 million, respectively, for the nine months ended September 30, 2024 and 2023.
|
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- DefinitionThe entire disclosure for a business combination (or series of individually immaterial business combinations) completed during the period, including background, timing, and recognized assets and liabilities. The disclosure may include leverage buyout transactions (as applicable).
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v3.24.3
Disclosure - Note 1 - Basis of Presentation and Summary of Significant Accounting Policies (Policies)
|
9 Months Ended |
Sep. 30, 2024 |
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] |
|
Reclassifications |
Reclassifications In addition to the discontinued operations discussed above, during the first quarter of 2024, the Company made certain reclassifications to prior period amounts in the condensed consolidated financial statements and accompanying notes to conform to the current period presentation. The reclassification of these items had no impact on net loss, financial position or cash flows in the current or prior periods. Specifically, accrued payroll and related taxes and accrued vacation were combined to create accrued personnel, and accrued protocol expense and accrued waste disposal were included in accounts payable and accrued expenses, all of which are presented on the condensed consolidated balance sheets and condensed consolidated statement of cash flows.
|
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- DefinitionLine items represent financial concepts included in a table. These concepts are used to disclose reportable information associated with domain members defined in one or many axes to the table.
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v3.24.3
Note 4 - Discontinued Operations (Tables)
|
9 Months Ended |
Sep. 30, 2024 |
Discontinued Operations and Disposal Groups [Abstract] |
|
Schedule of Discontinued Operations |
In accordance with ASC 205-20, Presentation of Financial Statements – Discontinued Operations, the following table presents the major classes of assets and liabilities of discontinued operations of the Business reported in the condensed consolidated balance sheets and prior year amounts have been reclassified.
|
|
|
|
|
|
|
|
|
|
|
September 30, 2024 |
|
|
December 31, 2023 |
|
(in thousands) |
|
|
|
|
|
|
Assets held for sale of discontinued operations, current |
|
|
|
|
|
|
Inventory |
|
$ |
- |
|
|
$ |
3,148 |
|
Prepaid expenses and other current assets |
|
|
- |
|
|
|
169 |
|
Property and equipment, net |
|
|
- |
|
|
|
1,263 |
|
Right-of-use asset, net |
|
|
- |
|
|
|
676 |
|
Other assets, net |
|
|
- |
|
|
|
45 |
|
Total current assets held for sale of discontinued operations |
|
$ |
- |
|
|
$ |
5,301 |
|
|
|
|
|
|
|
|
Liabilities held for sale of discontinued operations, current |
|
|
|
|
|
|
Lease liability |
|
$ |
- |
|
|
$ |
677 |
|
Asset retirement obligation |
|
|
- |
|
|
|
225 |
|
Loss recognized on classification as held for sale |
|
|
- |
|
|
|
4,170 |
|
Total current liabilities of discontinued operations |
|
$ |
- |
|
|
$ |
5,072 |
|
The following table presents the components of discontinued operations in relation to the Business reported in the unaudited condensed consolidated statements of operations (in thousands):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended September 30, |
|
|
Nine Months Ended September 30, |
|
|
|
2024 |
|
|
2023 |
|
|
2024 |
|
|
2023 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Sales, net |
|
$ |
- |
|
|
$ |
1,909 |
|
|
$ |
2,178 |
|
|
$ |
5,239 |
|
Cost of sales |
|
|
- |
|
|
|
1,447 |
|
|
|
1,564 |
|
|
|
4,863 |
|
Gross profit |
|
|
- |
|
|
|
462 |
|
|
|
614 |
|
|
|
376 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Operating expenses: |
|
|
|
|
|
|
|
|
|
|
|
|
Research and development |
|
|
- |
|
|
|
169 |
|
|
|
69 |
|
|
|
1,000 |
|
Sales and marketing |
|
|
- |
|
|
|
855 |
|
|
|
941 |
|
|
|
2,578 |
|
General and administrative |
|
|
- |
|
|
|
222 |
|
|
|
494 |
|
|
|
668 |
|
Total operating expenses |
|
|
- |
|
|
|
1,246 |
|
|
|
1,504 |
|
|
|
4,246 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total loss from discontinued operations |
|
$ |
- |
|
|
$ |
(784 |
) |
|
$ |
(890 |
) |
|
$ |
(3,870 |
) |
Certain amounts included in the unaudited condensed consolidated statements of cash flows related to the discontinued operations are as follows (in thousands):
|
|
|
|
|
|
|
|
|
|
|
Nine Months Ended September 30, |
|
|
|
2024 |
|
|
2023 |
|
|
|
|
|
|
|
|
Depreciation |
|
$ |
- |
|
|
$ |
171 |
|
Amortization |
|
|
- |
|
|
|
27 |
|
Write-off of inventory associated with discontinued product |
|
|
- |
|
|
|
298 |
|
Share-based compensation |
|
|
166 |
|
|
|
568 |
|
Additions to property and equipment |
|
|
- |
|
|
|
287 |
|
|
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v3.24.3
Note 5 - Property and Equipment (Tables)
|
9 Months Ended |
Sep. 30, 2024 |
Property, Plant and Equipment [Abstract] |
|
Summary of Property and Equipment |
The Company’s property and equipment consisted of the following as of:
|
|
|
|
|
|
|
|
|
|
|
September 30, 2024 |
|
|
December 31, 2023 |
|
|
|
(in thousands) |
|
Building |
|
$ |
1,770 |
|
|
$ |
1,770 |
|
Land |
|
|
1,283 |
|
|
|
1,283 |
|
Equipment |
|
|
10,601 |
|
|
|
2,683 |
|
Leasehold improvements |
|
|
3,497 |
|
|
|
179 |
|
Other1 |
|
|
28,895 |
|
|
|
330 |
|
Property and equipment |
|
|
46,046 |
|
|
|
6,245 |
|
Less accumulated depreciation |
|
|
(2,254 |
) |
|
|
(669 |
) |
Property and equipment, net |
|
$ |
43,792 |
|
|
$ |
5,576 |
|
1.Property and equipment not placed in service are items that meet the capitalization threshold, or which management believes will meet the threshold at the time of completion and which have yet to be placed into service as of the date of the balance sheets and, therefore, no depreciation expense has been recognized.
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v3.24.3
Note 6 - Goodwill and Other Intangible Assets (Tables)
|
9 Months Ended |
Sep. 30, 2024 |
Goodwill and Intangible Assets Disclosure [Abstract] |
|
Summary of Components of Other Intangible Assets |
The following table summarizes the components of the Company’s other intangible assets (in thousands):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
September 30, 2024 |
|
|
|
Cost |
|
|
Accumulated Amortization |
|
|
Net Carrying Value |
|
Indefinite-lived intangible assets |
|
|
|
|
|
|
|
|
|
In-process research and development |
|
$ |
50,000 |
|
|
$ |
- |
|
|
$ |
50,000 |
|
Total |
|
$ |
50,000 |
|
|
$ |
- |
|
|
$ |
50,000 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
December 31, 2023 |
|
|
|
Cost |
|
|
Accumulated Amortization |
|
|
Net Carrying Value |
|
Indefinite-lived intangible assets |
|
|
|
|
|
|
|
|
|
In-process research and development |
|
$ |
50,000 |
|
|
$ |
- |
|
|
$ |
50,000 |
|
Total |
|
$ |
50,000 |
|
|
$ |
- |
|
|
$ |
50,000 |
|
|
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- DefinitionTabular disclosure of information about investment in debt security measured at amortized cost (held-to-maturity).
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v3.24.3
Note 9 - Share-Based Compensation (Tables)
|
9 Months Ended |
Sep. 30, 2024 |
Share-Based Payment Arrangement [Abstract] |
|
Summary of Share-based Compensation Expense Recognized for Share-based Compensation Arrangements Excluding Share-based Compensation Expense |
The following table presents the share-based compensation expense recognized for all share-based compensation arrangements, excluding share-based compensation expense reported in Note 4, Discontinued Operations (in thousands):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended September 30, |
|
|
Nine Months Ended September 30, |
|
|
2024 |
|
|
2023 |
|
|
2024 |
|
|
2023 |
|
|
|
|
|
|
|
|
|
|
|
|
|
Research and development |
$ |
814 |
|
|
$ |
179 |
|
|
$ |
1,336 |
|
|
$ |
763 |
|
General and administrative |
|
1,138 |
|
|
|
239 |
|
|
|
1,825 |
|
|
|
1,687 |
|
Total share-based compensation |
$ |
1,952 |
|
|
$ |
418 |
|
|
$ |
3,161 |
|
|
$ |
2,450 |
|
|
X |
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v3.24.3
Note 12 - Leases (Tables)
|
9 Months Ended |
Sep. 30, 2024 |
Notes Tables |
|
Summary of Future Operating Lease Payments and Lease Liability |
The following table presents the future operating lease payments and lease liability included on the condensed consolidated balance sheet related to the Company’s operating leases as of September 30, 2024 (in thousands):
|
|
|
|
|
Year Ending December 31, |
|
|
|
2024 (remaining three months) |
|
$ |
245 |
|
2025 |
|
|
1,112 |
|
2026 |
|
|
647 |
|
2027 |
|
|
493 |
|
2028 |
|
|
443 |
|
Total |
|
|
2,940 |
|
Less: imputed interest |
|
|
(361 |
) |
Total lease liability |
|
|
2,579 |
|
Less: current portion |
|
|
(903 |
) |
Noncurrent lease liability |
|
$ |
1,676 |
|
|
X |
- DefinitionTabular disclosure of undiscounted cash flows of lessee's operating lease liability. Includes, but is not limited to, reconciliation of undiscounted cash flows to operating lease liability recognized in statement of financial position.
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v3.24.3
Note 13 - Notes Payable (Tables)
|
9 Months Ended |
Sep. 30, 2024 |
Debt Disclosure [Abstract] |
|
Summary of Note Payable |
The following table presents the current and long-term portions of the note payable (in thousands):
|
|
|
|
|
|
|
|
|
|
|
September 30, |
|
|
December 31, |
|
|
|
2024 |
|
|
2023 |
|
|
|
|
|
|
|
|
Note payable |
|
$ |
1,689 |
|
|
$ |
1,725 |
|
Less: current portion |
|
|
(51 |
) |
|
|
(49 |
) |
Note payable, long-term portion |
|
$ |
1,638 |
|
|
$ |
1,676 |
|
|
Summary of Maturity of Note Payable |
The following table presents the future principal payments included on the condensed consolidated balance sheet related to the Company’s note payable as of September 30, 2024 (in thousands):
|
|
|
|
|
Years ending December 31: |
|
|
|
2024 (remaining three months) |
|
$ |
13 |
|
2025 |
|
|
52 |
|
2026 |
|
|
55 |
|
2027 |
|
|
1,569 |
|
Total |
|
$ |
1,689 |
|
|
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v3.24.3
Note 14 - Merger (Tables)
|
9 Months Ended |
Sep. 30, 2024 |
Business Combinations [Abstract] |
|
Summary of Estimated Purchase Consideration |
The Viewpoint purchase price consideration and allocation to net assets acquired is presented below (in thousands except for share price):
|
|
|
|
|
Fair value of consideration transferred |
|
|
|
Perspective Therapeutics common stock issued (13,654,507 x $4.00) |
|
$ |
54,618 |
|
Assumption of Viewpoint stock options and warrants at fair value |
|
|
7,836 |
|
Note receivable and interest from Viewpoint forgiven |
|
|
6,171 |
|
Total fair value of consideration transferred |
|
$ |
68,625 |
|
|
Summary of Preliminary Purchase Price Allocation |
|
|
|
|
|
Recognized amounts of identifiable net assets acquired |
|
|
|
Assets acquired |
|
|
|
Cash and cash equivalents |
|
$ |
2,699 |
|
Grants receivable |
|
|
95 |
|
Prepaid expenses |
|
|
396 |
|
Property and equipment |
|
|
5,050 |
|
Right-of-use asset |
|
|
10 |
|
Intangible assets, in-process research and development |
|
|
50,000 |
|
Other assets |
|
|
316 |
|
Total assets acquired |
|
|
58,566 |
|
|
|
|
|
Liabilities assumed |
|
|
|
Accounts payable and accrued expenses |
|
|
2,968 |
|
Lease liability |
|
|
10 |
|
Accrued payroll and related taxes |
|
|
1,642 |
|
Accrued vacation |
|
|
333 |
|
Notes payable |
|
|
1,807 |
|
Deferred tax liability |
|
|
7,243 |
|
Total liabilities assumed |
|
|
14,003 |
|
|
|
|
|
Net assets acquired, excluding goodwill |
|
|
44,563 |
|
Total purchase price consideration |
|
|
68,625 |
|
|
|
|
|
Goodwill |
|
$ |
24,062 |
|
|
X |
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v3.24.3
Note 1 - Basis of Presentation and Summary of Significant Accounting Policies (Details Textual) $ / shares in Units, $ in Thousands |
|
|
|
|
1 Months Ended |
3 Months Ended |
9 Months Ended |
12 Months Ended |
Jun. 14, 2024 |
Apr. 12, 2024
$ / shares
shares
|
Apr. 11, 2024
USD ($)
$ / shares
shares
|
Feb. 03, 2023
$ / shares
shares
|
Dec. 31, 2023
USD ($)
$ / shares
shares
|
Sep. 30, 2024
USD ($)
$ / shares
|
Sep. 30, 2023
USD ($)
|
Sep. 30, 2024
USD ($)
$ / shares
|
Sep. 30, 2023
USD ($)
|
Dec. 31, 2024 |
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] |
|
|
|
|
|
|
|
|
|
|
Common stock, par value | $ / shares |
|
|
|
|
$ 0.001
|
$ 0.001
|
|
$ 0.001
|
|
|
Reverse stock split, ratio |
0.1
|
|
|
|
|
|
|
|
|
|
Cash, cash equivalents and short-term investments | $ |
|
|
|
|
|
$ 267,800
|
|
$ 267,800
|
|
|
Accumulated deficit | $ |
|
|
|
|
$ (152,440)
|
(191,550)
|
|
(191,550)
|
|
|
Loss on equity method investment | $ |
|
|
|
|
|
$ 0
|
$ 12
|
$ 6
|
$ 12
|
|
Forecast [Member] |
|
|
|
|
|
|
|
|
|
|
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] |
|
|
|
|
|
|
|
|
|
|
Effective income tax rate |
|
|
|
|
|
|
|
|
|
0.00%
|
GT Medical Technologies, Inc. [Member] |
|
|
|
|
|
|
|
|
|
|
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] |
|
|
|
|
|
|
|
|
|
|
Stock issued during period, shares | shares |
|
279,516
|
|
|
|
|
|
|
|
|
Common stock, par value | $ / shares |
|
$ 0.0001
|
|
|
|
|
|
|
|
|
Percentage of issued and outstanding capital stock |
|
0.50%
|
|
|
|
|
|
|
|
|
Oppenheimer & Co [Member] |
|
|
|
|
|
|
|
|
|
|
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] |
|
|
|
|
|
|
|
|
|
|
Stock issued during period, shares | shares |
|
|
3,535,246
|
|
123,882
|
|
|
|
|
|
Stock purchase price per share | $ / shares |
|
|
$ 14
|
|
$ 3.03
|
|
|
|
|
|
Proceeds from issuance of common stock | $ |
|
|
$ 49,500
|
|
$ 400
|
|
|
|
|
|
Viewpoint Molecular Targeting, Inc. [Member] |
|
|
|
|
|
|
|
|
|
|
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] |
|
|
|
|
|
|
|
|
|
|
Common stock issued pursuant to merger, Shares | shares |
|
|
|
13,654,507
|
|
|
|
|
|
|
Percentage of fully-diluted outstanding capital stock |
|
|
|
49.00%
|
|
|
|
|
|
|
Common stock, par value | $ / shares |
|
|
|
$ 0.001
|
|
|
|
|
|
|
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v3.24.3
Note 2 - Loss Per Share (Details Textual) - Viewpoint Molecular Targeting, Inc. [Member]
|
Feb. 03, 2023
$ / shares
shares
|
Earnings Per Share, Basic, by Common Class, Including Two Class Method [Line Items] |
|
Warrants to purchase shares of common stock | shares |
338,709
|
Warrant exercise price per share |
$ 2.7
|
Options to purchase shares of common stock | shares |
2,426,342
|
Minimum [Member] |
|
Earnings Per Share, Basic, by Common Class, Including Two Class Method [Line Items] |
|
Options exercise price per share |
$ 1.3
|
Maximum [Member] |
|
Earnings Per Share, Basic, by Common Class, Including Two Class Method [Line Items] |
|
Options exercise price per share |
$ 3
|
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v3.24.3
Note 3 - Investments and Agreements (Details Textual) - USD ($)
|
|
|
|
|
|
1 Months Ended |
3 Months Ended |
|
|
|
|
May 24, 2024 |
Apr. 11, 2024 |
Mar. 04, 2024 |
Jan. 17, 2024 |
Jan. 08, 2024 |
Dec. 31, 2023 |
Jun. 30, 2024 |
Mar. 31, 2024 |
Sep. 30, 2024 |
Aug. 13, 2024 |
Dec. 14, 2023 |
Nov. 17, 2023 |
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] |
|
|
|
|
|
|
|
|
|
|
|
|
|
Common stock, par value |
|
|
|
|
|
|
$ 0.001
|
|
|
$ 0.001
|
|
|
|
Maximum amount of securities offer and sell |
|
|
|
|
|
|
|
|
|
|
|
$ 200,000,000
|
|
January 2024 Pre-funded Warrants [Member] |
|
|
|
|
|
|
|
|
|
|
|
|
|
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] |
|
|
|
|
|
|
|
|
|
|
|
|
|
Warrants to purchase shares of common stock |
|
|
|
|
3,008,694
|
|
|
|
|
|
|
|
|
Warrant exercise price per share |
|
|
|
|
$ 3.69
|
|
|
|
|
|
|
|
|
Percentage of ownership considered for warrant exercise |
|
|
|
|
4.99%
|
|
|
|
|
|
|
|
|
Maximum increase or decrease in ownership percentage |
|
|
|
|
19.99%
|
|
|
|
|
|
|
|
|
2024 At-the-Market (ATM) Agreement [Member] |
|
|
|
|
|
|
|
|
|
|
|
|
|
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] |
|
|
|
|
|
|
|
|
|
|
|
|
|
Agent commission fee as a percentage of gross sales price |
|
|
|
|
|
|
|
|
|
|
3.00%
|
|
|
2024 At-the-Market (ATM) Agreement [Member] | Common Stock [Member] |
|
|
|
|
|
|
|
|
|
|
|
|
|
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] |
|
|
|
|
|
|
|
|
|
|
|
|
|
Maximum amount of securities offer and sell |
|
|
|
|
|
|
|
|
|
|
$ 250,000,000
|
|
|
March 2024 Private Placement [Member] |
|
|
|
|
|
|
|
|
|
|
|
|
|
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] |
|
|
|
|
|
|
|
|
|
|
|
|
|
Stock issued during period, shares |
|
|
|
9,200,998
|
|
|
|
|
|
|
|
|
|
Stock purchase price per share |
|
|
|
$ 9.5
|
|
|
|
|
|
|
|
|
|
Proceeds from issuance of common stock |
|
|
|
$ 87,400,000
|
|
|
|
|
|
|
|
|
|
Placement agents cash fee, percentage |
|
|
|
5.85%
|
|
|
|
|
|
|
|
|
|
Lantheus Investment Agreement |
|
|
|
|
|
|
|
|
|
|
|
|
|
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] |
|
|
|
|
|
|
|
|
|
|
|
|
|
Stock issued during period, shares |
|
|
|
|
|
5,634,235
|
|
|
|
|
|
|
|
Investment agreement, contingent amount of gross proceeds raised |
|
|
|
|
|
$ 50,000,000
|
|
|
|
|
|
|
|
Percent of outstanding shares |
|
|
|
|
|
19.99%
|
|
|
|
|
|
|
|
Asset purchase price in cash |
|
|
|
|
|
$ 8,000,000
|
|
|
|
|
|
|
|
Lantheus Investment Agreement | Common Stock [Member] |
|
|
|
|
|
|
|
|
|
|
|
|
|
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] |
|
|
|
|
|
|
|
|
|
|
|
|
|
Stock issued during period, shares |
[1],[2] |
|
|
|
|
|
|
|
5,634,235
|
|
|
|
|
Lantheus Investment Agreement | Option Agreement [Member] |
|
|
|
|
|
|
|
|
|
|
|
|
|
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] |
|
|
|
|
|
|
|
|
|
|
|
|
|
Percent of outstanding shares |
|
|
|
|
|
|
|
|
19.90%
|
|
|
|
|
One-time payment received for rights granted |
|
|
|
|
|
28,000,000
|
|
|
|
|
|
|
|
Repayment provisions |
|
|
|
|
|
$ 0
|
|
|
|
|
|
|
|
Public Offering [Member] |
|
|
|
|
|
|
|
|
|
|
|
|
|
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] |
|
|
|
|
|
|
|
|
|
|
|
|
|
Stock issued during period, shares |
|
|
|
|
13,207,521
|
|
|
|
|
|
|
|
|
Sale of stock, price per share |
|
|
|
|
$ 3.7
|
|
|
|
|
|
|
|
|
Shares and warrants, price difference per share |
|
|
|
|
$ 0.01
|
|
|
|
|
|
|
|
|
Gross proceeds from public offering |
|
|
|
|
$ 69,000,000
|
|
|
|
|
|
|
|
|
Public Offering [Member] | Common Stock [Member] |
|
|
|
|
|
|
|
|
|
|
|
|
|
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] |
|
|
|
|
|
|
|
|
|
|
|
|
|
Stock issued during period, shares |
[1],[2] |
|
|
|
|
|
|
|
15,639,954
|
|
|
|
|
Over-Allotment Option [Member] |
|
|
|
|
|
|
|
|
|
|
|
|
|
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] |
|
|
|
|
|
|
|
|
|
|
|
|
|
Stock issued during period, shares |
|
|
|
|
2,432,432
|
|
|
|
|
|
|
|
|
Registered Offering [Member] | Common Stock [Member] |
|
|
|
|
|
|
|
|
|
|
|
|
|
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] |
|
|
|
|
|
|
|
|
|
|
|
|
|
Stock issued during period, shares |
[1],[2] |
|
|
|
|
|
|
5,151,588
|
|
|
|
|
|
Oppenheimer & Co [Member] |
|
|
|
|
|
|
|
|
|
|
|
|
|
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] |
|
|
|
|
|
|
|
|
|
|
|
|
|
Stock issued during period, shares |
|
|
3,535,246
|
|
|
|
123,882
|
|
|
|
|
|
|
Stock purchase price per share |
|
|
$ 14
|
|
|
|
$ 3.03
|
|
|
|
|
|
|
Proceeds from issuance of common stock |
|
|
$ 49,500,000
|
|
|
|
$ 400,000
|
|
|
|
|
|
|
Maximum amount of securities offer and sale |
|
|
|
|
|
|
|
|
|
|
|
|
$ 50,000,000
|
BofA Securities, Inc [Member] | Underwriting Agreement [Member] | May 2024 Pre-funded Warrants [Member] |
|
|
|
|
|
|
|
|
|
|
|
|
|
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] |
|
|
|
|
|
|
|
|
|
|
|
|
|
Warrants to purchase shares of common stock |
|
146,425
|
|
|
|
|
|
|
|
|
|
|
|
Warrant exercise price per share |
|
$ 15.09
|
|
|
|
|
|
|
|
|
|
|
|
Percentage of ownership considered for warrant exercise |
|
4.99%
|
|
|
|
|
|
|
|
|
|
|
|
Percentage of ownership considered for warrant exercise |
|
9.99%
|
|
|
|
|
|
|
|
|
|
|
|
Maximum increase or decrease in ownership percentage |
|
19.99%
|
|
|
|
|
|
|
|
|
|
|
|
BofA Securities, Inc [Member] | Registered Offering [Member] | Underwriting Agreement [Member] |
|
|
|
|
|
|
|
|
|
|
|
|
|
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] |
|
|
|
|
|
|
|
|
|
|
|
|
|
Stock issued during period, shares |
|
5,151,588
|
|
|
|
|
|
|
|
|
|
|
|
Sale of stock, price per share |
|
$ 15.1
|
|
|
|
|
|
|
|
|
|
|
|
Shares and warrants, price difference per share |
|
$ 0.01
|
|
|
|
|
|
|
|
|
|
|
|
Gross proceeds from public offering |
|
$ 80,000,000
|
|
|
|
|
|
|
|
|
|
|
|
|
|
X |
- DefinitionRepresents the amount of gross proceeds raised as part of an investment agreement.
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v3.24.3
Note 4 - Discontinued Operations (Details Textual) - USD ($)
|
|
3 Months Ended |
9 Months Ended |
|
Apr. 12, 2024 |
Sep. 30, 2024 |
Sep. 30, 2023 |
Sep. 30, 2024 |
Sep. 30, 2023 |
Dec. 31, 2023 |
Income Statement, Balance Sheet and Additional Disclosures by Disposal Groups, Including Discontinued Operations [Line Items] |
|
|
|
|
|
|
Common stock, par value |
|
$ 0.001
|
|
$ 0.001
|
|
$ 0.001
|
Discontinued operations, Provision (benefit) for income taxes |
|
$ 0
|
$ 0
|
$ 0
|
$ 0
|
|
GT Medical Technologies, Inc. [Member] |
|
|
|
|
|
|
Income Statement, Balance Sheet and Additional Disclosures by Disposal Groups, Including Discontinued Operations [Line Items] |
|
|
|
|
|
|
Stock issued during period, shares |
279,516
|
|
|
|
|
|
Common stock, par value |
$ 0.0001
|
|
|
|
|
|
Percentage of issued and outstanding capital stock |
0.50%
|
|
|
|
|
|
Royalty agreement percentage of net sales receivable |
0.50%
|
|
|
|
|
|
GT Medical Technologies, Inc. [Member] | Net Sales of $10.0 Million or Less [Member] |
|
|
|
|
|
|
Income Statement, Balance Sheet and Additional Disclosures by Disposal Groups, Including Discontinued Operations [Line Items] |
|
|
|
|
|
|
Royalty agreement percentage of net sales receivable |
3.00%
|
|
|
|
|
|
GT Medical Technologies, Inc. [Member] | Net Sales Between $10.0 and 15.0 Million [Member] |
|
|
|
|
|
|
Income Statement, Balance Sheet and Additional Disclosures by Disposal Groups, Including Discontinued Operations [Line Items] |
|
|
|
|
|
|
Royalty agreement percentage of net sales receivable |
4.00%
|
|
|
|
|
|
GT Medical Technologies, Inc. [Member] | Net Sales Greater Than $15.0 Million [Member] |
|
|
|
|
|
|
Income Statement, Balance Sheet and Additional Disclosures by Disposal Groups, Including Discontinued Operations [Line Items] |
|
|
|
|
|
|
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5.00%
|
|
|
|
|
|
GT Medical Technologies, Inc. [Member] | GT Medical Stock [Member] |
|
|
|
|
|
|
Income Statement, Balance Sheet and Additional Disclosures by Disposal Groups, Including Discontinued Operations [Line Items] |
|
|
|
|
|
|
Estimated fair value |
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|
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|
|
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v3.24.3
Note 4 - Discontinued Operations - Schedule of Discontinued Operations (Details) - USD ($) $ in Thousands |
3 Months Ended |
9 Months Ended |
|
Sep. 30, 2024 |
Sep. 30, 2023 |
Sep. 30, 2024 |
Sep. 30, 2023 |
Dec. 31, 2023 |
Assets held for sale of discontinued operations, current |
|
|
|
|
|
Total current assets held for sale of discontinued operations |
$ 0
|
|
$ 0
|
|
$ 5,301
|
Liabilities held for sale of discontinued operations, current |
|
|
|
|
|
Total current liabilities of discontinued operations |
0
|
|
0
|
|
5,072
|
Depreciation |
|
|
1,585
|
$ 684
|
|
Amortization |
|
|
12
|
30
|
|
Write-off of inventory associated with discontinued product |
|
|
0
|
298
|
|
Share-based compensation |
|
|
3,327
|
3,018
|
|
Additions to property and equipment |
|
|
39,800
|
983
|
|
Discontinued Operations, Disposed of by Sale [Member] | Cesium-131 Business [Member] |
|
|
|
|
|
Assets held for sale of discontinued operations, current |
|
|
|
|
|
Inventory |
0
|
|
0
|
|
3,148
|
Prepaid expenses and other current assets |
0
|
|
0
|
|
169
|
Property and equipment, net |
0
|
|
0
|
|
1,263
|
Right-of-use asset, net |
0
|
|
0
|
|
676
|
Other assets, net |
0
|
|
0
|
|
45
|
Total current assets held for sale of discontinued operations |
0
|
|
0
|
|
5,301
|
Liabilities held for sale of discontinued operations, current |
|
|
|
|
|
Lease liability |
0
|
|
0
|
|
677
|
Asset retirement obligation |
0
|
|
0
|
|
225
|
Loss recognized on classification as held for sale |
0
|
|
0
|
|
4,170
|
Total current liabilities of discontinued operations |
0
|
|
0
|
|
$ 5,072
|
Sales, net |
0
|
$ 1,909
|
2,178
|
5,239
|
|
Cost of sales |
0
|
1,447
|
1,564
|
4,863
|
|
Gross profit |
0
|
462
|
614
|
376
|
|
Research and development |
0
|
169
|
69
|
1,000
|
|
Sales and marketing |
0
|
855
|
941
|
2,578
|
|
General and administrative |
0
|
222
|
494
|
668
|
|
Total operating expenses |
0
|
1,246
|
1,504
|
4,246
|
|
Total loss from discontinued operations |
$ (0)
|
$ (784)
|
(890)
|
(3,870)
|
|
Depreciation |
|
|
0
|
171
|
|
Amortization |
|
|
0
|
27
|
|
Write-off of inventory associated with discontinued product |
|
|
0
|
298
|
|
Share-based compensation |
|
|
166
|
568
|
|
Additions to property and equipment |
|
|
$ 0
|
$ 287
|
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v3.24.3
Note 5 - Property and Equipment (Details Textual) € in Millions |
|
|
|
|
9 Months Ended |
12 Months Ended |
Oct. 13, 2024
USD ($)
|
Sep. 18, 2024
EUR (€)
|
Aug. 02, 2024
USD ($)
|
Jul. 15, 2024
USD ($)
|
Sep. 30, 2024
USD ($)
|
Sep. 30, 2023
USD ($)
|
Dec. 31, 2023
USD ($)
|
Property, Plant and Equipment [Line Items] |
|
|
|
|
|
|
|
Depreciation expense |
|
|
|
|
$ 1,585,000
|
$ 684,000
|
|
Consideration for equipment and services pursuant to the MESA and SOWs | € |
|
€ 49.0
|
|
|
|
|
|
Houston Texas [Member] |
|
|
|
|
|
|
|
Property, Plant and Equipment [Line Items] |
|
|
|
|
|
|
|
Payments to purchase buildings |
|
|
|
$ 4,700,000
|
|
|
|
Chicago Illinois [Member] |
|
|
|
|
|
|
|
Property, Plant and Equipment [Line Items] |
|
|
|
|
|
|
|
Payments to purchase buildings |
|
|
$ 5,000,000
|
|
|
|
|
Chino California [Member] | Subsequent Event [Member] |
|
|
|
|
|
|
|
Property, Plant and Equipment [Line Items] |
|
|
|
|
|
|
|
Payments to purchase buildings |
$ 11,000,000
|
|
|
|
|
|
|
Other [Member] |
|
|
|
|
|
|
|
Property, Plant and Equipment [Line Items] |
|
|
|
|
|
|
|
Depreciation expense |
|
|
|
|
$ 0
|
|
$ 0
|
X |
- DefinitionAmount of contingent consideration recognized as part of consideration transferred in asset acquisition.
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v3.24.3
Note 5 - Property and Equipment - Summary of Property and Equipment (Details) - USD ($) $ in Thousands |
Sep. 30, 2024 |
Dec. 31, 2023 |
Property, Plant and Equipment [Line Items] |
|
|
|
Property and equipment, gross |
|
$ 46,046
|
$ 6,245
|
Less accumulated depreciation |
|
(2,254)
|
(669)
|
Property and equipment, net |
|
43,792
|
5,576
|
Building [Member] |
|
|
|
Property, Plant and Equipment [Line Items] |
|
|
|
Property and equipment, gross |
|
1,770
|
1,770
|
Land [Member] |
|
|
|
Property, Plant and Equipment [Line Items] |
|
|
|
Property and equipment, gross |
|
1,283
|
1,283
|
Equipment [Member] |
|
|
|
Property, Plant and Equipment [Line Items] |
|
|
|
Property and equipment, gross |
|
10,601
|
2,683
|
Leasehold Improvements [Member] |
|
|
|
Property, Plant and Equipment [Line Items] |
|
|
|
Property and equipment, gross |
|
3,497
|
179
|
Other [Member] |
|
|
|
Property, Plant and Equipment [Line Items] |
|
|
|
Property and equipment, gross |
[1] |
$ 28,895
|
$ 330
|
|
|
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v3.24.3
Note 9 - Share-Based Compensation (Details Textual) - Amended 2020 Incentive Plan [Member] - shares
|
Aug. 14, 2024 |
May 31, 2024 |
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] |
|
|
Share-Based Compensation Arrangement by Share-Based Payment Award, Number of Additional Shares Authorized (in shares) |
4,870,092
|
4,870,092
|
Share-based Compensation Arrangement by Share-based Payment Award, Number of Shares Authorized (in shares) |
|
12,500,000
|
Percentage of increase in common stock capital shares for future issuance |
|
5.00%
|
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v3.24.3
Note 9 - Share-Based Compensation - Summary of Share-based Compensation Expense Recognized for Share-based Compensation Arrangements Excluding Share-based Compensation Expense (Details) - USD ($) $ in Thousands |
3 Months Ended |
9 Months Ended |
Sep. 30, 2024 |
Sep. 30, 2023 |
Sep. 30, 2024 |
Sep. 30, 2023 |
Share-Based Payment Arrangement, Expensed and Capitalized, Amount [Line Items] |
|
|
|
|
Share-based compensation |
$ 1,952
|
$ 418
|
$ 3,161
|
$ 2,450
|
Research and Development [Member] |
|
|
|
|
Share-Based Payment Arrangement, Expensed and Capitalized, Amount [Line Items] |
|
|
|
|
Share-based compensation |
814
|
179
|
1,336
|
763
|
General and Administrative [Member] |
|
|
|
|
Share-Based Payment Arrangement, Expensed and Capitalized, Amount [Line Items] |
|
|
|
|
Share-based compensation |
$ 1,138
|
$ 239
|
$ 1,825
|
$ 1,687
|
X |
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v3.24.3
Note 11 - Related Parties (Detailed Textual) - USD ($) $ in Millions |
Mar. 04, 2024 |
Jan. 08, 2024 |
Mar. 06, 2024 |
Lantheus Investment Agreement [Member] |
|
|
|
Related Party Transaction [Line Items] |
|
|
|
Shares issued and sell |
|
5,634,235
|
|
Percent of outstanding shares |
|
19.99%
|
|
Purchase price |
|
$ 8.0
|
|
Lantheus Alpha Therapy, LLC [Member] | Lantheus Investment Agreement [Member] |
|
|
|
Related Party Transaction [Line Items] |
|
|
|
Shares issued and sell |
9,200,998
|
5,634,235
|
|
Percent of outstanding shares |
|
19.99%
|
19.90%
|
Progenics APA [Member] |
|
|
|
Related Party Transaction [Line Items] |
|
|
|
Purchase price |
|
$ 8.0
|
|
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v3.24.3
Note 12 - Leases (Details Textual) $ in Thousands |
|
3 Months Ended |
9 Months Ended |
|
|
|
|
Aug. 08, 2024
USD ($)
RenewalOption
|
Sep. 30, 2024
USD ($)
|
Sep. 30, 2023
USD ($)
|
Sep. 30, 2024
USD ($)
|
Sep. 30, 2023
USD ($)
|
Apr. 01, 2024
USD ($)
|
Mar. 01, 2024
USD ($)
|
Dec. 31, 2023
USD ($)
|
Jul. 01, 2023
USD ($)
|
Lessee, Lease, Description [Line Items] |
|
|
|
|
|
|
|
|
|
Lease liability |
|
$ 2,579
|
|
$ 2,579
|
|
|
|
|
|
Right of use asset |
|
$ 2,433
|
|
$ 2,433
|
|
|
|
$ 747
|
|
Lease term |
52 months
|
|
|
|
|
|
|
|
|
Operating lease, weighted average remaining term |
|
3 years 2 months 12 days
|
|
3 years 2 months 12 days
|
|
|
|
|
|
Operating lease, weighted average discount rate |
|
8.00%
|
|
8.00%
|
|
|
|
|
|
Operating lease, expense |
|
$ 300
|
$ 200
|
$ 500
|
$ 400
|
|
|
|
|
Estimated hazardous waste removal liability |
|
$ 500
|
|
$ 500
|
|
|
|
$ 500
|
|
Lantheus Alpha Therapy, LLC [Member] |
|
|
|
|
|
|
|
|
|
Lessee, Lease, Description [Line Items] |
|
|
|
|
|
|
|
|
|
Number of renewal options | RenewalOption |
0
|
|
|
|
|
|
|
|
|
Maximum [Member] | Lantheus Alpha Therapy, LLC [Member] |
|
|
|
|
|
|
|
|
|
Lessee, Lease, Description [Line Items] |
|
|
|
|
|
|
|
|
|
Base prepaid rent |
$ 100
|
|
|
|
|
|
|
|
|
Office Space With Unico Properties [Member] |
|
|
|
|
|
|
|
|
|
Lessee, Lease, Description [Line Items] |
|
|
|
|
|
|
|
|
|
Lease liability |
|
|
|
|
|
|
|
|
$ 800
|
Right of use asset |
|
|
|
|
|
|
|
|
$ 800
|
Lessee, operating lease, discount rate |
|
|
|
|
|
|
|
|
8.00%
|
Lease with Board of Regents [Member] |
|
|
|
|
|
|
|
|
|
Lessee, Lease, Description [Line Items] |
|
|
|
|
|
|
|
|
|
Lease liability |
|
|
|
|
|
$ 1,100
|
|
|
|
Right of use asset |
|
|
|
|
|
$ 1,100
|
|
|
|
Lessee, operating lease, discount rate |
|
|
|
|
|
8.00%
|
|
|
|
Progenics [Member] |
|
|
|
|
|
|
|
|
|
Lessee, Lease, Description [Line Items] |
|
|
|
|
|
|
|
|
|
Lease liability |
600
|
|
|
|
|
|
$ 300
|
|
|
Right of use asset |
$ 600
|
|
|
|
|
|
$ 300
|
|
|
Lessee, operating lease, discount rate |
8.00%
|
|
|
|
|
|
8.00%
|
|
|
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v3.24.3
Note 13 - Notes Payable (Details Textual) $ in Thousands |
Jul. 19, 2019
USD ($)
MonthlyPayments
|
Sep. 30, 2024
USD ($)
|
Dec. 31, 2023
USD ($)
|
Dec. 29, 2022
USD ($)
|
Debt Instrument [Line Items] |
|
|
|
|
Notes payable, current |
|
$ 51
|
$ 49
|
|
Promissory Note [Member] |
|
|
|
|
Debt Instrument [Line Items] |
|
|
|
|
Notes payable, current |
|
$ 51
|
$ 49
|
|
Viewpoint Molecular Targeting, Inc. [Member] | Promissory Note [Member] |
|
|
|
|
Debt Instrument [Line Items] |
|
|
|
|
Debt instrument, face amount |
$ 100
|
|
|
|
Debt instrument, interest rate |
3.00%
|
|
|
|
Debt instrument, number of monthly payments | MonthlyPayments |
36
|
|
|
|
Amount raised through selling of equity |
$ 1,000
|
|
|
|
Viewpoint Molecular Targeting, Inc. [Member] | Promissory Note for Purchasing Land and Building [Member] |
|
|
|
|
Debt Instrument [Line Items] |
|
|
|
|
Debt instrument, face amount |
|
|
|
$ 1,700
|
Debt instrument, interest rate |
|
|
|
6.15%
|
Debt instrument balloon payment |
|
|
|
$ 1,500
|
X |
- DefinitionRepresents number of installment to pay debt.
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v3.24.3
Note 13 - Notes Payable - Summary of Note Payable (Details) - USD ($) $ in Thousands |
Sep. 30, 2024 |
Dec. 31, 2023 |
Debt Instrument [Line Items] |
|
|
Less: current portion |
$ (51)
|
$ (49)
|
Note payable, long-term portion |
1,638
|
1,676
|
Promissory Note [Member] |
|
|
Debt Instrument [Line Items] |
|
|
Note payable |
1,689
|
1,725
|
Less: current portion |
(51)
|
(49)
|
Note payable, long-term portion |
$ 1,638
|
$ 1,676
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v3.24.3
Note 14 - Merger (Details Textual) - USD ($) $ / shares in Units, $ in Thousands |
|
3 Months Ended |
9 Months Ended |
|
Feb. 03, 2023 |
Sep. 30, 2024 |
Sep. 30, 2023 |
Sep. 30, 2024 |
Sep. 30, 2023 |
Nov. 22, 2022 |
Business Acquisition [Line Items] |
|
|
|
|
|
|
Grant revenue |
|
$ 369
|
$ 276
|
$ 1,220
|
$ 1,097
|
|
Operating loss |
|
(18,634)
|
(9,750)
|
(45,902)
|
(29,265)
|
|
Viewpoint Molecular Targeting, Inc. [Member] |
|
|
|
|
|
|
Business Acquisition [Line Items] |
|
|
|
|
|
|
Business acquisition, percentage of voting interests acquired |
100.00%
|
|
|
|
|
|
Business acquisition, number of common shares exchanged |
13,654,507
|
|
|
|
|
|
Business combination, fair value of common stock |
$ 54,618
|
|
|
|
|
|
Business acquisition, closing market price |
$ 4
|
|
|
|
|
|
Note receivable, forgiven amount |
$ 6,200
|
|
|
|
|
|
Grant revenue |
|
400
|
300
|
1,200
|
1,100
|
|
Operating loss |
|
$ (18,600)
|
$ (9,800)
|
$ (45,900)
|
$ (29,300)
|
|
Viewpoint Molecular Targeting, Inc. [Member] | Isoray Note [Member] |
|
|
|
|
|
|
Business Acquisition [Line Items] |
|
|
|
|
|
|
Note receivable, forgiven amount, loan |
|
|
|
|
|
$ 6,000
|
Accrued interest |
|
|
|
|
|
$ 200
|
X |
- DefinitionNumber of shares of equity interests issued or issuable to acquire entity.
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Note 14 - Merger - Summary of Preliminary Purchase Price Allocation (Details) - USD ($) $ in Thousands |
Feb. 03, 2023 |
Sep. 30, 2024 |
Dec. 31, 2023 |
Business Acquisition [Line Items] |
|
|
|
Goodwill |
|
$ 24,062
|
$ 24,062
|
Viewpoint Molecular Targeting, Inc. [Member] |
|
|
|
Business Acquisition [Line Items] |
|
|
|
Cash and cash equivalents |
$ 2,699
|
|
|
Grants receivable |
95
|
|
|
Prepaid expenses |
396
|
|
|
Property and equipment |
5,050
|
|
|
Right-of-use asset |
10
|
|
|
Intangible assets, in-process research and development |
50,000
|
|
|
Other assets |
316
|
|
|
Total assets acquired |
58,566
|
|
|
Accounts payable and accrued expenses |
2,968
|
|
|
Lease liability |
10
|
|
|
Accrued payroll and related taxes |
1,642
|
|
|
Accrued vacation |
333
|
|
|
Notes payable |
1,807
|
|
|
Deferred tax liability |
7,243
|
|
|
Total liabilities assumed |
14,003
|
|
|
Net assets acquired, excluding goodwill |
44,563
|
|
|
Total purchase price consideration |
68,625
|
|
|
Goodwill |
$ 24,062
|
|
|
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