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Table of Contents
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, DC 20549
FORM 10-Q
☒ QUARTERLY REPORT PURSUANT
TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
For the quarterly period ended June 30, 2024
or
☐ TRANSITION REPORT
PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
For the transition period from
to
Commission File Number: 001-37937
XENETIC BIOSCIENCES,
INC.
(Exact name of registrant as specified in its
charter)
Nevada
(State or other jurisdiction of
incorporation or organization) |
45-2952962
(IRS Employer
Identification No.) |
945 Concord Street
Framingham, Massachusetts 01701
(Address of principal executive offices and
zip code)
781-778-7720
(Registrant’s telephone number, including
area code)
Securities registered pursuant to Section 12(b)
of the Act:
Title of each class |
Trading Symbol(s) |
Name of each exchange on which registered |
Common Stock, $0.001 par value per share |
XBIO |
The Nasdaq Stock Market |
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:
Large accelerated filer |
☐ |
|
Accelerated filer |
☐ |
Non-accelerated filer |
☒ |
|
Smaller reporting company |
☒ |
|
|
|
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 ☒
As of August 9, 2024, the number of outstanding
shares of the registrant’s common stock was 1,542,139.
XENETIC BIOSCIENCES, INC.
FORM 10-Q
QUARTERLY PERIOD ENDED JUNE 30, 2024
PART I – FINANCIAL INFORMATION
ITEM 1 – FINANCIAL STATEMENTS
XENETIC BIOSCIENCES, INC.
CONDENSED CONSOLIDATED BALANCE SHEETS
| |
June 30, 2024 | | |
December 31, 2023 | |
| |
(Unaudited) | | |
| |
| |
| | |
| |
ASSETS | |
| | | |
| | |
Current assets: | |
| | | |
| | |
Cash | |
$ | 7,298,597 | | |
$ | 8,983,046 | |
Prepaid expenses, receivables and other | |
| 716,381 | | |
| 603,828 | |
Total current assets | |
| 8,014,978 | | |
| 9,586,874 | |
| |
| | | |
| | |
Other assets | |
| 1,018,352 | | |
| 1,018,352 | |
Total assets | |
$ | 9,033,330 | | |
$ | 10,605,226 | |
| |
| | | |
| | |
LIABILITIES AND STOCKHOLDERS' EQUITY | |
| | | |
| | |
Current liabilities: | |
| | | |
| | |
Accounts payable | |
$ | 283,586 | | |
$ | 240,832 | |
Accrued expenses and other current liabilities | |
| 1,304,016 | | |
| 568,753 | |
Total current liabilities | |
| 1,587,602 | | |
| 809,585 | |
| |
| | | |
| | |
Total liabilities | |
| 1,587,602 | | |
| 809,585 | |
| |
| | | |
| | |
Commitments and contingencies | |
| – | | |
| – | |
Stockholders' equity: | |
| | | |
| | |
Preferred stock, 10,000,000 shares authorized | |
| – | | |
| – | |
Series B, $0.001 par value: 1,804,394 shares issued and outstanding as of June 30, 2024 and December 31, 2023 | |
| 1,804 | | |
| 1,804 | |
Common stock, $0.001 par value; 10,000,000 shares authorized as of June 30, 2024 and December 31, 2023; 1,543,802 and 1,543,385 shares issued as of June 30, 2024 and December 31, 2023, respectively; 1,541,101 and 1,540,684 shares outstanding as of June 30, 2024 and December 31, 2023, respectively | |
| 1,544 | | |
| 1,544 | |
Additional paid in capital | |
| 208,173,105 | | |
| 208,053,935 | |
Accumulated deficit | |
| (195,703,279 | ) | |
| (193,234,196 | ) |
Accumulated other comprehensive income | |
| 253,734 | | |
| 253,734 | |
Treasury stock | |
| (5,281,180 | ) | |
| (5,281,180 | ) |
Total stockholders' equity | |
| 7,445,728 | | |
| 9,795,641 | |
Total liabilities and stockholders' equity | |
$ | 9,033,330 | | |
$ | 10,605,226 | |
The accompanying notes are an integral part of
these unaudited condensed consolidated financial statements.
XENETIC BIOSCIENCES, INC.
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
(Unaudited)
| |
| | |
| | |
| | |
| |
| |
THREE MONTHS ENDED JUNE 30, | | |
SIX MONTHS ENDED JUNE 30, | |
| |
2024 | | |
2023 | | |
2024 | | |
2023 | |
| |
| | |
| | |
| | |
| |
Revenue: | |
| | | |
| | | |
| | | |
| | |
Royalty revenue | |
$ | 726,404 | | |
$ | 651,005 | | |
$ | 1,237,221 | | |
$ | 1,256,849 | |
Total revenue | |
| 726,404 | | |
| 651,005 | | |
| 1,237,221 | | |
| 1,256,849 | |
| |
| | | |
| | | |
| | | |
| | |
Operating costs and expenses: | |
| | | |
| | | |
| | | |
| | |
Research and development | |
| (933,771 | ) | |
| (903,243 | ) | |
| (1,878,092 | ) | |
| (1,498,519 | ) |
General and administrative | |
| (1,130,029 | ) | |
| (945,950 | ) | |
| (1,964,939 | ) | |
| (1,871,693 | ) |
Total operating costs and expenses | |
| (2,063,800 | ) | |
| (1,849,193 | ) | |
| (3,843,031 | ) | |
| (3,370,212 | ) |
Loss from operations | |
| (1,337,396 | ) | |
| (1,198,188 | ) | |
| (2,605,810 | ) | |
| (2,113,363 | ) |
| |
| | | |
| | | |
| | | |
| | |
Other income (expense): | |
| | | |
| | | |
| | | |
| | |
Other (expense) income | |
| (21 | ) | |
| 21,122 | | |
| 31 | | |
| 25,642 | |
Interest income, net | |
| 63,447 | | |
| 126,103 | | |
| 136,696 | | |
| 180,204 | |
Total other income | |
| 63,426 | | |
| 147,225 | | |
| 136,727 | | |
| 205,846 | |
| |
| | | |
| | | |
| | | |
| | |
Net loss | |
$ | (1,273,970 | ) | |
$ | (1,050,963 | ) | |
$ | (2,469,083 | ) | |
$ | (1,907,517 | ) |
| |
| | | |
| | | |
| | | |
| | |
Basic and diluted net loss per share | |
$ | (0.83 | ) | |
$ | (0.69 | ) | |
$ | (1.60 | ) | |
$ | (1.25 | ) |
| |
| | | |
| | | |
| | | |
| | |
Weighted-average shares of common stock outstanding, basic and diluted | |
| 1,540,799 | | |
| 1,524,717 | | |
| 1,540,741 | | |
| 1,520,710 | |
The accompanying notes are an integral part of
these unaudited condensed consolidated financial statements.
XENETIC BIOSCIENCES, INC.
CONDENSED CONSOLIDATED STATEMENTS OF CHANGES
IN STOCKHOLDERS' EQUITY
(Unaudited)
THREE MONTHS ENDED JUNE 30, 2024
| |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | |
| |
Preferred
Stock | | |
Common
Stock | | |
| | |
| | |
Accumulated | | |
| | |
| |
| |
Number
of
Shares | | |
Par
Value
($0.001) | | |
Number
of
Shares | | |
Par
Value
($0.001) | | |
Additional Paid
in Capital | | |
Accumulated
Deficit | | |
Other Comprehensive
Income | | |
Treasury
Stock | | |
Total Stockholders'
Equity | |
Balance as of April
1, 2024 | |
| 1,804,394 | | |
$ | 1,804 | | |
| 1,543,385 | | |
$ | 1,544 | | |
$ | 208,131,009 | | |
$ | (194,429,309 | ) | |
$ | 253,734 | | |
$ | (5,281,180 | ) | |
$ | 8,677,602 | |
Issuance of common stock in connection
with restricted stock | |
| – | | |
| – | | |
| 417 | | |
| – | | |
| – | | |
| – | | |
| – | | |
| – | | |
| – | |
Share-based expense | |
| – | | |
| – | | |
| – | | |
| – | | |
| 42,096 | | |
| – | | |
| – | | |
| – | | |
| 42,096 | |
Net loss | |
| – | | |
| – | | |
| – | | |
| – | | |
| – | | |
| (1,273,970 | ) | |
| – | | |
| – | | |
| (1,273,970 | ) |
Balance as
of June 30, 2024 | |
| 1,804,394 | | |
$ | 1,804 | | |
| 1,543,802 | | |
$ | 1,544 | | |
$ | 208,173,105 | | |
$ | (195,703,279 | ) | |
$ | 253,734 | | |
$ | (5,281,180 | ) | |
$ | 7,445,728 | |
SIX MONTHS ENDED JUNE 30, 2024
| |
Preferred
Stock | | |
Common
Stock | | |
| | |
| | |
Accumulated | | |
| | |
| |
| |
Number
of Shares | | |
Par
Value ($0.001) | | |
Number
of Shares | | |
Par
Value ($0.001) | | |
Additional Paid
in Capital | | |
Accumulated
Deficit | | |
Other Comprehensive
Income | | |
Treasury
Stock | | |
Total Stockholders'
Equity | |
Balance as of January
1, 2024 | |
| 1,804,394 | | |
$ | 1,804 | | |
| 1,543,385 | | |
$ | 1,544 | | |
$ | 208,053,935 | | |
$ | (193,234,196 | ) | |
$ | 253,734 | | |
$ | (5,281,180 | ) | |
$ | 9,795,641 | |
Issuance of common stock in connection
with restricted stock | |
| – | | |
| – | | |
| 417 | | |
| – | | |
| – | | |
| – | | |
| – | | |
| – | | |
| – | |
Share-based expense | |
| – | | |
| – | | |
| – | | |
| – | | |
| 119,170 | | |
| – | | |
| – | | |
| – | | |
| 119,170 | |
Net loss | |
| – | | |
| – | | |
| – | | |
| – | | |
| – | | |
| (2,469,083 | ) | |
| – | | |
| – | | |
| (2,469,083 | ) |
Balance as
of June 30, 2024 | |
| 1,804,394 | | |
$ | 1,804 | | |
| 1,543,802 | | |
$ | 1,544 | | |
$ | 208,173,105 | | |
$ | (195,703,279 | ) | |
$ | 253,734 | | |
$ | (5,281,180 | ) | |
$ | 7,445,728 | |
The accompanying notes are an integral part of
these unaudited condensed consolidated financial statements.
XENETIC BIOSCIENCES, INC.
CONDENSED CONSOLIDATED STATEMENTS OF CHANGES
IN STOCKHOLDERS' EQUITY
(Unaudited)
THREE MONTHS ENDED JUNE 30, 2023
| |
Preferred
Stock | | |
Common
Stock | | |
| | |
| | |
Accumulated | | |
| | |
| |
| |
Number
of Shares | | |
Par
Value ($0.001) | | |
Number
of Shares | | |
Par
Value ($0.001) | | |
Additional Paid
in Capital | | |
Accumulated
Deficit | | |
Other Comprehensive
Income | | |
Treasury
Stock | | |
Total
Stockholders’ Equity | |
Balance as of April
1, 2023 | |
| 2,774,394 | | |
$ | 2,774 | | |
| 1,519,360 | | |
$ | 1,520 | | |
$ | 207,838,756 | | |
$ | (189,956,172 | ) | |
$ | 253,734 | | |
$ | (5,281,180 | ) | |
$ | 12,859,432 | |
Issuance of common stock to adjust
for reverse split rounding | |
| – | | |
| – | | |
| 15,941 | | |
| 16 | | |
| (16 | ) | |
| – | | |
| – | | |
| – | | |
| – | |
Share-based expense | |
| – | | |
| – | | |
| – | | |
| – | | |
| 69,389 | | |
| – | | |
| – | | |
| – | | |
| 69,389 | |
Net loss | |
| – | | |
| – | | |
| – | | |
| – | | |
| – | | |
| (1,050,963 | ) | |
| – | | |
| – | | |
| (1,050,963 | ) |
Balance as
of June 30, 2023 | |
| 2,774,394 | | |
$ | 2,774 | | |
| 1,535,301 | | |
$ | 1,536 | | |
$ | 207,908,129 | | |
$ | (191,007,135 | ) | |
$ | 253,734 | | |
$ | (5,281,180 | ) | |
$ | 11,877,858 | |
SIX MONTHS ENDED JUNE 30, 2023
| |
Preferred
Stock | | |
Common
Stock | | |
| | |
| | |
Accumulated | | |
| | |
| |
| |
Number
of Shares | | |
Par
Value ($0.001) | | |
Number
of Shares | | |
Par
Value ($0.001) | | |
Additional Paid
in Capital | | |
Accumulated
Deficit | | |
Other Comprehensive
Income | | |
Treasury
Stock | | |
Total Stockholders'
Equity | |
Balance as of January
1, 2023 | |
| 2,774,394 | | |
$ | 2,774 | | |
| 1,519,360 | | |
$ | 1,520 | | |
$ | 207,769,904 | | |
$ | (189,099,618 | ) | |
$ | 253,734 | | |
$ | (5,281,180 | ) | |
$ | 13,647,134 | |
Issuance of common stock to adjust
for reverse split rounding | |
| – | | |
| – | | |
| 15,941 | | |
| 16 | | |
| (16 | ) | |
| – | | |
| – | | |
| – | | |
| – | |
Share-based expense | |
| – | | |
| – | | |
| – | | |
| – | | |
| 138,241 | | |
| – | | |
| – | | |
| – | | |
| 138,241 | |
Net loss | |
| – | | |
| – | | |
| – | | |
| – | | |
| – | | |
| (1,907,517 | ) | |
| – | | |
| – | | |
| (1,907,517 | ) |
Balance as
of June 30, 2023 | |
| 2,774,394 | | |
$ | 2,774 | | |
| 1,535,301 | | |
$ | 1,536 | | |
$ | 207,908,129 | | |
$ | (191,007,135 | ) | |
$ | 253,734 | | |
$ | (5,281,180 | ) | |
$ | 11,877,858 | |
The accompanying notes are an integral part of
these unaudited condensed consolidated financial statements.
XENETIC BIOSCIENCES, INC.
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS
(Unaudited)
| |
| | |
| |
| |
Six Months Ended June 30, | |
| |
2024 | | |
2023 | |
| |
| | |
| |
CASH FLOWS FROM OPERATING ACTIVITIES: | |
| | | |
| | |
Net loss | |
$ | (2,469,083 | ) | |
$ | (1,907,517 | ) |
Adjustments to reconcile net loss to net cash used in operating activities: | |
| | | |
| | |
Share-based expense | |
| 119,170 | | |
| 138,241 | |
Changes in operating assets and liabilities: | |
| | | |
| | |
Prepaid expenses, receivables and other | |
| (112,553 | ) | |
| (762,941 | ) |
Other assets | |
| – | | |
| 362,500 | |
Accounts payable, accrued expenses and other liabilities | |
| 778,017 | | |
| (201,841 | ) |
Net cash used in operating activities | |
| (1,684,449 | ) | |
| (2,371,558 | ) |
| |
| | | |
| | |
Net change in cash | |
| (1,684,449 | ) | |
| (2,371,558 | ) |
Cash at beginning of period | |
| 8,983,046 | | |
| 13,097,265 | |
| |
| | | |
| | |
Cash at end of period | |
$ | 7,298,597 | | |
$ | 10,725,707 | |
| |
| | | |
| | |
SUPPLEMENTAL CASH FLOW INFORMATION: | |
| | | |
| | |
Cash paid for interest | |
$ | – | | |
$ | – | |
The accompanying notes are an integral part of
these unaudited condensed consolidated financial statements.
XENETIC BIOSCIENCES, INC.
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
(Unaudited)
Background
Xenetic Biosciences, Inc. (“Xenetic”
or the “Company”), incorporated in the state of Nevada and based in Framingham, Massachusetts, is a biopharmaceutical company
focused on advancing innovative immune-oncology technologies addressing hard to treat cancers. The Company’s proprietary Deoxyribonuclease
(“DNase”) platform is designed to improve outcomes of existing treatments, including immunotherapies, by targeting neutrophil
extracellular traps (“NETs”), which have been implicated in cancer progression and resistance to cancer treatments. Xenetic
is currently focused on advancing its systemic DNase program into the clinic as an adjunctive therapy for pancreatic carcinoma and locally
advanced or metastatic solid tumors. Additionally, Xenetic has partnered with biotechnology and pharmaceutical companies to develop its
proprietary drug delivery platform, PolyXen®, and receives royalty payments under an exclusive license arrangement in the
field of blood coagulation disorders.
As used in this Quarterly Report on Form 10-Q
(“Quarterly Report”), unless otherwise indicated, all references herein to “Xenetic,” the “Company,”
“we” or “us” refer to Xenetic Biosciences, Inc. and its wholly-owned subsidiaries.
The Company, directly or indirectly, through its
wholly-owned subsidiaries, Hesperix S.A. (“Hesperix”) and Xenetic Biosciences (U.K.) Limited (“Xenetic UK”), and
the wholly-owned subsidiaries of Xenetic UK, Lipoxen Technologies Limited (“Lipoxen”), Xenetic Bioscience, Incorporated and
SymbioTec, GmbH (“SymbioTec”), own various United States (“U.S.”) federal trademark registrations and applications
along with unregistered trademarks and service marks, including but not limited to XCART™, OncoHist™, PolyXen, ErepoXen™,
and ImuXen™, which may be used throughout this Quarterly Report. All other company and product names may be trademarks of the respective
companies with which they are associated.
Going Concern and Management’s Plan
Management evaluates whether there are
conditions or events, considered in the aggregate, that raise substantial doubt about the Company’s ability to continue as a
going concern within one year after the date that the financial statements are issued. The Company has incurred substantial losses
since its inception and expects to continue to incur operating losses in the near-term. The Company believes that its existing
resources will be adequate to fund the Company’s operations for a period of at least twelve months from the date of the
issuance of these financial statements. However, the Company anticipates it will need additional capital in the long-term to pursue
its business initiatives. While the Company believes it has access to capital resources through possible public or private equity
offerings, debt financings, corporate collaborations, related party funding, or other means to continue as a going concern, the
terms, timing and extent of any future financing will depend upon several factors, including the achievement of progress in its
product development programs, its ability to identify and enter into licensing or other strategic arrangements, its continued
listing on the Nasdaq Stock Market (“Nasdaq”), and factors related to financial, economic, geo-political, industry and
market conditions, many of which are beyond its control. The capital markets for the biotech industry can be highly volatile, which
make the terms, timing and extent of any future financing uncertain.
2. |
Risks and Uncertainties |
Impact of Global
Conflicts on Operations
The short and long-term
implications of Russia’s invasion of Ukraine and conflict in the Middle East are difficult to predict at this time. The imposition
of current and future sanctions and counter sanctions may have an adverse effect on the economic markets generally and could impact our
business, financial condition, and results of operations.
3. |
Summary of Significant Accounting Policies |
Preparation of Interim Financial Statements
The accompanying condensed consolidated interim
financial statements were prepared by the Company pursuant to the rules and regulations of the Securities and Exchange Commission (“SEC”)
and, in the opinion of management, include all normal and recurring adjustments necessary to present fairly the results of the interim
periods shown. Certain information and footnote disclosures normally included in financial statements prepared in accordance with U.S.
generally accepted accounting principles have been condensed or omitted pursuant to such SEC rules and regulations. Management believes
that the disclosures made are adequate to make the information presented not misleading. The results for the interim periods are not necessarily
indicative of results for the full year. The condensed consolidated financial statements contained herein should be read in conjunction
with the consolidated financial statements and notes thereto included in the Company’s Annual Report on Form 10-K for the year ended
December 31, 2023 filed with the SEC on March 21, 2024, and amended on April 26, 2024.
On May 15, 2023, the Company effected a reduction,
on a 1-for-10 basis, in its authorized common stock, par value $0.001, along with a corresponding and proportional decrease in the number
of shares issued and outstanding (the “Reverse Stock Split”). On the effective date of the Reverse Stock Split, (i) every
10 shares of common stock were reduced to one share of common stock, with any fractional amounts rounded up to one share; (ii) the number
of shares of common stock into which each outstanding warrant, restricted stock unit (“RSU”), or option to purchase common
stock was convertible into was proportionately reduced on the same basis as the common stock; (iii) the exercise price of each outstanding
warrant or option to purchase common stock was proportionately increased on a 1-to-10 basis; and (iv) the number of shares of common stock
into which each share of preferred stock was convertible into was proportionately reduced on the same basis as the common stock. Unless
otherwise indicated, all of the share numbers, share prices, and exercise prices have been adjusted in this Quarterly Report, on a retroactive
basis, to reflect this 1-for-10 Reverse Stock Split.
Principles of Consolidation
The condensed consolidated financial statements
of the Company include the accounts of Hesperix, Xenetic UK and Xenetic UK’s wholly owned subsidiaries: Lipoxen, Xenetic Bioscience,
Incorporated, and SymbioTec. Certain of the Company’s subsidiaries require guarantees of support from Xenetic. While all intercompany
balances and transactions have been eliminated in consolidation, the Company has $0.2 million of cash collateralizing these guarantees.
Basic and Diluted Net Loss per Share
The Company computes basic net loss per share
by dividing net loss applicable to common stockholders by the weighted-average number of shares of the Company’s common stock outstanding
during the period. The Company computes diluted net loss per share after giving consideration to the dilutive effect of stock options
that are outstanding during the period, except where such non-participating securities would be anti-dilutive.
For the three and six months ended June 30, 2024
and 2023, basic and diluted net loss per share are the same in each respective period due to the Company’s net loss position. Potentially
dilutive, non-participating securities have not been included in the calculations of diluted net loss per share, as their inclusion would
be anti-dilutive.
4. |
Significant Strategic Collaborations |
Takeda Pharmaceutical Co. Ltd. (together
with its wholly-owned subsidiaries, “Takeda”)
In October 2017, the Company granted to Takeda
the right to grant a non-exclusive sublicense to certain patents related to the Company’s PolyXen technology that were previously
exclusively licensed to Takeda in connection with products related to the treatment of blood and bleeding disorders. Royalty payments
of approximately $0.7 million and $1.2 million were recorded as revenue by the Company during the three and six months ended June 30,
2024, respectively, and approximately $0.7 million and $1.3 million were recorded as revenue by the Company during the three and six months
ended June 30, 2023, respectively. These payments are based on single digit royalties on net sales of certain covered products. The Company’s
policy is to recognize royalty payments as revenue when they are reliably measurable, which is upon receipt of reports from Takeda. The
Company receives these reports in the quarter subsequent to the actual sublicensee sales. At the time the revenue was received, there
were no remaining performance obligations and all other revenue recognition criteria were met.
Belgian Volition SARL Limited (“Volition”)
Collaboration
On August 2, 2022, the Company announced a research
and development collaboration with Volition to develop NETs-targeted adoptive cell therapies for the treatment of cancer. The collaboration
is an early exploratory program to evaluate the potential combination of Volition’s Nu.Q® technology Test and the
Company’s DNase-Armored CAR T platform to develop proprietary adoptive cell therapies potentially targeting multiple types of solid
cancers. Under the terms of the collaboration agreement, Volition will fund a research program and the two parties will share proceeds
from commercialization or licensing of any products arising from the collaboration. To date, Volition has funded $26,000 under this agreement.
Catalent Pharma Solutions LLC (“Catalent”)
On June 30, 2022, the Company entered into a Statement
of Work (the “SOW”) with Catalent to outline the general scope of work, timeline, and pricing pursuant to which Catalent will
provide certain services to the Company to perform cGMP manufacturing of the Company’s recombinant protein, Human DNase I. The parties
agreed to enter into a Master Services Agreement that will contain terms and conditions to govern the project contemplated by the SOW
and that will supersede the addendum to the SOW containing Catalent's standard terms and conditions. The Company has paid Catalent approximately
$2.5 million through June 30, 2024, of which approximately $28,000 and $0.1 million has been recognized as an advance payment and is included
in prepaid expenses, receivables and other current assets as of June 30, 2024 and December 31, 2023, respectively, and approximately $49,000
has been recognized as a liability and is included in accrued expenses and other current liabilities as of June 30, 2024. There was no
accrual as of December 31, 2023. In addition, approximately $0.3 million has been recognized within other assets as of both June 30, 2024
and December 31, 2023.
Scripps Research Institute (“Scripps
Research”)
On March 17, 2023, the Company and Scripps Research
entered into a Research Funding and Option Agreement (the “Agreement”), pursuant to which the Company has agreed to provide
Scripps Research an aggregate of up to $0.9 million to fund research relating to advancing the pre-clinical development of the Company’s
DNase oncology platform technology. Under the Agreement, the Company has the option to acquire a worldwide exclusive license to Scripps
Research’s rights in the Technology or Patent Rights (as defined in the Agreement), as well as a non-exclusive, royalty-free, non-transferrable
license to make and use TSRI Technology (as defined in the Agreement) solely for the Company’s internal research purposes during
the performance of the research program contemplated by the Agreement. During the second quarter of 2024, the Company amended the
Agreement to extend the term to October 31, 2024 with no additional funding required. The Company has paid Scripps Research approximately
$0.9 million under the Agreement through June 30, 2024, of which approximately $0.1 million and $0.4 million has been recognized as an
advance payment and is included in prepaid expenses, receivables and other current assets as of June 30, 2024 and December 31, 2023, respectively.
University of Virginia (“UVA”)
On December 21, 2023, the Company entered into
a Research Funding and Material Transfer Agreement with UVA (the “UVA Agreement”) to advance the development of our systemic
DNase program. Under the terms of the UVA Agreement, in
addition to advancing our existing intellectual property, we have an option to acquire an exclusive license to any new intellectual property
arising from the DNase research program. Allan Tsung, MD, a member of the Company’s Scientific Advisory Board and Chair of
the Department of Surgery at the UVA School of Medicine, will oversee the research conducted under
the UVA Agreement. The Company has paid UVA approximately $0.2 million under the UVA Agreement through June 30, 2024, which was
expensed during the six months ended June 30, 2024. There were no amounts incurred as of December 31, 2023.
Other Agreements
The Company has also entered into various research,
development, license and supply agreements with Serum Institute of India (“Serum Institute”), PJSC Pharmsynthez (“Pharmsynthez”)
and SynBio LLC (“SynBio”), a wholly owned subsidiary of Pharmsynthez. The Company and its collaborative partners continue
to engage in research and development activities with no resultant commercial products through June 30, 2024. No amounts were recognized
as revenue related to the Serum Institute, Pharmsynthez or SynBio agreements during the three and six months ended June 30, 2024 and 2023,
respectively.
5. |
Accrued Expenses and Other Current Liabilities |
On June 19, 2024, the Company entered into a confidential
separation agreement and general release with each of Jeffrey F. Eisenberg, the Company’s former Chief Executive Officer (the “Eisenberg
Separation Agreement”), and Curtis Lockshin, the Company’s former Chief Scientific Officer (the “Lockshin Separation
Agreement” and together, the “Separation Agreements”) pursuant to which Messrs. Eisenberg and Lockshin were each eligible
for certain severance payments and benefits consistent with the terms of their existing employment agreements as described under “Employment
Agreements with our Named Executive Officers” in the Amendment No. 1 to Annual Report on Form 10-K/A filed by the Company with the
Securities and Exchange Commission on April 26, 2024. In addition, the Eisenberg Separation Agreement provides for accelerated vesting
of all of the unvested stock options held by Mr. Eisenberg as of May 16, 2024. As of June 30, 2024, the Company expensed approximately
$0.8 million of accrued payroll and benefits related to the Separation Agreements. In addition, the Company recorded approximately $13,000
of share-based expense for the accelerated vesting of unvested stock options. As of June 30, 2024, approximately $0.8 million was accrued
within accrued expenses and other current liabilities related to these obligations.
6. |
Fair Value Measurements |
Accounting Standards Codification Topic 820, Fair
Value Measurement, defines fair value as the price that would be received to sell an asset or be paid to transfer a liability in an
orderly transaction between market participants at the measurement date. The Company applies the following fair value hierarchy, which
prioritizes the inputs used to measure fair value into three levels and bases the categorization within the hierarchy upon the lowest
level of input that is available and significant to the fair value measurement. Level 1 inputs are unadjusted quoted prices in active
markets for identical assets or liabilities that the reporting entity has the ability to access at the measurement date. Level 2 utilizes
quoted market prices in markets that are not active, broker or dealer quotations, or alternative pricing sources with reasonable levels
of price transparency. Level 3 inputs are unobservable inputs for the asset or liability in which there is little, if any, market activity
for the asset or liability at the measurement date. As of June 30, 2024 and December 31, 2023, the carrying amounts of the Company’s
financial instruments approximates fair value due to their short maturities. There were no financial instruments classified as Level 3
in the fair value hierarchy during the three and six months ended June 30, 2024 and 2023.
Common Stock
Each share of the Company’s
common stock entitles the holder to one vote on all matters submitted to a vote of the Company’s stockholders. Common stockholders
are entitled to dividends when and if declared by the Board of Directors. In the event of any voluntary or involuntary liquidation, dissolution
or winding-up of the Company, the holders of common stock are entitled to share ratably in the assets of the Company available for distribution.
On May 11, 2023, the Company filed a Certificate
of Change to the Company’s Articles of Incorporation with the Secretary of State of Nevada to effect the Reverse Stock Split. The
Reverse Stock Split was effective at 12:01 a.m., Eastern Time, on May 15, 2023. No fractional shares were issued as a result of the Reverse
Stock Split and any remaining share fractions were rounded up to the nearest whole share, resulting in 15,941 new shares of common stock
being issued to existing holders of the Company’s common stock.
Warrants
The Company
has warrants to purchase approximately 462,963 shares of the Company’s common stock (the “Series A Warrants”) outstanding
as of both June 30, 2024 and December 31, 2023. The Series A Warrants are immediately exercisable at a price of $33.00 per share of common
stock and expire on February 23, 2025. No Series A Warrants were exercised or forfeited during the three and six months ended June 30,
2024 and 2023.
In addition, the Company had publicly traded
warrants to purchase approximately 2,100
shares of common stock outstanding as of both June 30, 2024 and December 31, 2023. These warrants had an exercise price of $130.00
per share of common stock and expired on July
19, 2024. The warrants ceased trading on Nasdaq under the symbol “XBIOW” upon expiration. The warrants also provided that
if the weighted-average price of common stock on any trading day on or after 30 days after issuance is lower than the
then-applicable exercise price per share, each warrant may be exercised, at the option of the holder, on a cashless basis for one
share of common stock. None
of these warrants were exercised or forfeited during the three and six months ended June 30, 2024 and 2023.
The Company also has warrants to purchase approximately 800 shares
of the Company’s common stock outstanding as of both June 30, 2024 and December 31,
2023. These warrants have an exercise price of $29.09 per share of common stock and expire on July 3, 2026. None of these warrants were
exercised or forfeited during the three and six months ended June 30, 2024 and 2023.
Total share-based expense related to stock options
and RSU’s was approximately $42,000 and $0.1 million for the three months ended June 30, 2024 and 2023, respectively, and approximately
$0.1 million and $0.1 million for each of the six months ended June 30, 2024 and 2023.
Share-based expense is classified in the condensed consolidated statements
of operations as follows:
Schedule of share-based compensation expense | |
| | | |
| | | |
| | | |
| | |
| |
Three Months Ended June 30, | | |
Six Months Ended June 30, | |
| |
2024 | | |
2023 | | |
2024 | | |
2023 | |
Research and development expenses | |
$ | (3,804 | ) | |
$ | 13,778 | | |
$ | 11,433 | | |
$ | 27,466 | |
General and administrative expenses | |
| 45,900 | | |
| 55,611 | | |
| 107,737 | | |
| 110,775 | |
| |
$ | 42,096 | | |
$ | 69,389 | | |
$ | 119,170 | | |
$ | 138,241 | |
Employee Stock Options and RSU’s
During the three and six months ended June 30,
2024, 20,000 stock options to purchase shares of common stock were granted by the Company. No stock option awards to purchase shares of
common stock were granted during the three and six months ended June 30, 2023. No RSUs were granted during each of the three and six months
ended June 30, 2024 and 2023. The Company recognized a total of approximately $42,000 and $0.1 million of share-based expense related
to employee stock options during the three months ended June 30, 2024 and 2023, respectively, and $0.1 million during each of the six
months ended June 30, 2024 and 2023, respectively. The Company issued 417 shares of common stock during the three and six months ended
June 30, 2024 related to RSU’s. No employee stock options were exercised during the three and six months ended June 30, 2024 and
2023. During the three and six months ended June 30, 2024 stock options to purchase 11,667 shares of common stock were forfeited. No employee
stock options expired during the three and six months ended June 30, 2023.
Non-Employee Stock Options
There were no non-employee stock options granted
or exercised during the three and six months ended June 30, 2024 and 2023, respectively. No non-employee stock option grants expired during
the three and six months ended June 30, 2024. During the six months ended June 30, 2023, non-employee stock option grants to purchase
approximately 100 shares of common stock expired. The Company did not recognize any expense related to non-employee stock options during
the three and six months ended June 30, 2024 and 2023, respectively.
During the three and six months ended June 30,
2024 and 2023, there was no provision for income taxes as the Company incurred losses during both periods. Deferred tax assets and liabilities
reflect the net tax effect of temporary differences between the carrying amount of assets and liabilities for financial reporting purposes
and the amounts used for income tax purposes. The Company records a valuation allowance against its deferred tax assets as the Company
believes it is more likely than not the deferred tax assets will not be realized. The valuation allowance against deferred tax assets
was approximately $40.4 million and $39.7 million as of June 30, 2024 and December 31, 2023, respectively.
As of June 30, 2024 and December 31, 2023,
the Company did not record any unrecognized tax positions.
10. |
Related Party Transactions |
The Company has entered into various research,
development, license and supply agreements with Serum Institute and Pharmsynthez, each a related party whose relationship has not materially
changed from that disclosed in the Company’s Annual Report on Form 10-K for the year ended December 31, 2023 filed with the SEC
on March 21, 2024, as amended on April 26, 2024.
During the fourth quarter
of 2019, the Company entered into a loan agreement with Pharmsynthez (the “Pharmsynthez Loan”), pursuant to which the Company
advanced Pharmsynthez an aggregate principal amount of up to $500,000 to be used for the development of a specific product under the Company’s
Co-Development Agreement with Pharmsynthez. The Pharmsynthez Loan had an initial term of 15-months and accrued interest at a rate of 10%
per annum. The Pharmsynthez Loan was guaranteed by all of the operating subsidiaries of Pharmsynthez, including SynBio and AS Kevelt,
and was secured by all of the common and preferred stock of the Company owned by Pharmsynthez and SynBio.
Pharmsynthez paid
all obligations due under the Pharmsynthez Loan in May 2023, and no further amounts are due under the Pharmsynthez Loan. As a
result, no amounts
were outstanding as of June 30, 2024 and December 31, 2023. The Company did not recognize any interest income related to the
Pharmsynthez Loan during the three and six months ended June 30, 2024. The Company recognized approximately $65,000 of
income related to interest and fees associated with the Pharmsynthez Loan including approximately $40,000 related
to interest income during the three and six months ended June 30, 2023.
ITEM 2 – MANAGEMENT’S DISCUSSION
AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS
CAUTIONARY NOTE REGARDING FORWARD-LOOKING STATEMENTS
This report contains forward-looking statements
within the meaning of Section 21E of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), and Section 27A
of the Securities Act of 1933, as amended. All statements contained in this Quarterly Report other than statements of historical fact,
including statements regarding our future results of operations and financial position, our business strategy and plans, future revenues,
projected costs, prospects and our objectives for future operations, are forward-looking statements. These forward-looking statements
include, but are not limited to, statements concerning: anticipated effects of geopolitical events, including the conflicts in the Ukraine
and the Middle East and associated sanctions imposed by the U.S. and other countries in response; our plans to develop our proposed drug
candidates; our expectations regarding the nature, timing and extent of clinical trials and proposed clinical trials; our expectations
regarding the timing for proposed submissions of regulatory filings; our expectations regarding the nature, timing and extent of collaboration
arrangements; the expected results pursuant to collaboration arrangements, including the receipts of future payments that may arise pursuant
to collaboration arrangements; the outcome of our plans to obtain regulatory approval of our drug candidates; the outcome of our plans
for the commercialization of our drug candidates; our plans to address certain markets, engage third party manufacturers, and evaluate
additional drug candidates for subsequent commercial development along with the likelihood and extent of competition to our drug candidates;
our plans to advance innovative immune-oncology technologies addressing hard to treat oncology indications; expectations regarding our
Deoxyribonuclease (“DNase”) platform, such as regarding the DNase platform being in development for the treatment of solid
tumors and being aimed at improving outcomes of existing treatments, including immunotherapies, by targeting neutrophil extracellular
traps (“NETs”); our expectations to focus our efforts and resources on advancing the DNase platform into the clinic as an
adjunctive therapy for pancreatic carcinoma and locally advanced or metastatic solid tumors; and our expectations regarding our PolyXen®
platform, including concerning our plans to leverage the platform.
In some cases, these statements
may be identified by terminology such as “may,” “will,” “would,” “could,” “should,”
“expect,” “plan,” “anticipate,” “believe,” “estimate,” “seek,”
“approximately,” “intend,” “predict,” “potential,” “projects,” or “continue,”
or the negative of such terms and other comparable terminology. Although we believe that the expectations reflected in the forward-looking
statements contained herein are reasonable, we cannot guarantee future results, the levels of activity, performance or achievements. These
statements involve known and unknown risks and uncertainties that may cause our or our industry's results, levels of activity, performance
or achievements to be materially different from those expressed or implied by forward-looking statements.
The Management’s Discussion and Analysis
of Financial Condition and Results of Operations (the “MD&A”) should be read together with our condensed consolidated
financial statements and related notes included elsewhere in this Quarterly Report. This Quarterly Report, including the MD&A, contains
trend analysis and other forward-looking statements. Any statements in this Quarterly Report that are not statements of historical facts
are forward-looking statements. These forward-looking statements made herein are based on our current expectations, involve a number of
risks and uncertainties and should not be considered as guarantees of future performance.
Some factors that could
cause actual results to differ materially include without limitation:
|
· |
uncertainty of the expected financial performance of the Company; |
|
· |
failure to realize the anticipated potential of the DNase or PolyXen technologies; |
|
· |
our ability to implement our business strategy; |
|
· |
our failure to maintain compliance with the continued listing requirements of the Nasdaq Stock Market (“Nasdaq”); |
|
· |
our need to raise additional working capital in the future for the purpose of further developing our pipeline and to continue as a going concern; |
|
· |
our ability to finance our business; |
|
· |
our ability to successfully execute, manage and integrate key acquisitions and mergers; |
|
· |
product development and commercialization risks, including our ability to successfully develop the DNase technology; |
|
· |
the impact of adverse safety outcomes and clinical trial results for our therapies; |
|
· |
our ability to secure and maintain a manufacturer for our technologies; |
|
· |
the impact of new therapies and new uses of existing therapies on the competitive environment; |
|
· |
our ability to successfully commercialize our current and future drug candidates; |
|
· |
our ability to achieve milestone and other payments associated with our current and future co-development collaborations and strategic arrangements; |
|
· |
our reliance on consultants, advisors, vendors and business partners to conduct work on our behalf; |
|
· |
the impact of new technologies on our drug candidates and our competition; |
|
· |
changes in laws or regulations of governmental agencies; |
|
· |
interruptions or cancellation of existing contracts; |
|
· |
impact of competitive products and pricing; |
|
· |
product demand and market acceptance and risks; |
|
· |
the presence of competitors with greater financial resources; |
|
· |
continued availability of supplies or materials used in manufacturing at the current prices; |
|
· |
the ability of management to execute plans and motivate personnel in the execution of those plans; |
|
· |
our ability to attract and retain key personnel; |
|
· |
costs, diversion and other adverse effects of the actions of activist shareholders; |
|
· |
adverse publicity related to our products or the Company itself; |
|
· |
adverse claims relating to our intellectual property; |
|
· |
the adoption of new, or changes in, accounting principles; |
|
· |
the costs inherent with complying with statutes and regulations applicable to public reporting companies, such as the Sarbanes-Oxley Act of 2002; |
|
· |
other new lines of business that we may enter in the future; |
|
· |
general economic and business conditions, as well as inflationary trends and financial market instability or disruptions to the banking system due to bank failures; |
|
· |
the impact of natural disasters or public health emergencies, such as the COVID-19 global pandemic, and geopolitical events, such as the Russian invasion of Ukraine and conflict in the Middle East, and related sanctions and other economic disruptions or concerns, on our financial condition and results of operations; and |
|
· |
other factors set forth in the Risk Factors section of our Annual Report on Form 10-K and in subsequent filings with the Securities and Exchange Commission (“SEC”). |
These factors are not necessarily all of the important
factors that could cause actual results to differ materially from those expressed in the forward-looking statements in this Quarterly
Report. Other unknown or unpredictable factors also could have material adverse effects on our future results, including, but not limited
to, those discussed in the section titled “Risk Factors.” The forward-looking statements in this Quarterly Report are made
only as of the date of this Quarterly Report, and we do not undertake any obligation to publicly update any forward-looking statements
to reflect subsequent events or circumstances. We intend that all forward-looking statements be subject to the safe-harbor provisions
of the Private Securities Litigation Reform Act of 1995.
BUSINESS OVERVIEW
We are a biopharmaceutical company focused on
advancing innovative immune-oncology technologies addressing hard to treat cancers. Our DNase platform is designed to improve outcomes
of existing treatments, including immunotherapies, by targeting NETs, which have been implicated in cancer progression and resistance
to cancer treatments. We are currently focused on advancing our systemic DNase program into the clinic as an adjunctive therapy for pancreatic
carcinoma and locally advanced or metastatic solid tumors. Additionally, we have partnered with biotechnology and pharmaceutical companies
to develop our proprietary drug delivery platform, PolyXen, and receive royalty payments under an exclusive license arrangement in the
field of blood coagulation disorders.
We incorporate our patented and proprietary technologies
into drug candidates currently under development with biotechnology and pharmaceutical industry collaborators to create what we believe
will be the next-generation biologic drugs with improved pharmacological properties over existing therapeutics. Our drug candidates have
resulted from our research activities or that of our collaborators and are in the development stage. As a result, we have committed a
significant amount of our resources to our research and development activities and anticipate continuing to do so for the near future.
To date, none of our drug candidates have received regulatory marketing authorization or approval in the U.S. by the Food and Drug Administration
nor in any other countries or territories by any applicable agencies. We are receiving ongoing royalties pursuant to a license of our
PolyXen technology to an industry partner. Although we hold a broad patent portfolio, the focus of our internal efforts during the three
and six months ended June 30, 2024, was on the advancement of our DNase technology.
Impact of the Global Conflicts on Our Operations
The short and long-term implications of Russia’s
invasion of Ukraine and conflict in the Middle East are difficult to predict at this time. The imposition of current and future sanctions
and counter sanctions may have an adverse effect on the economic markets generally and could impact our business, financial condition,
and results of operations.
RESULTS OF OPERATIONS
Comparison of Quarter Ended June 30, 2024
and 2023
The comparison of our historical results of operations
for the fiscal quarter ended June 30, 2024 to the fiscal quarter ended June 30, 2023 is as follows:
Description | |
Quarter Ended June 30, 2024 | | |
Quarter Ended June 30, 2023 | | |
Increase (Decrease) | | |
Percentage Change | |
Revenues: | |
| | | |
| | | |
| | | |
| | |
Royalty revenue | |
$ | 726,404 | | |
$ | 651,005 | | |
$ | 75,399 | | |
| 11.6 | |
Operating costs and expenses: | |
| | | |
| | | |
| | | |
| | |
Research and development | |
| (933,771 | ) | |
| (903,243 | ) | |
| 30,528 | | |
| 3.4 | |
General and administrative | |
| (1,130,029 | ) | |
| (945,950 | ) | |
| 184,079 | | |
| 19.5 | |
Total operating costs and expenses | |
| (2,063,800 | ) | |
| (1,849,193 | ) | |
| 214,607 | | |
| 11.6 | |
Loss from operations | |
| (1,337,396 | ) | |
| (1,198,188 | ) | |
| 139,208 | | |
| 11.6 | |
Other income (expense): | |
| | | |
| | | |
| | | |
| | |
Other (expense) income | |
| (21 | ) | |
| 21,122 | | |
| (21,143 | ) | |
| (100.1 | ) |
Interest income, net | |
| 63,447 | | |
| 126,103 | | |
| (62,656 | ) | |
| (49.7 | ) |
| |
| | | |
| | | |
| | | |
| | |
Net loss | |
$ | (1,273,970 | ) | |
$ | (1,050,963 | ) | |
$ | (223,007 | ) | |
| 21.2 | |
Revenue
Revenue for the three months ended June 30, 2024
increased by approximately $0.1 million, or 11.6%, to approximately $0.7 million from approximately $0.7 million for the three months
ended June 30, 2023. This increase represents an increase in royalty revenue related to our sublicense agreement with Takeda Pharmaceuticals
Co. Ltd. (“Takeda”) as compared to the same period in 2023.
Research and Development Expenses
Research & development
(“R&D”) expenses for the three months ended June 30, 2024 was relatively flat with the comparable quarter in 2023.
The table below sets forth the R&D costs incurred by the Company by category of expense for the quarters ended June 30, 2024 and
2023:
| |
Quarter Ended, | |
Category of Expense | |
June 30, 2024 | | |
June 30, 2023 | |
Outside services and contract research organizations | |
$ | 474,850 | | |
$ | 731,045 | |
Personnel costs | |
| 415,807 | | |
| 126,957 | |
Share-based expense | |
| (3,804 | ) | |
| 13,778 | |
Other | |
| 46,918 | | |
| 31,463 | |
Total research and development expense | |
$ | 933,771 | | |
$ | 903,243 | |
The decrease in outside
services and contract research organizations expense was primarily due to decreased spending in connection with our pre-clinical and process
development efforts related to our DNase platform. The increase in personnel costs is due to certain severance and benefits expensed in
connection with a separation agreement entered into during the second quarter of 2024 with our former Chief Scientific Officer.
General and Administrative Expenses
General and administrative expenses for the three
months ended June 30, 2024 increased by approximately $0.2 million, or 19.5%, to approximately $1.1 million from approximately $0.9 million
in the comparable quarter in 2023. The increase was primarily due to certain severance and benefits expensed in connection with a separation
agreement entered into during the second quarter of 2024 with our former Chief Executive Officer. This increase was partially offset by
general decreases in accounting and legal fees during the three months ended June 30, 2024 compared to the same period in 2023.
Other (Expense) Income
Other expense was $21 for the three months ended
June 30, 2024 compared to approximately $21,000 of other income for the comparable quarter in 2023. This decrease in other income was
primarily related to fees associated with the Pharmsynthez Loan recognized during the three months ended June 30, 2023. There were no
similar fees received in the same period in 2024.
Interest Income
Interest income, net decreased to approximately
$63,000 during the three months ended June 30, 2024 as compared to approximately $126,000 for the same period in the prior year. This
decrease was primarily due to lower average invested funds during the three months ended June 30, 2024 compared to the same period in
2023 as well as a decrease in interest income on the Pharmsynthez Loan.
Comparison of Six Months Ended June 30,
2024 and 2023
The comparison of our historical results of operations
for the six months ended June 30, 2024 to the six months ended June 30, 2023 is as follows:
Description | |
Six Months Ended June 30, 2024 | | |
Six Months Ended June 30, 2023 | | |
Increase (Decrease) | | |
Percentage Change | |
Revenues: | |
| | | |
| | | |
| | | |
| | |
Royalty revenue | |
$ | 1,237,221 | | |
$ | 1,256,849 | | |
$ | (19,628 | ) | |
| (1.6 | ) |
Operating costs and expenses: | |
| | | |
| | | |
| | | |
| | |
Research and development | |
| (1,878,092 | ) | |
| (1,498,519 | ) | |
| 379,573 | | |
| 25.3 | |
General and administrative | |
| (1,964,939 | ) | |
| (1,871,693 | ) | |
| 93,246 | | |
| 5.0 | |
Total operating costs and expenses | |
| (3,843,031 | ) | |
| (3,370,212 | ) | |
| 472,819 | | |
| 14.0 | |
Loss from operations | |
| (2,605,810 | ) | |
| (2,113,363 | ) | |
| 492,447 | | |
| 23.3 | |
Other income (expense): | |
| | | |
| | | |
| | | |
| | |
Other income | |
| 31 | | |
| 25,642 | | |
| (25,611 | ) | |
| (99.9 | ) |
Interest income, net | |
| 136,696 | | |
| 180,204 | | |
| (43,508 | ) | |
| (24.1 | ) |
| |
| | | |
| | | |
| | | |
| | |
Net loss | |
$ | (2,469,083 | ) | |
$ | (1,907,517 | ) | |
$ | 551,566 | | |
| 29.4 | |
Revenue
Revenue for the six months ended June 30, 2024
was relatively flat with the six months ended June 30, 2023.
Research and Development Expenses
R&D expenses for the six months ended June
30, 2024 increased by approximately $0.4 million, or 25.3%, to approximately $1.9 million from approximately $1.5 million in the comparable
period in 2023. The table below sets forth the R&D costs incurred by the Company by category of expense for the six months ended June
30, 2024 and 2023:
| |
Six Months Ended, | |
Category of Expense | |
June 30, 2024 | | |
June 30, 2023 | |
Outside services and contract research organizations | |
$ | 1,220,522 | | |
$ | 1,154,912 | |
Personnel costs | |
| 561,612 | | |
| 251,750 | |
Share-based expense | |
| 11,433 | | |
| 27,466 | |
Other | |
| 84,525 | | |
| 64,391 | |
Total research and development expense | |
$ | 1,878,092 | | |
$ | 1,498,519 | |
The increase in outside services and contract research organizations
expense was primarily due to increased spending in connection with our pre-clinical development efforts offset by lower process development
efforts related to our DNase platform. The increase in personnel costs is due to certain severance and benefits expensed in connection
with a separation agreement entered into during the second quarter of 2024 with our former Chief Scientific Officer.
General and Administrative Expenses
General and administrative expenses for the six
months ended June 30, 2024 increased by approximately $0.1 million, or 5.0%, to approximately $2.0 million from approximately $1.9 million
in the comparable period in 2023. The increase was primarily due to certain severance and benefits expensed in connection with a separation
agreement entered into during the second quarter of 2024 with our former Chief Executive Officer. This increase was partially offset by
general decreases in accounting and legal fees during the six months ended June 30, 2024 compared to the same period in 2023.
Other Income
Other income was $31 for the six months ended
June 30, 2024 compared to approximately $26,000 of other income for the six months ended June 30, 2023. This decrease in other income
was primarily related to fees associated with the Pharmsynthez Loan recognized during the six months ended June 30, 2023 for which there
were no similar fees received in the same period in 2024.
Interest Income
Interest income decreased to approximately $137,000
during the six months ended June 30, 2024 as compared to approximately $180,000 for the same period in the prior year. This decrease was
primarily due to lower average invested funds during the six months ended June 30, 2024 compared to the same period in 2023 as well as
a decrease in interest income received on the Pharmsynthez Loan.
Liquidity and Capital Resources
We incurred a net loss
of approximately $2.5 million for the six months ended June 30, 2024. We had an accumulated deficit of approximately $195.7 million at
June 30, 2024, as compared to an accumulated deficit of approximately $193.2 million at December 31, 2023. Working capital was approximately
$6.4 million at June 30, 2024, and approximately $8.8 million at December 31, 2023. During the six months ended June 30, 2024, our working
capital decreased by approximately $2.3 million primarily due to our net loss for the six months ended June 30, 2024.
Our principal source
of liquidity consists of cash. At June 30, 2024, we had approximately $7.3 million in cash and approximately $1.6 million in current liabilities.
At December 31, 2023, we had approximately $9.0 million in cash and approximately $0.8 million in current liabilities. We have historically
relied upon sales of our equity securities to fund our operations.
We evaluate whether there
are conditions or events, considered in the aggregate, that raise substantial doubt about our ability to continue as a going concern within
one year after the date that the financial statements are issued. We have incurred substantial losses since our inception, and we expect
to continue to incur operating losses in the near-term. The Company believes that its existing resources will be adequate to fund the
Company’s operations for a period of at least twelve months from the date of the issuance of these financial statements. However,
we anticipate we will need additional capital in the long-term to pursue our business initiatives. While the Company believes it has access
to capital resources through possible public or private equity offerings, debt financings, corporate collaborations, related party funding,
or other means to continue as a going concern, the terms, timing and extent of any future financing will depend upon several factors,
including the achievement of progress in our clinical development programs, our ability to identify and enter into licensing or other
strategic arrangements, our continued listing on Nasdaq, and factors related to financial, economic, geo-political, industry and market
conditions, many of which are beyond our control. The capital markets for the biotech industry can be highly volatile, which make the
terms, timing and extent of any future financing uncertain.
Cash Flows from Operating Activities
Cash flows used in operating activities for the
six months ended June 30, 2024 totaled approximately $1.7 million, which was primarily due to our net loss for the period, partially offset
by non-cash charges associated with share-based expense and an increase in current liabilities during the period. Cash flows used in operating
activities for the six months ended June 30, 2023 totaled approximately $2.4 million, which was primarily due to our net loss for the
period as well as advance payments made in accordance with our statement of work with Catalent, partially offset by cash received from
the repayment of the Pharmsynthez Loan. In addition, current liabilities decreased during the six months ended June 30, 2023.
Cash Flows from Investing Activities
There were no cash flows from investing activities
for the six months ended June 30, 2024 and 2023.
Cash Flow from Financing Activities
There were no cash flows from financing activities
for the six months ended June 30, 2024 and 2023.
Contractual Obligations and Commitments
As of June 30, 2024, there were no material changes
in our contractual obligations and commitments from those disclosed in our Annual Report on Form 10-K for the year ended December 31,
2023, filed with the SEC on March 21, 2024, as amended on April 26, 2024.
Off Balance Sheet Arrangements
We do not have any off-balance sheet financing
arrangements that have or are reasonably likely to have a current or future material effect on our financial condition, change in financial
condition, revenues or expenses, results of operations, liquidity, capital expenditures, or capital resources.
Recent Accounting Standards
See Note 3 in our Annual Report on Form 10-K for
the year ended December 31, 2023, filed with the SEC on March 21, 2024, as amended on April 26, 2024, for a discussion of recent accounting
standards.
Critical Accounting Estimates
Our condensed consolidated financial statements
are prepared in accordance with U.S. generally accepted accounting principles. The preparation of our condensed consolidated financial
statements requires us to make estimates, assumptions and judgments that affect the reported amounts of assets, liabilities, revenue,
costs and expenses. We base our estimates and assumptions on historical experience and other factors that we believe to be reasonable
under the circumstances. We evaluate our estimates and assumptions on an ongoing basis. The result of these evaluations forms the basis
for making judgments about the carrying values of assets and liabilities and the reported amount of expenses that are not readily apparent
from other sources. Because future events and their effects cannot be determined with certainty, actual results and outcomes may differ
materially from our estimates, judgments and assumptions. There have been no material changes in our critical accounting estimates from
those disclosed in our Annual Report on Form 10-K for the year ended December 31, 2023, filed with the SEC on March 21, 2024,
as amended on April 26, 2024.
ITEM 3 – QUANTITATIVE AND QUALITATIVE
DISCLOSURES ABOUT MARKET RISK
We are not required to provide the information
required by this Item because we are a “smaller reporting company” (as defined in Rule 12b-2 of the Exchange Act).
ITEM 4 – CONTROLS AND PROCEDURES
Evaluation of Disclosure Controls and Procedures
Our management, with the participation of our
Interim Chief Executive Officer (principal executive officer) and Chief Financial Officer (principal financial officer), evaluated the
effectiveness of our disclosure controls and procedures as defined in Rules 13a-15(e) or 15d-15(e) under the Exchange Act, as of the end
of the period covered by this Quarterly Report.
Based on this evaluation, our management, including
our Interim Chief Executive Officer and Chief Financial Officer, concluded that as of the end of the period covered by this Quarterly
Report, our disclosure controls and procedures are designed at a reasonable assurance level and are effective to provide reasonable assurance
that information we are required to disclose in reports that we file or submit under the Exchange Act is recorded, processed, summarized,
and reported within the time periods specified in the SEC’s rules and forms, and that such information is accumulated and communicated
to our management, including our Interim Chief Executive Officer and Chief Financial Officer, as appropriate, to allow timely decisions
regarding required disclosure.
Changes in Internal Control over Financial
Reporting
There were no changes in our internal control
over financial reporting that occurred during the period covered by this Quarterly Report that would 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 subject to any material legal
proceedings, nor, to our knowledge, is any material legal proceeding threatened against us. From time to time, we may be a party to certain
legal proceedings, incidental to the normal course of our business. While the outcome of these legal proceedings cannot be predicted with
certainty, we do not expect that these proceedings will have a material effect upon our financial condition or results of operations.
ITEM 1A – RISK FACTORS
There have been no material changes to the risk
factors previously disclosed in our Annual Report on Form 10-K for the year ended December 31, 2023 filed with the SEC on March 21, 2024,
as amended on April 26, 2024.
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
During the quarter ended June 30, 2024, no director
or officer adopted or terminated any Rule 10b5-1 trading arrangement or non-Rule 10b5-1 trading arrangement, as each term is defined in
Item 408(a) of Regulation S-K.
ITEM 6 – EXHIBITS
The following exhibits are incorporated herein
by reference or filed as part of this report.
EXHIBIT NUMBER |
DESCRIPTION |
|
|
10.1* |
Confidential Separation Agreement and General Release, dated June 19, 2024, between Jeffrey Eisenberg and Xenetic Biosciences, Inc. |
10.2* |
Confidential Separation Agreement and General Release, dated June 19, 2024, between Curtis Lockshin and Xenetic Biosciences, Inc. |
10.3* |
Amendment to Employment Agreement, dated June 18, 2024, between James F. Parslow and Xenetic Biosciences, Inc. |
31.1* |
Certification of James Parslow, Interim Principal Executive Officer, pursuant to Section 302 of the Sarbanes-Oxley Act of 2002 |
31.2* |
Certification of James Parslow, Principal Financial Officer, pursuant to Section 302 of the Sarbanes-Oxley Act of 2002 |
32.1** |
Certification of James Parslow, Interim Principal Executive Officer and Principal Financial Officer, pursuant to Section 906 of the Sarbanes-Oxley Act of 2002 |
101* |
The following financial statements from the Company’s Quarterly Report on Form 10-Q for the quarter ended June 30, 2024, formatted in inline XBRL, include: (i) Condensed Consolidated Balance Sheets, (ii) Condensed Consolidated Statements of Operations, (iii) Condensed Consolidated Statements of Changes in Stockholders’ Equity, (iv) Condensed Consolidated Statements of Cash Flows and (v) the Notes to the Condensed Consolidated Financial Statements. |
104* |
Cover Page Interactive Data File (formatted in inline XBRL and included in Exhibit 101) |
|
|
* |
Filed herewith. |
** |
Exhibit 32.1 is being furnished and shall not be deemed to be "filed" for purposes of Section 18 of the Securities Exchange Act of 1934, as amended, or otherwise subject to the liability of that section, nor shall such exhibits be deemed to be incorporated by reference in any registration statement or other document filed under the Securities Act of 1933, as amended or the Securities Exchange Act of 1934, as amended, except as otherwise stated in such filing. |
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.
|
|
|
Xenetic Biosciences, Inc. |
|
|
|
|
|
|
|
|
August 13, 2024 |
|
By: |
/S/ JAMES PARSLOW |
|
|
|
James Parslow
Interim Chief Executive Officer and Chief Financial Officer
(Principal Executive, Principal Financial Officer and Principal Accounting Officer) |
Exhibit 10.1
Execution Version
CONFIDENTIAL SEPARATION AGREEMENT & GENERAL RELEASE
THIS CONFIDENTIAL SEPARATION
AGREEMENT & GENERAL RELEASE (“Agreement”) is made and entered into by and between Jeffrey Eisenberg ( “Executive”),
and Xenetic Biosciences, Inc. (the “Company”). Executive and Company are collectively referred to herein as the “Parties.”
I.Recitals
| A. | Executive is currently employed by Company on an at will basis pursuant to the terms of that certain Amended
and Restated Employment Agreement, by and between the Executive and Company, dated October 26, 2017 (the “Employment Agreement”); |
| | |
| B. | On May 16, 2024, the Board of Directors (the “Board”) of the Company approved the termination
of Executive from all roles in the Company, effective immediately, and recommended that Executive tender his resignation from the Board; |
| | |
| C. | Executive’s last date of employment is May 16, 2024 (the “Separation Date”); |
| | |
| D. | Executive acknowledges that from and after the Separation Date, Executive has no authority to, and shall
not, represent himself as an employee or agent of Company; |
| | |
| E. | Executive represents and warrants that he does not have any claims or charges pending against Company
with any court, tribunal or administrative agency; |
| | |
| F. | Executive and Company desire to enter into this Agreement related to Executive’s separation from
Company; and |
| | |
| G. | Nothing within this Agreement shall constitute an admission of any liability or wrongdoing by Company,
which expressly denies any liability or wrongdoing. |
II.General Provisions
The Parties hereby agree as follows:
The Recitals contained in Section I are incorporated herein
and made a part hereof.
| B. | Release and Discharge by Executive |
1.The
term “Released Parties” includes the Company, Insperity PEO Services, L.P. (“Insperity”) and their
respective current or former officers, directors, shareholders, investors, owners, partners, employees, associates, servants, agents,
managing agents, partnerships, trustees, predecessors, successors, assigns, affiliates, parent corporations, and/or subsidiaries; and/or
any other entity or company operated, affiliated with, controlled by, or under common control with any one of the foregoing; and each
of their predecessors, successors, assigns, affiliates, partnerships, parent corporations, subsidiaries (whether or not wholly owned),
divisions, business units by or through which Company does business, partners (including partners of partnerships and affiliates), related
entities, all of their trustees, directors, officers, attorneys, insurers, reinsurers, accountants, lenders, investors, agents, servants,
representatives, employees and former employees (in their respective capacities as such, in their individual and personal capacities,
and in any and all other capacities); and all other related entities of any type, scope or existence, of each of the foregoing. Any reference
to the “Released Parties” includes one or more or all of them.
2.The term “Released
Claims” means and shall include any and all claims, actions, and causes of action, liens, debts, liabilities, demands, obligations,
contracts or commitments, suits, debts, accounts, covenants, disputes, controversies, agreements, promises, acts, costs and expenses,
damages, and executions, of whatever kind or nature, including without limitation any statutory, civil, common law or administrative
claim, such as but not limited to the following: claims under Title VII of the Civil Rights Act of 1964 and/or 1991, Section 1981 of
the Civil Rights Act of 1866, the Americans with Disabilities Act of 1990, the Family and Medical Leave Act of 1990, the Fair Labor Standards
Act of 1938, the Executive Retirement Income Security Act of 1974, the National Labor Relations Act of 1935, the Equal Pay Act of 1963,
the Consolidated Omnibus Budget Reconciliation Act of 1985 (“COBRA”), the Immigration Reform and Control Act of 1986,
the Occupational Safety and Health Act of 1970, the Worker Adjustment and Retraining Notification Act of 1988, the Dodd–Frank Wall
Street Reform and Consumer Protection Act of 2010, the Health Insurance Portability and Accountability Act of 1996, the Vocational Rehabilitation
Act of 1973 (29 U.S.C. § 701 et seq.), or any related state law or local ordinance related to employment or employment discrimination;
claims for disputed wages and penalties under federal or state law; claims for compensation, severance, employee benefits and vacation
or sick pay; attorneys’ fees, costs, expenses and expert witness fees and expenses; tort damages or personal injury damages; breach
of implied or express contract; retaliation, failure to accommodate; failure to engage in an interactive process; wrongful termination
in violation of public policy; breach of fiduciary duty; declaratory relief; injunctive relief; public policy breach; intentional or
negligent infliction of emotional distress; breach of the Employment Agreement or any other employment contract (whether express, implied
in law or fact, oral or written); breach of implied covenant of good faith and fair dealing; interference with contract; intentional
or negligent interference with prospective economic advantage; intentional or negligent misrepresentation, promissory fraud, or fraud;
conversion; defamation; libel or slander; discrimination, retaliation, harassment or hostile work environment on the basis of any statutorily
protected class including but not limited to disability or age, or failure to prevent such discrimination, retaliation, harassment or
hostile work environment; negligent hiring; constructive discharge; disparagement of any kind or nature; invasion of privacy; civil assault;
malicious prosecution; abuse of process; declaratory or injunctive relief, or in any other type of action or proceeding, whether known
or unknown, suspected or unsuspected, fixed or contingent, at law or in equity, which Executive ever had or held, now has or holds, or
hereafter can, shall, or may have or hold at any time in the future, in any capacity, individually or as a member of a class, collective
or representative action, relator-employee, or action for public benefit with respect to Executive’s employment with Company, or
the termination thereof, the subject matter of this Agreement, or any other matters with, by or between Company, or the Released Parties
and Executive, or by any one or more of the Released Parties against Executive, at any time prior to and through the Effective Date of
this Agreement. The Released Claims expressly exclude claims that may not be waived under applicable law at the time the Agreement is
executed by Executive.
3.
In consideration of the terms and provisions of the Agreement, Executive shall and does hereby and forever fully, finally and forever
generally remise, release, waive and discharge Company and the Released Parties from any and all known or unknown, suspected or unsuspected,
fixed or contingent claims, rights, actions and causes of action, including but not limited to the Released Claims, at law or in equity,
which Executive ever had or held, now has or holds, or hereafter can, shall, or may have or hold against Company or any or all of the
Released Parties based on any occurrences, transactions, events, acts, or omissions of any kind whatsoever from any time prior to and
through the Effective Date of the Agreement.
4.
Nothing in this Agreement prohibits Executive from: (a) filing an administrative charge of discrimination or an administrative
charge within the jurisdiction of the National Labor Relations Board (“NLRB”) or Equal Employment Opportunity Commission
(“EEOC”) or similar state or local civil rights agencies; (b) communicating directly with the U.S. Securities and Exchange
Commission (“SEC”) about a possible securities law violation which Executive is not required to report or disclose
to the Company; or (c) filing a charge or communicating with any other federal, state or local government office, official or agency concerning
matters relevant to such governmental office or agency. Executive promises never to seek or accept any damages, remedies, or other relief,
for Executive personally (any right to which Executive hereby waives and promises never to accept) with respect to any claim released
hereunder, in any proceeding including, but not limited to, any EEOC or NLRB proceeding, other than a benefit or remedy pursuant to Section
922 of the Dodd-Frank Wall Street Reform or the Consumer Protection Act or as otherwise required by law. Notwithstanding the foregoing,
this Agreement does not limit Executive’s right to receive an award for information provided to the SEC.
C.Payment
and Other Consideration
1.Consideration.
a)In consideration
of the releases and promises set forth in this Agreement:
i.the
Company shall pay Executive the sum of $420,420, representing an amount equal to one times Executive’s Base Salary (as defined in
the Employment Agreement), less all applicable withholdings, deductions and taxes as required by law, payable in one lump sum within thirty
days after the Effective Date (as defined in Section X below) (the “Separation Payment”);
ii.
all of the unvested stock options held by Executive as of the Separation Date as listed on Exhibit A shall fully vest on
the Separation Date and not be subject to forfeiture; and
iii.
the Company shall reimburse Executive for reasonable legal fees in an amount not to exceed $10,000 that the Executive incurs in
connection with the negotiation of this Agreement, subject to the delivery of appropriate documentation thereof and
provided that the Executive shall submit invoices to the Company within thirty (30) days of incurrence of the expense.
b)
The Separation Payment will be reported on an IRS Form W-2. Executive understands, acknowledges and agrees that the Separation
Payment will be paid by the Company, provided: (a) Executive is not in breach of any term, condition, warranty, representation,
covenant or provision of this Agreement, (b) Executive does not revoke the Agreement within the Revocation Period described in Section
IX below; and (c) Executive first returns a signed and dated copy of this Agreement to the Company. Executive acknowledges that the Separation
Payment and other consideration to be provided under the terms of this Agreement is not an entitlement and shall serve as good and sufficient
consideration of the promises made by Executive herein. Executive further acknowledges that the Separation Payment to be paid under this
Agreement is due solely from the Company and that Insperity has no obligation to pay the Separation Payment even though its payment may
be processed through Insperity.
c)
Executive acknowledges and agrees that the Compensation Committee of the Board of the Company has not established an annual bonus
target for Executive or any related performance goals for an annual bonus for Executive and, therefore the pro rata portion of the annual
performance-based cash bonus for fiscal year 2024 owed to Executive pursuant to Section 7(d)(ii) of the Employment Agreement shall be
deemed to be $0.
2.
Outstanding Equity Awards. The Executive’s outstanding equity awards as of the Separation Date are set forth on Exhibit
A to this Agreement. Executive understands and agrees that except as otherwise specified herein, treatment of the Executive’s
outstanding equity awards will be governed by the terms and conditions of the applicable award agreements and the Xenetic Biosciences,
Inc. Amended and Restated Equity Incentive Plan. Per the terms of the applicable stock option award agreements, all vested stock options
as of the Separation Date may be exercised at any time during the three or twelve month period, as applicable, following the Separation
Date, as set forth on Exhibit A.
3.
Final Paycheck and Expenses. Regardless of whether the Executive signs this Agreement, the Employee acknowledges and agrees
that the Company has (a) paid the Executive for any accrued but unpaid portion of the Executive’s Base Salary through the Separation
Date, (b) reimbursed the Executive for reasonable out-of-pocket business expenses that were appropriately incurred by the Executive prior
to the Separation Date in furtherance of the business of the Company, subject to the Company’s applicable business expense reimbursement
policy, and (c) paid the Executive an amount equal to any accrued but unused vacation pay as of the Separation Date.
4.
Benefits. Following the Separation Date, Executive will be eligible to continue Executive’s participation in the Company’s
group health benefit plans, such as they may exist from time-to-time, if and to the extent Executive was enrolled in such plans as of
the Separation Date. Such benefits continuation will be provided concurrent with and in accordance with the terms of COBRA and/or applicable
state/local benefits continuation laws. If Executive elects to receive such continued healthcare coverage, the Company shall reimburse
Executive for the premium for Executive and Executive’s covered dependents, less the amount of Executive’s monthly premium
contributions for such coverage prior to termination, for the period commencing on the first day following the Separation Date through
the earlier of (i) the last day of the month during the first twelve months following the Separation Date and (ii) the date Executive
and Executive’s covered dependents, if any, become eligible for healthcare coverage under another employer’s plan(s). Executive
shall notify the Company immediately if Executive becomes covered by a group health plan of a subsequent employer. If Executive does not
elect COBRA, the Company has no obligation to pay any form of insurance coverage after the Separation Date. Executive further agrees and
acknowledges that, except as specifically provided in this Agreement, Executive’s participation in all Company employee benefit
plans shall terminate as of the Separation Date.
5.
No Other Payments. Executive expressly acknowledges and agrees that this Agreement provides Executive with compensation
to which Executive would not otherwise be entitled. Executive acknowledges and agrees that Executive has been paid all final wages owed
to Executive by Company, and that these monies were due and owing to Executive regardless of whether Executive chooses to execute the
Agreement or not. Other than payment of the Separation Payment and other payments and additional benefits provided hereunder, Executive
acknowledges that no other payments, including but not limited to those for back pay, front pay, salary, benefits, bonus, vacation or
sick pay, civil or statutory penalties, general or compensatory damages, interest, or costs for the period of time Executive was employed
by the Company, or for any other period, are due and owing to Executive from Company or the Released Parties.
D.Survival
of Covenants
Executive agrees that the
covenants with respect to non-competition, non-solicitation, confidentiality, inventions and return of property set forth in Sections
9 through 13 in the Employment Agreement shall survive the separation of Executive’s employment with the Company and remain in
full force and effect; provided, however, that for the sake of clarity, “Competing Products” as defined in Section 9(c)(i)
of the Employment Agreement shall be amended and restated to mean: “any product, process, or service of any person or organization
other than the Company, in existence or under development, which is identical to, substantially the same as, or an adequate substitute
for the Deoxyribonuclease (DNase) platform and the PolyXen technology.”
E.Confidentiality
and Nondisclosure of this Agreement
1.
Executive acknowledges that the confidentiality and non-disclosure of all terms and conditions of this Agreement is an integral
part of the agreement to pay severance benefits to Executive, and was a material inducement for Company to enter into this Agreement.
2.
Executive agrees that Executive will maintain the terms of this Agreement in complete confidentiality. Executive shall make no
comments, to any person or entity, including but not limited to the media, friends, co-workers, or former co-workers from Company regarding
the Agreement, including the Separation Payment. For purposes of this Agreement, the word “comments” includes any form of
communication, whether oral, written, electronic or otherwise. Executive acknowledges that these nondisclosure provisions are an integral
part of this Agreement. Executive may disclose the terms of this Agreement to Executive’s spouse, attorneys and tax preparer/accountants
provided that such disclosure to the attorneys and tax preparer/accountants is made for the purposes of the attorneys and tax preparer/accountants
providing legal and/or tax advice and provided that Executive’s spouse, Executive’s attorneys and tax preparer/accountants
agree to be bound by this confidentiality section. Executive, if required by a Court order or subpoena, or as otherwise permitted by law,
may disclose the terms of this Agreement without breaching these confidentiality provisions provided that in the event a demand is made
upon Executive for the disclosure of the terms of the Agreement, Executive shall, within 48 hours immediately notify the Company of the
demand, so that Company may have sufficient time to seek any necessary orders, including a protective order, or to otherwise participate
in the tribunal’s determination of the issue.
F.Waiver
of Reemployment
Executive agrees that by executing
this Agreement, Executive waives and releases forever any right or rights Executive might have to seek or obtain employment, reemployment,
or reinstatement with Company or the Released Parties.
G.Return
of Company Property, Log Ins and Passwords
In order to be eligible to
receive the Separation Payment, immediately prior to the Effective Date, Executive must return to Company all Company property and all
Company confidential information in Executive’s possession, and Executive must provide to Company all log ins and passwords to any
software, website, application or program, which Executive maintained and used as part of the performance of Executive’s job duties
and responsibilities.
III. Warranty of Capacity to Execute Agreement
Executive represents and warrants
that no other person or entity has or has had any interest in the claims, demands, obligations or causes of action referred to in this
Agreement; that Executive has the sole and exclusive right to receive sums specified in it; that Executive has not sold, assigned, transferred,
conveyed or otherwise disposed of any of the claims, demands, obligations or causes of action referred to in this Agreement; and that
Executive has the mental capacity to understand and execute the terms and conditions of the Agreement.
IV.
Disclaimer of Liability
Executive agrees to indemnify
and hold harmless Company and the Released Parties from any and all claims or liens presently existing against the Separation Payment
hereby by any person, entity or corporation, as well as any attorneys’ fees and costs incurred in representation of Company or the
Released Parties in litigation concerning any claims or liens, including but not limited to any claims or liens for attorneys’ fees
and costs.
V.
Entire Agreement & Successors in Interest
Except as otherwise provided
herein, Executive agrees that this Agreement contains the entire agreement between Executive and Company with respect to the matters set
forth in it, and shall be binding upon and inure to the benefit of Executive’s executors, administrators, personal representatives,
heirs, successors and assigns. There are no other understandings or agreements, verbal or otherwise, in relation thereto between the Parties,
except as herein expressly set forth. There have been no representations not set forth herein that Executive has relied upon when entering
into this Agreement. Executive agrees that should any provision of this Agreement require interpretation or construction that all Parties
have participated in the drafting of this document and no presumption regarding construing the document against one Party shall apply.
VI.
Severability
If any provision in this Agreement
is found to be unenforceable, all other provisions will remain fully enforceable. The covenants set forth in this Agreement shall be considered
and construed as separate and independent covenants. Should any part or provision of any provision of this Agreement be held invalid,
void or unenforceable in any court of competent jurisdiction, such invalidity, voidness or unenforceability shall not render invalid,
void or unenforceable any other part or provision of this Agreement.
VII.
Governing Law
This Agreement is entered
into in the State of Florida, and shall be construed and interpreted in accordance with its laws. The Parties agree that the proper and
appropriate venue for any action arising from this Agreement shall be any court of competent jurisdiction in Miami-Dade County, Florida.
VIII.
Additional Documents
Executive agrees to cooperate
fully, and execute any and all supplementary documents, and take all additional actions which may be necessary or appropriate to give
full force and effect to the basic terms and intent of this Agreement.
IX.
Acknowledgement of Voluntariness and Opportunity for Review and Revocation
1.Executive
acknowledges that (a) Executive knowingly and voluntarily enters into this Agreement with the purpose of waiving any right and releasing
any claims under the Age Discrimination in Employment Act of 1967, 29 U.S.C. § 621, et seq. (“ADEA”);
(b) Executive was given a period of up to twenty-one (21) days within which to review and consider this Agreement; (c) Executive understood
Executive could use as much of said 21-day period as Executive desired; (d) Executive was encouraged by Company to consult with a lawyer,
at Executive’s own expense; (e) if Executive decided not to use the 21-day period, Executive is signing this Agreement voluntarily
and of Executive’s own free will; and (f) this Agreement is not final and binding until the seven-day period of revocation, described
in the following sentences of this Section of the Agreement, has expired. Executive understands that Company would not have given Executive
the special payments or benefits Executive is getting in exchange for this Agreement but for Executive’s promises and representations
Executive is making by signing it.
2.Executive acknowledges
that Executive may revoke Executive’s waiver of the rights and release of any ADEA (age discrimination) claims covered by this
Agreement, by delivering written notice of Executive’s revocation of this Agreement to Jim Parslow at j.parslow@xeneticbio.com,
no later than the close of business on the seventh (7th) calendar day after the date on which Executive signed this Agreement (the “Revocation
Period”). The written notice of revocation must state: “I HEREBY REVOKE MY ACCEPTANCE OF THE CONFIDENTIAL SEPARATION
AGREEMENT AND GENERAL RELEASE.” If the Agreement is revoked in a timely manner, this Agreement shall not be effective, and Executive
shall not receive the Separation Payment as described in Section II.C. herein.
X.
Effectiveness and Electronic Signatures
This Agreement shall become
effective following execution by all the Parties (“Effective Date”). This Agreement may be executed via manual signature
or electronic signature. “Electronic signature” means (a) the signing party’s manual signature, converted by the signing
party to facsimile or industry-accepted digital form (such as a .pdf file) and received from the signing party’s customary email
address, customary facsimile number, or other mutually agreed-upon authenticated source; or (b) the signing party’s digital signature
executed using a mutually agreed-upon digital signature service provider, such as DocuSign or Adobe sign, and digital signature process.
Each Party to this Agreement (i) agrees that it will be bound by its own electronic signature, (ii) accepts the electronic signature of
each other Party to this Agreement, and (iii) agrees that such electronic signatures shall be the legal equivalent of manual signatures.
This Agreement may be so executed in counterparts, each of which will be considered an original and all such counterparts will be considered
and constitute one and the same agreement.
XI.
Disparaging Statements
Neither the Executive nor
the Company shall make any remarks or statements, either publicly or privately, orally or in writing, that are disparaging of the other
party. The Executive shall not make any remarks or statements, either publicly, orally or in writing that are disparaging of the Company’s
actual or prospective business and/or, in such capacities, current or former employees, officers, directors, trade partners, vendors,
suppliers, or customers of the Company, either individually or collectively. For the avoidance of doubt, this includes remarks or statements,
public or private, made via electronic mail, blogs, social media (such as, Facebook, Twitter or X, LinkedIn, Instagram or any other similar
platform). This provision is subject to each party’s
legally protected rights to communicate with governmental bodies and agencies and to engage in otherwise legally protected activity.
[remainder of page intentionally blank]
EMPLOYEE: |
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/s/ Jeffrey
Eisenberg |
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Jeffrey
Eisenberg |
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Date: June 19, 2024 |
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COMPANY: |
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Xenetic Biosciences, Inc. |
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By: |
/s/ James Parslow |
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Name:
James Parslow |
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Title: Interim Chief Executive Officer and Chief Financial Officer |
Date: June 19, 2024 |
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[Signature page to Separation
and Release Agreement]
Exhibit A
Xenetic Biosciences, Inc.
Jeffrey Eisenberg – Outstanding Equity as
of May 16, 2024
Date of
Grant |
Shares |
Exercise
Price |
Expiration Date |
Total
Vested |
Total
Unvested |
Vesting |
Exercisability post termination |
Stock Options |
12/2/2016 |
1,917 |
$ 409.20 |
12/2/2026 |
1,917 |
- |
Fully Vested |
90 days post termination date |
|
|
|
|
|
|
|
|
10/26/2017 |
1,042 |
$ 253.20 |
10/26/2027 |
1,042 |
- |
Fully Vested |
12 months post termination date |
|
|
|
|
|
|
|
|
12/4/2019 |
23,000 |
$ 13.10 |
12/4/2029 |
23,000 |
- |
Fully Vested |
12 months post termination date |
|
|
|
|
|
|
|
|
3/18/2021 |
10,000 |
$ 26.00 |
3/18/2031 |
10,000 |
- |
Fully Vested |
12 months post termination date |
|
|
|
|
|
|
|
|
3/24/2022 |
10,000 |
$ 11.20 |
3/24/2032 |
6,667 |
3,333 |
1/3rd on March 24, 2023; 2/3rds over remaining 8 quarters commencing June 24, 2023 thru March 24, 2025 |
12 months post termination date |
|
|
|
|
|
|
|
|
12/11/2023 |
20,000 |
$ 3.88 |
12/11/2033 |
- |
20,000 |
1/3rd on December 11, 2024; 2/3rds over remaining 8 quarters commencing March 11, 2025 thru Dec 11, 2026 |
12 months post termination date |
|
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|
|
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Restricted Stock Units |
10/26/2017 |
417 |
N/A |
N/A |
417 |
- |
Fully Vested |
N/A |
Exhibit 10.2
Execution Version
CONFIDENTIAL SEPARATION AGREEMENT & GENERAL RELEASE
THIS CONFIDENTIAL SEPARATION
AGREEMENT & GENERAL RELEASE (“Agreement”) is made and entered into by and between Curtis Lockshin (“Executive”),
and Xenetic Biosciences, Inc. (the “Company”). Executive and Company are collectively referred to herein as the “Parties.”
I.Recitals
| A. | Executive is currently employed by Company on an at will basis pursuant to the terms of that certain Employment
Agreement, by and between the Executive and Company, dated January 1, 2017 (the “Employment Agreement”); |
| | |
| B. | On May 16, 2024, the Board of Directors of the Company approved the termination of Executive from all
roles in the Company and all of its subsidiaries, as applicable, effective immediately; |
| | |
| C. | Executive’s last date of employment is May 16, 2024 (the “Separation Date”); |
| | |
| D. | Executive acknowledges that from and after the Separation Date, Executive has no authority to, and shall
not, represent himself as an employee or agent of Company; |
| | |
| E. | Executive represents and warrants that he does not have any claims or charges pending against Company
with any court, tribunal or administrative agency; |
| | |
| F. | Executive and Company desire to enter into this Agreement related to Executive’s separation from
Company; and |
| | |
| G. | Nothing within this Agreement shall constitute an admission of any liability or wrongdoing by Company,
which expressly denies any liability or wrongdoing. |
II.General Provisions
The Parties hereby agree as follows:
The Recitals contained in Section I are incorporated herein
and made a part hereof.
| B. | Release and Discharge by Executive |
1.The
term “Released Parties” includes Company, Insperity PEO Services, L.P. (“Insperity”) and their
respective current or former officers, directors, shareholders, investors, owners, partners, employees, associates, servants, agents,
managing agents, partnerships, trustees, predecessors, successors, assigns, affiliates, parent corporations, and/or subsidiaries; and/or
any other entity or company operated, affiliated with, controlled by, or under common control with any one of the foregoing; and each
of their predecessors, successors, assigns, affiliates, partnerships, parent corporations, subsidiaries (whether or not wholly owned),
divisions, business units by or through which Company does business, partners (including partners of partnerships and affiliates), related
entities, all of their trustees, directors, officers, attorneys, insurers, reinsurers, accountants, lenders, investors, agents, servants,
representatives, employees and former employees (in their respective capacities as such, in their individual and personal capacities,
and in any and all other capacities); and all other related entities of any type, scope or existence, of each of the foregoing. Any reference
to the “Released Parties” includes one or more or all of them.
2.The
term “Released Claims” means and shall include any and all claims, actions, and causes of action, liens, debts, liabilities,
demands, obligations, contracts or commitments, suits, debts, accounts, covenants, disputes, controversies, agreements, promises, acts,
costs and expenses, damages, and executions, of whatever kind or nature, including without limitation any statutory, civil, common law
or administrative claim, such as but not limited to the following: claims under Title VII of the Civil Rights Act of 1964 and/or 1991,
Section 1981 of the Civil Rights Act of 1866, the Americans with Disabilities Act of 1990, the Family and Medical Leave Act of 1990,
the Fair Labor Standards Act of 1938, the Executive Retirement Income Security Act of 1974, the National Labor Relations Act of 1935,
the Equal Pay Act of 1963, the Consolidated Omnibus Budget Reconciliation Act of 1985 (“COBRA”), the Immigration Reform
and Control Act of 1986, the Occupational Safety and Health Act of 1970, the Worker Adjustment and Retraining Notification Act of 1988,
the Dodd–Frank Wall Street Reform and Consumer Protection Act of 2010, the Health Insurance Portability and Accountability Act
of 1996, the Vocational Rehabilitation Act of 1973 (29 U.S.C. § 701 et seq.), or any related state law or local ordinance
related to employment or employment discrimination; claims for disputed wages and penalties under federal or state law; claims for compensation,
severance, employee benefits and vacation or sick pay; attorneys’ fees, costs, expenses and expert witness fees and expenses; tort
damages or personal injury damages; breach of implied or express contract; retaliation, failure to accommodate; failure to engage in
an interactive process; wrongful termination in violation of public policy; breach of fiduciary duty; declaratory relief; injunctive
relief; public policy breach; intentional or negligent infliction of emotional distress; breach of the Employment Agreement or any other
employment contract (whether express, implied in law or fact, oral or written); breach of implied covenant of good faith and fair dealing;
interference with contract; intentional or negligent interference with prospective economic advantage; intentional or negligent misrepresentation,
promissory fraud, or fraud; conversion; defamation; libel or slander; discrimination, retaliation, harassment or hostile work environment
on the basis of any statutorily protected class including but not limited to disability or age, or failure to prevent such discrimination,
retaliation, harassment or hostile work environment; negligent hiring; constructive discharge; disparagement of any kind or nature; invasion
of privacy; civil assault; malicious prosecution; abuse of process; declaratory or injunctive relief, or in any other type of action
or proceeding, whether known or unknown, suspected or unsuspected, fixed or contingent, at law or in equity, which Executive ever had
or held, now has or holds, or hereafter can, shall, or may have or hold at any time in the future, in any capacity, individually or as
a member of a class, collective or representative action, relator-employee, or action for public benefit with respect to Executive’s
employment with Company, or the termination thereof, the subject matter of this Agreement, or any other matters with, by or between Company,
or the Released Parties and Executive, or by any one or more of the Released Parties against Executive, at any time prior to and through
the Effective Date of this Agreement. The Released Claims expressly exclude claims that may not be waived under applicable law at the
time the Agreement is executed by Executive.
3.
In consideration of the terms and provisions of the Agreement, Executive shall and does hereby and forever fully, finally and forever
generally remise, release, waive and discharge Company and the Released Parties from any and all known or unknown, suspected or unsuspected,
fixed or contingent claims, rights, actions and causes of action, including but not limited to the Released Claims, at law or in equity,
which Executive ever had or held, now has or holds, or hereafter can, shall, or may have or hold against Company or any or all of the
Released Parties based on any occurrences, transactions, events, acts, or omissions of any kind whatsoever from any time prior to and
through the Effective Date of the Agreement.
4.
Nothing in this Agreement prohibits Executive from: (a) filing an administrative charge of discrimination or an administrative
charge within the jurisdiction of the National Labor Relations Board (“NLRB”) or Equal Employment Opportunity Commission
(“EEOC”) or similar state or local civil rights agencies; (b) communicating directly with the U.S. Securities and Exchange
Commission (“SEC”) about a possible securities law violation which Executive is not required to report or disclose
to the Company; or (c) filing a charge or communicating with any other federal, state or local government office, official or agency concerning
matters relevant to such governmental office or agency. Executive promises never to seek or accept any damages, remedies, or other relief,
for Executive personally (any right to which Executive hereby waives and promises never to accept) with respect to any claim released
hereunder, in any proceeding including, but not limited to, any EEOC or NLRB proceeding, other than a benefit or remedy pursuant to Section
922 of the Dodd-Frank Wall Street Reform or the Consumer Protection Act or as otherwise required by law. Notwithstanding the foregoing,
this Agreement does not limit Executive’s right to receive an award for information provided to the SEC.
C.Payment
and Other Consideration
1.Separation
Payment.
a)In consideration
of the releases and promises set forth in this Agreement:
i.the
Company shall pay Executive the sum of $342,342, representing an amount equal to one times Executive’s Base Salary (as defined in
the Employment Agreement), less all applicable withholdings, deductions and taxes as required by law (the “Separation Payment”),
payable in semi-monthly installments over the twelve month period following the Separation Date in accordance with the Company’s
normal payroll practices; and
ii.the
Company shall reimburse Executive for reasonable legal fees in an amount not to exceed $10,000 that the Executive incurs in connection
with the negotiation of this Agreement, subject to the delivery of appropriate documentation thereof and
provided that the Executive shall submit invoices to the Company within thirty (30) days of incurrence of the expense.
b)The
Separation Payment will be reported on an IRS Form W-2. Executive understands, acknowledges and agrees that the Separation Payment will
be paid by the Company, provided: (a) Executive is not in breach of any term, condition, warranty, representation, covenant or
provision of this Agreement, (b) Executive does not revoke the Agreement within the Revocation Period described in Section IX below; and
(c) Executive first returns a signed and dated copy of this Agreement to the Company. Executive acknowledges that the Separation Payment
to be provided under the terms of this Agreement is not an entitlement and shall serve as good and sufficient consideration of the promises
made by Executive herein. Executive further acknowledges that the Separation Payment to be paid under this Agreement is due solely from
the Company and that Insperity has no obligation to pay the Separation Payment even though its payment may be processed through Insperity.
2.
Outstanding Equity Awards. The Executive’s outstanding equity awards as of the Separation Date are set forth on Exhibit
A to this Agreement. Executive understands and agrees that treatment of the Executive’s outstanding equity awards will be governed
by the terms and conditions of the applicable award agreements and the Xenetic Biosciences, Inc. Amended and Restated Equity Incentive
Plan. Per the terms of the applicable stock option award agreements, all vested stock options as of the Separation Date may be exercised
at any time during the three month period following the Separation Date, or through the option expiration date, as applicable, as set
forth on Exhibit A. Executive’s rights with respect to any unvested stock options are forfeited effective as of the Separation
Date.
3.
Final Paycheck and Expenses. Regardless of whether the Executive signs this Agreement, the Employee acknowledges and agrees
that the Company has (a) paid the Executive for any accrued but unpaid portion of the Executive’s Base Salary through the Separation
Date, (b) reimbursed the Executive for reasonable out-of-pocket business expenses that were appropriately incurred by the Executive prior
to the Separation Date in furtherance of the business of the Company, subject to the Company’s applicable business expense reimbursement
policy, and (c) paid the Executive an amount equal to any accrued but unused vacation pay as of the Separation Date.
4.
Benefits. Following the Separation Date, Executive will be eligible to continue Executive’s participation in the
Company’s group health benefit plans, such as they may exist from time-to-time, if and to the extent Executive was enrolled in
such plans as of the Separation Date. Such benefits continuation will be provided concurrent with and in accordance with the terms of
COBRA and/or applicable state/local benefits continuation laws. If Executive elects to receive such continued healthcare coverage, the
Company shall reimburse Executive on a monthly basis for the premium for Executive and Executive’s covered dependents, less the
amount of Executive’s monthly premium contributions for such coverage prior to termination, for the period commencing on the first
day following the Separation Date through the earlier of (i) the last day of the month during the first twelve months following the Separation
Date and (ii) the date Executive and Executive’s covered dependents, if any, become eligible for healthcare coverage under another
employer’s plan(s). Executive shall notify the Company immediately if Executive becomes covered by a group health plan of a subsequent
employer. If Executive does not elect COBRA, the Company has no obligation to pay any form of insurance coverage after the Separation
Date. Executive further agrees and acknowledges that, except as specifically provided in this Agreement, Executive’s participation
in all Company employee benefit plans shall terminate as of the Separation Date.
5.No
Other Payments. Executive expressly acknowledges and agrees that this Agreement provides Executive with compensation to which Executive
would not otherwise be entitled. Executive acknowledges and agrees that Executive has been paid all final wages owed to Executive by Company,
and that these monies were due and owing to Executive regardless of whether Executive chooses to execute the Agreement or not. Other than
payment of the Separation Payment and other payments and benefits provided hereunder, Executive acknowledges that no other payments, including
but not limited to those for back pay, front pay, salary, benefits, bonus, vacation or sick pay, civil or statutory penalties, general
or compensatory damages, interest, or costs for the period of time Executive was employed by the Company, or for any other period, are
due and owing to Executive from Company or the Released Parties.
D.Survival of Covenants
Executive agrees that
the covenants with respect to non-competition, non-solicitation, confidentiality, inventions and return of property set forth in
Sections 9 through 13 in the Employment Agreement shall survive the separation of Executive’s employment with the Company and
remain in full force and effect; provided, however, that for the sake of clarity, “Competing Products” as defined in
Section 9(c)(i) of the Employment Agreement shall exclude (1) any use of polymers (including polysialic acid or PSA) in
pharmaceutical product development so long as such use does not disclose or incorporate the Company’s Confidential Information
into research and development of any products, including pharmaceutical products; (2) work in the field of oncology therapeutics,
excepting DNase-family enzymes as a component of oncology therapeutics, including combinations of DNase-family enzymes with
chemotherapy, cell therapies, or immunotherapies, and provided such work does not disclose or incorporate the Company’s
Confidential Information into research and development of any products, including therapeutic products; and (3) work in the general
area of cell therapies, including CAR T, so long as such work does not disclose or incorporate the Company’s Confidential
Information into research and development of any products, including therapeutic products.
E.Confidentiality
and Nondisclosure of this Agreement
1.
Executive acknowledges that the confidentiality and non-disclosure of all terms and conditions of this Agreement is an integral
part of the agreement to pay severance benefits to Executive, and was a material inducement for Company to enter into this Agreement.
2.
Executive agrees that Executive will maintain the terms of this Agreement in complete confidentiality. Executive shall make no
comments, to any person or entity, including but not limited to the media, friends, co-workers, or former co-workers from Company regarding
the Agreement, including the Separation Payment. For purposes of this Agreement, the word “comments” includes any form of
communication, whether oral, written, electronic or otherwise. Executive acknowledges that these nondisclosure provisions are an integral
part of this Agreement. Executive may disclose the terms of this Agreement to Executive’s spouse, attorneys and tax preparer/accountants
provided that such disclosure to the attorneys and tax preparer/accountants is made for the purposes of the attorneys and tax preparer/accountants
providing legal and/or tax advice and provided that Executive’s spouse, Executive’s attorneys and tax preparer/accountants
agree to be bound by this confidentiality section. Executive, if required by a Court order or subpoena, or as otherwise permitted by
law, may disclose the terms of this Agreement without breaching these confidentiality provisions provided that in the event a demand
is made upon Executive for the disclosure of the terms of the Agreement, Executive shall, within 48 hours immediately notify the Company
of the demand, so that Company may have sufficient time to seek any necessary orders, including a protective order, or to otherwise participate
in the tribunal’s determination of the issue.
F.
Waiver of Reemployment
Executive agrees that by executing
this Agreement, Executive waives and releases forever any right or rights Executive might have to seek or obtain employment, reemployment,
or reinstatement with Company or the Released Parties.
G.
Return of Company Property, Log Ins and Passwords
In order to be eligible to
receive the Separation Payment, immediately prior to the Effective Date, Executive must return to Company all Company property and all
Company confidential information in Executive’s possession, and Executive must provide to Company all log ins and passwords to any
software, website, application or program, which Executive maintained and used as part of the performance of Executive’s job duties
and responsibilities.
III.
Warranty of Capacity to Execute Agreement
Executive represents and warrants
that no other person or entity has or has had any interest in the claims, demands, obligations or causes of action referred to in this
Agreement; that Executive has the sole and exclusive right to receive sums specified in it; that Executive has not sold, assigned, transferred,
conveyed or otherwise disposed of any of the claims, demands, obligations or causes of action referred to in this Agreement; and that
Executive has the mental capacity to understand and execute the terms and conditions of the Agreement.
IV.
Disclaimer of Liability
Executive agrees to indemnify
and hold harmless Company and the Released Parties from any and all claims or liens presently existing against the Separation Payment
hereby by any person, entity or corporation, as well as any attorneys’ fees and costs incurred in representation of Company or the
Released Parties in litigation concerning any claims or liens, including but not limited to any claims or liens for attorneys’ fees
and costs.
V.
Entire Agreement & Successors in Interest
Except as otherwise provided
herein, Executive agrees that this Agreement contains the entire agreement between Executive and Company with respect to the matters
set forth in it, and shall be binding upon and inure to the benefit of Executive’s executors, administrators, personal representatives,
heirs, successors and assigns. There are no other understandings or agreements, verbal or otherwise, in relation thereto between the
Parties, except as herein expressly set forth. There have been no representations not set forth herein that Executive has relied upon
when entering into this Agreement. Executive agrees that should any provision of this Agreement require interpretation or construction
that all Parties have participated in the drafting of this document and no presumption regarding construing the document against one
Party shall apply.
VI.
Severability
If any provision in this Agreement
is found to be unenforceable, all other provisions will remain fully enforceable. The covenants set forth in this Agreement shall be considered
and construed as separate and independent covenants. Should any part or provision of any provision of this Agreement be held invalid,
void or unenforceable in any court of competent jurisdiction, such invalidity, voidness or unenforceability shall not render invalid,
void or unenforceable any other part or provision of this Agreement.
VII.
Governing Law
This Agreement is entered
into in the Commonwealth of Massachusetts, and shall be construed and interpreted in accordance with its laws. The Parties agree that
the proper and appropriate venue for any action arising from this Agreement shall be any court of competent jurisdiction in the Commonwealth
of Massachusetts or of the United States of America for the District of Massachusetts.
VIII.
Additional Documents
Executive agrees to cooperate
fully, and execute any and all supplementary documents, and take all additional actions which may be necessary or appropriate to give
full force and effect to the basic terms and intent of this Agreement.
IX.
Acknowledgement of Voluntariness and Opportunity for Review and Revocation
1.Executive
acknowledges that (a) Executive knowingly and voluntarily enters into this Agreement with the purpose of waiving any right and releasing
any claims under the Age Discrimination in Employment Act of 1967, 29 U.S.C. § 621, et seq. (“ADEA”); (b)
Executive was given a period of up to twenty-one (21) days within which to review and consider this Agreement; (c) Executive understood
Executive could use as much of said 21-day period as Executive desired; (d) Executive was encouraged by Company to consult with a lawyer,
at Executive’s own expense; (e) if Executive decided not to use the 21-day period, Executive is signing this Agreement voluntarily
and of Executive’s own free will; and (f) this Agreement is not final and binding until the seven-day period of revocation, described
in the following sentences of this Section of the Agreement, has expired. Executive understands that Company would not have given Executive
the special payments or benefits Executive is getting in exchange for this Agreement but for Executive’s promises and representations
Executive is making by signing it.
2.Executive
acknowledges that Executive may revoke Executive’s waiver of the rights and release of any ADEA (age discrimination) claims covered
by this Agreement, by delivering written notice of Executive’s revocation of this Agreement to Jim Parslow at j.parslow@xeneticbio.com,
no later than the close of business on the seventh (7th) calendar day after the date on which Executive signed this Agreement (the “Revocation
Period”). The written notice of revocation must state: “I HEREBY REVOKE MY ACCEPTANCE OF THE CONFIDENTIAL SEPARATION
AGREEMENT AND GENERAL RELEASE.” If the Agreement is revoked in a timely manner, this Agreement shall not be effective, and Executive
shall not receive the Separation Payment as described in Section II.C. herein.
X.
Effectiveness and Electronic Signatures
This Agreement shall become
effective following execution by all the Parties (“Effective Date”). This Agreement may be executed via manual signature
or electronic signature. “Electronic signature” means (a) the signing party’s manual signature, converted by the signing
party to facsimile or industry-accepted digital form (such as a .pdf file) and received from the signing party’s customary email
address, customary facsimile number, or other mutually agreed-upon authenticated source; or (b) the signing party’s digital signature
executed using a mutually agreed-upon digital signature service provider, such as DocuSign or Adobe sign, and digital signature process.
Each Party to this Agreement (i) agrees that it will be bound by its own electronic signature, (ii) accepts the electronic signature of
each other Party to this Agreement, and (iii) agrees that such electronic signatures shall be the legal equivalent of manual signatures.
This Agreement may be so executed in counterparts, each of which will be considered an original and all such counterparts will be considered
and constitute one and the same agreement.
XI.
Disparaging Statements
Neither the Executive nor
the Company shall make any remarks or statements, either publicly or privately, orally or in writing, that are disparaging of the other
party. The Executive shall not make any remarks or statements, either publicly, orally or in writing that are disparaging of the Company’s
actual or prospective business and/or, in such capacities, current or former employees, officers, directors, trade partners, vendors,
suppliers, or customers of the Company, either individually or collectively. For the avoidance of doubt, this includes remarks or statements,
public or private, made via electronic mail, blogs, social media (such as, Facebook, Twitter or X, LinkedIn, Instagram or any other similar
platform). This provision is subject to each party’s legally protected rights to communicate with governmental bodies and agencies
and to engage in otherwise legally protected activity.
[remainder of page intentionally blank]
EMPLOYEE: |
|
|
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/s/ Curtis
Lockshin |
|
|
Curtis
Lockshin |
|
|
Date: June 19, 2024 |
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COMPANY: |
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Xenetic Biosciences, Inc. |
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|
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By: |
/s/ James Parslow |
|
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Name:
James Parslow |
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Title: Interim Chief Executive Officer and Chief Financial Officer |
Date: June 19, 2024 |
|
|
[Signature page to Separation and Release Agreement]
Exhibit A
Xenetic Biosciences, Inc.
Curtis Lockshin – Outstanding Equity as of
May 16, 2024
Date of
Grant |
Shares |
Exercise
Price |
Expiration Date |
Total
Vested |
Total
Unvested & Forfeited as of May 16, 2024 |
Vesting |
Exercisability
post termination |
12/31/2014 |
122 |
$ 550.80 |
12/31/2024 |
122 |
- |
Fully Vested |
90-days post termination |
|
|
|
|
|
|
|
|
9/6/2015 |
127 |
$ 550.80 |
9/6/2025 |
127 |
- |
Fully Vested |
10-years from grant date (9/6/25) |
|
|
|
|
|
|
|
|
1/1/2017 |
1,459 |
$ 516.00 |
1/1/2027 |
1,459 |
- |
Fully Vested |
90-days post termination |
|
|
|
|
|
|
|
|
12/4/2019 |
9,000 |
$ 13.10 |
12/4/2029 |
9,000 |
- |
Fully Vested |
90-days post termination |
|
|
|
|
|
|
|
|
3/18/2021 |
5,000 |
$ 26.00 |
3/18/2031 |
5,000 |
- |
1/3rd on March 18, 2022; 2/3rds over remaining 8 quarters commencing June 18, 2022 thru March 18, 2024 |
90-days post termination |
|
|
|
|
|
|
|
|
3/24/2022 |
5,000 |
$11.20 |
3/24/2032 |
3,333 |
1,667 |
1/3rd on March 24, 2023; 2/3rds over remaining 8 quarters commencing June 24, 2023 thru March 24, 2025 |
90-days post termination |
|
|
|
|
|
|
|
|
12/11/2023 |
10,000 |
$3.88 |
12/11/2033 |
- |
10,000 |
1/3rd on December 11, 2024; 2/3rds over remaining 8 quarters commencing March 11, 2025 thru Dec 11, 2026 |
90-days post termination |
Exhibit 10.3
AMENDMENT TO
EMPLOYMENT AGREEMENT
This Amendment (the “Amendment”)
to the Employment Agreement dated as of March 23, 2017 (the “Agreement”), between XENETIC BIOSCIENCES, INC., a Nevada
corporation (the “Company”), and JAMES F. PARSLOW (the “Executive”) is dated as of June 18, 2024
(the “Execution Date”), and effective as of May 16, 2024 (the “Amendment Effective Date”). Capitalized
terms used herein and not otherwise defined shall have the meaning set forth in the Agreement.
The Company and Executive
desire to enter into this Amendment to the Agreement and hereby agree to the following as of the Amendment Effective Date:
| 1. | Section 2(a) of the Agreement is hereby amended by adding the following immediately following the last
sentence: |
“Effective as of the Amendment Effective
Date, the Executive (i) shall serve as Interim Chief Executive Officer, on an interim basis, and shall continue to serve as the Chief
Financial Officer of the Company, with responsibilities, duties and authority customary for each of such positions, subject to direction
by the Company’s Board of Directors (“Board”), and (ii) shall report directly to the Board; provided,
however, that in the event that the Executive is not selected by the Board to be the Chief Executive Officer following the interim period,
the Executive shall continue to serve as Chief Financial Officer with responsibilities, duties and authority customary for such position,
subject to the direction by the Company’s Chief Executive Officer and shall report directly to the Chief Executive Officer.”
| 2. | Section 3(a) of the Agreement is hereby amended by replacing the Base Salary referenced therein with “$400,000”,
which change was effective as of the Amendment Effective Date. |
| 3. | A new Section 3(f) is hereby added to the Agreement as follows: |
“(f) Retention Bonus. Executive
will be eligible to receive a retention bonus (the “Retention Bonus”) totaling $100,000, less payroll deductions and
all required withholdings, if Executive remains employed with the Company on the ten month anniversary of the Amendment Effective Date,
or March 16, 2025 (the “Retention Bonus Date”); provided, that in the event the Company terminates Executive’s
employment Without Cause prior to the Retention Bonus Date, Executive shall be entitled to receive the Retention Bonus. If earned, the
Retention Bonus shall be paid in the next payroll period following the Retention Bonus Date in accordance with the customary payroll practices
of the Company in effect at such time.”
| 4. | A new Section 5(c) is hereby added to the Agreement as follows: |
“(c) Retention Option. The
Company shall grant to Executive on the Execution Date a stock option to purchase 20,000 shares of common stock of the Company (the “Retention
Option”) under the Amended and Restated Xenetic Biosciences, Inc. Equity Incentive Plan, as amended from time to time (the
“Plan”) at an exercise price equal to the fair market value of the Company’s common stock on the grant date
(i.e., the Execution Date). The Retention Option shall vest one-fourth on the grant date, one-fourth upon the first anniversary of the
Execution Date, one-fourth upon the second anniversary of the Execution Date and one-fourth upon the third anniversary of the Execution
Date, provided the Executive remains employed with the Company on the applicable vesting date. The Retention Option shall be evidenced
in writing by, and subject to the terms and conditions of, the Plan, and, except as otherwise set forth herein, the Company’s standard
form of stock option agreement, which agreement shall expire ten (10) years from the date of grant except as otherwise provided herein,
in the stock option agreement or the Plan. Executive agrees that he will not loan or pledge any securities of the Company owned by him
or which he may accrue in the future through Stock Options or other equity awards as collateral for any indebtedness.”
| 5. | The Executive acknowledges and agrees that the change in title described in Section 2(a) is on an interim
basis and further acknowledges and agrees that any further changes to Executive’s title in the event the Executive is not chosen
as the Company’s Chief Executive Officer after an interim period, and any related changes in duties and other actions of the Company,
does not and shall not constitute “Good Reason” as defined in the Agreement. |
| 6. | All other provisions of the Agreement not amended hereby shall remain in full force and effect. |
[Signature pages follow]
IN WITNESS WHEREOF, the parties hereto have executed
this Amendment under seal as of the date and year first above written.
|
XENETIC BIOSCIENCES, INC. |
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By: |
/s/ Adam Logal |
|
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Name: |
Adam Logal |
|
|
|
|
Title |
Chairman of the Board of Directors |
Accepted
and Agreed to: |
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|
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/s/ James
F. Parslow |
|
|
James
F. Parslow |
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[Amendment to Employment Agreement]
EXHIBIT 31.1
I, James Parslow, certify that:
1. |
I have reviewed this Quarterly Report on Form 10-Q of Xenetic Biosciences, 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. |
I am 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. |
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: August 13, 2024
By: /s/ JAMES PARSLOW
James Parslow
Interim Chief Executive Officer
(Principal Executive Officer)
EXHIBIT 31.2
I, James Parslow, certify that:
1. |
I have reviewed this Quarterly Report on Form 10-Q of Xenetic Biosciences, 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. |
I am 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. |
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: August 13, 2024
By: /s/ JAMES PARSLOW
James Parslow
Chief Financial Officer
(Principal Financial and Principal Accounting Officer)
EXHIBIT 32.1
CERTIFICATION
Pursuant to the requirement set forth in Rule
13a-14(b) of the Securities Exchange Act of 1934, as amended, (the “Exchange Act”) and Section 1350 of Chapter 63 of Title
18 of the United States Code (18 U.S.C. §1350), James Parslow, Interim Chief Executive Officer and Chief Financial Officer of the
Xenetic Biosciences, Inc. (the “Company”) hereby certifies that, to the best of his knowledge:
The Company’s Quarterly Report on Form 10-Q
for the period ended June 30, 2024, to which this Certification is attached as Exhibit 32.1 (the “Periodic Report”), fully
complies with the requirements of Section 13(a) or Section 15(d) of the Exchange Act; and
The information contained in the Periodic Report
fairly presents, in all material respects, the financial condition and results of operations of the Company.
Date: August 13, 2024
In Witness Whereof,
the undersigned have set their hands hereto as of the 13th day of August 2024.
/s/James Parslow |
James Parslow |
Interim Chief Executive Officer and Chief Financial Officer
(Principal Executive Officer and Principal Financial Officer) |
“This certification accompanies the Form 10-Q to which it relates,
is not deemed filed with the Securities and Exchange Commission and is not to be incorporated by reference into any filing of Xenetic
Biosciences, Inc. under the Securities Act of 1933, as amended, or the Securities Exchange Act of 1934, as amended (whether made before
or after the date of the Form 10-Q), irrespective of any general incorporation language contained in such filing.”
v3.24.2.u1
Cover - shares
|
6 Months Ended |
|
Jun. 30, 2024 |
Aug. 09, 2024 |
Cover [Abstract] |
|
|
Document Type |
10-Q
|
|
Amendment Flag |
false
|
|
Document Quarterly Report |
true
|
|
Document Transition Report |
false
|
|
Document Period End Date |
Jun. 30, 2024
|
|
Document Fiscal Period Focus |
Q2
|
|
Document Fiscal Year Focus |
2024
|
|
Current Fiscal Year End Date |
--12-31
|
|
Entity File Number |
001-37937
|
|
Entity Registrant Name |
XENETIC BIOSCIENCES,
INC.
|
|
Entity Central Index Key |
0001534525
|
|
Entity Tax Identification Number |
45-2952962
|
|
Entity Incorporation, State or Country Code |
NV
|
|
Entity Address, Address Line One |
945 Concord Street
|
|
Entity Address, City or Town |
Framingham
|
|
Entity Address, State or Province |
MA
|
|
Entity Address, Postal Zip Code |
01701
|
|
City Area Code |
781
|
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Local Phone Number |
778-7720
|
|
Title of 12(b) Security |
Common Stock, $0.001 par value per share
|
|
Trading Symbol |
XBIO
|
|
Security Exchange Name |
NASDAQ
|
|
Entity Current Reporting Status |
Yes
|
|
Entity Interactive Data Current |
Yes
|
|
Entity Filer Category |
Non-accelerated Filer
|
|
Entity Small Business |
true
|
|
Entity Emerging Growth Company |
false
|
|
Entity Shell Company |
false
|
|
Entity Common Stock, Shares Outstanding |
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v3.24.2.u1
CONDENSED CONSOLIDATED BALANCE SHEETS (Unaudited) - USD ($)
|
Jun. 30, 2024 |
Dec. 31, 2023 |
Current assets: |
|
|
Cash |
$ 7,298,597
|
$ 8,983,046
|
Prepaid expenses, receivables and other |
716,381
|
603,828
|
Total current assets |
8,014,978
|
9,586,874
|
Other assets |
1,018,352
|
1,018,352
|
Total assets |
9,033,330
|
10,605,226
|
Current liabilities: |
|
|
Accounts payable |
283,586
|
240,832
|
Accrued expenses and other current liabilities |
1,304,016
|
568,753
|
Total current liabilities |
1,587,602
|
809,585
|
Total liabilities |
1,587,602
|
809,585
|
Commitments and contingencies |
|
|
Stockholders' equity: |
|
|
Common stock, $0.001 par value; 10,000,000 shares authorized as of June 30, 2024 and December 31, 2023; 1,543,802 and 1,543,385 shares issued as of June 30, 2024 and December 31, 2023, respectively; 1,541,101 and 1,540,684 shares outstanding as of June 30, 2024 and December 31, 2023, respectively |
1,544
|
1,544
|
Additional paid in capital |
208,173,105
|
208,053,935
|
Accumulated deficit |
(195,703,279)
|
(193,234,196)
|
Accumulated other comprehensive income |
253,734
|
253,734
|
Treasury stock |
(5,281,180)
|
(5,281,180)
|
Total stockholders' equity |
7,445,728
|
9,795,641
|
Total liabilities and stockholders' equity |
9,033,330
|
10,605,226
|
Series B Preferred Stock [Member] |
|
|
Stockholders' equity: |
|
|
Preferred Stock, Value, Issued |
$ 1,804
|
$ 1,804
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v3.24.2.u1
CONDENSED CONSOLIDATED BALANCE SHEETS (Unaudited) (Parenthetical) - $ / shares
|
Jun. 30, 2024 |
Dec. 31, 2023 |
Preferred Stock, Shares Authorized |
10,000,000
|
10,000,000
|
Common Stock, Par or Stated Value Per Share |
$ 0.001
|
$ 0.001
|
Common Stock, Shares Authorized |
10,000,000
|
10,000,000
|
Common Stock, Shares, Issued |
1,543,802
|
1,543,385
|
Common Stock, Shares, Outstanding |
1,541,101
|
1,540,684
|
Series B Preferred Stock [Member] |
|
|
Preferred Stock, Par or Stated Value Per Share |
$ 0.001
|
$ 0.001
|
Preferred Stock, Shares Issued |
1,804,394
|
1,804,394
|
Preferred Stock, Shares Outstanding |
1,804,394
|
1,804,394
|
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v3.24.2.u1
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS (Unaudited) - USD ($)
|
3 Months Ended |
6 Months Ended |
Jun. 30, 2024 |
Jun. 30, 2023 |
Jun. 30, 2024 |
Jun. 30, 2023 |
Revenue: |
|
|
|
|
Royalty revenue |
$ 726,404
|
$ 651,005
|
$ 1,237,221
|
$ 1,256,849
|
Total revenue |
726,404
|
651,005
|
1,237,221
|
1,256,849
|
Operating costs and expenses: |
|
|
|
|
Research and development |
(933,771)
|
(903,243)
|
(1,878,092)
|
(1,498,519)
|
General and administrative |
(1,130,029)
|
(945,950)
|
(1,964,939)
|
(1,871,693)
|
Total operating costs and expenses |
(2,063,800)
|
(1,849,193)
|
(3,843,031)
|
(3,370,212)
|
Loss from operations |
(1,337,396)
|
(1,198,188)
|
(2,605,810)
|
(2,113,363)
|
Other income (expense): |
|
|
|
|
Other (expense) income |
(21)
|
21,122
|
31
|
25,642
|
Interest income, net |
63,447
|
126,103
|
136,696
|
180,204
|
Total other income |
63,426
|
147,225
|
136,727
|
205,846
|
Net loss |
$ (1,273,970)
|
$ (1,050,963)
|
$ (2,469,083)
|
$ (1,907,517)
|
X |
- DefinitionThe aggregate total of expenses of managing and administering the affairs of an entity, including affiliates of the reporting entity, which are not directly or indirectly associated with the manufacture, sale or creation of a product or product line.
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v3.24.2.u1
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS (Unaudited) (Parenthetical) - $ / shares
|
3 Months Ended |
6 Months Ended |
Jun. 30, 2024 |
Jun. 30, 2023 |
Jun. 30, 2024 |
Jun. 30, 2023 |
Income Statement [Abstract] |
|
|
|
|
Earnings Per Share, Basic |
$ (0.83)
|
$ (0.69)
|
$ (1.60)
|
$ (1.25)
|
Earnings Per Share, Diluted |
$ (0.83)
|
$ (0.69)
|
$ (1.60)
|
$ (1.25)
|
Weighted Average Number of Shares Outstanding, Basic |
1,540,799
|
1,524,717
|
1,540,741
|
1,520,710
|
Weighted Average Number of Shares Outstanding, Diluted |
1,540,799
|
1,524,717
|
1,540,741
|
1,520,710
|
X |
- DefinitionThe amount of net income (loss) for the period per each share of common stock or unit outstanding during the reporting period.
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v3.24.2.u1
CONDENSED CONSOLIDATED STATEMENTS OF CHANGES IN STOCKHOLDERS' EQUITY (Unaudited) - USD ($)
|
Preferred Stock [Member] |
Common Stock [Member] |
Additional Paid-in Capital [Member] |
Retained Earnings [Member] |
AOCI Attributable to Parent [Member] |
Treasury Stock, Common [Member] |
Total |
Beginning balance, value at Dec. 31, 2022 |
$ 2,774
|
$ 1,520
|
$ 207,769,904
|
$ (189,099,618)
|
$ 253,734
|
$ (5,281,180)
|
$ 13,647,134
|
Beginning balance, shares at Dec. 31, 2022 |
2,774,394
|
1,519,360
|
|
|
|
|
|
Share-based expense |
|
|
138,241
|
|
|
|
138,241
|
Net loss |
|
|
|
(1,907,517)
|
|
|
(1,907,517)
|
Issuance of common stock to adjust for reverse split rounding |
|
$ 16
|
(16)
|
|
|
|
|
Issuance of common stock to adjust for reverse split rounding, shares |
|
15,941
|
|
|
|
|
|
Ending balance, value at Jun. 30, 2023 |
$ 2,774
|
$ 1,536
|
207,908,129
|
(191,007,135)
|
253,734
|
(5,281,180)
|
11,877,858
|
Ending balance, shares at Jun. 30, 2023 |
2,774,394
|
1,535,301
|
|
|
|
|
|
Beginning balance, value at Mar. 31, 2023 |
$ 2,774
|
$ 1,520
|
207,838,756
|
(189,956,172)
|
253,734
|
(5,281,180)
|
12,859,432
|
Beginning balance, shares at Mar. 31, 2023 |
2,774,394
|
1,519,360
|
|
|
|
|
|
Share-based expense |
|
|
69,389
|
|
|
|
69,389
|
Net loss |
|
|
|
(1,050,963)
|
|
|
(1,050,963)
|
Issuance of common stock to adjust for reverse split rounding |
|
$ 16
|
(16)
|
|
|
|
|
Issuance of common stock to adjust for reverse split rounding, shares |
|
15,941
|
|
|
|
|
|
Ending balance, value at Jun. 30, 2023 |
$ 2,774
|
$ 1,536
|
207,908,129
|
(191,007,135)
|
253,734
|
(5,281,180)
|
11,877,858
|
Ending balance, shares at Jun. 30, 2023 |
2,774,394
|
1,535,301
|
|
|
|
|
|
Beginning balance, value at Dec. 31, 2023 |
$ 1,804
|
$ 1,544
|
208,053,935
|
(193,234,196)
|
253,734
|
(5,281,180)
|
9,795,641
|
Beginning balance, shares at Dec. 31, 2023 |
1,804,394
|
1,543,385
|
|
|
|
|
|
Issuance of common stock in connection with restricted stock |
|
|
|
|
|
|
|
Issuance of common stock in connection with restricted stock, shares |
|
417
|
|
|
|
|
|
Share-based expense |
|
|
119,170
|
|
|
|
119,170
|
Net loss |
|
|
|
(2,469,083)
|
|
|
(2,469,083)
|
Ending balance, value at Jun. 30, 2024 |
$ 1,804
|
$ 1,544
|
208,173,105
|
(195,703,279)
|
253,734
|
(5,281,180)
|
7,445,728
|
Ending balance, shares at Jun. 30, 2024 |
1,804,394
|
1,543,802
|
|
|
|
|
|
Beginning balance, value at Mar. 31, 2024 |
$ 1,804
|
$ 1,544
|
208,131,009
|
(194,429,309)
|
253,734
|
(5,281,180)
|
8,677,602
|
Beginning balance, shares at Mar. 31, 2024 |
1,804,394
|
1,543,385
|
|
|
|
|
|
Issuance of common stock in connection with restricted stock |
|
|
|
|
|
|
|
Issuance of common stock in connection with restricted stock, shares |
|
417
|
|
|
|
|
|
Share-based expense |
|
|
42,096
|
|
|
|
42,096
|
Net loss |
|
|
|
(1,273,970)
|
|
|
(1,273,970)
|
Ending balance, value at Jun. 30, 2024 |
$ 1,804
|
$ 1,544
|
$ 208,173,105
|
$ (195,703,279)
|
$ 253,734
|
$ (5,281,180)
|
$ 7,445,728
|
Ending balance, shares at Jun. 30, 2024 |
1,804,394
|
1,543,802
|
|
|
|
|
|
X |
- References
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v3.24.2.u1
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS (Unaudited) - USD ($)
|
3 Months Ended |
6 Months Ended |
Jun. 30, 2024 |
Jun. 30, 2023 |
Jun. 30, 2024 |
Jun. 30, 2023 |
CASH FLOWS FROM OPERATING ACTIVITIES: |
|
|
|
|
Net loss |
$ (1,273,970)
|
$ (1,050,963)
|
$ (2,469,083)
|
$ (1,907,517)
|
Adjustments to reconcile net loss to net cash used in operating activities: |
|
|
|
|
Share-based expense |
42,096
|
69,389
|
119,170
|
138,241
|
Changes in operating assets and liabilities: |
|
|
|
|
Prepaid expenses, receivables and other |
|
|
(112,553)
|
(762,941)
|
Other assets |
|
|
0
|
362,500
|
Accounts payable, accrued expenses and other liabilities |
|
|
778,017
|
(201,841)
|
Net cash used in operating activities |
|
|
(1,684,449)
|
(2,371,558)
|
Net change in cash |
|
|
(1,684,449)
|
(2,371,558)
|
Cash at beginning of period |
|
|
8,983,046
|
13,097,265
|
Cash at end of period |
$ 7,298,597
|
$ 10,725,707
|
7,298,597
|
10,725,707
|
SUPPLEMENTAL CASH FLOW INFORMATION: |
|
|
|
|
Cash paid for interest |
|
|
$ 0
|
$ 0
|
X |
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v3.24.2.u1
Pay vs Performance Disclosure - USD ($)
|
3 Months Ended |
6 Months Ended |
Jun. 30, 2024 |
Jun. 30, 2023 |
Jun. 30, 2024 |
Jun. 30, 2023 |
Pay vs Performance Disclosure [Table] |
|
|
|
|
Net Income (Loss) |
$ (1,273,970)
|
$ (1,050,963)
|
$ (2,469,083)
|
$ (1,907,517)
|
X |
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v3.24.2.u1
The Company
|
6 Months Ended |
Jun. 30, 2024 |
Organization, Consolidation and Presentation of Financial Statements [Abstract] |
|
The Company |
Background
Xenetic Biosciences, Inc. (“Xenetic”
or the “Company”), incorporated in the state of Nevada and based in Framingham, Massachusetts, is a biopharmaceutical company
focused on advancing innovative immune-oncology technologies addressing hard to treat cancers. The Company’s proprietary Deoxyribonuclease
(“DNase”) platform is designed to improve outcomes of existing treatments, including immunotherapies, by targeting neutrophil
extracellular traps (“NETs”), which have been implicated in cancer progression and resistance to cancer treatments. Xenetic
is currently focused on advancing its systemic DNase program into the clinic as an adjunctive therapy for pancreatic carcinoma and locally
advanced or metastatic solid tumors. Additionally, Xenetic has partnered with biotechnology and pharmaceutical companies to develop its
proprietary drug delivery platform, PolyXen®, and receives royalty payments under an exclusive license arrangement in the
field of blood coagulation disorders.
As used in this Quarterly Report on Form 10-Q
(“Quarterly Report”), unless otherwise indicated, all references herein to “Xenetic,” the “Company,”
“we” or “us” refer to Xenetic Biosciences, Inc. and its wholly-owned subsidiaries.
The Company, directly or indirectly, through its
wholly-owned subsidiaries, Hesperix S.A. (“Hesperix”) and Xenetic Biosciences (U.K.) Limited (“Xenetic UK”), and
the wholly-owned subsidiaries of Xenetic UK, Lipoxen Technologies Limited (“Lipoxen”), Xenetic Bioscience, Incorporated and
SymbioTec, GmbH (“SymbioTec”), own various United States (“U.S.”) federal trademark registrations and applications
along with unregistered trademarks and service marks, including but not limited to XCART™, OncoHist™, PolyXen, ErepoXen™,
and ImuXen™, which may be used throughout this Quarterly Report. All other company and product names may be trademarks of the respective
companies with which they are associated.
Going Concern and Management’s Plan
Management evaluates whether there are
conditions or events, considered in the aggregate, that raise substantial doubt about the Company’s ability to continue as a
going concern within one year after the date that the financial statements are issued. The Company has incurred substantial losses
since its inception and expects to continue to incur operating losses in the near-term. The Company believes that its existing
resources will be adequate to fund the Company’s operations for a period of at least twelve months from the date of the
issuance of these financial statements. However, the Company anticipates it will need additional capital in the long-term to pursue
its business initiatives. While the Company believes it has access to capital resources through possible public or private equity
offerings, debt financings, corporate collaborations, related party funding, or other means to continue as a going concern, the
terms, timing and extent of any future financing will depend upon several factors, including the achievement of progress in its
product development programs, its ability to identify and enter into licensing or other strategic arrangements, its continued
listing on the Nasdaq Stock Market (“Nasdaq”), and factors related to financial, economic, geo-political, industry and
market conditions, many of which are beyond its control. The capital markets for the biotech industry can be highly volatile, which
make the terms, timing and extent of any future financing uncertain.
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v3.24.2.u1
Risks and Uncertainties
|
6 Months Ended |
Jun. 30, 2024 |
Risks and Uncertainties [Abstract] |
|
Risks and Uncertainties |
2. |
Risks and Uncertainties |
Impact of Global
Conflicts on Operations
The short and long-term
implications of Russia’s invasion of Ukraine and conflict in the Middle East are difficult to predict at this time. The imposition
of current and future sanctions and counter sanctions may have an adverse effect on the economic markets generally and could impact our
business, financial condition, and results of operations.
|
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- DefinitionThe entire disclosure for any concentrations existing at the date of the financial statements that make an entity vulnerable to a reasonably possible, near-term, severe impact. This disclosure informs financial statement users about the general nature of the risk associated with the concentration, and may indicate the percentage of concentration risk as of the balance sheet date.
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v3.24.2.u1
Summary of Significant Accounting Policies
|
6 Months Ended |
Jun. 30, 2024 |
Accounting Policies [Abstract] |
|
Summary of Significant Accounting Policies |
3. |
Summary of Significant Accounting Policies |
Preparation of Interim Financial Statements
The accompanying condensed consolidated interim
financial statements were prepared by the Company pursuant to the rules and regulations of the Securities and Exchange Commission (“SEC”)
and, in the opinion of management, include all normal and recurring adjustments necessary to present fairly the results of the interim
periods shown. Certain information and footnote disclosures normally included in financial statements prepared in accordance with U.S.
generally accepted accounting principles have been condensed or omitted pursuant to such SEC rules and regulations. Management believes
that the disclosures made are adequate to make the information presented not misleading. The results for the interim periods are not necessarily
indicative of results for the full year. The condensed consolidated financial statements contained herein should be read in conjunction
with the consolidated financial statements and notes thereto included in the Company’s Annual Report on Form 10-K for the year ended
December 31, 2023 filed with the SEC on March 21, 2024, and amended on April 26, 2024.
On May 15, 2023, the Company effected a reduction,
on a 1-for-10 basis, in its authorized common stock, par value $0.001, along with a corresponding and proportional decrease in the number
of shares issued and outstanding (the “Reverse Stock Split”). On the effective date of the Reverse Stock Split, (i) every
10 shares of common stock were reduced to one share of common stock, with any fractional amounts rounded up to one share; (ii) the number
of shares of common stock into which each outstanding warrant, restricted stock unit (“RSU”), or option to purchase common
stock was convertible into was proportionately reduced on the same basis as the common stock; (iii) the exercise price of each outstanding
warrant or option to purchase common stock was proportionately increased on a 1-to-10 basis; and (iv) the number of shares of common stock
into which each share of preferred stock was convertible into was proportionately reduced on the same basis as the common stock. Unless
otherwise indicated, all of the share numbers, share prices, and exercise prices have been adjusted in this Quarterly Report, on a retroactive
basis, to reflect this 1-for-10 Reverse Stock Split.
Principles of Consolidation
The condensed consolidated financial statements
of the Company include the accounts of Hesperix, Xenetic UK and Xenetic UK’s wholly owned subsidiaries: Lipoxen, Xenetic Bioscience,
Incorporated, and SymbioTec. Certain of the Company’s subsidiaries require guarantees of support from Xenetic. While all intercompany
balances and transactions have been eliminated in consolidation, the Company has $0.2 million of cash collateralizing these guarantees.
Basic and Diluted Net Loss per Share
The Company computes basic net loss per share
by dividing net loss applicable to common stockholders by the weighted-average number of shares of the Company’s common stock outstanding
during the period. The Company computes diluted net loss per share after giving consideration to the dilutive effect of stock options
that are outstanding during the period, except where such non-participating securities would be anti-dilutive.
For the three and six months ended June 30, 2024
and 2023, basic and diluted net loss per share are the same in each respective period due to the Company’s net loss position. Potentially
dilutive, non-participating securities have not been included in the calculations of diluted net loss per share, as their inclusion would
be anti-dilutive.
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v3.24.2.u1
Significant Strategic Collaborations
|
6 Months Ended |
Jun. 30, 2024 |
Organization, Consolidation and Presentation of Financial Statements [Abstract] |
|
Significant Strategic Collaborations |
4. |
Significant Strategic Collaborations |
Takeda Pharmaceutical Co. Ltd. (together
with its wholly-owned subsidiaries, “Takeda”)
In October 2017, the Company granted to Takeda
the right to grant a non-exclusive sublicense to certain patents related to the Company’s PolyXen technology that were previously
exclusively licensed to Takeda in connection with products related to the treatment of blood and bleeding disorders. Royalty payments
of approximately $0.7 million and $1.2 million were recorded as revenue by the Company during the three and six months ended June 30,
2024, respectively, and approximately $0.7 million and $1.3 million were recorded as revenue by the Company during the three and six months
ended June 30, 2023, respectively. These payments are based on single digit royalties on net sales of certain covered products. The Company’s
policy is to recognize royalty payments as revenue when they are reliably measurable, which is upon receipt of reports from Takeda. The
Company receives these reports in the quarter subsequent to the actual sublicensee sales. At the time the revenue was received, there
were no remaining performance obligations and all other revenue recognition criteria were met.
Belgian Volition SARL Limited (“Volition”)
Collaboration
On August 2, 2022, the Company announced a research
and development collaboration with Volition to develop NETs-targeted adoptive cell therapies for the treatment of cancer. The collaboration
is an early exploratory program to evaluate the potential combination of Volition’s Nu.Q® technology Test and the
Company’s DNase-Armored CAR T platform to develop proprietary adoptive cell therapies potentially targeting multiple types of solid
cancers. Under the terms of the collaboration agreement, Volition will fund a research program and the two parties will share proceeds
from commercialization or licensing of any products arising from the collaboration. To date, Volition has funded $26,000 under this agreement.
Catalent Pharma Solutions LLC (“Catalent”)
On June 30, 2022, the Company entered into a Statement
of Work (the “SOW”) with Catalent to outline the general scope of work, timeline, and pricing pursuant to which Catalent will
provide certain services to the Company to perform cGMP manufacturing of the Company’s recombinant protein, Human DNase I. The parties
agreed to enter into a Master Services Agreement that will contain terms and conditions to govern the project contemplated by the SOW
and that will supersede the addendum to the SOW containing Catalent's standard terms and conditions. The Company has paid Catalent approximately
$2.5 million through June 30, 2024, of which approximately $28,000 and $0.1 million has been recognized as an advance payment and is included
in prepaid expenses, receivables and other current assets as of June 30, 2024 and December 31, 2023, respectively, and approximately $49,000
has been recognized as a liability and is included in accrued expenses and other current liabilities as of June 30, 2024. There was no
accrual as of December 31, 2023. In addition, approximately $0.3 million has been recognized within other assets as of both June 30, 2024
and December 31, 2023.
Scripps Research Institute (“Scripps
Research”)
On March 17, 2023, the Company and Scripps Research
entered into a Research Funding and Option Agreement (the “Agreement”), pursuant to which the Company has agreed to provide
Scripps Research an aggregate of up to $0.9 million to fund research relating to advancing the pre-clinical development of the Company’s
DNase oncology platform technology. Under the Agreement, the Company has the option to acquire a worldwide exclusive license to Scripps
Research’s rights in the Technology or Patent Rights (as defined in the Agreement), as well as a non-exclusive, royalty-free, non-transferrable
license to make and use TSRI Technology (as defined in the Agreement) solely for the Company’s internal research purposes during
the performance of the research program contemplated by the Agreement. During the second quarter of 2024, the Company amended the
Agreement to extend the term to October 31, 2024 with no additional funding required. The Company has paid Scripps Research approximately
$0.9 million under the Agreement through June 30, 2024, of which approximately $0.1 million and $0.4 million has been recognized as an
advance payment and is included in prepaid expenses, receivables and other current assets as of June 30, 2024 and December 31, 2023, respectively.
University of Virginia (“UVA”)
On December 21, 2023, the Company entered into
a Research Funding and Material Transfer Agreement with UVA (the “UVA Agreement”) to advance the development of our systemic
DNase program. Under the terms of the UVA Agreement, in
addition to advancing our existing intellectual property, we have an option to acquire an exclusive license to any new intellectual property
arising from the DNase research program. Allan Tsung, MD, a member of the Company’s Scientific Advisory Board and Chair of
the Department of Surgery at the UVA School of Medicine, will oversee the research conducted under
the UVA Agreement. The Company has paid UVA approximately $0.2 million under the UVA Agreement through June 30, 2024, which was
expensed during the six months ended June 30, 2024. There were no amounts incurred as of December 31, 2023.
Other Agreements
The Company has also entered into various research,
development, license and supply agreements with Serum Institute of India (“Serum Institute”), PJSC Pharmsynthez (“Pharmsynthez”)
and SynBio LLC (“SynBio”), a wholly owned subsidiary of Pharmsynthez. The Company and its collaborative partners continue
to engage in research and development activities with no resultant commercial products through June 30, 2024. No amounts were recognized
as revenue related to the Serum Institute, Pharmsynthez or SynBio agreements during the three and six months ended June 30, 2024 and 2023,
respectively.
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v3.24.2.u1
Accrued Expenses and Other Current Liabilities
|
6 Months Ended |
Jun. 30, 2024 |
Payables and Accruals [Abstract] |
|
Accrued Expenses and Other Current Liabilities |
5. |
Accrued Expenses and Other Current Liabilities |
On June 19, 2024, the Company entered into a confidential
separation agreement and general release with each of Jeffrey F. Eisenberg, the Company’s former Chief Executive Officer (the “Eisenberg
Separation Agreement”), and Curtis Lockshin, the Company’s former Chief Scientific Officer (the “Lockshin Separation
Agreement” and together, the “Separation Agreements”) pursuant to which Messrs. Eisenberg and Lockshin were each eligible
for certain severance payments and benefits consistent with the terms of their existing employment agreements as described under “Employment
Agreements with our Named Executive Officers” in the Amendment No. 1 to Annual Report on Form 10-K/A filed by the Company with the
Securities and Exchange Commission on April 26, 2024. In addition, the Eisenberg Separation Agreement provides for accelerated vesting
of all of the unvested stock options held by Mr. Eisenberg as of May 16, 2024. As of June 30, 2024, the Company expensed approximately
$0.8 million of accrued payroll and benefits related to the Separation Agreements. In addition, the Company recorded approximately $13,000
of share-based expense for the accelerated vesting of unvested stock options. As of June 30, 2024, approximately $0.8 million was accrued
within accrued expenses and other current liabilities related to these obligations.
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- DefinitionThe entire disclosure for accounts payable and accrued liabilities at the end of the reporting period.
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v3.24.2.u1
Fair Value Measurements
|
6 Months Ended |
Jun. 30, 2024 |
Fair Value Disclosures [Abstract] |
|
Fair Value Measurements |
6. |
Fair Value Measurements |
Accounting Standards Codification Topic 820, Fair
Value Measurement, defines fair value as the price that would be received to sell an asset or be paid to transfer a liability in an
orderly transaction between market participants at the measurement date. The Company applies the following fair value hierarchy, which
prioritizes the inputs used to measure fair value into three levels and bases the categorization within the hierarchy upon the lowest
level of input that is available and significant to the fair value measurement. Level 1 inputs are unadjusted quoted prices in active
markets for identical assets or liabilities that the reporting entity has the ability to access at the measurement date. Level 2 utilizes
quoted market prices in markets that are not active, broker or dealer quotations, or alternative pricing sources with reasonable levels
of price transparency. Level 3 inputs are unobservable inputs for the asset or liability in which there is little, if any, market activity
for the asset or liability at the measurement date. As of June 30, 2024 and December 31, 2023, the carrying amounts of the Company’s
financial instruments approximates fair value due to their short maturities. There were no financial instruments classified as Level 3
in the fair value hierarchy during the three and six months ended June 30, 2024 and 2023.
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- DefinitionThe entire disclosure for the fair value of financial instruments (as defined), including financial assets and financial liabilities (collectively, as defined), and the measurements of those instruments as well as disclosures related to the fair value of non-financial assets and liabilities. Such disclosures about the financial instruments, assets, and liabilities would include: (1) the fair value of the required items together with their carrying amounts (as appropriate); (2) for items for which it is not practicable to estimate fair value, disclosure would include: (a) information pertinent to estimating fair value (including, carrying amount, effective interest rate, and maturity, and (b) the reasons why it is not practicable to estimate fair value; (3) significant concentrations of credit risk including: (a) information about the activity, region, or economic characteristics identifying a concentration, (b) the maximum amount of loss the entity is exposed to based on the gross fair value of the related item, (c) policy for requiring collateral or other security and information as to accessing such collateral or security, and (d) the nature and brief description of such collateral or security; (4) quantitative information about market risks and how such risks are managed; (5) for items measured on both a recurring and nonrecurring basis information regarding the inputs used to develop the fair value measurement; and (6) for items presented in the financial statement for which fair value measurement is elected: (a) information necessary to understand the reasons for the election, (b) discussion of the effect of fair value changes on earnings, (c) a description of [similar groups] items for which the election is made and the relation thereof to the balance sheet, the aggregate carrying value of items included in the balance sheet that are not eligible for the election; (7) all other required (as defined) and desired information.
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v3.24.2.u1
Stockholders’ Equity
|
6 Months Ended |
Jun. 30, 2024 |
Equity [Abstract] |
|
Stockholders’ Equity |
Common Stock
Each share of the Company’s
common stock entitles the holder to one vote on all matters submitted to a vote of the Company’s stockholders. Common stockholders
are entitled to dividends when and if declared by the Board of Directors. In the event of any voluntary or involuntary liquidation, dissolution
or winding-up of the Company, the holders of common stock are entitled to share ratably in the assets of the Company available for distribution.
On May 11, 2023, the Company filed a Certificate
of Change to the Company’s Articles of Incorporation with the Secretary of State of Nevada to effect the Reverse Stock Split. The
Reverse Stock Split was effective at 12:01 a.m., Eastern Time, on May 15, 2023. No fractional shares were issued as a result of the Reverse
Stock Split and any remaining share fractions were rounded up to the nearest whole share, resulting in 15,941 new shares of common stock
being issued to existing holders of the Company’s common stock.
Warrants
The Company
has warrants to purchase approximately 462,963 shares of the Company’s common stock (the “Series A Warrants”) outstanding
as of both June 30, 2024 and December 31, 2023. The Series A Warrants are immediately exercisable at a price of $33.00 per share of common
stock and expire on February 23, 2025. No Series A Warrants were exercised or forfeited during the three and six months ended June 30,
2024 and 2023.
In addition, the Company had publicly traded
warrants to purchase approximately 2,100
shares of common stock outstanding as of both June 30, 2024 and December 31, 2023. These warrants had an exercise price of $130.00
per share of common stock and expired on July
19, 2024. The warrants ceased trading on Nasdaq under the symbol “XBIOW” upon expiration. The warrants also provided that
if the weighted-average price of common stock on any trading day on or after 30 days after issuance is lower than the
then-applicable exercise price per share, each warrant may be exercised, at the option of the holder, on a cashless basis for one
share of common stock. None
of these warrants were exercised or forfeited during the three and six months ended June 30, 2024 and 2023.
The Company also has warrants to purchase approximately 800 shares
of the Company’s common stock outstanding as of both June 30, 2024 and December 31,
2023. These warrants have an exercise price of $29.09 per share of common stock and expire on July 3, 2026. None of these warrants were
exercised or forfeited during the three and six months ended June 30, 2024 and 2023.
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- DefinitionThe entire disclosure for equity.
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v3.24.2.u1
Share-Based Expense
|
6 Months Ended |
Jun. 30, 2024 |
Share-Based Payment Arrangement [Abstract] |
|
Share-Based Expense |
Total share-based expense related to stock options
and RSU’s was approximately $42,000 and $0.1 million for the three months ended June 30, 2024 and 2023, respectively, and approximately
$0.1 million and $0.1 million for each of the six months ended June 30, 2024 and 2023.
Share-based expense is classified in the condensed consolidated statements
of operations as follows:
Schedule of share-based compensation expense | |
| | | |
| | | |
| | | |
| | |
| |
Three Months Ended June 30, | | |
Six Months Ended June 30, | |
| |
2024 | | |
2023 | | |
2024 | | |
2023 | |
Research and development expenses | |
$ | (3,804 | ) | |
$ | 13,778 | | |
$ | 11,433 | | |
$ | 27,466 | |
General and administrative expenses | |
| 45,900 | | |
| 55,611 | | |
| 107,737 | | |
| 110,775 | |
| |
$ | 42,096 | | |
$ | 69,389 | | |
$ | 119,170 | | |
$ | 138,241 | |
Employee Stock Options and RSU’s
During the three and six months ended June 30,
2024, 20,000 stock options to purchase shares of common stock were granted by the Company. No stock option awards to purchase shares of
common stock were granted during the three and six months ended June 30, 2023. No RSUs were granted during each of the three and six months
ended June 30, 2024 and 2023. The Company recognized a total of approximately $42,000 and $0.1 million of share-based expense related
to employee stock options during the three months ended June 30, 2024 and 2023, respectively, and $0.1 million during each of the six
months ended June 30, 2024 and 2023, respectively. The Company issued 417 shares of common stock during the three and six months ended
June 30, 2024 related to RSU’s. No employee stock options were exercised during the three and six months ended June 30, 2024 and
2023. During the three and six months ended June 30, 2024 stock options to purchase 11,667 shares of common stock were forfeited. No employee
stock options expired during the three and six months ended June 30, 2023.
Non-Employee Stock Options
There were no non-employee stock options granted
or exercised during the three and six months ended June 30, 2024 and 2023, respectively. No non-employee stock option grants expired during
the three and six months ended June 30, 2024. During the six months ended June 30, 2023, non-employee stock option grants to purchase
approximately 100 shares of common stock expired. The Company did not recognize any expense related to non-employee stock options during
the three and six months ended June 30, 2024 and 2023, respectively.
|
X |
- DefinitionThe entire disclosure for share-based payment arrangement.
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v3.24.2.u1
Income Taxes
|
6 Months Ended |
Jun. 30, 2024 |
Income Tax Disclosure [Abstract] |
|
Income Taxes |
During the three and six months ended June 30,
2024 and 2023, there was no provision for income taxes as the Company incurred losses during both periods. Deferred tax assets and liabilities
reflect the net tax effect of temporary differences between the carrying amount of assets and liabilities for financial reporting purposes
and the amounts used for income tax purposes. The Company records a valuation allowance against its deferred tax assets as the Company
believes it is more likely than not the deferred tax assets will not be realized. The valuation allowance against deferred tax assets
was approximately $40.4 million and $39.7 million as of June 30, 2024 and December 31, 2023, respectively.
As of June 30, 2024 and December 31, 2023,
the Company did not record any unrecognized tax positions.
|
X |
- DefinitionThe entire disclosure for income tax.
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v3.24.2.u1
Related Party Transactions
|
6 Months Ended |
Jun. 30, 2024 |
Related Party Transactions [Abstract] |
|
Related Party Transactions |
10. |
Related Party Transactions |
The Company has entered into various research,
development, license and supply agreements with Serum Institute and Pharmsynthez, each a related party whose relationship has not materially
changed from that disclosed in the Company’s Annual Report on Form 10-K for the year ended December 31, 2023 filed with the SEC
on March 21, 2024, as amended on April 26, 2024.
During the fourth quarter
of 2019, the Company entered into a loan agreement with Pharmsynthez (the “Pharmsynthez Loan”), pursuant to which the Company
advanced Pharmsynthez an aggregate principal amount of up to $500,000 to be used for the development of a specific product under the Company’s
Co-Development Agreement with Pharmsynthez. The Pharmsynthez Loan had an initial term of 15-months and accrued interest at a rate of 10%
per annum. The Pharmsynthez Loan was guaranteed by all of the operating subsidiaries of Pharmsynthez, including SynBio and AS Kevelt,
and was secured by all of the common and preferred stock of the Company owned by Pharmsynthez and SynBio.
Pharmsynthez paid
all obligations due under the Pharmsynthez Loan in May 2023, and no further amounts are due under the Pharmsynthez Loan. As a
result, no amounts
were outstanding as of June 30, 2024 and December 31, 2023. The Company did not recognize any interest income related to the
Pharmsynthez Loan during the three and six months ended June 30, 2024. The Company recognized approximately $65,000 of
income related to interest and fees associated with the Pharmsynthez Loan including approximately $40,000 related
to interest income during the three and six months ended June 30, 2023.
|
X |
- DefinitionThe entire disclosure for related party transactions. Examples of related party transactions include transactions between (a) a parent company and its subsidiary; (b) subsidiaries of a common parent; (c) and entity and its principal owners; and (d) affiliates.
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v3.24.2.u1
Summary of Significant Accounting Policies (Policies)
|
6 Months Ended |
Jun. 30, 2024 |
Accounting Policies [Abstract] |
|
Preparation of Interim Financial Statements |
Preparation of Interim Financial Statements
The accompanying condensed consolidated interim
financial statements were prepared by the Company pursuant to the rules and regulations of the Securities and Exchange Commission (“SEC”)
and, in the opinion of management, include all normal and recurring adjustments necessary to present fairly the results of the interim
periods shown. Certain information and footnote disclosures normally included in financial statements prepared in accordance with U.S.
generally accepted accounting principles have been condensed or omitted pursuant to such SEC rules and regulations. Management believes
that the disclosures made are adequate to make the information presented not misleading. The results for the interim periods are not necessarily
indicative of results for the full year. The condensed consolidated financial statements contained herein should be read in conjunction
with the consolidated financial statements and notes thereto included in the Company’s Annual Report on Form 10-K for the year ended
December 31, 2023 filed with the SEC on March 21, 2024, and amended on April 26, 2024.
On May 15, 2023, the Company effected a reduction,
on a 1-for-10 basis, in its authorized common stock, par value $0.001, along with a corresponding and proportional decrease in the number
of shares issued and outstanding (the “Reverse Stock Split”). On the effective date of the Reverse Stock Split, (i) every
10 shares of common stock were reduced to one share of common stock, with any fractional amounts rounded up to one share; (ii) the number
of shares of common stock into which each outstanding warrant, restricted stock unit (“RSU”), or option to purchase common
stock was convertible into was proportionately reduced on the same basis as the common stock; (iii) the exercise price of each outstanding
warrant or option to purchase common stock was proportionately increased on a 1-to-10 basis; and (iv) the number of shares of common stock
into which each share of preferred stock was convertible into was proportionately reduced on the same basis as the common stock. Unless
otherwise indicated, all of the share numbers, share prices, and exercise prices have been adjusted in this Quarterly Report, on a retroactive
basis, to reflect this 1-for-10 Reverse Stock Split.
|
Principles of Consolidation |
Principles of Consolidation
The condensed consolidated financial statements
of the Company include the accounts of Hesperix, Xenetic UK and Xenetic UK’s wholly owned subsidiaries: Lipoxen, Xenetic Bioscience,
Incorporated, and SymbioTec. Certain of the Company’s subsidiaries require guarantees of support from Xenetic. While all intercompany
balances and transactions have been eliminated in consolidation, the Company has $0.2 million of cash collateralizing these guarantees.
|
Basic and Diluted Net Loss per Share |
Basic and Diluted Net Loss per Share
The Company computes basic net loss per share
by dividing net loss applicable to common stockholders by the weighted-average number of shares of the Company’s common stock outstanding
during the period. The Company computes diluted net loss per share after giving consideration to the dilutive effect of stock options
that are outstanding during the period, except where such non-participating securities would be anti-dilutive.
For the three and six months ended June 30, 2024
and 2023, basic and diluted net loss per share are the same in each respective period due to the Company’s net loss position. Potentially
dilutive, non-participating securities have not been included in the calculations of diluted net loss per share, as their inclusion would
be anti-dilutive.
|
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v3.24.2.u1
Share-Based Expense (Tables)
|
6 Months Ended |
Jun. 30, 2024 |
Share-Based Payment Arrangement [Abstract] |
|
Schedule of share-based compensation expense |
Schedule of share-based compensation expense | |
| | | |
| | | |
| | | |
| | |
| |
Three Months Ended June 30, | | |
Six Months Ended June 30, | |
| |
2024 | | |
2023 | | |
2024 | | |
2023 | |
Research and development expenses | |
$ | (3,804 | ) | |
$ | 13,778 | | |
$ | 11,433 | | |
$ | 27,466 | |
General and administrative expenses | |
| 45,900 | | |
| 55,611 | | |
| 107,737 | | |
| 110,775 | |
| |
$ | 42,096 | | |
$ | 69,389 | | |
$ | 119,170 | | |
$ | 138,241 | |
|
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v3.24.2.u1
Significant Strategic Collaborations (Details Narrative) - USD ($)
|
3 Months Ended |
6 Months Ended |
12 Months Ended |
16 Months Ended |
Jun. 30, 2024 |
Jun. 30, 2023 |
Jun. 30, 2024 |
Jun. 30, 2023 |
Dec. 31, 2023 |
Jun. 30, 2024 |
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] |
|
|
|
|
|
|
Royalty income |
$ 726,404
|
$ 651,005
|
$ 1,237,221
|
$ 1,256,849
|
|
|
Research and development expenses |
933,771
|
903,243
|
1,878,092
|
1,498,519
|
|
|
Prepaid expenses and other current assets |
716,381
|
|
716,381
|
|
$ 603,828
|
$ 716,381
|
Revenues |
726,404
|
651,005
|
1,237,221
|
1,256,849
|
|
|
Collaborative Agreements [Member] |
|
|
|
|
|
|
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] |
|
|
|
|
|
|
Revenues |
0
|
$ 0
|
0
|
$ 0
|
|
|
Catalent Pharma Solutions [Member] |
|
|
|
|
|
|
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] |
|
|
|
|
|
|
Research and development expenses |
|
|
2,500,000
|
|
|
|
Prepaid expenses and other current assets |
28,000
|
|
28,000
|
|
100,000
|
28,000
|
Accrued expenses and other current liabilities |
49,000
|
|
49,000
|
|
0
|
49,000
|
Other assets |
300,000
|
|
300,000
|
|
300,000
|
300,000
|
Scripps Research [Member] |
|
|
|
|
|
|
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] |
|
|
|
|
|
|
Research and development expenses |
|
|
|
|
|
900,000
|
Prepaid expenses and other current assets |
$ 100,000
|
|
100,000
|
|
400,000
|
$ 100,000
|
University Of Virginia [Member] |
|
|
|
|
|
|
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] |
|
|
|
|
|
|
Research and development expenses |
|
|
$ 200,000
|
|
$ 0
|
|
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|
3 Months Ended |
6 Months Ended |
Jun. 30, 2024 |
Jun. 30, 2023 |
Jun. 30, 2024 |
Jun. 30, 2023 |
Offsetting Assets [Line Items] |
|
|
|
|
Share based compensation |
$ 42,096
|
$ 69,389
|
$ 119,170
|
$ 138,241
|
Separation Agreements [Member] |
|
|
|
|
Offsetting Assets [Line Items] |
|
|
|
|
Labor and related expenses |
|
|
800,000
|
|
Share based compensation |
|
|
13,000
|
|
Accrued expenses and other current liabilities |
$ 800,000
|
|
$ 800,000
|
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|
|
3 Months Ended |
6 Months Ended |
|
May 11, 2023 |
Jun. 30, 2024 |
Jun. 30, 2023 |
Jun. 30, 2024 |
Jun. 30, 2023 |
Dec. 31, 2023 |
Publicly Traded Warrants [Member] |
|
|
|
|
|
|
Class of Stock [Line Items] |
|
|
|
|
|
|
Warrant Outstanding |
|
2,100
|
|
2,100
|
|
2,100
|
Exercise price |
|
$ 130.00
|
|
$ 130.00
|
|
|
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|
Jul. 19, 2024
|
|
Jul. 19, 2024
|
|
|
Other Warrants [Member] |
|
|
|
|
|
|
Class of Stock [Line Items] |
|
|
|
|
|
|
Warrant Outstanding |
|
800
|
|
800
|
|
800
|
Exercise price |
|
$ 29.09
|
|
$ 29.09
|
|
|
Maturity date |
|
Jul. 03, 2026
|
|
Jul. 03, 2026
|
|
|
Warrants exercised |
|
0
|
0
|
0
|
0
|
|
Warrants forfeited |
|
0
|
0
|
0
|
0
|
|
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|
|
|
|
|
|
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|
|
|
|
|
|
Issuance of common stock to adjust for reverse split rounding, shares |
15,941
|
|
|
|
|
|
Series A Warrants [Member] |
|
|
|
|
|
|
Class of Stock [Line Items] |
|
|
|
|
|
|
Warrant Outstanding |
|
462,963
|
|
462,963
|
|
462,963
|
Exercise price |
|
$ 33.00
|
|
$ 33.00
|
|
|
Maturity date |
|
Feb. 23, 2025
|
|
Feb. 23, 2025
|
|
|
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|
0
|
0
|
0
|
0
|
|
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|
0
|
0
|
0
|
0
|
|
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|
|
|
|
|
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|
|
|
|
|
|
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|
0
|
0
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0
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0
|
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|
0
|
0
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0
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0
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|
3 Months Ended |
6 Months Ended |
Jun. 30, 2024 |
Jun. 30, 2023 |
Jun. 30, 2024 |
Jun. 30, 2023 |
Share-Based Payment Arrangement, Expensed and Capitalized, Amount [Line Items] |
|
|
|
|
Share-based compensation |
$ 42,096
|
$ 69,389
|
$ 119,170
|
$ 138,241
|
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|
|
|
|
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|
|
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Share-based compensation |
(3,804)
|
13,778
|
11,433
|
27,466
|
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|
|
|
|
Share-Based Payment Arrangement, Expensed and Capitalized, Amount [Line Items] |
|
|
|
|
Share-based compensation |
$ 45,900
|
$ 55,611
|
$ 107,737
|
$ 110,775
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3 Months Ended |
6 Months Ended |
Jun. 30, 2024 |
Jun. 30, 2023 |
Jun. 30, 2024 |
Jun. 30, 2023 |
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] |
|
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|
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|
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|
|
|
|
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20,000
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|
$ 100,000
|
$ 100,000
|
$ 100,000
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|
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v3.24.2.u1
Income Taxes (Details Narrative) - USD ($)
|
3 Months Ended |
6 Months Ended |
|
Jun. 30, 2024 |
Jun. 30, 2023 |
Jun. 30, 2024 |
Jun. 30, 2023 |
Dec. 31, 2023 |
Income Tax Disclosure [Abstract] |
|
|
|
|
|
Provision for income taxes |
$ 0
|
$ 0
|
$ 0
|
$ 0
|
|
Deferred tax valuation allowance |
40,400,000
|
|
40,400,000
|
|
$ 39,700,000
|
Unrecognized tax positions |
$ 0
|
|
$ 0
|
|
$ 0
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