Panbela Therapeutics, Inc. (Nasdaq:
PBLA), a clinical stage company developing disruptive therapeutics
for the treatment of patients with urgent unmet medical needs,
today provides a business update and reports financial results for
the quarter ended June 30, 2023. As previously announced,
management is hosting an earnings call today at 4:30 p.m. ET.
Q2 2023 and Recent Highlights
Partnerships
- Divestiture of assets within eflornithine (DFMO) pediatric
neuroblastoma program to US WorldMeds® for an upfront payment of
$400,000 and contingent payments totaling up to an additional $9.1
million.
- Regained the North American rights to develop and commercialize
Flynpovi tm (the combination of CPP-1X (eflornithine) and
sulindac) in patients with familial adenomatous polyposis
(FAP).
Clinical
- Opened enrollment in the UK and Germany and has all planned
countries in the ASPIRE trial for pancreatic cancer now open and
actively enrolling.
- The independent Data Safety Monitoring Board (DSMB) of the
ASPIRE trial completed its pre-specified review of safety data for
treated patients in the trial. The DSMB has recommended that the
study continue without modification.
- PACES Phase III trial in colorectal cancer passed pre-planned
futility analysis.
- Entered into a clinical trial agreement with Moffitt Cancer
Center for a Phase I/II program in STK11 mutant non-small cell lung
cancer (NSCLC) in May.
- First patient enrolled in a JDRF funded Phase II double-blind,
randomized study to evaluate CPP-1X-T (eflornithine tablets) for
recent onset type 1 diabetes in April.
Financial/Business
- Closed a registered public offering for gross proceeds of $8.5
million in June 2023.
- Issued a new patent in Australia for claims of a novel process
for the production of SBP-101.
Communication of Science
- Poster presentation highlighting the results for CPP-1X in
recent onset type 1 diabetes at the Endocrine Society meeting in
June 2023.
- Entered into a sponsored research agreement with The University
of Texas MD Anderson Cancer Center for the evaluation of polyamine
metabolic inhibitor therapies in combination with CAR-T cell
therapies in preclinical models.
- Poster presentations of abstracts about CPP-1X (also known as
DFMO or eflornithine) research at the Immunology of Diabetes
Society (IDS) meeting in May 2023 and at the Endocrine Society
meeting in June 2023.
- Poster presentation highlighting the results for ivospemin
(SBP-101) as a polyamine metabolism modulator in ovarian cancer at
the American Association for Cancer Research (AACR), which took
place in April 2023.
- Entered into a new research agreement with the Johns Hopkins
University School of Medicine. The collaboration is intended to
expand the development of Panbela’s investigative agent ivospemin
(SBP-101).
“We continued to execute on our near-term operational priorities
in the second quarter, developing a deeper product pipeline for
patients with urgent unmet medical needs, that is mainly funded
through partnerships. After quarter end, we were also pleased to
monetize our neuroblastoma program with US World Meds for up to
$9.5 million in non-dilutive funding,” said Jennifer K. Simpson,
PhD, MSN, CRNP, President & Chief Executive Officer of Panbela.
“Additionally, we made important progress towards bringing new
potential treatments to patients suffering from pancreatic cancer,
colorectal cancer, STK11 mutant non-small cell lung cancer, ovarian
cancer and diabetes, while regaining the rights to commercialize
Flynpovi for FAP. Looking ahead, we expect to deliver value
creation for both patients and shareholders by advancing our robust
pipeline and executing against numerous upcoming milestones,
including interim data from the ASPIRE trial as soon as early
2024.”
Second Quarter ended June 30, 2023 Financial
Results
General and administrative expenses were $1.6 million in the
second quarter of 2023, compared to $1.3 million in the second
quarter of 2022. The change is primarily due to increased legal and
financial services costs.
Research and development expenses were $4.2 million in the
second quarter of 2023, compared to $20.0 million in the second
quarter of 2022. The second quarter of 2022 contained a one-time
write off of In Process Research and Development totaling $17.7
million. The remaining increase versus last year is due primarily
to costs associated with the ASPIRE clinical trial.
Net loss in the second quarter of 2023 was $5.8 million, or
$7.95 per diluted share, compared to a net loss of $22.1 million,
or $1,843.68 per diluted share, in the second quarter of 2022. All
share and per share amounts have been restated for a 30 for 1
reverse stock split that took effect on June 1, 2023.
Total cash was $7.2 million as of June 30, 2023. Total current
assets were $10.8 million and current liabilities were $10.6
million as of the same date. Notes payable, plus accrued interest,
on the balance sheet, the result of the acquisition of CPP, totaled
approximately $5.3 million. The current portion of the notes
payable plus accrued interest totaled approximately $1.1
million.
Conference Call Information
To participate in this event, dial approximately 5 to 10 minutes
before the beginning of the call.
Date: Thursday, August 10, 2023Time: 4:30 PM Eastern
TimeParticipant Numbers: Toll Free: 888-506-0062; Code:
681215International: 973-528-0011; Code: 681215Webcast:
https://www.webcaster4.com/Webcast/Page/2556/48679
Conference Call Replay Information
Toll Free: 877-481-4010International: 919-882-2331Replay
Passcode: 48679Webcast
replay: https://www.webcaster4.com/Webcast/Page/2556/48679
About our PipelineThe pipeline consists of
assets currently in clinical trials with an initial focus on
familial adenomatous polyposis (FAP), first-line metastatic
pancreatic cancer, neoadjuvant pancreatic cancer, colorectal cancer
prevention, ovarian cancer and diabetes. The combined development
programs have a steady cadence of catalysts with programs ranging
from pre-clinical to registration studies.
SBP-101 IvospeminIvospemin is a
proprietary polyamine analogue designed to induce polyamine
metabolic inhibition (PMI) by exploiting an observed high affinity
of the compound for pancreatic ductal adenocarcinoma and other
tumors. It has shown signals of tumor growth inhibition in clinical
studies of metastatic pancreatic cancer patients, demonstrating a
median overall survival (OS) of 14.6 months and an objective
response rate (ORR) of 48%, both exceeding what is typical for the
standard of care of gemcitabine + nab-paclitaxel suggesting
potential complementary activity with the existing FDA-approved
standard chemotherapy regimen. In data evaluated from clinical
studies to date, ivospemin has not shown exacerbation of bone
marrow suppression and peripheral neuropathy, which can be
chemotherapy-related adverse events. Serious visual adverse events
have been evaluated and patients with a history of retinopathy or
at risk of retinal detachment will be excluded from future SBP-101
studies. The safety data and PMI profile observed in the previous
Panbela-sponsored clinical trials provide support for continued
evaluation of ivospemin in the ASPIRE trial. For more information,
please
visit https://clinicaltrials.gov/ct2/show/NCT03412799.
Flynpovi ™Flynpovi is a combination of
CPP-1X (eflornithine) and sulindac with a dual mechanism inhibiting
polyamine synthesis and increase polyamine export and catabolism.
In a Phase 3 clinical trial in patients with sporadic large bowel
polyps, the combination prevented > 90% subsequent pre-cancerous
sporadic adenomas versus placebo. Focusing on FAP patients with
lower gastrointestinal tract anatomy in the recent Phase 3 trial
comparing Flynpovi to single agent eflornithine and single agent
sulindac, FAP patients with lower GI anatomy (patients with an
intact colon, retained rectum or surgical pouch), Flynpovi showed
statistically significant benefit compared to both single agents
(p≤0.02) in delaying surgical events in the lower GI for up to four
years. The safety profile for Flynpovi did not significantly differ
from the single agents and supports the continued evaluation of
Flynpovi for FAP.
CPP-1X EflornithineCPP-1X (eflornithine) is
being developed as a single agent tablet or high dose power sachet
for several indications including prevention of gastric cancer and
recent onset Type 1 diabetes. Preclinical studies as well as Phase
1 or Phase 2 investigator-initiated trials suggest that CPP-1X
treatment may be well-tolerated and has potential activity.
About PanbelaPanbela Therapeutics, Inc. is a
clinical-stage biopharmaceutical company developing disruptive
therapeutics for patients with urgent unmet medical needs.
Panbela’s lead assets are Ivospemin (SBP-101) and Flynpovi. Further
information can be found
at www.panbela.com. Panbela’s common
stock is listed on The Nasdaq Stock Market LLC under the symbol
“PBLA”.
Cautionary Statement Regarding Forward-Looking
StatementsThis press release contains
“forward-looking statements,” including within the meaning of the
Private Securities Litigation Reform Act of 1995. Forward-looking
statements can be identified by words such as: “anticipate,”
“design,” “may,” “plan,” and “will.” Examples of forward-looking
statements include statements we make regarding timing of
trials and results of collaborations with third parties and future
studies. All statements other than statements of historical fact
are statements that should be deemed forward-looking
statements. Forward-looking statements are neither historical
facts nor assurances of future performance. Instead, they are
based only on our current beliefs, expectations, and assumptions
regarding the future of our business, future plans and strategies,
projections, anticipated events and trends, the economy and other
future conditions. Because forward-looking statements relate
to the future, they are subject to inherent uncertainties, risks
and changes in circumstances that are difficult to predict and many
of which are outside of our control. Our actual results and
financial condition may differ materially and adversely from the
forward-looking statements. Therefore, you should not rely on
any of these forward-looking statements. Important factors
that could cause our actual results and financial condition to
differ materially from those indicated in the forward-looking
statements include, among others, the following: (i) our
ability to obtain additional funding to execute our business and
clinical development plans; (ii) our lack of diversification the
corresponding risk of an investment in our Company; (iii) our
ability to maintain our listing on a national securities exchange;
iv) progress and success of our clinical development program; (v)
our ability to demonstrate the safety and effectiveness of our
product candidates: ivospemin ( SBP-101 ),
Flynpovi, and eflornithine (CPP-1X) (v) our ability to
obtain regulatory approvals for our product candidates, SBP-101,
Flynpovi and CPP-1X in the United States, the European
Union or other international markets; (vii) the market acceptance
and level of future sales of our product candidates, SBP-101,
Flynpovi and CPP-1X ; (viii) the cost and delays in
product development that may result from changes in regulatory
oversight applicable to our product candidates, SBP-101, Flynpovi
and CPP-1X ; (ix) the rate of progress in establishing
reimbursement arrangements with third-party payors; (x) the effect
of competing technological and market developments; (xi) the costs
involved in filing and prosecuting patent applications and
enforcing or defending patent claims; ; and (xi) such other
factors as discussed in Part I, Item 1A under the caption “Risk
Factors” in our most recent Annual Report on Form 10-K, any
additional risks presented in our Quarterly Reports on Form 10-Q
and our Current Reports on Form 8-K. Any forward-looking statement
made by us in this press release is based on information currently
available to us and speaks only as of the date on which it is
made. We undertake no obligation to publicly update any
forward-looking statement or reasons why actual results would
differ from those anticipated in any such forward-looking
statement, whether written or oral, whether as a
result of new information, future developments or
otherwise.
Contact Information:Investors:James CarbonaraHayden IR(646)
755-7412james@haydenir.com
Media:Tammy GroenePanbela Therapeutics, Inc.(952)
479-1196IR@panbela.com
Panbela Therapeutics, Inc.Consolidated
Statements of Operations and Comprehensive Loss
(unaudited)(In thousands, except share and per share
amounts)
|
|
Three months ended June 30, |
|
Six months ended June 30, |
|
|
|
2023 |
|
|
|
2022 |
|
|
PercentChange |
|
|
2023 |
|
|
|
2022 |
|
|
PercentChange |
Operating expenses: |
|
|
|
|
|
|
|
|
|
|
|
|
General and administrative |
|
$ |
1,643 |
|
|
$ |
1,258 |
|
|
30.6 |
% |
|
$ |
2,995 |
|
|
$ |
3,053 |
|
|
-1.9 |
% |
Research and development |
|
|
4,234 |
|
|
|
20,028 |
|
|
-78.9 |
% |
|
|
7,750 |
|
|
|
22,236 |
|
|
-65.1 |
% |
Operating loss |
|
|
(5,877 |
) |
|
|
(21,286 |
) |
|
-72.4 |
% |
|
|
(10,745 |
) |
|
|
(25,289 |
) |
|
-57.5 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
Other income (expense): |
|
|
|
|
|
|
|
|
|
|
|
|
Interest income |
|
|
49 |
|
|
|
2 |
|
|
- |
|
|
|
65 |
|
|
|
2 |
|
|
3150.0 |
% |
Interest expense |
|
|
(70 |
) |
|
|
(16 |
) |
|
337.5 |
% |
|
|
(173 |
) |
|
|
(20 |
) |
|
765.0 |
% |
Other income (expense) |
|
|
(82 |
) |
|
|
(848 |
) |
|
-90.3 |
% |
|
|
(248 |
) |
|
|
(536 |
) |
|
-53.7 |
% |
Total other income (expense) |
|
|
(103 |
) |
|
|
(862 |
) |
|
-88.1 |
% |
|
|
(356 |
) |
|
|
(554 |
) |
|
-35.7 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
Loss before income tax benefit |
|
|
(5,980 |
) |
|
|
(22,148 |
) |
|
-73.0 |
% |
|
|
(11,101 |
) |
|
|
(25,843 |
) |
|
-57.0 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
Income tax benefit |
|
|
147 |
|
|
|
18 |
|
|
716.7 |
% |
|
|
149 |
|
|
|
47 |
|
|
217.0 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss |
|
|
(5,833 |
) |
|
|
(22,130 |
) |
|
-73.6 |
% |
|
|
(10,952 |
) |
|
|
(25,796 |
) |
|
-57.5 |
% |
Foreign currency translation adjustment |
|
|
67 |
|
|
|
813 |
|
|
-91.8 |
% |
|
|
231 |
|
|
|
514 |
|
|
-55.1 |
% |
Comprehensive Loss |
|
$ |
(5,766 |
) |
|
$ |
(21,317 |
) |
|
-73.0 |
% |
|
$ |
(10,721 |
) |
|
$ |
(25,282 |
) |
|
-57.6 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic and diluted net loss per share |
|
$ |
(7.95 |
) |
|
$ |
(1,843.68 |
) |
|
-99.6 |
% |
|
$ |
(22.08 |
) |
|
$ |
(2,243.10 |
) |
|
-99.0 |
% |
Weighted average shares outstanding - basic and diluted |
|
|
733,314 |
|
|
|
12,003 |
|
|
6009.4 |
% |
|
|
496,013 |
|
|
|
11,500 |
|
|
4213.2 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
Panbela Therapeutics, Inc.Consolidated
Balance Sheets (unaudited)(In thousands, except share
amounts)
|
|
June 30, 2023 |
|
December 31, 2022 |
ASSETS |
|
(Unaudited) |
|
|
Current assets: |
|
|
|
|
Cash and cash equivalents |
|
$ |
7,205 |
|
|
$ |
1,285 |
|
Prepaid expenses and other current assets |
|
|
3,411 |
|
|
|
443 |
|
Income tax receivable |
|
|
193 |
|
|
|
49 |
|
Total current assets |
|
|
10,809 |
|
|
|
1,777 |
|
Other non-current assets |
|
|
8,742 |
|
|
|
3,201 |
|
Total assets |
|
$ |
19,551 |
|
|
$ |
4,978 |
|
|
|
|
|
|
LIABILITIES AND STOCKHOLDERS' EQUITY
(DEFICIT) |
|
|
|
|
|
|
Current liabilities: |
|
|
|
|
Accounts payable |
|
$ |
8,440 |
|
|
$ |
2,865 |
|
Accrued expenses |
|
|
1,008 |
|
|
|
2,993 |
|
Accrued interest payable |
|
|
107 |
|
|
|
325 |
|
Note payable |
|
|
- |
|
|
|
650 |
|
Debt, current portion |
|
|
1,000 |
|
|
|
1,000 |
|
Total current liabilities |
|
|
10,555 |
|
|
|
7,833 |
|
|
|
|
|
|
Debt, net of current portion |
|
|
4,194 |
|
|
|
5,194 |
|
Total non-current liabilities |
|
|
4,194 |
|
|
|
5,194 |
|
|
|
|
|
|
Total liabilities |
|
|
14,749 |
|
|
|
13,027 |
|
|
|
|
|
|
Stockholders' equity (deficit): |
|
|
|
|
Preferred stock, $0.001 par value; 10,000,000 authorized; no shares
issued or outstanding as of June 30, 2023 and December 31,
2022 |
|
|
- |
|
|
|
- |
|
Common stock, $0.001 par value; 100,000,000 authorized; 2,612,038
and 34,761 shares issued and outstanding as of June 30, 2023 and
December 31, 2022, respectively |
|
|
3 |
|
|
|
- |
|
Additional paid-in capital |
|
|
105,855 |
|
|
|
82,286 |
|
Accumulated deficit |
|
|
(102,046 |
) |
|
|
(91,094 |
) |
Accumulated comprehensive income |
|
|
990 |
|
|
|
759 |
|
Total stockholders' equity (deficit) |
|
|
4,802 |
|
|
|
(8,049 |
) |
Total liabilities and stockholders' equity (deficit) |
|
$ |
19,551 |
|
|
$ |
4,978 |
|
|
|
|
|
|
Panbela Therapeutics, Inc.Consolidated
Statements of Cash Flows (unaudited)(In
thousands)
|
|
Six Months Ended June 30, |
|
|
|
2023 |
|
|
|
2022 |
|
Cash flows from operating activities: |
|
|
|
|
Net loss |
|
$ |
(10,952 |
) |
|
$ |
(25,796 |
) |
Adjustments to reconcile net loss to net cash used in operating
activities: |
|
|
|
|
|
|
Write off of in process research and development (IPR&D) |
|
|
- |
|
|
|
17,737 |
|
Stock-based compensation |
|
|
509 |
|
|
|
627 |
|
Non-cash interest expense |
|
|
107 |
|
|
|
13 |
|
Changes in operating assets and liabilities: |
|
|
|
|
Income tax receivable |
|
|
(149 |
) |
|
|
(33 |
) |
Prepaid expenses and other current assets |
|
|
(2,967 |
) |
|
|
(219 |
) |
Other non-current assets |
|
|
(5,541 |
) |
|
|
(2,561 |
) |
Accounts payable |
|
|
5,812 |
|
|
|
2,483 |
|
Accrued liabilities |
|
|
(2,311 |
) |
|
|
(931 |
) |
Net cash used in operating activities |
|
|
(15,492 |
) |
|
|
(8,680 |
) |
|
|
|
|
|
Cash flows from investing activities: |
|
|
|
|
Investment in IPR&D |
|
|
- |
|
|
|
(659 |
) |
Cash acquired in merger |
|
|
- |
|
|
|
4 |
|
Net cash used in investing activities |
|
|
- |
|
|
|
(655 |
) |
Cash flows from financing activities: |
|
|
|
|
Proceeds from sale of common stock and warrants, net of $2.1
million of offering costs |
|
|
23,071 |
|
|
|
- |
|
Cash paid for fractional shares |
|
|
(9 |
) |
|
|
- |
|
Principal payments on notes |
|
|
(1,650 |
) |
|
|
- |
|
Net cash provided by financing activities |
|
|
21,412 |
|
|
|
- |
|
|
|
|
|
|
Effect of exchange rate changes on cash |
|
|
- |
|
|
|
(2 |
) |
|
|
|
|
|
Net change in cash |
|
|
5,920 |
|
|
|
(9,337 |
) |
Cash and cash equivalents at beginning of period |
|
|
1,285 |
|
|
|
11,867 |
|
Cash and cash equivalents at end of period |
|
$ |
7,205 |
|
|
$ |
2,530 |
|
|
|
|
|
|
Supplemental disclosure of cash flow
information: |
|
|
|
|
Cash paid during period for interest |
|
$ |
386 |
|
|
$ |
7 |
|
|
|
|
|
|
Supplemental disclosure of non-cash
transactions: |
|
|
|
|
Fair value of common stock, stock options and stock warrants issued
as consideration for asset acquisition |
|
$ |
- |
|
|
$ |
9,605 |
|
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