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 and full year ended
December 31, 2023. As previously announced, management is hosting
earnings call today at 4:30 p.m. ET.
2023 and early 2024 Highlights:
Collaborations
- Divestiture of Assets within Eflornithine (DFMO) Pediatric
Neuroblastoma Program to US WorldMeds – Panbela to receive up to
$9.5 Million
- Entered into Sponsored Research Agreement with MD Anderson
Cancer Center to Evaluate Polyamine Metabolic Inhibitor Therapy in
Combination with CAR-T Cell Therapy and bispecific monoclonal
antibodies
- New Research Agreement with Johns Hopkins University School of
Medicine
Clinical
- Acceptance of Ivospemin (SBP-101) Abstract for Poster
Presentation at American Association for Cancer Research (AACR)
meeting April 5-10, 2024
- ASPIRE trial exceeded 50% enrollment; complete enrollment of
approximately 600 patients anticipated by Q1 2025
- Publication of Clinical Data: Phase 1 study of high-dose DFMO,
celecoxib, cyclophosphamide and topotecan for patients with
relapsed neuroblastoma: a New Approaches to Neuroblastoma Therapy
trial. Br J Cancer 130, 788–797 (2024)
- Opened – Phase I non-small cell lung cancer (NSCLC) Trial
- Opened – Phase II recent onset Type I Diabetes Trial
- Announced Futility Analysis Phase III Colon Cancer Risk
Reduction Trial (PACES) – trial continues without modification
- Adoption of Commission Implementing Decision from the EMA for
Orphan Designation of Ivospemin (SBP-101)
- Prespecified Safety Analysis by Data Safety Monitoring Board
(DSMB) for the ASPIRE Trial – continue without modification (two
meetings held: July and November)
- Publication of Phase I Type I early onset Diabetes Data:
Inhibition of Polyamine Biosynthesis Preserves β Cell Function in
Type 1 Diabetes. Cell Rep Med. 2023 Nov 21; 4(11):102161.
Doi:10.1016/j.xcrm.2023.101261.Epub 2023 Nov 1
Financial / Business
- In aggregate, closed $39.1 million gross proceeds from equity
during 2023 and Q1 2024
- Validation of European Patent for Claims of a Novel Process for
the Production of SBP-101 (ivospemin)
- Issuance of New Patent in China, Australia, and Japan for
Claims of a Novel Process for the Production of SBP-101
(ivospemin)
- Issuance of New Patent in Chile for Claims of a Novel Process
for the Production of Flynpovi
“For Panbela, 2023 and early 2024 has been characterized by
remarkable achievements across collaborations, clinical endeavors,
and financial milestones. Significantly, our Phase III ASPIRE trial
for untreated metastatic pancreatic ductal adenocarcinoma exceeded
50% enrollment and we anticipate full enrollment of approximately
600 patients to be completed by the first quarter of 2025. With the
recent approval of Onivyde in first line metastatic pancreatic
cancer, the first approval in this space in approximately 11 years,
we are encouraged and look forward to our interim analysis and the
potential for another option for metastatic pancreatic cancer
patients,” said Jennifer K. Simpson, PhD, MSN, CRNP, President
& CEO of Panbela. “Looking ahead, Panbela remains unwavering in
its commitment to patients and in its pursuit of maximizing value
for stockholders. We are progressing towards several catalysts,
including the overall survival interim analysis in our Phase III
ASPIRE Trial."
Fourth Quarter ended December 31, 2023 Financial
Results
General and administrative expenses were $0.9 million in the
fourth quarter of 2023, compared to $1.7 million in the fourth
quarter of 2022.
Research and development expenses were $6.1 million in the
fourth quarter of 2023, compared to $3.5 million in the fourth
quarter of 2022.
Net loss in the fourth quarter of 2023 was $6.5 million, or
$65.90 per diluted share, compared to a net loss of $4.7 million,
or $344.61 per diluted share, in the fourth quarter of 2022.
Total cash was $2.6 million as of December 31, 2023. Total
current assets were $3.1 million and current liabilities were $12.3
million as of the same date. Notes payable, plus accrued interest,
on the balance sheet, the result of the acquisition of CPP, totaled
approximately $5.4 million. The current portion of the notes
payable plus accrued interest totaled approximately $1.2 million
and was paid to the noteholder in the first quarter of 2024.
Subsequent to the end of the year, the Company completed a
registered public offering. Gross proceeds from the raise, which
closed on January 31, 2024, were approximately $9 million.
Conference Call Information
March 26, 2024 at 4:30PM EST
Toll Free: 888-506-0062International: 973-528-0011Participant
Access Code: 195310Webcast
Link: https://www.webcaster4.com/Webcast/Page/2556/49978
Conference Call Replay Information
Toll Free: 877-481-4010International: 919-882-2331Replay
Passcode: 49978Webcast
Replay: https://www.webcaster4.com/Webcast/Page/2556/49978
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/study/NCT03412799 .
Flynpovi™Flynpovi is a combination of CPP-1X
(eflornithine) and sulindac with a dual mechanism inhibiting
polyamine synthesis and increasing 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” and is currently trading on the OTCPink market under the
same ticker. Panbela is currently pursuing a new listing of its
common stock on a national securities exchange.
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 and
the corresponding risk of an investment in our Company; (iii) our
ability to obtain or maintain our listing on a national securities
exchange; (iv) the 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); (vi) 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 (xii) 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) 479-1196
Panbela Therapeutics, Inc.Consolidated
Statements of Operations and Comprehensive Loss
(unaudited)(In thousands, except share and per share
amounts)
|
Three months ended December 31, |
|
Year ended December 31, |
|
|
2023 |
|
|
|
2022 |
|
|
Percent Change |
|
|
2023 |
|
|
|
2022 |
|
|
Percent Change |
Operating expenses: |
|
|
|
|
|
|
|
|
|
|
|
General and administrative |
$ |
931 |
|
|
$ |
1,661 |
|
|
-43.9 |
% |
|
$ |
5,033 |
|
|
$ |
6,044 |
|
|
-16.7 |
% |
Research and development |
|
6,116 |
|
|
|
3,463 |
|
|
76.6 |
% |
|
|
20,614 |
|
|
|
28,049 |
|
|
-26.5 |
% |
Operating loss |
|
(7,047 |
) |
|
|
(5,124 |
) |
|
37.5 |
% |
|
|
(25,647 |
) |
|
|
(34,093 |
) |
|
-24.8 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
Other income (expense): |
|
|
|
|
|
|
|
|
|
|
|
Interest income |
|
9 |
|
|
|
3 |
|
|
200.0 |
% |
|
|
123 |
|
|
|
14 |
|
|
778.6 |
% |
Gain on sale of intellectual property |
|
- |
|
|
|
- |
|
|
- |
|
|
|
400 |
|
|
|
0 |
|
|
- |
|
Interest expense |
|
(71 |
) |
|
|
(181 |
) |
|
-60.8 |
% |
|
|
(317 |
) |
|
|
(288 |
) |
|
10.1 |
% |
Other income (expense) |
|
597 |
|
|
|
556 |
|
|
7.4 |
% |
|
|
(8 |
) |
|
|
(682 |
) |
|
-98.8 |
% |
Total other income (expense) |
|
535 |
|
|
|
378 |
|
|
41.5 |
% |
|
|
198 |
|
|
|
(956 |
) |
|
-120.7 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
Loss before income tax
benefit |
|
(6,512 |
) |
|
|
(4,746 |
) |
|
37.2 |
% |
|
|
(25,449 |
) |
|
|
(35,049 |
) |
|
-27.4 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
Income tax benefit |
|
19 |
|
|
|
13 |
|
|
46.2 |
% |
|
|
186 |
|
|
|
116 |
|
|
60.3 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
Net loss |
|
(6,493 |
) |
|
|
(4,733 |
) |
|
37.2 |
% |
|
|
(25,263 |
) |
|
|
(34,933 |
) |
|
-27.7 |
% |
Foreign currency translation
adjustment (loss) |
|
(626 |
) |
|
|
(615 |
) |
|
1.8 |
% |
|
|
(14 |
) |
|
|
626 |
|
|
-102.2 |
% |
Comprehensive Loss |
$ |
(7,119 |
) |
|
$ |
(5,348 |
) |
|
33.1 |
% |
|
$ |
(25,277 |
) |
|
$ |
(34,307 |
) |
|
-26.3 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
Basic and diluted net loss per
share |
$ |
(65.90 |
) |
|
$ |
(344.61 |
) |
|
-80.9 |
% |
|
$ |
(316.52 |
) |
|
$ |
(41,341.21 |
) |
|
-99.2 |
% |
Weighted average shares
outstanding - basic and diluted |
|
237,234 |
|
|
|
1,374 |
|
|
17165.9 |
% |
|
|
108,691 |
|
|
|
845 |
|
|
12762.8 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Panbela Therapeutics, Inc.Consolidated
Balance Sheets (unaudited)(In thousands, except share
amounts)
|
December 31, 2023 |
|
December 31, 2022 |
ASSETS |
|
|
|
Current assets: |
|
|
|
Cash and cash equivalents |
$ |
2,578 |
|
|
$ |
1,285 |
|
Prepaid expenses and other current assets |
|
299 |
|
|
|
443 |
|
Income tax receivable |
|
183 |
|
|
|
49 |
|
Total current assets |
|
3,060 |
|
|
|
1,777 |
|
Other noncurrent assets |
|
8,742 |
|
|
|
3,201 |
|
Total assets |
$ |
11,802 |
|
|
$ |
4,978 |
|
|
|
|
|
LIABILITIES AND STOCKHOLDERS' DEFICIT |
|
|
|
Current liabilities: |
|
|
|
Accounts payable |
$ |
9,939 |
|
|
$ |
2,865 |
|
Accrued expenses |
|
1,141 |
|
|
|
2,993 |
|
Accrued interest payable |
|
238 |
|
|
|
325 |
|
Note payable |
|
- |
|
|
|
650 |
|
Debt, current portion |
|
1,000 |
|
|
|
1,000 |
|
Total current liabilities |
|
12,318 |
|
|
|
7,833 |
|
|
|
|
|
Debt, net of current portion |
|
4,194 |
|
|
|
5,194 |
|
Total non current
liabilities |
|
4,194 |
|
|
|
5,194 |
|
|
|
|
|
Total liabilities |
|
16,512 |
|
|
|
13,027 |
|
|
|
|
|
Stockholders' deficit: |
|
|
|
Preferred stock, $0.001 par value; 10,000,000 authorized; no shares
issued or outstanding as of December 31, 2023 and December 31,
2022 |
|
- |
|
|
|
- |
|
Common stock, $0.001 par value; 100,000,000 authorized; 480,095 and
1,738 shares issued, and 480,025 and 1,738 shares outstanding, as
of December 31, 2023 and December 31, 2022, respectively |
|
- |
|
|
|
- |
|
Treasury Stock at cost; 70 and 0 shares as of December 31, 2023 and
December 31, 2022, respectively |
|
(1 |
) |
|
|
- |
|
Additional paid-in capital |
|
120,043 |
|
|
|
82,286 |
|
Accumulated deficit |
|
(125,497 |
) |
|
|
(91,094 |
) |
Accumulated comprehensive income |
|
745 |
|
|
|
759 |
|
Total stockholders'
deficit |
|
(4,710 |
) |
|
|
(8,049 |
) |
Total liabilities and
stockholders' deficit |
$ |
11,802 |
|
|
$ |
4,978 |
|
|
|
|
|
|
|
|
|
Panbela Therapeutics, Inc.Consolidated
Statements of Cash Flows (unaudited)(In thousands)
|
Year Ended December 31, |
|
|
2023 |
|
|
|
2022 |
|
Cash flows from
operating activities: |
|
|
|
Net loss |
$ |
(25,263 |
) |
|
$ |
(34,933 |
) |
Adjustments to reconcile net loss to net cash used in operating
activities: |
|
|
|
Write off of in process research and development (IPR&D) |
|
- |
|
|
|
17,737 |
|
Gain on sale of intellectual property |
|
(400 |
) |
|
|
- |
|
Stock-based compensation |
|
823 |
|
|
|
1,088 |
|
Non-cash interest expense |
|
238 |
|
|
|
273 |
|
Changes in operating assets and liabilities: |
|
|
|
Income tax receivable |
|
(132 |
) |
|
|
212 |
|
Prepaid expenses and other current assets |
|
145 |
|
|
|
(127 |
) |
Deposits held for clinical trial costs |
|
(5,541 |
) |
|
|
(2,561 |
) |
Accounts payable |
|
7,060 |
|
|
|
2,249 |
|
Accrued liabilities |
|
(2,179 |
) |
|
|
786 |
|
Net cash used in operating activities |
|
(25,249 |
) |
|
|
(15,276 |
) |
Cash flows from
investing activities: |
|
|
|
Proceeds from sale of intellectual property |
|
400 |
|
|
|
- |
|
Investment in IPR&D |
|
- |
|
|
|
(660 |
) |
Cash acquired in merger |
|
- |
|
|
|
4 |
|
Net cash used in investing activities |
|
400 |
|
|
|
(656 |
) |
Cash flows from
financing activities: |
|
|
|
Proceeds from sale of common stock, net of fees and offering costs,
$49 and $47 respectively |
|
1,597 |
|
|
|
46 |
|
Proceeds from public offering of common stock and warrants net of
underwriters discount and offering costs of $2,075 and $727
respectively |
|
21,456 |
|
|
|
5,303 |
|
Proceeds from induced exercise of warrants, net of costs of
$359 |
|
3,526 |
|
|
|
- |
|
Proceeds from voluntary exercise of warrants |
|
1,223 |
|
|
|
5 |
|
Payments made on notes payable |
|
(1,650 |
) |
|
|
- |
|
Cash paid for fractional shares |
|
(10 |
) |
|
|
Net cash provided by financing activities |
|
26,142 |
|
|
|
5,354 |
|
Effect of exchange rate
changes on cash |
|
- |
|
|
|
(4 |
) |
Net change in cash |
|
1,293 |
|
|
|
(10,582 |
) |
Cash and cash equivalents at
beginning of year |
|
1,285 |
|
|
|
11,867 |
|
Cash and cash equivalents at
end of year |
$ |
2,578 |
|
|
$ |
1,285 |
|
Supplemental
disclosure of cash flow information: |
|
|
|
Cash paid during period for interest |
$ |
404 |
|
|
$ |
15 |
|
Supplemental
disclosure of non-cash transactions: |
|
|
|
Fair value of common stock, stock options and stock warrants issued
as consideration for asset acquisition |
$ |
- |
|
|
$ |
9,605 |
|
Adjustment for the value offered to induce warrant exercise |
$ |
9,140 |
|
|
$ |
- |
|
|
|
|
|
|
|
|
|
Panbela Therapeutics (NASDAQ:PBLA)
과거 데이터 주식 차트
부터 4월(4) 2024 으로 5월(5) 2024
Panbela Therapeutics (NASDAQ:PBLA)
과거 데이터 주식 차트
부터 5월(5) 2023 으로 5월(5) 2024