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 September 30, 2023. As
previously announced, management is hosting an earnings call today
at 4:30 p.m. ET.
Q3 2023 and Recent Highlights
Collaborations
- 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.
Clinical
- 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 recommended that the study continue without
modification.
- Opened enrollment
in the UK and Germany and have all planned countries in the ASPIRE
trial for pancreatic cancer now open and actively enrolling.
- Entered into a
clinical trial agreement for a Phase 2 trial in castration
resistant metastatic prostate cancer (mCRPC) which is actively
enrolling.
Financial/Business
- Last week, certain
holders of our existing warrants exercised for an aggregate
2,130,000 shares of common stock at a reduced exercise price of
$0.78 per share, in exchange for receiving new warrants, the
exercisability of which remains subject to stockholder approval.
The aggregate gross proceeds from the exercise of the existing
warrants totaled approximately $1.9 million, before deducting
financial advisory fees.
- Issued a new
patent in China for claims of a novel process for the production of
ivospemin (SBP-101). Patent developed in collaboration with Syngene
International Ltd.
- Issued a new
patent in Chile for claims of a novel process for the production of
Flynpovi, Patent developed in collaboration with Sanofi.
- Issued a new
patent in Australia for claims of a novel process for the
production of ivospemin (SBP-101).
"In the third quarter, we achieved important milestones and
advanced our robust product pipeline, primarily funded through
strategic collaboration. Notably, our Phase III ASPIRE trial for
untreated metastatic pancreatic ductal adenocarcinoma received a
favorable safety review from the independent DSMB, recommending no
changes to the trial protocol. We have opened enrollment in the UK
and Germany, and now have all planned countries in the ASPIRE trial
open and actively enrolling," said Jennifer K. Simpson, PhD, MSN,
CRNP, President & CEO of Panbela. "Additionally, we fortified
our intellectual property portfolio, obtaining patents in China,
Chile, and Australia. Moreover, we finalized an agreement for up to
$9.5M in non-dilutive funding through the divestiture of our
neuroblastoma program to our strategic partner, US WorldMeds, who
recently received a positive vote from the Oncologic Drugs Advisory
Committee (ODAC) meeting on October 4, 2023.”
Dr. Simpson added, “Looking ahead, Panbela remains committed to
delivering value for both patients and shareholders. We are moving
towards a number of upcoming catalysts, including the release of
ASPIRE interim data around mid-year 2024."
Third Quarter ended September 30, 2023 Financial
Results
General and administrative expenses were $1.1 million in the
third quarter of 2023, compared to $1.3 million in the third
quarter of 2022. The change is primarily due to decreased legal and
financial services costs.
Research and development expenses were $6.7 million in the third
quarter of 2023, compared to $2.3 million in the third quarter of
2022. The increase is primarily due to the cost of approximately
$3.2 million or approximately 6 months’ supply of Abraxane, a
standard of care drug, used in the ASPIRE clinical trial and first
made available to the clinical sites during the three months ended
September 30, 2023. The remaining increase is associated with other
ASPIRE clinical trial costs.
Net loss in the third quarter of 2023 was $7.8 million, or $2.69
per diluted share, compared to a net loss of $4.4 million, or
$257.36 per diluted share, in the third quarter of 2022. All share
and per share amounts have been restated for two reverse stock
splits which occurred in the nine months ended September 30,
2023.
Total cash was $0.9 million as of September 30, 2023. Total
current assets were $1.9 million and current liabilities were $8.9
million as of the same date. Notes payable, plus accrued interest,
on the balance sheet, which was the result of the acquisition of
CPP, included 1.2 million in current liabilities and 4.2 in debt,
net of current portion.
Conference Call InformationTo participate in
this event, dial approximately 5 to 10 minutes before the beginning
of the call.Date: November 9,
2023Time: 4:30 PM Eastern
TimeParticipant Numbers: Toll Free:
888-506-0062; Code:
100225International: 973-528-0011; Code:
100225Webcast: https://www.webcaster4.com/Webcast/Page/2556/49149
Conference Call Replay InformationToll
Free: 877-481-4010International: 919-882-2331Replay
Passcode: 49149Webcast
replay: https://www.webcaster4.com/Webcast/Page/2556/49149
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”.
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 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 September 30, |
|
Nine months ended September 30, |
|
|
|
2023 |
|
|
|
2022 |
|
|
Percent Change |
|
|
2023 |
|
|
|
2022 |
|
|
Percent Change |
Operating expenses: |
|
|
|
|
|
|
|
|
|
|
|
|
General and administrative |
|
$ |
1,107 |
|
|
$ |
1,294 |
|
|
-14.5 |
% |
|
$ |
4,102 |
|
|
$ |
4,349 |
|
|
-5.7 |
% |
Research and development |
|
|
6,739 |
|
|
|
2,329 |
|
|
189.4 |
% |
|
|
14,501 |
|
|
|
24,563 |
|
|
-41.0 |
% |
Operating loss |
|
|
(7,846 |
) |
|
|
(3,623 |
) |
|
116.6 |
% |
|
|
(18,603 |
) |
|
|
(28,912 |
) |
|
-35.7 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
Other income (expense): |
|
|
|
|
|
|
|
|
|
|
|
|
Interest income |
|
|
49 |
|
|
|
6 |
|
|
- |
|
|
|
114 |
|
|
|
10 |
|
|
1040.0 |
% |
Gain on sale of intellectual property |
|
|
400 |
|
|
|
- |
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
- |
|
Interest expense |
|
|
(71 |
) |
|
|
(87 |
) |
|
-18.4 |
% |
|
|
(245 |
) |
|
|
(107 |
) |
|
129.0 |
% |
Other income (expense) |
|
|
(382 |
) |
|
|
(754 |
) |
|
-49.3 |
% |
|
|
(622 |
) |
|
|
(1,293 |
) |
|
-51.9 |
% |
Total other income (expense) |
|
|
(4 |
) |
|
|
(835 |
) |
|
-99.5 |
% |
|
|
(753 |
) |
|
|
(1,390 |
) |
|
-45.8 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
Loss before income tax
benefit |
|
|
(7,850 |
) |
|
|
(4,458 |
) |
|
76.1 |
% |
|
|
(19,356 |
) |
|
|
(30,302 |
) |
|
-36.1 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
Income tax benefit |
|
|
19 |
|
|
|
56 |
|
|
-66.1 |
% |
|
|
167 |
|
|
|
104 |
|
|
60.6 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss |
|
|
(7,831 |
) |
|
|
(4,402 |
) |
|
77.9 |
% |
|
|
(19,189 |
) |
|
|
(30,198 |
) |
|
-36.5 |
% |
Foreign currency translation
adjustment |
|
|
381 |
|
|
|
727 |
|
|
-47.6 |
% |
|
|
612 |
|
|
|
1,240 |
|
|
-50.6 |
% |
Comprehensive Loss |
|
$ |
(7,450 |
) |
|
$ |
(3,675 |
) |
|
102.7 |
% |
|
$ |
(18,577 |
) |
|
$ |
(28,958 |
) |
|
-35.8 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic and diluted net loss per
share |
|
$ |
(2.69 |
) |
|
$ |
(257.36 |
) |
|
-99.0 |
% |
|
$ |
(14.35 |
) |
|
$ |
(2,255.96 |
) |
|
-99.4 |
% |
Weighted average shares
outstanding - basic and diluted |
|
|
2,914,600 |
|
|
|
17,107 |
|
|
16937.5 |
% |
|
|
1,309,137 |
|
|
|
13,386 |
|
|
9679.9 |
% |
Panbela Therapeutics, Inc.Consolidated
Balance Sheets (unaudited)(In thousands, except share
amounts)
|
|
|
|
|
|
|
September 30, 2023 |
|
December 31, 2022 |
ASSETS |
|
(Unaudited) |
|
|
Current assets: |
|
|
|
|
Cash and cash equivalents |
|
$ |
907 |
|
|
$ |
1,285 |
|
Prepaid expenses and other current assets |
|
|
824 |
|
|
|
443 |
|
Income tax receivable |
|
|
155 |
|
|
|
49 |
|
Total current assets |
|
|
1,886 |
|
|
|
1,777 |
|
Other non-current assets |
|
|
8,742 |
|
|
|
3,201 |
|
Total assets |
|
$ |
10,628 |
|
|
$ |
4,978 |
|
|
|
|
|
|
LIABILITIES AND STOCKHOLDERS' DEFICIT |
|
|
|
|
Current liabilities: |
|
|
|
|
Accounts payable |
|
$ |
6,612 |
|
|
$ |
2,865 |
|
Accrued expenses |
|
|
1,133 |
|
|
|
2,993 |
|
Accrued interest payable |
|
|
172 |
|
|
|
325 |
|
Note payable |
|
|
- |
|
|
|
650 |
|
Debt, current portion |
|
|
1,000 |
|
|
|
1,000 |
|
Total current liabilities |
|
|
8,917 |
|
|
|
7,833 |
|
|
|
|
|
|
Debt, net of current portion |
|
|
4,194 |
|
|
|
5,194 |
|
Total non-current
liabilities |
|
|
4,194 |
|
|
|
5,194 |
|
|
|
|
|
|
Total liabilities |
|
|
13,111 |
|
|
|
13,027 |
|
|
|
|
|
|
Stockholders' deficit: |
|
|
|
|
Preferred stock, $0.001 par value; 10,000,000 authorized; no shares
issued or outstanding as of September 30, 2023 and December 31,
2022 |
|
|
- |
|
|
|
- |
|
Common stock, $0.001 par value; 100,000,000 authorized; 2,996,753
and 34,761 shares issued, and 2,996,334 and 34,761 outstanding as
of September 30, 2023 and December 31, 2022, respectively |
|
|
3 |
|
|
|
- |
|
Treasury Stock at cost; 419 and 0 shares as of September 30, 2023
and December 31, 2022, respectively |
|
|
- |
|
|
|
- |
|
Additional paid-in capital |
|
|
106,026 |
|
|
|
82,286 |
|
Accumulated deficit |
|
|
(109,883 |
) |
|
|
(91,094 |
) |
Accumulated comprehensive income |
|
|
1,371 |
|
|
|
759 |
|
Total stockholders'
deficit |
|
|
(2,483 |
) |
|
|
(8,049 |
) |
Total liabilities and
stockholders' deficit |
|
$ |
10,628 |
|
|
$ |
4,978 |
|
|
|
|
|
|
Panbela Therapeutics,
Inc.Consolidated Statements of Cash
Flows (unaudited)(In thousands)
|
|
Nine Months Ended September 30, |
|
|
|
2023 |
|
|
|
2022 |
|
Cash flows from
operating activities: |
|
|
|
|
Net loss |
|
$ |
(18,789 |
) |
|
$ |
(30,198 |
) |
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 |
|
|
699 |
|
|
|
857 |
|
Non-cash interest expense |
|
|
172 |
|
|
|
97 |
|
Gain on sale of intellectual property |
|
|
(400 |
) |
|
|
- |
|
Changes in operating assets and liabilities: |
|
|
|
|
Income tax receivable |
|
|
(112 |
) |
|
|
302 |
|
Prepaid expenses and other current assets |
|
|
(381 |
) |
|
|
(451 |
) |
Other non-current assets |
|
|
(5,541 |
) |
|
|
(2,561 |
) |
Accounts payable |
|
|
4,370 |
|
|
|
5,392 |
|
Accrued liabilities |
|
|
(2,187 |
) |
|
|
(1,448 |
) |
Net cash used in operating activities |
|
|
(22,169 |
) |
|
|
(10,273 |
) |
|
|
|
|
|
Cash flows from
investing activities: |
|
|
|
|
Investment in IPR&D |
|
|
- |
|
|
|
(660 |
) |
Proceeds from sale of intellectual property |
|
|
400 |
|
|
|
- |
|
Cash acquired in merger |
|
|
- |
|
|
|
4 |
|
Net cash used in investing activities |
|
|
400 |
|
|
|
(656 |
) |
Cash flows from
financing activities: |
|
|
|
|
Proceeds from sale of common stock and warrants, net of $2.1
million of offering costs |
|
|
23,052 |
|
|
|
- |
|
Cash paid for fractional shares |
|
|
(9 |
) |
|
|
- |
|
Proceeds from exercise of stock purchase warrants |
|
|
- |
|
|
|
5 |
|
Principal payments on notes |
|
|
(1,650 |
) |
|
|
- |
|
Net cash provided by financing activities |
|
|
21,393 |
|
|
|
5 |
|
|
|
|
|
|
Effect of exchange rate
changes on cash |
|
|
(2 |
) |
|
|
(2 |
) |
|
|
|
|
|
Net change in cash |
|
|
(378 |
) |
|
|
(10,926 |
) |
Cash and cash equivalents at
beginning of period |
|
|
1,285 |
|
|
|
11,867 |
|
Cash and cash equivalents at
end of period |
|
$ |
907 |
|
|
$ |
941 |
|
|
|
|
|
|
Supplemental
disclosure of cash flow information: |
|
|
|
|
Cash paid during period for interest |
|
$ |
398 |
|
|
$ |
9 |
|
|
|
|
|
|
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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