Panbela Therapeutics, Inc. (Nasdaq: PBLA), a clinical stage company
developing disruptive therapeutics for the treatment of patients
with urgent unmet medical needs, today announced the pricing of a
public offering of (i) 4,375,000 shares of its common stock or
pre-funded warrants in lieu thereof and (ii) two classes of
warrants to purchase up to an aggregate of 8,750,000 shares of its
common stock (the “Common Warrants”) at a purchase price of $2.06
per share and associated Common Warrants. The Common Warrants will
have an exercise price of $2.06 per share, are exercisable upon
issuance, and will expire five years following the date of
issuance. The Common Warrants do not have any alternative cashless
exercise or other provisions to adjust their exercise price beyond
customary proportionate adjustments for recapitalizations and
similar events. The offering is expected to close on or about
January 31, 2024, subject to customary closing conditions.
Roth Capital Partners is acting as sole placement agent of the
offering.
Gross proceeds, before deducting placement agent fees and
commissions and offering expenses, are expected to be approximately
$9.0 million. The company intends to use the net proceeds from the
offering for the continued clinical development of its product
candidates, working capital, business development and other general
corporate purposes, which may include repayment of debt.
The securities described above are being offered pursuant to a
registration statement on Form S-1 (File No. 333-276367), as
amended, that was declared effective by the U.S. Securities and
Exchange Commission (“SEC”), on January 26, 2024. The offering is
being made solely by means of a prospectus. Copies of the
accompanying prospectus relating to and describing the terms of the
offering may be obtained, when available, at the SEC’s website at
www.sec.gov or by contacting Roth Capital Partners, LLC, 888 San
Clemente Drive, Suite 400, Newport Beach, CA 92660 or by email at
rothecm@roth.com.
This press release does not and shall not constitute an offer to
sell or the solicitation of an offer to buy any securities, nor
shall there be any sale of these securities in any state or other
jurisdiction in which such offer, solicitation or sale would be
unlawful prior to registration or qualification under the
securities laws of any such state or other jurisdiction. Any offer,
if at all, will be made only by means of a prospectus, including a
prospectus supplement, forming a part of the effective registration
statement.
About Panbela’s 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 and ovarian cancer. The combined
development programs have a steady cadence of anticipated catalysts
with programs ranging from pre-clinical to registration
studies.
Ivospemin (SBP-101)Ivospemin 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.
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 III 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 III 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), 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-1XCPP-1X (eflornithine) is being developed
as a single agent tablet or high dose powder sachet for several
indications including prevention of gastric cancer, treatment of
neuroblastoma and recent onset Type 1 diabetes. Preclinical studies
as well as Phase I or Phase II 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,” “believe,” “can,”
“design,” “expect,” “focus,” “intend,” “looking forward,” “may,”
“plan,” “positioned,” “potential,” and “will.” 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) progress and success
of our clinical development program; (iii) the impact of the
current COVID-19 pandemic on our ability to conduct our clinical
trials; (iv) our ability to demonstrate the safety and
effectiveness of our product candidates: ivospemin (SBP-101) and
eflornithine (CPP-1X); (v) our reliance on a third party for the
execution of the registration trial for our product candidate
Flynpovi ; (vi) our ability to obtain regulatory approvals for our
product candidates, SBP-101 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 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 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; (xii) our ability to maintain the listing of our common
stock on a national securities exchange; (xiii) satisfaction of
applicable closing conditions for the offering, and (xiv) 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
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