Panbela Therapeutics, Inc. (Nasdaq: PBLA), a
clinical stage biopharmaceutical company developing disruptive
therapeutics for the treatment of patients with urgent unmet
medical needs, today announced it has entered into agreements with
certain holders of its existing warrants exercisable for 2,130,000
shares of its common stock, in the aggregate, to exercise their
warrants at a reduced exercise price of $0.78 per share, in
exchange for new warrants as described below. The aggregate gross
proceeds from the exercise of the existing warrants is expected to
total approximately $1.9 million, before deducting financial
advisory fees. The reduction in the exercise price of the existing
warrants and the issuance of the new warrants was structured as an
at-market transaction under Nasdaq rules.
Roth Capital Partners is acting as the company’s
financial advisor for this transaction.
The shares of common stock issuable upon
exercise of the existing warrants are registered pursuant to a
registration statement on Form S-1 (File No.333-271729) which
was declared effective by the Securities and Exchange Commission
(“SEC”) on June 15, 2023.
In consideration for the immediate exercise of
the existing warrants for cash and the payment of $0.125 per share
underlying the existing warrants, the exercising holders will
receive new warrants to purchase shares of common stock in a
private placement pursuant to Section 4(a)(2) of the
Securities Act of 1933, as amended (the “1933 Act”). Subject to the
receipt of stockholder approval for the issuance of the underlying
shares of common stock, the new warrants will be exercisable into
an aggregate of up to 4,260,000 shares of common stock, at an
exercise price of $0.78 per share and have a term of exercise equal
to five years after stockholder approval. The new warrants and
underlying shares of common stock have not been registered under
the Securities Act of 1933, as amended, or applicable state
securities laws. Accordingly, the securities may not be offered or
sold in the United States except pursuant to an effective
registration statement or an applicable exemption from the
registration requirements of the Securities Act and such applicable
state securities laws. As part of the transaction, the company has
agreed to file a resale registration statement with the SEC to
register the resale of the shares of common stock underlying the
new warrants.
This press release does not constitute an offer
to sell or the solicitation of an offer to buy these securities,
nor shall there be any sale of these securities in any jurisdiction
in which such offer, solicitation or sale would be unlawful prior
to the registration or qualification under the securities laws of
any such jurisdiction.
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
Statements This 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,” “can,” “continue,”
“design,” “expect,” “focus,” “intend,” “may,” “plan,” “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) our
ability to obtain any required stockholder approvals of the share
issuances and (xiii) 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.
Additional Information and Where to Find It;
Participants in the Solicitation
In connection with the proposed issuance of the shares
underlying the new warrants, Panbela Therapeutics, Inc. (the
“Company”) intends to file relevant materials with the SEC,
including a proxy statement. Following the filing of the definitive
proxy statement with the SEC, the Company will distribute the
definitive proxy statement and a proxy card to each stockholder
entitled to vote at the stockholder meeting relating to the
proposed issuance. The proxy statement, any other relevant
documents, and all other materials filed with the SEC concerning
the Company are (or, when filed, will be) available free of charge
at http://www.sec.gov and
https://panbela.com/investor-relations/financial-information/.
Stockholders should carefully read the proxy statement and any
other relevant documents that the Company files with the SEC when
they become available before making any voting decision because
they will contain important information.
This communication does not constitute a solicitation of proxy,
an offer to purchase, or a solicitation of an offer to sell any
securities. The Company’s directors and executive officers are
deemed to be participants in the solicitation of proxies from
stockholders in connection with the proposed issuance. Information
regarding the names of such persons and their respective interests
(if any) in the issuance will be set forth in the definitive proxy
statement when it is filed with the SEC. Additional information
regarding these individuals is set forth in our annual report on
Form 10-K for the fiscal year ended December 31, 2022, as amended.
To the extent the Company’s directors and executive officers or
their holdings of the Company’s securities have changed from the
amounts disclosed in those filings, to the Company’s knowledge,
such changes have been reflected on initial statements of
beneficial ownership on Form 3 or statements of change in ownership
on Form 4 on file with the SEC. These materials are (or, when
filed, will be) available free of charge at
https://panbela.com/investor-relations/financial-information/.
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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