Panbela Announces Transfer to OTCQB Market
17 April 2024 - 7:29AM
Panbela Therapeutics, Inc. (OTCQB: PBLA), (“Panbela”), a
clinical stage company developing disruptive therapeutics for the
treatment of patients with urgent unmet medical needs, today
announced that its common stock has been approved for quotation on
the OTCQB market. Panbela’s common stock will be eligible for
quotation on the OTCQB starting on April 17, 2024, under the
symbol “PBLA.”
OTCQB is a venture market operated by the OTC Markets Group Inc.
To be eligible for quotation on the OTCQB, companies must be
current in their reporting and undergo an annual verification and
management certification process. OTCQB is recognized by the U.S.
Securities and Exchange Commission (the “SEC”) as an established
public market and provides current public information to investors
who need to analyze, value, and trade securities.
Panbela’s board of directors also has approved the delisting of
its common stock from The Nasdaq Stock Market LLC (“Nasdaq”). On
April 16, 2024, Panbela notified Nasdaq of its determination to
file with the SEC a Form 25 relating to the delisting of its common
stock. Panbela intends to file its own Form 25 in advance of
Nasdaq’s expected filing of a Form 25, primarily to expedite the
transition of its common stock to the OTCQB. The Form 25 will also
serve to deregister Panbela’s common stock under Section 12(b) of
the U.S. Securities Exchange Act of 1934, as amended (the “Exchange
Act”). As previously disclosed, on March 5, 2024, a Nasdaq hearings
panel notified Panbela that it had determined to delist its common
stock and trading of Panbela’s common stock on Nasdaq was suspended
on March 7, 2024. The panel reached its decision because our
company did not satisfy the minimum $2.5 million stockholders’
equity requirement in Listing Rule 5550(b)(1) and was unable to
comply with any of the alternative requirements in Listing Rule
5550(b).
Neither the filing of the Form 25 nor the official delisting of
Panbela’s common shares from Nasdaq is expected to impact the
eligibility of our common shares for quotation on the OTCQB.
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 will be eligible for quotation on the OTCQB under the
symbol “PBLA”, starting April 16, 2024.
Cautionary Statement Regarding Forward-Looking
StatementsThis press release contains “forward-looking
statements,” which 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 obtain a listing of
our common stock on a national securities exchange; 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.
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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