Panbela to Host Third Quarter 2023 Earnings Conference Call on November 9, 2023
24 Outubro 2023 - 9:15AM
Panbela Therapeutics, Inc. (Nasdaq: PBLA), a
clinical stage company developing disruptive therapeutics for the
treatment of patients with urgent unmet medical needs, today
announced that it will host a conference call on November 9, 2023,
at 4:30 PM Eastern Time to discuss results for its third quarter
ended September 30, 2023.
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: 48679Webcast
replay: https://www.webcaster4.com/Webcast/Page/2556/49149
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 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), 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 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,” “believe,” “can,”
“design,” “expect,” “focus,” “intend,” “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; 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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