MINNEAPOLIS, April 16, 2024 (GLOBE NEWSWIRE) — Panbela Therapeutics, Inc. (OTCQB: PBLA); Panvera (“Panvera”), a clinical-stage company developing disruptive therapies for the treatment of patients with urgent unmet medical needs, announced today that its common stock will be listed on the OTCQB Market. announced that it had been approved. Panbela's common stock is expected to be listed on his OTCQB under the symbol “PBLA” beginning April 17, 2024.
OTCQB is a venture market operated by OTC Markets Group Inc. To qualify for a quote on the OTCQB, companies must have up-to-date reporting and undergo an annual verification and management certification process. OTCQB is recognized by the U.S. Securities and Exchange Commission (“SEC”) as an established public market, providing up-to-date public information to investors who need to analyze, value, and trade securities.
Panbela's board of directors also approved the delisting of its common stock from the Nasdaq Stock Market LLC (“Nasdaq”). On April 16, 2024, Panvera notified Nasdaq of its decision to file a Form 25 with the SEC regarding the delisting of its common stock. Panvera intends to file its own Form 25 in advance of Nasdaq's expected Form 25 filing primarily to facilitate the transition of its common stock to OTCQB. Form 25 also serves to deregister Panvera's common stock under Section 12(b) of the Securities Exchange Act of 1934, as amended (the “Exchange Act”). As previously disclosed, on March 5, 2024, the Nasdaq Hearing Committee ordered Panvera to delist its common stock, and trading in Panvera's common stock on Nasdaq ceased on March 7, 2024. I have been notified that this has happened. We did not meet the minimum $2.5 million equity requirement of Listing Rule 5550(b)(1) and failed to comply with any of the alternative requirements of Listing Rule 5550(b).
Neither the filing of Form 25 nor the formal delisting of Panvera's common stock from Nasdaq is expected to affect the eligibility of our common stock for listing on the OTCQB.
About Panbela’s pipeline
The pipeline is currently in clinical trials with an initial focus on familial adenomatous polyposis (FAP), first-line metastatic pancreatic cancer, preoperative pancreatic cancer, colorectal cancer prevention, and ovarian cancer. It consists of assets. The integrated development program has a steady supply of promising catalysts, with programs ranging from preclinical to registration studies.
Ibospemin (SBP-101)
Ibospamine is a unique polyamine analog designed to induce polyamine metabolic inhibition (PMI), taking advantage of the compound's observed high affinity for pancreatic ductal adenocarcinoma and other tumors. A clinical study of patients with metastatic pancreatic cancer showed signals of tumor growth inhibition, with a median overall survival (OS) of 14.6 months and an objective response rate (ORR) of 48%, both typical of standard therapy. exceeds the value. The efficacy of gemcitabine plus nab-paclitaxel suggests potential complementary activity with existing FDA-approved standard chemotherapy regimens. In data evaluated from clinical studies to date, ibospemin has not shown worsening of myelosuppression and peripheral neuropathy, which are potential chemotherapy-related adverse events. Serious visual adverse events are being evaluated and patients with a history of retinopathy or at risk for retinal detachment will be excluded from future SBP-101 studies. The safety data and PMI profile observed in previous Panbela-sponsored clinical trials support the continued evaluation of ibospemin in the ASPIRE trial.
Frimpovy™
Flynpovi is a combination of CPP-1X (eflornithine) and sulindac with a dual mechanism of inhibiting polyamine synthesis and increasing polyamine export and catabolism. In a phase III clinical trial in patients with sporadic colorectal polyps, this combination prevented subsequent precancerous sporadic adenomas by more than 90% compared with placebo. A recent phase III trial comparing frimpovy with single-agent eflornithine and single-agent sulindac focused on FAP patients with lower gastrointestinal tract anatomy; patients with intact colon, residual rectum, or surgical pouch) showed a statistically significant benefit (p≤0.02) for lower surgical events in the lower gastrointestinal tract compared to both agents alone. Delayed for up to 4 years. The safety profile of Flynpovi was not significantly different from that of a single agent, supporting the continued evaluation of Flynpovi in FAP.
CPP-1X
CPP-1X (eflornithine) is being developed as a single-dose tablet or high-dose powder sachet for several indications, including gastric cancer prevention, neuroblastoma treatment, and recent-onset type 1 diabetes. Preclinical studies and Phase I or Phase II investigator-initiated trials suggest that CPP-1X treatment is well tolerated and may have potential activity.
About Panbera
Panbela Therapeutics, Inc. is a clinical-stage biopharmaceutical company developing innovative treatments for patients with urgent unmet medical needs. Panbela's main assets are Ivospemin (SBP-101) and Flynpovi. For more information, please visit: www.panbera.com . Panbela's common stock will be available for listing on the OTCQB under the symbol “PBLA” starting April 16, 2024.
Cautionary note regarding forward-looking statements
This press release contains “forward-looking statements” that may be forward-looking statements, including “anticipate,” “believe,” “could,” “design,” “anticipate,” “focus,” ” It can be identified by words such as “intend'' and “consider.'' “Forward,'' “may,'' “plan,'' “position,'' “possibility,'' and “plan.'' All statements other than statements of historical fact should be considered forward-looking statements. Forward-looking statements are neither historical facts nor guarantees of future performance. Instead, they are based solely 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 beyond our control. Our actual results of operations and financial condition may differ materially and adversely from any forward-looking statements. Therefore, you should not rely on these forward-looking statements. Important factors that could cause our actual results of operations and financial condition to differ materially from those expressed in the forward-looking statements include, among others: (i) our ability to obtain additional funding to execute our business and clinical development plans; (ii) the progress and success of our clinical development programs; (iii) the impact of the current COVID-19 pandemic on our ability to conduct clinical trials; (iv) our ability to demonstrate the safety and efficacy of our product candidates ibospemin (SBP-101) and eflornithine (CPP-1X); (v) our reliance on third parties to conduct registration studies for our product candidate Flynpovi; (vi) our ability to obtain regulatory approval in the United States, European Union or other international markets for our product candidates SBP-101 and CPP-1X; (vii) market acceptance and future sales levels of our product candidates, SBP-101 and CPP-1X; (viii) product development costs and delays 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 impact of competing technological and market developments; (xi) costs of filing and prosecuting patent applications and enforcing or defending patent claims; (xii) our ability to obtain listing of our common stock on a national securities exchange; (xiii) other factors discussed in Part I, Item 1A under the caption “Risk Factors” in our most recent Annual Report on Form 10-K, our Quarterly Reports on Form 10-Q and Additional risks described in our current quarterly reports on Form 8-K. The forward-looking statements we make in this press release are based on information currently available to us and speak only as of the date hereof. The Company does not warrant any forward-looking statements, whether written or oral, whether as a result of new information, future developments or otherwise, and that actual results will not be as anticipated in the forward-looking statements. We are not obligated to publicly update any different reasons.
contact address:
Investor:
james carbonara
Hayden IR
(646) 755-7412
james@haydenir.com
media:
Tammy Groene
Panbela Therapeutics, Inc.
(952) 479-1196
IR@panbela.com
