MINNEAPOLIS, April 16, 2024 (GLOBE NEWSWIRE) -- 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 Pipeline
The 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-1X
CPP-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.