On February 13, 2023 Panbela Therapeutics, Inc. (Nasdaq: PBLA), ("Panbela"), a clinical stage company developing disruptive therapeutics for the treatment of patients with urgent unmet medical needs, reported that, primarily as a result of the January 30, 2023 closing of its public offering of approximately $15 million of common stock and warrants, Panbela has regained compliance with applicable listing standards of The Nasdaq Stock Market ("Nasdaq") (Press release, Panbela Therapeutics, FEB 13, 2023, View Source [SID1234627106]).

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Panbela Regains Nasdaq Compliance

Nasdaq has issued notice that Panbela has regained compliance for continued listing of its common stock. On February 9, 2023, Panbela received a letter from Nasdaq confirming that Panbela has cured the previously identified minimum bid price and stockholders’ equity deficiencies under Nasdaq Listing Rules 5550(a)(2) and 5550(b)(1), respectively, and that Panbela is in compliance with all applicable listing standards. Panbela’s previously scheduled delisting determination appeal hearing has been canceled, and its common stock will continue to be listed and traded on Nasdaq.

Panbela Closes $15 million Public Offering

On January 30, 2023, Panbela closed its previously announced public offering consisting of (i) 6,675,000 shares of its common stock (or pre-funded warrants in lieu thereof) and (ii) warrants to purchase up to 13,350,000 shares of its common stock (the "Public Warrants") at a purchase price of $2.25 per share and associated Public Warrants (or $2.249 per pre-funded warrant and associated Public Warrants). All of the pre-funded warrants have been exercised. The Public Warrants have a cash exercise price of $2.75 per share of common stock, were exercisable upon issuance, and will expire five years following the date of issuance. The Public Warrants also contain cashless exercise provisions, subject to certain conditions.

Roth Capital Partners acted as lead placement agent and Maxim Group LLC acted as coplacement agent of the offering.

Gross proceeds from the offering, before deducting placement agent fees and offering expenses, were approximately $15.0 million. Panbela intends to use the net proceeds from the offering for the continued clinical development of its product candidates ivospemin (SBP-101) and eflornithine (CPP-1X), working capital, business development and other general corporate purposes, which may include repayment of debt.

The securities described above were offered pursuant to a registration statement on Form S-1 (File No. 333-268854), as amended, that was declared effective by the U.S. Securities and Exchange Commission ("SEC"), on January 25, 2023, and a registration statement on Form S-1 (File No. 333-269421) filed pursuant to Rule 462(b) with the SEC on January 26, 2023. The offering was made solely by means of a prospectus. Copies of the prospectus relating to and describing the terms of the offering may be obtained at the SEC’s website at www.sec.gov or by contacting Roth Capital Partners, LLC, 888 San Clemente Drive, Suite 400, Newport Beach, CA 92660 or by email at [email protected].

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 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. For more information, please visit View Source

Flynpovi

Flynpovi is a combination of CPP-1X (eflornithine) and sulindac with a dual mechanism inhibiting polyamine synthesis and increase 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), Flynpovi 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 power 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 investigatorinitiated trials suggest that CPP-1X treatment may be well-tolerated and has potential activity.