On January 26, 2023 Panbela Therapeutics, Inc. (Nasdaq: PBLA), ("Panbela" or the "Company"), a clinical stage company developing disruptive therapeutics for the treatment of patients with urgent unmet medical needs, reported the pricing of a public offering 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 Warrant (Press release, Panbela Therapeutics, JAN 26, 2023, View Source [SID1234626598]). The Public Warrants will have an exercise price of $2.75 per share, are exercisable upon issuance, and will expire five years following the date of issuance. The offering is expected to close on or about January 30, 2023, subject to customary closing conditions.
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Roth Capital Partners is acting as lead placement agent and Maxim Group LLC is acting as coplacement agent of the offering.
Gross proceeds, before deducting placement agent fees and commissions and offering expenses, are expected to be approximately $15.0 million. The Company intends to use the net proceeds from the proposed 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 are being 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 an additional registration statement filed with the SEC on January 26, 2023 pursuant to Rule 462(b) under the Securities Act of 1933, as amended. The offering is being made solely by means of a prospectus. Copies of the accompanying prospectus relating to and describing the terms of the offering may be obtained, when available, 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].
This press release does not and shall not constitute an offer to sell or the solicitation of an offer to buy any securities, nor shall there be any sale of these securities in any state or other jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or other jurisdiction. Any offer, if at all, will be made only by means of a prospectus, including a prospectus supplement, forming a part of the effective registration statement.
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.
SBP-101 Ivospemin
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.