On February 22, 2022 Panbela Therapeutics, Inc. (Nasdaq: PBLA), a clinical stage company developing disruptive therapeutics for the treatment of patients with cancer, reported it has entered into a definitive agreement to acquire Cancer Prevention Pharmaceuticals, Inc. ("CPP"), a private clinical stage company developing therapeutics to reduce the risk and recurrence of cancer and rare diseases, for a combination of stock and future milestone payments (Press release, Panbela Therapeutics, FEB 22, 2022, View Source;utm_medium=rss&utm_campaign=panbela-therapeutics-inc-to-acquire-cancer-prevention-pharmaceuticals-inc [SID1234608808]).
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Strategic Rationale and Benefits of the Transaction
The combined entity will have an expanded pipeline addressing an estimated aggregate $5 billion market opportunity for the areas of initial focus: familial adenomatous polyposis (FAP), first-line metastatic pancreatic cancer, neoadjuvant pancreatic cancer, colorectal cancer prevention and ovarian cancer. The combined development programs boast a steady cadence of catalysts with programs ranging from pre-clinical to registration studies, including CPP’s lead asset with a fully funded registration trial scheduled to begin this year. In addition, the transaction facilitates operational and commercial synergies, under the leadership of a highly experienced management team with a proven history of drug discovery, development, and commercialization expertise. "This transaction is an important step towards our goal of creating a diversified pipeline with an ability to hit multiple targets and thereby expanding the potential of the combined company," said Jennifer K. Simpson, PhD, MSN, CRNP, President & Chief Executive Officer of Panbela. "The combined platforms will be better positioned to treat more patients. This transaction is a tremendous strategic fit and we feel creates robust stockholder value."
CPP co-founder and CEO, Jeff Jacob, stated, "I strongly believe Panbela is the right choice to carry our efforts forward and continue the outstanding work our team has done to build our clinical stage orphan and oncology pipeline into what it is today and to continue the development of Flynpovi, our lead asset. Flynpovi, a combination of CPP-1X (eflornithine) and sulindac has a dual mechanism both inhibiting polyamine synthesis and increased polyamine export and catabolism. By leveraging the established infrastructure of Panbela, we expect to continue to expand our pipeline. After a full assessment of strategic alternatives, our Board of Directors believes the transactions signifies the best value opportunity for CPP stakeholders."
CPP is developing therapeutics designed to reduce the risk of cancer and other diseases. In addition to the fully funded FAP registration trial scheduled to begin by year-end, a phase 3 trial in colon cancer survivors is currently underway and is sponsored by the Southwest Oncology Group (SWOG). Additionally, clinical trials in neuroblastoma, gastric cancer, and early-onset type-1 diabetes are underway in collaboration with various nonprofit groups.
Transaction Details
Under the terms of the agreement and plan of merger, the holders of CPP’s outstanding capital stock immediately prior to the merger will receive shares of common stock of Panbela upon closing of the mergers. On a pro forma and fully diluted basis, holders of Panbela common stock are expected to own approximately 59% of the post-merger holding company and holders of CPP securities, including converted indebtedness, are expected to beneficially own approximately 41% of post-merger holding company. CPP stockholders will be eligible to receive contingent payments totaling a maximum of $60 million from milestone and royalty payments associated with the potential approval and commercialization of the lead asset.
The proposed mergers have been unanimously approved by the boards of directors of each company and the stockholders of CPP. A closing is expected to occur by the second quarter of 2022, subject to approval of the issuance of securities in the transactions by Panbela’s stockholders, and satisfaction of other customary closing conditions.
Additional Information
The combined company will be led by Jennifer Simpson, Chief Executive Officer of Panbela and will remain headquartered in Waconia, Minnesota. The board of the combined company is expected to optimize the value of this transaction and beyond and will include at least two members initially designated by CPP, CPP Chief Executive Officer, Jeff Jacob, and CPP Director, Dan Donovan.
Canaccord Genuity LLC is acting as the exclusive financial advisor to Panbela, and Faegre Drinker Biddle & Reath LLP is acting as its legal counsel. The Sage Group is acting as the exclusive financial advisor to CPP, and Blank Rome LLP is acting as its legal counsel.
About: SBP-101
SBP-101 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. The molecule has shown signals of tumor growth inhibition in clinical studies of US and Australian metastatic pancreatic cancer patients, demonstrating a median overall survival (OS) of 12.0 months which is not yet final, and an objective response rate (ORR) of 48%, both exceeding what is seen typically with 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, SBP-101 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 current Panbela sponsored clinical trial provides support for continued evaluation of SBP-101 in a randomized clinical trial. For more information, please visit View Source .