CohBar, Inc. and Morphogenesis, Inc. Enter into Definitive Merger Agreement to Advance an Innovative Late-stage Clinical Immuno-oncology Pipeline of Therapies to Overcome Resistance to Cancer Immunotherapy
Combined company will operate under the name “TuHURA Biosciences, Inc.” and advance a personalized cancer vaccine platform and preclinical tumor microenvironment modulators
Lead asset, IFx-Hu2.0, expected to enter Phase 2/3 registration trial as first-line treatment for Merkel Cell Carcinoma in early 2024
$15 million PIPE financing to close concurrent with the closing of the proposed merger – combined company expected to have cash runway through 2024
Companies to hold a joint conference call and webcast today, Tuesday, May 23rd at 8:30 AM ET
MENLO PARK, Calif. and TAMPA, Fla. , May 23, 2023 (GLOBE NEWSWIRE) -- CohBar, Inc. (NASDAQ: CWBR) (“CohBar” or the “company”) and Morphogenesis, Inc. (“Morphogenesis”), a privately-held Phase 2/3 clinical-stage biotechnology company developing novel personalized cancer vaccines and tumor microenvironment modulators to overcome resistance to current immunotherapies, today announced that they have entered into a definitive agreement for an all-stock transaction forming a company combining expertise and resources to advance a late-stage oncology pipeline. The combined company will focus on advancing Morphogenesis’ two technologies that seek to overcome the major obstacles that limit the effectiveness of current immunotherapies in treating cancer. The combined company is expected to operate under the name “TuHURA Biosciences, Inc.” and to trade on The Nasdaq Capital Market (“Nasdaq”). The transaction is expected to close in the third quarter of 2023.
“Following a thorough review and evaluation, we believe merging with Morphogenesis and leveraging their late-stage pipeline of novel immuno-oncology technologies represents the best path forward for our stockholders and has the potential to deliver near and long-term value,” stated Dr. Joseph Sarret, CEO of CohBar. “Our board and management team believe that the combined company will be well-positioned to develop powerful new therapies with the potential to overcome resistance to current immunotherapies, an area of significant unmet need.”
Morphogenesis’ technologies, which can be used to target large unmet medical needs across a variety of cancers, include:
Immune Fx (IFx) Personalized Cancer Vaccines: IFx is designed to prime and activate an innate immune response against patient-specific tumor antigens, overcoming primary resistance to checkpoint inhibitors. Morphogenesis is currently preparing for a single Phase 2/3 registration trial of its lead personalized cancer vaccine, IFx-Hu2.0, as an adjunct to Keytruda® (pembrolizumab) in first line treatment for advanced Merkel Cell Carcinoma (MCC). This study is expected to be conducted under a Special Protocol Assessment (SPA) agreement with the FDA and to commence in early 2024. Additionally, Morphogenesis is advancing IFx-Hu3.0, its mRNA vaccine, toward IND-enabling studies in 2024 for the treatment of aggressive diffuse large B-cell lymphoma (DLBCLs).
Tumor Microenvironment (TME) Modulators: TME Modulators are designed to address one of the primary causes of acquired resistance to immunotherapies, including checkpoint inhibitors or cellular therapies like CAR-T. Leveraging its new class of novel bi-functional antibody drug conjugates (ADCs), Morphogenesis is targeting a recently identified delta receptor on myeloid derived suppressor cells (MDSCs). MDSCs comprise a major component of cells in the tumor microenvironment and are responsible for suppressing the immune system’s attack against the tumor. Morphogenesis is constructing several MDSC targeted, bi-functional ADCs for in vitro and in vivo characterization, targeting lead selection by the end of 2024.
"I’m extremely pleased to announce this proposed merger with CohBar, which comes at a pivotal time for Morphogenesis,” said Dr. James Bianco, Chief Executive Officer of Morphogenesis. “We are gearing up to initiate our Phase 2/3 registration study for IFx-Hu2.0 early next year. Our technology platforms have the potential to significantly increase the number of cancer patients that respond to immunotherapies, such as checkpoint inhibitors. This transaction serves as a significant next step in the advancement of our important mission.”
About the Proposed Transaction, Management & Organization
Under the terms of the merger agreement, subject to stockholder approval, each holder of CohBar common stock as of immediately prior to the closing of the transaction will be issued a dividend equal to approximately 3.30 shares of CohBar common stock on or about the effective date of the merger. On a pro forma basis taking into account the concurrent financing described below and the issuance of the stock dividend, pre-merger CohBar equityholders are expected to collectively own approximately 15% and pre-merger Morphogenesis equityholders are expected to collectively own approximately 77%, respectively, of the common stock of CohBar on a pro forma basis (assuming the exercise of all in-the-money warrants and options then outstanding).
Upon execution of the merger agreement, CohBar also entered into a stock purchase agreement with an affiliate of an existing investor in Morphogenesis for a $15 million private placement that is expected to close concurrently with the closing of the proposed merger. The proceeds from the private placement will be used to fund the advancement of the combined company’s immunotherapy-focused development pipeline, with an anticipated cash runway through 2024. Immediately following the closing of the merger and the closing of the private placement, the shares issued in the private placement are anticipated to represent approximately 9% of the common stock of CohBar on a pro forma basis (assuming the exercise of all in-the-money warrants and options then outstanding).
Additionally, pre-merger CohBar stockholders and certain warrant holders of record will receive a contingent value right (CVR). Holders of the CVR will be entitled to receive certain payments from proceeds received by CohBar, if any, related to the disposition of CohBar’s legacy mitochondrial assets for a period of three years following the closing of the proposed merger.
The merger agreement has been approved by the boards of directors of both companies and is subject to stockholder approval of both companies and other customary closing conditions. The proposed merger is expected to close in the third quarter of 2023.
Following the merger, the combined company will be headquartered in Tampa, Florida, and the executive officers are expected to be James Bianco, MD as Chief Executive Officer, and Dan Dearborn, CPA as Chief Financial Officer. The merger agreement provides that the board of directors of the combined company will be composed of seven members, with five members initially designated by Morphogenesis and two members initially designated by CohBar.
Ladenburg Thalmann & Co., Inc. is acting as the exclusive financial advisor and Gibson, Dunn & Crutcher LLP is acting as legal counsel to CohBar. H.C. Wainwright & Co. is acting as the exclusive financial advisor and Foley & Lardner LLP is acting as legal counsel to Morphogenesis.
Conference Call & Webcast Details
The companies plan to hold a joint conference call and webcast today, May 23, 2023 at 8:30 AM ET to discuss the Merger details.
Interested participants and investors may access the conference call and webcast via the Investors section of the CohBar website at www.cohbar.com. A webcast replay will be available following the live event and will be accessible for 90 days.
About CohBar
CohBar (NASDAQ: CWBR) is a clinical-stage biotechnology company leveraging the power of the mitochondria and the peptides encoded in its genome to develop potential breakthrough therapeutics targeting chronic and age-related diseases with limited to no treatment options.
For additional company information, please visit www.cohbar.com and engage with us on LinkedIn.
About Morphogenesis, Inc.
Morphogenesis is a Phase 2/3 clinical-stage biotechnology company developing novel personalized cancer vaccines and tumor microenvironment modulators to overcome resistance to current immunotherapies. The company’s lead personalized cancer vaccine candidate, IFx-Hu2.0, is designed to prime the activation of the immune system to target and attack tumor cells by making them look like bacteria. Through an intratumoral injection of a gene coding for emm55, an immunogenic bacterial protein that is then expressed on the surface of tumor cells, the immune system is activated, providing a potent, multivalent systemic response against all neoantigens in a patient’s tumor. Morphogenesis is preparing to initiate a single Phase 2/3 registration trial as an adjunct to Keytruda® (pembrolizumab) in first line treatment for metastatic Merkel Cell Carcinoma (MCC). The company’s follow-
