First Wave BioPharma enters term sheet for combination with ImmunogenX

First Wave BioPharma announced that the company has signed a non-binding term sheet for a business combination with ImmunogenX, a clinical-stage biotherapeutics company developing Phase 3-ready latiglutenase, a targeted, oral biotherapeutic for celiac disease. Pursuant to the term sheet, First Wave BioPharma will acquire ImmunogenX in an all-stock transaction with the combined company focused on advancing a GI pipeline comprised of multiple late-stage clinical assets, including latiglutenase and capeserod, which First Wave BioPharma recently in-licensed from Sanofi. Following consummation of the transaction, First Wave BioPharma will continue to trade on Nasdaq under the ticker symbol “FWBI“. The transaction, which has been approved by the Boards of Directors of both companies, is subject to the negotiation and execution of definitive documentation, approval of the stockholders of both First Wave BioPharma and ImmunogenX and other customary closing conditions and is expected to close in the first half of 2024. Following the closing, James Sapirstein will continue to serve as Chairman and Chief Executive Officer of First Wave BioPharma with Jack Syage, Ph.D., CEO and Co-Founder of ImmunogenX, assuming the role of President and COO. Operational and financial leadership positions will be comprised of current First Wave BioPharma executives, while clinical, regulatory affairs, and scientific positions will be led by executives of ImmunogenX. First Wave BioPharma anticipates a significant non-dilutive financial investment from a strategic global pharmaceutical company for commercial rights to latiglutenase in the United States, in addition to financing commitments from several institutional investors to fund development, will be completed post-closing. Latiglutenase is an orally administered mixture of two minimally systemically absorbed gluten-specific recombinant proteases being developed as an oral biotherapeutic for celiac disease. In Phase 2a and 2b clinical trials, latiglutenase was shown to mitigate gluten-induced intestinal mucosal injury as well as reduce the severity and frequency of symptoms in celiac disease patients. The Phase 3 clinical development plan for latiglutenase has been reviewed by the GI Division of the U.S. Food and Drug Administration at the End of Phase 2 meeting with an agreed plan forward, with initiation of the Phase 3 trials expected in the second half of 2024.