First Wave BioPharma Inc FWBI is gearing up for a mighty move as they’ve inked a non-binding term sheet to snap up ImmunogenX in an all-stock transaction. Both companies are laser-focused on driving forward a pipeline tailored for tackling gastrointestinal (GI) issues.
Keeping the ship steady, James Sapirstein is set to continue as Chairman, President, and CEO of First Wave BioPharma, with Jack Syage, CEO, and co-founder of ImmunogenX, taking the helm as Chief Medical Officer.
This game-changing transaction is on the cards to wrap up within the first half of 2024. Although the exact financial details remain under wraps, the anticipation is high for a substantial infusion of funds from a global pharmaceutical heavyweight for commercial rights to latiglutenase in the U.S., along with pledges of financial support from several institutional investors for post-closing development.
“We’re revving up to expedite the regulatory, manufacturing, and clinical processes, setting the stage to kick-start pivotal Phase 3 clinical trials of latiglutenase by the latter half of 2024. This trajectory could potentially pave the way for latiglutenase’s entry into the multibillion-dollar celiac disease market by 2027,” expressed an optimistic James Sapirstein.
The star of the show, latiglutenase, is an orally administered blend of two minimally systemically absorbed gluten-specific recombinant proteases designed as an oral biotherapeutic for celiac disease.
Excitement is building as Phase 2a and 2b clinical trials have revealed latiglutenase’s potential to mitigate gluten-induced intestinal mucosal injury and alleviate the severity and frequency of symptoms in celiac patients.
Additionally, approval is hot on the heels as the FDA’s GI Division has given the nod for First Wave BioPharma’s Phase 3 clinical development plan for latiglutenase, with the green light expected to flash for the onset of the Phase 3 trials in the latter half of 2024.
Absolutely no stranger to making waves, in September, First Wave BioPharma lined up an agreement with Sanofi SA SNY to license Capeserod, a selective 5-HT4 receptor partial agonist, which First Wave will rebrand and develop for GI indications.
Not content to ride the same wave, First Wave BioPharma’s board threw their support behind a gutsy 1-for-20 reverse stock split, set in motion as of today.
Price Action: FWBI shares rounded off at $4.418 at Friday’s close.