First Wave BioPharma Completes Merger Deal With ImmunogenX Adding Phase 3-Ready Candidate For Celiac Disease

First Wave BioPharma Inc FWBI has acquired ImmunogenX in an all-stock transaction with the combined company focused on advancing a gastrointestinal (GI) pipeline.

First Wave BioPharma signed a non-binding term sheet in December to acquire ImmunogenX.

James Sapirstein will continue to serve as Chairman and CEO of First Wave BioPharma, with Dr. Jack Syage, previously the CEO and Co-Founder of ImmunogenX, assuming the role of President and Chief Operating Officer of First Wave BioPharma.

First Wave BioPharma intends to license the commercial rights to latiglutenase in the U.S. and Canada to a global pharmaceutical company. 

It will also seek to secure financing commitments from a syndicate of institutional healthcare investors in the second half of 2024 to fund the ongoing development of latiglutenase. 

“We expect to finalize these agreements prior to initiating preparatory work for the Phase 3 latiglutenase trials,” Sapirstein said.

Latiglutenase, an oral biotherapeutic composed of two gluten-specific recombinant proteases, has demonstrated effectiveness in reducing intestinal damage and alleviating symptoms of celiac disease in two Phase 2 trials involving approximately 200 patients. 

The Phase 3 clinical plan for latiglutenase has been reviewed by the GI Division of the FDA, and the trials are anticipated to begin in early 2025 compared to 2H of 2024 expected earlier. 

“Completion of the acquisition of ImmunogenX and the addition of latiglutenase to our clinical pipeline is a transformative event for First Wave BioPharma as it provides our company with a Phase 3-ready asset in a multibillion-dollar GI market – celiac disease – for which no approved pharmacologic treatment currently exists,” Sapirstein added. 

Upon closing the acquisition, the company issued 365,162 shares of its common stock to the shareholders of ImmunogenX, equal to 19.02% of its currently issued and outstanding common stock and 11,777.418 shares of its newly issued Series G Convertible Preferred Stock.

In December, First Wave BioPharma entered a non-binding term sheet to sell its Niclosamide program for treating inflammatory bowel diseases.

Price Action: FWBI shares closed at $6.53 on Wednesday.