Meet First Wave BioPharma: Exclusive interview with CEO James Sapirstein

In an exclusive interview with The Fly, First Wave BioPharma (FWBI) CEO James Sapirstein talked about the company, proprietary technologies, upcoming milestones, valuation, and much more.

PROPRIETARY TECHNOLOGIES: First Wave BioPharma is a clinical stage biopharmaceutical company specializing in the development of targeted, orally delivered therapies for gastrointestinal, or GI, diseases. The company is currently advancing a therapeutic development pipeline populated with multiple clinical stage programs built around its three proprietary technologies – latiglutenase, a potentially first-in-class oral biotherapeutic designed to aid gluten digestion and potentially reduce symptoms of celiac disease; capeserod, a selective 5-HT4 receptor partial agonist being developed for gastroparesis; and adrulipase, a recombinant lipase designed to enable the digestion of fats and other nutrients in patients with exocrine pancreatic insufficiency.

“We just acquired latiglutenase from ImmunogenX; we just merged the company a couple of weeks ago,” First Wave’s CEO explained to The Fly. “We’ve got a lot of work to do. First, we have to integrate the company. Second, we have to improve our manufacturing processes before we can get into Phase 3. We expect to be in Phase 3 in the first quarter of next year. You have to build up enough supply not only for Phase 3 but for commercial.”

“We acquired the second product, which is capeserod, from Sanofi (SNY), and we are going to file what’s called an IND next year. This drug has been around for a very long time. And in essence, it was studied for Alzheimer’s disease by Sanofi. They ran it through an AI process and realized it has gastroenterology applications. We’re looking at studying it in gastroparesis. Gastroparesis has become very popular as a side effect because people are taking Ozempic and Wegovy — all these GLP ones, and one of the fastest growing side effects of these drugs is something called gastroparesis, which slows down motility. It slows down the GI tract from working, and it actually interferes with the absorption of nutrients and fats,” the executive added.

“The third drug, which is adrulipase, used to be our flagship product. We are right now on the stage of examining all our data and then putting a report together for the FDA to see if they want us to continue in phase two or they let us go to phase three.”

IMMUNOGENX MERGER: First Wave has recently completed its business combination with ImmunogenX. Discussing how the deal has been received by the Street, Sapirstein told The Fly that, “interestingly enough, our stock price didn’t really react to the merger. This drug is for celiac disease. And there really isn’t anything on the market for celiac disease. We would be the first one to market. We really thought the stock price was going to really jump. Think about all the people with celiac disease… You have about over 6 million people who are afflicted just in Western Europe and the United States. But more importantly, 40% of all celiac patients are not properly diagnosed. So, the number is much bigger than that,” First Wave’s CEO said. “For us to it’s a big deal. We’re going to go into Phase 3, and we already have a strategic partner — I just can’t mention the name of the company, but it’s a large pharma company.”

UNDERVALUED: “(The Street is) absolutely missing (what the company is doing). We have four mid-stage developmental programs. You can go and look at some other private companies; their market capitalization is $2M-$3M and they don’t even have anything in the clinic. The chances that they’re going to get anything approved is very, very slim. Many products don’t even make it past Phase 2 let alone Phase 3. We achieved proof-of-concept in four of our products. So, we’re confident that we’ll get approval for one or two, maybe even three moving forward. I think the company’s way undervalued,” Sapirstein told The Fly. “Maybe they assumed we don’t have enough capital to do the trials and that’s why it’s a “wait and see” (story). But I’m in the process of raising that capital,” the executive added.

UPCOMING MILESTONES: Discussing upcoming milestones for First Wave, the CEO highlighted the capital raise, which “should bring the share price up,” and the potential announcement of a strategic partner. “When and if we announce the strategic partner – once they give us permission to, the stock should see a major boost.”

“Meet the Company” is The Fly’s recurring series of exclusive short interviews with Executive Officers to offer a deeper look inside the company.