Leading in tumultuous times: Moonlake’s Jorge Santos Da Silva on The BioCentury Show

Moonlake CEO discusses how he is preparing to build the next pipeline-in-a-product in I&I

As CEO of a biotech launched in 2021, Jorge Santos Da Silva has had his leadership mettle tested by a pandemic, rising interest rates, a bear market, and a tumultuous U.S. policy environment — all while building the case for Moonlake’s lead program to become a top therapy for hidradenitis suppurativa and, eventually, a “pipeline-in-a-product.”

The key for Santos Da Silva as founder and CEO of  Moonlake Immunotherapeutics AG (NASDAQ:MLTX) is to dial down the noise and focus on the key choices in front of him.

“Moonlake has always existed in times of turmoil,” Santos Da Silva told The BioCentury Show, citing the recent M&A drought, high interest rates and political turmoil. “Understanding the situation from a cool perspective, being able to explain that to your people first, and then try to explain that to the Street and place the company in the right moment so that you have all the game in front of you,” has been his biggest learning.

His perspective extends to fundraising — “think more broadly than the equity markets” — and to the recent turbulence at FDA, which is “still full of very, very, very skilled very, very knowledgeable people,” he says. “There’s a lot of noise right now. I always find it a little bit interesting that there’s so much noise when so very little is actually changing in reality.”

Moonlake’s sonelokimab (SLK), a Nanobody against IL-17A and IL-17F, is expected to enter Phase III testing this year for hidradenitis suppurativa (HS), a debilitating and painful syndrome that is believed to be caused by inflammation that blocks hair follicles in sensitive areas of the body. The under-served indication seemed to emerge from out of nowhere in recent years, blooming into a competitive space with double-digit compounds in late-stage development and a market that the biotech expects to grow to $10-$15 billion by 2030. SLK, one of the most advanced multispecifics in the clinic for inflammation and immunology diseases, has generated positive Phase II data that has differentiated it from mAbs in the indication.

One of the challenges facing the company, Santos Da Silva said, is narrowing down the indications it can pursue from the 20 to 25 it believes the compound could treat to a handful that will help establish the therapy as a pipeline-in-a-product. The CEO discusses how he and his team think through choices from which indications to pursue, to how to decide on where to build out its manufacturing sites.

“I think this is really about making choices, right? Even in a situation where we had infinite money, then you don’t have infinite people. They don’t have infinite talent. And then you don’t have your infinite management capacity to make sure the ship stays straight, going fast to the objective, so you always have to make choices,” he said.