Fulcrum Therapeutics, Inc. (NASDAQ:FULC) Q3 2023 Earnings Call Transcript

The Redox 4 study enrolled only type 1s and so even though we’re enrolling some type 2s in the REACH study, we powered the study on only the type 1. So the study was powered on an expectation of 210 type 1 patients in the reach study and that gave us a power of 93% or 94% using the magnitude of change and the standard deviation from Redox 4. As it turns out, when we cut off screening for the REACH study based on what we thought the screen fail rate was going to be in order to reach those 230 patients, the screen fail rate dropped down and we ended up enrolling a number more patients. And so at the end of the day, the total enrolment was 260 instead of 230 and of that 260, there were 18 FSHD type 2s. So we now have 242 FSHD 1s. So 242 versus the original powering around 210.

So that bumps the power up into over 95% using the same assumptions from Redox 4. So that was an inadvertent over-enrolment. That wasn’t our intention, but was a reflection of the enthusiasm at the sites and the fact that the sites had gotten better at screening the patients until the screen fail rate dropped down and so that’s where we stand based on our actual enrolment now in REACH.

Operator: Ladies and gentlemen, this concludes the question-and-answer portion of the call. I would now like to turn the call back over to Fulcrum’s CEO, Alex, for closing remarks.

Alex Sapir: Thanks, Tawanda . So just to quickly wrap up, we remain, as we always have, deeply committed to treating the root cause of genetically defined rare diseases and bringing these transformative therapies to patients. Before we conclude today’s call, as I always like to do, I’d just like to extend my sincere appreciation and gratitude to my fellow Fulcrum teammates, to the physicians we work with to advance our clinical trials, and finally and most importantly, to the patients who participate in our clinical trials, as well as their families. Without them, we would not be able to achieve our goals as a company. Thanks again, everyone who joined the call this morning. Please stay safe and healthy.

Operator: Ladies and gentlemen, this concludes today’s conference call. Thank you for your participation. You may now disconnect.