Cytokinetics Inc at Needham Healthcare Conference (Virtual) Transcript

The following is excerpted from the question-and-answer section of the transcript.

Question: Serge Belanger - Needham & Company - Analyst : Sure. So maybe let's step back and talk about the setbacks. First, omecamtiv, you got a CRL. I think you've talked about exploring additional steps, meeting with the FDA. So maybe just a quick overview on -- if you can salvage any value via partnerships from omecamtiv.

Question: Serge Belanger - Needham & Company - Analyst : Great. So moving on to aficamten, now, the main focus of the company. Maybe just talk about the overall clinical development program. You recorded Phase 2 data, I think, over, I think it was 2021. We've seen additional data from the REDWOOD trial since then, but maybe let's start there and give us an overview of what excites you about aficamten in HCM.

Question: Serge Belanger - Needham & Company - Analyst : Got it.

Question: Serge Belanger - Needham & Company - Analyst : Yeah. And obviously, with another product on the market addressing the same indication, a lot of people are comparing aficamten to mavacamten. Without going into a direct comparison, maybe just highlight, based on the REDWOOD data, what you think are some potential differentiation and advantages that you can see with aficamten.

Question: Serge Belanger - Needham & Company - Analyst : And you've laid out a pretty extensive Phase 3 development program for aficamten. The SEQUOIA trial is underway, and two additional trials will get underway second half that you'll provide us more details, I guess, later on. But let's start with the SEQUOIA trial, maybe just an overview of the design and the primary endpoint.

Question: Serge Belanger - Needham & Company - Analyst : So on the primary endpoint, what would be a successful outcome in terms of differences versus placebo?

Question: Serge Belanger - Needham & Company - Analyst : And did you look at the pVO2 endpoint in the REDWOOD study as a secondary? REFINITIV STREETEVENTS | www.refinitiv.com | Contact Us consent of Refinitiv. 'Refinitiv' and the Refinitiv logo are registered trademarks of Refinitiv and its affiliated companies. APRIL 17, 2023 / 2:00PM, CYTK.OQ - Cytokinetics Inc at Needham Healthcare Conference (Virtual)

Question: Serge Belanger - Needham & Company - Analyst : Okay. I think in the last update, you mentioned that the study was two-thirds enrolled. I think that was back in early March. So it's still on target to reach full enrollment sometime in the second quarter and read out by year end. Is that (multiple speakers)

Question: Serge Belanger - Needham & Company - Analyst : Okay. Fantastic. You've talked about two other studies. So the MAPLE study, another obstructive HCM trial, this one against a beta blocker. Maybe just talk about the design and what the goal of the study is.

Question: Serge Belanger - Needham & Company - Analyst : Got it. And primary endpoint here is similar to SEQUOIA?

Question: Serge Belanger - Needham & Company - Analyst : Okay. And you'll be looking for superiority over metoprolol? REFINITIV STREETEVENTS | www.refinitiv.com | Contact Us consent of Refinitiv. 'Refinitiv' and the Refinitiv logo are registered trademarks of Refinitiv and its affiliated companies. APRIL 17, 2023 / 2:00PM, CYTK.OQ - Cytokinetics Inc at Needham Healthcare Conference (Virtual)

Question: Serge Belanger - Needham & Company - Analyst : Okay. And in terms of patient numbers and trial sizing, what kind of numbers are we looking at here?

Question: Serge Belanger - Needham & Company - Analyst : Okay. And this will get underway once SEQUOIA is completed or once it's completed enrollment, right?

Question: Serge Belanger - Needham & Company - Analyst : Okay. So regulatory strategy is to file an initial NDA based on SEQUOIA and then eventually file a supplement NDA with the MAPLE study?

Question: Serge Belanger - Needham & Company - Analyst : Okay. And then the third Phase 3 trial, still unnamed as far as I remember, in non-obstructive HCM, tell us how you designed that trial, what kind of endpoints you'll be looking at, how different is it from obstructive HCM.

Question: Serge Belanger - Needham & Company - Analyst : Okay. So trial will get underway potentially in the second half of the year?

Question: Serge Belanger - Needham & Company - Analyst : Okay. So with the two Phase 3 trials in obstructive HCM, tell us a little bit of what kind of label you're targeting. And I know, again, we're going to compare it to mavacamten, but they have a REMS program. What are your expectations around a REMS? Could it be a lesser REMS or no REMS?

Question: Serge Belanger - Needham & Company - Analyst : Let's talk about the market opportunity for aficamten in both obstructive and non-obstructive. I think everybody thinks this is a multi-billion dollar market opportunity. Just curious if your outlook for this market has changed with the mavacamten launch. Is it the same, bigger, smaller?

Question: Serge Belanger - Needham & Company - Analyst : Got it. So the patient numbers that have been talked about in the past are still very much intact. It's just, I guess, a question of execution and education in order to realize the market potentials (multiple speakers)

Question: Serge Belanger - Needham & Company - Analyst : Okay. And maybe just talk or -- you're going to be reporting Phase 3 data late this year, and then obviously it's filing an NDA. So maybe just some thoughts on commercialization of aficamten, what that could potentially look like.

Question: Serge Belanger - Needham & Company - Analyst : Okay. So just to wrap up, aficamten, we'll see additional data from REDWOOD in May.

Question: Serge Belanger - Needham & Company - Analyst : Okay. And just wanted to touch on some earlier stage programs that are ongoing. So CK-136, the troponin activator, maybe just a quick overview at where you are in development.

Question: Serge Belanger - Needham & Company - Analyst : Okay. I think recently unveiled 586, a new cardiac myosin inhibitor. How different is this from aficamten?

Question: Serge Belanger - Needham & Company - Analyst : And just to finish off, maybe just a financial overview. I know we'll probably get an update on OpEx guidance next month at -- during the earnings call. But based on the most recent numbers that you reported, what is the runway and OpEx for 2023?

Question: Serge Belanger - Needham & Company - Analyst : Okay. I guess just a last question. Given the recent setbacks, curious if that changes your outlook and strategy for the company in terms of partnerships and collaborations, either development or commercialization.

Question: Serge Belanger - Needham & Company - Analyst : Okay. Well, I know -- I want to thank both of you for spending time with us this morning. It was a great overview, and look forward to the next updates on aficamten.