The following is excerpted from the question-and-answer section of the transcript.
(Questions from industry analysts are provided in full, but answers are omitted - download the transcript to see the full question-and-answer session)
Question: Paul Choi - Cytokinetics, Inc. - Analyst
: What we'll do is I'll let Robert kick it off with a few introductory remarks and then we'll go into Q&A. If there are any questions along the way from
the audience, please feel free to raise your hand and we'll get a mike to you. Alternatively, please feel free to shoot me an e-mail at paul.k.choi.com.
I'm happy to read your question anonymously as well, too.
So with that, Robert, I'll turn it over to you.
Question: Paul Choi - Cytokinetics, Inc. - Analyst
: Okay. Thank you, Robert. Maybe starting with some of the clinical side of things. You recently presented detailed to acquire HCM data at the ESC
Heart Failure meeting in Lisbon. So in your view. I guess what are the key highlights of the data and sort of what stands out most in your mind?
Question: Paul Choi - Cytokinetics, Inc. - Analyst
: I guess you touched a little bit on physician reaction. But I guess as you've heard and listened to physician feedback, I guess what do doctors say
in terms of what they see as the most important differences versus personal scams IOs and you know, are these differences significant in their view
in terms of the physician
Question: Paul Choi - Cytokinetics, Inc. - Analyst
: And I think some of the KOL feedback on the panel that you guys hosted was certainly interesting in terms of views on PDPK and PD excursions or
lack thereof rather. And just to your point on dose and dose interruptions, not nothing being a factor or dose titrations.
Question: Paul Choi - Cytokinetics, Inc. - Analyst
: Now that you've presented top-line data. I want to talk a little bit about regulatory next steps. You've talked about two key regulatory interactions
in the front half of this year. The next key one being a potential Type B meeting with the FDA. What can you maybe share on the Type B meeting
to date here? And just what what you would probably want to think about or investors should think about in terms of what Andrew mentioned in
terms of the shape of it.
Question: Paul Choi - Cytokinetics, Inc. - Analyst
: Okay, great. I'm outside of the NDA. You mentioned earlier, you do have a robust clinical development program for Epic Hampton, which includes
the Maple HCM head to head study and the Acacia study in non-obstructive.
And can you maybe provide us a quick update on where Maple stands in terms of progress in enrollment and then we can touch on the Acacia as
well for the non-obstructive opportunity.
Question: Paul Choi - Cytokinetics, Inc. - Analyst
: Also, could you maybe briefly remind us just in terms of the Acacia study, this is a slightly different population, as you mentioned, in terms of
non-obstructive, what are sort of the relevant clinical measures here for this population versus exercise capacity for the obstructive population
here?
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JUNE 10, 2024 / 3:20PM, CYTK.OQ - Cytokinetics Inc at Goldman Sachs Global Healthcare Conference
Question: Paul Choi - Cytokinetics, Inc. - Analyst
: Great. Maybe to wrap it up here. In terms of the regulatory path, you obviously have now top line and presented SEQUOIA. You also have the
ongoing forced OLE data with those two datasets compromise the bulk of your regulatory filing, both in terms of the efficacy and safety data set,
are there any other sort of ongoing obligations or plan many studies as part of your part of your NDA?
Question: Paul Choi - Cytokinetics, Inc. - Analyst
: So these are just the standard heat humidity, light and bag testing for for stability batches.
Question: Paul Choi - Cytokinetics, Inc. - Analyst
: And speaking of Asia. Robert, maybe you can update us on terms of your on your business development efforts here to find a partner for ex China
and just sort of what are the status of these discussions? I think that's been of investor interest recently.
Question: Paul Choi - Cytokinetics, Inc. - Analyst
: Okay. I want to give Andrew, maybe a moment to talk a little bit about commercial prep in terms of where you are in terms of key milestones and
building out the sales infrastructure and commercial infrastructure, MSLs and so forth and also just sort of the to market plan. I think those of us
who follow Bristol have probably seen a little bit of DTCI here and there in terms of TV ads and so forth. And so could you maybe just speak to those
two things.
Question: Paul Choi - Cytokinetics, Inc. - Analyst
: Okay. I will turn to maybe other areas of the pipeline and starting with the CK. five, eight, six and later this year, you'll present sort of Phase one
SAD and MAD data. Are you in the investigational drug for here? So I guess how should we think about what what good PK/PD data looks like from
your SAD/MAD MAD studies here. And so how do you think about potential other measures such as fractional shortening and or diastolic risk
response here?
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JUNE 10, 2024 / 3:20PM, CYTK.OQ - Cytokinetics Inc at Goldman Sachs Global Healthcare Conference
Question: Paul Choi - Cytokinetics, Inc. - Analyst
: Okay, great. One of the other area of the pipeline I want to touch is your decision or recent statements on Mackenzie mecarbil. You've indicated
that you want to do another clinical trial here, which is a bit of a reversal from your prior stance.
And so I guess the question is what insights have you gained since you presented the GALACTIC HF. results and how we apply these in a new study
here?
Question: Paul Choi - Cytokinetics, Inc. - Analyst
: I have an e-mail question from the audience regarding pipeline, not on any direct drug, but the question is on given obesity is seems to be the
most popular investment thematic here in health care currently. Do you guys have any sort of muscle program that potentially touches on some
of the issues that come up with obesity drugs such as GLP ones or anything like that.
Question: Paul Choi - Cytokinetics, Inc. - Analyst
: Trupanion program, very interest. We're coming up on time. So I wanted to maybe just address one question that also was in the investment
community.
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JUNE 10, 2024 / 3:20PM, CYTK.OQ - Cytokinetics Inc at Goldman Sachs Global Healthcare Conference
Just regarding your deal terms with Royalty Pharma, can you maybe just briefly summarize the terms of your recent financing for them and in terms
of what was sort of the impetus and genesis of the drugs? And just sort of what are sort of your various upside and downside scenarios here?
Question: Paul Choi - Cytokinetics, Inc. - Analyst
: Okay. We've come up on time here. So we'll have to end it on that note, and my thanks to Robert and Andrew for joining us, and we'll end the
session now.
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