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: Dane Leone - Raymond James Financial, Inc. - Analyst
: Excellent. Maybe for actually some of the people newer to the story, you could actually just give us the background in terms of how the platform
was developed. Obviously you have a specialty in muscle-directed drug candidates. What are some of the underlying tenets of your actual
foundational science that's allowed you to create these differentiated approaches to treating cardiac and skeletal muscle disorders?
Question: Dane Leone - Raymond James Financial, Inc. - Analyst
: Excellent. So, Robert, you took us over some of the near-term focus from the pipeline. Maybe focusing on Omecamtiv, you mentioned you've
already had a positive Phase III study. Now you're actually potentially even moving towards being a commercial organization. Can you take us
through the next steps and timeline for working towards -- into a regulatory filing?
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JUNE 21, 2021 / 6:00PM, CYTK.OQ - Cytokinetics Inc at Raymond James Human Health Innovation Conference
(Virtual)
Question: Dane Leone - Raymond James Financial, Inc. - Analyst
: And that bridges into a great topic of conversation. When we discuss Omecamtiv with the cardiology community, doctors obviously would love
to have access to the drug, be able to prescribe it. What, in your discussions with the FDA, and maybe discussing potential label, do you think are
going to be the key points that you need to help get access through the payers for these cardiologists?
For example, vericiquat is being launched. Most docs that we talk to would definitely go for Omecamtiv before vericiquat to address these patients
that are on maximum guideline-directed therapy but still unstable. What do you think, when you boil down the points, do you guys really want
on that label to help differentiate the drug and make sure that there's not going to be issues from payers getting access to patients?
Question: Dane Leone - Raymond James Financial, Inc. - Analyst
: Into that point, does your team, through their market research, have an idea of those larger cardiology care centers that you had focused initially
on and the percentage of those patients being treated there that are still really reduced ejection fraction, call it, below 28%, but maxed out on
GDMT? Do you have an idea, a ballpark of what the addressable market is when you -- if you get the label you want that would really be able to
get access to those patients?
Question: Dane Leone - Raymond James Financial, Inc. - Analyst
: Excellent. I do want to spend some time on CK-274. It's your next clinical program in cardiology. What's interesting about this program is it actually
is following another program that's awaiting FDA approval, mavacamten for obstructive hypertrophic cardiomyopathy. And that's now -- the
program is owned by Bristol via acquisition of MyoKardia.
In this case, your team was actually involved in the discovery work of mavacamten and then has developed CK-274 beyond that. What is your
team's view in terms of learnings from actually doing the discovery work around mavacamten and clinical development? And then what you've
learned and applied that to the development of CK-274?
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JUNE 21, 2021 / 6:00PM, CYTK.OQ - Cytokinetics Inc at Raymond James Human Health Innovation Conference
(Virtual)
Question: Dane Leone - Raymond James Financial, Inc. - Analyst
: Great bridge to just talking about the upcoming topline readout of the REDWOOD-HCM study of CK-274. Could your team maybe discuss expectations
for what you think would be included within the topline release and what data your team thinks to be more appropriate to say for a medical
conference later in the year?
Question: Dane Leone - Raymond James Financial, Inc. - Analyst
: And when you think about the design of CK-274 relative to mavacamten, what do you -- what (inaudible) CK-274 to the side. When you're thinking
about the clinical utilization of mavacamten and feedback from investigators on those studies that have had direct clinical experience, whether
they were blinded at the time, what do you think are some areas of improvement that would be pertinent as you evaluate CK-274 respectively to
mavacamten?
Question: Dane Leone - Raymond James Financial, Inc. - Analyst
: Great. I want to touch on partnering and collaboration. Obviously, you had a big collaboration and partnership agreement with Amgen on Omecamtiv
that's concluded and you're getting the asset back. What are some of the lessons learned about that collaboration, the ability of your team to
manage asset development the way you want to? And how would that influence future collaboration and partnership agreements that you may
sign either with Omecamtiv or potentially with CK-274?
Question: Dane Leone - Raymond James Financial, Inc. - Analyst
: Excellent. And in the minute remaining, I did want to just get an update from you on your skeletal muscle efforts and maybe just some of the next
steps that we should think about with the Reldesemtiv program.
Question: Dane Leone - Raymond James Financial, Inc. - Analyst
: Excellent. Well, thank you very much, Robert. Thank you very much, Fady, for having this discussion with me today. Very informative, I think helpful.
We all look forward to the upcoming results of the REDWOOD study. I'm sure that will be great to see. And then more updates around Omecamtiv
as the year progresses.
So, obviously, if anyone in the audience needs to contact Robert or Fady, if you know Diane, you can reach out to Diane. Otherwise, I'd be happy
to help as well. So, thank you guys very much.
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