Latest / Vanguards of Healthcare by Bloomberg Intelligence / Precision Cardiology With Cytokinetics

Transcript

Precision Cardiology With Cytokinetics · Vanguards of Healthcare by Bloomberg Intelligence

0:19
Speaker 1: Welcome everyone to another episode of the Vanguards of Healthcare podcast.
0:23
Speaker 1: I'm your host Andrew Galler, one of the biopharmaceutical analysts
0:26
Speaker 1: in Bloomberg Intelligence. Bloomberg Intelligence is Bloomberg's corporate research arm,
0:31
Speaker 1: encompassing over five hundred analysts worldwide. I'm pleased to be
0:35
Speaker 1: joined today by Robert Blum, President CEO of Cyberkinetics. Robert,
0:39
Speaker 1: thanks for joining us today. Thank you, Andrew, thanks for
0:42
Speaker 1: the invitation. So maybe just to kick it off, do
0:45
Speaker 1: you want to talk give everyone a brief overview of
0:47
Speaker 1: Cyberkinetics at the company and maybe the thirty year journey
0:50
Speaker 1: you've had from founding to the recent approval of your
0:52
Speaker 1: first FDA approved drug. My corzo very pleased.
0:56
Speaker 2: To do that, and ours is somewhat of an un
1:00
Speaker 2: common story, and to your point, it goes back some time,
1:05
Speaker 2: not quite thirty years, but certainly a long time. This
1:09
Speaker 2: is our twenty eighth year since we began operations as
1:14
Speaker 2: a company, and I was privileged to launch this company
1:20
Speaker 2: alongside of scientific founders and other scientists who were experts
1:25
Speaker 2: in an area of biology that we committed to mind
1:30
Speaker 2: for a new pharmacology. And we like to joke. Nobody's
1:34
Speaker 2: ever going to accuse us of being an overnight success.
1:37
Speaker 2: But we have been working very diligently and with focus
1:43
Speaker 2: to build an unusual type of company, one very disciplined
1:47
Speaker 2: to this biology and that is the cytoskeleton and the
1:52
Speaker 2: mechanics of cell behavior, and a business that's rooted in
1:58
Speaker 2: a different approach to how we aim our science, where
2:03
Speaker 2: we access and how we deploy capital, and how the
2:08
Speaker 2: R and D and commercial ambitions of the company synchronized
2:14
Speaker 2: to align to where we are today. Cytokinetics has pioneered
2:19
Speaker 2: and leads in this area of muscle biology, specifically towards
2:25
Speaker 2: a pipeline of new medicines in specialty cardiology, and that
2:32
Speaker 2: culminated in an FDA approval of our first medicine in December,
2:38
Speaker 2: coincident with approval in China and also a positive CHMP
2:45
Speaker 2: opinion all in December, and as was enabling of us
2:51
Speaker 2: to turn the page onto our business as we now
2:55
Speaker 2: go to market. In fact, this week we're going live
3:01
Speaker 2: with a REMS program and enabling physicians to be certified
3:07
Speaker 2: for patients to be getting our first medicine, a drug
3:12
Speaker 2: called my Corzo that's now approved for the treatment of
3:17
Speaker 2: obstructive HCM in the United States.
3:20
Speaker 1: Absolutely, and maybe before you getend too nitty gritty of
3:23
Speaker 1: that launch and your product profiles and everything else, maybe
3:26
Speaker 1: just a high level of philosophical question on cardiology in general.
3:29
Speaker 1: I feels like over maybe the last twenty to twenty
3:31
Speaker 1: five years, it's definitely shifted to more of a specialty
3:34
Speaker 1: and precision driven fiod to medicine, whereas before that there's
3:38
Speaker 1: kind of a one size fits all approach where someone
3:40
Speaker 1: we go in with cardiac issues, they'll get ASR beta blockers,
3:43
Speaker 1: diuretics and so on and so forth. Do you agree
3:46
Speaker 1: with that statement?
3:47
Speaker 2: Yes and no. I agree that there's been a shift
3:50
Speaker 2: in the biopharma sentiments towards specialty cardiology. I'd like to
3:55
Speaker 2: think Cutokinetics is leading the way there, but also other
3:59
Speaker 2: companies like a Nylom and Bridge Bio doing quite substantial
4:05
Speaker 2: things as they innovate. Also, but I'll also tell you
4:09
Speaker 2: that this company follows behind another company I was involved
4:13
Speaker 2: with in the nineteen nineties that did a similar thing,
4:17
Speaker 2: a company called Core Therapeutics that developed a new antithrombotic
4:23
Speaker 2: with a similar business model, And there we went head
4:28
Speaker 2: to head as was enabling of a best in class drug,
4:34
Speaker 2: rooted similarly in biopharmaceutical innovation towards a specialty model. And
4:40
Speaker 2: I'd say there are episodic and intermittent examples of this,
4:47
Speaker 2: but for which they are farther and fewer in between
4:51
Speaker 2: when you look in the rear view mirror, and I
4:53
Speaker 2: do think with advances in genetic medicine and specialty cardiology,
4:59
Speaker 2: Cytokinetics is one of now several companies that are aiming
5:03
Speaker 2: towards the same objective. It requires advances not only in biology,
5:08
Speaker 2: but also how we think about accessing and deploying capital
5:12
Speaker 2: and building sales and marketing infrastructure that enable a higher
5:17
Speaker 2: return on investment and shareholder equity, as I think is
5:21
Speaker 2: becoming more common in cardiology. Cardiology for decades has represented
5:28
Speaker 2: the leading cause of death in the United States, heart
5:32
Speaker 2: failure the leading reason why patients in the United States
5:36
Speaker 2: are hospitalized, and over the eighties and nineties and into
5:41
Speaker 2: the two thousands, we've seen dents in how we can
5:46
Speaker 2: treat certain acute cardiovascular conditions, like in the area from
5:52
Speaker 2: politics and from boss associated with heart attacks and stroke.
5:57
Speaker 2: But now we're seeing how there are new medicines that
6:01
Speaker 2: act directly on the heart itself and less on downstream
6:08
Speaker 2: consequences of heart disease. And that's affording a new way
6:12
Speaker 2: of thinking about specialty cardiology, as you're pointing out, and
6:16
Speaker 2: cytokinetics is anchored in that kind of science, as I'm
6:21
Speaker 2: sure we'll talk about today.
6:23
Speaker 1: So I guess maybe some of your points you think
6:26
Speaker 1: it's moving to tardeing the core underlying pathology of the
6:30
Speaker 1: cardiovascular disease rather than the downstream effects.
6:33
Speaker 2: Yes, exactly. So if you look at the drugs we
6:36
Speaker 2: used in cardiology in the eighties, the nineties and subsequent,
6:40
Speaker 2: many of them were acting on the vasculature, many of
6:45
Speaker 2: them were operating on consequences of impaired cardiac function. Now
6:53
Speaker 2: we understand a lot more about the etiology the pathophysiology
6:57
Speaker 2: of cardiac disease, and we can trigued it at its
7:00
Speaker 2: root cause, which is cardiac muscle. And that's where I
7:04
Speaker 2: think putokinetics has been a pioneer and a leader as
7:08
Speaker 2: we understand, hopefully better than anyone else, what's underlying cardiac
7:14
Speaker 2: dysfunction and impairment. Your heart is fundamentally a pump. It's
7:19
Speaker 2: made up of cardiac myocytes in cardiac muscle and cutokinetics
7:24
Speaker 2: has been focused to ways of addressing either hyper contractility
7:30
Speaker 2: or hypo contractility. Now for many years, and as we
7:35
Speaker 2: have our first FDA approval and with investigational medicines behind it,
7:41
Speaker 2: we hope to be defining of how that innovation can
7:44
Speaker 2: benefit patients.
7:46
Speaker 1: So a you know, for decades of the scientific community
7:49
Speaker 1: has kind of changed it sentiment towards how they treat
7:51
Speaker 1: cardiovascular disease. Let's have about the clinical practice side. How has
7:55
Speaker 1: what's been the impetus to change there?
8:00
Speaker 2: Well, I do think it remains an unsolved problem as
8:04
Speaker 2: to how to do a better job to address not
8:08
Speaker 2: only cardiac comorbidities. We still confront a situation where amongst
8:17
Speaker 2: medicare patients, heart disease is the number one driver of clinical, societal,
8:26
Speaker 2: and economic burden. But we also have a situation where
8:32
Speaker 2: the population is aging longer and living longer with cardiac conditions.
8:38
Speaker 2: So it's incumbent upon us to understand more how to
8:43
Speaker 2: make a dent in the universe, and the clinical communities
8:46
Speaker 2: are understanding this at the same time that scientific innovation
8:52
Speaker 2: is driving new opportunities, and I do believe that where
9:00
Speaker 2: we've made as an industry, huge tremendous progress in other
9:06
Speaker 2: conditions that's still largely elusive in cardiac medicine, and I
9:13
Speaker 2: think a perfect storm is brewing as companies like Sautokinetics
9:18
Speaker 2: and others that I previously mentioned are now coming onto
9:23
Speaker 2: the scene. Where we still have major gaps is outside
9:29
Speaker 2: of academic centers and tertiary care centers. There are huge inequities,
9:35
Speaker 2: especially in rural communities, in terms of quality and access
9:40
Speaker 2: to care. And that's where I think we need to
9:43
Speaker 2: be thinking not only about genetic code, but zip code
9:48
Speaker 2: in terms of how we ensure equitable access to these
9:51
Speaker 2: new medicines as well.
9:54
Speaker 1: Absolutely, maybe if we change gears a bit to talk
9:56
Speaker 1: about the micors I launch, So give us a general
10:00
Speaker 1: sense of launch readiness. Activities you've undertaken ahead of the approval,
10:04
Speaker 1: whether that's talking physician to building awareness or hiring salesforce,
10:09
Speaker 1: just anything that you've been working on.
10:12
Speaker 2: Yeah. So, may I first say that this is not
10:16
Speaker 2: something that you do abruptly, but it's been part of
10:21
Speaker 2: our planning from day one, and I don't say that
10:25
Speaker 2: with hyperbole. I mean it. We've always identified programs we
10:30
Speaker 2: should work on scientifically as ones that could be cohesive
10:35
Speaker 2: to a commercial rationale in addition to a therapeutic hypothesis,
10:40
Speaker 2: and where we could not only pioneer and lead, but
10:44
Speaker 2: hopefully dominate. So we've been building out our commercial infrastructure
10:49
Speaker 2: all along the way, global marketing, new product planning, market research,
10:55
Speaker 2: and positioning. I've been hallmarks of how we engage scientifically
10:59
Speaker 2: and in clinical research. And hence, with now an approved medicine,
11:06
Speaker 2: we are plug and play on things that have been
11:09
Speaker 2: in the planning stages for many, many years. We have
11:16
Speaker 2: focused to indications where even with our limited access to
11:20
Speaker 2: capital and with a limited sales and marketing infrastructure, we
11:24
Speaker 2: can build a physician, pharmacy and patient experience bespoke to
11:31
Speaker 2: this opportunity and our opportunity to lead. So now to
11:35
Speaker 2: answer your question, over the years, we have built sales
11:42
Speaker 2: territories configured with sales leaders and managers three four, five
11:48
Speaker 2: years ago, and a medical affairs team that's harnessing our
11:53
Speaker 2: science and as we go to market. Now we have
11:58
Speaker 2: dozens of published, peer reviewed manuscripts that provide support for
12:04
Speaker 2: what are newly hired sales representatives. We call them cardiology
12:10
Speaker 2: account specialists. Will be doing those cardiology account specialists were
12:16
Speaker 2: hired in twenty twenty five in two waves. They were
12:21
Speaker 2: placed into territories, they were trained so as to be
12:24
Speaker 2: compliant and ready for this moment, and they're partnered with
12:30
Speaker 2: scientists in their training, medical affairs colleagues in their execution,
12:36
Speaker 2: and we've built a seamless culture cohesive to all that
12:40
Speaker 2: we know about good science for the benefit of patience
12:44
Speaker 2: and medicine. The Cardiology account specialists have over twenty years
12:50
Speaker 2: on average of sales experience, over fourteen years on average
12:55
Speaker 2: of cardiology experience, over five years of President Awards experience,
13:02
Speaker 2: and now they're deployed in territories and this week as
13:07
Speaker 2: we go live with product in channel and REM's program
13:13
Speaker 2: in place, enabling of us to show up for customers
13:18
Speaker 2: in a way that we think will be distinguishing what
13:22
Speaker 2: we do. And it's not just about promotion, it's also
13:27
Speaker 2: about digital marketing. It's also about the patient hub experience
13:33
Speaker 2: bespoke to this opportunity as opposed to retrofitted from prior
13:39
Speaker 2: architecture and execution. It's about how we've been engaging with
13:44
Speaker 2: payers for several years to be enabling of them to
13:48
Speaker 2: understand what's coming soon and how they can be best
13:51
Speaker 2: prepared for a new medicine. So all these things have
13:55
Speaker 2: been going on for quite some time, not only in
13:58
Speaker 2: the United States, but also in Europe, where we will
14:01
Speaker 2: be going to market in the second quarter based on
14:05
Speaker 2: our expected hopeful approval in the first quarter.
14:11
Speaker 1: I guess that's on your last point. We totally don't
14:14
Speaker 1: see smitcap biotechs going to market alone in Europe, So
14:18
Speaker 1: what's driving the decision to do that rather than seek
14:20
Speaker 1: out a partner.
14:22
Speaker 2: Yeah, I think your observation is an accurate one. And
14:25
Speaker 2: we've been good students of those companies that have gone
14:28
Speaker 2: to Europe as well as those who went to Europe
14:31
Speaker 2: and perhaps they failed, and there are plenty of examples
14:37
Speaker 2: of both. And where we see are fit for purpose
14:41
Speaker 2: strategy is in a way that's staged, so that we
14:46
Speaker 2: deploy resources in a hub and spoke model with headquarters
14:50
Speaker 2: staff primarily readying market access, medical affairs, legal finance, and otherwise,
14:59
Speaker 2: but only deploying in countries where we have visibility to
15:05
Speaker 2: proximal reimbursement, and so that we can do this in
15:09
Speaker 2: a staggered and staged, gated way country by country, and
15:15
Speaker 2: in a cost efficient way, and We expect to be
15:19
Speaker 2: launching in Germany where we get to set price in
15:23
Speaker 2: Q two and other countries based on HTA submissions later
15:29
Speaker 2: this year and in twenty twenty seven twenty twenty eight,
15:35
Speaker 2: because we're not going to market solely with one medicine,
15:40
Speaker 2: but also we expect that one to have additional labeled
15:44
Speaker 2: expansions and two other medicines directed to the same molecular target,
15:51
Speaker 2: three modulators of cardiac mayason, all directed to the same concentrated,
15:57
Speaker 2: tractable customer segment. We think we can build a valuable
16:03
Speaker 2: business in Europe where frankly, most companies likely could not,
16:08
Speaker 2: and we think it affords us a franchise strategy extension
16:12
Speaker 2: to Europe, similar to rationale for why we think we
16:17
Speaker 2: can build a valuable business in the United States, but
16:20
Speaker 2: for where we also know our limitations and we're partnering
16:25
Speaker 2: in Japan, China and rest of world or most of
16:28
Speaker 2: world countries.
16:30
Speaker 1: It makes a lot of sense. And you talk a
16:31
Speaker 1: lot about cost efficiency, Do you think obstructive HCM is
16:34
Speaker 1: a good market for an efficient approach? What I mean
16:37
Speaker 1: by that is, is it very concentrated in these kind
16:39
Speaker 1: of key academic centers, So you don't have to be
16:42
Speaker 1: calling on every single cardiologist across the country to actually
16:46
Speaker 1: penetrate this population exactly.
16:49
Speaker 2: So there are twenty to thirty thousand cardiologists in the country,
16:54
Speaker 2: there are roughly ten thousand that account for the majority
16:59
Speaker 2: of the treatment of hypertrophic cardimopathy. Within that, there are
17:05
Speaker 2: roughly two thousand that are currently or have previously prescribed
17:11
Speaker 2: a cardiac miasin inhibitor. I'm referring to BMS's camzios, and
17:16
Speaker 2: of those there are roughly seven hundred accounting for eighty
17:21
Speaker 2: percent of the current prescriptions. So we think in a
17:25
Speaker 2: tiered waved fashion with respect to reach and frequency, we
17:30
Speaker 2: can address where there are still quite ample opportunity. We
17:35
Speaker 2: believe BMS is currently doing a good job. They'll likely
17:39
Speaker 2: announce over a billion dollars in worldwide sales for camzios
17:44
Speaker 2: for twenty twenty five, but we think in the United
17:47
Speaker 2: States there's still over eighty percent of the market not
17:53
Speaker 2: yet penetrated, and we need to do a good job
17:57
Speaker 2: of following their lead, but also perhaps casting a wider
18:02
Speaker 2: net to be enabling of more physicians to be comfortable
18:05
Speaker 2: prescribing a cardiac miacin inhibitor. For more patients, and we
18:12
Speaker 2: do believe our strategy is well positioned for that. But
18:15
Speaker 2: to your point, we don't have to reach every cardiologist,
18:18
Speaker 2: and certainly not at the same time, it's incumbent upon
18:22
Speaker 2: us to ensure category growth and broader category penetration.
18:28
Speaker 1: Yeah, and then maybe when I think about some other
18:30
Speaker 1: kind of precision cardio launches in the past couple of years,
18:33
Speaker 1: and maybe when it comes to mind, mostly is attR cardiomyopathy.
18:39
Speaker 1: The prevalence estimates have massively increased as they continue to
18:44
Speaker 1: roll out those drugs. Do you think we could see
18:46
Speaker 1: the same thing for HCM.
18:49
Speaker 2: Yes, and I think that's a good example, but of
18:51
Speaker 2: a market that's more mature in terms of disease education, awareness, adherents,
18:58
Speaker 2: and compliance than is the market we're entering. So Pfizer
19:03
Speaker 2: did a great job, followed by Bridge biod Anylum to
19:07
Speaker 2: be enabling of that business. As we foresee, can also
19:12
Speaker 2: be the case for cardiac myocin inhibitors, and we hope
19:18
Speaker 2: to be the catalyst to be supportive of that happening,
19:22
Speaker 2: hopefully as starts with obstructive HCM, and if we are
19:27
Speaker 2: fortunate to have a positive Phase three study readout in
19:32
Speaker 2: Q two Acacia HCM is a trial that could open
19:36
Speaker 2: the aperture on non obstructive HCM and where we believe
19:42
Speaker 2: my corzo could be enabling of patients with NHCM to
19:48
Speaker 2: benefit from this pharmacology as well. So, yeah, I think
19:52
Speaker 2: what you are highlighting in the mlidosis space is a
19:57
Speaker 2: good cop or proxy for what we hope to build
20:00
Speaker 2: here and not only in the United States, but also globally.
20:05
Speaker 2: And similarly, we have the same sorts of expectations and
20:09
Speaker 2: ambitions in advanced heart failure with reduced ejection fraction as
20:15
Speaker 2: well as advanced heart failure with preserved dejection fraction. So
20:19
Speaker 2: it's core to our strategy to do just what you're describing.
20:23
Speaker 1: Okay, and then you think about your pricing strategy. It
20:26
Speaker 1: seems like your wholesale acquisition costs price is at a
20:29
Speaker 1: slight premium to Bristol's camzios. Can you talk about the
20:34
Speaker 1: underlying thinking behind that decision.
20:36
Speaker 2: Yeah, this is not a highly managed category and therefore
20:41
Speaker 2: we don't think it's in anyone's interest to compete on price.
20:46
Speaker 2: We priced at parity plus and modest premium. We don't
20:50
Speaker 2: expect to compete on market access. We believe that the
20:54
Speaker 2: clinical profile of my core Zoe should be enabling of
20:58
Speaker 2: art aspirations towards it's best in class, but it won't
21:02
Speaker 2: be based on price or market access. We think this
21:05
Speaker 2: market opportunity will be defined by classical parameters like safety, efficacy,
21:14
Speaker 2: and patient and physician experience.
21:17
Speaker 1: So I mean, HTM still is a relatively fledgling market,
21:20
Speaker 1: so you don't see it becoming more tightly managed over time.
21:23
Speaker 1: So that maybe commercial formularies choosing one or to promote
21:28
Speaker 1: over another in their formularies.
21:31
Speaker 2: We haven't seen any evidence of that. Our payer interactions
21:35
Speaker 2: would not suggest that it may happen down the road,
21:38
Speaker 2: and will be prepared for that if it is, but
21:41
Speaker 2: not at least at this time.
21:44
Speaker 1: Okay, And then I know that you're planning an sNDA
21:47
Speaker 1: filing for data from Maple HCM coming up. How do
21:50
Speaker 1: you see these data really fitting into my corso's commercial proposition,
21:54
Speaker 1: particularly in light of kind of a meta analysis recently
21:57
Speaker 1: showing improved efficacy when combining a cardc MYASIN inhibitors with
22:01
Speaker 1: beta blockers, So having that head to head might not
22:05
Speaker 1: be as meaningful to prescribers.
22:08
Speaker 2: So our pivotal study that led to this first approval,
22:12
Speaker 2: a study called Sequoia HCM showed superiority of afikampton now
22:19
Speaker 2: called my corzo as was added to beta blocker therapy
22:25
Speaker 2: versus beta blocker therapy alone. And that's the way we
22:33
Speaker 2: go to market with my corezoe because beta blockers are
22:38
Speaker 2: inexpensive and have been used for many, many years and
22:43
Speaker 2: are familiar to cardiologists, and the guidelines call for their
22:47
Speaker 2: use as first line therapy. The trial you referenced, Maple,
22:53
Speaker 2: which was presented and published in twenty twenty five, prompts
22:57
Speaker 2: a reassessment of therapy, and as the cardiology community is
23:03
Speaker 2: in the midst of understanding Maple and its implications for guidelines,
23:09
Speaker 2: we anticipate that my corzo and cardiac bias inhibition may
23:17
Speaker 2: be moving upstream in guidelines over time because Maple demonstrated
23:25
Speaker 2: head to head my corzo versus beta blockade was superior,
23:32
Speaker 2: and in fact, in that trial, beta blockade caused some
23:38
Speaker 2: harm that I think is raising eyebrows. These kinds of
23:42
Speaker 2: things don't happen overnight changing practice patterns, but it is
23:46
Speaker 2: noteworthy that this was really the first placebo controlled study
23:54
Speaker 2: of beta blockers in this disease. It was bong overdo.
24:01
Speaker 2: And what we understand is that beta blockers became a
24:05
Speaker 2: standard of care absent ample clinical evidence. Now we have
24:10
Speaker 2: had data, and it's prompting lots of questions. And I
24:14
Speaker 2: do think that the Maple data will turn heads and
24:20
Speaker 2: ultimately drive more adoption of cardiac MIAs and inhibition earlier
24:27
Speaker 2: in the treatment of these patients. Will it displace beta
24:31
Speaker 2: blockers maybe in some practices, yes, In others it might
24:35
Speaker 2: prompt them to move more swiftly through beta blockade to
24:40
Speaker 2: a cardiac miasin inhibitor once the guidelines are updated. And
24:45
Speaker 2: I can't foresee exactly how quickly that might happen, because
24:50
Speaker 2: payers may still favor beta blockers because they are inexpensive.
24:55
Speaker 2: But I do know the cardiology community is already talking
24:59
Speaker 2: about what these data they mean for changing guidelines.
25:03
Speaker 1: And then maybe as I just think more broadly about
25:05
Speaker 1: developing the HCM market and as it affects to my
25:08
Speaker 1: cors I launch what work has Bristol done so far
25:11
Speaker 1: with their CAMSIOS launch that might lay the foundation for
25:14
Speaker 1: a faster ramp for my corzo.
25:16
Speaker 2: Yeah. So education and awareness for cardiac miasin inhibition and
25:23
Speaker 2: disease awareness is high. We do different kinds of market
25:29
Speaker 2: research pre launch, and this category has benefited from BMS
25:35
Speaker 2: doing a lot of very good work in terms of
25:40
Speaker 2: seeding the marketplace with knowledge and you see direct to
25:45
Speaker 2: consumer advertising and other strategies that have been enabling of that.
25:51
Speaker 2: They've been doing this for three to four years, and
25:54
Speaker 2: we come into this market now where we don't have
25:59
Speaker 2: to do a lot of that heavy lifting. It's incumbent
26:02
Speaker 2: upon us instead to be enabling of information sharing that
26:08
Speaker 2: could broaden the number of cardiologists, perhaps outside of centers
26:13
Speaker 2: of excellence and deeper into the community who may be
26:17
Speaker 2: more comfortable prescribing. Based on what would be a new
26:22
Speaker 2: entrant into this category, I expect the work that we're
26:26
Speaker 2: going to do will be complementary and supplemental to that
26:30
Speaker 2: which BMS is doing, and it wouldn't be the first
26:33
Speaker 2: time that a second entrant into a category catalyze growth
26:38
Speaker 2: of the category. In fact, BMS is no stranger to
26:42
Speaker 2: that story. That's exactly what's happened in the antiquagulant space
26:46
Speaker 2: that they have done such a fine job to build
26:49
Speaker 2: awareness for. We hope to join them in this marketplace
26:54
Speaker 2: to be enabling of again more cardiologists comfortable prescribing for
26:59
Speaker 2: more patients.
27:00
Speaker 1: And now we can talk a lot about the second
27:02
Speaker 1: entry and growing the market, but ultimately you will be
27:04
Speaker 1: competing with Camzios. So I know there is a lot
27:07
Speaker 1: of kind of minor differences between the two labels and
27:10
Speaker 1: they're almost settled. But broadly has been initial prescriber feedback
27:14
Speaker 1: on the differences between your rams and your black box
27:16
Speaker 1: warning between camsios and my Corzo.
27:19
Speaker 2: So you characterized it as minor differences, our market research
27:25
Speaker 2: would suggests that the label and the rems make a
27:31
Speaker 2: major difference in terms of product adoption and Cydokinetics has
27:37
Speaker 2: worked very hard to be enabling of the development of
27:41
Speaker 2: AFI Campton or my Corzo as leverages its differential properties
27:49
Speaker 2: to be resulting in a differentiated label and risk mitigation
27:55
Speaker 2: profile as is captured in the rems. So if you
27:59
Speaker 2: look at our label and our rems, there are a
28:02
Speaker 2: number of things that we heard from patients and physicians
28:06
Speaker 2: they were looking for that we think we are in
28:09
Speaker 2: a position to satisfy in terms of how quickly a
28:15
Speaker 2: physician can uptight trade a patient to be enabling a
28:19
Speaker 2: relief of symptom burden. With our label that can occur
28:24
Speaker 2: with uptitration as soon as every two weeks or as
28:28
Speaker 2: long as every eight weeks, as they may prefer, but
28:32
Speaker 2: that could be enabling of a patient to get to
28:35
Speaker 2: target dose very soon, within weeks and with fewer echo
28:42
Speaker 2: cardiograms as is important. We're also looking at a label
28:49
Speaker 2: and a REMS for my corzoe that's focused to the
28:55
Speaker 2: risk associated with heart failure and not also the DDI
29:01
Speaker 2: or drug drug interaction monitoring, and as we understand from
29:06
Speaker 2: market research that has limited the adoption of the cardiac
29:12
Speaker 2: myocon inhibitor category to this point, DDI monitoring proving to
29:18
Speaker 2: be an issue with my corso, there is no such
29:23
Speaker 2: DDI monitoring or pharmacy calls that we understand can be burdensome.
29:31
Speaker 2: But also with my corso, we believe that we're creating
29:37
Speaker 2: a patient experience, a hub that's supportive of a different
29:42
Speaker 2: business model that should also be responsive to market requirements.
29:47
Speaker 2: We're deploying one sales representative for each physician office, one
29:53
Speaker 2: nurse navigator for each patient and physician office, and a
29:58
Speaker 2: patient hub variance bespoke and custom designed for this market opportunity,
30:06
Speaker 2: with a knowledge base that is specific uniquely to this opportunity.
30:11
Speaker 2: So we think the label, the rems, the patient experience,
30:17
Speaker 2: all of these are hallmarks of what we hope can
30:19
Speaker 2: be a competitive advantage as we believe we go to
30:24
Speaker 2: market with my Corzoe.
30:26
Speaker 1: You touched on the patient hub a few times, and
30:27
Speaker 1: I maybe can tay just a little bit on that
30:29
Speaker 1: and what you think is so unique about it and
30:32
Speaker 1: how you work to build that in a bespoke manner
30:34
Speaker 1: rather than I think you said it earlier relying on
30:37
Speaker 1: the older architecture of other hubs.
30:40
Speaker 2: Yeah, so we've designed this with personnel that are specifically
30:46
Speaker 2: trained on this program opportunity, and with a specialty pharmacy
30:52
Speaker 2: distribution model that is focused and disciplined to this opportunity
30:58
Speaker 2: and not otherwise plugging into an infrastructure. More diffuse, what
31:04
Speaker 2: we understand physicians, their office personnel and patients want is
31:09
Speaker 2: to know that they're dealing with the same person trained
31:14
Speaker 2: when they have to lob in a call. And it's
31:18
Speaker 2: like any customer experience you or I may have, you
31:22
Speaker 2: don't want to be on hold. You want to be
31:24
Speaker 2: talking to somebody who's experienced in this area and not
31:29
Speaker 2: otherwise a different person or an inexperienced person each time,
31:34
Speaker 2: we're measuring metrics of launch momentum and velocity, and we
31:41
Speaker 2: think that this market is ripe for where we can
31:46
Speaker 2: hopefully manage to speedier interactions, to be enabling of patients
31:53
Speaker 2: to get on medicine quicker through our hub and specialty
31:58
Speaker 2: pharmacy distribution network, but also moving more quickly through reimbursement.
32:06
Speaker 2: So cash to RX is our X to cash, I
32:10
Speaker 2: should say, is hopefully one of those things that we
32:14
Speaker 2: can accelerate with the way we do business.
32:17
Speaker 1: And you did mention as well, drug drug interactions on
32:20
Speaker 1: the labels for camsios, and I know that they're I
32:23
Speaker 1: think they're CIP four point fifty inhibitors and inducers increasing
32:27
Speaker 1: the risk of heart failure. Has your market research identified
32:30
Speaker 1: any drugs in this class that are kind of used
32:33
Speaker 1: pretty prevalently in the HCM population.
32:36
Speaker 2: Yeah, So I'm not here to say anything that could
32:40
Speaker 2: subtract from dms or chemsios, but I do think that
32:46
Speaker 2: their label contains drug drug interactions that would mean in
32:51
Speaker 2: our market research would suggest has been a matter of
32:56
Speaker 2: issue or concern with regard to some commonly persons bribed
33:01
Speaker 2: medicines for these patients. That's not we believe an issue
33:06
Speaker 2: for my core zoe. You know, I neglected to mention
33:10
Speaker 2: something that I think is also important. My corso has
33:15
Speaker 2: a half life that is a few days, and patients
33:20
Speaker 2: can get to steady state within a week to two weeks.
33:26
Speaker 2: That's enabling of a clinical development program that generated evidence
33:32
Speaker 2: to support differentiation in our label, and in particular, as
33:38
Speaker 2: patients here are at risk of at higher exposures, the
33:46
Speaker 2: potential for ejection fraction to fall below fifty percent. In
33:53
Speaker 2: the case of my corso, that can be addressed with
33:57
Speaker 2: a down titration. If it's below forty percent, that's a
34:02
Speaker 2: dose interruption. In our clinical trials and patients with OHCM,
34:08
Speaker 2: we saw no such dose interruptions and only a modest
34:13
Speaker 2: number of dose down titrations. We saw no hospitalizations for
34:19
Speaker 2: heart failure. We think that can be enabling of physicians
34:24
Speaker 2: to be comfortable with my corzo because it has a
34:28
Speaker 2: flatter relationship between its pharmacokinetics, exposure and its pharmacodynamics, and
34:35
Speaker 2: that should be hopefully enabling of an ease of use,
34:39
Speaker 2: a convenience, and a flexibility with my corzo that we
34:43
Speaker 2: think may be a hallmark of its use and as
34:47
Speaker 2: again should hopefully be supportive of more cardiologists comfortable prescribing
34:52
Speaker 2: my corzo for more patients.
34:55
Speaker 1: It don't be interesting to watch the initial days of
34:57
Speaker 1: the MI corset launch here being away from obstructive HCM
35:01
Speaker 1: to non obstructive HCM. You're currently running the ACACIA HCM
35:06
Speaker 1: study for this indication. I think, just from a high level,
35:09
Speaker 1: in the past, you've said the HCM market is fifty
35:12
Speaker 1: to fifty obstructive and non obstructive. But do you think
35:16
Speaker 1: there's any ways these patient populations differ in terms of symptoms, severity,
35:20
Speaker 1: willingness to seek treatment, diagnose its rates, and so on
35:23
Speaker 1: and so forth, just thinking about the market dynamics.
35:26
Speaker 2: Yeah, So just last week we published with academic authors
35:31
Speaker 2: a very important publication that underscores what you said regarding
35:36
Speaker 2: a shift in mindset. It used to be thought that
35:39
Speaker 2: NHCM represented maybe a third to forty percent of total HCM,
35:45
Speaker 2: but claims data and longitudinal analysis would suggest it's more
35:49
Speaker 2: like fifty to fifty. But to your point, there our
35:52
Speaker 2: differences with OHCM because of the thickening of the anatomy.
35:57
Speaker 2: There's a pressure gradient that cardiologists can monitor and use
36:02
Speaker 2: as a touchstone for titration of a medicine for the
36:09
Speaker 2: treatment of HCM. You don't have that in NHCM. You
36:14
Speaker 2: do have probably equal severity of symptoms to your question,
36:20
Speaker 2: but it manifests differently and absent a pressure gradient. I
36:24
Speaker 2: think physicians are looking for other ways to manage these patients.
36:30
Speaker 2: That's where I think the Acacia study may hopefully be
36:34
Speaker 2: a seminal study for the use of a cardiac miasin
36:38
Speaker 2: inhibitor in these patients. We've designed and have conducted a
36:43
Speaker 2: study called Acacia that's going to read out in the
36:47
Speaker 2: second quarter and based on things we know, and we
36:52
Speaker 2: have caucused experts in NHCM over several years. In fact,
36:57
Speaker 2: we hired several of them to design and oversee the
37:01
Speaker 2: conduct of this study. We believe we've enrolled the right
37:05
Speaker 2: patients in the right centers for this experiment, which is
37:11
Speaker 2: to say, does a cardiac myosin inhibitor offer a treatment
37:15
Speaker 2: option for these patients where right now they have no
37:18
Speaker 2: approved treatment. BMS conducted a study called Odyssey of Camzios
37:26
Speaker 2: in a similar population and that study unfortunately failed, but
37:32
Speaker 2: it was a near miss, and we think it was
37:35
Speaker 2: encouraging to the therapeutic hypothesis, and we believe that ACACIA
37:41
Speaker 2: was designed and the conduct of that trial has us
37:46
Speaker 2: optimistic that we may see a positive study in Q two.
37:52
Speaker 1: And I'm glad you touched on aUI ATM and also
37:55
Speaker 1: the different set of symptoms between obstructive and non obstructive,
37:58
Speaker 1: because when I look at a trials and non obstructive,
38:01
Speaker 1: it seems like the placebo response rates on measures like
38:03
Speaker 1: the Kansas City cardiom Myopathy Questionnaire PEW to B directionally
38:08
Speaker 1: greater than in obstructive HCM. So how do you think
38:11
Speaker 1: about controlling this as a risk for ACACIA.
38:14
Speaker 2: So it's both a risk and what could hopefully be
38:18
Speaker 2: a telltale sign of a symptom burden relief, which KCCQ
38:24
Speaker 2: has consistently both an obstructive and in our Phase two
38:30
Speaker 2: non obstructive been one of those early harbingers of treatment
38:38
Speaker 2: efficacy we've seen over and over and over now where KCCQ,
38:44
Speaker 2: which has a high fidelity read to patient symptoms, is
38:52
Speaker 2: where AFI Campton or Mike Corzo shows up at its best.
38:57
Speaker 2: In Phase two, we saw outsized treatment efficacy with AFI Campton,
39:05
Speaker 2: albeit in an open label fashion, but even controlling for
39:10
Speaker 2: place historical placebo event rates, we saw very large magnitude
39:16
Speaker 2: efficacy of Afi Campton in patients with NHCM. We've consulted
39:23
Speaker 2: with the gentleman who has designed and has been implementing
39:30
Speaker 2: KCCQ over decades and with FDA, where there's a high
39:36
Speaker 2: test retest reliability and a pretty well known and calibrated
39:43
Speaker 2: placebo response rate that tracks study to study with KCCQ.
39:50
Speaker 2: So we believe we've powered our study ACACIA knowing that
39:55
Speaker 2: there is a placebo response rate typically between four and
40:00
Speaker 2: six and where we believe if Hafi Campton or my
40:06
Speaker 2: Corzo is going to be effective in this population, we've
40:10
Speaker 2: designed the right study.
40:12
Speaker 1: So as we think, I read throughs from your phase
40:15
Speaker 1: two study, I think it was Redwood HCM. How I mean,
40:19
Speaker 1: obviously it's very small. It was a relatively small trial,
40:21
Speaker 1: less than two hundred patient sort of Phase two. Can
40:24
Speaker 1: you speak to how representative that trial population was of
40:27
Speaker 1: the non obstructive HCM population and any potential differences you
40:31
Speaker 1: might see in baseline characteristics in AKASHA.
40:34
Speaker 2: So we haven't yet commented on the baseline characteristics in AKASHA,
40:40
Speaker 2: but I will say that those individuals here at Csutokinetics,
40:45
Speaker 2: who designed both Redwood and Acacia, did what one should
40:51
Speaker 2: expect of them in clinical research. They piloted a dose
40:58
Speaker 2: strategy that is the same strategy we took from phase
41:02
Speaker 2: two to phase three. They're going to the same centers
41:06
Speaker 2: that have experience with patients with NHCM and these efficacy endpoints.
41:14
Speaker 2: And what we know from having done studies in these
41:18
Speaker 2: centers is experience matters. Experience amongst the investigator but also
41:25
Speaker 2: their office personnel and their training as it relates to KCCQ.
41:31
Speaker 2: As I mentioned, the training of the KCCQ matters and
41:38
Speaker 2: whether we're doing that in the United States, Europe, or
41:40
Speaker 2: even China. We're working with that person who designed the
41:46
Speaker 2: KCCQ to conduct the training understanding the failure modes. And
41:53
Speaker 2: are colleagues internal Decidokinetics who are overseeing the conduct of
41:59
Speaker 2: the study. They look as they are experienced to do
42:04
Speaker 2: at every single echo and they ask questions of investigators
42:11
Speaker 2: if they have any concerns about whether a patient may
42:16
Speaker 2: not meet criteria and why do I mention that because
42:21
Speaker 2: in NHCM, as you mentioned before, absent a gradient and
42:25
Speaker 2: echo can tell you important things and it can also
42:30
Speaker 2: raise a question as to whether there may be a
42:33
Speaker 2: patient phenocopying to NHCM, but maybe they have emloidosis or
42:39
Speaker 2: some form of HEFPETH. So it's imperative that we ensure
42:43
Speaker 2: we've screened in the right patients and screened out the
42:48
Speaker 2: wrong patients as they know well to do.
42:53
Speaker 1: It seems that you think two areas of differentiation for
42:55
Speaker 1: Akasha on trial conduct is going to be enrollment screening
42:59
Speaker 1: and then also conduct of the CASECQ.
43:02
Speaker 2: Yes, I think so, and also conduct of the measures
43:08
Speaker 2: of exercise stamina or fatigue, which includes the peak vevo two.
43:17
Speaker 2: How is that measured and how do we ensure quality
43:21
Speaker 2: control of that. We've seen for having done exercise studies
43:26
Speaker 2: in cardiology before even AFI Campton, we understand a lot
43:33
Speaker 2: about how to pick the centers and how to make
43:37
Speaker 2: certain they're properly trained, whether or not they're using bicycle
43:42
Speaker 2: or treadmill. These things matter and you have to be
43:45
Speaker 2: conscious of those as you're picking sites and picking investigators. Yep.
43:52
Speaker 1: And I think one of the key different from when
43:54
Speaker 1: we look at Redwood terrication the translation you're going from
43:57
Speaker 1: you're going now to forty eight week treatment, So how
44:01
Speaker 1: do you see CACTQ developing from their Redwood time point
44:06
Speaker 1: to the Acacia time point. Is there a potential for
44:09
Speaker 1: a ceiling effect is what I'm kind of getting at,
44:11
Speaker 1: or a plateau.
44:13
Speaker 2: So keep in mind that we are measuring our primary
44:17
Speaker 2: efficacy endpoint not at twenty four but at thirty six.
44:21
Speaker 2: But there are patients that stay on afterwards. And we
44:26
Speaker 2: do believe that because we can get to target dose rapidly,
44:31
Speaker 2: and we've demonstrated that with Redwood HCM Cohort four that
44:38
Speaker 2: patients are on their target dose with adequate exposure to
44:43
Speaker 2: see the effects out to thirty six weeks. After that,
44:47
Speaker 2: there may be a plateauing of effect, and that's echoed
44:52
Speaker 2: also in how we're conducting an open label extension called
44:56
Speaker 2: Forest where we believe that data with OHCM our informative
45:02
Speaker 2: of NHCM, and there we've presented data out to two
45:08
Speaker 2: years and we see where patient response can plateau. So
45:13
Speaker 2: we think we've designed the right trial and duration and
45:17
Speaker 2: time point to assess efficacy as we are doing indication.
45:23
Speaker 2: But we'll know soon enough with data in Q two.
45:26
Speaker 1: Okay, great May fifteen years now from afi Caampton to
45:29
Speaker 1: your other late stage program Omacampton Macarbel. Do you want
45:33
Speaker 1: to just give your thoughts in the brief history of
45:35
Speaker 1: the development program for this and then what informed your
45:37
Speaker 1: decision to bring it back in house fully?
45:40
Speaker 2: Yeah, So I'm not sure I could say it's a
45:42
Speaker 2: brief history, because this has been going on since two
45:45
Speaker 2: thousand and five two thousand and six when Omycampton Macarbel
45:51
Speaker 2: entered clinical trials and has been the subject of over
45:55
Speaker 2: thirty studies either we conducted or am Gen conducted when
46:00
Speaker 2: we were then in collaboration, including a Phase three study
46:04
Speaker 2: that m GEN conducted called Galactic that enrolled over eight
46:09
Speaker 2: thousand patients and was positive p less than point zero
46:14
Speaker 2: five for a hard clinical endpoint, but it admittedly was
46:19
Speaker 2: modestly positive, and the FDA asked us because it wasn't
46:24
Speaker 2: less than point one, to do a confirmatory study. We
46:29
Speaker 2: had sought to advise m GEN that, based on our
46:33
Speaker 2: understandings of the mechanism of action in biology, that the
46:37
Speaker 2: treatment effect would be more pronounced in sicker patients with
46:42
Speaker 2: lower ejection fraction, and we were right, but we were
46:47
Speaker 2: unsuccessful in persuading m GEN to enroll patients with lower
46:55
Speaker 2: ejection fractions in that pivotal phase three study, and much
47:01
Speaker 2: as we expected, what we saw in the final data
47:06
Speaker 2: was that patients with lower ejection fractions had a more
47:10
Speaker 2: than doubling of the effect on meaningfully hard clinical endpoints,
47:16
Speaker 2: and those with higher ejection fractions diluted the overall treatment
47:20
Speaker 2: effect as observed. So we had in that eight thousand
47:27
Speaker 2: patient study four thousand patients either on placebo or active.
47:33
Speaker 2: That informs now the confirmatory study which is going to
47:38
Speaker 2: enroll approximately eighteen hundred patients to verify what we saw
47:43
Speaker 2: in Galactic that patients who have lower ejection fraction, recent hospitalizations,
47:50
Speaker 2: higher B and PS, these measures of advanced heart failure
47:56
Speaker 2: should hopefully enable us with this smaller, more focused confirmatory
48:02
Speaker 2: trial to recapitulate what we saw in Galactic, and as
48:06
Speaker 2: would be supportive, we believe of if positive, an approval
48:11
Speaker 2: for only CAMPED in a population where existing treatments for
48:15
Speaker 2: heart failure are not useful. We're not seeing those drugs
48:21
Speaker 2: beta blockers SQOT two inhibitors used in these patients that
48:25
Speaker 2: are repeat frequent flyers in US hospitals because of advanced
48:30
Speaker 2: heart failure with higher morbidity's lower ejection fraction, So the
48:35
Speaker 2: cardiology community gets it and is very excited about commat
48:40
Speaker 2: hf AS is enrolling approximately eighteen hundred patients its event driven,
48:46
Speaker 2: so we don't know exactly how many patients will ultimately
48:49
Speaker 2: be needed, but we do believe that it's enrolling well
48:54
Speaker 2: and we should see results of that study in the
48:57
Speaker 2: next couple of years as could be supportive of an
49:01
Speaker 2: approval for only CAMPED of macarbell in advanced severe heart failure.
49:06
Speaker 2: And there again many of the same cardiologists similar strategy
49:12
Speaker 2: concentrated customer segment. The second leg on our stool, if
49:17
Speaker 2: you will, following my corzo as, we'd hopefully establish for
49:22
Speaker 2: us a commercial presence in OHCM and potentially NHCM and
49:27
Speaker 2: then where own camptive could carry the flag into heart
49:32
Speaker 2: failure with reduced ejection fraction. And then to your question,
49:37
Speaker 2: we have another investigational medicine ulacampton in heart failure with
49:43
Speaker 2: preserved dejection fraction that's currently the subject of a phase
49:48
Speaker 2: two study called amber HAFEF. That study is enrolling. We
49:54
Speaker 2: may be in a position to report data from that
49:57
Speaker 2: trial here soon. That being the third leg of the
50:01
Speaker 2: three legged stool for our emerging specialty cardiology franchise, so
50:06
Speaker 2: you begin to understand how the science, clinical research, and
50:10
Speaker 2: commercial strategies produce. We believe a symbiotic and cohesive connection
50:17
Speaker 2: to be supportive of a growth and enduring business to
50:21
Speaker 2: benefit not just patients but also shareholders.
50:25
Speaker 1: Maybe just going back to Emacanton Maccarbo for a second,
50:27
Speaker 1: just you'd mentioned it briefly that these severe heart failure
50:31
Speaker 1: patients are better suited for treatment with Omacanton Macarbo than
50:35
Speaker 1: maybe the broader half ref population. Can you actually describe
50:38
Speaker 1: what's different about them that does make them better suited
50:41
Speaker 1: for it.
50:42
Speaker 2: Yeah, So these are patients who, despite standard of care,
50:46
Speaker 2: still have reduced cardiac pumping function. The medicines, to our
50:52
Speaker 2: earlier conversation, the medicines that they're often getting are not
50:56
Speaker 2: acting directly on cardiac mechanics or muscle for formance, but
51:01
Speaker 2: are addressing downstream sequentae of their heart failure, things like
51:09
Speaker 2: blood pressure, things like heart rate, things that relate to
51:14
Speaker 2: the electrical system or the vasculature, but not the underlying
51:20
Speaker 2: etiology or pathophysiology of their advanced disease, which is rooted
51:26
Speaker 2: it impaired cardiac muscle function. So to address their needs,
51:32
Speaker 2: one needs a medicine like an isotrope, but inotropes are
51:39
Speaker 2: oftentimes because of their mechanism, operating on a very delicate
51:45
Speaker 2: risk benefit balance, and OMI camped of Macarbel is a mayotrope.
51:51
Speaker 2: It works by a different mechanism and by activating cardiac myosin,
51:57
Speaker 2: it can extend systolic injection time, the time that the
52:02
Speaker 2: heart is actually contracting blood, restoring that back towards normal
52:10
Speaker 2: and augmenting cardiac muscle performance and function where that's not
52:16
Speaker 2: addressed with standard of care medicines. So we believe there
52:20
Speaker 2: are roughly four to five million patients in the United
52:24
Speaker 2: States and growing with heart failure, but they're about a
52:28
Speaker 2: million of them who have advanced or severe heart failure,
52:33
Speaker 2: and one needs a better pharmacotherapy for them that gets
52:37
Speaker 2: to the root cause of their disease. Yep.
52:40
Speaker 1: So it kind of tenches back in our earlier discussion
52:42
Speaker 1: on the shift of cardiology to precision medicine. That's right,
52:46
Speaker 1: And then maybe if you can just wrap it up
52:47
Speaker 1: with ULA Campton, which is another cardiac myocin inhibitor but
52:51
Speaker 1: has a slightly different mechanism from Afacampton and Mavicampton. Can
52:56
Speaker 1: you describe how the mechanism actually differs into the has
52:59
Speaker 1: at similar target if they're not the same target, and
53:02
Speaker 1: why it would be uniquely positioned for half path or
53:05
Speaker 1: heart failure with preserved dejection for action.
53:08
Speaker 2: Yeah, so we're still learning about Eulacampton, but we do
53:11
Speaker 2: believe by its different mechanism and it has a different
53:15
Speaker 2: binding site than does AFI Campton, we do believe it
53:20
Speaker 2: renders it potentially as could be enabling of a different
53:24
Speaker 2: dosing strategy, perhaps not even requiring a co cardiographic data
53:31
Speaker 2: to support its use in heart failure and preserved dejection
53:34
Speaker 2: fraction and half PEF in some ways resembles NHCM. So
53:42
Speaker 2: the Acacia data with AFI Campton may inform strategy for
53:47
Speaker 2: Eulacampton in half peth. And we have other ongoing research
53:53
Speaker 2: with other cardiac myosin inhibitors that extend our leadership in
53:58
Speaker 2: this pharmacology. So we intend to not only have pioneered
54:03
Speaker 2: this space, but continue to lead and dominate. And half
54:07
Speaker 2: path is one of those frontiers where we believe we
54:11
Speaker 2: can make a meaningful impact. But I also mentioned helfpeth
54:15
Speaker 2: is itself a constellation of diseases, a continuum if you will,
54:21
Speaker 2: there are those helf peth patients who have more of
54:24
Speaker 2: the metabolic form of the disease and where SGOT two
54:29
Speaker 2: inhibitors may be a better medicine for them, And those
54:32
Speaker 2: who have the hyper contractility form of the disease, where
54:37
Speaker 2: a cardiac myocin inhibitor may be better suited for them.
54:41
Speaker 2: So that's what we're learning through ongoing clinical research. But
54:45
Speaker 2: our focus is where the anatomy is producing a syndrome
54:52
Speaker 2: of preserved ejection fraction even higher than sixty five percent,
54:58
Speaker 2: and where a cardiac myosin inhibitor may be more appropriate than,
55:04
Speaker 2: for instance, other drugs working more on cardio metabolic pathophysiology.
55:12
Speaker 1: Absolutely too, I mean, obviously it depends on the findings
55:15
Speaker 1: from Amber, but could we potentially see a pivotal program
55:18
Speaker 1: looking at the hypercontractile phenotype of half pefit? Is that
55:22
Speaker 1: broader half peth?
55:24
Speaker 2: Yes, that's the aim. Yeah, we're moving with some urgency
55:28
Speaker 2: towards making that happen, and I hope that we'll have
55:32
Speaker 2: data in twenty twenty six to inform that strategy as
55:36
Speaker 2: could be pivotal in twenty twenty seven.
55:39
Speaker 1: And then I know that Eula Campton has a relatively
55:42
Speaker 1: unique pharmacokinetic profile relative to other cardiac mycin inhibitors. I
55:46
Speaker 1: believe it's a shorter half life. But do you think
55:48
Speaker 1: that would lead to a less of a deleterious effect
55:51
Speaker 1: on ejection fraction compared to Afacampton and Mavicampton.
55:56
Speaker 2: Yes, I think it could. Again, how would effect diastolic function,
56:01
Speaker 2: How it affects systolic function. These are things we're learning
56:05
Speaker 2: in phase two. We're measuring those very metrics, and I
56:11
Speaker 2: think based on what we know pre clinically, we have
56:14
Speaker 2: reason to believe and will know more in humans soon enough.
56:19
Speaker 1: I think that's all the questions we have time for.
56:22
Speaker 1: But is there anything you wanted to highlight or you
56:24
Speaker 1: wish we had spoken more about by the side of
56:26
Speaker 1: kinetics story today.
56:27
Speaker 2: Yeah, So I'll mention one other thing. Cytokinetics is enabled
56:33
Speaker 2: to do what we're doing in science and for the
56:36
Speaker 2: benefit of medicine and patience because of the way we've
56:40
Speaker 2: approached the business all these many years, how we access
56:44
Speaker 2: and deploy capital, how we leverage partnerships from a business
56:48
Speaker 2: and corporate development standpoint. I think our partnering which includes
56:54
Speaker 2: both pharma companies biopharma companies, and how we monetize royalties
57:02
Speaker 2: has enabled us to be thinking like good stewards of
57:06
Speaker 2: shareholder capital and equity. Now as we turn the page
57:11
Speaker 2: onto commercialization, we have a strong balance sheet, We have
57:16
Speaker 2: options to draw down on other capital if that proves
57:20
Speaker 2: to be a good strategy. We have the ability to
57:24
Speaker 2: pull levers. And I think if there's anything I've learned
57:28
Speaker 2: in over forty years in this arena is it's important
57:33
Speaker 2: to diversify not only technical risk, but how we approach
57:37
Speaker 2: business risk. And I think Putokinetics is perhaps one of
57:41
Speaker 2: those companies that's set the high water mark on the
57:46
Speaker 2: way in which we integrate business strategy with R and
57:50
Speaker 2: D strategy, and that should continue as a hallmark of
57:53
Speaker 2: how we go to market commercially.
57:56
Speaker 1: Absolutely, and we'll be watching that my corset launch closely.
57:59
Speaker 1: Robert thinks so much for the time today, and thank
58:01
Speaker 1: you to everyone for listening to another episode of Vanguards
58:03
Speaker 1: of Healthcare.