Cytokinetics, Incorporated

Good afternoon, and welcome to Cytokinetics' first quarter 2025 conference call. At this time, I would like to inform you that this call is being recorded and that all participants are in a listen-only mode. At the company's request, we will open the call to questions after the presentation. We will allow for only one question per participant. I will now turn the call over to Diane Weiser, Cytokinetics Senior Vice President of Corporate Affairs. Please go ahead.

Good afternoon, and thanks for joining us on the call today. Robert Blum, President and Chief Executive Officer, will begin with an overview of the quarter and recent developments. Andrew Callow, EVP and Chief Commercial Officer, will address commercial readiness activities for Affy Campton. Fatty Malik, EVP of R&D, will provide updates related to the clinical development program for Affy Campton. Stuart Kupfer, SVP and Chief Medical Officer, will provide updates on the clinical development of Omicamp and McCarville and CK5H6. Isaac C. Hanover, EVP, Corporate Development and Chief Business Officer, will provide an update on business development in the context of our corporate development. Sung Lee, EVP and Chief Financial Officer, will provide a financial overview of the past quarter. And finally, Robert will review our expected key milestones for the remainder of 2025. Please note that portions of the following discussion, including our responses to questions, contain statements that relate to future events and performance rather than historical facts and constitute forward-looking statements. Our actual results might differ materially from those projected in these forward-looking statements. Additional information concerning factors that could cause our actual results to differ materially from those in these forward-looking statements is contained in our SEC filings, including our current report regarding our first quarter 2025 financial results filed on Form 8K that was furnished to the SEC today. We undertake no obligation to update any forward-looking statements after this call. And now I will turn the call over to Robert.

Thank you, Diane, and thanks to all for joining us on the call today. The first quarter provided a strong start to the year, laying a solid foundation for the increased momentum we're building as we approach a pivotal step towards potential commercialization. Of course, Our principal focus is on our new drug application for afecamtin. As we disclosed last week, the FDA extended the PDUFA date for the NDA for afecamtin for the treatment of patients with OHCM to December 26, 2025, to provide additional time to conduct a full review of our proposed revs. And to be clear, we had a series of three meetings with FDA ahead of our NDA submission for afecamtin, during which we discussed a range of topics related to the content of our submission, including safety monitoring and risk mitigation strategies. These included a top line meeting to review the results of Sequoia HCM, a pre-MDA meeting to cover specific topics related to our submission, and a Type B meeting during which we discussed strategies related to safety monitoring and risk mitigation in support of our MDA submission. attending all three of these meetings were representatives from the Division of Cardiology and Nephrology, as well as representatives from the Division of Risk Management within the Office of Surveillance and Epidemiology of FDA. As we've previously shared, these interactions provided the opportunity to discuss in detail the data supporting the safety and intrinsic pharmaceutical properties of Afikampton. and how they may inform approaches to manage risk and gain insight into FDA's perspectives on this matter. Given these interactions, we considered it reasonable to propose a distinct risk mitigation approach specific to Affy Campton and based on labeling and other tools such as voluntary education materials. However, we understood from FDA that the potential need for a REMS would be a focus of the agency's review. We made the determination to take this approach because under the circumstances, we thought it was reasonable given the profile of Affy Campton. However, as a contingency, we developed our distinct REMS proposal and we were well prepared to submit it if necessary. During the NDA review, Given the mechanism of Afikanton, the FDA requested that we submit a REMS specific to its intrinsic properties, which we promptly provided. As we communicated last week, we recently learned from FDA that our subsequent submission of the REMS constitutes a major amendment to the NDA and will now require a standard three-month extension to the original QDUFA action date. To remind you, please, We discovered and developed afecamtin with objective to advance it as a potential next in class cardiac myosin inhibitor. Based on its inherent characteristics, we evaluated it in preclinical and clinical studies to understand how its half-life, its rapid onset, its reversibility, as well as an optimized relationship between PK and PD could enable a unique convenient dosing regimen. We extensively studied its DDI profile to similarly ensure that it was enabling of a distinct clinical profile to support potential differentiation. We believe the results of our clinical studies, including Sequoia HCM and Forest HCM, support a potential label and risk mitigation profile that, if approved by FDA, will differentiate afecamtin. Nothing has changed in that regard. And again, to confirm, no additional clinical data or studies were requested by FDA. As we disclosed in an 8 filing in March, during the first quarter, we completed a mid-cycle review with FDA. During the meeting, FDA confirmed that the agency does not plan to convene an advisory committee meeting, which is consistent with prior communications to us, and that our late cycle meeting is expected to occur in June. While the PDUFA extension does delay the potential approval of Affy Campton, it does not change our confidence in its distinct benefit-risk and pharmaceutical profile. nor does it change our expectation for a potentially differentiated label and risk mitigation profile upon potential approval. Given the FDA review of the NDA is ongoing, we do not intend to provide further color or detailed updates on our communications with FDA. Moving on. During the first quarter and recently, we also advanced regulatory activities outside of the U.S. In April, we received 120-day questions from the EMA regarding the MAA for Affy Campton in Europe, and we're now working to develop responses. I'm pleased to share that we believe we are on track for potential approval by EMA in the first half of 2026. During the quarter, we also worked with Sanofi, our partner in China, to support the NDA review of Affy Campton with the NMPA. And overall, we're encouraged by the steady progress of our regulatory interactions globally. Moving to other activities, in the first quarter, we continue to dial up our commercial readiness, not only in the US, but also in Europe. As Andrew will elaborate, during the quarter, we made key strides on all commercial planning work streams. Yes, the PDUPA date extension will shift out certain elements of our commercial readiness, but we are moving forward with launch planning. In the first quarter, we also achieved meaningful milestones in our ongoing clinical trials program for Affy Campton. We're pleased to share today that we plan to report top line results from Maple HCM this month. If the results are positive, we believe these data may represent a potential label expansion opportunity for Affy Campton following an initial potential FDA approval in OHCM. In addition to OHCM, we're also focused on NHCM, in which there is a significant unmet need for effective treatments. And with increasing recognition and diagnosis of the condition, the market opportunity continues to grow. We're pleased to share today that Acacia HCM, our Pivotal Phase III Clinical Trial of Affecampton in NHCM, has completed enrollment in the first quarter, months ahead of schedule, enabling us to read out the top line results in the first half of 2026. Patty will elaborate on this achievement, as well as on some additional updates that we made to the trial, as guided by global regulatory feedback. As the prevalence rate of NHCM rises, we remain optimistic regarding the promise of Affy Campton in this top population of underserved patients. As you know, ApiCampden for the treatment of both O and N HCM represents the first potential new medicine arising from our specialty cardiology franchise, which also includes Omicampden McCarble and CK586, each advancing in respective later stage clinical trials in two different forms of heart failure. The progress we made in the first quarter reflects thoughtful planning, disciplined resource management, and a steadfast commitment to rigorous clinical research, all of which propel us towards our ambitious Vision 2030. And with that, I'll turn the call over to Andrew, please. Thanks, Robert. In the first quarter, we continued to execute our commercial readiness planning and implementation. With a three-month extension to our producer Certain workstreams will be adjusted, but we're not losing our sense of urgency or launch readiness momentum. This year has been focused to building, implementing, and executing our go-to-market plans, as we intend to keep building this momentum towards our revised December PDUFA date. During the first quarter, we initiated our Salesforce recruiting. Given the December PDUFA date, we'll be revising our Salesforce onboarding plan while maintaining current recruiting schedule. which is off to a great start. To date, we received several thousand applications, many from highly qualified sales professionals with a majority possessing abundant cardiology experience and existing relationships, giving us a strong talent base from which to identify top candidates for these positions. In late April, we held a virtual recruiting webinar for sales professional candidates that grew nearly 1,000 attendees. These figures show high level of interest and how well positioned we are to attract top talent and build a standout SALS organization. In parallel, our work around SALS operational planning continued, including analytics, targeting, incentive comp, as well as finalizing the SALS training curriculum. We are also building our bespoke patient support program by integrating our strategic partners into a seamless, patient-focused implementation. We also finalized selection of our channel distribution partner and specialty pharmacy partners. During the quarter, we continue to refine our promotional launch campaign for HCPs and patients, accounting for the most recent market dynamics, HCP advisory boards, as well as primary market research testing. At the same time, our ungranted disease awareness campaign, HCM Beyond the Heart, continues. The HCP-focused awareness campaign directs HCPs to consider the broader HCM burden and practice whole-person care. And likewise, the patient campaign helps educate people living with HCM, not just about the condition, but about the holistic burden of HCM. We also maintained our engagement with payers and plan to continue educating them on the data from the clinical development program of Forafi-Campden, as well as the clinical and economic burden of HCM. On top of the burden of disease, we expect to have several HEOR presentations at upcoming meetings to further characterize both O and N HCMs. and deepen understanding of the disease. To that point, an exciting milestone during the first quarter was our launch of Earth HCM, an online, open-access, interactive public health education tool developed in collaboration with leading academic institutions. Outside of our U.S. commercial planning, we advanced European commercial ratings and activities in a gated manner, including hiring key leadership positions for marketing, finance, legal, compliance, and human resources. and we set up new regional entities in France and the U.K. with in-country leaders. During the quarter, we also validated our reimbursement strategy and country launch sequence, which, as we previously stated, begins with Germany in 2026, pending EMA approval. Finally, we began dossier preparation for HTA submission across multiple geographies. To summarize, we've made progress in our commercial readiness activities over the past quarter and will continue to finalize a robust commercial framework to support the potential U.S. and European launches of africansin. With that, I'll turn the call over to Fadi to share updates on our ongoing clinical trial program for africansin.