Cytokinetics, Incorporated

mode. After the speaker's remarks, we will open the call to questions. We will allow for one question per participant. If you would like to ask a question during this time, simply press the star followed by the number one on your telephone keypad. If you would like to withdraw your question, please press the star one again. I would now like to turn the call over to Diane Weiser, Platykinetics 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 Kellis, EVP and Chief Commercial Officer, will address commercial readiness activities for Affy Campton. Betty Malek, EVP of R&D, will provide updates related to the clinical development program and medical affairs activities for Affy Campton. Stuart Kupfer, SVP and Chief Medical Officer, will provide updates on the clinical development program for Omicamp and CK586, which is now called Eulacamp. Emily, EVP and Chief Financial Officer, will provide a financial overview of the past quarter. And finally, Robert will provide closing comments and 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 second 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 half of this year has been defined by solid progress as we continue to deliver on key milestones that bring us closer to realizing our vision, a vision of being the leading muscle-focused specialty biopharma company intent on meaningfully improving the lives of patients through global access to our innovative medicines. During the second quarter, we announced that the FDA extended our PDUFA date for the NDA for Affy-Campden for the treatment of patients with OHCM to December 26, 2025. Our late cycle review meeting has since been moved to September consistent with the three-month PDUFA extension. We believe this timing should have no bearing on the approvability of Affy-Campden And we look forward to that meeting with FDA as we expect will occur soon and inform our next steps. In the meantime, all activities expected alongside the FDA's ongoing review process continue to timeline. For example, GCP inspections of clinical trial sites and also of cytokinetics by FDA are now completed with no observations recorded. In addition, we're maintaining a productive dialogue with FDA and we're answering questions to support their review of the NDA. Also, during the quarter, we had a collaborative meeting with FDA on our submitted REMS program following their initial review. Subsequent to the meeting, we promptly submitted an updated REMS package and during, or rather despite the extension to the PDUFA date, we remain confident in the U.S. regulatory position of Affy-Campden, given the quality of our clinical data, perceived alignment on a REMS program, and ongoing collaborative dialogue with FDA. We also maintain strong conviction that the data behind Affy-Campden support its potential FDA approval, its distinct benefit-risk and pharmaceutical profile, and potentially differentiated label and risk mitigation profile as a potential new treatment option for patients with OHCM. At the same time, regulatory reviews for Affy-Campden continued during the second quarter in both Europe and in China. In April, we received the day 120 list of questions from EMA regarding the MAA for Affy-Campden in Europe and, We're on track to submit responses soon in accordance with the timeline agreed with the EMA. EMA inspections of clinical sites and of cytokinetics have also been completed with the overall conclusion that the conduct of the phase three trial was compliant with regulations and guidelines and data are acceptable and reliable. We remain on track for potential approval by EMA in the first half of 2026, and we're targeting Germany for our first potential launch following approval. We have also been working closely with Sanofi, our partner in China, to support the NDA review of afikamtin with the NMPA, and that's on accelerated regulatory pathway for innovative therapies. We look forward to the prospect of bringing afikamtin to patients in additional geographies, and we continue to expect potential approval in China in the second half of this year. Moreover, in the past few months, our commercial launch readiness activities have advanced with increased intensity and focus, and we're taking advantage of the extra time to further strengthen our commercial launch and our operational strategies in the U.S. As Andrew will elaborate, Key progress areas in the second quarter include recruiting a world-class U.S. sales force, fine-tuning our patient-centric treatment experience, and engaging key payers and also other important stakeholders. During the quarter, we also made important progress in our ongoing clinical trials program for Affy Camden. Notably, we announced positive top-line results from Maple HCM, We look forward to expanding on these results and their implications for what standard of care treatment may look like in OHCM following the presentation of the primary results at the upcoming European Society of Cardiology Congress to occur later this month. We also continued conducting ACACIA HCM, the pivotal phase three clinical trial in NHCM, which is now fully enrolled. and towards our expected top line readout in the first half of next year. NHCM represents an area of significant unmet need, and it's growing within the overall HCM population with no approved treatment options that address the underlying disease. Following the first potential approval in OHCM, NHCM represents a clear opportunity for Affy-Campden and innovation. Beyond Affecampton, in Q2, we continued to advance patient enrollment in Common HF and also in Amber Hef-Pef, our two later stage clinical trials evaluating Omicampton-Macarbo and CK586, now called Eulacampton, respectively. Each trial addresses a different form of advanced heart failure, and these programs are central to our mission of delivering new medicines to patients suffering from diseases of cardiac muscle dysfunction, and also addressing the high unmet needs in heart failure as we progress our specialty cardiology franchise forward. In summary, in the past quarter, we made important progress across regulatory, commercial readiness, and also clinical development priorities, and we're building momentum as we approach important milestones expected to occur in the second half of 2025. With that, I'll turn the call over to Andrew, please.