Cytokinetics, Incorporated

and welcome to the Cytokinetics Q3 2025 Earnings Conference Call. This call is being recorded and all participants are in a listen-only 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 that time, simply press the star followed by the number one on your telephone keypad. If you would like to withdraw your question, press star one again once more. I would now like to turn the call over to Diane Wiser, 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 Kalos, 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 and medical affairs activities for Affy Campton. Stuart Kupfer, SVP and Chief Medical Officer, will provide updates on the clinical development program for Omicampton McCarble and Eula Campton. Sung Lee, 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 third 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. Now, I will turn the call over to Robert.

Thank you, Diane, and thanks to all for joining us on the call today. The past quarter was highly productive and defining for cytokinetics. We made significant progress across the company's priority objectives as we advanced towards the end of the year, when we hoped to achieve our first potential FDA approval of Affy-Campden for patients with OHCM. Our major accomplishments this past quarter were dedicated to preparing for that milestone, including continuing constructive engagements with FDA, completing key commercial launch readiness activities, and fortifying our capital structure. During the quarter, we held our late cycle meeting with the FDA. As we previously disclosed during the meeting, we discussed our proposed REMS program, including elements to assure safe use or ETASU, as well as anticipated post-marketing requirements. Prior to the meeting, we had received FDA's responses to our proposed REMS and label for Affy-Campden. And based on our exchanges and discussions with FDA to date, we continue to expect a differentiated label and risk mitigation profile for afecamtin if approved by the FDA. We've completed all GCP inspections by the FDA with no observations noted. Moreover, to date, we have not been notified of the intention of FDA to conduct pre-approval inspections. We look forward to continuing our dialogue with FDA ahead of the PDUFA date. In recent months, we've also leaned further into commercial readiness with the onboarding of our commercial field sales colleagues and the finalization of promotional campaigns and patient support programs with objective to further differentiate how we show up commercially. At the same time, in Q3, we achieved an important clinical milestone within the development program for Affie-Campden. We presented the positive primary results from Maple HCM, which demonstrated superiority of afecamcin to metoprolol in patients with OHCM, challenging the long-held status quo of treatment in this disease. Our intention is to file a supplemental MDA for Maple HCM following its potential initial FDA approval. But in the meantime, we believe these results may help catalyze certain prescribers and help unlock more of the market upon the initial introduction of Afikampton, as may result in increased commercial launch velocity. Following closely behind the potential approval and launch of Afikampton in the United States is the expected potential approval of Afikampton in the EU. During the quarter, we received the day 120 list of questions from the EMA, and we subsequently submitted our responses. More recently, we've continued EMA interactions and we're preparing day 180 responses. We're encouraged by ongoing interactions and we expect a final decision from the European Commission in the first half of next year, even possibly on the earlier side of the year, given the pace of our review to date. In parallel, our European launch readiness activities are well underway, focused on market access planning, medical education and engagement with the cardiology community, and to ensure a strong foundation for a successful introduction of afecamptin in Europe. We also continue to work closely with Sanofi to support the potential approval of afecamptin in China to further broaden the global opportunity and reinforce our commitment to making this therapy available to patients worldwide. To achieve all of this, we're fortunate to have a strong balance sheet which we further bolstered during the quarter through our convertible note offering. As Sung will elaborate, this transaction helped not only to provide additional capital at this important time, but also financial flexibility. And lastly, we continue to build momentum across our broader pipeline at this important inflection point in our corporate development, reflecting our ongoing commitment to sustained innovation and longer-term growth. With that, I'll turn the call over now to Andrew, please.