Cytokinetics, Incorporated

Thank you for standing by and welcome to the Psychokinetics Q2 2026 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 this time, simply press star followed by the number one on your telephone keypad. If you would like to withdraw your question, press star one again. I would now like to turn the call over to Diane Weiser, Cytokinetics Senior Vice President of Corporate Affairs. Diane, please go ahead.

Good afternoon and thanks for joining us on the call today. The slides accompanying today's webcast can be found on the Investors and Media section of our website at cytokinetics.com along with today's press release. Robert Blum, President and Chief Executive Officer, will begin with an overview of the quarter and recent developments. Andrew Callos, EVP and Chief Commercial Officer, will discuss the commercial launch of mycorrhizal in the U.S. and Europe. Fady Malik, EVP of R&D, will provide updates related to AfriCampden. Steve Heitner, SVP and Chief Medical Officer, will provide updates related to our ongoing clinical development programs. Sung Lee, EVP and Chief Financial Officer, will provide a financial overview for the quarter and finally Robert will make closing remarks and review key milestones for the year ahead. As you can see on this slide, today's discussion will include forward looking statements which are subject to risks and uncertainties. Please refer to our SEC filings for discussion of these factors. 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 second quarter was another solid period of execution for cytokinetics. Marked by strong commercial momentum for myCORSO in the United States, our first European launch in Germany, progress towards additional market access globally, potential regulatory milestones internationally, and continued advancement of our later stage specialty cardiology pipeline. Just five months into the commercial launch of myCORSO, we are demonstrating increased velocity that's exceeding expectations. As Andrew will discuss, growth in prescribing and dispensing for mycorso reflects increasing awareness and physician engagement, expanding patient access, and adoption across multiple segments of the targeted prescriber base, all of which reinforce confidence in mycorso and its clinical, therapeutic, and commercial opportunities. During the quarter, we also executed well on our global commercialization strategy with the launch of mycorso in Germany, the first in a series of European launches expected over the next six to 12 months. This is a key milestone for cytokinetics and for patients in Europe, and it serves as the foundation upon which we will build broader access across Europe and beyond over the coming years. To that end, more recently, the MHRA granted mycorso marketing authorization across the United Kingdom. for the treatment of symptomatic OHCM in adult patients. And at the same time, NICE issued guidance recommending mycorzo for use in England and Wales. We're pleased that the concurrent regulatory approval and reimbursement recommendation will help mycorzo reach patients sooner. We expect drug supply and full launch in the UK later this year. During the second quarter, We highlighted the opportunity for Afikampton to potentially treat the full spectrum of HCM. As we shared, the top line results from Acacia HCM in patients with non-obstructive HCM showed that the phase three trial met both of its dual primary endpoints, demonstrating statistically significant improvements from baseline to week 36 in both KCCQ clinical summary score and peak VO2 compared to placebo. These results represent an important scientific achievement for an NHCM patient population with no currently approved therapies and they define a meaningful step toward expanding the potential reach of afecamtin beyond OHCM, subject of course to regulatory review and subsequent potential approval. Following our announcement of the top line results from Acacia HCM, We met with the FDA to discuss our next steps. We reviewed the clinical trial results together and we posed questions to which the FDA responded. Those discussions and the FDA feedback now inform our plan to submit a supplemental NDA for afikampton in NHCM in the fourth quarter of this year. We also plan to meet with EU regulators to hold similar discussions in support of future potential regulatory submissions in Europe. In the meantime, we look forward to presenting the full results from Acacia HCM in a hotline session at the European Society of Cardiology Congress to occur later this month. Alongside progress towards making mycorrhizal available to more patients with OHCM in the United States and internationally, we're prioritizing potential regulatory approvals for Afikampton in patients with NHCM, and as could lead to mycorrhizal being the only approved therapy for patients across the wider spectrum of HCM. Moreover, in the second quarter, as you'll hear, we continue to advance our later stage specialty cardiology pipeline with further progress evidence in important clinical trials for novel drug candidates that have emerged from our pioneering leadership in innovative muscle biology and pharmacology. And we fortified our balance sheet with a successful financing that supports our plans and objectives. Taken all together, the progress we made this second quarter underscores that cytokinetics is executing well on a global commercial stage and integrated biopharmaceutical company. We're building commercial growth and velocity expanding global scale and access proceeding towards expanded product labeling and advancing pipeline all with focus and discipline to capital access and allocation i look forward to sharing more about that now from our colleagues and with that i'll turn the call over to andrew thank you robert in the second quarter the launch of my corso continued to exhibit strong growth