Cytokinetics, Incorporated

Good afternoon, and welcome, ladies and gentlemen, to Cytokinetics' fourth quarter 2022 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 for questions and answers after the presentation. We will allow for up to one question per participant. I will now turn the call over to Diane Weiser, Cytokinetics' Senior Vice President of Corporate Communications and Investor Relations. 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 corridor and recent developments. Fadi Malek, EVP of R&D, will provide updates related to Omicampton-McCarbell and Affy-Campton, as well as other drug candidates comprising our early clinical development pipeline. Andrew Kalos, EVP and Chief Commercial Officer, will speak further about Omicamp and McCarbell and our specialty cardiology franchise strategy related to Affy Campton. Stuart Kupfer, SVP and Chief Medical Officer, will provide an update on REL Dissentive. Robert Wong, VP and Chief Accounting Officer, will provide a financial overview of the past quarter. And Ching Jha, SVP and Chief Financial Officer, will discuss our 2023 financial guidance and corporate development strategies. Finally, Robert Blum will provide closing comments and review expected key milestones for 2023. 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 fourth quarter 2022 financial results filed on Form 8K and our Form 10K, each of which were filed 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 fourth quarter of 2022 was productive across our pipeline with continued progress being made through the beginning of this year. Beginning with Omicamp to McCarville yesterday, we received a complete response letter from the FDA. The letter communicated that galactic HF is not sufficiently persuasive to establish substantial evidence of effectiveness for reducing the risk of heart failure events and cardiovascular death in adults with chronic heart failure with HF-REF in lieu of evidence from at least two adequate and well-controlled clinical investigations. FDA stated that results from an additional clinical trial of Omicantamacarbonyl are required to establish substantial evidence of effect for the treatment of HF-REF with benefits that outweigh the risks. As we stated in our call this morning, we expect to request a meeting with FDA in order to understand FDA's views regarding the CRL and what may be required to support potential approval of omicamptamicarbo in the United States. However, as mentioned this morning, we have no plans to conduct an additional clinical trial of omicamptamicarbo, and our focus remains on the development program for aficamptam. While disappointing, this is a scenario for which we prepared. As Andrew will elaborate, in anticipation of this potential outcome, a substantial portion of our anticipated 2023 commercial spending and hiring was gated on the potential approval of Omicampton McCarble. Our commercial infrastructure has also been designed and developed with the ability to pivot to focus on Affycampton in line with our specialty cardiovascular franchise strategy. Moreover, and in parallel, as you'll be hearing more from my colleagues, we will continue in 2023 to press forward with regulatory authorities to seek approvals for omicamptomicarbol in other countries and as may provide support to corporate development and business development activities. As mentioned previously, we believe in the science underlying omicamptomicarbol and the demonstrated clinical evidence to potentially benefit patients with advanced and worsening heart failure. With that said, however, we will not bet the company on Omicampton McCarvel, and ours is a broad pipeline on novel muscle biology-directed drug candidates. Cytokinetics is well positioned to press forward with Affycampton as represents our next major opportunity to bring forward an important new medicine to serve patients in need. And to that end, in the fourth quarter, the development program for Affy-Kempton progressed in both obstructive and non-obstructive HCM. As Fadi will explain, we're poised for an important year with data expected from cohort four of Redwood HCM in N-HCM this coming weekend at the ACC Scientific Sessions in New Orleans and results from the pivotal phase three trial Sequoia HCM later this year in Q4. Concurrently, we have plans to substantially expand the development program for Affy-Kempton by beginning two new Phase III clinical trials in 2023, one in OHCM with Affy-Kempton as monotherapy and one in NHCM. As Stuart will elaborate for rel-deceptive, patient enrollment continued to encourage ALS following the first interim analysis that occurred last quarter, and we expect the Data Monitoring Committee to conduct the second interim analysis for the ongoing trial in the second quarter of this year. We believe rel-deceptive can represent an entirely new pharmacology for ALS patients underserved by the lack of a muscle-directed therapy. Entering 2023, Tidal Connects remains on strong financial footing with over two years of forward cash owing to our strategic and gated build of our commercial capabilities, as well as our creative dealmaking and prudent investment spending. We expect our burn rate in 2023 to be within a comparable range to 2022 despite our broadening of the clinical development program for afi campton. As well as our expanding and extending our early clinical development pipeline as you'll also hear more during our call today. And despite the setback for Omicamp to McCarble, our mission remains the same as it has been for 25 years now, to bring forward new medicines for patients with diseases of impaired muscle function, and our convictions run as strong as ever. With that, I'll turn the call over to Fatty.