Topline Results from SEQUOIA-HCM Announced in DecemberShowed Statistically Significant and Clinically Meaningful Increasein Primary Efficacy Endpoint and Improvements in All Secondary Endpoints
Company Plans to Submit New Drug Application for Aficamten to FDA in Q3 2024and Marketing Authorization Application to EMA in Q4 2024
Primary Results from SEQUOIA-HCM Are Expectedto be Presented at an Upcoming Medical Conference in Q2 2024
Company Provides 2024 Financial Guidance; Approximately 2 Years of Cash Runway
SOUTH SAN FRANCISCO, Calif., Feb. 27, 2024 (GLOBE NEWSWIRE) -- Cytokinetics, Incorporated (Nasdaq: CYTK) reported financial results for the fourth quarter and full year 2023. Net loss for the fourth quarter was $136.9 million or $1.38 per share and the net loss for the year 2023 was $526.2 million or $5.45 per share. Net loss for the fourth quarter of 2022 was $137.4 million or $1.45 per share and net loss for the year 2022 was $389.0 million or $4.33 per share. Cash, cash equivalents and investments totaled $655.4 million on December 31, 2023. This cash balance does not include approximately $83 million in net proceeds generated in early 2024 from the sale of common stock through an at-the-market equity vehicle.
“We ended 2023 strong with positive results from SEQUOIA-HCM which now propel our company forward to the next stages of planning towards our specialty cardiology business model,” said Robert I. Blum, Cytokinetics’ President and Chief Executive Officer. “As we prepare regulatory submissions for aficamten, we are executing on commercial readiness activities while also conducting Phase 3 clinical trials in patients with oHCM and nHCM which we believe may further generate evidence in support of our next-in-class objectives to reach a broader array of patients struggling with hypertrophic cardiomyopathy. With a strong balance sheet enabling ample cash runway and multiple levers to access capital, we are pleased to be turning the page onto the next chapter for Cytokinetics and all stakeholders.”
Q4 and Recent Highlights
Cardiac Muscle Programs
aficamten (cardiac myosin inhibitor)
- Announced positive results from SEQUOIA-HCM (Safety, Efficacy, and Quantitative Understanding of Obstruction Impact of Aficamten in HCM) in December demonstrating that treatment with aficamten significantly improved exercise capacity compared to placebo, increasing peak oxygen uptake (pVO2) measured by cardiopulmonary exercise testing (CPET) by a least square mean difference (95% CI) of 1.74 (1.04 - 2.44) mL/kg/min (p=0.000002). Statistically significant (p