SOUTH SAN FRANCISCO, Calif., Jan. 29, 2024 (GLOBE NEWSWIRE) -- Cytokinetics, Incorporated (NASDAQ:CYTK) today announced the recipients of its sixth annual Communications Grant Program, intended to support increased capacity in communications, awareness building and community engagement. Five grants in the amount of $20,000 each were awarded this year to patient advocacy organizations focused on the hypertrophic cardiomyopathy (HCM), heart failure and amyotrophic lateral sclerosis (ALS) communities. The gran ...

SOUTH SAN FRANCISCO, Calif., Jan. 25, 2024 (GLOBE NEWSWIRE) -- Cytokinetics, Incorporated (NASDAQ:CYTK) today announced new data at CMR 2024 demonstrating favorable effects on cardiac structure, function and fibrosis related to treatment with aficamten in FOREST-HCM (Follow-up, Open-Label, Research Evaluation of Sustained Treatment with Aficamten in HCM), the open label extension clinical trial of aficamten in patients with hypertrophic cardiomyopathy (HCM). In many patients with HCM, the left ventricular h ...

Cytokinetics, Incorporated (NASDAQ:CYTK) Q3 2023 Earnings Conference Call November 2, 2023 4:30 PM ET Company Participants Diane Weiser - Senior Vice President of Corporate Communications & Investor Relations Robert Blum - President & Chief Executive Officer Fady Malik - Executive Vice President, Research & Development Stuart Kupfer - Vice President & Chief Medical Officer Andrew Callos - EVP & Chief Commercial Officer Robert Wong - Vice President & Chief Accounting Officer Ching Jaw - Senior Vice President ...

Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended September 30, 2023 or ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission file number: 000-50633 CYTOKINETICS, INCORPORATED (Exact name of registrant as specified in its charter) Delaware 94-32913 ...

Financial Data and Key Metrics Changes - The company ended the second quarter with $592.6 million in cash and investments, representing nearly two years of cash runway based on revised spending guidance [27][53] - General and administrative expenses decreased to $39.7 million in Q2 2023 from $42.7 million in Q2 2022, primarily due to reduced outsourced spending [28] - R&D expenses increased to $83.2 million in Q2 2023 from $57.1 million in Q2 2022, mainly due to increased spending on the cardiac myosin inhibition program [52] Business Line Data and Key Metrics Changes - Enrollment in the SEQUOIA-HCM trial was completed with 282 patients randomized, surpassing the target of 270 patients, making it the largest randomized clinical trial for obstructive HCM [8][15] - The company announced the start of patient enrollment in the MAPLE-HCM trial, with the first patients recently randomized [11] - The Acacia HCM trial is expected to open for patient enrollment next month, ahead of schedule, indicating strong enthusiasm for this trial [22] Market Data and Key Metrics Changes - The company is focusing on the U.S. and European markets for the potential approval and commercialization of aficamten, with plans to hire key personnel in Europe [26] - Market research indicates a large unaddressed population of patients with obstructive HCM that may benefit from aficamten if approved [25] Company Strategy and Development Direction - The company has reduced operating spending by approximately 15% relative to initial 2023 financial guidance, focusing on priorities and pipeline [16] - The strategic planning process includes evaluating corporate and pipeline scenarios, contingencies, and risk mitigations to inform investment decisions [30] - The company aims to file 1 to 2 additional INDs for new drug candidates over the next 1 to 2 years, expanding its pipeline according to Vision 2025 goals [57] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in achieving goals for the rest of the year, supported by a stronger financial foundation and ongoing research [7] - The company is optimistic about the potential of aficamten in nonobstructive HCM and looks forward to starting the Phase III clinical trial soon [10] - Management highlighted the importance of evidence from clinical trials to inform treatment guidelines and payer acceptance [68] Other Important Information - The company is actively engaged in business development initiatives in Japan and Europe, seeking potential partners for omecamtiv mecarbil and aficamten [32] - The company participated in a Type A meeting with the FDA regarding the CRL for omecamtiv mecarbil, continuing to support reviews in Europe and China [56] Q&A Session Summary Question: What gives confidence in CK-586's mechanism of action for patients? - Management indicated that CK-586 is intentionally being advanced as distinct from aficamten, focusing on different disease states [35] Question: Expectations for enrollment rates in the Maple and Acacia trials? - Management stated it is too early to guide on enrollment rates and will provide updates as trials progress [63] Question: Are there specific geographies targeted for clinical trials? - Management confirmed a broad strategy to capture all geographies, with specific considerations for treatment differences in various regions [72] Question: What is the strategic logic behind the sole primary endpoint of KCCQ for Acacia? - Management explained that the decision was based on prior study experiences and aimed to increase the likelihood of success by avoiding composite endpoints [74] Question: How does the company view the current stock price and potential partnerships? - Management emphasized that any potential deal would need to meet expectations and that the company is focused on building its commercial business in Europe [119]

Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended June 30, 2023 or ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission file number: 000-50633 CYTOKINETICS, INCORPORATED (Exact name of registrant as specified in its charter) Delaware 94-3291317 (S ...

Financial Data and Key Metrics Changes - In Q1 2023, R&D expenses increased to $79.4 million from $45.9 million in Q1 2022, primarily due to increased spending on clinical development activities related to cardiac myosin inhibitor programs and COURAGE-ALS [47] - G&A expenses rose to $49.7 million from $33.1 million in Q1 2022, mainly due to higher personnel-related costs, including stock-based compensation and pre-commercial launch readiness expenses [47] - The company ended the quarter with approximately $704 million in cash, representing a two-year cash runway, and expects to reduce overall spending in 2023 by more than 10% [48][20] Business Line Data and Key Metrics Changes - The company is focusing on Aficamten, with over 60% of the R&D budget previously allocated to it, and expects an even higher proportion of total spending to be dedicated to Aficamten in 2023 [10] - Aficamten is anticipated to optimize patient and physician experience through quick and sustained improvement of symptoms, straightforward dose titration, and minimal drug-to-drug interaction [17] Market Data and Key Metrics Changes - The overall prevalence of HCM in the US is estimated to be roughly 700,000 to 1 million, with the diagnosed patient population (both obstructive and non-obstructive HCM) estimated at approximately 290,000, indicating a significant growth opportunity in the undiagnosed population [45] Company Strategy and Development Direction - The company aims to build the industry's leading specialty cardiology business, focusing on a strong R&D pipeline rooted in muscle biology [22] - The strategy includes pursuing potential international approvals for omecamtiv mecarbil and preparing for U.S. commercialization of Aficamten independently [21][9] - The company is also seeking potential partners in Europe and Japan for both omecamtiv mecarbil and Aficamten [49] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the company's position and future prospects, despite challenges faced in 2023 [22] - The company is committed to maximizing shareholder value while focusing on patient needs and advancing its R&D pipeline [52][20] Other Important Information - The company received a complete response letter from the FDA for omecamtiv mecarbil and is planning to meet with the FDA to discuss feedback and options going forward [201] - The COURAGE-ALS study was concluded due to insufficient signals of activity, allowing the company to reallocate resources to Aficamten [202] Q&A Session Summary Question: Confidence in timelines for SEQUOIA results - Management is confident in completing enrollment in SEQUOIA and expects results in Q4 2023, with no anticipated delays into early 2024 [27][56] Question: Commercial launch preparations for Aficamten - The company is monitoring the uptake of cardiac myosin inhibitors and believes the market is evolving as predicted, which does not change their commercialization strategy for Aficamten [28] Question: Enrollment and standard deviation in SEQUOIA - Management confirmed that there is no risk of increasing enrollment and that the standard deviation is within expected parameters [30][84] Question: Regulatory strategy for Aficamten in Europe - The trials being run are expected to fulfill regulatory requirements, with no additional studies anticipated at this time [135] Question: Potential for Aficamten to be positioned ahead of metoprolol - Strong data showing Aficamten's efficacy compared to beta blockers would provide a rationale for its use as first-line therapy [138]

Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended March 31, 2023 or ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission file number: 000-50633 CYTOKINETICS, INCORPORATED (Exact name of registrant as specified in its charter) | Title of each class ...

empowering muscle empowering lives ©2023 CYTOKINETICS, All Rights Reserved. CYTOKINETICS® and the C-shaped logo are registered trademarks of Cytokinetics in the U.S. and certain other countries. Actual pa Chuck, diagnosed with ALS Forward-Looking Statements 2 Not for Promotional Use, For Investors Only O V E R V I E W C A R D I A C M U S C L E S K E L E T A L M U S C L E C O R P O R A T E P R O F I L E Our Mission 3 Build commercial capabilities to market and sell our medicines reflective of their innovatio ...

Cytokinetics, Incorporated (NASDAQ:CYTK) Q4 2022 Earnings Conference Call March 1, 2023 4:30 PM ET Company Participants Diane Weiser - Senior Vice President, Corporate Communications & Investor Relations Robert Blum - President & Chief Executive Officer Fady Malik - Executive Vice President, Research & Development Andrew Callos - Executive Vice President and Chief Commercial Officer Stuart Kupfer - Senior Vice President & Chief Medical Officer Robert Wong - Vice President & Chief Accounting Officer Ching Ja ...