SOUTH SAN FRANCISCO, Calif., March 31, 2025 (GLOBE NEWSWIRE) -- Cytokinetics, Incorporated (Nasdaq: CYTK) today announced that members of the Company's management team are scheduled to participate in a fireside chat at the 24 Annual Needham Virtual Healthcare Conference on Monday, April 7, 2025 at 2:15 PM Eastern Time. Interested parties may access the live webcast of the fireside chat by visiting the Investors & Media section of the Cytokinetics website at http://www.cytokinetics.com. The webcast replay wi ...

Cytokinetics (CYTK) shares rallied 5.4% in the last trading session to close at $45.43. This move can be attributable to notable volume with a higher number of shares being traded than in a typical session. This compares to the stock's 15.7% loss over the past four weeks.The company has made good pipeline progress of late. Lead candidate aficamten is under review in the United States for the treatment of obstructive hypertrophic cardiomyopathy. Other pipeline candidates are also advancing well.This biopharm ...

Interactive Tool Harnesses Real-World Data to Visualize Burden of Disease in HCM and Advance Equitable Access to Care SOUTH SAN FRANCISCO, Calif., March 20, 2025 (GLOBE NEWSWIRE) --  Cytokinetics, Incorporated (NASDAQ:CYTK) today announced the launch of EARTH-HCM (Epidemiology, Awareness, Real-world Treatment and Health Outcomes in HCM), an online, open access, interactive public health education tool developed by Cytokinetics in collaboration with leading academic institutions, that leverages real-world, d ...

New Analyses Related to Aficamten Expand on its Metabolism Pathways,Treatment Effect Associated with Combination Therapy with Disopyramideand Longer-Term Effect on Cardiac Structure and Function SOUTH SAN FRANCISCO, Calif., March 17, 2025 (GLOBE NEWSWIRE) -- Cytokinetics, Incorporated (Nasdaq: CYTK) today announced five presentations related to aficamten, an investigational cardiac myosin inhibitor, and hypertrophic cardiomyopathy (HCM), at the American College of Cardiology (ACC) Annual Scientific Session ...

Company Overview - Cytokinetics, Incorporated (NASDAQ: CYTK) is a clinical-stage biopharmaceutical company focused on developing therapies for heart failure, neuromuscular disorders, and hypertrophic cardiomyopathy (HCM) [1] Commercialization Progress - The company is rapidly advancing towards the commercialization phase of its drug Aficamten, indicating a significant shift from clinical development to market readiness [1]

Core Viewpoint - Cytokinetics reported a wider net loss per share in Q4 2024 compared to estimates, while revenues fell short of expectations despite a significant year-over-year increase [1][3]. Financial Performance - The company reported a net loss of $1.26 per share in Q4 2024, compared to a loss of $1.38 per share in the same quarter last year [1] - Revenues totaled $16.9 million, missing the Zacks Consensus Estimate of $20 million, but up from $1.7 million in the year-ago quarter [3] - R&D expenses increased by 10.2% year-over-year to $93.6 million, driven by clinical trial advancements and higher personnel costs [6] - General and administrative expenses surged 41.3% to $62.3 million due to investments in commercial readiness and personnel-related expenses [6] - As of December 31, 2024, the company had approximately $1.2 billion in cash, cash equivalents, and investments [6] Product Development and Regulatory Progress - The FDA accepted the new drug application (NDA) for aficamten, with a target action date of September 26, 2025 [7] - The European Medicines Agency (EMA) validated the Marketing Authorization Application (MAA) for aficamten, with a review expected to yield questions by April [9] - Aficamten is being evaluated in multiple clinical trials, including MAPLE-HCM and ACACIA-HCM [13] Collaborations and Licensing Agreements - Cytokinetics entered a collaboration agreement with Bayer for aficamten in Japan, including an upfront payment of €50 million and potential milestone payments totaling €90 million [10][11] - Sanofi acquired exclusive rights for aficamten in Greater China, with Cytokinetics eligible for up to $150 million in milestone payments and royalties on future sales [11][12] Pipeline Candidates - Other pipeline candidates include omecamtiv mecarbil, currently in a phase III trial for heart failure [14] - The company initiated AMBER-HFpEF, a phase II trial for CK-586 in heart failure patients, and a phase I study for CK-089 [15]

Financial Data and Key Metrics Changes - The company reported revenues of $16.9 million for Q4 2024, a significant increase from $1.7 million in Q4 2023, and full-year revenues of $18.5 million compared to $7.5 million in 2023 [47] - R&D expenses for Q4 2024 were $93.6 million, up from $85 million in Q4 2023, while full-year R&D expenses were $339.4 million compared to $330.1 million in 2023 [48] - G&A expenses for Q4 2024 were $62.3 million, compared to $44.1 million in Q4 2023, with full-year G&A expenses at $215.3 million versus $173.6 million in 2023 [49] - The net loss for Q4 2024 was $150 million or $1.26 per share, compared to a net loss of $136.9 million or $1.38 per share in Q4 2023, with a full-year net loss of $589.5 million or $5.26 per share compared to $526.2 million or $5.45 per share in 2023 [50] Business Line Data and Key Metrics Changes - The company is advancing its clinical trials for aficamten, with ongoing studies including MAPLE-HCM, ACACIA-HCM, and CEDAR-HCM, which are expected to provide opportunities for label expansion [13][27] - The launch preparations for aficamten are well underway, focusing on increasing market awareness and category penetration for cardiac myosin inhibitors [17][20] Market Data and Key Metrics Changes - The company noted a growing opportunity for aficamten to capture a largely untapped market, with an increase in the number of patients treated with cardiac myosin inhibitors [17] - The company is expanding its commercial launch activities in international markets, particularly in Europe, to support potential approvals [21] Company Strategy and Development Direction - The company aims to commercialize aficamten in the U.S. and Western Europe, while also partnering with Sanofi and Bayer for development in China and Japan, respectively [12][31] - The strategic focus includes advancing the specialty cardiology franchise and expanding the R&D pipeline through external collaborations [36][37] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the potential U.S. approval and commercial launch of aficamten in 2025, highlighting the importance of regulatory interactions and market readiness [7][53] - The company anticipates significant growth in operating expenses due to investments in commercial readiness for aficamten's launch [51] Other Important Information - The company has a strong balance sheet with approximately $1.2 billion in cash and investments, down from $1.3 billion at the end of Q3 2024 [46] - The company is preparing for a mid-cycle meeting with the FDA and expects to share top-line results from MAPLE-HCM in Q2 2025 [9][59] Q&A Session Summary Question: Timeline for potential label expansion if MAPLE-HCM results are positive - Management expects label expansion to occur in 2026, depending on the timing of the results and other factors [64] Question: Expectations for diagnosis rates of HCM over the next 3-5 years - Management estimates that the diagnosis rate could increase to around 50% in the next 3-5 years, driven by increased awareness and education [76][78] Question: Thoughts on the upcoming Edgewise dataset - Management refrained from commenting on another company's program but expressed confidence in aficamten's safety and efficacy data [85][87] Question: Expectations for mavacamten's REMS and its impact on aficamten - Management noted that they are monitoring the situation and believe aficamten will have a differentiated profile if approved [94][98] Question: Education around aficamten's drug interaction profile - Management indicated that physicians are aware of aficamten's favorable drug interaction profile and do not anticipate a need for extensive monitoring [106][108] Question: Endpoints for ACACIA trial and comparisons to competitors - Management explained that ACACIA is designed with both KCCQ and exercise endpoints, focusing on consistency across functional and symptomatic measures [115]

Financial Position - As of December 31, 2024, the company's cash and investments totaled $1,221.1 million, including U.S. Treasury securities and corporate debt[290]. - The total assets increased to $1.4 billion as of December 31, 2024, compared to $824.3 million in 2023[310]. - Cash and cash equivalents decreased to $94.9 million as of December 31, 2024, from $113.0 million in 2023[310]. - The total stockholders' deficit improved to $(135.4) million as of December 31, 2024, from $(386.3) million in 2023[310]. - The company has an accumulated deficit of approximately $2.7 billion since inception[323]. - The company believes existing cash and investments will be sufficient to fund cash requirements for at least the next 12 months[325]. Revenue and Expenses - Total revenues for the year ended December 31, 2024, were $18.5 million, a significant increase from $7.5 million in 2023[312]. - Research and development expenses for 2024 were $339.4 million, slightly up from $330.1 million in 2023[312]. - The net loss for the year ended December 31, 2024, was $589.5 million, compared to a net loss of $526.2 million in 2023[312]. - The company incurred net cash used in operations of $395.9 million for the year ended December 31, 2024, compared to $414.3 million in 2023[319]. - The company reported stock-based compensation expense of $97.8 million for 2024, compared to $72.1 million in 2023[319]. Liabilities and Debt - The company recognized a loss of approximately $19.6 million in 2024 due to changes in the estimated fair value of liabilities[292]. - As of December 31, 2024, the liabilities related to revenue participation right purchase agreements were $462.2 million, with a non-cash interest expense of $(48.8) million recognized for the year[303]. - The carrying value of liabilities related to RPI transactions measured at fair value was $137.0 million as of December 31, 2024[308]. - The company has entered into revenue participation right purchase agreements, which are accounted for as liabilities to be amortized over the life of the related royalty stream, reflecting ongoing financial obligations[348]. - The company anticipates future minimum payments of $227.5 million under the RP OM Loan Agreement based on the specified repayment scenarios[374]. Market Risks - The company is exposed to market risks primarily related to interest rate sensitivities[289]. - A hypothetical 1% increase in market interest rates would result in a decline in the value of investments by approximately $6.1 million as of December 31, 2024[291]. - The fair value of certain liabilities will increase as market interest rates decrease, potentially affecting future earnings[292]. - The discount rates for the liabilities ranged from 10% to 18% as of December 31, 2024, compared to 14% to 18% as of June 30, 2024[292]. Stock and Equity - The company closed a public offering of 9,803,922 shares at $51.00 per share, generating gross proceeds of approximately $575.0 million[439]. - The company issued 5,016,170 shares for net proceeds of $164.2 million under the Amended ATM Facility in 2023[448]. - The total grant-date fair value of options to purchase common stock vested was $57.5 million in 2024[442]. - As of December 31, 2024, the balance of outstanding stock options was 10,419,523 with a weighted average exercise price of $31.84[442]. - Stock-based compensation expense for 2024 was $97.84 million, up from $72.07 million in 2023 and $47.85 million in 2022, with research and development accounting for $44.01 million in 2024[455]. Future Outlook - The company anticipates continued operating losses and net cash outflows in future periods[323]. - The earliest expected commercial sales and revenue recognition is in 2025, following the NDA filing for aficamten in September 2024[324]. - The company plans to fund operations through strategic collaborations, equity sales, grants, and debt financing until achieving profitable operations[324]. - The company expects to fulfill the technology transfer related to the Bayer License Agreement in the first half of 2025[416]. Taxation - The company did not record an income tax provision in 2024, 2023, and 2022 due to net taxable losses[468]. - As of December 31, 2024, federal net operating loss carryforwards were $1,195.2 million, with state NOL carryforwards of $428.2 million[472]. - The valuation allowance on net deferred tax assets increased by $140.4 million in 2024 and $128.6 million in 2023[471]. - The company expects no material impact from the Inflation Reduction Act of 2022 on its consolidated tax provision for the year ending December 31, 2024[477].

Financial Performance - Total revenues for Q4 2024 were $16.9 million, a significant increase from $1.7 million in Q4 2023, and total revenues for the full year 2024 were $18.5 million compared to $7.5 million in 2023[20]. - Total revenues for the year ended December 31, 2024, were $18.4 million, a significant increase from $7.53 million in 2023, representing a growth of approximately 144%[35]. - License and milestone revenues for Q4 2024 reached $15 million, compared to $1 million in Q4 2023, indicating a 1400% increase[35]. - The net loss for Q4 2024 was $150.0 million, or $(1.26) per share, compared to a net loss of $136.9 million, or $(1.38) per share, in Q4 2023[23]. - The company reported a net loss of $589.5 million for the year ended December 31, 2024, compared to a net loss of $526.2 million in 2023, representing an increase in losses of approximately 12%[35]. Expenses - R&D expenses for Q4 2024 were $93.6 million, up from $85.0 million in Q4 2023, with full year R&D expenses totaling $339.4 million compared to $330.1 million in 2023[21]. - G&A expenses for Q4 2024 were $62.3 million, compared to $44.1 million in Q4 2023, with full year G&A expenses reaching $215.3 million versus $173.6 million in 2023[22]. Cash and Investments - As of December 31, 2024, the company had approximately $1.2 billion in cash, cash equivalents, and investments, a decrease of approximately $60 million from $1.3 billion at September 30, 2024[17]. - Cash and short-term investments as of December 31, 2024, totaled $1,076.0 million, up from $614.8 million at the end of 2023, marking a 75% increase[33]. Assets and Liabilities - Total assets increased to $1,401.7 million as of December 31, 2024, compared to $824.3 million in 2023, reflecting a growth of approximately 70%[33]. - Total liabilities rose to $1,537.0 million as of December 31, 2024, compared to $1,210.6 million in 2023, indicating an increase of about 27%[33]. - The company’s accumulated deficit increased to $2,701.8 million as of December 31, 2024, from $2,112.2 million in 2023, representing a rise of approximately 28%[33]. Strategic Initiatives - The company announced financial guidance for 2025, projecting GAAP operating expenses between $670 million and $710 million, which includes investments toward commercial readiness for aficamten[25]. - The FDA accepted the NDA for aficamten with a PDUFA target action date of September 26, 2025, and the company is preparing for a potential commercial launch in 2H 2025[4][11]. - The company entered into a collaboration and license agreement with Bayer for the exclusive development and commercialization of aficamten in Japan, receiving a payment of $52.4 million (€50 million) for this agreement[19]. - The company expects to report topline results from the MAPLE-HCM trial in Q2 2025 and aims to complete patient enrollment for the ACACIA-HCM trial in 2H 2025[18]. - The company aims to complete enrollment of clinical trials ACACIA-HCM, CEDAR-HCM, and AMBER-HFpEF in the second half of 2025[30]. - Future interactions with the FDA regarding drug candidates are anticipated, with a focus on regulatory approvals to enable commercialization of aficamten[30]. Vision and Goals - The company is advancing its Vision 2030 strategic objectives to become a leading muscle-focused specialty biopharmaceutical company[13].

Core Insights - Cytokinetics is preparing for the commercial launch of aficamten, a cardiac myosin inhibitor, with regulatory submissions under review in the U.S., Europe, and China, targeting a PDUFA date of September 26, 2025 [1][3][10] - The company reported significant progress in clinical trials and financial guidance for 2025, indicating a strong balance sheet with approximately $1.2 billion in cash and investments as of December 31, 2024 [1][14][21] Regulatory and Clinical Developments - The FDA accepted the New Drug Application (NDA) for aficamten, which is intended for the treatment of obstructive hypertrophic cardiomyopathy (HCM), with a standard review process underway [3][10] - The European Medicines Agency (EMA) validated the Marketing Authorization Application (MAA) for aficamten, and the China National Medical Products Administration (NMPA) accepted the NDA for priority review [3][10] - Ongoing clinical trials include MAPLE-HCM, ACACIA-HCM, and CEDAR-HCM, with topline results from MAPLE-HCM expected in Q2 2025 [3][9][10] Financial Performance - Total revenues for Q4 2024 were $16.9 million, a significant increase from $1.7 million in Q4 2023, driven by a $15 million upfront payment from Bayer for aficamten's development rights in Japan [15][20] - R&D expenses for Q4 2024 were $93.6 million, reflecting increased investment in clinical trials, while G&A expenses rose to $62.3 million due to commercial readiness efforts [18][19] - The net loss for Q4 2024 was $150 million, or $(1.26) per share, compared to a net loss of $136.9 million, or $(1.38) per share, in Q4 2023 [20][32] Strategic Initiatives - The company aims to advance its go-to-market strategies for aficamten in the U.S. and Europe, with plans to coordinate with Sanofi for potential approval in China [16][21] - Cytokinetics has outlined its Vision 2030 strategic objectives to enhance its position as a leading muscle-focused biopharmaceutical company [16][25] - The company is also developing additional drug candidates, including omecamtiv mecarbil and CK-586, targeting various heart failure conditions [25]