Approval Triggers Milestone Payment of $7.5 Million from Sanofi; Cytokinetics Eligible to Receive Additional Milestone Payments and Royalties on Net Sales in Greater China SOUTH SAN FRANCISCO, Calif., Dec. 17, 2025 (GLOBE NEWSWIRE) — Cytokinetics, Incorporated (Nasdaq: CYTK) today announced that MYQORZO® (aficamten) has been approved by the China National Medical Products Administration (NMPA) for the treatment of adults with New York Heart Association (NYHA) class II-III obstructive hypertrophic cardiomyopathy (oHCM), to improve exercise capacity and symptoms. Under the terms of its license and collaboration agreement with Cytokinetics, Sanofi has exclusive rights to develop and commercialize MYQORZO for the treatment of patients with obstructive and non-obstructive hypertrophic cardiomyopathy (HCM) in Greater China. The approval of MYQORZO in oHCM in China triggers a $7.5 million milestone payment from Sanofi to Cytokinetics. Cytokinetics remains eligible to receive up to $142.5 million in development and commercial milestone payments from Sanofi as well as royalties in the low-to-high teens on future sales of MYQORZO in Greater China. MYQORZO is only approved for use in China. Aficamten is currently under regulatory review in the U.S, where the FDA is reviewing a New Drug Application (NDA) for aficamten with a Prescription Drug User Fee Act (PDUFA) target action date of December 26, 2025. On December 12, 2025 the Committee for Medicinal Products for Human Use (CHMP) of the EMA adopted a positive opinion recommending marketing authorization in the European Union (EU) for aficamten, and a final decision is anticipated from the European Commission in the first quarter of 2026. About MYQORZO® (aficamten) MYQORZO® (aficamten) is an investigational selective, small molecule cardiac myosin inhibitor discovered following an extensive chemical optimization program that was conducted with careful attention to therapeutic index and pharmacokinetic properties.1 MYQORZO was designed to reduce the number of active actin-myosin cross bridges during each cardiac cycle and consequently suppress the myocardial hypercontractility that is associated with HCM. In preclinical models, MYQORZO reduced myocardial contractility by binding directly to cardiac myosin at a distinct and selective allosteric binding site, thereby preventing myosin from entering a force producing state. The development program for MYQORZO is assessing its potential as a treatment that improves exercise capacity as measured by peak oxygen uptake (pVO2) and relieves symptoms in patients with HCM. MYQORZO was evaluated in SEQUOIA-HCM, a positive pivotal Phase 3 clinical trial in patients symptomatic obstructive hypertrophic cardiomyopathy (HCM). MYQORZO received Breakthrough Therapy Designation for the treatment of symptomatic HCM from the U.S. Food & Drug Administration (FDA) and for the treatment of symptomatic obstructive HCM from the National Medical Products Administration (NMPA) in China. Aficamten is also currently under clinical investigation in ACACIA-HCM, a Phase 3 trial in patients with non-obstructive HCM and CEDAR-HCM, in a pediatric population with oHCM. Aficamten has not been deemed safe or effective for use in either of these patient populations. In addition, aficamten is being studied in FOREST-HCM, an open-label extension clinical study. About Hypertrophic Cardiomyopathy Hypertrophic cardiomyopathy (HCM) is a disease in which the heart muscle (myocardium) becomes abnormally thick (hypertrophied). The thickening of cardiac muscle leads to the inside of the left ventricle becoming smaller and stiffer, and thus the ventricle becomes less able to relax and fill with blood. This ultimately limits the heart’s pumping function, resulting in reduced exercise capacity and symptoms including chest pain, dizziness, shortness of breath, or fainting during physical activity. HCM is the most common monogenic inherited cardiovascular disorder, with approximately 280,000 patients diagnosed, however, there are an estimated 400,000-800,000 additional patients who remain undiagnosed in the U.S.2,3,4 Two-thirds of patients with HCM have obstructive HCM (oHCM), where the thickening of the cardiac muscle leads to left ventricular outflow tract (LVOT) obstruction, while one-third have non-obstructive HCM (nHCM), where blood flow isn’t impacted, but the heart muscle is still thickened. People with HCM are at high risk of also developing cardiovascular complications including atrial fibrillation, stroke and mitral valve disease.5 People with HCM are at risk for potentially fatal ventricular arrhythmias and it is one of the leading causes of sudden cardiac death in younger people or athletes.6 A subset of patients with HCM are at high risk of progressive disease leading to dilated cardiomyopathy and heart failure necessitating cardiac transplantation. About Cytokinetics Cytokinetics is a specialty cardiovascular biopharmaceutical company building on its over 25-years of pioneering scientific innovation in muscle biology, and advancing a pipeline of potential new medicines for patients suffering from diseases of cardiac muscle dysfunction with intention to create a muscle biology franchise business focused on medicines designed to optimize muscle performance for patients with cardiac and other diseases of muscle dysfunction. MYQORZO® (aficamten), the company’s cardiac myosin inhibitor, is approved for the treatment of patients with obstructive hypertrophic cardiomyopathy (HCM) in China, and under regulatory review in the U.S. The Committee for Medicinal Products for Human Use of the European Medicines Agency adopted a positive opinion recommending marketing authorization in the European Union for aficamten, and a final decision is anticipated from the European Commission in the first quarter of 2026. Cytokinetics is also developing omecamtiv mecarbil, a cardiac myosin activator, in patients with heart failure with severely reduced ejection fraction, ulacamten, a cardiac myosin inhibitor with a mechanism of action distinct from aficamten, for the potential treatment of heart failure with preserved ejection fraction and CK-089, a fast skeletal muscle troponin activator with potential therapeutic application to a specific type of muscular dystrophy and other conditions of impaired skeletal muscle function. For additional information about Cytokinetics, visit www.cytokinetics.com and follow us on X, LinkedIn, Facebook and YouTube. About the Sanofi and Cytokinetics Collaboration In 2024, Sanofi acquired exclusive rights to develop and commercialize MYQORZO® (aficamten) from Corxel Pharmaceuticals (CORXEL) for the treatment of patients with obstructive and non-obstructive hypertrophic cardiomyopathy (HCM) in Greater China. Previously, CORXEL acquired the rights to develop and commercialize MYQORZO in Greater China from Cytokinetics in accordance with Cytokinetics’ global registration programs. Forward-Looking Statements This press release contains forward-looking statements for purposes of the Private Securities Litigation Reform Act of 1995 (the “Act”). Cytokinetics claims the protection of the Act’s Safe Harbor for forward-looking statements. Examples of such statements include, but not limited to, statements, express or implied, relating to our or our partners’ research and development and commercial readiness activities, our receipt of regulatory approval by FDA or any other regulatory authority to enable our commercialization of aficamten in the United States or any other jurisdiction by any date, if ever, or our earning or receiving any milestone payments or specific quantum of royalties from commercialization of MYQORZO in Greater China. Such statements are based on management’s current expectations, but actual results may differ materially due to various risks and uncertainties, including, but not limited to, the commercialization activities of Sanofi, the actions of regulatory activities, and the results of our on-going clinical trials. For further information regarding these and other risks related to Cytokinetics’ business, investors should consult Cytokinetics’ filings with the Securities and Exchange Commission, particularly under the caption “Risk Factors” in Cytokinetics’ Quarterly Report on Form 10-Q for the quarter ended September 30, 2025. Forward-looking statements are not guarantees of future performance, and Cytokinetics’ actual results of operations, financial condition and liquidity, and the development of the industry in which it operates, may differ materially from the forward-looking statements contained in this press release. Any forward-looking statements that Cytokinetics makes in this press release speak only as of the date of this press release. Cytokinetics assumes no obligation to update its forward-looking statements whether as a result of new information, future events or otherwise, after the date of this press release. CYTOKINETICS® and the CYTOKINETICS C-shaped logo are registered trademarks of Cytokinetics in the U.S. and certain other countries. MYQORZO® is a registered trademark of Cytokinetics in China. References: Chuang C, Collibee S, Ashcraft L, et al. Discovery of Aficamten (CK-274), a Next-Generation Cardiac Myosin Inhibitor for the Treatment of Hypertrophic Cardiomyopathy. J Med Chem. 2021;64(19):14142–14152. https://doi.org/10.1021/acs.jmedchem.1c01290CVrg: Heart Failure 2020-2029, p 44; Maron et al. 2013 DOI: 10.1016/S0140-6736(12)60397-3; Maron et al 2018 10.1056/NEJMra1710575Symphony Health 2016-2021 Patient Claims Data DoF;Maron MS, Hellawell JL, Lucove JC, Farzaneh-Far R, Olivotto I. Occurrence of Clinically Diagnosed Hypertrophic Cardiomyopathy in the United States. Am J Cardiol. 2016; 15;117(10):1651-1654.Gersh, B.J., Maron, B.J., Bonow, R.O., Dearani, J.A., Fifer, M.A., Link, M.S., et al. 2011 ACCF/AHA guidelines for the diagnosis and treatment of hypertrophic cardiomyopathy. A report of the American College of Cardiology Foundation/American Heart Association Task Force on practice guidelines. Journal of the American College of Cardiology and Circulation, 58, e212-260.Hong Y, Su WW, Li X. Risk factors of sudden cardiac death in hypertrophic cardiomyopathy. Current Opinion in Cardiology. 2022 Jan 1;37(1):15-21 Contact:Cytokinetics Diane WeiserSenior Vice President, Corporate Affairs(415) 290-7757
Tag: Cytokinetics
Cytokinetics Announces Positive CHMP Opinion of MYQORZO® (Aficamten) for the Treatment of Obstructive Hypertrophic Cardiomyopathy
Final Decision from European Commission Expected in Q1 2026 SOUTH SAN FRANCISCO, Calif., Dec. 12, 2025 (GLOBE NEWSWIRE) — Cytokinetics, Incorporated (Nasdaq: CYTK) today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion recommending marketing authorization in the European Union (EU) for MYQORZO® (aficamten), a cardiac myosin inhibitor, for the treatment of symptomatic (New York Heart Association, NYHA, class II-III) obstructive hypertrophic cardiomyopathy (oHCM) in adult patients. A final decision is anticipated from the European Commission in the first quarter of 2026. “We are pleased with CHMP’s positive recommendation based on the robust clinical evidence from SEQUOIA-HCM that demonstrated the safety and efficacy of MYQORZO in patients with oHCM, and we are accelerating commercial readiness activities accordingly,” said Robert I. Blum, Cytokinetics’ President and Chief Executive Officer. “Given the urgency to bring new treatment options to the European oHCM patient community, pending the final European Commission decision, we look forward to making MYQORZO available to patients in Europe.” “This positive opinion from the CHMP is an important milestone toward bringing a new treatment option with distinct attributes to patients with oHCM,” said Iacopo Olivotto, M.D., Head of the Cardiomyopathy Center and Professor of Cardiovascular Medicine at the University of Florence, Italy. Aficamten is currently under regulatory review in the U.S., where the Food & Drug Administration (FDA) is reviewing a New Drug Application (NDA) with a Prescription Drug User Fee Act (PDUFA) target action date of December 26, 2025. Additionally, the Center for Drug Evaluation (CDE) of the China National Medical Products Administration (NMPA) is reviewing an NDA for aficamten with Priority Review. About SEQUOIA-HCM The CHMP recommendation for MYQORZO is based on the positive results from the pivotal Phase 3 clinical trial, SEQUOIA-HCM, published in the New England Journal of Medicine, which demonstrated robust efficacy, safety, and clinically meaningful benefits across symptoms, exercise capacity, hemodynamics, and biomarker endpoints.1 The results from SEQUOIA-HCM showed that treatment with MYQORZO for 24 weeks significantly improved exercise capacity compared to placebo, increasing peak oxygen uptake (pVO2) measured by cardiopulmonary exercise testing (CPET) by 1.8 ml/kg/min compared to baseline in patients treated with MYQORZO versus 0.0 ml/kg/min in patients treated with placebo (least square mean (LSM) difference [95% CI] of 1.74 mL/kg/min [1.04 – 2.44]; p=0.000002). The treatment effect of MYQORZO was consistent across all prespecified subgroups, including age, sex, patient baseline characteristics, and in patients receiving or not receiving background beta-blocker therapy. MYQORZO was well-tolerated, with no instances of worsening heart failure or treatment interruptions due to low left ventricular ejection fraction (LVEF). Treatment emergent serious adverse events occurred in 5.6% and 9.3% of patients on MYQORZO and placebo, respectively. Core lab echocardiographic LVEF was observed to be
Cytokinetics Presents Additional Data from MAPLE-HCM at the Hypertrophic Cardiomyopathy Medical Society Scientific Sessions and American Heart Association Scientific Sessions 2025
Three Late Breaking Science Presentations from MAPLE-HCM Provide Additional Data Including Responder Analyses, Patient Reported Outcomes, and Cardiac Biomarkers SOUTH SAN FRANCISCO, Calif., Nov. 10, 2025 (GLOBE NEWSWIRE) — Cytokinetics, Incorporated (Nasdaq: CYTK) today announced that additional data from MAPLE-HCM (Metoprolol vs Aficamten in Patients with LVOT Obstruction on Exercise Capacity in HCM) were presented in three Late Breaking Science sessions at the Hypertrophic Cardiomyopathy Medical Society Scientific Sessions and the American Heart Association Scientific Sessions 2025 in New Orleans, LA. Two of the presentations were simultaneously published in the Journal of the American College of Cardiology.1,2 “These additional analyses from MAPLE-HCM expand on the primary finding that aficamten is superior to metoprolol on exercise capacity, with new insights into the overall treatment effect of aficamten as well as its effect on symptoms and biomarkers in comparison to metoprolol,” said Fady I. Malik, M.D., Ph.D., Cytokinetics’ Executive Vice President of Research & Development. “What’s notable is patients treated with aficamten achieved a significantly greater number of clinical response categories compared with metoprolol, and that nearly 40% achieved significant improvements in patient reported symptoms.” Responder Analysis Shows Significantly More Patients on Aficamten Achieved Positive or Complete Response Compared to Metoprolol Andrew Wang, M.D., Cardiologist and Professor of Medicine, Duke University School of Medicine presented a pre-specified responder analysis from MAPLE-HCM evaluating five clinically relevant measures of disease burden: complete hemodynamic response, symptom improvement, cardiac biomarker response, enhanced exercise capacity and favorable cardiac remodeling. These results were also simultaneously published in the Journal of the American College of Cardiology.1 After 24 weeks of treatment, aficamten was associated with greater improvements than metoprolol in all outcome measures (all p
Cytokinetics Announces Call for Proposals for Its Eighth Annual Communications Grant Program
Program to Provide Support of Communications and Outreach for Patient Advocacy Organizations Focused on Cardiovascular Diseases Deadline for Applications is November 3rd, 2025 SOUTH SAN FRANCISCO, Calif., Sept. 24, 2025 (GLOBE NEWSWIRE) — Cytokinetics, Incorporated (Nasdaq: CYTK) today announced a call for proposals for the eighth annual Cytokinetics Communications Grant Program. The program will award five grants to patient advocacy organizations serving the hypertrophic cardiomyopathy (HCM) and heart failure communities. The grants are intended to support increased communications, awareness building and community engagement. “A persistent funding gap for patient advocacy organizations is in the area of communications. Without adequate resources, patients and caregivers may miss out on important resources and information, while organizations struggle to effectively engage their communities, donors and partners,” said Mary Pomerantz, Cytokinetics’ Senior Director of Patient Advocacy and Engagement. “Through our Communications Grant Program, now in its eighth year, we are proud to support innovative, high-impact initiatives that amplify patient voices, strengthen connections and broaden reach.” The Cytokinetics Communications Grant Program supports patient advocacy organizations in expanding their reach, awareness and community engagement by providing resources for new or crucial communications, marketing or outreach initiatives that would otherwise be challenging to implement. Funding from the Cytokinetics Communications Grant Program may help with programming or personnel, depending on each organization’s needs. The recipients of the 2025 Cytokinetics Communications Grants were the AICARM APS (Italian Association of Cardiomyopathies), HeartBrothers Foundation, HeartCharged Corporation, Hypertrophic Cardiomyopathy Association (HCMA) and Stichting Cardiomyopathie Onderzoek Nederland (Foundation Cardiomyopathy Research the Netherlands). Eligible organizations must have nonprofit organization or registered charity status in the United States, Canada, Europe or United Kingdom and serve the patient communities in HCM or heart failure. Organizations applying for the grant are required to submit a proposal outlining communication activities that the funding would support and the potential impact of the funding. Applications will be evaluated by a committee of representatives from Cytokinetics based on the proposal’s alignment with selection criteria. More details can be found at the application portal listed below. Recipients are responsible for providing an outcomes report to Cytokinetics to measure the impact and results of the funding at the end of the year. Applications may now be submitted at https://www.cybergrants.com/Cytokinetics/communications_grant. The deadline to apply is November 3, 2025, and the grant recipients will be announced in January 2026. For more information on the program, including eligibility guidelines, visit https://cytokinetics.com/responsibility/grants-and-giving/. About Cytokinetics Cytokinetics is a specialty cardiovascular biopharmaceutical company, building on its over 25 years of pioneering scientific innovations in muscle biology, and advancing a pipeline of potential new medicines for patients suffering from diseases of cardiac muscle dysfunction. Cytokinetics is readying for potential regulatory approvals and commercialization of aficamten, a cardiac myosin inhibitor, following positive results from SEQUOIA-HCM, the pivotal Phase 3 clinical trial in patients with obstructive hypertrophic cardiomyopathy (HCM). Aficamten is also being evaluated in additional clinical trials enrolling patients with obstructive and non-obstructive HCM. In addition, Cytokinetics is developing omecamtiv mecarbil, a cardiac myosin activator, in patients with heart failure with severely reduced ejection fraction (HFrEF), ulacamten, a cardiac myosin inhibitor with a mechanism of action distinct from aficamten, for the potential treatment of heart failure with preserved ejection fraction (HFpEF) and CK-089, a fast skeletal muscle troponin activator with potential therapeutic application to a specific type of muscular dystrophy and other conditions of impaired skeletal muscle function. For additional information about Cytokinetics, visit www.cytokinetics.com and follow us on X, LinkedIn, Facebook and YouTube. Disclaimer Aficamten, omecamtiv mecarbil, ulacamten and CK-089 are investigational medicines. They have not been approved nor determined to be safe or efficacious for any disease state or any indication by FDA or any other regulatory agency. Forward-Looking Statements This press release contains forward-looking statements for purposes of the Private Securities Litigation Reform Act of 1995 (the “Act”). Cytokinetics disclaims any intent or obligation to update these forward-looking statements and claims the protection of the Act’s Safe Harbor for forward-looking statements. Examples of such statements include, but are not limited to, statements relating to Cytokinetics’ and its partners’ research and development activities of Cytokinetics’ product candidates. Such statements are based on management’s current expectations, but actual results may differ materially due to various risks and uncertainties, including, but not limited to the risks related to Cytokinetics’ business outlines in Cytokinetics’ filings with the Securities and Exchange Commission. Forward-looking statements are not guarantees of future performance, and Cytokinetics’ actual results of operations, financial condition and liquidity, and the development of the industry in which it operates, may differ materially from the forward-looking statements contained in this press release. Any forward-looking statements that Cytokinetics makes in this press release speak only as of the date of this press release. Cytokinetics assumes no obligation to update its forward-looking statements whether as a result of new information, future events or otherwise, after the date of this press release. CYTOKINETICS® and the C-shaped logo are registered trademarks of Cytokinetics in the U.S. and certain other countries. Contact:CytokineticsDiane WeiserSenior Vice President, Corporate Affairs(415) 290-7757
Cytokinetics Announces Pricing of Upsized $650.0 Million Convertible Senior Notes Offering; Refinances a Portion of 2027 Convertible Notes
SOUTH SAN FRANCISCO, Calif., Sept. 16, 2025 (GLOBE NEWSWIRE) — Cytokinetics, Incorporated (“Cytokinetics”) (Nasdaq: CYTK) today announced the pricing of its offering of $650.0 million aggregate principal amount of 1.75% convertible senior notes due 2031 in a private placement (the “offering”) to persons reasonably believed to be qualified institutional buyers pursuant to Rule 144A under the Securities Act of 1933, as amended (the “Securities Act”). The aggregate principal amount of the offering was increased from the previously announced offering size of $550.0 million. Key elements of the transaction include: Primarily a refinancing transaction of the 3.50% convertible senior notes due 2027 (the “2027 notes”), which extends the maturity of the refinanced debt to 2031Achieved a lower coupon of 1.75% and a higher conversion price of approximately $68.42 compared to the 2027 notesRetiring approximately $399.5 million of the 2027 notesAny remaining proceeds will be used to support the potential commercial launch of aficamten and for general corporate purposes, including potentially to retire the remaining 2027 notes before or at maturity of those notes that are not exchanged and refinanced pursuant to this transaction The issuance and sale of the notes are scheduled to settle on September 19, 2025, subject to customary closing conditions. Cytokinetics also granted the initial purchasers of the notes an option to purchase, for settlement within a period of 13 days from, and including, the date the notes are first issued, up to an additional $100.0 million aggregate principal amount of notes. The notes will be senior, unsecured obligations of Cytokinetics. The notes will accrue interest at an annual rate of 1.75%, payable semi-annually in arrears on April 1 and October 1 of each year, beginning on April 1, 2026. The notes will mature on October 1, 2031, unless earlier converted, redeemed or repurchased by Cytokinetics. Before July 1, 2031, noteholders will have the right to convert their notes only in certain circumstances. From and after July 1, 2031, noteholders may convert all or any portion of their notes at any time at their election until the close of business on the second scheduled trading day immediately before the maturity date. Cytokinetics will settle conversions by paying or delivering, as applicable, cash, shares of its common stock or a combination of cash and shares of its common stock, at Cytokinetics’ election. The initial conversion rate is 14.6156 shares of common stock per $1,000 principal amount of notes, which represents an initial conversion price of approximately $68.42 per share of common stock. The initial conversion price represents a premium of approximately 37.5% over the last reported sale price of $49.76 per share of Cytokinetics’ common stock on September 16, 2025. The conversion rate and conversion price will be subject to adjustment upon the occurrence of certain events. Cytokinetics’ may not redeem the notes at its election at any time before October 6, 2028. The notes will be redeemable, in whole or in part (subject to certain limitations), at Cytokinetics’ option at any time, and from time to time, on a redemption date on or after October 6, 2028 and, in the case of any partial redemption, on or before the 40th scheduled trading day immediately before the maturity date, at a cash redemption price equal to the principal amount of the notes to be redeemed, plus accrued and unpaid interest, if any, to, but excluding, the redemption date, but only if (i) the notes are “freely tradable” (as defined in the indenture for the notes) as of the date Cytokinetics sends the related redemption notice and all accrued and unpaid additional interest, if any, has been paid in full as of the first interest payment date occurring on or before the date such notice is sent and (ii) the last reported sale price per share of Cytokinetics’ common stock exceeds 130% of the conversion price for a specified period of time. If a “fundamental change” (as defined in the indenture for the notes) occurs, then, subject to a limited exception, noteholders may require Cytokinetics to repurchase their notes at a cash repurchase price equal to the principal amount of the notes to be repurchased, plus accrued and unpaid interest, if any, to, but excluding, the fundamental change repurchase date. Use of Proceeds: Cytokinetics estimates that the net proceeds from the offering will be approximately $632.0 million (or approximately $729.4 million if the initial purchasers fully exercise their option to purchase additional notes), after deducting the initial purchasers’ discounts and commissions and Cytokinetics’ estimated offering expenses. Cytokinetics intends to use: approximately $402.5 million of the net proceeds from the offering to pay the cash portion of the consideration in the note exchange transactions as described below; andthe remainder of the net proceeds of this offering will be used (a) to support the potential commercial launch of aficamten, (b) to continue and expand the development program for aficamten, (c) to advance its development and research pipeline, and (d) for general corporate purposes, including potentially to retire the remaining 2027 notes before or at maturity of those notes that are not exchanged and refinanced pursuant to this transaction and working capital. Cytokinetics expects to use approximately $402.5 million of the net proceeds from the offering and to issue 2,168,806 shares of its common stock in exchange for approximately $399.5 million aggregate principal amount of the 2027 notes in privately negotiated transactions (each, a “note exchange transaction”) entered into concurrently with the pricing of the offering. The terms of each note exchange transaction will depend on a variety of factors, including the market price of Cytokinetics’ common stock and the trading price of the 2027 notes at the time of such note exchange transactions. No assurance can be given as to how much, if any, of the 2027 notes will be exchanged or the terms on which they will be exchanged. This press release is not an offer to exchange the 2027 notes, and the offering of the notes is not contingent upon the note exchange transactions. In connection with any note exchange transaction, Cytokinetics expects that holders of the 2027 notes who agree to have their 2027 notes exchanged and who have hedged their equity price risk with respect to such 2027 notes (the “hedged holders”) will, concurrently with, or shortly after, the pricing of the notes, unwind all or part of their hedge positions by buying Cytokinetics’ common stock and/or entering into or unwinding various derivative transactions with respect to its common stock. The amount of Cytokinetics’ common stock to be purchased by the hedged holders or the notional number of shares of Cytokinetics’ common stock underlying such derivative transactions may be substantial in relation to the historic average daily trading volume of Cytokinetics’ common stock. This activity by the hedged holders could increase (or reduce the size of any decrease in) the market price of Cytokinetics’ common stock, including concurrently with the pricing of the notes, resulting in a higher effective conversion price for the notes. Cytokinetics cannot predict the magnitude of such market activity or the overall effect it will have on the price of the notes or its common stock. The offer and sale of the notes, any shares of common stock issuable upon conversion of the notes and any shares of common stock issuable in connection with any note exchange transaction have not been, and will not be, registered under the Securities Act, any state securities laws or the securities laws of any other jurisdiction, and unless so registered, may not be offered or sold in the United States absent registration or an applicable exemption from, or in a transaction not subject to, the registration requirements of the Securities Act and other applicable securities laws. This press release is neither an offer to sell nor a solicitation of an offer to buy any of these securities nor shall there be any sale of these securities in any state or jurisdiction in which such an offer, solicitation or sale would be unlawful prior to the registration or qualification thereof under the securities laws of any state or jurisdiction. About Cytokinetics Cytokinetics is a specialty cardiovascular biopharmaceutical company, building on its over 25 years of pioneering scientific innovations in muscle biology to advance a pipeline of potential new medicines for patients suffering from diseases of cardiac muscle dysfunction. Cytokinetics is readying for potential regulatory approvals and commercialization of aficamten, a cardiac myosin inhibitor following positive results from SEQUOIA-HCM, the pivotal Phase 3 clinical trial in patients with obstructive hypertrophic cardiomyopathy (HCM). Aficamten is also being evaluated in additional clinical trials enrolling patients with obstructive and non-obstructive HCM. Cytokinetics is also developing omecamtiv mecarbil, a cardiac myosin activator, in patients with heart failure with severely reduced ejection fraction (HFrEF), ulacamten, a cardiac myosin inhibitor with a mechanism of action distinct from aficamten, for the potential treatment of heart failure with preserved ejection fraction (HFpEF) and CK-089, a fast skeletal muscle troponin activator with potential therapeutic application to a specific type of muscular dystrophy and other conditions of impaired skeletal muscle function. Forward-Looking Statements This press release includes forward-looking statements within the meaning of Section 27A of the Securities Act and Section 21E of the Securities Exchange Act of 1934, as amended, including statements regarding the completion of the offering, the expected amount and intended use of the net proceeds and the timing or amount of any exchanges of the 2027 notes by Cytokinetics and the potential impact of the foregoing or related transactions on the market price of Cytokinetics’ common stock or the price of the notes. Forward-looking statements represent Cytokinetics’ current expectations regarding future events and are subject to known and unknown risks and uncertainties that could cause actual results to differ materially from those implied by the forward-looking statements. Among those risks and uncertainties are market conditions, the satisfaction of the closing conditions related to the offering and risks relating to Cytokinetics’ business, including in its Annual Report on Form 10-K for the period ended December 31, 2024, filed with the SEC on February 27, 2025 and Quarterly Reports on Form 10-Q for the periods ended March 31, 2025 and June 30, 2025, filed with the SEC on May 6, 2025 and August 7, 2025, respectively, and other filings that Cytokinetics makes from time to time with the SEC. Cytokinetics may not consummate the offering or the note exchange transactions described in this press release and, if the offering is consummated, cannot provide any assurances regarding its ability to effectively apply the net proceeds as described above. The forward-looking statements included in this press release speak only as of the date of this press release, and Cytokinetics does not undertake to update the statements included in this press release for subsequent developments, except as may be required by law. Contact:Cytokinetics, Inc.Diane WeiserSenior Vice President, Corporate Affairs(650) 624-3060
Cytokinetics Announces Primary Results from MAPLE-HCM Presented at the European Society of Cardiology Congress 2025 and Published in The New England Journal Of Medicine
Positive Trial Demonstrates Superiority of Aficamten to Standard-of-Care Beta-Blocker Metoprolol Primary Endpoint Result Consistent Across All Prespecified Subgroups Company to Host Investor Event and Webcast Tuesday September 2, 2025, at 8:00 AM Eastern Time SOUTH SAN FRANCISCO, Calif., Aug. 30, 2025 (GLOBE NEWSWIRE) — Cytokinetics, Incorporated (Nasdaq: CYTK) today announced that primary results from MAPLE-HCM (Metoprolol vs Aficamten in Patients with LVOT Obstruction on Exercise Capacity in HCM) were presented in a Hot Line Session at the European Society of Cardiology Congress 2025 in Madrid, Spain, and simultaneously published in The New England Journal of Medicine.1 MAPLE-HCM is a Phase 3 randomized, double-blind, active-comparator clinical trial of aficamten compared to metoprolol in patients with symptomatic obstructive hypertrophic cardiomyopathy (oHCM). MAPLE-HCM enrolled 175 patients, randomized on a 1:1 basis to receive aficamten or metoprolol as monotherapy. Compared to SEQUOIA-HCM, the pivotal Phase 3 clinical trial of aficamten, MAPLE-HCM was designed to include patients with less severe oHCM, enrolling patients without obstruction at rest and with higher predicted peak oxygen uptake (pVO2). “This important study has the potential to inform our approach to treating obstructive HCM, as MAPLE-HCM provides the field its first look at a cardiac myosin inhibitor compared directly to a beta-blocker,” said Pablo Garcia-Pavia, M.D., Ph.D., Head of the Inherited Cardiac Diseases and Heart Failure Unit, Department of Cardiology, Hospital Universitario Puerta de Hierro and Full Professor, Centro Nacional de Investigaciones Cardiovasculares in Madrid, Spain. “In showing that aficamten is superior to metoprolol on all clinically relevant efficacy endpoints, these results call into question the reliance on beta-blockers as the initial treatment modality for obstructive HCM that has prevailed for over 60 years.” “These results demonstrate that aficamten meaningfully improves exercise capacity in patients with obstructive HCM while treatment with metoprolol resulted in a meaningful reduction in exercise capacity,” said Fady I. Malik, M.D., Ph.D., Cytokinetics’ Executive Vice President of Research & Development. “The clinical difference in the two treatments is reinforced by the effect of aficamten on the secondary endpoints. Compared to first-line standard-of-care metoprolol, treatment with aficamten had a larger effect on measures of symptoms, functional class, and LVOT gradients. Importantly, these effects were achieved in a broader patient population with oHCM than previously studied in SEQUOIA-HCM, inclusive of patients in MAPLE-HCM with less severe disease as measured by objective metrics of disease burden.” Aficamten is an investigational drug candidate currently under regulatory review in the U.S; the Food and Drug Administration (FDA) is reviewing a New Drug Application (NDA) for aficamten with a Prescription Drug User Fee Act (PDUFA) target action date of December 26, 2025. Results of MAPLE-HCM The primary endpoint in MAPLE-HCM was the mean change from baseline in pVO2 for aficamten compared to metoprolol after 24 weeks of treatment. For aficamten, the mean change in pVO2 from baseline to Week 24 was +1.1 mL/kg/min (95% CI 0.5 to 1.7) and for metoprolol was -1.2 mL/kg/min (95% CI -1.7 to -0.8). The primary endpoint was statistically significant with a least-squares mean (LSM) difference between groups of 2.3 mL/kg/min (95% CI 1.5 to 3.1; p
Cytokinetics Names Jim Daly to Board of Directors
SOUTH SAN FRANCISCO, Calif., Aug. 20, 2025 (GLOBE NEWSWIRE) — Cytokinetics, Incorporated (Nasdaq: CYTK) today announced the appointment of James M. Daly to its Board of Directors effective August 19, 2025. Mr. Daly brings over 30 years of global biopharmaceutical leadership experience with particular expertise in commercialization to the Company’s Board of Directors. “Jim has longstanding expertise leading commercial launches of innovative therapies, coupled with extensive Board experience guiding later-stage, global biopharma companies,” said Robert I. Blum, Cytokinetics’ President and Chief Executive Officer. “We are pleased to welcome him to our Board and look forward to his contributions and oversight as our company advances toward becoming a fully integrated commercial organization.” Most recently, Mr. Daly served as the Chief Commercial Officer at Incyte Corporation where he led the launch of Jakafi® (ruxolitinib) and oversaw development of the company’s global commercial capabilities. Previously, he spent 10 years at Amgen where he held multiple senior leadership positions, including Senior Vice President of North America Commercial Operations, and launched several successful medicines including Neulasta®, Xgeva®, Nplate® and Vectibix®. He began his career at GlaxoSmithKline, serving in escalating positions of seniority over his 16-year tenure with the company. He earned a B.S. in Pharmacy and an M.B.A. from the University at Buffalo, SUNY. Mr. Daly currently serves on the Boards of Madrigal Pharmaceuticals, argenx SE, and Acadia Pharmaceuticals. About Cytokinetics Cytokinetics is a specialty cardiovascular biopharmaceutical company, building on its over 25 years of pioneering scientific innovations in muscle biology to advance a pipeline of potential new medicines for patients suffering from diseases of cardiac muscle dysfunction. Cytokinetics is readying for potential regulatory approvals and commercialization of aficamten, a cardiac myosin inhibitor following positive results from SEQUOIA-HCM, the pivotal Phase 3 clinical trial in patients with obstructive hypertrophic cardiomyopathy (HCM). Aficamten is also being evaluated in additional clinical trials enrolling patients with obstructive and non-obstructive HCM. Cytokinetics is also developing omecamtiv mecarbil, a cardiac myosin activator, in patients with heart failure with severely reduced ejection fraction (HFrEF), ulacamten, a cardiac myosin inhibitor with a mechanism of action distinct from aficamten, for the potential treatment of heart failure with preserved ejection fraction (HFpEF) and CK-089, a fast skeletal muscle troponin activator with potential therapeutic application to a specific type of muscular dystrophy and other conditions of impaired skeletal muscle function. For additional information about Cytokinetics, visit www.cytokinetics.com and follow us on X, LinkedIn, Facebook and YouTube. Forward-Looking Statements This press release contains forward-looking statements for purposes of the Private Securities Litigation Reform Act of 1995 (the “Act”). Cytokinetics disclaims any intent or obligation to update these forward-looking statements and claims the protection of the Act’s Safe Harbor for forward-looking statements. Examples of such statements include, but are not limited to, statements relating to Cytokinetics’ and its partners’ research and development activities of Cytokinetics’ product candidates. Such statements are based on management’s current expectations, but actual results may differ materially due to various risks and uncertainties, including, but not limited to the risks related to Cytokinetics’ business outlines in Cytokinetics’ filings with the Securities and Exchange Commission. Forward-looking statements are not guarantees of future performance, and Cytokinetics’ actual results of operations, financial condition and liquidity, and the development of the industry in which it operates, may differ materially from the forward-looking statements contained in this press release. Any forward-looking statements that Cytokinetics makes in this press release speak only as of the date of this press release. Cytokinetics assumes no obligation to update its forward-looking statements whether as a result of new information, future events or otherwise, after the date of this press release. CYTOKINETICS® and the CYTOKINETICS and C-shaped logo are registered trademarks of Cytokinetics in the U.S. and certain other countries. Contact:Cytokinetics Diane WeiserSenior Vice President, Corporate Affairs(415) 290-7757
Cytokinetics Reports Second Quarter 2025 Financial Results and Provides Business Update
Regulatory Reviews of Aficamten for Obstructive HCM Progressing in U.S., E.U. and China; Late-Cycle Meeting with U.S. FDA Scheduled for September Ahead of December 26, 2025 PDUFA Date Primary Results from MAPLE-HCM to be Presented in a Hot Line Session at the European Society of Cardiology Congress 2025 ~$1.0 Billion in Cash, Cash Equivalents and Investments as of June 30, 2025 SOUTH SAN FRANCISCO, Calif., Aug. 07, 2025 (GLOBE NEWSWIRE) — Cytokinetics, Incorporated (Nasdaq: CYTK) reported a management update and financial results for the second quarter of 2025. “Following solid progress in the first half of the year, we are looking forward to several key corporate milestones. Our primary focus remains on preparations for the potential FDA approval of aficamten in late December and subsequent commercial launch in early 2026,” said Robert I. Blum, Cytokinetics’ President and Chief Executive Officer. “Additionally, we are pleased to be sharing results from MAPLE-HCM later this month, which we believe will provide important information related to the standard-of-care in obstructive HCM. With our current balance sheet and additional access to capital, we are well-positioned to execute on both the commercialization and potential label expansion opportunities of aficamten while also advancing our later-stage specialty cardiovascular pipeline.” Q2 and Recent Highlights Cardiac Muscle Programs aficamten (cardiac myosin inhibitor) Continued to support the review of the New Drug Application (NDA) for aficamten for the treatment of patients with obstructive hypertrophic cardiomyopathy (HCM) by the U.S. Food and Drug Administration (FDA). With the three-month extension of the Prescription Drug User Fee Act (PDUFA) target action date to December 26, 2025, the late cycle meeting is now scheduled to occur in September.Prepared responses to the Day 120 List of Questions from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) regarding the Marketing Authorization Application (MAA) for aficamten for the treatment of obstructive HCM; submission on track to meet the clock stop timeline agreed with EMA. We expect a potential EMA decision regarding the MAA in 1H 2026.Completed all Good Clinical Practice (GCP) inspections for applications under review.Continued to support the review of the NDA for aficamten for obstructive HCM by the Center for Drug Evaluation (CDE) in China. Advanced the ongoing clinical trials program for aficamten: Announced positive topline results from MAPLE-HCM (Metoprolol vs Aficamten in Patients with LVOT Obstruction on Exercise Capacity in HCM). The primary results will be presented in a Hot Line Session in August at the European Society of Cardiology Congress 2025.Continued conduct of ACACIA-HCM (Assessment Comparing Aficamten to Placebo on Cardiac Endpoints In Adults with Non-Obstructive HCM), a pivotal Phase 3 clinical trial of aficamten in patients with non-obstructive HCM. We expect to share topline results of the primary cohort (excluding Japan) in 1H 2026. Dosed the first patient in the Japan cohort of ACACIA-HCM. Dosed the first patient in CAMELLIA-HCM, a Phase 3 clinical trial of aficamten in Japanese patients with obstructive HCM. CAMELLIA-HCM is being conducted by Bayer in collaboration with Cytokinetics to support potential marketing authorization in Japan.Continued enrolling patients in CEDAR-HCM (Clinical Evaluation of Dosing with Aficamten to Reduce Obstruction in a Pediatric Population in HCM), a clinical trial of aficamten in a pediatric population with symptomatic obstructive HCM. We expect to complete patient enrollment of the adolescent cohort in 2H 2025. Presented new analyses at the European Society of Cardiology Heart Failure 2025 Congress from SEQUOIA-HCM on the effect of aficamten between patients with mild and moderate-to-severe symptoms, and across geographic regions. Expanded U.S. commercial readiness activities for aficamten including sales force recruitment, final stages of implementing patient support programs and finalization of our promotional launch campaign. Continued payer engagement to educate on the clinical data supportive of aficamten and the clinical and economic burden of HCM.Advanced European commercial readiness activities including hiring key leadership positions in our European headquarters and other EU and UK geographies, preparing Health Technology Assessment (HTA) dossiers and ensuring launch readiness for potential approval in Germany in 1H 2025. Published the following manuscripts: “A Plain Language Summary of the SEQUOIA-HCM Study: Aficamten for Symptomatic Obstructive Hypertrophic Cardiomyopathy” in Future Cardiology“Efficacy of Aficamten in Patients with Obstructive Hypertrophic Cardiomyopathy and Mild Symptoms: Results from the SEQUOIA-HCM Trial” in the European Heart Journal“Associations of Sex on Economic Burden in Patients with Symptomatic Obstructive Hypertrophic Cardiomyopathy: Results from Medical and Pharmacy Claims Data in Frontiers in Cardiovascular Medicine“Aficamten Treatment for Symptomatic Obstructive Hypertrophic Cardiomyopathy: 48-weeks Results From FOREST-HCM” in the Journal of the American College of Cardiology – Heart Failure“Concomitant Aficamten and Disopyramide in Symptomatic Obstructive Hypertrophic Cardiomyopathy” in the Journal of the American College of Cardiology – Heart Failure“Clinical Evaluation of the Effect of Aficamten on QT/QTc Interval in Healthy Participants” in Clinical and Translational Science omecamtiv mecarbil (cardiac myosin activator) Continued conduct of COMET-HF (Confirmation of Omecamtiv Mecarbil Efficacy Trial in Heart Failure), a confirmatory Phase 3 clinical trial of omecamtiv mecarbil in patients with symptomatic heart failure with severely reduced ejection fraction. We expect to continue enrollment through 2025 to enable completion of enrollment in late 2026. ulacamten (CK-4021586, cardiac myosin inhibitor) Received approval from the International Nonproprietary Names (INN) Program of the World Health Organization for ulacamten to be used as the nonproprietary name for CK-4021586.Continued conduct of AMBER-HFpEF (Assessment of CK-586 in a Multi-Center, Blinded Evaluation of Safety and Tolerability Results in HFpEF), a Phase 2 clinical trial of ulacamten in patients with symptomatic heart failure with preserved ejection fraction (HFpEF) with left ventricular ejection fraction (LVEF) ≥ 60%. We expect to complete patient enrollment of the first two cohorts in 2H 2025. Pre-Clinical Development and Ongoing Research Continued pre-clinical development and research activities directed to additional muscle biology focused programs. Second Quarter 2025 Financial Results Cash, Cash Equivalents and Investments As of June 30, 2025, the company had approximately $1.0 billion in cash, cash equivalents and investments compared to $1.1 billion at March 31, 2025. Cash, cash equivalents and investments declined by $52.6 million during the second quarter of 2025. The Company received $75 million in proceeds from the drawing on Tranche 4 of the Royalty Pharma Multi Tranche Term Loan in the second quarter of 2025. Revenues Total revenues for the second quarter of 2025 were $66.8 million compared to $0.2 million for the same period in 2024. Revenues in the second quarter of 2025 included the recognition of $52.4 million related to the Company’s license and collaboration agreement for aficamten in Japan with Bayer, and $11.7 million for the achievement of clinical milestones in the non-obstructive HCM and obstructive HCM trials in Japan. Research and Development (R&D) Expenses R&D expenses for the second quarter of 2025 were $112.6 million, which included $13.5 million of non-cash stock-based compensation expense, compared to $79.6 million for the same period in 2024, which included $11.5 million of non-cash stock-based compensation expense. The increase was primarily due to advancing our clinical trials, higher personnel-related costs, and medical affairs-related activities. General and Administrative (G&A) Expenses G&A expenses for the second quarter of 2025 were $65.7 million, which included $14.0 million of non-cash stock-based compensation expense, compared to $50.8 million for the same period in 2024, which included $13.1 million of non-cash stock-based compensation expense. The increase was primarily due to investments toward commercial readiness and higher personnel-related costs. Net Income (Loss) Net loss for the second quarter of 2025 was $134.4 million, or $(1.12) per share, basic and diluted, compared to a net loss of $143.3 million, or $(1.31) per share, basic and diluted, for the same period in 2024. 2025 Financial Guidance The company is maintaining its full year 2025 financial guidance: GAAP operating expense*$670 million to $710 millionNon-cash stock-based compensation expense included in GAAP operating expense$120 million to $110 million *GAAP operating expense comprised of R&D and SG&A expenses. Anticipated year-over-year increase in GAAP operating expense includes investments toward commercial readiness for the potential approval and launch of aficamten for patients with obstructive HCM. The financial guidance does not include the effect of GAAP adjustments as may be caused by events that occur subsequent to publication of this guidance, including but not limited to Business Development activities. Conference Call and Webcast Information Members of Cytokinetics’ senior management team will review the company’s second quarter 2025 results on a conference call today at 4:30 PM Eastern Time. The conference call will be simultaneously webcast and can be accessed from the Investors & Media section of Cytokinetics’ website at www.cytokinetics.com or directly at the following link: Cytokinetics Q2 2025 Earnings Conference Call. An archived replay of the webcast will be available via Cytokinetics’ website for six months. About Cytokinetics Cytokinetics is a specialty cardiovascular biopharmaceutical company, building on its over 25 years of pioneering scientific innovations in muscle biology to advance a pipeline of potential new medicines for patients suffering from diseases of cardiac muscle dysfunction. Cytokinetics is readying for potential regulatory approvals and commercialization of aficamten, a cardiac myosin inhibitor following positive results from SEQUOIA-HCM, the pivotal Phase 3 clinical trial in patients with obstructive hypertrophic cardiomyopathy (HCM). Aficamten is also being evaluated in additional clinical trials enrolling patients with obstructive and non-obstructive HCM. Cytokinetics is also developing omecamtiv mecarbil, a cardiac myosin activator, in patients with heart failure with severely reduced ejection fraction (HFrEF), ulacamten, a cardiac myosin inhibitor with a mechanism of action distinct from aficamten, for the potential treatment of heart failure with preserved ejection fraction (HFpEF) and CK-089, a fast skeletal muscle troponin activator with potential therapeutic application to a specific type of muscular dystrophy and other conditions of impaired skeletal muscle function. For additional information about Cytokinetics, visit www.cytokinetics.com and follow us on X, LinkedIn, Facebook and YouTube. Forward-Looking Statements This press release contains forward-looking statements for purposes of the Private Securities Litigation Reform Act of 1995 (the “Act”). Cytokinetics claims the protection of the Act’s Safe Harbor for forward-looking statements. Examples of such statements include, but not limited to, statements, express or implied, relating to our or our partners’ research and development and commercial readiness activities, including the initiation, conduct, design, enrollment, progress, continuation, completion, timing and results of any of our clinical trials, or more specifically, our receipt of regulatory approval by FDA or any other regulatory authority to enable our commercialization of aficamten in the United States or any other jurisdiction by the target PDUFA date or any other date, if ever, our ability to complete enrollment of CEDAR-HCM and AMBER-HFpEF in the second half of 2025, our ability to complete patient enrollment of COMET-HF in 2026, our ability to announce the results of ACACIA-HCM in the first half of 2026, our ability to announce the results of any of our clinical trials by any particular date, the timing of interactions with FDA or any other regulatory authorities in connection to any of our drug candidates and the outcomes of such interactions; statements relating to the potential patient population who could benefit from aficamten, omecamtiv mecarbil, CK-586, CK-089 or any of our other drug candidates; statements relating to our ability to receive additional capital or other funding, including, but not limited to, our ability to meet any of the conditions relating to or to otherwise secure additional loan disbursements under any of our agreements with entities affiliated with Royalty Pharma or additional milestone payments from Sanofi or Bayer in connection with our collaborations for aficamten in China or Japan respectively; statements relating to our operating expenses or cash utilization for the remainder of 2025 or any other period, and statements relating to our cash balance at any particular date or the amount of cash runway such cash balances represent at any particular time. Such statements are based on management’s current expectations, but actual results may differ materially due to various risks and uncertainties, including, but not limited to Cytokinetics’ need for additional funding and such additional funding may not be available on acceptable terms, if at all; potential difficulties or delays in the development, testing, regulatory approvals for trial commencement, progression or product sale or manufacturing, or production of Cytokinetics’ drug candidates that could slow or prevent clinical development or product approval; patient enrollment for or conduct of clinical trials may be difficult or delayed; the FDA or foreign regulatory agencies may delay or limit Cytokinetics’ or its partners’ ability to conduct clinical trials; Cytokinetics may incur unanticipated research and development and other costs; standards of care may change, rendering Cytokinetics’ drug candidates obsolete; and competitive products or alternative therapies may be developed by others for the treatment of indications Cytokinetics’ drug candidates and potential drug candidates may target. For further information regarding these and other risks related to Cytokinetics’ business, investors should consult Cytokinetics’ filings with the Securities and Exchange Commission, particularly under the caption “Risk Factors” in Cytokinetics’ Quarterly Report on Form 10-A for the quarter ended March 31, 2025. Forward-looking statements are not guarantees of future performance, and Cytokinetics’ actual results of operations, financial condition and liquidity, and the development of the industry in which it operates, may differ materially from the forward-looking statements contained in this press release. Any forward-looking statements that Cytokinetics makes in this press release speak only as of the date of this press release. Cytokinetics assumes no obligation to update its forward-looking statements whether as a result of new information, future events or otherwise, after the date of this press release. CYTOKINETICS® and the CYTOKINETICS and C-shaped logo are registered trademarks of Cytokinetics in the U.S. and certain other countries. Contact:Cytokinetics Diane WeiserSenior Vice President, Corporate Affairs(415) 290-7757 Cytokinetics, IncorporatedCondensed Consolidated Balance Sheets(in thousands) June 30, 2025 December 31, 2024 (unaudited) ASSETS Current assets: Cash and short term investments $858,135 $1,076,014 Other current assets 28,407 31,926 Total current assets 886,542 1,107,940 Long-term investments 178,201 145,055 Property and equipment, net 70,219 65,815 Operating lease right-of-use assets 76,120 75,158 Other assets 14,553 7,705 Total assets $1,225,635 $1,401,673 LIABILITIES AND STOCKHOLDERS’ DEFICIT Current liabilities: Accounts payable and accrued liabilities $68,543 $75,692 Short-term operating lease liabilities 19,585 18,978 Current portion of long-term debt 14,400 11,520 Derivative liabilities measured at fair value 17,600 11,300 Deferred revenue 1,344 52,370 Other current liabilities 9,592 9,814 Total current liabilities 131,064 179,674 Term loan, net 159,058 93,227 Convertible notes, net 553,987 552,370 Liabilities related to revenue participation right purchase agreements, net 489,503 462,192 Long-term operating lease liabilities 111,028 112,582 Liabilities related to RPI Transactions measured at fair value 147,700 137,000 Other non-current liabilities 2,015 — Total liabilities 1,594,355 1,537,045 Commitments and contingencies Stockholders’ deficit Common stock 119 118 Additional paid-in capital 2,628,829 2,563,876 Accumulated other comprehensive (loss) income (158) 2,398 Accumulated deficit (2,997,510) (2,701,764)Total stockholders’ deficit (368,720) (135,372)Total liabilities and stockholders’ deficit $1,225,635 $1,401,673 Cytokinetics, IncorporatedCondensed Consolidated Statements of Operations(in thousands except per share data)(unaudited) Three Months Ended Six Months Ended June 30, 2025 June 30, 2024 June 30, 2025 June 30, 2024Revenues: Collaboration revenues $2,416 $249 $3,995 $1,084 License and milestone revenues 64,353 — 64,353 — Total revenues 66,769 249 68,348 1,084 Operating expenses: Research and development 112,554 79,597 212,395 161,167 General and administrative 65,721 50,824 123,090 96,324 Total operating expenses 178,275 130,421 335,485 257,491 Operating loss (111,506) (130,172) (267,137) (256,407)Interest expense (11,084) (12,732) (19,952) (19,835)Non-cash interest expense on liabilities related to revenue participation right purchase agreements (13,181) (11,567) (27,259) (21,785)Interest and other income, net 13,001 11,553 26,702 19,466 Change in fair value of derivative liabilities 3,000 (600) 2,600 (600)Change in fair value of liabilities related to RPI Transactions (14,600) 200 (10,700) 200 Net loss $(134,370) $(143,318) $(295,746) $(278,961)Net loss per share — basic and diluted $(1.12) $(1.31) $(2.49) $(2.63)Weighted-average number of shares used in computing net loss per share — basic and diluted 119,457 109,240 118,979 106,013
Cytokinetics Announces Positive Topline Results From MAPLE-HCM
Trial Demonstrates Superiority of Aficamten to Standard of Care Beta Blocker in Improving Peak Exercise Capacity in Patients with Obstructive Hypertrophic Cardiomyopathy SOUTH SAN FRANCISCO, Calif., May 13, 2025 (GLOBE NEWSWIRE) — Cytokinetics, Incorporated (Nasdaq: CYTK) today announced positive topline results from MAPLE-HCM (Metoprolol vs Aficamten in Patients with LVOT Obstruction on Exercise Capacity in HCM), a Phase 3 clinical trial comparing aficamten as monotherapy to the standard of care beta blocker metoprolol as monotherapy in patients with symptomatic obstructive hypertrophic cardiomyopathy (HCM). MAPLE-HCM met its primary endpoint, demonstrating a statistically significant improvement in peak oxygen uptake (pVO2) from baseline to Week 24 for aficamten compared to metoprolol. The safety and tolerability profile of aficamten was favorable in comparison to metoprolol in MAPLE-HCM. The full results from MAPLE-HCM will be presented at an upcoming medical conference. “These results represent the first evidence that aficamten may be used as monotherapy to deliver clinically meaningful improvements in people living with obstructive hypertrophic cardiomyopathy,” said Fady I. Malik, M.D., Ph.D., Cytokinetics’ Executive Vice President of Research & Development. “Importantly, the results from MAPLE-HCM provide important context to the benefit of this potential new medicine compared to the current standard of care. We are grateful to the investigators, site personnel and patients who participated in MAPLE-HCM, and look forward to presenting the full results at an upcoming medical meeting.” MAPLE-HCM: Clinical Trial Design MAPLE-HCM was a Phase 3, multi-center, randomized, double-blind active-comparator clinical trial of aficamten compared to metoprolol in patients with symptomatic obstructive HCM. The primary endpoint was the change in peak oxygen uptake (pVO2) from baseline to Week 24 measured by cardiopulmonary exercise testing (CPET). Secondary endpoints include the change from baseline to Week 24 in Kansas City Cardiomyopathy Questionnaire (KCCQ) score, the proportion of patients with ≥1 class improvement in New York Heart Association (NYHA) functional class, and changes in left ventricular mass index (LVMI), left atrial volume index (LAVI), post-Valsalva left ventricular outflow tract gradient (LVOT-G) and NT-proBNP. MAPLE-HCM enrolled 175 patients, randomized on a 1:1 basis to receive aficamten or metoprolol as monotherapy in a double-blind, double dummy fashion. Randomization was stratified by CPET exercise modality (treadmill or bicycle) and recently diagnosed versus chronic obstructive HCM. At screening, patients enrolled in MAPLE-HCM had a resting LVOT-G ≥30 mmHg and/or post-Valsalva LVOT-G ≥50 mmHg in addition to left ventricular ejection fraction (LVEF) ≥ 60%, respiratory exchange ratio (RER) ≥ 1.05 and pVO2
Cytokinetics Announces New PDUFA Date for Aficamten in Obstructive Hypertrophic Cardiomyopathy
SOUTH SAN FRANCISCO, Calif., May 01, 2025 (GLOBE NEWSWIRE) — Cytokinetics, Incorporated (Nasdaq: CYTK) today announced that the U.S. Food and Drug Administration (FDA) has extended the Prescription Drug User Fee Act (PDUFA) action date for the New Drug Application (NDA) for aficamten for the treatment of patients with obstructive hypertrophic cardiomyopathy (oHCM) to December 26, 2025. The FDA recently notified Cytokinetics that additional time is required to conduct a full review of the company’s proposed Risk Evaluation and Mitigation Strategy (REMS). Following pre-NDA discussions with FDA in which safety and risk mitigation were discussed, Cytokinetics submitted the NDA for aficamten in oHCM without an accompanying REMS, and the FDA accepted the NDA for filing. Recently, during the NDA review, the FDA requested that Cytokinetics submit a REMS, based on the inherent characteristics of aficamten, which the company provided. The submission of a REMS has now been determined by FDA to be a Major Amendment to the NDA resulting in a standard three-month extension to the original PDUFA action date. No additional clinical data or studies have been requested of Cytokinetics by FDA. “We remain confident in the distinct benefit-risk and pharmaceutic profile of aficamten and continue to expect a differentiated label and risk mitigation profile upon its potential approval by FDA,” said Robert I. Blum, Cytokinetics’ President and Chief Executive Officer. “We look forward to continuing our constructive engagement with the FDA regarding the NDA for aficamten.” About Cytokinetics Cytokinetics is a specialty cardiovascular biopharmaceutical company, building on its over 25 years of pioneering scientific innovations in muscle biology to advance a pipeline of potential new medicines for patients suffering from diseases of cardiac muscle dysfunction. Cytokinetics is readying for potential regulatory approvals and commercialization of aficamten, a cardiac myosin inhibitor following positive results from SEQUOIA-HCM, the pivotal Phase 3 clinical trial in patients with obstructive hypertrophic cardiomyopathy (HCM). Aficamten is also being evaluated in additional clinical trials enrolling patients with obstructive and non-obstructive HCM. Cytokinetics is also developing omecamtiv mecarbil, a cardiac myosin activator, in patients with heart failure with severely reduced ejection fraction (HFrEF), CK-586, a cardiac myosin inhibitor with a mechanism of action distinct from aficamten, for the potential treatment of heart failure with preserved ejection fraction (HFpEF) and CK-089, a fast skeletal muscle troponin activator with potential therapeutic application to a specific type of muscular dystrophy and other conditions of impaired skeletal muscle function. For additional information about Cytokinetics, visit www.cytokinetics.com and follow us on X, LinkedIn, Facebook and YouTube. Forward-Looking Statements This press release contains forward-looking statements for purposes of the Private Securities Litigation Reform Act of 1995 (the “Act”). Cytokinetics claims the protection of the Act’s Safe Harbor for forward-looking statements. Examples of such statements include, but not limited to, statements, express or implied, relating to our receipt of regulatory approval by FDA or any other regulatory authority to enable our commercialization of aficamten in the United States or any other jurisdiction by the target PDUFA date or any other date, if ever, and statements regarding our expectation that aficamten will be approved with a differentiated label and REMS. Such statements are based on management’s current expectations, but actual results may differ materially due to various risks and uncertainties, including FDA’s on-going review of our NDA for aficamten in obstructive hypertrophic cardiomyopathy. For further information regarding these and other risks related to Cytokinetics’ business, investors should consult Cytokinetics’ filings with the Securities and Exchange Commission, particularly under the caption “Risk Factors” in Cytokinetics’ Annual Report on Form 10-K for the year ended December 31, 2024. Any forward-looking statements that Cytokinetics makes in this press release speak only as of the date of this press release. Cytokinetics assumes no obligation to update its forward-looking statements whether as a result of new information, future events or otherwise, after the date of this press release. CYTOKINETICS® and the CYTOKINETICS and C-shaped logo are registered trademarks of Cytokinetics in the U.S. and certain other countries. Contact:Cytokinetics Diane WeiserSenior Vice President, Corporate Affairs(415) 290-7757



