NEW YORK, Nov. 05, 2025 (GLOBE NEWSWIRE) -- The Gross Law Firm issues the following notice to shareholders of Cytokinetics, Incorporated (NASDAQ: CYTK). Shareholders who purchased shares of CYTK during the class period listed are encouraged to contact the firm regarding possible lead plaintiff appointment. Appointment as lead plaintiff is not required to partake in any recovery. CONTACT US HERE: https://securitiesclasslaw.com/securities/cytokinetics-incorporated-loss-submission-form/?id=175402&from=3 CLASS ...

Financial Data and Key Metrics Changes - The company reported a net loss of $306.2 million, or $2.55 per share, for Q3 2025, compared to a net loss of $160.5 million, or $1.36 per share for the same period in 2024, indicating a significant increase in losses [28][29]. - Cash and investments increased to approximately $1.25 billion at the end of Q3 2025, up from $1 billion at the end of Q2 2025, primarily due to net proceeds from a convertible note offering [27][28]. - R&D expenses rose to $99.2 million in Q3 2025 from $84.6 million in Q3 2024, driven by advancing clinical trials and higher personnel-related costs [28]. Business Line Data and Key Metrics Changes - The company achieved a clinical milestone with Aficamten, presenting positive primary results from the Maple HCM trial, demonstrating superiority over metoprolol in patients with OHCM [6][17]. - Aficamten's commercial readiness activities are progressing, with a focus on onboarding sales teams and finalizing promotional campaigns ahead of the anticipated FDA approval [10][12]. Market Data and Key Metrics Changes - The company is preparing for potential approval of Aficamten in both the U.S. and EU, with expectations for a final decision from the European Commission in the first half of 2026 [8][34]. - The company is also working with Sanofi to support the potential approval of Aficamten in China, broadening its global market opportunity [8]. Company Strategy and Development Direction - The company aims to transition to a fully integrated commercial entity, focusing on regulatory approvals and commercial launch strategies for Aficamten [32][34]. - The strategy includes differentiating Aficamten through its risk mitigation profile and comprehensive patient support services, aiming for parity access by the second half of 2026 [13][34]. Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in achieving a differentiated label and risk mitigation profile for Aficamten, anticipating a strong commercial launch following FDA approval [5][10]. - The company is optimistic about the ongoing interactions with the FDA and EMA, expecting timely approvals that will facilitate market entry [8][34]. Other Important Information - The company welcomed James Daley to its board of directors, bringing extensive biopharma commercial leadership experience [32]. - The company is actively engaging with the HCM community to prepare for the launch of Aficamten, conducting advisory board meetings and institutional visits [22]. Q&A Session Summary Question: What are the expectations regarding the Acacia trial data and its impact on approval? - Management indicated that the trial's success depends on the magnitude of results and safety profile, emphasizing that both endpoints are critical for regulatory evaluation [40][42]. Question: How does the company plan to monitor the launch metrics for Aficamten? - The company plans to share metrics related to prescribing breadth, depth, and patient volume, but will not provide specific targets due to the limited distribution of data [55]. Question: What is the anticipated pricing strategy for Aficamten? - The pricing is expected to be in proximity to Mavacamten, with flexibility based on the product profile [74]. Question: How will the company handle patient conversion to commercial drug post-launch? - The company anticipates a variable timeline for conversion, with potential delays due to payer reviews, but plans to support patients through assistance programs [78].

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, 2025 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 Performance - Total revenues for Q3 2025 were $1.9 million, up from $0.5 million in Q3 2024, representing a 280% increase[12] - Total revenues for the three months ended September 30, 2025, were $1.936 million, a significant increase from $463,000 in the same period of 2024[30] - Collaboration revenues for the nine months ended September 30, 2025, were $5.931 million, up from $1.547 million for the same period in 2024[30] - Net loss for Q3 2025 was $306.2 million, or $(2.55) per share, compared to a net loss of $160.5 million, or $(1.36) per share, in Q3 2024[17] - The net loss for the three months ended September 30, 2025, was $306.178 million, compared to a net loss of $160.545 million for the same period in 2024, indicating a substantial increase in losses[30] Expenses - R&D expenses for Q3 2025 were $99.2 million, compared to $84.6 million in Q3 2024, reflecting a 17% increase primarily due to advancing clinical trials[13] - Research and development expenses for the three months ended September 30, 2025, were $99.233 million, compared to $84.612 million for the same period in 2024, reflecting a 17.5% increase[30] - G&A expenses for Q3 2025 were $69.5 million, an increase from $56.7 million in Q3 2024, marking a 22% rise attributed to commercial readiness investments[14] - The company reported interest expense of $11.353 million for the three months ended September 30, 2025, compared to $8.928 million for the same period in 2024, marking a 27.5% increase[30] Cash and Assets - As of September 30, 2025, the company had approximately $1.25 billion in cash, cash equivalents, and investments, up from $1.04 billion at June 30, 2025[16] - Cash and short-term investments as of September 30, 2025, were $962.535 million, down from $1.076 billion as of December 31, 2024, representing a decrease of approximately 10.5%[27] - Total assets as of September 30, 2025, were $1.437 billion, an increase from $1.402 billion as of December 31, 2024[27] - Total liabilities increased to $1.958 billion as of September 30, 2025, compared to $1.537 billion as of December 31, 2024, reflecting a rise of approximately 27.4%[27] - The accumulated deficit as of September 30, 2025, was $(3.304) billion, compared to $(2.702) billion as of December 31, 2024, indicating an increase in the deficit[28] Clinical Trials and Regulatory Updates - The company expects a potential EMA decision regarding the MAA for aficamten in 1H 2026, with ongoing regulatory reviews in China and the EU[6] - Aficamten demonstrated a peak oxygen uptake improvement of +2.3 mL/kg/min compared to metoprolol in the MAPLE-HCM trial, with p<0.001[6] - Ongoing clinical trials for aficamten include ACACIA-HCM and CAMELLIA-HCM, with topline results expected in Q2 2026[6] - The company anticipates announcing results of the ACACIA-HCM trial in the second quarter of 2026, indicating ongoing clinical development efforts[24] Financial Guidance - The company updated its full-year 2025 financial guidance for GAAP operating expenses to $680 million to $700 million, reflecting investments for aficamten's potential approval[18] - The company issued $750 million in 1.75% Convertible Senior Notes due 2031, with net proceeds of $729.5 million after expenses[16]

Core Insights - Cytokinetics is progressing towards the PDUFA date of December 26, 2025, for aficamten, a cardiac myosin inhibitor aimed at treating obstructive hypertrophic cardiomyopathy (HCM) [1][3] - The company reported a strong financial position with approximately $1.25 billion in cash, cash equivalents, and investments as of September 30, 2025 [1][12] - Aficamten has shown promising clinical trial results, demonstrating superiority over metoprolol in improving exercise capacity and cardiac function in patients with obstructive HCM [3][4] Regulatory and Clinical Developments - The company is actively supporting the NDA review for aficamten by the FDA and has engaged in discussions regarding its Risk Evaluation and Mitigation Strategy (REMS) [3] - Aficamten is also under review in the European Union and China, with a potential EMA decision expected in the first half of 2026 [3] - The MAPLE-HCM trial results presented at the European Society of Cardiology Congress 2025 showed a significant improvement in peak oxygen uptake (pVO2) with aficamten compared to metoprolol [3][4] Financial Performance - Total revenues for Q3 2025 were $1.9 million, a significant increase from $0.5 million in Q3 2024 [9] - Research and Development (R&D) expenses for Q3 2025 were $99.2 million, up from $84.6 million in the same period last year, primarily due to advancing clinical trials [10] - The net loss for Q3 2025 was $306.2 million, compared to a net loss of $160.5 million in Q3 2024, which included a debt conversion expense of $121.2 million [14][25] Corporate Developments - James M. Daly has been appointed to the Board of Directors, bringing expertise in commercialization [7] - The company is enhancing its commercial readiness for aficamten, including sales force training and payer engagement [4][3] Future Guidance - The company updated its full-year 2025 financial guidance, projecting GAAP operating expenses between $680 million and $700 million [15][16] - The anticipated increase in operating expenses is attributed to investments in commercial readiness for aficamten's potential approval and launch [16]

Cytokinetics, Incorporated, listed on NASDAQ as CYTK, is a biopharmaceutical company known for its innovative work in muscle biology. The company is advancing a promising pipeline of cardiovascular drugs. As CYTK prepares to release its quarterly earnings on November 5, 2025, Wall Street anticipates an earnings per share of -$1.59 and revenue of approximately $6.05 million.Despite a negative price-to-earnings (P/E) ratio of -11.75, CYTK remains a focal point for investors. The company's price-to-sales ratio ...

Core Insights - Cytokinetics is participating in investor conferences in November 2025, providing opportunities for stakeholders to engage with the management team [1][6]. Company Overview - Cytokinetics is a specialty cardiovascular biopharmaceutical company with over 25 years of experience in muscle biology, focusing on developing new medicines for cardiac muscle dysfunction [2]. - The company is preparing for potential regulatory approvals and commercialization of aficamten, a cardiac myosin inhibitor, following positive results from the SEQUOIA-HCM Phase 3 clinical trial for obstructive hypertrophic cardiomyopathy (HCM) [2]. - Additional clinical trials are ongoing for aficamten in both obstructive and non-obstructive HCM [2]. - Cytokinetics is also developing omecamtiv mecarbil for heart failure with severely reduced ejection fraction (HFrEF), ulacamten for heart failure with preserved ejection fraction (HFpEF), and CK-089 for specific muscular dystrophies and impaired skeletal muscle function [2].

Core Viewpoint - A class action lawsuit has been filed against Cytokinetics, alleging that the company made materially false and misleading statements regarding the New Drug Application (NDA) submission and approval process for aficamten, leading to significant investor losses [8]. Allegation Details - The lawsuit claims that Cytokinetics misrepresented the expected timeline for FDA approval of aficamten, stating it would occur in the second half of 2025, while failing to disclose risks related to the omission of a Risk Evaluation and Mitigation Strategy (REMS) [8]. - On May 6, 2025, it was revealed during an earnings call that the company had discussions with the FDA about safety monitoring but chose to submit the NDA without a REMS, misleading investors about the regulatory timeline [8]. Next Steps - Investors who purchased Cytokinetics shares between December 27, 2023, and May 6, 2025, and suffered losses are encouraged to contact the law firm Bragar Eagel & Squire for more information and to discuss their legal rights [4][8]. - The deadline for investors to apply to be appointed as lead plaintiff in the lawsuit is November 17, 2025 [8]. About the Law Firm - Bragar Eagel & Squire, P.C. is a nationally recognized law firm that represents individual and institutional investors in complex litigation across the United States [5].

Core Viewpoint - The Gross Law Firm has issued a notice to shareholders of Cytokinetics, Incorporated regarding a class action lawsuit related to misleading statements about the New Drug Application (NDA) for aficamten, which may have led to significant financial losses for investors [1]. Group 1: Allegations and Timeline - The class period for the allegations is from December 27, 2023, to May 6, 2025 [1]. - Defendants allegedly made materially false statements about the expected FDA approval timeline for aficamten, claiming it would be approved in the second half of 2025 based on a September 26, 2025 PDUFA date [1]. - The company failed to disclose risks associated with not submitting a Risk Evaluation and Mitigation Strategy (REMS), which could delay the regulatory process [1]. Group 2: Impact on Shareholders - On May 6, 2025, it was revealed during an earnings call that the company had multiple pre-NDA meetings with the FDA but chose to submit the NDA without a REMS, misleading investors about the regulatory timeline [1]. - As a result of these misleading statements, class members purchased Cytokinetics' common stock at artificially inflated prices and suffered significant losses when the truth was disclosed [1]. Group 3: Next Steps for Shareholders - Shareholders are encouraged to register for the class action by November 17, 2025, to participate in the case without any cost or obligation [2]. - Registered shareholders will be enrolled in a portfolio monitoring software to receive updates throughout the lifecycle of the case [2].

Core Viewpoint - A class action securities lawsuit has been filed against Cytokinetics, alleging securities fraud related to misleading statements about the New Drug Application (NDA) for aficamten, which affected investors between December 27, 2023, and May 6, 2025 [1][2]. Group 1: Lawsuit Details - The lawsuit claims that Cytokinetics made materially false and misleading statements regarding the expected timeline for FDA approval of aficamten, indicating approval in the second half of 2025 based on a September 26, 2025 PDUFA date [2]. - It is alleged that the company failed to disclose significant risks associated with not submitting a Risk Evaluation and Mitigation Strategy (REMS), which could delay the regulatory process [2]. - During an earnings call on May 6, 2025, it was revealed that the company had discussions with the FDA about safety monitoring and risk mitigation but chose to submit the NDA without a REMS, misleading investors about the regulatory timeline [2]. Group 2: Investor Information - Investors who suffered losses in Cytokinetics during the specified timeframe have until November 17, 2025, to request to be appointed as lead plaintiff, although participation in any recovery does not require serving as a lead plaintiff [3]. - Class members may be entitled to compensation without any out-of-pocket costs or fees, and there is no obligation to participate [3]. Group 3: Firm Background - Levi & Korsinsky has a history of securing hundreds of millions of dollars for shareholders and has been recognized as one of the top securities litigation firms in the United States for seven consecutive years [4].