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Cytokinetics Reports Fourth Quarter 2024 Financial Results and Provides Business Update

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Cytokinetics (NASDAQ: CYTK) reported Q4 and full year 2024 financial results, highlighting significant progress in its cardiac muscle programs. The company's lead drug candidate aficamten is under regulatory review in the US, Europe, and China, with a PDUFA date of September 26, 2025.

Key financial metrics include:

  • Cash position of ~$1.2 billion as of December 31, 2024
  • Q4 2024 revenues of $16.9 million vs $1.7 million in Q4 2023
  • Full year 2024 revenues of $18.5 million vs $7.5 million in 2023
  • Q4 2024 net loss of $150.0 million ($1.26 per share)
  • Full year 2024 net loss of $589.5 million ($5.26 per share)

The company entered collaborations with Bayer for aficamten commercialization in Japan and noted Sanofi's acquisition of rights for Greater China. Topline results from the MAPLE-HCM trial are expected in Q2 2025.

Cytokinetics (NASDAQ: CYTK) ha riportato i risultati finanziari del quarto trimestre e dell'intero anno 2024, evidenziando progressi significativi nei suoi programmi per il muscolo cardiaco. Il principale candidato farmaco dell'azienda, aficamten, è attualmente sotto revisione normativa negli Stati Uniti, in Europa e in Cina, con una data PDUFA fissata per il 26 settembre 2025.

I principali indicatori finanziari includono:

  • Posizione di cassa di circa 1,2 miliardi di dollari al 31 dicembre 2024
  • Entrate del quarto trimestre 2024 pari a 16,9 milioni di dollari rispetto a 1,7 milioni di dollari nel quarto trimestre 2023
  • Entrate dell'intero anno 2024 pari a 18,5 milioni di dollari rispetto a 7,5 milioni di dollari nel 2023
  • Perdita netta del quarto trimestre 2024 di 150,0 milioni di dollari (1,26 dollari per azione)
  • Perdita netta dell'intero anno 2024 di 589,5 milioni di dollari (5,26 dollari per azione)

L'azienda ha avviato collaborazioni con Bayer per la commercializzazione di aficamten in Giappone e ha notato l'acquisizione da parte di Sanofi dei diritti per la Grande Cina. I risultati preliminari dello studio MAPLE-HCM sono attesi nel secondo trimestre del 2025.

Cytokinetics (NASDAQ: CYTK) informó los resultados financieros del cuarto trimestre y del año completo 2024, destacando un progreso significativo en sus programas de músculo cardíaco. El principal candidato a fármaco de la compañía, aficamten, está bajo revisión regulatoria en EE. UU., Europa y China, con una fecha PDUFA establecida para el 26 de septiembre de 2025.

Los principales indicadores financieros incluyen:

  • Posición de efectivo de aproximadamente 1.2 mil millones de dólares al 31 de diciembre de 2024
  • Ingresos del cuarto trimestre 2024 de 16.9 millones de dólares frente a 1.7 millones de dólares en el cuarto trimestre de 2023
  • Ingresos del año completo 2024 de 18.5 millones de dólares frente a 7.5 millones de dólares en 2023
  • Pérdida neta del cuarto trimestre 2024 de 150.0 millones de dólares (1.26 dólares por acción)
  • Pérdida neta del año completo 2024 de 589.5 millones de dólares (5.26 dólares por acción)

La compañía inició colaboraciones con Bayer para la comercialización de aficamten en Japón y señaló la adquisición por parte de Sanofi de los derechos para Gran China. Se esperan resultados preliminares del ensayo MAPLE-HCM en el segundo trimestre de 2025.

사이토키네틱스 (NASDAQ: CYTK)는 2024년 4분기 및 전체 연도 재무 결과를 보고하며 심장 근육 프로그램에서의 중요한 진전을 강조했습니다. 회사의 주요 약물 후보인 아피캄텐은 미국, 유럽 및 중국에서 규제 검토 중이며, PDUFA 날짜는 2025년 9월 26일로 설정되어 있습니다.

주요 재무 지표는 다음과 같습니다:

  • 2024년 12월 31일 기준 현금 보유액 약 12억 달러
  • 2024년 4분기 수익 1,690만 달러, 2023년 4분기 170만 달러 대비
  • 2024년 전체 연도 수익 1,850만 달러, 2023년 750만 달러 대비
  • 2024년 4분기 순손실 1억 5천만 달러 (주당 1.26 달러)
  • 2024년 전체 연도 순손실 5억 8천9백50만 달러 (주당 5.26 달러)

회사는 아피캄텐의 일본 내 상용화를 위해 바이엘과 협력 관계를 맺었으며, 산오피가 대만 및 홍콩에 대한 권리를 인수한 점을 언급했습니다. MAPLE-HCM 시험의 주요 결과는 2025년 2분기에 발표될 예정입니다.

Cytokinetics (NASDAQ: CYTK) a annoncé les résultats financiers du quatrième trimestre et de l'année complète 2024, soulignant des progrès significatifs dans ses programmes de muscles cardiaques. Le principal candidat médicament de la société, aficamten, est sous examen réglementaire aux États-Unis, en Europe et en Chine, avec une date PDUFA fixée au 26 septembre 2025.

Les principaux indicateurs financiers comprennent :

  • Position de trésorerie d'environ 1,2 milliard de dollars au 31 décembre 2024
  • Revenus du quatrième trimestre 2024 de 16,9 millions de dollars contre 1,7 million de dollars au quatrième trimestre 2023
  • Revenus de l'année complète 2024 de 18,5 millions de dollars contre 7,5 millions de dollars en 2023
  • Perte nette du quatrième trimestre 2024 de 150,0 millions de dollars (1,26 dollar par action)
  • Perte nette de l'année complète 2024 de 589,5 millions de dollars (5,26 dollars par action)

L'entreprise a établi des collaborations avec Bayer pour la commercialisation d'aficamten au Japon et a noté l'acquisition par Sanofi des droits pour la Grande Chine. Les résultats préliminaires de l'essai MAPLE-HCM sont attendus au deuxième trimestre 2025.

Cytokinetics (NASDAQ: CYTK) hat die finanziellen Ergebnisse für das vierte Quartal und das gesamte Jahr 2024 veröffentlicht und dabei bedeutende Fortschritte in seinen Programmen für Herzmuskelkrankheiten hervorgehoben. Der Hauptkandidat des Unternehmens, aficamten, befindet sich in den USA, Europa und China in der regulatorischen Prüfung, mit einem PDUFA-Datum am 26. September 2025.

Wichtige Finanzkennzahlen umfassen:

  • Barmittel von etwa 1,2 Milliarden Dollar zum 31. Dezember 2024
  • Umsätze im 4. Quartal 2024 von 16,9 Millionen Dollar gegenüber 1,7 Millionen Dollar im 4. Quartal 2023
  • Umsätze für das gesamte Jahr 2024 von 18,5 Millionen Dollar gegenüber 7,5 Millionen Dollar im Jahr 2023
  • Nettoverlust im 4. Quartal 2024 von 150,0 Millionen Dollar (1,26 Dollar pro Aktie)
  • Nettoverlust für das gesamte Jahr 2024 von 589,5 Millionen Dollar (5,26 Dollar pro Aktie)

Das Unternehmen hat Kooperationen mit Bayer zur Vermarktung von aficamten in Japan eingegangen und auf den Erwerb der Rechte durch Sanofi für Großchina hingewiesen. Die Ergebnisse der MAPLE-HCM-Studie werden im 2. Quartal 2025 erwartet.

Positive
  • Strong cash position of $1.2B to support commercial launch
  • Revenue increased to $16.9M in Q4 2024 from $1.7M in Q4 2023
  • Strategic partnerships secured with Bayer (Japan) and Sanofi (Greater China)
  • Multiple regulatory reviews progressing in US, Europe, and China
Negative
  • Net loss increased to $150.0M in Q4 2024 vs $136.9M in Q4 2023
  • Annual net loss widened to $589.5M from $526.2M in 2023
  • R&D expenses increased to $93.6M in Q4 2024 from $85.0M in Q4 2023
  • G&A expenses rose to $62.3M in Q4 2024 from $44.1M in Q4 2023

Insights

Cytokinetics' Q4 and full-year 2024 results highlight a company at the precipice of transformation, with regulatory submissions for aficamten under review in three major markets (US, Europe, China) and commercial launch preparations accelerating ahead of the September 26, 2025 PDUFA date. The company's $1.2 billion cash position provides substantial runway despite the $150 million quarterly net loss, strategically positioning them to fund both the aficamten launch and continued pipeline development.

The 41% year-over-year increase in G&A expenses to $62.3 million significantly outpaces R&D growth, reflecting intensive commercial infrastructure buildout including sales force deployment, territory mapping, and patient support programs. This front-loaded investment approach is typical for companies transitioning from clinical to commercial operations and appears appropriately timed given the regulatory timeline.

Strategic geographic partnerships with Bayer (Japan) and Sanofi (Greater China) provide immediate capital infusions while leveraging established commercial networks in key Asian markets, allowing Cytokinetics to focus resources on US and European launches where profit potential is highest. The $15 million payment from the Sanofi arrangement significantly boosted Q4 revenues.

The upcoming Q2 2025 readout from MAPLE-HCM represents a critical near-term catalyst, potentially demonstrating aficamten's superiority to metoprolol as monotherapy in obstructive HCM. Positive results would strengthen the commercial positioning against established beta-blockers and potentially expand market share upon launch.

While aficamten remains the primary value driver, the advancement of omecamtiv mecarbil (COMET-HF trial), CK-586 (HFpEF program), and CK-089 (skeletal muscle activator) demonstrates pipeline diversification that could deliver multiple commercial products over the coming years, aligning with their newly announced Vision 2030 strategic objectives.

Cytokinetics' Q4 results showcase significant advancement of aficamten, their next-in-class cardiac myosin inhibitor designed with potentially improved pharmacokinetics and reduced variability compared to first-generation agents. With regulatory submissions under review in three major markets and a September 26 PDUFA date, the company is executing a comprehensive global strategy for obstructive HCM while simultaneously pursuing non-obstructive HCM through the ongoing ACACIA-HCM trial.

The upcoming MAPLE-HCM results in Q2 2025 represent a potentially game-changing catalyst. This head-to-head comparison against metoprolol could demonstrate superiority over the current standard of care, potentially accelerating adoption and reimbursement upon approval. Recent data presented at AHA showing improvements in post-exercise oxygen uptake recovery and quality of life metrics further strengthen aficamten's clinical profile, addressing important patient-centered outcomes beyond the primary hemodynamic endpoints.

Cytokinetics' strategic restart of omecamtiv mecarbil development through the COMET-HF trial demonstrates their commitment to addressing the significant unmet need in severe heart failure. By focusing specifically on patients with severely reduced ejection fraction, they're targeting the population that showed the most robust response in the previous GALACTIC-HF trial, potentially optimizing the risk-benefit profile.

The company's expanding pipeline leverages their expertise in muscle biology across cardiac and skeletal applications. The advancement of CK-586 into Phase 2 for HFpEF represents a strategic expansion into a condition affecting approximately 3 million Americans with few effective treatment options, while CK-089 extends their platform into skeletal muscle disorders.

With $1.2 billion in cash and investments, Cytokinetics appears well-positioned to fund both the aficamten commercial launch and continued pipeline development. The 41% year-over-year increase in G&A expenses signals aggressive commercial infrastructure buildout, including disease awareness campaigns, territory mapping, and patient support programs - critical foundations for a successful specialty product launch.

Commercial Launch Preparations Advancing Prior to September 26 PDUFA Date; 
Regulatory Filings Under Review in U.S., Europe and China

Topline Results from MAPLE-HCM Expected in Q2 2025

Company Provides 2025 Financial Guidance;
~$1.2 Billion in Cash, Cash Equivalents and Investments as of December 31, 2024

SOUTH SAN FRANCISCO, Calif., Feb. 27, 2025 (GLOBE NEWSWIRE) -- Cytokinetics, Incorporated (Nasdaq: CYTK) reported a management update and financial results for the fourth quarter and full year of 2024. The company also provided full year 2025 financial guidance.

“The fourth quarter of 2024 capped off a momentous year for Cytokinetics with progress and achievements across our business. With regulatory submissions on file in the U.S., Europe and China for aficamten and regulatory review activities underway, we are approaching a key inflection point, and our commercial readiness activities are on track to support planned launch activities,” said Robert I. Blum, Cytokinetics’ President and Chief Executive Officer. “During recent months, we also started important clinical trials advancing later-stage development programs, setting us up to potentially deliver multiple new medicines to patients over the next several years. With a strong balance sheet and additional access to investment capital, we are well-funded to execute the potential commercial launch of aficamten in 2025, while we advance our pipeline and continue investing in research for the benefit of all stakeholders.”

Q4 and Recent Highlights

Cardiac Muscle Programs

aficamten (cardiac myosin inhibitor)

  • The U.S. Food & Drug Administration (FDA) accepted our New Drug Application (NDA) for aficamten, a next-in-class cardiac myosin inhibitor, for the treatment of obstructive hypertrophic cardiomyopathy (HCM). The NDA was assigned standard review with a Prescription Drug User Fee Act (PDUFA) target action date of September 26, 2025. We are responding to information requests from FDA and preparing for clinical site and other inspections. We expect to participate in a mid-cycle meeting with FDA in March.
  • Submitted the 120-Day Safety Update to FDA for the NDA for aficamten with an additional ten months of safety data arising from FOREST-HCM (Follow-up, Open-Label, Research Evaluation of Sustained Treatment with Aficamten in HCM), the open label extension clinical study of aficamten in patients with HCM, consistent with previously presented data from FOREST-HCM.
  • The European Medicines Agency (EMA) validated our Marketing Authorization Application (MAA) for aficamten for the treatment of obstructive HCM. The MAA will now be reviewed by the Committee for Medicinal Products for Human Use (CHMP). We expect to receive the Day 120 List of Questions from EMA in April.
  • The Center for Drug Evaluation (CDE) of the China National Medical Products Administration (NMPA) accepted the NDA for aficamten for the treatment of obstructive HCM with Priority Review. We are responding to information requests from the NMPA and preparing for clinical site inspections.
  • Entered into a collaboration and license agreement with Bayer for the exclusive development and commercialization of aficamten in Japan for the treatment of patients with obstructive and non-obstructive HCM, subject to certain reserved development rights of Cytokinetics.
  • Announced that Sanofi acquired from Corxel Pharmaceuticals (CORXEL) the exclusive rights to develop and commercialize aficamten for the treatment of patients with obstructive and non-obstructive HCM in Greater China.
  • Presented new data related to aficamten at the American Heart Association Scientific Sessions 2024 showing that in SEQUOIA-HCM (Safety, Efficacy, and Quantitative Understanding of Obstruction Impact of Aficamten in HCM) treatment with aficamten was associated with improvements in post-exercise oxygen uptake recovery and quality of life. Additionally, an analysis from FOREST-HCM demonstrated that treatment with aficamten for 12 weeks reduced the proportion of patients who were guideline-eligible for septal reduction therapy by 97%.
  • Expanded U.S. commercial readiness activities for aficamten including launching HCM Beyond the Heart, an unbranded disease awareness campaign for healthcare professionals and patients highlighting the holistic burden of HCM. Continued building our bespoke patient support programs, advanced sales force preparations including finalizing territory deployment, sales representative recruiting timeline and sales training curriculum, and initiating market research on our promotional launch campaign.
  • Advanced European commercial readiness activities including hiring key leadership positions in Europe and Heads of France and the U.K., validating our reimbursement strategy and developing our Health Technology Assessment (HTA) dossier submissions.
  • Advanced the following clinical trials:

    • 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 metoprolol as monotherapy in patients with symptomatic obstructive HCM. Patient enrollment completed in Q3 2024, and the trial is proceeding through final data collection towards database lock.
    • 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 have completed site activations in North America, South America, Europe, and Israel and observed robust enrollment over the last few months.
    • 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.

  • Published a manuscript entitled “Standard-of-Care Medication Withdrawal in Patients With Obstructive Hypertrophic Cardiomyopathy Receiving Aficamten in FOREST-HCM” in the Journal of the American College of Cardiology.

omecamtiv mecarbil (cardiac myosin activator)

  • Started COMET-HF (Confirmation of Omecamtiv Mecarbil Efficacy Trial in Heart Failure), a confirmatory Phase 3 multi-center, double-blind, randomized, placebo-controlled trial to assess the efficacy and safety of omecamtiv mecarbil in patients with symptomatic heart failure with severely reduced ejection fraction.
  • Presented additional data from GALACTIC-HF (Global Approach to Lowering Adverse Cardiac Outcomes Through Improving Contractility in Heart Failure) at the American Heart Association Scientific Sessions 2024 demonstrating that treatment with omecamtiv mecarbil reduced the risk of the primary composite endpoint in patients with severe heart failure, independent of age and reduced the risk of ventricular arrythmias in patients with severely reduced left ventricular ejection fraction.
  • Published the following manuscripts:

    • “Optimizing the Posthospital Period After Admission for Worsening Heart Failure” in the Journal of the American College of Cardiology – Heart Failure.
    • “Clinicoeconomic Burden Among Heart Failure Patients With Severely Reduced Ejection Fraction After Hospital Admission: HF-RESTORE” in the European Heart Journal – Quality of Care and Clinical Outcomes.

CK-4021586 (CK-586, cardiac myosin inhibitor)

  • Started AMBER-HFpEF (Assessment of CK-586 in a Multi-Center, Blinded Evaluation of Safety and Tolerability Results in HFpEF), a Phase 2 randomized, placebo-controlled, double-blind, multi-center, dose-finding clinical trial in patients with symptomatic heart failure with preserved ejection fraction (HFpEF) with left ventricular ejection fraction (LVEF) ≥ 60%.

CK-4015089 (CK-089, fast skeletal muscle troponin activator)

  • Started a Phase 1 randomized, double-blind, placebo-controlled, multi-part, single and multiple ascending dose clinical study of CK-4015089 (CK-089) in healthy human participants.

Pre-Clinical Development and Ongoing Research

  • Continued pre-clinical development and research activities directed to additional muscle biology focused programs.

Corporate

  • Announced Vision 2030, our five-year strategic objectives designed to propel Cytokinetics’ aspiration to become the leading muscle-focused specialty biopharmaceutical company intent on meaningfully improving the lives of patients through global access to innovative medicines.
  • Named Robert E. Landry to the company’s Board of Directors. Mr. Landry is an accomplished pharmaceutical industry leader with over three decades of financial and operational expertise.

2025 Corporate Milestones

Cardiac Muscle Programs

aficamten (cardiac myosin inhibitor)

  • Advance NDA review activities with U.S. FDA to support the potential U.S. approval of aficamten in 2H 2025.
  • Advance go-to-market strategies and prepare to commercially launch aficamten in the U.S. in 2H 2025, subject to approval by FDA.
  • Continue go-to-market plans in Germany and expand commercial readiness activities in Europe in 2025, in preparation for potential approval by the EMA in 1H 2026.
  • Coordinate with Sanofi to support the potential approval of aficamten in China in 2H 2025, pending approval by the NMPA.
  • Report topline results from MAPLE-HCM in Q2 2025.
  • Complete patient enrollment of ACACIA-HCM in 2H 2025.
  • Complete patient enrollment of the adolescent cohort in CEDAR-HCM in 2H 2025.

omecamtiv mecarbil (cardiac myosin activator)

  • Continue patient enrollment in COMET-HF through 2025 to enable completion of enrollment in 2026.

CK-586 (cardiac myosin inhibitor)

  • Complete patient enrollment of the first two cohorts in AMBER-HFpEF in 2H 2025.

Skeletal Muscle Program

CK-089 (fast skeletal muscle troponin activator)

  • Complete the Phase 1 study of CK-089 in healthy human participants in 2025.

Ongoing Research

  • Continue ongoing pre-clinical development and research activities directed to additional muscle biology focused programs.

Fourth Quarter and Full Year 2024 Financial Results

Cash, Cash Equivalents and Investments

  • As of December 31, 2024, the company had approximately $1.2 billion in cash, cash equivalents and investments compared to $1.3 billion at September 30, 2024. Cash, cash equivalents and investments declined by approximately $60 million during the fourth quarter of 2024 and benefitted from the receipt of the $52.4 million (€50 million) payment from Bayer for the exclusive license to develop and commercialize aficamten in Japan.

Revenues

  • Total revenues for the fourth quarter of 2024 were $16.9 million compared to $1.7 million for the same period in 2023. Total revenues for the full year of 2024 were $18.5 million compared to $7.5 million in 2023. Total revenues in the fourth quarter and full year 2024 benefitted from a $15.0 million upfront payment from Corxel in connection with the assignment to Sanofi of Corxel’s rights to develop and commercialize aficamten in Greater China.

Research and Development (R&D) Expenses

  • R&D expenses for the fourth quarter of 2024 were $93.6 million, which included $12.5 million of non-cash stock-based compensation expense, compared to $85.0 million for the same period in 2023, which included $9.3 million of non-cash stock-based compensation expense. R&D expenses for the full year of 2024 were $339.4 million, which included $44.0 million of non-cash stock-based compensation expense, compared to $330.1 million in 2023, which included $32.1 million of non-cash stock-based compensation expense. The increase for both the fourth quarter and full year was primarily due to our advancing clinical trials and higher personnel-related costs.

General and Administrative (G&A) Expenses

  • G&A expenses for the fourth quarter of 2024 were $62.3 million, which included $13.8 million of non-cash stock-based compensation expense, compared to $44.1 million for the same period in 2023, which included $10.2 million of non-cash stock-based compensation expense. G&A expenses for the full year of 2024 were $215.3 million, which included $53.8 million of non-cash stock-based compensation expense, compared to $173.6 million in 2023, which included $39.9 million of non-cash stock-based compensation expense. The increase for both the fourth quarter and full year was primarily driven by investments toward commercial readiness and higher personnel-related costs.

Net Income (Loss)

  • Net loss for the fourth quarter of 2024 was $150.0 million, or $(1.26) per share, basic and diluted, compared to a net loss of $136.9 million, or $(1.38) per share, basic and diluted, for the same period in 2023. Net loss for the year of 2024 was $589.5 million, or $(5.26) per share, basic and diluted, compared to a net loss of $526.2 million, or $(5.45) per share, basic and diluted, in 2023.

2025 Financial Guidance

The company today announced financial guidance for 2025:

GAAP operating expense*$670 million to $710 million
Non-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 oHCM.

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 fourth quarter 2024 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. The live audio of the conference call can also be accessed by telephone by registering in advance at the following link: Cytokinetics Q4 2024 Earnings Conference Call. Upon registration, participants will receive a dial-in number and a unique passcode to access the call. An archived replay of the webcast will be available via Cytokinetics’ website for twelve months.

About Cytokinetics

Cytokinetics is a leading muscle biology specialty biopharmaceutical company focused on discovering, developing and commercializing muscle biology-directed drug candidates as potential treatments for debilitating diseases in which muscle performance is compromised. As a pioneer in muscle and the mechanics of muscle performance, Cytokinetics is intent on meaningfully improving the lives of patients through global access to innovative medicines. Cytokinetics is readying for potential regulatory approvals and commercialization of aficamten, a potential next-in-class 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 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 ACACIA-HCM, CEDAR-HCM and AMBER-HFpEF in the second half of 2025, our ability to complete patient enrollment of COMET-HF in 2026, 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’ Annual Report on Form 10-K for the year ended December 31, 2024. 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 Weiser
Senior Vice President, Corporate Affairs
(415) 290-7757

 
Cytokinetics, Incorporated
Condensed Consolidated Balance Sheets
(in thousands)
     
     
  December 31, 2024 December 31, 2023
  (unaudited)  
ASSETS     
Current assets:    
Cash and short-term investments $1,076,014  $614,824 
Other current assets  31,926   13,227 
Total current assets  1,107,940   628,051 
Long-term investments  145,055   40,534 
Property and equipment, net  65,815   68,748 
Operating lease right-of-use assets  75,158   78,987 
Other assets  7,705   7,996 
Total assets $1,401,673  $824,316 
LIABILITIES AND STOCKHOLDERS’ DEFICIT     
Current liabilities:    
Accounts payable and accrued liabilities $75,692  $64,148 
Short-term operating lease liabilities  18,978   17,891 
Current portion of long-term debt  11,520   10,080 
Derivative liabilities measured at fair value  11,300    
Deferred revenue  52,370    
Other current liabilities  9,814   10,559 
Total current liabilities  179,674   102,678 
Term loan, net  93,227   58,384 
Convertible notes, net  552,370   548,989 
Liabilities related to revenue participation right purchase agreements, net  462,192   379,975 
Long-term operating lease liabilities  112,582   120,427 
Liabilities related to RPI Transactions measured at fair value  137,000    
Other non-current liabilities     186 
Total liabilities  1,537,045   1,210,639 
Commitments and contingencies    
Stockholders' deficit    
Common stock  118   102 
Additional paid-in capital  2,563,876   1,725,823 
Accumulated other comprehensive income (loss)  2,398   (10)
Accumulated deficit  (2,701,764)  (2,112,238)
Total stockholders' deficit  (135,372)  (386,323)
Total liabilities and stockholders' deficit $1,401,673  $824,316 
         


 
Cytokinetics, Incorporated
Condensed Consolidated Statements of Operations
(in thousands except per share data)
(unaudited)
         
  Three Months Ended December 31, Years Ended December 31,
   2024   2023   2024   2023 
Revenues:        
License and milestone revenues $15,000  $1,000  $15,000  $3,500 
Collaboration revenues  1,927   672   3,474   4,030 
Realization of revenue participation right purchase agreement            
Total revenues  16,927   1,672   18,474   7,530 
Operating expenses:        
Research and development  93,629   84,976   339,408   330,123 
General and administrative  62,338   44,114   215,314   173,612 
Total operating expenses  155,967   129,090   554,722   503,735 
Operating loss  (139,040)  (127,418)  (536,248)  (496,205)
Interest expense  (8,938)  (7,164)  (37,701)  (28,306)
Non-cash interest expense on liabilities related to revenue participation right purchase agreements  (13,656)  (9,900)  (48,811)  (29,362)
Interest and other income, net  15,014   7,586   51,534   27,629 
Change in fair value of derivative liabilities  1,200      1,300    
Change in fair value of liabilities related to RPI Transactions  (4,600)     (19,600)   
Net loss before income taxes  (150,020)  (136,896)  (589,526)  (526,244)
Income tax benefit            
Net loss $(150,020) $(136,896) $(589,526) $(526,244)
Net loss per share — basic and diluted $(1.26) $(1.38) $(5.26) $(5.45)
Weighted-average shares in net loss per share — basic and diluted  118,075   99,067   111,979   96,524 

FAQ

When is the PDUFA date for Cytokinetics' aficamten (CYTK) in the US?

The FDA PDUFA target action date for aficamten is September 26, 2025.

What are the key revenue figures for Cytokinetics (CYTK) in Q4 2024?

CYTK reported Q4 2024 revenues of $16.9 million, compared to $1.7 million in Q4 2023.

What is Cytokinetics' (CYTK) cash position as of December 2024?

CYTK had approximately $1.2 billion in cash, cash equivalents and investments as of December 31, 2024.

When will Cytokinetics (CYTK) report MAPLE-HCM trial results?

Topline results from the MAPLE-HCM trial are expected in Q2 2025.

What partnerships did Cytokinetics (CYTK) secure for aficamten in 2024?

CYTK partnered with Bayer for Japan commercialization and Sanofi acquired rights for Greater China through Corxel.

Cytokinetics Inc

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5.60B
114.81M
0.54%
119.33%
11.89%
Biotechnology
Pharmaceutical Preparations
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United States
SOUTH SAN FRANCISCO