Phase 2 Clinical Trial in Patients with Heart Failure with Preserved Ejection Fraction Expected to Begin in Q4 2024 SOUTH SAN FRANCISCO, Calif., Sept. 09, 2024 (GLOBE NEWSWIRE) -- Cytokinetics, Incorporated (Nasdaq: CYTK) today announced that data from the Phase 1 study of CK-4021586 (CK-586) were presented in a poster session at the American College of Clinical Pharmacology (ACCP) Annual Meeting in Bethesda, MD. The study met its primary and secondary objectives to assess the safety, tolerability and pharm ...

Data from Integrated Safety Analysis Across Three Clinical Trials Reinforces Robust Safety Profile of Aficamten Analysis from FOREST-HCM Demonstrates Successful Withdrawal of Standard of Care Medications in Patients with Obstructive HCM Treated with Aficamten Company to Host Conference Call and Webcast Tuesday, September 3rd at 8:00 AM Eastern Time SOUTH SAN FRANCISCO, Calif., Sept. 01, 2024 (GLOBE NEWSWIRE) -- Cytokinetics, Incorporated (Nasdaq: CYTK) today announced that new data related to the safety and ...

Additional Data from SEQUOIA-HCM Demonstrate Favorable Cardiac Remodeling by Cardiac MRI, Improvements in Cardiac Structure and Function by Echocardiography, Symptom Relief and Improvement in Biomarkers with Aficamten Presentations Accompanied by Four Simultaneous Journal Publications Company to Host Conference Call and Webcast Tuesday, September 3rd at 8:00 AM Eastern Time SOUTH SAN FRANCISCO, Calif., Sept. 01, 2024 (GLOBE NEWSWIRE) -- Cytokinetics, Incorporated (Nasdaq: CYTK) today announced that addition ...

SOUTH SAN FRANCISCO, Calif., Aug. 29, 2024 (GLOBE NEWSWIRE) -- Cytokinetics, Incorporated (Nasdaq: CYTK) today announced that the Company is scheduled to participate in the following investor conferences in September: Morgan Stanley 22nd Annual Global Healthcare Conference: Cytokinetics will participate in a fireside chat on Wednesday, September 4, 2024 at 7:45 AM Eastern Time at the New York Marriott Marquis Hotel in New York, NY. H.C. Wainwright 26th Annual Global Investment Conference: Cytokinetics will ...

Cytokinetics, Incorporated (NASDAQ:CYTK) Q2 2024 Earnings Conference Call August 8, 2024 4:30 PM ET Company Participants Diane Weiser - VP, Corporate Affairs Robert Blum - President, CEO Fady Malik - EVP, R&D Chris Murray - SVP, Regulatory Affairs and Quality Andrew Callos - EVP and Chief Commercial Officer Stuart Kupfer - SVP and Chief Medical Officer Sung Lee - EVP and CFO Conference Call Participants Salim Syed - Mizuho Akash Tewari - Jefferies Roanna Ruiz - Leerink Paul Choi - Goldman Sachs Kripa Devara ...

Financial Performance - The company reported a significant increase in revenue, reaching $150 million, representing a 25% year-over-year growth[4]. - Total revenues for the three months ended June 30, 2024, were $249,000, compared to $867,000 for the same period in 2023, representing a decrease of 71.3%[13]. - The net loss for the three months ended June 30, 2024, was $(143,318,000), compared to a net loss of $(128,637,000) for the same period in 2023, indicating an 11.4% increase in losses[13]. - For the six months ended June 30, 2024, the company reported a net loss of $279.0 million, compared to a net loss of $259.9 million for the same period in 2023[21]. - The company had no milestone revenues reported for the three months ended June 30, 2024, consistent with the same period in 2023[13]. User Engagement - User data showed a 30% increase in active users, totaling 1.2 million users in the last quarter[6]. Revenue Projections and Growth - The company provided an optimistic outlook, projecting a revenue growth of 20% for the next quarter, aiming for $180 million[7]. - New product launches are expected to contribute an additional $50 million in revenue over the next fiscal year[8]. - A recent acquisition is expected to add $30 million in annual revenue, enhancing the company's portfolio[6]. Market Expansion - The company is expanding its market presence in Europe, targeting a 15% market share by the end of the year[9]. Research and Development - Research and development expenses increased by 10%, totaling $20 million, focusing on innovative therapies[10]. - Research and development revenues for the six months ended June 30, 2024, totaled $1,084,000, down from $2,980,000 in the same period of 2023, a decline of 63.6%[13]. - Research and development expenses for Q2 2024 were $79.6 million, compared to $83.2 million in Q2 2023, and for the first half of 2024, expenses were $161.2 million, down from $162.6 million in the same period of 2023[113]. Strategic Partnerships and Collaborations - The company announced a strategic partnership with a leading pharmaceutical firm to enhance product distribution[12]. - The company has entered into strategic collaborations, including a $50.0 million nonrefundable payment from Ji Xing for the development of omecamtiv mecarbil in China and Taiwan[27]. - The company expects to receive additional milestone payments totaling up to $330.0 million from Ji Xing based on commercial milestones for omecamtiv mecarbil[27]. Financial Position and Liquidity - Cash, cash equivalents, and investments increased to $1.4 billion as of June 30, 2024, up from $0.7 billion as of December 31, 2023[21]. - The company raised $924.8 million from financing activities during the reporting period, significantly improving liquidity[21]. - The company has an accumulated deficit of approximately $2.4 billion since inception, indicating ongoing financial challenges[21]. - The company believes its existing cash and investments will be sufficient to fund cash requirements for at least the next 12 months[23]. Clinical Trials and Product Development - Aficamten, a novel oral small molecule cardiac myosin inhibitor, was designed to reduce hypercontractility associated with hypertrophic cardiomyopathy (HCM) and has shown promising preclinical results[116]. - The SEQUOIA-HCM Phase 3 trial enrolled 282 patients and demonstrated that treatment with aficamten significantly improved peak oxygen uptake (pVO2) by a least square mean difference of 1.74 mL/kg/min compared to placebo (p=0.000002)[121]. - Statistically significant improvements were observed in all 10 prespecified secondary endpoints, including a 34% improvement in New York Heart Association (NYHA) Functional Class among patients treated with aficamten (p<0.0001)[123]. - Aficamten reduced NT-proBNP, a biomarker of cardiac wall stress, by 80% relative to placebo from baseline to Week 24[123]. - Treatment with aficamten resulted in patients spending 78 fewer days eligible for septal reduction therapy compared to placebo (p<0.0001)[123]. - Aficamten was well-tolerated in the SEQUOIA-HCM trial, with serious adverse events occurring in 5.6% of patients on aficamten compared to 9.3% on placebo[125]. Regulatory and Compliance - The management emphasized the importance of regulatory approvals for new products, which could significantly impact future revenue streams[8]. - The FDA issued a Complete Response Letter (CRL) on February 28, 2023, stating that GALACTIC-HF did not provide sufficient evidence of effectiveness for omecamtiv mecarbil in treating HFrEF[153]. - The company voluntarily withdrew its Marketing Authorization Application (MAA) for omecamtiv mecarbil in the EU following feedback from the EMA[155]. Debt and Financing - The company entered into the 2024 RPI Transactions with a total consideration of $200 million, allocated across various agreements[45]. - The RP OM Loan Agreement provides for a loan in a principal amount of $100 million, with specific repayment scenarios based on the success of clinical trials[47][48]. - Total borrowings as of June 30, 2024, amounted to $759.5 million, an increase from $617.5 million as of December 31, 2023[188]. - The company closed a public offering of 9,803,922 shares at $51.00 per share, generating gross proceeds of approximately $575.0 million and net proceeds of approximately $563.2 million[95]. Future Outlook - The company anticipates continued operating losses and net cash outflows in future periods[21]. - The company plans to submit an NDA for aficamten to the FDA in Q3 2024 and a marketing authorization application to EMA in Q4 2024[106].

Cytokinetics, Incorporated (CYTK) reported a net loss of $1.31 per share in the second quarter of 2024, wider than the Zacks Consensus Estimate of a loss of $1.02. In the year-ago quarter, the company reported a net loss of $1.34 per share. Cytokinetics is a late-stage, specialty cardiovascular biopharmaceutical company focused on discovering, developing and commercializing muscle biology-directed drug candidates as potential treatments for debilitating diseases in which cardiac muscle performance is compro ...

Cytokinetics (CYTK) came out with a quarterly loss of $1.31 per share versus the Zacks Consensus Estimate of a loss of $1.02. This compares to loss of $1.34 per share a year ago. These figures are adjusted for non-recurring items. This quarterly report represents an earnings surprise of -28.43%. A quarter ago, it was expected that this biopharmaceutical company would post a loss of $1.16 per share when it actually produced a loss of $1.33, delivering a surprise of -14.66%. Over the last four quarters, the c ...

CYTOKINETICS REPORTS SECOND QUARTER 2024 FINANCIAL RESULTS Type B Meeting Held with FDA Related to Potential Risk Mitigation Strategies for Aficamten; Company Has Initiated Rolling NDA Submission FDA Cleared Protocol Amendment for FOREST-HCM Reducing Frequency of Echocardiographic Monitoring Required During Maintenance Treatment ~$1.4 Billion in Cash, Cash Equivalents and Investments as of June 30, 2024 SOUTH SAN FRANCISCO, Calif., Aug. 8, 2024 - Cytokinetics, Incorporated (Nasdaq: CYTK) reported a manageme ...

Program Augments Existing Patient Advocacy and Professional Society Donations to Non-Profit Organizations Aligned with Corporate Values Deadline for Applications is September 16th, 2024 SOUTH SAN FRANCISCO, Calif., July 30, 2024 (GLOBE NEWSWIRE) -- Cytokinetics, Incorporated (Nasdaq: CYTK) today announced a call for proposals for the Cytokinetics Corporate Giving Program. The program provides charitable donations to eligible non-profit organizations in the United States to support diversity in science educa ...