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 ...

Core Insights - Cytokinetics announced favorable results from the SEQUOIA-HCM trial, demonstrating that aficamten significantly improves cardiac remodeling, structure, function, and patient symptoms in individuals with symptomatic obstructive hypertrophic cardiomyopathy (HCM) [1][2][3] Clinical Trial Results - The SEQUOIA-HCM trial presented data showing that aficamten treatment led to a significant reduction in left ventricular mass index (LVMI) by -15.4 g/m² (p=0.001) and improvements in left ventricular maximal wall thickness, left atrial volume index, and extracellular volume mass index [3][4] - Aficamten improved echocardiographic measures, including a 60% reduction in left ventricular outflow tract gradient (LVOT-G) and no adverse changes in left ventricular ejection fraction (LVEF) [5][6] - The treatment resulted in significant improvements in patient-reported outcomes, with a 7.9-point increase in the Kansas City Cardiomyopathy Questionnaire Overall Summary Score (KCCQ-OSS) and a 7.8-point increase in the Seattle Angina Questionnaire Summary Score (SAQ-SS) [7][8] Biomarker Improvements - Aficamten treatment led to an 80% reduction in NT-proBNP and a 43% reduction in high-sensitivity cardiac troponin (hs-cTnI), both significant indicators of cardiac stress and injury [9][10] - Improvements in NT-proBNP were associated with enhanced exercise capacity and symptom relief, indicating its potential as a monitoring tool for treatment response [9][10] Future Developments - Cytokinetics plans to submit a New Drug Application (NDA) for aficamten to the FDA in Q3 2024 and a Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) in Q4 2024 [12][15] - The company is also conducting additional studies, including the MAPLE-HCM trial and the ACACIA-HCM trial, to further evaluate aficamten's efficacy in different patient populations [13][15]

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 ...

Financial Data and Key Metrics Changes - The company reported a net loss of $143.3 million or $1.31 per share for Q2 2024, compared to a net loss of $128.6 million or $1.34 per share for the same period in 2023 [36] - Cash, cash equivalents, and investments increased to approximately $1.4 billion at the end of Q2 2024, up from $634.3 million at the end of Q1 2024, primarily due to a public offering and a strategic financing agreement [33][34] Business Line Data and Key Metrics Changes - Aficamten's clinical trial SEQUOIA-HCM showed significant improvements in exercise capacity, with a peak VO2 increase of 1.7 milliliters per kilo per minute compared to placebo [10] - The company is on track to complete enrollment in the MAPLE-HCM trial during Q3 2024, which evaluates aficamten's superiority over metoprolol in obstructive HCM [14] Market Data and Key Metrics Changes - The company is preparing for a market development campaign for aficamten, set to launch next month, and is engaging with U.S. payers to discuss the results of SEQUOIA-HCM [23][24] Company Strategy and Development Direction - The company aims to build a specialty cardiology franchise, focusing on aficamten and its potential as a first-line therapy for HCM, while also exploring external R&D opportunities [40][41] - The company plans to submit an NDA for aficamten to the FDA in Q3 2024 and an MAA to the EMA in Q4 2024, with ongoing preparations for submissions in China [43][21] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the progress made with the FDA regarding aficamten's NDA submission and the potential for a distinct risk mitigation profile [42] - The company recognizes the need to maximize shareholder value and is open to exploring M&A opportunities while focusing on building its pipeline [40] Other Important Information - The company has initiated a Phase 1 study for aficamten in healthy participants to gather data for potential approval in Japan [17] - The company plans to start a confirmatory Phase 3 clinical trial for omecamtiv mecarbil in Q4 2024, targeting patients with severe heart failure [29][44] Q&A Session Summary Question: Inquiry about Isaac's role and business development activities - Management clarified that Isaac's role focuses on corporate development rather than immediate business development activities related to aficamten or omecamtiv mecarbil [45][47] Question: Clarification on the protocol amendment for FOREST - Management indicated that the FDA's acceptance of the protocol amendment for FOREST is encouraging but does not directly correlate with the potential risk mitigation profile for aficamten [50][52] Question: Discussion on MAPLE trial and its implications - Management confirmed that MAPLE results are expected to be available before aficamten's potential approval but will not be included in the NDA submission [70] Question: Questions regarding the development of omecamtiv mecarbil - Management stated that operational aspects are being finalized for the upcoming Phase 3 trial of omecamtiv mecarbil, with a focus on a higher-risk patient population [68][69]

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 ...

Management Update and Q2 Highlights [Overview](index=1&type=section&id=Overview) Cytokinetics made significant Q2 2024 progress in cardiac muscle programs, securing over **$1 billion** in funding and advancing aficamten's regulatory milestones - Held a Type B Meeting with the FDA to discuss potential risk mitigation strategies for aficamten[1](index=1&type=chunk)[3](index=3&type=chunk) - Initiated the rolling New Drug Application (NDA) submission for aficamten, with completion expected in Q3 2024[1](index=1&type=chunk)[3](index=3&type=chunk) - Secured contingent access to over **$1 billion** in funding to support the potential global launch of aficamten and advance the later-stage pipeline[2](index=2&type=chunk) - The FDA cleared a protocol amendment for the FOREST-HCM trial, reducing the frequency of required echocardiographic monitoring during maintenance treatment[1](index=1&type=chunk)[4](index=4&type=chunk) [Cardiac Muscle Programs Update](index=2&type=section&id=Cardiac%20Muscle%20Programs%20Update) Cardiac muscle programs are advancing with aficamten's global regulatory progress, omecamtiv mecarbil's planned Phase 3, CK-586's Phase 2a, and CK-136's discontinuation [aficamten (cardiac myosin inhibitor)](index=2&type=section&id=aficamten%20(cardiac%20myosin%20inhibitor)) Aficamten showed significant clinical improvements in SEQUOIA-HCM, with rapid regulatory progress including a rolling US NDA, planned EU MAA, and China NDA - Primary results from the SEQUOIA-HCM trial showed statistically significant and clinically meaningful improvements in the primary endpoint of peak oxygen uptake (pVO2)[2](index=2&type=chunk) - The rolling NDA submission for aficamten is underway and on track for completion in Q3 2024[3](index=3&type=chunk) - The company plans to submit a Marketing Authorization Application (MAA) for aficamten to the European Medicines Agency (EMA) in Q4 2024[4](index=4&type=chunk) - Enrollment is ongoing for MAPLE-HCM (vs. metoprolol), ACACIA-HCM (non-obstructive), and CEDAR-HCM (pediatric) trials[5](index=5&type=chunk)[6](index=6&type=chunk) - Commercial readiness activities are underway, including market development, patient support program design, and payer engagement[5](index=5&type=chunk) [omecamtiv mecarbil (cardiac myosin activator)](index=3&type=section&id=omecamtiv%20mecarbil%20(cardiac%20myosin%20activator)) Following FDA discussions, Cytokinetics is preparing for a confirmatory Phase 3 trial of omecamtiv mecarbil in HFrEF patients, expected in Q4 2024 - Participated in a Type C meeting with the FDA to discuss the design of a confirmatory Phase 3 trial[7](index=7&type=chunk) - A confirmatory Phase 3 trial in patients with HFrEF is expected to start in Q4 2024[7](index=7&type=chunk) [CK-4021586 (CK-586, cardiac myosin inhibitor)](index=3&type=section&id=CK-4021586%20(CK-586%2C%20cardiac%20myosin%20inhibitor)) Positive Phase 1 data for CK-586 supports its progression to a Phase 2a clinical trial in HFpEF patients, planned for Q4 2024 - Announced positive topline data from the Phase 1 study, with primary data expected to be presented in Q3 2024[8](index=8&type=chunk) - The company plans to initiate a Phase 2a clinical trial in patients with HFpEF in Q4 2024[8](index=8&type=chunk) [CK-3828136 (CK-136, cardiac troponin activator)](index=4&type=section&id=CK-3828136%20(CK-136%2C%20cardiac%20troponin%20activator)) CK-136's Phase 1 study met safety objectives, but further development was discontinued due to strategic prioritization - The Phase 1 study met its primary objectives for safety, tolerability, and pharmacokinetics[9](index=9&type=chunk) - Further development of CK-136 has been discontinued due to the company's strategic prioritization of other clinical trial programs[9](index=9&type=chunk) [Pre-Clinical and Corporate Updates](index=4&type=section&id=Pre-Clinical%20and%20Corporate%20Updates) Pre-clinical development continues in muscle biology, with a Phase 1 trial for a fast skeletal troponin activator planned for 2024, and a CLIMB Research Symposium - Expects to initiate Phase 1 clinical development of a fast skeletal troponin activator for a specific type of muscular dystrophy in 2024[10](index=10&type=chunk) - Hosted the inaugural CLIMB Research Symposium, bringing together scientists and researchers in the field of muscle biology[11](index=11&type=chunk) Second Quarter 2024 Financial Results [Financial Position and Liquidity](index=4&type=section&id=Financial%20Position%20and%20Liquidity) As of June 30, 2024, Cytokinetics held approximately **$1.4 billion** in cash, bolstered by **$563.2 million** from a stock offering and **$250 million** from a strategic collaboration Cash Position | Date | Cash, Cash Equivalents and Investments | | :--- | :--- | | June 30, 2024 | ~$1.4 billion | | March 31, 2024 | $634.3 million | - Completed a public offering of common stock, raising approximately **$563.2 million** in net proceeds[12](index=12&type=chunk) - Entered into a strategic funding collaboration with Royalty Pharma for up to **$575 million**, receiving **$250 million** upon execution[12](index=12&type=chunk) [Financial Performance (Statement of Operations)](index=4&type=section&id=Financial%20Performance%20(Statement%20of%20Operations)) Q2 2024 saw total revenues of **$0.2 million** and a widened net loss of **$143.3 million**, primarily due to increased G&A expenses for commercial readiness Q2 2024 Statement of Operations Summary (in millions, except per share data) | Metric | Q2 2024 | Q2 2023 | | :--- | :--- | :--- | | Total Revenues | $0.2 | $0.9 | | R&D Expenses | $79.6 | $83.2 | | G&A Expenses | $50.8 | $39.7 | | Net Loss | $(143.3) | $(128.6) | | Net Loss Per Share | $(1.31) | $(1.34) | - The decrease in R&D expenses was primarily due to the timing of clinical trial activities and the wind-down of the COURAGE-ALS trial[14](index=14&type=chunk) - The increase in G&A expenses was primarily driven by investments in commercial readiness and personnel-related costs[15](index=15&type=chunk) [Balance Sheet Summary](index=7&type=section&id=Balance%20Sheet%20Summary) As of June 30, 2024, total assets increased to **$1.52 billion**, and stockholders' equity improved to **$108.6 million** from a **$386.3 million** deficit Condensed Balance Sheet Highlights (in thousands) | Metric | June 30, 2024 | Dec 31, 2023 | | :--- | :--- | :--- | | Total Assets | $1,523,788 | $824,316 | | Total Liabilities | $1,415,238 | $1,210,639 | | Total Stockholders' Equity (Deficit) | $108,550 | $(386,323) | [2024 Financial Guidance](index=5&type=section&id=2024%20Financial%20Guidance) The company updated its 2024 financial guidance, increasing GAAP operating expenses to **$555 million** to **$575 million** and Non-GAAP operating expenses to **$445 million** to **$470 million** Updated Full Year 2024 Financial Guidance | Metric | Current Guidance | Previous Guidance | | :--- | :--- | :--- | | GAAP Operating Expense | $555m to $575m | $535m to $555m | | Non-GAAP Operating Expense | $445m to $470m | $420m to $450m | | Net Cash Utilization | $400m to $420m | $390m to $420m |

Core Viewpoint - Cytokinetics has launched a Corporate Giving Program aimed at supporting non-profit organizations that promote diversity in science education and equitable healthcare initiatives, particularly in cardiovascular disease, with a focus on local and at-risk communities [1][2]. Group 1: Corporate Giving Program - The Cytokinetics Corporate Giving Program will provide individual charitable donations up to $20,000 to qualified 501(c)(3) organizations in the United States [2]. - The program specifically targets organizations that are not directly involved in healthcare practices, focusing on diversity in science education and essential services for local communities in the San Francisco Bay Area and Greater Philadelphia Region [2]. - Applications for the program can be submitted online, with a deadline set for September 16, 2024 [1][2]. Group 2: Company Overview - Cytokinetics is a late-stage, specialty cardiovascular biopharmaceutical company focused on developing drug candidates that enhance cardiac muscle performance [3]. - The company is preparing for regulatory submissions for aficamten, a cardiac myosin inhibitor, following positive results from the SEQUOIA-HCM Phase 3 clinical trial [3]. - Cytokinetics is also involved in multiple clinical trials for aficamten, including MAPLE-HCM, ACACIA-HCM, CEDAR-HCM, and FOREST-HCM, targeting various forms of hypertrophic cardiomyopathy [3].