CYTK

EX-99.1

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EX-99.1

EX-99.1

Exhibit 99.1

Cytokinetics Reports Third Quarter 2026 Financial Results and Provides Business Update

MYQORZO® (aficamten) Net Product Revenue of $44.5 Million

Expect to Submit Supplemental NDA for Aficamten in Non-Obstructive HCM in Q4 2026 and Type II Variation in the European Union in Early 2027

~$1.6 Billion in Cash, Cash Equivalents and Investments as of September 30, 2026

SOUTH SAN FRANCISCO, Calif., Nov. 4, 2026 - Cytokinetics, Incorporated (Nasdaq: CYTK) reported a management update and financial results for the third quarter of 2026.

“Our third quarter results demonstrate continued strong execution as Cytokinetics enters its next phase of growth as a global specialty cardiology biopharmaceutical company,” said Robert I. Blum, Cytokinetics’ President and Chief Executive Officer. “In the U.S., the launch of MYQORZO continued to build solid momentum and increased velocity with growing adoption across a broadening base of prescribers. Internationally, we continued to expand access to MYQORZO to bring this important medicine to more patients around the world. Now, with our having presented and published the primary results from ACACIA-HCM, the first positive Phase 3 clinical trial in nHCM, we believe aficamten has the potential to become the first and only cardiac myosin inhibitor approved across the full spectrum of HCM. Building on these key results, we are moving swiftly to seek regulatory approvals in both the U.S. and Europe, important next steps toward achieving our Vision 2030.”

Q3 and Recent Highlights

Cardiac Muscle Programs

MYQORZO® (aficamten) (cardiac myosin inhibitor)

• Continued to drive launch momentum for MYQORZO. Year-to-date (YTD) as of September 30, 2026:

o Nearly 1,100 unique healthcare providers have prescribed MYQORZO.

o Over 2,800 patients have been dispensed MYQORZO.

• MYQORZO received authorization from Health Canada for patients with symptomatic obstructive hypertrophic cardiomyopathy (oHCM) of New York Heart Association (NYHA) class II-III in adult patients.

• MYQORZO was granted marketing authorization across the United Kingdom by the Medicines and Healthcare products Regulatory Agency (MHRA) for the treatment of symptomatic oHCM of NYHA class II-III in adult patients. The National Institute for Health and Care Excellence (NICE) issued guidance recommending aficamten for use in eligible adult patients in England and Wales. We expect to launch MYQORZO in the United Kingdom in Q4 2026 and in additional countries in 2027.

• Presented the positive primary results from ACACIA-HCM, the pivotal Phase 3 clinical trial of aficamten in patients with symptomatic non-obstructive hypertrophic cardiomyopathy (nHCM) in a Hot Line Session at the European Society of Cardiology Congress (ESC) and published in the New England Journal of Medicine. We expect to file a Supplemental New Drug Application (NDA) for nHCM in Q4 2026 and a Type II Variation in the European Union in early 2027.

• Presented analyses from ACACIA-HCM and SEQUOIA-HCM at the HFSA Annual Scientific Meeting 2026, including two late-breaking presentations, further characterizing the efficacy and safety of aficamten in nHCM and oHCM.

• Advanced the ongoing clinical trials program for aficamten:

o Recently initiated ASPEN-HCM, a real-world study of MYQORZO in symptomatic oHCM.

o Completed conduct of the main study treatment period of CAMELLIA-HCM, a Phase 3 clinical trial of aficamten in Japanese patients with oHCM. CAMELLIA-HCM is being conducted by Bayer in collaboration with Cytokinetics to support potential marketing authorization in Japan.

o Recently completed conduct of the Japan cohort of ACACIA-HCM.

o Recently completed conduct of the adolescent cohort of CEDAR-HCM, a clinical trial of aficamten in a pediatric population with symptomatic oHCM. We expect to present topline data in early 2027.

• Published the following manuscripts:

o “Aficamten for Symptomatic Nonobstructive Hypertrophic Cardiomyopathy” in New England Journal of Medicine.

o “Effect of Aficamten on Cardiac Structure and Function in Patients with Symptomatic Nonobstructive Hypertrophic Cardiomyopathy” in Circulation.

o “Global Efficacy of Aficamten in Nonobstructive Hypertrophic Cardiomyopathy: Results From ACACIA-HCM” in Circulation.

o “Efficacy of Aficamten vs Metoprolol According to Pretrial Beta-Blocker Treatment in Obstructive Hypertrophic Cardiomyopathy: Insights From MAPLE-HCM” in JACC: Heart Failure.

omecamtiv mecarbil (cardiac myosin activator)

• Continued conduct of COMET-HF, a confirmatory Phase 3 clinical trial of omecamtiv mecarbil in patients with symptomatic heart failure with severely reduced ejection fraction. We expect enrollment to continue through 2027.

ulacamten (cardiac myosin inhibitor)

• Continued conduct of Cohort 1 of AMBER-HFpEF, a Phase 2 clinical trial of ulacamten in patients with symptomatic heart failure with preserved ejection fraction (HFpEF) with left ven

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EX-99.1

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EX-99.1

Cytokinetics Reports First Quarter 2026 Financial Results and Provides Business Update

U.S. Launch of MYQORZO® (aficamten) in Late January Met with Strong Demand;

Over 275 HCPs Prescribed MYQORZO to an estimated 680 Patients in Q1

ACACIA-HCM Met Dual Primary Endpoints of KCCQ and Maximal Exercise Performance;

Full Results to be Presented at Upcoming Medical Congress

MYQORZO Approved by the European Commission for Adults with Symptomatic Obstructive HCM; Supplemental NDA for MAPLE-HCM Accepted for Filing by FDA with PDUFA Date of November 14, 2026

Net Product Revenues for MYQORZO of $4.8 Million for Initial Partial Quarter;

~$1.1 Billion in Cash, Cash Equivalents and Investments as of March 31, 2026

SOUTH SAN FRANCISCO, Calif., May 5, 2026 - Cytokinetics, Incorporated (Nasdaq: CYTK) reported a management update and financial results for the first quarter of 2026.

“The U.S. launch of MYQORZO commenced strongly in late January and continues to accelerate. We promptly activated a solid prescriber base of early adopters and are encouraged by initial commercial metrics that are exceeding our expectations,” said Robert I. Blum, Cytokinetics’ President and Chief Executive Officer. “In addition, today we shared positive topline results from ACACIA-HCM in non-obstructive HCM showing that aficamten improved both symptoms and maximal exercise performance, a milestone achievement that opens the aperture for aficamten to potentially address the entire spectrum of HCM. We look forward to building on our strong start and driving meaningful progress for both the commercial launch of MYQORZO and the continued advancement of our pipeline.”

Q1 and Recent Highlights

Cardiac Muscle Programs

MYQORZO® (aficamten) (cardiac myosin inhibitor)

• Began U.S. commercial launch of MYQORZO for adults with symptomatic obstructive HCM (oHCM) in January, with drug availability beginning on January 27, 2026. Activated online portal for MYQORZO REMS simultaneous with drug availability, launched promotional patient and healthcare professional (HCP) marketing campaigns to educate and build on already strong HCP awareness, and began peer-to-peer education to accelerate adoption across the HCM community.

• Drove early launch momentum for MYQORZO with strong engagement, adoption and demand. As of March 31, 2026:

o Over 1,400 HCPs REMS certified

o Over 275 unique healthcare providers prescribed MYQORZO

o Approximately 680 patients prescribed MYQORZO

o Over 70% of patients on therapy on paid prescription

• Received approval from the European Commission (EC) for MYQORZO for the treatment of symptomatic (NYHA class II-III) oHCM in adult patients.

• Advanced European commercial readiness activities ahead of first expected launch in Germany in Q2 2026. Completed hiring of our full team in Germany inclusive of sales, marketing, market access and medical.

• Announced positive topline results from ACACIA-HCM, the pivotal Phase 3 clinical trial of aficamten in patients with symptomatic non-obstructive hypertrophic cardiomyopathy (nHCM). ACACIA-HCM met both dual primary endpoints, demonstrating statistically significant improvements from baseline to Week 36 in both Kansas City Cardiomyopathy Questionnaire (KCCQ) Clinical Summary Score and maximal exercise performance (peak VO2). Statistically significant improvements compared to placebo were also observed in key secondary endpoints.

• The Supplemental New Drug Application for MAPLE-HCM was accepted for filing by the U.S. Food and Drug Administration (FDA) with a PDUFA date of November 14, 2026.

• Submitted a Marketing Authorization Application for aficamten to Swissmedic. Aficamten has been granted Orphan Drug Status by Swissmedic.

• Aficamten was granted Orphan Drug Designation by the Japan Ministry of Health, Labour and Welfare for the treatment of patients with nHCM and pediatric patients with oHCM.

• Advanced the ongoing clinical trials program for aficamten:

o Continued conduct of the Japan cohort of ACACIA-HCM.

o Continued conduct of CAMELLIA-HCM, a Phase 3 clinical trial of aficamten in Japanese patients with oHCM. CAMELLIA-HCM is being conducted by Bayer in collaboration with Cytokinetics to support potential marketing authorization in Japan.

o Continued patient enrollment in CEDAR-HCM, a clinical trial of aficamten in a pediatric population with symptomatic oHCM. We expect to complete enrollment of the adolescent cohort in Q4 2026.

• Presented new analyses at the American College of Cardiology (ACC) Annual Scientific Session & Expo from SEQUOIA-HCM, MAPLE-HCM and FOREST-HCM supporting previously published data related to the safety and efficacy of aficamten in oHCM.

omecamtiv mecarbil (cardiac myosin activator)

• Continued conduct of COMET-HF, a confirmatory Phase 3 clinical trial of omecamtiv mecarbil in patients with symptomatic heart failure with severely reduced ejection fraction. We expect to continue patient enrollment th