Cytokinetics Incorporated : Read Our 2025 Report
CYTK
Published on 04/14/2026 at 04:22 pm EDT
INTRODUCTION SCIENCE PATIENTS CULTURE INTEGRITY COMMUNITIES OPERATIONS APPENDIX Cytokinetics 2025 Corporate Responsibility Report
INTRODUCTION
INTRODUCTION SCIENCEPATIENTS CULTURE INTEGRITY COMMUNITIES OPERATIONS APPENDIX Cytokinetics 2025 Corporate Responsibility Report
About this report: In our fourth annual Corporate Responsibility Report, we share information on progress and continuing activities related to corporate responsibility and highlight advancements of our environmental, social and governance priorities that contribute to the success of our company. Unless otherwise noted, all performance reporting covers January 1, 2025 to December 31, 2025. This report
is not a comprehensive description or representation of all Cytokinetics corporate responsibilty activities at that time. All financial information is reported in United States (U.S.)
dollars. Information on documents filed with the Securities and Exchange Commission (SEC), such as our annual Form 10-K, can be found at https://www.cytokinetics.com.
our mission
To bring forward new medicines to improve the healthspan of people with devastating cardiovascular and neuromuscular diseases of impaired muscle function.
INTRODUCTION
⏹ A Message from Our CEO
⏹ About Cytokinetics
⏹ Corporate Responsibility Governance
⏹ 2025 Highlights
SCIENCE
Advancing Research that Improves Lives
⏹ Research and Development
⏹ Muscle-Directed Medicines
⏹ Product Quality and Safety
⏹ Clinical Trials
PATIENTS
Partnering with Patients and Caregivers at Every Step
⏹ Patient Centricity
⏹ Patient Engagement
⏹ Patient Education and Support
CULTURE
Cultivating Inclusion, Integrity and Excellence
⏹ Growth and Global Expansion
⏹ Human Capital Management and Development
⏹ Wellness and Benefits Program
⏹ Strength in Inclusion
INTEGRITY
Acting with Integrity and Purpose
⏹ Governance, Ethics and Compliance
⏹ Data Privacy and Cyber Security
⏹ Humane Treatment of Animals
COMMUNITIES
Supporting Communities through Partnership and Impact
⏹ Corporate Giving Program
⏹ Employee Volunteering
⏹ Community Outreach
OPERATIONS
Operating Responsibly for a Sustainable Future
⏹ Supply Chain Integrity and Sustainability
⏹ Workplace Safety
⏹ Environmental Sustainability
APPENDIX
⏹ Progress Toward Goals
⏹ ESG Data Table
⏹ SASB Index
⏹ GRI Content Index
⏹ Notes and Important Safety Information
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INTRODUCTION
INTRODUCTION SCIENCEPATIENTS CULTURE INTEGRITY COMMUNITIES OPERATIONS APPENDIX Cytokinetics 2025 Corporate Responsibility Report
A MESSAGE FROM OUR CEO
When musicians take the stage, each brings individual skill and dedication. But it is only when they perform in unison that the music reaches its full potential. Performing with Purpose reflects how Cytokinetics approached 2025-as one organization, aligned around a shared mission, each team playing its part to create something meaningful together.
This year marked a defining moment for Cytokinetics. In December 2025, MYQORZO™ (aficamten) became our first commercial medicine with approval from the U.S. Food and Drug Administration. That momentum extended globally, with approval from the China National Medical Products Administration and a positive opinion from the Committee for Medicinal Products for Human Use of the European Medicines Agency, positioning MYQORZO for potential authorization in the European Union
in early 2026*. This milestone represents the culmination of years of bold, trailblazing research in muscle biology and stands as a testament to the strength of our science and the perseverance of patients, healthcare professionals, advocates, partners and employees who made it possible. It was a historic moment for our company and for the patients we serve, as we fulfill our promise to
translate our science into medicines that may make a meaningful difference in patients' lives.
Reaching this milestone required extraordinary preparation. Throughout the year, teams across Cytokinetics worked tirelessly and in close coordination to prepare for this inflection point. While engaging with regulators during review, we simultaneously advanced commercial readiness across functions including patient support, distribution, sales and medical affairs. In 2025, we welcomed our first-ever Cardiovascular Account Specialist team, expanded our capabilities across Europe, opened a new office in Dublin, grew our presence in Radnor and South San Francisco and laid the groundwork for expansion in Zug, Switzerland.
We also introduced our Vision 2030 corporate strategy in 2025, articulating our ambition to become the leading muscle-focused specialty biopharma company dedicated to meaningfully improving patients' lives through global access to innovative medicines. To galvanize this journey, we launched Flexing Our Muscles, an initiative centered on purpose, execution and synchronicity. It is about activating our collective strength, recognizing innovation and collaboration, and rising together-
a spirit exemplified by colleagues recognized as Muscle Mavericks throughout the year.
Science remained at the heart of everything we do. In 2025, we shared important new data, including the results of MAPLE-HCM, a Phase 3 clinical trial demonstrating the superiority of aficamten to metoprolol on exercise capacity in patients with
obstructive HCM-findings that may help reshape standards of care. We continued to advance clinical research across our pipeline, completing enrollment in ACACIA-HCM, progressing pediatric and extension studies, advancing COMET-HF and initiating AMBER-HFpEF. At the same time, we strengthened quality systems, governance and clinical trial integrity as we transitioned into a commercial-stage company.
Patients continue to guide our work. This year, we launched the HCM Champions program to deepen our ability to listen and learn from people living with HCM, helping inform how we serve patients beyond the clinic. We also expanded efforts to improve access to disease information through tools like EARTH-HCM, an online public health education platform, reinforcing our commitment to equitable awareness and education.
Our culture proved essential to this progress. Guided by our We > Me mindset and values-based leadership, employees demonstrated resilience, collaboration and integrity during a year of rapid growth. We strengthened compliance systems, expanded training, established AI governance and invested in leadership development and mentorship.
As our footprint has expanded, so too has the structure of this report. What began as three pillars has evolved into six interconnected sections-Science, Patients, Culture, Integrity, Communities and Operations-reflecting the breadth of our impact
We remain humbled by the opportunity to serve patients and contribute to healthier communities. While 2025 will be remembered as a milestone year, it also reflects a beginning for us. With purpose as our guide and collaboration as our strength, we look ahead with confidence and resolve to continue
performing together-and performing with purpose. Thank you for your continued support.
Robert Blum
President & Chief Executive Officer Member, Board of Directors
and responsibilities to stakeholders.
* MYQORZO was approved by the European Commission in February 2026.
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INTRODUCTION SCIENCEPATIENTS CULTURE INTEGRITY COMMUNITIES OPERATIONS APPENDIX Cytokinetics 2025 Corporate Responsibility Report
ABOUT CYTOKINETICS
Cytokinetics is a biopharmaceutical company focused on discovering, developing and commercializing first-in-class muscle activators and next-in-class inhibitors as potential treatments for people with debilitating diseases in which muscle performance is either compromised or declining.
Since operations began in 1998, we have developed unparalleled expertise that keeps us at the forefront of drug discovery and development for diseases impacting muscle performance with more than 170 publications, over 100 clinical trials and numerous issued patents. With a corporate headquarters in South San Francisco,
VISION2030
Empowering Muscle, Empowering Lives
To be the leading muscle-focused specialty biopharma company
intent on meaningfully improving
the lives of patients through
INNOVATION
Advance 2 approved products across
3 indications and 10 NMEs in our pipeline
IGNITION
Achieve broad access and rapid use of our medicines in
>15 countries throughout North America and Europe
IMPACT
Reach >100,000 patients globally with our medicines
California, Cytokinetics is currently operating in eight countries and has offices in Radnor, Pennsylvania and outside the U.S. in Dublin, Ireland and Zug, Switzerland.
Areas of Focus
Cytokinetics' research and development focuses on impacting the mechanics of muscle function with investigational medicines that may improve muscle strength, power or performance. We aspire to develop new medicines that improve patient outcomes for people living with debilitating diseases of muscle dysfunction.
global access to our innovative medicines
Cytokinetics' Vision 2030 outlines five-year strategic objectives to propel our mission.
INSPIRATION
Foster a patient-centric culture with emphasis on equitable access
INGENUITY
Extend leadership in muscle biology deploying multiple therapeutic modalities
$88.0M
at-a-glance
REVENUE IN 2025
$416M
R&D INVESTMENT IN 2025
670+
EMPLOYEES
170+
PUBLICATIONS
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CLINICAL TRIAL PROGRAMS
4
OFFICE LOCATIONS
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INTRODUCTION SCIENCEPATIENTS CULTURE INTEGRITY COMMUNITIES OPERATIONS APPENDIX Cytokinetics 2025 Corporate Responsibility Report
Culture and Values
Cytokinetics' award-winning culture is driven by four values that guide everything we do, every day. They are:
Working together to meet the moment Flexing Our Muscles is a company-wide unifying campaign designed to strengthen organizational readiness at
a pivotal stage of growth and transformation. As the company advances toward its Vision 2030 goals and
Muscle Mavericks embody the innovation, tenacity and collaboration that will carry us forward."
ROBERT BLUM
PRESIDENT & CHIEF EXECUTIVE OFFICER
Patients are our North Star
We seek to understand our patients' journeys, and proactively embed their needs in our goals, priorities, business and community partnerships
We keep the patient front and center in all we do; all actions and decisions are in service of the patient and their caregivers
We advocate for the patient through our engagement in patient-centric activities like fundraising events, public policy initiatives, volunteering and education
We > Me
We are stronger as a team, valuing the power of diversity and rising together as one
We insist on transparency, collaboration and feedback
We champion integrity, ethics, doing the right thing and being our best selves
Science is in our soul
We are committed to robust scientific thinking, grounded in integrity and critical thinking, and not polluted by politics or divisiveness
We invite healthy debate, test hypotheses, encourage independent thought and courageously explore the unknown-all in service of improving patient health and humanity
We are problem solvers-we push boundaries and think beyond the norm to come up with out-of-the-box solutions that make a difference
Make it happen
We are tenacious and resilient, confidently navigating ambiguity to deliver results
We demonstrate courage by taking calculated risks, failing fast and recovering quickly
We hold ourselves accountable for our actions without excuses or blame
prepared for its first-ever approved commercial launch, the initiative unites more than 500 employees across functions to align around shared priorities, evolving ways of working with a heightened responsibility to patients and communities.
The initiative is built around three integrated strengths:
Strength in Purpose (Heart) grounds the organization in why the work matters, reinforcing a shared commitment to delivering meaningful impact for patients.
Strength in Execution (Mind) sharpens how work gets done, emphasizing rigor, accountability, and continuous improvement as the company scales.
Strength in Synchronicity (Heart-Mind) aligns teams across the enterprise, enabling collaboration, adaptability, and coordinated progress.
By investing in its people and culture, the company is building a resilient, values-driven organization prepared not only for a landmark product launch, but for sustained long-term growth.
Flexing Our Muscles is embedded into everyday work life through events, visual touchpoints, branded apparel, and ongoing internal communications. Highlighting 'Muscle Mavericks' provides recognition and reward for those excelling in these strengths.
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INTRODUCTION SCIENCEPATIENTS CULTURE INTEGRITY COMMUNITIES OPERATIONS APPENDIX Cytokinetics 2025 Corporate Responsibility Report
CORPORATE RESPONSIBILITY GOVERNANCE
We have built a corporate responsibility (CR) governance structure to support accountability for environmental and sustainability matters as the company grows. The Board of Directors provides oversight through the Nominating and Governance Committee.
Materiality
Our sustainability materiality matrix, most recently updated in 2024, identifies topics most relevant to our business and stakeholders. Developed through industry benchmarking, stakeholder interviews, and engagement with senior leadership and the Board, it informs priority-setting, corporate responsibility disclosures, and decision-making.
Board of Directors
CEO
Nominating & Governance
Committee
SVP of Corporate Affairs
Corporate Responsibility
The Cytokinetics Corporate Responsibility Committee-chaired by our Senior Vice President of Corporate Affairs-includes functional leaders and subject matter experts from across the company including Human Resources; Legal; Medical and Clinical; Facilities; Commercial; Compliance; Patient Advocacy; Global Supply Chain and Technical Operations; Regulatory; and Research and Development (R&D). The CR Committee provides regular updates to the CEO and Board about our corporate responsibility activities, priorities and overall strategy.
To inform our corporate responsibility planning and disclosures, we look to our stakeholders and third-party frameworks, including Sustainability Accounting Standards Board (SASB) guidelines for our industry and the Global Reporting Initiative (GRI). We have
Corporate governance
RELEVANCE TO STAKEHOLDERS
Higher Priority
Climate change risk management Emissions
Access to effective and safe medicines Diversity in clinical trials
Ethics, quality and compliance Human capital management Patient advocacy
Rigorous science and innovation
Waste Water
Community engagement Data security and privacy
Representation, empowerment, mutual respect Employee health and safety
Equity in health outcomes Sustainable supply chain
Priority
Committee
included an index of responsive disclosure with SASB and GRI at the end of this report.
Priority
IMPORTANCE TO THE BUSINESS
Higher Priority
Patients and Innovation People Governance and Integrity Environment Community
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INTRODUCTION SCIENCEPATIENTS CULTURE INTEGRITY COMMUNITIES OPERATIONS APPENDIX Cytokinetics 2025 Corporate Responsibility Report
Alignment with the United Nations Sustainable Development Goals
The United Nations Sustainable Development Goals (SDGs) are seventeen global objectives aimed at addressing challenges such as poverty, health and climate change. We reference select SDGs to illustrate how our corporate responsibility priorities align with broader global sustainability topics relevant to our business. Below are some of the ways we are working toward the goals most relevant to our business.
Improving health outcomes is at the heart of Cytokinetics' mission, propelling our research and innovation to address unmet needs
Our patient-centric approach of listening to and learning from those living with debilitating diseases guides us in developing potential treatments
Our wellness focus for employees and associated benefits support their health and well being
Our inclusion and belonging initiatives and corporate policies are designed to support equitable leadership development and fair compensation practices across the organization
Cytokinetics supports science education and career opportunities for young people
For more than 25 years, Cytokinetics has grown steadily, supporting workforce development and long-term employment as the company has expanded
Cytokinetics' financial stewardship over decades contributes to the economic development and vitality of communities in which we operate
In our offices and labs, we seek ways to minimize and eliminate waste and resource consumption by examining and optimizing materials and processes
Our clinical and commercial supply chain is built on strategic partnerships with vendors that are expected to meet defined standards related to quality, ethics, and responsible business practices
An integrated approach
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work is carried out in practice. As the company has grown, our reporting has evolved from three foundational pillars to a six-chapter structure-Science, Patients, Culture, Integrity, Communities and Operations-providing clearer alignment with our expanding footprint and making our disclosures more accessible and easier to navigate.
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This integrated framework is supported by cross-functional task forces that bring
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together diverse expertise to address complex challenges. Examples include collaboration among supply chain, regulatory and quality teams to establish the Dublin Center of Excellence, and the Equity in Cardiovascular Disease working group, which includes
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patient advocacy and compliance. C
By working across functions and disciplines, we embed responsibility into how decisions are made-strengthening accountability, advancing impact and ensuring our strategy reflects the needs of all stakeholders."
COLLEEN HEALY
SENIOR DIRECTOR, PROFESSIONAL SOCIETY RELATIONS
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INTRODUCTION SCIENCEPATIENTS CULTURE INTEGRITY COMMUNITIES OPERATIONS APPENDIX Cytokinetics 2025 Corporate Responsibility Report
2025
MYQORZO™ (aficamten) was approved by the
U.S. Food and Drug Administration for
the treatment of adults with symptomatic obstructive hypertrophic cardiomyopathy (oHCM) to improve functional capac ity and symptoms
The China National Medical Products Administration approved MYQORZO® (aficamten) for the treatment of adults with NYHA class II-III oHCM to improve exercise capacity and symptoms
Presented primary MAPLE-HCM
The Committee for Medicinal Products for Human Use of the European Medicines Agency adopted a positive opinion recommending EU marketing authorization for aficamten in symptomatic oHCM
Established a Global Supply Chain and Quality Operations Center of Excellence in Dublin to support U.S., Europe and China product launches and enable
global scale operations
Hosted the second annual CLIMB Symposium convening scientists and emerging professionals to advance interdisciplinary dialogue in cardiac and skeletal muscle biology
Continued enrolling patients in CEDAR-HCM (Clinical Evaluation of Dosing with Aficamten to
Reduce Obstruction in a Pediatric Population in HCM) evaluating aficamten in pediatric obstructive hypertrophic cardiomyopathy, with adolescent enrollment expected into 2026
RECRUITED, HIRED AND ONBOARDED CARDIOVASCULAR ACCOUNT SPECIALISTS WITH RARE DISEASE
AND CARDIOVASCULAR EXPERIENCE TO SUPPORT HEALTHCARE PROFESSIONALS AND NEW PATIENT STARTS
Cited by Fortune magazine as a "Best Workplace in BioPharma" and "Best Workplace
in the Bay Area" for a fourth consecutive year
Continued conduct of
Certified as "Great Place to Work" for a fourth consecutive year
Recognized by the San Francisco Business Times as a "Best Place to Work in the Bay Area" for the fifth consecutive year
Continued conduct of AMBER-HFpEF (Assessment of CK-586 in a Multi-Center, Blinded Evaluation of Safety and Tolerability Results in HFpEF), a Phase 2 clinical trial of ulacamten in patients with symptomatic heart
failure with preserved ejection fraction
Designed MYQORZO & You™, a comprehensive patient support program paired with the MYQORZO REMS
Program to support treatment initiation
and ongoing monitoring
(Metoprolol vs Aficamten in Patients with LVOT Obstruction on Exercise Capacity in HCM)
124
EMPLOYEES IN MENTOR-MENTEE PAIRS DURING
COMET-HF (Confirmation of Omecamtiv Mecarbil Efficacy Trial in Heart
LAUNCHED THE HCM CHAMPIONS PROGRAM TO CREATE A SCALABLE, COMPLIANT
AND EMOTIONALLY RESONANT WAY FOR
Phase 3 clinical trial results at ESC Congress 2025
demonstrating superiority of aficamten to metoprolol on peak oxygen uptake and five secondary endpoints
INAUGURAL SIX-MONTH CYCLE OF CYTO EXCHANGE, A COMPANY-WIDE MENTORSHIP PROGRAM
Failure), a confirmatory
Phase 3 clinical trial of omecamtiv mecarbil in patients with severe heart failure with enrollment expected through 2026
PATIENTS, CAREGIVERS AND ADVOCATES TO CONNECT AND ENGAGE WITH EMPLOYEES AND EACH OTHER
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SCIENCE
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PATIENTS CULTURE INTEGRITY COMMUNITIES OPERATIONS APPENDIX
Cytokinetics 2025 Corporate Responsibility Report
SCIENCE
NEW RESEARCH PUBLICATIONS
55
SCIENCE PRESENTATIONS
Science is foundational to Cytokinetics' mission and shapes how we operate across the organization-from discovery through clinical evaluation, strategic decision-making and stakeholder education.
KEY ACCOMPLISHMENTS
Received approval of MYQORZO™ (aficamten) for treatment of oHCM in the U.S. and China and a positive opinion from the Committee for Medicinal Products for Human Use of the European Medicines Agency
Successfully completed global regulatory inspections
Announced positive results of MAPLE-HCM
Our innovation is rooted in a deep understanding of muscle biology and a commitment
to addressing unmet patient needs. In service of our Vision 2030, we are progressing our pipeline by translating causal human biology into targeted, data-driven development programs, supported by new modalities, partnerships
and technologies. Quality systems span the full lifecycle,
reliability and continuous improvement across clinical and commercial programs. We strive to reflect diverse patient populations in clinical trials, supported by robust oversight to maintain integrity and transparency.
By integrating scientific rigor, quality management and ethical conduct at every stage of our research, development and commercial operations,
2026 PRIORITIES
File Supplemental New Drug Application (sNDA) for aficamten based on MAPLE-HCM
Advance six ongoing clinical stage programs including three with active enrollment
Pursue discovery of at least two investigational new drugs (INDs) to enter clinic in 2027
Develop and enact diversity plans as integral part of clinical trial design
designed to drive consistency,
MATERIAL TOPICS
Rigorous science and innovation Diversity in clinical trials
we reinforce trust. IN THIS SECTION
Research and Development
Muscle-Directed Medicines
Product Quality and Safety
Clinical Trials
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INTRODUCTION SCIENCE PATIENTS CULTURE INTEGRITY COMMUNITIES OPERATIONS APPENDIX Cytokinetics 2025 Corporate Responsibility Report
RESEARCH AND DEVELOPMENT
Our research and development strategy integrates cutting-edge science with patient-centric principles.
Collaboration is a cornerstone of our innovation. Cytokinetics partners with academic institutions, biotechnology companies and patient advocacy groups to accelerate discovery and align our therapies with patient needs. Through our Patient and Caregiver Advisory Councils, we gain invaluable insights into disease impact and treatment priorities, shaping our clinical trial designs and endpoints.
Our commitment to innovation extends into every phase of development. We employ adaptive trial designs, leverage real-world evidence and develop validated patient-reported outcome measures (PROMs) to evaluate how our therapies improve patients' lives. Transparency and data-driven decision-making guide our pipeline, supporting efficient resource allocation and maximum therapeutic potential.
Advancing a specialty cardiovascular development pipeline
Our deep understanding of muscle biology enables us to develop potential therapies targeting muscle contractility, performance and fatigue. By focusing on the mechanism of muscle dysfunction at a molecular level, we are advancing treatments that address unmet medical needs in cardiovascular diseases. We employ advanced technologies to design small molecule therapeutics that modulate muscle proteins. This approach has led to the development of investigational drugs for conditions like hypertrophic cardiomyopathy (HCM) and heart failure.
AI-enabled discovery
We have begun leveraging artificial intelligence across research functions to enhance productivity, expand ideation and support hypothesis generation.
Early applications in chemistry and structure-activity relationship modeling have demonstrated the potential of AI-enabled tools to surface novel insights, accelerate decision-making and free scientists to focus on creative and strategic work.
Empowering ingenuity
Looking ahead, Cytokinetics is intentionally balancing internally generated innovation with external opportunities, guided by clear scientific criteria and responsible capital allocation. We are prioritizing programs that can advance toward clinical entry over the coming years, including continued investment in contractility science and exploration of new modalities such as protein degradation.
Cytokinetics' R&D approach exemplifies how scientific rigor and patient focus can drive meaningful progress. By addressing the root causes of muscle dysfunction and collaborating across disciplines, we are redefining possibilities in muscle biology and advancing therapies with the potential to transform lives.
Research sits at both the beginning and the end of our work-
driving discovery and preclinical development while also supporting education and collaboration across medical, regulatory and commercial teams."
AJAY CHAWLA
VICE PRESIDENT, BIOLOGY
Publishing our research Cytokinetics scientists are committed to high scientific and ethical publications standards and to providing our science to the medical and scientific community through peer-reviewed journals and medical forums.
In 2025, Cytokinetics authors and research teams advanced the field with a remarkable body of scientific work, sharing discoveries across clinical, translational and real-word research. This year we achieved 28 manuscripts accepted or published along with 41 abstracts submitted and 55 presentations delivered at major scientific congresses.
These publications contribute to a growing evidence base to help educate physicians about potential treatments. We also publish Plain Language Summaries (PLS) of our trials, written in clear, non-technical language to explain trial designs and outcomes for participants and stakeholders.
View publications at
cytokinetics.com/publications
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INTRODUCTION SCIENCE PATIENTS CULTURE INTEGRITY COMMUNITIES OPERATIONS APPENDIX Cytokinetics 2025 Corporate Responsibility Report
From Research to Far-Reaching Impact
In December 2025, Cytokinetics reached a defining milestone with the approval of MYQORZO™ (aficamten), marking the company's first commercial medicine and the culmination of years of focused scientific effort.
Approved by the U.S. Food and Drug Administration for adults living with symptomatic obstructive hypertrophic cardiomyopathy (oHCM), MYQORZO offers patients a new treatment option designed to improve daily functioning and quality of life. Approval by the China National Medical Products Administration was received in December 2025, followed by approval from the European Commission in February 2026.
For people living with oHCM, symptoms such as shortness of breath, fatigue and limited physical capacity can profoundly affect everyday activities. MYQORZO was developed
to address the underlying cause of obstruction in the heart, helping patients feel and function better. Cytokinetics is supporting patients through MYQORZO & You™,
a personalized program that provides education, treatment navigation and assistance with insurance and financial support.
For far too long, we've had few options to address our needs, and the approval of MYQORZO is a long-awaited and major addition to bring new hope to patients living with oHCM."
LISA SALBERG
FOUNDER AND CEO OF THE HYPERTROPHIC CARDIOMYOPATHY ASSOCIATION (HCMA)
In the United States, MYQORZO™ (aficamten) is available in 5 mg, 10 mg, 15 mg, 20 mg tablets with access through a Risk Evaluation and Mitigation Strategy (REMS) Program, which includes monitoring requirements for patients and certification for prescribers and pharmacies.
2018
2020
2021
2022
2023
2024
2025
2026
Initiated Phase 1 study
Initiated REDWOOD-HCM,
Received orphan drug
Started SEQUOIA-HCM
Started MAPLE-HCM, a
Initiated CEDAR-HCM, a
Received FDA Approval of
First patients prescribed
of aficamten
a Phase 2 clinical trial
designation for aficamten
a Phase 3 clinical trial of
Phase 3 clinical trial of
Phase 3 clinical trial of
MYQORZO™ (aficamten)
and ongoing clinical trials
of aficamten
for the treatment of HCM
aficamten in oHCM
aficamten in oHCM
aficamten in a pediatric
for the treatment of adults
of aficamten
Started FOREST-HCM, an open-label extension study of aficamten (ongoing)
Announced results of REDWOOD-HCM, a pivital Phase 2 clinical trial of aficamten in HCM
Began Phase 2 cohort 4 of REDWOOD-HCM clinical trial of aficamten in nHCM
Started ACACIA-HCM, a Phase 3 clinical trial of aficamten in nHCM (ongoing)
Announced positive results of SEQUOIA-HCM, the
pivotal Phase 3 clinical trial
population with oHCM (ongoing)
FDA accepted New Drug Application for aficamten in oHCM
with symptomatic oHCM to improve functional capacity and symptoms
of aficamten in oHCM
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INTRODUCTION SCIENCE PATIENTS CULTURE INTEGRITY COMMUNITIES OPERATIONS APPENDIX Cytokinetics 2025 Corporate Responsibility Report
Science is in Our Soul Day 2025
In October 2025, Cytokinetics held its third annual Science is in Our Soul Day (SIIOSD), celebrating how every department applies scientific thinking to advance the company's mission. The event featured
both in-person and virtual poster sessions highlighting work across disciplines, including clinical and pre-clinical research, scientific publication planning, patient centricity, grants and corporate giving.
Participation continued to grow year over year, with virtual slide presentations more than doubling-from eight to eighteen-reflecting the company's commitment to inclusivity for remote employees. Nearly 100 posters were presented, and for the first time, newly hired Cardiovascular Account Specialists joined the afternoon session, strengthening cross-functional connections and welcoming them into Cytokinetics' research-driven culture.
POSTERS PRESENTED
99
18
VIRTUAL POSTERS
This event provides a unique opportunity for all employees to come together, connect, learn from one another and celebrate the work we do."
NARSIMHA MUNAGALA ASSOCIATE DIRECTOR, TRANSLATIONAL BIOLOGY
SIIOSD exemplifies Cytokinetics' commitment to our core values as a company, always keeping science and patients at the forefront of everything we do."
RICKY SIDHU SENIOR MANAGER,
SCIENTIFIC COMMUNICATIONS
Along with poster presentations, the 2025 event included a ribbon-cutting ceremony for a new Discovery Gallery at our South San Francisco office. Part art gallery and part science museum, the new space (shown bottom right) blends artifacts, photos, stories, and digital media into an immersive storytelling experience about Cytokinetics' history.
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INTRODUCTION SCIENCE PATIENTS CULTURE INTEGRITY COMMUNITIES OPERATIONS APPENDIX Cytokinetics 2025 Corporate Responsibility Report
A COMMITMENT TO MUSCLE-DIRECTED MEDICINES
Approved
in US, China & EU**
Therapeutic Area
(Clinical Trial)
Drug Candidate
Research
Pre-Clinical
Phase 1
Phase 2
Phase 3
Approved & Commercialized
MYQORZO®*
oHCM
SEQUOIA-HCM
Aficamten
oHCM (vs. metoprolol)
MAPLE-HCM
Aficamten
Pediatric oHCM
CEDAR-HCM
Aficamten
nHCM
ACACIA-HCM
Ulacamten
HFpEF
AMBER-HFpEF
Omecamtiv Mecarbil
HFrEF
COMET-HF
Cytokinetics has one approved medicine, six clinical-stage programs and ongoing research in muscle function, contractility, energetics and metabolism.
Ph3 topline results expected Q2 '26
CK-089
Clinical-stage programs are focused on cardiovascular conditions including: hypertrophic cardiomyopathy (HCM), a progressive condition that causes the heart to thicken and stiffen, eventually limiting its ability to pump blood; and heart failure (HF), a progressive condition in which the heart becomes enlarged, thickened or rigid, hindering its ability to pump blood throughout the body.
Our long-term commitment to understanding the basic biology of muscle cell function and our
steadfast relationships with patient advocates have inspired us to build a pipeline of disease-modifying drugs to improve
patients' lives."
STUART KUPFER, M.D. SENIOR VICE PRESIDENT, CHIEF MEDICAL OFFICER
Muscular Dystrophy, other
Muscle Biology Directed
Research
*Please see full Prescribing Information, including Boxed WARNING and Medication Guide
**MYQORZO is only approved in the U.S., China and the EU for the treatment of adults with symptomatic oHCM.
Ulacamten, omecamtiv mecarbil and CK-089 are investigational agents and have not been approved for use by any regulatory agency. Their safety and efficacy has not been established.
oHCM: obstructive hypertrophic cardiomyopathy nHCM: non-obstructive hypertrophic cardiomyopathy HFpEF: heart failure with preserved ejection fraction HFrEF: heart failure with reserved ejection fraction EC: European Commission
sNDA: Supplemental New Drug Application
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APPROVED MEDICINE ONGOING RESEARCH
Aficamten
MYQORZO™ (aficamten) is an allosteric and reversible inhibitor of cardiac myosin motor activity.
MYQORZO is approved by the U.S. FDA, the China National Medical Products Administration and European Commission for the treatment of symptomatic obstructive hypertrophic cardiomyopathy (oHCM) to improve functional capacity and symptoms in adult patients.
In patients with HCM, myosin inhibition with MYQORZO reduces cardiac contractility and left ventricular
outflow tract (LVOT) obstruction. MYQORZO was engineered to achieve a predictable exposure response, rapid onset of action and reversibility.
MYQORZO (aficamten) is only approved in the U.S., China and the EU for oHCM.
In May 2025, Cytokinetics announced positive topline results from MAPLE-HCM (Metoprolol vs Aficamten in Patients with LVOT Obstruction on Exercise Capacity in HCM), a Phase 3 clinical
trial evaluating aficamten as monotherapy compared with metoprolol, a commonly prescribed beta blocker, in patients with symptomatic obstructive hypertrophic cardiomyopathy (oHCM). The study met its primary endpoint, demonstrating a statistically significant improvement in peak oxygen uptake (pVO2) at Week 24 with aficamten compared
to metoprolol. Aficamten also demonstrated a favorable safety and tolerability profile. MAPLE-HCM enrolled 175 patients in a randomized, double-blind design, with participants eligible to continue into the open-label extension study, FOREST-HCM.
Aficamten is also under clinical investigation in ACACIA-HCM (Assessment Comparing Aficamten to Placebo on Cardiac Endpoints In Adults with Non-Obstructive HCM), a Phase 3 clinical trial in patients with non-obstructive HCM (nHCM) and CEDAR-HCM (Clinical
Evaluation of Dosing with Aficamten to Reduce Obstruction in a Pediatric Population in HCM), a Phase 3 clinical trial in a pediatric population with oHCM. Aficamten has not been deemed safe or effective for use in either of these patient populations. In addition, aficamten
is being studied in FOREST-HCM (Follow-up, Open-Label, Research Evaluation of Sustained Treatment with Aficamten in HCM), an open-label extension clinical study.
EARTH-HCM (Epidemiology, Awareness,
Real-world Treatment and Health Outcomes in HCM) is an open access, public health education tool developed by Cytokinetics
in collaboration with experts from leading research institutions. The interactive online platform uses real-world data to visualize the geographical distribution of HCM in the U.S., offering an innovative, user-friendly way for a wide audience of patients, clinicians, pharmacists, researchers, policy decision-
makers and patient advocacy groups to learn about HCM. The resource has served as the basis for a recent journal publication, with an update planned for 2026 and the potential to integrate data for regions outside the U.S.
EARTH-HCM aims to advance research, uncover knowledge gaps and investigate disparities in care, ultimately promoting more equitable access, not just for our company, but for the entire HCM community."
SANATAN SHREAY, PH.D.
EXECUTIVE DIRECTOR, HEAD OF HEALTH ECONOMICS AND OUTCOMES RESEARCH
WHAT IS HCM?
Hypertrophic Cardiomyopathy HCM is a genetic disease in
which the heart muscle becomes abnormally thick (hypertrophies) and stiffens, eventually limiting its ability to pump blood. This ultimately limits the heart's pumping function, resulting in reduced exercise capacity and symptoms including chest pain, dizziness, shortness of breath or fainting during physical activity.1,2 An estimated two-thirds of HCM patients have obstructive HCM (oHCM), in which the thickening
of the cardiac muscle leads to left ventricular outflow tract (LVOT) obstruction; one-third have non-obstructive HCM (nHCM), in which blood flow is not impacted but the heart muscle is still thickened.
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INVESTIGATIONAL MEDICINES
Omecamtiv mecarbil
Omecamtiv mecarbil is an investigational, selective, small molecule cardiac myosin activator, the first of a novel class of myotropes designed to directly target the contractile mechanisms of the heart, binding to and recruiting more cardiac myosin heads to interact with actin during systole. In doing so, omecamtiv mecarbil augments the impaired contractility that is associated with heart failure with reduced ejection fraction (HFrEF).
Omecamtiv mecarbil was the subject of a positive Phase 3 clinical trial, GALACTIC-HF (Global Approach to Lowering Adverse Cardiac Outcomes Through Improving Contractility in Heart Failure), in patients with HFrEF. The magnitude of the treatment effect in a pre-specified subgroup of more than 4,500 patients with heart failure with severely reduced ejection fraction (<30%) was observed to be greater than in the overall drug treated population of GALACTIC-HF.
Building on the results of GALACTIC-HF, Cytokinetics has initiated COMET-HF (Confirmation of Omecamtiv Mecarbil Efficacy Trial in Heart Failure), a confirmatory Phase 3 clinical trial
to assess the efficacy and safety of omecamtiv mecarbil in patients with symptomatic heart failure with severely reduced ejection fraction. COMET-HF is being conducted in collaboration with Duke Clinical Research Institute (DCRI) and is enrolling 1,800 patients to evaluate the impact of omecamtiv mecarbil on extending time to cardiovascular death, heart failure events or advanced interventions such as left ventricular assist device (LVAD) implantation or cardiac transplantation. Participants will receive omecamtiv mecarbil or placebo until 850 key events occur. Enrollment began in December 2024 and continued throughout 2025.
WHAT IS HFrEF?
Heart Failure with Severely Reduced Ejection Fraction Heart failure is a grievous condition that affects more than 64 million people worldwide3 about half of whom have reduced left ventricular function.4,5 It is the leading cause of hospitalization and readmission in people age 65 and older.6,7 By 2029 is it estimated that 2.8 million people in the U.S. will have heart failure with severely reduced ejection fraction8, characterized as heart failure with reduced ejection fraction (HFrEF)
<30%, and 840,000 people will have
severely reduced ejection fraction with other features indicative of high risk heart failure.9 Patients with high risk heart failure with severely reduced ejection fraction account for approximately 60% of all HFrEF
hospitalizations, with 35% of patients re-hospitalized within a year.10,11
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INVESTIGATIONAL MEDICINES
Ulacamten (CK-586)
This investigational, novel, selective, oral, small molecule cardiac myosin inhibitor
is designed to reduce the hypercontractility associated with heart failure with preserved ejection fraction (HFpEF).
In preclinical models, ulacamten reduced cardiac hypercontractility by decreasing the number
of active myosin cross-bridges during cardiac contraction, thereby reducing the contractile force, without effect on calcium transients.
Ulacamten was evaluated in a Phase 1 study assessing the safety, tolerability and
pharmacokinetics of single and multiple oral doses of ulacamten. Ulacamten is now the subject of AMBER-HFpEF (Assessment of CK-586 in
a Multi-Center, Blinded Evaluation of Safety and Tolerability Results in HFpEF), a Phase 2 clinical trial in a subgroup of patients with symptomatic
HFpEF with hypercontractility and ventricular hypertrophy.
WHAT IS HFpEF?
Heart Failure with Preserved Ejection Fraction
HFpEF is a condition where the heart pumps normally but struggles to relax and fill properly, leading
to symptoms like shortness of breath, fatigue and swelling in the legs. Unlike other types of heart failure, the heart's pumping ability, measured by ejection fraction, remains normal (≥50%). HFpEF is common in older adults and often linked to conditions like high blood pressure, obesity and diabetes. The stiffened heart muscle cannot relax well, causing increased pressure and fluid buildup. Diagnosis involves tests like echocardiograms and blood biomarkers (e.g., NT-proBNP). Despite the availability of therapies, patient symptoms are not currently well managed.
The Sarcomere:
the fundamental unit of muscle contractility
The principal functionality of muscle is rooted in its ability to contract and relax. The foundation for muscle contraction is the sarcomere, found in all muscle cells. Sarcomeres contain a motor
protein called myosin, which powers the muscle to contract by "grabbing" onto another protein called actin and "flexing." When the myosin releases the actin, the muscle relaxes. This process is regulated by another protein called troponin.
Sarcomere malfunctions that cause decreased or increased contractility of the muscle play a central role in diseases like heart failure with reduced ejection fraction and HCM, respectively. Therapies with the potential to modulate sarcomere function may improve the lives of patients suffering from these diseases.
Cytokinetics' research is focused to modulating proteins in the sarcomere, the fundamental unit of muscle contraction found within muscle cells.
These crucial proteins are the keys to unlocking the potential treatment of diseases that are caused by impaired muscle function.
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CLIMB Research Symposium 2025
Cytokinetics hosted its second annual Contemporary Landscapes in Muscle Biology Research Symposium (CLIMB) in May 2025, convening scientists, researchers and emerging professionals at the Mission Bay Conference Center in San Francisco.
The one-day symposium aims to foster collaboration, facilitate networking opportunities and promote interdisciplinary dialogue, with the ultimate goal of driving advancements in the biological understanding and emerging treatment of muscle-related diseases and disorders. CLIMB doubled registration from its
inaugural year and featured a program of distinguished expert speakers and novel research posters focusing on innovations in cardiac biology, skeletal muscle biology and emerging treatment modalities in muscle biology. Participants praised the event's scientific caliber and collaborative spirit.
CLIMB was born out of our vision to bring together key contributors in muscle biology across academia and industry to foster meaningful scientific exchange and showcase novel research."
FADY I. MALIK, M.D., PH.D., EXECUTIVE VICE PRESIDENT OF RESEARCH & DEVELOPMENT
ATTENDEES
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SPEAKERS
POSTER PRESENTATIONS
The symposium was fantastic-a testament to Cytokinetics' leadership in innovation and forward thinking. The breadth of speakers was a perfect balance."
ROBIN M. SHAW, M.D., PH.D.
DIRECTOR, NORA ECCLES HARRISON CARDIOVASCULAR RESEARCH AND TRAINING INSTITUTE
PROFESSOR OF MEDICINE, UNIVERSITY OF UTAH
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PRODUCT QUALITY AND SAFETY
The Cytokinetics quality assurance program, overseen by the Chief Legal and Administrative Officer, provides a structured framework for training, governance, and performance monitoring to support product quality and patient safety. The activities of our Quality Team span R&D, clinical trials, supply chain and technical operations.
Quality Management System
2025 QUALITY HIGHLIGHTS
As Cytokinetics transitioned from a research-focused organization to a commercial-stage company, expectations for compliance, rigor and execution increased
significantly. This evolution required heightened accountability at every level. Processes must be consistent, robust, reliable and repeatable; once systems are validated, they must perform without deviation.
With a top priority of achieving
Successfully hosted global regulatory inspections, including those conducted by the FDA, the California Board of Pharmacy and the EMA, as well as inspections at clinical sites across China, the United States and Europe. Each inspection concluded successfully, marking a significant milestone as the company navigated this level of global regulatory oversight for the first time.
Established the Dublin, Ireland office as a European hub for supply chain, technical operations, and quality. The site houses Cytokinetics' Qualified Persons (QPs), who will release commercial batches globally, and reflects the evolution to a fully integrated global quality system supporting multiple markets. (See Center of Excellence, page 42)
Expanded enterprise quality systems to support global commercializa-
Our Quality Management System (QMS) is designed to support adherence to global regulations, ICH guidelines and internal standards, as well as assure that our products meet specified identity, strength, purity and safety requirements.
The Cytokinetics Quality Manual is the foundation of our QMS. Employees are expected to complete onboarding and annual training on the quality manual. The quality manual provides guidance on maintaining patient protection and data integrity in clinical trials, clinical and commercial product quality, product safety, compliance and continuous improvement systems and processes.
Our electronic QMS platform includes robust reporting and risk management, supporting a proactive approach to identifying, assessing and controlling deviations with mechanisms for escalating issues to the appropriate level. Our internal audit program includes annual audits for Good Clinical
Practice (GCP) and Good Manufacturing Practice (GMP) operations. External partners and vendors must also align with our quality requirements, verified through audits and quality agreements. For clinical trials, we employ continual safety and stringent quality monitoring.
Quality is the responsibility of all personnel, with expectations and requirements across levels from employees and contractors, through senior
management. Monthly GCP Compliance Committee meetings, as well as monthly quality forums, facilitate cross-functional discussions on quality issues and ongoing assessment of our QMS. Quarterly Quality Management Review Boards, attended by senior leadership including the CEO and Chief Medical Officer (CMO), provide a platform for regular evaluation of the effectiveness of our QMS, escalation of potential quality issues, and to assess appropriate resource allocation. The CEO is accountable for Cytokinetics' overall adherence to the QMS.
readiness to launch a high-quality, compliant product on time, here are some of the ways we advanced quality at Cytokinetics in 2025.
We've built a strong quality management framework with a culture of continuous
improvement and transparent governance-all to build stakeholder trust
and operational excellence."
MEGAN TRUONG
VICE PRESIDENT, QUALITY
tion, including GMP compliance, supplier qualification and capabilities to manage recalls, complaints and quality oversight across regions.
Enhanced training programs to further embed a culture of quality across the organization. Efforts expanded beyond online policy training to include instructor-led sessions and interactive workshops on GMP and GCP topics, with plans in 2026 to introduce additional on-the-job training and a train-the-trainer model.
Strengthened oversight of third-party contract manufacturers, recognizing the importance of rigorous governance in a fully outsourced manufacturing model.
Streamlined governance and reporting structures to establish clear channels for KPIs and performance metrics, providing leadership with consistent, timely visibility to support oversight and decision-making.
Celebrated World Quality Day for a third consecutive year, engaging teams across the organization to highlight the role of quality in their work and reinforce a shared culture of excellence.
Looking ahead to 2026, the focus shifts from new program implementation to continuous improvement-optimizing and maturing the systems and processes in place.
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Maintaining ethical conduct in clinical trials is a core commitment, guided and overseen by our Chief Medical Officer and Senior Vice President of Development Operations. We strive to adhere to policies aligned with international standards, including the International Council for Harmonisation (ICH), Good Clinical Practice (GCP) guidelines, and applicable regional regulations, helping to ensure trials are conducted responsibly and transparently.
Applying AI thoughtfully in clinical trial operations Artificial intelligence holds transformative potential to enhance the speed, precision and scalability of modern clinical trials. Cytokinetics is beginning to integrate AI tools into select areas of clinical trial operations to support data quality, efficiency and insight generation. These tools are designed to assist-not replace-expert judgment, and are expected to be used under defined processes and governance.
One early application supports medical coding, where large volumes of free-text clinical data, such as adverse event descriptions, must be translated into standardized medical terminology. AI tools can perform
Compliance with GCP and other Good Practice (GxP) standards protects participants' rights, safety and well-being while supporting the generation
of reliable clinical trial data. Institutional Review Boards (IRBs) and independent Ethics Committees oversee trial ethics and are authorized to approve, require modifications to, or terminate studies at affiliated institutions. Key documents, including study protocols and informed consent forms, must undergo rigorous review by IRBs, Ethics Committees and health authorities.
Patient safety is prioritized through ongoing data review by internal monitors and specialized oversight bodies. These include Drug Safety Committees for Phase 1 studies and independent Data Monitoring Committees for larger trials, which periodically evaluate clinical data to identify potential safety concerns and recommend appropriate actions.
Patient input also plays an important role in trial design and execution. We engage patients through participation on Steering Committees for our key clinical trials and, when feasible, provide post-trial access to investigational medicines, including open-label extension (OLE) studies for Phase 3 clinical trials, to support continuity of care.
Following product launch, we plan to generate additional evidence through a coordinated, post-launch evidence strategy that includes studies using patient registry and real-world data. These efforts are designed to responsibly assess how medicines are used in routine clinical practice, deepen understanding of patient populations and
inform future research while maintaining appropriate scientific and ethical oversight.
All clinical trials are required to be disclosed in publicly available databases, including ClinicalTrials.gov.
a first-pass review across tens of thousands of entries, accelerating early-stage work while maintaining human oversight for accuracy and regulatory compliance. Additional capabilities help flag data anomalies,
support risk-based quality monitoring and enable medical teams to more efficiently explore patient-level characteristics.
These efforts are supported by formal oversight, including a cross-functional AI governance structure, to align responsible use with quality standards, regulatory expectations and patient safety.
AI helps us manage scale and complexity, but people remain accountable for the science, the data and the decisions."
ERIC TERHAERDT SENIOR VICE PRESIDENT,
DEVELOPMENT OPERATIONS
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Clinical Trial Participation
We believe that a participant pool that is representative of the patients we aim to serve may strengthen study results, reduce treatment bias and increase confidence that a treatment may work across different demographics. As such, we proactively seek to include patients from diverse populations across backgrounds.
Additionally, the Steering Committees of the ACACIA-HCM and MAPLE-HCM clinical trials include members from the HCM patient community, investigators and academic leaders representing a broad cross-section of knowledge and experiences.
We strive to ensure our clinical research reflects the real-world patient populations affected by the diseases we study. We do this by strengthening access and building trust through partnerships with community organizations that understand and serve patients where they are."
KIMBERLY ERBY
DIRECTOR, CLINICAL OPERATIONS
Partnership spotlight:
PCNA diversity in clinical trials initiative
Cytokinetics is partnering with the Preventive Cardiovascular Nurses Association (PCNA), whose mission is to promote the role of nurses as leaders in cardiovascular disease
prevention and management. Nurses play a crucial role in building trust with patients, which is vital when it comes to clinical trial participation.
We provided funding and support for a member education campaign that supplied nurses with the tools needed to empower patients to make informed decisions about
participating in clinical trials. The impact of this education campaign is amplified as other nurse organizations extend the reach of the educational materials through their own communication channels.
We have partnered with the Association of Black Cardiologists
We have sponsored
the Global Cardiovascular Clinical Trialists Forum's
We have collaborated with advocacy partners on initiatives such as "ENACT:
We have expanded our activities globally, to attract patients from
Campaign materials include a podcast miniseries and a digital patient education resource distributed to PCNA members via social media, e-newsletter, blog posts and the association website.
on a mentorship program for emerging leaders in medicine and clinical research.
Future Trialist Fellowship and the American College of Cardiology workforce development initiative.
Empower, Navigate, Activate for Clinical Trials" with The Mended Hearts, Inc. and WomenHeart.
locales including Hawaii, China, Japan, Europe, Israel and South America.
12,000
PCNA MEMBERS
10,000
E-NEWSLETTER
SUBSCRIBERS
200
AVERAGE NUMBER
OF PCNA PODCAST DOWNLOADS
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Disclaimer
Cytokinetics Incorporated published this content on April 14, 2026, and is solely responsible for the information contained herein. Distributed via Public Technologies (PUBT), unedited and unaltered, on April 14, 2026 at 20:21 UTC.