Cytokinetics Inc Stock Price, News & Analysis

Cytokinetics (Nasdaq: CYTK) announced positive results from the Phase 1 study of CK-4021586 (CK-586), a cardiac myosin inhibitor for potential treatment of heart failure with preserved ejection fraction (HFpEF). The study met its primary and secondary objectives, demonstrating safety, tolerability, and favorable pharmacokinetics of CK-586. Key findings include:

• No serious adverse events observed
• Half-life of 14-17 hours
• Dose-linearity without change in half-life
• Predictable PK/PD relationship
• Mean decrease in LVEF <5% at highest dose

These results support advancement to a Phase 2 clinical trial in HFpEF patients, expected to begin in Q4 2024.

Cytokinetics (Nasdaq: CYTK) has announced two presentations at the 2024 American College of Clinical Pharmacology (ACCP) Annual Meeting in Bethesda, MD, scheduled from September 8-10, 2024. The first presentation, titled 'A First-in-Human, Single & Multiple Ascending Dose Study of CK-4021586, A Novel Cardiac Myosin Inhibitor', will be presented by Justin Lutz, Senior Director of Clinical Pharmacology. The second presentation, 'Clinical Evaluation of the Effect of Aficamten on QT/QTc Interval in Healthy Participants', will be delivered by Polina German, Executive Director of Clinical Pharmacology. Both presentations are scheduled for September 8, 2024, during the Opening Reception, Exhibits & Poster Session 1, from 5:00-7:00 PM ET in the Grand Ballroom E-H.

Cytokinetics (Nasdaq: CYTK) announced inducement grants to new employees on August 30, 2024. The grants include:

1. For Brett Pletcher, Executive VP and Chief Legal Officer:
- 51,039 stock options
- 33,140 restricted stock units (RSUs)
- 14,603 performance stock units (PSUs)

2. For 18 additional employees:
- 59,429 stock options
- 38,586 RSUs

The stock options have an exercise price of $57.08 per share. RSUs vest over 3 years, while stock options vest over 4 years. PSUs are subject to performance goals. These grants were made as material inducements to employment in accordance with Nasdaq Listing Rule 5635(c)(4).

Cytokinetics (Nasdaq: CYTK) has announced its participation in three major investor conferences in September 2024:

• Morgan Stanley 22nd Annual Global Healthcare Conference on September 4 at 7:45 AM ET
• H.C. Wainwright 26th Annual Global Investment Conference on September 9 at 10:30 AM ET
• Cantor Fitzgerald Global Healthcare Conference 2024 on September 18 at 9:10 AM ET

All events will take place in New York City. Live webcasts of the presentations and fireside chats will be available on the Cytokinetics website, with replays archived for 90 days after each event. This participation demonstrates Cytokinetics' commitment to investor relations and provides opportunities for the company to showcase its developments to a wide audience of healthcare investors.

Cytokinetics (CYTK) reported Q2 2024 financial results and provided updates on its cardiac muscle programs. Key highlights include:

1. Initiated rolling NDA submission for aficamten in obstructive HCM, expected to complete in Q3 2024.

2. FDA cleared protocol amendment for FOREST-HCM, reducing echocardiographic monitoring frequency.

3. Advancing preparations for a confirmatory Phase 3 trial of omecamtiv mecarbil in HFrEF, expected to start in Q4 2024.

4. Completed Phase 1 study of CK-586, planning Phase 2a trial in HFpEF for Q4 2024.

5. Q2 2024 financial results: $1.4 billion cash position, $0.2 million revenue, $143.3 million net loss.

6. Updated 2024 guidance: GAAP operating expense $555-575 million, net cash utilization $400-420 million.

Cytokinetics (Nasdaq: CYTK) has announced the granting of stock options and restricted stock units (RSUs) to 16 new employees who joined the company in July 2024. The grants, made on July 31, 2024, include:

- 44,887 shares of common stock options at an exercise price of $59.01 per share
- 29,149 RSUs to be settled into common stock upon vesting

The RSUs will vest over 3 years, with 40% vesting after the first year, 40% after the second year, and 20% after the third year. The stock options will vest over 4 years, with 1/4 vesting after the first year and the remaining shares vesting monthly over the next 36 months. These grants were made as material inducements to employment in accordance with Nasdaq Listing Rule 5635(c)(4).

Cytokinetics (Nasdaq: CYTK) has announced a call for proposals for its Corporate Giving Program. The program offers charitable donations up to $20,000 to eligible non-profit organizations in the United States. It aims to support diversity in science education, equitable healthcare initiatives for cardiovascular disease, and essential services for local and at-risk communities.

The program focuses on qualified 501(c)(3) organizations not directly involved in healthcare practice. It targets initiatives in the San Francisco Bay Area and Greater Philadelphia Region, as well as cardiovascular health equity initiatives across the U.S. The application deadline is September 16, 2024, and submissions can be made online through the company's website.

Cytokinetics (Nasdaq: CYTK) has announced that it will release its second quarter 2024 financial results on August 8, 2024, at 4:00 PM Eastern Time. Following the announcement, the company's senior management will host a conference call at 4:30 PM Eastern Time to discuss operational and financial results, as well as the company's future outlook.

Investors and interested parties can access the conference call through a simultaneous webcast available on the Investors & Media section of Cytokinetics' website. Additionally, participants can join the call via telephone by registering in advance through a provided link. An archived replay of the webcast will be accessible on the company's website for twelve months after the event.

Cytokinetics (CYTK) announced seven upcoming presentations at the European Society of Cardiology Congress 2024, including four Late Breaking Clinical Trial presentations on aficamten. The presentations will cover:

1. Effect of aficamten on patient-reported health status in obstructive hypertrophic cardiomyopathy (SEQUOIA-HCM)
2. Impact of aficamten on echocardiographic cardiac structure and function
3. Effect of aficamten on structure and function (SEQUOIA-HCM CMR Substudy)
4. Safety and outcomes of standard of care medications withdrawal (FOREST-HCM Trial)
5. Clinical application of biomarkers in obstructive hypertrophic cardiomyopathy (SEQUOIA-HCM)
6. Integrated safety analysis of aficamten
7. Menopausal status and clinical outcomes in women with heart failure (GALACTIC-HF Trial)

The congress takes place in London, UK from August 30 to September 2, 2024.