Cytokinetics Inc. - CYTK STOCK NEWS

Cytokinetics presented additional analyses from the SEQUOIA-HCM Phase 3 trial of aficamten in patients with symptomatic obstructive hypertrophic cardiomyopathy (HCM) at the HFSA Annual Scientific Meeting. The results were also published in the Journal of the American College of Cardiology.

Key findings after 24 weeks of treatment include:

• 68% of aficamten-treated patients showed complete hemodynamic response vs. 7% for placebo
• 71% experienced symptom relief vs. 42% for placebo
• 46.5% showed enhanced exercise capacity vs. 24% for placebo
• 84% demonstrated substantial cardiac biomarker response vs. 8% for placebo

Overall, 97% of aficamten-treated patients achieved one or more clinically relevant outcomes, with 62% achieving at least three outcomes and 23% achieving all four outcomes. The number needed to treat was fewer than 5 patients for each outcome.

Cytokinetics (Nasdaq: CYTK) presented additional data from SEQUOIA-HCM, the Phase 3 trial of aficamten in patients with symptomatic obstructive hypertrophic cardiomyopathy (HCM), at the HCMS Scientific Sessions. The new analysis showed that aficamten treatment was associated with beneficial changes in five indices reflecting structural, electrophysiologic, and biomarker changes compared to placebo at 24 weeks:

• Improvement in maximal wall thickness (47.9% vs 30.7%; p=0.003)
• Improvement in left atrial volume index category (46.8% vs. 18.7%; p<0.001)
• Resolution of ECG changes consistent with left ventricular hypertrophy (19.0% vs. 4.3%; p<0.001)
• Normalization of hyperdynamic left ventricular ejection fraction (35.2% vs 20.7%; p<0.007)
• Reduction in NT-proBNP by ≥50% from baseline (81.7% vs. 7.1%; p<0.001)

Overall, 83.8% of patients treated with aficamten experienced favorable effects in at least one of the five domains, compared to 39.3% of patients on placebo (p<0.001, NNT = 2.2).

Cytokinetics (Nasdaq: CYTK) has announced its seventh annual Communications Grant Program, offering $100,000 in grants to patient advocacy organizations focused on cardiovascular diseases. The program will award five grants of $20,000 each to organizations serving the hypertrophic cardiomyopathy (HCM) and heart failure communities.

The grants aim to support increased communications, awareness building, and community engagement. Eligible organizations must be nonprofits or registered charities in the United States, Canada, Europe, or United Kingdom. The application deadline is November 4th, 2024, with recipients to be announced in January 2025.

The program seeks to bridge the funding gap for communication efforts in nonprofit patient organizations, enabling them to reach broader audiences and connect patients with available resources. Applications can be submitted online, and recipients will be required to provide an outcomes report at the end of the year.

Cytokinetics (Nasdaq: CYTK) announced upcoming presentations at two major cardiology conferences in Atlanta, GA. At the Hypertrophic Cardiomyopathy Medical Society (HCMS) Scientific Sessions on September 27, 2024, three presentations will focus on:

• Global remodeling changes with aficamten in obstructive hypertrophic cardiomyopathy patients
• Efficacy and safety of aficamten in patients with very high left ventricular outflow tract gradients
• Beta-blocker use and new atrial fibrillation in post-septal myectomy patients

Additionally, at the Heart Failure Society of America (HFSA) Annual Scientific Meeting on September 30, 2024, a Late Breaking Clinical Trial presentation will discuss the global clinical impact of aficamten in obstructive hypertrophic cardiomyopathy, based on results from the SEQUOIA-HCM trial. These presentations highlight Cytokinetics' ongoing research in cardiac treatments, particularly focusing on aficamten's effects in hypertrophic cardiomyopathy patients.

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.