August 8, 2025

Via EDGAR

Division of Corporation Finance

Office of Life Sciences

U.S. Securities and Exchange Commission

100 F Street, N.E.

Washington, DC 20549-6010

 

Attention:

Vanessa Robertson

Christine Torney

 

Re:	Cytokinetics, Inc.

Form 10-K for the fiscal year ended December 31, 2024

File No. 000-50633

Dear Ms. Robertson and Ms. Torney:

Cytokinetics, Incorporated (“Cytokinetics,” the “Company,” “we,” “our,” or “us”) is providing this letter in response to the comment received from the staff (the “Staff”) of the Securities and Exchange Commission by letter dated July 29, 2025 with respect to the above-referenced filing. For ease of reference, the Staff’s comment is reproduced below in bold and italicized type, followed by the Company’s response.

Form 10-K for the fiscal year ended December 31, 2024

Item 7. Management’s Discussion and Analysis of Financial Condition and Results of

Operations

Results of Operations

Research and Development Expenses, page 46

 

1.

Please provide revised disclosure to be included in future filings to break out research and development expenses by clinical program or trial. For amounts that are not tracked by program, provide other quantitative or qualitative disclosure that provides more transparency as to the type of research and development expenses incurred (i.e. by nature or type of expense) for each period presented which should reconcile to total research and development expense on the Statements of Operations.

Response: The Company respectfully acknowledges the Staff’s comment and will revise its future filings to include the following disclosure to explain research and development expenses, starting with the Company’s Quarterly Report on Form 10-Q for the quarter ending September 30, 2025. The following disclosure is based on the Company’s second quarter research and development expenses and therefore addresses research and development expenses for the three and six months ended June 30, 2025 and 2024.

Research and Development Expenses

We incur research and development expenses associated with both partnered and our own research activities, which we finance from our own cash-on-hand, financing arrangements with third parties, and reimbursement from our collaboration partners.

Research and development expenses for the three and six months ended June 30, 2025 and 2024, were as follows (in thousands):

 

		Three Months Ended												Six Months Ended
		June 30, 2025				June 30, 2024				Increase				June 30, 2025				June 30, 2024				Increase
External Costs:
Aficamten		$	29,390			$	20,958			$	8,432			$	58,938			$	44,155			$	14,783
Omecamtiv Mecarbil			3,967				954				3,013				7,564				6,680				884
Other programs			3,025				2,887				138				6,398				5,889				509
Unallocated			21,213				9,314				11,899				29,553				17,068				12,485
Total external costs			57,595				34,113				23,482				102,453				73,792				28,661
Internal Costs:
Employee related			41,109				32,634				8,475				81,136				63,934				17,202
Facilities, lab supplies and other			13,850				12,850				1,000				28,806				23,441				5,365
Total internal costs			54,959				45,484				9,475				109,942				87,375				22,567
Total research and development expense		$	112,554			$	79,597			$	32,957			$	212,395			$	161,167			$	51,228

Research and development expenses consist of external costs including contract research and manufacturing and consulting expenses. Aficamten external costs increased for the three and six months ended June 30, 2025, compared to the three and six months ended June 30, 2024, due primarily to the advancement of the ACACIA-HCM trial. Omecamtiv Mecarbil expenses increased in 2025 due to the COMET trial commencing in the fourth quarter of 2024. Unallocated external costs consist primarily of medical affairs, regulatory, quality and biostatistics.

We continue to develop aficamten to treat both oHCM and nHCM in three additional clinical trials, as follows: (i) MAPLE-HCM is our Phase 3 clinical trial of aficamten as a monotherapy for patients with oHCM, (ii) ACACIA-HCM is a Phase 3 clinical trial for patients with symptomatic nHCM, and (iii) CEDAR-HCM, our placebo-controlled and open-label extension clinical trial to evaluate the efficacy, pharmacokinetics (PK) and safety of aficamten in a pediatric population with symptomatic oHCM. Additionally, we have FOREST-HCM which is an open label extension study designed to assess the long term safety and tolerability of aficamten in patients with HCM.

We continue to develop omecamtiv mecarbil in COMET-HF, a Phase 3 clinical trial of omecamtiv mecarbil in patients with symptomatic HFrEF with severely reduced ejection fraction.

* * * * *

Please advise us if we can provide any further information or assistance to facilitate your review. Please direct any further comments or questions regarding this response letter to me at (949) 929-5744.

 

Sincerely,

/s/ SUNG H. LEE

Sung H. Lee

Executive Vice President, Chief Financial Officer

Cytokinetics, Incorporated

 

cc:	Robert I. Blum, President and Chief Executive Officer

John Faurescu, Vice President, Associate General Counsel and Corporate Secretary

Holly Laughlin, Vice President, Accounting and Corporate Controller

Daniel Coleman, Ernst & Young LLP

Chadwick Mills, Cooley LLP