CORRESP Filing
CYTOKINETICS INC
Date: Aug. 8, 2025 · CIK: 0001061983 · Accession: 0001193125-25-176976
AI Filing Summary & Sentiment
Reasoning
File numbers found in text: 000-50633
Referenced dates: July 29, 2025
Letter
Re: Cytokinetics, Inc.
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
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
3,013
7,564
6,680
Other programs
3,025
2,887
6,398
5,889
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/ S UNG H. L EE
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CORRESP 1 filename1.htm CORRESP 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/ S UNG H. L EE 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