Full Press Release Details
Interactions with FDA Progressing Towards December 26, 2025 PDUFA Date for Aficamten; U.S. Commercial Launch Preparations on Track
Ex-U.S. Regulatory Reviews of Aficamten Ongoing in China and E.U.
~$1.25 Billion in Cash, Cash Equivalents and Investments as of September 30, 2025
SOUTH SAN FRANCISCO, Calif., Nov. 05, 2025 (GLOBE NEWSWIRE) -- Cytokinetics, Incorporated (Nasdaq: CYTK) reported a management update and financial results for the third quarter of 2025.
“I’m pleased that our teams continue to demonstrate strong execution and sustained momentum as we approach the PDUFA date for theaficamtenNDA. Our commercial preparations have been deliberate and strategic, positioning us well for this milestone,” said Robert I. Blum, Cytokinetics’ President and Chief Executive Officer. “During the third quarter, we expanded the evidence base foraficamten,with MAPLE-HCM further reinforcing the potential ofaficamtenin patients with obstructive HCM. With a strong balance sheet, clear focus, and a deep commitment to our mission, we are entering this pivotal transformation toward potential commercialization with confidence, alignment and purpose as we aim to deliver on the promise of translating our science to a new medicine for patients.”
Q3 and Recent Highlights
Cardiac Muscle Programs
aficamten(cardiac myosin inhibitor)
omecamtiv mecarbil(cardiac myosin activator)
ulacamten(CK-4021586, cardiac myosin inhibitor)
Pre-Clinical Development and Ongoing Research
Corporate
Third Quarter 2025 Financial Results
Cash Equivalents and Investments
Revenues
Research and Development (R&D) Expenses
General and Administrative (G&A) Expenses
Net Income (Loss)
2025 Financial Guidance
The company is updating its full year 2025 financial guidance:
| Current Guidanceissued on 11/5/2025 | Prior Guidance | |
| GAAP operating expense* | $680 million to $700 million | $670 million to $710 million |
| Non-cash stock-based compensation expense included in GAAP operating expense | $120 million to $110 million | $120 million to $110 million |
*GAAP operating expense comprised of R&D and SG&A expenses.
Anticipated year-over-year increase in GAAP operating expense includes investments toward commercial readiness for the potential approval and launch ofaficamtenfor patients with obstructive HCM.
The financial guidance does not include the effect of GAAP adjustments as may be caused by events that occur subsequent to publication of this guidance, including but not limited to Business Development activities.
Conference Call and Webcast Information
Members of Cytokinetics’ senior management team will review the company’s third quarter 2025 results on a conference call today at 4:30 PM Eastern Time. The conference call will be simultaneously webcast and can be accessed from the Investors & Media section of Cytokinetics’ website atwww.cytokinetics.comor directly at the following link:Cytokinetics Q3 2025 Earnings Conference Call. An archived replay of the webcast will be available via Cytokinetics’ website for six months.
About Cytokinetics
Cytokinetics is a specialty cardiovascular biopharmaceutical company, building on its over 25 years of pioneering scientific innovations in muscle biology to advance a pipeline of potential new medicines for patients suffering from diseases of cardiac muscle dysfunction. Cytokinetics is readying for potential regulatory approvals and commercialization ofaficamten,a cardiac myosin inhibitor following positive results from SEQUOIA-HCM, the pivotal Phase 3 clinical trial in patients with obstructive hypertrophic cardiomyopathy (HCM).Aficamtenis also being evaluated in additional clinical trials enrolling patients with obstructive and non-obstructive HCM. Cytokinetics is also developingomecamtiv mecarbil, a cardiac myosin activator, in patients with heart failure with severely reduced ejection fraction (HFrEF),ulacamten, a cardiac myosin inhibitor with a mechanism of action distinct fromaficamten,for the potential treatment of heart failure with preserved ejection fraction (HFpEF) and CK-089, a fast skeletal muscle troponin activator with potential therapeutic application to a specific type of muscular dystrophy and other conditions of impaired skeletal muscle function.
For additional information about Cytokinetics, visitwww.cytokinetics.comand follow us onX,LinkedIn,FacebookandYouTube.
DisclaimerAficamten, omecamtiv mecarbil, ulacamtenand CK-089 are investigational medicines. They have not been approved nor determined to be safe or efficacious for any disease state or any indication by FDA or any other regulatory agency.
Forward-Looking Statements
This press release contains forward-looking statements for purposes of the Private Securities Litigation Reform Act of 1995 (the “Act”). Cytokinetics claims the protection of the Act’s Safe Harbor for forward-looking statements. Examples of such statements include, but not limited to, statements, express or implied, relating to our or our partners’ research and development and commercial readiness activities, including the initiation, conduct, design, enrollment, progress, continuation, completion, timing and results of any of our clinical trials, or more specifically, our receipt of regulatory approval by FDA or any other regulatory authority to enable our commercialization ofaficamtenin the United States by the target PDUFA date or in any other jurisdiction by any target date, if ever, our ability to complete enrollment of CEDAR-HCM and AMBER-HFpEF by any target date, our ability to complete patient enrollment of COMET-HF by any target date, our ability to announce the results of ACACIA-HCM in of the second quarter of 2026, our ability to announce the results of any of our clinical trials by any particular date, the timing of interactions with FDA or any other regulatory authorities in connection to any of our drug candidates and the outcomes of such interactions; statements relating to the potential patient population who could benefit fromaficamten,omecamtiv mecarbil,ulacamten, CK-089 or any of our other drug candidates; statements relating to our ability to receive additional capital or other funding, including, but not limited to, our ability to meet any of the conditions relating to or to otherwise secure additional loan disbursements under any of our agreements with entities affiliated with Royalty Pharma or additional milestone payments from Sanofi or Bayer in connection with our collaborations foraficamtenin China or Japan respectively; statements relating to our operating expenses or cash utilization for the remainder of 2025 or any other period, and statements relating to our cash balance at any particular date or the amount of cash runway such cash balances represent at any particular time. Such statements are based on management's current expectations, but actual results may differ materially due to various risks and uncertainties, including, but not limited to Cytokinetics’ need for additional funding and such additional funding may not be available on acceptable terms, if at all; potential difficulties or delays in the development, testing, regulatory approvals for trial commencement, progression or product sale or manufacturing, or production of Cytokinetics’ drug candidates that could slow or prevent clinical development or product approval; patient enrollment for or conduct of clinical trials may be difficult or delayed; the FDA or foreign regulatory agencies may delay or limit Cytokinetics’ or its partners’ ability to conduct clinical trials; Cytokinetics may incur unanticipated research and development and other costs; standards of care may change, rendering Cytokinetics’ drug candidates obsolete; and competitive products or alternative therapies may be developed by others for the treatment of indications Cytokinetics’ drug candidates and potential drug candidates may target. For further information regarding these and other risks related to Cytokinetics’ business, investors should consult Cytokinetics’ filings with the Securities and Exchange Commission, particularly under the caption “Risk Factors” in Cytokinetics’ Quarterly Report on Form 10-Q for the quarter ended September 30, 2025. Forward-looking statements are not guarantees of future performance, and Cytokinetics’ actual results of operations, financial condition and liquidity, and the development of the industry in which it operates, may differ materially from the forward-looking statements contained in this press release. Any forward-looking statements that Cytokinetics makes in this press release speak only as of the date of this press release. Cytokinetics assumes no obligation to update its forward-looking statements whether as a result of new information, future events or otherwise, after the date of this press release.
CYTOKINETICS® and the CYTOKINETICS and C-shaped logo are registered trademarks of Cytokinetics in the U.S. and certain other countries.
Contact:CytokineticsDiane WeiserSenior Vice President, Corporate Affairs(415) 290-7757
| Cytokinetics, Incorporated | ||||||||
| Condensed Consolidated Balance Sheets | ||||||||
| (in thousands) | ||||||||
| September 30, 2025 | December 31, 2024 | |||||||
| (unaudited) | ||||||||
| ASSETS | ||||||||
| Current assets: | ||||||||
| Cash and short term investments | $ | 962,535 | $ | 1,076,014 | ||||
| Other current assets | 14,814 | 31,926 | ||||||
| Total current assets | 977,349 | 1,107,940 | ||||||
| Long-term investments | 288,817 | 145,055 | ||||||
| Property and equipment, net | 76,001 | 65,815 | ||||||
| Operating lease right-of-use assets | 77,580 | 75,158 | ||||||
| Other assets | 16,810 | 7,705 | ||||||
| Total assets | $ | 1,436,557 | $ | 1,401,673 | ||||
| LIABILITIES AND STOCKHOLDERS’ DEFICIT | ||||||||
| Current liabilities: | ||||||||
| Accounts payable and accrued liabilities | $ | 83,717 | $ | 75,692 | ||||
| Short-term operating lease liabilities | 20,647 | 18,978 | ||||||
| Current portion of long-term debt | 17,280 | 11,520 | ||||||
| Derivative liabilities measured at fair value | 16,900 | 11,300 | ||||||
| Deferred revenue | 1,612 | 52,370 | ||||||
| Other current liabilities | 1,988 | 9,814 | ||||||
| Total current liabilities | 142,144 | 179,674 | ||||||
| Term loan, net | 158,747 | 93,227 | ||||||
| Convertible notes, net | 889,524 | 552,370 | ||||||
| Liabilities related to revenue participation right purchase agreements, net | 504,498 | 462,192 | ||||||
| Long-term operating lease liabilities | 110,655 | 112,582 | ||||||
| Liabilities related to RPI Transactions measured at fair value | 150,500 | 137,000 | ||||||
| Other non-current liabilities | 1,612 | — | ||||||
| Total liabilities | 1,957,680 | 1,537,045 | ||||||
| Commitments and contingencies | ||||||||
| Stockholders' deficit | ||||||||
| Common stock | 122 | 118 | ||||||
| Additional paid-in capital | 2,782,409 | 2,563,876 | ||||||
| Accumulated other comprehensive income | 34 | 2,398 | ||||||
| Accumulated deficit | (3,303,688 | ) | (2,701,764 | ) | ||||
| Total stockholders' deficit | (521,123 | ) | (135,372 | ) | ||||
| Total liabilities and stockholders' deficit | $ | 1,436,557 | $ | 1,401,673 | ||||
| Cytokinetics, Incorporated | ||||||||||||||||
| Condensed Consolidated Statements of Operations | ||||||||||||||||
| (in thousands except per share data) | ||||||||||||||||
| (unaudited) | ||||||||||||||||
| Three Months Ended | Nine Months Ended | |||||||||||||||
| September 30, 2025 | September 30, 2024 | September 30, 2025 | September 30, 2024 | |||||||||||||
| Revenues: | ||||||||||||||||
| Collaboration revenues | $ | 1,936 | $ | 463 | $ | 5,931 | $ | 1,547 | ||||||||
| License and milestone revenues | — | — | 64,353 | — | ||||||||||||
| Total revenues | 1,936 | 463 | 70,284 | 1,547 | ||||||||||||
| Operating expenses: | ||||||||||||||||
| Research and development | 99,233 | 84,612 | 311,628 | 245,779 | ||||||||||||
| General and administrative | 69,458 | 56,652 | 192,548 | 152,976 | ||||||||||||
| Total operating expenses | 168,691 | 141,264 | 504,176 | 398,755 | ||||||||||||
| Operating loss | (166,755 | ) | (140,801 | ) | (433,892 | ) | (397,208 | ) | ||||||||
| Interest expense | (11,353 | ) | (8,928 | ) | (31,305 | ) | (28,763 | ) | ||||||||
| Non-cash interest expense on liabilities related to revenue participation right purchase agreements | (14,969 | ) | (13,370 | ) | (42,228 | ) | (35,155 | ) | ||||||||
| Interest and other income, net | 10,248 | 17,054 | 36,950 | 36,520 | ||||||||||||
| Change in fair value of derivative liabilities | 700 | 700 | 3,300 | 100 | ||||||||||||
| Change in fair value of liabilities related to RPI Transactions | (2,800 | ) | (15,200 | ) | (13,500 | ) | (15,000 | ) | ||||||||
| Debt conversion expense | (121,249 | ) | — | (121,249 | ) | — | ||||||||||
| Net loss | $ | (306,178 | ) | $ | (160,545 | ) | $ | (601,924 | ) | $ | (439,506 | ) | ||||
| Net loss per share — basic and diluted | $ | (2.55 | ) | $ | (1.36 | ) | $ | (5.04 | ) | $ | (4.00 | ) | ||||
| Weighted-average number of shares used in computing net loss per share — basic and diluted | 119,982 | 117,685 | 119,317 | 109,932 | ||||||||||||