MYQORZO® Approved for Adults with Symptomatic Obstructive HCM in U.S., China and Europe;
U.S. Launch Underway with First Prescriptions Dispensed within Days of Drug Availability
Supplemental NDA for MAPLE-HCM Submitted to FDA in Q1 2026
Expect to Share Topline Results from ACACIA-HCM in Q2 2026
Company Provides 2026 Financial Guidance;
~$1.2 Billion in Cash, Cash Equivalents and Investments as of December 31, 2025
SOUTH SAN FRANCISCO, Calif., Feb. 24, 2026 (GLOBE NEWSWIRE) -- Cytokinetics, Incorporated (NASDAQ:CYTK) reported a management update and financial results for the fourth quarter and full year of 2025. The company also provided full year 2026 financial guidance.
"The fourth quarter of 2025 marked a defining moment for Cytokinetics with the FDA approval of MYQORZO and our transition into a commercial-stage company," said Robert I. Blum, Cytokinetics' President and Chief Executive Officer. "With the U.S. launch of MYQORZO now underway and our first European launch planned in Germany in Q2, we're entering 2026 with strong momentum. Early prescribing activity and initial customer feedback reinforce that our differentiated label and REMS are resonating with HCPs and patients. We took measures in 2025 to fortify our balance sheet to support our commercial plans and continue with potential label-expanding opportunities in HCM and ongoing clinical trials in heart failure. We are well-positioned to deliver for patients, advance our pipeline, and create long-term value."
Q4 and Recent Highlights
Cardiac Muscle Programs
MYQORZO™ (aficamten) (cardiac myosin inhibitor)
omecamtiv mecarbil (cardiac myosin activator)
ulacamten (cardiac myosin inhibitor)
Pre-Clinical Development and Ongoing Research
Corporate
Expected 2026 Corporate Milestones
Cardiac Muscle Programs
MYQORZO® (aficamten) (cardiac myosin inhibitor)
omecamtiv mecarbil (cardiac myosin activator)
ulacamten (cardiac myosin inhibitor)
Ongoing research
Fourth Quarter and Full Year 2025 Financial Results
Cash Equivalents and Investments
Revenues
Research and Development (R&D) Expenses
General and Administrative (G&A) Expenses
Net Income (Loss)
2026 Financial Guidance
The company today announced financial guidance for 2026:
| GAAP Combined R&D and SG&A Expense* | $830 million to $870 million |
| Non-cash stock-based compensation expense included in GAAP Combined R&D and SG&A Expense | $130 million to $120 million |
*GAAP Combined R&D and SG&A expense does not include 1) collaboration expenses which can include reimbursed expenses and cost of inventory sales of aficamten to partners, 2) potential costs related to commercialization of aficamten in nHCM, and 3) 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 fourth 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 at www.cytokinetics.com or directly at the following link: Cytokinetics Q4 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, and advancing a pipeline of potential new medicines for patients suffering from diseases of cardiac muscle dysfunction. Cytokinetics' MYQORZO™ (aficamten) is a cardiac myosin inhibitor approved in the U.S., Europe and China for the treatment of adults with symptomatic obstructive hypertrophic cardiomyopathy (oHCM). Aficamten is also being studied for the potential treatment of non-obstructive HCM. Cytokinetics is also developing omecamtiv mecarbil, an investigational cardiac myosin activator for the potential treatment of patients with heart failure with severely reduced ejection fraction and ulacamten, an investigational cardiac myosin inhibitor for the potential treatment of heart failure with preserved ejection fraction, while continuing pre-clinical research and development in muscle biology.
For additional information about Cytokinetics, visit www.cytokinetics.com and follow us on X, LinkedIn, Facebook and YouTube.
Disclaimer
Omecamtiv mecarbil and ulacamten 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 ability to launch MYQORZO in Germany in 2Q of 2026, our receipt of regulatory approval for our sNDA for MAPLE-HCM in Q4 of 2026, 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 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 from aficamten, 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 for aficamten in 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 C-shaped logo are registered trademarks of Cytokinetics in the U.S. and certain other countries.
MYQORZOTM is a trademark of Cytokinetics in the U.S., and a registered trademark in the European Union.
MYQORZO & You TM is a trademark of Cytokinetics in the U.S.
Contact:
Cytokinetics
Diane Weiser
Senior Vice President, Corporate Affairs
(415) 290-7757
| Cytokinetics, Incorporated | ||||||||
| Condensed Consolidated Balance Sheets | ||||||||
| (in thousands) | ||||||||
| December 31, 2025 | December 31, 2024 | |||||||
| (unaudited) | ||||||||
| ASSETS | ||||||||
| Current assets: | ||||||||
| Cash and short-term investments | $ | 882,221 | $ | 1,076,014 | ||||
| Other current assets | 34,754 | 31,926 | ||||||
| Total current assets | 916,975 | 1,107,940 | ||||||
| Long-term investments | 335,048 | 145,055 | ||||||
| Property and equipment, net | 79,194 | 65,815 | ||||||
| Operating lease right-of-use assets | 75,979 | 75,158 | ||||||
| Other assets | 17,341 | 7,705 | ||||||
| Total assets | $ | 1,424,537 | $ | 1,401,673 | ||||
| LIABILITIES AND STOCKHOLDERS' DEFICIT | ||||||||
| Current liabilities: | ||||||||
| Accounts payable and accrued liabilities | $ | 105,615 | $ | 75,692 | ||||
| Short-term operating lease liabilities | 19,111 | 18,978 | ||||||
| Current portion of convertible and long-term debt | 41,181 | 11,520 | ||||||
| Derivative liabilities measured at fair value | 31,100 | 11,300 | ||||||
| Deferred revenue | 1,612 | 52,370 | ||||||
| Other current liabilities | 3,833 | 9,814 | ||||||
| Total current liabilities | 202,452 | 179,674 | ||||||
| Term loan, net | 246,384 | 93,227 | ||||||
| Convertible notes, net | 869,597 | 552,370 | ||||||
| Liabilities related to revenue participation right purchase agreements, net | 520,559 | 462,192 | ||||||
| Long-term operating lease liabilities | 107,970 | 112,582 | ||||||
| Liabilities related to RPI Transactions measured at fair value | 137,200 | 137,000 | ||||||
| Total liabilities | 2,084,162 | 1,537,045 | ||||||
| Commitments and contingencies | ||||||||
| Stockholders' deficit | ||||||||
| Common stock | 123 | 118 | ||||||
| Additional paid-in capital | 2,826,341 | 2,563,876 | ||||||
| Accumulated other comprehensive income | 630 | 2,398 | ||||||
| Accumulated deficit | (3,486,719 | ) | (2,701,764 | ) | ||||
| Total stockholders' deficit | (659,625 | ) | (135,372 | ) | ||||
| Total liabilities and stockholders' deficit | $ | 1,424,537 | $ | 1,401,673 | ||||
| Cytokinetics, Incorporated | |||||||||||||||||
| Condensed Consolidated Statements of Operations | |||||||||||||||||
| (in thousands except per share data) | |||||||||||||||||
| (unaudited) | |||||||||||||||||
| Three Months Ended December 31, | Years Ended December 31, | ||||||||||||||||
| 2025 | 2024 | 2025 | 2024 | ||||||||||||||
| Revenues: | |||||||||||||||||
| Collaboration revenues | $ | 2,755 | $ | 1,927 | $ | 8,686 | $ | 3,474 | |||||||||
| License and milestone revenues | 15,000 | 15,000 | 79,353 | 15,000 | |||||||||||||
| Total revenues | 17,755 | 16,927 | 88,039 | 18,474 | |||||||||||||
| Operating expenses: | |||||||||||||||||
| Research and development | 104,398 | 93,629 | 416,026 | 339,408 | |||||||||||||
| General and administrative | 91,723 | 62,338 | 284,271 | 215,314 | |||||||||||||
| Total operating expenses | 196,121 | 155,967 | 700,297 | 554,722 | |||||||||||||
| Operating loss | (178,366 | ) | (139,040 | ) | (612,258 | ) | (536,248 | ) | |||||||||
| Interest expense | (14,274 | ) | (8,938 | ) | (45,579 | ) | (37,701 | ) | |||||||||
| Non-cash interest expense on liabilities related to revenue participation right purchase agreements | (16,061 | ) | (13,656 | ) | (58,289 | ) | (48,811 | ) | |||||||||
| Interest and other income, net | 11,470 | 15,014 | 48,420 | 51,534 | |||||||||||||
| Change in fair value of derivative liabilities | 900 | 1,200 | 4,200 | 1,300 | |||||||||||||
| Change in fair value of liabilities related to RPI Transactions | 13,300 | (4,600 | ) | (200 | ) | (19,600 | ) | ||||||||||
| Debt conversion expense | — | — | (121,249 | ) | — | ||||||||||||
| Net loss | $ | (183,031 | ) | $ | (150,020 | ) | $ | (784,955 | ) | $ | (589,526 | ) | |||||
| Net loss per share — basic and diluted | $ | (1.50 | ) | $ | (1.26 | ) | $ | (6.54 | ) | $ | (5.26 | ) | |||||
| Weighted-average shares in net loss per share — basic and diluted | 122,434 | 118,075 | 120,103 | 111,979 | |||||||||||||
