CYTK Cytokinetics Inc

 

UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549

 

FORM 8-K

 

CURRENT REPORT

Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934

Date of Report (Date of earliest event reported): February 27, 2025

 

 

Cytokinetics, Incorporated

(Exact name of Registrant as Specified in Its Charter)

 

 

Delaware			000-50633	94-3291317
(State or Other Jurisdiction of Incorporation)			(Commission File Number)	(IRS Employer Identification No.)
350 Oyster Point Boulevard
South San Francisco, California				94080
(Address of Principal Executive Offices)				(Zip Code)

 

Registrant’s Telephone Number, Including Area Code: (650) 624-3000

 

n/a

(Former Name or Former Address, if Changed Since Last Report)

 

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:

Securities registered pursuant to Section 12(b) of the Act:

Title of each class		Trading Symbol(s)		Name of each exchange on which registered
Common Stock, $0.001 par value		CYTK		The Nasdaq Global Select Market

Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§ 230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§ 240.12b-2 of this chapter).

Emerging growth company ☐

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐

 

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Item 2.02 Results of Operations and Financial Condition.

On February 27, 2025, Cytokinetics, Incorporated announced its financial results for the fourth quarter and for the year ended December 31, 2024. The full text of the press release issued in connection with this announcement is furnished as Exhibit 99.1 to this Current Report on Form 8-K. The information furnished under this Item 2.02 and under Exhibit 99.1 shall not be considered “filed” under the Securities Exchange Act of 1934, as amended, nor shall it be incorporated by reference into any future filing under the Securities Act of 1933, as amended, or under the Securities Exchange Act of 1934, as amended, unless the Registrant expressly sets forth in such future filing that such information is to be considered “filed” or incorporated by reference therein.

Item 9.01 Financial Statements and Exhibits.

(d) Exhibits

 

99.1 Press Release dated February 27, 2025

104 The cover page of this report has been formatted in Inline XBRL

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SIGNATURES

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.

			CYTOKINETICS, INCORPORATED
Date:	February 27, 2025	By:	/s/ John Faurescu
			John Faurescu VP, Associate General Counsel & Secretary

 

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CYTOKINETICS REPORTS FOURTH QUARTER 2024 FINANCIAL RESULTS

AND PROVIDES BUSINESS UPDATE

 

Commercial Launch Preparations Advancing Prior to September 26 PDUFA Date;

Regulatory Filings Under Review in U.S., Europe and China

 

Topline Results from MAPLE-HCM Expected in Q2 2025

 

Company Provides 2025 Financial Guidance;

~$1.2 Billion in Cash, Cash Equivalents and Investments as of December 31, 2024

 

SOUTH SAN FRANCISCO, Calif., Feb. 27, 2025 - Cytokinetics, Incorporated (Nasdaq: CYTK) reported a management update and financial results for the fourth quarter and full year of 2024. The company also provided full year 2025 financial guidance.

 

“The fourth quarter of 2024 capped off a momentous year for Cytokinetics with progress and achievements across our business. With regulatory submissions on file in the U.S., Europe and China for aficamten and regulatory review activities underway, we are approaching a key inflection point, and our commercial readiness activities are on track to support planned launch activities,” said Robert I. Blum, Cytokinetics’ President and Chief Executive Officer. “During recent months, we also started important clinical trials advancing later-stage development programs, setting us up to potentially deliver multiple new medicines to patients over the next several years. With a strong balance sheet and additional access to investment capital, we are well-funded to execute the potential commercial launch of aficamten in 2025, while we advance our pipeline and continue investing in research for the benefit of all stakeholders.”

 

Q4 and Recent Highlights

 

Cardiac Muscle Programs

 

aficamten (cardiac myosin inhibitor)

 

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omecamtiv mecarbil (cardiac myosin activator)

 

 

 

 

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CK-4021586 (CK-586, cardiac myosin inhibitor)

 

 

CK-4015089 (CK-089, fast skeletal muscle troponin activator)

 

 

Pre-Clinical Development and Ongoing Research

 

 

Corporate

 

 

 

2025 Corporate Milestones

 

Cardiac Muscle Programs

 

aficamten (cardiac myosin inhibitor)

 

 

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omecamtiv mecarbil (cardiac myosin activator)

 

 

CK-586 (cardiac myosin inhibitor)

 

 

Skeletal Muscle Program

 

CK-089 (fast skeletal muscle troponin activator)

 

 

Ongoing Research

 

 

Fourth Quarter and Full Year 2024 Financial Results

 

Cash, Cash Equivalents and Investments

 

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Revenues

 

 

Research and Development (R&D) Expenses

 

 

General and Administrative (G&A) Expenses

 

 

Net Income (Loss)

 

 

2025 Financial Guidance

 

The company today announced financial guidance for 2025:

 

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GAAP operating expense*	$670 million to $710 million
Non-cash stock-based compensation expense included in GAAP operating expense	$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 of aficamten for patients with oHCM.

 

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 fourth quarter 2024 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. The live audio of the conference call can also be accessed by telephone by registering in advance at the following link: Cytokinetics Q4 2024 Earnings Conference Call. Upon registration, participants will receive a dial-in number and a unique passcode to access the call. An archived replay of the webcast will be available via Cytokinetics’ website for twelve months.

 

About Cytokinetics

 

Cytokinetics is a leading muscle biology specialty biopharmaceutical company focused on discovering, developing and commercializing muscle biology-directed drug candidates as potential treatments for debilitating diseases in which muscle performance is compromised. As a pioneer in muscle and the mechanics of muscle performance, Cytokinetics is intent on meaningfully improving the lives of patients through global access to innovative medicines. Cytokinetics is readying for potential regulatory approvals and commercialization of aficamten, a potential next-in-class cardiac myosin inhibitor following positive results from SEQUOIA-HCM, the pivotal Phase 3 clinical trial in patients with obstructive hypertrophic cardiomyopathy (HCM). Aficamten is also being evaluated in additional clinical trials enrolling patients with obstructive and non-obstructive HCM. Cytokinetics is also developing omecamtiv mecarbil, a cardiac myosin activator, in patients with heart failure with severely reduced ejection fraction (HFrEF), CK-586, a cardiac myosin inhibitor with a mechanism of action distinct from aficamten, 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, visit www.cytokinetics.com and follow us on X, LinkedIn, Facebook and YouTube.

 

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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 of aficamten in the United States or any other jurisdiction by the target PDUFA date or any other date, if ever, our ability to complete enrollment of ACACIA-HCM, CEDAR-HCM and AMBER-HFpEF in the second half of 2025, our ability to complete patient enrollment of COMET-HF in 2026, 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, CK-586, 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’ Annual Report on Form 10-K for the year ended December 31, 2024. 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.

 

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CYTOKINETICS® and the CYTOKINETICS and C-shaped logo are registered trademarks of Cytokinetics in the U.S. and certain other countries.

 

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Contact:

Cytokinetics

Diane Weiser

Senior Vice President, Corporate Affairs

(415) 290-7757

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Cytokinetics, Incorporated
Condensed Consolidated Balance Sheets
(in thousands)
		December 31, 2024		December 31, 2023
		(unaudited)
ASSETS
Current assets:
Cash and short-term investments		$ 1,076,014		$ 614,824
Other current assets		31,926		13,227
Total current assets		1,107,940		628,051
Long-term investments		145,055		40,534
Property and equipment, net		65,815		68,748
Operating lease right-of-use assets		75,158		78,987
Other assets		7,705		7,996
Total assets		$ 1,401,673		$ 824,316
LIABILITIES AND STOCKHOLDERS’ DEFICIT
Current liabilities:
Accounts payable and accrued liabilities		$ 75,692		$ 64,148
Short-term operating lease liabilities		18,978		17,891
Current portion of long-term debt		11,520		10,080
Derivative liabilities measured at fair value		11,300		—
Deferred revenue		52,370		—
Other current liabilities		9,814		10,559
Total current liabilities		179,674		102,678
Term loan, net		93,227		58,384
Convertible notes, net		552,370		548,989
Liabilities related to revenue participation right purchase agreements, net		462,192		379,975
Long-term operating lease liabilities		112,582		120,427
Liabilities related to RPI Transactions measured at fair value		137,000		—
Other non-current liabilities		—		186
Total liabilities		1,537,045		1,210,639
Commitments and contingencies
Stockholders' deficit
Common stock		118		102
Additional paid-in capital		2,563,876		1,725,823
Accumulated other comprehensive income (loss)		2,398		(10)
Accumulated deficit		(2,701,764)		(2,112,238)
Total stockholders' deficit		(135,372)		(386,323)
Total liabilities and stockholders' deficit		$ 1,401,673		$ 824,316

 

 

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Cytokinetics, Incorporated
Condensed Consolidated Statements of Operations
(in thousands except per share data)
(unaudited)
		Three Months Ended December 31,				Years Ended December 31,
		2024		2023		2024		2023
Revenues:
License and milestone revenues		$ 15,000		$ 1,000		$ 15,000		$ 3,500
Collaboration revenues		1,927		672		3,474		4,030
Realization of revenue participation right purchase agreement		—		—		—		—
Total revenues		16,927		1,672		18,474		7,530
Operating expenses:
Research and development		93,629		84,976		339,408		330,123
General and administrative		62,338		44,114		215,314		173,612
Total operating expenses		155,967		129,090		554,722		503,735
Operating loss		(139,040)		(127,418)		(536,248)		(496,205)
Interest expense		(8,938)		(7,164)		(37,701)		(28,306)
Non-cash interest expense on liabilities related to revenue participation right purchase agreements		(13,656)		(9,900)		(48,811)		(29,362)
Interest and other income, net		15,014		7,586		51,534		27,629
Change in fair value of derivative liabilities		1,200		—		1,300		—
Change in fair value of liabilities related to RPI Transactions		(4,600)		—		(19,600)		—
Net loss before income taxes		(150,020)		(136,896)		(589,526)		(526,244)
Income tax benefit		—		—		—		—
Net loss		$ (150,020)		$ (136,896)		$ (589,526)		$ (526,244)
Net loss per share — basic and diluted		$ (1.26)		$ (1.38)		$ (5.26)		$ (5.45)

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Weighted-average shares in net loss per share — basic and diluted		118,075		99,067		111,979		96,524

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v3.25.0.1

Document And Entity Information	Feb. 27, 2025
Cover [Abstract]
Document Type	8-K
Amendment Flag	false
Document Period End Date	Feb. 27, 2025
Entity Registrant Name	Cytokinetics, Incorporated
Entity Central Index Key	0001061983
Entity Emerging Growth Company	false
Entity File Number	000-50633
Entity Incorporation, State or Country Code	DE
Entity Tax Identification Number	94-3291317
Entity Address, Address Line One	350 Oyster Point Boulevard
Entity Address, City or Town	South San Francisco
Entity Address, State or Province	CA
Entity Address, Postal Zip Code	94080
City Area Code	(650)
Local Phone Number	624-3000
Entity Information, Former Legal or Registered Name	n/a
Written Communications	false
Soliciting Material	false
Pre-commencement Tender Offer	false
Pre-commencement Issuer Tender Offer	false
Title of 12(b) Security	Common Stock, $0.001 par value
Trading Symbol	CYTK
Security Exchange Name	NASDAQ

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