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): May 08, 2024

 

 

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 May 8, 2024, Cytokinetics, Incorporated announced its financial results for the first quarter ended March 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 May 8, 2024

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:	May 8, 2024	By:	/s/ John O. Faurescu
			John O. Faurescu, Esq., Associate General Counsel & Secretary

 

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CYTOKINETICS REPORTS FIRST QUARTER 2024 FINANCIAL RESULTS

 

Primary Results and Two Additional Analyses from SEQUOIA-HCM to be Presented in a Late-Breaking Clinical Trial Session at the European Society of Cardiology Heart Failure 2024 Congress

 

Initiated Enrollment in CEDAR-HCM, a Clinical Trial of Aficamten

in a Pediatric Population with Obstructive HCM

 

Announced Topline Data from the Phase 1 Study of CK-586;

Phase 2 Clinical Trial to Begin in Q4 2024

 

SOUTH SAN FRANCISCO, Calif., May 8, 2024 - Cytokinetics, Incorporated (Nasdaq: CYTK) reported financial results for the first quarter of 2024. Net loss for the first quarter was $135.6 million, or $1.33 per share, compared to net loss for the first quarter of 2023 of $131.3 million, or $1.38 per share. Cash, cash equivalents and investments totaled $634.3 million at March 31, 2024.

 

“In the first quarter, we advanced our muscle-biology portfolio anchored by the broad development program of aficamten. In parallel with our preparation of regulatory submissions in multiple geographies alongside executing on our go-to-market strategies, we also furthered ongoing clinical trials, FOREST-HCM, MAPLE-HCM and ACACIA-HCM, and started a fourth clinical trial of aficamten, CEDAR-HCM, a clinical trial in pediatric patients with obstructive HCM, another underserved cohort of patients with HCM,” said Robert I. Blum, Cytokinetics’ President and Chief Executive Officer. “At the same time, we progressed CK-586 towards a Phase 2 clinical trial expected to begin later this year. We believe that our cohesive biology anchored in cardiac myosin positions the company well to fulfill our mission to deliver important medicines and increase shareholder value as will be further enabled by solid financials, access to diversified capital and executing on capital efficient Business and Corporate Development plans.”

 

Q1 and Recent Highlights

 

Cardiac Muscle Programs

 

aficamten (cardiac myosin inhibitor)

 

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omecamtiv mecarbil (cardiac myosin activator)

 

 

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

 

 

CK-3828136 (CK-136, cardiac troponin activator)

 

 

Pre-Clinical Development and Ongoing Research

 

 

Corporate

 

 

 

 

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Financials

 

Revenues for the first quarter 2024 were $0.8 million compared to $4.6 million for the corresponding period in 2023. The decrease in revenues was primarily due to milestone revenue of $2.5 million received from Ji Xing Pharmaceuticals for the start of ACACIA-HCM and higher collaboration revenues in 2023.

 

Research and development expenses for the first quarter 2024 increased to $81.6 million compared to $79.4 million for the same period in 2023, due to spending for our clinical development activities for our cardiac myosin inhibitor programs.

 

General and administrative expenses for the first quarter 2024 decreased to $45.5 million from $49.7 million for the same period in 2023 due to lower outside spending for pre-commercial launch activities.

 

Conference Call and Webcast Information

 

Members of Cytokinetics’ senior management team will review the company’s first 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 Q1 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 late-stage, specialty cardiovascular biopharmaceutical company focused on discovering, developing and commercializing first-in-class muscle activators and next-in-class muscle inhibitors as potential treatments for debilitating diseases in which cardiac muscle performance is compromised. As a leader in muscle biology and the mechanics of muscle performance, the company is developing small molecule drug candidates specifically engineered to impact myocardial muscle function and contractility. Cytokinetics is preparing for regulatory submissions for aficamten, its next-in-class cardiac myosin inhibitor, following positive results from SEQUOIA-HCM, the pivotal Phase 3 clinical trial in obstructive hypertrophic cardiomyopathy. Aficamten is also currently being evaluated in MAPLE-HCM, a Phase 3 clinical trial of aficamten as monotherapy compared to metoprolol as monotherapy in patients with obstructive HCM, ACACIA-HCM, a Phase 3 clinical trial of aficamten in patients with non-obstructive HCM, CEDAR-HCM, a clinical trial of aficamten in a pediatric population with obstructive HCM, and FOREST-HCM, an open-label extension clinical study of aficamten in patients with HCM. . Cytokinetics is also developing omecamtiv mecarbil, a cardiac muscle activator, in patients with heart failure. Additionally, Cytokinetics is developing CK-586, a cardiac myosin inhibitor with a mechanism of action distinct from aficamten for the potential treatment of HFpEF, and CK-136, a cardiac troponin activator

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for the potential treatment HFrEF and other types of heart failure, such as right ventricular failure resulting from impaired cardiac contractility.

 

For additional information about Cytokinetics, visit www.cytokinetics.com and follow us on X, LinkedIn, Facebook and YouTube.

 

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 ability to file a new drug application for aficamten in the United States in the third quarter of 2024 or a marketing authorisation application for aficamten in the European Union in the fourth quarter of 2024, our ability to complete enrollment of MAPLE-HCM in the third quarter of 2024 and to commence a Phase 2 study of CK-586, if ever, 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, aficamten, CK-586, CK-136 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 Ji Xing; statements relating to our operating expenses or cash utilization for the remainder of 2024, and statements relating to our cash balance at year-end 2024 or any other 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 2023. 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

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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.

 

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Contact:

Cytokinetics

Diane Weiser

Senior Vice President, Corporate Affairs

(415) 290-7757

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Cytokinetics, Incorporated

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Condensed Consolidated Balance Sheets
(in thousands)
		March 31, 2024		December 31, 2023
		(unaudited)
ASSETS
Current assets:
Cash and short term investments		$ 618,961		$ 614,824
Other current assets		19,743		13,227
Total current assets		638,704		628,051
Long-term investments		15,376		40,534
Property and equipment, net		68,018		68,748
Operating lease right-of-use assets		78,170		78,987
Other assets		7,814		7,996
Total assets		$ 808,082		$ 824,316
LIABILITIES AND STOCKHOLDERS’ DEFICIT
Current liabilities:
Accounts payable and accrued liabilities		$ 53,090		$ 64,148
Short-term operating lease liabilities		18,230		17,891
Current portion of long-term debt		11,520		10,080
Other current liabilities		6,015		10,559
Total current liabilities		88,855		102,678
Term loan, net		56,822		58,384
Convertible notes, net		549,790		548,989
Liabilities related to revenue participation right purchase agreements, net		390,219		379,975
Long-term operating lease liabilities		118,554		120,427
Other non-current liabilities		2		186
Total liabilities		1,204,242		1,210,639
Commitments and contingencies
Stockholders’ deficit:
Common stock		105		102
Additional paid-in capital		1,852,155		1,725,823
Accumulated other comprehensive loss		(539)		(10)
Accumulated deficit		(2,247,881)		(2,112,238)
Total stockholders’ deficit		(396,160)		(386,323)
Total liabilities and stockholders’ deficit		$ 808,082		$ 824,316

 

 

 

 

 

 

 

 

 

Cytokinetics, Incorporated

Condensed Consolidated Statements of Operations

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(in thousands except per share data)
(unaudited)
		Three Months Ended
		March 31, 2024		March 31, 2023
Revenues:
Research and development revenues		$ 835		$ 2,113
Milestone revenues		—		2,500
Total revenues		835		4,613
Operating expenses:
Research and development		81,570		79,421
General and administrative		45,500		49,665
Total operating expenses		127,070		129,086
Operating loss		(126,235)		(124,473)
Interest expense		(7,103)		(6,961)
Non-cash interest expense on liabilities related to revenue participation right purchase agreements		(10,218)		(6,280)
Interest and other income, net		7,913		6,425
Net loss		$ (135,643)		$ (131,289)
Net loss per share — basic and diluted		$ (1.33)		$ (1.38)
Weighted-average number of shares used in computing net loss per share — basic and diluted		101,924		95,164

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v3.24.1.u1

Document And Entity Information	May 08, 2024
Cover [Abstract]
Document Type	8-K
Amendment Flag	false
Document Period End Date	May 08, 2024
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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