UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
FORM
CURRENT REPORT
Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934
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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. ☐
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
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.
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CYTOKINETICS, INCORPORATED |
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Date: |
May 8, 2024 |
By: |
/s/ John O. Faurescu |
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John O. Faurescu, Esq., Associate General Counsel & Secretary |
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)
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
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
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
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 |
Condensed Consolidated Balance Sheets |
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(in thousands) |
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March 31, 2024 |
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December 31, 2023 |
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(unaudited) |
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ASSETS |
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Current assets: |
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Cash and short term investments |
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$ 618,961 |
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$ 614,824 |
Other current assets |
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19,743 |
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13,227 |
Total current assets |
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638,704 |
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628,051 |
Long-term investments |
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15,376 |
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40,534 |
Property and equipment, net |
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68,018 |
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68,748 |
Operating lease right-of-use assets |
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78,170 |
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78,987 |
Other assets |
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7,814 |
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7,996 |
Total assets |
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$ 808,082 |
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$ 824,316 |
LIABILITIES AND STOCKHOLDERS’ DEFICIT |
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Current liabilities: |
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Accounts payable and accrued liabilities |
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$ 53,090 |
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$ 64,148 |
Short-term operating lease liabilities |
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18,230 |
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17,891 |
Current portion of long-term debt |
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11,520 |
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10,080 |
Other current liabilities |
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6,015 |
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10,559 |
Total current liabilities |
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88,855 |
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102,678 |
Term loan, net |
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56,822 |
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58,384 |
Convertible notes, net |
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549,790 |
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548,989 |
Liabilities related to revenue participation right purchase agreements, net |
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390,219 |
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379,975 |
Long-term operating lease liabilities |
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118,554 |
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120,427 |
Other non-current liabilities |
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2 |
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186 |
Total liabilities |
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1,204,242 |
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1,210,639 |
Commitments and contingencies |
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Stockholders’ deficit: |
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Common stock |
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105 |
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102 |
Additional paid-in capital |
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1,852,155 |
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1,725,823 |
Accumulated other comprehensive loss |
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(539) |
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(10) |
Accumulated deficit |
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(2,247,881) |
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(2,112,238) |
Total stockholders’ deficit |
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(396,160) |
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(386,323) |
Total liabilities and stockholders’ deficit |
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$ 808,082 |
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$ 824,316 |
Cytokinetics, Incorporated |
Condensed Consolidated Statements of Operations |
(in thousands except per share data) |
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(unaudited) |
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Three Months Ended |
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March 31, 2024 |
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March 31, 2023 |
Revenues: |
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Research and development revenues |
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$ 835 |
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$ 2,113 |
Milestone revenues |
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— |
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2,500 |
Total revenues |
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835 |
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4,613 |
Operating expenses: |
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Research and development |
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81,570 |
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79,421 |
General and administrative |
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45,500 |
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49,665 |
Total operating expenses |
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127,070 |
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129,086 |
Operating loss |
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(126,235) |
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(124,473) |
Interest expense |
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(7,103) |
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(6,961) |
Non-cash interest expense on liabilities related to revenue participation right purchase agreements |
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(10,218) |
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(6,280) |
Interest and other income, net |
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7,913 |
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6,425 |
Net loss |
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$ (135,643) |
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$ (131,289) |
Net loss per share — basic and diluted |
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$ (1.33) |
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$ (1.38) |
Weighted-average number of shares used in computing net loss per share — basic and diluted |
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101,924 |
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95,164 |