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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): August 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:

☐Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
☐Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
☐Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
☐Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

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. ☐

 


Item 2.02 Results of Operations and Financial Condition.

On August 8, 2024, Cytokinetics, Incorporated announced its financial results for the second quarter ended June 30, 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)

 

99.1 Press Release dated August 8, 2024

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


SIGNATURES

 

 

 

CYTOKINETICS, INCORPORATED

 

 

 

 

Date:

August 8, 2024

By:

/s/ John O. Faurescu

 

 

 

John O. Faurescu, Esq., Vice President, Associate General Counsel & Secretary

 


EX-99.1 2 cytk-ex99_1.htm EX-99.1 EX-99.1

 

 

 

 

img114956760_0.jpg 

CYTOKINETICS REPORTS SECOND QUARTER 2024 FINANCIAL RESULTS

 

Type B Meeting Held with FDA Related to Potential Risk Mitigation Strategies for Aficamten;

Company Has Initiated Rolling NDA Submission

 

FDA Cleared Protocol Amendment for FOREST-HCM Reducing Frequency of

Echocardiographic Monitoring Required During Maintenance Treatment

 

~$1.4 Billion in Cash, Cash Equivalents and Investments as of June 30, 2024

 

SOUTH SAN FRANCISCO, Calif., Aug. 8, 2024 - Cytokinetics, Incorporated (Nasdaq: CYTK) reported a management update and financial results for the second quarter of 2024.

 

“Cytokinetics made substantial progress during the second quarter across our pipeline and aligned to near-term goals as well as our longer-term vision to build a sustainable specialty cardiology business. In May, we secured contingent access to more than $1 billion in funding to support the potential global launch of aficamten as well as to continue conduct of label-expanding clinical trials of aficamten worldwide and to advance our later-stage pipeline including omecamtiv mecarbil and CK-586,” said Robert I. Blum, Cytokinetics’ President and Chief Executive Officer. “These three programs, anchored in our pioneering science of myosin modulation provide synergistic opportunities in adjacent specialty cardiology indications that we believe will unlock shareholder value while making good on our promise to patients.”

 

Q2 and Recent Highlights

 

Cardiac Muscle Programs

 

aficamten (cardiac myosin inhibitor)

 

Presented primary results from SEQUOIA-HCM (Safety, Efficacy, and Quantitative Understanding of Obstruction Impact of Aficamten in HCM) at the European Society of Cardiology Heart Failure 2024 Congress, demonstrating statistically significant and clinically meaningful improvements in the primary efficacy endpoint of peak oxygen uptake (pVO2) and all secondary endpoints with results consistent across all prespecified subgroups. Additional results presented from SEQUOIA-HCM showed that treatment with aficamten resulted in predictable dosing with no dose interruptions or associated heart failure due to left ventricular ejection fraction (LVEF) <50% and improved a novel integrated exercise performance metric.

Improvements in pVO2 were shown to be highly correlated with improvements in cardiac structure and function.

 

 

Participated in a Type B meeting with the U.S. Food and Drug Administration (FDA) to discuss potential strategies related to safety monitoring and risk mitigation for aficamten and included a review of how results from SEQUOIA-HCM and intrinsic properties of aficamten may inform risk mitigation. The Company expects to propose a distinct risk mitigation approach specific to aficamten with the New Drug Application (NDA) for which the rolling submission is underway. The Company is on track to complete the rolling NDA submission for aficamten in Q3 2024.

 

The FDA recently cleared a protocol amendment for FOREST-HCM (Follow-up, Open-Label, Research Evaluation of Sustained Treatment with Aficamten in HCM) reducing the frequency of echocardiographic monitoring for patients with obstructive HCM to every 6 months during maintenance treatment for patients with LVEF >55%.

 

Participated in meetings with the European Medicines Agency (EMA) and National Agencies in the EU during which the company confirmed plans to submit a Marketing Authorization Application (MAA) for aficamten in Q4 2024 and discussed the content of the expected filing.

 

Coordinated with Ji Xing Pharmaceuticals to support the planned submission of an NDA for aficamten to the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) in China in 2H 2024.

 

Continued commercial readiness activities for aficamten including refining our market development campaign, designing the treatment experience inclusive of distribution and patient support programs, advancing key market research, and finalizing the structure for the field-based sales team. Began pre-approval information exchange activities to proactively share health care economic and scientific information with payers and initiated development of U.S. and global value dossiers.

 

Initiated a Phase 1 study evaluating the pharmacokinetics, safety and tolerability of aficamten in healthy Japanese and Caucasian participants. We expect to continue enrollment throughout 2024.

 

Opened enrollment to CEDAR-HCM (Clinical Evaluation of Dosing with Aficamten to Reduce Obstruction in a Pediatric Population in HCM), a clinical trial of aficamten in a pediatric population with symptomatic obstructive HCM. We expect to continue enrollment in CEDAR-HCM throughout 2024.

 

Continued enrolling patients in MAPLE-HCM (Metoprolol vs Aficamten in Patients with LVOT Obstruction on Exercise Capacity in HCM), the Phase 3 clinical trial comparing aficamten as monotherapy to metoprolol as monotherapy in patients with symptomatic obstructive HCM. We expect to complete enrollment in MAPLE-HCM in Q3 2024.

 

Continued enrolling patients in ACACIA-HCM (Assessment Comparing Aficamten to Placebo on Cardiac Endpoints In Adults with Non-Obstructive HCM), the pivotal Phase 3 clinical trial of aficamten in patients with non-obstructive HCM. We expect to continue enrollment in ACACIA-HCM throughout 2024 and complete enrollment in 2025.

 

Published the following manuscripts:

 

“Aficamten for Symptomatic Obstructive Hypertrophic Cardiomyopathy” in the New England Journal of Medicine.

 

“The Prognostic Value of Peak Oxygen Uptake in Obstructive Hypertrophic Cardiomyopathy: A Literature Review to Inform Economic Model Development” in the Journal of Medical Economics.

 

“Safety and Efficacy of Aficamten in Patients with Non-Obstructive Hypertrophic Cardiomyopathy: A 36-Week Analysis from FOREST-HCM” in the European Journal of Heart Failure.

 

“Aficamten is a Small-Molecule Cardiac Myosin Inhibitor Designed to Treat Hypertrophic Cardiomyopathy” in Nature Cardiovascular Research.

 

“Dosing and Safety Profile of Aficamten in Symptomatic Obstructive Hypertrophic Cardiomyopathy: Results From SEQUOIA-HCM” in Journal of the American Heart Association.

 

omecamtiv mecarbil (cardiac myosin activator)

 

Participated in a Type C meeting with the FDA that addressed design features of a confirmatory Phase 3 clinical trial of omecamtiv mecarbil with discussion of patient population, endpoints, as well as several additional pragmatic elements related to clinical trial conduct.

 

Advanced preparations to conduct a confirmatory Phase 3 clinical trial of omecamtiv mecarbil in patients with heart failure with reduced ejection fraction (HFrEF) expected to start in Q4 2024.

 

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

 

Announced topline data from the Phase 1 study of CK-586 and expect to present primary data in Q3 2024. Data from the Phase 1 study support progression to a Phase 2a clinical trial in patients with heart failure with preserved ejection fraction (HFpEF) which we expect to start in Q4 2024.

 

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

 

Completed analyses of the Phase 1 study of CK-136, which met its primary objective to assess the safety, tolerability and pharmacokinetics of single and multiple doses of CK-136 in healthy participants. Due to the Company’s strategic prioritization of its other clinical trial programs, further development of CK-136 has been discontinued.

 

Pre-Clinical Development and Ongoing Research

 

Continued pre-clinical development and research activities directed to additional muscle biology focused programs. In 2024, we expect to initiate Phase 1 clinical development of a fast skeletal troponin activator with potential therapeutic application to a specific type of muscular dystrophy.

 

Corporate

 

Hosted the inaugural CLIMB Research Symposium: Contemporary Landscapes In Muscle Biology, a one-day research symposium that brought scientists, researchers and emerging professionals together to share innovative research in the field of muscle biology.

 

Second Quarter 2024 Financial Results

 

Cash, Cash Equivalents and Investments

 

As of June 30, 2024, the company had approximately $1.4 billion in cash, cash equivalents and investments compared to $634.3 million at March 31, 2024. In the second quarter, the company completed a public offering of 11,274,510 shares of its common stock which included the underwriters’ exercise in full of their option to purchase additional shares, raising approximately $563.2 million in net proceeds, after deducting underwriting discounts and commissions. On May 22, 2024, the company entered into a strategic funding collaboration with Royalty Pharma totaling up to $575 million to support the commercialization of aficamten and to advance the company’s expanding cardiovascular pipeline as the company advances its muscle biology-directed specialty cardiology business. The company received $250 million upon execution, including $100 million to fund a confirmatory Phase 3 trial of omecamtiv mecarbil, $50 million to fund a proof-of-concept Phase 2a clinical trial for CK-586, $50 million term loan to support the potential commercial launch of aficamten in obstructive HCM, and $50 million from the purchase of Cytokinetics’ common stock in a private placement. Under the terms of the collaboration, the company, at its option, can borrow up to $175 million upon satisfaction of certain conditions and receive up to $150 million investment in a Phase 3 clinical trial of CK-586 subject to Royalty Pharma exercising its option to participate in the funding of such a trial in exchange for an additional revenue interest in the net sales of CK-586.

 

Revenues

 


Total revenues for the second quarter of 2024 were $0.2 million compared to $0.9 million for the same period in 2023.

 

Research and Development (R&D) Expenses

 

R&D expenses for the second quarter of 2024 were $79.6 million which included $11.5 million of non-cash stock-based compensation expense, compared to $83.2 million for the same period in 2023 which included $8.0 million of non-cash stock-based compensation expense. The decrease was primarily driven by the timing of clinical trial activities and wind down activities for COURAGE-ALS which ended in the first quarter of 2023.

 

General and Administrative (G&A) Expenses

 

G&A expenses for the second quarter of 2024 were $50.8 million which included $13.1 million of non-cash stock-based compensation expense, compared to $39.7 million for the same period in 2023 which included $10.5 million in non-cash stock-based compensation expense. The increase was primarily driven by investments toward commercial readiness and personnel related expenses.

 

Net Income (Loss)

 

Net loss for the second quarter of 2024 was $143.3 million, or $(1.31) per share, basic and diluted, compared to a net loss of $128.6 million, or $(1.34) per share, basic and diluted, for the same period in 2023.

 

2024 Financial Guidance

 

The company is updating its full year 2024 financial guidance:

 

 

Current Guidance

Previous Guidance

GAAP Operating Expense[1]

$555m to $575m

$535m to $555m

Non-cash Expense[2] Included in GAAP Operating Expense

$110m to $105m

$115m to $105m

Non-GAAP Operating Expense[3]

$445m to $470m

$420m to $450m

Net Cash Utilization[4]

$400m to $420m

$390m to $420m

 

The financial guidance does not include the effect of GAAP adjustments caused by events that may occur subsequent to the publication of this guidance including but not limited to business development activities.

 

[1]GAAP operating expense comprised of R&D and G&A expenses.

[2]Non-cash operating expense comprised of stock-based compensation and depreciation.

[3]Non-GAAP operating expense comprised of R&D and G&A expenses but excludes non-cash operating expense.

[4]Net cash utilization is a non-GAAP financial measure that we define as our ending 2023 cash, cash equivalents, and investments balance of $655 million plus the net proceeds of $707 million received from the sale of common stock (through the at-the-market facility, public offerings, and stock purchase agreement with Royalty Pharma) plus proceeds of $200 million received from the structured financing agreement with Royalty Pharma announced on May 22, 2024 minus our projected ending 2024 cash, cash equivalents, and investments balance of between $1,142 million and $1,162 million.


 

Conference Call and Webcast Information

 

Members of Cytokinetics’ senior management team will review the company’s second 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 Q2 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 muscle biology directed drug candidates 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 which were published in the New England Journal of Medicine. 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

 

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, our ability to complete enrollment of ACACIA-HCM in 2025, our ability to start a new Phase 3 confirmatory trial of omecamtiv mecarbil in the fourth quarter of 2024, and to commence a Phase 2a 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, 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.

 

###

 

Contact:

Cytokinetics

Diane Weiser

Senior Vice President, Corporate Affairs

(415) 290-7757


 

 

 

Cytokinetics, Incorporated

Condensed Consolidated Balance Sheets

(in thousands)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

June 30, 2024

 

December 31, 2023

 

 

(unaudited)

 

 

 ASSETS

 

 

 

 

 Current assets:

 

 

 

 

 Cash and short term investments

 

 $ 1,056,775

 

 $ 614,824

 Other current assets

 

                        11,035

 

                        13,227

 Total current assets

 

                   1,067,810

 

                      628,051

 Long-term investments

 

                      305,361

 

                        40,534

 Property and equipment, net

 

                        65,689

 

                        68,748

 Operating lease right-of-use assets

 

                        77,249

 

                        78,987

 Other assets

 

                           7,679

 

                           7,996

 Total assets

 

 $ 1,523,788

 

 $ 824,316

 LIABILITIES AND STOCKHOLDERS’ EQUITY (DEFICIT)

 

 

 

 

 Current liabilities:

 

 

 

 

 Accounts payable and accrued liabilities

 

 $ 49,283

 

 $ 64,148

 Short-term operating lease liabilities

 

                        18,507

 

  17,891

 Current portion of long-term debt

 

                        11,520

 

  10,080

 Derivative liabilities measured at fair value

 

                        13,200

 

  —

 Other current liabilities

 

                        10,267

 

                        10,559

 Total current liabilities

 

                      102,777

 

                      102,678

 Term loan, net

 

  92,831

 

                        58,384

 Convertible notes, net

 

                      550,600

 

                      548,989

 Liabilities related to revenue participation right purchase agreements, net

 

                      435,112

 

                      379,975

 Long-term operating lease liabilities

 

                      116,718

 

                      120,427

 Liabilities related to RPI Transactions measured at fair value

 

                      117,200

 

  —

 Other non-current liabilities

 

  —

 

                              186

 Total liabilities

 

                   1,415,238

 

                   1,210,639

 Commitments and contingencies

 

 

 

 

 Stockholders’ equity (deficit):

 

 

 

 

 Common stock

 

                              117

 

                              102

 Additional paid-in capital

 

                   2,500,654

 

                   1,725,823

 Accumulated other comprehensive loss

 

                         (1,022)

 

                              (10)

 Accumulated deficit

 

                 (2,391,199)

 

                 (2,112,238)

 Total stockholders’ equity (deficit)

 

                      108,550

 

                    (386,323)

 Total liabilities and stockholders’ equity (deficit)

 

 $ 1,523,788

 

 $ 824,316

 

 

 

 


 

 

 

Cytokinetics, Incorporated

Condensed Consolidated Statements of Operations

(in thousands except per share data)

(unaudited)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Three Months Ended

 

 

June 30, 2024

 

June 30, 2023

Revenues:

 

 

 

 

Research and development revenues

 

 $ 249

 

 $ 867

Milestone revenues

 

  —

 

  —

Total revenues

 

                         249

 

                         867

Operating expenses:

 

 

 

 

Research and development

 

                    79,597

 

                    83,194

General and administrative

 

                    50,824

 

                    39,722

Total operating expenses

 

                 130,421

 

                 122,916

Operating loss

 

               (130,172)

 

               (122,049)

Interest expense

 

                  (12,732)

 

                    (7,045)

Non-cash interest expense on liabilities related to revenue participation right purchase agreements

 

  (11,567)

 

  (6,322)

Interest and other income, net

 

                    11,553

 

                      6,779

Change in fair value of derivative liabilities

 

  (600)

 

  —

Change in fair value of liabilities related to RPI Transactions

 

  200

 

  —

Net loss

 

 $ (143,318)

 

 $ (128,637)

Net loss per share — basic and diluted

 

 $ (1.31)

 

 $ (1.34)

Weighted-average number of shares used in computing net loss per share — basic and diluted

 

                 109,240

 

                    95,755