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UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 10-Q
(Mark One)
☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
For the quarterly period ended June 30, 2026
or
☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
For the transition period from to
Commission file number: 000-50633
CYTOKINETICS, INCORPORATED
(Exact name of registrant as specified in its charter)
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Delaware |
94-3291317 |
(State or other jurisdiction of incorporation or organization) |
(I.R.S. Employer Identification No.) |
|
|
350 Oyster Point Blvd. South San Francisco, California |
94080 |
(Address of principal executive offices) |
(Zip Code) |
Registrant’s telephone number, including area code: (650) 624-3000
Securities registered pursuant to Section 12(b) of the Act:
|
|
|
Title of each class Common Stock, $0.001 par value |
Trading symbol CYTK |
Name of each exchange on which registered The Nasdaq Global Select Market |
Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days. Yes ☒ No ☐
Indicate by check mark whether the registrant has submitted electronically every Interactive Data File required to be submitted pursuant to Rule 405 of Regulation S-T (§232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit such files). Yes ☒ No ☐
Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, a smaller reporting company or an emerging growth company. See the definitions of “large accelerated filer,” “accelerated filer,” “smaller reporting company” and “emerging growth company” in Rule 12b-2 of the Exchange Act.
|
|
|
|
|
|
|
|
|
|
Large accelerated filer ☑ |
|
Accelerated filer ☐ |
|
Non-accelerated filer ☐ |
|
Smaller reporting company ☐ |
|
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. ☐
Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act). Yes ☐ No ☒
Number of shares of common stock, $0.001 par value, outstanding as of August 4, 2026: 139,023,418
CYTOKINETICS, INCORPORATED
TABLE OF CONTENTS FOR FORM 10-Q
FOR THE three and six months ended June 30, 2026
Glossary of Terms
Unless the context requires otherwise, references to “Cytokinetics,” “the Company,” “we,” “us” or “our” in this Quarterly Report on Form 10-Q refer to Cytokinetics, Incorporated and its subsidiaries. References to “Notes” in this Form 10-Q are to the Notes to the Condensed Consolidated Financial Statements in this Form 10-Q. We also have used other specific terms in this Form 10-Q, most of which are explained or defined below:
|
|
|
Term/Abbreviation |
|
Definition |
2004 Plan |
|
Cytokinetics’ Amended and Restated 2004 Equity Incentive Plan |
2022 RPI Transactions |
|
The transactions contemplated by the RP Multi Tranche Loan Agreement and the RP Aficamten RPA |
2024 RPI Transactions |
|
The transactions contemplated by the 2024 RP OM Loan Agreement, the RP Ulacamten RPA, the RP Stock Purchase Agreement, the 2022 RP Multi Tranche Loan Agreement Amendment and the RP Aficamten RPA Amendment |
2026 Indenture |
|
Indenture, dated November 13, 2019, between Cytokinetics and U.S. Bank Trust Company (successor in interest to U.S. Bank National Association), as trustee, as supplemented by the First Supplemental Indenture, dated November 13, 2019, between Cytokinetics and U.S. Bank Trust Company (successor in interest to U.S. Bank National Association) |
2026 Notes |
|
Cytokinetics’ 4% convertible senior notes due 2026 |
2027 Indenture |
|
Indenture, dated July 6, 2022, between Cytokinetics and U.S. Bank Trust Company, as trustee |
2027 Notes |
|
Cytokinetics’ 3.50% convertible senior notes due 2027 |
2031 Indenture |
|
Indenture, dated September 19, 2025, between Cytokinetics and U.S. Bank Trust Company, as trustee |
2031 Notes |
|
Cytokinetics’ 1.75% convertible senior notes due 2031 |
ACACIA-HCM |
|
Assessment Comparing Aficamten to Placebo on Cardiac Endpoints In Adults with Non-Obstructive HCM |
AMBER-HFpEF |
|
Our Phase 2 randomized, placebo-controlled, double-blind, multi-center, dose-finding clinical trial in patients with symptomatic HFpEF with left ventricular ejection fraction ≥ 60% |
Amended ATM Facility |
|
Our amended and restated Controlled Equity Offering Sales Agreement |
Astellas FSRA Agreement |
|
Fast Skeletal Regulatory Activator Agreement, dated April 23, 2020 between Cytokinetics and Astellas |
Bayer |
|
Means Bayer AG and/or any affiliate thereof, including Bayer Consumer Care AG |
Bayer License Agreement |
|
Means that certain License and Collaboration Agreement, dated November 18, 2024 by and between the Company and Bayer Consumer Care AG, pursuant to which Bayer acquired an exclusive license to develop and commercialize aficamten in Japan, subject to certain reserved development rights. |
Cantor |
|
Cantor Fitzgerald & Co. |
CEDAR-HCM |
|
Our clinical trial of aficamten in a pediatric population with oHCM |
cGCP |
|
Current Good Clinical Practice |
cGLP |
|
Current Good Laboratory Practice |
cGMP |
|
Current Good Manufacturing Practice |
China |
|
People's Republic of China (including the Hong Kong and Macau SARs) |
CMC |
|
Chemistry, Manufacturing and Controls |
CMO |
|
Contract Manufacturing Organizations |
COMET-HF |
|
Our Phase 3 multi-center, double-blind, randomized, placebo-controlled trial to assess the efficacy and safety of omecamtiv mecarbil in patients with symptomatic HFrEF with severely reduced ejection fraction |
Common Stock |
|
Our common stock, par value $0.001 per share |
Compensation Committee |
|
Compensation and Talent Committee of Cytokinetics’ Board of Directors |
Convertible Notes |
|
2026 Notes, 2027 Notes, and 2031 Notes |
|
|
|
Corxel |
|
Corxel Pharmaceuticals Limited (formerly known as Ji Xing Pharmaceuticals Limited) and/or its affiliates, including Corxel Pharmaceuticals Hong Kong Limited |
Corxel OM License Agreement |
|
Means that certain Collaboration and License Agreement, dated December 20, 2021, by and between the Company and Corxel, pursuant to which we granted Corxel an exclusive license to develop and commercialize omecamtiv mecarbil in China and Taiwan |
COURAGE-ALS |
|
Clinical Outcomes Using Reldesemtiv on ALSFRS-R in a Global Evaluation in ALS |
CRO |
|
Contract Research Organization |
CV |
|
Cardiovascular |
E.U. or EU |
|
European Union |
EMA |
|
European Medicines Agency |
ESPP |
|
Employee Stock Purchase Plan |
ETASU |
|
Elements to assure safe use |
Exchange Act |
|
Securities Exchange Act of 1934, as amended |
FDA |
|
U.S. Food and Drug Administration |
Final Payment Amount |
|
As defined in Part I, Item 2 (Management’s Discussion and Analysis of Financial Conditions and Results of Operations) of this Quarterly Report on Form 10-Q – Sources and Uses of Cash, Royalty Pharma Transactions |
FOREST-HCM |
|
Five-Year, Open-Label, Research Evaluation of Sustained Treatment with Aficamten in HCM |
Fundamental Change |
|
As defined in the 2026 Indenture, 2027 Indenture, or 2031 Indenture, as applicable |
GAAP |
|
Generally Accepted Accounting Principles in the U.S. |
GALACTIC-HF |
|
Global Approach to Lowering Adverse Cardiac Outcomes Through Improving Contractility in Heart Failure |
GDPR |
|
General Data Protection Regulation ((EU) 2016/679) |
HCM |
|
Hypertrophic cardiomyopathy |
HFpEF |
|
Heart failure with preserved ejection fraction |
HFrEF |
|
Heart failure with reduced ejection fraction |
HHS |
|
U.S. Department of Health and Human Services |
HIPAA |
|
The federal Health Insurance Portability and Accountability Act of 1996, as amended by the Health Information Technology for Economic and Clinical Health Act |
IND |
|
Investigational New Drug |
IRA |
|
Inflation Reduction Act of 2022 |
KCCQ |
|
Kansas City Cardiomyopathy Questionnaire |
KCCQ-OSS |
|
KCCQ Overall Summary Score |
LVEF |
|
Left ventricular ejection fraction |
LVOT |
|
Left ventricular outflow tract |
LVOT-G |
|
Left ventricular outflow tract gradient |
MAA |
|
Marketing Authorization Application |
MAPLE-HCM |
|
Metoprolol vs Aficamten in Patients with LVOT Obstruction on Exercise Endpoints Capacity in HCM |
NDA |
|
New Drug Application |
nHCM |
|
Non-obstructive HCM |
NOLs |
|
Net operating loss carryforward |
NYHA |
|
New York Heart Association |
oHCM |
|
Obstructive HCM |
|
|
|
Oyster Point Lease |
|
Lease, dated July 24, 2019, by and between Cytokinetics and KR Oyster Point 1, LLC, as amended |
Partial Redemption Limitation |
|
As defined in the 2027 Indenture and 2031 Indenture, as applicable |
PSU |
|
Performance Stock Unit |
Radnor Lease |
|
As defined in Part I, Item 1 (Financial Statements (Unaudited)), Notes to Condensed Consolidated Financial Statements of this Quarterly Report on Form 10-Q - Note 9 (Commitments and Contingencies) – Operating Leases |
REMS |
|
Risk Evaluation and Mitigation Strategy |
RP Aficamten RPA |
|
Revenue Participation Right Purchase Agreement, dated January 7, 2022, by and between Cytokinetics and Royalty Pharma Investments 2019 ICAV |
RP Aficamten RPA Amendment |
|
Amendment No. 1, dated May 22, 2024, to Revenue Participation Right Purchase Agreement, dated January 7, 2022, by and between Cytokinetics and Royalty Pharma Investments 2019 ICAV |
RP Ulacamten RPA |
|
Ulacamten Revenue Participation Right Purchase Agreement, dated May 22, 2024, by and between Cytokinetics and Royalty Pharma Investments 2019 ICAV |
RP Multi Tranche Loan Agreement |
|
Development Funding Loan Agreement, dated January 7, 2022, by and among Royalty Pharma Development Funding, LLC and Cytokinetics |
RP Multi Tranche Loan Agreement Amendment |
|
Third Amendment, dated May 22, 2024, to Development Funding Loan Agreement, dated January 7, 2022, by and among Royalty Pharma Development Funding, LLC and Cytokinetics |
RP OM Liability |
|
As defined in Part I, Item 1 (Financial Statements (Unaudited)), Notes to Condensed Consolidated Financial Statements of this Quarterly Report on Form 10-Q - Note 3 (Agreements with Royalty Pharma) – 2017 RP Omecamtiv Mecarbil Royalty Purchase Agreement |
RP OM Loan Agreement |
|
2024 Development Funding Loan Agreement, dated May 22, 2024, by and among Royalty Pharma Development Funding, LLC and Cytokinetics |
RP OM RPA |
|
Royalty Purchase Agreement, dated February 1, 2017, by and between Cytokinetics and RPI Finance Trust, as amended by Amendment No. 1, dated January 7, 2022 |
RP Stock Purchase Agreement |
|
Common Stock Option and Purchase Agreement, dated May 22, 2024, by and between Cytokinetics and Royalty Pharma Investments 2019 ICAV |
RPDF |
|
Royalty Pharma Development Funding, LLC |
RPFT |
|
RPI Finance Trust |
RPI ICAV |
|
Royalty Pharma Investments 2019 ICAV |
RSU |
|
Restricted Stock Unit |
Sanofi |
|
Means Sanofi S.A. and/or any affiliates thereof, including Genzyme Corporation |
Sanofi License Agreement |
|
Means that certain License and Collaboration Agreement, dated July 14, 2020 by and between the Company and Sanofi (as assignee of Corxel), pursuant to which Sanofi has an exclusive license to develop and commercialize aficamten in China and Taiwan |
Section 382 |
|
Section 382 of the Internal Revenue Code |
Securities Act |
|
Securities Act of 1933, as amended |
SEQUOIA-HCM |
|
Safety, Efficacy, and Quantitative Understanding of Obstruction Impact of Aficamten in HCM |
SGLT2 |
|
Sodium-glucose cotransporter-2 |
U.S. or US |
|
United States of America |
This Form 10-Q includes discussion of certain clinical studies relating to various in-line products and/or product candidates. These studies typically are part of a larger body of clinical data relating to such products or product candidates, and the discussion herein should be considered in the context of the larger body of data. In addition, clinical trial data are subject to differing interpretations, and, even when we view data as sufficient to support the safety and/or effectiveness of a product candidate or a new indication for an in-line product, regulatory authorities may not share our views and may require additional data or may deny approval altogether.
CYTOKINETICS and our C-shaped logo are registered trademarks of Cytokinetics in the U.S. and certain other countries. Other service marks, trademarks and trade names referred to in this report are the property of their respective owners.
The information contained on our website, our Facebook, Instagram, YouTube and LinkedIn pages or our X (formerly Twitter) accounts, or any third-party website, is not incorporated by reference into this Form 10-Q.
PART I. FINANCIAL INFORMATION
ITEM 1. FINANCIAL STATEMENTS
CYTOKINETICS, INCORPORATED
CONDENSED CONSOLIDATED BALANCE SHEETS
(In thousands) (Unaudited)
|
|
|
|
|
|
|
|
|
|
|
June 30, 2026 |
|
|
December 31, 2025 |
|
ASSETS |
|
|
|
|
|
|
Current assets: |
|
|
|
|
|
|
Cash and cash equivalents |
|
$ |
255,271 |
|
|
$ |
122,518 |
|
Short-term investments |
|
|
910,415 |
|
|
|
759,703 |
|
Accounts receivable, net |
|
|
24,432 |
|
|
|
17,764 |
|
Inventories |
|
|
380 |
|
|
|
— |
|
Prepaid expenses and other current assets |
|
|
17,989 |
|
|
|
16,990 |
|
Total current assets |
|
|
1,208,487 |
|
|
|
916,975 |
|
Long-term investments |
|
|
538,317 |
|
|
|
335,048 |
|
Property and equipment, net |
|
|
78,916 |
|
|
|
79,194 |
|
Operating lease right-of-use assets |
|
|
72,896 |
|
|
|
75,979 |
|
Inventories, long-term |
|
|
6,529 |
|
|
|
— |
|
Other assets |
|
|
19,406 |
|
|
|
17,341 |
|
Total assets |
|
$ |
1,924,551 |
|
|
$ |
1,424,537 |
|
LIABILITIES AND STOCKHOLDERS’ DEFICIT |
|
|
|
|
|
|
Current liabilities: |
|
|
|
|
|
|
Accounts payable |
|
$ |
20,510 |
|
|
$ |
22,337 |
|
Accrued liabilities |
|
|
76,862 |
|
|
|
83,278 |
|
Short-term operating lease liabilities |
|
|
21,042 |
|
|
|
19,111 |
|
Current portion of convertible and long-term debt |
|
|
27,358 |
|
|
|
41,181 |
|
Derivative liabilities measured at fair value |
|
|
30,700 |
|
|
|
31,100 |
|
Deferred revenue |
|
|
1,653 |
|
|
|
1,612 |
|
Other current liabilities |
|
|
3,304 |
|
|
|
3,833 |
|
Total current liabilities |
|
|
181,429 |
|
|
|
202,452 |
|
Term loans, net |
|
|
248,202 |
|
|
|
246,384 |
|
Convertible notes, net |
|
|
871,527 |
|
|
|
869,597 |
|
Liabilities related to revenue participation right purchase agreements, net |
|
|
558,054 |
|
|
|
520,559 |
|
Long-term operating lease liabilities |
|
|
102,426 |
|
|
|
107,970 |
|
Liabilities related to RPI Transactions measured at fair value |
|
|
136,400 |
|
|
|
137,200 |
|
Total liabilities |
|
|
2,098,038 |
|
|
|
2,084,162 |
|
Commitments and contingencies |
|
|
|
|
|
|
Stockholders' deficit |
|
|
|
|
|
|
Preferred stock |
|
|
— |
|
|
|
— |
|
Common stock |
|
|
138 |
|
|
|
123 |
|
Additional paid-in capital |
|
|
3,721,713 |
|
|
|
2,826,341 |
|
Accumulated other comprehensive (loss) income |
|
|
(3,826 |
) |
|
|
630 |
|
Accumulated deficit |
|
|
(3,891,512 |
) |
|
|
(3,486,719 |
) |
Total stockholders' deficit |
|
|
(173,487 |
) |
|
|
(659,625 |
) |
Total liabilities and stockholders' deficit |
|
$ |
1,924,551 |
|
|
$ |
1,424,537 |
|
The accompanying notes are an integral part of these condensed consolidated financial statements.
CYTOKINETICS, INCORPORATED
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS
(In thousands, except per share data) (Unaudited)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended |
|
|
Six Months Ended |
|
|
|
June 30, 2026 |
|
|
June 30, 2025 |
|
|
June 30, 2026 |
|
|
June 30, 2025 |
|
Revenues: |
|
|
|
|
|
|
|
|
|
|
|
|
Net product revenue |
|
$ |
25,334 |
|
|
$ |
— |
|
|
$ |
30,123 |
|
|
$ |
— |
|
Collaboration revenues |
|
|
3,290 |
|
|
|
2,416 |
|
|
|
5,927 |
|
|
|
3,995 |
|
License and milestone revenues |
|
|
— |
|
|
|
64,353 |
|
|
|
11,929 |
|
|
|
64,353 |
|
Total revenues |
|
|
28,624 |
|
|
|
66,769 |
|
|
|
47,979 |
|
|
|
68,348 |
|
Operating expenses: |
|
|
|
|
|
|
|
|
|
|
|
|
Research and development |
|
|
97,807 |
|
|
|
110,138 |
|
|
|
193,332 |
|
|
|
208,400 |
|
Selling, general and administrative |
|
|
104,397 |
|
|
|
65,721 |
|
|
|
209,293 |
|
|
|
123,090 |
|
Cost of goods sold |
|
|
2,731 |
|
|
|
— |
|
|
|
2,891 |
|
|
|
— |
|
Collaboration cost of revenues |
|
|
2,861 |
|
|
|
2,416 |
|
|
|
5,253 |
|
|
|
3,995 |
|
Total operating expenses |
|
|
207,796 |
|
|
|
178,275 |
|
|
|
410,769 |
|
|
|
335,485 |
|
Operating loss |
|
|
(179,172 |
) |
|
|
(111,506 |
) |
|
|
(362,790 |
) |
|
|
(267,137 |
) |
Interest and other expense, net |
|
|
(14,654 |
) |
|
|
(11,084 |
) |
|
|
(29,173 |
) |
|
|
(19,952 |
) |
Non-cash interest expense on liabilities related to revenue participation right purchase agreements |
|
|
(20,177 |
) |
|
|
(13,181 |
) |
|
|
(38,993 |
) |
|
|
(27,259 |
) |
Interest and other income, net |
|
|
13,941 |
|
|
|
13,001 |
|
|
|
24,963 |
|
|
|
26,702 |
|
Change in fair value of derivative liabilities |
|
|
(1,100 |
) |
|
|
3,000 |
|
|
|
400 |
|
|
|
2,600 |
|
Change in fair value of liabilities related to RPI Transactions |
|
|
2,400 |
|
|
|
(14,600 |
) |
|
|
800 |
|
|
|
(10,700 |
) |
Net loss |
|
$ |
(198,762 |
) |
|
$ |
(134,370 |
) |
|
$ |
(404,793 |
) |
|
$ |
(295,746 |
) |
Net loss per share — basic and diluted |
|
$ |
(1.50 |
) |
|
$ |
(1.12 |
) |
|
$ |
(3.17 |
) |
|
$ |
(2.49 |
) |
Weighted-average number of shares used in computing net loss per share — basic and diluted |
|
|
132,086 |
|
|
|
119,457 |
|
|
|
127,704 |
|
|
|
118,979 |
|
Other comprehensive (loss) gain: |
|
|
|
|
|
|
|
|
|
|
|
|
Unrealized loss on available-for-sale securities, net |
|
|
(1,770 |
) |
|
|
(851 |
) |
|
|
(3,608 |
) |
|
|
(1,392 |
) |
Foreign currency translation adjustments |
|
|
(444 |
) |
|
|
(852 |
) |
|
|
(848 |
) |
|
|
(1,164 |
) |
Comprehensive loss |
|
$ |
(200,976 |
) |
|
$ |
(136,073 |
) |
|
$ |
(409,249 |
) |
|
$ |
(298,302 |
) |
The accompanying notes are an integral part of these condensed consolidated financial statements.
CYTOKINETICS, INCORPORATED
CONDENSED CONSOLIDATED STATEMENTS OF STOCKHOLDERS’ (Deficit) equity
(In thousands, except share data) (Unaudited)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Common Stock |
|
|
Additional Paid-In |
|
|
Accumulated Other Comprehensive |
|
|
Accumulated |
|
|
Total Stockholders’ |
|
|
|
Shares |
|
|
Amount |
|
|
Capital |
|
|
Loss |
|
|
Deficit |
|
|
Deficit |
|
Balance, December 31, 2025 |
|
|
122,943,172 |
|
|
$ |
123 |
|
|
$ |
2,826,341 |
|
|
$ |
630 |
|
|
$ |
(3,486,719 |
) |
|
$ |
(659,625 |
) |
Exercise of stock options |
|
|
403,208 |
|
|
|
— |
|
|
|
11,346 |
|
|
|
— |
|
|
|
— |
|
|
|
11,346 |
|
Vesting of restricted stock units, net of taxes withheld |
|
|
891,443 |
|
|
|
1 |
|
|
|
(841 |
) |
|
|
— |
|
|
|
— |
|
|
|
(840 |
) |
Stock-based compensation |
|
|
— |
|
|
|
— |
|
|
|
30,824 |
|
|
|
— |
|
|
|
— |
|
|
|
30,824 |
|
Unrealized loss on available-for-sale securities, net |
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
(1,838 |
) |
|
|
— |
|
|
|
(1,838 |
) |
Foreign currency translation adjustments |
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
(404 |
) |
|
|
— |
|
|
|
(404 |
) |
Net loss |
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
(206,031 |
) |
|
|
(206,031 |
) |
Balance, March 31, 2026 |
|
|
124,237,823 |
|
|
|
124 |
|
|
|
2,867,670 |
|
|
|
(1,612 |
) |
|
|
(3,692,750 |
) |
|
|
(826,568 |
) |
Exercise of stock options |
|
|
968,077 |
|
|
|
1 |
|
|
|
33,657 |
|
|
|
— |
|
|
|
— |
|
|
|
33,658 |
|
Vesting of restricted stock units, net of taxes withheld |
|
|
137,636 |
|
|
|
— |
|
|
|
(1,527 |
) |
|
|
— |
|
|
|
— |
|
|
|
(1,527 |
) |
Issuance of common stock under Employee Stock Purchase Plan |
|
|
77,383 |
|
|
|
— |
|
|
|
4,344 |
|
|
|
— |
|
|
|
— |
|
|
|
4,344 |
|
Issuance of common stock in public offering, net of issuance costs |
|
|
11,338,028 |
|
|
|
11 |
|
|
|
760,137 |
|
|
|
— |
|
|
|
— |
|
|
|
760,148 |
|
Issuance of common stock upon conversion of convertible notes |
|
|
2,002,817 |
|
|
|
2 |
|
|
|
21,065 |
|
|
|
— |
|
|
|
— |
|
|
|
21,067 |
|
Stock-based compensation |
|
|
— |
|
|
|
— |
|
|
|
36,367 |
|
|
|
— |
|
|
|
— |
|
|
|
36,367 |
|
Unrealized loss on available-for-sale securities, net |
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
(1,770 |
) |
|
|
— |
|
|
|
(1,770 |
) |
Foreign currency translation adjustments |
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
(444 |
) |
|
|
— |
|
|
|
(444 |
) |
Net loss |
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
(198,762 |
) |
|
|
(198,762 |
) |
Balance, June 30, 2026 |
|
|
138,761,764 |
|
|
$ |
138 |
|
|
$ |
3,721,713 |
|
|
$ |
(3,826 |
) |
|
$ |
(3,891,512 |
) |
|
$ |
(173,487 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Common Stock |
|
|
Additional Paid-In |
|
|
Accumulated Other Comprehensive |
|
|
Accumulated |
|
|
Total Stockholders’ |
|
|
|
Shares |
|
|
Amount |
|
|
Capital |
|
|
(Loss) Income |
|
|
Deficit |
|
|
Deficit |
|
Balance, December 31, 2024 |
|
|
118,209,139 |
|
|
$ |
118 |
|
|
$ |
2,563,876 |
|
|
$ |
2,398 |
|
|
$ |
(2,701,764 |
) |
|
$ |
(135,372 |
) |
Exercise of stock options |
|
|
351,985 |
|
|
|
— |
|
|
|
7,651 |
|
|
|
— |
|
|
|
— |
|
|
|
7,651 |
|
Vesting of restricted stock units, net of taxes withheld |
|
|
659,179 |
|
|
|
1 |
|
|
|
(13 |
) |
|
|
— |
|
|
|
— |
|
|
|
(12 |
) |
Stock-based compensation |
|
|
— |
|
|
|
— |
|
|
|
23,549 |
|
|
|
— |
|
|
|
— |
|
|
|
23,549 |
|
Unrealized loss on available-for-sale securities, net |
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
(541 |
) |
|
|
— |
|
|
|
(541 |
) |
Foreign currency translation adjustments |
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
(312 |
) |
|
|
— |
|
|
|
(312 |
) |
Net loss |
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
(161,376 |
) |
|
|
(161,376 |
) |
Balance, March 31, 2025 |
|
|
119,220,303 |
|
|
|
119 |
|
|
|
2,595,063 |
|
|
|
1,545 |
|
|
|
(2,863,140 |
) |
|
|
(266,413 |
) |
Exercise of stock options |
|
|
219,077 |
|
|
|
— |
|
|
|
3,868 |
|
|
|
— |
|
|
|
— |
|
|
|
3,868 |
|
Vesting of restricted stock units, net of taxes withheld |
|
|
55,056 |
|
|
|
— |
|
|
|
(514 |
) |
|
|
— |
|
|
|
— |
|
|
|
(514 |
) |
Issuance of common stock under Employee Stock Purchase Plan |
|
|
109,116 |
|
|
|
— |
|
|
|
2,877 |
|
|
|
— |
|
|
|
— |
|
|
|
2,877 |
|
Stock-based compensation |
|
|
— |
|
|
|
— |
|
|
|
27,535 |
|
|
|
— |
|
|
|
— |
|
|
|
27,535 |
|
Unrealized loss on available-for-sale securities, net |
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
(851 |
) |
|
|
— |
|
|
|
(851 |
) |
Foreign currency translation adjustments |
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
(852 |
) |
|
|
— |
|
|
|
(852 |
) |
Net loss |
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
(134,370 |
) |
|
|
(134,370 |
) |
Balance, June 30, 2025 |
|
|
119,603,552 |
|
|
$ |
119 |
|
|
$ |
2,628,829 |
|
|
$ |
(158 |
) |
|
$ |
(2,997,510 |
) |
|
$ |
(368,720 |
) |
The accompanying notes are an integral part of these condensed consolidated financial statements.
CYTOKINETICS, INCORPORATED
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS
(In thousands) (Unaudited)
|
|
|
|
|
|
|
|
|
|
|
Six Months Ended |
|
|
|
June 30, 2026 |
|
|
June 30, 2025 |
|
Cash flows from operating activities: |
|
|
|
|
|
|
Net loss |
|
$ |
(404,793 |
) |
|
$ |
(295,746 |
) |
Adjustments to reconcile net loss to net cash used in operating activities: |
|
|
|
|
|
|
Non-cash interest expense on liabilities related to revenue participation right purchase agreements |
|
|
38,993 |
|
|
|
27,311 |
|
Stock-based compensation expense |
|
|
66,105 |
|
|
|
51,084 |
|
Non-cash lease expense |
|
|
3,210 |
|
|
|
2,566 |
|
Depreciation of property and equipment |
|
|
7,009 |
|
|
|
4,585 |
|
Change in fair value of derivative liabilities |
|
|
(400 |
) |
|
|
(2,600 |
) |
Change in fair value of liabilities related to RPI Transactions |
|
|
(800 |
) |
|
|
10,700 |
|
Realized gain on investment, net |
|
|
(121 |
) |
|
|
(16 |
) |
Interest receivable and amortization on investments |
|
|
(6,226 |
) |
|
|
(10,206 |
) |
Non-cash interest expense related to debt |
|
|
17,186 |
|
|
|
8,783 |
|
Changes in operating assets and liabilities: |
|
|
|
|
|
|
Accounts receivable |
|
|
(6,668 |
) |
|
|
8,240 |
|
Prepaid and other assets |
|
|
(2,786 |
) |
|
|
(5,013 |
) |
Inventories |
|
|
(5,823 |
) |
|
|
— |
|
Accounts payable |
|
|
1,549 |
|
|
|
(3,626 |
) |
Deferred revenue |
|
|
41 |
|
|
|
(51,026 |
) |
Accrued and other liabilities |
|
|
(966 |
) |
|
|
(382 |
) |
Operating lease liabilities |
|
|
(3,742 |
) |
|
|
(4,466 |
) |
Other non-current liabilities |
|
|
(7,065 |
) |
|
|
(41 |
) |
Net cash used in operating activities |
|
|
(305,297 |
) |
|
|
(259,853 |
) |
Cash flows from investing activities: |
|
|
|
|
|
|
Purchases of investments |
|
|
(833,781 |
) |
|
|
(382,071 |
) |
Investment in non-marketable equity security |
|
|
— |
|
|
|
(5,000 |
) |
Maturities of investments |
|
|
482,539 |
|
|
|
549,725 |
|
Sales of investments |
|
|
— |
|
|
|
5,992 |
|
Purchases of property and equipment |
|
|
(10,264 |
) |
|
|
(9,809 |
) |
Net cash (used in) provided by investing activities |
|
|
(361,506 |
) |
|
|
158,837 |
|
Cash flows from financing activities: |
|
|
|
|
|
|
Repayment of finance lease liabilities |
|
|
— |
|
|
|
(204 |
) |
Repayment of term loans |
|
|
(6,329 |
) |
|
|
(5,378 |
) |
Payments of royalty obligations |
|
|
(214 |
) |
|
|
— |
|
Proceeds from RPI Transactions |
|
|
— |
|
|
|
75,000 |
|
Proceeds from issuance of common stock related to public offering, net of issuance costs |
|
|
760,149 |
|
|
|
— |
|
Proceeds from issuance of common stock under equity incentive and stock purchase plans |
|
|
49,348 |
|
|
|
14,396 |
|
Taxes paid related to net share settlement of equity awards |
|
|
(2,327 |
) |
|
|
(527 |
) |
Net cash provided by financing activities |
|
|
800,627 |
|
|
|
83,287 |
|
Effect of exchange rate changes on cash |
|
|
(1,078 |
) |
|
|
(952 |
) |
Net increase (decrease) in cash, cash equivalents, and restricted cash |
|
|
132,746 |
|
|
|
(18,681 |
) |
Cash, cash equivalents, and restricted cash, beginning of period |
|
|
125,632 |
|
|
|
95,232 |
|
Cash, cash equivalents, and restricted cash, end of period |
|
$ |
258,378 |
|
|
$ |
76,551 |
|
Supplemental cash flow disclosures: |
|
|
|
|
|
|
Cash paid for interest |
|
$ |
12,194 |
|
|
$ |
10,253 |
|
Non-cash investing and financing activities: |
|
|
|
|
|
|
Right-of-use assets recognized in exchange for operating lease obligations |
|
$ |
170 |
|
|
$ |
3,501 |
|
Amounts unpaid for purchases of property and equipment |
|
$ |
113 |
|
|
$ |
2,830 |
|
Conversion of 2026 Notes |
|
$ |
21,067 |
|
|
$ |
— |
|
The accompanying notes are an integral part of these condensed consolidated financial statements.
CYTOKINETICS, INCORPORATED
NOTES TO UNAUDITED CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
Note 1 — Organization and Significant Accounting Policies
Cytokinetics, Incorporated was incorporated under the laws of the state of Delaware on August 5, 1997. We are a biopharmaceutical company focused on discovering, developing and commercializing novel muscle activators and muscle inhibitors as potential treatments for debilitating diseases in which muscle performance is compromised and/or declining. Our flagship commercial product is MYQORZO® (aficamten), 5 mg, 10 mg, 15 mg, and 20 mg tablets for the treatment of adults with oHCM to improve functional capacity and symptoms, which the FDA approved in December 2025 and which first became available for prescription to patients in the first quarter of 2026. In addition, in February 2026, the European Commission approved MYQORZO® (aficamten), 5 mg, 10 mg, 15 mg and 20 mg tablets for the treatment of symptomatic (New York Heart Association, NYHA, class II-III) oHCM in adult patients and which first became available for prescription to patients in Germany in the second quarter of 2026. Moreover, in December 2025, the China National Medical Products Administration approved MYQORZO for the treatment of adults with (New York Heart Association class II-III) oHCM, to improve exercise capacity and symptoms. MYQORZO first became available to patients in China in the first quarter of 2026 under the Sanofi License Agreement.
Our financial statements contemplate the conduct of our operations in the normal course of business. We have incurred an accumulated deficit of approximately $3.9 billion since inception and there can be no assurance that we will attain profitability. We had a net loss of $404.8 million and net cash used in operations of $305.3 million for the six months ended June 30, 2026. Cash, cash equivalents, and investments was $1.7 billion as of June 30, 2026. We anticipate that we will have operating losses and net cash outflows in future periods.
We are subject to risks common to biopharmaceutical companies including, but not limited to, development of new drug candidates, dependence on key personnel, commercialization of our drugs and the ability to obtain additional capital as needed to fund our future plans. Our liquidity will be impaired if sufficient additional capital is not available on terms acceptable to us. To date, we have funded operations primarily through sales of our common stock, contract payments under our collaboration agreements, sales of future revenues and royalties, debt financing arrangements, and interest income, but we will increasingly rely on revenues generated from the commercial sales of MYQORZO to fund our operations and cash expenditures. We commenced commercial sales in the first quarter of 2026, but there can be no assurance as to the timing or level of revenues from such sales. Until we achieve profitable operations, we intend to continue to fund operations through payments from strategic collaborations, additional sales of equity securities, and debt financings in addition to our commercial sales revenue.
Our success is dependent on our ability to obtain additional capital by entering into financings or new strategic collaborations, and ultimately on our and our collaborators’ ability to successfully develop and market our drugs and drug candidates. We cannot be certain that sufficient funds will be available from financings or such collaborators when needed or on satisfactory terms. Additionally, there can be no assurance that MYQORZO or any of our drug candidates will be accepted in the marketplace or that any future products can be developed or manufactured at an acceptable cost. These factors could have a material adverse effect on our future financial results, financial position and cash flows.
Based on the current status of our research and development and commercialization activities, we believe that our existing cash, cash equivalents and investments will be sufficient to fund cash requirements for at least the next 12 months after the issuance of this Quarterly Report on Form 10-Q. If, at any time, our prospects for financing our research and development programs decline, we may decide to reduce research and development expenses by delaying, discontinuing or reducing our funding of one or more of our research or development programs. Alternatively, we might raise funds through strategic collaborations, public or private financings or other arrangements. Such funding, if needed, may not be available on favorable terms, or at all. The financial statements do not include any adjustments that might result from the outcome of this uncertainty.
Our condensed consolidated financial statements include the accounts of Cytokinetics and our wholly-owned subsidiaries. The accompanying unaudited condensed consolidated financial statements have been prepared in accordance with GAAP for interim financial information and the instructions to Form 10-Q and Rule 10-01 of Regulation S-X. The financial statements include all adjustments (consisting only of normal recurring adjustments) that management believes are necessary for the fair statement of our financial information. These interim results are not necessarily indicative of results to be expected for the full fiscal year or any future interim period. The balance sheet as of December 31, 2025 has been derived from the audited financial statements at that date but does not include all of the information and footnotes required by GAAP for complete financial statements. The interim condensed financial statements should be read in conjunction with the audited financial statements and notes thereto contained in the Company’s Form 10-K for the year ended December 31, 2025, as filed with the Securities and Exchange Commission.
Reclassification of prior periods
Certain comparative figures have been reclassified to conform to the current period presentation. Specifically, $2.4 million and $4.0 million previously reported research and development expenses in the three and six months ended June 30, 2025, respectively, have been reclassified to collaboration cost of revenues. These reclassifications had no effect on the previously reported total assets, total liabilities, or net income.
Use of Estimates
The preparation of condensed consolidated financial statements in conformity with GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosures of contingent assets and liabilities at the date of the condensed consolidated financial statements and the reported amounts of revenues and expenses during the reporting periods. We evaluate our estimates on an ongoing basis. We base our estimates on our historical experience and on assumptions that we believe are reasonable; however, actual results could significantly differ from those estimates.
Investment in non-marketable equity security
During the first quarter of 2025, we made an equity investment of $5.0 million that does not have a readily determinable fair value. We have elected the measurement alternative under which we measure the investment at cost, less any impairment. If we observe price changes in orderly transactions for identical or similar securities of the same issuer, we will remeasure the investment at fair value as of the date of the observable transaction. As of June 30, 2026, the investment has a carrying value of $5.0 million and is classified as “Other assets” on the condensed consolidated balance sheet.
Net Product Revenue
Our first commercial product MYQORZO® (aficamten), was approved by the FDA in December 2025. MYQORZO is an allosteric and reversible inhibitor of cardiac myosin motor activity. The approval of MYQORZO included a risk evaluation and mitigation strategy (REMS) program intended to support a favorable benefit-risk profile in light of the risk of heart failure due to systolic dysfunction. In patients with oHCM, myosin inhibition with MYQORZO reduces cardiac contractility and left ventricular outflow tract obstruction. The Company enters into agreements with specialty pharmacies and specialty distributors (each a “Customer” and collectively the “Customers”) to sell MYQORZO in the United States and Europe. Revenues from product sales are recognized when the Customer obtains control of the Company’s product, which occurs at a point in time, typically upon delivery to the Customer.
Revenue is recorded net of variable consideration, which includes prompt pay discounts, returns, chargebacks, rebates, and co-payment assistance. These deductions to product sales are referred to as gross-to-net deductions and are estimated and recorded in the period in which the related product sales occur. The variable consideration is estimated based on contractual terms as well as management assumptions. The amount of variable consideration is calculated by using the expected value method. Estimates are reviewed quarterly and adjusted as necessary. Taxes assessed by governmental authorities and collected from customers are excluded from product sales.
Accruals are established for gross to net deductions and actual amounts incurred are offset against applicable accruals. The Company reflects these accruals as either a reduction in the related account receivable from the customer or as an accrued liability, depending on the means by which the deduction is settled. Sales deductions are based on management’s estimates that involve a substantial degree of judgment.
Prompt Pay and Distributor Fees: Customers receive a prompt pay discount for payments made within a contractually agreed number of days before the due date. Customers may receive a contractually agreed upon distribution fee. Both of these discounts are accounted for as a reduction of the transaction price and recorded as a contra receivable.
Returns: We typically permit returns if the product is damaged, defective, or otherwise cannot be used by the customer. We typically permit returns six months prior to and up to one year after the product expiration date. The Company records allowances for product returns as a reduction of revenue at the time product sales are recorded. Product returns are estimated based on industry data. A returns reserve is recorded as an accrued liability.
Rebates and Chargebacks: Rebates and chargebacks include amounts due to payers and healthcare providers under various programs based on contractual arrangements or statutory requirements, which may vary by payer and individual plans. Providers qualified under certain programs can purchase our products through our specialty pharmacies and distributors at a discount. The specialty pharmacies or distributors then charge the discount back to us.
Rebates and chargebacks are estimated primarily based on product sales, historical and estimated payer mix and discount rates, among other inputs, which require significant estimates and judgment. Since we launched our first commercial product in the first quarter of 2026, we do not have historical data and we are relying on industry information. We assess and update our estimates each reporting period to reflect actual claims and other current information.
Co-Payment Assistance: Co-payment assistance programs are offered to eligible end-users as price concessions and are recorded as accrued liabilities and a reduction of the transaction price. The Company uses a third-party to administer the co-payment program for pharmacy benefit claims. Our accrual for co-pay assistance programs is based on an estimate of claims and the cost per claim that we expect to receive associated with inventory that exists in the distribution channel at period end.
The Company generates revenue from a small number of specialty pharmacies and specialty distributors. The following customers accounted for over 10% of total gross product revenue during the three and six months ended June 30, 2026. As the Company launched MYQORZO in January 2026, there were no sales in prior periods.
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended |
|
|
Six Months Ended |
|
|
|
June 30, 2026 |
|
|
June 30, 2025 |
|
|
June 30, 2026 |
|
|
June 30, 2025 |
|
Customer A |
|
|
34 |
% |
|
|
0 |
% |
|
|
32 |
% |
|
|
0 |
% |
Customer B |
|
|
36 |
% |
|
|
0 |
% |
|
|
37 |
% |
|
|
0 |
% |
Customer C |
|
|
23 |
% |
|
|
0 |
% |
|
|
24 |
% |
|
|
0 |
% |
Accounts Receivable, net
The Company's trade accounts receivable arise from product sales and represent amounts due from its customers. In addition, the Company records accounts receivable arising from its collaboration and licensing agreements. The Company provides allowances against receivables for estimated losses, if any, that may result from a counterparty's inability to pay. Amounts determined to be uncollectible are written-off against the allowance.
Inventories
Inventories, which consist of raw materials, work in process and finished goods, are stated at the lower of cost or estimated net realizable value, using standard costs, based on a first-in, first-out method. We have entered into manufacturing and supply agreements for the manufacture or purchase of raw materials and production supplies in prior years. Our inventories include the direct purchase cost of materials and supplies, charges from contract manufacturing organizations and manufacturing overhead costs. We will periodically review our inventories for factors that could impact the future recoverability and realization of future sales, which require estimates and judgments. We will analyze our inventory levels quarterly and write down inventories subject to expiry, in excess of expected requirements or that has a cost basis in excess of its expected net realizable value. These write downs will be charged to cost of goods sold in the accompanying consolidated statements of operations and comprehensive loss.
We received FDA approval for MYQORZO on December 19, 2025 and began capitalizing inventories upon FDA approval. Costs incurred prior to approval have been recorded as research and development expense in our consolidated statement of operations and comprehensive loss. As a result, inventory balances and cost of goods sold for the next several quarters are expected to reflect a lower average per unit cost of materials.
Note 2 — Net Loss Per Share
The following instruments were excluded from the computation of diluted net loss per share for the periods presented because their effect would have been antidilutive (in thousands):
|
|
|
|
|
|
|
|
|
|
|
June 30, 2026 |
|
|
June 30, 2025 |
|
Options to purchase common stock |
|
|
10,776 |
|
|
|
11,621 |
|
Restricted stock and performance units |
|
|
2,941 |
|
|
|
2,441 |
|
Shares issuable related to the ESPP |
|
|
16 |
|
|
|
22 |
|
Shares issuable upon conversion of 2026 Notes |
|
|
— |
|
|
|
2,003 |
|
Shares issuable upon conversion of 2027 Notes |
|
|
2,751 |
|
|
|
10,572 |
|
Shares issuable upon conversion of 2031 Notes |
|
|
10,962 |
|
|
|
— |
|
Total shares |
|
|
27,446 |
|
|
|
26,659 |
|
During the three months ended June 30, 2026, holders converted the remaining $21.1 million aggregate principal amount of the 2026 Notes into 2,002,817 shares of the Company's common stock. There are no outstanding 2026 Convertible Notes as of June 30, 2026.
Note 3 — Agreements with Royalty Pharma
On January 7, 2022, we entered into the 2022 RPI Transactions with affiliates of Royalty Pharma International plc. Pursuant to the 2022 RPI Transactions, the RP Multi Tranche Loan Agreement and the RP Aficamten RPA described below, are determined to be debt instruments subsequently measured at amortized cost and were entered into with parties that were at the time of our entry into the 2022 RPI Transactions affiliated and in contemplation of one another. We used the relative fair value method and made separate estimates of the fair value of each freestanding financial instrument and then allocated the proceeds in proportion to those fair value amounts. Arrangement consideration for the RP Multi Tranche Loan Agreement and the RP Aficamten RPA totaled $150 million, consisting of the two $50 million up front payments for the signing of the RP Multi Tranche Loan Agreement and the RP Aficamten RPA and milestone of $50 million for the initiation of the first pivotal trial in oHCM for aficamten that was deemed probable at the signing of the agreements.
On May 22, 2024, we entered into the 2024 RPI Transactions with affiliates of Royalty Pharma International plc, which included an amendment to the RP Aficamten RPA, a component of the 2022 RPI Transactions. The 2024 RPI Transactions include the 2024 RP OM Loan Agreement, the RP Ulacamten RPA, the RP Stock Purchase Agreement, the RP Multi Tranche Loan Agreement Amendment and the RP Aficamten RPA Amendment, as described below, are accounted for as a debt modification of the 2022 RPI Transactions.
Liabilities Related to RPI Transactions Measured at Fair Value
As permitted under ASC 825, we elected the fair value option for recognizing the liabilities related to the 2024 RP OM Loan Agreement and the RP Ulacamten RPA. The fair value option was elected because these liabilities included embedded derivatives which would have otherwise required separate recognition and measurement. The Company elected the fair value option as it is believed to be more practical for each liability as a single unit of account at fair value. Under the fair value option, debt issuance costs are expensed as incurred and the Company is required to record the fair value option elected arrangements at their fair value on the date of issuance and at each balance sheet thereafter. Changes in the estimated fair value of the arrangements are recognized as changes in fair value of liabilities related to RPI Transactions in the condensed consolidated statement of operations and comprehensive loss.
Accounting for RPI Transactions Measured at Fair Value
The fair values of the liabilities for the RP OM Loan Agreement and RP Ulacamten RPA are based on significant unobservable inputs, including the probability of clinical success and regulatory approval based on historical industry success rates for product development specific to cardiovascular products, the estimated date of a product launch, estimates of pricing, sales ramp, variables for the timing of the related events, probability of change of control, and discount rates (which ranged from 14% to 17% and 12% to 17% for the three and six months ended June 30, 2026, respectively, and 10% to 18% for the three and six months ended June 30, 2025), which are deemed to be Level 3 inputs in the fair value hierarchy. As products containing omecamtiv mecarbil and ulacamten have not yet been commercialized, the estimates are highly subjective. For example, assumed increases in the probability of the clinical success for the omecamtiv mecarbil or ulacamten programs could increase the value of the liabilities. Similarly, assumed decreases in the discount rates used in the fair value measurements could also increase the value of the liabilities at period end.
The Company recorded a gain of $2.4 million and $0.8 million for the three and six months ended June 30, 2026, respectively, and a loss of $14.6 million and $10.7 million for the three and six months ended June 30, 2025, respectively, associated with the change in fair value of the liabilities related to 2024 RP OM Loan Agreement and the RP Ulacamten RPA. The change in the fair value has been recognized in the condensed consolidated statement of operations and comprehensive loss.
The following tables summarize the changes of the fair value of the RP Ulacamten RPA and RP OM Loan (in thousands):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2026 |
|
|
2025 |
|
|
|
RP Ulacamten RPA |
|
|
RP OM Loan |
|
|
RP Ulacamten RPA |
|
|
RP OM Loan |
|
Beginning balance, January 1 |
|
$ |
13,700 |
|
|
$ |
123,500 |
|
|
$ |
14,000 |
|
|
$ |
123,000 |
|
Change in fair value |
|
|
(200 |
) |
|
|
1,800 |
|
|
|
(300 |
) |
|
|
(3,600 |
) |
Ending balance, March 31 |
|
|
13,500 |
|
|
|
125,300 |
|
|
|
13,700 |
|
|
|
119,400 |
|
Change in fair value |
|
|
(300 |
) |
|
|
(2,100 |
) |
|
|
300 |
|
|
|
14,300 |
|
Ending balance, June 30 |
|
$ |
13,200 |
|
|
$ |
123,200 |
|
|
$ |
14,000 |
|
|
$ |
133,700 |
|
Liabilities Related to Revenue Participation Right Purchase Agreements
RP Aficamten Royalty Purchase Agreement
The carrying amount of the RP Aficamten Liability is based on our estimate of the future royalties to be paid to RPI ICAV over the life of the arrangement as discounted using an imputed rate of interest. In the second quarter of 2024, we recorded an additional $33.3 million to the carrying value related to the 2024 RPI Transactions entered into May 22, 2024. The imputed rate of interest on the carrying value of the RP Aficamten Liability was approximately 26.1% as of June 30, 2026 and 20.5% as of June 30, 2025.
2017 RP Omecamtiv Mecarbil Royalty Purchase Agreement
The carrying amount of the RP OM Liability is based on our estimate of the future royalties to be paid to RPFT over the life of the arrangement as discounted using an imputed rate of interest. The excess of future estimated royalty payments over the $92.3 million of allocated proceeds, less issuance costs, is recognized as non-cash interest expense using the effective interest method. The imputed rate of interest on the RP OM Liability is reassessed periodically and is not reduced below 0%. The imputed rate of interest on the carrying value of the RP OM Liability was 0.0% as of June 30, 2026 and 0.1% as of June 30, 2025.
Accounting for Revenue Participation Right Purchase Agreements
We periodically assess the amount and timing of expected royalty payments using a combination of internal projections and forecasts from external sources. The RP OM Liability and the RP Aficamten Liability are measured using the effective interest method based on estimates of future royalty payments over the life of the arrangements. To the extent such payments are greater or less than our initial estimates or the timing of such payments is materially different than its original estimates, we will prospectively adjust the amortization of the RP OM Liability and the RP Aficamten Liability and the effective interest rate. A significant change to unobservable inputs could also result in a material increase or decrease to the effective interest rate of the liabilities. Note, for the RP OM Liability, the effective interest rate is reassessed periodically and will not be reduced below 0%.
There are a number of factors that could materially affect the amount and timing of royalty payments, a number of which are not within our control. The RP OM Liability and the RP Aficamten Liability are recognized using significant unobservable inputs. The estimates of future royalties require the use of several assumptions such as: the probability of clinical success, the probability of regulatory approval, the estimated date of a product launch, estimates of eligible patient populations, estimates of prescribing behavior and patient compliance behavior, estimates of pricing, payor reimbursement and coverage, and sales ramp. A significant change in unobservable inputs could result in a material increase or decrease to the effective interest rate of the RP OM Liability and the RP Aficamten Liability.
We review our assumptions on a regular basis and our estimates may change in the future as we refine and reassess our assumptions. Changes to the RP Aficamten Liability and the RP OM Liability are as follows (in thousands):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2026 |
|
|
2025 |
|
|
|
RP Aficamten Liability |
|
|
RP OM Liability |
|
|
RP Aficamten Liability |
|
|
RP OM Liability |
|
Beginning balance, January 1 |
|
$ |
320,764 |
|
|
$ |
199,795 |
|
|
$ |
262,599 |
|
|
$ |
199,593 |
|
Interest accretion |
|
|
18,816 |
|
|
|
— |
|
|
|
14,037 |
|
|
|
41 |
|
Amortization of issuance costs |
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
26 |
|
Ending balance, March 31 |
|
|
339,580 |
|
|
|
199,795 |
|
|
|
276,636 |
|
|
|
199,660 |
|
Interest accretion |
|
|
20,177 |
|
|
|
— |
|
|
|
13,140 |
|
|
|
41 |
|
Amortization of issuance costs |
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
26 |
|
Royalty payment |
|
|
(214 |
) |
|
|
— |
|
|
|
— |
|
|
|
— |
|
Ending balance, June 30 |
|
$ |
359,543 |
|
|
$ |
199,795 |
|
|
$ |
289,776 |
|
|
$ |
199,727 |
|
Approximately $1.3 million of the RP Aficamten Liability balance is recorded in short term accrued liabilities based upon the royalties currently due from the most recent quarter sales.
RP Multi Tranche Term Loan
Tranche 7 under the RP Multi Tranche Loan Agreement Amendment for $175.0 million is drawable at Cytokinetics’ discretion within one year of FDA approval of aficamten in oHCM.
As of June 30, 2026, the estimated fair value of the Tranche 1, Tranche 4, Tranche 5, and Tranche 6 term loans was $259.3 million. The fair value was estimated based on Level 3 inputs.
Derivative Liabilities Measured at Fair Value
We have bifurcated and recognized the embedded derivatives in the RP Multi Tranche Loan Agreement. These embedded derivatives include repayment features based upon a change in control.
The fair values of the derivative liabilities are determined using the probability-weighted expected return method and the “with and without” method. The fair values are based on significant unobservable inputs, including the probability of change of control, the probability of default (less than 10%), discount rates (ranging from 14% to 15% and 12% to 15% for the three and six months ended June 30, 2026, respectively, and 10% to 12% and 10% to 14% for the three and six months ended June 30, 2025, respectively) and other factors.
The following table summarizes the changes in the fair value of the derivative liabilities for the RP Multi Tranche Loan Agreement (in thousands):
|
|
|
|
|
|
|
|
|
|
|
RP Multi Tranche Loan Agreement Derivatives |
|
|
|
2026 |
|
|
2025 |
|
Beginning balance, January 1 |
|
$ |
31,100 |
|
|
$ |
11,300 |
|
Change in fair value |
|
|
(1,500 |
) |
|
|
400 |
|
Ending balance, March 31 |
|
|
29,600 |
|
|
|
11,700 |
|
Settlement |
|
|
— |
|
|
|
(3,900 |
) |
Initial measurement |
|
|
— |
|
|
|
12,800 |
|
Change in fair value |
|
|
1,100 |
|
|
|
(3,000 |
) |
Ending balance, June 30 |
|
$ |
30,700 |
|
|
$ |
17,600 |
|
Note 4 — Research and Development Arrangements
Collaboration for Commercialization of Aficamten in Greater China
Effective December 17, 2024, Sanofi has an exclusive license to develop and commercialize aficamten in China and Taiwan (the "Sanofi License Agreement"). The total maximum development and commercial milestone payments achievable for development and commercial milestone events in the field of oHCM and nHCM are $160.0 million, of which we have already earned $10.0 million in 2024 and $15.0 million in 2025, following regulatory approval of MYQORZO by the National Medical Products Administration ("NMPA") in China and the FDA in the United States. We are also entitled to receive tiered royalties in the low-to-high teens range on the net sales of pharmaceutical products containing aficamten in China and Taiwan, subject to certain reductions for generic competition, patent expiration and payments for licenses to third party patents.
The Sanofi License Agreement will, unless terminated earlier, continue on a market-by-market basis until expiration of the relevant royalty term.
Collaboration revenues for China were $0.8 million and $1.2 million for the three and six months ended June 30, 2026, respectively, related to certain development cost reimbursements, along with an insignificant amount of royalty revenue. Collaboration revenues were not material for the three and six months ended June 30, 2025. Accounts receivable from Sanofi was $0.4 million as of June 30, 2026 and $15.1 million as of December 31, 2025.
Collaboration for Commercialization of Aficamten in Japan
On November 19, 2024, we announced that we had entered into a collaboration and license agreement with Bayer Consumer Care AG, an affiliate of Bayer AG, for the exclusive development and commercialization of aficamten in Japan, subject to certain reserved development rights of Cytokinetics to continue to conduct certain clinical trials (the "Bayer License Agreement").
License and milestone revenues from Bayer was none and $11.9 million for the three and six months ended June 30, 2026, respectively, and $64.3 million for the three and six months ended June 30, 2025. The amount recognized in the six months ended June 30, 2026 relates to the milestone achievement of the first commercial sale of MYQORZO in the United States. Milestones associated with the first dosing of aficamten to the first patient in Japan in a Phase 3 clinical trial in nHCM and in a Phase 3 clinical trial in oHCM were achieved in 2025 and recognized as revenue in 2025. The first dose of aficamten in Japan in a Phase 3 clinical trial in nHCM occurred in June 2025 and the first dose of aficamten in Japan in a Phase 3 clinical trial in oHCM occurred in August 2025. There are no outstanding receivables related to license and milestone revenues from Bayer as of June 30, 2026.
The Company earned €10.0 million in the first quarter of 2026 and remains eligible to receive up to an additional €70.0 million upon achievement of development and commercial milestones. The Company is also eligible to receive up to an additional €490.0 million in commercial milestone payments upon the achievement of certain sales milestones, and tiered royalties on net sales of aficamten in Japan.
Collaboration revenues from Bayer were $2.5 million and $4.7 million for the three and six months ended June 30, 2026, respectively, and $2.4 million and $3.9 million for the three and six months ended June 30, 2025, respectively, related to certain research and development cost reimbursements. We had accounts receivable from Bayer of $2.5 million as of June 30, 2026, and $2.6 million as of December 31, 2025.
We re-evaluate the probability of achievement of development milestones and any related constraints each reporting period. We will include consideration, without constraint, in the transaction price to the extent it is probable that a significant reversal in the amount of cumulative revenue recognized will not occur.
Research Collaboration
In May 2025, we entered into a research collaboration where we will reimburse our collaborative research partner for their research expenses. The reimbursement of research expenses was $1.5 million and $2.7 million for the three and six months ended June 30, 2026, respectively, which were recorded as research and development. There was no reimbursement of research expenses for the three and six months ended June 30, 2025. Subject to the terms of the agreement, our collaborative research partner may receive potential research, development and commercial milestone and royalty payments from us and we may develop and commercialize development candidates.
As of June 30, 2026, the collaborative partner under this collaboration provided a data package, which resulted in the achievement of a specified preclinical development milestone. Accordingly, the Company has recorded a liability of $2.5 million in accrued liabilities on the condensed consolidated balance sheet in anticipation of paying the milestone in the third quarter of 2026.
Note 5 — Fair Value Measurements
We value our financial assets and liabilities at fair value, defined as the price that would be received for assets when sold or paid to transfer a liability in an orderly transaction between market participants at the measurement date (exit price). We utilize market data or assumptions that we believe market participants would use in pricing the asset or liability, including assumptions about risk and the risks inherent in the inputs to the valuation technique. These inputs can be readily observable, market corroborated or generally unobservable.
We primarily apply the market approach for recurring fair value measurements and endeavor to utilize the best information reasonably available. Accordingly, we use valuation techniques that maximize the use of observable inputs and minimize the use of unobservable inputs to the extent possible and consider the security issuers’ and the third-party issuers’ credit risk in our assessment of fair value.
We classify fair value based on the observability of those inputs using a hierarchy that prioritizes the inputs used to measure fair value. The hierarchy gives the highest priority to unadjusted quoted prices in active markets for identical assets or liabilities (Level 1 measurement) and the lowest priority to unobservable inputs (Level 3 measurement):
Level 1 — Observable inputs, such as quoted prices in active markets for identical assets or liabilities;
Level 2 — Inputs, other than the quoted prices in active markets, that are observable either directly or through corroboration with observable market data; and
Level 3 — Unobservable inputs, for which there is little or no market data for the assets or liabilities, such as internally-developed valuation models.
Fair Value of Financial Assets:
The following tables set forth the fair value of our financial assets, which consists of cash equivalents and investments classified as available-for-sale securities, that were measured on a recurring basis (in thousands):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
June 30, 2026 |
|
|
|
Fair Value Hierarchy Level |
|
Amortized Cost |
|
|
Unrealized Gains |
|
|
Unrealized Losses |
|
|
Fair Value |
|
Money market funds |
|
Level 1 |
|
$ |
150,838 |
|
|
$ |
— |
|
|
$ |
— |
|
|
$ |
150,838 |
|
U.S. Treasury securities |
|
Level 1 |
|
|
356,077 |
|
|
|
47 |
|
|
|
(436 |
) |
|
|
355,688 |
|
U.S. Government agency securities |
|
Level 2 |
|
|
270,636 |
|
|
|
— |
|
|
|
(813 |
) |
|
|
269,823 |
|
Commercial paper |
|
Level 2 |
|
|
435,841 |
|
|
|
6 |
|
|
|
(475 |
) |
|
|
435,372 |
|
Asset-backed securities |
|
Level 2 |
|
|
7,687 |
|
|
|
— |
|
|
|
(3 |
) |
|
|
7,684 |
|
Corporate obligations |
|
Level 2 |
|
|
420,824 |
|
|
|
68 |
|
|
|
(830 |
) |
|
|
420,062 |
|
|
|
|
|
$ |
1,641,903 |
|
|
$ |
121 |
|
|
$ |
(2,557 |
) |
|
$ |
1,639,467 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
December 31, 2025 |
|
|
|
Fair Value Hierarchy Level |
|
Amortized Cost |
|
|
Unrealized Gains |
|
|
Unrealized Losses |
|
|
Fair Value |
|
Money market funds |
|
Level 1 |
|
$ |
89,509 |
|
|
$ |
— |
|
|
$ |
— |
|
|
$ |
89,509 |
|
U.S. Treasury securities |
|
Level 1 |
|
|
239,097 |
|
|
|
574 |
|
|
|
(7 |
) |
|
|
239,664 |
|
U.S. Government agency securities |
|
Level 2 |
|
|
201,788 |
|
|
|
162 |
|
|
|
(38 |
) |
|
|
201,912 |
|
Commercial paper |
|
Level 2 |
|
|
289,447 |
|
|
|
96 |
|
|
|
(26 |
) |
|
|
289,517 |
|
Asset-backed securities |
|
Level 2 |
|
|
7,579 |
|
|
|
7 |
|
|
|
— |
|
|
|
7,586 |
|
Corporate obligations |
|
Level 2 |
|
|
363,645 |
|
|
|
457 |
|
|
|
(53 |
) |
|
|
364,049 |
|
|
|
|
|
$ |
1,191,065 |
|
|
$ |
1,296 |
|
|
$ |
(124 |
) |
|
$ |
1,192,237 |
|
Investments in corporate debt securities, commercial paper, asset-backed securities and U.S. Government agency securities are classified as Level 2 as they are valued based upon quoted market prices for similar instruments in active markets, quoted prices for identical or similar instruments in markets that are not active and model-based valuation techniques for which all significant inputs are observable in the market or can be corroborated by observable market data for substantially the full term of the assets. Where applicable, these models project future cash flows and discount the future amounts to a present value using market-based observable inputs obtained from various third-party data providers, including but not limited to benchmark yields, interest rate curves, reported trades, broker/dealer quotes and reference data.
No credit losses on debt securities were recognized in the periods presented. In its evaluation to determine expected credit losses, management considered all available historical and current information, expectations of future economic conditions, the type of security, the credit rating of the security, and the size of the loss position, as well as other relevant information. The unrealized losses as of June 30, 2026 are attributed to market interest rate changes and are not attributed to credit. The Company does not intend to sell any of these available-for-sale investments before their effective maturity or market price recovery.
Note 6 — Balance Sheet Components
Cash, cash equivalents, and restricted cash
A reconciliation of cash, cash equivalents, and restricted cash reported in the accompanying condensed consolidated balance sheets to the amount reported within the accompanying condensed consolidated statements of cash flows was as follows (in thousands):
|
|
|
|
|
|
|
|
|
|
|
June 30, 2026 |
|
|
December 31, 2025 |
|
Cash and cash equivalents |
|
$ |
255,271 |
|
|
$ |
122,518 |
|
Restricted cash |
|
|
3,107 |
|
|
|
3,114 |
|
Total cash, cash equivalents, and restricted cash as reported within our condensed consolidated statement of cash flows |
|
$ |
258,378 |
|
|
$ |
125,632 |
|
As of June 30, 2026, the Company's restricted cash balance of $3.1 million is used to collateralize certain credit instruments.
Accounts receivable, net
Accounts receivable, net was as follows (in thousands):
|
|
|
|
|
|
|
|
|
|
|
June 30, 2026 |
|
|
December 31, 2025 |
|
Accounts receivable, net: |
|
|
|
|
|
|
Net product receivables |
|
$ |
21,517 |
|
|
$ |
— |
|
Collaboration receivables |
|
|
2,915 |
|
|
|
17,764 |
|
Total accounts receivable, net |
|
$ |
24,432 |
|
|
$ |
17,764 |
|
Inventories
Inventories were as follows (in thousands):
|
|
|
|
|
|
|
|
|
|
|
June 30, 2026 |
|
|
December 31, 2025 |
|
Inventories: |
|
|
|
|
|
|
Raw materials |
|
$ |
5,535 |
|
|
$ |
— |
|
Work in process |
|
|
994 |
|
|
|
— |
|
Finished goods |
|
|
380 |
|
|
|
— |
|
Total inventories |
|
$ |
6,909 |
|
|
$ |
— |
|
Inventories, long-term, are comprised of raw materials and work in process that are expected to be sold beyond the next 12 months.
Accrued liabilities
Accrued liabilities were as follows (in thousands):
|
|
|
|
|
|
|
|
|
|
|
June 30, 2026 |
|
|
December 31, 2025 |
|
Accrued liabilities: |
|
|
|
|
|
|
Clinical and preclinical costs |
|
$ |
21,166 |
|
|
$ |
24,561 |
|
Compensation related |
|
|
34,338 |
|
|
|
45,150 |
|
Other accrued expenses |
|
|
21,358 |
|
|
|
13,567 |
|
Total accrued liabilities |
|
$ |
76,862 |
|
|
$ |
83,278 |
|
Note 7 — Debt
Convertible Notes
2031 Notes
The following table presents the total amount of interest cost recognized relating to the 2031 Notes (in thousands):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended |
|
|
Six Months Ended |
|
|
|
June 30, 2026 |
|
|
June 30, 2025 |
|
|
June 30, 2026 |
|
|
June 30, 2025 |
|
Contractual interest expense |
|
$ |
3,281 |
|
|
$ |
— |
|
|
$ |
6,562 |
|
|
$ |
— |
|
Amortization of debt issuance costs |
|
|
794 |
|
|
|
— |
|
|
|
1,540 |
|
|
|
— |
|
Total interest expense recognized |
|
$ |
4,075 |
|
|
$ |
— |
|
|
$ |
8,102 |
|
|
$ |
— |
|
The effective interest rate of the 2031 Notes was 2.23% as of June 30, 2026. As of June 30, 2026, the unamortized debt issuance cost for the 2031 Notes was $18.1 million and will be amortized over approximately 5.3 years.
2027 Notes
The following table presents the total amount of interest cost recognized relating to the 2027 Notes (in thousands):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended |
|
|
Six Months Ended |
|
|
|
June 30, 2026 |
|
|
June 30, 2025 |
|
|
June 30, 2026 |
|
|
June 30, 2025 |
|
Contractual interest expense |
|
$ |
1,230 |
|
|
$ |
4,725 |
|
|
$ |
2,460 |
|
|
$ |
9,451 |
|
Amortization of debt issuance costs |
|
|
222 |
|
|
|
817 |
|
|
|
426 |
|
|
|
1,563 |
|
Total interest expense recognized |
|
$ |
1,452 |
|
|
$ |
5,542 |
|
|
$ |
2,886 |
|
|
$ |
11,014 |
|
The effective interest rate of the 2027 Notes was 4.2% as of June 30, 2026 and 2025. As of June 30, 2026, the unamortized debt issuance cost for the 2027 Notes was $0.9 million and will be amortized over approximately 1.0 years. During the three months ended June 30, 2026, the conditions allowing holders of the 2027 Notes to convert were met. As a result, the 2027 Notes are convertible as of June 30, 2026.
As of June 30, 2026, the estimated fair value of the 2031 Notes and 2027 Notes was $1.1 billion and $239.8 million, respectively, and was based upon observable, Level 2 inputs, including pricing information from recent trades of the Convertible Notes.
2026 Notes
The following table presents the total amount of interest cost recognized relating to the 2026 Notes (in thousands):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended |
|
|
Six Months Ended |
|
|
|
June 30, 2026 |
|
|
June 30, 2025 |
|
|
June 30, 2026 |
|
|
June 30, 2025 |
|
Contractual interest expense |
|
$ |
102 |
|
|
$ |
211 |
|
|
$ |
313 |
|
|
$ |
422 |
|
Amortization of debt issuance costs |
|
|
15 |
|
|
|
29 |
|
|
|
42 |
|
|
|
55 |
|
Total interest expense recognized |
|
$ |
117 |
|
|
$ |
240 |
|
|
$ |
355 |
|
|
$ |
477 |
|
During the three months ended June 30, 2026, holders converted the remaining $21.1 million aggregate principal amount of the 2026 Notes into 2,002,817 shares of the Company's common stock, together with an immaterial amount of cash paid in lieu of fractional shares. The conversions were completed in accordance with the original conversion terms of the 2026 Notes, and no gain or loss was recognized. As of June 30, 2026, the 2026 Notes were fully converted and no principal amount remained outstanding.
The effective interest rate of the 2026 Notes was 4.6% before the conversion in May 2026 and as of June 30, 2025.
Note 8 — Stockholders’ Equity
Equity Incentive Plan
Our 2004 Plan provides for us to grant incentive stock options, non-statutory stock options, restricted stock, stock appreciation rights, restricted stock units, performance shares and performance units to employees, directors, and consultants. We may grant options for terms of up to ten years at prices not lower than 100% of the fair market value of our common stock on the date of grant. Options granted to new employees generally vest 25% after one year and monthly thereafter over a period of four years. Options granted to existing employees generally vest monthly over a period of four years.
Our annual grant of stock-based compensation takes place during the first quarter of each year. Our stock options and restricted stock units granted during the first quarter of 2026 were as follows:
|
|
|
|
|
|
|
|
|
|
|
Grants |
|
|
Weighted Average Grant Date Fair Value per Share |
|
Stock options |
|
|
1,518,443 |
|
|
$ |
60.20 |
|
Restricted stock units |
|
|
1,460,603 |
|
|
$ |
60.16 |
|
In May 2025, our stockholders approved an amendment to the 2004 Plan to increase the number of authorized shares reserved for issuance under the 2004 Plan by an additional 5.0 million shares.
As of June 30, 2026, the total authorized shares under the 2004 Plan available for grant were 3.8 million.
Total stock-based compensation expense was recorded in the condensed consolidated statements of operations and comprehensive loss, and allocated as follows (in thousands):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended |
|
|
Six Months Ended |
|
|
|
June 30, 2026 |
|
|
June 30, 2025 |
|
|
June 30, 2026 |
|
|
June 30, 2025 |
|
Research and development |
|
$ |
15,935 |
|
|
$ |
13,542 |
|
|
$ |
29,516 |
|
|
$ |
25,220 |
|
Selling, general and administrative |
|
|
19,776 |
|
|
|
13,993 |
|
|
|
36,589 |
|
|
|
25,864 |
|
|
|
$ |
35,711 |
|
|
$ |
27,535 |
|
|
$ |
66,105 |
|
|
$ |
51,084 |
|
For the three and six months ended June 30, 2026, we capitalized approximately $0.7 million and $1.1 million, respectively, of stock-based compensation into inventories.
Performance Stock Units
During 2025 through the second quarter of 2026, the Compensation Committee granted a total of 759,182 performance stock units ("PSUs") to certain employees with a grant date fair value ranging from $44.36 to $71.38 per unit. The fair value of the PSUs was determined on the grant date based on the fair value of the Company’s common stock at such time. The PSU awards are subject to performance goals and will be earned as to a pre-determined fixed number of shares subject to the certification by the Compensation and Talent Committee of the Company’s Board of Directors (the “Compensation Committee”) that the Company has achieved one or more of the relevant performance goals, in each case vesting as to 50% of the earned shares on applicable Compensation Committee certification date and as to the remaining 50% of the earned shares following the one-year anniversary of the applicable Compensation Committee certification date.
The Company recognized expense for the PSUs of $1.8 million and $2.3 million for the three and six months ended June 30, 2026, respectively, compared to a credit of $1.1 million and an immaterial amount of expense for the three and six months ended June 30, 2025, respectively. There was $11.2 million of unamortized stock-based compensation related to the portion of PSUs vesting that is deemed probable as of June 30, 2026.
Public Offering of Common Stock
On May 8, 2026, the Company closed an underwritten public offering of 11,338,028 shares of common stock at a public offering price of $71.00 per share, which included the exercise in full by the underwriters of their option to purchase up to 1,478,873 shares of common stock at the public offering price. The net proceeds to the Company from the offering were approximately $760.1 million, after deducting underwriting discounts and commissions and offering expenses payable by the Company.
Controlled Equity Offering Sales Agreement
On February 27, 2025, we entered into an Open Market Sale AgreementSM with Jefferies LLC under which we may offer and sell, from time to time, at our sole discretion, shares of common stock in “at the market offerings” pursuant to Rule 415(a)(4) under the Securities Act of 1933 through Jefferies LLC, as sales agent. As of June 30, 2026, we have not sold any shares of common stock under the Open Market Sale AgreementSM with Jefferies LLC.
Note 9 — Commitments and Contingencies
Legal Matters
From time to time, the Company is a party to legal proceedings in the course of the Company's business. The outcome of such matters is inherently uncertain and often involves significant judgment in assessing risk and estimating potential exposure. Accruals are recognized for legal matters when a loss is both probable and reasonably estimable. As of June 30, 2026, no material contingent liabilities have been recognized. If a material loss is reasonably possible and we can estimate the amount or range of the loss, we disclose such information. Unless otherwise noted, either the outcome of these matters is not expected to be material, or the potential loss cannot be reasonably estimated.
In re Cytokinetics, Incorporated Securities Litigation
On September 17, 2025, a putative stockholder class action lawsuit was filed against the Company and its Chief Executive Officer in the United States District Court for the Northern District of California, alleging violations of Sections 10(b) and 20(a) of the Securities Exchange Act of 1934. The action was purportedly filed on behalf of a class consisting of all investors who purchased or otherwise acquired the Company's common stock between December 27, 2023 and May 6, 2025. The complaint alleges that the Company made materially false and misleading statements regarding the timeline for the NDA regulatory approval process for aficamten and failed to disclose related material risks. The complaint seeks unspecified damages, together with interest, attorneys' fees, and costs.
On December 22, 2025, the Court appointed Gilbert Rosenthal as Lead Plaintiff and approved his selection of Pomerantz LLP as Lead Counsel. The action is now captioned In re Cytokinetics, Incorporated Securities Litigation, Case No. 3:25-cv-07923-RFL. On March 10, 2026, Lead Plaintiff filed an amended complaint, which, among other things, added the Company's Chief Financial Officer as a defendant. The Company filed a motion to dismiss the amended complaint and Lead Plaintiff filed an opposition to the motion. The Company expects to file a reply to the opposition in due course.
The Company and the individual defendants dispute the allegations in the amended complaint and intend to vigorously defend against the action.
Pohlmann v. Blum, et al.
On March 9, 2026, a purported stockholder derivative action captioned Pohlmann v. Blum, et al., Case No. 3:26-cv-01998-RFL, was filed in the United States District Court for the Northern District of California against certain of the Company's current and former directors and its Chief Executive Officer, with the Company named as a nominal defendant. The complaint asserts claims for breach of fiduciary duty, aiding and abetting breach of fiduciary duty, unjust enrichment, waste of corporate assets, contribution under the Securities Exchange Act of 1934, and violations of Section 14(a) of the Securities Exchange Act of 1934 and Rule 14a-9 promulgated thereunder. The allegations are based substantially on the same underlying facts and circumstances as those alleged In re Cytokinetics, Incorporated Securities Litigation and principally concern statements regarding the Company's New Drug Application for aficamten and the subsequent extension of the related PDUFA action date. The complaint seeks, among other relief, unspecified damages on behalf of the Company, disgorgement, corporate governance reforms, and attorneys' fees and costs.
On March 27, 2026, the Court found the derivative action to be related to In re Cytokinetics, Incorporated Securities Litigation and reassigned the matter accordingly. On April 16, 2026, the Court entered an order, pursuant to the parties' stipulation, staying the derivative action in its entirety during the pendency of any motion to dismiss in the securities class action, subject to customary terms.
The Company and the individual defendants dispute the allegations in the derivative action and intend to vigorously defend against the matter.
Other Commitment
We have approximately $18.6 million of non-cancellable commitments related to purchases of materials and inventory manufacturing agreements.
ITEM 2. MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS
This discussion and analysis should be read in conjunction with our financial statements and accompanying notes included elsewhere in this report. Operating results are not necessarily indicative of results that may occur in future periods.
This report contains forward-looking statements indicating expectations about future performance and other forward-looking statements within the meaning of Section 27A of the Securities Act, Section 21E of the Exchange Act, and the Private Securities Litigation Reform Act of 1995, that involve risks and uncertainties. All statements other than statements of historical fact, including statements concerning our plans, objectives, goals, strategies, future events, future revenues or performance, financing needs, expectations, plans or intentions relating to clinical development, product candidates, the regulatory approval process, our commercialization efforts for MYQORZO, products and markets, and business trends and other information referred to under the “Risk Factors” and “Management’s Discussion and Analysis of Financial Condition and Results of Operations,” are forward-looking statements. In some cases, you can identify forward-looking statements by terms such as “anticipate,” “assume,” “believe,” “commitment,” “could,” “estimate,” “expect,” “forecast,” “intend,” “may,” “plan,” “potential,” “predict,” “project,” “should,” “target,” “will,” “would,” “seek” and similar expressions intended to identify forward-looking statements. We have made these statements in reliance on the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Forward-looking statements are subject to certain risks and uncertainties, which could cause actual results, outcomes, and the timing of events to differ materially from the results discussed in the forward-looking statements.
In addition, these forward-looking statements are subject to the risks and uncertainties discussed in the “Risk Factors” section and elsewhere in this document. Such statements speak only as of the date on which they are made, and, except as required by law, we undertake no obligation to update any forward-looking statement to reflect events or circumstances after the date on which the statement is made or to reflect the occurrence of unanticipated events. New factors emerge from time to time, and it is not possible for us to predict which factors will arise. In addition, we cannot assess the impact of each factor on our business or the extent to which any factor, or combination of factors, may cause actual results to differ materially from those contained in any forward-looking statements.
In addition, statements that “we believe” and similar statements reflect our beliefs and opinions on the relevant subject. These statements are based upon information available to us as of the date of this Quarterly Report on Form 10-Q, and while we believe such information forms a reasonable basis for such statements, such information may be limited or incomplete, and our statements should not be read to indicate that we have conducted an exhaustive inquiry into, or review of, all potentially available relevant information. These statements are inherently uncertain and investors are cautioned not to unduly rely upon these statements.
Overview
We are a biopharmaceutical company focused on discovering, developing and commercializing novel muscle activators and muscle inhibitors as potential treatments for debilitating diseases in which muscle performance is compromised and/or declining. We have discovered and are developing muscle-directed investigational medicines that may potentially improve the health span of people with devastating cardiovascular and neuromuscular diseases of impaired muscle function. Our first commercial product is MYQORZO® (aficamten), 5 mg, 10 mg, 15 mg, and 20 mg tablets, which the FDA approved in December 2025. MYQORZO is an allosteric and reversible inhibitor of cardiac myosin motor activity. The approval of MYQORZO included a risk evaluation and mitigation strategy program, otherwise known as a REMS, intended to support a favorable benefit-risk profile in light of the risk of heart failure due to systolic dysfunction. In patients with oHCM, myosin inhibition with MYQORZO reduces cardiac contractility and left ventricular outflow tract obstruction. MYQORZO became available for prescription to patients on or around January 27, 2026. In addition, in February 2026, the European Commission approved MYQORZO® (aficamten), 5 mg, 10 mg, 15 mg and 20 mg tablets for the treatment of symptomatic (New York Heart Association, NYHA, class II-III) oHCM in adult patients. In July 2026, the Medicines and Healthcare products Regulatory Agency (MHRA) granted MYQORZO marketing authorization across the United Kingdom for the treatment of symptomatic oHCM in adult patients. Moreover, in December 2025, the China National Medical Products Administration approved MYQORZO for the treatment of adults with (New York Heart Association class II-III) oHCM, to improve exercise capacity and symptoms.
Behind MYQORZO, we are making disciplined pipeline investments in investigational products that are at discovery, preclinical and clinical stages of research and development. All our research and development activities relate to the biology of muscle function and have evolved from our knowledge and expertise regarding the cytoskeleton, a complex biological infrastructure that plays a fundamental role within every human cell. As a leader in muscle biology and the mechanics of muscle performance, we are discovering and developing small molecule drug candidates specifically engineered to impact muscle function and contractility with the objective of building a sustainable specialty biopharmaceutical business.
Our specific focus on the biology of the cytoskeleton distinguishes us from other biopharmaceutical companies and potentially positions us to identify or discover and develop and commercialize novel therapeutics that may be useful for the treatment of severe diseases and medical conditions. We intend to leverage our experience in muscle contractility to expand our current pipeline and expect to identify additional potential drug candidates that may be suitable for clinical development and commercialization.
Cytokinetics’ Marketed Product: MYQORZO®
MYQORZO® (aficamten), is a novel, oral, small molecule cardiac myosin inhibitor that our scientists discovered for the treatment of symptomatic oHCM. MYQORZO was designed to reduce the hypercontractility associated with HCM. In preclinical models, MYQORZO reduces myocardial contractility by binding directly to cardiac myosin at a distinct and selective allosteric binding site, thereby preventing myosin from entering a force producing state. MYQORZO reduces the number of active actin-myosin cross bridges during each cardiac cycle and consequently reduces myocardial contractility.
HCM is the most common monogenic inherited cardiovascular disorder, with well over 300,000 patients diagnosed in the U.S. However, there are an estimated 400,000-800,000 additional patients who remain undiagnosed. The diagnosis rate for oHCM is growing at approximately the same rate as the population, while the diagnosis rate for nHCM has been increasing with recent year-over-year growth estimated to be in the low double digits. Estimates vary but we believe approximately half of patients with HCM have oHCM, in which the thickening of the cardiac muscle leads to LVOT obstruction, while the remaining HCM patients have nHCM, in which blood flow is not impacted, but the heart muscle is still thickened. HCM is fairly evenly split across gender and while patients are typically diagnosed in their early 40s, the average age of an oHCM patient is in the early 60s. People with HCM are at high risk of also developing cardiovascular complications, including atrial fibrillation, stroke and mitral valve disease. People with HCM are at risk for potentially fatal ventricular arrhythmias, and HCM is one of the leading causes of sudden cardiac death in younger people or athletes. A subset of patients with HCM are at high risk of progressive disease leading to dilated cardiomyopathy and heart failure necessitating cardiac transplantation.
In December 2025, the FDA approved MYQORZO, 5 mg, 10 mg, 15 mg, and 20 mg tablets for the treatment of adults with symptomatic oHCM to improve functional capacity and symptoms. MYQORZO is an allosteric and reversible inhibitor of cardiac myosin motor activity. The approval of MYQORZO included a risk evaluation and mitigation strategy (REMS) program intended to support a favorable benefit-risk profile in light of the risk of heart failure due to systolic dysfunction. In addition, in February 2026, the European Commission approved MYQORZO® (aficamten), 5 mg, 10 mg, 15 mg and 20 mg tablets for the treatment of symptomatic (New York Heart Association, NYHA, class II-III) obstructive hypertrophic cardiomyopathy (oHCM) in adult patients. Moreover, in December 2025, the China National Medical Products Administration approved MYQORZO for the treatment of adults with (New York Heart Association class II-III) oHCM, to improve exercise capacity and symptoms.
We commenced commercial sales of MYQORZO in the United States in the first quarter of 2026. Our market research supports our belief that MYQORZO will be highly competitive amongst cardiac myosin inhibitors, potentially eventually achieving a greater than 50% market share in the United States but also growing the cardiac myosin inhibitor category overall.
The commercial prospects for MYQORZO depend on three launch drivers: clinical evidence, our experience with HCPs and patients, and the approved label. Clinical evidence shows that treatment with MYQORZO in adult patients with symptomatic oHCM led to rapid and sustained reduction in obstruction and improvement in symptoms. Our experience with HCPs and patients informed our Cardiac Account Specialist (CAS) design, including its single point of contact and accountability for HCP's with our field sales organization and our bespoke patient support program, MYQORZO and You.
We believe the MYQORZO prescribing information allows for flexibility to titrate as early as two weeks, with echo assessment within 2 to 8 weeks following dose initiation and any subsequent dose changes, and importantly, a patient's dose may be titrated as needed after each echo with no delay.
In the European Union, we commenced commercialization activities in Germany in the second quarter of 2026 to be followed by other major European countries. In July 2026, the Medicines and Healthcare products Regulatory Agency (MHRA) granted MYQORZO marketing authorization across the United Kingdom for the treatment of symptomatic oHCM in adult patients. We expect the UK product launch later this year. MYQORZO is also approved in China for the treatment of adults with (New York Heart Association class II-III) oHCM, to improve exercise capacity and symptoms. Sanofi has the commercial rights for China and Taiwan and commenced commercialization of MYQORZO in the first quarter of 2026.
Finally, in January 2026 we submitted, and the FDA subsequently accepted for filing, a supplemental NDA for MYQORZO to the FDA requesting to include the results of MAPLE-HCM, a Phase 3 randomized, double blind, active-comparator clinical trial of aficamten as monotherapy compared to metoprolol as a monotherapy in patients with obstructive HCM, in the label. The FDA assigned a standard review classification to the sNDA with a PDUFA date of November 14, 2026.
Research and Development Programs
Our research and development activities related to muscle contractility include our cardiac muscle contractility programs and our skeletal muscle contractility programs. We also conduct research and development on novel treatments for disorders involving muscle function beyond muscle contractility.
We are leveraging our current understandings of muscle biology to investigate new ways of modulating other aspects of muscle function for other potential therapeutic applications.
Specialty Cardiology Programs
Our specialty cardiology program is focused on the cardiac sarcomere, the basic unit of muscle contraction in the heart. The cardiac sarcomere is a highly ordered cytoskeletal structure composed of cardiac myosin, actin and a set of regulatory proteins. Cardiac myosin is the cytoskeletal motor protein in the cardiac muscle cell. It is directly responsible for converting chemical energy into the mechanical force, resulting in cardiac muscle contraction. Our most advanced cardiac program, MYQORZO (aficamten), is based on the hypothesis that inhibitors of cardiac myosin may attenuate the hyperdynamic contraction resulting from pathologic mutations in the sarcomere that lead to hypertrophic cardiomyopathies. MYQORZO was approved in the U.S., Europe and China for the treatment of adults with symptomatic oHCM. We submitted a supplemental NDA to the FDA in January 2026 with the intent to include the results of MAPLE-HCM (a Phase 3 randomized, double blind, active-comparator clinical trial of aficamten as monotherapy compared to metoprolol as a monotherapy in patients with obstructive HCM) in the label. Finally, as described below, we evaluated aficamten for the potential treatment of adults with symptomatic nHCM in ACACIA-HCM.
In addition, omecamtiv mecarbil is our late-stage clinical program directed to the hypothesis that activators of cardiac myosin may target the underlying deficit of cardiac contractility in heart failure with severely reduced ejection fraction and address certain adverse properties of existing positive inotropic agents. Omecamtiv mecarbil is a novel cardiac myosin activator that works by directly stimulating the activity of the cardiac myosin motor protein, without increasing the intracellular calcium concentration. This drug candidate accelerates the rate-limiting step of the myosin enzymatic cycle and shifts it in favor of the force-producing state. Rather than increasing the velocity of cardiac contraction, this mechanism lengthens the systolic ejection time, which results in increased cardiac function in a potentially more oxygen-efficient manner.
Aficamten
Aficamten is a novel, oral, small molecule cardiac myosin inhibitor that our scientists discovered for the treatment of HCM. Aficamten arose from an extensive chemical optimization program conducted with attention to therapeutic index and pharmacokinetic properties. Aficamten was designed to reduce the hypercontractility associated with HCM. In preclinical models, aficamten reduces myocardial contractility by binding directly to cardiac myosin at a distinct and selective allosteric binding site, thereby preventing myosin from entering a force producing state. Aficamten reduces the number of active actin-myosin cross bridges during each cardiac cycle and consequently reduces myocardial contractility. This mechanism of action may be therapeutically effective in conditions characterized by excessive hypercontractility, such as HCM. The preclinical pharmacokinetics of aficamten were characterized, evaluated and optimized for potential rapid onset, ease of titration and rapid symptom relief.
The development program for aficamten has assessed its potential as a treatment to improve exercise capacity and relieve symptoms in patients with oHCM. In addition, development work is ongoing to assess aficamten for its potential long-term effects on cardiac structure and function.
SEQUOIA-HCM
Aficamten was evaluated in SEQUOIA-HCM, a positive pivotal Phase 3 clinical trial in patients with symptomatic oHCM. The results from SEQUOIA-HCM showed that treatment with aficamten for 24 weeks significantly improved exercise capacity compared to placebo. Statistically significant and clinically meaningful improvements were also observed in all 10 prespecified secondary endpoints, with functional and symptomatic improvements occurring within two weeks of initiating treatment with aficamten and sustained throughout the treatment period. The safety of aficamten was consistent with previous trials.
MAPLE-HCM
Aficamten was also evaluated in MAPLE-HCM, a Phase 3 randomized, double blind, active-comparator clinical trial of aficamten as monotherapy compared to metoprolol as a monotherapy in patients with obstructive HCM which demonstrated a statistically significant improvement in peak oxygen uptake (pVO2) from baseline to Week 24 for aficamten compared to metoprolol. The safety of aficamten was consistent with previous trials.
ACACIA-HCM
Aficamten was also evaluated in ACACIA-HCM, a Phase 3 randomized, double blind clinical trial in patients with symptomatic nHCM. ACACIA-HCM met both dual primary endpoints, demonstrating statistically significant improvements from baseline to Week 36 compared to placebo in both Kansas City Cardiomyopathy Questionnaire Clinical Summary Score (KCCQ) and maximal exercise performance (pVO2). The improvement in KCCQ was robust and consistent throughout the treatment period in participants on aficamten. Following washout, KCCQ decreased for participants on aficamten to match the placebo group. At Week 36, pVO2 increased for participants on aficamten, while it remained unchanged for participants on placebo, consistent with prior trials of aficamten in oHCM. Statistically significant (p<0.001) improvements compared to placebo were observed in key secondary endpoints including the proportion of participants with improvements in NYHA Functional Class, the composite z-score of ventilatory efficiency and pVO2, and NT-proBNP. There were no new safety signals identified. Left ventricular ejection fraction (LVEF) <50% occurred in 27 (10%) participants taking aficamten and 1% in participants taking placebo. Two participants on aficamten experienced a serious adverse event of heart failure associated with LVEF <50%. Treatment interruptions due to LVEF <40% occurred in 3% of participants taking aficamten.
Aficamten continues to be evaluated in CEDAR-HCM, a clinical trial of aficamten in a pediatric population with oHCM; and FOREST-HCM, an open-label extension clinical study of aficamten in patients with HCM. We expect to complete enrollment in the adolescent cohort of CEDAR-HCM in the third quarter of 2026.
Omecamtiv mecarbil
We are developing omecamtiv mecarbil as a potential treatment across the continuum of care in heart failure with severely reduced ejection fraction both for use in the hospital setting and for use in the outpatient setting.
Omecamtiv mecarbil is a selective, small molecule cardiac myosin activator, the first of a novel class of myotropes designed to directly target the contractile mechanisms of the heart, binding to and recruiting more cardiac myosin heads to interact with actin during systole. Omecamtiv mecarbil is designed to increase the number of active actin-myosin cross bridges during each cardiac cycle and consequently augment the impaired contractility that is associated with heart failure with reduced ejection fraction, or HFrEF.
GALACTIC-HF
GALACTIC-HF is a Phase 3 cardiovascular outcomes clinical trial of omecamtiv mecarbil that was conducted by Amgen in collaboration with Cytokinetics. The primary objective of this double-blind, randomized, placebo-controlled multicenter clinical trial was to determine if treatment with omecamtiv mecarbil when added to standard of care is superior to standard of care plus placebo in reducing the risk of cardiovascular death or heart failure events in patients with high-risk chronic heart failure and reduced ejection fraction.
The results of GALACTIC-HF showed a statistically significant effect of treatment with omecamtiv mecarbil to reduce risk of the primary composite endpoint of CV death or heart failure events (heart failure hospitalization and other urgent treatment for heart failure) compared to placebo in patients treated with standard of care after a median duration of follow up of 21.8 months.
COMET-HF
Based on supplemental and subgroup analyses suggesting that certain biologically plausible subgroups of patients treated with omecamtiv mecarbil in GALACTIC-HF may have benefited more than the general patient population in the trial due to the high unmet need in patients with heart failure with severely reduced ejection fraction, we are continuing the development program for omecamtiv mecarbil. In the fourth quarter of 2024, we commenced patient enrollment in COMET-HF (Confirmation of Omecamtiv Mecarbil Efficacy Trial in Heart Failure), a Phase 3 multi-center, double-blind, randomized, placebo-controlled trial to assess the efficacy and safety of omecamtiv mecarbil in patients with symptomatic HFrEF with severely reduced ejection fraction. The primary endpoint of COMET-HF is the time to first event in the primary composite endpoint of cardiovascular death, first heart failure event, LVAD implantation or cardiac transplantation, or stroke. COMET-HF is expected to enroll approximately 1,800 patients randomized on a 1:1 basis to receive omecamtiv mecarbil or placebo for up to 48 weeks.
Ulacamten (f/k/a CK-586)
Ulacamten is a novel, selective, oral, small molecule cardiac myosin inhibitor designed to reduce the hypercontractility associated with heart failure with preserved ejection fraction, or HFpEF. Approximately half of the estimated 6.7 million patients in the United States with heart failure have HFpEF, and the prevalence of HFpEF is increasing. A subset of HFpEF patients with hypercontractility, ventricular hypertrophy, elevated biomarkers and symptoms of heart failure may benefit from treatment with a cardiac sarcomere inhibitor. Approximately 75% of patients with HFpEF die within five years of initial hospitalization, and 84% are re-hospitalized. Despite broad use of standard treatments and advances in care, the prognosis for patients with heart failure is poor.
AMBER-HFpEF
In the fourth quarter of 2024, we announced the design of AMBER-HFpEF (Assessment of Ulacamten in a Multi-Center, Blinded Evaluation of Safety and Tolerability Results in HFpEF), a Phase 2 randomized, placebo-controlled, double-blind, multi-center, dose-finding clinical trial in patients with symptomatic HFpEF with left ventricular ejection fraction ≥ 60%. The primary objective is to evaluate the safety and tolerability profile of ulacamten compared to placebo. The secondary objectives include assessing the effect of ulacamten on LVEF and NT-proBNP, its pharmacokinetics, and its pharmacokinetic/pharmacodynamic relationship. AMBER-HFpEF is currently enrolling patients, and we expect to complete enrollment in cohort 2 of the study by the end of 2026.
Neuromuscular Program
Our neuromuscular program is focused on the activation of the skeletal sarcomere, the basic unit of skeletal muscle contraction. The skeletal sarcomere is a highly ordered cytoskeletal structure composed of skeletal muscle myosin, actin, and a set of regulatory proteins, which include the troponins and tropomyosin. This program leverages our expertise developed in our ongoing discovery and development of cardiac sarcomere activator.
In the fourth quarter of 2024, we announced that the first participants have been dosed in a Phase 1 randomized, double-blind, placebo-controlled, multi-part, single and multiple ascending dose clinical study of CK-089 in healthy human participants. CK-089 is a fast skeletal muscle troponin activator with potential therapeutic application to a specific type of muscular dystrophy and other conditions of impaired muscle function. The primary objective of this Phase 1 randomized, double-blind, placebo-controlled, multi-part single and multiple ascending dose clinical study is to evaluate the safety, tolerability and pharmacokinetics of CK-089 when administered orally as single or multiple doses to healthy participants. The study design includes single ascending dose cohorts and multiple-dose ascending cohorts comprised of 10 participants each. Our clinical development program for CK-089 was subject to a partial clinical hold from FDA that limited our ability to dose patients at doses anticipated to result in plasma exposures higher than certain levels. FDA subsequently lifted the partial clinical trial hold in the second quarter of 2026, permitting us to continue our development program as intended.
Results of Operations
Revenues
Our revenues since inception were primarily from our collaboration partners. We did not generate any revenue from commercial product sales prior to the year ended December 31, 2025. MYQORZO for adults with symptomatic oHCM was approved by the FDA in December 2025 and our first commercial sale of MYQORZO occurred in the first quarter of 2026.
Revenues for the three and six months ended June 30, 2026 and 2025, were as follows (in thousands):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended |
|
|
|
|
|
Six Months Ended |
|
|
|
|
|
|
June 30, 2026 |
|
|
June 30, 2025 |
|
|
Decrease |
|
|
June 30, 2026 |
|
|
June 30, 2025 |
|
|
Decrease |
|
Net product revenue |
|
$ |
25,334 |
|
|
$ |
— |
|
|
$ |
25,334 |
|
|
$ |
30,123 |
|
|
$ |
— |
|
|
$ |
30,123 |
|
Collaboration revenues |
|
|
3,290 |
|
|
|
2,416 |
|
|
|
874 |
|
|
|
5,927 |
|
|
|
3,995 |
|
|
|
1,932 |
|
License and milestone revenues |
|
|
— |
|
|
|
64,353 |
|
|
|
(64,353 |
) |
|
|
11,929 |
|
|
|
64,353 |
|
|
|
(52,424 |
) |
Total revenues |
|
$ |
28,624 |
|
|
$ |
66,769 |
|
|
$ |
(38,145 |
) |
|
$ |
47,979 |
|
|
$ |
68,348 |
|
|
$ |
(20,369 |
) |
Net product revenue was recorded for our commercial sales of MYQORZO commencing in the last week of January 2026, for the three and six months ended June 30, 2026.
Net product revenue by geographic area for the three and six months ended June 30, 2026 and 2025, were as follows (in thousands):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended |
|
|
Six Months Ended |
|
|
|
June 30, 2026 |
|
|
June 30, 2025 |
|
|
June 30, 2026 |
|
|
June 30, 2025 |
|
United States |
|
$ |
22,964 |
|
|
$ |
— |
|
|
$ |
27,753 |
|
|
$ |
— |
|
Europe |
|
|
2,370 |
|
|
|
— |
|
|
|
2,370 |
|
|
|
— |
|
Total net product revenue |
|
$ |
25,334 |
|
|
$ |
— |
|
|
$ |
30,123 |
|
|
$ |
— |
|
Collaboration revenues for the three and six months ended June 30, 2026 and 2025 were primarily from Bayer under the Bayer License Agreement related to certain research and development cost reimbursements.
License and milestone revenues for the three and six months ended June 30, 2026 were from Bayer related to the first commercial sale of MYQORZO in the United States. License and milestone revenues for the three and six months ended June 30, 2025 were primarily from Bayer related to the delivery of the license and completion of the technology transfer totaling $52.4 million and certain clinical milestone achievements totaling $11.8 million.
As of June 30, 2026, the accounts receivable, net balance was $24.4 million comprised of $2.5 million related to Bayer and $0.4 million related to Sanofi. The remaining $21.5 million receivable is associated with product revenue.
Operating expenses
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended |
|
|
|
|
|
Six Months Ended |
|
|
|
|
|
|
June 30, 2026 |
|
|
June 30, 2025 |
|
|
Increase |
|
|
June 30, 2026 |
|
|
June 30, 2025 |
|
|
Increase |
|
Research and development |
|
$ |
97,807 |
|
|
$ |
110,138 |
|
|
$ |
(12,331 |
) |
|
$ |
193,332 |
|
|
$ |
208,400 |
|
|
$ |
(15,068 |
) |
Selling, general and administrative |
|
|
104,397 |
|
|
|
65,721 |
|
|
|
38,676 |
|
|
|
209,293 |
|
|
|
123,090 |
|
|
|
86,203 |
|
Cost of goods sold |
|
|
2,731 |
|
|
|
— |
|
|
|
2,731 |
|
|
|
2,891 |
|
|
|
— |
|
|
|
2,891 |
|
Collaboration cost of revenues (a) |
|
|
2,861 |
|
|
|
2,416 |
|
|
|
445 |
|
|
|
5,253 |
|
|
|
3,995 |
|
|
|
1,258 |
|
Total operating expenses |
|
$ |
207,796 |
|
|
$ |
178,275 |
|
|
$ |
29,521 |
|
|
$ |
410,769 |
|
|
$ |
335,485 |
|
|
$ |
75,284 |
|
(a) Includes costs incurred in connection with manufacturing drug supplies for collaboration partners.
Operating expenses included stock-based compensation expense of $35.7 million and $27.5 million for the three months ended June 30, 2026 and 2025, respectively, and $66.1 million and $51.1 million for the six months ended June 30, 2026 and 2025, respectively.
Research and development expenses
We incur research and development expenses that consist of employee compensation, supplies and materials, costs for consultants, contract research, clinical manufacturing and facilities and depreciation costs.
Research and development expenses for the three and six months ended June 30, 2026 and 2025, were as follows (in thousands):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended |
|
|
|
|
|
Six Months Ended |
|
|
|
|
|
|
June 30, 2026 |
|
|
June 30, 2025 |
|
|
Decrease |
|
|
June 30, 2026 |
|
|
June 30, 2025 |
|
|
Decrease |
|
External costs: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Aficamten |
|
$ |
14,853 |
|
|
$ |
27,490 |
|
|
$ |
(12,637 |
) |
|
$ |
35,960 |
|
|
$ |
55,758 |
|
|
$ |
(19,798 |
) |
Omecamtiv Mecarbil |
|
|
8,843 |
|
|
|
3,967 |
|
|
|
4,876 |
|
|
|
14,396 |
|
|
|
7,564 |
|
|
|
6,832 |
|
Other programs |
|
|
5,250 |
|
|
|
3,025 |
|
|
|
2,225 |
|
|
|
8,403 |
|
|
|
6,398 |
|
|
|
2,005 |
|
Unallocated |
|
|
10,804 |
|
|
|
21,213 |
|
|
|
(10,409 |
) |
|
|
17,530 |
|
|
|
29,553 |
|
|
|
(12,023 |
) |
Total external costs |
|
|
39,750 |
|
|
|
55,695 |
|
|
|
(15,945 |
) |
|
|
76,289 |
|
|
|
99,273 |
|
|
|
(22,984 |
) |
Internal costs: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Employee related |
|
|
45,267 |
|
|
|
40,593 |
|
|
|
4,674 |
|
|
|
90,799 |
|
|
|
80,320 |
|
|
|
10,479 |
|
Facilities, lab supplies and other |
|
|
12,790 |
|
|
|
13,850 |
|
|
|
(1,060 |
) |
|
|
26,244 |
|
|
|
28,807 |
|
|
|
(2,563 |
) |
Total internal costs |
|
|
58,057 |
|
|
|
54,443 |
|
|
|
3,614 |
|
|
|
117,043 |
|
|
|
109,127 |
|
|
|
7,916 |
|
Total research and development expenses |
|
$ |
97,807 |
|
|
$ |
110,138 |
|
|
$ |
(12,331 |
) |
|
$ |
193,332 |
|
|
$ |
208,400 |
|
|
$ |
(15,068 |
) |
Research and development expenses for the three months ended June 30, 2026 decreased by $12.3 million compared to the three months ended June 30, 2025. The decrease was primarily due to higher clinical trial activity, supply chain costs and medical affairs activities in 2025 partially offset by higher personnel-related costs in 2026.
Research and development expenses for the six months ended June 30, 2026 decreased by $15.1 million compared to the six months ended June 30, 2025. The decrease was primarily due to higher clinical trial activity, supply chain costs and medical fairs activities in 2025 partially offset by higher personnel-related costs in 2026.
Our development program for aficamten continues with CEDAR-HCM, our placebo-controlled and open-label extension clinical trial to evaluate the efficacy, pharmacokinetics (PK) and safety of aficamten in a pediatric population with symptomatic oHCM. Additionally, we have FOREST-HCM which is an open label extension study designed to assess the long-term safety and tolerability of aficamten in patients with HCM.
We continue to develop omecamtiv mecarbil in COMET-HF, a Phase 3 clinical trial of omecamtiv mecarbil in patients with symptomatic HFrEF with severely reduced ejection fraction. The intention of the $100 million RP OM Loan Agreement was to partially cover the costs of COMET-HF.
We continue to develop ulacamten in AMBER-HFpEF, a Phase 2 clinical trial of ulacamten in patients with symptomatic HFpEF, in which patient enrollment commenced in the first quarter of 2025. The $50 million in proceeds from the RP Ulacamten RPA are intended to offset expenses related to the conduct of AMBER-HFpEF. If the results of AMBER-HFpEF are supportive of continuing the development of ulacamten and commencing a Phase 3 clinical trial, Royalty Pharma has the option to fund potentially 50% of the continued development of ulacamten up to $150 million, subject to Royalty Pharma’s opt-in right to acquire an additional 3.5% revenue interest in our or our licensee’s future worldwide net sales of drug products containing ulacamten.
In the fourth quarter of 2024, we announced that the first participants have been dosed in a Phase 1 randomized, double-blind, placebo-controlled, multi-part, single and multiple ascending dose clinical study of CK-089 in healthy human participants. CK-089 is a fast skeletal muscle troponin activator with potential therapeutic application to a specific type of muscular dystrophy and other conditions of impaired muscle function. The primary objective of this Phase 1 randomized, double-blind, placebo-controlled, multi-part single and multiple ascending dose clinical study is to evaluate the safety, tolerability and pharmacokinetics of CK-089 when administered orally as single or multiple doses to healthy participants. The study design includes single ascending dose cohorts and multiple-dose ascending cohorts comprised of 10 participants each. Our clinical development program for CK-089 was subject to a partial clinical hold from FDA. FDA subsequently lifted the partial clinical trial hold in the second quarter of 2026, permitting us to continue our development program as intended.
We expect that research and development expenses will be flat to declining in 2026 relative to 2025 due to the completion of MAPLE-HCM and ACACIA-HCM, partially offset by the continuation of COMET-HF, AMBER HFpEF, CEDAR-HCM, FOREST-HCM and any additional clinical trials we may choose to undertake in connection with CK-089 or any other drug candidates.
Selling, general and administrative expenses
Selling, general and administrative expenses consist primarily of personnel costs, facilities and overhead costs, and selling, marketing and advertising expenses, as well as other general and administrative costs related to finance, human resources, legal and other administrative activities.
Selling, general and administrative expenses for the three and six months ended June 30, 2026 and 2025, were as follows (in thousands):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended |
|
|
|
|
|
Six Months Ended |
|
|
|
|
|
|
June 30, 2026 |
|
|
June 30, 2025 |
|
|
Increase |
|
|
June 30, 2026 |
|
|
June 30, 2025 |
|
|
Increase |
|
Total selling, general and administrative expenses |
|
$ |
104,397 |
|
|
$ |
65,721 |
|
|
$ |
38,676 |
|
|
$ |
209,293 |
|
|
$ |
123,090 |
|
|
$ |
86,203 |
|
Selling, general and administrative expenses for the three months ended June 30, 2026 increased by $38.7 million from the three months ended June 30, 2025, primarily due to external costs associated with the commercial launch of MYQORZO and higher personnel related costs, including stock-based compensation.
Selling, general and administrative expenses for the six months ended June 30, 2026 increased by $86.2 million from the six months ended June 30, 2025, primarily due to external costs associated with the commercial launch of MYQORZO and higher personnel related costs, including stock-based compensation.
We expect selling, general and administrative expenses to increase significantly in 2026. With the approval of MYQORZO in the United States, we expect to incur additional expenses for commercial activities, including, but not limited to, the full year impact of the U.S. sales force, training and education, the implementation of compliance systems, patient support programs, sales and marketing expenses and pre-commercial activities to to support the commercial launch of MYQORZO in nHCM. In addition, the European Commission approved MYQORZO for the treatment of adults with symptomatic oHCM, (NYHA class II-III), and therefore, we expect to incur similar expenses for commercial readiness activities in Europe but with additional expenses for the establishment of a corporate infrastructure to enable commercialization activities in key European markets, beginning in Germany with other major European markets to follow.
Cost of Goods Sold
Costs of goods sold for the three and six months ended June 30, 2026 and 2025, were as follows (in thousands):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended |
|
|
|
|
|
Six Months Ended |
|
|
|
|
|
|
June 30, 2026 |
|
|
June 30, 2025 |
|
|
Increase |
|
|
June 30, 2026 |
|
|
June 30, 2025 |
|
|
Increase |
|
Total cost of goods sold |
|
$ |
2,731 |
|
|
$ |
— |
|
|
$ |
2,731 |
|
|
$ |
2,891 |
|
|
$ |
— |
|
|
$ |
2,891 |
|
We received FDA approval for MYQORZO on December 19, 2025 and began capitalizing inventories upon FDA approval. Costs incurred prior to approval were recorded as research and development expense in our condensed consolidated statement of operations and comprehensive loss. As a result, cost of goods sold for the next several quarters are expected to reflect a lower average per unit cost of materials. Cost of goods sold in the second quarter of 2026 reflects a charge related to drug supply optimization which accounts for nearly the entire amount.
Collaboration Cost of Revenues
Collaboration cost of revenues includes cost reimbursements as well as costs incurred in connection with manufacturing drug supplies for collaboration partners. Collaboration of cost of revenues for the three and six months ended June 30, 2026 and 2025, were as follows (in thousands):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended |
|
|
|
|
|
Six Months Ended |
|
|
|
|
|
|
June 30, 2026 |
|
|
June 30, 2025 |
|
|
Increase |
|
|
June 30, 2026 |
|
|
June 30, 2025 |
|
|
Increase |
|
Total collaboration cost of revenues |
|
$ |
2,861 |
|
|
$ |
2,416 |
|
|
$ |
445 |
|
|
$ |
5,253 |
|
|
$ |
3,995 |
|
|
$ |
1,258 |
|
Collaboration cost of revenues for the three and six months ended June 30, 2026 and 2025 were primarily from Bayer under the Bayer License Agreement related to certain research and development cost reimbursements.
Interest Expense
Interest expense for the three and six months ended June 30, 2026 and 2025, was as follows (in thousands):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended |
|
|
|
|
|
Six Months Ended |
|
|
|
|
|
|
June 30, 2026 |
|
|
June 30, 2025 |
|
|
Increase |
|
|
June 30, 2026 |
|
|
June 30, 2025 |
|
|
Increase |
|
Term loans |
|
$ |
8,914 |
|
|
$ |
5,252 |
|
|
$ |
3,662 |
|
|
$ |
17,659 |
|
|
$ |
8,370 |
|
|
$ |
9,289 |
|
2026 Notes |
|
|
117 |
|
|
|
240 |
|
|
|
(123 |
) |
|
|
355 |
|
|
|
477 |
|
|
|
(122 |
) |
2027 Notes |
|
|
1,452 |
|
|
|
5,542 |
|
|
|
(4,090 |
) |
|
|
2,886 |
|
|
|
11,014 |
|
|
|
(8,128 |
) |
2031 Notes |
|
|
4,075 |
|
|
|
— |
|
|
|
4,075 |
|
|
|
8,102 |
|
|
|
— |
|
|
|
8,102 |
|
Other |
|
|
96 |
|
|
|
50 |
|
|
|
46 |
|
|
|
171 |
|
|
|
91 |
|
|
|
80 |
|
Total interest expense |
|
$ |
14,654 |
|
|
$ |
11,084 |
|
|
$ |
3,570 |
|
|
$ |
29,173 |
|
|
$ |
19,952 |
|
|
$ |
9,221 |
|
Term loan interest expense is related to the RP Multi Tranche Loan and increased year over year due to four tranches of interest expense being incurred in first quarter of 2026 for Tranches 1, 4, 5 and 6 compared to two tranches in the first quarter of 2025 related to Tranche 1 and 6. In September 2025, we issued the 2031 Notes and used the net proceeds and common stock to partially repurchase the 2027 Notes. Due to the balance of the 2027 Notes declining in the third quarter of 2025, interest expense declined year over year. There will be no additional interest on the 2026 Notes subsequent to June 30, 2026 since they have been fully redeemed.
Interest expense in 2026 is expected to increase further because of the $100 million drawn in October 2025 for Tranche 5 which will be outstanding for the entirety of 2026. Interest expense may increase further if we draw on Tranche 7.
Non-cash interest expense on liabilities related to revenue participation right purchase agreements
Non-cash interest expense results from the accretion of our liabilities to RPFT and RP ICAV related to the sale of future royalties under the RP OM RPA and the RP Aficamten RPA, respectively.
Non-cash interest expense on liability related to the RP OM RPA and the RP Aficamten RPA for the three and six months ended June 30, 2026 and 2025 were as follows (in thousands):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended |
|
|
|
|
|
Six Months Ended |
|
|
|
|
|
|
June 30, 2026 |
|
|
June 30, 2025 |
|
|
Increase |
|
|
June 30, 2026 |
|
|
June 30, 2025 |
|
|
Increase |
|
RP OM Liability |
|
$ |
— |
|
|
$ |
41 |
|
|
$ |
(41 |
) |
|
$ |
— |
|
|
$ |
82 |
|
|
$ |
(82 |
) |
RP Aficamten Liability |
|
|
20,177 |
|
|
|
13,140 |
|
|
|
7,037 |
|
|
|
38,993 |
|
|
|
27,177 |
|
|
|
11,816 |
|
Total non-cash interest expense recognized |
|
$ |
20,177 |
|
|
$ |
13,181 |
|
|
$ |
6,996 |
|
|
$ |
38,993 |
|
|
$ |
27,259 |
|
|
$ |
11,734 |
|
The carrying amount of the RP Aficamten Liability is based on our estimate of the future royalties to be paid pursuant to RP Aficamten RPA over the life of the arrangement as discounted using an imputed rate of interest. The imputed rate of interest on the carrying value of the RP Aficamten Liability was approximately 26.1% as of June 30, 2026 and 20.5% as of June 30, 2025.
The carrying amount of the RP OM Liability is based on our estimate of the future royalties to be paid pursuant to RP OM RPA over the life of the arrangement as discounted using an imputed rate of interest. The excess of future estimated royalty payments over the $92.3 million of allocated proceeds, less issuance costs, is recognized as non-cash interest expense using the effective interest method. The imputed rate of interest on the carrying value of the RP OM Liability is reassessed periodically and is not reduced below 0%. The imputed rate of interest on the carrying value of the RP OM Liability was 0.0% as of June 30, 2026 and approximately 0.1% as of June 30, 2025.
We review our assumptions on a regular basis and our estimates may change in the future as we refine and reassess our assumptions.
Interest and Other Income, net
Interest and other income, net for the three and six months ended June 30, 2026 and 2025 consisted primarily of interest income generated from our cash, cash equivalents and investments.
Change in fair value liabilities related to RPI transactions and derivative liabilities reflected on the Condensed Consolidated Statement of Operations.
The change in fair value liabilities related to the RPI transactions (RP OM Loan Agreement and RP Ulacamten RPA) and the derivative liabilities for the RP Multi Tranche Loan Agreement for the three and six months ended June 30, 2026 and 2025 were as follows (in thousands):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended |
|
|
|
|
|
Six Months Ended |
|
|
|
|
|
|
June 30, 2026 |
|
|
June 30, 2025 |
|
|
Increase |
|
|
June 30, 2026 |
|
|
June 30, 2025 |
|
|
Increase |
|
RP Ulacamten RPA |
|
$ |
300 |
|
|
$ |
(300 |
) |
|
$ |
600 |
|
|
$ |
500 |
|
|
$ |
— |
|
|
$ |
500 |
|
RP OM Loan |
|
|
2,100 |
|
|
|
(14,300 |
) |
|
|
16,400 |
|
|
|
300 |
|
|
|
(10,700 |
) |
|
|
11,000 |
|
RP Multi Tranche Loan Agreement Derivatives |
|
|
(1,100 |
) |
|
|
3,000 |
|
|
|
(4,100 |
) |
|
|
400 |
|
|
|
2,600 |
|
|
|
(2,200 |
) |
Total change in fair value liabilities |
|
$ |
1,300 |
|
|
$ |
(11,600 |
) |
|
$ |
12,900 |
|
|
$ |
1,200 |
|
|
$ |
(8,100 |
) |
|
$ |
9,300 |
|
The fair values of the liabilities related to RPI transactions (RP OM Loan Agreement and RP Ulacamten RPA) are based on significant unobservable inputs, including the probability of clinical success and regulatory approval based on historical industry success rates for product development specific to cardiovascular products, the estimated date of a product launch, estimates of pricing, sales ramp, variables for the timing of the related events, probability of change of control, and discount rates (which ranged from 14% to 17% and 12% to 17% for the three and six months ended June 30, 2026, respectively, and 10% to 18% for the three and six months ended June 30, 2025), which are deemed to be Level 3 inputs in the fair value hierarchy. As products containing omecamtiv mecarbil and ulacamten have not yet been commercialized, the estimates are highly subjective. For example, assumed increases in the probability of the clinical success for the programs for omecamtiv mecarbil or ulacamten could increase the value of the liabilities. Similarly, assumed decreases in the discount rates used in the fair value measurements could also increase the value of the liabilities at period end.
The fair values of the derivative liabilities are determined using the probability-weighted expected return method and the “with and without” method. The fair values are based on significant unobservable inputs, including the probability of change of control, the probability of default (less than 10%), discount rates (ranging from 14% to 15% and 12% to 15% for the three and six months ended June 30, 2026, respectively, and 10% to 12% and 10% to 14% for the three and six months ended June 30, 2025, respectively) and other factors.
The total change in the estimated fair value liabilities for the three and six months ended June 30, 2026 was primarily driven by changes in the discount rates used in the valuation of the 2024 RP OM Loan and the derivatives associated with the RP Multi Tranche Loan Agreement.
Liquidity and Capital Resources
Our cash, cash equivalents, and investments and a summary of our borrowings and working capital as of June 30, 2026 and December 31, 2025 are summarized as follows (in thousands):
|
|
|
|
|
|
|
|
|
|
|
June 30, 2026 |
|
|
December 31, 2025 |
|
Financial assets: |
|
|
|
|
|
|
Cash and cash equivalents |
|
$ |
255,271 |
|
|
$ |
122,518 |
|
Short-term investments |
|
|
910,415 |
|
|
|
759,703 |
|
Long-term investments |
|
|
538,317 |
|
|
|
335,048 |
|
Total cash, cash equivalents, and marketable securities |
|
$ |
1,704,003 |
|
|
$ |
1,217,269 |
|
Borrowings: |
|
|
|
|
|
|
Term loans (including related derivative liabilities measured at fair value) |
|
$ |
306,260 |
|
|
$ |
297,644 |
|
Convertible notes, net |
|
|
871,527 |
|
|
|
890,618 |
|
Liabilities related to RPI transactions measured at fair value |
|
|
136,400 |
|
|
|
137,200 |
|
Total borrowings |
|
$ |
1,314,187 |
|
|
$ |
1,325,462 |
|
Working capital: |
|
|
|
|
|
|
Current assets |
|
$ |
1,208,487 |
|
|
$ |
916,975 |
|
Current liabilities |
|
|
181,429 |
|
|
|
202,452 |
|
Working capital |
|
$ |
1,027,058 |
|
|
$ |
714,523 |
|
The following table shows a summary of our cash flows for the periods set forth below (in thousands):
|
|
|
|
|
|
|
|
|
|
|
Six Months Ended |
|
|
|
June 30, 2026 |
|
|
June 30, 2025 |
|
Net cash used in operating activities |
|
$ |
(305,297 |
) |
|
$ |
(259,853 |
) |
Net cash (used in) provided by investing activities |
|
|
(361,506 |
) |
|
|
158,837 |
|
Net cash provided by financing activities |
|
|
800,627 |
|
|
|
83,287 |
|
Total |
|
$ |
133,824 |
|
|
$ |
(17,729 |
) |
Sources and Uses of Cash
We funded our operations and capital expenditures with proceeds primarily from private and public sales of our equity securities, royalty monetization agreements, and revenue interest agreements, strategic alliances, long-term debt, other financings and interest on investments. We have generated significant operating losses since our inception. Our expenditures have historically been primarily related to research and development activities but have recently and will increasingly relate to our commercial readiness activities and general commercialization activities of our drug products. In December 2025, the FDA approved MYQORZO, 5 mg, 10 mg, 15 mg and 20 mg tablets for the treatment of adults with symptomatic oHCM to improve functional capacity and symptoms, with sales of MYQORZO commencing in the first quarter of 2026. Product was launched in Germany and China in the first half of 2026. Accordingly, we will be increasingly relying on revenues generated from commercial sales of MYQORZO and/or traditional financing activities to fund our operations and cash expenditures.
Cash Flows Used in Operating Activities
Net cash used in operating activities of $305.3 million and $259.9 million in the six months ended June 30, 2026 and 2025, respectively, was largely due to ongoing research and development activities and selling, general and administrative expenses to support commercial readiness and launch of MYQORZO. In future quarters fluctuations in accounts receivable and inventories will impact cash flows used in operating activities. Net loss for the six months ended June 30, 2026 and 2025 included, among other items: stock-based compensation, interest expense on liabilities related to revenue participation right purchase agreements and debt, and/or changes in fair values related to derivative liabilities and liabilities related to RPI Transactions.
Cash Flows Provided by Investing Activities
Net cash used in investing activities of $361.5 million in the six months ended June 30, 2026 was primarily due to maturities of investments offset by purchases of investments and property, plant and equipment.
Net cash provided by investing activities of $158.8 million in the six months ended June 30, 2025 was primarily due to purchases of investments and property, plant and equipment offset by maturities of investments.
Cash Flows Provided by Financing Activities
Net cash provided by financing activities of $800.6 million in the six months ended June 30, 2026 was primarily due to $760.1 million of net proceeds from a public offering in May 2026 in addition to net proceeds from stock-based award activities, offset by repayment of RP Multi Tranche Term Loan.
Net cash provided by financing activities of $83.3 million in the six months ended June 30, 2025 was primarily attributable to $75.0 million in proceeds from the drawing on Tranche 4 of the RP Multi Tranche Term Loan and net proceeds from stock-based award activities, offset by payments related to the RP Multi Tranche Term Loan.
2024 Royalty Pharma Transactions
In May 2024, we entered into a series of financing agreements with affiliates of Royalty Pharma, including the RP OM Loan Agreement, the RP Ulacamten RPA, the 2022 RP Multi Tranche Loan Agreement Amendment, the RP Aficamten RPA Amendment, and the RP Stock Purchase Agreement for a private placement of common stock concurrent with our underwritten public offering of common stock.
The RP OM Loan Agreement provides for a loan in the principal amount of $100.0 million that was drawn at the closing with no remaining amounts available for disbursement. The loan under the RP OM Loan Agreement matures on the 10 year anniversary of the funding date and is repayable in quarterly installments, the amounts of which will depend on the occurrence of certain events related to the results and timing of COMET-HF and potential regulatory approvals of omecamtiv mecarbil, as follows:
•Scenario 1: If the Phase 3 clinical trial of Cytokinetics’ proprietary small molecule cardiac myosin activator known as omecamtiv mecarbil is successful (defined as meeting the composite primary endpoint of the first event, whichever occurs first, comprising of cardiovascular death, heart failure event, LVAD implementation/cardiac transplantation, or stroke, with a hazard ratio (HR) of less than 0.85 and cardiovascular death endpoint HR of less than 1.0) by June 30, 2028 and we receive the marketing approval from the FDA for omecamtiv mecarbil on or prior to December 31, 2029 (“OM Approval Date”), commencing on the calendar quarter during which the FDA approval is obtained, we are required to pay RPDF (x) (i) $75.0 million ten business days after the OM Approval Date and (ii) $25.0 million on the first anniversary of the OM Approval Date and (y) on a quarterly basis an amount equal to 2.0% of the annual worldwide net sales of omecamtiv mecarbil, subject to a minimum floor amount ranging from $5.0 million to $8.0 million during the first 18 calendar quarters (the payment of the 2.0% of the annual worldwide net sales starting from the 19th calendar quarter shall be referred to as the “Royalty Payment”). Our obligation to pay the Royalty Payment will continue after maturity of the Loan;
•Scenario 2: If the Phase 3 clinical trial of omecamtiv mecarbil is successful by June 30, 2028 but we have not received the marketing approval from the FDA for omecamtiv mecarbil on or prior to December 31, 2029, we are required to pay RPDF 18 equal quarterly cash payments totaling 237.5% of the principal amount of the loan commencing on March 31, 2030; and
•Scenario 3: If the Phase 3 clinical trial of omecamtiv mecarbil is not successful by June 30, 2028, we are required to pay RPDF 22 equal quarterly cash payments totaling 227.5% of the principal amount of the loan commencing on September 30, 2028.
The interest on this loan is included in the scheduled payment amount for each scenario.
Pursuant to the RP Ulacamten RPA, RPI ICAV purchased rights to up to 4.5% of worldwide net sales of drug products containing ulacamten by us, our affiliates or licensees, in exchange for up to $200 million in consideration, $50 million of which was paid upfront and, following the initiation of the first Phase 3 clinical trial (or the Phase 3 portion of the first Phase 2b/3 clinical trial) in HFpEF for ulacamten, at RPI ICAV’s sole discretion, up to in aggregate $150 million to fund 50.0% of the research and development cost of ulacamten. The initial $50 million paid to us entitles RPI ICAV to 1% of worldwide net sales of drug products containing ulacamten by us, our affiliates, or licenses. We will not know for certain whether any additional funding under the RP Ulacamten RPA may be available to us until the conclusion of AMBER-HFpEF, the results of the trial are known, and RPI ICAV has decided to exercise its option to purchase an incremental 3.5% revenue interest on our future annual worldwide net sales of drug products containing ulacamten or not.
2022 Royalty Pharma Transactions
In January 2022, we entered into a series of financing agreements with affiliates of Royalty Pharma, including the RP Multi Tranche Loan Agreement, and the RP Aficamten RPA.
Under the RP Multi Tranche Loan Agreement, we have drawn $275 million as of June 30, 2026. The remaining $175 million tranche 7 loan is also available to us now that the conditions for reimbursement, namely approval of our NDA for aficamten in patients with oHCM on or prior to December 31, 2025, have been met. We expect to draw Tranche 7 unless we are able to meet our financing requirements through more favorable funding sources.
Each term loan under the RP Multi Tranche Loan Agreement matures on the 10 year anniversary of the funding date for such term loan and is repayable in quarterly installments of principal, interest and fees commencing on the last business day of the seventh full calendar quarter following the calendar quarter of the applicable funding date for such term loan, with the aggregate amount payable in respect of each term loan (including interest and other applicable fees) equal to 190% of the principal amount of the tranche 1, tranche 4, tranche 5, tranche 6, and tranche 7 term loans (such amount with respect to each term loan, “Final Payment Amount”). We commenced repayment of the RP Multi Tranche Loans in the fourth quarter of 2023 and will pay approximately $20.2 million in interest and principal on the term loans in 2026.
RP Aficamten Royalty Purchase Agreement
Under the RP Aficamten RPA, RPI ICAV purchased rights to certain revenue streams from net sales of pharmaceutical products containing aficamten by us, our affiliates and our licensees in exchange for up to $150.0 million in consideration, $50.0 million of which was paid on the closing date, $50.0 million of which was paid to us in March 2022 following the initiation of the first pivotal trial in oHCM for aficamten, and $50.0 million of which was paid to us in September 2023 following the initiation of the first pivotal clinical trial in nHCM for aficamten.
RPI ICAV initially purchased the right to receive a percentage of net sales equal to 4.5% for annual worldwide net sales of pharmaceutical products containing aficamten up to $1 billion and 3.5% for annual worldwide net sales of pharmaceutical products containing aficamten in excess of $1 billion, subject to reduction in certain circumstances. However, in May 2024, we entered into the RP Aficamten RPA Amendment to restructure the royalty so that RPI will now receive 4.5% up to $5.0 billion of worldwide annual net sales of aficamten and 1% above $5.0 billion of worldwide annual net sales. Our liability to RPI ICAV is referred to as the “RP Aficamten Liability”.
We account for the RP Aficamten Liability as a liability primarily because we have significant continuing involvement in generating the related revenue stream from which the liability will be repaid. When aficamten is commercialized and royalties become due, we will recognize the portion of royalties paid to RPI ICAV as a decrease to the RP Aficamten Liability and a corresponding reduction in cash.
The carrying amount of the RP Aficamten Liability is based on our estimate of the future royalties to be paid to RPI ICAV over the life of the arrangement as discounted using an imputed rate of interest. The imputed rate of interest on the carrying value of the RP Aficamten Liability was approximately 26.1% as of June 30, 2026 and 20.5% as of June 30, 2025.
Convertible Notes
On November 13, 2019, we issued $138.0 million aggregate principal amount of 2026 Notes. On July 6, 2022, we issued $540.0 million aggregate principal amount of 2027 Notes and used approximately $140.3 million of the net proceeds from the offering of 2027 Notes and issued 8,071,343 shares of common stock to repurchase approximately $116.9 million aggregate principal amount of the 2026 Notes pursuant to privately negotiated exchange agreements entered into with certain holders of the 2026 Notes concurrently with the pricing of the offering of the 2027 Notes. As a result of the partial repurchase of the 2026 Notes, we recorded a debt conversion expense of $22.2 million, consisting of the difference between the consideration to the holders pursuant to the exchange agreements and the if-converted value of the 2026 Notes under the original terms.
On September 19, 2025, we issued $750.0 million aggregate principal amount of 2031 Notes and used approximately $402.5 million of the net proceeds from the offering of 2031 Notes and issued 2,168,806 shares of common stock to repurchase approximately $399.5 million aggregate principal amount of the 2027 Notes pursuant to privately negotiated exchange agreements entered into with certain holders of the 2027 Notes concurrently with the pricing of the offering of the 2031 Notes. This resulted in recording debt conversion expense in the third quarter of 2025 of $121.2 million, consisting of the difference between the consideration to the holders pursuant to the exchange agreements and the if-converted value of the 2027 Notes under the original terms.
During the three months ended June 30, 2026, holders converted the remaining $21.1 million aggregate principal amount of the 2026 Notes into 2,002,817 shares of our common stock, together with an immaterial amount of cash paid in lieu of fractional shares. The conversions were completed in accordance with the original conversion terms of the 2026 Notes, and no gain or loss was recognized. As a result, the 2026 Notes were fully converted and no principal amount of 2026 Notes remained outstanding as of June 30, 2026.
As of June 30, 2026, there remains $140.5 million of aggregate principal amount of 2027 Notes outstanding reflected in long term liabilities, and $750.0 million of aggregate principal amount of 2031 Notes outstanding in long term liabilities. The 2027 Notes are redeemable, in whole or in part (subject to the Partial Redemption Limitation, in the case of the 2027 Notes), at our option at any time, and from time to time, and, in the case of any partial redemption, on or before the 60th scheduled trading day before the applicable maturity date, at a cash redemption price equal to the principal amount of the relevant Convertible Notes to be redeemed, plus accrued and unpaid interest, if any, to, but excluding, the redemption date but only if the last reported sale price per share of our common stock exceeds 130% of the conversion price for the relevant notes on (1) each of at least 20 trading days, whether or not consecutive, during the 30 consecutive trading days ending on, and including, the trading day immediately before the date we may send the related redemption notice; and (2) the trading day immediately before the date we may send such notice. On or after October 6, 2028, the 2031 Notes will be redeemable, in whole or in part (subject to the Partial Redemption Limitation), at our option at any time and from time to time, and, in the case of any partial redemption, on or before the 40th scheduled trading day before the maturity date for the 2031 Notes, at a cash redemption price equal to the principal amount of the 2031 Notes to be redeemed, plus accrued and unpaid interest, if any, to, but excluding, the redemption date but only if the 2031 Notes are also freely tradable and all accrued and unpaid additional interest, if any, has been paid in full, as of the first interest payment date occurring on or before such redemption notice date, and the last reported sale price per share of our common stock exceeds 130% of the conversion price for the 2031 Notes on (1) each of at least 20 trading days, whether or not consecutive, during the 30 consecutive trading days ending on, and including, the trading day immediately before the date we may send the related redemption notice; and (2) the trading day immediately before the date we may send such notice. During the three months ended June 30, 2026, the conditions allowing holders of the 2027 Notes to convert were met. As a result, the 2027 Notes are convertible as of June 30, 2026.
Greater China Out-license for Aficamten
In July 2020, we entered into a license and collaboration agreement with Corxel, pursuant to which we granted to Corxel an exclusive license to develop and commercialize aficamten in China and Taiwan. In December 2024, Corxel assigned its rights and obligations under our license and collaboration agreement to Genzyme Corporation, an affiliate of Sanofi. In 2024, we recognized $15.0 million dollars from Corxel in connection with a modification of the original license prior to the assignment of Corxel's rights under our license and collaboration agreement for the development and commercialization of aficamten to Sanofi, and we may be eligible for another $10.0 million milestone payment from Corxel if certain conditions are met.
In the fourth quarter of 2025, we recognized $15.0 million in aggregate milestone revenues from Sanofi upon approval of MYQORZO in each of the United States and China. We may be eligible to receive future milestone payments from Sanofi totaling up to $135.0 million for the achievement of certain development and commercial milestone events in connection to sales of MYQORZO and development of aficamten in nHCM.
In addition, Sanofi will pay us tiered royalties in the low-to-high teens range on the net sales of pharmaceutical products containing aficamten, including MYQORZO, in China and Taiwan, subject to certain reductions for generic competition, patent expiration and payments for licenses to third party patents. Sales to patients commenced in the first quarter of 2026. The Sanofi Aficamten License Agreement, unless terminated earlier, will continue on a market-by-market basis until expiration of the relevant royalty term. We expect royalty revenues in 2026 to be immaterial as Sanofi begins initial commercialization activities in China.
Japan Out-license for Aficamten
In November 2024, we entered into a license and collaboration agreement with Bayer Consumer Care AG, an affiliate of Bayer AG, pursuant to which we granted to Bayer an exclusive license to develop and commercialize aficamten in Japan, subject to certain reserved development rights. Under the terms of the Bayer License Agreement, we received an up-front payment of €50.0 million (equivalent to $52.4 million at the time of payment) which was recorded as deferred revenue at December 31, 2024 and was recognized in 2025 upon completion of certain performance technology transfer obligations. We recognized revenue associated with two clinical milestones totaling €10 million in 2025. We recognized an additional €10 million milestone in the first quarter of 2026 as a result of our first commercial sale of MYQORZO in the United States. We may also be eligible to receive up to an additional €70 million in milestones upon first commercial sale of aficamten in each of oHCM and nHCM in Japan and nHCM in the United States. We are also eligible for an additional €490 million in commercial milestone payments upon the achievement by Bayer of certain sales milestones and tiered royalties on the net sales of pharmaceutical products containing aficamten in Japan ranging from the high teens to the low thirty percents, subject to certain reductions for generic competition, expiration of certain patents and payments for licenses to third-party patents, until the latest of the expiration of certain patents, the expiration of regulatory exclusivity for the Product in Japan, and the end of a minimum specified term.
At-the-Market Sales of Common Stock
On February 27, 2025, we entered into an Open Market Sale AgreementSM with Jefferies LLC under which we may offer and sell, from time to time, at our sole discretion, shares of Common Stock in “at the market offerings” pursuant to Rule 415(a)(4) under the Securities Act of 1933 through Jefferies LLC, as sales agent. As of June 30, 2026, we have not sold any shares of Common Stock under the Open Market Sale AgreementSM with Jefferies LLC.
Future Uses of Cash
We expect that selling, general and administrative expenses will significantly increase in 2026. In December 2025, MYQORZO was approved by the FDA, and accordingly, our sales and marketing expenses will increase significantly as we engage in commercialization activities in the United States. In February 2026, the European Commission approved MYQORZO® (aficamten), 5 mg, 10 mg, 15 mg and 20 mg tablets for the treatment of symptomatic (NYHA class II-III) obstructive hypertrophic cardiomyopathy in adult patients, which means that we will significantly increase commercial readiness activities in Europe, initially in Germany, with commercial readiness activities in other major European countries to follow.
In future periods, we also expect to incur substantial costs as we expand our research programs and continue development activities, including for the conduct of our on-going clinical trials for aficamten, omecamtiv mecarbil, ulacamten and CK-089. We expect to incur significant research and development expenses as we advance the research and development of compounds from our other muscle biology programs through research to candidate selection to clinical development, and we expect to file investigational new drug applications. Cytokinetics and multiple third-party contract development manufacturing organizations entered into various scopes of work with respect to the manufacturing of aficamten. As of June 30, 2026, we have approximately $18.6 million of non-cancellable commitments related to purchases of materials and inventory manufacturing agreements.
Our future capital uses and requirements depend on numerous factors. These factors include, but are not limited to, the following:
•the initiation, progress, timing, scope and completion of preclinical research, non-clinical development, CMC, and clinical trials for our drug candidates and other compounds;
•the time, costs and outcomes of regulatory reviews or other regulatory actions related to our drugs and drug candidates,
•the jurisdictions in which we are granted regulatory approvals and thus are able to successfully launch our products for commercial sale;
•delays that may be caused by requirements of regulatory agencies;
•our level of funding for the development of current or future drugs and drug candidates;
•the number of drug candidates we pursue and the stage of development that they are in;
•the costs involved in filing and prosecuting patent applications and attacking, enforcing or defending patent claims;
•our ability to establish and maintain selected strategic alliances required for the development of drug candidates and commercialization of our drugs and future drugs, if any;
•our plans or ability to expand our drug development capabilities, including our capabilities to conduct clinical trials for our drug candidates;
•our plans or ability to engage third-party manufacturers for our drugs or drug candidates;
•our plans or ability to build or access sales and marketing capabilities, including commercial infrastructure and distribution capabilities, and to achieve market acceptance for MYQORZO and potential future drugs;
•the expansion and advancement of our research programs;
•the hiring of additional employees and consultants;
•the acquisition of technologies, products and other business opportunities that require financial commitments;
•our revenues from commercialization of MYQORZO and successful development and commercialization of any other drug candidates;
•the cost of additional construction to expand our headquarters in South San Francisco and the cost in relation to expanding our leased office facilities in Radnor, Pennsylvania or other leased office spaces in Europe; and
•the payments due for interest on the term loan and convertible debt;
We have incurred an accumulated deficit of approximately $3.9 billion since inception and there can be no assurance that we will attain profitability. Although we have one approved product at this time, we remain subject to risks common to clinical-stage companies including, but not limited to, development of new drug candidates, dependence on key personnel, and the ability to obtain additional capital as needed to fund our future plans. Our liquidity will be impaired if sufficient additional capital is not available on terms acceptable to us, if at all. Until we achieve profitable operations, we intend to continue to fund operations through payments from strategic collaborations, additional sales of equity securities, grants and other financings. With the recent FDA approval of MYQORZO in December 2025, we have only recently started generating revenues from the commercial sale of our drugs. Therefore, our success is dependent on our ability to generate substantial revenues from MYQORZO or potentially obtain additional capital by entering into new strategic collaborations and/or through financings, and ultimately on our and our collaborators’ ability to successfully develop and market one or more of our drug candidates. We cannot be certain that sufficient funds will be available from such collaborators or financings when needed or on satisfactory terms, including as a result of economic conditions, general global economic uncertainty, political change, war, the effects of inflationary pressures, including those resulting from tariffs and escalating trade tensions, and other factors including past and potential future bank failures in the United States. Additionally, there can be no assurance that MYQORZO or any of our drug candidates will be accepted in the marketplace or that any future products can be developed or manufactured at an acceptable cost. These factors could have a material adverse effect on our future financial results, financial position and cash flows.
Based on the current planning assumptions, we believe that our existing cash and cash equivalents, investments and interest earned on investments will be sufficient to meet our projected operating requirements for at least the next 12 months. If, at any time, our prospects for internally financing programs and activities decline, we may decide to reduce expenses across the business. Alternatively, we may raise funds through strategic relationships, public or private financings or other arrangements. There can be no assurance that funding, if needed, will be available on attractive terms, or at all, or in accordance with our planned timelines. Furthermore, financing obtained through future strategic relationships may require us to forego certain commercialization and other rights to our drug candidates. Similarly, any additional equity financing may be dilutive to stockholders and debt financing, if available, may involve restrictive covenants. Our failure to raise capital as and when needed could have a negative impact on our financial condition and our ability to pursue our business strategy.
Segment Information
We have one primary business activity and operate in one reportable segment.
Critical Accounting Policies and Significant Estimates
The accounting policies that we consider to be our most critical (i.e., those that are most important to the portrayal of our financial condition and results of operations and that require our most difficult, subjective or complex judgments), the effects of those accounting policies applied and the judgments made in their application are summarized in “Item 7 — Management’s Discussion and Analysis of Financial Condition and Results of Operations — Critical Accounting Policies and Significant Estimates” in our Annual Report on Form 10-K for the fiscal year ended December 31, 2025. There have been no material changes to our critical accounting policies and significant estimates in the six months ended June 30, 2026 , except for the following:
Net Product Revenue
We recognize revenue from product sales at a point in time when our customer is deemed to have obtained control of the product, which generally occurs upon receipt or acceptance by our customer. In order to determine the transaction price, we estimate, utilizing the expected value method, the amount of variable consideration to which we will be entitled. Our product sales are subject to various deductions, including distribution-related fees, rebates under government programs, rebates for commercial payors, and amounts under our co-pay assistance program. The distribution-related fees include a prompt pay discount and fees for specialty pharmaceutical and specialty distributor customers. The distribution-related fees are not subject to significant estimation uncertainty. However, other sales deductions require us to make estimates, particularly related to the payor mix. We estimate the percentage of product sales which will ultimately be subject to commercial payor rebates, the Medicare Part D Manufacturer Rebate Program, Medicaid, and other federal programs. We also estimate the percentage of product sales which will ultimately go to 340B hospitals. As we have limited history for the sales of MYQORZO, we estimated our payor mix based upon our market research and industry data for similar cardiovascular products. As we gain more historical experience for the sales of MYQORZO, we will update our estimates which will result in adjustments to current period revenues.
Inventories
Inventories, which consist of raw materials, work in process and finished goods, are stated at the lower of cost or estimated net realizable value, using standard costs, based on a first-in, first-out method. We have entered into manufacturing and supply agreements for the manufacture or purchase of raw materials and production supplies in prior years. Our inventories include the direct purchase cost of materials and supplies, charges from contract manufacturing organizations and manufacturing overhead costs. We will periodically review our inventories for factors that could impact the future recoverability and realization of future sales, which require estimates and judgments. We will analyze our inventory levels quarterly and write down inventories subject to expiry, in excess of expected requirements or that has a cost basis in excess of its expected net realizable value. These write downs will be charged to cost of goods sold in the accompanying consolidated statements of operations and comprehensive loss.
We received FDA approval for MYQORZO on December 19, 2025 and began capitalizing inventories upon FDA approval. Costs incurred prior to approval have been recorded as research and development expense in our consolidated statement of operations and comprehensive loss. As a result, inventory balances and cost of goods sold for the next several quarters are expected to reflect a lower average per unit cost of materials.
ITEM 3. QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK
Our exposure to market risk has not changed materially since our disclosures in "Item 7A —Quantitative and Qualitative Disclosures About Market Risk” in our Annual Report on Form 10-K for the year ended December 31, 2025, except for the following:
Interest Rate Risk
We are exposed to market risk related to changes in interest rates. As of June 30, 2026, our cash and investments totaled $1.7 billion, comprising U.S. Treasury securities, U.S. and non-U.S. government agency bonds, commercial paper, a global portfolio of corporate debt, money market funds, and repurchase agreements backed by U.S. Treasury securities.
Our investments are subject to interest rate risk and could fall in value if market interest rates increase. We have not been exposed to, nor do we anticipate being exposed to, material risks due to changes in interest rates. A hypothetical 1% increase in market interest rates would result in a decline in the value of our investments of approximately $10.9 million and $6.0 million as of June 30, 2026 and December 31, 2025, respectively.
In addition, we have elected the fair value option for certain liabilities. The fair value of the liabilities related to 2024 RP OM Loan Agreement, the RP Ulacamten RPA, and the derivatives of the RP Multi Tranche Loan Agreement will increase as market interest rates decrease. In addition, the fair value of the liabilities may fluctuate based upon changes in the Company’s credit rating. Changes in the interest rate environment and the credit rating of the Company could have an effect on our future earnings. For example, a hypothetical 1% decrease in the discount rates used to measure the 2024 RP OM Loan Agreement, the RP Ulacamten RPA, and the derivatives of the RP Multi Tranche Loan Agreement would result an increase in the fair value, and the recognition of a loss, of approximately $3.7 million as of June 30, 2026. During the three and six months ended June 30, 2026, we recognized a gain on the change in the estimated fair value of liabilities of approximately $2.4 million and $0.8 million, respectively, primarily due to changes in the discount rates used to measure the 2024 RP OM Loan Agreement and the RP Ulacamten RPA. The discount rates ranged from 14% to 17% for the three months ended June 30, 2026 and 10% to 18% for the three months ended June 30, 2025.
ITEM 4. CONTROLS AND PROCEDURES
(a) Evaluation of disclosure controls and procedures
We maintain disclosure controls and procedures that are designed to ensure that information required to be disclosed in our reports under the Exchange Act, and the rules and regulations thereunder, is recorded, processed, summarized and reported within the time periods specified in the SEC’s rules and forms and that such information is accumulated and communicated to our management, including our principal executive officer and principal financial officer, or persons performing similar functions, as appropriate, to allow for timely decisions regarding required or necessary disclosure. In designing and evaluating the disclosure controls and procedures, management recognizes that any controls and procedures, no matter how well designed and operated, can provide only reasonable, not absolute, assurance of achieving the desired control objectives, and we are required to apply judgment in evaluating the cost-benefit relationship of possible controls and procedures. Based on the evaluation of our disclosure controls and procedures as of June 30, 2026, our Chief Executive Officer and Chief Financial Officer concluded that, as of such date, our disclosure controls and procedures were effective at the reasonable assurance level.
(b) Changes in internal control over financial reporting
Except for new controls implemented related to product revenues and inventory, there were no changes in our internal control over financial reporting that occurred during the quarter ended June 30, 2026, that have materially affected, or are reasonably likely to materially affect, our internal control over financial reporting.
(c) Limitations on the effectiveness of controls
A control system, no matter how well-conceived and operated, can provide only reasonable, not absolute, assurance that the objectives of the controls are met. Because of the inherent limitations in all control systems, no evaluation of controls can provide absolute assurance that all control issues, if any, within a company have been detected. Accordingly, our disclosure controls and procedures are designed to provide reasonable, not absolute, assurance that the objectives of our disclosure control system are met.
PART II. OTHER INFORMATION
ITEM 1. LEGAL PROCEEDINGS
From time to time, the Company is a party to legal proceedings in the course of the Company’s business. For a discussion of our material pending legal proceedings, refer to Note 9 – Commitments and Contingencies to our condensed consolidated financial statements included in this Quarterly Report, which is incorporated herein by reference.
In re Cytokinetics, Incorporated Securities Litigation
On September 17, 2025, a putative stockholder class action lawsuit was filed against the Company and its Chief Executive Officer in the United States District Court for the Northern District of California, alleging violations of Sections 10(b) and 20(a) of the Securities Exchange Act of 1934. The action was purportedly filed on behalf of a class consisting of all investors who purchased or otherwise acquired the Company's common stock between December 27, 2023 and May 6, 2025. The complaint alleges that the Company made materially false and misleading statements regarding the timeline for the NDA regulatory approval process for aficamten and failed to disclose related material risks. The complaint seeks unspecified damages, together with interest, attorneys' fees, and costs.
On December 22, 2025, the Court appointed Gilbert Rosenthal as Lead Plaintiff and approved his selection of Pomerantz LLP as Lead Counsel. The action is now captioned In re Cytokinetics, Incorporated Securities Litigation, Case No. 3:25-cv-07923-RFL. On March 10, 2026, Lead Plaintiff filed an amended complaint, which, among other things, added the Company's Chief Financial Officer as a defendant. The Company filed a motion to dismiss the amended complaint and Lead Plaintiff filed an opposition to the motion. The Company expects to file a reply to the opposition in due course.
The Company disputes the allegations in the amended complaint and intends to vigorously defend against the action.
Pohlmann v. Blum, et al.
On March 9, 2026, a purported stockholder derivative action captioned Pohlmann v. Blum, et al., Case No. 3:26-cv-01998-RFL, was filed in the United States District Court for the Northern District of California against certain of the Company's current and former directors and its Chief Executive Officer, with the Company named as a nominal defendant. The complaint asserts claims for breach of fiduciary duty, aiding and abetting breach of fiduciary duty, unjust enrichment, waste of corporate assets, contribution under the Securities Exchange Act of 1934, and violations of Section 14(a) of the Securities Exchange Act of 1934 and Rule 14a-9 promulgated thereunder. The allegations are based substantially on the same underlying facts and circumstances as those alleged in In re Cytokinetics, Incorporated Securities Litigation and principally concern statements regarding the Company's New Drug Application for aficamten and the subsequent extension of the related PDUFA action date. The complaint seeks, among other relief, unspecified damages on behalf of the Company, disgorgement, corporate governance reforms, and attorneys' fees and costs.
On March 27, 2026, the Court found the derivative action to be related to In re Cytokinetics, Incorporated Securities Litigation and reassigned the matter accordingly. On April 16, 2026, the Court entered an order, pursuant to the parties' stipulation, staying the derivative action in its entirety during the pendency of any motion to dismiss in the securities class action, subject to customary terms.
The Company and the individual defendants dispute the allegations in the derivative action and intend to vigorously defend against the matter.
ITEM 1A. RISK FACTORS
There have been no material changes in our risk factors as previously disclosed in our Quarterly Report on Form 10-Q for the quarter ended March 31, 2026. For a detailed description of our risk factors, refer to Part II, Item 1A, “Risk Factors” of our Quarterly Report on Form 10-Q for the quarter ended March 31, 2026. The risks and uncertainties described in our Quarterly Report on Form 10-Q for the quarter ended March 31, 2026 are not the only ones facing us. Additional risk and uncertainties not presently known to us, or that we currently see as immaterial, may also adversely affect our business.
ITEM 2. UNREGISTERED SALES OF EQUITY SECURITIES AND USE OF PROCEEDS
None.
ITEM 3. DEFAULTS UPON SENIOR SECURITIES
None.
ITEM 4. MINE SAFETY DISCLOSURES
None.
ITEM 5. OTHER INFORMATION
(c) In this Item 5(c) of this quarterly report on Form 10-Q, the terms “officers”, “Rule 10b5-1 trading arrangements” and “non-Rule 10b5-1 trading arrangements” have the meanings ascribed to them in Item 408 of Regulation S-K.
The following directors and officers adopted into or terminated a Rule 10b5-1 trading arrangement during the second quarter of 2026:
•Robert E. Landry. – Mr. Landry, a member of our board of directors, adopted a Rule 10b5-1 trading arrangement on June 12, 2026 that was intended to satisfy the affirmative defense provided for under Rule 10b5-1(c) (the “Landry Plan”). The Landry Plan provides for the sale of up to 2000 shares of our common stock, subject to certain conditions. The Landry Plan will terminate on the earlier of (x) June 4, 2027 and (y) the sale of all securities that are subject to the plan.
•Wendell Wierenga, Ph.D. – Mr. Wierenga, a member of our board of directors, adopted a Rule 10b5-1 trading arrangement on June 10, 2026 that was intended to satisfy the affirmative defense provided for under Rule 10b5-1(c) (the “Wierenga Plan”). The Wierenga Plan provides for the sale of up to 45,714 shares of our common stock, subject to certain conditions. The Wierenga Plan will terminate on the earlier of (x) May 16, 2028 and (y) the sale of all securities that are subject to the plan.
ITEM 6. EXHIBITS
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Incorporated by Reference |
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Exhibit No. |
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Form |
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File No. |
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Filing Date |
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Exh. No. |
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Filed Herewith |
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3.1 |
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Amended and Restated Certificate of Incorporation |
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S-3 |
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333-174869 |
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June 13, 2011 |
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3.1 |
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3.2 |
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Certificate of Amendment of Amended and Restated Certificate of Incorporation |
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10-Q |
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000-50633 |
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August 4, 2011 |
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3.2 |
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3.3 |
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Certificate of Amendment of Amended and Restated Certificate of Incorporation |
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8-K |
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000-50633 |
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June 25, 2013 |
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5.1 |
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3.4 |
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Certificate of Amendment of Amended and Restated Certificate of Incorporation |
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8-K |
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000-50633 |
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May 20, 2016 |
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3.1 |
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3.5 |
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Certificate of Amendment of Amended and Restated Certificate of Incorporation |
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10-Q |
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000-50633 |
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August 3, 2023 |
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3.5 |
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3.6 |
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Certificate of Amendment of Amended and Restated Certificate of Incorporation |
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10-Q |
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000-50633 |
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August 7, 2025 |
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3.6 |
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3.7 |
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Amended and Restated Bylaws |
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8-K |
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000-50633 |
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February 17, 2023 |
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3.1 |
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4.1 |
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Specimen Common Stock Certificate |
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10-Q |
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000-50633 |
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May 9, 2007 |
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4.1 |
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4.2 |
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Form of Warrant Issuable to Oxford Finance LLC pursuant to that certain Loan and Security Agreement, dated as of May 17, 2019, by and among the Company, Oxford Finance LLC and Silicon Valley Bank |
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10-Q |
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000-50633 |
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August 9, 2019 |
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4.2 |
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4.3 |
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Base Indenture, dated November 13, 2019, between the Company and U.S. Bank National Association, as Trustee |
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8-K |
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000-50633 |
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November 13, 2019 |
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4.1 |
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4.4 |
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First Supplemental Indenture, dated November 13, 2019, between the Company and U.S. Bank National Association, as Trustee (including the form of 4.00% Convertible Senior Notes due 2026) |
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8-K |
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000-50633 |
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November 13, 2019 |
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4.2 |
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4.5 |
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Indenture, dated July 6, 2022, between the Company and U.S. Bank Trust Company, National Association, as Trustee (including the form of 3.50% Convertible Senior Notes due 2027) |
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8-K |
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000-50633 |
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July 6, 2022 |
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4.1 |
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4.6 |
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Indenture, dated as of September 19, 2025, between the Company and U.S. Bank Trust Company, National Association, as Trustee (including the form of 1.75% Convertible Senior Notes due 2031) |
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8-K |
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000-50633 |
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September 22, 2025 |
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4.1 |
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4.6 |
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Certificate of Designation |
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8-K |
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000-50633 |
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April 18, 2011 |
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4.5 |
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4.7 |
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Certificate of Designation |
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8-K |
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000-50633 |
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June 30, 2012 |
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4.1 |
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4.8 |
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Certificate of Change of Registered Agent |
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10-K |
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000-50633 |
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March 1, 2023 |
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4.9 |
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10.1 |
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Amended and restated 2015 Employee Stock Purchase Plan |
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S-8 |
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000-50633 |
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May 27, 2025 |
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99.1 |
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31.1 |
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Certification of Principal Executive Officer pursuant to Rule 13a-14(a) and Rule 15d-14(a) of the Securities Exchange Act, as amended |
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X |
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31.2 |
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Certification of Principal Financial Officer pursuant to Rule 13a-14(a) and Rule 15d-14(a) of the Securities Exchange Act, as amended |
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X |
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32.1 |
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Certifications of the Principal Executive Officer and Principal Financial Officer pursuant to 18 U.S.C 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002(1) |
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X |
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101.INS |
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Inline XBRL Instance Document (the Instance Document does not appear in the Interactive Data File because its XBRL tags are embedded within the Inline XBRL document) |
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X |
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101.SCH |
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Inline XBRL Taxonomy Extension Schema with Embedded Linkbase Document |
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104 |
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Cover Page Interactive Data File (formatted as Inline XBRL and contained in Exhibit 101) |
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X |
(1) This certification accompanies the Form 10-Q to which it relates, is not deemed filed with the Securities and Exchange Commission and is not to be incorporated by reference into any filing of the Registrant under the Securities Act of 1933, as amended, or the Securities Exchange Act of 1934, as amended (whether made before or after the date of the Form 10-Q), irrespective of any general incorporation language contained in such filing. |
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, thereunto duly authorized.
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Dated: August 6, 2026 |
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CYTOKINETICS, INCORPORATED |
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(Registrant) |
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/s/ Robert I. Blum |
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Robert I. Blum |
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President and Chief Executive Officer |
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(Principal Executive Officer) |
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/s/ Sung H. Lee |
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Sung H. Lee |
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Executive Vice President, Chief Financial Officer |
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(Principal Financial Officer) |
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