Cytokinetics Reports Fourth Quarter 2022 Financial Results
Company Received Complete Response Letter from FDA for New Drug Application for Omecamtiv Mecarbil
Data from Cohort 4 of REDWOOD-HCM to be Presented at the
Second Interim Analysis of COURAGE-ALS Expected to Occur in Q2 2023
Company Provides 2023 Financial Guidance; More than 2 Years of Cash Runway
“Aficamten remains our top priority and is advancing in a broad development program with emphasis on the conduct of SEQUOIA-HCM, our pivotal Phase 3 clinical trial in obstructive HCM, and the start of two additional Phase 3 trials,” said
Q4 and Recent Highlights
Cardiac Muscle Programs
omecamtiv mecarbil (cardiac myosin activator)
Cytokinetics announced that theU.S. Food and Drug Administration (FDA) issued a Complete Response Letter (CRL) regarding the New Drug Application (NDA) for omecamtiv mecarbil, stating that GALACTIC-HF is not sufficiently persuasive to establish substantial evidence of effectiveness for reducing the risk of heart failure events and cardiovascular death in adults with chronic heart failure with reduced ejection fraction, in lieu of evidence from at least two adequate and well-controlled clinical investigations.- The
European Medicines Agency (EMA) accepted the Marketing Authorization Application (MAA) for omecamtiv mecarbil for the treatment of advanced or worsening HFrEF. Ji Xing Pharmaceuticals announced that theCenter for Drug Evaluation (CDE) of theNational Medical Products Administration (NMPA) of the People’sRepublic of China has accepted the submission of the New Drug Application (NDA) for omecamtiv mecarbil for the treatment of heart failure with reduced ejection fraction (HFrEF) inChina .- Presented results from two additional analyses from GALACTIC-HF (Global Approach to Lowering Adverse Cardiac Outcomes Through Improving Contractility in Heart Failure) at the American Heart Association Scientific Sessions 2022, including one showing that the estimated cost reduction due to heart failure events avoided due to treatment with omecamtiv mecarbil averaged
$6,052 per patient (26.9% reduction) at three years, and one that showed that women had lower quality of life at baseline and a lower rate of the primary composite outcome, but the treatment benefit of omecamtiv mecarbil did not differ between men and women (interaction p=0.68).
aficamten (cardiac myosin inhibitor)
- Continued enrolling patients with obstructive hypertrophic cardiomyopathy (HCM) in SEQUOIA-HCM (Safety, Efficacy, and Quantitative Understanding of Obstruction Impact of Aficamten in HCM), our first Phase 3 trial of aficamten in the
U.S. andEurope . - Completed enrollment of patients with non-obstructive HCM in Cohort 4 of REDWOOD-HCM (Randomized Evaluation of Dosing With CK-274 in Obstructive Outflow Disease in HCM).
- Continued preparations for the second Phase 3 clinical trial of aficamten as monotherapy in patients with obstructive HCM, MAPLE-HCM (Metoprolol vs Aficamten in Patients with LVOT Obstruction on Exercise Capacity in HCM).
- Hired a
U.S. marketing leader and continued to advance the go-to-market strategy for aficamten in theU.S. - Published a manuscript entitled “Phase 2 Study of Aficamten in Patients with Obstructive Hypertrophic Cardiomyopathy” in the
Journal of the American College of Cardiology . - Published a manuscript entitled “Pharmacokinetics of a Single Dose of Aficamten (CK-274) on Cardiac Contractility in a A31P MYBPC3 Hypertrophic Cardiomyopathy Cat Model” in
Journal of Veterinary Pharmacology and Therapeutics .
Skeletal Muscle Program
reldesemtiv (fast skeletal muscle troponin activator (FSTA))
- Continued enrolling patients with ALS in COURAGE-ALS (Clinical Outcomes Using Reldesemtiv on ALSFRS-R in a Global Evaluation in ALS), the Phase 3 clinical trial of reldesemtiv.
- Announced that the Data Monitoring Committee (DMC) for COURAGE-ALS (Clinical Outcomes Using Reldesemtiv on ALSFRS-R in a Global Evaluation in ALS) convened to review unblinded data from the clinical trial for the first interim analysis and recommended that conduct of the Phase 3 trial continue.
- Presented results from an additional analysis from FORTITUDE-ALS (Functional Outcomes in a Randomized Trial of Investigational Treatment with CK-2127107 to Understand Decline in Endpoints – in ALS), the Phase 2 clinical trial of reldesemtiv showing that the ENCALS predicted risk scores are strongly correlated with the rate of decline in ALSFRS-R.
- Published a manuscript entitled “MiToS and King’s staging as clinical outcome measures in ALS: a retrospective analysis of the FORTITUDE-ALS trial” in Amyotrophic Lateral Sclerosis and Frontotemporal Degeneration.
- Continued to advance new muscle directed compounds and conduct IND-enabling studies with the expectation of our potentially moving 1-2 drug candidates into clinical development this year.
- Continued research activities directed to our other muscle biology research programs.
- Published a manuscript entitled “Distinct Mechanisms for Increased Cardiac Contraction Through Selective Alteration of Either Myosin or Troponin Activity” in the
Journal of the American College of Cardiology : Basic to Translational Science.
Corporate
- Joined with the European Organisation for Rare Diseases (EURORDIS) and the National Organization for Rare Disorders (NORD) to recognize Rare Disease Day®, an international campaign elevating the public understanding of rare diseases.
- Awarded Cytokinetics Communications Grants to patient advocacy organizations serving the heart failure, HCM and ALS communities to support increased capacity in communications, awareness building and community engagement for nonprofit organizations serving the patient community.
2023 Corporate Milestones
Cardiac Muscle Programs
omecamtiv mecarbil (cardiac myosin activator)
- Request meeting with FDA to understand what may be required to support potential approval of omecamtiv mecarbil in
the United States . - Engage with EMA regarding the MAA for the treatment of HFrEF.
aficamten (cardiac myosin inhibitor)
- Present data from Cohort 4 of REDWOOD-HCM at the
American College of Cardiology’s 72nd Annual Scientific Session. - Present data from 48 weeks of treatment with aficamten in FOREST-HCM at the
American College of Cardiology’s 72nd Annual Scientific Session. - Complete patient enrollment in SEQUOIA-HCM in Q2 2023, with results expected in Q4 2023.
- Begin MAPLE-HCM, the second Phase 3 clinical trial of aficamten as monotherapy in patients with obstructive HCM in Q2 2023.
- Begin a Phase 3 clinical trial of aficamten in non-obstructive HCM in 2H 2023.
- Advance
U.S. go-to-market strategy for aficamten.
CK-3828136 (CK-136) (cardiac troponin activator)
- Expect data from the Phase 1 study of CK-136 in 2H 2023.
Skeletal Muscle Program
reldesemtiv (fast skeletal muscle troponin activator (FSTA))
- Expect the Data Monitoring committee to conduct the second interim analysis from COURAGE-ALS in Q2 2023, which will assess for futility and allow for a fixed increase in total enrollment, if deemed necessary, to augment the statistical power of the trial.
- Complete patient enrollment in COURAGE-ALS in Q2 2023, subject to second interim analysis.
- Expect to advance CK-4021586, an additional cardiac myosin inhibitor, into clinical development in 1H 2023.
Financials
Revenues for the three and twelve months ended
Research and development expenses for the three and twelve months ended
General and administrative expenses for the three and twelve months ended
2023 Financial Guidance
The company today announced financial guidance for 2023. The company anticipates revenue will be up to
Conference Call and Webcast Information
Members of Cytokinetics’ senior management team will review the company’s fourth quarter results on a conference call today at
About
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Forward-Looking Statements
This press release contains forward-looking statements for purposes of the Private Securities Litigation Reform Act of 1995 (the “Act”).
CYTOKINETICS® and the
Contact:
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(415) 290-7757
Condensed Consolidated Balance Sheets | ||||||||
(in thousands) | ||||||||
(unaudited) | ||||||||
ASSETS | ||||||||
Current assets: | ||||||||
Cash and short-term investments | $ | 782,577 | $ | 471,638 | ||||
Other current assets | 12,609 | 64,034 | ||||||
Total current assets | 795,186 | 535,672 | ||||||
Long-term investments | 46,708 | 152,050 | ||||||
Property and equipment, net | 80,453 | 73,271 | ||||||
Operating lease right-of-use assets | 82,737 | 73,138 | ||||||
Other assets | 9,691 | 7,188 | ||||||
Total assets | $ | 1,014,775 | $ | 841,319 | ||||
LIABILITIES AND STOCKHOLDERS’ (DEFICIT) EQUITY | ||||||||
Current liabilities: | ||||||||
Accounts payable and accrued liabilities | $ | 69,707 | $ | 55,457 | ||||
Short-term lease liability | 12,829 | 14,863 | ||||||
Other current liabilities | 2,081 | 1,540 | ||||||
Total current liabilities | 84,617 | 71,860 | ||||||
Term loan, net | 63,810 | 47,367 | ||||||
Convertible notes, net | 545,808 | 95,471 | ||||||
Liabilities related to revenue participation right purchase agreements, net | 300,501 | 179,072 | ||||||
Long-term deferred revenue | — | 87,000 | ||||||
Long-term operating lease liabilities | 126,895 | 112,229 | ||||||
Other non-current liabilities | 1,044 | 4,457 | ||||||
Total liabilities | 1,122,675 | 597,456 | ||||||
Commitments and contingencies | ||||||||
Stockholders’ (deficit) equity: | ||||||||
Common stock | 94 | 84 | ||||||
Additional paid-in capital | 1,481,590 | 1,452,268 | ||||||
Accumulated other comprehensive loss | (3,590 | ) | (869 | ) | ||||
Accumulated deficit | (1,585,994 | ) | (1,207,620 | ) | ||||
Total stockholders’ (deficit) equity | (107,900 | ) | 243,863 | |||||
Total liabilities and stockholders’ (deficit) equity | $ | 1,014,775 | $ | 841,319 |
Condensed Consolidated Statements of Operations | |||||||||||||||
(in thousands except per share data) | |||||||||||||||
(unaudited) | |||||||||||||||
Three Months Ended |
Years Ended |
||||||||||||||
2022 | 2021 | 2022 | 2021 | ||||||||||||
Revenues: | |||||||||||||||
Research and development revenues | $ | 1,957 | $ | 744 | $ | 6,588 | $ | 10,572 | |||||||
License revenues | — | 54,856 | — | 54,856 | |||||||||||
Milestone revenues | — | — | 1,000 | 5,000 | |||||||||||
Realization of revenue participation right purchase agreement | — | — | 87,000 | — | |||||||||||
Total revenues | 1,957 | 55,600 | 94,588 | 70,428 | |||||||||||
Operating expenses: | |||||||||||||||
Research and development | 75,018 | 43,498 | 240,813 | 159,938 | |||||||||||
General and administrative | 53,969 | 33,806 | 177,977 | 96,803 | |||||||||||
Total operating expenses | 128,987 | 77,304 | 418,790 | 256,741 | |||||||||||
Operating loss | (127,030 | ) | (21,704 | ) | (324,202 | ) | (186,313 | ) | |||||||
Interest expense | (7,057 | ) | (4,218 | ) | (19,414 | ) | (16,440 | ) | |||||||
Loss on settlement of debt | — | — | (24,939 | ) | — | ||||||||||
Non-cash interest expense on liabilities related to revenue participation right purchase agreements | (9,212 | ) | (4,271 | ) | (31,742 | ) | (12,892 | ) | |||||||
Interest and other income (loss), net | 5,919 | (377 | ) | 11,342 | 331 | ||||||||||
Net loss before income taxes | (137,380 | ) | (30,570 | ) | (388,955 | ) | (215,314 | ) | |||||||
Income tax benefit | — | — | — | — | |||||||||||
Net loss | $ | (137,380 | ) | $ | (30,570 | ) | $ | (388,955 | ) | $ | (215,314 | ) | |||
Net loss per share — basic and diluted | $ | (1.45 | ) | $ | (0.36 | ) | $ | (4.33 | ) | $ | (2.80 | ) | |||
Weighted-average shares in net loss per share — basic and diluted | 94,681 | 84,087 | 89,825 | 76,886 |

Source: Cytokinetics, Incorporated