Cytokinetics Reports Fourth Quarter 2020 Financial Results
Company Plans to Meet with FDA in Q1 to Discuss Results of GALACTIC-HF
Enrollment Completed in Cohort 2 of REDWOOD-HCM; Results Expected Mid-Year
Company Provides 2021 Financial Guidance; More Than Two Years of Cash Runway
“In the fourth quarter, we were pleased to present the results of GALACTIC-HF which demonstrated a positive effect on the primary composite endpoint of cardiovascular death or heart failure events in patients receiving standard of care plus omecamtiv mecarbil, with potentially larger treatment effects in patients with increasingly lower ejection fractions. In the next few weeks, we plan to discuss the results of GALACTIC-HF with FDA as may inform a potential registration path,” said
Q4 and Recent Highlights
Cardiac Muscle Programs
omecamtiv mecarbil (cardiac myosin activator)
- Results from GALACTIC-HF (Global Approach to Lowering Adverse Cardiac Outcomes Through Improving Contractility in Heart Failure), the Phase 3 clinical trial of omecamtiv mecarbil, were presented and published online.
- GALACTIC-HF demonstrated a statistically significant effect of treatment with omecamtiv mecarbil to reduce risk of the primary composite endpoint of cardiovascular (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.
- No reduction in the secondary endpoint of time to CV death was observed and no other secondary endpoints were met in accordance with the prespecified statistical analysis.
- Adverse events and treatment discontinuation of study drug were balanced between the treatment arms. In general, the overall rates of myocardial ischemia, ventricular arrhythmias and death were similar between treatment and placebo groups.
- The effect of omecamtiv mecarbil was consistent across most prespecified subgroups and with a potentially greater treatment effect suggested in patients with a lower left ventricular ejection fraction (LVEF).
- GALACTIC-HF demonstrated a statistically significant effect of treatment with omecamtiv mecarbil to reduce risk of the primary composite endpoint of cardiovascular (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.
- Supplemental analyses from GALACTIC-HF were presented that demonstrated a greater treatment effect of omecamtiv mecarbil in patients with lower LVEF as well as characteristics that may indicate advanced heart failure, such as being hospitalized within the last 3 months, higher N-terminal-pro brain natriuretic peptide levels and lower blood pressures.
- Continued conduct of METEORIC-HF (Multicenter Exercise Tolerance Evaluation of Omecamtiv Mecarbil Related to Increased Contractility in Heart Failure), the second Phase 3 trial of omecamtiv mecarbil.
- Presented findings from analyses of claims data and electronic health records related to heart failure, including analyses of the high spending and unmet need, underscoring the growing economic burden of this disease.
- Conducted market research with physicians and payors and continued other commercial planning activities for omecamtiv mecarbil.
CK-3828136 (CK-136 (formerly referred to as AMG 594), cardiac troponin activator)
- Analyzed data from the completed Phase 1 study of CK-136 conducted by Amgen to inform next steps in its development.
CK-3773274 (CK-274, cardiac myosin inhibitor)
- Progressed REDWOOD-HCM (Randomized Evaluation of Dosing With CK-274 in Obstructive Outflow Disease in HCM), the Phase 2 clinical trial designed to determine the safety and tolerability of CK-274 in patients with obstructive hypertrophic cardiomyopathy (oHCM), to Cohort 2 following the conduct of an interim analysis of data from Cohort 1. In December, we opened Cohort 2 in REDWOOD-HCM to screening and it completed patient enrollment in February.
- The interim analysis of data from Cohort 1 showed that patients experienced substantial reductions in the average resting left ventricular outflow tract gradient (LVOT-G) as well as the post-Valsalva LVOT-G. These clinically relevant decreases in pressure gradients were achieved with only modest decreases in average LVEF; there were no dose interruptions due to LVEF falling below 50%. Pharmacokinetic data were similar to data from Phase 1.
- Safety and tolerability data were supportive of continued dose escalation with no serious adverse events attributed to study treatment reported by the investigators.
- The interim analysis of data from Cohort 1 showed that patients experienced substantial reductions in the average resting left ventricular outflow tract gradient (LVOT-G) as well as the post-Valsalva LVOT-G. These clinically relevant decreases in pressure gradients were achieved with only modest decreases in average LVEF; there were no dose interruptions due to LVEF falling below 50%. Pharmacokinetic data were similar to data from Phase 1.
- Received approval of IND submitted in
China for conduct of a Phase 1 study of CK-274 under the License and Collaboration Agreement betweenCytokinetics andJi Xing Pharmaceuticals Limited . - Presented preclinical data for CK-274 showing that it reduced contractility and left ventricular outflow tract peak pressure gradient in cats with naturally occurring HCM and left ventricular outflow tract obstruction.
CK-3772271 (CK-271, second cardiac myosin inhibitor)
- Presented preclinical data for CK-271 demonstrating that, in the Dahl/Salt sensitive rat model of heart failure with preserved ejection fraction (HFpEF), CK-271 attenuated the development of fibrosis and diastolic dysfunction.
- Completed the planned Phase 1, single-dose pharmacokinetic evaluation and tolerability assessments of CK-271 in healthy volunteers and determined it to be suitable for further development. We are evaluating its potential for further development in connection with plans to conduct a broad development program for our cardiac myosin inhibitor(s) in HCM and other indications.
Skeletal Muscle Program
reldesemtiv (next-generation fast skeletal muscle troponin activator (FSTA))
- Additional data from FORTITUDE-ALS, the Phase 2 clinical trial of reldesemtiv in patients with ALS, were presented showing that the effect of reldesemtiv was more apparent in faster progressing patients, supporting the rationale and design of COURAGE-ALS, the planned Phase 3 clinical trial of reldesemtiv in patients with ALS.
- The design of COURAGE-ALS was also presented, and we conducted readiness activities in preparation for the potential start of the trial.
- Continued to develop new chemical entities and to conduct IND enabling studies with the expectation of our potentially advancing 1-2 potential drug candidates in development.
- Continued research in collaboration with Astellas directed to the discovery of next-generation skeletal muscle activators under a joint research program extended through
March 31, 2021 . - Continued research activities directed to our other muscle biology research programs which we expect to continue in 2021.
Corporate
- Announced we will regain worldwide rights to develop and commercialize omecamtiv mecarbil and CK-136 in
May 2021 . - Named
Nancy Wysenski andMuna Bhanji to the company’s Board of Directors. - Received
$85 million upon the closing of the sale of a royalty on mavacamten, being developed by Bristol-Myers Squibb Company (formerly by MyoKardia, Inc.), toRTW Royalty Holdings Designated Activity Company .
2021 Corporate Milestones
Cardiac Muscle Programs
omecamtiv mecarbil (cardiac myosin activator)
- Plan to meet with FDA to discuss GALACTIC-HF in Q1 2021.
- Expect enrollment in METEORIC-HF to be completed in 1H 2021.
- Develop a “go-to-market” strategy and potential commercial launch plan in 1H 2021.
CK-3773274 (CK-274, cardiac myosin inhibitor)
- Expect a Phase 1 study of CK-274 in
China , conducted under the License and Collaboration Agreement betweenCytokinetics andJi Xing Pharmaceuticals Limited , to start in Q1 2021. - Expect to begin an open label extension study for patients who complete REDWOOD-HCM in Q2 2021.
- Expect to announce results from both cohorts in REDWOOD-HCM by mid-year 2021.
- Plan to engage regulatory authorities regarding a potential registration path in 2H 2021.
- Expect to begin a potential Phase 3 clinical trial of CK-274 by the end of 2021.
Skeletal Muscle Program
reldesemtiv (next-generation fast skeletal muscle troponin activator (FSTA))
- We expect to conduct start-up activities for COURAGE-ALS in 2021 and may open the trial to enrollment in 2H 2021, subject to our plans relating to advancing omecamtiv mecarbil towards commercialization and CK-274 to a potential Phase 3 clinical trial in patients with oHCM.
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
2021 Financial Guidance
The company today announced financial guidance for 2021. The company anticipates revenue will be in the range of
Conference Call and Webcast Information
Members of Cytokinetics’ senior management team will review the company’s fourth quarter 2020 results via a webcast and conference call today at
An archived replay of the webcast will be available via Cytokinetics’ website until
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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”).
Contact:
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(415) 290-7757
Condensed Consolidated Balance Sheets (in thousands) |
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(unaudited) | |||||||
ASSETS | |||||||
Current assets: | |||||||
Cash and short term investments | $ | 464,060 | $ | 225,112 | |||
Other current assets | 10,161 | 8,640 | |||||
Total current assets | 474,221 | 233,752 | |||||
Long-term investments | 36,954 | 42,650 | |||||
Property and equipment, net | 13,346 | 4,530 | |||||
Operating lease right-of-use assets and other assets | 9,282 | 8,882 | |||||
Total assets | $ | 533,803 | $ | 289,814 | |||
LIABILITIES AND STOCKHOLDERS’ EQUITY (DEFICIT) | |||||||
Current liabilities: | |||||||
Accounts payable and accrued liabilities | $ | 27,365 | $ | 20,283 | |||
Short-term lease liability | 2,785 | 4,616 | |||||
Other current liabilities | 1,049 | 1,124 | |||||
Total current liabilities | 31,199 | 26,023 | |||||
Term loan, net | 46,209 | 45,052 | |||||
Convertible notes, net | 89,504 | 84,205 | |||||
Liability related to the sale of future royalties, net | 166,068 | 143,276 | |||||
Long-term deferred revenue | 87,000 | — | |||||
Long-term lease liability | 440 | 2,195 | |||||
Total liabilities | 420,420 | 300,751 | |||||
Commitments and contingencies | |||||||
Stockholders’ equity (deficit): | |||||||
Common stock | 70 | 59 | |||||
Additional paid-in capital | 1,105,470 | 853,341 | |||||
Accumulated other comprehensive income | 149 | 679 | |||||
Accumulated deficit | (992,306 | ) | (865,016 | ) | |||
Total stockholders’ equity (deficit) | 113,383 | (10,937 | ) | ||||
Total liabilities and stockholders’ equity (deficit) | $ | 533,803 | $ | 289,814 |
Condensed Consolidated Statements of Operations (in thousands except per share data) (unaudited) |
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Three Months Ended |
Years Ended |
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2020 | 2019 | 2018 | 2020 | 2019 | 2018 | ||||||||||||||||||
Revenues: | |||||||||||||||||||||||
Research and development revenues | $ | 4,222 | $ | 5,212 | $ | 9,377 | $ | 16,527 | $ | 26,868 | $ | 26,368 | |||||||||||
License revenues | — | — | — | 36,501 | — | 5,133 | |||||||||||||||||
Milestone revenues | 2,500 | — | — | 2,800 | — | — | |||||||||||||||||
Total revenues | 6,722 | 5,212 | 9,377 | 55,828 | 26,868 | 31,501 | |||||||||||||||||
Operating expenses: | |||||||||||||||||||||||
Research and development | 29,221 | 18,334 | 23,278 | 96,951 | 86,125 | 89,135 | |||||||||||||||||
General and administrative | 13,908 | 10,584 | 7,558 | 52,820 | 39,610 | 31,282 | |||||||||||||||||
Total operating expenses | 43,129 | 28,918 | 30,836 | 149,771 | 125,735 | 120,417 | |||||||||||||||||
Operating loss | (36,407 | ) | (23,706 | ) | (21,459 | ) | (93,943 | ) | (98,867 | ) | (88,916 | ) | |||||||||||
Interest expense | (4,018 | ) | (2,731 | ) | (1,170 | ) | (15,963 | ) | (6,623 | ) | (3,797 | ) | |||||||||||
Non-cash interest expense on liability related to sale of future royalties | (5,651 | ) | (5,533 | ) | (4,740 | ) | (22,713 | ) | (20,737 | ) | (17,767 | ) | |||||||||||
Interest and other income, net | 2,146 | 1,330 | 900 | 5,329 | 4,535 | 4,191 | |||||||||||||||||
Net loss before income taxes | (43,930 | ) | (30,640 | ) | (26,469 | ) | (127,290 | ) | (121,692 | ) | (106,289 | ) | |||||||||||
Income tax benefit | — | — | — | — | — | — | |||||||||||||||||
Net loss | $ | (43,930 | ) | $ | (30,640 | ) | $ | (26,469 | ) | $ | (127,290 | ) | $ | (121,692 | ) | $ | (106,289 | ) | |||||
Net loss per share — basic and diluted | $ | (0.62 | ) | $ | (0.52 | ) | $ | (0.48 | ) | $ | (1.97 | ) | $ | (2.11 | ) | $ | (1.95 | ) | |||||
Weighted-average shares in net loss per share — basic and diluted | 70,833 | 59,133 | 54,689 | 64,524 | 57,575 | 54,420 |
Source: Cytokinetics, Incorporated