Cytokinetics Reports First Quarter 2021 Financial Results
Secondary Analysis from GALACTIC-HF to be Presented in Late Breaking Clinical Trial Session at ACC.21
Company Plans to Submit NDA for Omecamtiv Mecarbil following Recent Meeting with FDA
Results from REDWOOD-HCM Expected Mid-Year; Open Label Extension Study and Phase 3 Clinical Trial Planning Underway
“We continued to execute well in the first quarter against our ambitious plans. We recently convened a meeting with FDA related to omecamtiv mecarbil and GALACTIC-HF and are proceeding towards additional planned meetings this quarter with an expected NDA submission in the second half of the year,” said
Q1 and Recent Highlights
Cardiac Muscle Programs
omecamtiv mecarbil (cardiac myosin activator)
- Met with the
U.S. Food and Drug Administration (FDA) in Q1 and anticipate additional regulatory interactions in Q2 to inform plans to submit a New Drug Application (NDA) for omecamtiv mecarbil in 2H 2021. The planned regulatory filing is expected to be based on a single pivotal trial, 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 - Announced that data from a secondary analysis of GALACTIC-HF (Global Approach to Lowering Adverse Cardiac Outcomes Through Improving Contractility in Heart Failure) assessing the effect of omecamtiv mecarbil on clinical outcomes in relationship to patient baseline ejection fraction will be presented in a Late Breaking Clinical Trial session at the
American College of Cardiology 70th AnnualScientific Session & Expo (ACC.21). - 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. Expect to complete enrollment in Q2 and report results in early 2022.
- Conducted market research, forecasting and other planning activities in support of the potential commercialization of omecamtiv mecarbil.
- Published a manuscript entitled, “Effect of Varying Degrees of Renal Impairment on the Pharmacokinetics of Omecamtiv Mecarbil” in Clinical Pharmacokinetics.
CK-3773274 (CK-274, cardiac myosin inhibitor)
- Dosed the first patient in Cohort 2 of 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). We subsequently completed enrollment in Cohort 2 of REDWOOD-HCM in Q1.
- Opened enrollment in Cohort 3 of REDWOOD-HCM for patients whose background therapy includes disopyramide.
- Activated the first site for enrollment in REDWOOD-HCM OLE, the open label extension clinical study designed to assess the long-term safety and tolerability of CK-274 in patients with symptomatic oHCM who have participated previously in REDWOOD-HCM.
- Received orphan drug designation for CK-274 for the potential treatment of symptomatic HCM from the FDA.
- Prepared for regulatory interactions with FDA to occur in Q2 and continuing into the second half of 2021 to inform preparations for a pivotal Phase 3 clinical trial of CK-274 in HCM, expected to begin by year-end.
- Recently presented data related to the optimization of CK-274, including the first disclosure of its chemical structure, at the
American Chemical Society Spring 2021 Virtual Meeting. - Enrolled the first patient in a Phase 1 study of CK-274 in
China under the License and Collaboration Agreement betweenCytokinetics andJi Xing Pharmaceuticals Limited .
Skeletal Muscle Program
reldesemtiv (next-generation fast skeletal muscle troponin activator (FSTA))
- Conducted start-up activities, including regulatory and institutional review board submissions, for COURAGE-ALS (Clinical Outcomes Using Reldesemtiv on ALSFRS-R in a Global Evaluation in ALS), the planned Phase 3 clinical trial of reldesemtiv in patients with ALS, in preparation for the potential opening of the trial to patient enrollment in 2H 2021.
- Completed joint research program under collaboration with Astellas directed to the discovery of next-generation skeletal muscle activators.
- Published a manuscript entitled “Reldesemtiv in Patients with Spinal Muscular Atrophy: A Phase 2 Hypothesis-Generating Study” in Neurotherapeutics.
- Continued to advance new chemical entities and to conduct IND-enabling studies with expectation of our potentially advancing 1-2 potential drug candidates in development over the next year.
- Continued research activities directed to our other muscle biology research programs.
Corporate
- Conducted planning activities related to the termination of the Collaboration and Option Agreement with Amgen and the transition of rights to develop and commercialize omecamtiv mecarbil, effective
May 20, 2021 . - Joined with the
European Organisation for Rare Diseases (EURORDIS) and theNational Organization for Rare Disorders (NORD) to recognize Rare Disease Day®, an international campaign elevating the public understanding of rare diseases. - Awarded Cytokinetics Communications Fellowship Grants to patient advocacy organizations serving the heart failure, HCM, ALS and SMA communities to support increased capacity in communications, disease awareness and community engagement.
- Convened inaugural
Heart Failure Advisory Council meeting with patients and caregivers with heart failure to inform the ongoing development of the company’s heart failure directed pipeline.
Financials
Revenues for the first quarter 2021 increased to
Research and development expenses for the first quarter 2021 increased to
General and administrative expenses for the first quarter of 2021 increased to
We expect to revise our financial guidance mid-year once we finalize strategies and potential commercial launch plans for omecamtiv mecarbil. Executing on those strategies and plans may result in our incurring significant additional expenses that were not included in our current financial guidance. We expect that some or all of those potential expenses could be covered by our accessing additional capital through strategic partnership(s) with near term cash infusions or by equity and/or debt financings if deemed appropriate.
Conference Call and Webcast Information
Members of Cytokinetics’ senior management team will review the company’s first quarter 2021 results via a webcast and conference call today at
An archived replay of the webcast will be available via Cytokinetics’ website until
About
For additional information about
Forward-Looking Statements
This press release contains forward-looking statements for purposes of the Private Securities Litigation Reform Act of 1995 (the “Act”).
Contact:
Senior Vice President, Corporate Communications, Investor Relations
(415) 290-7757
Condensed Consolidated Balance Sheets (in thousands) |
||||||||
| (unaudited) | ||||||||
| ASSETS | ||||||||
| Current assets: | ||||||||
| Cash and short term investments | $ | 425,577 | $ | 464,060 | ||||
| Other current assets | 7,540 | 10,161 | ||||||
| Total current assets | 433,117 | 474,221 | ||||||
| Long-term investments | 34,664 | 36,954 | ||||||
| Property and equipment, net | 23,198 | 13,346 | ||||||
| Operating lease right-of-use assets and other assets | 86,083 | 9,282 | ||||||
| Total assets | $ | 577,062 | $ | 533,803 | ||||
| LIABILITIES AND STOCKHOLDERS’ EQUITY (DEFICIT) | ||||||||
| Current liabilities: | ||||||||
| Accounts payable and accrued liabilities | $ | 22,572 | $ | 27,365 | ||||
| Current portion of long-term debt | 5,625 | — | ||||||
| Short-term lease liabilities | 5,295 | 2,785 | ||||||
| Other current liabilities | 2,438 | 1,049 | ||||||
| Total current liabilities | 35,930 | 31,199 | ||||||
| Term loan, net | 40,874 | 46,209 | ||||||
| Convertible notes, net | 90,889 | 89,504 | ||||||
| Liability related to the sale of future royalties, net | 168,890 | 166,068 | ||||||
| Long-term deferred revenue | 87,000 | 87,000 | ||||||
| Long-term lease liability | 85,633 | 440 | ||||||
| Total liabilities | 509,216 | 420,420 | ||||||
| Commitments and contingencies | ||||||||
| Stockholders’ equity (deficit): | ||||||||
| Common stock | 71 | 70 | ||||||
| Additional paid-in capital | 1,107,135 | 1,105,470 | ||||||
| Accumulated other comprehensive income | 50 | 149 | ||||||
| Accumulated deficit | (1,039,410 | ) | (992,306 | ) | ||||
| Total stockholders’ equity (deficit) | 67,846 | 113,383 | ||||||
| Total liabilities and stockholders’ equity (deficit) | $ | 577,062 | $ | 533,803 | ||||
Condensed Consolidated Statements of Operations (in thousands except per share data) (unaudited) |
||||||||
| Three Months Ended | ||||||||
| Revenues: | ||||||||
| Research and development revenues | $ | 6,548 | $ | 3,825 | ||||
| Total revenues | 6,548 | 3,825 | ||||||
| Operating expenses: | ||||||||
| Research and development | 31,561 | 21,738 | ||||||
| General and administrative | 15,598 | 12,449 | ||||||
| Total operating expenses | 47,159 | 34,187 | ||||||
| Operating loss | (40,611 | ) | (30,362 | ) | ||||
| Interest expense | (3,988 | ) | (4,077 | ) | ||||
| Non-cash interest expense on liability related to the sale of future royalties | (2,795 | ) | (5,689 | ) | ||||
| Interest and other income | 290 | 723 | ||||||
| Net loss | $ | (47,104 | ) | $ | (39,405 | ) | ||
| Net loss per share — basic and diluted | $ | (0.66 | ) | $ | (0.66 | ) | ||
| Weighted-average number of shares used in computing net loss per share — basic and diluted | 71,195 | 59,270 | ||||||
Source: Cytokinetics, Incorporated