Cytokinetics Reports Second Quarter 2021 Financial Results
Submission of NDA for Omecamtiv Mecarbil on Track to Occur in 2H 2021
Positive Results from REDWOOD-HCM Support Progression of Aficamten (CK-274) to Pivotal Phase 3 Trial in Patients with Obstructive Hypertrophic Cardiomyopathy Expected to Start in Q4
Pivotal Phase 3 Trial of Reldesemtiv in Patients with ALS Now Enrolling
More than Three Years of Cash Runway Following Recent Financing and Updated 2021 Guidance
“During the second quarter, we made progress in advancing our late-stage muscle biology-directed pipeline and are now preparing for our first NDA submission while two other programs are expected to proceed in pivotal Phase 3 trials this year,” said
Q2 and Recent Highlights
Cardiac Muscle Programs
omecamtiv mecarbil (cardiac myosin activator)
- Engaged with the
U.S. Food and Drug Administration (FDA) in both a Type C meeting and a pre-NDA meeting to inform our plans to submit a New Drug Application (NDA) for omecamtiv mecarbil in 2H 2021. The submission will be based on GALACTIC-HF which demonstrated a positive effect on the primary composite endpoint of cardiovascular death or heart failure events in patients with heart failure and reduced ejection fractionwho were receiving standard of care plus omecamtiv mecarbil. - Results from a secondary analysis of GALACTIC-HF (Global Approach to Lowering Adverse Cardiac Outcomes Through Improving Contractility in Heart Failure) were presented at the
American College of Cardiology 70th AnnualScientific Session & Expo (ACC.21) showing that the treatment effect of omecamtiv mecarbil increased progressively as baseline ejection fraction decreased. The results were also published in theJournal of the American College of Cardiology . - Additional results from GALACTIC-HF were presented at Heart Failure 2021, an
International Congress of theEuropean Society of Cardiology demonstrating that the patientswho derived greater treatment benefit from omecamtiv mecarbil included patients without atrial fibrillation or flutter, patients with higher baseline NT-proBNP and patients with severe heart failure based on modified criteria from theHeart Failure Association of theEuropean Society of Cardiology (ESC-HFA) advanced heart failure position statement. - Completed enrollment in METEORIC-HF (Multicenter Exercise Tolerance Evaluation of Omecamtiv Mecarbil Related to Increased Contractility in Heart Failure), the second Phase 3 trial of omecamtiv mecarbil. We expect to complete conduct of METEORIC-HF by year end and report results in early 2022.
- Expanded Medical Affairs team and activities. Hired medical directors and deployed Medical Science Liaisons in key
U.S. locations. Organized framework for the Investigator Sponsored Study Program. - Established Go-to-Market-strategy and conducted commercial readiness activities, including organizational design, market research, forecasting, market access preparations and supply chain and logistics planning.
aficamten (CK-3773274, cardiac myosin inhibitor)
- Received approval from the
World Health Organization and theUnited States Adopted Name Council for aficamten to be used as the International Nonproprietary Name for CK-3773274. - Announced positive topline results from Cohorts 1 and 2 of REDWOOD-HCM (Randomized Evaluation of Dosing With CK-274 in Obstructive Outflow Disease in HCM) demonstrating that treatment with aficamten for 10 weeks resulted in statistically significant reductions from baseline compared to placebo in the average resting left ventricular outflow tract pressure gradient (LVOT-G) (p=0.0003, p=0.0004, Cohort 1 and Cohort 2, respectively) and the average post-Valsalva LVOT-G (p=0.001, p<0.0001, Cohort 1 and Cohort 2, respectively). The majority of patients treated with aficamten (78.6% in Cohort 1 and 92.9% in Cohort 2) achieved the target goal of treatment, defined as resting gradient <30 mmHg and post-Valsalva gradient <50 mmHg at Week 10 compared to placebo (7.7%). Treatment with aficamten in REDWOOD-HCM was generally well tolerated. The incidence of adverse events was similar between treatment arms. No serious adverse events were attributed to aficamten and no treatment interruptions occurred on aficamten, and no new cases of atrial fibrillation in patients treated with aficamten were reported.
- 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 aficamten in patients with symptomatic obstructive HCM
who have participated previously in REDWOOD-HCM. - Engaged FDA in a Type C meeting and subsequent end-of Phase 2 interaction to review the design of the planned Phase 3 clinical trial of aficamten in patients with obstructive HCM as well as the intended dosing strategy. Feedback was supportive of our objectives and progression.
- Conducted preparations for a pivotal Phase 3 clinical trial of aficamten in patients with obstructive HCM, expected to begin in Q4 2021.
Ji Xing Pharmaceuticals continued enrolling patients in a Phase 1 study of aficamten inChina and is preparing to participate in the planned Phase 3 clinical trial of aficamten in patients with obstructive HCM.- Presented scientific data related to the optimization of aficamten, including the first disclosure of its chemical structure, at the
American Chemical Society Spring 2021 Virtual Meeting.
Skeletal Muscle Program
reldesemtiv (next-generation fast skeletal muscle troponin activator (FSTA))
- Recently started COURAGE-ALS (Clinical Outcomes Using Reldesemtiv on ALSFRS-R in a Global Evaluation in ALS), the planned pivotal Phase 3 clinical trial of reldesemtiv in patients with ALS.
- Continued to advance new chemical entities and to conduct IND-enabling studies with expectation of our potentially advancing 1-2 potential drug candidates into clinical development over the next year.
- Continued research activities directed to our other muscle biology research programs.
Corporate
- Raised approximately
$297.3 million in net proceeds, after deducting underwriting discounts and commissions from an underwritten public offering of 11,500,000 shares of common stock including the underwriter’s exercise of their overallotment option. - Executed agreements related to the termination of our Collaboration Agreement with Amgen and the transition to
Cytokinetics of the development and commercialization rights for omecamtiv mecarbil and CK-136. - Announced the continuation of our partnership with
The ALS Association in the fight against ALS.
Financials
Revenues for the three and six months ended
Research and development expenses for the three and six months ended
General and administrative expenses for the three and six months ended
Financial Guidance and Cash Runway
The company recently updated its financial guidance for 2021. We expect our revenues for 2021 will be in the range of
The company ended the second quarter with
Conference Call and Webcast Information
Members of Cytokinetics’ senior management team will review the company’s second quarter results via a webcast and conference call today at 4:30 PM Eastern Time. The webcast can be accessed through the Investors & Media section of Cytokinetics’ website at www.cytokinetics.com. The live audio of the conference call can also be accessed by telephone by dialing either (866) 999-CYTK (2985) (
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 | $ | 350,301 | $ | 464,060 | ||||
Other current assets | 13,928 | 10,161 | ||||||
Total current assets | 364,229 | 474,221 | ||||||
Long-term investments | 73,672 | 36,954 | ||||||
Property and equipment, net | 36,942 | 13,346 | ||||||
Operating lease right-of-use assets | 83,006 | 2,924 | ||||||
Other assets | 6,453 | 6,358 | ||||||
Total assets | $ | 564,302 | $ | 533,803 | ||||
LIABILITIES AND STOCKHOLDERS’ EQUITY (DEFICIT) | ||||||||
Current liabilities: | ||||||||
Accounts payable and accrued liabilities | $ | 37,322 | $ | 27,365 | ||||
Current portion of long-term debt | 11,250 | — | ||||||
Short-term lease liabilities | 12,190 | 2,785 | ||||||
Other current liabilities | 1,004 | 1,049 | ||||||
Total current liabilities | 61,766 | 31,199 | ||||||
Term loan, net | 35,538 | 46,209 | ||||||
Convertible notes, net | 92,348 | 89,504 | ||||||
Liability related to the sale of future royalties, net | 171,790 | 166,068 | ||||||
Long-term deferred revenue | 87,000 | 87,000 | ||||||
Long-term lease liability | 99,371 | 440 | ||||||
Total liabilities | 547,813 | 420,420 | ||||||
Commitments and contingencies | ||||||||
Stockholders’ equity (deficit): | ||||||||
Common stock | 72 | 70 | ||||||
Additional paid-in capital | 1,117,403 | 1,105,470 | ||||||
Accumulated other comprehensive income | (22 | ) | 149 | |||||
Accumulated deficit | (1,100,964 | ) | (992,306 | ) | ||||
Total stockholders’ equity (deficit) | 16,489 | 113,383 | ||||||
Total liabilities and stockholders’ equity (deficit) | $ | 564,302 | $ | 533,803 | ||||
Condensed Consolidated Statements of Operations | ||||||||||||||||||
(in thousands except per share data) | ||||||||||||||||||
(unaudited) | ||||||||||||||||||
Three Months Ended | Six Months Ended | |||||||||||||||||
Revenues: | ||||||||||||||||||
Research and development revenues | $ | 2,843 | $ | 3,593 | $ | 9,391 | $ | 7,418 | ||||||||||
Total revenues | 2,843 | 3,593 | 9,391 | 7,418 | ||||||||||||||
Operating expenses: | ||||||||||||||||||
Research and development | 36,443 | 21,790 | 68,004 | 43,528 | ||||||||||||||
General and administrative | 21,197 | 14,161 | 36,795 | 26,610 | ||||||||||||||
Total operating expenses | 57,640 | 35,951 | 104,799 | 70,138 | ||||||||||||||
Operating loss | (54,797 | ) | (32,358 | ) | (95,408 | ) | (62,720 | ) | ||||||||||
Interest expense | (4,073 | ) | (3,892 | ) | (8,061 | ) | (7,969 | ) | ||||||||||
Non-cash interest expense on liability related to the sale of future royalties | (2,871 | ) | (5,912 | ) | (5,666 | ) | (11,601 | ) | ||||||||||
Interest and other income | 187 | 1,382 | 477 | 2,105 | ||||||||||||||
Net loss | $ | (61,554 | ) | $ | (40,780 | ) | $ | (108,658 | ) | $ | (80,185 | ) | ||||||
Net loss per share — basic and diluted | $ | (0.86 | ) | $ | (0.68 | ) | $ | (1.52 | ) | $ | (1.35 | ) | ||||||
Weighted-average number of shares used in computing net loss per share — basic and diluted | 71,754 | 59,605 | 71,476 | 59,438 | ||||||||||||||
Source: Cytokinetics, Incorporated