Cytokinetics, Inc. Reports Second Quarter 2018 Financial Results
Phase 2 Study of Reldesemtiv in Patients with SMA
Showed Potentially Clinically Meaningful Effects
on Six Minute Walk Distance and Maximal Expiratory Pressure
Results from Phase 2 Clinical Trial of Reldesemtiv in Patients with COPD Expected in Q3
Finalizing Preparations to Initiate Second Phase 3 Clinical Trial of Omecamtiv Mecarbil
“We made substantial progress in the second quarter of 2018 advancing programs in both our cardiac and skeletal muscle verticals,” said
Recent Highlights and Upcoming Milestones
Cardiac Muscle Program
omecamtiv mecarbil (cardiac myosin activator)
- Continued patient enrollment in GALACTIC-HF (Global Approach to Lowering Adverse Cardiac Outcomes Through Improving Contractility in Heart Failure), the Phase 3 cardiovascular outcomes clinical trial of omecamtiv mecarbil. Enrollment has surpassed 50 percent completion with over 4,000 patients randomized to date having a risk profile consistent with the trial design. We expect completion of patient enrollment into GALACTIC-HF to occur during the first half of 2019.
- Conducted further interactions with
FDAand finalized the protocol for a second Phase 3 clinical trial of omecamtiv mecarbil. This trial is intended to evaluate the potential effect of omecamtiv mecarbil on exercise performance in patients with heart failure and will be conducted by Cytokineticsin collaboration with Amgen. We continue to work toward the objective of beginning this clinical trial by the end of the year.
Skeletal Muscle Program
reldesemtiv (next-generation FSTA)
- Announced that data from the Phase 2 clinical study of reldesemtiv in patients with spinal muscular atrophy (SMA) were presented by
John W. Day, M.D., Ph.D., Professor of Neurology and Pediatrics (Genetics), Stanford University, at the 2018 Annual Cure SMA Conferencein Dallas. The study showed dose- and concentration-dependent increases in time to muscle fatigue as measured by changes from baseline in Six Minute Walk Distance, a sub-maximal exercise test of aerobic capacity and endurance, and Maximal Expiratory Pressure, a measure of strength of respiratory muscles, after eight weeks of treatment with reldesemtiv.
- Continued site activation and patient enrollment in 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 which is designed to assess the change from baseline in percent predicted slow vital capacity and other measures of skeletal muscle function after 12 weeks of treatment with reldesemtiv in patients with ALS. This trial has enrolled over 250 patients toward the objective of 445 patients in the trial and is being conducted by
Cytokineticsin collaboration with Astellas. We expect to complete enrollment in FORTITUDE-ALS in Q4 2018 with results from this clinical trial now expected in the first half of 2019.
- Completed patient enrollment in the Phase 2 clinical trial of reldesemtiv in patients with chronic obstructive pulmonary disease (COPD) which is designed to assess its effect on physical function. This trial is being conducted by Astellas in collaboration with
Cytokinetics. We expect results from this clinical trial in Q3 2018.
- Continued patient enrollment in the Phase 1b clinical trial of reldesemtiv in elderly subjects with limited mobility which is designed to assess its effect on measures of physical function. This trial is being conducted by Astellas in collaboration with
Cytokinetics. We expect Astellas will conduct an interim analysis of data from this clinical trial in Q3 2018.
- Continued research in collaboration with Astellas directed to the discovery of next-generation skeletal muscle activators; jointly advanced a potential drug candidate into IND-enabling studies.
- Continued pre-clinical development of a next-generation cardiac muscle activator in collaboration with
Amgen; we expect to submit an IND in 2018 and plan to initiate Phase 1 studies for this potential drug candidate by year-end or in early 2019.
- Continued IND-enabling studies with an unpartnered cardiac sarcomere directed compound and engaged
FDAin preparation for potential advancement to Phase 1 studies expected in Q4 2018.
- Continued independent research activities directed to our other muscle biology research programs.
- Announced the continuation of our partnership with
The ALS Associationin the fight against ALS with renewal of Gold Level Sponsorship of the National Walks to Defeat ALS® and Premier Level National ALS Advocacy Conference Sponsorship as well as Platinum Level Sponsorship for initiatives led by The ALS Association Golden West Chapter, including grant funding for care services for people living with ALS in the San Francisco Bay Area.
- Announced an expanded partnership with Cure SMA to increase education, awareness and fundraising for SMA. As a National Platinum Partner for 2018,
Cytokineticswill lend support to several of Cure SMA’s initiatives at both the local and national level to advance understanding of, and research toward potential treatments for SMA.
Revenues for the three and six months ended
Research and development expenses for the three months ended
General and administrative expenses for the three months ended
The Company also updated financial guidance for 2018. The Company has reduced spending and revenue guidance by
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
An archived replay of the webcast will be available via Cytokinetics’ website until
This press release contains forward-looking statements for purposes of the Private Securities Litigation Reform Act of 1995 (the “Act”).
Vice President, Corporate Communications, Investor Relations
Condensed Consolidated Statements of Operations
(in thousands, except per share data, unaudited)
|Three Months Ended||Six Months Ended|
|June 30, 2018||June 30, 2017||June 30, 2018||June 30, 2017|
|Research and development, milestone, grant and other revenues, net||$||4,680||$||(1,889||)||$||8,265||$||818|
|Research and development||21,582||19,809||43,717||39,098|
|General and administrative||8,046||8,438||17,310||16,553|
|Total operating expenses||29,628||28,247||61,027||55,651|
|Non-cash interest expense on liability related to sale of future royalties||(4,338||)||(3,717||)||(8,467||)||(6,012||)|
|Interest and other income, net||1,126||612||1,968||1,049|
|Net loss per share - basic and diluted||$||(0.51||)||$||(0.60||)||$||(1.07||)||$||(1.22||)|
|Weighted-average shares in net loss per share — basic and diluted||54,293||48,218||54,178||44,910|
|Other comprehensive income (loss):|
|Unrealized gain (loss) on available-for-sale securities, net - UPDATE||107||(78||)||107||(223||)|
Condensed Consolidated Balance Sheets
|June 30, 2018||December 31, 2017(1)|
|Cash and short term investments||$||231,941||$||268,891|
|Other current assets||12,288||5,404|
|Total current assets||244,229||274,295|
|Property and equipment, net||2,598||3,568|
|LIABILITIES AND STOCKHOLDERS’ EQUITY|
|Accounts payable and accrued liabilities||$||17,426||$||22,645|
|Deferred revenue, current||—||9,572|
|Current portion of long-term debt||1,703||—|
|Other current liabilities||8,159||227|
|Total current liabilities||27,288||32,444|
|Long-term debt, net||30,662||31,777|
|Liability related to the sale of future royalties, net||113,144||104,650|
|Deferred revenue, non-current||—||15,000|
|Other long-term liabilities||974||1,097|
|Additional paid-in capital||762,887||755,526|
|Accumulated other comprehensive income||450||343|
|Total stockholders’ equity||75,170||109,842|
|Total liabilities and stockholders’ equity||$||247,238||$||294,810|
(1) Derived from the audited financial statements included in the Company’s Annual Report on Form 10-K for the year ended
Source: Cytokinetics, Incorporated