Cytokinetics Reports Second Quarter 2020 Financial Results
Top-line Results from GALACTIC-HF Expected in Q4 2020
to Support Commercial Development and Pipeline Expansion;
Company Expects to End 2020 With More Than
After the quarter,
“Despite challenges related to the COVID-19 pandemic,
Cardiac Muscle Programs
omecamtiv mecarbil (cardiac myosin activator)
- Received Fast Track designation for omecamtiv mecarbil for the potential treatment of chronic heart failure with reduced ejection fraction (HFrEF).
- Continued conduct of and initiated closeout activities for 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. We expect top-line results in Q4 2020. GALACTIC-HF is being conducted by Amgen in collaboration with
- 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. After suspending enrollment in METEORIC-HF due to the COVID-19 pandemic earlier this year, we resumed enrollment in June. We expect enrollment to be completed in early 2021. METEORIC-HF is being conducted by
Cytokineticsin collaboration with Amgen.
- Collaborated with Amgen and
Servieron preparations for a potential Marketing Application dossier for omecamtiv mecarbil and prepared for possible meetings with regulatory authorities as may be requested to discuss Phase 3 trial results and potential Marketing Applications.
- Continued to conduct commercial readiness activities in collaboration with Amgen, in preparation for the commercialization of omecamtiv mecarbil, including market research related to product branding elements, potential positioning, physician preferences and potential customer accounts.
- Continued joint disease state education with Amgen to educate the heart failure community on the unmet needs of heart failure patients and the role of cardiac contractility related to cardiac performance in HFrEF.
- Collaborated with providers and healthcare systems to generate health economics and outcomes research related to the healthcare costs associated with the treatment of heart failure patients.
- Conducted analyses related to
the United Statesheart failure institutional care market segment, including potential target account assessment and prioritization for planned commercialization.
AMG 594 (cardiac troponin activator)
- The Phase 1 study of AMG 594 is now complete with data analyses ongoing. Amgen and
Cytokineticsare discussing potential next steps in the development program.
- Conducted market research relating to potential indications to inform Phase 2 trial planning.
CK-3773274 (CK-274, cardiac myosin inhibitor)
- Continued conduct 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 (HCM). After suspending enrollment in REDWOOD-HCM due to the COVID-19 pandemic earlier this year, we resumed enrollment in June. We expect data from the first cohort of patients in REDWOOD-HCM, which will inform progression of the trial to the second cohort, to be available by the end of 2020.
CK-271 (CK-271, second cardiac myosin inhibitor)
- Prepared for the start of a Phase 1 study of CK-271 which is expected to begin in Q3 2020.
Skeletal Muscle Program
reldesemtiv (next-generation fast skeletal muscle troponin activator (FSTA))
- Obtained advice from the
European Medicines Agency(EMA) through Protocol Assistance related to the design of a potential Phase 3 clinical trial of reldesemtiv in patients with ALS.
- Convened meetings with clinical experts, ALS patient advocates and health technology assessment organizations to obtain feedback on endpoints and other matters relating to the design of the trial.
- Continued pre-clinical development of CK-3762601 (CK-601), a next-generation FSTA. We expect to continue the conduct of IND-enabling studies of CK-601 in 2020.
- Continued research in collaboration with Astellas directed to the discovery of next-generation skeletal muscle activators.
- Continued independent research activities directed to our other muscle biology research programs.
- Participated in the launch of
Kainomyx, Inc., a new biopharmaceutical company focused on the discovery and development of small molecule therapeutics for the treatment of parasitic diseases.
- Executed a series of transactions in July with
RTW Investments, LP, and Ji Xing Pharmaceuticals Limitedrelated to CK-274 whereby Cytokineticswill receive a combination of committed capital, funding and sale proceeds of up to $250 millionand is eligible to receive up to $200 millionin milestone payments plus royalties on future sales of CK-274 in certain Asian countries.
$189 millionin net proceeds, after deducting underwriting discounts and commissions, from an underwritten public offering in July of 8,385,417 shares of common stock including the underwriter’s exercise of their overallotment option.
- Amended our agreement with Astellas, whereby
Cytokineticsobtained exclusive rights for the development and commercialization of reldesemtiv, CK-601 and other fast skeletal regulatory activator (FSRA) compounds. Astellas agreed to pay for certain costs associated with the conduct of a potential Phase 3 clinical trial of reldesemtiv in ALS in exchange for a low- to mid-single digit royalty on sales of reldesemtiv in ALS. Astellas and Cytokineticsalso extended the joint research program through 2020.
- Announced the continuation of our partnership with The ALS Association in the fight against ALS.
- Supported the Patient Focused Drug Development Meeting hosted by the HCMA to shed light on the burden of disease and challenges faced by patients with HCM.
Revenues for the three and six months ended
Research and development expenses for the three and six months ended
General and administrative expenses for the three and six months ended
The company also updated financial guidance for 2020. The company still anticipates cash revenue will be in the range of
Conference Call and Webcast Information
Members of Cytokinetics’ senior management team will review the company’s second quarter 2020 results via a webcast and conference call today at
An archived replay of the webcast will be available via Cytokinetics’ website until
This press release contains forward-looking statements for purposes of the Private Securities Litigation Reform Act of 1995 (the “Act”).
Senior Vice President, Corporate Communications, Investor Relations
|Condensed Consolidated Balance Sheets|
|Cash and short term investments||$||213,063||$||225,112|
|Other current assets||5,891||8,640|
|Total current assets||218,954||233,752|
|Property and equipment, net||5,611||4,530|
|Operating lease right-of-use assets and other assets||7,930||8,882|
|LIABILITIES AND STOCKHOLDERS’ DEFICIT|
|Accounts payable and accrued liabilities||$||16,608||$||20,283|
|Short-term lease liability||5,075||4,616|
|Other current liabilities||1,013||1,124|
|Total current liabilities||22,696||26,023|
|Term loan, net||45,631||45,052|
|Convertible notes, net||86,743||84,205|
|Liability related to the sale of future royalties, net||154,914||143,276|
|Long-term lease liability||591||2,195|
|Commitments and contingencies|
|Additional paid-in capital||865,724||853,341|
|Accumulated other comprehensive income||1,337||679|
|Total stockholders’ deficit||(78,080||)||(10,937||)|
|Total liabilities and stockholders’ deficit||$||232,495||$||289,814|
|Condensed Consolidated Statements of Operations|
|(in thousands except per share data)|
|Three Months Ended||Six Months Ended|
|Research and development revenues||$||3,593||$||7,137||$||7,418||$||15,601|
|Research and development||21,790||24,017||43,528||47,562|
|General and administrative||14,161||9,836||26,610||19,273|
|Total operating expenses||35,951||33,853||70,138||66,835|
|Non-cash interest expense on liability related to the sale of future royalties||(5,912||)||(5,064||)||(11,601||)||(9,883||)|
|Interest and other income||1,382||1,044||2,105||2,185|
|Net loss per share — basic and diluted||$||(0.68||)||$||(0.56||)||$||(1.35||)||$||(1.09||)|
|Weighted-average number of shares used in computing net loss per share — basic and diluted||59,605||57,648||59,438||56,242|
Source: Cytokinetics, Incorporated