UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
_____________________

Form 8-K
_____________________

CURRENT REPORT

Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934

Date of Report (Date of earliest event Reported): May 9, 2019  

Cytokinetics, Incorporated
(Exact Name of Registrant as Specified in Charter)

Delaware000-5063394-3291317
(State or Other Jurisdiction of Incorporation)(Commission File Number)(I.R.S. Employer Identification Number)

 

280 East Grand Avenue, South San Francisco, California 94080
(Address of Principal Executive Offices) (Zip Code)

(650) 624-3000
(Registrant's telephone number, including area code)

Not Applicable
(Former name or former address, if changed since last report)

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:

 [   ]  Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
 [   ]  Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
 [   ]  Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
 [   ]  Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

 

Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (17 CFR §230.405) or Rule 12b-2 of the Securities Exchange Act of 1934 (17 CFR §240.12b-2). Emerging growth company [   ]

 

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. [   ]

 

Securities registered pursuant to Section 12(b) of the Act:

 

Title of each classTrading Symbol(s)Name of each exchange on which registered
Common Stock, $0.001 par valueCYTKThe Nasdaq Global Select Market

 

 
 

Item 2.02. Results of Operations and Financial Condition.

On May 9, 2019, Cytokinetics, Incorporated issued a press release announcing its results for the first quarter ended March 31, 2019. A copy of the press release is being filed as Exhibit 99.1 to this Current Report and is hereby incorporated by reference into this item 2.02.

Item 9.01. Financial Statements and Exhibits.

Exhibit 99.1. Press release dated May 9, 2019


SIGNATURE

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.

 Cytokinetics, Incorporated
   
  
Date: May 9, 2019By: /s/ Peter S. Roddy        
  Peter S. Roddy
  Senior Vice President, Chief Accounting Officer
  

EdgarFiling

EXHIBIT 99.1

Cytokinetics Reports First Quarter 2019 Financial Results

GALACTIC-HF Continues Following Interim Analysis for Futility; 
METEORIC-HF Opened to Enrollment

Phase 1 Data for CK-274 Expected in Q3 2019;
Planning Underway for Potential Progression to Phase 2

FORTITUDE-ALS Demonstrates Patients on All Doses of Reldesemtiv Declined Less Than Patients on Placebo for SVC and ALSFRS-R, With Clinically Meaningful Differences Emerging Over Time

SOUTH SAN FRANCISCO, Calif., May 09, 2019 (GLOBE NEWSWIRE) -- Cytokinetics, Incorporated (Nasdaq: CYTK) reported financial results for the first quarter of 2019. Net loss for the first quarter was $29.4 million, or $0.54 per share, compared to net loss for the first quarter of 2018 of $30.3 million, or $0.56 per share. Cash, cash equivalents and investments totaled $176.6 million at March 31, 2019.

“We are pleased with the progress made across our pipeline of muscle-directed investigational medicines during the first quarter of 2019,” said Robert I. Blum, Cytokinetics’ President and Chief Executive Officer. “Recently, we shared encouraging data from FORTITUDE-ALS demonstrating consistency of effect for doses, endpoints and timepoints in patients treated with reldesemtiv and we believe the results may support progression to further clinical trials toward potential registration. We also passed through the first planned interim analysis of GALACTIC-HF and opened enrollment in METEORIC-HF while we also independently continued the conduct of the Phase 1 study of CK-274 and prepared for potential progression to Phase 2. Our strategy to advance multiple drug candidates, under our collaborations and independently, continues to generate upside potential for patients and shareholders.”

Recent Highlights

Cardiac Muscle Programs

omecamtiv mecarbil (cardiac myosin activator)

AMG 594 (cardiac troponin activator)

CK-3773274 (CK-274, cardiac myosin inhibitor)

Skeletal Muscle Program

reldesemtiv (next-generation fast skeletal muscle troponin activator (FSTA))

Pre-Clinical Development and Ongoing Research

Corporate

Financials

Revenues for the first quarter of 2019 increased to $8.5 million from $5.3 million for the first quarter of 2018, primarily due to increased research and development revenues from our collaborations with Astellas and Amgen. License revenues in the first quarter of 2018 were related to the Phase 2 study of reldesemtiv in spinal muscle atrophy completed in 2018.

Research and development expenses for the first quarter of 2019 increased to $23.5 million from $22.1 million for the first quarter of 2018, primarily due to increased spending related to the opening of METEORIC-HF and development of CK-274, offset in part by reduced spending for reldesemtiv as well as for tirasemtiv, following suspension of development of tirasemtiv in late 2017. General and administrative expenses increased slightly to $9.4 million for the first quarter of 2019 from $9.3 million for the first quarter of 2018.

Conference Call and Webcast Information

Members of Cytokinetics’ senior management team will review the company’s first quarter 2019 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 the 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) (United States and Canada) or (706) 679-3078 (international) and typing in the passcode 4486595.

An archived replay of the webcast will be available via Cytokinetics’ website until May 16, 2019. The replay will also be available via telephone by dialing (855) 859-2056 (United States and Canada) or (404) 537-3406 (international) and typing in the passcode 4486595 from May 9, 2019 at 7:30 PM Eastern Time until May 16, 2019.

About Cytokinetics

Cytokinetics is a late-stage biopharmaceutical company focused on discovering, developing and commercializing first-in-class muscle activators and best-in-class muscle inhibitors as potential treatments for debilitating diseases in which muscle performance is compromised and/or declining. As a leader in muscle biology and the mechanics of muscle performance, the company is developing small molecule drug candidates specifically engineered to impact muscle function and contractility. Cytokinetics is collaborating with Amgen Inc. (Amgen) to develop omecamtiv mecarbil, a novel cardiac muscle activator. Omecamtiv mecarbil is the subject of an international Phase 3 clinical trials program in patients with heart failure including GALACTIC-HF and METEORIC-HF. Amgen holds an exclusive worldwide license to develop and commercialize omecamtiv mecarbil with a sublicense held by Servier for commercialization in Europe and certain other countries. Cytokinetics is collaborating with Astellas Pharma Inc. (Astellas) to develop reldesemtiv, a fast skeletal muscle troponin activator (FSTA). Astellas holds an exclusive worldwide license to develop and commercialize reldesemtiv. Licenses held by Amgen and Astellas are subject to specified co-development and co-commercialization rights of Cytokinetics. Cytokinetics is also developing CK-274, a novel cardiac myosin inhibitor that company scientists discovered independent of its collaborations, for the potential treatment of hypertrophic cardiomyopathies. Cytokinetics continues its over 20-year history of pioneering innovation in muscle biology and related pharmacology focused to diseases of muscle dysfunction and conditions of muscle weakness.

For additional information about Cytokinetics, visit www.cytokinetics.com and follow us on Twitter, LinkedIn, Facebook and YouTube.

Forward-Looking Statements

This press release contains forward-looking statements for purposes of the Private Securities Litigation Reform Act of 1995 (the “Act”). Cytokinetics claims the protection of the Act’s Safe Harbor for forward-looking statements. Examples of such statements include, but are not limited to, statements relating to Cytokinetics’ and its partners’ research and development activities, including the initiation, conduct, design, enrollment, progress, continuation, completion, timing and results of clinical trials; the significance and utility of pre-clinical study and clinical trial results; planned interactions with regulatory authorities and the outcomes of such interactions; the expected timing of events and milestones, including the receipt of milestone payments; and the properties and potential benefits of Cytokinetics’ drug candidates. Such statements are based on management's current expectations, but actual results may differ materially due to various risks and uncertainties, including, but not limited to Cytokinetics need for additional funding and such additional funding may not be available on acceptable terms, if at all; potential difficulties or delays in the development, testing, regulatory approvals for trial commencement, progression or product sale or manufacturing, or production of Cytokinetics’ drug candidates that could slow or prevent clinical development or product approval; patient enrollment for or conduct of clinical trials may be difficult or delayed; the FDA or foreign regulatory agencies may delay or limit Cytokinetics’ or its partners’ ability to conduct clinical trials; Amgen’s and Astellas’ decisions with respect to the design, initiation, conduct, timing and continuation of development activities for omecamtiv mecarbil and reldesemtiv, respectively; Cytokinetics may incur unanticipated research and development and other costs; standards of care may change, rendering Cytokinetics’ drug candidates obsolete; and competitive products or alternative therapies may be developed by others for the treatment of indications Cytokinetics’ drug candidates and potential drug candidates may target. For further information regarding these and other risks related to Cytokinetics’ business, investors should consult Cytokinetics’ filings with the Securities and Exchange Commission. Forward-looking statements are not guarantees of future performance, and Cytokinetics' actual results of operations, financial condition and liquidity, and the development of the industry in which it operates, may differ materially from the forward-looking statements contained in this press release. Any forward-looking statements that Cytokinetics makes in this press release speak only as of the date of this press release. Cytokinetics assumes no obligation to update its forward-looking statements whether as a result of new information, future events or otherwise, after the date of this press release.

Contact:
Diane Weiser
Vice President, Corporate Communications, Investor Relations
(415) 290-7757


Cytokinetics, Incorporated
Condensed Consolidated Statements of Operations
(in thousands, except per share data)
(unaudited)

  Three Months Ended 
  March 31, 2019  March 31, 2018 
Revenues:        
Research and development revenues $8,464  $3,585 
License revenues     1,683 
Total revenues  8,464   5,268 
Operating expenses:        
Research and development  23,545   22,135 
General and administrative  9,437   9,264 
Total operating expenses  32,982   31,399 
Operating loss  (24,518)  (26,131)
Interest expense  (1,170)  (863)
Non-cash interest expense on liability related to sale of future royalties  (4,819)  (4,129)
Interest and other income, net  1,141   842 
Net loss $(29,366) $(30,281)
Net loss per share — basic and diluted $(0.54) $(0.56)
Weighted-average shares in net loss per share — basic and diluted  54,821   54,062 



Cytokinetics, Incorporated
Condensed Consolidated Balance Sheets
(in thousands)

  March 31, 2019  December 31, 2018(1) 
   (unaudited)     
ASSETS        
Current assets:        
Cash and short term investments $176,622  $198,731 
Other current assets  9,778   8,943 
Total current assets  186,400   207,674 
Property and equipment, net  3,175   3,204 
Other assets  9,036   300 
Total assets $198,611  $211,178 
LIABILITIES AND STOCKHOLDERS EQUITY        
Current liabilities:        
Accounts payable and accrued liabilities $15,491  $19,521 
Current portion of long-term debt  6,212   2,607 
Short-term lease liability  4,499    
Other current liabilities  75   66 
Total current liabilities  26,277   22,194 
Long-term debt, net  36,382   39,806 
Liability related to the sale of future royalties, net  127,308   122,473 
Long-term lease liability  5,272    
Other long-term liabilities     771 
Total liabilities  195,239   185,244 
Stockholders’ equity:        
Common stock  55   55 
Additional paid-in capital  775,401   768,703 
Accumulated other comprehensive income  606   500 
Accumulated deficit  (772,690)  (743,324)
Total stockholders’ equity  3,372   25,934 
Total liabilities and stockholders’ equity $198,611  $211,178 

(1) Derived from the audited financial statements, included in the Company’s Annual Report on Form 10-K for the year ended December 31, 2018.