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): April 26, 2018  

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. [   ]

 
 

Item 2.02. Results of Operations and Financial Condition.

On April 26, 2018, Cytokinetics, Incorporated issued a press release announcing its results for the quarter ended March 31, 2018. 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.

(d) Exhibits.

Exhibit 99.1. Press release dated March 31, 2018


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: April 26, 2018By: /s/ Peter S. Roddy        
  Peter S. Roddy
  Senior Vice President, Chief Accounting Officer
  

EdgarFiling

EXHIBIT 99.1

Cytokinetics, Inc. Reports First Quarter 2018 Financial Results

Completed Enrollment in Phase 2 Study of Reldesemtiv in Patients with SMA;
Data Expected in Q2 2018

Preparing to Initiate Second Phase 3 Clinical Trial of Omecamtiv Mecarbil

SOUTH SAN FRANCISCO, Calif., April 26, 2018 (GLOBE NEWSWIRE) -- Cytokinetics, Incorporated (Nasdaq:CYTK) reported financial results for the first quarter of 2018. Net loss for the first quarter was $30.3 million, or $0.56 per share, compared to a net loss for the first quarter of 2017 of $25.9 million, or $0.62 per share. Cash, cash equivalents and investments totaled $255.5 million at March 31, 2018.

“In the first quarter of 2018 we made progress advancing our muscle biology directed drug candidates in mid- and late-stage clinical trials across diseases and conditions of impaired muscle function,” said Robert I. Blum, Cytokinetics’ President and Chief Executive Officer. “We completed enrollment of our Phase 2 clinical study of reldesemtiv in patients with spinal muscular atrophy and look forward to data from that study in the second quarter which may inform future development of reldesemtiv under our collaboration with Astellas. In addition, we made further preparations to initiate the second Phase 3 clinical trial of omecamtiv mecarbil in patients with heart failure under our collaboration with Amgen. We also continued preclinical development activities with the objective of advancing two drug candidates into Phase 1 trials.”

Recent Highlights and Upcoming Milestones

Cardiac Muscle Program

omecamtiv mecarbil (cardiac myosin activator)

Skeletal Muscle Program

tirasemtiv (fast skeletal muscle troponin activator (FSTA))

reldesemtiv (CK-2127107, next-generation FSTA)

Pre-Clinical Research and Development             

Corporate

Annual Stockholders' Meeting

Cytokinetics’ Annual Stockholders’ Meeting will be held on Wednesday, May 16, 2018 at 10:30 AM Pacific Time at the Embassy Suites Hotel in South San Francisco, CA and simultaneously webcast.

Financials

Revenues for the first quarter of 2018 consisted of revenues from our collaboration with Astellas, including research and development revenues of $3.6 million and license revenues of $1.7 million.

Research and development expenses fell to $22.1 million for the first quarter of 2018 from $26.2 million for the fourth quarter of 2017. General and administrative expenses fell to $9.3 million for the first quarter of 2018 from $10.3 million for the fourth quarter of 2017.

Conference Call and Webcast Information

Members of Cytokinetics’ senior management team will review the company’s first 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 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 3488889.

An archived replay of the webcast will be available via Cytokinetics’ website until May 3, 2018. 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 3488889 from April 26, 2018 at 7:30 PM Eastern Time until May 3, 2018.

About Cytokinetics

Cytokinetics is a late-stage biopharmaceutical company focused on discovering, developing and commercializing first-in-class muscle activators 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 increase 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 GALACTIC-HF, an international Phase 3 clinical trial in patients with heart failure. 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 (CK-2127107), a next-generation FSTA. Reldesemtiv has been granted orphan drug designation by the FDA for the potential treatment of SMA. Reldesemtiv is the subject of three ongoing Phase 2 clinical trials enrolling patients with spinal muscular atrophy, chronic obstructive pulmonary disease and ALS. Astellas is also conducting a Phase 1b clinical trial of reldesemtiv in elderly adults with limited mobility. Astellas holds an exclusive worldwide license to develop and commercialize reldesemtiv. Licenses held by Amgen and Astellas are subject to Cytokinetics' specified co-development and co-commercialization rights. Cytokinetics continues its 20-year history of innovation with three new muscle biology directed compounds advancing from research to development in 2018.  For additional information about Cytokinetics, visit www.cytokinetics.com.

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; 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, 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
(650) 624-3000

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

 
  Three Months Ended 
  March 31, 2018  March 31, 2017 
Revenues:        
Research and development, grant and other revenues, net $3,585  $2,707 
License revenues  1,683   1,446 
Total revenues  5,268   4,153 
Operating expenses:        
Research and development  22,135   19,289 
General and administrative  9,264   8,115 
Total operating expenses  31,399   27,404 
Operating loss  (26,131)  (23,251)
Interest expense  (863)  (745)
Non-cash interest expense on liability related to sale of future royalties  (4,129)  (2,307)
Interest and other income, net  842   436 
Net loss $(30,281) $(25,867)
Net loss per share - basic and diluted $(0.56) $(0.62)
Weighted-average shares used to compute net loss per share — basic and diluted  54,062   41,578 
 


Condensed Consolidated Balance Sheets

(in thousands)

 
  March 31, 2018  December 31, 2017(1) 
  (unaudited)     
 ASSETS        
 Current assets:        
 Cash and short term investments $251,454  $268,891 
 Other current assets  20,885   5,404 
  Total current assets  272,339   274,295 
 Long-term investments  4,015   16,518 
 Property and equipment, net  3,156   3,568 
 Other assets  416   429 
  Total assets $279,926  $294,810 
 LIABILITIES AND STOCKHOLDERS’ EQUITY        
 Current liabilities:        
 Accounts payable and accrued liabilities $30,469  $22,645 
 Deferred revenue, current  7,842   9,572 
 Other current liabilities  235   227 
  Total current liabilities  38,546   32,444 
 Long-term debt, net  31,954   31,777 
 Liability related to the sale of future royalties, net  108,792   104,650 
 Deferred revenue, non-current     15,000 
 Other long-term liabilities  1,035   1,097 
  Total liabilities  180,327   184,968 
 Stockholders’ equity:        
 Common stock  54   54 
 Additional paid-in capital  757,405   755,526 
 Accumulated other comprehensive income  489   343 
 Accumulated deficit  (658,349)  (646,081)
  Total stockholders’ equity  99,599   109,842 
  Total liabilities and stockholders’ equity $279,926  $294,810 
 

(1) Derived from the audited financial statements, included in the Company’s Annual Report on Form 10-K for the year ended December 31, 2017.