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): October 31, 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 October 31, 2019, the Registrant issued a press release, a copy of which is attached hereto as Exhibit 99.1 and is incorporated herein by reference.

Item 9.01. Financial Statements and Exhibits.

Exhibit 99.1. Press release dated October 31, 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: October 31, 2019By: /s/ Robert Wong        
  Robert Wong
  VP, Chief Accounting Officer
  

EdgarFiling

EXHIBIT 99.1

Cytokinetics Reports Third Quarter 2019 Financial Results

Enrollment Completed in GALACTIC-HF with More than 8,200 Heart Failure Patients; 
Second Interim Analysis Expected in Q1 2020

Data from Phase 1 Study of CK-274 Support Progression;
Phase 2 Clinical Trial in Patients with Obstructive Hypertrophic Cardiomyopathy to Begin in Q4 2019

Faster Progressing Patients Receiving Reldesemtiv in FORTITUDE-ALS Experienced Slower Decline
in ALSFRS-R and Greater Difference from Placebo than Slower Progressing Patients

SOUTH SAN FRANCISCO, Calif., Oct. 31, 2019 (GLOBE NEWSWIRE) -- Cytokinetics, Incorporated (Nasdaq:CYTK) reported financial results for the third quarter of 2019. Net loss for the third quarter was $29.6 million, or $0.50 per share, compared to net loss for the third quarter of 2018 of $22.0 million, or $0.40 per share. Cash, cash equivalents and investments totaled $166.0 million at September 30, 2019.

“In the third quarter of 2019, we achieved major milestones in both our cardiovascular and neuromuscular programs representing progress on key priorities across our pipeline of muscle-directed therapies,” said Robert I. Blum, Cytokinetics’ President and Chief Executive Officer. “Completion of enrollment of GALACTIC-HF represents a significant step forward towards the completion of this important trial which holds promise for advancing the treatment of millions of patients suffering from heart failure. Additionally, recently presented Phase 1 data for CK-274 reaffirms its next-generation profile and supports advancing this program into a Phase 2 trial in patients with obstructive hypertrophic cardiomyopathy this year. Furthermore, additional analyses of results from FORTITUDE-ALS, as well as ongoing regulatory interactions, provide support for a potential Phase 3 trial of reldesemtiv in patients with ALS next year. We believe this progress positions us well to leverage our leadership in muscle pharmacology to benefit a wide array of patients suffering from varied diseases of muscle dysfunction.”

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 three and nine months ended September 30, 2019 were $6.1 million and $21.7 million, respectively, compared to $10.6 million and $22.1 million for the corresponding periods in 2018. The decrease in revenues for the three and nine months ended September 30, 2019 was due primarily to the winding down of FORTITUDE-ALS in addition to a lack of license revenue in 2019. License revenues in the third quarter and first nine months of 2018 were related to the Phase 2 trial of reldesemtiv in spinal muscular atrophy completed in 2018. 

Research and development expenses for the three and nine months ended September 30, 2019 were $20.2 million and $67.8 million, respectively compared to $21.4 million and $65.9 million for the same periods in 2018, respectively. The changes were primarily due to reduced spending for reldesemtiv as well as tirasemtiv following suspension of development of tirasemtiv in late 2017 offset by increased spending related to METEORIC-HF and the development of CK-274.

General and administrative expenses for the three and nine months ended September 30, 2019 increased to $9.8 million and $29.0 million, respectively, from $7.2 million and $23.7 million for the same periods in 2018, respectively, due primarily to an increase in outside legal counsel and personnel related costs including stock-based compensation.

Conference Call and Webcast Information

Members of Cytokinetics’ senior management team will review the company’s third 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 9440838.

An archived replay of the webcast will be available via Cytokinetics’ website until November 7, 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 9440838 from October 31, 2019 at 7:30 PM Eastern Time until November 7, 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 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) for diseases of neuromuscular dysfunction, including SMA and ALS. 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; the agreement in principle to revise the terms of the collaboration agreement between Astellas and Cytokinetics; 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 Nine Months Ended
  September 30, 2019 September 30, 2018 September 30, 2019 September 30, 2018
Revenues:        
Research and development revenues $  6,055  $   8,726  $   21,656  $   16,991 
License revenues    —     1,915     —     5,133 
Total revenues    6,055     10,641     21,656     22,124 
Operating expenses:        
Research and development    20,229     21,391     67,791     65,858 
General and administrative    9,753     7,164     29,026     23,724 
Total operating expenses    29,982     28,555     96,817     89,582 
Operating loss    (23,927)    (17,914)    (75,161)    (67,458)
Interest expense    (1,345)    (867)    (3,892)    (2,628)
Non-cash interest expense on liability related to the sale of future royalties    (5,321)    (4,559)    (15,204)    (13,026)
Interest and other income    1,020     1,323     3,205     3,291 
Net (loss) income before income taxes    (29,573)    (22,017)    (91,052)    (79,821)
Income tax benefit    -     -     -     - 
Net loss $  (29,573) $   (22,017) $   (91,052) $  (79,821)
Net loss per share — basic and diluted $  (0.50) $   (0.40) $   (1.60) $  (1.47)
Weighted-average shares in net loss per share — basic and diluted    58,640     54,626     57,050     54,329 


Cytokinetics, Incorporated

Condensed Consolidated Balance Sheets
(in thousands)

  September 30, 2019 December 31, 2018(1)
  (unaudited)   
 ASSETS     
 Current assets:    
 Cash and short term investments $  166,039  $  198,731 
 Other current assets    10,496     8,943 
 Total current assets    176,535     207,674 
 Property and equipment, net    3,615     3,204 
 Other assets    7,243     300 
 Total assets $  187,393  $  211,178 
 LIABILITIES AND STOCKHOLDERS’ EQUITY     
 Current liabilities:    
 Accounts payable and accrued liabilities $  16,551  $  19,521 
 Current portion of long-term debt    -     2,607 
 Short-term lease liability    4,577     — 
 Other current liabilities    389     66 
 Total current liabilities    21,517     22,194 
 Long-term debt, net    44,762     39,806 
 Liability related to the sale of future royalties, net    137,726     122,473 
 Long-term lease liability    3,257     — 
 Other long-term liabilities    —     771 
 Total liabilities    207,262     185,244 
 Stockholders’ equity:    
 Common stock    59     55 
 Additional paid-in capital    813,729     768,703 
 Accumulated other comprehensive income     719     500 
 Accumulated deficit    (834,376)    (743,324)
 Total stockholders’ equity    (19,869)    25,934 
 Total liabilities and stockholders’ equity $  187,393  $  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.