Genocea Biosciences
Feb 16, 2017

Genocea Reports Fourth Quarter and Year-End 2016 Financial Results

- Positive Phase 2b clinical data confirm attractive profile for GEN-003; expected to start Phase 3 program in 4Q 2017 -

- Neoantigen cancer vaccine program on track to file first IND by end of 2017-

- Conference call at 9am ET today -

CAMBRIDGE, Mass., Feb. 16, 2017 (GLOBE NEWSWIRE) -- Genocea Biosciences, Inc. (NASDAQ:GNCA), a biopharmaceutical company developing T cell-directed vaccines and immunotherapies, today reported corporate highlights and financial results for the fourth quarter and year ended December 31, 2016. Genocea is developing GEN-003, a therapeutic vaccine candidate for the treatment of genital herpes expected to enter Phase 3 development in 2017, and is applying its unique and proprietary T cell antigen identification platform, ATLAS™, to immuno-oncology and cancer vaccine development.

"We are proud to report on our 2016 achievements, as we made important advances in both our GEN-003 and immuno-oncology programs," said Chip Clark, president and chief executive officer of Genocea. "With the announcements of positive virologic and clinical data for GEN-003 from our ongoing Phase 2b trial, we believe we have confirmed a highly attractive clinical profile for GEN-003, which has the potential to be the first new treatment for patients with genital herpes in more than 20 years. We are encouraged by market research indicating that the GEN-003 clinical profile is attractive to both physicians and payers, and, most importantly, to patients, many of whom are dissatisfied with their current treatment options."

Mr. Clark continued: "In addition to the progress on GEN-003, we announced last fall that we are now focusing our early stage development resources on our immuno-oncology programs. We believe there is a significant opportunity to use our ATLAS platform in immuno-oncology to comprehensively profile T cell responses to cancer. We believe that we can create value by developing novel therapeutic neoantigen cancer vaccines and by developing non-invasive assays to define patient selection for clinical trials and clinical practice. As we presented at our first-ever R&D Day in December, we are making significant progress in both areas and remain on track to file an IND for our first cancer vaccine (GEN-009) by the end of this year."

Program Highlights

GEN-003 Program Milestones

Immuno-Oncology Program Milestones

Anticipated Upcoming Milestones and Events

Milestones

Events

Financial Guidance

Genocea expects that its existing cash, cash equivalents and investments are sufficient to support its operating expenses and capital expenditure requirements into the first quarter of 2018, without assuming any receipt of proceeds from potential business development partnerships, equity financings or debt drawdowns. This guidance assumes commencing Phase 3 trials for GEN-003 for genital herpes in the fourth quarter of 2017 and filing an IND for GEN-009 for cancer by the end of the year, however it is Genocea's strategy to secure additional sources of financing in advance of starting GEN-003 Phase 3 clinical trials.

Fourth Quarter and Year-End 2016 Financial Results

Full Year 2016 Financial Results

Conference Call
Genocea will host a conference call and webcast today at 9:00 a.m. ET. The conference call may be accessed by dialing (844) 826-0619 for domestic participants and (315) 625-6883 for international callers and referencing the conference ID number 58691835. A live webcast of the conference call will be available online from the investor relations section of the Company's website at http://ir.genocea.com. A webcast replay of the conference call will be available on the Genocea website beginning approximately two hours after the event, and will be archived for 30 days.

About Genocea Biosciences, Inc.
Genocea is harnessing the power of T cell immunity to develop life-changing vaccines and immunotherapies. T cells are increasingly recognized as a critical element of protective immune responses to a wide range of diseases, but traditional discovery methods have proven unable to identify the targets of such protective immunity. Using ATLAS™, its proprietary technology platform, Genocea identifies these targets to potentially enable the rapid development of medicines to address critical patient needs. Genocea's pipeline includes GEN-003, a novel T cell-enabled immunotherapy for genital herpes currently in Phase 2 clinical development, and earlier-stage investments in immuno-oncology. For more information, please visit the company's website at www.genocea.com.

Forward-Looking Statements
Statements herein relating to future business performance, conditions or strategies and other financial and business matters, including expectations regarding clinical developments, are forward-looking statements within the meaning of the Private Securities Litigation Reform Act. Genocea cautions that these forward-looking statements are subject to numerous assumptions, risks and uncertainties, which change over time. Factors that may cause actual results to differ materially from the results discussed in the forward-looking statements or historical experience include risks and uncertainties, including Genocea's ability to progress any product candidates in preclinical or clinical trials; the ability of ATLAS to identify promising oncology vaccine and immunotherapy product candidates; the scope, rate and progress of its preclinical studies and clinical trials and other research and development activities; anticipated clinical trial results; current results may not be predictive of future results; even if the data from preclinical studies or clinical trials is positive, regulatory authorities may require additional studies for approval and the product may not prove to be safe and efficacious; Genocea's ability to enter into future collaborations with industry partners and the government and the terms, timing and success of any such collaboration; risks associated with the manufacture and supply of clinical and commercial product; the cost of filing, prosecuting, defending and enforcing any patent claims and other intellectual property rights; Genocea's ability to obtain rights to technology; competition for clinical resources and patient enrollment from drug candidates in development by other companies with greater resources and visibility; the rate of cash utilized by Genocea in its business and the period for which existing cash will be able to fund such operation; Genocea's ability to obtain adequate financing in the future through product licensing, co-promotional arrangements, public or private equity or debt financing or otherwise; general business conditions; competition; business abilities and judgment of personnel; the availability of qualified personnel and other factors set forth under "Risk Factors" in Genocea's Annual Report on Form 10-K for the fiscal year ended December 31, 2015 and other filings with the Securities and Exchange Commission (the "SEC"). Further information on the factors and risks that could affect Genocea's business, financial conditions and results of operations is contained in Genocea's filings with the SEC, which are available at www.sec.gov. These forward-looking statements speak only as of the date of this press release and Genocea assumes no duty to update forward-looking statements.

 
GENOCEA BIOSCIENCES, INC.
CONDENSED CONSOLIDATED BALANCE SHEETS (UNAUDITED)
(In thousands)
 
 December 31, December 31,
 2016 2015
    
Cash, cash equivalents and investments$63,362  $106,432 
Other assets6,534  5,710 
Total assets$69,896  $112,142 
    
Debt, current and long-term$16,958  $ 16,477 
Accounts payable3,043  1,757 
Accrued expenses and other liabilities4,354  4,012 
Deferred revenue  235 
Total liabilities24,355  22,481 
Stockholders' equity45,541  89,661 
Total liabilities and stockholders' equity$69,896  $112,142 


 
GENOCEA BIOSCIENCES, INC.
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS (UNAUDITED)
(In thousands, except per share amounts)
 
 Three months ended
December 31,
 Twelve months ended
December 31,
 2016 2015 2016 2015
Grant revenue$  $221  $235  $670 
        
Operating expenses:       
  Research and development11,824  6,513  34,645  28,049 
  General and administrative3,858   3,781  15,427  13,987 
  Refund of research and development expense    (1,592)  
Total operating expenses15,682  10,294  48,480  42,036 
Loss from operations(15,682) (10,073) (48,245) (41,366)
Other income and expense:       
  Interest income87  93  410  163 
  Interest expense(439) (334) (1,738) (1,280)
Total other income and expense(352 ) (241) (1,328) (1,117)
Net loss$(16,034) $(10,314) $(49,573) $(42,483)
        
Net loss per share - basic and diluted$(0.56) $(0.37) $ (1.75) $(1.74)
Weighted-average number of common shares used in computing net loss per share28,394  28,118  28,299  24,460 

 

For media:

Jennifer LaVin

O: 617-715-6687

jennifer.lavin@genocea.com



For investors:

Jonathan Poole

O: 617-876-8191

jonathan.poole@genocea.com  

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Source: Genocea Biosciences

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