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Share Name | Share Symbol | Market | Type |
---|---|---|---|
Genocea Biosciences Inc | NASDAQ:GNCA | NASDAQ | Common Stock |
Price Change | % Change | Share Price | Bid Price | Offer Price | High Price | Low Price | Open Price | Shares Traded | Last Trade | |
---|---|---|---|---|---|---|---|---|---|---|
0.00 | 0.00% | 0.051 | 0.01 | 0.05 | 0 | 01:00:00 |
- Positive Phase 2b clinical data confirm attractive profile for GEN-003; expected to start Phase 3 program in 4Q 2017 -
“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 CallGenocea 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 StatementsStatements 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 assets | 6,534 | 5,710 | |||||
Total assets | $ | 69,896 | $ | 112,142 | |||
Debt, current and long-term | $ | 16,958 | $ | 16,477 | |||
Accounts payable | 3,043 | 1,757 | |||||
Accrued expenses and other liabilities | 4,354 | 4,012 | |||||
Deferred revenue | — | 235 | |||||
Total liabilities | 24,355 | 22,481 | |||||
Stockholders' equity | 45,541 | 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 development | 11,824 | 6,513 | 34,645 | 28,049 | |||||||||||
General and administrative | 3,858 | 3,781 | 15,427 | 13,987 | |||||||||||
Refund of research and development expense | — | — | (1,592 | ) | — | ||||||||||
Total operating expenses | 15,682 | 10,294 | 48,480 | 42,036 | |||||||||||
Loss from operations | (15,682 | ) | (10,073 | ) | (48,245 | ) | (41,366 | ) | |||||||
Other income and expense: | |||||||||||||||
Interest income | 87 | 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 share | 28,394 | 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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