Genocea Reports Third Quarter 2016 Financial Results
- Positive Phase 2b results recently reported and dose selected for
GEN-003 Phase 3 program expected to initiate in 2H 2017 -
- Conference Call at
"We achieved an important GEN-003 milestone in the third quarter with the
selection of our Phase 3 dose, demonstrating a significant reduction in viral shedding for the third consecutive clinical trial, this time with an improved, Phase 3-ready formulation," said
Recent Business Highlights
GEN-003 - Immunotherapy for treatment of genital herpes expected to enter Phase 3 development in 2H 2017.
September 2016 - data confirm optimal dose for Phase 3 trials; dose response consistent with T cell therapies and with previous GEN-003 clinical trialsOctober 2016 - IDWeek presentation: GEN-003 induced durable polyfunctional T cells, IgG and neutralizing antibody titers
In
The 60 µg per protein / 75 µg of adjuvant dose group in the Phase 2b trial reduced the viral shedding rate by 27 percent, a smaller reduction than that observed in the prior trial, and also showed a less acceptable reactogenicity profile than the prior trial. Research has shown that overstimulation of the T cell immune system, as is suggested by this increase in reactogenicity, leads to a loss in efficacy for T cell therapies. We believe the likely driver of this effect is a more potent adjuvant formulation following customary manufacturing process changes to prepare for Phase 3 trials and commercialization.
In
Anticipated Milestones and Events
GEN-003
- Phase 2b 6-month placebo-controlled clinical efficacy data expected in
January 2017 - End-of-Phase 2 meeting with the
U.S. Food and Drug Administration (FDA) expected in 1Q 2017 - Antiviral combination study now planned as part of GEN-003 Phase 3 program
Immuno-oncology collaborations and cancer vaccine strategy
- Data showing ATLAS's
differentiated neoantigen selection capabilities from the ongoing partnership with
Memorial Sloan Kettering Cancer Center to be presented at theSociety for Immunotherapy of Cancer's (SITC) 31st Annual Meeting & Associated Programs inNational Harbor ,Maryland . The poster, #374, entitled Genome-scale neoantigen screening using ATLAS™ prioritizes candidates for immunotherapy in a non-small cell lung cancer patient will be presented onSaturday November 12 ,between 11:45 am and 1:00 pm and6:45 pm and8 pm ET - Immuno-oncology strategy and neoantigen cancer vaccine development plan update expected at R&D Day in December
Upcoming Events & Presentations
- Neoantigen Summit 2016,
Boston ,November 15 - Stifel 2016 Healthcare Conference,
New York City ,November 16 - Piper Jaffray 28th Annual
Health Care Conference ,New York City ,November 30 - Virtual R&D Day, week of
December 12
Updated Financial Guidance:
Genocea now expects that its existing cash, cash equivalents and marketable securities 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 is made on the basis of Genocea's current operating plans, which include focusing its research activities on immuno-oncology, conducting the antiviral combination study as part of the GEN-003 Phase 3 program and initiating Phase 3 trials for GEN-003 in the second half of 2017.
Third Quarter 2016 Financial Results
Cash Position: Cash, cash equivalents and investments as of
Research and
Development (R&D) Expenses: R&D expenses for the quarter ended
General and Administrative (G&A) Expenses: G&A expenses for the quarter ended
Net Loss: Net loss was $12.8 million for the third quarter ended
Conference Call
Genocea will host a conference call and webcast today at
About
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 ATLASTM, 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 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
CONDENSED CONSOLIDATED BALANCE SHEETS (UNAUDITED) | |||||||
(In thousands) | |||||||
2016 | 2015 | ||||||
Cash, cash equivalents and investments | $ | 75,461 | $ | 106,432 | |||
Other assets | 7,408 | 5,710 | |||||
Total assets | $ | 82,869 | $ | 112,142 | |||
Debt, current and long-term | $ | 16,833 | $ | 16,477 | |||
Accounts payable | 1,888 | 1,757 | |||||
Accrued expenses and other liabilities | 3,799 | 4,012 | |||||
Deferred revenue | — | 235 | |||||
Total liabilities | 22,520 | 22,481 | |||||
Stockholders' equity | 60,349 | 89,661 | |||||
Total liabilities and stockholders' equity | $ | 82,869 | $ | 112,142 |
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS (UNAUDITED) | |||||||||||||||
(In thousands, except per share amounts) | |||||||||||||||
Three months ended | Nine months ended | ||||||||||||||
2016 | 2015 | 2016 | 2015 | ||||||||||||
Grant revenue | $ | — | $ | 213 | $ | 235 | $ | 449 | |||||||
Operating expenses: | |||||||||||||||
Research and development | 8,811 | 6,058 | 22,821 | 21,536 | |||||||||||
General and administrative | 3,619 | 3,645 | 11,569 | 10,206 | |||||||||||
Refund of research and development expense | — | — | (1,592 | ) | — | ||||||||||
Total operating expenses | 12,430 | 9,703 | 32,798 | 31,742 | |||||||||||
Loss from operations | (12,430 | ) | (9,490 | ) | (32,563 | ) | (31,293 | ) | |||||||
Other income and expense: | |||||||||||||||
Interest income | 103 | 39 | 323 | 70 | |||||||||||
Interest expense | (438 | ) | (320 | ) | (1,299 | ) | (946 | ) | |||||||
Total other income and expense | (335 | ) | (281 | ) | (976 | ) | (876 | ) | |||||||
Net loss | $ | (12,765 | ) | $ | (9,771 | ) | $ | (33,539 | ) | $ | (32,169 | ) | |||
Net loss per share - basic and diluted | $ | (0.45 | ) | $ | (0.37 | ) | $ | (1.18 | ) | $ | (1.38 | ) | |||
Weighted-average number of common shares used in computing net loss per share | 28,370 | 26,610 | 28,267 | 23,228 |
For media:Source:Liz Bryan Spectrum Science Communications O: 202-955-6222 lbryan@spectrumscience.com For investors:Jonathan Poole Genocea Biosciences O: 617-876-8191 jonathan.poole@genocea.com
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