"Full results from the Phase 2 dose optimization trial evaluating GEN-003, our immunotherapy for genital herpes, were showcased at ASM Microbe 2016 in June. The data show that a single course of treatment has significant and durable effects on both HSV-2 viral activity and genital herpes clinical disease for at least 12 months post dosing. Based on this clinical profile, we believe GEN-003 may offer benefits similar to a full year of daily administration of oral antivirals, giving us confidence in the potential for GEN-003 to become a cornerstone therapy for patients suffering with genital herpes," said
Recent Business Highlights and Anticipated Milestones
GEN-003 - Immunotherapy for treatment of genital herpes in Phase 2 development. Greater than
Multiple anticipated upcoming clinical and regulatory milestones for GEN-003
In September, Genocea expects to report viral shedding data from an ongoing Phase 2b trial. Approximately 135 subjects have been randomized to one of three dose groups - placebo, 60 µg per protein / 50 µg of adjuvant and 60 µg per protein / 75 µg of adjuvant - and are being monitored for 12 months.
Around the end of 2016, Genocea expects to report 6-month clinical efficacy data from this Phase 2b trial. The placebo-controlled data will represent the first opportunity to measure GEN-003 against potential Phase 3 clinical endpoints at 6-months after dosing.
Following these two data readouts, Genocea expects to conduct an end-of-Phase 2 meeting with the
Genocea also expects to commence a Phase 2b antiviral combination study in the fourth quarter of 2016. Six-month clinical efficacy data from this trial is expected in the second half of 2017. If GEN-003 is additive to the effect of chronic suppressive oral anti-viral therapy, the Company believes this would further strengthen GEN-003's value proposition to patients and physicians.
Immuno-oncology collaborations and cancer vaccine strategy
Genocea continues to advance its collaborations with
Expanded company leadership
Second Quarter 2016 Financial Results and Guidance
Genocea will host a conference call and webcast today at
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.
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 of novel clinical stage T cell-enabled product candidates includes GEN-003 for genital herpes, GEN-004 for the prevention of infection by all serotypes of pneumococcus (development suspended), and earlier-stage programs in chlamydia, genital herpes, malaria, Epstein-Barr virus infections and related cancers, and cancer immunotherapy. For more information, please visit the company's website at www.genocea.com.
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)
|Cash, cash equivalents and investments||$||85,974||$||106,432|
|Accrued expenses and other liabilities||3,173||4,012|
|Total liabilities and stockholders' equity||$||92,864||$||112,142|
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS (UNAUDITED)
(In thousands, except per share amounts)
ended||Six months ended|
|Research and development||6,678||6,969||14,010||15,478|
|General and administrative||4,026||3,172||7,950||6,561|
|Refund of research and development expense||—||—||(1,592||)||—|
|Total operating expenses||10,704||10,141||20,368||22,039|
|Loss from operations||(10,704||)||(10,026||)||(20,133||)||(21,803||)|
|Other income and expense:|
|Total other income and expense||(319||)||(288||)||(641||)||(595||)|
|Net loss per share - basic and diluted||$||(0.39||)||$||(0.43||)||$||(0.74||)||$||(1.04||)|
|Weighted-average number of common shares used in computing net loss per share||28,276||24,154||28,214||21,510|
Liz Bryan Spectrum Science CommunicationsO: 202-955-6222 email@example.com For investors: Jonathan Poole Genocea BiosciencesO: 617-876-8191 firstname.lastname@example.org
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