Phase 2 top-line data for GEN-003 for the treatment of genital herpes expected this quarter
"2015 is an important year for Genocea with significant clinical data
readouts upcoming for both our lead programs. Top-line Phase 2 data for
GEN-003, for the treatment of genital herpes, is expected this quarter.
Building on the first-in-class efficacy data we reported in 2014 from
our Phase 1/2a trial, the selection of the best dose in this trial
represents an important validating step towards advancing this program
into Phase 3," said
Business Highlights and Anticipated Milestones
GEN-003 - Immunotherapy for genital herpes in Phase 2 dose
optimization trial. >
Genocea expects to report the viral shedding rate and genital lesion rate changes from baseline for each dose group for the 28-day monitoring period after vaccination late in the second quarter of 2015.
GEN-004 - Vaccine for the prevention of infections by all
serotypes of pneumococcus in ongoing Phase 2a human challenge study.
Potentially disruptive to greater than
Genocea announced in
Top-line results from this trial evaluating the effect of GEN-004 on the frequency, magnitude and duration of colonization by pneumococcus in the nasopharynx of healthy adults are expected in the fourth quarter of 2015.
Existing vaccines for pneumococcus command a greater than
The financing has enabled Genocea to accelerate manufacturing investment
in GEN-003 and, in doing so, bring forward the expected date of the
end-of-Phase 2 meeting with the
Genocea announced in
First Quarter 2015 Financial Results & Financial Guidance
Genocea will host a conference call and webcast today, at 9:00 a.m. EDT. The conference call may be accessed by dialing (844) 826-0619 for domestic participants and (315) 625-6883 for international callers (reference conference ID 29667440). 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.
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 immune response. 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-directed product candidates includes GEN-003 to treat genital herpes, GEN-004 to prevent infections caused by pneumococcus, and earlier-stage programs in chlamydia, genital herpes prophylaxis, malaria and cancer immunotherapies. 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 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 BALANCE SHEETS (UNAUDITED)
|Cash, cash equivalents and marketable securities||$||84,493||$||47,079|
|Total liabilities, and stockholders' equity||$||88,416||$||50,431|
(In thousands, except per share amounts)
CONDENSED STATEMENTS OF OPERATIONS (UNAUDITED)
Three months ended
|Research and development||8,509||4,407|
|General and administrative||3,389||1,966|
|Total operating expenses||11,898||6,373|
|Loss from operations||(11,777||)||(6,373||)|
|Other expense, net||(307||)||(956||)|
|Accretion of redeemable convertible preferred stock to redemption value||-||(180||)|
|Net loss attributable to common stockholders||$||(12,084||)||$||(7,509||)|
|Net loss per share attributable to common stockholders - basic and diluted||$||(0.64||)||$||(0.76||)|
|Weighted-average number of common shares used in net loss per share attributable to common stockholders - basic and diluted||18,834||9,859|
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