Genocea Reports First Quarter 2017 Financial Results and Positive Clinical Developments on Lead Candidate GEN-003 in Genital Herpes
- Data from GEN-003 Phase 2 trial indicate initial course of injections sustains clinical and virologic efficacy for at least 24 months -
- End of Phase 2 meeting successfully completed for GEN-003; expect to be Phase 3-ready by end of 2017 -
- Neoantigen cancer vaccine candidate GEN-009 IND filing expected by end of 2017 -
- Conference call today at
In a Phase 2 study, GEN-003 demonstrated sustained reductions compared to baseline in the genital lesion rate (percent of days with genital lesions) and the viral shedding rate (percent of days with detectable virus) in genital herpes patients 24 months after dosing across multiple dose groups (see detailed data below). In addition, Genocea has now successfully completed its End of Phase 2 meeting with the
last earnings announcement,"
GEN-003 Phase 2 Clinical Results
The 24-month clinical results announced today come from an extension of a Phase 2 dose-optimization study that started in 2014 and enrolled 310 subjects from 17 institutions in
Genocea has already advanced the two most promising doses (60 µg per protein combined with either 50 or 75 µg of adjuvant) from this Phase 2 trial into an ongoing Phase 2b efficacy trial, from which positive 6-month, placebo-controlled clinical efficacy data were announced in
|60 µg per protein /|
50 µg of Matrix-M
|60 µg per protein /|
75 µg of Matrix-M
|Viral shedding rate reduction*||41%|
(p < 0.01)
(p < 0.0004)
(p < 0.0001)
(p < 0.006)
(p < 0.0001)
(p < 0.01)
|Genital lesion rate reduction*||69%|
(p < 0.0005)
(p < 0.01)
(p < 0.003)
(p < 0.02)
(p < 0.03)
(p < 0.02)
* Mean rate reduction vs. pre-dosing baseline levels. Statistical analysis performed using a Poisson mixed effect model with empirical variance: Magaret, Amalia, "Models for HSV shedding must account for two levels of overdispersion" ((
** Per prospectively defined clinical trial protocol, descriptive results only, no statistical testing performed.
Anticipated Upcoming Milestones and Events
May 12-16, 2017: AAI's IMMUNOLOGY 2017™ - Genocea will be presenting the first data from its Epstein-Barr Virus (EBV)-related cancer program, highlighting that ATLAS has identified novel and unexpected antigens of T cell responses in the widely studied, cancer-causing virus. June 13, 2017: Annual Meeting of Shareholders at the offices of Ropes & Gray in Boston July 29- August 2, 2017: 42nd Annual International Herpesvirus Workshop(IHW 2017) - Genocea will be presenting data on its GEN-003 Phase 2b clinical trial
- Mid-2017: GEN-003 12-month Phase 2b data anticipated
- 4Q 2017: GEN-003 expected to be ready for Phase 3 development
- 4Q 2017: GEN-009 neoantigen cancer vaccine Investigational New Drug (IND) application filing expected
Genocea expects that its existing cash, cash equivalents and investments are sufficient to support its operating expenses, capital expenditure requirements and debt obligations into the first quarter of 2018, without assuming any receipt of proceeds from potential business development partnerships or equity financings. This guidance assumes commencing Phase 3 trials for GEN-003 for genital herpes around the end 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.
First-Quarter 2017 Financial Results
- Cash Position: Cash, cash equivalents and investments as of
March 31, 2017were $48.7 millioncompared to $63.4 millionas of December 31, 2016.
- Research and Development (R&D) Expenses: R&D expenses for the quarter ended
March 31, 2017increased $2.4 million, to $9.7 million, from the same period in 2016. The increase was driven by higher compensation, consulting and professional services costs in support of the GEN-003 program and increases in manufacturing costs related to supply for Genocea's anticipated Phase 3 clinical program. Spending increases on GEN-009 and immuno-oncology programs were more than offset by lower costs on deprioritized infectious disease programs.
- General and Administrative (G&A) Expenses: G&A expenses for the first quarter of 2017 were $3.6 million, compared to $3.9 million for the same period in 2016 reflecting improved operating leverage.
- Refund of Research and Development Expense: A gain of
$1.6 millionfor the quarter ended March 31, 2016resulted from cash received pursuant to contractual obligations under a collaboration agreement with Isconova AB("Isconova") (since acquired by Novavax, Inc.) to refund R&D expenses paid by Genocea to Isconovabetween 2009 and 2011 relating to the development of the Matrix-M adjuvant technology.
- Net Loss: Net loss was $13.7
million for the quarter ended
March 31, 2017, compared to a net loss of $9.8 million for the same period in 2016.
Genocea will host a conference call and webcast today at
Genocea is harnessing the power of T cell immunity to develop life-changing vaccines and immunotherapies. While traditional immunotherapy discovery methods have largely used predictive methods to propose T cell targets, or antigens, Genocea has successfully developed ATLAS™, its proprietary technology platform, to identify clinically relevant antigens of T cells based on actual human immune responses. Genocea used ATLAS to identify the antigens in its lead clinical candidate, GEN-003, an investigational immunotherapy to treat genital herpes, and is currently using ATLAS in immuno-oncology applications to develop neoantigen cancer vaccines and to identify T cell response signatures of cancer patients treated with checkpoint blockade therapies to potentially improve clinical practice. Genocea expects GEN-003 to be ready to begin Phase 3 development and to file an IND for its neoantigen cancer vaccine candidate GEN-009 by the end of 2017. 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||$||48,675||$||63,362|
|Debt, current and long-term||$||17,083||$||16,958|
|Accrued expenses and other liabilities||2,603||4,354|
|Total liabilities and stockholders' equity||$||55,645||$||69,896|
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS (UNAUDITED)
(In thousands, except per share amounts)
|Three months ended|
|Research and development||9,742||7,332|
|General and administrative||3,634||3,924|
|Refund of research and development expense||—||(1,592||)|
|Total operating expenses||13,376||9,664|
|Loss from operations||(13,376||)||(9,429||)|
|Other income and expense:|
|Total other income and expense||(359||)||(322||)|
|Net loss per share - basic and diluted||$||(0.48||)||$||(0.35||)|
|Weighted-average number of common shares used in computing net loss per share||28,496||28,152|
Jennifer LaVin207-360-0473 email@example.com For investors: Jonathan Poole617-876-8191 firstname.lastname@example.org
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