Genocea Reports Third Quarter 2014 Financial Results
Novel product candidates for genital herpes and pneumococcus both advanced into Phase 2 clinical trials
"During the third quarter we continued to advance our novel vaccine and immunotherapy pipeline. I'm particularly pleased with enrollment in the Phase 2 dose optimization trial for our genital herpes program, GEN-003, reflecting both strong patient and physician motivation and our execution capabilities. We also initiated a Phase 2 trial for GEN-004 for pneumococcus and presented important data from both programs at major medical meetings," said Chip Clark, president and chief executive officer of Genocea. "These achievements reinforce our progress toward bringing disruptive medicines to the large genital herpes and pneumococcal markets and reaffirms that our ATLAS™ discovery platform rapidly advances novel products into development and towards patients and physicians who need them."
Recent Business Highlights
GEN-003 immunotherapy for genital herpes
Presented final GEN-003 Phase 1/2a clinical data at IDWeek 2014 in
Philadelphiain October: Final results expanded on the top-line results announced in July and included the 12 month efficacy, safety, and immunogenicity findings of the Phase 1/2a study of GEN-003, Genocea's first-in-class T cell-directed immunotherapy for the treatment of genital herpes. At 12 months after the final dose, the mean reduction in the genital lesion rate was 42 percent below baseline for the 30 microgram dose group. GEN-003 also elicited T cell, IgG, and neutralizing antibody responses that remained significantly above baseline for 12 months. GEN-003 is the only immunotherapy for genital herpes to demonstrate a reduction in the signs of clinical disease as measured by genital lesion rates. In July, Genocea initiated a Phase 2 study to determine the optimal dose for future trials.
- Announced the publication of a paper on Genocea's genital herpes antigen discovery in Virology in September: The peer-reviewed journal Virology published "Identification of novel virus-specific antigens by CD4+ and CD8+ T cells from asymptomatic HSV-2 seropositive and seronegative donors" which described how Genocea used its ATLAS™ platform to identify multiple antigens that are associated with naturally-induced protective CD4+ and CD8+ T cell responses to herpes simplex virus-2, enabling both the design of GEN-003 and presenting possible additional targets for the development of next generation immunotherapies against genital herpes.
GEN-004 universal vaccine for the prevention of pneumococcal infections
- Initiated GEN-004 Phase 2a human challenge study in September: This trial will evaluate the effect of GEN-004 on the frequency, magnitude and duration of colonization by pneumococcus in the nasopharynx of healthy adults. As colonization is known to be the necessary precursor to infection by pneumococcus, this study could affirm the potential for GEN-004 to control infections caused by pneumococcus.
Presented GEN-004 Phase 1 clinical data in a poster at the 54th
Interscience Conference on Antimicrobial Agents and Chemotherapy(ICAAC) in Washington, DC. in September: Results reiterated the top-line results announced in June which showed that GEN-004 met its safety, tolerability and immunogenicity goals, including increases in the blood of T helper 17 (TH17) cells, a rare cell type that provides immunity at epithelial and mucosal surfaces. GEN-004 was also found to be safe and well tolerated at all doses, with no serious adverse events related to the vaccine.
$1.2Mgrant for malaria vaccine discovery from the Bill & Melinda Gates Foundationin September: The grant extends Genocea's existing malaria collaboration with the foundation through 2015 and supports comprehensive screening of the malaria proteome to identify targets of protective T cell responses.
Kenneth Bateto Board of Directors in September: Kenneth Batewill serve as chairman of the company's Compensation committee and a member of the Audit committee. He is currently chairman of the board of Cubist Pharmaceuticals and is a director of BioMarin Pharmaceuticals, AVEO Pharmaceuticals and Catabasis Pharmaceuticals. Mr. Batepreviously served as president and chief executive officer of Archemix Corp.and NitroMed Inc., chief financial officer of Millennium Pharmaceuticals Inc.and Biogen Inc., and co-founded JSB Partners LLC.
Third Quarter 2014 Financial Results & Financial Guidance
- Cash Position: Cash, cash equivalents and marketable securities as of September 30, 2014 were $52.2 million, compared to $59.2 million as of June 30, 2014. Genocea expects that these funds will be sufficient to fund its operating expenses and capital expenditure requirements until at least the end of 2015.
Research and Development (R&D) Expenses: R&D expenses this
$6.1 million, compared to $3.3 millionin the third quarter of 2013, reflecting higher personnel costs and the continued advancement of both of our clinical programs into Phase 2 trials.
- General and Administrative (G&A) Expenses: G&A expenses were $2.8 million in the third quarter of 2014, compared to $1.4 million in the comparable period in 2013 reflecting additional personnel costs and increased costs to support our public company operations.
- Net Loss: Net loss was $9.2 million for the third quarter of 2014, compared to a net loss of $4.8 million for the comparable period in 2013.
Anticipated Upcoming Milestones:
- GEN-003 Phase 2 dose optimization trial: Top-line results are expected in mid-2015.
- GEN-004 Phase 2a human challenge study: Top-line results are expected in mid-2015.
Genocea will be hosting a conference call and webcast today, November 6, 2014, at 9:00 a.m. EST. The conference call may be accessed by dialing (844) 826-0619 for domestic participants and (315) 625-6883 for international callers (reference conference ID 10513540). 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-enabled product candidates includes GEN-003 for HSV-2 therapy, GEN-004 to prevent infections caused by pneumococcus, and earlier-stage programs in chlamydia, HSV-2 prophylaxis, malaria and cancer immunotherapy. 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;
clinical trial results; current results may not be predictive of future
results; even if the data from preclinical studies or clinical trials is
positive, 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; 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;
it'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||$||52,193||$||12,208|
|Redeemable convertible preferred stock||-||81,562|
|Stockholders' equity (deficit)||40,964||(80,131||)|
Total liabilities, redeemable convertible preferred
CONDENSED STATEMENTS OF OPERATIONS (UNAUDITED)
(In thousands, except per share amounts)
Three months ended
Nine months ended
|Research and development||6,115||3,275||15,073||11,354|
|General and administrative||2,843||1,423||7,167||3,113|
|Total operating expenses||8,958||4,698||22,240||14,467|
|Loss from operations||(8,958||)||(4,475||)||(22,240||)||(13,756||)|
|Other expense, net||(213||)||(364||)||(1,406||)||(704||)|
Accretion of redeemable convertible
|Net loss attributable to common stockholders||$||(9,171||)||$||(5,243||)||$||(23,826||)||$||(15,660||)|
Net loss per share attributable to common
Weighted-average number of common
News Provided by Acquire Media