Genocea Reports First Quarter 2014 Financial Results
"During the first quarter, Genocea continued to make important strides
toward our goal of developing and commercializing life-changing T
cell-enabled medicines," said
Completed Initial Public Offering: In
February 2014, Genocea completed an initial public offering (IPO) of common stock, raising net proceeds of $61.4 million. The Company joined the Russell 3000® and Russell 2000® indices in April 2014.
Presented GEN-003 six month clinical data at
World Vaccine Congressin March: Results from the ongoing Phase 1/2a study of GEN-003 to treat patients infected with herpes simplex virus type 2 (HSV-2) demonstrated a durable and highly statistically significant reduction in clinical symptoms and viral shedding at six months after initial dosing.
Signed supply agreement with FUJIFILM Diosynth Biotechnologies
U.S.A., Inc.: In February 2014, the Company entered into a supply agreement with Fujifilm for the manufacture and supply of protein antigens for its upcoming GEN-003 Phase 2 dose optimization clinical study.
- Completed enrollment in the GEN-004 Phase 1 study
Presented data at 9th Annual International
Symposium on Pneumococci and Pneumococcal Diseases in March: In a
poster presentation, Genocea demonstrated that a single protein fusion
of the three GEN-004 antigens significantly reduced colonization by
pneumococcus in a mouse model. In addition, Genocea Executive Director
and Chairman of the
Scientific Advisory Board, George Siber, M.D., co-led a plenary session, discussing the role of T cell responses in protection from pneumococcal infections.
Announced Dana-Farber Cancer Institute/Harvard Medical Schoolcollaboration: On March 3, 2014, Genocea announced a joint research collaboration with Dana-Farber Cancer Instituteand Harvard Medical Schoolto characterize anti-tumor T cell responses in melanoma patients, extending the use of the Company's proprietary ATLAS™ platform to cancer immunotherapy.
Expanded management team with appointment of
Jonathan Pooleas chief financial officer. Mr. Poole's deep finance and strategic planning expertise in the biopharmaceutical industry further strengthens the Company's leadership team.
First Quarter 2014 Financial Results & Financial Guidance
Cash Position: Cash and cash equivalents as of
March 31, 2014were $65.8 million, compared to $12.2 millionas of December 31, 2013. The increase was primarily driven by net proceeds of $61.4 millionfrom the initial public offering of 5.5 million shares of the Company's common stock, which was completed in February 2014.
R&D Expenses: Research and development expenses were
$4.4 millionin the first quarter of 2014, compared to $4.0 millionin the comparable period in 2013. The increase in R&D expenses was largely due to increased costs for the GEN-003 clinical program and higher R&D personnel costs, offset by lower costs for the GEN-004 clinical program, where manufacturing costs for the ongoing Phase 1 clinical trial were incurred in the first quarter of 2013.
G&A Expenses: General and administrative expenses were
$2.0 millionin the first quarter of 2014, compared to $0.8 millionin the comparable period in 2013. The increase in G&A expenses was largely due to incremental expenses to support the initial public offering and subsequent public company operations and an increase in non-cash stock based compensation expense.
Net Loss: Net loss was
$7.3 millionfor the first quarter of 2014, compared to net loss of $4.7 millionfor the comparable period in 2013.
- Financial Guidance: Genocea expects that its cash and cash equivalents will be sufficient to fund its operating expenses and capital expenditure requirements until at least the end of 2015.
"With the proceeds from the IPO, we plan to create value for our
shareholders by advancing our clinical programs through defined and
meaningful clinical milestones and by continuing our research to unlock
the potential value of our ATLAS platform," said
Anticipated Upcoming Milestones
- GEN-003 Phase 1/2a 12-month results: Genocea expects to announce 12-month data from this study in mid-2014.
- GEN-003 Phase 2 dose optimization trial initiation: Genocea plans to initiate a Phase 2 dose optimization trial in the second quarter of 2014.
- GEN-004 Phase 1 trial results: Genocea expects to announce safety and immunogenicity results from this study in the second quarter of 2014.
- GEN-004 Phase 2 trial initiation: Genocea plans to initiate a Phase 2 human challenge study in the third quarter of 2014.
Genocea will be hosting a conference call and webcast today,
Genocea is harnessing the power of T cell immunity to develop the next generation of vaccines and immunotherapies. T cells are increasingly recognized as a critical element of protective immune responses to a wide range of diseases, but are difficult to target using traditional discovery methods. Genocea is able to identify protective T cell antigens in humans using ATLAS™, its proprietary technology platform, potentially enabling vaccines and immunotherapies 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.
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; our
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; our 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 SHEET (UNAUDITED)
(In thousands, except per share amounts)
|Cash and cash equivalents||$||65,839||$||12,208|
|Redeemable convertible preferred stock||-||81,562|
|Stockholders' equity (deficit)||55,373||(80,131||)|
|Total liabilities, redeemable convertible preferred stock and stockholders equity (deficit)||$||68,213||$||15,761|
CONDENSED STATEMENT OF OPERATIONS (UNAUDITED)
(In thousands, except per share amounts)
|Research and development||4,407||3,980|
|General and administrative||1,966||810|
|Total operating expenses||6,373||4,790|
|Loss from operations||(6,373||)||(4,531||)|
|Other expense, net||(956||)||(133||)|
|Accretion of redeemable convertible preferred stock to redemption value||$||(180||)||$||(395||)|
|Net loss attributable to common stockholders - basic and diluted||(7,509||)||(5,059||)|
|Net loss per share attributable to common stockholders - basic and diluted||$||(0.76||)||$||(17.09||)|
|Weighted-average number of common shares used in net loss per share attributable to common stockholders - basic and diluted||9,859||296|
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