Genocea Reports First Quarter 2015 Financial Results
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. >
-
Completed enrollment ahead of schedule in
January 2015 - Top-line results expected late in the second quarter of 2015
- GEN-003 boosted neutralizing antibody titers against HSV-2 and HSV-1 in Phase 1/2a trial
In
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.
In
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
-
Completed enrollment in
April 2015 - Top-line results expected in the fourth quarter of 2015
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
Completed
- GEN-003 program accelerated
- Two new research programs planned for 2015
- Strong balance sheet provides foundation for ongoing business development activities
In
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
Appointed
Genocea announced in
First Quarter 2015 Financial Results & Financial Guidance
-
Cash Position: Cash, cash equivalents and marketable
securities as of March 31, 2015 were $84.5 million, compared to $47.1
million as of December 31, 2014. The increase was as a result of
Genocea's public offering in
March 2015 which raised net proceeds of$48.4 million . Genocea expects that these funds will be sufficient to fund its operating expenses and capital expenditure requirements through the third quarter of 2016. -
Research and Development (R&D) Expenses: R&D expenses for
the quarter ended
March 31, 2015 were$8.5 million , compared to$4.4 million for the same period in 2014, reflecting higher personnel costs, the manufacturing and clinical trial costs associated with the continued advancement of GEN-003, increased clinical trial costs associated with the ongoing Phase 2a clinical trial for GEN-004 and investments in Genocea's pre-clinical pipeline. -
General and Administrative (G&A) Expenses: G&A expenses for
the quarter ended
March 31, 2015 were $3.4 million, compared to $2.0 million for the same period in 2014 reflecting higher personnel costs and increased costs to support Genocea's operations as a public company. - Net Loss: Net loss was $12.1 million for the first quarter of 2015, compared to a net loss of $7.3 million for the same period in 2014.
Conference Call
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.
About Genocea
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) (In thousands) |
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2015 | 2014 | ||||||||
Cash, cash equivalents and marketable securities | $ | 84,493 | $ | 47,079 | |||||
Other assets | 3,923 | 3,352 | |||||||
Total assets | $ | 88,416 | $ | 50,431 | |||||
Note payable | $ | 11,582 | $ | 11,488 | |||||
Accounts payable | 2,758 | 2,692 | |||||||
Accrued expenses | 3,262 | 2,486 | |||||||
Other liabilities | 1,068 | 1,258 | |||||||
Total liabilities | 18,670 | 17,924 | |||||||
Stockholders' equity | 69,746 | 32,507 | |||||||
Total liabilities, and stockholders' equity | $ | 88,416 | $ | 50,431 |
(In thousands, except per share amounts) CONDENSED STATEMENTS OF OPERATIONS (UNAUDITED) |
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Three months ended
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2015 | 2014 | |||||||||
Grant revenue | $ | 121 | $ | - | ||||||
Operating expenses: | ||||||||||
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 | ) | ||||||
Net loss | $ | (12,084 | ) | $ | (7,329 | ) | ||||
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 |
For media:
mlustig@spectrumscience.com
or
For
investors:
jonathan.poole@genocea.com
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