Genocea Reports Second Quarter 2015 Financial Results
"We were extremely pleased to report positive top-line results in May
from our Phase 2 dose optimization trial of GEN-003, our immunotherapy
against genital herpes, which improved upon the already attractive
efficacy profile from our prior Phase 1/2a trial," said
Business Highlights and Anticipated Milestones
GEN-003 - Immunotherapy for treatment of genital herpes in Phase 2
development. >
-
Reported positive top-line data from Phase 2 dose optimization
trial in
May 2015 - 6-month Phase 2 results expected in fourth quarter of 2015
In
Genocea anticipates reporting 6-month Phase 2 dose optimization results in the fourth quarter of 2015. The Company hopes that this data will confirm the 6-month durability of reduction in the viral shedding and genital lesion rates from baseline which was demonstrated in the prior Phase 1/2a trial and which has been established in company-sponsored market research to be highly attractive to patients and physicians.
GEN-004 - Vaccine for the prevention of infections by all
serotypes of pneumococcus. Potentially disruptive to approximately
- Phase 2a challenge study efficacy results expected in the fourth quarter of 2015
Proof-of-efficacy results from the ongoing Phase 2a trial evaluating the impact of GEN-004 on nasopharyngeal colonization by pneumococcus in healthy adults are expected in the fourth quarter of 2015.
Existing vaccines for pneumococcus command approximately a
Completed
- Funding expected to be sufficient to complete GEN-003 Phase 2 program
- Strengthened balance sheet provides foundation for ongoing business development activities
In
The Company believes this financing will enable it to complete its GEN-003 Phase 2 program and continue to advance GEN-004 through clinical development and to progress ongoing and new research programs towards the filing of Investigational New Drug applications.
Second Quarter 2015 Financial Results & Financial Guidance
-
Cash Position: Cash, cash equivalents and marketable
securities as of June 30, 2015 were $74.6 million, compared to $84.5
million as of March 31, 2015. Genocea expects that these funds,
together with the net proceeds of approximately
$47.0 million from the recent public offering, will be sufficient to fund its operating expenses and capital expenditure requirements into the second half of 2017. -
Research and Development (R&D) Expenses: R&D expenses for
the quarter ended
June 30, 2015 were$7.0 million , compared to$4.6 million for the same period in 2014, reflecting higher personnel costs, increased clinical trial costs associated with the continued advancement of GEN-003 and 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
June 30, 2015 were $3.2 million, compared to $2.4 million for the same period in 2014 reflecting higher personnel costs to support Genocea's expanding R&D operations and to meet the demands of operating as a public company. - Net Loss: Net loss was $10.3 million for the second quarter of 2015, compared to a net loss of $7.1 million for the same period in 2014.
Conference Call
Genocea will host a conference call and
webcast today at 9:00 a.m. ET. The conference call may be accessed by
dialing (844) 826-0619 for domestic participants and (315) 625-6883 for
international callers and referencing the conference ID number 87463451.
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-enabled product candidates includes GEN-003 for
genital herpes, GEN-004 for the prevention of infection by more than 90
serotypes of pneumococcus, and earlier-stage programs in chlamydia,
genital herpes prophylaxis and malaria. We are also investigating the
application of ATLAS™ to immuno-oncology target discovery. 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, timing 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
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Cash, cash equivalents and marketable securities | $ | 74,595 | $ | 47,079 | |||
Other assets | 4,121 | 3,253 | |||||
Total assets | $ | 78,716 | $ | 50,332 | |||
Accounts payable | $ | 1,411 | $ | 2,692 | |||
Accrued expenses | 4,160 | 2,486 | |||||
Long term debt | 11,564 | 11,389 | |||||
Other liabilities | 919 | 1,258 | |||||
Total liabilities | 18,054 | 17,825 | |||||
Stockholders' equity | 60,662 | 32,507 | |||||
Total liabilities, and stockholders' equity | $ | 78,716 | $ | 50,332 | |||
* Includes
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Three months ended
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Six months ended
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2015 |
2014 |
2015 |
2014 |
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Grant revenue | $ | 115 | $ | - | $ | 236 | $ | - | |||||||||
Operating expenses: | |||||||||||||||||
Research and development | 6,969 | 4,551 | 15,478 | 8,958 | |||||||||||||
General and administrative | 3,172 | 2,358 | 6,561 | 4,324 | |||||||||||||
Total operating expenses | 10,141 | 6,909 | 22,039 | 13,282 | |||||||||||||
Loss from operations | (10,026 | ) | (6,909 | ) | (21,803 | ) | (13,282 | ) | |||||||||
Other expense, net | (288 | ) | (237 | ) | (595 | ) | (1,193 | ) | |||||||||
Net loss |
$ |
(10,314 |
) | $ | (7,146 | ) | $ | (22,398 | ) | $ | (14,475 | ) | |||||
Accretion of redeemable convertible |
- | - | - | (180 | ) | ||||||||||||
Net loss attributable to common |
$ | (10,314 | ) | $ | (7,146 | ) | $ | (22,398 | ) | $ | (14,655 | ) | |||||
Net loss per share attributable to |
$ | (0.43 | ) | $ | (0.41 | ) | $ | (1.04 | ) | $ | (1.08 | ) | |||||
Weighted-average number of common shares |
24,154 | 17,346 | 21,510 | 13,623 | |||||||||||||
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For media:
mlustig@spectrumscience.com
or
For
investors:
jonathan.poole@genocea.com
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