Genocea Reports Third Quarter 2015 Financial Results
- Company Reports Recent Milestones and Announces Expansion of ATLASTM Technology into Immuno-Oncology -
- Conference Call and Webcast Scheduled for
"In early October, we reported positive six-month durability data for
GEN-003 which further support its potential to serve as a cornerstone
therapy for genital herpes infections with convenient, long-term disease
control. We look forward to reporting 12-month data from this ongoing
trial in the first quarter of 2016 and to our end of Phase 2 meeting
with the
Business Highlights and Anticipated Milestones
GEN-003 - Immunotherapy for treatment of genital herpes in Phase 2
development. Greater than
- Reported positive results six months after dosing from ongoing Phase 2 dose optimization trial
- 12-month data expected in the first quarter of 2016
-
End of Phase 2 meeting with
U.S. Food and Drug Administration expected in late 2016
On
In a planned secondary analysis to assess the impact on genital lesion rates, GEN-003 demonstrated sustained and statistically significant reductions from baseline in five of six dose groups ranging from 43 to 69 percent. In addition, the proportion of patients receiving GEN-003 who were lesion-free at six months after dosing ranged from approximately 30 to 50 percent, similar to results reported in Phase 3 clinical trials with oral antiviral therapies. A further secondary analysis measuring the time to first recurrence after completion of dosing showed a range of 152 days to greater than 180 days among dose groups. The Phase 2 trial continues to show that GEN-003 is safe and well tolerated by patients, with no serious adverse events related to the vaccine.
GEN-004 - Vaccine for the prevention of infections by all serotypes of pneumococcus.
- Reported top-line results from Phase 2a clinical trial in October
- Development suspended pending review of potential paths forward
On
ATLAS technology platform - Expansion into immuno-oncology
-
Results from Dana-Farber collaboration to be presented at SITC
on
November 6 ; collaboration ongoing -
New collaboration with
Memorial Sloan Kettering Cancer Center announced today - ATLAS's ability to identify T cell antigens may unlock new cancer vaccines
- Immunotherapy program initiated targeting Epstein-Barr Virus
Genocea was founded to create T cell-directed immunotherapies and vaccines using ATLAS, a unique platform for profiling large and diverse patient populations to find the T cell antigens driving protective responses. The Company believes that data reported to date for GEN-003 represents the first evidence of efficacy by an immunotherapy built around new T cell targets for an infectious disease. Building on the success of ATLAS in genital herpes, Genocea initiated a research collaboration with Dana-Farber in 2014 to apply ATLAS in immuno-oncology. This collaboration centered on the potential of ATLAS to identify patterns of T cell response in cancer patients receiving checkpoint inhibitor therapy.
ATLAS makes no assumptions about which cancer antigens are meaningful and which are not. It instead takes a panoramic view of a large, diverse population of human subjects and reveals clinically relevant T cell antigens of protective responses. In contrast to other high-throughput predictive tools currently being applied in oncology drug discovery, Genocea believes that ATLAShas a number of critical benefits, including that it potentially:
- Can find antigens to which patients are actually responding;
- Can distinguish between clinically relevant and immuno-dominant responses;
- Can identify separately targets of CD4+ and CD8+ T cells;
- Is not HLA-limited.
These benefits may enable smarter identification of cancer antigens for cancer vaccines and smarter identification of patients best suited to immuno-oncology therapy or therapy combinations.
Dana-Farber Collaboration
In this pilot study, funded by the
The collaboration with Dana-Farber is ongoing as Genocea continues to analyze more blood samples to characterize T cell response profiles that may be prognostic of CPI efficacy, and to identify T cell antigens that may be included in novel immunotherapies.
Memorial Sloan Kettering Cancer Center Collaboration
The Company today announced a collaboration with
The goals of the collaboration are to identify signatures of T cell
response in cancer patients associated with response or non-response to
CPI therapy and to discover new T cell cancer vaccine antigens. ATLAS
will be used in conjunction with Memorial Sloan Kettering's
patient-specific cancer neoantigen sequences and blood samples from the
same cancer patients. This new collaborative work will be led by
investigators
Epstein-Barr Virus Immunotherapy Program Initiated
Genocea has commenced a new program focused on Epstein-Barr Virus (EBV). EBV infection has been linked to cancers with high unmet needs such as non-Hodgkin's lymphoma, nasopharyngeal carcinoma and gastric carcinoma. We believe the ATLASplatform is highly suited to the creation of a new immunotherapy for EBV given that T cell responses are understood to be crucial for protection against EBV. Furthermore, EBV is part of the herpesvirus family, in which Genocea has deep experience through its development of GEN-003.
Completed
- Funding expected to be sufficient to complete GEN-003 Phase 2 program
- Strengthened balance sheet provides foundation for ongoing business development activities
In
Third Quarter 2015 Financial Results & Financial Guidance
- Cash Position: Cash, cash equivalents and investments as of September 30, 2015 were $112.5 million, compared to $74.6 million as of June 30, 2015. Genocea expects that these funds 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
September 30, 2015 were unchanged at$6.1 million compared to the same period in 2014, reflecting higher personnel costs and increased lab-related costs offset by reductions in manufacturing and licensing fees related to the commencement of GEN-003 and GEN-004 clinical trials. We continue to make investments in Genocea's preclinical pipeline, which offset lower R&D expense for our GEN-003 and GEN-004 programs on a quarter over quarter basis. -
General and Administrative (G&A) Expenses: G&A expenses for
the quarter ended
September 30, 2015 were $3.6 million, compared to $2.8 million for the same period in 2014. The increase reflects higher personnel costs and depreciation expense, both of which support Genocea's expanding R&D operations and the demands of operating as a public company. - Net Loss: Net loss was $9.8 million for the third quarter of 2015, compared to a net loss of $9.2 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 60192429. 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 all serotypes of pneumococcus, and earlier-stage programs in chlamydia, genital herpes 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 ability of ATLAS to identify promising product
candidates in oncology; 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
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| CONDENSED BALANCE SHEETS (UNAUDITED) | ||||||||||
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| 2015 | 2014* | |||||||||
| Cash, cash equivalents and investments | $ | 112,545 | $ | 47,079 | ||||||
| Other assets | 5,335 | 3,253 | ||||||||
| Total assets | $ | 117,880 | $ | 50,332 | ||||||
| Debt, current and long-term | $ | 11,658 | $ | 11,389 | ||||||
| Accounts payable | 1,731 | 2,692 | ||||||||
| Accrued expenses | 4,928 | 2,486 | ||||||||
| Other liabilities | 678 | 1,258 | ||||||||
| Total liabilities | 18,995 | 17,825 | ||||||||
| Stockholders' equity | 98,885 | 32,507 | ||||||||
| Total liabilities and stockholders' equity | $ | 117,880 | $ | 50,332 | ||||||
* Includes
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| CONDENSED STATEMENTS OF OPERATIONS (UNAUDITED) | ||||||||||||||||
| (In thousands, except per share amounts) | ||||||||||||||||
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Three months ended
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Nine months ended
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| 2015 | 2014 | 2015 | 2014 | |||||||||||||
| Grant revenue |
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$ - |
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$ - | ||||||||||||
| Operating expenses: | ||||||||||||||||
| Research and development | 6,058 | 6,115 | 21,536 | 15,073 | ||||||||||||
| General and administrative | 3,645 | 2,843 | 10,206 | 7,167 | ||||||||||||
| Total operating expenses | 9,703 | 8,958 | 31,742 | 22,240 | ||||||||||||
| Loss from operations | (9,490) | (8,958) | (31,293) | (22,240) | ||||||||||||
| Other expense, net | (281) | (213) | (876) | (1,406) | ||||||||||||
| Net loss |
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| Accretion of redeemable convertible preferred stock to redemption value | - | - | - | (180) | ||||||||||||
| Net loss attributable to common stockholders |
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| Net loss per share attributable to common stockholders - basic and diluted |
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| Weighted-average number of common shares used in net loss per share attributable to common stockholders - basic and diluted | 26,610 | 17,465 | 23,228 | 14,918 | ||||||||||||
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