Genocea Reports Fourth Quarter and Year-End 2015 Financial Results
- Multiple 2016 clinical milestones for GEN-003 for genital herpes anticipated -
- Cancer vaccine strategy targeting generation of first clinical candidate in 2017 -
"2015 was another year of important progress for our lead product candidate, GEN-003 for genital herpes, and our ATLASTM T cell target discovery platform. In October, we demonstrated significant and durable Phase 2 efficacy for GEN-003, potentially positioning it to become the cornerstone treatment for the millions of people who suffer from genital herpes infections. 2016 will also be a rich year for GEN-003 clinical milestones
with 12-month durability data from the ongoing Phase 2 trial expected later this quarter, virologic and clinical efficacy data from a Phase 2b study expected in the middle and second half of 2016, respectively, and an end-of-Phase 2 meeting with the
2015 Business Highlights and 2016 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 in
Multiple anticipated 2016 clinical milestones for GEN-003
- Phase 2 12-month durability data expected in the first quarter of 2016
- Phase 2b virologic efficacy data expected in mid-2016
- Phase 2b clinical efficacy data expected in second half of 2016
- End-of-Phase 2 meeting with the
U.S. Food and Drug Administrationexpected in 4Q 2016
Later in the first quarter of 2016, the Company expects to report 12-month durability data from the ongoing Phase 2 dose optimization trial. Positive results, if achieved, would represent an improvement to the already-attractive 6-month durability of effect which was confirmed in the fourth quarter of 2015. This data is also expected to provide guidance on the frequency of administration of maintenance therapy with GEN-003.
In the middle of 2016, Genocea expects to report virologic efficacy data from a recently-initiated Phase 2b study. Positive results, if achieved, would confirm the activity of GEN-003 manufactured at commercial scale and are an important step towards the
In the second half of 2016, the Company expects to report clinical efficacy data from this Phase 2b study. This placebo-controlled data represents the first opportunity to measure GEN-003 manufactured at commercial scale against potential Phase 3 endpoints at 6-months after dosing.
The Company also expects to commence a planned Phase 2b antiviral combination study in the middle of 2016. Clinical efficacy data from this trial is expected in the first half of 2017. If GEN-003 is additive to the effect of chronic suppressive oral anti-viral therapy, this would further strengthen GEN-003's value proposition to patients and physicians.
Cancer Vaccine Programs - Developed from Genocea's ATLAS technology platform for better T cell target discovery
- New collaboration with
Memorial Sloan Kettering Cancer Centerannounced in November 2015to identify cancer vaccine candidates
- Results from Dana-Farber collaboration presented as late-breaker at the
Society for Immunotherapy of Cancer(SITC) meeting in November 2015
- Immunotherapy program initiated in 2015 targeting Epstein-Barr Virus
The Company's ATLAS T cell antigen discovery platform makes no assumptions about which cancer antigens are meaningful and which are not. It instead takes a panoramic view of the actual T cell responses of human subjects to any possible T cell target in a cancer. When applied across large diverse populations against common tumor-associated antigens, ATLAS could discover better targets for inclusion in general cancer vaccines. When applied to an individual's response to their own cancer neoantigens, ATLAS could enable better personalized cancer vaccines, either as standalone therapies or in combination with other immunotherapies like checkpoint inhibitors.
The core strength of ATLAS is that it does not use predictive algorithms to identify antigens. It discovers clinically relevant T cell antigens associated with protective responses from comprehensive cell-based assays of actual human T cell responses.In contrast to predictive approaches to vaccine antigen selection, Genocea believes that ATLAS has a number of critical benefits, including that it potentially can find antigens to which patients are actually responding, distinguish between clinically relevant and immuno-dominant responses, identify separately targets of CD4+ and CD8+ T cells and is not HLA-limited. Genocea believes better vaccine targets may enable more efficacious and safer cancer vaccines and also the stratification of patients who may be best-suited to respond to immuno-oncology therapy or therapy combinations.
Memorial Sloan Kettering Cancer Center Collaboration
Dana Farber Cancer Institute Collaboration
Epstein-Barr Virus Program
Genocea expects to announce further data from its ongoing immuno-oncology collaborations in 2016 and hopes to commence clinical trials with a cancer vaccine in 2017. For EBV, Genocea expect to have completed its initial ATLAS screening studies and to have identified a number of antigen targets for further research and pre-clinical development this year.
GEN-004 - Vaccine for the prevention of infections by all serotypes of pneumococcus.
- Reported top-line results from Phase 2a clinical trial in
- Development suspended pending review of potential paths forward
Fourth Quarter 2015 Financial Results
- Cash Position: Cash, cash equivalents and investments as of
December 31, 2015were $106.4compared to $112.5 millionas of September 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
December 31, 2015decreased $2.1 million, to $6.5 million, from the same period in 2014, reflecting lower clinical and manufacturing costs for GEN-003 and GEN-004 due to the timing of clinical trial-related activities, including the suspension of development of GEN-004. These lower costs were partially offset by higher personnel and lab-related costs related to Genocea's cancer vaccine programs and preclinical pipeline.
- General and Administrative (G&A) Expenses: G&A expenses for the fourth quarter of 2015 were $3.8 million, compared to $2.6 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.
- Net Loss: Net loss was $10.3 million for the quarter ended
December 31, 2015, compared to a net loss of $11.7 million for the same period in 2014.
Full Year 2015 Financial Results
- Cash Position: Cash, cash equivalents and investments as of December 31, 2015 were
$106.4 million, compared to $47.1 million as of December 31, 2014. The increase was due to two follow-on offerings completed during the year with aggregate net proceeds of approximately $95.2 million, along with additional net borrowings of $4.7 millionfrom a debt amendment executed in the fourth quarter of 2015 offset by cash used in Genocea's operations and for capital expenditures.
- R&D Expenses: R&D expenses for the year ended
December 31, 2015were $28.0 million, compared to $23.7 millionfor the same period in 2014, reflecting higher personnel costs and lab related costs both of which supported the continued advancement of the Company's clinical programs along with increasing investments in Genocea's cancer vaccine programs and preclinical pipeline.
- G&A Expenses: G&A expenses were $14.0 million for the year ended
December 31, 2015, compared to $9.7 million for the same period in 2014, reflecting additional personnel costs and depreciation expense supporting overall Company growth.
- Net Loss: Net loss was $42.5 million for the year ended
December 31, 2015, compared to a net loss of $35.3 million for the same period in 2014.
Genocea will host a conference call and webcast today at
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 immunity. 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 (development suspended), 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.
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 oncology vaccine and immunotherapy product candidates; 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 CONSOLIDATED BALANCE SHEETS (UNAUDITED)|
|Cash, cash equivalents and investments||$||106,432||$||47,079|
|Accrued expenses and other liabilities||4,012||2,839|
|Total liabilities and stockholders' equity||$||112,142||$||50,332|
|* Includes |
|(In thousands, except per share amounts)|
|CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS (UNAUDITED)|
|Three months ended||Twelve months ended|
|Research and development||6,513||8,654||28,049||23,727|
|General and administrative||3,781||2,580||13,987||9,747|
|Total operating expenses||10,294||11,234||42,036||33,474|
|Loss from operations||(10,073||)||(10,926||)||(41,366||)||(33,166||)|
|Other expense, net||(241||)||(724||)||(1,117||)||(2,130||)|
|Accretion of redeemable convertible preferred stock to redemption value||-||-||-||(180||)|
|Net loss attributable to common stockholders||(10,314||)||(11,650||)||$||(42,483||)||$||(35,476||)|
|Net loss per share attributable to common stockholders - basic and diluted||$||(0.37||)||$||(0.66||)||$||(1.74||)||$||(2.27||)|
|Weighted-average number of common shares used in net loss per share attributable to common stockholders - basic and diluted||28,118||17,696||24,460||15,618|
Liz Bryan Spectrum Science Communications, Inc.O: 202-955-6222 firstname.lastname@example.org For investors: Jonathan Poole Genocea Biosciences, Inc.O: 617-876-8191 email@example.com
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