Genocea Provides First Quarter 2021 Corporate Update
GEN-011 and GEN-009 immuno-oncology programs continue to advance
Research on Inhibigens™ and SARS-CoV-2 continues to progress
Conference call today at
“Genocea continues to accumulate evidence that our ATLAS™ platform may enable immunotherapies that preferentially attack the surface-presented antigens driving anti-tumor responses or as we say, ‘Targets Matter’,” said
GEN-011 Phase 1/2a clinical trial (the “TITAN study”)
- GEN-011 is in development to treat checkpoint inhibitor-refractory patients. Genocea believes using patient T cells taken from easily accessible peripheral blood and expanding the T cells only on tumor neoantigens prioritized by our ATLAS platform may give GEN-011 efficacy, accessibility and cost advantages over other T cell therapies. The TITAN study is designed to explore safety, biomarkers of activity and anti-tumor efficacy. During the first quarter, Genocea continued to add clinical sites and accrue patients. The company expects to have initial efficacy data from a patient subset late in the fourth quarter of 2021 or the first quarter of 2022.
GEN-009 Phase 1/2a clinical trial
- The Company will provide long-term follow-up clinical and immunogenicity data from the ongoing Phase 1/2a clinical study at the
American Society of Clinical Oncology(“ASCO”) 2021 Annual Meeting from June 4 - June 8.
- At the
American Association for Cancer Research(“AACR”) Annual Meeting 2021 in April, the Company presented novel preclinical Inhibigen data highlighting that the presence of a single Inhibigen in an otherwise protective immunotherapy can completely reverse the therapy’s intended anti-tumor responses and the Inhibigen effect can be seen as early as 4 days post-dosing.
- The Company continues its SARS-CoV-2 research efforts to identify conserved antigens of protective T cell responses that may enable a next-generation vaccine protecting against a wide range of strains.
Other business updates
Strengthened executive leadership team
- Genocea appointed Jacquelyn Sumer as Chief Legal and Compliance Officer. Jackie brings over fifteen years of legal experience, including roles at several biopharmaceutical companies with a focus in oncology and cell therapy experience development and commercialization.
Financial and other updates
First quarter 2021 financial results
- Cash position: As of
March 31, 2021, cash and cash equivalents were $66.0 millioncompared to $79.8 millionas of December 31, 2020.
- Research and Development (R&D) expenses: R&D expenses were
$8.8 millionfor the quarter ended March 31, 2021, compared to $10.0 millionfor the same period in 2020.
- General and Administrative (G&A) expenses: G&A expenses were
$3.7 millionfor the quarter ended March 31, 2021, compared to $3.4 millionfor the same period in 2020.
- Net loss: Net loss was
$12.0 millionfor the quarter ended March 31, 2021, compared to $12.9 millionfor the same period in 2020.
February 2021, the Company entered into an agreement with Silicon Valley Bankfor a $10 million term loan. The proceeds from the loan were used to repay the Company’s outstanding loan from Hercules Capital, Inc., and for general corporate purposes.
- Genocea’s operating plan extends its cash runway to the end of 2022.
Genocea will host a conference call and webcast today at
Genocea’s mission is to identify the right tumor targets to develop life-changing immunotherapies for people suffering from cancer. Our proprietary ATLAS™ platform comprehensively profiles each patient’s T cell responses to potential targets, or antigens, on that patient’s tumor. ATLAS zeroes in on both antigens that activate anti-tumor T cell responses and inhibitory antigens, InhibigensTM, that drive pro-tumor immune responses. We are advancing two ATLAS-enabled programs: GEN-009, our neoantigen vaccine for which we are conducting a Phase 1/2a clinical trial and GEN-011, our adoptive T cell therapy comprising neoantigen-targeted peripheral cells for which we are conducting a Phase 1/2a clinical trial. In addition to our two clinical programs, we are conducting research in several areas where we believe ATLAS could be a key tool in optimizing antigen selection for therapies across a number of diseases. To learn more, please visit https://www.genocea.com.
This press release includes forward-looking statements related to GEN-009, GEN-011 and research updates within the meaning of the Private Securities Litigation Reform Act. Such forward-looking statements are subject to risks and uncertainties that could cause actual results to differ materially from those expressed or implied in such statements. Genocea cautions that these forward-looking statements are subject to numerous assumptions, risks and uncertainties that change over time. Applicable risks and uncertainties include those identified under the heading "Risk Factors" included in Genocea's Annual Report on Form 10-K for the year ended
CONDENSED CONSOLIDATED BALANCE SHEETS (UNAUDITED)
|Cash and cash equivalents||$||66,035||$||79,769|
|Property and equipment, net||4,853||5,123|
|Right of use assets||8,831||9,308|
|Accounts payable and accrued expenses||$||5,627||$||7,878|
|Debt, current and long-term||9,649||13,862|
|Total liabilities and stockholders’ equity||$||83,938||$||98,493|
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS (UNAUDITED)
(In thousands, except per share data)
|Three Months Ended
|Research and development||$||8,751||$||9,987|
|General and administrative||3,671||3,388|
|Total operating expenses||12,422||13,375|
|Loss from operations||(12,422||)||(13,375||)|
|Net loss per share:|
|Weighted-average number of shares used in computing net loss per share:|
Source: Genocea Biosciences, Inc.