Genocea Provides Fourth Quarter 2019 Corporate Update
ATLASTM identifies Inhibigenstm that can undermine immunotherapy
Dosed first patient in Part B of GEN-009 neoantigen vaccine Phase 1/2a trial
Progressed GEN-011 neoantigen cell therapy - IND filing expected in Q2 2020
Conference call today at
Genocea presented new inhibigen (inhibitory antigen) data at the
The company also completed patient dosing in Part A of its GEN-009 neoantigen vaccine phase 1/2a trial with no disease recurrence in vaccinated study participants to date. GEN-009 was highly immunogenic and well-tolerated by the entire cohort. Genocea has begun dosing patients for Part B, testing GEN-009 in combination with standard-of-care ICI therapy, with preliminary clinical results expected in Q2/Q3 2020.
Genocea also made important progress developing a robust manufacturing process for GEN-011, an adoptive T cell therapy using T cells derived from peripheral blood against ATLAS-identified neoantigens. The company intends to file an Investigational New Drug Application (IND) for GEN-011 in Q2 2020 with preliminary clinical results expected in 1H 2021.
“Genocea made critical scientific and clinical progress in the last quarter,” said
Genocea also appointed
Fourth Quarter 2019 Financial Results
- Cash position: As of
December 31, 2019, cash and cash equivalents were $40.1 millionversus $26.4 millionas of December 31, 2018.
- Research and Development (R&D) expenses: R&D expenses were
$6.8 millionfor the quarter ended December 31, 2019, compared to $6.3 millionfor the same period in 2018.
- General and Administrative (G&A) expenses: G&A expenses were
$3.0 millionfor the quarter ended December 31, 2019, compared to $2.6 millionfor the same period in 2018.
- Net income/loss: Net loss was
$9.4 millionfor the quarter ended December 31, 2019, compared to a net income of $0.4 millionfor the same period in 2018.
Genocea expects that its existing cash and cash equivalents are sufficient to support its operations into the first quarter of 2021.
Genocea will host a conference call and webcast today at
Genocea’s mission is to conquer cancer by developing personalized cancer immunotherapies in multiple tumor types. Our unique ATLAS™ platform comprehensively profiles each patient’s T cell responses to potential targets, or antigens, on the tumor. ATLAS enables us to optimize the neoantigens for inclusion in our immunotherapies and exclude inhibitory antigens that can exert an immunosuppressive effect. We are advancing two ATLAS-enabled programs: GEN-009, our neoantigen vaccine for which we are conducting a Phase 1/2a clinical trial and expect preliminary clinical results in Q2/Q3 2020, and GEN-011, our neoantigen-specific cell therapy using T cells derived from peripheral blood, for which we intend to file an Investigational New Drug Application in the second quarter of 2020. To learn more, please visit www.genocea.com.
This press release includes forward-looking statements, including statements relating to GEN-009 and GEN-011, within the meaning of the Private Securities Litigation Reform Act. Such forward-looking statements are subject to risks and uncertainties that could cause actual results to differ materially from those expressed or implied in such statements. Genocea cautions that these forward-looking statements are subject to numerous assumptions, risks and uncertainties that change over time. Applicable risks and uncertainties include those identified under the heading "Risk Factors" included in Genocea's Annual Report on Form 10-K for the year ended
CONDENSED CONSOLIDATED BALANCE SHEETS (UNAUDITED)
|December 31, 2019||December 31, 2018|
|Cash and cash equivalents||$||40,127||$||26,361|
|Debt, current and long-term||$||13,407||$||14,822|
|Accounts payable, accrued expenses and other liabilities||11,676||5,486|
|Total liabilities and stockholders’ equity||$||52,611||$||31,115|
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS (UNAUDITED)
(In thousands, except per share data)
|Three Months Ended
|Twelve Months Ended
|Research and development||$||6,817||$||6,259||$||26,952||$||25,209|
|General and administrative||3,045||2,627||12,037||14,309|
|Total operating expenses||9,862||8,886||38,989||39,518|
|Loss from operations||(9,862||)||(8,886||)||(38,989||)||(39,518||)|
|Net income (loss):||$||(9,356||)||$||350||$||(38,950||)||$||(27,811||)|
|Net income (loss) per share - basic and diluted||$||(0.34||)||$||0.03||$||(1.89||)||$||(2.69||)|
|Weighted-average number of common shares used in computing net loss per share||27,620||10,846||20,644||10,321|
Source: Genocea Biosciences, Inc.