Genocea Provides First Quarter 2020 Corporate Update
Clinical stage programs GEN-009 and GEN-011 continue to advance
Anticipate GEN-011 IND filing in Q2
Expect GEN-009 Phase 1/2a Part B readout in Q3
GEN-011 Virtual Symposium planned for
Conference call today at
Genocea remains on track with its two differentiated clinical stage programs - GEN-009 (neoantigen vaccine) and GEN-011 (neoantigen cell therapy). The GEN-009 phase 1/2a clinical trial has reached sufficient enrollment for Part B of the study, which evaluates GEN-009 in combination with standard-of-care ICI therapy. The company anticipates preliminary clinical results in Q3 2020. Genocea also intends to file an Investigational New Drug Application (IND) for GEN-011 later this quarter with preliminary clinical results expected in 1H 2021.
Genocea will host a GEN-011 virtual symposium on
“Over the last quarter, we have conducted our GEN-009 clinical program and prepared GEN-011 for IND filing as planned,” said
First Quarter 2020 Financial Results
- Cash position: As of
March 31, 2020, cash and cash equivalents were $26.5 millionversus $40.1 millionas of December 31, 2019.
- Research and Development (R&D) expenses: R&D expenses were
$10.0 millionfor the quarter ended March 31, 2020, compared to $6.5 millionfor the same period in 2019.
- General and Administrative (G&A) expenses: G&A expenses were
$3.4 millionfor the quarter ended March 31, 2020, compared to $3.0 millionfor the same period in 2019.
- Net loss: Net loss was
$12.9 millionfor the quarter ended March 31, 2020, compared to $15.6 millionfor the same period in 2019.
Genocea expects that its existing cash and cash equivalents are sufficient to support its operations into the first quarter of 2021.
Genocea will host a conference call and webcast today at
Genocea’s mission is to conquer cancer by developing personalized cancer immunotherapies in multiple tumor types. Our unique ATLAS™ platform comprehensively profiles each patient’s T cell responses to potential targets, or antigens, on the tumor. ATLAS enables us to optimize the neoantigens for inclusion in our immunotherapies and exclude inhibitory antigens that can exert an immunosuppressive effect. We are advancing two ATLAS-enabled programs: GEN-009, our neoantigen vaccine for which we are conducting a Phase 1/2a clinical trial and expect preliminary clinical results in the third quarter of 2020, and GEN-011, our neoantigen-specific cell therapy using T cells derived from peripheral blood, for which we intend to file an Investigational New Drug Application in the second quarter of 2020. To learn more, please visit www.genocea.com.
This press release includes forward-looking statements, including statements relating to GEN-009 and GEN-011, within the meaning of the Private Securities Litigation Reform Act. Such forward-looking statements are subject to risks and uncertainties that could cause actual results to differ materially from those expressed or implied in such statements. Genocea cautions that these forward-looking statements are subject to numerous assumptions, risks and uncertainties that change over time. Applicable risks and uncertainties include those identified under the heading "Risk Factors" included in Genocea's Annual Report on Form 10-K for the year ended
(Tables to follow)
CONDENSED CONSOLIDATED BALANCE SHEETS (UNAUDITED)
|Cash and cash equivalents||$||26,509||$||40,127|
|Debt, current and long-term||$||13,515||$||13,407|
|Accounts payable, accrued expenses and other liabilities||16,959||11,676|
|Total liabilities and stockholders’ equity||$||45,192||$||52,611|
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS (UNAUDITED)
(In thousands, except per share data)
|Three Months Ended
|Research and development||$||9,987||$||6,460|
|General and administrative||3,388||3,017|
|Total operating expenses||13,375||9,477|
|Loss from operations||(13,375||)||(9,477||)|
|Other income (expense)||522||(6,090||)|
|Net loss per share - basic and diluted||$||(0.46||)||$||(1.22||)|
|Weighted-average number of common shares used in computing net loss per share||28,141||12,713|
Source: Genocea Biosciences, Inc.