Genocea Provides Corporate Update, Including First-Quarter 2019 Financial Results
Company anticipates presenting first GEN-009 immunogenicity data at
Conference call today at
“As we say at Genocea, “targets matter,” and we are advancing two programs to demonstrate that target – or antigen – selection plays a large, and underappreciated, role in driving immunotherapy efficacy,” said
Recent Operational Highlights
- Announced a clinical milestone in early January, dosing the first patients and completing enrollment in Part A of the Phase 1/2a clinical trial for GEN-009. The first immunogenicity data from this study are expected to be presented at this year’s meeting of the
American Society of Clinical Oncology( ASCO2019) in early June.
- Completed a private placement financing in mid-February, the first closing of which resulted in gross proceeds of
$15.0 million(before deal-related expenses).
- Strengthened senior management team, appointing
Diantha Duvallas Chief Financial Officer in early March.
- Presented additional ATLAS data at the 2019 Annual Meeting of the
American Association for Cancer Research(AACR 2019) in early April. The poster highlighted the potential use of ATLAS as a tool to predict the advanced melanoma patients for whom checkpoint therapy might prove successful.
First-Quarter 2019 Financial Results
- Cash position: As of
March 31, 2019, cash and cash equivalents were $29.0 millionversus $26.4 millionas of December 31, 2018.
- Research and Development (R&D) expenses: R&D expenses were
$6.5 millionfor the quarter ended March 31, 2019, compared to $7.3 millionfor the same period in 2018.
- General and Administrative (G&A) expenses: G&A expenses were
$3.0 millionfor the quarter ended March 31, 2019, compared to $3.1 millionfor the same period in 2018.
- Net loss: Net loss was
$15.6 millionfor the quarter ended March 31, 2019, compared to a net loss of $15.9 millionfor the quarter ended March 31, 2018.
Genocea expects that its existing cash and cash equivalents are sufficient to support its operations into the first quarter of 2020.
Genocea will host a conference call and webcast today at
Genocea is a biopharmaceutical company developing personalized cancer immunotherapies. Our unique ATLAS™ technology platform allows us to identify immunotherapy targets based on each person’s tumor antigen-specific T cell responses. Using ATLAS, we can both optimize neoantigens for inclusion in our immunotherapies and exclude so-called “inhibitory” antigens that appear to exert an immunosuppressive effect on the patient. We are advancing complementary programs built from ATLAS insights: GEN-009, our neoantigen vaccine candidate for which we are conducting a Phase 1/2a clinical trial across a variety of solid tumor types, and GEN-011, our neoantigen-specific adoptive T cell therapy, for which we intend to file an Investigational New Drug Application in the first half of 2020. To learn more, please visit www.genocea.com
This press release includes forward-looking statements, including statements relating to the near-term milestones for GEN-009 and GEN-011 and the period for which existing cash will be able to fund operations, within the meaning of the Private Securities Litigation Reform Act. Such forward-looking statements are subject to risks and uncertainties that could cause actual results to differ materially from those expressed or implied in such statements. Genocea cautions that these forward-looking statements are subject to numerous assumptions, risks and uncertainties that change over time. Applicable risks and uncertainties include those identified under the heading "Risk Factors" included in Genocea's Annual Report on Form 10-K for the year ended
CONDENSED CONSOLIDATED BALANCE SHEETS (UNAUDITED)
|March 31, 2019||December 31, 2018|
|Cash and cash equivalents||$||29,038||$||26,361|
|Debt, current and long-term||$||14,122||$||14,822|
|Accounts payable, accrued expenses and other liabilities||6,208||5,486|
|Total liabilities and stockholders’ equity||$||35,824||$||31,115|
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS (UNAUDITED)
(In thousands, except per share data)
|Three months ended March 31,|
|Research and development||$||6,460||$||7,275|
|General and administrative||3,017||3,109|
|Total operating expenses||9,477||10,384|
|Loss from operations||(9,477||)||(10,384||)|
|Change in fair value of warrants||(5,787||)||(5,298||)|
|Interest expense, net||(303||)||(208||)|
|Total other expense||(6,090||)||(5,506||)|
|Net loss per share - basic and diluted||$||(0.15||)||$||(0.22||)|
|Weighted-average number of common shares used in computing net loss per share||101,700||71,238|
Source: Genocea Biosciences, Inc.