Genocea Reports Second Quarter 2018 Financial and Operating Results
Neoantigen vaccine program GEN-009 Phase 1/2a clinical trial underway
ATLAS™ platform continues to stand apart from in silico methods of neoantigen identification
Conference call today at
“We’re proud to announce that we have just initiated the Phase 1/2a clinical trial for GEN-009, our lead neoantigen vaccine candidate,” said
Recent Milestones & Events
April 2018: Genocea scientists presented data at the 2018 Annual Meeting of the American Association for Cancer Research(AACR) further highlighting the advantages of its ATLAS platform over in silico methods in identifying both neoantigens for vaccine inclusion and “inhibitory” neoantigens for exclusion and detailing the development of a novel model to study the mechanism of inhibitory antigens identified by ATLAS. April 2018: Genocea filed an Investigational New Drug (IND) application with the U.S. Food and Drug Administration( FDA) to begin clinical development of GEN-009. May 2018: Genocea announced the acceptance of the GEN-009 IND by the FDA. Genocea is currently conducting a Phase 1/2a clinical trial for GEN-009 in patients with a variety of tumor types and expects to report top-line immune response data from the initial patient cohort in the first half of 2019.
Second Quarter 2018 Financial Results
- Cash Position: As of
June 30, 2018, cash and cash equivalents were $44.2 millioncompared to $12.3 millionas of December 31, 2017.
- Research and Development (R&D) Expenses: R&D expenses were
$5.3 millionfor the quarter ended June 30, 2018, compared to $11.4 millionfor the same period in 2017. This decrease was largely due to reduced headcount, external development, lab, clinical, and other R&D costs.
- General and Administrative (G&A) Expenses: G&A expenses were
$4.5 millionfor the quarter ended June 30, 2018, compared to $3.6 millionfor the same period in 2017. This increase was primarily due to increased consulting and professional services costs, offset by reduced compensation and benefits costs.
- Other Income (Expense): Other Income for the quarter ended
June 30, 2018was $5.4 millioncompared to Other Expense of $0.4 millionfor the same period in 2017. Other Income for the second quarter of 2018 is primarily comprised of the non-cash change in fair value of warrants to purchase shares of Genocea common stock.
- Net Loss: Net loss was
$4.4 millionfor the quarter ended June 30, 2018, compared to a net loss of $15.4 millionfor quarter ended June 30, 2017.
Genocea’s financial guidance is unchanged; the company continues to expect that its existing cash and cash equivalents are sufficient to support its operating expenses and capital expenditure requirements into the fourth quarter of 2019.
During the second quarter, under its existing at-the-market equity offering program (ATM), Genocea sold an aggregate of 3.5 million shares of its common stock, receiving approximately
Also during the second quarter, Genocea amended its loan and security agreement with
Genocea continues to explore strategic alternatives for GEN-003, its Phase 3-ready investigational immunotherapy for the treatment of genital herpes.
Genocea will host a conference call and webcast today at
Genocea's mission is to help conquer cancer by designing and delivering targeted vaccines and immunotherapies. While traditional immunotherapy discovery methods have largely used predictive methods to propose T cell targets, or antigens, Genocea has developed ATLAS™, its proprietary technology platform, to identify clinically relevant antigens of T cells based on actual human immune responses. Genocea is using ATLAS in immuno-oncology applications to develop cancer vaccines and immunotherapies. Genocea is currently studying the safety, immunogenicity, and efficacy of its lead neoantigen cancer vaccine, GEN-009, in a Phase 1/2a clinical trial. For more information, please visit www.genocea.com.
This press release includes forward-looking statements, including statements relating to the expected clinical development of GEN-009, the rate of cash utilized by Genocea in its business, and the period for which existing cash will be able to fund such operation, 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)
|June 30, 2018||December 31, 2017|
|Cash and cash equivalents||$||44,215||$||12,273|
|Debt, current and long-term||$||14,468||$||14,311|
|Accrued expenses and other liabilities||3,136||5,711|
|Stockholders' equity (deficit)||13,865||(6,050||)|
|Total liabilities and stockholders’ equity (deficit)||$||49,040||$||17,488|
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS (UNAUDITED)
(In thousands, except per share amounts)
|Three Months Ended
|Six Months Ended
|Research and development||$||5,316||11,427||12,591||21,169|
|General and administrative||4,472||3,571||7,581||7,205|
|Total operating expenses||9,788||14,998||20,172||28,374|
|Loss from operations||(9,788||)||(14,998||)||(20,172||)||(28,374||)|
|Other income (expense):|
|Change in fair value of warrants||5,498||—||199||—|
|Interest expense, net||(241||)||(370||)||(442||)||(728||)|
|Other income (expense)||93||(7||)||87||(8||)|
|Total other income (expense)||5,350||(377||)||(156||)||(736||)|
|Other comprehensive loss:|
|Unrealized gain on available-for-sale securities||—||3||—||—|
|Net loss per share - basic and diluted||$||(0.05||)||$||(0.54||)||$||(0.26||)||$||(1.02||)|
|Weighted-average number of common shares used in computing net loss per share||85,538||28,541||78,428||28,519|
Source: Genocea Biosciences, Inc.