Genocea Provides Corporate Update, Including Second-Quarter 2019 Financial Results
Initiated Part B of Phase 1/2a clinical trial of neoantigen vaccine candidate GEN-009;
Plans to present additional GEN-009 immunogenicity data at
Conference call today at
“Our presentation of GEN-009 immunogenicity data at
Second Quarter 2019 Operational Highlights
- Completed a public equity financing, raising
$42.3 million , including the full exercise of the underwriters’ over-allotment option. - Presented best-in-class immunogenicity results for GEN-009 at the annual meeting of the
American Society of Clinical Oncology (ASCO 2019); the poster presentation was selected by ASCO’sJournal of Clinical Oncology as one of the Top 10 Featured Immuno-oncology Abstracts. - Entered into a research collaboration with Iovance exploring the use of Genocea’s ATLAS neoantigen screening platform in the development of neoantigen-targeted TIL (tumor-infiltrating lymphocyte) products.
- Presented additional ATLAS data at the 2019 Annual Meeting of the
American Association for Cancer Research (AACR 2019). The poster highlighted the potential use of ATLAS as a tool to predict the advanced melanoma patients for whom checkpoint therapy might prove beneficial.
Second Quarter 2019 Financial Results
- Cash position: As of
June 30, 2019 , cash and cash equivalents were$58.7 million versus$26.4 million as ofDecember 31, 2018 . - Research and Development (R&D) expenses: R&D expenses were
$6.8 million for the quarter endedJune 30, 2019 , compared to$5.3 million for the same period in 2018. - General and Administrative (G&A) expenses: G&A expenses were
$3.2 million for the quarter endedJune 30, 2019 , compared to$4.5 million for the same period in 2018. - Net loss: Net loss was
$6.5 million for the quarter endedJune 30, 2019 , compared to a net loss of$4.4 million for the quarter endedJune 30, 2018 .
Guidance
Genocea expects that its existing cash and cash equivalents are sufficient to support its operations into the first quarter of 2021.
Conference Call
Genocea will host a conference call and webcast today at
About
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
Forward-Looking Statements
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
(Tables follow)
CONDENSED CONSOLIDATED BALANCE SHEETS (UNAUDITED)
(In thousands)
| June 30, 2019 | December 31, 2018 | |||||||
| Cash and cash equivalents | $ | 58,670 | $ | 26,361 | ||||
| Other assets | 12,092 | 4,754 | ||||||
| Total assets | $ | 70,762 | $ | 31,115 | ||||
| Debt, current and long-term | $ | 13,732 | $ | 14,822 | ||||
| Accounts payable, accrued expenses and other liabilities | 13,203 | 5,486 | ||||||
| Warrant liability | 5,389 | 3,472 | ||||||
| Total liabilities | 32,324 | 23,780 | ||||||
| Stockholders' equity | 38,438 | 7,335 | ||||||
| Total liabilities and stockholders’ equity | $ | 70,762 | $ | 31,115 | ||||
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS (UNAUDITED)
(In thousands, except per share data)
| Three Months Ended June 30, |
Six Months Ended June 30, |
||||||||||||||
| 2019 | 2018 | 2019 | 2018 | ||||||||||||
| Operating expenses: | |||||||||||||||
| Research and development | $ | 6,849 | $ | 5,316 | $ | 13,309 | $ | 12,591 | |||||||
| General and administrative | 3,217 | 4,472 | 6,234 | 7,581 | |||||||||||
| Total operating expenses | 10,066 | 9,788 | 19,543 | 20,172 | |||||||||||
| Loss from operations | (10,066 | ) | (9,788 | ) | (19,543 | ) | (20,172 | ) | |||||||
| Other income (expense): | |||||||||||||||
| Change in fair value of warrants | 3,870 | 5,498 | (1,917 | ) | 199 | ||||||||||
| Interest expense, net | (299 | ) | (148 | ) | (602 | ) | (355 | ) | |||||||
| Total other income (expense) | 3,571 | 5,350 | (2,519 | ) | (156 | ) | |||||||||
| Net loss | $ | (6,495 | ) | $ | (4,438 | ) | $ | (22,062 | ) | $ | (20,328 | ) | |||
| Net loss per share - basic and diluted | $ | (0.42 | ) | $ | (0.42 | ) | $ | (1.57 | ) | $ | (2.07 | ) | |||
| Weighted-average number of common shares used in computing net loss per share | 15,344 | 10,693 | 14,035 | 9,804 | |||||||||||
Contact:
617-715-6687
jennifer.lavin@genocea.com
Source: Genocea Biosciences, Inc.