Genocea Reports Third Quarter 2018 Financial and Operating Results
November 01 2018 - 08:00AM
Neoantigen vaccine program GEN-009 Phase 1/2a
clinical trial enrolling patientsPresenting novel findings at
upcoming SITC conference
Genocea Biosciences, Inc. (NASDAQ: GNCA), a biopharmaceutical
company developing neoantigen cancer immunotherapies, today
reported its financial and operating results for the third quarter
ended September 30, 2018.
“In the year since our strategic pivot, we have made significant
progress by advancing our lead cancer vaccine candidate, GEN-009,
into the clinic and using our ATLAS™ platform to identify and
characterize the T cell responses cancer patients make to both
tumor-associated antigens and neoantigens,” said Chip Clark,
president & CEO of Genocea. “We continue to believe that ATLAS,
which lets patients’ own T cells identify the optimal antigens for
their cancer immunotherapies, stands apart from peer approaches
that instead rely on software to predict antigens. We believe that
the next evidence for this will emerge from our upcoming
presentations at SITC and then from the first patient cohort in our
Phase 1/2a clinical trial for GEN-009, from which we expect to
report immunogenicity data in the first half of 2019.”
- Recent Milestones & EventsOctober 2018:
Announced multiple presentations at the upcoming meeting of the
Society for Immunotherapy of Cancer (SITC 2018) taking place
November 7-11, 2018 at the Walter E. Washington Convention Center
in Washington, D.C. These posters further highlight the advantages
of Genocea’s ATLAS platform over in silico methods in identifying
both neoantigens for vaccine inclusion and “inhibitory” neoantigens
for exclusion. Genocea believes that the "inhibitory" antigen
findings may point to novel biological insights only available
through ATLAS. The following posters will be presented
simultaneously on Saturday, November 10 from 12:20 - 1:50 p.m. and
7:00 - 8:30 p.m. ET in Poster Hall E:- Poster Number:
P154Title: Empiric profiling of
neoantigen-specific T cell responses in NSCLC patients with ATLAS™
reveals unexpected neoantigen and inhibitory antigen
profiles- Poster Number:
P166Title: Ex vivo ATLAS-identified
inhibitory neoantigens promote mouse melanoma tumor
progression- Poster Number:
P174Title: A phase 1/2a study to evaluate
the safety, tolerability, immunogenicity, and anti-tumor activity
of GEN-009 adjuvanted neoantigen vaccine in adult patients with
selected solid tumors
- October 2018: Strengthened its leadership team with the
addition of Thomas Davis, M.D. as Chief Medical Officer and Derek
Meisner, J.D., as General Counsel. Dr. Davis joins Genocea with 20+
years of academic and industry experience in immuno-oncology and
cancer drug development. Mr. Meisner brings broad legal expertise
to Genocea as the company’s first General Counsel.
Third Quarter 2018 Financial Results
- Cash Position: As of September 30, 2018, cash and cash
equivalents were $34.5 million compared to $12.3 million, as of
December 31, 2017.
- Research and Development (R&D) Expenses: R&D expenses
were $6.4 million for the quarter ended September 30, 2018,
compared to $10.2 million for the same period in 2017. The decrease
was due largely to reduced headcount-related costs, external
development, clinical, and consulting costs.
- General and Administrative (G&A) Expenses: G&A expenses
were $4.1 million for the quarter ended September 30, 2018,
compared to $3.8 million for the same period in 2017. The increase
was primarily due to increases in professional services expenses,
partially offset by decreases in consulting costs.
- Net Loss: Net loss was $7.8 million for the quarter ended
September 30, 2018, compared to a net loss of $16.9 million for
quarter ended September 30, 2017.
Financial GuidanceGenocea expects that its
existing cash and cash equivalents are sufficient to support its
operating expenses and capital expenditure requirements into the
fourth quarter of 2019.
Genocea continues to explore strategic alternatives for GEN-003,
its Phase 3-ready investigational immunotherapy for the treatment
of genital herpes.
Conference CallGenocea will host a conference
call and webcast today at 9:00 a.m. ET. The conference call may be
accessed by dialing (844) 826-0619 (domestic) or (315) 625-6883
(international) and referring to conference ID number 9864055. A
live webcast of the conference call will be available online from
the investor relations section of the Company's website at
http://ir.genocea.com. A webcast replay of the conference call will
be available on the Genocea website beginning approximately two
hours after the event and will be archived for 90 days.
About Genocea Biosciences, Inc.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 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.
Forward-Looking StatementsThis
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 December 31, 2017 and any
subsequent SEC filings. These forward-looking statements speak only
as of the date of this press release and Genocea assumes no duty to
update forward-looking statements, except as may be required by
law.
|
GENOCEA BIOSCIENCES,
INC.CONDENSED CONSOLIDATED BALANCE
SHEETS(UNAUDITED)(In
thousands) |
|
|
September 30,
2018 |
|
December 31,
2017 |
Cash and cash equivalents |
$ |
34,494 |
|
|
$ |
12,273 |
|
Other assets |
5,207 |
|
|
5,215 |
|
Total assets |
$ |
39,701 |
|
|
$ |
17,488 |
|
|
|
|
|
Debt, current and long-term |
$ |
14,638 |
|
|
$ |
14,311 |
|
Accounts payable |
1,276 |
|
|
3,516 |
|
Accrued expenses and other liabilities |
4,268 |
|
|
5,711 |
|
Warrant liability |
13,021 |
|
|
— |
|
Total liabilities |
33,203 |
|
|
23,538 |
|
Stockholders' equity (deficit) |
6,498 |
|
|
(6,050 |
) |
Total liabilities and stockholders’ equity
(deficit) |
$ |
39,701 |
|
|
$ |
17,488 |
|
|
GENOCEA BIOSCIENCES,
INC.CONDENSED CONSOLIDATED STATEMENTS OF
OPERATIONS AND COMPREHENSIVE
LOSS(UNAUDITED)(In thousands,
except per share data) |
|
|
Three Months Ended September
30, |
|
Nine Months Ended September
30, |
|
2018 |
|
2017 |
|
2018 |
|
2017 |
Operating expenses: |
|
|
|
|
|
|
|
Research and development |
$ |
6,359 |
|
|
$ |
10,155 |
|
|
$ |
18,950 |
|
|
$ |
31,324 |
|
General and administrative |
4,101 |
|
|
3,750 |
|
|
11,682 |
|
|
10,955 |
|
Restructuring costs |
— |
|
|
2,591 |
|
|
— |
|
|
2,591 |
|
Total operating expenses |
10,460 |
|
|
16,496 |
|
|
30,632 |
|
|
44,870 |
|
Loss from operations |
(10,460 |
) |
|
(16,496 |
) |
|
(30,632 |
) |
|
(44,870 |
) |
Other income (expense): |
|
|
|
|
|
|
|
Change in fair value of warrants |
2,894 |
|
|
— |
|
|
3,093 |
|
|
— |
|
Interest expense, net |
(266 |
) |
|
(366 |
) |
|
(708 |
) |
|
(1,094 |
) |
Other income (expense) |
(1 |
) |
|
(6 |
) |
|
86 |
|
|
(14 |
) |
Total other income (expense) |
2,627 |
|
|
(372 |
) |
|
2,471 |
|
|
(1,108 |
) |
Net loss |
$ |
(7,833 |
) |
|
$ |
(16,868 |
) |
|
$ |
(28,161 |
) |
|
$ |
(45,978 |
) |
|
|
|
|
|
|
|
|
Other comprehensive loss: |
|
|
|
|
|
|
|
Comprehensive loss |
$ |
(7,833 |
) |
|
$ |
(16,868 |
) |
|
$ |
(28,161 |
) |
|
$ |
(45,978 |
) |
Net loss per share - basic and diluted |
$ |
(0.09 |
) |
|
$ |
(0.59 |
) |
|
$ |
(0.35 |
) |
|
$ |
(1.61 |
) |
Weighted-average number of common shares used in computing net loss
per share |
86,626 |
|
|
28,666 |
|
|
81,191 |
|
|
28,568 |
|
|
|
|
|
|
|
|
|
|
|
|
|
Contact:Jennifer
LaVin617-715-6687jennifer.lavin@genocea.com
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