Genocea Reports Fourth Quarter and Year-End 2016 Financial Results
February 16 2017 - 7:30AM
- Positive Phase 2b clinical data confirm
attractive profile for GEN-003; expected to start Phase 3 program
in 4Q 2017 -
Genocea Biosciences, Inc. (NASDAQ:GNCA), a biopharmaceutical
company developing T cell-directed vaccines and immunotherapies,
today reported corporate highlights and financial results for the
fourth quarter and year ended December 31, 2016. Genocea is
developing GEN-003, a therapeutic vaccine candidate for the
treatment of genital herpes expected to enter Phase 3 development
in 2017, and is applying its unique and proprietary T cell antigen
identification platform, ATLAS™, to immuno-oncology and cancer
vaccine development.
“We are proud to report on our 2016 achievements, as we made
important advances in both our GEN-003 and immuno-oncology
programs,” said Chip Clark, president and chief executive officer
of Genocea. “With the announcements of positive virologic and
clinical data for GEN-003 from our ongoing Phase 2b trial, we
believe we have confirmed a highly attractive clinical profile for
GEN-003, which has the potential to be the first new treatment for
patients with genital herpes in more than 20 years. We are
encouraged by market research indicating that the GEN-003 clinical
profile is attractive to both physicians and payers, and, most
importantly, to patients, many of whom are dissatisfied with their
current treatment options.”
Mr. Clark continued: “In addition to the progress on GEN-003, we
announced last fall that we are now focusing our early stage
development resources on our immuno-oncology programs. We believe
there is a significant opportunity to use our ATLAS platform in
immuno-oncology to comprehensively profile T cell responses to
cancer. We believe that we can create value by developing novel
therapeutic neoantigen cancer vaccines and by developing
non-invasive assays to define patient selection for clinical trials
and clinical practice. As we presented at our first-ever R&D
Day in December, we are making significant progress in both areas
and remain on track to file an IND for our first cancer vaccine
(GEN-009) by the end of this year.”
Program Highlights
GEN-003 Program Milestones
- March 2016: Announced positive efficacy data from the Phase 2
dose-optimization trial, demonstrating sustained reductions in the
rate of viral shedding and clinical efficacy across secondary
clinical endpoints 12 months after dosing
- June 2016: Presented detailed 6- and 12-month clinical and
viral shedding data from the Phase 2 dose-optimization trial at the
American Society for Microbiology annual general meeting, ASM
Microbe 2016
- September 2016: Announced the first data from the
placebo-controlled Phase 2b trial evaluating a new Phase 3-ready
formulation, with GEN-003 demonstrating significant reduction in
viral shedding immediately after dosing
- October 2016: Presented 12-month immunogenicity data from the
Phase 2 dose-optimization trial at the Infectious Disease Society
of America (IDSA) annual meeting, IDWeek 2016, demonstrating
GEN-003 effects clear and robust T and B cell responses
- January 2017: Announced positive 6-month results from the Phase
2b clinical trial showing statistical significance vs. placebo for
multiple clinical endpoints
Immuno-Oncology Program Milestones
- November 2016: Announced new findings supporting the potential
of the proprietary ATLAS technology to identify clinically
meaningful neoantigens compared to those identified by predictive
algorithms and presented the results at the Society for
Immunotherapy of Cancer’s 31st Annual Meeting & Associated
Programs, SITC 2016
- December 2016: Announced two immuno-oncology collaborations,
Checkmate Pharmaceuticals, Inc. and US Oncology, each employing
ATLAS to characterize T cell responses to optimize clinical
development and to discover new antigens, respectively
Anticipated Upcoming Milestones and Events
Milestones
- 1Q 2017: GEN-003 end-of-Phase 2 meeting with the U.S. Food and
Drug Administration (FDA) expected; will confirm the design of the
GEN-003 Phase 3 program
- 2H 2017: GEN-003 24-month Phase 2 data expected; will inform
likely timing of maintenance dosing for GEN-003
- 2H 2017: GEN-003 12-month Phase 2b data anticipated; expected
to reconfirm clinical profile of GEN-003 at 1 year post dosing
- 4Q 2017: GEN-003 Phase 3 program start expected
- 4Q 2017: GEN-009 neoantigen cancer vaccine Investigational New
Drug (IND) application filing expected
Events
- March 2017: Presentation at the Cowen 37th Annual Health Care
Conference in Boston
- April 2017: Presentation at the Needham & Company 16th
Annual Healthcare Conference in NYC
Financial Guidance
Genocea expects that its existing cash, cash equivalents and
investments are sufficient to support its operating expenses and
capital expenditure requirements into the first quarter of 2018,
without assuming any receipt of proceeds from potential business
development partnerships, equity financings or debt drawdowns. This
guidance assumes commencing Phase 3 trials for GEN-003 for genital
herpes in the fourth quarter of 2017 and filing an IND for GEN-009
for cancer by the end of the year, however it is Genocea’s strategy
to secure additional sources of financing in advance of starting
GEN-003 Phase 3 clinical trials.
Fourth Quarter and Year-End 2016 Financial
Results
- Cash Position: Cash, cash equivalents and
investments as of December 31, 2016 were $63.4 million compared to
$75.5 million as of September 30, 2016.
- Research and Development (R&D)
Expenses: R&D expenses for the quarter ended
December 31, 2016 increased $5.3 million, to $11.8 million, from
the same period in 2015, driven by higher manufacturing and
clinical costs for GEN-003 together with higher personnel and
lab-related costs related to Genocea’s immuno-oncology programs.
These increases were partially offset by reduced spending on early
stage infectious disease programs.
- General and Administrative (G&A)
Expenses: G&A expenses for the fourth quarter of
2016 were $3.9 million, compared to $3.8 million for the
same period in 2015. The slight increase reflects higher personnel
costs to support Genocea’s expanding R&D operations.
- Net Loss: Net loss was $16.0
million for the quarter ended December 31, 2016, compared to a
net loss of $10.3 million for the same period in
2015.
Full Year 2016 Financial Results
- Cash Position: Cash, cash equivalents and
investments as of December 31, 2016 were $63.4
million, compared to $106.4 million as
of December 31, 2015.
- R&D Expenses: R&D expenses for
the year ended December 31, 2016 were $34.6 million, compared
to $28.0 million for the same period in 2015, reflecting higher
personnel costs, consulting and professional services costs,
clinical costs, and lab-related costs to support the continued
advancement of GEN-003. These increased costs were partially offset
by lower GEN-003 manufacturing costs in 2016 compared to 2015.
Increases in personnel and lab related costs across early stage
research programs were offset by a reduction in GEN-004 costs for
which a clinical trial was completed in late 2015 and further
development of this program was suspended.
- G&A Expenses: G&A expenses
were $15.4 million for the year ended December 31,
2016, compared to $14.0 million for the same period in 2015,
reflecting an increase in market research costs to support GEN-003
and higher depreciation costs from facility expansion in late
2015.
- Refund of Research and Development
Expense: A gain of $1.6 million for the quarter ended
March 31, 2016 resulted from cash received pursuant to contractual
obligations under a collaboration agreement with Isconova AB
(“Isconova”) (since acquired by Novavax, Inc.) to refund R&D
expenses paid by Genocea to Isconova between 2009 and 2011 relating
to the development of the Matrix-M adjuvant technology.
- Net Loss: Net loss was $49.6
million for the year ended December 31, 2016, compared to
a net loss of $42.5 million for the same period in 2015.
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 for domestic participants and
(315) 625-6883 for international callers and referencing the
conference ID number 58691835. 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 30 days.
About Genocea Biosciences, Inc.Genocea is
harnessing the power of T cell immunity to develop life-changing
vaccines and immunotherapies. T cells are increasingly recognized
as a critical element of protective immune responses to a wide
range of diseases, but traditional discovery methods have proven
unable to identify the targets of such protective immunity. Using
ATLAS™, its proprietary technology platform, Genocea identifies
these targets to potentially enable the rapid development of
medicines to address critical patient needs. Genocea's pipeline
includes GEN-003, a novel T cell-enabled immunotherapy for genital
herpes currently in Phase 2 clinical development, and earlier-stage
investments in immuno-oncology. For more information, please visit
the company's website at www.genocea.com.
Forward-Looking StatementsStatements herein
relating to future business performance, conditions or strategies
and other financial and business matters, including expectations
regarding clinical developments, are forward-looking statements
within the meaning of the Private Securities Litigation Reform Act.
Genocea cautions that these forward-looking statements are subject
to numerous assumptions, risks and uncertainties, which change over
time. Factors that may cause actual results to differ materially
from the results discussed in the forward-looking statements or
historical experience include risks and uncertainties, including
Genocea's ability to progress any product candidates in preclinical
or clinical trials; the ability of ATLAS to identify promising
oncology vaccine and immunotherapy product candidates; the scope,
rate and progress of its preclinical studies and clinical trials
and other research and development activities; anticipated clinical
trial results; current results may not be predictive of future
results; even if the data from preclinical studies or clinical
trials is positive, regulatory authorities may require additional
studies for approval and the product may not prove to be safe and
efficacious; Genocea's ability to enter into future collaborations
with industry partners and the government and the terms, timing and
success of any such collaboration; risks associated with the
manufacture and supply of clinical and commercial product; the cost
of filing, prosecuting, defending and enforcing any patent claims
and other intellectual property rights; Genocea's ability to obtain
rights to technology; competition for clinical resources and
patient enrollment from drug candidates in development by other
companies with greater resources and visibility; the rate of cash
utilized by Genocea in its business and the period for which
existing cash will be able to fund such operation; Genocea's
ability to obtain adequate financing in the future through product
licensing, co-promotional arrangements, public or private equity or
debt financing or otherwise; general business conditions;
competition; business abilities and judgment of personnel; the
availability of qualified personnel and other factors set forth
under "Risk Factors" in Genocea's Annual Report on Form 10-K for
the fiscal year ended December 31, 2015 and other filings with the
Securities and Exchange Commission (the "SEC"). Further information
on the factors and risks that could affect Genocea's business,
financial conditions and results of operations is contained in
Genocea's filings with the SEC, which are available at
www.sec.gov. These forward-looking statements speak only as of
the date of this press release and Genocea assumes no duty to
update forward-looking statements.
|
GENOCEA BIOSCIENCES, INC. |
CONDENSED CONSOLIDATED BALANCE SHEETS
(UNAUDITED) |
(In thousands) |
|
|
December 31, |
|
December 31, |
|
2016 |
|
2015 |
|
|
|
|
Cash, cash equivalents
and investments |
$ |
63,362 |
|
|
$ |
106,432 |
|
Other assets |
6,534 |
|
|
5,710 |
|
Total assets |
$ |
69,896 |
|
|
$ |
112,142 |
|
|
|
|
|
Debt, current and
long-term |
$ |
16,958 |
|
|
$ |
16,477 |
|
Accounts payable |
3,043 |
|
|
1,757 |
|
Accrued expenses and
other liabilities |
4,354 |
|
|
4,012 |
|
Deferred revenue |
— |
|
|
235 |
|
Total liabilities |
24,355 |
|
|
22,481 |
|
Stockholders'
equity |
45,541 |
|
|
89,661 |
|
Total liabilities and
stockholders’ equity |
$ |
69,896 |
|
|
$ |
112,142 |
|
|
GENOCEA BIOSCIENCES, INC. |
CONDENSED CONSOLIDATED STATEMENTS OF
OPERATIONS (UNAUDITED) |
(In thousands, except per share
amounts) |
|
|
Three months ended December 31, |
|
Twelve months ended December 31, |
|
2016 |
|
2015 |
|
2016 |
|
2015 |
Grant revenue |
$ |
— |
|
|
$ |
221 |
|
|
$ |
235 |
|
|
$ |
670 |
|
|
|
|
|
|
|
|
|
Operating
expenses: |
|
|
|
|
|
|
|
Research and
development |
11,824 |
|
|
6,513 |
|
|
34,645 |
|
|
28,049 |
|
General and
administrative |
3,858 |
|
|
3,781 |
|
|
15,427 |
|
|
13,987 |
|
Refund of
research and development expense |
— |
|
|
— |
|
|
(1,592 |
) |
|
— |
|
Total operating
expenses |
15,682 |
|
|
10,294 |
|
|
48,480 |
|
|
42,036 |
|
Loss from
operations |
(15,682 |
) |
|
(10,073 |
) |
|
(48,245 |
) |
|
(41,366 |
) |
Other income and
expense: |
|
|
|
|
|
|
|
Interest
income |
87 |
|
|
93 |
|
|
410 |
|
|
163 |
|
Interest
expense |
(439 |
) |
|
(334 |
) |
|
(1,738 |
) |
|
(1,280 |
) |
Total other income and
expense |
(352 |
) |
|
(241 |
) |
|
(1,328 |
) |
|
(1,117 |
) |
Net
loss |
$ |
(16,034 |
) |
|
$ |
(10,314 |
) |
|
$ |
(49,573 |
) |
|
$ |
(42,483 |
) |
|
|
|
|
|
|
|
|
Net loss per share -
basic and diluted |
$ |
(0.56 |
) |
|
$ |
(0.37 |
) |
|
$ |
(1.75 |
) |
|
$ |
(1.74 |
) |
Weighted-average number
of common shares used in computing net loss per share |
28,394 |
|
|
28,118 |
|
|
28,299 |
|
|
24,460 |
|
For media:
Jennifer LaVin
O: 617-715-6687
jennifer.lavin@genocea.com
For investors:
Jonathan Poole
O: 617-876-8191
jonathan.poole@genocea.com
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