Genocea Biosciences Reports Second Quarter 2017 Financial Results
August 09 2017 - 8:00AM
- Recently reported positive top-line 12-month
Phase 2b data for GEN-003 in genital herpes -- IND filing for
neoantigen cancer vaccine, GEN-009, expected in Q4 2017 -
Genocea Biosciences, Inc. (NASDAQ:GNCA), a biopharmaceutical
company developing novel vaccines and immunotherapies targeting T
cell antigens, today reported financial results for the second
quarter of 2017. Genocea is developing GEN-003, an investigational
immunotherapy for the treatment of genital herpes, and is applying
its unique and proprietary T cell antigen identification platform,
ATLAS™, to immuno-oncology and cancer vaccine development.
Highlights of the Second Quarter of 2017 and Recent
Events
- May 2017 – In its first quarter earnings report, Genocea
announced (i) the successful completion of its end-of-Phase 2
meeting for GEN-003 with the U.S. Food & Drug Administration
and (ii) data from its prior GEN-003 Phase 2 trial indicating that
the initial course of injections sustained clinical and virologic
efficacy for at least 24 months.
- June 2017 – Genocea announced its addition to the Russell 3000®
and Russell 2000® Indices as part of the annual reconstitution of
those indexes.
- July 2017 – Genocea reported positive top-line 12-month Phase
2b data for GEN-003 including statistically significant data on the
expected Phase 3 primary endpoint with the Phase 3 dose, and
positive results on multiple secondary clinical endpoints.
Chip Clark, president and chief executive officer of Genocea,
commented: “We are delighted with the recent positive GEN-003
12-month Phase 2b data and continue to explore means of securing
capital for this program to enable the start of Phase 3. We believe
that, if approved, GEN-003 could become the first new therapy to
treat genital herpes in more than 20 years and address serious
unmet patient needs.
"With respect to our cancer vaccine program, recent scientific
publications on neoantigen cancer vaccines suggest that the concept
has promise, but we think that there is significant room for
improvement. We believe that Genocea’s ATLAS platform can enable
better neoantigen selection and that, combined with our vaccinology
expertise, positions us strongly in this emerging field. We expect
to file an IND by the end of 2017 for our neoantigen vaccine,
GEN-009, and we are also continuing our pre-clinical work on common
antigen cancer vaccines and an EBV-related cancer vaccine.”
Financial GuidanceGenocea expects that its
existing cash and cash equivalents are sufficient to support its
operating expenses and capital expenditure requirements into 2018.
Genocea is currently exploring various avenues to secure capital to
advance GEN-003 into Phase 3 trials and does not intend to commence
Phase 3 development of GEN-003 until it has secured such
capital.
Second-Quarter 2017 Financial Results
- Cash Position: Cash and cash equivalents as of
June 30, 2017 were $35.2 million compared to cash, cash equivalents
and investments of $48.7 million as of March 31, 2017.
- Research and Development (R&D)
Expenses: R&D expenses for the quarter ended June
30, 2017 increased $4.7 million, to $11.4 million, from the same
period in 2016. The increase was primarily driven by higher
external manufacturing-related expenses and increases in
compensation, consulting and professional services to support both
the clinical drug supply and clinical planning activities in
support of GEN-003 Phase 3 program readiness. Spending increases on
Genocea’s immuno-oncology and cancer vaccine programs were driven
primarily by increased manufacturing and compensation, consulting
and professional services in anticipation of Genocea’s expected
filing of an Investigational New Drug (IND) application for GEN-009
in 2017. Increased spending on these programs was offset by lower
costs on deprioritized infectious disease programs.
- General and Administrative (G&A)
Expenses: G&A expenses for the second quarter of
2017 were $3.6 million, compared to $4.0 million for the
same period in 2016 reflecting lower depreciation costs and lower
consulting and professional services costs.
- Net Loss: Net loss was $15.4
million for the quarter ended June 30, 2017, compared to a net
loss of $11.0 million for the same period in 2016.
No Second Quarter 2017 Financial Results Conference
CallAs announced during the GEN-003 Phase 2b 12-month
results conference call on July 24, 2017, Genocea will not be
holding a conference call relating to these results.
About Genocea Biosciences, Inc.Genocea is
harnessing the power of T cell immunity to develop life-changing
vaccines and immunotherapies. While traditional immunotherapy
discovery methods have largely used predictive methods to propose T
cell targets, or antigens, Genocea has successfully developed
ATLAS™, its proprietary technology platform, to identify clinically
relevant antigens of T cells based on actual human immune
responses. Genocea used ATLAS to identify the antigens in its lead
clinical candidate, GEN-003, an investigational immunotherapy to
treat genital herpes, and is currently using ATLAS in
immuno-oncology applications to develop neoantigen cancer vaccines
(with an IND filing expected by the end of 2017), general cancer
vaccines and a vaccine targeting cancers caused by Epstein-Barr
Virus. For more information, please visit 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 that 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; anticipated timing for initiation of new clinical
trials; 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 to continue its clinical programs
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, 2016 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) |
|
|
June 30, |
|
December 31, |
|
2017 |
|
2016 |
Cash, cash equivalents
and investments |
$ |
35,225 |
|
$ |
63,362 |
Other assets |
|
7,387 |
|
|
6,534 |
Total assets |
$ |
42,612 |
|
$ |
69,896 |
|
|
|
|
|
|
Debt, current and
long-term |
$ |
17,214 |
|
$ |
16,958 |
Accounts payable |
|
2,463 |
|
|
3,043 |
Accrued expenses and
other liabilities |
|
3,728 |
|
|
4,354 |
Total liabilities |
|
23,405 |
|
|
24,355 |
Stockholders'
equity |
|
19,207 |
|
|
45,541 |
Total liabilities and
stockholders’ equity |
$ |
42,612 |
|
$ |
69,896 |
|
|
|
|
|
|
|
GENOCEA BIOSCIENCES, INC. |
CONDENSED CONSOLIDATED STATEMENTS OF
OPERATIONS (UNAUDITED) |
(In thousands, except per share
amounts) |
|
|
Three Months Ended June 30, |
|
Six Months Ended June 30, |
|
2017 |
|
2016 |
|
2017 |
|
2016 |
Grant revenue |
$ |
— |
|
|
$ |
— |
|
|
$ |
— |
|
|
$ |
235 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Operating
expenses: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Research
and development |
|
11,427 |
|
|
|
6,678 |
|
|
|
21,169 |
|
|
|
14,010 |
|
General
and administrative |
|
3,571 |
|
|
|
4,026 |
|
|
|
7,205 |
|
|
|
7,950 |
|
Refund of
research and development expense |
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
(1,592 |
) |
Total operating
expenses |
|
14,998 |
|
|
|
10,704 |
|
|
|
28,374 |
|
|
|
20,368 |
|
Loss from
operations |
|
(14,998 |
) |
|
|
(10,704 |
) |
|
|
(28,374 |
) |
|
|
(20,133 |
) |
Other income and
expense: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Interest
income |
|
71 |
|
|
|
111 |
|
|
|
148 |
|
|
|
220 |
|
Interest
expense |
|
(448 |
) |
|
|
(430 |
) |
|
|
(884 |
) |
|
|
(861 |
) |
Total other income and
expense |
|
(377 |
) |
|
|
(319 |
) |
|
|
(736 |
) |
|
|
(641 |
) |
Net
loss |
$ |
(15,375 |
) |
|
$ |
(11,023 |
) |
|
$ |
(29,110 |
) |
|
$ |
(20,774 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss per share -
basic and diluted |
$ |
(0.54 |
) |
|
$ |
(0.39 |
) |
|
$ |
(1.02 |
) |
|
$ |
(0.74 |
) |
Weighted-average number
of common shares used in computing net loss per share |
|
28,541 |
|
|
|
28,276 |
|
|
|
28,519 |
|
|
|
28,214 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
For media:
Jennifer LaVin
207-360-0473
jennifer.lavin@genocea.com
For investors:
Jonathan Poole
617-876-8191
jonathan.poole@genocea.com
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