LEXINGTON, Mass., Nov. 7, 2017 /PRNewswire/ -- Agenus Inc. (NASDAQ:
AGEN), an immuno-oncology (I-O) company with a pipeline of immune
checkpoint antibodies and cancer vaccines, provided a corporate
update and reported financial results for the third quarter ended
September 30, 2017.
"We are pleased with the substantial progress Agenus has made in
the third quarter. We have initiated a combination trial with our
anti-CTLA-4 antibody. Additionally, we are accruing patients
with our CTLA-4 and PD-1 programs for trials designed for BLA
filing," said Garo H. Armen, Ph.D.,
Chairman and CEO of Agenus "We are committed to continuing to
innovate having generated several first-in-class and best-in-class
immuno-oncology agents; Our partnering discussions are maturing on
multiple fronts and we expect to close on several business
development transactions across our portfolio between now and the
end of the first quarter of 2018."
Anticipated Milestones for 4Q 2017
- AGEN1884 (anti-CTLA-4) Phase 1 trial to complete
dose-escalation and generate safety and pharmacodynamic data
- AGEN2034 (anti-PD-1) Phase 1/2 trial
-
- Complete dose-escalation and define optimal combination
dose
- Expand trial to include patients with second line cervical
cancer
- AutoSynVax™ (neoantigen vaccine): immunological readouts
expected in patients with advanced malignancies
- Presentations on AGEN1884 and AGEN2034 planned for
Society for Immunotherapy of Cancer (SITC)
- Planning for combination trials of AGEN1884 and
AGEN2034
- Advance business development discussions and partnering
transactions
- Advancing our cell therapy business entity, AgenTus, with
partnership discussions and grant funding
Tracking to deliver with recent highlights:
- Data on AGEN1884 presented at ASCO
-
- AGEN1884 safe at doses up to 3mg/kg
- Preliminary data reveal signals of clinical activity with
complete response in patient with angiosarcoma with reduction in
tumor burden at 0.1 mg/kg dose (update planned for poster
presentation at SITC2017)
- Initiating a combination trial with AGEN1884 and a commercially
available agent to accelerate development planning
- Upcoming presentations on AGEN1884 and AGEN2034 are
planned for SITC:
-
- AGEN2034 cooperates with AGEN1884 to enhance T cell
responsiveness
- Preclinical data reveal AGEN2034 + AGEN1884 promote a
pharmacodynamic response in vivo
- AutoSynVax™ data presented at AACR2017 and CIMT2017
demonstrating immunogenicity and synergy in combination with CTLA-4
and OX-40 with early signals of clinical
immunogenicity
- Manufacturing update:
-
- Agenus West manufacturing successfully supplied GMP material
for clinical programs; preparing for GMP material for our
registrational program in 1H2018
- QS-21 Stimulon® update:
-
- GSK's shingles vaccine, Shingrix, containing Agenus' QS-21
Stimulon® adjuvant, was approved by the US FDA on
October 20, 2017, launch is
anticipated in Q4
- GSK's Shingrix was approved by Health Canada October 2017
- US Centers for Disease Control and Prevention's (CDC) Advisory
Committee on Immunization Practices (ACIP) voted in favor of three
recommendations for the use of Shingrix (Zoster Vaccine
Recombinant, Adjuvanted) containing QS-21 Stimulon for the
prevention of shingles (herpes zoster) and related complications
for immunocompetent adults age 50 year and older, for prevention of
shingles and related complication for immunocompetent adults
who previously received Zoster Vaccine Live (Zostavax),
and Shingrix is preferred over Zoster Vaccine Live (Zostavax)
for the prevention of herpes zoster and related complications.
- AgenTus Cell Therapy Business
-
- On October 23, 2017, Agenus
announced the establishment of cell therapy business entity and the
appointment of Bruno Lucidi as CEO
of AgenTus Therapeutics, Inc., a subsidiary of Agenus established
to focus on the discovery, development, and commercialization of
Adoptive Cell Therapy (ACT)
Third Quarter 2017 Financial Results
Cash, cash equivalents and short-term investments were
$70.1 million at September 30, 2017 compared to $76.4 million as of December 31, 2016. On November 2, 2017, we exercised our option to
issue additional notes under our existing note agreement which will
add $15 million of cash proceeds.
Cash used in operating activities for the three months ended
September 30, 2017 was $26.2 million compared to $23.8 million for the same period in 2016.
For the third quarter ended September 30,
2017, Agenus reported a net loss of $36.8 million, or $0.37 per share, compared with a net loss for the
third quarter of 2016 of $40.8
million, or $0.47 per share.
The decrease in net loss for the three months ended September 30, 2017, compared to the net loss for
the same period in 2016, was due to the decrease in the value or
our contingent considerations offset by an increase in our research
and development expenses.
For the nine months ended September 30,
2017, Agenus reported a net loss of $85.7 million, or $0.88 per share, compared with a net loss for the
same period in 2016 of $100.9 million
or $1.16 per share. The
decrease in net loss for the nine months ended September 30, 2017, compared to the net loss for
the same period in 2016, was primarily due to the accelerated
milestone payment received from Incyte during the first quarter of
2017. Our operating expenses increased $3.5 million over the same period in 2016.
Cash used in operating activities for the nine months ended
September 30, 2017 was $68.4 million compared to $63.8 million for the same period in 2016.
Conference Call, Webcast and Prepared Statement
Information
Agenus executives will host a conference call on Tuesday, November 7, 2017 at 11:00 a.m. Eastern Time. To access the live call,
dial 1-844-492-3727 (U.S.) or 1-412-317-5118 (international) and
ask to be joined into the Agenus call. The call will also be
webcast and will be accessible from the Company's website at
http://investor.agenusbio.com/presentation-webcasts or via the
following link: https://www.webcaster4.com/Webcast/Page/1556/23075.
A replay will be available on the Company's website approximately
two hours after the call and will remain available for 90 days.
About Agenus
Agenus is a clinical-stage immuno-oncology company focused on
the discovery and development of therapies that engage the body's
immune system to fight cancer. The Company's vision is to expand
the patient populations benefiting from cancer immunotherapy by
pursuing a number of combination approaches that leverage a broad
repertoire of antibody therapeutics and proprietary cancer vaccine
platforms. The Company is equipped with a suite of antibody
discovery platforms and a state-of-the-art GMP manufacturing
facility with the capacity to support early phase clinical
programs. Agenus is headquartered in Lexington, MA. For
more information, please visit www.agenusbio.com; information that
may be important to investors will be routinely posted on our
website.
Forward-Looking Statements
This press release contains forward-looking statements that are
made pursuant to the safe harbor provisions of the federal
securities laws, including statements regarding Agenus' clinical
trial plans and activities, and anticipated milestones, including
the expected closing of several business development transaction,
and upcoming corporation presentations. These forward-looking
statements are subject to risks and uncertainties that could cause
actual results to differ materially. These risks and uncertainties
include, among others, the factors described under the Risk Factors
section of our most recent Quarterly Report on Form 10-Q or Annual
Report on Form 10-K filed with the Securities and Exchange
Commission. Agenus cautions investors not to place considerable
reliance on the forward-looking statements contained in this
release. These statements speak only as of the date of this press
release, and Agenus undertakes no obligation to update or revise
the statements, other than to the extent required by law. All
forward-looking statements are expressly qualified in their
entirety by this cautionary statement.
Contact:
Agenus Inc.
Jennifer Buell, PhD
781-674-4420
Jennifer.Buell@agenusbio.com
Summary
Consolidated Financial Information
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Condensed
Consolidated Statements of Operations Data
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(in thousands, except
per share data)
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(unaudited)
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Three months ended
September 30,
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Nine months ended
September 30,
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2017
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2016
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2017
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2016
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Revenue
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$
3,360
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$
4,446
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$
34,523
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$
16,997
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Operating
expenses:
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Research and
development
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25,789
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21,588
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84,253
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68,988
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General and
administrative
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8,051
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8,107
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23,957
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24,456
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Non-cash contingent
consideration fair value adjustment
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1,184
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10,975
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123
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11,354
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Operating
loss
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(31,664)
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(36,224)
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(73,810)
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(87,801)
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Other expense,
net
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(5,178)
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(4,550)
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(11,848)
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(13,071)
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Net loss
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(36,842)
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(40,774)
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(85,658)
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(100,872)
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Dividends on Series
A-1 convertible preferred stock
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(51)
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(51)
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(154)
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(153)
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Net loss attributable
to common stockholders
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$
(36,893)
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$
(40,825)
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$
(85,812)
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$
(101,025)
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Per common share
data, basic and diluted:
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Net loss attributable
to common stockholders
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$
(0.37)
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$
(0.47)
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$
(0.88)
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$
(1.16)
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Weighted average
number of common shares outstanding, basic and diluted
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99,892
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87,207
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97,557
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86,954
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Condensed
Consolidated Balance Sheet Data
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(in
thousands)
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(unaudited)
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September 30,
2017
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December 31,
2016
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Cash, cash
equivalents and short-term investments
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$
70,051
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$
76,437
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Total
assets
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149,270
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156,986
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Total stockholders'
deficit
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(51,594)
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(39,126)
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SOURCE Agenus