LEXINGTON, Mass., Oct. 27, 2016 /PRNewswire/ -- Agenus Inc.
(NASDAQ: AGEN), an immuno-oncology (I-O) company developing
antibodies, including checkpoint inhibitors and other checkpoint
modulators and cancer vaccines, today provided an update on its
progress and reported financial results for the third quarter ended
September 30, 2016.
"In the third quarter we advanced our pre-clinical and clinical
programs and focused our efforts on our product development plans
with an intent to commercialize Agenus' first generation of I-O
products in the next five years," commented Garo H. Armen, Ph.D., Chairman and CEO of
Agenus. "We have delineated our clinical development path as it
relates to our monoclonal antibodies, targeting the foundational
immune checkpoints CTLA-4 and PD-1. In addition, we are steering
our antibody vaccine combinations towards the clinic. Our world
class team, along with our diverse portfolio and capabilities, are
key differentiators for Agenus to compete in the field and to
deliver on the promise of immunotherapy."
Recent Highlights
- Our first CTLA-4 antibody AGEN1884 advanced in the clinic.
- Our novel checkpoint antibodies and vaccine programs progressed
in various stages of development.
- GlaxoSmithKline's Shingrix® vaccine candidate
containing Agenus' QS-21 Stimulon® for prevention of
shingles in adults aged 50 years or older, was filed for US
regulatory approval.
- Jean-Marie Cuillerot, M.D. appointed Vice President and Global
Head of Clinical Development.
- James Gorman, M.D., Ph.D.
appointed Vice President of Strategic Planning and Portfolio
Management.
Projected Near-Term Milestones
- Phase 1 trial initiation for OX40 agonist INCAGN1949 in
collaboration with Incyte.
- Phase 1 trial initiation for PD-1 antagonist AGEN2034.
- Clinical study initiation combining CTLA-4 and PD-1
antagonists.
- Third party-sponsored randomized trial initiation for Prophage™
together with a checkpoint antagonist in newly diagnosed
glioblastoma.
- Phase 1 trial initiation for AutoSynVax™.
- Consummation of additional strategic partnerships.
Third Quarter 2016 Financial Results
For the third quarter ended September 30,
2016, Agenus reported a net loss attributable to common
stockholders of $40.8 million which
includes $18.7 million of non-cash
expenses. This compares to a net loss attributable to common
stockholders for the third quarter of 2015 of $13.2 million which included $4.1 million of non-cash income. Net loss was
$0.47 per share, and $0.16 per share, basic and diluted, for the three
months ended September 30, 2016 and
2015, respectively. The increase in net loss attributable to
common stockholders for the three months ended September 30, 2016, compared to the net loss
attributable to common stockholders for the same period in 2015,
was largely due to the $22.7 million
increase in non-cash expenses primarily from fair value adjustments
of the contingent obligations in addition to $4.9 million applicable to the advancement of the
checkpoint and cancer vaccine programs.
For the nine months ended September 30,
2016, the company reported a net loss attributable to common
stockholders of $101.0 million, which
includes $35.9 million in non-cash
expenses, compared with a net loss attributable to common
stockholders of $72.4 million, which
included $22.5 million in non-cash
expenses, for the nine months ended September 30, 2015. Net loss was
$1.16 per share and $0.95 per share, basic and diluted for the nine
months ended September 30, 2016 and
2015, respectively.
Cash, cash equivalents and short-term investments were
$95.4 million as of September 30, 2016.
Conference Call, Webcast and Prepared Statement
Information
Agenus executives will host a conference call on Thursday, Oct. 27, 2016 at 11 a.m. Eastern Time. To access the live call,
dial 1-877-870-4263 (U.S.) or 1-412-317-0790 (International) and
ask to be joined into the "Agenus Third Quarter 2016 Earnings
Call." The call will also be webcast and will be accessible from
the Company's website at www.agenusbio.com/webcast. A replay of the
webcast will be available on the Company's website for
approximately 60 days after the call.
About Agenus
Agenus is an immuno-oncology company focused on the discovery
and development of revolutionary new treatments that engage the
body's immune system to benefit patients suffering from cancer. By
combining multiple powerful platforms, Agenus has established a
highly integrated approach for the discovery, development and
manufacture of monoclonal antibodies that modulate targets of
interest. In addition, the Company's cancer vaccine program
includes three proprietary platforms focused on individualized and
off-the-shelf vaccines uniquely designed for each patient. Agenus'
broad portfolio of novel checkpoint and other immuno-modulatory
monoclonal antibodies, vaccines and adjuvants work in combination
to provide the opportunity to create best-in-class therapeutic
regimens. The Company has formed collaborations with Merck and
Incyte to discover and develop multiple checkpoint antibodies. For
more information, please visit www.agenusbio.com; information that
may be important to investors will be routinely posted on our
website.
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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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2016
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2015
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2016
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2015
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Revenue
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$
4,446
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$
6,848
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$
16,997
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$
17,178
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Operating
expenses:
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Research and
development
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21,588
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18,502
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68,988
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52,495
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General and
administrative
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8,107
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6,408
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24,456
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19,910
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Non-cash contingent
consideration fair value adjustment
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10,975
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(6,994)
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11,354
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7,327
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Operating
loss
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(36,224)
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(11,068)
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(87,801)
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(62,554)
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Other expense,
net
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(4,549)
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(2,054)
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(13,071)
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(9,720)
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Net loss
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(40,773)
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(13,122)
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(100,872)
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(72,274)
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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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(153)
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(152)
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Net loss attributable
to common stockholders
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$
(40,824)
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$
(13,173)
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$
(101,025)
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$
(72,426)
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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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$
(0.47)
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$
(0.16)
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$
(1.16)
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$
(0.95)
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Weighted average
number of common shares outstanding, basic and diluted
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87,207
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84,569
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86,954
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75,936
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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,
2016
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December 31,
2015
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Cash, cash
equivalents and short-term investments
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$
95,399
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$
171,668
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Total
assets
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174,842
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242,228
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Total stockholders'
(deficit) equity
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(21,039)
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70,728
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Forward-Looking Statement
This press release contains forward-looking statements that are
made pursuant to the safe harbor provisions of the federal
securities laws, including statements regarding the Company's
intent to commercialize products in the next five years, near-term
milestones and product candidates and clinical trial plans. 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 Agenus' Form 10-Q filed with the
Securities and Exchange Commission on August
4, 2016. 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.
Michelle Linn, 781-674-4541
michelle.linn@agenusbio.com
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SOURCE Agenus Inc.