UNITED
STATES
SECURITIES
AND EXCHANGE COMMISSION
Washington,
D.C. 20549
FORM 8-K
CURRENT
REPORT
Pursuant
to Section 13 or 15(d) of
the Securities Exchange Act of 1934
April
23, 2015
Date
of Report (Date of earliest event reported)
AGENUS INC.
(Exact
name of registrant as specified in its charter)
DELAWARE
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000-29089
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06-1562417
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(State or other jurisdiction
of incorporation)
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(Commission
File Number)
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(IRS Employer
Identification No.)
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3 Forbes Road
Lexington, MA
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02421
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(Address
of principal executive offices)
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(Zip
Code)
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781-674-4400
(Registrant’s
telephone number, including area code)
Check the appropriate box below if the Form 8-K filing is intended to
simultaneously satisfy the filing obligation of the registrant under any
of the following provisions (see General Instruction A.2. below):
⃞
Written
communications pursuant to Rule 425 under the Securities Act (17 CFR
230.425)
⃞
Soliciting
material pursuant to Rule 14a-12 under the Exchange Act (17 CFR
240.14a-12)
⃞
Pre-commencement
communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR
240.14d-2(b))
⃞
Pre-commencement
communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR
240.13e-4(c))
Item 2.02
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Results of Operations and Financial Condition.
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On April 23, 2015, Agenus Inc. announced its financial results for
the quarter ended March 31, 2015. The full text of the press release
issued in connection with the announcement is being furnished as
Exhibit 99.1 to this current report on Form 8-K.
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The information set forth under Item 2.02 and in Exhibit 99.1
attached hereto is intended to be furnished and shall not be deemed
“filed” for purposes of Section 18 of the Securities Exchange Act of
1934 or otherwise subject to the liabilities of that section, nor
shall it be deemed incorporated by reference in any filing under the
Securities Act of 1933, except as expressly set forth by specific
reference in such filing.
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Item 9.01
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Financial Statements and Exhibits.
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(d) Exhibits
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The following exhibit is furnished herewith:
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99.1 Press Release dated April 23, 2015
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SIGNATURES
Pursuant to
the requirements of the Securities Exchange Act of 1934, the Registrant
has duly caused this report to be signed on its behalf by the
undersigned hereunto duly authorized.
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AGENUS INC.
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Date: April 23, 2015
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By:
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/s/ Christine M. Klaskin
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Christine M. Klaskin
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VP, Finance
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EXHIBIT INDEX
Exhibit No.
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Description of Exhibit
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99.1
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Press Release dated April 23, 2015
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Exhibit 99.1
Agenus
Reports First Quarter 2015 Financial Results
Corporate
Update Conference Call at 11 am ET Today
Agenus
to Host R&D Day in New York, NY on May 14
LEXINGTON, Mass.--(BUSINESS WIRE)--April 23, 2015--Agenus Inc.
(NASDAQ:AGEN), an immunotherapy company developing immune-oncology
checkpoint modulators (CPMs) and heat shock protein peptide-based
vaccines as well as immune adjuvants, today announced its financial
results for the first quarter ended March 31, 2015.
“We began the year by establishing a strategic alliance with Incyte,
focused on the development of novel cancer treatments targeting immune
checkpoints. During the quarter, we also advanced our internal and
partnered antibody programs,” said Garo H. Armen, Ph.D., Chairman and
CEO of Agenus. “Our recent acquisition of Celexion’s SECANT® yeast
display antibody platform and related assets expands our antibody
discovery platform and, together with our mammalian Retrocyte Display™
platform, provides a uniquely powerful means to maximize speed and
flexibility in antibody generation and optimization. Finally, we look
forward to filing INDs on two CPMs by the end of this year, and to
progressing our immune-oncology alliance with Merck, while also
exploring other potential corporate alliances.”
First Quarter 2015 Financial Results
The Company’s cash burn (cash provided by operating activities excluding
up-front fees received and contingent purchase price payments) for the
first quarter of 2015 was $10.7 million compared to $10.1 million for
the same period in 2014. For the first quarter ended March 31, 2015,
Agenus reported a net loss attributable to common stockholders of $18.7
million, or $0.28 per share, basic and diluted, compared with a net loss
attributable to common stockholders for the first quarter of 2014 of
$409,000, or $0.01 per share, basic and diluted.
The increase in net loss attributable to common stockholders for the
quarter ended March 31, 2015, compared to the net loss attributable to
common stockholders for the same period in 2014, was primarily due to
non-cash, fair value adjustments of our contingent liabilities in 2015
and non-cash, non-operating income during the quarter ended March 31,
2014 .
Cash and cash equivalents were $79.3 million as of March 31, 2015.
First Quarter 2015 and Recent Corporate Highlights
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In January, Agenus Inc. and Incyte Corporation formed a global
alliance focused on novel immuno-therapeutics using Agenus’
proprietary Retrocyte Display™ antibody discovery platform. Agenus
received $60 million upfront, comprised of $25 million in license and
program access fees plus a $35 million equity investment in Agenus.
Agenus is eligible to receive up to $350 million in development,
regulatory and commercial milestones across the four lead programs.
The collaboration is initially focused on the development of
checkpoint modulator antibodies directed against GITR, OX40, LAG-3 and
TIM-3. The partnership leverages Incyte’s track record of success in
the discovery and development of important new cancer therapies and
Agenus’ therapeutic antibody expertise to optimize and develop novel
checkpoint modulators in oncology, while allowing Agenus the ability
to independently advance other antibody therapies and its heat shock
protein-based vaccines. Incyte and Agenus will share equally in costs
and profits for GITR and OX40. For royalty-bearing products, Agenus is
eligible to receive tiered royalties on global net sales ranging from
6-12%. In April, Agenus acquired key antibody assets from Celexion,
LLC, including the SECANT® yeast display platform for the rapid
generation of novel, full-length human monoclonal antibodies. The
Celexion yeast antibody display platform and Agenus’ mammalian
antibody display platform have complementary strengths and together
bolster Agenus' antibody capabilities. The acquired assets also
include Celexion’s novel approaches to identify and characterize
antibodies against membrane bound protein targets such as GPCRs and
ion channels in a highly efficient manner.
Target Milestones for 2015
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Submission to a peer review journal of Phase 2 data for Prophage in
newly diagnosed GBM by our academic collaborators.
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Advancement of Prophage to a Phase 3 trial for newly diagnosed GBM.
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Potential presentation of Phase 3 data for partner GlaxoSmithKline’s
HZ/su shingles vaccine at a scientific conference. The vaccine
contains Agenus’ proprietary QS-21 Stimulon® adjuvant. Agenus is
eligible to receive low single-digit royalties on potential commercial
sales of GSK’s shingles vaccine.
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EMA regulatory decision on GlaxoSmithKline’s malaria vaccine candidate
RTS,S, which contains Agenus’s QS-21 Stimulon® adjuvant. Agenus is
eligible to receive low single-digit royalties on potential commercial
sales of GSK’s malaria vaccine.
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Investigational New Drug (IND) application filings for two checkpoint
modulator antibody programs by Agenus or Incyte.
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Leverage Agenus capabilities through further corporate partnerships.
Conference Call and Web Cast Information
Agenus executives will host a conference call at 11:00 a.m. Eastern Time
today. To access the live call, dial 866-233-4585 (U.S.) or 416-640-5946
(international). The call will also be webcast and will be accessible
from the company’s website at www.agenusbio.com/webcast/. A
replay will be available on the company’s website approximately two
hours after the call and will remain available for 60 days. The replay
number is 866-245-6755 (U.S.) or 416-915-1035 (international), and the
access code is 601129. The replay will also be available on the
company’s website approximately two hours after the live call.
Research & Development Day Information
Agenus will be hosting a Research and Development Day on May 14th
in New York City at 4:30pm. The Company intends to provide the financial
community with a detailed update on our internal and partnered R&D
efforts, as well as on major advances, challenges and opportunities
around the development of immuno-oncology therapies focused on
checkpoint modulators. Guest presenters will include Charles Drake,
M.D., Ph.D., Co-Director at the Prostate Cancer Multidisciplinary Clinic
and Associate Professor of Oncology, Urology, and Immunology at the
Johns Hopkins School of Medicine, and Orin Bloch, M.D., Khatib Professor
of Neurological Surgery at Northwestern University Feinberg School of
Medicine. The event will also be webcast live and will be accessible
from the company’s website at www.agenusbio.com/webcast/.
About Agenus
Agenus is an immunology company developing a series of Checkpoint
Modulators for the treatment of patients with cancer, infectious
diseases, and other immune disorders, heat shock protein (HSP)-based
vaccines, and immune adjuvants. These programs are supported by three
separate technology platforms. Agenus’ internal and partnered checkpoint
modulator programs target GITR, OX40, CTLA-4, LAG-3, TIM-3, PD-1 and
other undisclosed programs. The company’s proprietary discovery engine
Retrocyte DisplayTM is used to generate fully human and
humanized therapeutic antibody drug candidates. The Retrocyte Display
platform uses a high-throughput approach incorporating IgG format human
antibody libraries expressed in mammalian B-lineage cells. Agenus
recently acquired a powerful yeast antibody display platform termed
SECANT, developed by Celexion. SECANT allows rapid generation of
soluble, full-length human antibodies. SECANT and Agenus’ mammalian
antibody display platform have complementary strengths and further
bolster Agenus' abilities to generate and optimize fully human
monoclonal antibodies. Agenus’ heat shock protein-based vaccines have
completed Phase 2 studies in newly diagnosed glioblastoma multiforme,
and in the treatment of herpes simplex viral infection; the heat shock
protein-based vaccine platform can generate personalized as well as off
the shelf products. The company’s QS-21 Stimulon® adjuvant platform is
extensively partnered with GlaxoSmithKline and with Janssen Sciences
Ireland UC and includes several candidates in Phase 2 trials, as well as
shingles and malaria vaccines which have successfully completed Phase 3
clinical trials. For more information, please visit www.agenusbio.com,
or connect with the company on Facebook, LinkedIn, Twitter and Google+;
information that may be important to investors will be routinely posted
in these locations.
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 research and development
and clinical trial activities, potential revenue streams, potential
regulatory approvals, the potential application of the Company’s
technologies and product candidates in the prevention and treatment of
diseases, plans to execute on the Company’s alliances with existing
partners and potentially enter into new alliances, the expected timing
for filing IND applications for CPM antibody candidates, the submission
and publication of data in peer-reviewed journals and presentations of
data at scientific conferences. 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.
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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 March 31,
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2015
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2014
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Revenue
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$
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3,953
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$
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721
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Operating expenses:
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Research and development
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9,220
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4,473
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General and administrative
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5,487
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5,163
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Non-cash contingent consideration fair value adjustment
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7,538
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909
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Operating loss
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(18,292
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(9,824
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Other income (expense), net
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(450
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)
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9,467
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Net loss
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(18,742
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)
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(357
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)
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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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Net loss attributable to common stockholders
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$
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(18,793
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$
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(408
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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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$
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(0.28
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$
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(0.01
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Weighted average number of common shares outstanding, basic and
diluted
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66,667
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50,557
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Condensed Consolidated Balance Sheet Data
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(in thousands)
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(unaudited)
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March 31, 2015
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December 31, 2014
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Cash and cash equivalents
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$
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79,304
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$
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40,224
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Total assets
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117,324
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74,527
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Total stockholders' equity
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46,259
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23,018
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CONTACT:
Agenus Inc.
Media:
BMC Communications
Brad
Miles, 646-513-3125
bmiles@bmccommunications.com
or
Investors:
Argot
Partners
Andrea Rabney/ Jamie Maarten, 212-600-1902
andrea@argotpartners.com
jamie@argotpartners.com
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