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
Date
of Report (Date of earliest event reported):February 20, 2015
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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Registrant’s
telephone number, including area code 781-674-4400
N/A
(Former
Name or Former Address, if Changed Since Last Report)
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 2.03 Creation of a Direct Financial Obligation or an Obligation
under an Off-Balance Sheet Arrangement of a Registrant.
As previously disclosed, Agenus Inc. (the “Company”) is party to a Note
Purchase Agreement dated April 15, 2013, pursuant to which the Company
issued to certain investors (the “Existing Investors”) (i) senior
subordinated promissory notes in the aggregate principal amount of $5.0
million that were scheduled to mature on April 14, 2015 (the “2013
Notes”) and (ii) warrants to purchase 500,000 shares of the Company’s
common stock.
On February 20, 2015, the Company, the Existing Investors and certain
additional investors entered into an Amended and Restated Note Purchase
Agreement (the “Purchase Agreement”), pursuant to which the Company (i)
cancelled the 2013 Notes in exchange for new senior subordinated
promissory notes (the “2015 Notes”) in the aggregate principal amount of
$5.0 million, (ii) issued additional 2015 Notes in the aggregate
principal amount of $9.0 million and (iii) issued warrants to purchase
1,400,000 shares of the Company’s common stock (the “Warrants”).
The 2015 Notes bear interest at a rate of 8% per annum, payable in cash
on the first day of each month in arrears. Among other default and
acceleration terms customary for indebtedness of this type, the 2015
Notes include default provisions which allow for the acceleration of the
principal payment of the 2015 Notes in the event the Company becomes
involved in certain bankruptcy proceedings, becomes insolvent, fails to
make a payment of principal or (after a grace period) interest on the
2015 Notes, defaults on other indebtedness with an aggregate principal
balance of $13.5 million or more if such default has the effect of
accelerating the maturity of such indebtedness, or becomes subject to a
legal judgment or similar order for the payment of money in an amount
greater than $13.5 million if such amount will not be covered by
third-party insurance. The 2015 Notes are not convertible and will
mature on February 20, 2018, at which point the Company must repay the
outstanding balance in cash. The Company may prepay the 2015 Notes at
any time, in part or in full, without premium or penalty.
The Warrants have a term of five years and an exercise price of $5.10
per share.
The securities issued in connection with the Purchase Agreement were
issued in reliance on the exemption from registration provided by
Section 4(2) of the Securities Act of 1933, as amended (the “Securities
Act”). Neither the Warrants nor the underlying shares of common stock
have been registered under the Securities Act. Neither the Warrants nor
such underlying shares of common stock may be offered or sold in the
United States absent registration or an applicable exemption from
registration requirements. No commission or other remuneration was paid
or given directly or indirectly for soliciting such issuance.
Item 2.02 Results of Operations and Financial Condition.
On February 26, 2015, the Company announced its financial results for
the quarter and year ended December 31, 2014. 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.
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.
Item 3.02 Unregistered Sales of Equity Securities.
The information provided above under Item 2.03 of this Current Report on
Form 8-K is hereby incorporated by reference into this Item 3.02.
Item 5.02 Departure of Directors or Certain Officers; Election of
Directors; Appointment of Certain Officers; Compensatory Arrangements of
Certain Officers.
(b) On February 23, 2015, Tom Dechaene, a member of the Company’s board
of directors (the “Board”), informed the Company of his intention to
resign from the Board effective as of December 31, 2015. Mr. Dechaene
will continue to serve as a director until such date. Mr. Dechaene’s
decision is required by his role as an executive director of the
National Bank of Belgium and is not due to any disagreement with the
Company on any matter relating to the Company’s operations, policies or
practices.
Item 9.01 Financial Statements and Exhibits.
(d)
Exhibits
The following exhibit is furnished herewith:
99.1 Press
Release dated February 26, 2015
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:
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February 26, 2015
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By:
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/s/ Garo H. Armen
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Garo H. Armen
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Chairman and CEO
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EXHIBIT INDEX
Exhibit No. Description
of Exhibit
99.1 Press Release dated
February 26, 2015
Exhibit 99.1
Agenus
Reports Fourth Quarter and Full Year 2014 Financial Results
Agenus
to host conference call at 11 a.m. ET today
LEXINGTON, Mass.--(BUSINESS WIRE)--February 26, 2015--Agenus Inc.
(NASDAQ:AGEN), an immunology company developing novel therapeutic
approaches based on checkpoint modulators (CPMs), heat shock
protein-based vaccines, and immune adjuvants, today announced its
financial results and business highlights for the fourth quarter and
year ended December 31, 2014.
“2014 was a transformative year for Agenus on many levels,” said Garo H.
Armen, Ph.D., Chairman and CEO of Agenus. “We started the year with the
acquisition of privately held 4-Antibody AG, which brought us into the
critically important field of checkpoint modulators. Through this
acquisition, Agenus acquired our Retrocyte DisplayTM
technology, for the generation of antibody therapeutics, as well as a
broad portfolio of checkpoint programs. In April, we announced a
collaboration and license agreement with Merck around two undisclosed
checkpoint targets, with Agenus eligible to receive up to $100 million
in milestone payments as well as royalties on product sales. In June, we
reported positive data from a Phase 2 study of our heat shock
protein-based synthetic vaccine (HerpV) for the treatment of genital
herpes, and shortly thereafter we announced positive results from a
Phase 2 study of our heat shock-protein-based autologous vaccine
(Prophage) in patients with newly diagnosed glioblastoma multiforme
(GBM). In addition, our partner GlaxoSmithKline’s application for
regulatory review of its malaria vaccine candidate, RTS,S, was accepted
by the European Medicines Agency. The application was based on positive
Phase 3 data for RTS,S, which contains Agenus’ proprietary QS-21 Stimulon®
adjuvant. In December, GlaxoSmithKline reported that its Phase 3 study
with shingles vaccine candidate HZ/su, which also contains Agenus’
proprietary QS-21 Stimulon® adjuvant, met its primary
endpoint and reduced the risk of shingles by an unprecedented 97.2% in
adults aged 50 years and older compared to placebo. Building on our
achievements in 2014, we started 2015 with a transformative global
oncology alliance with Incyte that includes, but is not limited to, four
of our checkpoint programs. We look forward to executing on our
alliances with Incyte and Merck, and expanding our portfolio of
antibody-based therapeutics as we pursue the development of novel single
agent and combination therapies for cancer patients.”
“Supporting these initiatives has required a growth in the breadth and
depth of our R&D capabilities, including the assembly of a world-class
translational biology team,” said Robert Stein, M.D., Ph.D., Chief
Scientific Officer of Agenus. “We believe our partnership with Incyte
leverages their track record of success in the discovery and development
of important new cancer therapies, with our therapeutic antibody
expertise, as well as our shared objectives in immuno-oncology. Our
alliance aims to accelerate the development of novel checkpoint
modulators in oncology, as single agent and combination therapies, while
also allowing Agenus the ability to independently advance other antibody
therapies and heat shock protein-based vaccines.”
Fourth Quarter 2014 and Full Year Financial Update
Cash, cash equivalents and short-term investments were $40.2 million as
of December 31, 2014. Subsequent to year-end, the company received an
additional $60 million from its global alliance with Incyte.
For the fourth quarter, Agenus reported a net loss attributable to
common stockholders of $26.0 million, including $14.3 million of
non-cash charges, or $0.41 per share, basic and diluted, compared with a
net loss attributable to common stockholders for the fourth quarter of
2013 of $5.8 million, or $0.16 per share, basic and diluted.
For the year ended December 31, 2014, the company incurred a net loss
attributable to common stockholders of $42.7 million, or $0.71 per
share, basic and diluted, compared with a net loss attributable to
common stockholders of $33.2 million, or $1.12 per share, basic and
diluted, for the comparable period in 2013.
The increase in net loss attributable to common stockholders for the
year ended December 31, 2014, compared to the net loss attributable to
common stockholders for the same period in 2013, was primarily due to
our acquisition of 4-Antibody AG in February 2014. In addition to
increased operating expenses, we recorded non-cash expense of $6.7
million due to the fair value adjustment of the contingent purchase
price consideration and non-cash income of $3.1 million related to the
results of various trials of QS-21 Stimulon containing vaccines at
GlaxoSmithKline.
During the same period of 2013, the company’s preferred stock
restructuring resulted in a non-cash deemed dividend of $2.9 million,
and the retirement of its then outstanding $39 million 8.0% senior
secured convertible notes due August 2014 resulted in a non-cash expense
of $3.3 million.
The increased net loss attributable to common stockholders for the
quarter ended December 31, 2014, compared to the net loss attributable
to common stockholders for the same period in 2013, was as well due to
increased expenses related to our acquisition of 4-Anitbody AG. We also
recorded non-cash expenses for the quarter ended December 31, 2014 of
$6.6 million, due to the fair value adjustment of the contingent
purchase price consideration, and $7.7 million related to the fair value
adjustment of our contingent royalty obligation.
2014 Highlights:
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January: Agenus signed a definitive agreement to acquire
privately held 4-Antibody AG, with its proprietary Retrocyte DisplayTM
technology and a broad preclinical portfolio of checkpoint modulators
targeting GITR, OX40, TIM-3 and LAG-3, among others. The acquisition
closed in February 2014.
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February: Agenus closed a public offering that resulted in net
proceeds of approximately $56 million.
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April: Agenus entered into a collaboration and license
agreement with Merck, involving generation by Agenus of fully human
antibodies against two undisclosed checkpoint targets from Merck, in
exchange for up to $100 million in potential milestones, as well as
royalties on worldwide product sales.
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June: Agenus announced positive data from a randomized double
blind Phase 2 study involving its heat shock protein-based vaccine
candidate, HerpV, for the treatment of adult genital herpes. The study
showed a statistically significant reduction in viral load in the more
than half of patients who generated a robust anti-HSV cytotoxic T-cell
immune response.
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July: Agenus announced positive data from a single arm Phase 2
study involving its heat shock protein-based autologous vaccine,
Prophage, in the setting of GBM. The data showed patients treated with
Prophage achieved a median overall survival of 23.8 months, compared
with the historical expectation of about 16 months median survival
with the standard of care. Subsequently, an end of Phase 2 meeting was
held with the FDA.
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July: The EMA accepted GlaxoSmithKline’s application for
regulatory review of its malaria vaccine candidate, RTS,S, based on
positive data from a large Phase 3 study involving over 16,000
children. The vaccine contains Agenus’ proprietary QS-21 Stimulon®
adjuvant, and Agenus is eligible to receive low single digit royalties
on any future product sales.
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December: Agenus announced positive data from our partner
GlaxoSmithKline’s ZOE-50 Phase 3 trial involving its HZ/su vaccine
candidate for the prevention of shingles in adults aged 50 and over.
The study showed an unprecedented 97.2% efficacy rate in the
prevention of shingles compared to placebo. Full study results will be
submitted for publication this year and presented at a forthcoming
medical conference. The vaccine candidate contains Agenus’ proprietary
QS-21 Stimulon® adjuvant, and Agenus is eligible to receive low single
digit royalties on any future product sales.
Target Milestones for 2015 include:
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Publication of the Phase 2 data for Prophage in newly diagnosed GBM in
a peer reviewed journal. Explore options for the advancement of
Prophage for newly diagnosed GBM to a Phase 3 trial.
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Full Phase 3 data for partner GlaxoSmithKline’s HZ/su shingles vaccine
are expected to be presented at a scientific conference and submitted
for publication in a peer-reviewed journal. The vaccine contains
Agenus’ proprietary QS-21 Stimulon® adjuvant.
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EMA regulatory decision on GlaxoSmithKline’s malaria vaccine candidate
RTS,S, which contains Agenus’s QS-21 Stimulon® adjuvant.
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File Investigational New Drug (IND) applications for two checkpoint
modulator antibody programs as part of our global oncology alliance
with Incyte.
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 live and archived webcast of the presentation will
be accessible from the Company’s website at www.agenusbio.com/webcast.
Please log in approximately 5-10 minutes before the call to ensure a
timely connection. The archived replay will be available on the Agenus
website for 60 days. The replay number is 866-245-6755 (U.S.) or
416-915-1035 (international), and the access code is 55109. The replay
will also be available on the Company’s website approximately two hours
after the live call.
About Agenus
Agenus is an immunology company developing a series of immuno-oncology
CPMs, heat shock protein peptide-based vaccines and immune adjuvants.
These programs are supported by three separate technology platforms.
Agenus’ checkpoint modulator programs target GITR, OX40, CTLA-4, LAG-3,
TIM-3 and PD-1. The Company’s proprietary discovery engine Retrocyte
DisplayTM is used to generate fully human and humanized
therapeutic antibody drug candidates. The Retrocyte DisplayTM
platform uses a high-throughput approach incorporating IgG format human
antibody libraries expressed in mammalian B-lineage cells. Agenus’ heat
shock protein vaccines have completed Phase 2 studies in newly diagnosed
glioblastoma multiforme, and in the treatment of herpes simplex viral
infection; the heat shock protein 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 Janssen
Sciences Ireland UC and includes several candidates in Phase 2, 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+.
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 Incyte and
Merck, 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 December 31,
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Year ended December 31,
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2014
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2013
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2014
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2013
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Revenue
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$
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1,619
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$
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393
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$
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6,977
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$
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3,045
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Operating expenses:
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Cost of revenue
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-
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7
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-
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536
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Research and development
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7,369
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3,241
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22,349
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13,005
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General and administrative
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5,374
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3,372
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21,250
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14,484
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Non-cash contingent consideration fair value adjustment
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6,535
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-
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6,699
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-
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Operating loss
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|
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(17,659
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)
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|
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(6,227
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)
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(43,321
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)
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(24,980
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)
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Other income (expense), net
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(8,319
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)
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450
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835
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(5,093
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)
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Net loss
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(25,978
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)
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(5,777
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)
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(42,486
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)
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(30,073
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)
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Dividends on Series A convertible preferred stock
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(51
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)
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(50
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)
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(204
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)
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(3,159
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)
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Net loss attributable to common stockholders
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$
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(26,029
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)
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|
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$
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(5,827
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)
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$
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(42,690
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)
|
|
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$
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(33,232
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)
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|
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|
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|
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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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$
|
(0.41
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)
|
|
|
$
|
(0.16
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)
|
|
$
|
(0.71
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)
|
|
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$
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(1.12
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)
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Weighted average number of common shares outstanding, basic and
diluted
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62,849
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|
|
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35,676
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|
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59,754
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|
|
|
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29,766
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|
|
|
|
|
|
|
|
|
|
|
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CONDENSED CONSOLIDATED BALANCE SHEET DATA
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(in thousands)
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(Unaudited)
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|
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December 31, 2014
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December 31, 2013
|
|
|
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|
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Cash, cash equivalents and short-term investments
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$
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40,224
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$
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27,352
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Total assets
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74,527
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34,835
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Total stockholders' equity (deficit)
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23,018
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(4,481
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)
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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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