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
July
23, 2015
Date
of Report (Date of earliest event reported)
AGENUS INC.
(Exact
name of registrant as specified in its charter)
DELAWARE
|
000-29089
|
06-1562417
|
(State or other jurisdiction
of incorporation)
|
(Commission
File Number)
|
(IRS Employer
Identification No.)
|
3 Forbes Road
Lexington, MA
|
02421
|
(Address
of principal executive offices)
|
(Zip
Code)
|
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
|
|
Results of Operations and Financial Condition.
|
|
|
|
|
|
On July 23, 2015, Agenus Inc. announced its financial results for
the quarter ended June 30, 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.
|
|
|
|
|
|
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 9.01
|
|
Financial Statements and Exhibits.
|
(d) Exhibits
The following exhibit is furnished herewith:
|
99.1 Press Release dated July 23, 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.
|
AGENUS INC.
|
|
|
Date: July 23, 2015
|
By:
|
/s/ C. Evan Ballantyne
|
|
|
|
C. Evan Ballantyne
|
|
Chief Executive Officer
|
EXHIBIT INDEX
Exhibit No.
|
|
Description of Exhibit
|
|
|
|
99.1
|
|
Press Release dated July 23, 2015
|
Exhibit 99.1
Agenus
Reports Second Quarter 2015 Financial Results
Corporate
Update Conference Call at 11 am ET Today
LEXINGTON, Mass.--(BUSINESS WIRE)--July 23, 2015--Agenus Inc.
(NASDAQ:AGEN), an immunology company discovering and developing
innovative treatments for cancers and other diseases, today announced
its financial results for the second quarter ended June 30, 2015.
“During the second quarter, we made meaningful advances across all areas
of our business which include our proprietary clinical-stage programs,
our immuno-oncology portfolio, strategic acquisitions and our balance
sheet,” said Dr. Garo H. Armen, Chairman and CEO of Agenus. “Of note, we
presented updated Phase 2 results at ASCO for our autologous heat shock
protein vaccine, Prophage, in newly diagnosed glioblastoma multiforme,
demonstrating impressive median overall survival for patients with low
levels of PD-L1 on their monocytes at baseline, compared to historical
standard of care data. Our recent acquisition of novel CEACAM1
antibodies reflects our continued commitment to build a broad, yet
complementary, portfolio of immuno-modulators with the potential to
create best-in-class combination therapies for the treatment of cancer.
This was preceded by our acquisition in April of the SECANT®
yeast display platform from Celexion, a platform which is complementary
to our Retrocyte DisplayTM platform, and which will allow us
to enhance the speed and efficiency of our antibody generation. We
expanded our management team including the addition of Evan Ballantyne
as our CFO, and we successfully raised $74.6 million in net proceeds
from a public offering in May to support further development of our
programs. Looking ahead, we are on track to deliver on our milestones
for 2015, including the filing of two IND’s for check point modulator
programs by year end and advancing Prophage into a Phase 3 study in
newly diagnosed glioblastoma.”
Second Quarter 2015 Financial Results
The company reported a
net loss attributable to common stockholders of $40.5 million, or $0.53
per share, basic and diluted, for the second quarter ended June 30, 2015
compared with a net loss attributable to common stockholders for the
second quarter of 2014 of $7.8 million, or $0.12 per share, basic and
diluted.
For the six months ended June 30, 2015, the company reported a net loss
attributable to common stockholders of $59.3 million, or $0.83 per
share, basic and diluted, compared with a net loss attributable to
common stockholders of $8.5 million, $0.15 per share, basic and diluted,
for the six months ended June 30, 2014.
The increase in net loss attributable to common stockholders for the six
months ended June 30, 2015, compared to the net loss attributable to
common stockholders for the same period in 2014, was primarily due to
the advancement of the check point modulator programs, the $20.7 million
non-cash expense from fair value adjustments of the contingent
obligations and the $13.2 million charge for the purchase of the SECANT
yeast display platform in 2015. During the same period in 2014, the
company recorded non-cash non-operating income of $11.0 million related
to the fair value adjustment of a contingent obligation.
Cash, cash equivalents and short-term investments were $139.6 million as
of June 30, 2015.
Second Quarter 2015 and Recent Corporate Highlights
-
In July, Agenus announced the acquisition of novel antibodies
targeting Carcinoembryonic Antigen Cell Adhesion Molecule 1 (CEACAM1)
from Diatheva s.r.l., an Italian biotech company controlled by SOL
S.pA.
-
In June, Agenus announced the appointment of C. Evan Ballantyne as the
Company’s Chief Financial Officer.
-
In June, Merck and Agenus extended the research term of their existing
collaboration and licensing agreement by one year to April 2016,
allowing Agenus to discover and optimize fully human antibodies
against two undisclosed Merck checkpoint targets.
-
At the 2015 ASCO meeting in June, Orin Bloch, M.D. presented updated
Phase 2 survival data for Prophage, Agenus’ individualized heat shock
protein-based cancer vaccine, in newly diagnosed Glioblastoma
Multiforme (GBM) patients. In patients who had less PD-L1 expression
on their white blood cells (monocytes) at baseline, the median Overall
Survival was approximately 45 months, with more than one-third of
these patients alive without progression for more than three years.
-
In May, the company completed a public offering of 12,650,000 shares
of common stock, offered at $6.30 per share, which includes the
exercise in full by the underwriters of their option to purchase
1,650,000 additional shares of common stock. The offering resulted in
net proceeds in of $74.6 million.
-
In April, Agenus acquired the SECANT® yeast display platform for the
generation of novel monoclonal antibodies from Celexion LLC, a
privately held biotech company in Cambridge, MA. The acquired assets
also include Celexion’s novel approaches to generate antibodies
against membrane bound protein targets such as G protein–coupled
receptors and ion channels, which will be used to assess antibody
binding and help determine functional attributes of agonist and
antagonist antibodies in a highly efficient manner.
-
In April, primary and secondary endpoint data from GlaxoSmithKline’s
(GSK) successful Phase 3 trial of HZ/su, a vaccine candidate for the
prevention of shingles in adults age 50 or over, were simultaneously
presented at the 25th Scientific Conference of the European Society of
Clinical Microbiology and Infectious Disease in Copenhagen, and
published in the New England Journal of Medicine. GSK’s
HZ/su incorporates Agenus' QS-21 Stimulon® adjuvant, which is designed
to increase immune response to antigens. The vaccine demonstrated a
97.2% rate of prevention of the onset of shingles in the study
population over four years.
-
In April, final results from the successful Phase 3 study of GSK’s
malaria vaccine candidate, RTS,S, which also incorporates QS-21
Stimulon, were published in The Lancet.
Target Milestones for 2015
-
Submission to a peer reviewed journal of the Phase 2 data for Prophage
in newly diagnosed GBM. Advancement of Prophage for newly diagnosed
GBM to a Phase 3 trial.
-
EMA regulatory decision on GSK’s malaria vaccine candidate RTS,S,
which contains Agenus’s QS-21 Stimulon. Agenus is eligible to receive
low single-digit royalties on potential sales of GSK’s malaria vaccine.
-
File Investigational New Drug (IND) applications for two checkpoint
modulator antibody programs, one of which is part of our alliance with
Incyte.
-
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 1-866-233-4585 (U.S.) or
1-416-640-5946 (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 1-866-245-6755 (U.S.) 1-416-915-1035 (international), and the
access code is 857826.
About Agenus
Agenus is an immunology company discovering and developing novel
checkpoint modulators, vaccines and adjuvants to treat cancer and other
diseases. Using its proprietary platforms Retrocyte DisplayTM
and SECANT®, the Company is discovering and developing novel antibodies
to target GITR, OX40, CTLA-4, LAG-3, TIM-3, PD-1 and other undisclosed
checkpoints in partnered and internal programs. Agenus’ heat shock
protein vaccine, Prophage, has successfully completed Phase 2 studies in
newly diagnosed glioblastoma multiforme. The Company’s QS-21 Stimulon®
adjuvant is extensively partnered with GlaxoSmithKline plc and Janssen
Sciences Ireland Uc, and two vaccine candidates containing QS-21 have
successfully completed Phase 3 trials. For more information, please
visit www.agenusbio.com, or follow the company on Twitter
@Agenus_Bio; 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 Agenus’ target milestones for 2015. 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 Prospectus Supplement filed with the
Securities and Exchange Commission on May 21, 2015. 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.
|
Summary Consolidated Financial Information
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Condensed Consolidated Statements of Operations Data
|
(in thousands, except per share data)
|
(unaudited)
|
|
|
|
|
|
|
|
|
|
|
|
Three months ended June 30,
|
|
Six months ended June 30,
|
|
|
2015
|
|
2014
|
|
2015
|
|
2014
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Revenue
|
|
$
|
6,377
|
|
|
$
|
3,074
|
|
|
$
|
10,330
|
|
|
$
|
3,795
|
|
|
|
|
|
|
|
|
|
|
Operating expenses:
|
|
|
|
|
|
|
|
|
Research and development
|
|
|
24,773
|
|
|
|
5,223
|
|
|
|
33,993
|
|
|
|
9,695
|
|
General and administrative
|
|
|
8,016
|
|
|
|
5,847
|
|
|
|
13,503
|
|
|
|
11,290
|
|
Non-cash contingent consideration fair value adjustment
|
|
|
6,783
|
|
|
|
224
|
|
|
|
14,321
|
|
|
|
1,133
|
|
|
|
|
|
|
|
|
|
|
Operating loss
|
|
|
(33,195
|
)
|
|
|
(8,220
|
)
|
|
|
(51,487
|
)
|
|
|
(18,323
|
)
|
|
|
|
|
|
|
|
|
|
Other (expense) income, net
|
|
|
(7,215
|
)
|
|
|
458
|
|
|
|
(7,665
|
)
|
|
|
9,924
|
|
|
|
|
|
|
|
|
|
|
Net loss
|
|
|
(40,410
|
)
|
|
|
(7,762
|
)
|
|
|
(59,152
|
)
|
|
|
(8,399
|
)
|
|
|
|
|
|
|
|
|
|
Dividends on Series A-1 convertible preferred stock
|
|
|
(51
|
)
|
|
|
(51
|
)
|
|
|
(101
|
)
|
|
|
(102
|
)
|
|
|
|
|
|
|
|
|
|
Net loss attributable to common stockholders
|
|
$
|
(40,461
|
)
|
|
$
|
(7,813
|
)
|
|
$
|
(59,253
|
)
|
|
$
|
(8,501
|
)
|
|
|
|
|
|
|
|
|
|
Per common share data, basic and diluted:
|
|
|
|
|
|
|
|
|
Net loss attributable to common stockholders
|
|
$
|
(0.53
|
)
|
|
$
|
(0.12
|
)
|
|
$
|
(0.83
|
)
|
|
$
|
(0.15
|
)
|
Weighted average number of common shares outstanding, basic and
diluted
|
|
|
76,375
|
|
|
|
62,608
|
|
|
|
71,548
|
|
|
|
56,616
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Condensed Consolidated Balance Sheet Data
|
|
|
(in thousands)
|
|
|
(unaudited)
|
|
|
|
|
|
|
|
June 30, 2015
|
|
December 31, 2014
|
|
|
|
|
|
Cash, cash equivalents and short-term investments
|
|
$
|
139,642
|
|
$
|
40,224
|
Total assets
|
|
|
180,110
|
|
|
74,527
|
Total stockholders' equity
|
|
|
87,190
|
|
|
23,018
|
|
|
|
|
|
|
|
CONTACT:
Media:
Brad Miles, 646-513-3125
BMC
Communications
bmiles@bmccommunications.com
or
Investors:
Andrea
Rabney/Jamie Maarten, 212-600-1902
Argot Partners
andrea@argotpartners.com
jamie@argotpartners.com
Agenus (NASDAQ:AGEN)
Historical Stock Chart
From Mar 2024 to Apr 2024
Agenus (NASDAQ:AGEN)
Historical Stock Chart
From Apr 2023 to Apr 2024