Corporate Update Conference Call at 11
am ET Today
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 ResultsThe 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
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