Agenus Reports Second Quarter 2013 Financial Results
Agenus to Host Conference Call Beginning at 11 a.m. ET Today
LEXINGTON, Mass., July 25, 2013 (GLOBE NEWSWIRE) -- Agenus Inc. (Nasdaq:AGEN),
a biotechnology company working to develop novel immunology based treatments
for cancers and infectious diseases, today announced its financial results and
business highlights for the second quarter ended June 30, 2013.
The company's net loss attributable to common stockholders for the second
quarter of 2013 was $11.2 million, or $0.40 per share, basic and diluted,
compared to a net loss attributable to common stockholders of $7.1 million, or
$0.31 per share, basic and diluted, for the second quarter of 2012.
For the six months ended June 30, 2013, the company reported a net loss
attributable to common stockholders of $20.0 million, or $0.76 per share,
basic and diluted, compared with a net loss attributable to common
stockholders of $551,000, or $0.02 per share, basic and diluted, for the six
months ended June 30, 2012.
As a result of various corporate transactions, net loss for the six months
ended June 30, 2013 increased compared to the net loss for the same period in
2012 primarily due to revenue generated in 2012 from one-time payments
received and to $6.2 million of non-recurring non-cash charges in 2013. In
the first quarter of 2013, the company's preferred stock restructuring, which
reduced the dividend requirements for its Series A-1 preferred securities,
resulted in a non-cash deemed dividend of $2.9 million.In the second quarter
of 2013, the company retired its outstanding $39 million 8.0% senior secured
convertible notes due August 2014 resulting in a non-cash loss on
extinguishment of debt of $3.3 million. In the first quarter of 2012, revenue
of $13.4 million was generated primarily due to one-time payments received
through an expanded agreement with GlaxoSmithKline (GSK) and through a license
of non-core technologies.Cash and cash equivalents were $13.4 million as of
June 30, 2013.
"Building upon the company's accomplishments during the first half of 2013, we
anticipate continued momentum during the second half of this year and into
2014," said Garo H. Armen, Ph.D., chairman and CEO of Agenus."The highlights
include Phase 2 results from our HerpV trial for genital herpes, updates to
our Prophage Series glioblastoma program, Phase 3 results from GSK's MAGE-A3
program in melanoma and non-small cell lung cancer, and long-term efficacy
data for GSK's RTS,S program for malaria. Positive data results in one or more
of these areas could represent a meaningful inflection point for the company."
*Agenus announced that enrollment began for a 222-patient, randomized Phase
2 study of Prophage Series G-200 (Heat Shock Protein Peptide Complex-96 or
HSPPC-96) vaccine in combination with bevacizumab (Avastin^®) to treat
recurrent glioblastoma multiforme (GBM) in adult patients.The study is
sponsored by a cooperative group of the National Cancer Institute (NCI)
called the Alliance for Clinical Trials in Oncology. This trial is the
largest brain tumor vaccine trial ever funded by the NCI and the largest
vaccine study ever conducted with Avastin.
*Agenus completed enrollment of the Phase 2 randomized, double-blind,
multicenter study for HerpV, a recombinant "off-the-shelf" therapeutic
vaccine candidate for the treatment of genital herpes in Herpes Simplex
Virus 2 (HSV-2) positive subjects.HerpV contains QS-21 Stimulon^®1
adjuvant ("QS-21 Stimulon"). This study is testing the biological efficacy
of the HerpV vaccine as measured by effect on genital viral shedding.The
Phase 2 data are anticipated during the fourth quarter of 2013.
*In a plenary session presentation, Orin Bloch, MD, of the Department of
Neurological Surgery, University of California San Francisco presented
positive preliminary data for Prophage Series G-100 in newly diagnosed GBM
at the ^ American Association of Neurological Surgeons (AANS) Annual
Scientific Meeting. Prophage Series G-100 plus the standard of care showed
a 146% increase in progression free survival (PFS) and a 60% increase in
overall survival (OS) as compared to historical controls using the
standard of care alone.
*Agenus retired its outstanding $39 million 8.0% senior secured convertible
notes due August 2014. These Notes were exchanged for $10 million in cash,
2.5 million shares of common stock and a twenty percent revenue interest
from QS-21 Stimulon partnered programs. In addition, the company entered
into debt transactions for $10 million in notes due April 2015 plus
500,000 warrants. Following these transactions, Agenus' total debt
obligation outstanding is $10 million, which was reduced from $39 million.
Between Agenus and its partners, a total of 23 vaccine programs are in
clinical development of which 21 contain QS-21 Stimulon. They include, but are
not limited to:
*Phase 3: GSK's RTS,S for malaria^2
*Phase 3: GSK's MAGE-A3 cancer immunotherapy for selected patients with
*Phase 3: GSK's MAGE-A3 cancer immunotherapy for selected patients with
resected non-small cell lung cancer^2
*Phase 3: GSK's HZ/su for shingles^2
*Phase 2:Janssen's ACC-001 for Alzheimer's disease
Agenus' pipeline programs include:
*Phase 2: HerpV (contains QS-21 Stimulon) for genital herpes
*Phase 2: Prophage Series G-100 for newly diagnosed GBM
*Phase 2: Prophage Series G-200 for recurrent GBM
Saponin Platform: QS-21 Stimulon^®Adjuvant
Agenus' QS-21 Stimulon adjuvant is one of the most widely tested vaccine
adjuvants under development. QS-21 Stimulon is designed to strengthen the
body's immune response to a vaccine's antigen, thus making it more effective.
QS-21 Stimulon is a key component in the development of investigational
preventive vaccine formulations across a wide variety of infectious diseases,
and appears to play an important role in several investigational therapeutic
vaccines intended to treat cancer and degenerative disorders. Licensees of
QS-21 Stimulon include GSK and Janssen Alzheimer Immunotherapy. Agenus is
generally entitled to receive milestone payments as QS-21 Stimulon-containing
programs advance, as well as royalties for 10 years after commercial launch,
with some exceptions.
Heat Shock Protein Platform (HSP): Recombinant Series
HerpV is a recombinant therapeutic vaccine candidate for the treatment of
genital herpes, which is caused by the herpes simplex virus-2 (HSV-2). HerpV
is the most clinically advanced HSV-2 therapeutic vaccine and is currently in
a Phase 2 randomized, double-blind, multicenter study. The Phase 2 data are
anticipated during the fourth quarter of 2013. The vaccine is based on Agenus'
HSP platform technology, and contains Agenus' proprietary QS-21 Stimulon
HerpV consists of recombinant human heat shock protein-70 complexed with 32
distinct 35-mer synthetic peptides from the HSV-2 proteome. This broad
spectrum of herpes antigens is intended to allow for more accurate immune
targeting and surveillance, reducing the likelihood of immune escape. Further,
the diversity of antigens in HerpV increases the chance of providing efficacy
for a wide segment of the patient population.
In a four-arm, Phase 1 study, 35 HSV-2 seropositive patients received HerpV
(designated in the study as AG-707 plus QS-21), AG-707, QS-21 alone, or
placebo. Patients received three treatments at two-week intervals. The vaccine
was generally well tolerated, with injection site pain as the most common
reported adverse event. All patients who received HerpV and were evaluable for
immune response showed a statistically significant CD4+ T cell response (100%;
7/7) to HSV-2 antigens as detected by IFNγ Elispot, and the majority of those
patients demonstrated a CD8+ T cell response (75%; 6/8). This study was
published in the scientific journal Vaccine.
Heat Shock Protein Platform (HSP): Prophage Series Cancer Vaccines
Derived from each individual's tumor, Prophage Series vaccines contain the
'antigenic fingerprint' of the patient's particular cancer and are designed to
reprogram the body's immune system to target only cancer cells bearing this
fingerprint. Prophage Series vaccines, based on our HSP platform technology,
are intended to leave healthy tissue unaffected and limit the debilitating
side effects typically associated with traditional cancer treatments such as
chemotherapy and radiation therapy.The Prophage Series vaccines are currently
being studied in both newly diagnosed and recurrent GBM.
Patient enrollment is underway for the large-scale, randomized Phase 2 trial
of Prophage Series G-200 in combination with Avastin in patients with
surgically resectable recurrent GBM. This trial is investigating the
combination of G-200 and Avastin in a three-arm randomized study of 222
patients with surgically resectable recurrent GBM.The study will compare
efficacy of G-200 given with Avastin either concomitantly or at progression,
versus Avastin alone.
For additional information please refer to www.clinicaltrials.gov or click on
the following link
In addition to the recurrent GBM study, a Phase 2 trial testing the Prophage
Series G-100 vaccine in patients with newly diagnosed GBM is ongoing. In this
trial, G-100 is being used with the standard of care, which includes Temodar^®
(Merck; temozolomide) and radiation. It is believed that the efficacy of G-100
could potentially be enhanced through this combination regimen.
Positive preliminary data presented at this year's AANS meeting showed a
median PFS of 17 months with Prophage G-100; these results compare favorably
to the PFS reported with the standard of care alone, which is 6.9 months.^3
Median OS, which is the primary endpoint for the trial, in patients treated
with G-100 is currently 23.3 months.For the standard of care alone, median OS
survival is 14.6 months.^3 The majority of enrolled patients in the trial
are still being followed and it is expected that PFS and OS will continue to
mature as more data are collected.
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 647-426-1845. 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 approximately two
hours after the call through midnight Eastern Time on August 25, 2013. The
replay number is 416-915-1035 and the access code is 102913. The replay will
also be available on the company's website approximately two hours after the
Agenus Inc. is a biotechnology company working to develop treatments for
cancers and infectious diseases. The company is focused on immunotherapeutic
products based on strong platform technologies with multiple product
candidates advancing through the clinic, including several product candidates
that have advanced into late-stage clinical trials through corporate partners.
For more information, please visit www.agenusbio.com.
This earnings release contains forward-looking statements, including
statements regarding development and clinical trial activities, data read-outs
and timelines of the company and its licensees and collaborators; potential
benefit of product candidates in development, and potential revenue streams
from our partnering and licensing arrangements. 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, decisions by regulatory authorities, physicians, patients, and our
existing and potential licensees and collaborators; the possibility that
clinical trial results will not be favorable; the inability to secure
favorable partnering arrangements; the ability to raise capital; and the
factors described under the Risk Factors section of our Annual Report on Form
10-Q filed for the period ended March 31, 2013, and other reports 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 document, and
Agenus undertakes no obligation to update or revise the statements. All
forward-looking statements are expressly qualified in their entirety by this
cautionary statement. Agenus' business is subject to substantial risks and
uncertainties, including those identified above. When evaluating Agenus'
business and securities, investors should give careful consideration to these
risks and uncertainties.
1. QS-21 Stimulon^® adjuvant and the related agreements, and HerpV are assets
of Antigenics Inc., a wholly owned subsidiary of Agenus Inc.
2. QS-21 Stimulon is a component of certain GSK adjuvant systems.
3. Stupp, R., et al., Radiotherapy plus concomitant and adjuvant temozolomide
for glioblastoma. N Engl J Med, 2005. 352(10): p. 987-96.
Stimulon is a registered trademark of Agenus Inc. and its subsidiaries.
Avastin is a registered trademark of Genentech.
Summary Consolidated Financial Information
Condensed Consolidated Statements of Operations Data
(in thousands, except per share data)
Three months ended June 30, Six months ended June 30,
2013 2012 2013 2012
Revenue $807 $627 $1,917 $14,002
Cost of sales 177 128 449 152
Research and development 3,317 2,911 5,871 5,588
General and 4,642 3,359 7,534 6,233
Operating (loss) income (7,329) (5,771) (11,937) 2,029
Other expense, net 3,813 1,152 5,040 2,185
Net loss (11,142) (6,923) (16,977) (156)
Dividends on Series A
convertible preferred (51) (198) (3,058) (395)
Net loss attributable to $(11,193) $(7,121) $(20,035) $(551)
Per common share data,
basic and diluted:
Net loss attributable to $(0.40) $(0.31) $(0.76) $(0.02)
Weighted average number
of common shares 27,846 22,947 26,466 22,641
outstanding, basic and
Condensed Consolidated Balance Sheet Data
June 30, 2013 December 31,
Cash and cash $13,445 $21,468
Total assets 21,371 29,093
Total stockholders' (17,263) (17,600)
CONTACT: Media and Investor Contact:
Jonae R. Barnes
Investor Relations and
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