Agenus Reports First Quarter 2013 Financial Results
Agenus to Host Conference Call Beginning at 11 a.m. ET Today
LEXINGTON, Mass., April 24, 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 first quarter ended March
The company reported a net loss attributable to common stockholders of $8.8
million, or $0.35 per share, basic and diluted, for the first quarter of 2013,
compared with net income attributable to common stockholders in the first
quarter of 2012 of $6.6 million, or $0.29 per share, basic and diluted.
Cash used in operating activities for the first quarter ended March 31, 2013
was $3.9 million compared to cash provided by operating activities of $11.3
million for the same period in 2012. Cash and cash equivalents were $17.2
million as of March 31, 2013.
Net loss for the first quarter of 2013 compared to net income in 2012 is a
result of various corporate transactions. 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 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.
"After the close of the quarter, we successfully restructured and
significantly reduced our debt," said Garo H. Armen, Ph.D., chairman and CEO
of Agenus."This year we expect Phase 3 data from GSK's MAGE-A3 vaccine
programs, Phase 2 data for HerpV to treat genital herpes, and Phase 2 data for
Prophage Series to treat newly diagnosed and recurrent glioma.Positive
results from these studies could represent breakthrough advances in research
related to therapeutic vaccines."
*Agenus has completed screening for 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
*In a plenary session presentation, Orin Bloch, MD, of the Department of
Neurological Surgery, University of California San Francisco (UCSF) will
present an abstract that reports on outcomes with HSPPC-96 vaccination in
patients with newly diagnosed glioma at the 81^st American Association
of Neurological Surgeons (AANS) Annual Scientific Meeting in New Orleans,
Louisiana on May 1st.
*In early April, Agenus retired its outstanding $39 million 8.00% senior
secured convertible notes due August 2014. These Notes were exchanged for
$10 million in cash, 2,500,000 shares of common stock and a twenty percent
revenue interest from QS-21 Stimulon partnered programs. In addition, the
company entered into two separate $5 million debt transactions for $10
million total in notes plus 500,000 share warrants. Following these
transactions, Agenus' total debt obligation outstanding is $10 million,
down from $39 million.
*Agenus reduced the dividend rate on its convertible preferred stock by
exchanging Series A for Series A-1, thereby reducing the annual rate from
2.5% to 0.6325%.In exchange for the reduced dividend rate, Agenus issued
the preferred stockholder 666,666 shares of common stock, $0.01 par value.
Between Agenus and its partners, a total of 19 vaccine programs are in
clinical development of which 17 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 glioma
*Phase 2: Prophage Series G-200 for recurrent glioma
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 G Series vaccines are
currently being studied in two different settings of glioma: newly diagnosed
and recurrent disease.
Patient enrollment is expected to begin during the second quarter of 2013 for
the large-scale, randomized Phase 2 trial of Prophage Series G-200 in
combination with Avastin^® in patients with surgically resectable recurrent
GBM. The study, which is the largest cancer vaccine study ever funded by the
NCI in brain tumors, is sponsored by the Alliance for Clinical Trials in
Oncology, an NCI cooperative group. This trial will investigate 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, in the therapy of surgically resectable recurrent GBM.
For additional information please refer to www.clinicaltrials.gov or click on
the following link
In addition to the recurrent GBM study with G-200, a Phase 2 trial testing the
Prophage Series G-100 vaccine in patients with newly diagnosed glioma 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.Initial data from this study will be presented in a plenary session
at the AANS meeting on May 1, 2013.
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 April 25, 2013. The
replay number is 416-915-1035 and the access code is 735470. 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 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-K filed for the period ended December
31, 2012 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.
Stimulon is a registered trademark of Agenus Inc. and its subsidiaries.
Summary Consolidated Financial Information
Condensed Consolidated Statements of Operations Data
(in thousands, except per share data)
Three months ended March 31,
Revenue $1,109 $13,375
Cost of sales 273 24
Research and development 2,554 2,677
General and administrative 2,891 2,873
Operating (loss) income (4,609) 7,801
Other expense, net (1,226) (1,033)
Net (loss) income (5,835) 6,768
Dividends on Series A convertible preferred (3,007) (198)
Net (loss) income attributable to common $(8,842) $6,570
Per common share data:
Net (loss) income attributable to common $(0.35) $0.29
Net(loss) income attributable to common $(0.35) $0.29
Weighted average number of common shares 25,072 22,336
Weighted average number of common shares 25,072 22,338
Condensed Consolidated Balance Sheet Data
March 31, 2013 December 31, 2012
Cash and cash equivalents $17,214 $21,468
Total assets 25,133 29,093
Total stockholders' deficit (22,684) (17,600)
CONTACT: Media and Investors:
Jonae R. Barnes
Investor Relations &
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