Agenus Reports Third Quarter 2013 Financial Results
Agenus to host conference call beginning at 11 a.m. ET today
LEXINGTON, Mass. -- October 24, 2013
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 third quarter
ended September 30, 2013.
“Recently, we achieved important milestones in both QS-21 Stimulon^®1
adjuvant-containing programs as well as our Prophage Phase 2 newly diagnosed
brain cancer trial. We are gratified to have contributed to the clinical
success of the world’s most advanced malaria vaccine candidate with QS-21
Stimulon. We believe this important proof of efficacy could potentially lead
to a string of clinical successes in coming years,” said Garo H. Armen, Ph.D.,
chairman and CEO of Agenus. “Through our own efforts and those of our
partners, we remain committed to advancing our heat shock protein platform,
QS-21 Stimulon programs, and additional immunotherapy product candidates over
the next several years. In the near-term, we look forward to reporting Phase 2
data for HerpV, a therapeutic vaccine for the treatment of genital herpes, and
Phase 3 results from GSK’s MAGE-A3 non-small cell lung cancer trial.”
The company’s net loss attributable to common stockholders for the third
quarter of 2013 was $7.4 million, or $0.24 per share, basic and diluted,
compared to a net loss attributable to common stockholders of $5.9 million, or
$0.24 per share, basic and diluted, for the third quarter of 2012.
For the nine months ended September 30, 2013, the company reported a net loss
attributable to common stockholders of $27.4 million, or $0.99 per share,
basic and diluted, compared with a net loss attributable to common
stockholders of $6.5 million, or $0.28 per share, basic and diluted, for the
nine months ended September 30, 2012.
As a result of various corporate transactions, net loss for the nine months
ended September 30, 2013 increased compared to the net loss for the same
period in 2012 primarily due to $6.2 million of non-recurring non-cash charges
incurred during 2013 and one-time payments of $13.4 million received during
2012. 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 $30.2 million as of September 30, 2013.
Recent and Third Quarter 2013 Highlights
*New Phase 3 data for GSK’s RTS,S malaria vaccine candidate, which contains
Agenus’ QS-21 Stimulon adjuvant, were presented at a Multilateral
Initiative on Malaria Pan African Conference in Durban, South Africa. The
new data show that RTS,S helped protect young children and infants from
clinical malaria up to 18 months post vaccination.
*GSK initiated a Phase 3 study to evaluate the immunogenicity and safety of
the herpes zoster vaccine candidate HZ/su when co-administered with GSK's
seasonal influenza vaccine GSK2321138A in adults aged 50 years and older.
GSK’s HZ/su vaccine candidate for the prevention of shingles contains
Agenus’ QS-21 Stimulon adjuvant. GSK currently has 9 active Phase 3
studies underway for the HZ/su vaccine candidate.
*Agenus entered into a non-exclusive license agreement with VaxLogic for
the use of QS-21 Stimulon adjuvant in the development of select addiction,
allergy and respiratory disease vaccine candidates.
*Agenus completed a registered direct offering of $10 million. Agenus
issued an aggregate of 3,333,333 shares of its common stock at a price of
$3.00 per share along with 1,000,000 warrants to purchase its common stock
at an exercise price of $3.75 per share. Separately, Agenus received $11.4
million from the sale of our common stock in at-the-market offerings.
*A recent analysis from a Phase 2 trial in patients with newly diagnosed
glioblastoma multiforme (GBM) treated with Prophage Series G-100
(HSPPC-96) in combination with the current standard of care (radiation and
temozolomide) showed an almost 18 month median progression free survival,
which represents a 160% increase versus current standard of care alone.^2
Median overall survival (OS), the primary endpoint of the trial, is 23.3
months and remains durable in patients treated with HSPPC-96 versus the
standard of care alone, which is 14.6 months.^2 Based on these findings,
Agenus plans to hold an end of Phase 2 meeting with the US Food and Drug
Administration to discuss a Phase 3 trial that could potentially lead to
marketing approval of the HSPPC-96 vaccine as a treatment for patients
with newly diagnosed GBM.
*GSK’s Phase 3 MAGE-A3 cancer immunotherapeutic trial, which contains
Agenus’QS-21 Stimulon adjuvant, did not meet its first co-primary
endpoint. GSK will continue the study until the second co-primary endpoint
is assessed. This co-primary endpoint is based on predefined criterion
that was agreed upon by regulatory authorities. If further analysis shows
that the predefined gene signature subset data are successful, there is
the potential that a regulatory filing could be considered. GSK
anticipates that these data will be available in 2015.
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^3
*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^3
*Phase 3: GSK’s HZ/su for shingles^3
*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 in clinical development. QS-21Stimulon 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-21Stimulon-containing
programs advance, as well as royalties for 10 years after commercial launch,
with some exceptions.
Heat Shock Protein Platform (HSP): Recombinant Series HerpV
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,
one of the most clinically advanced HSV-2 therapeutic vaccine candidates in
development, 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 adjuvant.
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.
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 December 23, 2013. The replay
number is 416-915-1035 and the access code is 402191. The replay will also be
available on the company’s website approximately two hours after the live
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 June 30, 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. Stupp, R., et al., Radiotherapy plus concomitant and adjuvant temozolomide
for glioblastoma. N Engl J Med, 2005. 352(10): p. 987-96.
3. QS-21 Stimulon is a component of certain GSK adjuvant systems.
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 Nine months ended
September 30, September 30,
2013 2012 2013 2012
Revenue $ 736 $ 869 $ 2,653 $ 14,871
Cost of sales 80 217 529 369
Research and 3,893 2,606 9,764 8,194
General and 3,578 2,587 11,112 8,820
Operating (6,815 ) (4,541 ) (18,752 ) (2,512 )
Other expense, 504 1,188 5,543 3,373
Net loss (7,319 ) (5,729 ) (24,295 ) (5,885 )
convertible (51 ) (198 ) (3,109 ) (593 )
attributable $ (7,370 ) $ (5,927 ) $ (27,404 ) $ (6,478 )
attributable $ (0.24 ) $ (0.24 ) $ (0.99 ) $ (0.28 )
shares 30,345 24,529 27,774 23,275
Condensed Consolidated Balance Sheet Data
30, 2013 31, 2012
Cash and cash $ 30,205 $ 21,468
Total assets 37,670 29,093
stockholders' (2,877 ) (17,600 )
Media and Investor Contact:
Jonae R. Barnes, 617-818-2985
Investor Relations and
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