Full Press Release Details
Reports Second Quarter and Six Month Financial Results
Call Wednesday, August 6 at 9:00 a.m. Eastern Time
NEEDHAM, Mass.--(BUSINESS WIRE)--AVANT Immunotherapeutics, Inc. (NASDAQ:
AVAN) today reported financial results for the second quarter and
six-month period ended June 30, 2008. AVANT reported a net loss of $10.3
million, or $0.67 per share, for the second quarter of 2008 compared to
a net loss of $2.8 million, or $0.33 per share, for the second quarter
of 2007. For the six months ended June 30, 2008, AVANT reported a net
loss of $32.4 million, or $2.56 per share, compared to a net loss of
$6.8 million, or $0.82 per share, for the six months ended June 30,
2007. The 2007 financial results reflect the activities of Celldex only.
As discussed in further detail later in this release, the increase in
net loss between the three-month periods was primarily due to increased
operating expenses as a result of the merger of AVANT and Celldex,
offset partially by increased revenues and investment and other income.
The increase in net loss between the six-month periods was primarily due
to non-cash charge of $17.2 million, or $1.35 per share, relating to
purchased in-process research and development of $14.8 million and
stock-based compensation expense of $2.4 million. At June 30, 2008,
AVANT reported cash and cash equivalents of $52.4 million. This amount
includes upfront payments totaling $50 million from AVANT's license and
development agreement with Pfizer for CDX-110, including a $10 million
equity investment by Pfizer. AVANT anticipates receiving a $10 million
milestone payment from Paul Royalty Fund upon GlaxoSmithKline's U.S.
launch of Rotarix , which we expect to receive in the second half of
"During the quarter, AVANT completed one of the largest partnership
agreements in cancer immunotherapy when we entered into an agreement
with Pfizer for our novel therapeutic vaccine candidate-CDX-110," said
Anthony S. Marucci, AVANT's interim President and Chief Executive
Officer. "We continued to add to the rich data package for CDX-110 with
the presentation of positive Phase 2 survival data in patients with
glioblastoma multiforme at ASCO. In addition, we augmented our vaccine
platform, entering into a collaboration with 3M to access key toll-like
receptor (TLR) agonists for clinical study with our proprietary Antigen
Presenting Cell Targeting Technology . We are now able to implement a
comprehensive immunotherapy strategy which we believe will open new
doors to treatments for cancer and infectious disease."
Key 2008 events recently announced:
Entered into an exclusive worldwide licensing agreement with Pfizer
for our therapeutic cancer vaccine candidate, CDX-110, which is in
Phase 2/3 development for the treatment of glioblastoma multiforme
(GBM). This agreement also gives Pfizer exclusive rights to the
development of EGFRvIII vaccines in other potential indications. Under
the licensing and development agreement, Pfizer made an upfront
payment to AVANT of $40 million and made a $10 million equity
investment in AVANT, and thereafter Pfizer will fund all development
costs for these programs. AVANT is also eligible to receive milestone
payments exceeding $390 million for the successful development and
commercialization of CDX-110 and additional EGFRvIII vaccine products,
as well as double-digit royalties on any product sales.
Presented updated data from the Phase 2 ACTIVATE trial (n=21) and the
continuation study, ACT II (n=23) of CDX-110 in patients with newly
diagnosed EGFRvIII-positive glioblastoma multiforme (GBM) at ASCO.
CDX-110 was generally well-tolerated with primary toxicity reported as
local injection site reactions.
In the ACTIVATE study, median survival time was 26 months (95% CI:
21.6, infinity) and median time-to-progression (TTP) was 14.2 months.
No significant adverse events were seen in this study. Median survival
in a historical matched cohort was 15.2 months (17/17) (95% CI: 13.9,
20.5) (p=0.0001) with median time to progression of 7.13 months
Preliminary results from the ACT II study currently estimate median
overall survival to be 33.1 months, although the median has not yet
been reached. The survival of a matched historical control group was
14.3 months (95% CI: 13.0, 16.2) and a subgroup treated with
temozolomide (TMZ) of 15.2 months (95% CI: 13.9, 20.5 p=0.0078).
Overall TTP was 16.6 months (95% CI: 10.8, infinity) compared with 6.4
months for the historical control group (95% CI: 5.0, 14.1).
Announced multi-year clinical research collaborations with 3M to
access their proprietary Immune Response Modifier Resiquimod (and
additional Toll-Like Receptor 7/8 agonists (TLR)) for clinical study
with the Company's proprietary Antigen Presenting Cell (APC) Targeting
Technology , for use as vaccine adjuvants.
Announced that the Division of Microbiology and Infectious Diseases of
the National Institute of Allergy and Infectious Diseases (NIAID), an
institute of the National Institutes of Health (NIH), has initiated a
Phase 1 safety study of AVANT's investigational single-dose, oral
vaccine designed to offer combined protection against both
enterotoxigenic Escherichia coli (ETEC) and cholera. ETEC
infection is a major cause of travelers' diarrhea.
Reported results that the double-blind, placebo-controlled
multi-center Phase 2 clinical trial of Ty800 met all primary
endpoints. Importantly, immunogenic response was dose-dependent.
Positive immune response or seroconversion (prospectively defined as a
4-fold increase in anti-LPS titers over pre-dose level) rates were 65%
(36/55) and 80% (44/55) in the low and high dose groups, respectively,
and was significantly (p<0.001) higher than placebo.
Announced that GlaxoSmithKline (Glaxo) received approval from the U.S.
Food and Drug Administration (FDA) for Glaxo's Rotarix product for
the prevention of rotavirus gastroenteritis in infants. AVANT licensed
a rotavirus strain to Glaxo that was used in the development of
Rotarix . FDA approval triggered a $1.5 million milestone payment from
Glaxo, $750,000 of which AVANT retained.
Further Financial Highlights
The net loss for the second quarter of 2008 showed an increase of $7.5
million compared to the net loss for the same period in 2007. The
increase in net loss reflected an increase in operating expenses which
includes the combined operations of AVANT and Celldex post-merger,
offset in part by an increase in revenues. The increase in net loss also
reflected an increase in investment and other income. Research and
development (R&D) expenses in the second quarter of 2008 increased $5.2