CORRECTING and REPLACING AVANT Reports Second Quarter and Six Month Financial Results
2008-08-06 07:46:00
CORRECTING and REPLACING AVANT Reports Second Quarter and Six Month Financial Results
Conference Call Wednesday, August 6 at 9:00 a.m. Eastern Time
NEEDHAM, Mass.–(EMWNews)–Please replace the release with the following corrected version due to
multiple revisions.
AVANT REPORTS SECOND QUARTER AND SIX MONTH FINANCIAL RESULTS
Conference Call Wednesday, August 6 at 9:00 a.m. Eastern Time
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 2008.
“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
(p=0.0001).1
-
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
million compared to R&D expenses in 2007 due primarily to sublicense
fees payable and increased clinical trials costs for CDX-110 and
CD-1307. General and administrative (G&A) expenses increased $3.6
million due primarily to accrued severance costs and increased
professional services expenses.
The six-month results for 2008 reflect an increase in net loss compared
to the same period in 2007. The increase in net loss reflected an
increase in operating expenses due primarily to the combined operating
expenses of the two companies from March 8 to June 30, 2008, including a
non-cash charge of $14.8 million for purchased in-process R&D and
non-cash charges of $1.1 million and $1.3 million for stock-based
compensation expense in R&D expense and G&A expense, respectively. The
increase in operating expenses also resulted from higher general and
administrative expenses, which is primarily due to increases in
personnel-related expenses and professional services costs for the
combined companies. The increase in net loss also reflected a decrease
in investment and other income.
Revenues for the first six months of 2008 increased compared with
revenues for the first six months of 2007. The increase in product
development and licensing revenue in 2008 primarily reflects recognition
of $492,020 in Pfizer deferred revenue related to CDX-110 in the second
quarter of 2008. The decrease in contracts and grants revenue in 2008
compared to 2007 primarily reflects reduced levels of vaccine
development work billable to Rockefeller University between periods. In
the first six months of 2008, AVANT also recognized $837,122 in product
royalty revenue related to royalty expense payable to CCH.
Important Information Related to AVANT’s
Financial Results
On March 7, 2008, AVANT completed the merger of a wholly-owned
subsidiary of AVANT with Celldex Therapeutics, Inc. (Celldex). The
merger has created a NASDAQ-listed, fully-integrated and diversified
biopharmaceutical company with a deep pipeline of product candidates
addressing indications in oncology, infectious and inflammatory
diseases. In connection with the merger, AVANT’s
board of directors approved a 1-for-12 reverse stock split of AVANT’s
common stock, which became effective on March 7, 2008. As of June 30,
2008, AVANT had approximately 15.8 million shares outstanding.
The merger was accounted for using the purchase method of accounting and
was treated as an acquisition by Celldex of AVANT with Celldex being
considered the accounting acquirer even though AVANT was the issuer of
common stock and surviving legal entity in the transaction. Because
Celldex was determined to be the acquirer for accounting purposes, the
historical financial statements of Celldex became the historical
financial statements of the Company. Accordingly, the financial
statements of the Company prior to the merger reflect the financial
position, results of operations and cash flows of Celldex only.
Following the merger, the financial statements of the current three- and
six-month periods reflect the financial position, results of operation
and cash flows of Celldex for the three- and six-month periods ended
June 30, 2008 combined with the results of operations of AVANT beginning
March 8, 2008. Accordingly, the attached financial information reflects
the financial condition, results of operations and liquidity of the
Company at June 30, 2008 and historically of Celldex on a stand-alone
basis for all periods prior to March 8, 2008. The financial condition,
results of operations and liquidity of the Company as of June 30, 2008
and 2007 may not be indicative of the Company’s
future performance or reflect what the Company’s
financial conditions, results of operations and liquidity would have
been had the merger been consummated as of January 1 of each respective
year or had the Company operated as a separate, stand-alone entity
during the periods presented.
Webcast and Conference Call
AVANT will host a conference call and live audio webcast at 9:00 AM ET
on Wednesday, August 6, 2008 to discuss AVANT’s
second quarter and six month 2008 financial results. To access the
conference call, dial 888-713-4199 (within the U.S.), or 617-213-4861
(if calling from outside the U.S.). The passcode for participants is
98796339. An audio replay will be available approximately two hours
after the call for approximately one week and can be accessed by dialing
888-286-8010 (within the U.S.), or 617-801-6888 (if calling from outside
the U.S.). The passcode I.D. number is 22696598. The replay will also be
broadcast via the Company’s website, www.avantimmune.com,
after the live call. Additionally, a copy of this press release is
available by contacting Investor Relations at 781-433-0771.
About AVANT Immunotherapeutics, Inc.
AVANT Immunotherapeutics, Inc. is a NASDAQ-listed company discovering
and developing innovative vaccines and targeted immunotherapeutics for
the treatment of cancer, infectious and inflammatory diseases. AVANT
focuses on the use of tumor-specific targets and human monoclonal
antibodies (mAbs) to precisely deliver therapeutic agents through its
novel “targeted immunization”
approach. In addition, AVANT is also exploiting its access to
proprietary human antibody technology for development of therapeutics
monoclonal antibodies (mAbs). AVANT’s deep
product pipeline consists of products in varying stages of development,
with its lead candidate, CDX-110, partnered with Pfizer, Inc., currently
undergoing evaluation in a Phase 2/3 clinical trial in newly diagnosed
glioblastoma multiforme, one of the most aggressive forms of brain
cancer. AVANT also has five product candidates in its development
pipeline including:
-
CDX-1307, a product based on its proprietary APC Targeting Technology™,
which is in two Phase 1 clinical trials for patients with advanced
pancreatic, bladder, breast and colon cancer;
-
TP10, a complement inhibitor, in development for transplantation and
other indications; and
-
Three candidates based on its oral, rapidly-protecting, single-dose
and temperature-stable vaccine technology, including combination
vaccines for travelers, the military and global health needs.
AVANT licensed a rotavirus strain to GlaxoSmithKline that was used in
the development of Rotarix®
for the prevention of rotavirus infection. In addition, AVANT has two
human food safety vaccines for reducing salmonella infection in chickens
and eggs which have been commercialized. Additional information on AVANT
Immunotherapeutics, Inc. can be obtained through its site on the World
Wide Web: http://www.avantimmune.com.
Safe Harbor Statement Under the Private Securities Litigation
Reform Act of 1995: This release includes forward-looking statements
that are subject to a variety of risks and uncertainties and reflect
AVANT’s current views with respect to future
events and financial performance. There are a number of important
factors that could cause the actual results to differ materially from
those expressed in any forward-looking statement made by AVANT. These
factors include, but are not limited to: (1) the successful integration
of the businesses, multiple technologies and programs of AVANT and
Celldex; (2) the ability to adopt AVANT’s APC
Targeting TechnologyTM to develop
new, safe and effective vaccines against oncology and infectious disease
indications; (3) the ability to adapt AVANT’s
vectoring systems to develop new, safe and effective orally administered
vaccines against disease causing agents; (4) the ability to successfully
complete product research and further development, including animal,
preclinical and clinical studies, and commercialization of CDX-110,
CDX-1307, CholeraGarde® (Peru-15), Ty800,
ETEC E. coli vaccine, and other products and AVANT’s
expectations regarding market growth; (5) the cost, timing, scope and
results of ongoing safety and efficacy trials of CDX-110, CDX-1307,
CholeraGarde® (Peru-15), Ty800, ETEC E. coli
vaccine and other preclinical and clinical testing; (6) the ability to
negotiate strategic partnerships or other disposition transactions for
AVANT’s cardiovascular programs, including
TP10 and CETi; (7) the ability of AVANT to manage multiple clinical
trials for a variety of product candidates; (8) the volume and
profitability of product sales of Megan®Vac
1, Megan®Egg
and other future products; (9) GlaxoSmithKline’s,
or Glaxo’s, process of obtaining regulatory
approval for the sale of Rotarix®
in major commercial markets, as well as the timing and success of
worldwide commercialization of Rotarix®
by Glaxo, which is not within our control; (10) Glaxo’s
strategy and business plans to launch and supply Rotarix®
worldwide, including in the U.S. and other major markets, which is not
within our control, and its payment of royalties to AVANT; (11) Pfizer’s
and our strategy and business plans concerning the continued development
and commercialization of CDX-110; (12) AVANT’s
expectations regarding its technological capabilities and expanding its
focus to broader markets for vaccines; (13) changes in existing and
potential relationships with corporate collaborators; (14) the
availability, cost, delivery and quality of clinical and commercial
grade materials produced at AVANT’s own
manufacturing facility or supplied by contract manufacturers and
partners; (15) the timing, cost and uncertainty of obtaining regulatory
approvals; (16) AVANT’s ability to develop
and commercialize products before competitors that are superior to the
alternatives developed by such competitors; (17) AVANT’s
ability to retain certain members of management;(18) AVANT’s
expectations regarding research and development expenses and general and
administrative expenses; (19) AVANT’s
expectations regarding cash balances, capital requirements, anticipated
royalty payments (including those from Paul Royalty Fund), revenues and
expenses, including infrastructure expenses; (20) the ability to obtain
substantial additional funding; (21) AVANT’s
belief regarding the validity of our patents and potential litigation;
and (22) certain other factors that might cause AVANT’s
actual results to differ materially from those in the forward-looking
statements including those set forth under the headings “Business,”
“Risk Factors” and
Management’s Discussion and Analysis of
Financial Condition and Results of Operations”
in each of AVANT’s Annual Report on Form
10-K, its current Reports on Form 8-K, as well as those described in
AVANT’s other press releases and filings with
the Securities and Exchange Commission, from time to time. You
should carefully review all of these factors, and you should be aware
that there may be other factors that could cause these differences. These
forward-looking statements were based on information, plans and
estimates at the date of this press release, and AVANT does not promise
to update any forward-looking statements to reflect changes in
underlying assumptions or factors, new information, future events or
other changes.
1 Heimberger, A., et al. Epidermal Growth
Factor Receptor VIII Peptide Vaccination Is Efficacious Against
Established Intracerebral Tumors. Clin Cancer Res Vol. 9,
pp4247-4254, September 15, 2003.
AVANT IMMUNOTHERAPEUTICS, INC. |
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CONSOLIDATED STATEMENTS |
Quarter |
Six Months |
|||||||||||||||
OF OPERATIONS DATA |
|
Ended June 30, |
|
Ended June 30, |
|||||||||||||
2008 |
2007 |
2008 |
2007 |
||||||||||||||
(Unaudited) |
(Unaudited) |
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REVENUE |
|||||||||||||||||
Product Development and |
|||||||||||||||||
Licensing Agreements |
$ |
845,529 |
$ |
116,539 |
$ |
965,393 |
$ |
233,078 |
|||||||||
Contracts and Grants |
278,960 |
492,645 |
306,494 |
520,146 |
|||||||||||||
Product Royalties |
|
|
837,122 |
|
|
|
– |
|
|
|
837,122 |
|
|
|
– |
|
|
|
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Total Revenue |
|
|
1,961,611 |
|
|
|
609,184 |
|
|
|
2,109,009 |
|
|
|
753,224 |
|
|
|
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OPERATING EXPENSE |
|||||||||||||||||
Research and Development |
7,611,666 |
2,369,824 |
12,117,294 |
5,159,189 |
|||||||||||||
General and Administrative |
4,605,482 |
1,049,423 |
7,619,386 |
2,578,000 |
|||||||||||||
Charge for Purchased In-Process |
|||||||||||||||||
Research and Development |
– |
– |
14,755,908 |
– |
|||||||||||||
Amortization of Acquired Intangible Assets |
|
|
104,164 |
|
|
|
29,233 |
|
|
|
153,058 |
|
|
|
58,466 |
|
|
|
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Total Operating Expense |
|
|
12,321,312 |
|
|
|
3,448,480 |
|
|
|
34,645,646 |
|
|
|
7,795,655 |
|
|
|
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Operating Loss |
(10,359,701 |
) |
(2,839,296 |
) |
(32,536,637 |
) |
(7,042,431 |
) |
|||||||||
|
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Investment Income, Net |
|
|
99,191 |
|
|
|
84,159 |
|
|
|
145,445 |
|
|
|
254,891 |
|
|
|
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Net Loss |
|
$ |
(10,260,510 |
) |
|
$ |
(2,755,137 |
) |
|
$ |
(32,391,192 |
) |
|
$ |
(6,787,540 |
) |
|
|
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Basic and Diluted Net Loss per |
|||||||||||||||||
|
Common Share |
|
$ |
(0.67 |
) |
|
$ |
(0.33 |
) |
|
$ |
(2.56 |
) |
|
$ |
(0.82 |
) |
Weighted Average Common |
|||||||||||||||||
|
Shares Outstanding |
|
|
15,227,475 |
|
|
|
8,309,420 |
|
|
|
12,677,455 |
|
|
|
8,309,420 |
|
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CONDENSED CONSOLIDATED |
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BALANCE SHEETS |
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|
June 30, |
|
December 31, |
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2008 |
2007 |
||||||||||||||||
(Unaudited) |
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ASSETS |
|||||||||||||||||
Cash and Cash Equivalents |
$ |
52,379,836 |
$ |
4,909,530 |
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Other Current Assets |
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