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UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 8-K
PURSUANT TO SECTION 13 OR 15(d)
OF THE SECURITIES EXCHANGE ACT OF 1934
Date of Report (Date of earliest event reported): October 21, 2004
Commission file number 0-15006
AVANT Immunotherapeutics, Inc.
(Exact name of registrant as specified in its charter)
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Delaware 13-3191702
(State or other jurisdiction of (I.R.S. Employer
incorporation or organization) Identification No.)
119 Fourth Avenue
Needham, Massachusetts 02494
(Address of principal executive offices, including zip code)
(781) 433-0771
(Registrant's telephone number, including area code)
(Former name, if changed since last report)
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Check the appropriate box below if the Form 8-K filing is intended to
simultaneously satisfy the filing obligation of the registrant under any of the
following provisions:
[] Written communications pursuant to Rule 425 under the Securities Act
(17 CFR 230.425)
[] Soliciting material pursuant to Rule 14a-12 under the Exchange Act
(17 CFR 240.14a-12)
[] Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange
Act (17 CFR 240.14d-2(b))
[] Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange
Act (17 CFR 240.13e-4(c))
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Item 2.02. Results of Operations and Financial Condition.
On Ocotber 21, 2004, AVANT Immunotherapeutics, Inc. issued a press release
announcing its financial results for the third quarter of 2004. The full text of
the press release is furnished as Exhibit 99.1 hereto is incorporated by
reference herein.
Item 9.01. Financial Statements and Exhibits.
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99.1 Press Release of AVANT Immunotherapeutics, Inc. dated October 21,
2004.
[Remainder of page left blank intentionally]
SIGNATURE
Pursuant to the requirements of the Securities Exchange Act of 1934, as amended,
the registrant has duly caused this report to be filed on its behalf by the
undersigned hereunto duly authorized.
AVANT Immunotherapeutics, Inc.
Dated: October 21, 2004 By: /s/ Avery W. Catlin
---------------------------------------------
Avery W. Catlin
Senior Vice President and
Chief Financial Officer
Exhibit Index
99.1 Press Release of AVANT Immunotherapeutics, Inc. dated October 21, 2004.
AVANT Immunotherapeutics Reports Third Quarter Fiscal 2004 Financial Results
NEEDHAM, Mass.--(BUSINESS WIRE)--Oct. 21, 2004--AVANT
Immunotherapeutics, Inc. (Nasdaq: AVAN) today reported a net loss of
$3.7 million, or $.05 per share, for the third quarter of 2004
compared with $2.1 million, or $.03 per share, for the third quarter
of 2003. For the nine months ended September 30, 2004, the net loss
was $9.5 million, or $.13 per share, compared with $8.7 million, or
$.14 per share, for the first nine months of 2003. The increase in net
loss between periods primarily reflects increased research and
development expenses due to an increase in clinical trial costs
associated with AVANT's ongoing TP10 Phase IIb study in women
undergoing cardiac bypass surgery and TP10 contract manufacturing
costs incurred for process development and scale-up work in
preparation for the production of Phase III clinical materials in
2005. At September 30, 2004, AVANT reported cash and cash equivalents
of $35.2 million.
Revenues for the third quarter of 2004 were $527,600 compared with
revenues of $2 million for the third quarter of the prior year. The
decrease reflects a reduction in government contract revenue in 2004
compared to 2003 and the recognition of a $1 million milestone payment
from GlaxoSmithKline in the third quarter of 2003 upon initiation of
Phase III trials of the Rotarix(R) rotavirus vaccine. Revenues were
$4.5 million for the nine months ended September 30, 2004, compared
with revenues of $3.8 million for the first nine months of 2003. The
increase in revenues results primarily from the recognition of $1
million in revenue from DynPort Vaccine Company LLC ("DVC") for rPA
clinical materials and an upfront license fee of $1 million from
AdProTech, Ltd. in the first quarter of 2004, offset by the
recognition of a GlaxoSmithKline milestone received in 2003. Operating
expense increased $1,603,100 in the first nine months of 2004 compared
to 2003, primarily as a result of clinical trials costs and contract
manufacturing costs incurred on the company's TP10 complement
inhibitor program. We had higher investment income in 2004 reflecting
higher average cash balances between periods.
Una S. Ryan, Ph.D., AVANT's President and Chief Executive Officer,
said, "These financial results were consistent with our expectations
and we remain on track to meet our forecasts for the full year. We are
also pleased with the progress of our product development programs
during the first nine months of 2004."
During the third quarter, AVANT had several noteworthy
accomplishments which further prepare us to become a commercial
company including:
-- We were delighted to announce that our partner GlaxoSmithKline
(GSK) had received marketing approval from the Mexican Board
of Health for Rotarix(R), our two-dose oral vaccine against
rotavirus. This is the first commercial approval for this
important healthcare product, and we expect to hear from Glaxo
regarding additional approvals over the coming year.
-- The Defense Appropriations Bill for Fiscal Year 2005, passed
by Congress in July, commits $2.8 million to the continued
development of our oral combination vaccine against anthrax
and plague.
-- Construction is nearing completion at our pilot manufacturing
facility in Fall River. The Opening Ceremony with
Massachusetts Governor Romney speaking is scheduled for
November 5th. The facility will produce our anthrax-plague
vaccine and implement our VitriLife(R) technology, offering
AVANT new opportunities for corporate partnering.
Rotarix(R) Vaccine
The July approval for Rotarix(R) in Mexico is just a first step.
GSK expects to achieve a series of rolling launches throughout Latin
America and Southeast Asia - two areas of greatest need - over the
coming year, followed by Europe and other markets. According to
published reports, marketing applications are pending in 12 additional
Latin American countries.
Rotarix is an extremely important product from a global health
needs perspective. Rotavirus infection is the leading cause of severe
diarrhea and vomiting in infants and young children and globally is
responsible for about 440,000 deaths per year - nearly a child a
minute. The majority of these deaths occur in the Indian subcontinent,
sub-Saharan Africa and South America. GSK has stated that the
potential annual market for a successful rotavirus vaccine
approximates $1.8 billion dollars - with about half that market
potential outside the United States.
GSK has not yet unveiled U.S. launch plans for Rotarix(R). We
would expect that based on the extensive clinical data that GSK is
accruing worldwide on Rotarix(R), they will ultimately seek to enter
the U.S. market with a vaccine which we believe would be highly
competitive and whose safety and efficacy is well proven through
studies in more than 70,000 infants.
TP10 for Cardiac Surgery
Enrollment of the Phase IIb study in women undergoing cardiac
bypass surgery at approximately 30 clinical sites has progressed
slower than we anticipated. We now expect to complete enrollment as
soon as possible and report out results in the first half of 2005. We
are working closely with our manufacturing partner, Lonza Biologics
plc, to complete process development and scale-up efforts in
preparation for the production of Phase III clinical materials and the
start of that registration-directed trial by year-end 2005.
In September, Circulation published results of the TP10
double-blind, placebo-controlled Phase II study in 564 adult patients
undergoing cardiac surgery on cardiopulmonary bypass (CPB), which as
previously disclosed, showed that TP10 significantly decreased the
incidence of mortality and acute myocardial infarction (heart attack)
in male patients. Also as previously reported, the study did not show
a similar benefit in female patients. Since treatment for both genders
is desirable, the goals of the ongoing Phase IIb female study are to
clarify the effect that TP10 hs in women undergoing cardiac surgery,
as well as augment the safety data for the female patient population.
CETP Vaccine for Cholesterol Management
We continue to evaluate a number of new adjuvants and delivery
technologies for our CETP vaccine in animal models and expect to
choose the approach eliciting the most robust antibody response by
year-end. We are strongly committed to this program and it is our plan
to have a CETP vaccine back into the clinic towards the end of 2005.
Webcast and Conference Call
Dr. Ryan and Mr. Catlin will host a conference call at 11:00 AM
EDT on Thursday, October 21, 2004 to discuss AVANT's Third Quarter
2004 financial results. To access the conference call, dial
800-329-9097 (within the United States), or 617-614-4929 (if calling
from outside the U.S.). The passcode for participants is 63247445. 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.# is 60250729.
A live webcast of the conference call, together with this press
release, can be accessed through the company's web site
www.avantimmune.com in the Investor Information section. In order to
access the webcast, your PC must have a sound card, speakers and
Windows Media Player software. It is recommended that you configure
your PC in advance of the webcast as the software download and
installation can take several minutes. In addition, the call and
webcast will be archived and can be accessed through the same link.
Additionally, a copy of this press release is available by contacting
Investor Relations at (781) 433-0771.
AVANT Immunotherapeutics, Inc. discovers, develops and sells
innovative vaccines and therapeutics that harness the human immune
system to prevent and treat disease. The company has developed a
broad, well-staged pipeline of vaccines and therapeutics for large,
high-value, under-served markets. These include an oral human
rotavirus vaccine, which gained its first marketing approval in Mexico
in July 2004. Six of AVANT's products are in clinical development,
including a treatment to reduce complement-mediated tissue damage
associated with cardiac by-pass surgery, and a novel vaccine for
cholesterol management. AVANT has also assembled a technology platform
that enables the creation of rapid-protecting, single-dose, oral
vaccines that remain stable without refrigeration. The company is
developing applications of this vaccine technology in four areas:
biodefense, travelers' vaccines, global health needs, and human food
safety. AVANT's goal is to demonstrate proof-of-concept for its
products before leveraging further development through both
traditional pharmaceutical partnerships and collaborations with
governmental and other organizations.
Additional information on AVANT Immunotherapeutics, Inc. can be
obtained through our 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
which reflect AVANT's current views with respect to future events and
financial performance. These forward-looking statements are based on
management's beliefs and assumptions and information currently
available. The words "believe", "expect", "anticipate", "intend",
"estimate", "project" and similar expressions which do not relate
solely to historical matters identify forward-looking statements.
Investors should be cautious in relying on forward-looking statements
because they are subject to a variety of risks, uncertainties, and
other factors that could cause actual results to differ materially
from those expressed in any such forward-looking statements. These
factors include, but are not limited to: (1) the integration of
multiple technologies and programs; (2) the ability to adapt AVANT's
vectoring systems to develop new, safe and effective orally
administered vaccines against anthrax and plague or other bioterrorism
threats or emerging health care threats; (3) the ability to
successfully complete development and commercialization of TP10,
CETi-1, CholeraGarde(R) (Peru-15), Ty800 and other products; (4) the
cost, timing, scope and results of ongoing safety and efficacy trials
of TP10, CETi-1, CholeraGarde(R) (Peru-15), Ty800 and other
preclinical and clinical testing; (5) the ability to successfully
complete product research and further development, including animal,
pre-clinical and clinical studies of TP10, CETi-1, CholeraGarde(R)
(Peru-15), Ty800 and other products; (6) the ability of the Company to
manage multiple late stage clinical trials for a variety of product
candidates; (7) royalty revenues from product sales of Rotarix(R),
Megan(R)Vac 1, Megan(R)Egg and other future products; (8) changes in
existing and potential relationships with corporate collaborators; (9)
the availability, cost, delivery and quality of clinical and
commercial grade materials supplied by contract manufacturers; (10)
the timing, cost and uncertainty of obtaining regulatory approvals to
use TP10, CETi-1, CholeraGarde(R) (Peru-15) and Ty800, among other
purposes, for adults undergoing cardiac surgery, to raise serum HDL
cholesterol levels and to protect travelers and people in endemic
regions from diarrhea causing diseases, respectively; (11) the ability
to obtain substantial additional funding; (12) the ability to develop
and commercialize products before competitors; (13) the ability to
retain certain members of management; and (14) other factors detailed
from time to time in filings with the Securities and Exchange
Commission. We expressly disclaim any responsibility to update
forward-looking statements.
AVANT IMMUNOTHERAPEUTICS, INC.
CONSOLIDATED STATEMENTS OF OPERATIONS DATA
Quarter Year to Date
Ended September 30, Ended September 30,
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2004 2003 2004 2003
(Unaudited) (Unaudited)
REVENUE
Product Development
and Licensing
Agreements $144,300 $1,232,900 $2,393,100 $1,620,000
Government
Contract Revenue 334,200 733,700 1,928,800 2,029,300
Product Royalties 49,100 48,500 129,400 125,900
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Total Revenue 527,600 2,015,100 4,451,300 3,775,200
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OPERATING EXPENSE
Research and
Development 2,805,800 2,510,100 9,626,800 7,876,000
General and
Administrative 1,290,600 1,423,700 3,852,400 4,000,100
Amortization of
Acquired
Intangible Assets 248,800 248,800 746,400 746,400
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Total Operating
Expense 4,345,200 4,182,600 14,225,600 12,622,500
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Operating Loss (3,817,600) (2,167,500) (9,774,300) (8,847,300)
Investment and
Other Income,
Net 120,400 51,800 268,900 186,100
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Net Loss $(3,697,200) $(2,115,700) $(9,505,400) $(8,661,200)
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Basic and Diluted
Net Loss per
Common Share $(0.05) $(0.03) $(0.13) $(0.14)
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Weighted Average
Common Shares
Outstanding 74,118,300 64,703,000 72,510,600 61,773,500
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CONDENSED CONSOLIDATED BALANCE SHEETS
Sept. 30, Dec.31,
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2004 2003
(Unaudited)
ASSETS
Cash and Cash Equivalents $35,228,300 $20,251,000
Other Current Assets 1,386,500 2,058,000
Property and Equipment, net 2,171,700 912,700
Intangible and Other Assets, net 7,347,300 8,083,400
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Total Assets $46,133,800 $31,305,100
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LIABILITIES AND STOCKHOLDERS' EQUITY
Current Liabilities $3,812,100 $3,385,400
Noncurrent Liabilities 342,700 -
Stockholders' Equity 41,979,000 27,919,700
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Total Liabilities and
Stockholders' Equity $46,133,800 $31,305,100
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CONTACT: AVANT Immunotherapeutics, Inc.
President and CEO
Una S. Ryan, Ph.D., 781-433-0771
or
Chief Financial Officer
Avery W. Catlin, 781-433-0771
info@avantimmune.com
or
For Media:
Kureczka/Martin Associates
Joan Kureczka, 415-821-2413
jkureczka@comcast.net