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UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 8-K
CURRENT REPORT
Pursuant to Section 13 or 15(d) of the
Securities Exchange Act of 1934
Date of Report (Date of earliest event reported):
April 30, 2003
AVANT IMMUNOTHERAPEUTICS, INC.
(Exact name of registrant as specified in charter)
Delaware 0-15006 13-3191702
(State or other jurisdiction (Commission file number) (IRS employer
of incorporation) identification no.)
119 Fourth Avenue
Needham, Massachusetts 02494
(Address of principal executive offices) (Zip code)
Registrant's telephone number, including area code:
(781) 433-0771
ITEM 7. FINANCIAL STATEMENTS, PRO FORMA FINANCIAL INFORMATION AND EXHIBITS.
(c) Exhibits.
99.1 The Company's Press Release dated April 30, 2003.
ITEM 9. REGULATION FD DISCLOSURE..
The following information is furnished under Item 12 of Form 8-K
"Results of Operations and Financial Condition". This information
is being furnished and shall not be deemed "filed" for the
purposes of Section 18 of the Securities Exchange Act of 1934 or
otherwise subject to the liabilities of that Section. The
information in this Current Report on Form 8-K shall not be
incorporated by reference into any registration statement or
other document pursuant to the Securities Act of 1933 as amended.
On April 30, 2003, the Company issued a press release which is
attached to this Form 8-K as Exhibit 99.1.
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the
Registrant has duly caused this report to be signed on its behalf by the
undersigned hereunto duly authorized.
AVANT IMMUNOTHERAPEUTICS, INC.
Date: April 30, 2003 By: /s/ Avery W. Catlin
--------------------------------------
Avery W. Catlin
Senior Vice President and
Chief Financial Officer
EXHIBIT INDEX
Exhibit Sequential
Number Description Page Number
- ------- ----------- -----------
99.1 The Company's Press Release 6
dated April 30, 2003
Exhibit 99.1
AVANT Immunotherapeutics Reports
First Quarter 2003 Financial Results
NEEDHAM, Mass.--(BUSINESS WIRE)--April 30, 2003--AVANT
Immunotherapeutics, Inc. (Nasdaq: AVAN) today reported financial
results for the first quarter ended March 31, 2003. The company
reported a net loss of $3.4 million, or $.06 per share, for the first
quarter of 2003 compared to a net loss of $4.9 million, or $.08 per
share, for the first quarter of 2002. The decreased loss for the first
quarter of 2003 primarily reflects a decrease in operating expense
compared to the same period in 2002, offset in part by a decrease in
investment income. The decrease in operating expense of $1.6 million
primarily results from a reduction in research and development
expenses in the first quarter of 2003 due to decreased clinical trials
costs and contract manufacturing costs. During the first quarter of
2003, AVANT conducted fewer clinical trials as a result of the
discontinuance of the company's TP10 trials during the first quarter
of 2002 and the completion of the CholeraGarde(TM) Phase II
dose-ranging study in 2002. The reduction in manufacturing costs
associated with the bacterial vaccines programs was due to limited
contract manufacturing activity during the first quarter of 2003. The
decrease in operating expense further resulted from declines in
personnel and related expenses, sponsored research and manufacturing
consultancy costs, offset in part by increases in license fees,
facility-related costs, insurance and legal expenses. The decrease in
investment income reflects lower average cash balances between periods
and lower interest rates. The company ended the quarter with cash and
cash equivalents of $19.8 million.
"Operating expenses are in line with our plans for the company,"
said Avery W. Catlin, Senior Vice President and Chief Financial
Officer of AVANT Immunotherapeutics, Inc. "The delay in the award of
the new Department of Defense subcontract until late January resulted
in revenues being below our expectations during this quarter. In the
second quarter of 2003, we anticipate that revenues will be more in
line with our previous guidance," continued Mr. Catlin.
Review of Additional Events During the Quarter
Bioterrorism Vaccines
In January, AVANT was awarded a new Department of Defense (DoD)
subcontract from its partner, DynPort Vaccine Company LLC (DVC) that
supports the development of the first oral, combination vaccine
against both anthrax and plague using AVANT's vectored vaccine
technology. Under the agreement, AVANT may receive in excess of $8
million over a two-year period, covering vaccine development through
preclinical testing. During the quarter, AVANT has continued to be
active in ongoing discussions with the U.S. government regarding
development of additional vaccines to protect against bioterrorism
agents.
"This contract represents one of the first awards from a major
U.S. Department of Defense (DoD) initiative to apply modern
biotechnological innovations to the development of vaccines that can
offer rapid, effective protection from multiple biological agents,"
said Una S. Ryan, Ph.D., President and Chief Executive Officer of
AVANT Immunotherapeutics, Inc. "This contract is very important to
AVANT since it provides non-dilutive funding to the company and it
means that AVANT now has cash on hand to meet our expected burn rates
through 2004. It is also the third vaccine project for which we've
received governmental funding, following our subcontract with DVC on a
next-generation injectable anthrax vaccine, now in clinical testing,
and support from the National Institutes of Health for an oral anthrax
vaccine."
Bacterial Vaccines
On January 13, 2003, AVANT announced it had been awarded a Phase I
Small Business Innovation Research (SBIR) grant to support further
preclinical development of Ty800, the company's single dose, oral
typhoid vaccine. The National Institute of Allergy and Infectious
Diseases (NIAID) of the National Institutes of Health (NIH) awarded
this grant titled "Feasibility Evaluation of an Oral Typhoid Fever
Vaccine", which provides approximately $127,000 in funding to AVANT
over a six-month period. In addition, the NIAID and AVANT have agreed
for the NIAID to conduct a Phase I in-patient dose-ranging clinical
trial aimed at demonstrating the safety and immunogenicity of the
Ty800 oral vaccine. The trial is planned for a NIAID-funded clinical
site using NIAID-funded clinical materials. The NIAID trial seeks to
confirm the safety and immunogenicity of the Ty800 oral vaccine
observed in an earlier physician-sponsored Ty800 vaccine study.
Cholesterol Management Vaccine
During the quarter, AVANT also announced the signing of an
agreement with Pharmacia Corporation (NYSE: PHA) for the acquisition
of intellectual property, including a portfolio of pending patent
applications. These patent applications are directed to products or
methods for stimulating an immune response against cholesteryl ester
transfer protein (CETP), which mediates an important cholesterol
transport mechanism. The acquisition of Pharmacia's portfolio of
pending patent applications, coupled with AVANT's September 2001
acquisition of a portfolio of granted and pending patents from The
Immune Response Corporation, consolidates AVANT's ownership of patent
applications that cover the technology of anti-atherosclerosis
vaccines.
AVANT's cholesterol management agent, CETi-1, is designed to raise
serum HDL (high-density lipoprotein) cholesterol levels by blocking
the transfer of cholesterol from HDL to LDL (low-density lipoprotein).
The principle of the CETi-1 approach is to harness an individual's own
immune system by periodic vaccinations to control the activity of
CETP, which transfers cholesterol from HDL to LDL, and to thereby
improve HDL levels. Elevated HDL or "good cholesterol" acts to protect
against atherosclerosis, while elevated LDL or "bad cholesterol" acts
to promote atherosclerosis. This product is currently completing a
Phase II clinical trial, with results expected in Q4 2003.
Dr. Ryan and Mr. Catlin will host a conference call at 11:00 AM
EDT on Wednesday, April 30, 2003 to discuss the First Quarter 2003
financial results. To access the conference call, dial 800-388-8975
(within the United States), or 973-694-2225 (if calling from outside
the U.S.). An audio replay will be available within two hours
following the call for approximately one week and can be accessed by
dialing 800-428-6051 (within the U.S.), or 973-709-2089 (if calling
from outside the U.S.). The passcode for the audio replay is 291258.
A live webcast of the conference call, together with this press
release, can be accessed through the company's website
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 or by written request to:
Investor Relations
AVANT Immunotherapeutics, Inc.
119 Fourth Avenue
Needham, MA 02194-2725
AVANT Immunotherapeutics, Inc. is engaged in the discovery,
development and commercialization of products that harness the human
immune system to prevent and treat disease. The company is developing
a broad portfolio of vaccines addressing a wide range of applications
including bacterial and viral diseases, chronic human disease,
biodefense and food safety. These include single-dose, oral vaccines
that protect against important disease-causing agents and a novel,
proprietary vaccine candidate for cholesterol management. AVANT's goal
is to demonstrate proof-of-concept for its products before leveraging
their value through partnerships. Current collaborations encompass the
development of an oral human rotavirus vaccine, vaccines to combat
threats of biological warfare, and vaccines addressed to human food
safety and animal health.
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 the
UPT technology 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 any other microbes
used as bioweapons; (3) the ability to successfully complete
development and commercialization of CETi-1, CholeraGarde(TM)
(Peru-15), Ty800 and of other products; (4) the cost, timing, scope
and results of ongoing safety and efficacy trials of CETi-1,
CholeraGarde(TM) (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 CETi-1, CholeraGarde(TM) (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) the volume
and profitability of product sales of Megan(R)Vac 1 and other future
products; (8) changes in existing and potential relationships with
corporate collaborators; (9) the 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 CETi-1, CholeraGarde(TM) (Peru-15) and
Ty800, among other purposes, to raise serum HDL cholesterol levels, to
protect travelers and people in endemic regions from diarrhea causing
diseases and for other products; (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 STATEMENT Quarter
OF OPERATIONS DATA Ended March 31,
2003 2002
(Unaudited)
OPERATING REVENUE
Product Development
and Licensing Agreements $169,400 $585,300
Government Contract Revenue 477,000 -
Product Royalties 35,300 -
Product Sales - 105,600
Total Operating Revenue 681,700 690,900
OPERATING EXPENSE
Research and Development 2,692,500 4,409,600
Selling, General and Administrative 1,224,700 1,185,900
Cost of Product Sales - 13,700
Amortization of Acquired Intangible
Assets 248,800 198,800
Total Operating Expense 4,166,000 5,808,000
Operating Loss (3,484,300) (5,117,100)
Investment Income, Net 122,100 203,500
Net Loss $(3,362,200) $(4,913,600)
Basic and Diluted Net Loss per
Common Share $(0.06) $(0.08)
Weighted Average Common
Shares Outstanding 60,468,600 60,457,400
CONDENSED CONSOLIDATED
BALANCE SHEETS March 31, December 31,
2003 2002
(Unaudited)
ASSETS
Cash and Cash Equivalents $19,750,400 $25,070,700
Other Current Assets 1,171,000 789,300
Property and Equipment, net 1,114,000 1,119,500
Intangible and Other Assets, net 9,984,500 8,253,700
Total Assets $32,019,900 $35,233,200
LIABILITIES AND STOCKHOLDERS' EQUITY
Current Liabilities $3,788,300 $3,432,600
Noncurrent Liabilities 331,800 456,200
Stockholders' Equity 27,899,800 31,344,400
Total Liabilities and Stockholders'
Equity $32,019,900 $35,233,200
CONTACT: AVANT Immunotherapeutics, Inc.
Una S. Ryan, Ph.D., 781/433-0771
or
AVANT Immunotherapeutics, Inc.
Avery W. Catlin, 781/433-0771
info@avantimmune.com
or
For Media:
Kureczka/Martin Associates
Joan Kureczka, 415/821-2413
jkureczka@aol.com