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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): May 5, 2005
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Commission file number 0-15006
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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 May 5, 2005, AVANT Immunotherapeutics, Inc. issued a press release announcing
its financial results for the first quarter of 2005. 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 May 5, 2005.
[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: May 5, 2005 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 May 5, 2005.
Exhibit 99.1
AVANT Reports First Quarter 2005 Financial Results
NEEDHAM, Mass.--(BUSINESS WIRE)--May 5, 2005--AVANT
Immunotherapeutics, Inc. (Nasdaq: AVAN) today reported financial
results for the first quarter ended March 31, 2005. The Company
reported a net loss of $4.9 million, or $0.07 per share, for the first
quarter of 2005 compared to a net loss of $1.9 million, or $0.03 per
share, for the first quarter of 2004. The increase in net loss between
periods primarily reflects a decrease in product development and
licensing revenues combined with an increase in operating expenses. At
March 31, 2005, AVANT reported cash and cash equivalents of $27.3
million.
Revenues for the first quarter of 2005 were $970,522 compared with
revenues of $3 million for the first quarter of 2004. The decrease in
revenues reflects one-time recognition in 2004 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, together with a decrease in government contract revenues from DVC
in 2005 compared to 2004. Increased operating expenses were primarily
a result of an increase in research and development expenses due to an
increase in TP10 contract manufacturing costs incurred for process
development and scale-up work and operating expenses of the Fall River
manufacturing facility. The increase in operating expenses further
resulted from an increase in general and administrative expenses
primarily due to increases in personnel-related expenses and
professional services and consultancy costs. AVANT had higher
investment income in 2005 primarily reflecting higher interest rates
between periods.
Una S. Ryan, Ph.D., AVANT's President and Chief Executive Officer,
said, "These financial results were consistent with our expectations.
We are pleased with the progress of our programs during the first
quarter of 2005."
-- We were delighted to announce that our partner GlaxoSmithKline
(GSK) had filed in late 2004 for market approval of Rotarix(R)
with the European regulatory authorities, triggering a $2
million milestone payment received by AVANT in January and
recognized as revenue in 2004.
-- Also in January, GSK announced the launch of Rotarix(R) in
Mexico, representing the first step in a series of global
product launches to begin this year.
-- During the quarter, we received subcontract modifications from
DVC, which incorporated a portion of the Fiscal 2004 Defense
Bill Appropriations, increasing our contracted funding by $2.4
million. Contracted funding for our oral, combination
anthrax/plague vaccine program now exceeds $7 million. Total
government funding commitments approximate $10 million to
cover vaccine development through preclinical testing.
-- Finally, we have completed the construction of our Fall River
vaccine manufacturing facility and have begun the validation
process. This facility will produce AVANT's single dose, oral
vaccines incorporating our VitriLife(R) technology.
Marketed Programs
Addressing a worldwide market opportunity estimated by GSK at $1.8
billion, GSK has filed for market approval of Rotarix(R) in more than
30 countries worldwide as well as with the European regulatory
authorities. AVANT expects royalty revenues from Rotarix(R) sales to
begin in the second quarter of 2005.
Clinical Development Programs
Because of slow enrollment in our Phase IIb study of TP10 in women
undergoing cardiac bypass surgery, we have added new study sites and
taken other steps to increase enrollment. As a result, we now expect
to complete this trial around year-end 2005 or early 2006. The aim of
the trial is to augment the safety data for TP10 and further define
its effect in women before advancing to a Phase III study. AVANT is
seeking to partner the TP10 program prior to starting a Phase III
trial.
With respect to our CETi program, in preclinical studies we have
identified a new adjuvanted formulation for the vaccine that elicits
more than a 10-fold increase in anti-CETP antibody titers when
compared to the current CETi-1 vaccine. We have contracted for the
production of GMP peptide for the newly formulated vaccine. AVANT is
seeking a development partner for this program.
In 2005, AVANT expects to report two additional achievements.
First, our partner, the International Vaccine Institute (IVI), should
announce results in mid-year of the pediatric portion of the Phase II
trial of AVANT's oral cholera vaccine ongoing in Bangladesh where
cholera is endemic. Second, the National Institutes of Health (NIH)
should initiate a Phase I/II clinical trial in approximately 50
subjects aimed at demonstrating the safety and immunogenicity of
AVANT's typhoid fever vaccine, Ty800, at an NIH-funded clinical site.
Webcast and Conference Call
Dr. Ryan and Mr. Catlin will host a conference call at 11:00 AM
EDT on Thursday, May 5, 2005 to discuss AVANT's First Quarter 2005
financial results. To access the conference call, dial 866-800-8651
(within the United States), or 617-614-2704 (if calling from outside
the U.S.). The passcode for participants is 76986438. 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 79116443.
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.
About AVANT
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. Three of AVANT's products are
marketed, including two food safety vaccines and 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 bypass 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. Further, AVANT has established a state-of-the-art vaccine
manufacturing facility for the implementation of its VitriLife(R)
technology and the production of its proprietary vaccines. AVANT's
goal is to demonstrate proof-of-concept for its products in the clinic
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), Ty800and 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, Megan(R)Egg and other future products; (8) the process
of obtaining regulatory approval for the sale of Rotarix(R) in major
commercial markets, as well as the timing and success of worldwide
commercialization of Rotarix(R) by our partner, GlaxoSmithKline; (9)
changes in existing and potential relationships with corporate
collaborators; (10) the availability, cost, delivery and quality of
clinical and commercial grade materials supplied by contract
manufacturers; (11) 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; (12) the ability to obtain substantial
additional funding; (13) the ability to develop and commercialize
products before competitors; (14) the ability to retain certain
members of management; and (15) 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,
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2005 2004
(Unaudited)
OPERATING REVENUE
Product Development
and Licensing Agreements $71,457 $2,124,419
Government Contract Revenue 866,087 879,908
Product Royalties 33,008 26,370
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Total Operating Revenue 970,552 3,030,697
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OPERATING EXPENSE
Research and Development 4,030,618 3,453,200
General and Administrative 1,710,784 1,292,135
Amortization of Acquired Intangible
Assets 248,778 248,778
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Total Operating Expense 5,990,180 4,994,113
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Operating Loss (5,019,628) (1,963,416)
Investment Income, Net 151,129 54,002
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Net Loss $(4,868,499) $(1,909,414)
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Basic and Diluted Net Loss per
Common Share $(0.07) $(0.03)
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Weighted Average Common
Shares Outstanding 74,231,999 69,169,571
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CONDENSED CONSOLIDATED
BALANCE SHEETS March 31, December 31,
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2005 2004
(Unaudited)
ASSETS
Cash and Cash Equivalents $27,309,120 $31,741,494
Other Current Assets 1,585,196 2,798,266
Property and Equipment, net 4,430,436 4,164,292
Intangible and Other Assets, net 6,849,692 7,099,470
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Total Assets $40,174,444 $45,803,522
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LIABILITIES AND STOCKHOLDERS' EQUITY
Current Liabilities $4,597,834 $5,450,948
Long-Term Liabilities $1,914,001 1,944,948
Stockholders' Equity 33,662,609 38,407,626
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Total Liabilities and
Stockholders' Equity $40,174,444 $45,803,522
=============== ===============
CONTACT: AVANT Immunotherapeutics, Inc.
Una S. Ryan, Ph.D., 781-433-0771
President and CEO
or
AVANT Immunotherapeutics, Inc.
Avery W. Catlin, 781-433-0771
Chief Financial Officer
info@avantimmune.com
or
Kureczka/Martin Associates
Joan Kureczka, 415-821-2413
jkureczka@comcast.net