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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 27 2005
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 October 27, 2005, AVANT Immunotherapeutics, Inc. issued a press release
announcing its financial results for the third 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.
99.1 Press Release of AVANT Immunotherapeutics, Inc. dated October 27, 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: October 27, 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 October 27, 2005.
Exhibit 99.1
AVANT Immunotherapeutics Reports Third Quarter
and Nine Month Financial Results
NEEDHAM, Mass.--(BUSINESS WIRE)--Oct. 27, 2005--AVANT
Immunotherapeutics, Inc. (NASDAQ: AVAN) today reported financial
results for the third quarter and nine months ended September 30,
2005. For the quarter ended September 30, 2005, AVANT reported a net
loss of $4.5 million, or $.06 per share, compared to a net loss of
$3.7 million, or $.05 per share, for the third quarter of 2004. AVANT
reported cash and cash equivalents of $22 million at September 30,
2005.
Revenues during the third quarter of 2005 were $846,322 compared
to revenues of $527,510 for the same period last year. Total operating
expenses for the quarter were $5.5 million compared to $4.3 million in
the same quarter last year. The Company's research and development
expenses for the three-month period ended September 30, 2005 were $3.6
million compared to $2.8 million for the same period last year. The
increase in research and development expenses mostly resulted from
increased costs associated with the TP10 program, primarily clinical
trial costs for the Phase IIb study in women undergoing cardiac bypass
surgery and contract manufacturing costs incurred for process
development and scale-up work for TP10. Operating expenses also
increased as a result of full operations at the Fall River
manufacturing facility. AVANT's general and administrative expenses
were $1.7 million for the three months ended September 30, 2005
compared to $1.3 million for the same period last year. The increase
in general and administrative expenses resulted primarily from
increases in personnel-related expenses, legal fees related to patent
matters, and other professional services and consultancy costs related
to project management and Sarbanes-Oxley compliance.
The Company reported investment income of $149,662 for the quarter
compared to $120,417 for the same period last year, reflecting higher
market interest rates, offset in part by lower average cash balances
in 2005 versus 2004.
Nine Month Results
For the nine months ended September 30, 2005, the company reported
a net loss of $14.1 million, or $.19 per share, compared to a net loss
of $9.5 million, or $.13 per share, for the nine months ended
September 30, 2004.
For the nine months ended September 30, 2005, AVANT's revenues
were $2.5 million compared to $4.5 million for the nine-month period
ended September 30, 2004. The decrease in revenues resulted primarily
from the one-time recognition in 2004 of $1 million in revenue from
DVC for rPA clinical materials and the one-time recognition of an
upfront license fee of $1 million from AdProTech, Ltd. Total operating
expenses for the nine-month period ended September 30, 2005 and 2004
were $17 million and $14.2 million, respectively. Research and
development expenses were $11.1 million for the nine months ended
September 30, 2005 compared to $9.6 million for the same period last
year. The increase in research and development expenses resulted
primarily from an increase in TP10 clinical trial costs, TP10 contract
manufacturing costs and laboratory supplies incurred for process
development and scale-up work and operating expenses of the Fall River
manufacturing facility. General and administrative expenses were $5.2
million for the nine months ended September 30, 2005 compared to $3.9
million for the nine months ended September 30, 2004. The increase in
general and administrative expenses was primarily due to increases in
personnel-related expenses, legal fees associated with the PRF
transaction and patent matters, and other professional services and
consultancy costs related to project management and Sarbanes-Oxley
compliance. The increase in investment income of $201,589 reflected
higher market interest rates, offset in part by lower average cash
balances between periods.
"This quarter we were very pleased to report positive preliminary
results from a Phase II clinical trial of CholeraGarde(R) in infants
and children in Bangladesh, which reinforces the strong safety and
immunogenicity results reported last year in adults receiving this
experimental vaccine," said Una S. Ryan, Ph.D., AVANT's President and
Chief Executive Officer. "Also announced this quarter, we will be
working with Harvard Medical School to apply our VitriLife(R)
technology for vaccine thermostability to CholeraGarde(R), under a
grant from the National Institutes of Health." VitriLife(R) will allow
AVANT's vaccines to be delivered and administered without
refrigeration.
"Importantly, our development programs continue to progress," Dr.
Ryan continued. "We were pleased to announce early this month that we
had completed enrollment of the TP10 Phase IIb trial in women
undergoing high risk cardiac bypass surgery."
Clinical Development Programs
On July 27, AVANT announced results in children and infants from a
randomized, Phase II double blind, placebo-controlled study of its
single-dose, oral cholera vaccine, CholeraGarde(R), conducted in
Bangladesh by the International Centre for Diarrhoeal Disease
Research, Bangladesh in collaboration with the International Vaccine
Institute (IVI). The trial was sponsored by the Diseases of the Most
Impoverished (DOMI) Program of the IVI which is funded by the Bill and
Melinda Gates Foundation. The researchers found the vaccine to be
immunogenic and well tolerated in the vaccinated children. Over 84% of
children and 70% of infants vaccinated with the effective dose
responded with a favorable immune response. If the results in children
aged from 9 months to 5 years are grouped together, the responder
frequency was 77%. These results were consistent with results in
adults receiving vaccination with CholeraGarde(R) in an earlier
reported portion of this study, which showed a response rate of 70%.
On October 11, AVANT announced that it has completed enrollment of
the Phase IIb trial of its complement inhibitor, TP10, in female
subjects undergoing high risk cardiac surgery utilizing
cardiopulmonary bypass (CPB). The objective of this double-blind,
placebo-controlled study is to assess the safety and treatment effect
of TP10 as compared to placebo in reducing the incidence of death and
heart attack in patients undergoing cardiac surgery on CPB, thus
potentially improving post-operative outcomes. AVANT expects to report
results of this study in the first quarter of 2006. AVANT then plans
in collaboration with a corporate partner to complete development and
to commercialize TP10.
During the third quarter AVANT began vaccine production of the
plague component of its oral combination anthrax and plague vaccine at
its Fall River manufacturing facility. Also in July, AVANT reported
that it and Harvard Medical School would receive approximately
$500,000 from the National Institutes of Health to apply AVANT's
VitriLife(R) formulation to CholeraGarde(R). In the future, AVANT
plans to utilize VitriLife(R), a proprietary technology that confers
thermostability to live bacterial vaccines, at the Fall River facility
for its other bacterial vaccines.
Webcast and Conference Call
Dr. Ryan and Mr. Catlin will host a conference call at 11:00 AM
EDT on Thursday, October 27, 2005 to discuss AVANT's Third Quarter
2005 financial results. To access the conference call, dial
800-322-2803 (within the United States), or 617-614-4925 (if calling
from outside the U.S.). The passcode for participants is 15879316. 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 95666600.
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 Immunotherapeutics, Inc.
AVANT Immunotherapeutics, Inc. discovers and develops innovative
vaccines and therapeutics that harness the human immune system to
prevent and treat disease. 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 is also developing a
pipeline of bacteria-fighting products for biodefense, travelers'
vaccines, and global health needs based on AVANT'S rapid-protecting,
single-dose, oral and temperature stable vaccine technology.
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) 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)
GSK's strategy and business plans to launch and supply Rotarix (R)
worldwide, including in the US and other major markets; (10) changes
in existing and potential relationships with corporate collaborators;
(11) the availability, cost, delivery and quality of clinical and
commercial grade materials supplied by contract manufacturers; (12)
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; (13) the ability
to obtain substantial additional funding; (14) the ability to develop
and commercialize products before competitors and that are superior to
the alternatives developed by competitors; (15) the ability to retain
certain members of management; and (16) 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.
-table follows-
AVANT IMMUNOTHERAPEUTICS, INC.
CONSOLIDATED STATEMENTS Quarter Year to Date
OF OPERATIONS DATA Ended September 30, Ended September 30,
- ----------------------------------------------------------------------
2005 2004 2005 2004
(Unaudited) (Unaudited)
REVENUE
Product Development
and Licensing
Agreements $ 78,692 $ 144,280 $ 209,209 $ 2,393,118
Government Contracts
and Grants 767,630 334,166 2,156,680 1,928,712
Product Royalties - 49,064 88,146 129,388
- ----------------------------------------------------------------------
Total Revenue 846,322 527,510 2,454,035 4,451,218
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OPERATING EXPENSE
Research and
Development 3,591,334 2,805,813 11,052,944 9,626,816
General and
Administrative 1,670,306 1,290,567 5,242,185 3,852,413
Amortization of
Acquired
Intangible Assets 248,778 248,778 746,334 746,334
- ----------------------------------------------------------------------
Total Operating
Expense 5,510,418 4,345,158 17,041,463 14,225,563
- ----------------------------------------------------------------------
Operating Loss (4,664,096) (3,817,648) (14,587,428) (9,774,345)
Investment
Income, Net 149,662 120,417 470,556 268,967
- ----------------------------------------------------------------------
Net Loss $ (4,514,434)$(3,697,231)$(14,116,872)$ (9,505,378)
- ----------------------------------------------------------------------
Basic and
Diluted Net
Loss per Common
Share $ (0.06) $ (0.05) $ (0.19) $ (0.13)
- ----------------------------------------------------------------------
Weighted
Average
Common
Shares
Outstanding 74,145,814 74,118,314 74,136,931 72,510,640
- ----------------------------------------------------------------------
CONDENSED CONSOLIDATED
BALANCE SHEETS September 30, December 31,
- ----------------------------------------------------------------------
2005 2004
(Unaudited)
ASSETS
Cash and Cash Equivalents $ 22,198,775 $ 31,741,494
Other Current Assets 6,394,134 2,798,266
Property and Equipment, net 5,119,239 4,164,292
Intangible and Other Assets, net 6,352,136 7,099,470
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Total Assets $ 40,064,284 $ 45,803,522
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LIABILITIES AND STOCKHOLDERS' EQUITY
Current Liabilities $ 3,585,612 $ 5,450,948
Long-Term Liabilities 11,790,552 1,944,948
Stockholders' Equity 24,688,120 38,407,626
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Total Liabilities and
Stockholders' Equity $ 40,064,284 $ 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
For Media:
Kureczka/Martin Associates
Joan Kureczka, 415-821-2413
jkureczka@comcast.net