Avant Immunotherapeutics Reports Second Quarter Fiscal 2004 Financial Results.NEEDHAM, Mass. -- AVANT Immunotherapeutics, Inc. (Nasdaq: AVAN) today reported financial results for the second quarter ended June 30, 2004. The company reported a net loss of $3.9 million, or $.05 per share, for the second quarter of 2004 compared to a net loss of $3.2 million, or $.05 per share, for the second quarter of 2003. For the six months ended June 30, 2004, the company reported a net loss of $5.8 million, or $.08 per share, compared to a net loss of $6.5 million, or $.11 per share, for the six months ended June 30, 2003. The increased loss for the second quarter of 2004 of $715,500, or 22.5%, primarily reflects an increase in operating expense Operating Expense The essential things that a company must purchase in order to maintain business. Notes: For example, the payment of employees wages are an operating expense. Also known as OPEX. compared to the same period in 2003. The increase in operating expense is primarily due to increased clinical trial costs associated with the ongoing TP10 Phase IIb study in women undergoing cardiac bypass surgery Bypass surgery A surgical procedure that grafts blood vessels onto arteries to reroute the blood flow around blockages in the arteries (arteriosclerosis). and TP10 contract manufacturing costs incurred for process development and scale-up work in preparation for the production of Phase III Noun 1. phase III - a large clinical trial of a treatment or drug that in phase I and phase II has been shown to be efficacious with tolerable side effects; after successful conclusion of these clinical trials it will receive formal approval from the FDA clinical materials in 2005. The increase in investment income reflected higher average cash balances in 2004. At June 30, 2004, AVANT reported cash and cash equivalents of $39.4 million. The six-month results for 2004 reflect a decrease in net loss of $737,300, or 11.3%, compared to the same period in 2003. This decrease in net loss primarily reflects an increase in revenue and an increase in investment income, offset in part by an increase in operating expense. The increase in revenue in 2004 results primarily from the recognition of $1 million in revenue from DynPort Vaccine Company LLC (Logical Link Control) See "LANs" under data link protocol. LLC - Logical Link Control ("DVC (1) (Digital Video Camera) A camcorder that records in digital format. See DV. (2) (Digital Video Cassette) An earlier term for the DV format. See DV. (3) See desktop videoconferencing. ") for rPA clinical materials and the recognition of an upfront license fee of $1 million from AdProTech, Ltd. The increase in operating expense results primarily from an increase in clinical trials costs and contract manufacturing costs incurred on the company's TP10 complement inhibitor program. The increase in investment income reflects 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. We expect, however, that operating expenses Operating expenses The amount paid for asset maintenance or the cost of doing business, excluding depreciation. Earnings are distributed after operating expenses are deducted. will increase further in the third and fourth quarters of 2004 as we begin to prepare our TP10 program in cardiac surgery Cardiac surgery is surgery on the heart and/or great vessels performed by a cardiac surgeon. Frequently, it is done to treat complications of ischemic heart disease (for example, coronary artery bypass grafting), correct congenital heart disease, or treat valvular heart disease for an anticipated Phase III trial by the end of 2005. Net loss for 2004 is now forecasted to be in the range of $17-$19 million." Shortly after the close of the quarter, we were pleased to announce that the Mexican Board of Health approved the marketing of Rotarix(R) in Mexico. In addition, we had several noteworthy accomplishments during the second quarter which further prepare us to become a commercial company including: --The award of an additional subcontract sub·con·tract n. A contract that assigns some of the obligations of a prior contract to another party. intr. & tr.v. sub·con·tract·ed, sub·con·tract·ing, sub·con·tracts by DVC for $3 million to support the human clinical testing of a plague vaccine plague vaccine n. A vaccine prepared from live, killed, or attenuated Yersinia pestis used to immunize against bubonic plague. candidate being developed by AVANT for use in our oral combination vaccine against anthrax anthrax (ăn`thrăks), acute infectious disease of animals that can be secondarily transmitted to humans. It is caused by a bacterium (Bacillus anthracis and plague. --Presentation of data at a recent scientific meeting showing that four of AVANT's vaccines manufactured and dried using the VitriLife(R) preservation technology remain stable and immunogenic im·mu·no·gen·ic adj. Producing an immune response. immunogenic producing immunity; evoking an immune response. even when stored at or above normal room temperatures. --Initiation by The Walter Reed Army Institute of Research This article is about the U.S. Army medical research institute (not the hospital). Otherwise, see Walter Reed (disambiguation). The Walter Reed Army Institute of Research (WRAIR) is the largest biomedical research facility administered by the U.S. (WRAIR WRAIR Walter Reed Army Institute of Research ) of a placebo-controlled, Phase I clinical trial Noun 1. phase I clinical trial - a clinical trial on a few persons to determine the safety of a new drug or invasive medical device; for drugs, dosage or toxicity limits should be obtained phase I to assess the safety and immunogenicity immunogenicity /im·mu·no·ge·nic·i·ty/ (-je-nis´it-e) the property enabling a substance to provoke an immune response, or the degree to which a substance possesses this property. of an HIV vaccine HIV vaccine AIDS As of mid-2005, there is no viable anti-HIV vaccine. See AIDS. based on AVANT's Therapore(R) technology. --Expansion of our senior management team with the appointment of Timothy Cooke, Ph.D., as Senior Vice President, Commercial Development. --Receipt of a building permit for our pilot manufacturing facility in Fall River and the start of construction. This facility will implement our VitriLife(R) technology. Rotarix(R) Vaccine Last week we announced that our partner, GlaxoSmithKline Biologicals (GSK GSK GlaxoSmithKline plc (pharmaceutical company) GSK Glycogen Synthase Kinase GSK Gruppentraining Sozialer Kompetenzen (Germany) GSK Greenland Shark (FAO fish species code) ), had received approval from the Mexican Board of Health to market Rotarix(R) in Mexico for the prevention of gastroenteritis gastroenteritis: see enteritis. gastroenteritis Acute infectious syndrome of the stomach lining and intestines. Symptoms include diarrhea, vomiting, and abdominal cramps. caused by rotavirus infection rotavirus infection Virology RI is usually mild, but may be severe in children ≤ 2 yrs due to intense vomiting Morbidity > 870,000 children < age 5 die of rotavirus infection in developing countries, in contrast to 75 to 150 in the US Epidemiology . "We are delighted to announce this initial approval for Rotarix(R), which marks a significant milestone for AVANT - the first commercial approval of a human healthcare product from AVANT's extensive portfolio of advanced vaccines," said Una S. Ryan, AVANT President and Chief Executive Officer. "We anticipate that this is just the first of a series of marketing approvals for Rotarix(R) as GSK continues its worldwide development efforts for this vaccine." More than 70,000 infants have been enrolled in the global clinical development program, with studies conducted in Europe, the US, Latin America Latin America, the Spanish-speaking, Portuguese-speaking, and French-speaking countries (except Canada) of North America, South America, Central America, and the West Indies. and Asia to evaluate the safety and efficacy of Rotarix(R). These studies demonstrate that Rotarix(R) is an effective, safe and well-tolerated vaccine. TP10 for Cardiac Surgery We anticipate completing enrollment in the Phase IIb study in women undergoing cardiac bypass surgery by the end of this year. We are working closely with our partner, Lonza Biologics plc, to complete process development and scale-up efforts this year in preparation for the production of Phase III clinical materials and the start of that trial by year-end 2005. CETP CETP Cholesteryl Ester Transfer Protein CETP Certified Employee Training Program CETP Common Effluent Treatment Plant CETP China Energy Technology Program CETP Centre de Recherches en Physique de l'Environment Terrestre et Planetaire (French) 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 expect 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 EDT abbr. Eastern Daylight Time EDT Eastern Daylight Time EDT n abbr (US) (= Eastern Daylight Time) → hora de verano de Nueva York EDT on Thursday, July 22, 2004 to discuss AVANT's Second Quarter 2004 financial results. To access the conference call, dial 800-599-9829 (within the United States United States, officially United States of America, republic (2005 est. pop. 295,734,000), 3,539,227 sq mi (9,166,598 sq km), North America. The United States is the world's third largest country in population and the fourth largest country in area. ), or 617-847-8703 (if calling from outside the U.S.). The passcode for participants is 35032838. 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 21484786. 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 Digital jukebox software for Windows from Microsoft that plays a variety of audio, video and streaming formats including MP3, WMA, CD audio and MIDI. Starting with Version 6.2 in 1999, the Windows Media Rights Manager was added for securing copyrighted content. 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 Investor relations The process by which the corporation communicates with its investors. at (781) 433-0771. AVANT Immunotherapeutics, Inc. discovers, develops and sells innovative vaccines and therapeutics that harness the human immune system immune system Cells, cell products, organs, and structures of the body involved in the detection and destruction of foreign invaders, such as bacteria, viruses, and cancer cells. Immunity is based on the system's ability to launch a defense against such invaders. 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 rotavirus /ro·ta·vi·rus/ (ro´tah-vi?rus) any member of the genus Rotavirus. ro´taviral Rotavirus /Ro·ta·vi·rus/ (ro´tah-vi?rus 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 refrigeration, process for drawing heat from substances to lower their temperature, often for purposes of preservation. Refrigeration in its modern, portable form also depends on insulating materials that are thin yet effective. . 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 Safe Harbor 1. A legal provision to reduce or eliminate liability as long as good faith is demonstrated. 2. A form of shark repellent implemented by a target company acquiring a business that is so poorly regulated that the target itself is less attractive. Statement Under the Private Securities Litigation Reform Act The Private Securities Litigation Reform Act of 1995 (PSLRA) implemented several significant substantive changes affecting certain cases brought under the federal securities laws, including changes related to pleading, discovery, liability, class representation and awards fees and of 1995: This release includes forward-looking statements forward-looking statement A projected financial statement based on management expectations. A forward-looking statement involves risks with regard to the accuracy of assumptions underlying the projections. 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 HDL cholesterol n. See high-density lipoprotein. HDL Cholesterol About one-third or one-fourth of all cholesterol is high-density lipoprotein 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 Quarter Year to Date
DATA Ended June 30, Ended June 30,
----------------------------------------------------------------------
2004 2003 2004 2003
(Unaudited) (Unaudited)
REVENUE
Product
Development and
Licensing
Agreements $124,400 $187,000 $2,248,800 $333,800
Government
Contracts and
Grants 714,700 849,300 1,594,600 1,348,900
Product Royalties 53,900 42,100 80,300 77,400
----------------------------------------------------------------------
Total Revenue 893,000 1,078,400 3,923,700 1,760,100
----------------------------------------------------------------------
OPERATING EXPENSE
Research and
Development 3,367,800 2,673,400 6,821,000 5,365,900
General and
Administrative 1,269,700 1,351,700 2,561,800 2,576,400
Amortization of
Acquired
Intangible Assets 248,800 248,800 497,600 497,600
----------------------------------------------------------------------
Total Operating
Expense 4,886,300 4,273,900 9,880,400 8,439,900
----------------------------------------------------------------------
Operating Loss (3,993,300) (3,195,500) (5,956,700) (6,679,800)
Investment
Income, Net 94,500 12,200 148,500 134,300
----------------------------------------------------------------------
Net Loss $(3,898,800) $(3,183,300) $(5,808,200) $(6,545,500)
----------------------------------------------------------------------
Basic and Diluted
Net Loss per
Common Share $(0.05) $(0.05) $(0.08) $(0.11)
----------------------------------------------------------------------
Weighted Average
Common Shares
Outstanding 74,091,600 60,468,700 71,655,100 60,468,700
----------------------------------------------------------------------
CONDENSED CONSOLIDATED
BALANCE SHEETS March 31, December 31,
----------------------------------------------------------------------
2004 2003
(Unaudited)
ASSETS
Cash and Cash Equivalents $39,370,700 $20,251,000
Other Current Assets 830,400 2,058,000
Property and Equipment, net 1,113,200 912,700
Intangible and Other Assets, net 7,585,800 8,083,400
------------ ------------
Total Assets $48,900,100 $31,305,100
============ ============
LIABILITIES AND STOCKHOLDERS' EQUITY
Current Liabilities $3,329,300 $3,385,400
Stockholders' Equity 45,570,800 27,919,700
------------ ------------
Total Liabilities and Stockholders' Equity $48,900,100 $31,305,100
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