AVANT Immunotherapeutics Reports Second Quarter and Six-Month Financial Results.NEEDHAM, Mass. -- AVANT Immunotherapeutics, Inc. (Nasdaq: AVAN) today reported financial results for the second quarter and first six-month period of fiscal year 2007. The Company reported a net loss of $5.5 million, or $.07 per share, for the second quarter of 2007 compared to a net loss of $5.7 million, or $.08 per share, for the second quarter of 2006. For the six months ended June 30, 2007, AVANT reported a net loss of $11.1 million, or $.15 per share, compared to a net loss of $8.6 million, or $.12 per share, for the six months ended June 30, 2006. The 2007 three and six month losses include one-time restructuring charges of $723,785. AVANT reported cash and cash equivalents of $26 million at June 30, 2007. 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 in our active product development programs. In April, we announced a restructuring of our company to reduce ongoing operational costs in certain areas no longer central to our focus. This will allow us to aggressively pursue those programs capable of creating the greatest value for AVANT as a developer of next-generation bacterial and viral vaccines. We expect this action will also reduce our quarterly burn rate by approximately 18% next year, extending our financial resources." AVANT plans to concentrate on building an enhanced portfolio of viral and bacterial vaccines for travelers and global health around AVANT's core technologies and unique development and manufacturing capabilities. As such, AVANT will continue to support key partners in their development efforts but will no longer invest its resources in biodefense research and development (R&D) activities or further invest in clinical trials for the CETi cholesterol management vaccine or TP10 programs. Further Financial Highlights The net loss for the second quarter of 2007 was comparable to the net loss for the same period in 2006. The increase in revenues primarily reflected increased product royalties offset by reduced levels of vaccine development work billable to 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. LLC (Logical Link Control) See "LANs" under data link protocol. LLC - Logical Link Control (DVC) during the second quarter of 2007. In the second quarter of 2007, AVANT recognized $875,018 in product royalty revenue consisting of $478,528 related to Paul Royalty Fund's (PRF PRF abbr. prolactin-releasing factor ) purchased interest in Rotarix[R] net royalties and $396,490 related to royalty expense payable to Cincinnati Children's Hospital Medical Center Cincinnati Children's Hospital Medical Center is a hospital in Cincinnati, Ohio. In June of 1883, a meeting of women from parish communities around Cincinnati established a mission to create a Diocesan Hospital for Children. (CCH CCH Colegio de Ciencias y Humanidades (Spanish) CCH Certified Clinical Hypnotherapist CCH Cook County Hospital CCH Certified in Classical Homeopathy CCH Country Club Hills (Fairfax City, VA, USA) ). 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. in 2007 include restructuring charges of $723,785 recorded during the second quarter. R&D expenses in the second quarter of 2007 also included $396,490 of royalty expense payable to CCH. AVANT had lower investment income in 2007, primarily reflecting lower cash balances between periods. The six-month results for 2007 reflect an increase in net loss compared to the same period in 2006. This increase in net loss primarily reflected a decrease in revenue, 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. , and a decrease in investment income. Revenues for the first six months of 2007 were $2.2 million, compared with revenues of $4.2 million for the first six months of 2006. The decrease in product development and licensing revenue in 2007 reflects a one-time milestone payment of $2.6 million recorded in the first quarter of 2006. In the first six months of 2007, AVANT recognized $1.8 million in product royalty revenue consisting of $903,210 related to PRF's purchased interest in Rotarix[R] net royalties and $850,543 related to royalty expense payable to CCH. In the first six months of 2006, AVANT recognized $550,803 in product royalty revenue related to PRF's purchased interests in Rotarix[R] net royalties. The decrease in government contracts and grants revenue in 2007 compared to 2006 primarily reflects reduced levels of vaccine development work billable to DVC in 2007. Increased operating expenses in the six-month results for 2007 primarily resulted from an increase in research and development expense of approximately $1,113,725, due primarily to restructuring charges of $723,785 recorded during the second quarter of 2007. R&D expenses include $850,543 and $600,000 of royalty expense payable to CCH at June 30, 2007 and 2006, respectively. The increase in operating expenses also resulted from higher general and administrative expenses, which are primarily due to increases in personnel-related expenses and professional services costs. AVANT had higher investment income in the first half of 2006 primarily reflecting higher cash balances between periods. The $40 million milestone payment received from PRF during the first quarter of 2006 resulted in taxable income Under the federal tax law, gross income reduced by adjustments and allowable deductions. It is the income against which tax rates are applied to compute an individual or entity's tax liability. The essence of taxable income is the accrual of some gain, profit, or benefit to a taxpayer. for AVANT. The regular taxable income generated by this transaction will be fully offset with available federal and state net operating loss carryforwards Net operating loss carryforwards Application of losses to offset earnings in future years. . AVANT recorded a provision of $372,000 in the first quarter of 2006 for the alternative minimum tax that will result from receipt of this milestone. Marketed Products GlaxoSmithKline (GSK GSK GlaxoSmithKline plc (pharmaceutical company) GSK Glycogen Synthase Kinase GSK Gruppentraining Sozialer Kompetenzen (Germany) GSK Greenland Shark (FAO fish species code) ) has continued to pursue the global commercialization of Rotarix[R], which has now been approved in over 90 markets worldwide, including the European Union European Union (EU), name given since the ratification (Nov., 1993) of the Treaty of European Union, or Maastricht Treaty, to the European Community . In June, AVANT reported that GSK had filed for market approval in the United States. If GSK achieves U.S. approval for Rotarix[R] and launches the vaccine in 2008, AVANT will receive a $10 million royalty payment from PRF. Clinical Development Program Update In February 2006, the NIAID NIAID National Institute of Allergy and Infectious Diseases. of the National Institutes of Health (NIH "Not invented here." See digispeak. NIH - The United States National Institutes of Health. ) initiated an investigational double-blind, placebo-controlled Phase 1/2 in-patient dose-escalation clinical trial aimed at demonstrating 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 AVANT's Ty800 typhoid fever typhoid fever acute, generalized infection caused by Salmonella typhi. The main sources of infection are contaminated water or milk and, especially in urban communities, food handlers who are carriers. vaccine. In May 2007, AVANT announced preliminary results in which the NIAID researchers found the single-dose, oral vaccine to be well tolerated and immunogenic im·mu·no·gen·ic adj. Producing an immune response. immunogenic producing immunity; evoking an immune response. , with over 90% of vaccinated subjects generating immune responses. Based on these excellent results, AVANT plans to further develop Ty800 to compete in the expanding typhoid fever vaccine market, which currently has over $200 million in annual sales. AVANT has subsequently announced the initiation of a company-sponsored double-blind, placebo-controlled Phase 2 dose-ranging trial of Ty800. In 2005, AVANT and its partner, the International Vaccine Institute (IVI IVI Intelligent Vehicle Initiative IVI International Vaccine Institute IVI Interchangeable Virtual Instrument IVI Intravenous Infusion IVI Interactive Video Instruction IVI Intra Venous Injection IVI Institute for Vision Improvement IVI Interactive Video Initiative ), announced the successful completion of a Phase 2 trial of CholeraGarde[R], AVANT's cholera vaccine, in Bangladesh where cholera is endemic. With support from the Gates Foundation, IVI is now planning to initiate further Phase 2 and Phase 3 studies of CholeraGarde[R] beginning around year-end 2007. In the second half of 2007, AVANT expects to initiate a Phase 1/2 trial of its ETEC ETEC enterotoxigenic Escherichia coli. ETEC Enterotoxic Escherichia coli, see there E. coli E. coli: see Escherichia coli. E. coli in full Escherichia coli Species of bacterium that inhabits the stomach and intestines. E. coli can be transmitted by water, milk, food, or flies and other insects. vaccine candidate. AVANT's long-term goal is to develop a combination vaccine containing CholeraGarde[R], Ty800, S. paratyphi A and ETEC as a "super enteric enteric /en·ter·ic/ (en-ter´ik) within or pertaining to the small intestine. en·ter·ic adj. 1. Of, relating to, or within the intestine. 2. vaccine" to address the travelers' market. Manufacturing: AVANT has the capability to manufacture vaccines for Phase 2 and 3 clinical testing to current Good Manufacturing Practices (cGMP) standards through its own state-of-the-art manufacturing facility for the production of live, attenuated Attenuated Alive but weakened; an attenuated microorganism can no longer produce disease. Mentioned in: Tuberculin Skin Test attenuated having undergone a process of attenuation. bacterial vaccines. AVANT has produced clinical trial supplies of ETEC vaccine for the Phase 1/2 study planned to start later in 2007. Webcast and Conference Call Dr. Ryan and Mr. Catlin will host a conference call and live audio webcast 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, August 2, 2007 to discuss AVANT's Second Quarter and Six-Month financial results. To access the conference call, dial 800-659-2037 (within the U.S.), or 617-614-2713 (if calling from outside the U.S.). The passcode for participants is 74142034. 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 67559598. The replay will also be broadcast via the Company's website, www.avantimmune.com, approximately two hours after the live call. 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. About AVANT Immunotherapeutics, Inc. AVANT Immunotherapeutics, Inc. discovers and develops 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. AVANT has three products on the market and three of AVANT's products are in clinical development. AVANT's pipeline includes products for travelers' vaccines and global health needs based on AVANT's oral, rapid-protecting, single-dose 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 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: The statements made in this press release which are not statements of historical fact are forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934, including, without limitation, statements that may be identified by words such as "expectations," "remains," "focus," "expected," "prospective," "expanding," "building," "continue," "progress," "plan," "efforts," "hope," "believe," "objectives," "opportunities," "will," "seek," and other expressions which are predictions of or indicate future events and trends and which do not constitute historical matters identify forward-looking statements. These statements also include statements regarding: (i) AVANT's expectations regarding its restructuring and quarterly cash burn rate, (ii) AVANT's expectations to find partnerships for the cardiovascular programs (iii) AVANT's expectations of royalty payments from PRF related to Rotarix, (iv) AVANT's expectations to initiate its own sponsored double-blind, placebo-controlled Phase 2 dose-ranging trial of Ty800 and Phase 1/2 trial of its ETEC E. coli vaccine candidate, and (v) statements made regarding AVANT's goals for its programs and products. This release includes forward-looking statements that are subject to a variety of risks and uncertainties and reflect AVANT's current views with respect to future events and financial performance. There are a number of important factors that could cause the actual results to differ materially from those expressed in any forward-looking statement made by AVANT. 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 any other microbes used as bioweapons and other disease causing agents; (3) the ability to successfully complete product research and further development, including animal, pre-clinical and clinical studies, and commercialization of CholeraGarde[R] (Peru-15), Ty800, ETEC E. coli vaccine, VLPs and other products and AVANT's expectations regarding market growth; (4) the cost, timing, scope and results of ongoing safety and efficacy trials of CholeraGarde[R] (Peru-15), Ty800, ETEC E. coli vaccine and other preclinical and clinical testing; (5) the ability to negotiate strategic partnerships or other disposition transactions for AVANT's cardiovascular programs, including TP10 and CETi; (6) the ability of AVANT to manage multiple clinical trials for a variety of product candidates; (7) AVANT's expectations regarding its technological capabilities and expanding its focus to broader markets for vaccines; (8) the Company's expectations regarding the cost of funding its development partnership with Select Vaccines Limited for the influenza vaccine influenza vaccine Flu vaccine A vaccine recommended for those at high risk for serious complications from influenza: > age 65; Pts with chronic diseases of heart, lung or kidneys, DM, immunosuppression, severe anemia, nursing home and other chronic-care , the opportunity to extend to other disease targets, and AVANT's ability to develop products through this collaboration; (9) changes in existing and potential relationships with corporate collaborators; (10) the availability, cost, delivery and quality of clinical and commercial grade materials produced at AVANT's own Manufacturing facility or supplied by contract manufacturers and partners; (11) the timing, cost and uncertainty of obtaining regulatory approvals; (12) the ability to develop and commercialize products before competitors that are superior to the alternatives developed by competitors; (13) the ability to retain certain members of management;(14) AVANT's expectations regarding research and development expenses and general and administrative expenses; (15) AVANT's expectations regarding cash balances, capital requirements Capital requirements Financing required for the operation of a business, composed of long-term and working capital plus fixed assets. , anticipated royalty payments (including those from Paul Royalty Fund), revenues and expenses, including infrastructure expenses; (16) AVANT's belief regarding the validity of its patents and potential litigation An action brought in court to enforce a particular right. The act or process of bringing a lawsuit in and of itself; a judicial contest; any dispute. When a person begins a civil lawsuit, the person enters into a process called litigation. ; and (17) certain other factors that might cause AVANT's actual results to differ materially from those in the forward-looking statements including those set forth under the headings "Business," "Risk Factors" and Management's Discussion and Analysis Management's discussion and analysis (MD&A) A report from management to shareholders that accompanies the firm's financial statements in the annual report. It explains the period's financial results and enables management to discuss topics that may not be apparent in the financial of Financial Condition and Results of Operations" in AVANT's Annual Report on Form 10-K Form 10-K A report required by the SEC from exchange-listed companies that provides for annual disclosure of certain financial information. Form 10-K See 10-K. for the year ended December 31, 2006, as well as those described in AVANT's other press releases and filings with the Securities and Exchange Commission, from time to time. You should carefully review all of these factors, and you should be aware that there may be other factors that could cause these differences. These forward-looking statements were based on information, plans and estimates at the date of this press release, and AVANT does not promise to update any forward-looking statements to reflect changes in underlying assumptions or factors, new information, future events or other changes. [TABLE OMITTED] [TABLE OMITTED] |
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