-----BEGIN PRIVACY-ENHANCED MESSAGE----- Proc-Type: 2001,MIC-CLEAR Originator-Name: webmaster@www.sec.gov Originator-Key-Asymmetric: MFgwCgYEVQgBAQICAf8DSgAwRwJAW2sNKK9AVtBzYZmr6aGjlWyK3XmZv3dTINen TWSM7vrzLADbmYQaionwg5sDW3P6oaM5D3tdezXMm7z1T+B+twIDAQAB MIC-Info: RSA-MD5,RSA, I//dPXlgjY1ukaA7qdPmmpRaSYCEbPkJSJq6TBczLS72eEEo2Mmn1HM7moOM/oDy fBUakbdtE7Nnx1H3E57SYQ== 0001157523-05-004343.txt : 20050505 0001157523-05-004343.hdr.sgml : 20050505 20050505100135 ACCESSION NUMBER: 0001157523-05-004343 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 2 CONFORMED PERIOD OF REPORT: 20050505 ITEM INFORMATION: Results of Operations and Financial Condition ITEM INFORMATION: Financial Statements and Exhibits FILED AS OF DATE: 20050505 DATE AS OF CHANGE: 20050505 FILER: COMPANY DATA: COMPANY CONFORMED NAME: AVANT IMMUNOTHERAPEUTICS INC CENTRAL INDEX KEY: 0000744218 STANDARD INDUSTRIAL CLASSIFICATION: IN VITRO & IN VIVO DIAGNOSTIC SUBSTANCES [2835] IRS NUMBER: 133191702 STATE OF INCORPORATION: DE FISCAL YEAR END: 1231 FILING VALUES: FORM TYPE: 8-K SEC ACT: 1934 Act SEC FILE NUMBER: 000-15006 FILM NUMBER: 05801632 BUSINESS ADDRESS: STREET 1: 119 FOURTH AVE CITY: NEEDHAM STATE: MA ZIP: 02494 BUSINESS PHONE: 7814330771 MAIL ADDRESS: STREET 1: 119 FOURTH AVE CITY: NEEDHAM STATE: MA ZIP: 021942725 FORMER COMPANY: FORMER CONFORMED NAME: T CELL SCIENCES INC DATE OF NAME CHANGE: 19920703 8-K 1 a4881082.txt AVANT IMMUNOTHERAPEUTICS, INC. ================================================================================ 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 ----------- Commission file number 0-15006 ------- AVANT Immunotherapeutics, Inc. (Exact name of registrant as specified in its charter) -------------------- 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) -------------------- 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)) =============================================================================== 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. - ---------- ------------------------------------------------------------------ 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. EX-99.1 2 a4881082ex991.txt EXHIBIT 99.1 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, - --------------------------------------------------------------------- 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 - --------------------------------------------------------------------- Total Operating Revenue 970,552 3,030,697 - --------------------------------------------------------------------- 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 - --------------------------------------------------------------------- Total Operating Expense 5,990,180 4,994,113 - --------------------------------------------------------------------- Operating Loss (5,019,628) (1,963,416) Investment Income, Net 151,129 54,002 - --------------------------------------------------------------------- Net Loss $(4,868,499) $(1,909,414) - --------------------------------------------------------------------- Basic and Diluted Net Loss per Common Share $(0.07) $(0.03) - --------------------------------------------------------------------- Weighted Average Common Shares Outstanding 74,231,999 69,169,571 - --------------------------------------------------------------------- CONDENSED CONSOLIDATED BALANCE SHEETS March 31, December 31, - --------------------------------------------------------------------- 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 --------------- --------------- Total Assets $40,174,444 $45,803,522 =============== =============== 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 --------------- --------------- 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 -----END PRIVACY-ENHANCED MESSAGE-----