Celldex Reports Third Quarter and Nine Month Financial Results

Business Wire, Nov 5, 2008

Safe Harbor Statement Under the Private Securities Litigation Reform Act of 1995: This release includes forward-looking statements that are subject to a variety of risks and uncertainties and reflect Celldex'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 Celldex..

These factors include, but are not limited to: (1) the successful integration of the businesses, multiple technologies and programs of the two companies that merged together in 2008 to form our Company, Celldex and AVANT; (2) the ability to adopt Celldex's APC Targeting Technology(TM) to develop new, safe and effective vaccines against oncology and infectious disease indications; (3) the ability to adapt Celldex's vectoring systems to develop new, safe and effective orally administered vaccines against disease causing agents; (4) the ability to successfully complete product research and further development, including animal, preclinical and clinical studies, and commercialization of CDX-110, CDX-1307, CholeraGarde[R] (Peru-15), Ty800, ETEC E. coli vaccine, and other products and Celldex's expectations regarding market growth; (5) the cost, timing, scope and results of ongoing safety and efficacy trials of CDX-110, CDX-1307, CholeraGarde[R] (Peru-15), Ty800, ETEC E. coli vaccine and other preclinical and clinical testing; (6) the ability to negotiate strategic partnerships or other disposition transactions for Celldex's cardiovascular programs, including TP10 and CETi; (7) the ability of Celldex to manage multiple clinical trials for a variety of product candidates; (8) the volume and profitability of product sales of Megan([R])Vac 1, Megan([R])Egg and other future products; (9) GlaxoSmithKline's, or Glaxo's, 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 Glaxo, which is not within our control; (10) Glaxo's strategy and business plans to launch and supply Rotarix([R]) worldwide, including in the U.S. and other major markets, which is not within our control, and its payment of royalties to Celldex; (11)Pfizer's and our strategy and business plans concerning the continued development and commercialization of CDX-110; (12) Celldex's expectations regarding its technological capabilities and expanding its focus to broader markets for vaccines; (13) changes in existing and potential relationships with corporate collaborators; (14) the availability, cost, delivery and quality of clinical and commercial grade materials produced at Celldex's own manufacturing facility or supplied by contract manufacturers and partners; (15) the timing, cost and uncertainty of obtaining regulatory approvals; (16) Celldex's ability to develop and commercialize products before competitors that are superior to the alternatives developed by such competitors; (17) Celldex's ability to retain certain members of management;(18) Celldex's expectations regarding research and development expenses and general and administrative expenses; (19) Celldex's expectations regarding cash balances, capital requirements, anticipated royalty payments, revenues and expenses, including infrastructure expenses; (20) the ability to obtain substantial additional funding; (21) Celldex's belief regarding the validity of our patents and potential litigation; and (22) certain other factors that might cause Celldex'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 of Financial Condition and Results of Operations" in each of Celldex's Annual Report on Form 10-K, its current Reports on Form 8-K, as well as those described in Celldex'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 Celldex does not promise to update any forward-looking statements to reflect changes in underlying assumptions or factors, new information, future events or other changes.