Safe Harbor Statement under the Private Securities Litigation Reform Act of 1995:
The information provided on this site includes information which are “forward-looking statements” made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995, including those related to the Company’s strategic focus and the future development and commercialization (by Celldex and others) of rindopepimut (CDX-110), CDX-011, CDX-1135, CDX-1401, CDX-1127, CDX-301, Belinostat and other products. These forward-looking statements are subject to a variety of risks and uncertainties and reflect Celldex's current knowledge, assumptions, judgment and expectations regarding future events and financial performance. You can identify forward-looking statements by the use of the words "may," "will," "can," "anticipate," "assume," "should," "indicate," "would," "believe," "comtemplate," "expect," "seek," "estimate," "continue," "plan," "point to," "project," "predict," "could," "intend," "target," "potential," and other similar words and expressions which predict or indicate future events and trends to and which do not relate to historical matters. You should not rely on forward-looking statements, because they involve known and unknown risks, uncertainties and other factors, some of which are beyond the control of the Company. These risks, uncertainties and other factors may cause the actual results, performance or achievements of the Company to be materially different from the anticipated future results, performance or achievements expressed or implied by the forward-looking statements.
Some of the factors that might cause these differences include, but are not limited to: (1) our limited cash reserves and our ability to obtain additional capital on acceptable terms, or at all, including the additional capital which will be necessary to complete the clinical trials that we have initiated or plan to initiate; (2) the ability to adopt Celldex’s APC Targeting Technology™ to develop new, safe and effective vaccines against oncology and infectious disease indications; (3) the ability to successfully complete product research and further development, including animal, preclinical and clinical studies, and commercialization of rindopepimut (CDX-110), CDX-1401, CDX-011, CDX-1135, CDX-1127, CDX-301 and other products and Celldex’s expectations regarding market growth for those drug candidates; (4) our ability to manage multiple clinical trials for a variety of drug candidates at different stages of development, including our Phase 3 trial for rindopepimut; (5) the cost, timing, scope and results of ongoing safety and efficacy trials of rindopepimut (CDX-110), CDX-1401, CDX-011, CDX-1135, CDX-1127, CDX-301 and other preclinical and clinical testing; (6) our ability to fund and complete the development and commercialization of rindopepimut for North America internally and to find a strategic partner to commercialize rindopepimut outside of North America; (7) the ability to negotiate strategic partnerships, where appropriate, for our lead programs, including CDX-011 and CDX-1127, as well as for our non-core programs; (8) the strategies and business plans of our partners, such as GlaxoSmithKline’s plans with respect to Rotarix® and Vaccine Technologies’ plans concerning the CholeraGarde® (Peru-15) and ETEC E. coli vaccines, which are not within our control, and our ability to maintain strong, mutually beneficial relationships with these partners; (9) Celldex’s expectations regarding its technological capabilities and expanding its focus to broader markets for vaccines; (10) 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; (11) changes in existing and potential relationships with corporate collaborators; (12) the availability, cost, delivery and quality of clinical management services provided by our clinical research organization partners; (13) the timing, cost and uncertainty of obtaining regulatory approvals for our product candidates; (14) Celldex’s ability to develop and commercialize products before competitors that are superior to the alternatives developed by such competitors; (15) Celldex’s ability to retain certain members of management; (16) Celldex’s expectations regarding research and development expenses and general and administrative expenses; (17) Celldex’s expectations regarding cash balances, capital requirements, anticipated royalty payments (including those from Paul Royalty Fund), revenues and expenses, including infrastructure expenses; (18) the ability to obtain substantial additional funding; (19) Celldex’s belief regarding the validity of our patents and our ability to avoid potential intellectual property litigation, which can be costly and divert management time and attention; and (20) 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.
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