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 | | Press Release 23 August 2018 07:00 a.m. CEST Regulated Information |
For more information, please contact:
Celyad
Christian Homsy, CEO and Patrick Jeanmart CFO
Nicolas Van Hoecke, Director, Investor Relations & Communications -T: +32(0) 10 39 41 84 -investors@celyad.com
For Belgium: Comfi
Sabine Leclercq -T.: +32 (0)2 290 90 90 -celyad@comfi.be
For France: NewCap
Pierre Laurent and Nicolas Mérigeau -T: + 33(0)1 44 71 94 94 -celyad@newcap.eu
For the U.S.: LifeSci Advisors
Daniel Ferry -T.: +1 (617) 535 7746 -daniel@lifesciadvisors.com
Public Relations: Allison Blum -T:+1 (646) 627 8383 -allison@lifescipublicrelations.com
Forward-looking statements
This release may contain forward-looking statements, including statements regarding the safety and efficacy ofCYAD-01 and the new mAb manufacturing method used to manufacture this drug product candidate; statements concerning the ongoing and planned clinical development ofCYAD-01, including the timing of data readouts and presentations; the clinical and commercial potential ofCYAD-01 and the adequacy of Celyad’s financial resources; Celyad’s financial condition, results of operation and business outlook; and Celyad’s expected cash burn. Forward-looking statements may involve known and unknown risks, uncertainties and other factors which might cause actual results, financial condition and liquidity, performance or achievements of Celyad, or industry results, to differ materially from those expressed or implied by such forward-looking statements. In particular it should be noted that the interim data summarized above are preliminary in nature. There is limited data concerning safety and clinical activity following treatment with theCYAD-01 drug product candidate. These results may not be repeated or observed in ongoing or future studies involving theCYAD-01 drug product candidate. These forward-looking statements are further qualified by important factors and risks, which could cause actual results to differ materially from those in the forward-looking statements, including statements about: the initiation, timing, progress and results of our preclinical studies and clinical trials, and our research and development programs; our ability to advance drug product candidates into, and successfully complete, clinical trials; our ability to successfully manufacture drug product for our clinical trials, including with our new mAb manufacturing process and with respect to manufacturing drug product with the desired number of T cells under our clinical trial protocols; our reliance on the success of our drug product candidates, including our dependence on the regulatory approval ofCYAD-01 in the United States and Europe and subsequent commercial success ofCYAD-01, both of which may never occur; the timing or likelihood of regulatory filings and approvals; our ability to develop sales and marketing capabilities; the commercialization of our drug product candidates, if approved; the pricing and reimbursement of our drug product candidates, if approved; the implementation of our business model, strategic plans for our business, drug product candidates and technology; the scope of protection we are able to establish and maintain for intellectual property rights covering our drug product candidates and technology; our ability to operate our business without infringing, misappropriating or otherwise violating the intellectual property rights and proprietary technology of third parties; cost associated with enforcing or defending intellectual property infringement, misappropriation or violation; product liability; and other claims; regulatory development in the United States, the European Union, and other jurisdictions; estimates of our expenses, future revenues, capital requirements and our needs for additional financing; the potential benefits of strategic collaboration agreements and our ability to enter into strategic arrangements; our ability to maintain and establish collaborations or obtain additional grant funding; the rate and degree of market acceptance of our drug product candidates, if approved; our financial performance; developments relating to our competitors and our industry, including competing therapies and statements regarding future revenue, hiring plans, expenses, capital expenditures, capital requirements and share performance. A further list and description of these risks, uncertainties and other risks
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