Date:12/9/2009

act on the Company and its ability to continue, or if not obtained in a timely manner, may result in the Company's having to discontinue or delay one or more of its product development programs or other initiatives; the risk that the FDA is not bound by its pre-IND meetings and the need for further regulatory approvals, which may not be obtained in a timely manner or at all; uncertainty whether any of the timelines mentioned in this press release will be achieved; Helix's dependence on its contract research organizations, contract manufacturing organizations, clinical trial consultants, collaborative research consultants, regulatory affairs advisors, and other service providers, whose performance and interdependence can critically affect the Company's performance and the achievement of its milestones; uncertainty whether any of the clinical trials referred to in this news release will be approved, initiated or completed or will achieve expected results; the need for additional clinical trials, the occurrence and success of which cannot be assured; product liability and insurance risks; research and development risks, including the possibility that further challenges may arise in connection with the manufacturing of L-DOS47 or Topical Interferon Alpha-2b, or in connection with the pharmacokinetic study; the risk of obtaining negative findings or factors that may become apparent during the course of research or development, including during the course of clinical trials, which may result in the discontinuation or delay of the research or development projects; intellectual property risks, including without limitation, the risk that three patents for Topical Interferon Alpha-2b will expire in 2013 and no additional patent may be issued, that patent applications may not result in issued patents, that issued patents may be circumvented or struck down, and the risk of potential claims of infringement by the Company of third party intellectual property rights; the risk tha
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