Our Business Strategy
We seek to develop and commercialize Locilex ® (pexiganan cream 0.8%) either directly or through one or more potential partnerships. In the light of the disappointing outcomes of our OneStep-1 and OneStep-2 Phase 3 clincial trials of Locilex ® for the treatment of patients with mild infections of diabetic foot ulcers, we have identified and assessed a broad range of strategic options, culminating in our decision to enter into the Merger Agreement with PLx Pharma.
• Restart clinical and regulatory development of Locilex ® in one or more new clinical indications/Proposed Merger with PLx Pharma. Based upon the advice of our research and development consultants, in order to maintain a viable drug development strategy for Locilex ® , we need to identify one or more new clinical indications potentially well served by Locilex ® and restart drug development activities in at least one new indication. Based on the clinicial evidence from the recently completed OneStep Phase 3 clinical trials, our research and development team has been unable to identify an appropriate clinical indication that we may target with Locilex ® for further drug development activities. If identified, a new clinical and regulatory pathway for Locilex ® may very well involve restarting with Phase 1 clinical trials and involve significant resources and risk to get back to Phase 3 clinical trials and beyond. Accordingly, we decided to enter into an agreement with respect to the Proposed Merger with PLx Pharma. Assuming the Proposed Merger is consummated as planned in the second quarter of 2017, the combined company will focus its development on PLx Pharma’s product pipeline.
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• Seek value for Locilex ® either directly through a restart in a new clinical indication or through one or more partnerships. Whether or not our Proposed Merger with PLx Pharma is completed as planned, we will continue to preserve the Locilex ® asset including by maintaining our patent portfolio and preparing and submitting all required regulatory submissions while we evaluate whether or not to develop Locilex ® ourselves or through one or more potential future partnerships with third parties.
Because of the high risk nature of restarting clinical development in a yet-to-be-identified clinical indication within which no clinical trials have been performed to date using Locilex ® and the high cost of this endeavor, our board of directors and management team have concluded that the Proposed Merger with PLx Pharma is a more attractive alternative to preserve and recapture stockholder value.
