Company Is Successfully Executing on Multi-Faceted Strategy to Bring Leronlimab to Market
Activist Group Offers No New Compelling Strategic Direction and its "Plan" Includes Numerous Misrepresentations and Misleading Statements
Activist Group’s Continued Attempts to Link CytoDyn to IncellDx Are Troubling, Given Connections Between IncellDx and Group’s Nominees
Shareholders Do Not Need to Take Any Action at this Time
CytoDyn Inc. (OTCQB: CYDY) ("CytoDyn" or the "Company"), a late-stage biotechnology company developing leronlimab, a CCR5 antagonist with the potential for multiple therapeutic indications, today responded to the "plan" put forward by an activist group led by Paul Rosenbaum and Bruce Patterson (the "Rosenbaum/Patterson Group" or the "Activist Group"):
CytoDyn is highly focused on the expeditious development of leronlimab to help patients with critical needs. Clinical development of any product is a multi-year endeavor. Within this context, the Company has acted as quickly as possible – bringing leronlimab from the Phase 2b stage to successfully completing a pivotal Phase 3 (p=0.0032) in seven years, which was significantly faster than leronlimab’s progress with its prior owner. CytoDyn is exploring several different indications for leronlimab. These include COVID-19 critical and severe hospitalized patients as well as long-haulers, HIV and 22 different cancer types. The Company strongly believes in the drug’s potential – especially given that it is variant agnostic when it comes to treating COVID-19.
The Activist Group’s missive is not a "plan"; it appears to be a misguided and misleading attempt to discredit the significant efforts of CytoDyn to bring leronlimab’s lifesaving potential to market to help patients and drive value for shareholders. The success of these efforts is clearly demonstrated by the increasingly long list of positive developments that CytoDyn has announced recently, including the clearance from Brazil’s regulatory authority, ANVISA (Agência Nacional de Vigilância Sanitária), to begin an additional Phase 3 CD16 clinical trial of leronlimab with IV treatment, which the Company believes will have an enormous advantage over treatment via subcutaneous (SQ) injections. CytoDyn will continue to work tirelessly towards approvals for leronlimab and are laser focused on doing what is best for all shareholders.
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