CytoDyn Comments on Rosenbaum/Patterson Activist Group “Plan”
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.
Readers of the Activist Group’s “plan” should consider the following:
The Activist Group Offers No New Compelling Strategic Direction with Respect to Cancer Therapy Approval
- CytoDyn is currently working with some of the top oncological opinion leaders in the world from well-respected academic institutions. These experts will assist CytoDyn in determining the appropriate targets and the most efficient path to Breakthrough Therapy designation and approval of leronlimab.1
- CytoDyn has already stated publicly that it believes leronlimab has a potential synergistic effect with PD-L1/PD-1 inhibitors, PARP inhibitors, antibody-drug conjugates, and chemotherapy. However, since the first cancer indication with mTNBC has shown what the Company believes to be very strong results, CytoDyn will focus obtaining Breakthrough Therapy designation as the fastest path to approval. Approval of leronlimab in combination with other therapies will take at least another two to three years – but if the Company receives approval for mTNBC, then label expansion would be much faster for any additional cancer indication.2
- CytoDyn recently signed a contract with a top oncology academic institution to evaluate the anti-tumor effect of leronlimab and checkpoint inhibitors.3
- The Company has already publicly discussed the potential value of leronlimab with combination therapy. Further, current management has first-hand experience with the potential of leronlimab in monotherapy for patients who respond to leronlimab single agent therapy and in combination therapy when other treatments have failed – or when a patient is intolerant of certain standard of care regimens and therefore their background therapy is their last recourse.4
- Regarding pharmaceutical partners, CytoDyn has been in contact with potential partners both domestically and internationally. The main catalyst for partnerships is data, which CytoDyn did not have previously. The Company now has that data and is evaluating options including partnerships with academic institutions and major pharmaceutical companies.5
The Activist Group’s Continued Attempts to Link CytoDyn to IncellDx Are Troubling
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