Proposed Re-Draft of Today's Press Release Belo

Proposed Re-Draft of Today's Press Release

Below is an email sent by me today to Dr. Pourhassan suggesting a proposed re-write of today's press release:

Dr. Pourhassan:

Cytodyn’s press releases, such as that issued today, are vague, ambiguous, and very difficult to interpret.

Below is a suggestion as to how today’s press release could have been written more clearly:

First Two Patients Enrolled in FDA Suggested Randomized Phase 2, COVID-19 Trial For Leronlimab;

15 Severely Ill COVID-19 Patients Have Been Treated With Leronlimab Under Emergency IND With Results Now Available for the First Eight;

Four Out of Eight Patients Treated Under Emergency IND Have Extubated;

Results For the Remaining Seven Emergency IND Patients Are Expected Shortly, and Will be Provided to the FDA.


VANCOUVER, Washington, April 06, 2020 (GLOBE NEWSWIRE) -- CytoDyn Inc. (OTC.QB: CYDY), (“CytoDyn” or the “Company", a late-stage biotechnology company developing Leronlimab (PRO 140), a CCR5 antagonist with the potential for multiple therapeutic indications, announced today that the first two COVID-19 patients have been treated with Leronlimab under the Company’s Phase 2 randomized clinical trial, which is for patients with mild-to-moderate indications. The Company anticipates that enrollment of additional patients will accelerate this week at _____clinical sites located throughout the United States including New York City, San Francisco, Detroit, New Orleans, and Seattle. [location of sites to be verified by Cytodyn]

In addition, Leronlimab has been administered to 15 severely ill COVID-19 patients at four hospitals under an emergency investigational new drug (EIND) program approved by the FDA. 10 of these 15 patients were treated at a leading medical center in the New York City area, while five other patients were treated at three other hospitals.

CytoDyn also anticipates initiating a second clinical trial this week for severely ill COVID-19 patients. This second trial, which is an FDA approved Phase 2b/3 trial, will enroll 342 patients, and is double-blinded with a 2:1 ratio (drug to placebo ratio). Patients enrolled in this trial are expected to be administered Leronlimab for two weeks, with the primary endpoint being the mortality rate at 14 days. The Company will perform an interim analysis on the data from 50 patients following two weeks of Leronlimab treatment.

Bruce Patterson, M.D., Chief Executive Officer and founder of IncellDx, a diagnostic partner and advisor to CytoDyn, commented, “We are encouraged by the positive results demonstrated with Leronlimab in the New York patients. Our team is working hard to distribute Leronlimab to multiple clinical sites to initiate therapy in patients with severe COVID-19 disease. While every patient is experiencing different comorbidities, we are seeing similar clinical responses, which we believe is a reflection of Leronlimab’s mechanism of action.”

Nader Pourhassan, Ph.D., President and Chief Executive Officer of CytoDyn, said, “Our partnership with the New York medical team and now other hospitals has been exemplary. We are collaborating in every aspect to deliver Leronlimab to patients in order to provide proof of concept as soon as possible. The outstanding coordination among the physicians, the hospital administrators, the FDA, and our team, will hopefully help mitigate the deleterious effects from this pandemic should we prove Leronlimab as a solution. The lead physician in New York is a true medical hero, who deserves to be recognized for his contribution to humanity in the pandemic of COVID-19. We are very hopeful of sending the day three and day seven results of the first ten EIND patients to the FDA by the end of this week.”

Thank you,

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