Cytodyn Inc (CYDY)

[JPG77]

CytoDyn Announces Favorable Ruling Granting Injunction Against Former CRO

Court order requires CRO to provide CytoDyn full access to all its clinical trial data

VANCOUVER, Wash.--(BUSINESS WIRE)-- 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 announced that the U.S. District Court for the District of Maryland has granted CytoDyn’s previously-announced motion for a preliminary injunction against NSF International, Inc. and its subsidiary Amarex Clinical Research (“Amarex”), the Company’s former Contract Research Organization (“CRO”).

Over the past eight years, Amarex provided clinical trial management services to CytoDyn and managed numerous clinical trials. The Company’s complaint alleged that Amarex failed to perform its obligations under the master services agreement and work orders that governed the relationship between the parties. As a result, the Company suffered substantial damages.

The Court concluded that the Company was likely to succeed on its claims that Amarex breached the various agreements with CytoDyn, and therefore entered an injunction requiring Amarex to provide CytoDyn access to databases of its clinical trial data that Amarex has been wrongfully withholding. Specifically, the Court’s injunction requires Amarex to provide CytoDyn full access to the electronic data capture (“EDC”) and all related data. Further, it requires Amarex to cooperate with an independent audit to begin promptly after February 1, 2022. Additionally, the order is subject to the Company posting a $6.5 million bond no later than January 14, 2022.

Nader Pourhassan, Ph.D., CytoDyn’s President and Chief Executive Officer, commented, “We are pleased with the Court’s ruling and are focused on the positive momentum of our pipeline. It is gratifying to see that Amarex will be held accountable for its numerous shortcomings in delaying the potential of the availability of leronlimab to thousands of patients for multiple indications. By doing so, we believe they also harmed our shareholders. Upon completion of our court-granted audit, if any damages are discovered which are due to negligence on behalf of Amarex, we will aggressively pursue all and any legal action.”

https://www.cytodyn.com/newsroom/press-releases/detail/591/cytodyn-announces-favorable-ruling-granting-injunction