CytoDyn Inc 8-K, filed Jun 15, 2021
CytoDyn Inc. (CYDY)
About this 8-K
CytoDyn Inc filed this 8-K on June 15, 2021, reporting on events of June 9, 2021.
Items reported
- Item 1.02: Ended a material agreement
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, DC 20549
FORM
Current Report
Pursuant to Section 13 or 15(d)
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Date of Report (Date of earliest event reported): June 15, 2021 (
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| Item 1.02. | Termination of Material Definitive Agreement. |
Effective June 9, 2021, CytoDyn Inc. (the “Company”) and American Regent, Inc. (“American Regent”), mutually agreed to terminate the Distribution and Supply Agreement between the parties dated July 2, 2020 (the “Agreement”). The Agreement had appointed American Regent as the exclusive distributor in the United States of the Company’s leronlimab (PRO140) drug for the treatment of COVID-19 in the United States, effective upon, among other things, regulatory approval of a biologics license application for leronlimab by the U.S. Food and Drug Administration (“FDA”) for the treatment of COVID-19. The parties determined to terminate the agreement due to the Company’s failure to meet its primary and secondary endpoints under the FDA’s guidelines for the Company’s two COVID-19 trials for the treatment of mild-to-moderate and severe-to-critical COVID-19 populations. As a result of the termination, there is no ongoing material relationship between the parties and no payments or penalties are due under the Agreement. The Company is continuing to evaluate the efficacy of leronlimab for the treatment of COVID-19 through newly designed protocols for clinical trials.
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned thereunto duly authorized.
| CYTODYN INC. | ||||||
| Date: June 15, 2021 | By: | /s/ Antonio Migliarese | ||||
| Antonio Migliarese Chief Financial Officer | ||||||