8-K

CYTODYN INC.

Date: June 15, 2021

/s/ Antonio Migliarese

Antonio Migliarese

Chief Financial Officer

0001193125-21-191253.txt : 20210615 0001193125-21-191253.hdr.sgml : 20210615 20210615170054 ACCESSION NUMBER: 0001193125-21-191253 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 12 CONFORMED PERIOD OF REPORT: 20210609 ITEM INFORMATION: Termination of a Material Definitive Agreement FILED AS OF DATE: 20210615 DATE AS OF CHANGE: 20210615 FILER: COMPANY DATA: COMPANY CONFORMED NAME: CytoDyn Inc. CENTRAL INDEX KEY: 0001175680 STANDARD INDUSTRIAL CLASSIFICATION: PHARMACEUTICAL PREPARATIONS [2834] IRS NUMBER: 753056237 STATE OF INCORPORATION: DE FISCAL YEAR END: 0531 FILING VALUES: FORM TYPE: 8-K SEC ACT: 1934 Act SEC FILE NUMBER: 000-49908 FILM NUMBER: 211019262 BUSINESS ADDRESS: STREET 1: 1111 MAIN STREET, SUITE 660 CITY: VANCOUVER STATE: WA ZIP: 98660 BUSINESS PHONE: 360-980-8524 MAIL ADDRESS: STREET 1: 1111 MAIN STREET, SUITE 660 CITY: VANCOUVER STATE: WA ZIP: 98660 FORMER COMPANY: FORMER CONFORMED NAME: CYTODYN INC DATE OF NAME CHANGE: 20031114 FORMER COMPANY: FORMER CONFORMED NAME: REXRAY CORP DATE OF NAME CHANGE: 20020617 8-K 1 d180902d8k.htm 8-K 8-K

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, DC 20549

FORM 8-K

Current Report

Pursuant to Section 13 or 15(d)

of the Securities Exchange Act

Date of Report (Date of earliest event reported): June 15, 2021 (June 9, 2021)

CytoDyn Inc.

(Exact name of registrant as specified in its charter)

Delaware

000-49908

83-1887078

(State or other jurisdiction

of incorporation or organization)

(Commission

File Number)

(I.R.S. Employer

Identification No.)

1111 Main Street, Suite 660

Vancouver, Washington 98660

(Address of principal executive offices, including zip code)

(360) 980-8524

(Registrant’s telephone number, including area code)

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:

☐	Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

☐	Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

☐	Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

☐	Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

Securities registered pursuant to Section 12(b) of the Act:

Title of each class

Trading

Symbol(s)

Name of each exchange

on which registered

None.

Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).

Emerging growth company ☐

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐

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.

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Document and Entity Information	Jun. 09, 2021
Cover [Abstract]
Amendment Flag	false
Entity Central Index Key	0001175680
Document Type	8-K
Document Period End Date	Jun. 09, 2021
Entity Registrant Name	CytoDyn Inc.
Entity Incorporation State Country Code	DE
Entity File Number	000-49908
Entity Tax Identification Number	83-1887078
Entity Address, Address Line One	1111 Main Street
Entity Address, Address Line Two	Suite 660
Entity Address, City or Town	Vancouver
Entity Address, State or Province	WA
Entity Address, Postal Zip Code	98660
City Area Code	(360)
Local Phone Number	980-8524
Written Communications	false
Soliciting Material	false
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Pre Commencement Issuer Tender Offer	false
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