CytoDyn Inc. Form 8-K (March 30, 2022)

Summary

Form 8-K current report of CytoDyn Inc. dated March 30, 2022, filed under Item 8.01 (Other Events). It reports that the U.S. Food and Drug Administration recently placed a full clinical hold on the company's COVID-19 program and a partial clinical hold on its HIV program in the United States. The company had already paused its COVID-19 trials in Brazil. Under the partial hold no HIV clinical studies may be initiated or resumed, and patients enrolled in the extension trials will be moved to other available therapeutics. Under the full hold no new COVID-19 clinical studies may be initiated until the hold is resolved. The report is signed by Antonio Migliarese.

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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 of 1934

Date of Report (Date of earliest event reported): March 30, 2022

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 | None | 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 8.01 | Other Events.

CytoDyn Inc. (the “Company”) reported today that the U.S. Food and Drug Administration (the “FDA”) recently placed a full clinical hold on its COVID-19 program and a partial clinical hold on its HIV program in the United States. The Company had previously paused its COVID-19 trials in Brazil.

Under the partial clinical hold on the Company’s HIV program, no clinical studies may be initiated or resumed until the partial clinical hold has been resolved. As a result of the partial clinical hold on the HIV program, patients currently enrolled in the extension trials will be transitioned to other available therapeutics. Under the full clinical hold on the COVID-19 program, no new clinical studies may be initiated until the clinical hold is resolved.

SIGNATURE

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: March 30, 2022 | By | /s/ Antonio Migliarese
Antonio Migliarese Chief Financial Officer and Interim President

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