CytoDyn Inc. Form 8-K (Sept. 22, 2021)

Summary

Form 8-K current report of CytoDyn Inc. dated September 22, 2021. Under Item 8.01 it reports a press release announcing clearance from Brazil's regulatory authority, ANVISA, to begin a pivotal Phase 3 trial in critically ill COVID-19 patients with intravenous administration of four doses of 700 mg/week. The press release is furnished as Exhibit 99.1. The report is signed by Antonio Migliarese, Chief Financial Officer.

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Full text

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): September 22, 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 | 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.

On September 22, 2021, CytoDyn Inc. (the “Company”) issued a press release announcing that the Company has received clearance from Brazil’s regulatory authority, ANVISA (Agência Nacional de Vigilância Sanitária), to commence a pivotal Phase 3 trial in critically ill COVID-19 patients with IV administration of four doses (700 mg/week).

A copy of the press release is included as Exhibit 99.1 to this Report and is incorporated herein by reference.

Item 9.01 | Financial Statements and Exhibits

(d) Exhibits

99.1 | Press Release, dated September 22, 2021
104 | Cover Page Interactive Data File (formatted as inline XBRL)

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 hereunto duly authorized.

Date: September 22, 2021 | CYTODYN INC.
By: | /s/ Antonio Migliarese
Antonio Migliarese
Chief Financial Officer

File and source

File

SEC_CYDY_8-K_filed2021-09-22_0001193125-21-279389.htm

Size

23,708 bytes

SHA-256

45a303107bb2b446f89e57a9d56308b5bfdc2b5db974836a65cb5417214814bf

Our copy

SEC_CYDY_8-K_filed2021-09-22_0001193125-21-279389.htm

Original

www.sec.gov

Exhibits

Exhibit 99.1: CytoDyn Inc., "CytoDyn Receives Clearance from Brazil's FDA (ANVISA) to Commence a Pivotal Phase 3 Trial in Critically Ill COVID-19 Patients"