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

Summary

A Form 8-K current report of CytoDyn Inc. dated July 22, 2021 and signed by Antonio Migliarese, Chief Financial Officer. Item 7.01 reports a July 19, 2021 press release announcing preliminary results from trials and compassionate use with a total of 30 metastatic triple-negative breast cancer patients treated with leronlimab. It also reports that on July 22, 2021 company management discussed a summary of preliminary data from the breast cancer trials and a COVID-19 long-haulers trial during an investment community webcast. The press release is Exhibit 99.1 and the Investor Presentation is Exhibit 99.2.

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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

Date of Report (Date of earliest event reported): July 22, 2021 ( July 19, 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 7.01. | Regulation FD Disclosure.

On July 19, 2021, CytoDyn Inc. (the “Company”), issued a press release announcing the preliminary results from its Phase 1b/2 trials and compassionate use with a total of 30 metastatic triple-negative breast cancer patients treated with leronlimab. A copy of the press release is furnished as Exhibit 99.1 to this Current Report on Form 8-K. On July 22, 2021, Company management, during a previously announced investment community webcast, discussed a summary of the preliminary data from the breast cancer trials and COVID-19 long-haulers trial, including a presentation of the empirical results from each, which are included in an Investor Presentation furnished as Exhibit 99.2 to this Current Report on Form 8-K.

Item 9.01 | Financial Statements and Exhibits.

(d) Exhibits:

The press release and Investor Presentation described in Item 7.01 are furnished with this report as Exhibit 99.1 and Exhibit 99.2, respectively.

EXHIBIT INDEX

Exhibit | Description
99.1 | Press release dated July 19, 2021
99.2 | Investor Presentation dated July 22, 2021
104 | Cover Page Interactive Data File (embedded within the Inline XBRL document)

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: July 22, 2021 | By: | /s/ Antonio Migliarese
Antonio Migliarese
Chief Financial Officer

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