Current Report Filing (8-k)
October 28 2022 - 05:16PM
Edgar (US Regulatory)
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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): October 28,
2022
CytoDyn Inc.
(Exact name of registrant as specified
in its charter)
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Delaware
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000-49908
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83-1887078
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(State or other jurisdiction of
incorporation or organization)
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(Commission File Number)
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(I.R.S. Employer Identification
No.)
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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:
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☐
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Written communications pursuant to Rule 425 under the Securities
Act (17 CFR 230.425)
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☐
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Soliciting material pursuant to Rule 14a-12 under the Exchange Act
(17 CFR 240.14a-12)
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Pre-commencement communications pursuant to Rule 14d-2(b) under the
Exchange Act (17 CFR 240.14d-2(b))
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Pre-commencement communications pursuant to Rule 13e-4(c) under the
Exchange Act (17 CFR 240.13e-4(c))
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Securities registered pursuant to Section 12(b) of the Act:
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Title of each class
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Trading Symbol(s)
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Name of each exchange on which
registered
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None
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None
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None
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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.
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Item
7.01 Regulation FD Disclosure.
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On October 28, 2022, CytoDyn
Inc. (the “Company”) issued a press release describing its
voluntary withdrawal of its Biologics License Application (“BLA”)
and plans for the future study of leronlimab in HIV-related,
non-alcoholic steatohepatitis (“NASH”), and oncology
indications.
The Company will host a
conference call on Monday, October 31, 2022, at 5:30 a.m. Pacific
Time to discuss this regulatory and clinical update. A copy of the
press release is being filed as Exhibit 99.1 and incorporated in
this Item by reference.
On October 28, 2022, the
Company issued a press release announcing the Company had
voluntarily withdrawn the pending BLA for leronlimab as a
combination therapy in persons living with HIV with resistance to
highly active antiretroviral therapy (“HAART”) in the HIV
multi-drug resistant population (“HIV-MDR”).
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Item
9.01 Financial Statements And
Exhibits.
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(d) Exhibits.
** Furnished, not
filed.
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.
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CYTODYN INC.
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Date: October 28, 2022
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By
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/s/ Antonio Migliarese
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Antonio Migliarese
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Chief Financial Officer
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CytoDyn (QB) (USOTC:CYDY)
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