Current Report Filing (8-k)
August 09 2017 - 4:05PM
Edgar (US Regulatory)
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): August 9, 2017
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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75-3056237
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(State or other jurisdiction
of incorporation)
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(SEC
File Number)
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(I.R.S. Employer
Identification No.)
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1111 Main Street, Suite 660
Vancouver, Washington
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98660
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(Address of principal executive offices)
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(Zip Code)
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Registrants telephone number, including area code: (360) 980-8524
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 (see General Instruction A.2. below):
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Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
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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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Indicate by check mark whether the registrant is an emerging growth company as defined in 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
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Regulation FD Disclosure.
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On August 9, 2017, CytoDyn Inc. (the Company) issued a press
release relating to the announcement described in Item 8.01 below, a copy of which is furnished as Exhibit 99.1 to this
Form 8-K.
On August 9, 2017, the Company announced that 33 patients are currently enrolled in
its pivotal Phase 2b/3 combination therapy trial. The Company has been in ongoing dialogue with the U.S. Food and Drug Administration (the FDA) regarding the number of patients enrolled in the trial. Patient enrollment will remain
open in the trial until the Company holds a teleconference meeting with the FDA to discuss patient enrollment and analysis of data from the trial. The meeting is expected to be held in coming weeks.
The Companys pivotal Phase 2b/3 trial combination trial is evaluating PRO 140 with current standard of care antiretroviral therapy
(ART). The trial protocol requires enrollment of 30 patients for the purpose of assessing the trials primary efficacy endpoint, which is reached at one week following initial treatment with PRO 140. The safety portion of the
Phase 2b/3 trial continues for an additional 24 weeks. The Company expects to complete the clinical portion of its first Biological License Application (BLA) submission during the first half of 2018.
The Company is also conducting a 300-patient Phase 2b/3 trial with PRO 140 as a single agent to replace the current standard of care ART and
enrollment currently exceeds 100 patients.
Item 9.01.
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Financial Statements and Exhibits.
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(d)
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Exhibit
No.
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Description.
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99.1
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Press Release, dated August 9, 2017
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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
hereunto duly authorized.
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CytoDyn Inc.
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August 9, 2017
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By:
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/s/ Michael D. Mulholland
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Name:
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Michael D. Mulholland
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Title:
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Chief Financial Officer
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Exhibit Index
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Exhibit
No.
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Description.
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99.1
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Press Release, dated August 9, 2017.
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