Form 8-K

 

 

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 21, 2017

 

 

CytoDyn Inc.

(Exact name of registrant as specified in its charter)

 

 

 

Delaware   000-49908   75-3056237

(State or other jurisdiction

of incorporation)

  

(SEC

File Number)

  

(I.R.S. Employer

Identification No.)

1111 Main Street, Suite 660

Vancouver, Washington

   98660
(Address of principal executive offices)   (Zip Code)

Registrant’s 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):

 

☐ 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))

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 Regulation FD Disclosure.

On August 21, 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.

Item 8.01. Other Events

On August 21, 2017, the Company announced that it has enrolled 34 patients in its pivotal Phase 2b/3 trial of PRO 140 in combination with antiretroviral therapy (ART) in HIV-infected patients. Thirty-three of the enrolled patients have finished the one-week efficacy endpoint of the study and eleven patients have completed the full 25-week protocol with undetectable viral loads. Ten patients are currently in a rollover study after completing the 25-week trial. The U.S. Food and Drug Administration has set a meeting on October 17, 2017, to discuss the next steps in the Company’s efforts towards the analysis of primary efficacy endpoint and filing of a Biologics License Application for PRO 140.

Item 9.01. Financial Statements and Exhibits.

 

(d)   

Exhibit

No.

   

Description.

   99.1    Press Release, dated August 21, 2017

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.

 

    CytoDyn Inc.
August 21, 2017     By:  

/s/ Michael D. Mulholland

    Name:   Michael D. Mulholland
    Title:   Chief Financial Officer

Exhibit Index

 

Exhibit

No.

   

Description.

99.1    Press Release, dated August 21, 2017.