SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, DC 20549
PURSUANT TO SECTION 13 OR 15(d)
OF THE SECURITIES EXCHANGE ACT OF 1934
Date of Report (Date of earliest event reported): June 22, 2018
(Exact name of registrant as specified in its charter)
(State or other jurisdiction
1111 Main Street, Suite 660
|(Address of principal executive offices)||(Zip Code)|
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):
|☐||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 June 22, 2018, CytoDyn Inc., a Delaware corporation (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 June 22, 2018, the Company announced that it had a meeting with the U.S. Food and Drug Administration (the FDA) regarding the Companys planned Biologics License Application (BLA) for PRO 140. Based on FDA feedback, the Company will continue to gather safety and efficacy data from its ongoing monotherapy HIV clinical trials to support the BLA submission. The FDA pointed to various potential review issues that the Company believes it can adequately address in the BLA. The agency agreed that the safety portion of the filings should include data from patients treated with PRO 140 and followed for a minimum of 24 weeks, which the Company can accumulate from any of the Companys three ongoing HIV clinical trials, two of which are monotherapy trials. The Company anticipates that its BLA filings may start as early as the end of 2018, and that the FDA review process will start when the full BLA submission is completed and the FDA has accepted the BLA for review.
This Current Report on Form 8-K contains certain forward-looking statements that involve risks, uncertainties and assumptions that are difficult to predict, including statements regarding the Companys current and proposed trials and studies and their enrollment, results, costs and completion. Words and expressions reflecting optimism, satisfaction or disappointment with current prospects, as well as words such as believes, hopes, intends, estimates, expects, projects, plans, anticipates and variations thereof, or the use of future tense, identify forward-looking statements, but their absence does not mean that a statement is not forward-looking. The Companys forward-looking statements are not guarantees of performance and actual results could differ materially from those contained in or expressed by such statements. In evaluating all such statements, the Company urges investors to specifically consider the various risk factors identified in the Companys Form 10-K for the fiscal year ended May 31, 2017 in the section titled Risk Factors in Part I, Item 1A, as supplemented by its Form 10-Q for the fiscal quarter ended February 28, 2018, any of which could cause actual results to differ materially from those indicated by the Companys forward-looking statements.
The Companys forward-looking statements reflect its current views with respect to future events and are based on currently available financial, economic, scientific, and competitive data and information on current business plans. Investors should not place undue reliance on the Companys forward-looking statements, which are subject to risks and uncertainties relating to, among other things: (i) the sufficiency of the Companys cash position and the Companys ongoing ability to raise additional capital to fund its operations, (ii) the Companys ability to complete its Phase 2b/3 pivotal combination therapy trial for PRO 140 (CD02) and to meet the FDAs requirements with respect to safety and efficacy to support the filing of a Biologics License Application, (iii) the Companys ability to meet its debt obligations, if any, (iv) the Companys ability to identify patients to enroll in its clinical trials in a timely fashion, (v) the Companys ability to achieve approval of a marketable product, (vi) design, implementation and conduct of clinical trials, (vii) the results of the Companys clinical trials, including the possibility of unfavorable clinical trial results, (viii) the market for, and marketability of, any product that is approved, (ix) the existence or development of vaccines, drugs, or other treatments for infection with the Human Immunodeficiency Virus that are viewed by medical professionals or patients as superior to the Companys products, (x) regulatory initiatives, compliance with governmental regulations and the regulatory approval process, (xi) general economic and business conditions, (xii) changes in foreign, political, and social conditions, and (xiii) various other matters, many of which are beyond the Companys control. Should one or more of these risks or uncertainties develop, or should underlying assumptions prove to be incorrect, actual results may vary materially and adversely from those anticipated, believed, estimated, or otherwise indicated by the Companys forward-looking statements.
The Company intends that all forward-looking statements made in this Current Report on Form 8-K will be subject to the safe harbor protection of the federal securities laws pursuant to Section 27A of the Securities Act of 1933, as amended, to the extent applicable. Except as required by law, the Company does not undertake any responsibility to update these forward-looking statements to take into account events or circumstances that occur after the date of this Current Report on Form 8-K. Additionally, the Company does not undertake any responsibility to update investors upon on the occurrence of any unanticipated events which may cause actual results to differ from those expressed or implied by these forward-looking statements.
|Item 9.01.||Financial Statements and Exhibits.|
|99.1||Press Release, dated June 22, 2018|
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.
|June 22, 2018||By:|
|Name:||Michael D. Mulholland|
|Title:||Chief Financial Officer|