On November 5, 2018, CytoDyn Inc., a Delaware corporation (the Company) announced that its previously disclosed acquisition of ProstaGene, LLC
(ProstaGene) is anticipated to close on or about December 7, 2018. A copy of a related notice to certain security holders of the Company is filed as Exhibit 99.1 to this
Form 8-K.
This communication does not constitute an offer to sell or the solicitation of an offer to buy any securities, nor shall there be any sale of securities
in any jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such jurisdiction. This communication is not a substitute for any prospectus or any other
document which may be filed with the United States Securities and Exchange Commission (the SEC) in connection with the ProstaGene transaction.
Point NewCo Inc., an affiliate of the Company, has filed with the SEC a registration statement on
Form S-4,
including a preliminary prospectus, relating to the ProstaGene transaction (the
Form S-4).
INVESTORS AND SECURITY HOLDERS ARE URGED TO READ THE FORM
S-4
AND ANY OTHER RELEVANT DOCUMENTS THAT MAY BE FILED WITH THE SEC CAREFULLY AND IN THEIR ENTIRETY, BECAUSE THEY CONTAIN IMPORTANT INFORMATION ABOUT THE PROSTAGENE TRANSACTION. Investors and security holders are able to obtain free copies of the
Form
S-4
and any other documents filed with the SEC through the web site maintained by the SEC at http://www.sec.gov/.
Forward-Looking Statements
This Form
8-K contains
certain forward-looking statements that involve risks, uncertainties and assumptions that are difficult to predict, including statements regarding the proposed transaction with ProstaGene, the
likelihood of closing the proposed transaction with ProstaGene, the Companys clinical focus, and the Companys current and proposed trials. 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, 2018 in the section titled Risk Factors in Part I, Item 1A, as updated by the
Form 10-Q
for the fiscal period ended August 31, 2018 in the
section titled Risk Factors in Part II, Item 1A, 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 HIV 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 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