The Company recently received a letter from the Office of Orphan Products Development at
the Food and Drug Administration (the “FDA”) in response to the Company’s previously disclosed request for orphan-drug designation with respect to PRO 140 for the treatment of graft versus host disease (“GvHD”). Pursuant to
the letter, the FDA has requested (a) additional population data to support that the prevalence of patients with acute and chronic GvHD is less than 200,000 in the United States and (b) additional scientific rationale to support orphan
drug designation for PRO 140 for the treatment of GvHD, which the Company intends to provide through either (i) the clinical data derived from its current Phase 2 GvHD trial or (ii) a pre-clinical study of the use of PRO 140 in an
in
vivo
animal model of GvHD. The FDA requested that such information be provided to the FDA by May 2017. The Company has not yet determined which alternative to pursue to provide the requested data. In the interim, the Company intends to gather
the additional population data.
As previously announced, the Company will be hosting an investment community conference call on Wednesday, May 11,
2016 at 1:00 p.m. PT/4:00 p.m. ET to provide an update on clinical and regulatory developments. Interested participants and investors may access this conference call by dialing 877-407-2986 (U.S./Canada) or 201-378-4916 (international).
A live audio webcast may also be accessed via the Investors section of CytoDyn’s corporate web site at www.cytodyn.com, and will be archived for 60 days.
A replay of the conference call will be available until July 11, 2016. To access the replay, interested parties may dial 877-660-6853 (U.S./Canada) or 201-612-7415 (international); Conference ID: 13578723.
1
Forward-Looking Statements
This Form 8-K contains certain forward-looking statements that involve risks, uncertainties and assumptions that are difficult to predict. 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. Such 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 readers should specifically consider the various risk factors identified in the
Company’s Form 10-K for the fiscal year ended May 31, 2015 (filed July 10, 2015), Forms 10-Q for the fiscal quarters ended August 31, 2015 (filed October 9, 2015), November 30, 2015 (filed January 11, 2016)
and February 29, 2016 (filed April 13, 2016), and other reports filed with the U.S. Securities and Exchange Commission, including the matters set forth under the heading “Risk Factors” therein, any of which could cause actual
results to differ materially from those indicated by these forward-looking statements.
These forward-looking statements reflect the Company’s
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. Readers should not place undue reliance on these forward-looking
statements, which are subject to risks and uncertainties relating to, among other things: (i) the sufficiency of the Company’s cash position, (ii) the Company’s ability to achieve approval of a marketable product,
(iii) design, implementation and conduct of clinical trials, (iv) the results of the Company’s clinical trials, including the possibility of unfavorable clinical trial results, (v) the market for, and marketability of, any
product that is approved, (vi) 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 Company’s
products, (vii) regulatory initiatives, compliance with governmental regulations and the regulatory approval process, (viii) general economic and business conditions, (ix) changes in foreign, political, and social conditions, and
(x) various other matters, many of which are beyond the Company’s 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 these forward-looking statements.
The Company intends that all forward-looking
statements made herein 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 filing. Additionally, the Company does not undertake any responsibility to update these
forward-looking statements on the occurrence of any unanticipated events which may cause actual results to differ from those expressed or implied by these forward-looking statements.