On December 7, 2017, the Company announced that the Independent Data Monitoring
Committee (IDMC) for the Companys PRO 140 pivotal combination therapy trial has completed a planned interim analysis of efficacy data for the first 40 patients and has recommended that the trial be continued as planned with the protocol
defined sample size and power to achieve the primary endpoint. The Phase 2b/3 pivotal trial requires a total of 50 patients for completion.
Forward-Looking Statements
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 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, 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, (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.