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.
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 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.