Item 8.01. Other Events
On October 13, 2017, the Company announced that, in a meeting held on October 12, 2017, the U.S. Food and Drug Administration (the
FDA) confirmed the number and type of evaluable patients required for submission of a Biologics License Application (BLA) for PRO 140 as a combination therapy.
The FDA accepted the 40 patients currently enrolled in the Companys Phase 2b/3 pivotal combination trial as evaluable and further agreed that the
trials Data Monitoring Committee can conduct an interim efficacy analysis of primary endpoint. The FDA also confirmed that 50 patients will be required for the completion of this trial and agreed to allow more flexibility in the enrollment
criteria for the remaining 10 patients. As a result, the Company expects to complete enrollment within the near future. The FDA also confirmed that 300 patients will be required for the safety analysis in a BLA, which can be provided by all of the
Companys HIV trials, providing that those patients have been on a PRO 140 therapy for 24 weeks.
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 CD02 combination trial 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.
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