Item 8.01 Other Events.
On July 12, 2018,
the Company announced a strategic expansion of its clinical focus to include the evaluation of PRO 140 in certain cancers and immunological indications where CCR5 antagonism has shown initial promise.
In connection with such expansion, on July 12, 2018, the Company signed a
non-binding
letter of intent regarding
a proposed acquisition of intellectual property and other assets of ProstaGene LLC (“ProstaGene”), a privately held company focused on prostate cancer diagnostics and therapeutics aimed at blocking cancer metastasis by blocking CCR5. At
the same time, the Company remains committed to advancing its clinical programs with PRO 140 in HIV and graft-versus-host disease (“GvHD”), and is continuing with its previously announced plans to submit a Biologics License Application to
the U.S. Food and Drug Administration (the “FDA”) for PRO 140 as a combination therapy for HIV.
As part of the proposed transaction with
ProstaGene, Richard G. Pestell, M.D., Ph.D., M.B.A., F.A.C.P., F.R.A.C.P., the Chief Executive Officer of ProstaGene and President of the Pennsylvania Cancer and Regenerative Medicine Research Center, will join the Company as Chief Medical Officer.
It is also expected that Dr. Pestell will join the Company’s Board of Directors at the closing of the transaction. The transaction is subject to completion of due diligence review, customary definitive documentation, deal structure and
requisite corporate and regulatory approvals. The final terms of the transaction will be available upon the execution of definitive documentation.
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 proposed transaction with ProstaGene, the likelihood of closing the proposed transaction with ProstaGene, the Company’s clinical focus, and the Company’s 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 Company’s
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 Company’s 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 quarterly period ended February 28, 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
Company’s forward-looking statements.
The Company’s 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 Company’s forward-looking statements, which are subject to risks and
uncertainties relating to, among other things: (i) the sufficiency of the Company’s cash position and the Company’s ongoing ability to raise additional capital to fund its operations, (ii) the Company’s ability to complete
its Phase 2b/3 pivotal combination therapy trial for PRO 140 (CD02) and to meet the FDA’s requirements with respect to safety and efficacy to support the filing of a Biologics License Application, (iii) the Company’s ability to meet
its debt obligations, if any, (iv) the Company’s ability to identify patients to enroll in its clinical trials in a timely fashion, (v) the Company’s ability to achieve approval of a marketable product, (vi) design,
implementation and conduct of clinical trials, (vii) the results of the Company’s 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 Company’s 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 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 the Company’s 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 the occurrence of any unanticipated events which may cause actual results to differ from those expressed or implied
by these forward-looking statements.