CytoDyn Inc. (OTCMKTS:CYDY) Files An 8-K Regulation FD DisclosureItem 7.01Regulation FD Disclosure.
On October13, 2017, CytoDyn Inc. (the “Company”) issued a press release relating to the announcement described in Item 7.01 below, a copy of which is furnished as Exhibit 99.1 to this Form 8-K.
Item 7.01.Other Events
On October13, 2017, the Company announced that, in a meeting held on October12, 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 Company’s Phase 2b/3 pivotal combination trial as evaluable and further agreed that the trial’s 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 Company’s 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 Company’s 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 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 May31, 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 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 CD02 combination trial 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, (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 the Human Immunodeficiency Virus 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 to Section27A 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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Item 7.01.Financial Statements and Exhibits.
| (d) |
Exhibit No. |
Description. |
| 99.1 | Press Release, dated October13, 2017 |
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CytoDyn Inc. ExhibitEX-99.1 2 d475876dex991.htm EX-99.1 EX-99.1 Exhibit 99.1 CYTODYN PROVIDES UPDATE ON PRO 140 COMBINATION THERAPY PIVOTAL TRIAL IN HIV PATIENTS FOLLOWING CONSTRUCTIVE MEETING WITH FDA Interim efficacy analysis of primary endpoint to be conducted in coming weeks Company to hold investment community conference call on October 19 VANCOUVER,…To view the full exhibit click here
About CytoDyn Inc. (OTCMKTS:CYDY)
CytoDyn Inc. is a clinical-stage biotechnology company. The Company is focused on the clinical development and commercialization of humanized monoclonal antibodies to treat Human Immunodeficiency Virus (HIV) infection. The Company’s lead product candidate, PRO 140, belongs to a class of HIV therapies known as entry inhibitors that block HIV from entering into and infecting certain cells. The Company’s product pipeline also includes Cytolin and CytoFeline. Cytolin is a mouse monoclonal antibody developed to identify a specific type of immune cell called a cytotoxic T cell, or cytotoxic T lymphocyte (CTL). CytoFeline is an anti-lymphocyte function-associated antigen-1 (LFA-1) antibody for the treatment of Feline Immunodeficiency Virus (FIV) infection. PRO 140 blocks HIV from entering a cell by binding to a molecule called C-C chemokine receptor type 5 (CCR5). The Company has finished Phase II clinical trials for PRO 140 with demonstrated antiviral activity in man.