Live webcast to discuss announcement on March 31st
VANCOUVER, Wash., March 30, 2022 (GLOBE NEWSWIRE) — CytoDyn Inc. (OTCQB: CYDY) (“CytoDyn” or the “Company”), a late-stage biotechnology company developing leronlimab, a CCR5 antagonist with the potential for multiple therapeutic indications, announced that the U.S. Food and Drug Administration (FDA) issued a partial has imposed clinical lockdown on this company’s HIV program and a full clinical suspension of its COVID-19 program in the United States. In addition, the Company has elected to pause its COVID-19 studies in Brazil pending the results of its previously scheduled Data Safety Monitoring Committee meeting and is in the process of re-evaluating the timeline for resubmitting its HIV BLA.
The company did not enroll new patients in the suspended studies in the United States. The partial clinical suspension of the HIV program impacts patients currently enrolled in extension studies. These patients will be switched to other available therapeutics and no clinical trials can be initiated or resumed until the partial clinical lockdown is resolved. CytoDyn intends to work closely with the FDA to resolve the partial clinical ban as soon as possible. Under the full clinical suspension of the COVID-19 program, no new clinical trials may be initiated until the clinical suspension is lifted. The Company is not currently conducting COVID-19 studies in the United States as it is evaluating the most optimal programs to focus its resources and attention on.
“CytoDyn is committed to FDA compliance,” said Scott A. Kelly, MD, CytoDyn’s Chief Medical Officer. “We are evaluating our clinical programs and are working to resolve the issues underlying the clinical holds as quickly as possible in close coordination with the FDA. We will provide an update when we have more information.”
The Company will host a webcast conference call on March 31, 2022 at 5:30 am PT and 8:30 am ET to discuss this announcement and other updates. Connection details are given below:
About CytoDyn
CytoDyn is a clinical-stage biotechnology company focused on the development and commercialization of leronlimab, an investigational humanized IgG4 monoclonal antibody (mAb) designed to target the CC chemokine receptor type 5 (CCR5). Protein on the surface of certain immune systems to bind to cells thought to play a role in many disease processes. Cytodyn is investigating leronlimab in multiple therapeutic areas including infectious diseases, cancer and autoimmune diseases.
Forward-Looking Statements
This press release contains certain forward-looking statements that involve risks, uncertainties and assumptions that are difficult to predict. Words and phrases that reflect optimism, satisfaction, or disappointment about current prospects, such as “believes,” “hopes,” “intends,” “estimates,” “expects,” “projects,” “plans,” “anticipates,” and Variations thereof or the use of the future tense identify forward-looking statements, but their absence does not mean that a statement is not forward-looking. Forward-looking statements include, but are not limited to, statements about leronlimab, the Company’s ability to lift recent FDA clinical lockdowns, the safety and efficacy of leronlimab, and the Company’s ability to obtain regulatory approval for commercial sale. The Company’s forward-looking statements are not guarantees of performance, and actual results could differ materially from those contained in or expressed in such statements due to risks and uncertainties, including: (i) regulatory requirements regarding the safety and efficacy of leronlimab for treating the diseases and conditions , for which we are reviewing the product by the U.S. Food and Drug Administration (FDA) and various drug regulatory agencies in other countries; (ii) the Company’s ability to raise additional capital to fund its operations; (iii) the Company’s ability to meet its debt obligations; (iv) the Company’s ability to recruit a permanent CEO and retain other key employees; (v) the Company’s ability to enter into partnership or licensing agreements with third parties; (vi) the Company’s ability to timely identify patients for enrollment in its clinical trials; (vii) the timely and sufficient development, by internal resources or external consultants, of analyzes of the data generated from the Company’s clinical trials as required by the FDA or other regulatory agencies in connection with the Company’s BLA resubmission for HIV -Indication or other required applications for approval of the company’s drug product; (viii) the Company’s ability to achieve marketable product approval; (ix) the design, implementation and conduct of the Company’s clinical trials; (x) the results of the Company’s clinical trials, including the possibility of adverse clinical trial results; (xi) the market and marketability of Approved Products; (xii) the existence or development of any vaccine, drug or other treatment considered by healthcare professionals or patients to be superior to the Company’s products; (xiii) governmental initiatives, regulatory compliance and regulatory approval process; (xiv) any legal proceeding, inquiry or investigation involving the Company or its products; (xv) general economic and business conditions; (xvi) changes in foreign, political and social conditions; (xvii) any action or proposal by any shareholder with respect to the Company, its management or its Board of Directors; and (xviii) various other matters, many of which are beyond the Company’s control. The Company urges investors to review the various risk factors identified in its most recent Form 10-K and any risk factors or cautionary statements contained in subsequent Form 10-Qs and Form 8-Ks filed with Securities and Exchange Commission were expressly taken into account. Except as required by law, the Company assumes no obligation to update any forward-looking statements to reflect events or circumstances after the date of this press release.
CONTACTS
Investors:
Cristina de Leon
Office: 360.980.8524
[email protected]
Media:
Dan Zacchei / Joe Germani
Longacre Square Partners
[email protected] / [email protected]
Source: CytoDyn Inc.
Released March 30, 2022