CytoDyn Announces President Takes Medical Leave of Absence - Seite 3

Dr. Palmer said, "I am excited about joining CytoDyn to support the further development of leronlimab following its impressive phase 2 data in patients with NASH. I am eager to help accelerate the NASH clinical development program and look forward to working with the Company's talented team and Dr. Kivlighn, with whom I’ve had the pleasure of working in the past.” Dr. Kivlighn stated, “I have had the pleasure of getting to know the Company’s Board of Directors and Tanya, Cyrus and Antonio, in addition to gaining an understanding of leronlimab, the current status of its development programs, the potential it has in various indications, and the current objectives related to the HIV clinical hold and future NASH clinical trial. I am thrilled to be able to leverage my experience and knowledge of the Company to support Antonio and the Company’s clinical, regulatory, and strategic efforts during Dr. Arman’s leave of absence.” Tanya Urbach, Board Chair, said “Given the unanticipated circumstances, we are blessed to have had such a talented CMO as Dr. Palmer recently join the Company. We are further grateful for Dr. Kivlighn’s willingness to step in and support Antonio and the team at this time. Dr. Palmer and Dr. Kivlighn each bring significant experience not only in the oncology and NASH spaces but also in leadership roles with clinical and drug development companies. I believe these two individuals, coupled with Antonio’s strong management abilities, will allow us to not miss a beat during Cyrus’s absence.”

About CytoDyn
CytoDyn is a clinical-stage biotechnology company focused on the development and commercialization of leronlimab, an investigational humanized IgG4 monoclonal antibody (mAb) that is designed to bind to C-C chemokine receptor type 5 (CCR5), a protein on the surface of certain immune system cells that is believed to play a role in numerous disease processes. CytoDyn is studying leronlimab in multiple therapeutic areas, including infectious disease, cancer, and autoimmune conditions.

Forward-Looking Statements
This press release contains certain forward-looking statements that involve risks, uncertainties and assumptions that are difficult to predict. 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. Forward-looking statements may include statements about leronlimab, its ability to provide positive health outcomes, the Company’s ability to resolve the clinical hold imposed by the FDA, the Company's ability to develop a successful operating strategy and thereby create shareholder value, the ability to obtain regulatory approval of the Company’s drug products for commercial sales, and the market for actual commercial sales. The Company's forward-looking statements are not guarantees of performance, and actual results could vary materially from those contained in or expressed by such statements due to risks and uncertainties, including: (i) the regulatory determinations of leronlimab’s safety and effectiveness to treat the diseases and conditions for which we are studying 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 and other payment obligations; (iv) the Company’s ability to recruit and retain key employees; (v) the Company’s ability to enter into partnership or licensing arrangements with third parties; ((vi) the timely and sufficient development, through internal resources or third-party consultants, of analyses of the data generated from the Company’s clinical trials required by the FDA or other regulatory agencies in connection with applications for approval of the Company’s drug product; (vii) the Company’s ability to achieve approval of a marketable product; (viii) the design, implementation and conduct of the Company’s clinical trials; (ix) the results of any such clinical trials, including the possibility of unfavorable clinical trial results; (x) the market for, and marketability of, any product that is approved; (xi) the existence or development of vaccines, drugs, or other treatments that are viewed by medical professionals or patients as superior to the Company’s products; (xii) regulatory initiatives, compliance with governmental regulations and the regulatory approval process; (xiii) legal proceedings, investigations or inquiries affecting the Company or its products; (xiv) general economic and business conditions; (xv) changes in foreign, political, and social conditions; (xvi) stockholder actions or proposals with regard to the Company, its management, or its board of directors; and (xvii) various other matters, many of which are beyond the Company’s control. The Company urges investors to consider specifically the various risk factors identified in its most recent Form 10-K, and risk factors or cautionary statements included in subsequent Form 10-Qs and Form 8-Ks, filed with the Securities and Exchange Commission. Except as required by law, the Company does not undertake any responsibility to update any forward-looking statements to take into account events or circumstances that occur after the date of this press release.