CytoDyn Announces Management Transition Plan to Support Regulatory Approval and Commercialization of Leronlimab
VANCOUVER, Wash.–(BUSINESS WIRE)–Today, the board of directors (“Board”) of CytoDyn Inc. (OTCQB: CYDY) (“CytoDyn” or the “Company”), a biotechnology company developing the CCR5 antagonist leronlimab with potential for multiple therapeutic indications, announced a leadership transition plan. Effective immediately, Antonio Migliarese, currently CytoDyn’s CFO, has been named interim chairman. The Board of Directors terminated the employment of Nader Z. Pourhassan, Ph.D., as President and Chief Executive Officer of the Company and he is no longer a member of the Board of Directors, effective dated January 24, 2022. The rest of CytoDyn’s leadership team continues with the Company and is united in its commitment to advancing the Company’s goals.
A three-member board committee has been appointed to initiate the search for a new permanent CEO, with a focus on identifying a candidate with the required experience in the pharmaceutical industry to strengthen the Company’s efforts to obtain regulatory approval and commercialization of leronlimab. Mr. Migliarese will also continue in his role as the company’s Chief Financial Officer during this interim period.
Scott A. Kelly, MD, Chairman of the Board and Chief Medical Officer of CytoDyn, said, “Now is the right time for the next phase of CytoDyn’s evolution, as we focus on continuing the clinical progress of leronlimab and ultimately achieving regulatory approval and commercialization. Our Board of Directors is fully focused on identifying the best possible candidate to move the company forward, and we focus our search on finding someone with the right experience and skills to maximize the potential of leronlimab for patients, partners and shareholders. Additionally, in an effort to strengthen the independence of the Board, I have elected to step down as Chairman of the Board, but will remain on the Board. The board elected Tanya Durkee Urbach, an independent director who has experience in corporate governance, corporate finance, business growth and securities litigation, compliance and regulatory matters, as Chairman of the Board. We thank Dr. Pourhassan for his vision and passion for developing leronlimab into a platform molecule with potential for multiple therapeutic indications.
CytoDyn will keep shareholders and stakeholders informed of the company’s progress in implementing its leadership transition plan, as appropriate.
CytoDyn is a clinical-stage biotechnology company focused on the development and commercialization of leronlimab, an investigational humanized IgG4 monoclonal antibody (mAb) designed to bind to the CC chemokine receptor type 5 (CCR5), a protein surface of some immune systems. cells thought to play a role in many disease processes. Cytodyn is studying leronlimab in several therapeutic areas, including infectious diseases, cancer and autoimmune diseases.
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 the future tense, identify forward-looking statements, but their absence does not mean that a statement is not forward-looking. Forward-looking statements specifically include statements about leronlimab, its ability to provide positive health outcomes, possible results of or ability to continue clinical trials, studies, or other programs, the ability to obtain regulatory approval 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 differ materially from those contained or expressed in such statements due to risks and uncertainties, including: (i) regulatory determinations of safety and the effectiveness of leronlimab in treating the diseases and conditions for which we are reviewing the product by the US Food and Drug Administration (FDA) and various drug regulatory agencies in other countries; (ii) the ability of the Company to raise additional capital to finance its operations; (iii) the ability of the Company to honor its debts; (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 license agreements with third parties; (vi) the Company’s ability to identify patients to enroll in its clinical trials in a timely manner; (vii) the timely and sufficient development, through internal resources or third-party consultants, of analyzes of data generated by the Company’s clinical trials required by the FDA or other regulatory agencies under the new submission of the Company’s BLA for the HIV indication or other Company’s drug product approval applications; (viii) the Company’s ability to obtain 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 merchantability of any Approved Product; (xii) the existence or development of vaccines, drugs or other treatments that are considered by healthcare professionals or patients to be superior to the Company’s products; (xiii) regulatory initiatives, compliance with government regulations and the regulatory approval process; (xiv) legal proceedings, investigations or inquiries regarding the Company or its products; (xv) general economic and commercial conditions; (xvi) changes in foreign, political and social conditions; (xvii) actions or shareholder proposals relating 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 specifically review the various risk factors identified in its most recent Form 10-K, as well as any risk factors or cautionary statements included in subsequent Forms 10-Q and 8-K, filed with the Securities and Exchange Commission. Except as required by law, the Company assumes no responsibility to update forward-looking statements to reflect events or circumstances that occur after the date of this press release.