CytoDyn Announces Start of Preclinical MASH Study, Results Expected in Fall 2024

Rhea-AI Summary

CytoDyn, a biotechnology company working on leronlimab, announced the start of a preclinical MASH study with SMC Laboratories. The study aims to clarify optimal dosing and evaluate combination therapy potential, with results expected in Fall 2024. The study will assess leronlimab's effectiveness in preventing or reversing liver fibrosis at 350 and 700 mg doses, alone and combined with Resmetirom. CytoDyn's CEO, Dr. Jacob Lalezari, emphasized this study's importance for future partnerships in the MASH space, even as the company focuses on oncology and inflammation therapies.

Positive

• CytoDyn has commenced a preclinical MASH study which is important for developing future partnerships in the MASH space.
• The study is set to clarify the optimal dosing and evaluate combination therapy potentials, enhancing the efficacy of leronlimab.
• The study includes evaluating leronlimab's potential in preventing or reversing liver fibrosis, indicating a new therapeutic avenue.

Negative

• Results of the preclinical MASH study are not expected until Fall 2024, potentially delaying any immediate impacts on stock performance.

VANCOUVER, Washington, June 27, 2024 (GLOBE NEWSWIRE) -- CytoDyn Inc. (OTCQB: CYDY) ("CytoDyn" or the "Company"), a biotechnology company developing leronlimab, a CCR5 antagonist with the potential for multiple therapeutic indications, announced today that its preclinical MASH study with SMC Laboratories, Inc. (“SMC”) has commenced, with results expected in the fall of 2024.

CytoDyn believes its prior MASH study demonstrated a statistically significant benefit of leronlimab at a dosing level of 350 mg. To clarify the optimal dosing and evaluate the potential for combination therapy, SMC will be conducting a twelve-week preclinical mouse study evaluating both 350 and 700 mg dose levels, alone and in combination with Resmetirom, a drug recently approved by the FDA. The study will evaluate leronlimab’s potential role in preventing and/or reversing liver fibrosis.

CytoDyn’s CEO, Dr. Jacob Lalezari, stated, “in addition to clarifying dosing and efficacy, the goal of this study is to eventually use the results to pursue partnerships in the MASH space. Although CytoDyn will be primarily focused on oncology and inflammation in the coming months, we do believe that leronlimab could have a significant role in the treatment of MASH, whether as a standalone therapeutic or in a combination therapy approach.”

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 has studied 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 implement a successful operating strategy for the development of leronlimab and thereby create shareholder value, the ability to obtain regulatory approval of the Company’s drug products for commercial sales, and the strength of the Company’s leadership team. 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 (the “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.

CONTACT
Investor Relations 
CytoDyn Inc.
ir@cytodyn.com

FAQ

What is CytoDyn's latest study about?

CytoDyn has started a preclinical MASH study to evaluate leronlimab's dosing and potential in combination therapy, with results expected in Fall 2024.

When will the results of CytoDyn's MASH study be available?

The results of CytoDyn's preclinical MASH study are expected in Fall 2024.

What doses of leronlimab are being tested in CytoDyn's MASH study?

CytoDyn's MASH study is testing leronlimab at 350 mg and 700 mg doses, alone and in combination with Resmetirom.

Why is CytoDyn conducting a preclinical MASH study?

CytoDyn is conducting the preclinical MASH study to clarify optimal dosing, evaluate combination therapy potential, and explore leronlimab's role in treating liver fibrosis.

How might CytoDyn's MASH study impact the company's future?

The MASH study aims to provide data for future partnerships in the MASH space and potentially expand the therapeutic applications of leronlimab.

What is the focus of CytoDyn's upcoming months according to the latest PR?

CytoDyn will primarily focus on oncology and inflammation therapies in the upcoming months.