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CYTODYN INC - CYDY STOCK NEWS

Welcome to our dedicated page for CYTODYN news (Ticker: CYDY), a resource for investors and traders seeking the latest updates and insights on CYTODYN stock.

CYDY is a clinical-stage biotechnology company focused on developing leronlimab, a humanized IgG4 monoclonal antibody that targets CCR5, a protein on immune system cells. Having invested in clinical trials, CYDY aims to revolutionize treatment across multiple therapeutic areas including HIV, oncology, MASH, and MASLD. Despite facing challenges in FY23, the company took measures to conserve resources, reduce operating expenses, and position itself for near-term and long-term success. CYDY is focused on completing the resolution of the FDA's partial clinical hold and exploring various therapeutic indications for leronlimab to maximize patient and practitioner benefits.

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CytoDyn Inc. provides an update on its progress in developing leronlimab for multiple therapeutic indications. The company has faced delays in satisfying the FDA's clinical hold submission requirements, but has gained new insights and engaged with key opinion leaders in the HIV treatment field. CytoDyn has implemented cost-cutting measures and is focused on resolving the clinical hold and strengthening its leadership team. The company is also exploring potential indications for leronlimab and is involved in ongoing litigation. Shareholders are encouraged to vote on increasing the total number of authorized shares of common stock.
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CytoDyn Inc. (OTCQB: CYDY) announced an upcoming webcast for the investment community scheduled on April 11, 2023, at 1:00 PM PT / 4:00 PM ET. The update will feature key executives, including Board Chair Tanya Urbach and President Cyrus Arman, discussing the company’s progress and the potential of leronlimab, a CCR5 antagonist. Questions can be submitted prior to the event until Noon PT on April 7, 2023, and will be addressed during the presentation if appropriate. A replay will be available approximately one hour after the event until May 11, 2023.

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CytoDyn Inc. (OTCQB: CYDY) will hold a webcast on December 29, 2022, at 8:00 a.m. PT to discuss the performance of its investigational drug, leronlimab, in clinical trials. The discussion will also address recent charges against former CEO Nader Pourhassan, who was terminated on January 24, 2022, and has since had no association with the company. CytoDyn is focused on developing leronlimab for various therapeutic applications, including infectious diseases, cancer, and autoimmune conditions. The webcast replay will be available until January 29, 2023.

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CytoDyn Inc. (OTCQB: CYDY) will host a virtual R&D Update on December 7, 2022, at 11:00 a.m. ET. The event will feature presentations by key management and Scientific Advisory Board members discussing the clinical development of leronlimab, a CCR5 antagonist. Presenters include Cyrus Arman, M.D., who will overview the R&D strategy; Mazen Noureddin, M.D., discussing leronlimab's potential in treating NASH; Stefan Glück, M.D., focused on cancer therapy; and Jonah Sacha, Ph.D., on HIV research. The event can be accessed via the company's website.

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CytoDyn (OTCQB: CYDY) announced the voluntary withdrawal of its Biologics License Application (BLA) for leronlimab, aimed at treating HIV-MDR patients. The decision stems from concerns over data quality from a clinical research organization (CRO). Despite meeting primary endpoints in trials, the company believes FDA approval is unlikely without substantial investments. CytoDyn plans to respond to a clinical hold and continue exploring leronlimab's effectiveness in other areas, including NASH and oncology, where promising results have been observed. A webcast will provide further updates on these developments.

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CytoDyn Inc. (OTCQB: CYDY) announces significant changes to its Board of Directors with the appointments of Stephen Simes and Ryan Dunlap as independent directors. Simes brings over 40 years of experience in biopharmaceuticals, having successfully led various companies, while Dunlap has 25 years of finance and operations expertise. The changes aim to enhance the board’s independence and industry experience, following the resignation of Dr. Scott Kelly as a director, although he remains Chief Medical Officer. This strategic move is positioned to strengthen corporate governance and focus on CytoDyn's therapeutic developments.

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CytoDyn Inc. (OTCQB: CYDY) announced an investment community webcast scheduled for September 28, 2022, at 1:00 pm PT / 4:00 pm ET. The event will feature Board Chair Tanya Urbach, President Cyrus Arman, CFO Antonio Migliarese, and CMO Scott Kelly, who will provide a quarterly update on the company's developments, particularly regarding leronlimab, a CCR5 antagonist. Questions for the webcast can be submitted until Noon PT on September 26, 2022. A replay will be available after the event until October 28, 2022.

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CytoDyn Inc. (OTCQB: CYDY) announced the appointment of Dr. Cyrus Arman as President effective July 9, 2022. He brings over 15 years of experience, most recently serving as Chief Business Officer at Nimble Therapeutics. Dr. Arman is expected to transition to Chief Executive Officer and join the Board of Directors within six months. Board Chair Tanya Urbach expressed confidence in his leadership, highlighting his strategic abilities to enhance shareholder value and advance the company’s drug, leronlimab, which targets various medical conditions. Antonio Migliarese resumes his role as CFO.

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FAQ

What is the current stock price of CYTODYN (CYDY)?

The current stock price of CYTODYN (CYDY) is $0.1175 as of December 23, 2024.

What is the market cap of CYTODYN (CYDY)?

The market cap of CYTODYN (CYDY) is approximately 134.2M.

What operational and financial adjustments did the Company make in fiscal year 2023?

In fiscal year 2023, CYDY implemented significant reductions in its workforce, cash burn rate, and operating expenses to preserve resources and focus on critical corporate priorities. Workforce reductions, alongside expense reduction measures, led to improved cash burn and expense run rates.

What is the status of the clinical hold?

CYDY recently provided additional information to the FDA to address remaining questions and hopes for the removal of the clinical hold. The company stands ready to address further issues and is optimistic about a successful resolution.

What is the short-term development plan for leronlimab following the resolution of the clinical hold?

Post the resolution of the clinical hold, CYDY will focus on a multipronged therapeutic approach to leronlimab. Initiatives include KOL-identified studies in HIV, pre-clinical combination therapy trials in MASH and oncology, and potential partnership opportunities.

What is the current status of the longer-acting therapeutic project?

CYDY is collaborating with a partner utilizing AI technology to develop a long-acting therapeutic enhancing its existing IP portfolio and attracting partnership opportunities, potentially increasing shareholder value.

What is the current status of the CEO search?

The CEO search has narrowed to qualified candidates, with an expected new CEO appointment by the year-end to enhance the company's business strategies and drug commercialization efforts.

How does the Company make decisions regarding executive compensation?

The Compensation Committee of the Board reviews, appoints independent members, and oversees executive compensation plans annually based on recommendations from an independent executive compensation advisory firm, ensuring competitive industry standards and talent retention.

What is the current status of the Amarex litigation effort?

CYDY is pursuing litigation against Amarex for its failures in clinical trial management, fully funding legal representation by Sidley Austin LLP. The final arbitration hearing is scheduled for August 2024, demonstrating the Company's commitment to maximizing recovery.

What is the status of the new communication strategy?

CYDY is shifting its communication strategy to be clear, concise, and frequent, engaging with stakeholders, and responding to inquiries. The Company aims to provide updates via SEC filings, direct communications, and a planned FAQ section on its website.

What clinical trials is the Company currently working on?

CYDY is focused on conducting Phase II clinical trials, with priorities set on oncology trials and inflammation studies to clarify leronlimab's effectiveness. The Company is also exploring research and development partnerships to further enhance its product development portfolio.

Is leronlimab currently available to the public outside of a clinical trial?

Leronlimab, as an unapproved drug, is not available to the general public. However, certain patients facing critical illnesses may access early investigational drugs under Expanded Access or Right to Try programs, subject to FDA approvals and requirements.

CYTODYN INC

OTC:CYDY

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134.18M
1.21B
0.78%
0.03%
Biotechnology
Healthcare
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United States of America
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