CytoDyn Inc.

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CytoDyn, Inc. is a clinical-stage biotechnology company, which focuses on the clinical development of innovative treatments for multiple therapeutic indications based on its product candidate, leronlimab, a novel humanized monoclonal antibody targeting the C-C chemokine receptor type 5. Its pipeline includes Leronlimab Clinical Development Pipeline and Long-Acting CCR5 Inhibitor Development Pipeline. The company was founded by Allen D. Allen on May 2, 2002 and is headquartered in Vancouver, WA.

VANCOUVER, Washington, Nov. 04, 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 it has received clearance from the FDA to commence its Phase II oncology trial. The study will evaluate the efficacy of leronlimab in patients with relapsed/refractory microsatellite stable colorectal cancer (“CRC”).

CytoDyn Announces FDA Clearance of Its Phase II Oncology Trial

VANCOUVER, Wash., Oct. 30, 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 Dr. Melissa Palmer, M.D., has been engaged as Lead Consultant in Hepatology. In this role, Dr. Palmer will drive the Company's strategy for research and development in Hepatology, leveraging her expertise to further CytoDyn's clinical evaluation of leronlimab in treating liver conditions, including MASH and liver fibrosis. This engagement follows the recent breakthroughs with SMC Laboratories (“SMC”).

CytoDyn Appoints Dr. Melissa Palmer, M.D., as Lead Consultant in Hepatology; Announces Follow-Up Inflammation Studies with SMC Laboratories

Abstract to be presented at the 5 th annual HIV Research for Prevention Conference Study results highlight potential for treatment VANCOUVER, Washington, Oct. 07, 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, today announced acceptance of an abstract for presentation at the 5th annual HIV Research for Prevention Conference. The abstract summarizes research on the potential of combining early antiretroviral therapy (ART) with a novel immunotherapy approach using broadly neutralizing antibodies (bNAbs) and leronlimab.

CytoDyn Announces Abstract that Highlights Leronlimab's Potential in Mediating ART-Free Viral Control in Infant Rhesus Macaques

VANCOUVER, Washington, Oct. 04, 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 it has engaged Syneos Health as the contract research organization (“CRO”) for its upcoming Phase II oncology trial. The trial will evaluate the efficacy of leronlimab in patients with relapsed/refractory micro-satellite stable colorectal cancer (“CRC”).

CytoDyn Engages Syneos Health as CRO For Its Phase II Oncology Trial

VANCOUVER, Washington, Sept. 24, 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 a preliminary review of results from its preclinical study with SMC Laboratories.

CytoDyn Announces Preliminary Findings in Study with SMC Laboratories

VANCOUVER, Washington, Sept. 09, 2024 (GLOBE NEWSWIRE) -- Dear Shareholders, It continues to be a transformative year for CytoDyn Inc. (“CytoDyn” or the “Company”).

September 2024 Letter to Shareholders

VANCOUVER, Washington, Aug. 23, 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 it has engaged Syneos Health as the contract research organization (“CRO”) for its upcoming Phase II study exploring leronlimab and its effects on chronic inflammation.

CytoDyn Engages Leading CRO For Phase II Inflammation Trial

VANCOUVER, Washington, Aug. 12, 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 it completed a meeting with the U.S. Food and Drug Administration (FDA) to gain alignment on the rationale and proposed dosing for the Company's Phase II study that will investigate the preliminary safety and activity of leronlimab in combination with trifluridine plus tipiracil (TAS-102) and bevacizumab in participants with CCR5+, microsatellite stable (MSS), relapsed or refractory metastatic colorectal cancer (mCRC).

CytoDyn Announces Completion of FDA Meeting on Phase II Study of Leronlimab in Patients with Relapsed/Refractory Microsatellite Stable Colorectal Cancer

Terms of the settlement include $12,000,000 cash payment to CytoDyn and elimination of $14,000,000 accounts payable liability from the Company's balance sheet

CytoDyn Announces Settlement with Amarex Clinical Research LLC

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

VANCOUVER, Washington, May 28, 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 Dr. Jacob P. Lalezari, Chief Executive Officer, will host an investment community webcast on Thursday, May 30, 2024. Tanya Urbach, Board Chair, Mitch Cohen, Interim Chief Financial Officer, Tyler Blok, Executive Vice President, Legal Affairs, and Scott Hansen, Head of Research and Basic Science, will join Dr. Lalezari on the call. The Company update will address, among other items, the status of the Company's prospective clinical trials, recent developments with key research and development partners, and other opportunities the Company will be pursuing to further build out its development portfolio.

CytoDyn to Host Webcast to Provide Company Update

VANCOUVER, Washington, May 16, 2024 (GLOBE NEWSWIRE) -- Dear Shareholders, I write today to provide an update on CytoDyn Inc. (“CytoDyn” or “Company”), as we approach the end of our 2024 fiscal year (May 31, 2024), and to sincerely thank you for your unwavering support. Fiscal year 2024 was a significant year for CytoDyn, and one that I believe will be remembered as the beginning of a turnaround.

May 2024 Letter to Shareholders

Webcast to Provide Company Update on March 5, 2024 VANCOUVER, Washington, Feb. 29, 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 the FDA has lifted the clinical hold on leronlimab. The Company is now free to proceed with its proposed HIV clinical trial exploring leronlimab and its effects on chronic inflammation.

CytoDyn Announces FDA Has Lifted Clinical Hold

VANCOUVER, Washington, Feb. 01, 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 the Company has submitted its revised HIV clinical trial protocol to the FDA. The Company believes this submission will lead to the removal of the clinical hold currently in effect.

CytoDyn Announces Submission of Clinical Protocol to FDA and Initiation of Pre-Clinical Study in Glioblastoma

VANCOUVER, Washington, Jan. 29, 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 Dr. Jacob Lalezari, formerly interim CEO, was appointed to the CEO role, effective January 26, 2024.

CytoDyn Appoints Jacob Lalezari M.D. as CEO, Mitchell Cohen as Interim CFO

NEW YORK , Jan. 18, 2024 /PRNewswire/ -- Purcell & Lefkowitz LLP announces that it is investigating CytoDyn Inc. (OTC: CYDY) on behalf of the company's shareholders.  The investigation seeks to determine whether CytoDyn's directors breached their fiduciary duties in connection with recent corporate actions.

SHAREHOLDER ALERT: Purcell & Lefkowitz LLP Announces Shareholder Investigation of CytoDyn Inc. (OTC: CYDY)

VANCOUVER, Washington, Dec. 07, 2023 (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 Dr. Jacob P. Lalezari, interim Chief Executive Officer, will host an investment community webcast to provide a Company update on Thursday, December 14, 2023. The Company update will include discussion about recent comments from the FDA concerning the clinical hold, an anticipated timeline to respond to the FDA and resolve the clinical hold, the Company's next proposed clinical trial, the current approach to business development opportunities, and overall development strategy.

CytoDyn Announces Webcast to Provide Company Update

VANCOUVER, Washington, Nov. 21, 2023 (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, today announced the appointment of Dr. Jacob Lalezari as interim CEO, effective November 17, 2023. Dr. Lalezari will be responsible for leading the Company's corporate and product development, with a focus on short-term clinical development and related fundraising. Antonio Migliarese, who had been serving as interim president since May 2023, in addition to CFO, will resume his previous role as CFO.

CytoDyn Appoints Jacob Lalezari M.D. as Interim CEO

VANCOUVER, Washington, Nov. 03, 2023 (GLOBE NEWSWIRE) -- Dear Shareholders, We write to provide an update on CytoDyn Inc. (“CytoDyn” or “Company”), and to thank you for your continued support of the Company. Throughout our history, CytoDyn has made great strides in developing leronlimab from a single indication molecule into a platform molecule with the potential for multiple therapeutic indications.

November 2023 Letter to Shareholders

Claim Filed in Former CRO Litigation for Damages Exceeding $100M Dr. Arman Returns from Medical Leave as SVP of Business Operations Webcast to be held Monday, July 24 th , 2023, at 1 PM PT / 4 PM ET VANCOUVER, Washington, July 11, 2023 (GLOBE NEWSWIRE) -- CytoDyn Inc. (OTCQB: CYDY) (“CytoDyn” or the “Company”), a clinical-stage biotechnology company developing leronlimab, a CCR5 antagonist with the potential for multiple therapeutic indications, today announced that it has filed a supplemental Statement of Claim and formally requested a hearing date in its litigation proceeding against Amarex Clinical Research LLC (“Amarex”), the Company's former Contract Research Organization (“CRO”). The Company also announced that Dr. Cyrus Arman has returned to the Company, following his medical leave of absence, as Senior Vice President of Business Operations, a new role in which he will be working reduced hours.

CytoDyn Announces Company Updates and Investment Community Update Webcast

Antonio Migliarese assumes interim President role Dr. Melissa Palmer appointed interim Chief Medical Officer Dr. Salah Kivlighn joins CytoDyn as clinical and strategic advisor

CytoDyn Announces President Takes Medical Leave of Absence

VANCOUVER, Washington, April 05, 2023 (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 Tanya Urbach, Board Chair, Cyrus Arman, President, Antonio Migliarese, Chief Financial Officer, and Scott Hansen, our newly appointed Head of Research and Basic Science, will host an investment community webcast to provide a Company update on Tuesday, April 11, 2023.

CytoDyn to Hold Webcast to Provide a Company Update

VANCOUVER, Washington, Dec. 23, 2022 (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, will hold a webcast on December 29, 2022 at 8:00 a.m. Pacific Time (11:00 a.m. Eastern Time) to discuss the performance of leronlimab in its clinical trials and the recent charges against its former CEO Nader Pourhassan, who was previously terminated on January 24, 2022, and has had no affiliation with the Company since that time.

CytoDyn to Hold Webcast to Discuss the Performance of Leronlimab in Clinical Trials and Recent Charges Against Former CEO

The U.S. Department of Justice will prosecute the former CEO of Vancouver, Wash.-based biotech company CytoDyn, Nader Pourhassan, and an associate for allegedly defrauding investors.

Former CytoDyn CEO and clinical trial associate indicted for defrauding investors

VANCOUVER, Washington, Nov. 22, 2022 (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 it will host a virtual R&D Update on Wednesday, December 7, 2022, beginning at 11:00 a.m. Eastern Time / 8:00 a.m. Pacific Time.

News for CytoDyn Inc. Stock (CYDY)