Articles from CytoDyn Inc.

Survival observations in mTNBC patients correlated with increased PD-L1 expression

VANCOUVER, Washington, May 06, 2025 (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 that Robert E. Hoffman has been appointed as Chief Financial Officer, effective May 15, 2025. He will take over the CFO position from Mitch Cohen, who had been serving as CFO on an interim basis since February 2024.

Dr. Jacob Lalezari, CEO, and Dr. Richard Pestell, Lead Consultant in Preclinical and Clinical Oncology, to lead CytoDyn group in attendance

VANCOUVER, Washington, March 18, 2025 (GLOBE NEWSWIRE) -- Dear Shareholders,

VANCOUVER, Washington, Feb. 24, 2025 (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 encouraging survival outcomes among a group of patients with metastatic triple-negative breast cancer (“mTNBC”) treated with leronlimab. Although mTNBC typically has a poor prognosis, observed survival rates at 12, 24, and 36 months after treatment with leronlimab compare favorably with reported life expectancy after treatment with currently approved therapies. In addition, the Company confirmed that a small group of patients who failed treatment after developing metastatic disease survived more than 36 months after receiving leronlimab, are alive today, and currently identify as having no evidence of ongoing disease.

VANCOUVER, Washington, Feb. 06, 2025 (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 positive results from its preclinical studies with SMC Laboratories (“SMC”).

VANCOUVER, Washington, Dec. 17, 2024 (GLOBE NEWSWIRE) --

VANCOUVER, Washington, Nov. 25, 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 Richard Pestell, M.D., Ph.D., has been appointed as Lead Consultant, Preclinical and Clinical Oncology. Dr. Pestell will lead the Company’s research and development strategy in oncology and utilize his expertise and vast network to further CytoDyn’s clinical evaluation of the capabilities for leronlimab in cancer treatment.

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”).

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”).

VANCOUVER, Washington, Oct. 08, 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 Max Lataillade, DO, MPH, has been appointed as Senior Vice President and Head of Clinical Development. Under his consulting agreement, Dr. Lataillade will lead the Company’s global research and development strategy and oversee end-to-end R&D activities to advance the Company’s clinical development pipeline.

Abstract to be presented at the 5th annual HIV Research for Prevention Conference

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”).

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.

VANCOUVER, Washington, Sept. 09, 2024 (GLOBE NEWSWIRE) --

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.

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).

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

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.

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.

VANCOUVER, Washington, May 16, 2024 (GLOBE NEWSWIRE) --

Webcast to Provide Company Update on March 5, 2024

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.

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.

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.

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.

VANCOUVER, Washington, Nov. 03, 2023 (GLOBE NEWSWIRE) --

Claim Filed in Former CRO Litigation for Damages Exceeding $100M

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

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.

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.

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.

Company to complete and submit responses to FDA clinical hold

Stephen Simes career public biotech company CEO and Ryan Dunlap CFO with public biotech company experience join Board

Today the Board of Directors (“the Board”) of CytoDyn Inc. (OTCQB: CYDY) ("CytoDyn" or the "Company"), a biotechnology company developing leronlimab, a CCR5 antagonist with the potential for multiple therapeutic indications, announced a leadership transition plan. Effective immediately, Antonio Migliarese, currently CytoDyn’s Chief Financial Officer, has been appointed interim President. The Board of Directors terminated the employment of Nader Z. Pourhassan, Ph.D., as President and CEO of the Company and he is no longer a member of the Board of Directors, effective January 24, 2022. The rest of CytoDyn’s executive team is continuing with the Company and is united in their commitment to advance the Company’s objectives.

CytoDyn Inc. (OTCQB: CYDY) (“CytoDyn” or the “Company”), a late-stage biotechnology company developing leronlimab, a CCR5 antagonist with the potential for multiple therapeutic indications, announced it has canceled its webcast scheduled for today, Thursday, January 13, 2022 and will provide an update at a future date.

CytoDyn Inc. (OTCQB: CYDY) (“CytoDyn” or the “Company”), a late-stage biotechnology company developing leronlimab, a CCR5 antagonist with the potential for multiple therapeutic indications, today announced that a research paper entitled “Leronlimab (PRO 140) activity against 4-class drug resistant HIV-1 from Heavily Treatment Experienced Subjects” has been accepted, peer reviewed and is available as a journal pre-proof on ScienceDirect. ScienceDirect provides access to a large bibliographic database of scientific and medical publications of the Dutch publisher Elsevier. This article is available for purchase from Elsevier through a link on CytoDyn’s website:

CytoDyn Inc. (OTCQB: CYDY) ("CytoDyn" or the "Company"), a late-stage biotechnology company developing leronlimab, a CCR5 antagonist with the potential for multiple therapeutic indications, announced positive results from the 350 mg weekly dose of its Phase 2 NASH clinical trial. The trial was conducted in two parts. Part 1 compared a 700 mg weekly dose and placebo in a double-blind randomized manner and Part 2 evaluated a 350 mg weekly dose as an open label study compared to the same placebo blinded arm. Results of the topline report will be announced when available.

CytoDyn Inc. (OTCQB: CYDY) (“CytoDyn” or the “Company”), a late-stage biotechnology company developing leronlimab, a CCR5 antagonist with the potential for multiple therapeutic indications, today announced that the U.S. District Court for the District of Maryland has granted CytoDyn’s previously-announced motion for a preliminary injunction against NSF International, Inc. and its subsidiary Amarex Clinical Research (“Amarex”), the Company’s former Contract Research Organization (“CRO”).

CytoDyn Inc. (OTCQB: CYDY) (“CytoDyn” or the “Company”), a late-stage biotechnology company developing leronlimab, a CCR5 antagonist with the potential for multiple therapeutic indications, today announced that it has received a positive response from the U.S. Food and Drug Administration (“FDA”) to conduct a Phase 3, randomized, double blind, placebo controlled trial to evaluate the efficacy and safety of leronlimab in combination with standard of care for critically ill patients with COVID-19 pneumonia with need for Invasive Mechanical Ventilation ("IMV”) or Extracorporeal Membrane Oxygenation (“ECMO”).

CytoDyn Inc. (OTCQB: CYDY) ("CytoDyn" or the "Company"), a late-stage biotechnology company developing leronlimab, a CCR5 antagonist with the potential for multiple therapeutic indications, announced today additional preliminary results to date from the 20 patients who have completed the open-label portion of the Phase 2 trial for NASH (Nonalcoholic steatohepatitis).

CytoDyn Inc. (OTCQB: CYDY) (“CytoDyn” or the “Company”), a late-stage biotechnology company developing leronlimab, a CCR5 antagonist with the potential for multiple therapeutic indications, today announced that it has submitted a Phase 3, randomized, double blind, placebo controlled trial with the U.S. Food and Drug Administration (“FDA”) to evaluate the efficacy and safety of leronlimab in combination with standard of care for critically ill patients with COVID-19 pneumonia with need for invasive mechanical ventilation ("IMV”) or Extracorporeal Membrane Oxygenation (“ECMO”).

CytoDyn Inc. (OTCQB: CYDY) (“CytoDyn” or the “Company”), a late-stage biotechnology company developing leronlimab, a CCR5 antagonist with the potential for multiple therapeutic indications, today filed a request with the U.S. Food and Drug Administration (“FDA”) for approval of expanded access use of leronlimab for multi-drug resistance (MDR) HIV patients. The Company has also previously sought FDA approval for CytoDyn to charge for leronlimab used in this patient population and is preparing to file the last portion of this request.

CytoDyn Inc. (OTCQB: CYDY) (“CytoDyn” or the “Company”), a late-stage biotechnology company developing leronlimab, a CCR5 antagonist with the potential for multiple therapeutic indications, today announced that its CRO in Brazil (Academic Research Organization (ARO) Albert Einstein Israelite Hospital (AEIH)) met with the Brazilian Health Regulatory Agency (ANVISA) and received its agreement to modify the CD16 trial for critically ill COVID-19 patients. ANVISA has authorized CytoDyn to submit the requested changes. CytoDyn will submit the revised protocol for CD16 providing for a reduction in total enrollment from 330 to 126 patients, with interim efficacy analysis by DSMB after 40% of patients (51 patients) are enrolled and have completed follow-up to Day 28.

CytoDyn Inc. (OTCQB: CYDY) (“CytoDyn” or the “Company”), a late-stage biotechnology company developing leronlimab, a CCR5 antagonist with the potential for multiple therapeutic indications, today announced it has completed submission of all the major sections of CMC modules to FDA, some remaining supporting documentation will be submitted under Regional Information before the end of this week. CMC is a critical part of CytoDyn’s Biologics License Application (“BLA”) for HIV. This submission was made under rolling review consistent with guidance from the U.S. Food and Drug Administration (“FDA”). Only the clinical section remains to be submitted.

CytoDyn Inc. (OTCQB:CYDY) (“CytoDyn” or the “Company”), a late-stage biotechnology company developing leronlimab, a CCR5 antagonist with the potential for multiple therapeutic indications, reminded investors that Dr. Scott Kelly, CytoDyn’s Chairman of the Board, Chief Medical Officer and Head of Business Development, will present at the World Antiviral Congress being held tomorrow, November 30, 2021 through Thursday, December 2, 2021.

CytoDyn Inc. (OTCQB: CYDY) (“CytoDyn” or the “Company”), a late-stage biotechnology company developing leronlimab, a CCR5 antagonist with the potential for multiple therapeutic indications, today reported data from its trial treating NASH (nonalcoholic steatohepatitis) open label with leronlimab.

CytoDyn Inc. (OTCQB: CYDY) (“CytoDyn” or the “Company”), a late-stage biotechnology company developing leronlimab, a CCR5 antagonist with the potential for multiple therapeutic indications, today announced that its research paper entitled “CCR5 receptor occupancy analysis reveals increased peripheral blood CCR5+CD4+ T cells following treatment with the anti-CCR5 antibody Leronlimab” has been accepted by Frontiers in Immunology, a leading journal in its field publishing rigorously peer-reviewed research across basic, translational and clinical immunology.

CytoDyn Inc. (OTCQB: CYDY) (“CytoDyn” or the “Company”), a late-stage biotechnology company developing leronlimab, a CCR5 antagonist with the potential for multiple therapeutic indications, today announced that Health Canada authorized the emergency use of leronlimab for the treatment of a patient with metastatic triple-negative breast cancer (mTNBC).

CytoDyn Inc. (OTCQB: CYDY) (the “Company”), a late-stage biotechnology company developing leronlimab, a CCR5 antagonist with the potential for multiple therapeutic indications, today convened and then adjourned the 2021 Annual Meeting of Shareholders (the “Annual Meeting”) without transacting any other business. The Annual Meeting was adjourned to be held virtually on Wednesday, November 24, 2021 at 8:00 a.m. Pacific Time. The adjournment provides the Company with additional time to solicit proxies from its shareholders to achieve a quorum at the Annual Meeting.

CytoDyn Inc. (OTCQB: CYDY) (“CytoDyn” or the “Company”), a late-stage biotechnology company developing leronlimab, a CCR5 antagonist with the potential for multiple therapeutic indications, today announced the Delaware Court of Chancery has denied a motion by the activist group led by Paul Rosenbaum and Bruce Patterson (the “Activist Group”) to prevent the Company’s 2021 Annual Meeting of Stockholders (the “Annual Meeting”) from taking place as scheduled on October 28, 2021.

CytoDyn Inc. (OTCQB: CYDY) (“CytoDyn” or the “Company”), a late-stage biotechnology company developing leronlimab, a CCR5 antagonist with the potential for multiple therapeutic indications, today announced that shareholders will receive proxy material beginning this week from the Company in connection with its upcoming 2021 Annual Meeting of Stockholders on October 28, 2021 (the “Annual Meeting”).

CytoDyn Inc. (OTCQB: CYDY) (“CytoDyn” or the “Company”), a late-stage biotechnology company developing leronlimab, a CCR5 antagonist with the potential for multiple therapeutic indications, today announced that the Delaware Court of Chancery found that CytoDyn’s Board of Directors properly rejected a nomination notice presented by an activist group led by Paul Rosenbaum and Bruce Patterson (the “Rosenbaum/Patterson Group” or the “Activist Group”). All of the Activist Group’s claims were denied and judgment was entered for CytoDyn and its Board.

CytoDyn Inc. (OTCQB: CYDY) (“CytoDyn” or the “Company”), a late-stage biotechnology company developing leronlimab, a CCR5 antagonist with the potential for multiple therapeutic indications, today responded to the “plan” put forward by an activist group led by Paul Rosenbaum and Bruce Patterson (the “Rosenbaum/Patterson Group” or the “Activist Group”):

CytoDyn Inc. (OTCQB: CYDY) ("CytoDyn" or the "Company"), a late-stage biotechnology company developing leronlimab, a CCR5 antagonist with the potential for multiple therapeutic indications, announced today Nader Pourhassan, Ph.D., President and Chief Executive Officer and Scott Kelly, M.D., Chairman, Chief Medical Officer and Head of Business Development of CytoDyn will provide a comprehensive business update at the upcoming Emerging Growth Conference. CytoDyn will present for 20 minutes, and 40 minutes will be dedicated to live questions and answers.

CytoDyn Inc. (OTCQB: CYDY) (“CytoDyn” or the “Company”), a late-stage biotechnology company developing leronlimab, a CCR5 antagonist with the potential for multiple therapeutic indications, today announced that Brazil’s regulatory authority, ANVISA (Agência Nacional de Vigilância Sanitária), has approved the start of an additional Phase 3 CD16 clinical trial of leronlimab.

CytoDyn Inc. (OTCQB: CYDY) (“CytoDyn” or the “Company”), a late-stage biotechnology company developing leronlimab, a CCR5 antagonist with the potential for multiple therapeutic indications, today announced that Dr. Scott Kelly, CytoDyn’s Chairman of the Board, Chief Medical Officer and Head of Business Development, will be presenting at the World Antiviral Congress 2021. The Congress will be held from November 30 – December 2, 2021, in San Diego.

The Board of Directors (the “Board”) of CytoDyn Inc. (OTCQB: CYDY) (“CytoDyn” or the “Company”), a late-stage biotechnology company developing leronlimab, a CCR5 antagonist with the potential for multiple therapeutic indications, today announced the resolution of its lawsuit (the “Federal Lawsuit”) brought in the United States District Court for the District of Delaware against the activist group led by Paul Rosenbaum and Bruce Patterson (the “Rosenbaum/Patterson Group” or the “Activist Group”).

The Board of Directors (the “Board”) of CytoDyn Inc. (OTCQB: CYDY) (“CytoDyn” or the “Company”), a late-stage biotechnology company developing leronlimab, a CCR5 antagonist with the potential for multiple therapeutic indications, today issued a statement to shareholders commenting on the Court Order entered yesterday by a United States District Court Judge in the lawsuit brought by CytoDyn against the activist group led by Paul Rosenbaum and Bruce Patterson (the “Rosenbaum/Patterson Group,” the “Activist Group”).

The Board of Directors (the “Board”) of CytoDyn Inc. (OTCQB: CYDY) (“CytoDyn” or the “Company”), a late-stage biotechnology company developing leronlimab, a CCR5 antagonist with the potential for multiple therapeutic indications, today issued the following statement regarding the continued efforts of an activist group led by Paul Rosenbaum and Bruce Patterson (the “Rosenbaum/Patterson Group” or the “Group”) to mislead shareholders and engage in an unlawful proxy contest to replace a majority of the Company’s Board.

CytoDyn Inc. (OTCQB: CYDY) (“CytoDyn” or the “Company”), a late-stage biotechnology company, today announced that it has filed a lawsuit in the United States District Court for the District of Delaware against the activist group led by Paul Rosenbaum and Bruce Patterson (the “Rosenbaum/Patterson Group” or the “Activist Group”). The suit seeks to enjoin the Activist Group from misleading shareholders and waging an illegal proxy contest to take over control of the Company’s Board of Directors (the “Board”).

CytoDyn Inc. (OTCQB: CYDY) ("CytoDyn" or the "Company"), a late-stage biotechnology company developing leronlimab, a CCR5 antagonist with the potential for multiple therapeutic indications, announced today that Brazil’s regulatory authority ANVISA (Agência Nacional de Vigilância Sanitária) has approved the previously submitted clinical trial protocol to commence patient enrollment in its CD17 trial for severe COVID-19 patients. The Academic Research Organization (ARO) Albert Einstein Israelite Hospital (AEIH) in Brazil will conduct the trial.

CytoDyn Inc. (OTCQB: CYDY) (“CytoDyn” or the “Company”), a late-stage biotechnology company, announced today that the director nominations submitted by an activist group led by Paul Rosenbaum and Bruce Patterson (the “Rosenbaum/Patterson Group”) were invalid. The Rosenbaum/Patterson Group attempted to nominate five director candidates to take over control of the Company’s six-member Board of Directors (the “Board”).