Leronlimab

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

Retrieved on: 
Thursday, February 1, 2024
Partnership, Glioblastoma, Inflammation, Research, OTCQB, Montefiore Medical Center, HIV, Leronlimab, Patient, Splenic infarction, Stroke, FDA, Biotechnology, CCR5, Pharmaceutical industry

The Company believes this submission will lead to the removal of the clinical hold currently in effect.

Key Points: 
  • The Company believes this submission will lead to the removal of the clinical hold currently in effect.
  • CytoDyn’s CEO, Dr. Jacob Lalezari stated, “Our HIV protocol has been revised and resubmitted following FDA input, and will study leronlimab in HIV patients who have increased inflammation and immune activation, which causes heart attacks, strokes, and other vascular events.
  • Glioblastoma is a common and often untreatable form of primary brain cancer.
  • CytoDyn is fortunate to be able to evaluate the potential effects of leronlimab in a pre-clinical model of this all too often deadly cancer.”

November 2023 Letter to Shareholders

Retrieved on: 
Friday, November 3, 2023
FDA, Policy, Compensated emancipation, G&A, HIV, Workforce, Injection, Leronlimab, Sidley Austin, Drug development, Professional Football Compensation Committee, Clinical trial, Compensation, Partnership, Consultant, Benchmarking, FAQ, FBI investigation into Donald Trump's handling of government documents, Annual report, IP, Patient, MASH, Hearing, Lifting, Communication, Security (finance), Pharmaceutical industry, Retail, Management

If successful, our current team stands ready to implement the best strategies to maximize shareholder value in the near- and long-term.

Key Points: 
  • If successful, our current team stands ready to implement the best strategies to maximize shareholder value in the near- and long-term.
  • The Company recently provided additional information to the FDA that we believe answers the FDA’s remaining questions.
  • Accordingly, each fiscal year, the shareholders are asked to place an advisory vote as to the compensation of our executive officers.
  • Risk Factors”, as later supplemented by our Form 10-Q for the quarter ended August 31, 2023, in the section captioned “Item 1A.

CytoDyn Announces Company Updates and Investment Community Update Webcast

Retrieved on: 
Tuesday, July 11, 2023
American Arbitration Association, Failure, Business operations, Clinical trial, OTCQB, District court, Action Replay, Hearing, Contract research organization, Chairperson, CCR5, Knowledge, FDA, Leronlimab, Douglas v. U.S. District Court ex rel Talk America, SVP, Chair, Pharmaceutical industry, Webcast

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. A search has begun for a new President and/or Chief Executive Officer, while Antonio Migliarese, the Company’s Chief Financial Officer, will continue to serve as interim President.

Key Points: 
  • Amarex provided clinical trial management and regulatory services to CytoDyn from 2013 to 2021.
  • Should the Company prevail at the final hearing, the Company will be entitled to recover its damages and legal fees incurred from Amarex.
  • Due to Amarex’s failures, the Company suffered substantial damages and will be seeking an award in excess of $100 million at the final hearing.
  • Although the Board has commenced a search for a President and/or CEO, the current team is beyond well-equipped.”
    The Company will host the following live webcast to provide a Company update:

CytoDyn Announces Appointment of Additional Directors with Industry Experience

Retrieved on: 
Thursday, October 20, 2022
Risk management, U.S. Securities and Exchange Commission, CFO, Infection, SEC, Growth, AbbVie, CCR5, LLC, COO, Biotechnology, Patient, Research, Security (finance), KPMG, Risk, Leronlimab, Cancer, Form 10-K, Company, Industry, Mab, Board, KPMG LLP, CEO, Business development, Leadership, GLOBE, Board of directors, PricewaterhouseCoopers, LLP, OTCQB, Immunoglobulin G, Compliance, Moss Adams, Management

VANCOUVER, Wash., Oct. 20, 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, today announced additional changes in its Board of Directors (the “Board”). Mr. Stephen Simes, a career public company biotech CEO, was appointed to the Board effective October 13, 2022. Mr. Ryan Dunlap, a current CFO with public company biotech experience, was appointed to the Board effective August 25, 2022. Mr. Simes and Mr. Dunlap join the Board as independent directors of the Company. Also, concurrently with the appointment of Mr. Simes, Dr. Scott Kelly resigned as a director. Dr. Kelly will continue to serve as the Company’s Chief Medical Officer and Head of Business Development. The Board now has five directors, all of whom are independent directors.

Key Points: 
  • Mr. Ryan Dunlap, a current CFO with public company biotech experience, was appointed to the Board effective August 25, 2022.
  • Mr. Simes and Mr. Dunlap join the Board as independent directors of the Company.
  • Also, concurrently with the appointment of Mr. Simes, Dr. Scott Kelly resigned as a director.
  • Cyrus Arman, Ph.D., President of CytoDyn, stated, The appointments of Mr. Simes and Mr. Dunlap further enhance the independence of our Board and add to its biotechnology industry experience.

CytoDyn Appoints Cyrus Arman, Ph.D., MBA, as President

Retrieved on: 
Wednesday, July 13, 2022
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VANCOUVER, Washington, July 13, 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, today announced the appointment of Dr. Cyrus Arman as President effective July 9, 2022.

Key Points: 
  • VANCOUVER, Washington, July 13, 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, today announced the appointment of Dr. Cyrus Arman as President effective July 9, 2022.
  • It is anticipated that he will advance to Chief Executive Officer and be appointed to the Board of Directors within six months.
  • Antonio Migliarese, who had been serving as interim President since late January, in addition to CFO, will resume his previous role as CFO.
  • CytoDyn is studying leronlimab in multiple therapeutic areas, including infectious disease, cancer, and autoimmune conditions.

CytoDyn Highlights NIH Grant for HIV Functional Cure Preclinical Study of Gene Therapy Based on Leronlimab

Retrieved on: 
Monday, July 11, 2022
Safety, HIV, Partnership, School of Life Sciences (University of Dundee), Infection, FDA, Mab, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Primate, Form 10-K, ART, Optimism, CEO, Securities and Exchange Commission (Philippines), 100,000, Risk, Immunoglobulin G, Oregon Health & Science University, OTCQB, Art therapy, Degenerative disease, Social conditioning, Cas9, Food, Therapy, National Institute, Company, Forward-looking statement, National, Cell, AAV, Compliance, OHSU, CCR5, Cancer, Vaccine, GLOBE, Research, Patient, Liver disease, XV, Poverty, Security (finance), Clinical trial, NIH, Pharmaceutical industry, Leronlimab

VANCOUVER, Washington, July 11, 2022 (GLOBE NEWSWIRE) --  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 a new, preclinical study in nonhuman primates that will evaluate the potential use in HIV of a gene therapy based on the experimental monoclonal antibody leronlimab.

Key Points: 
  • The grant will fund the development and preclinical research of a single-injection gene therapy that codes for the leronlimab protein sequence and which will be delivered via an adeno-associated virus (AAV) vector.
  • Leronlimab has demonstrated it can pharmacologically mimic a CCR5 deficient donor by occupying available CCR5 molecules.1 Leronlimab is a protein, and the goal of the research at OHSU is to create a gene therapy that expresses the gene encoding the leronlimab protein.
  • Jacob Lalezari, M.D., Scientific Advisor to CytoDyn, stated, The potential for a one-time gene therapy encoding a protein such as leronlimab represents a great hope for the future of HIV therapy and functional cure.
  • Gene therapy consisting of the gene for an anti-HIV antibody carried by an AAV vector holds promise for long-term control of HIV.

CytoDyn Announces Publication of Peer-Reviewed Paper, “Suppression of Human and Simian Immunodeficiency Virus Replication with the CCR5-Specific Antibody Leronlimab in Two Species”

Retrieved on: 
Tuesday, April 12, 2022
CEO, XV, Clinical trial, Northwestern Health Sciences University, HIV, U.S. Securities and Exchange Commission, Security (finance), Risk, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, SHIV, Food, Compliance, GLOBE, CCR5, Patient, Immunoglobulin G, 100,000, Form 10-K, Simian immunodeficiency virus, Infection, PLOS Pathogens, Oregon Health & Science University, Company, OTCQB, Vaccine, Social conditions in Honduras, Forward-looking statement, Optimism, Mab, Partnership, FDA, Cancer, Pharmaceutical industry, Leronlimab

The study followed five HIV+ human participants who, after successfully transitioning to once weekly subcutaneous leronlimab, halted their previous daily oral antiretroviral therapy regimens.

Key Points: 
  • The study followed five HIV+ human participants who, after successfully transitioning to once weekly subcutaneous leronlimab, halted their previous daily oral antiretroviral therapy regimens.
  • These five participants came from an extension study, consisting of patients who were virologically suppressed in a prior study of leronlimab.
  • All five long-term participants successfully maintained HIV suppression via leronlimab monotherapy for over seven years, with no evidence of viral escape.
  • To monitor the anatomical penetrance of leronlimab, rhesus macaques acutely infected with simian human immunodeficiency virus (SHIV) were treated with high intravenous doses of leronlimab for 12 weeks.

CytoDyn Announces Partial Clinical Hold of HIV Program and Full Clinical Hold of COVID-19 Program

Retrieved on: 
Wednesday, March 30, 2022
Optimism, Company, Form 10-K, 100,000, Partnership, Risk, Forward-looking statement, Social conditions in Honduras, Clinical trial, Compliance, Vaccine, XV, CCR5, Mab, Cancer, CEO, Food, Securities and Exchange Commission (Philippines), Infection, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, HIV, FDA, Immunoglobulin G, Patient, Security (finance), Pharmaceutical industry, Leronlimab

VANCOUVER, Washington, March 30, 2022 (GLOBE NEWSWIRE) -- 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 that the U.S. Food and Drug Administration (FDA) has placed a partial clinical hold on its HIV program and a full clinical hold on its COVID-19 program in the United States. Further, the Company elected to pause its Brazil COVID-19 trials pending results from its previously scheduled data safety monitoring committee meeting and is in the process of reevaluating the timing of its HIV BLA resubmission.

Key Points: 
  • Cytodyn is studying leronlimab in multiple therapeutic areas, including infectious disease, cancer, and autoimmune conditions.
  • This press release contains certain forward-looking statements that involve risks, uncertainties and assumptions that are difficult to predict.
  • Forward-looking statements specifically include statements about leronlimab, the Company's ability to resolve the clinical holds recently imposed by the FDA, leronlimab's safety and effectiveness, and the Company's ability to obtain regulatory approval for commercial sales.
  • 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.

CYTODYN TECHNOLOGIES INVESTIGATION INITIATED by Former Louisiana Attorney General: Kahn Swick & Foti, LLC Investigates the Officers and Directors of CytoDyn Inc. - CYDY

Retrieved on: 
Saturday, March 19, 2022
Legal, Professional Services, Company, Survival rate, Food, LLC, Safety, KSF, COVID-19, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, HIV, OTC, Patient, Pharmaceutical industry, Leronlimab

Former Attorney General of Louisiana, Charles C. Foti, Jr., Esq., a partner at the law firm of Kahn Swick & Foti, LLC (KSF), announces that KSF has commenced an investigation into CytoDyn Inc. (OTC: CYDY).

Key Points: 
  • Former Attorney General of Louisiana, Charles C. Foti, Jr., Esq., a partner at the law firm of Kahn Swick & Foti, LLC (KSF), announces that KSF has commenced an investigation into CytoDyn Inc. (OTC: CYDY).
  • The Company has been sued in a securities class action lawsuit for failing to disclose material information, violating federal securities laws, which remains ongoing.
  • KSFs investigation is focusing on whether CytoDyns officers and/or directors breached their fiduciary duties to the Companys shareholders or otherwise violated state or federal laws.
  • About Kahn Swick & Foti, LLC
    KSF, whose partners include former Louisiana Attorney General Charles C. Foti, Jr., is one of the nations premier boutique securities litigation law firms.

CytoDyn Cancels Webcast and Live Q/A Scheduled for Today

Retrieved on: 
Thursday, January 13, 2022
Oncology, AIDS, Health, Infectious Diseases, Pharmaceutical, Biotechnology, Biomarker, Calendar, Forward-looking statement, HIV, Patient, Fatty liver disease, HIV/AIDS, Human, Vaccine, Inflammation, Clinical trial, Government budget balance, Fast Track, OTCQB, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Form 10-K, BLA, COVID-19, Social conditions in Honduras, ME/CFS, Partnership, SARS, Optimism, Cirrhosis, XV, Triple-negative breast cancer, CCR5, Refusal, Standard of care, Common, NASH, Securities and Exchange Commission (Philippines), Sleep, PASC, Fatigue, HAART, Myalgia, Degenerative disease, Company, Viral load, Food, Fibrosis, NAFLD, Biologics license application, FDA, 100,000, Cell, Compliance, Security (finance), Immunoglobulin G, Risk, Pharmaceutical industry, R5, 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, announced it has canceled its webcast scheduled for today, Thursday, January 13, 2022 and will provide an update at a future date.

Key Points: 
  • 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.
  • Leronlimab does not work on other strains of HIV (for example X4), however, R5 is the most dominant strain of HIV.
  • About 30 to 40 percent of adults in the U.S. live with NAFLD, and 3 to 12 percent of adults in the U.S. live with NASH.
  • CytoDyn also completed a Phase 2b/3 investigative trial with leronlimab used as a once-weekly monotherapy for HIV-infected patients.