CYTODYN - Key Persons
Job Titles:
- Member of the Board of Directors
- Vice President of Operations
Dr. Cunningham, a certified Project Management Professional with extensive experience in development of investigational medicinal products (IMP) including solid oral dosage forms, cell therapies, radiopharmaceuticals and monoclonal antibodies, joined CytoDyn as Executive Director of Supply Chain and Project Management in June 2020 and was promoted to Vice President of Supply Chain and Project Management in 2021. Prior to joining the Company, she held positions of increasing responsibilities at OSI Pharmaceuticals, Mesoblast and Actinium Pharmaceuticals. She possesses extensive knowledge of pharmaceutical product development and has expertise in establishing systems and processes in growing companies. Dr. Cunningham received her B.Sc. degree in Pharmacy and Ph.D in Medicinal Chemistry from Aston University and is a Member of the Royal Pharmaceutical Society of Great Britain.
Job Titles:
- Member of the Board of Directors
- SVP, Business Operations
Dr. Arman joined CytoDyn in July 2022 having previously held positions with a number of biotechnology companies, and most recently serving as Chief Business Officer of Nimble Therapeutics, Inc., a company focused on engineering peptides. Prior to Nimble he was Vice President of Corporate Development and Strategy of NEUVOGEN, Inc., an immuno-oncology company developing therapeutic whole cell cancer vaccines, from 2019 until 2021. Beginning in 2017, he served as co-founder and managing partner of BioVega Capital, LLC, a life sciences hedge fund. From 2014-2019 he served in a variety of strategy roles at Amgen, a leading independent biotechnology company, including as Director of Corporate Strategy and Global Director and Head of Competitive Intelligence and Strategy. Prior to Amgen he was a Principal at Deallus Consulting, a global lifesciences competitive strategy consulting firm. He received an M.S. degree in biomedical engineering and a Ph.D. in neuroscience from the University of Southern California and an M.B.A from the UCLA Anderson School of Management.
Job Titles:
- Director of the Breast Oncology Clinical Trials Program at UCSF
Dr. Hope Rugo is the Director of the Breast Oncology Clinical Trials Program at UCSF. She is the principal investigator for multiple clinical trials studying novel targeted therapeutics combined with standard treatments to improve clinical results in early and late-stage breast cancer. She is also researching cognitive function in patients receiving chemotherapy for breast cancer as well as ways to reduce toxicity from therapy.
Job Titles:
- CEO
- Member of the Board of Directors
Appointed to CEO in January 2024, Dr. Lalezari brings over 34 years of industry experience to the Company, including nearly 20 years of experience with leronlimab, also known as PRO 140. He previously served as interim CEO of CytoDyn from November 2023 to January 2024, Chief Medical Officer during 2020, and has been a member of the Company's scientific advisory board for the past several years. Dr. Lalezari has been the CEO and Medical Director of Quest Clinical Research since 1996, and served as the Chief Medical Officer of Virion Therapeutics in 2018. Dr. Lalezari has served as Principal Investigator for Phase I, II, and III clinical studies of new therapies for such viral diseases as HIV/AIDS, CMV, HPV, HSV, Hepatitis B and C, influenza, RSV, and COVID-19, including clinical trials conducted by the Company. His work has been published extensively and he is a well-regarded international speaker and patient advocate. Dr. Lalezari received his M.D. from the University of Pennsylvania, his M.A. from the University of Virginia, and his B.A. from the University of Rochester. He also holds a board certification from the American Board of Internal Medicine.
Job Titles:
- Medical Director at IMV, Inc
Dr. Kabir Mody is the Medical Director at IMV, Inc. and a board-certified medical oncologist. He brings a wealth of experience and knowledge in oncology and immuno-oncology accumulated while working at Mayo Clinic as an academic oncologist focused on GI oncology, in particular cancers of the liver and the pancreas. Dr. Mody received his MD from St. George's University School of Medicine, completed his residency at St. Luke's-Roosevelt Hospital in New York City and fellowship at Dartmouth Hitchcock Medical Center in New Hampshire. He has co-authored numerous papers and book chapters, including many on the biology and novel treatment strategies of liver and pancreas malignancies, and has been actively involved in leading both clinical and lab-based research on cancers of the liver and pancreas.
Dr. Eric Mininberg is a board-certified medical oncologist at Piedmont Cancer Institute and a Diplomat of the American Board of Internal Medicine. He graduated from Dartmouth College in 1993 with a degree in government and obtained a medical degree from the University of Virginia School of Medicine. He completed his residency at the University of Virginia Medical Center. He was a Hematology fellow at Baylor University and a Medical Oncology fellow at the University of Texas MD Anderson Cancer Center.
Dr. Mininberg is the recipient of numerous honors and awards. He was inducted in 1989 as a member of Cum Laude Society with St. Albans School in Washington, DC. While at The University of Texas MD Anderson Cancer Center, he was honored with the Elsa U. Pardee Foundation Grant for Community Oncology. As a fellow in 2003 he was awarded the American Society of Clinical Oncology Merit Award. He holds memberships with the Dartmouth and University of Virginia Alumni Associations, as well as the American and Georgia Societies of Clinical Oncology.
Dr. Sacha graduated cum laude from the University of Missouri-Columbia in 2003 with a B.A. in German and B.S. in Biology. After receiving his Ph.D. in Medical Microbiology & Immunology from the University of Wisconsin-Madison in 2007, he joined the faculty at UW-Madison, where he researched the characteristics of effective retrovirus-specific CD8+ and CD4+ T cells. In 2011, he joined the Oregon Health & Science University and has appointments in both the Vaccine & Gene Therapy Institute and Oregon National Primate Research Center.
Job Titles:
- Associate Professor of Medicine With Tenure
Dr. Lake is Associate Professor of Medicine with Tenure at UTHealth McGovern Medical School. She completed both medical school and Internal Medicine residency at Baylor College of Medicine in Houston, Texas, followed by an Infectious Diseases fellowship and Master of Science in Clinical Research degree program at the University of California, Los Angeles. Dr. Lake's outpatient practice focuses on adults living with HIV, and gender care for transgender women with HIV. Her translational research portfolio focuses on the treatment of metabolic complications of HIV and antiretroviral therapy, with particular expertise in translational clinical trials. Dr. Lake also serves leadership positions in the NIH-funded MACS/WIHS Combined Cohort Study and AIDS Clinical Trials Group.
Job Titles:
- Member of the Board of Directors
- Executive Director, Clinical Operations
Mr. Meidling joined CytoDyn in March of 2021 as Senior Director of Portfolio and Project Management and in May of 2022 was appointed Senior Director of Clinical Operations. Prior to joining CytoDyn, Mr. Meidling spent nearly 22 years at Merck where he held various positions of increasing responsibilities in Drug Development. He was a director in Clinical Pharmacology and Translational Medicine and led the Pharmacogenomics and Biorepository group before moving on to become the site lead for Merck's Kenilworth facility and was responsible for Merck's Early-Stage Development portfolio and resource planning. Mr. Meidling has a BS in Engineering from New Jersey Institute of Technology and an MBA from Montclair State University.
Job Titles:
- Director
- Member of the Compensation Committee
- Compensation
Dr. Brunke has over 30 years of scientific, operational, clinical, senior executive, and corporate development managerial experience with large and small biotechnology companies. She is currently the Executive Vice President of Corporate and Business Development at Jaguar Health, Inc. (NASDAQ: JAGX). Previously, Dr. Brunke was part of the executive team that merged Mercator Genetics Inc. with Progenitor, a subsidiary of Interneuron Pharmaceuticals, in 1999 and helped take the resulting company public. Dr. Brunke was Chief Operating Officer of Anexus Pharmaceuticals, a subsidiary of the Japanese public company MediBic, responsible for in- and out-licensing assistance for Japanese companies, and was founding Chief Executive Officer of Cardeus Pharmaceuticals, a neuroscience company. Dr. Brunke received her BA in Biochemistry as well as a Ph.D. in Microbiology from the University of Pennsylvania and did postdoctoral studies at the Institute for Cancer Research in Fox Chase.
Job Titles:
- Director
- Member of the Nominating and Corporate Governance Committee
- Nominating and Corporate Governance
Appointed to Weill Cornell Medicine in 2019 as Professor of Immunology in Medicine and Neuroscience, Dr. Ndhlovu has served on the Company's Scientific Advisory Board since July 2020. Before joining Weill Cornell Medicine, Dr. Ndhlovu was a Professor at the University of Hawaii from 2011 to 2019, where he retains an adjunct appointment. As Co-leader of the $26.5 million NIH-Martin Delaney Collaboratory for HIV Cure "HOPE.", he is a recognized expert in basic and complex immunology and immunotherapy research. He has focused much of his work on confronting the challenges of HIV and aging, addressing molecular mechanism of HIV and COVID-19 pathogenesis, complications and persistence. Dr. Ndhlovu received his M.D. from the University of Zambia and his Ph.D. from Tohoku University in Japan and is an elected Fellow of the American Academy of Microbiology. He brings a deep understanding of the central nervous system aspects of HIV and research expertise in major arenas in which the Company is conducting clinical trials of its drug product candidate.
Job Titles:
- Director of the Houston Liver Institute
Dr. Noureddin is the current Director of the Houston Liver Institute and former founding Director of the Fatty Liver Program at Cedars-Sinai. He completed his residency at the University of Southern California and completed a hepatology fellowship at the NIH and gastroenterology fellowship at University of California San Diego.
Dr. Noureddin has led efforts in several breakthrough clinical trials targeting new therapies in patients with non-alcoholic fatty liver disease (NAFLD) and non-alcoholic steatohepatitis (NASH), including those with advanced fibrosis and cirrhosis. He also focuses on the underlying mechanisms of non-alcoholic fatty liver disease (NAFLD) and non-alcoholic steatohepatitis (NASH), liver transplant, liver cancer, new imaging modalities, and exploring new treatments.
Dr. Noureddin has conducted more than 40 investigational clinical studies of novel treatments for non-alcoholic steatohepatitis (NASH). Dr. Noureddin has published 180 papers in the field of NASH in many journals including: The Lancet, Lancet Gastroenterology & Hepatology, Science Trinational Medicine, Gastroenterology, Journal of Hepatology, Journal of Clinical Investigation, Hepatology, Clinical Gastroenterology and Hepatology and others.
Job Titles:
- Member of the Board of Directors
- Interim CFO
As of February 1, 2024, Mr. Cohen is serving as interim CFO of the Company. Mr. Cohen has more than 30 years of financial, operations and general business experience as a senior financial and operations executive at various public and private companies and has extensive expertise in all SEC and public company matters. Mr. Cohen also has experience in public accounting with an emphasis on financial audits of hedge funds and mergers and acquisitions engagements. Prior to joining CytoDyn, Mr. Cohen served as interim Chief Financial Officer for several NASDAQ-listed companies, including Blue Apron Holdings, Inc., Redbox Entertainment, Inc., and Cerence Inc. Before that, he was a consulting Chief Financial Officer for various companies, and served as CFO of Athenian Venture Partners, a venture capital firm specializing in early-stage investments in information technology, healthcare, and digital health. Prior roles also include interim senior Chief Financial Officer at CIFC LLC; C-level roles at S2BN Entertainment, Inc.; and, Chief Financial Officer and Secretary of Asta Funding, Inc. Mr. Cohen graduated from Queens College with a bachelor's degree in accounting and economics.
Job Titles:
- Professor of Medicine at the University of Texas MD Anderson Cancer Center
Dr. Ueno is a Professor of Medicine at The University of Texas MD Anderson Cancer Center. He is the Executive Director of the Morgan Welch Inflammatory Breast Cancer Program and Clinic and Section Chief of the Translational Breast Cancer Research at the Department of Breast Medical Oncology. His research is in the area of inflammatory breast cancer/triple-negative breast cancer. In particular, he focuses on the molecular mechanism of metastasis and tumorigenicity driven by cancer microenvironment.
Dr. Ueno is best known for his preclinical/clinical development for E1A, EGFR, HER2, MAPK pathway targeting therapy leading to novel clinical trials. His research determined the immune response that predicts sensitivity to anti-epidermal growth factor receptor (EGFR) therapy for inflammatory breast cancer (IBC) and developed novel treatment strategies by modulating the IBC microenvironment. He has conducted numerous phase 1/2 clinical trials of targeted therapy in patients with aggressive breast cancer.
Dr. Otto Yang is a Professor of Medicine, Infectious Diseases, Microbiology, Immunology & Molecular Genetics at UCLA and has a background in clinical infectious diseases. His laboratory specializes in T cell immunology in HIV infection, relevant to developing immune therapies and vaccines for HIV and potentially other diseases including cancer and other viral infections. He received his MD degree from Brown University, with subsequent residency training at NYU-Bellevue Hospital and subspecialty/postdoctoral training at Harvard-Massachusetts General Hospital. He then pursued fellowship at Massachusetts General Hospital, where he developed a research program studying the role of CD8+ T lymphocytes (CTL, which are killer T cells that can destroy cells infected with viruses or which are malignant) in HIV-1 pathogenesis. A more recent research interest has been the role of CTL in the development of rejection in organ transplant patients. Dr. Yang has begun working with the new composite tissue transplantation program at UCLA, which will perform hand and face transplants, studying the role of this arm of immunity in causing tissue rejection. Dr. Yang is a frequent lecturer, received numerous research grants and funding for his work, published over 180 peer-reviewed articles, and holds numerous patents in HIV and Immunology.
Job Titles:
- Director
- Member of the Audit Committee
- Member of the Nominating and Corporate Governance Committee
- Audit
Mr. Dunlap has over 25 years' experience in finance and operations leadership, developing significant expertise in strategy setting, improving operational efficiency and effectiveness, fundraising and investor relations, financial reporting and compliance, and risk management. Prior to joining Gurobi, he spent 3.5 years as the CFO and COO for a growth equity backed molecular diagnostics company, where he helped more than double enterprise value over a 4-year period through profitability improvement and a new product launch, supporting a successful exit through acquisition. Prior to that he served for 4 years as the CFO of a publicly traded biotechnology and pharmaceutical sales company, where he helped raise over $150 million to fund 300% growth from pipeline expansion and new product acquisition and launched and supported the company's investor reporting and SEC compliance function. Earlier in his career, Mr. Dunlap held various financial and operational leadership roles in large, multinational organizations, and spent 11 years with public accounting firms such as PwC, KPMG, and Moss Adams, where he provided business assurance and advisory services to large and small, public, and private companies predominately in the software, technology and life science industries. Mr. Dunlap earned a B.S. degree in Accounting from the University of Oregon and is a licensed and active CPA in the state of Oregon.
Job Titles:
- Member of the Board of Directors
- Head of Research & Basic Science
Dr. Hansen has 25 years of experience in the field of virology and immunology, 17 of which were focused on the development and utilization of the non-human primate (NHP) model for the study of host vs. pathogen interactions, disease state modeling, and vaccine development. He is currently an Associate Professor at OHSU, where he has earned recognition for his strong publication record. The majority of this published work focused on the development of a novel vaccine platform based on Cytomegalovirus. To support the translation of this vector platform to clinical development and to provide sample intake functions for clinical trial endpoint analysis, Dr. Hansen developed a Human Samples Laboratory that operates in accordance with Good Clinical Laboratory Practices (GCLP), as well as a Quality System to provide appropriate regulation for documents, data, and inventory. He will draw upon this experience and expertise in his role at CytoDyn, where he will provide research support for method of action and assay support for clinical trials. Dr. Hansen's research laboratory has been studying leronlimab since the Spring of 2021. In this time he has developed numerous flow cytometry biomarker assays to investigate how leronlimab/CCR5 modulates various immune cell phenotypes. Additionally, he developed an exploratory CCR5 receptor occupancy assay to evaluate leronlimab binding/loading after dosing. Dr. Hansen's work has led to two research publications (one pending publication) that has already furthered CytoDyn's understanding on the mechanism of action and potential applications of leronlimab in NASH and oncology.
Job Titles:
- CEO
- Director
- Member of the Audit Committee
- Member of the Compensation Committee
- Audit
Mr. Simes is an accomplished public company CEO who led a number of biopharmaceutical companies during his over 40 year career in the industry. He has extensive experience developing and implementing corporate strategies, establishing growth metrics, driving performance, and meeting growth objectives through organic expansion, acquisitions, and partnerships. When CEO at RestorGenex Corporation, Mr. Simes built a successful senior executive leadership team that delivered significant therapeutic products and stockholder value. He also negotiated the merger of RestorGenex with Diffusion Pharmaceuticals (NASDAQ: DFFN), creating a late-stage oncology-focused biotech company. As CEO at BioSante Pharmaceuticals, Inc., Mr. Simes helped secure significant funding through various financing transactions, acquisitions, and license arrangements. BioSante was later acquired by ANI Pharmaceuticals Inc (NASDAQ: ANIP). At Unimed Pharmaceuticals, Inc., a subsidiary of AbbVie Inc. (NASDAQ: ABBV), Mr. Simes built, developed, and successfully led research and development, finance, sales, and commercial activities, significantly expanding the product portfolio and increasing stockholder value.
Job Titles:
- Chairman
- Member of the Audit Committee
- Member of the Compensation Committee
- Member of the Nominating and Corporate Governance Committee
- Audit
Ms. Urbach is currently Partner/Head of Family Office for Eagle Bay Advisors, which provides family office and investment advisory services, and also provides corporate governance and corporate finance advice to Dynepic, Inc., which provides an integrated platform to power immersive training programs for companies and U.S. military forces. From November 2020 through March 31, 2021, Ms. Urbach was a sole practitioner advising broker-dealers, investment advisers and their professionals. From January 2019 through October 2020, she was a shareholder at the law firm Markun, Zusman, Freniere & Compton in Portland, Oregon. She served as General Counsel for Paulson Investment Company, LLC, a registered broker-dealer that provides investment banking services to the Company from time to time, from July 2015 until January 2019, providing advice regarding corporate governance, securities regulatory compliance, corporate finance, and other legal and securities-related issues. Ms. Urbach earned her bachelor's degree at University of Oregon and her law degree at Lewis & Clark Law School. She served on the Executive Committee of the Oregon State Bar Securities Regulation Section from 2007 through 2015 and 2019 to the present. She brings extensive training and expertise in the conduct of securities offerings, securities litigation, corporate finance and business growth, corporate governance, and other corporate business and legal issues to the Board.
Job Titles:
- Member of the Board of Directors
- Company 's Legal Counsel
- Executive Vice President of Legal Affairs
Mr. Blok has served as the Company's legal counsel since July 25, 2022, and was appointed by the Board as Executive Vice President, Legal Affairs, effective August 15, 2023. Prior to joining the Company, Mr. Blok was an attorney at Buckley Law P.C., from 2021 to 2022, working in the firm's business and transactional practice group, representing corporate clients in the mergers and acquisitions process, and advising business clients in relation to corporate governance matters. From 2013 to 2021, Mr. Blok worked at Markun Zusman Freniere & Compton LLP, later transitioning to TTE Law Group LLP, where he represented various corporate clients in largescale arbitration matters, complex commercial disputes, securities litigation, and a wide variety of regulatory examination and enforcement matters.