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Alzamend Neuro Announces Full Data Set From Phase 1 First-in-Human Clinical Trial for AL001 Treatment of Dementia Related to Alzheimer’s

ATLANTA–(BUSINESS WIRE)– Alzamend Neuro, Inc. (Nasdaq: ALZN) (“Alzamend”), an early clinical-stage biopharmaceutical company focused on developing novel products for the treatment of neurodegenerative diseases and psychiatric disorders, today announced that it has received the full data set from its Phase 1 clinical trial for AL001. The purpose of the Phase 1 first-in-human trial was to determine the pharmacokinetics, safety and tolerability of AL001. These data will help Alzamend establish doses for a planned Phase 2 multiple ascending dose study in Alzheimer’s disease (“Alzheimer’s”) patients. AL001 is a novel lithium-delivery system; it is a lithium-salicylate-L-proline engineered ionic cocrystal under development as an oral treatment for patients with dementia related to mild, moderate, and severe cognitive impairment associated with Alzheimer’s. AL001 has the potential to deliver benefits of marketed lithium carbonate without current toxicities.

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Alzamend / 20+ years Experience, Research and Technology Transfer and Partnerships

Terri Hunter, Ph.D.

Terri Hunter, Ph.D. is a Technology Transfer Specialist at the United States Department of Veterans Affairs (USDVA). Dr. Hunter joined the USDVA in September 2020 and is responsible for managing life science technologies from initial disclosure through licensing and the maintenance of the license. Prior to joining the USDVA, Dr. Hunter worked as a senior licensing manager in the technology transfer Office, patents & licensing at the University of South Florida for 9 years (2010 to 2020). From 2003 to 2010, Dr. Hunter worked as a Research Scientist at Moffitt Cancer Center in Tampa, Florida. At Moffitt Dr. Hunter performed translational research focused on cancer vaccines and combination therapies for cancer. She has also served as a DNA analyst/expert witness for the Florida Department of Law Enforcement. Her post-doctoral training was conducted at St. Jude Children’s Research Hospital in Memphis, Tennessee form 1998-2000. She received a B.S. in Biology from Palm Beach Atlantic University in 1994, a M.S. in Medical Sciences from the University of South Florida, College of Medicine in 1997, and a Ph.D. in Medical Sciences from the University of South Florida, College of Medicine (1998, Medical Microbiology and Immunology Program). Dr. Hunter’s research interests included microbial genetics, DNA analysis, cell signaling, immunobiology of cancer, gene-modified tumor cell vaccine research: specifically pre-clinical and clinical research and combination biologic and pharmacologic treatments for cancer.

Alzamend / Director of NYU Langone’s Pearl I. Barlow Center for Memory Evaluation and Treatment

Thomas M. Wisniewski, MD

Dr. Wisniewski is a board-certified neurologist and neuropathologist and is the Director of the NYU Pearl Barlow Center for Memory Evaluation and Treatment who operates an active research laboratory focusing on neurodegenerative disorders with a particular focus on the mechanisms that drive amyloid deposition in Alzheimer’s and prion diseases. This work has led to over 300 peer-reviewed publications, 25 issued patents, and continuous funding from the NIH for over 26 years.

Dr. Wisniewski’s career has been dedicated to researching and developing treatments for numerous conditions including Alzheimer’s disease, mild cognitive impairment, Lewy body dementia, frontotemporal dementia, prion disease, Jakob-Creutzfeldt disease, multiple system atrophy and memory loss. This has led him to receive numerous awards, honors and recognitions including being elected as a Distinguished Fellow in 2014, receiving the 2009 Prion Prize, the Alzheimer’s Association Zenith Award in 2002 and being recognized every year by “Best Doctors in America” since 2008. Dr. Wisniewski has been an Associate Editor for the Journal of Alzheimer’s Disease and Chief Editor of Frontiers in Aging Neuroscience since 2018.

Dr. Wisniewski earned his MD at King’s College London GKT School of Medical Education and completed his residencies and chief residencies in neurology and neuropathology at NYU School of Medicine and New York-Presbyterian/Columbia University Medical Center, respectively.

Alzamend / Co-Director of the DIAN Trials Unit and Clinical Trials Leadership at Washington University School of Medicine

Eric M. McDade, DO

Dr. Eric McDade is a board-certified cognitive neurologist that has focused his activities on the evaluation of those with dementia syndromes and on developing a clinical research program that focuses on using brain imaging and cerebrospinal fluid markers to identify those at risk for Alzheimer disease. Currently, Dr. McDade is leveraging his clinical expertise to develop a cross-disciplinary team that combines neuroimaging, clinical evaluations and basic science to better explore and translate work in the use of imaging and fluid biomarkers to better understand the timing and relationship between measures of disease risk and progression. The goal of this work is to identify better measures and target for interventions and prevention for Alzheimer’s disease and has led to over 76 peer-reviewed publications and continuous funding from the NIH for over 10 years.

Additionally, Dr. McDade is the Co-Director of the Dominantly Inherited Alzheimer Trials Unit (DIAN-TU). The DIAN-TU is a global network of families at risk for a genetic form of AD and is pioneering prevention trials for this young-onset for of AD. As part of this he serves as the Principle Investigator of the DIAN-TU Primary Prevention Study. He is also the Director of the DIAN Expanded Registry (DIAN EXR). The DIAN EXR is an international research registry for individuals with confirmed or suspected dominantly inherited Alzheimer’s disease (DIAD) in their families and for professionals and researchers involved in clinical care and research on DIAD. These projects will prove critical to advancing the field of Alzheimer disease treatment.

Dr. McDade has received several awards and honors in recognition of his work and leadership including the NIH-NIA K23 Training Grant Award and a NIH-NIA UO1 award for the DIAN-TU Primary Prevention Trial. Additionally, he has been a LRP Recipient and received the Excellence in Clinical Teaching Award and has been on the Best Doctors in St. Louis and in Pittsburgh lists.

Dr. McDade earned his doctorate at Chicago College of Osteopathic Medicine and a B.A. in Psychology from Canisius College. Dr. McDade completed an internship at the University of Illinois College of Medicine in Chicago and his residency at the University of Maryland. Dr. McDade has his certification of Neurology from the American Board of Psychiatry and Neurology and Behavioral Neurology from the United Council of Neurologic Subspecialties.

Alzamend / Practicing physician at Santa Monica Neurological Consultants, Assistant Clinical Professor of Neurology at the David Geffen School of Medicine at UCLA and Cedars-Sinai Medical Center

Andrew H. Woo M.D., Ph.D.

Andrew H. Woo, M.D., Ph.D. joined our Board of Directors in June 2021. Dr. Woo is in private practice at Santa Monica Neurological Consultants and serves as an Assistant Clinical Professor of Neurology at the David Geffen School of Medicine at UCLA and Cedars-Sinai Medical Center. He also serves on the board for the Multiple Sclerosis Association of America and its Navigating MS International Steering Committee. He has been presented with UCLA clinical faculty teaching awards in 2006, 2012 and 2019 and is listed in America’s Top Physicians by the Consumer Research Council of America and Castle Connolly America’s Top Doctors 2006, 2007, 2010-2022, Southern California Super Doctors since 2008, and Los Angeles Magazine Top Doctors. He is an invited speaker to the Muntada International Symposium in Abu Dhabi. Dr. Woo received his B.A. from Cornell University and completed his M.D. and Ph.D. in Neuroimmunology in the Department of Molecular and Cell Biology at Brown University. He completed his medicine internship at Weil-Cornell Presbyterian Hospital/Cornell Medical Center in New York, his neurology residency at UCLA, and his fellowship in neurophysiology at Harbor-UCLA. We believe that Dr. Woo’s extensive medical experience gives him the qualifications and skills, and relevant insight, to serve as one of our directors.

Alzamend / Regulatory Affairs and Product Development Consultant

Lynne Fahey McGrath, M.P.H., Ph.D.

Lynne Fahey McGrath, M.P.H., Ph.D. joined our Board of Directors in June 2021. Dr. McGrath is currently a consultant to the executive team of Nobias Therapeutics, Inc., a biotechnology product development company, since May 2020, and served as a regulatory consultant with FoxKiser, LLC, a biotechnology consulting firm, from August 2018 to March 2020. Dr. McGrath was the Vice President of Regulatory Affairs of Regenxbio, Inc., where she headed global strategy for its portfolio of gene therapy products, from April 2015 to 2019. Previously, she held senior positions at Novartis Corporation including Vice President, Global Head of Regulatory Affairs at Novartis Consumer Health and U.S. Head of Regulatory Affairs at Novartis Oncology from 2003 to April 2015. Dr. McGrath received a B.S. degree from the University of Connecticut, M.S. in environmental science from Rutgers University and M.P.H. and Ph.D. in public health from the University of Medicine and Dentistry of New Jersey Robert Wood Johnson Medical School. We believe that Dr. McGrath’s expertise in regulatory affairs and pharmaceutical product development across a range of therapeutic categories and her more than 30 years of experience directing worldwide approvals of more than 50 new drugs and indications makes her well qualified to serve as one of our directors.

Alzamend / Chief Financial Officer of PharmaKure Limited

Mark Gustafson C.P.A.

Mark Gustafson joined our Board of Directors in June 2021 and is Chairman of the Audit Committee. Mr. Gustafson is a Chartered Professional Accountant with over 35 years of corporate, private and public company experience. Since April 2021, Mr. Gustafson has been the Chief Financial Officer for PharmaKure Limited, a London-based biopharmaceutical company dedicated to the treatment of neurodegenerative diseases. From 2014 to 2020, he was the Chief Executive Officer of Challenger Acquisitions Limited, a London Stock Exchange listed entertainment company. From 2010 to 2012, Mr. Gustafson was the President and Chief Executive Officer of Euromax Resources Limited, a Toronto Stock Exchange listed mineral exploration company. From 2005 to 2009, he served as Chairman and Chief Executive Officer of Triangle Energy Corporation, a New York Stock Exchange listed oil and gas exploration company, from 2004 to 2006, he served as President and Chief Executive Officer of Torrent Energy Corporation, a private oil and gas company, and from 2001 to 2002, he served as a financial consultant for Samson Oil & Gas and Peavine Resources, two private oil and gas companies. From 1997 to 1999, Mr. Gustafson served as President and Chief Executive Officer of Total Energy Services Ltd., a Toronto Stock Exchange listed oilfield services company, from 1993 to 1995, he served as the Chief Financial Officer of Q/media Software Corporation, a Toronto Stock Exchange listed software company, and from 1987 to 1993, he served initially as the Chief Financial Officer and then as a Vice President in charge of two operating divisions at EnServ Corporation, a Toronto Stock Exchange listed oilfield services company. From 1981 to 1987, he served as an audit manager at Price Waterhouse in Calgary Alberta. Mr. Gustafson received his Bachelor of Business Administration from Wilfrid Laurier University. We believe that Mr. Gustafson’s over 35 years of corporate, private and public company operational and financial experience gives him the qualifications and skills to serve as one of our directors and as Chairman of the Audit Committee.

Alzamend / Principal at Godby Realtors​

Jeffrey Oram

Jeffrey Oram joined our Board of Directors in June 2021. Mr. Oram is a business professional with more than 25 years of corporate, private and institutional investment experience. Mr. Oram has spent the last 13 years in the institutional real estate capital markets. Since 2016, he has been a Principal at Godby Realtors, a private real estate investment and brokerage firm. From 2010 to 2018, Mr. Oram served as an Executive Member of the New Jersey State Investment Council, which oversees the investment of the State of New Jersey’s $80 billion pension fund. From 2011 to 2016, he served as Executive Managing Director at Colliers International, from 2009 to 2011 he served as Director at Marcus and Millichap, and from 2003 to 2009, served as First Vice President at CB Richard Ellis. Mr. Oram received a Bachelor of Science degree in biology from Princeton University. We believe that Mr. Oram’s 25 years of corporate, private and institutional investment experience gives him the qualifications and skills to serve as one of our directors.

Alzamend / CHAIRMAN OF ALZAMEND, CHIEF EXECUTIVE OFFICER OF AULT ALLIANCE, INC.

William B. Horne

William B. Horne has served as a director of our company since June 2016. Mr. Horne served as the Chief Financial Officer from June 2016 through December 2018. Mr. Horne currently serves as Vice Chairman and Chief Executive Officer at Ault Alliance, Inc. (previously “BitNile Holdings, Inc.” FKA “Ault Global Holdings”) since January 12, 2021. Mr. Horne has been a member of the board of directors of Ault Alliance, Inc. since October 2016. In January 2018, Mr. Horne was appointed as Ault Alliance, Inc.’s Chief Financial Officer until August 2020, when he resigned as its Chief Financial Officer and was appointed as its President.

Mr. Horne previously held the position of Chief Financial Officer in various companies in the healthcare and high-tech field, including OptimisCorp, from January 2008 to May 2013, a privately held, diversified healthcare technology company. Mr. Horne served as the Chief Financial Officer of Patient Safety Technologies, Inc., a medical device company, from June 2005 to October 2008, and as the interim Chief Executive Officer from January 2007 to April 2008. In his dual role at Patient Safety Technologies, Mr. Horne was directly responsible for structuring the divestiture of non-core assets, capital financings and debt restructuring. Mr. Horne has also held supervisory positions at Price Waterhouse, LLP. Mr. Horne holds a B.A. degree in accounting from Seattle University.​ We believe that Mr. Horne’s extensive financial and accounting experience in diversified industries and with companies involving complex transactions gives him the qualifications and skills to serve as one of our directors. 

Alzamend / Founder and Vice Chairman of Alzamend

Milton C Ault, III

Milton “Todd” Ault III serves as Executive Chairman at Ault Alliance (previously “BitNile Holdings”). Mr. Ault is a seasoned business professional and entrepreneur that has spent more than twenty-seven years identifying value in various financial markets, including equities, fixed income, commodities, and real estate. Mr. Ault’s most recent efforts have been as a consultant to a few publicly traded and privately held companies, where he has provided each of them the benefit of his diversified experience, ranging from development stage to seasoned businesses. In 2011, Mr. Ault founded Avalanche International Corp., a Nevada corporation, the parent company of MTIX, Ltd., the developer of Material Laser Surface Enhancement (“MLSE”), the material synthesis technology for textile applications.

In February 2016, Mr. Ault founded Alzamend Neuro, Inc., a biopharmaceutical company focused on developing novel products for the treatment of Alzheimer’s disease, Bipolar disorder, Major Depressive Disorder (“MDD”) and Post-Traumatic Stress Disorder (“PTSD”). Mr. Ault was elected to the board of directors of Patient Safety Technologies, Inc. (OTCBB:PSTX, OTCQB:PSTX) (“PST”) in July 2004, and became its Chairman and Chief Executive Officer in October 2004 serving until January 2006, and again from July 2006 to January 2007. Stryker Corporation (NYSE:SYK) acquired PST at the beginning of 2014 in a deal valued at approximately one hundred twenty million dollars ($120,000,000). PST’s wholly-owned operating subsidiary, SurgiCount Medical, Inc., is the company that developed the Safety-Sponge® System; a bar coding technology for inventory control that aims to detect and prevent the incidence of foreign objects left in the body after surgery. Mr. Ault was a registered representative at Strome Securities, LP, from July 1998 until December 2005, where he was involved in portfolio management and worked on several activism campaigns including Taco Cabana, Jack In The Box (formerly Foodmaker), and 21st Century Holdings Co.

Alzamend / Chief Operating Officer

David J. Katzoff

David Katzoff joined our company on a part-time basis in November 2019, serving as our Senior Vice President of Operations from November 2019 to December 2020, and currently serves as Chief Financial Officer since August 2022. Mr. Katzoff has served as Senior Vice President of Finance of Ault Alliance, Inc. (previously “BitNile Holdings, Inc.” FKA “Ault Global Holdings”) since January 2019. From 2015 to 2018, Mr. Katzoff served as Chief Financial Officer of Lumina Media, LLC, a privately-held media company and publisher of life-style publications. From 2003 to 2017, Mr. Katzoff served as Vice President of Finance of Local Corporation, a publicly-held local search company. Mr. Katzoff received a B.S. degree in Business Management from the University of California at Davis.

Alzamend / ALZAMEND / EXECUTIVE VICE PRESIDENT, GENERAL COUNSEL AND DIRECTOR

Henry C.W. Nisser

Henry C.W. Nisser has served as our Executive Vice President and General Counsel on a part-time basis since May 2019. Mr. Nisser was appointed as a director in September 2020. Since May 2019, Mr. Nisser has served as the Executive Vice President and General Counsel of Ault Alliance, Inc. (previously “BitNile Holdings, Inc.” FKA “Ault Global Holdings”) and as one of its directors since September 2020; he became Ault Alliance, Inc.’s President on January 12, 2021. Mr. Nisser is the Executive Vice President and General Counsel of Avalanche. From October 2011 through April 2019, Mr. Nisser was an associate and subsequently a partner with Sichenzia Ross Ference LLP, a law firm in New York. While with this law firm, his practice was concentrated on national and international corporate law, with a particular focus on U.S. securities compliance, public as well as private M&A, equity and debt financings and corporate governance. Mr. Nisser drafted and negotiated a variety of agreements related to reorganizations, share and asset purchases, indentures, public and private offerings, tender offers and going private transactions. Mr. Nisser is fluent in French and Swedish, as well as conversant in Italian. Mr. Nisser received his B.A. degree from Connecticut College, where he majored in International Relations and Economics. He received his LL.B. from University of Buckingham School of Law in the United Kingdom. We believe that Mr. Nisser’s extensive legal experience involving complex transactions and comprehensive knowledge of securities laws and corporate governance requirements applicable to listed companies give him the qualifications and skills to serve as one of our directors.

Alzamend / Senior Vice President of Finance

Kenneth S. Cragun

Kenneth S. Cragun joined our company on a part-time basis in December 2018. He served as a CFO Partner at Hardesty, LLC, a national executive services firm since October 2016. His assignments at Hardesty included serving as Chief Financial Officer of CorVel Corporation, a publicly traded company and a nationwide leader in technology driven, healthcare-related, risk management programs, and of RISA Tech, Inc., a private structural design and optimization software company. Mr. Cragun was also Chief Financial Officer of two Nasdaq-traded companies, Local Corporation, from April 2009 to September 2016, which operated Local.com, a U.S. top 100 website, and Modtech Holdings, Inc., from June 2006 to March 2009, a supplier of modular buildings. Prior thereto, he had financial leadership roles with increasing responsibilities at MIVA, Inc., ImproveNet, Inc., NetCharge Inc., C-Cube Microsystems, Inc, and 3-Com Corporation. Mr. Cragun is currently the Chief Financial Officer of Ault Alliance, Inc. (previously “BitNile Holdings, Inc.” FKA “Ault Global Holdings”) and serves on the board of directors and Chairman of the Audit Committee of Verb Technology Company, Inc. Mr. Cragun began his professional career at Deloitte. Mr. Cragun holds a Bachelor of Science degree in accounting from Colorado State University-Pueblo.

Alzamend / Chief Executive Officer and Director

Stephan Jackman

Stephan Jackman joined our company as Chief Executive Officer in November 2018. Mr. Jackman was elected as a director in September 2020. He has played an intricate role in the development of therapeutic treatments, products and programs from the research stage to market and commercialization. Mr. Jackman has demonstrated a dedicated dual focus of creating value for internal and external stakeholders while developing strategic alliances and cross-function teams to meet and exceed goals. Mr. Jackman has experience managing profit and loss budgets totaling $100 million and successfully implemented projects/programs totaling $500 million. Prior to joining our company, from October 2017 to November 2018, Mr. Jackman was the Chief Operating Officer of Exit 9 Technologies, a technology startup with an Internet platform delivering opted-in lifestyle audiences to media, publishers, retailers and brands. Mr. Jackman was Chief Operating Officer of Ennaid Therapeutics from October 2015 to October 2017, an emerging biopharmaceutical company focusing on cures for mosquito borne infectious diseases such as Zika and Dengue viruses. Additionally, from August 2014 to October 2015, he was an independent project and management consultant assisting startups, Fortune 500 companies and non-profits with major strategic initiatives. He has also held positions of increasing responsibility at Novartis Pharmaceuticals Corporation, L’Oréal USA, SBM Management Services and Family Intervention Services. Mr. Jackman holds a Master of Science in Management and a Bachelor of Engineering in Mechanical Engineering from Stevens Institute of Technology.
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