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Pipeline

Clene is advancing a pipeline of nanotherapeutics to address high unmet medical need in several disease areas.

CNM-Au8®

CNM-Au8® is a gold nanocrystal suspension currently in development as a disease-modifying treatment for people living with Amyotrophic Lateral Sclerosis (ALS), Multiple Sclerosis (MS), and Parkinson’s Disease (PD).

For additional information on Clene’s trials of CNM-Au8® in ALS:

For additional information on Clene’s trials of CNM-Au8® in MS:

For additional information on Clene’s trial of CNM-Au8® in PD:

CNM-ZnAg

CNM-ZnAg is a proprietary zinc-silver ionic solution that has demonstrated both antiviral and antimicrobial properties.

CNM-AgZn17

CNM-AgZn17 is a topical gel polymer suspension of silver and zinc ions and is being developed for treatment of infectious diseases and to accelerate wound healing.

CNM-PtAu7

CNM-PtAu7 is gold-platinum nanotherapeutic. Initial in vitro research has demonstrated broad-spectrum efficacy across a variety of tumor cell lines.

About Clinical Trials

A clinical trial is a research study used to validate a new treatment or therapy in volunteers. Through clinical trials, researchers and healthcare professionals are able to determine if a treatment is safe and effective, and how it can be used to treat a specific disease or condition.

By participating in a clinical trial, you are taking an active role in the development and approval of new medicines and treatments. People who volunteer in clinical trials provide the medical community with valuable research and data that helps to facilitate the development of new and potentially life-saving therapies.

Mark Mortenson

Chief Science Officer

Mr. Mortenson is the co-inventor of the technology platform developed to produce Clene’s Clean-Surface Nanocrystal (CSN™) therapeutics, as well as the inventor/co-inventor for 30 other U.S. patents and hundreds of corresponding foreign patents.

Prior to joining Clene, Mr. Mortenson served as former Chief Operating Officer of Research, Development and Manufacturing for an advanced materials-based company of more than 300 employees. In addition to his professional experience, he is a former chief patent counsel responsible for approximately 5,500 patents and patent applications in the U.S. and 44 foreign countries. Mr. Mortenson holds both a Bachelor of Science in physics and a Bachelor of Science in ceramic engineering from Alfred University, a Master of Science in material science from Pennsylvania State University, and a Juris Doctor degree from George Washington University.

Rob Etherington

President & CEO

Mr. Etherington brings nearly 30 years of sales, marketing and leadership experience in the pharmaceutical industry to Clene. Prior to joining Clene as CEO, Mr. Etherington worked for Actelion Pharmaceuticals, which was the largest biopharmaceutical company based in the EU until Johnson & Johnson Pharmaceuticals acquired the company in 2017. He initially joined Actelion as founding Director of Marketing in 2000, the same year the company went public, and went on to hold various roles of increasing responsibility. Mr. Etherington served as the first U.S. commercial employee, leading U.S. commercial operations and serving as Chair of the U.S. Commercial Strategic team where he was responsible for five marketed drugs. Prior to Actelion, Mr. Etherington began his pharmaceutical career with a number of sales and marketing roles at Parke-Davis, a division of Pfizer, culminating in a Team Leader position that oversaw the drug Lipitor. As the founding CEO of Clene, Mr. Etherington has raised more than $150M in equity financings, and has driven Clene’s focus on neurodegenerative diseases.

Joanne Zhongyan Zhang M.D., PhD

Director of Micro and Biology

Joanne Zhongyan Zhang is the Director of Micro and Biology at Clene. Dr. Zhang has spent more than 20 years in medical research and is an experienced leader in quality control microbiology laboratory and scientific research in biology. Dr. Zhang helped design, and personally executed the initial and validated Cuprizone Studies of Clene’s asset, CNM Au8, suggesting that Au8 may enhance remyelination in MS. Dr. Zhang designed and directed the ALS pilot study proving that Au8 improved the motor coordination in congenic ALS SOD1 G93A mouse model. Both MS and ALS are now in Clinical Trial Phase II. Dr. Zhang brings to Clene both clinical experience and a successful medical research background. She spent over six years working as an attending physician and chief physician at Tianjin First Central Hospital. Dr. Zhang was a postdoctoral fellow in Cell Biology at Johns Hopkins University; she worked as research associate in the Cardiology Department at Duke University; and prior to Duke was awarded Special Fellow status by the Japan Society for the Promotion of Science while working at Osaka University. Dr. Zhang was awarded her medical degree from Tianjin Medical University and received her PhD from the Cardiology Division of Internal Medicine and Molecular Science at Osaka University.

D. Kyle Pierce

Vice President, Research & Development

D. Kyle Pierce is the Executive Director of Nano-Engineering at Clene. Mr. Pierce has been with Clene since its inception. Mr. Pierce oversees the R&D department, designed the production equipment and software which Clene uses in its manufacturing of their key asset, and developed production procedures. He started his carrier in an antecedent technology and development company, General Resonance, as a Senior Engineer developing the technology used for Clene’s production equipment. While attending the University of Maryland at College Park, where he received a BS in Electrical Engineering, he worked for the Army Material System Analysis Activity (AMSAA DoD). While at AMSAA Mr. Pierce debugged and maintained an active protection performance model software, he was issued a Secret Security Clearance from the Department of Defense. While at Clene, he has co-authored numerous peer reviewed publications.

Austin Rynders

Vice President, Clinical Operations

Austin Rynders is the Vice President of Clinical Operation at Clene. Mr. Rynders is a multi-faceted professional with over 10 years of clinical experience heavily focused in CNS/pain methodology with an emphasis in investigational pain modeling, abuse potential, degenerative disorders, and unique early proof-of-concept study development across Phase I-III studies. With participation and oversight of over 200 clinical trials prior to joining Clene, Mr. Rynders’ exposure to complex and unique study designs has allowed for development of a robust clinical mindset and multiple key accomplishments. These accomplishments include the development and implementation of validated methodologies surrounding ventilatory responses to hypercapnia and quantitative sensory testing, development and beta testing of cognition-based assessment platforms, operational reorganization of multiple clinical operations teams, and the expansion and development of a purpose built 136 bed Phase 1 facility. Mr. Rynders has received a Bachelor of Nursing from the University of Utah and will soon obtain his Master of Science in Pharmacology and Toxicology from Michigan State University.

Adam Dorfman

Vice President, Quality & Technical Operations

Adam Dorfman is the Executive Director of Quality Control and Bioanalytical at Clene. Mr. Dorfman has over 13 years of experience in various roles including nanoparticle development and characterization, specimen bioanalysis, and quality control. Mr. Dorfman has been with Clene since 2013 and is responsible for ensuring that the finished pharmaceuticals meet all quality standards for Clene’s active clinical trials. In addition, he leads the bioanalytical group that analyzes all GLP/GCP tissue and pharmacokinetic specimens that are collected during pre-clinical and clinical activities. Mr. Dorfman was originally tasked with establishing a GMP/GLP compliant lab at Clene, and more recently has been responsible for developing and implementing Clene’s laboratory informatics system that will streamline all manufacturing and quality control processes. He has a BS in Chemical Engineering from The Pennsylvania State University and MS in Chemical and Biomolecular Engineering from Johns Hopkins University.

Mary Anne McNeil

Head of Human Resources

Mary Anne McNeil is the Head of Human Resources at Clene. Ms. McNeil is an accomplished professional with a diverse and successful career in human resources, management and marketing. Prior to joining Clene, Ms. McNeil served as the EVP of Human Resources, Marketing and Sales for a successful art business, where she executed a company culture of diversity, career development, and an outstanding sales force. While there, sales increased by 40%, the employee retention rate doubled and the signing of new artists to represent increased by over 12%. Ms. McNeil is creating a company culture which encourages diversity, growth and learning, open communication and accessibility, recognition for exemplary work, long term careers while striving to make Clene a leading and desirable place of employment. She has started a management training program by working with a local college, has implemented a review and raise process, has encouraged career mapping with all Clene colleagues which has led to many promotions within the company, assisted in developing a comprehensive training program and is working with workforce services to employ individuals from the local area. doubled. She is excited for the future of Clene and looks forward to its success and many upcoming milestones.

Jerry Miraglia, J.D.

General Counsel and Corporate Secretary

Mr. Miraglia has advised small private companies and large public companies, ranging from startups with only an idea to Fortune 125 companies. Most recently, he led the M&A legal team at Jabil Inc (NYSE: JBL), a contract manufacturer with 250,000+ employees operating in 30+ countries, including its medical solutions healthcare division. Mr. Miraglia spent the first 14 years of his legal career in Baltimore, joining Miles & Stockbridge out of law school and becoming a full equity partner in their corporate department, advising such clients as Black & Decker. Mr. Miraglia left Miles to serve as General Counsel for an interactive entertainment company, and subsequently entered the business world and served as EVP for Dover Motorsports (NYSE: DVD) and ultimately President of a media company. Mr. Miraglia’s diverse background navigating both business and legal aspects of corporate transactions, manufacturing, sales, marketing and distribution, providing Clene with a unique blend of insights as it leaves the private sector and enters the public.

Michael Hotchkin

Chief Development Officer

Mr. Hotchkin brings more than 20 years of experience in pharmaceutical commercialization, planning, strategy development, and medical affairs to Clene, where he currently leads commercial planning and strategy development, preclinical translational medicine, and health regulatory authority filings. Prior to joining the company, Mr. Hotchkin was a founding team member at Actelion Pharmaceuticals US, Inc., where he helped launch multiple best-in-class products for orphan disorders. Having spent more than a decade at Actelion, Mr. Hotchkin led the commercialization efforts for the company’s Genetic Business Unit, including clinical development activities which resulted in the doubling of sales for two different pharmaceutical drugs. Among his contributions while at Actelion include the implementation of new market planning activities for the company globally, directing U.S. strategy development and leading marketing activities for multiple medicines. Mr. Hotchkin began his career at Parke-Davis, a subsidiary of Pfizer.

Morgan Brown

Chief Financial Officer

Mr. Morgan Brown has more than 29 years of finance and accounting experience with the last twenty-two years servicing biotechnology, pharmaceutical, medical device and clinical research companies.  Prior to joining Clene as CFO, Mr. Brown served in a similar capacity at Lipocine Inc. (NASDAQ: LPCN), a clinical-stage biopharmaceutical company; at Innovus Pharmaceuticals, Inc. (OTCBB: INNV), an emerging pharmaceuticals company; at World Heart Corporation (NASDAQ: WHRT), a medical device company; at Lifetree Clinical Research, a clinical research organization; and, at NPS Pharmaceuticals Inc. (NASDAQ: NPSP), a biotechnology company.  Previously he worked for KPMG LLP, an international public accounting firm, in Salt Lake City where he served as a Senior Audit Manager. In his roles prior to Clene, Mr. Brown has participated in and led efforts to successfully evaluate, negotiate, and close transactions including equity and debt financings totaling over $1 billion and out-licensing of commercial stage asset transactions totaling $220 million. Mr. Brown has experience in sale-leaseback arrangements, facilities construction, and M&A activities.  Mr. Brown is a licensed certified public accountant in the state of Utah. Mr. Brown earned a Master of Science degree in Business Administration from the University of Utah and a Bachelor of Science degree in Accounting from Utah State University.

Benjamin Greenberg, MD, MHS, FAAN

Head of Medical

Dr. Benjamin Greenberg is an internationally recognized expert in disorders of the central nervous system. He joins Clene alongside his current role as professor of neurology and Vice Chair of Clinical and Translational Research in the Department of Neurology at UT Southwestern Medical Center in Dallas, TX.

His clinical and research expertise spans many areas of neurology including the diagnosis and treatment of MS and other rare neurological disorders. Dr. Greenberg received his Bachelor’s degree from Johns Hopkins University and his Master’s degree in Molecular Microbiology and Immunology from the Johns Hopkins School of Public Health. He graduated from Baylor College of Medicine and completed an internal medicine internship at Rush Presbyterian-St. Luke’s Medical Center in Chicago, before going on to residency in neurology at The Johns Hopkins Hospital in Baltimore.

Rowena Green

Executive Director, Quality Assurance

Rowena Green joined Clene Nanomedicine, Inc. in 2015, with experience in the (bio)pharmaceutical, nutraceutical, medical device and environmental industries. With over twenty-three years of GxP experience, eighteen years are as a quality assurance representative, which confirms her role as Sr. Director of Quality Assurance. Prior to Clene, Rowena spent three years as a consultant at Meridian BioGroup. There, she supported multiple clients to ensure compliance to the appropriate regulations (i.e., GMPs, GLPs). Prior to being a consultant, Rowena worked with Johns Hopkins University as the Quality Manager of the Cell Processing and Gene Therapy Department, which manufactured clinical trial material for multiple JHU Investigators. With a Bachelor of Science Degree in Chemistry, Rowena has worked as a Manufacturing Operator to produce brain cancer treatment, developed clinical trial projects to manufacture API as a Research Associate in Chemical Development, and performed the data review for one of the largest MRSA clinical studies ever conducted as a Sr. Quality Assurance representative. Rowena’s experience in the various industries has led her to Clene, where she and her direct reports provide regulatory support and quality assurance oversight for at least seven on-going clinical studies.