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Location: Seattle, Washington
Sector: Life Sciences
Nativis has invented a groundbreaking therapeutic device technology that uses ultra-low radio frequency energy (ulRFE®) to interrupt disease mechanisms on the molecular and genetic levels – without chemicals or radiation. Nativis ulRFE is able to replicate the biological activity of a broad range of molecules including proven drugs, siRNA, mRNA, and endogenous compounds like hormones. The resulting therapeutic product profile provides localized delivery of a proven mechanism of action, avoiding systemic toxicity, and allowing for cost-effective combination therapy (multiple targets on one device). The therapeutic benefit is delivered via a simple-to-use investigational device called Nativis Voyager®, pictured below. The controller weighs 6 ounces and the coil can be shaped to deliver the ulRFE® field to the desired areas of the body, avoiding exposure of other organs to maximize safety.
First breakthrough therapy in brain cancer – Most drugs don’t penetrate the blood brain barrier, consequently brain cancer drugs have not improved GBM outcomes in over 20 years. Nativis uniquely treats brain cancer in a way that minimizes safety and has potential to improve survival to unprecedented extent.
Fast to market HDE pathway – From identifying an HDE opportunity to regulatory submission takes roughly six months for Nativis, leveraging our ability to mimic existing mechanisms and rapidly enter preclinical and clinical testing. From FDA submission to approval is roughly 6 months so the entire process takes about a year, dramatically less than a drug pathway.
Unique approach to cancer immunotherapy – The immuno-oncology (I/O) market is exploding, from $6 billion sales in 2017 to more than $20 billion forecasted within 5 years. I/O drugs are not able to pass the blood-brain barrier and have significant toxicity issues. Voyager provides localized therapy minimising toxicity, while leveraging the industry’s identification of key I/O targets (e.g. PD1, PDL1, CTLA4) for rapid progress into clinical trials. Voyager has already been used to treat 9 patients using anti-PD1 and anti-CTLA4 mechanisms, moving much faster and less expensively than a comparable drug program.
Ability to leapfrog current cancer therapeutics – Cancer experts are agreed that combination therapy is critical. Voyager uniquely can deliver combination therapy (multiple mechanisms played sequentially on a single device) in a way that is cost-effective and minimizes systemic side effects.
Beyond cancer, rapid entry to pain, inflammation, and other therapeutic areas – Nativis has identified opportunities in pain, inflammation, and infectious diseases where there are large markets with unmet needs that match up with the Voyager platform advantages. For example the global anti-TNF drug market (treating arthritis and other inflammatory diseases) is over $40 billion and would be bigger if it were not held back by patient concerns about chronic immuno-suppression side effects. Voyager has potential to deliver anti-TNF mechanism without immunosuppression, as well as providing localized pain relief.
Multiple vertical opportunities beyond human health – Nativis Voyager has been tested in over 300 dogs with naturally occurring cancers, showing promising signs of efficacy in over 20 tumor types. Discussions are underway with veterinary health companies who are interested in licensing Voyager for companion animal cancer. A joint research program is underway with an AgBio company that is testing how Nativis technology can revolutionize plant and livestock agribusiness. Nativis has demonstrated the ability to increase lipid production in algae culture, resulting in interest from industrial biotech companies. In all these areas beyond human health, Nativis will not invest its own money in R&D – instead the partners who identify opportunities will pay for the R&D and commercialization, with business impact accretive to Nativis.
Our initial focus is on the treatment of patients with brain cancer who are not well served by conventional standard of care therapies, which often result in poor outcomes and devastating side effects. Initial results from the human clinical trial (n=64) of Nativis Voyager® device in recurrent glioblastoma multiforme (rGBM) brain tumors has shown no device-related adverse events and promising signs of efficacy. The company completed its first licensing agreement for this indication in April 2017 with Teijin Pharma, a large Japanese pharma company, and discussions continue regarding additional ulRFE® licenses to treat other conditions in Japan. Other licensing discussions are underway with multiple global pharmaceutical companies. In addition to GBM, Nativis is pursuing three rare pediatric brain cancers in the US (medulloblastoma, diffuse midline glioma, and ependymoma) through an accelerated FDA pathway called Humanitarian Device Exemption (HDE). We expect to have FDA approval for these three indications by end of year 2018 and to have our first commercial revenue in early 2019, with the potential to reach $100 million in revenue in these three indications alone by 2022. Nativis is targeting one to two HDE approvals per year for the foreseeable future, with HDE revenues totaling $200 million by 2023.
Chris E. Rivera – President, Chief Executive Officer and Chairman of the Board
Chris brings more than 30 years of experience in the biotechnology industry. Chris was the Founder and CEO of Hyperion Therapeutics, which was acquired by Horizon Pharma in 2015, the Senior Vice President and head of Commercial Operations at both Tercica, where he led the cross-licensing transaction between Tercica and Ipsen, and Genzyme Therapeutics, where he built and ran Genzyme’s US renal Commercial Operations, he also helped launch Genzyme’s renal division globally. Prior to Genzyme, he helped build Cephalon and Centocor’s initial commercial infrastructures.
Kenneth Ferguson, PhD – Chief Scientific Officer
Ken is Chief Scientific Officer at Nativis. Prior to joining Nativis, Ken was vice president and chief development officer at Omeros Corporation, CEO of VacTX, and spent 16 years at ICOS Corporation in research and development, where he was Product Development Team Leader and later the Chief Scientific Officer and Board member of the Lilly ICOS Joint Venture. Ken is a graduate of Cornell University and The University of Texas Health Science Center at Dallas. His doctoral research with Dr. Al Gilman focused on signal transduction, specifically the mechanism by which G proteins participate in the action of G protein-coupled receptors. Ken completed post-doctoral studies with Dr. Michael Wigler at Cold Spring Harbor Laboratory with a focus on oncogenes and the cell cycle.
Xavier A. Figueroa, PhD – Director, Pre-clinical Development
Xavier is the principal scientist for Nativis overseeing pre-clinical research and the application of Nativis technology in multiple disease areas. He has more than 20 years of experience in basic and neurological clinical research, including Alzheimer’s research, neuron biology, cancer research, bioengineering and biophysics. He has advised emerging biotechnology companies, most notably Cytokinetics and ENG3. Xavier has also served on non-profit Scientific Advisory boards for such organizations as the Brain Health and Healing Foundation and published broadly in multiple areas of science and medicine. Xavier received his doctoral degree in Neurobiology & Behavior from the University of Washington. His doctoral training was followed by two post-doctoral fellowships within the University of Washington’s Department of Bioengineering. He is currently an affiliate assistant professor in the School of Medicine at the University of Washington.
David Matteson, MPH, MEd, MPA – Investor Relations and Education
David is a seasoned business leader and strategist, who has dedicated his career to advancing health innovations, services, and products into the market place. Prior to joining Nativis full time in 2012, he consulted to early- and growth-stage companies in healthcare to develop strategic plans, raise capital, craft public policy campaigns, design and implement marketing and branding programs, manage company growth and change, and foster high-performance teams at both the board and C-suite levels. As an executive coach he has worked with dozens of entrepreneurs to hone their ideas into viable business structures and lead their ventures through the volatile journey to market. David has a diverse background that spans five academic preparations and numerous executive positions across several industries. This broad base of training and experience provides a unique, integrated, and long-view perspective that is valuable when designing integrated business structures and strategies to move innovation into the market. He has a proven track record of brokering and managing multi-disciplinary teams to tackle complex business opportunities.
Michael Mischke-Reeds, MA – SVP of Business Development
Michael has over 25 years of leadership experience in life sciences companies, having worked as a startup biotech executive and a management consultant, specializing in biotechnology. After studying biology and management science at Stanford University, he co-founded startup companies Fast Track Systems (software to support pharmaceutical clinical development) and Chiron Informatics (disease management software for HIV). His management consulting career started at Strategic Decisions Group (world leader in pharmaceutical asset valuation and portfolio management) and then cofounded Keelin Reeds Partners (biotech-focused consulting firm offering valuation, strategy, and transaction support). Michael is currently Senior Vice President of Business Development for Nativis, where he leads partnering activities as well as strategy and valuation.
Donna Morgan Murray, PhD – Chief Regulatory Officer
Donna is the Chief Regulatory Officer for Nativis. A seasoned healthcare professional, she has more than 30 years of experience in the biotechnology and pharmaceutical industries. She’s authored more than 60 publications and served on several non-profit boards and organizations. Donna holds a PhD from the University of Texas Health Science Center at Houston.
Eric Peterson – Director of Development and Manufacturing
Eric brings more than 20 years of experience in developing, manufacturing and commercializing innovative medical devices in fast growing start-up companies. He serves as the Director of Development and Manufacturing at Nativis, where he is responsible for leading design, development and manufacturing operations with strategic partners while ensuring compliance with FDA and ISO standards.
Steven Pope, MA (Oxon) JD – Corporate Secretary and Sr. VP, General Counsel
Steven is responsible for overseeing the legal affairs of the Company, including contracts, securities, governance, intellectual property, and employment matters. Prior to joining Nativis in 2010, Steven was a Partner at Perkins Coie LLP. Steven received his J.D. cum laude from Seattle University School of Law where he was a member of the Law Review, his M.A. from the University of Oxford, and his B.A. summa cum laude from Gonzaga University.
Gabriel Vogeli, PhD – Senior Distinguished Scientist
Gabriel, Distinguished Scientist, is the former Director of Molecular Biology for Dendreon Corporation, former Senior Scientist at Upjohn Company/Pharmacia-Upjohn and Senior Staff Fellow at the National Institutes of Health. Gabriel holds a PhD from the University of Zurich, and was a Postdoctoral Fellow at Yale University.