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Spinogenix is developing a new class of therapeutics to help restore the brain connections and functions lost in brain injury and neurodegenerative diseases.

A unifying feature of neurodegenerative conditions is the loss of connections (synapses) between brain cells (neurons). Neuron-to-neuron communication via synapses allows us to think, feel, move and remember. Neurodegenerative diseases including Alzheimer’s (AD) and Parkinson’s (PD) result in a progressive loss of synapses, and it is this feature of brain pathology that most closely underlies their devastating symptoms. But synapse loss is not limited to disease. It also results from Traumatic Brain Injury (TBI) – a risk factor for both AD and PD – where synapse loss involves similar underlying mechanisms.

Spinogenix was founded to develop first-in-class drugs (SPGs) to reverse synapse loss, restoring connections lost to neurodegenerative diseases, TBI, and other conditions involving the central nervous system (CNS). The largest unmet need that our drugs address is AD, which currently affects an estimated 5.7 million Americans, 96% of whom are 65 years of age or older. Currently, there are no FDA approved therapies that alter the course of AD; at best, the drugs available afford only temporary and modest symptom relief that typically lasts for less than 2 years.

SPGs comprise an entirely novel strategy to treating AD, one focused on the regeneration of synapses. This is very different from most drugs currently under development for AD, which focus on inhibiting the accumulation of proteins (amyloid beta and phospho-tau) that build up in the course of the disease. At Spinogenix, we are focused on the root of the problem, the loss of synapses. SPGs have shown the ability to regenerate synapses and this is achieved through their direct modulation of synaptic proteins that have not yet been the subject of CNS drug development.

At its core, our approach to restoring synapses has the potential to address a root problem of most neurodegenerative conditions – synapse loss – tipping the balance from degeneration to regeneration. The drugs we are developing for AD can also address the enormous and varied unmet needs posed by TBI, PD, and other neurodegenerative conditions. Beyond these conditions, SPGs may be of therapeutic benefit in other CNS disorders, such as depression and schizophrenia, that involve synapse loss in specific brain regions. We look forward to working with medical professionals, patients and partners to improve brain function and quality of life in people with AD and other indications.

Franz Hefti, Ph.D. - Chairman of the Board

Dr. Hefti is the former COO of Proclara, having previously served as president and interim chief executive officer and chair of the company’s scientific advisory board. He has 20 years of experience in the pharmaceutical and biotechnology industry and more than a decade of experience in academia. Prior to joining Proclara, Dr. Hefti was the chief scientific officer at Avid Radiopharmaceuticals, a company developing a diagnostic agent for Alzheimer’s disease and that was acquired by Eli Lilly in 2010.

Before that, he led the drug development efforts as the executive vice president of drug development at Rinat Neuroscience Corporation. During his tenure at Rinat, three antibody drug candidates advanced from the discovery stage through preclinical and clinical development, and the success of these programs led to the acquisition of Rinat Neuroscience by Pfizer in 2006. Previously, Franz was the senior vice president of neuroscience research at Merck and Co., and the director of the neuroscience research department at Genentech. Earlier in his career, he spent more than a decade in academia as a professor at the University of Southern California and an associate professor at the University of Miami, where he carried out seminal research on therapeutic applications of neurotrophic factors. Dr. Hefti received a doctorate with honors from the University of Zurich and completed his postdoctoral research at the Massachusetts Institute of Technology and the Max Planck Institute in Munich.

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Stella Sarraf, Ph.D. - Acting Chief Executive Officer, Founder

Dr. Sarraf founded Spinogenix, Inc. in 2016. She brings a blend of large pharmaceutical operational expertise, venture investment background and entrepreneurship to Spinogenix. Dr. Sarraf is viewed as a visionary with a deep understanding of “cradle to grave” and the necessary components to achieve success from product concept through to commercialization. In 2013, she founded Amydis, a privately-held company focused on developing innovative chemistry to identify patients at risk for amyloid associated diseases, such as Alzheimer’s and Parkinson’s Disease.

Previously, Dr. Sarraf spent over 10 years in Venture Capital at Foresite Capital Management and Prospect Venture Partners, both growth capital healthcare funds with over $1B dollars in assets under management. Some successful investments and exits by Foresite with Dr. Sarraf’s involvement included Wavetec Vision (sold to Alcon in 2014), Ambit Biosciences (acquired by Daiichi Sankyo in 2014 for $410M) and Auspex Pharmaceuticals (sold to Teva for $3.5B in 2015). At Prospect, she performed scientific, regulatory and commercial diligence on more than 400 investment opportunities from companies in therapeutic and diagnostic areas including the neurological and cognitive disorder space. Earlier in her career, Dr. Sarraf worked at Merck Research Laboratories in Rahway, New Jersey as a senior research chemist responsible for creating the chemical synthesis of a novel drug for translation from the bench to production scale. Dr. Sarraf holds a PhD in organic chemistry from Columbia University and earned a BA in biochemistry and molecular biology from the University of California, Berkeley.

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Vincent F. Simmon, Ph.D. - Chief Operating Officer

Dr. Simmon joined Spinogenix soon after it was founded in early 2016. Vince is an accomplished senior executive with broad experience in the biotech industry since 1979. Dr. Simmon was previously CEO of publicly traded companies, Alpha 1 Biomedicals and Cortex Pharmaceuticals. In addition, he was the CEO of privately-held companies, Xytis Inc. and COO of Merrimack Pharmaceuticals.

As a senior member of management or CEO, he has successfully led research and clinical development in small biotech companies as well as WR Grace&Co. His experience includes leading multinational clinical trials in mild cognitive impairment and traumatic brain injury, Phase 1 and 2 clinical trials in Alzheimer’s disease, schizophrenia, rheumatoid arthritis and psoriasis as well as clinical trials in AIDS, hepatitis B and hepatitis C. He has negotiated R&D and licensing deals with Organon (ultimately acquired by Merck), Servier, Green Cross and Yoshitomi in Japan, Shire and Pharmacia (acquired by Pfizer).

Vince earned his Ph.D from Brown University in Molecular and Microbiology and received his BA from Amherst College. He was a post-doctoral fellow at Stanford University and received Executive MBA training at Stanford and WR Grace.

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Elizabeth Vadas, Ph.D, FAAPS - Head of R&D

Dr. Vadas joined Spinogenix as Head of R&D in 2017. She started her pharmaceutical career at Merck Frosst, the Canadian subsidiary of Merck & Co. in 1980, where she spent 22 years in the department of Pharmaceutical R&D. She served as Executive Director of Pharmaceutical Research and Development at Merck Frosst from 1991 to 2002 and was involved in the early characterization and formulation development of many new chemical entities discovered at the Merck Frosst Centre for Therapeutic Research.

Leadership accomplishments include rapid characterization and selection of viable development candidates, which she established through close collaboration with the discovery groups in basic research. Her product development efforts, which lead to worldwide regulatory approval of several products, include SINGULAIR®, Merck’s oral asthma therapy, and VIOXX® and ARCOXIA™, two Cox-2 inhibitors for the treatment of pain, osteoarthritis, and rheumatoid arthritis. In addition to her responsibilities in the Canadian research labs Dr. Vadas was also responsible for several years for Merck's ophthalmic drug development group, located in France. Dr. Vadas' main scientific interests are in the area of pharmaceutics. She served as a Member of the Advisory Board at Hungarian Innovative Technologies Fund. She was an Adjunct Professor of Pharmaceutics at the Faculty of Pharmacy, University of Montreal 1995 to 2005 and currently she is an Independent Consultant.

Dr. Vadas earned her Undergraduate degree in Colloid and Surface Chemistry in Budapest, Hungary and a Ph.D. in Physical Chemistry from McGill University in Montreal and was a postdoctoral fellow in the Department of Biochemistry at McGill University and in the Montreal Neurological Institute prior to joing Merck. Dr. Vadas is a Fellow of the American Association of Pharmaceutical Scientists and a Fellow of the Canadian Society for Pharmaceutical Sciences.

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Scott A. Reines, M.D., Ph.D, - Chief Medical Officer

Scott has broad drug development experience obtained as a senior executive in pharmaceutical R&D, and currently consults for biotech and pharmaceutical companies as well as for venture capital firms. In addition, he is a member of the Board of Directors of KidsPeace Inc., a non-profit national psychiatric service provider that addresses the behavioral and mental health needs of children.

During his career Dr. Reines has been responsible for the development of many important drugs in five different therapeutic areas. As Senior Vice President for CNS, Pain, and Translational Medicine at Johnson & Johnson, he oversaw the development and approval of INVEGA® and INVEGA SUSTENNA® for schizophrenia, NUCYNTA® for severe pain, REMINYL® extended release for Alzheimer’s disease, RISPERDAL CONSTA® for schizophrenia and bipolar disorder, RISPERDAL® for treatment of the behavioral manifestations of autism, and TOPAMAX® for prevention of migraine headache and treatment of epilepsy.

Prior to J&J, Dr. Reines served at Merck as Vice President, Clinical Research with responsibilities for Psychopharmacology, Neuropharmacology, Gastroenterology, and Ophthalmology. At Merck he was responsible for the development of EMEND® for prevention of chemotherapy-induced nausea and vomiting, MAXALT for treatment of migraine headache, SINEMET-CR® for Parkinson’s disease, and TRUSOPT®, COSOPT®, and TIMOPTIC-XE® for prevention of glaucoma. While at Merck he also oversaw the conduct of the first large, multicenter trial of a COX-2 inhibitor for prevention of Alzheimer’s disease.

Dr. Reines received his B.S. magna cum laude in chemistry from Cornell University, his Ph.D. in bio/organic chemistry from Columbia University, and his M.D. from Albert Einstein College of Medicine. He completed a psychiatric residency at Montefiore Hospital in New York City and obtained Board certification in psychiatry. He recently served as the first industry co-chair of the Neuroscience Steering Committee, Foundation for NIH Biomarkers Consortium, and previously served for five years on the National Drug Abuse Advisory Council and its Bioethics Task Force.

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Peter Whitney Vanderklish, Ph.D. - Chief Scientific Officer

Dr. Vanderlish has a track record of expertise and significant contributions in synaptic neurobiology, intellectual disability, and the regulation of local protein synthesis within neurons. During graduate work (UC Irvine), he helped establish that long term potentiation (LTP) is expressed by changes in the postsynaptic element – that is, in dendritic spines – and that postsynaptic adhesion molecules called integrins play a key role in consolidating such changes via the restructuring of synapses.

He has conducted particularly impactful work on the molecular basis of Fragile X syndrome – the most common form of inherited intellectual disability, and leading known cause of autism – which has identified synaptic and molecular defects and potential new targets for therapeutic intervention. In other work, he has made significant contributions to our understanding of how the profile and rate of protein synthesis at synapses is regulated by neurotrophic factors, cytoskeletal and adhesion molecule determinants of synaptic structure, RNA-binding proteins, and microRNAs. Dr. Vanderklish holds positions as Associate Professor in the Dept. of Molecular Medicine at The Scripps Research Institute, as a Visiting Professor in Anatomy and Neurobiology at UC Irvine, and Lecturer at The University of San Diego.

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Josh Swartz - Director

Josh Swartz is the Co-Founder & President of Catalyst Sports & Media and is responsible for the company’s esports and investment operations. In his former role as President of Relativity Sports, he managed the day-to-day operations of the company and oversaw each sport specific division, which in total represented over 400 clients.

Prior to joining Relatively, Mr. Swartz was the COO of Wasserman Media Group, a sports marketing and talent management company, where he managed all strategy and corporate governance matters. Over the course of his career, Josh has led over 35 acquisitions and has become an experienced investor in early stage sports and media companies. Mr. Swartz holds a JD degree from Harvard Law School and a B.A. in Political Science from the University of California at Berkeley.

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Spinogenix Awarded NIH Grant to Develop Novel Neurorestorative Therapeutics for Alzheimer’s Disease

San Diego, CA, May 1 2018: Spinogenix, Inc., a preclinical stage, privately-held pharmaceutical company developing first-in-class drugs to reverse synapse loss and restore connections lost to neurodegenerative diseases, today announced a grant award by the National Institute of Health (NIH). The grant award will fund research and development of a novel family of compounds to help restore the brain connections and functions lost in Alzheimer’s disease (AD) and related neurodegenerative disorders.

AD is a degenerative brain disease and the most common cause of dementia - accounting for an estimated 60 to 80 percent of dementia cases. The Alzheimer’s Association 2018 Report estimates that there will be 5.7 million people with dementia in the United States in 2018 with an estimated 14 million new cases of dementia by 2050, equivalent to one person every 3.2 seconds.

“Spinogenix is extremely pleased to receive this grant award which provides rigorous peer-reviewed validation of our innovative approach to tackle AD. This funding will help us further develop our drug candidates and bring a promising new class of therapeutics to the marketplace to treat not only AD but also related diseases that involve a loss of dendritic spine synapses”, said Stella Sarraf, Ph.D., Founder and Acting Chief Executive Officer.

“Loss of dendritic spines is a major driver of cognitive decline in all neurodegenerative diseases as well as normal aging,” said Franz Hefti, Chairman of the Board. “Spinogenix is targeting the loci of changes underlying memory formation.”

Currently, none of the available treatments for AD or other neurodegenerative diseases reverse synapse loss. With the support of this NIH grant, Spinogenix aims to further develop a new class of neurorestorative therapeutics to help treat patients with AD.

About Spinogenix

Spinogenix was founded in 2016 to address the urgent clinical need for novel drugs to combat diseases and conditions involving synaptic aging and loss. Our neurorestorative compounds are designed to restore synapses in order to enhance brain connections and improve memory. Current development is focused on therapeutic treatments for AD and traumatic brain injury/concussion. More information on Spinogenix can be found at www.spinogenix.com.

Disclosure

This project is supported by the National Institute on Aging of the National Institutes of Health under award number R43AG058278. The content is solely the responsibility of the Company and Principal Investigators and does not necessarily represent the official views of the National Institutes of Health.