Lobe Sciences

Overview

Mental health and trauma impact a significant amount of adults in the United States, with 52.9 million adults experiencing a mental illness such as severe forms of anxiety with 12 million adults experiencing post-traumatic stress disorder (PTSD). Unfortunately, treatment for mental illnesses is often ineffective, especially for trauma-based conditions. Psychedelics have emerged as a promising treatment for many mental illnesses, and two-thirds of physicians believe one psychedelic, psilocybin, has therapeutic benefits.

Several neurological disorders, such as brain trauma, have shown promising results from psilocybin treatment. Mental illnesses such as major depression have also indicated encouraging results from psilocybin. Psychedelic compounds are generally considered non-addictive and suitable for the treatment of a wide variety of medical conditions. Companies that innovate safe and effective psychedelic medications are leading the charge toward a new era of mental health treatment.

Lobe Sciences (CSE:LOBE,OTCQB: LOBEF) is a Canadian-based life sciences company entering clinical stage development for proprietary, patent-pending psilocin compounds to treat neurological and brain diseases. Psilocin is known to be the psychologically active component of psilocybin. In 2022 the company announced it is entering human clinical trials for its proprietary psilocin compound L-130. The company is positioned to initiate additional clinical trials in Australia and plans to file an investigational new drug application (IND) with the US FDA in 2023.

Prior to the work performed at Lobe Sciences, it was generally believed that the psilocin molecule could not be stabilized outside nature’s “prodrug” psilocybin. Lobe Sciences has developed multiple novel stable psilocin compounds. The L-130, for example, is a stabilized and patent-pending form of psilocin. Lobe Sciences received regulatory clearance to conduct Phase 1 study which is a combination of safety and pharmacokinetics evaluation of a fixed dose of L-130.

The company's exclusive discovery and manufacturing partner Quality Chemical Laboratories LLC (QCL) initiated commercial formulation activities for L-130. QCL, in collaboration with Clearway Global, LLC, will prepare the chemical, manufacturing and control section of the investigational new drug application. The material produced at QCL will be used in the recently announced Phase IIIa study to evaluate L-130 as a treatment for chronic cluster headaches, a debilitating orphan disease. QCL agrees to supply Lobe Sciences research and commercial quantities of two new chemical entities, L-130 and L-131 under an exclusive arrangement.

Lobe Sciences’ vision is to administer psilocin compounds at home, in the emergency department, or clinic. This will allow patients to remain with their primary physician and not be required to be confined in a clinic for eight or more hours to receive a hallucinatory dose of the psychedelic. The company plans to develop psilocin-based therapeutics for the treatment of neurologic disorders, such as severe anxiety and PTSD. Research data from the company indicates that its combination therapeutic method is significantly more effective than monotherapy for both mTBI and PTSD.

Company Highlights

• Lobe Sciences is a life sciences company headquartered in Canada with North American operations.
• The company is entering clinical-stage development for proprietary patent-pending psilocin compounds, developing psychedelic therapeutics as an integrated biotech company.
• Lobe Sciences’ therapeutic development is focused on neurologic and brain diseases. Recent pre-clinical data has demonstrated the effectiveness of these treatments.
• Provisional patents for the Preparation of Stable Psilocin Prodrugs and Analogues and their Uses
• Lobe Sciences has partnered with Clearway Global to assist with developing, implementing and monitoring its manufacturing, regulatory and clinical programs.
• Lobe has completed the synthesis of bulk L-130 (a molecular modification of naturally occurring psilocin) and of the clinical supplies to be used in upcoming trials. Sufficient quantities of L-130 have been manufactured for the company’s first two Phase 1 programs.
• Lobe Sciences filed a provisional patent for the preparation and use of its proprietary and stable psilocin-related compounds.

Management Team

Philip J. Young - Chairman & CEO

Philip Young is an accomplished CEO and innovative professional with 25 years of expertise in senior executive management and board roles, with significant mergers and acquisitions and equity financing experience. He has a proven track record in the biotech, medtech and pharmaceutical industries with expertise in dealing with FDA/regulatory frameworks as well as new device and therapeutics development. From 2015 until 2019, Young was the founder, chairman, and CEO of Exactus Inc., an OTCQB-listed company he successfully transitioned from a medical technology company to a farming-focused hemp-derived CBD company. Prior to Exactus, Young was the president, CEO, and director of AmpliPhi Biosciences Corp. (now Armata Pharmaceuticals Inc.), a global biopharmaceutical company. He was also previously the President, CEO and director of Osteologix Inc., where he was responsible for directing and managing all facets of the global pharmaceutical development company. He is the former chief business officer and executive vice-president of Insmed Inc., where he directed all financing, corporate and commercial communications activities. Prior thereto, he was the vice-president and general manager of Neurex Corp., where he was involved with the negotiations for its US$700 million acquisition by Elan Corporation.

Brian Zasitko - CFO

For over 13 years, Brian Zasikto has worked in a number of private and public companies in sectors such as cannabis, agriculture, manufacturing and utility industries. Zasitko is well-versed in financial reporting and corporate governance and capital markets.

Dr. Maghsoud Dariani - Chief Science Officer

Dr. Maghsoud Dariani has extensive experience working with a wide range of life science companies. He is the current president and CEO of Semorex Inc., a privately held company focused on novel therapeutics for cancer. Dariani was previously the president of Focus Pharmaceuticals, Inc., where he managed the development and approval of drug products and notched an FDA approval for another clinical evaluation stage.

Michael Petter - Director

Michael Petter is an accomplished leader and entrepreneur in the psychedelics and cannabis industry, co-founding and acting as a director of several companies that successfully completed M&A transactions. His executive advisory skills focus on providing guidance on strategy, operations, finance and logistics. Since January 2009, he has been the managing director of Eyvo eProcurement Solutions, a US-based private company that is a leading eProcurement provider in the SaaS space. He also runs a business mentoring program that assists businesses and individuals with change management. Petter was co-founder and director of Eleusian Biosciences Corp. and co-founded and was a director of Tassili Life Sciences Corp. which was acquired by CSE-listed Champignon Brands Inc. in March 2020. Petter has independent board experience being chairman of a compensation committee and a member of an audit committee.

Baxter F. Phillips III - Director and Chairman of the Audit Committees

Baxter Phillips has more than 20 years of experience leading multinational corporate strategy and finance in the biotechnology and pharmaceutical industry. He has held key positions as chief executive officer of UK-based Camallergy, CEO of Neurogastrx, and chief business officer of AmpliPhi Biosciences (now Armata Pharmaceuticals: ARMP).

Dr. Mark A. Geyer Ph.D - Scientific Advisor

Dr. Mark Geyer is a distinguished professor of psychiatry and neurosciences emeritus at the University of California San Diego (UCSD) and directs the neuropsychopharmacology unit of the VISN 22 Veterans Administration Mental Illness Research, Clinical, and Education Center. He is respected internationally for his research on the psychophysiology, neurobiology, and pharmacotherapy of schizophrenia and bipolar disorder. Geyer's broad experience as a researcher, grant reviewer, journal editor, and teacher lends invaluable scientific and professional expertise to several organizations, as he provides leadership to develop strong programs in the behavioral psychopharmacology and clinical applications of psychedelic agents.

Charles S. Grob, MD - Scientific Advisor

Dr. Charles S. Grob is a professor of psychiatry and pediatrics at the UCLA School of Medicine. He held faculty positions at the Johns Hopkins School of Medicine and the University of California at Irvine. He has conducted approved clinical research with psychedelics since the early 1990s. From 2004 to 2008 he was the principal investigator of the first study in several decades to examine the use of a psilocybin treatment model for patients with advanced-cancer anxiety. He has also conducted research into the range of effects of MDMA, in both normal volunteers and in a selected subject population of adult autistics with severe social anxiety. And, he has conducted a series of ayahuasca research studies in Brazil. Over the last thirty years, Grob has published numerous articles on psychedelics in the medical and psychiatric literature and he is the editor of Hallucinogens: A Reader (Putnam/Tarcher, 2002), co-editor (with Roger Walsh) of Higher Wisdom: Eminent Elders Explore the Continuing Impact of Psychedelics (SUNY Press, 2005), and co-editor (with James Grigsby) of the recently published Handbook of Medical Hallucinogens (Guilford Press, 2021). He is a founding board member of the Heffter Research Institute.

Benjamin Kelmendi, MD - Scientific Advisor

Benjamin Kelmendi is a psychiatrist and an associate professor in the department of psychiatry at Yale University School of Medicine. His primary clinical expertise is in PTSD, depression, OCD, and the endocannabinoid system. He is the co-founder of the Yale Psychedelic Science Group. He leads a research program focused on the therapeutic potential of psychedelic medicines, across a range of psychiatric diagnoses. He is currently investigating the effects of psilocybin on the neurocircuitry implicated in the development, maintenance, and treatment of patients with OCD. He is also exploring the effects of MDMA on brain activation and neural network organization in PTSD to understand the relationship between MDMA-induced neural changes and the acute cognitive and behavioral effects of the drug.

Albert “Skip” Rizzo, Ph.D - Scientific Advisor

Albert “Skip” Rizzo is a clinical psychologist and director of Medical VR at the University of Southern California Institute for Creative Technologies. He is also a research professor with the USC department of psychiatry and school of gerontology. Over the last 25 years, Rizzo has conducted research on the design, development and evaluation of virtual reality systems targeting the areas of clinical assessment, treatment and rehabilitation across the domains of psychological, cognitive and motor functioning in both healthy and clinical populations. This work has focused on PTSD, TBI, Autism, ADHD, Alzheimer’s disease, stroke and other clinical conditions. He has also driven an extensive research program on the use of intelligent virtual human agents for clinical training, healthcare information support, and clinical assessment. In spite of the diversity of these clinical R&D areas, the common thread that drives all of his work with digital technologies involves the study of how virtual reality simulations can be usefully applied to human healthcare beyond what’s possible with traditional 20th-century methods.

Ilan Hayman - Advisor

Ilan Hayman has played a pivotal role in the general management of healthcare businesses including a private cosmetic surgery chain and the commercialisation of a breakthrough skincare range. He successfully led the development of these products from concept through to product commercialization. Most recently Hayman oversaw a group of national medical centers. His career in operations management was triggered by his valuable experience as part of the risk and controls solutions practice at PricewaterhouseCoopers. Specifically, Hayman’s passion is assisting the medical fraternity in their practice management and business administration functions. Hayman’s ambition is to work in a role that utilizes his analysis expertise enriched by his exposure to the commercial side of business. He has a passion for assisting community organizations and sits on several boards of not-for-profit organizations. He also holds Bronze and Silver Duke of Edinburgh awards and brings along a unique set of community and industry-related experience.

Bart Oates - Advisor

Bart Oates, Esq., is a three-time Superbowl champion, who graduated magna cum laude with a Juris Doctor degree from Seton Hall during his off-season. Prior to his NFL career, he earned a BS in Accounting from the Marriott School of Business at BYU and was inducted into their athletic Hall of Fame in 1992. Oates was selected to five Pro Bowls during his NFL career and to the UPI All-NFC team three times. He is now the president of the NFL Alumni Association which offers former players a diverse package of medical, business and legal services to help keep them and their families healthy, productive, and connected to their former teammates.

Gilberto Jesús Mendoza - Advisor

Gilberto Jesús Mendoza is currently the president of the World Boxing Association. Mendoza began his career as a lawyer and an engineer and has been working with the WBA since 2015. His priority has always been to give opportunities to the most vulnerable regions of the world. He has spent time in close contact with athletes since he was a child and has actively participated in the intention to rescue amateur boxing. Mendoza is the proud creator of “Un Solo Boxeo” (Only One Boxing), a program that promotes the integration of professional boxing. He also created the Future WBA Champion, a project that has given space to thousands of boxers in their preparation stage for the Tokyo Olympic Games. Mendoza’s goal is the growth and development of boxing, as well as its adaptation to change.