Overview

Mental health and trauma impact a significant amount of adults in the United States, with 52.9 million adults experiencing a mental illness and 12 million adults experiencing 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 towards a new era of mental health treatment.

Lobe Sciences (CSE:LOBE,OTCQB: LOBEF) is a Canadian-based life sciences company focused on researching and developing psychedelic medicines. The Company focuses on the clinical development of medicines to treat neurological disorders and brain trauma. Recently, Lobe Sciences announced the publication of a PCT patent application for its combination therapy for mTBI and PTSD. The Company’s mission is to identify and develop transformative new methods, medicines to improve brain health and provide new pathways for treating brain injuries and neurological disorders. Lobe Sciences is actively strengthening its balance sheet in Q1 2022.

Lobe Sciences undertakes the development of innovative medicines to treat mental health disorders and improve well-being while building a growing portfolio of intellectual property to protect our therapies. The company recently updated its scientific advisory board with experts in virtual reality, electronic engineering, and technologists to strengthen its pursuit of therapeutic VR devices.

Psychedelics (serotonergic hallucinogens) are powerful psychoactive substances that alter perception and mood and affect numerous cognitive processes. They are generally considered physiologically safe and do not lead to dependence or addiction. NAC is a dietary supplement derived from the amino acid L-cysteine. Taking NAC increases the level of glutathione, a potent antioxidant and anti-inflammatory molecule, in cells. Glutathione’s function is to protect cellular compounds such as DNA and prevent damage to them from reactive oxygen species and inflammatory cytokines. It is also used as an antidote for acetaminophen overdose.

Lobe Sciences’ vision is to administer the psilocybin and N-acetylcysteine (“NAC”) in doses that will be administered 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 psilocybin-based therapeutics in combination with NAC for the treatment of mild traumatic brain injuries (“mTBI”) and post-traumatic stress disorder (“PTSD”) and devices for the efficient application of these medications. Recent research data from the Company indicates that its combination therapeutic method is significantly more effective than monotherapy for both mTBI and PTSD.

The first focus is on identifying the largest non-hallucinatory dose of psilocybin in combination with NAC for treating mTBI and PTSD and other neurological disorders. The Company anticipates that it will file a Pre -IND meeting request with the FDA in Q3 of 2022 and once it is approved it plans to file the IND. This will lead to the first of several Phase 1 clinical trials to begin in Q4 of 2022.

Company Highlights

• Lobe Sciences is a life sciences company headquartered in Canada with North American Operations.
• The Company is developing psychedelic therapeutics as an integrated biotech company
• Lobe Sciences therapeutic development is focused on mild traumatic brain injury(mTBI)and posttraumatic stress disorder (PTSD) associated with head trauma. Recent pre-clinical data has demonstrated the effectiveness of these treatments.
• A provisional patent for methods and compositions for treating mTBI PTSD alone with 3,4 MDMA plus NAC has been filed.
• Lobe Sciences has collaborated with a multidisciplinary team from the University of Miami which conducted a preclinical study on the effect of the treatment of mTBI with PTSD or PTSD alone based on the combination of psilocybin and NAC. The Company has a Joint Venture with Virtual Psychedelics Inc. to develop the Krysalis System which has reached the early prototype stage. This is a major step forward as the team works to develop the industry leading platform for use with psychedelic and virtual therapy and counseling content in physician offices and clinics as well as integrating into the newly expanding Metaverse.
• Lobe will investigate the safety and tolerability of an oral drug candidate, L-130 (a molecular modification of naturally occurring psilocin) and measure absolute pharmacokinetics of this new chemical entity (NCE) given alone and in conjunction with NAC. Following the successful completion of the first-in-man safety trials, a Phase Ib/IIa study will be implemented in healthy volunteers and patients.

Management Team

Philip J. Young - CEO & Director

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, Mr. Young was the Founder, Chairman, and CEO of Exactus Inc. (“Exactus”), an OTCQB listed company he successfully transitioned from a medical technology company to a farming focused hemp-derived CBD company. Prior to Exactus, Mr. 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. Mr. Young holds a Bachelor’s of Science from James Madison University.

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. Mr. Zasitko is well versed in financial reporting and corporate governance and the capital markets.

Dr. Maghsoud Dariani - Chief Science Officer

Dr. 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. Mr. 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.

Jonathan Gilbert - Executive Director

Jonathan Gilbert was the founder and CEO at Tassili Life Sciences Corp., a biotech firm conducting research with psilocybin. Gilbert is also the founding CEO of Eleusian Biosciences, which Lobe Sciences acquired in June 2020, and will play an integral role in the company’s growth strategy moving forward.

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

Dr. 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. Dr. 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

Charles S. Grob, M.D. is a Professor of Psychiatry and Pediatrics at the UCLA School of Medicine. He previously 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 2004-2008 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, Dr. 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 is a psychiatrist and an Associate Professor in the Department of Psychiatry at the 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 Dept. of Psychiatry and School of Gerontology. Over the last 25 years, Skip 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 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 production commercialization. Most recently Ilan 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 (PwC). Specifically, Ilan’s passion is assisting the medical fraternity in their practice management and business administration functions. Ilan’s ambition is to work in a role that utilizes his analysis expertise enriched by his exposure to the commercial side of business. Ilan 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. Bart was selected to five Pro Bowls during his NFL career and to the UPI All-NFC team three times. Bart 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. Mr. 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. Mr. 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. Mr. Mendoza’s goal is the growth and development of boxing, as well as its adaptation to change.

Krysalis System Development Advisory Team

Alex McDowell - Advisor

Award-winning designer, storyteller, and founder and creative director of Experimental Design where McDowell and his team design immersive story worlds for industries and institutions. He is simultaneously a professor of practice at USC School of Cinema, where he directs the World Building Media Lab and World Building Institute and teaches world building as a media and platform-agnostic narrative design practice. Alex is also known as one of the top Hollywood production designers, having worked on some of the biggest visionary Hollywood blockbusters such as Steven Spielberg's "Minority Report".

Jon 9 - Advisor

Jon 9 is a Creative Technologist who handles large-scale digital display projects, streaming immersive spaces, content creation and post-production management for complex systems. He's realized massive projects including Cirque du Soleil: Beatles LOVE at The Mirage Las Vegas, installations with Disney, and many others with icons and mega-brands from Michael Jackson and Aretha Franklin to Audi and The Emmy Awards. His expertise is rooted in developing experiential media spaces that require new techniques and technologies.

Austin Blaisdell - Advisor

Austin Blaisdell is a design strategist and art director who uses 3D printing, Virtual Reality, and the entire digital universe to project visions spanning all arts-related genres. His spatial design, visual direction, and design solutions may be experienced internationally, at exhibitions from Los Angeles to New York to Paris. Kent Noonan is an Electronic Engineer whose expertise spans all areas of design and manufacturing, lasers and optics, high performance electronics and tough industrial devices, alternative healing with light and electromagnetic frequencies, free energy devices and alternate fuels, plasma, cymatics, and structured water research.

Erik Larson - Advisor

Erik Lasrson is an inventor, design engineer, musician, instrument builder, and entrepreneur. His professional specialties include business development, business management, patent and IP development, product development, technology integration, systems design, and team building.

Casey Atteberry is a mathematician striving to translate material in an approachable way to people of all ages and levels of interest. He has been an independent math and acoustical physics research scientist for nearly two decades, studying concepts from quantum computation to cymatics and fluid dynamics.

Casey Atteberry - Advisor

Casey Attebery is a mathematician striving to translate material in an approachable way to people of all ages and levels of interest. He has been an independent math and acoustical physics research scientist for nearly two decades, studying concepts from quantum computation to cymatics and fluid dynamics.