InMed Pharmaceuticals Inc. (NASDAQ: INM)

InMed Pharmaceuticals Inc. (NASDAQ: INM) is a global leader in the manufacturing and clinical development of rare cannabinoids. InMed is a clinical stage company developing cannabinoid-based pharmaceutical drug candidates, as well as manufacturing technologies for pharmaceutical-grade rare cannabinoids.

The company is dedicated to delivering new therapeutic alternatives to treat conditions with high unmet medical needs. The company is also developing a proprietary manufacturing technology to produce pharmaceutical-grade rare cannabinoids in the lab and has recently announced an LOI to acquire a leading rare cannabinoid manufacturer

Research and Technology

There are more than 100 rare cannabinoids found in only trace amounts in the cannabis plant, together making up less than 1% of the plant’s biomass. InMed is initially focused on the therapeutic benefits of cannabinol (CBN) in diseases with high unmet medical need. Preclinical studies of CBN demonstrated an excellent safety profile and showed CBN has potential for therapeutic benefit over other cannabinoids such as tetrahydrocannabinol (THC) and cannabidiol (CBD).

Evidence suggests there may be great therapeutic potential in rare cannabinoids. Each has a specific chemical structure, and different cannabinoids have been observed to have distinct physiological properties in humans, including therapeutic potential for specific diseases as well as unique safety profiles. CBN is the active pharmaceutical ingredient (API) in InMed’s two lead programs for dermatological and ocular diseases.

InMed’s most advanced compound, INM-755, is a CBN topical cream under clinical development for the treatment of epidermolysis bullosa, a severe genetic skin disorder. To date, INM-755 has been evaluated in two Phase 1 clinical trials in healthy volunteers. InMed has filed Clinical Trial Applications in several countries as part of a global Phase 2 clinical trial of INM-755 (cannabinol) cream in epidermolysis bullosa. Responses from the National Competent Authorities and Ethics Committees are expected throughout the summer of 2021.

InMed is also involved in developing INM-088, an ocular CBN formulation being researched for the treatment of glaucoma, the second leading cause of blindness in the developed world. InMed is currently evaluating several formulations to deliver CBN into the eye to address issues of dosing frequency, side effects and treatment penetration. INM-088 is being designed for topical delivery to the eye. This localized delivery results in very little drug being absorbed or migrating into the bloodstream, thus minimizing potential adverse side effects. INM-088 shows promise to reduce intraocular pressure and provide neuroprotection of the eye.

Manufacturing

The limited availability of rare cannabinoids like CBN makes them economically impractical to extract directly from the plant for pharmaceutical use. InMed is developing IntegraSyn, a cannabinoid synthesis manufacturing system to create rare cannabinoids in the lab that are bioidentical to the compounds derived from the cannabis plant. IntegraSyn uses multiple standard pharmaceutical processes and has achieved a cannabinoid yield of 5 grams per liter, surpassing commercial viability and significantly exceeding currently reported industry yields. InMed is now focusing on manufacturing scale-up to larger batch sizes while continuing process optimization, targeting increased cannabinoid yield and further reducing overall cost of goods.

BayMedica Inc. Acquisition

On June 29, 2021, InMed announced it had entered into a non-binding letter of intent to acquire BayMedica Inc., a private company based in Nevada and California that specializes in the manufacture and commercialization of rare cannabinoids.

As noted in the news release, BayMedica is a revenue-stage biotechnology company leveraging its significant expertise in synthetic biology and pharmaceutical chemistry to develop efficient, scalable and proprietary manufacturing approaches to produce high quality, regulatory-compliant rare cannabinoids for consumer applications. BayMedica is currently commercializing the rare cannabinoid CBC (cannabichromene) as a B2B supplier to distributors and manufacturers marketing products in the health and wellness sector. BayMedica is planning additional rare cannabinoid launches for the coming year.

Pursuant to the indicative terms of the LOI, InMed and BayMedica intend to negotiate and enter into a definitive agreement under which InMed would acquire 100% of BayMedica in exchange for 1.6 million InMed common shares to be issued to BayMedica’s equity and convertible debt holders, with any such issued InMed common shares being subject to a six-month contractual hold period.

Market Outlook

There is a rapidly growing demand for rare cannabinoids. However, their low natural concentration makes traditional harvesting of these compounds cost prohibitive. Biosynthesis allows production of rare cannabinoids in the lab that are bioidentical to compounds found in nature, with significantly higher yields which reduce costs. Biosynthesis can produce pharmaceutical-grade, bioidentical, THC-free compounds at a cost that’s 70 to 90 percent less than wholesale prices of naturally harvested rare cannabinoids.

Cannabinoid-based pharmaceuticals are expected to overtake the market as rare cannabinoids become less expensive and more available. According to Statista, the value of the consumer market for cannabinoid-based pharmaceuticals in the United States is forecast to grow to $25 billion by 2025 and to $50 billion by 2029, with cannabinoid-based pharmaceuticals used to treat health conditions including pain, respiratory conditions, autoimmune conditions and more.

Management Team

Eric A. Adams has been CEO and president of InMed since June 2016. He has more than 25 years of experience in establishing corporate entities, capital formation, global market development, mergers and acquisitions, licensing and corporate governance. He previously served as CEO at enGene Inc. Prior to enGene, he held senior positions in global market development with QLT Inc. (Vancouver), Advanced Tissue Sciences Inc. (La Jolla, CA), Abbott Laboratories (Chicago, IL) and Fresenius AG (Germany).

Bruce S. Colwill is InMed’s CFO. He has more than 25 years of financial leadership experience in public and private companies. Prior to InMed, he served as CFO of General Fusion Inc., a private clean energy company. He was also CFO at Entrée Resources Inc., a mineral exploration company, from 2011 to 2016. He has held CFO roles at Neuromed Pharmaceuticals Ltd., Response Biomedical Corp, Forbes Medi-Tech Inc. and Euronet Worldwide Inc.

Alexandra D.J. Mancini is Senior Vice President, Clinical and Regulatory Affairs at InMed. She has more than 30 years of global biopharmaceutical research and development experience. She has been an executive with numerous biotech companies, including senior vice president of Clinical and Regulatory Affairs at Sirius Genomics; senior vice president of Clinical and Regulatory Affairs at INEX Pharmaceuticals; and vice president of Regulatory Affairs at QLT Inc.

Eric C. Hsu is Senior Vice President, Pre-Clinical Research and Development at InMed. He joined InMed with more than 18 years of scientific leadership experience in the field of gene therapy. He has held various positions within enGene Inc., including vice president of Research and vice president of Scientific Affairs and Operations. He received his Doctorate from the Department of Medical Biophysics at the University of Toronto.

Michael Woudenberg is Vice President, Chemistry, Manufacturing and Controls at InMed. He has more than 20 years of successful drug development, process engineering, GMP manufacturing and leadership experience. He has held positions with 3M, Cardiome Pharma, Arbutus Biopharma and, most recently, was Managing Director of Phyton Biotech LLC.

Investment Considerations

• InMed has a world class leadership team with a successful track record of drug development and commercialization.
• The company recently announced closing of a $12 million private placement.
• InMed has a solid and expanding intellectual property portfolio with multiple patents filed.
• The company recently signed an LOI to acquire rare cannabinoids manufacturer BayMedica.
• InMed retains all commercial rights to its IntegraSyn manufacturing system.
• InMed has filed clinical trial applications in several countries as part of a Phase 2 clinical trial of INM-755 (cannabinol) cream in epidermolysis bullosa.
• The consumer market for cannabinoid-based pharmaceuticals in the United States is forecast to grow to $25 billion by 2025 and to $50 billion by 2029.