Company Description

We are a pharmaceutical tech company that operates under two main segments: Pharmaceuticals and Consumer Wellness. In the Pharmaceutical segment, we develop innovative drug delivery technologies for both human and animal health applications, based on advanced cannabinoids science, to treat various conditions to improve quality of life. Supported by pre-clinical studies conducted in various animal models, but not yet verified in humans, our synthetic Cannabidiol-loaded Liposome injection Platform (LPT-CBD) facilitates exact dosing and the prolonged and controlled release of synthetic CBD into the blood stream. While determinations of safety and efficacy are solely within the authority of the FDA and comparable foreign regulatory bodies, we expect, based on various scientific studies, including a report of the World Health Organization, that cannabidiol in general will avoid many of the risks of addiction, tolerance, and dependency, commonly associated with opioids. Our LPT-CBD is in late pre-clinical stage of development, and we have initiated the FDA regulatory review process for this non-opioid alternative for chronic pain management. The process has been initiated with a successful pre-IND meeting that structured our development plan towards IND submission. We intend to submit an IND application for our initial Phase 1a study following the completion of LPT-CBD scale-up activities, which are expected to commence approximately three months following the completion of this offering and are expected to take approximately one year. Upon completion, we will conduct a Good Laboratory Practice (GLP)-compliant single-injection preclinical safety study, with final reporting anticipated within 6–8 months. Following the availability of the safety data, we will submit the IND application to the FDA, including the clinical protocol and safety report. If the safety results are deemed acceptable, and assuming no clinical hold is issued, the Phase 1a first-in-human study will commence 30 days post-submission. During Phase 1a studies, we will collect PK and exposure data of LPT-CBD to form a scientific bridge to the listed drug Epidiolex, which we intend to submit to the FDA in support of a 505(b)(2) application. This process is estimated to take 6–8 months and will run in parallel with the Phase 1a studies. Phase 1b studies are intended to begin immediately following the approval of Phase 1a study results and the completion of a repeated-dose GLP safety study. Synthetic CBD is known to have high purity, batch to batch consistency and to date, regulatory superiority without THC, and does not involve the use of the cannabis plant. The novelty of LPT-CBD lays in its ability to be injected under the skin (subcutaneously) once a month facilitating the prolonged release of synthetic CBD to the blood stream for up to four weeks. This has been supported by various preclinical studies conducted in both small and large animal models, although it has not yet been confirmed in clinical studies. In the Consumer Wellness segment, we develop and market a wide portfolio of innovative and high-performance self-care and CBD beauty products to promote a healthier lifestyle. Also under this segment, we have established a joint venture company, B.I. Sky. We hold 60% of B.I. Sky and Brandzon holds the remaining 40%. Roni Kamhi, our COO, is the chief executive officer and a co-founding director of B.I. Sky. e which focuses on developing and marketing advanced non-CBD personal care and beauty products in the United States, starting with online marketplaces, with plans to expand to direct-to-consumer sales, and finally evolving to brick & mortar storefronts. Revenues in the United States are attributed primarily to sales of B.I. Sky non-CBD personal care products. In addition, in our Pharmaceuticals segment, Innocan sells CBD personal care products through distribution in Europe. Our patent portfolio includes 31 published patents granted and pending across eight families. We seek composition of matter describing pharmaceutical entity protection for our liposomal cannabinoids and uses thereof’ patent, which is currently in a pending status worldwide and granted in India. Three additional granted patents are related to our pain relief topical compositions and the rest of our patents related to additional cannabinoid compositions and use thereof are at pending status. --- We are a Canadian federal corporation with headquarters in Calgary, Alberta and Herzliya, Israel. We were incorporated on May 31, 2018, under the name Innocan Pharma Corporation. Our registered and records offices are located at 1015, 926 – 5 Avenue SW, Calgary, Alberta T2P 0N7, Canada, and our principal executive office are located at Arik Einstein Street 3, Herzliya, 4659071, Israel. Our telephone number in Canada is +1 (516) 210-4025. Our website address is www.innocanpharma.com.