| InMed Pharmaceuticals Inc. (“InMed” or the “Company”) (Nasdaq: INM), a leader in the research, development, manufacturing and commercialization of rare cannabinoids, today announced financial results for the third quarter of the fiscal year 2022 which ended March 31, 2022. “The third quarter of fiscal 2022 saw noticeable advancements across all of our programs, including commencing sales of the rare cannabinoids CBDV and CBT as raw ingredients for the health and wellness industry,” says Eric A. Adams, InMed President & CEO. “For the remainder of fiscal 2022, we will remain focused on driving our commercial operations by expanding our product portfolio, increasing sales of our existing and new rare cannabinoids, exploring new distribution channels and optimizing our product development and supply chain strategy. We continue to grow revenues and have established a solid platform upon which to build as we commercialize additional high value products. We continue to focus on enhancing our sales and marketing efforts to support increasing demand.” Business Update Commercial Activities In January 2022, InMed announced that it launched B2B sales of cannabicitran (“CBT”) to wholesalers, suppliers and end-product manufacturers in the health and wellness sector via its wholly-owned subsidiary, BayMedica LLC. Subsequent to the quarter end, the Company also commenced sales of the rare cannabinoid cannabidivarin (“CBDV”) in April, marking the third product in the Company’s rare cannabinoid commercial portfolio, which also includes cannabichromene (“CBC”). BayMedica has also begun commercial scale production of its delta-9 dominant tetrahydrocannabivarin (“THCV”) in anticipation of commencing B2B sales. CBDV and THCV are highly anticipated, non-intoxicating rare cannabinoids for which is there is growing interest. Continuing to build out a robust product portfolio is a strategic priority and the Company currently has several additional high-value rare cannabinoids in various stages of development and commercial manufacturing scale-up. By establishing a reliable supply of these rare cannabinoids at commercial scale, innovative product manufacturers and consumer brands now have the ability to deliver improved and differentiated products via product line extensions and formulations designed to increase the performance of their products. In addition to sales of rare cannabinoids as raw ingredients, the Company is also evaluating potential partners and co-development collaborations for novel product development. Formulated cannabinoid products in different delivery forms can help to expand product development options for manufacturers of health and wellness products. Also following the quarter’s end, BayMedica announced they will be supplying the rare cannabinoid THCV for incorporation into Trokie’s proprietary product formulation. This will then be evaluated in Radicle Science’s “Radicle Energy” study on energy, focus/attention, appetite and weight/body mass index (“BMI”). The study is being conducted to provide valuable third party validation to the use case of THCV. Advancing the scientific research and education of rare cannabinoids is a key part of InMed’s commitment to building the framework that supports the Company’s long-term commercial strategy. To support our commercial efforts, in February the Company appointed seasoned business executive, Jerry P. Griffin, as VP of Sales and Marketing. Mr. Griffin has a wealth of experience across various markets and with numerous cannabinoid products, and a proven track record as a seasoned sales executive. He has held several senior positions at both privately and publicly held companies including Fortune 500 companies as a strong strategic leader and has the requisite experience to oversee the commercial ramp-up of B2B sales of rare cannabinoids products to the consumer health and wellness market. Pharmaceutical Development Programs INM-755 for the treatment of Epidermolysis Bullosa (“EB”) Enrollment and patient treatment of the Company’s Phase 2 clinical trial, 755-201-EB, of INM-755 (cannabinol) cream in the treatment of EB, commenced in December of 2021 and is expected to complete during the calendar year 2022. An update on the progress of the EB program is expected in the coming weeks. The 755-201-EB study is designed to enroll up to 20 patients. InMed is evaluating the safety of INM-755 (cannabinol) cream and its preliminary efficacy in treating symptoms and wound healing over a 28-day treatment period. This study marks the first time cannabinol (“CBN”) has advanced to a Phase 2 clinical trial to be investigated as a therapeutic option to treat a disease. INM-088 for the treatment of glaucoma. The Company recently completed a pre-Investigational New Drug (“pIND”) application discussion with the U.S. Food and Drug Administration (“FDA”) regarding manufacturing, preclinical studies and early clinical development plans for INM-088, a cannabinol (“CBN”) formulation in development for glaucoma. The Company has gained alignment with FDA on the design of the initial Phase 1-2 clinical trial to gather preliminary data on the safety and efficacy of INM-088 treatment. The FDA has provided guidance for the development program based on a summary of the available preclinical data, clinical safety data for CBN from the INM-755 program, study designs for additional IND-enabling preclinical studies, and Chemistry Manufacturing and Controls (“CMC”) information. Management expects to file regulatory applications in the first half of the calendar year 2023, to initiate a human clinical trial. The Company continues to advance its pre-clinical research on CBN as a treatment for glaucoma. As referenced in a recent international journal, InMed’s research demonstrates that CBN was effective at providing neuroprotection to the retinal ganglion cells and reducing intraocular pressure in glaucoma models and outperforming several other naturally occurring cannabinoids. New Cannabinoid Analogs In April 2022, the Company announced the publication of a patent application in North America for several cannabinoid analogs. This patent application has broad claims directed to their molecular structure, uses and methods of manufacturing. The patent application covers technology that allows for the creation of libraries of new chemical entities (“NCEs”), which the Company will screen in several in vitro and in vivo models to select therapeutic candidates for advancement. Unlike natural cannabinoids isolated from the plant which are not patentable, these cannabinoid analogs are patentable and may create potential value for the Company. In addition, the Company also initiated a research collaboration agreement with the Department of Biotechnological and Applied Clinical Sciences, University of L’Aquila (Italy) in the laboratory of Dr. Mauro Maccarrone. Dr. Maccarrone’s lab will be screening the Company’s novel cannabinoid analogs to investigate pharmacological properties and potential therapeutic uses. Corporate Today the Company would like to announce that Mr. Bryan Baldasare has joined the Board of Directors effective immediately. Mr. Baldasare is a well-rounded biotech executive with wealth of experience in finance and accounting, financial planning and analysis, treasury management, commercial operations and mergers and acquisitions. Mr. Baldasare spent over 20 years at Meridian Bioscience, most recently as Chief Financial Officer where during his tenure, grew its revenues by over 500%, developed and launched dozens of new products, expanded into a diversified global business with 15 sites in 10 countries. Mr. Baldasare is currently the CFO at Hilltop Companies, a leading supplier to the construction industry. Prior to Meridian, Mr. Baldasare spent over 10 years in public accounting at Arthur Andersen LLP. Mr. Baldasare has a Bachelor’s degree in Business Administration from the University of Cincinnati. As noted earlier, in February, the Company also appointed Jerry Griffin as VP of Sales and Marketing. Financial and Operational Highlights: For the 9 months ended March 31, 2022, the Company recorded a net loss of $10.7 million, or $0.81 per share, compared with a net loss of $6.9 million, or $1.11 per share, for the nine months ended March 31, 2021. Research and development and patents expenses increased by $2.2 million for the nine months ended March 31, 2022 compared to the nine months ended March 31, 2021. The increase in research and development and patents expenses was primarily due to increased activities related to the INM-755 clinical trial and the addition of $0.9 million in our BayMedica segment following the acquisition date. The Company incurred general and administrative expenses of $5.1 million for the nine months ended March 31, 2022 compared with $2.9 million for the nine months ended March 31, 2021. The increase results primarily from the inclusion of BayMedica operating results following the acquisition date and combination of changes including legal fees and investor relation expenses, personnel expenses, substantially higher insurance fees resulting from our listing on the Nasdaq Capital Market. In addition, acquisition-related expenses, which were comprised of regulatory, financial advisory and legal fees, totaled $0.2 million for the nine months ended March 31, 2022 and were included in general and administrative expenses in our InMed segment. At March 31, 2022, the Company’s cash, cash equivalents and short-term investments were $5.9 million, which compares to $7.4 million at June 30, 2021. The change in cash, cash equivalents and short-term investments during the nine months to March 31, 2022, was primarily the result of the July 2, 2021 private placement partially offset by cash outflows from operating activities. At March 31, 2022, the Company’s total issued and outstanding shares were 14,283,848. During the three and nine months ending March 31, 2022, the weighted average number of common shares was 14,151,544 and 13,326,754, which is used for the calculation of loss per share for the respective interim periods. BayMedica Revenue Results subsequent the acquisition of BayMedica in October 2021, are net sales of $0.6 million for the six months ended March 31, 2022 for cannabinoid ingredient sales to wholesalers and product manufacturers in the health and wellness sector. As the nine months ended March 31, 2021 pre-dated the acquisition of BayMedica there are no comparable revenues in the 2021 period. Accordingly, we realized cost of goods sold of $0.3 million for the nine months ended March 31, 2022, with no comparable expenses in 2021, resulting in a gross profit of $0.3 million for the period. Reported sales were impacted this quarter by a delay in the product launches of two new rare cannabinoids, CBDV and THCV. CBDV was launched subsequent to quarter end and the commercial launch of THCV is planned shortly. With the commercialization of these products and additional launches being planned, the Company anticipates revenue growth in the coming quarters. Table 1: Condensed Consolidated Interim Balance Sheets (unaudited): |
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| Table 2: Condensed Consolidated Interim Statement of Operations and Comprehensive Loss (unaudited): |
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| Table 3: Condensed Consolidated Interim Statement of Cash Flows (unaudited): |
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