InMed Pharmaceuticals Inc. (IMLFF) Reports Second Quarter Fiscal 2019 Financial Results

 InMed Pharmaceuticals Inc. (“InMed” or the “Company”) (TSX:IN; OTCQX:IMLFF), a fully integrated, cannabinoid-based biopharmaceutical company that leverages its proprietary platform technologies to develop novel therapeutics for the treatment of diseases with high unmet medical needs, today reported financial results for the three and six months ended December 31, 2018, which is the Company’s second quarter of fiscal year 2019 (“2Q19”).

“During the second quarter of fiscal 2019, InMed made some significant advancements, specifically with our two scientific priorities of 2019,” stated President and Chief Executive Officer, Eric A. Adams.  “Regarding our INM-750 program for the treatment of Epidermolysis Bullosa (“EB”), we are nearing our final selection of the contract manufacturing organizations that will provide the process and analytical development and GMP production of the topical cream for our first-in-human trial; the final decision should be made by the end of this month.  Between now and early summer, we will also be working on the GMP supply of the active pharmaceutical ingredients to be used in the Phase I clinical trial.  During the balance of calendar 2019, we plan to initiate stability studies and other regulatory enabling studies, which will lead into Phase I trial.  We are still currently targeting a Clinical Trial Application (“CTA”) submission to Health Canada in the second half of calendar 2019, and the beginning of the Phase I trial by the end of calendar 2019.”

Mr. Adams continued, “In terms of our ongoing toxicology and pharmacology work with INM-750, we conducted two topical, 7-day dose range finding studies during 2Q19.  The studies evaluated skin irritation, plasma pharmacokinetics (“PK”), histology and skin/drug concentrations, whereby we demonstrated favorable results.  There were no drug-related adverse effects on the skin and we confirmed that the extent of systemic cannabinoid exposure was minimal after topical administration of the cream despite a dosing level 100-1,000-fold higher than what we anticipate the clinical dose to be.”

“During 2Q19, we engaged the contract research organization that will be performing our initial Phase I study in healthy volunteers, subject to, and under the auspices of the CTA, which will have two parts.  In the first cohort, we will evaluate the safety, tolerability, and PK of INM-750 cream in healthy volunteers with normal, intact skin; the volunteers will have cream applied once daily for 14 days.  In a second cohort of healthy volunteers, we will test the local safety and tolerability of applying INM-750 cream to small wounds once daily for seven days.  Both parts of the study will be conducted with two different drug concentrations.”

“During 2Q19, we also continued to make steady progress with regard to our biosynthesis platform technology,” commented Mr. Adams.  “We initiated the technology transfer activities from the University of British Columbia (“UBC”) to the National Research Council Canada (“NRC”) to support scale-up activities in late 2018.  The first part of this process is the transfer of the protocols for high-performance liquid chromatography which has recently been completed.  The second portion of tech transfer process relates to the transfer of the gene construct containing the coding sequence for the enzymes responsible for cannabinoid production.  We will initiate this portion of the tech transfer later this month.  After this second portion of the tech transfer is completed, we will initiate parameter optimization for fermentation scale-up activities at NRC.”