Eric A. Adams, InMed's President and Chief Executive Officer, commented, "The third quarter of fiscal year 2019 was all about execution: the team is firing on all cylinders, R&D milestones are being accomplished, and we remain enthusiastic about our scientific advancements. Further, our financial position remains strong and we are confident that our existing cash runway positions us to complete our forthcoming significant milestones – specifically to advance our INM-755 program for the treatment of epidermolysis bullosa ("EB") through the completion of Phase I healthy volunteer studies, to advance our biosynthesis program in preliminary commercial scale-up activities, and to advance the glaucoma program through several pre-clinical studies."
"During the third quarter," Mr. Adams continued, "we transitioned our EB program to a single cannabinoid formulation, which is now referred to as INM-755. This was an important decision for the program, as we believe a single molecule product, instead of a combination product, will improve our overall probability of success, both in terms of clinical development as well as from a regulatory standpoint. In terms of our preparation for our Phase I study, we have finalized our selection of the service provider for our final sterile cream production."
"With regard to our proprietary biosynthesis platform technology," Mr. Adams continued, "we completed a number of important milestones and made meaningful advancements on several others:
- Completed the tech transfer from our collaboration partners at the University of British Columbia ("UBC") to the National Research Council Canada ("NRC") by successfully converting precursors into a specific cannabinoid using the appropriate DNA plasmid construct in E. coli.
- Initiated downstream process ("DSP") activities involving purification of cannabinoids from the fermented material at a GMP-ready contract development and manufacturing operation (CDMO).
- Published the first in a series of pending patent applications directed to the Company's biosynthesis platform technology for the manufacturing of pharmaceutical-grade cannabinoids. The first of which, entitled 'METABOLIC ENGINEERING OF E. COLI FOR THE BIOSYNTHESIS OF CANNABINOID PRODUCTS', addresses the enablement and maximization of cannabinoid production through optimization of the precursor substrates needed to support specific cannabinoid synthesis. This application and two more recently filed U.S. provisional patent applications cover various elements required to enable functional cannabinoid synthase production in an E. coli system."
Mr. Adams continued, "In the near term, we expect to complete the fermentation optimization initiative, to complete the process development of the DSP and to scale-up fermentation batches towards commercial scale. Finally, we will continue to pursue various avenues to maximize the yields and to lower the costs of cannabinoid manufacturing."
Results of Operations (expressed in Canadian Dollars):
- For 3Q19, the Company recorded a comprehensive net loss of $3.5 million, or $0.02 per share, compared with a comprehensive net loss of $2.1 million, or $0.01 per share, for the three months ended March 31, 2018 ("3Q18").
- Research and development expenses were $1.6 million for 3Q19, compared with $0.6 million for 3Q18. The increase in research and development expenses in 3Q19 as compared to 3Q18 was primarily due to: (a) increased spending on research supplies for the purchase of active pharmaceutical ingredients to be used in the clinical trial for INM-755; (b) increased spending on external contractors for work associated with preclinical studies for INM-755 required for the regulatory application to initiate clinical trials for INM-755 in the second half of calendar year 2019; (c) increased spending on the Company's biosynthesis program; and (d) increased R&D personnel compensation as a result of increased R&D staffing.
- The Company incurred general and administrative expenses of $1.0 million for 3Q19, compared with $0.8 million for 3Q18. The increase in general and administrative expenses in 3Q19 as compared to 3Q18 was primarily due to increased personnel compensation that reflects increased staffing, reflective of the growth in the Company's operations.
- At March 31, 2019, the Company's cash, cash equivalents and short-term investments were $20.4 million, which compares to $23.0 million at December 31, 2018.
- At March 31, 2019, the Company's total issued and outstanding shares were 172,133,633. Including outstanding stock options and warrants, as at March 31, 2019, the Company had 222,648,790 shares on a diluted basis. During 3Q19, the weighted average number of common shares was 171,328,077, which is used for the calculation of loss per share.