InMed Pharmaceuticals, Inc. Q3 FY2020 earnings call

• Eric Adams highlighted progress in therapeutic development programs despite COVID-19, including milestones in INM-755's Phase 1 studies and preclinical work on INM-088's neuroprotection and delivery tech.
• Bruce Colwill reviewed financial results: Q3 R&D spend was ~$1.6M, G&A was ~$1M, net loss was $2.8M for the quarter, cash, cash equivalents, and short-term investments totaled $9.9M as of March 31, 2020, and the cash runway was extended to Q3 2021.
• The company's research activities were conducted virtually with minimal impact from remote work, and efforts were made to manage cash position and core programs despite COVID-19.

The company's therapeutic development programs include INM-755 for epidermolysis bullosa (EB) and INM-088 for glaucoma, as well as a biosynthesis program. For INM-755, the Phase 1 clinical program in healthy volunteers completed treatment, and the CTA for the second Phase 1 study was approved by Dutch authorities with a potential 2-month delay due to COVID-19. For INM-088, preclinical results showed neuroprotective effects, and work is ongoing on drug pharmacology studies and delivery technology selection. The biosynthesis program made progress with a collaboration with Almac, aiming for GMP batch readiness by the end of 2020. In terms of financials, R&D expenses for the third quarter were approximately $1.6 million, a decrease from the prior quarter, and G&A expenses were approximately $1 million.

• INM-755 milestones were pushed out by approximately 2 months due to COVID-19.
• INM-088 program was minimally impacted by COVID-19, but investigations into additional indications for drug candidates were de-prioritized.
• Cash resources were sufficient to fund planned operations until at least the third quarter of 2021, extending the cash runway.

• COVID-19 could cause delays in clinical trials, such as the potential 2-month delay in INM-755 trials.
• Recruitment challenges for EB clinical trials, which could limit the speed of progressing through trials.
• Uncertainty around the impact of a potential second wave of COVID-19 on trial timelines.

Q: When to expect filing for INM-755's NDA?

A: Eric Adams and Alexandra Mancini stated it's too early to project, as recruitment is a key variable in orphan disease trials.

Q: Data read-outs for INM-088 in vitro testing?

A: Results from the intact skin Phase 1 trial (101 trial) haven't been analyzed yet; the wounded skin trial hasn't started, with results expected in 2020.

Q: Utilization of biosynthesized product and delivery tech for INM-088?

A: Security of supply for CBN from external sources exists, and delivery tech selection for INM-088 is ongoing.

Q: R&D spend decrease and future ramp?

A: Bruce Colwill said R&D spend is likely flat, as heavy preclinical work for Phase 1 is behind, and focus is on ongoing studies.

Q: COVID-19 second wave impact on trials?

A: Efforts to resume trials quickly when the window opens, with topical therapy trial (INM-755 second Phase 1) viewed as low risk.

Q: Protocol design for INM-755 second Phase 1 trial?

A: Small trial with 8 subjects, evaluating wound healing using a topical cream, with 2 weeks of treatment and 1 week of follow-up.

Q: Technical roles in Almac collaboration?

A: Almac helps with process development, scale up, and proof-of-concept studies for the alternative manufacturing process.

Q: Concern about remaining listed on TSX?

A: Bruce Colwill stated there's no concern, as InMed is compliant with TSX continuous listing requirements.