INM-755 getting closer to the clinic InMed recently reported results for FY19 and is on track for INM-755 for epidermolysis bullosa (EB) to be in the clinic by the end of 2019. The Phase I programme will consist of two trials, one in healthy volunteers with intact skin and the other in healthy volunteers with small wounds. A Phase I/II trial in EB patients is expected to begin in Q121. In glaucoma, the company has switched its lead candidate to INM-088, which has some specific advantages to the former lead, INM-085. Advanced preclinical and formulation development is expected to begin by the end of the year.
Entering the clinic by the end of the year
InMed is on track for initiating the Phase I programme for INM-755 in healthy volunteers by the end of 2019. There will be two separate trials that will be carried out serially as data from the trial in subjects with normal, intact skin are necessary for the trial in subjects with small wounds. We expect the Phase I programme to be complete in Q320 with the critical Phase I/II in EB patients starting in Q121.
Glaucoma coming into view
The glaucoma programme is advancing with a new lead candidate due to superior preclinical results. Advanced preclinical and formulation development is expected to begin by the end of the year with key IND-enabling studies expected to begin in H120 after discussions with regulators.
Biosynthesis progressing
The company’s E. coli-based biosynthesis process continues to move forward. The company has optimised several fermentation parameters that are part of the Up Stream Process (USP) to maximise yield and initiated Down Stream Purification (DSP). InMed is also investigating an alternative process (the exact nature of which is undisclosed) that may have advantages in terms of cost and yield, and will decide which approach to move forward with in H120.
Valuation: C$256m or C$1.48 per basic share
We have slightly adjusted our valuation from C$255m or C$1.48 per basic share (C$1.14 per diluted share) to C$256m or C$1.48 per basic share (C$1.22 per diluted share). The valuation increase of rolling forward our NPV was offset by pushing back our expectations for initial revenues from the biosynthesis business to FY22 from FY21 and lower net cash. InMed had C$18.0m in cash at 30 June and we believe this provides a runway into FY21. We now forecast the company will raise C$20m over the next two years to fund operations.