Single Ascending Dose Study. I guess we can call it the "SAD"...

Single Ascending Dose Study. I guess we can call it the "SAD" study

1) Gathering efficacy information in phase 1
Any chance ILA will gather early efficacy information in this study (to de-risk further studies)? ISLA-001's mechanism of action is to target "protection of the nucleus" [1], so I suppose this will be unlikely since phase 1 patients will be uninfected. There's not a lot of detail about of this protection works exactly.

@Davisite agree, for this reason this could have been a lead-in study, but I suppose it was more suitable for ILA team to create a separate rather than redesign the PEACH trial which scope is already under FDA review.

2) Raising additional funds
Having talked to David Foster shortly after the FDA rejection, I assume ILA intends to use the original IPO funds for phase 1 study and then possibly raise what's needed for the PEACH study. So, would not expect dilution to happen until PEACH approaching, i.e. not until 2024-2025.

3) Cost for the phase 1 study.
According to U.S. Department of Health and Human Services, in the anti-infective category, phase 1 is typically 30% of phase 2 [2]. We know $3,478,000 were raised by ILA specifically for the PEACH study [3], so suggests phase 1 could cost roughly $1.1m ($1.4 more realistic after inflation). Given the current market cap of $5.7m, that's roughly 25% dilution.

[1] https://hotcopper.com.au/threads/ann-prospectus.5999261/?post_id=52362845 (IPO prospectus page 25)
[2] https://aspe.hhs.gov/reports/examination-clinical-trial-costs-barriers-drug-development-0 (table 1)
[3] https://hotcopper.com.au/threads/ann-prospectus.5999261/?post_id=52362845 (IPO prospectus page 19)