Mining Sector Ideas

[gfp927z]

Bigworld, Here's some additional info from the Acurx conference call. Luci said that the durability and microbiome data from the Phase 2b will be released as the company gets it in the weeks and months ahead (see below), rather than all at once at the end. Here is his approx timeline for the news flow -

Dec ------------ Sustained Clinical Cure data
Dec or Jan --- Extended Clinical Cure data up to 94 days
Jan or Feb --- Impact on Microbiome data
March --------- End of Phase 2 meeting with FDA

On the partnership / M+A front, Luci said they have some NDAs (plural). As I understand it, an NDA is a Non-Disclosure Agreement, which (I think) allows sharing of non-public info like clinical data between Acurx and interested pharmas.

Luci has clearly said (in July) that he favors an M+A or partnering deal prior to the Phase 3s, and from the conf call it sounds like this process will advance in 2024 as the additional data becomes available. So a lot will probably depend upon the strength of the upcoming durability and microbiome data, the number of interested pharmas, etc.

With the Phase 3s, they will need two, and Luci said they are favoring (if possible) a smaller first Phase 3 trial, and then a larger second Phase 3. The first Phase 3 would be approx 200 patients (133 getting Ibez and 66 getting Vanc), and would likely cost in the $20-25 mil range, and will include some international sites, and will be a non-inferiority trial. He said the advantage of a smaller first Phase 3 is that it would be cheaper and faster, and should provide more than enough data to get an M+A or pharma deal (assuming good data of course). Ideally though, Luci said (in July) that he prefers doing a deal prior to Phase 3.

On the funding / cash side, he said they now have $9 mil range, and up to $15 mil potentially coming from the exercising of warrants. Luci says he wants to proceed - 'as non-dilutively as is humanly possible'.

Concerning the Pasteur Act, he said that he isn't expecting anything happening soon (is awaiting Congressional approval) since the government is currently in such disarray.

Anyway, this info is from my notes, so you may want to verify by listening to the conference call -

877-660-6853, and conf call code is - 13742354



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