Replies to post #383137 on Innovation Pharmaceuticals Inc (IPIX)

[olden_grumpini]

This information was included in the IPIX 10-K for the period ended June 30, 2021. You can claim it was "buried", but SEC filings are required reading for investors.

From the 10-K

IBD, Ulcerative Colitis (UC) — Brilacidin is also being developed as a treatment in more extensive forms of IBD.

Development of a delayed release oral formulation has been in progress, with development work expanding into immediate release formulations due to unexpected findings encountered. Such findings appear due to the inherent physiochemical properties of the compound, and those of polymers used to achieve delayed release. An immediate release, multi-particulate capsule formulation has been developed and a ‘research and development’ batch has progressed to stability testing at the manufacturing vendor. Further work is ongoing, in preparation for manufacture of clinical trial supplies.

Based on these recent findings, the development plan for ulcerative colitis has been adapted with inclusion of Phase 1 testing of the immediate release oral formulation. Clinical trials will be able to progress pending completion of clinical trial supply manufacturing (currently scheduled for January 2022) and securing sufficient working capital.

I am not in any way diminishing the fact that this is bad news.

[loanranger]

I'm not going to try to sell you on this because it's probably unlikely, but "Unexpected findings encountered" doesn't necessarily mean that they were BAD findings.

It's not out of the question that what they learned suggested that the immediate release version would be an improvement some how.
That said, leaving "unexpected findings" unexplained is hardly ever good.

[MinnieM]

I disagree. Brilacidin phase III in Oral Mucositis (OM) is further ahead than IBD, Ulcerative Colitis (UC). OM is likely our best chance to move forward in a timely manner if the covid trial doesn't meet endpoints. I have no idea why the decision was made to reformulate UC, but, it's not the only hope to move forward.

You may have missed that the UC reformulation decision had been listed in the 10K filed on 9.27.21 pg 12 https://www.sec.gov/Archives/edgar/data/1355250/000147793221006717/ipix_10k.htm

IBD, Ulcerative Colitis (UC) — Brilacidin is also being developed as a treatment in more extensive forms of IBD.

Development of a delayed release oral formulation has been in progress, with development work expanding into immediate release formulations due to unexpected findings encountered. Such findings appear due to the inherent physiochemical properties of the compound, and those of polymers used to achieve delayed release. An immediate release, multi-particulate capsule formulation has been developed and a ‘research and development’ batch has progressed to stability testing at the manufacturing vendor. Further work is ongoing, in preparation for manufacture of clinical trial supplies.

Drug has already been ordered for a phase III OM trial which appears to be targeted for first part of 2022.

From 10K filed 9.27.21 pg 36 https://www.sec.gov/Archives/edgar/data/1355250/000147793221006717/ipix_10k.htm

We have ordered Brilacidin API (active pharmaceutical ingredient) for delivery in January 2022, for use in our planned oral mucositis Phase 3 clinical study. There is no assurance the order will be manufactured or received timely. We have encountered prior delays and cost overruns in ordering the production of Brilacidin API.

From company website you can see that Brilacidin OM is furthest along and in line with the 10K filing info above. http://www.ipharminc.com/stages-of-development



From 10Q filed 11.9.21 pg 28 you can also see Brilacidin OM is further along than Brilacidin UC. https://www.sec.gov/ix?doc=/Archives/edgar/data/1355250/000147793221007937/ipix_10q.htm
















Message in reply to: BOLDED
Is anyone paying attn??? This is a CRITICAL find from the 10Q. The time and cash spent working on the long release B for UC- you all remember that, right?-may not be working out. All that chatter and effort with the delivery system and the drug availability-out the window? Buried in a 10 Q?

It will not be the end of the world if B beats C- and the data are conclusive.

HOWEVER, folks, this was the best hope for this company until 18 months ago when the moonshot for COVID took over.

UC was the last best chance for IP.

And now we are told that the delaYED RELEase tanked???
"Unexpected findings encountered"????

That is all we are told.

This is a big big problem for the company. It means there nay be nothing left to see here if the trial data fail.