Kelt, here is my stab at connecting the dots:
As Dr. Bertolino points out in the 9/20/18 PR the 2 top priorities were first to move B-OM forward with FDA and other (Europe?) regulatory authorities and secondly to analyze Prurisol 2b results. I take this to mean that IPIX had the funds at that point which means that the P 2b CRO has been paid and results could be reported at any time. Dr. B goes on to say that WHEN additional funding (3 weeks later MFO deal gets signed) work will commence on new product formulations for 1) Oral Pill for Kevetrin-OC and 2) Oral Pill for B-IBD. I believe that the B-IBD funding for oral pill development and a follow on Phase 3 B-IBD trial will be paid for by the Term sheet partner once it is inked as well as the B-SOM phase 3 trial. I also believe IPIX will bring a “plus one” partner to the End of Phase 2 B-OM meeting with the FDA which may have already happened. IPIX has only tapped into $2.2M of the $10M MFO deal and the remaining MFO funds will not be needed once the Term Sheet deal gets finalized.
We could see several significant Press Releases in the next month including:
- BTD for B-OM (Application under FDA review as of 9/20/18 PR. 60 days will be by 11/20/18)
- Prurisol phase 2b final results
- Big Pharma royalty deal for B-OM and B-IBD (Finalize Term Sheet deal)
- IBD Innovate Conference on 11/13/18
In Q1 we could see the following:
- Start of Phase 3 for B-SOM (note the S for severe as in high dosage chemo patients)
- Prurisol Big Pharma Term Sheet and possibly a finalized deal
- FDA Kevetrin IV to pill bridge study
- Start of Phase 3 B-IBD funded by our new Big Pharma Brilacidin partner
- Start of Phase 2? B-Atopic Dermatitis and Acne- note that if IPIX’s new partner pays for B-SOM and B-IBD then Leo’s comment in the 10/9/18 announcement below might be where IPIX direct their Brilacidin funding going forward. Also note that Dermatitis is not included in the Term Sheet deal and could be licensed out in a separate royalty deal.
- Possibly a start to B-ABSSI phase 3 study if the B-OM/B-IBD upfront dollars are over $50M
====================================================================
10/22/18 The Company is in the process of selecting a Contract Research Organization to complete the necessary remaining bridging toxicology work toward developing Kevetrin in oral form, which remains the top priority within Innovation Pharmaceutical’s cancer program.
10/9/18 “This new financing serves to further bolster our balance sheet and gives us flexibility in working to meet our near-term goals, which includes advancing Brilacidin into a pivotal study,” Leo Ehrlich
9/24/18 “For now, we want to maintain our focus on the shortest path to commercialization, which we believe is best achieved by targeting treatment in the more aggressive chemotherapy regimens, in which cases of severe oral mucositis abound.” Leo Ehrlich
9/20/18 “Our clinical assets are both highly promising and well-diversified,” said Arthur P. Bertolino, MD, PhD, MBA, President and Chief Medical Officer at Innovation Pharmaceuticals. “Near-term strategic clinical priorities remain: to work closely with the FDA and other regulatory authorities to align on the remaining development plan necessary for Brilacidin in Oral Mucositis; to analyze the Prurisol Phase 2b data in Psoriasis; and, as additional funding becomes available, to commence work on new product formulations—1) an oral pill for Kevetrin in Ovarian Cancer; 2) an oral pill for Brilacidin in IBD; and a topical application for Brilacidin in Atopic Dermatitis and Acne.”
In coming weeks, the Company plans to submit a request for an End-of-Phase 2 meeting with the Food and Drug Administration (FDA) to discuss appropriate next steps in the development of Brilacidin for the treatment of Oral Mucositis (OM), which has already been granted Fast Track designation. A Breakthrough Therapy Designation application is currently under review with the FDA.
As Dr. Bertolino points out in the 9/20/18 PR the 2 top priorities were first to move B-OM forward with FDA and other (Europe?) regulatory authorities and secondly to analyze Prurisol 2b results. I take this to mean that IPIX had the funds at that point which means that the P 2b CRO has been paid and results could be reported at any time. Dr. B goes on to say that WHEN additional funding (3 weeks later MFO deal gets signed) work will commence on new product formulations for 1) Oral Pill for Kevetrin-OC and 2) Oral Pill for B-IBD. I believe that the B-IBD funding for oral pill development and a follow on Phase 3 B-IBD trial will be paid for by the Term sheet partner once it is inked as well as the B-SOM phase 3 trial. I also believe IPIX will bring a “plus one” partner to the End of Phase 2 B-OM meeting with the FDA which may have already happened. IPIX has only tapped into $2.2M of the $10M MFO deal and the remaining MFO funds will not be needed once the Term Sheet deal gets finalized.
We could see several significant Press Releases in the next month including:
- BTD for B-OM (Application under FDA review as of 9/20/18 PR. 60 days will be by 11/20/18)
- Prurisol phase 2b final results
- Big Pharma royalty deal for B-OM and B-IBD (Finalize Term Sheet deal)
- IBD Innovate Conference on 11/13/18
In Q1 we could see the following:
- Start of Phase 3 for B-SOM (note the S for severe as in high dosage chemo patients)
- Prurisol Big Pharma Term Sheet and possibly a finalized deal
- FDA Kevetrin IV to pill bridge study
- Start of Phase 3 B-IBD funded by our new Big Pharma Brilacidin partner
- Start of Phase 2? B-Atopic Dermatitis and Acne- note that if IPIX’s new partner pays for B-SOM and B-IBD then Leo’s comment in the 10/9/18 announcement below might be where IPIX direct their Brilacidin funding going forward. Also note that Dermatitis is not included in the Term Sheet deal and could be licensed out in a separate royalty deal.
- Possibly a start to B-ABSSI phase 3 study if the B-OM/B-IBD upfront dollars are over $50M
====================================================================
10/22/18 The Company is in the process of selecting a Contract Research Organization to complete the necessary remaining bridging toxicology work toward developing Kevetrin in oral form, which remains the top priority within Innovation Pharmaceutical’s cancer program.
10/9/18 “This new financing serves to further bolster our balance sheet and gives us flexibility in working to meet our near-term goals, which includes advancing Brilacidin into a pivotal study,” Leo Ehrlich
9/24/18 “For now, we want to maintain our focus on the shortest path to commercialization, which we believe is best achieved by targeting treatment in the more aggressive chemotherapy regimens, in which cases of severe oral mucositis abound.” Leo Ehrlich
9/20/18 “Our clinical assets are both highly promising and well-diversified,” said Arthur P. Bertolino, MD, PhD, MBA, President and Chief Medical Officer at Innovation Pharmaceuticals. “Near-term strategic clinical priorities remain: to work closely with the FDA and other regulatory authorities to align on the remaining development plan necessary for Brilacidin in Oral Mucositis; to analyze the Prurisol Phase 2b data in Psoriasis; and, as additional funding becomes available, to commence work on new product formulations—1) an oral pill for Kevetrin in Ovarian Cancer; 2) an oral pill for Brilacidin in IBD; and a topical application for Brilacidin in Atopic Dermatitis and Acne.”
In coming weeks, the Company plans to submit a request for an End-of-Phase 2 meeting with the Food and Drug Administration (FDA) to discuss appropriate next steps in the development of Brilacidin for the treatment of Oral Mucositis (OM), which has already been granted Fast Track designation. A Breakthrough Therapy Designation application is currently under review with the FDA.
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