Today’s PR spells out IPIX’s near term priorities very clearly. Statements from the PR are in quotations and my comments are parenthesis:
“held constructive meetings covering the next stages of the Company’s pipeline development, aiming for advancement of Brilacidin in Inflammatory Bowel Disease (IBD), including Ulcerative Colitis (UC) and Crohn’s Disease (CD).”
(Note that the above IBD indications of Colitis and Crohn’s are referred to in last Thursday’s Term Sheet PR as “Right of First Refusal for rights to Brilacidin for the treatment of more extensive forms of Inflammatory Bowel Disease,” and NOT included as part of the baseline Term Sheet deal meaning the above indications would bring in additional funds above and beyond the initial Term Sheet agreement.)
“As the Company works towards finalizing a definitive agreement with respect to Brilacidin for Ulcerative Proctitis (UP)/Ulcerative Proctosigmoiditis (UPS),”
(Appears that the Term Sheet is very close to being finalized with Up Front Non-Dilutive Cash. The above instances are the baseline indications for the Term Sheet.)
“management is aligning to address additional IBD markets where it believes there are large market opportunities for Brilacidin to potentially become a leading therapeutic”
(IBD market of $48B by 2022 and IPIX is targeting multiple instances within this huge market.)
“with expectations that a drug formulation company may be contracted in the coming weeks to begin this work.”
(Term sheet turns into contract = cash= drug formulation in coming weeks as in very soon.)
“Careful selection of an appropriate drug formulation partner should prove invaluable in expeditiously moving Brilacidin forward for diseases like UC and CD, disorders that remain in need of safe and effective options for millions of patients,”
(In case there was any doubt that Dr. Bertolino has detailed science advancement plans once IPIX gets a cash infusion. The word “expeditiously” makes it clear that there will be multiple Brilacidin projects simultaneously taking place very soon.)
“Our aim is to develop a safe competitor with a novel mechanism of action in an oral formulation of Brilacidin with the anticipation that it may achieve similar results to the retention enema version that proved effective in our Phase 2 proof-of-concept study of Brilacidin for UP/UPS. Development of an appropriate oral formulation of Brilacidin will position us to move into clinical testing soon thereafter.”
(Multiple instances prove that Brilacidin is a franchise drug and will create multiple revenue streams for IPIX.)
“A Phase 2 trial of Brilacidin as an oral rinse for the prevention of Severe Oral Mucositis (SOM) in patients with Head and Neck Cancer, met its primary and secondary endpoints, including reducing the incidence of SOM. The Company plans to advance Brilacidin oral rinse into Phase 3 development, subject to available financial resources”
(Note this PR may signal that IPIX is now describing B-OM as Brilacidin Oral Rinse for SOM. (For sake of simplicity I will still refer to it as B-OM until my hunch is confirmed.) The above quotation was in the “About Innovation Pharmaceuticals” section and not in the main PR. B-OM stands on its own and is independent of the IBD Term Sheet. The B-OM Phase 3 will be the first phase 3 initiated by IPIX but it is probable that IPIX will have multiple Brilacidin studies happening simultaneously. IPIX may have multiple funding deals being negotiated and finalized. The Term Sheet for IBD may provide a large enough cash infusion that it could fund multiple trials for both B-IBD and B-OM. ALL OF THESE POTENTIAL SENARIOS ARE VERY POSSITIVE FOR SHAREHOLDERS!)
“held constructive meetings covering the next stages of the Company’s pipeline development, aiming for advancement of Brilacidin in Inflammatory Bowel Disease (IBD), including Ulcerative Colitis (UC) and Crohn’s Disease (CD).”
(Note that the above IBD indications of Colitis and Crohn’s are referred to in last Thursday’s Term Sheet PR as “Right of First Refusal for rights to Brilacidin for the treatment of more extensive forms of Inflammatory Bowel Disease,” and NOT included as part of the baseline Term Sheet deal meaning the above indications would bring in additional funds above and beyond the initial Term Sheet agreement.)
“As the Company works towards finalizing a definitive agreement with respect to Brilacidin for Ulcerative Proctitis (UP)/Ulcerative Proctosigmoiditis (UPS),”
(Appears that the Term Sheet is very close to being finalized with Up Front Non-Dilutive Cash. The above instances are the baseline indications for the Term Sheet.)
“management is aligning to address additional IBD markets where it believes there are large market opportunities for Brilacidin to potentially become a leading therapeutic”
(IBD market of $48B by 2022 and IPIX is targeting multiple instances within this huge market.)
“with expectations that a drug formulation company may be contracted in the coming weeks to begin this work.”
(Term sheet turns into contract = cash= drug formulation in coming weeks as in very soon.)
“Careful selection of an appropriate drug formulation partner should prove invaluable in expeditiously moving Brilacidin forward for diseases like UC and CD, disorders that remain in need of safe and effective options for millions of patients,”
(In case there was any doubt that Dr. Bertolino has detailed science advancement plans once IPIX gets a cash infusion. The word “expeditiously” makes it clear that there will be multiple Brilacidin projects simultaneously taking place very soon.)
“Our aim is to develop a safe competitor with a novel mechanism of action in an oral formulation of Brilacidin with the anticipation that it may achieve similar results to the retention enema version that proved effective in our Phase 2 proof-of-concept study of Brilacidin for UP/UPS. Development of an appropriate oral formulation of Brilacidin will position us to move into clinical testing soon thereafter.”
(Multiple instances prove that Brilacidin is a franchise drug and will create multiple revenue streams for IPIX.)
“A Phase 2 trial of Brilacidin as an oral rinse for the prevention of Severe Oral Mucositis (SOM) in patients with Head and Neck Cancer, met its primary and secondary endpoints, including reducing the incidence of SOM. The Company plans to advance Brilacidin oral rinse into Phase 3 development, subject to available financial resources”
(Note this PR may signal that IPIX is now describing B-OM as Brilacidin Oral Rinse for SOM. (For sake of simplicity I will still refer to it as B-OM until my hunch is confirmed.) The above quotation was in the “About Innovation Pharmaceuticals” section and not in the main PR. B-OM stands on its own and is independent of the IBD Term Sheet. The B-OM Phase 3 will be the first phase 3 initiated by IPIX but it is probable that IPIX will have multiple Brilacidin studies happening simultaneously. IPIX may have multiple funding deals being negotiated and finalized. The Term Sheet for IBD may provide a large enough cash infusion that it could fund multiple trials for both B-IBD and B-OM. ALL OF THESE POTENTIAL SENARIOS ARE VERY POSSITIVE FOR SHAREHOLDERS!)
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