There was actually quite a bit packed into a small press release. So, analyzing yesterday's PR:
The first paragraph was the meat of the PR. Some dismissed it as just one more developing IND submission in a string of them, most of which still remain unfunded. There are barely sufficient funds to tale Brilacidin-ABSSSI to market if the FDA decides they want 2 Phase 3 trials ahead of the NDA submission. So, what gives with all these pending trials. Well, thank about it. The CEO and company are looking to license or sell the IP, which is not just B-ABSSSI but also a hundred other possible indications for the entire mimetic platform.
There is now formally submitted data to the FDA for 6 different indications, data that includes very convincing preclinical PK/PD and efficacy arguing that the newer defensin mimetics will perform equally well as Brilacidin has against ABSSSI. All 6 are unmet need category and this last one, Hidradentitis Suppurativa is an orphan drug. Orphan drug designation upon approval for market qualifies the sponsor company for a valuable priority review voucher. Gilead paid $125 million for a PRV last year. All of this adds to the value of a license or purchase of the IP. My claculations for Brilacidin-ABSSSI alone is worth at least $750 million in upfront and benchmark payments plus a double-digit royalty. There are now 6 indications in the development pipe all advanced to PIND, IND and Phase 2/3 clinicals, and each ranging in value from about $300 million to $750 million.
Then there is the second paragraph, a very dense paragraph information wise. Kevetrin p21 data release is what everyone zeroed in on so I won't say any more about that. But:
"Latest information on the Cellceutix pipleline"--6 defensin mimetic indications in development, Prurisol Phase 2 trial, Brilacidin-OM phase 2 trial, Brilacidin ABSSSI trial, and how many more drug approaching PIND in development?
"Additions to the Board of Directors" and "uplisting to NASDAQ exchange"--The BoD is the last step to NASDAQ. Additions clearly states that the new BoD are already in place. Folks, we are uplisting no later than the end of the Fiscal year on June 30.
Very soon, possibly even before the end of June, there should be a deal in place. The possibilities are now a license for just Brilacidin ABSSSI (>$40 million upfront and $700 million in benchmarks), but I don't think so. More likely, if a license, it will be the entire platform (>$80 million upfront and >$2 billion in benchmarks plus >15% royalty). Another possibility is a buyout based on optimal proven valuation plus intangibles. In this case, $15-$18 billion would be the starting bid. The final deal might be as high as >$30 billion. Kevetrin alone is proving to be worth at least $10 billion and probably >$15 billion. And, that's if it requires combination therapy rather than a stand alone for several types of cancer.
These aren't just tea leaf readings; these are data driven assessments.
WTF?
AI
