Where's the money coming from? Let me describe the situation. Then we'll talk money.
A large pharma is paying to see what xB3 can do in non-human primates. It's all about GABA-a, right? Riiiiiight...! That study should be done in 6 or 8 weeks. Whatever happens with GABA-a and the xB3 payload will pretty much predict what will happen with xB3-001 and brain tumour cells. It's not about BABA-a. That's just a side benefit.
The FDA uses the cancer tumour model to describe how surrogate endpoints are used for them to determine fast track approval. The FDA website indicates that drugs can be approved for use in humans, meaning approved for commercial release, at any point in the clinical trial process that the FDA sees fit, including after Phase 2. The FDA also says in their policy statements that the FDA can and sometimes does INVITE companies to apply for fast track consideration.
Within a month of getting the FDA response to its pre-IND submission, Bioasis states in its quarterly report that it will be applying for fast track consideration for xB3-001 after Phase 1. Coincidence? Huh?
The company has delayed the delivery of toxicology materials until the end of the agreement with the company that's doing the NHP study. Development for delivery of xB3-001 toxicology material is implicitly scheduled to restart in late December or in January. Money must be expected or such a prediction would be impossible. These things, along with austerity measures like delayed salaries, reduction of IR services, options as salary, and other things, are stretching the money out.
Take a look at xB3-001. It has a new full patent. That, by itself, extends its commercial exclusivity by a few years. Fast track approval of xB3-001 could possibly remove the cost of a Phase 3 clinical trial from the picture, possibly saving tens, perhaps hundreds of millions in clinical trial costs. More importantly, by eliminating the time it takes to do a Phase 3 trial, fast track approval would add a couple of years of early multi-billion dollar revenue to the picture.
Herceptin is a long-proven blockbuster drug. Pharmas know that. The FDA knows that. And Bioasis knows it. If this GABA-a study shows that xB3 doesn't change the payload's performance, then xB3-001 will start to look like it may not only replace Herceptin but may do it in a completely commercially exclusive way by treating brain tumours and the periphery, and in the process, eliminating competition from Herceptin and its biosimilars.
And some of you can worry for a moment that somebody doesn't have an interest in all that, in xB3-001?
Another thing has happened that too many people are too negative to even notice. Bioasis stated last fall and into the spring that it could essentially advance only one program, xB3-001. The January 2019 Corporate Presentation mentions xB3-007 but did not reveal anything about it - neurodegeneration was all it stated. That was our stated pipeline.
Since then, the Corporate Presentation and the roadshows have been populated with xB3-001, xB3-002 (Avastin, Glioblastoma), xB3-003 (Dox, Glioma), xB3-004 (anti-IL1RA, neuropathic pain), xB3-007 (Cerezyme, Gaucher Disease) and xB3-008 (I2S, MPS II, Hunter Syndrome, an LSD). All of these are xB3 constructs using already-approved drugs. That means they all have the potential to acquire fast track approval, they have blockbuster or near-blockbuster potential, and they are all new chemical entities with exclusive IP protections. If you want to think these things are now in the development pipeline for promotional reasons, then that's your business. I can tell you only this - they were all put there for business reasons, and they all represent real possibilities. If we're talking to eight companies, as Tailwinds says, then it would be hard to imagine our pipeline not being a part of those discussions. Where will those go after the GABA-a study shows that xB3 can deliever a payload, intact and ready to work in the brain. It's gonna make our pipeline look pretty damn good.
And you know what, neither the smart guy, the looker-upper extraordinaire, digitel, nor anybody else, has noticed the connection between cerezyme and Parkinson's disease. Do a Google search for cerezyme and Parkinson's and you might come to the hypothesis that Parkinson's might be the real target here, not Gaucher. It's just as legitimate to speculate about something positive as it is something negative.
So, about where the money's coming from. Maybe it's one or several of these:
- No money, go bankrupt or sell ourselves off for nothing.
- Conserve money for the next two or three months. (Postpone salaries, services, et.)
- Make arrangements with folks like WuXi, who knows all about the GABA-a study, knows the pharma, is also working on xB3-001 and knows the meaning and potential of it all.
- Do a licensing deal that brings in a mil or two or three. Tailwinds states there are eight. It takes just one.
- Do a small equity financing. Not a hint of that, not that I have I detected.
- Do a large equity financing with a fund or a pharma, lose control of the company and watch somebody else take over and benefit from xB3.
- Reliance upon friends and lovers.(Little bridge loans, free coffee, and such.)
- A little bit of reliance on some or several of these things, as the song says, to get you through the night.
And then there's this. Maybe, just maybe, somebody, maybe the GABA-a pharma, is so interested in xB3-001 that there's no way they'll let anything happen to Bioasis that could put that opportunity in jeopardy. That pharma is paying up to $4 million to do the GABA-a study. Please tell me why they gave us $500,000 last December. That's in addition to the almost $4million for the study. Did they need to do that? What would another hundie or three mean to such a large company for such an opportunity as xB3-001 represents. (As in, don't worry, Bioasis, we'll pay your bills. You can invoice us later.)
I have never worried about the money. Over the years I have worried about greed and avarice. I have worried about incompetence, inexperience, wrong decisions and intellectual laziness. I do not worry about money when we have something so potentially valuable as the xB3 platform.
This post contains forward-looking statements, observations and predictions that may or may not be accurate or come to pass. But know this, this is exactly as I intended to post. It's how I'm thinking about this and I mean everything I posted.
And digitel is a fool. Go back and review his posts of the last few days. He actually went out and searched for an article that tried to say that FDA fast track approval may have no value. Man, that is the epitome of being purposefully negative.
Because I refuse to end a post with the word "negative," let me say that it's time to start being positive. We have every reason to be immensely positive.
jdstox