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Message: Quarterly filings 10/30/17

Bioasis quarterly filings 10/30/17 are available on SEDAR. It sounds like Mark Day and company have and continue to thoroughly evaluate the past work of Bioasis in order to identify the most promising programs (i.e. xB3-001, xB3-002, xB3-003) to advance to non-human primates for 3D whole brain imaging/target engagement studies. H1 2018 should be exciting fo the advancement of these three internal programs. These imaging studies should move quick once started. I also look forward to hearing more in Q1 2018 about the clinical manufacturing of the xB3-001 drug for the Phase 0 studies. Hopefully the finished product will be ready for Phase 0 study by mid-2018, if not earlier, as the June 2017 news release indicated. As for the LSD studies....it is great to hear that IND-enabling studies with an expert CRO will be done and that they still intend to advance their internal LSD program. It's unfortunate that the IND-enabling Scarpa/Padova collaboration had to be terminated because of their slow pace. But going with the CRO is a good choice to expedite and complete these studies.

"We are currently evaluating all research and development (R&D) projects and expect to conclude this review later in 2017. The results of this review will be disclosed to shareholders in greater detail no later than the next quarterly filing."

"One key change to the previous strategy is that we will utilize 3D whole brain imaging to assess target engagement and pharmacodynamics biomarkers (e.g., glucose utilization, neurochemical changes, etc.) to increase the probability of selecting the optimal doses for all of our therapeutic candidates. This, in turn, is a cost-effective way to select assets with the best probability of success in the clinic.

1. xB3–001: Brain Metastasis: Clinical manufacturing will begin in preparation for clinical studies (Q1).

2. xB3–002: Glioblastoma: Preclinical studies will commence in Q2/3 utilizing 3D whole brain imaging Target engagement studies and Pharmacodynamic Markers (e.g. glucose metabolism).

3. xB3–003: Parkinson’s Diseases (GBA1 mutations): Preclinical studies will commence in Q1/2 utilizing 3D whole brain imaging target engagement studies and pharmacodynamic markers in non‐human primate Parkinson’ Disease model.

4. Continue to advance our LSD program, which is being conducted by an expert CRO with 30 years of proven experience in IND‐enabling studies. More news to follow by 2Q 2018."

Of course there are other things we are still waiting to hear about that weren't addressed in the quarterly filings. For example, the June 2017 news release stated "Our plan is to utilize non-invasive, non-human primate (NHP) brain imaging to assess eight targets (across oncology, rare diseases and neurological indications) for their ability to get to the needed site of action in the brain." We've heard about xB3-001, xB3-002 and xB3-003 but not the other targets. Understandably, they want to focus first on the most promising internal programs, but I anxiously await hearing about the other planned targets.

We are also still awaiting an update on the company's licensing model, as the June 2017 news release indicated "In a future message, I will similarly discuss the company’s licensing model." But it sounds like from the MD&A, that many companies wanted to see more internal evaluation and validation studies: "Given the lack of human clinical data, most pharmaceutical companies require internal evaluation and validation studies. Coupled with the global failures so far of several blood-brain barrier delivery systems the companies are cautious, slowing the adoption time and making clear to us the necessity for Bioasis-directed human clinical trials." The completion of the non-human primate imaging/target engagement studies should go a long way to address some of these concerns.

Then of course, the money question. "The Company will continue to need to raise funds for its future operations and for its pre-clinical programs potentially leading to the filing of one or a number of Investigational New Drugs (INDs)." What kind of financing will they do? How much dilution, if any, will be required? How much money do they need to raise?

We stay tuned for more details. In the meantime, I'm re-assured that BiOasis is on course.

BearDownAZ

 

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