The following is excerpted from the question-and-answer section of the transcript.
(Questions from industry analysts are provided in full, but answers are omitted - download the transcript to see the full question-and-answer session)
Question: Mayank Mamtani - B. Riley Securities, Inc. - Analyst
: Fantastic. Thanks for that overview and definitely a lot to look forward to this year and the next.
Maybe just focusing then on your lead candidate, 3107, working through the inflammation cascade in what you guys termed as type 3 diabetes
in terms of the impact it has in neurons in the brain, how about we get into the science a little bit there? So maybe we also talk about the background
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APRIL 28, 2022 / 5:30PM, BIVI.OQ - BioVie Inc at B Riley Neuro & Ophthalmology Conference (Virtual)
of this molecule. I believe it's been tested in cardiometabolic conditions before. And just -- also would love to know what other efforts you've had
in the past on the neuroscience side of things that are applicable to the Alzheimer's program that you're running.
Question: Mayank Mamtani - B. Riley Securities, Inc. - Analyst
: And maybe it's a great, I think, point to kind of bring in Joe also who recently joined the organization as I understand and have looked at things
externally also. I'm sure he did diligence on the program and the history, but he has probably also looked at some of the emerging literature that
has come about.
So why don't you, Joe, talk about this concept of peripheral inflammation, metabolic syndrome, and sort of its implication becoming increasingly
clear in Alzheimer's with some of the work that's going on in the industry?
Question: Mayank Mamtani - B. Riley Securities, Inc. - Analyst
: Yeah, I do want to get into your clinical studies -- the Phase 2 and the Phase 3. But just maybe rounding up the mechanism here, just maybe talk
about this importance of intracellular targeting. Obviously, it's great to have the downstream sort of impact we are trying to have on [neural]
damage. But one can argue maybe extracellular versus intracellular, so how confident you feel -- and, Cuong, you can also chime in -- in terms of
the target and the way you're sort of going after it with a small molecule.
Question: Mayank Mamtani - B. Riley Securities, Inc. - Analyst
: And maybe also talk about this new paper. I think in Nature paper that recently came out on the impact of NF-kappa B on tau tangles. Again, I think
not just you are learning about your own drug. I think [the industry] is also learning about this pathway, and it's just entanglement with the more
established pathologies. So just maybe touch on that, and then we can get into the studies.
Question: Mayank Mamtani - B. Riley Securities, Inc. - Analyst
: Yeah. So maybe let's talk about how you are trying to evaluate all this target engagement work and imaging, obviously, by a number of biomarkers
in Alzheimer's obviously in the works. So talk a little bit about your Phase 2 study, what we have already built in, and then also your Phase 3 study
design.
Question: Mayank Mamtani - B. Riley Securities, Inc. - Analyst
: Okay. And just maybe highlight like what -- the 25 subjects -- for how long are they treated? And which of these markers should relatively move
more and what has an impact on cognition, if you may? If there is a -- I also think about your ongoing Phase 3 study which is adaptive design. So
how -- what you might learn from here will inform your confidence and then the protocol amendments in making Phase 3.
Question: Mayank Mamtani - B. Riley Securities, Inc. - Analyst
: Got it.
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APRIL 28, 2022 / 5:30PM, BIVI.OQ - BioVie Inc at B Riley Neuro & Ophthalmology Conference (Virtual)
Question: Mayank Mamtani - B. Riley Securities, Inc. - Analyst
: And implications to Phase 3, if you can? Same patient population -- is that mild to moderate?
Question: Mayank Mamtani - B. Riley Securities, Inc. - Analyst
: There is a question, why not include a cognition endpoint here? Is it just through a smaller study?
Question: Mayank Mamtani - B. Riley Securities, Inc. - Analyst
: Of course. Got it. Got it.
Question: Mayank Mamtani - B. Riley Securities, Inc. - Analyst
: Yeah. And then yeah, maybe just touch on how your Phase 3 design sort of works towards a regulatory path, because it will require another Phase
3 study, I'm assuming. And maybe, as you mentioned this impact of COVID -- but these mild-to-moderate studies have lately been a little difficult
to enroll. So just highlight maybe some of the pragmatic considerations you -- and learnings, obviously, you've had that you're trying to apply to
how you execute this study, but also the next study.
Question: Mayank Mamtani - B. Riley Securities, Inc. - Analyst
: Got it.
Question: Mayank Mamtani - B. Riley Securities, Inc. - Analyst
: Yeah. I mean, it's -- but also, it looks like you also have another Phase 2 Parkinson's study. It's a drug-drug interactions -- I think there was a component
of that. And yeah, just maybe talk about your preclinical data. I think you had some interesting non-human primate data there also. And yeah, just
help us understand how that program will progress this year.
Question: Mayank Mamtani - B. Riley Securities, Inc. - Analyst
: Yeah. And just maybe to clarify, how many patients or treatment duration this Parkinson's study? And is it L-dopa plus your drug versus L-dopa
and then kind of show of motor symptom impact? Is that kind of what we are talking about?
Question: Mayank Mamtani - B. Riley Securities, Inc. - Analyst
: Okay, great.
Question: Mayank Mamtani - B. Riley Securities, Inc. - Analyst
: Fantastic. And maybe just running up against time here, talk about your balance sheet and maybe just summarize the breadth of pipeline of the
CDR neuroscience, what catalysts we should look out for in the next 12 to 18 months.
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APRIL 28, 2022 / 5:30PM, BIVI.OQ - BioVie Inc at B Riley Neuro & Ophthalmology Conference (Virtual)
Question: Mayank Mamtani - B. Riley Securities, Inc. - Analyst
: Okay, great. Thanks so much for, again, participating in the conference. Appreciate the audience tuning in and look forward to following your
progress, Cuong and Joe.
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