BioVie Inc at Cantor Fitzgerald Global Healthcare Conference Transcript

The following is excerpted from the question-and-answer section of the transcript.

Question: Charles Duncan - Cantor Fitzgerald, L.P. - Analyst : Let's start off with a softball. And these are soft, and often -- softballs are often not so soft. And that is when you think about neurodegenerative diseases. And let's talk about Alzheimer's specifically. What has happened, and what do you think will happen for the therapeutic landscape in the near term? Cuong, why don't you start?

Question: Charles Duncan - Cantor Fitzgerald, L.P. - Analyst : No, I -- great perspective there. Mark?

Question: Charles Duncan - Cantor Fitzgerald, L.P. - Analyst : I remember covering stocks as a younger -- much younger analyst and having coverage in immune-modulating companies, including one that's somewhat famous called Dendreon. And I would go to ASCO, and I've been walking up the hall to the immune-modulating session, and everyone else would be walking the other way. And they would be like, where are you going, Charles? What am I doing, right? And it turned out to be true. It was the case that those early observations eventually resulted in a transformation of the industry, frankly. And I agree with you. I think that we're on the precipice of seeing that happen. Cuong mentioned a 30% reduction in the progression of cognitive decline, but that kind of overplays that. That's after 18 months of antibody therapy that requires fairly frequent injections and is not free, not only in terms of financial cost but not free in terms of safety. But it certainly is a step forward, so help us understand why you believe there's an opportunity to move beyond that step forward.

Question: Charles Duncan - Cantor Fitzgerald, L.P. - Analyst : So you make an interesting observation that the drug started its life in diabetes, and some people have suggested that Alzheimer's is the diabetes of the brain, right? And I guess that makes some sense, but I'm wondering if Mark can add to the concept that inflammation is a key driver of continued progression of neurodegenerative diseases. Mark? REFINITIV STREETEVENTS | www.refinitiv.com | Contact Us consent of Refinitiv. 'Refinitiv' and the Refinitiv logo are registered trademarks of Refinitiv and its affiliated companies. SEPTEMBER 26, 2023 / 2:30PM, BIVI.OQ - BioVie Inc at Cantor Fitzgerald Global Healthcare Conference

Question: Charles Duncan - Cantor Fitzgerald, L.P. - Analyst : Yes, we are going to go into the mechanism. Why don't we go into the mechanism of an HGF modulator? (Multiple speakers) Fosgonimeton, let's first get this.

Question: Charles Duncan - Cantor Fitzgerald, L.P. - Analyst : Interesting.

Question: Charles Duncan - Cantor Fitzgerald, L.P. - Analyst : But sticking with mechanism and bringing in the concept of inflammation because inflammation causes the pathology often of these things and where you need a repair mechanism. How is that? How is that connection made? REFINITIV STREETEVENTS | www.refinitiv.com | Contact Us consent of Refinitiv. 'Refinitiv' and the Refinitiv logo are registered trademarks of Refinitiv and its affiliated companies. SEPTEMBER 26, 2023 / 2:30PM, BIVI.OQ - BioVie Inc at Cantor Fitzgerald Global Healthcare Conference

Question: Charles Duncan - Cantor Fitzgerald, L.P. - Analyst : Very good.

Question: Charles Duncan - Cantor Fitzgerald, L.P. - Analyst : Interesting. I wonder if that plays a role in the observation Mark made with the mice and rats and neuron life. So we heard earlier in a panel about little bit more of an earlier species of A-beta, which are referred to as the oligomers. Not the monomers, but the oligomers, which will result in the in the plaque formation and accumulation. And that ultimately is the key biomarker for keeping track of whether or not a person has Alzheimer's or may have Alzheimer's, may get Alzheimer's; and then secondly, whether or not there's clinical benefit, obviously measuring clinical outcomes as well. But Mark, if you could help us understand how modulating HGF/MET with fosgonimeton can actually play a role in that cascade of plaque formation. REFINITIV STREETEVENTS | www.refinitiv.com | Contact Us consent of Refinitiv. 'Refinitiv' and the Refinitiv logo are registered trademarks of Refinitiv and its affiliated companies. SEPTEMBER 26, 2023 / 2:30PM, BIVI.OQ - BioVie Inc at Cantor Fitzgerald Global Healthcare Conference

Question: Charles Duncan - Cantor Fitzgerald, L.P. - Analyst : We'll get into that.

Question: Charles Duncan - Cantor Fitzgerald, L.P. - Analyst : Okay. And in both cases, you have an interesting differentiation of the paradigm relative to how and when the efficacy of monoclonal antibodies is measured, which is generally 18 months. Maybe you see biomarker changes at six months that have predictive value, but really, you need to go out 18 months to see that kind of clinical benefit. However, you two have drugs that are very different, not monoclonal antibodies. In one case, certainly oral; in another case, maybe future oral that may work quickly in six months. Help us understand that therapeutic paradigm and why six months could be useful to a patient, six-month clinical benefit?

Question: Charles Duncan - Cantor Fitzgerald, L.P. - Analyst : So we'll get into the clinical trials in detail. But before do, just conceptually, why is six months useful? Mark? REFINITIV STREETEVENTS | www.refinitiv.com | Contact Us consent of Refinitiv. 'Refinitiv' and the Refinitiv logo are registered trademarks of Refinitiv and its affiliated companies. SEPTEMBER 26, 2023 / 2:30PM, BIVI.OQ - BioVie Inc at Cantor Fitzgerald Global Healthcare Conference

Question: Charles Duncan - Cantor Fitzgerald, L.P. - Analyst : But it seems like the mechanism and perhaps amenable to creating value in even earlier-stage patients as well.

Question: Charles Duncan - Cantor Fitzgerald, L.P. - Analyst : So it sounds like perhaps your clinical strategy is, first of all, a signal to noise and as well unmet need. Why don't we get into some of the clinical development? So we'll reverse order. For fosgonimeton, you have an ongoing Phase 2, LIFT-AD, very interesting study. If you could provide us a little perspective what that is?

Question: Charles Duncan - Cantor Fitzgerald, L.P. - Analyst : Okay. You made an interesting observation in that trial with regard to your past results from ACT-AD in that the drug seems to work better in patients who are not taking the current standard of care, cholinesterase inhibitors. Can you expound on that?

Question: Charles Duncan - Cantor Fitzgerald, L.P. - Analyst : Interesting. And the agency likes that? It's okay with that? I thought most Alzheimer's patients take Aricept. REFINITIV STREETEVENTS | www.refinitiv.com | Contact Us consent of Refinitiv. 'Refinitiv' and the Refinitiv logo are registered trademarks of Refinitiv and its affiliated companies. SEPTEMBER 26, 2023 / 2:30PM, BIVI.OQ - BioVie Inc at Cantor Fitzgerald Global Healthcare Conference

Question: Charles Duncan - Cantor Fitzgerald, L.P. - Analyst : Okay, interesting. So there is huge need, and people don't necessarily want to take or do take Aricept over time. So my perception is wrong that that is an impediment should you show activity or efficacy to actual adoption.

Question: Charles Duncan - Cantor Fitzgerald, L.P. - Analyst : Sure.

Question: Charles Duncan - Cantor Fitzgerald, L.P. - Analyst : And you mentioned the slippery slope of MMSE 19. What does that mean to people -- for people in the audience? We're talking about that starts to accelerate progression in about a year.

Question: Charles Duncan - Cantor Fitzgerald, L.P. - Analyst : You become agitated. You become perhaps [a burden].

Question: Charles Duncan - Cantor Fitzgerald, L.P. - Analyst : Yes. Okay, so interesting. When is LIFT going to read out? REFINITIV STREETEVENTS | www.refinitiv.com | Contact Us consent of Refinitiv. 'Refinitiv' and the Refinitiv logo are registered trademarks of Refinitiv and its affiliated companies. SEPTEMBER 26, 2023 / 2:30PM, BIVI.OQ - BioVie Inc at Cantor Fitzgerald Global Healthcare Conference

Question: Charles Duncan - Cantor Fitzgerald, L.P. - Analyst : How do you know you're enrolling Alzheimer's patients?

Question: Charles Duncan - Cantor Fitzgerald, L.P. - Analyst : Not vascular dementia?

Question: Charles Duncan - Cantor Fitzgerald, L.P. - Analyst : Okay. But it doesn't depend necessarily on imaging of plaque?

Question: Charles Duncan - Cantor Fitzgerald, L.P. - Analyst : Good. Okay. Makes sense. Any questions on Athira at this point? Because I was going to move over to BioVie. BioVie, very interesting time. Thank you for coming at this time because you're about to read a Phase 3, right?

Question: Charles Duncan - Cantor Fitzgerald, L.P. - Analyst : Help us understand 3107 and the Phase 3 that you're conducting because like Mark's team, you are also conducting a mild to moderate, which is a little bit later stage than where the where the monoclonal antibodies have shown activity. REFINITIV STREETEVENTS | www.refinitiv.com | Contact Us consent of Refinitiv. 'Refinitiv' and the Refinitiv logo are registered trademarks of Refinitiv and its affiliated companies. SEPTEMBER 26, 2023 / 2:30PM, BIVI.OQ - BioVie Inc at Cantor Fitzgerald Global Healthcare Conference

Question: Charles Duncan - Cantor Fitzgerald, L.P. - Analyst : Yes, congrats.

Question: Charles Duncan - Cantor Fitzgerald, L.P. - Analyst : So you alluded to this. I'd like to say that every good clinical experiment has three possible outcomes, either it works or it doesn't work or it works maybe, right? And the works maybe, it sounds like that could be an interesting result as well for you. And in fact, it could be used to inform the next step. Now the next step, as I understand it, is a study in a little bit earlier patient population. Can you tell us about that?

Question: Charles Duncan - Cantor Fitzgerald, L.P. - Analyst : I'm a scientist. Back off, man. I'm a scientist. It worked, maybe. Go do it again.

Question: Charles Duncan - Cantor Fitzgerald, L.P. - Analyst : I see. So no imaging required?

Question: Charles Duncan - Cantor Fitzgerald, L.P. - Analyst : Okay.

Question: Charles Duncan - Cantor Fitzgerald, L.P. - Analyst : So I want to ask a question about something you just said, but perhaps we'll open it up to a broader question, which is if we are sitting here in a year, what will you be most proud of having achieved? What will you look forward to talking to? And perhaps I'll start with you, Cuong. Because you just said starting an MCI study and then reading out next year, which is a pretty aggressive timeline. You think you can get that done?

Question: Charles Duncan - Cantor Fitzgerald, L.P. - Analyst : Okay, okay. So I imagine that it will be a proud moment if you can read that out. I think that will be number one. REFINITIV STREETEVENTS | www.refinitiv.com | Contact Us consent of Refinitiv. 'Refinitiv' and the Refinitiv logo are registered trademarks of Refinitiv and its affiliated companies. SEPTEMBER 26, 2023 / 2:30PM, BIVI.OQ - BioVie Inc at Cantor Fitzgerald Global Healthcare Conference

Question: Charles Duncan - Cantor Fitzgerald, L.P. - Analyst : So going back to the every good -- or going back to the works, maybe every good experiment suggests to others. So I'm just looking for clear interpretable data. Mark, tell us the next year. What is top of mind for you and Athira?

Question: Charles Duncan - Cantor Fitzgerald, L.P. - Analyst : Well, I'm hoping to be talking to you folks again in a year as well. And I appreciate your time today, and I appreciate the audience interest. So thank you very much. Have a great day.