Conference Transcript - RVPH 2026-05-28

Ben Shamsian, Other

Hello, everyone, and thank you all for joining us during the Lithium Partners Spring 2026 Investor Conference. My name is Ben Shamsian, Vice President at Lithium Partners, and today, Dr. Lachs Bhatt, CEO of Reviva Pharmaceuticals, will be taking us through a brief slide presentation, Reviva Trades Under RVPH on the OTC. Let's get started. Dr. Bhatt, welcome, and now I'll turn the floor over to you for your presentation.

Laxminarayan Bhat, CEO

Ben, thank you for having me here. I really appreciate the opportunity to present here at lithium conference and then looking forward to connecting the viewers and then investors in this conference so before i begin my presentation i would like all the viewers to take a look at our forward-looking statements displayed here so i'll give a very brief overview of what we do at Reviva and some exciting clinical data recently you know disclosed and then most importantly upcoming milestones I will highlight in the near term in 2026 and then in the next 18 months. So here is our pipeline. We are a company late stage pharmaceutical company, a clinical stage pharmaceutical company focused on developing novel therapies for CNS indications, as well as immune disorders, as you can see here. We have two molecules in development. Brilleroxazine is the most advanced molecule. we have completed pivotal phase three study one study in the last global trial in 411 patients and then all together we treated close to 900 subjects and based on the available data we believe this is a very well differentiated product for schizophrenia indication and then also based on the available data this drug can be readily developed for additional indications highlighted here large indications with huge and mechanics such as bipolar disorder major depressive disorder adhd so now quickly coming to the mechanism of action before that would like to we give a very high level overview what is schizophrenia schizophrenia is a debilitating mental disorder globally around 24 million people suffer from schizophrenia in the U.S. alone, close to 4 million. And then despite having multiple treatment options, there is a significant unmet need. Around 30% patients either do not respond to currently available treatment or partially respond. Those who are responding to currently available treatment, the historical data what we are learning, so around 25% patients get relapse of symptoms, acute symptoms in one year treatment, 90% in over five years. So this is clearly an indication that there is a huge unmet need. So we believe with our data, our drug is very well differentiated to a great extent these unmet needs are addressed with our drug. Now coming to the mechanism of action, what causes schizophrenia? Dopamine serotonin imbalance in the brain primarily implicated for causing schizophrenia. So having said that, any new treatment developed for schizophrenia should be able to balance dopamine serotonin neurotransmitters in the brain. Of course, there are other neurotransmitters also imbalanced to my knowledge they are secondary the primary are serotonin and dopamine again when we say serotonin and dopamine there are sub receptors they are implicated in you know certain schizophrenia domains such as negative symptoms primarily key serotonin receptors like 5hd2b7 2a and then dopamine d4 also implicated and then positive symptom primarily directed towards D2 activity. A balanced activity is critical for treating schizophrenia. And then most importantly, what we are learning in the recent literature, inflammation is a major component of schizophrenia. If a drug is able to address inflammation, that could be a very well differentiated treatment. Phi HD2B is one of the receptors implicated as a main mediator of inflammatory cascades. Our drug has most potent activity for this. This is one of the differentiating factors our drug brings on table. Overall, clinical data is very well differentiated. Now, quickly walk through the data. Prior to that, I would like to outline the phase three trial design and as a long-term safety study they are shown here part one is an efficacy study large study for a pivotal study and then part two is a long-term safety study all together it is close to 800 patients now if you look at the data here this is the pivotal phase three data double band study two doses put in the study top dose showed consistently in the phase two 50 milligram as well as in the phase three, good efficacy, even in the long-term safety, and then efficacy is also very well maintained. The low dose showed good efficacy in stable schizophrenia patients. For acutely patients, say this is a slightly suboptimal in some patients. However, However, majority patients, this is still a good drug. As you can see, it takes about a week more to start showing a treatment effect compared to top dose. However, both doses worked very well in the long-term treatment. Overall, this is a very well-differentiated product with a 10-point separation from placebo. To my knowledge, 10-point is a really differentiated product. but I have a comparative data to show you. So here is the summary of the data, double bind data. The positive symptom, total PAN score, 10 point separation with the effect size of 0.6. It's really a good outcome. There are multiple secondary endpoints evaluated in the study. They are highlighted here. Secondary endpoints are really predicted for overall outcome because secondary endpoints are more or less directed towards individual symptom domains as schizophrenia is not a single disease rather it is a cluster of symptom domains so these eight secondary endpoints by and large address the total schizophrenia spectrum that's what we often say this is a broad spectrum antipsychotic drug and then it is a the most critical component negative symptom it's a major unmet need in the currently treatment options are addressed very well as you can see you know patients with a high level negative negative symptom this activity or negative symptom component are drug has shown really robust efficacy this is further confirmed by vocal biomarker. This is an objective biomarker. Besides this biomarker, we have put several blood-based biomarkers. They are highlighted here, including inflammatory markers. They are all in the right direction. This is the data for one-year treatment. As you can see here, all three doses, 15, 30, and then 50, showed good efficacy, sustained efficacy, progressive efficacy over a period of one year and then here is the summary of a you know data primary end points and all the key secondary end points not only in the phase three also i put the data here for the phase two study it was a large patient population almost identical to phase three trial design, four weeks trial, you know, all the top dose showed identical outcome in both the trial. If you look at the long-term trial data, again, magnitude further, you know, increased, and then trend is same. This is a very consistent data in over 800 patients. To summarize the data, it's very well tolerated from acute schizophrenia through one-year treatment with hardly any patients got relapsed in over one-year treatment. That is a very good outcome. As I mentioned at the beginning, with approved antipsychotics, what we have seen the data, around 20 to 25% patients get relapsed on treatment. We don't see that one here. This is really a good data. Now, coming to the safety, we do not see, you know, any major side effects here. All the side effects, like motor side effects, they are less than 1%, rather approved antipsychotics are known to have anywhere between the 4% to 15% in the similar trial. Even in the long-term trial, we haven't seen motor side effect over 1%. So, only side effects I have seen, we have seen here slightly increased weight gain, that too, it is very benign compared to most of the approved drugs currently. Again, this is not dose dependent, this is around a one kilo increase, about one kilo increase over a period of one year, and then in the one month over a period compared to placebo. Other than that, we do not see any major side effects here, especially cardiac side effects are very clean. There is no liver drug-induced liver injuries or no hormonal imbalance. These are all good attributes. So this is the comparison of data with other widely used antipsychotics, as you can see left hand side. Biloroxazine, our drug certainly in overall outcome shows robust efficacy. If you look at the other top five drugs currently in the market, our drug certainly showed much better data compared to top five antipsychotics currently in the market so this is the data comparison phase three data compared to cup lighter cup lighter is one of the antipsychotics currently in the market is also approved for by polar and media depressive disorder it was acquired by johnson and johnson last year around 14.9 billion dollar we have uh you know compared to the historical data or qualitative comparison our data is much superior to the cup light. So now where do we stand here? Now if you look at the data here all the studies clinical data we completed only the second confirmatory studies we are anticipating starting this one in the Q3 later this year. It takes about 12 to 14 months to complete. We anticipate giving the top line data in Q4 next year, and then filing NDA in early 2028. So I pause here, and then, you know, viewers have any questions, happy to answer. So major, you know, regulatory outcome, what we are anticipating. So the trial data generated using the biliroxazine salt in the second study, we would like to switch the new form of biliroxazine that would have extended patent life till 2046. So, we are currently, you know, reaching out to US FDA for alignment of switching the drug to in the second phase three study and then progress towards NDA. So, we are expecting FDA feedback sometime mid this year and this is the major catalyst and then based on this, you know, we will quickly start the second phase three study. So, I pause here. Happy to answer any questions you may have. Thanks, Lex.

Ben Shamsian, Other

Just a couple of quick ones. The phase three, the second phase three trial, when can investors expect an NDA on proxazine for scucifrenia?

Laxminarayan Bhat, CEO

And it's, you know what's what's been holding it back in recent months so you know the we are a expecting regulatory outcome the current drug product what we are using the compositions of matter patent expires in 2030 since it's a new chemical entity we get extension till 2035 so for a new drug around a post-approval around six to seven years commercial exclusivity may may be a bit short that's what we got the feedback from you know a few major pharma companies and any institutional investors so if we are able to extend the patent life then that would be an interesting with respect to value creation so we worked on this over the last one year and then now we have already filed patent for a new form of bilaroxazine that would have a commercial exclusivity till 2046. This is not something new in the industry. There are a few drugs similarly developed and extended patent life and commercial exclusivity. We also done the similar exercise. It requires FDA alignment to switch the drug in the phase three. That's what we are looking for FDA feedback in the next, you know, eight to 12 weeks. And then we start the phase three study.

Ben Shamsian, Other

That's great. Thanks, Lex. Looks like we are out of time here. Thanks everyone for watching. If you have any questions or would like to set up a meeting with Reviva, please send me an email at shamsian at lithonpartners.com, S-H-A-M-S-I-A-N at lithonpartners.com. If you'd like to learn more about Lithon Partners, you can visit our website at lithonpartners.com or follow us on LinkedIn to stay connected about future events. We hope you all enjoy the rest of the conference and have a great day.

Speaker 5

Thank you, Ben. Thank you all.