Hello, everyone, and thank you all for joining us during the Lytham Partners Spring 2026 Investor Conference. My name is Ben Shamsian, Vice President at Lytham Partners. Today, Dr. Lax Bhat, 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. Bhat, welcome. Now I'll turn the floor over to you for your presentation.
Ben, thank you for having me here. Really appreciate the opportunity to present here at Lytham Conference, and then looking forward to connecting the viewers and then investors in this conference. Before I begin my presentation, I would like all the viewers to take a look at our forward-looking statements displayed here. I'll give a very brief overview of what we do at Reviva and some exciting clinical data we recently disclosed. Most importantly, upcoming milestones I will highlight in the near term, in 2026, and then in the next 18 months. Here is our pipeline. We are a 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. Brilaroxazine is the most advanced molecule.
We have completed pivotal phase III study, one study in a large global trial in 411 patients. In all together, we treated close to 900 subjects. Based on the available data, we believe this is a very well-differentiated product for schizophrenia indication. Also based on the available data, this drug can be readily developed for additional indications highlighted here, large indications with huge unmet needs such as bipolar disorder, major depressive disorder, ADHD. Now quickly coming to the mechanism of action. Before that, would like to give a very high-level overview. What is schizophrenia? Schizophrenia is a debilitating mental disorder. Globally, around 24 million people suffer from schizophrenia. In U.S. alone, close to 4 million. 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. This clearly an indication that there is a huge unmet need. 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. 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, dopamine, there are some receptors they are implicated in certain schizophrenia domains, such as negative symptoms, primarily key serotonin receptors like 5-HT2B, 5-HT7, 5-HT2A. Dopamine D4 also implicated. Positive symptom primarily directed towards D2 activity. A balanced activity is critical for treating schizophrenia. 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. 5-HT2B 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 factor our drug brings on table. Overall, clinical data is very well differentiated. Now quickly walk through the data.
Prior to that, would like to outline the phase III trial design, and that's 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. Altogether, it is close to 800 patients. If you look at the data here, this is the pivotal phase III data double-blind study. Two doses put in the study. Top dose showed consistently in the phase II, 50 mg, as well as in the phase III, 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 ill patients, this is slightly suboptimal in some patients. 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. Both doses work 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, competitor endpoint is really a differentiated product. I have a comparative data to show you. Here is the summary of the double-blind data. The positive symptom, total PANSS score, 10-point separation with the effect size of 0.6, it is really a good outcome. There are multiple secondary endpoints evaluated in the study. They are highlighted here. Secondary endpoints are really predictor for overall outcome because secondary endpoints are more or less directed towards individual symptom domains. Schizophrenia is not a single disease, rather it is a cluster of symptom domains. 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. It is 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. Patients with a high level negative symptom, [disactivity or negative symptom component, our 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 mg, 30 mg and then 50 mg, showed good efficacy, sustained efficacy, progressive efficacy over a period of one year.
Here is the summary of data, primary endpoints, and all the key secondary endpoints, not only in the phase III, also, I put the data here for the phase II study. It was a large patient population, almost identical to phase III trial design, four weeks trial. All the top dose showed identical outcome in both the trial. If you look at the long-term trial data, again, magnitude further 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 the approved antipsychotics, what we have seen the data around 20%-25% patients get relapse on treatment. We don't see that one here.
This is really a good data. Now, coming to the safety, we do not see 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%-15% in the similar trial. Even in the long-term trial, we haven't seen motor side effect over 1%. Only side effects 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 1 kg increase, about 1 kg 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. This is the comparison of data with other widely used antipsychotics. As you can see, left-hand side, brexpiprazole, 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. This is the data comparison, phase III data compared to CAPLYTA. CAPLYTA is one of the antipsychotics currently in the market. It's also approved for bipolar and major depressive disorder. It was acquired by Johnson & Johnson last year, around $14.9 billion. We have compared to the historical data, qualitative comparison, our data is much superior to the CAPLYTA. Now where do we stand here?
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- 14 months to complete. We anticipate giving the top-line data in Q4 next year and filing NDA in early 2028. I pause here, if viewers have any questions, I am happy to answer. The major regulatory outcome is what we are anticipating. The trial data generated using the brilaroxazine salt. In the second study, we would like to switch the new form of brilaroxazine that would have extended patent life till 2046. We are currently reaching out to U.S. FDA for alignment of switching the drug to be in the second phase III study and progress towards NDA.
We are expecting FDA feedback sometime mid this year, and this is the major catalyst. Based on this, we will quickly start the second phase III study. I pause here. Happy to answer any questions you may have.
Thanks, Lax. Just a couple of quick ones. The second phase III trial, when can investors expect an NDA on brilaroxazine for schizophrenia, and what's been holding it back in recent months?
We are expecting regulatory outcome. The current drug product, what we are using, the composition of matter patent expires in 2030. Since it's a new chemical entity, we get extension till 2035. For a new drug around a post-approval, around six to seven years commercial exclusivity may be a bit short. That's what we got the feedback from a few major pharma companies and institutional investors. If we are able to extend the patent life, then that would be interesting with respect to value creation. We worked on this over the last one year, and then now we have already filed patent for a new form of brilaroxazine 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 III. That's what we are looking for FDA feedback in the next 8 to 12 weeks.
Okay.
We start the phase III study.
That's great. Thanks, Lax. 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@lythampartners.com. S-H-A-M-S-I-A-N at lythampartners.com. If you'd like to learn more about Lytham Partners, you can visit our website at lythampartners.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.
Thank you, Ben. Thank you.