Conference Transcript - RVPH 2026-09-29

Ben Shamsian, Other

Hello, everyone, and thank you all for joining us during the Lithium Partners Fall 2026 Investor Conference. My name is Ben Shamsi and Vice President, Lithium Partners, and today, Dr. Lachs Bhatt, CEO of Reviver Pharmaceuticals, will be taking us through a brief slide presentation, Reviver Trades Under Ticker RVPH. With that, let's get started. Dr. Bhatt, welcome, and I'll turn the floor over to you for your presentation.

Laxminarayan Bhat, CEO

Sure. Thanks, Ben. Thanks for having me here. I really appreciate this opportunity. So, hello, everyone. Before I start my presentation, I would like you all to view the forward-looking statements displayed here. So, in this presentation, I would like to give a brief overview of what we do here at Reviva. Many of you may be very familiar with our company, and then many of you, maybe first time, you know, hearing about our company. So a very high-level summary, mainly focused on the lead product, biliroxazine clinical data. At the end of the presentation, I would like to highlight upcoming milestones. They are near-term as well as long-term milestones so that you all can have what's the value proposition here and, you know, especially tied up around the upcoming milestones. So having said that, now coming to the business, what we do at Reviva, Reviva is a clinical stage, late stage pharmaceutical company focused on developing novel therapies for CNS primarily and also metabolic indications highlighted here. The lead product, biliroxazine, is the focus of today's presentation. Currently in the phase three development for schizophrenia, we have already completed multiple clinical trials, including first pivotal trial, successfully completed with a very good differentiated clinical product profile. So all the clinical data available to date, we believe that biliroxysme can be developed beyond schizophrenia to bipolar, major depressive disorder and ADHD in the psychiatric space. And then also the inflammatory conditions such as pulmonary arterial hypertension, pulmonary fibrosis and psoriasis. So today I will focus on schizophrenia program. So before I show some of the data, especially the phase three data and then differentiation profile, I would like to give a very high level summary of schizophrenia. Schizophrenia is not a single disease, rather it's a mix of major symptom domains, such as a positive symptom, negative symptom, mood and cognitive dysfunction as well as a you know some of the other conditions such as agitation and so on. In other words positive symptom, negative symptom you can call remaining put together as a functional deficits. So So despite having multiple treatments options available currently, around 30% patients do not respond to currently available treatment or partially respond to currently available treatment. We call them as refractory patients. And then also with available treatment options on treatment, high relapse episodes these patients get relapse back to acute symptoms. So that leads to often treatment discontinuation or switching the drug, one drug to another drug. As highlighted here, treatment discontinuation is very high in this patient population, around 30 to 70 percent in one year. Relapse is also very high, around 25 percent patients get relapse on treatment in one year and then 90 percent over the five years. So these are the very high-level significant unmet needs. Based on the data available, our drug biliroxazine addresses these unmet needs to a great extent, to our knowledge, much better than other treatment options available. So now coming to the mechanism of action, what makes our drug differentiated compared to other drugs? Schizophrenia is by and large caused by dysfunctional dopamine serotonin in the brain. So our drug addresses both dopamine and serotonin levels in the brain. In other words, it balances the dopamine serotonin level based on the mechanism of action. And then also it reduces inflammatory markers based in the large two clinical trials. So inflammatory markers are based on current clinical literature, play a critical role in schizophrenia, especially the patient's recovery as well as other related comorbidities. So addressing inflammation is very critical. Our drug has shown significant decrease in inflammatory markers in the pivotal trials. So I will highlight some of those in this presentation. So this is the phase three study, large phase three study. It has two parts. First part is a double-blind randomized trial global trial in 411 patients followed by open label study over one year to evaluate safety as well as a effectiveness of drug over one year period together it is around a 800 little over 800 patients were treated in this large trial It was a global trial. Around 60% patients came from US, rest from Asia and then Europe. So in other words, it's a true global trial. So this is the phase three primary endpoint where, as you can see, the primary endpoint positive and negative symptoms can reduce significantly from week one to week four. if you see statistically significant outcome started from week one to continue to improve with a sustained efficacy over a period of four years. And it is very well separated from placebo with a 10-point separation. So 10-point separation from placebo, to my knowledge, in four weeks, This is a really differentiated product, the highest reported for olanzapine in the reported pool of antipsychotics in four weeks is around eight point. Here, four or ten point separation makes this drug really a differentiated product. The low dose showed efficacy started in the second week and started improving at the end of four weeks, but it was not statistically significant. This is something expected. As you can see, there is a good dose response from low dose to high dose. So this is a very good outcome, very well differentiated, not only with the primary endpoint as well as multiple secondary endpoints. I will show you the data in the next slide. So this is the data shown here for the acute schizophrenia hospitalized patients for four weeks. The next slide here shows the data for the patients treated over a period of one year at their respective residence. In other words, in the outpatient trial at home, these patients received medication. It is a real-world experience. As you can see, we put three doses. In the hospitalized patients, we put two doses, low dose 15 milligrams, high dose 50. In this patient population, we put three doses, low dose 15, middle dose 30, and then highest dose 50 again. All three doses show really good efficacy. As you can see from the week first to 52 weeks over a period of 12 months, very consistent, sustained, durable efficacy over a period of one year. And then in over one year, from the double-blind hospitalized patients to completed one-year treatment, that is 13 months of treatment, we have seen, as you can see, the low tropolate points, around 46 to 50 point improvement from baseline. This is kind of a almost near recovery in this patient population. So this is really a good efficacy treatment effects, dose-dependent improvement in patients over a period of one year. So this is the summary of the data in the hospitalized patients, the first column, acute patients. In the next two columns are for in the one-year treatment, we split this one into six months and one-year completers. This is a very important criteria FDA requires and as well as a global regulatory agency is required to collect six months of data especially and one-year data. So requirement is 300 patients at least completed six months and then 100 patients completed one year. If you look at here, six months, we had 303 patients completed, six months treatment. And then 12 months, 100 patients required. Here, we have 159 patients completed. And then if you look at the magnitude of efficacy in the first line, total PAN score, it is a 10-point separation, continue to improve over a period of one year. The secondary endpoints, we evaluated eight different secondary endpoints. Again, the magnitude of efficacy from hospitalized patients to over a one-year period, you know, increased. Secondary endpoints are very critical in this treatment. They are reflective of, you know, effective for major symptom domains. And then they are also reflective of how the quality of life in these patients impact the secondary endpoint, in other words, improvement in secondary endpoint is a reflection of, you know, how these patients are on the path to recovery or complete recovery. And then lastly, the discontinuation rate, as you can see, in our case, 50% better than any other approved antipsychotics currently in the market, whether it is acute schizophrenia patients or in the long-term study. So the reported discontinuation rate is much lower compared to any other approved antipsychotics to date. And then lastly, the multiple biomarkers have been evaluated. They are both efficacy as well as safety biomarkers. In the interest of time, I would not go into detail, but they are in the right direction. The patients are on the path to full recovery. So in summary, just to highlight here, over one year period of treatment, the billar oxygen showed a robust efficacy, sustained durable efficacy over a period of one year. While the historical data shows around a, you know, 20 to 25% disc relapse, you have seen only less than 1%. Very well tolerated motor side effects are less than 1%. And then reported antipsychotics are, reported motor side effects for antipsychotics are over, you know, 5 to 10%, most antipsychotics here, we have seen less than 1%. And then metabolic side effects are, you know, reduced cholesterol, and there is no impact on blood sugar, only we have seen around a 1.2 to 1.5 kilo weight gain compared to placebo in the hospitalized patients. And then also over a period of one year, it did not increase weight gain. It's around a little over one kilo weight gain. That we believe not related to the treatment, rather related to the diet. That kind of fluctuation in weight, you can find in any normal, healthy persons in the diet change. So endocrine side effect, most antipsychotics cause side effects here. We do not see that one hormonal changes that noticeable in many drugs here. Hormonal dysfunction balanced and then continue to maintain over a period of one year. That's a remarkable property features what we have seen with this drug. The implications of that when there's a mitigation of sexual side effect, what we have seen with the most antipsychotics currently in the market, we don't have that problem. So around 60% of patients suffering from schizophrenia, other psychiatric illnesses suffer from sexual side effect. So this could be a benefit to most of those patients as well. And then there are no cardiac signals, in other words, serious adverse event reported in this patient population, or a GI side effect or constipation. Generally, we call it as constipation in this patient's very high. We don't see that one here. Lastly, drug-induced liver injury is also very high in this patient population. We don't see that one in this drug. Overall, very clean profile. Now, to summarize the comparative data here, if you compare our data with the most widely used antipsychotics on the right side, top five drugs in 2024, they capture over 90% of the global market. And then also if you compare other antipsychotics widely used around eight antipsychotics, our drugs clearly stands out differentiated with respect to overall efficacy. And then this is the drug, you know, it's there on our website, would not go into detail. Many of you may be familiar with Coplita. It's a drug that was approved for schizophrenia, bipolar, and major depressive disorder. In 2025, this company was, drug was acquired by J&J for $14.6 billion. If you look at that phase three data reported versus R-drug, R-drug certainly very well differentiated compared to, you know, primary endpoint or key secondary endpoints, as well as a safety overall, very well differentiated profile. Lastly, where do we stand here? We have completed, you know, most of the clinical trials required for NDA. only the second phase three study we need to complete for the NDA. So what we are currently doing, we would like to introduce a new proprietary drug product in the second phase three. So this new proprietary drug product based on the available data has improved bioavailability and then this has an extended patent life up to 2046. So with this new proprietary drug introduced in the second phase three, we not only can able to extend the patent life to 2046, that's a good feature if we have to extend this one for other additional indications beyond schizophrenia. So here is the, you know, this slide gives us a upcoming milestones in the short term as well as a long term over a period of three years. So we are a, we have currently, you know, submitted dossier to FDA to switch the drug product to a new improved version in the second trial. We are expecting FDA feedback in this quarter. And as soon as we have the FDA feedback, we would put the drug in the bioavailability study. This is called a bridge study. With this bridge study, you know, we can immediately after that, that will be in the Q1 event. We can quickly start the second phase three study that FDA has already reviewed and approved the protocol. We can start. It's a one-month dosing to complete the study. It takes about 14 months. We expect to have a, you know, top-line data completion of the study in mid-2028 and a NDA filing in end of 2028 or early Q1, 2029. That would allow us to, you know, we hope to get approval if everything goes well by end of 2029. And then again, the new patent for the improved product, we expect to have a patent granted sometime later this year or a Q1, 2027. We applied for accelerated approval of this patent. We intend to develop this drug beyond schizophrenia for other big psychiatric indication. Lastly, we are currently listed on OTCQB market in first half of next year, based on this multiple milestones expected. We anticipate uplisting the company tickle symbol RBPH on the NASDAQ stock market in first half of 2027. So I pause here. Thank you all for attending the company presentation. and happy to answer any questions you may have.

Ben Shamsian, Other

Okay, well, thank you, Dr. Bhatt. And thank you to everyone for watching. If you have any questions or would like to schedule a meeting with Reviva, please send me an email at shamcian at lithunpartners.com, S-H-A-M-S-I-A-N at lithunpartners.com. If you'd like to learn more about Lithuan Partners, please visit our website or follow us on LinkedIn and YouTube and stay connected about future events. We hope you enjoyed the rest of the conference and have a great day.

Laxminarayan Bhat, CEO

Thank you. Thank you all.