Hello, everyone, and thank you all for joining us during the Lytham Partners Fall 2026 Investor Conference. My name is Ben Shamsian, I am Vice President, Lytham Partners. Today, Dr. Lax Bhat, CEO of Reviva Pharmaceuticals, will be taking us through a brief slide presentation. Reviva trades under ticker RVPH. With that, let us get started. Dr. Bhat, welcome, and I will turn the floor over to you for your presentation.
Sure. Thanks, Ben. Thanks for having me here.
Yeah.
Really appreciate this opportunity. Hello, everyone. Before I start my presentation, I would like you all to view the forward-looking statements displayed here. 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 many of you may be first time hearing about our company. A very high-level summary, mainly focused on the lead product, brilaroxazine, 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 is the value proposition here, and especially tied up around the upcoming milestones. With that, 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, brilaroxazine, is the focus of today's presentation. Currently in the phase III development for schizophrenia, we have already completed multiple clinical trials, including first pivotal trial, successfully completed with a very good differentiated clinical product profile. All the clinical data available to date, we believe that brilaroxazine can be developed beyond schizophrenia to bipolar, major depressive disorder, and ADHD in the psychiatric space, and also the inflammatory conditions such as pulmonary arterial hypertension, pulmonary fibrosis, and psoriasis. Today I will focus on schizophrenia program. Before I show some of the data, especially the phase III data and 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, say, positive symptom, negative symptom, mood, and cognitive dysfunction, as well as 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. Despite having multiple treatment 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. Also, with available treatment options on treatment, high relapse episodes, these patients get relapse back to acute symptoms. That lead 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%-70% in one year. Relapse is also very high.
Around 25% patients get relapse on treatment in one year, and then 90% over the five years. These are the very high-level significant unmet needs based on the data available. Our drug, brilaroxazine, addresses this unmet need to a great extent, to our knowledge, much better than other treatment options available. 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. 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. Also, it reduces inflammatory markers based in the large two clinical trials. 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.
Addressing inflammation is very critical. Our drug has shown significant decrease in inflammatory markers in the pivotal trials. I will highlight some of those in this presentation. This is the phase III study, large phase III 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 effectiveness of drug over one year period. Together, it is around a little over 800 patients were treated in this large trial. It was a global trial. Around 60% patients came from U.S., the rest from Asia and then Europe. In other words, it's a true global trial. This is the phase III top primary endpoint where as you can see, the primary endpoint positive and negative symptom scale reduced significantly from week 1 to week 4.
If you see statistically significant outcome started from week 1 to continue to improve with the sustained efficacy over a period of four years. It is very well separated from placebo with a 10-point separation. A 10-point separation from placebo, to my knowledge, in four weeks is a really differentiated product. The highest reported for olanzapine in the reported pool of antipsychotics in four weeks is around eight point. Here, for a 10-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. 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. 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 milligram, high dose 50. In this patient population, we put three doses, low dose 15, middle dose 30, and the 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.
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 two bullet points, around 46 to 50 point improvement from baseline. This is kind of almost near recover or a recovery in this patient population. This is really a good efficacy treatment effects, dose-dependent improvement in patients over a period of one year. This is the summary of the data in the hospitalized patients, the first column, acute patients. 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, as well as the global regulatory agencies require to collect six months of data especially, and one year data.
The requirement is 300 patients at least completed the 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, the 100 patients required. Here we have 159 patients completed. If you look at the magnitude of efficacy in the first line, total PANSS 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 increase. Secondary endpoints are very critical in this treatment. They are reflective of 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 how these patients are on the path to recovery of complete recovery. 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. The reported discontinuation rate is much lower compared to any other approved antipsychotics to date. Lastly, the multiple biomarkers have been evaluated. They are both the efficacy as well as the 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.
In summary, just to highlight here, over a period of one year of treatment, the brilaroxazine showed a robust efficacy, sustained durable efficacy over a period of one year. While the historical data shows around a 20%-25% relapse, here we have seen only less than 1%. Very well tolerated, motor side effects are less than 1%, and reported motor side effects for antipsychotics are over 5%-10%, most antipsychotics. Here, we have seen less than 1%. Metabolic side effects are reduced cholesterol, and there is no impact on blood sugar. Only we have seen around a 1.2-1.5 kilo weight gain compared to placebo in the hospitalized patients. Also over a period of one year, it did not increase weight gain. It is 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. 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 continue to maintain over a period of one year. That is a remarkable property features what we have seen with this drug. The implications of that then is a mitigation of sexual side effect, what we have seen with most antipsychotics currently in the market. We do not have that problem. Around 60% patients suffering from schizophrenia, other psychiatric illnesses suffer from sexual side effect. This could be a benefit to most of those patients as well. There is 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 is very high. We do not see that one here. Lastly, drug-induced liver disease also very high in this patient population. We do not 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. Also if you compare other antipsychotics widely used around eight antipsychotics, our drugs clearly stands out differentiated with respect to overall efficacy. This is the drug, it is there on our website, would not go into detail. Many of you may be familiar with CAPLYTA.
It is a drug that is approved for schizophrenia, bipolar, and major depressive disorder in 2025. This drug was acquired by J&J for $14.6 billion. If you look at that phase III data reported versus our drug, our drug certainly very well-differentiated compared to primary endpoint or key secondary endpoints, as well as the safety overall, very well-differentiated profile. Lastly, where do we stand here? We have completed most of the clinical trials required for NDA. Only the second phase III study we need to complete for the NDA. What we are currently doing, we would like to introduce a new proprietary drug product in the second phase III. This new proprietary drug product, based on the available data, has improved bioavailability, and this has extended patent life up to 2046.
With this new proprietary drug introduced in the second phase III, we not only can extend the patent life to 2046. That's a good feature if we had to extend this one for other additional indications beyond schizophrenia. This slide gives us upcoming milestones in the short-term as well as the long-term over a period of three years. We have currently 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. 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, immediately after that will be in the Q1 event, we can quickly start the second phase III study that FDA has already reviewed and approved the protocol.
We can start. It's a one month dosing. To complete this study, it takes about 14 months. We expect to have top-line data completion of the study in the mid-2028, and an NDA filing in end of 2028 or early Q1 2029. That would allow us to, we hope to get approval if everything goes well, by end of 2029. Then again, the new patent for the improved product, we expect to have a patent granted sometime later this year or 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 up-listing the company, ticker symbol RVPH, on the Nasdaq stock market in first half of 2027. I pause here.
Thank you all for attending the company presentation. Happy to answer any questions you may have.
Okay. Well, thank you, Dr. Bhat, 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 shamsian@lythampartners.com, S-H-A-M-S-I-A-N@lythampartners.com. If you'd like to learn more about Lytham Partners, please visit our website or follow us on LinkedIn and YouTube, and stay connected about future events. We hope you enjoy the rest of the conference, and have a great day.
Thank you. Thank you all.