Small & MidCaps im Fokus: RedHill Biopharma Ltd. // Neue Corona-Medikamente in der Pipeline

Thank you. Thank you very much for having me.

Thank you for the question. This is a very big milestone for us. Opaganib, for your listeners who may not be familiar with this drug, is the drug that we're formulating to try to treat severe COVID-19 infection. It's an oral novel pill with a dual mechanism of action, both antiviral and anti-inflammatory. That gives us several advantages. First, as a different mechanism of action from other drugs studied or approved, we will try to work on both the cause and the effect of the disease. Second, we potentially can overcome viral mutations. Third, because it's an oral pill, there's an advantage in terms of getting the drug easily distributed and also in as wide a context as possible. So we've been working around the clock to complete the study. This is a global study enrolling 475 patients who are hospitalized with severe COVID infection in eight countries, including in Europe and Italy and in the UK, and also Russia, Israel, Mexico, Colombia, Poland, and Brazil. So a big, robust global study, and we'll have an answer very soon if we have a new weapon in the fight against this global pandemic.

Yeah, it's a very important question and a good one. You know, these mutations and variants pose a very real risk that could set the whole world back to square one in terms of dealing with the pandemic, both for the vaccinations and also for the effectiveness of current treatments. We believe that opaganib might be able to overcome these mutations. Opaganib exerts its antiviral activity through targeting of a human host cell factor, so they act independently of the mutations to the viral spike protein. By doing this, they're expected to be active against all these emerging variants that you hear about because they cast a wide net. Again, some of these variants which may become resistant to certain direct-acting antibodies. This is very important, as the WHO Director General recently stated that we're on track for the second year of this pandemic to be far more deadly than the first year. So when we look at the overall COVID therapeutics field, we see that while vaccinations have been good, they've been effective including here in Israel, the worldwide infection rates continue to increase, and there remains an urgent unmet need for a very good treatment for COVID-19. We hope that opaganib will be that treatment.

Yeah, so this study is a blinded study, so we don't know the results. It's something that we know only when we announce it, when we unblind the data. So there's no way to know, but we have some support for a reason to be encouraged. There are several reasons for this. First, opaganib has already successfully completed a randomized controlled Phase 2 study in the United States. This was a study in 40 patients where we showed positive safety and efficacy signals. This was a patient population with severe COVID-19 who were hospitalized and required supplemental oxygen. These patients were able to show improvement in a number of key endpoints, including a greater proportion of patients who no longer required supplemental oxygen by day 4 to 13, which is a course of treatment, as well as a greater proportion of patients who showed improvement in terms of time to discharge from hospitals. Importantly, these benefits were consistent whether patients were treated with remdesivir or steroids or both as underlying standard of care. So we have good initial signals that the drug is working, and the drug is also safe. Another example of why we're excited is that we took opaganib and ran it in a preclinical model, a COVID model at the University of Louisville, where we looked at the ability of opaganib to inhibit viral replication of SARS-CoV-2. We showed that in fact there was complete inhibition after three days of incubation. So very exciting data that in a lab setting, opaganib appears to be active against COVID-19. The third is that we also have extensive preclinical data to support the broad antiviral properties of opaganib and its potent anti-inflammatory activity. Finally, during this ongoing Phase 2/3 study, we've already had several, actually four, independent safety monitoring reviews of the unblinded data that have looked at it and given us a green light to continue for safety and also once for futility. For those who may not be familiar, a Data Safety Monitoring Board is a group of experts who monitor the patient safety and the data of a clinical study while it's ongoing, because the study is blinded not just to the company but also to the participant and to the doctor. So they unblind the data, look at it, and make that determination. So those are all good signals. Again, we don't know for sure until the study is complete, but we are excited to get the results.

So we've talked a lot about opaganib and COVID, but we have a lot more going on beyond that, both in terms of R&D and commercial. Even within COVID, we have another COVID program called RHB-107 or pemistat. It originally was developed in Germany by a company called Wilex, a German company. This is a drug for a milder patient population, and we're in a clinical study with that drug. We also have a drug called RHB-204, which we're developing for NTM disease, which is a pulmonary infectious disease. It's an orphan disease with over a hundred thousand patients in the United States, and importantly, there's no approved first-line treatment, so we could be the first. We have an ongoing Phase 3 study with this drug; it's a standalone oral drug. So we're excited about those drugs and all the other drugs in our pipeline. On the commercial side, we also have a lot going on. We actually have a full commercial infrastructure in the United States that is commercializing three FDA-approved products. They are Movantik for opioid-induced constipation, a product that we acquired from AstraZeneca; also Talicia for H. pylori infection, a product that we developed in-house and got approved by FDA, and we're in the process of launching that; and finally, Aemcolo, which is a drug that we got from Cosmo, a European GI company that selected us to be their partner to commercialize this drug in the United States, and it's a drug for travelers' diarrhea. We just announced our first quarter results for 2021. We're very excited. We ended the quarter strongly. Movantik, which I mentioned we acquired from AstraZeneca last year, our new prescriptions in the first quarter outperformed the same quarter last year. Talicia also showed very nice consistent growth in prescription volume, with March, which is the last month that we reported, being our best month yet in terms of prescriptions. We also had our best week yet in March. So we're increasingly confident about Talicia's prospects and just very excited about 2021 and what the future holds for us.

Well, I think for a company of our size to have a fully integrated operation marketing three commercially FDA-approved products, in addition to a very late-stage and robust pipeline addressing many unmet medical needs, is a unique opportunity. We're fast-growing, revenue-generated, focused on very exciting areas within the biotech pharmaceutical space, including gastrointestinal disease and infectious disease. Our annualized revenues are over $80 million. We have a strong cash position of over $90 million as of our last end of Q1, which is the last time we reported. And as I mentioned, our R&D pipeline is advanced and late-stage. So we believe we're a great investment opportunity in terms of the risk-reward ratio, in terms of being a de-risked opportunity in the biotech space with a lot of promise in 2021 and the years to come.

Thank you, and Guten Tag.