Hello everyone, and welcome to the 4SC AG Q3 conference call. My name is Nadia, and I'll be coordinating the call today. If you would like to ask a question, please use the Q&A chat box provided. I will now hand over to your host, Jason Loveridge, CEO for 4SC AG to begin. Jason, please go ahead. Thank you, Nadia, and welcome everyone to today's 4SC conference call on key developments in the third quarter, as well as our outlook for the remainder of this year. My name is Jason Loveridge. I'm the CEO of 4SC. Today, I'll give you a short presentation, then we'll open the call up for any questions. I'm sure you've already seen our press release this morning, and the presentation for this call is available for download on the website. You can find this in the Investor and Media section under Investor Information, and then Conference Calls and Webcasts. The slides will provide support for my comments, but you should be able to follow the call even if you don't have them in front of you. Before I start the presentation, I would like to give you all a brief reminder. During today's conference call, we may make projections or estimates regarding plans and objectives relating to our future operations, products, services, or future financial results or assumptions underlying or relating to any such statements, each of which constitutes a forward-looking statement subject to risks and uncertainties, many of which are beyond our control. Actual results could differ materially depending on a number of factors. With those formalities out of the way, I'll move forward to the presentation. So if you have it, I will refer to it by slide number. On slide two, you will find the standard disclaimer, which you can read at your leisure after the call. On slide three, we start with a summary, and I think this third quarter has been an exceptional one for 4SC. We saw the landmark data from the company's RESMAIN study published at the EORTC meeting in the Netherlands. This followed the top-line data that we released during the second quarter in May 2023. With this really exceptional data, preparations are really progressing well for the marketing authorization application in the European Union, Switzerland, and the United Kingdom. We're making significant efforts in terms of preparation for discussions with the United States Food and Drug Administration regarding requirements for marketing resminostat in the United States. At the end of September, the US FDA granted orphan drug designation to resminostat, which gives us the ability to a number of benefits from FDA, as well as seven years market access. Cash burn has been reduced significantly through year to date, and the current cash runway is extended into the second half of 2024. As we announced yesterday, the EMA granted orphan drug designation to resminostat and Kinselby, so we now have orphan drug designation granted in our two major geographies, providing us with exclusive access for seven and 10 years. Moving to slide four, we see a summary of the performance of the share price year to date, and I'm pleased to say that the market has seen fit to reward the company with a good share price performance in 2023, and we now have a market capitalization exceeding EUR 100 million. The key driver of performance for the company year to date has been the RESMAIN data, and on this slide, slide five, I summarized the key data so that you can see it. RESMAIN is one of the largest randomized controlled studies in CTCL, and the study demonstrated for the first time that resminostat as maintenance therapy was able to provide a proven benefit in advanced stage cutaneous T-cell lymphoma. Resminostat significantly improved progression-free survival, improving median PFS from 8.3 months versus 4.2 in the placebo, with a strong significance of 0.015 and a hazard ratio of 0.6, which is exceptional in an oncology study. Resminostat also significantly improved the time to next treatment versus placebo, which is an incredibly important endpoint for physicians and for patients. Time to next treatment is 8.8 months in the resminostat arm versus 4.2 months in the placebo, again, with a hazard ratio around 0.6. Importantly, resminostat demonstrated a clinically meaningful improvement in total progression-free survival, with a total PFS of 24.2 months, so more than 2 years, versus 15 months in the placebo arm. Resminostat was broadly superior to placebo across a range of predefined subgroups, and you can follow this data in more detail on our website, and I would ask you to go to the webinar there to see this in more detail. The study confirmed the known safety profile of resminostat. There was no significant negative effect on either VAS itching or Skindex-29, and FACT-G was impacted by the side effect of resminostat, predominantly nausea. From a regulatory point of view, this data puts us in an excellent position to move forward with our marketing application. We filed an intention to file an eligibility request with the EMA in the second quarter of 2023, which was granted. We are now preparing our EMA submission for Kinselby as a clinical practice-changing therapy in advanced CTCL. We're focusing on maintenance therapy with the goal of preventing relapse and postponed progression, which would be a new treatment paradigm in CTCL. Our marketing application is on track to be filed in the first quarter of 2024. We're also preparing to file with the MHRA in the U.K. and Swissmedic in Switzerland. We expect those submissions to be made shortly after the MAA filing. As I said earlier, we're also in preparation of an approach to the U.S. FDA, which we intend to make in the fourth quarter of this year. To remind you, Kinselby is partnered with Yakult Honsha in Japan, where we expect to receive significant milestones and royalties if the drug is approved in that jurisdiction. Yakult Honsha is responsible for preparing the PMDA filing in Japan. 4SC retains the rights to all other geographies for the drug outside of Japan. Finally, moving to the financial review and outlook, currently, the company completed the quarter with a cash balance of just over EUR 10 million. The average monthly operational use of cash during the third quarter was reduced significantly to EUR 487,000, which is well below the forecast provided at the beginning of 2023, of between EUR 800,000 and EUR 1.1 million. Based on our current financial and operating activities, the management board of 4SC is expecting a lower than average monthly cash burn from operations of between EUR 500,000 and EUR 700,000 for the year 2023. The strong cash management has allowed us to extend our current operating time, and current funds are expected to finance 4SC into the third quarter of 2024. On slide eight, we come to the final slide of the presentation and a summary of what's been said earlier. The pivotal RESMAIN study met the primary endpoint, and we are preparing our marketing application for the EU for Kinselby. We expect this to be filed in the first quarter of 2024. We expect Yakult Honsha to file in Japan, shortly following that, in the first half of 2024. Although we have not talked about it today, we are already spending considerable time in terms of the market entry strategy. We've done some initial work with both payers and reimbursement agencies in the EU. We've validated our price assumptions with these in, individual organizations across a number of different countries in the EU. As I said earlier, our approach to the FDA in the US is well underway. Kinselby is a drug with a considerable market potential as an orphan indication in the EU. We see around about 25,000 patients available for treatment in the EU and potential sales of over EUR 600 million over the first 10 years on market. As I said earlier, both EU and US orphan drug designation have been granted, which gives us commercial exclusivity for Kinselby in these jurisdictions. We have a unique market position. We will be the only therapy in maintenance setting in CTCL. We've demonstrated a strong efficacy based on the RESMAIN study, almost doubling time to progression, providing two years total time to progression, and we will be the only HDAC inhibitor available to EU clinicians. I think this positions us very strongly for an excellent 2024, where we expect to file the marketing application and move on with the commercialization of our key asset. With that, I will open the call to questions. If people have questions, they can file them on the live dashboard with NetRoadshow. I will- at the moment, we have no questions in the queue, but I will leave it for 30 seconds. I'm just gonna refresh to see whether we have any questions. If you do have questions, please feel free to file them with NetRoadshow, and we'll endeavor to answer them. Thank you. As a reminder, if you would like to ask a question, please use the Q&A chat box provided online. I don't think we have any questions, and with that, I'd like to close the call and hand back to the operator. Thank you. Thank you, Jason. This now concludes today's call. Thank you all for joining. You may now disconnect your lines.
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