Hello everyone, and welcome to the 4SC AG half year conference call. My name is Ezra, and I will be coordinating your call today. If you would like to ask a question, please press star followed by one on your telephone keypad now. If you change your mind, please press star followed by two. I will now hand you over to your host, Jason Loveridge, Chief Executive of 4SC AG, to begin. Jason, please go ahead. Thank you, Ezra, and welcome everyone to today's 4SC conf call on the key developments in the first half of 2024, as well as our outlook for the remainder of the year. I'll give you my review of the first half of the year, and then we will open up the call for questions. I'm sure you've already seen this release this morning, and the presentation for this call will be available for download on the website. You can find this in the Investor and Media section under Investor Information, and then Conference Call and Webcasts. The slides will give some support to 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 with the review, I'd like to give you all a brief reminder. Today's conference call may make projections or estimates regarding plans and objectives relating to our future operations, products, services, or future financial results, assumptions underlying or relating to any such statements, each of which constitutes a forward-looking statement subject to risk and uncertainty, many of which are beyond our control. Actual results may differ materially depending on a number of factors. With the formalities out of the way, I will start with the presentation. 2024 first half has been extremely productive for 4SC. Most foremost, we filed our marketing authorization application for our drug, resminostat, in advanced stage cutaneous T-cell lymphoma with the European Medicines Agency. In 2023, we completed the RESMAIN study and published positive data on that study and progressed to the filing in the first quarter of 2024. Subsequent to that, in the second quarter of this year, we received questions from the EMA, and our intention is to spend the second half of 2024 addressing the issues and questions raised by the EMA and their response, with the intention of refiling the submission in the last quarter of 2024. In addition, we received orphan drug designation in Switzerland, which we have now, in addition to the European Union and the United States, for resminostat in cutaneous T-cell lymphoma. We also filed a pre-NDA filing with the US FDA and received feedback on that in the second quarter of 2024. So just to remind people of the RESMAIN study, this is the study of resminostat in cutaneous T-cell lymphoma. It is a pivotal study, and the main endpoint or the primary endpoint was progression-free survival. There were 201 patients enrolled, making it one of the largest studies in CTCL, and we first reported top-line positive data in May 2023, with subsequent data in the September of 2023. I'll just summarize for you the key efficacy and quality of life outputs from that study. So this was a study, RESMAIN, where for the first time, maintenance treatment had been shown to be beneficial in advanced stage CTCL. Resminostat, or Kinselby, significantly improved progression-free survival versus placebo, with a median PFS of 8.3 months versus 4.2 months in the placebo arm. This had a P value of 0.015 and a hazard ratio of 0.6, whereas resminostat, or Kinselby, also significantly improved time to next treatment versus placebo, with a median time to next treatment of 8.8 months versus 4.2 months. Resminostat, or Kinselby, demonstrated a clinically meaningful improvement in total progression-free survival versus placebo, with a total PFS of just over 2 years versus placebo of almost 15 months. There was no significant impact of resminostat or Kinselby on either VAS itching or Skindex-29, and we believe that the FACT-G measurement was impacted by GI side effects of resminostat, i.e., predominantly nausea. With respect to safety in this study, the most frequent side effects were nausea, diarrhea, vomiting, and these were manageable, reversible, and mainly mild in nature. This clinical data has been presented by the primary investigator in the study, Professor Rudolf Stadler, from the University Hospital Johannes Wesling in Minden, in Germany, initially at the EORTC Cutaneous Lymphoma Tumor Group annual meeting in September 2023 in the Netherlands, and subsequently at the Fifth World Congress of Cutaneous Lymphomas in the United States. Both presentations were extremely well received by the clinicians present, and we believe clinicians are avidly awaiting the approval of this drug. And in that respect, going forward onto registration and our progress on that front, as I said earlier, the Marketing Authorization Application was filed in the EU with the EMA on the ninth of February and validated by EMA at the end of February 2024. We had a meeting with the EMA rapporteurs in the first quarter and received the first formal questions back from EMA at the beginning of July 2024. As I said earlier, this is our primary focus in 2024, and we will expend all our resources answering and addressing the issues raised in the response of EMA to our MAA, and expect to refile this in the fourth quarter or late in the fourth quarter, 2024. With respect to the UK and Switzerland, the intention to file for both these countries will only take place after EMA approval. With respect to the UK, in addition, we received a pediatric investigation plan waiver for resminostat from the UK MHRA in April 2024. With respect to the United States, 4SC AG filed a pre-NDA for resminostat to the US FDA, and based on the agency's response, we have decided not to pursue any further the registration of resminostat for CTCL in the United States based on the RESMAIN data. With respect to Japan, Yakult Honsha, our partner for resminostat in Japan, is in the process of preparing its filing to the Japanese PMDA and is currently waiting on the final data from the rollover arm of the RESMAIN study, i.e., the longer-term survival data, which will only be available in the fourth quarter of 2024. That's the summary of progress in terms of registration. Moving on to market entry and commercialization. We appointed a global investment bank in 2023 to help assist us in evaluating our commercial options for resminostat or Kinselby. We've held multiple discussions with potential partners, collaborators, and licensees, and are currently focused on companies with a strong primary EU presence or focus or operations in the EU. We're also assessing market entry and pricing reimbursement strategies in the EU, and have engaged a third-party contractor to assist us in this process. This is including discussions with payers and reimbursement agencies in the EU and validating our pricing assumptions for the drug in the different EU countries. We expect to conclude all this work during 2024 or after approval in 2025. That brings me to the end of my summary for the first half of 2024 for resminostat, and in conclusion, just mentioning our other drug, which was dometinostat. As you may recall, we discontinued this program in early 2022, but have managed to salvage some value from it by completing a commercial agreement for the further development of dometinostat with a US-based company, Vuja De Sciences. The collaboration is focused on evaluating dometinostat plus low-dose oral rapamycin in cancers such as recurrent metastatic osteosarcoma and refractory sarcomas. Vuja De expects the first clinical studies to begin in late 2024. 4SC AG will assist Vuja De Sciences in their efforts but and could potentially receive milestone payments, drug provision payments, and/or royalties. Although this is a good partnership for 4SC AG, it's not our core focus, and future value creation in 4SC AG is very resminostat-focused and largely dependent on EMA's assessment of 4SC AG's marketing authorization application. Coming now to the financial summary for the first half, 2024. Revenues were in line with expectations at EUR 182,000, and the loss in the first half was just below 4 million EUR. Operating costs were reduced by 18% due to a lower number of active clinical trials, and personnel expenses were also reduced by a 15% reduction in personnel compared to the previous year. Monthly use of cash was reduced to 649,000 EUR per month and will continue to be predominantly used in the conduct of clinical studies. At the end of the first half, 2024, 4SC AG had 4.425 million EUR at the bank, which would give us an expectation or an expected run rate into the first quarter, 2025. The company currently has a headcount of 15 people. That brings me to the end of my presentation, and therefore, just to round up and summarize, we completed our pivotal study, RESMAIN, and met the primary endpoint. In the first half of this year, we filed our MAA for Kinselby with EMA, and we expect to file with Switzerland and the UK following approval in the EU in 2025. Our partner, Yakult Honsha, has control of the Japanese filing. If approved, Kinselby would be the, in a unique position in the maintenance setting in CTCL, as the only HDAC inhibitor available in the EU, demonstrating positive progression-free survival and almost doubling time to progression with a 2-year total time to progression. The market potential remains interesting for 4SC AG. We believe there are still around 7,500 addressable patients in Europe, with an estimated potential sales of around EUR 500 million over first 10 years on market. We have orphan drug designation granted in the EU, Switzerland, and US, so have good commercial protection of the market opportunity. The initial market entry work with payers and reimbursement agencies confirmed our pricing assumptions, and our commercial options are currently under review. With that, I bring the presentation to a close and hand back to our operator for any questions. Thank you very much. Thank you very much. If you would like to ask a question, please press star followed by one on your telephone keypad now. When prepping to ask your question, please ensure your device is unmuted locally. To withdraw your question, please press star followed by two. We currently have no questions, so I will hand over back to Jason to conclude this call. Thanks very much, Ezra. As we have no questions, I bring the call to a close. Thank you all for your interest in the company in the first half of 2024, and we look forward to a busy second half refiling our marketing authorization application in the EU. Thank you very much. Thank you very much, everyone, for joining. This concludes today's call. You may now disconnect your lines.
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