Thank you, operator, and welcome everyone to today's 4SC conference call on key developments in the first half of 2022, as well as our outlook for the remainder of the year. I will give you my review of the first half of the year, and then we'll open up the call for questions. I'm sure you've all already seen our press release this morning, and the presentation for this call is also 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 give some 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 with the review, I would like to give you 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 related 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 the number of factors. With those formalities out of the way, I'll now move to the main presentation and refer you to slide two of that presentation, which is the disclaimer which everybody is quite familiar with and can read at their leisure. Moving to the third slide on the presentation. This is a summary slide of the last six months. As you will know from our Q1 update, we discontinued the domatinostat program in February of this year, and so our focus now is on the development of resminostat in cutaneous T-cell lymphoma in the pivotal RESMAIN study. That study is now closed to recruitment, and we have a total of 201 patients available, for endpoint assessment in that study. We have observed around 93% of the events that we require for unblinding that study, and as such, we expect it to be unblinded in the first quarter of 2023. As previously guided, we expect top-line data to be available in the second quarter of 2023. As a result of the discontinuation of the domatinostat program and the focus on RESMAIN, we have reduced the number of employees in the company. At the end of the second quarter, we had a total headcount of 28 full-time employees. We expect this number to be further reduced through the remainder of 2022. At the end of the second quarter, the market capitalization of 4SC was around EUR 13.5 million with EUR 18 million in cash. We have sufficient cash on the balance sheet to see the company execute on its current plan well into the fourth quarter of 2023. Moving to the next slide. This is simply a reminder that the company does have a number of programs that are outsourced or partnered with different groups, including resminostat for Japan with Yakult Honsha. In the first half of this year, there's no update on any of these particular programs. Moving to slide five and the financial review and outlook for 4SC. At the thirtieth of June 2022, the company had just over EUR 17.7 million on its balance sheet. The average monthly use of cash during the first half of 2022 was just over EUR 1.3 million per month, which was below the previous forecast of EUR 1.5 million-EUR 1.8 million per calendar month. We expect the average monthly operational cash use to be maintained at the previous guidance for the remainder of 2022, and that the funds that we currently have at bank are expected to finance 4SC into fourth quarter of 2023. Moving to slide six, the key milestones for 2022 and 2023. Now that recruitment is closed for the RESMAIN study, we expect to observe more than 95% of the progression-free survival events in RESMAIN in 2022. Which will place us in a position in the early part of 2023 to see an unblinding of the pivotal RESMAIN study in the first quarter, and as I said earlier, to report top-line data for that study in the second quarter. Assuming positive outcome to the RESMAIN study, we expect to file for orphan drug designation in cutaneous T-cell lymphoma in the second half of 2023, and to seek advice from the U.S. Food and Drug Administration on a registration study for resminostat in CTCL in the United States. That brings me to the end of my presentation, and I pass the call back to the operator to open for any questions. Thank you, operator. Thank you, Jason. If you would like to ask a question, please press star followed by one on your telephone keypad. If you change your mind, please press star followed by two. When preparing to ask your question, please ensure your phone's unmuted locally. That's star followed by one on your telephone keypad. It appears we have no questions at this stage. Okay. Let's give them another 30 seconds, and then if there's no further questions, we'll close the call. Of course. That's star followed by one if you would like to ask any further questions. It appears we have no questions. Okay. Thank you, operator. Thanks to everybody who attended this second quarter update. At this point, we'll now close the call. Thank you, operator. Thank you, Jason. This concludes today's call. Thank you for joining. You may now disconnect your lines.
Loading workspace