On October 19, 2023 4SC AG (4SC or "the Company") (4SC, FSE Prime Standard: VSC), a biotech company improving the lives of patients suffering with advanced-stage cutaneous T-cell lymphoma (CTCL), reported a business update for the three months ended 30 September 2023, as well as its current outlook (Press release, 4SC, OCT 19, 2023, View Source [SID1234636118]). The full report is available for download on 4SC’s website.
Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:
Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing
Schedule Your 30 min Free Demo!
4SC is focused primarily on the development of resminostat (Kinselby), and, in particular, preparation of the marketing authorisation for the commercialization of resminostat (Kinselby), a unique maintenance treatment for CTCL.
Key highlights of Q3 2023
Data from the Company’s RESMAIN study was published in September 2023 at the EORTC Cutaneous Lymphoma Tumour Group Annual Meeting. In this study, resminostat (Kinselby) showed*:
A statistically significant improvement in progression free survival (median PFS: 8.3 vs. 4.2 months; p=0.015; HR: 0.623)
A median time to next treatment versus placebo showed a significant improvement of 8.8 months compared to 4.2 months
A clinically meaningful improvement in median "total" PFS of 24.3 months, compared to 14.9 months for those in the placebo group
Side effects of resminostat were mainly mild to moderate, manageable and reversible
In Q3, 4SC has been actively progressing the preparation of its Marketing Authorization Application in the European Union, Switzerland and the United Kingdom
In addition, a significant effort has been made in preparing for discussions with the United States (US) Food and Drug Administration regarding requirements for marketing resminostat (Kinselby) for CTCL in the US
On 27 September 2023, the Company announced that the US FDA had granted resminostat (Kinselby) orphan drug designation, which gives a number of benefits, most importantly seven years’ market exclusivity in the US
4SC’s partner for Japan, Yakult Honsha Co. Ltd (Yakult Honsha) is continuing with its preparation and filing of a marketing application for resminostat (Kinselby) in Japan.
Cash balance development in Q3 2023 and financial forecast
As at 30 September 2023, 4SC held cash balance/funds of €10.44 million compared to €12.16 million as of 30 June 2023. The decrease of cash funds in the first nine months of 2023 is mainly a result of the expenditure on the ongoing RESMAIN clinical study.
The monthly use of cash from operations amounted to €487 thousand in Q3 2023. The average monthly use of cash for 2023 is now expected to be between €500 – €700 thousand, a significant reduction from the previous forecast of between €800 thousand – €1.1 million.
Based on current financial and operating activities, the Management Board estimates that current funds should now be sufficient to finance 4SC into the third quarter of 2024, longer than previously expected.
Post Period Event
In October 2023, the European Commission adopted the European Medicines Agency’s decision to grant orphan drug designation to resminostat (Kinselby) in cutaneous T-cell lymphoma (CTCL). Orphan drug designation (ODD) provides privileged status to drugs that show promise for the treatment of rare diseases in the European Union. ODD qualifies 4SC for benefits including protocol assistance, market exclusivity and fee reductions.
Jason Loveridge, Ph.D., CEO of 4SC, commented: "The last quarter has been a very busy and productive period for 4SC. Not only has the RESMAIN study demonstrated the significant benefit of resminostat (Kinselby) as a maintenance treatment for patients suffering from CTCL, a debilitating and incurable condition, but we have also secured orphan drug designation in both the US and, post period, in Europe. This designation comes with meaningful benefits, including market exclusivity for seven and ten years respectively. We remain focused on securing marketing authorization for resminostat (Kinselby) and are actively engaged in finding the right partner to take Kinselby forward to patients."