4SC AG provides results for financial year 2019 and outlook

• Supply deal with Merck KgaA enables MERKLIN 2 study to commence in 2020
• Solid progress on advancing a widening clinical pipeline
• Raised a total of €33.4 million in new equity capital to complete RESMAIN & initiate key studies with domatinostat

Planegg-Martinsried, Germany, 25 March 2020 – 4SC AG (4SC, FSE Prime Standard: VSC) today published the financial results for the financial year ended 31 December 2019, presenting all material reporting period developments and provides an outlook for 2020. The full report is available at 4SC’s website.

Key highlights of 2019 and 2020 YTD

• Recruited 150 patients for pivotal RESMAIN study of resminostat in cutaneous T cell lymphoma (CTCL)
• Completed the first three cohorts of the Phase Ib/II study SENSITIZE of domatinostat in combination with pembrolizumab in melanoma and presented safety and efficacy data at the ESMO Congress 2019 (congress by the European Society for Medical Oncology)
• Enrolled the first two of three cohorts of the Phase IIa part of the EMERGE study of domatinostat in combination with avelumab in micro-satellite stable gastrointestinal cancer patients
• DONIMI study of domatinostat in combination with checkpoint blockade in the neoadjuvant setting in stage III melanoma patients was initiated by the Netherlands Cancer Institute
• Raised a total of €33.4 million in new equity capital
• Received milestone payments from partnering agreements.

Jason Loveridge, Ph.D., CEO of 4SC, said: “2019 saw 4SC make significant strides forward, especially with domatinostat; having released at ESMO data to substantiate its favorable safety profile and clinical efficacy from the combination with pembrolizumab in a very hard to treat,  checkpoint refractory patient population, whilst also confirming its immunological effect in these patients. The supply deal with Merck KgaA, executed early in 2020, helps to validate the potential of domatinostat and enables us to move forward into a first study in Merkel cell carcinoma patients who have relapsed or are refractory to checkpoint blockade. Finally, and of great interest to us, will be the DONIMI study in the neoadjuvant setting in melanoma, a very innovative positioning in earlier stage patients where we believe domatinostat has the potential to generate significant patient benefit in combination with checkpoint blockade.

For resminostat in 2019 recruitment continued steadily in RESMAIN and in 2020 we aim to continue enrollment towards the 190 patients projected to be sufficient to observe the 125 events required to unblind the study and hopefully move forward and submit applications for marketing approval of resminostat in CTCL in Europe and Japan as well as scientific advice from FDA. If approved, resminostat would be the first histone deacetylase inhibitor approved for CTCL in Europe and the first and only drug approved for maintenance therapy in this indication.

The company is well financed with cash into the second half of 2021 and we look forward to seeing additional data from our domatinostat programs in 2020.”

Business outlook for 2020

Domatinostat

• Publish updated data from the SENSITIZE study in melanoma patients refractory to checkpoint blockade
• Complete Phase IIa part of EMERGE study in micro-satellite stable gastrointestinal cancer
• Initiate (first patient enrolled) of the Phase IIb part of the EMERGE study
• Initiate the MERKLIN 2 study in Merkel cell carcinoma patients who are refractory to checkpoint blockade
• Recruitment of the DONIMI study of domatinostat in the neoadjuvant setting in melanoma

Resminostat

• Advance recruitment in the pivotal RESMAIN study so as to see the 125 events required to unblind the study in 2021

Given the current global situation with respect to Covid-19, it is pragmatic to assume that this could potentially impact 4SC’s business and the Company will update investors when a more definitive assessment of the situation can be made.

 Cash balance development in full year 2019 and financial forecast

As of 31 December 2019, 4SC holds cash balance/funds of €45,765 thousand (31 December 2018: €25,036 thousand). The average monthly use of cash from operations in 2019 was €1,093 thousand (2018: €1,357 thousand), which was lower than the €1,300 thousand to €1,600 thousand forecasted in the previous Q3 announcement as a result of later expenses related to the start of new clinical studies.

Taking into account the current financial planning and the intended operating activities, the Management Board estimates that current funds should be sufficient to finance 4SC into the second half of 2021. For 2020, 4SC is expecting an average monthly use of cash from operations of between €2,200 thousand and €2,600 thousand. For 2020, 4SC estimates the net loss to nearly double compared to 2019 as it plans to increase clinical activities for its main drug candidates significantly in accordance with its business plan. 4SC expects to continue to report annual net losses, with almost identical functional cost allocations, in the short to medium term future.

About 4SC

4SC AG is a clinical-stage biopharmaceutical company developing small-molecule drugs that can target key indications in cancer with high unmet medical needs. 4SC’s pipeline is protected by a comprehensive portfolio of patents and currently comprises two drug candidates in clinical development: resminostat and domatinostat.

4SC aims to generate future growth and enhance its enterprise value by entering into partnerships with pharmaceutical and biotech companies and/or the eventual marketing and sales of approved drugs in select territories by 4SC itself.

4SC is headquartered in Planegg-Martinsried near Munich, Germany. The Company had 44 employees as of 31 December 2019 and is listed on the Prime Standard of the Frankfurt Stock Exchange (FSE Prime Standard: VSC; ISIN: DE000A14KL72).

Forward-looking information

Information set forth in this press release contains forward-looking statements, which involve risks and uncertainties. The forward-looking statements contained herein represent the judgement of 4SC as of the date of this press release. Such forward-looking statements are neither promises nor guarantees but are subject to a variety of risks and uncertainties, many of which are beyond 4SC’s control, and which could cause actual results to differ materially from those contemplated in these forward-looking statements. 4SC expressly disclaims any obligation or undertaking to release any updates or revisions to any such statements to reflect any change in its expectations or any change in events, conditions or circumstances on which any such statement is based.