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4SC AG. (3/20/19). "Press Release: 4SC AG Provides Results for Financial Year 2018 and Outlook". Planegg-Martinsried.

Organisations Organisation 4SC AG (FSE: VSC)
  Group 4SC (Group)
  Organisation 2 Yakult Honsha Co., Ltd.
  Group Yakult Honsha (Group)
Products Product resminostat (4SC-201, Kinselby)
  Product 2 domatinostat (4SC-202)
Person Person Loveridge, Jason (4SC 201609– CEO)

> Solid progress on advancing clinical pipeline

> Conference call scheduled for today, 20 March 2019, at 3:00 pm CET (10:00 am ET)

4SC AG (4SC, FSE Prime Standard: VSC) today published the financial results for the financial year ended 31 December 2018, presenting all material reporting period developments and provides an outlook for 2019. The full report is available at 4SC’s website.

Key highlights of 2018 and 2019 YTD

> 4SC continued to make solid progress on clinical development of both resminostat and domatinostat (4SC-202)

> More than two thirds of patients recruited for pivotal RESMAIN study of resminostat in advanced-stage cutaneous T-cell lymphoma (CTCL); positive safety outcomes to date

> Phase II study of resminostat plus S-1 chemotherapy versus S-1 chemotherapy plus placebo as second-line treatment in Japanese patients with biliary tract cancer initiated by Yakult Honsha Co., Ltd. (Yakult Honsha), 4SC’s development partner for resminostat in Japan

> Completed second dose cohort of Phase Ib/II study SENSITIZE of domatinostat in combination with pembrolizumab in advanced-stage melanoma; positive safety outcomes to date; third dose cohort started

> Initiated investigator-initiated Phase II study EMERGE of domatinostat in combination with avelumab in microsatellite-stable gastrointestinal tumors

> Published preclinical data on combination of domatinostat with either chemotherapy or several immunotherapeutic agents leading to evaluation of further clinical combination trials

> Strengthened patent protection for Hedgehog/GLI signaling inhibitor 4SC-208 in the U.S., China, Japan, Singapore, Australia and New Zealand.

> Received milestone payments from several partnered programs.

Jason Loveridge, Ph.D., CEO of 4SC, said: “4SC continues to make excellent progress with the development of our portfolio of drug candidates.

We expect that the two ongoing clinical trials of domatinostat will provide clinical evidence to further support the efficacy of domatinostat in patients that do not benefit from immunotherapeutic treatment with checkpoint inhibitors (SENSITIZE study, melanoma) or in a historically checkpoint inhibitor non-responsive indication (EMERGE study, microsatellite-stable gastrointestinal cancer). Taken together, we expect these studies to drive initiation of a pivotal clinical study of domatinostat in the aggressive rare skin cancer Merkel-cell carcinoma.

For resminostat, we expect to enroll sufficient patients in the pivotal RESMAIN study in 2019 to observe the required 125 events to unblind the study. Should the trial prove positive, we plan to submit applications for marketing approval of resminostat in CTCL in Europe, and potentially the U.S., and Yakult Honsha will submit in Japan. 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 in either Europe, Japan or the U.S.

The main goal of all our activities is to create significant benefit for patients and value for our shareholders by bringing resminostat and domatinostat to market as soon as possible.”

Business outlook

> Top-line data of the pivotal RESMAIN study expected in H1 2020.

> Results of Yakult Honsha’s Phase II study of resminostat in biliary tract cancer to be available by mid-2020.

> SENSITIZE study expected to complete in H1 2019.

> Safety data of EMERGE expected in Q2 2019 and early efficacy data in H2 2019

> Expand clinical development for domatinostat and initiate potentially pivotal study in Merkel-cell carcinoma

Cash balance development in full year 2018 and financial forecast

As of 31 December 2018, 4SC holds cash balance/funds of €25.0 million, as compared to €41.3 million as of 31 December 2017. The average monthly use of cash from operations in 2018 was €1.357 million (2017: €0.723 million), which is within the €1.3 million to €1.5 million forecast in the previous Q3 announcement. The increase of the monthly use of cash and the decrease in cash balance/funds in 2018 was mainly driven by investments in the ongoing clinical studies RESMAIN and SENSITIZE.

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 for the next twelve months. For 2019, 4SC is expecting an average monthly use of cash from operations of between €1.4 million and €1.6 million. For 2019, 4SC expects the net loss to be similar to 2018. 4SC is expecting to report similar annual net losses, with almost identical functional cost allocations in the short to medium term future as well.

Conference call

Investors, financial analysts, and journalists interested in participating in the conference call on the annual results 2018 can access via the telephone numbers stated below. Please join the event conference 5-10 minutes prior to the start time. You will be asked to provide your name, company and location as well as the access code.

Date: 20 March 2019
Time: 3 pm CET (10 am ET)
Phone Numbers: +49 (0)32 22109 8334 (Germany)
+44 (0)20 3936 2999 (United Kingdom)
+1 845 709 8568 (USA)
Joining by web (free of charge):
Access Code: 802724

A presentation document supporting the conference call will be available earlier on the same day at 4SC’s website. After the event, a replay can be accessed from there as well. [ ]

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 three key drug candidates in various stages of preclinical and clinical development: resminostat, domatinostat (4SC-202) and 4SC-208.

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 47 employees as of 31 December 2018 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.

Record changed: 2023-06-05


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