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4SC AG. (8/9/18). "Press Release: 4SC Provides Q2 and H1 2018 Update". 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)
  Product 2 domatinostat (4SC-202)
Person Person Loveridge, Jason (4SC 201609– CEO)

4SC AG (4SC, FSE Prime Standard: VSC) today published its Half-Year Report and provided a business update for the six months ended 30 June 2018 as well as the Company’s current outlook. The full report is available for download on 4SC’s webpage.

Jason Loveridge, Ph.D., CEO of 4SC, said:

“We continued to execute on the clinical development of our lead compounds resminostat and domatinostat in the second quarter. Yakult Honsha, our Japanese development partner for resminostat, joined the pivotal trial in cutaneous T-cell lymphoma (CTCL), and initiated a Phase II study in biliary tract cancer. The Phase Ib/II SENSITIZE study of domatinostat (4SC-202) + pembrolizumab in melanoma remains on track and the second dose cohort was initiated.

Furthermore, we attended an extensive program of scientific conferences and investor meetings and were pleased by the positive feedback we received from both communities. The company is well resourced to continue its current program of clinical trials through the remainder of 2018 and in 2019, when we expect to publish top-line results from the pivotal study of resminostat as well as data from both the SENSITIZE and EMERGE studies of domatinostat.”

Key highlights of Q2 2018 and beyond

> New data supporting resminostat’s mechanism of action in CTCL maintenance therapy presented at the 25th Biennial Congress of the European Association for Cancer Research (EACR).

> Safety Review Committee recommended continuation with the second dose cohort in the ongoing Phase Ib/II SENSITIZE study of domatinostat in combination with pembrolizumab in melanoma.

> The first patient was enrolled into the second dose cohort of the SENSITIZE study.

> Stifel Nicolaus Europe Limited, London, UK initiated research coverage on 4SC with buy rating.

Business outlook

> Continue enrolling patients into the pivotal RESMAIN study of resminostat in CTCL, top-line data expected in 2019.

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

> Top-line results from the first two cohorts of patients in the SENSITIZE study to be available in H2 2018, study expected to complete in H1 2019.

> Safety data of Phase II study EMERGE of domatinostat in combination with avelumab in gastrointestinal tumors is expected in Q1 2019 and early efficacy data in H2 2019.

> Continued focus on out-licensing of non-core assets.

> Ongoing partnering discussions with pharmaceutical and biotech companies to progress the clinical development of 4SC’s core pipeline assets.

Cash balance development in H1 2018 and financial forecast

4SC’s cash balance/funds amounted to EUR 34.1 million as of 30 June 2018, compared with EUR 41.3 million as of 31 December 2017. The decrease relates to an average monthly outflow of cash from operations of EUR 1.2 million compared to an average monthly outflow of EUR 0.9 million in H1 2017.

Taking this into account as well as current financial planning and the intended operating activities, the Management Board of 4SC sustains its existing financial forecast for the full year 2018 of an average monthly use of cash from operations of between EUR 1.8 million and EUR 2.0 million. The Management Board further estimates that available cash/funds should be sufficient to finance the Company into 2020.

Conference call

4SC will host a conference call today at 3 pm CEDT (9 am EDT) to discuss the key developments in the reporting period and beyond.

Interested investors, analysts, and journalists can access the call 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 the confirmation code.
Date: 9 August 2018
Time: 3 pm CEDT (9 am EDT)
Phone Numbers: +49 (0)69 2222 2018 (Germany)
+44 (0)330 336 9411 (United Kingdom)
+1 646-828-8193 (USA)
Confirmation Code: 3752167

A presentation document supporting the conference call is available 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 45 employees as of 30 June 2018 and is listed on the Prime Standard of the Frankfurt Stock Exchange (FSE Prime Standard: VSC; ISIN: DE000A14KL72).

Forward-looking statement

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: 2019-06-09


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