4SC AG provides Q2 and H1 2019 update

Conference call scheduled for today, 8 August 2019, 2 pm CEDT (8 am EDT)

 

Planegg-Martinsried, Germany, 8 August 2019 - 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 2019 as well as the Company's current outlook. The full report is available for download on .

Key highlights of Q2 2019 and beyond

• The pivotal RESMAIN study of resminostat as maintenance therapy in cutaneous T-cell lymphoma remains on track.
• The Safety Review Committee (SRC) consisting of clinical and drug safety experts evaluated the safety data from the third dose cohort in the Phase Ib/II SENSITIZE study of domatinostat in combination with the checkpoint inhibitor pembrolizumab in melanoma. The drug combination was confirmed as safe and well tolerated by the SRC at this third and highest predefined dose cohort. Thereafter, the SENSITIZE study will be expanded by a further two cohorts.
• In a second SRC meeting, the safety data of the first dose cohort of the Phase Ib/II study EMERGE of domatinostat in combination with the checkpoint inhibitor avelumab in gastrointestinal cancer was evaluated and the SRC recommended continuation with the second dose cohort. Patient recruitment for the second dose cohort has been initiated.
• Dynavax Technologies Corporation (Dynavax) presented preclinical data at the American Association for Cancer Research Annual Meeting (AACR) on the combination of orally available domatinostat with Dynavax's intra-tumoral TLR9 agonist SD-101. Dynavax also compared domatinostat to other class‑I-selective HDAC inhibitors, with domatinostat demonstrating the most significant benefit in combination with SD‑101.
• A clinical cooperation partner presented preclinical data at the AACR that confirmed domatinostat's mode of action in the aggressive skin cancer Merkel cell carcinoma.
• 4SC secured circa EUR 10.5 million net in a cash capital increase from authorized capital.

Business outlook

• The RESMAIN study is expected to enroll sufficient patients during 2019 to accumulate the 125 events - i.e. patients experiencing disease progression - required to unblind the study around the middle of 2020. Top-line results from the study would be available as soon as possible thereafter.
• The Phase II study of resminostat in combination with S-1 chemotherapy versus S-1 chemotherapy plus placebo as second-line treatment in 100 Japanese patients with unresectable or recurrent biliary tract cancer is fully enrolled and final results are expected to be available in the first half of 2020. The study is conducted by Yakult Honsha Co., Ltd., 4SC's Japanese development partner for resminostat.
• Both SENSITIZE and EMERGE are being conducted in two parts, an initial part to evaluate the safety of domatinostat in combination with checkpoint inhibitors and to determine a recommended Phase II dose, potentially followed by a second "expansion" part in order to obtain a larger data-set through the addition of more patients at the preferred dose. 4SC expects to publish results from part 1 of these two trials in the second half of 2019.
• Two investigator-sponsored trials of domatinostat in combination with checkpoint inhibitors in melanoma are expected to start in late 2019.
• 4SC plans to start two studies of domatinostat in combination with a checkpoint inhibitor in Merkel cell carcinoma in late 2019 and early 2020 and the studies might provide initial top-line data in the first half of 2021. One of the studies could potentially be considered as pivotal and sufficient for registration purposes by regulators.

Cash balance development in H1 2019 and financial forecast

4SC held cash balance/funds amounting to EUR 17.8 million at the end of H1 2019. Taking into account the proceeds from the June 2019 cash capital increase in the net amount of circa EUR 10.5 million, current financial planning and the intended operational activities, the Management Board of 4SC maintains its existing financial forecast for the full year 2019 of an average monthly use of cash from operations of between EUR 1.4 million and EUR 1.6 million. The planned extension of the development program is subject to further financing. The Management Board estimates that current funds should be sufficient to finance 4SC for at least the next twelve months.

Conference call

4SC will host a conference call today at 2 pm CEDT (8 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.

A presentation document supporting the conference call is available at . After the event, a replay can be accessed from there as well.
 

- Press release ends -

 

Further information

 

About 4SC

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: and .

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 30 June 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.

 

Contact

4SC
Anna Niedl, Ph.D., CIRO
Corporate Communications & Investor Relations