DGAP-News: 4SC provides Q3 business update and outlook

4SC provides Q3 business update and outlook

Solid progress in developing pipeline to address high unmet medical needs

Planegg-Martinsried, Germany, 25 October 2018 - 4SC AG (4SC, FSE Prime Standard: VSC) today provided a business update for the three months ended 30 September 2018, as well as its current outlook. The full report is available for download on 4SC's website.

Key highlights of Q3 2018 and beyond

• 4SC continued to make solid progress with its pipeline, which comprises three clinical studies with two products, resminostat and domatinostat (4SC-202).
• The FDA granted an IND for domatinostat to target melanoma. This enables 4SC to expand the SENSITIZE Phase Ib/II trial into the US in 2019 and further broaden its clinical program. The study is currently enrolling advanced-stage melanoma patients in Germany.
• Preclinical data showed that a combination of domatinostat with chemotherapy increased inhibition of cell growth when compared to treatment with either alone.

Jason Loveridge, Ph.D., CEO of 4SC, said: "It is deeply gratifying to see the consistent progress we are making in developing products that can make a significant difference to patients' lives. The development of resminostat in cutaneous T-cell lymphoma (CTCL), a condition for which there is currently no cure, and which affects 50,000 patients in each of the EU and the US, is a demonstration of how our approach has the potential to fundamentally change the treatment options for such serious diseases.

"With resminostat also being studied in biliary tract cancer, and domatinostat in PD-1 refractory or non-responding cutaneous melanoma and soon in microsatellite-stable gastrointestinal tumors, 4SC is delivering a broad portfolio of small-molecule drugs that can target key indications in cancer with high unmet medical needs."

Business outlook

• Recruitment of at least the first 100 patients in the pivotal RESMAIN study of resminostat in CTCL in 2018, with top-line data expected in late 2019.
• 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 early 2019. Study expected to complete in H1 2019.
• Safety data of Phase II study EMERGE of domatinostat in combination with avelumab in gastrointestinal tumors are expected in Q2 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 Q3 2018 and financial forecast

As of 30 September 2018, 4SC holds cash balance/funds of EUR30.8 million, as compared to EUR34.1 million as of 30 June 2018. The monthly use of cash from operations was below the range forecasted for 2018, amounting to EUR1.17 million on average in the first nine months of 2018 (9M 2017: EUR0.74 million).

The increase of the monthly use of cash and the decrease in cash balance/funds in the first nine months of 2018 was mainly driven by investments in the ongoing clinical studies RESMAIN and SENSITIZE.

Based on current financial planning and operating activities, the Management Board is expecting a lower average monthly cash burn rate from operations of between EUR1.3 million and EUR1.5 million for 2018, as compared to the earlier assumptions of EUR1.8 million to EUR2.0 million. The Management Board of 4SC confirms that the funds should be sufficient to finance 4SC into 2020.

- Press release ends -

Related articles

20 September 2018, Domatinostat plus chemotherapy - Overcoming drug resistance

15 August 2018, FDA approves IND application for domatinostat (4SC-202) in melanoma

31 July 2018, First patient enrolled in 2nd dose cohort of Phase Ib/II study SENSITIZE of domatinostat (4SC-202) + pembrolizumab in melanoma

3 July 2018, Positive safety review of 4SC's Phase Ib/II SENSITIZE study of domatinostat (4SC-202) + pembrolizumab in melanoma

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 46 employees as of 30 September 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.

Contact

4SC
Anna Niedl, Ph.D., CIRO
Corporate Communications & Investor Relations
anna.niedl@4sc.com
+49 89 700763-66

LifeSci Advisors
Hans Herklots
Managing Director
hherklots@lifesciadvisors.com
+41 79 598 7149