4SC provides operational and financial update for Q2 and 6M 2016

(PresseBox) ( Planegg-Martinsried, Germany, )

Phase II trial of resminostat (RESMAIN) in cutaneous T-cell lymphoma (CTCL) on track to include first patient in Q4 2016
Financial outlook for 2016 confirmed
Conference call scheduled for today, 11 August 2016, at 3:00 pm CEDT

4SC AG (4SC, FSE Prime Standard: VSC) today published its consolidated financial results and provided a business update for the six months ended 30 June 2016 as well as an update on the Company's outlook for full-year 2016. The complete half-year interim report including detailed information on 4SC's financial results is available at our webpage under Investors & Media / Financial Reports.

Business highlights in Q2 2016 and beyond 

Increased emphasis on clinical development of epigenetic cancer drugs through sale of 4SC Discovery's service business operations to BioNTech Small Molecules.
Provided topline results from Yakult Honsha's Phase II trial evaluating 4SC's epigenetic anti-cancer compound resminostat in combination with sorafenib as first-line therapy for Asian patients in Japan and South Korea with advanced liver cancer (hepatocellular cancer, HCC). A detailed analysis of data from promising patient subgroups is ongoing and will determine the companies' future development plans for resminostat in HCC.
Entered into licensing and development partnership with Link Health for the anti-cancer compound 4SC-205 in Greater China (China, Hong Kong, Taiwan, Macao). 4SC is compensated with upfront and milestone payments as well as royalties on future sales of 4SC-205, while Link Health will be responsible for the clinical development and regulatory approval processes as well as commercialization of the drug in these markets.
Presented preclinical data on epigenetic anti-cancer compound 4SC-202 at the American Society of Clinical Oncology (ASCO) Annual Meeting in Chicago, USA. 4SC-202's epigenetic mechanism of action makes resistant tumors receptive to treatment with checkpoint inhibitors, enabling attractive new opportunities for clinical development.
Presented preclinical data on epigenetic anti-cancer compound resminostat at Cancer Immonotherapy and Combinations Congress in Boston, USA. Resminostat not only supports the body's own immune system in its fight against cancer but also substantially enhances the effect of immunotherapeutic anti-cancer compounds, opening up new therapeutic combination options.
Established international Scientific Expert Panel (iSEP). 4SC has appointed Prof Dr Thomas Jenuwein, Prof Dr Dr Alexander Tarakhovsky, Dr Charles B. Epstein and Prof Dr Wolff Schmiegel to the panel, all renowned experts in the fields of epigenetics and oncology. The iSEP will support 4SC in further expanding its leadership position in the development of epigenetic cancer drugs.

Business outlook 

Phase II trial of resminostat (RESMAIN) in advanced cutaneous T-cell lymphoma (CTCL) to initiate in Q4 2016. The trial aims to enroll 150 patients in 10 European countries at 50 trial centers, with the goal of achieving regulatory approval for resminostat in this indication in the EU.
Continued analysis of detailed results of Yakult Honsha's Phase II trial of epigenetic anti-cancer compound resminostat in HCC for Asian patients in Japan and South Korea. In the event that further positive subgroup data could be stratified, 4SC expects that its partners Menarini AP and Yakult Honsha will outline their development plans for resminostat in HCC in the Asia-Pacific region.
Further clinical development of the epigenetic anti-cancer compound 4SC-202, particularly to explore its immuno-oncology activity and combination potential with immune checkpoint inhibitors.
Evaluation of additional collaboration and licensing deals with companies from the pharmaceutical and biotech sectors to accelerate the clinical development of 4SC's products.

Development of cash balance/funds in Q2 2016 and financial forecast

4SC's cash balance/funds totaled EUR 13,798 thousand on 30 June 2016, compared with EUR 17,121 thousand on 31 March 2016.

The management of 4SC reaffirms its financial outlook for the full year 2016 of an average monthly use of cash from operations of EUR 1,200 thousand. Management further estimates that the Company's current cash position is likely to be sufficient to fund operations into 2018. This will cover the material portions of the RESMAIN trial.

4SC projects that it will receive cash inflows from the partnerships with Yakult Honsha and Menarini AP later than originally assumed, because the detailed analysis of the results of the Phase II resminostat trial conducted by Yakult Honsha in HCC is still ongoing. This effect is largely offset by the cost savings related to the sale of 4SC's discovery operations and the proceeds of the 4SC-205 out-licensing agreement with Link Health.

Dr Daniel Vitt, Chief Scientific Officer and Chief Development Officer at 4SC, commented:

"We are pleased that preparations for our own Phase II trial of resminostat (RESMAIN) in cutaneous T-cell lymphoma (CTCL) are on track to initiate this study in Q4 2016.

We look forward to receiving the detailed subgroup analysis from our Japanese development partner Yakult Honsha from the recently completed Phase II trial of resminostat in combination with sorafenib as a first-line therapy in advanced HCC. These findings are particularly important for us as they will guide the future development path of resminostat in HCC.

Furthermore, the highly encouraging immunological data on 4SC-202 confirm the significant potential of our second, highly promising, epigenetic candidate. This preclinical data creates additional opportunities for the clinical development of 4SC-202, including its evaluation as a combination therapy with established immunotherapy agents."

Conference call

4SC will host a public English-language conference call today at 3:00 pm CEDT, during which the management will provide information on the material developments in 6M 2016 and beyond.

Related articles

16 June 2016, Resminostat boosts cancer immunotherapy

2 June 2016, 4SC at ASCO: 4SC 202 and checkpoint inhibitors - strong partners in cancer treatment

31 May 2016, 4SC enters into licensing and development partnership with Link Health for the cancer compound 4SC 205 in China

Further information

About epigenetic cancer therapy

Epigenetic changes modify the activation of certain genes, but not the genetic code of DNA itself, causing activation or silencing of genes. This mechanism enables differentiated cells such as those in the lungs, nerves or skin to serve very different functions despite containing identical genetic code.

Epigenetic alterations are as important as genetic mutations in a cell's transformation to cancer, and their manipulation holds great promise for cancer therapy. Epigenetic compounds such as 4SC's resminostat and 4SC-202 may convert these epigenetic alterations back to normal. For example, treatment with epigenetic cancer compounds interrupts or combats the mechanism that is responsible for the onset of cancer, makes cancer cells visible to the body's own immune system or renders them more responsive to immuno-oncological treatment.

Epigenetics is considered as a future growth market in the field of Oncology based on its significant promise as both a monotherapy and in combined approaches with immuno-oncology drugs and other therapeutic agents. In an October 2015 report by business information publisher Grand View Research, the worldwide epigenetics market was projected to generate revenues of US-$16 billion in 2022, up from US-$ 4 billion in 2014.

Forward-looking information

Information set forth in this press release contains forward-looking statements, which involve a number of risks and uncertainties. The forward-looking statements contained herein represent the judgement of 4SC as of the date of this presentation. 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.
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