4SC provides Q3 2016 update
– Phase II study of resminostat (RESMAIN) in cutaneous T-cell lymphoma (CTCL) on track to enrole first patient in Q4 2016
– Financial outlook confirmed
– Conference call scheduled for today, 10 November 2016, at 3:00 pm CET
Planegg-Martinsried, Germany, 10 November 2016 – 4SC AG (4SC, FSE Prime Standard: VSC) today published an interim communication on the nine months ended 30 September 2016 that presents all material reporting period developments with a focus on Q3 2016 and provides the Company’s full-year outlook. The full communication is available at www.4sc.com under Investors & Media / Financial Reports.
Key events in Q3 2016 and beyond
– Dr Jason Loveridge was appointed new chief executive officer (CEO). Jason Loveridge has held senior management positions at several life sciences companies in Europe, Asia and the US. He also has significant experience managing investments in both privately-held and publicly-traded companies. He brings substantial transactional experience in the sale and partnering of biotechnology assets to 4SC.
– Dr Daniel Vitt will step down as Chief Development Officer & Chief Scientific Officer (CDO/CSO) and member of the Management Board at the end of 2016. Dr Frank Hermann, with extensive experience in clinical research, development and medical affairs in oncology, was promoted to CDO and Dr Roland Baumgartner, who has been responsible for advancing the Company’s preclinical and clinical programs, was promoted to CSO.
– Announced topline data of a subgroup analysis of the multi-center Phase II study of resminostat in liver cancer (hepatocellular carcinoma, HCC) in Japan and South Korea suggesting a survival benefit in patients with advanced HCC with resminostat. Treatment with resminostat in combination with sorafenib demonstrated a substantial overall survival benefit compared with sorafenib monotherapy in a large subgroup comprised of 84 patients (50% of all patients in the study) with a greater than median platelet count at study entry.
– Sold its immunology portfolio to Immunic. The transaction enables 4SC to fully focus on its core portfolio of epigenetic anti-cancer compounds, resminostat and 4SC-202.
– Established international Scientific Expert Panel (iSEP). The Company has appointed Prof Dr Thomas Jenuwein, Prof Dr Alexander Tarakhovsky, Dr Charles B. Epstein and Prof Dr Wolff Schmiegel, all renowned experts in the fields of epigenetics and oncology, to the panel. The iSEP will provide 4SC with strategic counsel on research and clinical product development.
– Hosted annual Scientific Symposium on “Epigenetics: Reprogramming cancer – overcoming drug resistance”, with internationally renowned experts presenting and discussing recent developments in the field of epigenetic cancer therapies.
Business outlook
– Initiation of a Phase II study of resminostat (RESMAIN) in advanced-stage cutaneous T-cell lymphoma (CTCL) in Q4 2016. The study aims to enroll 150 patients in 10 European countries at about 50 trial centers, with the goal of achieving regulatory approval for resminostat in this indication in the EU.
– Presentation of the full data set of the randomized Phase II trial of resminostat in combination with sorafenib in first-line HCC patients by Yakult Honsha and the investigators at an upcoming scientific conference.
– Planning further clinical development of the unique epigenetic anti-cancer compound 4SC-202 in patients with hematological, lung or skin cancer, particularly to explore the compound’s immuno-oncology activity and combination potential with immune checkpoint inhibitors.
– Evaluation of additional licensing deals with companies from the pharmaceutical and biotech sectors to accelerate the clinical development of 4SC’s products.
Development of cash balance in Q3 2016 and financial forecast
4SC’s cash position totaled EUR12,266 thousand as of 30 September 2016, compared with EUR13,798 thousand on 30 June 2016. The decrease was attributable to monthly use of cash from operations amounting to EUR1,230 thousand on average in Q3 2016 after EUR1,243 thousand in H1 2016. These figures are similar to the figure forecast for 2016 as a whole of EUR1,200 thousand. The deviations from forecast largely relate to slightly higher costs for preparing and running the planned Phase II clinical study of resminostat in cutaneous T-cell lymphoma (CTCL) than anticipated.
The Management Board of 4SC confirms its current financial forecast for the full year 2016 and further estimates that the funds earmarked for the Company’s financing will probably be sufficient until early 2018 and will continue to fund the planned study of resminostat in CTCL.
Dr Jason Loveridge, 4SC’s new CEO, commented:
“I accepted the position as CEO of 4SC because I see the opportunity of significant value creation based on the potential of its epigenetic pipeline and the management team’s proven ability to execute on our clinical programs. I believe 4SC is at an important inflection point as we are about to initiate the RESMAIN study in Europe, develop next steps in the clinical plan for resminostat in HCC with our partner Yakult Honsha and continue development of 4SC-202, a unique LSD1 and HDAC inhibitor with very promising activity in combination with checkpoint inhibitors. I look forward to working with the 4SC team to successfully execute the Company’s business strategy and create value for shareholders. Finally, I would like to thank Daniel Vitt for his invaluable contribution to 4SC. We wish him the best in his future endeavors.”
Conference call
4SC will host a public English-language conference call today at 3:00 pm CET, during which management will provide information on the material developments in Q3 2016 and beyond.
Dial-in numbers: |
+49 89 2030 35526 (Germany) |
|
+44 20 7026 5967 (UK) |
|
+1 719 325 2213 (USA) |
Conference ID: |
6121824 |
Presentation material for the conference call will be available at
www.4sc.com under Investors & Media / Events & Presentations / Conference Calls & Webcasts. After the conference call, an audio recording will also be available there.
– Press release ends –
Related articles
21 October 2016
Dr Daniel Vitt to step down as CDO/CSO and from the Management Board at the end of 2016 | Dr Frank Hermann promoted to CDO and Dr Roland Baumgartner to CSO
5 October 2016
Subgroup analysis suggests survival benefit in patients with advanced liver cancer treated with resminostat
28 September 2016
4SC sells immunology portfolio to Immunic
21 September 2016
Dr Jason Loveridge appointed new CEO of 4SC
8 September 2016
Epigenetics: Reprogramming cancer – overcoming drug resistance | 11th 4SC Scientific Symposium
20 July 2016
4SC forms international Scientific Expert Panel
Further information
About 4SC
4SC (www.4sc.com) is a biotech company dedicated to the research and development of small-molecule drugs focused on epigenetic mechanisms of action for the treatment of cancers with high unmet medical needs. These drugs are intended to provide innovative treatment options for cancer patients that are more tolerable and efficacious than existing therapies, provide a better quality of life and offer increased life expectancy. The Company’s pipeline comprises promising products that are in various stages of clinical development. 4SC’s aim is to generate future growth and enhance its enterprise value by entering into partnerships with pharmaceutical and biotech companies. Founded in 1997, 4SC had 47 employees as of 30 September 2016. 4SC has been listed on the Prime Standard of the Frankfurt Stock Exchange since December 2005.
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 function. 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.
4SC Corporate Communications & Investor Relations
Wolfgang Güssgen, wolfgang.guessgen@4sc.com, +49 89 700763-73
Dr Anna Niedl, anna.niedl@4sc.com, +49 89 700763-66
MC Services
Katja Arnold, katja.arnold@mc-services.eu, +49 89 210228-40
The Ruth Group
Carol Ruth, cruth@theruthgroup.com, +1 646 536 7004
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