4SC AG
4SC reports on key events in Q1 2016
DGAP-News: 4SC AG / Key word(s): Quarterly / Interim Statement/Quarter Results 4SC reports on key events in Q1 2016 EpiScience for Life – increased focus on the development of epigenetic cancer drugs Planegg-Martinsried, Germany, 12 May 2016 – 4SC AG (4SC, FSE Prime Standard: VSC), today published an interim communication on the first quarter of 2016 ended 31 March 2016 that presents all material developments in the reporting period and provides a current outlook on 2016 as a whole. The full communication is available here. Key events in Q1 2016 and beyond – 4SC receives constructive scientific advice from the European Medicines Agency (EMA) for the execution of the planned Phase II trial of resminostat in cutaneous T-cell lymphoma (CTCL). – The US Food and Drug Administration (FDA) approves 4SC’s Investigational New Drug (IND) application for running a clinical trial with resminostat in combination with the standard therapy sorafenib as first-line therapy for patients with advanced liver cancer (HCC). – 4SC presents positive data from preclinical research into the epigenetic compound 4SC-202 at the ITOC3 conference in Munich, Germany. 4SC-202 strengthens the body’s own immune response to cancer cells, which results in attractive new opportunities for clinical development. – Enno Spillner, Chairman of the Management Board of 4SC AG, will not extend his term of office but will continue to act in his role until 30 June 2016. – A new corporate image was developed with the slogan “4SC – EpiScience for Life” in line with the Company’s focus on epigenetic treatments to fight cancer and the Company’s common vision of becoming a leader in the research and development of epigenetic compounds. – 4SC increases its emphasis on the clinical development of epigenetic cancer drugs and sold the operations of its Discovery division to BioNTech effective 29 April 2016 while retaining the product candidates for the time being. Development of cash balance/funds in Q1 2016 and financial forecast The cash balance/funds of 4SC decreased from EUR22,794 thousand on 31 December 2015 to EUR17,121 thousand on 31 March 2016. This decrease was attributable to – Development costs for the planned clinical Phase II trial of resminostat in the indication of CTCL. – The repayment in full of a shareholder loan from Santo Holding (Deutschland) GmbH and the payment of interest on this loan, which was first drawn down in June 2014. The Management Board of 4SC confirms its existing financial forecast for the full year 2016 of an average monthly use of cash from operations of EUR1,200 thousand. The Management Board further estimates that the funds earmarked for the Company’s financing will probably be sufficient until after the start of 2018. This will cover the material portions of the planned clinical Phase II trial of resminostat in CTCL, in which 150 patients are to be included. Enno Spillner, Chairman of the Management Board of 4SC AG, commented: “We made a very positive start to 2016. As expressed by our new slogan “EpiScience for Life,” we want to establish 4SC even better as a leading company in the clinical development of epigenetic cancer drugs. The preparations of our important Phase II trial of resminostat in cutaneous T-cell lymphoma (CTCL) are in full swing and have almost been completed. We therefore expect the first study centers to be opened in Q2 2016 and the first data to be available ideally by the end of 2018. Should these data be positive, we plan to apply for market approval as early as 2019. Furthermore, the newly available, highly encouraging immunological data on 4SC-202 confirm the great potential of our second promising epigenetic substance. These data now open up additional possibilities for the clinical development of 4SC-202, for example as a treatment approach for patients with hematological tumors or small-cell lung cancer in combination with established immunotherapeutic treatments.” Conference call 4SC will host a public conference call in English today at 4:00 pm CEDT, during which the management will provide information on the material developments in Q1 2016 and beyond.
Presentation material for the conference call will be available here. After the conference call, an audio recording will also be available there. – Press release ends – Further information About 4SC 4SC (www.4cs.com) is a biotechnology 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 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 71 employees at 31 March 2016. On 1 May 2016, after the takeover of the Discovery division by BioNTech, the Company had 50 employees. 4SC has been listed on the Prime Standard of the Frankfurt Stock Exchange since December 2005. About Resminostat Resminostat is an HDAC (histone deacetylase) inhibitor with an innovative epigenetic mechanism of action. The compound, which is administered as a tablet, has already been clinically tested for treating Hodgkin’s lymphoma as well as liver, lung, colon, pancreatic, and biliary tract cancer. In new preclinical models, resminostat also showed promising anti-tumoral and immunomodulatory activity. About 4SC-202 Administered as a tablet, 4SC-202 is an epigenetic oncology compound with a unique therapeutic profile. In a Phase I trial of the treatment of advanced hematological cancer, 4SC-202 proved to be safe and well tolerated. In addition, initial indications of efficacy were determined. 4SC-202 works as a selective inhibitor of LSD1 (lysine-specific demethylase 1) and HDAC (histone deacetylase) 1, 2 and 3. 4SC-202 also strengthens the endogenous immune response to cancer tissue. About 4SC-205 4SC-205 is a cancer compound that inhibits the so-called “kinesin spindle protein (Eg5)”, which plays a key role in cell division and therefore the growth of cancer cells. Cell division inhibitors are deployed with great success in oncology, although they have serious side effects. Due to 4SC-205’s special mode of action, the compound does not cause such side effects. To the best of the Company’s knowledge, 4SC-205 is also the only Eg5 inhibitor administered as a tablet that is currently in clinical development anywhere in the world. In a Phase I study completed in 2015, the substance has already shown to be safe and well-tolerated; initial indications of efficacy were also determined. Forward-looking information This press release contains certain forward-looking statements. Any forward-looking statement applies only on the date of this press release. By their nature, forward-looking statements are subject to a number of known and unknown risks and uncertainties that may or may not occur in the future and as a result of which the actual results and performance may differ substantially from the expected future results or performance expressed or implied in the forward looking statements. No warranties or representations are made as to the accuracy, achievement or reasonableness of such statements, estimates or projections, and 4SC AG has no obligation to update any such information or to correct any inaccuracies herein or omission herefrom which may become apparent. Related items 29 April 2016, 4SC to focus on development of epigenetics clinical programs, sells operations of Discovery division 30 March 2016, 4SC announces results for financial year 2015
4SC AG 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
2016-05-12 Dissemination of a Corporate News, transmitted by DGAP – a service of EQS Group AG. |
Language: | English | |
Company: | 4SC AG | |
Am Klopferspitz 19a | ||
82152 Planegg-Martinsried | ||
Germany | ||
Phone: | +49 (0)89 7007 63-0 | |
Fax: | +49 (0)89 7007 63-29 | |
E-mail: | public@4sc.com | |
Internet: | www.4sc.com | |
ISIN: | DE000A14KL72 | |
WKN: | A14KL7 | |
Listed: | Regulated Market in Frankfurt (Prime Standard); Regulated Unofficial Market in Berlin, Dusseldorf, Munich, Stuttgart, Tradegate Exchange | |
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