4SC AG
Press Release: 4SC announces financial results for the first half of 2015
4SC AG / Key word(s): Half Year Results Press Release 4SC announces financial results for the first half of 2015 Planegg-Martinsried, Germany, 6 August, 2015 – 4SC AG (Frankfurt, Prime Standard: ISIN DE000A14KL72, VSC), a discovery and development company of targeted small molecule drugs for cancer and autoimmune diseases, today published its consolidated financial results for the first six months of 2015 (1 January – 30 June 2015). Key operating events in Q2 2015 and beyond: – 4SC AG: Successful capital increase in return for cash and in-kind contributions strengthens financial position: Gross issue proceeds of EUR 29 million at upper end of targeted issue range; financing of planned clinical Phase II trial of resminostat in CTCL tumour indication and further operations secured until into second half of 2018. At the same time, substantial portions of a shareholder loan converted into equity, reducing liabilities significantly. – Resminostat: Main clinical focus on cutaneous T-cell lymphoma (CTCL). In this niche indication with high medical need, 4SC aims at conducting a Phase II trial which ideally would result in first market approval (“conditional approval”). Development in liver cancer in Western patients is to be advanced further once data from an Asian Phase II trial of 4SC’s partner Yakult is available. – Resminostat: Partner Yakult Honsha starts Phase I trial in two further indications of pancreatic and biliary tract cancer in Japan. Its main goal is to determine a dosing scheme for potential subsequent Phase II trials. – Resminostat: Menarini AP, Singapore, becomes new licensing and development partner for Asia-Pacific excluding Japan; agreement has potential upfront and milestone volume of up to EUR 95 million plus double-digit percentage royalties. – Resminostat: Patent protection of lead compound strengthened further in North America. – 4SC-205: Positive results on safety, pharmacokinetics and efficacy of oral anti-mitotic Eg5 inhibitor from Phase I trial in patients with solid tumours published at ASCO oncology conference in Chicago. Key financial figures for the first half of 2015: – Consolidated half year revenue amounted to EUR 2.49 million (H1 2014: EUR 3.98 million). Second quarter 2015 (EUR 0.50 million) significantly down compared with the prior-year period (Q2 2014: EUR 2.54 million), which included a milestone payment from Yakult and higher payments from collaborations in the Development and Discovery segments. – Operating result (EBIT) improved to EUR -3.70 million in the reporting period (H1 2014: EUR -3.87 million); operating result in the second quarter down to EUR -2.37 million (Q1 2014: EUR -1.75 million) due to lower revenue. – Cash balance as at 30 June 2015 markedly improved to EUR 0.91 million as a result of the capital increase completed subsequent to the reporting period. Enno Spillner, CEO of 4SC AG, commented: “We are looking back at an eventful first half of 2015, in which we were able to improve the operating and financial position of 4SC AG significantly. Our rights issue generated income of EUR 29 million, which is at the upper end of the targeted proceeds range. We both received strong support from existing shareholders and succeeded in acquiring important new investors, among them acknowledged life science specialists. Our plan is to use the funds in particular for the implementation of the clinical Phase II trial of resminostat in CTCL but also for financing the Company’s further research and development activities, including the preparation of studies with our two other cancer drugs, 4SC-202 and 4SC-205.” Enno Spillner continued: “Cutaneous T-cell lymphoma (CTCL) is a type of cancer with a very high medical need. In Europe, there are currently only a few treatment options available for advanced stages of the disease, none of which offer prospects of recovery. At the same time, we believe that this indication has attractive market potential. Provided the data is positive, we could ideally use the study results, which will probably be available in the second half of 2018, to apply for conditional approval in Europe. 4SC’s first approved drug might therefore become a reality faster than originally planned. We believe that resminostat also has significant potential in indications other than CTCL. The ongoing Phase II trials of our Japanese partner Yakult in liver cancer and lung cancer are already in a very advanced stage. Based on their results, we want to push ahead with the development of resminostat in Western patients, especially in liver cancer.” Telephone conference Today, on 6 August 2015, at 4:00 pm CEDT (10:00 am EDT), 4SC will host a telephone conference in English, in which the Management Board of 4SC AG will report on the principal developments in the second quarter of 2015 and beyond. To participate in the telephone conference, please use the following data: +49-89-2030-31218 (Germany) After the telephone conference, an audio replay will be available at www.4sc.com under Investors / Events & Presentations / Conference Calls & Webcasts. Detailed financial review: The 4SC Group, which comprises 4SC AG and its wholly-owned subsidiary 4SC Discovery GmbH, reports consolidated figures for the Group in accordance with International Financial Reporting Standards (IFRSs) and financial figures for the two operating segments, Development and Discovery & Collaborative Business. For more information on segment reporting, see the full half-yearly report at (http://4sc.de/investors/financial-reports). 6 months 2015: Despite the decline in revenue, the Company’s operating result improved slightly by 4% to EUR -3.70 million in the first half of 2015 (H1 2014: EUR -3.87 million). The net loss for the period amounted to EUR 3.95 million (H1 2014: EUR 3.97 million). For the first six months of 2015, this translates into a loss per share of EUR 0.39 (H1 2014: EUR -0.39, adjusted based on the lower number of shares after the capital reduction). The average monthly outflow of cash from operations in the first half-year amounts to EUR 0.55 million, which is below the prior-year figure of EUR 0.65 million. As at 30 June 2015, the Company had cash totalling EUR 0.91 million. Q2 2015: Successful capital increase Review of operations in Q2 2015 and outlook for 2015: Development segment (clinical development activities of 4SC AG) Resminostat: Furthermore, 4SC continued its activities with resminostat in the reporting quarter in connection with immune priming. The results from initial preclinical testing suggest that resminostat is able to activate the immune system in a specific fashion and thus can possibly improve the response rates of certain cancer immunotherapy treatments such as checkpoint inhibitors. The signing of a licence and development agreement for resminostat for the Asia/Pacific region excluding Japan with Menarini AP, a Singapore-based subsidiary of the Italian pharmaceutical multinational Menarini Group, in April 2015 represents an important milestone. Menarini AP is currently evaluating its development plans for resminostat. In addition to possible income from performance-based milestone payments and double-digit royalties, 4SC hopes that this collaboration with Menarini in conjunction with the ongoing clinical trials of Yakult Honsha in Japan will deliver important insights for the possible future development of resminostat also in Western patients, especially in the liver cancer indication. In June 2015, 4SC’s Japanese development partner Yakult Honsha launched a Phase I trial with resminostat as monotherapy or in combination with chemotherapy in up to 44 Japanese patients with advanced pancreatic or biliary tract cancer. The open-label study investigates safety, pharmacokinetics, biomarkers and efficacy of various dosing schemes. Its main goal is to determine the recommended dosing scheme for potential subsequent Phase II trials. At the same time, 4SC’s Japanese partner Yakult Honsha has pushed ahead with its ongoing Phase II trials with resminostat in the indications of liver cancer (HCC) and lung cancer (NSCLC). In the reporting quarter the US Patent Office granted the patent for the use of resminostat in cancer indications. In Canada, the composition of matter patent was granted for resminostat. This further strengthens the patent protection of 4SC’s lead compound in Western markets. 4SC-202: 4SC-205: Discovery & Collaborative Business segment (4SC Discovery GmbH): Financial outlook: At the beginning of the third quarter of 2015, 4SC was able to generate gross issue proceeds of EUR 29 million from a capital increase. The Company’s Management Board estimates that, in the context of its current financial planning, the funds will probably be sufficient until into the second half of 2018 and will serve to finance and carry out the planned Phase II trial of resminostat in CTCL and further business activities, such as the preparation of the Phase II development of the cancer programmes 4SC-202 and 4SC-205. Based on current financial planning and the operating activities announced, the Management Board is expecting an average cash burn rate from operations for 2015 as a whole that is significantly higher than in the last forecast. This increase, which is in line with planning, is predominantly due to the costs of preparing the planned Phase II clinical trial of resminostat in the CTCL indication. Accordingly, it is expected that operating expenses in 2015 will be higher than in 2014 and that 4SC’s consolidated net loss will be up year-on-year. The detailed financial planning for 2015 is currently being reviewed and the Company will specify its guidance with the publication of its nine-month report. Release ends About 4SC 4SC discovers and develops targeted, small-molecule drugs for treating diseases with high unmet medical needs in various cancer and autoimmune indications. These drugs are intended to provide innovative treatment options that are more tolerable and efficacious than existing therapies, and provide a better quality of life. 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 a headcount of 68 employees (60 FTEs) at 30 June 2015. 4SC AG has been listed on the Prime Standard of the Frankfurt Stock Exchange (ISIN DE000A14KL72) since December 2005. Cautionary statement regarding forward-looking statements 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. For more information please visit www.4sc.com or contact: 4SC AG MC Services The Trout Group 2015-08-06 Dissemination of a Corporate News, transmitted by DGAP – a service of EQS Group AG. The issuer is solely responsible for the content of this announcement. The DGAP Distribution Services include Regulatory Announcements, Financial/Corporate News and Press Releases. Media archive at www.dgap-medientreff.de and www.dgap.de |
Language: | English | |
Company: | 4SC AG | |
Am Klopferspitz 19a | ||
82152 Martinsried | ||
Germany | ||
Phone: | +49 (0)89 7007 63-0 | |
Fax: | +49 (0)89 7007 63-29 | |
E-mail: | public@4sc.com | |
Internet: | www.4sc.de | |
ISIN: | DE000A14KL72 | |
WKN: | A14KL7 | |
Listed: | Regulated Market in Frankfurt (Prime Standard); Regulated Unofficial Market in Berlin, Dusseldorf, Munich, Stuttgart, Tradegate Exchange | |
End of News | DGAP News-Service |
383943 2015-08-06 |