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4SC announces results for financial year 2015
Solid financial and scientific basis built for launching pivotal resminostat trial in blood cancer indication CTCL
Key operating events during the 2015 financial year:
- Capital increase executed successfully with cash inflow of net EUR 27.5 million. These funds will mostly be used to carry out a pivotal Phase II trial of resminostat in the blood cancer indication of cutaneous T-cell lymphoma (CTCL).
- Stronger focus of the clinical oncology pipeline on epigenetic substances resminostat and 4SC-202 as well as further development of epigenetics expertise
- Successful entry into a licensing partnership with pharmaceutical group Menarini for the clinical development of resminostat in the Asia/Pacific region (excluding Japan).
- Partner Yakult Honsha starts a Phase I trial of resminostat in two indications - pancreatic and biliary tract cancer - in Japan. With this, at current clinical studies in resminostat are conducted in a total of five indications.
- Publication of initial promising preclinical data on resminostat's activity as an immune modulator at the ITOC2 conference.
- EU grants secured of up to EUR 0.45 million from the Eurostars program for preclinical research on the immunomodulatory properties of resminostat and 4SC-202.
- Presentation of positive data from the Phase I AEGIS study with the oncology compound 4SC-205 at the ASCO conference. The substance proved to be secure and well-tolerated; also, a recommended Phase II dosing scheme was determined.
- Experienced Pharmaceutical manager and physician Dr. Susanne Danhauser-Riedl becomes head of clinical development activities in the role of Chief Medical Officer.
Financial results for the 2015 financial year
- Cash balance/funds were at EUR 22.79 million at the end of 2015, well over the EUR 3.20 million reported at the end of 2014.
- Revenue amounted to EUR 3.27 million after EUR 7.06 million In the previous year. The decline is driven by smaller contributions from research partnerships, which are largely due to major 2014 upfront and milestone payments from partners Yakult Honsha and LEO Pharma, as well as to significantly lower revenues from cost allocations for third-party services to cooperation partners in 2015.
- EBIT improved to EUR -8.92 million (previous year: EUR -9.44 million) due to significantly lower expenses, with a corresponding improvement in the net loss to EUR 9.23 million (previous year: EUR 9.70 million).
Operational outlook for 2016
- By mid-year, 4SC plans to open initial trial centers and to recruit patients for the pivotal Phase II trial of resminostat in the CTCL indication. The trial design was discussed intensively with the European regulatory authorities EMA, so assuming the trial goes as planned, initial results could be available as early as at year-end 2018. Provided positive data, the Company would then submit an application for conditional approval in the EU on this basis.
- Results from a Phase II trial of resminostat for the treatment of liver cancer (HCC) being conducted by the Company's partner Yakult Honsha in Japan are expected to be available around mid-year. If the results are promising, 4SC will put every effort toward conducting pivotal studies in this indication in the United States and the EU as well. To accomplish this goal, it will be necessary to secure sufficient financing or to find a suitable development partner. Moreover, if the data from Japan is positive, new partner Menarini will begin to prepare clinical trials of resminostat for HCC in other countries in the Asia-Pacific region.
- The Company continues to work hard to find partnerships for 4SC-202 for Phase II development and believes the compound has great potential for creating value. The substance features an epigenetic mode of action unique to date, and 4SC has already been able to report promising results from a Phase I trial with blood cancer patients. In addition, preclinical testing indicates that 4SC-202 strengthens the body's own immune response to cancer cells.
- As for the clinical development of its third anti-cancer compound, 4SC-205, 4SC is currently reviewing possible collaborations for their clinical development.
Financial outlook for 2016
- 4SC currently estimates that the liquid funds earmarked for its financing will be sufficient into 2018 and will therefore fund the key portions of the pivotal Phase II trial of resminostat in the CTCL indication. Based on the currently planned operating activities, the Company is expecting an average monthly cash burn rate from operations for the full 2016 financial year of about EUR 1.20 million. The increase in this figure as compared with the EUR 0.77 million per month seen in 2015 results principally from starting the pending clinical CTCL study.
Enno Spillner, CEO of 4SC, said: "Thanks to the successful capital increase last year, we were able to finance most of the further development of resminostat in the niche indication of CTCL. Assuming the data is positive and we obtain regulatory approval, resminostat would be the first compound in its class coming on the market in Europe for advanced CTCL. We also expect to see results mid-year from the Phase II trial of resminostat in the liver cancer indication conducted by our partner Yakult Honsha in Japan. If the results are positive, the doors will open immediately for pivotal trials worldwide. For our second epigenetic substance 4SC-202 with its to date unique mode of action we see huge opportunity both from a scientific and an economic point of view. This means we are well prepared to take a leadership position in developing epigenetic oncology drugs and to live up to our slogan 'EpiScience for Life.'"
2015 Annual Report
The full 2015 Annual Report with detailed information on the development of 4SC, especially regarding its financial results and the outlook, is available at www.4sc.com in the Investors & Media / Financial Reports section.
Today, on 30 March 2016, at 3:00 pm CEDT (9:00 am EDT), 4SC will host a public conference call in English, in which the Management Board of 4SC AG will report on the principal developments in the 2015 financial year and beyond. Participants in the conference call can dial in with the following data:
+49 89 2030 31217 (Germany)
+44 20 3427 1900 (UK)
+1 212 444 0895 (USA)
+49 89 2030 31217 (all other countries)
Conference ID: 9624550
A presentation accompanying the conference call is available at www.4sc.com under Investors & Media / Events & Presentations / Conference Calls & Webcasts. After the event, an audio recording will be available there as well.
Resminostat is an HDAC (histone deacetylase) inhibitor administered in tablet form with an innovative epigenetic mechanism of action. The compound is available in tablet-form and 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 further showed promising anti-cancer and immunomodulatory activity.
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.
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 available 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.
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.
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