4SC AG announces results for financial year 2016
Conference call scheduled for today, 29 March 2017, at 3:00 p.m. CEDT (9 a.m. EDT)
Jason Loveridge, Ph.D., CEO of 4SC, commented:
"Since I joined the company in September 2016, we have focused our resources on our lead clinical assets, resminostat and 4SC-202. We expanded our senior leadership team and are now well set-up to further advance our products in clinical development and toward market approval.
We look forward to 2017 as a year in which we can make significant progress at 4SC. We will continue patient enrollment in our pivotal study RESMAIN of resminostat in cutaneous T-cell lymphoma (CTCL) and are actively discussing the next steps for resminostat in liver cancer (hepatocellular carcinoma, HCC) following the interesting subgroup data generated in 2016. We also plan to initiate two Phase II studies of 4SC-202 in combination with checkpoint inhibitors and to initiate formal preclinical development of 4SC-208.
Throughout 2017, we expect to make significant progress and further enhance the value of 4SC through out-licensing deals of further non-core assets."
Key highlights of 2016 and 2017 YTD
Announced positive data from subgroup analysis of the Phase II study of resminostat in combination with sorafenib as first-line therapy in 170 Asian patients with advanced-stage HCC conducted by Yakult Honsha Co., Ltd., which showed a substantial increase in overall survival in patients with above the median platelet levels at study entry (50% of study population).
Received investigational new drug approval (IND) from the U.S. Food and Drug Administration (FDA) to conduct a clinical study of resminostat in combination with sorafenib in HCC.
Initiated patient enrollment in the pivotal study RESMAIN of resminostat as maintenance therapy in patients with advanced-stage CTCL conducted in 11 European countries at more than 50 study centers.
Announced strong preclinical data on 4SC-202's potential in both monotherapy as well as in combination with checkpoint inhibitors.
Appointed Jason Loveridge, Ph.D., as Chief Executive Officer. Promoted Frank Hermann, M.D., to Chief Development Officer and Roland Baumgartner, Ph.D., to Chief Scientific Officer.
Established an international Scientific Expert Panel (iSEP) to provide 4SC with strategic counsel on research and clinical product development.
Sold operations of 4SC Discovery to BioNTech Small Molecules GmbH.
Sold the immunology portfolio to Immunic AG in exchange for a one-time upfront payment, milestone payments and royalties on sales.
Licensed 4SC-205 to Guangzhou LingSheng Pharma Tech Co., Ltd (Link Health) for development and marketing of 4SC-205 in China, Hong Kong, Taiwan and Macao in exchange for upfront and milestone payments totaling up to EUR76 million.
Business outlook for 2017
Continue enrolling patients in the pivotal study RESMAIN of resminostat in CTCL.
Define the optimal route forward for resminostat in HCC.
Initiate two Phase II studies of 4SC-202 in combination with checkpoint inhibitors.
Initiate formal preclinical development of 4SC-208.
Generate further out-licensing deals for non-core assets and continue evaluating potential partnering opportunities with pharmaceutical and biotech companies to progress the clinical development of 4SC's core pipeline assets.
Development of cash balance in full year 2016 and financial forecast
4SC's cash balance/funds amounted to EUR11,333 thousand as of 31 December 2016, compared with EUR22,794 thousand as of 31 December 2015. The decrease relates to an average monthly outflow of cash from operations of EUR827 thousand as well as to the repayment of a shareholder loan amounting to EUR1,500 thousand. 4SC currently estimates that the liquid funds earmarked for its financing will be sufficient for another twelve months.
4SC will host a public English-language conference call today at 3 p.m. CEDT (9 a.m. EDT), during which management will provide information on the material developments in full year 2016 and beyond.
+49 89 2030 35704 (Germany)
+44 330 336 9411 (United Kingdom)
+1 719 325 2385 (USA)
Conference ID: 8512846
Presentation material for the conference call is available at 4SC's website. After the event, a replay can be accessed from there as well.
Resminostat is an orally administered histone deacetylase (HDAC) inhibitor with an epigenetic mechanism of action that potentially offers a novel approach to treating a wide variety of cancers, both as monotherapy and - in particular - in combination therapy with other anti-cancer drugs. As an inhibitor that blocks HDAC classes I, IIB and IV, resminostat can potentially offer benefit to patients as it inhibits tumor growth and proliferation, causes tumor regression, and strengthens the body's own immune response to cancer.
Resminostat has been shown to be well tolerated in patients with advanced cancers in Phase I studies. Its use in the treatment of cutaneous T-cell lymphoma (CTCL), Hodgkin's lymphoma and liver, lung, colon, pancreatic and biliary tract cancers has been and is being investigated in further clinical studies. Initial positive efficacy results for resminostat have - amongst others - been observed in combination with the standard medication sorafenib in selected patients with advanced liver cancer (hepatocellular cancer, HCC).
4SC-202 is an orally administered small molecule for the treatment of cancer. 4SC-202 is an epigenetic modulator with a unique mechanism of action that inhibits both the lysine-specific demethylase (LSD1) protein and class I histone deacetylase proteins (HDAC 1, 2 and 3), which play significant roles in the regulation of signaling pathways in degenerated cancer cells.
4SC-202 has been investigated in a Phase I study with 24 intensively pretreated patients with several types of highly advanced hematologic cancers, and has proven to be tolerated. Positive signs of anti-tumor efficacy were observed with one complete remission for 28 months and one partial responder for 8 months.
Data from preclinical investigations showed that 4SC-202 strengthens the anti-tumor immune response. Treatment with 4SC-202 alters the tumor microenvironment and increases infiltration of immune cells into the tumor. In June 2016, Further preclinical investigations showed that the combination of 4SC-202 with checkpoint inhibitors resulted in better anti-tumor activity than treatment with checkpoint inhibitors alone, suggesting a very promising clinical development path for 4SC-202 in both refractory and non-responding patients to treatment with checkpoint inhibitors.
4SC-208 is a small molecule specifically targeting two kinases crucial for Hedgehog/GLI signaling, which is primarily controlled by epigenetic mechanisms. Inhibition of this signaling pathway has emerged as a highly effective strategy in obstructing the tumorigenic capacity of cancer stem cells, responsible for metastases and recurrence of tumors.
The Hedgehog/GLI signaling pathway is critical for tumor development, proliferation and survival. To date in the industry, clinically tested Hedgehog inhibitors target the Hedgehog pathway upstream of the transcription factor GLI at the level of the SMO protein. However, Hedgehog signaling in CSCs is mostly activated downstream at GLI level. 4SC-208 aims to inhibit at GLI level and thus potentially to overcome resistance to the Hedgehog inhibitors available so far.
4SC strongly believes that 4SC-208 is a promising drug candidate and intends to advance the compound into initial clinical studies in relevant cancer indications. Cancer indications that are particularly promising are those where resistance to therapies targeting the Hedgehog/GLI pathway is emerging.
4SC-208 was already examined in preclinical in vivo models to document the intended mode of action. As a next step, 4SC-208 will enter into regulatory preclinical testing in order to initiate Phase I clinical evaluation.
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 AG is a clinical-stage biopharmaceutical company developing small-molecule drugs that can target key indications in cancer with high unmet medical needs through epigenetic mechanisms. Such drugs are intended to provide patients with innovative treatment options that are more tolerable and efficacious than existing therapies and provide a better quality of life. Our core assets are resminostat, 4SC-202 and 4SC-208.
4SC's pipeline is protected by a comprehensive portfolio of patents and comprises promising products that are in various stages of preclinical and clinical development. 4SC's aim is to generate future growth and enhance its enterprise value by entering into partnerships with pharmaceutical and biotech companies and/or the eventual marketing and sales of approved drugs in select territories by 4SC itself. Founded in 1997, 4SC had 49 employees as of 31 December 2016. 4SC has been listed on the Prime Standard of the Frankfurt Stock Exchange since December 2005.