4SC provides Q2 and 6M 2017 update
Conference call scheduled for today, 10 August 2017, 2 pm CEDT (8 am EDT)
Planegg-Martinsried, Germany, 10 August 2017 – 4SC AG (4SC, FSE Prime Standard: VSC) today published its Consolidated Half-Year Financial Report and provided a business update for the six months ended 30 June 2017 as well as the Company’s current outlook. The full report is available for download on 4SC’s webpage.
Jason Loveridge, Ph.D., CEO of 4SC, commented:
“With the conclusion of a successful capital increase generating gross proceeds of ca. EUR 41 million we are now well positioned to reach our main goal over the next few years: to create significant value for our shareholders by executing on accelerated routes to market for our core cancer products resminostat, 4SC-202 and 4SC-208.
We will continue to enroll patients in our pivotal RESMAIN study of resminostat in cutaneous T‑cell lymphoma (CTCL) and anticipate initiating two clinical studies of 4SC-202 in combination with checkpoint inhibitors in the second half of 2017. Furthermore, we will continue formal preclinical development of 4SC-208 in order to initiate Phase I clinical evaluation.
Finally, we aim to continue to enhance the value of 4SC and to add to our funds through signing deals with the right industry partners to pursue further development of our non-core assets as we did with the Kv1.3 inhibitors which we recently licensed to Maruho.”
Key highlights of Q2 2017 and beyond
- EUR 41 million secured from successful capital increase; proceeds forecast to be sufficient to finance 4SC’s accelerated development strategy into 2020
- Preclinical inhibitors of the Kv1.3 ion channel out-licensed to Maruho Co., Ltd. in return for up to EUR 208 million in upfront, development and commercial milestones plus single-digit royalties
- Patient enrollment and opening of study centers well on track for the ongoing pivotal RESMAIN study, which examines the potential of resminostat as maintenance therapy in patients with advanced CTCL
- US composition of matter patent secured for structurally related compounds including 4SC-208; preclinical testing started
Business outlook for 2017
- Initiate two Phase II studies of 4SC-202 in combination with checkpoint inhibitors in H2 2017; 4SC’s SENSITIZE study in patients with advanced melanoma (skin cancer) refractory to treatment with checkpoint inhibitors; investigator-initiated EMERGE study in patients with microsatellite-stable gastrointestinal tumors
- Continue patient enrollment in the pivotal RESMAIN study of resminostat in CTCL
- Continue preclinical testing of 4SC-208 to initiate aPhase I clinical study immediately thereafter
- Pursue further 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
Cash balance development in H1 2017 and financial forecast
4SC’s cash balance/funds amounted to EUR 4,638 thousand as of 30 June 2017, compared with EUR 11,333 thousand as of 31 December 2016. The decrease relates to an average monthly outflow of cash from operations of EUR 902 thousand compared to an average monthly outflow of EUR 1,243 thousand in H1 2016.
Taking into account the proceeds from the July 2017 cash capital increase in the gross amount of ca. EUR 41 million as well as current financial planning and the intended operating activities, the Management Board of 4SC narrows its financial forecast for the full year 2017 of an average monthly use of cash from operations from EUR 600 to EUR 1,400 thousand to between EUR 1,000 and EUR 1,400 thousand. The Management Board further estimates that available cash/funds should be sufficient to finance the Company into 2020.
4SC will host a public English-language conference call today at 2 pm CEDT (8 am EDT), during which the management will provide information on the material developments in H1 2017 and beyond.
|Phone Numbers:||+49 89 2030 35709 (Germany)|
|+44 330 336 9105 (United Kingdom)|
|+1 719 325 4756 (USA)|
A presentation document supporting the conference call is available at 4SC’s website. After the event, a replay can be accessed from there as well.
18 July 2017, 4SC licenses Kv1.3 inhibitors to Maruho
Resminostat is orally administered and potentially offers a novel approach to treating a wide variety of cancers, both as monotherapy and in combination therapy with other anti-cancer drugs. Resminostat 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 in monotherapy were observed in patients with Hodgkin’s lymphoma and in combination with sorafenib in selected patients with advanced liver cancer (hepatocellular cancer, HCC).
4SC-202 is an orally administered small molecule for the treatment of cancer with a unique mode of action that inhibits both class I histone deacetylase proteins and the lysine-specific demethylase protein, which play significant roles in the regulation of signaling pathways in cancer cells.
4SC-202 has been investigated in a Phase I study with 24 mostly heavily 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 demonstrated that 4SC-202 strengthens the anti-tumor immune response, alters the tumor microenvironment and increases infiltration of immune cells into the tumor. 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.
Data from several preclinical in vivo models has established the efficacy of 4SC-208 in inhibiting the Hedgehog/GLI signaling. Inhibition of this signaling pathway has emerged as a highly effective strategy in obstructing the tumorigenic capacity of cancer stem cells, as well as tumor development, proliferation and survival.
Available inhibitors of Hedgehog signaling target the pathway upstream of the transcription factor GLI, whereas 4SC-208 inhibits at the level of GLI and is thus potentially able to avoid the tumor recurrence and relapse observed in response to currently available inhibitors.
4SC believes that 4SC-208 is a promising drug candidate and expects it to complete formal preclinical testing in 2018 and to enter into a Phase I/II clinical study immediately thereafter. Cancer indications that are particularly promising are those where resistance to therapies targeting the Hedgehog/GLI pathway are emerging, such as in basal cell carcinoma.
4SC AG is a clinical-stage biopharmaceutical company developing small-molecule drugs that can target key indications in cancer with high unmet medical needs. 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. 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 core assets include resminostat, 4SC-202 and 4SC-208.
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 45 employees as of 30 June 2017. 4SC has been listed on the Prime Standard of the Frankfurt Stock Exchange since December 2005.
Information set forth in this press release contains forward-looking statements, which involve risks and uncertainties. The forward-looking statements contained herein represent the judgement of 4SC as of the date of this press release. 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.