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4SC AG. (3/21/18). "Press Release: 4SC AG Announces Results for Financial Year 2017". Planegg-Martinsried.

Organisations Organisation 4SC AG (FSE: VSC)
  Group 4SC (Group)
  Organisation 2 Yakult Honsha Co., Ltd.
  Group Yakult Honsha (Group)
Products Product resminostat (4SC-201)
  Product 2 domatinostat (4SC-202)
Index term Index term 4SC–SEVERAL: investment, 201706–201707 cash capital increase €41m with 11.68m new shares at €3.5/share
Person Person Loveridge, Jason (4SC 201609– CEO)

Conference call scheduled for today, 21 March 2017, at 3:00 pm CET (10 am EDT)

4SC AG (4SC, FSE Prime Standard: VSC) today published the financial results for the financial year ended 31 December 2017 that presents all material reporting period developments and provides an outlook for 2018. The full report is available at 4SC’s website.

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, 4SC-202 and 4SC-208. We expanded our senior leadership team and are now well resourced to further advance our products in clinical development and toward market approval.

We look forward to 2018 as a year in which we can make significant progress at 4SC. We will continue patient enrollment in our RESMAIN pivotal study of resminostat in cutaneous T-cell lymphoma (CTCL). We continue to expect to publish top-line results in the first half of 2019 and, if positive, plan to submit resminostat for market approval in Europe and potentially the U.S. If approved, resminostat would be the first histone deacetylase inhibitor approved for CTCL in Europe and the first and only drug approved for maintenance therapy in this indication in either Europe or the U.S.

We expect top-line results from the first cohorts of patients from our Phase Ib/II study SENSITIZE of 4SC-202 in combination with the checkpoint inhibitor pembrolizumab in melanoma in the second half of 2018. In a second Phase II study EMERGE, 4SC-202 will also be evaluated in combination with another checkpoint inhibitor for treating gastrointestinal tumors. In this case, we expect safety data in the late 2018. Taking data from these two studies, we will aim to initiate a pivotal clinical trial with 4SC-202 as soon as possible thereafter in the rare skin cancer Merkel-cell carcinoma (MCC).

Throughout 2018 and beyond, we also expect to make significant progress and further enhance the value of 4SC through completion of formal preclinical development of 4SC-208 and to initiate a Phase I/II clinical study thereafter, and through out-licensing deals of non-core assets.”

Key highlights of 2017 and 2018 YTD

> Defined new strategic plan and communicated it to the market.

> Raised gross €41 million from successful capital increase, current operations now funded into 2020.

> Recruited one third of patients for pivotal RESMAIN study of resminostat in CTCL followed by positive interim safety data review.

> Initiated Phase Ib/II study SENSITIZE of 4SC-202 in combination with pembrolizumab in melanoma.

> Started formal preclinical testing for 4SC-208 and secured fundamental composition of matter patent for the substance in the U.S. and further geographic regions.

> Entered into new licensing agreements with partners for non-core assets and received upfront and milestone payments from such agreements.

Business outlook for 2018

> Continue enrolling patients in the pivotal RESMAIN study of resminostat in CTCL.

> Yakult Honsha, 4SC’s development partner for resminostat in Japan, to start a Phase II study of resminostat in biliary tract cancer in H1 2018.

> Top-line results from the first cohorts of patients in the Phase Ib/II study SENSITIZE of 4SC-202 in combination with pembrolizumab in melanoma to be available in H2 2018. Study expected to complete in H1 2019.

> Phase II study EMERGE of 4SC-202 in combination with avelumab in gastrointestinal tumors to start in H1 2018. Safety data expected in H2 2018 and top-line results in H2 2019.

> Data from preclinical studies of 4SC-202 in combination with other drugs expected to be published at relevant conferences in 2018. Additional clinical studies utilizing 4SC-202 in combination with other drugs in collaboration with collaborators expected to start in late 2018.

> Complete formal preclinical development of 4SC-208.

> Generate further out-licensing deals 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 2017 and financial forecast

4SC generated gross proceeds of circa €41 million from the cash capital increase completed successfully at the beginning of the third quarter of 2017. 4SC’s cash balance/funds were at €41,327 thousand on 31 December 2017, compared with €11,333 thousand as of 31 December 2016. The average monthly operating cash burn rate in 2017 was €723 thousand, which is 28% below the level of €1,000 and €1,400 thousand forecast in the previous half-year’s report. The discrepancy in the forecast is largely due to the deferral of clinical expenses for the RESMAIN and SENTISIZE studies into 2018. For 2018, 4SC is expecting an average monthly use of cash from operations of between €1,800 thousand and €2,000 thousand. Considering the current financial planning and the intended operating activities, the Management Board estimates that the funds realized from the Company’s financing in 2017 should be sufficient to finance 4SC into 2020.

Conference call

4SC will host a conference call today at 3 pm CET (10 am EDT) to inform about important developments in the reporting period and beyond.

Investors, financial analysts, and journalists interested in participating in the conference call can access via the following telephone numbers:
Phone Numbers: +49 (0)69 2222 2018 (Germany)
+44 (0)330 336 9411 (United Kingdom)
+1 646-828-8156 (USA)
Conference ID: 2623906

A presentation document supporting the conference call will be available at 4SC’s website. After the event, a replay can be accessed from there as well.

About 4SC

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 currently comprises three key drug candidates in various stages of preclinical and clinical development: resminostat, 4SC-202 and 4SC-208.

4SC aims 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.

4SC is headquartered in Planegg-Martinsried near Munich, Germany. The Company had 48 employees as of 31 December 2017 and is listed on the Prime Standard of the Frankfurt Stock Exchange (FSE Prime Standard: VSC; ISIN: DE000A14KL72).

About resminostat

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 immune response to cancer.

Resminostat has been shown to be well tolerated in several clinical trials. Resminostat is currently being investigated in a pivotal study in cutaneous T-cell lymphoma (CTCL) by 4SC. A Phase II study in biliary tract cancer is planned by 4SC’s development partner Yakult Honsha in Japan. Amongst others, resminostat has previously been investigated in biliary tract or pancreatic cancer and hepatocellular carcinoma (HCC).

About 4SC-202

4SC-202 is an orally administered small molecule with a unique mode of action that was designed to strengthen the body’s own anti-tumor immune response, open the tumor microenvironment and encourage infiltration of immune cells into the tumor.

4SC-202 has been investigated in a Phase I study with 24 heavily pretreated patients with several types of highly advanced hematologic cancers, and was proven to be well tolerated. Positive signs of anti-tumor efficacy were observed with one complete remission (28 months) and one partial responder (8 months).

In addition to its therapeutic potential in cancer monotherapy, 4SC is evaluating 4SC-202’s capacity as a partner in combination therapies, specifically in the immuno-oncology area. In this respect, 4SC initiated a Phase Ib/II study of 4SC-202 in combination with the anti-PD-1 checkpoint inhibitor pembrolizumab in patients with advanced-stage melanoma. A second Phase II study of 4SC-202 in combination with the anti-PD-L1 checkpoint inhibitor avelumab, which will be conducted by an academic partner in gastrointestinal cancers, is expected to start soon.

As soon as results from the aforementioned trials will be available, 4SC plans to advance 4SC-202 into a pivotal study in combination with a checkpoint inhibitor in PD-(L)1 refractory patients with advanced Merkel cell carcinoma (MCC).

About 4SC-208

Data from several preclinical studies in well recognized in vivo models has established the efficacy of 4SC-208 in inhibiting the Hedgehog/GLI signaling. Inhibition of this signaling pathway is emerging 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 all target the pathway upstream of the transcription factor GLI, whereas 4SC-208 inhibits several kinases associated with 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 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.

Forward-looking information

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.

Record changed: 2019-06-09


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