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Becoming a dermato-oncology expert

Outlook | Pharmaceuticals & healthcare | 30 Oct 2017

4SC's new core strategy revealed earlier this year has focused on dermato-oncological indications, while its assets for other indications are partnered. The sharp focus will allow 4SC to become an expert in the field and to accumulate commercial know-how, as the company intends to market the core assets (resminostat, 4SC-202 and 4SC-208) in orphan indications on its own. A successful fund-raise in July means that the company now has sufficient funds until 2020 and past several important R&D events. We have overhauled our model to reflect 4SC's new strategy and our new valuation is €344m or €11.2/share.


Increased focus on core business

Update | Pharmaceuticals & healthcare | 19 May 2016

4SC's Q1 results highlight an increased focus on its core business of epigenetic research and commercialisation, resulting from the sale of the operational assets (for €650k in proceeds) of its discovery and collaborative segment, 4SC Discovery. 2016 is an important year for 4SC with expected newsflow from its clinical pipeline including the launch of its potentially pivotal EU Phase II study with resminostat in Cutaneous T-cell lymphoma (CTCL) and expected Phase II Japanese trial data in HCC and NSCLC (from partner Yakult).


Domatinostat programme to deliver Phase II data

Update | Pharmaceuticals & healthcare | 31 Jan 2019

4SC has reported progress with both its clinical-stage assets – resminostat, a broad spectrum HDAC inhibitor, and domatinostat, a specific Class 1 HDAC inhibitor. In January 2019, the investigator-led Phase II EMERGE study was initiated, which is testing domatinostat in gastrointestinal cancer. 4SC has developed a broad development programme for this drug, which will include several strategic options to commercialize the asset including out-licensing based on data from multiple Phase II studies and internal pivotal development for Merkel cell carcinoma. In January 2019, the resminostat RESMAIN study received a second positive DSMB safety review and the top-line results are expected in H120. 4SC remains well funded with cash of EUR 30.8m at end-Q318, which should fund operations into 2020. Our valuation is virtually unchanged at EUR 328m or EUR 10.7/share.


Domatinostat R&D ramp-up in H218

Update | Pharmaceuticals & healthcare | 17 Aug 2018

During the Q218 results call, 4SC management announced that with current funds, it plans to initiate some of its additional domatinostat trials including the pivotal Merkel-cell carcinoma (MCC) study and a Phase II skin cancer checkpoint combination study. 4SC will provide further detail in H218. The SENSITIZE study (Phase Ib/II, melanoma) is on track in Europe (data H119), while a new IND will allow expansion of the study into the US in 2019. The EMERGE study (Phase II, GI cancers) is now expected to initiate in Q318 (previously H118). The multiple domatinostat studies in H218/H119 will provide several R&D catalysts while investors wait for pivotal RESMAIN study data. Enrolment for the RESMAIN study (CTCL) continues in Europe and Japan (100/150 patients by end-2018), and top-line data are now expected in H219 (previously H119). Due to this modest delay, we now forecast resminostat launch in 2021 (previously 2020), and therefore slightly lower our valuation to €327m or €10.7/share (vs €11.4/share).


Yakult starts Phase II trial; fresh 4SC-202 data

Update | Pharmaceuticals & healthcare | 03 May 2018

Yakult, 4SC's development partner for resminostat in Japan, has reached two clinical development milestones. First, just two weeks after it joined 4SC's pivotal RESMAIN study (n=150) in CTCL, the company recruited the first patient in Japan. Top-line results from the RESMAIN trial are expected in mid-2019. In addition, Yakult initiated its own Phase II study in biliary tract cancer (n=100) in combination with S-1 chemotherapy. S-1 is widely used in Japan and other Asian countries to treat patients following relapse after a 1st line chemotherapy regimen. The final data readout is expected in mid-2020. Meanwhile, at the AACR Annual Meeting in April, 4SC presented new preclinical data supporting the use of its second lead product, 4SC-202 in combination with various immunotherapy agents. Our valuation is virtually unchanged at €348 or €11.4/share.


Yakult joined the pivotal RESMAIN study

Update | Pharmaceuticals & healthcare | 28 Mar 2018

Together with its Q417 results announced last week, 4SC also reported progress with its R&D activities. All three lead assets – resminostat, 4SC-202 and 4SC-208 – remain on course to be developed for specialty dermato-oncological indications. New details include an update on the 4SC-202 development plan and the news that 4SC’s Japanese partner, Yakult Honsha, joined 4SC’s pivotal resminostat study and will enrol patients in Japan. Our valuation is largely unchanged at EUR 349m or EUR 11.4/share (EUR 11.3/share previously).


Steady R&D newsflow

Update | Pharmaceuticals & healthcare | 09 Feb 2018

Over the past several months 4SC has reported progress with both its clinical-stage assets – resminostat and 4SC-202. The pivotal trial with resminostat as a maintenance therapy in advanced CTCL passed the first DSMB review and is on track to report data in H119. The Phase Ib/II study with 4SC-202 for melanoma has been initiated, while another Phase II study with 4SC-202 for GI cancer should start in Q118. 4SC-208 completes the core portfolio and is expected to enter the clinic in early 2019. Our valuation is largely unchanged at EUR 347m or EUR 11.3/share (EUR 344m previously).


Executive interview - 4SC

Edison TV: | Pharmaceuticals & healthcare | 10 Aug 2017

4SC is a Munich-based cancer biopharmaceutical company. In this interview Jason Loveridge, CEO of 4SC, provides an overview of the company, its recent equity capital raise (€41m gross) and its updated and progressive development plan.


Intention to raise equity to progress development

Update | Pharmaceuticals & healthcare | 17 May 2017

4SC has announced an updated development programme, to be funded by an equity fund-raising, which we expect in 2017. The proceeds from this will be used to accelerate development of 4SC's leading drug candidates. This will include continuing to progress resminostat in CTCL (initiated at end 2016), a subsequent filing of a marketing authorisation application in Europe (2019) and progression of resminostat into a further pivotal study in HCC (2018). 4SC also expects a pivotal study in 4SC-202 in Merkel cell carcinoma (2018) and the progression of 4SC-208 into clinical evaluation (early 2019). Our forecasts and valuation are under review. We believe that if 4SC executes the proposed plans it could be a significant and positive step.


A streamlined focus moving forward

Update | Pharmaceuticals & healthcare | 30 Mar 2017

2016 was an important year for 4SC as it launched its potentially pivotal Phase II study with resminostat, an epigenetic cancer drug, in CTCL. In addition, it announced positive subgroup analysis of a Phase II study in HCC with its partner Yakult. It is streamlining its focus on three core assets: resminostat, 4SC-202 (initiating Phase II trials in 2017) and 4SC-208 (initiating preclinical development). We have slightly increased our rNPV to €124m, but note that we forecast a cash horizon to end 2017/early 2018.


First patient enrolled in pivotal RESMAIN study

Update | Pharmaceuticals & healthcare | 19 Dec 2016

4SC has announced the enrolment of the first patient in its RESMAIN study. This is a pivotal study to evaluate resminostat (RES), an epigenetic cancer drug for maintenance treatment (MAIN) in patients with advanced-stage cutaneous T-cell lymphoma (CTCL). We expect early data to be reported in 2019. We increase our rNPV to EUR 120m from EUR 117m as we have raised the probability of the CTCL programme in Europe to 30% (from 20%) following the initiation of the trial.


Positive detailed analysis of Phase II trial data

QuickView | Pharmaceuticals & healthcare | 09 Nov 2016

4SC has announced positive Phase II results from a more detailed analysis of the HCC Yakult Phase II trial data, which we believe could lead to further clinical development. It has also recently announced the sale of its immunology portfolio (Vidofludimus and a cytokine inhibitor), which further streamlines the company's focus on its core business of epigenetics while retaining potential upside (via milestones and royalties). We increase our rNPV to €117m from €110m to reflect the increase in the potential of resminostat development in Japan.