Research, Charts & Company Announcements
Research Tree provides access to ongoing research coverage, media content and regulatory news on 4Sc. We currently have 23 research reports from 3 professional analysts.
The cancer burden is growing globally. Each year >18 million people are diagnosed, nearly 10 million die and the estimated economic cost exceeds $1 trillion. From early diagnosis to late-stage disease, cancer care often involves inappropriate or unnecessary interventions that drive costs but provide limited clinical benefit. Coupled with an increased understanding of cancer biology and rapid technological advances, this has been driving momentum for precision medicine, leading to patient and societal benefits. The use of biomarkers and sophisticated diagnostics is facilitating early intervention through robot-enabled minimally invasive surgery and locally delivered radiotherapy. Immuno-oncology has revolutionised cancer care, with the focus now on identifying combinations that further improve long-term outcomes. Liquid biopsies and companion diagnostics are increasingly being used to personalise therapy.
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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 €30.8m at end-Q318, which should fund operations into 2020. Our valuation is virtually unchanged at €328m or €10.7/share.
We have recently carried out a review of our Corporate Sponsored Research Coverage. Following this review we have decided to terminate 4SC AG's formal agreement and to discontinue research coverage of 4SC AG with immediate effect.
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).
4SC's H1/2018A report published today indicates that the company remains on track, but is fundamentally undervalued. As detailed in our note of the 16th July, financed into 2020E, the company's current valuation is largely justified by its pivotal stage resminostat ("RESMAIN") programme. It takes little or no account of the potential value of the domatinostat currently in Phase II in combination with the immune checkpoint inhibitor ("ICI") pembrolizumab for melanoma. First interim data from the domatinostat ("SENSITIZE") trial due in H1 should provide a substantial catalyst for the stock now trading at less than half of its early 2018 peak. Preclinical studies and positive data from sub-optimally dosed drugs of the same class support a synergy between immune checkpoint inhibitors ("ICI") and domatinostat. We maintain and reiterate both our OUTPERFORM recommendation and TP of €10.
With the share price down over half from it's early 2018 peak, 4SC's valuation looks justified on the basis of it pivotal resminostat programme alone. The market ascribes little value to the immunotherapy combination programme with dominatostat now in Phase II. Although sentiment toward immuotherapy has deteriorated in the wake of the negative Incyte-Merck epacadostat ("IDO-1") data, we contend the dominatostatpembrolizumab ("pembro") immunotherapy combo still holds promise. Preclinical studies and data from sub-optimally dosed drugs of the same class support a synergy between immune checkpoint inhibitors ("ICI") and dominatostat. Interim data expected from the dominatostat-pembro phase II ("SENSITIZE") melanoma study in H2/2018E could provide a substantial catalyst for the stock. We reiterate our OUTPERFORM recommendation and our target price of €10.
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.
4SC's Japanese partner Yakult Honsha's (Yakult) decision to join the RESMAIN study looks a significant endorsement of the resminostat programme. While CTCL (Cutaneous T-Cell Lymphoma) is probably not itself a substantial opportunity in Japan, with Yakult's prime focus on the more Asian-prevalent biliary cancer, it clearly demonstrates commitment from a partner that already knows the product well. Outside Japan, prospects for 4SC also look bright. Its clinical programmes appear to be progressing well. Strong news flow, including the first read out from its proof-ofconcept phase II for 4SC-202 in H2/2018E, should maintain momentum for the stock over the next 6 months and beyond. Adding in the potential upside from Yakult in Japan and the expected news flow, we reiterate our OUTPERFORM recommendation and increase our target price to €10 (from €7.50).
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 €349m or €11.4/share (€11.3/share previously).
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 €347m or €11.3/share (€344m previously).
4SC announced today that the scheduled Data Safety Monitoring Board ("DSMB") had identified no safety concerns with the on-going RESMAIN pivotal trial Cutaneous TCell Lymphoma ("CTCL") and recommended the study should continue as planned. With top-line data from RESMAIN for resminostat and first interim data from SENSITIZE for 4SC-202 in melanoma expected in H1/2019 and H2/2018 respectively, there is plenty to drive value over the next 6-18 months. We reiterate our OUTPERFORM recommendation and a fair value of €7.50 / share potentially rising to over €10 / share with expected news flow from the pipeline as well as non-core assets over the next 6 to 12 months.
With a pipeline based on sound proof-of-principle, 4SC is building an independent strategy focussed on orphan drugs with best-in-class blockbusters exploited through major partners. The company's lead product resminostat is in a pivotal trial as a much needed maintenance therapy in the orphan CTCL (Cutaneous T-Cell Lymphoma). Class I HDACi (Histone Deacetylase inhibitors) are showing real promise in combination with the new wave of immuno-therapeutics. Entering phase II in combination with an approved checkpoint inhibitor in melanoma, the safety and efficacy of the Class I HDACi 4SC-202 provide the hallmarks of a best-in-class blockbuster as well as providing a snug fit into the company's orphan strategy. We initiate with an OUTPERFORM recommendation and a fair value of €7.50 / share potentially rising to over €10 / share with expected newsflow from the pipeline as well as non-core assets over the next 6 to 12 months.
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.
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.
Research Tree provides access to ongoing research coverage, media content and regulatory news on 4Sc. We currently have 23 research reports from 3 professional analysts.
Bioventix delivered a strong set of interims, with revenues up 21%. Given the 9% decline in operating expenses, this resulted in a 31% increase in adjusted EBITDA, with adjusted pre-tax profit also rising 31% to £4.4m (52% of full-year forecasts) and adjusted EPS up 29% to 69.4p. An interim dividend of 36p was declared (+20%) with net cash at period end of £5.5m. Growth was driven by both Vitamin D antibody sales/royalties (+c.25%), its portfolio of other antibodies (+c.12%) and a more meaningful contribution from troponin. Given the inevitable disruption that COVID-19 will have to some testing volumes (although tests such as NTproBNP are likely to benefit from high risk COVID patients), we leave forecasts unchanged, confident that the strong H1 and weaker sterling in H2 should offset any potential H2 trading shortfall. We leave our forecasts unchanged and reiterate our 3750p target price. At this level, the stock would trade on a 30x FY 2020 P/E with a free cashflow yield of 3.1x
ReNeuron has provided an update in light of the Covid-19 pandemic. Current day-to-day disruption has been minimised. However, ReNeuron did flag likely delays to its two ongoing clinical studies for Stroke Disability and Retinitis Pigmentosa (RP) and when top-line data will be made available. We believe this delay risk is more pertinent in the Stroke programme, given the RP trial is not enrolling patients at this point awaiting the approval of clinical trial protocol adjustments (including approval to enrol an additional 9 patients). We previously expected additional Phase I/IIa data for RP in H2 2020 and interim results of the Phase IIb Stroke trial in mid-2021, and the company will provide further guidance on the timing of interim data from the studies in due course. The Fosun Pharma collaboration remains on track with initial focus on the Stroke programme, for which clinical trial applications have been filed to open clinical sites in China. This may help offset any possible disruption to the Stroke programme patient enrolment at US and UK clinical sites. Lastly, in an intriguing development, ReNeuron has initiated a research project exploring the use of its exosomes as a delivery vehicle for viral vaccines to increase the potency of Covid-19 vaccines in development. The project is understood to be at an early stage but could accelerate quickly in the current regulatory climate, and possibly lead to commercial partnering opportunities and upside not reflected in our forecasts.
Companies: Reneuron Group
Futura has released its 2019 preliminary results this morning, updating the market after a very busy 12 months with its all important FM57 study delivering exciting and commercially relevant data in December. On this front management is hosting a webcast presentation that will be available on the company website later this morning to provide more colour on the study.
Companies: Futura Medical
Avacta announced that it is raising £2m by way of a subscription for 11.1m ordinary shares at 18p (follows £9m raise in October 2019 at 15p per share), subject to a general meeting. Given the current economic uncertainty and disruption caused by the coronavirus outbreak, we think this is prudent as it extends the cash runway further into 2021. Not only does this create a cash buffer for any unseen disruption, but it also provides additional time to advance its immunotherapy pipeline with partners (fully funded by the partners), as well as delivering further commercial progress for both therapeutics and diagnostics. Avacta confirmed that it will file a CTA application as soon as possible, seeking the UK regulator’s permission to commence a Phase I safety study for its lead drug candidate (AVA6000 – pro-doxorubicin). This is on track to start in late 2020, having made good progress in manufacturing drug product. We retain a target price of 76p.
Companies: Avacta Group
Novacyt S.A* (NCYT.L): COVID-19 test update | Redx Pharma (REDX.L): Short term loan agreement
Companies: Novacyt Redx Pharma
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SDI was selected in finnCap’s Slide Rule QVGM+ top 30 stocks in Q1 2020, reflecting the projected strong sales and EPS growth over the next two financial years of 30% and 31% respectively, buoyed by recent acquisitions but more importantly the rising ROCE. The prospect of sustainable organic growth is considered likely for this buy-and-build model given ongoing investment to support portfolio companies’ ambitions. These quality metrics are also seen in Judges Scientific (a larger buy-and build investment story), which despite three-year 9% EPS CAGR, trades on a FY 2020 P/E of c.25x and FCF yield of 4.2%. Given the successful acquisition and integration of 11 businesses over the past six years, and mindful of opportunities that still exist for SDI, we are raising our target price to 105p, which brings the valuation into line with Judges. This implies FY 2021 EV/EBIT and P/E multiples of 19.6x and 24.5x, respectively.
Companies: Scientific Digital Imaging
Revenue growth of 10% in H2 brought FY results in line and the company was looking well set for strong progress in FY20. However, Covid-19 presents a significant short term challenge, given SUN’s focus on elective surgeries. The Board has moved quickly to enact cash preserving and cost saving measures, whilst continuing to supply essential products. Cash on the balance sheet and support from the group’s bankers provides short term liquidity and other indications of financial support are being actively considered.
Companies: Surgical Innovations Group
In an important step for Medicare coverage determination, Renalytix has been granted a Medicare Provider Transaction Access Number (PTAN) for its Salt Lake City Utah clinical laboratory. This effectively means Renalytix is now qualified as a billable provider and can initiate a ‘Local Coverage Determination’ process to establish US national Medicare coverage and reimbursement for KidneyIntelX testing. Medicare and Medicaid insurance programmes are estimated to represent 50-60% of chronic kidney disease patients likely to benefit from KidneyIntelX. Medicare coverage determination expected by calendar H1 2021 is not presently reflected in our current forecasts and remains a substantial value creation event if achieved. Over the last week we also saw impressive healthcare economic data published by Boston Healthcare supporting KidneyIntelX use in large healthcare systems, and Renalytix AI also featured in N+1 Singer’s Stocks in Unprecedented Times – Part 2 handbook.
Companies: Renalytix AI
Much of the UK’s privatisation programme took place between the early 1980s and the mid-1990s: subsequent sales have been few. Undoubtedly, privatisation attracted many private investors to the market, many for the first time.
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Omega Diagnostics provided a trading update for FY 2020 that is broadly in line with expectations, confirming also that it had received Chinese approval for the laboratory version of the Food Detective Test that we had expected in January. Under the current circumstances of an almost global lockdown due to coronavirus, we consider this to be a positive outcome. First shipments of VISITECT CD4 (both 350 and Advanced Disease tests) were also confirmed (albeit lower than forecast due to delays in Nigeria and as a result of the coronavirus outbreak), but are expected to be deferred into FY 2021. We have made minor forecasts changes to FY 2020 but leave FY 2021 and our target price unchanged.
Companies: Omega Diagnostics Group
Following continued delays of a Brexit agreement, few sectors within the UK market have remained attractive to investors despite low valuations. One sector which has continued to outperform despite the political drama has been the UK video gaming sector (henceforth UK gaming), which we are fans of. We believe a combination of sector-leading growth, strong cash conversion and timely cyclical positioning support our positive view on the UK video gaming sector.
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IXICO has reported a strong financial performance for FY19A built on continued commercial focus and a strengthened organisation. Revenues of £7.6m were up 40% and gross margin was up 600bps versus FY18A and the company delivered its first year of profitability since IPO. EBITDA of £0.5m was strongly ahead of our forecast (+£0.1m) and delivered an EBITDA margin of 6%. We have maintained our revenue growth expectations of 20% for FY20E and FY21E but have upgraded our profit expectations given the strong reported performance. We maintain our Buy recommendation.
OptiBiotix ("OPTI") has had a strong start to 2020, with partners Agropur (US), Holland & Barrett (UK) and most recently Alfasigma (Italy) launching new products containing the company's microbiome-modulating functional ingredients. As an increasing number of products move to market, we remain positive as to the commercial potential of OPTI's functional ingredients as consumer awareness grows. The recent launches indicate growing momentum into 2020, when we expect existing agreements to start delivering substantial revenue streams and further demand for OPTI's products. We reiterate both our OUTPERFORM recommendation and 97p target price, based on our view that OPTI is at the beginning of a long-term revenue growth cycle.
Companies: Optibiotix Health
With the moratorium on publishing audited preliminary results in place, EKF has instead provided a comprehensive trading update with headline FY19 financials and an update on the outlook, including regarding the potential impact of Covid-19. In short, no impact has been seen to date and, whilst ordering patterns may experience some short term disruption, the testing of vulnerable groups such as Diabetes and Anaemia patients is more important than ever. Added to that, EKF has recently entered into a contract manufacturing agreement to produce sample collection tubes for Covid-19 testing in the US, with initial orders of $1m expected to grow significantly in the coming weeks. At the very least, this should compensate for any short term hiatus in ordering patterns in the core business. Net cash of £14.3m gives a substantial financial buffer and news the board still intends to pay a maiden dividend of 1p (>5% yield) is a strong signal of confidence. In short, we remain extremely confident in EKF’s business model and prospects.
Companies: EKF Diagnostics Holding