Q2 results on 11th October were in line with expectations, with cash at period-end of £20.9m and the Phase III trial of ridinilazole on track to report top-line data in H2 2021. As a reminder, the Phase III programme of ridinilazole comprises two global trials run broadly concurrently, each expected to recruit approx. 680 patients with CDI (confirmed by clinical symptoms and a positive CDI toxin test). The primary endpoint is the efficacy of ridinilazole (200mg twice a day) vs. vancomycin (125mg four times a day) as measured by sustained clinical response (the primary endpoint met in Phase II), in addition to which a number of health-economic parameters will be assessed to support market uptake post approval. We continue to expect filing of ridinilazole in 2022, and forecast a peak sales potential of >$300m in the US alone, with substantial upside from other major markets.
Companies: Summit Therapeutics
We have updated forecasts to reflect Summit’s plan to establish a direct sales team in the US for ridinilazole, currently in Phase III for the treatment of C. difficile infection (CDI). As a result, our intrinsic value estimate is upgraded to 66p/share (from 48p), with Summit’s growing portfolio of preclinical, new-mechanism antibiotics providing potentially substantial further upside. We reiterate our positive stance.
Today’s new data on DDS-04 (a series of antibiotics against Enterobacteriaceae, a group of pathogens classified as High-Priority by the WHO) confirms that the series represents a high-potential addition to Summit’s emerging pipeline of new-mechanism antibiotics. We look forward with interest to further developments, including the selection of a preclinical candidate, and reiterate our positive stance.
FY results highlight Summit’s advancing pipeline as a pure-play developer of new-mechanism antibiotics, Ridinilazole (targeting C. difficile infection, an area of unmet need due to high recurrence rates) recently entered Phase III trials, and we continue to expect SMT-571 (targeting N. gonorrhoeae infection, already on its last treatment option as a result of high and rising antibiotics resistance) to enter Phase I trials by year-end. In addition, encouraging development progress is being made on a number of earlier-stage programmes targeting hard-to-treat, priority pathogens (including gram negatives, which pose a particular healthcare threat). We reiterate our positive stance.
The subscription provides a welcome boost to Summit’s near-term plans to initiate Phase III trials for ridinilazole, the company’s novel treatment of C. difficile infection, in Q1 2019; and supports the completion of IND enabling studies for SMT-571 for the treatment of gonorrhoea, expected to enter Phase I trials in H2 2019. We reiterate our positive stance on Summit.
Bagir Group (BAGR LN) Interim results | M&C Saatchi (SAA LN) H1 outperformance provides a huge buffer against uncertainty | Summit Therapeutics (SUMM LN) H1’s highlight antibiotics programmes on track
Companies: BAGR SAA SUMM
ECO Animal Health Group (EAH LN) Margin beat drives EBITDA upgrade | Summit Therapeutics (SUMM LN) Microbiome preservation data on ridinilazole published in PLOS ONE | Verona Pharma (VRP LN) Conviction Opportunity in Pulmonary Disease
Companies: ECO Animal Health Group plc (EAH:LON)Summit Therapeutics (SUMM:LON)
Burford Capital (BUR LN) Petersen v Argentina positive developments | Low & Bonar (LWB LN) Tough H1 | ReNeuron Group (RENE LN) Exclusivity deal in ophthalmology, licensing deal expected in 2018 | Safestyle UK (SFE LN) Turnaround well underway but additional hit to profits and cash | Summit Therapeutics (SUMM LN) Grant award from CARB-X to support gonorrhoea programme | Swallowfield (SWL LN) Strong growth in Brands mitigates Manufacturing
Companies: BUR LWB RENE SFE SUMM BAR
Adept4 (AD4 LN) Satisfactory progress against key objectives for 2018 | Ergomed (ERGO LN) TU disappoints but medium-term outlook bright | Redde (REDD LN) In line FY update, no change to forecasts | Small-cap quantitative research Momentum screen refresh + 7 highlighted stocks | Summit Therapeutics (SUMM LN) PhaseOut DMD misses endpoint: ezutromid development terminated
Companies: CLCO ERGO SUMM
BCA Marketplace (BCA LN) Apax offer underplays the growth potential and forecast upside risk | Summit Therapeutics (SUMM LN) Second N. gonorrhoeae target identified |
Companies: BCA Marketplace (BCA:LON)Summit Therapeutics (SUMM:LON)
Amino Technologies (AMO LN) Full year expectations unchanged | Findel (FDL LN) Year of progress and delivery to instill confidence | Instem (INS LN) Contract win for Samarind RMS | Microsaic Systems (MSYS LN) Clear path to commercial success | Summit Therapeutics (SUMM LN) Q1 results: Phase II DMD trial on track for Q3 data release
Companies: AMO STU INS MSYS SUMM
Bioquell (BQE LN) In line trading despite FX headwinds | Carador Income Fund (CIFU LN) Significant reset activity post expiration of US risk retention appeal | Driver Group (DRV LN) Sale and leaseback in line with strategy | Harwood Wealth (HW LN) Acquires retirement solutions specialist Plan65 | Midatech Pharma (MTPH LN) FY results in line with expectations, US ops achieve EBITDA breakeven | River and Mercantile Group (RIV LN) AuM +1.1%, -5% EPS forecasts; resilience remains | Safestyle UK (SFE LN) New competitor impacts forecasts as we feared might be the case | Summit Therapeutics (SUMM LN) Further supportive data from PhaseOut DMD unveiled
Companies: BQE DRV HW/ SFE SUMM
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Although 2020 will probably go down in history as one of the most challenging years experienced during our lifetime, it will also likely be chronicled as one of the best years for the recognition and appreciation of science. As we entered 2020, the COVID-19 pandemic was in its infancy. However, it rapidly evolved through the exponential rise in infections and mortality globally. Much has been achieved during the past 12 months in the fight against COVID-19, but, as we enter 2021, there are considerable concerns about the emergence of a mutant version of the virus and the second wave that we are now facing.
Companies: AVO ARBB ARIX BBGI CLIG DNL FLTA ICGT OCI PCA PIN PHP RECI STX SCE TRX SHED VTA YEW
Q4 trading has led sales to guidance being raised 8%. This has been driven by better than expected UK sales, incl. success with new customers like Wilko/Tesco. Some of the benefit is offset by a non-cash FX debit, but it still leads to an upgrade and higher net cash. As a result of successful trials in Tesco Express, W7 is also being rolled out to 469 more stores. This, and previously announced distribution gains, bodes well for incremental sales/PBT in 2021, and underlines the appeal of its value-for-money brands. On 11x 2019 cash-adjusted EV/EBITDA, valuation is undemanding, particularly with the added attraction of dividends/income.
Companies: Warpaint London PLC
Foresight Group , the award-winning infrastructure and private equity investment manager to IPO on the Main Market (premium). The Offer will primarily comprise a sale of shares by existing shareholders (c.80% of the Offer) with a smaller offering of new shares (c.20% of the Offer) to be issued by the Company. Details TBA. Cornish Metals (TSX-V: CUSN) intends to list on AIM. The Company is proposing to raise £5 million by way of private placement of new Common Shares (the "Fundraising") to advance the United Downs copper-tin project. The Company expects that Admission will become effective in February 2021. The Company's Common Shares will continue to be listed and trade on the TSX-V in Canada. VH Global Sustainable Energy Opportunities plc, a closed-ended investment Company focused on making sustainable energy infrastructure investments, today announces intends to launch an initial public offering of shares on the Official List (Premium) of the Main Market of the London Stock Exchange. Due by Early Feb.
Companies: TYM W7L BEG CRPR EUZ IRR CMCL FARN KETL AUG
Ongoing strength in the key China market has prompted a positive trading update, indicating FY21 revenues and EBITDA will be significantly ahead of (already upgraded) expectations. Demand for Aivlosin in China in particular has remained strong throughout Q3 and is expected to remain so in Q4. We upgrade our FY21 revenue forecasts by 12% to £91.9m, which flows through to a 30% PBT upgrade to £10.1m. Whilst there is some caution expressed over the sustainability of this demand, we now forecast a flat performance YoY in FY22, but this is still 10% ahead of our previous estimates at the PBT level. The shares remain suspended pending the publication of the delayed FY20 results, which will be released as soon as possible alongside the H1’21 interims.
Companies: ECO Animal Health Group plc
Synairgen (SNG.L): Completion of recruitment for at home trial | Sensyne Health (SENS.L): Research agreement with The Royal Wolverhampton NHS Trust
Companies: Synairgen plc (SNG:LON)Sensyne Health Plc (SENS:LON)
After an eventful 2020, ReNeuron released updated 12-month Phase ll data in January on its lead human retinal progenitor cell (hRPC) project. This continues to show a consistent and robust, sustained average gain in visual acuity in retinitis pigmentosa (RP). A continuation study in nine patients using two million cells is underway with three- and six-month data due over H2 CY21 and the first three patients treated. This will facilitate partnering negotiations. A pivotal hRPC study may start in 2022. Deals are possible in CY21 on the exosome genetic drug delivery platform, which could be very valuable. The valuation remains at £190m with strong cash.
Companies: ReNeuron Group plc
Cambridge Cognition provided a positive FY 2020 trading update, with revenues (+34%), net losses and cash all ahead of expectations, and delivering an EBITDA-positive Q4. After a year of record order intake (£12.7m) and with a year-end order book of £11.2m (+96% on the prior year), the company is positioned to deliver another year of strong growth. This update provides further evidence of (i) the commercial focus that the CEO has instigated, (ii) the cross-selling opportunities for its newer digital solutions, and (iii) the prospect of a period of sustained strong growth in what are large (c.£1.2bn) and high growth (c.20%) addressable markets for digital solutions for clinical trials. We increase FY 2021 revenues by 18% to £8.5m, implying 26% growth and raise our target price 31% to 105p.
Companies: Cambridge Cognition Holdings Plc
Robust FY21 performance forecast, despite pandemic
Companies: SDI Group plc
Cambridge Cognition ("COG") has provided a trading update for the year ended 31 December 2020 that is ahead of our expectations. Group Revenues grew +34% to £6.7m (2019: £5.0m) and were +7% ahead of DCe of £6.3m. COG delivered significant revenue growth from digital solutions for clinical trials as it increased its focus on commercialisation. The strong beat in Revenue is due to an improved commercial execution across a wider portfolio of products as the Group has placed a key emphasis on crossselling CANTAB with newer electronic Clinical Outcome Assessment (eCOA) and digital solutions for frequent, remote testing of patients outside of the clinic setting. The Group's order intake for the year closed at a record £12.7m, up +158% on the previous year's order intake of £4.9m and maintaining the growth trajectory reported in the interim results. The Group experienced a mixed effect due to Covid-19 as some orders and revenue recognition was delayed in the year. However, the pandemic has provided an impetus for an industry shift towards evaluating virtual clinical trials, which opened new opportunities for the Group. We move our target price to 89p (from 80p).
ANGLE raised £19.6m (gross) to capitalise on the first-mover advantage that the FDA clearance for Parsortix will create, catalysing ANGLE’s ability to exploit the emerging multi-billion dollar liquid biopsy market. It will enable ANGLE to pursue multiple parallel revenue streams: (i) as a service provider to the pharma industry particularly looking to improve on immunotherapy patient outcomes (companion diagnostics) and (ii) to develop a number of specific clinical applications. Not only does it strengthen the balance sheet ahead of partner discussions but it provides the resources to develop in parallel relevant laboratory developed tests and fund the necessary clinical utility studies that will accelerate clinical adoption. We re-introduce forecasts and raise our target price to 150p (c.£310m EV), which is supported by risk-adjusted DCF and peer group analyses.
Companies: ANGLE plc
On 30th December 2020, RUA reported that shareholders had approved resolutions regarding the placing along with a strongly oversubscribed Open Offer. RUA now start 2021 with the resources and mandate to accelerate the development of its products, where we anticipate reports of progress during the year. We have slightly increased our R&D and CapEx spend for FY 2022 to reflect this investment and the cash utilization. RUA’s issued share capital now comprises 22,184,797 shares and the increases in FY 2022 investment in its products, modestly change our valuation by about £2.0m to £113.2m for the Company, equating to 510p per share.
Companies: RUA Life Sciences Plc
STX is a commercial-stage company delivering specialty products that address patients’ unmet medical needs, with an initial focus on treating iron deficiency (ID). Feraccru®/Accrufer® has been approved by the regulators in both Europe and the US. For various reasons, STX has been unable to secure a commercial partner for Accrufer in the US. Consequently, the board is now considering an STX-led launch option, thereby retaining all the US profits. Financial modelling shows the logic of this option, but it would necessitate financing the working capital requirements covering the next two years in the region of £25m-£30m.
Companies: Shield Therapeutics Plc
Ongoing strong demand for EKF’s products, both in the core business and the Primestore MTM Covid-19 sample collection device, means the FY20 outturn will be “comfortably ahead” of already upgraded expectations. This pattern is expected to persist throughout Q1’21 and beyond and management is confident that the performance in Q1 will be materially ahead of expectations. Having previously left FY21 estimates untouched, we are today putting through the first in what we expect to be a series of material upgrades. Given the dynamic situation around Covid-19, we expect regular updates throughout the course of the year and will adjust our forecasts accordingly as visibility over ordering patterns increases.
Companies: EKF Diagnostics Holdings plc
Novacyt Initiation of Coverage: Through the rapid commercialisation of a COVID-19 test, Novacyt has transformed its financial position. Demand for the Group's COVID-19 test and other COVID-19 reagents are expected to make up the majority of revenue generated until FY22E, whereupon the Group is looking to drive long-term growth across its business via the development of high-margin clinical diagnostics and establish itself as a leader in infectious disease testing.
Companies: Novacyt SAS
Interim results were in line with the 28 October trading update, reflecting the impact of the pandemic, with sales down 27% and LBITDA of £1.3m. However, c.10% LFL growth for Health & Nutrition (HN) in October and November is encouraging and points to long-term growth. Together with confirmation that first shipments against the initial 1m order for AbC-19 rapid antibody tests have taken place as well as first shipments of VISITECT CD4 Advanced Diseases tests to Africa, we expect a strong H2 (c.75% of FY sales), with potential upside driven by a currently poorly visible, yet anticipated long-term opportunity from its three key value drivers: Food Detective in China, VISITECT CD4 and COVID-19 lateral flow devices (LFDs). We leave our forecasts unchanged until we have further clarity on the unfolding COVID-19 opportunities. Whilst this implies c.£9.4m sales in H2, this is still eminently achievable given that supply has the ability to generate in excess of £9m of sales in Q4 FY 2021, should the demand materialise.
Companies: Omega Diagnostics Group PLC