Companies: Synairgen plc
Oxford University and AstraZeneca announced the first interim analysis from the Phase III study of its COVID-19 vaccine candidate, which was found to be 70% effective in preventing COVID-19. This follows similar announcements from Moderna, and Pfizer/BioNTech in the previous two weeks, and the caveats we mentioned at the time remain the same. While all of these results have been highly encouraging, we reiterate that they do not diminish the urgent need for COVID-19 treatments and testing, which will be required for years to come. We consider Synairgen, Avacta, genedrive, Omega Diagnostics and Open Orphan to offer good buying opportunities.
Companies: AVCT ODX SNG GDR ORPH
Moderna announced the first interim analysis from the Phase III study of its COVID-19 vaccine candidate, which was found to be c.95% effective in preventing symptomatic COVID-19 disease. This follows a similar announcement from Pfizer/BioNTech last week, and the caveats we mentioned at that time remain the same. AstraZeneca-Oxford University are also due to announce initial results this month. While these results are highly encouraging, we reiterate that they do not diminish the urgent need for COVID-19 treatments and testing, which will still be required for years to come, and we outline why. We consider Synairgen, Avacta, genedrive, Omega Diagnostics and Open Orphan to offer good buying opportunities.
Pfizer and BioNTech announced the first interim analysis from the Phase III study of its COVID-19 vaccine candidate, which was found to be >90% effective in preventing COVID-19. While the results are very promising, we believe there was a large over-reaction in the market in response to the news. It should not have been unexpected – we hoped for positive results from vaccine manufacturers this month, and we hope there is more to come, as AstraZeneca-Oxford University and Moderna are also due to announce initial results this month, and overall there are 11 vaccines in Phase III testing. However, these early results do not diminish the urgent need for COVID-19 treatments and testing, which will still be required for years to come, and we outline why. We consider the price falls to stocks such as Synairgen (-39%), Avacta (-36%), genedrive (-38%), Omega Diagnostics (-25%) and Open Orphan (-9%) to offer good buying opportunities.
Synairgen has raised £80m to fund a Phase III trial for SNG001 in COVID-19 disease, which is due to commence in Q4 2020 and will be run globally by Parexel, with results expected in Q2 2021, and scale up manufacturing. This follows a successful pre-IND meeting with the FDA, which provided the guidance to commence such a study. Assuming that this trial replicates the results seen in the 100-patient Phase II trial, we would expect Emergency Use Approval (EUA) to follow shortly thereafter. Meanwhile, the Managed Access Programme (MAP) in the UK and Europe, run by Clinigen, could generate early commercial revenues. We have made adjustments to forecasts to reflect these costs and raise our SOTP rNPV target price to 420p, which could rise further should stockpiling orders be received.
Chariot Oil & Gas (CHAR): Corp | dotDigital (DOTD): Corp | Gateley (GTLY): Corp | Iofina (IOF): Corp | Synairgen (SNG): Corp | Universe Group (UNG): Corp
Companies: CHAR DOTD IOF SNG UNG GTLY
Synairgen reported interim results to 30 June in which the adjusted net loss was £3.9m with period-end cash of £10.9m. A fuller analysis and disclosure of the Phase II trial of inhaled interferon (SNG001) in hospitalised COVID-19 patients confirms the earlier optimism we had at the time of its first headline disclosure in July. The announcement that Clinigen is to launch a Managed Access Program (MAP) in the UK and Europe for SNG001 is a significant step enabling treatment of hospitalised COVID-19 patients under certain circumstances ahead of regulatory approval. With plans to scale manufacturing to c.100,000 treatment courses per month in 2021, Synairgen is clear in its ambitions. Based on pricing points for Rebif and Avonex and Gilead’s remdesivir, future supplies suggest significant potential revenues in 2021. We leave forecasts unchanged for the time being until we have greater visibility over the uptake of the MAP as well as the regulatory path. We reiterate our price target of 360p.
Avingtrans (AVG): Corp | Chariot Oil & Gas (CHAR): Corp | dotDigital (DOTD): Corp | Gateley (GTLY): Corp | Iofina (IOF): Corp | Synairgen (SNG): Corp | Universe Group (UNG): Corp
Companies: AVG CHAR DOTD IOF SNG UNG GTLY
Synairgen (SNG.L): Positive interim data from trial of SNG001 in COPD patients | Silence Therapeutics (SLN.L): R&D Update | Verona Pharma plc (AIM: VRP.L): Initation of pilot study in COVID-19 patients
Companies: Synairgen plc (SNG:LON)Silence Therapeutics plc (SLN:LON)
Alumasc (ALU): Corp | Bigblu Broadband (BBB): Corp | Flowtech Fluidpower (FLO): Corp | STM (STM): Corp | Synairgen (SNG): Corp
Companies: ALU FLO STM SNG BBB
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Robust FY21 performance forecast, despite pandemic
Companies: SDI Group 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
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
For many reasons, 2020 was a transformational year for Circassia as the new management team set to work streamlining the business, addressing legacy issues and positioning the group to benefit from the strong market position of NIOX, a gold standard diagnostic device for asthma. Whilst the pandemic has had an impact, recovery is underway, with Q4 revenues back to 86% of Q1 levels. The EBITDA breakeven point of the business has been reduced further to £32.0m and there was £7.4m of net cash on the balance sheet at the year end. Whilst the pace of recovery remains difficult to predict, the business looks well set for the medium term.
Companies: Circassia Group PLC
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
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
Allergy Therapeutics’ European commercial business remains resilient despite COVID-19 impacts. The H121 trading statement indicates sales growth of 7% (+5% CER), while steady pipeline progress is also being made. Recruitment and treatment in the G309 Grass MATA MPL Phase III study is on track, with post period key events including initiation of the P001 ex vivo peanut allergy biomarker study and publication of positive challenge chamber results for ImmunoBON in a peer reviewed journal. This bodes well for news flow delivery over the rest of calendar 2021. G309 results in the autumn are expected to inform design of the G306 pivotal grass trial; P001 data in the spring will support IND submission; and ImmunoBON is set to launch in Germany later this month. A record cash balance of £48m (at end-December 2020) covers nearterm requirements taking the company through to material value-inflection points. Ahead of H121 results on March 3, we maintain our £325m (51p/share) valuation.
Companies: Allergy Therapeutics 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
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).
A year in which we expect the company to make significant advancements in the development and commercialisaon of LIGHT, AVO kicked off 2021 with a new financing partnership with specialist asset financing company DiamedCare and technical updates. With its differenated technical and commercialsoluon supported by growing clinical evidence base for proton therapy ("PT"), AVO remains well posioned to disrupt the radiotherapy market. We expect further progress in 2021 to connue to de-risk the AVO story, with much of the risk now lying on commercial execuon, in our view. Part of AVO's turnkey PT soluon, the new lessor financing agreement with DiamedCare covering Europe and the US should facilitate faster adopon in smaller radiotherapy centers which currently represent an underserved and largely untapped market. We maintain and reiterate both our OUTPERFORM recommendaon and 135 GBp target price.
Companies: Advanced Oncotherapy Plc
ReNeuron’s Dec’20 £17.5m raise now means the Group is sufficiently funded through key upcoming milestones for its lead hRPC candidate and the exosome platform – mitigating a previous pivotal issue. 2021 could promise to be the critical year for the Group, with the potential to unlock value from its programmes well beyond its current modest market value. We refresh our forecasts post yesterday’s analyst briefing, and reiterate our positive stance.
The six-month trading update to 31 December demonstrates solid underlying growth, with revenues rising 7% to £54.0m, or c.5% at constant exchange rates (CER), despite ongoing COVID-19 restrictions. Period-end cash was £48.3m, which implied a c.30% increase (+£11.3m) in underlying cashflows in the period. With relevant and potentially significant commercial and regulatory newsflow through 2021, we expect the shares to perform well. We leave our forecasts unchanged for FY 2021 at this point and reiterate our 45p target price, pointing out the substantial and unwarranted discount to its nearest peer (ALK-abello - 6.1x EV/Sales). This target also excludes the value for US market entry for Grass MATA MPL or its early-stage pipeline, including VLP Peanut allergy vaccine.
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
Alcon, a dominant force in the $25bn ophthalmology space, is set to outgrow the industry in the mid-term – driven by the pick-up in demand for recently-launched products, PanOptix and Precision1. Moreover, with robust margin expansion potential – led by an improving product mix and targeted cost-savings – earnings should grow healthily. A sturdy balance sheet increases its appeal further. Interestingly, Alcon is recovering faster than rivals from the COVID-19-hiccups and its sales and profitability profile should inflect once the situation normalises. Add.
Companies: Alcon, Inc.