Allergy Therapeutics (AGY.L): Initiation of field trial | Sensyne Health (SENS.L): Research agreement with Milton Keynes University Hospital
Companies: Allergy Therapeutics plc (AGY:LON)Sensyne Health Plc (SENS:LON)
Companies: BAYN BAYN BAYNEUR BAYN BAYN BYR BAYER BAY BAYZF BAYRY BAYNN BAYA AGY SENS
Allergy Therapeutics has announced the screening of the first patient in the G309 exploratory field study of Grass MATA MPL, a short course, aluminium-free, allergen-specific, subcutaneous immunotherapy (SCIT), in seasonal allergic rhinitis and/or rhinoconjunctivitis induced by grass pollen. G309 is a double-blind, placebo controlled, randomised study designed to evaluate the efficacy and safety of an optimized Phase III dose of 27,600 SU Grass MATA MPL. The trial will run for one year, capturing the 2020/21 allergy season, and recruit c 150 patients over 12 sites in Germany and the US. The primary endpoint is the combined symptom medication score (CSMS) averaged over the peak grass pollen season.
Companies: Allergy Therapeutics plc
Allergy Therapeutics delivered a solid 6% revenue growth for FY20 to £78.2m, from £73.7m, despite COVID-19 impacts taking a 2% toll. The well-established European commercial platform produced operating profit before R&D of £14.2m, from £11.3m, with R&D spend of £9.0m, from £13.2m. Pollinex Quattro Grass is set to start a pilot Phase III study before initiating full registration trials. The promising VLP-based peanut vaccine reported highly encouraging preclinical data which, if maintained, could be transformational for future prospects. The fruits of the development portfolio are expected to enable the market entry into the commercially attractive US. Cash resources of £37.0m are ample to fund near-term requirements. We initiate coverage with a £325m (51p a share) valuation.
Allergy Therapeutics (AGY): Corp FY 2020 – record pre-R&D EBIT | Amino Technologies (AMO): Corp Argentinian software contract win | ANGLE (AGL): Corp Peer reviewed publication, using Parsortix in MBC | Bigblu Broadband (BBB): Corp Quickline secures up to £6.1m of subsidy in Lincolnshire | Hardide (HDD): Corp Trading in line with a stronger Q1 expected | Trackwise Designs (TWD): Corp Interim results, new contracts boost confidence | Xeros (XSG): Corp Commercial progress tracking in line with expectations
Companies: AGY AMO AGL XSG TWD BBB HDD
Allergy Therapeutics reported full-year 2020 results that were marginally ahead of expectations, driven by lower overhead costs (COVID-related) and lower R&D. This underpinned 25% growth in pre-R&D EBIT to £14.2m on 7% CER revenue growth and continued, albeit smaller, market share gains. Year-end net cash was £33.2m, providing the company with the financial resources to execute on current research programmes. The outlook remains characterised by the start of the Phase III Grass MATA MPL trial in US/Europe, enhanced by a broadening pipeline of opportunities and continued commercial traction in core European markets. We have made small upward adjustments to our forecasts and raise our target price to 45p, which is underpinned by the current commercial operations, with potential upside in Grass MATA MPL in the US (c.21p on risk-adjusted DCF), Polyvac peanut vaccine and the recently broadened VLP technology licence.
Umuthi Healthcare Solutions Plc, the technology led healthcare business focused on the distribution of pharmaceuticals and the provision of medical facilities in remote areas, seeking admission to the Standard Listing segment of the Official List
The Hut Group. Expected intention to float on the Main Market. THG is a vertically integrated digital-first consumer brands group, retailing its own brands in beauty and nutrition plus third party brands, via its proprietary technology platform to an online and global customer base. For the year ended 31 December 2019, THG's revenue was £1.1 billion, up 24.5 per cent. year-on-year, and its Adjusted EBITDA was £111.3 million, representing an Adjusted EBITDA margin of 9.8 per cent . The Company has experienced an acceleration in growth during 2020, with revenue of £676 million, up 35.8 per cent. on the equivalent prior year period , achieved in the 6 months to 30 June 2020, which the Directors believe evidenced the non-discretionary nature of the nutrition and beauty categories .
Kibo Energy PLC, the multi-asset Africa focused energy company, is seeking admission for its 100% owned UK subsidiary Sloane Developments Ltd , which will be renamed Mast Energy Developments PLC (MED), to the Standard List of the London Stock Exchange plc . Targeted for Q4 2020. The MED business strategy is to acquire and develop a portfolio of flexible small-scale power generation assets, exploiting a growth niche market in the UK for Reserve Power generation to balance out the national grid at critical times.
Companies: JET2 KRPZ IRON DNL RBG MPAC AGY SENS TGP
Omega Diagnostics (ODX.L): Group performs CE-marking of Mologic Ltd’s COVID-19 antibody test | Diurnal (DNL.L): Distribution agreements for Europe | Allergy Therapeutics (AGY.L): Licence agreement to secure new vaccine technology
Companies: ODX DNL AGY
Allergy Therapeutics (AGY): Corp Broadening and deepening VLP vaccine pipeline | IQGeo Group (IQG): Corp US telecoms network contract win | Omega Diagnostics (ODX): Corp Mologic COVID-19 test CE Marked | President Energy (PPC): Corp Off to a flying start
Companies: AGY ODX PPC IQG
For this Monthly, we are delighted that Rooney Nimmo and 24Haymarket have allowed us to reproduce a recent report they jointly published, entitled An analysis of UK exits (2015-2019), which provides a granular analysis by sector of the activity in our dynamic private companies world. We hope you find the insights of interest.
Companies: AVO AGY ARBB ARIX CLIG ICGT NSF PCA PIN PXC PHP RECI SCE TRX SHED VTA
AGY is a long-established specialist in the prevention, diagnosis and treatment of allergies. Pollinex Quattro (PQ) is an ultra-short-course subcutaneous allergy immunotherapy (SCIT) platform, which continues to make strong market share gains in a competitive environment. Several products using the PQ platform are in late-stage development in order to move them to full registration under new EU and US regulations. Another reassuring trading update states that the company has hit new records and has the resources in place to fund its pending R&D investment programme required to get its products approved by the regulators.
Allergy Therapeutics (AGY.L): FY20 Trading Update | N4 Pharma (N4P.L): Change of adviser
Companies: Allergy Therapeutics plc (AGY:LON)N4 Pharma Plc (N4P:LON)
Allergy Therapeutics (AGY): Corp | Arcontech (ARC): Corp
Companies: Allergy Therapeutics plc (AGY:LON)Arcontech Group PLC (ARC:LON)
Allergy Therapeutics released a further positive trading update to that of 24 June, citing full-year revenues of £78.2m (+7% CER), above-market earnings and year-end cash of £37.0m (c.£5.4m higher than forecast). With confirmation that June was also a ‘normal’ month, albeit in the seasonally weaker second half, this should provide greater comfort to investors as we enter FY 2021, still with some uncertainty over the potential for second waves to disrupt patient visits. We make only minor changes to forecasts to reflect actual revenues and year-end cash in FY 2020 as well as small changes to FY 2021, but this is the third positive trading update since the interims. We reiterate our target price of 40p, which excludes any value attributed to early pipeline products and US market entry.
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Venture Life has developed significant momentum through 2020, reflected in the strong share performance over the year. Building on this momentum, the company has announced it is conditionally raising £34m via an equity raise to help it secure additional M&A opportunities. At this time, Venture Life has identified three opportunities, which we estimate could deliver significant earnings accretion if all are completed. We have updated our forecasts to reflect the raise but at this time have left our underlying assumptions unchanged. We expect Venture Life to maintain the momentum it has developed, supported by the proposed raise and M&A opportunities; we re-iterate our Buy recommendation.
Companies: Venture Life Group 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
ReNeuron, a UK-based stem-cell therapy developer, has announced today a fundraising of up to £17.5m (gross) through the means of a placing, subscription and open offer. The Company has also announced its FY’21E interim results as well as the latest data from its lead candidate hRPC in the ongoing Phase I/IIa clinical trial for Retinitis Pigmentosa (RP). The additional funding aims to provide liquidity for the next 18 months, and through key clinical development milestones for the hRPC programme and exosome collaborations. **** As joint broker to ReNeuron, we are restricted and can therefore provide factual comment only. Shareholder approval for the transaction will be sought at the General Meeting to be held on the 11th December 2020 ****
Companies: ReNeuron Group plc
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.
ReNeuron Group (RENE.L): Interim results
Venture Life aims to become a global leader in the self-care branded product market, where there are a number of structural growth drivers. It has a unique and scalable platform to develop, manufacture and distribute products, including its own brands and international customers’ brands. What is already a high margin business is poised to deliver a compelling mixture of top line growth with significant operating leverage. Performance in H1 (EBITDA +347%) highlights the potency of VLG’s model. Acquisitions can also leverage the platform to drive growth, and management has a very strong track record here. On top of this exciting growth play, there is also a chance that its Dentyl dual-action mouthwash could have applications to slow/reduce CV19 transmission, adding to the upside potential.
President Trump likes to project himself as a highly successful businessman, but surprisingly little is known about his true financial position. Various articles, including a 2016 in-depth analysis by The Wall Street Journal, have speculated about his income and asset base. All sorts of claims and counter-claims have been made about his wealth – by Trump himself, pitching his fortune at some $9bn, and by journalist Timothy O'Brien, suggesting that it is as “low” as $150m-$250m. It is doubtful whether we shall ever know the truth, but we can use Trump’s UK corporate filings to gain an insight into his businesses in Scotland.
Companies: AVO ARBB ARIX CLIG DNL FLTA ICGT PCA PIN PHP RECI STX SCE TRX SHED VTA YEW
EKF has confirmed it expects a strong Q4 from both the core business and ongoing demand for the Primestore MTM sample collection device. As a result, FY20 performance is now expected to comfortably exceed market expectations, which have already been upgraded several times through the year. We upgrade our FY20 EBITDA forecasts by a further 6% to £24.4m and look forward to further updates in due course. EKF is a Best Idea for 2020 and we expect strong momentum to continue.
Companies: EKF Diagnostics Holdings plc
FAB is a specialised Contract Research Organisation operating in monoclonal antibody engineering and production and supply. The company generated a 9% increase in H121 revenue driven by core antibody engineering expertise and demand for supply services. FAB’s trusted reputation, the continuing significance of antibodies for therapies and diagnostics, and operational continuity adjustments, together created encouraging resilience to the pandemic’s impact. The pace of progress in developing its differentiated Mammalian antibody library, OptiMALTM, translates into a commercial launch target in FY22.
Companies: Fusion Antibodies Plc
In the positive trading update today, ReNeuron announced that patient dosing has commenced in the US in the expanded Phase IIa clinical trial for the lead hRPC candidate for Retinitis Pigmentosa (RP). We are pleased to see the trial is under away given the backdrop, and we expect data from the expanded cohort over the next 12 months. This data alongside previously announced highly positive hRPC data aims to be sufficient for ReNeuron to seek regulatory approval in H2 2021 to commence a single pivotal clinical study programme (i.e. potentially one trial off regulatory approval). A milestone that could pave the way for licensing agreements. We continue to believe the hRPC programme is highly novel programme that is differentiated against peers, and we forecast peak global sales potential of £880m. We also note that ReNeuron has signed its fourth research evaluation agreement with a leading biotech to evaluate the use of ReNeuron’s exosomes for the delivery of novel therapeutics. Whilst these deals are initial modest, they aim to produce proof-of-concept data that could pave the way to more lucrative licensing agreements for the exosome technology. Lastly, after the retirement of John Berriman, it was announced that Dr Tim Corn will become Chairman heading a significantly leaner Board. We make no forecast changes and reiterate our intrinsic value implied from our valuation analysis of 177p/share.
Full-year results for the year to 30 June were in line with the 10 July trading update, with FY 2020 revenues of £1.1m (-55%) with an adjusted pre-tax loss of £6.5m (-18%) and year-end cash of £8.2m (+134%). They reflect a year which brought notable challenges, but also significant opportunities, which genedrive has responded to. While regulatory delays have thus far prevented material revenues from COVID-19 testing, they have the potential to be transformational in FY 2021. GDR confirmed that it is in advanced negotiations to sole supply a MoH in Europe, which could be worth low double-digit millions of pounds. Whilst we have reduced our FY 2021 revenue forecast (£2.7m to £1.8m, -33%), this excludes any revenues from the high-throughput SARS-CoV-2 test, or the POC test, as modelling their impact is not possible at the moment, which leaves significant room for upside. We leave our target price under review.
Companies: Genedrive Plc
RUA have announced an earlier than expected update on the testing of its Elast-Eon-coated tri-leaflet artificial heart valve from its pilot pulsatile flow program. This testing is meant to simulate not just the flow of blood through the valve, but the viscous patterns that occur during the opening and closing of the valve, in the simulation of typical natural conditions. Not only have the minimum ISO Standard performance requirements been easily surpassed, but there were indications of reproducibility and ease of manufacture.
Companies: RUA Life Sciences Plc
Venture Life Group has reported on a very strong H1/20A period. Revenues were up 80% with operational leverage delivering c100% growth in gross profit and +350% adjusted EBITDA growth. Performance was supported by the acquisition of PharmaSource, strong sales to China, sales of new brand, DISINPLUS, and the group's ability to maintain production at its Italian manufacturing facility. With this report we have introduced FY21E forecasts, expecting the company to maintain its growth momentum and deliver 10% revenue growth. Venture Life is delivering a strong performance, we maintain our Buy recommendation.
4D pharma has announced a merger with the Longevity Acquisition Corporation (NASDAQ: LOAC), a Special Purpose Acquisition Company that provides a NASDAQ listing and $14.6m (gross) of cash for 4D pharma shareholders. The statement notes that this additional capital is expected to extend the current operational runway another 6 months into early Q3 2021 (vs. Q1 2021 previously) providing capital to support the ongoing clinical development of its pipeline. 4D pharma will maintain its AIM listing and will remain headquartered in the UK. The merger was agreed at an valuation of £1.10 per 4D pharma ordinary share, representing a 18% premium to last night’s close of £0.93. Post-completion, 4D pharma will issue approx. 19,783,827 new ordinary shares, and 4D pharma shareholders will own approx. 86.9% of the issued share capital of the enlarged group. The merger is expected to become effective in early 2021, subject to shareholder meetings for both companies, and approval of all necessary US / SEC documentation
Companies: 4d Pharma PLC
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.