Verona Pharma is delisting and cancelling its Ordinary shares from trading on AIM. It is consolidating trading on the NASDAQ market where it will retain its listing of American Depositary Shares (ADSs) under the ticker symbol VRNA. No general meeting is required to complete the AIM Delisting, which is expected to occur market close 29 October 2020. Each ADS represents eight Ordinary shares and are denominated in $. As per the company’s website, there are three options available now for VRP Ordin
Companies: Verona Pharma plc Sponsored ADR
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: SNG SLN VRNA
Fusion Antibodies (FAB.L): FY20 Results | Verona Pharma plc (AIM: VRP.L): Second part of Phase 2 trial of ensifentrine in COPD commences
Companies: Fusion Antibodies Plc (FAB:LON)Verona Pharma plc Sponsored ADR (VRNA:NAS)
There were few surprises in today’s H1 2020 results, and Verona has performed financially in line with our expectations. The main news is it has FDA permission to investigate ensifentrine in a study for hospitalised Covid-19 patients that is set to begin in Q3 2020. The study will provide clinical information on ensifentrine in a new disease beyond COPD and cystic fibrosis, and that could be leveraged within the regulatory package for COPD or licensing agreements. We note the recognition of a co
Verona has successfully completed a $200m (gross) raise via a private placement and subscription performed in the US. This is a significant milestone for the company providing funding to support the Phase III development of ensifentrine in COPD patients and addresses a key pivotal issue of financing clinical development. Net proceeds of approx. $183m are expected to fund operations into 2023 and is above our previously modelled minimum capital requirement ($130m). We continue to anticipate the P
Ensifentrine is Phase III-ready asset targeting a vast market of underserved COPD patients, and we believe the company offers one of the best opportunities for investors in the UK Biotech space. We have high conviction on ensifentrine as an effective and safe potential therapy for COPD, and believe the current Phase III trial design gives a reasonable and achievable route to US regulatory approval. We update forecasts to reflect the upside upon success, and assume short-term funding of $130m is
Verona Pharma’s investor and R&D webinar yesterday was an excellent example of the unmet need for a novel therapy in the 1.2m COPD patients that remain symptomatic despite maximum therapy. The event focused on the problems and opportunities arising from COPD, and brought together a group of leading pulmonologists representing the clinical community for a panel discussion (see below for key KOL takeaways). The event reinforced our confidence that ensifentrine has an important role as a solution t
Based on the FDA’s positive feedback, we believe the Phase III ENHANCE trial design (as detailed below) gives a reasonable and achievable path for regulatory approval for use in symptomatic COPD patients as a maintenance therapy. The decision to evaluate ensifentrine as a monotherapy and as an add-on to a single standard-of-care bronchodilator treatment (LAMA or LABA) is logical, and allows for a broad label. We note that ensifentrine has demonstrated clinically meaningful and statistically sign
Today’s Q1 update is broadly in line with our expectations, the company awaits End-of-Phase II feedback from the FDA this quarter to inform the design of a pivotal Phase III programme for nebulized ensifentrine in COPD. This FDA feedback will now be a written response, rather than through a meeting, due to the Covid-19 pandemic. We continue to expect the initiation of this Phase III programme in Q3 2020 (subject to funding and Covid-19 lockdown measures). Ensifentrine remains a highly compelling
Today’s Phase II single-dose (Part A) data on the metered dose inhaler (MDI) formulation of ensifentrine in COPD patients are strong, demonstrating a statistically significant and clinically meaningful, dose-response improvement in lung function vs. placebo. This improvement was statistically significant in all doses vs. placebo, except at the lowest strength. Furthermore, this lung function improvement showed statistically significant dose-response durability over 4 hours and 12 hours. Whilst i
Inspecs, a UK designer, manufacturer and distributor of eyewear frames to global retail chains announces its intention to IPO onto AIM raising £94m with a market cap of £138m. Admission expected 27th February. FY Dec 2018 numbers show revenue of $57m and underlying EBITDA of $11m
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Verona Pharma has announced senior management changes with Dr. David Zaccardelli replacing Dr. Jan-Anders Karlsson as CEO, effective immediately, and Mark Hahn replacing Piers Morgan as CFO. In our view, the new US-based management, who join as a proven team, are solid appointments with strong CVs and a history of successfully working together. Most recently at Dova Pharmaceuticals until its $915m acquisition by Swedish Orphan Biovitrum (Sobi) in November 2019, and together have raised over $600
Today’s Phase IIb trial results investigating nebulized ensifentrine as a twice-daily add-on to a long-acting antimuscarinic bronchodilator (LAMA) in symptomatic patients with moderate-to-severe chronic obstructive pulmonary disease (COPD) are excellent and highly supportive of the overall drug’s profile. In the study, ensifentrine met its primary endpoint (peak FEV1 at week 4) for all doses, showing a dose-responsive statistically significant and clinically meaningful improvement of lung functi
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Full-year results were in line with the trading update of 21 July, with revenues of £31m (-2%), reflecting the impact of COVID-19 on out-patient procedure rates, resulting in 14% and 24% declines in adjusted EBITDA and pre-tax profit, respectively. Lower than expected procedure growth rates and the decision to discontinue non-core (non-chlorine dioxide products) reduces forecast revenues by c.£3m to £33m in FY 2022. However, higher gross profit and tight control of costs (+6%) results in an unch
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Devolver Digital to join AIM, an award-winning digital video games publisher and developer in the indie games space. Recently awarded indie 'Publisher of the Year 2021' by GamesIndustry.biz. Offer TBA. Due early Nov.
Life Science REIT to join AIM raising up to £100m. This will be the first London listed real estate investment trust (REIT) focused on UK life science properties providing investors with exposure
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Cambria Autos has left the AIM following a takeover.
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Light Science Tech Holdings, the controlled environment agriculture technology and contract electronics manufacturing Group to join AIM. Raising £5m. Expected mkt cap £17.4m. Due 15 Oct.
Harmony Energy Income Trust to join the Specialist Fund Segment of the Main Market raising up to £230m. The Company's investment objective is to provide investors with an attractive and susta
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IXICO has provided an upgraded trading statement for FY21E following its previous update in August 2021. Revenues are now expected to be £9.2m (vs £8.7m previously), broadly in line with FY20A, which we see as a strong result given the pandemic and Huntington's Disease (HD) trials de-scope. EBITDA is expected to be materially ahead of FY20A's £1.3m, supported by strong Q4/21 trading, cost control and positive one-offs. The company has ended FY21 with a strong order book (£18.8m) and cash positio
Companies: IXICO Plc
CareTech is a specialist social care and educational services provider. This morning, the group has announced an update for the year to 30 September pointing to the fact that results will be in line with market expectations. The net debt position of £259m illustrates a further reduction since the end of H1 (31 March £263.1m) and implying a reduction to 2.7x adjusted EBITDA. During the year, seven new developments have opened, with a further eight properties purchased in H2. The group's freehold
Companies: CareTech Holdings PLC
SkinBioTherapeutics has announced it will launch its lead commercial product, AxisBiotix-Ps on World Psoriasis Day, 29 October 2021. To support the launch, the company has begun to receive, and store finished product in the Netherlands (close to its manufacturing partner) ahead of initial launches in the UK and US. Clearly the launch of its first product is a significant step for SkinBioTherapeutics, marking the transition from development company to commercial operation. We are encouraged by th
Companies: SkinBioTherapeutics Plc
Today’s prelims are in line with management’s expectations with losses before tax in the period of £30.3m (vs. £29.4m prior year). Post-merger, 4D pharma is clearly a different beast with access to the largest global capital market for Pharma/Biotech, and supported by £25.2m (net) proceeds from corporate activity. The company has cash runway until Q2 2022 and is well placed to successfully execute its clinical development strategy with multiple shots on goal. Primary focus is on MRx0518 with two
Companies: 4d Pharma PLC
Exactly one year ago, the FTSE 100 closed at 5,862, having fallen 100 points on the day, the lowest point since mid-May 2020, due in part, to the strength of sterling vs US$ at $1.34. One year on, the FTSE 100 has risen to 7,119, a rise of 21%, it remains 7% below the peak in January 2020. From an international viewpoint, US and European markets continue to trade at record highs. The US Federal Reserve is close to withdrawing some of its economic support this year as inflation picks up and the e
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Synairgen reported interim results to 30 June in which the adjusted net loss was £32.8m with period-end cash of £46.2m. Substantial pre-commercial progress and manufacturing activities have made in the half, although slower country approvals for trial sites will result in Phase III data readout slipping into Q1 2022. With increasing evidence of the need for a broad-spectrum antiviral delivered to the lungs and recognition that vaccines don’t provide complete protection against hospitalisations d
Companies: Synairgen plc
ANGLE reported an adjusted net loss of £7.2m (+58% vs. -£3.2m), with establishment revenues increasing 26% to £0.3m and costs rising 48% to £8.9m, reflecting the costs of opening its pharma services business and clinical laboratories in the US and UK. Net cash at 30 June was £21.0m, with a further £18.9m (net) placing proceeds after period-end. Evidence of momentum building within pharma services, backed by confirmation of three contract wins and multiple ongoing discussions (some of which are w
Companies: ANGLE plc
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Conduity Capital has left AIM.
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Softline the global solutions and services provider in digital transformation and cybersecurity, with its headquarters in London, is considering proceeding with a potential initial public offering of global depositary receipts representing its ordinary shares. The Company is considering applying for admission of the GDRs to the standard listing segm
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TMT Acquisition (TMTA.L) has joined the Main Market (Standard) pursue opportunities to acquire businesses in the technology, media and telecom sector. Raised £5m, mkt cap £5.5m.
NMCN Plc has left the Main Market (Premium) following the appointment of administrators.
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Harmony Energy Income Trust to join the Specialist Fund Segment of the Main Market raising up to £230m. The Company's investment objective is to provide investors with an attractive
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The current situation in the CDMO arena looks a bit like an arms race and Lonza seems to have firm plans to be part of it. The recently updated mid-term guidance is the explanation to do so, in our view. Management is strongly dedicated to staying with the extraordinary high EBITDA margin for the coming years.
Lonza’s hybrid investors day was well attended in Zurich, in which we participated.
Companies: Lonza Group (LONN:VTX)Lonza Group AG (LONN:SWX)
The positive market research results for Eroxon®, released this morning, provides further support for the company’s ongoing partnering efforts. We continue to believe that MED2002 is a differentiated product with significant potential in both prescription and OTC markets, and look forward to further PK data followed by Phase III start in H1 2018.
Companies: Futura Medical plc