ReNeuron Group (RENE.L): Interim results
Companies: ReNeuron Group plc
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 ****
IQ-AI (IQAI.L): Launch of IB Trax technology | ReNeuron Group (RENE.L): AGM Trading Update
Companies: IQ-AI Limited (IQAI:LON)ReNeuron Group plc (RENE:LON)
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.
ReNeuron has refocussed onto its human retinal progenitor cell (hRPC) as shown in the last business update and in the FY20 results. hRPC, now the lead project, show a consistent and robust sustained averaged response at the one million cell dose. The next dose level, two million cells in nine patients, could start this autumn. A pivotal study could be initiated in 2022. ReNeuron is starting to create multiple partnering opportunities from its core technologies. We have revised our valuation to £170m from £107m.
ReNeuron is a developer of stem cell therapies, with its lead human retinal progenitor cells (hRPC) candidate undergoing a Phase IIa study for the rare and progressive eye disease, Retinitis Pigmentosa (RP). In this note, we make forecast changes in response to the company’s strategic shift, cover recent competitor data for RP, and provide details on the exosome platform. Our valuation analysis has refocused solely on the hRPC programme, and implies an intrinsic value of 177p/share (vs. 310p/share).
AEX Gold (AEXG.L) has joined AIM alongside a £42.5m placing at 45p. Mkt Cap £79.7m. The Company, led by CEO Eldur Ólafsson, has established the largest land package of gold assets in Greenland with a current portfolio of licences covering 3,356 square kilometres, in the two known gold belts in Southern Greenland, the Nanortalik and Tartoq gold belts. Nalunaq is a high-grade gold asset with an updated Inferred Mineral Resource covering 422,770 tonnes at 18.5 grams per tonne of gold, or 250,970 ounces of gold, which covers the area in and around the historical mine. AEX has an existing listing on the TSX Venture Exchange
Companies: PYC THR PVR GDP YOU BBB MRL ONC RENE
Synairgen (SNG.L): Positive results from trial of SNG001 in hospitalised COVID-19 patients | ANGLE plc (AGL.L): Study published by University of Southern California | ReNeuron Group (RENE.L): Preliminary results
Companies: SNG AGL RENE
ReNeuron has announced its FY’20 prelim results for the 12-month period ending 31 March 2020. In the period, Revenue & other income for the period was £6.1m (vs. £0.0 in September 2019), principally made up of £6.0m received from Fosun Pharma as an initial gross license fee. We expect smaller milestones payments from Fosun Pharma in FY’21 and FY’22. R&D expenditure of £16.3m (vs. £16.2m prior year; vs. historic N+1 Singer estimate of £21.5m last published 29th June 2020) is lower than anticipated primarily related to the slower recruitment of the Stroke trial and the Covid-19 disruption to clinical trials previously flagged in April. Operating losses was £14.4m (vs £18.2m prior year; vs N+1 Singer’s £20.7m), and the reported cash position at period end was £12.6m (vs. £21.3m 30 Sept 2019). The Group has previously indicated cash runway until early 2021.
ReNeuron has released further follow-up data from the ongoing human retinal progenitor cell (hRPC) trial, which shows a robust sustained averaged response. This data set completes the six-month data on eight patients and extends, for one individual, to 18 months, who showed a good net gain. The next dose level, two million cells in nine patients, remains delayed due to COVID-19. A filing to start a pivotal study is expected in the second half of CY21. Our indicative value remains at £107m.
Hemogenyx (HEMO.L): Agreement with GlobalCo (from Friday) | ReNeuron Group (RENE.L): Positive data from ongoing Phase 2 retinal cell therapy trial
Companies: HemoGenyx Pharmaceuticals Plc (HEMO:LON)ReNeuron Group plc (RENE:LON)
We are encouraged by today’s Phase IIa data from the hRPC programme in Retinitis Pigmentosa (RP) and continued clinical meaningful improvement in the treated eye vs. the untreated eye of 8.9 and 8.8 letters at 6 and 12 months, respectively. All patients have now reached 6 months of treatment, although one patient now has reached 18 months and continues to show a highly encouraging 16.0 letter improvement vs. the untreated eye. We believe analysing the 8 patients who had a successful surgical operation, and excluding the two patients who had surgical complications, is the most appropriate dataset. The recovery in eyesight of one of the two patients who had surgical complications is good news, but we exclude from our analysis. Whilst it is possible, we think this recovery is unlikely to be the result of the hRPC therapy. As previously announced, nine additional patients are expected to be recruited into the Phase IIa trial and sufficient data is expected to be available from the trial to seek approval in H2 2021 to commence a single pivotal clinical study in RP. We view today’s results to be supportive of ReNeuron’s investment thesis and the new primary focus on RP. We make no changes to our forecasts or valuation analysis, and look forward to further updates from the hRPC programme.
ANGLE plc (AGL.L): Preliminary results | ReNeuron Group (RENE.L): Exosome research agreement with unnamed major US biotechnology company
Companies: ANGLE plc (AGL:LON)ReNeuron Group plc (RENE:LON)
ReNeuron has announced its 3rd exosome collaboration agreement and has made another step to justifying the strategic shift to exosomes as announced earlier this month. As a reminder ReNeuron’s exosomes are derived from human neural stem cells, and are clinical-grade, scalable and have a natural ability to cross the blood-brain barrier. Exosomes can be used to deliver therapeutics for diseases of the brain. The agreement today is with an undisclosed major US pharmaceutical company, but like the previous exosome agreements (announced in April 2020 and Jan 2019), it is a research evaluation agreement and carries little immediate financial bearing. Nevertheless, proof-ofconcept in specific disease areas expected on the back of agreements could enable lucrative out-licensing agreements. We note there has been a spate of recent and highly rewarding licensing agreements with exosome developer peers - Codiak (with Sarepta and Jazz) and Evox (with Takeda and Eli Lilly). In particular, we note that the Codiak-Sarepta deal was valued at $72.5m in upfront and near-term license payments. We make no changes to our forecasts or valuation analysis at this juncture, but will continue to follow the exosome platform closely. We reiterate our positive stance on ReNeuron.
ReNeuron has changed its focus to concentrate on cell therapy for retinal disorders. The Phase I/II has FDA clearance to use a higher dose and a new UK trial site in Oxford has been added. A pivotal study may start in H221. The CTX cell line for stroke will now be out-licensed. Internally, it will be used to produce exosomes, an emerging new area. Preclinical exosome technology might be used for therapeutic delivery to the brain and in vaccination or treatment of SARS-CoV-2 infections. Our indicative value is adjusted to £107m, formerly £197m, pending full FY20 results due in July.
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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
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
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
One of the original assumptions in our forecast for Destiny’s first product, XF-73 for the prevention of post-surgical staphylococcal infections, was that it would share the US market with GlaxoSmithKline’s Bactroban Nasal - despite Bactroban Nasal not being approved for this indication. We also referenced Bactroban Nasal’s US price in estimating the price for XF73 in all markets. Bactroban Nasal has now been discontinued in the US, so we adjust some of our modelling for its removal. This has resulted in our valuation increasing.
Companies: Destiny Pharma Plc
IXICO has provided a trading update for the fiscal year to 30 September 2020, expecting revenues of £9.5m, up 26% and ahead of our current £9.1m estimate. EBITDA is expected to be at least in line with our £1.1m forecast. This represents the fourth consecutive year of +25% revenue growth and a period over which EBITDA has progressed from -£2.1m (FY16A) to +£1.1m. FY21E revenues and beyond are underpinned by an order book which has increased by c£5.8m over the year supported by new contracts booked of over £15m, approximately twice the amount booked in FY19A. We believe IXICO is a strong position to deliver ongoing growth and we maintain our Buy recommendation.
Companies: IXICO Plc
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
A positive AGM update from CVS this morning, illustrating a continuation of solid trading momentum since the Sept finals. LFL sales in the first four months were ahead by 5.1% vs a stiff 8% comp. This implies an acceleration to 6.3% over Sep-Oct - an excellent showing, reflecting resilience and ongoing self-help to optimise revenue generation. Significantly, this flows through to a healthy EBITDA margin back above 15%. Trading during the current lockdown has not been much impacted and this bodes well for any future restrictions. The balance sheet has further deleveraged. With guidance remaining suspended we hold off reinstating forecasts, but on our illustrative analysis the shares are trading on an FY21/FY22 EV/EBITDA rating of 14x/13x and a P/E of 22x/21x. Given the structural tailwind, underlying momentum and sector M&A at >15x EV/EBITDA, we see scope for rating expansion.
Companies: CVS Group plc
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.
After Pfizer and Moderna, AstraZeneca-Oxford reported (preliminary) late-stage results for their COVID-19 vaccine candidate. Based on logistics and pricing, Astra’s vaccine has clear advantages.
However, with results for other (major) countries still awaited and considering past safety concerns, it is pre-mature to decide if Astra has won this race. Also, considering the firm’s ‘no-profit’ commitment as long as the pandemic is on, any major earnings uptick seems unlikely.
Companies: AstraZeneca PLC
A number of REITs have the ability to thrive in current market conditions and thereafter. Not only do they hold assets that will remain in strong demand, but they have focus and transparency. The leases and underlying rents are structured in a manner to provide long visibility, growth and security. Hardman & Co defined an investment universe of REITs that we considered provided security and “safer harbours”. We introduced this universe with our report published in March 2019: “Secure income” REITs – Safe Harbour Available. Here, we take forward the investment case and story. We point to six REITs, in particular, where we believe the risk/reward is the most attractive.
Companies: AGY ARBB ARIX BUR CMH CLIG DNL HAYD NSF PCA PIN PXC PHP RE/ RECI SCE SHED VTA
ANGLE plc (AGL.L): Acceptance of FDA submission | Feedback plc (FDBK.L*): Partnership agreement | Open Orphan (ORPH.L): Human Challenge Study Model contract with UK Government
Companies: AGL FDBK ORPH
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
Creo Medical (CREO.L): Acquisition of Boucart Medical | IXICO plc (IXI.L): New contracts
Companies: Creo Medical Group Plc (CREO:LON)IXICO Plc (IXI:LON)
Successful trials in Tesco have led to the W7 brand being distributed in a significant number of additional stores, including Tesco Extras. Performance in Wilko of its Technic and Body Collection brands has been ahead of expectations, leading to additional gift ranges being stocked there too. These distribution gains bode well for incremental sales/profit next year, and underline the appeal of the group’s value-for-money on-trend brands. Valuation is undemanding, particularly with the added attraction of a 6.4% dividend yield.
Companies: Warpaint London PLC