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Despite the restrictions caused by the ongoing COVID-19 pandemic, Onxeo has managed to initiate a new Phase Ib/II REVOCAN study in relapsed ovarian cancer, which evaluates AsiDNA’s potentially unique ability to reverse tumour resistance to the PARP inhibitor, niraparib. First data are expected in early 2021. Onxeo also reported updated results from the second cohort in the Phase Ib study with AsiDNA plus chemotherapy in various solid tumours. Onxeo’s second lead product from the platON platform
Companies: Onxeo SA
Currently, Onxeo is running a triple combination Phase Ib study (n=6; AsiDNA plus carboplatin plus paclitaxel). Top line results should be available by end-2020, subject to the COVID-19 pandemic impact. A major expansion of the R&D programme is the new Phase Ib/II REVOCAN trial. This new study will evaluate AsiDNA’s potentially unique ability to reverse tumour resistance to the PARP inhibitor, niraparib. First data are expected by the end of 2020 or early-2021. The outcomes of these studies will
On 18 September 2019, Onxeo released initial results from the first cohort of patients (n=3) in its ongoing Phase Ib DRIIV study with AsiDNA. The three patients had a progressive metastatic cancer (non-small cell lung cancer, triple negative breast cancer, gastric cancer) and were treated with AsiDNA plus carboplatin. No dose-limiting toxicity was observed. Two of the three patients have shown stable disease (RECIST) since the start of the treatment (more than four and five months). While it is
Onxeo is focused on the development of the next generation of DNA damage repair inhibitors from its novel oligonucleotide platON platform. The lead asset, AsiDNA, belongs to the same class of drugs as PARP inhibitors, but has a different mechanism of action. AsiDNA is in a Phase Ib trial in combination with chemotherapy in solid tumours; preliminary results are expected by end-2019, which is within the existing cash reach to Q320. To reflect the progress Onxeo has made with AsiDNA we have includ
On 24 April, Onxeo announced that the first patient had been treated with AsiDNA, a first-in-class DNA break repair inhibitor, via systemic administration in the Phase I trial. AsiDNA has already generated supportive data from a Phase I trial in melanoma using intratumoural injection. Alongside the Phase I trial Onxeo is conducting a broad preclinical programme that explores AsiDNA in various settings and combinations with other drugs. Two abstracts with preclinical data were presented at the Am
Onxeo has experienced a volatile 2017 mainly due to Livatag’s Phase III ReLive not meeting its primary endpoint. The out-licensing of Validive, fresh data from several preclinical studies with core assets – AsiDNA and belinostat combinations – were more positive recent developments. Although the share price halved after the disappointing ReLive data, the asset portfolio has been radically reshaped to focus on DNA break repair inhibition and epigenetics and Onxeo has cash reach until 2020. Our up
As announced on Monday evening, the Phase III stage Livatag did not meet the primary endpoint of improving survival in hepatocellular carcinoma (HCC) patients after treatment failure with sorafenib over the comparison arm, where patients received the standard of care (SoC). This morning, Onxeo announced that it had out-licensed its Phase III ready orphan oncology asset Validive to Monopar Therapeutics for a total deal value of $108m and up to double-digit royalties.
Yesterday Onxeo announced its first preclinical proof-of-concept data with AsiDNA demonstrating the potential to be administrated intravenously. AsiDNA, a first-in-class DNA repair inhibitor, has already been tested in a Phase I trial with melanoma patients and showed promising results in terms of safety and initial signs of efficacy administered via local injection. After Onxeo acquired the drug in February 2016, the company repositioned the development and now seeking to establish a pre-clinic
The major near-term catalyst for Onxeo will likely be the Livatag Phase III data in second-line liver cancer, which is expected around mid-2017. During 2017 we also expect new asset AsiDNA to advance into clinical testing, and progress with Beleodaq (belinostat), which could start the regulatory required Phase III trial. Onxeo is increasingly focused on exploring further opportunities for these assets, and has a number of preclinical collaborations ongoing. While data from these early-stage stud
With its H116 results, Onxeo reported that R&D is progressing according to plan. Preliminary data from the Phase III ReLive trial with Livatag are due around mid-2017, which is the main catalyst in the next 12 months. Update on the newly acquired DNA repair asset, AsiDNA, revealed that the project could enter the clinic already next year. Although sales of Onxeo’s third product Beleodaq somewhat lagged our expectations, H116 operating costs were managed well, suggesting that the key catalysts ar
With its acquisition of DNA Therapeutics, Onxeo has added a clinical stage signal-interfering DNA (siDNA) technology, which has already been tested in a Phase I trial for melanoma and demonstrated an attractive safety profile and preliminary anti-tumour activity, when administered locally. The new product called AsiDNA is a first-in-class and differentiated asset in the up-and-coming DNA repair interference field. Our increased valuation of Onxeo is €343m.
With Phase I data confirming the existing safety profile from the BelCHOP (Beleodaq with CHOP) study in the treatment of frontline PTCL, the path is now clear for initiation of the planned Phase III trial during H116 with partner Spectrum. Beleodaq is one of a trio of orphan oncology assets under development at Onxeo, also including Livatag (liver cancer), which has now completed seven safety reviews, and Validive (oral mucositis arising from chemoradiotherapy). New preclinical collaborations fo
The next major value inflection point for Onxeo will likely be availability of Phase III Livatag data for second-line liver cancer expected H117. This product could potentially be the first launched by Onxeo in Europe as part of the orphan oncology strategy. Prior to Livatag data, progression with Beleodaq and Validive is expected, with the start of further Phase III trials anticipated in H116. Our valuation, which is largely unchanged at €328m, suggests the current share price is ascribing limi
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EKF has reported a strong H1, with revenues of £37.5m and double-digit growth in underlying non-Covid related business. Management reports it is trading in line with expectations for the full year and we make no change to our profit forecasts at this stage. New growth initiatives are proceeding to plan and should lead to accelerated core growth from FY23 onwards. We continue to see substantial upside on successful execution with the shares trading on an FY23 P/E of 13.1x and an EV/EBITDA of just
Companies: EKF Diagnostics Holdings plc
Singer Capital Markets
Kromek reported full-year results to 30 April that were in line with the trading update of 16 May. Record visibility over our FY 2023 revenue forecast of £18m (c.53% of which is already contracted and 37% “Awarded not Contracted”, with the balance from its normal monthly run rate) is a great start for FY 2023 on which the company can build further. We are leaving forecasts unchanged for the moment, despite additional contract wins, and expect to introduce FY 2024 forecasts at the time of its int
Companies: Kromek Group Plc
Kromek announced a £1.7m fundraise by way of the issue of convertible loan notes (8% coupon, 18-month conversion period at 15p per share), which will allow the company to minimise any potential supply-chain disruption to the delivery of contracts during the year. We make only minor changes to forecasts to reflect the additional interest (c.£0.1m) accrued, with adjusted pre-tax loss increasing to £5.0m. We leave our target valuation of £118m (27p) unchanged, with near-term catalysts (e.g. a secon
Ahead of its upcoming results, ECO has issued an update flagging an issue around a sales tax liability and the treatment of certain items of capitalised development, offset by a foreign exchange gain will result in it reporting FY22 Adj EBITDA of ~£6.5m vs SCMe £7.1m. It has also indicated trading in China has been difficult in Q1 FY23, particularly with the large producers, but margins have improved on mix. Trading in the Rest of the World has been strong YTD. Given the proximity to the results
Companies: ECO Animal Health Group plc
Companies: Omega Diagnostics Group PLC
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Unigel Group, intends to join the Aquis Growth Market. Unigel Group is a pioneer in the field of thixotropic gels for the fibre optic cable industry. The Company is also a supplier of laminated steel tapes to the fibre optic cable industry in the US. Thixotropic gels and laminated steel tapes are essential components to the rapidly growing global fibre optic cable market. The Group export
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Smith & Nephew reported mostly in-line Q2 22 numbers, missing the top-line estimates (-0.6%) but beating on the trading profit (+0.5%), albeit marginally.
The Q2 performance was overshadowed by a 100bp margin downgrade for FY22 (-50bps Y-o-Y vs +50bps previously), which sent the stock ~9% lower in the session following the update. The reiteration of the top-line growth outlook of 4-5% was no help either.
We will cut our estimates, largely to reflect the soft margin guidance.
Companies: Smith & Nephew PLC
In Q2, Astra sustained its solid top-line momentum. Like in the past few quarters, this outperformance was again driven by higher COVID-19 business sales and solid growth in Diabetes drug Farxiga. Moreover, the recovering Oncology and much-needed green shoots in Rare Diseases were the icing on the cake. Although, profitability again came under the scanner but should improve in the coming quarters/years as the company completes its ‘growth phase’. Overall, a decent set of results and our positive
Companies: AstraZeneca PLC
Companies: SourceBio International Plc
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Inteliqo Limited, intends to join the Aquis Growth Market. Inteliqo Limited provides sales, marketing and distribution services to technology product owners under long-term distribution agreements. The Company has agreed its first such agreement in respect of the Ipedia iQ product range. The iQ product is a smart translation earphone (earbuds) system which offers integrated real time speech
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Belluscura has announced that it has entered into a Group Purchasing Organisation Product Supply Agreement with VGM Group which further expands its distribution network across the US.
Companies: Belluscura PLC
Companies: Argo Blockchain Plc (ARB:LON)Kromek Group Plc (KMK:LON)
For the year to 30 April 2022 Kromek reported results in line with the Trading Update of 16 May: revenue of £12.1m, +16.5%YoY, and an EBITDA (adj.) loss of £1.2m. We estimate revenue in the Advanced Imaging division grew 28% YoY to £4.6m, whilst the CBRN segment grew 1.5x to £5.4m.
Kromek reports that it expects growth to accelerate in both its core segments – security-related CBRN and advanced imaging – with the prospect of “a substantial year-on-year increase in revenue”. The CBRN segment in
Feature article: Utility regulation – Changes afoot - Patching up a tainted model
While the gas supply crisis – and its price implications – have dominated the UK price regulated sectors in recent months, other issues have arisen that have seriously tainted the price regulation system itself. Indeed, it is fair to ask whether it is ‘’fit for purpose’’.
Back in 1984, price regulation, via an unsophisticated RPI-x formula, was introduced to prevent the privatised British Telecom (BT) from abusin
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Hardman & Co