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Edison Investment Research is terminating coverage on Augean (AUG), Deinove (ALDEI), Photocure (PHO), RADA Electronic Industries (RADA) and Ryvu Therapeutics (RVU). Please note you should no longer rely on any previous research or estimates for these companies. All forecasts should now be considered redundant.
Companies: Selvita SA (787:FRA)Selvita SA (SLV:WAR)
Edison
2020 has been a memorable year for Ryvu. Menarini, the partner sponsoring SEL24/MEN1703 development, completed the Phase I part of the Phase I/II trial in acute myeloid leukaemia (AML) and presented the first ever data with an in-house developed asset. In April 2020, Ryvu signed a discovery agreement in inflammatory diseases with Galapagos. Ryvu could receive up to €53.5m (€1.5m paid upfront). On the internal R&D front, the company has terminated two preclinical stage projects for strategic reas
In our March 2020 report, we highlighted that Ryvu, now a pure-play biotech with a diversified R&D pipeline, is funded into 2021, which positions it well to weather the COVID-19 pandemic. Ryvu’s shares underwent a period of volatility during the initial stages of the pandemic, but are now trading at an all-time high after the corporate split in October 2019. Although the full extent of the COVID-19 impact is not yet known, Ryvu described the measures it has undertaken in its FY19 annual report i
Companies: Ryvu Therapeutics SA (0RKT:LON)Selvita SA (SLV:WAR)
In March 2020, Ryvu announced its partner Menarini Group (via subsidiary Berlin-Chemie) has successfully completed the dose-escalation part (Phase I) of the ongoing Phase I/II study with SEL24/MEN1703, a dual PIM/FLT3 kinase inhibitor in a Phase I/II trial for acute myeloid leukaemia (AML). The recommended dose for the Phase II part of the study (cohort expansion) has been established. Ryvu is a pure biotech, so the ongoing turbulence in the global markets has a limited effect on the outlook of
Ryvu Therapeutics (formerly Selvita) is now trading as a standalone biotech after its drug discovery services business was spun out in October 2019. According to the recent Q319 report, R&D progress is on track and 2020 is shaping up to be rather eventful, including expected data readouts from the two clinical trials with lead assets SEL120 and SEL24/MEN1703. Although the trials are early in terms of clinical development (Phase Ib and Phase I/II), they both include secondary endpoints, which wil
The corporate split is now complete and Selvita is continuing as Ryvu Therapeutics, which will focus on innovative drug development. The contract research organisation (CRO) business, which was spun out, has retained the Selvita brand and is also trading on the Warsaw Stock Exchange. Pawel Przewiezlikowski, co-founder and CEO of the former Selvita, continues to lead Ryvu Therapeutics, while Boguslaw Sieczkowski, co-founder and COO is now the CEO of the newly listed Selvita (CRO). We performed a
The corporate split is progressing well. The Polish Financial Supervisory Authority has approved the Selvita CRO Prospectus as part of listing on the Warsaw Stock Exchange and the shareholders' meeting approved the split. The current entity will continue as Ryvu Therapeutics, a newly introduced brand, and will fully focus on innovative drug discovery and development. The process should complete in October 2019. We believe both businesses have sufficient momentum to continue as standalone compani
Selvita’s announcement of an intention to split into two separate companies was the hallmark event in the Q418 results presentation. By end of 2019, the drug discovery services and oncology R&D will be split into separate listed entities (subject to financial authorities and shareholders' approvals. We believe both businesses have sufficient momentum to sustain such a split. The profitable Services segment again delivered substantial sales growth of 34% in 2018. The R&D pipeline is progressing a
The data readout from the SEL24 Phase I/II trial in relapsed/refractory AML and the second lead asset, SEL120, moving into clinical development next year are milestones in Selvita’s internal drug R&D. This should accelerate, as the company’s plans to focus on innovation were endorsed by shareholders during the fund-raise earlier in 2018. R&D progress across the earlier-stage pipeline has been reported in several publications in recent months. The Innovations Platform continues to receive support
Over the past several months Selvita has been executing on its new R&D-focused multi-year strategy funded by the share issue in March 2018 raising PLN134m and other sources. While sales continue to grow at an impressive rate in the Services business (up 53% in Q118), R&D progress across the pipeline has been reported in several publications in recent months. Our Selvita valuation is PLN1.30bn or PLN81.2/share versus PLN81.7/share previously.
Selvita’s FY17 revenues were PLN105.9m, up 59% y-o-y, with adjusted operating profit rising from PLN4.7m to PLN13.2m. This reflects strong organic growth, but profitability was also boosted by the SEL24 out-licensing deal to the Menarini Group, which contributed PLN13.0m to profit. The share issue completed in February 2018 raised PLN134m gross. This new money and funds from additional sources will support Selvita’s new R&D-focused strategy, which we have already included in our model. Our updat
On 16 December 2017, Selvita announced that the FDA had lifted the clinical hold on the Phase I/II clinical trial with the company’s lead drug candidate SEL24 (dual PIM/FLT3 kinase inhibitor) for refractory/relapsed acute myeloid leukaemia (r/r AML). The asset is now out-licensed to Menarini Group, therefore the two companies worked together with the FDA to resolve the issues. The trial can now be restarted with some modifications to the design. While only few details have been disclosed, Selvit
Selvita offers a two-pronged strategy with steady double digit growth from its drug discovery business coupled with potential upside from drug development within its broad R&D pipeline. Recently the company introduced a new strategy for 2017-2021 focused on continuing growth in the Services business and ramping up investment in the internal R&D pipeline. While this has been overshadowed somewhat by the clinical hold on the lead asset SEL24, our investment thesis for Selvita is based on supportiv
Research Tree provides access to ongoing research coverage, media content and regulatory news on Selvita SA. We currently have 13 research reports from 1 professional analysts.
Companies: BILN IGP RBN SBTX
Cavendish
Verici’s $8.2m gross raise means the company can now focus on scaling Tutivia and invest further into the development of existing and new products. With a uniquely well balanced Tutivia test, a growing sales team and LCD coverage expected later this year, we forecast Tutivia revenues of $2.6m/$4.5m in FY24E/FY25E. The Thermo Fisher deal was a huge validation of Clarava and Verici’s technology and in addition to licensing/milestone payments, we forecast double digit royalties on net Clarava sales
Companies: Verici Dx Plc
Singer Capital Markets
26th March 2024 @HybridanLLP Status of this Note and Disclaimer This document has been issued to you by Hybridan LLP for information purposes only and should not be construed in any circumstances as an offer to sell or solicitation of any offer to buy any security or other financial instrument, nor shall it, or the fact of its distribution, form the basis of, or be relied upon in connection with, any contract relating to such action. This document has no regard for the specific investment object
Companies: BIRD MBH CHRT INSE KMK FNTL HDD JNEO CCS
Hybridan
Companies: Aptamer Group Plc
Turner Pope Investments
The Hardman & Co Healthcare Index (HHI) has been running since 2009. Its main function is to highlight the attractions of life sciences investments over the long term. For the second year running, apart from global economic influences affecting world markets, performance in 2023 was dented by the capital-intensive nature of the sector. The HHI fell 3.7%, to 483.8, underperforming the main London markets – FTSE 100 (+3.8%) and FTSE All-Share (3.8%) but outperforming the FTSE AIM All-Share Index (
Companies: TXG NDVA TSVT BCOW Z29 TXG NCYT GNS SUN AMS OMG APH EKF EAH IMM AGL DEMG AGY TSTL IPO GDR ETX TRX HVO CTEC AVO OXB DEST VLG IXI VAL INDV AGR AVCT BAI 123F IMCR BCOW
Hardman & Co
SkinBioTherapeutics has reported on the 6-months to December 2023, noting steady revenue growth from lead product AxisBiotix-Ps, progress on the development of SkinBiotix with partner Croda (Sederma) and post-period end, the acquisition of Dermatonics. The company has updated on several positive developments through the start of 2024, including AxisBiotix Acne positive interim results, initiation of research on the MediBiotix Pillar and progress with the oral and inflammation programmes. The com
Companies: SkinBioTherapeutics Plc
Companies: CLBS GHH NANO TRX SAVE TMT GELN
On 18th December 2023 Incanthera announced a deal with Marionnaud in Switzerland to distribute ‘Skin+CELL’, its advanced dermatological solution for the delivery of vitamin B3 for skin protection and cosmetic rejuvenation. This gives Incanthera access to a high-end cosmetics distribution presence in Europe, and in addition, ownership of Marionnaud by AS Watson, the largest cosmetics distributor in Asia, offers significant new market opportunities further afield.
Companies: Incanthera Plc
Stanford Capital Partners
FY EBITDA and EBIT came in materially above consensus FY EBITDA came in at EUR98.8m, down 4% yoy and 12% above consensus. The EBITDA margin was 12.6%. Restated for one-off costs, it was 13.1%, more than 2 percentage points above the guidance. It was fully explained by price increases, notably on X-ray, mix and control of fixed costs. FY EBITA came in at EUR38m, 46% above consensus. 2024 guidance looks conservative Guerbet is aiming for organic growth above 8% (8.8%e). With markets growing at
Companies: Guerbet (GBT:EPA)Guerbet SA (GBT:PAR)
BNP Paribas Exane - Sponsored Research
IRLAB Therapeutics has confirmed the FDA’s alignment with its proposed Phase III programme for mesdopetam in levodopa-induced dyskinesias (PD-LIDs), following receipt of the minutes from its end-of-Phase II (EoP2) meeting held last month. Notably, the FDA has agreed on the primary endpoint being the Unified Dyskinesia Rating Scale (UDysRS), on which mesdopetam demonstrated a statistically significant improvement (p=0.026) in the Phase IIb study (secondary endpoint of that study). IRLAB will now
Companies: Irlab Therapeutics Ab
Tissue Regenix has reported on strong performance through 2023, noting record revenues driven by product adoption and expanded distribution, positive adjusted EBITDA for the first time and an increased cash position versus H1/23. FY23 revenues grew 20% to $29.5m supported by 25% growth from BioRinse products and 17% growth from dCELL products. Significantly, Tissue Regenix reported its first adjusted EBITDA profit for the year, +$0.9m, supported by revenue growth and cost management. We expect t
Companies: Tissue Regenix Group plc
Creo Medical has published a trading update for the 12 months to December 2023, during which the company focused on commercialising its core technology. Revenue for the period increased 13% YoY to £30.8m, while the underlying operating loss improved to £16.4m. Operationally, during the period, the number of confirmed users of Creo’s Speedboat range more than doubled over the year, the first procedures with MicroBlate Flex to ablate lung tumours were performed and Creo expects to receive regulato
Companies: Creo Medical Group Plc
Companies: NTQ KMK JNEO DCTA
LungLife AI is a medical diagnostics company focused on the development of AI-supported blood-based tests for the early detection of lung cancer. It has identified a significant medical need for non-invasive, sensitive and specific tests in early-stage lung cancer. The company’s core technology, the LungLB test, seeks to detect circulating tumour cells (CTCs) to identify malignant lung nodules. It aims to apply machine learning/AI (ML/AI) to derive algorithms to increase test accuracy. Following
Companies: LungLife AI, Inc.
This month's feature article is entitled 'Gold and a Chinese Credit Event'. A Western phenomenon? If you own, or are considering owning, gold or gold equities, it’s likely that you’re concerned about protecting your wealth, or the performance of your fund, in the expectation of some kind of financial instability. Maybe your confidence in policymakers is ebbing, or you’ve researched debt bubbles in history and concluded that physical gold and silver have been the safest places to be invested whe
Companies: NBPE ICGT ARBB CSN RECI CLIG HAT AVO STX VTA APAX
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