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Enrolment of patients in Medigene’s MDG1011 Phase I/II trial continues, albeit at a slower rate than initially expected, with initial data from the first three dose cohorts expected in Q420. Following promising interim data earlier in the year, the company forecasts that top-line dendritic cell (DC) vaccine data will be presented in Q120. In expanding the clinical pipeline, Medigene has announced that MDG1021 (HA-1 targeting TCR) will start its clinical programme in H120. Partnerships continue t
Companies: MediGene AG
Edison
The cancer burden is growing globally. Each year >18 million people are diagnosed, nearly 10 million die and the estimated economic cost exceeds $1 trillion. From early diagnosis to late-stage disease, cancer care often involves inappropriate or unnecessary interventions that drive costs but provide limited clinical benefit. Coupled with an increased understanding of cancer biology and rapid technological advances, this has been driving momentum for precision medicine, leading to patient and soc
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goetzpartners securities Limited
Medigene continued its positive momentum in H119 announcing a new partnership (Roivant/Cytovant), expansion of its internal pipeline (MDG1021), sale of a legacy asset (Veregen) and progression of a partnered product (Bluebird MAGE-A4). Patient enrolment in Medigene’s MDG1011 trial in multiple myeloma (MM), acute myeloid leukaemia (AML) and myelodysplastic syndromes (MDS) is ongoing and we forecast initial data in H120. The company reiterated its FY19 financial guidance of an EBITDA loss of €23–2
Medigene continues to position itself as a leader in cellular therapies by the expansion of both its internal pipeline (MDG1021) and external partnerships (Roivant/Cytovant). The company has announced MDG1021 (HA-1 targeting TCR) will start its clinical programme in 2020. A new partnership with Roivant/Cytovant (total deal terms >$1bn) demonstrates the ongoing value third parties see in Medigene’s technology and expertise. Medigene’s MDG1011 trial in multiple myeloma (MM), acute myeloid leukaemi
Medigene has reported top-line interim data from its Phase I/II clinical trial testing its dendritic cell (DC) vaccine in acute myeloid leukaemia (AML) patients (n=20) who were in complete remission. After a 12-month treatment period, overall survival was 89% (n=18/20) and progression-free survival was 60% (n=12/20). These early data are comparable to those of patients treated with allogeneic stem cell transplants. However, relapses are common in AML and long-term data are needed to determine th
Medigene’s MDG1011 trial in MM, AML and MDS is ongoing and the first MDG1011 TCR cell product has been successfully produced. Additionally, procedures to speed up patient enrolment are being rolled out, including the simplification of enrolment criteria and the addition of new trial centres. We continue to forecast that clinical data from both the Phase I part of the MDG1011 Phase I/II clinical TCR trial and the now fully enrolled Phase I/II dendritic cell (DC) vaccine trial will be available in
In H118, Medigene announced several key developments including the start of its MDG1011 Phase I/II TCR clinical trial, a gross capital raise of €32.3m (which expands cash reach past 2019) and the expansion of its bluebird partnership to cover a total of six targets (worth potentially US$1.5bn in milestones plus royalties). The MDG1011 Phase I/II clinical trial is enrolling patients and we forecast that the Phase I part of the TCR trial and the now fully enrolled Phase I/II DC vaccine trial will
Medigene has announced an expansion of its bluebird partnership, giving significant external validation of its T-cell receptor (TCR) technology platform. The full partnership now covers six targets and is worth potentially US$1.5bn in development and commercial milestones, in addition to royalties on any future sales. Medigene’s own internal pipeline continues to advance with its MDG1011 Phase I/II TCR clinical trial now enrolling patients. Additionally, we forecast that the Phase I part of the
Medigene has started its TCR Phase I/II clinical trial, making it one of the few clinical TCR companies globally. Combined with the completed enrolment of the Phase I/II DC vaccine trial, Medigene is positioning itself at the forefront of the next wave of cell and gene therapies. We expect initial data packages from both trials in 2019. We have updated our MDG1011 assumptions, rolled forward our model, adjusted for the sale of the US rights to Veregen, and delayed our assumed DC vaccine out-lice
Medigene’s Q3 results are in line with our forecasts. The company has submitted its Phase I/II clinical trial application for its lead TCR cellular immunotherapy product candidate MDG1011 and anticipates initiation of the trial by year end. In addition to the upcoming trial initiation, Medigene has made numerous scientific and technological achievements in 2017, including presentations on its automated TCR identification platform and preclinical data on MDG1011. Partners have presented compassio
Medigene’s H1 results are in line with our expectations and represent the completion of its transformation into a prominent T-cell immunotherapy player. Highlights from H1 include submission of a clinical trial authorisation (CTA) to begin its first clinical T-cell trial and a fund-raising of €20.7m (gross). We maintain our valuation at €315m, but expect upside as it executes on its strategy over the next 12-18 months.
Medigene has announced that it has submitted a clinical trial authorisation application (CTA) to begin its first clinical trial with its proprietary T-cell receptor (TCR) modified T cells. If approved, the trial will evaluate it as an immunotherapy to treat a range of blood cancer indications and will be one of the first in Germany of TCR-modified cells. The trial is expected to start by the end of 2017. This submission triggers a final milestone payment of €2m for the Trianta acquisition (Janua
Medigene recently announced a placing of €20.7m gross (issuing 1.96m new shares at €10.55) to intensify its R&D through the expansion of its planned T-cell receptor (TCR) modified T-cells clinical programme. This leaves it well funded (pro forma cash €67.7m) to advance both its DC vaccine programmes and TCR programme. We expect 2017 to be a year of important progress for Medigene, in particular the start of its first company-initiated TCR clinical study. We have increased our rNPV-based valuatio
Medigene has announced a placing of €20.7m gross (issuing 2m new shares at €10.55) to intensify its R&D through the expansion of its planned T-cell receptor (TCR) modified T-cells clinical programme. This was achieved with an accelerated book build process and became effective today. The fund-raising was over-subscribed and included both existing institutional shareholders and new specialised healthcare investors. We place our financial forecasts and valuation under review to assess the full imp
Medigene is well funded (FY16 cash €52.6m) to advance both its DC vaccine programmes and TCR programme. We expect a number of important milestones in 2017; specifically, we expect newsflow from its most advanced technology (DC vaccines) in Phase I/II studies for AML (complete enrolment) and the start of its first company-initiated T-cell receptor (TCR) clinical study. We have increased our rNPV-based valuation to €293m (vs €233m), to reflect the increase in the TCR programme probability to 13% (
Research Tree provides access to ongoing research coverage, media content and regulatory news on MediGene AG. We currently have 0 research reports from 2 professional analysts.
Edison Investment Research is terminating coverage on ABC Arbitrage (ABCA), paragon (PGN), Foresight Solar Fund (FSFL), Kendrion (KENDR), Lithium Power International (LPI), Triple Point Energy Transition (TENT), 4iG (4IG), e-therapeutics (ETX), Pharnext (ALPHA) and Shield Therapeutics (STX). Please note you should no longer rely on any previous research or estimates for this company. All forecasts should now be considered redundant. Previously published reports can still be accessed via our web
Companies: Shield Therapeutics Plc
Companies: Warpaint London PLC
Shore Capital
Cambridge Nutritional Sciences (CNS) has provided a trading update for the 12 months to 31 March 2024, noting that a combination of strong sales growth and significant margin improvements, driven by operational efficiencies, have played key factors in the group’s expectation of being adjusted EBITDA positive in FY 2024. Revenues are expected to be £9.8m (30% YoY growth), ahead of our £9.0m forecast, with gross profits expected to exceed £6m, which is again ahead of our year-end forecast of £5.6m
Companies: Cambridge Nutritional Sciences PLC
Cavendish
An official NHS Supply Chain case study has quantified the savings made by an NHS Trust from adopting Creo Medical’s Speedboat device to perform Speedboat Submucosal Dissection (SSD) in comparison to surgical alternatives. In total, the net cash saving from 130 SSD procedures for the NHS Trust was calculated at £687k, including savings from reduced length of hospital stay and reduced theatre costs. Notably, these savings did not include the patient and financial benefits associated with reduced
Companies: Creo Medical Group Plc
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22nd April 2024 * A corporate client of Hybridan LLP ** Arranged by type of listing and date of announcement *** Alphabetically arranged **** Potential means Intention to Float (ITF) has been announced Dish of the day Admissions: Delistings: What’s baking in the oven? ** Potential**** Initial Public Offerings: Reverse Takeovers: 16 April 2024: Electric Guitar (ELEG.L) Concurrent with its Admission to trading on AIM, Electric Guitar is proposing to acquire the entire issued share capital of 3radi
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Hybridan
Cambridge Nutritional Sciences (CNS) has published its H1 2024 results to end September 2023. Group revenues grew 44% to £4.9m and gross profits increased by 63% to £3.1m, with the company benefitting from newfound operational efficiencies. With its now streamlined strategy focussing on the core Health & Nutrition business and the initial signs of an encouraging uptick in sales momentum, we believe the company is well positioned for growth that will help create future value for shareholders. We
Feature article: Steady as she goes, but could be better: A review of investment company liquidity since 2016 Liquidity is the lifeblood of equity markets. The measurement of liquid asset availability to a market or company is a way of gauging a market’s health. This article builds on our previous work, which analysed the liquidity data for non-financial trading companies, by applying the same analytical techniques to the investment companies (IC) space. We analyse liquidity for ICs as a whol
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Hardman & Co
Companies: e-Therapeutics plc
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Venture Life has reported FY23 results to December 2023, following the February trading update. Revenues grew 17% in the year to £51.4m (our est. £50.7m) and adjusted EBITDA was £11.6m (our est. £11.6m). Cash conversion was 85%, generating £9.8m of cash from operations. Cash generation and no M&A in 2023 allowed the company to de-lever, closing FY23 with net debt to adjusted EBITDA at 1.3x. Management have focused on growth with three therapy areas generating double-digit revenue growth and onli
Companies: Venture Life Group Plc
17th April 2024 * A corporate client of Hybridan LLP ** Arranged by type of listing and date of announcement *** Alphabetically arranged **** Potential means Intention to Float (ITF) has been announced Dish of the day Admissions: Delistings: What’s baking in the oven? ** Potential**** Initial Public Offerings: Reverse Takeovers: 16 April 2024: Electric Guitar (ELEG.L) Concurrent with its Admission to trading on AIM, Electric Guitar is proposing to acquire the entire issued share capital of 3radi
Companies: ARS TIDE SCE SNX ECK CNS TST SPEC SSTY
Total reported revenues and other income were $17.5m (our forecast $16m) in 2023 vs $5.5m in 2022. The composition of that revenue was different to our expectations such that Accrufer US revenues of $11.6m compared with $3.6m in 2022 but came in below our estimate of $13.6m. In the release, the company has noted that the methodology used by the third-party data provider for US Accrufer scrips has resulted in an overstatement for 2023. Revised figures for 2023 have been given showing 77,000 total
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