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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
Companies: IMM IBAB 0O8G BCART 0QLR RHO5 MRCK 0QXH VSC 0QGJ SANO 0OCQ IPH GSK AZN 0Y6X QGEN 0HL9 0GRZ EJXB 0Q15 ABBV 0HAV 0RIH 0R0T BMYS EXK 0J8Z 0R29 0R34 0K3W NSTGQ 0KCC 0Q1N SGEN 0R0H 12V VNRX XE9
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.
Companies: KMK BGEO CORA
Cavendish
Companies: BOIL ING TCF
TheraCryf (formerly Evgen) has reported a transformational 12-months to March 2024 and the post-period end acquisition of Chronos Therapeutics and equity raise. The company generated revenues of £0.4m in the year, in-line with expectations while controlling its costs base to deliver an operating loss ahead of our forecast. The company closed the year with cash of £2.0m, ahead of the April 24 equity raise of c£0.9m, gross. Operational progress through the year included securing grant funding for
Companies: TheraCryf PLC
TheraCryf reported a net loss for FY24 of £3.1m together with cash and net cash of £2.0m, in line with our forecasts. Post year end, the company raised £0.8m (net) in conjunction with its acquisition of Chronos Therapeutics (Chronos), which trebled its drug development pipeline. The company has a financial runway through towards the end of FY26. Despite its advantages, TheraCryf trades on a fraction of the rating of peers with similar characteristics and has multiple prospective newsflow events
Capital Access Group
FY23 results were in line with expectations and demonstrated a year of significant commercial progress. Whilst Verici is still in the early stages of commercialisation, FY23 revenues of $1.0m from the ThermoFisher agreements signal an important juncture. Following the post-period gross raise of £6.5m, we expect accelerated commercial progress in FY24 and beyond, driven by a scale up in Tutivia, milestones/royalties from Clarava and potentially further licensing and collaborations from new and ex
Companies: Verici Dx Plc
Singer Capital Markets
As previously disclosed, Diaceutics delivered revenue of £23.7m for FY23, up 22% YoY (+19% in constant currency) and ended the year with £16.7m in cash and net cash. The reported net loss of £1.7m was in line with our forecast. This was the first year of executing the accelerated growth strategy which was reflected in the growth in revenue, the transition to a higher proportion of recurring revenue driven by adoption of the enhanced DXRX platform while an expanded and reorganised marketing struc
Companies: Diaceutics Plc
28th May 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, or it is a rumour Dish of the day Admissions: Delistings: Accrol Group Holdings (ACRL.L) has left AIM. China Nonferrous Gold Limited (CNG.L) has left AIM. What’s baking in the oven? ** Potential**** Initial Public Offerings: ITF announced: 7th May: Time To ACT plc, an engineering business focused o
Companies: QED ZOO ING INSP KRS STX EQT CEG LND
Hybridan
Shield is a commercial-stage pharma company delivering specialty products that address patients’ unmet medical needs, with an initial focus on iron deficiency (ID). Since its US launch in July 2021, Shield and its partner, Viatris, have increased physician awareness of the differentiating characteristics of Accrufer® as an oral ID drug, in order to ramp up prescriptions (Rxs) and generate sales traction. Positive Rx momentum in 2022 and 2023, is expected to accelerate in 2024 and 2025 with the r
Companies: Shield Therapeutics Plc
Hardman & Co
29th May 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, or it is a rumour Dish of the day Admissions: Time to Act (AQSE: TTA): an engineering business focused on technology for energy transition announces the admission of its Ordinary Shares to trading on the Aquis Stock Exchange Growth Market. The Company reported a revenue of £2.6m and a net income of
Companies: BEM SRES AAU KMK DCTA SYS REAT THX JADE
Companies: Oxford BioDynamics PLC
Shore Capital
New management has revitalised Avon. First half earnings were positive across-the-board and slightly ahead of our expectations.
Companies: Avon Protection PLC
Zeus Capital
Creo Medical’s FY23 results recapped strategic, regulatory and operational wins for its core electrosurgical device suite, including Speedboat’s approval for upper gastrointestinal (GI) procedures in Europe and launch of Speedboat UltraSlim. With MicroBlate and SpydrBlade nearing commercial launch and increased traction with partners Intuitive Surgical and CMR Surgical, we anticipate the product uptake curve to steepen in the medium term. FY23 was a solid year with 13.4% y-o-y revenue growth and
Companies: Creo Medical Group Plc
TheraCryf is a clinical stage drug development company focused on commercialising its proprietary formulation of sulforaphane, SFX-01, and two novel drug candidates acquired in the recent Chronos transaction. The primary targets for SFX-01 are cancer and neurodevelopmental disorders while TheraCryf's new orexin and DAT programmes, extend the company's reach into neuropsychiatric drugs, currently a very active area for acquisitions and partnering. Potential target markets total in the billions of
Evgen Pharma has acquired Chronos Therapeutics Ltd for a total upfront consideration of c£0.9m, payable in Evgen shares. Accompanying this, Evgen has conditionally raised gross proceeds of £0.85m through an equity placing with the potential to raise a further £1.0m through a retail open offer and additionally up to £2.0m. The proceeds will fund several initiatives including maintenance of the acquired Chronos Therapeutics patent portfolio and to continue support manufacturing for lead clinical a
Companies: IGP RUA BOOM
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