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MediGene AG
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 to progress well with bluebird bio announcing that the MAGE-A4 product will enter the clinic in 2020. In addition, partner Cyotvant has announced that the first TCR (CVT-TCR-01) product candidate will focus on patients with either NY-ESO-1 expressing synovial sarcoma, MM or solid tumours, while a DC vaccine (CVT-DC-01) will be tested in patients with WT-1/PRAME expressing AML. We value Medigene at €465m (€18.94/share).
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 €23–28m. We value Medigene at €458m (€18.65/share).
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 leukaemia (AML) and myelodysplastic syndromes (MDS) is ongoing and the first patient has been treated; we now forecast initial data in H120. We have added the Roivant/Cytovant deal to our valuation and have removed Veregen following the sale of remaining rights and inventory to Aresus Pharma. We now value Medigene at €460m (previously €470m).
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 the sustainability of the responses. We have increased our probability of success for the DC vaccine trial to 30% from 25% previously, in addition to rolling forward our model and updating for FX. We now value Medigene at €470m (€19.16/share) vs €457m (€18.59/share) previously.
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 2019. Financials for 9M18 were above guidance, driven by a reduction in expected R&D costs. We now forecast a net loss of €16.9m in FY18 vs €18.4m previously. Additionally, Medigene announced an exclusive licence agreement with Leiden University to develop a TCR against HA-1, an antigen expressed in a range of cancers. We value Medigene at €457m.
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 read out in 2019. We have updated our forecasts and now value Medigene at €453m (€18.47/share).
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 TCR trial and the now fully enrolled Phase I/II DC vaccine trial will read out in 2019. We have updated our forecasts and now value Medigene at €416m (€18.65/share) vs €396m (€17.8/share) previously.
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-license to 2019. We value Medigene at €396m vs €316m previously.
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 compassionate use data on DC vaccines in AML. We value Medigene at €316m (€14.3/share).
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 (January 2014). We maintain our valuation of €315m but note the company is well-funded to deliver important milestones from progressing its clinical programme.
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 valuation to €315m (vs €293m), as we now include the cash from the fund-raising and have rolled the model forward.
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 impact, but see this as a significant and positive step.
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% (vs 5%), rolling the model forward and using FY16 cash.
Medigene has announced an alliance with bluebird bio, a prominent T-cell immunology company. It is Medigene’s first commercial partnering agreement based on its proprietary T-cell receptor (TCR) technology platform. The collaboration will seek to identify four TCR therapeutic candidates against four targets. This is a positive development as it validates Medigene’s TCR technology and makes use of technological synergies to develop new immuno-oncology products, which could prove beneficial. Importantly, it does this while retaining all rights for its proprietary TCR development programme and TCR library. We have increased our valuation to €233m (vs €219m), as we have rolled the model forward to an estimated Q3 position and included the upfront payment.
Medigene has announced that it has expanded its TCR platform technology with the grant of a US patent focused on a method for identifying T-cell antigens. This demonstrates Medigene’s continued advancement of its TCR technology, including providing a new source for potential TCR candidates and establishing a more efficient method for identifying tumour-specific antigens. We maintain our rNPV-based valuation at €214m, or €10.8 per share, with upside expected as it executes its clinical strategy.
Medigene has announced it has entered into a co-operation agreement to conduct a Phase I investigator-initiated TCR therapy trial (IIT), with grant funding, in patients with relapsed/refractory multiple myeloma. This is an important step forward in the process of bringing its TCR therapy to patients, a potentially transformational approach to treating certain cancers. The final aspect is the regulatory approval for the trial, to which Medigene is contributing. We expect the Phase I trial to initiate at end 2016/early 2017. We maintain our rNPV-based valuation at €214m, or €10.8 per share, with upside expected when the Phase I trial is initiated.
Medigene’s Q1 results continue to underpin its transformation to a cancer immunotherapy-focused company. Progress across its clinical pipeline continues to create further focus on clinical development and future commercialisation. Alongside management changes, this indicates that the company is executing its strategy. It is well funded, with a net cash position of €46.3m (Q116).
Medigene is well funded, with a net cash position of €46.8m (FY15). There is a clear strategy in place to advance both its DC vaccine programmes and TCR programme with the funds. We expect newsflow in the near term from its most advanced technology (DC vaccines) in Phase I/II studies for AML and prostate cancer, and the start of the first clinical study with its promising TCR technology. Our rNPV-based valuation remains at €216m.
Recent non-core, business-related newsflow has proved highly beneficial to Medigene. The full and final transference of EndoTAG-1 rights to SynCore and the sale of its Catherex subsidiary to Amgen for $10.5m (40% to Medigene) tidies up its legacy pipeline and IP assets, while providing a decent revenue stream. Medigene’s core focus remains on its immuneoncology franchise, and we look forward to significant progress in 2016. Our rNPV-based valuation increases to €216m or €10.98 per share.
The recent €46m capital increase allows completion of the Phase I/II DC vaccine trial in AML by 2018 and initiation of a broad immunotherapy clinical programme in TCR (adoptive T cell therapy). Stable revenues from Veregen underpin a strong cash position. Q215 results were broadly as expected. Adjusting for the capital increase and removing EndoTAG-1 from our DCF model, we value Medigene at €208m or €10.60 per share. This excludes any upside potential from SynCore or the Immunocore equity stake.
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