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H117 results released, business on track

Update | Pharmaceuticals & healthcare | 15 Nov 2017

Hybrigenics has reported H117 financial results which have been restated to reflect the sale of the proteomics division. Hybrigenics continues to generate preclinical data from its inhibitors of ubiquitin-specific protease (USP) programme. Inecalcitol’s Phase II studies in acute myeloid leukaemia (AML) and chronic myeloid leukaemia (CML) will be expanded to other countries and combinations with other kinase inhibitors, respectively. Net cash at end July 2017 was EUR 11m which we estimate provides runway into 2019. Our updated valuation is EUR 129m or EUR 2.75/share.


Fresh funds to expand clinical studies and R&D

Update | Pharmaceuticals & healthcare | 29 Aug 2017

Hybrigenics has raised EUR 6.8m in gross proceeds through preferential subscription rights with new and existing investors. We believe the proceeds will provide funding into 2019 and enable Hybrigenics to expand the ongoing Phase II studies with inecalcitol in acute myeloid leukaemia (AML) and chronic myeloid leukaemia (CML). Additionally, the company will use the cash to continue the research in the field of inhibitors of ubiquitin-specific protease 7 (USP7) or 8 (USP8). Our valuation, which does not yet include the offering, stands at EUR 141m.

Jupiter Green Investment Trust

Quality growth through environmental solutions

Review | Investment trusts | 29 Aug 2017

Jupiter Green Investment Trust (JGC) invests in companies around the world that are providing solutions to environmental challenges. It aims for capital growth from a portfolio of c 60 companies, chosen through a disciplined, bottom-up investment process with a focus on quality and valuation. The trust is managed by a team at Jupiter Asset Management who also run the UK’s first environmentally focused collective investment fund, Jupiter Ecology. The managers report that their investment universe has expanded considerably as environmental issues have become more mainstream and technological advances have made companies in areas such as renewable energy more competitive. JGC’s small size and closed-end structure allow the managers more flexibility to invest in smaller, less liquid and potentially higher-growth companies than in their larger open-ended mandates, including up to 5% in unlisted stocks.


Pipeline on track, accounting standards shift

Update | Pharmaceuticals & healthcare | 18 May 2016

Hybrigenics reported €11.7m in cash at end 2015. This provides a runway to end 2017, funding a Phase II trial of inecalcitol in acute myeloid leukaemia (AML) in France and the US. Interim data from a Phase II study in chronic myeloid leukaemia (CML) are expected this year. Furthermore, the company has changed its accounting rules from French GAAP to IFRS; we have updated our model on this basis. This update, together with splitting inecalcitol revenues in chronic lymphocytic leukaemia (CLL) between the EU and US (reflecting different economics), increases our valuation to €137m from €120m.


Termination of coverage

Termination | Pharmaceuticals & healthcare | 10 Jan 2019

Edison Investment Research is terminating coverage on Hybrigenics (ALHYG). Please note you should no longer rely on any previous research or estimates for this company. All forecasts should now be considered redundant.


Leukaemia pipeline advances with new data

Update | Pharmaceuticals & healthcare | 24 May 2018

Hybrigenics has published data from a Phase II study in chronic myeloid leukaemia (CML). After one year of treatment, 40% of patients showed improvements beyond a major molecular response (MMR) and 20% achieved a deep molecular response (DMR), consistent with a functional cure. The ongoing Phase II trial in acute myeloid leukaemia (AML) will complete enrolment before end 2018, with data readout in 2019. Hybrigenics has completed its refocusing on R&D with the sale of the genomics division, Helixio. The internal R&D programme on ubiquitin-specific proteases (USP) inhibition continues. Hybrigenics also has an R&D partnership with Servier focused on oncology worth up to €12m. Cash at end 2017 was €7m. Our valuation is €129.5m or €2.77/share.


Inecalcitol advancing towards data

Outlook | Pharmaceuticals & healthcare | 31 Jan 2018

Hybrigenics’ main value driver is inecalcitol. A Phase II study in chronic myeloid leukaemia (CML) is on track to complete in H218. Interim analysis showed 33% of patients had a response after one year of treatment. A Phase II trial in acute myeloid leukaemia (AML) is ongoing with data expected in mid-2019. In another Phase II trial in chronic lymphocytic leukaemia (CLL), inecalcitol slowed progression in half of patients. In the field of inhibitors of ubiquitin-specific proteases (USP) the company has its own drug discovery programme and an R&D partnership with Servier focused on oncology worth up to EUR 12m. Our valuation is broadly unchanged at EUR 121m or EUR 2.6/share.


Inecalcitol shows promise in CML, R&D refocus

Outlook | Pharmaceuticals & healthcare | 12 May 2017

Hybrigenics' main focus is the development of inecalcitol as a niche treatment for leukaemia. In February it presented encouraging initial results for inecalcitol in combination with oral imatinib in chronic myeloid leukaemia (CML), with 43% of patients responding in a Phase II study that will complete in H218. A Phase II trial in acute myeloid leukaemia (AML) is ongoing with data expected in H119. Inecalcitol is Phase III-ready for chronic lymphocytic leukaemia (CLL) where it slowed progression in half of patients. The company has sold the proteomic services division and refocused on biopharma R&D. Our valuation is €141m; net cash at end 2016 was €8.5m.


Encouraging initial CML clinical data

Update | Pharmaceuticals & healthcare | 17 Feb 2017

Hybrigenics has presented the first ever clinical data from an interim analysis of a Phase II study of inecalcitol in combination with imatinib in patients with chronic myeloid leukaemia (CML). At interim, 43% of patients who had been on treatment for three months showed improvements to baseline MMR (major molecular response). Furthermore, 33% of patients who had completed one year in the study achieved a deep molecular response (DMR). Achieving and sustaining a DMR may allow patients to discontinue treatment (functional cure). Therefore, we believe these are encouraging preliminary data that provide first clinical insights into inecalcitol’s potential in CML. The study is expected to complete in H218. Our valuation stands at EUR 146.1m.


First patients enrolled in AML Phase II trial

Update | Pharmaceuticals & healthcare | 06 Dec 2016

Hybrigenics has started dosing the first patients in France and the US in a double-blind, placebo-controlled Phase II study in elderly or frail acute myeloid leukaemia (AML) patients. Data are expected in Q418 or H119. Additionally, an open-label Phase II study in patients with chronic myeloid leukaemia (CML) in combination with imatinib continues; an update will be provided by Q117. Hybrigenics has an R&D collaboration with Servier focused on oncology, from which it received a EUR 1.5m milestone payment in H216. Our updated valuation is EUR 146.1m or EUR 4.1/share.


Landing US orphan drug designation and an IND

Update | Pharmaceuticals & healthcare | 15 Feb 2016

Hybrigenics is progressing its vitamin D3 derivative inecalcitol through Phase II trials in orphan adult leukaemias. In addition to chronic lymphocytic leukaemia (CLL) and chronic myeloid leukaemia (CML), inecalcitol is prioritising acute myeloid leukaemia (AML) with the start of a Phase II study in France and the US in 2016. Interim Phase II data are expected in Q216 in CML. We lower our valuation from €143m to €120m as hormone-responsive prostate cancer (HRPC) has been put on hold while Hybrigenics focuses on castrate-resistant prostate cancer (CRPC).


Taking inecalcitol across the Atlantic

Outlook | Pharmaceuticals & healthcare | 28 Jul 2015

Hybrigenics is developing inecalcitol as a niche therapy in adult leukaemia. Disease progression slowed in 52% of patients treated in a Phase II chronic lymphocytic leukaemia (CLL) trial. We have increased our valuation from €108m to €143m as we assume that Hybrigenics will self-fund approval studies in leukaemia and achieve higher royalties vs our previous assumption. If the company advances inecalcitol into Phase II/III CLL studies there is upside scope to €173m.