MaaT announced that the independent data safety monitoring board (DSMB) has completed the second pre-planned safety interim analysis of the ongoing randomised controlled phase 2b (PHOEBUS) trial of MaaT033 (microbiome therapy, oral capsule) in patients undergoing an allogeneic hematopoietic stem cell transplantation (allo-HSCT), and recommended that the study continue as planned. There were no safety concerns and no excessive mortality related to MaaT033 as of today. The upcoming routine DSMB re...
KBC Securities will host its annual life sciences conference on 25 September in Brussels. The event will include 14 exciting companies, both public and private, from the BeNeLux ecosystem and beyond. In this conference note, we provide an overview of the attending companies, as well as an outlook on KBC Securities' life sciences broader coverage.
MaaT reported 1H25 results with € 2.4m in revenues from the early access program (1H24: € 1.7m) for MaaT013 in aGvHD, which points to increased demand for the product ahead of a potential EU approval in 2H26. Pipeline timelines were reiterated and we look forward to the final data from the phase 3 trial for MaaT013 in aGvHD for confirmation of the initial survival data reported in January 2025 (54% at 1-year). Beyond aGvHD, data from the phase 2 trial of MaaT013 in combination with ICI in metast...
MaaT announced that it has secured a € 37.5m , 4-tranche financing from the European Investment Bank (EIB), which bears interest at 7%. In addition, MaaT will issue warrants to the EIB with each tranche. MaaT's previously communicated cash runway was into January 2026, which should now extend beyond that point following this additional funding, though we do note that disbursement of Tranches B to D is subject to operational and financing conditions, which we'd be keen to learn more about. All in...
MaaT signed a licensing, distribution, and commercial supply agreement with Clinigen in Europe for Xervyteg (MaaT013, microbiome therapy, enema formulation) in aGvHD for a € 10.5m upfront, € 18m in milestones, and mid-thirties flat royalty on sales. We believe this deal serves as validation of MaaT013's potential, and see the partnership as a de-risking event for MaaT013's commercialisation in Europe, given Clinigen's experience commercialising in haemato-oncology, with 3 products currently on t...
MaaT provides a business update, which reiterated the company's progress with respect to its pipeline, and following the previously announced EU regulatory submission for MaaT013 in aGvHD, the company continues to search for a commercialisation partner in Europe ahead of a potential approval in 2H26. Timeline for MaaT013 US trial launch shifts to 2026 (from 4Q25) to focus resources on the European opportunity. Looking ahead, data updates for MaaT013 in aGvHD (final results incl. 12-month OS), as...
MaaT reported updated early access program (EAP) results for MaaT013 (microbiome therapy, enema formulation) in aGvHD at EHA, being held 12-15 June. The data, which was previously shared in the abstract last month, shows that the response rates and overall survival observed in the steroid refractory and ruxulitinib resistant subset of patients (n=70) are in line with what was observed in the phase 3 ARES trial. In our view, this points to the consistency of outcomes with MaaT013 in this patient ...
MaaT announced the submission of the Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) for its lead drug candidate MaaT013 (microbiome therapy, enema formulation) in aGvHD under the brand name Xervyteg. Potential approval could be granted in 2H26, and MaaT is actively exploring strategic partnerships to commercialise MaaT013 in Europe. We believe the solid phase 3 results and good uptake in the early access program will be supportive of MaaT013's commercial launch ...
The abstracts for presentations at EHA (12-15 June) became available yesterday during the day (here). While we may have to wait until the actual conference for the latest datasets, here in this note are some key takeaways for our coverage including updates from Autolus (long-term findings and predictors of sustained remission for Aucatzyl in r/r adult ALL, as well as age stratified outcomes), Galapagos (more data and follow up from its decentralised CAR-T program) and MaaT (additional data from ...
MaaT reported 1Q25 results with revenues of € 1.1m (1Q24 € 0.8m), and a cash position of € 24.4m (YE24: € 20.2m), which provides a cash runway into October 2025. Pipeline timelines were reiterated and we look forward to phase 2 data for MaaT013 in combination with immune checkpoint inhibitors in metastatic melanoma in 2H25, and hope to learn more about the company's progress with respect to partnering discussions for MaaT013 in aGvHD in Europe as we approach MAA submission in June 2025. We reite...
MaaT reported additional results from the exploratory single arm phase 1b trial of MaaT033 in ALS, and we view the slower disease progression observed with MaaT033 as encouraging, though we also note the small patient numbers and single arm nature of the trial. ALS is a difficult condition, where many drugs have failed to show slowing of disease progression. As such, MaaT033's early results are promising, and the company is seeking partners focussed on ALS to progress this program. We reiterate ...
Unfortunately, this report is not available for the investor type or country you selected.
Report is subscription only.
Thank you, your report is ready.
Thank you, your report is ready.