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 ...
MaaT presented new preclinical data for MaaT034 (donor-independent co-cultured microbiome therapy) at the American Association for Cancer Research (AACR) conference, being held 25-30 April in Chicago. The results show the potential for microbiome therapies to improve responses in solid tumours when combined with immune checkpoint inhibitors. Results from a phase 2 investigator-initiated placebo-controlled trial of MaaT013 (microbiome therapy, enema formulation) in combination with checkpoint inh...
MaaT announced the positive outcome of a key DSMB safety interim analysis for the phase 2b trial (PHOEBUS), which compares the efficacy and safety of MaaT033 (microbiome therapy, oral capsule) to placebo in patients undergoing an allogeneic hematopoietic stem cell transplantation (allo-HSCT). We are encouraged by the DSMB outcome, particularly in the context that allo-HSCT is a high risk patient population, and see this as supportive of MaaT033´s good safety profile. We note that MaaT033 is next...
MaaT will present new non-clinical data on MaaT034 (donor independent microbiome therapy) at the American Association for Cancer Research (AACR) conference, taking place on 25-30 April. The results demonstrate MaaT034's potential as a combination therapy to improve responses to checkpoint inhibitors in solid tumours. Being co-cultured means MaaT034 is donor-independent, which offers the scale required for the larger solid tumour market. Initial data from the phase 2 placebo-controlled trial of l...
MaaT reported FY24 results with the key item being the private placement of € 13m supported by existing shareholders. This extends the company's runway into October 2025 (previously into 2Q25) and provides sufficient funding to reach a number of milestones including MAA submission for MaaT013 to the EMA (June 2025), and enables the company to make progress with its regulatory interactions with the FDA to clarify the route to market in the US. On the pipeline front, we continue to look forward to...
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