reports
- Jacob Mekhael
EHA abstracts Autolus, Galapagos, MaaT
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 ...
- Guy Sips
- Jacob Mekhael
- Lynn Hautekeete
- Michiel Declercq
- Thomas Couvreur
- Wim Hoste
- Wim Lewi
- Jacob Mekhael
MaaT Pharma 1Q25 reiterates pipeline timelines, cash runway into Octob...
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...
- Hilde Van Boxstael
- Jacob Mekhael
- Wim Lewi
- Jacob Mekhael
MaaT Pharma FIRST LOOK: MaaT033 slows disease progression in phase 1 A...
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 ...
- Jacob Mekhael
- Kristof Samoy
- Lynn Hautekeete
- Wim Hoste
- Jacob Mekhael
MaaT Pharma MaaT034 preclinical data at AACR shows potential in solid ...
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...
- Jacob Mekhael
MaaT Pharma Positive DSMB safety analysis for MaaT033 phase 2 in allo-...
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...
- Jacob Mekhael
MaaT Pharma To present preclinical data on MaaT034 at AACR
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...
- Guy Sips
- Jacob Mekhael
- Thomas Vranken
- Wim Hoste
- Guy Sips
- Hilde Van Boxstael
- Jacob Mekhael
- Kristof Samoy
- Lynn Hautekeete
- Sharad Kumar S.P
- Thomas Couvreur
- Thomas Vranken
- Wim Hoste
- Wim Lewi
- Jacob Mekhael
MaaT Pharma FIRST LOOK: FY24 results extend runway with € 13m private ...
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...
- Jacob Mekhael
MaaT Pharma FIRST LOOK: Positive DSMB review for lead product MaaT013 ...
MaaT announced that the independent data safety monitoring board (DSMB) completed its final safety assessment of the pivotal phase 3 (ARES) trial of MaaT013 in 3L aGvHD, which was in line with previous evaluations confirming the favourable benefit/risk ratio of the product. As a reminder, MaaT013 met its primary endpoint in the phase 3 (ARES) trial, and results presented in January 2025 demonstrated a 28 day GI-ORR of 62%, which came in above expectations. Looking ahead, we look forward to the r...
- Guy Sips
- Jacob Mekhael
- Sharad Kumar S.P
MaaT Pharma annonce la conclusion positive de l’examen final du DSMB p...
LYON, France--(BUSINESS WIRE)-- Regulatory News: (EURONEXT : MAAT - la « Société »), société de biotechnologies en stade clinique avancé, leader dans le développement de Microbiome Ecosystem TherapiesTM (MET)1 visant à améliorer la survie des patients atteints de cancers grâce à la modulation du système immunitaire, annonce, après avoir reçu récemment l’approbation de son Plan d'Investigation Pédiatrique (PIP) par le Comité Pédiatrique de l'EMA, que le DSMB a réalisé sa dernière revue de sécurité pour l'essai clinique pivotal de Phase 3 ARES, une étude européenne, ouverte, à un seul bras et ...
MaaT Pharma Announces Positive Outcomes from Final DSMB Meeting for Pi...
LYON, France--(BUSINESS WIRE)-- Regulatory News: (EURONEXT: MAAT – the “Company”), a clinical-stage biotechnology company and a leader in the development of Microbiome Ecosystem TherapiesTM (MET) dedicated to enhancing survival for patients with cancer through immune modulation, announced, after recently receiving the approval of its Pediatric Investigation Plan (PIP) by the EMA Pediatric Committee, that the DSMB completed its final safety assessment of the pivotal Phase 3 trial ARES, a single-arm, open-label, multicenter European study evaluating the efficacy and safety of MaaT013 in acute ...
- Jacob Mekhael
MaaT Pharma MaaT013 PIP approval clears path for MAA submission in Jun...
MaaT announced that the European Medicines Agency (EMA) Pediatric Committee (PDCO) has approved the pediatric investigation plan (PIP) for MaaT013 for the treatment of acute Graft-versus-Host Disease (aGvHD). The approval of the pediatric investigation plan (PIP) for MaaT013 in aGvHD is a positive step for the company as an approved PIP is a prerequisite for filing a marketing authorization application (MAA). As such, MaaT is on track to submit the MAA for MaaT013 in Europe in June 2025, which m...
MaaT Pharma Receives Positive Opinion from EMA Pediatric Committee on ...
LYON, France--(BUSINESS WIRE)-- Regulatory News: (EURONEXT: MAAT – the “Company”), a clinical-stage biotechnology company and a leader in the development of Microbiome Ecosystem TherapiesTM (MET) dedicated to enhancing survival for patients with cancer through immune modulation, announced today that the European Medicines Agency (EMA) Pediatric Committee (PDCO) has approved the Pediatric Investigation Plan (PIP) for MaaT013 for the treatment of acute Graft-versus-Host Disease (aGvHD). “We are very pleased with the productive dialogue with the EMA Pediatric Committee and the positive PIP opi...
MaaT Pharma reçoit un avis positif du Comité Pédiatrique de l'EMA pour...
LYON, France--(BUSINESS WIRE)-- Regulatory News: (EURONEXT : MAAT - la « Société »), société de biotechnologies en stade clinique avancé, leader dans le développement de Microbiome Ecosystem TherapiesTM (MET)1 visant à améliorer la survie des patients atteints de cancers grâce à la modulation du système immunitaire, annonce aujourd'hui que le Comité Pédiatrique (PDCO) de l'Agence européenne des médicaments (EMA) a approuvé le plan d'investigation pédiatrique (PIP) de MaaT013 pour le traitement de la maladie aiguë du greffon contre l'hôte (aGvH). « Nous sommes très satisfaits du dialogue con...
- Hilde Van Boxstael
- Jacob Mekhael
- Sharad Kumar S.P
- Wim Lewi
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