MaaT Pharma Publishes its Half Year 2024 Results and Provides a Business Update

   -- Positive efficacy and safety data of MaaT013 in aGvHD in the Early Access 
      Program presented at the EBMT 2024 annual meeting with 63% GI-ORR at D28, 
      a 49% one year and 42% 18 months Overall Survival (OS) in patients 
      similar to those included in the ongoing Phase 3 ARES trial. 
 
   -- Completion of patients' recruitment for the Phase 2b PICASSO trial 
      sponsored by AP-HP evaluating MaaT013 in combination with immune 
      checkpoint inhibitors $(ICI.AU)$ in metastatic melanoma. 
 
   -- MaaT013 batches manufactured and ready to be distributed for clinical 
      supply in the US and in Europe and advancement of the readiness phase for 
      the initiation of clinical activities. 
 
   -- Positive review by an independent Data Safety and Monitoring Board (DSMB) 
      of the Phase 2b PHOEBUS trial evaluating MaaT033 for patients with blood 
      cancers undergoing allo-HSCT, which recommended that the trial proceeds 
      as planned without modification. 
 
   -- Successful raise of EUR17.3 million in net proceeds upon completing an 
      offering in May 2024. 
 
   -- As of June 30, 2024, cash and cash equivalents were EUR31.2 million, 
      anticipated cash runway extended into Q2 2025 after prioritization of 
      resources around the delivery of Phase 3 topline results for MaaT013 in 
      Europe. 
 
   -- Revenues of EUR1.7 million in H1 2024, compared to EUR1.4 million in H1 
      2023, linked to a continuous increase in demand for MaaT013 in the Early 
      Access Program. 
LYON, France--(BUSINESS WIRE)--September 19, 2024-- 

Regulatory News:

MaaT Pharma (EURONEXT: MAAT -- the "Company"), a clinical-stage biotechnology company and a leader in the development of Microbiome Ecosystem Therapies$(TM)$ $(MET)$ dedicated to enhancing survival for patients with cancer through immune modulation, today announced its half year financial results for the six-month period ended June 30, 2024, and provided a business overview.

"Building on the positive data for MaaT013 in April 2024 presented at the EBMT Congress, and the success of our recent fundraising, we have dedicated the first half of 2024 to pursuing recruitment and preparing for the topline results of our ongoing Phase 3 clinical trial for MaaT013. This trial is designed to address the urgent unmet medical need of patients with acute graft-versus-host disease not responding to current treatments. Currently, patients requiring third-line treatment options face an 85% mortality rate within one year. Furthermore, by extending our cash runway by an additional quarter, we are well-positioned to deliver on our short-term milestones," stated Siân Crouzet, Chief Financial Officer of MaaT Pharma.

Pipeline Highlights

MET-N platform

MaaT013

   -- In hemato-oncology: 
 
          -- In March 2024, the Company announced the launch of a retrospective 
             multicenter trial called CHRONOS in Europe. Its primary objective 
             is to provide the Company efficacy data for 3rd-line therapies for 
             aGvHD patients not receiving MaaT013 or any microbiome 
             intervention. This retrospective study does not impact cash 
             projections as funding is already secured. 
 
          -- In April 2024, at the 50th Annual Meeting of the European Society 
             for Blood and Marrow Transplantation $(EBMT)$, the Company presented 
             promising extended survival data from the Early Access Program in 
             Europe, involving 140 patients with steroid-refractory $(SR)$ or 
             steroid-dependent $(SD)$ acute graft-versus-host disease with 
             gastrointestinal involvement (GI-aGvHD) treated with MaaT013. Data 
             highlighted a high response rate (Complete Response and Very Good 
             Partial Response) to MaaT013, demonstrating a clear reduction in 
             disease burden and improved Overall Survival (OS) at 18 months 
             compared to published data. 
 
   -- In immuno-oncology: 
 
          -- In March 2024, the Company informed on the completion of patient 
             recruitment for the Phase 2a randomized clinical trial 
             (NCT04988841) (PICASSO) sponsored by AP-HP and in collaboration 
             with INRAE and Institut Gustave Roussy, evaluating MaaT013 in 
             combination with immune checkpoint inhibitors (ICI), ipilimumab 
             (Yervoy$(R)$) and nivolumab (Opdivo(R)), in metastatic melanoma 
             patients. A total of 70 patients have been enrolled since April 
             2022. The Company provided its MaaT013 drug candidate and placebo 
             and will contribute to the microbiome profiling of patients using 
             its proprietary gutPrint(R) AI research engine. As previously 
             announced, data readout is expected in Q4 2024/Q1 2025. 

MaaT033

   -- In hemato-oncology: 
 
          -- In May 2024, the Company announced its participation in the 
             IMMUNOLIFE RHU program, a consortium including academic partners, 
             such as Institut Gustave Roussy $(IGR)$, a world-renowned center in 
             the field of cancer treatment, and biotech companies. MaaT033, an 
             oral, pooled fecal microbiotherapy, developed by MaaT Pharma will 
             be tested as a concomitant treatment to cemiplimab (Regeneron), an 
             anti-PD1 therapy, to assess the potential increase in response 
             rate in patients having received antibiotics. This randomized 
             multicenter Phase 2 clinical trial will include advanced non-small 
             cell lung cancer (NSCLC) patients. The related costs for MaaT 
             Pharma are limited to clinical product supply in line with 
             previous cash projections. The trial is expected to start in H1 
             2025. 
 
          -- As a post-period event, in July 2024, the Company announced first 
             DSMB positive review of the Phase 2b trial PHOEBUS and recommended 
             continuation of the trial without modification. The DSMB concluded 
             that the safety profile was acceptable and the treatment 
             well-tolerated. The trial is an international, multi-center, 
             randomized, double-blind, testing MaaT033, in patient receiving 
             HSCT, an oral freeze-dried formulation against placebo, set to be 
             conducted in up to 56 clinical investigation sites and is expected 
             to enroll 387 patients (NCT05762211). 
 
          -- Recruitment for PHOEBUS trial is ongoing in France, Germany, Spain, 
             and Belgium, with the trial already approved in the Netherlands 
             and the United Kingdom. Upcoming milestones include a second 
             safety assessment by the DSMB expected in early Q1 2025. The 
             interim analysis following the recruitment of 60 patients, is 
             expected in H1 2025, instead of H2 2024. This slight delay is due 
             to the strategic option taken by the Company's management in early 
             2024 to prioritize resources for the Phase 3 ARES trial and open 
             new trial sites in countries outside France and Germany in a more 
             sedate manner than originally planned. 
 
   -- In neurodegenerative diseases: 
 
          -- In February 2024, the Company announced a positive review by the 
             DSMB on the Phase 1 clinical trial (IASO) evaluating MaaT033 in 
             Amyotrophic Lateral Sclerosis (ALS) for the first 8 patients. The 
             DSMB recommended that the trial proceed without modification. 
 
          -- In May 2024, the Company announced the completion of patient 
             recruitment for IASO. 

MET-C platform

MaaT034

   -- In combination with immune checkpoint inhibitors in solid tumors 
 
          -- In April 2024, the Company presented new in vitro data 
             characterizing the metabolites produced by MaaT034 and their 
             impact on immune modulation at the American Association for Cancer 
             Research (AACR) Annual Meeting 2024 in San Diego, California. 
             MaaT034, the first product from MaaT Pharma's MET-C platform, is a 
             ground-breaking full ecosystem synthetic microbiota product being 
             developed for patients with solid tumors to improve responses to 
             immunotherapy in combination with an ICI treatment, which 
             represents a potentially large market. In today's challenging 
             economic environment, the Company has prioritized resources to 
             focus on MaaT013, specifically preparing marketing authorization 
             activities in Europe and the upcoming Phase 3 topline results in 
             Europe. This approach aimed at optimizing both short-term 
             validation and clinical validation, has resulted in a deferral of 
             activities related to MaaT034. Thus, clinical activities for 
             MaaT034 are now expected to begin in 2026 and not 2025, as 
             previously announced. 

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