黑料社

黑料社 Provides a Business Update and Highlights Key Milestones Expected in 2024

Lyon, France, May 7 2024 鈥�6.30 pm CET 鈥� 黑料社 (EURONEXT: MAAT 鈥� the 鈥淐ompany鈥�), a clinical-stage biotech company and a leader in the development of Microbiome Ecosystem Therapies^TM (MET) dedicated to improving survival outcomes for patients with cancer,today provided a business update and highlights its key milestones for 2024.

Herv茅 Affagard, CEO and co-founder of 黑料社 said: 鈥淲e’re confidently advancing towards Phase 3 results for MaaT013, meeting milestones and delivering value for shareholders. Recent data at the EBMT annual congress underscores MaaT013’s potential in aGvHD where therapeutic options are insufficient. We are also thrilled to partner with Institut Gustave Roussy (IGR), a world-renowned center in cancer treatment to explore MaaT033’s impact on immune checkpoint inhibitors鈥� response in non-small cell lung cancer patients, and therefore deepening our development in immuno-oncology. This collaboration further strengthens 黑料社鈥檚 leading position in oncology and the medical community鈥檚 interest in microbiome drug candidates.鈥�

听Pipeline highlights

MET-N

MaaT013

• In hemato-oncology:
  • In March 2024, the Company announced the launch of a retrospective multicenter trial called CHRONOS in Europe. Its objective is to provide the Company efficacy data for 3rd-line therapies for patients not receiving MaaT013 or any microbiome intervention. This study was not requested by regulatory authorities and does not impact cash projections as funding has already been secured.
  • In April 2024, at the 50^th annual meeting of the European Society for Blood and Marrow Transplantation (EBMT), the Company presented positive efficacy and safety results in 140 patients treated with MaaT013 in acute graft-versus-host disease (aGvHD) as part of the Early Access Program (EAP). The data presented demonstrates a clear reduction in disease burden and an improved Overall Survival (OS), and highlighted MaaT013’s good safety profile. The results in the 49-patient 鈥淎RES-like鈥� subgroup, with the same characteristics as those of the Phase 3 ARES trial (NCT04769895) demonstrated 63% GI-ORR at D28 and Overall Survival (OS) of 49% at one year and 42% at 18 months. This represents a significant increase when compared with the historical data published by Abedin et al. (used by the medical community as the most recent reference) which showed a limited 15% OS at one year in a similar population.
  • Primary endpoint readout, GI-ORR at D28, of the ARES Phase 3 clinical trial in aGvHD is expected for mid Q4-2024.

• In immuno-oncology:
  • In March 2024, the Company informed on the completion of patient recruitment for the Phase 2a clinical trial PICASSO (NCT04988841) sponsored by AP-HP and in collaboration with INRAE and Institut Gustave Roussy, evaluating MaaT013 in combination with Immune Checkpoint Inhibitors (ICI). Topline results expected in Q4 2024/Q1 2025.

MaaT033

• In immuno-oncology:
  • 黑料社 announces its participation in the IMMUNOLIFE RHU[1] 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. IMMUNOLIFE aims to solve the significant problem of primary resistance to immune checkpoint inhibitors (ICI) observed in advanced non-small cell lung cancer (NSCLC) patients following antibiotic uptake. MaaT033, an oral, pooled fecal microbiotherapy, developed by 黑料社 will be tested as a concomitant treatment to anti-PD1 therapy to increase the ICI response rate in this Phase 2 randomized multicenter clinical trial including advanced NSCLC patients. Participation in this programwill also grant access to clinical and metagenomic data from听a large cohort of cancer patients (bladder, lung and renal) which will be used to improve 黑料社鈥檚 artificial intelligence (AI) 驳耻迟笔谤颈苍迟庐 platform. The related costs for 黑料社 are limited to clinical product supply in line with previous cash projections.

• In neurodegenerative diseases:
  • In February 2024, the Company announced that the Data Safety and Monitoring Board (DSMB) reviewed safety data in the first 8 patients with Amyotrophic Lateral Sclerosis (ALS) treated with MaaT033 in the Phase 1 clinical trial IASO (). The DSMB, composed of 4 independent experts, including an ALS patient association representative, concluded that safety was good and recommended that the trial continue without modifications.
  • 黑料社 announces the completion of patient recruitment for IASO.

MET-C

MaaT034

• In immuno-oncology:
  • In April 2024, at the American Association for Cancer Research (AACR) Annual Meeting 2024 in San Diego, California, the Company presented characterizing the metabolites produced by MaaT034 and their impact on immune modulation. MaaT034 may be the first full-co-cultivated ecosystem therapy for immuno-oncology, combining a diverse array of supportive species with functional networks of interest to improve the response to immune checkpoint inhibitors. The results demonstrate that MaaT034 produced key metabolites, recognized as promoting gut barrier restoration and modulating immune responses. This represents a significant advancement in understanding the mechanism of action (MoA) of co-cultured microbiome therapies developed by 黑料社 marking a major step towards clinical evaluation.

Corporate update

• In March 2024, the Company announced the appointment of Jonathan Chriqui, PharmD, as Chief Business Officer and member of the executive management team. Jonathan will be responsible for 黑料社鈥檚 business development and partnering strategies, increasing the Company鈥檚 ability to secure partnership deals, in line with its strategic objectives.
• 黑料社 has engaged in active discussions with prominent US clinicians in the field of stem cell transplantation to explore the most efficient path forward to introduce MaaT013 to patients in the United States. The Company is pleased to announce the production of batches of MaaT013 destined for clinical supply in the US as the Company pursues the readiness phase in advance of clinical study initiation.
• The Company believes it has sufficient cash to finance operations to the end of Q3 2024. While the Company does not have sufficient cash to finance its operations for the next twelve months, it has active ongoing discussions to finance operations beyond the end of Q3 2024 and remains confident in extending its cash runway.

Key value creation milestones in 2024

• MaaT013
  • Mid-Q4: Primary endpoint readout (GI-ORR at D28) from the ARES Phase 3 clinical trial in aGvHD
  • Q4 2024/Q1 2025: Topline results of the PICASSO Phase 2a clinical trial in metastatic melanoma
• MaaT033
  • H2 2024: First DSMB^[2] of the PHOEBUS Phase 2b clinical trial in allo-HSCT
  • H2 2024: Results of the IASO Phase 1 clinical trial in ALS
• MaaT034
  • H1 2024: Candidate selection
  • H2 2024: Start of the production of the first cGMP batch

Upcoming investor and business conferences participation

• June 3-6, 2024 鈥� BIO 2024
• June 11-12, 2024 鈥� Portzamparc Mid & Small Caps 2024 Conference
• June 25-27, 2024 鈥� Stifel European Healthcare Summit Lyon
• July 10-12, 2024 鈥� Microbiome Movement Drug Development Summit

听

[1] Contract N掳 ANR-21-RHUS-0017 鈥� RHU stands for Recherche Hospitalo-Universitaire – University Hospital Research

[2] at the recruitment of 60 patients

About 黑料社

黑料社, a clinical stage biotechnology company, has established a complete approach to restoring patient-microbiome symbiosis in oncology. Committed to treating cancer and graft-versus-host disease (GvHD), a serious complication of allogeneic stem cell transplantation, 黑料社 has launched, in March 2022, an open-label, single arm Phase 3 clinical trial in patients with acute GvHD, following the achievement of its proof of concept in a Phase 2 trial. Its powerful discovery and analysis platform, 驳耻迟笔谤颈苍迟庐, enables the identification of novel disease targets, evaluation of drug candidates, and identification of biomarkers for microbiome-related conditions. The company鈥檚 Microbiome Ecosystem Therapies are produced through a standardized cGMP manufacturing and quality control process to safely deliver the full diversity of the microbiome, in liquid and oral formulations. 黑料社 benefits from the commitment of world-leading scientists and established relationships with regulators to support the integration of the use of microbiome therapies in clinical practice. 黑料社 is listed on Euronext Paris (ticker: MAAT).

Forward-looking Statements

All statements other than statements of historical fact included in this press release about future events are subject to (i) change without notice and (ii) factors beyond the Company鈥檚 control. These statements may include, without limitation, any statements preceded by, followed by or including words such as 鈥渢arget,鈥� 鈥渂elieve,鈥� 鈥渆xpect,鈥� 鈥渁im,鈥� 鈥渋ntend,鈥� 鈥渕ay,鈥� 鈥渁nticipate,鈥� 鈥渆stimate,鈥� 鈥減lan,鈥� 鈥減roject,鈥� 鈥渨ill,鈥� 鈥渃an have,鈥� 鈥渓ikely,鈥� 鈥渟hould,鈥� 鈥渨ould,鈥� 鈥渃ould鈥� and other words and terms of similar meaning or the negative thereof. Forward-looking statements are subject to inherent risks and uncertainties beyond the Company鈥檚 control that could cause the Company鈥檚 actual results or performance to be materially different from the expected results or performance expressed or implied by such forward-looking statements.