• As of September 30, 2022, cash and cash equivalents were EUR 40.3 million¹
• Revenues of EUR 0.4 million¹ in Q3 2022

Regulatory News:

MaaT Pharma (EURONEXT: MAAT – the “Company”), a French clinical-stage biotech and a pioneer in the development of Microbiome Ecosystem Therapies^TM (MET) dedicated to improving survival outcomes for patients with cancer, today reported its cash position as of September 30, 2022, and its revenues for the third quarter of 2022.

Cash position¹

As of September 30, 2022, total cash and cash equivalents were EUR 40.3 million, as compared to EUR 38.4 million as of June 30, 2022, and EUR 43.3 million as of December 31, 2021. The net increase in cash over the third quarter of 2022 was EUR 1.9 million. This increase reflects:

- Net financing inflows from receipt of funds of EUR 4.3 million in bank loans from CIC and Bpifrance. 

- Receipt of the R&D tax credit related to R&D expenditure for the full year 2021, totaling EUR 2.0 million 

- Financing of operations and ongoing development programs of EUR 4.4 million. 

Revenues in Q3 2022¹

MaaT Pharma reported revenues² from its compassionate access program of EUR 0.4 million for the quarter ended September 30, 2022, and year to date revenues of EUR 0.9 million compared to EUR 0.2 million for same quarter in 2021 and EUR 0.6 million for the 9-months ended September 30, 2021.

Third quarter clinical and operational highlights

Clinical highlights

MaaT013, the lead MET drug candidate for hospital use in an acute setting:

• Phase 3 open label, single arm trial (ARES) for the treatment of acute Graft-versus-Host Disease: in Q3 2022, in addition to France, Germany, Spain, Austria where the trial is ongoing, the Company received regulatory approvals in Belgium. An interim review of preliminary data after enrollment of half of the patients in the study is expected in the first half of 2023.
• Randomized, placebo-controlled proof-of-concept Phase 2a trial (PICASSO), sponsored by AP-HP³, evaluating MaaT013 in combination with immune checkpoint inhibitors for patients with metastatic melanoma, is ongoing. A first internal data review focusing on safety and some biomarker data is expected in the first half of 2023.
• In the US, interactions with the U.S. Food and Drug Administration (FDA) remain active regarding MaaT013, for which US development is currently on clinical hold following an FDA communication received in August 2022 requiring additional information on the safety and efficacy of the Company’s “pooling” approach.
• Pursuit of the Early Access Program in Europe in place since 2021 allowing patients to benefit from early access to the MaaT013 therapy, mainly for the treatment of acute Graft-vs-host-Disease. As of today, the Company has safely treated over 160 patients with MaaT013 in Europe.
• On November 3, 2022, MaaT Pharma announced the release of an abstract, which was selected for an oral presentation at the American Society of Hematology (ASH) 2022 Annual Meeting from December 10-13 in New-Orleans, Louisiana, U.S.A. The oral presentation will occur on December 10, 2022; 10:15am EST and will detail consolidated results from 81 patients with steroid-resistant, gastrointestinal, acute Graft-versus-Host-Disease (GI-aGvHD) treated with MaaT013 as salvage therapy, as part of the ongoing Early Access Program (EAP). 
  
  Link to abstract here.

MaaT033, the Company’s first MET for oral administration as adjunctive and maintenance treatment for patients receiving allogeneic hematopoietic stem cell transplantation (allo-HSCT):

• Preparations are ongoing for a pivotal Phase 2b trial to evaluate MaaT033’s safety and efficacy in improving overall survival and preventing complications in patients with blood cancers receiving allo-HSCT; based on current plans, the Company expects to initiate the study in Q4 2022.
• On November 3rd, 2022, MaaT Pharma announced the release of an abstract, which was selected for a poster presentation at the American Society of Hematology (ASH) 2022 Annual Meeting. Poster presentation will occur on December 11, 2022: 6:00pm - 8:00pm EST and will present detailed results from the Phase 1b clinical trial (CIMON) of MaaT033 in patients with acute myeloid leukemia. 
  
  Link to abstract here.

Operational highlight

• On October 4^th, 2022, MaaT Pharma appointed Dr. Nathalie Corvaïa as Chief Scientific Officer to oversee the Company’s non-clinical R&D strategies and its proprietary, AI-based MET drug design and development platform, gutPrint^®.

Upcoming scientific conferences participation

• November 8-10, 2022 – 9^th International Human Microbiome Consortium (IHMC) Congress – Kobe, Japan: Hervé Affagard, CEO and cofounder of MaaT Pharma, and Dr. Aurore Duquenoy, R&D specialist at MaaT Pharma will present three scientific posters at the conference. 
  
  Link to the Congress here.

• November 9-11, 2022 – 21^st Société Francophone de Greffe de Moelle et de Thérapie Cellulaire (SFGM-TC) Congress – Booth #10 – Bordeaux, France: Dr. Emilie Plantamura, Head of Clinical Development at MaaT Pharma and Claire de Condé, Head of Clinical Operations at MaaT Pharma, and Mélanie Tilte, Clinical Project Manager at MaaT Pharma will attend the congress and will be available for discussions at MaaT Pharma’s booth #10. 
  
  Link to the event here.

Upcoming investor conferences participation

• November 14, 2022 – 7^th annual conference LSX Inv€$tival Showcase – London, UK: Siân Crouzet, Chief Financial Officer of MaaT Pharma and Dr. Carole Schwintner, Chief Technology Officer of MaaT Pharma will attend the investor event and participate in the European Lifestar Awards, where MaaT Pharma is a finalist for the IPO of the year category. 
  
  Additional information available on the LSX website here.
• November 15-17, 2022 – 13^th Annual Jefferies London Healthcare Conference – London, UK: Siân Crouzet, Chief Financial Officer of MaaT Pharma and Dr. Carole Schwintner, Chief Technology Officer of MaaT Pharma will attend the conference.
• November 21, 2022 – Kepler Cheuvreux Life Sciences Day – Digital: Hervé Affagard, CEO and cofounder of MaaT Pharma will attend the event.
• November 29, 2022 – Investir day – Paris, France: Siân Crouzet, Chief Financial Officer of MaaT Pharma and Dr. Savita Bernal, Chief Business Officer of MaaT Pharma will attend the investor event. 
  
  Additional information available on the dedicated website here.

About MaaT Pharma

MaaT Pharma, 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, MaaT Pharma has launched, in March 2022, a Phase 3 clinical trial for patients with acute GvHD, following the achievement of its proof of concept in a Phase 2 trial. Its powerful discovery and analysis platform, gutPrint^®, supports the development and expansion of its pipeline by determining novel disease targets, evaluating drug candidates, and identifying biomarkers for microbiome-related conditions.

The company’s 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. MaaT Pharma 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.

MaaT Pharma is the first company developing microbiome-based therapies 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’s control. These statements may include, without limitation, any statements preceded by, followed by or including words such as “target,” “believe,” “expect,” “aim,” “intend,” “may,” “anticipate,” “estimate,” “plan,” “project,” “will,” “can have,” “likely,” “should,” “would,” “could” 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’s control that could cause the Company’s actual results or performance to be materially different from the expected results or performance expressed or implied by such forward-looking statements.

1 Unaudited data 

2 Revenues correspond to compensation invoiced in relation to the compassionate access program, as approved by the French National Drug Safety Agency (Agence Nationale de Sécurité du Médicament or ANSM). 

3 AP-HP: Assistance Publique - Hôpitaux de Paris

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