On November 8, 2022 MaaT Pharma (EURONEXT: MAAT – the "Company"), a French clinical-stage biotech and a pioneer in the development of Microbiome Ecosystem TherapiesTM (MET) dedicated to improving survival outcomes for patients with cancer, reported its cash position as of September 30, 2022, and its revenues for the third quarter of 2022 (Press release, MaaT Pharma, NOV 8, 2022, View Source [SID1234623388]).

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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 revenues[2] 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-HP[3], 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) (Free ASH Whitepaper) 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) (Free ASH Whitepaper) 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.

Operationalhighlight

On October 4th, 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 – 9th 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 – 21st 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, 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 – 7th 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.
November 15-17, 2022 – 13th 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.
[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