MaaT Pharma Receives U.S. FDA Response Outlining Path Forward for Investigational New Drug Application for MaaT013 in Patients with Acute Graft-versus-Host Disease and Reports Cash and Revenues for Fourth Quarter 2022 - Seite 2

Separately from the information above, MaaT Pharma reported its cash position as of December 31, 2022, and its revenues for the fourth quarter of 2022.

Cash position¹

As of December 31, 2022, total cash and cash equivalents were EUR 35.2 million, as compared to EUR 40.3 million as of September 30, 2022 and EUR 43.3 million as of December 31, 2021. The net decrease in cash over the fourth quarter 2022 was EUR 5.1 million reflecting financing of operations and the ongoing development programs fully in line with the plans. As announced in a press release on January 24, 2023, the Company has extended its cash runway to end of Q4 2023, as compared to end of Q3 2023 as previously announced.

Revenues in Q4 2023¹

MaaT Pharma reported gross revenues of EUR 0.6 million for the quarter ended December 31, 2022, compared with EUR 0.4 million for the same period of 2021. Full year gross revenues for 2022 amount to EUR 1.4 million compared to EUR 1.0 million in 2021. 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).

About MaaT013

MaaT013 is a standardized, high-richness, high-diversity Microbiome Ecosystem TherapyTM containing ButycoreTM (group of bacterial genera known to produce immuno-regulatory metabolites). It aims to restore the symbiotic relationship between the patient’s functional gut microbiome and their immune system to correct the responsiveness and tolerance of immune functions and reduce steroid-resistant, gastrointestinal-predominant aGvHD. MaaT013 has been granted Orphan Drug Designation by the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA). MaaT013 is an off-the-shelf, healthy-multi-donors-derived product intended for acute, hospital use.

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, 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, gutPrint, supports the development and expansion of its pipeline by determining novel disease targets, evaluating drug candidates, and identifying biomarkers for microbiome-related conditions.