Lyon, France, July 28th, 2022, 6:00 pm CET – 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, today reported its cash position as of June 30, 2022, and its revenues for the second quarter of 2022.
“The second quarter of 2022 saw further progress in our pipeline and the achievement of a crucial milestone for MaaT Pharma. The announcement of data showing a satisfactory safety profile and robust engraftment for MaaT033, our second drug candidate, opens an attractive market opportunity to expand the development to a wider patient population as we focus on preventing complications in patients receiving allo-HSCT[2] and in haematological malignancies overall,” said Hervé Affagard, CEO and co-founder of MaaT Pharma.
Second quarter operational and clinical highlights
Clinical development
- In June 2022, the Company confirmed positive results from its Phase 1b study evaluating MaaT033, the Company’s second drug candidate, in blood cancer patients; the clinical trial was completed early due to promising interim results.
- MaaT Pharma also indicated that preparations are on track for the upcoming Phase 2/3 trial to evaluate MaaT033’s efficacy in improving overall survival and preventing complications in patients with blood cancers receiving allogeneic hematopoietic stem cell transplantation; based on current plans, this study is expected to start in Q4 2022.
- In Europe, MaaT013, the Company’s leading drug candidate, is currently being evaluated in two clinical trials launched in Q1 2022, which are moving forward according to the Company’s expected timelines:
- Phase 3 open label, single arm trial for drug candidate MaaT013 in the treatment of acute Graft-versus-Host Disease: in addition to France, Germany, and Spain where the trial is ongoing, the Company has received regulatory approvals to start the clinical trial in Austria and Belgium. An interim review of preliminary data is expected in the first half of 2023.
- Phase 2a trial, sponsored by AP-HP[3], evaluating MaaT013 in combination with immune checkpoint inhibitors for patients with melanoma, is ongoing.
- In the US, interactions with the U.S. Food and Drug Administration (FDA) are ongoing regarding MaaT013, for which US development is currently on clinical hold.
Operational highlights
- On May 31, 2022, MaaT Pharma held its annual general meeting. For further information, please visit: https://www.maatpharma.com/investors/#GM
- On June 7, 2022, the Company hosted its first virtual R&D Day conference, attended by 150 participants. The replay is accessible here: https://www.maatpharma.com/rd-day-2022-replay/
“Over the first half of 2022 we are proud to have delivered to our shareholders the operational and clinical milestones set out at the time of our IPO. Our cash position remains solid, providing us with a cash runway through Q3 2023 by which time we expect to have interim data from our Phase 3 trial of MaaT013, and the first patient treated with MaaT033 in a Phase 2/3,” stated Siân Crouzet, CFO and COO of MaaT Pharma.
Cash position1
As of June 30, 2022, total cash and cash equivalents were EUR 38.4 million, as compared to EUR 41.1 million as of March 31, 2022, and EUR 43.3 million as of December 31, 2021. The net change in cash over the first half of 2022 was EUR 4.9 million, including EUR 2.7 million in bank loans from BNP Paribas and Caisse d’Epargne Rhone Alpes (CERA) received over the course of the second quarter of 2022. Additional draws down, up to 4.4 million euros, are expected to be made by the end of 2022 from existing facilities signed with CIC and Bpifrance. The Company believes it has sufficient cash to cover needs of the development programs up until the end of the third quarter of 2023.
Revenues in Q2 20221
MaaT Pharma reported revenues[4] from its compassionate access program of EUR 0.2 million for the quarter ended June 30, 2022, compared with EUR 0.3 million for the first quarter of 2022. Total revenues for the first half of 2022 amount to EUR 0.5 million compared with EUR 0.4 million for the first half of 2021. In 2021, revenues were invoiced as of February 2021 whereas in 2022 the Company benefits from a full 6 months of revenues.
Upcoming financial communication and investor conference participation
- September 12-14, 2022 – C. Wainwright 24th Annual Global Investment Conference
- September 15-16, 2022 – KBC Securities Life Sciences Conference
- September 28, 2022 – 5th edition – Forum LPB Valeurs Régionales
- September 29, 2022 – Half-year Results 2022*
- October 6-7, 2022 – Investor Access Event
*Indicative calendar that may be subject to change.
[1] Unaudited data
[2] Allogeneic hematopoietic stem cell transplantation (allo-HSCT) is a curative treatment of liquid tumors which affect approximately 22,000 patients every year in the 7 major markets
[3] AP-HP: Assistance Publique – Hôpitaux de Paris
[4] 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 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 listed on Euronext Paris (ticker: MAAT).
