Latest news with #MaaT013
Yahoo
3 days ago
- Business
- Yahoo
MaaT Pharma Advances Toward Commercialization And Submits Marketing Authorization Application to the European Medicines Agency (EMA) for Xervyteg® (MaaT013) in Acute Graft-versus-Host Disease
MaaT Pharma submitted today a Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) for its product candidate MaaT013, under the registered brand name of Xervyteg®. Xervyteg® has the potential if approved, to become the first microbiota therapeutic approved by the EMA and the first one in hemato-oncology globally. The MAA submitted to the EMA is based on data from the Pivotal ARES study, evaluating the safety and efficacy of Xervyteg® in adult patients with acute Graft-versus-Host Disease including gastro-intestinal involvement who received two prior lines of therapy and supported by data from the ongoing Early Access Program. MaaT Pharma prepares for a potential 2026 commercial launch through a strategic partnership to address this key unmet need in hemato-oncology. LYON, France, June 02, 2025--(BUSINESS WIRE)--Regulatory News: MaaT Pharma (EURONEXT: MAAT – the "Company"), a clinical-stage biotechnology company and a leader in the development of Microbiome Ecosystem TherapiesTM (MET) dedicated to enhancing survival for patients with cancer through immune modulation, today announced the submission of the Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) for its lead drug candidate MaaT013, under the registered brand name of Xervyteg®. If approved, the Marketing Authorization would establish Xervyteg® as the first microbiota therapeutic approved by the EMA, and the first one globally for a hematology indication. Xervyteg® would also be the first approved therapy for the treatment of acute Graft-versus-Host Disease including gastro-intestinal involvement (GI-aGvHD) following 2 prior lines of systemic therapy. "Submitting our MAA to the EMA marks a major regulatory milestone for MaaT Pharma and a meaningful advancement for patients with refractory aGvHD—a life-threatening complication of stem cell transplantation with no approved therapies," said Hervé Affagard, Co-founder and CEO of MaaT Pharma. "We are now closer to providing a much-needed treatment option and remain deeply committed to advancing immunomodulating microbiota technologies in hemato-oncology, where new solutions are urgently needed." While advancing toward the commercialization of Xervyteg® (if approved) in Europe, MaaT Pharma is also actively exploring strategic partnerships to ensure broad access in timely fashion. The Company has active discussions with experienced partners who share its mission of delivering meaningful advancements to patients. In parallel to the MAA submission, MaaT Pharma continues to provide access to Xervyteg® in Europe and the U.S. through its Early Access Program (EAP)1 for patients with aGvHD and other indications. In 2024, physician demand for Xervyteg® under the EAP (n=107) increased by 75% compared to 2023, driven by growing adoption across Europe and in the U.S. In France where the EAP first started, MaaT Pharma has captured 25% of the addressable market on a yearly basis in 2024. Overall, this position reflects the increasing recognition of Xervyteg® as a valuable treatment option for GI-aGvHD patients. aGvHD is the most severe complication of allogeneic stem cell transplantation, a standard-of-care treatment with curative intent offered to patients with blood cancers and some non-malignant hematological conditions. aGvHD refractoriness to current treatments is frequently encountered and severely impacts prognosis. In particular, patients with aGvHD failing both steroid and ruxolitinib typically exhibit a dismal prognosis, with a median survival of 28 days and 85% mortality at one year (Abedin et al 2021). Currently, no therapy is approved for third-line aGvHD, underscoring the urgent need for innovative therapies capable of improving survival and quality of life. The MAA is supported by positive results from the Pivotal ARES study, a single-arm, open-label, multicenter European study evaluating the efficacy and safety of Xervyteg® in GI-aGvHD as third-line therapy in 66 patients. Notably, the study met its primary endpoint, achieving a gastrointestinal overall response rate (GI-ORR) of 62% at Day 28, significantly exceeding the expected 38% response rate, and an overall response rate across all organs of 64% at Day 28. Among responding patients at Day 28, the majority exhibited full resolution of GvHD clinical manifestations (i.e., complete response), an important finding predictive of durable control of aGvHD clinical manifestations over time. The 12-month probability of survival was 54% (vs 15% Abedin et al, 2021). Importantly, patients who exhibited gastrointestinal response at Day 28 had a significantly better probability of survival than non-responders (67% vs 28% respectively, p <0.0001), indicating that Xervyteg®-mediated aGvHD control is associated with a remarkable survival benefit. Additional secondary endpoints, including overall survival, will become available in late H2 2025. The Company also integrated supporting safety and efficacy data from 186 aGvHD patients2 treated under its ongoing EAP, which aligns with the positive topline results of the ARES trial and further supports Xervyteg®'s strong efficacy and favorable safety profile in aGvHD. The safety and tolerability of Xervyteg® has been monitored by an independent Data Safety Monitoring Board (DSMB). In March 2025, the DSMB reviewed the overall safety of the trial (after all patients completed Day 28 visit or were discontinued earlier) and confirmed that "given the remarkable efficacy results, the study results show an acceptable safety profile and a favourable benefit /risk ratio". The DSMB members will continue to review safety on an ongoing basis until the 1-year follow-up. The EMA will review the application under the centralized marketing authorization procedure and potentially a marketing authorization could be granted in H2 2026. This centralized procedure means that a single marketing authorization application can be submitted to the EU, and if granted by the European Commission, the authorization is valid in all EU Member States as well as in the European Economic Area (EEA) countries Iceland, Liechtenstein and Norway. About acute Graft-versus-Host Disease Acute Graft-versus-Host Disease occurs in patients within 100 days of undergoing a stem cell or bone marrow transplant, where the transplanted cells initiate an immune response and attack the transplant recipient's organs, causing inflammation of the skin, liver and/or gastro-intestinal tract and leading to significant morbidity and mortality. GI involvement is associated with severe complications such as profound diarrhea, abdominal pain, intestinal bleeding, and death. These complications are often life-threatening, with increased mortality risk, due to the challenges of managing severe GI inflammation and the associated risks of infection, malnutrition, and organ failure. The standard first line therapy for treating aGvHD is the use of systemic steroids. If patients do not respond to steroids, they are considered Steroid Resistant (SR) and other agents can be administered. Currently the only agent approved for treating SR aGvHD after failure of steroid treatment is ruxolitinib, which is currently approved for this indication in USA and has received approval from the European Medical Agency's Committee for Human Medicinal Products (CHMP) on March 25, 2022. About Xervyteg® (MaaT013) MaaT Pharma's Microbiome Ecosystem Therapies (MET) are designed to leverage a full microbiome ecosystem to restore balance and maximize clinical benefits for patients with severe, treatment-induced dysbiosis in acute diseases. Xervyteg® (MaaT013) is a full-ecosystem, off-the-shelf, standardized, pooled-donors, enema Microbiome Ecosystem TherapyTM for acute, hospital use. It is characterized by a consistently high diversity and richness of microbial species and the presence of ButycoreTM (a group of bacterial species known to produce anti-inflammatory metabolites). Xervyteg® (MaaT013) 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 thus reduce steroid-resistant, gastrointestinal (GI)-aGvHD. Xervyteg® (MaaT013) has been granted Orphan Drug Designation by the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA). About MaaT Pharma MaaT Pharma is a leading, late-stage clinical company focused on developing innovative gut microbiome-driven therapies to modulate the immune system and enhance cancer patient survival. Supported by a talented team committed to making a difference for patients worldwide, the Company was founded in 2014 and is based in Lyon, France. As a pioneer, MaaT Pharma is leading the way in bringing the first microbiome-driven immunomodulator in oncology. Using its proprietary pooling and co-cultivation technologies, MaaT Pharma develops high diversity, standardized drug candidates, aiming at extending life of cancer patients. MaaT Pharma has been listed on Euronext Paris (ticker: MAAT) since 2021. 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 Updated data from the Early Access Program will be presented at the EHA Annual Congress in Milan, June 12–16, 20252 The cutoff date was October 3, 2024 View source version on Contacts MaaT Pharma – Investor RelationsGuilhaume DEBROAS, of Investor Relations+33 6 16 48 92 50invest@ Rx Communications Group –U.S. Investor RelationsMichael MillerManaging Director+1-917-633-6086mmiller@ MaaT Pharma – Media RelationsPauline RICHAUDSenior PR & Corporate Communications Manager+33 6 14 06 45 92media@ Catalytic Agency –U.S. Media RelationsHeather SheaMedia relations for MaaT Pharma+1 Error in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data
Business Wire
14-05-2025
- Business
- Business Wire
MaaT Pharma To Present Updated Data for MaaT013 in Early Access Program at the European Hematology Association (EHA) Annual Congress
LYON, France--(BUSINESS WIRE)--Regulatory News: MaaT Pharma (EURONEXT: MAAT – the 'Company'), a clinical-stage biotechnology company and a leader in the development of Microbiome Ecosystem Therapies TM (MET) dedicated to enhancing survival for patients with cancer through immune modulation, today announced that updated data from its Early Access Program for 173 patients with aGvHD treated with MaaT013 have been selected for oral presentation at the European Hematology Association (EHA) Annual congress, taking place in Milan from June 12–15, 2025. The oral presentation of MaaT013 data at EHA—Europe's leading hematology conference—underlines the growing recognition of the drug's clinical potential and the Company's leadership in hemato-oncology using microbiome-based approach. These updated EAP results for 173 patients, to be presented at EHA Congress, are consistent with the positive topline results of the Phase 3 trial announced in January 2025 and further confirm MaaT013's high efficacy and favorable safety profile in treating patients with gastrointestinal aGvHD. There are currently no approved options for patients with GI-aGvHD who are refractory to steroids and either refractory or intolerant to ruxolitinib, despite the poor prognosis with one-year survival rates of 15% (Abedin et al., 2021). MaaT Pharma has observed a 75% increase in physician demand with MaaT013 under the ongoing EAP in 2024 compared to 2023, across Europe and, more recently, in the United States. This steady demand for access to MaaT013 reflects its growing adoption by the medical community as a treatment option for patients with GI-aGvHD. To date, the Company has safely treated more than 300 patients with aGvHD across clinical trials and the Company's EAP ongoing in both Europe and the U.S. With upcoming regulatory milestones in Europe including a Marketing Authorization submission expected in June 2025, growing global physician interest, and continued clinical validation, MaaT013 has the potential to become the first approved third-line treatment for GI-aGvHD, significantly improving survival outcomes for approximately 3,000 third-line patients annually across the U.S., Canada, and Europe. Details of the Oral Presentation: Title: Pooled Fecal Allogeneic Microbiotherapy for Refractory Gastrointestinal Acute Graft-Versus-Host Disease: Results from the Early Access Program in Europe Abstract number: S260 Presenting Author: Mohamad Mohty, Professor of Hematology and Head of the Hematology and Cellular Therapy Department at Saint-Antoine Hospital and Sorbonne University Session title: s424 Stem cell transplantation - Session 2 Date & Time: 13/06/2025 (17:00 - 18:15 CEST) - Brown Hall 3 MaaT Pharma will also present its ongoing Phase 2b trial (PHOEBUS) design for MaaT033 developed as an adjunctive therapy to enhance overall survival in allo-HSCT. This international, multi-center trial (NCT05762211) is the largest randomized controlled study to date of a microbiome-based therapy in oncology, enrolling up to 387 patients across 60 sites. To date, the independent Data Safety Monitoring Board (DSMB) has conducted two safety reviews and one unblinded interim analysis, all of which concluded positively with the recommendation that the PHOEBUS trial proceed as planned. About MaaT Pharma MaaT Pharma is a leading, late-stage clinical company focused on developing innovative gut microbiome-driven therapies to modulate the immune system and enhance cancer patient survival. Supported by a talented team committed to making a difference for patients worldwide, the Company was founded in 2014 and is based in Lyon, France. As a pioneer, MaaT Pharma is leading the way in bringing the first microbiome-driven immunomodulator in oncology. Using its proprietary pooling and co-cultivation technologies, MaaT Pharma develops high diversity, standardized drug candidates, aiming at extending life of cancer patients. MaaT Pharma has been listed on Euronext Paris (ticker: MAAT) since 2021. 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.
Business Wire
13-05-2025
- Business
- Business Wire
MaaT Pharma Provides Business Update and Reports Financial Results for the First Quarter 2025
LYON, France--(BUSINESS WIRE)--Regulatory News: The first months of 2025 have marked a pivotal moment for MaaT Pharma with the positive results from our Phase 3 trial of MaaT013, our lead asset. Share MaaT Pharma (EURONEXT: MAAT – the 'Company'), a clinical-stage biotechnology company and a leader in the development of Microbiome Ecosystem Therapies TM (MET) dedicated to enhancing survival for patients with cancer through immune modulation, today provided a business update and reported its cash position as of March 31, 2025. 'The first months of 2025 have marked a pivotal moment for MaaT Pharma with the positive results from our Phase 3 trial of MaaT013, our lead asset. This milestone enables us to advance toward a Market Authorization submission in Europe and reflects over a decade of dedication and close collaboration with physicians. We are deeply grateful for the trust and participation of patients, whose support has been essential in achieving this progress,' said Hervé Affagard, CEO and co-founder of MaaT Pharma. 'We are also making strong progress across our pipeline, with encouraging outcomes for MaaT033 and MaaT034. Additionally, by extending our cash runway to October 2025, we are well-positioned to deliver on our upcoming value-creating milestones.' Pipeline highlights In Hemato-Oncology Acute Graft-versus-Host Disease (aGvHD) – MaaT013 In January 2025, the Company announced positive topline results from the pivotal Phase 3 ARES Study evaluating MaaT013 in aGvHD. The study met its primary endpoint with a significant gastrointestinal overall response rate at Day 28 of 62% and demonstrates the unprecedented efficacy of MaaT013 as third-line treatment of aGvHD with gastrointestinal involvement (GI-aGvHD) consistent with previously communicated EAP results. The Company anticipates MAA submission in Europe in June 2025. In March 2025, the Company received positive opinion from EMA Pediatric Committee on the Pediatric Investigation Plan for MaaT013, a key milestone achieved towards the MAA submission to the EMA. In March 2025, the Company received a positive outcome from the final DSMB meeting on ARES Phase 3 trial, confirming the remarkable efficacy results and positive risk/benefit profile of MaaT013 in third-line aGvHD. Earlier this year, the Company announced its intent to partner the distribution of MaaT013 in Europe, while retaining MaaT013 rights in the U.S. Allogenic Hematopoietic Stem Cell Transplant (allo-HSCT) - MaaT033 In January 2025, the Company announced that the DSMB completed its second safety assessment of the Phase 2b trial PHOEBUS and recommended continuation of the trial without modification. In April 2025, the Company announced the positive outcome of a key DSMB safety interim analysis for the Phase 2b trial PHOEBUS. As a result of their unblinded analysis, the DSMB recommended the trial to proceed as planned, showing no excessive mortality related to MaaT033 as of today. This additional positive outcome further reinforces MaaT033's safety profile and supports MaaT033's integration in the allo-HSCT setting without significant risks of severe adverse events. In Immuno-Oncology MaaT034 - Next-generation drug candidates with co-cultured technology (MET-C platform) In April 2025, MaaT Pharma presented promising preclinical data for MaaT034 at the American Association for Cancer Research (AACR) Annual Meeting 2025, demonstrating strong anti-tumor efficacy and immune activation in germ-free mice. MaaT013– Proof-of-Concept trials with donor derived drugs (MET-N platform) MaaT013 is currently being evaluated in a Phase 2a randomized clinical trial (NCT04988841) (PICASSO) sponsored by AP-HP and in collaboration with INRAE and Institut Gustave Roussy, in combination with immune checkpoint inhibitors (ICI), ipilimumab (Yervoy®) and nivolumab (Opdivo®), in metastatic melanoma patients. The Company provided its MaaT013 drug candidate and placebo and contributes to the microbiome profiling of patients using its proprietary gutPrint® AI research engine, while the trial investigator sponsor handled recruitment, treatment and oversee data collection and analysis. Data readout is expected in H2 2025. In Neurodegenerative Diseases Amyotrophic Lateral Sclerosis (ALS) - MaaT033 In May 2025, MaaT Pharma announced positive final Phase 1b results for MaaT033 in ALS, showing a favorable safety and tolerability profile supported by biomarker and microbiome analyses. Rapid and sustained microbial engraftment was observed, along with a slower rate of disease progression (ALSFRS-R slope to be interpreted with caution. The Company is seeking a partner to further advance clinical evaluation in ALS. Corporate update In April 2025, the Company announced the initiation of coverage of its stock by H.C. Wainwright & Co. With a research report named ' In With the Gut and Out With the Bad in GvHD; Initiating at Buy With a €21 PT', H.C. Wainwright & Co initiated a Buy recommendation and a Target Price of €21. Cash position 1 As of March 31, 2025, total cash and cash equivalents were EUR 24.4 million, as compared to EUR 20.2 million as of December 31, 2024. The net increase in cash position of EUR 4.2 million during the first quarter of 2025 includes the capital increase of €13 million supported by historical shareholders, while investment in R&D activities continued across the pipeline. The Company believes it has sufficient cash to cover its current needs and planned development programs into October 2025 and is exploring several options to further extend its cash horizon. Revenues in Q1 2025 1 MaaT Pharma reported revenues of EUR 1.1 million for the first quarter of 2025 compared with EUR 0.8 million for the same period of 2024 representing a constant growth, quarter to quarter, year to year. Upcoming financial communications* June 20, 2025: Annual General Meeting September 16, 2025: Publication of H1 2025 results November 4, 2025: Publication of revenues & cash for Q3 2025 *Indicative calendar that may be subject to change. Upcoming investor and business conferences participation June 12-15 – European Hematology Association (EHA) Congress, Milan June 16-19, 2025 – Bio International Convention, Boston, MA June 18-19, 2025 – Portzamparc Conference Mid & Small Caps 2025, Paris September 25, 2025 – KBC Healthcare Conference, Brussels --- About MaaT Pharma MaaT Pharma is a leading, late-stage clinical company focused on developing innovative gut microbiome-driven therapies to modulate the immune system and enhance cancer patient survival. Supported by a talented team committed to making a difference for patients worldwide, the Company was founded in 2014 and is based in Lyon, France. As a pioneer, MaaT Pharma is leading the way in bringing the first microbiome-driven immunomodulator in oncology. Using its proprietary pooling and co-cultivation technologies, MaaT Pharma develops high diversity, standardized drug candidates, aiming at extending life of cancer patients. MaaT Pharma has been listed on Euronext Paris (ticker: MAAT) since 2021. 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 financial results
Yahoo
27-03-2025
- Business
- Yahoo
MaaT Pharma Completes a Capital Increase of €13 Million with Historical Shareholders and Announces 2024 Annual Results
Positive results from Phase 3 trial for MaaT013 in acute Graft-versus-Host disease (aGvHD); topline results (January 2025) showed a 62% gastrointestinal overall response rate at Day 28 and 1-year expected Overall Survival of 54%, demonstrating high efficacy and significant improvement over currently available therapies; Positive final DSMB review confirming remarkable efficacy results and a positive benefit/risk profile. Marketing Authorization Application (MAA) in Europe for MaaT013 on track for EMA submission in June 2025. Initiation of Expanded Access for MaaT013 in aGvHD in the U.S. EAP Revenues of €3.2 million in 2024, a 44% increase over 2023, and the highest revenues generated from the EAP to date. As of December 31, 2024, cash and cash equivalents were €20.2 million. Capital Increase of €13 million supported by historical shareholders to advance towards its next significant operational and financing milestones, extending its cash runway into October 2025. LYON, France, March 27, 2025--(BUSINESS WIRE)--Regulatory News: MaaT Pharma (EURONEXT: MAAT – the "Company"), a clinical-stage biotechnology company and a leader in the development of Microbiome Ecosystem Therapies™ (MET) dedicated to enhancing survival for patients with cancer through immune modulation, today reported the 2024 full-year annual results and announces the completion of a private placement of €13 million at market price through the issuance of 2,131,148 new ordinary shares of the Company at a price per New Share (as defined below) of €6.10, to the benefit of its existing shareholders, Biocodex, PSIM Fund represented by Bpifrance Investissement and a US/EU existing investor. The funds will support the Company's progress towards key value milestones, including market submission for EU approval of MaaT013 in aGvHD, its US expansion strategy, and the conclusion of a potential partnership for its hemato-oncology products in Europe. "I am proud of our team for the significant progresses MaaT Pharma made to date, marked by unprecedented results from our positive Phase 3 trial with our lead asset, MaaT013, supporting our transformational role in hemato-oncology. I'm deeply thankful to our historical shareholders for their renewed support, which will enable the Company to reach major value milestones in the coming months. Looking ahead, we look forward to bringing our innovation to patients in need and creating lasting value for all stakeholders," stated Hervé Affagard, CEO and co-founder of MaaT Pharma. Pipeline highlights In Hemato-Oncology In 2024, MaaT Pharma confirmed its leadership position with microbiome-based therapies for hemato-oncology applications, releasing breakthrough Phase 3 results from its ARES aGvHD trial. The Company is now preparing for the submission of its Market Authorization Approval dossier for its lead-asset MaaT013, while also actively discussing potential partnership options for commercialization in Europe. Acute Graft-versus-Host Disease (aGvHD) – MaaT013 In April 2024, the Company presented for the first time positive 18-month data for MaaT013 showing a clear Overall Survival advantage in aGvHD from the Early Access Program (EAP) at the 2024 EBMT Annual Meeting. Promising data included a gastrointestinal overall response rate (GI-ORR) of 52% at D28 and an Overall Survival (OS) of 47% at 12 months. In September 2024, MaaT Pharma announced that MaaT013 batches were ready for distribution for clinical supply in the US and Europe and that MaaT Pharma advanced the readiness phase for the initiation of clinical activities. In October 2024, MaaT Pharma announced the completion of patient recruitment for ARES, its European Phase 3 clinical trial evaluating the efficacy and safety of MaaT013 in the treatment of steroid refractory and ruxolitinib refractory or intolerant aGvHD (NCT04769895). In December 2024, the Company announced the initiation of the Single Patient Expanded Access in the U.S with the treatment of the first U.S. patient with aGvhD with MaaT013 at City of Hope Hospital, one of the largest and most advanced cancer research and treatment organizations in the United States. In December 2024, MaaT Pharma presented updated data, with a GI-ORR at Day 28 of 51% and an OS rate of 47% at 12 months, for 154 patients with acute Graft-versus-Host Disease (aGvHD) treated with MaaT013 in EAP in Europe during the 66th American Society of Hematology (ASH) Annual Meeting. In January 2025, the Company announces positive topline results from the pivotal Phase 3 ARES Study evaluating MaaT013 in aGvHD. The study met its primary endpoint with a significant gastrointestinal overall response rate at Day 28 of 62% and demonstrates the unprecedented efficacy of MaaT013 as third-line treatment of aGvHD with gastrointestinal involvement (GI-aGvHD) consistent with previously communicated EAP results. The Company anticipates MAA submission in Europe in June 2025. More recently, the Company received positive feedback, further solidifying its plans to submit the MAA dossier with the EMA in June 2025: In March 2025, the Company received positive opinion from EMA Pediatric Committee on the Pediatric Investigation Plan for MaaT013, a key milestone achieved towards a marketing authorization submission to the EMA, expected in June 2025. And also in March 2025, the Company received a positive outcome from the final DSMB meeting on ARES, confirming the remarkable efficacy results and positive risk/benefit profile of MaaT013 in third-line aGvHD. Allogenic Hematopoietic Stem Cell Transplant (allo-HSCT) - MaaT033 In July 2024, the Company announced that the DSMB completed its first safety assessment of the Phase 2b trial PHOEBUS (NCT05762211), aiming at assessing MaaT033 impact in improving overall survival in patients receiving hematopoietic stem cell transplantation, and recommended continuation of the trial without modification. The trial is a European, multi-center, randomized, double-blind study, testing MaaT033, an oral freeze-dried formulation against placebo, set to be conducted in up to 56 clinical investigation sites and expected to enroll 387 patients. In January 2025, the Company announced that the DSMB completed its second safety assessment of the Phase 2b trial PHOEBUS and recommended continuation of the trial without modification. In Immuno-Oncology In 2024, MaaT Pharma advanced its donor-derived MET-N drug candidates in immunotherapy combinations for solid tumors in proof-of-concept clinical phases, while developing its next-generation MET-C drugs using the Company's co-cultured platform, in view of addressing large immuno-oncology indications. MaaT013 and MaaT033 – Proof-of-Concept trials with donor derived drugs (MET-N platform) In March 2024, the Company completed patient recruitment for the Phase 2a randomized clinical trial (NCT04988841) (PICASSO) sponsored by AP-HP and in collaboration with INRAE and Institut Gustave Roussy, evaluating MaaT013 in combination with immune checkpoint inhibitors (ICI), ipilimumab (Yervoy®) and nivolumab (Opdivo®), in metastatic melanoma patients. The Company provided its MaaT013 drug candidate and placebo and will contribute to the microbiome profiling of patients using its proprietary gutPrint® AI research engine, while the trial investigator sponsor handled recruitment, treatment and is overseeing data collection and analysis. Following an updated timeline from the academic sponsor, data readout is now expected in H2 2025, compared to Q1 2025 as previously announced. In May 2024, the Company announced its participation in the IMMUNOLIFE RHU 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. MaaT033 will be tested as a concomitant treatment to cemiplimab (Regeneron), an anti-PD1 therapy, to assess the potential increase in response rate in patients having received randomized multicenter Phase 2 clinical trial will include advanced non-small cell lung cancer (NSCLC) patients. In this investigator-sponsored trial, MaaT Pharma's financial commitment will be limited to clinical product supply. The trial is expected by the sponsor to start mid-2025. MaaT034 - Next-generation drug candidates with co-cultured technology (MET-C platform) In 2024, MaaT Pharma presented new in vitro data on MaaT034's metabolite production and immune modulation at the American Association for Cancer Research (AACR) Annual Meeting (April) and at the Society for Immunotherapy of Cancer (SITC) Annual Meeting (November). MaaT034, the first product from the MET-C platform, is a synthetic microbiota therapy aimed at enhancing immunotherapy responses in solid tumor patients, which represents a potentially large market. Given the current Company's prioritization of resources on its hemato-oncology programs, and particularly on MaaT013's registration activities in Europe, the pace of MaaT034 development activities will be contingent upon further financial resources. In neurodegenerative diseases Outside the Company's main focus in oncology, MaaT Pharma's donor-derived MaaT033 was successfully investigated in ALS, further demonstrating the versatility of the Company's drug platform in other therapeutic domains. The Study met its primary endpoint and positive Phase 1b results were announced in November 2024, confirming its safety and tolerability beyond oncology indications. Corporate update In 2024, MaaT Pharma significantly strengthened its leadership team to support its next development phase, enhancing expertise across key areas to drive its clinical, regulatory, and financial strategy forward. Jonathan Chriqui joined as Chief Business Officer in March, followed by Gianfranco Pittari as Chief Medical Officer and Carole Ifi as Head of Regulatory Affairs in the Summer 2024. In November, Eric Soyer was appointed Chief Financial Officer. These strategic appointments further strengthen execution capabilities of its clinical and development plans. Financial highlights The key financial audited results for the full year of 2024 are as follows. Condensed Income Statement In thousands of euros 31 December 2024 (12 months) 31 December 2023 (12 months) Revenue 3 216 2 228 Other Income 3 831 4 667 Sales, General and Administrative costs (7 781) (5 839) Research and Development costs (27 694) (20 999) Operating income (expense) (28 428) (19 943) Financial Income 401 639 Financial Expense (878) (413) Net financial income (expense) (477) 226 Net Income (loss) for the period (28 904) (19 717) In accordance with IFRS international standards. Detailed financial information available here (French only) The audit procedures for the 2024 financial statements were carried out by the Company's statutory auditor and the 2024 statutory accounts were closed by the Company's Board of Directors on March 24, 2025. The financial statements are available on the Company's website. The full financial reports will be included in the Company's Universal Registration Report (equivalent to the annual financial report), which will be filed with the Autorité des Marchés Financiers on 11 April 2025. Revenues totaled €3.2 million for the year ended December 31, 2024, the highest revenues generated thus far by the Company, mostly comprised of compensation invoiced from the Early Access Program in France and for which data was presented at the American Society of Hematology Annual Meeting in December 2024. Other income of €3.8 million included R&D tax credits of €3.5 million, stable from €3.6 million in the prior year, while grants decreased to €0.1 million in 2024 from €1.0 million in the prior year. Sales, General and Administrative expenses amounted to €7.8 million in 2024, compared with €6.0 million in 2023, reflecting mostly the expenses to support the early access program, as well as the increase in regulatory advisory costs and the strengthening of the team. Research and Development expenses were €27.7 million in 2024, an increase of €6.7 million from 2023, consistent with the advancement of clinical and operational activities as detailed in the pipeline highlights' section above. As a result, Operating expenses amounted to €28.4 million in 2024 compared with €19.9 million for 2023, an increase of €8.5 million. Net loss was to €28.9 million for the year ended December 31, 2024, compared with €19.7 million for the year ended December 31, 2023. Cash Position as of December 31, 2024 As of December 31, 2024, total cash and cash equivalents were €20.2 million, as compared to €27.0 million as of September 30, 2024, and €24.3 million as of December 31, 2023. The net decrease in cash position of €4.1 million between December 31, 2023, and December 31, 2024, was related to a net cash utilization in Operating and Investing activities of €22.0 million and €0.4 million, respectively, while cash generated in financial activities was €18.3 million, including the €17.2 million net proceeds from the May 2024 capital raise. Capital Increase with the support of historical shareholders In this exceptionally challenging financial and economical context, the Company has just carried out a Capital Increase with its historical shareholders, thus giving priorities to secure upcoming key milestones while limiting the dilution and preserving value for all shareholders. Based on its projected plans and its associated financing needs to date, and following the Capital Increase, the Company expects its cash and cash equivalents balance to be sufficient to fund its operations into October 2025. In order to finance its activities for the next twelve months, the Company will need to raise additional funds. The Company is actively discussing additional dilutive and non-dilutive financing options for 2025, which, together with a potential strategic partnership, if materialized, will further finance and accelerate its developments activities, allowing to extend the Company's cash runway. The Capital Increase will enable the Company to pursue its developments plan and confirm its potential for being a key player in hemato-oncology. Upcoming significant value-creation milestones include: the Company is targeting to submit its Market Authorization Application for MaaT013 in aGvHD with the European agency in June 2025, with a potential approval expected in H2 2026; the Company is also preparing for a commercial launch in Europe, based on compelling Phase 3 data released in January 2025; the Company is also actively assessing potential partnership options for the distribution of its hemato-oncology products in Europe, in view of strengthening the launch and market penetration strategy of MaaT013, if approved; in the US, the Company is preparing for the launch of a dedicated US Phase 3 trial in aGvHD, or, subject to FDA's approval, the submission of a US Biologics License Application (BLA) (subject to confirmatory trial) based on compelling European Early Access and Phase 3 data, in view of a late 2026 commercial launch, if approved; the Company will continue the ongoing allo-HSCT Phase 2b study "PHOEBUS" (1yr-OS read out expected in late 2027). Main characteristics of the Capital Increase MaaT Pharma's Board of Directors using the delegation of powers granted by the 25th resolution of the shareholders' general meeting held on May 28, 2024 (capital increase without preferential subscription rights reserved to specific categories of investors) (the "AGM") and in accordance with article L. 225-138 of the French Commercial Code (code de commerce), has authorized the principle of a Capital Increase on March 24, 2025 and the CEO has decided, pursuant to the sub-delegation of authority granted by the Board, to complete a capital increase of 13,000,002.80 euros, by way of issuance of 2,131,148 new shares with a nominal value of €0.10 each (the "New Shares") for a subscription price of €6.10 each (including premium) (the "Capital Increase"). The New Shares will be issued at a market price, corresponding to the closing price of the Company's shares on the Euronext Paris regulated market at the time of the last trading session preceding its setting (i.e. March 26, 2025). The participation of existing shareholders represents the aggregate gross amount of the Capital Increase, namely, Biocodex for 6 million euros, PSIM Fund for 5 million euros, and a US/EU existing investor for 2 million euros. PSIM Fund represented by Bpifrance Investissement and Biocodex are also represented on the Board of Directors of the Company, and as such, did not take part in the vote of the Capital Increase at the Board of Directors' meeting held on March 24, 2025. The New Shares will be of the same class and fully fungible with the existing shares of the Company and will be admitted to trading on the regulated market of Euronext in Paris under the ISIN FR0012634822 - MAAT. The settlement-delivery of the Capital Increase is expected to take place around March 31, 2025, subject to customary conditions. Impact of the Capital Increase on the share capital Following the completion of the Capital Increase, MaaT Pharma's share capital will amount to €1,611,525.10 divided into 16,115,251 shares and the issuance of the New Shares represents 13.2% of the share capital of the Company after the Capital Increase. On an illustrative basis, a shareholder holding 1% of the Company's share capital before the Capital Increase and who did not participate in the Capital Increase will hold 0.87% of the Company's share capital after the issuance of the New Shares. To the Company's knowledge, the shareholding structure, on a non-diluted base, before and after the Capital Increase, breaks down as follows: Shareholders Before Capital Increase (non-diluted basis) After Capital Increase (non-diluted basis) Number of Ordinary Shares held Percentage of Existing Share Capital Number of Ordinary Shares held Percentage of Existing Share Capital Karim Dabbagh 1,960 0.01% 1,960 0.01% Hervé Affagard 266,173 1.90% 266,173 1.65% Total of individual corporate officers 268,133 1.92% 268,133 1.66% Seventure Funds 2,586,379 18.50% 2,586,379 16.05% Crédit Mutuel Innovation SAS 1,412,364 10.10% 1,412,364 8.76% Biocodex SAS 1,859,185 13.29% 2,842,792 17.64% Symbiosis LLC 1,946,735 13.92% 1,946,735 12.08% FPCI Fonds PSIM 2,802,439 20.04% 3,622,111 22.48% US/EU existing investor 623,632 4.46% 951,501 5.90% Other Shareholders 196,128 1.40% 196,128 1.22% Total Historical shareholders 11,426,862 81.71% 13,558,010 84.13% Employees and consultants 183,573 1.31% 183,573 1.14% Public Float 2,105,535 15.06% 2,105,535 13.07% Total 13,984,103 100% 16 115 251 100% Absence of Prospectus In connection with the Capital Increase, no listing prospectus will be approved by the Autorité des Marchés Financiers (the "AMF"). This press release does not constitute a prospectus under Regulation (EU) 2017/1129 of the European Parliament and of the Council of June 14, 2017, as amended (the "Prospectus Regulation"), or a public offering. The Company will file with the AMF a document containing the information set out in Annex IX of the Prospectus Regulation (the "Information Document"), which will be made available on the Company's website ( Risk factors Investors' attention is drawn to the risk factors set out in the 2023 Universal Registration Document filed with the AMF on April 2nd, 2024, under number D.24-0225 as well as in the 2024 half-year financial report, which are available on the Company's website ( and the website of the AMF ( as updated by the risk factors presented in section 4 of the Information Document. The occurrence of any or all of these risks could have an adverse effect on the Company's business, financial situation, results, development or prospects. Financial calendar* May 13, 2025: Publication of revenues & cash for Q1 2025 June 20, 2025: Annual General Meeting September 16, 2025: Publication of H1 results November 4, 2025: Publication of revenues & cash for Q3 2025 *Indicative calendar that may be subject to change. Upcoming conferences participation April 2-3, 2025 – Kempen Life Sciences Conference, Amsterdam April 25 - 30, 2025 – American Association for Cancer Research (AACR) Annual Meeting 2025, Chicago, IL May 5-6, 2025 - Swiss Biotech Day, Basel May 13, 2025 – Forum Midcaps Gilbert Dupont, Paris June 12-15 - European Hematology Association (EHA) Congress, Milan, IT June 16-19, 2025 - Bio International Convention, Boston, MA June 18-19, 2025 – Portzamparc Conference Mid & Small Caps 2025, Paris September 25, 2025 – KBC Healthcare Conference, Brussels About MaaT Pharma MaaT Pharma is a leading, late-stage clinical company focused on developing innovative gut microbiome-driven therapies to modulate the immune system and enhance cancer patient survival. Supported by a talented team committed to making a difference for patients worldwide, the Company was founded in 2014 and is based in Lyon, France. As a pioneer, MaaT Pharma is leading the way in bringing the first microbiome-driven immunomodulator in oncology. Using its proprietary pooling and co-cultivation technologies, MaaT Pharma develops high diversity, standardized drug candidates, aiming at extending life of cancer patients. MaaT Pharma has been listed on Euronext Paris (ticker: MAAT) since 2021. 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. Disclaimer This press release is an advertisement and not a prospectus within the meaning of Regulation (EU) 2017/1129 of the European Parliament and of the Council of 14 June 2017 (as amended, the "Prospectus Regulation"). In France, the offering described above took place solely as a placement to a category of institutional investors, in accordance with Article L. 225-138 of the "Code de commerce" and applicable regulations. The Capital Increase does not constitute a public offering in France, as defined in Article L. 411-1 of the "Code monétaire et financier" and no prospectus reviewed or approved by the Autorité des marchés financiers will be published. With respect to Member States of the European Economic Area (including France), no action has been taken or will be taken to permit a public offering of the securities referred to in this press release which would require the publication of a prospectus in any Member State. This press release and the information it contains is not an offer to sell, nor the solicitation of an offer to subscribe for or buy, New Shares in the United States or any other jurisdiction where restrictions may apply. Securities may not be offered or sold in the United States absent registration under the Securities Act or an exemption from registration thereunder. MaaT Pharma does not intend to register the New Shares under the Securities Act or conduct a public offering of the New Shares in France, the United States, or in any other jurisdiction. This communication is being distributed only to, and is directed only at (a) persons outside the United Kingdom, (b) persons who have professional experience in matters relating to investments falling within Article 19(5) of the Financial Services and Markets Act 2000 (Financial Promotion) Order 2005 (the "Order"), and (c) high net worth entities, and other persons to whom it may otherwise lawfully be communicated, falling within Article 49(2) of the Order (all such persons together being referred to as "relevant persons"). Any investment or investment activity to which this communication relates is available only to relevant persons and will be engaged in only with relevant persons. Any person who is not a relevant person should not act or rely on this communication or any of its contents. This distribution of this press release may be subject to legal or regulatory restrictions in certain jurisdictions. Any person who comes into possession of this press release must inform him or herself of and comply with any such restrictions. View source version on Contacts MaaT Pharma – Investor RelationsGuilhaume DEBROAS, of Investor Relations+33 6 16 48 92 50invest@ Rx Communications Group – U.S. Investor Relations Michael MillerManaging Director+1-917-633-6086mmiller@ MaaT Pharma – Media RelationsPauline RICHAUDSenior PR & Corporate Communications Manager+33 6 14 06 45 92media@ Catalytic Agency – U.S. Media Relations Heather SheaMedia relations for MaaT Pharma +1 617-286-2013 Sign in to access your portfolio
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11-03-2025
- Business
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MaaT Pharma Receives Positive Opinion from EMA Pediatric Committee on the Pediatric Investigation Plan for MaaT013
Positive EMA Pediatric Committee opinion has cleared the investigation clinical plan to evaluate the safety and efficacy of MaaT013 in patients from 6 years old to less than 18 years old with aGvHD Key regulatory milestone showing alignment with EMA expectations for pediatric investigation confirming MaaT013 is on track towards a marketing authorization submission to the EMA in June 2025 MaaT013 has the potential to be the first microbiome-driven therapy approved in Europe LYON, France, March 11, 2025--(BUSINESS WIRE)--Regulatory News: MaaT Pharma (EURONEXT: MAAT – the "Company"), a clinical-stage biotechnology company and a leader in the development of Microbiome Ecosystem TherapiesTM (MET) dedicated to enhancing survival for patients with cancer through immune modulation, announced today that the European Medicines Agency (EMA) Pediatric Committee (PDCO) has approved the Pediatric Investigation Plan (PIP) for MaaT013 for the treatment of acute Graft-versus-Host Disease (aGvHD). "We are very pleased with the productive dialogue with the EMA Pediatric Committee and the positive PIP opinion. This approval marks a major regulatory milestone towards the submission of our Marketing Authorization dossier with the EMA," said Gianfranco Pittari, MD, PhD, Chief Medical Officer at MaaT Pharma. "Through our Early Access Program, we have already successfully and safely treated two pediatric patients with aGvHD. We are committed to bringing MaaT013 to pediatric patients suffering from aGvHD, who currently have limited options." The EMA PDCO approved the clinical program to evaluate the safety and efficacy of MaaT013 in patients from 6 years old to less than 18 years old, with the initiation, in 2026, of a single-arm trial in third-line treatment for 18 patients with aGvHD and in line with the Company's cash projections. Based on this positive opinion, MaaT013 would be eligible for up to an additional two years of marketing exclusivity in Europe, on top of the ten-year European market exclusivity as an orphan drug if the Marketing Authorization is granted by the EMA. This also confirms the Company's ability to reach the full patient population. "With this approval of our Pediatric Investigation Plan, we are now on track to submit our Marketing Authorization dossier in June this year. If approved, the Company could be positioned to generate revenues as soon as late 2026 with MaaT013 in third-line treatment in aGvHD," stated Hervé Affagard co-founder and CEO of MaaT Pharma, "Additionally, the Company will continue to provide the product through its Early Access Program for all patients in need." --- About the Pediatric Committee (PDCO)The Pediatric Committee (PDCO) is the European Medicines Agency's (EMA) scientific committee responsible for activities on medicines for children and to support the development of such medicines in the European Union by providing scientific expertise and defining pediatric needs. The PDCO issues an opinion on PIP as part of the regulatory process and the EMA adopts a final decision based on the PDCO's opinion. About the Pediatric Investigation Plan (PIP)A pediatric investigation plan (PIP) is a development plan aimed at ensuring that the necessary data are obtained through studies in children, to support the authorization of a medicine for children. As part of the regulatory process for the registration of new medicines in Europe, the EMA requires pharmaceutical companies to provide a PIP detailing their strategy for investigation of the new medicinal product in the pediatric population. An approved PIP is a prerequisite for filing a Marketing Authorization Application (MAA). About acute Graft-versus-Host DiseaseAcute Graft-versus-Host Disease occurs in patients within 100 days of undergoing a stem cell or bone marrow transplant, where the transplanted cells initiate an immune response and attack the transplant recipient's organs, causing inflammation of the skin, liver and/or gastro-intestinal tract and leading to significant morbidity and mortality. GI involvement is associated with severe complications such as profound diarrhea, abdominal pain, intestinal bleeding, and death. These complications are often life-threatening, with increased mortality risk, due to the challenges of managing severe GI inflammation and the associated risks of infection, malnutrition, and organ failure. The standard first line therapy for treating aGvHD is the use of systemic steroids. If patients do not respond to steroids, they are considered Steroid Resistant (SR) and other agents can be administered. Currently, the second-line treatment for steroid-refractory acute graft-versus-host disease (SR aGvHD) is ruxolitinib. Recently, remestemcel—L-rknd was approved in December 2024 in the US specifically for use in the paediatric population as a second-line treatment. About MaaT013MaaT Pharma's Microbiome Ecosystem TherapiesTM (MET) are designed to leverage a full microbiome ecosystem to restore balance and maximize clinical benefits for patients with severe, treatment-induced dysbiosis in acute diseases. MaaT013 is a full-ecosystem, off-the-shelf, standardized, pooled-donor, enema Microbiome Ecosystem TherapyTM for acute, hospital use. It is characterized by a consistently high diversity and richness of microbial species and the presence of ButycoreTM (a group of bacterial species known to produce anti-inflammatory metabolites). MaaT013 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 thus reduce steroid-resistant, gastrointestinal (GI)-aGvHD. MaaT013 has been granted Orphan Drug Designation by the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA). About MaaT PharmaMaaT Pharma is a leading, late-stage clinical company focused on developing innovative gut microbiome-driven therapies to modulate the immune system and enhance cancer patient survival. Supported by a talented team committed to making a difference for patients worldwide, the Company was founded in 2014 and is based in Lyon, France. As a pioneer, MaaT Pharma is leading the way in bringing the first microbiome-driven immunomodulator in oncology. Using its proprietary pooling and co-cultivation technologies, MaaT Pharma develops high diversity, standardized drug candidates, aiming at extending life of cancer patients. MaaT Pharma has been listed on Euronext Paris (ticker: MAAT) since 2021. Forward-looking StatementsAll 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. View source version on Contacts MaaT Pharma – Investor Relations Guilhaume DEBROAS, of Investor Relations+33 6 16 48 92 50invest@ Rx Communications Group – U.S. Investor Relations Michael MillerManaging Director+1-917-633-6086mmiller@ MaaT Pharma – Media Relations Pauline RICHAUDSenior PR & Corporate Communications Manager+33 6 14 06 45 92media@ Catalytic Agency – U.S. Media Relations Heather SheaMedia relations for MaaT Pharma+1 Sign in to access your portfolio
