{"id":53247,"date":"2023-01-24T18:02:59","date_gmt":"2023-01-24T17:02:59","guid":{"rendered":"https:\/\/pharma-trend.com\/en\/maat-pharma-provides-corporate-update-and-highlights-key-expected-milestones-in-2023\/"},"modified":"2023-01-24T18:02:59","modified_gmt":"2023-01-24T17:02:59","slug":"maat-pharma-provides-corporate-update-and-highlights-key-expected-milestones-in-2023","status":"publish","type":"post","link":"https:\/\/pharma-trend.com\/en\/maat-pharma-provides-corporate-update-and-highlights-key-expected-milestones-in-2023\/","title":{"rendered":"MaaT Pharma Provides Corporate Update and Highlights Key Expected Milestones in 2023"},"content":{"rendered":"<div>\n<p>LYON, France&#8211;(BUSINESS WIRE)&#8211;<a href=\"https:\/\/twitter.com\/search?q=%24MAAT&amp;src=ctag\" target=\"_blank\" rel=\"noopener\">$MAAT<\/a>&#8211;Regulatory News:\n<\/p>\n<p><a href=\"https:\/\/mms.businesswire.com\/media\/20230124005830\/en\/729326\/5\/Nov_2018_new_version_MaaT_Pharma_logo.jpg\"><img decoding=\"async\" src=\"https:\/\/mms.businesswire.com\/media\/20230124005830\/en\/729326\/21\/Nov_2018_new_version_MaaT_Pharma_logo.jpg\"><\/a><\/p>\n<p>\n<b><a target=\"_blank\" href=\"https:\/\/cts.businesswire.com\/ct\/CT?id=smartlink&amp;url=https%3A%2F%2Fwww.maatpharma.com%2F&amp;esheet=53289909&amp;newsitemid=20230124005830&amp;lan=en-US&amp;anchor=MaaT+Pharma&amp;index=1&amp;md5=917abf828e5c36dd080f0c07f9f5a0f9\" rel=\"nofollow noopener\" shape=\"rect\">MaaT Pharma<\/a><\/b> <b>(EURONEXT: MAAT \u2013 the \u201cCompany\u201d), a French clinical-stage biotech and a pioneer in the development of Microbiome Ecosystem Therapies<sup>TM<\/sup> (MET) dedicated to improving survival outcomes for patients with cancer, <\/b>provides a corporate update highlighting the progress, adjustments to clinical programs and key development milestones expected in 2023.\n<\/p>\n<p>\n<i>\u201cMaaT Pharma has delivered important clinical milestones during 2022 including the expansion of its development pipeline with the launch of two clinical trials for its lead drug candidate, MaaT013 in hemato-oncology (Phase 3) and in immuno-oncology (Phase 2a). The year 2022 also marks an important milestone for the global microbiome industry with the regulatory approvals of the first microbiome-based drugs by the FDA in the U.S. and by the TGA in Australia,\u201d <\/i><b>stated<\/b> <b>Herv\u00e9 Affagard, CEO and co-founder of MaaT Pharma.<\/b> <i>\u201cDespite difficult market conditions, we continue to advance our pioneering science and technology and we remain focused on delivering new therapeutic solutions to the benefit of patients with severe conditions as well as building value for our shareholders. 2023 will be a year with important inflection points and will require us to act decisively to reach our objectives. We thank our investors for their support throughout this year, and their confidence in our ability to achieve the next level of corporate development.\u201d<\/i>\n<\/p>\n<p>\n<b>Clinical development<\/b>\n<\/p>\n<p>\n<b>Hemato-oncology<\/b>\n<\/p>\n<p>\nMaaT013, a full-ecosystem, standardized, pooled-donor native Microbiome Ecosystem Therapy for acute, hospital use (enema administration)\n<\/p>\n<p>\n<b>MaaT013 for the treatment of acute Graft-versus-Host Disease (aGvHD)<\/b>: MaaT013 has received an Orphan Drug Designation by both the U.S. Food and Drug Administration (FDA) and the European Medical Agency (EMA).\n<\/p>\n<ul class=\"bwlistdisc\">\n<li>\nMaaT013 is currently being evaluated in Europe in an <a target=\"_blank\" href=\"https:\/\/cts.businesswire.com\/ct\/CT?id=smartlink&amp;url=https%3A%2F%2Fwww.maatpharma.com%2Fmaat-pharma-announces-first-patient-dosed-in-phase-3-ares-trial-evaluating-maat013-in-patients-with-acute-graft-vs-host-disease%2F&amp;esheet=53289909&amp;newsitemid=20230124005830&amp;lan=en-US&amp;anchor=ongoing+international+multicenter+open-label%2C+single+arm%2C+pivotal+Phase+3+trial&amp;index=2&amp;md5=2315b1c3f56ff974ee8844b244c67235\" rel=\"nofollow noopener\" shape=\"rect\">ongoing international multicenter open-label, single arm, pivotal Phase 3 trial<\/a> (ARES) in 75 patients with steroid-resistant gastrointestinal aGvHD. The Company has received full regulatory approvals in the following countries, which is more than initially envisioned: Austria, Belgium, France, Germany, Italy, and Spain. A safety and efficacy data review will be conducted by an independent data safety and monitoring board (DSMB) after enrollment of half of the patients in the study. The review is expected in the first half of 2023 and the Company will communicate the DSMB\u2019s recommendations following the review.\n<\/li>\n<li>\nThe initiation of clinical trials following the Investigational New Drug (IND) application for MaaT013 in the United States (U.S.) will depend on the outcome of ongoing exchanges with the FDA in response to the <a target=\"_blank\" href=\"https:\/\/cts.businesswire.com\/ct\/CT?id=smartlink&amp;url=https%3A%2F%2Fwww.maatpharma.com%2Faugust-10-2022-maat-pharma-announces-update-on-u-s-fda-investigational-new-drug-application-for-maat013-in-patients-with-acute-graft-versus-host-disease%2F&amp;esheet=53289909&amp;newsitemid=20230124005830&amp;lan=en-US&amp;anchor=August+2022+continued+clinical+hold+letter&amp;index=3&amp;md5=380ab86484c7a521603554b8c204a883\" rel=\"nofollow noopener\" shape=\"rect\">August 2022 continued clinical hold letter<\/a>. The most recent communication received by the Company from the FDA stated that the complete response provided by the Company in response to the letter received in August 2022, was still under review. Feedback could be expected in the early part of 2023 and the Company will update investors accordingly. The Company understands that the FDA\u2019s Center for Biologics Evaluation and Research (CBER) that currently hosts all microbiome-based drug candidates, continues to prioritize their work to advance the nation\u2019s response to the COVID-19 public health emergency, which is creating additional delays. Despite this, the Company remains focused on achieving regulatory approval for MaaT013 in the U.S. and providing a therapeutic solution for patients in the country.\n<\/li>\n<li>\nMaaT013 has already been successfully evaluated in a Phase 2 clinical trial<b> <\/b>in patients with steroid-resistant grade III-IV gastro-intestinal (GI) aGvHD (HERACLES) as well as in an ongoing compassionate use program (EAP) in France in patients with Grade II-IV GI-aGvHD having failed previous therapies,<b> <\/b><a target=\"_blank\" href=\"https:\/\/cts.businesswire.com\/ct\/CT?id=smartlink&amp;url=https%3A%2F%2Fwww.maatpharma.com%2Fdecember-10-2022-maat-pharma-presents-compelling-consolidated-maat013-clinical-data-at-the-64th-ash-annual-meeting%2F&amp;esheet=53289909&amp;newsitemid=20230124005830&amp;lan=en-US&amp;anchor=with+promising+results+presented+at+the&amp;index=4&amp;md5=7a64f3e7d488a2a131369196eb881da1\" rel=\"nofollow noopener\" shape=\"rect\">with promising results presented at the <\/a><a target=\"_blank\" href=\"https:\/\/cts.businesswire.com\/ct\/CT?id=smartlink&amp;url=https%3A%2F%2Fwww.maatpharma.com%2Fdecember-10-2022-maat-pharma-presents-compelling-consolidated-maat013-clinical-data-at-the-64th-ash-annual-meeting%2F&amp;esheet=53289909&amp;newsitemid=20230124005830&amp;lan=en-US&amp;anchor=2022+American+Society+of+Hematology+%28ASH%29+conference+in+an+oral+presentation&amp;index=5&amp;md5=988db97bc2aee74c68a58797a2977a36\" rel=\"nofollow noopener\" shape=\"rect\">2022 American Society of Hematology (ASH) conference in an oral presentation<\/a><a target=\"_blank\" href=\"https:\/\/cts.businesswire.com\/ct\/CT?id=smartlink&amp;url=https%3A%2F%2Fwww.maatpharma.com%2Fdecember-10-2022-maat-pharma-presents-compelling-consolidated-maat013-clinical-data-at-the-64th-ash-annual-meeting%2F&amp;esheet=53289909&amp;newsitemid=20230124005830&amp;lan=en-US&amp;anchor=and+in+a+poster+at+the+2022+edition+of+the+International+Human+Microbiome+Consortium+%28IHMC%29.&amp;index=6&amp;md5=d72fbf1deecc454545c75c39b9b35392\" rel=\"nofollow noopener\" shape=\"rect\"> and in a poster at the 2022 edition of the International Human Microbiome Consortium (IHMC).<\/a> The compelling data demonstrates that the pooled microbiota product is well tolerated and shows a good safety profile in a fragile patient population. Efficacy of MaaT013 correlates with engraftment of the product\u2019s microbial species in the gut and clinical response to MaaT013 translates to increased overall survival in patients with aGvHD.\n<\/li>\n<\/ul>\n<p>\nMaaT033, a donor-derived, standardized, high-richness, high-diversity Microbiome Ecosystem Therapy for oral administration, currently being developed as an adjunctive and maintenance therapy to improve overall survival in patients receiving HSCT<sup>1<\/sup>.\n<\/p>\n<p>\n<b>MaaT033 for the improved survival of patients with hematological malignancies receiving allo-HSCT<\/b>\n<\/p>\n<ul class=\"bwlistdisc\">\n<li>\nBased on <a target=\"_blank\" href=\"https:\/\/cts.businesswire.com\/ct\/CT?id=smartlink&amp;url=https%3A%2F%2Fwww.maatpharma.com%2Fdecember-11-2022-maat-pharma-presents-promising-detailed-results-from-completed-phase-1b-trial-with-maat033-at-the-64th-ash-annual-meeting%2F&amp;esheet=53289909&amp;newsitemid=20230124005830&amp;lan=en-US&amp;anchor=promising+results+following+the+Phase+1b+trial+presented+at+the+2022+edition+of+the+ASH+annual+meeting&amp;index=7&amp;md5=671e8a13f246eb6a3ed17ef2bf78835b\" rel=\"nofollow noopener\" shape=\"rect\">promising results following the Phase 1b trial presented at the 2022 edition of the ASH annual meeting<\/a>, and learnings from this study, along with an in-depth review of the Protocol Assistance with the EMA, and discussions with potential partners showing an interest in the license and commercialization of MaaT033 in this therapeutic area, the Company has optimized and adjusted the protocol for the Phase 2b trial of MaaT033 (PHOEBUS). In this context and given the strategic importance of the trial, the Company has decided to take over the sponsorship of the clinical trial in Europe. At the time of the IPO, it was anticipated that AP-HP<sup>2<\/sup> would sponsor the trial in France as an Investigator-sponsored trial. The study is expected to start in Q2 2023 and would now be conducted in Europe in accordance with EMA recommendations. The number of patients enrolled in the study would expand from 341 to 387 and the number of sites would be increased from 20 to 56, enabling the recruitment period to be reduced from 36 to 24 months.\n<\/li>\n<\/ul>\n<ul class=\"bwlistdisc\">\n<li>\nWhile the primary endpoint of the study is to evaluate the efficacy of MaaT033 in improving overall survival at 12 months, secondary endpoints would include the evaluation of safety and tolerability before and after allo-HSCT, and the evaluation of the engraftment of beneficial microbial species from MaaT033 and the activity in preventing allo-HSCT complications (infections, GvHD).\n<\/li>\n<li>\nAdditional readouts have been included throughout the 24-month recruitment period, such as interim safety analysis with stopping rules<sup>3<\/sup> when the trial has enrolled and randomized, respectively, 60 and 120 patients.\n<\/li>\n<li>\nThe expected timelines including the overall survival endpoint (data to be expected in H1 2026) announced by MaaT Pharma during the IPO should be confirmed based on the adjustments mentioned above.\n<\/li>\n<li>\nIn parallel to starting the trial in Europe, the Company plans to discuss this program with the FDA upon conclusion of ongoing dialogues with the Agency regarding its pooling technology.\n<\/li>\n<\/ul>\n<p>\n<b>Immuno-oncology \u2013 Clinical and nonclinical programs<\/b>\n<\/p>\n<p>\n<b>MaaT013 for the improvement of patients\u2019 response to Immune Checkpoint Inhibitors (ICI) \u2013proof of concept Phase 2a clinical trial sponsored by AP-HP<\/b>\n<\/p>\n<ul class=\"bwlistdisc\">\n<li>\nThe proof-of-concept double blind randomized Phase 2a clinical trial, PICASSO (n=60), <a target=\"_blank\" href=\"https:\/\/cts.businesswire.com\/ct\/CT?id=smartlink&amp;url=https%3A%2F%2Fwww.maatpharma.com%2Fmaat-pharma-announces-the-initiation-of-a-phase-2a-investigator-sponsored-clinical-trial-evaluating-maat013-in-combination-with-immune-checkpoint-inhibitors-for-patients-with-melanoma%2F&amp;esheet=53289909&amp;newsitemid=20230124005830&amp;lan=en-US&amp;anchor=initiated+in+April+2022%2C&amp;index=8&amp;md5=9bf701cee1c72168b3a4279922b2a08f\" rel=\"nofollow noopener\" shape=\"rect\">initiated in April 2022,<\/a> evaluating MaaT013\u2019s impact on the efficacy of ICI treatments (ipilimumab + nivolumab) in patients with metastatic melanoma, remains on track as planned.\n<\/li>\n<li>\nThis trial is an Investigator-sponsored trial by AP-HP, where MaaT Pharma supplies drug candidates and performs the microbiome profiling of patients using its proprietary gutPrint\u00ae platform.\n<\/li>\n<li>\nKey study endpoints after 23 weeks of treatment include MaaT013\u2019s safety profile and best-overall response rate <i>vs<\/i> placebo as an add-on treatment to ipilimumab + nivolumab.\n<\/li>\n<li>\nThe Company is expected to receive biological biomarker data in H1 2023 after half of the patients have been enrolled and achieved their evaluation 9 weeks after randomization.\n<\/li>\n<li>\nResults are expected in H2 2024, as planned.\n<\/li>\n<\/ul>\n<p>\n<b>MaaT03x, a new generation high richness, co-cultured, designed Microbiome Ecosystem Therapy<sup>TM<\/sup> in oral formulation for the increase in the response rate to ICI in patients with solid tumors &#8211; currently in preclinical testing.<\/b>\n<\/p>\n<ul class=\"bwlistdisc\">\n<li>\nAs MaaT03x is expected to be used in large markets, MaaT Pharma has been focused on increasing the level of readiness and decided to enter a Phase 1b trial in Europe and the U.S. in the first half of 2024, as opposed to the second half of 2023 as initially announced. This is a result of changes and adjustments following announcements of first regulatory approvals for microbiome-based products and the Company\u2019s work for the development of its native products (MaaT013 &amp; MaaT033) in Europe. MaaT Pharma is consolidating <i>in vivo\/in vitro<\/i> data, continuing product development characterization and conducting regulatory readiness of MaaT03x. Preclinical data are expected to be shared at scientific conferences in 2023.\n<\/li>\n<\/ul>\n<ul class=\"bwlistdisc\">\n<li>\nMaaT Pharma has initiated early interactions with the EMA in 2022 including a meeting with the <a target=\"_blank\" href=\"https:\/\/cts.businesswire.com\/ct\/CT?id=smartlink&amp;url=https%3A%2F%2Fwww.ema.europa.eu%2Fen%2Fhuman-regulatory%2Fresearch-development%2Finnovation-medicines%23ema%27s-innovation-task-force-%2528itf%2529-section&amp;esheet=53289909&amp;newsitemid=20230124005830&amp;lan=en-US&amp;anchor=EMA%27s+Innovation+Task+Force+%28ITF%29.&amp;index=9&amp;md5=d478c9921042c30c3b05edb33b91c0ba\" rel=\"nofollow noopener\" shape=\"rect\">EMA&#8217;s Innovation Task Force (ITF).<\/a> Further interactions in Europe are expected to take place in 2023. The Company is also planning early interactions with the FDA in H1 2023 to present its MaaT03x platform and has already filed a meeting request.\n<\/li>\n<li>\nThe Company will be able to strengthen its intellectual property (IP) portfolio in France and internationally thanks to the co-cultured new generation products. Currently, the Company holds the IP for 14 patent families.\n<\/li>\n<\/ul>\n<p>\n<b>Therapeutic pipeline extension<\/b>\n<\/p>\n<p>\nRecent studies have highlighted the importance of the microbiota-gut-brain axis and the impact of the gut microbiome in brain diseases. Interestingly, patients with neurodegenerative disorders display both central nervous system (CNS) and gastrointestinal symptoms<sup>4<\/sup>. In parallel, scientific research has started to shed light on the role of the gut microbiome, linking abnormalities to diseases such as Amyotrophic lateral sclerosis (ALS<sup>5<\/sup>). The link between gut microbiota and ALS first emerged from preclinical evidence and then from clinical observations indicating a disease-modifying role for the gut microbiome. To date, there is no effective treatment for ALS, a disease that leads to death within an average of 3-5 years after diagnosis<sup>6<\/sup>. ALS affects nerve cells in the brain and the spinal cord causing loss of muscle control. Since its inception, MaaT Pharma has been committed to restoring a microbial symbiosis in life-threatening diseases with high unmet clinical needs. Growing evidence suggests that ALS patients show increased inflammation in the gut with changes in the composition of gut microbes and low levels of beneficial bacteria.\n<\/p>\n<p>\nMaaT Pharma has decided to extend its scientific research to the management of ALS, which could pave the way for the treatment of several neurodegenerative diseases. The Company is leveraging the strong safety profile of its native MET products (MaaT033\/MaaT013) and their inherent product characteristics of promoting immune modulation\/anti-inflammatory properties and acting as a homeostasis hub. The number of ALS cases is expected to increase substantially in the developing world over the next 25 years and could reach a total of 60,000 patients in U.S. and Europe by 2040<sup>7<\/sup>. Every year, 5,000 new patients are diagnosed in the U.S. and in Europe and the incidence of ALS ranges from 3 to 4 per 100,000 person-years7.\n<\/p>\n<p>\nLeveraging 12 months of feasibility assessment in MaaT Pharma\u2019s Discovery team, the Company expects to initiate in H1 2023 a Phase 1b pilot study in ALS evaluating MaaT033 to slow down disease progression. The study, developed with experts from the ALS network (FILSLAN and ACT4ALS-MND) and strongly supported by the French patient association <i>(Tous en Selles contre la SLA)<\/i>, will enroll up to 15 patients presenting initial motor deficit i.e., at least 6 months up to 24 months at the time of the screening<i>.<\/i> This pipeline expansion to a new indication demonstrates the strong potential of MaaT033 to be used in an acute or chronic setting as a standalone, adjunctive and maintenance therapy. Data readout from the pilot study is expected for the first half of 2024.\n<\/p>\n<p>\nIf this initial trial is successful, the Company could extend further to other chronic diseases\/ immuno-inflammatory diseases as MaaT Pharma collects data and strengthens in-depth understanding of the mechanism of action. Funding for the trial is already secured and the program has been designed to minimize the risk and not impact the Company\u2019s lead programs in oncology. The key study endpoints are assessment of safety and tolerability of multiple doses of MaaT033, the assessment of gut microbiota composition evolution and the identification of biomarkers sensitive to treatment before considering a larger randomized controlled efficacy study.\n<\/p>\n<p>\n<b>cGMP manufacturing facilities<\/b>\n<\/p>\n<p>\nMaaT Pharma is <a target=\"_blank\" href=\"https:\/\/cts.businesswire.com\/ct\/CT?id=smartlink&amp;url=https%3A%2F%2Fwww.maatpharma.com%2Fmaat-pharma-and-skyepharma-have-entered-a-partnership-to-establish-the-first-exclusive-microbiome-ecosystem-therapies-cgmp-manufacturing-facility-in-france%2F&amp;esheet=53289909&amp;newsitemid=20230124005830&amp;lan=en-US&amp;anchor=currently+building+its+future+manufacturing+facilities%2C+in+partnership+with+Skyepharma.&amp;index=10&amp;md5=33548262f5b21e44f700598726fa96ed\" rel=\"nofollow noopener\" shape=\"rect\">currently building its future manufacturing facilities, in partnership with Skyepharma.<\/a> The 1600m<sup>2<\/sup> facility will be able to support the needs of clinical and commercial production of its native MET (MaaT013 &amp; MaaT033), R&amp;D and clinical batches of cultured products, MaaT03x, up to 2034.\n<\/p>\n<p>\nFunding is secured and the completion of the facility is expected in mid-2023. Under the terms of the partnership agreement, MaaT Pharma will retain the know-how of its bio-manufacturing processes and agility (full command end-to-end manufacturing processes), while leveraging Skyepharma\u2019s experience in running a cGMP facility. Having this facility is a strong competitive advantage for a late-stage company preparing for commercial phase, which MaaT Pharma believes will facilitate potential commercial partnerships. The site will be the first in France, and the largest specialized manufacturing facility for full ecosystem microbiome therapies in Europe to date. The facility will also increase potential synergies within the microbiome industry and contribute to structuring the production of microbiome-based drugs. It will provide a fully integrated manufacturing and development platform that will allow quick and efficient product development, scale-up and GMP processes.\n<\/p>\n<p>\n<b>Financing plans &amp; update on cash runway<\/b>\n<\/p>\n<p>\nFollowing an in-depth review of its ongoing programs, in particular the deferral of the clinical study of MaaT03x from 2023 to 2024 and savings on discretionary spending, the Company has optimized and prioritized its operations, extending its cash runway to end of Q4 2023, as compared to end of Q3 2023 as previously announced. The Company is also evaluating options that will finance operations and bring its late-stage products close to commercial launch. The focus is on both dilutive and non-dilutive financing, including business deals. The Company is confident in the continuing and longstanding support of its historical investors.\n<\/p>\n<p>\nThe Company has updated its corporate presentation, which can be download here: <a target=\"_blank\" href=\"https:\/\/cts.businesswire.com\/ct\/CT?id=smartlink&amp;url=https%3A%2F%2Fwww.maatpharma.com%2Finvestors%2F&amp;esheet=53289909&amp;newsitemid=20230124005830&amp;lan=en-US&amp;anchor=https%3A%2F%2Fwww.maatpharma.com%2Finvestors%2F&amp;index=11&amp;md5=4caf538460128d0dd219329d92018ce3\" rel=\"nofollow noopener\" shape=\"rect\">https:\/\/www.maatpharma.com\/investors\/<\/a>\n<\/p>\n<p>\n<b>About MaaT Pharma<\/b>\n<\/p>\n<p>\nMaaT 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\u00ae, supports the development and expansion of its pipeline by determining novel disease targets, evaluating drug candidates, and identifying biomarkers for microbiome-related conditions.\n<\/p>\n<p>\nThe company\u2019s 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.\n<\/p>\n<p>\nMaaT Pharma is listed on Euronext Paris (ticker: MAAT).\n<\/p>\n<p>\n<b>Forward-looking Statements<\/b>\n<\/p>\n<p>\nAll 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\u2019s control. These statements may include, without limitation, any statements preceded by, followed by or including words such as \u201ctarget,\u201d \u201cbelieve,\u201d \u201cexpect,\u201d \u201caim,\u201d \u201cintend,\u201d \u201cmay,\u201d \u201canticipate,\u201d \u201cestimate,\u201d \u201cplan,\u201d \u201cproject,\u201d \u201cwill,\u201d \u201ccan have,\u201d \u201clikely,\u201d \u201cshould,\u201d \u201cwould,\u201d \u201ccould\u201d 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\u2019s control that could cause the Company\u2019s actual results or performance to be materially different from the expected results or performance expressed or implied by such forward-looking statements.\n<\/p>\n<p>\n<i><b><sup>1<\/sup><\/b><\/i><i> HSCT= Hematopoietic stem-cell transplantation<br \/>\n<br \/><\/i><i><b><sup>2<\/sup><\/b><\/i><i> AP-HP = Assistance Publique &#8211; H\u00f4pitaux de Paris<br \/>\n<br \/><\/i><i><b><sup>3<\/sup><\/b><\/i><i> A stopping rule is a set of safety criteria primarily used to determine when the study needs to be paused or halted.<br \/>\n<br \/><\/i><i><b><sup>4<\/sup><\/b><\/i><i> <\/i><i>Gebrayel et al, J Transl Med, 2022<\/i><i>, Singh et al, J Clin Invest. 2021<br \/>\n<br \/><\/i><i><b><sup>5<\/sup><\/b><\/i><i> Rowin et al., 2017; Nicholson et al, 2021; Blacher et al, 2019, Mazzini et al, 2020<br \/>\n<br \/><\/i><i><b><sup>6<\/sup><\/b><\/i><i> <a target=\"_blank\" href=\"https:\/\/cts.businesswire.com\/ct\/CT?id=smartlink&amp;url=https%3A%2F%2Ftousensellescontrelasla.fr%2Fla-sla-cest-quoi%2F&amp;esheet=53289909&amp;newsitemid=20230124005830&amp;lan=en-US&amp;anchor=https%3A%2F%2Ftousensellescontrelasla.fr%2Fla-sla-cest-quoi%2F&amp;index=12&amp;md5=3aa74f0b7bca35276efe2b973e504e67\" rel=\"nofollow noopener\" shape=\"rect\">https:\/\/tousensellescontrelasla.fr\/la-sla-cest-quoi\/<\/a><br \/><\/i><i><b><sup>7<\/sup><\/b><\/i><i> Longinetti.et.al 2019, <\/i><i>Arthur, K., Calvo, A., Price, T. et al., US Centers for disease control and prevention &#8211; <\/i><i>National ALS Registry 2016<\/i>\n<\/p>\n<p> <b>Contacts<\/b> <\/p>\n<p>\n<b>MaaT Pharma \u2013 Investor Relations<\/b><br \/>Herv\u00e9 AFFAGARD<br \/>\n<br \/>Co-Founder and CEO<br \/>\n<br \/>Si\u00e2n CROUZET, COO\/ CFO<br \/>\n<br \/>+33 4 28 29 14 00<br \/>\n<br \/><a target=\"_blank\" href=\"&#x6d;&#97;&#105;&#x6c;&#x74;&#111;&#58;&#x69;&#x6e;&#118;&#101;&#x73;&#x74;&#64;&#109;&#x61;&#x61;&#116;&#45;&#x70;&#x68;&#97;&#114;&#x6d;&#x61;&#46;&#99;&#x6f;&#x6d;\" rel=\"nofollow noopener\" shape=\"rect\">&#x69;&#110;v&#x65;&#x73;&#116;&#64;&#x6d;&#x61;&#97;t&#x2d;&#x70;&#104;a&#x72;&#x6d;&#97;&#46;&#x63;&#111;&#109;<\/a>\n<\/p>\n<p>\n<b>MaaT Pharma \u2013 Media Relations<\/b><br \/>Pauline RICHAUD<br \/>\n<br \/>Senior PR &amp; Corporate Communications Manager<br \/>\n<br \/>+33 6 14 06 45 92<br \/>\n<br \/><a target=\"_blank\" href=\"&#x6d;&#x61;&#105;l&#x74;&#x6f;&#x3a;&#109;e&#x64;&#x69;&#x61;&#64;m&#x61;&#x61;&#x74;&#45;p&#x68;&#x61;&#x72;&#109;a&#x2e;&#x63;&#x6f;&#109;\" rel=\"nofollow noopener\" shape=\"rect\">&#x6d;&#x65;&#x64;&#x69;&#x61;&#x40;&#x6d;&#x61;&#x61;&#x74;&#x2d;&#x70;&#x68;&#x61;&#x72;&#x6d;&#x61;&#x2e;&#x63;&#x6f;&#x6d;<\/a>\n<\/p>\n<p>\n<b>Trophic Communications \u2013 Corporate and Medical Communications<\/b><br \/>Gretchen SCHWEITZER or Charlotte SPITZ<br \/>\n<br \/>+49 171 351 27 33<br \/>\n<br \/><a target=\"_blank\" href=\"&#109;&#x61;&#105;&#x6c;&#116;&#x6f;&#58;&#x6d;&#97;&#x61;&#116;&#x40;&#116;&#x72;&#111;&#x70;&#104;&#x69;&#99;&#x2e;&#101;&#x75;\" rel=\"nofollow noopener\" shape=\"rect\">&#x6d;&#x61;&#97;&#116;&#64;&#x74;&#x72;&#x6f;&#112;&#104;i&#x63;&#x2e;&#x65;&#117;<\/a>\n<\/p>\n<\/div>\n","protected":false},"excerpt":{"rendered":"<p>LYON, France&#8211;(BUSINESS WIRE)&#8211;$MAAT&#8211;Regulatory News: MaaT Pharma (EURONEXT: MAAT \u2013 the \u201cCompany\u201d), 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, provides a corporate update highlighting the progress, adjustments to clinical programs and key development milestones expected in 2023. \u201cMaaT Pharma &#8230; <span class=\"more\"><a class=\"more-link\" href=\"https:\/\/pharma-trend.com\/en\/maat-pharma-provides-corporate-update-and-highlights-key-expected-milestones-in-2023\/\">[Read more&#8230;]<\/a><\/span><\/p>\n","protected":false},"author":4,"featured_media":0,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[13],"tags":[],"class_list":{"0":"entry","1":"post","2":"publish","3":"author-business","4":"post-53247","6":"format-standard","7":"category-industry"},"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v27.5 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>MaaT Pharma Provides Corporate Update and Highlights Key Expected Milestones in 2023 - Pharma Trend<\/title>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/pharma-trend.com\/en\/maat-pharma-provides-corporate-update-and-highlights-key-expected-milestones-in-2023\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"MaaT Pharma Provides Corporate Update and Highlights Key Expected Milestones in 2023 - Pharma Trend\" \/>\n<meta property=\"og:description\" content=\"LYON, France&#8211;(BUSINESS WIRE)&#8211;$MAAT&#8211;Regulatory News: MaaT Pharma (EURONEXT: MAAT \u2013 the \u201cCompany\u201d), 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, provides a corporate update highlighting the progress, adjustments to clinical programs and key development milestones expected in 2023. \u201cMaaT Pharma ... 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