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AUSTIN, Texas and TOKYO, Sept. 19, 2025 /PRNewswire/ -- According to DataM Intelligence, the global liver cancer therapeutics market size was valued at US$3.36 billion in 2024 and is expected to reach US$13.16 billion by 2033, growing at a CAGR of 16.5% during the forecast period 2025-2033. The liver cancer therapeutics market is entering a transformative phase, driven by the shift from traditional systemic therapies to innovative immunotherapies and targeted agents that offer improved survival outcomes. The growing adoption of combination regimens, particularly checkpoint inhibitors paired with VEGF or TKI therapies, is expected to redefine the treatment landscape and expand the eligible patient pool. At the same time, the rising prevalence of hepatocellular carcinoma worldwide, coupled with strong R&D pipelines and increasing regulatory approvals, positions this market for sustained growth. A significant advancement in liver cancer therapeutics is the approval of combination immunotherapy regimens. Notably, AstraZeneca's Imfinzi (durvalumab) plus Imjudo (tremelimumab) gained global recognition after the HIMALAYA trial demonstrated a meaningful overall survival benefit in patients with unresectable hepatocellular carcinoma. This approval provided a new first-line treatment option beyond tyrosine kinase inhibitors and VEGF-targeted therapies, offering durable survival outcomes for a subset of patients and reshaping the standard of care in advanced HCC. Another key advancement is the expansion of targeted oral therapies, which have improved safety and efficacy profiles. Drugs such as lenvatinib and cabozantinib have demonstrated substantial clinical activity as first- or second-line options, while ongoing research is investigating their use in combination with checkpoint inhibitors. The growing pipeline of next-generation TKIs and precision therapies, tailored to genetic and molecular profiles, is driving innovation, improving patient survival, and reinforcing the importance of oral targeted agents in the long-term management of HCC. Get a Sample PDF Brochure of the Report (Use Corporate Email ID for a Quick Response): The chemotherapy segment, based on therapy type, is expected to account for 39.1% of the liver cancer therapeutics market share. Chemotherapy remains a vital part of the liver cancer therapeutics market, especially for patients with intermediate-stage hepatocellular carcinoma (HCC) or those ineligible for surgical resection or transplantation. Trans-arterial chemoembolization (TACE) is a standard of care used in clinical settings and often combined with targeted therapies. Despite the rise of immunotherapies and precision drugs, chemotherapy remains vital due to its established protocols, lower costs, and widespread availability. Clinical studies are exploring the synergy of chemotherapeutic agents with immunomodulators to prolong survival and delay disease progression. The North American liver cancer therapeutics market was valued at 42.1% market share in 2024. North America is expected to dominate the liver cancer therapeutics market due to its robust healthcare infrastructure, high awareness, and significant investments in oncology research and development (R&D). For instance, in January 2025, researchers at Mount Sinai made a significant breakthrough in treating hepatocellular carcinoma (HCC), a type of liver cancer. Additionally, the rise in liver cancer incidence, driven by NAFLD, obesity, and chronic hepatitis C, has increased early diagnosis rates and demand for advanced therapeutics. The FDA's favorable regulatory pathways, including priority reviews and orphan drug designations, have accelerated drug approval, ensuring rapid market access. The liver cancer therapeutics market in the U.S. dominated the North America market with the largest revenue share in 2024, driven by the increasing investment in pharmaceuticals. The regulatory framework in the U.S. ensures only safe and effective drugs reach the market, which increases trust of patients and healthcare providers in the medicines. Furthermore, the involvement of major players and the launch of novel treatments contribute to its dominance. Regulatory approvals for innovative drugs support market expansion, making the U.S. a leader in liver cancer treatments. This environment fosters continuous innovation and growth. Get Customization in the Report as Per Your Business Requirements: Europe is the second-dominating region in the liver cancer therapeutics market, valued at 34.5% market share in 2024. The liver cancer therapeutics market in Europe is driven by the growing prevalence of hepatitis B and C infections, rising alcohol consumption, and increasing cases of non-alcoholic fatty liver disease (NAFLD). Supportive regulatory approvals for novel immunotherapies, combined with a well-established healthcare infrastructure and government-backed cancer screening programs, are driving the adoption of advanced treatment regimens. In the U.K., a high burden of liver disease linked to obesity, diabetes, and alcohol misuse is accelerating demand for effective HCC treatments. National Health Service (NHS) initiatives to expand early cancer diagnosis, along with faster access schemes for innovative oncology drugs, further drive uptake of immunotherapies and targeted therapies. The Asia-Pacific region in the Liver Cancer Therapeutics Market was valued at 23.5% market share in 2024. This region is witnessing significant growth due to the very high incidence of hepatitis B and C, particularly in China and Southeast Asia, which are leading causes of HCC. Rising investments in healthcare infrastructure, increased clinical trial activity, and expanding patient access to immuno-oncology drugs are driving market growth. In Japan, liver cancer remains a leading cause of cancer mortality, primarily associated with hepatitis virus infections and an ageing population. Strong government support for oncology research, rapid adoption of cutting-edge immunotherapies, and the presence of domestic pharmaceutical players are key factors driving therapeutic innovation and market expansion. For instance, in June 2025, Ono Pharmaceutical Co., Ltd. and Bristol-Myers Squibb K.K. received supplemental approval for their anti-PD-1 antibody, Opdivo, and BMSKK's anti-CTLA-4 antibody, Yervoy, in combination therapy in Japan to expand their use for treating unresectable hepatocellular carcinoma (HCC), a type of cancer. Purchase This Exclusive Report at Just USD 4350 Only: Key Liver Cancer Therapeutics Companies: Top companies in the liver cancer therapeutics market include AstraZeneca, Bayer AG, Eli Lilly, Bristol-Myers Squibb Company, Eisai Co., Ltd., Genentech and among others. Recent Developments in the Market In September 2025, Akeso, Inc. has dosed the first patient in its Phase II registrational trial, evaluating cadonilimab, Akeso's first-in-class PD-1/CTLA-4 bispecific antibody, in combination with lenvatinib for treating advanced hepatocellular carcinoma in patients previously treated with atezolizumab and bevacizumab. In July 2025, Apollo Proton Cancer Centre (APCC) has launched an 'Advanced Liver Cancers Clinic', an integrated clinic for primary liver cancers and liver metastases. Related Reports: Pediatric Oncology Drugs Market Size, Share, Industry, Forecast and Outlook (2024-2031) Cancer Immunotherapy Market Size, Trends & Forecast 2033 Hepatocellular Carcinoma Treatment Market Size, Share, Growth Trends and Forecast Report 2025-2033 About DataM Intelligence 4Market Research: DataM Intelligence 4Market Research is a comprehensive market intelligence platform offering syndicated and customized reports along with expert consulting across multiple industries, including chemicals, healthcare, agriculture, food & beverages, and more. With extensive experience and a strategy-focused approach, DataM provides businesses and individuals with reliable market insights, statistical forecasts, and personalized research solutions to help them make informed decisions and successfully bring innovations to market. To find out more, visit or follow us on Twitter, LinkedIn and Facebook. Contact: Mr. Sai Kiran DataM Intelligence 4market Research LLP Ground floor DSL Abacus IT Park, Industrial Development Area Uppal, Hyderabad, Telangana 500039 USA: +1 877-441-4866 Email: [email protected] Content Source: Visit Our Website: Logo: SOURCE DataM Intelligence 4 Market Research LLP WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

Positive results from Phase 3 trial for MaaT013 in acute Graft-versus-Host disease (aGvHD); topline results showed a 62% gastrointestinal overall response rate at Day 28 and 1-year expected Overall Survival of 54%, demonstrating high efficacy and significant clinical improvement over currently available therapies. Marketing Authorization application of Xervyteg ® (MaaT013) in aGvHD submitted to the European Medicines Agency (EMA) in June 2025. Signature of a license and commercial agreement with Clinigen to facilitate patient access across Europe. €10.5 million upfront payment received and €18 million additional payments depending on the achievement of pre-specified regulatory and sales milestones. The Company will also be eligible to receive royalty payments on both EAP treatments and net commercial sales of a percentage in the mid-thirties and regular cash flow as per the supply agreement of Xervyteg ® . Signature of a €37.5 million, 4-tranche financing from the European Investment Bank (EIB). The financing will support the advancement of its late-stage hemato-oncology clinical programs including the lead-asset Xervyteg ® for the treatment of aGvHD and the second drug candidate, MaaT033, currently being evaluated in a Phase 2b randomized controlled trial in improving survival for patients receiving allo-HSCT. As of June 30, 2025, cash and cash equivalents were €15 million, excluding the initial Clinigen payment and the EIB financing. Including the €10.5 million Clinigen payment and the upcoming €3.5 million EIB tranche A, the cash runway is extended until end of February 2026. Revenues of €2.4 million in H1 2025, compared to €1.7 million in H1 2024, +41%, linked to a continuous increase in demand for Xervyteg ® in the Early Access Program, in all regions. LYON, France--(BUSINESS WIRE)--Regulatory News: "As we move into the second half of 2025, we remain focused on execution, preparing with Clinigen for potential market entry, and strengthening our leadership in microbiome-based therapies,” stated Eric Soyer, Chief Financial Officer of MaaT Pharma. 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 its half year financial results for the six-month period ended June 30, 2025, and provided a business overview. “In the first half of the year, MaaT Pharma achieved key clinical and regulatory milestones, bringing us closer to providing a much-needed therapeutic option for patients with aGvHD and to becoming the first Company to bring a microbiome medicine to market in Europe. With the EMA submission of Xervyteg® (MaaT013), our Clinigen partnership, and the EIB financing, we have strengthened both our operations and financial position. These achievements illustrate our strategy to advance development while preserving shareholder value through a balanced mix of dilutive and non-dilutive funding. As we move into the second half of 2025, we remain focused on execution, preparing with Clinigen for potential market entry, and strengthening our leadership in microbiome-based therapies,” stated Eric Soyer, Chief Financial Officer of MaaT Pharma. Pipeline Highlights In Hemato-Oncology Acute Graft-versus-Host Disease (aGvHD) – Xervyteg® (MaaT013) In January 2025 , the Company announced positive topline results from the pivotal Phase 3 ARES Study evaluating Xervyteg ® (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 Xervyteg ® as third-line treatment of aGvHD with gastrointestinal involvement (GI-aGvHD) consistent with communicated EAP results. In March 2025 , the Company received positive opinion from European Medicines Agency (EMA).Pediatric Committee on the Pediatric Investigation Plan for Xervyteg ® (MaaT013), a key milestone achieved towards the Marketing Authorization Application (MAA) submission to the EMA. In March 2025 , the Company announced 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 GI-aGvHD. In June 2025 , the Company announced the submission of a Marketing Authorization Application (MAA) to the 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, the first one in hemato-oncology worldwide and the first approved therapy in third-line GI-aGvHD. In June 2025 , the Company presented positive updated data in Early Access Program for 173 patients at the 2025 annual EHA Congress supporting the high efficacy and good safety profile of Xervyteg ® . This dataset confirms the breakthrough potential of Xervyteg ® for aGvHD patients with limited treatment options. In July 2025 , the Company announced the signature of a license and commercial agreement with Clinigen , a global specialty pharmaceutical services group and a leading European player in hospital distribution and market access, to streamline the pathway for ensuring access to this medicine across Europe. With this partnership, MaaT Pharma demonstrates its capability to supply products to pharmaceutical companies, including those specializing in rare diseases while ensuring scale-ups for commercial. The Company received an upfront payment of €10.5 million and could receive additional payments of up to €18 million depending on the achievement of pre-specified regulatory and sales milestones. The Company will also be eligible to receive royalty payments on net sales of a percentage in the mid-thirties and regular cash flow as per the supply agreement. Final results from the pivotal ARES study, including 12-month overall survival data, are expected before the end of 2025 and will be incorporated into the filing dossier. Data are also being submitted in a peer reviewed journal and upcoming scientific congress. The potential marketing authorization could be delivered around mid-2026 (if approved), then enabling the start of the commercialization of Xervyteg ® in Europe in the second half of 2026. In parallel, the Company continues discussions with the FDA for a dedicated pivotal study in the U.S., with the objective of enabling the earliest possible access to Xervyteg ® for U.S. patients. Such a study could be initiated in 2026, subject to regulatory confirmation as MaaT Pharma continues watching the evolving regulatory policies and process in the United States, and subject to appropriate financing. The Company continues to expand its U.S. footprint through its Early Access Program, with recurring patient requests now coming from three leading hospitals: City of Hope (Duarte- Los Angeles, CA), Massachusetts General Hospital (Boston, MA), and the University of Alabama Hospital (Birmingham, AL). Allogenic Hematopoietic Stem Cell Transplant (allo-HSCT) - MaaT033 Over the past 12 months, four DSMB safety assessments were conducted for MaaT033 in the Phase 2b PHOEBUS randomized trial designed to be pivotal: three routine evaluations and one interim analysis focused on excess mortality. All confirmed a favorable safety profile and recommended continuation of the trial without modifications. The last patient enrollment in the trial is anticipated for mid-2026, with 1-year Overall Survival results expected in H2 2027. In Immuno-Oncology Xervyteg® and MaaT033 – Exploratory trials using the MET-N platform (donor derived conducted as Investigator-Sponsored Trials (ISTs) to inform further developments In March 2024 , the Company completed patient recruitment for the Phase 2a randomized clinical trial (NCT04988841) (PICASSO) sponsored by AP-HP in Paris and in collaboration with INRAE and Institut Gustave Roussy, evaluating Xervyteg ® in combination with immune checkpoint inhibitors (ICI), ipilimumab (Yervoy ® ) and nivolumab (Opdivo ® ), in metastatic melanoma patients. The primary endpoint is to assess whether the safety of Xervyteg ® combined with ipilimumab and nivolumab differs from that of ipilimumab and nivolumab plus placebo. The Company provided its Xervyteg ® 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 is overseeing data collection and analysis. Data readout is expected in H2 2025 as previously announced. In May 2024 , the Company announced its participation in the IMMUNOLIFE ‘RHU’ (university hospital trial) 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 who have received antibiotics. The primary endpoint will be the disease control rate (DCR), defined as the proportion of patients who do not exhibit disease progression (CR, PR, or SD) according to RECIST 1.1 criteria. This investigator-sponsored, randomized, multicenter Phase 2 trial will evaluate MaaT033 in patients with advanced non-small cell lung cancer (NSCLC), with MaaT Pharma supplying the investigational product. The trial is expected by the sponsor to start in H2 2025. MaaT034 – Next-generation drug candidates with co-cultured technology (MET-C platform) to expand in solid tumors In April 2025 , the Company presented new preclinical data for MaaT034, its next generation product, showing compelling anti-tumor efficacy results in germ-free mice at the American Association for Cancer Research (AACR) Annual Meeting 2025. Key results included: Metagenomic analysis shows that MaaT034 reproduces the microbial functions of Xervyteg ® , improves DC-mediated T cell activation and potentiates anti-tumor effects mediated by anti-PD-1 checkpoint blockade in vitro. MaaT034 optimizes anti-PD1 mediated activity in tumor-bearing, germ-free mice. While anti-PD1 alone reduced tumor growth by 10%, the combination of anti-PD1 and MaaT034 resulted in a 83.7% tumor growth reduction (compared to a 24.2% reduction when using a single strain of Akkermansia muciniphila bacteria). 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 updates In March 2025 , the Company announced the completion of a capital increase of €13 million with historical shareholders. In July 2025 , the Company announced that it has secured a €37.5 million, 4-tranche financing from the European Investment Bank (EIB). The financing will support the advancement of its late-stage hemato-oncology clinical programs including the lead-asset Xervyteg ® , recently partnered with Clinigen in Europe, and currently under regulatory review by the European Medicines Agency (EMA) for the treatment of aGvHD and the second drug candidate, MaaT033, currently being evaluated in a Phase 2b randomized controlled trial in improving survival for patients receiving allo-HSCT. Following the annual review of the Euronext Paris indices on September 11, 2025, the Scientific Index Committee has decided to include MaaT Pharma in the CAC Small, CAC Mid & Small, and CAC All-Tradable indices. In addition, during the first part of 2025, the Company’s free float increased from 12.57% to 24.94%. MaaT Pharma announces evolution of its leadership team, with the appointment of: Key Financial Results The key unaudited financial results for the first half of 2025 are as follows: Income Statement In thousands of euros 2025.06 (6 months) 2024.06 (6 months) Revenue 2 427 1 721 Cost of Goods Sold (790) (537) Gross Margin 1 637 1 184 Other Income 2 494 1 935 Sales and distribution costs (491) (308) General and administrative costs (3 611) (2 872) Research and development costs (14 778) (12 695) Operating Income (loss) (14 749) (12 756) Financial Income 87 161 Financial Expense (422) (262) Net financial income (expense) (336) (101) Income (loss) before income tax (15 085) (12 856) Income tax expense - - Net Income (loss) for the period (15 085) (12 856) Prepared in accordance with international accounting standards IFRS Revenues totaled €2.4 million as of June 30, 2025, compared with €1.7 million on June 30, 2024, mostly driven by the 37.5% increase in sales from the Early Access Program at €2.3 million vs €1.7 million in the previous year. Operating loss was €14.7million in the first half of 2025 compared with €12.8 million in the first half of 2024. The €2.0 million increase was mostly attributable to research and development costs, which progressed from €12.7 million in the first half of 2024 to €14.8 million in the first half of 2025, consistent with the advancement of the Company’s late stage clinical programs, in particular with the data analysis and regulatory activities for MaaT013 (Xervyteg®) and with the ongoing patient recruitment in the PHOEBUS Phase 2b trial in allogeneic-HSCT with MaaT033. Cash Position As of June 30, 2025, total cash and cash equivalents were €15.0 million, compared with €20.2 million as of December 31, 2024. The cash position as of June 30, 2025 does not include the upfront payment received from Clinigen’s partnership in July 2025 and the upcoming Tranche A from the EIB expected in September 2025. Over the first half of 2025, net cash utilization was €5.1 million. Net cash used in Operating and Investment activities was €15.4 million, in line with the operating loss for the period, while cash generated in the Financing activities was €10.3 million, with net proceeds from the €13 million capital raise in March 2025, while loan repayments were €1.6 million. With the upfront payment from its commercialization agreement with Clinigen and the already available and upcoming first tranche from the loan agreement with the EIB, and with continued strong cash discipline, the Company believes it has sufficient cash to cover its current needs and planned development programs to the end of February 2026. The Company is pursuing several dilutive and non-dilutive financing options, leveraging on the financing initiatives announced over the summer, to further extend its cash horizon. The Company has updated its corporate presentation available on its website: www.maatpharma.com/investors and has filed its half-year Financial Report to the AMF (Autorité des Marchés Financiers). Upcoming financial communication and conferences* September 23, 2025: Lyon Pole Bourse Forum September 25, 2025: KBC Securities Life Sciences Conference, Brussels October 1, 2025: BNP-Portzamparc Conference October 7-8, 2025: Investor Access Event, Paris November 4, 2025: Publication of revenues and cash position for Q3 2025 *Indicative calendar that may be subject to change. --- 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.