On July 28, 2025 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, reported that it has secured a €37.5 million, 4-tranche financing from the European Investment Bank (EIB) (Press release, MaaT Pharma, JUL 28, 2025, View Source [SID1234654565]). 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 acute Graft-versus-Host Disease (aGvHD) and the second drug candidate, MaaT033, currently being evaluated in a Phase 2b randomized controlled trial in improving survival for patients receiving allogeneic stem cell transplants.

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With robust cGMP manufacturing, proprietary therapies, and a development platform, MaaT Pharma is a global leader in microbiome-based oncology, pioneering full-ecosystem therapies to improve survival in oncology. Since completing enrollment in the ARES trial for Xervyteg (MaaT013) in October 2024, MaaT Pharma has steadily advanced its roadmap, reporting topline results in January 2025, submitting the Marketing Authorization Application with the European Medicines Agency in June 2025, and signing an exclusive agreement for marketing and distribution in Europe with Clinigen in July 2025.

The €37.5 million financing from the EIB follows a rigorous due diligence process by the EIB and further confirms MaaT Pharma’s innovation, strategic vision and operational maturity. This funding is part of a global financial strategy to support the Company’s development that combines various non-dilutive and dilutive sources to best preserve shareholder value.

Eric Soyer, Chief Financial Officer, MaaT Pharma, said: "We are grateful for the confidence shown in MaaT Pharma and the support from the EIB, which is a further foundation towards the next phase of MaaT Pharma’s growth on bringing the potential first microbiome-based therapy to market in Europe. Each operational and financing step strengthens our track record. Following the regulatory submission to the EMA for Xervyteg(MaaT013) and our recent partnership with Clinigen for its commercialization, the EIB financing represents another step in reinforcing the Company’s financial position. As previously announced, MaaT Pharma intends to fund its plans and development programs while preserving shareholder value in the best manner possible with a mix of non-dilutive and dilutive financial sources, and the recent announcements of both partnership financing with the Clinigen agreement and debt financing with the EIB agreement, are benchmarks to reflect that strategy."

Summary of the main terms and conditions of the Loan and Warrants

The loan would be available in four (4) tranches, respectively of €3.5 million for Tranche A, €6.0 million for Tranche B, €8.0 million for Tranche C, and €20.0 million for Tranche D, each tranche with Warrants attached. Disbursement of Tranches 2 to 4 are subject to operational and financing conditions. All Tranches are redeemable after a grace period of 4 years from the date of drawing, with reimbursement over a period of 2 years (Tranche A, B and C, i.e. a maturity of 6 years) to 4 years (Tranche D, i.e. a maturity of 8 years). Each tranche will bear interests at 7%, it being provided that some interests will be deferred and paid at maturity and for Tranche C and Tranche D part of the interest will be paid quarterly.

MaaT Pharma will issue warrants to the benefit of EIB at the time of (and subject to) disbursement of each tranche in a number depending, for each relevant tranche, on the amount of the relevant tranche and the average price per share paid by investors in the context of equity injection made prior to disbursement of the relevant tranche (except for tranche A where the average price per share over the last trading days preceding the date of execution of the financing agreement). Each warrant will give right to subscribe to one share at a price per warrant equal to 99% of the average price over a period of 5 trading days preceding the issuance of each Warrant. The Warrants may be exercised at any time following maturity of Tranche A. The Warrants will have a 20-year term.

EIB and MaaT Pharma have also agreed on (i) a put option to the benefit of EIB under which MaaT Pharma undertook to acquire from EIB all or part of the Warrants upon occurrence of certain events and (ii) a call option to the benefit of MaaT Pharma under which EIB undertook to sell all its Warrants, upon occurrence of a public tender offer over the securities issued by MaaT Pharma.

The Warrants are not transferable, except to affiliates of EIB or except in case of occurrence of certain events (including maturity date of Tranche D). In case of transfer of Warrants to third party, MaaT Pharma shall benefit from a preemptive right to acquire the Warrants first.

MaaT Pharma was assisted in this transaction by Mr. Eric Briole and by Van Lanschot Kempen as Financial Advisors and McDermott Will & Emery as Legal Advisor.

On July 28, 2025 Servier reported that Blood Advances published long-term data from the Phase 3 AGILE trial evaluating TIBSOVO (ivosidenib) in combination with azacitidine versus placebo-azacitidine in patients with newly diagnosed mutant isocitrate dehydrogenase 1 (mIDH1) acute myeloid leukemia (AML) who were unfit to receive intensive chemotherapy (Press release, Servier, JUL 28, 2025, View Source [SID1234654582]). The post-hoc analysis reports positive long-term follow-up results from the pivotal Phase 3 AGILE trial and continues to demonstrate the sustained survival benefit reported in the previous analysis published in the New England Journal of Medicine (NEJM).

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"The clear and robust clinical benefit demonstrated by these long-term analyses – including prolonged overall survival and hematologic recovery – support TIBSOVO as a standard of care treatment for patients with IDH1-mutated AML," said Susan Pandya, M.D., Vice President Clinical Development and Global Head of Oncology LS/LCM, Servier. "These data are a testament to Servier’s industry-leading research in IDH1-mutated cancers, including AML, and demonstrate our steadfast commitment to improving outcomes for patients."

As of data cutoff in June 2022, median follow-up was 28.6 months. Key findings from the newly published analysis include:

Median overall survival (OS) was significantly longer in patients treated with the TIBSOVO combination (29.3 months; 95% CI, 13.2 – not reached) than placebo-azacitidine (7.9 months; 95% CI, 4.1-11.3; hazard ration [HR]=0.42 [0.27, 0.65]; p<.0001).
Hematologic recovery was generally faster and lasted longer in patients in the TIBSOVO arm compared to placebo-azacitidine. Conversion to transfusion independence was more common with TIBSOVO (53.8%) than placebo-azacitidine (17.1%; p=.0004).
Ten (30.3%) of the 33 molecular measurable-residual disease (MRD)-evaluable patients in the TIBSOVO arm converted to an MRD-negative response by Day 1 of Cycle 14, all of whom had a complete response (CR). Seven (70%) of these patients converted to an MRD-negative response by Day 1 of Cycle 7. Of the 23 patients who remained MRD-positive, 19 had a CR and four had a CR with incomplete hematologic recovery (CRi). Two patients (20%) had an MRD-negative response in the placebo-azacitidine arm.
The long-term safety profile of TIBSOVO with azacitidine was consistent with previously reported data. The most commonly reported Grade ≥3 hematologic adverse events (AEs) were anemia (26.4%), neutropenia (30.6%), and febrile neutropenia (27.8%). The most common Grade ≥3 nonhematologic AEs were electrocardiogram QT prolonged (11.1%), pneumonia (22.2%), nausea, (2.8%), hypokalemia (2.8%), and pyrexia (2.8%). There were no new or unexpected safety signals or additional treatment discontinuations due to AEs compared with the primary analysis.
"Long-term results from the AGILE trial underscore the power of TIBSOVO to improve outcomes for patients with IDH1-mutated AML unfit for intensive chemotherapy, a group who historically has had a poor long-term prognosis," said Hartmut Döhner, MD, Professor of Medicine and Director of the Department of Internal Medicine III at the University Hospital Ulm in Germany and Director of the National Center for Tumor Diseases SouthWest (NCT-SW; Ulm site). "These results continue to emphasize the importance of early systematic genetic testing to guide treatment selection for patients – which may lead to improved overall survival rates and a reduction in the risk of death as seen in this study."

TIBSOVO was approved by the U.S. Food and Drug Administration (FDA) in combination with azacitidine for the treatment of patients with newly diagnosed IDH1-mutated AML in adults 75 years or older, or who have comorbidities that preclude use of intensive induction chemotherapy, in May 2022 under Priority Review. The supplemental New Drug Application (sNDA) for TIBSOVO was reviewed by the FDA under its Real-Time Oncology Review (RTOR) pilot program, which aims to ensure that safe and effective treatments are available to patients as early as possible.

On July 27, 2025 Antengene Corporation Limited ("Antengene", SEHK: 6996.HK), a leading innovative, commercial-stage global biopharmaceutical company dedicated to discovering, developing and commercialising first-in-class and/or best-in-class medicines for cancer, reported that an abstract featuring the latest data from a Phase I/II study of the Claudin 18.2 antibody-drug conjugate (ADC), ATG-022, has been accepted for poster presentation at the 2025 European Society for Medical Oncology Annual Congress (ESMO 2025), taking place from October 17th to October 21st at the Messe Berlin in Berlin, Germany (Press release, Antengene, JUL 27, 2025, View Source;302514585.html [SID1234654553]).

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Details of the Poster Presentation:

ATG-022 (Claudin 18.2 antibody-drug conjugate)
Title: Phase I/II study of Claudin 18.2 ADC ATG-022 in patients with advanced gastric/ gastroesophageal junction cancer (CLINCH)
Abstract Number: 2907
Presentation Number: 2113P
Date: October 19, 2025

About ATG-022

ATG-022 is an antibody-drug conjugate (ADC) designed to target CLDN18.2, a member of the Claudin family of cell adhesion molecules. Under normal conditions, Claudins are located within tight junctions between cells, forming a barrier to regulate cell permeability. However, in cancer, Claudins are aberrantly expressed on the cell surface due to changes in cell polarity. CLDN18.2 is frequently overexpressed in a range of primary malignant tumors, including gastric, esophageal, cholangiocarcinoma, and pancreatic cancers. The U.S. Food and Drug Administration (FDA) has awarded Orphan Drug Designations to ATG-022, for gastric and pancreatic cancers.

Data from the ongoing CLINCH study demonstrated that ATG-022 delivers robust efficacy across all levels of CLDN18.2 expression in gastric cancer patients, including those with high, low, and ultra-low expression. This broad activity positions ATG-022 as a potential market leader, capable of addressing the largest patient population with CLDN18.2-positive tumors. Furthermore, the strong efficacy observed in patients with low CLDN18.2 expression suggests promise for treating other tumor types with similar expression profiles.

On July 27, 2025 Hengrui Pharma (600276.SH; 01276.HK) reported it has entered into agreements with GSK plc (LSE/NYSE: GSK) to develop up to 12 innovative medicines, adding significant value to the globalization strategy of Hengrui and significant new growth opportunities to GSK beyond 2031 (Press release, Hengrui Pharmaceuticals, JUL 27, 2025, View Source;inflammation-and-oncology-302514566.html [SID1234654554]). The programmes were selected to complement GSK’s extensive Respiratory, Immunology & Inflammation (RI&I) and Oncology pipeline, and assessed for their potential best- or first-in-class profiles. GSK will pay $500 million in upfront fees across the agreements.

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The agreements include an exclusive worldwide license (excluding mainland China, Hong Kong SAR, Macau SAR and Taiwan region) for a potential best-in-class, PDE3/4 inhibitor (HRS-9821) in clinical development for the treatment of chronic obstructive pulmonary disease (COPD) as an add-on maintenance treatment, irrespective of background therapy. The addition of HRS-9821 supports GSK’s ambition to treat patients across the widest spectrum of COPD by including those who face continued dyspnoea (shortness of breath) or who are unlikely to receive inhaled corticosteroids or biologics, based on their disease profile.

HRS-9821 has demonstrated potent PDE3 and PDE4 inhibition, leading to increased bronchodilation and anti-inflammatory effects in early clinical and preclinical studies. In addition, HRS-9821 provides the opportunity for a convenient dry-powder inhaler (DPI) formulation that strategically fits GSK’s established inhaled portfolio.

The agreements also include a pioneering scaled collaboration to generate up to 11 programmes in addition to HRS-9821, each with its own financial structure. Hengrui Pharma will lead the development of these programmes up to completion of phase I trials, including patients outside of China. GSK will have the exclusive option to further develop and commercialise each programme worldwide (excluding mainland China, Hong Kong SAR, Macau SAR and Taiwan region), at the end of phase I or earlier at GSK’s election as well as certain programme substitution rights.

Frank Jiang, Executive Vice President and Chief Strategy Officer of Hengrui Pharma, said: "This strategic collaboration with GSK marks yet another significant milestone in Hengrui’s globalisation journey and our mission to innovate and deliver higher-quality, cutting-edge therapies for patients worldwide. GSK brings additional R&D expertise, a robust global clinical network, and broad regulatory capabilities that will accelerate our PDE3/4 inhibitor as well as an array of other innovative therapy programs to overseas markets, potentially delivering breakthrough treatments to patients globally."

Tony Wood, Chief Scientific Officer, GSK said: "We’re delighted to announce these exciting agreements with Hengrui Pharma which complement our already-extensive pipeline. This deal reflects our strategic investment in programmes that address validated targets, increasing the likelihood of success, and with the option to advance those assets with the greatest potential for patient impact."

The collaboration enables scale and speed to proof-of-concept to develop up to 11 additional innovative medicines. It benefits from GSK’s therapy area expertise, deep understanding of disease biology, clinical development capability and global commercial scale with Hengrui Pharma’s early discovery engine, platform technologies, extensive pre-clinical pipeline of high-value programmes and speed of clinical evaluation.

Financial considerations
GSK will pay $500 million in upfront fees across the agreements including for the license of the PDE3/4 programme. The potential total value of future success-based development, regulatory and commercial milestone payments to Hengrui Pharma is approximately $12 billion if all programmes are optioned and all milestones are achieved. In addition, Hengrui Pharma will be eligible to receive tiered royalties on global product net sales (excluding mainland China, Hong Kong SAR, Macau SAR and Taiwan region).

The license to HRS-9821 is subject to customary conditions, including applicable regulatory agency clearances under the Hart-Scott-Rodino Act in the US.

On July 27, 2025 Harbour BioMed (the "Company"; HKEX: 02142), a global biopharmaceutical company focused on the discovery and development of novel antibody therapeutics in immunology and oncology, reported a positive profit alert for the six months ended June 30, 2025 (the "Reporting Period") (Press release, Harbour BioMed, JUL 27, 2025, View Source [SID1234654556]).

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Based on a preliminary review of the Company’s unaudited management accounts for the Reporting Period, total profit is expected to range between US$68 million (equivalent to approximately HK$532 million) and US$74 million (equivalent to approximately HK$579 million).

The anticipated increase in profit is primarily attributable to:

Continuing strategic partnerships with leading global pharmaceutical companies, including the global strategic collaboration with AstraZeneca.
– The Company has received gross proceeds totaling approximately US$175 million from the allotment and issuance of the subscription shares, as well as partial upfront, milestone, and option exercise fees.
Newly secured out-licensing and collaboration agreements for innovative products, which contributed significantly to revenue during the Reporting Period and are evolving into a normalized revenue stream of the Company.
Dr. Jingsong Wang, Founder, Chairman and CEO of Harbour BioMed, commented: "This anticipated improvement in profitability underscores the meaningful progress we’ve made in executing our strategic priorities. The performance reflects the strength of our diversified business model and our ability to translate scientific innovation into tangible value. We will continue to build on this momentum through innovation and high-impact collaborations to deliver sustainable growth."