MaaT Pharma Secures €37.5 Million Loan From European Investment Bank (EIB) Marking a New Step in Advancing its Clinical Program in Hemato-Oncology

On July 28, 2025 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, 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 [SID1234654558]). 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.

NMPA Accepts sNDA for Ivonescimab in Combination with Chemotherapy as First-Line Treatment for Advanced Squamous Non-Small Cell Lung Cancer

On July 28, 2025 Akeso, Inc. (9926.HK) ("Akeso" or the "Company") reported that the National Medical Products Administration (NMPA) has accepted the supplementary New Drug Application (sNDA) for ivonescimab (PD-1/VEGF bispecific antibody) in combination with chemotherapy as a first-line treatment for advanced squamous non-small cell lung cancer (sq-NSCLC) (Press release, Akeso Biopharma, JUL 28, 2025, View Source [SID1234654555]).

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This submission represents the third accepted application for ivonescimab in China, following previous filings for its combination therapy in EGFR-TKI resistant locally advanced or metastatic non-squamous NSCLC (nsq-NSCLC), as well as its monotherapy for first-line treatment of PD-L1 positive advanced NSCLC.

PD-1 combined with chemotherapy has become a cornerstone in cancer therapy. The sNDA for ivonescimab’s new indication is based on the strong positive outcomes from its Phase III trial (AK112-306/HARMONi-6 study), which showed that ivonescimab combined with chemotherapy is superior to tislelizumab plus chemotherapy. Building on the success of its head-to-head comparison with pembrolizumab, ivonescimab’s ability to outperform PD-1 combination therapy marks a significant step forward in the evolution of global cancer immunotherapy.

Currently, ivonescimab is involved in over 12 registrational/Phase III clinical trials worldwide, including six head-to-head studies with PD-1/L1 inhibitors. These trials span a diverse range of malignancies, such as various subtypes of lung cancer, first-line colorectal cancer, first-line head and neck squamous cell carcinoma, first-line biliary tract cancer, first-line pancreatic cancer, and first-line triple-negative breast cancer, among others. Ivonescimab has established a broad and strategic footprint across key cancer immunotherapy indications. As part of the company’s "IO+ADC" 2.0 oncology strategy, ivonescimab is positioned as a cornerstone agent in immuno-oncology, being evaluated in combination with innovative therapies targeting novel mechanisms and pathways.

Elpis Biopharmaceuticals Signs Memorandum of Understanding with National Cancer Centre Singapore to Conduct Translational Cell Therapy Research in Singapore

On July 27, 2025 Elpis Biopharmaceuticals, a clinical-stage cell therapy company developing bispecific armored CAR-T therapies for solid tumors, reported the signing of a Memorandum of Understanding (MOU) with the National Cancer Centre Singapore (NCCS) (Press release, Elpis Biopharmaceuticals, JUL 27, 2025, View Source [SID1234654557]). The partnership aims to support collaborative cell therapy research and clinical trials for the treatment of a variety of cancers, including colorectal, pancreatic and ovarian cancers. CAR-T cell therapy is a form of immunotherapy that is currently only approved for use to treat blood cancers, such as certain types of lymphomas and multiple myeloma.

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As part of the agreement, Elpis will contribute clinically validated technologies for cancer treatment, including multi-mechanism armor, bispecific targeting antibodies, cytokine cocktails, and a rapid mRNA display discovery engine, to drive the development of next-generation cell therapies. These technologies are already being investigated in Elpis’ global clinical trials of EPC-002 and EPC-003, with the goal of expanding their translational relevance across multiple tumor types. Plans are also underway for Elpis to establish a laboratory space at NCCS and co-share its equipment to enable more integrated and efficient collaboration.

"This partnership reflects our commitment to rapidly advancing innovative immunotherapies from discovery to clinical development through to regulatory review and, hopefully saving patients’ lives," said Yan Chen, MD, PhD, Founder and CEO of Elpis Biopharmaceuticals. "By combining Elpis’s proprietary technology with NCCS’s clinical expertise, we look forward to accelerating the delivery of these potential groundbreaking new cancer therapies to patients in Singapore and beyond."

NCCS will contribute its expertise in clinical research and access to clinical trial infrastructure to support the evaluation of novel cell therapy candidates.

"The potential of using cell therapies for solid tumors is still being explored, and this collaboration will enable us to evaluate promising new technologies in a clinical context to address current unmet needs and improve patient outcomes," said Professor Lim Soon Thye, CEO of NCCS.

"This is a key collaboration with NCCS’ precision immunotherapy program. With our respective strengths and the shared goal of transforming clinical care through translational science, we look forward to offering clinical trials and developing novel cell therapies to better meet the needs of patients in Singapore and the region," added Professor Daniel Tan, Head, Division of Clinical Trials and Epidemiological Sciences and Senior Consultant, NCCS.

The collaboration will support the development of bispecific armored CAR-T cell therapies for solid tumors, while Elpis’s global leading mRNA display technology will support NCCS in the rapid discovery of human antibodies to novel targets and enable novel modalities to cell therapy and beyond.

"The MOU represents an expansion of Elpis’s living drug strategy and a key step toward enabling broader clinical translation of our cutting-edge cell therapy technologies," said Chee-Yong Lim, Co-Founder, Co-CEO & Chief Strategy Officer, Elpis Biopharmaceuticals. "Together, we are working to make living drugs a reality for patients with cancers that currently lack effective treatment options."

Harbour BioMed Announces Positive Profit Alert for 2025 Interim Results

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."

Hengrui Pharma and GSK enter agreements to develop up to 12 innovative medicines across Respiratory, Immunology & Inflammation and Oncology

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.