On November 4, 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 a financial update and announced its cash position as of September 30, 2025.

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"MaaT Pharma is actively executing its financing strategy, building on the momentum of our outstanding Phase 3 results with Xervyteg in acute Graft-versus Host disease patients. With funding secured through February 2026, we are leveraging a balanced mix of dilutive and non-dilutive sources to support our development programs and preserve shareholder value. The recent partnership with Clinigen and the loan agreement with the European Investment Bank are key milestones in this strategy, providing capital-efficient solutions we intend to build upon to sustain our growth throughout 2026," said Eric Soyer, Chief Financial Officer of MaaT Pharma.

Corporate and Financing Update

In July 2025, the Company announced that it has secured a €37.5 million, 4-tranche loan 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, 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 allo-HSCT.
The Company announces the successful drawdown in October 2025 of Tranche A for an amount of €3.5 million, together with the issuance, in accordance with the terms of the 24th resolution of the shareholders’ meeting held on June 20, 2025 and Articles L. 228-91 and seq. of the French Commercial Code, of 468,772 warrants to the EIB with an exercise price of 4.5898€, as per the Loan and Warrant agreements with the EIB. The Tranche A loan is payable over two years after a grace period of 4 years, and bears an interest rate of 7% per annum.
In July 2025, the Company announced the signature of an exclusive license and distribution agreement with Clinigen, the global pathfinder accelerating access to critical medicines and a leading European player in hospital distribution and market access, to support market access to Xervyteg for 3rd-line aGvHD patients across Europe, should the submission for Marketing Authorisation be successful. With this partnership, MaaT Pharma demonstrates its capability to supply products to pharmaceutical companies, including those specializing in rare diseases while ensuring commercial scale-up.
The Company received an upfront payment of €10.5 million in July 2025 and may receive up to an additional €18 million, including €12 million upon Marketing Authorization approval and €6 million in commercial milestones. The Company is also eligible for royalty payments on net sales, with a rate in the mid-thirties, as well as recurring cash flows under the supply agreement, with products being sold to the partner at a pre-agreed price.
In September 2025, MaaT Pharma has been awarded the Innovative Company label ("Entreprise Innovante") by Bpifrance.
Cash position1

As of September 30, 2025, total cash and cash equivalents were EUR 22.4 million, as compared to EUR 15.0 million as of June 30, 2025, and EUR 20.2 million as of December 31, 2024.
The Company believes it has sufficient cash to cover its current operating needs and development programs until the end of February 2026.
Revenues in Q3 20251

MaaT Pharma reported revenues from France from its Early Access Program of EUR 1.0 million for the quarter ended September 30, 2025, a 56% increase over the third quarter of 2024. Total revenues for the first nine months of 2025 amounted to EUR 3.4 million compared with EUR 2.3 million for the same period of 2024, a year-over-year increase of 45%1, reflecting the continued demand from the medical community for MaaT Pharma’s drug candidate Xervyteg(MaaT013).
Upcoming financial communication*

March 30th, 2026 – Q4 and Full year 2025 financial results
*Indicative calendar that may be subject to change.

Upcoming investor and medical conferences participation

November 5-9, 2025 – 40th Society of Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) annual meeting in National Harbor, MD, USA
November 19-21, 2025 – Société Francophone de Greffe de Moelle et de Thérapie Cellulaire (SFGM-TC) annual meeting in Geneva, Switzerland
November 25, 2025 – Investir Day event in Paris, France
December 6-9, 2025 – 67th American Society of Hematology (ASH) (Free ASH Whitepaper) annual meeting in Orlando, Fl, USA

(Press release, MaaT Pharma, NOV 4, 2025, View Source [SID1234659404])

On November 4, 2025 AC Immune SA (NASDAQ: ACIU), a clinical-stage biopharmaceutical company pioneering precision therapeutics for neurodegenerative diseases, reported results for the quarter ended September 30, 2025, and provided a corporate update.

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Dr. Andrea Pfeifer, CEO of AC Immune SA, commented: "We have sharpened our investment focus on our most valuable assets following a strategic review. Our pipeline assets have the potential to transform treatment and enable prevention of neurodegenerative disease. Our active immunotherapies for precision prevention of neurodegenerative diseases continue to make strong progress through Phase 2 development in Alzheimer’s disease and Parkinson’s disease. These are complemented by novel small-molecule therapeutics targeting intracellular mechanisms of neurodegenerative diseases. Importantly, our recent pipeline prioritization has extended our cash runway to the end of Q3 2027, without including anticipated milestone payments from our existing collaborations or potential payments from new business development deals.

"We are now moving towards multiple value-inflection points. Further interim results from Part 1 of the VacSYn trial of ACI-7104.056, our wholly owned anti-alpha-synuclein active immunotherapy for Parkinson’s disease, are expected this quarter. Our two partnered active immunotherapy programs are continuing to progress according to plan. We also published data in The Lancet’s eBioMedicine on ACI-35.030 (JNJ-64042056) with the first clinical demonstration that our SupraAntigen platform generates highly differentiated active immunotherapies compared with other approaches, even with the same peptide sequence. This technology also powers our ACI-24.060 anti-Abeta active immunotherapy program, for which additional results are expected in H1 next year."

Q3 2025 and Subsequent Highlights:

● Following a strategic review by executive management, the Company sharpened its focused investment on its most important assets.
o These include its three clinical-stage active immunotherapy programs, two of which are in ongoing pharma collaborations, and its most promising small molecule programs targeting NLRP3, Tau and a-synuclein.
o As a result, the Company has reduced its workforce by around 30% and extended its cash for operations to the end of Q3 2027.
● AC Immune groundbreaking research results published in peer-reviewed journals including:
o the clinical results from the completed Phase 1b/2a trial of active immunotherapy ACI-35.030’s (JNJ-2056) partnered with Janssen Pharmaceuticals, Inc., a Johnson & Johnson company, in eBioMedicine.
o preclinical research demonstrating the in vivo activity of a vectorized (AAV9) anti-TDP-43 monoclonal antibody in a model of ALS/FTD, in Molecular Therapy.
o first-in-class positron emission tomography (PET) tracers for imaging TDP-43 pathology in the brain, including ACI-19626, that could enable a precision medicine approach to neurodegenerative diseases which are currently difficult to diagnose, in Nature Communications.
● Appointed Prof. Catherine Mummery, a deeply experienced neurologist and expert in dementia clinical trials, as a member and Chair of its Clinical Advisory Board (CAB).

Anticipated 2025 Milestones

Program

Milestone

Expected in

ACI-7104.056
anti-a-syn active immunotherapy

Further interim results from Part 1 of Phase 2 VacSYn trial in PD, including pharmacodynamics and biomarkers

Q4 2025

ACI-24.060
anti-Abeta active immunotherapy

ABATE Phase 2 trial reaches 12-month treatment timepoint in the AD3 cohort by year end (with interim results reported thereafter)

Q4 2025

ACI-19764
Small molecule NLRP3 inhibitor

IND/CTA filing

Q4 2025

Morphomer-Tau aggregation inhibitors

Lead declaration and initiation of IND-enabling studies

Q4 2025

Morphomer a-syn aggregation inhibitor

Lead declaration

Q4 2025

TDP-43-PET tracer

Initial Phase 1 readout in genetic frontotemporal dementia (FTD)

Q4 2025

ACI-15916
a-syn-PET tracer

Phase 1 readout in Parkinson’s disease (PD)

Q4 2025

Analysis of Financial Statements for the Quarter Ended September 30, 2025

● Cash position: The Company had total cash resources of CHF 108.5 million (CHF 165.5 million as of December 31, 2024), composed of CHF 27.7 million in cash and cash equivalents and CHF 80.7 million in short-term financial assets. The Company’s cash balance is expected to provide sufficient capital resources to the end of Q3 2027, excluding potential milestone payments.
● R&D expenditures: R&D expenses for the three months ended September 30, 2025, were CHF 13.1 million, compared with CHF 14.5 million for the comparable period in 2024. The decrease was primarily due to lower spend associated with the ACI-24.060 ABATE study during the period, as well as lower expenses incurred on ACI-7104.056. These reductions were offset by higher costs in our NLRP3 inhibitor program (ACI-19764).
● G&A expenditures: G&A expenses in the period were CHF 3.6 million, compared with CHF 3.8 million for the comparable period in 2024.
● Restructuring expenses: Expenses recognized as a result of the restructuring were CHF 0.5 million compared to nil for the comparable period in 2024. These expenses include CHF 2.1 million of termination benefits, offset by a CHF 1.8 million gain on curtailment in the defined benefit pension liability.

● Financial result: The financial result, net was a CHF 0.3 million gain for the three months ended September 30, 2025, compared to a CHF 1.8 million loss for the comparable period in 2024. This change was primarily driven by increased stability in foreign currency exchange differences in CHF versus foreign currencies, predominantly the U.S. Dollar.
● IFRS loss for the period: The Company reported a net loss after taxes of CHF 15.9 million for the three months ended September 30, 2025, compared with a net income of CHF 5.5 million for the comparable period in 2024. The change period over period derives primarily from the recognition of a CHF 24.6 million milestone in Q3 2024 under the collaboration with Janssen Pharmaceuticals, Inc.

(Press release, AC Immune, NOV 4, 2025, View Source [SID1234659339])

On November 4, 2025 FORE Biotherapeutics reported that the Company will participate at the following investor conferences:

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Stifel 2025 Healthcare Conference. The Company will attend on Tuesday, November 11, and will provide a corporate presentation at 10:40 a.m. – 11:10 a.m. ET.
Jefferies London Global Healthcare Conference. The Company will attend and participate in one-on-one meetings on Monday, November 17 – Wednesday, November 19.
Management will host and participate in one-on-one meetings. Please contact Argot Partners to schedule one-on-one meetings with the management team.

(Press release, Fore Biotherapeutics, NOV 4, 2025, View Source [SID1234659355])

On November 4, 2025 RAPT Therapeutics, Inc. (Nasdaq: RAPT), a clinical-stage immunology-based biopharmaceutical company focused on discovering, developing and commercializing novel therapies for patients living with inflammatory and immunological diseases, reported that members of the RAPT management team will participate in the following investor conferences in November:

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Guggenheim’s 2nd Annual Healthcare Innovation Conference – Fireside chat on Tuesday, November 11, 2025 at 3:30 p.m. ET

Stifel 2025 Healthcare Conference – Fireside chat on Wednesday, November 12, 2025 at 2:40 p.m. ET

TD Cowen Virtual Immunology & Inflammation Summit – Fireside chat on Thursday, November 13, 2025 at 2:30 p.m. ET
To access the live webcasts or subsequent archived recordings of the fireside chats, please visit the RAPT Therapeutics website at https://investors.rapt.com/events-and-presentations.

(Press release, RAPT Therapeutics, NOV 4, 2025, https://investors.rapt.com/news-releases/news-release-details/rapt-therapeutics-participate-multiple-upcoming-investor-0 [SID1234659371])

On November 4, 2025 Transgene (Euronext Paris: TNG), a biotech company that designs and develops virus-based immunotherapies for the treatment of cancer, reported a business update on its lead asset TG4050 developed from its myvac platform, upcoming plans, and its financial position as of September 30, 2025.

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TG4050 – INTV: New Data presented at SITC (Free SITC Whitepaper) supports TG4050’s potential role in preventing cancer relapse

Transgene and its partner NEC1 will jointly present a poster on additional immunological data profiling the neoantigen-specific T-cell response after treatment with TG4050 in head and neck cancer at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) Annual Meeting.

Comprehensive immunogenicity data confirm the ability of TG4050 monotherapy to induce neoantigen-specific cytotoxic CD8+ T-cell responses capable of targeting and eliminating tumor cells – see press release. These CD8+ T cells target multiple neoantigens encoded in the vaccine, have tissue resident cytosignature, and are still detectable up to two years after the start of TG4050 treatment. Overall, these data support the TG4050 mechanism of action that resulted in the reduction of risk of relapse observed in the randomized Phase I study.

These data have been generated from the randomized Phase I part of the ongoing Phase I/II trial evaluating TG4050 as a single agent in the adjuvant treatment of HPV-negative HNSCC, in patients that are in complete response following surgery and adjuvant (chemo-)radiotherapy.

These results follow the positive randomized Phase I data presented in a rapid oral presentation at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) (ASCO Annual Meeting – see press release).

The SITC (Free SITC Whitepaper) abstract is available both on the SITC (Free SITC Whitepaper) and Transgene websites. The poster presentation will take place on November 8 at the Conference and will be available on Transgene’s website following the presentation.

Transgene will host a webcast (in English) to discuss the SITC (Free SITC Whitepaper) data on November 14, 2025, from 10:00 a.m. to 11:00 a.m. ET (16:00 to 17:00 CET). The webcast and the replay will be available here and on Transgene‘s website.

Transgene expects to complete the randomization of patients with operable HNSCC in the Phase II part of the trial by early 2026. First immunogenicity data from this Phase II part are expected to be available in H2 2026. The first efficacy data (2-year disease-free survival, DFS) will become available as soon as all patients are evaluable for two-year DFS with either an event (relapse or death) or 2-year follow-up whichever occurs first.

Transgene is currently evaluating the most efficient regulatory pathway to accelerate the development of its lead asset, TG4050, with the goal of bringing it to patients with operable HNSCC as quickly as possible.

myvac platform: Potential to reduce the risk of relapse across multiple operable solid tumors

Transgene’s INTV platform, myvac, could be applied across a range of solid tumors where in many cases a significant unmet medical need remains. In parallel, Transgene is initiating start-up activities for a potential new Phase I trial in a second indication in an early treatment setting, with the aim of initiating once all conditions are met.

BT-001 (oncolytic virus – intratumoral administration): Updated Phase I/II data presented at ESMO (Free ESMO Whitepaper) 2025 demonstrated positive antitumoral activity

Transgene and BioInvent presented a poster on updated clinical results showing the positive antitumoral activity of BT-001 in patients with advanced refractory tumors at the 2025 European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Annual Meeting – see press release.

These updated data from the Phase I trial (NCT04725331) evaluating BT-001 in combination with MSD’s (Merck & Co., Inc., Rahway, NJ, USA) anti-PD-1 therapy, KEYTRUDA (pembrolizumab)2 showed positive local, abscopal and sustained antitumoral activity in injected and non-injected lesions. Immune-mediated tumor shrinkage is consistent with the mechanistic hypothesis that BT-001, in combination with pembrolizumab, turns "cold" tumors into immunologically active ones.

The poster is available on Transgene’s website.

Transgene and BioInvent are exploring clinical development opportunities for intratumoral administration of BT-001 in collaboration with clinicians.

Key financial elements

In millions of euros Q3
2025 2024
Research Tax Credit 5.8 4.8
Revenue from collaborative and licensing agreements 0.1 -
Other income 0.3 0.2
Operating income 6.13 5.0

During the third quarter of 2025, the Research Tax Credit increased to €5.8 million compared to €4.8 million for the same period in 2024, reflecting the progress of the ongoing Phase II part of the clinical trial evaluating TG4050 in head and neck cancer, with sustained patient enrollment and related expenses, including the manufacturing of individualized batches.

As of September 30, 2025, Transgene had €12.8 million in cash, compared to €16.7 million as of December 31, 2024.

Over the first nine months of 2025, Transgene’s net cash burn4 was €28.8 million (including the prefinancing of the 2024 Research Tax Credit for €5.2 million in June 2025) compared to €31.3 million for the same period in 2024.

Business funded until the end of December 2026

In March 2025, the Company signed a new amendment to the current account advance agreement with its major shareholder TSGH (Institut Mérieux), which increased the total amount of the facility by €15 million to €48 million. As of September 30, 2025, the Company has drawn down €35.5 million from this facility.

With this credit facility and the support of TSGH (Institut Mérieux), Transgene is able to fund its business until the end of December 2026, enabling the Company to deliver significant news flow on its myvac platform over the next 12 months.

(Press release, Transgene, NOV 4, 2025, View Source [SID1234659389])