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])

On November 4, 2025 Dispatch Bio, a biotechnology company developing a universal treatment for solid tumors, reported preclinical data supporting its first therapeutic program planned to enter the clinic, DISP-10, and its first-in-class Flare platform, at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) 2025 Annual Meeting.

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Immunotherapies have had limited success in solid tumors due to the lack of tumor-specific targets and a profoundly immunosuppressive microenvironment. Dispatch’s Flare platform addresses these barriers by systemically delivering a tumor-specific virus that paints a universal synthetic antigen (Flare) on tumor cells, enabling precise recognition by T cells, while reshaping the tumor microenvironment to support immune activity. Data presented at SITC (Free SITC Whitepaper) (Abstract 394) demonstrate strong and consistent tumor labeling, iterative viral amplification and tumor cell clearance across multiple epithelial tumor models.

"These data show that delivering engineered targets specifically to tumor cells allows us to control antigen specificity, while also reprogramming the tumor microenvironment," said Lex Johnson, Ph.D., Co-Founder and Chief Platform Officer. "We are excited to start with CAR T as our first program, and because the Flare approach is modular and not restricted to CAR T cells, it can be extended across multiple immunotherapy modalities."

The company also presented preclinical findings from DISP-10, its first therapeutic candidate (Abstract 393). DISP-10 pairs DV-10, a tumor-targeted virus expressing a modified BCMA antigen (dBCMA) and the immune-stimulatory cytokine IL-18 and chemokine CXCL9, with a clinically validated BCMA-directed CAR T. The viral component installs the target and drives local immune activation, enabling robust CAR T function in solid tumors. DISP-10 demonstrated potent anti-tumor responses in numerous in vitro and in vivo models, with no activity observed in healthy cells. Dispatch plans to initiate a first-in-human Phase 1 study in 2026 to evaluate DISP-10 across multiple solid tumor types.

"DISP-10 creates the right biological context for CAR T cells to function in solid tumors," said Barbra Sasu, Ph.D., Chief Scientific Officer. "The consistency of activity seen with various BCMA-targeted therapies across tumor models gives us confidence in its clinical potential."

(Press release, Dispatch Bio, NOV 4, 2025, View Source [SID1234659405])