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 Imugene Limited (ASX:IMU), a clinical-stage immuno-oncology company, reported that an abstract regarding azer-cel has been selected for oral presentation at the 67th American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting and Exposition, to be held from 6-9 December 2025 in Orlando, Florida.

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The ASH (Free ASH Whitepaper) Annual Meeting is the world’s premier event in malignant and non-malignant haematology, attracting more than 30,000 clinicians, scientists, and industry representatives from over 100 countries. Each year, the meeting highlights the most significant scientific and clinical advances in the field, with oral abstracts representing the highest tier of accepted submissions.

Imugene’s abstract, titled "Azer-cel, an allogeneic (allo) CD19 CAR T, in combination with low-dose interleukin-2 (IL-2) demonstrates clinical activity in patients with large B-cell lymphoma (LBCL) who relapsed after autologous (auto) CAR T", has been selected for presentation within the session "Cellular Immunotherapies: Early Phase Clinical Trials and Toxicities: Next Generation CAR-T Clinical Trials in Relapsed/Refractory B-cell NonHodgkin Lymphoma and Multiple Myeloma."

The oral presentation will take place on Saturday 6 December 2025, from 2:30pm to 2:45pm US Eastern Time in West Hall D2 of the Orange County Convention Center.

The abstract published overnight includes clinical activity and safety data from the Company’s azer-cel (allogeneic CD19 CAR T) program, evaluating the combination with low-dose IL-2 in patients with relapsed or refractory large B-cell lymphoma (LBCL) following prior autologous CAR T-cell therapy. The abstract is linked on Imugene’s website at View Source

Imugene’s Managing Director and Chief Executive Officer, Leslie Chong, said: "We are honoured that azer-cel has been selected for oral presentation at ASH (Free ASH Whitepaper), it being the world’s leading haematology conference. This puts a spotlight on the growing clinical interest in allogeneic CAR T approaches and represents an exciting opportunity to share new insights from our ongoing study with the global haematology community."

(Press release, Imugene, NOV 4, 2025, View Source [SID1234659294])

On November 3, 2025 Geekgene Biotechnology reported the company has received Investigational New Drug (IND) clearance from China’s National Medical Products Administration (NMPA) Center for Drug Evaluation (CDE) for GK01.

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(Press release, Geekgene Biotechnology, NOV 3, 2025, View Source [SID1234662198])

On November 3, 2025 Jecho Laboratories, Inc. reported it will present emerging preclinical data on JLC059, a novel GPC3/PD-L1 bispecific antibody drug conjugate (bsADC) at the 16th Annual World ADC Congress. GPC3 is a tumor-associated antigen highly expressed in liver and other solid tumors, while PD-L1 plays a key role in suppressing immune responses. JLC059 is composed of a fast-internalizing anti-GPC3 arm and a non-internalizing anti-PD-L1 arm, which enables targeted delivery of a cytotoxic payload to tumors and disrupts immunosuppressive signaling while minimizing toxicity to immune cells.

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The World ADC Congress will be held November 3-6, 2025 in San Diego, CA.

Details on the presentation are below:

Abstract 8: JLC059, a novel GPC3/PD-L1 bsADC integrating checkpoint inhibition for enhanced anti-tumor activity

Abstract Presentation Number: 8
Session Time: Tuesday, November 4, 2025 viewing 10:00 a.m. – 5:00 p.m. PST
Location: Town & Country, San Diego

(Press release, Jecho Laboratories, NOV 3, 2025, View Source [SID1234660000])

On November 3, 2025 Estrella Immunopharma, Inc. (NASDAQ: ESLA) ("Estrella" or the "Company"), a clinical stage biopharmaceutical company developing CD19 and CD22-targeted ARTEMIS T-cell therapies to treat cancer and autoimmune diseases, reported the successful completion of the second dose cohort in Phase I portion of its STARLIGHT-1 Phase I/II clinical trial of EB103, a CD19-redirected ARTEMIS T-cell therapy to treat patients with Advanced B-Cell Non-Hodgkin’s Lymphomas (NHL).

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Key Findings:

The study has achieved a 100% complete response (CR) rate at Month 1 in all evaluable patients treated in the second dose cohort.
All patients treated are considered high-risk group who are not suitable to receive commercial CD19 products, including one with Central Nervous System (CNS) lymphoma. No treatment-related serious adverse events (SAEs) were reported during this study phase.
"Completing the second dose cohort with a 100% CR rate marks a significant milestone in our EB103 clinical program," said Cheng Liu, PhD, Chief Executive Officer of Estrella. "We’re especially encouraged by the favorable safety profile observed in this high-risk group, including a CNS-involved patient, which demonstrates the potential of EB103 as a safe and effective treatment for a broader population of cancer patients who have limited options. We look forward to taking EB103 into the dose expansion phase of STARLIGHT-1."

The second dose cohort included patients with relapsed/refractory B-cell NHL who have failed multiple prior lines of therapy. Following the completion of this dose cohort, a Data and Safety Monitoring Board (DSMB) will review the cumulative study data to evaluate the safety and efficacy of EB103, and to determine the Recommended Phase II Dose (RP2D) for the expansion phase. The DSMB is an independent group of experts that assesses the study’s progress and makes recommendations to the trial’s sponsor.

The Phase I/II clinical trial for EB103 is an open-label, dose escalation, multi-center, Phase I/II clinical trial to assess the safety of EB103 autologous T-cell therapy and to determine RP2D in adult subjects (≥ 18 years of age) who have relapsed/refractory (R/R) B-cell NHL. The study includes a dose escalation phase followed by an expansion phase. Further details of the trial can be found at www.clinicaltrials.gov under NCT identifier: NCT06343311.

About EB103

EB103, a T-cell therapy, also referred to as Estrella’s "CD19-Redirected ARTEMIS T-Cell Therapy," utilizes ARTEMIS technology licensed from Eureka Therapeutics, Inc. ("Eureka"), Estrella’s parent company. Unlike a traditional CAR-T cell, the unique design of an ARTEMIS T-Cell, like EB103 T-cell, allows it to be activated and regulated upon engagement with cancer targets that use a cellular mechanism more closely resembling the one from an endogenous T-cell receptor. Once infused, EB103 T cells bind to and destroy CD19-positive cancer cells.

(Press release, Estrella Biopharma, NOV 3, 2025, View Source [SID1234659309])