Key Highlights

• ACI-7104 received FDA Fast Track Designation and IND clearance, with positive week-100 Phase 2 trial data in Parkinson's disease

• Phase 1 trial of NLRP3 inhibitor ACI-19764 showed positive interim safety and tolerability results in healthy volunteers

• Lead candidate declared in the Morphomer small molecule program targeting intracellular alpha-synuclein

• Cash resources stood at CHF 73.9 million as of September 30, 2026, providing runway into Q1 2028

AC Immune SA(NASDAQ:ACIU), a clinical-stage biopharma company focused on misfolded proteins driving neurodegenerative diseases, disclosed its third-quarter 2026 financial and corporate update on November 4, 2026. The quarter saw meaningful clinical and regulatory milestones across the company's wholly-owned pipeline, particularly in its programs targeting alpha-synuclein (a-syn) — a protein closely linked to Parkinson's disease.

Pipeline Developments in Parkinson's Disease

The headline achievement for AC Immune during the quarter was the progress of ACI-7104, its anti-a-syn active immunotherapy. The company reported positive safety and immunogenicity data through week-100 of the VacSYn Phase 2 trial, which is evaluating ACI-7104 in patients with early-stage Parkinson's disease. The trial demonstrated a 100% response rate after three immunizations, along with confirmed antibody penetration into the cerebrospinal fluid and preliminary signals for target engagement. Exploratory analyses also identified potential associations between antibody levels and disease activity measures. Additionally, ACI-7104 received FDA Fast Track designation and clearance of its Investigational New Drug application during the period. The company plans to have further data available before year-end on the characterization of ACI-7104-induced antibodies and their a-syn binding properties, with discussions with the FDA regarding the future development path planned for early 2027.

Progress Across the Broader Pipeline

Beyond ACI-7104, AC Immune advanced its Morphomer small molecule program by selecting a lead candidate drug targeting intracellular a-syn. In vitro results confirmed the candidate's ability to inhibit a-syn aggregation, and preclinical development has been initiated. Meanwhile, the company's NLRP3 inhibitor ACI-19764 — a brain-penetrant small molecule — delivered positive results from its Phase 1 clinical trial, showing the compound was safe and well-tolerated in healthy volunteers across single and multiple ascending dose cohorts, with confirmed cerebrospinal fluid penetration. Based on pharmacokinetic data, the therapeutic dose is expected to be no more than 10 mg once daily. A Phase 1b trial evaluating ACI-19764's anti-inflammatory activity in patients with cardiovascular disease risk is ongoing, with initial results anticipated early in 2027.

Q3 2026 Financial Performance

On the financial front, AC Immune reported total revenues of CHF 3.2 million for the third quarter of 2026, up from CHF 0.9 million in the same period of 2025. The increase was driven by recognition of revenues under the Takeda arrangements, including additional consideration for the AD4 Cohort. Research and Development expenses declined to CHF 9.9 million from CHF 13.1 million a year earlier, partly reflecting lower personnel and operational spend of CHF 2.2 million and a CHF 1.9 million decrease in discovery and preclinical programs following a prior-year restructuring. General and administrative expenses remained relatively flat at CHF 3.5 million. The net loss for the quarter narrowed to CHF 8.8 million from CHF 15.9 million in Q3 2025. The company held total cash resources of CHF 73.9 million as of September 30, 2026, compared to CHF 91.4 million at the end of 2025, expected to provide sufficient Capital into Q1 2028 excluding potential milestone payments.

Corporate Governance Changes

On the governance side, Tom Graney was elected to the Board of Directors at the Extraordinary General Meeting held on October 2 and joined the Audit and Finance Committee. Carl June stepped down from the Board after several years of service.

Looking Ahead

AC Immune heads into the final stretch of 2026 with several data readouts on the horizon. Characterization data for ACI-7104-induced antibodies is expected before year-end, while Phase 1b results for ACI-19764 in patients with elevated hsCRP are anticipated in the first half of 2027. With a cash runway extending into Q1 2028 and multiple clinical catalysts in the near term, the company continues to advance its portfolio of neurodegenerative disease programs.