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AC Immune is a Switzerland-based biopharmaceutical company focused on therapies and diagnostics for neurodegenerative diseases such as Alzheimer’s and Parkinson’s. It has no approved products and does not expect product revenue for several years, relying instead on R&D collaborations and funding.
The pipeline includes active immunotherapies ACI‑35.030, ACI‑24.060 and ACI‑7104.056, small molecule ACI‑19764 and Morphomer programs, and PET tracers PI‑2620, ACI‑12589, ACI‑15916 and ACI‑19626. Several assets have FDA Fast Track designation. Key partners include Eli Lilly, Janssen, Lantheus and Takeda.
The filing emphasizes extensive risks: clinical failure or delay, heavy dependence on partners, intense competition, IP and generic challenges, reimbursement pressures, ESG and climate rules, cybersecurity and data‑privacy exposure, pandemics, geopolitical shocks and new U.S. trade tariffs. As of the period end, 101,742,231 common shares were outstanding.
AC Immune SA has begun a Phase 1 clinical trial of ACI-19764, an orally administered small molecule that inhibits the NLRP3 inflammasome. The first healthy volunteer has been dosed, marking the program’s entry into human testing.
The Europe-based study will evaluate single and multiple ascending doses to assess safety, tolerability, pharmacokinetics, and pharmacodynamics, including drug levels in plasma and cerebrospinal fluid and inhibition of IL-1β as a measure of target engagement. Initial data are expected in the second half of 2026.
Preclinical data suggest ACI-19764 is highly brain penetrant and potent, with strong effects on neuroinflammation and weight control in animal models, supporting its potential in metabolic and neurological diseases such as Alzheimer’s, Parkinson’s, ALS and frontotemporal dementia.
AC Immune reported that partner Janssen has temporarily paused enrollment in the Phase 2b ReTain study of ACI-35.030/JNJ-2056 in preclinical Alzheimer’s disease while it evaluates aspects of the trial, including recruitment. The company states this voluntary pause is not due to new safety findings and that the trial’s pre-specified interim immunogenicity threshold was met.
The company says this pause does not affect its liquidity and that existing capital resources are expected to fund operations into Q3 2027, excluding any potential milestone payments. In 2026, AC Immune anticipates multiple clinical readouts from its active immunotherapy programs in Alzheimer’s and Parkinson’s disease and expects its ACI-19764 Phase 1 trial in healthy volunteers to start dosing imminently, with results anticipated in the second half of 2026. AC Immune also plans to report Q4 2025 earnings on March 12.
A planned insider sale of common stock has been disclosed under Rule 144. The person named in the notice, Andrea Pfeifer, plans to sell 30,000 shares of common stock through Morgan Stanley Smith Barney LLC on or around 01/15/2026, with an indicated aggregate market value of $110,100.00. The filing notes that 100,600,000 shares of this class are outstanding and lists NASDAQ as the securities exchange.
The shares to be sold were originally acquired on 06/01/2012 by exercising stock options issued by the company and paid for in cash. Over the past three months, there was a separate 10b5-1 sale for Andrea Pfeifer of 500 common shares on 10/29/2025 for gross proceeds of $2,000.00. By signing the notice, the seller represents that they are not aware of any undisclosed material adverse information about the issuer’s current or prospective operations.
AC Immune SA reported that it has positive interim safety and immunogenicity data from the Phase 2 VacSYn clinical trial of ACI-7104.056, its wholly owned anti‑alpha‑synuclein active immunotherapy for early Parkinson’s disease. The trial is evaluating this candidate in patients with early-stage Parkinson’s.
The company disclosed that these results were first shared in a press release dated December 11, 2025, which is attached as an exhibit to this Form 6-K for more detailed information.
AC Immune SA (ACIU) submitted a Form 144 notifying the proposed sale of 45,000 common shares through Morgan Stanley Smith Barney LLC on or about 10/03/2025 with an aggregate market value of $140,850.00. The filer acquired these shares on 06/01/2012 by previously exercised stock options and paid cash for them. The filing lists recent sales by the same account under 10b5-1 plans totaling multiple transactions between 07/24/2025 and 09/29/2025, including sales of 29,400 and 5,600 shares on 09/25/2025 and 09/29/2025, respectively. The filer attests no undisclosed material adverse information and includes standard Rule 144 representations.
AC Immune SA reports the outcome of a strategic review, deciding to concentrate spending on its most important R&D assets. The focus will be on three clinical-stage active immunotherapy programs, including two in collaborations with pharmaceutical partners, and on small molecule programs targeting NLRP3 and Tau.
To support this sharper focus, AC Immune plans to reduce its workforce by around 30%. The company states that these actions are expected to extend its available cash for operations to the end of the third quarter of 2027, giving it more time to advance its key pipeline programs.