On April 30, 2026 AC Immune SA (NASDAQ: ACIU), a clinical-stage biopharmaceutical company pioneering precision therapeutics for neurodegenerative diseases, reported financial and corporate updates for the quarter ended March 31, 2026.
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Dr. Andrea Pfeifer, CEO of AC Immune SA, commented: "The progress in our collaborations with Takeda and Eli Lilly reflect great confidence in our anti-Abeta active immunotherapy and Tau aggregation inhibitor small molecules, respectively. These have the potential to change the way we target the proteinopathies that drive Alzheimer’s and other neurodegenerative diseases (NDDs). This is further exemplified by the presentation of the interim results for ACI-7104 at AD/PD 2026 showing that our active immunotherapy targeting a-synuclein (a-syn) has the potential to modify disease pathology in Parkinson’s disease (PD). We also advanced our NLRP3 inhibitor ACI-19764 into clinical development, further demonstrating the power of AC Immune’s technology to target the key pathways that contribute to neurodegeneration.
"We are now moving towards multiple value inflection points during 2026. These include Phase 2 data readouts on our active immunotherapies ACI-7104 and ACI-24, and initial results from the Phase 1 trial of ACI-19764 also anticipated this year."
Q1 2026 and Subsequent Highlights:
ACI-24 anti-Abeta active immunotherapy
· As announced separately today, AC Immune has initiated the final cohort, AD4, in the ongoing Phase 1b/2 ABATE trial of ACI-24 to treat Alzheimer’s Disease
· Treatment of the first patient in cohort AD4 triggers a $12 million milestone payment from Takeda
Morphomer-Tau small molecule program
· Amended agreement with Eli Lilly and Co. (Lilly) reflects growing excitement for targeting intracellular Tau and significant progress with our Morphomer small molecules
· The amendment continues the research and collaboration to cover development of new lead Tau Morphomer candidates and potential back-up compounds.
· Under this amendment, AC Immune receives a CHF10 million upfront payment (Q2 2026 event) and a subsequent milestone payment subject to Phase 1 dosing, in addition to milestones announced in a prior amendment. AC Immune is eligible for further development, regulatory and commercial milestones of over CHF1.7 billion, plus tiered percentage royalty payments in the low double digits, as previously disclosed.
· Investigational New Drug (IND)-enabling studies are expected to be initiated imminently.
ACI-7104, anti-a-syn active immunotherapy
· Presented updated interim results from Part 1 of the Phase 2 VacSYn clinical trial in early-stage Parkinson’s disease at the International Conference on Alzheimer’s and Parkinson’s Diseases (AD/PD 2026), including promising biomarker data.
· Interim results previously presented include changes in biomarkers and clinical measures all suggesting potential disease modification through treatment with ACI-7104
· Final results for the week 104 full data set from Part 1 of the VacSYn trial expected to be reported in H2 2026.
NLRP3 inhibitor, ACI-19764, small molecule program
· Dosed the first subjects in a Phase 1 clinical trial of ACI-19764, a brain-penetrant Morphomer small molecule targeting the NLRP3 inflammasome.
· Morphomer NLRP3 inhibitors have potential to intervene at the earliest stages of disease in neurodegenerative conditions, including AD, PD, amyotrophic lateral sclerosis (ALS) and frontotemporal dementia.
· Potential additional indications include inflammatory disorders, cardiovascular disease, metabolic disorders, skin inflammatory diseases, and certain rare diseases, among others.
ACI-35 (JNJ-2056) anti-pTau active immunotherapy
· AC Immune’s partner Janssen Pharmaceuticals, Inc. (Janssen), a Johnson & Johnson company, is seeking a protocol amendment for the ReTain study to enable earlier insights into the biological activity of JNJ-2056 and its potential for clinical benefit. Submissions to all relevant health authorities are ongoing.
· The study remains active, with enrollment paused, and there is no change for enrolled participants at this time.
· The study is ongoing based on ~60 enrolled patients with a minimum of 12 months and up to 24 months of treatment and follow-up.
TDP-43 PET tracer
· Presented Phase 1 data including the first in vivo images of TDP-43 pathology in the human brain, detected using its first-in-class positron emission tomography (PET) tracer ACI-19626, at the International Conference on Alzheimer’s and Parkinson’s Disease (AD/PD 2026).
· Initial Phase 1 data (PET scans) with ACI-19626 showed that tracer uptake was significantly higher in key regions of the brain in patients with frontotemporal dementia (FTD) and we are currently evaluating the tracer in ALS patients.
· Clinical data indicate a pharmacokinetic (PK) profile suitable for human brain imaging and potentially pharmacodynamic analysis of therapeutics targeting TDP-43 pathology.
AC Immune AD/PDTM 2026 symposium
· Hosted an industry symposium on achieving precision prevention in Parkinson’s disease, highlighting Phase 2 clinical data on our ACI-7104 active immunotherapy, our small molecule programs targeting intracellular alpha-synuclein, and innovative diagnostic approaches to identifying at-risk individuals.
Anticipated 2026 Milestones
Program Milestone Expected in
ACI-7104.056
anti-a-syn active immunotherapy Final data from Part 1 of the Phase 2 VacSYn trial in PD H2 2026
ACI-24.060
anti-Abeta active immunotherapy Interim results from ABATE Phase 2 trial after reaching 12-month treatment timepoint in the AD3 cohort H1 2026
ACI-19764
NLRP3 inhibitor Results from Phase 1 trial in healthy volunteers H2 2026
Morphomer-Tau aggregation inhibitors Initiation of IND-enabling studies H1 2026
Morphomer a-syn aggregation inhibitor Lead declaration H1 2026
Analysis of Financial Statements for the Quarter Ended March 31, 2026
· Cash Position: The Company had total cash resources of CHF 74.8 million (CHF 91.4 million as of December 31, 2025), composed of CHF 19.2 million in cash and cash equivalents and CHF 55.6 million in short-term financial assets. The Company’s cash resources are expected to provide sufficient capital to last into Q4 2027, excluding potential milestone payments.
· R&D expenditures: R&D expenses for the three months ended March 31, 2026, were CHF 11.8 million, compared with CHF 15.9 million for the comparable period in 2025. The decrease was partly due to lower personnel and operational spend of approximately CHF 1.7 million as a result of our pipeline focus initiatives announced in Q3 2025, as well as lower spend associated with our active immunotherapy programs, particularly in the upfront CMC costs prior to initiation of phase 2 studies.
· G&A expenditures: G&A expenses in the period were CHF 4.2 million in the period ended March 31, 2026, compared to CHF 4.4 million for same period in 2025.
· Financial result: The financial result was a loss of less than CHF 0.1 million for the period, compared with a gain of CHF 0.3 million for the comparable period. The change was primarily driven by a decrease in interest income earned on short-term financial assets, partially offset by lower foreign exchange losses.
· IFRS loss for the period: The Company had a net loss of CHF 14.8 million for the period ended March 31, 2026, compared to CHF 19.0 million for the same period in 2025.
(Press release, AC Immune, APR 30, 2026, View Source [SID1234664957])