AC Immune Reports Full Year 2025 Financial Results and Provides a Corporate Update
-- Phase 2 interim results suggest treatment with active immunotherapy
ACI-7104 may slow the progression of Parkinson's disease
-- NLRP3 inhibitor ACI-19764 Phase 1 trial initiated with first participants
dosed
-- Approaching multiple value-inflection points, including interim results
of the AD3 cohort in the Phase 2 ABATE trial of ACI-24 in Alzheimer's
disease in H1 2026, and full 24-month data from Part 1 of the Phase 2
VacSYn trial of ACI-7104 in Q3 2026
-- Cash resources of CHF 91.4 million as of December 31, 2025, provide
funding to the end of Q3 2027 before any potential milestone payments
Lausanne, Switzerland, March 13, 2026 -- AC Immune SA $(ACIU)$, a clinical-stage biopharmaceutical company pioneering precision therapeutics for neurodegenerative diseases, today reported results for the full year ended December 31, 2025, and provided a corporate update.
Dr. Andrea Pfeifer, CEO of AC Immune SA, commented: "We made significant progress towards delivering precision prevention of neurodegenerative diseases in 2025, exemplified by the exceptional interim data from the VacSYn trial of ACI-7104, our wholly-owned active immunotherapy targeting <ALPHA>-synuclein. Evidence that ACI-7104 appears to slow the rate of progression in early Parkinson's disease $(PD)$ further demonstrates the potential for active immunotherapies as disease-modifying treatments with the potential to slow or prevent neuronal damage."
"Our novel Morphomer$(R)$ small-molecule therapeutics complement these programs by targeting intracellular mechanisms, enabling intervention at the earliest stages of disease. ACI-19764, a brain-penetrant NLRP3 inhibitor with potential to treat numerous diseases both within and beyond neurodegeneration, is now in a Phase 1 trial."
Full Year 2025 and Subsequent Highlights:
ACI-7104 anti-<ALPHA>-synuclein active immunotherapy
-- Reported positive interim safety and efficacy results from Part 1 of the
Phase 2 VacSYn trial of our wholly-owned anti-<ALPHA>-synuclein active
immunotherapy ACI-7104 in early PD.
-- Results suggest, for the first time, that targeting underlying
<ALPHA>-synuclein pathology with an active immunotherapy may slow the
rate of progression of Parkinson's disease.
-- These results could translate into a shift from treating symptoms toward
true disease modification in PD
-- Clear safety profile with no clinically relevant safety issues reported
to date
-- Targets met for immunogenicity (100% responder rate), pharmacodynamic
effect, target engagement and clinical assessments
-- Final data from Part 1 of the study expected in mid-2026.
Morphomer-Tau small molecule program
-- Progressed the Morphomer small molecule Tau aggregation inhibitors for
the potential treatment of Alzheimer's disease $(AD)$ and other
neurodegenerative diseases.
-- Investigational New Drug $(IND)$-enabling studies are expected to begin in
H1 2026.
NLRP3 inhibitor, ACI-19764, small molecule program
-- Dosed the first participants in a Phase 1 clinical trial of ACI-19764, a
brain-penetrant small molecule targeting the NLRP3 inflammasome
(NCT07463196).
-- Our 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 (e.g.,
multiple sclerosis, inflammatory bowel disease, gout), cancer,
cardiovascular disease, metabolic disorders (e.g., Type 2 diabetes,
obesity), skin inflammatory diseases (e.g. hidradenitis suppurativa) and
rare genetic syndromes of autoimmunity such as Cryopyrin-associated
periodic syndromes $(CAPS)$.
-- ACI-19764, an orally available, brain-penetrant NLRP3 inhibitor is a
major addition to AC Immune's growing intracellular targeting pipeline.
Sharpened Pipeline Focus with Operational Efficiencies Extending Cash Runway
-- Following a strategic review by executive management, sharpened
investment on our most important assets.
-- These include the three clinical-stage active immunotherapy programs
ACI-7104, ACI-24 and ACI-35, the latter two of which are in ongoing
pharma collaborations, and promising small molecule programs targeting
NLRP3, Tau and <ALPHA>-synuclein.
-- The Company reduced its workforce by around 30% and extended its cash for
operations to the end of Q3 2027.
AC Immune research results published in peer-reviewed journals and presented at conferences:
-- Clinical results from the completed Phase 1b/2a trial of active
immunotherapy ACI-35 (JNJ-2056) partnered with Janssen Pharmaceuticals,
Inc., a Johnson & Johnson company, in eBioMedicine.
-- 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.
-- 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.
-- Featured the company's therapeutic and diagnostic programs in
presentations at AD/PD$(TM)$ 2025 where we also hosted an industry
symposium highlighting the company's leading pipeline of active
immunotherapies for precision prevention of neurodegenerative diseases.
Appointed Prof. Catherine Mummery, a renowned neurologist and expert in dementia clinical trials, as Chair of Ac Immune's Clinical Advisory Board (CAB).
Anticipated 2026 Milestones
Program Milestone Expected in
-------------------------------- ------------------------------- -----------
ACI-7104 anti-<ALPHA>-synuclein Final data from Part 1 of the H2 2026
active immunotherapy Phase 2 VacSYn trial in PD
expected in mid-2026
-------------------------------- ------------------------------- -----------
ACI-24 Interim results from ABATE H1 2026
anti-Abeta active immunotherapy Phase 2 trial after reaching
12-month treatment timepoint in
the AD3 cohort
-------------------------------- ------------------------------- -----------
ACI-19764 Results from Phase 1 trial in H2 2026
NLRP3 inhibitor healthy volunteers
------------------------------- -----------
Morphomer-Tau aggregation Lead declaration and initiation H1 2026
inhibitors of IND-enabling studies
-------------------------------- ------------------------------- -----------
Morphomer <ALPHA>-synuclein Lead declaration H1 2026
aggregation inhibitor
-------------------------------- ------------------------------- -----------
Analysis of Financial Statements for the Full Year Ended December 31, 2025
-- Cash Position: The Company had total cash resources of CHF 91.4 million
as of December 31, 2025, compared to total cash resources of CHF 165.5
million as of December 31, 2024. The Company's cash balance provides
sufficient capital resources into Q3 2027, assuming no other milestones.
-- Contract Revenues: The Company recorded CHF 3.6 million in contract
revenues for the year ended December 31, 2025, compared with CHF 27.3
million in the prior year. For the year ended December 31, 2025, our
contract revenues of CHF 3.6 million were related to the efforts made
under the agreement with Takeda for development, CMC, and regulatory
activities. The decrease compared to the prior year relates to the
recognition of the second ReTain-related milestone payment of CHF 24.6
million under the agreement with Janssen in 2024.
-- R&D Expenditures: R&D expense decreased by CHF 6.1 million for the year
ended December 31, 2025 to CHF 56.4 million, predominantly due to:
-- Discovery and preclinical expenses: Decrease of CHF 1.6 million,
primarily due to the completion of certain pre-clinical studies
and our strategic focus on advancing clinical-stage programs.
-- Clinical expenses: Decrease of CHF 4.4 million, primarily due to
lower costs related to manufacturing activities for our Phase 2
VacSYn study evaluating ACI-7104 in early PD and certain
non-recurring manufacturing costs in 2024. These changes were
offset by increased costs associated with our NLRP3 inhibitor
program, which entered clinical development in 2026, and higher
costs associated with our PET Tracer programs.
-- Salary- and benefit-related costs: Decrease of CHF 0.7 million,
primarily due to decreased share-based compensation in the current
year.
-- G&A Expenditures: G&A expenses decreased by CHF 1.1 million for the year
ended December 31, 2025, to CHF 16.1 million. This decrease is primarily
due to legal fees in 2024 which did not recur.
-- Restructuring Expenditures: Expenses recognized as a result of the
restructuring were CHF 0.5 million compared to nil for the year ended
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. The remaining balance pertains to other non-cash
activities within share-based compensation.
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