AC Immune (NASDAQ: ACIU) details Alzheimer’s trial pause and 2027 cash runway

Rhea-AI Filing Summary

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.

Insights

Neuroscience & biotech strategy analyst

Partner trial enrollment pause introduces uncertainty but is framed as non-safety related while broader pipeline progresses.

The voluntary enrollment pause by Janssen in the Phase 2b ReTain study of ACI-35.030/JNJ-2056 focuses on trial aspects such as recruitment, with no new safety signal disclosed and a key interim immunogenicity threshold already met. This suggests the mechanism continues to show biological activity.

AC Immune emphasizes that its liquidity outlook remains unchanged, with capital expected to cover operations into Q3 2027 excluding milestones. At the same time, the company highlights upcoming 2026 clinical data from ACI-24.060 in Alzheimer’s disease, ACI-7104.056 in early Parkinson’s disease, and first-in-human work for inflammasome inhibitor ACI-19764, with Phase 1 results anticipated in the second half of 2026. Subsequent disclosures on Janssen’s evaluation of ReTain and these readouts will shape perceptions of portfolio strength.

UNITED STATES
SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

FORM 6-K

REPORT OF FOREIGN PRIVATE ISSUER PURSUANT TO RULE 13a-16 OR
15d-16 UNDER THE SECURITIES EXCHANGE ACT OF 1934

For the month of February 2026

Commission file number: 001-37891

AC IMMUNE SA

(Exact Name of Registrant as Specified in Its Charter)

EPFL Innovation Park
Building B
1015 Lausanne, Switzerland

(Address of Principal Executive Offices)

Indicate by check mark whether the registrant files or will file annual reports under cover of Form 20-F or
Form 40-F.

Form 20-F ☒     Form 40-F ☐

Corporate Update

AC Immune SA (the “Company”) has been informed by Janssen Pharmaceuticals, Inc. (“Janssen”), a Johnson & Johnson company, in relation to the Phase 2b study ReTain (NCT06544616) in which ACI-35.030/JNJ-2056 is now being assessed in subjects with preclinical (i.e., pre-symptomatic) Alzheimer’s disease that while the Phase 2b Retain trial continues, enrollment has been temporarily paused while Janssen evaluates aspects of the trial (including recruitment). The temporary pause in recruitment is voluntary and not related to new safety findings, and the trial’s pre-specified interim immunogenicity threshold was met.

The temporary pause in recruitment does not impact the Company’s current liquidity position.  In this regard, the Company currently believes that its existing capital resources, as previously indicated, will be sufficient to meet its projected operating requirements into Q3 2027, excluding any potential milestone payments.

During 2026, the Company anticipates reporting clinical results in relation to its other Active Immunotherapy programs, including interim 12-month results in the ABATE clinical trial of ACI-24.060 in Alzheimer’s disease patients (safety, immunogenicity and Abeta PET) as well as final data from Part 1 of the VacSYn Phase 2 clinical trial of ACI-7104.056 in early-stage Parkinson’s disease. Additionally, the Company’s program, ACI-19764, an NLRP3 inflammasome inhibitor, is imminently expected to start dosing healthy volunteers in a Phase 1 trial with results anticipated in the second half of 2026.

The Company will be reporting its Q4 2025 Earnings results on Thursday, March 12.  

This Report on Form 6-K shall be deemed to be incorporated by reference into the registration statements on Form F-3 (File Nos. 333-227016, 333-249655 and 333-277940) and Form S-8 (File Nos. 333-213865, 333-216539 and 333-233019) of AC Immune SA and to be a part thereof from the date on which this report is filed, to the extent not superseded by documents or reports subsequently filed or furnished.

SIGNATURE

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned, thereunto duly authorized.

	AC IMMUNE SA
	By:	/s/ Andrea Pfeifer
		Name:  Andrea Pfeifer
		Title:    Chief Executive Officer
	By:	/s/ Christopher Roberts
		Name:  Christopher Roberts
		Title:    Chief Financial Officer

Date:     February 17, 2026    

FAQ

What did AC Immune (ACIU) announce about the ReTain Phase 2b Alzheimer’s trial?

AC Immune reported that Janssen has temporarily paused enrollment in the ReTain Phase 2b study of ACI-35.030/JNJ-2056. The pause is voluntary, focuses on evaluating trial aspects such as recruitment, is not driven by new safety findings, and the interim immunogenicity threshold was met.

Is the temporary enrollment pause in ReTain linked to safety issues for AC Immune (ACIU)?

No, the company states the temporary pause in recruitment for the ReTain Phase 2b trial is not related to new safety findings. AC Immune also notes that the trial’s pre-specified interim immunogenicity threshold was achieved, indicating the vaccine candidate generated the targeted immune response.

How does the ReTain trial pause affect AC Immune’s (ACIU) cash runway?

AC Immune says the temporary pause in recruitment does not impact its current liquidity position. The company believes existing capital resources will be sufficient to meet projected operating requirements into Q3 2027, excluding any potential milestone payments from its collaborations or pipeline advances.

What clinical milestones does AC Immune (ACIU) expect in 2026 from its pipeline?

In 2026, AC Immune expects interim 12-month results from the ABATE trial of ACI-24.060 in Alzheimer’s disease, final Part 1 data from the VacSYn Phase 2 trial of ACI-7104.056 in early Parkinson’s, and Phase 1 results for inflammasome inhibitor ACI-19764 in healthy volunteers.

When will AC Immune (ACIU) report its Q4 2025 earnings results?

AC Immune plans to report its Q4 2025 earnings results on Thursday, March 12. This upcoming disclosure will provide updated financial information alongside the company’s stated expectation that its existing capital can fund operations into the third quarter of 2027.

What is AC Immune’s (ACIU) ACI-19764 program and current timeline?

ACI-19764 is AC Immune’s NLRP3 inflammasome inhibitor program. The company indicates this candidate is imminently expected to start dosing healthy volunteers in a Phase 1 trial, with initial clinical results from this first-in-human study anticipated in the second half of 2026.