AC Immune Reports Second Quarter 2025 Financial Results and Provides a Corporate Update

AC Immune Reports Second Quarter 2025 Financial Results and Provides a Corporate Update Three active immunotherapies for precision prevention of neurodegeneration progressing through Phase 2 clinical developmentACI-7104.056 anti-alpha-synuclein active immunotherapy in Parkinson’s disease produced strong immunogenicity and favorable safety profile in interim results from the ongoing Phase 2 VacSYn reported in April, with further data to come in H2 2025Third Alzheimer’s disease cohort (AD3) in the Phase 2 ABATE trial of anti-Abeta ACI-24.060 to reach 12 months of treatment in December 2025, with interim results expected early 2026Small molecule NLRP3 program now in IND-enabling studies, highlighting promise in early-stage pipelineCash resources of CHF 127.1 million (USD157.6 million) as of June 30, 2025, provide funding into Q1 2027 excluding any potential milestone payments Lausanne, Switzerland, August 5, 2025 -- AC Immune SA (NASDAQ: ACIU), a clinical-stage biopharmaceutical company pioneering precision therapeutics for neurodegenerative diseases, today reported results for the quarter ended June 30, 2025, and provided a corporate update. Dr. Andrea Pfeifer, CEO of AC Immune SA, commented: “AC Immune is continuing to progress toward precision prevention of neurodegenerative diseases as we approach multiple value-inflection points through the rest of 2025 and beyond. Our industry symposium during the AD/PD™ conference focused on unlocking active immunotherapy for tailored prevention strategies highlighted the momentum of our three active immunotherapies in Phase 2 development. Interim results on ACI-7104.056, our wholly owned a-syn active immunotherapy, reinforced its best-in-class characteristics, showing strong immunogenicity and a favorable safety profile in early Parkinson’s disease. The two partnered programs, ACI-24.060 and ACI-35.030, are also progressing according to plan. In addition, our Morphomer® small molecule drugs targeting a-syn and tau and Morphomer®-antibody drug conjugates (morADC) were featured in several presentations at AD/PD™ 2025. In our exciting early-stage pipeline, ACI-19764, a novel Morphomer® small molecule inhibitor of NLRP3, has now entered studies to enable an Investigational New Drug (IND) filing. “Our strong cash position provides funding into 2027, excluding potential milestone payments, and enables us to advance our robust pipeline focused on precision prevention of neurodegenerative diseases. Further interim results from Part 1 of the VacSYn trial of ACI-7104.056 are expected later this year, and the AD3 cohort in the ABATE trial of ACI-24.060 will reach 12 months of treatment around year end, with interim results thereafter. We also expect to file an IND for ACI-19764 this year.” Q2 2025 and Subsequent Highlights: Reported interim safety and positive immunogenicity data from the Phase 2 VacSYn clinical trial evaluating ACI-7104.056, AC Immune’s wholly owned anti-a-syn active immunotherapy candidate, for the treatment of patients with early PD. As presented at AD/PD™ 2025, treatment with ACI-7104.056 induced an average 20-fold increase in anti-a-syn antibodies after four immunizations compared to placebo background level.Based on pharmacodynamic and biomarker interim results to be reported later this year, AC Immune may decide to initiate Part 2 of VacSYn, with the aim of establishing early proof-of-concept and identification of disease-specific biomarkers for rapid transition into a pivotal study. AC Immune’s therapeutic and diagnostic programs were featured in multiple presentations at AD/PD™ 2025.AC Immune hosted an industry symposium highlighting the company’s industry-leading pipeline of active immunotherapies for precision prevention of neurodegenerative diseases. Anticipated 2025 Milestones ProgramMilestoneExpected inACI-24.060anti-Abeta active immunotherapyABATE Phase 2 trial reaches 12-month treatment timepoint in the AD3 cohort by year end (with interim results reported thereafter)H2 2025ACI-7104.056anti-a-syn active immunotherapyInterim pharmacodynamic and biomarker results from Part 1 of Phase 2 VacSYn trial in PDH2 2025ACI-19764Small molecule NLRP3 inhibitorIND/CTA filingH2 2025TDP-43monoclonal antibodyValidated pharmacodynamic assay for clinical readoutH2 2025Morphomer-Tau aggregation inhibitorsLead declaration and initiation of IND-enabling studiesH2 2025Morphomer a-syn aggregation inhibitorLead declarationH2 2025TDP-43-PET tracerInitial Phase 1 readoutH2 2025ACI-15916a-syn-PET tracerPhase 1 readout in Parkinson’s disease (PD)H2 2025 Analysis of Financial Statements for the Quarter Ended June 30, 2025 Cash Position: The Company had a total cash balance of CHF 127.1 million (CHF 165.5 million as of December 31, 2024), composed of CHF 25.7 million in cash and cash equivalents and CHF 101.4 million in short-term financial assets. The Company’s cash balance provides sufficient capital resources into Q1 2027, excluding potential milestone payments.Contract Revenues: The Company recorded CHF 1.3 million in contract revenues for the three months ended June 30, 2025, compared to CHF 0.7 million in the comparable prior period. For the three months ended June 30, 2025, our contract revenues of CHF 1.3 million were related to the efforts made under the agreement with Takeda.R&D Expenditures: R&D expenses for the three months ended June 30, 2025, were CHF 16.8 million compared to CHF 17.1 million in the comparable period in 2024. The decrease was primarily due to reduced activity in early-stage discovery programs, as well as lower expenses incurred on ACI-7104.056. These reductions were offset by higher costs in the Morphomer Inflammasome program (ACI-19764).G&A Expenditures: G&A expenses, in comparison to the comparable period in 2024, decreased by CHF 0.7 million to CHF 3.9 million for the 3 months ended June, 30, 2025. The decrease was primarily driven by a decrease in legal fees related to business development and licensing activities which were executed in the prior period.IFRS Loss for the Period: The Company reported a net loss after taxes of CHF 21.2 million for the three months ended June 30, 2025, compared with a net loss of CHF 22.8 million for the comparable period in 2024. About AC Immune SA AC Immune SA is a clinical-stage biopharmaceutical company and a global leader in precision prevention for neurodegenerative diseases, including Alzheimer’s disease, Parkinson’s disease, and NeuroOrphan indications driven by misfolded proteins. The Company’s two clinically validated technology platforms, SupraAntigen® and Morphomer®, fuel its broad and diversified pipeline of first- and best-in-class assets, which currently features a range of therapeutic and diagnostic programs, including candidates in Phase 2 and Phase 3 development. AC Immune has a strong track record of securing strategic partnerships with leading global pharmaceutical companies, resulting in substantial non-dilutive funding to advance its proprietary programs and >$4.5 billion in potential milestone payments plus royalties. SupraAntigen® is a registered trademark of AC Immune SA in the following territories: AU, EU, CH, GB, JP, RU, SG and USA. Morphomer® is a registered trademark of AC Immune SA in CN, CH, EU, GB, JP, KR, NO, RU and SG. The information on our website and any other websites referenced herein is expressly not incorporated by reference into, and does not constitute a part of, this press release. For further information, please contact: Forward looking statements This press release contains statements that constitute “forward-looking statements” within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. Forward-looking statements are statements other than historical fact and may include statements that address future operating, financial or business performance or AC Immune’s strategies or expectations. In some cases, you can identify these statements by forward-looking words such as “may,” “might,” “will,” “should,” “expects,” “plans,” “anticipates,” “believes,” “estimates,” “predicts,” “projects,” “potential,” “outlook” or “continue,” and other comparable terminology. Forward-looking statements are based on management’s current expectations and beliefs and involve significant risks and uncertainties that could cause actual results, developments and business decisions to differ materially from those contemplated by these statements. These risks and uncertainties include those described under the captions “Item 3. Key Information – Risk Factors” and “Item 5. Operating and Financial Review and Prospects” in AC Immune’s Annual Report on Form 20-F and other filings with the Securities and Exchange Commission. Forward-looking statements speak only as of the date they are made, and AC Immune does not undertake any obligation to update them in light of new information, future developments or otherwise, except as may be required under applicable law. All forward-looking statements are qualified in their entirety by this cautionary statement. Condensed Consolidated Balance Sheets (Unaudited)(In CHF thousands) As of June 30, December 31, 2025 2024Assets Non-current assets Property, plant and equipment 2,490 2,651Right-of-use assets 4,926 5,437Intangible asset 50,416 50,416Long-term financial assets 584 415Total non-current assets 58,416 58,919 Current assets Prepaid expenses 2,542 4,302Accrued income 510 1,099Other current receivables 1,621 1,104Short-term financial assets 101,413 129,214Cash and cash equivalents 25,722 36,275Total current assets 131,808 171,994Total assets 190,224 230,913 Shareholders' equity and liabilities Shareholders’ equity Share capital 2,236 2,226Share premium 479,680 478,506Treasury shares (218) (218)Currency translation differences 4 (5)Accumulated losses (406,959) (368,239)Total shareholders’ equity 74,743 112,270 Non-current liabilities Long-term deferred contract revenue 3,596 4,560Long-term lease liabilities 3,880 4,401Net employee defined benefit liabilities 9,036 8,844Total non-current liabilities 16,512 17,805 Current liabilities Trade and other payables 2,729 2,658Accrued expenses 11476 12098Short-term deferred contract revenue 83,725 85,056Short-term lease liabilities 1,039 1,026Total current liabilities 98,969 100,838Total liabilities 115,481 118,643Total shareholders’ equity and liabilities 190,224 230,913 Condensed Consolidated Statements of Income/(Loss) (Unaudited)(In CHF thousands, except for per-share data) For the Three Months Ended June 30, For the Six Months Ended June 30, 20252024 20252024Revenue Contract revenue1,306687 2,296687Total revenue1,306687 2,296687 Operating expenses Research & development expenses(16,826)(17,138) (32,742)(32,303)General & administrative expenses(3,896)(4,551) (8,334)(9,522)Other operating income/(expense), net2841 21109Total operating expenses(20,694)(21,648) (41,055)(41,716)Operating loss(19,388)(20,961) (38,759)(41,029) Financial income458739 1,1451,368Financial expense(50)(34) (103)(70)Exchange differences(2,209)(2,504) (2,501)(891)Finance result, net(1,801)(1,799) (1,459)407 Loss before tax(21,189)(22,760) (40,218)(40,622)Income tax expense—— ——Loss for the period(21,189)(22,760) (40,218)(40,622) Loss per share: Basic and diluted loss per share for the period attributableto equity holders(0.21)(0.23) (0.4)(0.41) Condensed Consolidated Statements of Comprehensive Income/(Loss) (Unaudited)(In CHF thousands) For the Three Months Ended June 30, For the Six Months Ended June 30, 20252024 20252024Loss for the period(21,189)(22,760) (40,218)(40,622)Items that will be reclassified to income or loss insubsequent periods (net of tax): Currency translation differences4— 916Items that will not to be reclassified to income or loss in subsequent periods (net of tax): Remeasurement gains on defined-benefit plans (net of tax)—— ——Other comprehensive income/(loss)4— 916Total comprehensive loss, net of tax (21,185)(22,760) (40,209)(40,606) 20250805__ACIU 2Q25 Earnings PR_Final

AC Immune Reports Second Quarter 2025 Financial Results and Provides a Corporate Update

FAQ

Why Bullish?

How important is it?

Why Long Term?

Related Companies

Related News