AC Immune Reports Second Quarter 2025 Financial Results and Provides a Corporate Update
AC Immune (NASDAQ: ACIU) reported Q2 2025 financial results and provided updates on its neurodegenerative disease pipeline. The company maintains a strong financial position with CHF 127.1 million in cash, providing runway into Q1 2027. Key highlights include positive interim results from the Phase 2 VacSYn trial of ACI-7104.056 for Parkinson's disease, showing a 20-fold increase in anti-α-syn antibodies.
The company has three active immunotherapies in Phase 2 development, including ACI-24.060 for Alzheimer's disease, with interim results expected in early 2026. Their NLRP3 inhibitor program (ACI-19764) has advanced to IND-enabling studies. Q2 financial results showed contract revenues of CHF 1.3 million and a net loss of CHF 21.2 million, improved from CHF 22.8 million in Q2 2024.
AC Immune (NASDAQ: ACIU) ha comunicato i risultati finanziari del secondo trimestre 2025 e aggiornamenti sul suo portafoglio di farmaci per le malattie neurodegenerative. L'azienda mantiene una solida posizione finanziaria con 127,1 milioni di CHF in liquidità, garantendo risorse fino al primo trimestre 2027. Tra i punti salienti, risultati intermedi positivi dalla fase 2 dello studio VacSYn con ACI-7104.056 per il morbo di Parkinson, che ha mostrato un aumento di 20 volte degli anticorpi anti-α-sinucleina.
La società ha tre immunoterapie attive in sviluppo di fase 2, tra cui ACI-24.060 per l'Alzheimer, con risultati intermedi attesi all'inizio del 2026. Il programma con inibitore NLRP3 (ACI-19764) è passato agli studi per l'abilitazione IND. I risultati finanziari del secondo trimestre mostrano ricavi da contratti per 1,3 milioni di CHF e una perdita netta di 21,2 milioni di CHF, migliorata rispetto ai 22,8 milioni di CHF del secondo trimestre 2024.
AC Immune (NASDAQ: ACIU) informó los resultados financieros del segundo trimestre de 2025 y proporcionó actualizaciones sobre su pipeline de enfermedades neurodegenerativas. La compañía mantiene una posición financiera sólida con 127,1 millones de CHF en efectivo, lo que le garantiza recursos hasta el primer trimestre de 2027. Entre los aspectos destacados, resultados intermedios positivos del ensayo VacSYn de fase 2 con ACI-7104.056 para la enfermedad de Parkinson, mostrando un aumento de 20 veces en anticuerpos anti-α-sinucleína.
La empresa cuenta con tres inmunoterapias activas en desarrollo de fase 2, incluyendo ACI-24.060 para la enfermedad de Alzheimer, con resultados intermedios esperados a principios de 2026. Su programa con inhibidor NLRP3 (ACI-19764) ha avanzado a estudios para habilitar IND. Los resultados financieros del segundo trimestre mostraron ingresos por contratos de 1,3 millones de CHF y una pérdida neta de 21,2 millones de CHF, mejorando respecto a los 22,8 millones de CHF del segundo trimestre de 2024.
AC Immune (NASDAQ: ACIU)� 2025� 2분기 재무 결과와 신경퇴행� 질환 파이프라� 업데이트� 발표했습니다. 회사� 1� 2,710� CHF� 현금� 보유하여 2027� 1분기까지 운영 자금� 확보� 탄탄� 재무 상태� 유지하고 있습니다. 주요 내용으로� 파킨슨병 치료� ACI-7104.056� 2� VacSYn 임상시험 중간 결과에서 � α-시누클레� 항체가 20� 증가� 긍정적인 결과가 포함되어 있습니다.
회사� 알츠하이머병 치료� ACI-24.060� 포함� 3개의 활성 면역치료�� 2� 개발 중이�, 중간 결과� 2026� 초에 발표� 예정입니�. NLRP3 억제� 프로그램(ACI-19764)은 IND 승인 준� 연구 단계� 진입했습니다. 2분기 재무 결과� 계약 수익 130� CHF와 순손� 2,120� CHF� 기록했으�, 이는 2024� 2분기 2,280� CHF 순손실에� 개선� 수치입니�.
AC Immune (NASDAQ : ACIU) a publié ses résultats financiers du deuxième trimestre 2025 et des mises à jour sur son pipeline de maladies neurodégénératives. L'entreprise conserve une solide position financière avec 127,1 millions de CHF en liquidités, assurant une visibilité jusqu'au premier trimestre 2027. Les points clés incluent des résultats intermédiaires positifs de l'essai VacSYn de phase 2 avec ACI-7104.056 pour la maladie de Parkinson, montrant une augmentation par 20 des anticorps anti-α-synucléine.
L'entreprise dispose de trois immunothérapies actives en développement de phase 2, dont ACI-24.060 pour la maladie d'Alzheimer, avec des résultats intermédiaires attendus début 2026. Leur programme d'inhibiteur NLRP3 (ACI-19764) est passé aux études préparatoires à l'IND. Les résultats financiers du deuxième trimestre ont montré des revenus contractuels de 1,3 million de CHF et une perte nette de 21,2 millions de CHF, une amélioration par rapport aux 22,8 millions de CHF du deuxième trimestre 2024.
AC Immune (NASDAQ: ACIU) meldete die Finanzergebnisse für das zweite Quartal 2025 und gab Updates zu seiner Pipeline für neurodegenerative Erkrankungen bekannt. Das Unternehmen verfügt über eine solide finanzielle Position mit 127,1 Millionen CHF an liquiden Mitteln, die bis zum ersten Quartal 2027 reichen. Zu den wichtigsten Highlights zählen positive Zwischenergebnisse der Phase-2-Studie VacSYn mit ACI-7104.056 bei Parkinson, die eine 20-fache Steigerung der Anti-α-Syn-Antikörper zeigten.
Das Unternehmen hat drei aktive Immuntherapien in der Phase-2-Entwicklung, darunter ACI-24.060 für Alzheimer, mit Zwischenergebnissen, die Anfang 2026 erwartet werden. Das NLRP3-Inhibitor-Programm (ACI-19764) hat die IND-fähigen Studien erreicht. Die Finanzergebnisse für Q2 zeigten Vertragsumsätze von 1,3 Millionen CHF und einen Nettoverlust von 21,2 Millionen CHF, was eine Verbesserung gegenüber 22,8 Millionen CHF im Q2 2024 darstellt.
- Strong cash position of CHF 127.1M provides runway into Q1 2027
- ACI-7104.056 showed 20-fold increase in anti-α-syn antibodies in Phase 2 trial
- Three active immunotherapies progressing in Phase 2 clinical development
- Net loss improved to CHF 21.2M from CHF 22.8M year-over-year
- Contract revenues increased to CHF 1.3M from CHF 0.7M in prior year
- Multiple programs still in early stages with no near-term revenue potential
- Significant ongoing R&D expenses of CHF 16.8M per quarter
- Key trial results for ABATE Phase 2 not expected until early 2026
Insights
AC Immune shows progress in neurodegenerative pipeline with strong cash runway, though quarterly losses continue amid advancing clinical trials.
AC Immune's Q2 2025 results demonstrate steady advancement of its neurodegenerative disease pipeline with three active immunotherapies in Phase 2 trials. The company's lead candidate, ACI-7104.056 for Parkinson's disease, showed encouraging interim data with a 20-fold increase in anti-α-synuclein antibodies and favorable safety profile—positive early signals for this wholly-owned asset.
From a financial perspective, AC Immune maintains a solid cash position of CHF 127.1 million (USD 157.6 million), providing runway into Q1 2027 without additional milestone payments. This represents a burn rate of approximately CHF 38.4 million for the first half of 2025 compared to their December 2024 position, suggesting disciplined capital management while advancing multiple clinical programs.
The company reported a quarterly net loss of CHF 21.2 million, slightly improved from CHF 22.8 million in the comparable period, with R&D expenses at CHF 16.8 million and reduced G&A costs at CHF 3.9 million. Contract revenues were minimal at CHF 1.3 million, primarily from their Takeda partnership.
AC Immune's strategy focuses on precision prevention through a diversified approach targeting key proteins in neurodegeneration (α-synuclein, Abeta, tau, TDP-43). With multiple data readouts expected in H2 2025, including interim results from the Phase 2 VacSYn trial, the company is approaching several potential value inflection points. Their expansion into inflammasome inhibition with the NLRP3 program (ACI-19764) now in IND-enabling studies represents a strategic broadening of their therapeutic approach.
The key near-term catalyst remains the additional interim data from ACI-7104.056 expected later this year, which could trigger the initiation of Part 2 of the VacSYn study and accelerate the path to pivotal trials for their Parkinson's candidate.
AC Immune's immunotherapy pipeline shows promising progress with strong early immunogenicity data in neurodegenerative diseases.
AC Immune's therapeutic approach targeting the prevention of neurodegenerative diseases through active immunization represents a promising strategy addressing a critical medical need. Their anti-α-synuclein active immunotherapy (ACI-7104.056) for Parkinson's disease is demonstrating encouraging preliminary efficacy with a 20-fold increase in α-synuclein antibodies after just four immunizations. This robust immunogenicity is particularly noteworthy in a field where generating sufficient antibody responses has been challenging.
The company's three-pronged active immunotherapy approach targeting distinct pathological proteins (α-synuclein for Parkinson's, Abeta and tau for Alzheimer's) reflects a sophisticated understanding of the complex pathophysiology underlying neurodegenerative disorders. Each target represents a distinct pathological pathway, allowing for potential combination approaches or precision targeting based on patient-specific pathology profiles.
Their expansion into small molecule NLRP3 inhibition with ACI-19764 now in IND-enabling studies is particularly significant. The inflammasome pathway represents a critical neuroinflammatory mechanism contributing to multiple neurodegenerative conditions. By combining antibody-based approaches with small molecule inhibitors of neuroinflammation, AC Immune is pursuing a comprehensive strategy addressing both protein misfolding and inflammatory components of neurodegeneration.
The company's diagnostic portfolio, including PET tracers for TDP-43 and α-synuclein, complements their therapeutic pipeline by potentially enabling earlier and more precise diagnosis. The emphasis on biomarker development alongside their therapeutic programs suggests a forward-thinking approach to patient selection and therapeutic monitoring.
While clinical outcomes data remains pending, the immunogenicity and safety profile observed thus far provide an encouraging signal. The multiple readouts expected in H2 2025 will be critical in determining whether these strong immune responses translate to meaningful clinical benefits in slowing disease progression.
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 development
- ACI-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 2025
- Third 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 2026
- Small molecule NLRP3 program now in IND-enabling studies, highlighting promise in early-stage pipeline
- Cash 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 , 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 .
- AC Immune hosted an highlighting the company’s industry-leading pipeline of active immunotherapies for precision prevention of neurodegenerative diseases.
Anticipated 2025 Milestones
Program | Milestone | Expected in |
ACI-24.060 anti-Abeta active immunotherapy | ABATE Phase 2 trial reaches 12-month treatment timepoint in the AD3 cohort by year end (with interim results reported thereafter) | H2 2025 |
ACI-7104.056 anti-a-syn active immunotherapy | Interim pharmacodynamic and biomarker results from Part 1 of Phase 2 VacSYn trial in PD | H2 2025 |
ACI-19764 Small molecule NLRP3 inhibitor | IND/CTA filing | H2 2025 |
TDP-43 monoclonal antibody | Validated pharmacodynamic assay for clinical readout | H2 2025 |
Morphomer-Tau aggregation inhibitors | Lead declaration and initiation of IND-enabling studies | H2 2025 |
Morphomer a-syn aggregation inhibitor | Lead declaration | H2 2025 |
TDP-43-PET tracer | Initial Phase 1 readout | H2 2025 |
ACI-15916 a-syn-PET tracer | Phase 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.
AboutAC Immune SA
AC Immune SAis 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 Immunehas 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 >
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:
SVP,Investor Relations& Corporate Communications Gary Waanders, Ph.D., MBA AC Immune Phone: +41 21 345 91 91 :[email protected] | |
International Media Chris Maggos Cohesion Bureau Phone: +41 79 367 6254 :[email protected] |
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 theSecurities and Exchange Commission. Forward-looking statements speak only as of the date they are made, andAC Immunedoes 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)
Asof | ||||
June30, | December31, | |||
2025 | 2024 | |||
Assets | ||||
Non-current assets | ||||
Property, plant and equipment | 2,490 | 2,651 | ||
Right-of-use assets | 4,926 | 5,437 | ||
Intangible asset | 50,416 | 50,416 | ||
Long-term financial assets | 584 | 415 | ||
Total non-current assets | 58,416 | 58,919 | ||
Current assets | ||||
Prepaid expenses | 2,542 | 4,302 | ||
Accrued income | 510 | 1,099 | ||
Other current receivables | 1,621 | 1,104 | ||
Short-term financial assets | 101,413 | 129,214 | ||
Cash and cash equivalents | 25,722 | 36,275 | ||
Total current assets | 131,808 | 171,994 | ||
Total assets | 190,224 | 230,913 | ||
Shareholders' equity and liabilities | ||||
Shareholders� equity | ||||
Share capital | 2,236 | 2,226 | ||
Share premium | 479,680 | 478,506 | ||
Treasury 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 | 4,560 | ||
Long-term lease liabilities | 3,880 | 4,401 | ||
Net employee defined benefit liabilities | 9,036 | 8,844 | ||
Total non-current liabilities | 16,512 | 17,805 | ||
Current liabilities | ||||
Trade and other payables | 2,729 | 2,658 | ||
Accrued expenses | 11476 | 12098 | ||
Short-term deferred contract revenue | 83,725 | 85,056 | ||
Short-term lease liabilities | 1,039 | 1,026 | ||
Total current liabilities | 98,969 | 100,838 | ||
Total liabilities | 115,481 | 118,643 | ||
Total 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 June30, | ||||
2025 | 2024 | 2025 | 2024 | ||
Revenue | |||||
Contract revenue | 1,306 | 687 | 2,296 | 687 | |
Total revenue | 1,306 | 687 | 2,296 | 687 | |
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), net | 28 | 41 | 21 | 109 | |
Total operating expenses | (20,694) | (21,648) | (41,055) | (41,716) | |
Operating loss | (19,388) | (20,961) | (38,759) | (41,029) | |
Financial income | 458 | 739 | 1,145 | 1,368 | |
Financial 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 attributable to 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 June30, | ||||
2025 | 2024 | 2025 | 2024 | ||
Loss for the period | (21,189) | (22,760) | (40,218) | (40,622) | |
Items that will be reclassified to income or loss in subsequent periods (net of tax): | |||||
Currency translation differences | 4 | � | 9 | 16 | |
Items 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 | � | 9 | 16 | |
Total comprehensive loss, net of tax | (21,185) | (22,760) | (40,209) | (40,606) |
Attachment
