AC Immune Reports First Quarter 2025 Financial Results and Provides a Corporate Update
AC Immune reported Q1 2025 financial results, highlighting strong progress in its neurodegenerative disease therapeutics pipeline. The company maintains a solid cash position of CHF 145.7 million, providing funding into Q1 2027.
Key developments include positive interim Phase 2 results for ACI-7104.056, their anti-alpha-synuclein immunotherapy for Parkinson's disease, showing strong immunogenicity and favorable safety. The treatment induced anti-a-syn antibodies over 20-fold higher than placebo levels after four immunizations.
Q1 2025 financials show R&D expenses of CHF 15.9 million (up from CHF 15.2 million in Q1 2024) and G&A expenses of CHF 4.4 million (down from CHF 5.0 million). The company reported a net loss of CHF 19.0 million, compared to CHF 17.9 million in the same period last year.
Multiple milestones are expected throughout 2025, including additional Phase 2 data readouts and potential trial initiations across their therapeutic portfolio.
AC Immune ha comunicato i risultati finanziari del primo trimestre 2025, evidenziando significativi progressi nel suo portafoglio di terapie per le malattie neurodegenerative. L'azienda mantiene una solida posizione di cassa di 145,7 milioni di CHF, garantendo finanziamenti fino al primo trimestre 2027.
Tra gli sviluppi principali si segnalano risultati intermedi positivi della Fase 2 per ACI-7104.056, la loro immunoterapia anti-alfa-sinucleina per il morbo di Parkinson, che mostra forte immunogenicità e un profilo di sicurezza favorevole. Il trattamento ha indotto anticorpi anti-a-sinucleina oltre 20 volte superiori rispetto ai livelli del placebo dopo quattro somministrazioni.
I dati finanziari del primo trimestre 2025 indicano spese per R&S pari a 15,9 milioni di CHF (in aumento rispetto ai 15,2 milioni del primo trimestre 2024) e spese generali e amministrative di 4,4 milioni di CHF (in calo rispetto ai 5,0 milioni). L'azienda ha riportato una perdita netta di 19,0 milioni di CHF, rispetto ai 17,9 milioni dello stesso periodo dell'anno precedente.
Nel corso del 2025 sono previsti diversi traguardi, tra cui ulteriori dati di Fase 2 e potenziali avvii di nuovi studi clinici nel loro portafoglio terapeutico.
AC Immune informó los resultados financieros del primer trimestre de 2025, destacando un sólido avance en su cartera de terapias para enfermedades neurodegenerativas. La compañía mantiene una posición de efectivo sólida de 145,7 millones de CHF, asegurando financiamiento hasta el primer trimestre de 2027.
Los desarrollos clave incluyen resultados intermedios positivos de la Fase 2 para ACI-7104.056, su inmunoterapia anti-alfa-sinucleína para la enfermedad de Parkinson, que muestra una fuerte inmunogenicidad y un perfil de seguridad favorable. El tratamiento indujo anticuerpos anti-a-sinucleína más de 20 veces superiores a los niveles del placebo tras cuatro inmunizaciones.
Las finanzas del primer trimestre de 2025 muestran gastos en I+D de 15,9 millones de CHF (frente a 15,2 millones en el primer trimestre de 2024) y gastos generales y administrativos de 4,4 millones de CHF (por debajo de los 5,0 millones). La compañía reportó una pérdida neta de 19,0 millones de CHF, comparado con 17,9 millones en el mismo periodo del año anterior.
Se esperan múltiples hitos a lo largo de 2025, incluyendo nuevas lecturas de datos de Fase 2 y posibles inicios de ensayos en su portafolio terapéutico.
AC Immune는 2025년 1분기 재무 결과를 발표하며 신경퇴행성 질환 치료제 파이프라인에서 강력한 진전을 보였다고 밝혔습니다. 회사는 1억 4570만 스위스 프랑(CHF)의 견고한 현금 보유고를 유지하고 있어 2027년 1분기까지 자금이 확보되어 있습니다.
주요 발전 사항으로는 파킨슨병을 위한 알파-시누클레인 항체 면역치료제 ACI-7104.056의 2상 중간 결과가 긍정적으로 나타났으며, 강한 면역원성과 우수한 안전성을 보였습니다. 이 치료는 4회 면역 접종 후 위약 대비 20배 이상의 항-알파-시누클레인 항체를 유도했습니다.
2025년 1분기 재무 내역은 연구개발비가 1590만 CHF로 2024년 1분기 1520만 CHF에서 증가했고, 일반관리비는 440만 CHF로 500만 CHF에서 감소했습니다. 순손실은 1900만 CHF로 작년 동기 1790만 CHF에 비해 늘어났습니다.
2025년 동안 추가 2상 데이터 발표와 치료제 포트폴리오 전반에 걸친 임상시험 개시 가능성 등 여러 이정표가 기대됩니다.
AC Immune a publié ses résultats financiers du premier trimestre 2025, soulignant des progrès significatifs dans son pipeline de traitements pour les maladies neurodégénératives. L'entreprise dispose d'une trésorerie solide de 145,7 millions de CHF, assurant un financement jusqu'au premier trimestre 2027.
Parmi les développements clés figurent des résultats intermédiaires positifs de la phase 2 pour ACI-7104.056, leur immunothérapie anti-alpha-synucléine pour la maladie de Parkinson, montrant une forte immunogénicité et une bonne tolérance. Le traitement a induit des anticorps anti-a-synucléine plus de 20 fois supérieurs aux niveaux du placebo après quatre immunisations.
Les résultats financiers du premier trimestre 2025 montrent des dépenses en R&D de 15,9 millions de CHF (en hausse par rapport à 15,2 millions au premier trimestre 2024) et des frais généraux et administratifs de 4,4 millions de CHF (en baisse par rapport à 5,0 millions). L'entreprise a enregistré une perte nette de 19,0 millions de CHF, contre 17,9 millions sur la même période l'année précédente.
Plusieurs jalons sont attendus tout au long de 2025, incluant des nouvelles données de phase 2 et de potentielles lancements d'essais cliniques dans leur portefeuille thérapeutique.
AC Immune meldete die Finanzergebnisse für das erste Quartal 2025 und hob dabei bedeutende Fortschritte in seiner Pipeline für Therapeutika bei neurodegenerativen Erkrankungen hervor. Das Unternehmen verfügt über eine solide Barreserve von 145,7 Millionen CHF, die die Finanzierung bis zum ersten Quartal 2027 sichert.
Zu den wichtigsten Entwicklungen zählen positive Zwischenergebnisse der Phase 2 für ACI-7104.056, ihre Anti-Alpha-Synuclein-Immuntherapie für Parkinson, die eine starke Immunogenität und ein günstiges Sicherheitsprofil zeigt. Die Behandlung induzierte Anti-a-Syn-Antikörper, die nach vier Immunisierungen mehr als 20-fach höher waren als die Placebo-Werte.
Die Finanzen des ersten Quartals 2025 zeigen F&E-Ausgaben von 15,9 Millionen CHF (gegenüber 15,2 Millionen CHF im ersten Quartal 2024) und Verwaltungsaufwand von 4,4 Millionen CHF (gegenüber 5,0 Millionen CHF). Das Unternehmen verzeichnete einen Nettoverlust von 19,0 Millionen CHF, verglichen mit 17,9 Millionen CHF im gleichen Zeitraum des Vorjahres.
Für 2025 werden mehrere Meilensteine erwartet, darunter weitere Datenveröffentlichungen der Phase 2 und mögliche Studienstarts im gesamten therapeutischen Portfolio.
- Strong cash position of CHF 145.7M providing runway into Q1 2027
- Positive Phase 2 interim results for ACI-7104.056 showing strong immunogenicity and favorable safety profile
- Treatment with ACI-7104.056 achieved 20-fold higher anti-a-syn antibodies vs placebo
- Multiple clinical milestones expected throughout 2025 across pipeline
- Successful completion of in vivo proof-of-concept study for morADC platform
- Cash decreased from CHF 165.5M (Dec 2024) to CHF 145.7M (Mar 2025)
- Increased net loss to CHF 19.0M in Q1 2025 vs CHF 17.9M in Q1 2024
- R&D expenses increased to CHF 15.9M from CHF 15.2M year-over-year
Insights
AC Immune reports solid cash position of CHF 145.7M providing runway into Q1 2027, despite increased quarterly loss of CHF 19M.
AC Immune's Q1 2025 financials present a stable financial foundation with
The net loss widened marginally to
The financial structure supports multiple value-inflection opportunities throughout 2025, including interim data from the ACI-7104.056 Phase 2 program in Parkinson's disease (Q2 2025) and potential initiation of Part 2 of the VacSYn trial (H2 2025). The mature pipeline with multiple clinical-stage candidates creates several shots on goal, potentially diversifying risk while providing multiple paths to value creation.
Promising immunogenicity data for AC Immune's Parkinson's immunotherapy shows 20-fold antibody increase; efficacy biomarker data pending in Q2.
The interim Phase 2 results for ACI-7104.056, AC Immune's anti-alpha-synuclein active immunotherapy, demonstrate encouraging immunological responses in early Parkinson's disease patients. The data shows antibody responses were rapidly induced after just two immunizations and subsequently boosted with each additional dose. Most significantly, treatment induced anti-alpha-synuclein antibodies at levels more than 20-fold higher than placebo background, indicating robust target engagement.
While these immunogenicity results are promising, the critical pharmacodynamic and biomarker data expected in Q2 2025 will be more indicative of potential therapeutic efficacy. These upcoming results will help determine whether the antibody response translates to meaningful biological effects on disease progression markers.
AC Immune's active immunotherapy approach for neurodegenerative diseases represents a differentiated strategy focusing on precision prevention rather than symptom management. The company's pipeline includes two additional Phase 2 active immunotherapy programs (ACI-24.060 and ACI-35.030) advancing in Alzheimer's disease trials.
The pipeline is further bolstered by early-stage assets highlighted at the AD/PD™ 2025 conference, including Morphomer® small molecules targeting alpha-synuclein and tau, and a novel Morphomer®-antibody drug conjugate platform that completed in vivo proof-of-concept. The multiple diagnostic PET tracers for TDP-43 and alpha-synuclein with readouts expected in H2 2025 could become valuable companion diagnostics for their therapeutic programs.
AC Immune Reports First Quarter 2025 Financial Results and Provides a Corporate Update
- Continuing to advance clinical active immunotherapy portfolio for precision prevention of neurodegenerative diseases
- Positive immunogenicity and good safety in interim results for wholly owned anti-alpha-synuclein (a-syn) active immunotherapy ACI-7104.056 in Phase 2 trial in Parkinson’s disease (PD)
- Additional ACI-7104.056 Phase 2 interim results (pharmacodynamics and biomarkers) expected in Q2 2025
- Presentations at International Conference on Alzheimer’s and Parkinson’s Disease (AD/PD™ 2025) highlight leadership in active immunotherapy and promising data on early-stage assets
- Cash resources of CHF 145.7 million as of March 31, 2025 provide funding into Q1 2027 before any potential milestones
Lausanne, Switzerland, April 30, 2025 -- AC Immune SA (NASDAQ: ACIU), a clinical-stage biopharmaceutical company pioneering precision therapeutics for neurodegenerative diseases, today reported results for the quarter ended March 31, 2025, and provided a corporate update.
Dr. Andrea Pfeifer, CEO of AC Immune SA, commented: “AC Immune’s portfolio of active immunotherapies for precision prevention of neurodegeneration continues to advance in clinical development. Our interim Phase 2 data on ACI-7104.056, our wholly owned a-syn active immunotherapy, demonstrated strong immunogenicity and a favorable safety profile in early Parkinson’s disease patients, further supporting its best-in-class characteristics. Our two partnered active immunotherapy programs, ACI-24.060 and ACI-35.030, also advanced well in their respective ongoing Phase 2 trials. Furthermore, we highlighted progress with our promising early-stage assets in presentations of preclinical data at AD/PD™ 2025, including Morphomer® small molecule drugs targeting a-syn and Tau, and Morphomer®-antibody drug conjugates (morADC) our new class of drug candidates for neurodegenerative diseases.”
“AC Immune is well financed into Q1 2027, without including significant potential milestones. We are moving towards several value-inflection points throughout 2025, including pharmacodynamic and biomarker data on ACI-7104.056 and potential initiation of Part 2 of the Phase 2 VacSYn trial, reaching the 12-month treatment timepoint for all the Alzheimer’s disease (AD) cohorts (including AD3 where enrollment was completed in December 2024) of the Phase 2 ABATE trial of ACI-24.060, and further developments across our early-stage pipeline.”
Q1 2025 and Subsequent Highlights:
- Additional 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.
- Antibody responses were rapidly induced against the target antigen after 2 immunizations and were further boosted by each subsequent immunization.
- Treatment with ACI-7104.056 induced an increase in anti-a-syn antibodies on average more than 20-fold higher than the placebo background level after four immunizations.
- Based on further interim results to be reported later in 2025, including pharmacodynamic and biomarker data, 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.
- In vivo proof-of-concept study of proprietary morADC platform was completed in Q1.
- 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
| Program | Milestone | Expected in |
| ACI-24.060 anti-Abeta active immunotherapy | ABATE Phase 2 trial reaches 12-month treatment timepoint in the AD3 cohort (with interim results reported shortly thereafter) | H2 2025 |
| ACI-7104.056 anti-a-syn active immunotherapy | Further interim results from Part 1 of Phase 2 VacSYn trial in PD, including pharmacodynamics and biomarkers | Q2 2025 |
| Initiation of Part 2 of VacSYn trial | H2 2025 | |
| ACI-19764 Small molecule NLRP3 inhibitor | Lead declaration and initiation of IND-enabling studies | Q2 2025 |
| 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 in genetic frontotemporal dementia (FTD) | 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 March 31, 2025
- Cash position: The Company had total cash resources of CHF 145.7 million (CHF 165.5 million as of December 31, 2024), composed of CHF 20.0 million in cash and cash equivalents and CHF 125.7 million in short-term financial assets. The Company’s cash balance provides sufficient capital resources into Q1 2027, without including potential milestones.
- R&D expenditures: R&D expenses in the period were CHF 15.9 million, compared with CHF 15.2 million for the comparable period in 2024. The expenses for the period were comprised mostly of ongoing clinical trial costs as well as personnel costs (including share-based payments), and regulatory, quality assurance, and intellectual property costs.
- G&A expenditures: G&A expenses in the period were CHF 4.4 million, compared with CHF 5.0 million for the comparable period in 2024.
- IFRS loss for the period: The Company reported a net loss after taxes of CHF 19.0 million for the three months ended March 31, 2025, compared with a net loss of CHF 17.9 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 >
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: gary.waanders@acimmune.com | |
| International Media Chris Maggos Cohesion Bureau Phone: +41 79 367 6254 Email: chris.maggos@cohesionbureau.com |
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 | ||||
| March 31, | December 31, | |||
| 2025 | 2024 | |||
| Assets | ||||
| Non-current assets | ||||
| Property, plant and equipment | 2,761 | 2,651 | ||
| Right-of-use assets | 5,186 | 5,437 | ||
| Intangible asset | 50,416 | 50,416 | ||
| Long-term financial assets | 585 | 415 | ||
| Total non-current assets | 58,948 | 58,919 | ||
| Current assets | ||||
| Prepaid expenses | 3,607 | 4,302 | ||
| Accrued income | 925 | 1,099 | ||
| Other current receivables | 1,988 | 1,104 | ||
| Short-term financial assets | 125,654 | 129,214 | ||
| Cash and cash equivalents | 19,960 | 36,275 | ||
| Total current assets | 152,134 | 171,994 | ||
| Total assets | 211,082 | 230,913 | ||
| Shareholders' equity and liabilities | ||||
| Shareholders’ equity | ||||
| Share capital | 2,230 | 2,226 | ||
| Share premium | 478,999 | 478,506 | ||
| Treasury shares | (218) | (218) | ||
| Currency translation differences | (1) | (5) | ||
| Accumulated losses | (386,212) | (368,239) | ||
| Total shareholders’ equity | 94,798 | 112,270 | ||
| Non-current liabilities | ||||
| Long-term deferred contract revenue | 3,956 | 4,560 | ||
| Long-term lease liabilities | 4,142 | 4,401 | ||
| Net employee defined benefit liabilities | 8,940 | 8,844 | ||
| Total non-current liabilities | 17,038 | 17,805 | ||
| Current liabilities | ||||
| Trade and other payables | 2,391 | 2,658 | ||
| Accrued expenses | 11146 | 12098 | ||
| Short-term deferred contract revenue | 84,676 | 85,056 | ||
| Short-term lease liabilities | 1,033 | 1,026 | ||
| Total current liabilities | 99,246 | 100,838 | ||
| Total liabilities | 116,284 | 118,643 | ||
| Total shareholders’ equity and liabilities | 211,082 | 230,913 | ||
Condensed Consolidated Statements of Income/(Loss) (Unaudited)
(In CHF thousands, except for per-share data)
| For the Three Months | ||||
| Ended March 31, | ||||
| 2025 | 2024 | |||
| Revenue | ||||
| Contract revenue | 990 | — | ||
| Total revenue | 990 | — | ||
| Operating expenses | ||||
| Research & development expenses | (15,916) | (15,165) | ||
| General & administrative expenses | (4,443) | (4,971) | ||
| Other operating income/(expense), net | (1) | 68 | ||
| Total operating expenses | (20,360) | (20,068) | ||
| Operating loss | (19,370) | (20,068) | ||
| Financial income | 687 | 629 | ||
| Financial expense | (54) | (36) | ||
| Exchange differences | (292) | 1,613 | ||
| Finance result, net | 341 | 2,206 | ||
| Loss before tax | (19,029) | (17,862) | ||
| Income tax expense | — | — | ||
| Loss for the period | (19,029) | (17,862) | ||
| Loss per share: | (0.19) | (0.18) | ||
Condensed Consolidated Statements of Comprehensive Income/(Loss) (Unaudited)
(In CHF thousands)
| For the Three Months | ||||
| Ended March 31, | ||||
| 2025 | 2024 | |||
| Loss for the period | (19,029) | (17,862) | ||
| Items that will be reclassified to income or loss in subsequent periods (net of tax): | ||||
| Currency translation differences: | 4 | 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) | — | — | ||
| Total comprehensive loss, net of tax | (19,025) | (17,846) | ||
Attachment
FAQ
What are the key findings from ACIU's Phase 2 VacSYn trial for Parkinson's disease in Q1 2025?
How long will ACIU's current cash position of CHF 145.7M last?
What are ACIU's major clinical milestones expected for 2025?
How did ACIU's financial performance change in Q1 2025 vs Q1 2024?
What progress has ACIU made with its Parkinson's disease treatment ACI-7104.056?
