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AC Immune SA

ACIU
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Business Summary

AC Immune SA is a clinical-stage biopharmaceutical company focused on developing Precision Medicine for neurodegenerative diseases, leveraging its proprietary SupraAntigen and Morphomer technology platforms . The company's business model is centered on generating revenue through upfront and milestone payments from collaboration agreements and grants, as it currently has no products approved for commercial sale . The primary customer segments are patients with neurodegenerative conditions such as Alzheimer's disease (AD) and Parkinson's disease (PD), with a strategic focus on early detection and disease prevention .

The company's product development strategy is driven by two core value drivers: Active Immunotherapies and intracellular targeting with brain-penetrant small molecule programs . The SupraAntigen platform is used for biological and immunological product candidates, generating conformation-specific antibodies for immunotherapy by presenting target antigens on liposome surfaces . The Morphomer platform is designed for small molecule development, selecting compounds that bind to and inhibit the aggregation of misfolded pathological proteins inside cells, and also promote disaggregation of existing aggregates .

Key product and service lines include several clinical-stage active immunotherapies and small molecule drugs. ACI-7104.056, a wholly-owned active immunotherapy targeting pathological alpha-synuclein (a-syn) for early Parkinson's disease, is in a Phase 2 study (VacSYn) . ACI-24.060, an anti-Abeta active immunotherapy for prodromal AD and AD in Down Syndrome (DS), is in a Phase 1b/2 trial (ABATE) and is subject to an exclusive option and license agreement with Takeda Pharmaceuticals USA, Inc. . ACI-35.030 (JNJ-64042056/JNJ-2056), an anti-phosphorylated-Tau (anti-pTau) active immunotherapy developed with Janssen Pharmaceuticals, Inc., is in a Phase 2b study (ReTain) for preclinical AD . Small molecule drugs include ACI-19764, a brain-penetrant NLRP3 inhibitor, which completed IND/CTA-enabling studies in Q3 2025 and initiated a First-In-Human study in February 2026 . The Morphomer Tau aggregation inhibitors program identified several lead compounds in 2025 with plans for IND/CTA-enabling activities in 2026 . The company also regained global rights to semorinemab and crenezumab in February 2025 following termination of agreements with Genentech .

In diagnostics, the company has a suite of imaging agents in clinical development. PI-2620 (LNTH-2620), a Tau-PET imaging agent developed in collaboration with Lantheus, is in a pivotal Phase 3 histopathology trial (ADvance) for AD . ACI-12589, the first clinically validated a-syn-PET tracer, is being evaluated for differential diagnostic and prognostic potential . ACI-15916, a next-generation a-syn PET tracer, initiated a Phase 1 trial in PD in Q1 2025 . ACI-19626, a first-in-class TDP-43 PET tracer, is being evaluated in a First-In-Human study in healthy volunteers and patients with TDP-43 proteinopathies .

For the fiscal year ended December 31, 2025, AC Immune SA reported a net loss attributable to owners of the Company of CHF 70.4 million . The company had accumulated losses of CHF 439.0 million as of December 31, 2025 . As of December 31, 2025, cash and cash equivalents totaled CHF 26.8 million, and short-term financial assets were CHF 64.6 million, resulting in a total liquidity position of CHF 91.4 million . The company's consolidated balance sheets contain a material In-Process Research and Development (IPR&D) asset of CHF 50.4 million .

The company's strategy involves selectively partnering product candidates for global development and commercialization to optimize long-term growth. This approach leverages partners' expertise and resources, provides non-dilutive partnership revenue, and de-risks and accelerates product development . Notable partnerships include agreements with Janssen for anti-Tau active immunotherapies, Lantheus for Tau-PET tracers, Lilly for Morphomer Tau small molecules, and Takeda for anti-Abeta active immunotherapies . In May 2024, AC Immune received an upfront payment of USD 100.0 million (CHF 92.3 million) from Takeda for the ACI-24.060 program . In September 2024, AC Immune received a milestone payment triggered by the rapid rate of prescreening in the Phase 2b ReTain trial for ACI-35.030/JNJ-2056 .

Business Outlook

Management believes that existing capital resources, assuming no other milestone payments, will be sufficient to meet projected operating requirements until the end of Q3 2027 . The company expects to require additional capital to develop and commercialize certain product candidates, particularly if commercialization is pursued independently after regulatory approval .

A major growth area for AC Immune is the advancement of its wholly-owned active immunotherapy, ACI-7104.056, targeting pathological a-syn for early Parkinson's disease. Interim analyses from the Phase 2 VacSYn study in H2 2025 showed that ACI-7104.056 induces strong anti-a-synuclein antibody levels, is well tolerated with no safety issues, and disease-related biomarker results (a-syn CSF levels and neurofilament light chain (NfL)) suggest potential stabilization of PD pathology . Plasma glial fibrillary acidic protein (GFAP) and dopamine transporter (DaT) SPECT imaging show trends toward disease modification, and total scores on Part III of the Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) are suggestive of a trend for disease stabilization . Based on these results, AC Immune aims to seek regulatory feedback on a clinical development plan to potentially accelerate towards registration, with final data from Part 1 of the VacSYn trial expected in mid-2026 .

Another significant growth area is the ACI-24.060 program, an anti-Abeta active immunotherapy for AD and AD in DS, which is the subject of an exclusive option and license agreement with Takeda Pharmaceuticals USA, Inc. Under this agreement, AC Immune received an upfront payment of USD 100.0 million (CHF 92.3 million) and is eligible to receive payments of up to approximately USD 2.1 billion (CHF 1.7 billion), including an option exercise fee in the low-to-mid nine-figure USD range and potential development, commercial, and sales-based milestone payments . Upon commercialization, AC Immune will be entitled to receive tiered mid-to-high teens percentages royalties on worldwide net sales . Dosing in the high-dose cohort for DS subjects in the ABATE study was initiated in February 2025, and study part 1b, which will be conducted in the UK and US, is anticipated to be initiated in H1 2026 .

The ACI-35.030/JNJ-2056 program, an anti-pTau active immunotherapy, is being assessed in subjects with preclinical AD in the Phase 2b ReTain study. This trial aims to randomize approximately 500 participants with confirmed early-stage Tau pathology, who will be treated over a four-year period, and will include interim biomarker analyses potentially allowing for acceleration towards a regulatory filing . JNJ-2056 was granted Fast Track designation by the FDA in July 2024 . In September 2024, AC Immune received a milestone payment triggered by the rapid rate of prescreening in the ReTain trial . However, Johnson & Johnson has temporarily paused enrollment in the Phase 2b ReTain trial to evaluate aspects of the trial, though enrolled participants will continue to be treated and followed .

In terms of operational outlook, the company expects its research and development expenses to continue to increase in connection with ongoing activities, particularly as it and/or its collaboration partners continue existing studies and initiate new studies for ACI-35.030, ACI-24.060, ACI-7104.056, and Morphomer Tau, and initiate preclinical and clinical development of other product candidates . The company relies on third-party Contract Manufacturing Organizations (CMOs) for the manufacture, testing, packaging, labeling, storage, and distribution of non-clinical and clinical supplies of its product candidates and plans to continue this for the foreseeable future . The company performs periodic quality audits of manufacturing facilities and CMOs to monitor compliance with regional laws, regulations, and cGMP standards .

Planned capital allocation includes financing liquidity needs through a combination of equity offerings, debt financings, grants, and license and development agreements . In Q3 2024, the company entered into a new Open Market Sale Agreement with Jefferies LLC, allowing for the sale of up to USD 80.0 million (CHF 64.0 million) worth of common shares from time to time . The company does not expect to pay dividends in the foreseeable future, as any earnings are intended to be reinvested in the business until an established revenue stream supports continuing dividends .

Structural headwinds and execution risks include the potential for delays in clinical studies due to patient enrollment challenges, the need to comply with new diversity action plans for Phase 3 trials as required by the Food and Drug Omnibus Reform Act of 2022 (FDORA), and the possibility of serious adverse side effects during development or after approval . The company operates in highly competitive and rapidly changing industries, facing competition from companies with substantially greater financial, technical, and human resources . Unfavorable global economic conditions, including rising interest rates and high inflation, could increase business costs and impact the ability to raise additional capital . Changes in U.S. trade policy, including tariffs, could also adversely affect the business .

Risk Factors

AC Immune faces significant risks including the heavy dependence on the success of its clinical and preclinical products, with low probabilities of success in the central nervous system (CNS) space, and the possibility that early study results may not predict future success . The company operates in highly competitive and rapidly changing industries, with competitors potentially developing and commercializing products more successfully or earlier . Economic, political, regulatory, and other risks associated with international operations, such as economic weakness, political instability, differing regulatory requirements, and changes in currency exchange rates, could harm future results . Specifically, the U.S. government's imposition of tariffs, including an initial 31% tariff on goods from Switzerland, subsequently increased to 39% by Executive Order on July 31, 2025, and then reduced to 15% retroactive to November 14, 2025, could materially and adversely affect the business, results of operations, or financial condition . Public health crises, such as the Covid-19 pandemic, may cause disruptions to preclinical and clinical trials and regulatory approvals . The company is subject to increasing legal and regulatory developments related to environmental, social, and governance (ESG) and climate change matters, which may impose costs or result in reputational harm . There is a risk that the company's significant in-process research and development (IPR&D) asset of CHF 50.4 million may become impaired or written off if associated R&D efforts are abandoned or curtailed . Furthermore, the company's ability to use tax loss carry-forwards in Switzerland, amounting to CHF 362.3 million as of December 31, 2025, may be limited as these losses expire 7 years after the year incurred, posing a high risk of partial or entire expiration due to limited income .

Management Priorities

Management emphasizes a strategic vision focused on leveraging proprietary discovery platforms, SupraAntigen and Morphomer, to advance Precision Medicine for neurodegenerative diseases. The company's business strategy is built on three corporate pillars: Active Immunotherapy, small molecule assets targeting intracellular pathologies, and generating business development opportunities to support these pillars. Management highlights the goal of revolutionizing the treatment paradigm by addressing co-pathologies and enabling tailored therapeutic regimens, ultimately aiming for disease prevention. The company has a strong track record of establishing value-driving collaboration agreements with leading pharmaceutical companies like Janssen, Takeda, Lilly, and Lantheus, which allows for leveraging partners' expertise and resources, monetizing investments, and de-risking and accelerating product development. Management explicitly states the belief that existing capital resources, assuming no other milestone payments, will be sufficient to meet projected operating requirements until the end of Q3 2027 .

View Source Annual Report on SEC.gov ↗

References

  1. [1] Item 4, Business overview
  2. [2] Item 3, Risk factors — We are a clinical stage biopharmaceutical company with a history of losses. We anticipate incurring losses for the foreseeable future. As such, if we fail to obtain additional funding via product revenues, license and collaboration agreements, equity offerings or other forms of financing, we may need to delay, reduce or eliminate certain of our product development programs.
  3. [3] Item 4, Business overview — Our strategic vision
  4. [4] Item 4, Business overview — Our strategic vision
  5. [5] Item 4, Business overview — The benefits of our clinically-validated, proprietary technology platforms
  6. [6] Item 4, Business overview — The benefits of our clinically-validated, proprietary technology platforms
  7. [7] Item 4, Business overview — Our clinical programs in detail: ACI-7104.056 – anti-a-syn active immunotherapy
  8. [8] Item 4, Business overview — Our clinical programs in detail: ACI-24.060 – anti-Abeta active immunotherapy
  9. [9] Item 4, Business overview — Our clinical programs in detail: ACI-35.030 – anti-pTau active immunotherapy
  10. [10] Item 4, Business overview — Small Molecule Drugs: ACI-19764
  11. [11] Item 4, Business overview — Morphomer Tau
  12. [12] Item 4, Business overview — Monoclonal Antibodies
  13. [13] Item 4, Business overview — Our diagnostic portfolio: PI-2620
  14. [14] Item 4, Business overview — Our diagnostic portfolio: A-syn diagnostics
  15. [15] Item 4, Business overview — Our diagnostic portfolio: A-syn diagnostics
  16. [16] Item 4, Business overview — Our diagnostic portfolio: TDP-43 imaging FIH study
  17. [17] Item 3, Risk factors — We are a clinical-stage company and have a history of operating losses. We anticipate that we will continue to incur losses for the foreseeable future.
  18. [18] Item 3, Risk factors — We are a clinical-stage company and have a history of operating losses. We anticipate that we will continue to incur losses for the foreseeable future.
  19. [19] Item 3, Risk factors — If we fail to obtain additional funding, we may delay, reduce or eliminate our product development programs or commercialization efforts.
  20. [20] Item 3, Risk factors — Our significant in-process research and development (IPR&D) asset may become impaired.
  21. [21] Item 4, Business overview — Continuing to optimize our long-term growth by selectively partnering product candidates for global development and commercialization
  22. [22] Item 4, Business overview — License agreements and collaborations
  23. [23] Item 4, Business overview — Our clinical programs in detail: ACI-24.060 for AD and for AD in DS
  24. [24] Item 4, Business overview — Our clinical programs in detail: ACI-35.030 (JNJ-64042056 also now referred to as JNJ-2056)
  25. [25] Item 3, Risk factors — If we fail to obtain additional funding, we may delay, reduce or eliminate our product development programs or commercialization efforts.
  26. [26] Item 3, Risk factors — If we fail to obtain additional funding, we may delay, reduce or eliminate our product development programs or commercialization efforts.
  27. [27] Item 4, Business overview — Our clinical programs in detail: ACI-7104.056 – anti-a-syn active immunotherapy
  28. [28] Item 4, Business overview — Our clinical programs in detail: ACI-7104.056 – anti-a-syn active immunotherapy
  29. [29] Item 4, Business overview — Our clinical programs in detail: ACI-7104.056 – anti-a-syn active immunotherapy
  30. [30] Item 4, Business overview — Our clinical programs in detail: ACI-24.060 for AD and for AD in DS
  31. [31] Item 4, Business overview — Our clinical programs in detail: ACI-24.060 for AD and for AD in DS
  32. [32] Item 4, Business overview — Our clinical programs in detail: ACI-24.060 for AD and for AD in DS
  33. [33] Item 4, Business overview — Our clinical programs in detail: ACI-35.030 – anti-pTau active immunotherapy
  34. [34] Item 4, Business overview — Our clinical programs in detail: ACI-35.030 – anti-pTau active immunotherapy
  35. [35] Item 4, Business overview — Our clinical programs in detail: ACI-35.030 (JNJ-64042056 also now referred to as JNJ-2056)
  36. [36] Item 4, Business overview — Our clinical programs in detail: ACI-35.030 (JNJ-64042056 also now referred to as JNJ-2056)
  37. [37] Item 3, Risk factors — If we fail to obtain additional funding, we may delay, reduce or eliminate our product development programs or commercialization efforts.
  38. [38] Item 4, Business overview — Manufacturing and supply
  39. [39] Item 4, Business overview — Compliance with governing rules and quality requirements
  40. [40] Item 3, Risk factors — Raising additional capital may cause dilution to our shareholders, restrict our operations or require us to relinquish rights to our intellectual property or future revenue streams.
  41. [41] Item 3, Risk factors — Raising additional capital may cause dilution to our shareholders, restrict our operations or require us to relinquish rights to our intellectual property or future revenue streams.
  42. [42] Item 3, Risk factors — We do not expect to pay dividends in the foreseeable future.
  43. [43] Item 3, Risk factors — We depend on enrollment of patients in our clinical studies for our product candidates. If we are unable to enroll patients in our clinical studies, our research and development efforts could be materially adversely affected.
  44. [44] Item 3, Risk factors — We operate in highly competitive and rapidly changing industries, which may result in others discovering, developing or commercializing competing products before or more successfully than we do.
  45. [45] Item 3, Risk factors — Unfavorable global economic conditions could adversely affect our business, financial condition or results of operations.
  46. [46] Item 3, Risk factors — Unfavorable global economic conditions could adversely affect our business, financial condition or results of operations.
  47. [47] Item 3, Risk factors — We depend heavily on the success of our clinical and, to a lesser extent, preclinical products.
  48. [48] Item 3, Risk factors — We operate in highly competitive and rapidly changing industries, which may result in others discovering, developing or commercializing competing products before or more successfully than we do.
  49. [49] Item 3, Risk factors — Our business is subject to economic, political, regulatory and other risks associated with international operations.
  50. [50] Item 3, Risk factors — Unfavorable global economic conditions could adversely affect our business, financial condition or results of operations.
  51. [51] Item 3, Risk factors — A public health crisis, such as the Covid-19 pandemic may impact our business, including preclinical and clinical trials and regulatory approvals.
  52. [52] Item 3, Risk factors — Our ability to effectively monitor and respond to the rapid and ongoing developments and expectations relating to environmental, social and governance (ESG) and climate change matters, including legal and regulatory developments and related social expectations and concerns, may impose costs on us or result in reputational or other harm to us that could have a material adverse effect on our business, financial condition and results of operations.
  53. [53] Item 3, Risk factors — Our significant in-process research and development (IPR&D) asset may become impaired.
  54. [54] Item 3, Risk factors — Our ability to use tax loss carry-forwards in Switzerland may be limited.
  55. [55] Item 3, Risk factors — If we fail to obtain additional funding, we may delay, reduce or eliminate our product development programs or commercialization efforts.

Analysis on 5/22/2026