Summary of AC Immune Conference Call Company Overview - **Company**: AC Immune (NasdaqGM: ACIU) - **Focus**: Development of precision medicine for neurodegenerative diseases, particularly through active immunotherapy and small molecules [3][4] Key Points Pipeline and Financials - AC Immune has a focused pipeline with several phase two products and wholly owned assets [3] - The company has generated over $430 million from partnerships, with potential for an additional $4 billion in milestones and royalties [3] - Cash reserves are projected to last until Q3 2027, allowing for investment in precision medicine [3] Active Immunotherapy Programs - Lead programs ACI-35.030 and ACI-24 are partnered with Johnson & Johnson and Takeda, both receiving fast-track designation from the FDA [4] - ACI-7104, an active immunotherapy against alpha-synuclein, is in phase two development, with data expected by the end of the year [4][15] Precision Medicine Approach - The company emphasizes the importance of precision medicine in neurodegenerative diseases, particularly in Alzheimer’s, where there are approximately 100 million patients and 300 million at risk [5] - Active immunotherapies and small molecules target various proteins involved in neurodegenerative diseases, including tau and alpha-synuclein [6] Small Molecule Development - Small molecules derived from the Morphomer platform can penetrate the brain and target misfolded proteins, showing potential for preventing neurotoxicity [6][7] - The Tau morphomer (664) demonstrated over 50% reduction in Tau pathology in aggressive mouse models [9] - NLRP3 inhibitors are in development for CNS applications and show promise in treating diseases like Parkinson's and Alzheimer's [10][11] Upcoming Milestones - Data from the ABATE trial in phase two, partnered with Takeda, is expected in December [14] - Results on immunogenicity and pharmacodynamics for ACI-7104 are anticipated, with a focus on alpha-synuclein reduction in the brain [15][18] - The company plans to submit IND CTA for several small molecules by December, with clinical trials starting early next year [15] Market Position and Strategy - AC Immune positions itself as a leader in active immunotherapy, which is seen as a safer and more effective long-term treatment option compared to monoclonal antibodies [21] - The company aims to transition into phase three development based on encouraging data from ongoing trials [19][20] Collaboration and Future Directions - The small molecule Tau program is partnered with Eli Lilly, with decisions on clinical lead molecules expected soon [25] - The company is exploring both CNS and non-CNS applications for its NLRP3 inhibitors, with a focus on neuroinflammation and metabolic diseases [26][27] Additional Insights - The company is optimistic about the potential of its therapies to modify disease progression in Alzheimer’s and other neurodegenerative conditions [13][24] - There is a growing interest in the role of inflammation in neurodegenerative diseases, which AC Immune aims to address through its innovative therapies [26][27]

Core Insights - AC Immune SA will participate in the Jefferies Global Healthcare Conference in London from November 17-20, 2025, including a fireside chat and one-on-one investor meetings [1][2] Company Overview - AC Immune SA is a clinical-stage biopharmaceutical company focused on precision therapeutics for neurodegenerative diseases, including Alzheimer's and Parkinson's diseases [3] - The company utilizes two clinically validated technology platforms, SupraAntigen® and Morphomer®, to develop a diversified pipeline of therapeutic and diagnostic programs, with candidates in Phase 2 and Phase 3 development [3] - AC Immune has established strategic partnerships with leading global pharmaceutical companies, resulting in over $4.5 billion in potential milestone payments and royalties [3]

Core Insights - AC Immune reported a quarterly loss of $0.2 per share, which was better than the Zacks Consensus Estimate of a loss of $0.22, representing an earnings surprise of +9.09% [1] - The company posted revenues of $1.17 million for the quarter ended September 2025, missing the Zacks Consensus Estimate by 22.51%, and a significant decline from $29.45 million in the same quarter last year [2] - The stock has gained approximately 17.8% year-to-date, outperforming the S&P 500's gain of 16.5% [3] Earnings Outlook - The future performance of AC Immune's stock will largely depend on management's commentary during the earnings call and the company's earnings outlook [4] - The current consensus EPS estimate for the upcoming quarter is -$0.22 on revenues of $1.96 million, and for the current fiscal year, it is -$0.91 on revenues of $6.05 million [7] Industry Context - The Medical - Biomedical and Genetics industry, to which AC Immune belongs, is currently ranked in the top 39% of over 250 Zacks industries, indicating a favorable outlook compared to lower-ranked industries [8] - Empirical research suggests a strong correlation between near-term stock movements and trends in earnings estimate revisions, which can be tracked using tools like the Zacks Rank [5][6]

Core Insights - AC Immune SA reported its financial results for Q3 2025, highlighting a strategic focus on high-value assets and advancements in its pipeline for neurodegenerative diseases [2][3][5] Financial Performance - The company had cash resources of CHF 108.5 million as of September 30, 2025, which is expected to fund operations until the end of Q3 2027, excluding potential milestone payments [6][10] - R&D expenses for Q3 2025 were CHF 13.1 million, a decrease from CHF 14.5 million in Q3 2024, primarily due to lower spending on the ACI-24.060 ABATE study [9][10] - The company reported a net loss of CHF 15.9 million for Q3 2025, compared to a net income of CHF 5.5 million in Q3 2024, largely due to the recognition of a CHF 24.6 million milestone in Q3 2024 [10][16] Pipeline and Development - The company is advancing three Phase 2 active immunotherapy programs and small molecule programs targeting NLRP3, Tau, and alpha-synuclein [3][6][7] - Upcoming milestones include interim results from the VacSYn trial of ACI-7104.056 for Parkinson's disease and the ABATE Phase 2 trial for ACI-24.060 in Alzheimer's disease, both expected in Q4 2025 [8][9] Research and Publications - AC Immune published significant research findings in peer-reviewed journals, including clinical data on ACI-35.030 in eBioMedicine and preclinical data on PET tracers for TDP-43 pathology in Nature Communications [6][7] Corporate Strategy - Following a strategic review, the company has reduced its workforce by approximately 30% to sharpen its investment focus on key assets [7][10] - The appointment of Prof. Catherine Mummery as Chair of the Clinical Advisory Board is aimed at enhancing the company's expertise in dementia clinical trials [7]

Core Insights - AC Immune SA has appointed Prof. Catherine Mummery as Chairwoman of its Clinical Advisory Board, bringing extensive experience in dementia clinical trials and neurodegenerative diseases [2][5][6] Company Overview - AC Immune is a clinical-stage biopharmaceutical company focused on precision therapeutics for neurodegenerative diseases, including Alzheimer's and Parkinson's diseases [2][8] - The company utilizes two validated technology platforms, SupraAntigen® and Morphomer®, to develop a diverse pipeline of therapeutic and diagnostic programs [8][10] Leadership and Expertise - Prof. Mummery has led over 20 early-stage studies on disease-modifying agents in dementia and has been involved in significant clinical trials, including AC Immune's ACI-35.030 [4][5] - The Clinical Advisory Board (CAB) includes other notable experts in the field, enhancing the company's strategic clinical development and regulatory advice [6][8] Clinical Development Focus - The company is advancing its pipeline of active immunotherapies, with several candidates in Phase 2 development and novel therapeutics targeting intracellular mechanisms of neurodegenerative diseases [5][9] - Prof. Mummery expressed enthusiasm for leading the CAB as the company approaches critical milestones in clinical trials [5][9]

Core Insights - AC Immune SA has published preclinical data on its first-in-class TDP-43 PET tracer, ACI-19626, which shows potential for precision medicine in neurodegenerative diseases [2][4][6] Group 1: TDP-43 and Neurodegenerative Diseases - TDP-43 is a key component in the pathology of several neurodegenerative diseases, including ALS, FTD, LATE, and is also associated with Alzheimer's and Parkinson's diseases [3][6] - The shared clinical features of these diseases complicate differential diagnosis, highlighting the need for reliable biomarkers [3][6] Group 2: ACI-19626 PET Tracer Characteristics - ACI-19626 demonstrates high specificity and selectivity for pathological TDP-43 aggregates, with rapid brain uptake and fast washout, indicating its potential for effective imaging in living patients [4][7] - The tracer shows excellent selectivity for TDP-43 over common co-pathologies such as Abeta, Tau, and alpha-synuclein, with no off-target binding against a wide range of receptors and enzymes [7] Group 3: Clinical Development and Future Prospects - ACI-19626 has been advanced into a Phase 1 clinical study, with initial readout expected in Q4 2025, aiming to facilitate the detection of TDP-43 pathology in patients [6][8] - The CEO of AC Immune emphasized the potential of accurate PET imaging to improve diagnosis and enable earlier therapeutic interventions, which could significantly impact clinical trial design and patient stratification [5][6]

Core Insights - AC Immune SA has published preclinical data on its first-in-class TDP-43 PET tracer, ACI-19626, which shows potential for precision medicine in neurodegenerative diseases [2][5][6] - TDP-43 pathology is a significant factor in various neurodegenerative diseases, complicating diagnosis due to overlapping clinical features [3][6] - ACI-19626 demonstrates high specificity and selectivity for TDP-43 aggregates, with promising pharmacokinetic properties [4][7][8] Company Overview - AC Immune SA is a clinical-stage biopharmaceutical company focused on precision therapeutics for neurodegenerative diseases, including Alzheimer's and Parkinson's diseases [10] - The company utilizes two technology platforms, SupraAntigen® and Morphomer®, to develop a diversified pipeline of therapeutic and diagnostic programs [10] - AC Immune has established strategic partnerships with leading pharmaceutical companies, resulting in over $4.5 billion in potential milestone payments and royalties [10] Research and Development - The publication in Nature Communications details the characterization of ACI-19626, highlighting its potential to improve diagnosis and treatment of TDP-43 proteinopathies [5][6] - ACI-19626 has been advanced into Phase 1 clinical trials, with initial results expected in Q4 2025 [5][6][8] - The tracer shows excellent selectivity for TDP-43 over other common co-pathologies, indicating its potential as a diagnostic tool [7][8]

Core Insights - AC Immune SA announced the peer-reviewed publication of results from the Phase 1b/2a trial of ACI-35.030, an active immunotherapy targeting Tau, in eBioMedicine [2][3] - The trial demonstrated that ACI-35.030 generated a rapid and durable polyclonal response against pathological Tau without clinically relevant safety issues [2][4] Company Overview - AC Immune SA is a clinical-stage biopharmaceutical company focused on precision therapeutics for neurodegenerative diseases, including Alzheimer's disease [12] - The company utilizes its proprietary SupraAntigen® technology to develop its immunotherapies, which are designed to elicit strong immune responses against misfolded proteins [12][8] Trial Results - ACI-35.030 showed a rapid and potent polyclonal antibody response against pathological forms of Tau after the first dose, with 94% to 100% response rates maintained until week 74 in high-dose cohorts [4][5] - The trial included two formulations, ACI-35.030 and JACI-35.054, with ACI-35.030 requiring only one injection to induce anti-pTau IgG antibody titers in all participants [5][6] - ACI-35.030 is currently advancing in the Phase 2b ReTain trial, which aims to assess its potential to modify the disease in preclinical Alzheimer's disease [6][9] Future Developments - The ongoing Phase 2b ReTain trial will include approximately 500 participants and aims to evaluate the cognitive effects of ACI-35.030 over a maximum of four years [10][11] - The primary endpoint of the trial is to measure cognitive decline using the Preclinical AD Cognitive Composite 5 (PACC-5) score, while secondary endpoints will assess the impact on Tau pathology [11]

Core Insights - AC Immune SA is focusing its investments on key assets, particularly three clinical-stage active immunotherapy programs and promising small molecule programs targeting NLRP3 and Tau [2][5] - The company plans to reduce its workforce by approximately 30% to enhance operational efficiency and extend its cash runway to the end of Q3 2027 [2][9] - CEO Dr. Andrea Pfeifer highlighted the progress in product candidates aimed at treating neurodegenerative diseases and the importance of ongoing collaborations with major pharmaceutical companies [3][4] Financial and Operational Strategy - The strategic review has led to a sharper focus on late-stage clinical development, particularly for Alzheimer's and Parkinson's diseases [9] - As of June 30, 2025, AC Immune reported cash resources of CHF 127.1 million, which will support operations until the end of Q3 2027, excluding potential milestone payments from partnerships [9] - The company maintains its guidance on clinical timelines, with interim data from ACI-7104.056 and ACI-24.060 expected in H2 2025 and H1 2026, respectively [5] Workforce and Employee Support - A consultation process with employees has been initiated in accordance with Swiss employment law, with support measures including severance packages and assistance in job placement [6] - The full implementation of workforce changes is expected by the end of 2025, with cost reductions becoming effective early in 2026 [6] Company Overview - AC Immune is a clinical-stage biopharmaceutical company specializing in precision therapeutics for neurodegenerative diseases, with validated technology platforms, SupraAntigen® and Morphomer® [7] - The company has a diversified pipeline featuring therapeutic and diagnostic programs, with significant potential for milestone payments exceeding $4.5 billion from strategic partnerships [7]

Company Performance - AC Immune reported a quarterly loss of $0.25 per share, which was worse than the Zacks Consensus Estimate of a loss of $0.20, marking an earnings surprise of -25.00% [1] - The company posted revenues of $1.58 million for the quarter ended June 2025, missing the Zacks Consensus Estimate by 57.3%, compared to revenues of $0.76 million a year ago [2] - Over the last four quarters, AC Immune has surpassed consensus EPS estimates three times but has topped consensus revenue estimates only once [2] Stock Outlook - AC Immune shares have declined approximately 18.7% since the beginning of the year, contrasting with the S&P 500's gain of 7.6% [3] - The company's earnings outlook is crucial for investors, as it includes current consensus earnings expectations for upcoming quarters and any recent changes to these expectations [4] - The current consensus EPS estimate for the coming quarter is -$0.24 on revenues of $1.14 million, and for the current fiscal year, it is -$0.93 on revenues of $6.04 million [7] Industry Context - The Medical - Biomedical and Genetics industry, to which AC Immune belongs, is currently ranked in the bottom 43% of over 250 Zacks industries, indicating a challenging environment [8] - Empirical research suggests a strong correlation between near-term stock movements and trends in earnings estimate revisions, which can impact AC Immune's stock performance [5][6]