AC Immune Initiates Phase 1 Clinical Trial of NLRP3 Inhibitor ACI-19764 is an orally available highly brain-penetrant small molecule NLRP3 inhibitorNLRP3 inhibitors are a major new class of compounds linked to a broad spectrum of inflammatory conditions including both metabolic and neurological diseasesACI-19764 is an important addition to AC Immune’s growing small molecule pipelinePhase 1 results in healthy volunteers are expected in H2 2026 Lausanne, Switzerland, February 24, 2026 -- AC Immune SA (NASDAQ ...

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Core Insights - AC Immune SA has released interim results from the Phase 2 VacSYn trial for its anti-alpha-synuclein immunotherapy ACI-7104.056, indicating potential disease modification in early Parkinson's disease [1][2] - The results show stabilization of disease-related biomarkers, suggesting a slowing of neuronal damage and progression of Parkinson's disease [2][3] Biomarker Results - Elevated levels of neurofilament light (NfL) are associated with neuronal damage; stabilization of NfL levels indicates a potential slowing of neurodegeneration [2] - Plasma glial fibrillary acidic protein (GFAP) and dopamine transporter (DaT) SPECT imaging trends also suggest disease modification [3] Antibody Response - ACI-7104.056 demonstrated a 100% responder rate in generating antibodies against the a-syn target antigen, with serum antibody titers over 500-fold higher than the placebo group at week 76 [3][4] - Antibody responses were boosted with each immunization, and average IgG antibody levels in cerebrospinal fluid (CSF) were also over 500-fold higher than in the placebo group [4] Clinical Measures - Clinical measures of motor symptoms indicate a trend toward stabilization in the active treatment group, with no meaningful progression in the MDS-UPDRS Part III score compared to an expected increase in the placebo group [5][6] - The difference in change from baseline scores between the active treatment and placebo groups was enhanced when stratified by levodopa (L-DOPA) ON/OFF state [6] Safety and Tolerability - Interim results from weeks 50 and 76 show that ACI-7104.056 is generally safe and well-tolerated [6] - Final data from Part 1 of the VacSYn trial are anticipated in mid-2026 [6] Market Reaction - Following the announcement, AC Immune's stock price increased by 12.43%, reaching $3.14 [6]

Summary of AC Immune Conference Call - December 11, 2025 Company Overview - **Company**: AC Immune (NasdaqGM: ACIU) - **Focus**: Development of active immunotherapies for neurodegenerative diseases, particularly targeting alpha-synuclein in Parkinson's disease and tau/amyloid-beta in Alzheimer's disease [4][27] Key Industry Insights - **Parkinson's Disease**: Second most common neurodegenerative disorder, fastest growing neurological disease, affecting approximately 1% of the population over 65 years [9] - **Market Need**: Significant unmet need for disease-modifying therapies in Parkinson's disease, with current treatments primarily symptomatic [28] Core Points from the Call 1. **Vaccine Phase Two Trial Results**: - Positive interim results from the phase two trial of ACI-7104, an anti-alpha-synuclein active immunotherapy for early Parkinson's disease patients [2][24] - The trial included 34 subjects aged 40-75 with early-stage Parkinson's disease [13] 2. **Safety and Tolerability**: - ACI-7104 demonstrated a favorable safety profile with no serious adverse events related to the study drug [24] - Common adverse events included injection site reactions (56%), headache (14%), and fatigue (12%) [15] 3. **Immunogenicity**: - ACI-7104 achieved a 100% responder rate, with significant increases in antibody titers observed after each immunization [16][24] - Antibodies generated were shown to cross the blood-brain barrier, indicating potential efficacy in targeting alpha-synuclein in the brain [17] 4. **Biomarker Analysis**: - Interim analysis showed stabilization of total alpha-synuclein levels in cerebrospinal fluid (CSF) in the treatment group, suggesting target engagement [25] - Neurofilament light chain (NFL) levels remained stable in the treatment group, indicating a potential slowing of neurodegeneration [20] - DaT-SPECT imaging indicated no progression in dopamine transporter levels in the treatment group, contrasting with expected declines in the placebo group [21][32] 5. **Clinical Measures**: - MDS-UPDRS Part III scores, which assess motor symptoms, showed minimal changes in the treatment group over 74 weeks, suggesting stabilization of motor function [23][30] 6. **Future Development Plans**: - AC Immune is considering an accelerated development pathway towards registration, potentially skipping part two of the trial [46] - Plans to include U.S. sites in future studies and explore the inclusion of tracer molecules in the next study [47] Additional Insights - **Market Potential**: Partner programs have generated over CHF 450 million in payments, with potential for an additional CHF 4 billion in milestone payments and royalties [5] - **Long-term Vision**: AC Immune aims to pioneer precision prevention strategies for neurodegenerative diseases, leveraging their active immunotherapy platform [27] Conclusion - The interim results from the ACI-7104 trial indicate promising safety, immunogenicity, and potential disease-modifying effects in early Parkinson's disease, positioning AC Immune favorably in the neurodegenerative disease market [26][50]

Company Overview - AC Immune is focused on precision prevention of neurodegenerative diseases, particularly Alzheimer's and Parkinson's [4] - The company has potential partnering milestones exceeding CHF 4.3 billion [4] - As of September 30, 2025, AC Immune's cash reserves were CHF 108.5 million [6], equivalent to approximately USD 136 million [4] - The company has 100.9 million shares outstanding [6] ACI-7104 Phase 2 Interim Results - The Phase 2 study of ACI-7104 included a total enrollment of 34 patients [24] - The most common adverse events (AEs) were injection site reactions (55.9%), headaches (14.7%), and fatigue (11.8%) [28] - ACI-7104 demonstrated a 100% responder rate for anti-PD012 antibody titers in serum [29] - ACI-7104 treatment showed a trend towards stabilization of disease progression, with the MDS-UPDRS Part III total score suggesting stabilization [67] Biomarker and Imaging Findings - ACI-7104 immunization stabilized total alpha-synuclein levels in cerebrospinal fluid (CSF), demonstrating target engagement [41] - Neurofilament light chain (NfL) levels in CSF remained stable in the ACI-7104 group, suggesting a potential slowing of neurodegeneration [43] - Dopamine transporter (DaT-SPECT) imaging suggested stabilization of Parkinson's disease pathology [50]

Core Insights - AC Immune SA announced positive interim results from the Phase 2 VacSYn trial for ACI-7104.056, an active immunotherapy targeting alpha-synuclein in early Parkinson's disease, indicating potential to slow disease progression [2][4][11] Interim Results - The VacSYn trial is a placebo-controlled, biomarker-based Phase 2 study involving 34 patients, with all participants treated for at least 12 months [5] - Interim results demonstrated that all target criteria for immunogenicity were met, with a 100% responder rate and a clear safety profile [6][10] - Antibody titers in serum were over 500-fold higher in the treatment group compared to placebo, indicating a robust immune response [7][8] Biomarker and Clinical Assessments - Disease-related biomarkers showed stabilization in the treatment group, including total CSF alpha-synuclein levels and neurofilament light chain (NfL) [12] - Clinical measures indicated a trend for stabilization of motor symptoms in the active treatment group, with no meaningful progression in MDS-UPDRS Part III scores [9][12] Expert Commentary - Dr. Andrea Pfeifer, CEO of AC Immune, emphasized the potential of ACI-7104.056 to transform Parkinson's disease treatment based on the interim data [4] - Dr. Werner Poewe highlighted the promising consistency of trends across multiple biomarkers and clinical assessments, suggesting beneficial effects on disease progression [4] Future Development Plans - Based on the interim results, AC Immune plans to seek regulatory feedback to accelerate the clinical development plan towards registration [11] - Final data from Part 1 of the VacSYn trial is expected in mid-2026 [11]

Core Insights - AC Immune SA announced positive interim results from the Phase 2 VacSYn trial for ACI-7104.056, an active immunotherapy targeting alpha-synuclein in early Parkinson's disease, indicating potential to slow disease progression [2][4][11] Interim Results - The VacSYn trial is a placebo-controlled, biomarker-based study involving 34 patients, with participants treated for at least 12 months [5] - Interim results demonstrated that all target criteria for immunogenicity were met, with a 100% responder rate for antibody production [6] - ACI-7104.056 showed a clear safety profile with no clinically relevant safety issues reported, and the most common adverse events were transient injection site reactions (56%), headaches (15%), and fatigue (12%) [10] Biomarker and Clinical Assessments - Disease-related biomarkers indicated stabilization of Parkinson's disease pathology, with total CSF alpha-synuclein levels stabilizing in the treatment group while decreasing in the placebo group [13] - Neurofilament light chain (NfL) levels remained stable in the treatment group, suggesting a potential slowing of neuronal damage, while increasing in the placebo group [13] - Clinical measures, including the Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part III scores, showed no meaningful progression in the treatment group compared to an expected increase in the placebo group [13] Expert Commentary - Dr. Andrea Pfeifer, CEO of AC Immune, emphasized the potential of ACI-7104.056 to transform Parkinson's disease treatment and indicated plans to discuss regulatory pathways for clinical development [4] - Dr. Werner Poewe highlighted the promising consistency of trends across multiple biomarkers and clinical assessments, supporting further development of the program [4] Future Plans - Based on the interim results, AC Immune aims to seek regulatory feedback to potentially accelerate the clinical development plan for ACI-7104.056 towards registration, with final data from Part 1 of the trial expected in mid-2026 [11]

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]