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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]

Financial Performance - Total revenue for Q3 2025 was CHF 939,000, a decrease of 96.3% compared to CHF 25,485,000 in Q3 2024[2] - Operating loss for Q3 2025 was CHF 16,166,000, compared to an operating income of CHF 7,269,000 in Q3 2024[2] - Net loss for the nine months ended September 30, 2025, was CHF 56,074,000, compared to a net loss of CHF 35,119,000 for the same period in 2024[3] - Total comprehensive loss for the nine months ended September 30, 2025, was CHF 53,325,000, compared to a loss of CHF 35,092,000 for the same period in 2024[3] - For the three months ended September 30, 2025, the basic loss per share was CHF (0.16), compared to a profit of CHF 0.06 in the same period of 2024[35] - For the nine months ended September 30, 2025, the net loss attributable to equity holders was CHF (56,074) thousand, compared to a loss of CHF (35,119) thousand in 2024[35] Assets and Equity - Total assets decreased to CHF 171,607,000 as of September 30, 2025, from CHF 230,913,000 as of December 31, 2024, representing a decline of 25.6%[1] - Shareholders' equity fell to CHF 62,444,000 as of September 30, 2025, down from CHF 112,270,000 at the end of 2024, a decrease of 44.5%[1] - Cash and cash equivalents decreased to CHF 27,741,000 as of September 30, 2025, from CHF 36,275,000 at the end of 2024, a decline of 23.5%[1] - As of September 30, 2025, the company had cash and short-term financial assets totaling CHF 108.4 million, consisting of CHF 27.7 million in cash and CHF 80.7 million in short-term financial assets[20] - Short-term financial assets due in one year or less decreased to CHF 80,727 thousand as of September 30, 2025, compared to CHF 129,214 thousand at the end of 2024[44] Revenue and Contracts - For the three months ended September 30, 2025, AC Immune generated CHF 0.9 million in contract revenues, a significant decrease from CHF 25.5 million in the same period of 2024, representing a decline of approximately 96.5%[23] - For the nine months ended September 30, 2025, total contract revenues were CHF 3.2 million, down from CHF 26.2 million in the prior year, indicating a decrease of about 87.8%[23] - The company recorded CHF 86.4 million in deferred contract revenue related to unsatisfied performance obligations as of September 30, 2025[34] - AC Immune received an upfront payment of USD 100 million (CHF 92.3 million) from Takeda Pharmaceuticals in May 2024 as part of a licensing agreement for active immunotherapies targeting Abeta[26] - The potential total value of the agreement with Takeda could reach approximately USD 2.1 billion (CHF 1.7 billion) if all related milestones are achieved[26] Expenses and Costs - Research and development expenses for the nine months ended September 30, 2025, were CHF 45,813,000, slightly down from CHF 46,785,000 in the same period of 2024[2] - The company incurred restructuring costs during Q3 2025, primarily related to employee termination benefits, as part of cost-reduction initiatives[16] - The company incurred CHF 0.4 million in net restructuring expenses for the period ended September 30, 2025, which included CHF 2.1 million in termination benefits[54] - The total cash outflow for leases for the nine months ended September 30, 2025, was CHF 1,448 thousand, compared to CHF 1,150 thousand in the prior year[40] - The expense charged against the income statement for share-based compensation was CHF 0.8 million for the three months ended September 30, 2025, compared to CHF 1.2 million in 2024[51] Financial Position and Liabilities - The total accrued expenses as of September 30, 2025, were CHF 11,993 thousand, slightly down from CHF 12,098 thousand at the end of 2024[41] - The carrying amount of property, plant, and equipment as of September 30, 2025, was CHF 2,208 thousand, down from CHF 2,651 thousand at the end of 2024[36] - The acquired IPR&D asset for the treatment of Parkinson's disease has a carrying amount of CHF 50,416 thousand as of September 30, 2025, unchanged from December 31, 2024[42] Financial Gains and Losses - The company reported a finance result, net of CHF 308,000 for Q3 2025, compared to a loss of CHF 1,766,000 in Q3 2024[2] - For the three months ended September 30, 2025, AC Immune recorded CHF 0.3 million in net financial gains, compared to CHF 1.8 million in net financial losses for the same period in 2024[52] - For the nine months ended September 30, 2025, AC Immune reported net financial losses of CHF 1.2 million, an improvement from CHF 1.4 million in losses for the same period in 2024[53] Corporate Strategy and Risks - The company has established a three-pillar corporate strategy targeting Alzheimer's disease, non-Alzheimer's neurodegenerative diseases, and diagnostics[9] - The company is exposed to various risks, including uncertainties regarding the success of current projects and the ability to raise additional capital as needed[21] Other Information - The company is currently evaluating the impact of the new IFRS 18 standard on its financial statement presentation and disclosures, which will be effective from January 1, 2027[19] - Management evaluated subsequent events and determined there were no other events warranting disclosure or recognition in the financial statements[58] - The company recognized a CHF 1.8 million gain on curtailment related to the defined benefit liability for the three and nine months ended September 30, 2025, compared to nil in the corresponding periods for 2024[57] - The aggregate decrease in net employee defined benefit liabilities was CHF 4.3 million, resulting from the curtailment and remeasurement of the plan[57] - Other comprehensive income of CHF 2.7 million was recognized during the period due to the remeasurement of the defined benefit plan[57]