Core Viewpoint - AC Immune reported a quarterly loss of $0.21 per share, slightly better than the Zacks Consensus Estimate of a loss of $0.22, indicating a 4.55% earnings surprise [1] - The company has shown mixed performance in revenue, with $1.1 million reported for the quarter, missing the consensus estimate by 3.42% [2] Financial Performance - Over the last four quarters, AC Immune has surpassed consensus EPS estimates three times [2] - The company has experienced a significant decline in share price, losing about 37% since the beginning of the year, compared to a 5.5% decline in the S&P 500 [3] Future Outlook - The future performance of AC Immune's stock will largely depend on management's commentary during the earnings call and the earnings outlook [4][6] - Current consensus EPS estimate for the upcoming quarter is -$0.20 on revenues of $3.07 million, and for the current fiscal year, it is -$0.86 on revenues of $36.52 million [7] Industry Context - The Medical - Biomedical and Genetics industry, to which AC Immune belongs, is currently ranked in the top 32% of over 250 Zacks industries, indicating a favorable outlook compared to lower-ranked industries [8]

[Condensed Consolidated Balance Sheets (Unaudited)](index=1&type=section&id=Condensed%20Consolidated%20Balance%20Sheets%20%28Unaudited%29) Presents the company's financial position, showing a decrease in total assets and shareholders' equity as of March 31, 2025 Key Balance Sheet Items (Unaudited) | Item | As of March 31, 2025 (CHF thousands) | As of December 31, 2024 (CHF thousands) | Change (CHF thousands) | | :-------------------------------- | :------------------------------------- | :-------------------------------------- | :--------------------- | | Total assets | 211,082 | 230,913 | (19,831) | | Total shareholders' equity | 94,798 | 112,270 | (17,472) | | Total liabilities | 116,284 | 118,643 | (2,359) | | Cash and cash equivalents | 19,960 | 36,275 | (16,315) | | Short-term financial assets | 125,654 | 129,214 | (3,560) | | Total non-current assets | 58,948 | 58,919 | 29 | | Total current assets | 152,134 | 171,994 | (19,860) | [Condensed Consolidated Statements of Income/(Loss) (Unaudited)](index=2&type=section&id=Condensed%20Consolidated%20Statements%20of%20Income%2F%28Loss%29%20%28Unaudited%29) Details the company's financial performance, highlighting a significant increase in revenue and a slight improvement in operating loss for Q1 2025 Key Income Statement Items (Unaudited) | Item | For the Three Months Ended March 31, 2025 (CHF thousands) | For the Three Months Ended March 31, 2024 (CHF thousands) | Change (CHF thousands) | | :-------------------------------- | :---------------------------------------------------- | :---------------------------------------------------- | :--------------------- | | Total revenue | 990 | — | 990 | | Operating expenses | (20,360) | (20,068) | (292) | | Operating loss | (19,370) | (20,068) | 698 | | Finance result, net | 341 | 2,206 | (1,865) | | Loss before tax | (19,029) | (17,862) | (1,167) | | Loss for the period | (19,029) | (17,862) | (1,167) | - Total revenue increased significantly to **CHF 990 thousand** in Q1 2025 from no revenue in the prior comparable period[2](index=2&type=chunk) - Operating loss improved slightly to **CHF (19,370) thousand** in Q1 2025 compared to **CHF (20,068) thousand** in Q1 2024[2](index=2&type=chunk) [Condensed Consolidated Statements of Comprehensive Income/(Loss) (Unaudited)](index=2&type=section&id=Condensed%20Consolidated%20Statements%20of%20Comprehensive%20Income%2F%28Loss%29%20%28Unaudited%29) Reports the total comprehensive loss for the period, including other comprehensive income, for Q1 2025 and Q1 2024 Key Comprehensive Income Items (Unaudited) | Item | For the Three Months Ended March 31, 2025 (CHF thousands) | For the Three Months Ended March 31, 2024 (CHF thousands) | | :-------------------------------- | :---------------------------------------------------- | :---------------------------------------------------- | | Loss for the period | (19,029) | (17,862) | | Other comprehensive income/(loss) | 4 | 16 | | Total comprehensive loss, net of tax | (19,025) | (17,846) | [Condensed Consolidated Statements of Changes in Equity (Unaudited)](index=3&type=section&id=Condensed%20Consolidated%20Statements%20of%20Changes%20in%20Equity%20%28Unaudited%29) Outlines the changes in shareholders' equity, primarily reflecting the loss for the period, from January 1 to March 31, 2025 Key Changes in Equity (Unaudited) | Item | Balance as of January 1, 2025 (CHF thousands) | Loss for the period (CHF thousands) | Other comprehensive income (CHF thousands) | Share-based payments (CHF thousands) | Issuance of shares, net (CHF thousands) | Balance as of March 31, 2025 (CHF thousands) | | :-------------------------------- | :------------------------------------------ | :---------------------------------- | :----------------------------------------- | :----------------------------------- | :-------------------------------------- | :------------------------------------------- | | Share capital | 2,226 | — | — | — | 4 | 2,230 | | Share premium | 478,506 | — | — | — | 493 | 478,999 | | Treasury shares | (218) | — | — | — | — | (218) | | Accumulated losses | (368,239) | (19,029) | — | 1,558 | (502) | (386,212) | | Currency translation differences | (5) | — | 4 | — | — | (1) | | Total | 112,270 | (19,029) | 4 | 1,558 | (5) | 94,798 | - Total shareholders' equity decreased from **CHF 112,270 thousand** at January 1, 2025, to **CHF 94,798 thousand** at March 31, 2025, primarily due to the loss for the period[5](index=5&type=chunk) [Condensed Consolidated Statements of Cash Flows (Unaudited)](index=4&type=section&id=Condensed%20Consolidated%20Statements%20of%20Cash%20Flows%20%28Unaudited%29) Summarizes cash inflows and outflows from operating, investing, and financing activities for the three months ended March 31, 2025 Key Cash Flow Activities (Unaudited) | Activity | For the Three Months Ended March 31, 2025 (CHF thousands) | For the Three Months Ended March 31, 2024 (CHF thousands) | | :-------------------------------- | :---------------------------------------------------- | :---------------------------------------------------- | | Net cash flows provided by/(used in) operating activities | (18,816) | 1,024 | | Net cash flows provided by/(used in) investing activities | 3,028 | (23,561) | | Net cash flows (used in) financing activities | (258) | (688) | | Net (decrease) in cash and cash equivalents | (16,046) | (23,225) | | Cash and cash equivalents at March 31 | 19,960 | 57,009 | - Net cash flows from operating activities shifted from an inflow of **CHF 1,024 thousand** in Q1 2024 to an outflow of **CHF (18,816) thousand** in Q1 2025[7](index=7&type=chunk) - Net cash flows from investing activities significantly improved, moving from an outflow of **CHF (23,561) thousand** in Q1 2024 to an inflow of **CHF 3,028 thousand** in Q1 2025, primarily due to net maturities of short-term financial assets[7](index=7&type=chunk) [Notes to the Interim Condensed Consolidated Financial Statements (Unaudited)](index=5&type=section&id=Notes%20to%20the%20Interim%20Condensed%20Consolidated%20Financial%20Statements%20%28Unaudited%29) Provides detailed explanations and disclosures supporting the interim condensed consolidated financial statements [1. Corporate Information](index=5&type=section&id=1.%20Corporate%20information) AC Immune SA, founded in 2003, is a clinical-stage biopharmaceutical company focused on discovering and developing novel medicines and diagnostics for neurodegenerative diseases (NDD) like Alzheimer's and Parkinson's, leveraging its SupraAntigen and Morphomer technology platforms - AC Immune SA is a clinical-stage biopharmaceutical company developing novel medicines and diagnostics for neurodegenerative diseases (NDD) such as Alzheimer's disease (AD) and Parkinson's disease (PD)[10](index=10&type=chunk) - The company utilizes two proprietary technology platforms, SupraAntigen (conformation-specific biologics) and Morphomer (conformation-specific small molecules), to target misfolded proteins[10](index=10&type=chunk) - AC Immune's corporate strategy is founded upon a three-pillar approach targeting AD, focused non-AD NDD (including Parkinson's disease, ALS, and NeuroOrphan indications), and diagnostics[10](index=10&type=chunk) [2. Basis of Preparation and Accounting Policies](index=5&type=section&id=2.%20Basis%20of%20preparation%20and%20changes%20to%20the%20Company%27s%20accounting%20policies) The interim financial statements are prepared in accordance with IAS 34, using historical cost convention, and presented in Swiss Francs (CHF). Management makes critical judgments and estimates in areas like revenue recognition and share-based compensation. The company maintains a going concern basis, supported by its cash position and short-term financial assets, despite inherent risks in its clinical-stage business [Statement of Compliance](index=5&type=section&id=Statement%20of%20compliance) Confirms that the interim financial statements adhere to International Accounting Standard 34 (IAS 34) for interim financial reporting - These Interim Condensed Consolidated Financial Statements are prepared in accordance with International Accounting Standard 34 (IAS 34), Interim Financial Reporting[12](index=12&type=chunk) [Basis of Measurement](index=5&type=section&id=Basis%20of%20measurement) Explains that the financial statements are prepared primarily under the historical cost convention - The financial statements are prepared under the historical cost convention, except for items required to be accounted for at fair value[13](index=13&type=chunk) [Functional and Reporting Currency](index=5&type=section&id=Functional%20and%20reporting%20currency) Outlines the company's functional and reporting currency as Swiss Francs, with its U.S. subsidiary using the U.S. Dollar - The Interim Condensed Consolidated Financial Statements are presented in Swiss Francs (CHF), which is AC Immune SA's functional currency and the Group's reporting currency[14](index=14&type=chunk) - The Company's U.S. subsidiary has a functional currency of the U.S. Dollar (USD)[14](index=14&type=chunk) Exchange Rates (CHF/USD) | | For the Three Months Ended March 31, 2025 | For the Three Months Ended March 31, 2024 | Year Ended December 31, 2024 | | :--- | :--- | :--- | :--- | | Closing rate, USD 1 | 0.888 | 0.914 | 0.912 | | Weighted-average exchange rate, USD 1 | 0.908 | 0.883 | 0.889 | [Critical Judgments and Accounting Estimates](index=6&type=section&id=Critical%20judgments%20and%20accounting%20estimates) Discusses management's significant judgments and estimates in areas such as revenue recognition and share-based compensation - Management makes critical judgments and estimates in areas such as revenue recognition on Option, Licensing and Collaboration Agreements (OLCAs), clinical development accruals, net employee defined benefit liability, share-based compensation, right-of-use assets and lease liabilities, and IPR&D asset[16](index=16&type=chunk) [Fair Value of Financial Assets and Liabilities](index=6&type=section&id=Fair%20value%20of%20financial%20assets%20and%20liabilities) States that the fair value of the company's financial instruments approximates their carrying values due to short-term maturity - The fair value of the Company's financial instruments (receivables, short-term financial assets, cash and cash equivalents, trade payables, and lease liabilities) approximates their respective carrying values due to their short-term maturity[17](index=17&type=chunk) [Accounting Policies and New Standards Adopted](index=6&type=section&id=Accounting%20policies%2C%20new%20standards%2C%20interpretations%20and%20amendments%20adopted%20by%20the%20Company) Confirms consistency of accounting policies with prior annual statements and notes no relevant new IFRS standards effective January 1, 2025 - The accounting policies adopted are consistent with those followed in the preparation of the Company's annual consolidated financial statements for the year ended December 31, 2024[18](index=18&type=chunk) - There are no new IFRS standards, amendments, or interpretations mandatory as of January 1, 2025, that are relevant to the Company[18](index=18&type=chunk) [New Standards Not Yet Effective](index=6&type=section&id=New%20standards%20that%20are%20not%20yet%20effective) Identifies IFRS 18 as a new standard effective January 1, 2027, with potential impacts on financial statement presentation - IFRS 18 Presentation and Disclosure in Financial Statements, issued in April 2024 and effective January 1, 2027, will change the structure of the statement of profit or loss and enhance disclosure principles. The Company is currently evaluating its impact[19](index=19&type=chunk) [Going Concern](index=6&type=section&id=Going%20concern) Assesses the company's ability to meet obligations for the next 12 months, supported by its cash and short-term financial assets - The Company believes it will be able to meet all its obligations for at least 12 months from the filing date, supported by a cash position of **CHF 20.0 million** and short-term financial assets of **CHF 125.7 million** as of March 31, 2025[20](index=20&type=chunk) - The Company's success depends on its ability to establish and maintain a strong patent position, enter into collaborations, successfully move product candidates through clinical development, attract and retain key personnel, and acquire capital[21](index=21&type=chunk)[22](index=22&type=chunk) [3. Contract Revenue and Other Operating Income](index=7&type=section&id=3.%20Contract%20revenue%20and%20other%20operating%20income) AC Immune generated CHF 1.0 million in contract revenue for Q1 2025, primarily from the Takeda agreement, a significant increase from no revenue in the prior comparable period. This revenue is recognized from development, CMC, and regulatory activities under the agreement, with a substantial portion of the upfront payment deferred [3.1 Option, Licensing and Collaboration Agreements](index=7&type=section&id=3.1%20Option%2C%20licensing%20and%20collaboration%20agreements) Details contract revenue recognition, primarily from the Takeda agreement, and the allocation of upfront payments Contract Revenues | In CHF thousands | For the Three Months Ended March 31, 2025 | For the Three Months Ended March 31, 2024 | | :--- | :--- | :--- | | Takeda | 990 | — | | Total contract revenues | 990 | — | - In May 2024, AC Immune entered a worldwide option and license agreement with Takeda Pharmaceuticals for active immunotherapies targeting Abeta, including ACI-24.060 for the treatment of AD[27](index=27&type=chunk) - Under the Takeda agreement, AC Immune received an upfront payment of **USD 100.0 million (CHF 92.3 million)** in May 2024 and is eligible for an option exercise fee in the low-to-mid nine-figure USD range and additional potential milestones up to approximately **USD 2.1 billion (CHF 1.9 billion)**[27](index=27&type=chunk) - The upfront payment of **CHF 92.3 million** was allocated, with **CHF 80.7 million** to the license option (deferred) and **CHF 11.6 million** to development, CMC, and regulatory activities (recognized over time)[32](index=32&type=chunk)[33](index=33&type=chunk) - For the three months ended March 31, 2025, the Company recorded **CHF 1.0 million** in contract revenue reflecting efforts under the Takeda agreement for development, CMC, and regulatory activities[34](index=34&type=chunk) - As of March 31, 2025, **CHF 88.6 million** in deferred contract revenue is related to unsatisfied performance obligations under the Takeda agreement[35](index=35&type=chunk) [4. Loss Per Share](index=8&type=section&id=4.%20Loss%20per%20share) The basic and diluted loss per share for Q1 2025 increased to CHF (0.19) from CHF (0.18) in Q1 2024, reflecting a higher net loss attributable to equity holders Loss Per Share (EPS) | In CHF thousands except for share and per share data | For the Three Months Ended March 31, 2025 | For the Three Months Ended March 31, 2024 | | :--- | :--- | :--- | | Net loss attributable to equity holders of the Company | (19,029) | (17,862) | | Weighted-average number of shares outstanding | 100,408,779 | 99,385,471 | | Basic and diluted loss per share | (0.19) | (0.18) | [5. Property, Plant and Equipment](index=9&type=section&id=5.%20Property%2C%20plant%20and%20equipment) The net book value of property, plant and equipment increased to CHF 2,761 thousand as of March 31, 2025, from CHF 2,651 thousand at December 31, 2024, primarily due to additions in lab equipment Property, Plant and Equipment Carrying Amount | In CHF thousands | December 31, 2024 | March 31, 2025 | | :--- | :--- | :--- | | Furniture | 75 | 65 | | IT equipment | 331 | 324 | | Lab equipment | 1,483 | 1,654 | | Leasehold improvements | 762 | 718 | | Assets under construction | — | — | | Total | 2,651 | 2,761 | - Additions to property, plant and equipment totaled **CHF 471 thousand** for the three months ended March 31, 2025, with lab equipment accounting for **CHF 392 thousand**[37](index=37&type=chunk) - Depreciation expense for the period was **CHF 361 thousand**[37](index=37&type=chunk) [6. Right-of-Use Assets, Long-Term Financial Assets and Lease Liabilities](index=9&type=section&id=6.%20Right-of-use%20assets%2C%20long-term%20financial%20assets%20and%20lease%20liabilities) Right-of-use assets decreased slightly to CHF 5,186 thousand as of March 31, 2025, due to depreciation, with no new additions. Total cash outflow for leases increased to CHF 477 thousand in Q1 2025 from CHF 391 thousand in Q1 2024 Right-of-Use Assets Carrying Amount | In CHF thousands | Balance as of December 31, 2024 | Balance as of March 31, 2025 | | :--- | :--- | :--- | | Buildings | 5,320 | 5,076 | | Office equipment | 91 | 85 | | IT equipment | 26 | 25 | | Total | 5,437 | 5,186 | - No additions were recognized for right-of-use of leased assets for the three months ended March 31, 2025[38](index=38&type=chunk) Impact of Leases on Financial Statements | In CHF thousands | For the Three Months Ended March 31, 2025 | For the Three Months Ended March 31, 2024 | | :--- | :--- | :--- | | Depreciation of right-of-use assets | 251 | 167 | | Interest expense on lease liabilities | 47 | 30 | | Expense for short-term leases and leases of low value | 177 | 193 | | Total expense | 475 | 390 | | Total cash outflow for leases | 477 | 391 | Contractual Undiscounted Cash Flows for Lease Obligations (As of March 31, 2025) | | In CHF thousands | | :--- | :--- | | Less than one year | 1,198 | | 1-3 years | 2,370 | | 3-5 years | 2,055 | | Total | 5,623 | - Long-term financial assets include deposits in escrow accounts for leases, totaling **CHF 0.6 million** as of March 31, 2025, up from **CHF 0.4 million** at December 31, 2024[41](index=41&type=chunk) [7. Accrued Expenses](index=10&type=section&id=7.%20Accrued%20expenses) Accrued expenses, comprising R&D costs, payroll, and other expenses, decreased to CHF 11.1 million as of March 31, 2025, from CHF 12.1 million at December 31, 2024 Accrued Expenses | In CHF thousands | As of March 31, 2025 | As of December 31, 2024 | | :--- | :--- | :--- | | Accrued expenses | 11,146 | 12,098 | | Total accrued expenses | 11,146 | 12,098 | - Accrued expenses consist of accrued R&D costs, accrued payroll expenses, and other accrued expenses[42](index=42&type=chunk) [8. Intangible Assets](index=10&type=section&id=8.%20Intangible%20assets) The Company's intangible asset, an acquired In-Process Research & Development (IPR&D) asset for Parkinson's disease, remains at a net book value of CHF 50,416 thousand as of March 31, 2025, and is not amortized as it is not yet ready for use. No impairment triggering events were identified - The intangible asset is an acquired IPR&D asset, a clinically-validated active vaccine candidate for the treatment of Parkinson's disease[43](index=43&type=chunk) - The IPR&D asset is not yet ready for use and is therefore not currently being amortized[43](index=43&type=chunk) Intangible Assets (Net Book Value) | In CHF thousands | As of March 31, 2025 | As of December 31, 2024 | | :--- | :--- | :--- | | Acquired IPR&D asset | 50,416 | 50,416 | | Total intangible assets | 50,416 | 50,416 | - No triggering events that could result in an impairment of the IPR&D asset were identified as of March 31, 2025[44](index=44&type=chunk) [9. Prepaid Expenses](index=12&type=section&id=9.%20Prepaid%20expenses) Prepaid expenses, including R&D costs, administrative costs, and employee social obligations, decreased to CHF 3.6 million as of March 31, 2025, from CHF 4.3 million at December 31, 2024 - Prepaid expenses totaled **CHF 3.6 million** as of March 31, 2025, down from **CHF 4.3 million** at December 31, 2024[45](index=45&type=chunk) - These expenses include prepaid R&D costs, administrative costs, and employee social obligations[45](index=45&type=chunk) [10. Cash and Cash Equivalents and Short-Term Financial Assets](index=12&type=section&id=10.%20Cash%20and%20cash%20equivalents%20and%20short-term%20financial%20assets) Cash and cash equivalents decreased to CHF 19.96 million as of March 31, 2025, from CHF 36.275 million at December 31, 2024. Short-term financial assets also saw a slight decrease Cash and Cash Equivalents and Short-Term Financial Assets | In CHF thousands | As of March 31, 2025 | As of December 31, 2024 | | :--- | :--- | :--- | | Cash and cash equivalents | 19,960 | 36,275 | | Short-term financial assets | 125,654 | 129,214 | - Net proceeds from the maturity of investments in short-term financial assets amounted to **CHF 3.6 million** for the three months ended March 31, 2025, compared to net investments of **CHF 23.3 million** in the prior comparable period[46](index=46&type=chunk) [11. Treasury Shares](index=12&type=section&id=11.%20Treasury%20shares) The Company held 10,899,773 treasury shares as of March 31, 2025, consistent with the number held at December 31, 2024 - As of March 31, 2025, and December 31, 2024, the Company had **10,899,773** treasury shares remaining[47](index=47&type=chunk) [12. Share-Based Compensation](index=12&type=section&id=12.%20Share-based%20compensation) Share-based compensation expense decreased to CHF 1.6 million in Q1 2025 from CHF 1.9 million in Q1 2024. The number of outstanding share options increased, while non-vested restricted share awards also increased significantly [Share-Based Option Awards](index=12&type=section&id=Share-based%20option%20awards) Summarizes activity related to share option awards, including grants, forfeitures, and outstanding options - The Company grants equity-based instruments under its 2016 Share Option and Incentive Plan (SOIP)[49](index=49&type=chunk) Share Option Activity | | Outstanding at January 1, 2025 | Granted during the period | Forfeited during the period | Expired during the period | Outstanding at March 31, 2025 | | :--- | :--- | :--- | :--- | :--- | :--- | | Number of options | 5,010,827 | 369,231 | (50,987) | (1,908) | 5,327,163 | | Weighted-average exercise price (CHF) | 4.50 | 2.63 | 3.37 | 3.68 | 4.38 | - The weighted-average remaining term for outstanding options at March 31, 2025, was **6.5 years**[50](index=50&type=chunk) [Restricted Share Awards](index=13&type=section&id=Restricted%20share%20awards) Presents the activity and status of non-vested restricted share awards, including grants and vested shares Restricted Share Awards Activity | | Non-vested at December 31, 2024 | Granted during the period | Forfeited during the period | Exercised during the period | Vested during the period | Non-vested at March 31, 2025 | | :--- | :--- | :--- | :--- | :--- | :--- | :--- | | Number of shares | 822,740 | 1,295,331 | (32,518) | (40,269) | (212,039) | 1,875,994 | | Weighted-average grant date fair value (CHF) | 3.12 | 2.44 | 4.01 | 2.65 | 2.43 | 2.71 | - Share-based compensation expense charged against the income statement was **CHF 1.6 million** for the three months ended March 31, 2025, compared to **CHF 1.9 million** for the prior comparable period[51](index=51&type=chunk) [13. Finance Result, Net](index=13&type=section&id=13.%20Finance%20result%2C%20net) Net financial gains significantly decreased to CHF 0.3 million in Q1 2025 from CHF 2.2 million in Q1 2024, primarily due to unfavorable foreign currency exchange differences, particularly related to the U.S. Dollar Finance Result, Net | In CHF thousands | For the Three Months Ended March 31, 2025 | For the Three Months Ended March 31, 2024 | | :--- | :--- | :--- | | Finance result, net | 341 | 2,206 | - The decrease in net financial gains is primarily related to unfavorable foreign currency exchange differences, predominantly due to movements in the CHF versus the U.S. Dollar, compared with the preceding year-end rate[52](index=52&type=chunk)[53](index=53&type=chunk) [14. Subsequent Events](index=14&type=section&id=14.%20Subsequent%20events) Management has evaluated subsequent events through the issuance date of these interim financial statements and determined that no other events warrant disclosure or recognition - Management has evaluated subsequent events after the balance sheet date through the issuance of these Interim Condensed Consolidated Financial Statements and determined that no other such events warrant disclosure or recognition[54](index=54&type=chunk)

Core Insights - AC Immune SA reported its financial results for Q1 2025, highlighting advancements in its clinical-stage immunotherapy portfolio for neurodegenerative diseases [2][4] - The company demonstrated strong immunogenicity and a favorable safety profile for its lead candidate ACI-7104.056 in early Parkinson's disease patients [3][5] - AC Immune is well-financed with cash resources of CHF 145.7 million, sufficient to support operations into Q1 2027 [5][10] Clinical Development - The interim Phase 2 data for ACI-7104.056 showed antibody responses that were over 20-fold higher than placebo after four immunizations [6] - The company anticipates further interim results from the Phase 2 VacSYn trial in Q2 2025, which may lead to the initiation of Part 2 of the trial in H2 2025 [7][6] - Presentations at the AD/PD™ 2025 conference showcased the company's leadership in active immunotherapy and promising early-stage assets [5][6] Financial Performance - For the three months ended March 31, 2025, AC Immune reported a net loss of CHF 19.0 million, compared to a net loss of CHF 17.9 million for the same period in 2024 [10][18] - Research and development expenses were CHF 15.9 million, slightly higher than CHF 15.2 million in Q1 2024, primarily due to ongoing clinical trial costs [10][18] - The company had total revenue of CHF 990,000 from contract revenue, marking a new revenue stream [10][18] Anticipated Milestones - Key milestones for 2025 include reaching the 12-month treatment timepoint for the ACI-24.060 trial in H2 2025 and further interim results from ACI-7104.056 in Q2 2025 [7] - The company plans to declare leads and initiate IND-enabling studies for several early-stage candidates in H2 2025 [7]

Core Insights - AC Immune SA announced further positive interim results from the Phase 2 VacSYn clinical trial for ACI-7104.056, an active immunotherapy for early Parkinson's disease, highlighting safety and immunogenicity data [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 disease [6] - The company utilizes two clinically validated technology platforms, SupraAntigen® and Morphomer®, to develop a diversified pipeline of therapeutic and diagnostic programs [6] Clinical Trial Details - The VacSYn trial is an adaptive, placebo-controlled, biomarker-based Phase 2 study involving over 30 patients, with a treatment ratio of 3:1 for ACI-7104.056 versus placebo [2][4] - No serious adverse events related to the study drug have been reported, with mild and transient injection site reactions and headaches being the most common adverse events [2][7] Immunogenicity Results - Interim results indicate that ACI-7104.056 induced a more than 20-fold increase in anti-alpha-synuclein antibodies compared to placebo after four immunizations [3][7] - The antibody response was effectively boosted with each additional immunization, supporting the potential for increased antibody titers [7] Future Plans - Based on further interim results expected later in 2025, AC Immune may initiate Part 2 of the VacSYn trial with up to 150 patients, focusing on the progression of motor and non-motor symptoms and identifying disease-specific biomarkers [4]

Core Insights - AC Immune SA announced positive interim results from the Phase 2 VacSYn clinical trial for ACI-7104.056, an active immunotherapy for early Parkinson's disease, highlighting its safety and immunogenicity [2][3][4] Company Overview - AC Immune SA is a clinical-stage biopharmaceutical company focused on precision therapeutics for neurodegenerative diseases, including Alzheimer's and Parkinson's disease [7] - The company utilizes two technology platforms, SupraAntigen® and Morphomer®, to develop a diversified pipeline of therapeutic and diagnostic programs [7] Clinical Trial Details - The VacSYn trial is a placebo-controlled, biomarker-based study involving over 30 patients, with a treatment ratio of 3:1 for ACI-7104.056 versus placebo [3][5] - No serious adverse events related to the study drug have been reported, with mild and transient injection site reactions and headaches being the most common adverse events [3][8] Immunogenicity Results - Interim results indicate that ACI-7104.056 induced a more than 20-fold increase in anti-alpha-synuclein antibodies compared to placebo after four immunizations [4][8] - The antibody response was effectively boosted with each additional immunization, supporting the potential for increased antibody titers [8] Future Plans - Based on further interim results expected later in 2025, AC Immune may initiate Part 2 of the VacSYn trial with up to 150 patients, focusing on the progression of motor and non-motor symptoms and identifying disease-specific biomarkers [5]

Core Insights - AC Immune SA is set to present its precision medicine pipeline at the International Conference on Alzheimer's and Parkinson's Diseases (AD/PD™ 2025) in Vienna, Austria, from April 1 to 5, 2025, focusing on active immunotherapies for neurodegenerative diseases [1][4] Group 1: Upcoming Presentations - The company will host an industry symposium on April 2, 2025, featuring key opinion leaders discussing advances in clinical development of active immunotherapies [2] - Presentations will cover topics such as disease modification in Parkinson's disease, targeting alpha-synuclein, and precision prevention strategies for Alzheimer's disease [2][3] - The symposium will include a Q&A session and a replay will be available on AC Immune's website [2] Group 2: Research and Development Highlights - AC Immune's pipeline includes Morphomer® small molecules targeting Tau for Alzheimer's disease treatment, with a presentation scheduled for April 5, 2025 [3] - The company is developing Morphomer-antibody drug conjugates, a new class of drugs for neurodegenerative diseases [3] - Research on therapeutic small molecules targeting alpha-synuclein aggregation will also be presented [3] Group 3: Company Overview - AC Immune is a clinical-stage biopharmaceutical company focused on precision prevention for neurodegenerative diseases, leveraging its two technology platforms, SupraAntigen® and Morphomer® [6] - The company has a diversified pipeline featuring candidates in Phase 2 and Phase 3 development, with significant strategic partnerships leading to over $4.5 billion in potential milestone payments and royalties [6]

Core Viewpoint - AC Immune (ACIU) has underperformed the industry, sector, and S&P 500 Index, with shares declining by 18.3% over the past month despite better-than-expected fourth-quarter results [1][4]. Company Overview - AC Immune is a clinical-stage biopharmaceutical company based in Switzerland, focusing on developing drugs for neurodegenerative diseases using its proprietary technology platforms, SupraAntigen and Morphomer [5]. Pipeline Development - The company is advancing multiple therapeutic and diagnostic programs targeting misfolded proteins associated with Alzheimer's disease (AD), Parkinson's disease (PD), and other neurodegenerative disorders [5]. - Key candidates include: - ACI-24.060, an anti-Abeta immunotherapy for AD, currently in phase Ib/II ABATE study [6]. - ACI-7104.056, targeting pathological a-syn, in phase II study (VacSYn) [7]. - ACI-35.030/JNJ-2056, evaluated in preclinical AD in phase IIb ReTain study [7]. - P2620, a Tau-PET imaging agent in late-stage clinical development for AD [8]. Collaborations and Funding - AC Immune has secured strategic collaborations with major pharmaceutical companies, including an exclusive agreement with Takeda for its active immunotherapies, receiving an upfront payment of $100 million and potential total payments of up to $2.1 billion [9][10]. - Collaboration with Janssen Pharmaceuticals has also led to milestone payments due to rapid prescreening in the ReTain trial [11]. Financial Position - As of December 31, 2024, AC Immune reported cash resources of CHF 165.5 million, expected to sustain operations through the first quarter of 2027, assuming no additional milestones are met [12]. Valuation Metrics - ACIU shares are currently trading at a price/sales ratio of 6.15x, which is above its historical mean of 5.30x and the industry average of 1.70x [13]. Earnings Estimates - The loss per share estimate for 2025 has increased to 49 cents over the past 30 days, indicating a downward revision trend [14][15]. Market Outlook - The market for neurodegenerative diseases is anticipated to grow significantly, with potential positive data readouts for key candidates expected to enhance investor sentiment [8][16].

Financial Position - Cash resources at the end of 2024 amounted to CHF 165.5 million, providing a runway into Q1 2027[11]. - The total value of collaboration agreements exceeds approximately CHF 4.75 billion, with upfront payments received to date totaling CHF 255.2 million[71]. - Outstanding potential milestone payments from partnerships exceed CHF 4.3 billion, indicating significant future revenue opportunities[72]. Research and Development - R&D expenditure for the year was CHF 62.6 million, reflecting the company's commitment to advancing its pipeline[11]. - The company is developing a suite of diagnostics targeting Tau, asyn, and TDP-43 to improve early detection of neurodegenerative diseases[40]. - The ongoing Phase 3 clinical trial of PI2620, a PET tracer for Tau, is expected to support regulatory approval[23]. - The company aims to accelerate the development of novel therapeutics in Alzheimer's disease (AD) and expand its focus on Parkinson's disease (PD) and non-AD neurodegenerative diseases[54]. - The clinical stage product candidates include ACI-35.030, an anti-pTau active immunotherapy partnered with Janssen, which is also on FDA Fast Track[66]. - The Phase 1 trial for ACI-19626, a TDP-43 imaging diagnostic, was initiated in January 2025, with interim readout expected in December 2025[68]. - The company has established a Quality Management System (QMS) to ensure compliance with quality standards throughout the product development lifecycle[175]. Strategic Partnerships - An exclusive option and license deal was struck with Takeda for the anti-amyloid beta immunotherapy ACI-24.060, enhancing strategic partnerships[13]. - AC Immune received an upfront payment of USD 100 million from Takeda and is eligible for up to approximately USD 2.1 billion in potential payments, including milestone payments[65]. - The collaboration with partners like Takeda and Janssen allows the company to leverage expertise while partially monetizing investments, thus derisking product development[71]. Clinical Trials and Results - The Phase 2 VacSYn trial for ACI-7104.056 showed strong antibody response and was well tolerated, with more results expected in H1 2025[17]. - ACI-24.060, an anti-Abeta active immunotherapy, is currently being tested in a Phase 1b/2 trial with amyloid plaque reduction assessed using Abeta-PET imaging[65]. - The ongoing Phase 2b study ReTain for ACI-35.030 will randomize approximately 500 participants over a four-year period, with interim biomarker analyses planned[68]. - The VacSYn trial for ACI7104.056 is progressing well, with over 30 patients randomized and high anti-asynuclein antibody levels observed[67]. Innovation and Technology - The company has over 480 patents granted, underscoring its innovative capabilities in the field[11]. - The Morphomer platform has a library of approximately 17,200 CNS-optimized compounds, enhancing the efficiency of drug development[86]. - The Morphomer platform targets pathological protein aggregates, potentially enhancing therapeutic efficacy even in established disease states[79]. Commitment to Sustainability - The company reported a 2% reduction in electricity consumption from 2023 to 2024, reflecting its commitment to sustainability[154]. - 71% of employees commute sustainably, supported by a mobility policy that includes a 30% subsidy for public transport[156]. - The production of hazardous waste from R&D labs was reduced by 10% from 2023 to 2024, showcasing effective waste management practices[158]. Governance and Compliance - The Board of Directors comprises seven members, with 86% being independent and 43% female representation[188]. - The company has established two permanent committees to ensure effective governance and compliance with regulations[186]. - The Board of Directors has oversight responsibility for enterprise risk management, including cybersecurity risks, with annual reports on current trends[181]. Workforce and Culture - The company employs over 170 individuals, with women representing 59% of the workforce and 43% in executive leadership roles[140][150]. - The company emphasizes a culture of continuous learning and improvement to drive performance excellence and adapt to changes effectively[174]. - The company has a commitment to quality, integrating continuous training for employees to stay updated with regulatory requirements and industry best practices[172].

Company Overview - The company is a clinical stage biopharmaceutical entity with no products approved for sale and anticipates incurring losses for the foreseeable future [55]. - The company has no history of commercializing biologics or pharmaceutical products, making it challenging to predict future success [111]. - The company has never generated any revenue from product sales and relies on upfront and milestone payments from collaboration agreements for liquidity [218]. Product Development and Clinical Trials - The company has invested significantly in the development of active immunotherapies and diagnostics, including ACI-35.030, ACI-24.060, and Tau-PET tracer PI-2620, all of which are currently in clinical development [58]. - The company currently generates no revenues from drug or diagnostic sales and does not expect to generate product revenues for several years, if ever [58]. - The success of the company's product candidates heavily relies on achieving clinical and regulatory milestones, which have low probabilities of success in the CNS space [49]. - Patient enrollment in clinical studies is critical; delays could increase costs and hinder product development [85]. - The company has conducted clinical studies outside the U.S., and there is no assurance that data from these studies will be accepted by regulatory authorities [55]. - The company has not yet demonstrated the ability to successfully complete large-scale clinical studies or obtain marketing approval for its product candidates, which may affect future viability [111]. - Regulatory approval is necessary for the commercialization of product candidates, and the company cannot guarantee success in obtaining such approvals [232]. Financial Condition and Funding - The company incurred a net loss of CHF 50.9 million for the year ended December 31, 2024, with accumulated losses totaling CHF 368.2 million as of the same date [215]. - Significant operating losses are expected to continue as the company advances research and development efforts for current and future product candidates [216]. - The company has financed its liquidity requirements primarily through public offerings, share issuances, and contract revenues from collaboration agreements [217]. - The company may require additional capital to develop and commercialize product candidates, with potential significant commercialization expenses depending on the chosen market [224]. - The company expects research and development expenses to continue to increase due to ongoing studies and new studies for product candidates, including ACI-35.030, ACI-24.060, and ACI-7104.056 [222]. - The company holds a significant in-process research and development (IPR&D) asset valued at CHF 50.4 million, which carries a risk of impairment if associated R&D efforts are abandoned [231]. Competition and Market Risks - The company faces intense competition from large biopharmaceutical firms and may not achieve market acceptance for its products even if regulatory approval is obtained [49]. - The company faces potential competition from generic versions of its products, which could lead to a material decline in sales [70]. - If the company's active immunotherapies and diagnostics receive approval, competitors may file ANDAs or 505(b)(2) NDAs for generic versions [71]. - Market acceptance of the company's products is uncertain, and failure to achieve it could adversely affect revenue generation [81]. - The company operates in a highly competitive industry, facing significant challenges from larger competitors with more resources [93]. Intellectual Property and Legal Risks - The company may not successfully secure or maintain patent protection, which could lead to rapid sales declines and potential write-offs of intangible assets [74]. - The company may face challenges regarding inventorship claims that could result in loss of valuable intellectual property rights [176]. - The company is dependent on third-party manufacturers, which poses risks of production delays and quality control issues [155]. - The company may face risks related to potential intellectual property infringement claims that could materially affect its ability to commercialize product candidates [198]. - The company’s ability to protect its intellectual property rights globally is limited, which may allow competitors to use its technologies in jurisdictions without adequate patent protection [204]. Strategic Alliances and Collaborations - The company may seek additional strategic alliances for its product candidates, and failure to realize benefits from these alliances could adversely affect its financial condition [49]. - The company has strategic partnerships with Eli Lilly, Janssen, Life Molecular Imaging, and Takeda, which are crucial for the development and commercialization of its product candidates [141]. - In April 2024, the termination of collaboration agreements with Genentech became effective, allowing the company to regain global rights to certain product candidates [142]. - The company may seek orphan-drug designation for certain product candidates, which could provide market exclusivity but does not guarantee it [118]. Regulatory and Compliance Risks - The company is subject to various risks, including potential delays in obtaining marketing approvals and the possibility of not obtaining approvals at all [65]. - The company faces risks related to compliance with FDA regulations and potential manufacturing defects, which could adversely affect its business and reputation [154]. - The company anticipates increasing regulatory burdens and costs associated with the use of artificial intelligence in its operations [213]. - Compliance with evolving data privacy laws, such as the GDPR, may incur additional costs and operational restrictions, impacting business practices [131]. Economic and Geopolitical Factors - Economic factors such as rising interest rates and high inflation could increase operational costs and affect the company's ability to raise capital [101]. - The ongoing geopolitical conflicts, including those between Russia and Ukraine, may disrupt the company's supply chain and impact clinical trials [100]. - The geopolitical landscape, including conflicts like Russia-Ukraine, may heighten cybersecurity risks for the company and its partners [128]. Technology and Cybersecurity Risks - Rapid technological changes in the industry could render the company's products obsolete, affecting financial performance [94]. - Cybersecurity risks are increasing, with potential vulnerabilities in the company's technology systems that could disrupt operations and affect development programs [123]. - Data privacy and security breaches pose significant risks, with potential exposure of sensitive information leading to financial and reputational harm [124].

Core Insights - AC Immune SA reported significant advancements in its pipeline for neurodegenerative diseases, including a landmark deal with Takeda worth up to $2.1 billion, which includes a $100 million upfront payment [3][5][6] - The company achieved encouraging clinical data from its active immunotherapy programs, particularly ACI-7104.056 and ACI-24.060, and received U.S. FDA Fast Track designation for ACI-35.030 [3][5][6] - Financial results showed an increase in contract revenues to CHF 27.3 million for 2024, up from CHF 14.8 million in 2023, and a cash position of CHF 165.5 million, providing funding into Q1 2027 [14][26] Financial Performance - Total cash resources increased to CHF 165.5 million as of December 31, 2024, compared to CHF 103.1 million in 2023, ensuring operational funding into Q1 2027 [14][26] - Contract revenues for 2024 were CHF 27.3 million, significantly higher than CHF 14.8 million in the previous year, driven by milestone payments from partnerships with Janssen and Takeda [14][26] - The company reported a net loss of CHF 50.9 million for 2024, an improvement from a net loss of CHF 54.2 million in 2023 [14][26] Pipeline and Clinical Developments - ACI-24.060's ABATE Phase 1b/2 trial showed positive interim safety and tolerability data, with further results expected in 2025 [5][6] - ACI-35.030 (JNJ-2056) received U.S. FDA Fast Track designation, and the second milestone payment of CHF 24.6 million was triggered by rapid prescreening rates in the ReTain trial [11][14] - ACI-7104.056 demonstrated positive interim results in the VacSYn Phase 2 trial for Parkinson's disease, with further results anticipated in H1 2025 [5][11] Strategic Partnerships - The exclusive option and license agreement with Takeda for ACI-24.060 includes potential milestone payments of up to approximately $2.1 billion and tiered royalties on sales upon commercialization [5][6] - The partnership with Janssen resulted in a CHF 24.6 million milestone payment, reflecting the rapid progress in the ReTain trial for ACI-35.030 [11][14] Research and Development - R&D expenditures increased to CHF 62.6 million in 2024, primarily due to heightened clinical activities in ongoing trials [14][26] - The company is advancing multiple early-stage assets, including small molecule candidates targeting NLRP3 and Tau, with lead candidates expected to be selected in 2025 [3][14] Future Outlook - The company anticipates significant milestones in 2025, including interim results from the ABATE trial and further developments in its small molecule programs [13][14] - Total cash expenditure for 2025 is expected to be in the range of CHF 75–85 million, reflecting ongoing investment in clinical development [16]