AC Immune(ACIU)

Search documents
Peer-reviewed results from Phase 1b/2a Trial of Anti-pTau Active Immunotherapy from AC Immune Published in eBioMedicine
Globenewswire· 2025-09-25 11:00
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]
AC Immune Sharpens Pipeline Focus with Operational Efficiencies Extending Cash Runway
Globenewswire· 2025-09-04 07:45
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]
AC Immune (ACIU) Reports Q2 Loss, Misses Revenue Estimates
ZACKS· 2025-08-05 13:16
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]
AC Immune(ACIU) - 2025 Q2 - Quarterly Report
2025-08-05 11:00
[Financial Statements](index=1&type=section&id=Financial%20Statements) [Condensed Consolidated Balance Sheets (Unaudited)](index=1&type=section&id=Condensed%20Consolidated%20Balance%20Sheets%20(Unaudited)) The balance sheet shows a decrease in total assets and shareholders' equity from December 31, 2024, to June 30, 2025, while total liabilities remained relatively stable | Metric | June 30, 2025 (CHF thousands) | December 31, 2024 (CHF thousands) | | :--------------------------- | :------------------------------ | :-------------------------------- | | Total assets | 190,224 | 230,913 | | Total shareholders' equity | 74,743 | 112,270 | | Total liabilities | 115,481 | 118,643 | [Condensed Consolidated Statements of Income/(Loss) (Unaudited)](index=2&type=section&id=Condensed%20Consolidated%20Statements%20of%20Income%2F(Loss)%20(Unaudited)) The company reported increased revenue for both the three and six months ended June 30, 2025, compared to the prior year, while operating losses slightly decreased and loss per share improved | Metric | For the Three Months Ended June 30, 2025 (CHF thousands) | For the Three Months Ended June 30, 2024 (CHF thousands) | For the Six Months Ended June 30, 2025 (CHF thousands) | For the Six Months Ended June 30, 2024 (CHF thousands) | | :-------------------------------- | :------------------------------------------------------- | :------------------------------------------------------- | :----------------------------------------------------- | :----------------------------------------------------- | | Total revenue | 1,306 | 687 | 2,296 | 687 | | Operating loss | (19,388) | (20,961) | (38,759) | (41,029) | | Loss for the period | (21,189) | (22,760) | (40,218) | (40,622) | | Basic and diluted loss per share | (0.21) | (0.23) | (0.40) | (0.41) | [Condensed Consolidated Statements of Comprehensive Income/(Loss) (Unaudited)](index=2&type=section&id=Condensed%20Consolidated%20Statements%20of%20Comprehensive%20Income%2F(Loss)%20(Unaudited)) The total comprehensive loss for the three and six months ended June 30, 2025, decreased compared to the prior year, primarily reflecting the change in net loss for the period and minor currency translation differences | Metric | For the Three Months Ended June 30, 2025 (CHF thousands) | For the Three Months Ended June 30, 2024 (CHF thousands) | For the Six Months Ended June 30, 2025 (CHF thousands) | For the Six Months Ended June 30, 2024 (CHF thousands) | | :-------------------------- | :------------------------------------------------------- | :------------------------------------------------------- | :----------------------------------------------------- | :----------------------------------------------------- | | Loss for the period | (21,189) | (22,760) | (40,218) | (40,622) | | Other comprehensive income | 4 | — | 9 | 16 | | Total comprehensive loss | (21,185) | (22,760) | (40,209) | (40,606) | [Condensed Consolidated Statements of Changes in Equity (Unaudited)](index=3&type=section&id=Condensed%20Consolidated%20Statements%20of%20Changes%20in%20Equity%20(Unaudited)) Total shareholders' equity decreased significantly from January 1, 2025, to June 30, 2025, mainly due to the loss for the period, partially offset by share-based payments and share issuances | Metric | As of January 1, 2025 (CHF thousands) | As of June 30, 2025 (CHF thousands) | | :---------------------- | :------------------------------------ | :---------------------------------- | | Total shareholders' equity | 112,270 | 74,743 | | Loss for the period | (40,218) | (40,218) | | Share-based payments | 2,679 | 2,679 | [Condensed Consolidated Statements of Cash Flows (Unaudited)](index=4&type=section&id=Condensed%20Consolidated%20Statements%20of%20Cash%20Flows%20(Unaudited)) The company experienced a significant shift from cash provided by operating activities in 2024 to cash used in operating activities in 2025, with investing activities turning positive due to net maturities of short-term financial assets, while financing activities continued to use cash | Metric | For the Six Months Ended June 30, 2025 (CHF thousands) | For the Six Months Ended June 30, 2024 (CHF thousands) | | :------------------------------------------ | :----------------------------------------------------- | :----------------------------------------------------- | | Net cash flows provided by/(used in) operating activities | (34,414) | 74,051 | | Net cash flows provided by/(used in) investing activities | 26,911 | (99,377) | | Net cash flows (used in) financing activities | (505) | (750) | | Net (decrease) in cash and cash equivalents | (8,008) | (26,076) | | Cash and cash equivalents at June 30 | 25,722 | 51,564 | [Notes to the Interim Condensed Consolidated Financial Statements (Unaudited)](index=5&type=section&id=Notes%20to%20the%20Interim%20Condensed%20Consolidated%20Financial%20Statements%20(Unaudited)) [1. Corporate information](index=5&type=section&id=1.%20Corporate%20information) AC Immune SA is a clinical-stage biopharmaceutical company focused on discovering, designing, and developing novel medicines and diagnostics for neurodegenerative diseases, utilizing its proprietary SupraAntigen and Morphomer platforms - AC Immune SA is a clinical-stage biopharmaceutical company focused on neurodegenerative diseases (NDD) such as Alzheimer's disease (AD) and Parkinson's disease (PD)[10](index=10&type=chunk) - The company leverages two proprietary technology platforms: **SupraAntigen** (conformation-specific biologics) and **Morphomer** (conformation-specific small molecules)[10](index=10&type=chunk) - The corporate strategy targets 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 changes to the Company's accounting policies](index=5&type=section&id=2.%20Basis%20of%20preparation%20and%20changes%20to%20the%20Company's%20accounting%20policies) These interim financial statements are prepared in accordance with IAS 34 under the historical cost convention, with Swiss Francs as the reporting currency, and management makes critical judgments and estimates in areas like revenue recognition and share-based compensation, while maintaining a going concern basis supported by its cash position and short-term financial assets - The Interim Condensed Consolidated Financial Statements are prepared in accordance with **International Accounting Standard 34 (IAS 34)**[12](index=12&type=chunk) - The 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 believes it will meet its obligations for at least 12 months from the filing date, with a cash position of **CHF 25.7 million** and short-term financial assets of **CHF 101.4 million** as of June 30, 2025, supporting a going-concern basis[20](index=20&type=chunk) [Statement of compliance](index=5&type=section&id=Statement%20of%20compliance) - Interim Condensed Consolidated Financial Statements are prepared in accordance with **International Accounting Standard 34 (IAS 34)**[12](index=12&type=chunk) [Basis of measurement](index=5&type=section&id=Basis%20of%20measurement) - The financial statements are prepared under the **historical cost convention**[13](index=13&type=chunk) [Functional and reporting currency](index=5&type=section&id=Functional%20and%20reporting%20currency) - The financial statements are presented in **Swiss Francs (CHF)**, which is AC Immune SA's functional and the Group's reporting currency. The subsidiary uses the US Dollar (USD) as its functional currency[14](index=14&type=chunk) [Critical judgments and accounting estimates](index=6&type=section&id=Critical%20judgments%20and%20accounting%20estimates) - Key areas requiring judgments, estimates, and assumptions include revenue recognition on Licensing and Collaboration Agreements (LCAs), clinical development accruals, net employee defined benefit liability, share-based compensation, right-of-use assets and lease liabilities, and the 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) - The fair value of the Company's financial assets and liabilities (receivables, short-term financial assets, cash, trade payables, lease liabilities) approximates their carrying values due to short-term maturity[17](index=17&type=chunk) [Accounting policies, new standards not yet effective, interpretations and amendments adopted by the Company](index=6&type=section&id=Accounting%20policies,%20new%20standards%20not%20yet%20effective,%20interpretations%20and%20amendments%20adopted%20by%20the%20Company) - The accounting policies are consistent with those in the 2024 annual consolidated financial statements[18](index=18&type=chunk) - **IFRS 18**, effective January 1, 2027, will change the structure of the statement of profit or loss and enhance disclosures; the Company is evaluating its impact[19](index=19&type=chunk) [Going concern](index=6&type=section&id=Going%20concern) - The Company expects to meet its obligations for at least 12 months, supported by **CHF 25.7 million** in cash and **CHF 101.4 million** in short-term financial assets as of June 30, 2025[20](index=20&type=chunk) - Financing has primarily come from public offerings, share issuances, contract revenues from LCAs, and grants[21](index=21&type=chunk) - Inherent risks include uncertainty of project success, ability to raise additional capital, and the need to establish patent protection, collaborations, and attract key personnel[21](index=21&type=chunk) [3. Contract revenues and other operating income](index=7&type=section&id=3.%20Contract%20revenues%20and%20other%20operating%20income) Contract revenue significantly increased for the three and six months ended June 30, 2025, primarily driven by the Takeda Pharmaceuticals agreement, which included an upfront payment and potential future milestones and royalties, with a portion of this revenue recognized and the remainder deferred related to unsatisfied performance obligations Contract Revenue (CHF thousands) | Period | 2025 | 2024 | | :-------------------------- | :--- | :--- | | Three Months Ended June 30, | 1,306 | 687 | | Six Months Ended June 30, | 2,296 | 687 | - In May 2024, the Company entered into a worldwide option and license agreement with **Takeda Pharmaceuticals** for active immunotherapies targeting Abeta, including ACI-24.060 for AD[25](index=25&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 and additional potential development, commercial, and sales-based milestones of up to approximately **USD 2.1 billion**[25](index=25&type=chunk) - As of June 30, 2025, the Company recorded **CHF 87.3 million** in deferred contract revenue related to unsatisfied performance obligations under the Takeda agreement[32](index=32&type=chunk) [3.1 Licensing and collaboration agreements](index=7&type=section&id=3.1%20Licensing%20and%20collaboration%20agreements) - The Takeda agreement includes a license option and development, CMC, and regulatory activities as distinct performance obligations[27](index=27&type=chunk) - The **USD 100.0 million** upfront payment was allocated based on relative stand-alone selling prices: **USD 87.4 million (CHF 80.7 million)** to the license option and **USD 12.6 million (CHF 11.6 million)** to development, CMC, and regulatory activities[30](index=30&type=chunk) - Revenue for the license option is deferred until exercise or expiration, while revenue for development, CMC, and regulatory activities is recognized over the estimated completion period using an input method[31](index=31&type=chunk) [4. Loss per share](index=9&type=section&id=4.%20Loss%20per%20share) The basic and diluted loss per share improved for both the three and six months ended June 30, 2025, compared to the prior year, reflecting a slightly lower net loss and an increase in the weighted-average number of shares outstanding Loss per Share (EPS) | Metric | For the Three Months Ended June 30, 2025 | For the Three Months Ended June 30, 2024 | For the Six Months Ended June 30, 2025 | For the Six Months Ended June 30, 2024 | | :-------------------------------------------------------------------------------- | :--------------------------------------- | :--------------------------------------- | :------------------------------------- | :------------------------------------- | | Net loss attributable to equity holders of the Company (CHF thousands) | (21,189) | (22,760) | (40,218) | (40,622) | | Weighted-average number of shares outstanding used to compute EPS basic and diluted | 100,631,371 | 99,549,910 | 100,519,884 | 99,467,690 | | Basic and diluted loss per share for the period attributable to equity holders | (0.21) | (0.23) | (0.40) | (0.41) | [5. Property, plant and equipment](index=9&type=section&id=5.%20Property,%20plant%20and%20equipment) The net book value of property, plant and equipment slightly decreased from December 31, 2024, to June 30, 2025, due to depreciation exceeding additions Property, Plant and Equipment Carrying Amount (CHF thousands) | Metric | December 31, 2024 | June 30, 2025 | | :------------- | :---------------- | :------------ | | Carrying amount | 2,651 | 2,490 | - Depreciation expense for the six months ended June 30, 2025, was **CHF 724 thousand**[35](index=35&type=chunk) [6. Right-of-use assets, long-term financial assets and lease liabilities](index=10&type=section&id=6.%20Right-of-use%20assets,%20long-term%20financial%20assets%20and%20lease%20liabilities) Right-of-use assets decreased due to depreciation, while lease liabilities and associated expenses increased for the six months ended June 30, 2025, and the company also holds long-term financial assets in the form of lease deposits Right-of-Use Assets Carrying Amount (CHF thousands) | Metric | December 31, 2024 | June 30, 2025 | | :------------- | :---------------- | :------------ | | Carrying amount | 5,437 | 4,926 | Lease-Related Expenses and Cash Outflows (CHF thousands) | Metric | For the Six Months Ended June 30, 2025 | For the Six Months Ended June 30, 2024 | | :------------------------------------ | :------------------------------------- | :------------------------------------- | | Depreciation of right-of-use assets | 511 | 337 | | Interest expense on lease liabilities | 92 | 59 | | Total cash outflow for leases | 965 | 762 | - Contractual undiscounted cash flows for lease obligations totaled **CHF 5,323 thousand** as of June 30, 2025[39](index=39&type=chunk) [7. Accrued expenses](index=11&type=section&id=7.%20Accrued%20expenses) Accrued expenses, primarily consisting of R&D costs, payroll, and other items, slightly decreased from December 31, 2024, to June 30, 2025 Accrued Expenses (CHF thousands) | Metric | June 30, 2025 | December 31, 2024 | | :--------------- | :------------ | :---------------- | | Accrued expenses | 11,476 | 12,098 | [8. Intangible assets](index=11&type=section&id=8.%20Intangible%20assets) The company holds an acquired IPR&D asset for Parkinson's disease, which remains at its carrying amount of CHF 50.4 million and is not yet amortized as it is not ready for use, with no impairment triggering events identified as of June 30, 2025 Intangible Assets (CHF thousands) | Metric | June 30, 2025 | December 31, 2024 | | :------------------ | :------------ | :---------------- | | Acquired IPR&D asset | 50,416 | 50,416 | - The **IPR&D asset** is a clinically-validated active vaccine candidate for Parkinson's disease, not yet ready for use, and therefore not amortized[41](index=41&type=chunk) - No triggering events for impairment of the IPR&D asset were identified as of June 30, 2025[41](index=41&type=chunk) [9. Prepaid expenses](index=11&type=section&id=9.%20Prepaid%20expenses) Prepaid expenses, including R&D costs, administrative costs, and employee social obligations, decreased from December 31, 2024, to June 30, 2025 Prepaid Expenses (CHF thousands) | Metric | June 30, 2025 | December 31, 2024 | | :--------------- | :------------ | :---------------- | | Prepaid expenses | 2,542 | 4,302 | [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) Both cash and cash equivalents and short-term financial assets decreased from December 31, 2024, to June 30, 2025, and net proceeds from the maturity of short-term financial assets also saw a significant reduction compared to the prior year Cash and Short-term Financial Assets (CHF thousands) | Metric | June 30, 2025 | December 31, 2024 | | :-------------------------- | :------------ | :---------------- | | Cash and cash equivalents | 25,722 | 36,275 | | Short-term financial assets | 101,413 | 129,214 | - Net proceeds from the maturity of short-term financial assets amounted to **CHF 27.8 million** for the six months ended June 30, 2025, a decrease from **CHF 99.0 million** in the prior comparable period[44](index=44&type=chunk) [11. Share capital and Treasury shares](index=12&type=section&id=11.%20Share%20capital%20and%20Treasury%20shares) The number of treasury shares remained consistent between December 31, 2024, and June 30, 2025 - The Company had **10,899,773 treasury shares** remaining as of June 30, 2025, and December 31, 2024[46](index=46&type=chunk) [12. Share-based compensation](index=12&type=section&id=12.%20Share-based%20compensation) The number of outstanding share options and non-vested restricted share awards increased from December 31, 2024, to June 30, 2025, while share-based compensation expense decreased for the six months ended June 30, 2025, compared to the prior year Share Options and Restricted Share Awards | Metric | As of June 30, 2025 | As of December 31, 2024 | | :-------------------------------- | :------------------ | :---------------------- | | Outstanding share options | 5,259,656 | 5,010,827 | | Non-vested restricted share awards | 1,549,046 | 822,740 | - Share-based compensation expense charged against the income statement was **CHF 2.7 million** for the six months ended June 30, 2025, down from **CHF 3.3 million** in the prior comparable period[51](index=51&type=chunk) [Share-based option awards](index=12&type=section&id=Share-based%20option%20awards) - The Company's **2016 Share Option and Incentive Plan (SOIP)** authorizes various equity-based grants[48](index=48&type=chunk) Share Option Activity | Metric | Outstanding at January 1, 2025 | Granted during the period | Exercised during the period | Outstanding at June 30, 2025 | | :----------------------- | :----------------------------- | :------------------------ | :-------------------------- | :--------------------------- | | Number of options | 5,010,827 | 369,231 | (15,000) | 5,259,656 | [Restricted share awards](index=13&type=section&id=Restricted%20share%20awards) Restricted Share Awards Activity | Metric | Non-vested at December 31, 2024 | Granted during the period | Exercised during the period | Vested during the period | Non-vested at June 30, 2025 | | :-------------------------------- | :------------------------------ | :------------------------ | :-------------------------- | :----------------------- | :-------------------------- | | Number of shares | 822,740 | 1,303,342 | (56,630) | (491,585) | 1,549,046 | - The expense charged against the income statement for restricted share awards was **CHF 1.1 million** for the three months ended June 30, 2025, and **CHF 2.7 million** for the six months ended June 30, 2025[51](index=51&type=chunk) [13. Finance result, net](index=14&type=section&id=13.%20Finance%20result,%20net) The company reported a net finance loss for both the three and six months ended June 30, 2025, primarily driven by unfavorable foreign currency exchange differences, predominantly against the US Dollar, partially offset by financial income from short-term investments Net Finance Result (CHF thousands) | Period | 2025 | 2024 | | :-------------------------- | :----- | :----- | | Three Months Ended June 30, | (1,801) | (1,799) | | Six Months Ended June 30, | (1,459) | 407 | - The net finance loss is primarily due to unfavorable foreign currency exchange differences related to movements in the CHF versus foreign currencies, predominantly the **US Dollar**[53](index=53&type=chunk)[54](index=54&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 events warrant disclosure or recognition - No subsequent events were identified that warrant disclosure or recognition in these Interim Condensed Consolidated Financial Statements[55](index=55&type=chunk)
AC Immune Reports Second Quarter 2025 Financial Results and Provides a Corporate Update
Globenewswire· 2025-08-05 11:00
Core Viewpoint - AC Immune SA is advancing its pipeline of precision therapeutics for neurodegenerative diseases, with significant progress in multiple clinical programs and a strong financial position to support ongoing development [2][3][4]. Financial Results - For Q2 2025, AC Immune reported contract revenues of CHF 1.3 million, an increase from CHF 0.7 million in the same period of 2024 [12]. - The company recorded a net loss of CHF 21.2 million for Q2 2025, compared to a net loss of CHF 22.8 million in Q2 2024 [12][20]. - Research and development expenses decreased to CHF 16.8 million from CHF 17.1 million year-over-year, while general and administrative expenses also saw a decline to CHF 3.9 million from CHF 4.6 million [12][20]. Pipeline Development - AC Immune has three active immunotherapies in Phase 2 clinical development, including ACI-7104.056, which has shown strong immunogenicity and a favorable safety profile in early Parkinson's disease [3][7]. - The ACI-24.060 program is expected to reach a 12-month treatment milestone in December 2025, with interim results anticipated in early 2026 [7][9]. - The company is also advancing its small molecule NLRP3 program, ACI-19764, which is currently in IND-enabling studies [7][9]. Cash Position - As of June 30, 2025, AC Immune had a cash balance of CHF 127.1 million (approximately USD 157.6 million), providing funding into Q1 2027, excluding potential milestone payments [4][12]. Upcoming Milestones - Interim results from the VacSYn trial of ACI-7104.056 are expected later in 2025, and the AD3 cohort in the ABATE trial of ACI-24.060 will reach 12 months of treatment by year-end 2025 [4][7]. - The company plans to file an IND for ACI-19764 within the year [4][9].
AC Immune (ACIU) Earnings Call Presentation
2025-06-25 12:20
Company Overview - AC Immune has a broad and diverse pipeline of 16 programs, including 1 in Phase 3 and 5 in Phase 2, focused on neurodegenerative diseases [4] - The company has potential milestones exceeding CHF 4.3 billion through multiple global partnerships [4] - As of March 31, 2024, AC Immune has cash reserves of CHF 104.8 million, plus $100 million upfront from Takeda, funding operations into 2027 [4, 7] - The company anticipates a 2024 annual cash burn of CHF 65 million – 75 million [17] Pipeline and Milestones - AC Immune's pipeline includes clinical stage programs targeting Alzheimer's disease (AD), Parkinson's disease (PD), and other a-synucleinopathies [12] - Key milestones in H2 2024 include initial 6-month amyloid plaque data from the ABATE Phase 1b/2 trial of ACI-24.060 in AD, interim safety and immunogenicity data from the Phase 2 VacSYn clinical trial of ACI-7104.056 in PD, and first patient in Phase 2b clinical trial (ReTain) of ACI-35.030 [21] - The company is developing TDP-43-PET tracer with Phase 1 initiation planned [21] Technology and Partnerships - AC Immune's SupraAntigen platform is designed to stimulate the patient's immune system to produce their own antibodies, offering potential advantages over passive immunotherapy [22] - The company entered into a deal with Takeda for ACI-24.060, including a $100 million upfront payment and potential payments up to approximately $2.1 billion [29] - ACI-35.030 induced anti-ePHF Ab responses in 100% of patients after the first injection [46] Financials - The company's total potential deal value exceeds CHF 4.75 billion, including upfront payments of CHF 255.2 million and milestones received of CHF 147.4 million [83]
AC Immune (ACIU) Reports Q1 Loss, Lags Revenue Estimates
ZACKS· 2025-04-30 13:15
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]
AC Immune(ACIU) - 2025 Q1 - Quarterly Report
2025-04-30 11:15
[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)
AC Immune Reports First Quarter 2025 Financial Results and Provides a Corporate Update
Globenewswire· 2025-04-30 11:00
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]
AC Immune Reports Further Positive Interim Results from Phase 2 Trial of ACI-7104.056 Active Immunotherapy in Early Parkinson's Disease
Newsfilter· 2025-04-02 10:00
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]