AC Immune reported Q1 2025 results, advancing its immunotherapy pipeline and maintaining strong financial resources through Q1 2027.
Quiver AI Summary
AC Immune SA announced its financial results for the first quarter of 2025, reporting cash resources of CHF 145.7 million, sufficient to fund operations into Q1 2027. The company is advancing its clinical portfolio, particularly the Phase 2 trial of its anti-alpha-synuclein active immunotherapy ACI-7104.056 for Parkinson's disease, which has shown positive immunogenicity and a favorable safety profile. Interim results for this trial and others are expected throughout 2025, including presentations at the upcoming International Conference on Alzheimer’s and Parkinson’s Disease. While research and development expenses increased slightly compared to the previous year, the company continues to make progress with partnered programs and aims to achieve several milestones later in the year, including potential advancements in both ongoing and new trials. AC Immune is focused on developing precision therapies for neurodegenerative diseases and maintains optimistic long-term prospects for its pipeline.
Potential Positives
- Positive interim results for ACI-7104.056 show strong immunogenicity and safety in early-stage Parkinson’s disease patients, indicating promising potential for the therapy.
- Financial resources of CHF 145.7 million provide funding into Q1 2027, suggesting stability and the ability to advance multiple clinical trials and programs.
- Participation in the AD/PD™ 2025 conference highlights AC Immune's leadership in active immunotherapy and showcases promising early-stage assets, bolstering investor and public interest.
- Ongoing advancements in the company’s pipeline, including multiple value-inflection points anticipated throughout 2025, signal proactive progress and future growth opportunities.
Potential Negatives
- Net loss for Q1 2025 of CHF 19.0 million represents a decline compared to the loss of CHF 17.9 million in the same period of 2024, indicating worsening financial performance.
- Total shareholders' equity decreased from CHF 112.3 million at the end of December 2024 to CHF 94.8 million by March 31, 2025, reflecting deteriorating financial health.
- R&D expenses increased to CHF 15.9 million from CHF 15.2 million year-over-year, which may raise concerns about cost management and efficiency in advancing their clinical programs.
FAQ
What were AC Immune's financial results for Q1 2025?
AC Immune reported a net loss of CHF 19.0 million for Q1 2025, compared to a loss of CHF 17.9 million in Q1 2024.
What is the focus of AC Immune's clinical immunotherapy portfolio?
AC Immune's portfolio focuses on precision prevention of neurodegenerative diseases, including Parkinson's disease and Alzheimer’s disease.
When will additional results for ACI-7104.056 be released?
Additional interim results for ACI-7104.056 will be reported in Q2 2025, including pharmacodynamics and biomarkers data.
How well is AC Immune funded for future operations?
As of March 31, 2025, AC Immune has cash resources of CHF 145.7 million, sufficient to fund operations into Q1 2027.
What major events are anticipated from AC Immune in 2025?
Major events in 2025 include Phase 2 trial milestones for ACI-24.060 and updates on the VacSYn trial for ACI-7104.056.
Disclaimer: This is an AI-generated summary of a press release distributed by GlobeNewswire. The model used to summarize this release may make mistakes. See the full release here.
$ACIU Hedge Fund Activity
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- BLACKROCK, INC. removed 461,789 shares (-17.3%) from their portfolio in Q4 2024, for an estimated $1,246,830
- NORTHERN TRUST CORP added 403,031 shares (+inf%) to their portfolio in Q4 2024, for an estimated $1,088,183
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- WELLS FARGO & COMPANY/MN removed 112,402 shares (-10.1%) from their portfolio in Q4 2024, for an estimated $303,485
- MORGAN STANLEY added 101,614 shares (+156.5%) to their portfolio in Q4 2024, for an estimated $274,357
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Full Release
AC Immune Reports First Quarter 2025 Financial Results and Provides a Corporate Update
- Continuing to advance clinical active immunotherapy portfolio for precision prevention of neurodegenerative diseases
- Positive immunogenicity and good safety in interim results for wholly owned anti-alpha-synuclein (a-syn) active immunotherapy ACI-7104.056 in Phase 2 trial in Parkinson’s disease (PD)
- Additional ACI-7104.056 Phase 2 interim results (pharmacodynamics and biomarkers) expected in Q2 2025
- Presentations at International Conference on Alzheimer’s and Parkinson’s Disease (AD/PD™ 2025) highlight leadership in active immunotherapy and promising data on early-stage assets
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Cash resources of CHF 145.7 million as of March 31, 2025 provide funding into Q1 2027 before any potential milestones
Lausanne, Switzerland, April 30, 2025 -- AC Immune SA (NASDAQ: ACIU), a clinical-stage biopharmaceutical company pioneering precision therapeutics for neurodegenerative diseases, today reported results for the quarter ended March 31, 2025, and provided a corporate update.
Dr. Andrea Pfeifer, CEO of AC Immune SA, commented: “AC Immune’s portfolio of active immunotherapies for precision prevention of neurodegeneration continues to advance in clinical development. Our interim Phase 2 data on ACI-7104.056, our wholly owned a-syn active immunotherapy, demonstrated strong immunogenicity and a favorable safety profile in early Parkinson’s disease patients, further supporting its best-in-class characteristics. Our two partnered active immunotherapy programs, ACI-24.060 and ACI-35.030, also advanced well in their respective ongoing Phase 2 trials. Furthermore, we highlighted progress with our promising early-stage assets in presentations of preclinical data at AD/PD™ 2025, including Morphomer® small molecule drugs targeting a-syn and Tau, and Morphomer®-antibody drug conjugates (morADC) our new class of drug candidates for neurodegenerative diseases.”
“AC Immune is well financed into Q1 2027, without including significant potential milestones. We are moving towards several value-inflection points throughout 2025, including pharmacodynamic and biomarker data on ACI-7104.056 and potential initiation of Part 2 of the Phase 2 VacSYn trial, reaching the 12-month treatment timepoint for all the Alzheimer’s disease (AD) cohorts (including AD3 where enrollment was completed in December 2024) of the Phase 2 ABATE trial of ACI-24.060, and further developments across our early-stage pipeline.”
Q1 2025 and Subsequent Highlights:
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Additional interim safety and positive immunogenicity data from the Phase 2 VacSYn clinical trial evaluating ACI-7104.056, AC Immune’s wholly-owned anti-a-syn active immunotherapy candidate, for the treatment of patients with early PD.
- Antibody responses were rapidly induced against the target antigen after 2 immunizations and were further boosted by each subsequent immunization.
- Treatment with ACI-7104.056 induced an increase in anti-a-syn antibodies on average more than 20-fold higher than the placebo background level after four immunizations.
- Based on further interim results to be reported later in 2025, including pharmacodynamic and biomarker data, AC Immune may decide to initiate Part 2 of VacSYn, with the aim of establishing early proof-of-concept and identification of disease-specific biomarkers for rapid transition into a pivotal study.
- In vivo proof-of-concept study of proprietary morADC platform was completed in Q1.
- AC Immune’s therapeutic and diagnostic programs were featured in multiple presentations at AD/PD™ 2025 .
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AC Immune hosted an
industry symposium
highlighting the company’s industry-leading pipeline of active immunotherapies for precision prevention of neurodegenerative diseases.
Anticipated 2025 Milestones
Program | Milestone | Expected in |
ACI-24.060
anti-Abeta active immunotherapy |
ABATE Phase 2 trial reaches 12-month treatment timepoint in the AD3 cohort (with interim results reported shortly thereafter) | H2 2025 |
ACI-7104.056
anti-a-syn active immunotherapy |
Further interim results from Part 1 of Phase 2 VacSYn trial in PD, including pharmacodynamics and biomarkers | Q2 2025 |
Initiation of Part 2 of VacSYn trial | H2 2025 | |
ACI-19764
Small molecule NLRP3 inhibitor |
Lead declaration and initiation of IND-enabling studies | Q2 2025 |
IND/CTA filing | H2 2025 | |
TDP-43
monoclonal antibody |
Validated pharmacodynamic assay for clinical readout | H2 2025 |
Morphomer-Tau aggregation inhibitors | Lead declaration and initiation of IND-enabling studies | H2 2025 |
Morphomer a-syn aggregation inhibitor | Lead declaration | H2 2025 |
TDP-43-PET tracer | Initial Phase 1 readout in genetic frontotemporal dementia (FTD) | H2 2025 |
ACI-15916
a-syn-PET tracer |
Phase 1 readout in Parkinson’s disease (PD) | H2 2025 |
Analysis of Financial Statements for the Quarter Ended March 31, 2025
-
Cash position:
The Company had total cash resources of CHF 145.7 million (CHF 165.5 million as of December 31, 2024), composed of CHF 20.0 million in cash and cash equivalents and CHF 125.7 million in short-term financial assets. The Company’s cash balance provides sufficient capital resources into Q1 2027, without including potential milestones.
- R&D expenditures: R&D expenses in the period were CHF 15.9 million, compared with CHF 15.2 million for the comparable period in 2024. The expenses for the period were comprised mostly of ongoing clinical trial costs as well as personnel costs (including share-based payments), and regulatory, quality assurance, and intellectual property costs.
- G&A expenditures: G&A expenses in the period were CHF 4.4 million, compared with CHF 5.0 million for the comparable period in 2024.
- IFRS loss for the period: The Company reported a net loss after taxes of CHF 19.0 million for the three months ended March 31, 2025, compared with a net loss of CHF 17.9 million for the comparable period in 2024.
About AC Immune SA
AC Immune SA is a clinical-stage biopharmaceutical company and a global leader in precision prevention for neurodegenerative diseases, including Alzheimer’s disease, Parkinson’s disease, and NeuroOrphan indications driven by misfolded proteins. The Company’s two clinically validated technology platforms, SupraAntigen® and Morphomer®, fuel its broad and diversified pipeline of first- and best-in-class assets, which currently features a range of therapeutic and diagnostic programs, including candidates in Phase 2 and Phase 3 development. AC Immune has a strong track record of securing strategic partnerships with leading global pharmaceutical companies, resulting in substantial non-dilutive funding to advance its proprietary programs and >$4.5 billion in potential milestone payments plus royalties.
SupraAntigen® is a registered trademark of AC Immune SA in the following territories: AU, EU, CH, GB, JP, RU, SG and USA. Morphomer® is a registered trademark of AC Immune SA in CN, CH, EU, GB, JP, KR, NO, RU and SG.
The information on our website and any other websites referenced herein is expressly not incorporated by reference into, and does not constitute a part of, this press release.
For further information, please contact:
SVP, Investor Relations & Corporate Communications
Gary Waanders, Ph.D., MBA AC Immune Phone: +41 21 345 91 91 Email: [email protected] |
|
International Media
Chris Maggos Cohesion Bureau Phone: +41 79 367 6254 Email: [email protected] |
Forward looking statements
This press release contains statements that constitute “forward-looking statements” within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. Forward-looking statements are statements other than historical fact and may include statements that address future operating, financial or business performance or AC Immune’s strategies or expectations. In some cases, you can identify these statements by forward-looking words such as “may,” “might,” “will,” “should,” “expects,” “plans,” “anticipates,” “believes,” “estimates,” “predicts,” “projects,” “potential,” “outlook” or “continue,” and other comparable terminology. Forward-looking statements are based on management’s current expectations and beliefs and involve significant risks and uncertainties that could cause actual results, developments and business decisions to differ materially from those contemplated by these statements. These risks and uncertainties include those described under the captions “Item 3. Key Information – Risk Factors” and “Item 5. Operating and Financial Review and Prospects” in AC Immune’s Annual Report on Form 20-F and other filings with the Securities and Exchange Commission. Forward-looking statements speak only as of the date they are made, and AC Immune does not undertake any obligation to update them in light of new information, future developments or otherwise, except as may be required under applicable law. All forward-looking statements are qualified in their entirety by this cautionary statement.
Condensed Consolidated Balance Sheets (Unaudited)
(In CHF thousands)
As of | ||||
March 31, | December 31, | |||
2025 | 2024 | |||
Assets | ||||
Non-current assets | ||||
Property, plant and equipment | 2,761 | 2,651 | ||
Right-of-use assets | 5,186 | 5,437 | ||
Intangible asset | 50,416 | 50,416 | ||
Long-term financial assets | 585 | 415 | ||
Total non-current assets | 58,948 | 58,919 | ||
Current assets | ||||
Prepaid expenses | 3,607 | 4,302 | ||
Accrued income | 925 | 1,099 | ||
Other current receivables | 1,988 | 1,104 | ||
Short-term financial assets | 125,654 | 129,214 | ||
Cash and cash equivalents | 19,960 | 36,275 | ||
Total current assets | 152,134 | 171,994 | ||
Total assets | 211,082 | 230,913 | ||
Shareholders' equity and liabilities | ||||
Shareholders’ equity | ||||
Share capital | 2,230 | 2,226 | ||
Share premium | 478,999 | 478,506 | ||
Treasury shares | (218) | (218) | ||
Currency translation differences | (1) | (5) | ||
Accumulated losses | (386,212) | (368,239) | ||
Total shareholders’ equity | 94,798 | 112,270 | ||
Non-current liabilities | ||||
Long-term deferred contract revenue | 3,956 | 4,560 | ||
Long-term lease liabilities | 4,142 | 4,401 | ||
Net employee defined benefit liabilities | 8,940 | 8,844 | ||
Total non-current liabilities | 17,038 | 17,805 | ||
Current liabilities | ||||
Trade and other payables | 2,391 | 2,658 | ||
Accrued expenses | 11146 | 12098 | ||
Short-term deferred contract revenue | 84,676 | 85,056 | ||
Short-term lease liabilities | 1,033 | 1,026 | ||
Total current liabilities | 99,246 | 100,838 | ||
Total liabilities | 116,284 | 118,643 | ||
Total shareholders’ equity and liabilities | 211,082 | 230,913 |
Condensed Consolidated Statements of Income/(Loss) (Unaudited)
(
In CHF thousands, except for per-share data)
For the Three Months | ||||
Ended March 31, | ||||
2025 | 2024 | |||
Revenue | ||||
Contract revenue | 990 | — | ||
Total revenue | 990 | — | ||
Operating expenses | ||||
Research & development expenses | (15,916) | (15,165) | ||
General & administrative expenses | (4,443) | (4,971) | ||
Other operating income/(expense), net | (1) | 68 | ||
Total operating expenses | (20,360) | (20,068) | ||
Operating loss | (19,370) | (20,068) | ||
Financial income | 687 | 629 | ||
Financial expense | (54) | (36) | ||
Exchange differences | (292) | 1,613 | ||
Finance result, net | 341 | 2,206 | ||
Loss before tax | (19,029) | (17,862) | ||
Income tax expense | — | — | ||
Loss for the period | (19,029) | (17,862) | ||
Loss per share: | (0.19) | (0.18) |
Condensed Consolidated Statements of Comprehensive Income/(Loss) (Unaudited)
(In CHF thousands)
For the Three Months | ||||
Ended March 31, | ||||
2025 | 2024 | |||
Loss for the period | (19,029) | (17,862) | ||
Items that will be reclassified to income or loss in subsequent periods (net of tax): | ||||
Currency translation differences: | 4 | 16 | ||
Items that will not to be reclassified to income or loss in subsequent periods (net of tax): | ||||
Remeasurement gains on defined-benefit plans (net of tax) | — | — | ||
Total comprehensive loss, net of tax | (19,025) | (17,846) |
Attachment