AC Immune Third Quarter 2026 Financial and Corporate Update
AC Immune Third Quarter 2026 Financial and Corporate Update
Positive clinical and regulatory progress achieved across wholly-owned pipeline
- ACI-7104 received FDA Fast Track designation, Investigational New Drug (IND) clearance, and reported positive Part 1 week-100 results from the Phase 2 VacSYn trial in Parkinson’s disease
- Positive interim safety and tolerability results from the Phase 1 trial of NLRP3 inhibitor ACI-19764 in healthy volunteers
- Lead candidate declared in Morphomer® small molecule program targeting intracellular alpha-synuclein (a-syn)
- Further clinical data anticipated before year-end for ACI-7104 and early in 2027 for ACI-19764
- Cash resources of
CHF 73.9 million as ofSeptember 30, 2026 , providing cash runway into Q1 2028
Lausanne,
Q3 2026 and Subsequent Highlights: Wholly-Owned Programs
ACI-7104: anti-a-syn active immunotherapy
- Positive safety and immunogenicity results reported through week-100 in Part 1 of VacSYn, the ongoing Phase 2 trial evaluating ACI-7104 in patients with early-stage Parkinson’s disease.
- Strong immunogenicity demonstrated, with 100% response rate after three immunizations, clear antibody penetration into the cerebrospinal fluid (CSF) and preliminary signals for target engagement.
- Exploratory correlation analyses identified trends for a potential association between immunogenicity (antibody levels) and disease activity measures.
- Data will be available before year-end on the characterization of ACI-7104-induced antibodies including their a-syn binding properties
- Discussions with FDA regarding future development path planned for early 2027.
- ACI-7104 also received FDA Fast Track designation and clearance of its Investigational New Drug (IND) application during the period.
Morphomer-a-syn small molecule program
- Lead candidate Morphomer® small-molecule drug targeting a-syn has been selected.
- In vitro results have confirmed its potent inhibition of a-syn aggregation. Early-stage results will be presented in due course at an upcoming scientific conference.
- Preclinical development has now been initiated to take the candidate forward.
ACI-19764: small molecule, brain-penetrant NLRP3 inhibitor program
- Results in healthy volunteers were reported from the Phase 1 clinical trial showing the compound was safe and well-tolerated across single and multiple ascending dose cohorts with confirmed CSF penetration.
- Based on pharmacokinetic data, the therapeutic dose is expected to be ≤10mg once daily.
- The development program continues in a Phase 1b trial evaluating ACI-19764’s anti-inflammatory activity in patients with cardiovascular disease risk (elevated hsCRP), with initial results expected early in 2027.
Corporate Governance
- Mr.
Tom Graney was elected to the Board of Directors at the Extraordinary General Meeting (EGM) held onOctober 2 nd and will join theAudit and Finance Committee . After several years of service, Dr.Carl June stepped down from the Board of Directors and we thank him sincerely for his contribution and wish him well for the future.
Anticipated near-term news
| Program | News | Expected in |
| ACI-7104 anti-a-syn active immunotherapy |
characterization of ACI-7104-induced antibodies including a-syn binding properties | H2 2026 |
| ACI-19764 NLRP3 inhibitor |
Results from Phase 1b trial in patient cohort with elevated hsCRP | H1 2027 |
Analysis of Financial Statements for the Quarter Ended
- Cash Position: The Company had total cash resources of
CHF 73.9 million (CHF 91.4 million as ofDecember 31, 2025 ), composed ofCHF 18.7 million in cash and cash equivalents andCHF 55.2 million in short-term financial assets. The Company’s cash resources are expected to provide sufficient capital to last into Q1 2028, excluding potential milestone payments. - Revenue: Total revenues for the three months ended
September 30, 2026 and 2025 wereCHF 3.2 million andCHF 0.9 million , respectively. The increase was due to the recognition of revenues under the Takeda arrangements, which include recognition of the additional consideration received for the AD4 Cohort in 2026.
- R&D expenditures: R&D expenses for the three months ended
September 30, 2026 , wereCHF 9.9 million , compared withCHF 13.1 million for the comparable period in 2025. The decrease was partly due to lower personnel and operational spend ofCHF 2.2 million and a decrease ofCHF 1.9 million in our discovery and preclinical programs following the restructuring in the prior year. These changes were offset by a net increase ofCHF 1.0 million in our clinical programs.
- G&A expenditures: G&A expenses were
CHF 3.5 million in the three-month period endedSeptember 30, 2026 , compared toCHF 3.6 million for same period in 2025, reflecting a small decrease in personnel related expenses offset by other operational costs.
- Financial result: The financial result was a gain of
CHF 1.1 million for the three-month period endedSeptember 30, 2026 , compared with a gain ofCHF 0.3 million for the comparable period in 2025. The change was primarily driven by more favorable exchange differences in the current quarter.
- IFRS loss for the period: The Company had a net loss of
CHF 8.8 million for the three-month period endedSeptember 30, 2026 , compared toCHF 15.9 million for the same period in 2025.
Ends
For further information, please contact:
| SVP, Investor Relations & Corporate Communications Phone: +41 21 345 91 91 Email: gary.waanders@acimmune.com |
|
| International Media Optimum Phone: +44 (0) 20 4566 8543 Email: acimmune@optimumcomms.com |
|
About AC Immune SA
AC Immune (NASDAQ: ACIU) is a clinical-stage biopharma company selectively targeting the key pathologic misfolded proteins and pathways that drive neurodegenerative diseases. Building on more than two decades of expertise in the field of misfolded proteins, AC Immune is advancing a diversified portfolio of disease-modifying active immunotherapies and small molecule approaches.
AC Immune’s wholly-owned pipeline includes its lead program, ACI-7104, in Phase 2 development for early Parkinson's disease (PD), a progressive neurodegenerative disease affecting c.10 million people worldwide with no approved disease-modifying therapies today. By targeting misfolded alpha-synuclein, a key driver of PD progression, ACI-7104 aims to slow, or halt, the spread of the disease throughout the brain before irreversible neurological damage occurs. The Company is also advancing ACI-19764, an NLRP3 inflammasome inhibitor in Phase 1, and a preclinical intracellular small molecule alpha-synuclein program.
AC Immune has built one of the most extensively validated neurodegenerative disease pipelines in biotech, including three active immunotherapies with FDA Fast Track designation, and programs being developed in collaboration with three of the world’s leading pharmaceutical companies. These collaborations provide external validation of the Company's science, targets and proprietary platforms while contributing substantial non-dilutive funding, more than $4.5 billion in potential milestone payments, and future royalty opportunities. By combining deep expertise in protein misfolding with differentiated technology platforms and clinically validated targets, AC Immune is advancing a new generation of disease-modifying therapies for neurodegenerative diseases, aiming to make a real difference for patients.
All trademarks used or mentioned in this release are protected by law. 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.
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 | ||||
| 2026 | 2025 | |||
| Assets | ||||
| Non-current assets | ||||
| Property, plant and equipment | 1,751 | 1,989 | ||
| Right-of-use assets | 3,850 | 4,540 | ||
| Intangible asset | 50,416 | 50,416 | ||
| Long-term financial assets | 585 | 584 | ||
| Total non-current assets | 56,602 | 57,529 | ||
| Current assets | ||||
| Prepaid expenses | 4,631 | 3,972 | ||
| Accrued income | 158 | 360 | ||
| Other current receivables | 3,905 | 978 | ||
| Short-term financial assets | 55,186 | 64,617 | ||
| Cash and cash equivalents | 18,726 | 26,795 | ||
| Total current assets | 82,606 | 96,722 | ||
| Total assets | 139,208 | 154,251 | ||
| Shareholders' equity and liabilities | ||||
| Shareholders’ equity | ||||
| Share capital | 2,268 | 2,253 | ||
| Share premium | 484,148 | 481,863 | ||
| (213) | (218) | |||
| Currency translation differences | (5) | 7 | ||
| Accumulated losses | (459,254) | (439,021) | ||
| Total shareholders’ equity | 26,944 | 44,884 | ||
| Non-current liabilities | ||||
| Long-term deferred income | 1,507 | — | ||
| Long-term deferred contract revenue | 732 | 2,339 | ||
| Long-term lease liabilities | 3,051 | 3,689 | ||
| Net employee defined benefit liabilities | 9,312 | 8,646 | ||
| Total non-current liabilities | 14,602 | 14,674 | ||
| Current liabilities | ||||
| Trade and other payables | 832 | 2,068 | ||
| Accrued expenses | 8,382 | 8,067 | ||
| Short-term deferred income | 1,292 | — | ||
| Short-term deferred contract revenue | 86,310 | 83,706 | ||
| Short-term lease liabilities | 846 | 852 | ||
| Total current liabilities | 97,662 | 94,693 | ||
| Total liabilities | 112,264 | 109,367 | ||
| Total shareholders’ equity and liabilities | 139,208 | 154,251 | ||
Condensed Consolidated Statements of Income/(Loss) (Unaudited)
(In CHF thousands, except for per-share data)
| For the Three Months | For the Nine Months | |||||||
| Ended |
Ended |
|||||||
| 2026 | 2025 | 2026 | 2025 | |||||
| Revenue | ||||||||
| Contract revenue | 3,244 | 939 | 19,476 | 3,235 | ||||
| Total revenue | 3,244 | 939 | 19,476 | 3,235 | ||||
| Operating expenses | ||||||||
| Research & development expenses | (9,853) | (13,071) | (32,074) | (45,813) | ||||
| General & administrative expenses | (3,522) | (3,567) | (11,236) | (11,900) | ||||
| Other operating income/(expense), net | 330 | — | 437 | 21 | ||||
| Restructuring expenses, net | — | (467) | — | (467) | ||||
| Total operating expenses | (13,045) | (17,105) | (42,873) | (58,159) | ||||
| Operating loss | (9,801) | (16,166) | (23,397) | (54,924) | ||||
| Financial income | 280 | 366 | 679 | 1,512 | ||||
| Financial expense | (59) | (46) | (185) | (149) | ||||
| Exchange differences | 830 | (12) | 1,225 | (2,513) | ||||
| Finance result, net | 1,051 | 308 | 1,719 | (1,150) | ||||
| Loss before tax | (8,750) | (15,858) | (21,678) | (56,074) | ||||
| Income tax expense | — | — | — | — | ||||
| Loss for the period | (8,750) | (15,858) | (21,678) | (56,074) | ||||
| Loss per share: | ||||||||
| Basic and diluted loss per share for the period attributable to equity holders | (0.13) | (0.16) | (0.21) | (0.56) | ||||
Condensed Consolidated Statements of Comprehensive Income/(Loss) (Unaudited)
(In CHF thousands)
| For the Three Months | For the Nine Months | |||||||
| Ended |
Ended |
|||||||
| 2026 | 2025 | 2026 | 2025 | |||||
| Loss for the period | (8,750) | (15,858) | (21,678) | (56,074) | ||||
| Items that will be reclassified to income or loss in subsequent periods (net of tax): | ||||||||
| Currency translation differences: | (14) | (1) | (12) | 8 | ||||
| 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) | — | 2,741 | — | 2,741 | ||||
| Other comprehensive income/(loss) | (14) | 2,740 | (12) | 2,749 | ||||
| Total comprehensive loss, net of tax | (8,764) | (13,118) | (21,690) | (53,325) | ||||
Attachment
Source: AC Immune SA