EX-99.3 4 aciu-20251104xex99d3.htm EX-99.3

Exhibit 99.3

Graphic

PRESS RELEASE

AC Immune Reports Third Quarter 2025 Financial Results and Provides a Corporate Update

Sharpened investment focus on high-value assets, including three Phase 2 active immunotherapy programs and small molecule programs targeting NLRP3, Tau and a-syn
Cash resources of CHF 108.5 million as of September 30, 2025, provide funding to the end of Q3 2027 excluding any income from potential milestones
Peer-reviewed papers covering groundbreaking results including clinical data on ACI-35.030 (JNJ-64042056) published in eBioMedicine and preclinical data on first-in-class PET tracers for imaging TDP-43 pathology published in Nature Communications
IND/CTA filing for small molecule NLRP3 inhibitor ACI-19764 and the start of IND-enabling studies for Morphomer-Tau aggregation inhibitor both expected by year-end

Lausanne, Switzerland, November 4, 2025 -- AC Immune SA (NASDAQ: ACIU), a clinical-stage biopharmaceutical company pioneering precision therapeutics for neurodegenerative diseases, today reported results for the quarter ended September 30, 2025, and provided a corporate update.

Dr. Andrea Pfeifer, CEO of AC Immune SA, commented:We have sharpened our investment focus on our most valuable assets following a strategic review. Our pipeline assets have the potential to transform treatment and enable prevention of neurodegenerative disease. Our active immunotherapies for precision prevention of neurodegenerative diseases continue to make strong progress through Phase 2 development in Alzheimer’s disease and Parkinson’s disease. These are complemented by novel small-molecule therapeutics targeting intracellular mechanisms of neurodegenerative diseases. Importantly, our recent pipeline prioritization has extended our cash runway to the end of Q3 2027, without including anticipated milestone payments from our existing collaborations or potential payments from new business development deals.

“We are now moving towards multiple value-inflection points. Further interim results from Part 1 of the VacSYn trial of ACI-7104.056, our wholly owned anti-alpha-synuclein active immunotherapy for Parkinson’s disease, are expected this quarter. Our two partnered active immunotherapy programs are continuing to progress according to plan. We also published data in The Lancet’s eBioMedicine on ACI-35.030 (JNJ-64042056) with the first clinical demonstration that our SupraAntigen® platform generates highly differentiated active immunotherapies compared with other approaches, even with the same peptide sequence. This technology also powers our ACI-24.060 anti-Abeta active immunotherapy program, for which additional results are expected in H1 next year.”


Q3 2025 and Subsequent Highlights:

Following a strategic review by executive management, the Company sharpened its focused investment on its most important assets.
oThese include its three clinical-stage active immunotherapy programs, two of which are in ongoing pharma collaborations, and its most promising small molecule programs targeting NLRP3, Tau and a-synuclein.
oAs a result, the Company has reduced its workforce by around 30% and extended its cash for operations to the end of Q3 2027.
AC Immune groundbreaking research results published in peer-reviewed journals including:
othe clinical results from the completed Phase 1b/2a trial of active immunotherapy ACI-35.030’s (JNJ-2056) partnered with Janssen Pharmaceuticals, Inc., a Johnson & Johnson company, in eBioMedicine.
opreclinical research demonstrating the in vivo activity of a vectorized (AAV9) anti-TDP-43 monoclonal antibody in a model of ALS/FTD, in Molecular Therapy.
ofirst-in-class positron emission tomography (PET) tracers for imaging TDP-43 pathology in the brain, including ACI-19626, that could enable a precision medicine approach to neurodegenerative diseases which are currently difficult to diagnose, in Nature Communications.
Appointed Prof. Catherine Mummery, a deeply experienced neurologist and expert in dementia clinical trials, as a member and Chair of its Clinical Advisory Board (CAB).


Anticipated 2025 Milestones

Program

Milestone

Expected in

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

Q4 2025

ACI-24.060
anti-Abeta active immunotherapy

ABATE Phase 2 trial reaches 12-month treatment timepoint in the AD3 cohort by year end (with interim results reported thereafter)

Q4 2025

ACI-19764
Small molecule NLRP3 inhibitor

IND/CTA filing

Q4 2025

Morphomer-Tau aggregation inhibitors

Lead declaration and initiation of IND-enabling studies

Q4 2025

Morphomer a-syn aggregation inhibitor

Lead declaration

Q4 2025

TDP-43-PET tracer

Initial Phase 1 readout in genetic frontotemporal dementia (FTD)

Q4 2025

ACI-15916
a-syn-PET tracer

Phase 1 readout in Parkinson’s disease (PD)

Q4 2025

Analysis of Financial Statements for the Quarter Ended September 30, 2025

Cash position: The Company had total cash resources of CHF 108.5 million (CHF 165.5 million as of December 31, 2024), composed of CHF 27.7 million in cash and cash equivalents and CHF 80.7 million in short-term financial assets. The Company’s cash balance is expected to provide sufficient capital resources to the end of Q3 2027, excluding potential milestone payments.
R&D expenditures: R&D expenses for the three months ended September 30, 2025, were CHF 13.1 million, compared with CHF 14.5 million for the comparable period in 2024. The decrease was primarily due to lower spend associated with the ACI-24.060 ABATE study during the period, as well as lower expenses incurred on ACI-7104.056. These reductions were offset by higher costs in our NLRP3 inhibitor program (ACI-19764).
G&A expenditures: G&A expenses in the period were CHF 3.6 million, compared with CHF 3.8 million for the comparable period in 2024.
Restructuring expenses: Expenses recognized as a result of the restructuring were CHF 0.5 million compared to nil for the comparable period in 2024. These expenses include CHF 2.1 million of termination benefits, offset by a CHF 1.8 million gain on curtailment in the defined benefit pension liability.


Financial result: The financial result, net was a CHF 0.3 million gain for the three months ended September 30, 2025, compared to a CHF 1.8 million loss for the comparable period in 2024. This change was primarily driven by increased stability in foreign currency exchange differences in CHF versus foreign currencies, predominantly the U.S. Dollar.
IFRS loss for the period: The Company reported a net loss after taxes of CHF 15.9 million for the three months ended September 30, 2025, compared with a net income of CHF 5.5 million for the comparable period in 2024. The change period over period derives primarily from the recognition of a CHF 24.6 million milestone in Q3 2024 under the collaboration with Janssen Pharmaceuticals, Inc.

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: gary.waanders@acimmune.com

International Media

Chris Maggos

Cohesion Bureau

Phone: +41 79 367 62 54

Email: chris.maggos@cohesionbureau.com


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

    

September 30, 

    

December 31, 

2025

2024

Assets

 

  

 

  

Non-current assets

 

  

 

  

Property, plant and equipment

 

2,208

 

2,651

Right-of-use assets

 

4,653

 

5,437

Intangible asset

 

50,416

 

50,416

Long-term financial assets

 

584

 

415

Total non-current assets

 

57,861

 

58,919

 

 

Current assets

 

 

Prepaid expenses

 

3,294

 

4,302

Accrued income

 

402

 

1,099

Other current receivables

 

1,582

 

1,104

Short-term financial assets

 

80,727

 

129,214

Cash and cash equivalents

 

27,741

 

36,275

Total current assets

 

113,746

 

171,994

Total assets

171,607

 

230,913

 

 

Shareholders' equity and liabilities

 

 

 

Shareholders’ equity

 

 

Share capital

 

2,240

 

2,226

Share premium

 

480,170

 

478,506

Treasury shares

 

(218)

 

(218)

Currency translation differences

 

3

 

(5)

Accumulated losses

(419,751)

 

(368,239)

Total shareholders’ equity

 

62,444

 

112,270

 

Non-current liabilities

 

Long-term deferred contract revenue

2,700

 

4,560

Long-term lease liabilities

3,616

 

4,401

Net employee defined benefit liabilities

4,561

 

8,844

Total non-current liabilities

10,877

 

17,805

 

Current liabilities

Trade and other payables

 

1,566

 

2,658

Accrued expenses

 

11,993

 

12,098

Short-term deferred contract revenue

 

83,682

 

85,056

Short-term lease liabilities

 

1,045

 

1,026

Total current liabilities

 

98,286

 

100,838

Total liabilities

 

109,163

 

118,643

Total shareholders’ equity and liabilities

 

171,607

 

230,913


Condensed Consolidated Statements of Income/(Loss) (Unaudited)

(In CHF thousands, except for per-share data)

For the Three Months

 

For the Nine Months

Ended September 30, 

 

Ended September 30, 

    

2025

    

2024

 

2025

    

2024

Revenue

 

  

 

  

  

 

  

Contract revenue

 

939

 

25,485

3,235

 

26,172

Total revenue

 

939

 

25,485

3,235

 

26,172

 

Operating expenses

 

Research & development expenses

 

(13,071)

 

(14,482)

(45,813)

 

(46,785)

General & administrative expenses

 

(3,567)

 

(3,753)

(11,900)

 

(13,275)

Other operating income/(expense), net

 

 

19

21

 

128

Restructuring expenses, net

(467)

 

(467)

 

Total operating expenses

 

(17,105)

 

(18,216)

(58,159)

 

(59,932)

Operating income/(loss)

 

(16,166)

 

7,269

(54,924)

 

(33,760)

Financial income

 

366

 

939

1,512

 

2,307

Financial expense

 

(46)

 

(33)

(149)

 

(103)

Exchange differences

 

(12)

 

(2,672)

(2,513)

 

(3,563)

Finance result, net

 

308

 

(1,766)

(1,150)

 

(1,359)

 

Income/(loss) before tax

 

(15,858)

 

5,503

(56,074)

 

(35,119)

Income tax expense

 

 

 

Income/(loss) for the period

 

(15,858)

 

5,503

(56,074)

 

(35,119)

Income/(loss) per share:

Basic income/(loss) per share for the period attributable to equity holders

(0.16)

0.06

(0.56)

(0.35)

Diluted income/(loss) for the period attributable to equity holders

(0.16)

0.05

(0.56)

(0.35)

Condensed Consolidated Statements of Comprehensive Income/(Loss) (Unaudited)

(In CHF thousands)

For the Three Months

 

For the Nine Months

Ended September 30, 

 

Ended September 30, 

    

2025

    

2024

 

2025

    

2024

Loss for the period

 

(15,858)

 

5,503

(56,074)

 

(35,119)

Items that will be reclassified to income or loss in subsequent periods (net of tax):

 

 

  

 

  

Currency translation differences

 

(1)

 

11

8

 

27

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)

2,740

11

2,749

27

Total comprehensive loss, net of tax

 

(13,118)

 

5,514

(53,325)

 

(35,092)