EX-99.3 4 aciu-20250430xex99d3.htm EX-99.3

Exhibit 99.3

Graphic

PRESS 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
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:

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.
oAntibody responses were rapidly induced against the target antigen after 2 immunizations and were further boosted by each subsequent immunization.


oTreatment 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.
oBased 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.
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: 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

    

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)