AC Immune Reports Full Year 2024 Financial Results and Provides a Corporate Update

AC Immune Reports Full Year 2024 Financial Results and Provides a Corporate Update

   -- Landmark exclusive option and license deal with Takeda for ACI-24.060 
      with $100 million upfront and additional potential milestones of up to 
      about $2.1 billion plus royalties on sales upon commercialization 
 
   -- ACI-24.060 ABATE Phase 1b/2 trial showed encouraging interim safety and 
      tolerability data in Down syndrome (DS) cohort; further interim results 
      in Alzheimer's disease (AD) and DS expected in 2025 
 
   -- Enrollment progress in JNJ-2056 (ACI-35.030) ReTain Phase 2b trial in 
      preclinical AD patients triggered second milestone payment of CHF 24.6 
      million; JNJ-2056 granted U.S. FDA Fast Track Designation in AD 
 
   -- ACI-7104.056 VacSYn Phase 2 trial demonstrated positive interim safety 
      and immunogenicity results in Parkinson's disease $(PD)$; further interim 
      results in H1 2025 
 
   -- Cash resources of CHF 165.5 million at year end provides funding into Q1 
      2027, assuming no other milestones 

Lausanne, Switzerland, March 13, 2025 -- AC Immune SA $(ACIU)$, a clinical-stage biopharmaceutical company pioneering precision therapeutics for neurodegenerative diseases, today reported results for the full year ended December 31, 2024, and provided a corporate update.

Dr. Andrea Pfeifer, CEO of AC Immune SA, commented: "We significantly advanced our leading position in the precision prevention of neurodegenerative diseases in 2024 through strong pipeline progress and the closing of a landmark deal with Takeda. Achievements across our portfolio of active immunotherapies, including encouraging clinical data from ACI-7104.056 and ACI-24.060 and U.S. FDA Fast Track designation for ACI-35.030, underscore the potential of this modality to treat patients earlier and to prevent or delay neurodegenerative diseases and their symptoms. We anticipate additional important evidence this year from the VacSYn trial of ACI-7104.056 and the ABATE trial of ACI-24.060, bringing us closer to redefining treatment with more convenient and better tolerated prevention options for these devastating conditions."

"The agreement with Takeda for ACI-24.060 includes potential milestone payments of up to $2.1 billion and affirms our proven track record of securing high-value partnerships. In 2024, our partnership with Takeda included a $100 million upfront payment, combined with a CHF 24.6 million milestone payment from Janssen, triggered by rapid prescreening rates in the ReTain trial of ACI-35.030. These payments ensure funding for currently planned operations into 2027 and reaffirm the value of our pipeline assets and differentiated discovery platforms."

"The ability to innovate is key to our future success. Driven by our two drug discovery platforms, in 2024, we advanced multiple early-stage assets, such as small molecule candidates targeting NLRP3 and Tau further into development."

2024 and Subsequent Highlights

Active Immunotherapy Programs

ACI-24.060 anti-Abeta active immunotherapy

   -- AC Immune and Takeda signed an exclusive option and license agreement for 
      AC Immune's active immunotherapies targeting Abeta, including ACI-24.060 
      for AD. AC Immune received an upfront payment of $100 million and is 
      eligible to receive total potential payments of up to approximately $2.1 
      billion; these include an option exercise fee, development, commercial 
      and sales milestones. Upon commercialization, AC Immune also is entitled 
      to receive tiered double-digit royalties on worldwide net sales. 
 
   -- Positive interim data from the ABATE Phase 1b/2 trial in individuals with 
      DS showed that ACI-24.060 was generally safe and well tolerated with no 
      serious adverse events related to the study drug and no cases of 
      amyloid-related imaging abnormalities $(ARIA)$. ABATE will now start to 
      evaluate the high dose of ACI-24.060 in individuals with DS. 
 
   -- Treatment of AD patients in the Phase 1b/2 ABATE trial continues. 

ACI-35.030 (JNJ-2056) anti-phospho-Tau (anti-pTau) active immunotherapy

   -- AC Immune received the second ReTain-related milestone payment of CHF 
      24.6 million under its agreement with Janssen Pharmaceuticals, Inc. 
      (Janssen), a Johnson & Johnson company. The payment was triggered by the 
      rapid prescreening rate in the potentially registrational Phase 2b ReTain 
      trial investigating JNJ-2056 (ACI-35.030) to treat preclinical 
      (pre-symptomatic) AD. Phase 1b/2a clinical testing showed that ACI-35.030 
      induces an antibody response targeting pathologic phosphorylated Tau 
      while sparing normal physiological forms of Tau. 
 
   -- Johnson & Johnson received Fast Track designation for JNJ-2056 from the 
      U.S. FDA for AD in July 2024. 
 
   -- The UK Medicines and Healthcare products Regulatory Agency (MHRA) has 
      awarded the innovative medicine designation, the Innovation Passport, for 
      ACI-35.030/JNJ-2056 in the treatment of AD. This is the entry point to 
      the Innovative Licensing and Access Pathway (ILAP) which aims to 
      accelerate time to market and facilitate patient access. 

ACI-7104.056 anti-a-syn active immunotherapy

   -- ACI-7104.056 demonstrated positive interim safety and immunogenicity in 
      the Phase 2 VacSYn clinical trial in early PD patients: 
 
          -- Positive antibody responses were induced against the target 
             antigen at week 6 after 2 immunizations and were strongly 
             boostable. 
 
          -- ACI-7104.056 induced an increase in anti-a-syn antibodies on 
             average 16-fold higher than the placebo background level after 
             three immunizations. 
 
          -- To date, no clinically relevant safety issues have been reported 
             and the most common adverse events were transient injection site 
             reactions (49%) and headaches (18%). 

Small Molecule Programs

   -- ACI-19764 small molecule NLRP3 inhibitor is undergoing in vivo proof of 
      concept with results expected in 2025 anticipated to enable 
      investigational new drug $(IND.AU)$ application. 
 
   -- Our Morphomer Tau and Morphomer a-syn small molecule aggregation 
      inhibitors have made steady progress with selection of lead candidates 
      expected in 2025. 

Diagnostic Programs

   -- AC Immune's partner Life Molecular Imaging (LMI) received FDA Fast Track 
      Designation for the Tau positron emission tomography $(PET.AU)$ diagnostic 
      PI-2620 in AD, progressive supranuclear palsy $(PSP)$, and corticobasal 
      degeneration $(CBD)$. 
 
   -- Phase 1 clinical trial of TDP-43-PET tracer ACI-19626 in genetic 
      frontotemporal dementia (FTD) is ongoing with initial clinical data 
      expected in 2025. 
 
   -- Completed IND-enabling studies of a-syn-PET tracer ACI-15916 for the 
      diagnosis of PD. 

Thought and Innovation Leadership

   -- AC Immune's therapeutic and diagnostic programs were featured in multiple 
      presentations at the International Conference on Alzheimer's & 
      Parkinson's disease (AD/PD$(TM)$ 2024). In addition, Andrea Pfeifer, Ph.D., 
      CEO of AC Immune, led an industry symposium exploring the latest clinical 
      advances in the diagnosis and treatment of alpha-synuclein pathologies. 
 
   -- AC Immune unveiled its novel therapeutic antibody drug conjugate 
      technology morADC for improved efficacy in neurodegenerative diseases at 
      the Alzheimer's Association International Conference $(AAIC)$ 2024. morADC 
      combines proprietary brain-penetrant small molecule Morphomers$(R)$ with 
      SupraAntigen(R) monoclonal antibodies and holds substantial promise in 
      our fight against neurodegeneration. 

Anticipated 2025 Milestones

 
Program        Milestone                                                    Expected 
                                                                             in 
ACI-24.060                                                                  H2 2025 
anti-Abeta      --    ABATE Phase 2 trial interim results in AD and DS 
active 
immunotherapy 
ACI-7104.056   --    Further interim results from Part 1 of Phase 2 VacSYn  H1 2025 
anti-a-syn           trial in PD, including pharmacodynamics and             H2 2025 
active               biomarkers 
immunotherapy  --    Initiation of Part 2 of VacSYn trial 
TDP-43                                                                      H2 2025 
monoclonal      --    Validated pharmacodynamic assay for clinical readout 
antibody 
ACI-19764                                                                   H1 2025 
Small           --    Lead declaration and initiation of IND-enabling        H2 2025 
molecule              studies 
NLRP3 
inhibitor       --    IND/CTA filing 
Morphomer-Tau                                                               H2 2025 
aggregation     --    Lead declaration and initiation of IND-enabling 
inhibitors            studies 
Morphomer                                                                   H2 2025 
a--syn          --    Lead declaration 
aggregation 
inhibitor 
morADC                                                                      H1 2025 
                --    In vivo PoC study of proprietary brain delivery 
                      platform 
TDP-43-PET                                                                  H2 2025 
tracer          --    Initial Phase 1 readout in genetic FTD 
ACI-15916                                                                   H2 2025 
a-syn-PET       --    Phase 1 readout 
tracer 
 

Analysis of Financial Statements for the Year Ended December 31, 2024

   -- Cash Position: The Company had total cash resources of CHF 165.5 million 
      as of December 31, 2024, compared to total cash resources of CHF 103.1 
      million as of December 31, 2023. The Company's cash balance provides 
      sufficient capital resources into Q1 2027, assuming no other milestones. 
 
   -- Contract Revenues: The Company recorded CHF 27.3 million in contract 
      revenues for the year ended December 31, 2024, compared with CHF 14.8 
      million in contract revenues in the prior year. For the year ended 
      December 31, 2024, our contract revenues of CHF 27.3 million were related 
      to: 
 
          -- The recognition of the second ReTain-related milestone payment of 
             CHF 24.6 million under the agreement with Janssen. The milestone 
             payment was triggered by the rapid rate of prescreening in the 
             potentially registrational Phase 2b ReTain trial investigating 
             active-immunotherapy candidate JNJ-2056 (ACI-35.030) to treat 
             preclinical AD; and 
 
          -- The efforts made under the agreement with Takeda for the 
             development, CMC, and regulatory activities. 
 
   -- R&D Expenditures: R&D expense increased by CHF 8.0 million for the year 
      ended December 31, 2024 to CHF 62.6 million, predominantly due to: 
 
          -- Discovery and preclinical expenses: Decrease of CHF 1.8 million, 
             primarily due to the completion of certain pre-clinical studies 
             and our strategic focus on advancing clinical-stage programs. As a 
             result, a greater proportion of our resources was allocated to 
             clinical development activities rather than discovery and 
             pre-clinical activities. 
 
          -- Clinical expenses: Increase of CHF 8.8 million, primarily due to 
             an increase of activities in our Phase 1b/2 ABATE study of 
             ACI-24.060, and our Phase 2 VacSYn study of ACI-7104.056. This was 
             partially offset by a decrease of CHF 0.8 million for the clinical 
             development of ACI-35.030, driven by the completion of the prior 
             Phase 1b/2a trial and its progression into the Phase 2b ReTain 
             trial, where the costs are borne by Janssen. 
 
          -- Salary- and benefit-related costs: Increase of CHF 1.0 million, 
             primarily due to the annualization of 2023 hires and additional 
             new hires during the year, which resulted in an increase in 
             salary- and benefit-related costs of CHF 0.7 million, and CHF 0.3 
             million in share-based compensation expense. 
 
   -- G&A Expenditures: G&A expenses increased by CHF 2.0 million for the year 
      ended December 31, 2024, to CHF 17.3 million. This increase is due to 
      legal fees related to business development and licensing activities, as 
      well as salaries and related costs, largely attributable to the higher 
      expenses from equity awards granted in 2024, which have a higher fair 
      value based on our share price development. 
 
   -- IFRS Loss for the Period: The Company reported a net loss after taxes of 
      CHF 50.9 million for the year ended December 31, 2024, compared with a 
      net loss of CHF 54.2 million for the prior period. 

2025 Financial Guidance

   -- For the full year 2025, the Company expects its total cash expenditure to 
      be in the range of CHF 75--85 million. The Company defines total cash 
      expenditure as operating expenditures adjusted to include capital 
      expenditures and offset by significant non-cash items (including 
      share-based compensation and depreciation expense). 

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(R) and Morphomer(R), fuel its broad and diversified pipeline of first- and best-in-class assets, which currently features sixteen therapeutic and diagnostic programs, including five in Phase 2 development and one in Phase 3. 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(R) is a registered trademark of AC Immune SA in the following territories: AU, EU, CH, GB, JP, RU, SG and USA. Morphomer(R) is a registered trademark of AC Immune SA in CN, CH, GB, JP, KR, NO and RU.

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     U.S. Investors Christina Tartaglia 
 Communications                         Precision AQ Phone: +1 332 322 7430 
 Gary Waanders, Ph.D., MBA              Email: 
 AC Immune                              christina.tartaglia@precisionaq.com] 
 Phone: +41 21 345 91 91 
 Email: gary.waanders@acimmune.com 
International Media Chris Maggos 
Cohesion Bureau Phone: +41 79 367 6254 
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.

Consolidated Balance Sheets

(In CHF thousands)

 
                                As of 
                                     December 31, 
                                    2024        2023 
Assets 
Non-current assets 
Property, plant and 
 equipment                             2,651      3,376 
Right-of-use assets                    5,437      3,508 
Intangible asset                      50,416     50,416 
Long-term financial 
 assets                                  415        361 
Total non-current 
 assets                               58,919     57,661 
 
Current assets 
Prepaid expenses                       4,302      6,437 
Accrued income                         1,099        246 
Other current 
 receivables                           1,104        622 
Accounts receivable                       --     14,800 
Short-term financial 
 assets                              129,214     24,554 
Cash and cash 
 equivalents                          36,275     78,494 
Total current assets                 171,994    125,153 
Total assets                         230,913    182,814 
 
Shareholders' equity 
and liabilities 
 
Shareholders' equity 
Share capital                          2,226      2,089 
Share premium                        478,506    474,907 
Treasury shares                        (218)      (105) 
Currency translation 
 differences                             (5)       (51) 
Accumulated losses                 (368,239)  (316,197) 
Total shareholders' 
 equity                              112,270    160,643 
 
Non-current 
liabilities 
Long-term deferred 
contract revenue                       4,560         -- 
Long-term lease 
 liabilities                           4,401      2,825 
Net employee defined 
 benefit 
 liabilities                           8,844      5,770 
Total non-current 
 liabilities                          17,805      8,595 
 
Current liabilities 
Trade and other 
 payables                              2,658      1,679 
Accrued expenses                      12,098     11,087 
Short-term deferred 
 income                                   --        138 
Short-term deferred 
contract revenue                      85,056         -- 
Short-term lease 
 liabilities                           1,026        672 
Total current 
 liabilities                         100,838     13,576 
Total liabilities                    118,643     22,171 
Total shareholders' 
 equity and 
 liabilities                         230,913    182,814 
 

Consolidated Statements of Income/(Loss)

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

 
 
 
 
 
                                        For the Year Ended 
                                                December 31, 
                                          2024      2023      2022 
Revenue 
Contract revenue                          27,309    14,801     3,935 
Total revenue                             27,309    14,801     3,935 
 
Operating expenses 
Research & development expenses         (62,570)  (54,606)  (60,336) 
General & administrative expenses       (17,259)  (15,305)  (15,789) 
Other operating income/(expense), net        142     1,486     1,343 
Total operating expenses                (79,687)  (68,425)  (74,782) 
Operating loss                          (52,378)  (53,624)  (70,847) 
 
Financial income                           3,196     1,044        69 
Financial expense                          (133)     (176)     (355) 
Exchange differences                     (1,598)   (1,467)       393 
Finance result, net                        1,465     (599)       107 
 
Loss before tax                         (50,913)  (54,223)  (70,740) 
Income tax expense                           (3)      (10)      (13) 
Loss for the period                     (50,916)  (54,233)  (70,753) 
 
Loss per share: 
Basic and diluted loss for the period 
 attributable to equity holders           (0.51)    (0.64)    (0.85) 
 

Consolidated Statements of Comprehensive Income/(Loss)

(In CHF thousands)

 
                            For the Year Ended 
                                    December 31, 
                              2024      2023      2022 
Loss for the 
 period                     (50,916)  (54,233)  (70,753) 
Items that may be 
reclassified to 
income or loss in 
subsequent periods 
(net of tax): 
Currency 
 translation 
 differences                      46      (61)        10 
Items that will 
not to be 
reclassified to 
income or loss in 
subsequent periods 
(net of tax): 
Remeasurement 
 gains/(losses) on 
 defined-benefit 
 plans (net of 
 tax)                        (3,084)   (1,669)     4,426 
Other 
 comprehensive 
 income/(loss)               (3,038)   (1,730)     4,436 
Total 
 comprehensive 
 loss, net of tax           (53,954)  (55,963)  (66,317) 
 

Attachment

   -- 20250313__ACIU FY2024 financial results_FINAL 

(END) Dow Jones Newswires

March 13, 2025 07:00 ET (11:00 GMT)