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

Rhea-AI Summary

AC Immune (NASDAQ: ACIU) reported its full year 2024 financial results, highlighting a landmark deal with Takeda worth $100 million upfront and potential milestones up to $2.1 billion plus royalties for ACI-24.060. The company received a CHF 24.6 million milestone payment from Janssen for enrollment progress in the JNJ-2056 Phase 2b trial.

Key financial metrics include:

• Cash position of CHF 165.5 million, providing funding into Q1 2027
• Contract revenues of CHF 27.3 million in 2024
• R&D expenses increased to CHF 62.6 million
• Net loss of CHF 50.9 million

Clinical progress includes positive interim safety data for ACI-24.060 in Down syndrome patients and encouraging results for ACI-7104.056 in Parkinson's disease. The company expects 2025 total cash expenditure between CHF 75-85 million.

Positive

• Secured $100M upfront payment from Takeda deal with potential $2.1B in milestones
• Received CHF 24.6M milestone payment from Janssen
• Strong cash position of CHF 165.5M providing runway into Q1 2027
• JNJ-2056 received FDA Fast Track Designation
• Positive interim safety data in clinical trials for key drug candidates

Negative

• Increased R&D expenses by CHF 8.0M to CHF 62.6M
• Net loss of CHF 50.9M for 2024
• Higher G&A expenses, up CHF 2.0M to CHF 17.3M

Insights

Financial Analyst

AC Immune's 2024 financial results reveal a significantly strengthened financial position driven by the landmark $100 million upfront payment from Takeda and a CHF 24.6 million milestone payment from Janssen. The Takeda deal for ACI-24.060 represents transformative validation with potential additional milestones reaching $2.1 billion plus tiered double-digit royalties.

The company's cash position of CHF 165.5 million provides runway into Q1 2027, representing approximately two years of operations based on projected 2025 cash expenditure of CHF 75-85 million. This financial cushion allows AC Immune to advance multiple clinical programs without immediate capital raising needs.

Contract revenues increased substantially to CHF 27.3 million from CHF 14.8 million in the prior year. While R&D expenses rose to CHF 62.6 million (up CHF 8.0 million) and G&A expenses increased to CHF 17.3 million (up CHF 2.0 million), the net loss slightly improved to CHF 50.9 million from CHF 54.2 million previously.

The multiple external validations through partnerships, milestone achievements, and regulatory designations (including FDA Fast Track) enhance AC Immune's position as a leader in neurodegenerative disease therapeutics. While continued operating losses reflect typical biotech development stage investments, the company's strengthened balance sheet substantially de-risks its financial outlook.

Biotechnology Specialist

AC Immune's pipeline progress in 2024 demonstrates significant clinical momentum across multiple neurodegenerative disease programs. The company is advancing a differentiated approach focused on precision prevention rather than just treatment of established disease.

The ABATE Phase 1b/2 trial for ACI-24.060 showed encouraging interim safety and tolerability in Down syndrome patients with no serious adverse events related to the study drug and no cases of ARIA (amyloid-related imaging abnormalities) – a critical safety differentiator from antibody approaches. The program will now evaluate a higher dose cohort, suggesting a favorable safety profile.

For JNJ-2056 (ACI-35.030), the FDA Fast Track designation and UK Innovation Passport underscore regulatory recognition of this anti-phospho-Tau immunotherapy's potential. The rapid prescreening rate in the Phase 2b ReTain trial indicates strong investigator interest and efficient trial execution.

The VacSYn trial of ACI-7104.056 demonstrated positive interim immunogenicity with induced antibody responses 16-fold higher than placebo after three immunizations, suggesting robust target engagement. The favorable safety profile with primarily mild injection site reactions (49%) and headaches (18%) supports the potential for this active immunotherapy approach in Parkinson's disease.

The company's dual technology platforms (SupraAntigen and Morphomer) continue generating new candidates, including the novel morADC antibody-drug conjugate technology combining brain-penetrant small molecules with monoclonal antibodies – representing potentially significant intellectual property beyond current clinical assets.

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 (NASDAQ: 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) 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) 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™ 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^® with SupraAntigen^® monoclonal antibodies and holds substantial promise in our fight against neurodegeneration.
  

Anticipated 2025 Milestones

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

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® and Morphomer®, 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® 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, 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 Communications Gary Waanders, Ph.D., MBA AC Immune Phone: +41 21 345 91 91 Email: gary.waanders@acimmune.com	U.S. Investors Christina Tartaglia Precision AQ Phone: +1 332 322 7430 Email: christina.tartaglia@precisionaq.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

FAQ

What is the value of AC Immune's deal with Takeda for ACI-24.060?

The deal includes $100M upfront payment and potential milestone payments up to $2.1B, plus tiered double-digit royalties on worldwide sales.

How long will ACIU's current cash position last?

The company's cash position of CHF 165.5M provides funding into Q1 2027, assuming no additional milestone payments.

What were AC Immune's (ACIU) financial results for 2024?

ACIU reported contract revenues of CHF 27.3M, R&D expenses of CHF 62.6M, and a net loss of CHF 50.9M for 2024.

What is ACIU's expected cash expenditure for 2025?

AC Immune expects total cash expenditure between CHF 75-85 million for 2025.

What clinical progress did ACIU make with ACI-24.060 in 2024?

ACI-24.060 showed positive interim safety data in Down syndrome patients with no serious adverse events and no ARIA cases.