Full Press Release Details
Full Year 2024 Financial Results and Provides a Corporate Update
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
ACI-35.030 (JNJ-2056) anti-phospho-Tau (anti-pTau) active immunotherapy
ACI-7104.056 anti-a-syn active immunotherapy
Small Molecule Programs
Thought and Innovation Leadership
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,
2025 Financial Guidance
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.
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
| 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)
| 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 | ) |