Full Press Release Details
Lausanne, Switzerland,
March 14, 2024 - AC Immune SA (NASDAQ: ACIU), a clinical-stage biopharmaceutical company pioneering the development of
precision medicine approaches for the diagnosis, treatment, and prevention of neurodegenerative diseases, today reported results for
the year ended December 31, 2023, and provided a corporate update.
Pfeifer, CEO of AC Immune SA, commented: "We made significant progress in 2023 advancing our three innovative
active immunotherapy programs in Phase 2 clinical trials in Alzheimer's and Parkinson's diseases. This sets the stage for
a number of important milestones in 2024, which have the potential to further enhance our understanding of how best to prevent neurodegeneration
and to generate significant value for AC Immune. In the second quarter and second half of 2024, we will be reporting Phase 2 ACI-24.060
data on amyloid plaque reduction after 6- and 12-months treatment, respectively. Amyloid plaque is a clinically validated biomarker of
efficacy, making these data announcements potentially de-risking and providing an opportunity to accelerate ACI-24.060 into a registrational
are also delighted that ACI-35.030 (JNJ-64042056), our anti-phospho-Tau active immunotherapy, has now entered the Phase 2b trial, conducted
by our partner in pre-symptomatic AD patients. In addition, our ACI-7104.056 anti-alpha-synuclein active immunotherapy is advancing through
Phase 2 testing for Parkinson's disease (PD) with initial safety and immunogenicity data expected in the second half of 2024.
Immune's primary focus remains on these three active immunotherapy programs, each of which has the potential to transform how neurodegenerative
diseases are treated and ultimately, to enable precision prevention of these diseases. Thanks to our strengthened leadership team and
reinforced balance sheet, we are well-positioned to deliver de-risking clinical milestones, working towards our mission to shift the
paradigm from disease treatment to disease prevention."
and Subsequent Highlights
Immunotherapy Programs
anti-Abeta active immunotherapy
(JNJ-64042056) anti-phospho-Tau (anti-pTau) active immunotherapy
anti-a-syn active immunotherapy
| ACI-24.060 anti-Abeta active immunotherapy | 6-month and 12-month Abeta-PET data in AD expected in Q2 2024 and H2 2024, respectively Initial safety and immunogenicity data in DS cohort expected in H2 2024 |
| ACI-7104.056 anti-a-syn active immunotherapy | Interim safety and immunogenicity update from the Phase 2 VacSYn study in Parkinson's disease expected in H2 2024 |
| ACI-35.030 anti-pTau active immunotherapy | First-patient in ReTain Phase 2b clinical trial expected in H1 2024 |
| Anti-TDP-43 antibody | Completion of regulatory tox studies expected in H1 2024 |
| TDP-43-PET tracer | Phase 1 initiation expected in H2 2024 |
| ACI-15916 a-syn-PET tracer | IND-enabling studies in PD expected to be completed in H2 2024 |
of Financial Statements for the Year Ended December 31, 2023
| o | Discovery and preclinical expenses (- CHF 5.8 million) : The Company decreased expenditures across a variety of its discovery and preclinical programs. | |
| o | Clinical expenses (- CHF 2.0 million): The Company had a net decrease in clinical expenditures largely due the completion of the Phase 1b/2a and the advancement into Phase 2b for our ACI-35.030 active immunotherapy. We increased expenditures for the continued clinical development of our Phase 1b/2 ABATE study for ACI-24.060. | |
| o | Salary- and benefit-related costs (+ CHF 2.2 million): While the staffing position remained stable in 2023, personnel expenses increased due to the annualization of 2022 hires. |
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, five of which are currently in Phase 2 clinical trials and one
of which is 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 in potential milestone payments plus royalties.
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.
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 Corey Davis, Ph.D. LifeSci Advisors Phone: +1 212 915 2577 Email: cdavis@lifesciadvisors.com |
| International Media Chris Maggos Cohesion Bureau Phone: +41 79 367 6254 Email: chris.maggos@cohesionbureau.com |
Forward looking statements
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.
| As of | ||||||||
| December 31, | ||||||||
| 2023 | 2022 | |||||||
| Assets | ||||||||
| Non-current assets | ||||||||
| Property, plant and equipment | 3,376 | 4,259 | ||||||
| Right-of-use assets | 3,508 | 2,808 | ||||||
| Intangible asset | 50,416 | 50,416 | ||||||
| Long-term financial assets | 361 | 361 | ||||||
| Total non-current assets | 57,661 | 57,844 | ||||||
| Current assets | ||||||||
| Prepaid expenses | 6,437 | 4,708 | ||||||
| Accrued income | 246 | 408 | ||||||
| Other current receivables | 622 | 392 | ||||||
| Accounts receivable | 14,800 | - | ||||||
| Short-term financial assets | 24,554 | 91,000 | ||||||
| Cash and cash equivalents | 78,494 | 31,586 | ||||||
| Total current assets | 125,153 | 128,094 | ||||||
| Total assets | 182,814 | 185,938 | ||||||
| Shareholders' equity and liabilities | ||||||||
| Shareholders' equity | ||||||||
| Share capital | 2,089 | 1,797 | ||||||
| Share premium | 474,907 | 431,323 | ||||||
| Treasury shares | (105 | ) | (124 | ) | ||||
| Currency translation differences | (51 | ) | 10 | |||||
| Accumulated losses | (316,197 | ) | (264,015 | ) | ||||
| Total shareholders' equity | 160,643 | 168,991 | ||||||
| Non-current liabilities | ||||||||
| Long-term lease liabilities | 2,825 | 2,253 | ||||||
| Net employee defined benefit liabilities | 5,770 | 3,213 | ||||||
| Total non-current liabilities | 8,595 | 5,466 | ||||||
| Current liabilities | ||||||||
| Trade and other payables | 1,679 | 929 | ||||||
| Accrued expenses | 11,087 | 9,417 | ||||||
| Deferred income | 138 | 587 | ||||||
| Short-term lease liabilities | 672 | 548 | ||||||
| Total current liabilities | 13,576 | 11,481 | ||||||
| Total liabilities | 22,171 | 16,947 | ||||||
| Total shareholders' equity and liabilities | 182,814 | 185,938 |
Statements of Income/(Loss)
except for per-share data)
| For the Year Ended | ||||||||||||
| December 31, | ||||||||||||
| 2023 | 2022 | 2021 | ||||||||||
| Revenue | ||||||||||||
| Contract revenue | 14,801 | 3,935 | - | |||||||||
| Total revenue | 14,801 | 3,935 | - | |||||||||
| Operating expenses | ||||||||||||
| Research & development expenses | (54,606 | ) | (60,336 | ) | (62,282 | ) | ||||||
| General & administrative expenses | (15,305 | ) | (15,789 | ) | (17,910 | ) | ||||||
| Other operating income/(expense), net | 1,486 | 1,343 | 1,182 | |||||||||
| Total operating expenses | (68,425 | ) | (74,782 | ) | (79,010 | ) | ||||||
| Operating loss | (53,624 | ) | (70,847 | ) | (79,010 | ) | ||||||
| Financial income | 1,044 | 69 | 6,485 | |||||||||
| Financial expense | (176 | ) | (355 | ) | (581 | ) | ||||||
| Exchange differences | (1,467 | ) | 393 | 113 | ||||||||
| Finance result, net | (599 | ) | 107 | 6,017 | ||||||||
| Loss before tax | (54,223 | ) | (70,740 | ) | (72,993 | ) | ||||||
| Income tax expense | (10 | ) | (13 | ) | (3 | ) | ||||||
| Loss for the period | (54,233 | ) | (70,753 | ) | (72,996 | ) | ||||||
| Loss per share: | ||||||||||||
| Basic and diluted loss for the period attributable to equity holders | (0.64 | ) | (0.85 | ) | (0.97 | ) |
Statements of Comprehensive Income/(Loss)
| For the Year Ended | ||||||||||||
| December 31, | ||||||||||||
| 2023 | 2022 | 2021 | ||||||||||
| Loss for the period | (54,233 | ) | (70,753 | ) | (72,996 | ) | ||||||
| Items that may be reclassified to income or loss in subsequent periods (net of tax): | ||||||||||||
| Currency translation differences | (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) | (1,669 | ) | 4,426 | 956 | ||||||||
| Other comprehensive income/(loss) | (1,730 | ) | 4,436 | 956 | ||||||||
| Total comprehensive loss, net of tax | (55,963 | ) | (66,317 | ) | (72,040 | ) |