| ◾ | Initiated a research collaboration with Prof. Michael Heneka, director of the Luxembourg Centre for Systems Biomedicine, University of Luxembourg, to evaluate the therapeutic potential of AC Immune’s SupraAntigen®- and Morphomer®-derived inhibitors of the NLRP3-ASC inflammasome pathway in preclinical disease models. |
Anticipated Milestones
ACI-24.060
anti-Abeta active immunotherapy | ● Additional interim safety and immunogenicity data from AD cohorts of ABATE study expected in Q4 2023 ● First Abeta-PET data on amyloid plaque reduction in AD following 6 months of treatment expected in H1 2024 |
ACI-7104.056 anti-a-syn active immunotherapy | ● Completion of cohort 1 enrollment and initial safety findings in the Phase 2 VacSYn study in PD expected by year-end |
ACI-35.030 anti-pTau active immunotherapy | ● Initiation of next trial in AD expected in Q4 2023 (to be followed by a milestone payment) |
Anti-TDP-43 antibody | ● Advancement of candidate into preclinical development (tox) expected in Q4 2023 |
a-syn-PET tracer | ● Declaration of next clinical candidate for development in PD expected in Q4 2023 |
Analysis of Financial Statements for the Quarter Ended September 30, 2023
| ◾ | Cash Position: The Company ended Q3 with a total cash balance of CHF 79.9 million (CHF 122.6 million as of December 31, 2022), composed of CHF 31.9 million in cash and cash equivalents and CHF 48.0 million in short-term financial assets. The Company’s cash balance provides sufficient capital resources to progress into Q4 2024 without considering receipt of potential future milestone payments. |
| ◾ | R&D Expenditures: R&D expenses for the three months ended September 30, 2023, were CHF 12.4 million compared to CHF 14.4 million in the comparable period in 2022, due to lower expenses in our preclinical portfolio and reduced clinical expenses. |
| ◾ | G&A Expenditures: For the three months ended September 30, 2023, G&A increased by CHF 0.2 million, which is materially consistent with the comparable period. |
| ◾ | Other Operating Income: The Company recognized CHF 0.3 million in grant income from Michael J. Fox Foundation and Target ALS grants. |
| ◾ | IFRS Loss for the Period: The Company reported a net loss after taxes of CHF 15.1 million for the three months ended September 30, 2023, compared with a net loss of CHF 13.5 million for the comparable period in 2022. |
About AC Immune SA
AC Immune SA is a clinical-stage biopharmaceutical company that aims to become a global leader in precision medicine 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 including Genentech, a member of the Roche Group, Eli Lilly and Company, and others, resulting in substantial non-dilutive funding to advance its proprietary programs and >$3 billion in potential milestone payments.
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:
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Head of 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
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.
