AC Immune Reports Third Quarter 2023 Financial Results and Provides a Corporate Update

AC Immune Reports Third Quarter 2023 Financial Results and Provides a Corporate Update

• Results from amyloid plaque discount evaluation (Abeta-PET) after 6 months of remedy with ACI-24.060 in ABATE Phase 1b/2 research on observe for H1 2024

  

• ACI-24.060 ABATE interim security and immunogenicity information in Alzheimer’s illness (AD) anticipated by year-end

• ACI-7104.056 alpha-synuclein energetic immunotherapy in Phase 2 ‘VacSYn’ Parkinson’s illness (PD) trial to finish Cohort 1 enrollment and report preliminary security findings by year-end

• Cash position of CHF 79.9 million funds the Company into This autumn 2024, excluding the advantage of anticipated milestone funds

Lausanne, Switzerland, November 3, 2023 – AC Immune SA (NASDAQ: ACIU), a clinical-stage biopharmaceutical firm pioneering precision drugs for neurodegenerative ailments, immediately reported outcomes for the third quarter ended September 30, 2023, and supplied a company update.

Dr. Andrea Pfeifer, CEO of AC Immune SA, commented: “As we look to year-end and into 2024, AC Immune is poised to achieve multiple milestones across our clinical programs. We remain on track to report safety and immunogenicity data from the AD cohort of our ABATE trial of ACI-24.060 this year. Then, in the first half of 2024 results are anticipated from the important Abeta-PET imaging analyses on amyloid plaque reduction following 6 months of treatment. With amyloid clearance as measured by PET imaging now established as a reliable surrogate for efficacy, these results could significantly de-risk the program and enable advancement into a registrational study. We look forward to further discussing the clinical utility of PET imaging in AD at our KOL webinar on November 9, 2023.”

“We continue to progress our pipeline, and are looking forward to the initiation of the next AD trial of anti-pTau (phosphorylated Tau) active immunotherapy ACI-35.030 later this year, which will be followed by a milestone payment. Taken together with ACI-24.060 and our a-syn active immunotherapy, ACI-7104.056, we will have three active immunotherapies in mid- to late-stage clinical testing for neurodegeneration. With further clinical readouts from our precision medicine pipeline ahead, we continue to work diligently towards earlier diagnosis and treatment to prevent progression of neurodegenerative diseases.”

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Q3 2023 and Subsequent Highlights

• A peer-reviewed paper that includes the first-in-human trial of AC Immune’s wholly owned experimental alpha-synuclein (a-syn) positron emission tomography (PET) tracer ACI-12589 evaluating wholesome management topics to sufferers with a-synucleinopathies and different neurological diagnoses was published in Nature Communications.

• KOL webinar on PET imaging in AD that includes Victor Villemagne, M.D. (University of Pittsburg) can be held on November 9, 2023 at 10:00 AM ET. To register for the occasion, please click here.

• The first affected person with PD was dosed within the Phase 2 VacSYn medical trial evaluating ACI-7104.056, AC Immune’s wholly-owned anti-a-syn energetic immunotherapy.

• Several applications had been showcased on the annual Alzheimer’s Association International Conference (AAIC 2023), together with displays on ABATE’s trial design, TDP-43 proteinopathy in neurodegenerative ailments, and ACI-12589, a novel PET tracer concentrating on a-syn.

• Announced the appointment of recent Chief Medical Officer, Dr Nuno Mendonça.

• Initiated a analysis collaboration with Prof. Michael Heneka, director of the Luxembourg Centre for Systems Biomedicine, University of Luxembourg, to guage the therapeutic potential of AC Immune’s SupraAntigen^®– and Morphomer^®-derived inhibitors of the NLRP3-ASC inflammasome pathway in preclinical illness fashions.

Anticipated Milestones

Analysis of Financial Statements for the Quarter Ended September 30, 2023

• Cash Position: The Company ended Q3 with a complete money steadiness of CHF 79.9 million (CHF 122.6 million as of December 31, 2022), composed of CHF 31.9 million in money and money equivalents and CHF 48.0 million in short-term monetary belongings. The Company’s money steadiness offers ample capital sources to progress into This autumn 2024 with out contemplating receipt of potential future milestone funds.

• R&D Expenditures: R&D bills for the three months ended September 30, 2023, had been CHF 12.4 million in comparison with CHF 14.4 million within the comparable interval in 2022, attributable to decrease bills in our preclinical portfolio and diminished medical bills.

• G&A Expenditures: For the three months ended September 30, 2023, G&A elevated by CHF 0.2 million, which is materially in step with the comparable interval.

• Other Operating Income: The Company acknowledged CHF 0.3 million in grant revenue from Michael J. Fox Foundation and Target ALS grants.

• IFRS Loss for the Period: The Company reported a internet loss after taxes of CHF 15.1 million for the three months ended September 30, 2023, in contrast with a internet lack of CHF 13.5 million for the comparable interval in 2022.

About AC Immune SA
AC Immune SA is a clinical-stage biopharmaceutical firm that goals to turn out to be a world chief in precision drugs for neurodegenerative ailments, together with Alzheimer’s illness, Parkinson’s illness, and NeuroOrphan indications pushed by misfolded proteins. The Company’s two clinically validated know-how platforms, SupraAntigen^® and Morphomer^®, gasoline its broad and diversified pipeline of first- and best-in-class belongings, which at present options sixteen therapeutic and diagnostic applications, 5 of that are at present in Phase 2 medical trials and certainly one of which is in Phase 3. AC Immune has a powerful observe file of securing strategic partnerships with main world pharmaceutical firms together with Genentech, a member of the Roche Group, Eli Lilly and Company, and others, leading to substantial non-dilutive funding to advance its proprietary applications and >$3 billion in potential milestone funds.

SupraAntigen^® is a registered trademark of AC Immune SA within 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 info on our web site and another web sites referenced herein is expressly not included by reference into, and doesn’t represent part of, this press launch.

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Forward trying statements
This press launch incorporates statements that represent “forward-looking statements” throughout the that means of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. Forward-looking statements are statements aside from historic reality and will embrace statements that deal with future working, monetary or business efficiency or AC Immune’s methods or expectations. In some instances, you possibly can establish these statements by forward-looking phrases corresponding to “may,” “might,” “will,” “should,” “expects,” “plans,” “anticipates,” “believes,” “estimates,” “predicts,” “projects,” “potential,” “outlook” or “continue,” and different comparable terminology. Forward-looking statements are based mostly on administration’s present expectations and beliefs and contain vital dangers and uncertainties that would trigger precise outcomes, developments and business choices to vary materially from these contemplated by these statements. These dangers and uncertainties embrace these described below 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 different filings with the Securities and Exchange Commission. Forward-looking statements converse solely as of the date they’re made, and AC Immune doesn’t undertake any obligation to update them in gentle of recent info, future developments or in any other case, besides as could also be required below relevant regulation. All forward-looking statements are certified of their entirety by this cautionary assertion.

Condensed Consolidated Balance Sheets (Unaudited)
(In CHF 1000’s)

Condensed Consolidated Statements of Income/(Loss) (Unaudited)
(In CHF 1000’s, apart from per-share information)

Condensed Consolidated Statements of Comprehensive Income/(Loss) (Unaudited)
(In CHF 1000’s)

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