A/C Immune Reports Second Quarter 2023 Financial Results and

A/C Immune Reports Second Quarter 2023 Financial Results and Provides a Corporate Update

• Received FDA Fast Track Designation for ACI-24.060 anti-amyloid-beta (Abeta) active immunotherapy to treat Alzheimer’s illness (ADVERTISEMENT)
• Enrollment in continuous Phase 1b/2 ABATE research study of ACI-24.060 in ADVERTISEMENT and Down syndrome (DS) is on track and broadening to websites in U.S.A. following IND clearance, dosed initially specific with DS
• Next interim safety and immunogenicity information from advertisement and DS mates in ABATE anticipated in H2 2023
• Results of amyloid plaque decrease analysis (Abeta-ANIMAL) after treatment with ACI-24.060 in ABATE research study anticipated in H1 2024; these outcomes might possibly offer a chance to speed up into a registrational program
• Cash position of CHF 93.0 million financial resources the Company into Q3 2024, omitting the advantage of expected turning point payments

Lausanne, Switzerland, August 4, 2023 – A/C Immune SA (NASDAQ: ACIU), a clinical-stage biopharmaceutical business pioneering accuracy medication for neurodegenerative illness, today reported outcomes for the 2nd quarter ended June 30, 2023, and supplied a business update.

Dr. Andrea Pfeifer, CEO of A/C Immune SA, commented:  “We entered the second half of 2023 with strong momentum. ACI-24.060’s Fast Track designation acknowledges its potential as a next-generation anti-Abeta active immunotherapy positioned to offer best-in-class efficacy, an improved safety profile, and fewer administration and distribution constraints compared to monoclonal antibodies. With our ABATE trial enrolling AD patients in Europe and expanding the DS cohort via US sites, ACI-24.060 is moving expeditiously towards additional interim safety and immunogenicity data, and Abeta-PET imaging analyses on amyloid plaque reduction in AD in the first half of 2024. Demonstration of Abeta plaque clearance, a validated surrogate marker for clinical efficacy, would provide a major opportunity to rapidly transition to a registrational program.”

“We also look forward to the initiation of the next AD trial of ACI-35.030, the anti-pTau (phosphorylated Tau) active immunotherapy later this year, to be followed by a milestone payment. The progress of our programs affirms our commitment to developing precision medicine approaches to improve outcomes for patients, and ultimately, to prevent progression of neurodegenerative diseases through earlier diagnosis and early intervention.”

Q2 2023 and Subsequent Highlights

• Received Fast Track classification from the U.S. Food and Drug Administration (FDA) for ACI-24.060, A/C Immune’s wholly-owned SupraAntigen^®-based anti-Abeta active immunotherapy prospect, for the treatment of advertisement.
• Ongoing Phase 1b/2 ABATE research study of ACI-24.060 in clients with advertisement and people with DS is on track and broadening to websites in the U.S.A. following FDA Investigational New Drug (IND) clearance.
• The very first individual with DS was dosed in the Phase 1b/2 ABATE trial.
• The very first client with Parkinson’s illness was dosed in the Phase 2 VacSYn medical trial examining ACI-7104.056, A/C Immune’s wholly-owned anti-alpha-synuclein (a-syn) active immunotherapy.
• Several programs were showcased at the yearly Alzheimer’s Association International Conference (AAIC 2023), that included a poster detailing ABATE’s trial style, a “Perspectives Session” concentrated on TDP-43 proteinopathy in neurodegenerative illness arranged by air conditioner Immune researchers, and an oral discussion revealing in-depth information on ACI-12589, an unique positron emission tomography (ANIMAL) tracer targeting a-syn.
• The TDP-43-PET tracer program has actually advanced as prepared and a scientific prospect has actually been picked. Over the coming months even more preclinical work will be finished to allow the initiation of a very first in human research study in 2024.
• A peer-reviewed paper explaining our restorative antibody prospect targeting TDP-43 was released in the journal ‘mAbs’.
• Initiated a research study cooperation with Prof. Michael Heneka, director of the Luxembourg Centre for Systems Biomedicine, University of Luxembourg, to more assess the restorative capacity of air conditioner Immune’s SupraAntigen^®– and Morphomer^®-obtained inhibitors of the NLRP3-ASC inflammasome path in preclinical illness designs.
• Hosted a webinar on early medical diagnosis and avoidance of advertisement including discussions by crucial viewpoint leaders Kaj Blennow, MD, PhD, of University of Gothenburg and Sahlgrenska University Hospital, and Giovanni Frisoni, MD, of University of Geneva and the Memory Clinic at Geneva University Hospital. To see a replay of the webinar, click on this link.
• Announced the appointment of brand-new Chief Medical Officer, Nuno Mendonça, MD.

Anticipated Milestones

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

• Cash Position: The Company ended Q2 with an overall money balance of CHF 93.0 million (CHF 122.6 million since December 31, 2022), made up of CHF 40.0 million in money and money equivalents and CHF 53.0 million in short-term monetary possessions. The Company’s money balance offers adequate capital resources to advance into a minimum of Q3 2024 without thinking about invoice of possible future turning point payments.
• R&D Expenditures: R&D expenditures for the 3 months ended June 30, 2023, were CHF 13.7 million compared to CHF 15.7 million in the equivalent duration in 2022. The decline was due generally to lower discovery and preclinical expenditures.
• G&A Expenditures: G&A reduced by CHF 0.7 million to CHF 3.7 million, mainly due to a decline in workers expenditures.
• Other Operating Income: The Company acknowledged CHF 0.3 million in grant earnings from Michael J. Fox Foundation and Target ALS grants.
• IFRS Loss for the Period: The Company reported a bottom line after taxes of CHF 16.8 million for the 3 months ended June 30, 2023, compared to a bottom line of CHF 19.6 million for the equivalent duration in 2022.

About A/C Immune SA
A/C Immune SA is a clinical-stage biopharmaceutical business that intends to end up being a worldwide leader in accuracy medication for neurodegenerative illness, consisting of Alzheimer’s illness, Parkinson’s illness, and NeuroOrphan signs driven by misfolded proteins. The Company’s 2 scientifically confirmed innovation platforms, SupraAntigen^® and Morphomer^®, fuel its broad and varied pipeline of very first- and best-in-class possessions, which presently includes sixteen restorative and diagnostic programs, 5 of which are presently in Phase 2 medical trials and among which remains in Phase 3. A/C Immune has a strong performance history of protecting tactical collaborations with leading worldwide pharmaceutical business consisting of Genentech, a member of the Roche Group, Eli Lilly and Company, and others, leading to significant non-dilutive financing to advance its exclusive programs and >$3 billion in possible turning point payments.

SupraAntigen^® is a signed up hallmark of A/C Immune SA in the list below areas: AU, EU, CH, GB, JP, RU, SG and U.S.A.. Morphomer^® is a signed up hallmark of A/C Immune SA in CN, CH, GB, JP, KR, NO and RU.

The details on our website and any other sites referenced herein is specifically not integrated by recommendation into, and does not make up a part of, this news release.

For more details, please contact:

Forward looking declarations
This news release includes declarations that make up “forward-looking statements” within the significance of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. Forward-looking declarations are declarations besides historic truth and might consist of declarations that deal with future operating, monetary or business efficiency or air conditioner Immune’s techniques or expectations. In some cases, you can recognize these declarations by positive words such as “may,” “might,” “will,” “should,” “expects,” “plans,” “anticipates,” “believes,” “estimates,” “predicts,” “projects,” “potential,” “outlook” or “continue,” and other equivalent terms. Forward-looking declarations are based upon management’s existing expectations and beliefs and include substantial dangers and unpredictabilities that might trigger real outcomes, advancements and business choices to vary materially from those pondered by these declarations. These dangers and unpredictabilities consist of those explained under the captions “Item 3. Key Information – Risk Factors” and “Item 5. Operating and Financial Review and Prospects” in A/C Immune’s Annual Report on Form 20-F and other filings with the Securities and Exchange Commission. Forward-looking declarations speak just since the date they are made, and A/C Immune does not carry out any responsibility to update them because of brand-new details, future advancements or otherwise, other than as might be needed under appropriate law. All positive declarations are certified in their totality by this cautionary declaration.

Condensed Consolidated Balance Sheets (Unaudited)
(In CHF thousands)

Condensed Consolidated Statements of Income/(Loss) (Unaudited)
(In CHF thousands, other than for per-share information)

Condensed Consolidated Statements of Comprehensive Income/(Loss) (Unaudited)
(In CHF thousands)

• 20230804_ACIU_Q2_Earnings_Final