AC Immune Q2 2024 Financial Results and Corporate Update

AC Immune SA, a clinical-stage biopharmaceutical firm renowned for its precision therapeutics targeting neurodegenerative diseases, has unveiled its financial outcomes for the second quarter of 2024 and shared significant corporate updates. The company, based in Lausanne, Switzerland, continues to make strides in its efforts to combat Alzheimer's disease (AD) and Parkinson's disease (PD) through its advanced drug development programs.

One of the key announcements from AC Immune is its partnership with Takeda for the development of ACI-24.060, an active immunotherapy aimed at targeting Abeta in Alzheimer's disease. This collaboration, initiated on May 13, involves a substantial upfront payment of $100 million from Takeda, with the potential for additional milestone payments totaling approximately $2.1 billion. This move is seen as a critical step towards advancing ACI-24.060, which is currently in the ABATE Phase 2 trial for AD, progressing well with enrolment targets.

Moreover, the company has reported significant progress in its other clinical programs. The ACI-7104.056 VacSYn Phase 2 trial, an anti-a-syn active immunotherapy for Parkinson’s disease, is on schedule, with safety and immunogenicity interim data expected in the second half of 2024. Additionally, AC Immune’s preclinical candidate, ACI-19764, a potent inhibitor of the inflammatory NLRP3 pathway, has shown promising results in preclinical studies. This compound holds potential for treating both central nervous system (CNS) and non-CNS diseases.

Financially, AC Immune is in a robust position. The company's cash reserves stood at CHF 175.2 million at the end of the quarter, bolstered by CHF 92.3 million from the Takeda agreement. This substantial cash balance is projected to support the company’s operations for the next three years, ensuring sustained investment in its research and development programs.

Dr. Andrea Pfeifer, CEO of AC Immune, expressed optimism about the company's trajectory, highlighting the excitement surrounding the Takeda partnership and the progress in ongoing trials. Dr. Pfeifer also emphasized the potential of the company’s innovative morADC platform, which combines the SupraAntigen® and Morphomer® technologies. This platform is designed to enhance targeted interventions for various neurodegenerative diseases and could enable simultaneous combination therapies. Early preclinical models have shown encouraging results, and more detailed updates are anticipated in the upcoming R&D day.

Quarterly highlights also included progress in the regulatory and preclinical fronts. The company completed regulatory toxicology studies for its anti-TDP-43 monoclonal antibody candidate, paving the way for an Investigational New Drug (IND) filing. Additionally, promising data from the company’s NLRP3 inhibitor candidates were presented at the AD/PD™ 2024 conference, showcasing the brain-penetrant properties and safety profile of ACI-19764.

AC Immune’s advancements were further underlined at the Alzheimer’s Association International Conference (AAIC) 2024. Presentations included breakthrough data on the morADC platform, demonstrating its potential in targeting neurodegenerative diseases, the immunological efficacy of ACI-24.060 in non-human primates, and the discovery of a novel TDP-43 PET tracer, [18F]ACI-19626, intended for detecting and monitoring TDP-43 aggregates.

Looking ahead, AC Immune has a series of anticipated milestones for the remainder of 2024. These include an update on the Phase 2 VacSYn study for ACI-7104.056 in PD, the initiation of Phase 1 trials for a TDP-43 PET tracer, and the completion of IND-enabling studies for an a-syn-PET tracer in PD.

Financially, the company reported an increase in R&D expenditures to CHF 17.1 million, driven by the expansion of clinical activities, particularly for the Phase 2 VacSYn study and the ABATE study. General and administrative expenses also saw a rise, mainly due to increased legal fees and higher costs associated with equity awards.

In summary, AC Immune’s second quarter of 2024 underscores a period of significant progress and strategic partnerships, particularly with Takeda. The company’s solid financial foundation and robust pipeline of therapeutic and diagnostic programs position it well to continue its pioneering work in addressing neurodegenerative diseases.