On November 8, 2021 AC Immune SA (NASDAQ: ACIU), a clinical-stage biopharmaceutical company pioneering precision medicine for neurodegenerative diseases, reported its financial results for the quarter ended September 30, 2021 and provided a corporate update (Press release, AC Immune, NOV 8, 2021, View Source [SID1234594738]).
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Prof. Andrea Pfeifer, CEO of AC Immune SA, commented: "AC Immune concluded an exceptional third quarter, highlighted by the acquisition of a clinical α-syn vaccine candidate in Parkinson’s disease and topline Phase 2 Lauriet data showing that semorinemab was the first Tau antibody candidate to significantly slow cognitive decline in mild-to-moderate Alzheimer’s disease patients. Our partner Genentech, a member of the Roche Group, will present the topline Lauriet data, later this week at the CTAD 2021 conference, where we will present new clinical data on our p-Tau and Abeta vaccine candidates, ACI-35 and ACI-24, respectively. These achievements show the commitment, progress and breadth of our leadership in discovering and developing impactful therapeutics for neurodegenerative diseases."
1 Total cash position does not include total gross proceeds of USD 30 million received in October 2021 from (i) USD 5 million as part of the Affiris asset acquisition and (ii) USD 25 million as part of a private placement with select group of Affiris investors.
Q3 2021 and Subsequent Highlights
Announced the first positive cognitive results for a Tau-targeting monoclonal antibody in Alzheimer’s disease (AD). Topline data from the Lauriet Phase 2 trial of semorinemab in mild-to-moderate AD showed a statistically significant (p<0.0025) 43.6% reduction at week 49 in cognitive decline vs. placebo as measured by ADAS-Cog11, one of the trial’s co-primary endpoints. The second co-primary endpoint, ADCS-ADL, was not met. AC Immune’s partner Genentech is continuing with the trial’s open label extension and is scheduled to present the topline data from the Lauriet study at the CTAD (Clinical Trials on Alzheimer’s Disease) conference on November 10, 2021, at 10:50am EST.
Completed an all-stock acquisition of Affiris’ portfolio of therapeutics targeting alpha-synuclein, notably PD01/ACI-7104, a clinically validated active vaccine candidate that places AC Immune at the forefront of Parkinson’s disease drug development. Through this acquisition and a concurrent financing, AC Immune has also strengthened its cash position and added Athos Service GmbH (Strüngmann family office), First Capital Partner GmbH (Egger Family Office), and MIG Fonds to its shareholder base.
Presented the full results from the landmark Phase 1b clinical trial evaluating the wholly-owned anti-Abeta vaccine ACI-24 in subjects with Down syndrome (DS) at the Alzheimer’s Association International Conference (AAIC) 2021. Data showed that ACI-24 generated immunogenicity along with a positive pharmacodynamic response and a favorable safety and tolerability profile. Based on these results, the Company plans to advance an optimized formulation of ACI-24 into mid-stage clinical testing to treat and prevent the progression of DS-related AD.
Extended the Company’s research partnership with leading scientists at the Center for Neurodegenerative Disease Research at the Perelman School of Medicine at the University of Pennsylvania (Penn). The goal of the collaboration is to further understand the role of distinct pathogenic TDP-43 species in the different TDP-43 proteinopathies. Through the development of novel experimental models, AC Immune and Penn hope to unravel the underlying mechanisms of cell-to-cell transmission of TDP-43 pathology that could provide new therapeutic strategies to target TDP-43-related proteinopathies.
Welcomed pharmaceutical industry expert Monica Shaw, M.D., and leading Swiss economist Prof. Monika Bütler, Dr. Oec., to the Company’s Board of Directors.
Announced that the Swiss Economic Forum (SEF) awarded AC Immune Co-Founder and CEO Prof. Andrea Pfeifer with the SEF.WomenAward for CEO of the Year. This award recognizes women with an excellent entrepreneurial track record, giving greater prominence to role models who can inspire the next generation of businesswomen.
Achieved and Anticipated 2021 milestones
Clinical Milestones
ACI-35.030 anti-pTau vaccine: reported Phase 1b/2a interim results in AD patients in Q1 (second highest dose); further Phase 1b/2a interim analysis in Q4 (highest dose)
JACI-35.054 alternative anti-pTau vaccine: reported a Phase 1b/2a interim analysis in AD patients in Q2 (low dose)
Alpha-synuclein PET imaging agent: advanced third-generation candidate to first-in-human clinical study in Q1; data to be presented at upcoming scientific meeting
ACI-24 anti-Abeta vaccine in DS: reported Phase 1b topline results in Q1
ACI-24 in AD: reported Phase 2, 12-month interim analysis in Q1; reporting full data set at CTAD in November 2021
Semorinemab anti-Tau antibody partnered with Genentech: topline results reported in Q3
Small molecule Morphomer Tau aggregation inhibitor program: select NeuroOrphan indication for further development in H2
ACI-24 in DS: submit investigational new drug (IND) application for optimized vaccine formulation in Q4
Preclinical Milestones
Alpha-synuclein small molecule inhibitor: identified first biologically active small molecule in Q1; start in vivo proof-of-concept studies in Q4
Morphomer NLRP3-ASC: report in vivo proof-of-concept results in a non-central nervous system (CNS) disease model and begin in vivo proof-of-concept studies with validated candidate in central nervous system in Q4
Anti-NLRP3-ASC antibody: begin in vivo proof-of-concept studies in Q4
Anti-TDP-43 antibody: initiate IND-enabling toxicology studies in Q4
TDP-43 biofluid diagnostic: establish validation-ready assay in Q4
Analysis of Financial Statements for the quarter ended September 30, 2021
Cash Position: The Company had a total cash balance of CHF 188.6 million, composed of CHF 93.6 million in cash and cash equivalents and CHF 95.0 million in short-term financial assets. This compares to a total cash balance of CHF 225.9 million as of December 31, 2020. The Company’s cash balance provides enough capital resources to progress through at least Q1 2024 without consideration of potential incoming milestone payments.
Contract Revenues: The Company did not record contract revenues for the three months ended September 30, 2021, a decrease of CHF 1.1 million from the comparable period in 2020. The overall decrease is predominantly related to CHF 1.1 million of contract revenue associated with R&D activities in our agreement with Lilly that were recognized in 2020 and did not repeat in the current period.
R&D Expenditures: R&D expenses decreased by CHF 0.4 million for the three months ended September 30, 2021, to CHF 15.1 million.
Discovery and preclinical expenses (-1.7 million): The Company decreased expenditures across a variety of its discovery and preclinical programs. This was predominantly led by a decrease in investment for the research of alpha-synuclein antibodies and other discovery programs.
Clinical expenses (+0.6 million): The Company increased expenditures across multiple clinical programs, predominantly for ACI-35-030 driven by R&D cost sharing and increased patient enrollments into the Phase 1b/2a study. This increase was offset as the Company incurred less expense for ACI-24 for AD as the prior six-month safety period completed.
Salary- and benefit-related costs (+0.5 million): The Company’s salary- and benefit-related costs increased primarily due to the internal reallocation of certain employees’ salaries and the annualization of 2020 hires.
G&A Expenditures: For the three months ended September 30, 2021, G&A increased by CHF 0.5 million to CHF 5.4 million. This increase is predominantly related to transaction costs incurred to complete the asset acquisition for Affiris’ alpha-synuclein portfolio as well as other administrative items.
Other Operating Income: The Company recognized CHF 0.3 million in grant income for R&D activities performed under our Michael J. Fox Foundation for Parkinson’s Research (MJFF) and Target ALS grants, a decrease of CHF 0.2 million compared to the prior period.
IFRS Loss for the Period: The Company reported a net loss after taxes of CHF 15.9 million for the three months ended September 30, 2021, compared with a net loss of CHF 19.0 million for the comparable period in 2020.