On April 28, 2023 AC Immune SA (NASDAQ: ACIU), a clinical-stage biopharmaceutical company pioneering precision medicine for neurodegenerative diseases, reported results for the first quarter ended March 31, 2023, and provided a corporate update (Press release, AC Immune, APR 28, 2023, View Source [SID1234630690]).
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Dr. Andrea Pfeifer, CEO of AC Immune SA, commented: "Recent accomplishments reaffirm our industry-leading position in developing vaccines and diagnostics for neurodegenerative diseases supporting the transition to targeted treatment and disease prevention. Our maturing pipeline’s substantial breadth offers multiple milestones in the near- and mid-term and we have the strong cash position needed to deliver them."
"We are delighted to see our Tau positron emission tomography (PET) tracer PI-2620 progress into the pivotal Phase 3 ADvance trial, with our partner, LMI. Similarly, we are excited by the initial positive data from the Phase 1b/2 ABATE trial of ACI-24.060 and the expansion as planned, to include individuals with Down syndrome. The trial is now advancing towards additional interim safety and immunogenicity data in both indications this year, as well as PET imaging analyses in H1 2024 that will evaluate ACI-24.060’s impact on amyloid plaques. With amyloid PET increasingly recognized as a surrogate marker of efficacy in AD, these analyses represent a significant potential de-risking event that could rapidly propel our wholly-owned vaccine towards a pivotal program."
Q1 2023 and Subsequent Highlights
ACI-24.060 positive initial interim safety and immunogenicity data were reported from the first, low dose Alzheimer’s disease (AD) cohort of the Phase 1b/2 ABATE trial of AC Immune’s wholly-owned anti-Abeta SupraAntigen vaccine candidate.
Initial interim ABATE data triggered the planned trial expansion to include individuals with Down syndrome (DS) and the initiation of evaluation of higher doses of ACI-24.060 in AD.
Interim safety and immunogenicity data from ABATE’s AD and DS cohorts are expected in the second half of 2023.
The first participant was imaged in the pivotal Phase 3 ADvance trial evaluating the Morphomer derived Tau-PET tracer, PI-2620, in AD. PI-2620 is being developed as part of a research collaboration between AC Immune and Life Molecular Imaging.
AC Immune’s therapeutic and diagnostic programs were featured in 10 presentations at the International Conference on Alzheimer’s & Parkinson’s Diseases (AD/PD 2023), highlighting the breadth of the company’s pipeline as well as its differentiated Precision Medicine approach to addressing neurodegenerative disease.
New grants that collectively provide more than USD 500,000 in additional non-dilutive capital to support the advancement of diagnostic programs targeting TDP-43 (TAR DNA-binding protein 43) were awarded to AC Immune by The Michael J. Fox Foundation for Parkinson’s Research (MJFF) and the Target ALS Foundation.
Our webinar "Early Diagnosis and Prevention of Alzheimer’s Disease" featured presentations by invited Key Opinion 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 view a replay of the webinar, click here.
Anticipated 2023 Milestones
ACI-24.060
anti-Abeta vaccine
Submission of an Investigational New Drug (IND) application to enable expansion of ABATE study to the U.S. expected in H1 2023
Additional interim safety and immunogenicity data from AD cohorts of ABATE study expected in H2 2023
Interim safety and immunogenicity data from DS cohort of ABATE study expected in H2 2023
ACI-7104.056
anti-a-syn vaccine
Update from Phase 2 VACSYN study in Parkinson’s disease expected in H2 2023
ACI-35.030
anti-pTau vaccine
Initiation of next trial in AD expected in H2 2023 (to be followed by milestone payment)
Semorinemab
anti-Tau antibody
Results from the open-label extension of the Phase 2 Lauriet trial in mild-to-moderate AD expected in H2 2023
Anti-TDP-43 antibody
Advancement of candidate into preclinical development (tox) expected in H2 2023
a-syn-PET tracer
Declaration of next clinical candidate for development in Parkinson’s disease expected in H2 2023
TDP-43-PET tracer
Clinical candidate declaration expected in H1 2023
Analysis of financial statements for the quarter ended March 31, 2023
Cash position: The Company had a total cash balance of CHF 105.4 million (CHF 122.6 million as of December 31, 2022), composed of CHF 57.4 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 at least Q3 2024 without considering receiving potential future milestone payments.
R&D expenditures: R&D expenses in the period were CHF 13.9 million, compared with CHF 15.1 million for the comparable period in 2022, mainly driven by lower discovery and preclinical expenses.
Other operating income: The Company recognized CHF 0.4 million in grant income from Michael J. Fox Foundation and Target ALS.
IFRS loss for the period: The Company reported a net loss after taxes of CHF 17.5 million for the three months ended March 31, 2023, compared with a net loss of CHF 18.8 million for the comparable period in 2022.
2023 Financial guidance
Total cash burn guidance for the full year 2023 remains unchanged ranging from CHF 65 to CHF 75 million. The Company defines cash burn as operating expenditures adjusted to include capital expenditures and offset by significant non-cash items (including share-based compensation and depreciation expense).