|D.||Property, plant and equipment
The Company’s capital expenditures
were CHF 1.9 million in 2018 with CHF 1.4 million for lab equipment and leasehold improvements. These investments are to enhance
our research facilities.
We lease approximately 22,700 square feet
of space at the Innovation Park of the EPFL (École Polytechnique Fédérale Lausanne), Switzerland as of December
31, 2018. This property serves as our corporate headquarters, our research facility and laboratories. We believe that using the
EPFL facilities instead of building our own infrastructure helps us to maximize the value of our research and development capital
and make efficient use of our funds as we continue to build and develop our pipeline. We believe that the space of our existing
facilities is sufficient to meet our current needs.
ITEM 4A. UNRESOLVED STAFF COMMENTS
ITEM 5. OPERATING AND FINANCIAL REVIEW AND PROSPECTS
You should read the following discussion
and analysis of our financial condition and results of operations together with the information under “Item 3. Key Information—A.
Selected Financial Data” and our audited financial statements, including the notes thereto, included in this Annual Report.
The following discussion is based on our financial information prepared in accordance with IFRS as issued by the IASB, which might
differ in material respects from generally accepted accounting principles in other jurisdictions. The following discussion includes
forward-looking statements that involve risks, uncertainties and assumptions. Our actual results may differ materially from those
anticipated in these forward-looking statements as a result of many factors, including but not limited to those described under
“Item 3. Key Information—D. Risk Factors” and elsewhere in this Annual Report.
We are a clinical stage biopharmaceutical
company leveraging our two proprietary technology platforms to discover, design and develop novel, proprietary medicines for prevention,
diagnosis and treatment of neurodegenerative diseases associated with protein misfolding. Our SupraAntigen platform focuses on
vaccines and antibodies specific to disease causing conformations. Currently, an anti-Tau monoclonal antibody candidate is being
developed under a collaboration agreement with Genentech. A Phase 2 clinical study in prodromal-to-mild AD patients commenced in
the fourth quarter of 2017. Crenezumab a humanized, monoclonal, conformation-specific anti-Abeta antibody that we developed using
our proprietary SupraAntigen platform had the CREAD 1 and CREAD 2 Phase III studies in people with prodromal to mild sporadic Alzheimer’s
disease (AD) discontinued in January 2019. However, the Phase 2 development of crenezumab continues in a preventive trial of cognitively
healthy individuals in Colombia with a risk of developing AD.
Two of our other clinical product candidates,
ACI-24 and ACI-35, are being developed using our SupraAntigen platform and target AD through active immunization, where the immune
system is stimulated to make its own antibodies against pathological proteins:
ACI-24 is our wholly-owned anti-Abeta vaccine candidate which
recently completed its Phase 1/2 study. Due to the clean safety profile and potential dose dependent reduction of Abeta plaques
as measured by PET imaging, ACI-24 has been moved forward into a Phase 2 study. The main objectives of the trial are to assess
the safety, tolerability, immunogenicity and target engagement of ACI-24 formulations using intramuscular injections and analyze
ACI-24’s efficiency to reduce Abeta plaques in a larger cohort size. The Phase 2 study has started with the first patient
randomized in October 2018.
||ACI-35 is an anti-Tau vaccine candidate that we are developing under a collaboration agreement with Janssen. The Phase 1b study has been completed. AC Immune and Janssen have jointly decided to advance the anti-Tau vaccine program into further development. The elaboration of the development plan is under preparation. In a scientific advisory meeting, the UK regulatory authority, MHRA, were supportive of a shortened pre-clinical development of new second generation anti-Tau vaccines. These promising second generation vaccines are intended to be tested in the next Phase 1b/2a clinical study. |