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SEC Filings

20-F
AC IMMUNE SA filed this Form 20-F on 03/21/2019
Entire Document
 

 

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.

 

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

 

None.

 

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.

 

A.Operating results

 

Overview

 

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.

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© AC Immune 2015