We are also using our Morphomer platform
to develop complementary diagnostic products such as positron emission tomography, or PET, ligands, which are tracers that can
directly measure misfolded Tau, alpha-synuclein and TDP-43 in the brain, to enable early and reliable disease diagnoses.
We use our two unique proprietary platform
technologies, SupraAntigen (conformation-specific biologics) and Morphomer (conformation-specific small molecules), to discover,
design and develop medicines and diagnostics to target misfolded proteins. These platforms are our engines for generating novel
molecules that are designed to bind to their targets with high affinity and conformational specificity, meaning they enabled differentiating
between misfolded proteins and normally-folded proteins. All of our product candidates and our development programs have been derived
from our proprietary platforms.
To date, we have primarily financed our
operations through the proceeds from our three follow on and initial public offerings, private placements of preferred securities
and upfront and milestone payments from our collaboration partners. We have no products approved for commercialization and have
never generated any revenues from product sales. Biopharmaceutical product development is a highly speculative undertaking and
involves a substantial degree of risk. It may be several years, if ever, before we or our collaboration partners complete pivotal
clinical studies and have a product candidate approved for commercialization and we begin to generate revenue and royalties from
product sales. Since our inception, we have received upfront and milestone payments from our collaboration partners and certain
other revenue. However, we have also incurred significant operating losses. For example, we incurred net losses of CHF 50.9 million
for the fiscal year ended December 31, 2018. In addition, we had accumulated losses of CHF 121.9 million as of December 31,
Strategic Collaborations and Licensing Agreements
Since our inception, we have entered into
strategic collaboration agreements with a range of partners covering a number of our product candidates. We entered into a strategic
collaboration with Genentech in November 2006 (as amended in May 2015) regarding the development, manufacture and commercialization
of crenezumab, and we refer to this agreement as the 2006 Genentech agreement. In June 2012, we entered into an additional strategic
collaboration agreement with Genentech regarding the development, manufacture and commercialization of anti-Tau antibodies, and
we refer to this agreement as the 2012 Genentech agreement. We expect to capitalize on Genentech’s drug development and regulatory
expertise and commercial capabilities to bring our partnered therapeutic products to market. In May 2014, we entered into a license
and collaboration agreement with Life Molecular Imaging (formerly Piramal Imaging SA) covering Tau-PET Imaging tracer. In December
2014 (and as amended in April 2016 and July 2017), we entered into a strategic collaboration agreement with Janssen regarding the
development, manufacture and commercialization of ACI-35, an anti-Tau vaccine. We expect to capitalize on Janssen and Johnson &
Johnson’s extensive regulatory expertise and experience in developing, manufacturing and, if approved, commercializing vaccines
to bring ACI-35 to market.
In April 2016, we entered into a non-exclusive
collaboration with Biogen covering our alpha-synuclein PET imaging tracer and future initiatives targeted at TDP-43 PET imaging
tracers, which is a protein that has been recently linked to neurodegeneration in diseases including AD, PD and amyotrophic lateral
sclerosis (commonly known as ALS or Lou Gehrig’s disease). This collaboration is expiring in April 2019. In May 2017, we
entered into a Research Project Agreement with Essex to develop a recombinant protein therapeutic candidate acting on a unique
neuroprotective mechanism for treatment of neurological diseases, such as Alzheimer’s disease and frontotemporal dementia.
Essex continues to provide joint research commitment as well as financial support to AC Immune for the pre-IND development of the
biological agent. As part of this agreement, the parties have agreed to an initial two year Research Plan, which intends to develop
a basic Fibroblast Growth Factor as a therapeutic for the treatment of neurodegenerative diseases and to generate novel antibody
In December 2018, we entered into a license
agreement with Lilly to research and develop Tau Morphomer small molecules for the treatment of Alzheimer’s disease and
other neurodegenerative diseases. Under the terms of this agreement, we will conduct the development of Tau Morphomer small molecules
through the completion of Phase 1, starting in the second quarter of 2019. Lilly will fund and lead further clinical development
and will retain global commercialization rights for all indications, including Alzheimer’s disease and other neurodegenerative
diseases. The agreement became effective when the requirements of the Hart–Scott–Rodino Antitrust Improvements Act
of 1976 were satisfied subsequent to the year end, on January 23, 2019.
We have two partnership agreements with
Genentech, a company with a reputation for scientific excellence and a history of bringing innovative protein therapeutics to market.