Full Press Release Details
Lausanne, 31 May 2019
the Ordinary Shareholders' Meeting
| Date: | 28 June 2019, at 11:30 am Swiss time |
| Place: | Rosa Parks Learning Center, ACI offices, EPFL Innovation Park, Building G, South, 1st Floor, 1015 Lausanne |
In 2018, AC Immune continued to shape the
future by discovering and developing breakthrough therapies to treat neurodegenerative diseases, one of the most important societal
challenges of our day, through pioneering science and precision medicine. Specifically, our two validated proprietary discovery
platforms, SupraAntigen and Morphomer , already have and are continuing to produce value-creating innovative potential
therapeutics and diagnostics for neurodegenerative diseases.
AC Immune's partnerships with global
leaders in neurodegeneration, Eli Lilly, Genentech (a Roche company) and Janssen, have generated close to CHF300 million in funds
and are a testament to our approach. Our cash position, CHF300 million as of 31 March 2019, funds the company through Q3 2023,
allowing us to achieve multiple potentially transformative goals, even as we accelerate implementation of our strategy to new high
value therapeutic targets, like neuroinflammation.
We are glad to report that our strategy
and ongoing development programs closely match the evolving views of key opinion leaders. The recent setbacks in Abeta development,
including the discontinuation by our partner Roche of the Phase 3 crenezumab program, were very disappointing. Viewed positively
and taken together with other recent scientific findings, these events served to further elucidate the roadmap for developing effective
therapies and diagnostics to treat Alzheimer's disease (AD) and other neurodegenerative diseases.
We are already implementing the new strategies
recommended by KOLs going forward: 1) pursue Abeta in earlier-stage patients to prevent rather than treating AD and; 2) target
Tau, which has been shown to correlate with disease progression; 3) run trials of Abeta therapeutics in more homogeneous populations
(e.g. in our case, Down syndrome1 and familial AD2; 4) pursue combination therapies; 5) pursue neuroinflammation.
To succeed with the above, it is necessary to develop/access and utilize novel diagnostics allowing earlier treatment and more
specific identification of patients' pathologies applying Precision Medicine to neurodegenerative diseases
In the short- to medium-term, we and others
in the industry are increasingly focused on clinical trials of Tau therapies to treat early and late stage AD based on emerging
clinical evidence that Tau pathology drives disease progression3,4. We are also actively pursuing other strategies,
such as targeting neuroinflammation5,6, and look forward to communicating specifics on this soon.
In addition, we are targeting earlier therapeutic
intervention and prevention, for example by testing new diagnostic tools in the clinic that will allow us to identify and track
patients earlier and throughout the course of the disease. Effective diagnostics will allow us to detect and track specific pathologies,
making possible the study of combination therapies and prevention studies in pre-symptomatic patients, who could not otherwise
have been diagnosed.
Discovery platforms underpin pipeline
The AC Immune pipeline, all of which originated
from the SupraAntigenTM and MorphomerTM platforms, is broad and robust. It includes nine therapeutic and
three diagnostic product
| 1.Strydom A, et al., Alzheimers Dement (N Y) 2018; | 2.Lott IT and Head E.,Nat Rev Neurol. 2019 |
| 3. Pontecorvo MJ, et al., Brain 2019; | 4. Gordon BA, et al., Brain 2019 |
| 5. Heneka MT et al., Nat Rev Neurosci. 2018; | 6.Wang S et al., Int Immunopharmacol. 2019 |
candidates, with three product candidates
currently in four Phase 2 trials, as well as highly-valued preclinical assets targeting Tau, a-syn and TDP-43.
In December 2018, we initiated a transformative
license agreement with Lilly to research and develop small molecule Tau Morphomer aggregation inhibitors to treat AD and
other neurodegenerative diseases. The terms include upfront payment of CHF 80 million, USD 50 million convertible equity note,
CHF 60 million in potential near-term milestones, as well as additional potential milestones of approximately CHF 1.68 billion,
plus tiered royalty payments in the low double digits.
recruitment for a second Phase 2 trial of AC Immune's anti-Tau monoclonal antibody in moderate AD, supplementing a separate
Phase 2 trial to evaluate its efficacy and safety in participants with prodromal to mild AD. We expect data readout from the
Crenezumab continues to be studied in a
landmark trial of cognitively healthy individuals in Colombia with an autosomal dominant mutation who are at risk of developing
familial AD, under the Alzheimer's Prevention Initiative (API). The goal is to show that crenezumab will prevent or delay disease
onset and progression of AD, and continuing this study has been encouraged by KOLs since amyloid is still considered a critical
genetic and molecular pathology leading to the emergence of AD. The current prevailing view is that Abeta treatment was tested
too late in the course of the disease to have an impact and that Abeta monotherapy should be applied in primary or secondary prevention
studies as tested in the API study.
a Phase 2 clinical trial with an adaptive design for evaluation of ACI-24 (anti-Abeta vaccine) in patients with mild AD, and
completed recruitment of the ACI-24 Phase 1b study for the treatment of AD-like characteristics in adults with Down syndrome.
We expect interim data in 2019 and a potential decision to start Phase 2 ahead of plan.
There are several other milestones approaching
in 2019, including lead selection of a-synuclein and TDP-43 antibodies and proof-of-concept of the first candidate targeting neuroinflammation.
The Morphomer Tau Phase 1 study by Lilly is expected to start in Q2 2019, and Phase 2 testing of ACI-35 is anticipated to
Management Appointments
On the personnel front, we strengthened
the executive management team with the appointments of Dr. Marie Kosco-Vilbois, as Chief Scientific Officer, with a strong background
in immunology and inflammation. We also appointed Piergiorgio Donati as Head of Technical Operations and Program Management and
Dr. Sonia Poli as Head of Translational Science.
The achievements of AC Immune - not
just in 2018 but looking back to the foundation of the company more than 15 years ago - have been enabled by the commitment
and support of you, our highly valued shareholders. We would like to take this opportunity to extend our gratitude for your continued
interest and engagement in our work in such an exciting and challenging field, which is one of the greatest unmet medical needs
as well as one of the biggest opportunities in healthcare. We always appreciate your different and sometimes challenging insights
and feedback, all of which contribute to our growth and success, and we look forward to keeping you up to date on the exciting
developments ahead of us in 2019.
Together, we can look forward to taking
AC Immune forward to developing innovative treatments and diagnostics that shape how we address neurodegenerative diseases.
| Martin Velasco | Prof. Andrea Pfeifer |
| Chairman of the Board | CEO |
Kindly find hereafter the agenda items and
proposals of the Board of Directors in connection with the third ordinary annual meeting of AC Immune SA as a public company:
Agenda Items and Proposals of the Board
The Board proposes to approve
the Annual Report, the Annual Statutory Financial Statements and the Financial Statements under IFRS of AC Immune SA for the year
2018, and to take note of the Reports of the Auditors. Copies of these documents are available for download in the "Investors"
section of our website (www.acimmune.com).
The Board of Directors proposes
that the net loss of the year 2018 in the amount of KCHF 48'894 is added to the loss brought forward of KCHF 58'426 resulting
in a new balance of loss brought forward of KCHF 107'320. Under IFRS accounting principles, the net loss for the business
year 2018 amounted to KCHF 50'951.
The Board proposes that the
members of the Board and the Executive Committee are discharged from their liabilities for their activities in the financial year
The Board of Directors proposes
to hold the following separate votes on the non-performance-related and the variable compensation of the Board of Directors (size
unchanged) and the Executive Committee (size increased from four persons in the previous year to six persons in the current year):
The Board of Directors proposes
that shareholders approve the total maximum amount of non-performance-related compensation for the members of the Board of Directors
covering the period from 1 July 2019 to 30 June 2020, i.e., CHF 547'000 (cash base compensation plus
social security costs).
The Board of Directors proposes
that shareholders approve the maximum grant of equity or equity linked instruments for the members of the Board of Directors from
1 July 2019 to 30 June 2020 with maximum value of CHF 626'000 (equity or equity linked instruments value plus social
The Board of Directors proposes
that shareholders approve the total maximum amount of non-performance-related cash compensation for the members of the Executive