Full Press Release Details
AC Immune Receives Second Milestone and
New Milestone to Increase the Potential Deal Value of Lilly Morphomer Tau Partnership
Lausanne, Switzerland, March 23, 2020
- AC Immune SA (NASDAQ: ACIU), a Swiss-based, clinical-stage biopharmaceutical
company, today announced that it will receive a second milestone payment of CHF 10 million
from Eli Lilly and Company on or before March
31, 2020 related to development progress in the small molecule Morphomer Tau aggregation inhibitor program.
The multi-year collaboration agreement
between Lilly and AC Immune was originally announced in December 2018 and focuses on the
broad development of Morphomer Tau aggregation inhibitors for Alzheimer's disease (AD) and other neurodegenerative
The second milestone payment of CHF 10
million marks significant progress between the companies in just 15 months. In that time, ACI-3024, a first-in-class investigational
oral small molecule Tau Morphomer for treatment of Alzheimer's disease (AD) and other neurodegenerative disorders,
has advanced from preclinical into Phase 1 clinical development. Lilly made a first milestone payment
of CHF 30 million in September 2019.
Under the updated collaboration terms, AC
Immune will now also be eligible for a new CHF 60 million potential milestone after initiation of Tau Morphomer Phase 2
clinical testing. No additional changes were made to other later-stage milestones or royalty terms.
Prof. Andrea Pfeifer, CEO of AC Immune
SA, commented: "This new Phase 2 milestone was not included previously in the agreement and its addition increases the
total deal value and offers a new significant potential source of medium-term non-dilutive financing. This reflects the progress
achieved in this transformative partnership with Lilly, who is an industry leader in Alzheimer's research, and our confidence
in the partnership's potential to make a major contribution to treating this devastating disease and to create shareholder
Tau is a high priority therapeutic target
in the complex treatment paradigm for AD and ACI-3024 is the most advanced orally available small molecule therapeutic candidate
of its kind in development. ACI-3024's proposed unique mechanism of action targets both intracellular and extracellular Tau
aggregates, potentially slowing or stopping the accumulation and propagation of pathological Tau aggregates in AD patients. Compared
to other Tau-targeting molecules in development, the key potential differentiating factor is that ACI-3024 has been shown to act
intracellularly to address specifically Tau pathology at an early stage.
ACI-3024 is the lead molecule, discovered
by AC Immune and being developed within the license and collaboration agreement between AC Immune and Lilly to research and develop
small molecule Tau Morphomer aggregation inhibitors for the treatment of AD and other neurodegenerative diseases. The collaboration
combines AC Immune's proprietary Morphomer discovery platform technology and early development experience with Lilly's
established clinical development expertise and commercial capabilities in central nervous system disorders. Under the agreement
AC Immune is conducting the initial Phase 1 development of ACI-3024 while Lilly will fund and conduct further clinical development.
1 trial initiated in July 2019 is a randomized, placebo-controlled, double-blind, sequential single and multiple
ascending dose study that aims to assess the safety, tolerability, pharmacokinetics, and pharmacodynamics of ACI-3024 in healthy
volunteers. Data from the study may be communicated as soon as the second half of 2020, at the discretion of Lilly.
AC Immune and Eli Lilly and Company Agreement
Under the terms of the agreement, initially
signed in December 2018, Lilly received worldwide commercialization rights for Tau aggregation inhibitors for Alzheimer's
disease and other neurodegenerative diseases. AC Immune received an upfront payment of CHF 80 million as well as $50 million in
exchange for a note, convertible to equity at a premium. AC Immune is now eligible to receive other development, regulatory and
commercial milestones, up to approximately CHF 1.8 billion, and tiered royalty payments in the low double digits. The initial CHF
60 million milestone payment has been modified such that Lilly has paid AC Immune CHF 30 million during Q3 2019 and CHF 10 million
in Q1 2020, instead of CHF 30 million; and, AC Immune now is eligible for a new additional milestone payment of CHF 60 million
within 60 days after dosing of the first patient in the first Phase 2 clinical trial of a Tau Morphomer in the United States
or European Union. The amendment to the financial terms increases the total deal value by CHF 40 million to CHF 1.86 billion, up
from CHF 1.82 billion.
Immune SA is a Nasdaq-listed clinical-stage biopharmaceutical company, which aims to become a global leader in precision medicine
for neurodegenerative diseases. The Company utilizes two proprietary platforms, SupraAntigenTM and MorphomerTM,
to design, discover and develop small molecule and biological therapeutics as well as diagnostic products intended to diagnose,
prevent and modify neurodegenerative diseases caused by misfolding proteins. The Company's pipeline features nine therapeutic and
three diagnostic product candidates, with six currently in clinical trials. It has collaborations with major pharmaceutical companies
including Lilly, Roche/Genentech, and Janssen Pharmaceuticals.
For further information, please contact:
| Head of Investor Relations Joshua Drumm AC Immune Phone: +1 917 809 0814 Email: joshua.drumm@acimmune.com | US Media Katie Gallagher LaVoieHealthScience Phone: +1 617 792 3937 Email: kgallagher@lavoiehealthscience.com |
| Global Head of Communications Judith Moore AC Immune Phone: +41 79 826 63 82 Email: judith.moore@acimmune.com | European Investors & Media Chris Maggos LifeSci Advisors Phone: +41 79 367 6254 Email: chris@lifesciadvisors.com |
Forward looking statements
This press release contains statements that
constitute "forward-looking statements" within the meaning of Section 27A of the Securities Act of 1933 and Section
21E of the Securities Exchange Act of 1934. Forward-looking statements are statements other than historical fact and may include
statements that address future operating, financial or business performance or AC Immune's strategies or expectations. In
some cases, you can identify these statements by forward-looking words such as "may," "might," "will,"
"should," "expects," "plans," "anticipates," "believes," "estimates,"
"predicts," "projects," "potential," "outlook" or "continue," and other
comparable terminology. Forward-looking statements are based on management's current expectations and beliefs and involve
significant risks and uncertainties that could cause actual results, developments and business decisions to differ materially from
those contemplated by these statements. These risks and uncertainties include those described under the captions "Item 3.
Key Information - Risk Factors" and "Item 5. Operating and Financial Review and Prospects" in AC Immune's
Annual Report on Form 20-F and other filings with the Securities and Exchange Commission. Forward-looking statements speak only
as of the date they are made, and AC Immune does not undertake any obligation to update them in light of new information, future
developments or otherwise, except as may be required under applicable law. All forward-looking statements are qualified in their
entirety by this cautionary statement.