UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 6-K
REPORT OF FOREIGN PRIVATE ISSUER PURSUANT TO RULE 13a-16 OR 15d-16 UNDER THE SECURITIES EXCHANGE ACT OF 1934
For the month of June, 2019
Commission File Number: 001-37891
AC IMMUNE SA
(Exact name of registrant as specified in its charter)
EPFL Innovation Park
Building B
1015 Lausanne, Switzerland
(Address of principal executive office)
Indicate by check mark whether the registrant files or will file annual reports under cover of Form 20-F or Form 40-F:
| Form 20-F | X |
Form 40-F |
Indicate by check mark if the registrant is submitting the Form 6-K in paper as permitted by Regulation S-T Rule 101(b)(1):
| Yes | No | X |
Indicate by check mark if the registrant is submitting the Form 6-K in paper as permitted by Regulation S-T Rule 101(b)(7):
| Yes | No | X |
Annual Ordinary Shareholders’ Meeting Results
On June 28, 2019, AC Immune SA (“AC Immune”) held its annual Ordinary Shareholders’ Meeting. The presentation that was given at the Ordinary Shareholders’ Meeting is attached hereto as Exhibit 99.1 and the press release relating to the results of the Ordinary Shareholders’ Meeting is attached hereto as Exhibit 99.2. Prior to the meeting, the Board withdrew agenda items 9 and 10. The final results of each of the agenda items submitted to a vote of the shareholders are as follows:
Agenda Item 1: Approval of the Annual Report, Annual Statutory Financial Statements and Financial Statements under IFRS of AC Immune SA for the year 2018
AC Immune shareholders approved the Annual Report, the Annual Statutory Financial Statements and the Financial Statements under IFRS of AC Immune SA for the year 2018, and took note of the Reports of the Auditors.
Agenda Item 2: Appropriation of Loss
AC Immune shareholders approved the addition of the net loss for the year 2018 in the amount of KCHF 48,894 to the loss brought forward of KCHF 58,426, resulting in a new balance of loss brought forward of KCHF 107,320.
Agenda Item 3: Discharge of the Members of the Board of Directors and the Executive Committee
AC Immune shareholders approved the discharge of the Board and the Executive Committee of their liabilities for their activities in the financial year 2018.
Agenda Item 4: Compensation for the Members of the Board of Directors and the Executive Committee
AC Immune shareholders approved:
| A. | 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); |
| B. | 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 security costs); |
| C. | The total maximum amount of non-performance-related cash compensation for the members of the Executive Committee from 1 July 2019 to 30 June 2020, i.e., CHF 2,407,000 (cash base compensation plus social security costs); |
| D. | The total maximum amount of variable compensation for the members of the Executive Committee for the current year 2019, i.e., CHF 1,195,000 (cash compensation plus social security costs); and |
| E. | The maximum grant of equity or equity linked instruments for the members of the Executive Committee from 1 July 2019 to 30 June 2020 with maximum value of CHF 3,126,000 (equity or equity linked instruments value plus social security costs). |
Agenda Item 5: Election of the Members of the Board
AC Immune shareholders approved the re-election of Douglas Williams as member and as election as Chairman of the Board, the re-election of Martin Velasco as member and election as Vice-Chairman of the Board, the re-election of Peter Bollmann, Friedrich von Bohlen, Andrea Pfeifer, Tom Graney and Werner Lanthaler and the election of Roy Twyman as members of the Board of Directors, each until the end of the next Ordinary General Meeting.
Agenda Item 6: Election to the Compensation, Nomination & Corporate Governance Committee
AC Immune shareholders approved the re-election of Martin Velasco, Tom Graney and Douglas Williams as members of the Compensation, Nomination & Corporate Governance Committee, each until the end of the next Ordinary General Meeting.
Agenda Item 7: Election of the Independent Proxy
AC Immune shareholders approved the election of Reymond & Associés, represented by Denis Cherpillod as AC Immune’s independent proxy until the end of the next Ordinary General Meeting.
Agenda Item 8: Re-Election of the Auditors
AC Immune shareholders approved the re-election of PricewaterhouseCoopers SA, in Pully, for a term of office of one year.
Agenda Item 11: Conditional Capital Increase for Employee Benefit Plans
AC Immune shareholders approved an amendment to the existing first paragraph of article 3c (Conditional Capital Increase for Employee Benefit Plans) of the articles of association pertaining to the conditional capital increase for employees and individuals of comparable positions, to create conditional share capital for the same purpose in the maximum amount of CHF 70,460 by the issuance of 3,523,000 registered common shares of CHF 0.02 nominal value each and to amend article 3c, paragraph 1 of the articles of association thereby increasing the conditional capital in the amount of 27,069.90 representing 1,353,495 registered common shares of CHF 0.02 nominal value each.
SIGNATURE
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned, thereunto duly authorized.
| AC IMMUNE SA | |||||
| By: | /s/ Andrea Pfeifer | ||||
| Name: | Andrea Pfeifer | ||||
| Title: | Chief Executive Officer | ||||
| By: | /s/ Joerg Hornstein | ||||
| Name: | Joerg Hornstein | ||||
| Title: | Chief Financial Officer | ||||
Date: June 28, 2019
EXHIBIT INDEX
Exhibit Number |
Description |
| 99.1 | Annual Ordinary Shareholders’ Meeting presentation |
| 99.2 | Press Release dated June 28, 2019 |
Exhibit 99.1
www.acimmune.com © 2019 AC Immune. Not to be used or reproduced without permission. Roadmap to successful therapies for neurodegenerative diseases NASDAQ: ACIU | Annual General Meeting | June 2019 Version June 28
© 2019 AC Immune. Not to be used or reproduced without permission. 2 NASDAQ: ACIU | Annual General Meeting | June 2019 ▪ AC Immune’s roadmap to successful therapies for neurodegenerative disease ▪ AC Immune’s revised business strategy ▪ Focus on more homogeneous Alzheimer’s disease populations ▪ Achievements 2018/19 ▪ Financial figures ▪ Strategic outlook Agenda
© 2019 AC Immune. Not to be used or reproduced without permission. 3 NASDAQ: ACIU | Annual General Meeting | June 2019 Disclaimer This presentation may contain 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. This presentation is strictly confidential, is being distributed to a limited range of invited persons solely for their own information, may not be distributed to the press or any other person, and may not be reproduced or published, in whole or in part, in any form.
AC Immune’s roadmap to successful therapies for neurodegenerative diseases Andrea Pfeifer, CEO
© 2019 AC Immune. Not to be used or reproduced without permission. 5 NASDAQ: ACIU | Annual General Meeting | June 2019 (1) Reardon S, Nature 2018 ; (2) Pontecorvo MJ, et al ., Brain 2019 ; (3) Gordon BA, et al., Brain 2019 ; (4) Strydom A, et al ., Alzheimers Dement (N Y) 2018 ; (5) Lott IT and Head E., Nat Rev Neurol . 2019 ; (6) Robinson JL, et al., Brain 2018 ; (7) Heneka MT et al ., Nat Rev Neurosci . 2018 ; (8) Wang S et al ., Int Immunopharmacol . 2019 ; (9) NOD) - like receptor protein 3; (10) Apoptosis - associated speck protein containing a CARD Precision medicine is a key driver for effective treatments ▪ Familial Alzheimer’s disease, Down syndrome ▪ NeuroOrphan indications ▪ Diagnose co - pathologies with selective diagnostics ▪ Select study population based on specific proteinopathies Treat earlier 1 More homogenous populations 4,5 Precision medicine 6 Target neuroinflammation 7,8 ▪ Prioritize primary and secondary prevention trials ▪ Access diagnostic tools for patient identification ▪ Develop m onoclonal antibodies and small molecules for microglial balance targeting the inflammasome NLRP3 9 - ASC 10 pathway Target Tau 2,3 ▪ Develop Tau and u se Tau PET tracers to diagnose/select patients Roadmap to successful therapies for neurodegenerative diseases
AC Immune’s revised business s trategy
© 2019 AC Immune. Not to be used or reproduced without permission. 7 NASDAQ: ACIU | Annual General Meeting | June 2019 Vision SupraAntigen TM Vaccines and antibodies specific to disease causing conformations Morphomer TM Conformation - sensitive small molecules To become a global leader in precision medicine 1 for neurodegenerative diseases leveraging dual proprietary technology platforms to develop breakthrough mono - and combination therapies (1) The goal of precision medicine is to deliver optimally targeted and timed interventions tailored to the individual disease drivers Dual Proprietary Technology Platforms Images: Hickman et a l, JBC 2011; Kroth et al , JBC 2012
© 2019 AC Immune. Not to be used or reproduced without permission. 8 NASDAQ: ACIU | Annual General Meeting | June 2019 Precision medicine enables combination therapies AC Immune is focused on detecting and treating AD 1 earlier (1) Alzheimer’s disease; (2) Mild cognitive impairment ▪ Future treatment paradigms for neurodegenerative diseases may involve different combinations of disease modifiers at various stages of disease ▪ Combination therapies may include anti - Abeta and anti - Tau immunotherapies or combinations of small and large molecules
© 2019 AC Immune. Not to be used or reproduced without permission. 9 NASDAQ: ACIU | Annual General Meeting | June 2019 ▪ Addressing largest market opportunity in healthcare ▪ Pioneering precision medicine in neurodegenerative diseases ▪ CHF 302 million in cash, supports operations through Q3 2023 1 ▪ Increasing investment into key areas of NeuroOrphan and neuroinflammation Company strengths Broad pipeline and solid financial position (1) As of Q1 2019. Expected cash runway, excluding potential incoming milestones. ▪ Broad pipeline with three candidates in Phase 2 ▪ Multiple near - term value inflection points ▪ Partnerships with Roche, Janssen and Eli Lilly ▪ Complementary diagnostics in clinical development ▪ Highly - valued preclinical assets in Tau, a - syn and TDP - 43 ▪ Highly productive validated discovery platforms for sustained growth to address misfolded proteins applicable across multiple diseases ▪ SupraAntigen : vaccines and antibodies specific to disease causing conformations ▪ Morphomer: conformation - sensitive small molecules 1 2 3 4 5
© 2019 AC Immune. Not to be used or reproduced without permission. 10 NASDAQ: ACIU | Annual General Meeting | June 2019 Investors and funds from partnerships Highly committed institutional investors 1 Five private financing rounds IPO NASDAQ September 2016 Share capital offering of 10 million common shares July 2018 Corporate funding to date 2 (in CHF millions ) Upfront payments Milestone payments 3 (1) Based on latest schedule 13G and 13F filings; (2) Converted to CHF based on exchange rates at times of receipt; (3) Not i ncl uding near - term $60m preclinical milestone payment from Lilly Tau agreement; (4) With Lilly convertible loan Convertible loan from Lilly ▪ CHF 312 million from investors ▪ CHF 292 million in partnering related funds 3,4 ▪ CHF 3.3 billion in total potential payments plus potential royalties
© 2019 AC Immune. Not to be used or reproduced without permission. 11 NASDAQ: ACIU | Annual General Meeting | June 2019 Precision medicine ultimately creates differentiation AC Immune’s strategy for successful AD treatment Vision Alzheimer’s disease (AD) Non - AD NeuroOrphans Diagnostics Technology platforms Values ▪ Develop best - in - class late stage assets in partnership ▪ Develop preventive/therapeutic vaccines as fully owned assets ▪ Establish a pipeline of disease modifying small molecules Alzheimer’s disease (AD) ▪ Discover therapeutics in Parkinson’s disease ▪ Leverage AD therapeutics in Down syndrome, PSP 1 and other NeuroOrphan diseases Non - AD, NeuroOrphans ▪ Accelerate diagnostic pipeline to late stage development ▪ Use diagnostics for improved clinical trials and external partnerships Diagnostics (1) Progressive supranuclear palsy
© 2019 AC Immune. Not to be used or reproduced without permission. 12 NASDAQ: ACIU | Annual General Meeting | June 2019 ACIU’s development in rare diseases US data Disease/Condition Incidence (per 100,000) Patient p opulation ('000) 2 AD Alzheimer's disease PD Parkinson's disease FTD Frontotemporal dementia ALS Amyotrophic lateral sclerosis LBD Dementia with Lewy bodies FTLD Frontotemporal lobar degeneration CAA 5 Cerebral amyloid angiopathy DS Down syndrome CBD Corticobasal degeneration NPD Niemann - Pick disease MD Myotonic dystrophy PSP Progressive supranuclear palsy CTEC 6 Chronic traumatic encephalopathy Dravet Paediatric refractory epilepsy 6 19 LBD a - synuclein PD Abeta CAA DS Tau PSP FTD CBD NPD ALS TDP - 43 FTLD Head injury (VA) AD DS MD CTEC ALS Market opportunity 17 79 6 1 - 13 4 1 4 15 3 160 1’500 7 - 42 5 - 400 55 19 3 - - - 255 - 1’300 30 - 500 5’000 (2) Calculated as incidence multiplied by US population 323m as of 2016 year end; (3) Patients aged between 45 - 64years; (4) Worl dwide incidence; (5) European incidence; (6) Estimated prevalence data unavailable; (7) Opportunity for pediatric Priority Review Voucher Orphan indication o pportunities ▪ Highlighted indications emerged as most relevant according to objective factors considering clinical development, the regulatory environment and manufacturing requirements
Pipeline and catalysts 2019/ 20
© 2019 AC Immune. Not to be used or reproduced without permission. 14 NASDAQ: ACIU | Annual General Meeting | June 2019 Driven by proprietary technology platforms for sustained growth TARGETS PRODUCT CANDIDATE INDICATION DISCOVERY PRECLIN PHASE 1 PHASE 2 PHASE 3 PARTNERS Tau Anti - Tau antibody AD 1 trt – prodromal mild AD trt - moderate ACI - 35 (anti - pTau vaccine ) AD treatment Abeta Crenezumab (anti - Abeta antibody) 2 AD prevention ACI - 24 (anti - Abeta vaccine) AD treatment AD trt in Down syndrome 3 a - synuclein Anti - a - syn antibody PD 4 , NeuroOrphan TDP - 43 Anti - TDP - 43 antibody NeuroOrphan Tau Morphomer Tau (Tau inhibitor, small molecule) AD treatment Tau - PET 5 tracer AD and PSP diagnostic Abeta Morphomer Abeta (Abeta inhibitor, small molecule) Glaucoma a - synuclein Morphomer a - syn (a - synuclein inhibitor, small molecule) PD, NeuroOrphan a - syn - PET tracer PD, a - synuclein pathologies TDP - 43 TDP - 43 - PET tracer diagnostic Broad and robust pipeline in neurodegenerative diseases (1) Alzheimer’s disease; (2) Prevention trial API - ADAD in Colombia; (3) AD and cognitive impairment associated with Down syndrome; (4) Parkinson’s disease (5) Positron emission tomography; (6) Progressive supranuclear palsy SupraAntigen TM Morphomer TM b iologics small molecules diagnostics
© 2019 AC Immune. Not to be used or reproduced without permission. 15 NASDAQ: ACIU | General Assembly | June 2019 Key milestones for 2019/ 20 Successful delivery of strategy with multiple near - term catalysts ACI - 24 ACI - 35 a - synuclein TDP - 43 a - synuclein PET tracer Morphomer Tau Phase 1b in DS preliminary interim data look (high dose cohort) Start Phase 1b/2a Preclinical POC 2 nd gen molecule starts FiM 4 Start Phase 1 SupraAntigen TM Morphomer TM b iologics small molecules diagnostics Preclinical POC Anti - Tau antibody S tart Phase 2 in moderate AD 1 ( 1) Alzheimer’s disease; (2) AD and cognitive impairment associated with Down syndrome; (3) Parkinson’s disease; (4) First in Man Neuroinflammation Preclinical POC AD 1 treatment AD 1 trt in Down syndrome 2 AD 1 treatment PD 3 and NeuroOrphan NeuroOrphan NeuroOrphan PD 3 , a - synuclein pathologies AD 1 treatment Anti - Tau antibody Readout Phase 2 in prodromal/ mild AD 1 AD 1 treatment
Focus on more homogeneous Alzheimer's disease populations
© 2019 AC Immune. Not to be used or reproduced without permission. 17 NASDAQ: ACIU | Annual General Meeting | June 2019 Tau and beta - amyloid are major hallmarks of neurodegeneration AD d evelops because of a complex series of events in the brain over a long period of time Genetics, lifestyle and environmental factors may contribute Diagnosed once symptoms present where irreversible loss of neurons has already occurred . What causes Alzheimer's disease (AD) ▪ The underlying pathology can be diverse ‒ to understand if a candidate drug has therapeutic potential it is important to apply in more homogeneous genetic populations
© 2019 AC Immune. Not to be used or reproduced without permission. 18 NASDAQ: ACIU | Annual General Meeting | June 2019 Two categories of genes influence whether a person develops AD Genetic populations APOE - e4 PSEN1 E280A mutation Down syndrome APOE - e4 gene Risk genes increase the likelihood of developing a disease, deterministic genes guarantee it ▪ 1 st risk gene identified ▪ 1 copy 2 – 3x risk of AD ▪ 2 copies 12x risk of AD ▪ 40‒65 % of people diagnosed with AD have 1 copy of the gene ▪ 20‒30% of us have the gene ▪ 90% lifetime risk of AD ▪ Prevalence increases to 55 % between 50 and 59 years, and 75 – 100 % in overs 60s ▪ Average age of diagnosis 55 years old ▪ Extra copy of chromosome 21 has gene for APP resulting in more Abeta ▪ 100% with mutation develop AD ▪ 5,000 members of an extended family in Antioquia, Colombia ▪ World's largest family in which a gene causes AD ▪ Average age of onset 44 years old ▪ No population wide screening ▪ AD cause multi - factorial ▪ Unique possibility to study prevention and treatment in defined genetic population ▪ Unique possibility to study prevention and treatment in defined genetic population ▪ World first clinical trial for vaccine targeting Abeta in people with Down syndrome ▪ First data for the landmark Alzheimer's Prevention Initiative (API) trial of crenezumab is expected early in 2022 ACIU’s clinical activity
© 2019 AC Immune. Not to be used or reproduced without permission. 19 NASDAQ: ACIU | Annual General Meeting | June 2019 Why study genetic populations Credit: Greg Kendall - Ball/Nature “ It has haunted me all of my life but I want to be prepared if possible Elenith is enrolled in a study of people whose families carry a genetic mutation for early - onset Alzheimer's disease “
© 2019 AC Immune. Not to be used or reproduced without permission. 20 NASDAQ: ACIU | Annual General Meeting | June 2019 Target Misfolded Abeta Licensee Key results ▪ Humanized IgG4 antibody 2,3 ▪ Designed to neutralize Abeta oligomers by 3 : ▪ Blocking the interaction of oligomers with neurons ▪ Promoting the phacocytic removal of oligomers by microglia ▪ Reduced risk of ARIA - E 1 and neuroinflammation allows for higher dosing Patient population ▪ Colombian family clan with Paisa mutation leading to Abeta accumulation and early onset AD 4 ▪ Largest autosomal - dominant AD 4 cohort ▪ Nearly 100% certainty of disease development due to a PSEN - 1 5 gene mutation ▪ Unique opportunity to study prevention and treatment in defined population Development status Phase 2 double - blind, placebo - controlled study ▪ Based on 300 asymptomatic, pre - MCI 6 subjects, of which 200 genetically predisposed to develop early AD ▪ Primary endpoint: composite cognitive test at week 260; s econdary endpoints: biomarkers, safety ▪ Started Dec 2013, study completion expected in Q1 2022 (1) Alzheimer’s Prevention Initiative – Autosomal - Dominant Alzheimer’s disease; (2) Adolfsson O, et al . J Neurosci . 2012;32:9677 – 9677; (3) Ultsch M, et al . Sci Rep . 2016; 6:39374; (4) Alzheimer’s disease; (5) Presenilin - 1 gene mutation; (6) Mild cognitive impairment Crenezumab Alzheimer prevention trial (API - ADAD 1 ) First - in - class anti - Abeta antibody in prevention trial
© 2019 AC Immune. Not to be used or reproduced without permission. 21 NASDAQ: ACIU | Annual General Meeting | June 2019 Target Misfolded Abeta Study rationale ▪ Down syndrome population is at high risk of developing AD ▪ 75 – 100% of people with Down syndrome have AD by age 60 ▪ Unique possibility to study prevention and treatment in defined genetic population Key results ▪ Compelling memory enhancement in ORT 1 in Down syndrome mouse model 2 Development status Clinical Phase 1b with interim data expected in Q2 2019 ▪ World first clinical trial for vaccine targeting Abeta in people with Down syndrome ▪ Dose escalation study in up to 24 adults with Down syndrome ( 25 - 45 years) ▪ Primary endpoints: safety and tolerability, anti - Abeta antibody titers and biomarkers; Secondary endpoint: clinical and cognitive measures ▪ Recruitment completed: low - dose cohort in Q3 2017 and high - dose cohort in Q2 2018 ACI - 24 – Phase 1b in Down syndrome (DS) Anti - Abeta therapeutic vaccine Belinchenko et a l PLOS ONE 2016 Reduction of Abeta levels in brain 2 Memory restoration 2 Down syndrome population is at high risk of developing AD ( 1 ) Object recognition test; (2) Reduction of Abeta levels in the brain of a DS relevant mouse model (TS65Dn) Alzheimer's Association, New York Muhs et a l PNAS 2007
Achievements 2018/19
© 2019 AC Immune. Not to be used or reproduced without permission. 23 NASDAQ: ACIU | Annual General Meeting | June 2019 Business Operations ▪ License agreement signed with Eli Lilly in December 2018 to research and develop Tau aggregation inhibitor small molecules for the potential treatment of Alzheimer’s disease and other neurodegenerative diseases ▪ Receipt of CHF 80 million upfront payment and USD 50 million convertible note ▪ Potential pre - clinical milestone of CHF 60 million planned for H2 2019 ▪ Substantially revised AC Immune’s equity story and business strategy after the crenezumab phase 3 discontinuation ▪ Awarded third follow - up grant from The Michael J. Fox Foundation for first - in - human study of a potential alpha - synuclein Positron Emission Tomography (PET) tracer for Parkinson's disease commenced in H1 of 2019 ▪ Established an exclusive strategic partnership with WuXi Biologics allowing ACIU to leverage WuXi’s manufacturing capabilities ▪ Appointed new Executive Management members: ▪ Dr. Marie Kosco - Vilbois, Chief Scientific Officer ▪ Mr. Piergiorgio Donati, Head of Technical Operations Program Management ▪ Dr . Sonia Poli, Head of Translational Science Highlights and achievements 2018/2019
© 2019 AC Immune. Not to be used or reproduced without permission. 24 NASDAQ: ACIU | Annual General Meeting | June 2019 Highlights and achievements 2018/2019 Finance ▪ Enhanced cash position CHF 302 million as of Q1 2019 ▪ R eceipt of CHF 80 million upfront payment and USD 50 million convertible note as a result of license agreement with Eli Lilly in December 2018 ▪ Convertible note automatically converted on April 25, 2019. 3.6m common shares were issued to Lilly at the predetermined price of $13.83 per share. This note is now fully settled and there is no further equity or cash consideration due to Lilly ▪ Follow - on offering of 10 million common shares in Q3 2018 which raised gross proceeds of USD 117.5 million (CHF 116.3 million ) ▪ Focused R&D investment of CHF 11.6 million in AD and future growth discovery programs, i.e. a - synuclein , TDP - 43 and neuroinflammation; additional strategic investments in our propriety and partnered vaccine programs, most notably ACI - 24 and ACI - 35 ▪ Strengthening our relationship with the investment community: ▪ Conducted 17 dedicated non - deal roadshows in the US and Europe ▪ Completed 206 individual investor presentations, with 42 meetings at JPM 2019 ▪ Hosted a Key Opinion Leader (KOL) event addressing Abeta oligomers in AD and other neurodegenerative diseases with top - level insights from KOLs Professor Michael W. Weiner 1 and Professor John Q. Trojanowsk 2 1(1)University of California San Francisco School of Medicine; (2) Perelman School of Medicine, University of Pennsylvania
© 2019 AC Immune. Not to be used or reproduced without permission. 25 NASDAQ: ACIU | Annual General Meeting | June 2019 Clinical stage programs Highlights and achievements 2018/19 Anti - Tau antibody 1 ▪ Commenced recruitment for a second Phase 2 trial of RG6100 (MTAAU9937A, RO7105705) in moderate AD (Q1 2019) ▪ The Phase 2 study in prodromal and mild AD which started in Q3 2017 was fully recruited in Q1 2019 . The primary completion data is planned for Q3 2020 Crenezumab 1 ▪ CREAD 1 and CREAD 2 Phase 3 studies discontinued (Q1 2019) ▪ The landmark Alzheimer's Prevention Initiative trial of crenezumab , for which data are expected in Q1 2022, is continuing in cognitively healthy individuals in Colombia with additional biomarker assessment in preclinical AD patients Anti - Abeta vaccine ACI - 24 in AD ▪ Commenced a Phase 2 clinical trial with an adaptive design (Q3 2018) ▪ Presented promising interim data of Phase1/2a (Q2 2019) at the Alzheimer's Association Workshop, Washington DC Anti - Abeta vaccine ACI - 24 in DS ▪ Completed recruitment for the high - dose cohort of Phase 1b study (Q2 2018) targeting Alzheimer's disease characteristics in individuals with Down syndrome, interim data look by Q2 2019 with the potential to start Phase 2 ahead of time (1) Developed under out - licensing agreements with Genentech/Roche
© 2019 AC Immune. Not to be used or reproduced without permission. 26 NASDAQ: ACIU | Annual General Meeting | June 2019 Clinical stage and Phase 1 ready programs Highlights and achievements 2018/19 Morphomer - a - synuclein - PET tracer ▪ The first - in - human trial for the potentially first selective alpha - synuclein Positron Emission T omography (PET) tracer has been initiated in Q1 2019 Anti - Tau vaccine ACI - 35 in AD ▪ Program is ready for initiation of Phase 1b/2a according to Company’s objectives Tau Morphomer in AD ▪ ACI - 3024 is ready for initiation of Phase 1 according to Company’s objectives Anti - a - synuclein antibody ▪ Proof of concept study available in Q3 2019 which will be the basis for the lead selection for humanization and further development Anti - TDP - 43 antibody ▪ Proof of concept study available in Q3 2019 which will be the basis for the lead selection for humanization and further development
© 2019 AC Immune. Not to be used or reproduced without permission. 27 NASDAQ: ACIU | Annual General Meeting | June 2019 Pre - clinical stage programs Highlights and achievements 2018/19 Morphomer neuroinflammation ▪ First NLRP3 small molecule inhibitors identified and further testing of analogues ongoing Morphomer TDP - 43 PET tracer ▪ Hit confirmation and optimization ongoing with multiple compounds
AC Immune: Finance Joerg Hornstein, CFO
© 2019 AC Immune. Not to be used or reproduced without permission. 29 NASDAQ: ACIU | General Assembly | June 2019 Key financial data 1 For the year ended December 31, 2018 2017 Change (in CHF million except per share data) Revenues 7.2 20.3 (13.1) R&D expenses (44.3) (32.7) (11.6) G&A expenses (12.5) (10.1) (2.4) IFRS loss for the period (50.9) (26.4) (24.5) IFRS EPS – basic and diluted (0.82) (0.46) (0.36) Non - IFRS loss for the period 1 (47.2) (20.6) (26.6) Non - IFRS EPS – basic and diluted 1 (0.76) (0.36) (0.40) As of December 31, 2018 2017 Change (in CHF million) Cash and cash equivalents 156.5 124.4 32.1 Short - term financial assets 30.0 - 30.0 Total Liquidity 2 186.5 124.4 62.1 Total shareholder’s equity 177.6 116.8 60.8 Financial overview [ 1] Non - IFRS (Loss) and Non - IFRS EPS are non - IFRS measures. [2] Liquidity is defined as the cash and cash equivalents plus short - term financial assets. These short - term financial assets are c omprised of cash held in fixed - term deposits ranging in maturity from 3−12 months
Strategic outlook
© 2019 AC Immune. Not to be used or reproduced without permission. 31 NASDAQ: ACIU | Annual General Meeting | June 2019 Strategy for value creation 3. INVEST to further build leadership in neurodegenerative diseases ▪ Execute in line with our “Roadmap” ▪ Focus on Tau and new targets in neuroinflammation 1.CONTINUE to focus on early treatment and prevention trials in homogeneous patient populations 4. DIVERSIFY into other neurodegenerative and NeuroOrphan diseases ▪ Potential for streamlined regulatory pathway ▪ Favorable pricing and reimbursement 2. EVOLVE strategy to focus on precision medicine and combination therapy approaches based on patients’ specific proteinopathies ▪ Leverage diagnostics portfolio to identify and track patients 5. CAPTURE maximum u pside by partnering assets at optimal point in development
© 2019 AC Immune. Not to be used or reproduced without permission. 32 NASDAQ: ACIU | Annual General Meeting | June 2019 We continue to shape the future of neurodegeneration by discovering and developing breakthrough therapies through pioneering science and precision medicine AC Immune
AGM Agenda Items and Proposals of the Board of Directors
© 2019 AC Immune. Not to be used or reproduced without permission. 34 NASDAQ: ACIU | Annual General Meeting | June 2019 Agenda 1. Approval of the Annual Report, Annual Statutory Financial Statements and Financial Statements under IFRS of AC Immune SA for the year 2018 2. Appropriation of Loss 3. Discharge of the Members of the Board of Directors and the Executive Committee 4. Compensation for the Members of the Board of Directors and the Executive Committee 5. Election of the Members of the Board 6. Election to the Compensation, Nomination & Corporate Governance Committee 7. Election of the Independent P roxy 8. Re - election of the Auditors 9. Authorized Share Capital 10. Conditional Capital Increase for Bonds and Similar Debt Instruments 11. Conditional Capital Increase for Employee Benefit Plans
© 2019 AC Immune. Not to be used or reproduced without permission. 35 NASDAQ: ACIU | Annual General Meeting | June 2019 Approval of the Annual Report, Annual Statutory Financial Statements and Financial Statements under IFRS of AC Immune SA for the year 2018 ▪ 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). Agenda item 1
© 2019 AC Immune. Not to be used or reproduced without permission. 36 NASDAQ: ACIU | Annual General Meeting | June 2019 Appropriation of Loss ▪ 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. Agenda item 2
© 2019 AC Immune. Not to be used or reproduced without permission. 37 NASDAQ: ACIU | Annual General Meeting | June 2019 Discharge of the Members of the Board of Directors and the Executive Committee ▪ 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 2018. Agenda item 3
© 2019 AC Immune. Not to be used or reproduced without permission. 38 NASDAQ: ACIU | Annual General Meeting | June 2019 Compensation for the Members of the Board of Directors and the Executive Committee ▪ 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 ): 4a. A Vote on Total Non - Performance - Related Compensation for Members of the Board of Directors from 1 July 2019 to 30 June 2020 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). Agenda item 4
© 2019 AC Immune. Not to be used or reproduced without permission. 39 NASDAQ: ACIU | Annual General Meeting | June 2019 Compensation for the Members of the Board of Directors and the Executive Committee ▪ 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 ): 4.b Vote on Equity for Members of the Board of Directors 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 security costs). Agenda item 4
© 2019 AC Immune. Not to be used or reproduced without permission. 40 NASDAQ: ACIU | Annual General Meeting | June 2019 Compensation for the Members of the Board of Directors and the Executive Committee ▪ 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 ): 4.c Vote on Total Non - Performance - Related Compensation for Members of the Executive Committee from 1 July 2019 to 30 June 2020 The Board of Directors proposes that shareholders approve the total maximum amount of non - performance - related cash compensation for the members of the Executive Committee from 1 July 2019 to 30 June 2020, i.e., CHF 2'407'000 (cash base compensation plus social security costs). Agenda item 4
© 2019 AC Immune. Not to be used or reproduced without permission. 41 NASDAQ: ACIU | Annual General Meeting | June 2019 Compensation for the Members of the Board of Directors and the Executive Committee ▪ 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 ): 4.d Vote on Total Variable Compensation for Members of the Executive Committee for the current year 2019 The Board of Directors proposes that shareholders approve the total maximum amount of variable compensation for the members of the Executive Committee for the current year 2019, i.e. , CHF 1'195'000 (cash compensation plus social security costs). Agenda item 4
© 2019 AC Immune. Not to be used or reproduced without permission. 42 NASDAQ: ACIU | Annual General Meeting | June 2019 Compensation for the Members of the Board of Directors and the Executive Committee ▪ 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 ): 4.e Vote on Equity for Members of the Executive Committee The Board of Directors proposes that shareholders approve the maximum grant of equity or equity linked instruments for the members of the Executive Committee from 1 July 2019 to 30 June 2020 with maximum value of CHF 3'126'000 (equity or equity linked instruments value plus social security costs). Agenda item 4
© 2019 AC Immune. Not to be used or reproduced without permission. 43 NASDAQ: ACIU | Annual General Meeting | June 2019 Election of the Members of the Board ▪ The Board of Directors proposes for a term until the end of the next ordinary General Meeting ▪ the re - election of Douglas Williams as member and election as Chairman of the Board, ▪ the re - election of Martin Velasco as member and election as Vice - Chairman of the Board, ▪ the re - election of Peter Bollmann , Friedrich von Bohlen, Andrea Pfeifer, Tom Graney and Werner Lanthaler and election of Roy Twyman as members of the Board of Directors ▪ Prof. Riesner has taken his retirement and will not stand for re - election. Agenda item 5
© 2019 AC Immune. Not to be used or reproduced without permission. 44 NASDAQ: ACIU | Annual General Meeting | June 2019 Election of the Members of the Board ▪ The Board of Directors proposes for a term until the end of the next ordinary General Meeting 5a. Re - election of Douglas Williams as member and election as Chairman of the Board of Directors 5.b Re - election of Martin Velasco as member and election as Vice - Chairman of the Board of Directors 5.c Re - election of Peter Bollmann 5.d Re - election of Friedrich von Bohlen 5.e Re - election of Andrea Pfeifer 5.f Re - election of Tom Graney 5.g Re - election of Werner Lanthaler 5.h Election of Roy Twyman Agenda item 5
Dr. Roy E. Twyman
© 2019 AC Immune. Not to be used or reproduced without permission. 46 NASDAQ: ACIU | Annual General Meeting | June 2019 ▪ CEO and founder, Amron Neuroscience, LLC ▪ Spent almost 20 years at Janssen Research & Development , LLC (a Johnson & Johnson company): ▪ M ember of the Neuroscience Therapeutic Area Leadership team responsible for clinical R&D and strategic planning of CNS neurology and psychiatry pipeline products . ▪ 2012 – 2018, Senior Vice President in the Neuroscience Therapeutic Area overseeing the Alzheimer’s Disease Area ▪ Independent board member and scientific advisory board member for a number of small biotech or pharmaceutical companies ▪ Academic training and appointments include: ▪ MD, University of Kentucky; Neurology Residency and Neurophysiology Fellowship, University of Michigan; Assistant Professor Department of Neurology, University of Michigan; Associate Professor with tenure in Departments of Neurology and Pharmacology & Toxicology; Huntsman Cancer Institute, Human Molecular Biology Eccles Institute of Genetics and Neuroscience Program appointments at University of Utah. Dr. Roy E. Twyman
© 2019 AC Immune. Not to be used or reproduced without permission. 47 NASDAQ: ACIU | Annual General Meeting | June 2019 Election to the Compensation, Nomination & Corporate Governance Committee ▪ The Board of Directors proposes the re - election of Martin Velasco, Tom Graney and Douglas Williams as members of the Compensation, Nomination & Corporate Governance Committee, each until the end of the next ordinary General Meeting 6.a Re - election of Tom Graney 6.b Re - election of Martin Velasco 6.c Re - election of Douglas Williams Agenda item 6
© 2019 AC Immune. Not to be used or reproduced without permission. 48 NASDAQ: ACIU | Annual General Meeting | June 2019 Election of the Independent P roxy ▪ The Board of Directors proposes to elect Reymond & Associés , represented by Denis Cherpillod , avocat , Avenue de la Gare 1, case postale 7255, 1002 Lausanne, as the independent proxy of the Company until the end of the next ordinary General Meeting Agenda item 7
© 2019 AC Immune. Not to be used or reproduced without permission. 49 NASDAQ: ACIU | Annual General Meeting | June 2019 Re - election of the Auditors ▪ The Board of Directors proposes to re - elect PricewaterhouseCoopers SA, in Pully , for a term of office of one year Agenda item 8
© 2019 AC Immune. Not to be used or reproduced without permission. 50 NASDAQ: ACIU | Annual General Meeting | June 2019 Authorized Share Capital ▪ Withdrawn by the Board of Directors Agenda item 9
© 2019 AC Immune. Not to be used or reproduced without permission. 51 NASDAQ: ACIU | Annual General Meeting | June 2019 Conditional Capital Increase for Bonds and Similar Debt Instruments ▪ Withdrawn by the Board of Directors Agenda item 10
© 2019 AC Immune. Not to be used or reproduced without permission. 52 NASDAQ: ACIU | Annual General Meeting | June 2019 Conditional Capital Increase for Employee Benefit Plans ▪ T he Board of Directors proposes to replace the existing first paragraph of article 3c (Conditional Capital Increase for Employee Benefit Plans) of the articles of association pertaining to the conditional capital increase for employees and individuals of comparable positions, to create conditional share capital for the same purpose in the maximum amount of CHF 70'460 by the issuance of 3'523'000 registered common shares of CHF 0.02 nominal value each and to amend article 3c, paragraph 1 of the articles of association as set out below: Agenda item 11 The share capital of the Company shall be increased by an amount not exceeding CHF 70'460 through the issue of a maximum of 3'523'000 registered shares, payable in full, each with a nominal value of CHF 0.02, in connection with the exercise of option rights granted to any employee of the Company or a subsidiary, and any consultant, members of the Board of Directors, or other person providing services to the Company or a subsidiary.
© 2019 AC Immune. Not to be used or reproduced without permission. 53 NASDAQ: ACIU | Annual General Meeting | June 2019 We thank you for coming and your continued support AC Immune
Exhibit 99.2
PRESS RELEASE
AC Immune Announces Election of New Chairman of the Board at Annual General Meeting
Lausanne, Switzerland, 28 June, 2019 – AC Immune SA (NASDAQ: ACIU), a Swiss-based, clinical-stage biopharmaceutical company with a broad pipeline focused on neurodegenerative diseases, announced that shareholders in the Company have elected Douglas Williams as Chairman of the Board at today’s Annual General Meeting (AGM).
At the AGM held in Lausanne, shareholders also elected Martin Velasco, previously Chairman, as Vice-Chairman of the Board. They re-elected Peter Bollmann, Friedrich von Bohlen, Andrea Pfeifer, Thomas Graney and Werner Lanthaler and elected Roy Twyman as members of the Board of Directors. Detlev Riesner has retired and did not stand for re-election.
Prof. Andrea Pfeifer, CEO of AC Immune, commented: “We are pleased to welcome Dr. Douglas Williams to the role of Chairman of the Board of AC Immune, to which he brings more than 30 years of experience and insight into the biotechnology industry. We’ve already benefitted from his leadership expertise as a member of our Board since 2018. In his career, Douglas has held senior executive roles at both pharmaceutical and biotechnology companies and played a role in the development of several novel drugs. The Board also welcomes Dr. Roy Twyman as a new member. Roy is an experienced neurologist who spent nearly 20 years at Janssen on its Neuroscience Therapeutic Area Leadership team where he oversaw clinical R&D and strategic planning for Alzheimer’s disease and other CNS disorders. Strengthening our Board of Directors with such accomplished industry leaders validates the strength and potential of our pipeline, and we believe their strategic guidance positions us for success as we continue to advance multiple clinical programs targeting neurodegenerative diseases.”
“We would also like to extend our deepest gratitude to Martin Velasco for his committed service as Chairman of the Board of AC Immune. We are honored by his dedication and delighted to continue benefitting from his knowledge and experience in his role as Vice-Chairman.”
Douglas E. Williams, Ph.D. Biography
Dr. Williams is currently the President, CEO and member of the Board of Directors of Codiak BioSciences. He was previously Biogen’s Executive Vice President, Research and Development. He joined Biogen from ZymoGenetics, where he was most recently CEO and member of the Board of Directors. Previously, he held leadership positions within the biotechnology industry, including Chief Scientific Officer and Executive Vice President of Research and Development at Seattle Genetics, and Senior Vice President and Washington Site Leader at Amgen. Dr. Williams served in a series of scientific and senior leadership positions over a decade at Immunex, including Executive Vice President and Chief Technology Officer and a member of the Board of Directors. During his 30+ year career in the biotechnology industry, he has played a role in the development of several novel drugs and has served on the board of numerous biotechnology companies.
Roy Twyman, M.D. Biography
Dr. Twyman is a neurologist and currently CEO and founder, Amron Neuroscience, LLC, a private consulting company focused on neuroscience drug development. Prior to this, Dr. Twyman spent almost 20 years at Janssen Research & Development, LLC (a Johnson & Johnson company) and was a member of the Neuroscience Therapeutic Area Leadership team responsible for clinical R&D and strategic planning of CNS neurology and psychiatry pipeline products. From 2012 to March 2018, he was a Senior Vice President in the Neuroscience Therapeutic Area overseeing the Alzheimer’s Disease Area. He currently participates as an independent board member or as a scientific advisory board member for a number of small biotech or pharmaceutical companies.
Shareholders also approved all resolutions at the AGM as proposed by the Board of Directors. Prior to the meeting, the Board withdrew agenda items 9 and 10.
About AC Immune SA
AC 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 is utilizing two proprietary discovery 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 five currently in clinical trials. It has collaborations with major pharmaceutical companies including Roche/Genentech, Eli Lilly and Janssen.
For further information, please contact:
US Investors Joshua Drumm, Ph.D. AC Immune Investor Relations Phone: +1 646 876 5538 E-mail: joshua.drumm@acimmune.com |
US Media Katie Gallagher or Sharon Correia LaVoieHealthScience Phone: +1 617 792 3937 E-mail: kgallagher@lavoiehealthscience.com scorreia@lavoiehealthscience.co |
European Media Judith Moore AC Immune Global Communication Lead Phone: +44 7932 053829 E-mail: judith.moore@acimmune.com |
European Investors & Media Chris Maggos LifeSci Advisors Phone: +41 79 367 6254 E-mail: 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.