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, 2020
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 26, 2020, 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. 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 2019
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 2019, and took note of the Reports of the Auditors.
Agenda Item 2: Appropriation of Profit
AC Immune shareholders approved that the profit for the year 2019 in the amount of KCHF 45,169 reduces the “accumulated losses brought forward” of KCHF 107,320, resulting in a new balance of “accumulated losses brought forward” of KCHF 62,151.
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 2019.
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 2020 to 30 June 2021, i.e., CHF 565,000 (cash based compensation plus pensionable social security costs); |
| B. | The maximum grant of equity or equity linked instruments for the members of the Board of Directors from 1 July 2020 to 30 June 2021 with maximum value of CHF 635,000 (equity or equity linked instruments at grant value plus pensionable social security costs); |
| C. | The total maximum amount of non-performance-related cash compensation for the members of the Executive Committee from 1 July 2020 to 30 June 2021, i.e., CHF 2,778,000 (cash based compensation plus pensionable social security costs); |
| D. | The total maximum amount of variable compensation for the members of the Executive Committee for the current year 2020, i.e., CHF 1,133,000 (cash based compensation plus pensionable social security costs); |
| E. | The maximum grant of equity or equity linked instruments for the members of the Executive Committee from 1 July 2020 to 30 June 2021 with maximum value of CHF 3,496,000 (equity or equity linked instruments at grant value plus pensionable social security costs); and |
| F. |
The 2019 Remuneration Report as filed with the US Securities and Exchange Commission as Annex 99.3 to the Company’s March 30, 2020 Form 6-K filing. |
Agenda Item 5: Re-elections
Agenda Item 5.1: Re-elections of the Members of the Board
AC Immune shareholders approved the re-election of Douglas Williams as member and as Chairman of the Board, the re-election of Martin Velasco as member and as Vice-Chairman of the Board, the re-election of Peter Bollmann, Andrea Pfeifer, Tom Graney, Werner Lanthaler and Roy Twyman as members of the Board of Directors, each until the end of the next Ordinary General Meeting.
Agenda Item 5.2: Re-elections 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 5.3: Re-elections of the Statutory Auditors
AC Immune shareholders approved the re-election of PricewaterhouseCoopers SA, in Pully, for a term of office of one year.
Agenda Item 5.4: Re-election of the Independent Proxy
AC Immune shareholders approved the re-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 6: Amendments to the Articles of Association
Agenda Item 6.1: Authorized Share Capital
AC Immune shareholders approved an amendment to the existing first paragraph of article 3a (Authorized Capital Increase of Share Capital) of the articles of association pertaining to a proposed increase by the Board of Directors in AC Immune’s share capital, in one or several steps, until 27 June 2022, by a maximum amount of CHF 290,000 by issuing a maximum of 14,500,000 registered shares with a par value of CHF 0.02 each, to be fully paid up. An increase of the share capital (i) by means of an offering underwritten by a financial institution, a syndicate or another third party or third parties, followed by an offer to the then-existing shareholders of the Company and (ii) in partial amounts, shall also be permissible.
Agenda Item 6.2: Conditional Capital Increase for Bonds and Similar Debt Instruments
AC Immune shareholders approved an amendment to the existing first paragraph of article 3b (Conditional Capital Increase for Bonds and Similar Debt Instruments) of the articles of association pertaining to the increase of the share capital of the company by a maximum amount of CHF 91,560.94 through the issue of a maximum of 4,578,047 registered shares, payable in full, each with a nominal value of CHF 0.02, through the exercise of conversion and/or option or warrant rights granted in connection with bonds or similar instruments, issued or to be issued by the Company or by subsidiaries of the Company, including convertible debt instruments.
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 26, 2020
EXHIBIT INDEX
|
Exhibit Number |
Description |
| 99.1 | Annual Ordinary Shareholders’ Meeting presentation |
| 99.2 | Press Release dated June 26, 2020 |
EXHIBIT 99.1
Pioneering Precision Medicine for Neurodegeneration NASDAQ: ACIU | Annual General Meeting | June 26, 2020 www.acimmune.com Version June 25 11.00am CET
Disclaimer This presentation contains statements that constitute “forward - looking statements” within the meaning of Section 27 A of the Securities Act of 1933 and Section 21 E 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 . These include : the impact of Covid - 19 on our business, suppliers, patients and employees and any other impact of Covid - 19 . 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 . © 2020 AC Immune. Not to be used or reproduced without permission 2 NASDAQ: ACIU | Annual General Meeting | June 2020
NASDAQ: ACIU | Annual General Meeting | June 2020 © 2020 AC Immune. Not to be used or reproduced without permission 3 Agenda 1. AC Immune’s leadership in neurodegenerative diseases 2. Achievements 2019/20 3. AC Immune’s business strategy 4. Pipeline update 5. Novel drug targets for neurodegenerative diseases 6. Near - term inflection points 7. Financial figures 8. Strategic outlook
1. AC Immune’s leadership in neurodegenerative diseases Andrea Pfeifer, CEO
Roadmap to successful therapies for NDDs 1 NASDAQ: ACIU | Annual General Meeting | June 2020 © 2020 AC Immune. Not to be used or reproduced without permission 5 ( 1 ) Neurodegenerative diseases ; ( 2 ) Reardon S, Nature 2018 ; ( 3 ) Pontecorvo MJ, et al . , Brain 2019 ; ( 4 ) Gordon BA, et al . , Brain 2019 ; ( 5 ) Positron emission tomography ; ( 6 ) Strydom A, et al . , Alzheimers Dement (NY) 2018 ; ( 7 ) Lott IT and Head E . , Nat Rev Neurol . 2019 ; ( 8 ) Robinson JL, et al . , Brain 2018 ; ( 9 ) Heneka MT et al . , Nat Rev Neurosci . 2018 ; ( 10 ) Wang S et al . , Int Immunopharmacol . 2019 ; ( 11 ) ( NOD) - like receptor protein 3 ; ( 12 ) 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 2 More homogeneous populations 6,7 Precision medicine 8 Target neuroinflammation 9,10 ▪ Prioritize primary and secondary prevention trials ▪ Access diagnostic tools for patient identification ▪ Develop monoclonal antibodies and small molecules for microglial balance targeting the inflammasome NLRP3 11 - ASC 12 pathway Target Tau 3,4 ▪ Develop therapies and use Tau PET 5 tracers to diagnose/select patients
AC Immune is focused on precision medicine in AD 1 and NDD 2 NASDAQ: ACIU | Annual General Meeting | June 2020 © 2020 AC Immune. Not to be used or reproduced without permission 6 Multiple targets and approaches enable mono - and combination therapies ■ Future treatment paradigms for NDD may involve different combinations of disease modifiers at various stages of a disease ■ Combination therapies may include combinations of immunotherapies or combinations of small and large molecules targeting proteinopathies and neuroinflammation
2. Achievements 2019/20
NASDAQ: ACIU | Annual General Meeting | June 2020 © 2020 AC Immune. Not to be used or reproduced without permission 8 ▪ Making every provision to protect the health of patients, staff, and investigators ▪ In continuous coordination with partners and important stakeholders including the Swiss government, trial investigators and contractors ▪ Maintaining productivity and integrity of our clinical development Covid - 19: minimal anticipated impact on milestone achievement Not modifying guidance: remain on track to deliver five clinical readouts in 2020 Executing r obust business continuity plan On track to deliver 2020 milestones Additional considerations ▪ Many key trials are already fully enrolled ▪ Patient follow up continuing virtually ▪ ACI - 24 in AD 1 : Phase 2, 12 - month interim data analysis will proceed as planned on a reduced patient data - set ▪ ACI - 24 in DS 2 : Plans to initiate Phase 2 in H2 2020 are progressing; to be initiated in line with public health guidance at that time ▪ Crenezumab: Phase 2 (API) study: Dosing temporarily interrupted due to country - wide order; patients dosed for >5 years as part of prevention study and data still anticipated in 2022 (1) Alzheimer’s disease; (2) Down syndrome
NASDAQ: ACIU | Annual General Meeting | June 2020 © 2020 AC Immune. Not to be used or reproduced without permission 9 x CHF 110 million from Lilly for small molecule Tau inhibitor and $50 million in exchange for a note, convertible to equity at a premium x Milestone payment for Tau PET tracer entering Phase 2 x New grant from MJFF for a - synuclein PET tracer Achieving partnership milestones Advancing/expanding clinical pipeline x Second Phase 2 trial of semorinemab in moderate AD x Phase 1b/2a trial of anti - phospho - Tau vaccine x Phase 1 trial of small molecule Tau inhibitor x Tau imaging substudy in ongoing API study of crenezumab Delivering program readouts x a - synuclein and TDP - 43 Proof of Concept ( PoC ) studies in Q3 2019 x Interim Phase 1b data for anti - Abeta vaccine in Down syndrome x Interim Phase 1b of anti - pTau vaccine ACI - 35 x Phase 1 SAD results for small molecule Tau inhibitor Establishing thought leadership x Key opinion leader (KOL) event on “untangling Tau pathology” x KOL event on treated AD in people with Down syndrome Unlocking platform potential x Novel biparatopic antibodies against a - synuclein 2019: Strong pipeline progress and further improved balance sheet Building on our track record of successful execution
3. AC Immune’s business strategy
AC Immune strengths © 2020 AC Immune. Not to be used or reproduced without permission A leader in neurodegenerative diseases ■ Addressing the largest market opportunity in healthcare ■ Pioneering precision medicine in neurodegenerative diseases ■ Highly productive validated discovery platforms for sustained growth to address misfolded proteins applicable across multiple diseases ■ SupraAntigen TM : vaccines and antibodies specific to disease - causing conformations ■ Morphomer TM : conformation - sensitive small molecules ■ Broad pipeline with four therapeutic candidates in Phase 2 ■ Multiple near - term value inflection points ■ Partnerships with Roche, Janssen Pharmaceuticals and Eli Lilly and Company ■ Complementary diagnostics in clinical development ■ Highly - valued preclinical assets in Tau, a - syn and TDP - 43 ■ CHF 277.9 million in cash 1 ; sufficiently funded to reach multiple value inflection points through at least Q1 2024 ■ Increasing investment into key areas of NeuroOrphan and neuroinflammation 1 2 3 4 5 11 NASDAQ: ACIU | Annual General Meeting | June 2020 (1) As of March 31 , 2020
Vision © 2020 AC Immune. Not to be used or reproduced without permission To become a global leader in precision medicine 1 for neurodegenerative diseases leveraging dual proprietary technology platforms to develop breakthrough mono - and combination therapies SupraAntigen TM Vaccines and antibodies specific to disease causing conformations Morphomer TM Conformation - sensitive small molecules Clinically Validated Technology Platforms Images: Hickman et al. , JBC 2011; Kroth et al., JBC 2012 (1) The goal of precision medicine is to deliver optimally targeted and timed interventions tailored to the individual disease drivers 12 NASDAQ: ACIU | Annual General Meeting | June 2020
Unlocking platform potential for next generation of innovations © 2020 AC Immune. Not to be used or reproduced without permission Multiple opportunities for value creation and future partnership (1) Positron emission tomography; (2) (NOD) - like receptor protein 3; (3) Apoptosis - associated speck protein containing a CARD; (4) Neuroinflammation 13 NASDAQ: ACIU | Annual General Meeting | June 2020 Monoclonal antibodies Bispecific antibodies Biparatopic antibodies Conformational liposomal vaccines Small molecule therapeutics PET 1 tracers diagnostics SupraAntigen ™ Morphomer ™ ▪ semorinemab (anti - Tau) ▪ crenezumab (anti - Abeta ) ▪ anti - a - syn ▪ anti - TDP - 43 ▪ anti - ASC 3 (NI 4 ) ▪ undisclosed ▪ a - syn ▪ undisclosed ▪ ACI - 35 (anti - pTau vaccine) ▪ ACI - 24 (anti - Abeta vaccine) ▪ ACI - 3024 (Tau inhibitor) ▪ a - syn inhibitor ▪ NLRP3 2 inhibitor ▪ PI - 2620 (Tau tracer) ▪ a - syn tracer ▪ TDP - 43 tracer
Business strategy: three - pillar approach © 2020 AC Immune. Not to be used or reproduced without permission Precision medicine ultimately creates differentiation 14 NASDAQ: ACIU | Annual General Meeting | June 2020 Vision Alzheimer’s disease (AD) Non - AD NeuroOrphans Diagnostics Technology platforms Values (1) Progressive supranuclear palsy; (2) Neurodegenerative diseases ▪ Develop best - in - class late stage assets in partnership ▪ Develop preventive/therapeutic vaccines as fully owned assets (ACI - 24) ▪ 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 ▪ Target neuroinflammation for NDD 2 as mono - and/or combination therapy Non - AD, NeuroOrphans ▪ Accelerate diagnostic pipeline to late stage development ▪ Use diagnostics for improved clinical trials and external partnerships Diagnostics
4. Pipeline update
Broad and robust pipeline in neurodegenerative diseases NASDAQ: ACIU | Annual General Meeting | June 2020 © 2020 AC Immune. Not to be used or reproduced without permission 16 Driven by validated proprietary technology platforms for sustained growth (1) Alzheimer’s disease ; (2) Positron emission tomography; (3) Progressive supranuclear palsy; (4) Prevention trial API - ADAD in Colombia; (5) AD - like cognitive impairment associated with Down syndrome TARGET PRODUCT CANDIDATE INDICATION DISCOVERY PRECLINICAL PHASE 1 PHASE 2 PHASE 3 PARTNER Tau semorinemab (anti - Tau antibody) AD 1 treatment ( prodromal / mild) AD treatment ( moderate) ACI - 35.030 (anti - pTau vaccine ) AD treatment ACI - 3024 (Tau inhibitor) AD treatment Tau - PET 2 tracer AD and PSP 3 Abeta crenezumab (anti - Abeta antibody) AD prevention 4 ACI - 24 (anti - Abeta vaccine) AD treatment ( Down syndrome 5 ) AD treatment Clinical - stage pipeline ( data readout expected in 2020) Biologic Small Molecule Diagnostic
NASDAQ: ACIU | Annual General Meeting | June 2020 © 2020 AC Immune. Not to be used or reproduced without permission 17 TARGET PRODUCT CANDIDATE INDICATION DISCOVERY PRECLINICAL PHASE 1 a - synuclein (a - syn) a - syn - PET 1 tracer PD 2 , a - synucleinopathies anti - a - syn antibody PD, NeuroOrphan Morphomer a - syn (a - syn inhibitor) PD, a - synucleinopathies TDP - 43 3 anti - TDP - 43 antibody NeuroOrphan TDP - 43 - PET tracer TDP - 43 - opathies Inflammasome anti - NLRP3 4 - ASC 5 antibody NeuroOrphan Morphomer - NLRP3 - ASC Non - CNS 6 Morphomer - NLRP3 - ASC NeuroOrphan Early - stage pipeline ( key milestone in 2020) (1) Positron emission tomography; ( 2 ) Parkinson’s disease (3) TAR DNA - binding protein 43; (4) ( NOD) - like receptor protein 3; (5) Apoptosis - associated speck protein containing a CARD; ( 6 ) Central nervous system Biologic Small Molecule Diagnostic Broad and robust pipeline in neurodegenerative diseases Driven by validated proprietary technology platforms for sustained growth
5. Novel drug targets for neurodegenerative diseases
NASDAQ: ACIU | Annual General Meeting | June 2020 © 2020 AC Immune. Not to be used or reproduced without permission 19 30% 35% iAD Pure Tau and Abeta 35% TDP - 43 / a - syn a - syn TDP - 43 hAD iAD 3 ; intermediate ; hAD 2 , high levels of co - pathologies Adapted from Robinson et al, Brain, 2018 hAD 2 (iAD 3 ) shows high levels of co - pathologies: ▪ 55% (41%) a - syn ; ▪ 40% (33%) TDP - 43 with an overall prevalence of 70% (65%) of co - pathologies ▪ The prevalence of co - pathologies in AD 1 and other NDD 4 may indicate a need for different therapies at different stages ▪ Clinical trial participants may be better defined by their various proteinopathies ▪ Patient sub - classification may lead to improved clinical outcome ▪ Combination therapy may be the ultimate requirement (1) Alzheimer's disease; (2) High level of Alzheimer’s disease neuropathological change; (3) Intermediate level of Alzheimer’ s d isease neuropathological change; (4) Neurodegenerative diseases Why do we need precision medicine in AD 1 ? High level of other proteinopathies and co - pathologies in AD
TDP - 43 1 and alpha - synuclein: drivers of value creation in 2020 and beyond Broad applications in NDD and AD Established hallmarks in NDD Including NeuroOrphan indications and Parkinson’s disease Novel therapeutic targets in Alzheimer’s disease High levels of a - syn and/or TDP - 43 co - pathology Highlights the need for precision medicine For faster and more accurate diagnosis, treatment and monitoring of disease progression Significant market opportunity AC Immune’s therapeutic and diagnostic programs are amongst the most comprehensive in the field (1) TAR DNA - binding protein 43 NASDAQ: ACIU | Annual General Meeting | June 2020 © 2020 AC Immune. Not to be used or reproduced without permission 20
NASDAQ: ACIU | Annual General Meeting | June 2020 © 2020 AC Immune. Not to be used or reproduced without permission 21 2 3 Enhance phagocytic clearance Inhibit seeding and spreading Misfolded proteins form aggregates and inclusion bodies leading to neuronal death Aggregates spread extracellularly in a “prion - like” fashion Diseased neuron with pathological protein aggregates Healthy neuron Dying neuron Aggregated protein 1 Bind extracellular aggregates (1) TAR DNA - binding protein 43; (2) Alpha - synuclein; (3) Neurodegenerative diseases; (4) Alzheimer’s disease Emerging targets in neurodegenerative disease Antibodies targeting TDP - 43 1 and a - syn 2
NASDAQ: ACIU | Annual General Meeting | June 2020 © 2020 AC Immune. Not to be used or reproduced without permission 22 Only anti - TDP - 43 antibody reported with demonstrated in vivo activity Established preclinical proof - of - concept Ref: AC Immune unpublished data pTDP - 43 2 ( Immunohistochemistry ) Insoluble TDP - 43 ( biochemistry ) V e h i c l e A C I - 5 8 9 1 0 5000 10000 15000 RIPA insoluble fraction I n s o l u b l e T D P - 4 3 ( R e l a t i v e u n i t s ) Vehicle ACI-5891 ✱✱✱✱ T g ( r N L S 8 ) V e h i c l e T g ( r N L S 8 ) A C I - 5 8 9 1 0 25 50 75 100 125 pTDP-43 in Cortex p T D P - 4 3 d e n s i t y ( n u m b e r / m m 2 ) Tg(rNLS8) Vehicle Tg(rNLS8) ACI-5891 ✱✱ Vehicle ACI - 5891 Vehicle ACI - 5891 Isotype control ACI - 5891 (1) rNLS8 TDP - 43 transgenic mouse model; Walker et al., Acta Neuropathol ., 2015; (2) Phosphorylated TDP - 43; (3) Investigational new drug Reduction of pathological TDP - 43 in vivo 1 Inhibition of TDP - 43 aggregation in vitro Recombinant TDP - 43 aggregation assay Key results ▪ In vitro , 98% inhibition of TDP - 43 aggregation ▪ In vivo , significant reduction in TDP - 43 neuro - pathology Next steps ▪ Complete humanization of lead candidate; start IND 3 - enabling studies in Q2 2020 22
NASDAQ: ACIU | Annual General Meeting | June 2020 © 2020 AC Immune. Not to be used or reproduced without permission 23 Brain PK 2 profile Target engagement by micro - autoradiography Binding affinity on FTD type - C brain - derived TDP - 43 aggregates Key results ▪ Lead candidate shows selective TDP - 43 binding ▪ Target engagement confirmed by micro - autoradiography ▪ PK study confirmed good, rapid brain uptake (4.11%) Next steps ▪ Further optimize target affinity and PK profile; declare clinical lead candidate Ref: AC Immune unpublished data 23 First - in - class TDP - 43 PET 1 imaging tracer – Discovery Phase Designed to facilitate clinical development and enable precision medicine (1) Positron emission tomography; (2) Pharmacokinetic
NASDAQ: ACIU | Annual General Meeting | June 2020 © 2020 AC Immune. Not to be used or reproduced without permission 24 (1) Investigational new drug; (2) Parkinson’s disease; (3) M83 transgenic mice inoculated with human a - syn preformed fibrils; (4 ) Human cell line susceptible to a - syn seeding; (5) p - syn antibody (pSer129; Abcam, UK) Phosphorylated S129 a - syn (p - Syn 5 ) cortex immunohistochemistry Recombinant a - syn aggregation assay Key results ▪ In vitro , ACI - 5755 significantly inhibits a - syn aggregation and inhibits uptake and seeding capacity of a - syn aggregates in cells ▪ In vivo , ACI - 5755 significantly decreases a - syn spreading Next steps ▪ Advance towards IND filing p - Syn staining density 24 Ref: AC Immune data presented at AD/PD 2020 Cellular spreading assay 4 Aggregation half - times (h) Control ACI - 5755 I s o t y p e c o n t r o l A C I - m A b - 1 A C I - m A b - 5 A C I - m A b - 1 0 0 25 50 75 100 125 [mAb] (nM) a - s y n a g g r e g a t e s ( % ) ** ** * a - syn aggregates (%) Lead candidate ACI - 5755 currently in IND 1 - enabling studies in PD 2 Targeting spreading of pathological a - syn with selective antibody Inhibition of a - syn aggregation in vitro Reduction of pathological a - syn in vivo 3
NASDAQ: ACIU | Annual General Meeting | June 2020 © 2020 AC Immune. Not to be used or reproduced without permission 25 (1) Positron emission tomography; (2) Parkinson’s disease; (3) Non - human primates; (4) Data shown for 18F - labeled ACI - 3710 by positron emission tomography (PET); (5) Square of the coefficient of multiple correlation; (3) Non - human primates; (4) Data shown for 18F - labeled ACI - 3710 by PET 1 ; ( 6) Injected dose per gram of brain; (7) Dementia with Lewy bodies; (8) Multiple system atrophy; (9) Alpha - synuclein gene mutation Pharmacokinetic (PK) profile in NHP 3 Biochemical and histological radiography assays Brain uptake Wash - out Time to C max ID/g 6 brain (%) Peak/half Peak 5min 4.0 ~ 20min 6 5 4 3 2 1 0 SUV (g/ml) 0 30 60 90 120 150 180 Time (min) 18F - PK profile in different brain regions 4 Capotosti, AD/PD Conference, Lisbon 2019 Compound concentration ( nM ) Compound concentration ( nM ) 0.01 1 100 10000 - 20 0 20 40 60 80 100 120 % competition 0.1 1 10 100 1000 10000 - 20 0 20 40 60 80 100 120 % competition Ki 5 =0.6 nM (R 2 =0.97) 5 Ki 5 =1.7 nM (R 2 =0.88) 5 Key results ▪ Highly specific, low nanomolar binding in human PD, DLB 7 and MSA 8 brains ▪ Between 500 to 1000 - fold selectivity over potential Abeta co - pathologies ▪ Favorable PK profile in NHPs and mice Next steps ▪ 2 nd - gen study in genetic populations, i.e. MSA and SNCA 9 ▪ Advance 3 rd - gen candidate to clinical stage in Q4 2020 Binding to PD - derived a - syn aggregates Binding to Lewy bodies in PD brains 25 A - syn PET 1 imaging tracer – First - in - Human Potentially the first selective diagnostic agent for PD 2
6. Near - term inflection points
NASDAQ: ACIU | Annual General Meeting | June 2020 © 2020 AC Immune. Not to be used or reproduced without permission 27 Multiple upcoming clinical catalysts to drive value in 2020 1 st Tau antibody Phase 2 data expected 3 Tau programs reporting clinical data 5 clinical readouts expected this year Phase 2 readouts s emorinemab mild / prodromal AD ACI - 24 AD (interim data) Phase 1b readouts ACI - 35.030 1 AD (interim data) ACI - 24 Down syndrome Phase 1 readouts ACI - 3024 healthy volunteers Initiation ACI - 24 Phase 2 – Down syndrome (1) Phase 1b/2a study
NASDAQ: ACIU | Annual General Meeting | June 2020 © 2020 AC Immune. Not to be used or reproduced without permission 28 Multiple upcoming catalysts to drive value in 2020 ( 1) Alzheimer’s disease; (2) Cohort 1; safety/tolerability; immunogenicity ; (3) Phase 1b completion expected in Q2; (4) AD - like cognitive impairment associated with Down syndrome; (5) Phase 1 completion expected in Q2; (6) Investigational new drug; (7) Parkinson’s disease; (8) TAR DNA - binding protein 43; (9) ( NOD) - like receptor protein 3; (10) Apoptosis - associated speck protein containing a CARD; (11) Central nervous system Clinical Preclinical AD 1 Treatment (Prodromal / mild) AD Treatment in Down syndrome 4 AD Treatment AD Treatment PD, synucleinopathies AD Treatment NeuroOrpha n PD, a - synucleinopathies NeuroOrpha n NeuroOrphan DISCOVERY PRECLINICAL PHASE 1 DISCOVERY PRECLINICAL PHASE 1 PHASE 2 semorinemab (anti - Tau antibody) Phase 2 primary completion (estimated; last patient, last visit ) ACI - 35.030 (anti - pTau vaccine) Phase 1b/2a in AD interim analysis 2 ACI - 24 (anti - Abeta vaccine) Phase 1b full study reporting in Down syndrome 3 ACI - 24 (anti - Abeta vaccine) Phase 2 12 - month interim analysis in AD ACI - 3024 (Tau inhibitor) Phase 1 results (healthy volunteers) disclosed by partner (expected) 5 anti - a - syn anibody Start IND 6 - enabling studies for lead candidate (achieved ) Morphomer a - syn (a - syn inhibitor) Identify first biologically active small molecule anti - TDP - 43 8 antibody Declare clinical lead; start IND - enabling studies a - syn PET tracer Advance 3 rd - gen candidate to clinical stage Morphomer - NLRP3 9 - ASC 10 Declare lead (non - CNS 11 ) anti - NLRP3 - ASC antibody Declare pre - lead Q1 Q2 Q4 H2 Q2 Biologic Small Molecule Diagnostic PD 7 , NeuroOrphan
7. Financial figures
▪ CHF 313 million from investor funds ▪ CHF 334 million in partnering related funds 3,4 ▪ CHF 3 billion in total potential payments plus potential royalties outstanding Substantial funds from partnerships complement equity investments © 2020 AC Immune. Not to be used or reproduced without permission 30 NASDAQ: ACIU | Annual General Meeting | June 2020 Distinguished 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 (1) Based on latest schedule 13G and 13F filings; (2) Converted to CHF based on exchange rates at times of receipt; (3) Miles ton e payments as of March 31, 2020; (4) With Lilly convertible loan Partner equity investments Prosight Capital 128.5 CHF 334 million CHF 313 million
NASDAQ: ACIU | Annual General Meeting | June 2020 © 2020 AC Immune. Not to be used or reproduced without permission 31 2019 Financial update Strong cash position Substantial partnership revenues R&D expenses G&A expenses IFRS income/(loss) Sufficiently funded to reach multiple value inflection points through at least Q1 2024 1 ▪ CHF 288.6 million compared to CHF 186.5 million at December 31, 2018 ▪ Received CHF 111.0 million in 2019, an increase of CHF 103.8 million compared to 2018 ▪ Increased by CHF 6.2 million year - over - year to CHF 50.4 million in 2019 ▪ Increased by CHF 3.6 million year - over - year to CHF 16.1 million in 2019 ▪ Net income after taxes of CHF 45.4 million in 2019, compared with net loss of CHF 50.9 million in 2018 (1) Excluding potential future milestone payments
8. Strategic outlook
Ongoing strong financial position CHF 277.9 million in cash 1 , ensuring the Company is fully financed through Q1 2024 Industry - leading molecules against multiple key targets; i.e. anti - a - syn and anti - TDP - 43 antibodies advancing to preclinical development Pipeline progression 5 clinical data readouts in 2020 Multiple near - term value inflection points, including the 1 st Phase 2 readout of an anti - Tau antibody in Alzheimer’s disease Pioneering precision medicine Addressing large market opportunity with differentiated, patient - focused approach 33 Drivers of value creation in 2020 and beyond NASDAQ: ACIU | Annual General Meeting | June 2020 © 2020 AC Immune. Not to be used or reproduced without permission (1) As of March 31, 2020
AC Immune NASDAQ: ACIU | Annual General Meeting | June 2020 © 2020 AC Immune. Not to be used or reproduced without permission 34 We continue to shape the future of neurodegeneration by discovering and developing breakthrough therapies through pioneering science and precision medicine
EXHIBIT 99.2
 |
Press Release |
AC Immune Announces Results of Annual General Meeting
Lausanne, Switzerland, 26 June, 2020 – AC Immune SA (NASDAQ: ACIU), a Swiss-based, clinical-stage biopharmaceutical company with a broad pipeline focused on neurodegenerative diseases, announced AC Immune shareholders approved all of the resolutions as proposed by the Board of Directors at today's Annual General Meeting (AGM) in Lausanne.
At the AGM, shareholders re-elected Douglas Williams, Martin Velasco, Peter Bollmann, Andrea Pfeifer, Thomas Graney, Werner Lanthaler and Roy Twyman to their positions on the Board of Directors. Douglas Williams and Martin Velasco will continue to serve as Chairman and Vice-Chairman of the Board, respectively.
Douglas Williams, Chairman of the Board, said: “The Company is gathering momentum on the back of strong progress, and we remain on track to meet multiple value-creating milestones this year with five clinical readouts expected in 2020. We are especially excited about the Phase 2 trial evaluating our anti-Tau antibody semorinemab in Alzheimer’s disease. The primary completion of the trial is expected soon and we expect top line data in the second half of 2020. We are also extremely pleased to report AC Immune’s solid financial position, with operations fully funded through at least Q1 2024.”
AC Immune has always maintained a robust business continuity plan. During the Covid-19 outbreak, every provision has been made to protect the health of patients, staff and investigators, as well as the productivity and integrity of our clinical development. Importantly, we currently remain on track to deliver all clinical and preclinical readouts expected in 2020. The Swiss Government’s management of Covid-19 means that businesses have been able to return to near normal working practices with all AC Immune staff now back on site in Lausanne.
As part of its efforts to ensure stakeholder safety during the Covid-19 outbreak, AC Immune held only the mandatory part of the AGM as stipulated by Swiss law and by the Company’s Articles of Association. Voting took place via the independent proxy.
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 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 Roche/Genentech, Eli Lilly and Company and Janssen Pharmaceuticals.
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For further information, please contact:
Head of Investor Relations Joshua Drumm, Ph.D. 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. These include: the impact of Covid-19 on our business, suppliers, patients and employees and any other impact of Covid-19. 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.
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