1. Dr. Colowick has more than 20 years of experience in large and emerging biotech companies

    Led investments for several clinical-stage companies as a Partner at Sofinnova Investments

    LAUSANNE, Switzerland, March 31, 2021 (GLOBE NEWSWIRE) -- AC Immune SA (NASDAQ:ACIU), a clinical-stage biopharmaceutical company pioneering precision medicine for neurodegenerative diseases, today announced that Alan Colowick, MD, MPH, a deeply experienced biotech and investment executive, was elected to the Company's Board of Directors at an extraordinary shareholders' meeting today.

    Dr Colowick has more than 20 years of industry experience in both large and emerging biotech companies, serving in a broad array of board, senior executive, clinical, regulatory…

    Dr. Colowick has more than 20 years of experience in large and emerging biotech companies

    Led investments for several clinical-stage companies as a Partner at Sofinnova Investments

    LAUSANNE, Switzerland, March 31, 2021 (GLOBE NEWSWIRE) -- AC Immune SA (NASDAQ:ACIU), a clinical-stage biopharmaceutical company pioneering precision medicine for neurodegenerative diseases, today announced that Alan Colowick, MD, MPH, a deeply experienced biotech and investment executive, was elected to the Company's Board of Directors at an extraordinary shareholders' meeting today.

    Dr Colowick has more than 20 years of industry experience in both large and emerging biotech companies, serving in a broad array of board, senior executive, clinical, regulatory, and commercial positions. He has a deep understanding of value creation and growth strategies, serving as a Partner at Sofinnova Investments, where he led investments for several clinical-stage companies.

    Douglas Williams, Ph.D., Chairman of AC Immune SA, commented: "The wealth of experience and credibility Dr. Colowick brings to AC Immune's Board will be invaluable as we continue to execute on our corporate strategy and reinforce our scientific leadership in the field of neurodegenerative diseases. His extensive expertise in biotech from both industry and investment standpoints – including from Celgene, Amgen and Sofinnova – will bring an important perspective to our pipeline and corporate development. We are thrilled to welcome him as our newest Director."

    Dr. Colowick commented: "I am delighted to be elected to the Board of Directors at what is a particularly exciting moment for AC Immune. By pioneering a personalized medicine approach that properly recognizes the complexity of neurodegenerative disease, the Company has positioned itself at the forefront of the field, poised for sustained growth. I look forward to working with my new colleagues as we continue to advance one of the industry's broadest and most diversified pipelines in neurodegeneration."

    Prior to his time at Sofinnova, Dr. Colowick was Executive Vice President and served in various leadership roles at Celgene Corporation, including as President for Celgene's Europe, Mid-East, and Africa regions and as Senior Vice President of Global Medical Affairs. Before joining Celgene, he was the Chief Executive Officer at Gloucester Pharmaceuticals, Inc. where he led a private round of financing prior to the company's acquisition by Celgene in 2010. Dr. Colowick has also served as the President of Oncology at Geron Corporation, as Chief Medical Officer of Threshold Pharmaceuticals, and in numerous positions of increasing responsibility at Amgen culminating with his role as VP, Medical Affairs Europe.

    Dr. Colowick also has extensive Board experience that includes current roles on the Board of Directors for Personalis, Inc., XyloCor Therapeutics, and InCarda Therapeutics, and prior roles as Chairman of the Board including VelosBio (sold to Merck in 2020 for $2.75 billion) and Principia Biopharma (sold to Sanofi in 2020 for $3.7 billion). He received his medical degree from Stanford University, a Master's in Public Health from Harvard University, and a B.S. in Molecular Biology from the University of Colorado. Additionally, Dr. Colowick has completed specialty training in Hematology-Oncology at Harvard Medical School, the Dana Farber Cancer Institute, and Brigham and Women's Hospital in Boston, USA.

    Prior to the meeting, the Board withdrew agenda item 2.

    About AC Immune SA

    AC Immune SA is clinical-stage biopharmaceutical company that aims to become a global leader in precision medicine for neurodegenerative diseases, including Alzheimer's disease, Parkinson's disease, and NeuroOrphan indications driven by misfolded proteins. The Company's two clinically validated technology platforms, SupraAntigenTM and MorphomerTM, fuel its broad and diversified pipeline of first- and best-in-class assets, which currently features nine therapeutic and three diagnostic candidates, six of which are currently in clinical trials. AC Immune has a strong track record of securing strategic partnerships with leading global pharmaceutical companies including Genentech, a member of the Roche Group, Eli Lilly and Company and Janssen Pharmaceuticals, resulting in substantial non-dilutive funding to advance its proprietary programs and >$3 billion in potential milestone payments.

    For further information, please contact:

    Head of Investor Relations

    Joshua Drumm, Ph.D.

    AC Immune

    Phone: +1 917 809 0814

    Email:



    US Media

    Katie Gallagher

    LaVoie Health Science

    Phone: +1 617 792 3937

    Email:



     European Investors & Media

    Chris Maggos

    LifeSci Advisors

    Phone: +41 79 367 6254

    Email:



    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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  2. LAUSANNE, Switzerland, March 31, 2021 (GLOBE NEWSWIRE) -- AC Immune SA (NASDAQ:ACIU), a clinical-stage biopharmaceutical company pioneering precision medicine for neurodegenerative diseases, will host an investor webinar today to discuss the unique benefits of the Company's innovative MorphomerTM technology platform, which generates first-in-class therapeutic and diagnostic candidates to power AC Immune's precision medicine approach for neurodegenerative diseases. The live webinar begins at 10am ET and can be accessed here.

    Prof. Andrea Pfeifer, Ph.D., CEO of AC Immune SA, commented: "Our industry-leading precision medicine approach aims to address the complexity and heterogeneity of neurodegenerative diseases by pairing highly selective…

    LAUSANNE, Switzerland, March 31, 2021 (GLOBE NEWSWIRE) -- AC Immune SA (NASDAQ:ACIU), a clinical-stage biopharmaceutical company pioneering precision medicine for neurodegenerative diseases, will host an investor webinar today to discuss the unique benefits of the Company's innovative MorphomerTM technology platform, which generates first-in-class therapeutic and diagnostic candidates to power AC Immune's precision medicine approach for neurodegenerative diseases. The live webinar begins at 10am ET and can be accessed here.

    Prof. Andrea Pfeifer, Ph.D., CEO of AC Immune SA, commented: "Our industry-leading precision medicine approach aims to address the complexity and heterogeneity of neurodegenerative diseases by pairing highly selective and conformation-specific therapeutics with first- or best-in-class companion diagnostics. This approach is fueled, in part, by our clinically validated MorphomerTM platform, which combines decades of medicinal chemistry and drug development expertise to accelerate the design, synthesis, and development of brain- and cell-penetrant small molecules capable of binding to intracellular pathological proteins.

    "Through the successful application of this platform, we are advancing a comprehensive pipeline of therapeutic and diagnostic Morphomers™ that address key targets such as Tau, TDP-43, alpha-synuclein, and the NLRP3 inflammasome. We are pleased to provide an overview of the discovery and development of these programs, several of which have been validated in the clinic, as well as outline the significant milestones we expect to achieve across our portfolio or Morphomer™- and SupraAntigen™-derived portfolio over the coming months."

    The webinar features presentations and a Q&A session with members of AC Immune's Management and Research and Development Teams: Prof. Andrea Pfeifer; Dr. Marie Kosco-Vilbois, Chief Scientific Officer; Dr. Sonia Poli, Life Cycle Leader; and Dr. Francesca Capotosti, Group Leader, in vivo Pharmacology and Non-Clinical Safety.

    Key highlights from the event:

    AC Immune's Morphomer™ technology enables the Company to deliver on its vision for precision medicine by fulfilling the need for differentiated therapies and a more comprehensive panel of diagnostic agents to characterize neurodegenerative diseases at the individual patient level.

    • Brain- and cell-penetrant Morphomer™ therapeutics that disrupt and/or inhibit intracellular protein aggregation may preserve neurons and prevent spreading of pathology and disease progression
    • Earlier, more reliable detection of specific neuropathologies may unlock the value of disease-modifying therapeutics and create a pathway for personalized combination therapies

    AC Immune's Morphomer™ platform has generated significant value through partnership and clinical validation and will continue to drive future value as early-stage programs mature.

    • Tau-targeted therapeutic and diagnostic Morphomers™ have generated more than CHF 174 million to date from strategic partnerships with the potential for considerable future milestone payments and royalties
    • The Company's current portfolio of therapeutic and diagnostic Morphomer™ candidates targeting TDP-43, alpha-synuclein and the NLRP3 inflammasome can address multiple significant market opportunities in neurodegenerative and non-CNS indications
    • The Morphomer™ platform can rapidly deliver first-/best-in-class small molecule candidates against emerging targets

    The unique benefits and competitive advantages of AC Immune's MorphomerTM platform include:

    • A highly focused, proprietary library of ~12,000 conformation-specific small molecules reflecting years of know-how and enrichment for compounds that bind mis-folded, aggregated protein structures
    • Efficient generation of CNS-optimized compounds with favorable brain penetration and pharmacokinetics
    • Rational design and deep expertise in medicinal chemistry to ensure optimized candidates bind selectively to pathological forms of misfolded proteins inside neurons at the earliest stage of disease
    • A proprietary suite of cellular and functional assays that use patient-derived brain samples to enable rapid identification and validation of successful compounds
    • Broad applicability as potentially disease-modifying therapies as well as precision diagnostics, directed against both established and novel neurodegenerative disease targets
    • Validation both clinically and through collaboration agreements with industry leaders Eli Lilly and Company and Life Molecular Imaging

    Morphomer Tau candidate ACI-3024 achieves potentially therapeutic target levels in the cerebrospinal fluid (CSF) at the highest administered dose in a Phase 1 study – the first therapeutic Morphomer candidate to be tested in humans.

    • Single and multiple dosing with ACI-3024 resulted in dose-dependent exposure, and after multiple doses, ACI-3024 concentrations in CSF exceeded target concentrations based on animal studies
    • ACI-3024 is being evaluated for efficacy in models of rare Tauopathies, while AC Immune and strategic partner Eli Lilly and Company have decided to pursue other promising Tau Morphomer candidates with the desired CSF exposure and selectivity for pathological aggregated Tau for potential clinical development in Alzheimer's disease
    • Platform validation has positive readthrough for earlier-stage candidates targeting a-syn and NLRP3

    Morphomer™-derived positron emission tomography (PET) imaging agents are first-/best-in-class, representing potential game changers for alpha-synuclein-, TDP-43- and certain Tau-driven diseases.

    • Published results for AC Immune's differentiated Tau PET tracer, PI-2620, demonstrate its ability to reliably detect 3- and 4-repeat Tau protein, identifying early Tau pathology in Alzheimer's disease patients and reproducibly differentiating patients with Alzheimer's and progressive supranuclear palsy from those with other disease pathologies such as alpha-synucleinopathies
    • Clinical-stage alpha-synuclein PET tracer ACI-12589 provides specific signal in tissue from Parkinson's disease patients and differentiates between disease and non-disease controls
    • First-in-class TDP-43 PET tracer candidates show nanomolar affinities on patient-derived brain tissue and rapid uptake in vivo

    Dr. Kosco-Vilbois concluded: "As the field expands its understanding of co-pathologies and the heterogeneity inherent to neurodegenerative diseases, it becomes increasingly clear that precision medicine will be the future of this treatment landscape. Our proprietary Morphomer™ and SupraAntigen™ technology platforms and the deep expertise at AC Immune give us the ability to remain at the forefront of this paradigm shift."

    About AC Immune SA

    AC Immune SA is clinical-stage biopharmaceutical company that aims to become a global leader in precision medicine for neurodegenerative diseases, including Alzheimer's disease, Parkinson's disease, and NeuroOrphan indications driven by misfolded proteins. The Company's two clinically validated technology platforms, SupraAntigenTM and MorphomerTM, fuel its broad and diversified pipeline of first- and best-in-class assets, which currently features nine therapeutic and three diagnostic candidates, six of which are currently in clinical trials. AC Immune has a strong track record of securing strategic partnerships with leading global pharmaceutical companies including Genentech, a member of the Roche Group, Eli Lilly and Company, and Janssen Pharmaceuticals, Inc., resulting in substantial non-dilutive funding to advance its proprietary programs and >$3 billion in potential milestone payments.

    For further information, please contact:

    Head of Investor Relations

    Joshua Drumm, Ph.D.

    AC Immune

    Phone: +1 917 809 0814

    Email:

    US Media

    Katie Gallagher

    LaVoie Health Science

    Phone: +1 617 792 3937

    Email:

      
     European Investors & Media

    Chris Maggos

    LifeSci Advisors

    Phone: +41 79 367 6254

    Email:

    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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  3. Therapeutic and diagnostic Morphomers™ enable AC Immune's unique precision medicine approach for neurodegenerative diseases

    Webinar will take place on Wednesday, March 31, 2020 at 10:00 AM ET

    LAUSANNE, Switzerland, March 26, 2021 (GLOBE NEWSWIRE) -- AC Immune SA (NASDAQ:ACIU), a clinical-stage biopharmaceutical company pioneering precision medicine for neurodegenerative diseases, today announced that it will host a corporate update webinar on Wednesday, March 31st at 10:00 AM ET until 11:30 AM ET.

    During the webinar, members of the AC Immune Management and Research and Development Teams will discuss the unique benefits of the Company's innovative Morphomer™ technology platform, which accelerates the design, synthesis, and development…

    Therapeutic and diagnostic Morphomers™ enable AC Immune's unique precision medicine approach for neurodegenerative diseases

    Webinar will take place on Wednesday, March 31, 2020 at 10:00 AM ET

    LAUSANNE, Switzerland, March 26, 2021 (GLOBE NEWSWIRE) -- AC Immune SA (NASDAQ:ACIU), a clinical-stage biopharmaceutical company pioneering precision medicine for neurodegenerative diseases, today announced that it will host a corporate update webinar on Wednesday, March 31st at 10:00 AM ET until 11:30 AM ET.

    During the webinar, members of the AC Immune Management and Research and Development Teams will discuss the unique benefits of the Company's innovative Morphomer™ technology platform, which accelerates the design, synthesis, and development of CNS-optimized, conformation-specific small molecules directed against pathological proteins. The platform has produced multiple clinically validated therapeutic and diagnostic candidates that bind selectively to target proteins intracellularly, at the earliest stages of disease.

    The current Morphomer™ pipeline includes two clinical-stage diagnostic candidates (Tau-PET tracer and alpha-synuclein-PET tracer), and one therapeutic candidate that has completed Phase 1 (Morphomer™ Tau ACI-3024). Additional first-in-class Morphomer™-derived therapeutic and diagnostic candidates targeting Tau, alpha-synuclein, TDP-43 and NLRP3-ASC are in preclinical development. Together with the Company's SupraAntigen™-derived therapeutic antibody and vaccine candidates, AC Immune's comprehensive Morphomer™ pipeline enables a differentiated Precision Medicine approach against multiple key proteins by pairing the Company's targeted therapeutics with proprietary companion diagnostics.

    Following the formal presentations, there will be an interactive virtual roundtable discussion between the audience and the AC Immune Management and Research and Development Teams.

    To register for the webinar, please click here.

    Webinar Speakers

    Andrea Pfeifer, Ph.D.                             

    Chief Executive Officer

    AC Immune

    Marie Kosco-Vilbois, Ph.D.  

    Chief Scientific Officer

    AC Immune

    Sonia Poli, Ph.D.

    Life Cycle Leader

    AC Immune

    Francesca Capotosti, Ph.D.

    Group Leader, In vivo Pharmacology and Non-Clinical Safety

    AC Immune

    About AC Immune SA

    AC Immune SA is clinical-stage biopharmaceutical company that aims to become a global leader in precision medicine for neurodegenerative diseases, including Alzheimer's disease, Parkinson's disease, and NeuroOrphan indications driven by misfolded proteins. The Company's two clinically validated technology platforms, SupraAntigenTM and MorphomerTM, fuel its broad and diversified pipeline of first- and best-in-class assets, which currently features nine therapeutic and three diagnostic candidates, six of which are currently in clinical trials. AC Immune has a strong track record of securing strategic partnerships with leading global pharmaceutical companies including Genentech, a member of the Roche Group, Eli Lilly and Company, and Janssen Pharmaceuticals, Inc., resulting in substantial non-dilutive funding to advance its proprietary programs and >$3 billion in potential milestone payments.

    For further information, please contact:

    Head of Investor Relations

    Joshua Drumm, Ph.D.

    AC Immune

    Phone: +1 917 809 0814

    Email:

    US Media

    Katie Gallagher

    LaVoie Health Science

    Phone: +1 617 792 3937

    Email:

      
     European Investors & Media

    Chris Maggos

    LifeSci Advisors

    Phone: +41 79 367 6254

    Email:

    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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    • Anti-pTau Alzheimer's vaccine delivers potent immunogenicity in ongoing Phase 1b/2a study, supporting further development into Phase 2/3
    • Anti-Abeta Alzheimer's vaccine advancing based on Phase 1b safety and immunogenicity results in Down syndrome; further interim results expected in Q2 for Phase 2 in Alzheimer's disease

    • Morphomer™ Tau aggregation inhibitor achieves target brain exposure in Phase 1; program advancing in NeuroOrphan indications and Alzheimer's disease

    • First-in-class alpha-synuclein PET diagnostic to report clinical results in Q3 2021

    • Advancing multiple candidates targeting the NLRP3 inflammasome pathway for CNS and non-CNS indications

    • Ongoing strong financial position of CHF 225.9 million in cash ensures the Company is fully financed…
    • Anti-pTau Alzheimer's vaccine delivers potent immunogenicity in ongoing Phase 1b/2a study, supporting further development into Phase 2/3
    • Anti-Abeta Alzheimer's vaccine advancing based on Phase 1b safety and immunogenicity results in Down syndrome; further interim results expected in Q2 for Phase 2 in Alzheimer's disease



    • Morphomer™ Tau aggregation inhibitor achieves target brain exposure in Phase 1; program advancing in NeuroOrphan indications and Alzheimer's disease



    • First-in-class alpha-synuclein PET diagnostic to report clinical results in Q3 2021



    • Advancing multiple candidates targeting the NLRP3 inflammasome pathway for CNS and non-CNS indications



    • Ongoing strong financial position of CHF 225.9 million in cash ensures the Company is fully financed through Q1 2024, excluding potential incoming milestones

    LAUSANNE, Switzerland, March 23, 2021 (GLOBE NEWSWIRE) -- AC Immune SA (NASDAQ:ACIU), a clinical-stage biopharmaceutical company pioneering precision medicine for neurodegenerative diseases, today reported its financial results for the year ended December 31, 2020. The Company also provided an overview of its execution strategy and anticipated clinical and preclinical milestones for 2021, as well as the strong progress being made across its broad portfolio of therapeutic and diagnostic product candidates.

    Prof. Andrea Pfeifer, CEO of AC Immune SA, commented: "We began 2021 with strong momentum based on the effective execution of our multi-pronged clinical development growth strategy. This is exemplified by our anti-pTau vaccine, which recently demonstrated highly potent immune responses against pathological Tau and remarkable safety in patients with early Alzheimer's disease (AD). We are also creating future value by accelerating development of our proprietary, first-in-class candidates addressing novel targets in neurodegeneration, such as our promising alpha-synuclein PET tracer, which will generate initial clinical results this year, and our highly valued programs targeting the NLRP3 inflammasome. Our strong track record shows that expanding our efforts to advance these key early-stage programs may lead to multiple future opportunities for strategic partnership as well as in-house clinical development for select indications. In parallel, we continue to collaborate with our global partners to advance our later-stage clinical programs toward key inflection points. Looking forward in 2021, we expect to build upon our successes and continue innovating as a leader in precision medicine for neurodegenerative disease."

    2020 and Q1 2021 Research & Development Highlights



    Clinical Pipeline advancement

    • Reported promising interim Phase 1b/2a results for ACI-35.030, a novel anti-phospho-Tau (pTau) vaccine candidate showing strong safety and high titers of antigen-specific antibodies in 100% of older patients with early AD. The study is currently enrolling patients into the highest dose group, with further clinical readouts expected this year.
    • Advanced next-generation alpha-synuclein positron emission tomography (PET) tracer candidate, ACI-12589, into a first-in-human clinical study, with an expected data readout in Q3 2021
    • Reported topline Phase 2 results for semorinemab, the Company's investigational monoclonal anti-Tau antibody candidate for the treatment of prodromal to mild AD, partnered with Genentech, a member of the Roche Group. These represent the first-ever Phase 2 results for an anti-Tau antibody therapeutic in AD. Primary completion of the second Phase 2 study in moderate AD patients is expected in Q2 2021.
    • Completed a Phase 1 clinical study in healthy volunteers for ACI-3024, an oral small molecule Morphomer™ Tau aggregation inhibitor, which achieved target brain exposure. The Companies have decided to pursue other promising Tau Morphomer candidates from AC Immune's research platform for potential clinical development in AD. ACI-3024 will be further evaluated for efficacy in models of rare Tauopathies.

    Partnership milestone payments and grants

    • Received a CHF 10 million milestone payment from Eli Lilly and Company related to ACI-3024
    • Amended the collaboration agreement with Lilly for Tau Morphomers to include a new CHF 60 million Phase 2 milestone payment, which increased the total potential deal value by CHF 40 million to CHF 1.86 billion
    • Received multiple prestigious and highly competitive grants in 2020 focused on acceleration of the Company's proprietary and potentially game-changing diagnostic programs
      • Won Ken Griffin Alpha-synuclein Imaging Competition from The Michael J. Fox Foundation for Parkinson's Research (MJFF) and is able to receive together with its clinical partner USD 3.2 million (CHF 3.1 million) to support AC Immune's alpha-synuclein-PET tracers
      • Awarded a EUR 1.45 million grant to support the partnership between AC Immune and the EU Joint Programme – Neurodegenerative Disease Research (JPND) ImageTDP-43 Consortium to advance its first-in-class TAR DNA-binding protein 43 (TDP-43) PET tracers
      • Awarded a USD 600,000 grant from Target ALS to develop novel immuno-assays to detect pathological TDP-43 in cerebrospinal fluid (CSF) and blood based on AC Immune's SupraAntigen™-derived anti-TDP-43 antibodies

    Strengthening of Management and Board

    • Appointed Prof. Johannes R. Streffer, former UCB Biopharma Head of Translational Neuroscience, to the new role of Chief Medical Officer
    • Welcomed Prof. Carl H. June, world authority on immune tolerance and adoptive immunotherapy, to the Company's Board of Directors
    • Appointed renowned Neurologist with a specific focus in the emerging field of Down syndrome (DS)-related Alzheimer's disease, Dr. Juan Fortea to AC Immune's Clinical Advisory Board

    Future Value Creation

    • Reported key advancements for several therapeutic programs targeting the NLRP3 inflammasome, including small molecule inhibitors, which showed the first evidence of in vivo activity in a model of peripheral inflammation, as well as high-affinity monoclonal antibodies that bind extracellular components of the (NOD)-like receptor protein 3 (NLRP3) pathway and inhibit inflammasome-mediated immune response in vitro
    • Identified and characterized the first biologically active small molecule Morphomer alpha-synuclein aggregation inhibitors, which significantly decreased alpha-synuclein aggregate formation in cellular assays by interfering with the fibrillation process
    • Strengthened strategic partnership with WuXi Biologics to accelerate advancement of TDP-43 antibody into clinical development for NeuroOrphan indications

    2021 execution strategy to maximize value creation

    AC Immune's execution strategy is focused on three key initiatives, which support the Company's overarching goal of enabling precision medicine for neurodegenerative diseases:

    • The Company plans to accelerate the development of its late-stage therapies in AD in collaboration with its strategic partners, including its novel pTau vaccine with Janssen Pharmaceuticals Inc., which continues to show great promise.
    • AC Immune is sharpening its strategic focus on non-AD indications with high unmet need. Currently this includes its anti-Abeta vaccine in people with DS, as well as its therapeutic and diagnostic candidates targeting TDP-43 and alpha-synuclein, where the Company may focus in-house efforts on select NeuroOrphan indications while seeking potential partnerships for larger indications like LATE (limbic-predominant age-related TDP-43 encephalopathy) and Parkinson's disease (PD). Furthermore, AC Immune's NLRP3 inflammasome-targeted programs have broad applicability both within central nervous system (CNS) and non-CNS indications.
    • The Company plans to accelerate advancement of its diagnostic candidates to late-stage development, as continued leadership in precision medicine is a key differentiator for AC Immune. These candidates include its Tau, alpha-synuclein, and TDP-43 PET tracers, which potentially enable earlier disease diagnosis, improved clinical trial outcomes and additional revenue generation for the Company.

    Anticipated 2021 milestones

    Clinical Milestones

    • ACI-35.030 anti-pTau vaccine: reported Phase 1b/2a in AD interim results in Q1 (second highest dose); further Phase 1b/2a interim analysis in Q4 (highest dose)
    • JACI-35.054 alternative anti-pTau vaccine: Phase 1b/2a in AD interim analysis in Q2 (low dose)
    • Alpha-synuclein imaging agent: advanced third-generation candidate to first-in-human clinical study in Q1; readout expected in Q3
    • ACI-24 anti-Abeta vaccine in DS: reported Phase 1b top line results in Q1; to present further study results at the Alzheimer's Association International Conference® 2021 in Q2
    • ACI-24 in AD: reported Phase 2, 12-month interim analysis in Q1; 18-month interim analysis in Q2
    • Semorinemab anti-Tau antibody: Phase 2 trial primary completion (estimated last patient, last visit) in moderate AD in Q2
    • ACI-3024 small molecule Morphomer Tau aggregation inhibitor: select NeuroOrphan indication for further development in Q2
    • ACI-24 in DS: submit investigational new drug (IND) application for optimized vaccine formulation in Q4

    Preclinical Milestones

    • Alpha-synuclein small molecule inhibitor: identified first biologically active small molecule in Q1; start in vivo proof-of-concept studies in Q3
    • TDP-43 imaging agent: initiate investigational new drug (IND)-enabling studies in Q3
    • Morphomer NLRP3-ASC: report in vivo proof-of-concept results in a non-CNS disease model and begin in vivo proof-of-concept studies with validated candidate in CNS in Q4
    • Anti NLRP3-ASC antibody: begin in vivo proof-of-concept studies in Q4
    • Anti-TDP-43 antibody: initiate IND-enabling toxicology studies in Q4
    • TDP-43 biofluid diagnostic: establish validation-ready assay in Q4

    Therapeutic and Diagnostic Pipeline Overview

    AC Immune also provided a comprehensive overview highlighting strong progress across its clinical and preclinical development pipeline. This supplemental material can be viewed and downloaded in the investor section of the Company's website.

    Analysis of Financial Statements for the year ended December 31, 2020

    • Cash Position: The Company had a total cash balance of CHF 225.9 million, comprised of CHF 160.9 million in cash and cash equivalents and CHF 65 million in short-term financial assets. This compares to a total cash balance of CHF 288.6 million as of December 31, 2019. The decrease of CHF 62.7 million is principally due to continued investments in our R&D pipeline. The total shareholders' equity position decreased to CHF 215.5 million from CHF 272.4 million as of the prior year. The Company's cash balance provides enough capital resources to progress through at least Q1 2024 without potential incoming milestone payments.
    • Contract Revenues: Contract revenues for the year ended December 31, 2020 totaled CHF 15.4 million compared to CHF 110.5 million in 2019, representing a CHF 95 million decrease. The Company recognized a CHF 10 million milestone and CHF 4.3 million for research and development activities in 2020 from its Lilly agreement compared to CHF 103.1 million for an upfront payment and milestone and CHF 2.6 million for research and development activities in 2019.
    • R&D Expenditures: R&D expenses increased by CHF 9.1 million for the year ended December 31, 2020.
      • Discovery and preclinical expenses: The Company increased expenditures across a variety of its discovery and preclinical programs. These include investments to advance the second generation of our ACI-24 for Down Syndrome project, the initiation of IND-enabling studies of our anti-TDP-43 antibody project and various other investments across our alpha-synuclein and neuroinflammation programs.
      • Clinical expenses: The Company also increased expenditures across multiple Clinical programs. These include investments to prepare a follow-on trial for our Abeta vaccine for Down Syndrome project, additional enrollment costs for the Phase 1b/2a study for ACI-35.030 and a full year of clinical activities to complete the Phase 1 of our Morphomer Tau asset in partnership with Lilly.
      • Salary- and benefit-related costs: The Company's salary- and benefit-related costs increased by CHF 2.7 million, primarily due to the addition of 13 FTEs, annualization of 2019 hires and increases in share-based compensation.
    • G&A Expenditures: For the year ended December 31, 2020, G&A increased by CHF 2.5 million to 18.6 million. Of this increase, CHF 1.7 million is due to salary- and benefit-related costs, primarily due to the addition of 3 FTEs, annualization of 2019 hires and increases in share-based compensation. Additionally, the Company incurred a CHF 0.8 million increase in other G&A expenses, predominantly associated with depreciation expense, insurance and professional fees
    • IFRS Income/(Loss) for the Period: The Company reported a net loss after taxes of CHF 61.9 million for the year ended December 31, 2020, compared with net income of CHF 45.4 million for 2019

    2021 Financial Guidance 

    For the full year 2021, the Company expects its total cash burn to range between CHF 65 million ‒75 million.

    About AC Immune SA

    AC Immune SA is clinical-stage biopharmaceutical company that aims to become a global leader in precision medicine for neurodegenerative diseases, including Alzheimer's disease, Parkinson's disease, and NeuroOrphan indications driven by misfolded proteins. The Company's two clinically validated technology platforms, SupraAntigenTM and MorphomerTM, fuel its broad and diversified pipeline of first- and best-in-class assets, which currently features nine therapeutic and three diagnostic candidates, six of which are currently in clinical trials. AC Immune has a strong track record of securing strategic partnerships with leading global pharmaceutical companies including Genentech, a member of the Roche Group, Eli Lilly and Company, and Janssen Pharmaceuticals, Inc., resulting in substantial non-dilutive funding to advance its proprietary programs and >$3 billion in potential milestone payments.

    For further information, please contact:

    Head of Investor Relations

    Joshua Drumm, Ph.D.

    AC Immune

    Phone : +1 917 809 0814

    Email:
    U.S. Media

    Katie Gallagher

    LaVoie Health Science

    Phone: +1 617 792 3937

    Email:
      
     European Investors & Media

    Chris Maggos

    LifeSci Advisors

    Phone : +41 79 367 6254

    Email :

    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. 

    Balance Sheets

    (In CHF thousands)

     As of

    December 31,
     2020  2019 
    ASSETS  
    Non-current assets  
    Property, plant and equipment4,416  3,917 
    Right-of-use assets2,223  2,255 
    Long-term financial assets334  304 
    Total non-current assets6,973  6,476 
    Current assets  
    Prepaid expenses3,954  2,788 
    Accrued income1,591  1,095 
    Other current receivables329  304 
    Short-term financial assets65,000  95,000 
    Cash and cash equivalents160,893  193,587 
    Total current assets231,767  292,774 
    Total assets 238,740  299,250 
       
    SHAREHOLDERS' EQUITY AND LIABILITIES  
    Shareholders' equity  
    Share capital1,538  1,437 
    Share premium346,890  346,526 
    Treasury shares(100)  
    Accumulated losses(132,850) (75,521)
    Total shareholders' equity215,478  272,442 
       
    Non-current liabilities  
    Long-term lease liabilities1,780  1,813 
    Net employee defined benefit liabilities7,464  7,485 
    Total non-current liabilities9,244  9,298 
       
    Current liabilities  
    Trade and other payables2,184  142 
    Accrued expenses11,085  11,797 
    Deferred income306  4,477 
    Short-term financing obligation  652 
    Short-term lease liabilities443  442 
    Total current liabilities14,018  17,510 
    Total liabilities23,262  26,808 
    Total shareholders' equity and liabilities238,740  299,250 
          

     Statements of Income/(Loss)

    (In CHF thousands, except for per-share data)

     For the Years Ended

    December 31,
     2020  2019  2018 
    Revenues   
    Contract revenue15,431  110,456  6,912 
    Total revenue15,431  110,456  6,912 
        
    Operating expenses   
    Research & development expenses(59,487) (50,432) (44,277)
    General & administrative expenses(18,557) (16,058) (12,467)
    Other operating income/(expense)1,353  570  282 
        
    Total operating expenses(76,691) (65,920) (56,462)
        
    Operating income/(loss) (61,260) 44,536  (49,550)
    Financial income78  303  127 
    Financial expense(184) (1,926) (334)
    Change in fair value of conversion feature  4,542   
    Exchange differences(555) (2,013) (1,194)
    Finance result, net(661) 906  (1,401)
    Income/(loss) before tax(61,921) 45,442  (50,951)
    Income tax expense     
    Income/(loss) for the period(61,921) 45,442  (50,951)
    Earnings/(loss) per share:   
    Basic income/(loss) for the period attributable to equity holders(0.86) 0.64  (0.82)
    Diluted income/(loss) for the period attributable to equity holders(0.86) 0.64  (0.82)
             

    Statements of Comprehensive Income/(Loss)

    (In CHF thousands)

     For the Years Ended

    December 31,
     2020  2019  2018 
    Income/(loss) for the period(61,921) 45,442  (50,951)
    Other comprehensive income/(loss) not to be reclassified to income or loss in subsequent periods (net of tax)   
        
    Remeasurement income/(losses) on defined benefit plans (net of tax)726  (1,304) (302)
    Total comprehensive income/(loss), net of tax (61,195) 44,138  (51,253)
             

    Reconciliation of income/(loss) to adjusted income/(loss) and

    earnings/(loss) per share to adjusted earnings/(loss) per share

      For the Years Ended

    December 31,
    In CHF thousands, except for share and per

    share data
     2020  2019  2018 
    Income/(loss) (61,921) 45,442  (50,951)
    Adjustments:     
    Non-cash share-based payments1 4,088  2,834  2,518 
    Foreign currency (gains)/losses2 703  826  1,179 
    Effective interest expenses3   1,355   
    Change in fair value of conversion feature4   (4,542)  
    Adjusted income/(loss) (57,130) 45,915  (47,254)
          
    Earnings/(loss) per share – basic (0.86) 0.64  (0.82)
    Earnings/(loss) per share – diluted (0.86) 0.64  (0.82)
    Adjustment to earnings/(loss) per share – basic 0.07  0.01  0.06 
    Adjustment to earnings/(loss) per share – diluted 0.07  0.00  0.06 
    Adjusted earnings/(loss) per share – basic (0.79) 0.65  (0.76)
    Adjusted earnings/(loss) per share – diluted (0.79) 0.64  (0.76)
    Weighted-average number of shares used to compute adjusted loss per share – basic 71,900,212  70,603,611  61,838,228 
    Weighted-average number of shares used to compute adjusted loss per share – diluted 71,900,212  71,103,341  61,838,228 
              

    1Reflects non-cash expenses associated with share-based compensation for equity awards issued to directors, management and employees of the Company. This expense reflects the awards' fair value recognized for the portion of the equity award which is vesting over the period.

    2Reflects foreign currency re-measurement gains and losses for the period, predominantly impacted by the change in the exchange rate between the US Dollar and the Swiss Franc.

    3Effective interest expense for the period relates to the accretion of the Company's convertible loan in accordance with the effective interest method.

    4Change in fair value of conversion feature that is bifurcated from the convertible loan host debt with Lilly.

    Adjustments for the years ended December 31, 2020, 2019 and 2018 decreased net loss by CHF 4.8 million, increased net income by CHF 0.5 million and decreased net loss by CHF 3.7 million, respectively. The Company recorded share-based compensation expenses of CHF 4.1 million, CHF 2.8 million and CHF 2.5 million for the years ended December 31, 2020, 2019 and 2018, respectively. There were foreign currency re-measurement losses of CHF 0.7 million, CHF 0.8 million and CHF 1.2 million for the years ended December 31, 2020, 2019 and 2018, respectively, predominantly related to the cash balance of the Company as a result of fluctuations of the US Dollar against the Swiss Franc. Related to the Company's convertible note settled with Lilly in 2019, we recorded CHF 1.4 million for amortization of effective interest for the year ended December 31, 2019 and recognized a CHF 4.5 million gain for the change in fair value of the liability related to the conversion feature in 2019. There were no comparable expenses or gains in 2020 nor 2018.



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  4. Topline ACI-24 Phase 1b immunogenicity and safety results reported today at a global Down syndrome symposium

    Reported new data in non-human primates for optimized vaccine formulation which shows strong response against key pathological Abeta species, including oligomeric and pyroglutamate Abeta

    LAUSANNE, Switzerland, March 16, 2021 (GLOBE NEWSWIRE) -- AC Immune SA (NASDAQ:ACIU), a Swiss-based, clinical-stage biopharmaceutical company with a broad pipeline focused on neurodegenerative diseases, today announced plans to advance its novel anti-amyloid-beta (Abeta) vaccine into mid-stage clinical testing to treat and prevent the progression of Down syndrome (DS)-related Alzheimer's disease (AD). Topline results reported today by AC Immune's…

    Topline ACI-24 Phase 1b immunogenicity and safety results reported today at a global Down syndrome symposium

    Reported new data in non-human primates for optimized vaccine formulation which shows strong response against key pathological Abeta species, including oligomeric and pyroglutamate Abeta

    LAUSANNE, Switzerland, March 16, 2021 (GLOBE NEWSWIRE) -- AC Immune SA (NASDAQ:ACIU), a Swiss-based, clinical-stage biopharmaceutical company with a broad pipeline focused on neurodegenerative diseases, today announced plans to advance its novel anti-amyloid-beta (Abeta) vaccine into mid-stage clinical testing to treat and prevent the progression of Down syndrome (DS)-related Alzheimer's disease (AD). Topline results reported today by AC Immune's Chief Scientific Officer, Dr. Marie Kosco-Vilbois, at a global DS symposium co-sponsored by AC Immune, showed that ACI-24 demonstrated encouraging immunogenicity and safety in Phase 1b clinical testing in people with DS. The Company also disclosed new non-human primate data for an optimized formulation of the vaccine, which shows broad potential for the treatment and prevention of Abeta-driven diseases based on its superior efficacy in non-human primates.

    Dr. Kosco-Vilbois, commented: "As World Down Syndrome Day approaches, which is held each year on March 21st to raise awareness for the DS community, we are proud to be leading the way towards addressing a key health challenge facing those living with DS, the early development of AD symptoms. Specifically, we are advancing our anti-Abeta vaccine, which demonstrated encouraging results in a first-of-its-kind Phase 1b study in people with DS. Importantly, the successful completion of this study demonstrates the feasibility of safely testing our Abeta vaccine in individuals with DS. The trial resulted in a very high retention rate with no early withdrawals, at any dose, during the treatment period. We look forward to continuing clinical development in order to potentially offer an effective vaccine strategy to treat, and perhaps ultimately prevent, the development of AD in individuals with DS."

    Highlights from the Phase 1b study in DS-related AD

    • Vaccination of adults with DS with ACI-24 resulted in encouraging immunogenicity (generation of anti-Abeta antibodies)
    • A positive pharmacodynamic response was observed, as measured by an increase in plasma Abeta
    • ACI-24 was safe and well tolerated with no serious adverse events (SAEs) reported
    • There was no evidence of central nervous system (CNS) inflammation, meningoencephalitis, or ARIA (amyloid-related imaging abnormalities), including ARIA-E (-edema) and ARIA-H (-hemorrhage)
    • AC Immune plans to present the full Phase 1b study results at the upcoming Alzheimer's Association International Conference (AAIC)

    Due to the high vulnerability of people with DS to severe COVID-19 sequelae, initiation of the next clinical trial will be delayed to ensure the safety of study participants. In the interim, AC Immune is taking advantage of this time to accelerate development of its optimized anti-Abeta vaccine formulation, which demonstrated encouraging safety and superior immunogenicity results in mouse and non-human primate (NHP) studies. Dr. Kosco-Vilbois presented some of these key findings during her presentation today:

    Key preclinical results for the optimized anti-Abeta vaccine formulation in NHPs

    • The optimized vaccine formulation primes, boosts, and maintains strong anti-Abeta antibody responses in two NHP species
    • The optimized vaccine formulation generates conformation-specific antibodies targeting key pathological Abeta species, including oligomeric and pyroglutamate Abeta
    • The antibodies elicited by the optimized vaccine formulation in NHPs showed clear target engagement by binding to human Abeta plaques on AD patient-derived brain tissue

    ACI-24 is also currently being tested in a Phase 2 clinical trial in patients with mild AD. In this study, there have been no safety concerns nor evidence for CNS inflammation or ARIA related to ACI-24 in any subject. The Phase 2 study is progressing toward an 18-month interim analysis, which is planned for Q2 2021.

    Prof. Andrea Pfeifer, CEO of AC Immune SA, commented: "There is broad potential for our optimized Abeta vaccine formulation across Abeta-driven diseases, including DS-related, genetic, and sporadic AD. We plan to complete the current Phase 2 study in mild AD and, in line with our proven business strategy, seek a strategic partner for further development for AD in the general population. This allows us to focus our in-house efforts on advancing our vaccine into later-stage clinical development to address genetically defined AD in people with DS. We look forward to initiating a follow-on clinical trial in DS as soon as the threat to this vulnerable patient population from COVID-19 subsides. In the interim, we are in discussions with the FDA on a potentially accelerated development pathway for the optimized vaccine formulation and expect to file an investigational new drug application for the new formulation in Q4 2021. In parallel, we are encouraged by the recent data from Abeta therapeutic antibodies in AD and expect our optimized vaccine formulation data showing strong responses against pathological oligomeric and pyroglutamate Abeta to further support ongoing clinical development in large and NeuroOrphan indications."

    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, SupraAntigen™ and Morphomer™, 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 Genentech, a member of the Roche Group, Eli Lilly and Company and Janssen Pharmaceuticals Inc.

    For further information, please contact:

    Head of Investor Relations

    Joshua Drumm, Ph.D.

    AC Immune

    Phone: +1 917 809 0814

    Email:



    US Media

    Katie Gallagher

    LaVoie Health Science

    Phone: +1 617 792 3937

    Email:



     European Investors & Media

    Chris Maggos

    LifeSci Advisors

    Phone: +41 79 367 6254

    Email:

    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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  5. Four presentations at AD/PD™ 2021 feature latest findings from wholly owned therapeutic and diagnostic programs targeting pathological forms of alpha-synuclein and TDP-43

    First biologically active small molecule inhibitors of intracellular alpha-synuclein aggregation advancing toward in vivo proof-of-concept studies

    Anti-TDP-43 therapeutic antibody candidates demonstrate dual mechanism of action against pathological TDP-43 in vivo

    LAUSANNE, Switzerland, March 09, 2021 (GLOBE NEWSWIRE) -- AC Immune SA (NASDAQ:ACIU), a Swiss-based, clinical-stage biopharmaceutical company with a broad pipeline focused on neurodegenerative diseases, today outlined new preclinical data that will be presented at the 15th International Conference on Alzheimer's…

    Four presentations at AD/PD™ 2021 feature latest findings from wholly owned therapeutic and diagnostic programs targeting pathological forms of alpha-synuclein and TDP-43

    First biologically active small molecule inhibitors of intracellular alpha-synuclein aggregation advancing toward in vivo proof-of-concept studies

    Anti-TDP-43 therapeutic antibody candidates demonstrate dual mechanism of action against pathological TDP-43 in vivo

    LAUSANNE, Switzerland, March 09, 2021 (GLOBE NEWSWIRE) -- AC Immune SA (NASDAQ:ACIU), a Swiss-based, clinical-stage biopharmaceutical company with a broad pipeline focused on neurodegenerative diseases, today outlined new preclinical data that will be presented at the 15th International Conference on Alzheimer's & Parkinson's Diseases (AD/PD™), taking place virtually from March 9–14, 2021. Data from the Company's wholly owned, first-in-class therapeutic and diagnostic programs targeting pathological forms of alpha-synuclein and TAR DNA-binding protein 43 (TDP-43) are described during four oral and e-poster presentations. Together the presentations further illustrate the synergy between AC Immune's SupraAntigen™ and Morphomer™ technology platforms to deliver a precision medicine approach to treating neurodegenerative diseases (NDD).

    Alpha-synuclein and TDP-43 are hallmarks of major NDD such as Parkinson's disease and limbic-predominant age-related TDP-43 encephalopathy (LATE), respectively, and are well-recognized co-pathologies in Alzheimer's disease linked to accelerated cognitive decline. AC Immune targets pathological forms of these proteins with highly specific antibody and small molecule therapeutics, as well as first-in-class positron emission tomography (PET) diagnostic candidates, which are amongst the most advanced in the field.

    Prof. Andrea Pfeifer, CEO of AC Immune SA, commented: "We continue to expand our position as a global leader in precision medicine for neurodegenerative diseases by leveraging our Morphomer™ and SupraAntigen™ platforms to discover and advance first-in-class therapeutics in parallel with companion diagnostics. Our approach informs and enables targeting the right proteinopathies, in the right patient, at the right time, and provides a pathway toward tailored combination therapies in the future. In addition to our pipeline targeting amyloid-beta and Tau pathologies, the alpha-synuclein and TDP-43 programs highlighted in our AD/PD™ presentations are crucial components of such an approach, as these proteins have recently emerged as key targets across a multitude of neurodegenerative diseases."

    Prof. Pfeifer continued: "In vivo characterization of our next-generation alpha-synuclein PET tracer candidate further illustrates its strong diagnostic profile, and we anticipate reporting the first clinical results from this potentially game-changing program in the third quarter of this year. Success in this exciting program could greatly accelerate the advancement of therapeutics for Parkinson's disease and other alpha-synucleinopathies, including our first-in-class alpha-synuclein aggregation inhibitors, by enabling accurate diagnosis, patient selection and longitudinal drug efficacy measurement based on changes in alpha-synuclein pathology in the brain. This precision medicine approach is mirrored by our TDP-43 antibody and PET tracer programs, for which we've also demonstrated highly encouraging therapeutic and diagnostic potential."

    Details of AC Immune's AD/PD™ 2021 presentations

    Morphomer™ TDP-43 imaging

    First-in-class TDP-43 PET tracers were characterized using a newly optimized radiobinding assay, which enabled the identification of several distinct chemical series of promising Morphomers™ that bind to recombinant and brain-derived TDP-43 aggregates. Selected compounds also demonstrate direct target engagement on patient-derived brain tissue, as assessed by a positive signal in a proprietary high-resolution autoradiography assay that co-localized with pathological TDP-43. Medicinal chemistry is ongoing to further optimize the properties of hit compounds, and investigational new drug (IND)-enabling studies are expected to begin in Q3 2021.

    Title: Discovery of PET tracers for TDP-43 proteinopathies

    Date: Thursday, March 11, 2021 | 10:45 – 11:00 am CET

    Presenter: Oral presentation by Tamara Seredenina

    Anti-TDP-43 antibody

    Data to be presented show that AC Immune's lead anti-TDP-43 antibody, the first with reported in vivo activity, significantly reduced levels of pathological (phosphorylated or insoluble) forms of TDP-43 in the brain in a murine neurodegenerative disease model. New data also demonstrate the antibody's dual mechanism of action, showing that it inhibits TDP-43 aggregation and promotes the uptake and clearance of pre-existing TDP-43 aggregates by microglia. The lead candidate is currently in IND-enabling studies and is expected to start preclinical toxicology studies by year end.

    Title: TDP-43 antibody directed microglial clearance and inhibition of seeded aggregation mitigates neuropathology in models of TDP-43 proteinopathy

    Date: Thursday, March 11, 2021 | 11:15 – 11:30 am CET

    Presenter: Oral presentation by Tariq Afroz

    Morphomer™ alpha-synuclein imaging

    New preclinical data for ACI-12589, a next-generation alpha-synuclein PET tracer being developed as a first-in-class diagnostic imaging agent for Parkinson's disease and other alpha-synucleinopathies, confirm that the Morphomer™-derived candidate has a desirable brain-PET ligand pharmacokinetic profile in non-human primates. ACI-12589 has previously shown excellent target engagement and signal specificity on tissue samples from patients with alpha-synucleinopathies, including Parkinson's disease, multiple system atrophy (MSA) and dementia with Lewy bodies (DLB). ACI-12589 is currently being evaluated in a first-in-human study.

    Title: [18F]ACI-12589, a novel alpha-synuclein radiotracer as a biomarker in patients with Parkinson's disease and other synucleinopathies

    E-poster ID: P531 / #868

    Presenter: E-poster presentation by Efthymia Vokali

    Morphomer™ alpha-synuclein small molecule aggregation inhibitor

    The first biologically active small molecule inhibitors targeting intracellular alpha-synuclein aggregates have been identified using the Morphomer™ platform. Data to be presented for the first time show that these initial compounds, from several distinct chemical series, significantly decrease alpha-synuclein aggregate formation in cellular assays by interfering with the fibrillation process. Iterative medicinal chemistry optimization led to the identification of compounds with favorable CNS-penetrant pharmacokinetic properties, which will be progressed into in vivo proof-of-concept studies in models of alpha-synucleinopathies, expected to begin in Q3 2021.

    Title: Generating a first in class inhibitor to treat Parkinson's disease by targeting intracellular alpha-synuclein pathology

    E-poster ID: P425 / #1195

    Presenter: E-poster presentation by Nadine Aït-Bouziad

    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, SupraAntigen™ and Morphomer™, 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 Genentech, a member of the Roche Group, Eli Lilly and Company and Janssen Pharmaceuticals.

      

    For further information, please contact:

    Head of Investor Relations

    Joshua Drumm, Ph.D.

    AC Immune

    Phone: +1 917 809 0814

    Email:



    US Media

    Katie Gallagher

    LaVoie Health Science

    Phone: +1 617 792 3937

    Email:



     European Investors & Media

    Chris Maggos

    LifeSci Advisors

    Phone: +41 79 367 6254

    Email:

    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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  6. LAUSANNE, Switzerland, Feb. 24, 2021 (GLOBE NEWSWIRE) -- AC Immune SA (NASDAQ:ACIU), a Swiss-based, clinical-stage biopharmaceutical company with a broad pipeline focused on neurodegenerative diseases, today announced that four new data presentations will be delivered at the 15th International Conference on Alzheimer's & Parkinson's Diseases (AD/PDTM), taking place virtually from March 9–14, 2021. The presentations will highlight preclinical results from the Company's wholly-owned therapeutic and diagnostic programs targeting pathological forms of alpha-synuclein and TAR DNA-binding protein 43 (TDP-43) for neurodegenerative diseases.

    The presentations will showcase how AC Immune's expertise in discovery, assay development and characterization…

    LAUSANNE, Switzerland, Feb. 24, 2021 (GLOBE NEWSWIRE) -- AC Immune SA (NASDAQ:ACIU), a Swiss-based, clinical-stage biopharmaceutical company with a broad pipeline focused on neurodegenerative diseases, today announced that four new data presentations will be delivered at the 15th International Conference on Alzheimer's & Parkinson's Diseases (AD/PDTM), taking place virtually from March 9–14, 2021. The presentations will highlight preclinical results from the Company's wholly-owned therapeutic and diagnostic programs targeting pathological forms of alpha-synuclein and TAR DNA-binding protein 43 (TDP-43) for neurodegenerative diseases.

    The presentations will showcase how AC Immune's expertise in discovery, assay development and characterization of promising candidates powers its industry-leading pipeline. Two oral presentations will highlight the Company's first-in-class positron emission tomography (PET) imaging agent and therapeutic antibody programs targeting TDP-43 proteinopathies, and two electronic poster presentations will focus on AC Immune's novel small molecule aggregation inhibitor and clinical-stage PET imaging agent for alpha-synuclein.

    Prof. Andrea Pfeifer, CEO of AC Immune SA, commented: "Our presentations at AD/PDTM further demonstrate how we leverage our MorphomerTM and SupraAntigenTM platforms to generate highly differentiated candidates and enable our precision medicine approach to neurodegenerative diseases. We are advancing proprietary therapeutics in unison with first-in-class companion diagnostics, such as our novel alpha-synuclein PET tracer candidate, ACI-12589, which is being evaluated in an ongoing First-in-Human study. Our unique combination of highly selective diagnostic and therapeutic candidates could allow optimal targeting of key proteinopathies and enable major advances in areas of unmet medical need."

    Scientific updates at AD/PDTM 2021

    Morphomer™ TDP-43 imaging

    Title: Discovery of PET tracers for TDP-43 proteinopathies

    Date: Thursday, March 11, 2021 | 10:45 – 11:00 am CET

    Presenter: Oral presentation by Tamara Seredenina

    Anti-TDP-43 antibody

    Title: TDP-43 antibody directed microglial clearance and inhibition of seeded aggregation mitigates neuropathology in models of TDP-43 proteinopathy

    Date: Thursday, March 11, 2021 | 11:15 – 11:30 am CET

    Presenter: Oral presentation by Tariq Afroz

    Morphomer™ alpha-synuclein imaging

    Title: [18F]ACI-12589, a novel alpha-synuclein radiotracer as a biomarker in patients with Parkinson's disease and other synucleinopathies

    E-poster ID: P531 / #868

    Presenter: E-poster presentation by Efthymia Vokali

    Morphomer™ alpha-synuclein small molecule aggregation inhibitor

    Title: Generating a first-in-class inhibitor to treat Parkinson's disease by targeting intracellular alpha-synuclein pathology

    E-poster ID: P425 / #1195

    Presenter: E-poster presentation by Nadine Aït-Bouziad

    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 Genentech, a member of the Roche Group, Eli Lilly and Company and Janssen Pharmaceuticals.

    For further information, please contact:

    Head of Investor Relations

    Joshua Drumm, Ph.D.

    AC Immune

    Phone: +1 917 809 0814

    Email:



    US Media

    Katie Gallagher

    LaVoie Health Science

    Phone: +1 617 792 3937

    Email:



     European Investors & Media

    Chris Maggos

    LifeSci Advisors

    Phone: +41 79 367 6254

    Email:

    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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  7. LAUSANNE, Switzerland, Feb. 17, 2021 (GLOBE NEWSWIRE) -- AC Immune SA (NASDAQ:ACIU), a Swiss-based, clinical-stage biopharmaceutical company with a broad pipeline focused on neurodegenerative diseases, today announced that it will participate in the upcoming SVB Leerink 10th Annual Global Healthcare Conference, taking place virtually on February 22–26, 2021.

    During a fireside chat, AC Immune CEO Prof. Andrea Pfeifer will discuss the Company's execution strategy to advance and accelerate its precision medicine approach to targeting neurodegenerative diseases. Prof. Pfeifer will also highlight AC Immune's novel anti-phospho-Tau (pTau) vaccine candidate ACI-35.030, including recent interim Phase 1b/2a results that showed promising immunogenicity…

    LAUSANNE, Switzerland, Feb. 17, 2021 (GLOBE NEWSWIRE) -- AC Immune SA (NASDAQ:ACIU), a Swiss-based, clinical-stage biopharmaceutical company with a broad pipeline focused on neurodegenerative diseases, today announced that it will participate in the upcoming SVB Leerink 10th Annual Global Healthcare Conference, taking place virtually on February 22–26, 2021.

    During a fireside chat, AC Immune CEO Prof. Andrea Pfeifer will discuss the Company's execution strategy to advance and accelerate its precision medicine approach to targeting neurodegenerative diseases. Prof. Pfeifer will also highlight AC Immune's novel anti-phospho-Tau (pTau) vaccine candidate ACI-35.030, including recent interim Phase 1b/2a results that showed promising immunogenicity and safety in patients with early Alzheimer's disease. AC Immune is developing ACI-35.030 in collaboration with its strategic partner Janssen Pharmaceuticals, Inc.

    SVB Leerink 10th Annual Global Healthcare Conference

    Date: February 24, 2020 | 11:20–11:50 am ET / 5:20–5:50 pm CET

    Format: Fireside chat

    Presenter: Prof. Andrea Pfeifer, CEO, AC Immune SA

    A webcast of the fireside chat will be available on the Events Page of AC Immune's website.

    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 Genentech, a member of the Roche Group, Eli Lilly and Company and Janssen Pharmaceuticals.

    For further information, please contact:

    Head of Investor Relations

    Joshua Drumm, Ph.D.

    AC Immune

    Phone: +1 917 809 0814

    Email:



    US Media

    Katie Gallagher

    LaVoie Health Science

    Phone: +1 617 792 3937

    Email:



     European Investors & Media

    Chris Maggos

    LifeSci Advisors

    Phone: +41 79 367 6254

    Email:

    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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  8. Interim results of ACI-35.030 vaccination show high titers of antigen-specific antibodies at potentially therapeutic levels in 100% of older patients with early Alzheimer's disease

    ACI-35.030 was safe and well tolerated with no safety concerns observed. Results support plans to further develop the Alzheimer's vaccine into Phase 2/3

    LAUSANNE, Switzerland, Feb. 11, 2021 (GLOBE NEWSWIRE) -- AC Immune SA (NASDAQ:ACIU), a Swiss-based, clinical-stage biopharmaceutical company with a broad pipeline focused on neurodegenerative diseases, today announced positive interim results from its ongoing Phase 1b/2a clinical trial evaluating its first-in-class anti-phospho-Tau (pTau) vaccine candidate ACI-35.030 for the treatment of Alzheimer's disease (AD…

    Interim results of ACI-35.030 vaccination show high titers of antigen-specific antibodies at potentially therapeutic levels in 100% of older patients with early Alzheimer's disease

    ACI-35.030 was safe and well tolerated with no safety concerns observed. Results support plans to further develop the Alzheimer's vaccine into Phase 2/3

    LAUSANNE, Switzerland, Feb. 11, 2021 (GLOBE NEWSWIRE) -- AC Immune SA (NASDAQ:ACIU), a Swiss-based, clinical-stage biopharmaceutical company with a broad pipeline focused on neurodegenerative diseases, today announced positive interim results from its ongoing Phase 1b/2a clinical trial evaluating its first-in-class anti-phospho-Tau (pTau) vaccine candidate ACI-35.030 for the treatment of Alzheimer's disease (AD). ACI-35.030 vaccination generated a potent antigen-specific antibody response against pTau in 100% of older patients with early AD, achieving antibody levels several orders of magnitude higher than pre-vaccination levels. No clinically relevant adverse events were observed. AC Immune and strategic partner Janssen Pharmaceuticals, Inc., believe these interim findings from the first two dosing groups support plans to advance the development of ACI-35.030 for the treatment of AD.

    Immunization with anti-Tau vaccines represents a novel strategy for the treatment of AD and other neurodegenerative diseases characterized by Tau pathology. ACI-35.030 is a first-in-class vaccine candidate designed to generate a specific antibody response against pTau proteins in the brain. Anti-pTau antibodies generated by ACI-35.030 have the potential to reduce the spread and seeding of Tau pathology, which is a major hallmark of AD.

    These new results provide encouraging clinical support for ACI-35.030, which employs a new vaccine formulation to achieve active immunization that significantly improves antibody responses in older patients with potentially attenuated immune systems. Notably, anti-pTau vaccination generates antibody responses with pharmacokinetic characteristics and target epitopes that differ substantially from the Company's anti-Tau monoclonal antibody semorinemab, highlighting the comprehensive and complementary nature of AC Immune's anti-Tau pipeline.

      

    Prof. Andrea Pfeifer, CEO of AC Immune SA, commented: "These remarkable data show that ACI-35.030 is capable of generating unprecedented antibody responses against pTau in an elderly population, with very high antigen-specific titers. Importantly, it generated a much stronger antibody response compared to direct injection of exogenous antibodies. As pathological pTau is present as a precursor many years before Tau accumulation in the brain is detectable via brain imaging, such results highlight the significant promise of ACI-35.030 as an early intervention for AD, especially when combined with cutting-edge pTau diagnostics that would enable identification of people at risk of developing Tau-driven disease. We look forward to continuing to advance ACI-35.030 in our collaboration with Janssen Pharmaceuticals, Inc., as we aim to bring this potentially breakthrough vaccine to patients."

    Interim data from the Phase 1b/2a study showed:

    • Anti-Tau IgG response preferentially targets phosphorylated Tau in all patients; 
    • 100% of patients demonstrated an anti-pTau IgG response after the 1st injection for both lowest and second highest dosages;
    • Very high anti-pTau IgG titers observed following injection;
    • Anti-pTau IgM response was also elicited in all patients for both doses;
    • ACI-35.030 was safe and well tolerated with no clinically relevant safety concerns observed to date.

    The companies plan to advance to the third and highest dosing group, per the study protocol.

    ACI-35.030 is derived from AC Immune's proprietary SupraAntigenTM platform, which accelerates the discovery and development of conformation specific antibodies and vaccine candidates to power successful therapeutic and diagnostic approaches. Additional clinical-stage candidates derived from this platform include ACI-24, a proprietary anti-amyloid beta (Abeta) vaccine, crenezumab, an anti-Abeta monoclonal antibody, and semorinemab, an anti-Tau monoclonal antibody, which is in Phase 2 development for the treatment of moderate AD.

    AC Immune's SupraAntigenTM platform has also more recently generated conformation-specific antibodies against emerging neurodegenerative disease targets such as alpha-synuclein, TDP-43 and the NLRP3 inflammasome pathway. AC Immune's programs directed against these emerging targets are among the most advanced and comprehensive in the field.

    About the Phase 1b/2a pTau AD Vaccine Trial

    AC Immune's Phase 1b/2a pTau AD vaccine trial is a randomized, multicenter, double-blind, placebo-controlled clinical study with a primary objective to assess the safety, tolerability and immunogenicity of different doses of ACI-35.030 over a 48-week treatment phase in 32 patients with early AD. Other endpoints will assess clinical and cognitive parameters as well as additional immunogenicity and safety parameters.

    About ACI-35.030

    ACI-35.030 is a potent liposomal anti-pTau active investigational vaccine designed to elicit antibodies against phosphorylated pathological Tau protein. It is designed to reduce and facilitate the clearance of related Tau aggregates, slowing the progression of Tau-pathology and/or treating the underlying Tauopathy.

    It builds on the success of AC Immune's ACI-35 vaccine, which demonstrated an early target-specific antibody response against pTau after the first injection in the vast majority of participants in a Phase 1b study in mild-to-moderate AD. In preclinical studies, ACI-35.030 retained the excellent non-clinical safety profile and the highly specific antibody response against phosphorylated pathological Tau produced by ACI-35, while demonstrating an enhanced and more homogeneous antibody response.

    AC Immune is developing the ACI-35.030 vaccine in collaboration with Janssen Pharmaceuticals, Inc., under a 2014 licensing agreement to develop and commercialize therapeutic anti-Tau vaccines for the treatment of AD and potentially other Tauopathies.

    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 Genentech, a member of the Roche Group, Eli Lilly and Company and Janssen Pharmaceuticals.

    For further information, please contact:

    Head of Investor Relations

    Joshua Drumm, Ph.D.

    AC Immune

    Phone: +1 917 809 0814

    Email:

    US Media

    Katie Gallagher

    LaVoie Health Science

    Phone: +1 617 792 3937

    Email:

      
     European Investors & Media

    Chris Maggos

    LifeSci Advisors

    Phone: +41 79 367 6254

    Email:

    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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  9. LAUSANNE, Switzerland, Feb. 08, 2021 (GLOBE NEWSWIRE) -- AC Immune SA (NASDAQ:ACIU), a Swiss-based, clinical-stage biopharmaceutical company with a broad pipeline focused on neurodegenerative diseases, today announced that the first patient has been scanned in a first-in-human study of its novel diagnostic agent for Parkinson's disease (PD). ACI-12589 is a next-generation positron emission tomography (PET) imaging tracer that has shown significant potential to reliably detect and map deposits of pathological alpha-synuclein protein in the brain, which is the major hallmark of PD. AC Immune expects to report the results of the study in Q3 2021. The clinical study is supported by the Michael J. Fox Foundation for Parkinson's Research (MJFF…

    LAUSANNE, Switzerland, Feb. 08, 2021 (GLOBE NEWSWIRE) -- AC Immune SA (NASDAQ:ACIU), a Swiss-based, clinical-stage biopharmaceutical company with a broad pipeline focused on neurodegenerative diseases, today announced that the first patient has been scanned in a first-in-human study of its novel diagnostic agent for Parkinson's disease (PD). ACI-12589 is a next-generation positron emission tomography (PET) imaging tracer that has shown significant potential to reliably detect and map deposits of pathological alpha-synuclein protein in the brain, which is the major hallmark of PD. AC Immune expects to report the results of the study in Q3 2021. The clinical study is supported by the Michael J. Fox Foundation for Parkinson's Research (MJFF), building on The Foundation's significant funding of AC Immune's program since 2015.

    Alpha-synuclein misfolding and aggregation are the molecular basis for the formation of pathological Lewy bodies and neurites, which are characteristic of PD and other alpha-synucleinopathies such as multiple system atrophy (MSA) and Lewy body dementia (LBD). In preclinical studies, ACI-12589 demonstrates significantly improved target occupancy and binds to PD patient-derived tissue with improved sensitivity and specificity compared to AC Immune's prior-generation candidates. These favorable characteristics highlight the significant potential of ACI-12589 to become the world's first diagnostic tool for assessing brain alpha-synuclein pathology in PD. An effective diagnostic may enable accurate, potentially earlier diagnosis as well as monitoring of disease progression to facilitate longitudinal drug efficacy measurements in patients.

      

    Prof. Andrea Pfeifer, CEO of AC Immune SA, commented: "The unmet need for reliable, non-invasive diagnostic tools to enable precision medicine approaches in Parkinson's disease is substantial, which is why our alpha-synuclein PET tracer program is so critical for the field. While inclusions containing misfolded aggregates of this key protein have long been considered an important neuropathology in this debilitating neurodegenerative disease, the means to accurately detect and quantify pathological alpha-synuclein in the brain has remained elusive. With our next-generation PET tracer candidate, we believe there is potential to change this paradigm. ACI-12589 demonstrates ideal properties in preclinical studies using patient-derived brain tissue, which is another testament to the strength of our Morphomer™ platform and the medicinal chemistry expertise at AC Immune. We are pleased to have the continued support of the MJFF as we enter the clinic with this promising diagnostic candidate, which, together with our novel therapeutic candidates targeting pathological alpha-synuclein, encapsulate our precision medicine approach to neurodegenerative diseases."

    AC Immune's PET tracers are derived from the Company's innovative Morphomer technology platform, which accelerates the design, development and synthesis of conformation-specific, CNS- and cell-penetrant small molecules to power successful diagnostic and therapeutic approaches. The Morphomer™ platform has produced multiple small molecules that have been validated in clinical studies, including both therapeutic and diagnostic candidates that selectively target pathological forms of Tau protein. In addition to ACI-12589, AC Immune is advancing Morphomer-derived small molecule aggregation inhibitors that significantly decrease alpha-synuclein aggregate formation in cellular assays with favorable pharmacokinetic properties for further evaluation in vivo.

    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 Genentech, a member of the Roche Group, Eli Lilly and Company and Janssen Pharmaceuticals.

    For further information, please contact:

    Head of Investor Relations

    Joshua Drumm, Ph.D.

    AC Immune

    Phone: +1 917 809 0814

    Email:

    US Media

    Katie Gallagher

    LaVoie Health Science

    Phone: +1 617 792 3937

    Email:

      
     European Investors & Media

    Chris Maggos

    LifeSci Advisors

    Phone: +41 79 367 6254

    Email:

    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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  10. Highly potent in vivo anti-inflammatory activity demonstrated for novel small molecule NLRP3 inhibitors

    High-affinity antibodies against extracellular components of the inflammasome pathway show inhibition of target inflammatory responses

    LAUSANNE, Switzerland, Jan. 29, 2021 (GLOBE NEWSWIRE) -- AC Immune SA (NASDAQ:ACIU), a Swiss-based, clinical-stage biopharmaceutical company with a broad pipeline focused on neurodegenerative diseases, today announced recent advancements in its small molecule- and antibody-based therapeutic programs targeting the (NOD)-like receptor protein 3 (NLRP3) inflammasome, a multi-protein complex that activates downstream inflammatory pathways leading to neuronal damage. The inflammasome is a highly valued therapeutic…

    Highly potent in vivo anti-inflammatory activity demonstrated for novel small molecule NLRP3 inhibitors

    High-affinity antibodies against extracellular components of the inflammasome pathway show inhibition of target inflammatory responses

    LAUSANNE, Switzerland, Jan. 29, 2021 (GLOBE NEWSWIRE) -- AC Immune SA (NASDAQ:ACIU), a Swiss-based, clinical-stage biopharmaceutical company with a broad pipeline focused on neurodegenerative diseases, today announced recent advancements in its small molecule- and antibody-based therapeutic programs targeting the (NOD)-like receptor protein 3 (NLRP3) inflammasome, a multi-protein complex that activates downstream inflammatory pathways leading to neuronal damage. The inflammasome is a highly valued therapeutic target implicated in a wide range of neurodegenerative disorders including Alzheimer's disease (AD), as well as in non-central nervous system (CNS) indications, such as autoimmune and infectious diseases, as well as certain cancers.

    Leveraging the know-how of its proprietary Morphomer™ platform, which generated AC Immune's clinical stage small molecule Tau aggregation inhibitors, the Company has successfully identified, and filed patent applications for, various chemical series of potent small molecule NLRP3 inhibitors. AC Immune has established biological activity for these compounds in multiple functional assays, and initial animal studies show highly potent target inhibition in a model of peripheral inflammation, providing the first evidence of in vivo activity. AC immune is currently evaluating potential lead compounds for further in vivo efficacy and CNS delivery. The Company expects to initiate in vivo proof-of-concept studies for a CNS-optimized lead compound for development in AD and other key neurodegenerative diseases by year end, as well as evaluate the potential of a second lead molecule in a clinically relevant non-CNS disease model.

    A critical component of the NLRP3 pathway is ASC (apoptosis-associated speck-like protein containing a C-terminal caspase recruitment domain), which is released by immune cells following NLRP3 inflammasome activation. ASC interacts with amyloid beta (Abeta) in Alzheimer's disease, not only increasing aggregation but also inducing seeding and spreading of Abeta pathology. AC Immune's SupraAntigen™ platform has successfully generated high-affinity antibodies binding extracellular human ASC and potently inhibiting ASC-mediated inflammatory responses in vitro. Selected antibodies will be further evaluated in in vivo proof-of-concept studies using animal models of human disease, which AC Immune expects to start by year end.

    Prof. Andrea Pfeifer, CEO of AC Immune SA, commented: "Accelerating our complementary programs targeting the NLRP3 pathway intra- and extracellularly is a core element of our growth execution strategy in 2021 and beyond. These critical pipeline advancements represent substantial potential value, as the inflammasome has become an important target in both CNS and non-CNS indications. As we continue to develop our small molecule and antibody candidates, I would like to recognize the talent and dedication of our team for establishing a viable development path and enabling us to reach these milestones. Advancing multiple high-value assets targeting the inflammasome pathway further demonstrates AC Immune's ambition to shape a comprehensive pipeline addressing key targets in neurodegeneration. We look forward to providing further updates as our NLRP3 programs progress towards clinical development."

    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 Genentech, a member of the Roche Group, Eli Lilly and Company and Janssen Pharmaceuticals.

    For further information, please contact:

    Head of Investor Relations

    Joshua Drumm, Ph.D.

    AC Immune

    Phone: +1 917 809 0814

    Email:



    US Media

    Katie Gallagher

    LaVoie Health Science

    Phone: +1 617 792 3937

    Email:



     European Investors & Media

    Chris Maggos

    LifeSci Advisors

    Phone: +41 79 367 6254

    Email:



    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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  11. Grant provides USD 600,000 in funding to support a world-class collaboration between AC Immune and Massachusetts General Hospital

    Proprietary SupraAntigenTM platform continues to accelerate development of first- and best-in class antibody therapeutics and diagnostics for neurodegenerative diseases

    LAUSANNE, Switzerland, Dec. 15, 2020 (GLOBE NEWSWIRE) -- AC Immune SA (NASDAQ:ACIU), a Swiss-based, clinical-stage biopharmaceutical company with a broad pipeline focused on neurodegenerative diseases, today announced the receipt of a highly competitive grant awarded by Target ALS. The grant, which was awarded in response to the organization's call for new industry-led biomarker consortia projects, will support a world-class collaboration between…

    Grant provides USD 600,000 in funding to support a world-class collaboration between AC Immune and Massachusetts General Hospital

    Proprietary SupraAntigenTM platform continues to accelerate development of first- and best-in class antibody therapeutics and diagnostics for neurodegenerative diseases

    LAUSANNE, Switzerland, Dec. 15, 2020 (GLOBE NEWSWIRE) -- AC Immune SA (NASDAQ:ACIU), a Swiss-based, clinical-stage biopharmaceutical company with a broad pipeline focused on neurodegenerative diseases, today announced the receipt of a highly competitive grant awarded by Target ALS. The grant, which was awarded in response to the organization's call for new industry-led biomarker consortia projects, will support a world-class collaboration between AC Immune and Investigators at the Healey Center for ALS at Massachusetts General Hospital to accelerate the development of the Company's proprietary immuno-assays to detect disease-associated forms of TAR DNA-binding protein 43 (TDP-43) in cerebrospinal fluid and blood samples.

    The pathological aggregation of TDP-43 is strongly associated with motor and cognitive decline and episodic memory loss in several neurodegenerative diseases including amyotrophic lateral sclerosis (ALS), frontotemporal lobar degeneration with TDP-43 pathology (FTLD-TDP) and limbic-predominant age-related TDP-43 encephalopathy (LATE). AC Immune's SupraAntigenTM-based detection assays for aggregation-prone forms of TDP-43 in biofluids have the potential to serve as an early-stage diagnostic that may enable the development of precision medicine approaches for these diseases as well as Alzheimer's disease (AD), where pathological aggregation of TDP-43 has emerged as an important co-pathology linked to disease severity.

    Prof. Andrea Pfeifer, CEO of AC Immune SA, commented: "This award provides further validation for our comprehensive diagnostic and therapeutic programs targeting pathological TDP-43, which represents a key component of our broad and industry-leading pipeline. Our proprietary TDP-43 immuno-assays have shown great promise, with data highlighting their high sensitivity and large dynamic range for total and phosphorylated TDP-43. The recognition of this program has mirrored that offered to our first-in-class TDP-43 positron emission tomography (PET)-tracer, which recently received a €1.45M grant from the European Union."

    "These activities, together with the development of our anti-TDP-43 therapeutic antibody, which we expect to be the first therapeutic in its class to enter clinical trials, reinforce AC Immune's position as a leader in developing precision medicine-based approaches towards the treatment of neurodegenerative diseases. Additional programs advancing both therapeutics and diagnostics against targets such as Tau and alpha-synuclein highlight the comprehensive nature of this approach, which is crucial given the increasing recognition that neurodegenerative diseases are driven by a complex interplay of pathologies. The effective treatment of these diseases is thus likely to require combination therapies that are informed and enabled by novel diagnostics and therapeutics able to target specific proteinopathies."

    AC Immune's proprietary immuno-assays utilize anti-TDP-43 antibodies derived from the Company's innovative SupraAntigenTM platform, which accelerates the discovery and development of conformation-specific antibodies to successful diagnostic and therapeutic approaches. The SupraAntigenTM platform has produced multiple antibodies that bind selectively to pathological forms of human proteins involved in neurodegenerative disease such as Tau, Abeta, TDP-43, alpha-synuclein and NLRP3-ASC. This grant will accelerate the development AC Immune's anti-pTDP-43 immuno-assay to enable ex vivo diagnostic tests capable of identifying early stages of TDP-43 related diseases such as ALS. Such diagnostic tests may facilitate the effective treatment of these diseases.

    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 Genentech, a member of the Roche Group, Eli Lilly and Company and Janssen Pharmaceuticals.

    About Target ALS

    Target ALS is a 501(c)(3) medical research foundation committed to the search for effective treatments for Amyotrophic Lateral Sclerosis (ALS), also known as Lou Gehrig's disease. We envision a world in which no one dies of ALS and play a unique role in the battle against this disease. Founded in 2013 by former New York City deputy mayor Dan Doctoroff – who lost both his father and uncle to ALS – our approach is breaking down barriers and silos that previously inhibited research results. We do this through our Target ALS Innovation Ecosystem, which facilitates unparalleled collaboration between researchers from academia and the pharma/biotech industry. The Target ALS Innovation Ecosystem has revolutionized the field in just seven years through collaborations that have resulted in the first potential treatments since ALS was identified in 1869.

    To date, the Target ALS Innovation Ecosystem, which launched in 2013 and set the groundwork for the new Target ALS Diagnosis Initiative, has yielded 175+ research projects, 12+ therapeutic targets and five clinical trials, to date.

    For further information, please contact:

    Head of Investor Relations

    Joshua Drumm, Ph.D.

    AC Immune

    Phone: +1 917 809 0814

    Email:



    US Media

    Katie Gallagher

    LaVoie Health Science

    Phone: +1 617 792 3937

    Email:



    Global Head of Communications

    Judith Moore

    AC Immune

    Phone: +41 79 826 63 82

    Email:

    European Investors & Media

    Chris Maggos

    LifeSci Advisors

    Phone: +41 79 367 6254

    Email:

    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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  12. Prof. June is a world authority on immune tolerance and adoptive immunotherapy

    Appointment reaffirms AC Immune's scientific leadership in neurodegeneration

    LAUSANNE, Switzerland, Nov. 20, 2020 (GLOBE NEWSWIRE) -- AC Immune SA (NASDAQ:ACIU), a Swiss-based, clinical-stage biopharmaceutical company with a broad pipeline focused on neurodegenerative diseases, today announced that Prof. Carl H. June, a world authority on mechanisms related to immune tolerance and adoptive immunotherapy in the fields of chronic inflammation and cancer, was elected to the Company's Board of Directors, at an extraordinary shareholders' meeting today.

    Prof. June is a true pioneer in the field of immunotherapy most well-known for his research into T cell therapies…

    Prof. June is a world authority on immune tolerance and adoptive immunotherapy

    Appointment reaffirms AC Immune's scientific leadership in neurodegeneration

    LAUSANNE, Switzerland, Nov. 20, 2020 (GLOBE NEWSWIRE) -- AC Immune SA (NASDAQ:ACIU), a Swiss-based, clinical-stage biopharmaceutical company with a broad pipeline focused on neurodegenerative diseases, today announced that Prof. Carl H. June, a world authority on mechanisms related to immune tolerance and adoptive immunotherapy in the fields of chronic inflammation and cancer, was elected to the Company's Board of Directors, at an extraordinary shareholders' meeting today.

    Prof. June is a true pioneer in the field of immunotherapy most well-known for his research into T cell therapies for the treatment of cancer, who, in 2020, was elected to the American Philosophical Society. His expertise can further accelerate AC Immune's progress in advancing its pipeline of immunotherapies and therapies targeting neuroinflammation.

    Prof. Andrea Pfeifer, CEO of AC Immune SA, commented: "We welcome Prof. June's timely appointment, as neurodegeneration is increasingly linked to inflammatory mechanisms, a key scientific focus for AC Immune's discovery efforts. His appointment is a further affirmation of our scientific leadership in the neurodegenerative disease field. Prof. June's significant expertise and standing in the scientific community will be an invaluable asset as we work to develop innovative immunotherapies and target neuroinflammation using our proprietary technology platforms."

    Prof. June commented: "I am proud to be invited to join the Board of Directors of AC Immune, an established pioneer at the forefront of discovering and developing treatments for neurodegenerative diseases. It is tremendously exciting to be involved at the cutting edge of research addressing an area with such a high unmet medical need, where immunotherapy and inflammation could play a critically important role. I look forward to working with the outstanding team at AC Immune and hope my own expertise will contribute to their continued success."

    Prof. June is Richard W. Vague Professor in Immunotherapy, Director of the Center for Cellular Immunotherapies and Director of the Parker Institute for Cancer Immunotherapy at the Perelman School of Medicine at the University of Pennsylvania. Due to his lifelong work on lymphocyte activation, Prof. June is considered a world authority on mechanisms related to immune tolerance and adoptive immunotherapy in the fields of chronic inflammation and cancer. He and his team pioneered the groundbreaking work in immunotherapy in which patients with refractory and relapsed chronic lymphocytic leukemia are treated with genetically engineered versions of their own T cells. This CAR-T therapy approach, which trains the immune system to attack and destroy cancer cells, has opened a new era of innovative treatments and personalized medicine for cancer patients.

    Prof. June is a graduate of the Naval Academy in Annapolis, USA, and Baylor College of Medicine in Houston, USA, where he received his medical degree. Prof. June also completed graduate training in immunology and malaria with Dr. Paul-Henri Lambert at the World Health Organization, Geneva, Switzerland, and post-doctoral training in transplantation biology with E. Donnell Thomas and John Hansen at the Fred Hutchinson Cancer Research Center in Seattle, USA. He has published more than 500 manuscripts and is the recipient of numerous honors and prizes.

    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, SupraAntigen™ and Morphomer™, 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 Genentech, a member of the Roche Group, Eli Lilly and Company and Janssen Pharmaceuticals.

    For further information, please contact:

    Head of Investor Relations

    Joshua Drumm, Ph.D.

    AC Immune

    Phone: +1 917 809 0814

    Email:

    US Media

    Katie Gallagher

    LaVoie HealthScience

    Phone: +1 617 792 3937

    Email:

      
    Global Head of Communications

    Judith Moore

    AC Immune

    Phone: +41 79 826 63 82

    Email:

    European Investors & Media

    Chris Maggos

    LifeSci Advisors

    Phone: +41 79 367 6254

    Email:

    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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  13. Prof. Streffer is an established authority on neuroscience and biomarker modalities

    Appointment reaffirms AC Immune's scientific leadership in neurodegeneration

    LAUSANNE, Switzerland, Nov. 18, 2020 (GLOBE NEWSWIRE) -- AC Immune SA (NASDAQ:ACIU), a Swiss-based, clinical-stage biopharmaceutical company with a broad pipeline focused on neurodegenerative diseases, today announced that Prof. Johannes R. Streffer, an authority on neurology and psychiatry, was hired as the Company's Chief Medical Officer, and he is expected to join the Company in January 2021.

    Prof. Streffer joins AC Immune from UCB Biopharma SPRL where he currently holds the position of Vice President, Head of Translational Medicine Neuroscience. His expertise will further…

    Prof. Streffer is an established authority on neuroscience and biomarker modalities

    Appointment reaffirms AC Immune's scientific leadership in neurodegeneration

    LAUSANNE, Switzerland, Nov. 18, 2020 (GLOBE NEWSWIRE) -- AC Immune SA (NASDAQ:ACIU), a Swiss-based, clinical-stage biopharmaceutical company with a broad pipeline focused on neurodegenerative diseases, today announced that Prof. Johannes R. Streffer, an authority on neurology and psychiatry, was hired as the Company's Chief Medical Officer, and he is expected to join the Company in January 2021.

    Prof. Streffer joins AC Immune from UCB Biopharma SPRL where he currently holds the position of Vice President, Head of Translational Medicine Neuroscience. His expertise will further accelerate AC Immune's progress in advancing its pipeline of therapies targeting neurodegenerative diseases.

    Prof. Andrea Pfeifer, CEO of AC Immune SA, commented: "We welcome Prof. Streffer's timely appointment, as his understanding of biomarkers and experience of clinical study design in Alzheimer's disease (AD), and particularly preclinical AD, will positively impact AC Immune's discovery efforts. His appointment is a further affirmation of our scientific leadership in the neurodegenerative disease field. Prof. Streffer's significant expertise and standing in the scientific and medical community will be an invaluable asset as we work to develop innovative treatments for neurodegenerative diseases using our proprietary technology platforms."

    Prof. Streffer commented: "I am humbled and proud to be invited to join AC Immune, an established pioneer at the forefront of discovering and developing treatments for neurodegenerative diseases. It is tremendously exciting to be involved at the cutting edge of research addressing an area with such a high unmet medical need and where my work on clinical studies and understanding early biomarkers in Alzheimer's could play a critically important role. The existing and developing pipeline of AC Immune is very impressive. I look forward to working with the outstanding team at AC Immune and hope my own expertise will contribute to their continued success."

    At UCB Prof. Streffer led the development of a translational space in neuroscience, integrating clinical and biomarker sciences. Prior to this he was a member of the Alzheimer Disease Area Leadership Team at Janssen, Pharmaceutical Companies of Johnson & Johnson. Here he gained experience in early experimental AD trials, including biomolecular modalities such as positron emission tomography (PET), volumetric and functional MRI, genetics, cognition and cerebrospinal fluid markers. As a member of the Experimental Medicine group and as leader of the Janssen BACE inhibitor (BACEi) program targeting Alzheimer's Disease he initiated a number of methodological and biomarker studies focusing on early diagnosis and translation. Prof. Streffer was also the industrial lead for European Medical Information Framework (EMIF)-AD. In the Innovative Medicines Initiative (IMI)-EMIF program researchers from 14 countries combined in a EUR 56 million project to integrate a wide variety of AD data cohorts to foster understanding of early biomarkers and change in the predementia AD spectrum.

    Prof. Streffer is a graduate of the University of Tübingen, Germany, where he received his medical degree. He also completed graduate studies on neuro-oncology and is Board certified in psychiatry and neurology. He has published more than 70 manuscripts and is a visiting Professor in the Department of Biomedical Sciences at the University of Antwerp.

    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 Genentech, a member of the Roche Group, Eli Lilly and Company and Janssen Pharmaceuticals.

    For further information, please contact:

    Head of Investor Relations

    Joshua Drumm, Ph.D.

    AC Immune

    Phone: +1 917 809 0814

    Email:

    US Media

    Katie Gallagher

    LaVoie HealthScience

    Phone: +1 617 792 3937

    Email:

      
    Global Head of Communications

    Judith Moore

    AC Immune

    Phone: +41 79 826 63 82

    Email:

    European Investors & Media

    Chris Maggos

    LifeSci Advisors

    Phone: +41 79 367 6254

    Email:

    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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    • Phase 1 trial completed in Lilly Morphomer™ Tau partnership program with plans to evaluate candidates in Alzheimer's disease and NeuroOrphan indications
    • First-in-class TDP-43 therapeutic and diagnostic programs advance as the target's role in a newly defined form of age-related dementia, limbic-predominant age-related TDP-43 encephalopathy (LATE), gains prominence, with a highly competitive grant awarded
    • All clinical and preclinical programs remain on track to meet all milestones expected in 2020
    • CHF 246.6 million in cash ensures operations are fully financed through Q1 2024             

    LAUSANNE, Switzerland, Nov. 13, 2020 (GLOBE NEWSWIRE) -- AC Immune SA (NASDAQ:ACIU), a Swiss-based, clinical-stage biopharmaceutical company with a broad pipeline…

    • Phase 1 trial completed in Lilly Morphomer™ Tau partnership program with plans to evaluate candidates in Alzheimer's disease and NeuroOrphan indications
    • First-in-class TDP-43 therapeutic and diagnostic programs advance as the target's role in a newly defined form of age-related dementia, limbic-predominant age-related TDP-43 encephalopathy (LATE), gains prominence, with a highly competitive grant awarded
    • All clinical and preclinical programs remain on track to meet all milestones expected in 2020
    • CHF 246.6 million in cash ensures operations are fully financed through Q1 2024             

    LAUSANNE, Switzerland, Nov. 13, 2020 (GLOBE NEWSWIRE) -- AC Immune SA (NASDAQ:ACIU), a Swiss-based, clinical-stage biopharmaceutical company with a broad pipeline focused on neurodegenerative diseases, today announced financial results for Q3 2020 and provided a business update. The Company ended the third quarter with CHF 246.6 million in cash, which ensures operations are fully financed through Q1 2024 allowing the Company to advance our clinical and preclinical projects to key value inflection points while investing further in our diverse pipeline.

    Prof. Andrea Pfeifer, CEO of AC Immune SA, commented: "AC Immune continued to advance its world-leading pipeline in Q3 2020, underpinned by our proprietary discovery platforms SupraAntigenTM and MorphomerTM and solid financial position.  Our proven business model of early development and partnering of validated therapeutic and diagnostic candidates has made us a global leader in precision medicine for neurodegenerative diseases. All clinical and preclinical milestones  expected this year remain on track with key data across our  Alzheimer's disease (AD) vaccines,  alpha-synuclein and NLRP3-ASC inflammasome programs this year – ­with the latter becoming a focus for neurodegenerative diseases and non-CNS applications. Together these milestones highlight progress in our late stage clinical programs and focus in NeuroOrphan indications with multiple near and mid-term catalysts."

    The strength of the Company's diversified approach continues to be demonstrated with the announcement today that the Phase 1 study of the small molecule Morphomer™ Tau aggregation inhibitor, ACI-3024 in healthy young, elderly and Japanese volunteers, has been completed.  In the study, which was conducted in partnership with Eli Lilly and Company, single and multiple dosing with the MorphomerTM Tau ACI-3024 resulted in a dose-dependent exposure and brain penetration by achieving the desired levels of ACI-3024 in the cerebrospinal fluid. The program will be expanded to NeuroOrphan indications and ACI-3024 will be further evaluated for efficacy in models of rare Tauopathies. Continued candidate characterization across the research program has also identified new and highly differentiated candidates with excellent cerebrospinal fluid exposure and selectivity for pathological aggregated Tau. These will be broadly developed in Tau-dependent neurodegenerative diseases.

    Prof. Pfeifer commented: "The pharmacokinetic observations from the Phase 1 trial in our Lilly Morphomer™ Tau partnership program show the first evidence of a Morphomer™ Tau entity meeting the target CNS concentration in humans. Compared to other Tau-targeting molecules in development, the key potential differentiating factor is that our Morphomer™ Tau molecules have been shown to act intracellularly to address Tau pathology, potentially saving affected neurons that otherwise might die. Our Morphomer™ Tau program is the most advanced orally available small molecule therapeutic candidate of its kind in development."

    Q3 2020 Research & Development Updates and Highlights:

    • The next phase of the strategic partnership between AC Immune and WuXi was  unveiled with plans to accelerate advancement of AC Immune's TDP-43 antibody into clinical development. A particular focus is developing the clinical antibody candidate to ensure it has high-affinity for TDP-43 and is capable of preventing the intercellular spread of toxic species. With no disease modifying therapies currently available that target TDP-43 there is significant unmet need and market potential 
    • A highly competitive European Union grant was awarded to support the partnership between AC Immune and the EU Joint Programme – Neurodegenerative Disease Research (JPND) ImageTDP-43 consortium to accelerate development of the Company's first-in-class TDP-43 positron emission tomography (PET) tracer. Advancement of the tracer may enable the development of precision medicine approaches for the large and growing proportion of patients with TDP-43-related pathologies, such as patients with LATE and AD
    • Top line results from a Phase 2 trial of the anti-Tau antibody in early (prodromal to mild) AD showed that semorinemab did not meet the co-primary efficacy endpoint or two secondary endpoints in the Tauriel study; the primary safety endpoint was met. Additional data presented at the CTAD 2020 Alzheimer Congress by our partner, Genentech, a member of the Roche group, confirm that semorinemab did not slow clinical progression or Tau accumulation relative to placebo with any of the three different  doses tested. Dose-dependent increases were seen in serum pharmacokinetics and there was clear and consistent evidence of plasma target engagement. Preliminary analysis continues to suggest that semorinemab has an acceptable and well-tolerated safety profile. A second Phase 2 (Lauriet) study of semorinemab in patients with moderate AD remains ongoing
    • Initiation of investigational new drug (IND)-enabling studies for AC Immune's first-in-class therapeutic antibody targeting TDP-43. The anti-TDP-43 antibody is the first therapeutic candidate shown to mitigate TDP-43 neuropathology in vivo and the Company plans to develop the antibody for the treatment of NeuroOrphan indications.  Effectively slowing or stopping the spread of TDP-43 pathology throughout the brain could provide the first antibody-based TDP-43 targeted therapeutic approach for treating conditions such as LATE, amyotrophic lateral sclerosis (ALS) and frontotemporal lobar degeneration with TDP-43 pathology, representing 50 per cent of all FTLD cases.

    Update on Covid-19

    AC Immune remains in continuous contact with its partners and other important stakeholders, including the Swiss government, trial investigators and contractors, and at this stage the Company is not modifying guidance with respect to the multiple clinical and preclinical data readouts anticipated this year. AC Immune will continue to keep the market apprised of any new developments or information that may impact clinical timelines.

    Analysis of Financial Statements for the Three and Nine Months Ended September 30, 2020

    • Revenues: Revenues for the three and nine months ended September 30, 2020 totaled CHF 1.1 million and CHF 14.5 million, respectively. This represents a decrease of CHF 32.1 million and CHF 95.1 million over the comparable periods in 2019. The decrease for the three months ended September 30, 2020 relates to the prior recognition of CHF 30 million for the first installment of the first milestone achieved with Lilly and CHF 2.2 million for the initiation of a Phase 2 trial of Tau PET tracer with Life Molecular Imaging that did not repeat in the current quarter. The decrease for the nine months ended September 30, 2020 predominantly relates to CHF 104.5 million recognized in the prior period associated with our license agreement with Lilly offset by a recognition of a CHF 10 million milestone payment and CHF 4.1 million for research and development activities performed in the current period
    • R&D Expenditures: For the three and nine months ended September 30, 2020, R&D expenses increased by CHF 4.0 million (+35.2%) and CHF 7.8 million (+21.7%) to CHF 15.5 million and CHF 43.5 million, respectively. For R&D expenses directly allocated to R&D programs, the Company increased investments in its non-AD programs predominantly led by increases in ACI-24 in Down syndrome related to scaling up activities for a Phase 2 clinical study, investments to advance our alpha-synuclein projects and the development of our anti-TDP-43 antibody with the initiation of IND-enabling studies. For AD, the Company's expenditures for ACI-24 in AD decreased due to completing the manufacturing process development. The Company also spent less for ACI-35 in the current period related to toxicology and manufacturing costs for clinical trial material in the prior period that did not repeat in the current period

      Additionally, personnel costs in R&D increased by CHF 0.6 million and CHF 2.0 million for the three and nine months ended September 30, 2020, respectively driven by an increase of 11 FTEs during the year. The remaining increases of CHF 0.9 million and CHF 1.8 million relate to an increase in regulatory and quality assurance, intellectual property and other unallocated research and development costs
    • G&A Expenses: For the three and nine months ended September 30, 2020, G&A expenses increased CHF 0.9 million (+23.7%) and CHF 2.7 million (+25.1%) to CHF 4.9 million and CHF 13.6 million, respectively. Increases were driven by an addition of 4 FTEs as well as an increase in professional services and depreciation expenses.
    • IFRS (Loss)/Income for the period: The Company incurred a net loss after taxes of CHF 19.0 million and CHF 42.4 million for the three and nine months ended September 30, 2020, respectively, compared with net income of CHF 18.2 million and CHF 64.9 million for the comparable periods in 2019, predominantly related to the variance in revenues and operating expenses discussed above
    • Cash Position: The Company had a total cash balance of CHF 246.6 million, comprised of CHF 176.6 million in cash and cash equivalents and CHF 70 million in short-term financial assets. This compares to a total cash balance of CHF 288.6 million as of December 31, 2019. This decrease of CHF 42 million is principally due to the factors noted above in the income statement which resulted in a CHF 42.4 million net loss for the period and changes in our working capital. Further details are available in our Statements of Cash Flows on the accompanying Form 6-K

    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 Genentech, a member of the Roche group, Eli Lilly and Company, and Janssen Pharmaceuticals.

    For further information, please contact:

    Head of Investor Relations

    Joshua Drumm, Ph.D.

    AC Immune

    Phone: +1 917 809 0814

    Email:



     
    US Media

    Katie Gallagher

    LaVoieHealthScience

    Phone: +1 617 792 3937

    Email:



     
    Global Head of Communications

    Judith Moore

    AC Immune

    Phone: +41 79 826 63 82

    Email:



    European Investors & Media

    Chris Maggos

    LifeSci Advisors

    Phone: +41 79 367 6254

    Email:

    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.

     
    Balance Sheets
    (in CHF thousands)
     As of September 30,

    2020
     As of December 31,

    2019
    ASSETS   
    Non-current assets    
    Property, plant and equipment3,785  3,917 
    Right-of-use assets1,932  2,255 
    Long-term financial assets304  304 
    Total non-current assets           6,021  6,476 
         
    Current assets    
    Prepaid expenses2,764  2,788 
    Accrued income944  1,095 
    Other current receivables314  304 
    Short-term financial assets70,000  95,000 
    Cash and cash equivalents176,567  193,587 
    Total current assets      250,589  292,774 
    Total assets256,610  299,250 
         
    SHAREHOLDERS' EQUITY AND LIABILITIES    
         
    Shareholders' equity    
    Share capital1,539  1,437 
    Share premium346,842  346,526 
    Treasury shares(100)  
    Accumulated losses(115,038) (75,521)
    Total shareholders' equity233,243  272,442 
         
    Non-current liabilities    
    Long-term lease liabilities1,491  1,813 
    Net employee defined benefit liabilities8,029  7,485 
    Total non-current liabilities      9,520  9,298 
         
    Current liabilities    
    Trade and other payables1,020  142 
    Accrued expenses10,996  11,797 
    Short-term deferred income1,080  4,477 
    Short-term financing obligation310  652 
    Short-term lease liabilities441  442 
    Total current liabilities13,847  17,510 
    Total liabilities 23,367  26,808 
    Total shareholders' equity and liabilities          256,610  299,250 



     
    Statements of Income/(Loss)
    (in CHF thousands except per share data)
     
     For the Three Months

    Ended September 30,
      

    For the Nine Months

    Ended September 30,


     2020  2019  2020

     2019 
    Revenue         
    Contract revenue1,123  33,208 14,487  109,596 
    Total revenue   1,123  33,208 14,487  109,596 
              
    Operating expenses         
    Research & development expenses(15,518) (11,478)(43,536) (35,770)
    General & administrative expenses(4,892) (3,956)(13,553) (10,835)
    Other operating income/(expenses)482  203 807  368 
    Total operating expenses         (19,928) (15,231)(56,282) (46,237)
    Operating income/(loss)           (18,805) 17,977 (41,795) 63,359 
              
    Finance expense, net(146) 249 (552) (1,564)
    Change in fair value of conversion feature     4,542 
    Interest income  73 78  237 
    Interest expense(43) (86)(152) (1,686)
    Finance result, net       (189) 236 (626) 1,529 
              
    Income/(loss) before tax           (18,994) 18,213 (42,421) 64,888 
    Income tax expense      
    Income/(loss) for the period     (18,994) 18,213 (42,421) 64,888 
              
    Earnings/(loss) per share (EPS):         
    Basic income/(loss) for the period attributable to equity holders(0.26) 0.25 (0.59) 0.92 
    Diluted income/(loss) for the period attributable to equity holders(0.26) 0.25 (0.59) 0.92 



    Statements of Comprehensive Income/(Loss)For the Three Months

    Ended September 30,


     For the Nine Months

    Ended September 30,


    (in CHF thousands) 2020 2019 2020  2019
             
    Income/(loss) for the period(18,994)18,213 (42,421) 64,888
    Other comprehensive income/(loss) not to be reclassified to income or loss in subsequent periods (net of tax):        
    Re-measurement losses on defined benefit plans    
    Total comprehensive income/(loss), net of tax(18,994)18,213 (42,421) 64,888

      

     
    Reconciliation of Income/(Loss) to Adjusted Income/(Loss) and
    Earnings/(Loss) Per Share to Adjusted Earnings/(Loss) Per Share
     
     For the Three Months

    Ended September 30


     For the Nine Months

    Ended September 30,
     2020  2019  2020  2019 
     (in CHF thousands except for share and per share data)

    Income/(Loss)(18,994) 18,213  (42,421) 64,888 
    Adjustments:           
    Non-cash share-based payments (a)1,233  882  3,079  2,027 
    Foreign currency losses (b)187  (272) 686  286 
    Effective interest expense (c)      1,355 
    Change in fair value of conversion feature (d)      (4,542)
    Adjusted Income/(Loss)(17,574) 18,823  (38,656) 64,014 
                
    Earnings/(Loss) per share – basic(0.26) 0.25  (0.59) 0.92 
    Earnings/(Loss) per share – diluted(0.26) 0.25  (0.59) 0.92 
    Adjustment to earnings/(loss) per share – basic0.02  0.01  0.05  (0.01)
    Adjustment to earnings/(loss) per share – diluted0.02  0.01  0.05  (0.01)
    Adjusted earnings/(loss) per share – basic(0.24) 0.26  (0.54) 0.91 
    Adjusted earnings/(loss) per share – diluted(0.24) 0.26  (0.54) 0.91 
    Weighted-average number of shares outstanding Adjusted earnings/(loss)–basic71,925,009  71,822,884  71,888,273  70,184,257 
    Weighted-average number of shares outstanding Adjusted earnings/(loss)–diluted71,925,009  72,281,264  71,888,273  70,700,690 



    (a)Reflects non-cash expenses associated with share-based compensation for equity awards issued to Directors, Management and employees of the Company. This expense reflects the awards' fair value recognized for the portion of the equity award which is vesting over the period.
    (b)Reflects foreign currency remeasurement gains and losses for the period, predominantly impacted by the change in the exchange rate between the US Dollar and the Swiss Franc.
    (c)Effective interest expense for the period relates to the accretion of the Company's convertible loan in accordance with the effective interest method.
    (d)Change in fair value of conversion feature that is bifurcated from the convertible loan host debt with Lilly.

    Adjustments for the three and nine months ended September 30, 2020, were CHF 1.4 million and CHF 3.8 million decreases in net losses compared with an increase to net income and a decrease to net income of CHF 0.6 million and CHF 0.9 million for the comparable periods in 2019, respectively. The Company recorded CHF 1.2 million and CHF 3.1 million for the three and nine months, respectively, for share-based compensation expenses. There were foreign currency remeasurement losses of less than CHF 0.2 million and CHF 0.7 million, respectively, predominantly related to the movement in our forward contract settled in Q2 2020. For the three months ended September 30, 2019, the Company recorded CHF 0.9 million for share-based compensation expenses. For the nine months ended September 30, 2019, the Company recorded CHF 2.0 million for share-based compensation expense. Additionally, the Company recorded CHF 1.4 million for amortization of effective interest and a CHF 4.5 million gain for the change in fair value of the liability related to the conversion feature for the nine months ended September 30, 2019. These were not repeated in the current period.

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  14. LAUSANNE, Switzerland, Nov. 12, 2020 (GLOBE NEWSWIRE) -- AC Immune SA (NASDAQ:ACIU), a Swiss-based, clinical-stage biopharmaceutical company with a broad pipeline focused on neurodegenerative diseases, today announced that it will participate in a fireside chat during the upcoming Jefferies Virtual London Healthcare Conference.

    The presentation will feature an overview of the Company's business strategy and 2021 product development objectives in alignment with AC Immune's vision for precision medicine for neurodegenerative diseases. The discussion will also feature the Company's early- and late-stage development pipeline with a focus on its novel antibody and diagnostic candidates addressing an emerging target in neurodegenerative diseases…

    LAUSANNE, Switzerland, Nov. 12, 2020 (GLOBE NEWSWIRE) -- AC Immune SA (NASDAQ:ACIU), a Swiss-based, clinical-stage biopharmaceutical company with a broad pipeline focused on neurodegenerative diseases, today announced that it will participate in a fireside chat during the upcoming Jefferies Virtual London Healthcare Conference.

    The presentation will feature an overview of the Company's business strategy and 2021 product development objectives in alignment with AC Immune's vision for precision medicine for neurodegenerative diseases. The discussion will also feature the Company's early- and late-stage development pipeline with a focus on its novel antibody and diagnostic candidates addressing an emerging target in neurodegenerative diseases, TAR DNA-binding protein 43 (TDP-43).

    AC Immune's CEO, Prof. Andrea Pfeifer, Ph.D., will discuss AC Immune's focused strategy for accelerating development of its first-/best-in-class candidates in Alzheimer's disease, as well as key neurodegenerative and non-CNS indications, in order to maximize the value of its pipeline in 2021 and beyond. The presentation will be followed by a question and answer session and will also feature progress made in the Company's TDP-43-targeted therapeutic and diagnostic programs, which are among the most advanced in the world. TDP-43 is an emerging neuropathology that plays a key role in AD, as well as a number of NeuroOrphan indications such as amyotrophic lateral sclerosis (ALS) and frontotemporal lobar degeneration with TDP-43 pathology (FLTD-TDP). A more recently described dementia, limbic-predominant age-related TDP-43 encephalopathy (LATE), is a highly prevalent Alzheimer's-like dementia. TDP-43 neuropathological changes underlying LATE, are present in 20–50% of individuals over 80 years old1 and AC Immune's therapeutic antibody and diagnostic imaging agent could be the first in the world to enable a precision medicine approach to this important disease driver.

    Jefferies Virtual London Healthcare Conference

    Date: November 18, 2020 | 6:45–7:15 am ET / 11:45am–12:15 pm GMT

    Format: Virtual Presentation followed by Q&A

    Presenter: Prof. Andrea Pfeifer, CEO, AC Immune SA

    A webcast of the presentation will be available on the Events Page of AC Immune's website.

    1 2019, Nelson et al. Consensus working group report

    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 Genentech, a member of the Roche Group, Eli Lilly and Company and Janssen Pharmaceuticals.

    For further information, please contact:

    Head of Investor Relations

    Joshua Drumm, Ph.D.

    AC Immune

    Phone: +1 917 809 0814

    Email:

    US Media

    Katie Gallagher

    LaVoie Health Science

    Phone: +1 617 792 3937

    Email:

      
    Global Head of Communications

    Judith Moore

    AC Immune

    Phone: +41 79 826 63 82

    Email:

    European Investors & Media

    Chris Maggos

    LifeSci Advisors

    Phone: +41 79 367 6254

    Email:

    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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  15. LAUSANNE, Switzerland, Nov. 09, 2020 (GLOBE NEWSWIRE) -- AC Immune SA (NASDAQ:ACIU), a Swiss-based, clinical-stage biopharmaceutical company with a broad pipeline focused on neurodegenerative diseases and WuXi Biologics ("WuXi Bio") (2269.HK), a global company with leading open-access biologics technology platforms, today unveiled plans to accelerate advancement of AC Immune's TDP-43 antibody into clinical development for NeuroOrphan indications.

    This next phase of the strategic partnership between the companies builds on the industry leading know-how of AC Immune's proprietary drug discovery and development platforms and WuXi Biologics' expertise in manufacturing innovative biologics. A particular focus is developing AC Immune's clinical…

    LAUSANNE, Switzerland, Nov. 09, 2020 (GLOBE NEWSWIRE) -- AC Immune SA (NASDAQ:ACIU), a Swiss-based, clinical-stage biopharmaceutical company with a broad pipeline focused on neurodegenerative diseases and WuXi Biologics ("WuXi Bio") (2269.HK), a global company with leading open-access biologics technology platforms, today unveiled plans to accelerate advancement of AC Immune's TDP-43 antibody into clinical development for NeuroOrphan indications.

    This next phase of the strategic partnership between the companies builds on the industry leading know-how of AC Immune's proprietary drug discovery and development platforms and WuXi Biologics' expertise in manufacturing innovative biologics. A particular focus is developing AC Immune's clinical antibody candidate to ensure it has high-affinity for TDP-43 and is capable of preventing the intercellular spread of toxic species. With no disease modifying therapies currently available that target TDP-43 there is significant unmet need and market potential.

    Prof. Andrea Pfeifer, CEO of AC Immune SA, commented: "This strategic partnership highlights the benefits of a synergy between the WuXi Biologics' integrated platforms and AC Immune's leading drug discovery and development platforms for neurodegenerative diseases, to rapidly move candidates from discovery through clinical development and accelerate the time-to-market. Particular expertise is required in the field of monoclonal antibody development, working with a global leader like WuXi Biologics allows us to work together up to commercialization. This also reflects AC Immune's growth, where previously monoclonal antibodies were licensed out from discovery phase.

    "The agreement with WuXi Biologics is a further demonstration of how we partner productively with major industry players to enhance the drug development process and bring our groundbreaking treatments to patients."

    Dr. Chris Chen, CEO of WuXi Biologics, said: "We are pleased to enable AC Immune to turn promising candidates into tangible treatments to fulfill the unmet medical needs in the field of CNS disorder. This strategic partnership reflects the extensive trust and recognition of WuXi Biologics from AC Immune. Through our leading technology platforms, we look forward to empowering AC Immune to accelerate novel biologics development and benefiting patients worldwide." 

    The expansion of the partnership between the companies with the new agreement, follows data presented at this year's AAT-AD/PD™ conference on AC Immune's SupraAntigen™-derived anti-TDP-43 therapeutic antibody candidate, which supported advancement into IND-enabling studies. Through the new agreement, AC Immune gains access to WuXi Biologics' proprietary platforms including cell line development platform, for the clinical manufacturing of AC Immune's TDP-43 monoclonal antibodies. Under the agreement, AC Immune retains all intellectual property rights to molecules.

    About TDP-43

    The aggregation of pathological forms of TDP-43 is a hallmark of numerous neurodegenerative diseases. Effectively slowing or stopping the spread of TDP-43 pathology throughout the brain could provide the first antibody-based TDP-43 targeted therapeutic approach for treating conditions such as age-related dementia, limbic-predominant age-related TDP-43 encephalopathy (LATE), amyotrophic lateral sclerosis (ALS) and frontotemporal lobar degeneration with TDP-43 pathology (FTLD-TDP), with almost half of all FTLD cases exhibiting TDP-43 pathology.

    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, SupraAntigen™ and Morphomer™, 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 Genentech, a member of the Roche Group, Eli Lilly and Company and Janssen Pharmaceuticals.

    About WuXi Biologics

    WuXi Biologics (stock code: 2269.HK), a Hong Kong-listed company, is a leading global open-access biologics technology platform offering end-to-end solutions to empower organizations to discover, develop, and manufacture biologics from concept to commercial manufacturing. The company's history and achievements demonstrate its commitment to providing a truly ONE-stop service offering and strong value proposition to its global clients. As of June 30, 2020, there were a total of 286 integrated projects, including 141 projects in pre-clinical development stage, 125 projects in early-phase (phase I and II) clinical development, 19 projects in late-phase (phase III) development and one project in commercial manufacturing. With total estimated capacity for biopharmaceutical production planned in China, Ireland, the U.S., Germany, and Singapore exceeding 280,000 liters after 2023, WuXi Biologics will provide its biomanufacturing partners with a robust and premier-quality global supply chain network. For more information on WuXi Biologics, please visit: www.wuxibiologics.com.

    For further information, please contact:

    Head of Investor Relations

    Joshua Drumm, Ph.D.

    AC Immune

    Phone: +1 917 809 0814

    Email:



    US Media

    Katie Gallagher

    LaVoieHealthScience

    Phone: +1 617 792 3937

    Email:



    Global Head of Communications

    Judith Moore

    AC Immune

    Phone: +41 79 826 63 82

    Email:



    European Investors & Media

    Chris Maggos

    LifeSci Advisors

    Phone: +41 79 367 6254

    Email:

    WuXi Biologics

    Media

    WuXi Biologics

    Investor

    I

    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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  16. Oxurion NV appoints Tom Graney, CFA as Chief Financial Officer

    Boston-based former Vertex and Generation Bio CFO Brings Significant Operational, US Capital Markets and Investor Relations Expertise

    Leuven, Belgium and Boston, MA, USA; 13th October 2020 – 5.45 p.m. CET Oxurion NV (Euronext Brussels: OXUR), a biopharmaceutical company developing next generation standard-of-care therapies for Diabetic Macular Edema (DME), is pleased to announce the appointment of Tom Graney as its Chief Financial Officer (CFO). Mr. Graney will begin his role on 14th October and will be based in Boston, MA, US. He will succeed Dominique Vanfleteren who, according to plan, is leaving Oxurion to pursue other interests. 

    Mr. Graney will be responsible for the…

    Oxurion NV appoints Tom Graney, CFA as Chief Financial Officer

    Boston-based former Vertex and Generation Bio CFO Brings Significant Operational, US Capital Markets and Investor Relations Expertise

    Leuven, Belgium and Boston, MA, USA; 13th October 2020 – 5.45 p.m. CET Oxurion NV (Euronext Brussels: OXUR), a biopharmaceutical company developing next generation standard-of-care therapies for Diabetic Macular Edema (DME), is pleased to announce the appointment of Tom Graney as its Chief Financial Officer (CFO). Mr. Graney will begin his role on 14th October and will be based in Boston, MA, US. He will succeed Dominique Vanfleteren who, according to plan, is leaving Oxurion to pursue other interests. 

    Mr. Graney will be responsible for the extension and execution of the financial strategy to support Oxurion's ambitious global growth plans, including the important US market.

    Tom has over 25 years' experience in senior finance, strategy and operational roles including capital raising, accounting, and audit. He most recently served as CFO at Generation Bio (NASDAQ:GBIO), a non-viral gene therapy company based in Cambridge, MA, where he led all of the company's financial operations.

    Prior to joining Generation Bio, Tom was Senior Vice President (SVP) and CFO at Vertex Pharmaceuticals (NASDAQ:VRTX), one of the world's most highly valued biotech companies, with a multi-billion-dollar turnover. At Vertex Tom was responsible for financial strategy and operations including finance, accounting, and internal audit functions.

    Prior to Vertex, he was the CFO and SVP of Finance and Corporate Strategy at Ironwood Pharmaceuticals (NASDAQ:IRWD), a GI-focused healthcare company. Before joining Ironwood, Tom spent 20 years with Johnson & Johnson, serving in various roles in the US and abroad, including being Worldwide VP of Finance and CFO of Ethicon, a major medical device company, and VP and CFO of Janssen Pharmaceuticals NA, a major pharmaceutical company in North America.

    Tom is currently on the board of AC Immune SA (NASDAQ:ACIU), a clinical stage Swiss biopharmaceutical company focused on neurodegenerative diseases.

    Tom holds a Bachelor of Science degree in accounting from the University of Delaware and a Master of Business Administration in marketing, finance, and international business from the Leonard N. Stern School of Business at New York University. Tom is also a CFA charterholder.

    "We are delighted to welcome Tom to Oxurion. I am convinced that Tom's significant financial management and US capital markets experience will enable him to play a crucial role in the successful execution of our plans to develop the industry leading franchise for the treatment of DME, currently a $4.5 billion annual market opportunity. With both Tom and Grace, our recently appointed CMO, being based in the US, we are starting to build the transatlantic organization we need to deliver on our global ambition.

    On behalf of the Board I would like to take this opportunity to thank Dominique for his contribution to Oxurion over the last 5 years and for agreeing to support us to ensure a smooth transition. I would like to wish him every success in his future career." said Dr Patrik De Haes, CEO of Oxurion.

    Tom Graney, the newly appointed CFO of Oxurion, added: "I am excited to have the opportunity to work with Patrik and the team at Oxurion. With THR-149 and THR-687, I believe Oxurion has two highly differentiated new drug candidates that have the potential to address the needs of nearly all patients with DME, a serious sight threatening condition. I am looking forward to using my experience to ensure Oxurion has continued access to the financial resources needed to achieve its ambitious corporate goals."

    _

    Oxurion Virtual R&D Investor Day to take place on Thursday 15th October 2020 at 5.30 p.m. CET/ 11.30 a.m. ET

    Please consult Oxurion's website for registration and call details, or follow this link:

    https://www.investis-live.com/oxurion/5f7c2e6ed33b270c005a4f88/ffdl

    END

    For further information please contact:

    Oxurion NV

    Dr Patrik De Haes

    CEO

    Tel: +32 16 75 13 10



     
    Citigate Dewe Rogerson

    David Dible/ Sylvie Berrebi/ Frazer Hall

    Tel: +44 20 7638 9571

    About Oxurion

    Oxurion (Euronext Brussels: OXUR) is a biopharmaceutical company developing next generation standard of care ophthalmic therapies, which are designed to better preserve vision in patients with diabetic macular edema (DME), the leading cause of vision loss in diabetic patients worldwide.

    Oxurion is building a leading global franchise in the treatment of DME, based on the successful development of its two novel therapeutics:

     ·THR-149, a plasma kallikrein inhibitor being developed as a potential new standard of care for DME patients who respond sub-optimally to anti-VEGF therapy.

    THR-149 has shown positive topline Phase 1 results for the treatment of DME. The Company is currently conducting a Phase 2 clinical trial evaluating THR-149 with DME-patients who previously responded sub-optimally to anti-VEGF therapy.

    THR-149 was developed in conjunction with Bicycle Therapeutics PLC (NASDAQ:BCYC).

     ·THR-687, is a pan-RGD integrin inhibitor, that is initially being developed as a potential new standard of care for all DME patients.

    Positive topline results in a Phase 1 clinical study assessing THR-687 as a treatment for DME were announced in January 2020. THR-687 is expected to enter a Phase 2 clinical trial by mid-2021.

    THR-687 is an optimized compound derived from a broader library of integrin inhibitors in-licensed from Galapagos NV ((Euronext &, NASDAQ:GLPG).

    Oxurion is headquartered in Leuven, Belgium, and is listed on the Euronext Brussels exchange under the symbol OXUR.

    More information is available at www.oxurion.com.

    Important information about forward-looking statements

    Certain statements in this press release may be considered "forward-looking". Such forward-looking statements are based on current expectations, and, accordingly, entail and are influenced by various risks and uncertainties. The Company therefore cannot provide any assurance that such forward-looking statements will materialize and does not assume an obligation to update or revise any forward-looking statement, whether as a result of new information, future events, or any other reason. Additional information concerning risks and uncertainties affecting the business and other factors that could cause actual results to differ materially from any forward-looking statement is contained in the Company's Annual Report. This press release does not constitute an offer or invitation for the sale or purchase of securities or assets of Oxurion in any jurisdiction.  No securities of Oxurion may be offered or sold within the United States without registration under the U.S. Securities Act of 1933, as amended, or in compliance with an exemption therefrom, and in accordance with any applicable U.S. state securities laws.

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  17. Grant from the EU Joint Programme – Neurodegenerative Disease Research' (JPND) provides €1.45M in funding for the program

    AC Immune's proprietary Morphomer™ platform continues accelerating development of first- and best-in-class small molecule therapeutics and diagnostics for neurodegenerative diseases

    LAUSANNE, Switzerland, Oct. 09, 2020 (GLOBE NEWSWIRE) -- AC Immune SA (NASDAQ:ACIU), a Swiss-based, clinical-stage biopharmaceutical company with a broad pipeline focused on neurodegenerative diseases, today announced that a highly competitive European Union grant has been awarded to support the partnership between AC Immune and the JPND ImageTDP-43 consortium to accelerate development of the Company's first-in-class TDP-43 positron emission…

    Grant from the EU Joint Programme – Neurodegenerative Disease Research' (JPND) provides €1.45M in funding for the program

    AC Immune's proprietary Morphomer™ platform continues accelerating development of first- and best-in-class small molecule therapeutics and diagnostics for neurodegenerative diseases

    LAUSANNE, Switzerland, Oct. 09, 2020 (GLOBE NEWSWIRE) -- AC Immune SA (NASDAQ:ACIU), a Swiss-based, clinical-stage biopharmaceutical company with a broad pipeline focused on neurodegenerative diseases, today announced that a highly competitive European Union grant has been awarded to support the partnership between AC Immune and the JPND ImageTDP-43 consortium to accelerate development of the Company's first-in-class TDP-43 positron emission tomography (PET) tracer.

    The grant, which is awarded in response to the European Union JPND's call for novel imaging and brain stimulation methods and technologies related to neurodegenerative diseases, will be spearheaded through a world-class collaboration with the University of Zurich, Fondazione Santa Lucia-IRCCS, Skåne University Hospital, the International Centre for Genetic Engineering and Biotechnology, and the Erasmus University Medical Center through the JPND's ImageTDP-43 Consortium.

    Advancement of AC Immune's TDP-43 PET tracer could deliver the world's first imaging agent capable of accurately detecting and monitoring the progression of a wide range of TDP-43-related neurodegenerative diseases such as amyotrophic lateral sclerosis (ALS), frontotemporal lobar degeneration with TDP-43 pathology (FTLD-TDP) and limbic-predominant age-related TDP-43 encephalopathy (LATE). Such a TDP-43 imaging agent may also enable the development of precision medicine approaches for Alzheimer's disease (AD), where pathological aggregation of TDP-43 has emerged as an important co-pathology linked to disease severity.

    Prof. Andrea Pfeifer, CEO of AC Immune SA, commented: "We are very proud to receive this validation from the EU's JPND, which reinforces our position as the leader in developing novel therapies and diagnostics against neurodegenerative diseases. Our first-in-class TDP-43 PET tracer has exhibited great promise to date, as it has been shown to bind to brain-derived pathological TDP-43 aggregates with high affinity and direct target engagement on patient brain tissue. The rapid progress made in this program complements the ongoing development of our anti-TDP-43 antibody, which is on track to become the first such therapeutic to enter clinical development."

    "The combined progress of our TDP-43-targeted therapeutic and diagnostic programs is yet another example of how AC Immune is leveraging its proprietary drug discovery platforms to develop an industry-leading pipeline against a wide-range of targets. Through the continued advancement of this pipeline, AC Immune is taking a comprehensive approach towards the treatment of neurodegenerative diseases through precision medicine. This strategy is crucial, as it is becoming increasingly clear that neurodegenerative diseases are driven by a complex interplay of pathologies and will likely require combination therapies that are informed and enabled by novel diagnostics and therapeutics able to target specific proteinopathies."

    TDP-43 is an RNA/DNA-binding protein that functions primarily in the nucleus as a regulator of gene transcription and RNA metabolism. Pathological aggregation of TDP-43 is strongly associated with cognitive decline and episodic memory loss in neurodegenerative diseases. AC Immune's TDP-43 PET tracer candidates are derived from the Company's innovative Morphomer™ discovery platform, which accelerates the design, development and synthesis of conformation-specific small molecules to power successful diagnostic and therapeutic approaches. The Morphomer™ platform has produced multiple small molecules with clinical proof-of-concept that bind selectively to pathological forms of human proteins such as TDP-43, alpha-synuclein and Tau. The Company's orally available small molecule Morphomer™ TDP-43 therapeutic candidate is currently in pre-IND development. This grant offers an opportunity to better understand how AC Immune's proprietary Morphomer™ compounds interact with various forms of TDP-43 aggregates, such as the intranuclear aggregates present in frontotemporal lobar dementias (FTLDs).

    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, SupraAntigen™ and Morphomer™, 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 Genentech, a member of the Roche Group, Eli Lilly and Company and Janssen Pharmaceuticals.

    For further information, please contact:

    Head of Investor Relations

    Joshua Drumm, Ph.D.

    AC Immune

    Phone: +1 917 809 0814

    Email:

    US Media

    Katie Gallagher

    LaVoie Health Science

    Phone: +1 617 792 3937

    Email:

      
    Global Head of Communications

    Judith Moore

    AC Immune

    Phone: +41 79 826 63 82

    Email:

    European Investors & Media

    Chris Maggos

    LifeSci Advisors

    Phone: +41 79 367 6254

    Email:

      

    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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  18. Genentech disclosed that the anti-Tau antibody did not meet the co-primary efficacy endpoint or two secondary endpoints in the TAURIEL study; the primary safety endpoint was met

    Multiple other clinical stage programs progressing as planned

    Investigational new drug (IND) enabling studies ongoing for first-in-class therapeutic candidates targeting TDP-43 and alpha-synuclein

    Discovery on novel neuroinflammation target NLRP3-ASC inflammasome, including antibody and small molecule MorphomerTM inhibitors, advancing

    AC Immune remains in a strong financial position with operations fully financed through Q1 2024

    LAUSANNE, Switzerland,, Sept. 23, 2020 (GLOBE NEWSWIRE) -- AC Immune SA (NASDAQ:ACIU), a Swiss-based, clinical-stage biopharmaceutical…

    Genentech disclosed that the anti-Tau antibody did not meet the co-primary efficacy endpoint or two secondary endpoints in the TAURIEL study; the primary safety endpoint was met

    Multiple other clinical stage programs progressing as planned

    Investigational new drug (IND) enabling studies ongoing for first-in-class therapeutic candidates targeting TDP-43 and alpha-synuclein

    Discovery on novel neuroinflammation target NLRP3-ASC inflammasome, including antibody and small molecule MorphomerTM inhibitors, advancing

    AC Immune remains in a strong financial position with operations fully financed through Q1 2024

    LAUSANNE, Switzerland,, Sept. 23, 2020 (GLOBE NEWSWIRE) -- AC Immune SA (NASDAQ:ACIU), a Swiss-based, clinical-stage biopharmaceutical company with a broad pipeline focused on neurodegenerative diseases, today announced that Genentech, a member of the Roche Group, has informed the Company of top line results from a Phase 2 trial of the anti-Tau antibody, semorinemab, in early (prodromal to mild) Alzheimer's disease (AD) which show that semorinemab did not meet its primary efficacy endpoint of reducing decline on Clinical Dementia Rating-Sum of Boxes (CDR-SB) compared to placebo. Two secondary endpoints, Alzheimer's Disease Assessment Scale-Cognitive Subscale 13 (ADAS-Cog13) and Alzheimer's Disease Cooperative Study Group – Activities of Daily Living Inventory (ADCS-ADL) were also not met.

    Additional data analyses are ongoing and Genentech plans to present the results from TAURIEL at an upcoming medical congress. The second Phase 2 (LAURIET) study of semorinemab in patients with moderate AD remains ongoing.

    Prof. Andrea Pfeifer, CEO of AC Immune SA, commented: "Today's news is surprising and disappointing, given what we as a field know about Tau and its strong spatiotemporal correlation with both symptoms and pathology in AD. We believe the full data analysis of this first-of-its-kind study will yield information about this promising target that will advance our understanding and inform future efforts to successfully develop effective therapeutics for neurodegenerative diseases (NDD). We would like to thank the patients, caregivers and investigators who participated in this important, ground-breaking trial and look forward to the final results from our partner, Genentech."

    Prof. Pfeifer continued, "Our proprietary technology platforms and proven business model of discovery, early development and partnering high-risk therapeutic candidates for AD have successfully generated CHF 334 million in non-dilutive funding and enabled us to accelerate clinical development of our product candidates in collaboration with world-leading partners. This strategy enables us to focus our resources on advancing the next generation of first-in-class or best-in-class assets. With current funding through Q1 2024, this robust risk-and-financial-sharing strategy will continue unaffected as we work diligently to mature our proprietary candidates and generate substantial future value for the Company."

    "One of AC Immune's key strengths is our diversified approach and our broad pipeline of assets, fueled by our remarkably efficient SupraAntigen™ and Morphomer™ platforms and staff. This is evidenced by our novel therapeutic candidates targeting TDP-43 and alpha-synuclein, which have advanced rapidly from discovery into IND-enabling studies. Furthermore, we are particularly pleased with progress in our recently disclosed discovery program targeting the NLRP3-ASC inflammasome," Prof. Pfeifer added.

    Both TDP-43 and alpha-synuclein are major pathologies in NDD and are increasingly thought to be important co-pathologies in AD. AC Immune's programs directed towards these targets are the most advanced and comprehensive in the field. AC Immune's alpha-synuclein positron emission tomography (PET) tracer program for Parkinson's disease (PD) diagnostics was recently recognized by the Michael J. Fox Foundation (MJFF) award. Activation of the NLRP3-ASC inflammasome leads to chronic and uncontrolled inflammation, which is understood to drive a number of neurodegenerative and inflammatory diseases. AC Immune's approach has high potential for effective therapies, in NDD and non-NDD as mono- and/or combination therapy.

    Broad Pipeline and Upcoming Milestones in 2020

    AC Immune's additional anti-Tau clinical assets are outlined below as well as additional milestone tables from the broader pipeline.

    • ACI-35.030 (anti-Tau vaccine): ACI-35.030 is the first anti-phospho-Tau (pTau) vaccine to reach Phase 2 clinical development. The vaccine generates a polyclonal antibody response that targets epitopes that differ from the epitope targeted by the monoclonal semorinemab. Importantly, these epitopes include an epitope specific to pTau, which is the pathological form of Tau protein responsible for the formation of tangles in AD. Additionally, the antibodies generated by this active immunization approach have pharmacokinetic properties that differ from those of injected semorinemab.
    • ACI-3024 (anti-Tau inhibitor): ACI-3024 is a first-in-class small molecule that passes through cell membranes to allow for the inhibition of intracellular Tau aggregates, which is not easily achieved with a large antibody like semorinemab. Phase 1 results in healthy volunteers and data disclosure are expected by Eli Lilly and Company in 2020.
    • Tau- PET tracer: AC Immune's Tau-PET tracer has the potential to work as a critical tool in the further development of anti-Tau approaches by facilitating the design of clinical trials that hit on two key aspects of AC Immune's Roadmap to Successful Therapies for Neurodegenerative Diseasestreating earlier and targeting more homogeneous populations. PI-2620 is currently being evaluated in a longitudinal Phase 2 study in patients with AD and a Phase 1 study (test/retest) in patients with progressive supranuclear palsy (PSP).

    Details of the TAURIEL study

    The Phase 2 TAURIEL study of semorinemab is a 73-week, double-blind, placebo-controlled trial to determine if it can slow the rate of clinical decline in early (prodromal to mild) AD. The study followed 457 participants across 97 study centers. The study did not meet the primary efficacy endpoint of reducing decline on Clinical Dementia Rating-Sum of Boxes (CDR-SB) compared to placebo, but did meet the primary safety endpoint. Overall, the incidence of adverse events was similar between semorinemab and placebo arms and further analysis of these safety data are currently underway. Two secondary endpoints, Alzheimer's Disease Assessment Scale-Cognitive Subscale 13 (ADAS-Cog13) and Alzheimer's Disease Cooperative Study Group – Activities of Daily Living Inventory (ADCS-ADL) also were not met. Analysis of additional data, including biomarkers such as Tau-PET, are ongoing and Genentech plans to present the results from the study at an upcoming medical congress. The second Phase 2 (LAURIET) study of semorinemab, in a different patient population, moderate AD, is ongoing.

    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 Genentech, a member of the Roche Group, Eli Lilly and Company and Janssen Pharmaceuticals.

    For further information, please contact:

    Head of Investor Relations

    Joshua Drumm, Ph.D.

    AC Immune

    Phone: +1 917 809 0814

    Email:



    US Media

    Katie Gallagher

    LaVoie Health Science

    Phone: +1 617 792 3937

    Email:



    Global Head of Communications

    Judith Moore

    AC Immune

    Phone: +41 79 826 63 82

    Email:
    European Investors & Media

    Chris Maggos

    LifeSci Advisors

    Phone: +41 79 367 6254

    Email:

    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.

    Photos accompanying this announcement are available at

    https://www.globenewswire.com/NewsRoom/AttachmentNg/13290144-c3a0-4e65-b079-eb5cc2484149

    https://www.globenewswire.com/NewsRoom/AttachmentNg/bc21e9b8-1152-488a-b719-cb667d4cf9ab

     

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  19. LAUSANNE, Switzerland, Sept. 11, 2020 (GLOBE NEWSWIRE) -- AC Immune SA (NASDAQ:ACIU), a Swiss-based, clinical-stage biopharmaceutical company with a broad pipeline focused on neurodegenerative diseases, today announced that it will showcase recent progress in its clinical programs targeting Tau for neurodegenerative diseases at the upcoming H.C. Wainwright 22nd Annual Global Investment Conference.

    AC Immune CEO Prof. Andrea Pfeifer, Ph.D., will discuss the Company's comprehensive anti-Tau clinical pipeline, which leads the industry in addressing this important neurodegenerative pathology. The extent of Tau pathology correlates very strongly with clinical decline throughout the course of disease, and AC Immune's three clinical-stage therapeutic…

    LAUSANNE, Switzerland, Sept. 11, 2020 (GLOBE NEWSWIRE) -- AC Immune SA (NASDAQ:ACIU), a Swiss-based, clinical-stage biopharmaceutical company with a broad pipeline focused on neurodegenerative diseases, today announced that it will showcase recent progress in its clinical programs targeting Tau for neurodegenerative diseases at the upcoming H.C. Wainwright 22nd Annual Global Investment Conference.

    AC Immune CEO Prof. Andrea Pfeifer, Ph.D., will discuss the Company's comprehensive anti-Tau clinical pipeline, which leads the industry in addressing this important neurodegenerative pathology. The extent of Tau pathology correlates very strongly with clinical decline throughout the course of disease, and AC Immune's three clinical-stage therapeutic assets - an antibody, a small molecule inhibitor, and a vaccine - collectively target the full spectrum of Tau pathology by inhibiting both early intracellular Tau aggregation and extracellular seeding and spreading of pathological Tau protein. Prof. Pfeifer will also discuss recently published results demonstrating the ability of its differentiated Tau positron emission tomography (PET) imaging agent PI-2620, which was discovered in a research collaboration with Life Molecular Imaging, to potentially facilitate an earlier and more reliable diagnosis of patients with progressive supranuclear palsy (PSP).

    H.C. Wainwright 22nd Annual Global Investment Conference

    Date: September 15, 2020 | 10:00–10:20 am ET / 4:00–4:20 pm CET

    Format: Virtual Presentation followed by Q&A

    Presenter: Prof. Andrea Pfeifer, CEO, AC Immune SA

    The presentation will be followed by a question and answer session. A webcast of the presentation and Q&A will be available on the Events Page of AC Immune's website.

    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, SupraAntigen™ and Morphomer™, 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 Genentech, a member of the Roche Group, Eli Lilly and Company and Janssen Pharmaceuticals.

    For further information, please contact:

    Head of Investor Relations

    Joshua Drumm, Ph.D.

    AC Immune

    Phone: +1 917 809 0814

    Email:



    US Media

    Katie Gallagher

    LaVoie Health Science

    Phone: +1 617 792 3937

    Email:



    Global Head of Communications

    Judith Moore

    AC Immune

    Phone: +41 79 826 63 82

    Email:



    European Investors & Media

    Chris Maggos

    LifeSci Advisors

    Phone: +41 79 367 6254

    Email:

    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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    • Substantial progress achieved across three anti-Tau clinical development programs; all clinical and preclinical programs remain on track to generate value in the second half of 2020
    • Top line Phase 2 data expected in the second half of 2020 for anti-Tau antibody semorinemab
    • CHF 262.5 million in cash ensures operations are fully financed through Q1 2024
    • Michael J. Fox Foundation (MJFF) award of USD 3.2 million (CHF 3.1 million) to support our alpha-synuclein positron emission tomography-(PET) tracer program for Parkinson's disease (PD) diagnostics

    LAUSANNE, Switzerland, Aug. 05, 2020 (GLOBE NEWSWIRE) -- AC Immune SA (NASDAQ:ACIU), a Swiss-based, clinical-stage biopharmaceutical company with a broad pipeline focused on neurodegenerative diseases…

    • Substantial progress achieved across three anti-Tau clinical development programs; all clinical and preclinical programs remain on track to generate value in the second half of 2020
    • Top line Phase 2 data expected in the second half of 2020 for anti-Tau antibody semorinemab
    • CHF 262.5 million in cash ensures operations are fully financed through Q1 2024
    • Michael J. Fox Foundation (MJFF) award of USD 3.2 million (CHF 3.1 million) to support our alpha-synuclein positron emission tomography-(PET) tracer program for Parkinson's disease (PD) diagnostics

    LAUSANNE, Switzerland, Aug. 05, 2020 (GLOBE NEWSWIRE) -- AC Immune SA (NASDAQ:ACIU), a Swiss-based, clinical-stage biopharmaceutical company with a broad pipeline focused on neurodegenerative diseases, today announced financial results for the Q2 2020 and provided a business update.  The Company ended the second quarter with CHF 262.5 million in cash, which ensures operations are fully financed through Q1 2024 with the potential to achieve multiple clinical milestones and create substantial value inflection.

    Prof. Andrea Pfeifer, CEO of AC Immune SA, commented: "AC Immune has delivered outstanding pipeline progress in Q2 2020, having achieved meaningful milestones across all three of our anti-Tau therapeutic programs including initiation of the second highest dosing group in our Phase 1b/2a clinical trial evaluating ACI-35.030, our vaccine candidate for the treatment of Alzheimer's disease (AD). In addition, we are proud to report that all of our programs continue to advance on schedule and additional substantial clinical data readouts continue to be anticipated in the second half of 2020, including top line Phase 2 data for our anti-Tau antibody semorinemab, from our partner Genentech, a member of the Roche group.

    "This strong clinical execution is mirrored by the productivity of our SupraAntigenTM and MorphomerTM discovery platforms, which continue to enable us to advance additional novel candidates against high value therapeutic targets, such as TDP-43, alpha-synuclein, and neuroinflammation. To achieve multiple clinical and preclinical therapeutic and diagnostic milestones in the first half of this year as planned – during the global pandemic – is truly exceptional and it shines a light on the diligence and dedication of our team and collaborators as well as the cutting-edge science fueling our pipeline.

    "We continue to maintain our strong cash position as we advance our development pipeline and we are well positioned to capture additional value from the new projects out of the SupraAntigenTM and MorphomerTM platforms, as we are already doing with our partnered programs. Complementing our achievements this quarter, results published in JAMA Neurology provide important clinical validation of the unique diagnostic potential of our Tau-PET tracer PI-2620, which is being developed in collaboration with Life Molecular Imaging, for patients with progressive supranuclear palsy (PSP). We are especially proud that our alpha-synuclein-PET tracer program was awarded USD 3.2 million by the MJFF Ken Griffin Alpha-synuclein Imaging Competition.  This tracer program is recognized as the most advanced in the field and could deliver the world's first imaging agent capable of accurately detecting and monitoring progression of PD."   

    Q2 2020 Research & Development Highlights:

    • Initiation of investigational new drug (IND)-enabling studies for the Company's first-in-class therapeutic antibody targeting TDP-43. The anti-TDP-43 antibody is the first therapeutic candidate shown to mitigate TDP-43 neuropathology in vivo and the Company plans to develop the antibody for the treatment of NeuroOrphan indications
    • AC Immune is one of three winners sharing USD 10 million through The Michael J. Fox Foundation Ken Griffin Alpha-synuclein Imaging Competition. The funding will support the nonclinical and clinical investigation of the Company's alpha-synuclein-PET tracers, which are the most advanced in the field and could deliver the world's first imaging agent capable of accurately detecting and monitoring progression of PD
    • New data presented at the Alzheimer's Association International Conference (AAIC) on the next generation alpha-synuclein-PET tracer shows enhanced contrast and alpha-synuclein target specificity, putting AC Immune's tracer in a strong position to become a first-in-class precision diagnostic tool for PD. AC Immune anticipates advancing its lead compound toward clinical stage development in Q4 2020
    • Announced the initiation of the second highest dosing group in the Company's Phase 1b/2a clinical trial evaluating ACI-35.030. The vaccine candidate, which is being developed in collaboration with Janssen Pharmaceuticals, Inc., is the first clinical candidate designed to generate a specific antibody response against pathological phospho-Tau (pTau) proteins in the brain. The decision to advance to the higher dosing group follows encouraging interim safety, tolerability and immunogenicity results from the initial dosing group
    • Results of an observational clinical study published in JAMA Neurology showed that PI-2620, an investigational Tau-PET tracer, can facilitate an earlier and more reliable diagnosis of PSP
    • Presented the cutting-edge science behind AC Immune's therapeutic and diagnostic programs in TDP-43 and alpha-synuclein, which are amongst the most comprehensive in the field, to investors at the UBS Virtual Healthcare Conference. Both targets are considered to be major pathologies in neurodegenerative diseases and are increasingly thought to be important co-pathologies in AD and PD

    Update on Covid-19

    The Swiss Government's management of Covid-19 has allowed businesses to be able to return to near normal working practices, with all AC Immune staff now back on site in Lausanne. AC Immune remains in continuous contact with its partners and other important stakeholders, including the Swiss government, trial investigators and contractors, and at this stage the Company is not modifying guidance with respect to the multiple clinical and preclinical data readouts anticipated this year. AC Immune will continue to keep the market apprised of any new developments or information that may impact clinical timelines.

    Analysis of Financial Statements for the Three and Six Months Ended June 30, 2020

    • Revenues: Revenues for the three and six months ended June 30, 2020 totaled CHF 1.3 million and CHF 13.7 million, respectively. This represents a decrease of CHF 0.2 million and CHF 62.9 million over the comparable periods in 2019. The decrease for the three months ended June 30, 2020 relates to a decrease of CHF 0.6 million in our collaboration with Janssen and other partners offset by a CHF 0.4 million increase with Eli Lilly and Company. The decrease for the six months ended June 30, 2020 predominantly relates to CHF 74.3 million recognized in the prior period associated with our license agreement with Lilly offset by a recognition of a CHF 10 million milestone payment and CHF 2.9 million for research and development activities performed in the current period  
    • R&D Expenditures: For the three and six months ended June 30, 2020, R&D expenses increased by CHF 0.1 million (+1%) and CHF 3.7 million (+15%) to CHF 12.9 million and CHF 28 million, respectively. For R&D expenses directly allocated to R&D programs, the Company increased investments in its non-AD programs predominantly led by increases in ACI-24 in Down syndrome related to scaling up activities for a Phase 2 clinical study. For AD, the Company's expenditures for ACI-24 in AD decreased due to the advanced status of the second generation vaccine technology

      Additionally, personnel costs in R&D increased by CHF 0.7 million and CHF 1.3 million through an increase in total 15 FTEs for the three and six months ended June 30, 2020, respectively. The remaining increases of CHF 0.3 million and CHF 0.9 million relate to an increase in regulatory and quality assurance and other unallocated research and development costs
    • G&A Expenses: For the three and six months ended June 30, 2020, G&A increased CHF 0.6 million (+16%) and CHF 1.8 million (+26%) to CHF 4.2 million and CHF 8.7 million, respectively. Increases were driven by an addition of seven FTEs as well as an increase in administrative and depreciation expenses
    • IFRS (Loss)/Income for the period: The Company incurred net loss after taxes of CHF 15.7 million and CHF 23.4 million for the three and six months ended June 30, 2020, respectively, compared with a net loss of CHF 16.9 million and net income of CHF 46.7 million for the comparable periods in 2019, predominantly as a result of the CHF 74.3 million of revenues recognized from our Lilly collaboration in 2019
    • Cash Position: The Company had a total cash balance of CHF 262.5 million, comprised of CHF 177.5 million in cash and cash equivalents and CHF 85 million in short-term financial assets. This compares to a total cash balance of CHF 288.6 million as of December 31, 2019. This decrease of CHF 26.1 million is principally due to the factors noted above in the income statement which resulted in a CHF 23.4 million net loss for the period and changes in our working capital. Further details are available in our Statements of Cash Flows on the accompanying Form 6-K

    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 Genentech, a member of the Roche group, Eli Lilly and Company, and Janssen Pharmaceuticals.

    For further information, please contact:

    Head of Investor Relations

    Joshua Drumm, Ph.D.

    AC Immune

    Phone: +1 917 809 0814

    Email:

    US Media

    Katie Gallagher

    LaVoieHealthScience

    Phone: +1 617 792 3937

    Email:



    Global Head of Communications

    Judith Moore

    AC Immune

    Phone: +41 79 826 63 82

    Email:

    European Investors & Media

    Chris Maggos

    LifeSci Advisors

    Phone: +41 79 367 6254

    Email:

    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.

    Balance Sheets

    (in CHF thousands)

     As of June 30,

    2020
     As of December 31,

    2019
    ASSETS   
    Non-current assets    
    Property, plant and equipment3,770  3,917 
    Right-of-use assets2,040  2,255 
    Long-term financial assets304  304 
    Total non-current assets  6,114  6,476 
         
    Current assets    
    Prepaid expenses3,689  2,788 
    Accrued income424  1,095 
    Other current receivables567  304 
    Short-term financial assets85,000  95,000 
    Cash and cash equivalents177,464  193,587 
    Total current assets  267,144  292,774 
    Total assets273,258  299,250 
         
    SHAREHOLDERS' EQUITY AND LIABILITIES    
         
    Shareholders' equity    
    Share capital1,438  1,437 
    Share premium346,634  346,526 
    Accumulated losses(97,210) (75,521)
    Total shareholders' equity250,862  272,442 
         
    Non-current liabilities    
    Long-term lease liabilities1,602  1,813 
    Net employee defined benefit liabilities7,847  7,485 
    Total non-current liabilities  9,449  9,298 
         
    Current liabilities    
    Trade and other payables1,442  142 
    Accrued expenses9,339  11,797 
    Short-term deferred income1,407  4,477 
    Short-term financing obligation321  652 
    Short-term lease liabilities438  442 
    Total current liabilities12,947  17,510 
    Total liabilities 22,396  26,808 
    Total shareholders' equity and liabilities  273,258  299,250 
          



    Statements of Income/(Loss)

    (in CHF thousands except for share and per share data)

     
     For the Three Months

    Ended June 30,
      For the Six Months

    Ended June 30,


     2020  2019   2020

      2019 
    Revenue           
    Contract revenue1,278  1,511  13,689  76,553 
    Total revenue  1,278  1,511  13,689  76,553 
                
    Operating expenses           
    Research & development expenses(12,809) (12,700) (28,018) (24,293)
    General & administrative expenses(4,156) (3,585) (8,660) (6,879)
    Total operating expenses  (16,965) (16,285) (36,678) (31,172)
    Operating income/(loss)  (15,687) (14,774) (22,989) 45,381 
             
    Finance expense, net(13) (1,732) (405) (1,812)
    Change in fair value of conversion feature  36    4,542 
    Interest income17  75  78  164 
    Interest expense(55) (504) (109) (1,601)
    Finance result, net  (51) (2,125) (436) 1,293 
             
    Income/(loss) before tax  (15,738) (16,899) (23,425) 46,674 
    Income tax expense       
    Income/(loss) for the period  (15,738) (16,899) (23,425) 46,674 
             
    Earnings/(loss) per share (EPS):        
    Basic income/(loss) for the period attributable to equity holders(0.22) (0.24) (0.33) 0.67 
    Diluted income/(loss) for the period attributable to equity holders(0.22) (0.24) (0.33) 0.67 
                



    Statements of Comprehensive Income/(Loss)For the Three Months

    ended June 30,


     For the Six Months

    ended June 30,


    (in CHF thousands) 2020  2019  2020  2019
            
    Income/(loss) for the period(15,738) (16,899) (23,425) 46,674
    Other comprehensive income/(loss) not to be reclassified to income or loss in subsequent periods (net of tax):       
    Re-measurement losses on defined benefit plans      
    Total comprehensive income/(loss), net of tax(15,738) (16,899) (23,425) 46,674
               



     
    Reconciliation of Income/(Loss) to Adjusted Income/(Loss) and
    Earnings/(Loss) Per Share to Adjusted Earnings/(Loss) Per Share
     
     For the Three Months

    Ended June 30,
    For the Six Months

    Ended June 30,
     2020  2019  2020  2019 
     (in CHF thousands except for share and per share data)
    Income/(Loss)(15,738) (16,899) (23,425) 46,674 
    Adjustments:           
    Non-cash share-based payments (a)995  561  1,847  1,146 
    Foreign currency losses (b)43  513  498  558 
    Effective interest expense (c)  364    1,355 
    Change in fair value of conversion feature (d)  (36)   (4,542)
    Adjusted Income/(Loss)(14,700) (15,497) (21,080) 45,191 
         
    Earnings/(Loss) per share – basic(0.22) (0.24) (0.33) 0.67 
    Earnings/(Loss) per share – diluted(0.22) (0.24) (0.33) 0.67 
    Adjustment to earnings/(loss) per share – basic0.02  0.02  0.04  (0.02)
    Adjustment to earnings/(loss) per share – diluted0.02  0.02  0.04  (0.02)
    Adjusted earnings/(loss) per share – basic(0.20) (0.22) (0.29) 0.65 
    Adjusted earnings/(loss) per share – diluted(0.20) (0.22) (0.29) 0.65 
    Weighted-average number of shares outstanding Adjusted earnings/(loss)–basic71,875,102  70,764,091  71,869,658  69,351,363 
    Weighted-average number of shares outstanding Adjusted earnings/(loss)–diluted71,875,102  70,764,091  71,869,658  69,845,858 



    (a)Reflects non-cash expenses associated with share-based compensation for equity awards issued to Directors, Management and employees of the Company. This expense reflects the awards' fair value recognized for the portion of the equity award which is vesting over the period.
    (b)Reflects foreign currency remeasurement gains and losses for the period, predominantly impacted by the change in the exchange rate between the US Dollar and the Swiss Franc.
    (c)Effective interest expense for the period relates to the accretion of the Company's convertible loan in accordance with the effective interest method.
    (d)Change in fair value of conversion feature that is bifurcated from the convertible loan host debt with Lilly.

    Adjustments for the three and six months ended June 30, 2020, adjustments were CHF 1.0 million and CHF 2.3 million in net losses compared with a decrease to net loss and net income of CHF 1.4 million and CHF 1.5 million for the comparable periods in 2019, respectively. The Company recorded CHF 1.0 million and CHF 1.8 million for the three and six months, respectively, for share-based compensation expenses. There were foreign currency remeasurement losses of less than CHF 0.1 million and CHF 0.5 million, respectively, predominantly related to the movement in our forward contract settled in Q2. For the three and six months ended June 30, 2019, the Company recorded CHF 0.4 million and CHF 1.4 million for amortization of effective interest and recognized less than CHF 0.1 million and a CHF 4.5 million gain for the change in fair value of the liability related to the conversion feature. These were not repeated in the current periods.

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  20. First-in-class TDP-43 antibody developed using SurpraAntigen™ platform

    The only TDP-43 antibody with reported in vivo activity

    LAUSANNE, Switzerland, Aug. 03, 2020 (GLOBE NEWSWIRE) -- AC Immune SA (NASDAQ:ACIU), a Swiss-based, clinical-stage biopharmaceutical company, with a broad pipeline focused on neurodegenerative diseases, today announced the initiation of investigational new drug (IND)-enabling studies for the Company's first-in-class therapeutic antibody targeting TDP-43 (TAR DNA-binding protein 43). The anti-TDP-43 antibody is the first therapeutic candidate shown to mitigate TDP-43 neuropathology in vivo and the Company plans to develop the antibody for the treatment of NeuroOrphan indications.

    Advancing the anti-TDP-43…

    First-in-class TDP-43 antibody developed using SurpraAntigen™ platform

    The only TDP-43 antibody with reported in vivo activity

    LAUSANNE, Switzerland, Aug. 03, 2020 (GLOBE NEWSWIRE) -- AC Immune SA (NASDAQ:ACIU), a Swiss-based, clinical-stage biopharmaceutical company, with a broad pipeline focused on neurodegenerative diseases, today announced the initiation of investigational new drug (IND)-enabling studies for the Company's first-in-class therapeutic antibody targeting TDP-43 (TAR DNA-binding protein 43). The anti-TDP-43 antibody is the first therapeutic candidate shown to mitigate TDP-43 neuropathology in vivo and the Company plans to develop the antibody for the treatment of NeuroOrphan indications.

    Advancing the anti-TDP-43 antibody towards clinical development is the latest in a series of important milestones already achieved this year in the Company's cutting-edge therapeutic and diagnostic programs targeting TDP-43 – which are amongst the most comprehensive in the field. TDP-43 pathology is strongly associated with cognitive decline and episodic memory loss in neurodegenerative diseases. Effectively slowing or stopping the spread of TDP-43 pathology throughout the brain could provide the first TDP-43 targeted therapeutic approach for treating conditions such as amyotrophic lateral sclerosis (ALS) and frontotemporal lobar degeneration with TDP-43 pathology (FTLD-TDP), where almost half of all FTLD cases exhibit TDP-43 pathology with  significant market potential for AC Immune's TDP-43 antibody. Other indications include limbic-predominant age-related TDP-43 encephalopathy (LATE), and sub-populations of argyrophilic grain disease and Lewy Body Dementia.  

    Additionally, pathological aggregation of TDP-43 has emerged as an important co-pathology in Alzheimer's disease linked to disease severity and occurring in ~50% of patients. Recognition that neurodegenerative diseases are driven by a complex interplay of pathologies highlights that successful treatments and cures will likely require combination therapy powered by precision medicine. This diversified approach is pioneered by AC Immune through parallel development of highly selective therapeutics and diagnostics for established targets like Tau and Abeta alongside newer targets such as TDP-43.

    Prof. Andrea Pfeifer, CEO of AC Immune SA, commented: "This milestone reinforces AC Immune's position as a leader in developing novel therapies against neurodegenerative diseases, with our anti-TDP-43 antibody on track to become the first in the world to reach clinical development. Aggregation of pathological forms of TDP-43 is an increasingly validated therapeutic target and a well-established hallmark of neurodegeneration. Initiation of IND-enabling studies for our first-in-class lead anti-TDP-43 antibody is a major step toward addressing pressing unmet need in NeuroOrphan indications.

    "The Company's success is driven in part by our proprietary SupraAntigen™ platform, which has already produced therapeutic monoclonal antibody candidates targeting Abeta and Tau that were successfully out-licensed to leading pharmaceutical companies and are currently advancing in multiple Phase 2 clinical studies. Advancement of the anti-TDP-43 antibody further validates the continuing productivity of this platform, which, together with our Morphomer™ platform for small molecule development, are responsible for discovery and development of our maturing pipeline of first-in-class or best-in-class therapeutic and diagnostic candidates."

    TDP-43 is an RNA/DNA-binding protein that functions primarily in the nucleus as a regulator of gene transcription and RNA metabolism. TDP-43 pathology has been shown to start from a focal point in the brain and spread to other brain regions with disease progression. Antibody-mediated clearance of pathological TDP-43 therefore represents an attractive strategy for therapeutic intervention – potentially slowing the spread by blocking the ability of pathological TDP-43 to seed aggregation in neighboring healthy cells. The anti-TDP-43 antibody binds all forms of TDP-43 with high affinity and is the only antibody with reported in vivo activity. Proof-of-concept data presented at the 2020 AAT-AD/PD™ Conference demonstrated anti-TDP-43 antibody's ability to mitigate TDP-43 neuropathology in a mouse model of TDP-43 proteinopathies.

    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, SupraAntigen™ and Morphomer™, 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 Genentech, a member of the Roche group, Eli Lilly and Company, and Janssen Pharmaceuticals.

    For further information, please contact:

    Head of Investor Relations

    Joshua Drumm, Ph.D.

    AC Immune

    Phone: +1 917 809 0814

    Email:

    US Media

    Katie Gallagher

    LaVoieHealthScience

    Phone: +1 617 792 3937

    Email:

      
    Global Head of Communications

    Judith Moore

    AC Immune

    Phone: +41 79 826 63 82

    Email:

    European Investors & Media

    Chris Maggos

    LifeSci Advisors

    Phone: +41 79 367 6254

    Email:

      

    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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  21. AC Immune is one of three winners sharing USD 10 million through The Michael J. Fox Foundation Ken Griffin Alpha-synuclein Imaging Competition

    The award follows compelling preclinical results presented at AAIC on the Company's alpha-synuclein positron emission tomography -(PET) tracer program

    Further validates the ability of AC Immune's proprietary platforms to accelerate delivery of a new class of promising diagnostics in neurodegenerative diseases

    LAUSANNE, Switzerland, July 30, 2020 (GLOBE NEWSWIRE) -- AC Immune SA (NASDAQ:ACIU), a Swiss-based, clinical-stage biopharmaceutical company with a broad pipeline focused on neurodegenerative diseases, today announced it is one of the winners of the Ken Griffin Alpha-synuclein Imaging Competition…

    AC Immune is one of three winners sharing USD 10 million through The Michael J. Fox Foundation Ken Griffin Alpha-synuclein Imaging Competition



    The award follows compelling preclinical results presented at AAIC on the Company's alpha-synuclein positron emission tomography -(PET) tracer program



    Further validates the ability of AC Immune's proprietary platforms to accelerate delivery of a new class of promising diagnostics in neurodegenerative diseases

    LAUSANNE, Switzerland, July 30, 2020 (GLOBE NEWSWIRE) -- AC Immune SA (NASDAQ:ACIU), a Swiss-based, clinical-stage biopharmaceutical company with a broad pipeline focused on neurodegenerative diseases, today announced it is one of the winners of the Ken Griffin Alpha-synuclein Imaging Competition from The Michael J. Fox Foundation for Parkinson's Research (MJFF), and is eligible to receive together with its partner USD 3.2 million (CHF 3.1 million).

    The funding will support the nonclinical and clinical investigation of AC Immune's proprietary alpha-synuclein-PET tracers, which are the most advanced in the field and could deliver the world's first imaging agent capable of accurately detecting and monitoring progression of Parkinson's disease (PD). The clinical arm of the AC Immune project will be conducted in partnership with Prof. Oskar Hansson's team of world-class researchers at Lund University and Skåne University Hospital in Sweden, which is a recognized Center of Excellence in the field of diagnostics for neurodegenerative diseases. Skåne University Hospital is eligible to receive USD 0.7 million over two years to support this arm of the project.

    Prof. Andrea Pfeifer, CEO of AC Immune SA, commented: "AC Immune is very proud to have attracted repeated support from MJFF over the last five years to advance development of alpha-synuclein-PET tracers. This award follows compelling preclinical results presented this week at the Alzheimer's Association International Conference (AAIC) on our next generation PET tracer which demonstrates enhanced contrast and alpha-synuclein target specificity, putting our tracer in a strong position to become a first-in-class precision diagnostic tool for Parkinson's disease (PD). This is a particularly important area of research, and this award really demonstrates the power of our innovative Morphomer™ discovery platform to accelerate the design, development and synthesis of conformation-specific small molecules. An effective alpha-synuclein PET tracer would enable and accelerate the development of new PD therapies as a powerful tool for measuring the effect of novel drugs on alpha-synuclein pathology in the brain."

    Jamie Eberling, Ph.D, Vice President of Research at MJFF, said: "The Foundation is committed to the development of an imaging tracer for Parkinson's. AC Immune has already advanced alpha-synuclein tracers to human clinical testing, and we look forward to its progress as it continues clinical testing and develops new tracers."

    The MJFF award for AC Immune's alpha-synuclein-PET program follows the announcement at this year's AAT-AD/PD™ conference that the Company's SupraAntigen™-derived anti-alpha-synuclein therapeutic antibody candidate has advanced into preclinical development to treat PD and other synucleinopathies. The combined potential of AC Immune's therapeutic and diagnostic programs is based on the Company's capabilities in precision medicine and may improve the diagnosis and treatment of alpha-synuclein pathologies, which are also of increasing interest in Alzheimer's disease (AD) and NeuroOrphan indications.

    Prof. Oskar Hansson, of Lund University and Skåne University Hospital said: "It would be a huge step forward if we succeed in the development of an accurate and reliable PET method for detection of alpha-synuclein pathology. Such a diagnostic method would be vital for increasing our understanding of the diseases, and more importantly it would facilitate the development of new disease modifying therapies that might halt, or even stop, the progression of PD."

    Prof. Pfeifer continued: "Our second generation alpha-synuclein-PET tracer started a first-in-human study last year and plans are in place to start another study to evaluate this tracer in genetic populations and, in parallel, advance a third generation candidate to clinical stage. With this latest award from MJFF, we look forward to advancing this important diagnostic program in collaboration with Prof. Hansson at Lund University and Skåne University Hospital."

    About AC Immune's alpha-synuclein programs

    Alpha-synuclein misfolding, aggregation and seeding are the molecular basis for the formation of Lewy bodies, a hallmark of PD, multiple system atrophy, and Lewy Body Dementia. Antibody-mediated clearance of pathological alpha-synuclein, including Lewy bodies, represents an attractive strategy for therapeutic intervention. Availability of non-invasive diagnostic tools like PET imaging agents would allow accurate diagnosis and monitoring of disease progression and would potentially enable longitudinal drug efficacy measurements in patients.

    AC Immune's PET tracers are derived from the Company's innovative Morphomer™ discovery platform, which accelerates the design, development and synthesis of conformation-specific small molecules to power successful diagnostic and therapeutic approaches. The Morphomer™ platform has produced multiple small molecules with clinical proof-of-concept that bind selectively to pathological forms of human proteins such as alpha-synuclein and Tau. It is complemented by AC Immune's SupraAntigen™ platform, which has generated clinically validated monoclonal antibodies and vaccines directed against pathological forms of Tau and Abeta. Together, these platforms have attracted partnerships with leading, global pharmaceutical companies, including Genentech, a member of the Roche group, Janssen Pharmaceuticals and Eli Lilly and Company, and have established AC Immune as an industry leader in the development of novel diagnostic and therapeutic agents for neurodegenerative diseases.

    About the Michael J. Fox Foundation Ken Griffin Alpha-synuclein Imaging Competition

    MJFF is the world's largest nonprofit funder of Parkinson's research with pioneering collaborations across industry, academia and government. This new award from the Ken Griffin Alpha-synuclein Imaging Competition is largely funded through a USD 7.5 million leadership gift from Ken Griffin, Founder and CEO of the Chicago-based global investment firm, Citadel, to incentivize research teams to race to develop a game-changing Parkinson's diagnostic tool. The USD 10 million Ken Griffin Alpha-synuclein Imaging Competition will be shared between three winning proposals in two rounds of funding with USD 8.5 million initially shared over two years. The final USD 1.5 million will then be awarded to the team that has progressed furthest to develop its program.

    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, SupraAntigen™ and Morphomer™, 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 Genentech, a member of the Roche group, Eli Lilly and Company and Janssen Pharmaceuticals.

    For further information, please contact:

    Head of Investor Relations

    Joshua Drumm, Ph.D.

    AC Immune

    Phone: +1 917 809 0814

    Email:

     
    US Media

    Katie Gallagher

    LaVoieHealthScience

    Phone: +1 617 792 3937

    Email:

     
    Global Head of Communications

    Judith Moore

    AC Immune

    Phone: +41 79 826 63 82

    Email:



    European Investors & Media

    Chris Maggos

    LifeSci Advisors

    Phone: +41 79 367 6254

    Email:



    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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  22. Next-generation PET tracer detects pathological alpha-synuclein with improved signal-to-noise ratio

    Oral presentation at AAIC further demonstrates the strength of AC Immune's Morphomer™ platform for generating highly selective small molecule diagnostics

    LAUSANNE, Switzerland, July 28, 2020 (GLOBE NEWSWIRE) -- AC Immune SA (NASDAQ:ACIU), a Swiss-based, clinical-stage biopharmaceutical company, with a broad pipeline focused on neurodegenerative diseases, today reported new data for its next generation alpha-synuclein positron emission tomography-(PET) tracer during an oral presentation at the Alzheimer's Association International Conference (AAIC) and anticipates advancing its lead compound toward clinical stage development in Q4 2020…

    Next-generation PET tracer detects pathological alpha-synuclein with improved signal-to-noise ratio

    Oral presentation at AAIC further demonstrates the strength of AC Immune's Morphomer™ platform for generating highly selective small molecule diagnostics

    LAUSANNE, Switzerland, July 28, 2020 (GLOBE NEWSWIRE) -- AC Immune SA (NASDAQ:ACIU), a Swiss-based, clinical-stage biopharmaceutical company, with a broad pipeline focused on neurodegenerative diseases, today reported new data for its next generation alpha-synuclein positron emission tomography-(PET) tracer during an oral presentation at the Alzheimer's Association International Conference (AAIC) and anticipates advancing its lead compound toward clinical stage development in Q4 2020.

    The compelling preclinical results demonstrate enhanced contrast and alpha-synuclein target specificity, putting AC Immune's PET tracer in a strong position to become a first-in-class precision diagnostic tool for Parkinson's disease (PD). No effective diagnostic agents exist today for PD and other alpha-synucleinopathies, such as multiple system atrophy (MSA), and Lewy Body Dementia (LBD), representing substantial unmet clinical need.

    Prof. Andrea Pfeifer, CEO of AC Immune SA, commented: "I am highly encouraged by these results, as they demonstrate AC Immune's industry-leading expertise in the development of alpha-synuclein-targeting agents. There is increasing recognition of the importance of targeting the right disease pathology at the right time in neurodegenerative diseases, and AC Immune continues to lead the way towards facilitating such an approach through the parallel development of therapeutic and diagnostic agents for important targets such as alpha-synuclein, as well as more well established targets like Tau and Abeta. The data presented at AAIC are a prime example of the power of our Morphomer™ platform to facilitate the rapid optimization of our PET tracers."

    Alpha-synuclein misfolding, aggregation and seeding are the molecular basis for the formation of Lewy bodies, a hallmark of PD, MSA, and LBD. The availability of non-invasive diagnostic tools that can distinguish alpha-synucleinopathies from other proteinopathies or normal physiological situations would enable – for the first time – accurate clinical diagnosis, monitoring of disease progression and benefits of drug interventions. ACI-12589 demonstrates significantly increased target occupancy compared to previous-generation candidates as well as a significantly improved signal specificity.

    AC Immune's PET tracers are derived from the Company's innovative Morphomer™ discovery platform, which accelerates the design, development and synthesis of conformation-specific small molecules to power successful diagnostic and therapeutic approaches. The Morphomer™ platform has produced multiple small molecules with clinical proof-of-concept that bind selectively to pathological forms of human proteins such as alpha-synuclein and Tau.

    Based on proof-of-concept data presented at this year's AAT-AD/PD™ conference, AC Immune announced that it advanced its SupraAntigen™-derived anti-alpha-synuclein therapeutic antibody candidate from discovery into preclinical development. The combined potential of AC Immune's therapeutic and diagnostic programs is based on the Company's capabilities in precision medicine and may improve the diagnosis and treatment of alpha-synuclein pathologies, which are of increasing interest in Alzheimer's disease (AD) and NeuroOrphan indications.

    Dr. Capotosti's presentation was titled Developing a novel alpha-synuclein positron emission tomography (PET) tracer for the diagnosis of a-synucleinopathies. Key highlights from the presentation include:

    • ACI-3847, a first-generation alpha-synuclein-PET tracer, showed good brain uptake and very low non-specific retention in a first-in-human study in idiopathic PD patients and healthy volunteers
    • The data on ACI-3847 suggested to test the PET tracer in alpha-synuclein-pathologies with higher levels of alpha-synuclein accumulation
    • AC Immune's Morphomer™ platform also led to the discovery of ACI-12589 with excellent target occupancy and signal specificity ex vivo and an expected optimal signal-to-noise ratio in patients
    • Data presented will show ACI-12589 as a potential first- and best-in-class imaging agent for the diagnosis of PD

    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, SupraAntigen™ and Morphomer™, 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 Genentech, a member of the Roche Group, Eli Lilly and Company and Janssen Pharmaceuticals.

    For further information, please contact:

    Head of Investor Relations

    Joshua Drumm, Ph.D.

    AC Immune

    Phone: +1 917 809 0814

    Email:

    US Media

    Katie Gallagher

    LaVoieHealthScience

    Phone: +1 617 792 3937

    Email:

      
    Global Head of Communications

    Judith Moore

    AC Immune

    Phone: +41 79 826 63 82

    Email:

    European Investors & Media

    Chris Maggos

    LifeSci Advisors

    Phone: +41 79 367 6254

    Email:

    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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  23. LAUSANNE, Switzerland, July 23, 2020 (GLOBE NEWSWIRE) -- AC Immune SA (NASDAQ:ACIU), a Swiss-based, clinical-stage biopharmaceutical company, with a broad pipeline focused on neurodegenerative diseases, today announced two oral presentations will be delivered at this year's Alzheimer's Association International Conference (AAIC) which takes place virtually July 27 – 31, 2020.

    Key data will be presented on the Company's alpha-synuclein-positron emission tomography (PET) tracer program along with a second oral presentation by the Coordinating Principal Investigator of the Phase 1b trial of the anti-Abeta vaccine ACI-24 in Down syndrome, Dr. Michael Rafii  – who is a world authority on Down syndrome-related Alzheimer's disease. Both research…

    LAUSANNE, Switzerland, July 23, 2020 (GLOBE NEWSWIRE) -- AC Immune SA (NASDAQ:ACIU), a Swiss-based, clinical-stage biopharmaceutical company, with a broad pipeline focused on neurodegenerative diseases, today announced two oral presentations will be delivered at this year's Alzheimer's Association International Conference (AAIC) which takes place virtually July 27 – 31, 2020.

    Key data will be presented on the Company's alpha-synuclein-positron emission tomography (PET) tracer program along with a second oral presentation by the Coordinating Principal Investigator of the Phase 1b trial of the anti-Abeta vaccine ACI-24 in Down syndrome, Dr. Michael Rafii  – who is a world authority on Down syndrome-related Alzheimer's disease. Both research programs are the most advanced in their field.

    Prof. Andrea Pfeifer, CEO of AC Immune SA, commented: "This year's AAIC presentations reflect the ongoing strength and depth of our industry leading pipeline. There is increasing recognition that the complexity of neurodegenerative disease pathology will only be solved utilizing the type of diversified approach pioneered by AC Immune. This is why our pipeline spans both cutting-edge therapeutic and diagnostic programs on well-established targets like Abeta, as well as novel targets and mechanisms.

    "Compelling results1 just published from the first large, multi-national study to track clinical and biomarker changes of Down syndrome-related Alzheimer's disease further validate the approach of testing our anti-Abeta vaccine ACI-24 in individuals with Down syndrome as a key population for trials to target Alzheimer's disease in genetic, more homogeneous populations.

    "The presentations further highlight the enduring power of our clinically validated proprietary Morphomer™ and SupraAntigen™ platforms to accelerate the discovery, design and development of novel medicines and diagnostics to target misfolded proteins."

    Scientific updates at the AAIC 2020 Virtual Event, July 27–31, 2020

    Alpha-synuclein PET tracer
    Title: Developing a novel alpha-synuclein-positron emission tomography (PET) tracer for the diagnosis of a-synucleinopathies
    Date: Tuesday, July 28, 2020 | 12:00am – 11:59pm
    Session: Neuroimaging: Other Neurodegenerative Disorders
    Presenter: Oral presentation by Dr. Francesca Capotosti



    ACI-24 anti-Abeta vaccine
    Title: ACI-24 Vaccine in Adults with Down Syndrome (3 Star Trial)
    Date: Wednesday, July 29, 2020 | 12:00 am – 11:59pm
    Session: Human: Putative Therapeutic Results for Alzheimer's and Related Dementias
    Presenter: Oral presentation by Dr. Michael Rafii, Alzheimer's Therapeutic Research Institute, Keck School of Medicine of University of Southern California

    References

    1. Fortea et al, Lancet 2020; 395: 1988–97

    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 Genentech, a member of the Roche group, Eli Lilly and Company and Janssen Pharmaceuticals.

    For further information, please contact:

    Head of Investor Relations

    Joshua Drumm, Ph.D.

    AC Immune

    Phone: +1 917 809 0814

    Email:

    US Media

    Katie Gallagher

    LaVoieHealthScience

    Phone: +1 617 792 3937

    Email:

      
    Global Head of Communications

    Judith Moore

    AC Immune

    Phone: +41 79 826 63 82

    Email:

    European Investors & Media

    Chris Maggos

    LifeSci Advisors

    Phone: +41 79 367 6254

    Email:

      

    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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  24. Interim data confirm the promising safety, tolerability and Tau-specific immunogenicity observed in the previous clinical study

    ACI-35.030 is a clinical stage vaccine generated with the proprietary SupraAntigen™ platform addressing proteinopathies across neurodegenerative diseases

    LAUSANNE, Switzerland, July 16, 2020 (GLOBE NEWSWIRE) -- AC Immune SA (NASDAQ:ACIU), a Swiss-based, clinical-stage biopharmaceutical company with a broad pipeline focused on neurodegenerative diseases, today announced the initiation of the second highest dosing group in the Company's Phase 1b/2a clinical trial evaluating ACI-35.030 for the treatment of Alzheimer's disease (AD). The decision to advance to the higher dosing group follows encouraging interim safety…

    Interim data confirm the promising safety, tolerability and Tau-specific immunogenicity observed in the previous clinical study

    ACI-35.030 is a clinical stage vaccine generated with the proprietary SupraAntigen™ platform addressing proteinopathies across neurodegenerative diseases

    LAUSANNE, Switzerland, July 16, 2020 (GLOBE NEWSWIRE) -- AC Immune SA (NASDAQ:ACIU), a Swiss-based, clinical-stage biopharmaceutical company with a broad pipeline focused on neurodegenerative diseases, today announced the initiation of the second highest dosing group in the Company's Phase 1b/2a clinical trial evaluating ACI-35.030 for the treatment of Alzheimer's disease (AD). The decision to advance to the higher dosing group follows encouraging interim safety, tolerability and immunogenicity results from the initial dosing group.

    Immunization with anti-Tau vaccines has become an important strategy for the treatment of AD and other neurodegenerative diseases characterized by Tau pathology. ACI-35.030, which is being developed in collaboration with Janssen Pharmaceuticals, Inc., is the first AD vaccine candidate designed to generate a specific antibody response against pathologic phospho-Tau (pTau) proteins in the brain. Anti-pTau antibodies generated by ACI-35.030 have the potential to reduce the spread and seeding of Tau pathology throughout the brain.

    Prof. Andrea Pfeifer, CEO of AC Immune SA, commented: "The fact that ACI-35.030 shows encouraging safety and immunogenicity at the lowest dose in this elderly patient population is highly meaningful and we look forward to quickly enrolling this next dosing group. Tau-targeted approaches may have a much broader therapeutic window to potentially disrupt, slow or prevent disease progression at both early and advanced disease stages. Pathological pTau occurs early in the disease process, years before accumulation of Tau deposits. Therefore, our pTau-targeting approach holds significant promise for the treatment of AD at different disease stages."

    This Phase 1b/2a trial is a randomized, multicenter, double-blind, placebo-controlled clinical study with a primary objective to assess the safety, tolerability and immunogenicity of different doses of ACI-35.030 over a 48-week treatment phase in patients with early AD. Other endpoints will assess clinical and cognitive parameters as well as additional immunogenicity and safety parameters.

    The ACI-35.030 anti-pTau vaccine is the second vaccine under investigation generated from AC Immune's SupraAntigen™ platform, along with ACI-24, a proprietary anti-amyloid beta (Abeta) vaccine currently in Phase 1b/Phase 2 clinical development in two separate indications. The Company's pipeline is also advancing two monoclonal antibodies, semorinemab, an anti-Tau antibody in Phase 2 development and crenezumab, an anti-Abeta antibody in Phase 2 development, both partnered with Genentech/Roche.

    About ACI-35.030

    ACI-35.030 is a potent liposomal anti-pTau active investigational vaccine designed to elicit antibodies against phosphorylated pathological Tau protein, in order to reduce and facilitate the clearance of related Tau aggregates, slowing the progression of Tau-pathology and/or treating the underlying Tauopathy.

    It builds on the success of AC Immune's ACI-35 vaccine, which demonstrated an early target-specific antibody response against pTau after the first injection in the vast majority of patients in a Phase 1b study in mild-to-moderate AD. In preclinical studies, ACI-35.030 retained the excellent non-clinical safety profile and the highly specific antibody response against phosphorylated pathological Tau produced by ACI-35, while demonstrating an enhanced and more homogeneous antibody response.

    AC Immune is developing the ACI-35.030 vaccine in collaboration with Janssen Pharmaceuticals, Inc. under a 2014 licensing agreement to develop and commercialize therapeutic anti-Tau vaccines for the treatment of AD and potentially other Tauopathies.

    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, SupraAntigen™ and Morphomer™, 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 Company, and Janssen Pharmaceuticals Inc.

    For further information, please contact:

    Head of Investor Relations

    Joshua Drumm, Ph.D.

    AC Immune

    Phone: +1 917 809 0814

    Email:

    US Media

    Katie Gallagher

    LaVoieHealthScience

    Phone: +1 617 792 3937

    Email:

      
    Global Head of Communications

    Judith Moore

    AC Immune

    Phone: +41 79 826 63 82

    Email:

    European Investors & Media

    Chris Maggos

    LifeSci Advisors

    Phone: +41 79 367 6254

    Email:

      

    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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  25. BERLIN and LAUSANNE, Switzerland, July 07, 2020 (GLOBE NEWSWIRE) -- Life Molecular Imaging and AC Immune SA (NASDAQ:ACIU) announce the publication of clinical data of the investigational Tau-positron emission tomography (PET) tracer PI-2620 in patients with progressive supranuclear palsy (PSP). The tracer is shown to be a promising biomarker for the improved detection and characterization of this currently untreatable, fatal disease.

    The observational study, which is published now in JAMA Neurology1, is a multi-center evaluation led by nuclear medicine physicians and neurologists from Munich and Leipzig, Germany, together with researchers at study sites in New Haven, Cologne and Melbourne. The results indicate that PI-2620 could facilitate…

    BERLIN and LAUSANNE, Switzerland, July 07, 2020 (GLOBE NEWSWIRE) -- Life Molecular Imaging and AC Immune SA (NASDAQ:ACIU) announce the publication of clinical data of the investigational Tau-positron emission tomography (PET) tracer PI-2620 in patients with progressive supranuclear palsy (PSP). The tracer is shown to be a promising biomarker for the improved detection and characterization of this currently untreatable, fatal disease.

    The observational study, which is published now in JAMA Neurology1, is a multi-center evaluation led by nuclear medicine physicians and neurologists from Munich and Leipzig, Germany, together with researchers at study sites in New Haven, Cologne and Melbourne. The results indicate that PI-2620 could facilitate an earlier and more reliable diagnosis of PSP, where previous Tau tracers and other biomarkers failed. The accumulation of 4R Tau protein deposits in specific brain regions is a pathological hallmark of PSP. PI-2620 shows signals in those regions of PSP patients and allows excellent discrimination from disease controls at the single-subject level by both visual inspection and quantitative analyses of brain scans.

    These new results in PSP further demonstrate PI-2620's excellent characteristics as a strong diagnostic tool for studying Tau-related diseases following recent publications about its capabilities in early and more advanced Alzheimer's disease2-6.

    PI-2620 was discovered in a research collaboration with Life Molecular Imaging and AC Immune, Life Molecular Imaging has the exclusive world-wide license for research, development and commercialization of Tau-PET tracers generated within the discovery program. PI-2620 is currently under investigation in several clinical studies as a targeted radiopharmaceutical for the detection of Tau deposits in the human brain.

    Dr. Andrew Stephens, Chief Medical Officer at Life Molecular Imaging, said: "This large multi-center study demonstrates the power of PI-2620 as a biomarker to study 4R Tau-related diseases like PSP. The detection and monitoring of the underlying Tau pathology with PI-2620 for both 4R-Tauopathies like PSP and corticobasal degeneration (CBD), as well as 3R/4R Tauopathies like Alzheimer's disease will advance the field, leading to appropriate patient selection and monitoring target engagement in clinical trials of emerging therapeutic agents."

    Prof. Andrea Pfeifer, CEO of AC Immune SA, added: "This real-world study provides first evidence that PI-2620 could provide an earlier and more accurate diagnosis of PSP. Highly specific PET tracers are a critical tool in the patient pathway to achieve an accurate diagnosis, a particular challenge in the complex spectrum of neurodegenerative disorders and often not achievable through clinical presentation alone. Such capabilities would enable early, targeted therapeutic interventions for PSP patients and enhance the research community's ability to better advance more effective treatments and cures."

    PSP is an orphan disease that affects up to 18 out of every 100,000 individuals worldwide. Patients can be challenging to diagnose because they show symptoms, such as movement difficulties, stiffness, clumsiness, cognitive impairment and frequent falls that are also present in many neurodegenerative diseases, like Parkinson's disease (PD). Misdiagnosis of PSP hampers drug development due to heterogeneous study populations, mixing patients with Tau-related pathologies and patients suffering from other proteinopathies.

    References

    1. Brendel et al. "Assessment of 18F-PI-2620 as a Biomarker in Progressive Supranuclear Palsy" JAMA Neurology online first: 

      https://jamanetwork.com/journals/jamaneurology/fullarticle/2768084
    2. Kroth et al. "Discovery and Preclinical Characterization of 18F-PI-2620, a Next-Generation Tau PET Tracer for the Assessment of Tau Pathology in Alzheimer's Disease and Other Tauopathies" Eur J Nucl Med Mol Imaging. 2019 Sep;46(10):2178-2189
    3. Mueller et al., "Tau PET imaging with 18F-PI-2620 in Patients with Alzheimer Disease and Healthy Controls: A First-in-Humans Study" J Nucl Med. 2020 Jun;61(6):911-919
    4. Bullich et al., "Evaluation of Dosimetry, Quantitative Methods, and Test-Retest Variability of 18F-PI-2620 PET for the Assessment of Tau Deposits in the Human Brain" J Nucl Med. 2020 Jun;61(6):920-927
    5. Beyer et al., "Early-phase 18F-PI-2620 tau-PET imaging as a surrogate marker of neuronal injury" Eur J Nucl Med Mol Imaging. 2020 Apr 21. https://doi.org/10.1007/s00259-020-04788-w Online ahead of print
    6. Mormino et al., "Tau PET imaging with 18F-PI-2620 in aging and neurodegenerative diseases". Eur J Nucl Med Mol Imaging. 2020 Jun 23. https://doi.org/10.1007/s00259-020-04923-7 Online ahead of print

    About Life Molecular Imaging (LMI)

    LMI (formerly Piramal Imaging) was formed in 2012 with the acquisition of the molecular imaging research and development portfolio of Bayer Pharma AG, and is now part of the Alliance Medical Group, an integrated business including research and development laboratories, a network of cyclotrons, radiopharmacies and imaging facilities. By developing novel PET tracers for molecular imaging, LMI is focusing on a key field of modern medicine. LMI strives to be a leader in the Molecular Imaging field by developing innovative products that improve early detection and characterization of chronic and life-threatening diseases, leading to better therapeutic outcomes and improved quality of life. Please visit: https://life-mi.com

    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.

    For further information, please contact:

    Head of Investor Relations

    Joshua Drumm, Ph.D.

    AC Immune

    Phone: +1 917 809 0814

    Email:



     
    US Media

    Katie Gallagher

    LaVoieHealthScience

    Phone: +1 617 792 3937

    Email:



     
    Global Head of Communications

    Judith Moore

    AC Immune

    Phone: +41 79 826 63 82

    Email:



     
    European Investors & Media

    Chris Maggos

    LifeSci Advisors

    Phone: +41 79 367 6254

    Email:



     
    Global Head of Communications

    Nicole Fletcher

    Life Molecular Imaging

    Phone: +1 857-202-1122

    Email:

    Scientific Operations

    Norman Koglin

    Life Molecular Imaging

    Phone: +49 30 461 124 606

    Email:

    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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  26. LAUSANNE, Switzerland, June 26, 2020 (GLOBE NEWSWIRE) -- 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…

    LAUSANNE, Switzerland, June 26, 2020 (GLOBE NEWSWIRE) -- 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.

    For further information, please contact:

    Head of Investor Relations

    Joshua Drumm, Ph.D.

    AC Immune

    Phone: +1 917 809 0814

    Email:



     
    US Media

    Katie Gallagher

    LaVoieHealthScience

    Phone: +1 617 792 3937

    Email:



     
    Global Head of Communications

    Judith Moore

    AC Immune

    Phone: +41 79 826 63 82

    Email:



     
    European Investors & Media

    Chris Maggos

    LifeSci Advisors

    Phone: +41 79 367 6254

    Email:



     

    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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  27. LAUSANNE, Switzerland, May 15, 2020 (GLOBE NEWSWIRE) -- AC Immune SA (NASDAQ:ACIU), a Swiss-based, clinical-stage biopharmaceutical company with a broad pipeline focused on neurodegenerative diseases, today announced that it will showcase key programs focused on novel targets in neurodegenerative diseases at next week's UBS Virtual Global Healthcare Conference (May 18–20, 2020).

    Speaking on May 20th, Prof. Andrea Pfeifer, Ph.D., CEO of AC Immune SA, will outline the cutting-edge science behind AC Immune's therapeutic and diagnostic programs in TDP-43 and alpha-synuclein – which are amongst the most comprehensive in the field. Both targets are considered to be major pathologies in neurodegenerative diseases, and increasingly thought to be important…

    LAUSANNE, Switzerland, May 15, 2020 (GLOBE NEWSWIRE) -- AC Immune SA (NASDAQ:ACIU), a Swiss-based, clinical-stage biopharmaceutical company with a broad pipeline focused on neurodegenerative diseases, today announced that it will showcase key programs focused on novel targets in neurodegenerative diseases at next week's UBS Virtual Global Healthcare Conference (May 18–20, 2020).

    Speaking on May 20th, Prof. Andrea Pfeifer, Ph.D., CEO of AC Immune SA, will outline the cutting-edge science behind AC Immune's therapeutic and diagnostic programs in TDP-43 and alpha-synuclein – which are amongst the most comprehensive in the field. Both targets are considered to be major pathologies in neurodegenerative diseases, and increasingly thought to be important co-pathologies in Alzheimer's disease and Parkinson's disease.  This highlights the need for the precision medicine approach pioneered by AC Immune to achieve earlier and more accurate diagnosis. 

    In addition to the Company's TDP-43 and alpha-synuclein targeting programs, the presentation will also detail advances for the clinical stage assets addressing the well-established pathophysiology mediated by Tau and Abeta. The critical role of the Company's two proprietary platforms, SupraAntigen™ and Morphomer™, in fueling advances for antibodies and small molecules, respectively, will also be highlighted.

    UBS Virtual Global Healthcare Conference
    Date: May 20, 2020 | 9:10–10:00 am ET/ 3:10–4:00 pm CET
    Format: Virtual presentation
    Presenter: Prof. Andrea Pfeifer, CEO, AC Immune SA

    A webcast of the presentation will be available on the Events Page of AC Immune's website.

    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, SupraAntigen™ and Morphomer™, 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.

    For further information, please contact:

    Head of Investor Relations
    Joshua Drumm, Ph.D.
    AC Immune
    Phone: +1 917 809 0814
    Email:
    US Media
    Katie Gallagher
    LaVoieHealthScience
    Phone: +1 617 792 3937
    Email:
       
    Global Head of Communications
    Judith Moore
    AC Immune
    Phone: +41 79 826 63 82
    Email:
    European Investors & Media
    Chris Maggos
    LifeSci Advisors
    Phone: +41 79 367 6254
    Email:

    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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    • On track to meet the five clinical milestones expected in 2020 with no modifying guidance as a result of Covid-19

    • Ongoing strong financial position with CHF 277.9 million in cash, ensuring the Company is fully financed through Q1 2024, excluding potential incoming milestones

    • Added new potential CHF 60 million Phase 2 initiation milestone for the small molecule Morphomer™ Tau aggregation inhibitor program and received CHF 10 million milestone in Q1 2020 in Lilly partnership

    • Advanced a lead anti-alpha-synuclein therapeutic antibody candidate into preclinical development based on new proof-of-concept data presented at AAT-AD/PDTM

    LAUSANNE, Switzerland, May 04, 2020 (GLOBE NEWSWIRE) -- AC Immune SA (NASDAQ:ACIU), a Swiss-based, clinical-stage…

    • On track to meet the five clinical milestones expected in 2020 with no modifying guidance as a result of Covid-19

    • Ongoing strong financial position with CHF 277.9 million in cash, ensuring the Company is fully financed through Q1 2024, excluding potential incoming milestones

    • Added new potential CHF 60 million Phase 2 initiation milestone for the small molecule Morphomer™ Tau aggregation inhibitor program and received CHF 10 million milestone in Q1 2020 in Lilly partnership

    • Advanced a lead anti-alpha-synuclein therapeutic antibody candidate into preclinical development based on new proof-of-concept data presented at AAT-AD/PDTM

    LAUSANNE, Switzerland, May 04, 2020 (GLOBE NEWSWIRE) -- AC Immune SA (NASDAQ:ACIU), a Swiss-based, clinical-stage biopharmaceutical company with a broad pipeline focused on neurodegenerative diseases, today announced financial results for the first quarter ended March 31, 2020 and provided a business and 2020 research and development update.

    Prof. Andrea Pfeifer, CEO of AC Immune SA, commented: "AC Immune has had a strong start to 2020. We received a second milestone payment and expanded our transformative agreement with Eli Lilly and Company, further reinforcing our position as one of the most influential biotechnology companies targeting neurodegenerative diseases.

    "With increasing recognition that precision medicine is likely to be the best way to address the complexity of neurodegenerative disease (NDD) pathology, one of AC Immune's key strengths is our diversified approach. New proof-of-concept data presented at this year's AAT-AD/PDTM reflects that alongside programs advancing on well-established targets like Tau and Abeta, we are also focused on novel targets and mechanisms. Our TDP-43 and alpha-synuclein therapeutic and diagnostic programs are amongst the most advanced in the field, as it becomes clear that co-pathologies in AD and NDD are an important element in the route to a cure.

    "We continue to believe that 2020 will be an important and eventful year for AC Immune and for the entire field of neurodegenerative diseases, despite the challenges posed by the Covid-19 pandemic. Our continued strong cash position of CHF 277.9 million provides a solid foundation with the Company being fully financed through at least Q1 2024. And we remain on track to meet multiple value-creating milestones this year, with five clinical readouts, including the first Phase 2 proof-of-concept data for semorinemab, an anti-Tau antibody, through our partnership with Genentech, a member of the Roche group."

    Q1 2020 Research & Development Highlights:

    • Presented new preclinical data at the first ever online AAT-AD/PD™ Focus, describing proof-of-concept data for lead candidates in AC Immune's therapeutic and diagnostic programs targeting TDP-43 and alpha-synuclein. These pathological proteins represent targets of increasing interest for the treatment of neurodegenerative diseases, and AC Immune's programs are amongst the most advanced in the field
    • Dr. Juan Fortea, an internationally renowned neurologist with a specific focus in the emerging field of Down syndrome-related Alzheimer's disease, joined AC Immune's Clinical Advisory Board (CAB)
    • Received a second milestone payment of CHF 10 million from Lilly related to development progress in the small molecule Morphomer™ Tau aggregation inhibitor program. Under updated collaboration terms, AC Immune is now 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 Morphomer™ Tau 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

    2020 Research & Development Outlook
    The coming years will be transformational for the field of neuroscience and AC Immune is poised to make significant clinical contributions, capturing substantial interest and value in 2020 and beyond. The Company expects to deliver multiple near-term catalysts, including results from five clinical trials in 2020. The Company's sustained growth is being fueled by its proprietary discovery platforms, SupraAntigen™ and Morphomer™, and driven by its industry-leading strategy, summarized in AC Immune's Roadmap to Successful Therapies for Neurodegenerative Diseases.

    2020 Clinical Readouts

    • Semorinemab, anti-Tau antibody: Phase 2 trial primary completion (estimated last patient, last visit) in prodromal/mild in Q2
    • ACI-24 anti-Abeta vaccine in Down syndrome (DS): Phase 1b full study reporting in H2
    • ACI-35.030 anti-pTau vaccine: Phase 1b/2a in AD interim analysis in Q2
    • ACI-3024 small molecule Morphomer™ Tau aggregation inhibitor: Phase 1 results in healthy volunteers in Q2; data disclosed by Lilly in H2 (expected)
    • ACI-24 in AD: Phase 2, 12-month interim analysis in H2

    2020 Preclinical Milestones

    • Alpha-synuclein antibody: started investigational new drug (IND)-enabling studies for lead candidate in Q1 (achieved)
    • Anti-TDP-43 antibody: declare clinical lead and start IND-enabling studies in Q2
    • Alpha-synuclein small molecule: identify first biologically active small molecule in Q2
    • Alpha-synuclein imaging agent: advance third generation candidate to clinical stage in Q4
    • Neuroinflammation: declare lead candidates for small molecule and antibody programs in Q4

    Update on Covid-19
    AC Immune has always maintained a robust business continuity plan. During the Covid-19 outbreak, every provision is being made to protect the health of patients, staff and investigators, as well as the productivity and integrity of our clinical development. Importantly, the Company currently remains on track to deliver the five clinical readouts expected in 2020, owing largely to the fact that many of the Company's key trials are already fully enrolled, and patient follow up is continuing virtually. AC Immune notes the following additional considerations related to Covid-19:

    • The 12-month interim data analysis for ACI-24 in AD will proceed as planned on a reduced patient data-set

    • Plans to initiate a Phase 2 study of ACI-24 in DS in the second half of 2020 are progressing and will be initiated in line with public health guidance at that time 

    • Dosing of participants in the Phase 2 Colombian Alzheimer's disease prevention initiative (API) study has been temporarily interrupted by the countrywide stay at home order. While the ultimate duration of the dosing interruption is not yet known, participants are receiving crenezumab or placebo for at least five years as part of the long-term prevention study, and we continue to expect data from the study in 2022

    There are positive signs that countries, including Switzerland, are beginning to ease restrictions. AC Immune remains in continuous contact with its partners and other important stakeholders, including the Swiss government, trial investigators and contractors. At this stage the Company is not modifying guidance with respect to the multiple clinical and preclinical data readouts anticipated this year. AC Immune will keep the market apprised of any new developments or information that may impact clinical timelines.

    Prof. Andrea Pfeifer, CEO of AC Immune SA, concluded: "With the support of our highly respected investors and partners as well as our strong balance sheet, AC Immune is in an excellent position to deliver on these exciting plans and make a significant difference for patients with neurodegenerative diseases."

    Analysis of Financial Statements for the Three Months Ended March 31, 2020

    • Revenues: Revenues for the three months ended March 31, 2020 totaled CHF 12.4 million. This represents a CHF 62.6 million decrease compared to the three months ended March 31, 2019. The decrease predominantly relates to CHF 73.9 million recognized in the prior period associated with our license agreement with Lilly offset by a recognition of the CHF 10 million milestone payment and CHF 2.1 million for research and development activities performed in the current period
    • R&D Expenditures: R&D expenses increased by CHF 3.6 million to CHF 15.2 million for the three months ended March 31, 2020 compared to the prior period. Of this increase, CHF 2.4 million relates to increases in R&D expenses directly allocated to R&D programs such as a CHF 1.3 million increase related to scaling up activities for the Phase 2 clinical trial for ACI-24 in DS and a CHF 1.0 million increase for certain Phase 1 clinical activities completed for our lead MorphomerTM Tau compound. Additionally, personnel costs increased by CHF 0.6 million through the addition of 15 FTEs with remaining increases of CHF 0.6 million in regulatory and quality assurance and other unallocated research and development costs
    • G&A Expenses: For the three months ended March 31, 2020, G&A increased CHF 1.2 million to CHF 4.5 million. Increases were driven by the addition of seven FTEs as well as an increase in administrative and depreciation expenses
    • IFRS (Loss)/Income for the period: The Company recorded a net loss after taxes of CHF 7.7 million for the three months ended March 31, 2020, compared with net income after taxes of CHF 63.6 million for the prior period
    • Cash Position: The Company had a total cash balance of CHF 277.9 million, comprised of CHF 182.9 million in cash and cash equivalents and CHF 95 million in short-term financial assets. This compares to a total cash balance of CHF 288.6 million as of December 31, 2019. This decrease of CHF 10.7 million is principally due to the factors noted above in the income statement which resulted in a CHF 7.7 million net loss for the period and changes in our working capital. Further details are available in our Statements of Cash Flows on the accompanying Form 6-K

    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, Lilly and Janssen Pharmaceuticals.

    For further information, please contact:

    Head of Investor Relations
    Joshua Drumm
    AC Immune
    Phone: +1 917 809 0814
    Email:
    US Media
    Katie Gallagher
    LaVoieHealthScience
    Phone: +1 617 792 3937
    Email:  
       
    Global Head of Communications
    Judith Moore
    AC Immune
    Phone: +41 79 826 63 82
    Email:
    European Investors & Media
    Chris Maggos
    LifeSci Advisors
    Phone: +41 79 367 6254
    Email:

    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.

    Balance Sheets
    (in CHF thousands)

           
      As of March 31,
    2020
      As of March 31,
    2019
    ASSETS      
    Non-current assets      
    Property, plant and equipment  3,761     3,917  
    Right-of-use assets  2,147     2,255  
    Long-term financial assets 304     304  
    Total non-current assets  6,212     6,476  
           
    Current assets      
    Prepaid expenses  3,419     2,788  
    Accrued income  190     1,095  
    Other current receivables  551     304  
    Short-term financial assets  95,000     95,000  
    Cash and cash equivalents  182,860     193,587  
    Total current assets  282,020     292,774  
    Total assets 288,232     299,250  
           
    SHAREHOLDERS' EQUITY AND LIABILITIES      
           
    Shareholders' equity      
    Share capital  1,437     1,437  
    Share premium  346,568     346,526  
    Accumulated losses  (82,404 )   (75,521 )
    Total shareholders' equity 265,601     272,442  
           
    Non-current liabilities      
    Long-term lease liabilities  1,713     1,813  
    Net employee defined benefit liabilities  7,666     7,485  
    Total non-current liabilities  9,379     9,298  
           
    Current liabilities      
    Trade and other payables  760     142  
    Accrued expenses  9,155     11,797  
    Short-term deferred income  2,452     4,477  
    Short-term financing obligation  324     652  
    Short-term lease liabilities 435     442  
    Other short-term liabilities  126      
    Total current liabilities 13,252     17,510  
    Total liabilities  22,631     26,808  
    Total shareholders' equity and liabilities  288,232     299,250  
               

    Statements of Income/(Loss)
    (in CHF thousands except for share and per share data)

       
      For the Three Months
    Ended March 31,
      2020   2019 
    Revenue      
    Contract revenue  12,411     75,042  
    Total revenue  12,411     75,042  
             
    Operating expenses        
    Research & development expenses  (15,209 )   (11,592 )
    General & administrative expenses  (4,504 )   (3,294 )
    Total operating expenses  (19,713 )   (14,886 )
    Operating income/(loss)  (7,302 )   60,156  
             
    Finance expense, net  (393 )   (80 )
    Change in fair value of conversion feature      4,505  
    Interest income  60     89  
    Interest expense  (54 )   (1,096 )
    Finance result, net  (387 )   3,418  
             
    Income/(loss) before tax  (7,689 )   63,574  
    Income tax expense      
    Income/(loss) for the period  (7,689 )   63,574  
             
    Earnings/(loss) per share (EPS):        
               
    Basic income/(loss) for the period attributable to equity holders  (0.11 )   0.94  
               
    Diluted income/(loss) for the period attributable to equity holders  (0.11 )   0.91  
               


    Statements of Comprehensive Income/(Loss) For the Three Months
    Ended March 31,
    (in CHF thousands)  2020     2019  
             
    Income/(loss) for the period  (7,689 )   63,574  
    Other comprehensive income/(loss) not to be reclassified to income or loss in subsequent periods (net of tax):        
    Re-measurement losses on defined benefit plans       
    Total comprehensive income/(loss), net of tax  (7,689 )   63,574  
               

    Reconciliation of Income/(Loss) to Adjusted Income/(Loss) and
    Earnings/(Loss) Per Share to Adjusted Earnings/(Loss) Per Share

       
      For the Three Months
    Ended March 31,
      2020   2019
    (in CHF thousands except for share and per share data)  
    Income/(Loss)  (7,689 )   63,574  
    Adjustments:          
    Non-cash share-based payments (a)  852     584  
    Foreign currency losses (b)  454     45  
    Effective interest expense (c)  54     991  
    Change in fair value of conversion feature (d)      (4,505 )
    Adjusted Income/(Loss)  (6,329 )   60,689  
               
    Earnings/(Loss) per share – basic  (0.11 )   0.94  
    Earnings/(Loss) per share – diluted  (0.11 )   0.91  
    Adjustment to earnings/(loss) per share – basic  0.02     (0.05 )
    Adjustment to earnings/(loss) per share – diluted  0.02     (0.06 )
    Adjusted earnings/(loss) per share – basic  (0.09 )   0.89  
    Adjusted earnings/(loss) per share – diluted  (0.09 )   0.85  
    Weighted-average number of shares outstanding Adjusted earnings/(loss)–basic 71,864,213     67,922,939  
    Weighted-average number of shares outstanding Adjusted earnings/(loss)–diluted  71,882,607     71,276,000  
    1. Reflects non-cash expenses associated with share-based compensation for equity awards issued to Directors, Management and employees of the Company. This expense reflects the awards' fair value recognized for the portion of the equity award which is vesting over the period.

    2. Reflects foreign currency remeasurement gains and losses for the period, predominantly impacted by the change in the exchange rate between the US Dollar and the Swiss Franc.

    3. Effective interest expense for the period relates to the accretion of the Company's convertible loan in accordance with the effective interest method.

    4. Change in fair value of conversion feature that is bifurcated from the convertible loan host debt with Lilly.

    Adjustments for the three months ended March 31, 2020 and March 31, 2019 were CHF 1.3 million in net losses and CHF 2.9 million in net gains, respectively. The Company recorded CHF 0.9 million for the three months, respectively, for share-based compensation expenses. There were foreign currency remeasurement losses of CHF 0.5 million and less than CHF 0.1 million, respectively, predominantly related to the increased foreign currency cash balance of the Company and movement in our forward contract. In Q1 2019, the Company recorded CHF 1.0 million for amortization of effective interest and recognized a CHF 4.5 million gain for the change in fair value of the liability related to the conversion feature. These were not repeated in the current period.

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  28. Seven presentations by AC Immune and its partners at AAT-AD/PD™

    New data on early-stage TDP-43 and alpha-synuclein therapeutic and diagnostic candidates

     A lead anti-alpha-synuclein therapeutic antibody candidate has advanced into preclinical development to treat Parkinson's disease and other synucleinopathies

    LAUSANNE, Switzerland, April 02, 2020 (GLOBE NEWSWIRE) -- AC Immune SA (NASDAQ:ACIU), a Swiss-based, clinical-stage biopharmaceutical company today outlined new preclinical data that will be presented at this year's first ever online AAT-AD/PD™ Focus Meeting from April 2–5, 2020. The presentations describe proof-of-concept preclinical data for lead candidates in AC Immune's therapeutic and diagnostic programs targeting TDP-43 and alpha-synuclein…

    Seven presentations by AC Immune and its partners at AAT-AD/PD™

    New data on early-stage TDP-43 and alpha-synuclein therapeutic and diagnostic candidates

     A lead anti-alpha-synuclein therapeutic antibody candidate has advanced into preclinical development to treat Parkinson's disease and other synucleinopathies

    LAUSANNE, Switzerland, April 02, 2020 (GLOBE NEWSWIRE) -- AC Immune SA (NASDAQ:ACIU), a Swiss-based, clinical-stage biopharmaceutical company today outlined new preclinical data that will be presented at this year's first ever online AAT-AD/PD™ Focus Meeting from April 2–5, 2020. The presentations describe proof-of-concept preclinical data for lead candidates in AC Immune's therapeutic and diagnostic programs targeting TDP-43 and alpha-synuclein. These pathological proteins represent targets of increasing interest for the treatment of neurodegenerative diseases, and AC Immune's programs are amongst the most advanced in the field.

    Prof. Andrea Pfeifer, CEO of AC Immune SA, commented: "Our heritage as a leader in delivering cutting-edge science and our strong cash position provides the foundation to continue advancing data on novel targets for neurodegenerative diseases. The aggregation of pathological forms of TDP-43 and alpha-synuclein proteins are hallmarks of numerous neurodegenerative diseases, including neuroOrphan indications such as frontotemporal lobar degeneration, amyotrophic lateral sclerosis and multiple system atrophy. As novel therapeutic targets in Alzheimer's disease (AD), it has been shown that patients with a high degree of Abeta and Tau pathologies also show a high level of alpha-synuclein and/or TDP-43 co-pathology."

    Prof. Pfeifer continued: "The prevalence of co-pathologies in AD and other neurodegenerative diseases highlights the need for the precision medicine pioneered by AC Immune and the opportunity for earlier and more accurate diagnosis.  As one of the most advanced programs targeting TDP-43, with in vivo proof-of-concept data, we intend to develop our antibody candidate in a neuroOrphan indication. Leading the way in developing the first TDP-43 positron emission tomography (PET) imaging agent, we hope to improve the timing and accuracy of diagnoses in neurodegenerative disease, representing our complementary diagnostics portfolio."

    TDP-43 and alpha-synuclein pathologies have been shown to start from a focal point in the brain and progressively spread to other brain regions with disease progression. Antibody-mediated clearance of pathological TDP-43 and alpha-synuclein represent attractive strategies for therapeutic intervention. Availability of non-invasive tools like PET imaging agents would allow accurate diagnosis and monitoring of disease progression, and would potentially enable longitudinal drug efficacy measurements in patients.

    The three preclinical studies that will be presented at AAT-AD/PD™ illustrate how AC Immune continues to leverage its proprietary technology platforms, SupraAntigen™ and Morphomer™ to develop product candidates against pathologies associated with TDP-43 and alpha-synuclein.

    Anti-TDP-43 antibody

    Data to be presented for the first time, shows that the Company's lead TDP-43 antibody candidate mitigated TDP-43 neuropathology in a mouse model of TDP-43 proteinopathies. The unique pool of TDP-43 antibodies generated by AC Immune's proprietary SupraAntigen™ platform also allowed development of highly sensitive assays for detection and quantification of total and disease-specific TDP-43 isoforms in biofluids with the potential for clinical biomarker evaluation.

    Morphomer™ TDP-43 imaging

    Data for a first in class TDP-43 PET tracer will illustrate how the lead candidate was identified and optimized. The lead candidate, generated using the proprietary Morphomer™ platform, demonstrates binding to brain-derived pathological TDP-43 aggregates with high affinity and, importantly, direct target engagement on patient brain tissue.

    Anti-alpha-synuclein antibody

    Using the SupraAntigen™ platform, antibodies with high-affinity for aggregated alpha-synuclein have been developed which prevent the intercellular spreading of toxic alpha-synuclein species. Data, presented for the first time, demonstrate that lead candidate antibodies reduce the de novo formation of alpha-synuclein aggregates in vitro and significantly decrease spreading of alpha-synuclein pathology in a mouse model of human disease. A lead therapeutic candidate has been advanced into preclinical development to treat Parkinson's disease and other synucleinopathies.

    Prof. Pfeifer added: "AC Immune continues to deliver on its Roadmap to Successful Therapies for Neurodegenerative Diseases, enabling precision medicine by selecting clinical study populations based on the presence of the underlying proteinopathies."

    AAT-AD/PD™ features seven presentations by AC Immune and its partners:

    • Exploratory analysis of biomarker data from Phase 2/3 crenezumab studies using the neurotoolkit assay panel
      Date: April 2, 2020 | 11:40 – 12:00 am CET
      Presenter: Oral presentation Christina Rabe (Roche program)

    • 18F-PI2620 Tau-PET for assessment of heterogeneous neuropathology in corticobasal syndrome
      Date: April 2, 2020 | 12:40 – 1:00 pm CET
      Presenter: Oral presentation by Carla Palleis (Life Molecular Imaging program)

    • Development of ACI-35.030, a second generation anti-phospho tau vaccine, in clinical evaluation for the treatment of Alzheimer's disease
      Date: April 2, 2020 | 6:15 – 6:35 pm CET
      Presenter: Oral presentation by Marija Vukicevic
    • Monoclonal antibody targeting TDP-43 mitigates associated neuropathology in mouse model of TDP-43 proteinopathy
      Date: April 3, 2020 | 3:10 – 3:30 pm CET
      Presenter: Oral presentation Tariq Afroz

    • Discovery and optimization of candidates for molecular imaging of TDP-43 proteinopathies
      Date: April 3, 2020 | 9:29 – 9:35 am CET
      Presenter: Short oral poster presentation by Tariq Afroz

    • 18F-PI-2620 Tau PET is associated with beta-amyloid in MCI or mild-AD dementia subjects from the elenbecestat Mission AD program
      Date: April 3, 2020 | 5:50 – 6:10 pm CET
      Presenter: Oral presentation Andrew Stephens (Life Molecular Imaging program)

    • Targeting spreading of pathological alpha-synuclein to treat Parkinson's disease
      Date: April 5, 2020 | 8:55 – 9:15 am CET
      Presenter: Oral presentation Elpida Tsika

    AC Immune's presentations are available to download from the AAT-AD/PD™ website for those registered to attend the congress.

    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, SupraAntigen™ and Morphomer™, 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, Lilly and Janssen.

    For further information, please contact:

    Head of Investor Relations
    Joshua Drumm
    AC Immune
    Phone: +1 917 809 0814
    Email:

     
    US Media
    Katie Gallagher
    LaVoieHealthScience
    Phone: +1 617 792 3937
    Email:

     
    Global Head of Communications
    Judith Moore
    AC Immune
    Phone: +41 79 826 63 82
    Email:

    European Investors & Media
    Chris Maggos
    LifeSci Advisors
    Phone: +41 79 367 6254
    Email:

    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.

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    • Ongoing strong financial position with CHF 288.6 million in cash, ensuring the Company is fully financed through Q1 2024, excluding potential incoming milestones

    • Received CHF 110 million in upfront and development milestone payments and a USD 50 million equity note in 2019 as a result of the Morphomer™ Tau Lilly partnership

    • Added new potential CHF 60 million Phase 2 initiation milestone and achieved CHF 10 million milestone in Q1 2020 in Lilly partnership

    • Five clinical milestones expected in 2020 including the first Phase 2 readout of an anti-Tau antibody in Alzheimer's disease (AD)

    • Initiated three clinical trials targeting Tau and a substudy within the ongoing Phase 2 Alzheimer's Prevention Initiative trial

    LAUSANNE, Switzerland, March 30…

    • Ongoing strong financial position with CHF 288.6 million in cash, ensuring the Company is fully financed through Q1 2024, excluding potential incoming milestones

    • Received CHF 110 million in upfront and development milestone payments and a USD 50 million equity note in 2019 as a result of the Morphomer™ Tau Lilly partnership

    • Added new potential CHF 60 million Phase 2 initiation milestone and achieved CHF 10 million milestone in Q1 2020 in Lilly partnership

    • Five clinical milestones expected in 2020 including the first Phase 2 readout of an anti-Tau antibody in Alzheimer's disease (AD)

    • Initiated three clinical trials targeting Tau and a substudy within the ongoing Phase 2 Alzheimer's Prevention Initiative trial

    LAUSANNE, Switzerland, March 30, 2020 (GLOBE NEWSWIRE) -- AC Immune SA (NASDAQ:ACIU), a Swiss-based, clinical-stage biopharmaceutical company with a broad pipeline focused on neurodegenerative diseases, today announced financial results for the year ended December 31, 2019, and provided a business and 2020 research and development outlook.

    Prof. Andrea Pfeifer, CEO of AC Immune SA, commented: "AC Immune is building on clinical and business accomplishments in 2019, and anticipates multiple clinical, value-creating milestones in 2020. We anticipate reporting data from two studies of our proprietary anti-Abeta vaccine program, ACI-24 as well as Phase 1 results for the small molecule Morphomer™ Tau aggregation inhibitor, ACI-3024, in partnership with Eli Lilly and Company.

    Prof. Pfeifer continued: "In parallel, our heritage as a leader in delivering cutting-edge science enables our Company to advance novel preclinical therapeutic and diagnostic candidates focused on emerging targets and neuroinflammation towards the clinic, setting the stage for additional value creation and partnership opportunities. AC Immune's leading position in the field is built upon our proprietary discovery technology platforms, SupraAntigen™ and Morphomer™, as well as our personalized medicine approach and exceptional development execution."

    2019 and Q1 2020 Research & Development Highlights
    Successful execution in preclinical and clinical development during 2019 resulted in a stronger pipeline.

    • A Phase 1 study is ongoing for ACI-3024, a first-in-class investigational oral small molecule Morphomer™ Tau specific aggregation inhibitor that will be studied in neurodegenerative diseases characterized by the presence of pathological Tau aggregates. 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; 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 Morphomer™ Tau 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.
    • Initiation of a second Phase 2 trial of semorinemab in patients with moderate AD, by our collaboration partner Genentech, a member of the Roche Group. This antibody is also being studied in a separate Phase 2 trial in prodromal to mild AD
    • Received a milestone payment from our collaboration partner, Life Molecular Imaging, in connection with the initiation of a Phase 2 study in AD of the Tau positron emission tomography (PET) tracer PI-2620
    • Initiation of a Phase 1b/2a clinical trial in early AD to evaluate the anti-phospho-Tau vaccine, ACI-35.030, which targets pathological Tau and is intended as a disease-modifying treatment for AD and other Tauopathies in collaboration with Janssen Pharmaceuticals, Inc
    • Initiation of a substudy by our partner Genentech, a member of the Roche Group, within the ongoing Phase 2 Alzheimer's Prevention Initiative (API) trial of AC Immune's investigational candidate, crenezumab. This substudy aims to measure Tau burden using PET in order to increase the understanding of disease progression in the preclinical stage of autosomal dominantly inherited AD
    • Presented initial interim data from an on-going Phase 1b trial of the ACI-24 anti-Abeta vaccine to treat Down syndrome (DS)-related AD 
    • Discontinuation by our collaboration partner Roche of the CREAD and CREAD 2 Phase 3 studies of the anti-beta-amyloid antibody, crenezumab, in people with prodromal to mild sporadic AD
    • Established a research collaboration with leading scientists at the Perelman School of Medicine, University of Pennsylvania focused on studying the pathological mechanisms of TDP-43 misfolding and aggregation
    • Awarded a new grant from The Michael J. Fox Foundation (MJFF) for development of AC Immune's pioneering alpha-synuclein PET tracers
    • Hosted two Key Opinion Leader (KOL) events focused on "untangling" Tau pathology as an important therapeutic and diagnostic target for AD and other neurodegenerative diseases, and on treating DS-related AD

    2020 Research & Development Outlook
    The coming years will be transformational for the field of neuroscience and AC Immune is poised to make significant clinical contributions, capturing substantial interest and value in 2020 and beyond.  The Company will deliver multiple near-term catalysts, including results from five clinical trials. The Company's sustained growth is driven by its industry-leading Roadmap to Successful Therapies for Neurodegenerative Diseases, and is fueled by its proprietary technology platforms, SupraAntigen™ and Morphomer™, which continue to generate therapeutic antibody, small molecule and vaccine candidates.

    2020 Clinical Readouts

    • Semorinemab, anti-Tau antibody: Phase 2 trial primary completion (estimated last patient, last visit) in prodromal/mild in Q2
    • ACI-24 anti-Abeta vaccine in DS: Phase 1b full study reporting in H2
    • ACI-35.030 anti-pTau vaccine: Phase 1b/2a in AD interim analysis in Q2
    • ACI-3024 small molecule Morphomer™ Tau aggregation inhibitor: Phase 1 results in healthy volunteers in Q2; data disclosed by partner in H2 (expected)
    • ACI-24 in AD: Phase 2, 12-month interim analysis in H2

    2020 Preclinical Milestones

    • Alpha-synuclein antibody: started investigational new drug (IND)-enabling studies for lead candidate in Q1
    • Anti-TDP-43 antibody: declare clinical lead and start IND-enabling studies in Q2
    • Alpha-synuclein small molecule: identify first biologically active small molecule in Q2
    • Alpha-synuclein imaging agent: advance third generation candidate to clinical stage in Q4
    • Neuroinflammation: declare lead candidates for small molecule and antibody programs in Q4

    Prof. Pfeifer concluded: "In summary, 2020 begins a decade with the potential for major neuroscience advances. With AC Immune's remarkably broad development pipeline focused on neurodegenerative diseases we have multiple opportunities to contribute to the advancement of this field from a business, clinical and human perspective."

    Analysis of Financial Statements for the year ended December 31, 2019

    • Cash Position: The Company had a total cash balance of CHF 288.6 million, comprised of CHF 193.6 million in cash and cash equivalents and CHF 95 million in short-term financial assets. This compares to a total cash balance of CHF 186.5 million as of December 31, 2018. The increase of CHF 102.1 million is principally due to the CHF 80 million upfront payment, USD 50 million convertible equity note and CHF 30 million milestone payment related to the agreement with Lilly. The total shareholders' equity position increased to CHF 272.4 million from CHF 177.6 million as of the prior year. The Company's cash balance provides enough capital resources to progress through at least Q1 2024
    • Revenues: Revenues for the year ended December 31, 2019 totaled CHF 111.0 million. This represents an increase of CHF 103.8 million compared to 2018. The increase for the year end relates to the recognition of CHF 75.7 million from the right-of-use license and research and development activities linked to the 2018 Lilly agreement and a CHF 30 million payment for the first milestone achieved with Lilly. Additionally, the Company recorded a EUR 2 million (CHF 2.2 million) in connection with the initiation of a Phase 2 trial in AD of Tau PET Tracer with Life Molecular Imaging
    • R&D Expenditures: R&D expenses increased by CHF 6.2 million to CHF 50.4 million for the year ended December 31, 2019. Of this increase, CHF 1.7 million relates to increases in R&D expenses directly allocated to R&D programs such as a CHF 0.9 million increase related to higher research, preclinical and manufacturing costs for the lead alpha-synuclein antibody and a CHF 0.7 million increase for manufacturing and preparation of the Phase 2 study for ACI-24 for DS. Additionally, the personnel costs increased by CHF 1.6 million through the addition of 16 FTEs with remaining increases of CHF 2.8 million in the area of consumables, depreciation of R&D equipment and regulatory and quality assurance
    • G&A Expenses: For the year ended December 31, 2019, G&A increased CHF 3.6 million to CHF 16.1 million. Increases were driven by personnel and IT expenses
    • IFRS Income/(Loss) for the period: The Company recorded net income after taxes of CHF 45.4 million for the year ended December 31, 2019, compared with net losses of CHF 50.9 million for 2018

    2020 Financial Guidance
    For the full year 2020, the Company expects its total cash burn to range between CHF 65‒80 million at constant exchange rates.

    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, SupraAntigen™ and Morphomer™, 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, Lilly and Janssen.

    For further information, please contact:

    Head of Investor Relations
    Joshua Drumm
    AC Immune
    Phone: +1 917 809 0814
    Email:

     
    US Media
    Katie Gallagher
    LaVoieHealthScience
    Phone: +1 617 792 3937
    Email:

     
    Global Head of Communications
    Judith Moore
    AC Immune
    Phone: +41 79 826 63 82
    Email:

    European Investors & Media
    Chris Maggos
    LifeSci Advisors
    Phone: +41 79 367 6254
    Email:
     

    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.


    Balance Sheets
    (in CHF thousands)

      As of
    December 31,
    2019
      As of
    December 31,

    2018
         
         
    ASSETS    
         
    Non-current assets    
    Property, plant and equipment 3,917     3,324  
    Right-of-use assets 2,255      
    Long-term financial assets 304     304  
    Total non-current assets 6,476     3,628  
         
         
    Current assets    
    Prepaid expenses 2,788     2,364  
    Accrued income 1,095     3,667  
    Finance receivable     199  
    Other current receivables 304     236  
    Short-term financial assets 95,000     30,000  
    Cash and cash equivalents 193,587     156,462  
    Total current assets 292,774     192,928  
    Total assets 299,250     196,556  
         
         
    SHAREHOLDERS' EQUITY AND LIABILITIES    
         
    Shareholders' equity    
    Share capital 1,437     1,351  
    Share premium 346,526     298,149  
    Accumulated losses (75,521 )   (121,877 )
    Total shareholders' equity 272,442     177,623  
         
         
    Non-current liabilities    
    Long-term financing obligation     186  
    Long-term lease liabilities 1,813      
    Net employee defined benefit liabilities 7,485     5,665  
    Total non-current liabilities 9,298     5,851  
         
         
    Current liabilities    
    Trade and other payables 142     1,979  
    Accrued expenses 11,797     10,420  
    Short-term deferred income 4,477     351  
    Short-term financing obligation 652     332  
    Short-term lease liabilities 442      
    Total current liabilities 17,510     13,082  
    Total liabilities 26,808     18,933  
    Total shareholders' equity and liabilities 299,250     196,556  
               

    Statements of Income/(Loss)
    (in CHF thousands except for per share data)

      For the years ended
    December 31,
      2019    2018    2017 
       
       
    Revenue      
    Contract revenue 111,026     7,194     20,255  
    Total revenue 111,026     7,194     20,255  
           
           
    Operating expenses      
    Research & development expenses (50,432 )   (44,277 )   (32,663 )
    General & administrative expenses (16,058 )   (12,467 )   (10,131 )
    Total operating expenses (66,490 )   (56,774 )   (42,794 )
    Operating income/(loss) 44,536     (49,550 )   (22,539 )
           
    Finance income / (expense), net (2,046 )   (1,132 )   (4,055 )
    Change in fair value of conversion feature 4,542          
    Interest income 304     29     330  
    Interest expense (1,894 )   (298 )   (147 )
    Finance result, net 906     (1,401 )   (3,872 )
    Income/(loss) before tax 45,442     (50,951 )   (26,411 )
    Income tax expense          
    Income/(loss) for the period 45,442     (50,951 )   (26,411 )
           
           
    Income/(loss) per share (EPS):      
    Basic income/(loss) for the period attributable to equity holders 0.64     (0.82 )   (0.46 )
    Diluted income/(loss) for the period attributable to equity holders 0.64     (0.82 )   (0.46 )
                     

    Statements of Comprehensive Income/(Loss)
    (in CHF thousands)

      For the years ended
    December 31,
      2019    2018    2017 
       
       
    Income/(loss) for the period 45,442     (50,951 )   (26,411 )
    Other comprehensive income/(loss) not to be reclassified to income or loss in subsequent periods (net of tax):      
    Re-measurement losses on defined benefit plans (net of tax) (1,304 )   (302 )   (780 )
    Total comprehensive income/(loss), net of tax 44,138     (51,253 )   (27,191 )
                     


    Reconciliation of Income/(Loss) to Adjusted Income/(Loss) and
    Earnings/(Loss) Per Share to Adjusted Earnings/(Loss) Per Share

      For the Years Ended
    December 31,
    (in CHF thousands except for share and per share data) 2019    2018    2017 
    Income/(Loss)