1. 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.

     



    Primary Logo

    View Full Article Hide Full Article
  2. 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.



    Primary Logo

    View Full Article Hide Full Article
  3. 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.



    Primary Logo

    View Full Article Hide Full Article
    • 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.

    Primary Logo

    View Full Article Hide Full Article
  4. 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.

    Primary Logo

    View Full Article Hide Full Article
  5. 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.

    Primary Logo

    View Full Article Hide Full Article
  6. 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.

    Primary Logo

    View Full Article Hide Full Article
  7. 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.

    Primary Logo

    View Full Article Hide Full Article
  8. 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

     

    Primary Logo

    View Full Article Hide Full Article
  9. 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.

    Primary Logo

    View Full Article Hide Full Article
    • 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.

    Primary Logo

    View Full Article Hide Full Article
  10. 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.

    Primary Logo

    View Full Article Hide Full Article
  11. 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.

    Primary Logo

    View Full Article Hide Full Article
  12. 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.

    Primary Logo

    View Full Article Hide Full Article
  13. 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.

    Primary Logo

    View Full Article Hide Full Article
  14. 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.

    Primary Logo

    View Full Article Hide Full Article
  15. 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.

    Primary Logo

    View Full Article Hide Full Article
  16. 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.

    Primary Logo

    View Full Article Hide Full Article
  17. 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.

     

    Primary Logo

    View Full Article Hide Full Article
    • 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.

    Primary Logo

    View Full Article Hide Full Article
  18. 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.

    Primary Logo

    View Full Article Hide Full Article
    • 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) 45,442     (50,951 )   (26,411 )
           
    Adjustments:      
    Non-cash share-based payments (a) 2,834     2,518     1,579  
    Foreign currency (gains)/losses (b) 826     1,179     4,168  
    Effective interest expense (c) 1,355          
    Change in fair value of conversion feature (d) (4,542 )        
    Adjusted Income/(Loss) 45,915     (47,254 )   (20,664 )
                     
    Earnings/(Loss) per share – basic 0.64     (0.82 )   (0.46 )
    Earnings/(Loss) per share – diluted 0.64     (0.82 )   (0.46 )
    Adjustment to earnings/(loss) per share – basic 0.01     0.06     0.10  
    Adjustment to earnings/(loss) per share – diluted 0.00     0.06     0.10  
    Adjusted earnings/(loss) per share – basic 0.65     (0.76 )   (0.36 )
    Adjusted earnings/(loss) per share – diluted 0.64     (0.76 )   (0.36 )
    Weighted-average number of shares used to compute Adjusted Loss per share – basic 70,603,611     61,838,228     57,084,295  
    Weighted-average number of shares used to compute Adjusted Loss per share – diluted 71,103,341     61,838,228     57,084,295  
    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 years ended December 31, 2019, 2018 and 2017, were CHF 0.4 million in net gains, CHF 3.7 million in net losses and CHF 5.7 million in net losses, respectively. The Company recorded CHF 2.8 million, CHF 2.5 million and CHF 1.6 million for the years ended December 31, 2019, 2018 and 2017, respectively, for share-based compensation expenses. There were foreign currency remeasurement losses of CHF 0.8 million, CHF 1.2 million, CHF 4.2 million for the years ended December 31, 2019, 2018 and 2017, 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 and gains in 2018 nor 2017, respectively.

    Primary Logo

    View Full Article Hide Full Article
    • CHF 10 million milestone recognizes development progress
    • Updated financial terms add a new CHF 60 million milestone for Phase 2 initiation
    • Total potential deal value is now CHF 1.86 billion, up from CHF 1.82 billion

    LAUSANNE, Switzerland, March 23, 2020 (GLOBE NEWSWIRE) -- AC Immune SA (NASDAQ:ACIU), a Swiss-based, clinical-stage biopharmaceutical company, today announced that it will receive a second milestone payment of CHF 10 million from Eli Lilly and Company on or before March 31, 2020 related to development progress in the small molecule Morphomer™ Tau  aggregation inhibitor program.

    The multi-year collaboration agreement between Lilly and AC Immune was originally announced in December 2018 and focuses on the broad development of Morphomer™…

    • CHF 10 million milestone recognizes development progress
    • Updated financial terms add a new CHF 60 million milestone for Phase 2 initiation
    • Total potential deal value is now CHF 1.86 billion, up from CHF 1.82 billion

    LAUSANNE, Switzerland, March 23, 2020 (GLOBE NEWSWIRE) -- AC Immune SA (NASDAQ:ACIU), a Swiss-based, clinical-stage biopharmaceutical company, today announced that it will receive a second milestone payment of CHF 10 million from Eli Lilly and Company on or before March 31, 2020 related to development progress in the small molecule Morphomer™ Tau  aggregation inhibitor program.

    The multi-year collaboration agreement between Lilly and AC Immune was originally announced in December 2018 and focuses on the broad development of Morphomer™ Tau aggregation inhibitors for Alzheimer's disease (AD) and other neurodegenerative diseases.

    The second milestone payment of CHF 10 million marks significant progress between the companies in just 15 months. In that time, ACI-3024, a first-in-class investigational oral small molecule Tau Morphomer™ for treatment of Alzheimer's disease (AD) and other neurodegenerative disorders, has advanced from preclinical into Phase 1 clinical development. Lilly made a first milestone payment of CHF 30 million in September 2019.

    Under the updated collaboration terms, AC Immune will now also be eligible for a new CHF 60 million potential milestone after initiation of Tau Morphomer™ Phase 2 clinical testing. No additional changes were made to other later-stage milestones or royalty terms.

    Prof. Andrea Pfeifer, CEO of AC Immune SA, commented: "This new Phase 2 milestone was not included previously in the agreement and its addition increases the total deal value and offers a new significant potential source of medium-term non-dilutive financing. This reflects the progress achieved in this transformative partnership with Lilly, who is an industry leader in Alzheimer's research, and our confidence in the partnership's potential to make a major contribution to treating this devastating disease and to create shareholder value."

    Tau is a high priority therapeutic target in the complex treatment paradigm for AD and ACI-3024 is the most advanced orally available small molecule therapeutic candidate of its kind in development. ACI-3024's proposed unique mechanism of action targets both intracellular and extracellular Tau aggregates, potentially slowing or stopping the accumulation and propagation of pathological Tau aggregates in AD patients. Compared to other Tau-targeting molecules in development, the key potential differentiating factor is that ACI-3024 has been shown to act intracellularly to address specifically Tau pathology at an early stage.

    ACI-3024 is the lead molecule, discovered by AC Immune and being developed within the license and collaboration agreement between AC Immune and Lilly to research and develop small molecule Tau Morphomer™ aggregation inhibitors for the treatment of AD and other neurodegenerative diseases. The collaboration combines AC Immune's proprietary Morphomer™ discovery platform technology and early development experience with Lilly's established clinical development expertise and commercial capabilities in central nervous system disorders. Under the agreement AC Immune is conducting the initial Phase 1 development of ACI-3024 while Lilly will fund and conduct further clinical development.

    The Phase 1 trial initiated in July 2019 is a randomized, placebo-controlled, double-blind, sequential single and multiple ascending dose study that aims to assess the safety, tolerability, pharmacokinetics, and pharmacodynamics of ACI-3024 in healthy volunteers. Data from the study may be communicated as soon as the second half of 2020, at the discretion of Lilly.

    About the AC Immune and Eli Lilly and Company Agreement

    Under the terms of the agreement, initially signed in December 2018, Lilly received worldwide commercialization rights for Tau aggregation inhibitors for Alzheimer's disease and other neurodegenerative diseases.  AC Immune received an upfront payment of CHF 80 million as well as $50 million in exchange for a note, convertible to equity at a premium. AC Immune is now eligible to receive other development, regulatory and commercial milestones, up to approximately CHF 1.8 billion, and tiered royalty payments in the low double digits. The initial CHF 60 million milestone payment has been modified such that Lilly has paid AC Immune CHF 30 million during Q3 2019 and CHF 10 million in Q1 2020, instead of CHF 30 million; and, AC Immune now is eligible for a new additional milestone payment of CHF 60 million within 60 days after dosing of the first patient in the first Phase 2 clinical trial of a Tau Morphomer™ in the United States or European Union. The amendment to the financial terms increases the total deal value by CHF 40 million to CHF 1.86 billion, up from CHF 1.82 billion.

    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 Lilly, Roche/Genentech, and Janssen Pharmaceuticals.

    For further information, please contact:

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

    Primary Logo

    View Full Article Hide Full Article
  19. LAUSANNE, Switzerland, March 05, 2020 (GLOBE NEWSWIRE) -- AC Immune SA (NASDAQ:ACIU), a Swiss-based, clinical-stage biopharmaceutical company, announced today that four new data presentations will be delivered at this year's AAT-AD/PD™ Focus Meeting, taking place April 2‒5 in Vienna, from the Company's broad neurodegenerative disease pipeline.

    The four presentations will focus on advances in wholly-owned as well as partnered product programs. One presentation will showcase nonclinical data involved in the development of the anti-phospho Tau (anti-pTau) vaccine, ACI-35.030, currently in Phase 2 clinical testing. Two presentations will highlight our work to target TDP-43 proteinopathies including the mitigation of associated neuropathology using…

    LAUSANNE, Switzerland, March 05, 2020 (GLOBE NEWSWIRE) -- AC Immune SA (NASDAQ:ACIU), a Swiss-based, clinical-stage biopharmaceutical company, announced today that four new data presentations will be delivered at this year's AAT-AD/PD™ Focus Meeting, taking place April 2‒5 in Vienna, from the Company's broad neurodegenerative disease pipeline.

    The four presentations will focus on advances in wholly-owned as well as partnered product programs. One presentation will showcase nonclinical data involved in the development of the anti-phospho Tau (anti-pTau) vaccine, ACI-35.030, currently in Phase 2 clinical testing. Two presentations will highlight our work to target TDP-43 proteinopathies including the mitigation of associated neuropathology using our therapeutic antibody candidate in an animal model of human disease and our efforts to develop the first in class candidate for molecular imaging of TDP-43 in humans. The final presentation will describe the discovery and characterization of an antibody that targets the spreading of alpha-synuclein in vitro and in vivo.

    Prof. Andrea Pfeifer, CEO of AC Immune SA, commented: "We are very much looking forward to demonstrating the depth of the AC Immune product pipeline to the scientific community at the upcoming AAT-AD/PD™ Focus Meeting. Following our Roadmap to Successful Therapies for Neurodegenerative Diseases, the programs highlighted demonstrate the strong progress we are making in our clinical development and early-stage research based on our proprietary SupraAntigen™ and Morphomer™ discovery platforms. It is clear Alzheimer's disease has a high level of proteinopathies and co-pathologies involving alpha-synuclein or TDP-43, which could play important roles in neurodegenerative diseases, and as such are an important part of our research efforts."

    Scientific updates at the AAT-AD/PD™ Focus Meeting 2020, Vienna, Austria, April 2‒5, 2020

    ACI-35.030 anti-pTau vaccine

    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
    Location: Hall E
    Presenter: Oral presentation by Marija Vukicevic

    Morphomer™ TDP-43 imaging

    Discovery and optimization of candidates for molecular imaging of TDP-43 proteinopathies
    Date: April 3, 2020 | 9:41 – 9:47 am CET
    Location: Hall M
    Presenter: Short oral poster presentation by Tariq Afroz

    Anti-TDP-43 antibody

    Monoclonal antibody targeting TDP-43 mitigates associated neuropathology in mouse model of TDP-43 proteinopathy
    Date: April 3, 2020 | 3:30 – 3:50 pm CET
    Location: Hall F1
    Presenter: Oral presentation by Tariq Afroz

    Anti-alpha-synuclein antibody

    Targeting spreading of pathological alpha-synuclein to treat Parkinson's disease            

    Date: April 5, 2020 | 9:15 – 9:35 am CET
    Location: Hall M
    Presenter: Oral presentation by Elpida Tsika

    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, Eli Lilly and Company 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. 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.

    Primary Logo

    View Full Article Hide Full Article
  20. LAUSANNE, Switzerland, Nov. 14, 2019 (GLOBE NEWSWIRE) -- AC Immune SA (NASDAQ:ACIU), a Swiss-based biopharmaceutical company with a broad clinical-stage pipeline focused on neurodegenerative diseases, today announced that it will present at Jefferies 2019 London Healthcare Conference in London, UK, taking place November 20 – 21, 2019.

    Prof. Andrea Pfeifer, Ph.D., CEO of AC Immune SA, will discuss the Company's world-leading pipeline and Roadmap to Successful Therapies for Neurodegenerative Diseases, with a focus on its clinical programs targeting misfolded Tau protein. AC Immune is addressing the full spectrum of Tau pathology by detecting and inhibiting both early seeding and extracellular spreading of Tau with its internally discovered…

    LAUSANNE, Switzerland, Nov. 14, 2019 (GLOBE NEWSWIRE) -- AC Immune SA (NASDAQ:ACIU), a Swiss-based biopharmaceutical company with a broad clinical-stage pipeline focused on neurodegenerative diseases, today announced that it will present at Jefferies 2019 London Healthcare Conference in London, UK, taking place November 20 – 21, 2019.

    Prof. Andrea Pfeifer, Ph.D., CEO of AC Immune SA, will discuss the Company's world-leading pipeline and Roadmap to Successful Therapies for Neurodegenerative Diseases, with a focus on its clinical programs targeting misfolded Tau protein. AC Immune is addressing the full spectrum of Tau pathology by detecting and inhibiting both early seeding and extracellular spreading of Tau with its internally discovered, best-in-class small molecule (Partner: Eli Lilly), antibody (Partner: Roche/Genentech) and vaccine (Partner: Janssen) therapies, as well as its highly specific Tau diagnostic agents (Partner: Life Molecular Imaging).

    Jefferies 2018 London Healthcare Conference
    Date: November 21, 2019 | 5:20 pm GMT
    Format: Fireside chat
    Presenter: Prof. Andrea Pfeifer, CEO, AC Immune

    A webcast of the presentation will be available on the Events Page of AC Immune's website and at the Jefferies 2018 Healthcare Conference website and will be active for 90 days following the event.

    About AC Immune
    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, Lilly and Janssen Pharmaceuticals Inc.

    As a strategic leader in the field of neurodegenerative diseases, AC Immune has developed a five point Roadmap to Successful Therapies for Neurodegenerative Diseases that recognizes the importance of treating earlier, targeting Tau, focusing on more homogeneous populations, precision medicine and exploring neuroinflammation as a target.

    For further information, please contact:

    Head of Investor Relations
    Joshua Drumm, Ph.D.
    AC Immune
    Phone: +1 646 876 5538
    E-mail:
    U.S. Media
    Katie Gallagher
    LaVoieHealthScience
    Phone: +1 617 792 3937
    E-mail:
     

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

    European Investors
    Chris Maggos
    LifeSci Advisors
    Phone: +41 79 367 6254
    E-mail:

    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.

    Primary Logo

    View Full Article Hide Full Article
  21.  CHF 32 Million in Milestone Revenues

    Multiple Upcoming Catalysts

    Execution Across Clinical and Preclinical Neurodegenerative Development Pipeline

    LAUSANNE, Switzerland, Nov. 13, 2019 (GLOBE NEWSWIRE) -- AC Immune SA (NASDAQ:ACIU), a Swiss-based biopharmaceutical company with a broad clinical-stage pipeline focused on neurodegenerative diseases, today provided a business and clinical update and reported its consolidated financial results for the third quarter of 2019.

    Prof. Andrea Pfeifer, Ph.D., CEO of AC Immune, commented: "AC Immune, together with our leading pharmaceutical partners, is advancing one of the industry's broadest, most diversified development pipelines targeting neurodegenerative diseases. This quarter, we continued to demonstrate…

     CHF 32 Million in Milestone Revenues

    Multiple Upcoming Catalysts

    Execution Across Clinical and Preclinical Neurodegenerative Development Pipeline

    LAUSANNE, Switzerland, Nov. 13, 2019 (GLOBE NEWSWIRE) -- AC Immune SA (NASDAQ:ACIU), a Swiss-based biopharmaceutical company with a broad clinical-stage pipeline focused on neurodegenerative diseases, today provided a business and clinical update and reported its consolidated financial results for the third quarter of 2019.

    Prof. Andrea Pfeifer, Ph.D., CEO of AC Immune, commented: "AC Immune, together with our leading pharmaceutical partners, is advancing one of the industry's broadest, most diversified development pipelines targeting neurodegenerative diseases. This quarter, we continued to demonstrate strong progress across our pipeline of potentially best-in-class small molecule, antibody, and vaccine therapeutics, as well as our cutting-edge diagnostic agents. This resulted in milestones achieved totaling CHF 32 million which were comprised of CHF 30 million from Eli Lilly and Company and EUR 2 million (CHF 2.2 million) from Life Molecular Imaging."

    Prof. Pfeifer continued, "We anticipate multiple catalysts in 2019 and 2020, highlighted by expected Phase 2 data for semorinemab, our anti-Tau antibody partnered with Genentech/Roche, which we anticipate will be the first Phase 2 data available for a Tau-targeted therapy in Alzheimer's disease (AD). We also anticipate achieving further progress across our development pipeline with both early and late stage data readouts that we believe will build substantial value for the Company."

    AC Immune's unique, multi-pronged approach is designed to address the full spectrum of neurodegenerative diseases. By selectively targeting misfolded pathological proteins both intracellularly and extracellularly, and by creating state-of-the-art diagnostic imaging agents that enable early detection of multiple disease pathologies and tracking of disease progression, AC Immune is pioneering a personalized medicine approach to deliver the right therapy to the right patient at the right time.

    Research & Development Highlights

    • Earned a EUR 2 million (CHF 2.2 million) milestone following initiation of longitudinal Phase 2 clinical development of next-generation Tau positron emission tomography (PET) tracer PI-2620 by partner Life Molecular Imaging
    • Received first CHF 30 million milestone payment from Lilly based on achievement of preclinical milestones related to the oral small molecule Tau Morphomer™ program, which is currently advancing in a Phase 1 clinical study. A second CHF 30 million milestone payment is scheduled for Q1 2020, linked to achievement of further development milestones
    • Vaccinated the first patient in a Phase 1b/2a study of anti-phospho-Tau (anti-pTau) vaccine candidate ACI-35.030 in collaboration with Janssen Pharmaceuticals. ACI-35.030 is intended as a disease-modifying treatment for AD and other Tauopathies
    • Recently hosted a key opinion leader (KOL) event focused on the therapeutic and diagnostic potential of targeting Tau pathology, which highlighted AC Immune's differentiated Tau pipeline candidates and key  updates  from the ACI-3024 Tau Morphomer™ small molecule  and ACI-35.030 programs
    • Awarded a new grant from The Michael J. Fox Foundation for the Company's pioneering alpha-synuclein (a-syn) PET tracer program. If successful, AC Immune's program could deliver the world's first imaging agent capable of accurately detecting and monitoring progression of Parkinson's disease

    Analysis of Financial Statements for the Three and Nine Months Ended September 30, 2019

    • Cash Position: The Company had a total cash balance of CHF 302.5 million, comprised of CHF 212.5 million in cash and cash equivalents and CHF 90.0 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 116 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 from December 31, 2018 to CHF 292.4 million from CHF 177.6 million. Further details are available in our corresponding Financial Statements filed on the accompanying Form 6-K
       
    • Revenues: Revenues for the three and nine months ended September 30, 2019 totaled CHF 33.4 million and CHF 110 million, respectively. This represents an increase of CHF 31.1 million and CHF 104.2 million compared to the respective periods in 2018. The increase for the three-month period relates to the recognition of CHF 30.0 million for the first installment of the first milestone achieved with Lilly and EUR 2 million (CHF 2.2 million) in connection with the initiation of a Phase 2 Trial of Tau PET Tracer with Life Molecular Imaging. The increase for the nine-month period is driven by the recognition of CHF 74.6 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 installment of the first milestone achieved with Lilly
       
    • R&D Expenditures: R&D expenditures decreased by CHF 0.1 million (-0.6%) and increased CHF 3.6 million (+11%) for the three and nine months ended September 30, 2019 compared to the comparable periods in 2018, respectively. The increase in R&D expenditures in 2019 was largely due to increased investments in non-AD and new discovery programs. For non-AD, the Company increased investment in its Morphomer™ alpha-synuclein programs and continued to advance the clinical development of its anti-Abeta vaccine ACI-24 in Down Syndrome (DS). In new discovery, the Company continued to focus on its neuroinflammation discovery programs while also increasing investment in its anti-a-synuclein antibody. For AD, the Company's expenditures for the anti-pTau vaccine program decreased due to the completion of certain toxicology and manufacturing work in the prior year as well as a decrease for ACI-24 related to higher costs for the initiation of the Phase 2 study in the prior period
       
    • G&A Expenses: For the three and nine months ended September 30, 2019, G&A increased CHF 1.0 million (+35%) and CHF 2.1 million (+24%) to CHF 4.0 million and CHF 10.8 million, respectively. Increases are driven by rental, personnel and IT expenses
       
    • IFRS Income/(Loss) for the period: The Company recorded net income after taxes of CHF 18.2 million and CHF 64.9 million for the three and nine months ended September 30, 2019, respectively, compared with net losses of CHF 13.5 million and CHF 36.3 million for the comparable periods in 2018

    About AC Immune
    AC Immune SA is a Nasdaq-listed clinical-stage biopharmaceutical company, which aims to become a global leader in Precision Medicine for neurodegenerative diseases. The Company is utilizing two proprietary discovery platforms, SupraAntigenTM and MorphomerTM, to design, discover and develop small molecule and biological therapeutics as well as diagnostic products intended to diagnose, prevent and modify neurodegenerative diseases caused by misfolding proteins. The Company's pipeline features nine therapeutic and three diagnostic product candidates, with five currently in clinical trials. It has collaborations with major pharmaceutical companies including Roche/Genentech, Lilly and Janssen Pharmaceuticals Inc.

    As a strategic leader in the field of neurodegenerative diseases, AC Immune has developed a five-point Roadmap to Successful Therapies for Neurodegenerative Diseases that recognizes the importance of treating earlier, targeting Tau, focusing on more homogeneous patient populations, precision medicine and exploring neuroinflammation as a target.

    For further information, please contact:

    U.S. Investors U.S. Media
    Joshua Drumm, Ph.D. Katie Gallagher 
    AC Immune Investor Relations LaVoieHealthScience
    Phone: +1 646 876 5538 Phone: +1 617 792 3937
    E-mail: E-mail:  
       
    Head of Global Communication European Investors 
    Judith Moore Chris Maggos
    AC Immune LifeSci Advisors
    Phone: +41 79 826 63 82 Phone: +41 79 367 6254 
    Email: E-mail:

    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

      As of
    September 30,
    2019
      As of
    December 31,

    2018
     
    in CHF thousands        
    ASSETS        
             
    Non-current assets        
    Property, plant and equipment 3,702   3,324  
    Right-of-use assets 1,893   -  
    Long-term financial assets 304   304  
    Total non-current assets 5,899   3,628  
             
    Current assets        
    Prepaid expenses 2,997   2,364  
    Accrued income 939   3,667  
    Finance receivable 100   199  
    Other current receivables 2,957   236  
    Short-term financial assets 90,000   30,000  
    Cash and cash equivalents 212,457   156,462  
    Total current assets 309,450   192,928  
    Total assets 315,349   196,556  
             
    SHAREHOLDERS' EQUITY AND LIABILITIES        
             
    Shareholders' equity        
    Share capital 1,436   1,351  
    Share premium 346,479   298,149  
    Accumulated losses (55,532)   (121,877)  
    Total shareholders' equity 292,383   177,623  
             
    Non-current liabilities        
    Long-term financing obligation 297   186  
    Long-term lease liabilities 1,467   -  
    Long-term deferred income 1,092   -  
    Net employee defined benefit liabilities 6,098   5,665  
    Total non-current liabilities 8,954   5,851  
             
    Current liabilities        
    Trade and other payables -   1,979  
    Accrued expenses 8,551   10,420  
    Short-term deferred income 4,701   351  
    Short-term debt obligation 334   332  
    Short-term lease liabilities 426   -  
    Total current liabilities 14,012   13,082  
    Total liabilities 22,966   18,933  
    Total shareholders' equity and liabilities 315,349   196,556  
             
             

    Statements of Income/(Loss)

      For the Three Months
    Ended September 30,
      For the Nine Months
    Ended September 30,
     
      2019   2018   2019   2018  
         
      (in CHF thousands except for per share data)
     
    Revenue                
    Contract revenue 33,411   2,305   109,964   5,791  
    Total revenue. 33,411   2,305   109,964   5,791  
                     
    Operating expenses                
    Research & development expenses (11,478)   (11,546)   (35,770)   (32,150)  
    General & administrative expenses (3,956)   (2,930)   (10,835)   (8,703)  
    Total operating expenses (15,434)   (14,476)   (46,605)   (40,853)  
    Operating income/(loss) 17,977   (12,171)   63,359   (35,062)  
                     
    Finance income / (expense), net 249   (1,314)   (1,564)   (1,149)  
    Change in fair value of conversion feature     4,542    
    Interest income 73     237   3  
    Interest expense (86)   (31)   (1,686)   (66)  
    Finance result, net 236   (1,345)   1,529   (1,212)  
    Income/(loss) before tax 18,213   (13,516)   64,888   (36,274)  
    Income tax expense        
    Income/(loss) for the period 18,213   (13,516)   64,888   (36,274)  
                     
    Income/(loss) per share (EPS):                
    Basic income/(loss) for the period attributable to equity holders 0.25   (0.21)   0.92   (0.61)  
    Diluted income/(loss) for the period attributable to equity holders 0.25   (0.21)   0.92   (0.61)  

    Statements of Comprehensive Income/(Loss)

      For the Three Months
    Ended September 30,
      For the Nine Months
    Ended September 30,
     
      2019   2018   2019   2018  
         
      (in CHF thousands)
     
    Income/(loss) for the period 18,213   (13,516)   64,888   (36,274)  
    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 18,213   (13,516)   64,888   (36,274)  


    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,
     
      2019   2018   2019   2018  
         
      (in CHF thousands except for share and per share data)
     
    Income/(Loss) 18,213   (13,516)   64,888   (36,274)  
    Adjustments:                
    Non-cash share-based payments (a) 882   583   2,027   1,897  
    Foreign currency (gains)/losses (b) (272)   1,296   286   1,101  
    Effective interest expense (c)     1,355    
    Change in fair value of conversion feature (d)     (4,542)    
    Adjusted Income/(Loss) 18,823   (11,637)   64,014   (33,276)  
                     
    Earnings/(Loss) per share – basic 0.25   (0.21)   0.92   (0.61)  
    Earnings/(Loss) per share – diluted 0.25   (0.21)   0.92   (0.61)  
    Adjustment to earnings/(loss) per share – basic 0.01   0.03   (0.02)   0.05  
    Adjustment to earnings/(loss) per share – diluted 0.01   0.03   (0.01)   0.05  
    Adjusted earnings/(loss) per share – basic 0.26   (0.18)   0.91   (0.56)  
    Adjusted earnings/(loss) per share – diluted 0.26   (0.18)   0.91   (0.56)  
    Weighted-average number of shares used to compute Adjusted earnings/(loss) per share – basic 71,822,884   64,862,822   70,184,257   59,912,283  
    Weighted-average number of shares used to compute Adjusted earnings/(loss) per share – diluted. 72,281,264   64,862,822   70,700,690   59,912,283  

    (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.

    For the three and nine months ended September 30, 2019, adjustments increased net income and decreased net income by CHF 0.6 million and CHF 0.9 million compared with decreases to the net losses by CHF 1.9 million and CHF 3.0 million for the comparable periods in 2018, respectively. The Company recorded CHF 0.9 million and CHF 2.0 million for the three and nine months, respectively, for share-based compensation expenses. There were foreign currency remeasurement gains of CHF 0.3 million and remeasurement losses of CHF 0.3 million, respectively, related to foreign currency fluctuations. The Company recorded nil and CHF 1.4 million for amortization of effective interest for the three and nine months ended September 30, 2019, respectively. Finally, the Company recognized nil and a CHF 4.5 million gain for the change in fair value of the liability related to the conversion feature.

    Primary Logo

    View Full Article Hide Full Article
  22. Company Provides Key Updates on Tau Pipeline Candidates

    LAUSANNE, Switzerland, Nov. 06, 2019 (GLOBE NEWSWIRE) --  AC Immune SA (NASDAQ:ACIU), a Swiss-based, clinical-stage biopharmaceutical company with a broad pipeline focused on neurodegenerative diseases, today announced highlights from its Key Opinion Leader (KOL) meeting focused on "untangling" Tau pathology as an important therapeutic and diagnostic target for Alzheimer's disease (AD) and other neurodegenerative diseases, held in New York City today at 12pm ET. The archived webcast of the event can be viewed here.

    The event included presentations and a roundtable discussion featuring Prof. Keith Johnson, Professor of Radiology and Neurology at Harvard Medical School and Director of Molecular…

    Company Provides Key Updates on Tau Pipeline Candidates

    LAUSANNE, Switzerland, Nov. 06, 2019 (GLOBE NEWSWIRE) --  AC Immune SA (NASDAQ:ACIU), a Swiss-based, clinical-stage biopharmaceutical company with a broad pipeline focused on neurodegenerative diseases, today announced highlights from its Key Opinion Leader (KOL) meeting focused on "untangling" Tau pathology as an important therapeutic and diagnostic target for Alzheimer's disease (AD) and other neurodegenerative diseases, held in New York City today at 12pm ET. The archived webcast of the event can be viewed here.

    The event included presentations and a roundtable discussion featuring Prof. Keith Johnson, Professor of Radiology and Neurology at Harvard Medical School and Director of Molecular Neuroimaging at Massachusetts General Hospital; Dr. Andrew Stephens, Founder, Chief Medical Officer, and Head of R&D, Life Molecular Imaging; Prof. Andrea Pfeifer, Chief Executive Officer, AC Immune SA; and Dr. Marie Kosco-Vilbois, Chief Scientific Officer, AC Immune SA.

    Key highlights include:

    • AC Immune continues to demonstrate strong progress across the Tau pipeline of potentially best-in-class small molecule, antibody, and vaccine therapeutics, as well as cutting-edge diagnostic agents
    • AC Immune received milestone payments of CHF 30 million from Eli Lilly and Company and EUR 2 million (CHF 2.2 million) from Life Molecular Imaging in 2019
    • ACI-3024 is a first-in-class, Tau-specific disease-modifying small molecule that has an excellent preclinical safety and tolerability profile, and has entered Phase 1 clinical development in collaboration with Eli Lilly and Company
    • AC Immune is advancing ACI-35.030, its optimized, 2nd generation liposomal vaccine targeting Tau, in a Phase 1b/2a clinical study in collaboration with Janssen Pharmaceuticals
    • PI-2620 is a best-in-class Tau imaging agent with excellent properties including high binding affinities to different forms of Tau, high selectivity, high brain penetration and fast washout; currently in Phase 2 clinical development in collaboration with Life Molecular Imaging

    Prof. Andrea Pfeifer, Ph.D., CEO of AC Immune, commented: "Developing therapeutics that target Tau and using Tau PET tracers to diagnose and select patients is one of the most promising areas in our search for effective treatments for neurodegenerative diseases. As such, it is one of five elements in AC Immune's Roadmap to Successful Therapies for Neurodegenerative Diseases."

    "Our unique approach targets the full spectrum of Tau pathology by inhibiting both early seeding and extracellular spreading of Tau, leveraging the Company's proprietary technology platforms, including a differentiated small molecule Tau inhibitor that acts intracellularly through a novel mechanism to address Tau pathology at the earliest stage. We are pleased to provide an overview and update on some of our key clinical programs." 

    Highlights from Prof. Pfeifer's presentation include:

    • AC Immune has a strong track record of successful execution and anticipates key clinical news flow across its Tau-focused programs:
      • Semorinemab (anti-Tau antibody partnered with Roche/Genentech): Anticipate primary completion of two ongoing Phase 2 studies in prodromal/mild AD and moderate AD is estimated for Q2 2020 and Q3 2021, respectively
      • 2nd generation anti-phospho-Tau (pTau) vaccine (ACI.35.030, partnered with Janssen): Expect interim analysis of safety and immunogenicity anticipated in Q2 2020
      • Small molecule Tau Morphomer™ (ACI-3024, partnered with Eli Lilly): Phase 1 interim data in Q4 2019 followed by readout of multiple ascending dose part in Q1 2020
      • Diagnostic Tau PET tracer (PI-2620, partnered with Life Molecular Imaging): Clinical results in progressive supranuclear palsy (PSP) expected in Q4 2020
    • Achieved key preclinical milestones for anti-alpha synuclein (a-syn) antibody and anti-TAR DNA-binding protein 43 (TDP-43) antibody
      • Both programs demonstrate high target affinity and in vivo activity
      • Investigational new drug (IND)-enabling studies expected to begin in Q1 2020 and Q2 2020 for anti-a-syn and anti-TDP-43, respectively

    Highlights of Prof. Johnson's presentation include:

    • Non-invasive positron emission tomography (PET) imaging of pathological species of amyloid beta (Abeta) and Tau proteins in the brain can help answer important questions about the progression of AD, with potential uses in clinical drug development and medical practice
    • Key findings from longitudinal clinical studies in at-risk patients include:
      • Abeta increase is observable prior to cognitive decline
      • Abeta increase is greater with higher Abeta at baseline
      • Abeta increase predicts subsequent Tau increase
      • There is a catastrophic rise in Tau once Abeta reaches a critical threshold
      • Tau changes are more closely associated with the rate of cognitive decline
      • Tau begins in more ancient parts of the brain and spreads under the influence of amyloidosis to more recently evolved regions
    • Repeated Tau PET may permit more rapid assessment of pharmacodynamic effects, which may facilitate early phase proof-of-concept trials
    • CSF fluid studies are generally consistent, rapidly improving, but with dynamic properties that are still being evaluated; plasma measures are also being developed

    Highlights from Dr. Stephens's presentation include:

    • Life Molecular Imaging and AC Immune have collaborated successfully to generate a best-in-class Tau PET tracer PI-2620
    • PI-2620 shows excellent properties with high binding affinities to different forms of Tau, high selectivity, high brain penetration and fast washout
    • PI-2620 uptake in brains of subjects with both 3R/4R and 4R Tau found in regions consistent with pathological findings
    • PI-2620 used in pharma AD drug trials to characterize subjects and assess the role of therapeutic intervention on Tau accumulation 
    • Results in PSP indicate potential of PI-2620:
      • To detect and assess PSP pathology in vivo
      • To establish earlier and more reliable diagnosis of PSP

    Highlights from Dr. Kosco-Vilbois's presentation include:

    • AC Immune's selective small molecule Tau aggregation inhibitor (Tau Morphomer™), ACI-3024, specifically targets misfolded and aggregated Tau and has shown effects on Tau pathology and neuroinflammation in an aggressive animal model of Tau pathology
    • ACI-3024 has shown an excellent nonclinical safety profile and has entered clinical a Phase 1 clinical trial as a first-in-class, Tau-specific disease-modifying small molecule for the treatment of neurodegenerative diseases characterized by misfolded Tau in collaboration with Lilly
    • AC Immune's 1st generation anti-phospho-Tau (anti-pTau) liposomal vaccine candidate, ACI-35, induced an early target-specific antibody response against pTau in the vast majority of patients and was safe at all doses tested in a Phase 1b study
    • ACI-35.030, a 2nd generation optimized liposomal vaccine, has shown an excellent safety profile and an enhanced antibody response in rodent and non-human primate studies, and is currently in a Phase 1b/2a clinical study in collaboration with Janssen

    Key Opinion Leader Biographies

    Keith Johnson, M.D.
    Prof. Keith Johnson is a Professor of Radiology and Neurology at the Harvard Medical School. He is also Associate Radiologist and Director of Molecular Neuroimaging in the Division of Nuclear Medicine and Molecular Imaging (Department of Radiology) at the Massachusetts General Hospital (MGH). Prof. Johnson serves as an associate physician and staff neurologist in the Memory Disorders Unit at the Brigham and Women's Hospital as well as a Clinical Associate in Neurology at the MGH.

    Prof. Johnson has extensive experience in imaging research in neurodegenerative diseases, is a Principal Investigator of the Harvard Aging Brain Study, and oversees the brain PET imaging program at MGH, which includes active research programs in imaging of amyloid-beta and PHF Tau, as well as Lewy body diseases and 4R Tauopathies. Prof. Johnson leads the PET component of the A4 Study, as well as several other AD clinical trials. He leads the PET Unit of the Alzheimer Clinical Trials Consortium (ACTC).

    Prof. Johnson is a practicing Neurologist in Behavioral Neurology, Associate Physician in Neurology at Massachusetts General Hospital, and Associate Neurologist in the Division of Cognitive and Behavioral Neurology at Brigham and Women's Hospital.

    Andrew Stephens, M.D., Ph.D.
    Dr. Stephens is a founder and the Chief Medical Officer and Head of Research and Development for Life Molecular Imaging, GmbH. He has more than 25 years of experience in the pharmaceutical industry, primarily in the areas of translational medicine, and diagnostic imaging of neurodegenerative, oncological and cardiovascular diseases. Dr. Stephens was responsible for regulatory approval and market authorization of Neuraceq (18F-florbetaben) in US, EU, South Korea, and Japan.

    Before joining the current company, he was VP, Head Experimental Medicine Oncology/Diagnostic Imaging for Bayer Pharma. Dr. Stephens received an M.D. and a Ph.D. in biochemistry, biophysics and genetics from the University of Colorado. He was Board certified in Internal Medicine and had a clinical practice before entering pharmaceutical development. He began his pharmaceutical industry career investigating RNA aptamers at NeXagen/NeXstar, and Gilead Sciences. As Senior Director of Translational Medicine at OSI Pharmaceuticals he was responsible for early clinical studies of several anti-cancer oral signal transduction inhibitors. He is an author of more than 150 original articles, abstracts and patents.

    About AC Immune
    AC Immune SA is a Nasdaq-listed clinical-stage biopharmaceutical company, which aims to become a global leader in Precision Medicine for neurodegenerative diseases. The Company is utilizing two proprietary discovery platforms, SupraAntigenTM and MorphomerTM, to design, discover and develop small molecule and biological therapeutics as well as diagnostic products intended to diagnose, prevent and modify neurodegenerative diseases caused by misfolding proteins. The Company's pipeline features nine therapeutic and three diagnostic product candidates, with five currently in clinical trials. It has collaborations with major pharmaceutical companies including Roche/Genentech, Lilly and Janssen.

    For further information, please contact:

    U.S. Investors
    Joshua Drumm, Ph.D.
    AC Immune Investor Relations
    Phone: +1 646 876 5538
    E-mail:
    U.S. Media
    Katie Gallagher
    LaVoieHealthScience
    Phone: +1 617 792 3937
    E-mail:
       
    Head of Global Communications
    Judith Moore
    AC Immune
    Phone: +41 79 826 63 82
    Email:
    European Investors
    Chris Maggos
    LifeSci Advisors
    Phone: +41 79 367 6254 
    E-mail:

    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.

    Primary Logo

    View Full Article Hide Full Article
  23. LAUSANNE, Switzerland, Oct. 24, 2019 (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 will host a key opinion leader (KOL) meeting focused on pathological Tau protein as a therapeutic target and diagnostic biomarker for Alzheimer's and other neurodegenerative diseases. The event will take place in New York City on Wednesday, November 6, 2019.

    Neurodegenerative diseases, including Alzheimer's disease, are associated with the presence of defective Tau protein in the brain. Imaging studies show that Tau pathology correlates strongly with the rate of cognitive decline, making Tau an important therapeutic target…

    LAUSANNE, Switzerland, Oct. 24, 2019 (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 will host a key opinion leader (KOL) meeting focused on pathological Tau protein as a therapeutic target and diagnostic biomarker for Alzheimer's and other neurodegenerative diseases. The event will take place in New York City on Wednesday, November 6, 2019.

    Neurodegenerative diseases, including Alzheimer's disease, are associated with the presence of defective Tau protein in the brain. Imaging studies show that Tau pathology correlates strongly with the rate of cognitive decline, making Tau an important therapeutic target, as well as a promising biomarker for earlier diagnosis and tracking disease progression. Therefore, targeting Tau pathology is a key element of AC Immune's Roadmap to Successful Therapies for Neurodegenerative Diseases. The Company's unique approach targets the full spectrum of Tau pathology by detecting and inhibiting both early seeding and extracellular spreading of Tau with its best-in-class small molecules, antibodies and vaccines, as well as its cutting-edge Tau diagnostic agents. The event will include presentations from leading KOLs as well as a discussion of key preclinical and clinical data from AC Immune's therapeutic development programs and an outline of key programs expected to enter late-stage development in the next two years.

    Company and KOL presentations will be followed by an interactive roundtable discussion between the audience, Dr. Keith Johnson, Massachusetts General Hospital, Professor Andrea Pfeifer, Ph.D., CEO, and Marie Kosco-Vilbois, Ph.D., Chief Scientific Officer of AC Immune SA and Dr. Andrew Stephens Chief Medical Officer of Life Molecular Imaging. The event will be webcast live and archived on the Investor Page of AC Immune's website, ir.acimmune.com.

    Key Opinion Leader Biographies

    Keith Johnson, M.D.
    Dr. Keith Johnson is a Professor of Radiology and Neurology at the Harvard Medical School. He is also Associate Radiologist and Director of Molecular Neuroimaging in the Division of Nuclear Medicine and Molecular Imaging (Department of Radiology) at the Massachusetts General Hospital (MGH). Dr. Johnson serves as an associate physician and staff neurologist in the Memory Disorders Unit at the Brigham and Women's Hospital as well as a Clinical Associate in Neurology at the MGH.

    Dr. Johnson has extensive experience in imaging research in neurodegenerative diseases, is a Principal Investigator of the Harvard Aging Brain Study, and oversees the brain PET imaging program at MGH, which includes active research programs in imaging of amyloid-beta and PHF Tau, as well as Lewy body diseases and 4R Tauopathies. Dr. Johnson leads the PET component of the A4 Study, as well as several other AD clinical trials. He leads the PET Unit of the Alzheimer Clinical Trials Consortium (ACTC).

    Dr. Johnson is a practicing Neurologist in Behavioral Neurology, Associate Physician in Neurology at Massachusetts General Hospital, and Associate Neurologist in the Division of Cognitive and Behavioral Neurology at Brigham and Women's Hospital.

    Andrew Stephens, M.D., Ph.D.
    Dr. Stephens is a founder and the Chief Medical Officer and Head of Research and Development for Life Molecular Imaging, GmbH. He has more than 25 years of experience in the pharmaceutical industry, primarily in the areas of translational medicine, and diagnostic imaging of neurodegenerative, oncological and cardiovascular diseases. Dr. Stephens was responsible for regulatory approval and market authorization of Neuraceq (18F-florbetaben) in US, EU, South Korea, and Japan.

    Before joining the current company, he was VP, Head Experimental Medicine Oncology/Diagnostic Imaging for Bayer Pharma. Dr. Stephens received an M.D. and a Ph.D. in biochemistry, biophysics and genetics from the University of Colorado. He was Board certified in Internal Medicine and had a clinical practice before entering pharmaceutical development. He began his pharmaceutical industry career investigating RNA aptamers at NeXagen/NeXstar, and Gilead Sciences. As Senior Director of Translational Medicine at OSI Pharmaceuticals he was responsible for early clinical studies of several anti-cancer oral signal transduction inhibitors. He is an author of more than 150 original articles, abstracts and patents.

    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 Janssen Pharmaceuticals Inc.

    For further information, please contact:

    US Investors
    Joshua Drumm, Ph.D.
    AC Immune Investor Relations
    Phone:  +1 646 876 5538
    E-mail:
    US Media
    Katie Gallagher
    LaVoieHealthScience
    Phone: +1 617 792 3937
    E-mail:
       
    Head of Global Communications
    Judith Moore
    AC Immune
    Phone: +44 7932 053 829
    E-mail:
    European Investors & Media
    Chris Maggos
    LifeSci Advisors
    Phone: +41 79 367 6254
    E-mail:

    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.

    Primary Logo

    View Full Article Hide Full Article
  24. Lilly to pay CHF30 million development milestone

    Recognizes progress in ACI-3024 Small Molecule Tau Morphomer™ development

    LAUSANNE, Switzerland, Sept. 20, 2019 (GLOBE NEWSWIRE) -- AC Immune SA (NASDAQ:ACIU), a Swiss-based, clinical-stage biopharmaceutical company, today announced that it will receive the first milestone payment of CHF30 million from Eli Lilly and Company on or before October 7, 2019. This payment is a recognition of progress in the collaboration between the two companies and follows initiation in July 2019 of the Phase 1 study of ACI-3024, a first-in-class investigational oral small molecule Tau Morphomer™ in development for treatment of Alzheimer's disease (AD) and other neurodegenerative disorders. A second milestone payment…

    Lilly to pay CHF30 million development milestone

    Recognizes progress in ACI-3024 Small Molecule Tau Morphomer™ development

    LAUSANNE, Switzerland, Sept. 20, 2019 (GLOBE NEWSWIRE) -- AC Immune SA (NASDAQ:ACIU), a Swiss-based, clinical-stage biopharmaceutical company, today announced that it will receive the first milestone payment of CHF30 million from Eli Lilly and Company on or before October 7, 2019. This payment is a recognition of progress in the collaboration between the two companies and follows initiation in July 2019 of the Phase 1 study of ACI-3024, a first-in-class investigational oral small molecule Tau Morphomer™ in development for treatment of Alzheimer's disease (AD) and other neurodegenerative disorders. A second milestone payment of CHF30 million is scheduled in Q1 2020 linked to achievement of further development milestones.

    Prof. Andrea Pfeifer, CEO of AC Immune SA, commented: "Lilly has brought substantial experience in neurology, and particularly in Alzheimer's disease, to this collaboration. This milestone payment recognizes that the development of the lead small molecule MorphomerTM in our collaboration, ACI-3024, is progressing. At AC Immune, we are proud to be advancing in collaboration with our partners the clinical development of three additional products targeting Tau – an antibody, a therapeutic vaccine and a diagnostic biomarker – for treatment of Alzheimer's and other neurodegenerative diseases."

    "The start of the ACI-3024 Phase 1 study, represents an important advancement in the broader effort we are making and further expands our robust clinical pipeline to address neurodegenerative diseases, in particular for therapeutics and diagnostics targeting Tau."

    In the complex treatment paradigm for AD, Tau pathology is a potential therapeutic target. Tau spreads with a characteristic spatiotemporal pattern throughout the brain that coincides with both clinical symptoms and disease progression in AD. Slowing the propagation of Tau pathology may slow disease progression and reduce cognitive decline. Anti-Tau therapies already have shown promise in slowing the progression of Tau pathology in animal models.

    ACI-3024 is the lead molecule being developed in the license and collaboration agreement between AC Immune and Lilly to research and develop small molecule Tau aggregation inhibitors for the treatment of AD and other neurodegenerative diseases. The collaboration combines AC Immune's proprietary Morphomer™ discovery platform and early development experience with Lilly's established clinical development expertise and commercial capabilities in central nervous system disorders. Under the agreement AC Immune is conducting the initial Phase 1 development of the Morphomer™ Tau aggregation inhibitors while Lilly will fund and conduct additional research and further clinical development.

    The Phase 1 trial initiated in July is a randomized, placebo controlled, double blind, sequential single and multiple ascending dose study that aims to assess the safety, tolerability, pharmacokinetics, and pharmacodynamics of ACI-3024 in healthy volunteers.

    About the AC Immune and Lilly and Company Agreement

    Under the terms of the agreement, Lilly received worldwide commercialization rights for Tau aggregation inhibitors, including in the area of Alzheimer's disease. AC Immune received an upfront payment of CHF80 million as well as $50 million in exchange for a note, convertible to equity at a premium. AC Immune is also eligible to receive an additional CHF30 million near-term milestone in Q1 2020, and is eligible to receive other development, regulatory and commercial milestones, up to approximately CHF1.7 billion, and tiered royalty payments in the low double digits.

    About AC Immune SA
    AC Immune SA is a Nasdaq-listed clinical-stage biopharmaceutical company, which aims to become a global leader in precision medicine for neurodegenerative diseases. The Company is utilizing two proprietary discovery platforms, SupraAntigenTM and MorphomerTM, to design, discover and develop small molecule and biological therapeutics as well as diagnostic products intended to diagnose, prevent and modify neurodegenerative diseases caused by misfolding proteins. The Company's pipeline features nine therapeutic and three diagnostic product candidates, with five currently in clinical trials. It has collaborations with major pharmaceutical companies including Roche/Genentech, Lilly, and Janssen Pharmaceuticals Inc.

    For further information, please contact:

    US Investors
    Joshua Drumm, Ph.D.
    AC Immune Investor Relations
    Phone:  +1 646 876 5538
    E-mail:
    US Media
    Katie Gallagher
    LaVoieHealthScience
    Phone: +1 617 792 3937
    E-mail:

     
    European Media
    Judith Moore
    AC Immune Global Communication Lead
    Phone: +44 7932 053829
    E-mail:
    European Investors & Media
    Chris Maggos
    LifeSci Advisors
    Phone: +41 79 367 6254
    E-mail:  

    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.

    Primary Logo

    View Full Article Hide Full Article
  25. Next generation Tau tracer offers potential for earlier and more accurate diagnosis in Alzheimer's and neurodegenerative diseases

    The clinical milestone highlights the strength of AC Immune's Tau pipeline, one of the broadest in the field

    Reflects the compelling trend for positive data across the field on pathological Tau and its pivotal role in neurodegenerative diseases

    LAUSANNE, Switzerland, Sept. 17, 2019 (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 has received a milestone payment from its partner Life Molecular Imaging in connection with the initiation of a Phase 2 study of the Tau positron-emission…

    Next generation Tau tracer offers potential for earlier and more accurate diagnosis in Alzheimer's and neurodegenerative diseases

    The clinical milestone highlights the strength of AC Immune's Tau pipeline, one of the broadest in the field

    Reflects the compelling trend for positive data across the field on pathological Tau and its pivotal role in neurodegenerative diseases

    LAUSANNE, Switzerland, Sept. 17, 2019 (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 has received a milestone payment from its partner Life Molecular Imaging in connection with the initiation of a Phase 2 study of the Tau positron-emission tomography (PET) tracer PI-2620.

    PI-2620 is a next generation Tau PET tracer developed using AC Immune's proprietary Morphomer™ discovery platform in a research collaboration with Life Molecular Imaging. It binds to Tau deposits which, along with beta-amyloid plaques, represent a critical pathological hallmark of Alzheimer's disease (AD). Tau deposits also play an important role in other neurodegenerative diseases.

    The Phase 2 longitudinal study is being conducted in the UK and is expected to last approximately three years, with the overall goal being to evaluate PI-2620 as a targeted radiopharmaceutical for the detection of Tau deposits in the human brain. The data generated are intended to be used for obtaining regulatory approval in the U.S. and Europe.

    Prof. Andrea Pfeifer, CEO of AC Immune SA, commented: "The clinical advancement of PI-2620 is based on its excellent properties and imaging characteristics, and it further reinforces the proficiency of AC Immune's Morphomer™ technology and our ability to establish highly productive partnerships with well-respected companies such as Life Molecular Imaging. Treating earlier and targeting Tau are both key elements of our Roadmap to Successful Therapies for Neurodegenerative Diseases.

    "There is a growing body of clinical evidence that Tau pathology drives disease progression, and this new Phase 2 trial further broadens AC Immune's world leading anti-Tau clinical pipeline, which also includes therapeutic antibodies (partnered with Roche/Genentech), small molecule inhibitors (partnered with Eli Lilly), and vaccines (partnered with Janssen). We are advancing these programs in parallel to generate robust clinical data, having most recently vaccinated the first patient in a Phase 1b/2a study of our clinically advanced anti-phospho-Tau vaccine candidate ACI-35.030."

    The open label Phase 2 study will evaluate the safety and imaging characteristics of PI-2620 as a PET radioligand for imaging Tau deposition in the brains of patients with mild cognitive impairment (MCI) and mild to moderate AD in comparison with non-demented control (NDC) participants.

    PI-2620 was discovered and developed in a research collaboration between AC Immune and Life Molecular Imaging. It has demonstrated robust brain uptake and fast wash-out in non-target regions, a broad imaging window between 30 and 90 minutes post-injection (p.i.) for AD, and excellent reproducibility between test and retest scans. The absence of significant off-target binding enables PI-2620 to detect and quantify early Tau deposition in the brain. PI-2620 also shows promise for non-AD Tauopathies like progressive supranuclear palsy (PSP). Life Molecular Imaging has the exclusive, worldwide license for research, development and commercialization of Tau PET tracers generated within the discovery 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 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 Janssen Pharmaceuticals Inc.

         
    For further information, please contact:
         
    US Investors   US Media
    Joshua Drumm, Ph.D.   Katie Gallagher
    AC Immune Investor Relations   LaVoieHealthScience
    Phone: +1 646 876 5538   Phone: +1 617 792 3937
    E-mail:   E-mail:
         
    European Media   European Investors
    Judith Moore   Chris Maggos
    AC Immune Global Communication Lead   LifeSci Advisors
    Phone: +44 7932 053829   Phone: +41 79 367 6254
    Email:   E-mail:
         

    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.

    Primary Logo

    View Full Article Hide Full Article
  26. LAUSANNE, Switzerland, Sept. 04, 2019 (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 Michael J. Fox Foundation for Parkinson's Research (MJFF) has awarded a new grant for the Company's pioneering alpha-synuclein (a-syn) positron-emission tomography (PET) tracer program.

    Over the last four years, AC Immune has received continuous grant support from MJFF to accelerate development of a-syn PET tracers. If successful, AC Immune's program could deliver the world's first imaging agent capable of accurately detecting and monitoring progression of Parkinson's disease (PD). An effective a-syn tracer would also enable…

    LAUSANNE, Switzerland, Sept. 04, 2019 (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 Michael J. Fox Foundation for Parkinson's Research (MJFF) has awarded a new grant for the Company's pioneering alpha-synuclein (a-syn) positron-emission tomography (PET) tracer program.

    Over the last four years, AC Immune has received continuous grant support from MJFF to accelerate development of a-syn PET tracers. If successful, AC Immune's program could deliver the world's first imaging agent capable of accurately detecting and monitoring progression of Parkinson's disease (PD). An effective a-syn tracer would also enable and accelerate the development of novel PD therapies as a powerful tool for measuring the effect of novel drugs on a-syn pathology in the brain.

    Prof. Andrea Pfeifer, CEO of AC Immune SA, commented: "We are very proud to be working together with MJFF on our a-syn PET tracer program, which offers patients the potential for earlier diagnosis of PD and facilitates the development of therapeutic intervention strategies. AC Immune's precision medicine approach to treating neurodegenerative diseases focuses on the creation of imaging agents capable of earlier detection and disease monitoring, as well as the development of a broad pipeline of effective therapeutic candidates focused on the prevention and treatment of these debilitating conditions."

    The program has generated multiple compounds that bind with high-affinity and selectivity to human PD brain-derived, pathological a-syn in preclinical studies. A lead a-syn PET tracer candidate entered clinical trials earlier this year — also with MJFF funding — focused on imaging of pathological a-syn in PD and other synucleinopathies. AC Immune's a-syn PET tracers are derived from the Company's proprietary small molecule MorphomerTM discovery platform. The Company is also advancing the development of oral small molecule a-syn inhibitors and SupraAntigenTM-derived anti-a-syn antibodies as novel therapeutic candidates targeting PD and a-syn-related NeuroOrphan diseases.

    Dr. Jan Stöhr, Head of Non-Alzheimer's Disease Proteinopathies at AC Immune, will give an oral presentation related to the development of the Company's a-syn PET tracer at MJFF's 13th Annual Parkinson's Disease Therapeutics Conference on October 15th in New York City.

    About AC Immune
    AC Immune SA is a Nasdaq-listed clinical-stage biopharmaceutical company, which aims to become a global leader in Precision Medicine for neurodegenerative diseases. The Company is utilizing two proprietary discovery platforms, SupraAntigenTM and MorphomerTM, to design, discover and develop small molecule and biological therapeutics as well as diagnostic products intended to diagnose, prevent and modify neurodegenerative diseases caused by misfolded proteins. The Company's pipeline features nine therapeutic and three diagnostic product candidates, with five currently in clinical trials. It has collaborations with major pharmaceutical companies including Roche/Genentech, Eli Lilly and Janssen Pharmaceuticals Inc.

    As a strategic leader in the field of neurodegenerative diseases, AC Immune has developed a five point Roadmap to Successful Therapies for Neurodegenerative Diseases that recognizes the importance of treating earlier, targeting Tau, focusing on more homogeneous populations, precision medicine and exploring neuroinflammation as a target.

    For further information, please contact:

    U.S. Investors
    Joshua Drumm, Ph.D.
    AC Immune Investor Relations
    Phone: +1 646 876 5538
    E-mail:
    U.S. Media
    Katie Gallagher
    LaVoieHealthScience
    Phone: +1 617 792 3937
    E-mail:

    European Media
    Judith Moore
    AC Immune Global Communication Lead
    Phone: +44 7932 053829
    Email:

    European Investors
    Chris Maggos
    LifeSci Advisors
    Phone: +41 79 367 6254 
    E-mail:

    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.

    Primary Logo

    View Full Article Hide Full Article