ACIU AC Immune SA

5.41
-0.17  -3%
Previous Close 5.58
Open 5.58
52 Week Low 4.07
52 Week High 13
Market Cap $388,120,352
Shares 71,741,285
Float 26,898,670
Enterprise Value $123,704,887
Volume 90,210
Av. Daily Volume 439,278
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Drug Pipeline

Drug Stage Notes
ACI-35.030
Alzheimer’s Disease
Phase 1/2
Phase 1/2
Phase 1b/1a trial ongoing.
ACI-3024
Alzheimer’s disease
Phase 1
Phase 1
Phase 1 trial has completed.
ACI-24
Alzheimer’s disease (AD)
Phase 2
Phase 2
Phase 2 12-month analysis has been completed.
Semorinemab
Alzheimer’s disease
Phase 2
Phase 2
Phase 2 top-line data did not meet endpoints - September 23, 2020.
Semorinemab - LAURIET
Alzheimer’s disease
Phase 2
Phase 2
Phase 2 trial ongoing as of September 23, 2020.
ACI-24 (anti-Abeta vaccine)
Alzheimer's disease-like characteristics in individuals with Down syndrome
Phase 1b
Phase 1b
Phase 1b presentation at AAIC July 29, 2020.
Crenezumab - CREAD 2
Alzheimer’s disease
Phase 3
Phase 3
Phase 3 trial terminated following interim analysis indicating primary endpoint would not be met.
Crenezumab - CREAD 1
Alzheimer’s disease
Phase 3
Phase 3
Phase 3 trial terminated following interim analysis indicating primary endpoint would not be met.

Latest News

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

    Appointment reaffirms AC Immune's scientific leadership in neurodegeneration

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

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

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

    Appointment reaffirms AC Immune's scientific leadership in neurodegeneration

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

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

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

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

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

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

    About AC Immune SA

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

    For further information, please contact:

    Head of Investor Relations

    Joshua Drumm, Ph.D.

    AC Immune

    Phone: +1 917 809 0814

    Email:

    US Media

    Katie Gallagher

    LaVoie HealthScience

    Phone: +1 617 792 3937

    Email:

      
    Global Head of Communications

    Judith Moore

    AC Immune

    Phone: +41 79 826 63 82

    Email:

    European Investors & Media

    Chris Maggos

    LifeSci Advisors

    Phone: +41 79 367 6254

    Email:

    Forward looking statements

    This press release contains statements that constitute "forward-looking statements" within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. Forward-looking statements are statements other than historical fact and may include statements that address future operating, financial or business performance or AC Immune's strategies or expectations. In some cases, you can identify these statements by forward-looking words such as "may," "might," "will," "should," "expects," "plans," "anticipates," "believes," "estimates," "predicts," "projects," "potential," "outlook" or "continue," and other comparable terminology. Forward-looking statements are based on management's current expectations and beliefs and involve significant risks and uncertainties that could cause actual results, developments and business decisions to differ materially from those contemplated by these statements. These risks and uncertainties include those described under the captions "Item 3. Key Information – Risk Factors" and "Item 5. Operating and Financial Review and Prospects" in AC Immune's Annual Report on Form 20-F and other filings with the Securities and Exchange Commission. These include: the impact of Covid-19 on our business, suppliers, patients and employees and any other impact of Covid-19. Forward-looking statements speak only as of the date they are made, and AC Immune does not undertake any obligation to update them in light of new information, future developments or otherwise, except as may be required under applicable law. All forward-looking statements are qualified in their entirety by this cautionary statement.



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

    Appointment reaffirms AC Immune's scientific leadership in neurodegeneration

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

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

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

    Appointment reaffirms AC Immune's scientific leadership in neurodegeneration

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

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

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

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

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

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

    About AC Immune SA

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

    For further information, please contact:

    Head of Investor Relations

    Joshua Drumm, Ph.D.

    AC Immune

    Phone: +1 917 809 0814

    Email:

    US Media

    Katie Gallagher

    LaVoie HealthScience

    Phone: +1 617 792 3937

    Email:

      
    Global Head of Communications

    Judith Moore

    AC Immune

    Phone: +41 79 826 63 82

    Email:

    European Investors & Media

    Chris Maggos

    LifeSci Advisors

    Phone: +41 79 367 6254

    Email:

    Forward looking statements

    This press release contains statements that constitute "forward-looking statements" within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. Forward-looking statements are statements other than historical fact and may include statements that address future operating, financial or business performance or AC Immune's strategies or expectations. In some cases, you can identify these statements by forward-looking words such as "may," "might," "will," "should," "expects," "plans," "anticipates," "believes," "estimates," "predicts," "projects," "potential," "outlook" or "continue," and other comparable terminology. Forward-looking statements are based on management's current expectations and beliefs and involve significant risks and uncertainties that could cause actual results, developments and business decisions to differ materially from those contemplated by these statements. These risks and uncertainties include those described under the captions "Item 3. Key Information – Risk Factors" and "Item 5. Operating and Financial Review and Prospects" in AC Immune's Annual Report on Form 20-F and other filings with the Securities and Exchange Commission. These include: the impact of Covid-19 on our business, suppliers, patients and employees and any other impact of Covid-19. Forward-looking statements speak only as of the date they are made, and AC Immune does not undertake any obligation to update them in light of new information, future developments or otherwise, except as may be required under applicable law. All forward-looking statements are qualified in their entirety by this cautionary statement.



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

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

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

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

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

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

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

    Q3 2020 Research & Development Updates and Highlights:

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

    Update on Covid-19

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

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

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

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

    About AC Immune SA

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

    For further information, please contact:

    Head of Investor Relations

    Joshua Drumm, Ph.D.

    AC Immune

    Phone: +1 917 809 0814

    Email:



     
    US Media

    Katie Gallagher

    LaVoieHealthScience

    Phone: +1 617 792 3937

    Email:



     
    Global Head of Communications

    Judith Moore

    AC Immune

    Phone: +41 79 826 63 82

    Email:



    European Investors & Media

    Chris Maggos

    LifeSci Advisors

    Phone: +41 79 367 6254

    Email:

    Forward looking statements

    This press release contains statements that constitute "forward-looking statements" within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. Forward-looking statements are statements other than historical fact and may include statements that address future operating, financial or business performance or AC Immune's strategies or expectations. In some cases, you can identify these statements by forward-looking words such as "may," "might," "will," "should," "expects," "plans," "anticipates," "believes," "estimates," "predicts," "projects," "potential," "outlook" or "continue," and other comparable terminology. Forward-looking statements are based on management's current expectations and beliefs and involve significant risks and uncertainties that could cause actual results, developments and business decisions to differ materially from those contemplated by these statements. These risks and uncertainties include those described under the captions "Item 3. Key Information – Risk Factors" and "Item 5. Operating and Financial Review and Prospects" in AC Immune's Annual Report on Form 20-F and other filings with the Securities and Exchange Commission. These include: the impact of Covid-19 on our business, suppliers, patients and employees and any other impact of Covid-19. Forward-looking statements speak only as of the date they are made, and AC Immune does not undertake any obligation to update them in light of new information, future developments or otherwise, except as may be required under applicable law. All forward-looking statements are qualified in their entirety by this cautionary statement.

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

    2020
     As of December 31,

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



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

    Ended September 30,
      

    For the Nine Months

    Ended September 30,


     2020  2019  2020

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



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

    Ended September 30,


     For the Nine Months

    Ended September 30,


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

      

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

    Ended September 30


     For the Nine Months

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

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



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

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

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

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

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

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

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

    Jefferies Virtual London Healthcare Conference

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

    Format: Virtual Presentation followed by Q&A

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

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

    1 2019, Nelson et al. Consensus working group report

    About AC Immune SA

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

    For further information, please contact:

    Head of Investor Relations

    Joshua Drumm, Ph.D.

    AC Immune

    Phone: +1 917 809 0814

    Email:

    US Media

    Katie Gallagher

    LaVoie Health Science

    Phone: +1 617 792 3937

    Email:

      
    Global Head of Communications

    Judith Moore

    AC Immune

    Phone: +41 79 826 63 82

    Email:

    European Investors & Media

    Chris Maggos

    LifeSci Advisors

    Phone: +41 79 367 6254

    Email:

    Forward looking statements

    This press release contains statements that constitute "forward-looking statements" within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. Forward-looking statements are statements other than historical fact and may include statements that address future operating, financial or business performance or AC Immune's strategies or expectations. In some cases, you can identify these statements by forward-looking words such as "may," "might," "will," "should," "expects," "plans," "anticipates," "believes," "estimates," "predicts," "projects," "potential," "outlook" or "continue," and other comparable terminology. Forward-looking statements are based on management's current expectations and beliefs and involve significant risks and uncertainties that could cause actual results, developments and business decisions to differ materially from those contemplated by these statements. These risks and uncertainties include those described under the captions "Item 3. Key Information – Risk Factors" and "Item 5. Operating and Financial Review and Prospects" in AC Immune's Annual Report on Form 20-F and other filings with the Securities and Exchange Commission. These include: the impact of Covid-19 on our business, suppliers, patients and employees and any other impact of Covid-19. Forward-looking statements speak only as of the date they are made, and AC Immune does not undertake any obligation to update them in light of new information, future developments or otherwise, except as may be required under applicable law. All forward-looking statements are qualified in their entirety by this cautionary statement.

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

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

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

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

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

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

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

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

    About TDP-43

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

    About AC Immune SA

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

    About WuXi Biologics

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

    For further information, please contact:

    Head of Investor Relations

    Joshua Drumm, Ph.D.

    AC Immune

    Phone: +1 917 809 0814

    Email:



    US Media

    Katie Gallagher

    LaVoieHealthScience

    Phone: +1 617 792 3937

    Email:



    Global Head of Communications

    Judith Moore

    AC Immune

    Phone: +41 79 826 63 82

    Email:



    European Investors & Media

    Chris Maggos

    LifeSci Advisors

    Phone: +41 79 367 6254

    Email:

    WuXi Biologics

    Media

    WuXi Biologics

    Investor

    I

    Forward looking statements

    This press release contains statements that constitute "forward-looking statements" within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. Forward-looking statements are statements other than historical fact and may include statements that address future operating, financial or business performance or AC Immune's strategies or expectations. In some cases, you can identify these statements by forward-looking words such as "may," "might," "will," "should," "expects," "plans," "anticipates," "believes," "estimates," "predicts," "projects," "potential," "outlook" or "continue," and other comparable terminology. Forward-looking statements are based on management's current expectations and beliefs and involve significant risks and uncertainties that could cause actual results, developments and business decisions to differ materially from those contemplated by these statements. These risks and uncertainties include those described under the captions "Item 3. Key Information – Risk Factors" and "Item 5. Operating and Financial Review and Prospects" in AC Immune's Annual Report on Form 20-F and other filings with the Securities and Exchange Commission. These include: the impact of Covid-19 on our business, suppliers, patients and employees and any other impact of Covid-19. Forward-looking statements speak only as of the date they are made, and AC Immune does not undertake any obligation to update them in light of new information, future developments or otherwise, except as may be required under applicable law. All forward-looking statements are qualified in their entirety by this cautionary statement.

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