ACIU AC Immune SA

6.66
+0.45  (+7%)
Previous Close 6.21
Open 6.45
52 Week Low 4.42
52 Week High 13
Market Cap $483,866,676
Shares 72,652,654
Float 31,782,720
Enterprise Value $215,063,173
Volume 311,161
Av. Daily Volume 224,715
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Upcoming Catalysts

Drug Stage Catalyst Date
ACI-24
Alzheimer’s disease (AD)
Phase 2
Phase 2
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JACI-35.054 alternative anti-pTau vaccine
Alzheimer’s disease
Phase 1/2
Phase 1/2
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Semorinemab (LAURIET)
Alzheimer’s disease
Phase 2
Phase 2
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ACI-24 (anti-Abeta vaccine)
Alzheimer's disease-like characteristics in individuals with Down syndrome
Phase 1b
Phase 1b
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ACI-35.030
Alzheimer’s Disease
Phase 1/2
Phase 1/2
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Drug Pipeline

Drug Stage Notes
Semorinemab
Alzheimer’s disease
Phase 2
Phase 2
Phase 2 top-line data did not meet endpoints - September 23, 2020.
ACI-3024
Alzheimer’s disease
Phase 1
Phase 1
Phase 1 trial has completed.
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. Previous interim results showing strong safety and potent immunogenicity support trial expansion and advancement of ACI-35.030 into Phase 2b/3

    Alternative vaccine candidate also advances to second highest dose group based on encouraging interim results

    LAUSANNE, Switzerland, May 17, 2021 (GLOBE NEWSWIRE) -- AC Immune SA (NASDAQ:ACIU), a clinical-stage biopharmaceutical company pioneering precision medicine for neurodegenerative diseases, today announced that the Company and its strategic partner Janssen Pharmaceuticals, Inc., have expanded the ongoing Phase 1b/2a clinical trial of the Companies' first-in-class anti-phosphorylated-Tau (pTau) vaccine candidate ACI-35.030 for the treatment of Alzheimer's disease (AD). The trial expansion…

    Previous interim results showing strong safety and potent immunogenicity support trial expansion and advancement of ACI-35.030 into Phase 2b/3

    Alternative vaccine candidate also advances to second highest dose group based on encouraging interim results

    LAUSANNE, Switzerland, May 17, 2021 (GLOBE NEWSWIRE) -- AC Immune SA (NASDAQ:ACIU), a clinical-stage biopharmaceutical company pioneering precision medicine for neurodegenerative diseases, today announced that the Company and its strategic partner Janssen Pharmaceuticals, Inc., have expanded the ongoing Phase 1b/2a clinical trial of the Companies' first-in-class anti-phosphorylated-Tau (pTau) vaccine candidate ACI-35.030 for the treatment of Alzheimer's disease (AD). The trial expansion, which is based on encouraging interim safety, tolerability and immunogenicity results to date, specifically includes vaccination of additional AD patients at the second highest dose to support continued development of ACI-35.030 into Phase 2b/3. In parallel, the trial continues to evaluate patients in the highest dose cohort, for which the first interim results will be available in Q4 2021.

    Interim results from the low and second highest dose groups of the Phase 1b/2a trial showed that ACI-35.030 vaccination generated a potent antigen-specific antibody response against pTau in 100% of older patients with early AD with no clinically relevant safety concerns observed to date. These data, as well as additional interim Phase 1b/2a results, will be presented at an upcoming medical congress.

    Long-term immunization with vaccines represents a valuable strategy for treatment and potentially prevention of AD and other neurodegenerative diseases. ACI-35.030 is the first AD vaccine candidate designed to generate antibodies that specifically target pathological pTau proteins in the brain. Anti-pTau antibodies generated continually in the body by ACI-35.030 have the potential to reduce and prevent the spread and seeding of Tau pathology, which is a major hallmark of AD.

    Prof. Andrea Pfeifer, CEO of AC Immune SA, commented: "Expanding the second highest dose cohort will increase the amount of immunogenicity and safety data and potentially facilitate advancement into a Phase 2b/3 trial. We look forward to presenting interim results later this year and further assessing the potential of our highly promising vaccine candidate with our collaboration partner Janssen Pharmaceuticals, Inc. In parallel, we are pleased to evaluate a second alternative pTau vaccine candidate, which may provide additional optionality for future development."

    In addition to ACI-35.030, AC Immune and Janssen Pharmaceuticals, Inc., are evaluating an exploratory alternative pTau vaccine candidate, JACI-35.054, in the current Phase 1b/2a trial. Based on encouraging interim safety, tolerability and immunogenicity results from the JACI-35.054 low-dose group, enrollment of a higher dose group has been initiated.

    Prof. Philip Scheltens, Professor of Neurology at Amsterdam UMC Alzheimer Center and Principal Investigator of the Phase 1b/2a study, commented: "Pathological pTau can now be detected very early in the disease process, years before Tau deposits accumulate, enabling the identification of people at risk of developing AD. Therefore, a vaccine like ACI-35.030 might not only represent a breakthrough in AD therapy, but it could be part of a prevention strategy for AD."

    AC Immune is developing ACI-35.030 and JACI-35.054 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 the SupraAntigen™ platform

    AC Immune's clinically validated SupraAntigenTM platform uses proprietary liposomes to rapidly generate novel vaccines (SupraAntigen™-V) for active immunization as well as best-in-class monoclonal antibodies (SupraAntigen™-A) for passive immunization against key neurodegenerative disease targets. Antibodies generated by the platform are highly specific for the pathological conformations of misfolded proteins and have shown strong safety. The SupraAntigen™ platform has successfully generated two vaccines and two antibody candidates that have been validated in clinical studies and has led to multiple global partnerships with world-leading pharmaceutical companies. In addition to targeting Amyloid-beta and Tau, AC Immune has generated conformation-specific antibodies against emerging neurodegenerative disease targets including as alpha-synuclein, TDP-43 and the NLRP3 inflammasome pathway.

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

    The Phase 1b/2a study 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 and JACI-35.054 in patients with early AD. Secondary objectives will assess additional immunogenicity parameters, while exploratory endpoints will include notable biomarkers of progression of AD as well as clinical assessments. This Phase 1b/2a study evaluating ACI-35.030 and JACI-35.054 was initiated in Q3 2019 and is currently ongoing.

    About AC Immune SA

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

    For further information, please contact:

    Head of Investor Relations and

    Corporate Communications

    Joshua Drumm, Ph.D.

    AC Immune

    Phone : +1 917 809 0814

    Email:

    U.S. Media

    Katie Gallagher

    LaVoie Health Science

    Phone: +1 617 792 3937

    Email:

     European Investors & Media

    Chris Maggos

    LifeSci Advisors

    Phone : +41 79 367 6254

    Email :

    Forward-looking statements

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



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  2. Patrik De Haes M.D. becomes Non-executive Chairman

    Leuven, BE and Boston, MA, US May 17, 20217:30 AM CETOxurion NV (Euronext Brussels: OXUR), a biopharmaceutical company developing next generation standard of care ophthalmic therapies, with a clinical stage portfolio in retinal vascular disorders, announces in a planned succession, the promotion of Tom Graney, CFA from Chief Financial Officer (CFO) to Chief Executive Officer (CEO) of the company. He takes over from Dr. Patrik De Haes, who after 14 years as CEO, has decided to move away from day-to-day management of the company to become the Non-executive Chairman of Oxurion. Thomas Clay, the outgoing Chairman of Oxurion, will remain on the Board as a Non-executive Director of the company…

    Patrik De Haes M.D. becomes Non-executive Chairman

    Leuven, BE and Boston, MA, US May 17, 20217:30 AM CETOxurion NV (Euronext Brussels: OXUR), a biopharmaceutical company developing next generation standard of care ophthalmic therapies, with a clinical stage portfolio in retinal vascular disorders, announces in a planned succession, the promotion of Tom Graney, CFA from Chief Financial Officer (CFO) to Chief Executive Officer (CEO) of the company. He takes over from Dr. Patrik De Haes, who after 14 years as CEO, has decided to move away from day-to-day management of the company to become the Non-executive Chairman of Oxurion. Thomas Clay, the outgoing Chairman of Oxurion, will remain on the Board as a Non-executive Director of the company.

    Mr. Graney has extensive capital markets and business development experience in biotech as the CFO of several successful public companies. This includes having raised >$500M in capital for highly innovative companies like Oxurion and completing a number of value creating business development transactions. Tom also has an impressive track record of developing high performing teams and talent everywhere he has worked both in the United States and Europe.

    Tom's transatlantic experience in creating significant company and shareholder value makes him uniquely qualified to lead Oxurion as its next CEO as it moves its highly differentiated assets through clinical development.

    Tom joined Oxurion as CFO in October 2020, and has over 25 years' experience in senior finance, strategy, business development and operational roles including most recently as CFO of Generation Bio (NASDAQ:GBIO), and before that CFO of Vertex Pharmaceuticals (NASDAQ:VRTX), and CFO and Head of Corporate Strategy at Ironwood Pharmaceuticals (NASDAQ:IRWD). Earlier in his career he spent 20 years with Johnson and Johnson, including CFO roles at Ethicon, Tibotec and Janssen. Tom also serves on the board of AC Immune (NASDAQ:ACIU).

    Tom has an MBA in finance, marketing and international business from the Leonard N. Stern School of Business at New York University and a BS in accounting from the University of Delaware. He is also a CFA charterholder.

    Tom Graney, the incoming CEO of Oxurion, said, "I am very excited and honored to become the CEO of Oxurion as we build out our plan to create an important ophthalmic company grounded in exceptional science. I am confident that with THR-149 and THR-687, two highly promising and differentiated new drug candidates, coupled with our extremely talented team, Oxurion has the potential to successfully address a broad range of retinal vascular disorders. This would allow us to generate significant value for patients, payors and shareholders as we look to disrupt and grow the $12 billion market for retinal vascular disorders."

    Patrik De Haes M.D., the incoming Chairman of Oxurion, said, "I am looking forward to supporting Tom and the rest of the Oxurion team in my new role as Chairman as we deliver a number of important clinical development milestones in the months ahead. I am confident that our drug candidates that have the potential to make a significant difference to the lives of the large number of patients with sight threatening disease, who require better treatment options." 

    Thomas Clay, outgoing Chairman of Oxurion, commented, "I would like to thank Patrik for his high level of commitment and leadership to Oxurion over the past 14 years and his desire to continue as Chairman of the company. Oxurion is well placed for future success given its industry-leading pipeline of next generation standard of care ophthalmic therapies and a highly experienced team. I look forward to working with Tom, Patrik and the rest of the board as a Non-executive Director of Oxurion as we look to realize a significant opportunity to bring value to patients and shareholders as we progress the clinical development of THR-149 and THR-687 in diabetic macular edema and other important retinal vascular disorders."

    END

    For further information please contact:

    Oxurion NV

    Wouter Piepers,

    Global Head of Investor Relations

    & Corporate Communications

    Tel: +32 478 33 56 32





     
    EU

    Citigate Dewe Rogerson

    David Dible/ Sylvie Berrebi/Frazer Hall

    Tel: +44 20 7638 9571





     



    US

    Westwicke, an ICR Company

    Christopher Brinzey

    Tel: +1 617 835 9304

    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 retinal vascular disorders including diabetic macular edema (DME), the leading cause of vision loss in diabetic patients worldwide as well as other conditions, including wet age-related macular degeneration (AMD) and retinal vein occlusion (RVO).

    Oxurion is aiming to build the leading global franchise in the treatment of retinal vascular disorders 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 the 40% of DME patients who respond suboptimally 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 multiple injections of THR-149 in DME patients who previously responded suboptimally to anti-VEGF therapy.



    • THR-687 is a pan-RGD integrin antagonist that is initially being developed as a potential first line therapy for DME patients. Positive topline results in a Phase 1 clinical study assessing THR-687 as a treatment for DME were announced in 2020. THR-687 is expected to enter a Phase 2 clinical trial in mid-2021. THR-687, also has the potential to deliver improved treatment outcomes for patients with wet AMD and RVO.



    Oxurion is headquartered in Leuven, Belgium, and is listed on the Euronext Brussels exchange under the symbol OXUR. More information is available at www.oxurion.com.

    Important information about forward-looking statements

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



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    • Reported potent interim immunogenicity results for anti-pTau Alzheimer's vaccine in ongoing Phase 1b/2a study, which support further development into Phase 2/3
    • Initiated first-in-human clinical study for next-generation alpha-synuclein PET diagnostic with results expected in Q3 2021
    • Advanced multiple candidates targeting the NLRP3 inflammasome pathway for CNS and non-CNS indications
    • Strong financial position of CHF 216.1 million in cash ensures the Company is fully financed through at least Q1 2024

    LAUSANNE, Switzerland, April 28, 2021 (GLOBE NEWSWIRE) -- AC Immune SA (NASDAQ:ACIU), a clinical-stage biopharmaceutical company pioneering precision medicine for neurodegenerative diseases, today reported its financial results for the quarter ended…

    • Reported potent interim immunogenicity results for anti-pTau Alzheimer's vaccine in ongoing Phase 1b/2a study, which support further development into Phase 2/3

    • Initiated first-in-human clinical study for next-generation alpha-synuclein PET diagnostic with results expected in Q3 2021
    • Advanced multiple candidates targeting the NLRP3 inflammasome pathway for CNS and non-CNS indications
    • Strong financial position of CHF 216.1 million in cash ensures the Company is fully financed through at least Q1 2024

    LAUSANNE, Switzerland, April 28, 2021 (GLOBE NEWSWIRE) -- AC Immune SA (NASDAQ:ACIU), a clinical-stage biopharmaceutical company pioneering precision medicine for neurodegenerative diseases, today reported its financial results for the quarter ended March 31, 2021. The Company also provided an overview of its recent clinical and corporate highlights and anticipated milestones for 2021.

    Prof. Andrea Pfeifer, CEO of AC Immune SA, commented: "Our clinical and R&D accomplishments over the last quarter serve to strengthen our leadership in precision medicine for neurodegenerative diseases. Encouraging clinical results from both of our Alzheimer's vaccine programs further reinforce our belief that early intervention, and ultimately prevention, using vaccines represents a key strategy in neurodegenerative diseases. To enable this strategy, we are advancing our suite of novel diagnostics, such as our alpha-synuclein imaging agent, which recently entered the clinic in Parkinson's disease. Our vision is to address the heterogeneity of neurodegenerative diseases by pairing earlier, more accurate diagnosis with highly selective treatments that address the right proteinopathy, in the right patient, at the right time."

    Prof. Pfeifer continued: "We are poised to achieve four additional clinical readouts in 2021, as we continue progressing our first-in-class preclinical programs addressing alpha-synuclein, TDP-43, and NLRP3-ASC towards the clinic, driving significant future value creation.

    Q1 2021 Highlights



    Clinical and R&D

    • Reported encouraging top line results from a first-of-its-kind Phase 1b study of anti-Abeta vaccine candidate ACI-24 in people with Down syndrome (DS). These results support further development in Down syndrome-related Alzheimer's disease (AD). AC Immune also reported promising preclinical results for an optimized anti-Abeta vaccine formulation, for which it expects to file an investigational new drug application (IND) in Q4 2021.
    • Reported promising interim Phase 1b/2a results for ACI-35.030, a novel anti-phospho-Tau (pTau) vaccine candidate, showing strong safety and high titers of antigen-specific antibodies in 100% of older patients with early Alzheimer's disease. The study is currently enrolling patients into the highest dose group, with further clinical readouts expected this year.
    • Advanced next-generation alpha-synuclein positron emission tomography (PET) tracer candidate, ACI-12589, into a first-in-human clinical study, with an expected data readout in Q3 2021
    • Identified and characterized the first biologically active small molecule Morphomer™ alpha-synuclein aggregation inhibitors, which significantly decreased alpha-synuclein aggregate formation in cellular assays by interfering with the fibrillation process
    • Reported key advancements for several therapeutic programs targeting the (NOD)-like receptor protein 3 (NLRP3) inflammasome, including small molecule inhibitors, which showed the first evidence of in vivo activity in a model of peripheral inflammation, as well as high-affinity monoclonal antibodies that bind extracellular components of the NLRP3 pathway and inhibit inflammasome-mediated immune response in vitro

    Thought leadership

    • Co-sponsored a virtual Global Down Syndrome Forum that brought together thought leaders on Down syndrome and Down syndrome-related Alzheimer's disease to discuss the unmet need and underlying causes of this important health challenge, as well as the broader implications for clinical development in other Alzheimer's disease populations.
    • Hosted a comprehensive webinar focusing on the Company's proprietary Morphomer™ platform underlying the generation of therapeutic and diagnostic small molecules, which featured presentations and a Q&A session with members of AC Immune's Management and R&D Teams.

    Strengthening of Board

    • Welcomed Dr. Alan Colowick, an experienced biotech and investment executive, to the Company's Board of Directors



    Achieved and Anticipated 2021 milestones

    Clinical Milestones

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

    Preclinical Milestones

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

    Therapeutic and Diagnostic Pipeline Overview

    On March 23, 2021, the Company provided a comprehensive overview highlighting strong progress across its clinical and preclinical development pipeline. This supplemental material can be viewed and downloaded in the investor section of the Company's website.

    Analysis of Financial Statements for the quarter ended March 31, 2021

    • Cash Position: The Company had a total cash balance of CHF 216.1 million, composed of CHF 151.1 million in cash and cash equivalents and CHF 65 million in short-term financial assets. This compares to a total cash balance of CHF 225.9 million as of December 31, 2020. The Company's cash balance provides enough capital resources to progress through at least Q1 2024 without potential incoming milestone payments.
    • Contract Revenues: The Company did not record contract revenues for the three months ended March 31, 2021, a decrease of CHF 12.3 million from the comparable period. The decrease is predominantly related to a CHF 10 million milestone payment as well as CHF 2.1 million in R&D activities recognized in 2020, which did not repeat.
    • R&D Expenditures: R&D expenses decreased by CHF 1.9 million for the three months ended March 31, 2021 to CHF 13.3 million.
      • Discovery and preclinical expenses (+1.2 million): The Company increased expenditures across a variety of its discovery and preclinical programs. These include investments to advance the optimized formulation of our ACI-24 vaccine, the expansion of our Morphomer™ Tau program into NeuroOrphan indications and various other investments across our programs.
      • Clinical expenses (-4.1 million): The Company decreased expenditures across multiple clinical programs, as certain clinical activities completed or incurred significant scaling up in the prior period. For example, the Company completed its clinical activities to complete the Phase 1 trial of our Morphomer™ Tau asset in partnership with Lilly. Additionally, the Company incurred less expense for ACI-24 for DS-related AD as a result of prior period scaling up activities for a Phase 2 clinical trial which were not repeated in the current period.
      • Salary- and benefit-related costs (+1.1 million): The Company's salary- and benefit-related costs increased primarily due to the internal reallocation of certain employees' salaries and annualization of 2020 hires and increases in share-based compensation
    • G&A Expenditures: For the three months ended March 31, 2021, G&A decreased by CHF 0.2 million to 4.3 million. This decrease is predominantly related to the internal reallocation of certain employees' salaries.
    • Other Operating Income: The Company recognized CHF 0.4 million in grant income for R&D activities performed under our MJFF and Target ALS grants, an increase of CHF 0.3 million compared to the prior period
    • IFRS Loss for the Period: The Company reported a net loss after taxes of CHF 16.7 million for the three months ended March 31, 2021, compared with net loss of CHF 7.7 million for the comparable period in 2020

    2021 Financial Guidance 

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

    About AC Immune SA

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

    For further information, please contact:

    Head of Investor Relations and

    Corporate Communications

    Joshua Drumm, Ph.D.

    AC Immune

    Phone : +1 917 809 0814

    Email:

    U.S. Media

    Katie Gallagher

    LaVoie Health Science

    Phone: +1 617 792 3937

    Email:



      
     European Investors & Media

    Chris Maggos

    LifeSci Advisors

    Phone : +41 79 367 6254

    Email :

    Forward-looking statements

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





    Balance Sheets


    (In CHF thousands)

     As of March 31, 2021 As of December 31, 2020
    ASSETS   
    Non-current assets   
    Property, plant and equipment4,896 4,416
    Right-of-use assets2,147 2,223
    Long-term accrued income93 
    Long-term financial assets334 334
    Total non-current assets7,470 6,973
    Current assets   
    Prepaid expenses3,330 3,954
    Short-term accrued income688 1,591
    Other current receivables379 329
    Short-term financial assets65,000 65,000
    Cash and cash equivalents151,092 160,893
    Total current assets220,489 231,767
    Total assets 227,959 238,740
        
    SHAREHOLDERS' EQUITY AND LIABILITIES   
    Shareholders' equity   
    Share capital1,539 1,538
    Share premium354,736 346,890
    Treasury shares(85) (100)
    Accumulated losses(148,774) (132,850)
    Total shareholders' equity207,416 215,478
        
    Non-current liabilities   
    Long-term deferred income93 
    Long-term lease liabilities1,706 1,780
    Net employee defined-benefit liabilities7,619 7,464
    Total non-current liabilities9,418 9,244
        
    Current liabilities   
    Trade and other payables370 2,184
    Accrued expenses9,734 11,085
    Short-term deferred income580 306
    Short-term lease liabilities441 443
    Total current liabilities11,125 14,018
    Total liabilities20,543 23,262
    Total shareholders' equity and liabilities227,959 238,740







    Statements of Income/(Loss)


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

     For the Three Months

    Ended March 31,
     2021 2020
    Revenue   
    Contract revenue 12,281
    Total revenue 12,281
        
    Operating expenses   
    Research & development expenses(13,329) (15,209)
    General & administrative expenses(4,338) (4,504)
    Other operating income/(expense)416 130
    Total operating expenses(17,251) (19,583)
    Operating loss(17,251) (7,302)
        
    Financial income 59
    Financial expense(26) (57)
    Exchange differences543 (389)
    Finance result, net517 (387)
    Loss before tax(16,734) (7,689)
    Income tax expense 
    Loss for the period(16,734) (7,689)
    Loss per share:   
    Basic and diluted loss for the period attributable to equity holders(0.23) (0.11)

    Statements of Comprehensive Income/(Loss)

    (In CHF thousands)

     For the Three Months

    Ended March 31,
     2021 2020
    Loss for the period        (16,734) (7,689)
    Other comprehensive 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) 
    Total comprehensive loss, net of tax(16,734) (7,689)





    Reconciliation of loss to adjusted loss and


    loss per share to adjusted loss per share

      For the Three Months

    Ended March 31,
    In CHF thousands, except for share and per share data 2021 2020
    Loss (16,734) (7,689)
    Adjustments    
    Non-cash share-based payments1 857 852
    Foreign currency (gains)/losses2 (621) 454
    Adjusted Loss (16,498) (6,383)
         
    Loss per share – basic (0.23) (0.11)
    Loss per share – diluted (0.23) (0.11)
    Adjustment to loss per share – basic 0.00 0.02
    Adjustment to loss per share – diluted 0.00 0.02
    Adjusted loss per share – basic (0.23) (0.09)
    Adjusted loss per share – diluted (0.23) (0.09)
    Weighted-average number of shares outstanding Adjusted loss –basic 72,305,949 71,864,213
    Weighted-average number of shares outstanding Adjusted loss –diluted 72,305,949 71,882,607



    1Reflects non-cash expenses associated with share-based compensation for equity awards issued to Directors, Management and employees of the Company. This expense reflects the awards' fair value recognized for the portion of the equity award which is vesting over the period.
    2Reflects foreign currency re-measurement gains and losses for the period, predominantly impacted by the change in the exchange rate between the US Dollar and Euro with the Swiss Franc.

    Adjustments for the three months ended March 31, 2021 and March 31, 2020 decreased net loss by CHF 0.2 million and CHF 1.3 million, respectively. The Company recorded CHF 0.9 million for share-based compensation expenses, respectively. There were foreign currency re-measurement gains of CHF 0.6 million compared to foreign currency re-measurement losses of CHF 0.5 million, respectively, primarily related to a favorable movement in the USD-CHF exchange rate during the period as well as the non-repetition of a CHF 0.1 million loss on a forward contract. 



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

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

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

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

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

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

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

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

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

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

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

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

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

    About AC Immune SA

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

    For further information, please contact:

    Head of Investor Relations

    Joshua Drumm, Ph.D.

    AC Immune

    Phone: +1 917 809 0814

    Email:



    US Media

    Katie Gallagher

    LaVoie Health Science

    Phone: +1 617 792 3937

    Email:



     European Investors & Media

    Chris Maggos

    LifeSci Advisors

    Phone: +41 79 367 6254

    Email:



    Forward looking statements

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



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

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

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

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

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

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

    Key highlights from the event:

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

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

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

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

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

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

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

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

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

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

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

    About AC Immune SA

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

    For further information, please contact:

    Head of Investor Relations

    Joshua Drumm, Ph.D.

    AC Immune

    Phone: +1 917 809 0814

    Email:

    US Media

    Katie Gallagher

    LaVoie Health Science

    Phone: +1 617 792 3937

    Email:

      
     European Investors & Media

    Chris Maggos

    LifeSci Advisors

    Phone: +41 79 367 6254

    Email:

    Forward looking statements

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



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