ACIU AC Immune SA

8.98
+0.03  (+0%)
Previous Close 8.95
Open 8.98
52 Week Low 4.07
52 Week High 13
Market Cap $644,236,739
Shares 71,741,285
Float 26,898,670
Enterprise Value $358,651,857
Volume 220,156
Av. Daily Volume 1,262,868
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Upcoming Catalysts

Drug Stage Catalyst Date
Semorinemab (Anti-Tau RO7105705)
Alzheimer’s disease
Phase 2
Phase 2
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ACI-35.030
Alzheimer’s Disease
Phase 1/2
Phase 1/2
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ACI-3024
Alzheimer’s disease
Phase 1
Phase 1
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ACI-24
Alzheimer’s disease (AD)
Phase 2
Phase 2
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Drug Pipeline

Drug Stage Notes
MTAU9937A
Alzheimer’s disease
Phase 2
Phase 2
Phase 2 trial initiation announced February 20, 2019.
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. LAUSANNE, Switzerland, Sept. 11, 2020 (GLOBE NEWSWIRE) -- AC Immune SA (NASDAQ:ACIU), a Swiss-based, clinical-stage biopharmaceutical company with a broad pipeline focused on neurodegenerative diseases, today announced that it will showcase recent progress in its clinical programs targeting Tau for neurodegenerative diseases at the upcoming H.C. Wainwright 22nd Annual Global Investment Conference.

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

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

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

    H.C. Wainwright 22nd Annual Global Investment Conference

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

    Format: Virtual Presentation followed by Q&A

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

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

    About AC Immune SA

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

    For further information, please contact:

    Head of Investor Relations

    Joshua Drumm, Ph.D.

    AC Immune

    Phone: +1 917 809 0814

    Email:



    US Media

    Katie Gallagher

    LaVoie Health Science

    Phone: +1 617 792 3937

    Email:



    Global Head of Communications

    Judith Moore

    AC Immune

    Phone: +41 79 826 63 82

    Email:



    European Investors & Media

    Chris Maggos

    LifeSci Advisors

    Phone: +41 79 367 6254

    Email:

    Forward looking statements

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

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

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

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

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

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

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

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

    Q2 2020 Research & Development Highlights:

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

    Update on Covid-19

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

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

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

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

    About AC Immune SA

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

    For further information, please contact:

    Head of Investor Relations

    Joshua Drumm, Ph.D.

    AC Immune

    Phone: +1 917 809 0814

    Email:

    US Media

    Katie Gallagher

    LaVoieHealthScience

    Phone: +1 617 792 3937

    Email:



    Global Head of Communications

    Judith Moore

    AC Immune

    Phone: +41 79 826 63 82

    Email:

    European Investors & Media

    Chris Maggos

    LifeSci Advisors

    Phone: +41 79 367 6254

    Email:

    Forward looking statements

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

    Balance Sheets

    (in CHF thousands)

     As of June 30,

    2020
     As of December 31,

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



    Statements of Income/(Loss)

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

     
     For the Three Months

    Ended June 30,
      For the Six Months

    Ended June 30,


     2020  2019   2020

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



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

    ended June 30,


     For the Six Months

    ended June 30,


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



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

    Ended June 30,
    For the Six Months

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



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

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

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

    The only TDP-43 antibody with reported in vivo activity

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

    Advancing the anti-TDP-43…

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

    The only TDP-43 antibody with reported in vivo activity

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

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

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

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

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

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

    About AC Immune SA

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

    For further information, please contact:

    Head of Investor Relations

    Joshua Drumm, Ph.D.

    AC Immune

    Phone: +1 917 809 0814

    Email:

    US Media

    Katie Gallagher

    LaVoieHealthScience

    Phone: +1 617 792 3937

    Email:

      
    Global Head of Communications

    Judith Moore

    AC Immune

    Phone: +41 79 826 63 82

    Email:

    European Investors & Media

    Chris Maggos

    LifeSci Advisors

    Phone: +41 79 367 6254

    Email:

      

    Forward looking statements

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

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

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

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

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

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



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



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

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

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

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

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

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

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

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

    About AC Immune's alpha-synuclein programs

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

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

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

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

    About AC Immune SA

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

    For further information, please contact:

    Head of Investor Relations

    Joshua Drumm, Ph.D.

    AC Immune

    Phone: +1 917 809 0814

    Email:

     
    US Media

    Katie Gallagher

    LaVoieHealthScience

    Phone: +1 617 792 3937

    Email:

     
    Global Head of Communications

    Judith Moore

    AC Immune

    Phone: +41 79 826 63 82

    Email:



    European Investors & Media

    Chris Maggos

    LifeSci Advisors

    Phone: +41 79 367 6254

    Email:



    Forward looking statements

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

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

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

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

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

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

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

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

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

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

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

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

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

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

    About AC Immune SA

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

    For further information, please contact:

    Head of Investor Relations

    Joshua Drumm, Ph.D.

    AC Immune

    Phone: +1 917 809 0814

    Email:

    US Media

    Katie Gallagher

    LaVoieHealthScience

    Phone: +1 617 792 3937

    Email:

      
    Global Head of Communications

    Judith Moore

    AC Immune

    Phone: +41 79 826 63 82

    Email:

    European Investors & Media

    Chris Maggos

    LifeSci Advisors

    Phone: +41 79 367 6254

    Email:

    Forward looking statements

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

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