GlobeNewswire Inc | Nov 8, 2021 07:00AM EST

November 08, 2021

Announced the first positive cognitive results for a Tau-targeting monoclonal antibody in mild-to-moderate Alzheimers disease

Closed its strategic acquisition of an industry-leading Parkinsons disease vaccine and an equity financing led by key investors

Appointed Monica Shaw, M.D., and Prof. Monika Btler, Dr. Oec., to the Board of Directors

Strong financial position of CHF 188.6 million1 ensures the Company is fully financed through at least Q1 2024

LAUSANNE, Switzerland, Nov. 08, 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 September 30, 2021 and provided a corporate update.

Prof. Andrea Pfeifer, CEO of AC Immune SA, commented: AC Immune concluded an exceptional third quarter, highlighted by the acquisition of a clinical -syn vaccine candidate in Parkinsons disease and topline Phase 2 Lauriet data showing that semorinemab was the first Tau antibody candidate to significantly slow cognitive decline in mild-to-moderate Alzheimers disease patients. Our partner Genentech, a member of the Roche Group, will present the topline Lauriet data, later this week at the CTAD 2021 conference, where we will present new clinical data on our p-Tau and Abeta vaccine candidates, ACI-35 and ACI-24, respectively. These achievements show the commitment, progress and breadth of our leadership in discovering and developing impactful therapeutics for neurodegenerative diseases.

1 Total cash position does not include total gross proceeds of USD 30 million received in October 2021 from (i) USD 5 million as part of the Affiris asset acquisition and (ii) USD 25 million as part of a private placement with select group of Affiris investors.

Q3 2021 and Subsequent Highlights

-- Announced the first positive cognitive results for a Tau-targeting monoclonal antibody in Alzheimers disease (AD). Topline data from the Lauriet Phase 2 trial of semorinemab in mild-to-moderate AD showed a statistically significant (p<0.0025) 43.6% reduction at week 49 in cognitive decline vs. placebo as measured by ADAS-Cog11, one of the trials co-primary endpoints. The second co-primary endpoint, ADCS-ADL, was not met. AC Immunes partner Genentech is continuing with the trials open label extension and is scheduled to present the topline data from the Lauriet study at the CTAD (Clinical Trials on Alzheimer's Disease) conference on November 10, 2021, at 10:50am EST. -- Completed an all-stock acquisition of Affiris portfolio of therapeutics targeting alpha-synuclein, notably PD01/ACI-7104, a clinically validated active vaccine candidate that places AC Immune at the forefront of Parkinsons disease drug development. Through this acquisition and a concurrent financing, AC Immune has also strengthened its cash position and added Athos Service GmbH (Strngmann family office), First Capital Partner GmbH (Egger Family Office), and MIG Fonds to its shareholder base. -- Presented the full results from the landmark Phase 1b clinical trial evaluating the wholly-owned anti-Abeta vaccine ACI-24 in subjects with Down syndrome (DS) at the Alzheimers Association International Conference (AAIC) 2021. Data showed that ACI-24 generated immunogenicity along with a positive pharmacodynamic response and a favorable safety and tolerability profile. Based on these results, the Company plans to advance an optimized formulation of ACI-24 into mid-stage clinical testing to treat and prevent the progression of DS-related AD. -- Extended the Companys research partnership with leading scientists at the Center for Neurodegenerative Disease Research at the Perelman School of Medicine at the University of Pennsylvania (Penn). The goal of the collaboration is to further understand the role of distinct pathogenic TDP-43 species in the different TDP-43 proteinopathies. Through the development of novel experimental models, AC Immune and Penn hope to unravel the underlying mechanisms of cell-to-cell transmission of TDP-43 pathology that could provide new therapeutic strategies to target TDP-43-related proteinopathies. -- Welcomed pharmaceutical industry expert Monica Shaw, M.D., and leading Swiss economist Prof. Monika Btler, Dr. Oec., to the Companys Board of Directors. -- Announced that the Swiss Economic Forum (SEF) awarded AC Immune Co-Founder and CEO Prof. Andrea Pfeifer with the SEF.WomenAward for CEO of the Year. This award recognizes women with an excellent entrepreneurial track record, giving greater prominence to role models who can inspire the next generation of businesswomen.

Achieved and Anticipated 2021 milestones

Clinical Milestones

-- ACI-35.030 anti-pTau vaccine: reported Phase 1b/2a interim results in AD patients in Q1 (second highest dose); further Phase 1b/2a interim analysis in Q4 (highest dose) -- JACI-35.054 alternative anti-pTau vaccine: reported a Phase 1b/2a interim analysis in AD patients in Q2 (low dose) -- Alpha-synuclein PET imaging agent: advanced third-generation candidate to first-in-human clinical study in Q1; data to be presented at upcoming scientific meeting -- ACI-24 anti-Abeta vaccine in DS: reported Phase 1b topline results in Q1 -- ACI-24 in AD: reported Phase 2, 12-month interim analysis in Q1; reporting full data set at CTAD in November 2021 -- Semorinemab anti-Tau antibody partnered with Genentech: topline results reported in Q3 -- Small molecule Morphomer Tau aggregation inhibitor program: select NeuroOrphan indication for further development in H2 -- 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 Q4 -- 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 central nervous system 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

Analysis of Financial Statements for the quarter ended September 30, 2021

-- Cash Position: The Company had a total cash balance of CHF 188.6 million, composed of CHF 93.6 million in cash and cash equivalents andCHF 95.0 million in short-term financial assets. This compares to a total cash balance of CHF 225.9 million as of December 31, 2020. The Companys cash balance provides enough capital resources to progress through at least Q1 2024 without consideration of potential incoming milestone payments. -- Contract Revenues: The Company did not record contract revenues for the three months ended September 30, 2021, a decrease of CHF 1.1 million from the comparable period in 2020. The overall decrease is predominantly related to CHF 1.1 million of contract revenue associated with R&D activities in our agreement with Lilly that were recognized in 2020 and did not repeat in the current period. -- R&D Expenditures: R&D expenses decreased by CHF 0.4 million for the three months ended September 30, 2021, to CHF 15.1 million. Discovery and preclinical expenses (-1.7 million): The Company decreased expenditures across a variety of its discovery and preclinical programs. This was predominantly led by a decrease in investment for the research of alpha-synuclein antibodies and other discovery programs.Clinical expenses (+0.6 million): The Company increased expenditures across multiple clinical programs, predominantly for ACI-35-030 driven by R&D cost sharing and increased patient enrollments into the Phase 1b/2a study. This increase was offset as the Company incurred less expense for ACI-24 for AD as the prior six-month safety period completed.Salary- and benefit-related costs (+0.5 million): The Companys salary- and benefit-related costs increased primarily due to the internal reallocation of certain employees salaries and the annualization of 2020 hires. -- G&A Expenditures: For the three months ended September 30, 2021, G&A increased by CHF 0.5 million to CHF 5.4 million. This increase is predominantly related to transaction costs incurred to complete the asset acquisition for Affiris' alpha-synuclein portfolio as well as other administrative items. -- Other Operating Income: The Company recognized CHF 0.3 million in grant income for R&D activities performed under our Michael J. Fox Foundation for Parkinsons Research (MJFF) and Target ALS grants, a decrease of CHF 0.2 million compared to the prior period. -- IFRS Loss for the Period: The Company reported a net loss after taxes of CHF 15.9 million for the three months ended September 30, 2021, compared with a net loss of CHF 19.0 million for the comparable period in 2020.

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 Alzheimers disease, Parkinsons disease, and NeuroOrphan indications driven by misfolded proteins. The Companys two clinically validated technology platforms, SupraAntigen and Morphomer, fuel its broad and diversified pipeline of first- and best-in-class assets, which currently features ten 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.

SupraAntigen is a registered trademark of AC Immune SA in the following territories: AU, EU, CH, GB, JP and RU. Morphomer is a registered trademark ofAC Immune SAin CN, CH, GB, JP, and NO.

For further information, please contact:

Media Relations Investor RelationsSaoyuth Nidh Yves Kremer, Ph.D.AC Immune AC ImmunePhone: +41 21 345 91 34 Phone: +41 21 345 91 90Email: saoyuth.nidh@acimmune.com Email: yves.kremer@acimmune.com

U.S. Media U.S. InvestorsShani Lewis Corey Davis, Ph.D.LaVoie Health Science LifeSci AdvisorsPhone: +1 609 516 5761 Phone: +1 212 915 2577Email: slewis@lavoiehealthscience.com Email: cdavis@lifesciadvisors.com

Forward looking statementsThis 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 Immunes 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 managements 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 Immunes Annual Report on Form 20-F and other filings with theSecurities 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, andAC Immunedoes not undertake any obligation to update them in light of new information, future developments or otherwise, except as may be required under applicable law. All forward-looking statements are qualified in their entirety by this cautionary statement.

Balance Sheets(In CHF thousands)

As of September 30, As of December 31, 2021 2020ASSETS Non-current assets Property, plant and equipment 5,054 4,416 Right-of-use assets 2,572 2,223 Long-term accrued income 31 ? Long-term financial assets 363 334 Total non-current assets 8,020 6,973 Current assets Prepaid expenses 1,935 3,954 Short-term accrued income 92 1,591 Other current receivables 341 329 Derivative financial assets 4,424 ? Short-term financial assets 95,000 65,000 Cash and cash equivalents 93,584 160,893 Total current assets 195,376 231,767 Total assets 203,396 238,740 SHAREHOLDERS? EQUITY AND LIABILITIESShareholders? equity Share capital 1,589 1,538 Share premium 359,421 346,890 Treasury shares (124 ) (100 )Accumulated losses (181,665 ) (132,850 )Total shareholders? equity 179,221 215,478 Non-current liabilities Long-term deferred income 31 ? Long-term lease liabilities 1,992 1,780 Net employee defined-benefit 7,929 7,464 liabilitiesTotal non-current liabilities 9,952 9,244 Current liabilities Trade and other payables 215 2,184 Accrued expenses 13,308 11,085 Short-term deferred income 123 306 Short-term lease liabilities 577 443 Total current liabilities 14,223 14,018 Total liabilities 24,175 23,262 Total shareholders? equity and 203,396 238,740 liabilities

Statements of Income/(Loss)(In CHF thousands, except for per-share data)

For the Three Months For the Nine Months Ended September 30, Ended September 30, 2021 2020 2021 2020 Revenue Contract revenue ? 1,123 ? 14,487 Total revenue ? 1,123 ? 14,487 Operating expenses Research & (15,118 ) (15,518 ) (42,158 ) (43,536 )development expensesGeneral &administrative (5,420 ) (4,892 ) (14,993 ) (13,553 )expensesOther operating 255 482 928 807 income/(expense)Total operating (20,283 ) (19,928 ) (56,223 ) (56,282 )expensesOperating loss (20,283 ) (18,805 ) (56,223 ) (41,795 ) Financial income 4,424 ? 4,424 78 Financial expense (181 ) (46 ) (408 ) (159 )Exchange differences 122 (143 ) 487 (545 )Finance result, net 4,365 (189 ) 4,503 (626 )Loss before tax (15,918 ) (18,994 ) (51,720 ) (42,421 )Income tax expense ? ? ? ? Loss for the period (15,918 ) (18,994 ) (51,720 ) (42,421 )Loss per share: (0.22 ) (0.26 ) (0.71 ) (0.59 )Basic and dilutedloss for the period 72,887,967 71,925,009 72,638,698 71,888,273 attributable toequity holders

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

For the Three Months For the Nine Months Ended September 30, Ended September 30, 2021 2020 2021 2020 Loss for the period (15,918 ) (18,994 ) (51,720 ) (42,421 )Other comprehensive loss that maybe reclassified to income or loss in subsequent periods (net oftax):Currency translation differences ? ? ? ? Other comprehensive loss not tobe reclassified to income or loss in subsequent periods (net oftax):Re-measurement losses ondefined-benefit plans (net of ? ? ? ? tax)Total comprehensive loss, net of (15,918 ) (18,994 ) (51,720 ) (42,421 )tax

Reconciliation of loss to adjusted loss andloss per share to adjusted loss per share

For the Three Months For the Nine Months Ended September 30, Ended September 30,In CHF thousands,except for share and 2021 2020 2021 2020 per share dataLoss (15,918 ) (18,994 ) (51,720 ) (42,421 )Adjustments Non-cash share-based 1,388 1,233 3,081 3,079 payments^1Foreign currency (117 ) 187 (481 ) 686 (gains)/losses^2Change in fair valueof derivative (4,424 ) ? (4,424 ) ? financial assets^3Transaction costs^4 335 ? 745 ? Adjusted Loss (18,736 ) (17,574 ) (52,799 ) (38,656 ) Loss per share ? (0.22 ) (0.26 ) (0.71 ) (0.59 )basic and dilutedAdjustment to lossper share ? basic and (0.04 ) 0.02 (0.02 ) 0.05 dilutedAdjusted loss pershare ? basic and (0.26 ) (0.24 ) (0.73 ) (0.54 )dilutedWeighted-averagenumber of sharesoutstanding Adjusted 72,887,967 71,925,009 72,638,698 71,888,273 loss ? basic anddiluted

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

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

Reflects the change in the fair value of the derivative ^3 financial instruments associated with the convertible notes due to Investors.

Reflects transaction costs associated with our asset acquisition for a portfolio of therapeutics targeting alpha-synuclein.

Adjustments for the three and nine months ended September 30, 2021, increased net loss by CHF 2.8 million and CHF 1.1 million, respectively compared with a decrease to net loss of CHF 1.4 million and CHF 3.8 million for the comparable periods in 2020, respectively. The Company recorded CHF 1.4 million and CHF 3.1 million for share-based compensation ^ expenses, respectively, in each of these periods. There 4 were foreign currency re-measurement gains of CHF 0.1 million and CHF 0.5 million, respectively, primarily related to movement in the USD-CHF exchange rate during the respective periods. The Company also recognized a CHF 4.4 million gain on the change in fair value of the derivative financial assets associated with the convertible notes. This gain did not arise in the comparable prior periods. Finally, the Company incurred CHF 0.3 and CHF 0.7 million in transaction costs associated with its acquisition of a portfolio of therapeutics targeting alpha-synuclein in the three and nine months ended September 30, 2021.