Annonce • Aug 13
Ac Immune Receives Fda Fast Track Designation and Ind Clearance for Anti-Alpha-Synuclein Active Immunotherapy Aci-7104 to Treat Early Parkinson’S Disease AC Immune SA received Fast Track designation and clearance of its Investigational New Drug (IND) application from the U.S. Food and Drug Administration (FDA) for its wholly owned anti-alpha-synuclein (a-syn) active immunotherapy candidate, ACI-7104, for the treatment of early-stage Parkinson’s disease (PD). ACI-7104 is designed to induce a-syn-specific antibodies, preferentially recognizing aggregated a-syn species that are toxic to neurons. The candidate is currently being investigated in the VacSYn Phase 2 trial, an adaptive, biomarker-based study in patients with early-stage Parkinson’s disease, with final Part 1 week-100 results on track to be announced in H2. FDA Fast Track designation reflects the early interim Phase 2 data demonstrating safety, tolerability and immunogenicity, and providing first signals that targeting underlying a-syn pathology with an active immunotherapy could potentially impact PD. The interim results, reported for Part 1 of the study at 76 weeks, successfully demonstrated ACI-7104 was safe and well tolerated, with no clinically relevant safety issues being reported. Targets were also met for immunogenicity with a 100% responder rate. AC Immune recently announced a $4 million research grant from the Vijay and Marie Goradia Charitable Foundation to support the extension of Part 1 of the VacSYn trial, enabling the assessment of long-term safety and efficacy of ACI-7104 for an additional two years. ACI-7104 is an optimized formulation of AC Immune’s anti-a-syn predecessor active immunotherapy which generated an antibody response against pathological oligomeric a-syn to inhibit spreading and downstream neurodegeneration in early Parkinson’s disease. The accumulation of alpha-synuclein protein aggregates has been shown to cause inflammatory stress in cells and contributes to the degeneration of neurons in the brain, linking it to the development of neurodegenerative diseases such as Parkinson’s Disease. New Risk • Aug 09
New major risk - Revenue and earnings growth Earnings are forecast to decline by an average of 10% per year for the foreseeable future. This is considered a major risk. Ultimately, shareholders want to see a good return on their investment and that generally comes from sharing in the company's profits. If profits are expected to decline, then in most cases the share price will decline over time as well. In addition, if the company pays dividends it will also likely need to reduce or cut them, striking a dual blow to total shareholder returns. Currently, the following risks have been identified for the company: Major Risk Earnings are forecast to decline by an average of 10% per year for the foreseeable future. Minor Risks Less than 1 year of cash runway based on current free cash flow (-CHF70m). Currently unprofitable and not forecast to become profitable over next 3 years (CHF37m net loss in 3 years). Share price has been volatile over the past 3 months (10.0% average weekly change). Reported Earnings • Aug 05
Second quarter 2026 earnings released: EPS: CHF0.019 (vs CHF0.21 loss in 2Q 2025) Second quarter 2026 results: EPS: CHF0.019 (up from CHF0.21 loss in 2Q 2025). Revenue: CHF15.1m (up CHF13.8m from 2Q 2025). Net income: CHF1.87m (up CHF23.1m from 2Q 2025). Profit margin: 12% (up from net loss in 2Q 2025). The move to profitability was primarily driven by higher revenue. Revenue is forecast to grow 20% p.a. on average during the next 3 years, compared to a 15% growth forecast for the Biotechs industry in Europe. Over the last 3 years on average, earnings per share has increased by 9% per year but the company’s share price has fallen by 12% per year, which means it is significantly lagging earnings. New Risk • Aug 05
New minor risk - Financial position The company has less than a year of cash runway based on its current free cash flow. Free cash flow: -CHF70m This is considered a minor risk. With less than a year's worth of cash, the company will need to raise capital or take on debt unless its cash flows improve. This would dilute existing shareholders or increase balance sheet risk. Currently, the following risks have been identified for the company: Minor Risks Less than 1 year of cash runway based on current free cash flow (-CHF70m). Share price has been volatile over the past 3 months (9.9% average weekly change). Annonce • Jul 01
Ac Immune Sa Reports Interim 12-Month Data from Phase 1B/2 Abate Trial of Aci-24 in Prodromal Alzheimer's Disease AC Immune SA issued a press release announcing 12-month data from Phase 1b/2 ABATE Trial of ACI-24 in Prodromal Alzheimer's Disease. ACI-24 anti-Abeta active immunotherapy generally safe and well tolerated in first three Alzheimer's disease (AD) cohorts in ABATE. Anti-Abeta antibody dose-response demonstrated with antibodies detected at all dose levels in cohorts AD1-3. Ongoing AD4 cohort includes additional adjuvant designed to enhance ACI-24 responses. Interim data from the first three cohorts (AD1, AD2 & AD3) of 74 patients with prodromal Alzheimer's disease (AD) in the Phase 1b/2 ABATE trial following 12 months of treatment with ACI-24 anti-amyloid beta (Abeta) active immunotherapy. In the trial to date, ACI-24 has been generally safe and well tolerated, with no evidence of amyloid-related imaging abnormalities-edema (ARIA-E). Anti-Abeta antibody responses were detected at every dose level with a dose response. Enhancing ACI-24 with an additional adjuvant to boost immunogenicity while the ABATE trial was ongoing. This is currently being tested in the recently initiated ABATE Cohort AD4. ACI-24 is AC Immune's anti-Abeta active immunotherapy candidate. ABATE is a randomized, double-blind, placebo-controlled Phase 1b/2 trial of ACI-24 in prodromal AD and in adults with Down syndrome (DS) where recruitment of participants into the third cohort, DS3, has been concluded (NCT05462106). Enrolled patients in the AD cohorts are required to have a diagnosis of prodromal AD: MCI due to AD according to the National Institute on Aging Alzheimer's Association (NIA-AA) criteria, and a PET scan at screening must be consistent with the presence of amyloid pathology. Following multiple data safety monitoring board (DSMB) reviews, no safety concerns have been raised to date, with no evidence of amyloid-related imaging abnormalities (ARIA), consistent with previous results. AC Immune has an exclusive, worldwide option and license agreement with Takeda on anti-Abeta active immunotherapies, including ACI-24. Under the terms of the agreement, AC Immune received an upfront payment of $100 million and a milestone of $12 million on dosing of the first patients in Cohort AD4. AC Immune is eligible to receive an option exercise fee and additional potential development, commercial and sales-based milestones of up to approximately $2.1 billion. Upon commercialization, AC Immune will be entitled to receive tiered double-digit royalties on worldwide net sales. AC Immune is responsible for conducting the ABATE trial. Following the potential option exercise, Takeda would conduct and fund all further clinical development and be responsible for all global regulatory activities as well as worldwide commercialization. Annonce • May 17
AC Immune SA Announces Retirement of Andrea Pfeifer as CEO The Davos Alzheimer’s Collaborative congratulates DAC member and dear colleague Dr Andrea Pfeifer, who is retiring as CEO of AC Immune, on her distinguished career and contributions to advancing global policies, disease-modifying therapies, and precision prevention of Alzheimer’s disease (AD) and other neurodegenerative diseases. Dr Pfeifer has played a leading role in defining global clinical development strategies linked to the prevention and disease modification of both Alzheimer’s and Parkinson’s diseases. She co-founded AC Immune in 2003 as CEO and has provided 23 years of visionary leadership, shaping the company into a resilient, innovation-driven, pioneering clinical-stage biopharmaceutical company developing precision therapeutics for neurodegenerative diseases. She remains a key member of DAC and the Global CEO Initiative on Alzheimer’s Disease (CEOi) and is Co-founder and Chairwoman of the Global BHP BrainTrust, which is focused on prevention and women’s brain health. Annonce • May 14
AC Immune SA, Annual General Meeting, Jun 11, 2026 AC Immune SA, Annual General Meeting, Jun 11, 2026. Annonce • May 13
AC Immune SA Announces Executive Changes AC Immune SA announces that Co-founder and CEO, Dr Andrea Pfeifer, to retire after a distinguished 23-year tenure. Dr Andrea Pfeifer will be engaged as an Advisor to facilitate the transition and will be appointed as Honorary Chair of the Board of Directors and Co-Chair of the Scientific Advisory Board. Dr Pfeifer co-founded AC Immune SA in 2003 as CEO and has shaped the company into a resilient, innovation-driven, pioneering clinical-stage biopharmaceutical company developing precision therapeutics for neurodegenerative diseases. Dr Pfeifer listed the company on the Nasdaq stock exchange in 2016. She has been widely recognized for her leadership in defining global clinical development strategies linked to the prevention and disease modification of both Alzheimer’s and Parkinson’s diseases. Annonce • May 02
AC Immune SA Initiates Final Cohort in Ongoing Phase 1b/2 ABATE Trial of Anti-Abeta Active Immunotherapy to Treat Alzheimer's Disease AC Immune SA dosed the first patients in Cohort AD4 in the ongoing Phase 1b/2 ABATE trial. Treatment of first patient in Cohort AD4 in ABATE trial triggers $12 million milestone payment. ABATE is assessing ACI-24 in subjects with prodromal AD and in adults with Down syndrome (DS). AD4 includes subjects with prodromal AD. ACI-24 is an anti-Abeta active immunotherapy candidate designed to induce a robust antibody response against the toxic forms of Abeta believed to drive plaque formation and AD progression. By inducing plaque clearance and efficiently inhibiting plaque formation in the brain, ACI-24 has the potential to delay or slow AD progression. ACI-24 is being investigated in the ongoing ABATE randomized, double-blind, placebo-controlled Phase 1b/2 trial to assess its safety, tolerability, immunogenicity and pharmacodynamic effects. Data so far show that ACI-24 is generally safe and well tolerated, and that it has generated anti-Abeta antibody responses at all tested doses. Cohorts AD1, AD2 and AD3 enrolled a total of 74 patients who received ACI-24 at escalating dose levels. The 12-month data readouts from Cohorts AD1, AD2 and AD3 are expected later in Second Quarter 2026. Cohort AD4 will include an initial group of 36 patients treated for 12 months, with follow-up of 6 months, significantly expanding the safety and biomarker efficacy data set. A subsequent expansion of the AD4 cohort could potentially see the total number of subjects reach approximately 112 patients. AC Immune is responsible for conducting the ABATE trial. Following the potential option exercise, Takeda would conduct and fund all further clinical development and be responsible for all global regulatory activities as well as worldwide commercialization. Under the terms of the agreement with Takeda, AC Immune received an upfront payment of $100 million and is eligible to receive an option exercise fee and additional potential development, commercial and sales-based milestones of up to approximately $2,100 million, if all related milestones are achieved over the course of the agreement. Upon commercialization, AC Immune will be entitled to receive tiered double-digit royalties on worldwide net sales. The ABATE randomized, double-blind, placebo-controlled Phase 1b/2 trial of ACI-24 for treatment of Alzheimer’s disease (AD) continues fully blinded (NCT05462106). Enrolled patients are required to have a diagnosis of prodromal AD: MCI due to AD according to the National Institute on Aging Alzheimer’s Association (NIA-AA) criteria, and a PET scan at screening must be consistent with the presence of amyloid pathology. Patients will be randomized to one of several doses of ACI-24 or placebo. Following multiple data safety monitoring board (DSMB) reviews, no safety concerns have been raised to date, consistent with previous results. Very encouraging immunogenicity has been shown with clear evidence of anti-Abeta antibody responses against toxic Abeta species observed in the blinded data. Annonce • Mar 20
Ac Immune Sa Presents First in Vivo Images of Brain Tdp-43 Pathology from Phase 1 Trial of Pet Tracer Aci-19626 AC Immune SA, a clinical-stage biopharmaceutical company pioneering precision therapeutics for neurodegenerative diseases, announced the presentation of Phase 1 data including the first in vivo images of TDP-43 pathology in the human brain, detected using its first-in-class positron emission tomography (PET) tracer ACI-19626, at the International Conference on Alzheimer’s and Parkinson’s Disease (AD/PD 2026). Initial data from the Phase 1 trial support ACI-19626’s potential to detect pathological TDP-43 in the brains of patients with TDP-43 proteinopathies, enabling a precision medicine approach to multiple neurodegenerative diseases. Specifically, PET scans with ACI-19626 showed that tracer uptake was significantly higher in key regions of the brain in patients with frontotemporal dementia (FTD) due to mutated C9orf72 than in the brains of healthy subjects. Regions with higher tracer uptake included subcortical and cortical regions of the brain where TDP-43 pathology is expected based on post-mortem neuropathology studies. ACI-19626 showed good safety and tolerability, a dosimetry profile within accepted limits, and rapid brain uptake and washout, indicating a pharmacokinetic (PK) profile suitable for human brain imaging and potentially pharmacodynamic analysis of therapeutics targeting TDP-43 pathology. TDP-43 is the main component in inclusions found in the brains of people with FTD, amyotrophic lateral sclerosis (ALS) and limbic-predominant age-related TDP-43 encephalopathy (LATE), as well as a co-pathology in Alzheimer’s disease (AD) and Parkinson’s disease (PD). These conditions share many of the same clinical signs and symptoms, making differential diagnosis a difficult and lengthy process in the absence of reliable biomarkers. The Phase 1, first-in-human trial (Clinicaltrials.gov: NCT06891716) is in two parts. Part 1 is investigating ACI-19626 in healthy volunteers and patients with genetic FTD and is expected to be completed in First Half 2026. The Part 2 expansion may include up to 30 patients with FTD, ALS or LATE. Exploration of ACI-19626 binding in additional patient populations including ALS is ongoing. Annonce • Feb 25
AC Immune Initiates Phase 1 Clinical Trial of NLRP3 Inhibitor AC Immune SA announced that the first participant has been dosed in a Phase 1 clinical trial of ACI-19764, an orally administered small molecule inhibitor of the NLRP3 inflammasome. Targeting the NLRP3 inflammaome provides an opportunity to reduce the chronic inflammation thought to be associated with disease progression in multiple inflammatory disorders, metabolic diseases, and neurological diseases, including Alzheimer's disease (AD), Parkinson's disease (PD), amyotrophic lateral sclerosis (ALS) and frontotemporal dementia. The Phase 1 trial will investigate the safety, tolerability, pharmacokinetics, and pharmacodynamics of ACI-19764 in healthy volunteers. The study is dividend into two parts. Part A will evaluate single ascending doses while Part B will examine multiple ascending doses. The trial is being conducted in Europe. Primary outcome measures include the safety and tolerability of ACI-19764., as well as its pharmacokinetics in plasma and cerebrospinal fluid. A secondary outcome measure will assess target engagement (inhibition of IL-1) and exploratory endpoints will include the influence of ACI-19764 on fluid biomarkers of the immune system, among others. Initial data from the Phase 1 trial are expected in the second half of 2026. ACI-19764 has demonstrated a highly competitive profile in extensive preclinical studies, with optimal brain penetrant in animal models, high potency and selectivity in assays including whole human blood and in several in vivo models, and an excellent safety and tolerability profile. In a mouse model of diet-induced obesity (DIO), ACI-19764 showed excellent weight control both alone and in combination with semaglutide, as well as reductions in activation of both microglia and astrocytes. These preclinical data position ACI-19764 competitively among the best-in-class NLRP3 inhibitors for CNS indications. ACI-19764 is an orally available, highly brain penetrant, small molecule drug candidate which specifically inhibits the NLRP3 inhibitor. Annonce • Feb 18
AC Immune SA to Report Q4, 2025 Results on Mar 12, 2026 AC Immune SA announced that they will report Q4, 2025 results on Mar 12, 2026 Annonce • Oct 29
AC Immune SA Announces Advisory Board Changes AC Immune SA announced the appointment of Prof. Catherine Mummery, a deeply experienced neurologist and expert in dementia clinical trials, as Chairwoman of its Clinical Advisory Board (CAB). Prof. Mummery leads the cognitive disorders service at the UKs National Hospital for Neurology and Neurosurgery (NHNN), where she has practiced as a consultant neurologist since 2004. She is head of novel therapeutics at the Dementia Research Centre at University College London (UCL), and deputy director for the Leonard Wolfson Experimental Neurology Centre at NHNN, a unit dedicated to early phase trials in neurodegeneration. She has been senior investigator on more than 20 early-stage studies of disease-modifying agents in dementias, including the first-ever clinical trial of a gene silencing therapy targeting Tau to treat Alzheimers disease, as well as trials of AC Immunes anti-pTau active immunotherapy candidate ACI-35.030 (JNJ-2056). The CAB provides AC Immune with strategic clinical development and regulatory advice and members are selected based on their expertise and peer recognition in the field of neurodegeneration. As well as Prof. Mummery, the CAB also includes: Dr. Reisa Sperling, Brigham and Women's Hospital and Massachusetts General Hospital, Boston (US); Dr. Murat Emre, Istanbul Faculty of Medicine, Istanbul University, Istanbul (Turkey); Dr. Lon Schneider, Keck School of Medicine of University of Southern California, Los Angeles, CA (US); Dr. Pierre Tariot, Banner Alzheimers Institute, Phoenix, AZ (US); and Dr. Juan Fortea, Hospital of Sant Pau, Barcelona (Spain). Dr. Kaj Blennow, the previous Chairman, is retiring from the CAB. Annonce • Sep 25
Ac Immune Sa Announces Results from Phase 1B/2A Trial of Anti-Ptau Active Immunotherapy from Ac Immune Sa Published in Ebiomedicine AC Immune SA announced the peer-reviewed publication in eBioMedicine of results from the completed Phase 1b/2a trial of active immunotherapy ACI-35.030's (JNJ-2056) partnered with Janssen Pharmaceuticals Inc., a Johnson & Johnson company. ACI-35.030 generated a rapid, robust and durable polyclonal response against pathological forms of Tau including phosphorylated Tau (pTau) and brain-derived Tau (enriched paired helical filament, ePHF). There were no clinically relevant safety or tolerability observations for either ACI-35.030 or JACI-35.054. The publication is entitled "Safety and immunogenicity of two Tau-targeting active immunotherapies, ACI-35.030 and JACI-35. May4, in participants with early Alzheimer's disease: a Phase 1b/2a, multicentre, double-blind, randomized, placebo-controlled study" and reports the following key findings from the completed trial (NCT04445831): ACI-35.030 is based on AC Immune's proprietary SupraAntigen®? technology which anchors the pTau peptide in a liposome and also incorporates non-Tau T-cell epitopes and adjuvants. JACI-35.074 covalently linked the immunogen to the carrier protein CRM197 and was mixed with adjuvants. Both active immunotherapies used the same target pTau peptide sequence. ACI-35.03 (JNJ-64042056) is an investigational active immunotherapy designed using AC Immune's SupraAntigen®? platform. Its liposomal formulation incorporates a conformationally-constrained, membrane bound target peptide, phosphorylated Tau, in addition to adjuvants and non-Tau T-helper peptides. Immunization with ACI-35.030 has been shown in a recent Phase 1b/2a clinical trial to rapidly elicit antibodies after the first injection against extracellular pathological pTau in 100% of patients with early Alzheimer's disease. Importantly, the antibody response was observed at all tested doses and induced a rapid and sustained response against pathological Tau, while requiring less frequent dosing to maintain titers as compared to monoclonal antibodies. Safety and rapid, durable responses are key advantages of active immunotherapies, which make them particularly well suited to the long-term treatment needed to achieve precision prevention. Annonce • Jun 12
AC Immune SA Announces Executive Changes AC Immune SA announced with immediate effect Dr Günther Staffler, PhD, will be promoted to the interim role of Executive Vice President, Development, and will join the Executive Management Team. In this role he will oversee the development of AC Immune’s active immunotherapies including clinical activities. Dr Staffler joined AC Immune in 2021 from Affiris where he was Chief Technical Officer following senior roles in R&D. He has a strong background in immunotherapy having been responsible for progressing multiple programs from preclinical to clinical development in Central Nervous System indications working on targets including amyloid beta and a-synuclein. Prior to Affiris, he worked at biotech companies in Vienna including Biovertis and Intercell (now vaccine specialist, Valneva). Dr Staffler completed his doctoral thesis in immunology at the Medical University of Vienna. Dr Anke Post, MD, currently Chief Medical Officer, will leave the Company with immediate effect. We thank her for her contributions and wish her well in her future endeavors. Annonce • May 20
AC Immune SA, Annual General Meeting, Jun 19, 2025 AC Immune SA, Annual General Meeting, Jun 19, 2025, at 14:00 W. Europe Standard Time. Location: epfl innovation park, building d, pluton conference room, 1015, lausanne Switzerland Annonce • Nov 14
Ac Immune Reports Positive Interim Results from Phase 2 Trial of Aci-7104.056 Active Immunotherapy in Early Parkinson’S Disease AC Immune SA announced positive interim safety and immunogenicity data from the Phase 2 VacSYn clinical trial evaluating ACI-7104.056, its wholly owned anti-alpha-synuclein (a-syn) active immunotherapy candidate, for the treatment of patients with early Parkinson’s disease (PD). VacSYn is an adaptive, placebo-controlled, and biomarker-based Phase 2 study in patients with early PD, consisting of two parts with a seamless transition. Part 1 includes initial analyses from over 30 patients randomized to receive ACI-7104.56 or placebo at a ratio of 3:1. To date, no clinically relevant safety issues have been reported other than transient injection site reactions (49%) and headaches (18%). Interim results show positive antibody responses were effectively induced against the target antigen at week 6 after 2 immunizations and were strongly boostable. Treatment with ACI-7104.056 induced an increase in anti-a-syn antibodies on average 16-fold higher than the placebo background level after three immunizations. Based on further interim results to be reported in H1 2025 including pharmacodynamic data, AC Immune may decide to initiate Part 2 of VacSYn with up to 150 patients. Patients from Part 2 will also be evaluated for progression of motor and non-motor symptoms of the disease, as well as digital, imaging, and fluid biomarkers. The aim is to establish early proof-of-concept and identification of disease-specific biomarkers for rapid transition into a pivotal study. ACI-7104.056 is an optimized formulation of its clinically validated anti-a-syn predecessor active immunotherapy which generated a target-specific antibody response against pathological oligomeric a-syn to inhibit spreading and downstream neurodegeneration in early Parkinson’s disease. The accumulation of alpha-synuclein protein aggregates has been shown to cause inflammatory stress in cells and contribute to the degeneration of neurons in the brain. It has been known to play a key role in the development of neurodegenerative diseases such as Parkinson’s Disease. Previous clinical studies showed the predecessor candidate produced a strong and boostable antibody response with evidence of target engagement and a signal of clinical efficacy. Board Change • Nov 01
Insufficient new directors No new directors have joined the board in the last 3 years. The company's board is composed of: No new directors. 11 experienced directors. 1 highly experienced director. Independent Vice Chair Monika Butler was the last director to join the board, commencing their role in 2021. The following issues are considered to be risks according to the Simply Wall St Risk Model: Insufficient board refreshment. Breakeven Date Change • Aug 09
No longer forecast to breakeven The 3 analysts covering AC Immune no longer expect the company to break even during the foreseeable future. The company was expected to make a profit of CHF14.4m in 2024. New consensus forecast suggests the company will make a loss of CHF30.3m in 2026. New Risk • Aug 08
New minor risk - Profitability The company is currently unprofitable and not forecast to become profitable over the next 3 years. Trailing 12-month net loss: CHF61m Forecast net loss in 3 years: CHF12m This is considered a minor risk. Companies that are not profitable are more likely to be burning through cash and less likely to be well established. Ultimately, shareholders want to see a good return on their investment and that generally comes from sharing in the company's profits. Without profits, the company is under pressure to grow significantly while potentially having to reduce costs and possibly needing to take on debt or raise capital to remain afloat. Currently, the following risks have been identified for the company: Major Risk Share price has been highly volatile over the past 3 months (15% average weekly change). Minor Risks Currently unprofitable and not forecast to become profitable over next 3 years (CHF12m net loss in 3 years). Shareholders have been diluted in the past year (28% increase in shares outstanding). Annonce • Aug 07
AC Immune SA has filed a Follow-on Equity Offering in the amount of $80 million. AC Immune SA has filed a Follow-on Equity Offering in the amount of $80 million.
Security Name: Common Shares
Security Type: Common Stock
Transaction Features: At the Market Offering New Risk • Jul 10
New major risk - Revenue and earnings growth Earnings are forecast to decline by an average of 23% per year for the foreseeable future. This is considered a major risk. Ultimately, shareholders want to see a good return on their investment and that generally comes from sharing in the company's profits. If profits are expected to decline, then in most cases the share price will decline over time as well. In addition, if the company pays dividends it will also likely need to reduce or cut them, striking a dual blow to total shareholder returns. Currently, the following risks have been identified for the company: Major Risks Share price has been highly volatile over the past 3 months (15% average weekly change). Earnings are forecast to decline by an average of 23% per year for the foreseeable future. Minor Risk Shareholders have been diluted in the past year (21% increase in shares outstanding). Annonce • May 24
AC Immune SA, Annual General Meeting, Jun 20, 2024 AC Immune SA, Annual General Meeting, Jun 20, 2024, at 14:30 W. Europe Standard Time. Location: epfl innovation park, building f, ground floor, confrence room luna, 1015, lausanne Switzerland New Risk • May 21
New minor risk - Profitability The company is currently unprofitable and not forecast to become profitable over the next 3 years. Trailing 12-month net loss: CHF55m Forecast net loss in 3 years: CHF20m This is considered a minor risk. Companies that are not profitable are more likely to be burning through cash and less likely to be well established. Ultimately, shareholders want to see a good return on their investment and that generally comes from sharing in the company's profits. Without profits, the company is under pressure to grow significantly while potentially having to reduce costs and possibly needing to take on debt or raise capital to remain afloat. Currently, the following risks have been identified for the company: Major Risk Share price has been highly volatile over the past 3 months (14% average weekly change). Minor Risks Currently unprofitable and not forecast to become profitable over next 3 years (CHF20m net loss in 3 years). Shareholders have been diluted in the past year (21% increase in shares outstanding). Breakeven Date Change • May 15
Forecast to breakeven in 2025 The 3 analysts covering AC Immune expect the company to break even for the first time. New consensus forecast suggests the company will make a profit of CHF7.01m in 2025. Average annual earnings growth of 54% is required to achieve expected profit on schedule. Breakeven Date Change • Apr 17
Forecast to breakeven in 2026 The 3 analysts covering AC Immune expect the company to break even for the first time. New consensus forecast suggests losses will reduce by 34% per year to 2025. The company is expected to make a profit of CHF2.68m in 2026. Average annual earnings growth of 65% is required to achieve expected profit on schedule. Reported Earnings • Mar 15
Full year 2023 earnings released: CHF0.64 loss per share (vs CHF0.85 loss in FY 2022) Full year 2023 results: CHF0.64 loss per share (improved from CHF0.85 loss in FY 2022). Revenue: CHF14.8m (up 276% from FY 2022). Net loss: CHF54.2m (loss narrowed 23% from FY 2022). Revenue is forecast to grow 40% p.a. on average during the next 3 years, compared to a 13% growth forecast for the Biotechs industry in Germany. Over the last 3 years on average, earnings per share has increased by 10% per year but the company’s share price has fallen by 22% per year, which means it is significantly lagging earnings. New Risk • Dec 20
New minor risk - Shareholder dilution The company's shareholders have been diluted in the past year. Increase in shares outstanding: 28% This is considered a minor risk. Shareholder dilution occurs when there is an increase in the number of shares on issue that is not proportionally distributed between all shareholders. Often due to the company raising equity capital or some options being converted into stock. All else being equal, if there are more shares outstanding then each existing share will be entitled to a lower proportion of the company's total earnings, thus reducing earnings per share (EPS). While dilution might not always result in lower EPS (like if the company is using the capital to fund an EPS accretive acquisition) in a lot cases it does, along with lower dividends per share and less voting power at shareholder meetings. Currently, the following risks have been identified for the company: Major Risks Share price has been highly volatile over the past 3 months (13% average weekly change). Revenue is less than US$1m (CHF1.0k revenue, or US$1.2k). Minor Risks Currently unprofitable and not forecast to become profitable over next 3 years (CHF38m net loss in 3 years). Shareholders have been diluted in the past year (28% increase in shares outstanding). Annonce • Dec 17
AC Immune SA has completed a Follow-on Equity Offering in the amount of $50.05 million. AC Immune SA has completed a Follow-on Equity Offering in the amount of $50.05 million.
Security Name: Common Shares
Security Type: Common Stock
Securities Offered: 14,300,000
Price\Range: $3.5
Discount Per Security: $0.21 New Risk • Nov 06
New major risk - Revenue and earnings growth Earnings are forecast to decline by an average of 18% per year for the foreseeable future. This is considered a major risk. Ultimately, shareholders want to see a good return on their investment and that generally comes from sharing in the company's profits. If profits are expected to decline, then in most cases the share price will decline over time as well. In addition, if the company pays dividends it will also likely need to reduce or cut them, striking a dual blow to total shareholder returns. Currently, the following risks have been identified for the company: Major Risks Share price has been highly volatile over the past 3 months (11% average weekly change). Earnings are forecast to decline by an average of 18% per year for the foreseeable future. Revenue is less than US$1m (CHF1.0k revenue, or US$1.1k). Minor Risk Currently unprofitable and not forecast to become profitable over next 3 years (CHF92m net loss in 3 years). Annonce • Jul 27
AC Immune SA Announces Executive Changes On July 26, 2023, AC Immune SA announced the appointment of Nuno Mendonça, MD. Effective October 1, 2023, Dr. Mendonça will join the Company as Chief Medical Officer and be appointed to the Executive Committee. Johannes Streffer, MD, currently Chief Medical Officer, will leave at the end of September. Annonce • Jun 28
AC Immune SA Receives FDA Fast Track Designation for Anti-Amyloid-Beta Active Immunotherapy, ACI-24 060, to Treat Alzheimer's Disease AC Immune SA announced that it has received Fast Track designation from the U.S. Food and Drug Administration (FDA) for its wholly-owned anti-amyloid beta (Abeta) active immunotherapy (vaccine)-candidate, ACI-24.060, for treatment of Alzheimer's disease. This follows FDA clearance of the Investigational New Drug (IND) application enabling expansion to the USA of the ongoing Phase 1b/2 ABATE study of ACI- 24.060 in patients with AD and individuals with DS. Furthermore, the first individual with DS has been dosed in ABATE. This regulatory progress underscores the attraction of an active immunotherapy targeting toxic species of Abeta. By inducing a polyclonal response including antibodies against both oligomeric Abeta and pyroglutamate-Abeta, ACI-24.060 targets the same toxic species as disease modifying anti-Abeta monoclonal antibodies that slowed AD progression in Phase 3 clinical trials. As ACI-24.060, created using our SupraAntigen(R) platform, specifically targets the most toxic forms of Abeta, we believe it may offer best-in-class efficacy with all the potential advantages in safety, administration and distribution that can be expected from a vaccine. We look forward to showing in first half 2024 the effect of ACI-24.060 on amyloid plaque reduction, a surrogate marker for disease modification. The ABATE study is a Phase 1b/2, multicenter, adaptive, double-blind, randomized, placebo-controlled study to assess the safety, tolerability, immunogenicity, and pharmacodynamic effects of ACI-24.060 in subjects with prodromal Alzheimer's disease and in adults with Down syndrome. All participants in the trial must have brain Abeta pathology confirmed by a positron emission tomography (PET) scan. Recent clinical studies and FDA approvals have validated Abeta as a disease modifying therapeutic target in AD and are supportive of Abeta PET imaging as a surrogate marker of efficacy. The trial begins with a dose escalation phase in AD patients, during which various doses/dosing regimens may be evaluated, and also includes individuals with DS. About AD in Down syndrome Individuals with Down syndrome (DS) have a third copy of all or part of chromosome 21, which contains the gene that codes for amyloid-precursor protein (APP). Overproduction of APP is believed to cause the accumulation of Abeta plaques. Virtually all individuals with DS will develop Abeta plaques and AD(1), with DS-related AD sharing a similar pathophysiology and biomarkers with other forms of genetic AD. Given the more predictable onset and progression of symptoms in DS-related AD, AC Immune believes ABATE's results will offer crucial insights into the ability of ACI-24.060 active immunotherapy to modulate neurodegeneration at its earliest stages and offer this population a much needed therapeutic option. New Risk • Jun 28
New major risk - Share price stability The company's share price has been highly volatile over the past 3 months. It is more volatile than 90% of German stocks, typically moving 20% a week. This is considered a major risk. Share price volatility increases the risk of potential losses in the short-term as the stock tends to have larger drops in price more frequently than other stocks. It may also indicate the stock is highly sensitive to market conditions or economic conditions rather than being sensitive to its own business performance, which may also be inconsistent. Currently, the following risks have been identified for the company: Major Risk Share price has been highly volatile over the past 3 months (20% average weekly change). Minor Risks Currently unprofitable and not forecast to become profitable over next 3 years (CHF41m net loss in 3 years). Revenue is less than US$5m (CHF3.9m revenue, or US$4.4m). Annonce • Jun 24
AC Immune SA Announces Not Stand for Re-Election of Board of Directors AC Immune SA announced that Alan Colowick and Tom Graney did not stand for re-election as Board of Directors at annual general meeting held on June 23, 2023. Annonce • May 25
AC Immune SA, Annual General Meeting, Jun 23, 2023 AC Immune SA, Annual General Meeting, Jun 23, 2023, at 14:30 Central European Standard Time. Location: EPFL Innovation PArk Buidling F Ground Floor, Rooms Luna/Jupiter 1-15 Lausanne Lausanne Switzerland Agenda: to consider 2022 IFRS Consolidated Financial Statements, 2022 Statutory Financial Statements and 2022 Compensation Report; and to consider any other matters. Annonce • Jan 27
AC Immune’s ACI-24.060 Anti-Amyloid Beta Vaccine for Alzheimer’s Shows Positive Initial Interim Safety and Immunogenicity in Phase 1b/2 ABATE Trial AC Immune SA announced the first interim safety, tolerability and immunogenicity findings from the Phase 1b/2 ABATE trial of its anti-amyloid-beta (Abeta) vaccine ACI-24.060 in patients with prodromal Alzheimer’s disease (AD). ABATE will now be expanded, as planned, to include individuals with Down syndrome (DS) and to evaluate higher doses in Alzheimer’s patients. Targeting Abeta using antibodies has recently been validated with FDA approvals of new monoclonal antibody treatments for patients with AD. By eliciting polyclonal anti-Abeta antibodies, the ACI-24.060 anti-Abeta vaccine development program aims to ultimately deliver significant benefits to patients, their caregivers, and healthcare systems in terms of potential safety and tolerability, low frequency dosing, low overall costs and durable responses. Early results from the first cohort of AD patients in ABATE showed that low dose ACI-24.060 could elicit an anti-Abeta antibody response as soon as week 6 (2 weeks after the second injection). The data show that ACI-24.060 vaccination has been safe and well tolerated to date. As a result, dosing in ABATE’s second, higher dose AD cohort has now begun and the trial is cleared to begin screening individuals with DS for part 2 of the study. The ABATE study is a Phase 1b/2, multicenter, adaptive, double-blind, randomized, placebo-controlled study to assess the safety, tolerability, immunogenicity, and pharmacodynamic effects of ACI-24.060 in subjects with prodromal Alzheimer’s disease and in adults with Down syndrome. All participants in the trial must have brain Abeta pathology confirmed by a positron emission tomography (PET) scan. The trial begins with a dose escalation phase in AD patients, during which various doses/dosing regimens may be evaluated, and also includes individuals with DS. ACI-24.060, derived from AC Immune’s SupraAntigen® platform, has been shown in preclinical studies to induce a strong polyclonal antibody response that matures and is maintained against both oligomeric and pyroglutamate-Abeta species, key pathological forms of Abeta believed to drive Abeta plaque formation and disease progression. ACI-24.060 is designed to enhance the formation of broad-spectrum protective antibodies with the same safety and tolerability previously demonstrated in the ACI-24 program in Phase 1 and 2 trials. This investigational candidate has the potential to efficiently inhibit plaque formation and increase plaque clearance, and thereby may reduce or prevent disease progression. Annonce • Dec 01
AC Immune’s Alzheimer’s Disease Vaccine-Candidate ACI-35.030 Selected for Further Development AC Immune SA announced that based on the Phase 1b/2a interim data, ACI-35.030, a potential first-in-class anti-phosphorylated-Tau (pTau) vaccine candidate, has been selected for further development. The ACI-35.030 anti-pTau vaccine candidate is being developed in collaboration with Janssen Pharmaceuticals Inc. (Janssen), part of the Janssen Pharmaceutical Companies of Johnson & Johnson. The selection of ACI-35.030 is supported by new clinical data from the Phase 1b/2a trial presented at the Clinical Trials on Alzheimer’s Disease (CTAD) Conference 2022. The results show that ACI-35.030 treatment rapidly leads to the strong and durable induction of antibodies specific for pathological forms of Tau such as pTau and its aggregated form, ePHF. The ACI-35.030-induced antibody response was sustained and could be periodically boosted over a period of 72 weeks. The vaccine candidate was generally well tolerated. The decision to select ACI-35.030 follows the comparison, presented at CTAD, demonstrating its strengths relative to a protein conjugate vaccine, JACI-35.054, an alternative anti-pTau vaccine also being evaluated in parallel in the Phase 1b/2 trial. Annonce • Oct 05
AC Immune SA Opens New Centers in Phase 1b/2 Trial Evaluating ACI-24 Targeting Abeta in Alzheimer’s Disease and Down Syndrome AC Immune SA provided an update on the Phase 1b/2 ABATE study of its anti-amyloid-beta vaccine candidate ACI-24.060 in patients with prodromal Alzheimer’s disease and individuals with Down syndrome. With regulatory clearances now in both the UK and Spain, clinical sites are open and recruiting. ABATE is an ongoing two-part, multicenter, placebo-controlled phase 1b/2 trial evaluating the safety, tolerability, immunogenicity and pharmacodynamic effect of ACI-24.060. The biomarker-based design of the ABATE trial, with multiple interim analyses, will enable early and informed decision-making with rapid de-risking of the study and a safe transition into the more vulnerable DS population. Only patients with prodromal AD are enrolled in part 1, while part 2 focuses on individuals living with DS. AC Immune is preparing to submit a U.S. Investigational New Drug (IND) application in First Quarter 2023. The first interim analysis of the Phase 1b part of the study is expected around the end of 2022, enabling progression into Phase 2 in individuals with DS. The combination of the two study populations, which display striking similarities in their biomarker patterns, provides important learnings between prodromal AD and individuals with DS, a population at extreme risk of developing AD. The trial design provides multiple opportunities to accelerate development, in terms of expansion of this study and the initiation of pivotal and prevention trials. Annonce • Aug 03
AC Immune SA Presents Detailed Data from the Phase II Crenezumab Alzheimer’s Prevention Initiative Study in Autosomal Dominant Alzheimer’s Disease Presented At AAIC AC Immune SA announced that its partners presented the first quantitative data from the Alzheimer’s Prevention Initiative (API) Autosomal Dominant Alzheimer's Disease (ADAD) Colombia Trial during a Focused Topic Session at the Alzheimer’s Association International Conference (AAIC). The study evaluated the potential of the anti-amyloid beta antibody crenezumab to slow or prevent Alzheimer’s disease in cognitively unimpaired people who carry a specific genetic mutation which causes early-onset Alzheimer’s disease. As previously reported on June 16, 2022, the trial did not meet its co-primary endpoints (API ADAD composite cognitive total score and the Free and Cued Selective Reminding Test Cueing Index). Numerical differences favoring crenezumab over placebo were observed across both of these co-primary endpoints; statistical significance was not reached. Additional clinical and biomarker measures also showed numerical differences favoring crenezumab over placebo that did not reach statistical significance. Clinical endpoints showed the following relative changes in annualized scores compared to placebo, in all cases favoring crenezumab though in all cases not statistically significant: Cognitive test scores: API ADAD composite 22.9% (p=0.43); FCSRT 19.9% (p=0.16); RBANS total score 43.8% (p=0.55); Clinical/function: Time to MCI/dementia due to AD 20.8% (p=0.48); time to non-Zero in CDR-GS 8.1% (p=0.76); CDR Sum of Boxes 8.8% (p=0.64). Biomarker results also favored crenezumab with the following relative changes compared to placebo, all favoring crenezumab though not statistically significant: PET measures: Aß PET SUVR 3.6% (p=0.69); Tau-PET SUVR 51.1% (p=0.20); FDG PET SUVR 18.1% (p=0.25); CSF measures: t-tau 28.7% (p=0.53); p-tau-181 37.4% (p=0.28); NfL 18.2% (p=0.46). The API ADAD trial enrolled 252 people who are members of the world’s larger extended family with ADAD in Colombia. Two-thirds of participants carried the Presenilin 1 E280A mutation which typically causes cognitive impairment due to Alzheimer’s disease around age 44. Approximately half of enrolled mutation carriers were negative for amyloid beta at enrolment. Participants were randomized to receive crenezumab or placebo for a planned duration of five to eight years. During the trial, the dose of crenezumab was increased more than seven-fold as knowledge about potential treatment approaches for Alzheimer’s disease evolved. The average age of mutation carriers enrolled in the trial was 37. Limitations of the API ADAD study noted in the AAIC presentation included limited statistical power to determine whether treatment with crenezumab at the optimal dose, which was received by most subjects for only about two out of five years, would have a clinical benefit. Demographic and baseline data indicate the study’s lower-than-expected statistical power may have been due to a confluence of factors, including a study population that was on average younger and at an earlier preclinical Alzheimer's disease stage than expected. Annonce • Jun 17
AC Immune SA Provides Update on Alzheimer's Prevention Initiative Study Evaluating Crenezumab in Autosomal Dominant Alzheimer’s Disease AC Immune SA announced results from the Alzheimer’s Prevention Initiative (API) Autosomal Dominant Alzheimer's Disease (ADAD) Colombia Trial. The study evaluated the potential of crenezumab, an investigational medicine, to slow or prevent Alzheimer’s disease in cognitively unimpaired people who carry a specific genetic mutation which causes early-onset Alzheimer’s disease. Numerical differences favouring crenezumab over placebo were observed across the co-primary, multiple secondary and exploratory endpoints, though none were statistically significant. The co-primary endpoints assessed the rate of change in cognitive abilities or episodic memory function, measured by the API ADAD composite cognitive total score and the Free and Cued Selective Reminding Test (FCSRT) Cueing Index, respectively. Crenezumab was generally well tolerated during the study and no new safety issues were identified. Further analyses of data are ongoing. Initial data will be presented at the Alzheimer's Association International Conference (AAIC) on August 2, 2022. The trial enrolled 252 people who are members of the world’s largest extended family with ADAD in Colombia. Two-thirds of participants carried the Presenilin 1 E280A mutation which typically causes cognitive impairment due to Alzheimer’s disease around age 44. Participants were randomised to receive crenezumab or placebo over five to eight years. During the trial, the dose of crenezumab was increased as knowledge about potential treatment approaches for Alzheimer’s disease evolved. The study, which was supported by National Institute on Aging, generous philanthropic contributions to Banner Alzheimer’s Foundation, and Roche, has generated a wealth of data that will advance the early detection, tracking and study of Alzheimer’s disease and inform the design of future Alzheimer’s prevention trials. Crenezumab is an investigational treatment discovered by AC Immune SA and designed to neutralise a pathological species of the beta-amyloid protein called oligomers. It is developed by Genentech, a member of the Roche Group, under a license and collaboration agreement established in 2006. The Alzheimer’s Prevention Initiative (API) is an international collaborative formed in 2009 to launch a new era of Alzheimer’s prevention research. Led by the Banner Alzheimer’s Institute, the API conducts prevention trials in cognitively healthy people at increased risk for Alzheimer’s disease. API continues to establish brain imaging, fluid biomarker and cognitive endpoints needed to rapidly test promising prevention therapies. It also leads participant recruitment registries to accelerate enrollment into Alzheimer’s-focused studies. API is intended to provide the scientific means, accelerated approval pathway and enrollment resources needed to evaluate the range of promising Alzheimer’s prevention therapies and find ones that work without losing another generation. First proposed by investigators from BAI, the API ADAD trial (NCT01998841) was a prospective, randomised, double-blind, placebo-controlled, parallel-group label enabling Phase II study of the efficacy of crenezumab versus placebo in cognitively unimpaired individuals who have no clinical symptoms of Alzheimer’s disease and carry the PSEN1 E280A autosomal dominant mutation. Participants who are mutation carriers were randomised in a 1:1 ratio to receive either crenezumab or placebo for at least 260 weeks. Crenezumab was initially administered subcutaneously 300 mg every two weeks. Dosing was amended in 2015 to 720 mg subcutaneously every two weeks and in 2019 the option to increase the dose to 60 mg/kg, delivered intravenously every four weeks, was offered to participants. A cohort of participants (non-mutation carriers) were also enrolled and dosed solely on placebo. The trial, which was supported by National Institute on Aging's (NIA) generous philanthropic contributions to Banner Alzheimer’s Foundation and Roche, was the first NIH-supported prevention trial of an experimental prevention therapy in cognitively unimpaired persons at known risk for the disease. Annonce • May 27
AC Immune SA, Annual General Meeting, Jun 24, 2022 AC Immune SA, Annual General Meeting, Jun 24, 2022, at 14:30 Central European Standard Time. Agenda: To consider 2021 IFRS Consolidated Financial Statements, 2021 Statutory Annual Report and 2021 Compensation Report ;to consider appropriation of loss; to consider Discharge of the Board of Directors and of the Executive Committee; to consider compensation for the Members of the Board of Directors and the Executive Committee; to consider re-election of directors and board members; to consider changes to the Articles of Association; and to consider other matters. Annonce • May 10
AC Immune SA's Anti-Abeta Vaccine Results from Phase 1b Study in Down Syndrome Published in JAMA Neurology AC Immune SA announced the publication in JAMA Neurology1 of data showing that AC Immune’s ACI-24 anti-Abeta vaccine was found to be safe and elicited immune response in a Phase 1b clinical trial in adults with DS. This is the first anti-Abeta vaccine study conducted with people living with DS. The landmark study was led by principal investigator Michael Rafii, MD, Ph.D., Professor of Neurology at Keck School of Medicine of the University of Southern California and Medical Director of the Alzheimer’s Therapeutic Research Institute (ATRI). The phase 1b multicenter, placebo-controlled clinical trial was a collaboration between AC Immune, the Alzheimer’s Disease Cooperative Study (ADCS), and clinical investigators at Massachusetts General Hospital, Barrow Neurological Institute and University of California San Diego, with financial support from the National Institute on Aging, part of the National Institutes of Health, and the LuMind IDSC Down Syndrome Foundation. As presented in the JAMA Neurology article, the ACI-24 vaccine demonstrated immunogenicity along with pharmacodynamic and target engagement evidence as measured by a greater increase in plasma Abeta40 and Abeta42 in treated groups compared to placebo. Importantly, anti-Abeta antibody titers were not associated with any adverse findings. An optimized formulation of ACI-24 has demonstrated strong immunogenicity, inducing a polyclonal response in non-human primates against Abeta and, importantly, high titers of antibodies targeting pyroGlutamate-Abeta (as published in Brain Communications). This neurotoxic species of Abeta found in amyloid plaques is a key driver of disease progression2. Additional data on the optimized formulation were presented at the AD/PD™ 2022, Alzheimer's & Parkinson's Diseases Conference held on March 15-20. Annonce • Feb 16
AC Immune ACI-35.030 Phase 1b/2a Trial Interim Data Confirm Consistent Safety and Potent Immunogenicity of pTau Alzheimer’s Vaccine in High-dose Cohort AC Immune SA announced new interim 10-week data from the high-dose cohort of a placebo-controlled Phase 1b/2a trial evaluating ACI-35.030, a first-in-class phosphorylated-Tau (pTau) vaccine candidate in participants with early Alzheimer’s disease (AD). The Company previously reported interim data from low-dose and mid-dose cohorts. ACI-35.030, based on AC Immune’s SupraAntigen® platform, is the first AD vaccine candidate designed to generate antibodies targeting pathological pTau in the brain. New interim data from the Phase 1b/2a trial show that the high-dose of ACI-35.030 led to the strong induction of antibodies selective for pTau and its aggregated form, enriched paired helical filaments (ePHF). These data are consistent with those previously announced for the trial’s mid-dose cohort that showed median anti-pTau antibody titers increasing from baseline by two orders of magnitude at week 2 after a first injection. Additional key findings from the high-dose interim analysis include: Results indicate that the induced immune response selectively targets pTau, as shown by an increase in the anti-pTau/anti-Tau IgG ratio over time up to week 10. In this interim data set to week 10, median levels of antibodies reactive with pathological Tau (ePHF) were boosted with both the first and second vaccine injections. Safety data provide further support for ACI-35.030’s favorable safety and tolerability profile, as no clinically relevant safety concerns have been observed to date. Annonce • Feb 05
AC Immune ACI-24 Data in Brain Communications Show Abeta Vaccine-Candidate Induces Immunity Against pyroGlu-Abeta, Key Driver of Alzheimer’s Disease AC Immune SA announced that preclinical data on the optimized formulation of its wholly-owned amyloid-beta (Abeta) vaccine program, ACI-24, were published in the peer reviewed journal Brain Communications. Based on these and other preclinical data, as well as the results of three clinical trials with ACI-24, AC Immune plans to advance clinical development of the optimized formulation to the next stage for both Alzheimer’s disease (AD) and Down syndrome (DS) related AD in 2022. Pyroglutamate Abeta (pyroGlu-Abeta) peptides, truncated forms of the Abeta protein, are highly neurotoxic Abeta species, which are observed only in brain amyloid plaques and believed to be key drivers of AD1. PyroGlu-Abeta peptides’ altered biochemical properties make them more prone to aggregation compared to full-length Abeta and they are a major component of neurotoxic amyloid plaques. A recently published Phase 2 clinical trial showed that a monoclonal antibody targeting pyroGlu-Abeta epitope demonstrated slowing of cognitive and functional decline in early Alzheimer disease patients. Data published in the Brain Communications paper show the optimized ACI-24 formulation induced a broad polyclonal anti-Abeta response, including high titers of antibodies targeting pyroGlu-Abeta variants, and was well tolerated in non-human primates and mice. Specifically, in the study, conducted in mice and non-human primates, optimized ACI-24 generated a strong immune response against both the full length Abeta (Abeta1-42) and pyroGlu-Abeta. Importantly, the anti-pyroGlu-Abeta immune response observed in this newly published study was substantially stronger in animals vaccinated with the optimized ACI-24 vaccine formulation compared to those vaccinated with earlier Abeta vaccines from other companies that have been clinically tested (AN1792 and ACC-001) in this study. Reported Earnings • Nov 09
Third quarter 2021 earnings released: CHF0.22 loss per share (vs CHF0.26 loss in 3Q 2020) Third quarter 2021 results: Net loss: CHF15.9m (loss narrowed 16% from 3Q 2020). Over the last 3 years on average, earnings per share has fallen by 54% per year but the company’s share price has only fallen by 7% per year, which means it has not declined as severely as earnings. Annonce • Sep 02
AC Immune SA Announces First Positive Cognitive Results for a Tau-Targeting Monoclonal Antibody in Alzheimer’s Disease AC Immune SA announced that Genentech, a member of the Roche Group, has informed the Company that Lauriet, a placebo-controlled Phase 2 study evaluating the safety and efficacy of the investigational anti-tau monoclonal antibody, semorinemab, in mild-to-moderate Alzheimer’s disease (AD), met one of its co-primary endpoints, ADAS-Cog11. The second co-primary endpoint, ADCS-ADL, was not met. Safety data showed that semorinemab is well tolerated with an acceptable safety profile and no unanticipated safety signals. Semorinemab demonstrated a statistically significant reduction in cognitive decline from baseline by 43.6% compared to placebo (p<0.0025) as measured by the Alzheimer’s Disease Assessment Scale, Cognitive Subscale, 11-item Version (ADAS-Cog11) at week 49 in people with mild-to-moderate AD (i.e., Mini-Mental State Examination (MMSE) 16-21). There was no effect on the other co-primary endpoint of reducing the rate of functional decline from baseline as measured by the Alzheimer’s Disease Cooperative Study-Activities of Daily Living (ADCS-ADL) or secondary efficacy endpoints for the Mini-Mental State Examination (MMSE) or the Clinical Dementia Rating-Sum of Boxes (CDR-SB). The safety was consistent with previous clinical data reported. Genentech has reported that the open label portion of the study will continue as planned. Further analyses are ongoing, and top-line data will be submitted for presentation at the CTAD conference (Clinical Trials on Alzheimer's Disease conference) in November. Annonce • Jun 03
AC Immune Provides Update on Alzheimer’s Disease Vaccine Candidates Targeting Pathological Amyloid-Beta AC Immune SA provided key clinical and preclinical updates for its SupraAntigen-derived liposomal vaccine candidates, which are designed to convey active, long-lasting immunization against pathological forms of amyloid-beta (Abeta). AC Immune is completing a Phase 2 study of its first clinical candidate, ACI-24, in people with mild Alzheimer’s disease (AD), and is also advancing an optimized ACI-24 formulation, which demonstrates enhanced and sustained immunogenicity in non-human primate studies, particularly against key pathological forms of Abeta such as oligomeric and pyroglutamate Abeta. Pyroglutamate Abeta (pyroGlu-Abeta) is a highly neurotoxic form of Abeta that is N-terminally truncated and post-translationally modified to form pyroglutamate. Extracellular pyroGlu-Abeta is an important target for immunotherapy, as the peptide’s altered biochemical properties make it more prone to aggregate compared to full-length Abeta, and it is a major component of Abeta plaques. Passive immunization with a monoclonal antibody specific for pyroglutamate Abeta demonstrated encouraging clinical results in a recently published Phase 2 clinical study. In addition, AC Immune completed an 18-month interim assessment of safety and tolerability in the Phase 2 study evaluating ACI-24 in patients with mild AD. Confirming earlier interim results, there have been no safety concerns nor evidence for CNS inflammation or ARIA (amyloid-related imaging abnormalities) related to ACI-24 in any subject. AC Immune will complete the Phase 2 study with the 24-month analysis on the basis of currently enrolled patients. Reported Earnings • Mar 25
Full year 2020 earnings released: CHF0.86 loss per share (vs CHF0.64 profit in FY 2019) The company reported a poor full year result with weaker earnings, revenues and control over costs. Full year 2020 results: Revenue: CHF15.4m (down 86% from FY 2019). Net loss: CHF61.9m (down 236% from profit in FY 2019). Products in clinical trials Phase I: 2 Phase II: 5 Over the last 3 years on average, earnings per share has increased by 1% per year but the company’s share price has fallen by 8% per year, which means it is significantly lagging earnings. Annonce • Mar 17
AC Immune SA Announces New Clinical Results in Down Syndrome and Plans for Future Development of Anti-Amyloid-Beta Vaccine AC Immune SA announced plans to advance its novel anti-amyloid-beta (Abeta) vaccine into mid-stage clinical testing to treat and prevent the progression of Down syndrome (DS)-related Alzheimer’s disease (AD). Topline results reported by AC Immune’s Chief Scientific Officer, Dr. Marie Kosco-Vilbois, at a global DS symposium co-sponsored by AC Immune, showed that ACI-24 demonstrated encouraging immunogenicity and safety in Phase 1b clinical testing in people with DS. The company also disclosed new non-human primate data for an optimized formulation of the vaccine, which shows broad potential for the treatment and prevention of Abeta-driven diseases based on its superior efficacy in non-human primates. Key preclinical results for the optimized anti-Abeta vaccine formulation in NHPs: The optimized vaccine formulation primes, boosts, and maintains strong anti-Abeta antibody responses in two NHP species; The optimized vaccine formulation generates conformation-specific antibodies targeting key pathological Abeta species, including oligomeric and pyroglutamate Abeta; The antibodies elicited by the optimized vaccine formulation in NHPs showed clear target engagement by binding to human Abeta plaques on AD patient-derived brain tissue. ACI-24 is also currently being tested in a Phase 2 clinical trial in patients with mild AD. In this study, there have been no safety concerns nor evidence for CNS inflammation or ARIA related to ACI-24 in any subject. The Phase 2 study is progressing toward an 18-month interim analysis, which is planned for second quarter 2021. Annonce • Mar 11
AC Immune Presents New Preclinical Data for Therapeutic and Diagnostic Candidates Addressing Novel Targets for Neurodegenerative Diseases AC Immune SA outlined new preclinical data that will be presented at the 15thInternational Conference on Alzheimer’s & Parkinson’s Diseases, taking place virtually from March 9–14, 2021. Data from the company’s wholly owned, first-in-class therapeutic and diagnostic programs targeting pathological forms of alpha-synuclein and TAR DNA-binding protein 43 (TDP-43) are described during four oral and e-poster presentations. Together the presentations further illustrate the synergy between AC Immune’s SupraAntigen™ and Morphomer™ technology
platforms to deliver a precision medicine approach to treating neurodegenerative diseases (NDD). Alpha-synuclein and TDP-43 are hallmarks of major NDD such as Parkinson’s disease and limbic-predominant age-related TDP-43 encephalopathy (LATE), respectively, and are well-recognized co-pathologies in Alzheimer’s disease linked to accelerated cognitive decline. AC Immune targets pathological forms of these proteins with highly specific antibody and small molecule therapeutics, as well as first-in-class positron emission tomography (PET) diagnostic candidates, which are amongst the most advanced in the field. Annonce • Feb 25
AC Immune to Present New Data from Alpha-Synuclein and TDP-43 Programs at the AD/PD™ 2021 Virtual Conference AC Immune SA announced that four new data presentations will be delivered at the 15thInternational Conference on Alzheimer’s & Parkinson’s Diseases (AD/PDTM), taking place virtually from March 9–14, 2021. The presentations will highlight preclinical results from the Company’s wholly-owned therapeutic and diagnostic programs targeting pathological forms of alpha-synuclein and TAR DNA-binding protein 43 (TDP-43) for neurodegenerative diseases. The presentations will showcase how AC Immune’s expertise in discovery, assay development and characterization of promising candidates powers its pipeline. Two oral presentations will highlight the Company’s first-in-class positron emission tomography (PET) imaging agent and therapeutic antibody programs targeting TDP-43 proteinopathies, and two electronic poster presentations will focus on AC Immune’s novel small molecule aggregation inhibitor and clinical-stage PET imaging agent for alpha-synuclein. Annonce • Feb 13
AC Immune’s Alzheimer’s Vaccine Generates Potent Anti-pTau Antibody Response in a Phase 1b/2a Study AC Immune SA announced positive interim results from its ongoing Phase 1b/2a clinical trial evaluating its first-in-class anti-phospho-Tau vaccine candidate ACI-35.030 for the treatment of Alzheimer’s disease. ACI-35.030 vaccination generated a potent antigen-specific antibody response against pTau in 100% of older patients with early AD, achieving antibody levels several orders of magnitude higher than pre-vaccination levels. No clinically relevant adverse events were observed. AC Immune and strategic partner Janssen Pharmaceuticals Inc., believe these interim findings from the first two dosing groups support plans to advance the development of ACI-35.030 for the treatment of AD. Immunization with anti-Tau vaccines represents a novel strategy for the treatment of AD and other neurodegenerative diseases characterized by Tau pathology. ACI-35.030 is a first-in-class vaccine candidate designed to generate a specific antibody response against pTau proteins in the brain. Anti-pTau antibodies generated by ACI-35.030 have the potential to reduce the spread and seeding of Tau pathology, which is a major hallmark of AD. These new results provide encouraging clinical support for ACI-35.030, which employs a new vaccine formulation to achieve active immunization that significantly improves antibody responses in older patients with potentially attenuated immune systems. Notably, anti-pTau vaccination generates antibody responses with pharmacokinetic characteristics and target epitopes that differ substantially from the Company’s anti-Tau monoclonal antibody semorinemab, highlighting the comprehensive and complementary nature of AC Immune’s anti-Tau pipeline. Interim data from the Phase 1b/2a study showed: Anti-Tau IgG response preferentially targets phosphorylated Tau in all patients; 100% of patients demonstrated an anti-pTau IgG response after the 1st injection for both lowest and second highest dosages; Very high anti-pTau IgG titers observed following injection; Anti-pTau IgM response was also elicited in all patients for both doses; ACI-35.030 was safe and well tolerated with no clinically relevant safety concerns observed to date. The companies plan to advance to the third and highest dosing group, per the study protocol. ACI-35.030 is derived from AC Immune's proprietary SupraAntigenTM platform, which accelerates the discovery and development of conformation specific antibodies and vaccine candidates to power successful therapeutic and diagnostic approaches. Additional clinical-stage candidates derived from this platform include ACI-24, a proprietary anti-amyloid beta (Abeta) vaccine, crenezumab, an anti-Abeta monoclonal antibody, and semorinemab, an anti-Tau monoclonal antibody, which is in Phase 2 development for the treatment of moderate AD. Annonce • Feb 09
AC Immune SA Initiates Clinical Study of First-in-class Diagnostic for Parkinson’s Disease AC Immune SA announced that the first patient has been scanned in a first-in-human study of its novel diagnostic agent for Parkinson’s disease (PD). ACI-12589 is a next-generation positron emission tomography (PET) imaging tracer that has shown significant potential to reliably detect and map deposits of pathological alpha-synuclein protein in the brain, which is the major hallmark of PD. AC Immune expects to report the results of the study in third quarter of 2021. The clinical study is supported by the Michael J. Fox Foundation for Parkinson’s Research (MJFF), building on The Foundation’s significant funding of AC Immune’s program since 2015. Alpha-synuclein misfolding and aggregation are the molecular basis for the formation of pathological Lewy bodies and neurites, which are characteristic of PD and other alpha-synucleinopathies such as multiple system atrophy (MSA) and Lewy body dementia (LBD). In preclinical studies, ACI-12589 demonstrates significantly improved target occupancy and binds to PD patient-derived tissue with improved sensitivity and specificity compared to AC Immune’s prior-generation candidates. These favorable characteristics highlight the significant potential of ACI-12589 to become the world’s first diagnostic tool for assessing brain alpha-synuclein pathology in PD. An effective diagnostic may enable accurate, potentially earlier diagnosis as well as monitoring of disease progression to facilitate longitudinal drug efficacy measurements in patients. AC Immune’s PET tracers are derived from the Company’s innovative Morphomer technology platform, which accelerates the design, development and synthesis of conformation-specific, CNS- and cell-penetrant small molecules to power successful diagnostic and therapeutic approaches. The Morphomer™ platform has produced multiple small molecules that have been validated in clinical studies, including both therapeutic and diagnostic candidates that selectively target pathological forms of Tau protein. In addition to ACI-12589, AC Immune is advancing Morphomer-derived small molecule aggregation inhibitors that significantly decrease alpha-synuclein aggregate formation in cellular assays with favorable pharmacokinetic properties for further evaluation in vivo. Is New 90 Day High Low • Feb 04
New 90-day high: €5.57 The company is up 16% from its price of €4.80 on 05 November 2020. The German market is also up 16% over the last 90 days, indicating the company’s price trend is similar to the market over that time. However, it outperformed the Biotechs industry, which is up 9.0% over the same period. Annonce • Jan 31
Ac Immune Reports Progress for Therapeutic Programs Targeting the Nlrp3 Inflammasome Pathway AC Immune SA announced recent advancements in its small molecule- and antibody-based therapeutic programs targeting the -like receptor protein 3 inflammasome, a multi-protein complex that activates downstream inflammatory pathways leading to neuronal damage. The inflammasome is a highly valued therapeutic target implicated in a wide range of neurodegenerative disorders including Alzheimer’s disease, as well as in non-central nervous system indications, such as autoimmune and infectious diseases, as well as certain cancers. Leveraging the know-how of its proprietary Morphomer™ platform, which generated AC Immune’s clinical stage small molecule Tau aggregation inhibitors, the Company has successfully identified, and filed patent applications for, various chemical series of potent small molecule NLRP3 inhibitors. AC Immune has established biological activity for these compounds in multiple functional assays, and initial animal studies show highly potent target inhibition in a model of peripheral inflammation, providing the first evidence of in vivo activity. AC immune is currently evaluating potential lead compounds for further in vivo efficacy and CNS delivery. The Company expects to initiate in vivo proof-of-concept studies for a CNS-optimized lead compound for development in AD and other key neurodegenerative diseases by year end, as well as evaluate the potential of a second lead molecule in a clinically relevant non-CNS disease model. A critical component of the NLRP3 pathway is ASC (apoptosis-associated speck-like protein containing a C-terminal caspase recruitment domain), which is released by immune cells following NLRP3 inflammasome activation. ASC interacts with amyloid beta (Abeta) in Alzheimer’s disease, not only increasing aggregation but also inducing seeding and spreading of Abeta pathology. AC Immune’s SupraAntigen™ platform has successfully generated high-affinity antibodies binding extracellular human ASC and potently inhibiting ASC-mediated inflammatory responses in vitro. Selected antibodies will be further evaluated in vivo proof-of-concept studies using animal models of human disease, which AC Immune expects to start by year end. Is New 90 Day High Low • Jan 11
New 90-day high: €5.17 The company is up 22% from its price of €4.22 on 13 October 2020. The German market is up 8.0% over the last 90 days, indicating the company outperformed over that time. It also outperformed the Biotechs industry, which is up 1.0% over the same period. Annonce • Dec 17
AC Immune SA Receives Competitive Target ALS Foundation Grant to Accelerate the Development of Proprietary Phosphorylated TDP-43 Immuno-assay AC Immune SA announced the receipt of a highly competitive grant awarded by Target ALS. The grant, which was awarded in response to the organization’s call for new industry-led biomarker consortia projects, will support a world-class collaboration between AC Immune and Investigators at the Healey Center for ALS at Massachusetts General Hospital to accelerate the development of the Company’s proprietary immuno-assays to detect disease-associated forms of TAR DNA-binding protein 43 (TDP-43) in cerebrospinal fluid and blood samples. The pathological aggregation of TDP-43 is strongly associated with motor and cognitive decline and episodic memory loss in several neurodegenerative diseases including amyotrophic lateral sclerosis (ALS), frontotemporal lobar degeneration with TDP-43 pathology (FTLD-TDP) and limbic-predominant age-related TDP-43 encephalopathy (LATE). AC Immune’s SupraAntigenTM-based detection assays for aggregation-prone forms of TDP-43 in biofluids have the potential to serve as an early-stage diagnostic that may enable the development of precision medicine approaches for these diseases as well as Alzheimer’s disease (AD), where pathological aggregation of TDP-43 has emerged as an important co-pathology linked to disease severity. AC Immune’s proprietary immuno-assays utilize anti-TDP-43 antibodies derived from the Company’s innovative SupraAntigenTM platform, which accelerates the discovery and development of conformation-specific antibodies to successful diagnostic and therapeutic approaches. The SupraAntigenTM platform has produced multiple antibodies that bind selectively to pathological forms of human proteins involved in neurodegenerative disease such as Tau, Abeta, TDP-43, alpha-synuclein and NLRP3-ASC. This grant will accelerate the development AC Immune’s anti-pTDP-43 immuno-assay to enable ex vivo diagnostic tests capable of identifying early stages of TDP-43 related diseases such as ALS. Such diagnostic tests may facilitate the effective treatment of these diseases. Annonce • Nov 21
AC Immune Sa Appoints Carl H. June as Board of Directors AC Immune SA announced that Prof. Carl H. June was elected to the company’s Board of Directors, at an extraordinary shareholders’ meeting held on November 20, 2020. Prof. June is a true pioneer in the field of immunotherapy most well-known for his research into T cell therapies for the treatment of cancer, who, in 2020, was elected to the American Philosophical Society. His expertise can further accelerate AC Immune’s progress in advancing its pipeline of immunotherapies and therapies targeting neuroinflammation. Prof. June is Richard W. Vague Professor in Immunotherapy, Director of the Center for Cellular Immunotherapies and Director of the Parker Institute for Cancer Immunotherapy at the Perelman School of Medicine at the University of Pennsylvania. Due to his lifelong work on lymphocyte activation, Prof. June is considered a world authority on mechanisms related to immune tolerance and adoptive immunotherapy in the fields of chronic inflammation and cancer. He and his team pioneered the work in immunotherapy in which patients with refractory and relapsed chronic lymphocytic leukemia are treated with genetically engineered versions of their own T cells. This CAR-T therapy approach, which trains the immune system to attack and destroy cancer cells, has opened a new era of innovative treatments and personalized medicine for cancer patients.Prof. June is a graduate of the Naval Academy in Annapolis, USA, and Baylor College of Medicine in Houston, USA, where he received his medical degree. Prof. June also completed graduate training in immunology and malaria with Dr. Paul-Henri Lambert at the World Health Organization, Geneva, Switzerland, and post-doctoral training in transplantation biology with E. Donnell Thomas and John Hansen at the Fred Hutchinson Cancer Research Center in Seattle, USA. Annonce • Nov 19
AC Immune SA Hires Johannes R. Streffer as Chief Medical Officer AC Immune SA announced that Prof. Johannes R. Streffer, an authority on neurology and psychiatry, was hired as the Company’s Chief Medical Officer, and he is expected to join the Company in January 2021. Prof. Streffer joins AC Immune from UCB Biopharma SPRL where he currently holds the position of Vice President, Head of Translational Medicine Neuroscience. His expertise will further accelerate AC Immune’s progress in advancing its pipeline of therapies targeting neurodegenerative diseases. Analyst Estimate Surprise Post Earnings • Nov 14
Revenue beats expectations Revenue exceeded analyst estimates by 98%. Over the next year, revenue is forecast to grow 136%, compared to a 372% growth forecast for the Biotechs industry in Germany. Reported Earnings • Nov 14
Third quarter 2020 earnings released: CHF0.26 loss per share The company reported a poor third quarter result with weaker earnings, revenues and control over expenses. Third quarter 2020 results: Revenue: CHF1.12m (down 97% from 3Q 2019). Net loss: CHF19.0m (down 204% from profit in 3Q 2019). Over the last 3 years on average, earnings per share has increased by 27% per year but the company’s share price has fallen by 23% per year, which means it is significantly lagging earnings. Annonce • Nov 10
AC Immune and WuXi Biologics Strengthen Strategic Partnership to Accelerate AC Immune’s Anti-TDP-43 Antibodies into Clinical Development AC Immune SA and WuXi Biologics unveiled plans to accelerate advancement of AC Immune’s TDP-43 antibody into clinical development for NeuroOrphan indications. This next phase of the strategic partnership between the companies builds on the industry leading know-how of AC Immune’s proprietary drug discovery and development platforms and WuXi Biologics’ expertise in manufacturing innovative biologics. A particular focus is developing AC Immune’s clinical antibody candidate to ensure it has high-affinity for TDP-43 and is capable of preventing the intercellular spread of toxic species. With no disease modifying therapies currently available that target TDP-43 there is significant unmet need and market potential. The expansion of the partnership between the companies with the new agreement, follows data presented at this year’s AAT-AD/PD™ conference [2] on AC Immune’s SupraAntigen™-derived anti-TDP-43 therapeutic antibody candidate, which supported advancement into IND-enabling studies. Through the new agreement, AC Immune gains access to WuXi Biologics’ proprietary platforms including cell line development platform, for the clinical manufacturing of AC Immune’s TDP-43 monoclonal antibodies. Under the agreement, AC Immune retains all intellectual property rights to molecules. Is New 90 Day High Low • Oct 21
New 90-day low: €3.83 The company is down 38% from its price of €6.16 on 22 July 2020. The German market is down 1.0% over the last 90 days, indicating the company underperformed over that time. It also underperformed the Biotechs industry, which is down 12% over the same period. According to the Simply Wall St valuation model, the estimated intrinsic value of the company is per share. Annonce • Oct 11
AC Immune SA Announces EU Grant Supports Collaboration to Accelerate Development of AC Immune's First-in-Class TDP-43 Diagnostic Agent Immune SA announced that a highly competitive European Union grant has been awarded to support the partnership between AC Immune and the JPND ImageTDP-43 consortium to accelerate development of the Company’s first-in-class TDP-43 positron emission tomography (PET) tracer. The grant, which is awarded in response to the European UnionJPND’s call for novel imaging and brain stimulation methods and technologies related to neurodegenerative diseases, will be spearheaded through a world-class collaboration with the University of Zurich, Fondazione Santa Lucia-IRCCS, Skåne University Hospital, the International Centre for Genetic Engineering and Biotechnology, and the Erasmus University Medical Center through the JPND’s ImageTDP-43 Consortium. Advancement of AC Immune’s TDP-43 PET tracer could deliver the world’s first imaging agent capable of accurately detecting and monitoring the progression of a wide range of TDP-43-related neurodegenerative diseases such as amyotrophic lateral sclerosis (ALS), frontotemporal lobar degeneration with TDP-43 pathology (FTLD-TDP) and limbic-predominant age-related TDP-43 encephalopathy (LATE). Such a TDP-43 imaging agent may also enable the development of precision medicine approaches for Alzheimer’s disease (AD), where pathological aggregation of TDP-43 has emerged as an important co-pathology linked to disease severity. Annonce • Sep 24
AC Immune Reports Top Line Results from TAURIEL Phase 2 Trial Evaluating Semorinemab in Early Alzheimer’s Disease AC Immune SA announced that Genentech, a member of the Roche Group, has informed the Company of top line results from a Phase 2 trial of the anti-Tau antibody, semorinemab, in early (prodromal to mild) Alzheimer’s disease (AD) which show that semorinemab did not meet its primary efficacy endpoint of reducing decline on Clinical Dementia Rating-Sum of Boxes (CDR-SB) compared to placebo. Two secondary endpoints, Alzheimer’s Disease Assessment Scale-Cognitive Subscale 13 (ADAS-Cog13) and Alzheimer’s Disease Cooperative Study Group " Activities of Daily Living Inventory (ADCS-ADL) were also not met. Additional data analyses are ongoing and Genentech plans to present the results from TAURIEL at an upcoming medical congress. The second Phase 2 (LAURIET) study of semorinemab in patients with moderate AD remains ongoing. Is New 90 Day High Low • Sep 24
New 90-day low: €4.25 The company is down 29% from its price of €5.97 on 26 June 2020. The German market is up 3.0% over the last 90 days, indicating the company underperformed over that time. It also underperformed the Biotechs industry, which is up 1.0% over the same period. According to the Simply Wall St valuation model, the estimated intrinsic value of the company is per share.