Aankondiging • 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. Aankondiging • May 14
AC Immune SA, Annual General Meeting, Jun 11, 2026 AC Immune SA, Annual General Meeting, Jun 11, 2026. Aankondiging • 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. Aankondiging • 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. Aankondiging • 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. Aankondiging • 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. Aankondiging • 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 Aankondiging • 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. Aankondiging • 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. Aankondiging • 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. Aankondiging • 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 Aankondiging • 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. Aankondiging • 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 Aankondiging • 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 22
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: Minor Risks Currently unprofitable and not forecast to become profitable over next 3 years (CHF20m net loss in 3 years). Share price has been volatile over the past 3 months (15% average weekly change). Shareholders have been diluted in the past year (21% increase in shares outstanding). Major Estimate Revision • May 20
Consensus revenue estimates increase by 299% The consensus outlook for revenues in fiscal year 2024 has improved. 2024 revenue forecast increased from CHF8.33m to CHF33.2m. Forecast losses expected to reduce from -CHF0.659 to -CHF0.445 per share. Biotechs industry in the US expected to see average net income decline 11% next year. Consensus price target up from US$10.38 to US$10.99. Share price fell 3.6% to US$3.18 over the past week. 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 losses will reduce by 15% to 2024. The company is expected to make a profit of CHF7.01m in 2025. Average annual earnings growth of 54% is required to achieve expected profit on schedule. Major Estimate Revision • Mar 21
Consensus revenue estimates fall by 55% The consensus outlook for revenues in fiscal year 2024 has deteriorated. 2024 revenue forecast decreased from CHF27.7m to CHF12.5m. Forecast losses increased from -CHF0.503 to -CHF0.638 per share. Biotechs industry in the US expected to see average net income decline 8.5% next year. Consensus price target broadly unchanged at US$10.42. Share price fell 5.4% to US$3.15 over the past week. Reported Earnings • Mar 15
Full year 2023 earnings: EPS and revenues exceed analyst expectations 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 exceeded analyst estimates by 48%. Earnings per share (EPS) also surpassed analyst estimates by 9.6%. Revenue is forecast to grow 40% p.a. on average during the next 3 years, compared to a 18% growth forecast for the Biotechs industry in the US. 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 25% per year, which means it is significantly lagging earnings. Major Estimate Revision • Jan 31
Consensus revenue estimates fall by 57% The consensus outlook for revenues in fiscal year 2023 has deteriorated. 2023 revenue forecast decreased from CHF23.4m to CHF10.0m. Forecast losses increased from -CHF0.588 to -CHF0.708 per share. Biotechs industry in the US expected to see average net income growth of 11% next year. Consensus price target broadly unchanged at US$10.73. Share price fell 21% to US$3.25 over the past week. Recent Insider Transactions Derivative • Dec 31
Co-Founder notifies of intention to sell stock Andrea Pfeifer intends to sell 94k shares in the next 90 days after lodging an Intent To Sell Form on the 28th of December. If the sale is conducted around the recent share price of US$4.97, it would amount to US$467k. For the year to December 2017, Andrea's total compensation was 36% salary and 64% other compensation. This indicates that these sales could comprise a meaningful part of their income for the year. Since March 2023, Andrea has owned 2.36m shares directly. There have been no trades via on-market transactions or options from company insiders in the last 12 months. 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 Risk 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). Aankondiging • 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 Recent Insider Transactions Derivative • Dec 08
Co-Founder notifies of intention to sell stock Andrea Pfeifer intends to sell 20k shares in the next 90 days after lodging an Intent To Sell Form on the 6th of December. If the sale is conducted around the recent share price of US$3.50, it would amount to US$70k. For the year to December 2017, Andrea's total compensation was 36% salary and 64% other compensation. This indicates that these sales could comprise a meaningful part of their income for the year. Since March 2023, Andrea has owned 2.36m shares directly. There have been no trades via on-market transactions or options from company insiders in the last 12 months. Major Estimate Revision • Nov 15
Consensus revenue estimates fall by 58% The consensus outlook for revenues in fiscal year 2023 has deteriorated. 2023 revenue forecast decreased from CHF55.0m to CHF22.8m. Forecast losses increased from -CHF0.25 to -CHF0.608 per share. Biotechs industry in the US expected to see average net income growth of 5.7% next year. Consensus price target up from US$10.09 to US$10.33. Share price rose 8.8% to US$2.96 over the past week. New Risk • Nov 07
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 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). Recent Insider Transactions Derivative • Aug 25
Co-Founder notifies of intention to sell stock Andrea Pfeifer intends to sell 17k shares in the next 90 days after lodging an Intent To Sell Form on the 22nd of August. If the sale is conducted around the recent share price of US$3.08, it would amount to US$52k. For the year to December 2017, Andrea's total compensation was 36% salary and 64% other compensation. This indicates that these sales could comprise a meaningful part of their income for the year. Since March 2023, Andrea has owned 2.36m shares directly. There have been no trades via on-market transactions or options from company insiders in the last 12 months. New Risk • Aug 04
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: -CHF68m 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: Major Risk Share price has been highly volatile over the past 3 months (21% average weekly change). Minor Risks Less than 1 year of cash runway based on current free cash flow (-CHF68m). Currently unprofitable and not forecast to become profitable over next 3 years (CHF39m net loss in 3 years). Revenue is less than US$5m (CHF3.9m revenue, or US$4.5m). Aankondiging • 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. Recent Insider Transactions Derivative • Jul 13
Co-Founder notifies of intention to sell stock Andrea Pfeifer intends to sell 26k shares in the next 90 days after lodging an Intent To Sell Form on the 10th of July. If the sale is conducted around the recent share price of US$2.98, it would amount to US$77k. Since March 2023, Andrea has owned 2.36m shares directly. There have been no trades via on-market transactions or options from company insiders in the last 12 months. Recent Insider Transactions Derivative • Jul 03
Co-Founder notifies of intention to sell stock Andrea Pfeifer intends to sell 100k shares in the next 90 days after lodging an Intent To Sell Form on the 30th of June. If the sale is conducted around the recent share price of US$3.08, it would amount to US$308k. Since March 2023, Andrea has owned 2.36m shares directly. There have been no trades via on-market transactions or options from company insiders in the last 12 months. Aankondiging • 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 American stocks, typically moving 22% 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 (22% 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). Aankondiging • 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. Aankondiging • 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. Aankondiging • 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. Major Estimate Revision • Dec 21
Consensus forecasts updated The consensus outlook for 2022 has been updated. 2022 revenue forecast increased from CHF4.99m to CHF5.59m. EPS estimate fell from -CHF0.86 to -CHF0.88 per share. Biotechs industry in the US expected to see average net income decline 81% next year. Consensus price target up from US$10.77 to US$11.06. Share price fell 21% to US$1.74 over the past week. Major Estimate Revision • Nov 04
Consensus revenue estimates increase by 75% The consensus outlook for revenues in 2022 has improved. 2022 revenue forecast increased from CHF1.60m to CHF2.80m. Forecast losses expected to reduce from -CHF0.96 to -CHF0.86 per share. Biotechs industry in the US expected to see average net income decline 73% next year. Consensus price target broadly unchanged at US$10.21. Share price was steady at US$2.86 over the past week. Major Estimate Revision • Mar 29
Consensus forecasts updated The consensus outlook for 2022 has been updated. 2022 expected loss increased from -CHF0.39 to -CHF0.93 per share. Revenue forecast of CHF2.00m unchanged since last update. Biotechs industry in the US expected to see average net income decline 46% next year. Consensus price target up from US$14.14 to US$14.46. Share price rose 6.4% to US$4.49 over the past week. Recent Insider Transactions Derivative • Nov 12
Co-Founder notifies of intention to sell stock Andrea Pfeifer intends to sell 49k shares in the next 90 days after lodging an Intent To Sell Form on the 8th of November. If the sale is conducted around the recent share price of US$8.05, it would amount to US$394k. Since December 2020, Andrea's direct individual holding has increased from 2.35m shares to 2.37m. There have been no trades via on-market transactions or options from company insiders in the last 12 months. Reported Earnings • Nov 10
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 5% per year, which means it has not declined as severely as earnings. Recent Insider Transactions Derivative • Sep 04
Co-Founder notifies of intention to sell stock Andrea Pfeifer intends to sell 149k shares in the next 90 days after lodging an Intent To Sell Form on the 31st of August. If the sale is conducted around the recent share price of US$12.09, it would amount to US$1.8m. Since December 2020, Andrea's direct individual holding has increased from 2.35m shares to 2.37m. There have been no trades via on-market transactions or options from company insiders in the last 12 months. Major Estimate Revision • Aug 05
Consensus forecasts updated The consensus outlook for 2021 has been updated. 2021 expected loss increased from -CHF0.18 to -CHF0.44 per share. Revenue forecast of CHF81.8m unchanged since last update. Biotechs industry in the US expected to see average net income decline 13% next year. Consensus price target broadly unchanged at US$15.42. Share price was steady at US$7.12 over the past week. Recent Insider Transactions Derivative • Jun 28
Co-Founder notifies of intention to sell stock Andrea Pfeifer intends to sell 30k shares in the next 90 days after lodging an Intent To Sell Form on the 24th of June. If the sale is conducted around the recent share price of US$8.23, it would amount to US$247k. For the year to December 2019, Andrea's total compensation was 29% salary and 71% other compensation. This indicates that these sales could comprise a meaningful part of their income for the year. Since December 2020, Andrea's direct individual holding has increased from 2.35m shares to 2.37m. There have been no trades via on-market transactions or options from company insiders in the last 12 months. 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 10% per year, which means it is significantly lagging earnings. Major Estimate Revision • Mar 24
Consensus forecasts updated The consensus outlook for 2021 has been updated. 2021 losses forecast to reduce from -CHF0.50 to -CHF0.44 per share. Revenue forecast steady at CHF57.1m. Biotechs industry in the US expected to see average net income growth of 4.2% next year. Consensus price target up from US$12.63 to US$12.95. Share price fell 3.2% to US$7.67 over the past week. Aankondiging • Feb 27
AC Immune SA, Annual General Meeting, Mar 31, 2021 AC Immune SA, Annual General Meeting, Mar 31, 2021, at 14:00 Central European Standard Time. Location: EPFL Innovation Park, Building B Lansanne Switzerland Agenda: To consider election of new Director; to consider amendments of the Articles of Association; to consider Organizational Notes (including measures due to Covid-19); to consider Legal Notice; to consider any other matter thereof. Is New 90 Day High Low • Feb 12
New 90-day high: US$8.43 The company is up 64% from its price of US$5.14 on 13 November 2020. The American market is up 14% over the last 90 days, indicating the company outperformed over that time. It also outperformed the Biotechs industry, which is up 20% over the same period. Is New 90 Day High Low • Jan 26
New 90-day high: US$6.53 The company is up 32% from its price of US$4.94 on 27 October 2020. The American market is up 17% over the last 90 days, indicating the company outperformed over that time. It also outperformed the Biotechs industry, which is up 27% over the same period. Is New 90 Day High Low • Jan 08
New 90-day high: US$5.68 The company is up 11% from its price of US$5.13 on 09 October 2020. The American market is also up 11% over the last 90 days, indicating the company’s price trend is similar to the market over that time. Its price trend is also similar to the Biotechs industry, which is up 11% over the same period. Analyst Estimate Surprise Post Earnings • Nov 15
Revenue and earnings beat expectations Revenue exceeded analyst estimates by 98%. Earnings per share (EPS) also surpassed analyst estimates by 5.4%. Over the next year, revenue is forecast to grow 136%, compared to a 383% growth forecast for the Biotechs industry in the US. Reported Earnings • Nov 15
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 21% per year, which means it is significantly lagging earnings. Is New 90 Day High Low • Oct 20
New 90-day low: US$4.77 The company is down 31% from its price of US$6.91 on 22 July 2020. The American market is up 8.0% over the last 90 days, indicating the company underperformed over that time. It also underperformed the Biotechs industry, which is down 3.0% over the same period. According to the Simply Wall St valuation model, the estimated intrinsic value of the company is per share.