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What changed in AC Immune SA's 20-F — 2024 vs 2025

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Paragraph-level year-over-year comparison of AC Immune SA's 2024 and 2025 20-F annual filings, covering the Business, Risk Factors, Legal Proceedings, Cybersecurity, MD&A and Market Risk sections. Every new, removed and edited paragraph is highlighted side-by-side so you can see exactly what management changed in the 2025 report.

+609 added−701 removedSource: 20-F (2026-03-13) vs 20-F (2025-03-13)

Top changes in AC Immune SA's 2025 20-F

609 paragraphs added · 701 removed · 477 edited across 6 sections

Item 2. Properties

Properties — owned and leased real estate

2 edited+0 added−0 removed0 unchanged
Biggest changeHistory and development of the company 55 B. Business overview 55 C. Organizational structure 121 D. Property, plant and equipment 122
Biggest changeHistory and development of the company 56 B. Business overview 56 C. Organizational structure 112 D. Property, plant and equipment 112
ITEM 2. OFFER STATISTICS AND EXPECTED TIMETABLE 3 A. Offer statistics 3 B. Method and expected timetable 3 ITEM 3. KEY INFORMATION 3 A. [Reserved] 3 B. Capitalization and indebtedness 3 C. Reasons for the offer and use of proceeds 3 D. Risk factors 3 ITEM 4. INFORMATION ON THE COMPANY 55 A.
ITEM 2. OFFER STATISTICS AND EXPECTED TIMETABLE 3 A. Offer statistics 3 B. Method and expected timetable 3 ITEM 3. KEY INFORMATION 3 A. [Reserved] 3 B. Capitalization and indebtedness 3 C. Reasons for the offer and use of proceeds 3 D. Risk factors 3 ITEM 4. INFORMATION ON THE COMPANY 56 A.

Item 3. Legal Proceedings

Legal Proceedings — active lawsuits and investigations

115 edited+27 added−11 removed606 unchanged
Biggest changeRisks related to intellectual property: ● We or our licensing or collaboration partners may not have sufficient patent terms to protect our products and business effectively, which may adversely affect our product sales and technology development. ● If we fail to comply with the obligations to obtain and maintain patent protection such as compliance with intellectual property agreements, including those under which we license intellectual property and other rights to or from third parties, or otherwise experience disruptions to our business relationships with our licensees, our 4 Table of Contents licensors and collaboration partners, we could lose intellectual property rights that are important to our business. ● We may be subject to claims challenging the inventorship of our patents and other intellectual property.
Biggest changeRisks related to our relationships with third parties: ● If we fail to maintain, or realize the benefits from, our current strategic relationships with our current and potential future license and collaboration partners our financial condition may be materially adversely affected. ● We may seek to form additional strategic alliances in the future with respect to our product candidates, and if we do not realize the benefits of such alliances, our business, financial condition, commercialization prospects and results of operations may be materially adversely affected. ● Our collaboration agreements may make us an attractive acquisition target under certain circumstances. 4 Table of Contents Risks related to intellectual property: ● We or our licensing or collaboration partners may not have sufficient patent terms to protect our products and business effectively, which may adversely affect our product sales and technology development. ● If we fail to comply with the obligations to obtain and maintain patent protection such as compliance with intellectual property agreements, including those under which we license intellectual property and other rights to or from third parties, or otherwise experience disruptions to our business relationships with our licensees, our licensors and collaboration partners, we could lose intellectual property rights that are important to our business. ● We may be subject to claims challenging the inventorship of our patents and other intellectual property.
The success of our current and future product candidates will depend on several factors, including, but not limited to, the following: ● completing preclinical and clinical studies that demonstrate the efficacy, safety and clinical utility of our preclinical and clinical product candidates; ● receiving marketing approvals from applicable regulatory authorities; ● establishing commercial manufacturing capabilities; ● launching commercial sales, marketing and distribution operations; ● acceptance of our product candidates by patients, the medical community and third-party payors; ● a continued acceptable safety profile following approval; ● competing effectively with other therapies or diagnostic approaches; and ● obtaining, maintaining, enforcing and defending our intellectual property rights and claims and not infringing on third parties’ intellectual property rights.
The success of our current and future product candidates will depend on several factors, including, but not limited to, the following: ● completing preclinical and clinical studies that demonstrate the efficacy, safety and clinical utility of our preclinical and clinical product candidates; ● receiving marketing approvals from applicable regulatory authorities; establishing commercial manufacturing capabilities and launching commercial sales, marketing and distribution operations; ● acceptance of our product candidates by patients, the medical community and third-party payors and a continued acceptable safety profile following approval; ● competing effectively with other therapies or diagnostic approaches; and ● obtaining, maintaining, enforcing and defending our intellectual property rights and claims and not infringing on third parties’ intellectual property rights.
Accordingly, our future results could be harmed by a variety of factors, including: ● economic weakness, including inflation, or political instability in particular non-U.S. economies and markets; ● differing regulatory requirements for drug approvals in non-U.S. countries; ● potentially reduced protection for intellectual property rights; ● difficulties in compliance with non-U.S. laws and regulations; ● changes in non-U.S. regulations and customs, tariffs and trade barriers; ● changes in non-U.S. currency exchange rates and currency controls; ● changes in a specific country’s or region’s political or economic environment; ● trade protection measures, import or export licensing requirements or other restrictive actions such as sanctions by U.S. or non-U.S. governments; ● negative consequences from changes in tax laws; ● compliance with tax, employment, immigration and labor laws for employees living or traveling abroad; ● workforce uncertainty in countries where labor unrest is more common than in the U.S.; ● difficulties associated with staffing and managing international operations, including differing labor relations; 13 Table of Contents ● production shortages resulting from any events affecting raw material supply or manufacturing capabilities abroad; and ● business interruptions resulting from geopolitical actions, including war and terrorism, or natural disasters including earthquakes, typhoons, floods and fires.
Accordingly, our future results could be harmed by a variety of factors, including: ● economic weakness, including inflation, or political instability in particular non-U.S. economies and markets; ● differing regulatory requirements for drug approvals in non-U.S. countries; ● potentially reduced protection for intellectual property rights; ● difficulties in compliance with non-U.S. laws and regulations; ● changes in non-U.S. regulations and customs, tariffs and trade barriers; ● changes in non-U.S. currency exchange rates and currency controls; ● changes in a specific country’s or region’s political or economic environment; ● trade protection measures, import or export licensing requirements or other restrictive actions such as sanctions by U.S. or non-U.S. governments; ● negative consequences from changes in tax laws; ● compliance with tax, employment, immigration and labor laws for employees living or traveling abroad; ● workforce uncertainty in countries where labor unrest is more common than in the U.S.; ● difficulties associated with staffing and managing international operations, including differing labor relations; ● production shortages resulting from any events affecting raw material supply or manufacturing capabilities abroad; and 13 Table of Contents ● business interruptions resulting from geopolitical actions, including war and terrorism, or natural disasters including earthquakes, typhoons, floods and fires.
As such, existing climate change-related requirements, and any more stringent requirements in the future, could increase our costs of sourcing, production, and transportation, increase our costs of compliance with disclosure and 15 Table of Contents reporting requirements, as well as have negative reputational impacts if we fail to meet such requirements, and could have a material adverse effect on our business, financial condition, results of operations and reputation.
As such, existing climate change-related requirements, and any more stringent requirements in the future, could increase our costs of sourcing, production, and transportation, 15 Table of Contents increase our costs of compliance with disclosure and reporting requirements, as well as have negative reputational impacts if we fail to meet such requirements, and could have a material adverse effect on our business, financial condition, results of operations and reputation.
The completion of clinical studies for our product candidates may be delayed, suspended or terminated as a result of many factors, including but not limited to: ● the delay or refusal of regulators or IRBs to authorize us to commence or amend a clinical study at a prospective study site or changes in regulatory requirements, policies and guidelines; ● delays or failure to reach agreement on acceptable terms with prospective CROs and clinical study sites, the terms of which can be subject to extensive negotiation and may vary significantly among different CROs and study sites; ● delays in patient enrollment and variability in the number and types of patients available for clinical studies; ● the inability to enroll a sufficient number of patients in studies to ensure adequate statistical power to detect statistically significant treatment effects; ● negative or inconclusive results, which may require us to conduct additional preclinical or clinical studies or to abandon projects that we expected to be promising; ● safety or tolerability concerns, which could cause us to suspend or terminate a study if we find that the participants are being exposed to unacceptable health risks; ● regulators or IRBs requiring that we or our investigators suspend or terminate clinical research for various reasons, including noncompliance with regulatory requirements or safety concerns, among others; ● lower than anticipated retention rates of patients and volunteers in clinical studies; ● our CROs or clinical study sites failing to comply with regulatory requirements or meet their contractual obligations to us in a timely manner, or at all, deviating from the protocol or dropping out of a study; ● delays relating to adding new clinical study sites; ● difficulty in maintaining contact with patients after treatment, resulting in incomplete data; ● delays in establishing the appropriate dosage levels; 40 Table of Contents ● the quality or stability of the product candidate falling below acceptable standards; ● the inability to produce or obtain sufficient quantities of the product candidate to complete clinical studies; and ● exceeding budgeted costs due to difficulty in accurately predicting costs associated with clinical studies.
The completion of clinical studies for our product candidates may be delayed, suspended or terminated as a result of many factors, including but not limited to: ● the delay or refusal of regulators or IRBs to authorize us to commence or amend a clinical study at a prospective study site or changes in regulatory requirements, policies and guidelines; ● delays or failure to reach agreement on acceptable terms with prospective CROs and clinical study sites, the terms of which can be subject to extensive negotiation and may vary significantly among different CROs and study sites; ● delays in patient enrollment and variability in the number and types of patients available for clinical studies; 40 Table of Contents ● the inability to enroll a sufficient number of patients in studies to ensure adequate statistical power to detect statistically significant treatment effects; ● negative or inconclusive results, which may require us to conduct additional preclinical or clinical studies or to abandon projects that we expected to be promising; ● safety or tolerability concerns, which could cause us to suspend or terminate a study if we find that the participants are being exposed to unacceptable health risks; ● regulators or IRBs requiring that we or our investigators suspend or terminate clinical research for various reasons, including noncompliance with regulatory requirements or safety concerns, among others; ● lower than anticipated retention rates of patients and volunteers in clinical studies; ● our CROs or clinical study sites failing to comply with regulatory requirements or meet their contractual obligations to us in a timely manner, or at all, deviating from the protocol or dropping out of a study; ● delays relating to adding new clinical study sites; ● difficulty in maintaining contact with patients after treatment, resulting in incomplete data; ● delays in establishing the appropriate dosage levels; ● the quality or stability of the product candidate falling below acceptable standards; ● the inability to produce or obtain sufficient quantities of the product candidate to complete clinical studies; and ● exceeding budgeted costs due to difficulty in accurately predicting costs associated with clinical studies.
In addition, many of the factors that cause, or lead to, a delay in the commencement or completion of clinical studies may also ultimately lead to the denial of regulatory approval of our product candidates.
In addition, many of the factors that cause, or lead to, a delay in the commencement or completion of clinical studies may also ultimately lead to the denial of regulatory approval of our product candidates.
The market price of our common shares may fluctuate significantly due to a variety of factors, including: ● positive or negative results of testing and clinical studies by us, strategic partners, or competitors; 46 Table of Contents ● delays in entering into strategic relationships with respect to development and/or commercialization of our product candidates or entry into strategic relationships on terms that are not deemed to be favorable to us; ● the sentiment of retail investors, including the perception of our clinical trial results by such retail investors, which investors may be subject to the influence of information provided by social media, third party investor websites and independent authors distributing information on the internet; ● technological innovations or commercial product introductions by us or our collaboration partners or competitors; ● changes in government regulations; ● developments concerning proprietary rights, including patents and litigation matters; ● public concern relating to the commercial value or safety of any of our product candidates; ● financing or other corporate transactions; ● publication of research reports or comments by securities or industry analysts or key opinion leaders; ● general market conditions in the pharmaceutical or biopharmaceutical industry or in the economy as a whole; or ● other events and factors beyond our control.
The market price of our common shares may fluctuate significantly due to a variety of factors, including: ● positive or negative results of testing and clinical studies by us, strategic partners, or competitors; ● delays in entering into strategic relationships with respect to development and/or commercialization of our product candidates or entry into strategic relationships on terms that are not deemed to be favorable to us; ● the sentiment of retail investors, including the perception of our clinical trial results by such retail investors, which investors may be subject to the influence of information provided by social media, third party investor websites and independent authors distributing information on the internet; ● technological innovations or commercial product introductions by us or our collaboration partners or competitors; 47 Table of Contents ● changes in government regulations; ● developments concerning proprietary rights, including patents and litigation matters; ● public concern relating to the commercial value or safety of any of our product candidates; ● financing or other corporate transactions; ● publication of research reports or comments by securities or industry analysts or key opinion leaders; ● general market conditions in the pharmaceutical or biopharmaceutical industry or in the economy as a whole; or ● other events and factors beyond our control.
For purposes of the above calculations, we will be treated as if we hold our proportionate share of the assets of, and directly receive our proportionate share of the income of, any other corporation in which we directly or indirectly own at least 25% of the shares of such corporation by value.
For purposes of the above calculations, we will generally be treated as if we hold our proportionate share of the assets of, and directly receive our proportionate share of the income of, any other corporation in which we directly or indirectly own at least 25% of the shares of such corporation by value.
Applications for our product candidates could fail to receive regulatory approval for many reasons, including but not limited to the following: ● the FDA, EMA or comparable foreign regulatory authorities may disagree with the design or implementation of our clinical studies; 38 Table of Contents ● the population studied in the clinical program may not be sufficiently broad or representative to assure safety in the full population for which we seek approval; ● the FDA, EMA or comparable foreign regulatory authorities may disagree with our interpretation of data from nonclinical or clinical studies; ● the data collected from clinical studies of our product candidates may not be sufficient to support the submission of an NDA or other submission or to obtain regulatory approval in the U.S. or elsewhere; ● we may be unable to demonstrate to the FDA, EMA or comparable foreign regulatory authorities that a product candidate’s benefit-risk ratio for its proposed indication is acceptable; ● the FDA, EMA or other regulatory authorities may fail to approve the manufacturing processes, test procedures and specifications, or facilities of third-party manufacturers with which we contract for clinical and commercial supplies; and ● the approval policies or regulations of the FDA, EMA or comparable foreign regulatory authorities may change significantly in a manner rendering our clinical data insufficient for approval.
Applications for our product candidates could fail to receive regulatory approval for many reasons, including but not limited to the following: ● the FDA, EMA or comparable foreign regulatory authorities may disagree with the design or implementation of our clinical studies; ● the population studied in the clinical program may not be sufficiently broad or representative to assure safety in the full population for which we seek approval; ● the FDA, EMA or comparable foreign regulatory authorities may disagree with our interpretation of data from nonclinical or clinical studies; ● the data collected from clinical studies of our product candidates may not be sufficient to support the submission of an NDA or other submission or to obtain regulatory approval in the U.S. or elsewhere; ● we may be unable to demonstrate to the FDA, EMA or comparable foreign regulatory authorities that a product candidate’s benefit-risk ratio for its proposed indication is acceptable; ● the FDA, EMA or other regulatory authorities may fail to approve the manufacturing processes, test procedures and specifications, or facilities of third-party manufacturers with which we contract for clinical and commercial supplies; and ● the approval policies or regulations of the FDA, EMA or comparable foreign regulatory authorities may change significantly in a manner rendering our clinical data insufficient for approval.
U.S. investors that own our common shares during any taxable year in which we are (or were) a PFIC generally will be subject to adverse U.S. federal income tax consequences, including (i) the treatment of all or a portion of any gain on 54 Table of Contents disposition of our common shares as ordinary income, (ii) the application of a deferred interest charge on such gain and the receipt of certain dividends and (iii) the requirement to file certain reports to the IRS.
U.S. investors that own our common shares during any taxable year in which we are (or were) a PFIC generally will be subject to adverse U.S. federal income tax consequences, including (i) the treatment of all or a portion of any gain on 55 Table of Contents disposition of our common shares as ordinary income, (ii) the application of a deferred interest charge on such gain and the receipt of certain dividends and (iii) the requirement to file certain reports to the IRS.
We may no longer be a foreign private issuer as of June 30, 2025 (or the end of our second fiscal quarter in any subsequent fiscal year), which would require us to comply with all of the periodic disclosure and current reporting requirements of the Exchange Act applicable to U.S. domestic issuers as of January 1, 2026 (or the first day of the fiscal year immediately succeeding the end of such second quarter).
We may no longer be a foreign private issuer as of June 30, 2026 (or the end of our second fiscal quarter in any subsequent fiscal year), which would require us to comply with all of the periodic disclosure and current reporting requirements of the Exchange Act applicable to U.S. domestic issuers as of January 1, 2027 (or the first day of the fiscal year immediately succeeding the end of such second quarter).
Disputes may arise regarding intellectual property subject to a licensing or co-ownership agreement, including: ● the scope of rights granted under the agreement, any restrictions in licensed fields and other interpretation-related issues; ● the extent to which our technology and processes infringe or otherwise violate the intellectual property of any third parties; ● the sublicensing of patents and other intellectual property rights; ● the diligence, development and commercialization obligations under the agreement and what activities satisfy those obligations; ● the ownership of inventions and know-how resulting from the joint or mutual creation or use of intellectual property by our licensors or collaboration partners and us; ● non-compete commitments; and ● consequences for changes in control.
Disputes may arise regarding intellectual property subject to a licensing or co-ownership agreement, including: ● the scope of rights granted under the agreement, any restrictions in licensed fields and other interpretation-related issues; ● the extent to which our technology and processes infringe or otherwise violate the intellectual property of any third parties; ● the sublicensing of patents and other intellectual property rights; 31 Table of Contents ● the diligence, development and commercialization obligations under the agreement and what activities satisfy those obligations; ● the ownership of inventions and know-how resulting from the joint or mutual creation or use of intellectual property by our licensors or collaboration partners and us; ● non-compete commitments; and ● consequences for changes in control.
This statute provides in principle that a judgment rendered by a non-Swiss court may be enforced in Switzerland only if: ● the non-Swiss court had jurisdiction pursuant to the Swiss Federal Act on Private International Law; ● the judgment of such non-Swiss court has become final and non-appealable; ● the judgment does not contravene Swiss public policy; ● the court procedures and the service of documents leading to the judgment were in accordance with the due process of law; and 50 Table of Contents ● no proceeding involving the same parties and the same subject matter was first brought in Switzerland, or adjudicated in Switzerland, or was earlier adjudicated in a third state for which the decision is recognizable in Switzerland.
This statute provides in principle that a judgment rendered by a non-Swiss court may be enforced in Switzerland only if: ● the non-Swiss court had jurisdiction pursuant to the Swiss Federal Act on Private International Law; ● the judgment of such non-Swiss court has become final and non-appealable; ● the judgment does not contravene Swiss public policy; ● the court procedures and the service of documents leading to the judgment were in accordance with the due process of law; and ● no proceeding involving the same parties and the same subject matter was first brought in Switzerland, or adjudicated in Switzerland, or was earlier adjudicated in a third state for which the decision is recognizable in Switzerland.
If one or more of these analysts cease coverage of our company or fail to publish reports on us regularly, demand for our common shares could decrease, which might cause the price of our common shares and trading volume to decline. ​ 53 Table of Contents We were likely a passive foreign investment company (a “PFIC”) for certain of our previous taxable years.
If one or more of these analysts cease coverage of our company or fail to publish reports on us regularly, demand for our common shares could decrease, which might cause the price of our common shares and trading volume to decline. ​ 54 Table of Contents We were likely a passive foreign investment company (a “PFIC”) for certain of our previous taxable years.
In accordance with the terms of the Sales Agreement, we may offer and sell our common shares having an aggregate offering price up to USD 80.0 (CHF 73.0) million from time to time through Jefferies LLC, acting as our sales agent. We do not have any material committed external source of funds.
In accordance with the terms of the Sales Agreement, we may offer and sell our common shares having an aggregate offering price up to USD 80.0 (CHF 64.0) million from time to time through Jefferies LLC, acting as our sales agent. We do not have any material committed external source of funds.
Although we have not obtained valuations of our assets (including goodwill or going concern value) for 2024 and thus are not in a position to make a definitive determination regarding whether we were a PFIC for 2024, based on the composition of our income and assets during 2024 and the estimated value of our assets (which is based on our average market capitalization during 2024), we believe that we were likely not a PFIC for 2024.
Although we have not obtained valuations of our assets (including goodwill or going concern value) for 2025 and thus are not in a position to make a definitive determination regarding whether we were a PFIC for 2025, based on the composition of our income and assets during 2025 and the estimated value of our assets (which is based on our average market capitalization during 2025), we believe that we were likely not a PFIC for 2025.
In response to a public health crisis, governments, public institutions, and other organizations in countries and localities may take certain preventative or protective measures to combat the transmission of the virus, including the implementation of travel restrictions or bans, closures of non-essential businesses, limitations of public gatherings, other social distancing and shelter-in-place measures, and delays or cancellations of elective surgeries.
In response to a public health crisis, governments, public institutions, and other organizations in countries and localities may take certain preventative or protective measures to combat the transmission of a disease, including the implementation of travel restrictions or bans, closures of non-essential businesses, limitations of public gatherings, other social distancing and shelter-in-place measures, and delays or cancellations of elective surgeries.
If our relationships with Lilly, Janssen, LMI, Takeda or other of our current or future strategic partners were to deteriorate substantially or if Lilly, Janssen, LMI, Takeda or other of our current or future strategic partners were to challenge our use of their intellectual property or our calculations of the payments which are owed under our agreements, our business, financial condition, commercialization prospects and results of operations could be materially adversely affected.
If our relationships with Lilly, Janssen, Lantheus, Takeda or other of our current or future strategic partners were to deteriorate substantially or if Lilly, Janssen, Lantheus, Takeda or other of our current or future strategic partners were to challenge our use of their intellectual property or our calculations of the payments which are owed under our agreements, our business, financial condition, commercialization prospects and results of operations could be materially adversely affected.
Lastly, our collaboration agreements with Lilly, Janssen, LMI and Takeda (in the case of Takeda, if it exercises its option under our agreement) provide each partner with control over, and responsibility for, the clinical development process, including obtaining regulatory and marketing approvals, manufacturing costs and sales and marketing costs. Future collaboration agreements may also relinquish development control to our partners.
Lastly, our collaboration agreements with Lilly, Janssen, Lantheus and Takeda (in the case of Takeda, if it exercises its option under our agreement) provide each partner with control over, and responsibility for, the clinical development process, including obtaining regulatory and marketing approvals, manufacturing costs and sales and marketing costs. Future collaboration agreements may also relinquish development control to our partners.
Therefore, in addition to our relationships with Lilly, Janssen, LMI and Takeda, we may decide to enter into strategic alliances or to create joint ventures or collaborations with pharmaceutical or biopharmaceutical companies for the further development and potential commercialization of those and other of our product candidates. We face significant competition in seeking appropriate collaborators.
Therefore, in addition to our relationships with Lilly, Janssen, Lantheus and Takeda, we may decide to enter into strategic alliances or to create joint ventures or collaborations with pharmaceutical or biopharmaceutical companies for the further development and potential commercialization of those and other of our product candidates. We face significant competition in seeking appropriate collaborators.
HIPAA imposes criminal and civil liability for executing a scheme to defraud any healthcare benefit program or making false statements relating to healthcare matters; ● the HIPAA, as amended by the Health Information Technology for Economic and Clinical Health Act, imposes obligations, including mandatory contractual terms, with respect to safeguarding the privacy, security and transmission of individually identifiable health information; ● the transparency requirements under the Health Care Reform Law require manufacturers of drugs, devices, biologics and medical supplies to report to the U.S.
HIPAA imposes criminal and civil liability for executing a scheme to defraud any healthcare benefit program or making false statements relating to healthcare matters; ● the HIPAA, as amended by the Health Information Technology for Economic and Clinical Health Act, imposes obligations, including mandatory contractual terms, with respect to safeguarding the privacy, security and transmission of individually identifiable health information; 45 Table of Contents ● the transparency requirements under the Health Care Reform Law require manufacturers of drugs, devices, biologics and medical supplies to report to the U.S.
In addition, if the FDA or a comparable foreign regulatory authority approves any of our product 41 Table of Contents candidates, we will be subject to ongoing regulatory obligations and oversight by regulatory authorities, including with respect to the manufacturing processes, labeling, packing, distribution, adverse event reporting, storage, advertising and marketing restrictions, and record-keeping and, potentially, other post-marketing obligations, all of which may result in significant expense and limit our or our collaboration partners’ ability to commercialize such products.
In addition, if the FDA or a comparable foreign regulatory authority approves any of our product candidates, we will be subject to ongoing regulatory obligations and oversight by regulatory authorities, including with respect to the manufacturing processes, labeling, packing, distribution, adverse event reporting, storage, advertising and marketing restrictions, and record-keeping and, potentially, other post-marketing obligations, all of which may result in significant expense and limit our or our collaboration partners’ ability to commercialize such products.
However, for the reasons described above there can be no assurance that the IRS will agree. Because our PFIC status is a factual annual determination that can be determined only after the end of the relevant taxable year, we cannot express a view regarding our PFIC status for 2025 or any future taxable year.
However, for the reasons described above there can be no assurance that the IRS will agree. Because our PFIC status is a factual annual determination that can be determined only after the end of the relevant taxable year, we cannot express a view regarding our PFIC status for 2026 or any future taxable year.
The rights of our shareholders may be different from the rights of shareholders in companies governed by the laws of U.S. jurisdictions. ● We are an FPI and, as a result, we are not subject to U.S. proxy rules and are subject to Exchange Act reporting obligations that, to some extent, are more lenient and less frequent than those of a U.S. domestic public company. ● As an FPI, and as permitted by the listing requirements of Nasdaq, we rely on certain home country governance practices rather than the corporate governance requirements of Nasdaq.
The rights of our shareholders may be different from the rights of shareholders in companies governed by the laws of U.S. jurisdictions. ● We are an FPI and, as a result, we are not subject to U.S. proxy rules and are subject to Exchange Act reporting obligations that, to some extent, are more lenient and less frequent than those of a U.S. domestic public company. 5 Table of Contents ● As an FPI, and as permitted by the listing requirements of Nasdaq, we rely on certain home country governance practices rather than the corporate governance requirements of Nasdaq.
We also have a diagnostic partnership with LMI for compounds, which bind pathological Tau for use as a PET tracer. In May 2024, we entered into a worldwide option and license agreement with Takeda for our active immunotherapies targeting Abeta, including ACI-24.060.
We also have a diagnostic partnership with Lantheus for compounds, which bind pathological Tau for use as a PET tracer. In May 2024, we entered into a worldwide option and license agreement with Takeda for our active immunotherapies targeting Abeta, including ACI-24.060.
If Lilly, Janssen, LMI, Takeda or other of our current or future strategic partners terminate their agreement with us at any time, it could delay or prevent development of our product candidates and materially harm our business, financial condition, commercialization prospects and results of operations.
If Lilly, Janssen, Lantheus, Takeda or other of our current or future strategic partners terminate their agreement with us at any time, it could delay or prevent development of our product candidates and materially harm our business, financial condition, commercialization prospects and results of operations.
In September 2020, the Company established an “at the market offering” (ATM) for the sale of up to USD 80.0 (CHF 73.0) million worth of our common shares from time to time by entering into an Open Market Sale Agreement (Sales Agreement) with Jefferies LLC (Jefferies).
In September 2020, the Company established an “at the market offering” (ATM) for the sale of up to USD 80.0 (CHF 64.0) million worth of our common shares from time to time by entering into an Open Market Sale Agreement (Sales Agreement) with Jefferies LLC (Jefferies).
Although we try to ensure that our employees, consultants, and independent contractors do not use the proprietary information or know-how of others in their work for us, we may be subject to claims that we or our employees, consultants or independent contractors have inadvertently or otherwise used or disclosed intellectual property, including trade secrets or other proprietary information, of any of our employees’, consultants’ or independent contractors’ former employers or of other third parties.
Although we try to ensure that our employees, consultants, and independent contractors do not use the proprietary information or know-how of others in their work for us, we may be subject to claims that we or our employees, 33 Table of Contents consultants or independent contractors have inadvertently or otherwise used or disclosed intellectual property, including trade secrets or other proprietary information, of any of our employees’, consultants’ or independent contractors’ former employers or of other third parties.
We expect the aggregate of the reserves from capital contributions confirmed by the Swiss Federal Tax Administration and share capital, less the total losses brought forward (to the extent set off against reserves 49 Table of Contents from capital contributions or share capital), less the treasury shares (to the extent booked against reserves from capital contributions), less the lowest legally possible issued share capital and legal reserve to represent the maximum amount potentially available for future dividends or capital reductions on a Swiss withholding tax-free basis.
We expect the aggregate of the reserves from capital contributions confirmed by the Swiss Federal Tax Administration and share capital, less the total losses brought forward (to the extent set off against reserves from capital contributions or share capital), less the treasury shares (to the extent booked against reserves from capital contributions), less the lowest legally possible issued share capital and legal reserve to represent the maximum amount potentially available for future dividends or capital reductions on a Swiss withholding tax-free basis.
Although we believe we were likely not a PFIC for 2024, there can be no assurance that the Internal Revenue Service will agree. We cannot express any expectation regarding our PFIC status for 2025 or future taxable years.
Although we believe we were likely not a PFIC for 2025, there can be no assurance that the Internal Revenue Service will agree. We cannot express any expectation regarding our PFIC status for 2026 or future taxable years.
To the extent the Company introduces the capital band in 2025, only net proceeds from capital increase using the capital band (less certain expenses and net of repayments from the Company) will be recognized as reserves from capital contributions at the end of validity period of the respective capital band).
To the extent the Company introduces the capital band in 2026, only net proceeds from capital increase using the capital band (less certain expenses and net of repayments from the Company) will be recognized as reserves from capital contributions at the end of validity period of the respective capital band.
If granted, Fast Track designation makes a product eligible for more frequent interactions with the FDA to discuss the development plan and clinical trial design, as well as rolling review of the application, which means that the company can submit completed sections of its marketing application for review prior to completion of the entire submission.
If granted, Fast Track designation makes a 9 Table of Contents product eligible for more frequent interactions with the FDA to discuss the development plan and clinical trial design, as well as rolling review of the application, which means that the company can submit completed sections of its marketing application for review prior to completion of the entire submission.
Any of these effects could damage our reputation, result in the loss of valuable property and information, cause us to breach applicable laws and regulations, or otherwise adversely impact our business. Risks related to our financial condition and capital requirements We are a clinical-stage company and have a history of operating losses.
Any of these effects could damage our reputation, result in the loss of valuable property and information, cause us to breach applicable laws and regulations, or otherwise adversely impact our business. 35 Table of Contents Risks related to our financial condition and capital requirements We are a clinical-stage company and have a history of operating losses.
These rules and regulations could also make it more difficult for us to attract and retain qualified members of our board of directors. If we fail to maintain an effective system of internal control over financial reporting, we may not be able to accurately report our financial results or prevent fraud.
These rules and regulations could also make it more difficult for us to attract and retain qualified members of our board of directors. 53 Table of Contents If we fail to maintain an effective system of internal control over financial reporting, we may not be able to accurately report our financial results or prevent fraud.
If the actual market for our product candidates is smaller than we expect, or if any approved products fail to achieve an adequate level of acceptance by physicians, healthcare payors and patients, our product or royalty revenue may be limited and it may be more difficult for us to achieve or maintain profitability.
If 10 Table of Contents the actual market for our product candidates is smaller than we expect, or if any approved products fail to achieve an adequate level of acceptance by physicians, healthcare payors and patients, our product or royalty revenue may be limited and it may be more difficult for us to achieve or maintain profitability.
If we are slow or unable to adapt to changes in existing requirements or the adoption of new requirements or policies, or if we are not able to maintain regulatory compliance, we may lose any marketing approval that we may have obtained, which would adversely affect our business, prospects and ability to achieve or sustain profitability.
If we are slow or unable to adapt to changes in existing requirements or the adoption of new 42 Table of Contents requirements or policies, or if we are not able to maintain regulatory compliance, we may lose any marketing approval that we may have obtained, which would adversely affect our business, prospects and ability to achieve or sustain profitability.
If the number of our addressable patients is not as significant as we estimate, the indication approved by regulatory authorities is narrower than we expect, the treatment population is narrowed by competition, physician choice or treatment 36 Table of Contents guidelines or other commercial related factors we may not generate significant revenue from sales of such products, even if approved.
If the number of our addressable patients is not as significant as we estimate, the indication approved by regulatory authorities is narrower than we expect, the treatment population is narrowed by competition, physician choice or treatment guidelines or other commercial related factors we may not generate significant revenue from sales of such products, even if approved.
For an IPR&D asset, the risk of failure is significant, and there can be no certainty that the asset will become a successful candidate. Our ability to realize value on this significant investment is often contingent upon, among other things, regulatory approvals and market acceptance.
For an IPR&D asset, the risk of failure is significant, and there can be no certainty that the asset will become a successful candidate. Our ability to realize value on this significant investment is often contingent upon, among other things, regulatory approvals and 38 Table of Contents market acceptance.
If we or one of our licensing or collaboration partners were to initiate legal proceedings against a third party to enforce a patent covering one of our product candidates, the defendant could counterclaim that the patent covering our product candidate is invalid or unenforceable or that the defendant’s products do not infringe our or our licensing collaborators’ patents or that we or our licensing collaborators infringe the defendant’s patents.
If we or one of our licensing or collaboration partners were to initiate legal proceedings against a third party to enforce a patent covering one of our product candidates, the defendant could counterclaim that the patent covering our product candidate is invalid or unenforceable or that the defendant’s products do not infringe our or our licensing collaborators’ 26 Table of Contents patents or that we or our licensing collaborators infringe the defendant’s patents.
While it is not clear at this time how these legislative and regulatory initiatives will affect our ability to pursue accelerated approval for any of our product candidates, these developments may have a material adverse impact on our business, financial condition, and results of operations.
While it is not clear at this time how these legislative and regulatory initiatives will affect our ability to pursue accelerated approval for any of our 39 Table of Contents product candidates, these developments may have a material adverse impact on our business, financial condition, and results of operations.
It is possible that some of these parties will have interests that are different from, or in addition to, your interests as a shareholder. Swiss corporate law limits the ability of our shareholders to challenge resolutions made or other actions taken by our board of 48 Table of Contents directors in court.
It is possible that some of these parties will have interests that are different from, or in addition to, your interests as a shareholder. Swiss corporate law limits the ability of our shareholders to challenge resolutions made or other actions taken by our board of directors in court.
Our board of directors therefore may include fewer independent directors than would be required if we were subject to Nasdaq Listing Rule 5605(b)(1). In addition, we are not subject to Nasdaq Listing Rule 5605(b)(2), which requires that independent directors regularly have scheduled meetings at which only independent directors are present.
Our board of directors therefore may include fewer independent directors than would be required if we were subject to Nasdaq Listing Rule 5605(b)(1). In addition, we are not subject to Nasdaq 52 Table of Contents Listing Rule 5605(b)(2), which requires that independent directors regularly have scheduled meetings at which only independent directors are present.
In June 2023, we amended our code of conduct, but it is not always possible to identify and deter employee misconduct, and the precautions we take to detect and prevent this activity may not be effective in controlling unknown or unmanaged risks or losses or in protecting us from governmental investigations or other actions or lawsuits stemming from a failure to comply with these laws or regulations.
In October 2025, we amended our code of conduct, but it is not always possible to identify and deter employee misconduct, and the precautions we take to detect and prevent this activity may not be effective in controlling unknown or unmanaged risks or losses or in protecting us from governmental investigations or other actions or lawsuits stemming from a failure to comply with these laws or regulations.
We have received Fast Track designation for ACI-24.060, ACI-35.030 and PI- 9 Table of Contents 2620 and we may also seek Fast Track designation for certain of our future product candidates, but there is no assurance that the FDA will grant this status to any of our future product candidates.
We have received Fast Track designation for ACI-24.060, ACI-35.030 and PI-2620 and we may also seek Fast Track designation for certain of our future product candidates, but there is no assurance that the FDA will grant this status to any of our future product candidates.
We expect our research and development expenses to continue to increase in connection with our ongoing activities, particularly as we and/or our collaboration partners continue our ongoing studies and initiate new studies of ACI-35.030, ACI-24.060, ACI-7104.056, Morphomer Tau, PI-2620 and ACI-12589 and initiate preclinical and clinical development of our other product candidates.
We expect our research and development expenses to continue to increase in connection with our ongoing activities, particularly as we and/or our collaboration partners continue our ongoing studies and initiate new studies of ACI-35.030, ACI-24.060, ACI-7104.056, and Morphomer Tau, and initiate preclinical and clinical development of our other product candidates.
Congress, 28 Table of Contents the federal courts and the USPTO could cause the laws and regulations governing patents to change in unpredictable ways. Any of the foregoing could harm our business, financial condition and results of operations. In Europe, the Unified Patent Court (UPC) entered into force in June 2023.
Congress, the federal courts and the USPTO could cause the laws and regulations governing patents to change in unpredictable ways. Any of the foregoing could harm our business, financial condition and results of operations. In Europe, the Unified Patent Court (UPC) entered into force in June 2023.
Further, beginning in 2011, the Health Care Reform Law imposed a significant annual fee on companies that manufacture or import branded prescription drug products. Legislative and regulatory proposals have been introduced at both the state and federal level to expand post-approval requirements and restrict sales and promotional activities for pharmaceutical products.
Further, beginning in 2011, the Health Care Reform Law imposed a significant annual fee on companies that manufacture or import branded prescription drug 43 Table of Contents products. Legislative and regulatory proposals have been introduced at both the state and federal level to expand post-approval requirements and restrict sales and promotional activities for pharmaceutical products.
The use of certain AI technology can give rise to intellectual property risks, including compromises to intellectual property and proprietary information as well as intellectual property infringement and misappropriation. Other known risks of AI currently include inaccuracy, bias, toxicity, data privacy and cybersecurity issues, and data 34 Table of Contents provenance disputes.
The use of certain AI technology can give rise to intellectual property risks, including compromises to intellectual property and proprietary information as well as intellectual property infringement and misappropriation. Other known risks of AI currently include inaccuracy, bias, toxicity, data privacy and cybersecurity issues, and data provenance disputes.
Among other consequences, this concentration of ownership may have the effect of delaying or preventing a change in control and might therefore negatively affect the market price of our common shares. 47 Table of Contents Future sales, or the possibility of future sales, of a substantial number of our common shares could adversely affect the price of our common shares.
Among other consequences, this concentration of ownership may have the effect of delaying or preventing a change in control and might therefore negatively affect the market price of our common shares. Future sales, or the possibility of future sales, of a substantial number of our common shares could adversely affect the price of our common shares.
Foreign private issuers are also exempt from the Regulation Fair Disclosure, aimed at preventing issuers from making selective disclosures of material information. As a 51 Table of Contents result of the above, you may not have the same protections afforded to shareholders of companies that are not foreign private issuers.
Foreign private issuers are also exempt from the Regulation Fair Disclosure, aimed at preventing issuers from making selective disclosures of material information. As a result of the above, you may not have the same protections afforded to shareholders of companies that are not foreign private issuers.
On January 17, 2025, HHS announced 15 additional drugs selected for Medicare pricing negotiations, and 43 Table of Contents these negotiations with participating drug companies are slated to occur in 2025, with any negotiated prices becoming effective in 2027. Several manufacturers and industry groups have challenged the drug price negotiation program for Medicare Parts B and D in federal court.
On January 17, 2025, HHS announced 15 additional drugs selected for Medicare pricing negotiations, and these negotiations with participating drug companies are slated to occur in 2025, with any negotiated prices becoming effective in 2027. Several manufacturers and industry groups have challenged the drug price negotiation program for Medicare Parts B and D in federal court.
(Janssen) part of the Janssen Pharmaceutical Companies of Johnson & Johnson, Life Molecular Imaging SA (LMI), Takeda Pharmaceuticals, USA, Inc. (Takeda) and other of our current or future strategic partners, our business, commercialization prospects and financial condition may be materially adversely affected.
(Janssen) part of the Janssen Pharmaceutical Companies of Johnson & Johnson, Lantheus Holdings, Inc. (Lantheus, formerly Life Molecular Imaging SA or LMI), Takeda Pharmaceuticals, USA, Inc. (Takeda) and other of our current or future strategic partners, our business, commercialization prospects and financial condition may be materially adversely affected.
Such improper actions could subject us to civil or criminal investigations, and monetary and injunctive penalties, and could adversely impact our operating results, our ability to conduct business and our reputation. We are exposed to the risk of employee fraud or other misconduct.
Such improper actions could subject us to civil or criminal investigations, and monetary and injunctive penalties, and could adversely impact our operating results, our ability to conduct business and our reputation. 46 Table of Contents We are exposed to the risk of employee fraud or other misconduct.
We employ reputable law firms and other professionals to help us comply with these requirements and we are also dependent on our licensors or collaboration partners to take the necessary action to comply with these requirements with respect to certain of our intellectual property.
We employ 30 Table of Contents reputable law firms and other professionals to help us comply with these requirements and we are also dependent on our licensors or collaboration partners to take the necessary action to comply with these requirements with respect to certain of our intellectual property.
False Claims Act imposes criminal and civil penalties, including civil whistleblower or qui tam actions, against individuals or entities for knowingly presenting, or causing to be presented, to the U.S. 44 Table of Contents government, claims for payment that are false or fraudulent or making a false statement to avoid, decrease or conceal an obligation to pay money to the federal government; ● the U.S.
False Claims Act imposes criminal and civil penalties, including civil whistleblower or qui tam actions, against individuals or entities for knowingly presenting, or causing to be presented, to the U.S. government, claims for payment that are false or fraudulent or making a false statement to avoid, decrease or conceal an obligation to pay money to the federal government; ● the U.S.
Austerity measures in certain European nations may also affect the prices we are able to seek if our products are approved. Both in the U.S. and in the EU, legislative and regulatory proposals have been made to expand post-approval requirements and restrict sales and promotional activities for pharmaceutical and biopharmaceutical products.
Austerity measures in certain European nations may also affect the prices we are able to seek if our products are approved. Both in the U.S. and in the EU, legislative and regulatory proposals have been made to expand post-approval requirements and restrict 44 Table of Contents sales and promotional activities for pharmaceutical and biopharmaceutical products.
For example, the payment of dividends and cancellation of treasury shares must be approved by shareholders. Swiss law also requires that our shareholders themselves resolve, or authorize our board of directors, to increase our share capital.
For example, the payment of dividends and cancellation of treasury shares must be approved by shareholders. Swiss law also requires that our shareholders themselves resolve, or authorize our 51 Table of Contents board of directors, to increase our share capital.
Good relationships with Lilly, Janssen, LMI, Takeda and other of our current or future strategic partners are important for our business prospects.
Good relationships with Lilly, Janssen, Lantheus, Takeda and other of our current or future strategic partners are important for our business prospects.
If we receive regulatory approval for our current and future product candidates, and if we have not already licensed such product candidate to a collaboration partner and choose to commercialize such product candidate independently, we expect to incur significant commercialization expenses related to product manufacturing, sales, marketing, distribution and establishing a regulatory structure, depending on where we choose to commercialize.
If we receive regulatory approval for our current and future product candidates, and if we have not already licensed such product candidate to a collaboration partner and choose to commercialize such product candidate independently, we expect to incur significant commercialization expenses related to product manufacturing, sales, marketing, distribution 37 Table of Contents and establishing a regulatory structure, depending on where we choose to commercialize.
Certain principal shareholders as well as our executive officers and directors together beneficially own approximately 60.5% of our common shares. Depending on the level of attendance at our general meetings of shareholders, these shareholders may be in a position to determine the outcome of decisions taken at any such general meeting.
Certain principal shareholders as well as our executive officers and directors together beneficially own approximately 59.3% of our common shares. Depending on the level of attendance at our general meetings of shareholders, these shareholders may be in a position to determine the outcome of decisions taken at any such general meeting.
These assumptions involve the exercise of significant judgment on the part of our management and are inherently uncertain, and the reasonableness of these assumptions could 10 Table of Contents not have been assessed by an independent source in every detail.
These assumptions involve the exercise of significant judgment on the part of our management and are inherently uncertain, and the reasonableness of these assumptions could not have been assessed by an independent source in every detail.
In particular, Lilly, Janssen, Takeda or our other licensing or collaboration partners may be dependent on a license with a third party for the development and future commercialization of our product candidates.
In particular, Lilly, 27 Table of Contents Janssen, Takeda or our other licensing or collaboration partners may be dependent on a license with a third party for the development and future commercialization of our product candidates.
The pending or future patent applications that we own, co-own or in-license may fail to issue, fail to result in issued patents with claims that cover our product candidates in the U.S. or in other foreign countries, or fail to effectively prevent others from 27 Table of Contents commercializing competitive technologies and product candidates.
The pending or future patent applications that we own, co-own or in-license may fail to issue, fail to result in issued patents with claims that cover our product candidates in the U.S. or in other foreign countries, or fail to effectively prevent others from commercializing competitive technologies and product candidates.
We may not be able to protect our rights to these trademarks and trade names, which we need to build name recognition among potential partners or customers in our markets of interest.
We may not be able to protect 34 Table of Contents our rights to these trademarks and trade names, which we need to build name recognition among potential partners or customers in our markets of interest.
Our ability to generate future revenue from product sales depends heavily on our and our collaboration partners’ success in many areas, including but not limited to: ● successfully completing research and clinical development of our product candidates, by us or our collaboration partners, as the case may be; ● obtaining marketing approvals for our clinical product candidates, including our active immunotherapies (ACI-35.030, ACI-24.060 and ACI-7104.056) and diagnostics (Tau-PET tracer PI-2620, a-syn-PET tracers ACI-12589 and ACI-15916 and TDP-43-PET tracer ACI-19626), for which we or our collaboration partners complete clinical studies; ● developing a sustainable and scalable manufacturing process for any approved product candidates, and maintaining supply and manufacturing relationships with third parties that can conduct the process and provide adequate (in amount, quality and time) products to support clinical development and the market demand for our product candidates, if approved; ● launching and commercializing product candidates for which we obtain marketing approval, either directly or with a collaborator or distributor; ● obtaining market acceptance of our product candidates as viable treatment or diagnostic options; ● addressing any competing technological and market developments; ● identifying, assessing, acquiring and/or developing new product candidates; ● negotiating favorable terms in any collaboration, licensing, or other similar arrangements into which we may enter; ● maintaining, protecting, acquiring and expanding our portfolio of intellectual property rights, including patents, trade secrets and know-how; and ● attracting, hiring and retaining qualified personnel.
Our ability to generate future revenue from product sales depends heavily on our and our collaboration partners’ success in many areas, including but not limited to: ● successfully completing research and clinical development of our product candidates, by us or our collaboration partners, as the case may be; ● obtaining marketing approvals for our clinical product candidates, including our active immunotherapies (ACI-35.030, ACI-24.060 and ACI-7104.056), our small molecule drugs (ACI-19764 NLRP3 inhibitor, Morphomer-Tau, and Morphomer-a-syn), and diagnostics including Tau-PET tracer PI-2620, for which we or our collaboration partners complete clinical studies; ● developing a sustainable and scalable manufacturing process for any approved product candidates, and maintaining supply and manufacturing relationships with third parties that can conduct the process and provide adequate (in amount, quality and time) products to support clinical development and the market demand for our product candidates, if approved; ● launching and commercializing product candidates for which we obtain marketing approval, either directly or with a collaborator or distributor; ● obtaining market acceptance of our product candidates as viable treatment or diagnostic options; 36 Table of Contents ● addressing any competing technological and market developments; ● identifying, assessing, acquiring and/or developing new product candidates; ● negotiating favorable terms in any collaboration, licensing, or other similar arrangements into which we may enter; ● maintaining, protecting, acquiring and expanding our portfolio of intellectual property rights, including patents, trade secrets and know-how; and ● attracting, hiring and retaining qualified personnel.
These shares were registered pursuant to the registration statement on Form S-8 that we filed with the SEC and, therefore, can be freely sold in the public market upon issuance, subject to volume limitations applicable to affiliates.
These shares were registered pursuant to the registration statement on Form S-8 that we 48 Table of Contents filed with the SEC and, therefore, can be freely sold in the public market upon issuance, subject to volume limitations applicable to affiliates.
Such an outcome could have a material adverse effect on our business. Even if we are successful in defending against such claims, litigation could result in substantial costs and be a distraction to management and other employees.
Such an outcome could have a material adverse effect on our business. 28 Table of Contents Even if we are successful in defending against such claims, litigation could result in substantial costs and be a distraction to management and other employees.
As of the date hereof, certain principal shareholders controlling 5% or more of our common shares as well as our executive officers and directors together beneficially own approximately 60.5% of our common shares.
As of the date hereof, certain principal shareholders controlling 5% or more of our common shares as well as our executive officers and directors together beneficially own approximately 59.3% of our common shares.
Consequently, we may not be able to prevent third parties from practicing our inventions in all countries outside the U.S., or from selling or importing products made using our inventions in and into 33 Table of Contents the U.S. or other jurisdictions.
Consequently, we may not be able to prevent third parties from practicing our inventions in all countries outside the U.S., or from selling or importing products made using our inventions in and into the U.S. or other jurisdictions.
For example, we are aware of third-party patents or patent applications that may be construed to cover one or more of our product candidates.
For example, we are aware of third-party patents or patent 32 Table of Contents applications that may be construed to cover one or more of our product candidates.
There can be no assurance that Swiss law will not change in the future in a way detrimental to shareholders or that it will serve to protect investors in a similar fashion afforded under corporate law principles in the U.S., which could adversely affect the rights of investors.
We are organized under the laws of Switzerland. There can be no assurance that Swiss law will not change in the future in a way detrimental to shareholders or that it will serve to protect investors in a similar fashion afforded under corporate law principles in the U.S., which could adversely affect the rights of investors.
Even if 25 Table of Contents patents covering our product candidates are obtained and unchallenged, once the patent life has expired for a product, we may be open to competition from generic medications.
Even if patents covering our product candidates are obtained and unchallenged, once the patent life has expired for a product, we may be open to competition from generic medications.
Because we rely on our advisors, employees and third-party contractors and consultants to research and develop and to manufacture our product candidates, we must, at times, share our intellectual property with them.
Because we rely on our advisors, employees and third-party contractors and consultants to research and develop and to manufacture our product 29 Table of Contents candidates, we must, at times, share our intellectual property with them.
Members of our key management include Andrea Pfeifer, Ph.D., our Chief Executive Officer; Anke Post, M.D., Ph.D., our Chief Medical Officer; Christopher Roberts, our Chief Financial Officer; Piergiorgio Donati, our Chief Technical Operations Officer; Howard Donovan, our Chief Human Resources Officer; Mark Danton, our Executive Vice President (EVP) EVP Artificial Intelligence and Information Systems; Günther Staffler, Ph.D., our Senior Vice President (SVP) Immunotherapy; Julien Rongère, Ph.D., our SVP for Regulatory Affairs and Quality Assurance; Gary Waanders, Ph.D., our SVP Investor Relations and Corporate Communications; Matthias Maurer, Ph.D., our SVP General Counsel; Bojana Portmann, Ph.D., our Vice President (VP) for Intellectual Property and Business Development (VP IP and BD); Olivier Sol, M.D., our VP Head of Clinical Development; and Francesca Capotosti, Ph.D., our VP Research.
Members of our key management include Andrea Pfeifer, Ph.D., our Chief Executive Officer; Christopher Roberts, our Chief Financial Officer; Piergiorgio Donati, our Chief Technical Operations Officer; Mark Danton, our Executive Vice President (EVP) EVP Artificial Intelligence and Information Systems; Günther Staffler, Ph.D., our EVP Development; Francesca Capotosti, Ph.D., our VP Research; Julien Rongère, Ph.D., our SVP for Regulatory Affairs and Quality Assurance; Gary Waanders, Ph.D., our SVP Investor Relations and Corporate Communications; Matthias Maurer, Ph.D., our SVP General Counsel; Bojana Portmann, Ph.D., our Vice President (VP) for Intellectual Property and Business Development (VP IP and BD); and Olivier Sol, M.D., our VP, Clinical Safety Officer.
Data Bridge and on August 14, 2024 by the new Data Privacy Framework between Switzerland and the U.S. adding the U.S. to the list of countries with an adequate level of data protection), such decision does not foreclose, and is likely to face, future legal challenges and ongoing legal uncertainty.
Data Bridge and on August 14, 2024 by the new Data Privacy Framework between Switzerland and the U.S. adding the U.S. to the list of countries with an adequate level of data protection), such decision has faced, and is likely to face, in the future, legal challenges and ongoing legal uncertainty.
As of December 31, 2024, we reported tax loss carry-forwards from financial years 2018 until 2024 for purposes of Swiss corporate income tax in the aggregate amount of CHF 343.6 million, which could be available to offset future taxable income. If not used, these tax losses will expire 7 years after the year in which they were incurred.
As of December 31, 2025, we reported tax loss carry-forwards from financial years 2019 until 2025 for purposes of Swiss corporate income tax in the aggregate amount of CHF 362.3 million, which could be available to offset future taxable income. If not used, these tax losses will expire 7 years after the year in which they were incurred.
Although we believe we were likely not a PFIC for 2024, there can be no assurance that the Internal Revenue Service will agree. We cannot express any expectation regarding our PFIC status for 2025 or future taxable 5 Table of Contents years.
Although we believe we were likely not a PFIC for 2025, there can be no assurance that the Internal Revenue Service will agree. We cannot express any expectation regarding our PFIC status for 2026 or future taxable years.
If there are patents listed in the Orange Book for our active immunotherapies (ACI-35.030, ACI-24.060 and ACI-7104.056) and diagnostics (Tau-PET tracer PI-2620, a-syn-PET tracers ACI-12589 and ACI-15916 and TDP-43-PET tracer ACI-19626), respectively, those ANDAs and 505(b)(2) NDAs would be required to include a certification for each listed patent, indicating whether the ANDA applicant does or does not intend to challenge the patent.
If there are patents listed in the Orange Book for our active immunotherapies (ACI-35.030, ACI-24.060 and ACI-7104.056), our small molecule drugs (ACI-19764 NLRP3 inhibitor, Morphomer-Tau, and Morphomer-a-syn), and diagnostics (Tau-PET tracer PI-2620, a-syn-PET tracers ACI-12589 and ACI-15916 and TDP-43-PET tracer ACI- 8 Table of Contents 19626), respectively, those ANDAs and 505(b)(2) NDAs would be required to include a certification for each listed patent, indicating whether the ANDA applicant does or does not intend to challenge the patent.
While the European Commission issued an adequacy decision intended to remain in effect until June 2025 in respect of the UK’s data protection framework, enabling data transfers from EU Member States to the UK to continue without requiring organizations to put in place contractual or other measures in order to lawfully transfer personal data between the territories, the relationship between the UK and the EU in relation to certain aspects of data privacy and security law remains unclear.
While the European Commission issued an adequacy decision which was extended until December 2031 in respect of the UK’s data protection framework, enabling data transfers from EU Member States to the UK to continue without requiring organizations to put in place contractual or other measures in order to lawfully transfer personal data between the territories, the relationship between the UK and the EU in relation to certain aspects of data privacy and security law remains unclear.
Our clinical product candidates currently in development include our active immunotherapies (ACI-35.030, ACI-24.060 and ACI-7104.056) and diagnostics (Tau-PET tracer PI-2620, a-syn-PET tracers ACI-12589 and ACI-15916 and TDP-43-PET tracer ACI-19626).
Our clinical product candidates currently in development include our active immunotherapies (ACI-35.030, ACI-24.060 and ACI-7104.056) , small molecule drug program ACI-19764 (NLRP3 inhibitor), and diagnostics (Tau-PET tracer PI-2620, a-syn-PET tracers ACI-12589 and ACI-15916 and TDP-43-PET tracer ACI-19626).

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Item 4. Mine Safety Disclosures

Mine Safety Disclosures — required of mining issuers

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Biggest changeCrenezumab Our patent portfolio relating to crenezumab includes patents and patent applications with claims directed to composition of matter (including claims directed to the crenezumab antibody or a fragment thereof, a polynucleotide encoding the crenezumab antibody or a fragment thereof, a cell line used to produce the crenezumab antibody as well as pharmaceutical compositions comprising the crenezumab antibody), claims directed to treating certain indications using the crenezumab antibody including AD, claims directed to a method of manufacturing the crenezumab antibody and claims directed to diagnostic and prognostic uses of the crenezumab antibody.
Biggest changeCrenezumab Our global patent portfolio relating to crenezumab includes patents and patent applications with claims directed to compositions of matter, methods of treatment for certain indications including AD, and methods of use, among others.
Julien Rongère, Ph.D., our SVP Regulatory Affairs and Quality Assurance, gained specific expertise in the development of regulatory strategies for taking products from Phase 1 through to commercialization in the field of hematology/oncology and immunology/inflammation, including fast-to-market approaches, orphan drugs and pediatric development.
Julien Rongère, Ph.D., our SVP of Regulatory Affairs and Quality Assurance, gained specific expertise in the development of regulatory strategies for taking products from Phase 1 through to commercialization in the field of hematology/oncology and immunology/inflammation, including fast-to-market approaches, orphan drugs and pediatric development.
Our collaboration agreements are summarized in the table below: Figure 9: External validation and cash generation through external collaborations 1 ​ (1) Disclosure limited due to confidentiality agreements with collaboration partners; (2) In millions; (3) Total payments received from partner until termination of agreement; (4) Positron emission tomography; (5) In Alzheimer’s disease; (6) Phase 1 completed; (7) Equity investment; (8) Converted to CHF on date of receipt; (9) Excludes convertible note agreement of USD 50 million ; * previously licensed to Genentech (a member of the Roche Group) For any additional product candidates targeting large markets, we may, if appropriate, selectively partner with leading companies that we believe can contribute development, manufacturing and marketing expertise, geographic reach and/or other resources that can enhance the value of our wholly-owned products.
Our collaboration agreements are summarized in the table below: Figure 8: External validation and cash generation through external collaborations 1 (1) Disclosure limited due to confidentiality agreements with collaboration partners; (2) In millions; (3) Total payments received from partner until termination of agreement; (4) Positron emission tomography; (5) In Alzheimer’s disease; (6) Phase 1 completed; (7) Equity investment; (8) Converted to CHF on date of receipt; (9) Excludes convertible note agreement of USD 50 million ; * previously licensed to Genentech (a member of the Roche Group) For any additional product candidates targeting large markets, we may, if appropriate, selectively partner with leading companies that we believe can contribute development, manufacturing and marketing expertise, geographic reach and/or other resources that can enhance the value of our wholly-owned products.
ACI-12589 and ACI-15916. ACI-12589 and ACI-15916, if approved, would potentially compete with other a-syn-targeting PET tracers. This includes the 18F-UCB-2897 tracer developed by UCB, which is being evaluated in a Phase 1 study. ACI-19764.
ACI-12589 and ACI-15916, if approved, would potentially compete with other a-syn-targeting PET tracers. This includes the 18F-UCB-2897 tracer developed by UCB, which is being evaluated in a Phase 1 study. ACI-19764.
Our common shares were admitted to trading on Nasdaq Global Market on September 23, 2016, and trade under the symbol ACIU. Our general telephone number is (41) 21 345 91 21 and our internet address is www.acimmune.com.
Our common shares were admitted to trading on Nasdaq Global Market on September 23, 2016, and trade under the symbol ACIU. Our general telephone number is (41) 21 345 91 21 and our internet address is www.acimmune.com.
References to our website address do not constitute incorporation by reference of the information contained on the website, and the information contained on the website is not part of this document or any other document that we file with or furnish to the SEC.
References to our website address do not constitute incorporation by reference of the information contained on the website, and the information contained on the website is not part of this document or any other document that we file with or furnish to the SEC.
The SEC maintains an internet site that contains reports, proxy and information statements and other information regarding issuers that file electronically with the SEC, which can be found at http://www.sec.gov. Our agent for service of process in the United States is Cogency Global Inc. located at 122 East 42nd Street, 18th Floor, New York, New York 10168.
The SEC maintains an internet site that contains reports, proxy and information statements and other information regarding issuers that file electronically with the SEC, which can be found at http://www.sec.gov. Our agent for service of process in the United States is Cogency Global Inc. located at 122 East 42nd Street, 18th Floor, New York, New York 10168.
Post hoc analyses of this study series delivered highly encouraging data with respect to identification of a potential biomarker for PD, including: ● I n vivo target engagement of induced antibodies was demonstrated by lowering of oligomeric a-syn in CSF of immunized subjects (Figure 14, middle). ● The reduction of oligomeric a-syn in CSF correlated significantly with clinical improvement, the changes in MDS-UPDRS III score over time (Figure 14, right) . ​ 75 Table of Contents Figure 14: Pharmacokinetic and pharmacodynamic effect of ACI-7104.056 predecessor immunization in early PD patients ​ (1) Data from 75 ug dose group; (4) Cerebrospinal fluid; (5) Change in oligomeric a-syn calculated at week 26, change in UPDRS III calculated at week 100; (6) Unified Parkinson’s Disease Rating Scale Ref: Volc et al ., Lancet Neurology, 2020 These combined data support the role of a-syn in disease progression and demonstrate that a-syn directed immunization has the potential to positively impact clinical outcome.
Post hoc analyses of this study series delivered highly encouraging data with respect to identification of a potential biomarker for PD, including: ● I n vivo target engagement of induced antibodies was demonstrated by lowering of oligomeric a-syn in CSF of immunized subjects (Figure 14, middle). ● The reduction of oligomeric a-syn in CSF correlated significantly with clinical improvement, the changes in MDS-UPDRS III score over time (Figure 14, right) . ​ 76 Table of Contents Figure 14: Pharmacokinetic and pharmacodynamic effect of ACI-7104.056 predecessor immunization in early PD patients (1) Data from 75 ug dose group; (4) Cerebrospinal fluid; (5) Change in oligomeric a-syn calculated at week 26, change in UPDRS III calculated at week 100; (6) Unified Parkinson’s Disease Rating Scale Ref: Volc et al ., Lancet Neurology, 2020 These combined data support the role of a-syn in disease progression and demonstrate that a-syn directed immunization has the potential to positively impact clinical outcome.
Of note, antibodies raised in NHPs have >1000-fold preference for oligomers over monomers, similar to lecanemab (antibody titers against oligomeric Abeta shown in Figure 13; top) ; ● Target engagement was confirmed in situ, using brain sections from AD patients in which sera from the NHPs immunized with ACI-24.060 bound to the Abeta plaques while showing no reactivity to other tissues ; Figure 12: Abeta1-42 and pyroGlu Abeta IgG titers in NHP immunized with ACI-24.060 Ref : Fiorini et al. , CTAD 2023 71 Table of Contents Figure 13: Oligomeric Abeta IgG titers in NHP immunized with ACI-24.060 and preferential binding over Abeta monomers Ref : Fiorini et al. , CTAD 2023 Development of anti-Abeta active immunotherapy for AD in DS The AD pathology that commonly develops in people with DS bears remarkable similarities to familial and sporadic forms of AD and is characterized by a progressive accumulation in the brain of Abeta into amyloid plaques leading to the appearance of AD-related cognitive decline and a modification of other relevant biomarkers.
Of note, antibodies raised in NHPs have >1000-fold preference for oligomers over monomers, similar to lecanemab (antibody titers against oligomeric Abeta shown in Figure 13; top) ; 71 Table of Contents ● Target engagement was confirmed in situ, using brain sections from AD patients in which sera from the NHPs immunized with ACI-24.060 bound to the Abeta plaques while showing no reactivity to other tissues ; Figure 12: Abeta1-42 and pyroGlu Abeta IgG titers in NHP immunized with ACI-24.060 Ref : Fiorini et al. , CTAD 2023 72 Table of Contents Figure 13: Oligomeric Abeta IgG titers in NHP immunized with ACI-24.060 and preferential binding over Abeta monomers Ref : Fiorini et al. , CTAD 2023 Development of anti-Abeta active immunotherapy for AD in DS The AD pathology that commonly develops in people with DS bears remarkable similarities to familial and sporadic forms of AD and is characterized by a progressive accumulation in the brain of Abeta into amyloid plaques leading to the appearance of AD-related cognitive decline and a modification of other relevant biomarkers.
The trial will randomize approximately 500 participants with confirmed early-stage Tau pathology who will be treated over a four-year period. The trial will include analysis of Tau-PET as a potential surrogate biomarker, which might be used to initiate Phase 3 development to allow for overall program acceleration.
The trial aims to randomize approximately 500 participants with confirmed early-stage Tau pathology who will be treated over a four-year period. The trial will include analysis of Tau-PET as a potential surrogate biomarker, which might be used to initiate Phase 3 development to allow for overall program acceleration.
We have signed a number of licensing agreements with leading pharmaceutical companies to assist and accelerate the development of our product pipeline, including: ● a worldwide licensing agreement with Genentech signed in November 2006 (and amended in March 2009, January 2013, May 2014 and May 2015) for anti-Abeta antibodies for AD.
We have signed a number of licensing and other agreements with leading pharmaceutical companies to assist and accelerate the development of our product pipeline, including: ● a worldwide licensing agreement with Genentech signed in November 2006 (and amended in March 2009, January 2013, May 2014 and May 2015) for anti-Abeta antibodies for AD.
The steps required before a drug may be approved for marketing in the U.S. generally include: ● the completion of preclinical laboratory tests and animal tests conducted under cGLP regulations; 105 Table of Contents ● the submission to the FDA of an IND application for human clinical testing, which must become effective before human clinical studies commence; ● obtaining a positive opinion from the ethics committee (Europe)/institutional review board (U.S.) to commence study on human subjects; ● the performance of adequate and well-controlled human clinical studies to establish the safety and efficacy of the product candidate for each proposed indication and conducted in accordance with cGCP requirements; ● pre-NDA submission meeting with FDA (highly recommended); ● the submission to the FDA of an NDA; ● the FDA’s acceptance of the NDA; ● satisfactory completion of an FDA Pre-Approval Inspection (PAI) of the manufacturing facilities at which the product is made to assess compliance with cGMP requirements; ● the FDA’s review and approval of an NDA prior to any commercial marketing or sale of the drug in the U.S. ● In the EU, a similar process exists as in the US, with the additional involvement of payors early on in the development process.
The steps required before a drug may be approved for marketing in the U.S. generally include: ● the completion of preclinical laboratory tests and animal tests conducted under cGLP regulations; ● the submission to the FDA of an IND application for human clinical testing, which must become effective before human clinical studies commence; ● obtaining a positive opinion from the ethics committee (Europe)/institutional review board (U.S.) to commence study on human subjects; ● the performance of adequate and well-controlled human clinical studies to establish the safety and efficacy of the product candidate for each proposed indication and conducted in accordance with cGCP requirements; ● pre-NDA submission meeting with FDA (highly recommended); ● the submission to the FDA of an NDA; ● the FDA’s acceptance of the NDA; ● satisfactory completion of an FDA Pre-Approval Inspection (PAI) of the manufacturing facilities at which the product is made to assess compliance with cGMP requirements; ● the FDA’s review and approval of an NDA prior to any commercial marketing or sale of the drug in the U.S. ● In the EU, a similar process exists as in the US, with the additional involvement of payors early on in the development process.
This is predicted to increase to 139 million by 2050 (Alzheimer’s Disease International). ● The estimated total healthcare costs for the treatment of Alzheimer’s disease in the United States in 2022 is USD 321 billion per the Alzheimer’s Association.
This is predicted to increase to 139 million by 2050 (Alzheimer’s Disease International). ● The estimated total healthcare costs for the treatment of Alzheimer’s disease in the United States in 2022 was USD 321 billion per the Alzheimer’s Association.
The table below details the sizes and uses of our leased facilities as of December 31, 2024: ​ ​ ​ ​ ​ Location ​ Primary Function ​ Approximate Size École Polytechnique Fédérale Lausanne (EPFL) Innovation Park Building B, 1015 Lausanne, Vaud, Switzerland ​ Headquarters ​ Research, discovery, preclinical and clinical development ​ Chemistry manufacturing and control ​ 36,700 square feet ​ The Innovation Park of the EPFL serves as our corporate headquarters, our research facility and laboratories.
The table below details the sizes and uses of our leased facilities as of December 31, 2025: ​ ​ ​ ​ ​ Location ​ Primary Function ​ Approximate Size École Polytechnique Fédérale Lausanne (EPFL) Innovation Park Building B, 1015 Lausanne, Vaud, Switzerland ​ Headquarters ​ Research, discovery, preclinical and clinical development ​ Chemistry manufacturing and control ​ 36,700 square feet ​ The Innovation Park of the EPFL serves as our corporate headquarters, our research facility and laboratories.
Donanemab was approved in the U.S., Japan, China and Great Britain for the treatment of MCI and mild dementia due to Alzheimer's disease. While donanemab is administered only every 4 weeks, it also presents similar non-negligible safety risks, which, depending on ARIA severity, might require interruption or permanent discontinuation of treatment.
Donanemab was approved in the U.S., Europe, Japan, China, Australia and Great Britain for the treatment of MCI and mild dementia due to Alzheimer's disease. While donanemab is administered only every 4 weeks, it also presents similar non-negligible safety risks, which, depending on ARIA severity, might require interruption or permanent discontinuation of treatment.
The patent portfolios for our most advanced product candidates as of December 31, 2024 are summarized below: Anti-Tau active immunotherapies Our patent portfolio for anti-Tau active immunotherapies includes a patent family with composition-of-matter claims (including claims directed to the ACI-35 antigenic peptide and a pharmaceutical composition comprising such an antigenic peptide), claims directed to treating certain indications using ACI-35 including AD, and claims directed to using ACI-35 to induce an immune response.
The patent portfolios for our most advanced product candidates as of December 31, 2025 are summarized below: Anti-Tau active immunotherapies Our patent portfolio for anti-Tau active immunotherapies includes a patent family with composition-of-matter claims (including claims directed to the ACI-35 antigenic peptide and a pharmaceutical composition comprising such an antigenic peptide), claims directed to treating certain indications using ACI-35 including AD, and claims directed to using ACI-35 to induce an immune response.
Accelerating the advancement of our diagnostic portfolio Early detection of neurodegenerative diseases may be critical to enhancing the effectiveness of both symptomatic and disease-modifying therapies. As a result, therapeutic development for AD increasingly focuses on treating early-stage disease to delay or prevent progression and to preserve the maximum amount of cognitive function before it is irreversibly lost.
Our diagnostic portfolio The early detection of neurodegenerative diseases may be critical to enhancing the effectiveness of both symptomatic and disease-modifying therapies. As a result, therapeutic development for AD increasingly focuses on treating early-stage disease to delay or prevent progression and to preserve the maximum amount of cognitive function before it is irreversibly lost.
The industry is still in its infancy in terms of defining the pathology of neurodegenerative diseases. As disease understanding progresses, the number of novel product candidates may well increase and broaden the therapeutic and diagnostic options in our product markets. Currently, there are two FDA-approved disease-modifying products for AD, Leqembi (Biogen / Eisai) and Kisunla (Eli Lilly).
The industry is still in its infancy in terms of defining the pathology of neurodegenerative diseases. As disease understanding progresses, the number of novel product candidates may well increase and broaden the therapeutic and diagnostic options in our product markets. Currently, there are two commercially available FDA-approved disease-modifying products for AD, Leqembi (Biogen / Eisai) and Kisunla (Eli Lilly).
ACI-35.030 ACI-35.030 is a liposomal anti-pTau active immunotherapy formulation designed to elicit antibodies against extracellular pTau protein in order to prevent and reduce the spread and development of Tau pathology within the brain. In non-clinical studies, ACI-35.030 demonstrated an excellent non-clinical safety profile and highly specific antibody response against pTau.
Mechanism of action ACI-35.030 is a liposomal anti-pTau active immunotherapy formulation designed to elicit antibodies against extracellular pTau protein in order to prevent and reduce the spread and development of Tau pathology within the brain. In non-clinical studies, ACI-35.030 demonstrated an excellent non-clinical safety profile and highly specific antibody response against pTau.
As of December 31, 2024, we owned or co-owned 13 patents and approximately 5 patent applications in 16 countries in our main patent family directed to the PI-2620 molecule, its precursor and methods of using the PI-2620 to diagnose certain indications, including AD and PSP. This main patent family includes one issued U.S. patent.
As of December 31, 2025, we owned or co-owned 13 patents and approximately 5 patent applications in 16 countries in our main patent family directed to the PI-2620 molecule, its precursor and methods of using the PI-2620 to diagnose certain indications, including AD and PSP. This main patent family includes one issued U.S. patent.
Alzheimer’s and Dement. 2023 19:658-670. https://doi.org/10.1002/alz.12694; (3) Monoclonal antibody; (4) Neurodegenerative disease; (5) alpha-synuclein; (6) TAR DNA-binding protein 43; (7) Amyotrophic lateral sclerosis; (8) Limbic-predominant age-related TDP-43 encephalopathy Diagnosis typically takes the form of observation of cognitive, functional and behavioral impairment and other symptoms of the diseases, which are generally only apparent after irreversible neuronal damage has already occurred.
Alzheimer’s and Dement. 2023 19:658-670. https://doi.org/10.1002/alz.12694; (4) Monoclonal antibody; (5) alpha-synuclein; (6) TAR DNA-binding protein 43; (7) Amyotrophic lateral sclerosis; (8) Limbic-predominant age-related TDP-43 encephalopathy Diagnosis typically takes the form of observation of cognitive, functional and behavioral impairment and other symptoms of the diseases, which are generally only apparent after irreversible neuronal damage has already occurred.
We are advancing the clinical development of ACI-12589, the first molecule capable to detect pathological a-syn in the brain of patients with MSA and to differentiate them from controls (Figure 19), other synucleinopathies and more generally other neurodegenerative diseases. The preclinical and clinical data were published in October 2023 in Nature Communications.
We are advancing the clinical development of ACI-12589, the first molecule capable to detect pathological a-syn in the brain of patients with MSA and to differentiate them from controls (Figure 24), other synucleinopathies and more generally other neurodegenerative diseases. Preclinical and clinical data were published in October 2023 in Nature Communications.
ACI-7104.056, our active immunotherapy targeting pathological a-syn, is currently being tested in a placebo-controlled, double-blind, adaptive, biomarker-based Phase 2 study (VacSYn; NCT06015841) in the EU and in the UK. This trial is evaluating the safety and immunogenicity of ACI-7104.056 against a-syn and pathological a-syn species in early PD.
ACI-7104.056, our wholly owned active immunotherapy targeting pathological a-syn, is currently being tested in a placebo-controlled, double-blind, adaptive, biomarker-based Phase 2 study (VacSYn; NCT06015841) in the EU and in the UK. This trial is evaluating the safety and immunogenicity of ACI-7104.056 against a-syn and pathological a-syn species in early PD.
Most clinical studies now target mild or even preclinical stages of the disease increasing the need for accurate diagnosis that is independent of potentially subjective cognitive metrics. At least one study estimates that as many as one third of patients in previous AD studies did not in fact have AD.
Most clinical studies now target mild or even preclinical stages of the disease increasing the need for accurate diagnosis that is independent of potentially subjective cognitive metrics. At least one study estimated that as many as one third of patients in previous AD studies did not in fact have AD.
Product candidates that are studied for their safety and effectiveness in treating serious or life-threatening illnesses and that provide meaningful therapeutic benefit over existing treatments may 106 Table of Contents receive Accelerated Approval, which means that they may be approved on the basis of adequate and well-controlled clinical studies establishing that the product has an effect on a surrogate endpoint that is reasonably likely to predict a clinical benefit, or on the basis of an effect on a clinical endpoint other than survival or irreversible morbidity.
Product candidates that are studied for their safety and effectiveness in treating serious or life-threatening illnesses and that provide meaningful therapeutic benefit over existing treatments may receive Accelerated Approval, which means that they may be approved on the basis of adequate and well-controlled clinical studies establishing that the product has an effect on a surrogate endpoint that is reasonably likely to predict a clinical benefit, or on the basis of an effect on a clinical endpoint other than survival or irreversible morbidity.
Continuing to optimize our long-term growth by selectively partnering product candidates for global development and commercialization We have a strong track record of establishing value-driving collaboration agreements with leading pharmaceutical companies, such as Janssen, Takeda, Lilly and LMI.
Continuing to optimize our long-term growth by selectively partnering product candidates for global development and commercialization We have a strong track record of establishing value-driving collaboration agreements with leading pharmaceutical companies, such as Janssen, Takeda, Lilly and Lantheus.
Under this agreement, we may be eligible to receive an option exercise fee in the low-to-mid nine-figure USD range and additional potential development, commercial and sales-based milestones of up to approximately USD 2.1 (CHF 1.9) billion, excluding royalties.
Under this agreement, we may be eligible to receive an option exercise fee in the low-to-mid nine-figure USD range and additional potential development, commercial and sales-based milestones of up to approximately USD 2.1 (CHF 1.7) billion, excluding royalties.
The personnel tasked with QA have issued a set of approximately 136 standard operating procedures and working instructions and continuously train the relevant staff. Our QA personnel conduct regular audits, including in-person audits of the contract manufacturers, contract research organizations and laboratories conducting primary endpoint analysis.
The personnel tasked with QA have issued a set of approximately 163 standard operating procedures and working instructions and continuously train the relevant staff. Our QA personnel conduct regular audits, including in-person audits of the contract manufacturers, contract research organizations and laboratories conducting primary endpoint analysis.
Developed using our SupraAntigen technology, ACI-35.030/JNJ-2056 is designed to stimulate a patient’s immune system to produce antibodies against pathological phosphorylated Tau, which aggregates to create the neurofibrillary tangles that characterize AD. 76 Table of Contents Potential advantages of anti-pTau active immunotherapy over other therapeutic approaches ACI-35.030 induces a specific, early, long-lasting and boostable polyclonal antibody response against pathological Tau species.
Developed using our SupraAntigen technology, ACI-35.030/JNJ-2056 is designed to stimulate a patient’s immune system to produce antibodies against pathological phosphorylated Tau, which aggregates to create the neurofibrillary tangles that characterize AD. Potential advantages of anti-pTau active immunotherapy over other therapeutic approaches ACI-35.030 induces a specific, early, long-lasting and boostable polyclonal antibody response against pathological Tau species.
With greater financial resources at our disposal and the significant knowledge acquired by our scientists and scientific leadership, we intend to retain selected promising product candidates in-house for a longer period of time and fund their development from our own resources.
With the required financial resources at our disposal and the significant knowledge acquired by our scientists and scientific leadership, we intend to retain selected promising product candidates in-house for a longer period of time and fund their development from our own resources.
If the appropriate maintenance, renewal, annuity, or other governmental fees are paid, national-stage applications claiming priority from this PCT patent application, if issued, are expected to expire in 2039, excluding any additional term for patent term adjustments or patent term extensions, as applicable.
If the appropriate maintenance, renewal, annuity, or other governmental fees are paid, national-stage applications claiming priority from this PCT patent application, if issued, are expected to expire in 2037, excluding any additional term for patent term adjustments or patent term extensions, as applicable.
Since 2008, our regulatory department has filed a total of 24 clinical trial applications in the EU (one each in Austria, Denmark and Poland, two in Spain and the Netherlands, three in Germany, four in Finland and Sweden and eight in the UK) and 5 INDs in the U.S.
Since 2008, our regulatory department has filed a total of 27 clinical trial applications in the EU (one each in Austria, Denmark and Poland, and two in Spain, three in Germany and the Netherlands, four in Finland and Sweden and eight in the UK) and 5 INDs in the U.S.
The Centralized Procedure is compulsory for human medicines for the treatment of human immunodeficiency virus or acquired immune deficiency syndrome (AIDS), cancer, diabetes, neurodegenerative diseases, autoimmune and other immune dysfunctions, and viral diseases; for veterinary medicines for use as growth or yield enhancers; for medicines derived from biotechnology processes, such as genetic engineering; for advanced-therapy medicines, such as gene-therapy, somatic cell-therapy or tissue-engineered medicines; and for officially designated ‘orphan medicines’ (medicines used for rare human diseases).
The Centralized Procedure is compulsory for human medicines for the treatment of human immunodeficiency virus or acquired immune deficiency syndrome (AIDS), cancer, diabetes, neurodegenerative diseases, autoimmune and other immune dysfunctions, and viral diseases; for veterinary medicines for use as growth or yield enhancers; for medicines 102 Table of Contents derived from biotechnology processes, such as genetic engineering; for advanced-therapy medicines, such as gene-therapy, somatic cell-therapy or tissue-engineered medicines; and for officially designated ‘orphan medicines’ (medicines used for rare human diseases).
These guidelines provide additional guidance on the factors that the EMA will consider in relation to the development and evaluation of drug products and may include, among other things, 113 Table of Contents the preclinical studies required in specific cases, the manufacturing and control information that should be submitted in a marketing authorization application, and the post-approval measures required to monitor patients and evaluate the long-term efficacy and potential adverse reactions.
These guidelines provide additional guidance on the factors that the EMA will consider in relation to the development and evaluation of drug products and may include, among other things, the preclinical studies required in specific cases, the manufacturing and control information that should be submitted in a marketing authorization application, and the post-approval measures required to monitor patients and evaluate the long-term efficacy and potential adverse reactions.
The prevalence of AD in people with DS is more than 50% over the 72 Table of Contents age of 50 and 75–100% over the age of 60 years (Strydom, 2018). It is estimated that there are six million people with DS worldwide, with 250,000 in the U.S..
The prevalence of AD in people with DS is more than 50% over the 73 Table of Contents age of 50 and 75–100% over the age of 60 years (Strydom, 2018). It is estimated that there are six million people with DS worldwide, with 250,000 in the U.S.
Orphan-drug designation Under the Orphan Drug Act, the FDA may grant orphan designation to a drug or biological product intended to treat a rare disease or condition, which is a disease or condition that either affects fewer than 200,000 individuals in the U.S., or affects more than 200,000 individuals in the U.S. but there is no reasonable expectation that the cost of developing and making a drug product available in the U.S. for this type of disease or condition will be recovered from sales of the 109 Table of Contents product in the U.S.
Orphan-drug designation Under the Orphan Drug Act, the FDA may grant orphan designation to a drug or biological product intended to treat a rare disease or condition, which is a disease or condition that either affects fewer than 200,000 individuals in the U.S., or affects more than 200,000 individuals in the U.S. but there is no reasonable expectation that the cost of developing and making a drug product available in the U.S. for this type of disease or condition will be recovered from sales of the product in the U.S.
This patent family currently contains approximately 30 issued patents in 27 countries. The issued patents in this patent family, if the appropriate maintenance, renewal, annuity or other governmental fees are paid, are expected to expire in 2030, excluding any additional term for patent term adjustments or patent term extensions.
This patent family currently contains approximately 29 issued patents in 27 countries. The issued patents in this patent family, if the appropriate maintenance, renewal, annuity or other governmental fees are paid, are expected to expire in 2030, excluding any additional term for patent term adjustments or patent term extensions.
This peptide coupled to a carrier protein facilitates the induction of an a-syn-specific antibody response that binds to toxic aggregated a-syn species with high selectivity ( Mandler M et al ., Acta Neuropathol, 2014 ). ● Immunization of wild-type and transgenic mice, resulted in high antibody titres in plasma, which crossed into the cerebrospinal fluid (CSF) and recognized a-syn aggregates.
This peptide coupled to a carrier protein facilitates the induction of an a-syn-specific antibody response that binds to toxic aggregated a-syn species with high selectivity ( Mandler M et al ., Acta Neuropathol, 2014 ). 75 Table of Contents ● Immunization of wild-type and transgenic mice, resulted in high antibody titres in plasma, which crossed into the cerebrospinal fluid (CSF) and recognized a-syn aggregates.
The FDASIA requires that a sponsor who is planning to submit a marketing application for a drug or biological product that includes a new active ingredient, new indication, new dosage form, new dosing regimen or new route of administration submit an initial Pediatric Study Plan within 60 days of an end-of-Phase-2 meeting or as may be agreed between the sponsor and the FDA.
The FDASIA requires that a sponsor who is planning to submit a marketing application for a drug 98 Table of Contents or biological product that includes a new active ingredient, new indication, new dosage form, new dosing regimen or new route of administration submit an initial Pediatric Study Plan within 60 days of an end-of-Phase-2 meeting or as may be agreed between the sponsor and the FDA.
This period may, however, be reduced to 6 years if, at the end of the fifth year, it is established, with respect to the drug concerned, that the criteria for orphan-drug designation are no longer met; in other words, when it is shown on the basis of available evidence that the product is sufficiently profitable not to justify maintenance of market exclusivity.
This period may, however, be reduced to 6 years if, at the end of the fifth year, it is established, with respect to the drug concerned, that the criteria for orphan-drug designation are no longer met; in other words, when it is shown on the basis of available evidence that the product is sufficiently profitable not to justify 105 Table of Contents maintenance of market exclusivity.
Figure 2: Neurodegenerative diseases represent a large and growing market (1) Alzheimer’s disease; (2) Gustavsson et al.
Figure 2: Neurodegenerative diseases represent a large and growing market (1) Neurodegenerative diseases; (2) Alzheimer’s disease; (3) Gustavsson et al.
We instead contract with and rely on third-party CMOs to manufacture, package, label, store, test and distribute all preclinical and clinical supplies of our product candidates, and we plan to continue to do so for the foreseeable future.
We instead contract with and rely on third-party CMOs to manufacture, package, label, store, test and distribute all non-clinical and clinical supplies of our product candidates, and we plan to continue to do so for the foreseeable future.
We converted to a Swiss stock corporation ( société anonyme ) under the laws of Switzerland on August 25, 2003. Our Swiss enterprise identification number is CHE-109.878.825. Our domicile and registered office is in Ecublens, at the École Polytechnique Fédérale Lausanne (EPFL) Innovation Park Building B, 1015 121 Table of Contents Lausanne, Vaud, Switzerland.
We converted to a Swiss stock corporation ( société anonyme ) under the laws of Switzerland on August 25, 2003. Our Swiss enterprise identification number is CHE-109.878.825. Our domicile and registered office is in Ecublens, at the École Polytechnique Fédérale Lausanne (EPFL) Innovation Park Building B, 1015 Lausanne, Vaud, Switzerland.
In the United States, through Q1 2025, there were only two approved disease-modifying therapies for AD. These provided incomplete clinical efficacy, presented non-negligible safety risks or failed to halt disease progression.
In the United States, through Q1 2026, there were only two approved disease-modifying therapies for AD. These provided incomplete clinical efficacy, presented non-negligible safety risks or failed to halt disease progression.
Later discovery of previously 110 Table of Contents unknown problems with a product, including AEs of unanticipated severity or frequency, or with manufacturing processes, or failure to comply with regulatory requirements, may result in revisions to the approved labeling to add new safety information, imposition of post-marketing studies or clinical studies to assess new safety risks, or imposition of distribution or other restrictions under a REMS program.
Later discovery of previously unknown problems with a product, including AEs of unanticipated severity or frequency, or with manufacturing processes, or failure to comply with regulatory requirements, may result in revisions to the approved labeling to add new safety information, imposition of post-marketing studies or clinical studies to assess new safety risks, or imposition of distribution or other restrictions under a REMS program.
Our dual technology platforms allow for a multi-modal approach encompassing a portfolio of active immunotherapies, antibodies and small molecules tailored to the underlying pathology driving patients’ disease. In addition to generating targeted monotherapies, this approach creates the potential for combination regimens, which may treat a broader spectrum of disease and offer greater efficacy.
Our dual technology platforms allow for a multi-modal approach encompassing a portfolio of active immunotherapies, antibodies and small molecules tailored to the underlying pathology driving patients’ disease. In 60 Table of Contents addition to generating targeted monotherapies, this approach creates the potential for combination regimens, which may treat a broader spectrum of disease and offer greater efficacy.
Similar laws have been enacted or are under consideration in foreign jurisdictions, including France, which has adopted the Loi Bertrand, or French Sunshine Act, which became effective in 2013. In addition, the Code of Ethics from the EFPIA requires certain disclosures of interactions with institutions and healthcare professionals, depending on the jurisdictions in which we operate.
Similar laws have been enacted or are under consideration in foreign jurisdictions, including France, which has adopted the Loi Bertrand, or French Sunshine Act, which became effective in 2013. In addition, the Code of Ethics from the EFPIA requires 111 Table of Contents certain disclosures of interactions with institutions and healthcare professionals, depending on the jurisdictions in which we operate.
Despite these shortcomings, marketed therapies, such as Eisai and Pfizer’s Aricept which only address symptoms, have achieved peak annual global sales of approximately USD 2.4 billion prior to loss of exclusivity. Similarly, in the treatment of PD, the current standard of care is intended only to alleviate clinical symptoms.
Despite these 58 Table of Contents shortcomings, marketed therapies, such as Eisai and Pfizer’s Aricept which only address symptoms, have achieved peak annual global sales of approximately USD 2.4 billion prior to loss of exclusivity. Similarly, in the treatment of PD, the current standard of care is intended only to alleviate clinical symptoms.
The Company’s CTA received approval from the UK MHRA in Q2 2022 and from the AEMPS in Q3 2022 to initiate development of ACI-24.060 in patients with prodromal AD and in adult subjects with DS with presence of brain amyloid pathology . Study part 1 is being conducted in several centers located in the UK and Spain.
The Company’s CTA received approval from the UK MHRA in Q2 2022 and from the AEMPS in Q3 2022 to initiate development of ACI-24.060 in patients with prodromal AD and in adult subjects with DS with presence of brain amyloid pathology. 74 Table of Contents Study part 1 is being conducted in several centers located in the UK and Spain.
The termination became effective in April 2024; ● a worldwide licensing agreement with Janssen signed in December 2014 (and amended in April 2016, July 2017, January 2019, November 2019, December 2022, November 2023, September 2024 and December 2024) for therapeutic anti-Tau active immunotherapies for AD, and potentially other tauopathies, under which we may become eligible to receive payments totaling up to CHF 500 million, excluding royalties; ● a worldwide licensing and collaboration agreement (LCA) with LMI (formerly Piramal Imaging SA) signed in May 2014 (and amended in June 2022) for small-molecule Tau ligands for use as PET tracers under which we may become eligible to receive payments totaling up to EUR 160 (CHF 152) million, excluding royalties; ● a worldwide license agreement with Lilly to research and develop Morphomer Tau small molecules for the treatment of AD and other neurodegenerative diseases, which was entered into in December 2018 (and amended in September 2019 and March 2020).
The termination became effective in April 2024; ● a worldwide licensing agreement with Janssen signed in December 2014 (and amended in April 2016, July 2017, January 2019, November 2019, December 2022, November 2023, September 2024 and December 2024) for therapeutic anti-Tau active immunotherapies for AD, and potentially other tauopathies, under which we may become eligible to receive payments totaling up to CHF 500 million, excluding royalties; ● a worldwide licensing and collaboration agreement (LCA) with Lantheus (formerly LMI), signed in May 2014 (and amended in June 2022) for small-molecule Tau ligands for use as PET tracers under which we may become eligible to receive payments totaling up to EUR 160 (CHF 150) million, excluding royalties; ● a worldwide license agreement with Lilly to research and develop Morphomer Tau small molecules for the treatment of AD and other neurodegenerative diseases, which was entered into in December 2018 (and amended in September 2019 and March 2020).
A cascade of molecular events begins with the misfolding of single proteins within a cell, which then aggregate and ultimately form larger aggregates including plaques and tangles. These misfolded proteins are then exported or shed from dying neurons where they can spread to healthy cells nearby.
A cascade of molecular events begins with the misfolding of single proteins within a cell, which then aggregate and ultimately form larger aggregates including plaques and tangles. These misfolded proteins are then 59 Table of Contents exported or shed from dying neurons where they can spread to healthy cells nearby.
However, even if a product candidate qualifies for one or more of these programs, the FDA may later decide that the product candidate no longer meets the conditions for qualification. The Fast Track program is intended to expedite or facilitate the process for reviewing new drugs that meet certain criteria.
However, even if a product candidate qualifies for one or more of these programs, the FDA may later decide that the product candidate no longer meets the conditions for qualification. 96 Table of Contents The Fast Track program is intended to expedite or facilitate the process for reviewing new drugs that meet certain criteria.
The IND will automatically become effective 30 days after receipt by the FDA, unless the FDA raises concerns or questions about the conduct of the studies as outlined in the IND prior to that time. In this case, the IND sponsor and the FDA must resolve any outstanding concerns before clinical studies can proceed.
The IND will automatically become effective 30 days after receipt by the FDA, 97 Table of Contents unless the FDA raises concerns or questions about the conduct of the studies as outlined in the IND prior to that time. In this case, the IND sponsor and the FDA must resolve any outstanding concerns before clinical studies can proceed.
Data exclusivity prevents regulatory authorities in the EU from referencing the innovator’s data to assess a generic (abbreviated) application. During the additional 2-year period of market exclusivity, a generic marketing authorization can be submitted, and the innovator’s data may be referenced, but no generic medicinal product can be marketed until the expiration of the market exclusivity.
Data exclusivity prevents regulatory authorities in the EU from referencing the innovator’s data to assess a generic (abbreviated) application. During the 104 Table of Contents additional 2-year period of market exclusivity, a generic marketing authorization can be submitted, and the innovator’s data may be referenced, but no generic medicinal product can be marketed until the expiration of the market exclusivity.
Additionally, disease-specific imaging and fluid biomarkers and progression of motor and non-motor symptoms of PD will be monitored. The VacSYn trial commenced in July 2023 with the dosing of the first patient and is progressing well with over 30 patients randomized in Part 1 of the study.
Additionally, disease-specific imaging and fluid biomarkers and progression of motor and non-motor symptoms of PD will be monitored. The VacSYn 62 Table of Contents trial commenced in July 2023 with the dosing of the first patient and is progressing well with over 30 patients randomized in Part 1 of the study.
These third-party payors are increasingly focused on containing healthcare costs by challenging the price and examining the cost-effectiveness of medical products and services. In addition, significant uncertainty exists as to the coverage and reimbursement status of newly approved healthcare product candidates.
These third-party payors are increasingly focused on containing healthcare costs by challenging the price and examining the cost-effectiveness of medical products and services. 109 Table of Contents In addition, significant uncertainty exists as to the coverage and reimbursement status of newly approved healthcare product candidates.
ACI-35.030 – anti-pTau active immunotherapy ACI-35.030, AC Immune’s active immunotherapy developed in collaboration with Janssen, is selective for pathological phosphorylated Tau (pTau) and was advanced into the Re T ain Phase 2b study (NCT06544616) that was initiated with the first patient being dosed in H2 2024. ACI-35.030 (now called JNJ-2056) is being assessed in subjects with preclinical (i.e., pre-symptomatic) AD.
ACI-35.030 – anti-pTau active immunotherapy ACI-35.030, AC Immune’s active immunotherapy developed in collaboration with Janssen, is selective for pathological phosphorylated Tau (pTau) and was advanced into the ReTain Phase 2b study (NCT06544616) that was initiated with the first patient being dosed in H2 2024. ACI-35.030 (now called JNJ-2056) is being assessed in subjects with preclinical (i.e., pre-symptomatic) AD.
Re T ain is a multicenter, randomized, placebo-controlled, double-blind, parallel-group study to assess efficacy, safety and immunogenicity of ACI-35.030/JNJ-2056 in participants with preclinical AD. The purpose of this study is to assess the effect of this anti-pTau active immunotherapy on cognitive decline, as measured by Preclinical Alzheimer's disease Cognitive Composite 5 (PACC-5) compared with placebo.
ReTain is a multicenter, randomized, placebo-controlled, double-blind, parallel-group study to assess efficacy, safety and immunogenicity of ACI-35.030/JNJ-2056 in participants with preclinical AD. The purpose of this study is to assess the effect of this anti-pTau active immunotherapy on cognitive decline, as measured by Preclinical Alzheimer's disease Cognitive Composite 5 (PACC-5) compared with placebo.
Our patent portfolio for ACI-24 also includes a patent family relating to therapeutic anti-Abeta treatment claims (including claims directed to a pharmaceutical composition comprising an antigenic peptide), and claims directed to using such active immunotherapies in treating, preventing, inducing a protective immune response against or alleviating the symptoms associated with an Abeta-associated disease in a subject, among others.
Our patent portfolio for ACI-24 also includes a patent family relating to therapeutic anti-Abeta treatment claims (including claims directed to a pharmaceutical composition comprising an antigenic peptide), and claims directed to using such active immunotherapies in treating, preventing, inducing a protective immune response against or alleviating 92 Table of Contents the symptoms associated with an Abeta-associated disease in a subject, among others.
The patent term restoration period is generally one-half of the time between the effective date of an IND and the submission date of an NDA, plus the time between the submission date of an NDA and the approval of that application, except that the review period is reduced by any time during which the applicant failed to exercise due diligence.
The patent term restoration period is generally one-half of the time between the effective date of an IND and the submission date of an NDA, plus the time between the submission date of an NDA and the approval of that application, except that the review period is reduced by any time during which the applicant failed to 101 Table of Contents exercise due diligence.
ACI-19764 exhibits excellent efficacy in low nM range in translationally relevant in vitro assays such the NLRP3 activation in human whole blood assay and is at least a log more efficacious than the reference standard compound, MCC950 (Figure 27B).
ACI-19764 exhibits excellent efficacy in low nM range in translationally relevant in vitro assays such as the NLRP3 activation in human whole blood assay and is at least a log more efficacious than the reference standard compound, MCC950 (Figure 20B).
However, should the Company’s PI-2620 be approved, it would also compete with (i) 18F-florzolotau (previously known as APN-1607), a product candidate advanced by Aprinoia currently in Phase 2 (USA, Taiwan, Japan) and Phase 3 (China) trials; (ii) 18F-MK-6240, developed by Lantheus, currently in Phase 2 and 3 clinical trials; (iii) 18F-GTP1, which is being developed by Genentech and has completed a Phase 2 study in subjects at risk of developing ADAD, (iv) 18F-RO6958948, for which Roche has completed a Phase 1 study in patients with AD and (v) 18F-JNJ-067, for which Janssen has completed a Phase 1 study in patients with AD.
However, should the Company’s PI-2620 be approved, it would also compete with (i) 18F-florzolotau (previously known as APN-1607), a product candidate advanced by Aprinoia currently in Phase 2 (USA, Taiwan, Japan) and Phase 3 (China) trials; (ii) 18F-MK-6240, developed by Lantheus, currently in Phase 2 and 3 clinical trials; (iii) 18F-GTP1, which is being developed by Genentech and has completed a Phase 2 study in subjects at risk of developing ADAD, (iv) 18F-RO6958948, for which Roche has completed a Phase 1 study in patients with AD and (v) 18F-JNJ-067, for which Janssen has completed a Phase 1 study in patients with AD. 90 Table of Contents ACI-12589 and ACI-15916.
Any failure to achieve and maintain compliance with the laws, regulations and standards, suspension of the manufacturing of our product candidates or withdrawals of cGMP permissions, which would adversely affect our business and reputation, are defined in the master service agreements and quality agreements.
Any failure to achieve 94 Table of Contents and maintain compliance with the laws, regulations and standards, suspension of the manufacturing of our product candidates or withdrawals of cGMP permissions, which would adversely affect our business and reputation, are defined in the master service agreements and quality agreements.
Figure 3 shows how misfolded proteins play a key role in the pathology of neurodegenerative diseases. Figure 3: Misfolded proteins key impact on the pathology of neurodegenerative diseases Typically, protein misfolding occurs in response to cellular stress, which can be triggered by many different, largely unknown, causes.
Figure 3 shows how misfolded proteins play a key role in the pathology of neurodegenerative diseases. Figure 3: Misfolded proteins key impact on the pathology of neurodegenerative diseases Typically, protein misfolding occurs following cellular stress, which can be triggered by many different, largely unknown, causes.
The growth in the number of people with neurodegenerative diseases has been significant, as evidenced by the prevalence of people affected by AD and PD, two of the most common neurodegenerative diseases. 56 Table of Contents ● The World Health Organization recognizes dementia as a global public health priority .
The growth in the number of people with neurodegenerative diseases has been significant, as evidenced by the prevalence of people affected by AD and PD, two of the most common neurodegenerative diseases. ● The World Health Organization recognizes dementia as a global public health priority .
Further information concerning details of our agreements and collaborations can be found under “Item 5: Operating and financial review and prospects.” Competition The pharmaceutical and biopharmaceutical industries are highly competitive across all therapeutic fields.
Further information concerning details of our agreements and collaborations can be found under “Item 5: Operating and financial review and prospects.” 89 Table of Contents Competition The pharmaceutical and biopharmaceutical industries are highly competitive across all therapeutic fields.
As every quality issue ultimately requires regulatory involvement and input, this approach is intended to lead to rapid resolution of issues and ensure full compliance to satisfy both the reviewers and the inspectors at the government health authorities.
As every quality issue ultimately requires regulatory involvement and input, this approach is intended to lead to rapid resolution of issues and ensure full compliance to satisfy both the 95 Table of Contents reviewers and the inspectors at the government health authorities.
This robust approach to targeting neurodegenerative diseases is enabled by our two validated technology platforms, SupraAntigen 58 Table of Contents and Morphomer, which generate highly specific biologics and small molecule inhibitors that can distinguish normal from misfolded proteins and inhibit key disease pathways both inside and outside of cells.
This robust approach to targeting neurodegenerative diseases is enabled by our two validated technology platforms, SupraAntigen and Morphomer, which generate highly specific biologics and small molecule inhibitors, respectively, that can distinguish normal from misfolded proteins and inhibit key disease pathways both inside and outside of cells.
This approach will reduce the burden for infusion centers and enhance access to a broader patient population. 69 Table of Contents In addition to these advantages, active immunotherapies allow for more simplified distribution logistics and cost-effectiveness. These factors are crucial to enable their global application as preventative therapies.
This approach will reduce the burden for infusion centers and enhance access to a broader patient population. In addition to these advantages, active immunotherapies allow for more simplified distribution logistics and cost-effectiveness. These factors are crucial to enable their global application as preventative therapies.
Such scrutiny has resulted in several recent congressional inquiries and proposed and enacted federal and state legislation designed to, among other things, bring more transparency to product pricing, review the relationship between pricing and manufacturer patient programs, and reform government program reimbursement methodologies for products.
Such scrutiny has resulted in several recent congressional inquiries and proposed and enacted federal and state legislation designed to, among other things, bring more transparency to 110 Table of Contents product pricing, review the relationship between pricing and manufacturer patient programs, and reform government program reimbursement methodologies for products.
We will continue to seek to retain certain indications (e.g. NeuroOrphan) and/or geographies, such that we could begin to grow our own marketing capabilities and develop AC Immune into a fully integrated pharmaceutical company.
We will continue to seek to retain certain indications and/or geographies, such that we could begin to grow our own marketing capabilities and develop AC Immune into a fully integrated pharmaceutical company.
Under the terms of the agreement, AC Immune received an upfront payment of USD 100.0 (CHF 92.3) million from Takeda and is eligible to receive payments of up to approximately USD 2.1 (CHF 1.9) billion including an option exercise fee in the low-to-mid nine-figure USD 61 Table of Contents range and potential development, commercial and sales-based milestone payments.
Under the terms of the agreement, AC Immune received an upfront payment of USD 100.0 (CHF 92.3) million from Takeda and is eligible to receive payments of up to approximately USD 2.1 (CHF 1.7) billion including an option exercise fee in the low-to-mid nine-figure USD range and potential development, commercial and sales-based milestone payments.
Our patent portfolio relating to a-syn diagnostics includes patents and patent applications that we own in ten different patent families.
Our patent portfolio relating to a-syn diagnostics includes patents and patent applications that we own in nine different patent families.
Moreover, pediatric exclusivity, if granted, may add 6 months 111 Table of Contents of exclusivity if the reference product has been studied with respect to a pediatric indication in accordance with certain regulatory requirements.
Moreover, pediatric exclusivity, if granted, may add 6 months of exclusivity if the reference product has been studied with respect to a pediatric indication in accordance with certain regulatory requirements.
Inclusion of orphan drugs in reimbursement systems tend to focus on the medical usefulness, need, quality and economic benefits to patients and the healthcare system as for any drug. Acceptance of any medicinal product for reimbursement may come with cost, use and often volume restrictions, which again can vary by country. In addition, results based rules of reimbursement may apply.
Inclusion of orphan drugs in reimbursement systems tend to focus on the medical usefulness, need, quality and economic benefits to patients and the healthcare system as for any drug. Acceptance of any medicinal product for reimbursement may come with cost, use and often volume restrictions, which again can vary by country.
Ultimately, it is our belief that Precision Medicine will increase the chance of treatment success by enabling clinical trial participants to be better defined by their various proteinopathies, allowing for treatment with the right therapies at the right time.
Ultimately, it is our belief that this approach will increase the chance of treatment success by enabling clinical trial participants to be better defined by their various proteinopathies, allowing for treatment with the right therapies at the right time.
The ongoing trial will randomize approximately 500 79 Table of Contents participants with confirmed early-stage brain Tau pathology, who will be treated over a four-year period. The trial will also include interim biomarker analyses, notably on brain Tau-PET scan, potentially allowing for acceleration towards a regulatory filing. The first patient was dosed in H2 2024.
The ongoing trial aims to randomize approximately 500 participants with confirmed early-stage brain Tau pathology, who will be treated over a four-year period. The trial will also include interim biomarker analyses, notably on brain Tau-PET scan, potentially allowing for acceleration towards a regulatory filing. The first patient was dosed in H2 2024.
Figure 10: SupraAntigen and Morphomer platforms: an integrated approach to CNS-specific therapies (1) Nanomolar; (2) Picomolar; (3) Central nervous system; (4) Blood-brain barrier; (5) alpha-synuclein; (6) TAR DNA-binding protein 43 The SupraAntigen platform was first developed by AC Immune’s scientific co-founders to overcome a challenge common to neurodegenerative diseases: the lack of immunogenicity of disease-causing self-proteins.
Figure 9: SupraAntigen and Morphomer platforms: an integrated approach to CNS-specific therapies ​ (1) Nanomolar; (2) Picomolar; (3) Central nervous system; (4) Blood-brain barrier; (5) alpha-synuclein; (6) TAR DNA-binding protein 43 The SupraAntigen platform was first developed by AC Immune to overcome a challenge common to neurodegenerative diseases: the lack of immunogenicity of the disease-causing self-proteins.
Kinetics and duration of the IgG profiles demonstrated the ability of ACI-35.030 to drive a selective response against pathological Tau species while avoiding the generation of antibodies that bind to non-phosphorylated Tau. After the first injection of JACI-35.054, antibody IgG response rates against pTau, anti-ePHF, and anti-Tau were less elevated as compared to ACI-35.030.
Kinetics and duration of the IgG profiles demonstrated the ability of ACI-35.030 to drive a selective response against pathological Tau species while avoiding the generation of antibodies that bind to non-phosphorylated Tau (Sol et al. , 2025 eBiomedicine). After the first injection of JACI-35.054, antibody IgG response rates against pTau, ePHF, and Tau were less elevated as compared to ACI-35.030.
The initiation of randomization in the subsequent cohort(s) is based on interim safety and tolerability data review from the previous cohort(s) and Data and Safety Monitoring Board (DSMB) approval. Interim analyses on safety/tolerability and immunogenicity are being conducted in each cohort at different predefined study time points.
The initiation of randomization in the subsequent cohort(s)/subcohort(s) is based on interim safety and tolerability data review from the previous cohort(s)/subcohort(s) and Data and Safety Monitoring Board (DSMB) approval. Interim analyses on safety/tolerability and immunogenicity may be conducted in each cohort/subcohort at different predefined study time points.

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Item 5. Market for Registrant's Common Equity

Market for Common Equity — stock, dividends, buybacks

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Biggest changeThe following table presents the other operating income/(expense), net during the years ended December 31, 2024 and 2023: ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ For the Year Ended ​ ​ ​ ​ December 31, ​ ​ In CHF thousands ​ 2024 2023 Change Other operating income/(expense), net ​ 142 1,486 (1,344) Total other operating income/(expense), net ​ 142 1,486 (1,344) ​ The decrease of CHF 1.4 million in grant income primarily resulted from activities related to our MJFF awards that were completed prior to the start of the current period. ​ Finance result, net For the year ended December 31, 2024, net finance result was a CHF 1.5 million gain compared with a CHF 0.6 million loss for the comparable period in 2023.
Biggest changeThe following table presents the other operating income/(expense), net during the years ended December 31, 2025 and 2024: ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ For the Year Ended ​ ​ ​ ​ December 31, ​ ​ In CHF thousands ​ 2025 ​ ​ ​ 2024 ​ ​ ​ Change Other operating income/(expense), net ​ 94 142 (48) Total other operating income/(expense), net ​ 94 142 (48) ​ ​ 124 Table of Contents Restructuring expenses, net For the year ended December 31, 2025, the Company recorded CHF 0.5 million of restructuring expenses compared to nil in the corresponding prior year. ​ ​ ​ ​ ​ ​ ​ ​ ​ For the Year Ended ​ ​ ​ ​ December 31, ​ ​ ​ ​ 2025 ​ 2024 ​ Change Restructuring expenses ​ (455) ​ ​ ​ — ​ ​ ​ (455) Total Restructuring expenses ​ (455) — (455) ​ The increase of restructuring expenses pertained to a 2025 event, and consists of termination benefits of CHF 2.1 million.
This termination became effective in April 2024. The Company regained the global rights to semorinemab in February 2025. In May 2014 (as amended in June 2022), we entered into a license and collaboration agreement with LMI (formerly Piramal Imaging SA) covering our Tau-PET Imaging tracers.
This termination became effective in April 2024. The Company regained the global rights to semorinemab in February 2025. In May 2014 (as amended in June 2022), we entered into a license and collaboration agreement with Lantheus (formerly LMI and formerly Piramal Imaging SA) covering our Tau-PET Imaging tracers.
The structure of the collaboration agreement is as follows: ● A n exclusive license: granted by us to Lilly under certain of our intellectual property to develop, manufacture and commercialize products containing Morphomer Tau small molecules for the treatment of AD and other neurodegenerative diseases throughout the world in any indication. ● Clinical milestone payment s: payable upon completion of the Lilly preclinical activities period and following the first patient dosed in a Phase 2 and Phase 3 clinical study of a licensed product in the U.S. or the EU. 126 Table of Contents ● Regulatory milestone payments : payable within 60 days after obtaining regulatory approval for any licensed product in the first indication and any licensed product in certain additional indications in the U.S., Europe and Japan, respectively. ● Commercialization milestones : payable upon achieving certain commercial sales milestones. ● Royalties : payable on sales with royalty rates differing based on the level of annual sales of licensed products.
The structure of the collaboration agreement is as follows: ● A n exclusive license: granted by us to Lilly under certain of our intellectual property to develop, manufacture and commercialize products containing Morphomer Tau small molecules for the treatment of AD and other neurodegenerative diseases throughout the world in any indication. ● Clinical milestone payment s: payable upon completion of the Lilly preclinical activities period and following the first patient dosed in a Phase 2 and Phase 3 clinical study of a licensed product in the U.S. or the EU. ● Regulatory milestone payments : payable within 60 days after obtaining regulatory approval for any licensed product in the first indication and any licensed product in certain additional indications in the U.S., Europe and Japan, respectively. ● Commercialization milestones : payable upon achieving certain commercial sales milestones. ● Royalties : payable on sales with royalty rates differing based on the level of annual sales of licensed products.
Our future funding requirements will depend on many factors, including but not limited to the following: · The scope, rate of progress, results and cost of our preclinical and clinical studies and other related activities, according to our long-term strategic plan; · The cost of manufacturing clinical supplies and establishing commercial supplies of our product candidates and any other products we may develop; · The cost, timing and outcomes of regulatory approvals; · The costs and timing of establishing sales, marketing and distribution capabilities; · The terms and timing of any collaborative, licensing and other arrangements that we may establish, including any required milestone and royalty payments thereunder; · The emergence of competing technologies or other adverse market developments; and · The potential cost and timing of managing, protecting, defending and enforcing our portfolio of intellectual property.
Our future funding requirements will depend on many factors, including but not limited to the following: · The scope, rate of progress, results and cost of our preclinical and clinical studies and other related activities, according to our long-term strategic plan; · The cost of manufacturing clinical supplies and establishing commercial supplies of our product candidates and any other products we may develop; 126 Table of Contents · The cost, timing and outcomes of regulatory approvals; · The costs and timing of establishing sales, marketing and distribution capabilities; · The terms and timing of any collaborative, licensing and other arrangements that we may establish, including any required milestone and royalty payments thereunder; · The emergence of competing technologies or other adverse market developments; and · The potential cost and timing of managing, protecting, defending and enforcing our portfolio of intellectual property.
Under the terms of the agreement, AC Immune received an upfront payment of USD 100 (CHF 92.3) million in May 2024 and is eligible to receive an option exercise fee and additional potential development, commercial and sales-based milestones of up to approximately USD 2.1 (CHF 1.9) billion if all related milestones are achieved over the course of the agreement.
Under the terms of the agreement, AC Immune received an upfront payment of USD 100 (CHF 92.3) million in May 2024 and is eligible to receive an option exercise fee and additional potential development, commercial and sales-based milestones of up to approximately USD 2.1 (CHF 1.7) billion if all related milestones are achieved over the course of the agreement.
We expect that any revenue we generate from our collaboration agreements with each of Lilly, Janssen, LMI, Takeda and/or from any other current or future collaboration partners will fluctuate from year to year as a result of the timing and amount of milestones and other payments.
We expect that any revenue we generate from our collaboration agreements with each of Lilly, Janssen, Lantheus, Takeda and/or from any other current or future collaboration partners will fluctuate from year to year as a result of the timing and amount of milestones and other payments.
Research and development expenses represent costs incurred to conduct research, such as the discovery and development of our product candidates, as well as development of new product candidates from our SupraAntigen and Morphomer platforms and the development of product candidates pursuant to our collaboration agreements with Lilly, Janssen, LMI and Takeda.
Research and development expenses represent costs incurred to conduct research, such as the discovery and development of our product candidates, as well as development of new product candidates from our SupraAntigen and Morphomer platforms and the development of product candidates pursuant to our collaboration agreements with Lilly, Janssen, Lantheus and Takeda.
In addition, for a second indication, clinical milestone payments would be payable upon commencement of a Phase 3 clinical study, which would be payable concurrently with the first regulatory milestone, if Janssen were to file for regulatory approval based on Phase 2 clinical data. ● Regulatory milestone payments : payable upon making regulatory filings in the U.S., Europe, and Japan, respectively.
In addition, for a second indication, clinical milestone payments would be payable upon commencement of a Phase 3 clinical study, which would be payable concurrently with the first regulatory milestone, if Janssen were to file for regulatory approval based on Phase 2 clinical data. 115 Table of Contents ● Regulatory milestone payments : payable upon making regulatory filings in the U.S., Europe, and Japan, respectively.
Our actual results may differ materially from those anticipated in these forward-looking statements as a result of many factors, 122 Table of Contents including but not limited to those described under “Item 3. Key information—D. Risk factors” and elsewhere in this Annual Report. A.
Our actual results may differ materially from those anticipated in these forward-looking statements as a result of many factors, including but not limited to those described under “Item 3. Key information—D. Risk factors” and elsewhere in this Annual Report. A.
In August 2022, the Company received follow-on grant funding as part of its joint arrangement with Skåne totaling USD 0.5 (CHF 0.5) million for the continued development of its alpha-synuclein PET imaging diagnostic agent. As part of this grant, the Company received USD 0.4 (CHF 0.4) million directly from the MJFF.
In August 2022, the Company received follow-on grant funding as part of its joint arrangement with Skåne totaling USD 0.5 (CHF 0.5) million for the continued development of its alpha-synuclein PET imaging diagnostic agent. As part of this grant, the Company received USD 0.4 (CHF 0.4) million directly from the 118 Table of Contents MJFF.
Research and development expenses Research and development costs are expensed as incurred, and consist of salaries and benefits, laboratory supplies, materials, intellectual property, facility and information technology (IT) costs, as well as fees paid to other non- 132 Table of Contents employees and entities that conduct certain research and development activities on our behalf and all other allocated expenses.
Research and development expenses Research and development costs are expensed as incurred, and consist of salaries and benefits, laboratory supplies, materials, intellectual property, facility and information technology (IT) costs, as well as fees paid to other non-employees and entities that conduct certain research and development activities on our behalf and all other allocated expenses.
The development, CMC, and regulatory activities are treated as one distinct performance obligation because the underlying activities are not distinguishable in the context of the contract and are inputs to an integrated development program that will generate valuable data and information for Takeda in determining whether to exercise the option.
The development, CMC, and regulatory activities are 117 Table of Contents treated as one distinct performance obligation because the underlying activities are not distinguishable in the context of the contract and are inputs to an integrated development program that will generate valuable data and information for Takeda in determining whether to exercise the option.
Notwithstanding the corporate income tax, the corporate capital is taxed at a rate of 0.1305% (cantonal and communal tax only, as there is no federal tax on capital). 134 Table of Contents Value added tax (VAT) is charged on all qualifying goods and services supplied by VAT-registered businesses.
Notwithstanding the corporate income tax, the corporate capital is taxed at a rate of 0.1305% (cantonal and communal tax only, as there is no federal tax on capital). Value added tax (VAT) is charged on all qualifying goods and services supplied by VAT-registered businesses.
The Company 127 Table of Contents will recognize revenue related to the development, CMC and regulatory performance obligation over the estimated period of completion of these obligations, using an input method reflecting the costs incurred relative to the total costs expected to be incurred.
The Company will recognize revenue related to the development, CMC and regulatory performance obligation over the estimated period of completion of these obligations, using an input method reflecting the costs incurred relative to the total costs expected to be incurred.
If not otherwise terminated, the agreement shall continue until the expiration of all royalty obligations as outlined in the contract. LMI (formerly Piramal Imaging SA) Tau-PET imaging agent – 2014 agreement In May 2014 (as amended in June 2022), we entered into an agreement, our first diagnostic partnership, with LMI, the former Piramal Imaging SA.
If not otherwise terminated, the agreement shall continue until the expiration of all royalty obligations as outlined in the contract. Life Molecular Imaging (formerly Piramal Imaging SA) Tau-PET imaging agent – 2014 agreement In May 2014 (as amended in June 2022), we entered into an agreement, our first diagnostic partnership, with Life Molecular Imaging (formerly Piramal Imaging SA.
The partnership with LMI is an exclusive, worldwide licensing agreement for the research, development and commercialization of the Company’s Tau protein PET tracers supporting the early diagnosis and clinical management of AD and other Tau-related disorders and includes upfront and sales milestone payments totaling up to EUR 160 (CHF 152) million, plus royalties on sales at a percentage rate ranging from mid-single digits to low-teens.
The partnership with Life Molecular Imaging is an exclusive, worldwide licensing agreement for the research, development and commercialization of the Company’s Tau protein PET tracers supporting the early diagnosis and clinical management of AD and other Tau-related disorders and includes upfront and sales milestone payments totaling up to EUR 160 (CHF 150) million, plus royalties on sales at a percentage rate ranging from mid-single digits to low-teens.
Operating results—results of operations.” D. Trend information See “Item 5. Operating and financial review and prospects.” E. Critical Accounting Estimates We prepare our consolidated financial statements in accordance with IFRS as issued by the IASB. See “Note 3.
Operating results—results of operations.” 127 Table of Contents D. Trend information See “Item 5. Operating and financial review and prospects.” E. Critical Accounting Estimates We prepare our consolidated financial statements in accordance with IFRS Accounting Standards as issued by the IASB. See “Note 3.
General and administrative expenses General and administrative expenses consist primarily of salaries and related costs, including share-based compensation, professional fees such as legal and accounting related services, infrastructure expenses, and other operating expenses. For the year ended December 31, 2024, general and administrative expenses totaled CHF 17.3 million compared with CHF 15.3 million for the comparable period in 2023.
General and administrative expenses General and administrative expenses consist primarily of salaries and related costs, including share-based compensation, professional fees such as legal and accounting related services, infrastructure expenses, and other operating expenses. For the year ended December 31, 2025, general and administrative expenses totaled CHF 16.1 million compared with CHF 17.3 million for the comparable period in 2024.
The Company was awarded an additional one-year grant in December 2022 128 Table of Contents for USD 0.1 (CHF 0.1) million to continue the project, which was completed in 2023. Subsequently, in December 2023, AC Immune was awarded another one-year grant for the same amount, USD 0.1 (CHF 0.1) million, to continue its work.
The Company was awarded an additional one-year grant in December 2022 for USD 0.1 (CHF 0.1) million to continue the project, which was completed in 2023. Subsequently, in December 2023, AC Immune was awarded another one-year grant for the same amount, USD 0.1 (CHF 0.1) million, to continue its work.
We are entitled under Swiss laws to carry forward any losses incurred for a period of 7 years and can offset our losses carried forward against future taxes. As of December 31, 2024, we had tax loss carry-forwards totaling CHF 343.6 million (provisional amount; tax loss is definitively recognized by Swiss tax authorities once set-off against taxable income).
We are entitled under Swiss laws to carry forward any losses incurred for a period of 7 years and can offset our losses carried forward against future taxes. As of December 31, 2025, we had tax loss carry-forwards totaling CHF 362.3 million (provisional amount; tax loss is definitively recognized by Swiss tax authorities once set-off against taxable income).
Summary of material accounting policies” to our consolidated financial statements for a description of the most significant accounting policies applied in the preparation of our consolidated financial statements. 141 Table of Contents
Summary of material accounting policies” to our consolidated financial statements for a description of the most significant accounting policies applied in the preparation of our consolidated financial statements.
Comparison of the years ended December 31, 2023 and 2022 For a discussion of the financial results and condition for the fiscal year ended December 31, 2022, please refer to “Item 5. Operating and financial review and prospects—A.
Comparison of the years ended December 31, 2024 and 2023 For a discussion of the financial results and condition for the fiscal year ended December 31, 2023, please refer to “Item 5. Operating and financial review and prospects—A. Operating results—Comparison of the years ended December 31, 2024 and 2023” and “Item 5. Operating and financial review and prospects—B.
Personnel costs consist of salaries, cash bonuses, benefits and share-based compensation. Outside professional services consist of legal, accounting and audit services, IT and other consulting fees. Allocated expenses consist of certain IT, facilities and depreciation expenses.
General and administrative expenses General and administrative expenses include personnel costs, expenses for outside professional services and all other allocated expenses. Personnel costs consist of salaries, cash bonuses, benefits and share-based compensation. Outside professional services consist of legal, accounting and audit services, IT and other consulting fees. Allocated expenses consist of certain IT, facilities and depreciation expenses.
In Q1 2020, the Company and Lilly entered into a second amendment to replace the second CHF 30 million to be paid on or before March 31, 2020 with two milestone payments, one of CHF 10 million to be paid on or before March 31, 2020 and the other of CHF 60 million following the first patient dosed in a Phase 2 clinical study of a licensed product in the U.S. or the EU.
In Q1 2020, the Company and Lilly entered into a second amendment to replace the second CHF 30 million to be paid on or before March 31, 2020 with two milestone payments, one of CHF 10 million to be paid on or before March 31, 2020 and the other of CHF 60 million following the first patient dosed in a Phase 2 clinical study of a licensed product in the U.S. or the EU. 116 Table of Contents The Company received an initial upfront payment of CHF 80 million in February 2019.
The following table summarizes our contract revenues during the years ended December 31, 2024 and 2023: ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ For the Year Ended ​ ​ ​ ​ December 31, ​ ​ In CHF thousands ​ 2024 ​ 2023 ​ Change Contract revenue 27,309 ​ 14,801 12,508 Total revenue 27,309 14,801 12,508 ​ Our contract revenues experience fluctuations as a result of securing new collaboration agreements, the timing of milestone achievements and the size of each milestone payment.
The following table summarizes our contract revenues during the years ended December 31, 2025 and 2024: ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ For the Year Ended ​ ​ ​ ​ December 31, ​ ​ In CHF thousands ​ 2025 ​ 2024 ​ Change Contract revenue ​ ​ ​ 3,573 ​ 27,309 ​ ​ ​ (23,736) Total revenue 3,573 27,309 (23,736) ​ Our contract revenues experience fluctuations as a result of securing new collaboration agreements, the timing of milestone achievements and the size of each milestone payment.
The research and development costs not allocated to specific programs include employment costs, regulatory, QA and intellectual property costs.
The research and development costs 122 Table of Contents not allocated to specific programs include employment costs, regulatory, QA and intellectual property costs.
Operating results—Comparison of the years ended December 31, 2023 and 2022” of our Annual Report on Form 20-F for the year ended December 31, 2023 filed on March 14, 2024. C. Research and development, patents and licenses, etc. See “Item 4. Information on the Company—B. Business overview” and “Item 5. Operating and financial review and prospects—A.
Liquidity and capital resources—Comparison of the years ended December 31, 2024 and 2023” of our Annual Report on Form 20-F for the year ended December 31, 2024 filed on March 13, 2025. C. Research and development, patents and licenses, etc. See “Item 4. Information on the Company—B. Business overview” and “Item 5. Operating and financial review and prospects—A.
The research and development activities were delivered over time as the services were performed. For these services, revenue was recognized over time using the input method, based on costs incurred to perform the services, as the level of costs incurred over time is thought to best reflect the transfer of services to Lilly.
For these services, revenue was recognized over time using the input method, based on costs incurred to perform the services, as the level of costs incurred over time is thought to best reflect the transfer of services to Lilly.
Investing activities Net cash used in investing activities was CHF 105.3 million for the year ended December 31, 2024 compared with net cash provided by investing activities of CHF 65.6 million for the year ended December 31, 2023.
Investing activities Net cash provided by investing activities was CHF 63.5 million for the year ended December 31, 2025 compared with net cash used in investing activities of CHF 105.3 million for the year ended December 31, 2024.
Right-of-use assets, long-term financial assets and lease liabilities.” The Company currently projects CHF 1.5 million in undiscounted short-term lease obligations and CHF 4.7 million in undiscounted long-term lease obligations. Additionally, the Company projects CHF 27.3 million in short-term purchase commitments and CHF 15.7 million in long-term purchase commitments predominantly driven by R&D activities.
Right-of-use assets, long-term financial assets and lease liabilities.” The Company currently projects CHF 1.4 million in undiscounted short-term lease obligations and CHF 4.2 million in undiscounted long-term lease obligations. Additionally, the Company projects CHF 26.4 million in short-term purchase commitments and CHF 29.8 million in long-term purchase commitments predominantly driven by R&D activities.
In July 2024, JNJ-2056 was granted Fast Track designation from the FDA, for the treatment of AD. The Company received an upfront, non-refundable license fee of CHF 25.9 million, which we recognized as revenue in 2014.
In July 2024, JNJ-2056 was granted Fast Track designation from the FDA, for the treatment of AD. The Company received an upfront, non-refundable license fee of CHF 25.9 million, which we recognized as revenue in 2014. In May 2016, we received a payment of CHF 4.9 million for reaching a clinical milestone in the Phase 1b study.
Financing activities Net cash used in financing activities was CHF 1.1 million for the year ended December 31, 2024, compared with net cash provided by financing activities of CHF 43.3 million for the year ended December 31, 2023.
Financing activities Net cash used in financing activities was CHF 1.0 million for the year ended December 31, 2025, compared with net cash used in financing activities of CHF 1.1 million for the year ended December 31, 2024.
These terminations became effective in April 2024 and the Company regained the global rights to crenezumab and semorinemab in February 2025. Anti-Abeta antibody in AD – 2006 agreement In November 2006, we signed an exclusive, worldwide licensing agreement for crenezumab, our humanized monoclonal therapeutic antibody targeting misfolded Abeta.
Anti-Abeta antibody in AD – 2006 agreement In November 2006, we signed an exclusive, worldwide licensing agreement for crenezumab, our humanized monoclonal therapeutic antibody targeting misfolded Abeta. The agreement was amended March 2009, January 2013, May 2014 and May 2015. The collaboration agreement was terminated effective April 2024 and the Company regained the global rights to crenezumab in February 2025.
The change in cash used in operating activities for the year ended December 31, 2024 was mostly due to (i) an increase of CHF 89.6 million in deferred contract revenue, resulting from the receipt of the upfront payment from our agreement with Takeda, (ii) a decrease of CHF 14.8 million in account receivable for the period, which relates to the milestone recognized from Janssen and (iii) the Company’s reporting a net loss of CHF 50.9 million for the year ended December 31, 2024 compared with net loss of CHF 54.2 million for the same period in 2023.
The change in cash used in operating activities for the year ended December 31, 2025 was mostly due to (i) the Company’s reporting a net loss of CHF 70.4 million for the year ended December 31, 2025 compared with net loss of CHF 50.9 million for the same period in 2024 as a result of the agreement with Takeda yielding a CHF 92.3 million cash receipt in 2024, and (ii) a decrease of CHF 14.8 million in account receivable in 2024 as a result of the payment of the milestone recognized from Janssen in 2023.
Costs for certain development activities, such as clinical trials, are recognized based on an evaluation of the progress to completion of specific tasks using information from the clinical sites and our vendors. Our collaboration agreements have different agreements to share costs for the development of our product candidates.
Research and development expenses Research and development activities are essential to our business and represent the majority of our costs incurred. Costs for certain development activities, such as clinical trials, are recognized based on an evaluation of the progress to completion of specific tasks using information from the clinical sites and our vendors.
For the year ended December 31, 2024, research and development expenses totaled CHF 62.6 million compared with CHF 54.6 million for the comparable period in 2023. This represents an increase of CHF 8.0 million.
For the year ended December 31, 2025, research and development expenses totaled CHF 56.4 million compared with CHF 62.6 million for the comparable period in 2024. This represents a decrease of CHF 6.1 million.
The agreement was amended March 2009, January 2013, May 2014 and May 2015. The collaboration agreement was terminated effective April 2024 and the Company regained the global rights to crenezumab in February 2025.
The agreement was amended in December 2015. This collaboration agreement was terminated effective April 2024 and the Company regained the global rights to semorinemab in February 2025.
This represents an increase of CHF 2.1 million.
This represents a decrease of CHF 1.2 million.
Exchange differences consist of foreign exchange transactions and re-measurement gains and losses that arise from our cash being held in currency other than Swiss Francs, certain collaboration agreements such as the collaboration agreements with LMI or Takeda being denominated in currencies other than Swiss Francs, and selected purchases, which we effect in foreign currencies.
Finance result, net Financial income and expenses include bank fees associated with charges levied by banks on foreign payments, interest income and expense associated with our cash balances and interest expense associated with lease liabilities. 120 Table of Contents Exchange differences consist of foreign exchange transactions and re-measurement gains and losses that arise from our cash being held in currency other than Swiss Francs, certain collaboration agreements such as the collaboration agreements with LMI or Takeda being denominated in currencies other than Swiss Francs, and selected purchases, which we effect in foreign currencies.
The Company received an initial upfront payment of CHF 80 million in February 2019. We used the residual approach to estimate the selling price for the right-of-use license and an expected cost plus margin approach for estimating the research and development activities. The right-of-use license was delivered on the effective date.
We used the residual approach to estimate the selling price for the right-of-use license and an expected cost plus margin approach for estimating the research and development activities. The right-of-use license was delivered on the effective date. The research and development activities were delivered over time as the services were performed.
From Phase 2b and onwards, Janssen will assume responsibility for the clinical development, manufacturing and commercialization. 135 Table of Contents We intend to increase our R&D costs associated with the advancement of our active immunotherapies, ACI-24.060 targeting Abeta in AD and AD in DS and ACI-7104.056 targeting a-syn in PD, through mid- and late-stage clinical development, as well as through investments in our diagnostic programs.
We intend to increase our R&D costs associated with the advancement of our active immunotherapies, ACI-24.060 targeting Abeta and ACI-7104.056 targeting a-syn in PD, through mid- and late-stage clinical development, as well as through investments in our intracellular programs such as our NLRP3 inhibitor, ACI-19764.
ATM program Commencing in September 2020, the Company established an “at the market offering” (ATM) for the sale of up to USD 80.0 (CHF 73.0) million worth of our common shares from time to time by entering into an Open Market Sale Agreement (Sales Agreement) with Jefferies LLC (Jefferies). 140 Table of Contents In Q2 2021 and Q2 2024, we filed a new registration statement on Form F-3 and entered into a new Sales Agreement in Q2 2021 and Q3 2024 to replace and extend the ATM program.
ATM program Commencing in September 2020, the Company established an “at the market offering” (ATM) for the sale of up to USD 80.0 (CHF 64.0) million worth of our common shares from time to time by entering into an Open Market Sale Agreement (Sales Agreement) with Jefferies LLC (Jefferies).
The following table presents the finance result during the years ended December 31, 2024 and 2023: ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ For the Year Ended ​ ​ ​ ​ December 31, ​ ​ In CHF thousands ​ 2024 ​ 2023 ​ Change Financial income ​ 3,196 1,044 2,152 Financial expense ​ (133) (176) 43 Exchange differences ​ (1,598) (1,467) (131) Finance result, net ​ 1,465 (599) 2,064 ​ The change in net finance result of CHF 2.1 million primarily related to an increase of CHF 2.2 million in financial income attributed to higher interest received on net investments in short-term financial assets, with more deposits made in 2024 compared to the previous period. ​ 138 Table of Contents B.
The following table presents the finance result during the years ended December 31, 2025 and 2024: ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ For the Year Ended ​ ​ ​ ​ December 31, ​ ​ In CHF thousands ​ 2025 ​ 2024 ​ Change Financial income ​ 1,865 ​ ​ ​ 3,196 ​ ​ ​ (1,331) Financial expense ​ (191) (133) (58) Exchange differences ​ (2,803) (1,598) (1,205) Finance result, net ​ (1,129) 1,465 (2,594) ​ The unfavorable change in finance result, net of CHF 2.6 million primarily related to a decrease of CHF 1.3 million in financial income attributed to lower interest received on net investments in short-term financial assets, with less deposits made in 2025 compared to the previous period.
Liquidity and capital resources Cash flows Comparison of the years ended December 31, 2024 and 2023 The following table summarizes our cash flows for the periods indicated: ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ For the Year Ended ​ ​ December 31, ​ ​ In CHF thousands ​ 2024 ​ 2023 ​ Change Net cash provided by/(used in): ​ Operating activities ​ 65,842 (60,408) 126,250 Investing activities ​ (105,290) 65,645 (170,935) Financing activities ​ (1,120) 43,250 (44,370) Net increase/(decrease) in cash and cash equivalents ​ (40,568) 48,487 (89,055) ​ Operating activities Net cash provided by operating activities was CHF 65.8 million for the year ended December 31, 2024 compared with net cash used in operating activities of CHF 60.4 million for the year ended December 31, 2023.
Liquidity and capital resources Cash flows Comparison of the years ended December 31, 2025 and 2024 The following table summarizes our cash flows for the periods indicated: ​ ​ ​ ​ ​ ​ ​ ​ ​ For the Year Ended ​ ​ ​ ​ ​ ​ ​ ​ December 31, ​ ​ In CHF thousands ​ 2025 ​ 2024 ​ Change Net cash provided by/(used in): ​ ​ ​ ​ Operating activities ​ (69,262) 65,842 (135,104) Investing activities ​ 63,542 (105,290) 168,832 Financing activities ​ (1,020) (1,120) 100 Net increase/(decrease) in cash and cash equivalents ​ (6,740) (40,568) 33,828 ​ 125 Table of Contents Operating activities Net cash used in operating activities was CHF 69.3 million for the year ended December 31, 2025 compared with net cash provided by operating activities of CHF 65.8 million for the year ended December 31, 2024.
Additionally, manufacturing costs incurred after regulatory approval but in connection with significant changes and/or enhancements to the approved manufacturing process are recorded as research and development expenses. We accrue and expense the manufacturing activities performed by third parties based upon actual work completed in accordance with agreements established with contract manufacturers.
Additionally, manufacturing costs incurred after regulatory approval but in connection with significant changes and/or enhancements to the approved manufacturing process are recorded as research and development expenses.
Total salaries and related costs increased by CHF 1.0 million, primarily due to the annualization of 2023 hires and additional new hires during the year, which resulted in an increase in salary- and benefit-related costs of CHF 0.7 million, and CHF 0.3 million in share-based compensation expense. The decrease in other non-allocated expenses relates to certain non-allocated functional expenses.
Total salaries and related costs decreased by CHF 0.7 million, primarily due to decreased share-based compensation in the current year. The increase in other non-allocated expenses relates to certain non-allocated functional expenses.
We have received total milestone payments of USD 65 (CHF 70.1) million comprised of an upfront payment of USD 25 (CHF 31.6) million and of USD 40 (CHF 38.2) million for clinical development milestones achieved, all prior to January 1, 2017.
We have received total milestone payments of USD 65 (CHF 70.1) million comprised of an upfront payment of USD 25 (CHF 31.6) million and of USD 40 (CHF 38.2) million for clinical development milestones achieved, all prior to January 1, 2017. 114 Table of Contents Anti-Tau antibody in AD – 2012 agreement In June 2012, we entered into a second agreement with Genentech to research, develop and commercialize our anti-Tau antibodies for use as immunotherapeutics and diagnostics.
As of December 31, 2024, we had cash and cash equivalents of CHF 36.3 million and short-term financial assets of CHF 129.2 million, resulting in CHF 165.5 million of liquidity.
As of December 31, 2025, we had cash and cash equivalents of CHF 26.8 million and short-term financial assets of CHF 64.6 million, resulting in CHF 91.4 million of liquidity.
The following table presents the general and administrative expenses during the years ended December 31, 2024 and 2023: ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ For the Year Ended ​ ​ December 31, ​ ​ In CHF thousands ​ 2024 ​ 2023 ​ Change Operating expenses 1 ​ 5,825 4,729 1,096 Salaries and related costs 2 ​ 11,434 10,576 858 Total general and administrative expenses ​ 17,259 15,305 1,954 1 Includes depreciation expenses 2 Includes share-based compensation For the year ended December 31, 2024, this increase is primarily due to: ● an increase of CHF 1.1 million in operating expenses, predominantly due to a rise in legal fees related to business development and licensing activities; and ● an increase of CHF 0.9 million in salaries and related costs, mainly due to new hires during the year, which resulted in an increase in salary- and benefit-related costs of CHF 0.5 million.
The following table presents the general and administrative expenses during the years ended December 31, 2025 and 2024: ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ For the Year Ended ​ ​ ​ ​ ​ ​ ​ ​ December 31, ​ ​ In CHF thousands ​ 2025 ​ 2024 ​ Change Operating expenses 1 ​ 4,442 5,825 (1,383) Salaries and related costs 2 ​ 11,652 11,434 218 Total general and administrative expenses ​ 16,094 17,259 (1,165) 1 Includes depreciation expenses of CHF 1.6 million 2 Includes share-based compensation CHF 3.1 million For the year ended December 31, 2025, this decrease is primarily due to: ● a decrease of CHF 1.4 million in operating expenses, largely driven by a CHF 1.0 million decrease in legal fees.
Results of operations The numbers below have been derived from our audited consolidated financial statements included elsewhere in this Annual Report. The discussion below should be read along with these consolidated financial statements and it is qualified in its entirety by reference to them.
Results of operations The numbers below have been derived from our audited consolidated financial statements included elsewhere in this Annual Report.
Our investment in research and development activities, including the clinical development of our product candidates has historically been, and is projected to be, more than 75% of our total annual operating costs.
We accrue and expense the manufacturing activities performed by third parties based upon actual work completed in accordance with agreements established with contract manufacturers. 119 Table of Contents Our investment in research and development activities, including the clinical development of our product candidates has historically been, and is projected to be, more than 75% of our total annual operating costs.
We have completed our co-development costs with Janssen for the Phase 1b/2a studies for our active immunotherapy, ACI-35.030 and JACI-35.054. AC Immune and Janssen will jointly share research and development costs for the first Phase 2b (however, AC Immune’s contribution to the first Phase 2b trial is capped (and remaining costs for AC Immune are non-material).
AC Immune and Janssen will jointly share research and development costs for the first Phase 2b (however, AC Immune’s contribution to the first Phase 2b trial is capped (and remaining costs for AC Immune are non-material). From Phase 2b and onwards, Janssen will assume responsibility for the clinical development, manufacturing and commercialization.
Since our inception, we have received upfront and milestone payments from our collaboration partners and certain other revenue. However, we have also incurred significant operating losses. We incurred net losses of CHF 50.9 million for the fiscal year ended December 31, 2024 and have an accumulated losses balance of CHF 368.2 million as of December 31, 2024.
Since our inception, we have received upfront and milestone payments from our collaboration partners and certain other revenue. However, we have also incurred significant operating losses.
In October 2024, the Company received the second ReTain-related milestone payment of CHF 24.6 million under its agreement with Janssen. This milestone payment was triggered by the rapid rate of prescreening in the potentially registrational Phase 2b ReTain trial investigating active-immunotherapy candidate ACI-35.030/JNJ-2056 to treat preclinical (pre-symptomatic) AD.
This milestone payment was triggered by the rapid rate of prescreening in the potentially registrational Phase 2b ReTain trial investigating active-immunotherapy candidate ACI-35.030/JNJ-2056 to treat preclinical (pre-symptomatic) AD. The Company recognized this milestone payment as revenue because we deemed it highly probable that this milestone would be obtained and would not be subject to reversal in the future.
Other operating income/(expense), net For the year ended December 31, 2024, other operating income/(expense), net totaled CHF 0.1 million in income compared with CHF 1.5 million in income for the comparable period in 2023. This represents a decrease of CHF 1.4 million.
Other operating income/(expense), net Other operating income/(expense), net totaled CHF 0.1 million in income for the years ended December 31, 2025 and 2024.
Our contract revenues to date have been derived primarily from separate option, license and collaboration agreements on some of our product candidates in various stages of preclinical and clinical development. Our contract revenues have experienced fluctuations over the past three years as a result of the timing of milestone achievement and the size of each milestone payment.
Our contract revenues have experienced fluctuations over the past three years as a result of the timing of milestone achievement and the size of each milestone payment.
Following option exercise and the satisfaction of customary closing conditions, Takeda would conduct and fund all further clinical development and be responsible for all global regulatory activities as well as worldwide commercialization. 123 Table of Contents Genentech, a member of the Roche Group As mentioned above, the Company announced that the development of crenezumab and semorinemab in the collaboration agreements with Genentech was terminated.
AC Immune will be responsible for completing the ABATE trial. Following option exercise and the satisfaction of customary closing conditions, Takeda would conduct and fund all further clinical development and be responsible for all global regulatory activities as well as worldwide commercialization.
In May 2016, we received a payment of CHF 4.9 million for reaching a clinical milestone in the Phase 124 Table of Contents 1b study. In February 2024, we received a milestone payment of CHF 14.8 million for the commencement of the first Phase 2b clinical study.
In February 2024, we received a milestone payment of CHF 14.8 million for the commencement of the first Phase 2b clinical study. In October 2024, the Company received the second ReTain-related milestone payment of CHF 24.6 million under its agreement with Janssen.
Other operating income/(expense), net Other operating income/(expense) consists primarily of income associated with foundation grants such as those from the MJFF or Target ALS. Finance result, net Financial income and expenses include bank fees associated with charges levied by banks on foreign payments, interest income and expense associated with our cash balances and interest expense associated with lease liabilities.
Other operating income/(expense), net Other operating income/(expense) consists primarily of income associated with foundation grants such as those from the MJFF or Target ALS.
A net amount of CHF 104.7 million of short-term financial assets was invested during the financial year ended December 31, 2024, compared to a net maturation of CHF 66.4 million of short-term financial assets in the prior period. Additionally, the Company spent CHF 0.6 million on property, plant and equipment, predominantly to enhance its laboratory and IT equipment in 2024.
The change was composed of a net maturation of CHF 64.6 million of short-term financial assets during the financial year ended December 31, 2025, compared to a net investment of CHF 104.7 million of short-term financial assets in the prior year.
The following table presents the research and development expenses during the years ended December 31, 2024 and 2023: Detailed research and development expenditures by major development category ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ For the Year Ended ​ ​ ​ December 31, ​ ​ In CHF thousands ​ 2024 ​ 2023 ​ Change Discovery and preclinical expenses ​ 9,366 11,117 (1,751) Clinical expenses ​ 19,850 11,095 8,755 Group function expenses ​ 1,986 1,363 623 Total direct R&D expenses ​ 31,202 23,575 7,627 Payroll expenses ​ 20,195 19,499 696 Share-based compensation ​ 2,212 1,909 303 Other non-allocated ​ 8,961 9,623 (662) Total R&D expenses ​ 62,570 54,606 7,964 ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ For the Year Ended ​ ​ ​ ​ December 31, ​ ​ In CHF thousands ​ 2024 ​ 2023 ​ Change Operating expenses 1 ​ 40,163 33,198 6,965 Salaries and related costs 2 ​ 22,407 21,408 999 Total R&D expenses ​ 62,570 54,606 7,964 1 Includes depreciation expenses 2 Includes share-based compensation For the year ended December 31, 2024: Discovery and preclinical expenses decreased by CHF 1.8 million, primarily due to: ● the completion of pre-clinical TOX studies in the TDP-43 monoclonal antibody, lower spending in PET imaging programs, and our strategic focus on advancing clinical-stage programs.
The following table presents the research and development expenses during the years ended December 31, 2025 and 2024: Detailed research and development expenditures by major development category ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ For the Year Ended ​ ​ ​ ​ ​ ​ December 31, ​ ​ In CHF thousands ​ 2025 ​ 2024 ​ Change Discovery and preclinical expenses ​ 7,812 9,366 (1,554) Clinical expenses ​ 15,464 19,850 (4,386) Group function expenses ​ 1,942 1,986 (44) Total direct R&D expenses ​ 25,218 31,202 (5,984) Payroll expenses ​ 20,213 20,195 18 Share-based compensation ​ 1,447 2,212 (765) Other non-allocated ​ 9,558 8,961 597 Total R&D expenses ​ 56,436 62,570 (6,134) ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ For the Year Ended ​ ​ ​ ​ December 31, ​ ​ In CHF thousands ​ 2025 ​ 2024 ​ Change Operating expenses 1 ​ 34,776 ​ ​ ​ 40,163 ​ ​ ​ (5,387) Salaries and related costs 2 ​ 21,660 22,407 (747) Total R&D expenses ​ 56,436 62,570 (6,134) 1 Includes depreciation expenses of CHF 0.9 million. 2 Includes share-based compensation of CHF 1.4 million.
Strategic collaborations and licensing agreements Since our inception, we have entered into strategic collaboration agreements with a range of partners covering a number of our product candidates.
We incurred net losses of CHF 70.4 million for the fiscal year ended December 31, 2025 and have an accumulated losses balance of CHF 439.0 million as of December 31, 2025. 113 Table of Contents Strategic collaborations and licensing agreements Since our inception, we have entered into strategic collaboration agreements with a range of partners covering a number of our product candidates.
This was partially offset by 139 Table of Contents R&D spending on our major discovery and R&D programs, the strengthening of the Company’s infrastructure, systems and organization and other operating expenditures. We believe that our existing capital resources, assuming no other milestone payment, will be sufficient to meet our projected operating requirements into Q1 2027.
We believe that our existing capital resources, assuming no other milestone payment, will be sufficient to meet our projected operating requirements until the end of Q3 2027.
Comparison of the years ended December 31, 2024 and 2023 Contract revenue For the year ended December 31, 2024, AC Immune generated CHF 27.3 million in contract revenues compared with CHF 14.8 million for the comparable period in 2023. This represents an increase of CHF 12.5 million.
The discussion below should be read along with these consolidated financial statements and it is qualified in its entirety by reference to them. 121 Table of Contents Comparison of the years ended December 31, 2025 and 2024 Contract revenue For the year ended December 31, 2025, AC Immune generated CHF 3.6 million in contract revenues compared with CHF 27.3 million for the comparable period in 2024.
The variances in Group function expenses relate to regulatory and quality assurance, intellectual property and other non-allocated costs across various cost centers.
These changes were offset by increased costs associated with our NLRP3 inhibitor program, which is expected to enter clinical development in 2026, and higher costs associated with our PET Tracer programs which entered clinical development in 2025. 123 Table of Contents The variances in Group function expenses relate to regulatory and quality assurance, intellectual property and other non-allocated costs across various cost centers.
Clinical expenses increased by CHF 8.8 million, primarily due to: ● an increase of CHF 7.2 million in our ACI-24.060 active immunotherapy for expansion of the ABATE study, an increase of CHF 2.1 million attributed to the ramp-up of activities for our Phase 2 VacSYn study evaluating ACI-7104.056 in early PD and an increase of CHF 0.3 million in other clinical programs. partially offset by: ● a decrease of CHF 0.8 million for the clinical development of ACI-35.030 driven by the completion of the Phase 1b/2a and the advancement into Phase 2b, where the costs are borne by Janssen.
Clinical expenses decreased by CHF 4.4 million, primarily due to: ● a decrease of CHF 2.1 million related to our Phase 2 VacSYn study evaluating ACI-7104.056 in early PD, primarily related to manufacturing activities incurred in the prior period which did not recur in the current period, and a decrease of CHF 4.1 million in our other active immunotherapy program, mostly due to manufacturing costs not recurring in the current period, and Clinical development activities.
Net interest expense/(income) and other expenses related to defined benefit plans are recognized in the consolidated statements of income/(loss). Financial operations overview Contract revenues Given our stage of development, we have not generated any revenue from product sales.
Financial operations overview Contract revenues Given our stage of development, we have not generated any revenue from product sales. Our contract revenues to date have been derived primarily from separate option, license and collaboration agreements on some of our product candidates in various stages of preclinical and clinical development.
Finally, we intend to further advance the characterization of our other clinical and preclinical candidates, such as our Morphomer Tau program.
Finally, we intend to further advance the characterization of our other clinical and preclinical candidates, such as our Morphomer programs. In addition to the collaborative arrangements and proprietarily held assets, we expect that our total future R&D costs will be lower than previous years following the reorganization in September 2025.
This represents an increase of CHF 2.0 million.
This represents a decrease of CHF 23.7 million.
For the year ended December 31, 2023, our contract revenues of CHF 14.8 million were related to the commencement of the first Phase 2b clinical study of ACI-35.056 per our agreement with Janssen. Research and development expenses Research and development activities are essential to our business and represent the majority of our costs incurred.
For the year ended December 31, 2025, our contract revenues of CHF 3.6 million were related to the efforts made under the agreement with Takeda for the development, CMC (chemistry, manufacturing, and controls), and regulatory activities.
Anti-Tau antibody in AD – 2012 agreement In June 2012, we entered into a second agreement with Genentech to research, develop and commercialize our anti-Tau antibodies for use as immunotherapeutics and diagnostics. The agreement was amended in December 2015. This collaboration agreement was terminated effective April 2024 and the Company regained the global rights to semorinemab in February 2025.
Genentech, a member of the Roche Group As mentioned above, the Company announced that the development of crenezumab and semorinemab in the collaboration agreements with Genentech was terminated. These terminations became effective in April 2024 and the Company regained the global rights to crenezumab and semorinemab in February 2025.
Removed
AC Immune will be responsible for completing the ABATE trial.
Added
We expect that our total future research and development costs will continue to align with our two core value drivers: (i) Active Immunotherapies being developed for the treatment and prevention of Alzheimer’s disease (AD) and Parkinson’s disease (PD); and (ii) Intracellular targeting with brain penetrant small molecule programs targeting intracellular pathologies.
Removed
The Company recognized this milestone payment as revenue because we deemed it highly probable that this milestone would be obtained and would not be subject to reversal in the future.
Added
Our collaboration agreements have different agreements to share costs for the development of our product candidates. We have completed our co-development costs with Janssen for the Phase 1b/2a studies for our active immunotherapy, ACI-35.030 and JACI-35.054.
Removed
LMI may terminate the LCA at any time by providing 3 months’ notice to us.
Added
For the year ended December 31, 2025: Discovery and preclinical expenses decreased by CHF 1.6 million, primarily due to: ● reduced activities in early-stage programs such as our anti TDP-43 antibody and PET tracer programs, whereby the pre-clinical development activities were completed in prior periods, and reduced research activities on ACI-24.060.
Removed
The structure of the collaboration agreement is as follows: ● A right-of-use license. ● Clinical milestone payments : payable upon the commencement of the Phase 1, 2 and 3 studies for generation of data intended to support a regulatory submission in the U.S. or the EU.
Added
These changes were offset by higher costs associated with our NLRP3 inhibitor and Morphomer Tau programs as they advance towards clinical development.
Removed
We would be entitled to further clinical milestone payments for the commencement of a Phase 2 and 3 study for a second indication. 125 Table of Contents ● Regulatory milestone payments : payable upon acceptance of Regulatory filing (NDA) and Regulatory approval for Commercialization in the U.S. or the EU. ● Commercialization milestones : tied to specific annual net sales amounts. ● Royalties: payable on sales, with royalty rates differing based on the level of annual sales.

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Selected Financial Data — reserved (removed by SEC in 2021)

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Biggest changeThe term of each of our directors is 1 year and, accordingly, will expire at our 2025 annual shareholder meeting to be held in June 2025. ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ Initial year of Name ​ Position ​ Age ​ appointment Executive Officers ​ ​ ​ ​ ​ ​ Andrea Pfeifer, Ph.D. ​ Chief Executive Officer and Director ​ 67 ​ 2003 Anke Post, M.D., Ph.D. ​ Chief Medical Officer ​ 59 ​ 2024 Christopher Roberts ​ Chief Financial Officer ​ 36 ​ 2019 Piergiorgio Donati ​ Chief Technical Operations Officer ​ 54 ​ 2018 Howard Donovan ​ Chief Human Resources Officer ​ 50 ​ 2022 ​ ​ ​ ​ ​ ​ ​ Other Key Employees ​ ​ ​ ​ ​ ​ Mark Danton EVP Artificial Intelligence and Information Systems 61 2019 Günther Staffler, Ph.D. ​ SVP Immunotherapy ​ 56 ​ 2021 Julien Rongère, Ph.D.
Biggest changeThe term of each of our directors is 1 year and, accordingly, will expire at our 2026 annual shareholder meeting to be held in June 2026. ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ Initial year of Name ​ Position ​ Age ​ appointment Executive Officers ​ ​ ​ ​ ​ ​ Andrea Pfeifer, Ph.D. ​ Chief Executive Officer and Director ​ 68 ​ 2003 Christopher Roberts ​ Chief Financial Officer ​ 37 ​ 2019 Piergiorgio Donati ​ Chief Technical Operations Officer ​ 55 ​ 2018 ​ ​ ​ ​ ​ ​ ​ Other Key Employees ​ ​ ​ ​ ​ ​ Mark Danton EVP Artificial Intelligence and Information Systems 62 2019 Günther Staffler, Ph.D. ​ EVP Development 1 ​ 57 ​ 2021 Julien Rongère, Ph.D.
The audit and finance committee has the responsibility to, among other things: ● review and assess the qualifications, independence, performance and effectiveness of the independent auditor; 149 Table of Contents ● review the scope of the prospective audit by the independent auditor, the estimated fees, and any other matters pertaining to the audit; ● approve any audit and non-audit services proposed to be provided by the independent auditor to ensure independent auditor independence; ● review and assess the independent auditor’s report and management letters and take notice of all comments of the independent auditor on accounting procedures and systems of control, and review the independent auditor’s reports with management; ● be responsible for the resolution of disagreements between the management and the independent auditor; ● review and evaluate the lead audit partner of the independent audit team and confirm and evaluate their rotation; ● review and discuss all (i) consolidated financial statements, (ii) reports intended for publication and (iii) any other financial statements intended for publication to consider significant financial reporting issues and judgments made in connection with the preparation of our consolidated financial statements, including any significant changes in our selection or application of accounting principles; ● approve the quarterly condensed consolidated financial statements; ● review with the management, personnel responsible for the design and implementation of the internal audit function, and the independent auditor in separate meetings any analysis or other written communication prepared by the management and/or the independent auditor setting forth significant financial reporting issues and judgments made in connection with the preparation of the consolidated financial statements, including critical accounting policies, the effect of regulatory and accounting initiatives, and off-balance sheet transactions and structures on our consolidated financial statements; ● review in cooperation with the independent auditor and the management whether the accounting principles applied are appropriate in view of our size and complexity; ● periodically review our policies and procedures for risk management and assess the effectiveness thereof, including discussing with management our major financial risk exposures and the steps that have been taken to monitor and control such exposure; ● discuss with management and external advisors any legal matters that may have a material impact on our consolidated financial statements and any material reports or inquiries from regulatory or governmental agencies that could materially impact our contingent liabilities and risks; ● review our disclosure controls and procedures and internal control over financial reporting, including significant deficiencies and material weaknesses in the design or operation of internal controls over financial reporting; ● establish procedures for the receipt, retention and treatment of complaints received regarding accounting, internal accounting controls or auditing matters, and the confidential, anonymous submission by employees of concerns regarding questionable accounting or auditing matters; and ● review and approve or ratify any related-person transaction in accordance with our related-person transaction policy.
The audit and finance committee has the responsibility to, among other things: ● review and assess the qualifications, independence, performance and effectiveness of the independent auditor; ● review the scope of the prospective audit by the independent auditor, the estimated fees, and any other matters pertaining to the audit; ● approve any audit and non-audit services proposed to be provided by the independent auditor to ensure independent auditor independence; ● review and assess the independent auditor’s report and management letters and take notice of all comments of the independent auditor on accounting procedures and systems of control, and review the independent auditor’s reports with management; ● be responsible for the resolution of disagreements between the management and the independent auditor; ● review and evaluate the lead audit partner of the independent audit team and confirm and evaluate their rotation; ● review and discuss all (i) consolidated financial statements, (ii) reports intended for publication and (iii) any other financial statements intended for publication to consider significant financial reporting issues and judgments made in connection with the preparation of our consolidated financial statements, including any significant changes in our selection or application of accounting principles; ● approve the quarterly condensed consolidated financial statements; ● review with the management, personnel responsible for the design and implementation of the internal audit function, and the independent auditor in separate meetings any analysis or other written communication prepared by the management and/or the independent auditor setting forth significant financial reporting issues and judgments made in connection with the preparation of the consolidated financial statements, including critical accounting policies, the effect of regulatory and accounting initiatives, and off-balance sheet transactions and structures on our consolidated financial statements; ● review in cooperation with the independent auditor and the management whether the accounting principles applied are appropriate in view of our size and complexity; ● periodically review our policies and procedures for risk management and assess the effectiveness thereof, including discussing with management our major financial risk exposures and the steps that have been taken to monitor and control such exposure; ● discuss with management and external advisors any legal matters that may have a material impact on our consolidated financial statements and any material reports or inquiries from regulatory or governmental agencies that could materially impact our contingent liabilities and risks; ● review our disclosure controls and procedures and internal control over financial reporting, including significant deficiencies and material weaknesses in the design or operation of internal controls over financial reporting; 135 Table of Contents ● establish procedures for the receipt, retention and treatment of complaints received regarding accounting, internal accounting controls or auditing matters, and the confidential, anonymous submission by employees of concerns regarding questionable accounting or auditing matters; and ● review and approve or ratify any related-person transaction in accordance with our related-person transaction policy.
Olivier Sol spent his over 20 year career as a Medical Expert in several therapeutic areas with a strong focus on central nervous system diseases, within pharmaceutical companies as Janssen, UCB-Pharma, GlaxoSmithKline and Sanofi. He contributed to the clinical development of currently marketed drugs in epilepsy (topiramate and levetiracetam) and galantamine in Alzheimer’s disease.
Olivier Sol spent his over 20 year career as a Medical Expert in several therapeutic areas with a strong focus on central nervous system diseases, within pharmaceutical companies as Janssen, UCB-Pharma, GlaxoSmithKline and 130 Table of Contents Sanofi. He contributed to the clinical development of currently marketed drugs in epilepsy (topiramate and levetiracetam) and galantamine in Alzheimer’s disease.
For an overview of our corporate governance principles, see “Item 16G. Corporate governance.” Board meetings Our Board of Directors met in accordance with their respective mandate both physically, by video-conference and telephonically throughout 2024.
For an overview of our corporate governance principles, see “Item 16G. Corporate governance.” Board meetings Our Board of Directors met in accordance with their respective mandate both physically, by video-conference and telephonically throughout 2025.
ITEM 6. DIRECTORS, SENIOR MANAGEMENT AND EMPLOYEES A. Directors and senior management Executive Officers, other key employees and board of directors The following table presents information about our executive officers, other key employees, and directors and director nominees, including their ages, as of March 1, 2025.
ITEM 6. DIRECTORS, SENIOR MANAGEMENT AND EMPLOYEES A. Directors and senior management Executive Officers, other key employees and board of directors The following table presents information about our executive officers, other key employees, and directors and director nominees, including their ages, as of March 1, 2026.
Prior to this she was a Visiting Fellow at the Human Carcinogenesis Branch of The National Institute of Health, Bethesda, USA. She currently serves as the Chair of Investment Fund BioMedInvest, 142 Table of Contents Basel and AB2 Bio SA, Lausanne. Dr. Pfeifer is a Non-Executive Member of the Board of Directors of E.M.S.
Prior to this she was a Visiting Fellow at the Human Carcinogenesis Branch of The National Institute of Health, Bethesda, USA. She currently serves as the Chair of Investment Fund BioMedInvest, Basel and AB2 Bio SA, Lausanne. Dr. Pfeifer is a Non-Executive Member of the Board of Directors of E.M.S.
The audit and finance committee will meet as often as it determines is appropriate to carry out its responsibilities, but in any event will meet at least four times per year. 150 Table of Contents Compensation, nomination and corporate governance committee The compensation, nomination and corporate governance committee, consists of Monika Bütler (Chair), Douglas Williams (Member) and Roy Twyman (Member).
The audit and finance committee will meet as often as it determines is appropriate to carry out its responsibilities, but in any event will meet at least four times per year. Compensation, nomination and corporate governance committee The compensation, nomination and corporate governance committee, consists of Monika Bütler (Chair), Douglas Williams (Member) and Roy Twyman (Member).
We incorporate by reference into this Annual Report the information contained in the section “Directors and Executive Management Compensation Report” under “Item 2. C—2024 and 2023 Board Compensation” and “Item 3. C—2024 and 2023 Executive Compensation” of Exhibit 99.2 to our report on Form 6-K filed with the SEC on March 13, 2025.
We incorporate by reference into this Annual Report the information contained in the section “Directors and Executive Management Compensation Report” under “Item 2. C—2025 and 2024 Board Compensation” and “Item 3. C—2025 and 2024 Executive Compensation” of Exhibit 99.4 to our report on Form 6-K filed with the SEC on March 13, 2026.
We are subject to the Swiss Executive Compensation (Say on Pay) Rule as enforced in the Code of Obligations. In addition, this committee will also be responsible for director and board committee nominations as well as reviewing and amending, if required, our corporate governance framework and guidelines. D.
We are subject to the Swiss Executive Compensation (Say on Pay) Rule as enforced in the Code of Obligations. In addition, this committee will also be responsible for director and board committee nominations as well as reviewing and amending, if required, our corporate governance framework and guidelines. 136 Table of Contents D.
Restricted share units granted to executive officers vest over a 1 year or 3 year period with vesting to occur quarterly or semi-annually. Please see “Note 18. Share-based compensation” for further detail. 148 Table of Contents C. Board practices Composition of board of directors Our board of directors is composed of seven directors.
Restricted share units granted to executive officers vest over a 1 year or 3 year period with vesting to occur quarterly or semi-annually. Please see “Note 18. Share-based compensation” for further detail. C. Board practices Composition of board of directors Our board of directors is composed of seven directors.
Our board of directors has determined that Monika Bütler, Monica Shaw and Douglas Williams satisfy the “independence” requirements set forth in Rule 10A-3 under the Exchange Act. The audit and finance committee is governed by a charter that complies with Nasdaq rules.
Our board of directors has 134 Table of Contents determined that Monika Bütler, Monica Shaw and Douglas Williams satisfy the “independence” requirements set forth in Rule 10A-3 under the Exchange Act. The audit and finance committee is governed by a charter that complies with Nasdaq rules.
The expiry dates for each plan are as follows: Plan C1: 10 years Amendment . Our board of directors has the authority to amend each of the Prior Plans. 147 Table of Contents 2016 SOIP At the November 15, 2016 AGM of the Company, our board of directors approved the 2016 SOIP (as amended and restated the “2016 SOIP”).
The expiry dates for each plan are as follows: Plan C1: 10 years Amendment . Our board of directors has the authority to amend each of the Prior Plans. 2016 SOIP At the November 15, 2016 AGM of the Company, our board of directors approved the 2016 SOIP (as amended and restated the “2016 SOIP”).
Under Plan C1, options were granted to our directors, employees, advisors and agents. Options exercise price . The exercise price of all options issued under the Prior Plan is CHF 0.15. Vesting period . Under Plan C1, the options vesting period was 4 years with 25% of the options vesting each year. Expiration period.
Under Plan C1, options were granted to our directors, employees, advisors and agents. 132 Table of Contents Options exercise price . The exercise price of all options issued under the Prior Plan is CHF 0.15. Vesting period . Under Plan C1, the options vesting period was 4 years with 25% of the options vesting each year. Expiration period.
Under her leadership, multiple transformative partnerships have been established with leading pharmaceutical companies, yielding a potential value of up to CHF 3.3 billion plus additional royalties. She has a 30+ years track record in senior R&D and business leadership roles in the life science industry.
Under her leadership, multiple transformative partnerships have been established with leading pharmaceutical 128 Table of Contents companies, yielding a potential value of up to CHF 4.3 billion plus additional royalties. She has a 30+ years track record in senior R&D and business leadership roles in the life science industry.
Each director is elected for a 1-year renewable term until the next Annual General Meeting (AGM). The current members of our board of directors were appointed at the AGM held on June 20, 2024 to serve until the 2025 AGM to be held in June 2025.
Each director is elected for a 1-year renewable term until the next Annual General Meeting (AGM). The current members of our board of directors were appointed at the AGM held on June 19, 2025 to serve until the 2026 AGM to be held in June 2026.
The amount set aside or accrued by us to provide pension, retirement or similar benefits to members of our board of directors and executive officers amounted to a total of CHF 0.5 million in the year ended December 31, 2024.
The amount set aside or accrued by us to provide pension, retirement or similar benefits to members of our board of directors and executive officers amounted to a total of CHF 0.4 million in the year ended December 31, 2025.
Olivier Sol, M.D., VP Head of Clinical Development : Prior to joining AC Immune, Olivier Sol was Clinical Director of Exonhit (Paris) and thereafter Medical & Regulatory Affairs Director for Diaxonhit, where he was 144 Table of Contents responsible for the development and medical validation of in vitro diagnostic products in cancer, infectious diseases and Alzheimer’s disease.
Olivier Sol, M.D., VP, Clinical Safety Officer : Prior to joining AC Immune, Olivier Sol was Clinical Director of Exonhit (Paris) and thereafter Medical & Regulatory Affairs Director for Diaxonhit, where he was responsible for the development and medical validation of in vitro diagnostic products in cancer, infectious diseases and Alzheimer’s disease.
As of December 31, 2024, the maximum number of shares available for issuance under the 2016 SOIP is 4,592,210 common shares. The shares available for issuance under the 2016 SOIP were initially registered with the SEC on a Form S-8 on March 8, 2017, and additional shares were registered on a Form S-8 on August 5, 2019.
As of December 31, 2025, the maximum number of shares available for issuance under the 2016 SOIP is 4,502,867 common shares. The shares available for issuance under the 2016 SOIP were initially registered with the SEC on a Form S-8 on March 8, 2017, and additional shares were registered on a Form S-8 on August 5, 2019.
As of December 31, 2023 and 2022 we had 161 and 156 employees, respectively. We have never had a work stoppage, and none of our employees is represented by a labor organization or under any collective-bargaining arrangements. We consider our employee relations to be good. 151 Table of Contents E. Share ownership See “Item 7. Major shareholders and related-party transactions—A.
As of December 31, 2024 and 2023 we had 172 and 161 employees, respectively. We have never had a work stoppage, and none of our employees is represented by a labor organization or under any collective-bargaining arrangements. We consider our employee relations to be good. E. Share ownership See “Item 7. Major shareholders and related-party transactions—A. Major shareholders.” F.
The expiration date for these options granted in 2024 is 2034. The Company also granted to our directors and executive officers a total of 557,934 restricted share units in 2024. Restricted share units granted to directors vest over a 1 year period with vesting to occur annually, depending on the nature of the award.
The expiration date for these options granted in 2025 is 2035. The Company also granted to our directors and executive officers a total of 900,516 restricted share units in 2025. Restricted share units granted to directors vest over a 1 year period with vesting to occur annually, depending on the nature of the award.
Staffler joined AC Immune from Affiris, where he held increasingly senior roles and was most recently Chief Technical Officer. He previously worked at a number of biotech companies in Vienna including Biovertis and Intercell (now Valneva). Dr. Staffler holds a PhD in Biochemistry with focus on Immunology from the Medical University of Vienna.
Staffler joined AC Immune from Affiris, where he held increasingly senior roles and was most recently Chief Technical Officer. He previously worked at a number of biotech companies in Vienna including Biovertis and Intercell (now Valneva). Dr.
Equity compensation For the fiscal year ended December 31, 2024, the Company has granted our directors and executive officers, in the aggregate, options for the right to acquire 406,680 shares at an exercise price ranging from USD 3.39 to USD 4.23 per share, which vest either over a 1 year or 3 year period with vesting to occur quarterly or annually depending on the nature of the award.
Equity compensation For the fiscal year ended December 31, 2025, the Company has granted our directors and executive officers, in the aggregate, options for the right to acquire 708,021 shares at an exercise price ranging from USD 1.84 to USD 2.91 per 133 Table of Contents share, which vest either over a 1 year or 3 year period with vesting to occur quarterly or annually depending on the nature of the award.
She joined as a research scientist and has since been Team Leader and Associate Vice President and Global Project Leader, playing key roles in development of small molecules targeting Tau and a-syn, as well as AC Immune’s a-syn PET tracer program, which delivered the first tracer capable of detecting a-syn pathology in patients. Dr.
She joined as a research scientist and has since been Team Leader, Global Project Leader, and now Vice President, playing key roles in development of small molecules targeting Tau and a-syn, as well as AC Immune’s a-syn PET tracer program. Dr.
Major shareholders.” F. Disclosure of a Registrant’s Action to Recover Erroneously Awarded Compensation Not applicable.
Disclosure of a Registrant’s Action to Recover Erroneously Awarded Compensation Not applicable.
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. He has published more than 500 manuscripts and is the recipient of numerous honors and prizes.
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.
Director 46 2021 ​ The current business addresses for our executive officers, other key employees, directors and director nominee is AC Immune SA, EPFL Innovation Park, Building B, 1015 Lausanne, Switzerland.
Director 72 2020 Renée Aguiar-Lucander Director 63 2025 ​ The current business addresses for our executive officers, other key employees, directors and director nominee is AC Immune SA, EPFL Innovation Park, Building B, 1015 Lausanne, Switzerland.
SVP Regulatory Affairs and Quality Assurance 47 2017 Gary Waanders, Ph.D. ​ SVP Investor Relations and Corporate Communications ​ 61 ​ 2021 Matthias Maurer, Ph.D. SVP General Counsel 43 2024 Bojana Portmann, Ph.D. VP IP and Business Development 45 2011 Olivier Sol, M.D. VP Head of Clinical Development 58 2016 Francesca Capotosti, Ph.D.
SVP Regulatory Affairs and Quality Assurance 48 2017 Gary Waanders, Ph.D. ​ SVP Investor Relations and Corporate Communications ​ 62 ​ 2021 Matthias Maurer, Ph.D. SVP General Counsel 44 2024 Bojana Portmann, Ph.D. VP IP and Business Development 46 2011 Olivier Sol, M.D. VP Clinical Safety Officer 59 2016 Francesca Capotosti, Ph.D.
Employees As of December 31, 2024, we employed 172 employees, 39 of whom were part-time employees. All of our employees are based in Switzerland. 78 of our employees hold Ph.D. degrees and 64 hold M.Sc. degrees. Our 172 employees are from 27 countries. The average number of employees (calculated on full-time equivalents) in 2024 was 147.2.
Employees As of December 31, 2025, we employed 122 employees, 32 of whom were part-time employees. All of our employees are based in Switzerland. 62 of our employees hold Ph.D. degrees and 45 hold M.Sc. degrees. Our 122 employees are from 20 countries. The average number of employees (calculated on full-time equivalents) in 2025 was 147.9.
Other key employees Mark Danton, EVP Artificial Intelligence and Information Systems : Mark Danton is a globally recognized and experienced executive in Information Systems/Information Technology (IS/IT) with extensive experience in developing, launching and managing business-relevant IS, cybersecurity and digital technology solutions and services.
Piergiorgio Donati holds a degree in Analytical Chemistry from the Technical Institute G.L. Bernini. Other key employees Mark Danton, EVP Artificial Intelligence and Information Systems : Mark Danton is a globally recognized and experienced executive in Information Systems/Information Technology (IS/IT) with extensive experience in developing, launching and managing business-relevant IS, cybersecurity and digital technology solutions and services.
As of December 31, 2024, there were a total of 4,097,932 shares underlying options that were exercisable and 5,010,827 shares underlying outstanding options and 822,740 shares underlying outstanding restricted share units issued from both our Prior Plans and the 2016 SOIP. Plan Administration .
As of December 31, 2025, there were a total of 4,815,928 shares underlying options that were exercisable and 5,518,564 shares underlying outstanding options and 763,816 shares underlying outstanding restricted share units issued from both our Prior Plans and the 2016 SOIP. Plan Administration .
Prior to joining AC Immune, he served as IS/IT Global Manager at Nestlé, driving excellence in security, risk and compliance at all locations within the multinational organization, and held a number of global roles at BT Global Services and in Dimension Data PLC. 143 Table of Contents Mark Danton holds an Executive MBA from the Business School Lausanne, graduating cum laude and as the Executive MBA Student of the Year.
Prior to joining AC Immune, he served as IS/IT Global Manager at Nestlé, driving excellence in security, risk and compliance at all locations within the multinational organization, and held a number of global roles at BT Global Services and in Dimension Data PLC.
He holds a Doctorate in Economics from Vienna University, a Master’s degree in Business Administration from Harvard University, and a degree in Psychology. Roy Twyman, M.D., Director : Roy Twyman is a Neurologist and is founder and current CEO of Amron Neuroscience, LLC, a private consulting company focused on neuroscience drug development. Prior to this, Dr.
Gallen, a Doctorate Honoris Causa from the University of Lucerne, and a Diploma in Mathematics/Physics from the University of Zurich. Roy Twyman, M.D., Director : Roy Twyman is a Neurologist and is founder and current CEO of Amron Neuroscience, LLC, a private consulting company focused on neuroscience drug development. Prior to this, Dr.
Compensation Compensation of directors and executive officers For the year ended December 31, 2024, the aggregate compensation accrued or paid to the members of our board of directors and our executive officers for services in all capacities was CHF 8.5 million. 146 Table of Contents During the year ended December 31, 2024, the total fair value of equity awards granted to directors and executive officers was CHF 3.6 million.
Compensation Compensation of directors and executive officers For the year ended December 31, 2025, the aggregate compensation accrued or paid to the members of our board of directors and our executive officers for services in all capacities was CHF 7.0 million.
She is responsible for AC Immune’s discovery and preclinical pipeline with a major focus on small-molecular weight compounds as therapeutic and diagnostic agents.
She served in various roles within the Company’s R&D leadership team prior to her promotion to VP Research in 2025. She is responsible for AC Immune’s discovery and preclinical pipeline with a major focus on small-molecular weight compounds as therapeutic and diagnostic agents.
She completed her residency and fellowship training in Psychiatry, Psychotherapy and Neurology at the Max Planck Institute of Psychiatry in Munich and received her Habilitation from the Ludwig Maximilian University in Munich. Christopher Roberts, Chief Financial Officer: Christopher Roberts joined AC Immune in 2019 serving in various roles within the Company’s finance leadership team prior to his promotion in 2022.
She received her Habilitation from the University of Lausanne, Switzerland and is an Honorary Professor at the Ecole Polytechnique Fédérale de Lausanne (EPFL). Christopher Roberts, Chief Financial Officer: Christopher Roberts joined AC Immune in 2019 serving in various roles within the Company’s finance leadership team prior to his promotion in 2022.
He has also gained significant experience in the field of biological biomarkers. Olivier Sol holds an M.D. from the Paris-Sud University (Paris-Saclay) with a specialization in Medical Biology. Francesca Capotosti, Ph.D., VP Research : Francesca Capotosti joined AC Immune in 2013 and has established significant expertise in the development of innovative diagnostics and therapeutic approaches to address neurodegenerative diseases.
Staffler holds a PhD in Biochemistry with focus on Immunology from the Medical University of Vienna. 129 Table of Contents Francesca Capotosti, Ph.D., VP Research : Francesca Capotosti joined AC Immune in 2013 and has established significant expertise in the development of innovative diagnostics and therapeutic approaches to address neurodegenerative diseases.
VP Research 44 2013 ​ ​ ​ ​ ​ ​ ​ Non-Executive Directors ​ ​ ​ ​ ​ ​ Douglas Williams, Ph.D. Chair and Director 66 2018 Monika Bütler, Ph.D. Vice Chair and Director 63 2021 Werner Lanthaler, Ph.D. Director 56 2018 Roy Twyman, M.D. Director 68 2019 Carl June, M.D. Director 71 2020 Monica Shaw, M.D.
VP Research 45 2013 ​ ​ ​ ​ ​ ​ ​ Non-Executive Directors ​ ​ ​ ​ ​ ​ Martin Zuegel, M.D. Chair and Director 63 2025 Monika Bütler, Ph.D. Vice Chair and Director 64 2021 Roy Twyman, M.D. Director 69 2019 Carl June, M.D.
Günther Staffler, Ph.D., SVP Immunotherapy : Günther Staffler joined AC Immune in 2021, bringing more than 25 years’ experience in immunology and biochemical research and establishing and managing drug development programs.
Mark Danton holds an Executive MBA from the Business School Lausanne, graduating cum laude and as the Executive MBA Student of the Year. Günther Staffler, Ph.D., EVP Development : Günther Staffler joined AC Immune in 2021, bringing more than 25 years’ experience in immunology and biochemical research and establishing and managing drug development programs.
Monica Shaw holds an M.D. from the University of Oxford Medical School and is a Member of the Royal College of Physicians. Family Relationships None of our directors or executive officers has a family relationship as defined in Item 401 of Regulation S-K. B.
Family Relationships None of our directors or executive officers has a family relationship as defined in Item 401 of Regulation S-K. B.
Capotosti completed postdoctoral studies at the École Polytechnique Fédérale de Lausanne (EPFL), and obtained a Ph.D. in Life Sciences from the University of Lausanne in 2010. Non-Executive Directors Douglas Williams, Ph.D., Chair and Director: Douglas E. Williams is currently part-time Head of R&D at Manifold Bio and Kelonia Therapeutics as well as senior executive advisor at TriArm Therapeutics.
Capotosti completed postdoctoral studies at the École Polytechnique Fédérale de Lausanne (EPFL), and obtained a Ph.D. in Life Sciences from the University of Lausanne in 2010.
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She received her Habilitation from the University of Lausanne, Switzerland and is an Honorary Professor at the Ecole Polytechnique Fédérale de Lausanne (EPFL). Anke Post, M.D., Ph.D., Chief Medical Officer: Anke Post joined AC Immune in September 2024 as Chief Medical Officer, bringing in-depth academic and medical knowledge in neuroscience, psychiatry and neurology. Dr.
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He served in various roles within the Company’s R&D leadership team prior to his promotion to EVP Development in 2025.
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Post has more than 25 years of academic and pharmaceutical R&D experience in three major multinational pharmaceutical organizations as well as in biotech and medical device companies.
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He has also gained significant experience in the field of biological biomarkers. Olivier Sol holds an M.D. from the Paris-Sud University (Paris-Saclay) with a specialization in Medical Biology. Non-Executive Directors Martin Zügel, M.D., Chair and Director: Martin Zügel MD is an experienced executive with 30 years at executive and board level in multinational healthcare companies. Dr.
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She started her career at Novartis and subsequently Eli Lilly & Co., where she was responsible for a global medical group in early clinical development, and as Head of Translational Medicine in Neurology at Roche, and has held senior roles with Idorsia, UniQure and GeNeuro. Dr. Post studied medicine in Berlin, Vienna and Münster, earning her M.D. from the latter.
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Zügel is a board member at Grünenthal, an international company specializing in the neuropharmacology of pain control, where he also chairs the audit committee. In addition, he is currently chairman of the board of AMW GmbH and MESI Ltd. Previously, Dr.
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Piergiorgio Donati holds a degree in Analytical Chemistry from the Technical Institute G.L. Bernini. Howard Donovan, Chief Human Resources Officer: Howard Donovan joined AC Immune in 2022 and is an internationally experienced, commercially focused leader who has competencies in all aspects of employee services, well-being, benefit design, international mobility, talent management, operations and HR business partnering.
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Zügel served as chairman, director, executive or advisor with several biotech companies addressing a variety of target medical indications and has also acted as advisor to biotech/pharma investors. Earlier in his career, Dr. Zügel was CEO of Merz Pharma GmbH.
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He had been at the World Economic Forum since 2015, where he led People Services and was responsible for global reward, employee experience, people insights, strategic sourcing, new office launches, and business partnering with the Board of Directors across its locations in Switzerland, United States, China, Japan and India.
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During his tenure at Merz, he was instrumental in building Memantine to a blockbuster Alzheimer Drug worldwide in close collaboration with Forest Labs, Daiichi Sankyo and Lundbeck A/S. He established, with specialty Neurology and Aesthetics, two new global franchises at Merz. He was an executive board member of B.
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Howard previously worked as the in-house Global Head of Reward for Puma Energy and prior to that he held senior HR leadership roles with a strong reward focus with multinational companies, including SGS Group and Xerox Corporation.
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Braun Melsungen AG in charge of their global hospital supply business and held various roles at Roche in their pharmaceuticals and diagnostics division. Dr. Zügel holds a Doctorate in Medicine from the University of Tübingen, and a Master Degree in Molecular Biology from the University of Massachusetts at Amherst.
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He was most recently President of R&D at Sana Biotechnology, a cell therapy company. He was the Founding President, CEO and member of the Board of Directors of Codiak BioSciences from September 2015 to April 2023. He was previously Biogen’s Executive Vice President, Research and Development, serving in this role from January 2011 to July 2015.
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He has published more than 500 manuscripts and is the recipient of numerous honors and prizes. 131 Table of Contents Renée Aguiar-Lucander, Director: Renée Aguiar-Lucander is an experienced health-care executive with a strong background in company management, financing and business development.
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He joined Biogen from ZymoGenetics, where he was most recently CEO and member of the Board of Directors. ZymoGenetics was purchased for USD 985 million by Bristol Myers Squibb during Dr. Williams’ tenure.
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She has extensive Board experience across private and public enterprises in Europe and the US, and successfully raised over USD 325M through public listings in Europe and US, out-licensings and debt financings. She is CEO of Hansa Biopharma, a Swedish company listed on OMX Stockholm. Previously, she was CEO of Calliditas Therapeutics AB, a Swedish NASDAQ traded company.
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Previously, he held leadership positions within the biotechnology industry, including Chief Scientific Officer and Executive Vice President of Research and Development at Seattle Genetics, and Senior Vice President and Washington Site Leader at Amgen. Dr.
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Beginning in 2017, Ms. Aguiar-Lucander led that company’s development of a targeted release formulation of budesonide to full FDA approval in Dec 2023. Ms. Aguiar-Lucander grew Calliditas to a fully integrated life science company headquartered in Europe with a complete US commercial footprint.
Removed
Williams served in a series of scientific and senior leadership positions over a decade at Immunex, including Executive Vice President and Chief Technology Officer and a member of the Board of Directors.
Added
In Q3 2024, Calliditas was acquired by the Japanese Company Asahi Kasei for 1.1B USD and is now fully integrated into Asahi Kasei, with revenues in excess of USD 150 million and operational profitability at time of exit. Prior to joining Calliditas, Ms.
Removed
During his 30+ year career in the biotechnology industry he has played a role in the development of several novel drugs including Leukine, Enbrel, Adcetris, Tecfidera, Alprolix, Eloctate, and Spinraza.
Added
Aguiar-Lucander spent more than twenty years in US and European private and public direct investment, gaining experience with Omega Fund, 3i Group plc, and at several large US based investment banks. Ms. Aguiar-Lucander holds a BA in Accounting from the Stockholm School of Economics and Finance, and an MBA from INSEAD.
Removed
He has served on the board of more than a dozen biotechnology companies and is currently Chairman of the Boards of AC Immune and Climb Bio, and Member of the Board of Stablix and TriArm Therapeutics.
Added
During the year ended December 31, 2025, the total fair value of equity awards granted to directors and executive officers was CHF 3.1 million.
Removed
Gallen, a Doctorate Honoris Causa from the University of Lucerne, and a Diploma in Mathematics/Physics from the University of Zurich. Werner Lanthaler, Ph.D., Director: Werner Lanthaler is the managing director of W.Lan Holding GmbH, an advisory and investment firm.
Removed
Up to January 2024, he was the CEO of Evotec AG, a drug discovery alliance and development partnership company focused on rapidly progressing innovative product approaches with leading pharmaceutical and biotechnology companies, academics, patient advocacy groups and venture capitalists. Dr. Lanthaler focused the company on collaborating with biotech and pharma companies and academia, supporting biotech innovation.
Removed
He previously served as Chief Financial Officer at Intercell AG where he played a key role in many of that company’s major milestones. During his tenure, Intercell undertook an IPO and developed from a venture-backed biotechnology 145 Table of Contents company into a global vaccine player. Dr.
Removed
Lanthaler has also served as Director of the Federation of Austrian Industry, and from 1995 to 1998 was a Senior Management Consultant at McKinsey & Company. Dr. Lanthaler is a Non-Executive Member of the Board of Directors of arGEN-X and is a member of the Supervisory Board of Topas Therapeutics GmbH.
Removed
Monica Shaw, M.D., Director: Monica Shaw is a pharmaceutical industry expert who has held senior leadership positions and was involved in advancing more than 15 therapeutic products from first-in-human studies through regulatory approvals and commercialization across multiple geographies. She also played key business development roles in company acquisition and integration and co-development partnerships. Through her work, Dr.
Removed
Shaw gained extensive specialty experience in the fields of dermatology, immuno-inflammation, HIV, neurology, and oncology. Currently, Dr. Shaw is Senior Vice President, Commercial Head Cell Therapy at Bristol Myers Squibb. Prior to this she was CEO for Oncopeptides, a Swedish listed biotech company, and before that, Executive Vice President Head Region Europe, Canada, Australia, for Leo Pharma.
Removed
In addition, she has previously held broad leadership roles at other leading pharmaceutical companies, including as Vice President Commercial Head Asia Pacific region at GSK/ViiV Healthcare, and Medical Director and Chief Scientific Officer UK for Novartis, in addition to previous leadership positions at Norgine, Shire and Merck KGaA.

Item 7. Management's Discussion & Analysis

Management's Discussion & Analysis (MD&A) — revenue / margin commentary

9 edited+4 added−3 removed11 unchanged
Biggest changeIn these offerings, we issued and sold 10,000,000 common shares, including 1,108,695 sold to the underwriters pursuant to the underwriters’ over-allotment option. The percentage ownership held by certain shareholders decreased as a result of the issuance of the common shares sold by us in these offerings. In December 2023, we completed an offering of our common shares.
Biggest changeThe percentage ownership held by certain shareholders decreased as a result of the issuance of the common shares sold by us in these offerings. 139 Table of Contents In December 2023, we completed an offering of our common shares. In this offering, we issued and sold 14,300,000 common shares to the underwriters pursuant to the underwriters’ agreement.
Under such rules, beneficial ownership includes any common shares over which the individual has sole or shared voting power or investment power as well as any common shares that the individual has the right to acquire within 60 days of March 1, 2025 through the exercise of any option, warrant or other right.
Under such rules, beneficial ownership includes any common shares over which the individual has sole or shared voting power or investment power as well as any common shares that the individual has the right to acquire within 60 days of March 1, 2026 through the exercise of any option, warrant or other right.
Holders As of March 1, 2025, we had approximately 250 shareholders of record of our common shares. The actual number of stockholders is greater than this number of record holders and includes stockholders who are beneficial owners but whose shares are held in street name by brokers and other nominees.
Holders As of March 1, 2026, we had over 250 shareholders of record of our common shares. The actual number of stockholders is greater than this number of record holders and includes stockholders who are beneficial owners but whose shares are held in street name by brokers and other nominees.
Common shares that a person has the right to acquire within 60 days of March 1, 2025 are deemed outstanding for purposes of computing the percentage ownership of the person holding such rights, but are not deemed outstanding for purposes of computing the percentage ownership of any other person, except with respect to the percentage ownership of all executive officers and directors as a group.
Common shares that a person has the right to acquire within 60 days of March 1, 2026 are deemed outstanding for purposes of computing the percentage ownership of the person holding such rights, but are not deemed outstanding for purposes of computing the percentage ownership of any other person, except with respect to 137 Table of Contents the percentage ownership of all executive officers and directors as a group.
Except as otherwise indicated, and subject to applicable community property laws, the persons named in the table have sole voting and investment power with respect to all common shares held by that person. The percentage of outstanding common shares is computed on the basis of 100,410,377 common shares outstanding as of March 1, 2025.
Except as otherwise indicated, and subject to applicable community property laws, the persons named in the table have sole voting and investment power with respect to all common shares held by that person. The percentage of outstanding common shares is computed on the basis of 101,773,573 common shares outstanding as of March 1, 2026.
Unless otherwise indicated below, the address for each beneficial owner is AC Immune, EPFL Innovation Park, Building B, 1015 Lausanne, Switzerland. ​ 152 Table of Contents ​ ​ ​ ​ ​ ​ ​ Shares beneficially Shareholder ​ Number ​ owned (%) 5% Shareholders ​ Biotechnology Value Fund (BVF) Inc. 1 19,522,436 19.4 % dievini Hopp BioTech holding GmbH & Co KG 2 16,316,742 16.3 % Varuma AG 3 11,999,999 12.0 % Affiris AG 4 6,428,100 6.4 % Executive Officers and Directors ​ Andrea Pfeifer 5 4,344,077 4.3 % Anke Post 6 * * ​ Piergiorgio Donati 7 * * ​ Christopher Roberts 8 * * ​ Howard Donovan 9 ​ * * ​ Douglas Williams 10 * * ​ Monika Bütler 11 * * ​ Werner Lanthaler 12 * * ​ Roy Twyman 13 * * ​ Carl June 14 * * ​ Monica Shaw 15 * * ​ All executive officers and directors as a group (11 persons) 6,468,046 6.4 % * Indicates beneficial ownership of less than 1% of the total issued and outstanding common shares. 1 Based on information set forth in a Schedule 13G/A filed with the SEC by BVF on November 14, 2024, these shares consist of 19,522,436 shares held of record by BVF Inc.
Unless otherwise indicated below, the address for each beneficial owner is AC Immune, EPFL Innovation Park, Building B, 1015 Lausanne, Switzerland. ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ Shares beneficially Shareholder ​ Number ​ owned (%) 5% Shareholders ​ ​ ​ Biotechnology Value Fund (BVF) Inc. 1 19,822,436 19.5 % dievini Hopp BioTech holding GmbH & Co KG 2 16,316,742 16.0 % Varuma AG 3 11,999,999 11.8 % Affiris AG 4 6,428,100 6.3 % Executive Officers and Directors ​ ​ ​ Andrea Pfeifer 5 5,010,675 4.9 % Anke Post 6 * * ​ Piergiorgio Donati 7 * * ​ Christopher Roberts 8 * * ​ Howard Donovan 9 ​ * * ​ Martin Zügel 10 * * ​ Monika Bütler 11 * * ​ Renée Aguiar-Lucander 12 * * ​ Roy Twyman 13 * * ​ Carl June 14 * * ​ All executive officers and directors as a group (10 persons) 6,404,603 6.3 % * Indicates beneficial ownership of less than 1% of the total issued and outstanding common shares. 1 Based on information set forth in a Schedule 13F filed with the SEC by BVF on February 17, 2026, these shares consist of 19,822,436 shares held of record by BVF Inc.
Prior to our IPO in September 2016, our principal shareholders were dievini Hopp BioTech holding GmbH & Co KG and Varuma AG, which held shares representing 36.5% and 23.1%, respectively. As of March 1, 2025, dievini Hopp BioTech holding GmbH & Co KG and Varuma AG held 16.3% and 12.0% of our outstanding common shares, respectively.
Prior to our IPO in September 2016, our principal shareholders were dievini Hopp BioTech holding GmbH & Co KG and Varuma AG, which held shares representing 36.5% and 23.1%, respectively. In September 2016, we completed our IPO and listed our common shares on the Nasdaq Global Market.
In this offering, we issued and sold 14,300,000 common shares to the underwriters pursuant to the underwriters’ agreement. The percentage ownership held by certain shareholders decreased as a result of the issuance of the common shares sold by us in this offering. B. Related-party transactions None.
In the IPO, we issued and sold 6,900,000 common shares, including 900,000 common shares sold to the underwriters pursuant to the underwriters’ over-allotment option. While none of our existing shareholders sold common shares in the IPO, the percentage ownership held by certain shareholders decreased as a result of the issuance of the common shares sold by us in the IPO.
In the IPO, we issued and sold 6,900,000 common shares, including 900,000 common shares sold to the underwriters pursuant to the underwriters’ over-allotment option.
In July 2018, we completed three offerings of our common shares. In these offerings, we issued and sold 10,000,000 common shares, including 1,108,695 sold to the underwriters pursuant to the underwriters’ over-allotment option.
Removed
The address of Affiris AG is Karl-Farkas-Gasse 22, 1030 Vienna, Austria. 5 Consists of 2,956,067 of our common shares and options to purchase 1,388,010 of our common shares exercisable within 60 days of March 1, 2025. 153 Table of Contents 6 Consists of 9,804 of our common shares and options to purchase 18,830 of our common shares exercisable within 60 days of March 1, 2025. 7 Consists of 45,800 of our common shares and options to purchase 195,328 of our common shares exercisable within 60 days of March 1, 2025. 8 Consists of 38,048 of our common shares and options to purchase 74,485 of our common shares exercisable within 60 days of March 1, 2025. 9 Consists of 40,797 of our common shares and options to purchase 87,255 of our common shares exercisable within 60 days of March 1, 2025. 10 Consists of 58,008 of our common shares and options to purchase 129,458 of our common shares exercisable within 60 days of March 1, 2025. 11 Consists of 27,099 of our common shares and options to purchase 110,337 of our common shares exercisable within 60 days of March 1, 2025. 12 Consists of 140,003 of our common shares and options to purchase 107,701 of our common shares exercisable within 60 days of March 1, 2025. 13 Consists of 50,969 of our common shares and options to purchase 125,883 of our common shares exercisable within 60 days of March 1, 2025. 14 Consists of 25,969 of our common shares and options to purchase 104,688 of our common shares exercisable within 60 days of March 1, 2025. 15 Consists of 24,969 of our common shares and options to purchase 107,682 of our common shares exercisable within 60 days of March 1, 2025.
Added
The address of Affiris AG is Karl-Farkas-Gasse 22, 1030 Vienna, Austria. 138 Table of Contents 5 Consists of 3,433,541 of our common shares and options to purchase 1,577,134 of our common shares exercisable within 60 days of March 1, 2026. 6 Consists of 41,706 of our common shares and options to purchase 79,565 of our common shares exercisable within 60 days of March 1, 2026. 7 Consists of 74,244 of our common shares and options to purchase 261,534 of our common shares exercisable within 60 days of March 1, 2026. 8 Consists of 75,372 of our common shares and options to purchase 150,922 of our common shares exercisable within 60 days of March 1, 2026. 9 Consists of 64,517 of our common shares and options to purchase 134,078 of our common shares exercisable within 60 days of March 1, 2026. 10 New board member, holding no shares as of March 1, 2026.
Removed
BVF Inc. increased its holdings from 14.7% to 19.4% of our outstanding common shares in 2024. Affiris became major shareholder in 2021 and owns 6.4% of our outstanding common shares as of March 1, 2025. In September 2016, we completed our IPO and listed our common shares on the Nasdaq Global Market.
Added
No grants have been vested nor are expected to vest within 60 days of March 1, 2026 11 Consists of 35,386 of our common shares and options to purchase 125,438 of our common shares exercisable within 60 days of March 1, 2026. 12 New board member, holding no shares as of March 1, 2026.
Removed
While none of our existing shareholders sold common shares in the IPO, the percentage ownership held by certain shareholders decreased as a result of the issuance of the common shares sold by us in the IPO. 154 Table of Contents In July 2018, we completed three offerings of our common shares.
Added
No grants have been vested nor are expected to vest within 60 days of March 1, 2026 13 Consists of 33,704 of our common shares and options to purchase 139,977 of our common shares exercisable within 60 days of March 1, 2026. 14 Consists of 58,704 of our common shares and options to purchase 118,782 of our common shares exercisable within 60 days of March 1, 2026.
Added
The percentage ownership held by certain shareholders decreased as a result of the issuance of the common shares sold by us in this offering. As of March 1, 2026, BVF, Inc., dievini Hopp BioTech holding GmbH & Co KG, Varuma AG, and Affiris have not had significant changes in shareholdings compared to March 1, 2025. B. Related-party transactions None.

Other ACIU 10-K year-over-year comparisons