UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 6-K
REPORT OF FOREIGN PRIVATE ISSUER PURSUANT TO RULE 13a-16 OR 15d-16 UNDER THE SECURITIES EXCHANGE ACT OF 1934
For the month of August, 2024
Commission file number: 001-37891
AC IMMUNE SA
(Exact Name of Registrant as Specified in Its Charter)
EPFL Innovation Park
Building B
1015 Lausanne, Switzerland
(Address of Principal Executive Offices)
Indicate by check mark whether the registrant files or will file annual reports under cover of Form 20-F or Form 40-F.
Form 20-F ☒ Form 40-F ☐
This Report on Form 6-K (excluding Exhibit 99.3 hereto) shall be deemed to be incorporated by reference into the registration statements on Form F-3 (File Nos. 333-227016, 333-249655, 333-255576 and 333-277940) and Form S-8 (File Nos. 333-213865, 333-216539 and 333-233019) of AC Immune SA and to be a part thereof from the date on which this report is filed, to the extent not superseded by documents or reports subsequently filed or furnished.
SIGNATURE
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned, thereunto duly authorized.
AC IMMUNE SA | ||
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| By: | /s/ Andrea Pfeifer |
| | Name: Andrea Pfeifer |
| | Title: Chief Executive Officer |
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| By: | /s/ Christopher Roberts |
| | Name: Christopher Roberts |
| | Title: Chief Financial Officer |
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Date: August 6, 2024 | | |
EXHIBIT INDEX
Exhibit |
| Description |
3.1 | | |
10.1† | | |
99.1 | | |
99.2 | | Management’s Discussion and Analysis of Financial Condition and Results of Operations |
99.3 | |
† Registrant has omitted portions of the exhibit as permitted under Item 601(b)(10) of Regulation S-K.
EXECUTION VERSION
[***] Certain information in this document has been excluded pursuant to Regulation S-K, Item 601(b)(10). Such excluded information is not material and is the type that the registrant treats as private or confidential.
between
AC Immune SA
and
TAKEDA PHARMACEUTICALS, USA, INC.
Dated as of May 11, 2024
TABLE OF CONTENTS
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Schedules
Schedule 1.18Amyloid Precursor Protein Sequences
Schedule 1.39CMC Development Plan
Schedule 1.40CMC Readiness Elements
Schedule 1.58Data Package
Schedule 1.68Development Plan
Schedule 1.138Other Licensed Patents
Schedule 1.148Phase 3 Process Elements
Schedule 1.157Product Patents
[***][***]
Schedule 3.3.3Clean Team Agreement
Schedule 3.4Permitted Subcontractors
Schedule 3.5.1FDA Question
Schedule 6.1.2 Pre-Option Effective Date Materials
Schedule 6.1.4Supply Terms
Schedule 10.7Press Release
Schedule 10.10Standard Contractual Clauses
Schedule 11.2.2Existing Agreements
Schedule 11.2.8Existing Inventions Funded by Governmental Authority
Schedule 11.2.14Existing Third Party Obligations of ACI
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OPTION AND LICENSE AGREEMENT
This Option and License Agreement (the “Agreement”) is made and entered into as of May 11, 2024 (the “Effective Date”) by and between AC Immune SA, a Swiss company (“ACI”) and Takeda Pharmaceuticals, USA, Inc., a corporation organized under the laws of the State of Delaware (“Takeda”). ACI and Takeda are sometimes referred to herein individually as a “Party” and collectively as the “Parties”.
Recitals
WHEREAS, ACI owns and controls certain intellectual property rights with respect to the Licensed Compounds (as defined herein) and Licensed Products (as defined herein) in the Territory (as defined herein); and
WHEREAS, ACI wishes to grant to Takeda, and Takeda wishes to take, an exclusive option to obtain an exclusive license under such intellectual property rights to develop, manufacture and commercialize Licensed Compounds and Licensed Products in the Territory, in each case, in accordance with the terms and conditions set forth below.
NOW, THEREFORE, in consideration of the premises and the mutual promises and conditions set forth herein and other good and valuable consideration, the receipt and sufficiency of which are hereby acknowledged, the Parties, intending to be legally bound, do hereby agree as follows:
Unless otherwise specifically provided herein, the following terms shall have the following meanings:
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Notwithstanding the foregoing, amounts received or invoiced by Takeda or its Affiliates or its or their Sublicensees for the sale of such Licensed Product among Takeda or its Affiliates or its or their Sublicensees for resale will not be included in the computation of Net Sales hereunder; [***] For clarity, a particular deduction may only be accounted for once in the calculation of Net Sales. [***]
For purposes of calculating Net Sales, all Net Sales shall be converted into Dollars in accordance with Section 8.9.
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provided that, in each case ((i) and (ii)), neither Party shall exercise its final decision-making authority in a manner that is reasonably likely to cause the other Party to violate Applicable Law.
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In participating in the JDT, and in exercising their rights under this Article 2, all representatives of both Parties shall consider reasonably and in good faith all input received from the other Party.
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POST-OPTION DEVELOPMENT, REGULATORY AND COMMERCIALIZATION ACTIVITIES
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[***]
For clarity, Development Milestone Event No. 2 shall not apply, and Development Milestone Payment No. 2 shall not be due, if the Option Effective Date occurs and Takeda assumes control of the Phase 1b/2 Trial in accordance with Section 7.2.2 prior to achievement of Development Milestone Event No. 2.
Each Development Milestone Payment in this Section 8.3 shall be payable only upon the first achievement of the corresponding Development Milestone Event and no amounts shall be due for subsequent or repeated achievements of such Development Milestone Event, whether for the same or a different Licensed Product. If Development Milestone Event No. 4 is achieved and Development Milestone Event No. 3 has not been previously paid to ACI, then such unpaid Development Milestone Event No. 3 will be deemed achieved and the corresponding Development Milestone Payment shall be payable in addition to and concurrently with Development Milestone Event No. 4. If Development Milestone Event No. 5, Development Milestone Event No. 6 or Development Milestone Event No. 7 is achieved and Development Milestone Event No. 3 or Development Milestone Event No. 4 has not been previously paid to ACI, then such unpaid Development Milestone Event No. 3 or Development Milestone Event No. 4, as applicable, will be deemed achieved and the corresponding Development Milestone Payment shall be payable in addition to and concurrently with Development Milestone Event No. 5, Development Milestone Event No. 6 or Development Milestone Event No. 7, as applicable. The maximum aggregate [***] for the full amount of the corresponding Development Milestone Payment, which amount shall be payable [***] after the receipt by Takeda of a valid invoice.
Each Commercial Milestone Payment in this Section 8.4 shall be payable only upon the first achievement of the corresponding Commercial Milestone Event and no amounts shall be due for subsequent or repeated achievements of such Commercial Milestone Event in any given or subsequent Fiscal Year, whether for the same or a different Licensed Product. The maximum aggregate amount payable by Takeda pursuant to this Section 8.4 is [***]
In the event that any of the Commercial Milestone Events set forth in this Section 8.4 occurs and any of the preceding Commercial Milestone Events set forth in this Section 8.4 have not occurred, then each such skipped Commercial Milestone Payment shall become due and payable concurrently with the Commercial Milestone Payment for the Commercial Milestone Event with respect to which payment is due.
Following the end of a Fiscal Year in which a given Commercial Milestone Event was achieved, Takeda will send ACI written notice that such Commercial Milestone Event is achieved under this
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Section 8.4, within [***] following the end of such Fiscal Year. Following receipt of such notice, ACI shall submit an invoice promptly, but no more than [***] after receipt of such notice, to Takeda for the full amount of the corresponding Commercial Milestone Payment, which amount shall be payable [***] after the receipt of a valid invoice.
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For the purposes of this Section 8.10, “ACI” and “Takeda” include any assignees under Section 14.3 of such respective Party.
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Specific aspects or details of Confidential Information shall not become exempt from the obligations set forth in this Article 10 merely because the Confidential Information is embraced by more general information included in the exceptions set forth in this Section 10.2. Further, any combination of Confidential Information shall not become exempt from the obligations herein merely because individual elements of such Confidential Information are included in the exceptions set forth in this Section 10.2, unless the combination and its principles fall within one or more of such exceptions.
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provided that, in each case, any update in a Data Package Updated Disclosure Schedule or a Bring Down Updated Disclosure Schedule (as applicable) shall not be deemed to amend or supplement the Initial Disclosure Schedule as it exists as of the Effective Date or Data Package Updated Disclosure Schedule as it exists as of the Data Package Bring Down Date or prior to such amendment for any purposes hereunder, including for the purposes of the indemnification provisions under Section 12.2 (and therefore shall not cure any prior failure to disclose). For all representations and warranties for which ACI does not provide an updated schedule pursuant to clause (a) of Section 11.3.1 or clause (x) of Section 11.3.2 (as applicable), or if ACI fails to provide any updated schedules or such statement in clause (b) of Section 11.3.1 or clause (y) Section 11.3.2 (as applicable) within the time periods set forth in each such Section, ACI shall be deemed to have made the representations and warranties in Section 11.2 to Takeda as of the Data Package Bring Down Date and the Option Effective Date (as applicable) without additional qualification. For the avoidance of doubt, an exception made by ACI in a Data Package Updated Disclosure Schedule or a Bring Down Updated Disclosure Schedule (as applicable) shall not cure a deficiency in the Initial Disclosure Schedule or Data Package Updated Disclosure Schedule (as applicable). ACI acknowledges and agrees that any disclosure made in a Data Package Updated Disclosure Schedule or a Bring Down Updated Disclosure Schedule (as applicable) cannot cure a breach of any covenant or obligation of ACI hereunder, including Section 11.5, and no disclosure made in a Data Package Updated Disclosure Schedule or a Bring Down Updated Disclosure Schedule (as applicable) that relates to or reflects any such breach by ACI shall be deemed to qualify any representation or warranty hereunder.
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All insurances maintained by a Party as required hereunder will be provided by a company having a financial rating of not less than A-Viii in the most current edition of Best’s Key Rating Guide. Upon request by a Party, each Party shall provide to the requesting Party evidence of its insurance coverage. Each Party will provide a minimum of [***] notice of any cancellation, with no replacement policy, to the other Party. The insurance policies shall be under an occurrence form, but if only a claims-made form is available to a Party, then such Party shall continue to maintain such insurance after the expiration or termination of this Agreement in its entirety for a period of [***] the foregoing, Takeda may self-insure in whole or in part the insurance requirements described above.
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It is understood that termination pursuant to this Section 13.2.1 shall be a remedy of last resort and may be invoked only in the case where the breach cannot be reasonably remedied by the payment of money damages.
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If this Agreement is terminated with respect to one (1) or more Licensed Products or one (1) or more countries but not in its entirety, then following such termination, the foregoing provisions of this Agreement set forth in Section 13.8.1 shall remain in effect with respect to the terminated Licensed Product(s) in the terminated country(ies) (to the extent they would survive and apply in the event this Agreement is terminated in its entirety or as otherwise necessary for any of Takeda and its Affiliates and its and their Sublicensees to exercise their rights for the other Licensed Products or other countries) and all provisions not surviving in accordance with the foregoing shall terminate upon termination of this Agreement and be of no further force and effect with respect to the terminated Licensed Product(s) for the terminated country(ies) (and for the avoidance of doubt all provisions of this Agreement shall remain in effect with respect to all non-terminated Licensed Products and non-terminated countries).
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provided that, in each case in which this Agreement is assigned in its entirety to an Affiliate or Third Party, the assigning Party shall provide written notice to the other Party within [***] such assignment. Any permitted successor of a Party or any permitted assignee of all of a Party’s rights under this Agreement that has also assumed all of such Party’s obligations hereunder in writing shall, upon any such succession or assignment and assumption, be deemed to be a party to this
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Agreement as though named herein in substitution for the assigning Party, whereupon the assigning Party shall cease to be a party to this Agreement and shall cease to have any rights or obligations under this Agreement; [***]
All validly assigned rights of a Party shall inure to the benefit of and be enforceable by, and all validly delegated obligations of such Party shall be binding on and be enforceable against, the permitted successors and assigns of such Party. Any attempted assignment or delegation in violation of this Section 14.3 shall be void and of no effect ab initio.
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If to Takeda, to:
Takeda Pharmaceuticals, USA, Inc.
95 Hayden Avenue
Lexington, MA 02421
Attention: Regional General Counsel
[***]
with a copy (which shall not constitute notice) to:
Takeda Pharmaceutical Company Limited
1-1 Doshomachi 4-chomeChuo-ku, Osaka
540-8645, Japan
Attention: Head of Center for External Innovation
[***]
If to ACI, to:
EPFL Innovation Park, Building B
CH-1015 Lausanne, Switzerland
[***]
[***]
with a copy (which shall not constitute notice) to:
AC Immune SA
EPFL Innovation Park, Building B
CH-1015 Lausanne, Switzerland
Attention: General Counsel, Legal Department
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[SIGNATURE PAGE FOLLOWS.]
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THIS AGREEMENT IS EXECUTED by the authorized representatives of the Parties as of the Effective Date.
TAKEDA PHARMACEUTICALS, USA, INC. | AC IMMUNE SA |
By: Name: Title: | By: Name: Title: |
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By: Name: Title: |
[Signature Page to Option and License Agreement]
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Schedule 10.7
Press Release
News Release
AC Immune and Takeda Sign Exclusive Option and License Agreement for Active Immunotherapy Targeting Amyloid Beta for Alzheimer’s Disease
OSAKA, Japan, CAMBRIDGE, Massachusetts, and LAUSANNE, Switzerland, May 13, 2024 – Takeda (TSE:4502/NYSE:TAK) and AC Immune SA (NASDAQ: ACIU) today announced an exclusive, worldwide option and license agreement for AC Immune’s active immunotherapies targeting toxic forms of amyloid beta (Abeta), including ACI-24.060 for the treatment of Alzheimer’s disease.
ACI-24.060 is an anti-Abeta active immunotherapy candidate designed to induce a robust antibody response against the toxic forms of Abeta believed to drive plaque formation and Alzheimer’s disease progression. By inducing plaque clearance and efficiently inhibiting plaque formation in the brain, ACI-24.060 has the potential to delay or slow Alzheimer’s disease progression. ACI-24.060 is being investigated in the ongoing ABATE randomized, double-blind, placebo-controlled Phase 1b/2 trial to assess the safety, tolerability, immunogenicity and pharmacodynamic effects of the investigational immunotherapy in subjects with prodromal Alzheimer’s disease and in adults with Down syndrome.
“As pioneers in the field of active immunotherapy, we are developing an innovative approach that could change the treatment paradigm for Alzheimer’s disease and address the multifaceted burden that patients and the broader community face. We believe the maximum impact of ACI-24.060 can best be realized by partnering with Takeda at this critical juncture in its development, which will help us move rapidly into Phase 3,” said Dr. Andrea Pfeifer, CEO of AC Immune. “This agreement allows us to leverage the developmental expertise, strategic vision and financial capacity of an accomplished organization that has demonstrated its ability to execute the type of comprehensive global program required for Phase 3 trials in Alzheimer’s disease while allowing us to focus on completing Phase 1b/2 development and accelerating our efforts to replicate this success with enhanced funding for our early-stage pipeline.”
AC Immune will be responsible for completing the ABATE trial. Following option exercise, Takeda would conduct and fund all further clinical development and be responsible for all global regulatory activities as well as worldwide commercialization.
“At Takeda, we are committed to tackling some of society’s most debilitating illnesses, including Alzheimer’s disease. We are excited to partner with AC Immune on this ground-breaking treatment
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approach, which leverages novel technology with the potential to offer patients a treatment with differentiated efficacy, safety and ease of administration,” said Sarah Sheikh, M.Sc., B.M., B.Ch, MRCP, Head, Neuroscience Therapeutic Area Unit and Head, Global Development at Takeda. “Combining AC Immune’s deep experience with active immunotherapy approaches with Takeda’s expertise in neuroscience drug development and commercialization, we have an incredible opportunity to deliver real impact to the Alzheimer’s community.”
Under the terms of the agreement, AC Immune will receive an upfront payment of $100 million and be eligible to receive an option exercise fee and additional potential development, commercial and sales-based milestones of up to approximately $2.1 billion if all related milestones are achieved over the course of the agreement. Upon commercialization, AC Immune will be entitled to receive tiered double-digit royalties on worldwide net sales.
Further details related to the agreement are available in the Form 6-K filed today by AC Immune with the U.S. Securities and Exchange Commission (SEC). The effectiveness of Takeda’s license following option exercise is subject to the termination or expiration of any applicable waiting periods under the Hart-Scott-Rodino Act.
Conference Call and Webcast Information
AC Immune management will host a conference call and webcast today at 8:30 a.m. ET to provide a brief overview of the agreement.
Monday, May 13 at 8:30 a.m. ET
Participants wishing to ask questions or to join the event via phone may call the following numbers 10 – 15 minutes before conference start:
United States | +1 (1) 631 570 56 13 |
Switzerland / Europe | +41 (0) 58 310 50 00 |
United Kingdom | +44 (0) 207 107 06 13 |
Other international numbers available | HERE |
Webcast:
https://event.choruscall.com/mediaframe/webcast.html?webcastid=YteAZhdg
Please note that there is a function to type in your questions via webcast.
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A live and archived webcast will also be accessible in the Investors section of the Company's website at https://www.acimmune.com/.
About ACI-24.060
This product is AC Immune’s anti-Abeta active immunotherapy candidate. The ABATE randomized, double-blind, placebo-controlled Phase 1b/2 trial of ACI-24.060 for treatment of Alzheimer’s disease (AD) continues fully blinded (NCT05462106). Enrolled patients are required to have a diagnosis of prodromal AD: MCI due to AD according to the National Institute on Aging Alzheimer’s Association (NIA-AA) criteria, and a PET scan at screening must be consistent with the presence of amyloid pathology. Patients will be randomized to one of several doses of ACI-24.060 or placebo. Following multiple data safety monitoring board (DSMB) reviews, no safety concerns have been raised to date, consistent with previous results. Immunogenicity of the immunotherapy is very encouraging with clear evidence of anti-Abeta antibody responses against toxic Abeta species observed in the blinded data. The six-month Abeta positron emission tomography (PET) imaging results are expected in Q2 2024, and the 12-month Abeta PET data are expected in Q4 2024.
About Takeda
Takeda is focused on creating better health for people and a brighter future for the world. We aim to discover and deliver life-transforming treatments in our core therapeutic and business areas, including gastrointestinal and inflammation, rare diseases, plasma-derived therapies, oncology, neuroscience and vaccines. Together with our partners, we aim to improve the patient experience and advance a new frontier of treatment options through our dynamic and diverse pipeline. As a leading values-based, R&D-driven biopharmaceutical company headquartered in Japan, we are guided by our commitment to patients, our people and the planet. Our employees in approximately 80 countries and regions are driven by our purpose and are grounded in the values that have defined us for more than two centuries. For more information, visit www.takeda.com.
About AC Immune SA
AC Immune SA is a clinical-stage biopharmaceutical company that aims to become a global leader in precision medicine for neurodegenerative diseases, including Alzheimer’s disease, Parkinson’s disease, and NeuroOrphan indications driven by misfolded proteins. The Company’s two clinically validated technology platforms, SupraAntigen® and Morphomer®, fuel its broad and diversified pipeline of first- and best-in-class assets, which currently features sixteen therapeutic and diagnostic programs, five of which are currently in Phase 2 clinical trials and one of which is in Phase 3. AC Immune has a strong track record of securing strategic partnerships with leading global pharmaceutical companies, resulting in substantial non-dilutive funding to advance its proprietary programs and >$4.5 billion in potential milestone payments.
SupraAntigen® is a registered trademark of AC Immune SA in the following territories: AU, EU, CH, GB, JP, RU, SG and USA. Morphomer® is a registered trademark of AC Immune SA in CN, CH, GB, JP, KR, NO and RU.
The information on our website and any other websites referenced herein is expressly not incorporated by reference into, and does not constitute a part of, this press release.
AC Immune Investor and Media Contacts:
SVP, Investor Relations & Corporate
Communications
Gary Waanders, Ph.D., MBA AC Immune
Phone: +41 21 345 91 91
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gary.waanders@acimmune.com
U.S. Investors
Corey Davis, Ph.D.
LifeSci Advisors
Phone: +1 212 915 2577
cdavis@lifesciadvisors.com
U.S. and International Media
Chris Maggos, Cohesion Bureau
Phone: +41 79 367 6254
chris.maggos@cohesionbureau.com
Takeda Media Contacts:
Japanese Media
Yuko Yoneyama
yuko.yoneyama@takeda.com
+81 70-2610-6609
U.S. and International Media
Chris Stamm
chris.stamm@takeda.com
+1 617-374-7726
Takeda Important Notice
For the purposes of this notice, “press release” means this document, any oral presentation, any question and answer session and any written or oral material discussed or distributed by Takeda Pharmaceutical Company Limited (“Takeda”) regarding this release. This press release (including any oral briefing and any question-and-answer in connection with it) is not intended to, and does not constitute, represent or form part of any offer, invitation or solicitation of any offer to purchase, otherwise acquire, subscribe for, exchange, sell or otherwise dispose of, any securities or the solicitation of any vote or approval in any jurisdiction. No shares or other securities are being offered to the public by means of this press release. No offering of securities shall be made in the United States except pursuant to registration under the U.S. Securities Act of 1933, as amended, or an exemption therefrom. This press release is being given (together with any further information which may be provided to the recipient) on the condition that it is for use by the recipient for information purposes only (and not for the evaluation of any investment, acquisition, disposal or any other transaction). Any failure to comply with these restrictions may constitute a violation of applicable securities laws.
The companies in which Takeda directly and indirectly owns investments are separate entities. In this press release, “Takeda” is sometimes used for convenience where references are made to Takeda and its subsidiaries in general. Likewise, the words “we”, “us” and “our” are also used to refer to subsidiaries in general or to those who work for them. These expressions are also used where no useful purpose is served by identifying the particular company or companies.
Takeda Forward-Looking Statements
This press release and any materials distributed in connection with this press release may contain forward-looking statements, beliefs or opinions regarding Takeda’s future business, future position and results of operations, including estimates, forecasts, targets and plans for Takeda. Without limitation,
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forward-looking statements often include words such as “targets”, “plans”, “believes”, “hopes”, “continues”, “expects”, “aims”, “intends”, “ensures”, “will”, “may”, “should”, “would”, “could”, “anticipates”, “estimates”, “projects”, “forecasts”, “outlook” or similar expressions or the negative thereof. These forward-looking statements are based on assumptions about many important factors, including the following, which could cause actual results to differ materially from those expressed or implied by the forward-looking statements: the economic circumstances surrounding Takeda’s global business, including general economic conditions in Japan and the United States; competitive pressures and developments; changes to applicable laws and regulations; challenges inherent in new product development, including uncertainty of clinical success and decisions of regulatory authorities and the timing thereof; uncertainty of commercial success for new and existing products; manufacturing difficulties or delays; fluctuations in interest and currency exchange rates; claims or concerns regarding the safety or efficacy of marketed products or product candidates; the impact of health crises, like the novel coronavirus pandemic; the success of our environmental sustainability efforts, in enabling us to reduce our greenhouse gas emissions or meet our other environmental goals; the extent to which our efforts to increase efficiency, productivity or cost-savings, such as the integration of digital technologies, including artificial intelligence, in our business or other initiatives to restructure our operations will lead to the expected benefits; and other factors identified in Takeda’s most recent Annual Report on Form 20-F and Takeda’s other reports filed with the U.S. Securities and Exchange Commission, available on Takeda’s website at: https://www.takeda.com/investors/sec-filings-and-security-reports/ or at www.sec.gov. Takeda does not undertake to update any of the forward-looking statements contained in this press release or any other forward-looking statements it may make, except as required by law or stock exchange rule. Past performance is not an indicator of future results and the results or statements of Takeda in this press release may not be indicative of, and are not an estimate, forecast, guarantee or projection of Takeda’s future results.
AC Immune Forward Looking Statements
This press release contains statements that constitute “forward-looking statements” within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. Forward-looking statements are statements other than historical fact and may include statements that address future operating, financial or business performance or AC Immune’s strategies or expectations. In some cases, you can identify these statements by forward-looking words such as “may,” “might,” “will,” “should,” “expects,” “plans,” “anticipates,” “believes,” “estimates,” “predicts,” “projects,” “potential,” “outlook” or “continue,” and other comparable terminology. Forward-looking statements are based on management’s current expectations and beliefs and involve significant risks and uncertainties that could cause actual results, developments and business decisions to differ materially from those contemplated by these statements. These risks and uncertainties include those described under the captions “Item 3. Key Information – Risk Factors” and “Item 5. Operating and Financial Review and Prospects” in AC Immune’s Annual Report on Form 20-F and other filings with the Securities and Exchange Commission. Forward- looking statements speak only as of the date they are made, and AC Immune does not undertake any obligation to update them in light of new information, future developments or otherwise, except as may be required under applicable law. All forward-looking statements are qualified in their entirety by this cautionary statement.
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Schedule 10.10
Standard Contractual Clauses
Module 1: Controller to Controller Transfers
Takeda has entered into the Option and License Agreement (“Agreement”) with AC Immune SA (“Company”), under which the Parties will share Personal Data for the purpose of effectuating the rights granted within the Agreement.
The Parties agree that if a Party will store, have access to or otherwise process Personal Data of individuals residing in the European Economic Area (“EEA”), United Kingdom (“UK”) or Switzerland from any location other than (i) the “Safe Cluster” which comprises: countries in the EEA or adequate countries (Andorra, Argentina, Canada (commercial organisations), Faroe Islands, Guernsey, Israel, Isle of Man, Japan, Jersey, New Zealand, Republic of Korea, Switzerland, the UK, Uruguay, or as otherwise provided by the European Commission (at https://ec.europa.eu/info/law/law-topic/data-protection/international-dimension-data-protection/adequacy-decisions_en)) and (ii) specifically for transfers from the UK or Switzerland, any additional countries identified as adequate by the UK or Swiss authorities, then the Parties will comply with the terms set forth in this Module 1 of the European Commission Standard Contractual Clauses (“SCCs”) under which each Party acts as a controller of the EEA, UK or Swiss Personal Data. In the event of a conflict between the SCCs and the Agreement, the SCCs shall prevail.
UK and Swiss transfers. For any storage, access to or processing of Personal Data of individuals residing in the UK or Switzerland, the following amendments to the SCCs shall apply:
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STANDARD CONTRACTUAL CLAUSES
Purpose and scope
| (a) | The purpose of these standard contractual clauses is to ensure compliance with the requirements of Regulation (EU) 2016/679 of the European Parliament and of the Council of 27 April 2016 on the protection of natural persons with regard to the processing of personal data and on the free movement of such data (General Data Protection Regulation) for the transfer of personal data to a third country. |
| (b) | The Parties: |
| (i) | the natural or legal person(s), public authority/ies, agency/ies or other body/ies (hereinafter “entity/ies”) transferring the personal data, as listed in Annex I.A. (hereinafter each “data exporter”), and |
| (ii) | the entity/ies in a third country receiving the personal data from the data exporter, directly or indirectly via another entity also Party to these Clauses, as listed in Annex I.A. (hereinafter each “data importer”) |
have agreed to these standard contractual clauses (hereinafter: “Clauses”).
| (c) | These Clauses apply with respect to the transfer of personal data as specified in Annex I.B. |
| (d) | The Appendix to these Clauses containing the Annexes referred to therein forms an integral part of these Clauses. |
Effect and invariability of the Clauses
| (a) | These Clauses set out appropriate safeguards, including enforceable data subject rights and effective legal remedies, pursuant to Article 46(1) and Article 46 (2)(c) of Regulation (EU) 2016/679 and, with respect to data transfers from controllers to processors and/or processors to processors, standard contractual clauses pursuant to Article 28(7) of Regulation (EU) 2016/679, provided they are not modified, except to select the appropriate Module(s) or to add or update information in the Appendix. This does not prevent the Parties from including the standard contractual clauses laid down in these Clauses in a wider contract and/or to add other clauses or additional safeguards, provided that they do not contradict, directly or indirectly, these Clauses or prejudice the fundamental rights or freedoms of data subjects. |
| (b) | These Clauses are without prejudice to obligations to which the data exporter is subject by virtue of Regulation (EU) 2016/679. |
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Third-party beneficiaries
| (a) | Data subjects may invoke and enforce these Clauses, as third-party beneficiaries, against the data exporter and/or data importer, with the following exceptions: |
| (i) | Clause 1, Clause 2, Clause 3, Clause 6, Clause 7; |
| (ii) | Clause 8 - Clause 8.5(e) and Clause 8.9(b); |
| (iii) | Clause 12 - Clause 12(a) and (d); |
| (iv) | Clause 13; |
| (v) | Clause 15.1(c), (d) and (e); |
| (vi) | Clause 16(e); |
| (vii) | Clause 18 - Clause 18(a) and (b). |
| (b) | Paragraph (a) is without prejudice to rights of data subjects under Regulation (EU) 2016/679. |
Interpretation
| (a) | Where these Clauses use terms that are defined in Regulation (EU) 2016/679, those terms shall have the same meaning as in that Regulation. |
| (b) | These Clauses shall be read and interpreted in the light of the provisions of Regulation (EU) 2016/679. |
| (c) | These Clauses shall not be interpreted in a way that conflicts with rights and obligations provided for in Regulation (EU) 2016/679. |
Hierarchy
In the event of a contradiction between these Clauses and the provisions of related agreements between the Parties, existing at the time these Clauses are agreed or entered into thereafter, these Clauses shall prevail.
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Description of the transfer(s)
The details of the transfer(s), and in particular the categories of personal data that are transferred and the purpose(s) for which they are transferred, are specified in Annex I.B.
Docking clause
| (a) | An entity that is not a Party to these Clauses may, with the agreement of the Parties, accede to these Clauses at any time, either as a data exporter or as a data importer, by completing the Appendix and signing Annex I.A. |
| (b) | Once it has completed the Appendix and signed Annex I.A, the acceding entity shall become a Party to these Clauses and have the rights and obligations of a data exporter or data importer in accordance with its designation in Annex I.A. |
| (c) | The acceding entity shall have no rights or obligations arising under these Clauses from the period prior to becoming a Party. |
Data protection safeguards
The data exporter warrants that it has used reasonable efforts to determine that the data importer is able, through the implementation of appropriate technical and organisational measures, to satisfy its obligations under these Clauses.
| 8.1 | Purpose limitation |
| 1. | The data importer shall process the personal data only for the specific purpose(s) of the transfer, as set out in Annex I. B. It may only process the personal data for another purpose: |
| (i) | where it has obtained the data subject’s prior consent; |
| (ii) | where necessary for the establishment, exercise or defence of legal claims in the context of specific administrative, regulatory or judicial proceedings; or |
| (iii) | where necessary in order to protect the vital interests of the data subject or of another natural person. |
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| 8.2 | Transparency |
| (a) | In order to enable data subjects to effectively exercise their rights pursuant to Clause 10, the data importer shall inform them, either directly or through the data exporter: |
| (i) | of its identity and contact details; |
| (ii) | of the categories of personal data processed; |
| (iii) | of the right to obtain a copy of these Clauses; |
| (iv) | where it intends to onward transfer the personal data to any third party/ies, of the recipient or categories of recipients (as appropriate with a view to providing meaningful information), the purpose of such onward transfer and the ground therefore pursuant to Clause 8.7. |
| (b) | Paragraph (a) shall not apply where the data subject already has the information, including when such information has already been provided by the data exporter, or providing the information proves impossible or would involve a disproportionate effort for the data importer. In the latter case, the data importer shall, to the extent possible, make the information publicly available. |
| (c) | On request, the Parties shall make a copy of these Clauses, including the Appendix as completed by them, available to the data subject free of charge. To the extent necessary to protect business secrets or other confidential information, including personal data, the Parties may redact part of the text of the Appendix prior to sharing a copy, but shall provide a meaningful summary where the data subject would otherwise not be able to understand its content or exercise his/her rights. On request, the Parties shall provide the data subject with the reasons for the redactions, to the extent possible without revealing the redacted information. |
| (d) | Paragraphs (a) to (c) are without prejudice to the obligations of the data exporter under Articles 13 and 14 of Regulation (EU) 2016/679. |
| 8.3 | Accuracy and data minimisation |
| (a) | Each Party shall ensure that the personal data is accurate and, where necessary, kept up to date. The data importer shall take every reasonable step to ensure that personal data that |
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| is inaccurate, having regard to the purpose(s) of processing, is erased or rectified without delay. |
| (b) | If one of the Parties becomes aware that the personal data it has transferred or received is inaccurate, or has become outdated, it shall inform the other Party without undue delay. |
| (c) | The data importer shall ensure that the personal data is adequate, relevant and limited to what is necessary in relation to the purpose(s) of processing. |
| 8.4 | Storage limitation |
The data importer shall retain the personal data for no longer than necessary for the purpose(s) for which it is processed. It shall put in place appropriate technical or organisational measures to ensure compliance with this obligation, including erasure or anonymisation of the data and all back-ups at the end of the retention period.
| 8.5 | Security of processing |
| (a) | The data importer and, during transmission, also the data exporter shall implement appropriate technical and organisational measures to ensure the security of the personal data, including protection against a breach of security leading to accidental or unlawful destruction, loss, alteration, unauthorised disclosure or access (hereinafter “personal data breach”). In assessing the appropriate level of security, they shall take due account of the state of the art, the costs of implementation, the nature, scope, context and purpose(s) of processing and the risks involved in the processing for the data subject. The Parties shall in particular consider having recourse to encryption or pseudonymisation, including during transmission, where the purpose of processing can be fulfilled in that manner. |
| (b) | The Parties have agreed on the technical and organisational measures set out in Annex II. The data importer shall carry out regular checks to ensure that these measures continue to provide an appropriate level of security. |
| (c) | The data importer shall ensure that persons authorised to process the personal data have committed themselves to confidentiality or are under an appropriate statutory obligation of confidentiality. |
| (d) | In the event of a personal data breach concerning personal data processed by the data importer under these Clauses, the data importer shall take appropriate measures to address the personal data breach, including measures to mitigate its possible adverse effects. |
| (e) | In case of a personal data breach that is likely to result in a risk to the rights and freedoms of natural persons, the data importer shall without undue delay notify both the data exporter and the competent supervisory authority pursuant to Clause 13. Such notification shall contain i) a description of the nature of the breach (including, where possible, categories and approximate number of data subjects and personal data records concerned), ii) its likely consequences, iii) the measures taken or proposed to address the breach, and iv) the details of a contact point from whom more information can be |
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| obtained. To the extent it is not possible for the data importer to provide all the information at the same time, it may do so in phases without undue further delay. |
| (f) | In case of a personal data breach that is likely to result in a high risk to the rights and freedoms of natural persons, the data importer shall also notify without undue delay the data subjects concerned of the personal data breach and its nature, if necessary in cooperation with the data exporter, together with the information referred to in paragraph (e), points ii) to iv), unless the data importer has implemented measures to significantly reduce the risk to the rights or freedoms of natural persons, or notification would involve disproportionate efforts. In the latter case, the data importer shall instead issue a public communication or take a similar measure to inform the public of the personal data breach. |
| (g) | The data importer shall document all relevant facts relating to the personal data breach, including its effects and any remedial action taken, and keep a record thereof. |
| 8.6 | Sensitive data |
Where the transfer involves personal data revealing racial or ethnic origin, political opinions, religious or philosophical beliefs, or trade union membership, genetic data, or biometric data for the purpose of uniquely identifying a natural person, data concerning health or a person’s sex life or sexual orientation, or data relating to criminal convictions or offences (hereinafter “sensitive data”), the data importer shall apply specific restrictions and/or additional safeguards adapted to the specific nature of the data and the risks involved. This may include restricting the personnel permitted to access the personal data, additional security measures (such as pseudonymisation) and/or additional restrictions with respect to further disclosure.
| 8.7 | Onward transfers |
The data importer shall not disclose the personal data to a third party located outside the European Union (in the same country as the data importer or in another third country, hereinafter “onward transfer”) unless the third party is or agrees to be bound by these Clauses, under the appropriate Module. Otherwise, an onward transfer by the data importer may only take place if:
| (i) | it is to a country benefitting from an adequacy decision pursuant to Article 45 of Regulation (EU) 2016/679 that covers the onward transfer; |
| (ii) | the third party otherwise ensures appropriate safeguards pursuant to Articles 46 or 47 of Regulation (EU) 2016/679 with respect to the processing in question; |
| (iii) | the third party enters into a binding instrument with the data importer ensuring the same level of data protection as under these Clauses, and the data importer provides a copy of these safeguards to the data exporter; |
| (iv) | it is necessary for the establishment, exercise or defence of legal claims in the context of specific administrative, regulatory or judicial proceedings; |
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| (v) | it is necessary in order to protect the vital interests of the data subject or of another natural person; or |
| (vi) | where none of the other conditions apply, the data importer has obtained the explicit consent of the data subject for an onward transfer in a specific situation, after having informed him/her of its purpose(s), the identity of the recipient and the possible risks of such transfer to him/her due to the lack of appropriate data protection safeguards. In this case, the data importer shall inform the data exporter and, at the request of the latter, shall transmit to it a copy of the information provided to the data subject. |
Any onward transfer is subject to compliance by the data importer with all the other safeguards under these Clauses, in particular purpose limitation.
| 8.8 | Processing under the authority of the data importer |
The data importer shall ensure that any person acting under its authority, including a processor, processes the data only on its instructions.
| 8.9 | Documentation and compliance |
| (a) | Each Party shall be able to demonstrate compliance with its obligations under these Clauses. In particular, the data importer shall keep appropriate documentation of the processing activities carried out under its responsibility. |
| (b) | The data importer shall make such documentation available to the competent supervisory authority on request. |
Use of sub-processors
| (a) | Intentionally omitted. |
Data subject rights
| (a) | The data importer, where relevant with the assistance of the data exporter, shall deal with any enquiries and requests it receives from a data subject relating to the processing of his/her personal data and the exercise of his/her rights under these Clauses without undue delay and at the latest within one month of the receipt of the enquiry or request. The data importer shall take appropriate measures to facilitate such enquiries, requests and the exercise of data subject rights. Any information provided to the data subject shall be in an intelligible and easily accessible form, using clear and plain language. |
| (b) | In particular, upon request by the data subject the data importer shall, free of charge: |
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| (i) | provide confirmation to the data subject as to whether personal data concerning him/her is being processed and, where this is the case, a copy of the data relating to him/her and the information in Annex I; if personal data has been or will be onward transferred, provide information on recipients or categories of recipients (as appropriate with a view to providing meaningful information) to which the personal data has been or will be onward transferred, the purpose of such onward transfers and their ground pursuant to Clause 8.7; and provide information on the right to lodge a complaint with a supervisory authority in accordance with Clause 12(c)(i); |
| (ii) | rectify inaccurate or incomplete data concerning the data subject; |
| (iii) | erase personal data concerning the data subject if such data is being or has been processed in violation of any of these Clauses ensuring third-party beneficiary rights, or if the data subject withdraws the consent on which the processing is based. |
| (c) | Where the data importer processes the personal data for direct marketing purposes, it shall cease processing for such purposes if the data subject objects to it. |
| (d) | The data importer shall not make a decision based solely on the automated processing of the personal data transferred (hereinafter “automated decision”), which would produce legal effects concerning the data subject or similarly significantly affect him/her, unless with the explicit consent of the data subject or if authorised to do so under the laws of the country of destination, provided that such laws lays down suitable measures to safeguard the data subject’s rights and legitimate interests. In this case, the data importer shall, where necessary in cooperation with the data exporter: |
| (i) | inform the data subject about the envisaged automated decision, the envisaged consequences and the logic involved; and |
| (ii) | implement suitable safeguards, at least by enabling the data subject to contest the decision, express his/her point of view and obtain review by a human being. |
| (e) | Where requests from a data subject are excessive, in particular because of their repetitive character, the data importer may either charge a reasonable fee taking into account the administrative costs of granting the request or refuse to act on the request. |
| (f) | The data importer may refuse a data subject’s request if such refusal is allowed under the laws of the country of destination and is necessary and proportionate in a democratic society to protect one of the objectives listed in Article 23(1) of Regulation (EU) 2016/679. |
| (g) | If the data importer intends to refuse a data subject’s request, it shall inform the data subject of the reasons for the refusal and the possibility of lodging a complaint with the competent supervisory authority and/or seeking judicial redress. |
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Redress
| (a) | The data importer shall inform data subjects in a transparent and easily accessible format, through individual notice or on its website, of a contact point authorised to handle complaints. It shall deal promptly with any complaints it receives from a data subject. |
| (b) | In case of a dispute between a data subject and one of the Parties as regards compliance with these Clauses, that Party shall use its best efforts to resolve the issue amicably in a timely fashion. The Parties shall keep each other informed about such disputes and, where appropriate, cooperate in resolving them. |
| (c) | Where the data subject invokes a third-party beneficiary right pursuant to Clause 3, the data importer shall accept the decision of the data subject to: |
| (i) | lodge a complaint with the supervisory authority in the Member State of his/her habitual residence or place of work, or the competent supervisory authority pursuant to Clause 13; |
| (ii) | refer the dispute to the competent courts within the meaning of Clause 18. |
| (d) | The Parties accept that the data subject may be represented by a not-for-profit body, organisation or association under the conditions set out in Article 80(1) of Regulation (EU) 2016/679. |
| (e) | The data importer shall abide by a decision that is binding under the applicable EU or Member State law. |
| (f) | The data importer agrees that the choice made by the data subject will not prejudice his/her substantive and procedural rights to seek remedies in accordance with applicable laws. |
Liability
| (a) | Each Party shall be liable to the other Party/ies for any damages it causes the other Party/ies by any breach of these Clauses. |
| (b) | Each Party shall be liable to the data subject, and the data subject shall be entitled to receive compensation, for any material or non-material damages that the Party causes the data subject by breaching the third-party beneficiary rights under these Clauses. This is without prejudice to the liability of the data exporter under Regulation (EU) 2016/679. |
| (c) | Where more than one Party is responsible for any damage caused to the data subject as a result of a breach of these Clauses, all responsible Parties shall be jointly and severally liable and the data subject is entitled to bring an action in court against any of these Parties. |
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| (d) | The Parties agree that if one Party is held liable under paragraph (c), it shall be entitled to claim back from the other Party/ies that part of the compensation corresponding to its/their responsibility for the damage. |
| (e) | The data importer may not invoke the conduct of a processor or sub-processor to avoid its own liability. |
Supervision
| (a) | [[Where the data exporter is established in an EU Member State:] The supervisory authority with responsibility for ensuring compliance by the data exporter with Regulation (EU) 2016/679 as regards the data transfer, as indicated in Annex I.C, shall act as competent supervisory authority. |
[Where the data exporter is not established in an EU Member State, but falls within the territorial scope of application of Regulation (EU) 2016/679 in accordance with its Article 3(2) and has appointed a representative pursuant to Article 27(1) of Regulation (EU) 2016/679:] The supervisory authority of the Member State in which the representative within the meaning of Article 27(1) of Regulation (EU) 2016/679 is established, as indicated in Annex I.C, shall act as competent supervisory authority.
[Where the data exporter is not established in an EU Member State, but falls within the territorial scope of application of Regulation (EU) 2016/679 in accordance with its Article 3(2) without however having to appoint a representative pursuant to Article 27(2) of Regulation (EU) 2016/679:] The supervisory authority of one of the Member States in which the data subjects whose personal data is transferred under these Clauses in relation to the offering of goods or services to them, or whose behaviour is monitored, are located, as indicated in Annex I.C, shall act as competent supervisory authority.]
| (b) | The data importer agrees to submit itself to the jurisdiction of and cooperate with the competent supervisory authority in any procedures aimed at ensuring compliance with these Clauses. In particular, the data importer agrees to respond to enquiries, submit to audits and comply with the measures adopted by the supervisory authority, including remedial and compensatory measures. It shall provide the supervisory authority with written confirmation that the necessary actions have been taken. |
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Local laws and practices affecting compliance with the Clauses
| (a) | The Parties warrant that they have no reason to believe that the laws and practices in the third country of destination applicable to the processing of the personal data by the data importer, including any requirements to disclose personal data or measures authorising access by public authorities, prevent the data importer from fulfilling its obligations under these Clauses. This is based on the understanding that laws and practices that respect the essence of the fundamental rights and freedoms and do not exceed what is necessary and proportionate in a democratic society to safeguard one of the objectives listed in Article 23(1) of Regulation (EU) 2016/679, are not in contradiction with these Clauses. |
| (b) | The Parties declare that in providing the warranty in paragraph (a), they have taken due account in particular of the following elements: |
| (i) | the specific circumstances of the transfer, including the length of the processing chain, the number of actors involved and the transmission channels used; intended onward transfers; the type of recipient; the purpose of processing; the categories and format of the transferred personal data; the economic sector in which the transfer occurs; the storage location of the data transferred; |
| (ii) | the laws and practices of the third country of destination – including those requiring the disclosure of data to public authorities or authorising access by such authorities – relevant in light of the specific circumstances of the transfer, and the applicable limitations and safeguards; |
| (iii) | any relevant contractual, technical or organisational safeguards put in place to supplement the safeguards under these Clauses, including measures applied during transmission and to the processing of the personal data in the country of destination. |
| (c) | The data importer warrants that, in carrying out the assessment under paragraph (b), it has made its best efforts to provide the data exporter with relevant information and agrees that it will continue to cooperate with the data exporter in ensuring compliance with these Clauses. |
| (d) | The Parties agree to document the assessment under paragraph (b) and make it available to the competent supervisory authority on request. |
| (e) | The data importer agrees to notify the data exporter promptly if, after having agreed to these Clauses and for the duration of the contract, it has reason to believe that it is or has become subject to laws or practices not in line with the requirements under paragraph (a), including following a change in the laws of the third country or a measure (such as a |
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| disclosure request) indicating an application of such laws in practice that is not in line with the requirements in paragraph (a). |
| (f) | Following a notification pursuant to paragraph (e), or if the data exporter otherwise has reason to believe that the data importer can no longer fulfil its obligations under these Clauses, the data exporter shall promptly identify appropriate measures (e.g. technical or organisational measures to ensure security and confidentiality) to be adopted by the data exporter and/or data importer to address the situation. The data exporter shall suspend the data transfer if it considers that no appropriate safeguards for such transfer can be ensured, or if instructed by the competent supervisory authority to do so. In this case, the data exporter shall be entitled to terminate the contract, insofar as it concerns the processing of personal data under these Clauses. If the contract involves more than two Parties, the data exporter may exercise this right to termination only with respect to the relevant Party, unless the Parties have agreed otherwise. Where the contract is terminated pursuant to this Clause, Clause 16(d) and (e) shall apply. |
Obligations of the data importer in case of access by public authorities
| 15.1 | Notification |
| (a) | The data importer agrees to notify the data exporter and, where possible, the data subject promptly (if necessary with the help of the data exporter) if it: |
| (i) | receives a legally binding request from a public authority, including judicial authorities, under the laws of the country of destination for the disclosure of personal data transferred pursuant to these Clauses; such notification shall include information about the personal data requested, the requesting authority, the legal basis for the request and the response provided; or |
| (ii) | becomes aware of any direct access by public authorities to personal data transferred pursuant to these Clauses in accordance with the laws of the country of destination; such notification shall include all information available to the importer. |
| (b) | If the data importer is prohibited from notifying the data exporter and/or the data subject under the laws of the country of destination, the data importer agrees to use its best efforts to obtain a waiver of the prohibition, with a view to communicating as much information as possible, as soon as possible. The data importer agrees to document its best efforts in order to be able to demonstrate them on request of the data exporter. |
| (c) | Where permissible under the laws of the country of destination, the data importer agrees to provide the data exporter, at regular intervals for the duration of the contract, with as much relevant information as possible on the requests received (in particular, number of requests, type of data requested, requesting authority/ies, whether requests have been challenged and the outcome of such challenges, etc.). |
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| (d) | The data importer agrees to preserve the information pursuant to paragraphs (a) to (c) for the duration of the contract and make it available to the competent supervisory authority on request. |
| (e) | Paragraphs (a) to (c) are without prejudice to the obligation of the data importer pursuant to Clause 14(e) and Clause 16 to inform the data exporter promptly where it is unable to comply with these Clauses. |
| 15.2 | Review of legality and data minimisation |
| (a) | The data importer agrees to review the legality of the request for disclosure, in particular whether it remains within the powers granted to the requesting public authority, and to challenge the request if, after careful assessment, it concludes that there are reasonable grounds to consider that the request is unlawful under the laws of the country of destination, applicable obligations under international law and principles of international comity. The data importer shall, under the same conditions, pursue possibilities of appeal. When challenging a request, the data importer shall seek interim measures with a view to suspending the effects of the request until the competent judicial authority has decided on its merits. It shall not disclose the personal data requested until required to do so under the applicable procedural rules. These requirements are without prejudice to the obligations of the data importer under Clause 14(e). |
| (b) | The data importer agrees to document its legal assessment and any challenge to the request for disclosure and, to the extent permissible under the laws of the country of destination, make the documentation available to the data exporter. It shall also make it available to the competent supervisory authority on request. |
| (c) | The data importer agrees to provide the minimum amount of information permissible when responding to a request for disclosure, based on a reasonable interpretation of the request. |
Non-compliance with the Clauses and termination
| (a) | The data importer shall promptly inform the data exporter if it is unable to comply with these Clauses, for whatever reason. |
| (b) | In the event that the data importer is in breach of these Clauses or unable to comply with these Clauses, the data exporter shall suspend the transfer of personal data to the data importer until compliance is again ensured or the contract is terminated. This is without prejudice to Clause 14(f). |
| (c) | The data exporter shall be entitled to terminate the contract, insofar as it concerns the processing of personal data under these Clauses, where: |
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| (i) | the data exporter has suspended the transfer of personal data to the data importer pursuant to paragraph (b) and compliance with these Clauses is not restored within a reasonable time and in any event within one month of suspension; |
| (ii) | the data importer is in substantial or persistent breach of these Clauses; or |
| (iii) | the data importer fails to comply with a binding decision of a competent court or supervisory authority regarding its obligations under these Clauses. |
In these cases, it shall inform the competent supervisory authority of such non-compliance. Where the contract involves more than two Parties, the data exporter may exercise this right to termination only with respect to the relevant Party, unless the Parties have agreed otherwise.
| (d) | Personal data that has been transferred prior to the termination of the contract pursuant to paragraph (c) shall at the choice of the data exporter immediately be returned to the data exporter or deleted in its entirety. The same shall apply to any copies of the data. The data importer shall certify the deletion of the data to the data exporter. Until the data is deleted or returned, the data importer shall continue to ensure compliance with these Clauses. In case of local laws applicable to the data importer that prohibit the return or deletion of the transferred personal data, the data importer warrants that it will continue to ensure compliance with these Clauses and will only process the data to the extent and for as long as required under that local law. |
| (e) | Either Party may revoke its agreement to be bound by these Clauses where (i) the European Commission adopts a decision pursuant to Article 45(3) of Regulation (EU) 2016/679 that covers the transfer of personal data to which these Clauses apply; or (ii) Regulation (EU) 2016/679 becomes part of the legal framework of the country to which the personal data is transferred. This is without prejudice to other obligations applying to the processing in question under Regulation (EU) 2016/679. |
Governing law
These Clauses shall be governed by the law of one of the EU Member States, provided such law allows for third-party beneficiary rights. The Parties agree that this shall be the law of Ireland.
Choice of forum and jurisdiction
| (a) | Any dispute arising from these Clauses shall be resolved by the courts of an EU Member State. |
| (b) | The Parties agree that those shall be the courts of Ireland. |
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| (c) | A data subject may also bring legal proceedings against the data exporter and/or data importer before the courts of the Member State in which he/she has his/her habitual residence. |
| (d) | The Parties agree to submit themselves to the jurisdiction of such courts. |
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[***]
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[***]
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ANNEX III to Module I
UK Addendum to the
EU Commission Standard Contractual Clauses
EU Commission Standard Contractual Clauses
This Addendum has been issued by the Information Commissioner for Parties making Restricted Transfers. The Information Commissioner considers that it provides Appropriate Safeguards for Restricted Transfers when it is entered into as a legally binding contract.
Part 1: Tables
Table 1: Parties
Start Date | The date of this Agreement. |
The Parties | |
Parties’ details | The details of the data exporter and the data importer can be found in Annex 1.A. of the attached EU SCCs. |
Key Contact | Key Contact information of the data exporter and the data importer can be found in Annex 1.A. of the attached EU SCCs. |
Table 2: Selected SCCs, Modules and Selected Clauses
Addendum EU SCCS | ☒ | The version of the Approved EU SCCs which this Addendum is appended to including the Appendix Information. | ||||||
OR | ||||||||
☐ | the Approved EU SCCs, including the Appendix Information and with only the following modules, clauses or optional provisions of the Approved EU SCCs brought into effect for the purposes of this Addendum: | |||||||
| Module | Module in operation | Clause 7 (Docking Clause) | Clause 11 (Option) | Clause 9a (Prior Authorisation or General Authorisation) | Clause 9a (Time Period) | Is personal data received from the Importer combined with personal data collected by the Exporter? | |
1 | | | | | | | ||
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| 2 | | | | | | | |
3 | | | | | | | ||
4 | | | | | | | ||
Table 3: Appendix Information
“Appendix Information” means the information which must be provided for the selected modules as set out in the Appendix of the Approved EU SCCs (other than the Parties), and which for this Addendum is set out in the Annexes to the Approved EU SCCs which this Addendum is appended to.
Table 4: Ending this Addendum when the Approved Addendum Changes
Ending this Addendum when the Approved Addendum changes | Which Parties may end this Addendum as set out in Section 19: | |
☒ | Importer | |
☒ | Exporter | |
☐ | neither Party | |
Part 2: Mandatory Clauses
Entering into this Addendum
| 1. | Each Party agrees to be bound by the terms and conditions set out in this Addendum, in exchange for the other Party also agreeing to be bound by this Addendum. |
| 2. | Although Annex 1A and Clause 7 of the Approved EU SCCs require signature by the Parties, for the purpose of making Restricted Transfers, the Parties may enter into this Addendum in any way that makes them legally binding on the Parties and allows data subjects to enforce their rights as set out in this Addendum. Entering into this Addendum will have the same effect as signing the Approved EU SCCs and any part of the Approved EU SCCs. |
Interpretation of this Addendum
| 3. | Where this Addendum uses terms that are defined in the Approved EU SCCs those terms shall have the same meaning as in the Approved EU SCCs. In addition, the following terms have the following meanings: |
Term | Meaning |
Addendum | This International Data Transfer Addendum which is made up of this Addendum incorporating the Addendum EU SCCs. |
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Addendum EU SCCs | The version(s) of the Approved EU SCCs which this Addendum is appended to, as set out in Table 2, including the Appendix Information. |
Appendix Information | As set out in Table 3. |
Appropriate Safeguards | The standard of protection over the personal data and of data subjects’ rights, which is required by UK Data Protection Laws when you are making a Restricted Transfer relying on standard data protection clauses under Article 46(2)(d) UK GDPR. |
Approved Addendum | The template Addendum issued by the ICO and laid before Parliament in accordance with s119A of the Data Protection Act 2018 on 2 February 2022, as it is revised under Section 18. |
Approved EU SCCs | The Standard Contractual Clauses set out in the Annex of Commission Implementing Decision (EU) 2021/914 of 4 June 2021. |
ICO | The Information Commissioner. |
Restricted Transfer | A transfer which is covered by Chapter V of the UK GDPR. |
UK | The United Kingdom of Great Britain and Northern Ireland. |
UK Data | All laws relating to data protection, the processing of personal data, privacy and/or electronic communications in force from time to time in the UK, including the UK GDPR and the Data Protection Act 2018. |
UK GDPR | As defined in section 3 of the Data Protection Act 2018. |
| 4. | This Addendum must always be interpreted in a manner that is consistent with UK Data Protection Laws and so that it fulfils the Parties’ obligation to provide the Appropriate Safeguards. |
| 5. | If the provisions included in the Addendum EU SCCs amend the Approved SCCs in any way which is not permitted under the Approved EU SCCs or the Approved Addendum, such amendment(s) will not be incorporated in this Addendum and the equivalent provision of the Approved EU SCCs will take their place. |
| 6. | If there is any inconsistency or conflict between UK Data Protection Laws and this Addendum, UK Data Protection Laws applies. |
| 7. | If the meaning of this Addendum is unclear or there is more than one meaning, the meaning which most closely aligns with UK Data Protection Laws applies. |
| 8. | Any references to legislation (or specific provisions of legislation) means that legislation (or specific provision) as it may change over time. This includes where that legislation (or specific provision) has been consolidated, re- enacted and/or replaced after this Addendum has been entered into. |
| | |
Hierarchy
| 9. | Although Clause 5 of the Approved EU SCCs sets out that the Approved EU SCCs prevail over all related agreements between the parties, the parties agree that, for Restricted Transfers, the hierarchy in Section 10 will prevail. |
| 10. | Where there is any inconsistency or conflict between the Approved Addendum and the Addendum EU SCCs (as applicable), the Approved Addendum overrides the Addendum EU SCCs, except where (and in so far as) the inconsistent or conflicting terms of the Addendum EU SCCs provides greater protection for data subjects, in which case those terms will override the Approved Addendum. |
| 11. | Where this Addendum incorporates Addendum EU SCCs which have been entered into to protect transfers subject to the General Data Protection Regulation (EU) 2016/679 then the Parties acknowledge that nothing in this Addendum impacts those Addendum EU SCCs. |
Incorporation of and changes to the EU SCCs
| 12. | This Addendum incorporates the Addendum EU SCCs which are amended to the extent necessary so that: |
| a. | together they operate for data transfers made by the data exporter to the data importer, to the extent that UK Data Protection Laws apply to the data exporter’s processing when making that data transfer, and they provide Appropriate Safeguards for those data transfers; |
| b. | Sections 9 to 11 override Clause 5 (Hierarchy) of the Addendum EU SCCs; and |
| c. | this Addendum (including the Addendum EU SCCs incorporated into it) is (1) governed by the laws of England and Wales and (2) any dispute arising from it is resolved by the courts of England and Wales, in each case unless the laws and/or courts of Scotland or Northern Ireland have been expressly selected by the Parties. |
| 13. | Unless the Parties have agreed alternative amendments which meet the requirements of Section 12, the provisions of Section 15 will apply. |
| 14. | No amendments to the Approved EU SCCs other than to meet the requirements of Section 12 may be made. |
| 15. | The following amendments to the Addendum EU SCCs (for the purpose of Section 12) are made: |
| a. | References to the “Clauses” means this Addendum, incorporating the Addendum EU SCCs; |
| b. | In Clause 2, delete the words: |
“and, with respect to data transfers from controllers to processors and/or processors to processors, standard contractual clauses pursuant to Article 28(7) of Regulation (EU) 2016/679”;
| c. | Clause 6 (Description of the transfer(s)) is replaced with: |
“The details of the transfers(s) and in particular the categories of personal data that are transferred and
| | |
the purpose(s) for which they are transferred are those specified in Annex I.B where UK Data Protection Laws apply to the data exporter’s processing when making that transfer.”;
| d. | Clause 8.7(i) of Module 1 is replaced with: |
“it is to a country benefitting from adequacy regulations pursuant to Section 17A of the UK GDPR that covers the onward transfer”;
| e. | Clause 8.8(i) of Modules 2 and 3 is replaced with: |
“the onward transfer is to a country benefitting from adequacy regulations pursuant to Section 17A of the UK GDPR that covers the onward transfer;”
| f. | References to “Regulation (EU) 2016/679”, “Regulation (EU) 2016/679 of the European Parliament and of the Council of 27 April 2016 on the protection of natural persons with regard to the processing of personal data and on the free movement of such data (General Data Protection Regulation)”and “that Regulation” are all replaced by “UK Data Protection Laws”. References to specific Article(s) of “Regulation (EU) 2016/679” are replaced with the equivalent Article or Section of UK Data Protection Laws; |
| g. | References to Regulation (EU) 2018/1725 are removed; |
| h. | References to the “European Union”, “Union”, “EU”, “EU Member State”, “Member State” and “EU or Member State” are all replaced with the “UK”; |
| i. | The reference to “Clause 12(c)(i)” at Clause 10(b)(i) of Module one, is replaced with “Clause 11(c)(i)”; |
| j. | Clause 13(a) and Part C of Annex I are not used; |
| k. | The “competent supervisory authority” and “supervisory authority” are both replaced with the “Information Commissioner”; |
| l. | In Clause 16(e), subsection (i) is replaced with: |
“the Secretary of State makes regulations pursuant to Section 17A of the Data Protection Act 2018 that cover the transfer of personal data to which these clauses apply;”;
| m. | Clause 17 is replaced with: |
“These Clauses are governed by the laws of England and Wales.”;
| n. | Clause 18 is replaced with: |
“Any dispute arising from these Clauses shall be resolved by the courts of England and Wales. A data subject may also bring legal proceedings against the data exporter and/or data importer before the courts of any country in the UK. The Parties agree to submit themselves to the jurisdiction of such courts.”; and
| o. | The footnotes to the Approved EU SCCs do not form part of the Addendum, except for footnotes 8, 9, 10 and 11. |
| | |
Amendments to this Addendum
| 16. | The Parties may agree to change Clauses 17 and/or 18 of the Addendum EU SCCs to refer to the laws and/or courts of Scotland or Northern Ireland. |
| 17. | If the Parties wish to change the format of the information included in Part 1: Tables of the Approved Addendum, they may do so by agreeing to the change in writing, provided that the change does not reduce the Appropriate Safeguards. |
| 18. | From time to time, the ICO may issue a revised Approved Addendum which: |
| a. | makes reasonable and proportionate changes to the Approved Addendum, including correcting errors in the Approved Addendum; and/or |
| b. | reflects changes to UK Data Protection Laws; |
The revised Approved Addendum will specify the start date from which the changes to the Approved Addendum are effective and whether the Parties need to review this Addendum including the Appendix Information. This Addendum is automatically amended as set out in the revised Approved Addendum from the start date specified.
| 19. | If the ICO issues a revised Approved Addendum under Section 18, if any Party selected in Table 4 “Ending the Addendum when the Approved Addendum changes”, will as a direct result of the changes in the Approved Addendum have a substantial, disproportionate and demonstrable increase in: |
| a. | its direct costs of performing its obligations under the Addendum; and/or |
| b. | its risk under the Addendum, |
and in either case it has first taken reasonable steps to reduce those costs or risks so that it is not substantial and disproportionate, then that Party may end this Addendum at the end of a reasonable notice period, by providing written notice for that period to the other Party before the start date of the revised Approved Addendum.
| 20. | The Parties do not need the consent of any third party to make changes to this Addendum, but any changes must be made in accordance with its terms. |
| | |
[***]
| | |
[***]
| | |
[***]
Exhibit 99.1
Condensed Consolidated Balance Sheets (Unaudited)
(In CHF thousands)
As of | ||||||
June 30, | December 31, | |||||
| Note |
| 2024 |
| 2023 | |
Assets |
|
|
|
|
|
|
Non-current assets |
|
|
|
|
|
|
Property, plant and equipment |
| 5 |
| |
| |
Right-of-use assets |
| 6 |
| |
| |
Intangible asset |
| 8 |
| |
| |
Long-term financial assets |
| 6 |
| |
| |
Total non-current assets |
| |
| | ||
Current assets |
|
| ||||
Prepaid expenses |
| 9 |
| |
| |
Accrued income |
|
| |
| | |
Other current receivables |
|
| |
| | |
Accounts receivable | 11 | — | | |||
Short-term financial assets |
| 10 |
| |
| |
Cash and cash equivalents |
| 10 |
| |
| |
Total current assets |
| |
| | ||
Total assets |
| |
| | ||
Shareholders' equity and liabilities |
|
| ||||
Shareholders’ equity |
|
| ||||
Share capital |
| 12 |
| |
| |
Share premium |
|
| |
| | |
Treasury shares |
| 12 |
| ( |
| ( |
Currency translation differences | ( | ( | ||||
Accumulated losses |
| ( |
| ( | ||
Total shareholders’ equity |
| |
| | ||
Non-current liabilities |
|
| ||||
Long-term deferred contract revenue | 3 | | — | |||
Long-term lease liabilities |
| 6 |
| |
| |
Net employee defined benefit liabilities |
|
| |
| | |
Total non-current liabilities |
| |
| | ||
Current liabilities |
|
| ||||
Trade and other payables |
|
| |
| | |
Accrued expenses |
| 7 |
| |
| |
Short-term deferred income |
|
| |
| | |
Short-term deferred contract revenue | 3 | | — | |||
Short-term lease liabilities |
| 6 |
| |
| |
Total current liabilities |
| |
| | ||
Total liabilities |
| |
| | ||
Total shareholders’ equity and liabilities |
| |
| | ||
The accompanying notes are an integral part of these Interim Condensed Consolidated Financial Statements (Unaudited).
Condensed Consolidated Statements of Income/(Loss) (Unaudited)
(In CHF thousands except for per share data)
For the Three Months | For the Six Months | |||||||||
Ended June 30, | Ended June 30, | |||||||||
Note | 2024 | 2023 | 2024 | 2023 | ||||||
Revenue |
|
|
|
|
|
|
|
|
|
|
Contract revenue |
| 3 |
| |
| — |
| |
| — |
Total revenue |
| |
| — |
| |
| — | ||
|
|
|
| |||||||
Operating expenses |
|
|
|
| ||||||
Research & development expenses |
|
| ( |
| ( |
| ( |
| ( | |
General & administrative expenses |
|
| ( |
| ( |
| ( |
| ( | |
Other operating income/(expense), net |
|
| |
| |
| |
| | |
Total operating expenses |
| ( |
| ( |
| ( |
| ( | ||
Operating loss |
| ( |
| ( |
| ( |
| ( | ||
Financial income |
| 13 |
| |
| |
| |
| |
Financial expense |
| 13 |
| ( |
| ( |
| ( |
| ( |
Exchange differences, net |
| 13 |
| ( |
| ( |
| ( |
| ( |
Finance result, net |
| ( |
| |
| |
| | ||
Loss before tax |
| ( |
| ( |
| ( |
| ( | ||
Income tax expense |
|
| — |
| ( |
| — |
| ( | |
Loss for the period |
| ( |
| ( |
| ( |
| ( | ||
Loss per share: | 4 |
|
|
|
| |||||
Basic and diluted loss per share for the period attributable to equity holders |
|
| ( |
| ( |
| ( |
| ( | |
Condensed Consolidated Statements of Comprehensive Income/(Loss) (Unaudited)
(In CHF thousands)
For the Three Months | For the Six Months | |||||||||
Ended June 30, | Ended June 30, | |||||||||
| Note |
| 2024 |
| 2023 |
| 2024 |
| 2023 | |
Loss for the period |
| ( |
| ( |
| ( |
| ( | ||
Items that will be reclassified to income or loss in subsequent periods (net of tax): |
|
|
|
| ||||||
Currency translation differences |
| — |
| ( |
| |
| ( | ||
Items that will not to be reclassified to income or loss in subsequent periods (net of tax): |
|
|
|
| ||||||
Remeasurement gains on defined-benefit plans |
|
| — |
| — |
| — |
| — | |
Total comprehensive loss (net of tax) |
| ( |
| ( |
| ( |
| ( | ||
The accompanying notes are an integral part of these Interim Condensed Consolidated Financial Statements (Unaudited).
2
Condensed Consolidated Statements of Changes in Equity (Unaudited)
(In CHF thousands)
|
|
|
|
|
| Currency |
| |||||||
Share | Share | Treasury | Accumulated | translation | ||||||||||
| Note |
| capital |
| premium |
| shares |
| losses |
| differences |
| Total | |
Balance as of January 1, 2023 | | | ( | ( | | | ||||||||
Net loss for the period | — | — | — | ( | — | ( | ||||||||
Other comprehensive loss |
|
| — |
| — |
| — |
| — |
| ( |
| ( | |
Total comprehensive loss |
|
| — |
| — |
| — |
| ( |
| ( |
| ( | |
|
| — |
| — | ||||||||||
Share-based payments |
| — |
| — |
| — |
| |
| — |
| | ||
Proceeds from sale of treasury shares in public offerings, net of underwriting fees and transaction costs |
| — |
| |
| |
| — |
| — |
| | ||
Issuance of shares, net of transaction costs: |
|
|
|
|
|
|
|
|
|
|
|
|
| |
restricted share awards |
|
| |
| |
| — |
| ( |
| — |
| ( | |
exercise of options |
|
| — |
| ( |
| — |
| — |
| — |
| ( | |
Balance as of June 30, 2023 |
|
| |
| |
| ( |
| ( |
| ( |
| |
|
|
|
|
|
| Currency |
| |||||||
Share | Share | Treasury | Accumulated | translation | ||||||||||
| Note |
| capital |
| premium |
| shares |
| losses |
| differences |
| Total | |
Balance as of January 1, 2024 |
| |
| |
| ( |
| ( |
| ( |
| | ||
Net loss for the period |
| — |
| — |
| — |
| ( |
| — |
| ( | ||
Other comprehensive income |
|
| — |
| — |
| — |
| — |
| |
| | |
Total comprehensive income/(loss) |
| — |
| — |
| — |
| ( |
| |
| ( | ||
|
| |||||||||||||
Share-based payments |
| — |
| — |
| — |
| |
| — |
| | ||
Proceeds from sale of treasury shares in public offerings, net of underwriting fees and transaction costs | 12 | — | | | — | — | | |||||||
Issuance of shares to be held as treasury shares | 12 | | — | ( | — | — | — | |||||||
Issuance of shares, net of transaction costs: |
| |||||||||||||
restricted share awards |
| |
| |
| |
| ( |
| — |
| | ||
exercise of options |
| |
| |
| — |
| — |
| — |
| | ||
Balance as of June 30, 2024 |
| |
| |
| ( |
| ( |
| ( |
| |
The accompanying notes are an integral part of these Interim Condensed Consolidated Financial Statements (Unaudited).
3
Condensed Consolidated Statements of Cash Flows (Unaudited)
(In CHF thousands)
For the Six Months | ||||||
Ended June 30, | ||||||
Note | 2024 | 2023 | ||||
Operating activities |
|
|
|
|
|
|
Loss for the period |
| ( |
| ( | ||
Adjustments to reconcile net loss for the period to net cash flows: |
|
| ||||
Depreciation of property, plant and equipment |
| 5 |
| |
| |
Depreciation of right-of-use assets |
| 6 |
| |
| |
Finance (income), net |
|
| |
| ( | |
Share-based compensation expense |
|
| |
| | |
Change in net employee defined benefit liability |
|
| |
| | |
Interest expense |
|
| |
| | |
Changes in working capital: |
|
|
|
| ||
(Increase)/decrease in prepaid expenses |
| 9 |
| |
| ( |
(Increase)/decrease in accrued income |
|
| ( |
| ( | |
(Increase)/decrease in accounts receivable | 11 | | — | |||
(Increase)/decrease in other current receivables |
|
| ( |
| | |
(Decrease)/increase in accrued expenses |
| 7 |
| |
| ( |
(Decrease)/increase in deferred contract revenue, short-term | 3 | | — | |||
(Decrease)/increase in deferred income |
|
| ( |
| ( | |
(Decrease)/increase in trade and other payables |
|
| ( |
| | |
(Decrease)/increase in deferred contract revenue, long-term | 3 | | — | |||
Cash from/(used in) operating activities |
| |
| ( | ||
Interest received |
|
| |
| | |
Interest paid |
|
| ( |
| ( | |
Finance expenses paid |
|
| ( |
| ( | |
Net cash flows from/(used in) operating activities |
| |
| ( | ||
|
|
|
| |||
Investing activities |
|
|
|
| ||
Short-term financial assets, net |
| 10 |
| ( |
| |
Purchases of property, plant and equipment |
| 5 |
| ( |
| ( |
Rental deposits |
| 6 |
| ( |
| — |
Net cash flows (used in)/provided by investing activities |
| ( |
| | ||
|
|
|
| |||
Financing activities |
|
|
|
| ||
Proceeds from sale of treasury shares in public offerings, net of underwriting fees and transaction costs |
| 12 |
| |
| |
Proceeds from issuance of common shares – equity plan, net of transaction costs | | ( | ||||
Transaction costs and stamp duty associated with the public offerings of common shares previously recorded in Accrued expenses | ( | — | ||||
Transaction costs associated with the sale of treasury shares in public offering previously recorded in Accrued expenses | ( | — | ||||
Principal payments of lease obligations | 6 | ( | ( | |||
Net cash flows provided by/(used in) financing activities |
| ( |
| | ||
|
|
|
| |||
Net increase/(decrease) in cash and cash equivalents |
| ( |
| | ||
Cash and cash equivalents at January 1 |
| |
| | ||
Exchange (loss)/gain on cash and cash equivalents |
| ( |
| ( | ||
Cash and cash equivalents at June 30 |
| |
| | ||
Net increase/(decrease) in cash and cash equivalents |
| ( |
| | ||
Supplemental non-cash activity |
|
|
|
| ||
Transaction costs associated with the sale of treasury shares in public offering recorded in Accrued expenses |
| 12 |
| |
| |
The accompanying notes are an integral part of these Interim Condensed Consolidated Financial Statements (Unaudited).
4
Notes to the Interim Condensed Consolidated Financial Statements (Unaudited)
(in CHF thousands, except share and per share amounts)
| 1. | Corporate information |
AC Immune SA was founded in 2003. The Company controls a fully-owned subsidiary, AC Immune USA, Inc. (“AC Immune USA” or “Subsidiary” and, together with AC Immune SA, “AC Immune,” “ACIU,” “Company,” “we,” “our,” “ours,” “us”), which was organized under the laws of Delaware, USA in June 2021. The Company and its Subsidiary form the Group.
AC Immune SA is a clinical-stage biopharmaceutical company leveraging our
The Interim Condensed Consolidated Financial Statements of AC Immune SA as of and for the three and six months ended June 30, 2024 were authorized for issuance by the Company’s Audit and Finance Committee on August 5, 2024.
| 2. | Basis of preparation and changes to the Company’s accounting policies |
Statement of compliance
These Interim Condensed Consolidated Financial Statements as of June 30, 2024 and for the three and six months ended June 30, 2024 and 2023, have been prepared in accordance with International Accounting Standard 34 (IAS 34), Interim Financial Reporting, as issued by the International Accounting Standards Board (IASB), and such financial information should be read in conjunction with the audited consolidated financial statements in AC Immune’s Annual Report on Form 20-F for the year ended December 31, 2023.
Basis of measurement
These Interim Condensed Consolidated Financial Statements have been prepared under the historical cost convention.
Functional and reporting currency
These Interim Condensed Consolidated Financial Statements and accompanying notes are presented in Swiss Francs (CHF), which is AC Immune SA’s functional currency and the Group’s reporting currency. The Company’s subsidiary has a functional currency of the US Dollar (USD). The following exchange rates have been used for the translation of the financial statements of AC Immune USA:
| For the | |||||||||
Three Months Ended June 30, | Six Months Ended June 30, | Year Ended December 31, | ||||||||
2024 |
| 2023 | 2024 |
| 2023 | 2023 | ||||
CHF/USD |
|
|
|
|
|
|
|
|
|
|
Closing rate, USD 1 |
| |
| |
| |
| |
| |
Weighted average exchange rate, USD 1 |
| |
| |
| |
| |
| |
5
Critical judgments and accounting estimates
The preparation of the Company’s Interim Condensed Consolidated Financial Statements in conformity with IAS 34 requires management to make judgments, estimates and assumptions that affect the amounts reported in the Interim Condensed Consolidated Financial Statements and accompanying notes, and the related application of accounting policies as it relates to the reported amounts of assets, liabilities, income and expenses.
The areas where AC Immune has had to make judgments, estimates and assumptions relate to (i) revenue recognition on Licensing and Collaboration Agreements (LCAs), (ii) clinical development accruals, (iii) net employee defined benefit liability, (iv) share-based compensation, (v) right-of-use assets and lease liabilities and (vi) our IPR&D asset (intangible asset). Actual results may differ from these estimates. Estimates and underlying assumptions are reviewed on an ongoing basis. Revisions to accounting estimates are recognized in the period in which the estimates are revised and in any future periods affected.
Fair value of financial assets and liabilities
The Company’s financial assets and liabilities are composed of receivables, short-term financial assets, cash and cash equivalents, trade payables, deferred contract revenue and lease liabilities. The fair value of these financial instruments approximates their respective carrying values due to the short-term maturity of these instruments, and are held at their amortized cost in accordance with IFRS 9, unless otherwise explicitly noted.
Accounting policies, new standards, interpretations and amendments adopted by the Company
The accounting policies adopted in the preparation of the Interim Condensed Consolidated Financial Statements are consistent with those followed in the preparation of the Company’s annual consolidated financial statements for the year ended December 31, 2023.
As of January 1, 2024 the amendments to paragraphs 69 to 76 of IAS 1, Presentation of Financial Statements (IAS 1), as issued by the IASB became effective. The Company assessed the changes to the accounting standard and determined the amendments had an immaterial impact on the Company’s financial statements. There are no other new IFRS standards, amendments or interpretations that are mandatory as of January 1, 2024 that are relevant to the Company. Additionally, in April 2024, the IASB issued IFRS 18 Presentation and Disclosure in Financial Statements (IFRS 18). The new standard on presentation and disclosure in the financial statements will change the structure of the statement of profit or loss, require disclosures for certain profit or loss performance measure that are reported outside of the financial statements, and will enhance principles on aggregation and disaggregation within the notes to the financial statements. This new standard will be effective for annual reporting periods beginning on January 1, 2027 and will require retroactive adoption. The Company is currently evaluating the new standard to determine how it will impact the presentation and disclosure in its financial statements.
Going concern
The Company believes that it will be able to meet all of its obligations as they fall due for at least 12 months from the filing date of this Form 6-K, after considering the Company’s cash position of CHF
To date, the Company has financed its cash requirements primarily from its public offerings, share issuances, contract revenues from its LCAs and grants. The Company is a clinical stage company and is exposed to all the risks inherent to establishing a business. Inherent to the Company’s business are various risks and uncertainties, including the substantial uncertainty as to whether current projects will succeed and our ability to raise additional capital as needed. These risks may require us to take certain measures such as delaying, reducing or eliminating certain programs. The Company’s success may depend in part upon its ability to (i) establish and maintain a strong patent position and protection, (ii) enter into collaborations with partners in the pharmaceutical and biopharmaceutical industries, (iii)
6
successfully move its product candidates through clinical development, (iv) attract and retain key personnel and (v) acquire capital to support its operations.
For the three and six months ended June 30, 2024, AC Immune generated CHF
For the Three Months | ||||
Ended June 30, | ||||
In CHF thousands, unaudited |
| 2024 |
| 2023 |
Takeda |
| |
| — |
Total contract revenue |
| |
| — |
For the Six Months | ||||
Ended June 30, | ||||
In CHF thousands, unaudited |
| 2024 |
| 2023 |
Takeda |
| |
| — |
Total contract revenue |
| |
| — |
3.1Licensing and collaboration agreements
For a discussion of our licensing and collaboration agreements for the fiscal year ended December 31, 2023, please refer to Note 14.1 “Licensing and Collaboration agreements” of our Annual Report on Form 20-F for the year ended December 31, 2023 filed on March 14, 2024.
On January 22, 2024, the Company announced that the development of semorinemab and crenezumab in the collaboration agreements with Genentech, a member of the Roche Group, was terminated. These terminations became effective in April 2024.
Anti-Abeta Active Immunotherapy in AD – 2024 agreement Takeda Pharmaceuticals, USA, Inc.
In May 2024, the Company entered into a worldwide option and license agreement with Takeda Pharmaceuticals, USA, Inc. (Takeda) for our active immunotherapies targeting Abeta, including ACI-24.060 for the treatment of AD. AC Immune will be responsible for completing the ABATE trial. Following option exercise, Takeda would conduct and fund all further clinical development and be responsible for all global regulatory activities as well as worldwide commercialization. Under the terms of the agreement, AC Immune received an upfront payment of USD
Under the terms of the agreement, Takeda may terminate the agreement at any time by providing
AC Immune assessed this arrangement in accordance with IFRS 15 and concluded that Takeda is a customer. The Company identified the following performance obligations under the contract: (i) a license option and (ii) development, chemistry, manufacturing, and controls (“CMC”) and regulatory activities as outlined in the development and CMC plans, which are necessary to deliver the data package to Takeda. AC Immune concluded that the license option is considered a material right, as the value of the license exceeds the option exercise fee, thereby considering it a distinct
7
performance obligation. The development, CMC, and regulatory activities are treated as
At the agreement's execution, the transaction price included only the upfront and non-refundable consideration of USD
The valuation of each performance obligation involves estimates and assumptions, with the timing of revenue recognition determined by either delivery or the provision of services. In line with the allocation objective under IFRS 15, the Company allocated the USD
The Company has deferred revenue recognition for the license option and will recognize the entirety of the revenue either when the option is exercised and Takeda obtains the exclusive license, or when the option expires. 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.
During the three and six months ended June 30, 2024, the Company recorded contract revenue of CHF
3.2Grant income
Grants from the Michael J. Fox Foundation
For a discussion of our Grants from the Michael J. Fox Foundation (MJFF) for the fiscal year ended December 31, 2023, please refer to Note 14.2 “Grant Income” of our Annual Report on Form 20-F for the year ended December 31, 2023 filed on March 14, 2024.
8
For the three months ended June 30, 2024 and 2023, the Company has recognized less than CHF
4.Loss per share
| For the Three Months | |||
Ended June 30, | ||||
In CHF thousands except for share and per share data |
| 2024 |
| 2023 |
Loss per share (EPS) |
|
|
|
|
Numerator |
|
|
|
|
Net loss attributable to equity holders of the Company |
| ( |
| ( |
Denominator |
|
|
|
|
Weighted-average number of shares outstanding used to compute EPS basic and diluted attributable to equity holders |
| |
| |
Basic and diluted loss per share for the period attributable to equity holders |
| ( |
| ( |
For the Six Months | ||||
Ended June 30, | ||||
In CHF thousands except for share and per share data |
| 2024 | 2023 | |
Loss per share (EPS) |
|
|
| |
Numerator |
|
|
| |
Net loss attributable to equity holders of the Company | ( |
| ( | |
Denominator |
| |||
Weighted-average number of shares outstanding used to compute EPS basic and diluted attributable to equity holders | |
| | |
Basic and diluted loss per share for the period attributable to equity holders | ( |
| ( | |
The weighted-average number of potentially dilutive securities that were not included in the diluted per share calculations because they would be anti-dilutive were as follows:
| For the Three Months | |||
Ended June 30, | ||||
| 2024 |
| 2023 | |
Share options issued and outstanding |
| |
| |
Restricted share awards subject to future vesting |
| |
| |
For the Six Months | ||||
Ended June 30, | ||||
2024 | 2023 | |||
Share options issued and outstanding |
| |
| |
Restricted share awards subject to future vesting |
| |
| |
9
5.Property, plant and equipment
The following table shows the movement in the net book values of property, plant and equipment for the six months ended June 30, 2024:
| As of June 30, 2024 | |||||||||||
| IT |
| Lab |
| Leasehold |
| Assets under |
| ||||
In CHF thousands | Furniture | equipment | equipment | improvements | construction | Total | ||||||
Acquisition cost: |
|
|
|
|
|
|
|
|
|
|
|
|
Balance at December 31, 2023 |
| |
| |
| |
| |
| — |
| |
Additions |
| |
| |
| |
| |
| — |
| |
Balance at June 30, 2024 |
| |
| |
| |
| |
| — |
| |
Accumulated depreciation: |
|
|
|
|
|
| ||||||
Balance at December 31, 2023 |
| ( |
| ( |
| ( |
| ( |
| — |
| ( |
Depreciation expense |
| ( |
| ( |
| ( |
| ( |
| — |
| ( |
Balance at June 30, 2024 |
| ( |
| ( |
| ( |
| ( |
| — |
| ( |
Carrying amount: |
|
|
|
|
|
|
|
|
|
|
| |
December 31, 2023 |
| |
| |
| |
| |
| — |
| |
June 30, 2024 |
| |
| |
| |
| |
| — |
| |
6.Right-of-use assets, long-term financial assets and lease liabilities
AC Immune recognized additions of less than CHF
Regarding lease liabilities, the amortization depends on the rate implicit in the contract or the incremental borrowing rate for the respective lease component. The weighted averages of the incremental borrowing rates are
The following table shows the movements in the net book values of right-of-use of leased assets for the six months ended June 30, 2024:
|
| Office |
| IT |
| |||
In CHF thousands | Buildings | equipment | equipment | Total | ||||
Balance as of December 31, 2023 |
| |
| |
| |
| |
Additions and remeasurements |
| — |
| |
| — |
| |
Depreciation |
| ( |
| ( |
| ( |
| ( |
Balance as of June 30, 2024 |
| |
| |
| |
| |
There are
10
For the three and six months ended June 30, 2024, and 2023, the impact on the Company’s condensed consolidated statements of income/(loss) and the condensed consolidated statements of cash flows is as follows:
For the Three Months | ||||
Ended June 30, | ||||
In CHF thousands |
| 2024 |
| 2023 |
Statements of income/(loss) |
|
|
|
|
Depreciation of right-of-use assets |
|
| ||
Interest expense on lease liabilities |
|
| ||
Expense for short-term leases and leases of low value |
|
| ||
Total |
|
| ||
Statements of cash flows |
|
|
| |
Total cash outflow for leases |
|
| ||
For the Six Months | ||||
Ended June 30, | ||||
In CHF thousands |
| 2024 |
| 2023 |
Statements of income/(loss) |
|
|
|
|
Depreciation of right-of-use assets |
|
| ||
Interest expense on lease liabilities |
|
| ||
Expense for short-term leases and leases of low value |
|
| ||
Total |
|
| ||
Statements of cash flows |
|
|
| |
Total cash outflow for leases |
|
| ||
The following table presents the contractual undiscounted cash flows for lease obligations as of June 30, 2024:
As of | ||
In CHF thousands |
| June 30, 2024 |
Less than one year |
| |
1-3 years |
| |
3-5 years |
| |
Total |
| |
The Company also has deposits in escrow accounts totaling CHF
7.Accrued expenses
| As of | |||
In CHF thousands | June 30, 2024 | December 31, 2023 | ||
Accrued expenses |
| |
| |
Total accrued expenses |
| |
| |
Accrued expenses consists of accrued R&D costs, accrued payroll expenses and other accrued expenses totaling CHF
11
8.Intangible assets
AC Immune’s acquired IPR&D asset is a clinically-validated active vaccine candidate for the treatment of Parkinson’s disease. The asset is not yet ready for use until the asset obtains market approval and is therefore not currently being amortized. The carrying amount and net book value are detailed below:
| As of June 30, 2024 | As of December 31, 2023 | ||||||||||
| Gross |
|
|
| Gross |
|
| |||||
Carrying | Accumulated | Net Book | Carrying | Accumulated | Net Book | |||||||
In CHF thousands | Amount | Amortization | Value | Amount | Amortization | Value | ||||||
Acquired IPR&D asset | |
| — |
| |
| |
| — |
| | |
Total intangible assets | |
| — |
| |
| |
| — |
| | |
In accordance with IAS 36 Impairment of Assets, the IPR&D asset is reviewed at least annually for impairment by assessing the fair value less costs to sell (recoverable amount) and comparing this to the carrying value of the asset. The valuation is considered to be Level 3 in the fair value hierarchy in accordance with IFRS 13 Fair Value Measurement due to unobservable inputs used in the valuation. The Company has determined the IPR&D asset not to be impaired as of December 31, 2023. As of June 30, 2024, the Company did not identify any triggering events that could result in an impairment of the IPR&D asset.
9.Prepaid expenses
Prepaid expenses include prepaid R&D costs, administrative costs and employee social obligations totaling CHF
10.Cash and cash equivalents and short-term financial assets
The following table summarizes AC Immune’s cash and cash equivalents and short-term financial assets as of June 30, 2024 and December 31, 2023:
| As of | |||
In CHF thousands | June 30, 2024 |
| December 31, 2023 | |
Cash and cash equivalents |
|
| ||
Total cash and cash equivalents |
|
| ||
| As of | |||
In CHF thousands | June 30, 2024 |
| December 31, 2023 | |
Short-term financial assets due in one year or less |
| |
| |
Total short-term financial assets |
| |
| |
For the six months ended June 30, 2024, the net investments associated with the short-term financial assets amounted to CHF
12
11.Accounts receivable
As of June 30, 2024, the balance of accounts receivable is
12.Share capital and Treasury shares
For a discussion of our at the market offering program with Jefferies LLC for the fiscal year ended December 31, 2023, please refer to Note 12 “Share capital” of our Annual Report on Form 20-F for the year ended December 31, 2023 filed on March 14, 2024.
In Q2 2024, the Company issued
In Q2 2024, the Company sold
As of June 30, 2024 and December 31, 2023, the Company had
13.Finance result, net
For the three months ended June 30, 2024 and 2023, the net finance result amounted to a loss of CHF
For the six months ended June 30, 2024 and 2023, AC Immune recorded CHF
14.Subsequent events
Management has evaluated subsequent events after the balance sheet date, through the issuance of these Interim Condensed Consolidated Financial Statements, for appropriate accounting and disclosures. The Company has determined that there were no other such events that warrant disclosure or recognition in these Interim Condensed Consolidated Financial Statements.
13
Exhibit 99.2
MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION
AND RESULTS OF OPERATIONS
This management’s discussion and analysis is designed to provide you with a narrative explanation of our financial condition and results of operations. We recommend that you read this in conjunction with our unaudited interim condensed consolidated financial information as of and for the three and six months ended June 30, 2024, included as Exhibit 99.1 to this Report on Form 6-K. We also recommend that you read our management’s discussion and analysis and our audited consolidated financial statements and the notes thereto, which appear in our Annual Report on Form 20-F for the year ended December 31, 2023 on file with the U.S. Securities and Exchange Commission (the “SEC”).
Unless otherwise indicated or the context otherwise requires, the terms “Company,” “AC Immune,” “ACIU,” “we,” “our,” “ours,” or “us” refer to AC Immune SA together with its fully-owned subsidiary, AC Immune USA, Inc.
We prepare and report our consolidated financial statements and financial information in accordance with International Financial Reporting Standards (IFRS) as issued by the International Accounting Standards Board (IASB). None of our consolidated financial statements were prepared in accordance with generally accepted accounting principles in the United States. We maintain our books and records in Swiss Francs (CHF). We have made rounding adjustments to some of the figures included in this management’s discussion and analysis. Accordingly, numerical figures shown as totals in some tables may not be an arithmetic aggregation of the figures that precede them. Unless otherwise indicated, all references to currency amounts in this discussion and analysis are in Swiss Francs.
This discussion and analysis is dated as of August 6, 2024.
Business Overview
Our goal is to continue leveraging our proprietary discovery platforms, SupraAntigen and Morphomer, to shift the treatment paradigm for neurodegenerative diseases towards Precision Medicine and disease prevention. We are executing a clear business strategy built on three pillars: (i) accelerate development of novel therapeutics in Alzheimer’s disease (AD) with our partners; (ii) expand our strategic focus on Parkinson’ disease (PD) and non-AD neurodegenerative diseases, including NeuroOrphan indications; and (iii) a continued focus on diagnostics enabling Precision Medicine to be an ultimate differentiator for the Company.
Our three-pillar execution strategy reflects our unique Precision Medicine approach, which ultimately creates differentiation due to our ability to address the high levels of co-pathologies present in AD and other neurodegenerative diseases. Much like cancer, neurodegenerative diseases are heterogeneous and may require multiple therapeutic interventions tailored to patients’ specific disease drivers, to be used in combination in order to slow or stop the disease course. 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.
Leveraging our dual proprietary technology platforms, SupraAntigen and Morphomer, we have built a comprehensive pipeline of first-in-class or best-in-class candidates spanning multiple treatment modalities and targeting both established and emerging neurodegenerative pathologies. We are currently advancing numerous therapeutic and diagnostic programs, including one in a Phase 3 clinical trial and three in Phase 2 clinical trials, targeting five different types of misfolded pathological proteins related to AD, PD and other neurodegenerative disorders. Our pipeline assets are further validated by the multiple partnerships we have established with leading global pharmaceutical companies. We believe our clinically validated technology platforms and multi-target, multimodal approach position AC Immune to revolutionize the treatment of neurodegenerative diseases by shifting the paradigm towards Precision Medicine and disease prevention.
Our clinical-stage product candidates include:
| ● | ACI-24.060 for AD and for AD in DS. ACI-24.060 is an enhanced formulation of an earlier version of ACI-24 which incorporates Abeta-unrelated T-helper cell epitopes to increase the magnitude and the boostability of the antibody response against pathologic Abeta. ACI-24.060 is currently being tested at 3 different incremental doses in the ABATE Phase 1b/2 trial (NCT05462106) and amyloid plaque reduction is being assessed using Abeta-PET imaging. |
ABATE is a multicenter, adaptive, double-blind, randomized, placebo-controlled study designed to assess the safety, tolerability, immunogenicity, and pharmacodynamic effects of ACl-24.060 in subjects with prodromal AD and in adults with Down Syndrome (DS). The Clinical Trial Application (CTA) was approved by the UK Medicines and Healthcare Products Regulatory Agency (MHRA) and Spanish Agency for Medicines and Health Products (AEMPS) with the first AD patient dosed in June 2022. In June 2023, AC Immune received Fast Track designation from the FDA for ACI-24.060, for the treatment of AD. This followed FDA clearance of the Investigational New Drug (IND) application in May 2023 enabling the ABATE study to include clinical trial sites to enroll participants with DS in the U.S. Based on the safety profile and induction of an anti-Abeta antibody response post-dosing of ACI-24.060 in patients with AD, dosing of the first individual with DS occurred in June 2023.
As announced on May 13, 2024, this program is the subject of an exclusive option and license agreement with Takeda Pharmaceuticals USA, Inc. (Takeda). 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 range and potential development, commercial and sales-based milestone payments. Upon commercialization, AC Immune will be entitled to receive tiered mid-to-high teens percentages royalties on worldwide net sales. Further details related to the agreement are available on the Current Report on Form 6-K furnished by the Company on May 13, 2024 with the SEC.
| ● | ACI-7104.056. ACI-7104.056, the optimized formulation of the clinically-validated PD anti-a-syn active immunotherapy PD01A, 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. 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 enrollment of cohort 1 was completed in December 2023, with 16 patients randomized. No safety concerns have been reported to date. |
| ● | ACI-35.030 (JNJ-64042056). AC Immune and Janssen Pharmaceuticals, Inc. (Janssen), part of the Janssen Pharmaceutical Companies of Johnson & Johnson, evaluated the anti-phosphorylated-Tau (anti-pTau) active immunotherapy ACI-35.030 in a Phase 1b/2a study in subjects with early AD (NCT04445831). Results showed that ACI-35.030 immunization generated a rapid antibody response (anti-pTau, anti-ePHF and anti-Tau IgG) after the first injection (at week 2) at the 3 tested doses. An apparent dose-effect was observed between low- and mid-doses but not between the mid- and high-doses. A boosting effect was observed after each injection especially against pathological Tau species (pTau and ePHF). The antibody response was strongly directed against pathological Tau species but not against non-phosphorylated Tau. Long-term maintenance of the anti-ePHF IgG titers against endogenous pathological Tau was observed at the mid- and high-dose. |
In addition to ACI-35.030, an exploratory alternative anti-pTau active immunotherapy candidate, JACI-35.054, was also evaluated in the same Phase 1b/2a trial. It generated a more varied antibody response (anti-pTau, anti-ePHF and anti-Tau IgG) after the second injection (at week 10) at the 2 tested doses. While there was no apparent dose-effect between the 2 tested doses, a higher variability of titers was observed at the low dose. A boosting effect was seen against both pathological Tau and non-phosphorylated Tau species from the 2nd injection. For JACI-35.054, there was a lower extent of specific antibody response against pathological Tau species compared to non-phosphorylated Tau as observed with ACI-35.030. Both ACI-35.030 and JACI-35.054 showed good safety and tolerability profiles. The majority of adverse events (AEs) were of mild intensity. No deaths were reported. No AE led to study discontinuation or to study treatment discontinuation. Injection site
2
reactions were the most frequently reported AEs in actively treated subjects. Serious adverse events (SAEs) observed in subjects treated with ACI-35.030 did not appear to have any particular relationship to the dose.
Consequently, ACI-35.030, targeting pathological phosphorylated Tau (pTau), is being advanced and will be assessed in subjects with preclinical (i.e., pre-symptomatic) AD in a Phase 2b study in which the first patient will be dosed imminently. 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 interim analyses potentially allowing for acceleration towards a regulatory filing. AC Immune’s ACI-35.030 was granted Fast Track designation from the FDA, for the treatment of AD in July 2024.
| ● | PI-2620. PI-2620 is the Tau-PET imaging agent discovered during the collaboration of AC Immune and Life Molecular Imaging (LMI). We are working with our partner, LMI, to advance PI-2620 as a highly differentiated, best-in-class Tau diagnostic for AD as well as non-AD Tauopathies such as progressive supranuclear palsy (PSP) and corticobasal degeneration (CBD). Results have demonstrated PI-2620’s differentiated characteristics as a diagnostic tool for studying Tau-related diseases. Results on the use of PI-2620 in AD patients from an investigator sponsored Phase 2 trial at the Asan Medical Center (NCT03903211) were presented at the 2022 AAIC. Following these results, LMI moved PI-2620 into late-stage clinical development in AD and made a milestone payment. The first Alzheimer’s patient in ADvance, the pivotal Phase 3 histopathology study in AD (NCT05641688), was imaged in January 2023. |
| ● | ACI-12589. Our Morphomer platform has delivered the first clinically validated a-syn-PET tracer which now can support the differential diagnosis of multiple system atrophy (MSA) from other neurodegenerative disease and allow precision medicine approaches and biomarker-based clinical development in this indication. ACI-12589 preclinical and clinical data were published in October 2023 in Nature Communications. In addition, medicinal chemistry optimization strategies have allowed the identification of our next-generation clinical candidate, ACI-15916. Compared to ACI-12589, ACI-15916 shows significantly higher target occupancy in brain slices from idiopathic forms of PD and has therefore the potential to enable imaging of a-syn pathology in patients with PD. IND/CTA-enabling studies for ACI-15196 were initiated in Q1 2024 with the regulatory submission planned in Q4 2024. |
| ● | Morphomer Tau aggregation inhibitors. In collaboration with our partner, Lilly, we are researching and developing small molecule Tau aggregation inhibitors with plans to evaluate candidates in AD and NeuroOrphan Tauopathies. Continued candidate characterization across the research program has also identified new and highly differentiated candidates with excellent cerebrospinal fluid exposure and selectivity for pathological aggregated Tau. |
| ● | Semorinemab. Semorinemab is an investigational monoclonal anti-Tau antibody that targets the N-terminal portion of the Tau protein and is designed to bind to Tau and slow its spread between neurons for the treatment of AD. As announced on January 22, 2024, the development of semorinemab in the collaboration agreement with Genentech, a member of the Roche Group, was terminated. This termination became effective in April 2024. Semorinemab has been studied in two Phase 2 studies: Tauriel in early (prodromal-to-mild) AD, where the primary efficacy endpoint was not met; and Lauriet in mild-to-moderate AD. In Lauriet, a strongly positive and highly statistically significant effect was seen on ADAS-Cog11 (one of two co-primary endpoints) plus statistically significant effects on several key biomarkers, including total Tau and pTau217 in CSF and plasma. The second co-primary endpoint, ADCS-ADL, and the secondary efficacy endpoints did not reach significance. Final open label extension results from the Lauriet trial will be reviewed when they become available and are received in full by AC Immune. The Company will then carefully review and evaluate available data sets, before decisions are made on potential further development and other opportunities. |
| ● | Crenezumab. Crenezumab is a humanized monoclonal antibody, an investigational treatment designed to slow AD progression by neutralizing neurotoxic Abeta oligomers. It was designed by AC Immune to be a conformation-specific monoclonal antibody targeting multiple forms of misfolded Abeta. As announced on January 22, 2024, the development of crenezumab in the collaboration agreement with Genentech, a member of the Roche Group, was terminated. This termination became effective in April 2024. Crenezumab has an antibody backbone (IgG4) designed to minimize the inflammatory response in the brain, which may result in a lower incidence of side effects known as ARIA (Amyloid-Related Imaging Abnormalities). The investigational |
3
| medicine has demonstrated excellent safety (e.g. less than 1% of ARIA-E cases in the Phase 3 studies; Ostrowitzki et al., JAMA Neurology, 2022) and encouraging efficacy signals while undergoing extensive Phase 2 clinical testing. While the Colombian autosomal-dominant AD prevention trial was not sufficiently powered to show significant cognitive benefits, crenezumab was proven to be safe with numeric trends on the primary and vast majority of secondary and exploratory endpoints in its favor. The lessons from this study provided useful insights regarding the desired anti-amyloid immunotherapy profile and designs for prevention trials. AC Immune will carefully review and evaluate available data sets, before decisions are made on potential further development and other opportunities. |
Interim 2024 Company Highlights
| ● | AC Immune and Takeda signed an exclusive option and license agreement for AC Immune’s active immunotherapies targeting Abeta, including ACI-24.060 for AD. Under the terms of the agreement, AC Immune received an upfront payment of USD 100.0 (CHF 92.3) million from Takeda and, if all related milestones are achieved over the course of the agreement, is eligible to receive payments of up to approximately USD 2.1 (CHF 1.9) billion including an option exercise fee and additional potential development, commercial and sales-based milestones. Upon commercialization, AC Immune will be entitled to receive tiered double-digit royalties on worldwide net sales. |
| ● | Enrolment in the ACI-24.060 ABATE Phase 2 AD trial continues. |
| ● | We also completed the regulatory toxicology studies for the anti-TDP-43 monoclonal antibody candidate in Q2 which will enable us to proceed with IND filing. |
| ● | Our targeted NLRP3 inhibitor candidates continue to show excellent promise in preclinical results featured at the AD/PD™ 2024 conference: |
| o | ACI-19764 is a brain penetrant small molecule in preclinical development that directly binds and inhibits NLRP3. Its activity in vitro and in vivo was demonstrated in two models of neuroinflammation. In addition, ACI-19764 demonstrated an excellent safety profile and optimal exposure for sustained NLRP3 inhibition in the brain. |
| o | AC Immune intends to file an IND from the NLRP3 program in the near future. |
| ● | AC Immune’s preclinical programs were featured in multiple presentations at the Alzheimer’s Association International Conference (AAIC) 2024: |
| o | A new class of neurodegenerative disease-fighting drugs: morADC (Morphomer®- antibody drug conjugates), presented by Madiha Derouazi (Chief Scientific Officer, AC Immune), featured data from AC Immune’s proprietary morADC platform. Results demonstrated the ability of morADCs to penetrate the blood brain barrier in vivo and produce potent catalytic activity in vitro compared to the parental monoclonal antibody or small molecule alone. |
| o | Active immunotherapy, ACI-24.060, induces anti-Abeta antibodies with binding profiles mirroring clinically validated monoclonal antibodies, presented by Emma Fiorini (AC Immune), featured results from non-human primates demonstrating that ACI-24.060 induced antibody responses in a similar range of levels of donanemab and lecanemab and with preferential oligomeric Abeta binding as compared to monomeric Abeta. |
| o | Discovery and preclinical development of [18F]ACI-19626, a first-in-class TDP-43 PET tracer, presented by Tamara Seredenina (AC Immune), described the selection of [18F]ACI-19626 for evaluation as a potential PET tracer for detection and monitoring progression of TDP-43 aggregates based on its favorable affinity, selectivity and pharmacokinetic properties. |
| ● | Board and Management Share Purchases: Members of the Board of Directors and certain members of executive management purchased shares in AC Immune SA during Q2 2024, following the announcement of the exclusive option and license agreement with Takeda for ACI-24.060. As a foreign private issuer (FPI), individual shareholdings will be disclosed in the Annual Report on Form 20-F. |
4
Results of Operations
Comparison of the three and six months ended June 30, 2024 and 2023
Contract revenues
The Company generated CHF 0.7 million in contract revenues for the three months ended June 30, 2024, compared to nil in the comparable prior period. This represents an increase of CHF 0.7 million. The following table summarizes our contact revenues during the three months ended June 30, 2024 and 2023:
| | For the Three Months | ||
| | Ended June 30, | ||
In CHF thousands, unaudited |
| 2024 |
| 2023 |
Takeda |
| 687 |
| — |
Total contract revenue |
| 687 |
| — |
For the three months ended June 30, 2024, the increase of CHF 0.7 million compared with the prior period is due to the efforts made under the agreement with Takeda.
For the six months ended June 30, 2024, the Company generated CHF 0.7 million in contract revenues compared to nil in the comparable period. This represents an increase of CHF 0.7 million. The following table summarizes our contact revenues during the six months ended June 30, 2024 and 2023:
| | For the Six Months | ||
| | Ended June 30, | ||
In CHF thousands, unaudited |
| 2024 |
| 2023 |
Takeda |
| 687 |
| — |
Total contract revenue |
| 687 |
| — |
For the six months ended June 30, 2024, the increase of CHF 0.7 million compared with the prior period is due to the efforts made under the agreement with Takeda.
Research and development expenses
Research and development (R&D) 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. Our collaboration agreements have different arrangements 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. 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 clinical development, manufacturing and commercialization.
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.
Finally, we intend to further advance the characterization of our other clinical and preclinical candidates, such as our Morphomer Tau program. In addition to the collaborative arrangements and proprietarily held assets, we expect that our total future R&D costs will increase over current levels, in line with our three-pillar strategy that focuses on (i) AD, (ii) expansion in PD and non-AD neurodegenerative diseases, including NeuroOrphan indications and (iii) diagnostics.
The table below provides a breakdown of our R&D costs, including direct R&D costs, manufacturing costs related to R&D and other R&D costs not allocated directly to programs for the periods covered by these Interim Condensed Consolidated Financial Statements. The R&D costs not allocated to specific programs include employment costs,
5
regulatory, quality assurance and intellectual property costs. We do not assign our internal costs, such as salary and benefits, share-based compensation expenses, laboratory supplies, and other direct expenses and infrastructure costs to individual R&D projects, because the employees within our R&D groups are typically deployed across multiple R&D programs.
For the three months ended June 30, 2024, R&D expenses totaled CHF 17.1 million compared with CHF 13.7 million for the comparable period in 2023. This represents an increase of CHF 3.4 million. The following table presents the R&D expenses during the three months ended June 30, 2024 and 2023:
|
| For the Three Months |
|
| ||
| | Ended June 30, | | | ||
In CHF thousands, unaudited |
| 2024 |
| 2023 |
| Change |
Discovery and preclinical expenses |
| 2,743 |
| 2,283 |
| 460 |
Clinical expenses |
| 5,884 |
| 3,159 |
| 2,725 |
Group function expenses |
| 586 |
| 317 |
| 269 |
Total direct R&D expenses |
| 9,213 |
| 5,759 |
| 3,454 |
Payroll expenses |
| 5,035 |
| 5,077 |
| (42) |
Share-based compensation |
| 608 |
| 559 |
| 49 |
Other non-allocated |
| 2,282 |
| 2,287 |
| (5) |
Total R&D expenses |
| 17,138 |
| 13,682 |
| 3,456 |
|
| For the Three Months |
|
| ||
| | Ended June 30, | | | ||
In CHF thousands, unaudited | | 2024 | | 2023 | | Change |
Operating expenses1 |
| 11,495 |
| 8,046 |
| 3,449 |
Salaries and related costs2 |
| 5,643 |
| 5,636 |
| 7 |
Total R&D expenses |
| 17,138 |
| 13,682 |
| 3,456 |
1 | Includes depreciation expense |
2 | Includes share-based compensation expense |
For the three months ended June 30, 2024:
Discovery and preclinical expenses increased by CHF 0.5 million, primarily due to:
| ● | an increase in ACI-24.060 of CHF 0.3 million due to ongoing preclinical activities, which had not started in the prior comparative period. |
Clinical expenses increased by CHF 2.7 million, primarily due to:
| ● | an increase of CHF 1.4 million attributed to the ramp-up of activities for our Phase 2 VacSYn study evaluating ACI-7104.056 in early PD and CHF 1.3 million in our ACI-24.060 active immunotherapy for expansion of the ABATE study. |
The variances in Group function expenses are related to regulatory and quality assurance, and intellectual property costs.
Other non-allocated expenses are related to infrastructure and functional expenses not allocated to direct R&D expenses.
6
For the six months ended June 30, 2024, R&D expenses totaled CHF 32.3 million compared with CHF 27.6 million for the comparable period in 2023. This represents an increase of CHF 4.7 million. The following table presents the R&D expenses during the six months ended June 30, 2024 and 2023:
|
| For the Six Months |
| | ||
| | Ended June 30, | | | ||
In CHF thousands, unaudited | | 2024 | | 2023 | | Change |
Discovery and preclinical expenses |
| 4,980 |
| 4,756 |
| 224 |
Clinical expenses |
| 10,583 |
| 5,898 |
| 4,685 |
Group function expenses |
| 948 |
| 785 |
| 163 |
Total direct R&D expenses |
| 16,511 |
| 11,439 |
| 5,072 |
Payroll expenses |
| 10,163 |
| 9,973 |
| 190 |
Share-based compensation |
| 1,247 |
| 1,217 |
| 30 |
Other non-allocated |
| 4,382 |
| 4,926 |
| (544) |
Total R&D expenses |
| 32,303 |
| 27,555 |
| 4,748 |
| | For the Six Months | | | ||
| | Ended June 30, | | | ||
In CHF thousands, unaudited | | 2024 | | 2023 | | Change |
Operating expenses1 |
| 20,893 |
| 16,365 |
| 4,528 |
Salaries and related costs2 |
| 11,410 |
| 11,190 |
| 220 |
Total R&D expenses |
| 32,303 |
| 27,555 |
| 4,748 |
1 | Includes depreciation expense |
2 | Includes share-based compensation expense |
For the six months ended June 30, 2024:
Clinical expenses increased by CHF 4.7 million, primarily due to:
| ● | an increase of CHF 3.0 million in our ACI-24.060 active immunotherapy for expansion of the ABATE study and CHF 1.7 million attributed to the ramp-up of activities for our Phase 2 VacSYn study evaluating ACI-7104.056 in early PD. |
The variances in Group function expenses are related to regulatory and quality assurance, and intellectual property costs.
Other non-allocated expenses are related to infrastructure and functional expenses not allocated to direct R&D expenses.
General and administrative expenses
General and administrative expenses consist 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 three months ended June 30, 2024, general and administrative expenses totaled CHF 4.6 million compared with CHF 3.7 million for the comparable period in 2023. This represents an increase of CHF 0.9 million. The following table presents the general and administrative expenses during the three months ended June 30, 2024 and 2023:
|
| For the Three Months |
|
| ||
| | Ended June 30, | | | ||
In CHF thousands, unaudited | | 2024 |
| 2023 |
| Change |
Operating expenses1 |
| 1,462 |
| 993 |
| 469 |
Salaries and related costs2 |
| 3,089 |
| 2,688 |
| 401 |
Total general and administrative expenses |
| 4,551 |
| 3,681 |
| 870 |
1 | Includes depreciation expense |
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2 | Includes share-based compensation expense |
For the three months ended June 30, 2024, this increase is primarily due to:
| ● | an increase of CHF 0.5 million in operating expenses, predominantly due to a rise of CHF 0.4 million in legal fees related to business development and licensing activities. |
| ● | an increase of CHF 0.4 million in salaries and related costs, largely attributable to the higher expenses from equity awards granted in 2024, which have a higher fair value. |
For the six months ended June 30, 2024, general and administrative expenses totaled CHF 9.5 million compared with CHF 7.8 million for the comparable period in 2023. This represents an increase of CHF 1.7 million. The following table presents the general and administrative expenses during the six months ended June 30, 2024 and 2023:
|
| For the Six Months |
|
| ||
| | Ended June 30, | | | ||
In CHF thousands, unaudited | | 2024 | | 2023 | | Change |
Operating expenses1 |
| 3,377 |
| 2,271 |
| 1,106 |
Salaries and related costs2 |
| 6,145 |
| 5,516 |
| 629 |
Total general and administrative expenses |
| 9,522 |
| 7,787 |
| 1,735 |
1 | Includes depreciation expense |
2 | Includes share-based compensation expense |
For the six months ended June 30, 2024, this increase is primarily due to:
| ● | an increase of CHF 1.1 million in operating expenses, predominantly due to a rise of CHF 0.9 million in legal fees related to business development and licensing activities. |
| ● | an increase of CHF 0.6 million in salaries and related costs, largely attributable to the higher expenses from equity awards granted in 2024, which have a higher fair value. |
Other operating income/(expense), net
Other operating income/(expense), net consists primarily of income associated with foundation grants such as those from the MJFF or Target ALS.
For the three months ended June 30, 2024, other operating income/(expense), net totaled less than CHF 0.1 million compared with CHF 0.3 million for the comparable period in 2023. This represents a decrease of CHF 0.3 million. The following table presents the other operating income/(expense), net during the three months ended June 30, 2024 and 2023:
|
| For the Three Months |
|
| ||
| | Ended June 30, | | | ||
In CHF thousands, unaudited | | 2024 |
| 2023 |
| Change |
Other operating income/(expense), net |
| 41 |
| 317 |
| (276) |
Total other operating income/(expense), net |
| 41 |
| 317 |
| (276) |
For the three months ended June 30, 2024, the decrease of CHF 0.3 million in grant income primarily resulted from activities related to our MJFF awards that were completed prior to the start of the current period.
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For the six months ended June 30, 2024, other operating income/(expense), net totaled CHF 0.1 million compared with CHF 0.7 million for the comparable period in 2023. This represents a decrease of CHF 0.6 million. The following table presents the other operating income/(expense), net during the six months ended June 30, 2024 and 2023:
| | For the Six Months | | | ||
| | Ended June 30, | | | ||
In CHF thousands, unaudited |
| 2024 |
| 2023 |
| Change |
Other operating income/(expense), net |
| 109 |
| 725 |
| (616) |
Total other operating income/(expense), net |
| 109 |
| 725 |
| (616) |
For the six months ended June 30, 2024, the decrease of CHF 0.6 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 three months ended June 30, 2024, net finance result was a CHF 1.8 million loss compared with a CHF 0.2 million gain for the comparable period in 2023. This represents a decrease of CHF 2.0 million. The following table presents the net finance result during the three months ended June 30, 2024 and 2023:
|
| For the Three Months |
|
| ||
| | Ended June 30, | | | ||
In CHF thousands, unaudited | | 2024 |
| 2023 |
| Change |
Financial income |
| 739 |
| 259 |
| 480 |
Financial expense |
| (34) |
| (27) |
| (7) |
Exchange differences, net |
| (2,504) |
| (16) |
| (2,488) |
Finance result, net |
| (1,799) |
| 216 |
| (2,015) |
For the three months ended June 30, 2024, the change in net finance result of CHF 2.0 million primarily related to:
| ● | a loss of CHF 2.5 million explained by unfavorable foreign currency exchange differences related to movement in the CHF versus foreign currencies, predominantly the US Dollar. |
This was partially offset by:
| ● | an increase of CHF 0.5 million in financial income due to higher interest received on net investments in short-term financial assets, attributed to more deposits in 2024 compared to the prior period. |
For the six months ended June 30, 2024, net finance result was a CHF 0.4 million gain compared with a CHF 0.3 million gain for the comparable period in 2023. This represents an increase of CHF 0.1 million. The following table presents the net finance result during the six months ended June 30, 2024 and 2023:
| | For the Six Months | | | ||
| | Ended June 30, | | | ||
In CHF thousands, unaudited | | 2024 | | 2023 | | Change |
Financial income |
| 1,368 |
| 468 |
| 900 |
Financial expense |
| (70) |
| (124) |
| 54 |
Exchange differences, net |
| (891) |
| (67) |
| (824) |
Finance result, net |
| 407 |
| 277 |
| 130 |
For the six months ended June 30, 2024, the increase of CHF 0.1 million in finance result, net primarily related to:
| ● | an increase of CHF 0.9 million in financial income due to higher interest received on net investments in short-term financial assets, attributed to more deposits in 2024 compared to the prior period. |
This was partially offset by:
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| ● | a loss of CHF 0.9 million explained by unfavorable foreign currency exchange differences related to movement in the CHF versus foreign currencies, predominantly the US Dollar. |
Liquidity and Capital Resources
To date, the Company has financed its cash requirements primarily from its public offerings, share issuances, contract revenues from license and collaboration agreements (LCAs) and grants. The Company is a clinical stage company and is exposed to all the risks inherent to establishing a business. Inherent to the Company’s business are various risks and uncertainties, including the substantial uncertainty as to whether current projects will succeed and our ability to raise additional capital as needed. These risks may require us to take certain measures such as delaying, reducing or eliminating certain programs. The Company’s success may depend in part upon its ability to (i) establish and maintain a strong patent position and protection, (ii) enter into collaborations with partners in the pharmaceutical and biopharmaceutical industries, (iii) successfully move its product candidates through clinical development, (iv) attract and retain key personnel and (v) acquire capital to support its operations. As of June 30, 2024, we had cash and cash equivalents of CHF 51.6 million and short-term financial assets of CHF 123.6 million for a total liquidity balance of CHF 175.2 million.
Our primary uses of capital are, and we expect will continue to be, R&D expenses, compensation and related expenses and other operating expenses including rent. Cash and cash equivalents used to fund operating expenses are impacted by the timing of when we pay expenses, as reflected in the change in our outstanding trade and other payables and accrued expenses. We expect to incur substantial expenses in connection with our product candidates in various stages of clinical development. We and Janssen have completed the co-development of the second-generation lead active immunotherapies, ACI-35.030 and JACI-35.054, through Phase 1b/2a. In November 2022, it was announced that ACI-35.030 was selected to advance into further development based on interim data from the ongoing Phase 1b/2a trial. In December 2023, it was announced that Janssen has programmed the launch of a Phase 2b clinical study to evaluate ACI-35.030 (JNJ-64042056) in patients with preclinical AD, those individuals not yet showing symptoms. AC Immune and Janssen will jointly share research and development costs until the completion of 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 of ACI-35.030. We intend to increase our R&D costs associated with the advancement of the active immunotherapies, ACI-24.060 targeting Abeta in AD and AD in DS and ACI-7104.056 targeting a-syn in PD, through clinical development, as well as through investments in our diagnostic programs.
We plan to continue to fund our operating and capital funding needs through proceeds received from licensing and collaboration agreements (LCAs) and through equity or other forms of financing. For example, in Q3 2020 we entered into the Open Market Sale Agreement (Sale Agreement) with Jefferies LLC (Jefferies), which provides that, upon the terms and subject to the conditions and limitations set forth in the Sale Agreement, we may elect to issue and sell, from time to time, shares of our common shares having an aggregate offering price of up to USD 80.0 (CHF 72.7) million through Jefferies acting as our sales agent. We first replaced this Sale Agreement in Q2 2021 to continue the ATM program and have subsequently replaced this Sale Agreement on August 6, 2024 to continue the ATM program under a new Registration Statement on Form F-3. Under each new Sale Agreement, Jefferies may sell the shares of common shares by any method permitted by law deemed to be an “at the market offering” as defined under the Securities Act of 1933, as amended, in privately negotiated transactions with our consent or in block transactions. Jefferies will use commercially reasonable efforts to sell the shares of common shares subject to the new Sales Agreement from time to time, consistent with its normal sales and trading practices, on mutually agreed terms. We will pay Jefferies a commission of up to 3.0% of the gross sales proceeds of any common shares sold through Jefferies under the new Sales Agreement. We are not obligated to make any sales of common shares under the new Sales Agreement.
We may also consider entering into additional LCAs and selectively partnering for clinical development and commercialization.
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Cash Flows
The following table summarizes AC Immune’s cash flows for the periods indicated:
|
| For the Six Months |
|
| ||
| | Ended June 30, | | | ||
In CHF thousands, unaudited | | 2024 | | 2023 | | Change |
Net cash provided by/(used in): |
|
|
|
|
|
|
Operating activities |
| 74,051 |
| (30,917) |
| 104,968 |
Investing activities |
| (99,377) |
| 37,645 |
| (137,022) |
Financing activities |
| (750) |
| 1,774 |
| (2,524) |
Net increase/(decrease) in cash and cash equivalents |
| (26,076) |
| 8,502 |
| (34,578) |
Operating activities
Net cash provided by operating activities was CHF 74.1 million for the six months ended June 30, 2024, compared with net cash used in operating activities of CHF 30.9 million for the six months ended June 30, 2023. The change in cash provided by operating activities for the six months ended June 30, 2024 was due to (i) the Company’s reporting a net loss of CHF 40.6 million for the period, compared with a net loss of CHF 34.3 million for the same period in 2023, (ii) an increase of CHF 91.6 million in deferred contract revenue, resulting from the receipt of the upfront payment from our agreement with Takeda and (iii) the receipt of the CHF 14.8 million milestone payment from Janssen for the commencement of first Phase 2b clinical study.
Investing activities
Net cash used in investing activities was CHF 99.4 million for the six months ended June 30, 2024, compared with net cash provided by investing activities of CHF 37.6 million for the six months ended June 30, 2023. A net amount of CHF 99.0 million in short-term financial assets was invested in the current period compared to a net maturation of CHF 38.0 million in the comparable prior period.
Financing activities
Net cash used in financing activities was CHF 0.8 million for the six months ended June 30, 2024, compared with net cash provided by financing activities of CHF 1.8 million for the six months ended June 30, 2023. The change of CHF 2.6 million is primarily related to CHF 2.1 million received from proceeds from the sale of treasury shares in public offerings, net of underwriting fees and transaction costs in the prior period compared to CHF 0.1 million in the current period. Additionally, in 2024, the Company paid CHF 0.5 million in transaction costs and stamp duty associated with the public offerings of common shares that had been previously accrued.
Operating Capital Requirements and Plan of Operations
We do not expect to generate revenues from royalties based on product sales unless and until our partners or we obtain regulatory approval of, and successfully commercialize, our current or any future product candidates. As of June 30, 2024, we had cash and cash equivalents of CHF 51.6 million and short-term financial assets of CHF 123.6 million, resulting in CHF 175.2 million of liquidity. The increase of CHF 72.1 million relative to December 31, 2023 was predominantly related to the receipt of the upfront payment of USD 100.0 (CHF 92.3) million from Takeda as part of the option and license agreement for ACI-24.060 and the CHF 14.8 million milestone payment from Janssen for the commencement of first Phase 2b clinical study of ACI-35.030.This was partially offset by 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, along with the assumed potential milestone payment of CHF 24.6 million related to achieving a non-disclosed enrollment target for our ACI-35.030, and no other milestones, will be sufficient to meet our projected operating requirements for three years. There can be no certainty as to the exact timing of future milestone payments (including option exercise fees), or in fact, whether any of these will ever be made, given that they are contingent on clear milestones being reached or the option being exercised.
We expect to generate losses for the foreseeable future, and these losses could increase as we continue product development until we successfully achieve regulatory approvals for our product candidates and begin to commercialize
11
any approved products. We are subject to all the risks pertinent to the development of new products, and we may encounter unforeseen expenses, difficulties, complications, delays and other unknown factors that may harm our business. We anticipate that we will need substantial additional funding in connection with our continuing operations. If we need to raise additional capital to fund our operations and complete our ongoing and planned clinical studies, funding may not be available to us on acceptable terms, or at all.
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. |
Quantitative and Qualitative Disclosures about Market Risk
During the three and six months ended June 30, 2024, there were no significant changes to our quantitative and qualitative disclosures about market risk described under the heading “Management’s Discussion and Analysis of Financial Condition and Results of Operations – Quantitative and Qualitative Disclosures About Market Risk” in the Annual Report on Form 20-F.
Critical Judgments and Accounting Estimates
There have been no material changes to the significant accounting policies and estimates described under the heading “Management’s Discussion and Analysis of Financial Condition and Results of Operations – Critical Judgments and Accounting Estimates” in the Annual Report on Form 20-F.
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Cautionary Statement Regarding Forward Looking Statements
This discussion and analysis contains statements that constitute forward-looking statements. All statements other than statements of historical facts contained in this discussion and analysis, including statements regarding our future results of operations and financial position, business strategy, product candidates, product pipeline, ongoing and planned clinical studies, including those of our collaboration partners, regulatory approvals, R&D costs, timing and likelihood of success, as well as plans and objectives of management for future operations are forward-looking statements. Many of the forward-looking statements contained in this prospectus can be identified by the use of forward-looking words such as “anticipate,” “believe,” “could,” “expect,” “should,” “plan,” “intend,” “estimate,” “will” and “potential,” among others. Forward-looking statements appear in a number of places in this discussion and analysis and include, but are not limited to, statements regarding our intent, belief or current expectations. Forward-looking statements are based on our management’s beliefs and assumptions and on information currently available to our management. Such statements are subject to risks and uncertainties, and actual results may differ materially from those expressed or implied in the forward-looking statements due to various factors, including, but not limited to, those identified under the section entitled “Risk Factors” in our Annual Report on Form 20-F. These forward-looking statements speak only as of the date of this discussion and analysis, and are subject to a number of risks, uncertainties and assumptions as described under the sections in our Annual Report on Form 20-F entitled “Risk Factors” and in this discussion and analysis. Because forward-looking statements are inherently subject to risks and uncertainties, some of which cannot be predicted or quantified and some of which are beyond our control, you should not rely on these forward-looking statements as predictions of future events. The events and circumstances reflected in our forward-looking statements may not be achieved or occur, and actual results could differ materially from those projected in the forward-looking statements. Moreover, we operate in an evolving environment. New risk factors and uncertainties may emerge from time to time and it is not possible for management to predict all risk factors and uncertainties. Except as required by applicable law, we do not plan to publicly update or revise any forward-looking statements contained herein, whether as a result of any new information, future events, changed circumstances or otherwise.
13
Exhibit 99.3
| | PRESS RELEASE |
AC Immune Reports Second Quarter 2024 Financial Results and
Provides a Corporate Update
| ● | Announced exclusive option and license agreement with Takeda for ACI-24.060 on May 13 for $100 million upfront and total potential milestones of up to approximately $2.1 billion |
| ● | ACI-24.060 ABATE Phase 2 trial in Alzheimer’s disease (AD) on track with enrolment expectations |
| ● | ACI-7104.056 VacSYn Phase 2 trial of anti-a-syn active immunotherapy in Parkinson’s disease (PD) on track for safety and immunogenicity interim data in H2 2024 |
| ● | Potent inhibitor of the inflammatory NLRP3 pathway, ACI-19764, demonstrates promising preclinical results and may be broadly applicable to treat CNS and non-CNS diseases |
| ● | Cash balance of CHF 175.2 million at quarter end, including CHF 92.3 million from Takeda, provides sufficient runway for three years |
Lausanne, Switzerland, August 6, 2024 – AC Immune SA (NASDAQ: ACIU), a clinical-stage biopharmaceutical company pioneering precision therapeutics for neurodegenerative diseases, today reported results for the quarter ended June 30, 2024, and provided a corporate update.
Dr. Andrea Pfeifer, CEO of AC Immune SA, commented, “AC Immune is entering the second half of 2024 with tremendous momentum. We are excited about the recently announced partnership with Takeda for ACI-24.060 as a potential best-in-class Abeta-targeted active immunotherapy. Enrollment in the ABATE Phase 2 trial of ACI-24.060 in AD continues to progress as planned.”
“We are also excited to be advancing our preclinical programs, some of which were recently featured in multiple presentations at the AAIC 2024 conference. Our novel morADC platform, a synergistic combination of our SupraAntigen® and Morphomer® platforms, has significant potential for enhanced targeted interventions for a variety of neurodegenerative diseases and also offers opportunities for simultaneous combination approaches. These morADCs are already showing promise in multiple preclinical models, and we look forward to sharing more details on this and on other preclinical development programs in an upcoming R&D day. Our solid financial position, enhanced by the Takeda partnership, enables us to drive clinical and preclinical development, leveraging the core competency of AC Immune that is anchored by our foundational expertise in neurodegenerative disease drug discovery.”
Q2 2024 and Subsequent Highlights
| ◾ | AC Immune and Takeda signed an exclusive option and license agreement for AC Immune’s active immunotherapies targeting Abeta, including ACI-24.060 for AD. Under the terms of the agreement, AC Immune received an upfront payment of $100 million from Takeda and, if all related milestones are achieved over the course of the agreement, is eligible to receive payments of up to approximately $2.1 billion including an option exercise fee and additional potential development, commercial and sales-based milestones. Upon commercialization, AC Immune will be entitled to receive tiered double-digit royalties on worldwide net sales. |
| ◾ | Enrolment in the ACI-24.060 ABATE Phase 2 AD trial continues. |
| ◾ | We also completed the regulatory toxicology studies for the anti-TDP-43 monoclonal antibody candidate in Q2 which will enable us to proceed with IND filing. |
| ◾ | Our targeted NLRP3 inhibitor candidates continue to show excellent promise in preclinical results featured at the AD/PD™ 2024 conference: |
| o | ACI-19764 is a brain penetrant small molecule in preclinical development that directly binds and inhibits NLRP3. Its activity in vitro and in vivo was demonstrated in two models of neuroinflammation. In addition, ACI-19764 demonstrated an excellent safety profile and optimal exposure for sustained NLRP3 inhibition in the brain. |
| o | AC Immune intends to file an IND from the NLRP3 program in the near future. |
| ◾ | AC Immune’s preclinical programs were featured in multiple presentations at the Alzheimer’s Association International Conference (AAIC) 2024: |
| o | A new class of neurodegenerative disease-fighting drugs: morADC (Morphomer®- antibody drug conjugates), presented by Madiha Derouazi (Chief Scientific Officer, AC Immune), featured data from AC Immune’s proprietary morADC platform. Results demonstrated the ability of morADCs to penetrate the blood brain barrier in vivo and produce potent catalytic activity in vitro compared to the parental monoclonal antibody or small molecule alone. |
| o | Active immunotherapy, ACI-24.060, induces anti-Abeta antibodies with binding profiles mirroring clinically validated monoclonal antibodies, presented by Emma Fiorini (AC Immune), featured results from non-human primates demonstrating that ACI-24.060 induced antibody responses in a similar range of levels of donanemab and lecanemab and with preferential oligomeric Abeta binding as compared to monomeric Abeta. |
| o | Discovery and preclinical development of [18F]ACI-19626, a first-in-class TDP-43 PET tracer, presented by Tamara Seredenina (AC Immune), described the selection of [18F]ACI-19626 for evaluation as a potential PET tracer for detection and monitoring progression of TDP-43 aggregates based on its favorable affinity, selectivity and pharmacokinetic properties. |
| ◾ | Board and Management Share Purchases: Members of the Board of Directors and certain members of executive management purchased shares in AC Immune SA during Q2 2024, following the announcement of the exclusive option and license agreement with Takeda for ACI-24.060. As a foreign private issuer (FPI), individual shareholdings will be disclosed in the Annual Report on Form 20-F. |
Anticipated 2024 Milestones
ACI-24.060 | ● ABATE Phase 2 trial in AD on track with enrolment expectations |
ACI-7104.056 anti-a-syn active immunotherapy | ● Interim safety and immunogenicity update from the Phase 2 VacSYn study in Parkinson’s disease expected in H2 2024 |
ACI-35.030 anti-pTau active immunotherapy | ● First patient treated in ReTain Phase 2b clinical trial expected in the coming months |
TDP-43-PET tracer | ● Phase 1 initiation expected in H2 2024 |
ACI-15916 a-syn-PET tracer | ● IND-enabling studies in PD expected to be completed in H2 2024 |
Analysis of Financial Statements for the Quarter Ended June 30, 2024
| ◾ | Cash Position: The Company had a total cash balance of CHF 175.2 million (CHF 103.1 million as of December 31, 2023), composed of CHF 51.6 million in cash and cash equivalents and CHF 123.6 million in short-term financial assets. The Company’s cash balance provides sufficient capital resources for three years, assuming the potential milestone payment of CHF 24.6 million related to achieving an undisclosed enrolment target for our ACI-35.030, and no other milestones. |
| ◾ | Contract Revenues: The Company recorded CHF 0.7 million in contract revenues for the three months ended June 30, 2024, compared to nil in the comparable prior period. For the three months ended June 30, 2024, our contract revenues of CHF 0.7 million were related to the efforts made under the agreement with Takeda. |
| ◾ | R&D Expenditures: R&D expenses for the three months ended June 30, 2024, were CHF 17.1 million compared to CHF 13.7 million in the comparable period in 2023. The increase was due mainly to higher clinical expenses, driven by the ramp-up activities for our Phase 2 VacSYn study evaluating ACI-7104.056 in early PD and for the expansion of the ABATE study in our ACI-24.060 active immunotherapy. |
| ◾ | G&A Expenditures: G&A increased by CHF 0.9 million to CHF 4.6 million, mostly due to an increase in legal fees related to business development and licensing activities, as well as salaries and related costs, largely attributable to the higher expenses from equity awards granted in 2024, which have a higher fair value based on our share price development. |
| ◾ | Other Operating Income: The Company recognized less than CHF 0.1 million in grant income from Target ALS grants. |
| ◾ | IFRS Loss for the Period: The Company reported a net loss after taxes of CHF 22.8 million for the three months ended June 30, 2024, compared with a net loss of CHF 16.8 million for the comparable period in 2023. |
About AC Immune SA
AC Immune SA is a clinical-stage biopharmaceutical company and a global leader in precision prevention for neurodegenerative diseases, including Alzheimer’s disease, Parkinson’s disease, and NeuroOrphan indications driven by misfolded proteins. The Company’s two clinically validated technology platforms, SupraAntigen® and Morphomer®, fuel its broad and diversified pipeline of first- and best-in-class assets, which currently features sixteen therapeutic and diagnostic programs, including five in Phase 2 development and one in Phase 3. AC Immune has a strong track record of securing strategic partnerships with leading global pharmaceutical companies, resulting in substantial non-dilutive funding to advance its proprietary programs and >$4.5 billion in potential milestone payments plus royalties.
SupraAntigen® is a registered trademark of AC Immune SA in the following territories: AU, EU, CH, GB, JP, RU, SG and USA. Morphomer® is a registered trademark of AC Immune SA in CN, CH, GB, JP, KR, NO and RU.
The information on our website and any other websites referenced herein is expressly not incorporated by reference into, and does not constitute a part of, this press release.
For further information, please contact:
SVP, Investor Relations & Corporate Communications Gary Waanders, Ph.D., MBA AC Immune Phone: +41 21 345 91 91 Email: gary.waanders@acimmune.com | U.S. Investors Corey Davis, Ph.D. LifeSci Advisors Phone: +1 212 915 2577 Email: cdavis@lifesciadvisors.com
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International Media Chris Maggos Cohesion Bureau Phone: +41 79 367 6254 Email: chris.maggos@cohesionbureau.com |
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Forward looking statements
This press release contains statements that constitute “forward-looking statements” within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. Forward-looking statements are statements other than historical fact and may include statements that address future operating, financial or business performance or AC Immune’s strategies or expectations. In some cases, you can identify these statements by forward-looking words such as “may,” “might,” “will,” “should,” “expects,” “plans,” “anticipates,” “believes,” “estimates,” “predicts,” “projects,” “potential,” “outlook” or “continue,” and other comparable terminology. Forward-looking statements are based on management’s current expectations and beliefs and involve significant risks and uncertainties that could cause actual results, developments and business decisions to differ materially from those contemplated by these statements. These risks and uncertainties include those described under the captions “Item 3. Key Information – Risk Factors” and “Item 5. Operating and Financial Review and Prospects” in AC Immune’s Annual Report on Form 20-F and other filings with the Securities and Exchange Commission. Forward-looking statements speak only as of the date they are made, and AC Immune does not undertake any obligation to update them in light of new information, future developments or otherwise, except as may be required under applicable law. All forward-looking statements are qualified in their entirety by this cautionary statement.
Condensed Consolidated Balance Sheets (Unaudited)
(In CHF thousands)
|
| As of | ||
| | June 30, | | December 31, |
| | 2024 | | 2023 |
Assets |
|
|
|
|
Non-current assets |
|
|
|
|
Property, plant and equipment |
| 2,926 |
| 3,376 |
Right-of-use assets |
| 3,235 |
| 3,508 |
Intangible asset |
| 50,416 |
| 50,416 |
Long-term financial assets |
| 415 |
| 361 |
Total non-current assets |
| 56,992 |
| 57,661 |
Current assets |
| |
| |
Prepaid expenses |
| 3,864 |
| 6,437 |
Accrued income |
| 402 |
| 246 |
Other current receivables |
| 1,153 |
| 622 |
Accounts receivable | | — | | 14,800 |
Short-term financial assets |
| 123,560 |
| 24,554 |
Cash and cash equivalents |
| 51,564 |
| 78,494 |
Total current assets |
| 180,543 |
| 125,153 |
Total assets |
| 237,535 |
| 182,814 |
| | | | |
Shareholders' equity and liabilities |
| |
| |
Shareholders’ equity |
| |
| |
Share capital |
| 2,212 |
| 2,089 |
Share premium |
| 476,074 |
| 474,907 |
Treasury shares |
| (218) |
| (105) |
Currency translation differences |
| (35) |
| (51) |
Accumulated losses |
| (354,608) |
| (316,197) |
Total shareholders’ equity |
| 123,425 |
| 160,643 |
| | | | |
Non-current liabilities |
| |
| |
Long-term deferred contract revenue | | 5,170 | | — |
Long-term lease liabilities |
| 2,542 |
| 2,825 |
Net employee defined benefit liabilities |
| 5,868 |
| 5,770 |
Total non-current liabilities |
| 13,580 |
| 8,595 |
| | | | |
Current liabilities |
| |
| |
Trade and other payables |
| 1,435 |
| 1,679 |
Accrued expenses |
| 11,895 |
| 11,087 |
Short-term deferred income | | 45 | | 138 |
Short-term deferred contract revenue |
| 86,468 |
| — |
Short-term lease liabilities |
| 687 |
| 672 |
Total current liabilities |
| 100,530 |
| 13,576 |
Total liabilities |
| 114,110 |
| 22,171 |
Total shareholders’ equity and liabilities |
| 237,535 |
| 182,814 |
Condensed Consolidated Statements of Income/(Loss) (Unaudited)
(In CHF thousands, except for per-share data)
| | For the Three Months | | For the Six Months | ||||
| | Ended June 30, | | Ended June 30, | ||||
|
| 2024 |
| 2023 |
| 2024 |
| 2023 |
Revenue |
|
|
|
|
|
|
|
|
Contract revenue |
| 687 |
| — |
| 687 |
| — |
Total revenue |
| 687 |
| — |
| 687 |
| — |
|
| |
| |
| |
| |
Operating expenses |
| |
| |
| |
| |
Research & development expenses |
| (17,138) |
| (13,682) |
| (32,303) |
| (27,555) |
General & administrative expenses |
| (4,551) |
| (3,681) |
| (9,522) |
| (7,787) |
Other operating income/(expense), net |
| 41 |
| 317 |
| 109 |
| 725 |
Total operating expenses |
| (21,648) |
| (17,046) |
| (41,716) |
| (34,617) |
Operating loss |
| (20,961) |
| (17,046) |
| (41,029) |
| (34,617) |
| | | | | | | | |
Financial income |
| 739 |
| 259 |
| 1,368 |
| 468 |
Financial expense |
| (34) |
| (27) |
| (70) |
| (124) |
Exchange differences |
| (2,504) |
| (16) |
| (891) |
| (67) |
Finance result, net |
| (1,799) |
| 216 |
| 407 |
| 277 |
| | | | | | | | |
Loss before tax |
| (22,760) |
| (16,830) |
| (40,622) |
| (34,340) |
Income tax expense |
| — |
| (3) |
| — |
| (6) |
Loss for the period |
| (22,760) |
| (16,833) |
| (40,622) |
| (34,346) |
Loss per share: |
| (0.23) |
| (0.20) |
| (0.41) |
| (0.41) |
Condensed Consolidated Statements of Comprehensive Income/(Loss) (Unaudited)
(In CHF thousands)
| | For the Three Months | | For the Six Months | ||||
| | Ended June 30, | | Ended June 30, | ||||
|
| 2024 |
| 2023 |
| 2024 |
| 2023 |
Loss for the period |
| (22,760) |
| (16,833) |
| (40,622) |
| (34,346) |
Items that will be reclassified to income or loss in subsequent periods (net of tax): |
| |
| |
| |
|
|
Currency translation differences |
| — |
| (8) |
| 16 |
| (16) |
Items that will not to be reclassified to income or loss in subsequent periods (net of tax): |
| |
| |
| |
|
|
Remeasurement gains on defined-benefit plans |
| — |
| — |
| — |
| — |
Total comprehensive loss (net of tax) |
| (22,760) |
| (16,841) |
| (40,606) |
| (34,362) |