Altamira Therapeutics .(CYTO) - 2024 Q4 - Annual Report

FORM 20-F Filing Information Details Altamira Therapeutics Ltd.'s Form 20-F filing for FY2024, including registrant and securities information Registrant Information Identifies Altamira Therapeutics Ltd. as a Bermuda-incorporated company filing an Annual Report on Form 20-F for FY2024 - Altamira Therapeutics Ltd. is filing an Annual Report on Form 20-F for the fiscal year ended December 31, 2024[1] - The company is incorporated in Bermuda with principal executive offices at Clarendon House, 2 Church Street, Hamilton HM11, Bermuda[2] Securities Information Details the company's Common Shares trading on OTCQB under CYTOF, outstanding shares, and IFRS financial statements Title of each class | Title of each class | Trading Symbol(s) | Name of each exchange on which registered | | :------------------ | :---------------- | :---------------------------------------- | | Common Shares, par value $0.002 per share | CYTOF | OTCQB | - 4,662,080 common shares were outstanding as of the close of the reporting period[7] - The registrant is not a well-known seasoned issuer, a large accelerated filer, or an emerging growth company[8][11][12] - Financial statements are prepared in accordance with International Financial Reporting Standards as issued by the International Accounting Standards Board (IFRS)[12] Forward-Looking Statements Cautions that the Annual Report contains forward-looking statements subject to risks and uncertainties, with no obligation to update - The Annual Report contains forward-looking statements identifiable by words such as 'anticipate,' 'believe,' 'expect,' 'plan,' 'intend,' 'will,' 'estimate,' and 'potential'[23] - Forward-looking statements are subject to risks and uncertainties, and actual results may differ materially due to factors including product development, clinical utility, regulatory approvals, intellectual property, key personnel dependence, and financing needs[24] - The company does not assume any obligation to update forward-looking statements as circumstances change[24] PART I Covers company identity, offer statistics, key information including risk factors, and business overview ITEM 1. Identity of Directors, Senior Management and Advisers This item is marked as 'Not applicable', indicating no specific disclosures regarding directors, senior management, and advisers - This item is marked as 'Not applicable' for Directors and senior management, Advisers, and Auditors[27][28][29] ITEM 2. Offer Statistics and Expected Timetable This item is marked as 'Not applicable', indicating no specific disclosures regarding offer statistics and expected timetable - This item is marked as 'Not applicable' for Offer statistics and Method and expected timetable[30][31] ITEM 3. Key Information Outlines critical information, including risk factors, development-stage status, operating losses, and substantial funding needs - The company is a biopharmaceutical company with product candidates still in the development stage and a limited operating history, incurring significant operating losses since inception[35] - Substantial additional funding is required for research and development, and there is substantial doubt about the company's ability to continue as a going concern if capital cannot be raised[39][40] - Raising additional capital may cause dilution to shareholders, restrict operations, or require relinquishing intellectual property rights or future revenue streams[42][43] - The company is working to divest or partner its legacy assets (Bentrio, AM-125) but cannot assure success or favorable terms, which could impact business and results of operations[44][46] - Cyber-attacks or failures in IT systems could lead to information theft, data corruption, and significant disruption of business operations[48] A. [Reserved] This sub-item is marked as 'Not applicable' - This sub-item is marked as 'Not applicable'[32] B. Capitalization and Indebtedness This sub-item is marked as 'Not applicable' - This sub-item is marked as 'Not applicable'[37] C. Reasons for the Offer and Use of Proceeds This sub-item is marked as 'Not applicable' - This sub-item is marked as 'Not applicable'[33] D. Risk Factors The company faces significant risks from development-stage products, limited operating history, future losses, and funding needs Risks Related to the Development and Clinical Testing of Our Product Candidates Success of xPhore platform and programs depends on successful development, regulatory approval, and out-licensing, facing lengthy, expensive, and uncertain outcomes - The xPhore platform and AM-401/AM-411 programs are in preclinical development; their success depends on successful development, regulatory approval, and out-licensing[49][50] - Drug development is a lengthy, expensive, and speculative process, with preclinical results not always predictive of human clinical trial outcomes[51] - Serious adverse side effects during development or after approval could lead to abandonment, limited commercialization, or other negative consequences[55][56] - Limited resources require prioritizing certain product candidates, and incorrect decisions could adversely affect revenues[57] Risks Related to Commercialization of Our Products and Product Candidates The highly competitive biopharmaceutical industry poses a risk that competitors may develop or commercialize products more successfully or earlier - The biopharmaceutical industry is highly competitive and subject to rapid technological change, with success dependent on the ability to discover, develop, and out-license product candidates successfully[58] - The company faces intense competition from large pharmaceutical companies, specialty biopharmaceutical companies, academic institutions, and government agencies with potentially greater resources[58] Risks Related to Our Reliance on Third Parties Business heavily relies on Washington University license, third-party CROs, and single-source suppliers, risking relationship deterioration, funding delays, and supply chain disruptions - Maintaining the strategic relationship and exclusive license agreement with Washington University is critical for AM-401 and AM-411 development, as challenges to intellectual property or payment calculations could adversely affect the business[59][61][62] - Future strategic alliances are necessary for funding and expertise, but competition for collaborators is significant, and failure to secure them on acceptable terms could delay or terminate product development[63][64] - Reliance on third-party CROs for nonclinical and clinical trials poses risks if they fail to meet contractual duties, deadlines, or regulatory requirements, potentially delaying regulatory approval[65][66] - Dependence on single-source third-party suppliers for ingredients and manufacturing of RNA delivery platforms and product candidates could impair research and development if alternative sources are not timely or commercially reasonable[67][68] Risks Related to Intellectual Property Success hinges on obtaining and maintaining effective patent rights, which is expensive and uncertain, with risks of limited lifespans, trade secret misappropriation, and infringement claims - Obtaining and maintaining effective patent rights for RNA delivery platforms and product candidates is crucial but expensive, time-consuming, and uncertain, with no assurance of broad enough scope or protection against competitors[69][70][71] - Patents have limited lifespans, and there is no assurance of obtaining sufficient patent term extensions or market protection (e.g., data exclusivity) for product candidates, potentially leading to generic competition[74][75][76] - Reliance on trade secret protection and confidentiality agreements is vulnerable to breaches, independent discovery, or inadequate legal recourse, which could impair competitive position[77][78][79] - Third-party claims of intellectual property infringement could lead to substantial liability, injunctions, or significant litigation expenses, delaying or preventing development and commercialization[80][81][82] - Failure to comply with obligations under the Exclusive License Agreement with Washington University could result in the loss of intellectual property rights vital for AM-401 and AM-411[83][84] Risks Related to Employee Matters and Managing Growth Future growth depends on retaining key personnel and recruiting qualified individuals in a highly competitive biopharmaceutical field - Success depends on retaining key management (Thomas Meyer, Covadonga Pañeda, Marcel Gremaud) and scientific personnel (Samuel Wickline) and recruiting additional qualified personnel[94] - Loss of key managers or senior scientists could delay R&D activities, and intense competition for qualified personnel in the biopharmaceutical field poses a risk to implementing business strategy[95] Risks Related to Our Common Shares Common share price is highly volatile, subject to dilution, no expected dividends, potential PFIC classification, and challenges in enforcing judgments due to Bermuda law - The price of common shares is highly volatile due to factors like technological innovations, government regulations, supplier issues, and general market conditions[96][97][98][103] - Future sales of a substantial number of common shares could adversely affect the stock price[99] - The company does not expect to pay dividends in the foreseeable future, with any returns dependent on share price appreciation[100] - Classification as a Passive Foreign Investment Company (PFIC) could result in adverse U.S. federal income tax consequences for U.S. shareholders[101][102][105] - As a foreign private issuer, the company is exempt from certain U.S. proxy rules and reporting obligations, potentially offering less protection to shareholders[105] - Failure to maintain effective internal control over financial reporting could lead to inaccurate financial results or fraud, harming business and stock price, despite remediation efforts in 2024[106][107][108][109] - Enforcing judgments against the company or its non-U.S. directors/executive officers may be difficult due to Bermuda's legal framework, which differs from U.S. laws and may offer less shareholder protection[110][111][112][113][114] - Anti-takeover provisions in the Bye-laws, such as director removal for cause and supermajority voting for certain transactions, may discourage changes of control[115][117] - Compliance with Bermuda's Economic Substance Act 2018 may affect operations or result in additional costs[116][118] ITEM 4. Information on the Company Overview of Altamira Therapeutics Ltd.'s history, strategic repositioning towards RNA delivery, xPhore platform, product candidates, and competitive landscape A. History and Development of the Company Altamira Therapeutics Ltd., incorporated in Bermuda in 2019, is a preclinical-stage biopharmaceutical firm focused on peptide-based nanoparticle technologies for RNA delivery, strategically repositioning by divesting legacy assets - Altamira Therapeutics Ltd. was originally Auris Medical AG, redomesticated to Bermuda in 2019, and adopted its current name in 2021[119] - The company is a preclinical-stage biopharmaceutical company developing peptide-based nanoparticle technologies for efficient RNA delivery to extrahepatic tissues (xPhore platform)[121] - Key platforms include OligoPhore (siRNA), SemaPhore (linear mRNA), and CycloPhore (circular mRNA), offered for out-licensing[121] - The company is repositioning by spinning off a 51% stake in Altamira Medica AG (Bentrio business) and intends to divest other legacy assets like AM-125[122] Capital Expenditures (2022-2024) | Year | Capital Expenditures (in $ million) | | :--- | :-------------------------------- | | 2024 | 0.1 | | 2023 | 0 | | 2022 | 2.1 | B. Business Overview Altamira's strategy is to become a leading RNA delivery technology company, focusing on its xPhore platform, advancing flagship siRNA programs, and divesting non-RNA businesses - Strategy: Become a leading biomedical company focused on developing and commercializing RNA delivery technology, leveraging the xPhore platform through partnering, demonstrating proof of concept with flagship programs (AM-401, AM-411), and divesting non-RNA businesses[124][125][130] - xPhore platform: A versatile peptide polyplex for systemic or local delivery of siRNA, mRNA, or circRNA to extrahepatic tissues, designed for stability, efficient cellular uptake, and endosomal escape, with demonstrated efficacy in over 15 murine disease models[125][126][127][128][135][136] Global RNA Therapeutics Market Growth Projections | Market Segment | 2021 (USD Billion) | 2026/2030 (USD Billion) | | :--------------- | :----------------- | :---------------------- | | RNAi and ASOs | 4.9 | 25.1 (by 2030) | | mRNA Therapeutics | 46.7 | 101.3 (by 2026) | - AM-401 targets KRAS-driven cancers (e.g., colorectal, pancreatic, NSCLC) using polyKRAS siRNA, aiming to knock down a broad range of KRAS mutations, unlike current small molecule inhibitors that target only G12C[137][138][139][140][141][142] - AM-411 targets the NF-κB signaling pathway in rheumatoid arthritis (RA) using p65 siRNA, demonstrating potential to reduce local inflammation and protect against bone erosion in murine models without systemic side effects[143][144][145][146] - Legacy assets include AM-125 (nasal spray for vertigo, post Phase 2, IND cleared in US, intended for out-licensing/sale) and Bentrio (OTC nasal spray for allergic rhinitis, partially spun off in 2023, 49% stake retained, FDA cleared as Class II device)[147][148][149] - Competition exists from numerous biopharmaceutical companies in RNA delivery technologies, KRAS-driven cancer treatments (small molecules, other RNA therapies), and rheumatoid arthritis therapeutics (biologics, JAK inhibitors, DMARDs)[150][151][152][153][154][155] - Intellectual property strategy involves patents (exclusive license with Washington University for RNA delivery, patents for AM-401/AM-411 expiring 2034-2044, AM-125 patents expiring 2038) and proprietary rights like marketing exclusivity and trade secrets[156][159][160][161][162][163][164] - The company relies on third parties for raw materials and manufacturing of RNA delivery platforms and product candidates, while intending to retain control of critical manufacturing processes for strategic purposes[168] - Commercialization strategy for RNA activities is focused on out-licensing technology to partners in the biopharmaceutical industry rather than direct commercialization[169] - Regulatory agencies classify xPhore as a nanomaterial carrier and AM-401/AM-411 as drug products, requiring extensive preclinical and clinical testing and regulatory approval, which is a substantial, time-consuming, and uncertain process[170][171][172][173] - Sales of approved drug products depend on coverage and adequate reimbursement from third-party payors (government, managed care, private insurers)[174] C. Organizational Structure As of December 31, 2024, Altamira Therapeutics Ltd. had three wholly-owned subsidiaries and one associated company, Altamira Medica AG, with its primary operating subsidiary in Basel, Switzerland - As of December 31, 2024, the registrant had three wholly-owned subsidiaries and one associated company, Altamira Medica AG[175] - The principal operating subsidiary is Altamira Therapeutics AG, operating out of Basel, Switzerland[175] D. Property, Plants and Equipment The company's registered office is in Bermuda, and it leases approximately 4,700 square feet of office space in Basel, Switzerland, with about 40% sublet - The registered office is in Hamilton, Bermuda[176] - The company leases approximately 4,700 square feet of office space in Basel, Switzerland, for its principal operating subsidiary, with about 40% sublet to a third party[176] ITEM 4A. Unresolved Staff Comments This item is marked as 'Not applicable', indicating no unresolved staff comments - This item is marked as 'Not applicable'[177] ITEM 5. Operating and Financial Review and Prospects Detailed discussion of Altamira Therapeutics Ltd.'s financial condition and results, covering strategic repositioning, operating results, liquidity, capital resources, and going concern A. Operating Results Altamira is a preclinical-stage biopharmaceutical company focused on RNA delivery technology; net loss increased in 2024 due to higher R&D spending and non-recurrence of 2023 profit from discontinued operations - Altamira is a preclinical-stage biopharmaceutical company focused on RNA delivery technology (xPhore platform) and proprietary programs AM-401 and AM-411[179] - The company is strategically repositioning by divesting legacy assets, including a 51% stake in Altamira Medica AG (Bentrio business) in 2023, and plans to divest AM-125 and other legacy programs[179][182][183][184] - The company has initiated collaborations for its xPhore platform, including with Heqet Therapeutics (2023), Univercells (2024), and an undisclosed partner (2024)[180] - Management aims to achieve IND clearance for AM-401 or AM-411 by 2026[181] Consolidated Statement of Profit or Loss and Other Comprehensive Income/(Loss) (in thousands of US$) | Item | 2024 | 2023 | 2022 | | :-------------------------------------- | :----- | :----- | :------- | | Other operating income | 75 | 284 | 10 | | Research and development | (3,727) | (3,378) | (15,311) | | General and administrative | (3,199) | (3,491) | (3,562) | | Operating loss | (6,851) | (6,584) | (18,863) | | Finance income | 3 | 394 | 592 | | Finance expense | (837) | (1,857) | (1,268) | | Share of loss of an associate | (773) | (44) | - | | Loss before tax | (8,458) | (8,091) | (19,539) | | Income tax gain/(loss) | - | - | 8 | | Net loss from continuing operations | (8,458) | (8,091) | (19,531) | | Profit/(loss) after tax from discontinued operations | - | 3,785 | (8,248) | | Net loss attributable to owners of the Company | (8,458) | (4,306) | (27,779) | - Net loss for 2024 increased from 2023 primarily due to higher R&D spending and the non-recurrence of a profit from discontinued operations in 2023[190] - Net loss for 2023 decreased substantially from 2022 due to the non-recurrence of a non-cash write-off (impairment) of AM-125 development costs and the deconsolidation of Medica[191] Research and Development Expense (in thousands of US$) | Item | 2024 | 2023 | 2022 | | :-------------------------- | :----- | :----- | :------- | | Pre-clinical projects | (1,831) | (562) | (408) | | Clinical projects | (73) | (143) | (70) | | Product and process development | (20) | (406) | (209) | | Employee benefits and expenses | (1,599) | (1,591) | (1,494) | | Patents and trademarks | (186) | (462) | (163) | | Regulatory projects | (4) | (66) | (36) | | Impairment intangible assets | - | - | (12,920) | | Other research and development expense | (15) | (148) | (11) | | Total research and development expense | (3,727) | (3,378) | (15,311) | - R&D expenses rose in 2024 vs. 2023 due to higher project work related to RNA delivery (pre-clinical testing, product/process development) and patent expenditures, while clinical project spending decreased[192] - R&D expenses decreased substantially in 2023 compared to 2022 primarily due to the absence of the non-cash impairment write-off of AM-125 development costs[193] General and Administrative Expense (in thousands of US$) | Item | 2024 | 2023 | 2022 | | :-------------------------- | :----- | :----- | :----- | | Employee benefits and expenses | (829) | (730) | (676) | | Business development | - | (17) | (17) | | Travel expenses | (38) | (48) | (100) | | Administration expenses | (2,146) | (2,531) | (2,636) | | Lease expenses from short-term lease | (55) | (18) | (6) | | Depreciation of Right-of-use assets | (127) | (133) | (124) | | Capital tax expenses | (4) | (14) | (3) | | Total general and administrative expenses | (3,199) | (3,491) | (3,562) | - General and administrative expenses decreased in 2024 from 2023 mainly due to lower general administrative expenses, partly offset by higher employee benefits from increased headcount[194] B. Liquidity and Capital Resources Altamira has historically financed operations through equity and loans, incurring significant losses, and requires substantial additional funding, raising doubt about its going concern ability - Since inception, the company has incurred significant operating losses and financed operations through public/private equity offerings and loans[196] Consolidated Statement of Cash Flows (in thousands of US$) | Item | 2024 | 2023 | 2022 | | :---------------------------------- | :----- | :----- | :----- | | Net cash used in operating activities | (6,114) | (12,811) | (9,092) | | Net cash from / used in investing activities | (115) | 1,608 | (2,243) | | Net cash from financing activities | 6,505 | 11,821 | 10,295 | | Net effect of currency translation on cash | (11) | 99 | (23) | | Cash and cash equivalents at the beginning of the period | 734 | 17 | 1,080 | | Cash and cash equivalents at the end of the period | 999 | 734 | 17 | - Net cash used in operating activities decreased substantially in 2024, reflecting a lower cash loss and stable net working capital, compared to an increase in 2023[197] - Net cash from financing activities in 2024 resulted from the sale of common shares, lower than 2023 which included proceeds from warrants and convertible loans[199] Sources of Financing (in US$) | Year | Equity Capital and Preference Shares | Loans | Total | | :--- | :----------------------------------- | :---- | :---- | | 2024 | 6,654,620 | - | 6,654,620 | | 2023 | 10,819,067 | 2,782,415 | 13,601,482 | | 2022 | 4,112,169 | 6,323,170 | 10,435,339 | | Total | 21,585,856 | 9,105,585 | 30,691,441 | - All loans were repaid or converted into common shares by 2023, with no loans outstanding in 2024[203] - The company expects to require additional funding for RNA delivery R&D and public company operations, and the inability to raise capital raises substantial doubt about its ability to continue as a going concern[206][207] C. Research and Development, Patents and Licenses, etc. This section refers to information detailed in 'Item 4. Information on the Company—A. History and Development of the Company,' 'Item 4. Information on the Company—B. Business Overview,' and 'Item 5. Operating and Financial Review and Prospects—A. Operating Results – Results of Operations.' - This section refers to information detailed in 'Item 4. Information on the Company—A. History and Development of the Company,' 'Item 4. Information on the Company—B. Business Overview,' and 'Item 5. Operating and Financial Review and Prospects—A. Operating Results – Results of Operations'[213] D. Trend Information This section refers to information detailed in 'Item 5. Operating and Financial Review and Prospects.' - This section refers to information detailed in 'Item 5. Operating and Financial Review and Prospects'[213] E. Critical Accounting Estimates This item is marked as 'Not applicable', indicating no specific critical accounting estimates are discussed - This item is marked as 'Not applicable'[213] F. Safe Harbor This section refers to the 'Forward-Looking Statements' section - This section refers to the 'Forward-Looking Statements' section[214] ITEM 6. Directors, Senior Management and Employees Details executive officers, non-executive directors, compensation, board practices, employee information, and equity incentive plans A. Directors and Senior Management Executive officers include Thomas Meyer (CEO), Covadonga Pañeda (COO), and Marcel Gremaud (CFO), with non-executive directors Mats Blom, Alain Munoz, and Dominik Lysek Executive Officers and Non-Executive Directors | Name | Position | Age | Initial Year of Appointment | | :-------------- | :------------------------------------- | :-- | :------------------------ | | Executive Officers | | | | | Thomas Meyer | Chairman, Director and Chief Executive Officer | 57 | 2003 | | Covadonga Pañeda | Chief Operating Officer | 51 | 2022 | | Marcel Gremaud | Chief Financial Officer | 67 | 2021 | | Non-Executive Directors | | | | | Mats Blom | Director | 60 | 2017 | | Alain Munoz | Director | 76 | 2018 | | Dominik Lysek | Director | 50 | 2024 | - Thomas Meyer founded Auris Medical in 2003 and has served as Chairman and CEO since then[216] - Covadonga Pañeda, with over 15 years of drug development experience, joined as Chief Development Officer in April 2022 and was promoted to Chief Operating Officer in January 2023[217] - Marcel Gremaud has been CFO since November 2021, bringing over 30 years of experience in controlling and accounting in international pharma[218] B. Compensation In 2024, aggregate compensation for directors and executive officers was $1,262,177, with $44,469 for pension benefits, and an Equity Incentive Plan is in place - Aggregate compensation for board members and executive officers in 2024 was $1,262,177 (2023: $1,398,434)[222] - Amount set aside for pension, retirement, or similar benefits for directors and executive officers in 2024 was $44,469 (2023: $49,050)[222] Compensation Awarded to Board of Directors in 2024 (in US$) | In US$ | Cash Compensation | Social Contributions | Stock Options (3) | Total | | :------- | :---------------- | :------------------- | :---------------- | :---- | | Margarit Schwarz (2) | 16,875 | - | - | 16,875 | | Dominik Lysek | 22,500 | - | - | 22,500 | | Mats Blom | 45,000 | - | 18,227 | 63,227 | | Alain Munoz | 45,000 | - | 18,227 | 63,227 | | Total | 129,375 | - | 36,454 | 165,829 | Compensation Awarded to Executive Officers in 2024 (in US$) | in US$ | Fixed Cash Compensation | Variable Compensation | Social contributions and fringe benefits | Stock Options | Total | | :------- | :---------------------- | :-------------------- | :--------------------------------------- | :------------ | :---- | | Thomas Meyer, Chief Executive Officer | 317,000 | 51,334 | 75,660 | 162,175 | 606,168 | | Executive Officers Total | 621,729 | 115,327 | 98,188 | 261,105 | 1,096,348 | - The company has employment and/or consulting agreements with executive officers, including Thomas Meyer, Covadonga Pañeda, and Marcel Gremaud[227] - An incentive compensation recoupment policy (clawback policy) was adopted on November 15, 2023, but revoked following the delisting of common shares from Nasdaq in December 2024[229] - The Equity Incentive Plan (EIP) was established in 2014 to motivate and reward employees and other contributors, with 303,313 common shares available for award as of December 31, 2024[230] - Options under the EIP typically vest after 12 months (directors) or 2-3 years (employees) of service[233] - The company's Bye-laws and Bermuda law provide for indemnification of officers and directors, except in cases of fraud or dishonesty, and the company maintains a directors' and officers' liability policy[236][237] C. Board Practices The board of directors consists of four members, each elected for a one-year term, with an Audit Committee (Mats Blom as financial expert) and a Compensation Committee - The board of directors is currently composed of four members, each elected for a one-year term[239] - As a foreign private issuer, the company's corporate governance requirements may differ from those applicable to U.S. public companies[241] - The Audit Committee consists of Mats Blom (chairman and financial expert), Alain Munoz, and Dominik Lysek, all satisfying independence requirements[242] - The Audit Committee is responsible for overseeing accounting and financial reporting, auditor appointment/oversight, and reviewing internal controls[243][244] - The Compensation Committee, consisting of Alain Munoz and Mats Blom, assists the board in overseeing executive officer compensation and equity award recommendations[245] D. Employees As of December 31, 2024, the company had 13 employees (11.3 FTEs) in Switzerland, primarily in Research & Development, with good employee relations - As of December 31, 2024, the company had 13 employees (11.3 FTEs), all located in Switzerland[246] - Employee breakdown by cost center: 8.4 FTEs in Research & Development and 2.9 FTEs in General & Administration[246] - None of the employees are subject to a collective bargaining agreement or represented by a trade or labor union, and relations are considered good[246] E. Share Ownership This section refers to information detailed in 'Item 7. Major Shareholders and Related Party Transactions—A. Major shareholders.' - This section refers to information detailed in 'Item 7. Major Shareholders and Related Party Transactions—A. Major shareholders'[247] F. Disclosure of a Registrant's Action to Recover Erroneously Awarded Compensation This item is marked as 'Not applicable', indicating no actions to recover erroneously awarded compensation - This item is marked as 'Not applicable'[247] ITEM 7. Major Shareholders and Related Party Transactions Outlines beneficial ownership of common shares by major shareholders, executive officers, and directors, and details various related party transactions A. Major Shareholders As of April 15, 2025, there were 4,662,080 common shares outstanding, with executive officers and directors collectively owning 1.65% - As of April 15, 2025, there were 4,662,080 common shares issued and outstanding[250] Beneficial Ownership of Common Shares (as of April 15, 2025) | Shareholder | Shares Beneficially Owned (Number) | Percent | | :------------------------------------ | :--------------------------------- | :------ | | 5% Shareholders | | | | - | — | — | | Executive Officers and Directors | | | | Thomas Meyer | 26,451 | 0.57% | | Mats Blom | 23,273 | * | | Dominik Lysek | 738 | * | | Alain Munoz | 23,263 | * | | Covadonga Pañeda | 2,865 | * | | Marcel Gremaud | 147 | * | | All current directors and executive officers as a group (6 persons) | 76,737 | 1.65% | - As of April 15, 2025, the company had four shareholders of record[253] B. Related Party Transactions The company has a related person transaction policy, indemnification agreements, employment agreements, and engaged Gremaud GmbH for CFO services, with past loans from CEO Thomas Meyer - A related person transaction policy requires approval or ratification by the audit committee or board of directors[254] - Indemnification agreements are in place for directors and executive officers[255] - Gremaud GmbH, owned by CFO Marcel Gremaud, provided CFO services for $213,714 in 2024 (2023: $276,313)[256] - CEO Thomas Meyer contributed to a loan to the company from September 2022 to July 2023, and his spouse provided a short-term loan to a subsidiary from December 2022 to March 2023[257] C. Interests of Experts and Counsel This item is marked as 'Not applicable', indicating no specific disclosures regarding interests of experts and counsel - This item is marked as 'Not applicable'[260] ITEM 8. Financial Information Refers to consolidated financial statements prepared under IFRS, discusses legal proceedings, and reiterates the company's dividend policy A. Consolidated Statements and Other Financial Information This section directs to 'Item 18. Financial Statements' for IFRS-prepared consolidated financial statements, noting no material legal proceedings and no anticipated cash dividends - Consolidated financial statements are filed as part of this Annual Report under 'Item 18. Financial Statements' and are prepared in accordance with IFRS Accounting Standards[261] - The company has not been a party to or paid damages in connection with litigation that has had a material adverse effect on its financial position[262] - The company has never paid or declared cash dividends and does not anticipate doing so in the foreseeable future, with any future dividend policy at the discretion of the board and subject to legal restrictions[263] B. Significant Changes This section refers to discussions of significant business changes found under 'Item 4. Information on the Company—A. History and development of the Company' and 'Item 4. Information on the Company—B. Business Overview.' - Discussions of significant changes in the company's business can be found under 'Item 4. Information on the Company—A. History and development of the Company' and 'Item 4. Information on the Company—B. Business Overview'[264] ITEM 9. The Offer and Listing Addresses the company's offering and listing details, plan of distribution, markets where its shares trade, and selling shareholders A. Offering and Listing Details This item is marked as 'Not applicable', indicating no specific offering and listing details are discussed - This item is marked as 'Not applicable'[264] B. Plan of Distribution This item is marked as 'Not applicable', indicating no specific plan of distribution is discussed - This item is marked as 'Not applicable'[265] C. Markets Common shares began trading on OTCQB under 'CYTOF' on December 20, 2024, following delisting from Nasdaq due to non-compliance with the minimum bid price rule - Common shares began trading on OTCQB under the symbol 'CYTOF' on December 20, 2024[266] - The company was delisted from the Nasdaq Capital Market on September 30, 2024, due to failure to comply with the minimum bid price rule ($1.00 per share)[266] D. Selling Shareholders This item is marked as 'Not applicable', indicating no specific selling shareholders are discussed - This item is marked as 'Not applicable'[267] E. Dilution This item is marked as 'Not applicable', indicating no specific dilution information is discussed - This item is marked as 'Not applicable'[268] F. Expenses of the Issue This item is marked as 'Not applicable', indicating no specific expenses of the issue are discussed - This item is marked as 'Not applicable'[269] ITEM 10. Additional Information Provides extensive details on the company's corporate structure, share capital, shareholder rights, Bermuda law comparison with Delaware, material contracts, exchange controls, and tax considerations A. Share Capital This item is marked as 'Not applicable', indicating no specific share capital information is discussed - This item is marked as 'Not applicable'[270] B. Memorandum of Continuance and Bye-Laws Details the company's Bermuda governance, authorized share capital, shareholder rights, dividend policy, board structure, indemnification, and anti-takeover provisions - The company redomesticated from Switzerland to Bermuda in 2019 and is governed by the Companies Act 1981 of Bermuda and its Bye-laws[271] Authorized and Issued Share Capital (as of December 31, 2024) | Share Type | Authorized Shares | Par Value | Issued and Outstanding Shares | | :-------------- | :---------------- | :-------- | :---------------------------- | | Common Shares | 100,000,000 | $0.002 | 4,662,080 | | Preference Shares | 20,000,000 | $0.0001 | 0 | - Holders of common shares have one vote per share, no pre-emptive, redemption, conversion, or sinking fund rights, and share equally in assets upon liquidation[275][276] - Preference shares can be established and issued by the board of directors without further shareholder approval, potentially discouraging control attempts[277] - Dividends are subject to Bermuda law, requiring reasonable grounds to believe the company can pay liabilities and assets exceed liabilities after payment[278] - Rights attaching to any class of shares can be varied with 75% written consent or a majority vote at a class meeting[279] - The board may refuse to register transfers of shares that are not fully paid and can approve reverse share splits by consolidating common shares[280][281] - Annual general meetings are required, with at least 14 days' notice, and a quorum of two or more persons representing issued and outstanding common shares[282][283] - Public documents (memorandum, bye-laws, minutes, audited financials) are available for inspection, but Bermuda law does not provide a general right for shareholders to inspect other corporate records[284] - Directors are elected for one-year terms and can be removed for cause by shareholders with proper notice[285][287] - Board remuneration is determined by the board, and directors can vote on contracts in which they have an interest if disclosed[289][290] - Indemnification for officers and directors is provided, except for fraud or dishonesty, and the company maintains a D&O liability policy[291][292] - Amendments to the Memorandum of Continuance and Bye-laws require board and shareholder resolutions, with certain Bye-laws requiring a 66 2/3% affirmative vote[293] - Amalgamations, mergers, and certain business combinations require board and shareholder approval, with supermajority votes (66 2/3%) for unapproved business combinations with 'interested shareholders' (15% or more beneficial ownership)[295][297] - Bermuda law allows for compulsory acquisition of minority shares under schemes of arrangement or tender offers if certain thresholds (e.g., 75% or 90%) are met[298][299][300] - Anti-takeover provisions include a two-thirds supermajority shareholder voting requirement for certain amalgamations/mergers and specific limitations on director nominations[301][302][303] - Class actions and derivative actions are generally not available to shareholders under Bermuda law, but shareholders can apply to the Supreme Court for relief in cases of oppressive conduct[304][305] - The board of directors may capitalize profits and reserves by issuing fully paid bonus shares[307] - The Bermuda Monetary Authority's permission is required for certain share issuances and transfers to/from non-residents, particularly if beneficial ownership thresholds (10% or 50%) are crossed[308][312][313] - A comparison of corporate law highlights differences between Delaware and Bermuda regarding mergers, shareholder suits, board/management compensation, board renewal, indemnification, fiduciary duties, shareholder consent/proposals, cumulative voting, interested shareholder transactions, dissolution, variation of share rights, amendment of governing documents, inspection of books, dividend payment, and creation/issuance of new shares[316][317][318][319][320][321][324][325][326][327][329][332][335][336][337][342][343][347][348][352][353][356][357][360][361][365][367][370][374][376] C. Material Contracts The company has not been party to any material contracts in the last two years, other than those in the ordinary course of business - The company has not been party to any material contract in the last two years, other than those in the ordinary course of business, except as otherwise disclosed[377] D. Exchange Controls The company is a non-resident for Bermuda exchange control, allowing unrestricted fund transfers, but certain share issuances and transfers to/from non-residents require Bermuda Monetary Authority permission - The company is designated as a non-resident for Bermuda exchange control purposes, allowing transactions in non-Bermuda dollar currencies and unrestricted fund transfers[378] - Prior permission from the Bermuda Monetary Authority is required for certain share issuances and transfers to/from non-residents, particularly if beneficial ownership reaches or exceeds 10% or 50%[379][380] E. Taxation Bermuda imposes no income or capital gains taxes; U.S. Holders face specific federal income tax rules, with the company not anticipating PFIC classification - Bermuda currently imposes no income, profits, withholding, capital gains, capital transfer, estate duty, or inheritance tax on the company or its shareholders[382] - For U.S. Holders, special U.S. federal income tax rules apply, and the company does not anticipate being classified as a Passive Foreign Investment Company (PFIC) for 2024 or the foreseeable future, though PFIC status is an annual factual determination and can be volatile[383][389][390] - Distributions on common shares are expected to be treated as foreign-source dividends for U.S. federal income tax purposes[392] - Gain or loss on the sale or disposition of common shares will be capital gain or loss, generally U.S.-source, subject to PFIC rules[393] - Information reporting and backup withholding rules apply to payments made within the U.S. or through U.S.-related financial intermediaries[394][395] - Certain U.S. Holders may be required to report information relating to an interest in foreign financial assets, including common shares[396] F. Dividends and Paying Agents This item is marked as 'Not applicable', indicating no specific information on dividends and paying agents - This item is marked as 'Not applicable'[398] G. Statement by Experts This item is marked as 'Not applicable', indicating no specific statements by experts - This item is marked as 'Not applicable'[399] H. Documents on Display The company files reports with the SEC and, as a foreign private issuer, is exempt from certain U.S. proxy rules and frequent periodic reports - The company is subject to Exchange Act informational requirements and files reports with the SEC, available at www.sec.gov[400](index=400&type=chunk) - As a foreign private issuer, the company is exempt from U.S. proxy rules, Section 16 reporting, and frequent periodic reports compared to U.S. domestic companies[402] - Under Bermuda law, shareholders can inspect the company's bye-laws, minutes of general meetings, and audited financial statements[401] I. Subsidiary Information This item is marked as 'Not applicable', indicating no specific subsidiary information - This item is marked as 'Not applicable'[403] J. Annual Report to Security Holders This item is marked as 'Not applicable', indicating no specific annual report to security holders information - This item is marked as 'Not applicable'[404] ITEM 11. Quantitative and Qualitative Disclosures About Market Risk Details the company's exposure to credit, market, and currency risks, outlining management strategies such as investing in low-risk instruments and maintaining foreign currency cash balances - The company manages credit risk on a group basis, investing funds in low-risk instruments and holding deposits with independent banks with a minimum S&P rating of 'A'[405] - The company is exposed to market risks, including foreign exchange rate fluctuations, which are assessed and mitigated to minimize adverse effects on financial performance[407] - Currency risk arises from international operations, primarily with respect to the US Dollar and Euro, managed by maintaining foreign currency cash balances to cover anticipated purchases[408] - The company does not hedge its foreign exchange risk[408] ITEM 12. Description of Securities Other Than Equity Securities This item is marked as 'Not applicable', indicating no specific description of securities other than equity securities - This item is marked as 'Not applicable' for Debt securities, Warrants and rights, Other securities, and American Depositary Shares[410][411][412][413] PART II Covers defaults, modifications to security holder rights, controls and procedures, audit committee expertise, code of ethics, accountant fees, and cybersecurity disclosures ITEM 13. Defaults, Dividend Arrearages and Delinquencies This section reports no defaults, dividend arrearages, or delinquencies - No matters to report regarding defaults[415] - No matters to report regarding arrears and delinquencies[416] ITEM 14. Material Modifications to the Rights of Security Holders and Use of Proceeds This item is marked as 'Not applicable', indicating no material modifications to security holder rights or use of proceeds - This item is marked as 'Not applicable' for Use of Proceeds[417] ITEM 15. Controls and Procedures Details the effectiveness of disclosure controls and management's internal control report, highlighting remediation of material weaknesses in 2024 A. Disclosure Controls and Procedures As of December 31, 2024, management concluded that the company's disclosure controls and procedures were effective, with material weaknesses remediated - As of December 31, 2024, the company's disclosure controls and procedures were evaluated as effective[419] - Material weaknesses in internal control over financial reporting identified as of December 31, 2022, and 2023, were remediated in 2024[420] B. Management's Annual Report on Internal Control over Financial Reporting Management concluded that internal control over financial reporting was effective as of December 31, 2024, after remediating material weaknesses through increased finance staff and enhanced control activities - Management concluded that internal control over financial reporting was effective as of December 31, 2024, based on the COSO Framework[421] - Material weaknesses identified in 2022 and 2023 were due to a lack of sufficient resources to execute control activities, leading to potential material errors[423] - Remediation measures in 2024 included hiring a Head of Finance, implementing an effective risk assessment process, reporting to the Audit Committee, enhancing control activities, designing information communication controls, and investing in personnel training[424][425] C. Attestation Report of the Registered Public Accounting Firm This item is marked as 'Not applicable', as the company is a non-accelerated filer and its independent registered public accounting firm is not required to attest to the effectiveness of internal controls - This item is marked as 'Not applicable'[426] D. Changes in Internal Control over Financial Reporting No material changes in internal control over financial reporting occurred during 2024, other than the remediation efforts described in Item 15.B - No material changes in internal control over financial reporting occurred during 2024, other than the remediation efforts described in Item 15.B[427] ITEM 16. [Reserved] This item is marked as 'Reserved', indicating no content is provided for this section - This item is marked as 'Reserved'[428] ITEM 16A. Audit Committee Financial Expert Mats Blom has been determined by the board of directors to be the audit committee financial expert and is independent for SEC purposes - Mats Blom is the audit committee financial expert, as defined by the SEC, and is independent[428] ITEM 16B. Code of Ethics The company has adopted a Code of Business Conduct and Ethics, applicable to all directors, executive officers, and employees, covering conflicts of interest, compliance, and insider trading - The company has adopted a Code of Business Conduct and Ethics applicable to all directors, executive officers, and employees[429] - The Code covers conflicts of interest, compliance, insider trading, and equal opportunity, and is published on the company's website[429] ITEM 16C. Principal Accountant Fees and Services In 2024, total fees for principal accountant services amounted to $663,000, an increase from $578,000 in 2023, including audit and audit-related fees Principal Accountant Fees and Services (in US$ 1,000) | In US$ 1,000 | 2024 | 2023 | | :----------- | :--- | :--- | | Audit fees | 505 | 302 | | Audit related fees | 158 | 276 | | Total fees | 663 | 578 | - In 2024, BDO AG billed $474,750 for audit services and $38,555 for audit-related services[430] - In 2024, former auditors Deloitte AG billed $30,293 for audit services and $119,740 for audit-related services[431] - All non-audit services provided by external auditors are pre-approved by the Audit Committee to ensure independence and objectivity[432] ITEM 16D. Exemptions from the Listing Standards for Audit Committees This item is marked as 'Not applicable', indicating no exemptions from listing standards for audit committees - This item is marked as 'Not applicable'[433] ITEM 16E. Purchases of Equity Securities by the Issuer and Affiliated Purchasers In 2024, no purchases of equity securities were made by or on behalf of Altamira Therapeutics Ltd. or any affiliated purchaser - In 2024, no purchases of equity securities were made by or on behalf of Altamira Therapeutics Ltd. or any affiliated purchaser[434] ITEM 16F. Change in Registrant's Certifying Accountant This item is marked as 'Not applicable', indicating no change in the registrant's certifying accountant - This item is marked as 'Not applicable'[435] ITEM 16G. Corporate Governance This item is marked as 'Not applicable', indicating no specific corporate governance information is discussed - This item is marked as 'Not applicable'[436] ITEM 16H. Mine Safety Disclosure This item is marked as 'Not applicable', indicating no mine safety disclosure - This item is marked as 'Not applicable'[437] ITEM 16I. Disclosure Regarding Foreign Jurisdictions that Prevent Inspections This item is marked as 'Not applicable', indicating no foreign jurisdictions prevent inspections - This item is marked as 'Not applicable'[438] ITEM 16J. Disclosure Regarding Insider Trading Policy The company has adopted a written insider trading policy ('Trading Company Securities Policy') to ensure compliance with applicable insider trading laws and regulations for directors, senior management, and employees - The company has adopted a written insider trading policy ('Trading Company Securities Policy') to promote compliance with insider trading laws for directors, senior management, and employees[439] ITEM 16K. Disclosure Regarding Cybersecurity The company relies on information systems and manages cybersecurity risks through third-party services, security by design, surveillance, incident response, and staff training - The company depends on information systems for operations and is exposed to cybersecurity risks[440] - Risk management includes specialized third-party service providers, security by design (firewalls, intrusion detection, anti-malware), proactive surveillance, incident response plans, and staff training[441][444] - To date, no cybersecurity threats or incidents have materially affected the company's business strategy, results of operations, or financial condition[442] - The Board of Directors oversees cybersecurity risk management, conducting comprehensive risk assessments at least annually, with senior management reporting on risks and trends[443] - The Head of Finance and Administration is responsible for overseeing information systems and cybersecurity risks, assessing and managing them, and communicating to Executive Management and the Board[445] PART III Contains the audited consolidated financial statements for Altamira Therapeutics Ltd. and Altamira Medica AG, along with a list of exhibits ITEM 17. Financial Statements This item indicates that the financial statements are provided under Item 18 - The financial statements are presented under Item 18[447] ITEM 18. Financial Statements Includes audited consolidated financial statements for Altamira Therapeutics Ltd. and subsidiaries for 2022-2024, prepared under IFRS, highlighting going concer