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What changed in Apollomics Inc.'s 20-F — 2023 vs 2024

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Paragraph-level year-over-year comparison of Apollomics Inc.'s 2023 and 2024 20-F annual filings, covering the Business, Risk Factors, Legal Proceedings, Cybersecurity, MD&A and Market Risk sections. Every new, removed and edited paragraph is highlighted side-by-side so you can see exactly what management changed in the 2024 report.

+573 added−908 removedSource: 20-F (2025-04-03) vs 20-F (2023-12-31)

Top changes in Apollomics Inc.'s 2024 20-F

573 paragraphs added · 908 removed · 464 edited across 6 sections

Item 2. Properties

Properties — owned and leased real estate

1 edited+0 added−0 removed0 unchanged
Biggest changeITEM 2. OFFER STATISTICS AND EXPECTED TIMETABLE 3 ITEM 3. KEY INFORMATION 3 A. [RESERVED] 3 B. CAPITALIZATION AND INDEBTEDNESS 3 C. REASONS FOR THE OFFER AND USE OF PROCEEDS 3 D. RISK FACTORS 3 ITEM 4. INFORMATION ON THE COMPANY. 51 A. HISTORY AND DEVELOPMENT OF THE COMPANY 51 B. BUSINESS OVERVIEW 52 C. ORGANIZATIONAL STRUCTURE 106 D.
Biggest changeITEM 2. OFFER STATISTICS AND EXPECTED TIMETABLE 4 ITEM 3. KEY INFORMATION 4 A. [RESERVED] 4 B. CAPITALIZATION AND INDEBTEDNESS 4 C. REASONS FOR THE OFFER AND USE OF PROCEEDS 4 D. RISK FACTORS 4 ITEM 4. INFORMATION ON THE COMPANY. 48 A. HISTORY AND DEVELOPMENT OF THE COMPANY 48 B. BUSINESS OVERVIEW 48 C. ORGANIZATIONAL STRUCTURE 86 D.

Item 3. Legal Proceedings

Legal Proceedings — active lawsuits and investigations

169 edited+40 added−126 removed591 unchanged
Biggest changeRisks Related to Government Regulations • All material aspects of the R&D and commercialization of pharmaceutical products are heavily regulated. • The regulatory approval processes of the FDA, NMPA and other comparable regulatory authorities are lengthy, time-consuming and inherently unpredictable. • For any current and future clinical trials for our product candidates outside the home jurisdiction, the FDA, NMPA, EMA, and applicable foreign regulatory authorities may not accept data from such trials. • Even if we are able to commercialize any approved product candidates, the product candidates may become subject to national or other third-party reimbursement practices or unfavorable pricing regulations. • Any of our future approved product candidates will be subject to ongoing or additional regulatory obligations and continued regulatory review, which may result in significant additional expense, and we may be subject to penalties if we fail to comply with regulatory requirements or experience unanticipated problems with our product candidates. • We may in the future seek orphan drug designation for our product candidates, but we may be unable to obtain orphan drug designation and, even if we obtain such designation, as we have done with vebreltinib, we may not be able to realize or maintain the benefits of such designation, including potential marketing exclusivity of our product candidates, if approved.
Biggest changeRisks Related to Government Regulations • All material aspects of the R&D and commercialization of pharmaceutical products are heavily regulated. • The regulatory approval processes of the FDA, NMPA and other comparable regulatory authorities are lengthy, time-consuming and inherently unpredictable. • For any current and future clinical trials for our product candidates outside the home jurisdiction, the FDA, NMPA, EMA, and applicable foreign regulatory authorities may not accept data from such trials. • We may in the future seek orphan drug designation for our product candidates, but we may be unable to obtain orphan drug designation and, even if we obtain such designation, as we have done with vebreltinib, we may not be able to realize or maintain the benefits of such designation, including potential marketing exclusivity of our product candidates, if approved.
Risks Related to Our Business We are a pre-revenue biotechnology company with a history of losses and will need additional capital to meet our operating cash requirements. We anticipate that we will continue to incur net losses and net operating cash outflows for the foreseeable future and may never achieve or maintain profitability.
Risks Related to Our Business We are a pre-revenue biotechnology company with a history of losses and will need additional capital to meet our operating cash requirements. We anticipate that we will continue to incur net losses and net operating cash outflows for the foreseeable future and may never achieve or maintain profitability.
Regardless of the merits or eventual outcome, liability claims may result in significant negative consequences to our business and prospects, including, but not limited to, harm our reputation, withdrawal of other clinical trial participants, the incurrence of costs to defend the related litigation, the diversion of our management’s time and resources, the requirement to pay substantial monetary awards to trial participants or patients, our inability to commercialize our product candidates; the loss of revenue and the decline of the price of our securities.
Regardless of the merits or eventual outcome, liability claims may result in significant negative consequences to our business and prospects, including, but not limited to, harm to our reputation, withdrawal of other clinical trial participants, the incurrence of costs to defend the related litigation, the diversion of our management’s time and resources, the requirement to pay substantial monetary awards to trial participants or patients, our inability to commercialize our product candidates, the loss of revenue and the decline of the price of our securities.
Risks Related to Our Operations in China Government control of currency conversion of and regulations on investment in PRC entities by offshore holding companies may delay us from making transfers to us from our PRC subsidiaries, or additional contributions to our PRC subsidiaries, which could restrict our ability to fund and expand our business.
Risks Related to Our Operations in China • Government control of currency conversion and regulations on investment in PRC entities by offshore holding companies may delay us from making transfers to us from our PRC subsidiaries, or additional contributions to our PRC Subsidiaries, which could restrict our ability to fund and expand our business.
Because some of our operations are conducted in China, our business is subject to a certain degree of complex and rapidly evolving laws and regulations there.
Because some of our operations are conducted in China, our business is subject to a certain degree of complex and rapidly evolving laws and regulations there.
This evaluation would require new testing and cGMP-compliance inspections by FDA, NMPA or other comparable regulatory authorities. We currently rely on CMOs outside the United States.
This evaluation would require new testing and cGMP-compliance inspections by the FDA, NMPA or other comparable regulatory authorities. We currently rely on CMOs outside the United States.
Even if we apply for and obtain breakthrough therapy, fast track or other designation intended to expedite, facilitate or reduce the cost pursuing development or regulatory review or approval with the FDA or other regulatory authorities for any of our product candidates, there is no guarantee that such designation would lead to faster development, regulatory review, or approval, nor would it increase the likelihood that any such product candidate will receive marketing approval.
Even if we apply for and obtain breakthrough therapy, fast track or other designation intended to expedite, facilitate or reduce the cost of pursuing development or regulatory review or approval with the FDA or other regulatory authorities for any of our product candidates, there is no guarantee that such designation would lead to faster development, regulatory review or approval, nor would it increase the likelihood that any such product candidate will receive marketing approval.
Further, even if any of our products obtain fast track or breakthrough therapy designation, this may not lead to earlier regulatory approval or commercialization of our products due to the extensive and time-consuming steps necessary to obtain approval from FDA or other regulatory authorities and commercialize a product candidate.
Further, even if any of our products obtain fast track or breakthrough therapy designation, this may not lead to earlier regulatory approval or commercialization of our products due to the extensive and time-consuming steps necessary to obtain approval from the FDA or other regulatory authorities and commercialize a product candidate.
Our operating results may fluctuate significantly in the future due to a variety of factors, many of which are outside of our control and may be difficult to predict, including the following: • the timing and success or failure of clinical trials for our product candidates or competing product candidates, or any other change in the competitive landscape of our industry; • our ability to successfully recruit and retain patients for clinical trials, and any delays caused by difficulties in such efforts; • our ability to obtain approval from relevant authorities for development and commercialization of our product candidates, and the timing and scope of any such approvals we may receive; • the timing, the cost of, and level of investment in, R&D activities relating to our product candidates, which may change from time to time; • the cost of manufacturing our product candidates, which may vary depending on the quantity of production and the terms of our agreements with manufacturers; • our ability to attract, hire and retain qualified personnel; • expenditures that we will or may incur to develop additional product candidates; • the level of demand for our product candidates should they receive approval, which may vary significantly; • the risk/benefit profile, cost and reimbursement policies with respect to our product candidates, if approved, and existing and potential future therapeutics that compete with our product candidates; • general market conditions or extraordinary external events, such as a recession; • the changing and volatile United States and global economic environments; and • future accounting pronouncements or changes in our accounting policies.
Our operating results may fluctuate significantly in the future due to a variety of factors, many of which are outside of our control and may be difficult to predict, including the following: • the timing and success or failure of clinical trials for our product candidates or competing product candidates, or any other change in the competitive landscape of our industry; • our ability to successfully recruit and retain patients for clinical trials, and any delays caused by difficulties in such efforts; • our ability to obtain approval from relevant authorities for development and commercialization of our product candidates, and the timing and scope of any such approvals we may receive; • the timing, the cost of, and level of investment in, R&D activities relating to our product candidates, which may change from time to time; • the cost of manufacturing our product candidates, which may vary depending on the quantity of production and the terms of our agreements with manufacturers; • our ability to attract, hire and retain qualified personnel; • expenditures that we will or may incur to develop additional product candidates; • the level of demand for our product candidates should they receive approval, which may vary significantly; • the risk/benefit profile, cost and reimbursement policies with respect to our product candidates, if approved, and existing and potential future therapeutics that compete with our product candidates; • general market conditions or extraordinary external events, such as a recession; • the changing and volatile United States and global economic and political environments; and • future accounting pronouncements or changes in our accounting policies.
Risks Related to Ownership of Our Securities • There can be no assurance that we will be able to comply with the continued listing standards of Nasdaq or any other exchange. • The trading price of our securities has been and is likely to continue to be volatile, which could result in substantial losses to holders of our securities. • We are now incurring significant increased expenses and administrative burdens now that we are a public company. • In the course of auditing the consolidated financial statements for the year ended December 31, 2023, we identified one material weakness and three significant deficiencies in our internal control over financial reporting as of December 31, 2023.
Risks Related to Ownership of Our Securities • There can be no assurance that we will be able to comply with the continued listing standards of Nasdaq or any other exchange. • The trading price of our securities has been and is likely to continue to be volatile, which could result in substantial losses to holders of our securities. • We are incurring significant increased expenses and administrative burdens as a public company. • In the course of auditing the consolidated financial statements for the year ended December 31, 2023, we identified one material weakness and three significant deficiencies in our internal control over financial reporting as of December 31, 2023.
Furthermore, collaborations involving our product candidates are subject to the following risks: • collaboration partners have significant discretion in determining the efforts and resources that they will apply to a collaboration; • collaboration partners may not pursue development and commercialization of our product candidates or may elect not to continue or renew development or commercialization programs based on clinical trial results, changes in their strategic focus due to the acquisition of competitive drugs, availability of funding or other external factors, such as a business combination that diverts resources or creates competing priorities; • collaboration partners may delay clinical trials, provide insufficient funding for a clinical trial, stop a clinical trial, abandon a product candidate, repeat or conduct new clinical trials or require a new formulation of a product candidate for clinical testing; • collaboration partners could independently develop, or develop with third parties, drugs that compete directly or indirectly with our product candidates; • a collaboration partner with marketing and distribution rights to one or more of our product candidates may not commit sufficient resources to their marketing and distribution; • we could grant exclusive rights to our collaboration partners that would prevent us from collaborating with others; • collaboration partners may not properly obtain, protect, maintain, defend or enforce our intellectual property rights or may use our intellectual property or proprietary information in a way that gives rise to actual or threatened litigation that could jeopardize or invalidate our intellectual property rights or proprietary information or expose us to potential liability; • collaboration partners may not aggressively or adequately pursue litigation against generic filers or may settle such litigation on unfavorable terms, as they may have different economic interests than ours, and such decisions could negatively impact any royalties we may receive under our license agreements; • collaborations may be terminated and, if terminated, may result in a need for additional capital to pursue further development or commercialization of the applicable product candidates; • collaboration partners may own or co-own intellectual property covering our product candidates that results from our collaborating with them, and in such cases, we could potentially not have the exclusive right to commercialize such intellectual property; • we may co-own with collaboration partners, and therefore not have complete control over, some of our intellectual property and, in the ordinary course of business, we may license our rights under such co-owned intellectual property to third parties, which may lead to disputes with the relevant co-owner of such intellectual property; and • a collaboration partner’s sales and marketing activities or other operations may not be in compliance with applicable laws resulting in civil, administrative, or criminal proceedings.
Furthermore, collaborations involving our product candidates are subject to the following risks: • collaboration partners have significant discretion in determining the efforts and resources that they will apply to a collaboration; 23 Table of Contents • collaboration partners may not pursue development and commercialization of our product candidates or may elect not to continue or renew development or commercialization programs based on clinical trial results, changes in their strategic focus due to the acquisition of competitive drugs, availability of funding or other external factors, such as a business combination that diverts resources or creates competing priorities; • collaboration partners may delay clinical trials, provide insufficient funding for a clinical trial, stop a clinical trial, abandon a product candidate, repeat or conduct new clinical trials or require a new formulation of a product candidate for clinical testing; • collaboration partners could independently develop, or develop with third parties, drugs that compete directly or indirectly with our product candidates; • a collaboration partner with marketing and distribution rights to one or more of our product candidates may not commit sufficient resources to their marketing and distribution; • we could grant exclusive rights to our collaboration partners that would prevent us from collaborating with others; • collaboration partners may not properly obtain, protect, maintain, defend or enforce our intellectual property rights or may use our intellectual property or proprietary information in a way that gives rise to actual or threatened litigation that could jeopardize or invalidate our intellectual property rights or proprietary information or expose us to potential liability; • collaboration partners may not aggressively or adequately pursue litigation against generic filers or may settle such litigation on unfavorable terms, as they may have different economic interests than ours, and such decisions could negatively impact any royalties we may receive under our license agreements; • collaborations may be terminated and, if terminated, may result in a need for additional capital to pursue further development or commercialization of the applicable product candidates; • collaboration partners may own or co-own intellectual property covering our product candidates that results from our collaborating with them, and in such cases, we could potentially not have the exclusive right to commercialize such intellectual property; • we may co-own with collaboration partners, and therefore not have complete control over, some of our intellectual property and, in the ordinary course of business, we may license our rights under such co-owned intellectual property to third parties, which may lead to disputes with the relevant co-owner of such intellectual property; and • a collaboration partner’s sales and marketing activities or other operations may not be in compliance with applicable laws resulting in civil, administrative, or criminal proceedings.
The following examples are illustrative: • Pending patent applications that we own or may license may not lead to issued patents; • Patents, should they issue, that we own or may license, may not provide us with any competitive advantages, or may be challenged and held invalid or unenforceable; • Others may be able to develop and/or practice technology that is similar to our technology or aspects of our technology but that is not covered by the claims of any patents that we own or may license, should any such patents issue; • Third parties may compete with us in jurisdictions where we do not pursue and obtain patent protection; • We (or any licensors) might not have been the first to make the inventions covered by a pending patent application that we own or may license; • We (or any licensors) might not have been the first to file patent applications covering a particular invention; • Others may independently develop similar or alternative technologies without infringing our intellectual property rights; • We may not be able to obtain necessary licenses on reasonable terms or at all; • Third parties may assert an ownership interest in our intellectual property and, if successful, such disputes may preclude us from exercising exclusive rights, or any rights at all, over that intellectual property; • We may need to initiate litigation or administrative proceedings to enforce and/or defend our patent rights, which will be costly whether we win or lose; • We may not be able to maintain the confidentiality of our trade secrets or other proprietary information; 43 Table of Contents • We may not develop or in-license additional proprietary technologies that are not patentable; and • The patents of others may have an adverse effect on our business.
The following examples are illustrative: • pending patent applications that we own or may license may not lead to issued patents; • patents, should they issue, that we own or may license, may not provide us with any competitive advantages, or may be challenged and held invalid or unenforceable; • others may be able to develop and/or practice technology that is similar to our technology or aspects of our technology but that is not covered by the claims of any patents that we own or may license, should any such patents issue; • third parties may compete with us in jurisdictions where we do not pursue and obtain patent protection; • we (or any licensors) might not have been the first to make the inventions covered by a pending patent application that we own or may license; • we (or any licensors) might not have been the first to file patent applications covering a particular invention; • others may independently develop similar or alternative technologies without infringing our intellectual property rights; • we may not be able to obtain necessary licenses on reasonable terms or at all; • third parties may assert an ownership interest in our intellectual property and, if successful, such disputes may preclude us from exercising exclusive rights, or any rights at all, over that intellectual property; • we may need to initiate litigation or administrative proceedings to enforce and/or defend our patent rights, which will be costly whether we win or lose; • we may not be able to maintain the confidentiality of our trade secrets or other proprietary information; 41 Table of Contents • we may not develop or in-license additional proprietary technologies that are not patentable; and • the patents of others may have an adverse effect on our business.
Moreover, international business relationships subject us to additional risks that may materially adversely affect our ability to attain or sustain profitable operations, including: • efforts to enter into collaboration or licensing arrangements with third parties in connection with our international sales, marketing and distribution efforts may increase our expenses or divert our management’s attention from the acquisition or development of product candidates; • changes in a specific country’s or region’s political and cultural climate or economic condition; • differing regulatory requirements for drug approvals and marketing internationally; • difficulty of effective enforcement of contractual provisions in local jurisdictions; • potentially reduced protection for intellectual property rights; • potential third-party patent rights; • unexpected changes in tariffs, trade barriers and regulatory requirements; • economic weakness, including inflation or political instability; • compliance with tax, employment, immigration and labor laws for employees traveling abroad; • the effects of applicable tax structures and potentially adverse tax consequences; • currency fluctuations, which could result in increased operating expenses and reduced revenue, and other obligations incidental to doing business in another country; • workforce uncertainty and labor unrest; • the potential for so-called parallel importing, which is what happens when a local seller, faced with high or higher local prices, opts to import goods from an international market with low or lower prices rather than buying them locally; • failure of our employees and contracted third parties to comply with Office of Foreign Assets Control rules and regulations and the Foreign Corrupt Practices Act of the United States, and other applicable rules and regulations; • production shortages resulting from any events affecting raw material supply or manufacturing capabilities abroad; and • business interruptions resulting from geo-political actions, including war and terrorism, or natural disasters, including earthquakes, volcanoes, typhoons, floods, hurricanes and fires.
Moreover, international business relationships subject us to additional risks that may materially adversely affect our ability to attain or sustain profitable operations, including: • efforts to enter into collaboration or licensing arrangements with third parties in connection with our international sales, marketing and distribution efforts may increase our expenses or divert our management’s attention from the acquisition or development of product candidates; • changes in a specific country’s or region’s political and cultural climate or economic condition; • differing regulatory requirements for drug approvals and marketing internationally; • difficulty of effective enforcement of contractual provisions in local jurisdictions; • potentially reduced protection for intellectual property rights; • potential third-party patent rights; • unexpected changes in tariffs, trade barriers and regulatory requirements; • economic weakness, including inflation or political instability; • compliance with tax, employment, immigration and labor laws for employees traveling abroad; • the effects of applicable tax structures and potentially adverse tax consequences; • currency fluctuations, which could result in increased operating expenses and reduced revenue, and other obligations incidental to doing business in another country; • workforce uncertainty and labor unrest; • the potential for so-called parallel importing, which is what happens when a local seller, faced with high or higher local prices, opts to import goods from an international market with low or lower prices rather than buying them locally; • failure of our employees and contracted third parties to comply with Office of Foreign Assets Control rules and regulations and the Foreign Corrupt Practices Act of the United States, and other applicable rules and regulations; 20 Table of Contents • production shortages resulting from any events affecting raw material supply or manufacturing capabilities abroad; and • business interruptions resulting from geo-political actions, including war and terrorism, or natural disasters, including earthquakes, volcanoes, typhoons, floods, hurricanes and fires.
If unacceptable side effects arise in the development of our product candidates, we, the FDA, NMPA, or comparable regulatory authorities, the Institutional Review Boards (the “IRBs”), data and safety monitory boards or independent ethics committees at the institutions in which the trials on our product candidates are conducted could suspend or terminate our preclinical studies or clinical trials or the FDA, NMPA or comparable regulatory authorities could order us to cease preclinical studies or clinical trials or deny approval of our product candidates for any or all indications we are pursuing.
If unacceptable side effects arise in the development of our product candidates, we, the FDA or comparable regulatory authorities, the Institutional Review Boards (the “IRBs”), data and safety monitory boards or independent ethics committees at the institutions in which the trials on our product candidates are conducted could suspend or terminate our preclinical studies or clinical trials or the FDA or comparable regulatory authorities could order us to cease preclinical studies or clinical trials or deny approval of our product candidates for any or all indications we are pursuing.
Even though the FDA, NMPA and other comparable regulatory authorities actively enforce the laws and regulations prohibiting the promotion of off-label use, there remains the risk that our product is subject to off-label drug use and is prescribed in a patient population, dosage or dosage form that has not been approved by competent authorities.
Even though the FDA and other comparable regulatory authorities actively enforce the laws and regulations prohibiting the promotion of off-label use, there remains the risk that our product is subject to off-label drug use and is prescribed in a patient population, dosage or dosage form that has not been approved by competent authorities.
If the FDA, NMPA, EMA, or any applicable foreign regulatory authority does not accept such data, it may result in the need for additional trials, which would be costly and time-consuming and delay aspects of our business plan, and may result in our product candidates not receiving approval or clearance for commercialization in the applicable jurisdiction.
If the FDA, EMA, or any applicable foreign regulatory authority does not accept such data, it may result in the need for additional trials, which would be costly and time-consuming and delay aspects of our business plan, and may result in our product candidates not receiving approval or clearance for commercialization in the applicable jurisdiction.
However, there can be no assurance that the Company will be able to regain compliance with the Bid Price Requirement or maintain compliance with any of the other Nasdaq continued listing requirements. The trading price of our securities has been and is likely to continue to be volatile, which could result in substantial losses to holders of our securities.
However, there can be no assurance that the Company will be able to maintain compliance with the Bid Price Requirement or with any of the other Nasdaq continued listing requirements. The trading price of our securities has been and is likely to continue to be volatile, which could result in substantial losses to holders of our securities.
Competition to hire from this limited pool is intense, and we may be unable to hire, train, retain or motivate these key personnel on acceptable terms given the competition among numerous biopharmaceutical companies for similar personnel. We also experience competition for the hiring of scientific and clinical personnel from universities and research institutions.
Hiring from this limited pool is competitive and intense, and we may be unable to hire, train, retain or motivate these key personnel on acceptable terms given the competition among numerous biopharmaceutical companies for similar personnel. We also experience competition for the hiring of scientific and clinical personnel from universities and research institutions.
In such an event of risk identification of safety risks, our trials could be revised, suspended or terminated by the health authorities, and the FDA, NMPA or comparable regulatory authorities could order us to cease further development of or deny approval of our product candidates for any or all targeted indications.
In such an event of risk identification of safety risks, our trials could be revised, suspended or terminated by the health authorities, and the FDA or comparable regulatory authorities could order us to cease further development of or deny approval of our product candidates for any or all targeted indications.
Any negative publicity concerning us or our affiliates, even if untrue, could adversely affect our reputation and business prospects. We cannot assure you that negative publicity about us or any of our affiliates name would not damage our brand image or have a material adverse effect on our business, results of operations and financial condition.
Any negative publicity concerning us or our affiliates, even if untrue, could adversely affect our reputation and business prospects. We cannot assure you that negative publicity about us or any of our affiliates would not damage our brand image or have a material adverse effect on our business, results of operations and financial condition.
If we lose our status as a foreign private issuer in the future, it will no longer be exempt from the rules described above and, among other things, will be required to file periodic reports and annual and quarterly financial statements as if it were a company incorporated in the United States.
If we lose our status as a foreign private issuer in the future, we will no longer be exempt from the rules described above and, among other things, will be required to file periodic reports and annual and quarterly financial statements as if we were a company incorporated in the United States.
We may issue additional Class A Ordinary Shares or other equity securities of equal or senior rank in the future in connection with, among other things, financings, future acquisitions, repayment of outstanding indebtedness, employee benefit plans and exercises of outstanding options, warrants and other convertible securities, in a number of circumstances.
We may issue additional Class A Ordinary Shares or other equity or equity-linked securities of equal or senior rank in the future in connection with, among other things, financings, future acquisitions, repayment of outstanding indebtedness, employee benefit plans and exercises of outstanding options, warrants and other convertible securities, in a number of circumstances.
For any current and future clinical trials for our product candidates outside the home jurisdiction, the FDA, NMPA, EMA, and applicable foreign regulatory authorities may not accept data from such trials. We conduct clinical trials outside the United States, including in China, Australia and Europe, and we may choose to conduct future clinical trials outside the United States.
For any current and future clinical trials for our product candidates outside the home jurisdiction, the FDA, EMA, and applicable foreign regulatory authorities may not accept data from such trials. We conduct clinical trials outside the United States, including in China, Australia and Europe, and we may choose to conduct future clinical trials outside the United States.
It may be difficult to enforce U.S. judgments against us. We are a holding company incorporated under the laws of the Cayman Islands, and a substantial portion of our assets are outside of the United States. Most of our directors and senior management reside in the United States.
It may be difficult to enforce U.S. judgments against us. We are a holding company incorporated under the laws of the Cayman Islands, and a substantial portion of our assets are outside of the United States. Most of our directors and all of our senior management reside in the United States.
We cannot be certain of the timely completion or outcome of our preclinical testing and studies and cannot predict if the U.S. Food and Drug Administration (the “FDA”), NMPA or other relevant regulatory authorities will accept our proposed clinical programs or if the outcome of our preclinical testing and studies ultimately will support the further development of our programs.
We cannot be certain of the timely completion or outcome of our preclinical testing and studies and cannot predict if the U.S. Food and Drug Administration (the “FDA”) or other relevant regulatory authorities will accept our proposed clinical programs or if the outcome of our preclinical testing and studies ultimately will support the further development of our programs.
Consequently, it is possible that the results of clinical trials on our product candidates may indicate an apparent positive effect of a product candidate to be greater than the actual positive effect, if any, or alternatively fail to identify undesirable side effects.
Consequently, it is possible that the results of clinical trials of our product candidates may indicate an apparent positive effect of a product candidate to be greater than the actual positive effect, if any, or alternatively fail to identify undesirable side effects.
Following any approval for commercial sale of our product candidates, certain changes to the drug, such as changes in manufacturing processes and additional labeling claims, may be subject to additional review and approval by the FDA, NMPA, and comparable regulatory authorities. Also, regulatory approval for any of our product candidates may be withdrawn.
Following any approval for commercial sale of our product candidates, certain changes to the drug, such as changes in manufacturing processes and additional labeling claims, may be subject to additional review and approval by the FDA and comparable regulatory authorities. Also, regulatory approval for any of our product candidates may be withdrawn.
The time required to obtain approval by the FDA, NMPA and other comparable regulatory authorities is unpredictable but typically takes 10–15 years following the commencement of preclinical studies and clinical trials and depends on numerous factors, including the substantial discretion of the regulatory authorities.
The time required to obtain approval by the FDA and other comparable regulatory authorities is unpredictable but typically takes 10–15 years following the commencement of preclinical studies and clinical trials and depends on numerous factors, including the substantial discretion of the regulatory authorities.
Because we have no current plans to pay cash dividends on our Class A Ordinary Shares for the foreseeable future, you may not receive any return on investment unless you sell Class A Ordinary Shares for a price greater than that which you paid for it.
Because we have no current plans to pay cash dividends on our Class A Ordinary Shares for the foreseeable future, you may not receive any return on investment unless you sell Class A Ordinary Shares for a price greater than that which you paid.
The Chinese government may exercise significant oversight and discretion over the conduct of our business in the PRC and may intervene in or influence our operations in China at any time, which could result in a material change in our operations and/or the value of our securities, and may restrict or hinder our ability to offer securities and raise capital outside the PRC. 3 Table of Contents • We and our PRC Subsidiaries may become subject to a variety of laws and regulations regarding cybersecurity and data protection in the PRC, and any failure to comply with applicable laws and regulations could have a material adverse effect on our business, financial condition and results of operations. • Our partners in China may be restricted from transferring their scientific data or drug products for us to use abroad. • We could be adversely affected by a deterioration of trade relations between the United States and China. • The political relationships among Greater China and other countries may affect our business operations. • The implementation of labor laws and regulations in China may adversely affect our business and results of operations.
The Chinese government may exercise significant oversight and discretion over the conduct of our business in the PRC and may intervene in or influence our operations in China at any time, which could result in a material change in our operations and/or the value of our securities, and may restrict or hinder our ability to offer securities and raise capital outside the PRC. • We and our PRC Subsidiaries may become subject to a variety of laws and regulations regarding cybersecurity and data protection in the PRC, and any failure to comply with applicable laws and regulations could have a material adverse effect on our business, financial condition and results of operations. • Our partners in China may be restricted from transferring their scientific data or drug products for us to use abroad. • We could be adversely affected by a deterioration of trade relations between the United States and China. • The political relationships among Greater China and other countries may affect our business operations. • The implementation of labor laws and regulations in China may adversely affect our business and results of operations.
For example, the PRC government has been seeking to exert more control and impose more restrictions on companies based in mainland China raising capital offshore and such efforts may continue or intensify in the future.
For example, the PRC government has been seeking to exert more control over and impose more restrictions on companies based in mainland China raising capital offshore and such efforts may continue or intensify in the future.
The FDA, NMPA or a comparable regulatory authority may require more information, including additional preclinical or clinical data, to support approval, which may delay or prevent approval and our commercialization plans, or we may decide to abandon the development program.
The FDA or a comparable regulatory authority may require more information, including additional preclinical or clinical data, to support approval, which may delay or prevent approval and our commercialization plans, or we may decide to abandon the development program.
Moreover, there may also be third-party patents or patent applications of which we are currently unaware, and given the dynamic area in which we operate, additional patents that relate to our business are likely to be issued. 40 Table of Contents If third parties, including the ones above, bring claims against us for infringement, misappropriation or other violations of their intellectual property rights, we may be subject to injunctive or other equitable relief, which could prevent us from developing and commercializing vebreltinib.
Moreover, there may also be third-party patents or patent applications of which we are currently unaware, and given the dynamic area in which we operate, additional patents that relate to our business are likely to be issued. 38 Table of Contents If third parties, including the ones above, bring claims against us for infringement, misappropriation or other violations of their intellectual property rights, we may be subject to injunctive or other equitable relief, which could prevent us from developing and commercializing vebreltinib.
The market values of our securities may vary significantly from their prices on the date of this Annual Report, and fluctuations in the price of our’ securities could contribute to the loss of all or part of your investment.
The market values of our securities may vary significantly from their prices on the date of this Annual Report, and fluctuations in the price of our securities could contribute to the loss of all or part of your investment.
If such undesirable side effects caused by such product candidates (or any other similar products) are identified at a late stage of development or after marketing approval, a number of potentially significant negative consequences could result, including: • regulatory authorities may withhold, withdraw or limit their approval of such product candidates; • regulatory authorities may require the addition of labeling statements, such as a boxed warning or contraindications; • we may be required to change the way such product candidates are distributed or administered, or change the labeling of the product candidates; 10 Table of Contents • the FDA, NMPA or a comparable regulatory authority may require a risk evaluation and mitigation strategy program to mitigate risks, which could include medication guides, physician communication plans or elements to assure safe use, such as restricted distribution methods, patient registries and other risk minimization tools, and regulatory authorities in other jurisdictions may require comparable risk mitigation plans; • we may be subject to regulatory investigations and government enforcement actions; • the FDA, NMPA or a comparable regulatory authority may require us to conduct additional clinical trials or costly post-marketing testing and surveillance to monitor the safety and efficacy of the product; • we could be sued and held liable for injury caused to individuals exposed to or taking our product candidates; and • our reputation may suffer.
If such undesirable side effects caused by such product candidates (or any other similar products) are identified at a late stage of development or after marketing approval, a number of potentially significant negative consequences could result, including: • regulatory authorities may withhold, withdraw or limit their approval of such product candidates; • regulatory authorities may require the addition of labeling statements, such as a boxed warning or contraindications; • we may be required to change the way such product candidates are distributed or administered, or change the labeling of the product candidates; • the FDA or a comparable regulatory authority may require a risk evaluation and mitigation strategy program to mitigate risks, which could include medication guides, physician communication plans or elements to assure safe use, such as restricted distribution methods, patient registries and other risk minimization tools, and regulatory authorities in other jurisdictions may require comparable risk mitigation plans; • we may be subject to regulatory investigations and government enforcement actions; • the FDA or a comparable regulatory authority may require us to conduct additional clinical trials or costly post-marketing testing and surveillance to monitor the safety and efficacy of the product; • we could be sued and held liable for injury caused to individuals exposed to or taking our product candidates; and • our reputation may suffer.
If the FDA, NMPA or comparable regulatory authority revokes its approval of another therapeutic product we use in combination with our product candidates, we will not be able to market our product candidates in combination with such revoked therapeutic product.
If the FDA or comparable regulatory authority revokes its approval of another therapeutic product we use in combination with our product candidates, we will not be able to market our product candidates in combination with such revoked therapeutic product.
Risks Related to our Intellectual Property Rights • If we are unable to obtain and maintain patent protection for our product candidates through intellectual property rights, or if the scope of such intellectual property rights obtained is not sufficiently broad, or if any patent rights that we own or in-licensed is challenged by third parties, third parties could develop and commercialize products and technologies similar or identical to ours and compete directly against us, and our ability to successfully commercialize any product or technology may be adversely affected. • We enjoy only limited geographical protection with respect to certain patents and may not be able to protect our intellectual property rights throughout the world. • We may not be successful in obtaining or maintaining necessary rights for our development pipeline through acquisitions and in-licenses. 4 Table of Contents • Our rights to develop and commercialize our product candidates are subject, in part, to the terms and conditions of licenses granted to us by others.
Risks Related to our Intellectual Property Rights • If we are unable to obtain and maintain patent protection for our product candidates through intellectual property rights, or if the scope of such intellectual property rights obtained is not sufficiently broad, or if any patent rights that we own or in-licensed is challenged by third parties, third parties could develop and commercialize products and technologies similar or identical to ours and compete directly against us, and our ability to successfully commercialize any product or technology may be adversely affected. • We enjoy only limited geographical protection with respect to certain patents and may not be able to protect our intellectual property rights throughout the world. • We may not be successful in obtaining or maintaining necessary rights for our development pipeline through acquisitions and in-licenses. • Our rights to develop and commercialize our product candidates are subject, in part, to the terms and conditions of licenses granted to us by others.
If we submit a marketing application to the FDA and/or NMPA, the FDA or NMPA decides whether to accept or reject the submission for filing. We cannot be certain that any submissions will be accepted for filing and review by the FDA and/or NMPA.
If we submit a marketing application to the FDA, the FDA decides whether to accept or reject the submission for filing. We cannot be certain that any submissions will be accepted for filing and review by the FDA.
The acceptance of study data from clinical trials conducted outside the United States or another jurisdiction by the FDA, NMPA, EMA, or applicable foreign regulatory authority may be subject to certain conditions.
The acceptance of study data from clinical trials conducted outside the United States or another jurisdiction by the FDA, EMA, or applicable foreign regulatory authority may be subject to certain conditions.
There can be no assurance that the FDA, NMPA, EMA, or any applicable foreign regulatory authority will accept data from trials conducted outside of the United States or the applicable jurisdiction.
There can be no assurance that the FDA, EMA, or any applicable foreign regulatory authority will accept data from trials conducted outside of the United States or the applicable jurisdiction.
If any of our trade secrets were to be disclosed or independently developed by a competitor, we may have no right to prevent them, or others to whom they 37 Table of Contents communicate it, from using that technology or information to compete against us, which may have a material adverse effect on our business, financial condition, results of operations and prospects.
If any of our trade secrets were to be disclosed or independently developed by a competitor, we may have no right to prevent them, or others to whom they 35 Table of Contents communicate it, from using that technology or information to compete against us, which may have a material adverse effect on our business, financial condition, results of operations and prospects.
Our product candidates could fail to receive regulatory approval for many reasons, including: • failure to begin or complete clinical trials due to disagreements with regulatory authorities; • failure to demonstrate that a product candidate is safe and effective or, if it is a biologic, that it is safe, pure, and potent for its proposed indication; 28 Table of Contents • failure of clinical trial results to meet the level of statistical significance required for approval; • failure to demonstrate to the FDA or the NMPA that the objective response rate and duration of response for our product candidates are clinically meaningful; • failure to demonstrate to the FDA or the NMPA that the dose for a product candidate has been optimized; • data integrity issues related to our clinical trials; • disagreement with our interpretation of data from preclinical studies or clinical trials; • regulators may not accept data from our clinical trials completed in foreign jurisdictions if we do not satisfy certain regulatory requirements; • our failure to interpret correctly any guidance received from regulators; • our failure to conduct a clinical trial in accordance with regulatory requirements or our clinical trial protocols; and • clinical sites, investigators or other participants in our clinical trials deviating from a trial protocol, failing to conduct the trial in accordance with regulatory requirements, or dropping out of a trial.
Our product candidates could fail to receive regulatory approval for many reasons, including: • failure to begin or complete clinical trials due to disagreements with regulatory authorities; • failure to demonstrate that a product candidate is safe and effective or, if it is a biologic, that it is safe, pure, and potent for its proposed indication; • failure of clinical trial results to meet the level of statistical significance required for approval; • failure to demonstrate to the FDA that the objective response rate and duration of response for our product candidates are clinically meaningful; • failure to demonstrate to the FDA that the dose for a product candidate has been optimized; • data integrity issues related to our clinical trials; • disagreement with our interpretation of data from preclinical studies or clinical trials; • regulators may not accept data from our clinical trials completed in foreign jurisdictions if we do not satisfy certain regulatory requirements; • our failure to interpret correctly any guidance received from regulators; • our failure to conduct a clinical trial in accordance with regulatory requirements or our clinical trial protocols; and • clinical sites, investigators or other participants in our clinical trials deviating from a trial protocol, failing to conduct the trial in accordance with regulatory requirements, or dropping out of a trial.
If we or any of our PRC Subsidiaries fails to receive any requisite permission or approval from the CAC for future offerings or the business operations of our PRC Subsidiaries, or the waiver for such permission or approval, in a timely manner, or at all, or inadvertently concludes that such permission or approval is not required, or if applicable laws, regulations or interpretations change and obligate us to obtain such permission or approvals in the future, we or our PRC Subsidiaries may be subject to fines, suspension of business, website closure, revocation of business licenses or other penalties, as well as reputational damage or legal proceedings or actions against us, which may have a material 21 Table of Contents adverse effect on our business, financial condition or results of operations.
If we or any of our PRC Subsidiaries fails to receive any requisite permission or approval from the CAC for future offerings or the business operations of our PRC Subsidiaries, or the waiver for such permission or approval, in a timely manner, or at all, or inadvertently concludes that such permission or approval is not required, or if applicable laws, regulations or interpretations change and obligate us to obtain such permission or approvals in the future, we or our PRC Subsidiaries may be subject to fines, suspension of business, website closure, revocation of business licenses or other penalties, as well as reputational damage or legal proceedings or actions against us, which may have a material adverse effect on our business, financial condition or results of operations.
Moreover, we cannot assure you that additional material weaknesses or significant deficiencies in our internal control over financial reporting will not be identified in the future.
We cannot assure you that additional material weaknesses or significant deficiencies in our internal control over financial reporting will not be identified in the future.
Before obtaining regulatory approvals for the commercial sale of any product candidate for a target indication, we must demonstrate in preclinical studies and well-controlled clinical trials, and, with respect to approval in the United States, to the satisfaction of the FDA, with respect to approval in China, to the satisfaction of the NMPA, that the product candidate is safe and effective for use for that target indication and that the manufacturing facilities, processes and controls are adequate.
Before obtaining regulatory approvals for the commercial sale of any product candidate for a target indication, we must demonstrate in preclinical studies and well-controlled clinical trials, and, with respect to approval in the United States, to the satisfaction of the FDA, that the product candidate is safe and effective for use for that target indication and that the manufacturing facilities, processes and controls are adequate.
Our pending and future patent applications may not result in patents being issued which protect our technology or product candidates or which effectively prevent others from commercializing competitive technologies and product candidates. 35 Table of Contents The patent examination process may require us or our licensors to narrow the scope of the claims of our or our licensors’ pending and future patent applications, which may limit the scope of patent protection that may be obtained.
Our pending and future patent applications may not result in patents being issued which protect our technology or product candidates or which effectively prevent others from commercializing competitive technologies and product candidates. 33 Table of Contents The patent examination process may require us or our licensors to narrow the scope of the claims of our or our licensors’ pending and future patent applications, which may limit the scope of patent protection that may be obtained.
If any of our licensors terminate any of our licenses, we might not be able to develop, manufacture 41 Table of Contents or market any drug or product candidate that is covered by the licenses provided for under these agreements and other third parties or our competitors may have freedom to market product candidates similar or identical to ours.
If any of our licensors terminate any of our licenses, we might not be able to develop, manufacture 39 Table of Contents or market any drug or product candidate that is covered by the licenses provided for under these agreements and other third parties or our competitors may have freedom to market product candidates similar or identical to ours.
We qualify as an “emerging growth company” and a foreign private issuer within the meaning of the Securities Act, and if we take advantage of certain exemptions from disclosure requirements available to emerging growth companies and foreign private issuers, it could make our securities less attractive to investors and may make it more difficult to compare our performance to the performance of other public companies.
We qualify as an “emerging growth company” and a foreign private issuer within the meaning of the Securities Act, and we take advantage of certain exemptions from disclosure requirements available to emerging growth companies and foreign private issuers that could make our securities less attractive to investors and may make it more difficult to compare our performance to the performance of other public companies.
As a result, assuming that we are able to obtain regulatory approvals for vebreltinib, uproleselan , APL-501, APL-102 or other existing or any future product candidate that we may develop in the future, we cannot assure you that they will be able to achieve commercial success, whether due to established first-entrants or otherwise.
As a result, assuming that we are able to obtain regulatory approvals for vebreltinib, APL-102 or other existing or any future product candidate that we may develop in the future, we cannot assure you that they will be able to achieve commercial success, whether due to established first-entrants or otherwise.
If we are unable to successfully obtain rights to required third-party intellectual property 39 Table of Contents rights or maintain the existing intellectual property rights we have, we may have to abandon development of the relevant program or product candidate, which could materially adversely affect our business, financial condition, results of operations and prospects.
If we are unable to successfully obtain rights to required third-party intellectual property 37 Table of Contents rights or maintain the existing intellectual property rights we have, we may have to abandon development of the relevant program or product candidate, which could materially adversely affect our business, financial condition, results of operations and prospects.
We may experience numerous unforeseen events during, or as a result of, clinical trials, that could delay or prevent our ability to receive marketing approval or commercialize our product candidates, including: • we may experience delays in reaching, or may fail to reach, a consensus with regulators on trial design; • the supply or quality of our product candidates or other materials necessary to conduct clinical trials of our product candidates may be insufficient or inadequate, including as a result of delays in the testing, validation, manufacturing and delivery of product candidates to the clinical sites by us or by third parties with whom we have contracted to perform certain of those functions; • we may experience delays in reaching, or may fail to reach, agreement on acceptable clinical trial contracts or clinical trial protocols with prospective trial sites; • regulators or institutional review boards may not authorize us or our investigators to commence a clinical trial or conduct a clinical trial at a prospective trial site; • we may experience difficulty in designing clinical trials and in selecting endpoints for diseases that have not been well-studied and for which the natural history and course of the disease is poorly understood; • preclinical and clinical testing may generate imprecise data and the results can be interpreted in different ways; • the selection of certain clinical endpoints may require prolonged periods of clinical observation or analysis of the resulting data; • we may experience difficulties in successfully enrolling subjects in the clinical trials, for example, the number of patients required for clinical trials of our product candidates may be larger than we anticipate, enrollment in these clinical trials may be slower than we anticipate or participants may drop out of these clinical trials at a higher rate than we anticipate; • regulators or institutional review boards may require that we or our investigators suspend or terminate clinical trials for various reasons, including non-compliance with regulatory requirements; • regulators may not accept data from our clinical trials completed in foreign jurisdictions if we do not satisfy certain regulatory requirements; • clinical trials of our product candidates may produce negative or inconclusive results, and we may decide, or regulators may require us, to expand current clinical studies, or to conduct additional clinical trials or abandon product development programs; and • the cost of clinical trials of our product candidates may be greater than we anticipate.
We may experience numerous unforeseen events during, or as a result of, clinical trials, that could delay or prevent our ability to receive marketing approval or commercialize our product candidates, including: • we may experience delays in reaching, or may fail to reach, a consensus with regulators on trial design; • the supply or quality of our product candidates or other materials necessary to conduct clinical trials of our product candidates may be insufficient or inadequate, including as a result of delays in the testing, validation, manufacturing and delivery of product candidates to the clinical sites by us or by third parties with whom we have contracted to perform certain of those functions; • we may experience delays in reaching, or may fail to reach, agreement on acceptable clinical trial contracts or clinical trial protocols with prospective trial sites; • regulators or institutional review boards may not authorize us or our investigators to commence a clinical trial or conduct a clinical trial at a prospective trial site; 10 Table of Contents • we may experience difficulty in designing clinical trials and in selecting endpoints for diseases that have not been well-studied and for which the natural history and course of the disease is poorly understood; • preclinical and clinical testing may generate imprecise data and the results can be interpreted in different ways; • the selection of certain clinical endpoints may require prolonged periods of clinical observation or analysis of the resulting data; • we may experience difficulties in successfully enrolling subjects in the clinical trials, for example, the number of patients required for clinical trials of our product candidates may be larger than we anticipate, enrollment in these clinical trials may be slower than we anticipate or participants may drop out of these clinical trials at a higher rate than we anticipate; • regulators or institutional review boards may require that we or our investigators suspend or terminate clinical trials for various reasons, including non-compliance with regulatory requirements; • regulators may not accept data from our clinical trials completed in foreign jurisdictions if we do not satisfy certain regulatory requirements; • clinical trials of our product candidates may produce negative or inconclusive results, or may fail to demonstrate superiority versus the standard of care, and we may decide, or regulators may require us, to expand current clinical studies, or to conduct additional clinical trials or abandon product development programs; and • the cost of clinical trials of our product candidates may be greater than we anticipate.
Investors should consult their own tax advisors regarding the potential application of Section 7874 of the Code to us. 44 Table of Contents If we were characterized as a passive foreign investment company, or “PFIC,” U.S. investors may suffer adverse U.S. federal income tax consequences.
Investors should consult their own tax advisors regarding the potential application of Section 7874 of the Code to us. 42 Table of Contents If we were characterized as a passive foreign investment company, or “PFIC,” U.S. investors may suffer adverse U.S. federal income tax consequences.
Competitors may use our technologies in 36 Table of Contents jurisdictions where we have not obtained patent protection to develop their own drugs and further, may export otherwise infringing drugs to non-United States jurisdictions where we have patent protection, but where enforcement rights are not as strong as those in the United States.
Competitors may use our technologies in 34 Table of Contents jurisdictions where we have not obtained patent protection to develop their own drugs and further, may export otherwise infringing drugs to non-United States jurisdictions where we have patent protection, but where enforcement rights are not as strong as those in the United States.
For instance, we are not required to: • have a majority of the board be independent (although all of the members of the audit committee must be independent under the Exchange Act); 47 Table of Contents • have a compensation committee or a nominations or corporate governance committee consisting entirely of independent directors; • have regularly scheduled executive sessions with only independent directors each year; • have an annual meeting of shareholders or solicit proxies or provide proxy statements for all meetings of shareholders; or • obtain shareholder approval for any issuances of our securities.
For instance, we are not required to: • have a majority of the board be independent (although all of the members of the audit committee must be independent under the Exchange Act); • have a compensation committee or a nominations or corporate governance committee consisting entirely of independent directors; • have regularly scheduled executive sessions with only independent directors each year; • have an annual meeting of shareholders or solicit proxies or provide proxy statements for all meetings of shareholders; or • obtain shareholder approval for any issuances of our securities.
If we later sue such third party for patent infringement, the third party may have certain legal defenses available to it, which otherwise would not be available except for the delay between when 38 Table of Contents the infringement was first detected and when the suit was brought.
If we later sue such third party for patent infringement, the third party may have certain legal defenses available to it, which otherwise would not be available except for the delay between when 36 Table of Contents the infringement was first detected and when the suit was brought.
If the results of our ongoing or future preclinical studies and clinical trials are inconclusive or inconsistent with respect to the safety, bioavailability, potency and efficacy of our product candidates, if we do not meet the clinical endpoints with statistical and clinically meaningful significance, if the drugs manufactured for clinical testing or for commercialization do not meet the approval requirements of the development program of our product candidates, or if there are safety, potency or efficacy concerns associated with our product candidates, we may be prevented from or delayed in obtaining marketing approval for such product candidates.
If the results of our ongoing or future preclinical studies and clinical trials are inconclusive or inconsistent with respect to the safety, bioavailability, potency and efficacy of our product candidates, if we do not meet the clinical endpoints with statistical and clinically meaningful significance, if the drugs manufactured for clinical testing or for commercialization do not meet the approval requirements of the development program of our product candidates, or if there are safety, potency or efficacy concerns associated with our product candidates, we may be prevented from or delayed in obtaining marketing 11 Table of Contents approval for such product candidates.
The failure to implement and maintain effective internal control over financial reporting could result in material misstatements in our financial statements in the future, which could require us to restate financial statements, cause investors to lose confidence in the reported financial information and have a negative effect on the price of our Class A Ordinary Shares. • As an exempted company incorporated in the Cayman Islands, we are permitted to adopt certain home country practices in relation to corporate governance matters that differ significantly from the Nasdaq listing standards; these practices may afford less protection to shareholders than they would enjoy if we comply fully with the Nasdaq listing standards. • We qualify as an “emerging growth company” and a foreign private issuer within the meaning of the Securities Act, and if we take advantage of certain exemptions from disclosure requirements available to emerging growth companies and foreign private issuers, it could make our securities less attractive to investors and may make it more difficult to compare our performance to the performance of other public companies. • There is no guarantee that the Warrants will be in the money and they may expire worthless. 5 Table of Contents RISK FACTORS In addition to the other information contained in this Annual Report, including the matters addressed under the heading “Forward-Looking Statements,” you should carefully consider the following risk factors before making an investment decision.
The failure to implement and maintain effective internal control over financial reporting could result in material misstatements in our financial statements in the future, which could require us to restate financial statements, cause investors to lose confidence in the reported financial information and have a negative effect on the price of our Class A Ordinary Shares. • As an exempted company incorporated in the Cayman Islands, we are permitted to adopt certain home country practices in relation to corporate governance matters that differ significantly from the Nasdaq listing standards; these practices may afford less protection to shareholders than they would enjoy if we comply fully with the Nasdaq listing standards. • We qualify as an “emerging growth company” and a foreign private issuer within the meaning of the Securities Act, and we take advantage of certain exemptions from disclosure requirements available to emerging growth companies and foreign private issuers, that could make our securities less attractive to investors and may make it more difficult to compare our performance to the performance of other public companies. • There is no guarantee that the Warrants will ever be in the money and they may expire worthless. 6 Table of Contents RISK FACTORS In addition to the other information contained in this Annual Report, including the matters addressed under the heading “Cautionary Statement Regarding Forward-Looking Statements,” you should carefully consider the following risk factors before making an investment decision.
Internal Revenue Code of 1986, as amended (the “ Code ”) provides an exception to this general rule, under which a non-U.S. incorporated entity may, in certain circumstances, be treated as a U.S. corporation for U.S. federal income tax purposes.
Internal Revenue Code of 1986, as amended (the “Code”) provides an exception to this general rule, under which a non-U.S. incorporated entity may, in certain circumstances, be treated as a U.S. corporation for U.S. federal income tax purposes.
For example, our product candidates face competition in the United States, China and Europe from a significant number of advanced drug products (either marketed or under development) involving molecular targets (such as immune checkpoint inhibitors), disease indications (such as cancer) and mechanism of actions (such as bi-specific antibodies, combination therapies, etc.) that are similar or identical to those of our product candidates.
For example, our product candidates face competition in the United States, China and Europe from a significant number of advanced drug products (either marketed or under development) involving molecular targets (such as immune checkpoint 16 Table of Contents inhibitors), disease indications (such as cancer) and mechanism of actions (such as bi-specific antibodies, combination therapies, etc.) that are similar or identical to those of our product candidates.
For example, on January 16, 2024, we received a notification (the “Nasdaq Notice”) from Nasdaq stating that the Company is not in compliance with the requirement to maintain a minimum closing bid price of $1.00 per share, as set forth in Nasdaq Listing Rule 5550(a)(2) (the “Bid Price Requirement”), because the closing bid price of the our Class A Ordinary Shares was below $1.00 per share for 30 consecutive business days.
For example, on January 16, 2024, we received a notification from Nasdaq stating that the Company was not in compliance with the requirement to maintain a minimum closing bid price of $1.00 per share, as set forth in Nasdaq Listing Rule 5550(a)(2) (the “Bid Price Requirement”), because the closing bid price of the our Class A Ordinary Shares was below $1.00 per share for 30 consecutive business days.
Federal Income Tax • The IRS may not agree that we should be treated as a non-U.S. corporation for U.S. federal income tax purposes. • If we were characterized as a passive foreign investment company, or “ PFIC ,” U.S. investors may suffer adverse U.S. federal income tax consequences.
Federal Income Tax • The IRS may not agree that we should be treated as a non-U.S. corporation for U.S. federal income tax purposes. • If we were characterized as a passive foreign investment company, or “PFIC,” U.S. investors may suffer adverse U.S. federal income tax consequences.
As of the date of this Annual Report, we were not aware that there was any generic versions of our product candidates marketed or under clinical trials. However, we cannot assure you that there will not be any such generic alternatives in future.
As of the date of this Annual Report, we were not aware of any generic versions of our product candidates being marketed or under clinical trials. However, we cannot assure you that there will not be any such generic alternatives in future.
Notably, the exercise price of the Penny Warrants ($0.01 per share) is significantly lower than the current trading price of our Class A Ordinary Shares (as discussed below), whereas the exercise price of the Public Warrants and Private Warrants (each at $11.50 per share) is higher than the current trading price of our Class A Ordinary Shares.
Notably, the exercise price of the Penny Warrants ($0.01 per 0.01 share) is significantly lower than the current trading price of our Class A Ordinary Shares (as discussed below), whereas the exercise price of the Public Warrants and Private Warrants (each at $11.50 per 0.01 share) is significantly higher on a per-share basis than the current trading price of our Class A Ordinary Shares.
If we are unable to reach agreements with suitable 26 Table of Contents collaboration partners on a timely basis, on acceptable terms, or at all, we may have to curtail the development of a product candidate, reduce or delay its development program or one or more of our other development programs, delay its potential commercialization or reduce the scope of any sales or marketing activities, or increase our expenditures and undertake development or commercialization activities at our own expense.
If we are unable to reach agreements with suitable collaboration partners on a timely basis, on acceptable terms, or at all, we may have to curtail the development of a product candidate, reduce or delay its development program or one or more of our other development programs, delay its potential commercialization or reduce the scope of any sales or marketing activities, or increase our expenditures and undertake development or commercialization activities at our own expense.
If we do not address these risks and difficulties successfully, this could materially adversely affect our business, financial condition, results of operations and prospects. We have no track record in launching and marketing any commercial products.
If we do not address these risks and difficulties successfully, they could materially adversely affect our business, financial condition, results of operations and prospects. We have no track record in launching and marketing any commercial products.
For example, if our collaborator(s) did not provide CMC, preclinical, or clinical data to us on a timely basis or if such data were inadequate for meeting regulatory purposes, the application for marketing approval of our product candidates could be delayed, denied, withheld, or withdrawn from health authorities like the FDA, NMPA, or other comparable health authorities.
For example, if our collaborator(s) did not provide CMC, preclinical, or clinical data to us on a timely basis or if such data were inadequate for meeting 22 Table of Contents regulatory purposes, the application for marketing approval of our product candidates could be delayed, denied, withheld, or withdrawn from health authorities like the FDA, NMPA, or other comparable health authorities.
In such circumstances, the trading price of our securities may not recover and may experience a further decline. 45 Table of Contents Factors affecting the trading price of our securities may include: • actual or anticipated fluctuations in our quarterly financial results or the quarterly financial results of companies perceived to be similar to us; • changes in the market’s expectations about our operating results; • success of competitors; • our operating results failing to meet the expectation of securities analysts or investors in a particular period; • changes in financial estimates and recommendations by securities analysts concerning us or the industry in which we operate; • operating and share price performance of other companies that investors deem comparable to us; • our ability to market new and enhanced products and technologies on a timely basis; • changes in laws and regulations affecting our business; • our ability to meet compliance requirements; • commencement of, or involvement in, litigation involving us; • changes in our capital structure, such as future issuances of securities or the incurrence of additional debt; • the volume of our Class A Ordinary Shares available for public sale; • any major change in our Board or management; • sales of substantial amounts of our Class A Ordinary Shares by our directors, executive officers or significant stockholders or the perception that such sales could occur; and • general economic and political conditions such as recessions, interest rates, international currency fluctuations and acts of war or terrorism.
Factors affecting the trading price of our securities may include: • actual or anticipated fluctuations in our quarterly financial results or the quarterly financial results of companies perceived to be similar to us; • changes in the market’s expectations about our operating results; • success of competitors; • our operating results failing to meet the expectation of securities analysts or investors in a particular period; • changes in financial estimates and recommendations by securities analysts concerning us or the industry in which we operate; • operating and share price performance of other companies that investors deem comparable to us; 43 Table of Contents • our ability to market new and enhanced products and technologies on a timely basis; • changes in laws and regulations affecting our business; • our ability to meet compliance requirements; • commencement of, or involvement in, litigation involving us; • changes in our capital structure, such as future issuances of securities or the incurrence of additional debt; • the volume of our Class A Ordinary Shares available for public sale; • any major change in our Board or management; • sales of substantial amounts of our Class A Ordinary Shares by our directors, executive officers or significant stockholders or the perception that such sales could occur; and • general economic and political conditions such as recessions, interest rates, international currency fluctuations and acts of war or terrorism.
Although we have adopted various measures to ensure our employees would adhere to our internal control measures to maintain confidentiality of our information, these measures may not be always effective, for example, our information technology systems could be breached through hacking activities, and personal information could be leaked due to theft or misuse of personal information arising from misconduct or negligence.
Although we 29 Table of Contents have adopted various measures to ensure our employees would adhere to our internal control measures to maintain confidentiality of our information, these measures may not be always effective, for example, our information technology systems could be breached through hacking activities, and personal information could be leaked due to theft or misuse of personal information arising from misconduct or negligence.
Although our ability to amend the terms of the Public Warrants and Private 50 Table of Contents Warrants with the consent of a majority of the then outstanding Public Warrants is unlimited, examples of such amendments could be amendments to, among other things, increase the exercise price of the warrants, convert the warrants into stock or cash, shorten the exercise period or decrease the number of warrant shares issuable upon exercise of a warrant.
Although our ability to amend the terms of the Public Warrants and Private Warrants with the consent of a majority of the then outstanding Public Warrants is unlimited, examples of such amendments could be amendments to, among other things, increase the exercise price of the warrants, convert the warrants into stock or cash, shorten the exercise period or decrease the number of warrant shares issuable upon exercise of a warrant.
The agreement provides that the terms of the Public Warrants and Private Warrants may be amended without the consent of any holder to cure any ambiguity or correct any defective provision but requires the approval by the holders of at least a majority of the then outstanding Public Warrants to make any change that adversely affects the interests of the registered holders.
The agreement provides that the terms of the Public Warrants and Private Warrants may be amended without the consent of 47 Table of Contents any holder to cure any ambiguity or correct any defective provision but requires the approval by the holders of at least a majority of the then outstanding Public Warrants to make any change that adversely affects the interests of the registered holders.
There may be prior art of which we are not aware that may affect the patentability of our patent claims or, if issued, affect the 42 Table of Contents validity or enforceability of a patent claim.
There may be prior art of which we are not aware that may affect the patentability of our patent claims or, if issued, affect the 40 Table of Contents validity or enforceability of a patent claim.
Our operations to date have focused on business planning, raising capital, establishing our intellectual property portfolio, drug discovery and conducting preclinical studies and clinical trials of our 6 Table of Contents product candidates. We do not have any developed products approved for commercial sale and have not generated any revenue from developed product sales.
Our operations to date have focused on business planning, raising capital, establishing our intellectual property portfolio, drug discovery and conducting preclinical studies and clinical trials of our product candidates. We do not have any developed products approved for commercial sale and have not generated any revenue from developed product sales.
Additionally, neither we nor any of our PRC Subsidiaries has been required by any PRC governmental authority to apply for cybersecurity review, nor have we or any of our PRC Subsidiaries received any inquiry, notice, warning, sanction in such respect or been denied permission from any PRC regulatory authority to list on U.S. exchanges.
Additionally, neither we nor any of our PRC Subsidiaries has been required by any PRC governmental authority to 31 Table of Contents apply for cybersecurity review, nor have we or any of our PRC Subsidiaries received any inquiry, notice, warning, sanction in such respect or been denied permission from any PRC regulatory authority to list on U.S. exchanges.
In response, certain governments, including China, have imposed tariffs on the import of certain U.S. goods. Although innovative drugs have not been the subject of the United States or Chinese tariffs, it remains unclear what the United States, China or other governments will or will not do with respect to tariffs or other international trade policies.
In response, certain governments, including China, have imposed tariffs on the import of certain U.S. goods. Although innovative drugs have not been the subject of the United States or Chinese tariffs, it remains unclear what the United States, China or other governments will or will not 32 Table of Contents do with respect to tariffs or other international trade policies.
If we become a PFIC for any taxable year (or portion thereof) that is included in the holding period of a U.S. Holder (as defined in the section of this Annual Report captioned “ Taxation—Certain U.S. Federal Income Tax Considerations ”) of our securities, the U.S.
If we become a PFIC for any taxable year (or portion thereof) that is included in the holding period of a U.S. Holder (as defined in the section of this Annual Report captioned Item 10.E. “ Taxation—Certain U.S. Federal Income Tax Considerations ”) of our securities, the U.S.
We, our CROs and our development partners for our preclinical and clinical programs and our clinical investigators are required to comply with the good laboratory practice (“GLP”) and good clinical practice (“GCP”), which are regulations and guidelines enforced by the FDA, NMPA and other comparable regulatory authorities for all 24 Table of Contents of our drugs in preclinical and clinical development.
We, our CROs and our development partners for our preclinical and clinical programs and our clinical investigators are required to comply with the good laboratory practice (“GLP”) and good clinical practice (“GCP”), which are regulations and guidelines enforced by the FDA, NMPA and other comparable regulatory authorities for all of our drugs in preclinical and clinical development.
If we decide to pursue accelerated approval for any of our product candidates, it may not lead to a faster development or regulatory review or approval process and does not increase the likelihood that our product candidates will receive marketing approval. We are considering pursuing accelerated approval for one or more of our product candidates.
If we decide to pursue accelerated approval for any of our product candidates, it may not lead to a faster development or regulatory review or approval process and does not increase the likelihood that our product candidates will receive marketing approval. We may consider pursuing accelerated approval for one or more of our product candidates.
Switching or adding additional CROs involves additional cost and delays (including identifying and training suitable additional/replacement clinical investigators and obtaining required IRB approval for any additional/new clinical trial site), which can materially influence our ability to meet our desired clinical development timelines.
Switching or adding additional CROs may involve additional cost and delays (including identifying and training suitable additional/replacement clinical investigators and obtaining required IRB approval for any additional/new clinical trial site), which can materially influence our ability to meet our desired clinical development timelines.
For example, recently, the FDA declined to approve sintilimab for non-small cell lung cancer (“NSCLC”), in part, because pivotal data were exclusively collected in China.
For example, in 2022, the FDA declined to approve sintilimab for non-small cell lung cancer (“NSCLC”), in part, because pivotal data were exclusively collected in China.
If we are unable to obtain regulatory approval for our product candidates in one or more jurisdictions, or any approval contains significant limitations, our target market will be reduced and our ability to realize the full market 13 Table of Contents potential of our product candidates will be harmed.
If we are unable to obtain regulatory approval for our product candidates in one or more jurisdictions, or any approval contains significant limitations, our target market will be reduced and our ability to realize the full market potential of our product candidates will be harmed.

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Item 4. Mine Safety Disclosures

Mine Safety Disclosures — required of mining issuers

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Biggest changeDrug Candidate Scope / Type of Patent Protection Jurisdiction Status Applicant Uproleselan E-Selectin antagonist compounds, compositions, and methods of use / Composition of Matter and Method of Use China, Hong Kong Granted GlycoMimetics Uproleselan Compounds, compositions and methods using E-Selectin antagonists for mobilization of hematopoietic cells / Composition of Matter and Method of Use China Granted GlycoMimetics Uproleselan Methods for treating acute myeloid leukemia and related conditions / Methods of Use China Pending GlycoMimetics Uproleselan Combination T-cell check point inhibitor and E-Selectin inhibitor / Combination for use in a method Hong Kong Granted GlycoMimetics APL-108 Efficient polymer E-Selectin antagonist / Composition of Matter and Method of Use China Granted GlycoMimetics APL-108 Efficient polymer E-Selectin antagonist / Composition of Matter and Method of Use China, Hong Kong Pending GlycoMimetics APL-122 Alkyne Substituted Quinazoline Compound as ErbB inhibitor / Composition of Matter and Method of Use Australia, Brazil, Canada, France, Germany, United Kingdom, Switzerland, Israel, Korea, India, Japan, Mexico, U.S.
Biggest changeDrug Candidate Scope / Type of Patent Protection Jurisdiction Status Applicant APL-122 Alkyne Substituted Quinazoline Compound as ErbB inhibitor / Composition of Matter and Method of Use Australia, Brazil, Canada, France, Germany, United Kingdom, Switzerland, Israel, Korea, India, Japan, Mexico, U.S. Granted Newgen Therapeutics Inc.
By leveraging our global network, we have access to subjects from different continents to achieve enrollment goals for our clinical trials and regulatory objectives in multiple regions. Our Key Competitive Strengths We believe the following capabilities and competitive strengths will enable us to achieve our business strategy: • Science-driven approach powering a pipeline of next-generation therapies for patients globally.
By leveraging our global network, we have access to subjects from different continents to achieve the enrollment goals for our clinical trials and regulatory objectives in multiple regions. Our Key Competitive Strengths We believe the following capabilities and competitive strengths will enable us to achieve our business strategy: • Science-driven approach powering a pipeline of next-generation therapies for patients globally.
The FDA recommended that we propose an additional meeting to discuss our development plan and data package required to support a marketing application for vebreltinib for “traditional approval.” We sought feedback from the FDA in a Type C meeting held February 2024.
The FDA recommended that we propose an additional meeting to discuss our development plan and data package required to support a marketing application for vebreltinib for “traditional approval.” We sought feedback from the FDA in a Type C meeting held in February 2024.
The following table summarizes the details of the granted patents and the filed patent applications owned by us on vebreltinib, APL-501, APL-502 and APL-102.
The following table summarizes the details of the granted patents and the filed patent applications owned by us on vebreltinib, APL-102, APL-501 and APL-502.
Fast Track Designation and Priority Review Through the fast track designation, FDA is required to facilitate the development, and expedite the review, of drugs or biological products that are intended for the treatment of a serious or life-threatening disease or condition and demonstrates the potential to address unmet medical needs for the condition.
Fast Track Designation and Priority Review Through the fast track designation, the FDA is required to facilitate the development, and expedite the review, of drugs or biological products that are intended for the treatment of a serious or life-threatening disease or condition and demonstrates the potential to address unmet medical needs for the condition.
Fast track designation applies to both the product and the specific indication for which it is being studied. Any product submitted to FDA for marketing, including under a fast track program, may be eligible for other types of FDA programs intended to expedite development and review, such as priority review.
Fast track designation applies to both the product and the specific indication for which it is being studied. Any product submitted to the FDA for marketing, including under a fast track program, may be eligible for other types of FDA programs intended to expedite development and review, such as priority review.
Unless otherwise required by regulation, PREA does not apply to any drug or biological product with orphan drug designation except a product with a new active ingredient that is a molecularly targeted cancer product intended for the treatment of an adult cancer and directed at a molecular target determined by FDA to be substantially relevant to the growth or progression of a pediatric cancer.
Unless otherwise required by regulation, PREA does not apply to any drug or biological product with orphan drug designation except a product with a new active ingredient that is a molecularly targeted cancer product intended for the treatment of an adult cancer and directed at a molecular target determined by the FDA to be substantially relevant to the growth or progression of a pediatric cancer.
Conditions for exclusivity include the FDA’s determination that information relating to the use of a new drug or biological product in the pediatric population may produce health benefits in that population, FDA making a written request for pediatric studies, and the applicant agreeing to perform, and reporting on, the requested studies within the statutory timeframe.
Conditions for exclusivity include the FDA’s determination that information relating to the use of a new drug or biological product in the pediatric population may produce health benefits in that population, the FDA making a written request for pediatric studies, and the applicant agreeing to perform, and reporting on, the requested studies within the statutory timeframe.
The Hatch-Waxman Amendments Orange Book Listing Under the Drug Price Competition and Patent Term Restoration Act of 1984, commonly referred to as the Hatch Waxman Amendments, NDA applicants are required to identify to FDA each patent whose claims cover the applicant’s drug or approved method of using the drug.
The Hatch-Waxman Amendments Orange Book Listing Under the Drug Price Competition and Patent Term Restoration Act of 1984, commonly referred to as the Hatch Waxman Amendments, NDA applicants are required to identify to the FDA each patent whose claims cover the applicant’s drug or approved method of using the drug.
Certain changes to an approved drug, such as the approval of a new indication, the approval of a new strength, and the approval of a new condition of use, are associated with a three-year period of exclusivity from the date of approval during which FDA cannot approve an ANDA for a generic drug that includes the change.
Certain changes to an approved drug, such as the approval of a new indication, the approval of a new strength, and the approval of a new condition of use, are associated with a three-year period of exclusivity from the date of approval during which the FDA cannot approve an ANDA for a generic drug that includes the change.
In some instances, an ANDA applicant may receive approval prior to expiration of the three-year exclusivity if the applicant seeks, and FDA permits, the omission of such exclusivity-protected information from the ANDA package insert. Patent Term Extension The Hatch Waxman Amendments permit a patent term extension as compensation for patent term lost during the FDA regulatory review process.
In some instances, an ANDA applicant may receive approval prior to expiration of the three-year exclusivity if the applicant seeks, and the FDA permits, the omission of such exclusivity-protected information from the ANDA package insert. Patent Term Extension The Hatch Waxman Amendments permit a patent term extension as compensation for patent term lost during the FDA regulatory review process.
The time can be reduced for any time FDA determines that the applicant did not pursue approval with due diligence. The USPTO, in consultation with the FDA, reviews and approves the application for any patent term extension or restoration.
The time can be reduced for any time the FDA determines that the applicant did not pursue approval with due diligence. The USPTO, in consultation with the FDA, reviews and approves the application for any patent term extension or restoration.
If FDA determines that a companion diagnostic device is essential to the safe and effective use of a new therapeutic product or indication, FDA generally will not approve the therapeutic product or new therapeutic product indication if the companion diagnostic device is not approved, authorized or cleared for that indication.
If FDA determines that a companion diagnostic device is essential to the safe and effective use of a new therapeutic product or indication, the FDA generally will not approve the therapeutic product or new therapeutic product indication if the companion diagnostic device is not approved, authorized or cleared for that indication.
We are not presently a party to any litigation or legal proceedings that we believe could have a material adverse effect on our business or financial condition. Regardless of outcome, litigation can have an adverse impact on us because of defense and settlement costs, diversion of management resources, and other factors. C.
We are not presently a party to any other litigation or legal proceedings that we believe could have a material adverse effect on our business or financial condition. Regardless of outcome, litigation can have an adverse impact on us because of defense and settlement costs, diversion of management resources, and other factors. C.
License Agreement with Edison Related to APL-122 On January 31, 2021, we entered into a license agreement with Edison under which Edison granted us an exclusive, royalty-bearing, non-transferable, sublicensable (subject to certain conditions specified therein) license under certain intellectual property controlled by Edison or its affiliates to develop, manufacture, use, sell, import, export and commercialize APL-122 (the “Edison Licensed Drug Substance”) and any pharmaceutical products containing the same (the “Edison Licensed Products”), (the “Edison Agreement”), for all uses in humans (the “Edison Licensed Field”) outside China, Hong Kong and Taiwan (the “Edison Licensed Territory”).
Edison On January 31, 2021, we entered into a license agreement with Edison under which Edison granted us an exclusive, royalty-bearing, non-transferable, sublicensable (subject to certain conditions specified therein) license under certain intellectual property controlled by Edison or its affiliates to develop, manufacture, use, sell, import, export and commercialize APL-122 (the “Edison Licensed Drug Substance”) and any pharmaceutical products containing the same (the “Edison Licensed Products”), (the “Edison Agreement”), for all uses in humans (the “Edison Licensed Field”) outside China, Hong Kong and Taiwan (the “Edison Licensed Territory”).
Steady-State Drug Concentration of Vebreltinib in Phase I Study in NSCLC subjects (HMO-PLB1001-2013012-01) Avistone (China) Phase 1 Glioblastoma Multiforme Trial- Study HMO-PLB1001-I-GBM-01 Study HMO-PLB1001-I-GBM-01 (sponsored by Pearl) was a Phase 1, open-label dose-escalation and expansion study of vebreltinib to assess safety and tolerability, and to determine the RP2D of vebreltinib in subjects with PTPRZ1-MET fusion-gene (ZM fusion) positive recurrent high-grade gliomas.
Steady-State Drug Concentration of Vebreltinib in Phase I Study in NSCLC subjects (HMO-PLB1001-2013012-01) Avistone (China) Phase 1 Glioblastoma Multiforme Trial- Study HMO-PLB1001-I-GBM-01 Study HMO-PLB1001-I-GBM-01 (sponsored by Avistone) was a Phase 1, open-label dose-escalation and expansion study of vebreltinib to assess safety and tolerability, and to determine the RP2D of vebreltinib in subjects with PTPRZ1-MET fusion-gene (ZM fusion) positive recurrent high-grade gliomas.
Additional secondary endpoints include ORR per investigator assessment based on RECIST v1.1, antitumor activity by clinical benefit rate (CR + PR + SD ≥ 4 cycles) based on RECIST v1.1 (or relevant criteria per tumor type), median time to progression (“TTP”), and progression free survival (“PFS”) and overall survival (“OS”) at 6, 12, 18 and 24 months.
Additional secondary endpoints include ORR per investigator assessment based on RECIST v1.1, antitumor activity by clinical benefit rate (CR + PR + SD ≥ 4 cycles) based on RECIST v1.1 (or relevant criteria per tumor type), median time to progression, and progression free survival (“PFS”) and overall survival (“OS”) at 6, 12, 18 and 24 months.
However, the development of our product candidates by such third parties has the potential to benefit the regulatory status and development costs of such product candidates in the geographies and trials for which we are responsible have control, due to our ability to access the developmental and clinical data from such third parties and to benefit from the feedback of such trials as information regarding such trials is made available.
However, the development of our product candidates by such third parties has the potential to benefit the regulatory status and development costs of such product candidates in the geographies and trials for which we are responsible and have control over, due to our ability to access the developmental and clinical data from such third parties and to benefit from the feedback of such trials as information regarding such trials is made available.
FDA recommended we continue enrollment in this SPARTA cohort to increase the precision around the point estimate for ORR and provide geographic diversity for the purpose of accelerated approval NDA package to potentially support a marketing authorization based on the single arm trial results from KUNPENG and SPARTA for this indication.
The FDA recommended we continue enrollment in this SPARTA cohort to increase the precision around the point estimate for ORR and provide geographic diversity for the purpose of an accelerated approval NDA package to potentially support a marketing authorization based on the single arm trial results from KUNPENG and SPARTA for this indication.
The extracellular portion of c-Met is composed of three domain types: (i) a ligand binding domain, semaphorin (“Sema”) domain; (ii) a plexin-semaphorin-integrin (“PSI”) domain which follows the Sema domain; and (iii) four immunoglobulin-plexin-transcription (“IPT”) domains, which connect the PSI domain to the transmembrane helix.
The extracellular portion of c-Met is composed of three domain types: (i) a ligand binding domain, the semaphorin (“Sema”) domain; (ii) a plexin-semaphorin-integrin (“PSI”) domain which follows the Sema domain; and (iii) four immunoglobulin-plexin-transcription domains, which connect the PSI domain to the transmembrane helix.
In relation to the Structure Patents, the General Method Patent and the Withdrawn Method Patent Application, we believe the following: • Despite the existence of the Structure Patents, the General Method Patent and the Withdrawn Method Patent Application, we have not infringed the intellectual property rights of any third parties that may give rise to a claim of infringement of intellectual property rights by any third party for injunctive relief or actual damages because the jurisdictions where we are conducting clinical trials exempt clinical trials and other activities for obtaining regulatory approvals from patent infringements. • The underlying claims in relation to the Potential Contentions, if pursued, might not prevail if the validity or valid scope of the relevant patents is not acknowledged by the relevant court or administrative agency. • With respect to any issued patent in the United States or European Union, the term of which is extended to compensate for the patent term lost during the clinical trials and regulatory review, the rights derived from such patent during the extended period are only limited to the structure of an approved drug, its salts or other forms, and its approved indications.
In relation to the Structure Patents, the General Method Patent and the Withdrawn Method Patent Application, we believe the following: • Despite the existence of the Structure Patents, the General Method Patent and the Withdrawn Method Patent Application, we have not infringed the intellectual property rights of any third parties that may give rise to a claim of infringement of intellectual property rights by any third party for injunctive relief or actual damages because the jurisdictions where we are conducting clinical trials exempt clinical trials and other activities for obtaining regulatory approvals from patent infringements. • The underlying claims in relation to the Potential Contentions, if pursued, might not prevail if the validity or valid scope of the relevant patents is not acknowledged by the relevant court or administrative agency. 75 Table of Contents • With respect to any issued patent in the United States or European Union, the term of which is extended to compensate for the patent term lost during the clinical trials and regulatory review, the rights derived from such patent during the extended period are only limited to the structure of an approved drug, its salts or other forms, and its approved indications.
For NSCLC with Met Exon 14 skipping, FDA suggested primary efficacy analyses be conducted on patients with central NGS confirmation, even though SPARTA study enrollment was based on local NGS results and retrospective central confirmation was conducted whenever possible.
For NSCLC with Met Exon 14 skipping, the FDA suggested primary efficacy analyses be conducted on patients with central NGS confirmation, even though SPARTA study enrollment was based on local NGS results and retrospective central confirmation was conducted whenever possible.
NSCLC patients with MetExon14 skipping mutation without co-occurring MET amplification (gene copy number or GCN This presentation may represent the first publicly available analysis on a c-Met inhibitor in treatment of NSCLC with MET exon14 skipping mutation, in which the GCN distribution in the study population resembles the real world (large public database) and the treatment can achieve sufficient efficacy (with ORR of 64.5%) in those without overlapping c-Met amplification, a subgroup representing over 83% of NSCLC with Met Exon 14 skipping, an important patient population previously reported in other c-Met inhibitor pivotal trials that supported US or China approvals with substantially lower ORR.
NSCLC patients with MetExon14 skipping mutation without co-occurring MET amplification (gene copy number or GCN This presentation may represent the first publicly available analysis on a c-Met inhibitor in treatment of NSCLC with MET exon14 skipping mutation, in which the GCN distribution in the study population resembles the real world (large public database) and the treatment can achieve sufficient efficacy (with ORR of 64.5%) in those without overlapping c-Met amplification, a subgroup representing over 83% of NSCLC with Met Exon 14 skipping, an important patient population previously reported in other c-Met inhibitor pivotal trials that supported U.S. or China approvals with substantially lower ORR.
In China, another two c-Met inhibitors, savolitinib and gumarontinib, in addition to vebreltinib (being developed and commercialized by our partner Avistone in China), are also approved for treatment of NSCLC with Met Exon 14 skipping, under conditional approval. Vebreltinib is a selective and potent inhibitor of the c-Met receptor kinase, which is overexpressed and/or mutated in several tumor types.
In China, two other c-Met inhibitors, savolitinib and gumarontinib, in addition to vebreltinib (being developed and commercialized by our partner Avistone in China), are also approved for treatment of NSCLC with Met Exon 14 skipping, under conditional approval. Vebreltinib is a selective and potent inhibitor of the c-Met receptor kinase, which is overexpressed and/or mutated in several tumor types.
In addition to the primary tumors with c-Met alterations that is associated with treatment resistance and worse treatment outcomes than those without c-Met alterations, c-Met amplification may also develop as part of treatment resistance following targeted TKI treatments against EGFR, ALK, and ROS. c-Met signaling pathway Source: Company Note: (1) c-Met activation induces biological responses via activation of various intracellular signaling pathways.
In addition to the primary tumors with c-Met alterations that is associated with treatment resistance and worse treatment outcomes than those without c-Met alterations, c-Met amplification may also develop as part of treatment resistance following targeted TKI treatments against EGFR, ALK, and ROS. c-Met signaling pathway Source: Company Activation of c-Met induces biological responses via activation of various intracellular signaling pathways.
Efficacy and safety data from the Met Exon 14 skipping NSCLC cohort from KUNPENG Study were presented at the European Society of Medical Oncology Congress (“ESMO”) 2023.
Efficacy and safety data from the Met Exon 14 skipping NSCLC cohort from KUNPENG Study were presented at the European Society of Medical Oncology Congress 2023.
An updated efficacy analysis by GCN subgroup, based on data as of October 26, 2023, with larger number of patients with available GCN information included (N=91) than previously reported in NACLC 2023 presentation continue to show similar trend of vebreltinib being efficacious in the treatment of Met Exon 14 skipping in the absence of overlapping c-Met amplification (GCN In the February 2024 meeting with the FDA, we discussed the number of treatment naïve patients with Met Exon 14 skipping confirmed by central NGS testing that would be required to be treated with vebreltinib for an NDA package in this patient population.
An updated efficacy analysis by GCN subgroup, based on data as of October 26, 2023, with larger number of patients with available GCN information included (N=91) than previously reported in NACLC 2023 presentation continued to show a similar trend of vebreltinib being efficacious in the treatment of Met Exon 14 skipping in the absence of overlapping c-Met amplification (GCN In the February 2024 meeting with the FDA, we discussed the number of treatment naïve patients with Met Exon 14 skipping confirmed by central NGS testing that would be required to be treated with vebreltinib for an NDA package in this patient population.
Pursuant to the Edison Agreement, promptly after the execution date of the Edison Agreement, Edison and we shall use good faith efforts to enter into an agreement between us, Edison, Senz, and our Australian subsidiary, Apollomics (Australia) Pty Ltd., to effectuate the assignment of certain evaluation data generated from use of the Edison Licensed Drug Substance or Edison Licensed Products under a work plan of the Evaluation Agreement from Senz to Apollomics Australia (the “Potential Agreement”).
Pursuant to the Edison Agreement, promptly after the execution date of the Edison Agreement, Edison and we shall use good faith efforts to enter into an agreement between us, Edison, Senz, and our Australian subsidiary, Apollomics (Australia) Pty Ltd., to effectuate the assignment of certain evaluation data generated from use of the Edison Licensed Drug Substance or Edison Licensed Products under a work plan of the Evaluation Agreement from Senz to Apollomics Australia.
To address the needs of cancer patients for safer and more effective cancer treatment solutions, we strive to unlock synergy between treatments and address the issues of drug resistance.
To address the needs of cancer patients for safer and more effective cancer treatment solutions, we strive to unlock the synergy between treatments and address drug resistance.
The abnormal liver enzyme abnormality SAEs and bilirubin elevation SAEs improved to baseline or Grade 1 AE upon study drug discontinuation. 60 Table of Contents Safety summary of Study HMO-PLB1001-2013012-01 The drug exposure increased with the increase in dose during the dose escalation phase in the Phase 1 vebreltinib clinical trial for NSCLC indications.
The abnormal liver enzyme abnormality SAEs and bilirubin elevation SAEs improved to baseline or Grade 1 AE upon study drug discontinuation. 55 Table of Contents Safety summary of Study HMO-PLB1001-2013012-01 The drug exposure increased with the increase in dose during the dose escalation phase in the Phase 1 vebreltinib clinical trial for NSCLC indications.
The concentration in CSF was about 5% of the steady-state plasma. 61 Table of Contents APL-101-01 Phase 1/2 Study in Subjects with solid tumors with c-Met dysregulation — Phase 1 Component (U.S.) – by Apollomics APL-101-01 (SPARTA) is an open-label Phase 1/2 clinical study (conducted by Apollomics), which has two key components.
The concentration in CSF was about 5% of the steady-state plasma. 56 Table of Contents APL-101-01 Phase 1/2 Study in Subjects with solid tumors with c-Met dysregulation — Phase 1 Component (U.S.) – by Apollomics APL-101-01 (SPARTA) is an open-label Phase 1/2 clinical study (conducted by Apollomics), which has two key components.
All of the issued patents are expected to expire in 2033, before taking into account any extension that may be obtained through patent term extension or adjustment, or term reduction due to filing of terminal disclaimers. • APL-102 . We owned two issued U.S. patents, one issued patent in China and six issued patents in other jurisdictions.
All of the issued patents are expected to expire in 2033, before taking into account any extension that may be obtained through patent term extension or adjustment, or term reduction due to filing of terminal disclaimers. • APL-102 . We own two issued U.S. patents, one issued patent in China and six issued patents in other jurisdictions.
Government Regulations Government authorities in the United States, at the federal, state and local level, in China, and in other countries and jurisdictions, extensively regulate, among other things, the research, development, testing, manufacture, quality control, approval, packaging, storage, recordkeeping, labeling, advertising, promotion, distribution, marketing, post-approval monitoring and reporting, and import and export of pharmaceutical products.
Government Regulations Government authorities in the United States, at the federal, state and local level, in Europe, and in other countries and jurisdictions, extensively regulate, among other things, the research, development, testing, manufacture, quality control, approval, packaging, storage, recordkeeping, labeling, advertising, promotion, distribution, marketing, post-approval monitoring and reporting, and import and export of pharmaceutical products.
A retrospective study of 447 57 Table of Contents NSCLC patients with available tumor tissue from primary lung tumor and OS data demonstrated that increase in gene copy number (measuring the extent of amplification) is an independent negative prognostic factor in surgically resected NSCLC with an OS of 25.8 months for subjects with MET > five copies/cell compared with 47.5 months for subjects with MET MET amplification may be occurring as part of the resistance mechanism in NSCLC patients treated with TKIs targeting other mutations such as EGFR, ALK and ROS.
A retrospective study of 447 NSCLC patients with available tumor tissue from primary lung tumor and OS data demonstrated that increase in gene copy number (measuring the extent of amplification) is an independent negative prognostic factor in surgically resected NSCLC with an OS of 25.8 months for subjects with MET > five copies/cell compared with 47.5 months for subjects with MET MET amplification may be occurring as part of the resistance mechanism in NSCLC patients treated with TKIs targeting other mutations such as EGFR, ALK and ROS.
Kinase IC 50 values of APL-102 Kinase APL-102 IC 50 (nM) Flt4(h)(VEGFR-3) 8 Flt1(h)(VEGFR-1) 21 MAP4K5(h) 24 KDR(h)(VEGFR-2) 25 ZAK(h) 26 PDGFRa(V561D)(h) 28 c-RAF(h) 31 DDR1(h) 34 CDKL2(h) 37 cKit(V560G)(h) 38 Fms(h) (CSF1R) 43 APL-102 showed strong inhibition of cell growth on cancer cell lines, including kidney, liver, colorectal, stomach, esophageal, and lung cell lines and syngeneic cell lines, with IC 50 ranging from 0.94 pM to 21.35 pM.
Kinase IC 50 values of APL-102 Kinase APL-102 IC 50 (nM) Flt4(h)(VEGFR-3) 8 Flt1(h)(VEGFR-1) 21 MAP4K5(h) 24 KDR(h)(VEGFR-2) 25 ZAK(h) 26 PDGFRa(V561D)(h) 28 64 Table of Contents c-RAF(h) 31 DDR1(h) 34 CDKL2(h) 37 cKit(V560G)(h) 38 Fms(h) (CSF1R) 43 APL-102 showed strong inhibition of cell growth on cancer cell lines, including kidney, liver, colorectal, stomach, esophageal, and lung cell lines and syngeneic cell lines, with IC 50 ranging from 0.94 pM to 21.35 pM.
Cohort A1 EXON 14 Skipping NSCLC (MET inhibitor naïve) 1L (N up to 80) Cohort A2 EXON 14 Skipping NSCLC (MET inhibitor naïve) 2L/3L (N up to 90) Cohort B EXON 14 Skipping NSCLC (MET inhibitor experienced) - completed (Stage 1=10, Stage 2=19) Cohort C Basket of tumor types except primary CNS tumors, MET amplification (MET inhibitor naïve) (N up to 80) Cohort C-1 NSCLC harboring MET amplification and wild-type EGFR (MET inhibitor naïve) (N up to 46) Cohort C-2 EGFR mutated NSCLC with acquired MET amplification (add APLL-101 to EGFR inhibitor) (N up to 46) 62 Table of Contents Cohort D Basket of tumor types except primary CNS tumors, harboring MET gene fusions (MET inhibitor naïve) (Stage 1=10, Stage 2 up to 36) Cohort E Primary CNS tumors with MET alterations (MET inhibitor naïve) (Stage 1=14, Stage 2 up to 26) Cohort F Basket of tumor types with over expression of HGF & Over-expression of MET; MET WT (Stage 1=10, Stage 2 up to 30) Apollomics is conducting the ongoing Phase 2 portion of the global SPARTA study at approximately 90 study sites in over 10 countries in North America, Europe and Asia-Pacific.
Cohort A1 EXON 14 Skipping NSCLC (MET inhibitor naïve) 1L (N up to 80) Cohort A2 EXON 14 Skipping NSCLC (MET inhibitor naïve) 2L/3L (N up to 90) Cohort B EXON 14 Skipping NSCLC (MET inhibitor experienced) - completed (Stage 1=10, Stage 2=19) Cohort C Basket of tumor types except primary CNS tumors, MET amplification (MET inhibitor naïve) (N up to 80) Cohort C-1 NSCLC harboring MET amplification and wild-type EGFR (MET inhibitor naïve) (N up to 46) Cohort C-2 EGFR mutated NSCLC with acquired MET amplification (add APLL-101 to EGFR inhibitor) (N up to 46) 57 Table of Contents Cohort D Basket of tumor types except primary CNS tumors, harboring MET gene fusions (MET inhibitor naïve) (Stage 1=10, Stage 2 up to 36) Cohort E Primary CNS tumors with MET alterations (MET inhibitor naïve) (Stage 1=14, Stage 2 up to 26) Cohort F Basket of tumor types with over expression of HGF & Over-expression of MET; MET WT (Stage 1=10, Stage 2 up to 30) Apollomics is currently conducting the ongoing Phase 2 portion of the global SPARTA study at approximately 40 study sites in over 10 countries in North America, Europe and Asia-Pacific.
The primary endpoint of the ongoing Phase 2 portion of the SPARTA study is objective response rate (“ORR”) per blinded independent review committee (“BIRC”) by RECIST v.1.1 for NSCLC and other solid tumors and by Response Assessment in Neuro-Oncology (“RANO”) for brain tumors, with median duration of response (“DOR”) as a secondary endpoint.
The primary endpoint of the ongoing Phase 2 portion of the SPARTA study is objective response rate (“ORR”) per blinded independent review committee by RECIST v.1.1 for NSCLC and other solid tumors and by Response Assessment in Neuro-Oncology for brain tumors, with median duration of response (“DOR”) as a secondary endpoint.
Under the Nuance Transfer Agreement, on January 25, 2021 we acquired from Nuance Group all rights and obligations of Nuance under the Underlying TYG License Agreement and certain other related assets, including but not limited to the patent rights to APL-810 controlled by Nuance Group, the related books and records and regulatory materials and approval, and inventories of APL-810 (the “Nuance Closing”).
Under the Nuance Transfer Agreement, on January 25, 2021 we acquired from Nuance Group all rights and obligations of Nuance under the Underlying TYG License Agreement and certain other related assets, including but not limited to the patent rights to APL-810 controlled by Nuance Group, the related books and records and regulatory materials and approval, and inventories of APL-810.
Further, pursuant to the ACA, the Centers for Medicare & Medicaid Services (“CMS”) issued a final rule that requires certain manufacturers of prescription drugs to collect and annually report information on certain payments or transfers of value to physicians (defined to include doctors, dentists, optometrists, podiatrists and chiropractors), physician assistants, certain types of advance practice 97 Table of Contents nurses and teaching hospitals, as well as ownership and investment interests held by physicians and their immediate family members.
Further, pursuant to the ACA, the Centers for Medicare & Medicaid Services (“CMS”) issued a final rule that requires certain manufacturers of prescription drugs to collect and annually report information on certain payments or transfers of value to physicians (defined to include doctors, dentists, optometrists, podiatrists and chiropractors), physician assistants, certain types of advance practice nurses and teaching hospitals, as well as ownership and investment interests held by physicians and their immediate family members.
These studies support the proposed mechanism of action of vebreltinib and its activity in the proposed patient population. 58 Table of Contents MET alterations and oncogenic addiction Source: Company. Vebreltinib Clinical Development We were formerly known as Crown Biotherapeutics (“CBT”), which was a subsidiary of Crown Bioscience International.
These studies support the proposed mechanism of action of vebreltinib and its activity in the proposed patient population. 53 Table of Contents MET alterations and oncogenic addiction Source: Company. Vebreltinib Clinical Development We were formerly known as Crown Biotherapeutics (“CBT”), which was a subsidiary of Crown Bioscience International.
If a compound demonstrates evidence of effectiveness and an acceptable safety profile in Phase 2 evaluations, Phase 3 trials are undertaken to obtain additional information about clinical effects and confirm efficacy and safety in a larger number of patients, typically at geographically dispersed clinical trial sites, to permit the FDA to evaluate the overall benefit-risk relationship of the drug or biologic and 90 Table of Contents to provide adequate information for the labeling of the product.
If a compound demonstrates evidence of effectiveness and an acceptable safety profile in Phase 2 evaluations, Phase 3 trials are undertaken to obtain additional information about clinical effects and confirm efficacy and safety in a larger number of patients, typically at geographically dispersed clinical trial sites, to permit the FDA to evaluate the overall benefit-risk relationship of the drug or biologic and to provide adequate information for the labeling of the product.
Intracellularly, c-Met contains: (i) a juxtamembrane domain that negatively regulates c-Met; (ii) a tyrosine receptor kinase catalytic domain; and (iii) a docking site that recruits several transducers and adaptors when c-Met is active. c-Met is activated by the binding of its ligand, HGF. 56 Table of Contents c-Met, after binding with HGF, activates a variety of intracellular signaling pathways within the cell, including those involved in proliferation, motility, survival, morphogenesis and angiogenesis.
Intracellularly, c-Met contains: (i) a juxtamembrane domain that negatively regulates c-Met; (ii) a tyrosine receptor kinase catalytic domain; and (iii) a docking site that recruits several transducers and adaptors when c-Met is active. c-Met is activated by the binding of its ligand, HGF. c-Met, after binding with HGF, activates a variety of intracellular signaling pathways within the cell, including those involved in proliferation, motility, survival, morphogenesis and angiogenesis.
On July 28, 2016, we (then known as CB Therapeutics, Inc.) entered into a data sublicense agreement with Crown Bioscience (Taicang) (the “Genor Sublicense Agreement”), under which Crown Bioscience (Taicang) granted to us an exclusive sublicense under certain intellectual property rights and materials made by or on behalf of Genor for the research, development and commercialization of APL-501 and the application of patents outside China.
On July 28, 2016, we (then known as CB Therapeutics, Inc.) entered into a data sublicense agreement with Crown Bioscience (Taicang) (the “Genor Sublicense Agreement”), under which Crown Bioscience (Taicang) granted to us an exclusive sublicense under 68 Table of Contents certain intellectual property rights and materials made by or on behalf of Genor for the research, development and commercialization of APL-501 and the application of patents outside China.
The maximum tolerated dose (“MTD”) was not reached (Yang et al. 2020). 59 Table of Contents Efficacy Summary of Study HMO-PLB1001-2013012-01 PR – partial response; SD – stable disease; ORR – objective response rate (complete response (CR) + PR); DCR – disease control rate (CR + PR + SD).
The maximum tolerated dose (“MTD”) was not reached (Yang et al. 2020). 54 Table of Contents Efficacy Summary of Study HMO-PLB1001-2013012-01 PR – partial response; SD – stable disease; ORR – objective response rate (complete response (CR) + PR); DCR – disease control rate (CR + PR + SD).
Among the 37 subjects in the dose escalation phase and dose expansion phase of the Phase 1 vebreltinib clinical trial, no occurrence of dose-limiting toxicity (“DLT”) and maximum tolerated dose (“MTD”) were observed, and the drug-related adverse events (“AE”) were mainly Common Terminology for Adverse Events (“CTCAE”) grade 1-2.
Among the 37 subjects in the dose escalation phase and dose expansion phase of the Phase 1 vebreltinib clinical trial, no occurrence of dose-limiting toxicity and maximum tolerated dose (“MTD”) were observed, and the drug-related adverse events (“AE”) were mainly Common Terminology for Adverse Events grade 1-2.
However, additional epidemiologic information on high grade glioma with PTPRZ1-MET fusion and more detailed information on the Phase 2/3 study completed by Avistone are needed to be provided to FDA to determine if this study, supported by data from SPARTA study, could be sufficient to support a marketing authorization for this indication in the US, or if additional clinical trial data would be required.
However, additional epidemiologic information on high grade glioma with PTPRZ1-MET fusion and more detailed information on the Phase 2/3 study completed by Avistone are needed to be provided to the FDA to determine if this study, supported by data from the SPARTA study, could be sufficient to support a marketing authorization for this indication in the United States, or if additional clinical trial data would be required.
The incidence of treatment-related TEAEs based on the data from SPARTA-II and KUNPENG that was presented at the NACLC meeting December 2023 was generally similar between two studies; treatment-related TEAEs of grade 3 or higher were reported in 42.2% of patients, with the most common being edema (13.3%) and ALT increase (7.2%). Market Opportunity and Competition NSCLC .
The incidence of treatment-related TEAEs based on the data from SPARTA-II and KUNPENG that was presented at the NACLC meeting December 2023 was generally similar between two studies; treatment-related TEAEs of grade 3 or higher were reported in 42.2% of patients, with the most common being edema (13.3%) and ALT increase (7.2%). 62 Table of Contents Market Opportunity and Competition NSCLC .
A biosimilar product may be deemed interchangeable with a previously approved product if it meets the higher hurdle of demonstrating that it can be expected to produce the same clinical results as the reference product 95 Table of Contents and, for products administered multiple times, the biologic and the reference biologic may be switched after one has been previously administered without increasing safety risks or risks of diminished efficacy relative to exclusive use of the reference biologic.
A biosimilar product may be deemed interchangeable with a previously approved product if it meets the higher hurdle of demonstrating that it can be expected to produce the same clinical results as the reference product and, for products administered multiple times, the biologic and the reference biologic may be switched after one has been previously administered without increasing safety risks or risks of diminished efficacy relative to exclusive use of the reference biologic.
We plan to pursue seeking marketing authorizations in the US for NSCLC with Met Exon 14 skipping indication and the NSCLC with c-Met amplification indication with clinical results from the relevant patient subgroup from our APL-101-01 (SPARTA) study and patients from Avistone’s Phase 2 study in NSCLC patients, following pre-NDA meeting with the FDA upon data maturation for each of these two indications.
We plan to pursue seeking marketing authorizations in the United States for NSCLC with Met Exon 14 skipping indication and the NSCLC with c-Met amplification indication with clinical results from the relevant patient subgroup from our APL-101-01 (SPARTA) study and patients from Avistone’s Phase 2 study in NSCLC patients, following the pre-NDA meeting with the FDA upon data maturation for each of these two indications.
Following oral administration, treatment with APL-122 resulted in a statistically significant improvement in outcomes compared to positive and negative controls in both CNS and systemic tumor models. APL-122 was well-tolerated with no gastrointestinal side effects observed at efficacious doses in these models. In rodent studies in vivo , APL-122 exhibited a half-life of 16–20 hours.
Following oral administration, treatment with APL-122 resulted in a statistically significant improvement in outcomes compared to positive and negative controls in both CNS and systemic tumor models. APL-122 was well-tolerated with no gastrointestinal side effects observed at efficacious doses in these models. In rodent studies in vivo , 65 Table of Contents APL-122 exhibited a half-life of 16–20 hours.
Additionally, the FDA recommended that we request an additional meeting when more data is available to discuss: 1) the data package needed to support a marketing application seeking accelerated approval, and 2) plans for confirming the clinical benefit of vebreltinib. The FDA also provided guidance on sample size requirements and study endpoints.
Additionally, the FDA recommended that we request an additional meeting when more data is available to discuss: 1) the data package needed to support a marketing application seeking accelerated approval, and 2) plans for confirming the clinical benefit of vebreltinib. The FDA also provided guidance on sample size 59 Table of Contents requirements and study endpoints.
Based on the databases of the relevant patent offices, the ownership of patent rights covering vebreltinib outside China, Hong Kong and Macau, the ownership of patent rights covering APL-501 outside China, the ownership of patent rights covering the molecule of APL-502 outside China, and the ownership of patent rights covering the molecule of APL-102 have been fully transferred to our Company, and there are no circumstances where third party assertions of inventorship may affect our entitlement to these intellectual 77 Table of Contents property rights.
Based on the databases of the relevant patent offices, the ownership of patent rights covering vebreltinib outside China, Hong Kong and Macau, the ownership of patent rights covering APL-501 outside China, the ownership of patent rights covering the molecule of APL-502 outside China, and the ownership of patent rights covering the molecule of APL-102 have been fully transferred to our Company, and there are no circumstances where third party assertions of inventorship may affect our entitlement to these intellectual property rights.
However, the FDA generally releases lots within 30 business days once a complete and accurate submission has been received. As with drugs, after approval of a BLA, biologics manufacturers must address any safety issues that arise, are subject to recalls or a halt in manufacturing, and are subject to periodic inspection after approval.
However, the FDA generally releases lots within 30 business days once a complete and accurate submission has been received. As with drugs, after 80 Table of Contents approval of a BLA, biologics manufacturers must address any safety issues that arise, are subject to recalls or a halt in manufacturing, and are subject to periodic inspection after approval.
Vebreltinib (APL-101), our orally-available c-Met Inhibitor As of the date of this Annual Report, throughout the world, NSCLC with Met Exon 14 skipping is the only indication which some of these c-Met TKIs are approved despite the potential application of c-Met inhibitors towards treatment of tumors with other c-Met mutations/ dysregulations, such as c-Met amplifications and Met fusions.
Vebreltinib, our orally-available c-Met Inhibitor As of the date of this Annual Report, throughout the world, NSCLC with Met Exon 14 skipping is the only indication for which some of these c-Met TKIs are approved despite the potential application of c-Met inhibitors towards treatment of tumors with other c-Met mutations/dysregulations, such as c-Met amplifications and Met fusions.
For patents listed that claim an approved method of use, under certain circumstances the ANDA applicant may also elect to 94 Table of Contents submit a section viii statement certifying that its proposed ANDA label does not contain (or carves out) any language regarding the patented method-of-use rather than certify to a listed method-of-use patent.
For patents listed that claim an approved method of use, under certain circumstances the ANDA applicant may also elect to submit a section viii statement certifying that its proposed ANDA label does not contain (or carves out) any language regarding the patented method-of-use rather than certify to a listed method-of-use patent.
The federal Anti-Kickback Statute prohibits, among other things, knowingly and willfully offering, paying, soliciting or receiving remuneration to induce, or in return for, purchasing, leasing, ordering or arranging for the purchase, lease or order of any healthcare item or service reimbursable under Medicare, Medicaid, or other federally financed healthcare programs.
The federal Anti-Kickback Statute prohibits, among other things, knowingly and willfully offering, paying, soliciting or receiving remuneration to induce, or in return for, purchasing, leasing, ordering or arranging for the purchase, lease or order of any 83 Table of Contents healthcare item or service reimbursable under Medicare, Medicaid, or other federally financed healthcare programs.
Of the first 83 NSCLC patients with MetExon14 63 Table of Contents skipping mutation with available gene copy number (“GCN”) data from the Phase 2 KUNPENG and SPARTA trials, 91.6% did not have co-occurring MET amplifications, reflecting the real-world distribution of the NSCLC patients with MetExon14 skipping mutation from two large public databases (83.6% and 91.9%).
Of the first 83 NSCLC patients with MetExon14 skipping mutation with available gene copy number (“GCN”) data from the Phase 2 KUNPENG and SPARTA trials, 91.6% did not have co-occurring MET amplifications, reflecting the real-world distribution of the NSCLC patients with MetExon14 skipping mutation from two large public databases (83.6% and 91.9%).
Unless earlier terminated by either party due to the other party’s material breach (subject to specified conditions), the Genor Agreement remains effective until the later of (i) the full 78 Table of Contents performance of rights and obligations of both parties thereto, and (ii) the expiration of the last patent covering the intellectual property licensed thereunder.
Unless earlier terminated by either party due to the other party’s material breach (subject to specified conditions), the Genor Agreement remains effective until the later of (i) the full performance of rights and obligations of both parties thereto, and (ii) the expiration of the last patent covering the intellectual property licensed thereunder.
We also owned five pending applications. The issued patents are expected to expire in 2033, before taking into account any extension that may be obtained through patent term extension or adjustment, or term reduction due to filing of terminal disclaimers. • APL-122 . We did not own any issued patent or patent application directed to APL-122.
We also own five pending applications. The issued patents are expected to expire in 2033, before taking into account any extension that may be obtained through patent term extension or adjustment, or term reduction due to filing of terminal disclaimers. • APL-122 . We do not own any issued patent or patent application directed to APL-122.
Despite any measures taken to protect our data and intellectual property, unauthorized parties may attempt to or successfully gain access to and use information that we regard as proprietary. Please refer to the section entitled “ Risk Factors-Risks Related to our Intellectual Property Rights ” for a description of risks related to our intellectual property.
Despite any measures taken to protect our data and intellectual property, unauthorized parties may attempt to or successfully gain access to and use information that we regard as proprietary. Please refer to the section entitled Item 3.D. “ Risk Factors—Risks Related to our Intellectual Property Rights ” for a description of risks related to our intellectual property.
Once granted, PMA approval may be withdrawn by the FDA if compliance with post approval requirements, conditions of approval or other regulatory standards are not maintained, or problems are identified following initial marketing. 96 Table of Contents After a device is placed on the market, it remains subject to significant regulatory requirements.
Once granted, PMA approval may be withdrawn by the FDA if compliance with post approval requirements, conditions of approval or other regulatory standards are not maintained, or problems are identified following initial marketing. After a device is placed on the market, it remains subject to significant regulatory requirements.
Our pipeline includes a variety of cancer treatment programs that utilize tumor inhibitors, cell adhesion inhibitors, immune checkpoint inhibitors, a cancer vaccine, monotherapies, combination therapies or a multi-functional protein with the goals to improve response rates and reduce chemo-resistance and toxicity compared to the current treatment standards.
Our pipeline includes a variety of cancer treatment programs that utilize tumor inhibitors, cell adhesion inhibitors, immune checkpoint inhibitors, a cancer vaccine, monotherapies, combination therapies or a multi-functional protein with the goals to improve 48 Table of Contents response rates and reduce chemo-resistance and toxicity compared to the current treatment standards.
On March 8, 2017, we (then known as CB Therapeutics, Inc.) entered into a tri-party agreement with Crown Bioscience (Taicang) and CTTQ (the “Tri-party CTTQ Agreement”), pursuant to which CTTQ is obliged to provide data and materials directly to us that we may reasonably request and collaborate with us and our affiliates in good faith in developing APL-502, according to the CTTQ Technology Agreement.
On March 8, 2017, we (then known as CB Therapeutics, Inc.) entered into a tri-party agreement with Crown Bioscience (Taicang) and CTTQ (the “Tri-party CTTQ Agreement”), pursuant to which CTTQ is obliged to provide data and materials directly to us that we may reasonably request and collaborate with us and our affiliates in good faith in developing APL-502, according to the CTTQ 69 Table of Contents Technology Agreement.
Please refer to the section headed “ Risk Factors-Risks Related to Our Intellectual Property Rights-If we are sued for infringing, misappropriating, or otherwise violating intellectual property rights of third parties or engaging in unfair competition, such litigation could be costly and time-consuming and could prevent or delay us from developing or commercializing our product candidates. ” for a description of risks related to the development and commercialization of our product candidates.
“ Risk Factors—Risks Related to Our Intellectual Property Rights—If we are sued for infringing, misappropriating, or otherwise violating intellectual property rights of third parties or engaging in unfair competition, such litigation could be costly and time-consuming and could prevent or delay us from developing or commercializing our product candidates. ” for a description of risks related to the development and commercialization of our product candidates.
NSCLC with c-Met amplification; and 3. GBM with c-Met dysregulation. NSCLC with c-Met dysregulation indications: Met Exon 14 skipping and those with c-Met amplification Lung cancer is a leading cause of cancer death, and NSCLC comprises 85% of lung cancers.
NSCLC with c-Met dysregulation indications: Met Exon 14 skipping and those with c-Met amplification Lung cancer is a leading cause of cancer death, and NSCLC comprises 85% of lung cancers.
Failure of an application to meet any of these criteria will result in the application not being approvable by the FDA based on the foreign data alone. The FDA applies this policy in a flexible manner according to the nature of the drug and the data being considered.
Failure of an application to meet any of these criteria will result in the application not being 78 Table of Contents approvable by the FDA based on the foreign data alone. The FDA applies this policy in a flexible manner according to the nature of the drug and the data being considered.
We believe that having three groups of product candidates with different mechanisms of action will enable us to develop potential synergistic therapies that address unmet needs in cancer treatment. Tumor Inhibitors Our tumor inhibitor product candidates consist of three small molecule inhibitors against different uncontrolled growth signaling pathways in cancer cells: vebreltinib, APL-102 and APL-122.
We believe that having two groups of product candidates with different mechanisms of action will enable us to develop potential synergistic therapies that address unmet needs in cancer treatment. Active Development Programs: Tumor Inhibitors Our tumor inhibitor product candidates consist of three small molecule inhibitors against different uncontrolled growth signaling pathways in cancer cells: vebreltinib, APL-102 and APL-122.
Prior to making a written commitment to a commercial partner, we intend to maintain the option of developing internal sales and marketing capabilities to commercialize ourselves in the best interest of the business. Intellectual Property Intellectual property rights are important to the success of our business.
Prior to making a written commitment to a commercial partner, we intend to maintain the option of developing internal sales and marketing capabilities to commercialize ourselves in the best interest of the business. 72 Table of Contents Intellectual Property Intellectual property rights are important to the success of our business.
As of the date of this Annual Report, there are over 250 subjects enrolled in the SPARTA study, including subjects with NSCLC with Met Exon 14 skipping or with MET amplification, brain tumors with PTPRZ1-MET fusion, and subjects with other solid tumors with MET alterations like MET amplification or MET fusion.
As of the date of this Annual Report, over 250 subjects have enrolled in the SPARTA study, including subjects with NSCLC with Met Exon 14 skipping or with MET amplification, brain tumors with PTPRZ1-MET fusion, and subjects with other solid tumors with MET alterations like MET amplification or MET fusion.
We have been monitoring and will continue to monitor on a monthly basis the prosecution 88 Table of Contents and legal status of the Withdrawn Method Patent Application on the official website of European Patent Office to assess the necessity to communicate with the patent owner.
We have been monitoring and will continue to monitor on a monthly basis the prosecution and legal status of the Withdrawn Method Patent Application on the official website of European Patent Office to assess the necessity to communicate with the patent owner.
Vebreltinib received approval from the NMPA in November 2023. c-Met amplification c-Met amplification has been found to occur in many solid tumors. In NSCLC, amplification of MET typically occurs in about 2% to 5% of newly diagnosed adenocarcinomas.
Vebreltinib received approval from the NMPA in November 2023. 52 Table of Contents c-Met amplification c-Met amplification has been found to occur in many solid tumors. In NSCLC, amplification of MET typically occurs in about 2% to 5% of newly diagnosed adenocarcinomas.
We owned one issued U.S. patent and six issued patents in other jurisdictions. We also owned four pending U.S. patent applications, three pending Chinese patent application, and sixteen pending patent applications in other jurisdictions.
We own one issued U.S. patent and six issued patents in other jurisdictions. We also own four pending U.S. patent applications, three pending Chinese patent application, and sixteen pending patent applications in other jurisdictions.
Investments in our securities are not purchases of equity securities of these operating subsidiaries in the United States or the PRC but instead are purchases of equity securities of a Cayman Islands holding company with no material 106 Table of Contents operations of its own.
Investments in our securities are not purchases of equity securities of these operating subsidiaries in the United States or the PRC but instead are purchases of equity securities of a Cayman Islands holding company with no material operations of its own.
For GBM with PTPRZ1-Met fusion, FDA acknowledged PTPRZ1-MET fusion-positive high-grade glioma is a serious illness with an unmet medical need where effective agents that prolong OS in the context of an adequately powered randomized trial could be considered for traditional approval.
In our February 2024 meeting with the FDA, for GBM with PTPRZ1-Met fusion, the FDA acknowledged PTPRZ1-MET fusion-positive high-grade glioma is a serious illness with an unmet medical need where effective agents that prolong OS in the context of an adequately powered randomized trial could be considered for traditional approval.
Subject to specified notice period, we may terminate the CTTQ Sublicense Agreement by written notice for 79 Table of Contents convenience. Either party may, subject to specified cure periods, terminate the CTTQ Sublicense Agreement in the event of the other party’s uncured material breach.
Subject to specified notice period, we may terminate the CTTQ Sublicense Agreement by written notice for convenience. Either party may, subject to specified cure periods, terminate the CTTQ Sublicense Agreement in the event of the other party’s uncured material breach.
This is taking place in our ongoing 54 Table of Contents Phase 2 global study as well as ongoing Phase 2 studies conducted by our partner, Avistone. We are also exploring, in an investigator-sponsored study, combination therapy using vebreltinib with an EGFR inhibitor mutation to reduce treatment resistance.
This is taking place in our ongoing Phase 2 global study as well as in ongoing Phase 2 studies conducted by our partner, Avistone. We are also exploring, in an investigator-sponsored study, combination therapy using vebreltinib with an EGFR inhibitor mutation to reduce treatment resistance.
Both Apollomics and Avistone have been advancing the development (CMC, preclinical, and clinical) of vebreltinib for the treatment of solid tumors with c-Met alterations. To date, more than 500 patients and 170 healthy volunteers have been dosed with vebreltinib. The safety profile is generally acceptable.
Both Apollomics and Avistone have been advancing the development (CMC, preclinical, and clinical) of vebreltinib for the treatment of solid tumors with c-Met alterations. To date, more than 600 patients and 170 healthy volunteers have been dosed with vebreltinib in clinical trials. The safety profile is generally acceptable.
In 67 Table of Contents addition, since c-Met amplification accounts for approximately 20% of the acquired resistance to EGFR-TKIs in NSCLC patients with EGFR mutation, c-Met inhibitors have the potential to overcome such resistance in these patients.
In addition, since c-Met amplification accounts for approximately 20% of the acquired resistance to EGFR-TKIs in NSCLC patients with EGFR mutation, c-Met inhibitors have the potential to overcome such resistance in these patients.
We are aware of numerous issued patents and pending patent applications belonging to third parties that exist in fields in which we are developing our product candidates. In particular: The Structure Patents .
We are aware of numerous issued patents and pending patent applications belonging to third parties that exist in fields in which we are developing our product candidates. In particular: 74 Table of Contents The Structure Patents .
For NSCLC with c-Met amplification, at the February 2024 meeting the FDA acknowledged that pretreated patents in this setting remains an unmet medical need, and indicated that the preliminary data presented could represent an improvement over available therapy.
NSCLC with Met Amplification For NSCLC with c-Met amplification, at the February 2024 meeting, the FDA acknowledged that pretreated patients in this setting remain an unmet medical need, and indicated that the preliminary data presented could represent an improvement over available therapy.

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Item 5. Market for Registrant's Common Equity

Market for Common Equity — stock, dividends, buybacks

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Biggest changeRes ults of Operations The results of operations presented below should be reviewed in conjunction with the consolidated financial statements and notes included elsewhere in this Annual Report. 110 Table of Contents The following table presents Apollomics’ consolidated statements of profit or loss and other comprehensive loss data for the years ended December 31, 2021, 2022 and 2023: Years ended December 31, (Amounts in thousands) 2021 2022 2023 Other income $ 1,054 $ 1,447 $ 1,217 Other gains and losses 36 (829 ) 1,191 Fair value change of financial assets at fair value through profit or loss (“FVTPL”) 2 323 821 Fair value change of financial liabilities at FVTPL — — 1,597 Fair value change of convertible preferred shares (37,424 ) (189,646 ) (76,430 ) Research and development expenses (35,568 ) (35,457 ) (34,193 ) Administrative expenses (15,291 ) (9,947 ) (20,641 ) Impairment loss of an intangible asset (3,000 ) — — Finance costs (83 ) (93 ) (150 ) Other expense (4,522 ) (6,608 ) (46,003 ) Loss before taxation (94,796 ) (240,810 ) (172,591 ) Income tax credit (expenses) (85 ) (1 ) (10 ) Loss and total comprehensive expenses for the year, attributable to owners of the Company $ (94,797 ) $ (240,811 ) $ (172,601 ) Year Ended December 31, 2022 Compared to Year Ended December 31, 2023 Other Income The following table summarizes the components of our other income for the years ended December 31, 2022 and 2023: Years ended December 31, Change (In thousands, except percentages) 2022 2023 $ % Interest income $ 431 $ 753 $ 322 74.7 % Government grants 1,016 464 (552 ) (54.3 )% Total $ 1,447 $ 1,217 $ (230 ) (15.9 )% Other income was $1.4 million for the year ended December 31, 2022, compared to $1.2 million for the year ended December 31, 2023.
Biggest changeConsequently, numerical figures shown as totals in some tables or discussed below may not be arithmetic aggregations of the figures that precede them. 89 Table of Contents The following table presents Apollomics’ consolidated statements of loss and other comprehensive loss data for the years ended December 31, 2022, 2023 and 2024: Years ended December 31, (Amounts in thousands) 2022 2023 2024 Other income $ 1,447 $ 1,217 $ 1,489 Other gains and losses (829 ) 1,191 145 Fair value change of financial assets at fair value through profit and loss (“FVTPL”) 323 821 198 Fair value change of financial liabilities at FVTPL — 1,597 222 Fair value change of convertible preferred shares (189,646 ) (76,430 ) — Research and development expenses (35,457 ) (34,193 ) (24,566 ) Administrative expenses (9,947 ) (20,641 ) (17,768 ) Impairment of intangible assets — — (13,000 ) Finance costs (93 ) (150 ) (179 ) Other expense (6,608 ) (46,003 ) (140 ) Loss before taxation (240,810 ) (172,591 ) (53,599 ) Income tax expenses (1 ) (10 ) (259 ) Loss and total comprehensive expenses for the year, attributable to owners of the Company $ (240,811 ) $ (172,601 ) $ (53,858 ) Year Ended December 31, 2023 Compared to Year Ended December 31, 2024 Other Income The following table summarizes the components of our other income for the years ended December 31, 2023 and 2024: Years ended December 31, Change (In thousands, except percentages) 2023 2024 $ % Interest income $ 753 $ 480 $ (273 ) (36.3 )% Government grants 464 301 (163 ) (35.1 )% Other income — 708 708 100.0 % Total $ 1,217 $ 1,489 $ 272 22.4 % Other income was $1.2 million for the year ended December 31, 2023, compared to $1.5 million for the year ended December 31, 2024.
Other Gains and Losses The following table summarizes the component of our other gains and losses for the year ended December 31, 2022 and 2023: Years ended December 31, Change 2022 2023 $ % Exchange loss, net $ (829 ) $ 1,191 $ 2,020 >100% Other gains and losses reflects a loss of $(829) thousand for the year ended December 31, 2022, compared to a gain of $1.2 million for the year ended December 31, 2023.
Other Gains and Losses The following table summarizes the component of our other gains and losses for the years ended December 31, 2022 and 2023: Years ended December 31, Change 2022 2023 $ % Exchange loss, net $ (829 ) $ 1,191 $ 2,020 >100% Other gains and losses reflects a loss of $(829) thousand for the year ended December 31, 2022, compared to a gain of $1.2 million for the year ended December 31, 2023.
In addition, we will require additional capital, from equity, debt or strategic partnerships, to continue as a going concern in the future. It is uncertain whether such capital will be available in amounts or on terms acceptable to us, if at all.
In addition, we will require additional capital, from equity, debt or strategic partnerships, to continue as a going concern in the future. It is uncertain whether such capital will be available in amounts or on terms acceptable to us, if at all.
If we are not able to obtain additional capital to meet our cash requirements in the future, our business, financial condition, results of operations and prospects could be materially and adversely affected.
If we are not able to obtain additional capital to meet our cash requirements in the future, our business, financial condition, results of operations and prospects could be materially and adversely affected.
We expect that our financial performance will fluctuate quarterly and yearly due to the development status of our drug candidates, our efforts to obtain regulatory approval and commercialize our drug candidates. In January 2024, we implemented significant expense reductions, where we have prioritized the development of vebreltinib and uproleselan, as well as reduced other operating expenses.
We expect that our financial performance will fluctuate quarterly and yearly due to the development status of our drug candidates, our efforts to obtain regulatory approval and commercialize our drug candidates. In January 2024, we implemented significant expense reductions, where we prioritized the development of vebreltinib and uproleselan, as well as reduced other operating expenses.
We expect to incur significant additional expenses related to compliance with the rules and regulations of the SEC, Sarbanes Oxley Act, and the listing standards of Nasdaq, additional corporate, director and officer insurance expenses, increased legal, audit and consulting fees and greater investor relations expenses.
We incur significant additional expenses related to compliance with the rules and regulations of the SEC, Sarbanes Oxley Act, and the listing standards of Nasdaq, additional corporate, director and officer insurance expenses, increased legal, audit and consulting fees and greater investor relations expenses.
Net cash used in operating activities was $(43.2) million for the year ended December 31, 2023, resulting primarily from a net loss of $(172.6) million, adjusted for non-cash charges of $0.7 million in depreciation and amortization including depreciation of operating right-of-use of assets, $0.2 million in loss on disposal of fixed assets, $12.7 million in share-based payments, $76.4 million in negative fair value change of our convertible preferred shares, $45.5 million in IFRS 2 listing expenses, $(0.3) million in unrealized foreign currency 115 Table of Contents loss, $0.1 million in finance costs, and partially offset by $(0.8) million in interest income, $(1.6) million in the fair value change of financial liabilities through FVTPL, and $3.6 million in working capital adjustments.
Net cash used in operating activities was $(43.2) million for the year ended December 31, 2023, resulting primarily from a net loss of $(172.6) million, adjusted for non-cash charges of $0.7 million in depreciation and amortization including depreciation of operating right-of-use of assets, $0.2 million in loss on disposal of fixed assets, $12.7 million in share-based payments, $76.4 million in negative fair value change of our convertible preferred shares, $45.5 million in IFRS 2 listing expenses, $(0.3) million in unrealized foreign currency loss, $0.1 million in finance costs, and partially offset by $(0.8) million in interest income, $(1.6) million in the fair value change of financial liabilities through FVTPL, and $3.6 million in working capital adjustments.
Net cash provided by investing activities was $29.1 million for the year ended December 31, 2022 resulting primarily from the proceeds from our time deposits with original maturity over three months of $24 million, proceeds of disposal of financial asset at FVTPL of $5 million and interest received for $431 thousand, offset by additions of plant and equipment of ($367) thousand and ($11) thousand payment of rental deposits.
Cash Flows From Investing Activities Net cash provided by investing activities was $29.1 million for the year ended December 31, 2022 resulting primarily from the proceeds from our time deposits with original maturity over three months of $24.0 million, proceeds of disposal of financial asset at FVTPL of $5.0 million and interest received for $431 thousand, offset by additions of plant and equipment of ($367) thousand and ($11) thousand payment of rental deposits.
We will remain an EGC under the JOBS Act until the earliest of (i) the last day of the fiscal year in which the market value of our Class A Ordinary Shares that are held by non-affiliates exceeds $700 million as of the last business day of the second quarter of that fiscal year, (ii) the last day of the fiscal year in which it has total annual gross revenue of $1.235 billion or more during such fiscal year (as indexed for inflation), (iii) the date on which it has issued more than $1 billion in non-convertible debt in the prior three-year period or (iv) the last day of the fiscal year following the fifth anniversary of the date of the Closing. 118 Table of Contents
We will remain an EGC under the JOBS Act until the earliest of (i) the last day of the fiscal year in which the market value of our Class A Ordinary Shares that are held by non-affiliates exceeds $700 million as of the last business day of the second quarter of that fiscal year, (ii) the last day of the fiscal year in which it has total annual gross revenue of $1.235 billion or more during such fiscal year (as indexed for inflation), (iii) the date on which it was issued more than $1 billion in non-convertible debt in the prior three-year period or (iv) the last day of the fiscal year following the fifth anniversary of the date of the Closing. 96 Table of Contents
Net cash provided by investing activities was $21.4 million for the year ended December 31, 2023 resulting primarily from the proceeds from disposal of our financial assets held at fair value for $13.3 million, proceeds from redemption of our long term time deposits with original maturity over three months for $4.3 million, proceeds from redemption of our short term time deposits with original maturity over three months for $2.9 million, and interest received on such redemptions for $0.8 million, and proceeds from disposal of plant and equipment for $0.1 million.
Net cash provided by investing activities was $21.4 million for the year ended December 31, 2023 resulting primarily from the proceeds from disposal of our financial assets held at fair value for $13.3 million, proceeds from redemption of our long term time deposits with original maturity over three months for $4.3 million, proceeds from redemption of our short term time deposits with original maturity over 94 Table of Contents three months for $2.9 million, and interest received on such redemptions for $0.8 million, and proceeds from disposal of plant and equipment for $0.1 million.
Development costs incurred on our research and development projects are capitalized and deferred only when we can demonstrate the technical feasibility of completing the intangible asset so that it will be available for use or sale, our intention to complete and our ability to use or sell the asset, how the asset will generate future economic benefits, the availability of resources to complete the pipeline and the ability to measure reliably the expenditure during the development.
Development costs incurred on our R&D projects are capitalized and deferred only when we can demonstrate the technical feasibility of completing the intangible asset so that it will be available for use or sale, our intention to complete and our ability to use or sell the asset, how the asset will generate future economic benefits, the availability of resources to complete the pipeline and the ability to measure reliably the expenditure during the development.
Administrative Expenses The following table summarizes the components of our administrative expenses for the years ended December 31, 2022 and 2023: Years ended December 31, Change (Amounts in thousands, except percentages) 2022 2023 $ % Administrative Employee Other Compensation and Benefits $ 5,028 $ 3,480 $ (1,548 ) (30.8 )% Administrative Employee Share-Based Compensation 602 6,810 6,208 1,031.3 % Administrative Third-Party Service Fees 1,536 5,389 3,852 250.8 % Operations 524 452 (72 ) (13.7 )% Sales and Marketing Expenses 37 77 39 106.6 % Travel Expenses 203 261 58 28.8 % Facilities 415 251 (164 ) (39.6 )% Depreciation and amortization 781 694 (87 ) (11.2 )% Others 821 3,227 2,406 293.1 % Total $ 9,947 $ 20,641 $ 10,694 107.5 % Administrative expenses were $9.9 million for the year ended December 31, 2022, compared to $20.6 million for the year ended December 31, 2023.
Administrative Expenses The following table summarizes the components of our administrative expenses for the years ended December 31, 2022 and 2023: 92 Table of Contents Years Ended December 31, Change (Amounts in thousands, except percentages) 2022 2023 $ % Administrative Employee Compensations and Benefits $ 5,028 $ 3,480 $ (1,548 ) (30.8 )% Administrative Employee Share Based Compensation 602 6,810 6,208 1,031.2 % Administrative Third-Party Service Fees 1,536 5,389 3,853 250.8 % Operations 524 452 (72 ) (13.7 )% Sales and Marketing Expenses 37 77 39 106.6 % Travel Expenses 203 261 58 28.6 % Facilities 415 251 (164 ) (39.6 )% Depreciation and amortization 781 694 (87 ) (11.2 )% Others 821 3,227 2,406 293.1 % Total $ 9,947 $ 20,641 $ 10,694 107.5 % Administrative expenses were $9.9 million for the year ended December 31, 2022, compared to $20.6 million for the year ended December 31, 2023.
For example, if the FDA or another regulatory authority were to require us to conduct clinical trials beyond those that we currently anticipate will be required for the 109 Table of Contents completion of the clinical development of therapeutic candidates, or if we experience significant delays in the enrollment in any clinical trials, we could be required to expend significant additional financial resources and time on the completion of clinical development.
For example, if the FDA or another regulatory authority were to require us to conduct clinical trials beyond those that we currently anticipate will be required for the completion of the clinical development of therapeutic candidates, or if we experience significant delays in the enrollment in any clinical trials, we could be required to expend significant additional financial resources and time on the completion of clinical development.
Because of the numerous risks and uncertainties associated with the development and commercialization of our product candidates and the extent to which we may enter into additional collaborations with third parties to participate in their development and commercialization, we are unable to estimate the amounts of increased capital outlays and operating expenditures associated with our current and anticipated preclinical studies and clinical trials.
Because of the numerous risks and uncertainties associated with the development and commercialization of our product candidates and the extent to which we may enter into additional collaborations with third parties to participate in their development and commercialization, we are unable to estimate the amounts of increased capital 93 Table of Contents outlays and operating expenditures associated with our current and anticipated preclinical studies and clinical trials.
The decrease of $(0.2) million, or 15.9%, was mainly from a decrease of $(0.6) million subsidies received from the Australian government specifically for supporting the research and development activities carried out in Australia offset by a $0.3 million increase in interest income in China upon the maturity of two time deposits.
The decrease of $(0.2) million, or 15.9%, was mainly from a decrease of $(0.6) million subsidies received from the Australian government specifically for supporting the R&D activities carried out in Australia offset by a $0.3 million increase in interest income in China upon the maturity of two time deposits.
If we are unable to obtain adequate financing when needed, we may have to delay, reduce the scope of or suspend one or more of our preclinical studies and clinical trials, research and development programs or commercialization efforts.
If we are unable to obtain adequate financing when needed, we may have to delay, reduce the scope of or suspend one or more of our preclinical studies and clinical trials, R&D programs or commercialization efforts.
Research and Development We conduct our business operations through Apollomics US, at its headquarters in the United States, and through our wholly-owned subsidiaries in the PRC. These operating subsidiaries conduct research and development activities relating to the biologics of oncology, to facilitate the discovery and development of product candidates and expand our global presence.
Research and Development We conduct our business operations through Apollomics U.S., at its headquarters in the United States, and through our wholly-owned subsidiaries in the PRC. These operating subsidiaries conduct R&D activities relating to the biologics of oncology, to facilitate the discovery and development of product candidates and expand our global presence.
The only costs we track by each therapeutic candidate are external costs such as services provided to us by CROs, manufacturing of preclinical and clinical drug products, and other outsourced research and development expenses.
The only costs we track by each therapeutic candidate are external costs such as services provided to us by CROs, manufacturing of preclinical and clinical drug products, and other outsourced R&D expenses.
For the years ended December 31, 2022 and 2023, we had an accumulated deficit of $474.6 million and $647.0 million, respectively. In January 2024, we implemented significant expense reductions, where we have prioritized the development of vebreltinib and uproleselan, as well as reduced other operating expenses.
For the years ended December 31, 2023 and 2024, we had an accumulated deficit of $647.0 million and $700.8 million, respectively. In January 2024, we implemented significant expense reductions, where we prioritized the development of vebreltinib and uproleselan, as well as reduced other operating expenses.
The decrease of $113.2 million, or 60%, is due to the increase in the fair value of the convertible preferred shares upon the completion of the business combination. 111 Table of Contents Research and Development Expenses The following table summarizes the components of our research and development expenses for the years ended December 31, 2022 and 2023: Year Ended December 31, Change (Amounts in thousands, except percentages) 2022 2023 $ % APL-101 $ 16,767 $ 16,234 $ (533 ) (3.2 )% APL-102 385 144 (241 ) (62.6 )% APL-106 3,014 2,621 (393 ) (13.0 )% APL-121 93 — (93 ) (100.0 )% APL-122 717 274 (443 ) (61.8 )% APL-501 1,600 1,669 69 4.3 % Discovery & other 975 — (975 ) (100.0 )% R&D Third-Party Service Fees and Contractor Expenses: $ 23,551 $ 20,942 $ (2,609 ) (11.1 )% R&D Employee Other Compensation and Benefits 9,532 7,376 (2,156 ) (22.6 )% R&D Employee Share-Based Compensation 2,374 5,875 3,501 147.5 % Total Research and Development Expenses $ 35,457 $ 34,193 $ (1,264 ) (3.6 )% Research and development expenses for the year ended December 31, 2022 was $35.5 million, compared to $34.2 million for the year ended December 31, 2023.
Research and Development Expenses The following table summarizes the components of our R&D expenses for the years ended December 31, 2022 and 2023: Years Ended December 31, Change (Amounts in thousands, except percentages) 2022 2023 $ % APL-101 $ 16,767 $ 16,234 $ (533 ) (3.2 )% APL-102 385 144 (241 ) (62.6 )% APL-106 3,014 2,621 (393 ) (13.0 )% APL-121 93 — (93 ) (100.0 )% APL-122 and other 717 274 (443 ) (61.8 )% APL-501 1,600 1,669 69 4.3 % Discovery & other 975 — (975 ) (100.0 )% R&D Third-Party Service Fees and Contractor Expenses: $ 23,551 $ 20,942 $ (2,609 ) (11.1 )% R&D Employee Other Compensation and Benefits 9,532 7,376 (2,156 ) (22.6 )% R&D Employee Share-Based Compensation 2,374 5,875 3,501 147.5 % Total Research and Development Expenses $ 35,457 $ 34,193 $ (1,264 ) (3.6 )% Research and development expenses for the year ended December 31, 2022 was $35.5 million, compared to $34.2 million for the year ended December 31, 2023.
Contractual Obligations and Commitments The following table summarizes our contractual obligations as of December 31, 2023, and the effects of such obligations are expected to have on our liquidity and cash flow in future periods (in thousands): Payments due by period (Amounts in thousands) Total Less than 1 year 1-2 years 2-5 years More than 5 years Lease commitments $ 425 $ 158 $ 216 $ 50 $ — Lease Commitments During the year ended December 31, 2021, we entered into new lease agreements for the use of offices, and plant and equipment for 12 months to 60 months (about five years).
Contractual Obligations and Commitments The following table summarizes our contractual obligations as of December 31, 2024, and the effects of such obligations are expected to have on our liquidity and cash flow in future periods (in thousands): Payments due by period (Amounts in thousands) Total Less than 1 year 1-2 years 2-5 years More than 5 years Lease commitments $ 966 $ 233 $ 484 $ 249 $ — Lease Commitments During the year ended December 31, 2024, we entered into new lease agreements for the use of offices, and plant and equipment for 12 months to 60 months (about five years).
In 2021 we incurred a $3.0 million impairment loss for patent rights because of the failure of the licensor’s vendor to provide drug supplies and we subsequently terminated the license. We have not incurred any impairment losses of intangible assets for the years ended December 31, 2022 and 2023.
In 2024 we incurred a $13.0 million impairment loss for patent rights because of the failure of the licensor’s vendor to provide drug supplies and we subsequently terminated the license. We did not incur any impairment losses of intangible assets for the years ended December 31, 2022 and 2023.
For the years ended December 31, 2021, 2022 and 2023, our net loss was $94.8 million, $240.8 million and $172.6 million, respectively and the fair value change of convertible preferred shares was $37.4 million, $189.6 million and $76.4 million, and an excess fair value charge of shares over fair value net assets acquired in the business combination agreement of $0, $0 and $45.5 million, respectively, leaving net loss from operations as $57.4 million, $51.2 million and $50.7 million, respectively, which resulted substantially from research and development expenses and administrative expenses.
For the years ended December 31, 2022, 2023 and 2024, our net loss was $240.8 million, $172.6 million and $53.9 million, respectively, and the fair value change of convertible preferred shares was $189.6 million, $76.4 million and $0, respectively, and an excess fair value charge of shares over fair value net assets acquired in the business combination agreement of $0, $45.5 million and $0, respectively, leaving net loss from operations as $51.2 million, $50.7 million and $53.6 million, respectively, which resulted substantially from R&D expenses and administrative expenses.
For the years ended December 31, 2022 and 2023, the fair value change of convertible preferred shares was $189.6 million and $76.4 million, respectively 108 Table of Contents Research and Development Expenses Our research and development costs primarily consist of salaries, benefits and share-based compensation for our R&D employees, and expenses for consultants and external contract research and contract manufacturing organizations.
For the years ended December 31, 2023 and 2024, the fair value change of convertible preferred shares was $76.4 million and $0, respectively Research and Development Expenses Our R&D costs primarily consist of salaries, benefits and share-based compensation for our R&D employees, and expenses for consultants and external contract research and contract manufacturing organizations.
For the years ended December 31, 2021, 2022 and 2023, our net loss was $94.8 million, $240.8 million and $172.6 million, respectively and the fair value change of convertible preferred shares was $37.4 million, $189.6 million and $76.4 million, and an excess fair value charge of shares over fair value net assets acquired in the business combination agreement of $0, $0 and $45.5 million, respectively, leaving net loss from operations as $57.4 million, $51.2 million and $50.7 million, respectively, which resulted substantially from research and development expenses and administrative expenses.
For the years ended December 31, 2022, 2023 and 2024, our net loss was $240.8 million, $172.6 million and $53.9 million, respectively and the fair value change of convertible preferred shares was $189.6 million, $76.4 million and $0, and an excess fair value charge of shares over fair value net assets acquired in the business combination agreement of $0, $45.5 million and $0, respectively, leaving net loss from operations as $51.2 million, $50.7 million and $53.6 million, respectively, which resulted substantially from R&D expenses and administrative expenses.
Net cash used in financing activities was $294 thousand for the year ended December 31, 2022 resulting primarily from the repayment of lease liabilities for $593 thousand, interest paid of $93 thousand, and offset by the proceeds on issuance of our Class A Ordinary Shares upon exercise of share options for $(392) thousand.
Cash Flows From/Used in Financing Activities Net cash used in financing activities was $294 thousand for the year ended December 31, 2022 resulting primarily from the repayment of lease liabilities for $0.6 million interest paid of $0.1 million, and offset by the proceeds on issuance of our Class A Ordinary Shares upon exercise of share options for $(0.4) million.
While we have in-house clinical 116 Table of Contents operations teams in the US and in the PRC, we have worked with and plan to continue to work with third-party CROs to monitor and manage data for our ongoing preclinical and clinical programs.
While we have in-house clinical operations teams in the United States and in the PRC, we have worked with and plan to continue to work with third-party CROs to monitor and manage data for our ongoing preclinical and clinical programs.
Based upon our 2024 operating plan, and our balance of cash, cash equivalents, and a federal money market fund of $37.8 million as of December 31, 2023, we estimate that we will have sufficient liquidity to continue as a going concern through at least December 31, 2024.
Based upon our 2025 operating plan, and our balance of cash and cash equivalents of $9.8 million as of December 31, 2024, we estimate that we will have sufficient liquidity to continue as a going concern through at least December 31, 2025.
We have adopted a biomarker-driven diagnostic approach for patient screening to increase precision in identifying patients that can potentially benefit from target therapy. Business Combination On March 29, 2023, Apollomics consummated the Business Combination with Maxpro pursuant to the Business Combination Agreement. In connection with the closing of the Business Combination, Apollomics became a publicly traded company on Nasdaq.
We have adopted a biomarker-driven diagnostic approach for patient screening to increase precision in identifying patients that can potentially benefit from target therapy. 86 Table of Contents Business Combination On March 29, 2023, Apollomics consummated the Business Combination with Maxpro pursuant to the Business Combination Agreement.
From inception through December 31, 2023, we have incurred $162.9 million in research and development expenses. We may increase our research and development expenses in the future. We manage certain activities such as clinical trial operations, manufacture of therapeutic candidates, and preclinical animal toxicology studies through third-party CROs.
From inception through December 31, 2024, we have incurred $187.5 million in R&D expenses. We may increase our R&D expenses in the future. We manage certain activities such as clinical trial operations, manufacture of therapeutic candidates, and preclinical animal toxicology studies through third-party CROs.
Ltd., formed in May 2018 and May 2020, respectively). Our strategic focus is the development of novel therapies targeting difficult to treat cancers. We use both targeted, immuno-oncology, and other innovative approaches to address a range of cancer indications, such as acute myeloid leukemia, lung cancer, brain cancer, and other solid tumors.
Our strategic focus is the development of novel therapies targeting difficult to treat cancers. We use both targeted, immuno-oncology, and other innovative approaches to address a range of cancer indications, such as lung cancer, brain cancer, and other solid tumors.
For the years ended December 31, 2022 and 2023, we had an accumulated deficit of $474.6 million and $647.0 million, respectively.
For the years ended December 31, 2023 and 2024, we had an accumulated deficit of $647.0 million and $700.8 million, respectively.
In 2022 and 2023 other expenses primarily include professional fees incurred by us in relation to the business combination transaction. In 2023 we also incurred an excess fair value charge of shares over fair value net assets acquired in the business combination agreement of $45.5 million.
In 2023 we also incurred an excess fair value charge of shares over fair value net assets acquired in the business combination agreement of $45.5 million. In 2024, other expenses related to professional fees and filing fees.
Based upon our 2024 operating plan, and our balance of cash, cash equivalents, and a federal money market fund of $37.8 million as of December 31, 2023, we estimate that we will have sufficient liquidity to continue as a going concern through December 31, 2024.
Based upon our 2025 operating plan, and our balance of cash and cash equivalents of $9.8 million as of December 31, 2024, we estimate that we will have sufficient liquidity to continue as a going concern through at least December 31, 2025.
Fair Value Change of Financial Assets at Fair Value Through Profit or Loss (“FVTPL”) Fair value change of financial assets at FVTPL consists of non-cash impacts on our profit or loss as a result of the fair value change of our investment in a money market fund in the U.S. which solely holds investments in U.S. treasury bonds.
Foreign Exchange Losses Foreign exchange losses are a result of foreign exchange rate fluctuation. 87 Table of Contents Fair Value Change of Financial Assets at Fair Value Through Profit or Loss (“FVTPL”) Fair value change of financial assets at FVTPL consisted of non-cash impacts on our profit or loss as a result of the fair value change of our investment in a money market fund in the United States which solely holds investments in U.S. treasury bonds.
Key Factors Affecting Apollomics’ Operating Results We believe that our future performance and success depends to a substantial extent on our product candidate pipeline and the development of our product candidates, each of which is in turn subject to significant risks and challenges, including those discussed in Section 4 and in the section of this Annual Report entitled “ Risk Factors .” We currently have no products approved for commercial sales and have not generated any revenue from product sales.
Key Factors Affecting Apollomics’ Operating Results We believe that our future performance and success depends to a substantial extent on our product candidate pipeline and the development of our product candidates, each of which is in turn subject to significant risks and challenges, including those discussed in Item 4 and in the section of this Annual Report entitled Item 3.D.
Save as disclosed below, we did not hedge or consider it necessary to hedge any of these risks. B. Liquidity and Ca pital Resources Funding Requirements Since our inception, we have incurred significant operating losses. We expect to incur significant expenses and continuing operating losses for the foreseeable future as we advance the clinical development of our programs.
B. Liquidity and Ca pital Resources Funding Requirements Since our inception, we have incurred significant operating losses. We expect to incur significant expenses and continuing operating losses for the foreseeable future as we advance the clinical development of our programs.
The following table represents our cash and cash equivalents and highly liquid financial assets as of December 31, 2022 and as of December 31, 2023: 114 Table of Contents As of December 31, (Amounts in thousands) 2022 2023 Cash and cash equivalents $ 32,675 $ 32,056 Time deposits with maturity less than twelve months 2,872 — Time deposits with maturity greater than twelve months 4,307 — Financial assets at FVTPL 19,067 5,761 Total $ 58,922 $ 37,817 We may seek to raise any necessary additional capital through a combination of public or private equity offerings, debt financings, collaborations, strategic alliances, licensing arrangements and other marketing and distribution arrangements.
The following table represents our cash and cash equivalents and highly liquid financial assets as of December 31, 2023 and as of December 31, 2024: As of December 31, (Amounts in thousands) 2023 2024 Cash and cash equivalents $ 32,056 $ 9,766 Financial assets at FVTPL 5,761 — Total $ 37,817 $ 9,766 We may seek to raise any necessary additional capital through a combination of public or private equity offerings, debt financings, collaborations, strategic alliances, licensing arrangements and other marketing and distribution arrangements.
The increase of $10.7 million, or 107.5%, was primarily due to a $6.2 million increase in employee share-based compensation mainly from the fair values of the March 2023 grants at the high IPO share price, a $3.9 million increase in third-party service fees related to the business combination, a $2.4 million increase in other administration expenses mainly related to the business combination, and partially offset by a $(1.5) million decrease in employee other compensation and benefits from the resignation of 3 employees replaced by third party consultants. 112 Table of Contents Year Ended December 31, 2021 Compared to Year Ended December 31, 2022 Other Income The following table summarizes the components of our other income for the years ended December 31, 2021 and 2022: Years Ended December 31, 2021 2022 Interest income $ 467 $ 431 Government grants 587 1,016 Total $ 1,054 $ 1,447 Other income was $1.1 million for the year ended December 31, 2021, compared to $1.4 million for the year ended December 31, 2022.
The increase of $10.7 million, or 107.5%, was primarily due to a $6.2 million increase in employee share-based compensation mainly from the fair values of the March 2023 grants at the high IPO share price, a $3.9 million increase in third-party service fees related to the business combination, a $2.4 million increase in other administration expenses mainly related to the business combination, and partially offset by a $(1.5) million decrease in employee other compensation and benefits from the resignation of 3 employees replaced by third party consultants.
Fair Value Change of Convertible Preferred Shares The fair value change of convertible preferred shares for the year ended December 31, 2021 was $(37.4) million, compared to $(189.6) million for the year ended December 31, 2022.
Fair Value Change of Convertible Preferred Shares The fair value change of convertible preferred shares for the year ended December 31, 2023 was $(76.4) million, compared to $0 for the year ended December 31, 2024.
Administrative expenses also include professional fees for legal, patent, consulting, accounting, tax and audit services, travel expenses and facility-related expenses, which include direct depreciation costs and allocated expenses for rent and maintenance of facilities, technology, and other operating costs. We expect that our administrative expenses will increase in the future to support public company expenses and potentially pre-commercial expenses.
Administrative expenses also include professional fees for legal, patent, consulting, accounting, tax and audit services, travel expenses and facility-related expenses, which include direct depreciation costs and allocated expenses for rent and maintenance of facilities, technology, and other operating costs.
We also operate in China with our discovery and development team located in Hangzhou. We also have subsidiaries in Australia (Apollomics (Australia) Pty Ltd, formed in November 2016), Hong Kong (Apollomics (Hong Kong) Limited, formed in June 2019) and China (Zhejiang Crownmab (“Zhejiang Crownmab”) Biotech Co. Ltd. and Zhejiang Crown Bochuang Biopharma Co.
We have wholly-owned subsidiaries in Australia (Apollomics (Australia) Pty Ltd, formed in November 2016), Hong Kong (Apollomics (Hong Kong) Limited, formed in June 2019) and China (Zhejiang Crownmab (“Zhejiang Crownmab”) Biotech Co. Ltd. and Zhejiang Crown Bochuang Biopharma Co. Ltd., formed in May 2018 and May 2020, respectively).
Development costs which do not meet these criteria are expensed when incurred. We assess the progress of each of the research and development projects and determine whether the criteria are met for capitalization. For all periods presented, all the related development costs are expensed when incurred. Intellectual Property Intellectual property rights are important to the success of our business.
Development costs which do not meet these criteria are expensed when incurred. We assess the progress of each of the R&D projects and determine whether the criteria are met for capitalization.
There can be no assurance that management’s attempts to raise additional capital will be successful, and could ultimately result in reassessing the Company’s ability to continue as a going concern. Components of Results of Operations Other Income Other income primarily consists of interest income and government grants. Interest income is primarily derived from our cash and cash equivalents.
There can be no assurance that management’s attempts to raise additional capital will be successful, and could ultimately result in reassessing the Company’s ability to continue as a going concern.
On the lease commencement, we recognized $0.5 million and $0.5 million of right-of-use asset and lease liabilities, respectively. During the year ended December 31, 2023 we did not enter into any new lease agreements. C. Research and Development, Patents and Licenses, etc.
On the lease commencement, we recognized $0.9 million and $0.9 million of right-of-use asset and lease liabilities, respectively. Off-Balance Sheet Arrangements We did not have any off-balance sheet arrangements as of December 31, 2023 or 2024. C. Research and Development, Patents and Licenses, etc.
Our future capital requirements and the adequacy of available funds will depend on many factors, including those set forth in the section titled “ Risk Factors – Risks Related to Our Business .” Cash Flows The following table summarizes our cash flows for the years ended December 31, 2021, 2022 and 2023: Years Ended December 31, (Amounts in thousands) 2021 2022 2023 Net cash used in operating activities $ (43,312 ) $ (42,824 ) $ (43,209 ) Net cash (used in) or provided by investing activities (38,950 ) 29,053 21,365 Net cash (used in) or provided by financing activities (1,643 ) (294 ) 21,225 Net change in cash and cash equivalents $ (83,905 ) $ (14,065 ) $ (619 ) Cash Flows Used in Operating Activities Our cash flows from operating activities are significantly affected by the growth of our business, and are primarily related to research and development, and administrative expenses.
“ Risk Factors—Risks Related to Our Business .” Cash Flows The following table summarizes our cash flows for the years ended December 31, 2022, 2023 and 2024: Years Ended December 31, (Amounts in thousands) 2022 2023 2024 Net cash used in operating activities $ (42,824 ) $ (43,209 ) $ (28,743 ) Net cash provided by investing activities 29,053 21,365 5,983 Net cash (used in) or provided by financing activities (294 ) 21,225 468 Effects of exchange rate changes on cash and cash equivalents — — 2 Net change in cash and cash equivalents $ (14,065 ) $ (619 ) $ (22,290 ) Cash Flows Used in Operating Activities Our cash flows from operating activities are significantly affected by the growth of our business, and are primarily related to R&D, and administrative expenses.
For the years ended December 31, 2022 and 2023, the fair value change of financial assets at fair value through profit or loss was a $323 thousand increase and a $821 thousand increase, respectively Fair Value Change of Convertible Preferred Shares Fair value change of convertible preferred shares consists of non-cash impacts on our profit or loss as a result of the fair value change of the liabilities arising from our convertible preferred shares.
Fair Value Change of Convertible Preferred Shares Fair value change of convertible preferred shares consists of non-cash impacts on our profit or loss as a result of the fair value change of the liabilities arising from the conversion of our convertible preferred shares to common shares for the year ending December 31, 2023.
The duration, costs and timing of clinical trials and development of therapeutic candidates will depend on a variety of factors, including: • the scope, rate of progress, and expense of our ongoing, as well as any additional, clinical trials and other research and development activities; • future clinical trial results; • potential changes in government regulation; and • the timing and receipt of any regulatory approvals.
We cannot determine with certainty the duration and completion costs of the current or future clinical trials of our therapeutic candidates or if, when, or to what extent we will generate revenues from the commercialization and sale of any of our therapeutic candidates for which we or any partner obtain regulatory approval. 88 Table of Contents The duration, costs and timing of clinical trials and development of therapeutic candidates will depend on a variety of factors, including: • the scope, rate of progress, and expense of our ongoing, as well as any additional, clinical trials and other R&D activities; • future clinical trial results; • potential changes in government regulation; and • the timing and receipt of any regulatory approvals.
If we obtain regulatory approval for any of our product candidates, we expect to incur significant expenses related to developing our internal commercialization capability to support product sales, marketing, and distribution. 107 Table of Contents Since our inception, we have incurred significant operating losses.
“ Risk Factors .” We currently have no products approved for commercial sales and have not generated any revenue from product sales. If we obtain regulatory approval for any of our product candidates, we expect to incur significant expenses related to developing our internal commercialization capability to support product sales, marketing, and distribution.
Net cash used in operating activities was $(43.3) million for the year ended December 31, 2021 resulting primarily from a net loss of $(94.8) million, adjusted for non-cash charges of $37.4 million in increased fair value change of our convertible preferred shares, $3.0 million in impairment loss of intangible assets, $681 thousand in depreciation and amortization including depreciation of operating right-of-use of assets, $8.1 million in share-based payments, $(467) thousand in interest income, and $2.6 million in working capital adjustments.
Net cash used in operating activities was $(28.7) million for the year ended December 31, 2024, resulting primarily from a net loss of $(53.9) million, adjusted for non-cash charges of $0.4 million in depreciation and amortization including depreciation of operating right-of-use of assets, $13.0 million in impairment loss on intangible assets, $10.9 million in share-based payments, partially offset by $(1.0) million in working capital adjustments.
The increase of $0.4 million, or 37.3%, was mainly from an increase of $0.4 million subsidies received from the Australian government specifically for supporting the research and development activities carried out in Australia offset by a $(36) thousand decrease in interest income.
The increase of $0.3 million, or 22.4%, was mainly driven by a $0.5 million write off for a China license liability and $0.2 million in other individually immaterial fluctuations, which was partially offset by a decrease of $(0.2) million in subsidies received from the Australian government specifically for supporting the research and development activities carried out in Australia and a decrease of $(0.3) million in interest income due to lower cash and cash equivalent balances.
Other Gains and Losses The following table summarizes the component of our other gains and losses for the year ended December 31, 2021 and 2022: Years ended December 31, Change 2021 2022 $ % Exchange loss, net $ 36 $ (829 ) $ (865 ) >100% Other gains and losses was a gain of $36 thousand for the year ended December 31, 2021, compared to a loss of $(829) thousand for the year ended December 31, 2022.
Other Gains and Losses The following table summarizes the component of our other gains and losses for the years ended December 31, 2023 and 2024: Years ended December 31, Change 2023 2024 $ % Exchange loss, net $ 1,191 $ 145 $ (1,046 ) (87.8 )% Other gains and losses reflects a gain of $1.2 million for the year ended December 31, 2023, compared to a gain of $0.1 million for the year ended December 31, 2024.
If we raise additional capital through debt financing, we may be subject to covenants limiting or restricting our ability to take specific actions, such as incurring additional debt, making capital expenditures, or declaring dividends.
If we raise additional capital through debt financing, we may be subject to covenants limiting or restricting our ability to take specific actions, such as incurring additional debt, making capital expenditures, or declaring dividends. Our future capital requirements and the adequacy of available funds will depend on many factors, including those set forth in the section titled Item 3.D.
We do not allocate our R&D employee compensation and benefits, nor our R&D employee share- based compensation into our product lines.
We manage our R&D third-party service fees and our contractor expenses by product, which is shown in the table above. We do not allocate our R&D employee compensation and benefits, nor our R&D employee share- based compensation into our product lines.
Other Expenses Our other expenses amounted to $4.5 million, $6.6 million and $46.0 million for the years ended December 31, 2021, 2022 and 2023, respectively.
Other Expenses Our other expenses amounted to $6.6 million, $46.0 million and $0.1 million for the years ended December 31, 2022, 2023 and 2024, respectively. In 2022 and 2023 other expenses primarily included professional fees incurred by us in relation to the business combination transaction.
The increase of $(865) thousand, or >100%, was mainly from the exchange loss of RMB denominated time deposits with original maturity over three months held by one of our PRC subsidiaries.
The decrease of $(1.0) million, or 87.8%, was primarily from the exchange gain of $1.6 million of RMB denominated time deposits with original maturity over three months held by one of our PRC subsidiaries, and the exchange gain of $0.5 million in Australian dollars in 2023.
Please refer to notes 4 and 5 to our audited consolidated financial statements included elsewhere in this Annual Report for more details about our material accounting policies and critical judgment and key estimates. 117 Table of Contents Emerging Growth Company As defined in Section 102(b)(1) of the JOBS Act (the “JOBS Act”), we are an emerging growth company (“EGC”).
Please refer to note 6 to our audited consolidated financial statements included elsewhere in this Annual Report for more details about our material accounting policies and critical judgment and key estimates.
Cash Flows From/Used in Financing Activities Net cash used in financing activities was $1.6 million for the year ended December 31, 2021 resulting primarily from $1.2 million issuance costs paid, the repayment of our lease liabilities for $528 thousand, and $83 thousand interest paid, offset by the proceeds on issuance of our Class A Ordinary Shares upon exercise of share options for $(141) thousand.
Net cash provided by financing activities was $0.5 million for the year ended December 31, 2024 resulting primarily from the proceeds from the PIPE financing in May 2024, net of transaction costs for $5.0 million and $0.7 million in proceeds from bank loans which was partially offset by the repayment of our bank loans of $(4.9) million, repayment of lease liabilities of $(0.2) million, and interest paid of $(0.2) million.
As of December 31, 2023, we owned a total of 30 granted or issued patents and 49 pending patent applications, including two pending PCT applications, relating to our drug candidates and technologies. D. Tre nd Information Macroeconomic Factors Global economic challenges have contributed to rising inflation, significant increases in fuel costs, supply-chain disruptions, and adverse labor market conditions.
As of December 31, 2024, we owned a total of 65 granted or issued patents and 24 pending patent applications, including one pending PCT applications, relating to our drug candidates and technologies. D.
We were originally formed as CB Therapeutics Inc. as a result of a spin-off of Crown Bioscience International, which was completed on December 31, 2015. As a result, we became the owner of certain patent and intellectual property rights relating to some of our product candidates.
Since our founding in 2015, we have built a pipeline focused on oncology, of which three product candidates remain in active clinical stage development. Our leading product candidate, vebreltinib, has shown initial promising clinical results. We were originally formed as CB Therapeutics Inc. as a result of a spin-off of Crown Bioscience International, which was completed on December 31, 2015.
Cash Flows From/Used in Investing Activities Net cash used in investing activities was $39.0 million for the year ended December 31, 2021 resulting primarily from the placement of time deposits with original maturity of three months for $103.8 million, additions of intangible assets for $7.5 million, additions of plant and equipment for $50 thousand and $25 thousand payment of rental deposits, offset by the proceeds from redemption of our time deposits with original maturity over three months for $71.9 million and interest received on such redemptions for $467 thousand.
Net cash provided by investing activities was $6.0 million for the year ended December 31, 2024 resulting primarily from the proceeds from disposal of our financial assets held at fair value for $5.8 million, and interest received on such financial assets for $0.2 million.
Administrative Expenses The following table summarizes the components of our administrative expenses for the years ended December 31, 2021 and 2022: Years Ended December 31, Change (Amounts in thousands, except percentages) 2021 2022 $ % Administrative Employee Compensations and Benefits $ 5,695 $ 5,028 $ (667 ) (11.7 )% Administrative Employee Share Based Compensation 5,385 602 (4,783 ) (88.8 )% Administrative Third-Party Service Fees 1,928 1,536 (392 ) (20.3 )% Operations 670 524 (146 ) (21.8 )% Sales and Marketing Expenses 64 37 (27 ) (42.2 )% Travel Expenses 178 203 25 14.0 % Facilities 375 415 40 10.7 % Depreciation and amortization 689 781 92 13.4 % Others 307 821 514 167.4 % Total $ 15,291 $ 9,947 $ (5,344 ) (34.9 )% Administrative expenses were $15.3 million for the year ended December 31, 2021, compared to $9.9 million for the year ended December 31, 2022.
Administrative Expenses The following table summarizes the components of our administrative expenses for the years ended December 31, 2023 and 2024: Years ended December 31, Change (Amounts in thousands, except percentages) 2023 2024 $ % Administrative Employee Other Compensation and Benefits $ 3,480 $ 3,581 $ 101 2.9 % Administrative Employee Share-Based Compensation 6,810 6,666 (144 ) (2.1 )% Administrative Third-Party Service Fees 5,389 5,088 (301 ) (5.6 )% Operations 452 435 (17 ) (3.8 )% Sales and Marketing Expenses 77 16 (61 ) (79.2 )% Travel Expenses 261 101 (160 ) (61.3 )% Facilities 251 133 (118 ) (47.0 )% Depreciation and amortization 694 362 (332 ) (47.8 )% Others 3,227 1,386 (1,841 ) (57.0 )% Total $ 20,641 $ 17,768 $ (2,873 ) (13.9 )% Administrative expenses were $20.6 million for the year ended December 31, 2023, compared to $17.8 million for the year ended December 31, 2024.
Research and Development Expenses The following table summarizes the components of our research and development expenses for the years ended December 31, 2021 and 2022: Years Ended December 31, Change (Amounts in thousands, except percentages) 2021 2022 $ % APL-101 $ 16,274 $ 16,767 $ 493 3.0 % APL-102 689 385 (304 ) (44.1 )% APL-106 3,050 3,014 (36 ) (1.2 )% APL-121 157 93 (64 ) (40.8 )% APL-122 and other 457 717 260 56.9 % APL-501 1,254 1,600 346 27.6 % Discovery & other 1,342 975 (367 ) (27.3 )% R&D Third-Party Service Fees and Contractor Expenses: $ 23,223 $ 23,551 $ 328 1.4 % R&D Employee Other Compensation and Benefits 9,607 9,532 (75 ) (0.8 )% R&D Employee Share-Based Compensation 2,738 2,374 (364 ) (13.3 )% Total Research and Development Expenses $ 35,568 $ 35,457 $ (111 ) (0.3 )% Research and development expenses for the year ended December 31, 2021 was $35.6 million, compared to $35.5 million for the year ended December 31, 2022.
The decrease of $76.4 million, or 100%, is due to no preferred shares outstanding as of March 29, 2023 as all were converted to common shares. 90 Table of Contents Research and Development Expenses The following table summarizes the components of our R&D expenses for the years ended December 31, 2023 and 2024: Year Ended December 31, Change (Amounts in thousands, except percentages) 2023 2024 $ % APL-101 $ 16,234 $ 10,332 $ (5,902 ) (36.4 )% APL-102 144 625 481 >100% APL-106 2,621 2,744 123 4.7 % APL-122 274 177 (97 ) (35.4 )% APL-501 1,669 735 (934 ) (56.0 )% Discovery & other — 644 644 100.0 % R&D Third-Party Service Fees and Contractor Expenses: $ 20,942 $ 15,257 $ (5,685 ) (27.1 )% R&D Employee Other Compensation and Benefits 7,376 5,049 (2,327 ) (31.5 )% R&D Employee Share-Based Compensation 5,875 4,260 (1,615 ) (27.5 )% Total Research and Development Expenses $ 34,193 $ 24,566 $ (9,627 ) (28.2 )% Research and development expenses for the year ended December 31, 2023 were $34.2 million, compared to $24.6 million for the year ended December 31, 2024.
For more information relating to the series of transactions resulting in our acquisition of these patent rights, please see the section of this Annual Report entitled “ Intellectual Property Assignment .” Our primary business is conducted at our U.S. headquarter with our global drug development team located in the San Francisco Bay Area.
Our primary business is conducted by our global drug development team at our U.S. headquarters located in the San Francisco Bay Area. We also operate in China with our development team located in Hangzhou.
For example, the war in Ukraine has had a global impact on the supply and price of fuel and has contributed to increased inflation around the world. COVID-19 The COVID-19 pandemic has impacted companies around the world, and as its trajectory remains highly uncertain, we cannot predict the duration and severity of the outbreak and its containment measures.
Tre nd Information Macroeconomic Factors Global economic challenges have contributed to rising inflation, significant increases in fuel costs, supply-chain disruptions, adverse labor market conditions, and increased difficulty with raising capital for unprofitable companies. For example, the war in Ukraine has had a global impact on the supply and price of fuel and has contributed to increased inflation around the world.
The increase of $(152.2) million, or >100%, is primarily due to the increase in the equity value of the Company as the probability of the IPO increased.
The decrease of $113.2 million, or 60%, is due to the increase in the fair value of the convertible preferred shares upon the completion of the business combination.
Removed
Since our founding in 2015, we have built a pipeline of nine product candidates across 11 programs that focus on oncology, of which six product candidates are clinical stage. Our two leading product candidates, vebreltinib (APL-101) and uproleselan (APL-106), have shown promising initial clinical results and are in registration trials.
Added
As a result, we became the owner of certain patent and intellectual property rights relating to some of our product candidates. For more information relating to the series of transactions resulting in our acquisition of these patent rights, please see “— Intellectual Property Assignment ”, above under Item 4.B.
Removed
Government grants consist of unconditional subsidies received from the Australian and U.S. governments to support our research and development activities carried out by us in Australia and in the United States. Other Gains and Losses Other gains and losses primarily consist of foreign exchange gains and losses as a result of foreign exchange rate fluctuation.
Added
In connection with the closing of the Business Combination, Apollomics became a publicly traded company on Nasdaq.
Removed
Our foreign exchange losses amounted to a $(829) thousand loss and a $1.2 million gain for the years ended December 31, 2022 and 2023, respectively.
Added
Since our inception, we have incurred significant operating losses.
Removed
We cannot determine with certainty the duration and completion costs of the current or future clinical trials of our therapeutic candidates or if, when, or to what extent we will generate revenues from the commercialization and sale of any of our therapeutic candidates for which we or any partner obtain regulatory approval.
Added
In July 2024, we implemented additional expense reductions, including a more narrow development focus for vebreltinib, other pipeline cuts, as well as reductions in executive and non-executive employees.
Removed
In 2021 other expenses primarily include fees incurred by us in relation to certain professional services for our endeavor to list on the mainboard of The Stock Exchange of Hong Kong Limited in a global offering (“Hong Kong Offering”) in February 2021 that ultimately did not occur.
Added
Components of Results of Operations Other Income Other income primarily includes income from a licensee whose negotiation period was no longer valid and income for a liability that was extinguished in the current year. Other income also includes interest income primarily derived from our cash and cash equivalents.
Removed
The decrease of $(0.1) million (or 0.3%) is primarily due to $(364) thousand decrease in share-based compensation, $75 thousand decrease in employee other compensation and benefits, offset by a $328 thousand increase in third party service fees as distributed amongst our various products.
Added
For the years ended December 31, 2023 and 2024, the fair value change of financial assets at fair value through profit or loss was a $0.8 million increase and a $0.2 million increase, respectively.
Removed
Decreased employee share-based compensation was primarily attributable to the forfeiture of share-based compensation of 12 R&D employees who resigned in 2021, offset by the new grants for eight new R&D employees in 2022. 113 Table of Contents We manage our R&D third-party service fees and our contractor expenses by product, which is shown in the table above.
Added
We expect that our administrative expenses will decrease substantially in the future in line with our strategic shift, as we decrease our administrative personnel, including the departure of two of our executive officers, and overall reduction of external expenses.

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Item 6. [Reserved]

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

35 edited+5 added−5 removed59 unchanged
Biggest changeGuo-Liang Yu is the founding president of the Chinese Biopharmaceutical Association USA and Chairman of the Bayhelix Group. Dr. Yu earned a B.S. in Biochemistry from Fudan University, a Ph.D. in Molecular Biology from University of California, Berkeley and was a Post- Doctoral Fellow at Harvard Medical School. Dr.
Biggest changeYu earned a B.S. in Biochemistry from Fudan University, a Ph.D. in Molecular Biology from University of California, Berkeley and was a Post-Doctoral Fellow at Harvard Medical School. Dr. Matthew Plunkett serves as our Chief Financial Officer and Principal Financial Officer. Since March 2024, Dr. Plunkett has served as the Chief Financial Officer of Apollomics.
The functions and powers of our Board include, among others: • conducting and managing the business of our company; • representing our company in contracts and deals; • appointing attorneys for our company; • selecting senior management such as managing directors and executive directors; • providing employee benefits and pension; • convening shareholders’ annual general meetings and reporting its work to shareholders at such meetings; • declaring dividends and distributions; • exercising the borrowing powers of our company and mortgaging the property of our company; • approving the transfer of shares of our company, including the registering of such shares in our register of members; and • exercising any other powers conferred by the shareholders or under our memorandum and articles of association, as amended and restated from time to time.
The functions and powers of our Board include, among others: • conducting and managing the business of our company; 100 Table of Contents • representing our company in contracts and deals; • appointing attorneys for our company; • selecting senior management such as managing directors and executive directors; • providing employee benefits and pension; • convening shareholders’ annual general meetings and reporting its work to shareholders at such meetings; • declaring dividends and distributions; • exercising the borrowing powers of our company and mortgaging the property of our company; • approving the transfer of shares of our company, including the registering of such shares in our register of members; and • exercising any other powers conferred by the shareholders or under our memorandum and articles of association, as amended and restated from time to time.
The audit committee is responsible for, among other things: • appointing our independent registered public accounting firm and pre-approving all auditing and non-auditing services permitted to be performed by our independent registered public accounting firm; • reviewing with our independent registered public accounting firm any audit problems or difficulties and management’s response; • reviewing and approving proposed related party transactions; • discussing the annual audited financial statements with management and our independent registered public accounting firm; and 123 Table of Contents • reviewing the adequacy and effectiveness of our internal controls, any actions taken in light of any material control deficiencies and any steps taken to monitor and control major financial risk exposures.
The audit committee is responsible for, among other things: • appointing our independent registered public accounting firm and pre-approving all auditing and non-auditing services permitted to be performed by our independent registered public accounting firm; • reviewing with our independent registered public accounting firm any audit problems or difficulties and management’s response; • reviewing and approving proposed related party transactions; • discussing the annual audited financial statements with management and our independent registered public accounting firm; and • reviewing the adequacy and effectiveness of our internal controls, any actions taken in light of any material control deficiencies and any steps taken to monitor and control major financial risk exposures.
Unissued shares subject to awards that expire or are cancelled, underlying shares reacquired by us, and underlying shares withheld in payment of the purchase price or exercise price of an award or in satisfaction of withholding taxes will again become available for issuance under the 2016 Plan; however, they will not again become available for issuance under the 2023 Incentive Plan. 2023 Share Incentive Plan We use equity-based awards to provide our employees with an incentive for remaining in our service and aligning their interests with those of our equity holders.
Unissued shares subject to awards that expire or are cancelled, underlying shares reacquired by us, and underlying shares withheld in payment of the purchase price or exercise price of an award or in satisfaction of withholding taxes will 98 Table of Contents again become available for issuance under the 2016 Plan; however, they will not again become available for issuance under the 2023 Incentive Plan. 2023 Share Incentive Plan We use equity-based awards to provide our employees with an incentive for remaining in our service and aligning their interests with those of our equity holders.
In general and notwithstanding the foregoing, because we are a foreign private issuer, our compensation committee is not subject to additional Nasdaq corporate governance requirements applicable to listed U.S. companies, including the requirements to have a minimum of two members and to affirmatively determine that at least two members are “independent.” Our compensation committee assists the Board in reviewing and approving the compensation structure, including all forms of compensation, relating to our directors and executive officers.
In general and notwithstanding the foregoing, because we are a foreign private issuer, our compensation committee is not subject to additional Nasdaq corporate governance requirements applicable to listed U.S. companies, including the 101 Table of Contents requirements to have a minimum of two members and to affirmatively determine that at least two members are “independent.” Our compensation committee assists the Board in reviewing and approving the compensation structure, including all forms of compensation, relating to our directors and executive officers.
The term of a share option or SAR may not be longer than 10 years from grant (or five years in the case of ISOs granted to certain significant shareholders). Restricted Shares . Restricted shares are an award of nontransferable Class A Ordinary Shares that are subject to certain vesting conditions and other restrictions. RSUs .
The term of a share option or SAR may not be longer than 10 years from grant (or five years in the case of ISOs granted to certain significant shareholders). Restricted Shares . Restricted shares are an award of nontransferable Class A Ordinary Shares that are subject to certain vesting conditions and other restrictions. 99 Table of Contents RSUs .
Hayes was an audit partner at Deloitte (China). Ms. Hayes is a certified public accountant in the United States (California) and in China. Ms. Hayes received her bachelor’s degree in international finance from the University of International Business and Economics in Beijing and received an MBA from Cheung Kong Graduate School of Business in Shanghai. Glenn S.
Hayes was an audit partner at Deloitte (China). Ms. Hayes is a certified public accountant in the United States (California) and in China. Ms. Hayes received her bachelor’s degree in international finance from the University of International Business and Economics in Beijing and received an MBA from Cheung Kong Graduate School of Business in Shanghai. Dr.
Chen has more than 20 years of experience in formulating and implementing basic research and preclinical development strategies for small molecules, biologics and cell therapy and is also experienced in advancing drug candidates from discovery to nomination for IND and development. Dr.
Chen has more than 20 years of experience in formulating and implementing basic research and preclinical development strategies for small molecules, biologics and cell therapy and is also experienced in advancing drug candidates from discovery to nomination for IND and development. 97 Table of Contents Dr.
Our company has the right to seek damages if a duty owed by our directors is breached. In limited exceptional circumstances, a shareholder may have the right to seek damages in our name if a duty owed by our directors is breached.
In limited exceptional circumstances, a shareholder may have the right to seek damages in our name if a duty owed by our directors is breached.
Item 6. Dir ectors, Senior Management and Employees A. Dire ctors and Senior Management Executive Officers and Directors The following table provides information about our directors and executive officers as of March 28, 2024. The address for each of the directors and executive officers is 989 E. Hillsdale Boulevard, Suite 220, Foster City, CA 94404. Name Age Position(s) Dr.
Item 6. Dir ectors, Senior Management and Employees A. Dire ctors and Senior Management Executive Officers and Directors The following table provides information about our directors and executive officers as of March 27, 2025. The address for each of the directors and executive officers is 989 E. Hillsdale Boulevard, Suite 220, Foster City, CA 94404. Name Age Position(s) Dr.
SARs entitle their holder, upon exercise, to receive from us an amount in cash or shares equal to the appreciation of the shares subject to the 121 Table of Contents award between the grant date and the exercise date.
SARs entitle their holder, upon exercise, to receive from us an amount in cash or shares equal to the appreciation of the shares subject to the award between the grant date and the exercise date.
Our amended and restated memorandum and articles of association were adopted upon completion of the Business Combination and provide for indemnification of our officers and directors to the maximum extent permitted by law, including for any liability incurred in their capacities as such, except through their own actual fraud, willful default or willful neglect.
Our amended and restated memorandum and articles of association were adopted upon completion of the Business Combination and provide for indemnification of our officers and directors to the maximum extent permitted by law, including for any liability incurred in their capacities as such, except through their fraud or dishonesty.
Nominating and Corporate Governance Committee Our nominating and corporate governance committee consists of Dr. Hong-Jung (Moses) Chen, Glenn S. Vraniak and Jonathan Wang, with Dr. Hong-Jung (Moses) Chen serving as the chair.
Nominating and Corporate Governance Committee Our nominating and corporate governance committee consists of Dr. Hong-Jung (Moses) Chen, Dr. (Bob) Lin and Glenn S. Vraniak, with Dr. Hong-Jung (Moses) Chen serving as the chair.
Com pensation of Directors and Executive Officers Apollomics’ Compensation of Officers and Directors The aggregate compensation paid and share-based compensation and other payments expensed by us and our subsidiaries to our directors and executive officers with respect to the year ended December 31, 2023 was $13,552,147.
Com pensation of Directors and Executive Officers Apollomics’ Compensation of Officers and Directors The aggregate compensation paid and share-based compensation and other payments expensed by us and our subsidiaries to our directors and executive officers with respect to the year ended December 31, 2024 was $14,960,523.
No further awards will be made under the 2016 Plan; however, awards outstanding under the 2016 Plan will continue to be governed by their existing terms. 120 Table of Contents As of December 31, 2022, we had reserved 337,225,866 of our Class A Ordinary Shares for issuance under the 2016 Plan, which may be issued in the form of share options, share appreciation rights, restricted share unit awards, or other share-based awards pursuant to the terms of the 2016 Plan.
As of December 31, 2022, we had reserved 337,225,866 of our Class A Ordinary Shares for issuance under the 2016 Plan, which may be issued in the form of share options, share appreciation rights, restricted share unit awards, or other share-based awards pursuant to the terms of the 2016 Plan.
Plunkett served as Chief Financial and Business Officer of Medeor Therapeutics from September 2017 and November 2018. Prior to that, he served as Chief Business Officer of CTI BioPharma (Nasdaq: CTIC), a publicly traded biopharmaceutical company, from December 2015 to August 2017 and as Executive Vice President Corporate Development from September 2012 until December 2015.
Prior to that, he served as Chief Business Officer of CTI BioPharma (Nasdaq: CTIC), a publicly traded biopharmaceutical company, from December 2015 to August 2017 and as Executive Vice President Corporate Development from September 2012 until December 2015. From November 2011 to August 2012, he served as the Chief Financial Officer of the California Institute for Regenerative Medicine. Dr.
Eligibility . Certain of our employees, directors, officers, advisors or consultants, or our affiliates, are eligible to participate in the 2023 Incentive Plan. 63 employees, consultants, advisors and service providers and all non-executive officer directors are eligible to participate in the 2023 Incentive Plan. Number of Shares Authorized .
Eligibility . Certain of our employees, directors, officers, advisors or consultants, or our affiliates, are eligible to participate in the 2023 Incentive Plan. Number of Shares Authorized .
As of December 31, 2023, we had 45 full-time employees. 124 Table of Contents Due to the high technical requirements of our industry, our workforce comprises many high caliber scientists and experts with experience in the pharmaceutical and biotechnology industries. Most of our workforce is highly-educated, with many employees holding advanced degrees from overseas institutions.
Due to the high technical requirements of our industry, our workforce comprises many high caliber scientists and experts with experience in the pharmaceutical and biotechnology industries. Most of our workforce is highly educated, with many employees holding advanced degrees from overseas institutions.
From January 2021 to September 2021, he served as Chief Financial Officer at Imago Biosciences (Nasdaq: IMGO). Dr. Plunkett served as Chief Financial Officer of Nkarta Therapeutics (Nasdaq: NKTX), from September 2019 until October 2020 and as Senior Vice President and Chief Financial Officer from November 2018 to September 2019. Previously, Dr.
Plunkett served as Chief Financial Officer of Nkarta Therapeutics (Nasdaq: NKTX), from September 2019 until October 2020 and as Senior Vice President and Chief Financial Officer from November 2018 to September 2019. Previously, Dr. Plunkett served as Chief Financial and Business Officer of Medeor Therapeutics from September 2017 to November 2018.
Vraniak serves as a member of our board of directors. Since May 2022, Mr. Vraniak has served as the Chief Financial Officer of Inversago Pharma Inc. From November 2021 to April 2022, Mr. Vraniak served as Chief Financial Officer of the autonomous automotive technology division of Valeo, a Paris-based public company focused on the automotive sector.
Vraniak has served as the Founder and Managing Partner of Preceptis Capital. From May 2022 to July 2024, Mr. Vraniak served as the Chief Financial Officer of Inversago Pharma Inc. From November 2021 to April 2022, Mr. Vraniak served as Chief Financial Officer of the autonomous automotive technology division of Valeo, a Paris-based public company focused on the automotive sector.
E mployees We believe that our corporate culture and our relationship with our employees contribute to our success. Our employees are continuously innovating, and our structure rewards productivity.
E mployees We believe that our corporate culture and our relationship with our employees contribute to our success. Our employees are continuously innovating, and our structure rewards productivity. As of December 31, 2024, we had 13 full-time employees.
In fulfilling their duty of care to us, our directors must ensure compliance with our memorandum and articles 122 Table of Contents of association, as amended and restated from time to time, and the class rights vested thereunder in the holders of the shares.
In fulfilling their duty of care to us, our directors must ensure compliance with our memorandum and articles of association, as amended and restated from time to time, and the class rights vested thereunder in the holders of the shares. Our company has the right to seek damages if a duty owed by our directors is breached.
Sanjeev Redkar 55 President and Director Dr. Guo-Liang Yu 61 Chairman of the Board of Directors and Chief Executive Officer Dr. Matthew Plunkett 52 Chief Financial Officer and Principal Financial Officer Dr. Kin-Hung Peony Yu 61 Chief Medical Officer Dr. Kenneth C. Carter 64 Director Dr. Hong-Jung (Moses) Chen 64 Director Wendy Hayes 54 Director Glenn S.
Guo-Liang Yu 62 Chairman of the Board of Directors and Chief Executive Officer Dr. Matthew Plunkett 53 Chief Financial Officer and Principal Financial Officer Dr. Kenneth C. Carter 65 Director Dr. Hong-Jung (Moses) Chen 65 Director Wendy Hayes 55 Director Dr. Robert (Bob) Lin 61 Director Dr. Sanjeev Redkar 56 Director Glenn S. Vraniak 62 Director Executive Officers Dr.
Ltd. since March 2023, and has been a supervisor of ReVasgen Inc. since October 2014. Previously, from October 2014 to January 2017, Dr. Chen worked as Vice President and Acting Chief Operating Officer for SyneuRx International Corp. in Taiwan, where he was responsible for supervising the company’s daily operation and personally interacting with VC representatives and private investors. Dr.
Chen worked as Vice President and Acting Chief Operating Officer for SyneuRx International Corp. in Taiwan, where he was responsible for supervising the company’s daily operation and personally interacting with VC representatives and private investors. Dr.
Redkar earned a B.S. in Chemical Engineering from the Indian Institute of Technology, a M.S. in Chemical Engineering from the University of Colorado, Boulder, a Ph.D. in Chemical Engineering from the University of Colorado, Boulder and an MBA from St. Mary’s College of California. Dr. Guo-Liang Yu serves as our Chairman and Chief Executive Officer. Since January 2016, Dr.
Redkar earned a B.S. in Chemical Engineering from the Indian Institute of Technology, a M.S. in Chemical Engineering from the University of Colorado, Boulder, a Ph.D. in Chemical Engineering from the University of Colorado, Boulder and an MBA from St. Mary’s College of California. Glenn S. Vraniak serves as a member of our board of directors. Since August 2024, Mr.
Vraniak 61 Director Dr. Jonathan Wang 56 Director Executive Officers Dr. Sanjeev Redkar serves as our President and Director. Since January 2016, Dr. Redkar has served as the President of Apollomics, which he co-founded. From September 2011 to January 2016, Dr. Redkar held various roles at Astex Pharmaceuticals, Inc.
Dr. Sanjeev Redkar serves as a member of our board of directors. From January 2016 through July 2024, Dr. Redkar served as the President of Apollomics, which he co-founded. From September 2011 to January 2016, Dr. Redkar held various roles at Astex Pharmaceuticals, Inc.
Guo-Liang Yu has served as the Chairman and Chief Executive Officer of Apollomics, which he co-founded. From 2013 to 2018, Dr. Guo-Liang Yu served as Executive Chairman at Crown Bioscience Inc. Dr. Guo-Liang Yu has co-founded several startup companies in biotech and healthcare, including Epitomics Inc. and Immune-Onc Therapeutics, Inc. in Palo Alto, California. Dr.
Guo-Liang Yu serves as our Chairman and Chief Executive Officer. Since January 2016, Dr. Guo-Liang Yu has served as the Chairman and Chief Executive Officer of Apollomics, which he co-founded. From 2013 to 2018, Dr. Guo-Liang Yu served as Executive Chairman at Crown Bioscience Inc. Dr.
Yu earned an M.D. from the University of California, Davis School of Medicine. 119 Table of Contents Directors Dr. Kenneth C. Carter serves as a member of our board of directors. Since 2020, Dr. Carter has served as the Global Head of Corporate Development and President of US Operations at Innoforce, Inc. Dr.
Plunkett holds a B.S. in Chemistry from Harvey Mudd College and a Ph.D. in Chemistry from University of California, Berkeley. Directors Dr. Kenneth C. Carter serves as a member of our board of directors. Since 2020, Dr. Carter has served as the Global Head of Corporate Development and President of U.S. Operations at Innoforce, Inc. Dr.
Chen has been Managing Director of Maxpro Ventures LTD since May 2018, which is an investment firm focused on breakthrough biomedical technology companies, and served as Chairman of the Board of Directors and Chief Executive Officer of Maxpro. Dr. Chen is also an ad hoc reviewer of Stem Cells Translational Medicine, and has served as director of Uneuron Biomedical Co.
Chen was Managing Director of Maxpro Ventures LTD from May 2018 to February 2024, which is an investment firm focused on breakthrough biomedical technology companies, and served as Chairman of the Board of Directors and Chief Executive Officer of Maxpro Capital Acquisition Corp. from June 2021 to March 2023. Dr.
Matthew Plunkett serves as our Chief Financial Officer and Principal Financial Officer. Since March 2024, Dr. Plunkett has served as the Chief Financial Officer of Apollomics. Prior to joining Apollomics, he was Chief Financial Officer at Aeovian Pharmaceuticals from March 2022 to February 2024.
Prior to joining Apollomics, he was Chief Financial Officer at Aeovian Pharmaceuticals from March 2022 to February 2024. From January 2021 to September 2021, he served as Chief Financial Officer at Imago Biosciences (Nasdaq: IMGO). Dr.
“ Major Shareholders and Related Party Transactions—Major Shareholders .” For information as to our equity incentive plans, see Item 6.B. “ Director, Senior Management and Employees—Compensation—Share Option Plans .”
“ Major Shareholders and Related Party Transactions—Major Shareholders .” For information as to our equity incentive plans, see Item 6.B. “ Directors, Senior Management and Employees—Compensation of Directors and Executive Officers .” 102 Table of Contents F. Disclosure of a Registrant’s Action to Recover Erroneously Awarded Compensation Not applicable.
From November 2011 to August 2012, he served as the Chief Financial Officer of the California Institute for Regenerative Medicine. Dr. Plunkett served as the Vice President and Chief Financial Officer of iPierian, Inc. from July 2009 to April 2011. From December 2000 to July 2009, Dr. Plunkett held positions at Oppenheimer & Co.
Plunkett served as the Vice President and Chief Financial Officer of iPierian, Inc. from July 2009 to April 2011. From December 2000 to July 2009, Dr. Plunkett held positions at Oppenheimer & Co. Inc. and its U.S. predecessor, CIBC World Markets Corp., including as Managing Director and Head of West Coast Biotechnology. Dr.
Hayes previously served on the board of TuSimple (Nasdaq: TSP) from December 2022 to December 2023, and Gracell Biotechnologies Inc. (NASDAQ: GRCL) from January 2021 to February 2023. From May 2013 to September 2018, Ms. Hayes served as the Inspections Leader at the Public Company Accounting Oversight Board in the United States. Prior to that, Ms.
Hayes serves on the boards of directors of other public companies, including iHuman Inc. (NYSE: IH) since October 2020, and Burning Rock Biotech Limited (Nasdaq: BNR) since June 2020. From May 2013 to September 2018, Ms. Hayes served as the Inspections Leader at the Public Company Accounting Oversight Board in the United States. Prior to that, Ms.
Vraniak earned an electrical engineering technology degree and a managerial MBA from the Rutgers University Center for Management Development. Dr. Jonathan Wang has served as a member of Apollomics’ board of directors since 2016. Dr. Wang has served as the Chairman and Chief Executive Officer of Inmagene Biopharmaceuticals since July 2019. From July 2007 to July 2019, Dr.
Vraniak earned an electrical engineering technology degree and a managerial MBA from the Rutgers University Center for Management Development. B.
The 2016 Plan has not been amended since its adoption in July 2016.
The 2016 Plan has not been amended since its adoption in July 2016. No further awards will be made under the 2016 Plan; however, awards outstanding under the 2016 Plan will continue to be governed by their existing terms.
Removed
Inc. and its U.S. predecessor, CIBC World Markets Corp., including as Managing Director and Head of West Coast Biotechnology. Dr. Plunkett holds a B.S. in Chemistry from Harvey Mudd College and a Ph.D. in Chemistry from University of California, Berkeley. Dr. Kin-Hung Peony Yu serves as our Chief Medical Officer. Dr.
Added
Guo-Liang Yu has co-founded several startup companies in biotech and healthcare, including Epitomics Inc. and Immune-Onc Therapeutics, Inc. in Palo Alto, California. Dr. Guo-Liang Yu is the founding president of the Chinese Biopharmaceutical Association USA and Chairman of the Bayhelix Group. Dr.
Removed
Yu has served as the Chief Medical Officer of Apollomics since March 2021. From 2008 to 2021, Dr. Yu served in various roles at FibroGen, Inc. (Nasdaq: FGEN), including as Chief Medical Officer and Senior Vice President from April 2016 to December 2020. From 2006 to 2008, Dr.
Added
Chen is also an ad hoc reviewer of Stem Cells Translational Medicine, and has served as director of Uneuron Biomedical Co. Ltd. since March 2023, and has been a supervisor of ReVasgen Inc. since October 2014. Previously, from October 2014 to January 2017, Dr.
Removed
Yu served as Vice President of Clinical Development for Anesiva (Nasdaq: ANSV) and served as the Director, Clinical Development of ALZA Corporation from 2004 to 2006. Since January 2021, Dr. Yu has served on the board of directors of STAAR Surgical (Nasdaq: STAA). Dr.
Added
Robert (Bob) Lin serves as a member of our board of directors. Robert Lin, MD, PhD, is a physician and researcher who has conducted dozens of multinational clinical trials and is experienced in genomics and proteomics.
Removed
Hayes serves on the boards of directors of multiple public companies, including SharkNinja, Inc. (NYSE: SN) since July 2023, SciClone Pharmaceuticals (Holdings) Ltd (HK: 6600) since March 2021, iHuman Inc. (NYSE: IH) since October 2020, Burning Rock Biotech Limited (NASDAQ: BNR) since June 2020 and Tuanche Limited (NASDAQ: TC) since November 2018. Ms.
Added
His extensive background in clinical medicine and basic research enables him to delve into the fundamentals of new innovations and provide thorough assessments of their clinical applications. Dr. Lin has evaluated hundreds of biotech and healthcare investments and has been involved in dozens of multi-million-dollar biotech deals. He serves as a trusted advisor on multiple committees in the Asia-Pacific region.
Removed
Wang served as a Partner at OrbiMed and co- founded OrbiMed Asia. In 2000, Dr. Wang co-founded BayHelix. Dr. Wang earned his Master of Arts, Master of Philosophy and Ph.D. from Columbia University. Dr. Wang also earned an MBA from Stanford University. B.
Added
Dr. Lin has served as the vice director of the Internal Medicine Department at a tertiary medical center in Taiwan and as a member of the censorship committee of the AAHRPP-certified Institutional Review Board. He earned an M.D. and a Ph.D. degree from National Yang Ming Chiao Tung University and conducted post-doctoral research at Lawrence Berkeley Laboratory in the USA.

Item 7. Management's Discussion & Analysis

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

12 edited+5 added−9 removed6 unchanged
Biggest changeGuo-Liang Yu (4) 8,683,038 9.33 % Dr. Sanjeev Redkar (5) 7,220,843 7.77 % Dr. Kin-Hung Peony Yu (6) 1,749,223 1.92 % Dr. Matthew Plunkett — — Dr. Kenneth C. Carter (7) 13,862 * Dr. Hong-Jung (Moses) Chen (2)(3)(7) 6,390,162 7.14 % Wendy Hayes (7) 13,862 * Glenn S. Vraniak (7) 13,862 * Dr.
Biggest changeSanjeev Redkar (4) 77,162 6.77 % Tiger Brokers (NZ) Limited (5) 74,030 6.71 % Executive Officers and Directors Dr. Guo-Liang Yu (3) 94,928 8.28 % Dr. Sanjeev Redkar (4) 77,162 6.77 % Dr. Matthew Plunkett (6) 2,916 * Dr. Kenneth C. Carter (7) 2,428 * Dr. Hong-Jung (Moses) Chen (7) (8) 4,714 * Wendy Hayes (7) 2,428 * Glenn S.
For purposes of the table below, we deem shares subject to options that are currently exercisable or exercisable within 60 days of March 28, 2024, and restricted share units that shall vest within 60 days of March 28, 2024, to be outstanding and to be beneficially owned by the person holding the options or restricted share units for the purposes of computing the percentage ownership of that person but we do not treat them as outstanding for the purpose of computing the percentage ownership of any other person.
For purposes of the table below, we deem shares subject to options that are currently exercisable or exercisable within 60 days of March 31, 2025, and restricted share units that shall vest within 60 days of March 31, 2025, to be outstanding and to be beneficially owned by the person holding the options or restricted share units for the purposes of computing the percentage ownership of that person but we do not treat them as outstanding for the purpose of computing the percentage ownership of any other person.
Major Sh areholders The following table sets forth information with respect to the beneficial ownership of our shares as of December 31, 2023 by: • each person or entity known by us to own beneficially more than 5% of our outstanding shares; • each of our directors and executive officers individually; and • all of our executive officers and directors as a group.
Major Sh areholders The following table sets forth information with respect to the beneficial ownership of our shares as of March 31, 2025 by: • each person or entity known by us to own beneficially more than 5% of our outstanding shares; • each of our directors and executive officers individually; and • all of our executive officers and directors as a group.
Related party transaction policy Our board of directors has adopted a written related party transaction policy to set forth the policies and procedures for identifying related party transactions. 126 Table of Contents C. Interests of Ex perts and Counsel Not applicable.
Related party transaction policy Our board of directors has adopted a written related party transaction policy to set forth the policies and procedures for identifying related party transactions. C. Interests of Ex perts and Counsel Not applicable.
To our knowledge, other than as disclosed in the table above, our other filings with the SEC and this Annual Report, there has been no significant change in the percentage ownership held by any major shareholder since January 1, 2022.
To our knowledge, other than as disclosed in the table above, our other filings with the SEC and this Annual Report, there has been no significant change in the percentage ownership held by any major shareholder within the past three years.
The percentage of Apollomics Class A Ordinary Shares beneficially owned is computed on the basis of 89,495,790 Apollomics Class A Ordinary Shares outstanding on March 28, 2024. All of our shareholders, including the shareholders listed below, have the same voting rights attached to their Class A Ordinary Shares.
The percentage of Apollomics Class A Ordinary Shares beneficially owned is computed on the basis of 1,103,348 Apollomics Class A Ordinary Shares outstanding on March 31, 2025. All of our shareholders, including the shareholders listed below, have the same voting rights attached to their Class A Ordinary Shares.
The major shareholders listed above do not have voting rights with respect to their Class A Ordinary Shares that are different from the voting rights of other holders of our Class A Ordinary Shares. B. Related P arty Transactions The following is a description of our related party transactions since January 1, 2023.
The major shareholders listed above do not have voting rights with respect to their Class A Ordinary Shares that are different from the voting rights of other holders of our Class A Ordinary Shares.
(7) Includes 13,862 Class A Ordinary Shares issuable upon exercise of options granted under the Incentive Plans that have vested or will vest within 60 days of the date of this Annual Report.
Includes 2,916 Class A Ordinary Shares issuable upon exercise of options granted under the Incentive Plans that have vested or will vest within 60 days of March 31, 2025. 7. Includes 2,290 Class A Ordinary Shares issuable upon exercise of options granted under the Incentive Plans that have vested or will vest within 60 days of March 31, 2025. 8.
(5) Includes 2,830,643 Class A Ordinary Shares issuable upon exercise of options granted under the Incentive Plans that have vested or will vest within 60 days of the date of this Annual Report.
Also includes 37,028 Class A Ordinary Shares issuable upon exercise of options granted under the Incentive Plans that have vested or will vest within 60 days of the date of this Annual Report. 5. The address for Tiger Brokers (NZ) Limited is Level 27, 151 Queen St, Auckland Central 1010, New Zealand. 6.
(4) Includes 2,967,375 Class A Ordinary Shares issuable upon exercise of options granted under the Incentive Plans that have vested or will vest within 60 days of the date of this Annual Report.
Also includes 43,456 Class A Ordinary Shares issuable upon exercise of options granted under the Incentive Plans that have vested or will vest within 60 days of March 31, 2025. 103 Table of Contents 4. Includes 38,237 Class A Ordinary Shares held by The Redkar Family Revocable Trust.
(6) Includes 1,480,165 Class A Ordinary Shares issuable upon exercise of options granted under the Incentive Plans that have vested or will vest within 60 days of the date of this Annual Report.
Includes 304 Class A Ordinary Shares issuable upon exercise of outstanding warrants. 9. Includes 1,398 Class A Ordinary Shares issuable upon vesting of restricted share units granted under the 2023 Incentive Plan that have vested or will vest within 60 days of March 31, 2025.
“ Major Shareholders and Related Party Transactions—Related Party Transactions .” 5% Holders: Number of Apollomics Class A Ordinary Shares Beneficially Owned Percentage of Total Voting Power OrbiMed Advisors LLC (1)(2) 8,582,858 9.58 % Alpha Intelligence Enterprises Limited (1) 7,750,530 8.66 % Shanghai Chongmao Investment Center LP (1) 7,397,212 8.27 % Name and Address of Beneficial Owners Executive Officers and Directors Dr.
“ Major Shareholders and Related Party Transactions—Related Party Transactions .” Name of Beneficial Owner Greater than 5% Shareholders Number of Apollomics Class A Ordinary Shares Beneficially Owned Percentage of Total Voting Power Hung-Wen Chen (1) 133,334 12.08 % Maxpro Investment Co., Ltd (2) 105,071 9.49 % Dr. Guo-Liang Yu (3) 94,928 8.28 % Dr.
Removed
Jonathan Wang (8) 336,418 * All Executive Officers and Directors as a Group 24,421,270 24.78 % * 125 Table of Contents (1) 8,582,857 Apollomics Ordinary Shares, consisting of (i) 595,146 Apollomics Class A Ordinary Shares; and (ii) 7,937,712 Apollomics Class B Ordinary Shares (consisting of (i) 7,937,712 Apollomics Class B Ordinary Shares issued as part of the consideration issued to existing Apollomics shareholders as part of the Business Combination); (iii) 35,840 Class A Ordinary Shares issuable upon exercise of options granted under the Incentive Plans that have vested or will vest within 60 days of the date of this Annual Report; and (iv) 14,160 Class A Ordinary Shares issuable upon exercise of Penny Warrants are held of record by OrbiMed Asia Partners II, LP (“OAP2”).
Added
Vraniak (7) 2,428 * Dr. Robert (Bob) Lin (9) 1,398 * All Executive Officers and Directors as a Group 188,402 15.73 % * Indicates ownership of less than 1% 1.
Removed
OrbiMed Advisors LLC (“OrbiMed Advisors”) is the advisory company to the OAP2. OrbiMed Advisors may be deemed to have voting power and investment power over the securities held by the OAP2 and, as a result, may be deemed to have beneficial ownership over such securities. OrbiMed Advisors exercises voting and investment power through a management committee comprised of Carl L.
Added
Based on information contained in the Schedule 13G filed with the SEC on May 20, 2024 by Hung-Wen Chen, Hung-Wen Chen held 13,333,333 Class A ordinary shares, which became 133,334 Class A Ordinary shares after giving effect to the reverse share split, effective as of November 25, 2024.
Removed
Gordon, Sven H. Borho and W. Carter Neild, each of whom disclaims beneficial ownership of the securities held by the OAP2, except to the extent of their pecuniary interest therein.
Added
The address for Hung-wen Chen is 4F, No. 6, Lane 8, Qingtian Street, Da’an District, Taipei City 106 Taiwan. 2. Consists of 101,248 Class A Ordinary shares held by Maxpro Investment Co., Ltd and 3,823 Class A ordinary shares issuable upon exercise of warrants exercisable within 60 days of March 31, 2025.
Removed
(2) Includes 619,400 Apollomics Class A Ordinary Shares consisting of (i) 464,150 Apollomics Class A Ordinary Shares underlying the Private Warrants and (ii) 155,250 Apollomics Class A Ordinary Shares underlying the Warrants underlying the units issued to the securityholder pursuant to a convertible promissory note.
Added
The address for Maxpro Investment Co., Ltd is 5F-4, No.89, Songren Rd., Xinyi District., Taipei City, Taiwan 11073. 3. Includes 11,653 Class A Ordinary Shares held by the Guo-Liang Yu and Yingfei Wei Trust and 890 Class A Ordinary Shares held by Tournament Bioventure LLC.
Removed
MP One Investment LLC, Maxpro’s sponsor, (the “Sponsor”) is the record holder of the securities reported herein. MP One Investment LLC is controlled by Chen, Hong – Jung (Moses), Maxpro’s Chairman and Chief Executive Officer, and Song, Yung-Fong (Ron), Maxpro’s Chief Strategy Officer.
Added
A description of any material relationship that our principal shareholders have had with us or any of our affiliates since January 1, 2024 is included under Item 7.B. “ Major Shareholders and Related Party Transactions—Related Party Transactions .” B. Related P arty Transactions The following is a description of our related party transactions since January 1, 2024.
Removed
By virtue of this relationship, Chen, Hong – Jung (Moses) and Song, Yung-Fong (Ron) may be deemed to share beneficial ownership of the securities held of record by the Sponsor. Chen, Hong – Jung (Moses) and Song, Yung-Fong (Ron) each disclaims any such beneficial ownership except to the extent of his pecuniary interest.
Removed
(3) Includes 2,625,000 Apollomics Class A Ordinary Shares issuable upon conversion of 2,100,000 Apollomics Series A Preferred Shares issued to Maxpro Investment Co., Ltd. in the PIPE. Maxpro Investment Co., Ltd. is controlled by Chen, Hong – Jung (Moses), Maxpro’s Chief Executive Officer and Chairman, and Chen, Yi – Kuei (Alex), a member of the Maxpro Board.
Removed
By virtue of this relationship, Chen, Hong – Jung (Moses) and Chen, Yi – Kuei (Alex) may be deemed to share beneficial ownership of the securities held of record by Maxpro Investment Co., Ltd. Chen, Hong – Jung (Moses) and Chen, Yi – Kuei (Alex) each disclaims any such beneficial ownership except to the extent of his pecuniary interest.
Removed
(8) Includes 336,418 Class A Ordinary Shares issuable upon exercise of options granted under the Incentive Plans that have vested or will vest within 60 days of the date of this Annual Report.

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