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What changed in Apollomics Inc.'s 20-F — 2022 vs 2023

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Paragraph-level year-over-year comparison of Apollomics Inc.'s 2022 and 2023 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 2023 report.

+1141 added−1341 removedSource: 20-F (2024-03-28) vs 20-F (2023-04-28)

Top changes in Apollomics Inc.'s 2023 20-F

1141 paragraphs added · 1341 removed · 901 edited across 6 sections

Item 2. Properties

Properties — owned and leased real estate

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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. 100 A. HISTORY AND DEVELOPMENT OF THE COMPANY 100 B. BUSINESS OVERVIEW 102 C. ORGANIZATIONAL STRUCTURE 173 D.
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.

Item 3. Legal Proceedings

Legal Proceedings — active lawsuits and investigations

425 edited+101 added−302 removed360 unchanged
Biggest changeIf the IRS were to successfully challenge under Section 7874 of the Code our status as a foreign corporation for U.S. federal income tax purposes, we and certain of our shareholders would be subject to significant adverse tax consequences, including a higher effective corporate income tax rate on us and future withholding taxes on certain of our shareholders, depending on the application of any income tax treaty that might apply to reduce such withholding taxes. 43 Table of Contents Investors should consult their own advisors regarding the potential application of Section 7874 of the Code to us.] We qualify as an “emerging growth company” within the meaning of the Securities Act, and if we take advantage of certain exemptions from disclosure requirements available to emerging growth companies, 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.
Biggest changeIf the IRS were to successfully challenge our status as a foreign corporation for U.S. federal income tax purposes under Section 7874 of the Code, we and certain of our shareholders would be subject to significant adverse tax consequences, including a higher effective corporate income tax rate on us and future withholding taxes on certain of our shareholders, depending on the application of any income tax treaty that might apply to reduce such withholding taxes.
We will have to pay any amount awarded by a court or negotiated in a settlement that exceed our coverage limitations or that are not covered by our insurance, and we may not have, or be able to obtain, sufficient capital to pay such amounts.
We will have to pay any amount awarded by a court or negotiated in a settlement that exceed our coverage limitations or that are not covered by our insurance, and we may not have, or be able to obtain, sufficient capital to pay such amounts.
The IRS may not agree that we should be treated as a non-U.S. corporation for U.S. federal income tax purposes A corporation is generally considered for U.S. federal income tax purposes to be a tax resident in the jurisdiction of its organization and incorporation.
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. A corporation is generally considered for U.S. federal income tax purposes to be a tax resident in the jurisdiction of its organization and incorporation.
However, the application of Section 7874 of the Code is complex, is subject to detailed rules and regulations (the application of which is uncertain in various respects, could be impacted by changes in such rules and regulations, with possible retroactive effect).
However, the application of Section 7874 of the Code is complex, is subject to detailed rules and regulations (the application of which is uncertain in various respects, and could be impacted by changes in such rules and regulations, with possible retroactive effect).
FDA expressed concerns with clinical data collected from a single country outside of the United States due to lack of diversity, differences in standard of care between the United States and China and a perceived higher incidence of data integrity issues identified in clinical studies in China.
The FDA expressed concerns with clinical data collected from a single country outside of the United States due to lack of diversity, differences in standard of care between the United States and China and a perceived higher incidence of data integrity issues identified in clinical studies in China.
If safety, efficacy, or other issues arise with any medical product that is used in combination with our drug candidates, we may be unable to market such drug candidate or may experience significant regulatory delays. Our strategy to develop combination therapies depends on the safety and efficacy of each component drug within each combination therapy.
If safety, efficacy, or other issues arise with any medical product that is used in combination with our product candidates, we may be unable to market such product candidate or may experience significant regulatory delays. Our strategy to develop combination therapies depends on the safety and efficacy of each component drug within each combination therapy.
Any failure to maintain or implement required new or improved controls, or any difficulties we encounter in the implementation of new or improved controls, could result in additional significant deficiencies or material weaknesses, cause us to fail to meet the periodic reporting obligations or result in material misstatements in the financial statements.
Any failure to maintain or implement required new or improved controls, or any difficulties we encounter in the implementation of new or improved controls, could result in additional significant deficiencies or material weaknesses, cause us to fail to meet periodic reporting obligations or result in material misstatements in the financial statements.
Any such failure could also adversely affect the results of periodic management evaluations regarding the effectiveness of the internal control over financial reporting.
Any such failure could also adversely affect the results of periodic management evaluations regarding the effectiveness of internal control over financial reporting.
None of the Private Warrants will be redeemable by us so long as they are held by their initial purchasers or their permitted transferees. In the event that we elect to redeem all of the redeemable warrants as described above, we will fix a date for the redemption.
None of the Private Warrants will be redeemable by date us so long as they are held by their initial purchasers or their permitted transferees. In the event that we elect to redeem all of the redeemable warrants as described above, we will fix a date for the redemption.
Any potential acquisition or strategic partnership may entail numerous risks, including: • increased operating expenses and cash requirements; • the assumption of additional indebtedness or contingent or unforeseen liabilities; • the issuance of our equity securities; • assimilation of operations, intellectual property rights and products of an acquired company, including difficulties associated with integrating new personnel; • retention of key employees, the loss of key personnel, and uncertainties in our ability to maintain key business relationships; • risks and uncertainties associated with the other party to such a transaction, including the prospects of that party and their existing drugs or drug candidates and regulatory approvals; • the diversion of our management’s attention from our existing product programs and initiatives in pursuing such a strategic merger or acquisition; and • our inability to generate revenue from acquired technology and/or products sufficient to meet our objectives in undertaking the acquisition or even to offset the associated acquisition and maintenance costs.
Any potential acquisition or strategic partnership may entail numerous risks, including: • increased operating expenses and cash requirements; • the assumption of additional indebtedness or contingent or unforeseen liabilities; • the issuance of our equity securities; • assimilation of operations, intellectual property rights and products of an acquired company, including difficulties associated with integrating new personnel; • retention of key employees, the loss of key personnel, and uncertainties in our ability to maintain key business relationships; • risks and uncertainties associated with the other party to such a transaction, including the prospects of that party and their existing drugs or product candidates and regulatory approvals; • the diversion of our management’s attention from our existing product programs and initiatives in pursuing such a strategic merger or acquisition; and • our inability to generate revenue from acquired technology and/or products sufficient to meet our objectives in undertaking the acquisition or even to offset the associated acquisition and maintenance costs.
These transactions can entail numerous operational and financial risks, including exposure to unknown liabilities, disruption of our business and diversion of our management’s time and attention in order to manage a collaboration or develop acquired products, product candidates or technologies, incurrence of substantial debt or dilutive issuances of equity securities to pay transaction consideration or costs, higher than expected collaboration, acquisition or integration costs, write-downs of assets or goodwill or impairment charges, increased amortization expenses, difficulty and cost in facilitating the collaboration or combining the operations and personnel of any acquired business, impairment of relationships with key suppliers, manufacturers or customers of any acquired business due to changes in management and ownership and the inability to retain key employees of any acquired business.
These transactions can also entail numerous operational and financial risks, including exposure to unknown liabilities, disruption of our business and diversion of our management’s time and attention in order to manage a collaboration or develop acquired products, product candidates or technologies, incurrence of substantial debt or dilutive issuances of equity securities to pay transaction consideration or costs, higher than expected collaboration, acquisition or integration costs, write-downs of assets or goodwill or impairment charges, increased amortization expenses, difficulty and cost in facilitating the collaboration or combining the operations and personnel of any acquired business, impairment of relationships with key suppliers, manufacturers or customers of any acquired business due to changes in management and ownership and the inability to retain key employees of any acquired business.
We will remain an emerging growth company until the earliest of (i) the last day of the fiscal year in which the market value of our ordinary shares that are held by non-affiliates is equal to or exceeds $700 million as of the end of that year’s second fiscal quarter, (ii) the last day of the fiscal year in which we have total annual gross revenue of $1.235 billion or more during such fiscal year (as indexed for inflation), (iii) the date on which we have 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 first sale of Apollomics Class A Ordinary Shares following the consummation of the Business Combination.
We will remain an emerging growth company 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 is equal to or exceeds $700 million as of the end of that year’s second fiscal quarter, (ii) the last day of the fiscal year in which we have total annual gross revenue of $1.235 billion or more during such fiscal year (as indexed for inflation), (iii) the date on which we have 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 first sale of Class A Ordinary Shares following the consummation of the Business Combination.
Risks Related to our Intellectual Property Rights If we are unable to obtain and maintain patent protection for our drug 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.
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 have the ability to redeem outstanding Public Warrants at any time after they become exercisable and prior to their expiration, at a price of $0.01 per warrant, provided that the last reported sales price of our ordinary shares equals or exceeds $18.00 per share for any 20 trading days within a 30-trading day period ending on the third trading day prior to the date we give notice of redemption.
We have the ability to redeem outstanding Public Warrants at any time after they become exercisable and prior to their expiration, at a price of $0.01 per warrant, provided that the last reported sales price of our Class A Ordinary Shares equals or exceeds $18.00 per share for any 20 trading days within a 30-trading day period ending on the third trading day prior to the date we give notice of redemption.
The success of our drug candidates will depend on several factors, including but not limited to the successful completion of preclinical and/or clinical trials or studies, receipt of regulatory approvals from applicable regulatory authorities for planned clinical trials, future clinical trials or drug registrations, maintaining adequate manufacturing capabilities and capacities, commercialization of our existing drug candidates, hiring sufficient technical experts to oversee all development and regulatory activities and license renewal and meeting of the safety requirements.
The success of our product candidates will depend on several factors, including but not limited to the successful completion of preclinical and/or clinical trials or studies, receipt of regulatory approvals from applicable regulatory authorities for planned clinical trials, future clinical trials or drug registrations, maintaining adequate manufacturing capabilities and capacities, commercialization of our existing product candidates, hiring sufficient technical experts to oversee all development and regulatory activities and license renewal and meeting of the safety requirements.
Even if we obtain coverage for a given drug, the resulting reimbursement rates might not be adequate for us to achieve or sustain profitability or may require co-payments that patients find unacceptably high. Additionally, third-party payors may not cover, or provide adequate reimbursement for, long-term follow-up evaluations required following the use of our future approved drug candidates.
Even if we obtain coverage for a given drug, the resulting reimbursement rates might not be adequate for us to achieve or sustain profitability or may require co-payments that patients find unacceptably high. Additionally, third-party payors may not cover, or provide adequate reimbursement for, long-term follow-up evaluations required following the use of our future approved product candidates.
For example, our drug 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 drug 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 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.
Investment in pharmaceutical drug development is highly speculative, as it entails substantial upfront capital expenditures and significant risk that a drug candidate will fail to gain regulatory approval or become commercially viable. We continue to incur significant expenses related to our ongoing operations and drug development. We have incurred losses in each period since our inception.
Investment in pharmaceutical drug development is highly speculative, as it entails substantial upfront capital expenditures and significant risk that a product candidate will fail to gain regulatory approval or become commercially viable. We continue to incur significant expenses related to our ongoing operations and drug development. We have incurred losses in each period since our inception.
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 drug 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, including the COVID-19 pandemic, 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; • 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.
Even if litigation or other proceedings are resolved in our favor, there could be public announcements of the results of hearings, motions or other interim proceedings or developments, and if securities analysts or investors perceive these results to be negative, it could have a substantial adverse effect on the market price of our ordinary shares.
Even if litigation or other proceedings are resolved in our favor, there could be public announcements of the results of hearings, motions or other interim proceedings or developments, and if securities analysts or investors perceive these results to be negative, it could have a substantial adverse effect on the market price of our Class A Ordinary Shares.
In addition, any new product that competes with an approved product must demonstrate compelling advantages in efficacy, convenience, tolerability and/or safety in order to overcome price competition and to be commercially successful. Disruptive technologies and medical breakthroughs may further intensify the competition and render our drug candidates obsolete or non-competitive.
In addition, any new product that competes with an approved product must demonstrate compelling advantages in efficacy, convenience, tolerability and/or safety in order to overcome price competition and to be commercially successful. Disruptive technologies and medical breakthroughs may further intensify the competition and render our product candidates obsolete or non-competitive.
However, for as long as we are an “emerging growth company” under the JOBS Act, the independent registered public accounting firm will not be required to attest to the effectiveness of the internal control over financial reporting pursuant to Section 404. We could be an emerging growth company for up to five years.
However, for as long as we are an “emerging growth company” under the JOBS Act, our independent registered public accounting firm will not be required to attest to the effectiveness of internal control over financial reporting pursuant to Section 404. We could be an emerging growth company for up to five years.
Failure can occur at any time during the preclinical study, investigational new drug applications and/or clinical trial processes, and, because our drug candidates are in early stages of development, there is a high risk of failure and we may never succeed in developing marketable products.
Failure can occur at any time during the preclinical study, investigational new drug applications and/or clinical trial processes, and, because our product candidates are in early stages of development, there is a high risk of failure and we may never succeed in developing marketable products.
If such undesirable side effects caused by such drug 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 drug 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 drug candidates are distributed or administered, or change the labeling of the drug candidates; • 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; 23 Table of Contents • 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 drug 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; 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 we are unable to develop marketing and sales capabilities or enter into agreements with third parties to market and sell our drug candidates, we may not be able to generate product sales revenue. We have collaboration relationships with several biotechnology companies, and it is our plan to launch and market drug candidates with our partners.
If we are unable to develop marketing and sales capabilities or enter into agreements with third parties to market and sell our product candidates, we may not be able to generate product sales revenue. We have collaboration relationships with several biotechnology companies, and it is our plan to launch and market product candidates with our partners.
We may have little or no control over the marketing and sales efforts of such third parties, and our revenue from product sales may be lower than if we had commercialized our drug candidates ourselves. We also face competition in our search for third parties to assist us with the sales and marketing efforts for our drug candidates.
We may have little or no control over the marketing and sales efforts of such third parties, and our revenue from product sales may be lower than if we had commercialized our product candidates ourselves. We also face competition in our search for third parties to assist us with the sales and marketing efforts for our product candidates.
In addition, any delays in completing our clinical trials will increase our costs, slow down our drug candidate development and approval process, and jeopardize our ability to commence product sales and generate related revenues for that candidate. Any of these occurrences may harm our business, financial condition and prospects significantly.
In addition, any delays in completing our clinical trials will increase our costs, slow down our product candidate development and approval process, and jeopardize our ability to commence product sales and generate related revenues for that candidate. Any of these occurrences may harm our business, financial condition and prospects significantly.
Compliance with public company requirements will increase costs and make certain activities more time-consuming. A number of these requirements require us to carry out activities we did not previously conduct as a private company. In addition, expenses associated with SEC reporting requirements are being incurred.
Compliance with public company requirements will increase costs and make certain activities time-consuming. A number of these requirements require us to carry out activities we did not previously conduct as a private company. In addition, expenses associated with SEC reporting requirements are being incurred.
If we experience delays in the completion of, or the termination of, a clinical trial of any of our drug candidates, the commercial prospects of that drug candidate will be impaired, and our ability to generate product sales revenues from any of those drug candidates will be delayed or may not materialize at all.
If we experience delays in the completion of, or the termination of, a clinical trial of any of our product candidates, the commercial prospects of that product candidate will be impaired, and our ability to generate product sales revenues from any of those product candidates will be delayed or may not materialize at all.
We may issue additional 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 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.
Following any approval for commercial sale of our drug 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 drug 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, NMPA, and comparable regulatory authorities. Also, regulatory approval for any of our product candidates may be withdrawn.
If we fail to enter into collaborations and do not have sufficient funds or expertise to undertake the necessary development and commercialization activities, we may not be able to further develop our drug candidates or bring them to market and generate product sales revenue.
If we fail to enter into collaborations and do not have sufficient funds or expertise to undertake the necessary development and commercialization activities, we may not be able to further develop our product candidates or bring them to market and generate product sales revenue.
Our drug candidates will require completion of their clinical development, regulatory review, significant marketing efforts and substantial investment before they can provide us with product sales revenue. Our operations have consumed substantial amounts of cash since inception.
Our product candidates will require completion of their clinical development, regulatory review, significant marketing efforts and substantial investment before they can provide us with product sales revenue. Our operations have consumed substantial amounts of cash since inception.
Each of our drug candidates will require additional preclinical and/or clinical development, regulatory approvals in multiple jurisdictions, development of manufacturing and supply capacity, substantial investment and significant marketing efforts before we generate any revenue from product sales.
Each of our product candidates will require additional preclinical and/or clinical development, regulatory approvals in multiple jurisdictions, development of manufacturing and supply capacity, substantial investment and significant marketing efforts before we generate any revenue from product sales.
Product liability claims or lawsuits could cause us to incur substantial liabilities. We face an inherent risk of product liability exposure related to the use of our drug candidates and the testing of our drug candidates in human clinical trials.
Product liability claims or lawsuits could cause us to incur substantial liabilities. We face an inherent risk of product liability exposure related to the use of our product candidates and the testing of our product candidates in human clinical trials.
If the FDA, NMPA or comparable regulatory authority revokes its approval of another therapeutic product we use in combination with our drug candidates, we will not be able to market our drug candidates in combination with such revoked therapeutic product.
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.
We currently use third party CMOs, including single source suppliers, for our manufacturing process and/or for the clinical supply of our drug candidates. We do not own manufacturing facilities for producing any clinical trial product supplies.
We currently use third party CMOs, including single source suppliers, for our manufacturing process and/or for the clinical supply of our product candidates. We do not own manufacturing facilities for producing any clinical trial product supplies.
Given the term “state secret” is not clearly defined, if and to the extent our R&D of drug candidates will be subject to the Scientific Data Measures and any subsequent laws as required by the relevant government authorities, we cannot assure you that our partners in China can always obtain relevant approvals for sending scientific data (such as the results of our preclinical studies or clinical trials conducted within China) to us.
Given the term “state secret” is not clearly defined, if and to the extent our R&D of product candidates will be subject to the Scientific Data Measures and any subsequent laws as required by the relevant government authorities, we cannot assure you that our partners in China can always obtain relevant approvals for sending scientific data (such as the results of our preclinical studies or clinical trials conducted within China) to us.
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 drug 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 drug candidates, or if there are safety, potency or efficacy concerns associated with our drug candidates, we may be prevented from or delayed in obtaining marketing approval for such drug 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 approval for such product candidates.
New laws, regulations, and other government directives in the PRC may also be costly to comply with, and such compliance or any associated inquiries or investigations or any other government actions may delay or impede our operations and development in the PRC and subject Apollomics to remedies, administrative penalties and even criminal liabilities that may harm its business, including fines assessed for its current or historical operations, or demands or orders that it modify or even cease its business practices in the PRC.
New laws, regulations, and other government directives in the PRC may also be costly to comply with, and such compliance or any associated inquiries or investigations or any other government actions may delay or impede our operations and development in the PRC and subject us to remedies, administrative penalties and even criminal liabilities that may harm its business, including fines assessed for its current or historical operations, or demands or orders that it modify or even cease its business practices in the PRC.
If unacceptable side effects arise in the development of our drug 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 drug 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 drug candidates for any or all indications we are pursuing.
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 we do not achieve one or more of these in a timely manner or at all, we could experience significant delays in our ability to obtain approval for our drug candidates, which would materially harm our business and we may not be able to generate sufficient revenues and cash flows to continue our operations, and therefore have a materially adversely effect on our business, financial condition, results of operations and prospect.
If we do not achieve one or more of these in a timely manner or at all, we could experience significant delays in our ability to obtain approval for our product candidates, which would materially harm our business and we may not be able to generate sufficient revenues and cash flows to continue our operations, and therefore have a materially adversely effect on our business, financial condition, results of operations and prospect.
If CROs do not successfully carry out their contractual duties or obligations or meet expected deadlines, if they need to be replaced or if the quality or accuracy of the clinical data they or our clinical investigators obtain is compromised due to failure to adhere to our clinical protocols, regulatory requirements or for other reasons, our clinical trials may be extended, delayed or terminated and we may not be able to obtain regulatory approval for or successfully commercialize our drug candidates.
If CROs do not successfully carry out their contractual duties or obligations or meet expected deadlines, if they need to be replaced or if the quality or accuracy of the clinical data they or our clinical investigators obtain is compromised due to failure to adhere to our clinical protocols, regulatory requirements or for other reasons, our clinical trials may be extended, delayed or terminated and we may not be able to obtain regulatory approval for or successfully commercialize our product candidates.
Patients are unlikely to use any of our future approved drug candidates unless coverage is provided and reimbursement is adequate to cover a significant portion of the cost of the drug.
Patients are unlikely to use any of our future approved product candidates unless coverage is provided and reimbursement is adequate to cover a significant portion of the cost of the drug.
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 drug candidates or competing drug 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 drug 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 drug candidates, which may change from time to time; • the cost of manufacturing our drug 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 drug candidates; • the level of demand for our drug candidates should they receive approval, which may vary significantly; • the risk/benefit profile, cost and reimbursement policies with respect to our drug candidates, if approved, and existing and potential future therapeutics that compete with our drug candidates; • general market conditions or extraordinary external events, such as a recession or the COVID-19 pandemic; • 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 environments; and • future accounting pronouncements or changes in our accounting policies.
The degree of market acceptance of our drug candidates, even if approved for commercial sale, will depend on a number of factors, including, but not limited to: • the clinical indications for which our drug candidates are approved; • the views of physicians, hospitals, cancer treatment centers and patients considering our drug candidates as a safe and effective treatment; • the potential and perceived advantages of our drug candidates over alternative treatments; • the timing of market introduction of our drug candidates as well as competitive drugs and generics; • the prevalence and severity of any side effects for our product candidates compared to the prevalence and severity of any side effects for conventional products and other cell therapies; • product labeling or product insert requirements of regulatory authorities; 67 Table of Contents • limitations or warnings contained in the labeling approved by regulatory authorities; • the cost of treatment in relation to alternative treatments; • the availability of adequate coverage, reimbursement and pricing by third-party payors and government authorities; • relative convenience and ease of administration, including as compared to alternative treatments and competitive therapies; • the willingness of patients to pay out-of-pocket in the absence of coverage and reimbursement by third-party payors and government authorities; and • the effectiveness of our sales and marketing efforts.
The degree of market acceptance of our product candidates, even if approved for commercial sale, will depend on a number of factors, including, but not limited to: • the clinical indications for which our product candidates are approved; • the views of physicians, hospitals, cancer treatment centers and patients considering our product candidates as a safe and effective treatment; • the potential and perceived advantages of our product candidates over alternative treatments; • the timing of market introduction of our product candidates as well as competitive drugs and generics; • the prevalence and severity of any side effects for our product candidates compared to the prevalence and severity of any side effects for conventional products and other cell therapies; • product labeling or product insert requirements of regulatory authorities; • limitations or warnings contained in the labeling approved by regulatory authorities; • the cost of treatment in relation to alternative treatments; • the availability of adequate coverage, reimbursement and pricing by third-party payors and government authorities; • relative convenience and ease of administration, including as compared to alternative treatments and competitive therapies; • the willingness of patients to pay out-of-pocket in the absence of coverage and reimbursement by third-party payors and government authorities; and • the effectiveness of our sales and marketing efforts.
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.
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.
In some instances, there can be significant variability in safety, bioavailability, potency or efficacy results between different preclinical studies and clinical trials of the same drug candidate due to numerous factors, including changes in manufacturing, trial procedures set forth in protocols, differences in the size and type of the patient populations, changes in and adherence to the clinical trial protocols, and the rate of enrollment and/or dropout among clinical trial participants.
In some instances, there can be significant variability in safety, bioavailability, potency or efficacy results between different preclinical studies and clinical trials of the same product candidate due to numerous factors, including changes in manufacturing, trial procedures set forth in protocols, differences in the size and type of the patient populations, changes in and adherence to the clinical trial protocols, and the rate of enrollment and/or dropout among clinical trial participants.
Even if we are able to enroll a sufficient number of patients in our clinical trials, delays in patient enrollment may result in increased costs or may affect the timing or outcome of the planned clinical trials, which could prevent completion of these trials and materially adversely affect our ability to advance the development of our drug candidates, which in turn could materially adversely affect our business, financial condition, results of operations and prospects.
Even if we are able to enroll a sufficient number of patients in our clinical trials, delays in patient enrollment may result in increased costs or may affect the timing or outcome of the planned clinical trials, which could prevent completion of these trials and materially adversely affect our ability to advance the development of our product candidates, which in turn could materially adversely affect our business, financial condition, results of operations and prospects.
Any of our future approved drug candidates will be subject to ongoing or additional regulatory requirements for manufacturing, labeling, packaging, storage, advertising, promotion, sampling, record-keeping, conduct of post-marketing studies, and submission of safety, efficacy, and other post-market information, including both federal and state requirements in the United States and requirements of comparable regulatory authorities in China and other countries.
Any of our future approved product candidates will be subject to ongoing or additional regulatory requirements for manufacturing, labeling, packaging, storage, advertising, promotion, sampling, record-keeping, conduct of post-marketing studies, and submission of safety, efficacy, and other post-market information, including both federal and state requirements in the United States and requirements of comparable regulatory authorities in China and other countries.
In addition, if the FDA, NMPA or a comparable regulatory authority approves our drug candidates, we will have to comply with requirements, including, for example, submissions of safety and other post-marketing information and reports, registration, as well as continued compliance with cGMP and good clinical practice, or GCP, for any clinical trials that we conduct post-approval.
In addition, if the FDA, NMPA or a comparable regulatory authority approves our product candidates, we will have to comply with requirements, including, for example, submissions of safety and other post-marketing information and reports, registration, as well as continued compliance with cGMP and good clinical practice, or GCP, for any clinical trials that we conduct post-approval.
In the event of a successful claim against us of infringement, misappropriation or other violation of intellectual property rights, or a settlement by us of any such claims, we may have to pay substantial damages, including treble damages and attorneys’ fees in the case of willful infringement, pay royalties and other payments or redesign our infringing drug candidate, which may be impossible or require substantial time and cost.
In the event of a successful claim against us of infringement, misappropriation or other violation of intellectual property rights, or a settlement by us of any such claims, we may have to pay substantial damages, including treble damages and attorneys’ fees in the case of willful infringement, pay royalties and other payments or redesign our infringing product candidate, which may be impossible or require substantial time and cost.
If we face allegations of non-compliance with laws and encounter sanctions, our reputation, revenues and liquidity may suffer, and our drug candidates and future drugs could be subject to restrictions or withdrawal from the market. Any government investigation of alleged violations of laws could require us to expend significant time and resources in response, and could generate negative publicity.
If we face allegations of non-compliance with laws and encounter sanctions, our reputation, revenues and liquidity may suffer, and our product candidates and future drugs could be subject to restrictions or withdrawal from the market. Any government investigation of alleged violations of laws could require us to expend significant time and resources in response, and could generate negative publicity.
Furthermore, we may not be able to obtain sufficient funding or generate sufficient revenue and cash inflows to continue the development of any other drug candidate in the future. Our drug candidates, once approved, may fail to achieve the degree of market acceptance by physicians, patients, third-party payors and others in the medical community necessary for commercial success.
Furthermore, we may not be able to obtain sufficient funding or generate sufficient revenue and cash inflows to continue the development of any other product candidate in the future. Our product candidates, once approved, may fail to achieve the degree of market acceptance by physicians, patients, third-party payors and others in the medical community necessary for commercial success.
Given the amount of time required for the development, testing and regulatory review of new drug candidates, patents protecting such assets might expire before or shortly after such assets are commercialized. As a result, our patent portfolio may not provide us with sufficient rights to exclude others from commercializing drug candidates similar or identical to ours.
Given the amount of time required for the development, testing and regulatory review of new product candidates, patents protecting such assets might expire before or shortly after such assets are commercialized. As a result, our patent portfolio may not provide us with sufficient rights to exclude others from commercializing product candidates similar or identical to ours.
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 drug 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 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.
We and our current and future collaborators may encounter difficulties in developing, obtaining regulatory approval for, manufacturing and commercializing companion diagnostics similar to those we face with respect to our drug candidates themselves, including issues with achieving regulatory clearance, authorization or approval, production of sufficient quantities at commercial scale and with appropriate quality standards, and in gaining market acceptance.
We and our current and future collaborators may encounter difficulties in developing, obtaining regulatory approval for, manufacturing and commercializing companion diagnostics similar to those we face with respect to our product candidates themselves, including issues with achieving regulatory clearance, authorization or approval, production of sufficient quantities at commercial scale and with appropriate quality standards, and in gaining market acceptance.
Before obtaining regulatory approvals for the commercial sale of any drug 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 drug 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, 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 our drug candidates, we must demonstrate through lengthy, complex and expensive preclinical studies and clinical trials that our drug candidates are both safe and effective for use in each target indication. Clinical testing is expensive and can take many years to complete and its outcome is inherently uncertain.
Before obtaining regulatory approvals for the commercial sale of our product candidates, we must demonstrate through lengthy, complex and expensive preclinical studies and clinical trials that our product candidates are both safe and effective for use in each target indication. Clinical testing is expensive and can take many years to complete and its outcome is inherently uncertain.
There can be no assurance that we will not encounter similar challenges or delays in the future or that these delays or challenges will not have a material adverse effect on our business, financial condition, results of operations and prospects. Cooperation of our R&D collaborators and partners working on our drug candidates are required for the success of our projects.
There can be no assurance that we will not encounter similar challenges or delays in the future or that these delays or challenges will not have a material adverse effect on our business, financial condition, results of operations and prospects. Cooperation of our R&D collaborators and partners working on our product candidates are required for the success of our projects.
For example, current cancer treatments like chemotherapy and radiation therapy are well established in the medical community, and doctors may continue to rely on these treatments to the exclusion of our drug candidates that are in clinical trials for the same or similar cancer indications. In addition, physicians, patients and third-party payors may prefer other products to ours.
For example, current cancer treatments like chemotherapy and radiation therapy are well established in the medical community, and doctors may continue to rely on these treatments to the exclusion of our product candidates that are in clinical trials for the same or similar cancer indications. In addition, physicians, patients and third-party payors may prefer other products to ours.
Under each of our license and intellectual property-related agreements, in exchange for licensing or sub-licensing us the right to develop and commercialize the applicable drug candidates, our licensors will be eligible to receive from us milestone payments, tiered royalties from commercial sales of such drug candidates, assuming relevant approvals from government authorities are obtained, or other payments.
Under each of our license and intellectual property-related agreements, in exchange for licensing or sub-licensing us the right to develop and commercialize the applicable product candidates, our licensors will be eligible to receive from us milestone payments, tiered royalties from commercial sales of such product candidates, assuming relevant approvals from government authorities are obtained, or other payments.
Moreover, we may not be successful in our efforts to establish a strategic partnership or other alternative arrangements for our drug candidates because they may be deemed to be at too early of a stage of development for collaborative effort and third parties may not view our drug candidates as having the requisite potential to demonstrate safety and efficacy or commercial viability.
Moreover, we may not be successful in our efforts to establish a strategic partnership or other alternative arrangements for our product candidates because they may be deemed to be at too early of a stage of development for collaborative effort and third parties may not view our product candidates as having the requisite potential to demonstrate safety and efficacy or commercial viability.
As a result, our business, results of operations and financial condition could be materially harmed. In addition, a diagnostic company with whom we contract may decide to discontinue selling or manufacturing the companion diagnostic test that we anticipate using in connection with development and commercialization of our drug candidates or our relationship with such diagnostic company may otherwise terminate.
As a result, our business, results of operations and financial condition could be materially harmed. In addition, a diagnostic company with whom we contract may decide to discontinue selling or manufacturing the companion diagnostic test that we anticipate using in connection with development and commercialization of our product candidates or our relationship with such diagnostic company may otherwise terminate.
We have in-licensed from our partners (i) global (excluding China, Hong Kong and Taiwan) rights of an IND-ready drug candidate, APL-122 and (ii) the Greater China and South Africa rights of a preclinical-stage cancer vaccine candidate, APL-810. These assets are important for our portfolio and in-licensing will remain important for our portfolio strategy.
We have in-licensed from our partners (i) global (excluding China, Hong Kong and Taiwan) rights of an IND-ready product candidate, APL-122 and (ii) the Greater China and South Africa rights of a preclinical-stage cancer vaccine candidate, APL-810. These assets are important for our portfolio and in-licensing will remain important for our portfolio strategy.
Our ability to commercialize any approved drug candidates successfully also will depend in part on the extent to which reimbursement for these drugs and related treatments will be available from government health administration authorities, private health insurers and other organizations. A primary trend in the global healthcare industry is cost containment.
Our ability to commercialize any approved product candidates successfully also will depend in part on the extent to which reimbursement for these drugs and related treatments will be available from government health administration authorities, private health insurers and other organizations. A primary trend in the global healthcare industry is cost containment.
The market opportunities for any current or future drug candidate we develop, if and when approved, may be limited to those patients who are ineligible for established therapies or for whom prior therapies have failed, and may be small. Cancer therapies are sometimes characterized as first-line, second-line or third-line, and many new therapies are initially approved only for third-line use.
The market opportunities for any current or future product candidate we develop, if and when approved, may be limited to those patients who are ineligible for established therapies or for whom prior therapies have failed, and may be small. Cancer therapies are sometimes characterized as first-line, second-line or third-line, and many new therapies are initially approved only for third-line use.
Thus, even if our patent applications issue as patents, they may not issue in a form that will provide us with any meaningful protection, prevent competitors from competing with us or otherwise provide us with any competitive advantage. Our competitors may be able to circumvent our patents by developing similar or alternative technologies or drug candidates in a non-infringing manner.
Thus, even if our patent applications issue as patents, they may not issue in a form that will provide us with any meaningful protection, prevent competitors from competing with us or otherwise provide us with any competitive advantage. Our competitors may be able to circumvent our patents by developing similar or alternative technologies or product candidates in a non-infringing manner.
If a third party does not offer us a necessary license or offers a license only on terms that are unattractive or unacceptable to us, we might be unable to develop and commercialize one or more of our drug candidates, which would have a material adverse effect on our business, financial condition, results of operations and prospects.
If a third party does not offer us a necessary license or offers a license only on terms that are unattractive or unacceptable to us, we might be unable to develop and commercialize one or more of our product candidates, which would have a material adverse effect on our business, financial condition, results of operations and prospects.
Significant preclinical study or clinical trial delays also could shorten any periods during which we may have the exclusive right to commercialize our drug candidates, or could allow our competitors to bring products to market before we do and impair our ability to successfully commercialize our drug candidates, which may harm our business, results of operations, financial condition and prospects.
Significant preclinical study or clinical trial delays also could shorten any periods during which we may have the exclusive right to commercialize our product candidates, or could allow our competitors to bring products to market before we do and impair our ability to successfully commercialize our product candidates, which may harm our business, results of operations, financial condition and prospects.
Other recent Oncology Center of Excellence initiatives have included Project FrontRunner, a new initiative with a goal of developing a framework for identifying candidate drugs for initial clinical development in the earlier advanced setting rather than for treatment of patients who have received numerous prior lines of therapies or have exhausted available treatment options.
Other recent Oncology Center of Excellence initiatives have included Project FrontRunner, an initiative with a goal of developing a framework for identifying candidate drugs for initial clinical development in the earlier advanced setting rather than for treatment of patients who have received numerous prior lines of therapies or have exhausted available treatment options.
We seek to protect the drug candidates and their use, components, formulations and methods of treatment, and technology that we consider commercially important by filing patent applications in the United States, China, Europe and other countries or regions, relying on trade secrets or pharmaceutical regulatory protection or employing a combination of these methods.
We seek to protect the product candidates and their use, components, formulations and methods of treatment, and technology that we consider commercially important by filing patent applications in the United States, China, Europe and other countries or regions, relying on trade secrets or pharmaceutical regulatory protection or employing a combination of these methods.
The PRC government’s exertion of more control over offerings conducted overseas and/or foreign investment in issuers based in mainland China could result in a material change in the operations of Apollomics’ PRC Subsidiaries, significantly limit or completely hinder Apollomics’ ability to offer or continue to offer securities to investors, and cause the value of Apollomics’ securities to significantly decline or be worthless.
The PRC government’s exertion of more control over offerings conducted overseas and/or foreign investment in issuers based in mainland China could result in a material change in the operations of our PRC Subsidiaries, significantly limit or completely hinder our ability to offer or continue to offer securities to investors, and cause the value of our securities to significantly decline or be worthless.
If our drug candidates do not achieve an adequate level of acceptance, we may not generate significant product sales revenues and we may not become profitable.
If our product candidates do not achieve an adequate level of acceptance, we may not generate significant product sales revenues and we may not become profitable.
Subsequently, for those products that prove to be sufficiently beneficial, if any, we would expect to seek approval potentially as a first-line therapy, but there is no guarantee that drug candidates we develop, even if approved, would be approved for first-line therapy, and, prior to any such approvals, we may have to conduct additional clinical trials.
Subsequently, for those products that prove to be sufficiently beneficial, if any, we would expect to seek approval potentially as a first-line therapy, but there is no guarantee that product candidates we develop, even if approved, would be approved for first-line therapy, and, prior to any such approvals, we may have to conduct additional clinical trials.
These drugs may compete with our drug candidates and our patent rights or other intellectual property rights may not be effective or adequate to prevent them from competing. We currently have trademark applications pending, any of which may be the subject of a governmental or third-party objection, which could prevent the registration of the same.
These drugs may compete with our product candidates and our patent rights or other intellectual property rights may not be effective or adequate to prevent them from competing. We currently have trademark applications pending, any of which may be the subject of a governmental or third-party objection, which could prevent the registration of the same.
As a result, we may not be able to realize the benefit of current or future collaborations, strategic partnerships or the license of our drug candidates if we are unable to successfully integrate such collaborations with our existing operations and company culture, which could delay our timelines or otherwise adversely affect our business.
As a result, we may not be able to realize the benefit of current or future collaborations, strategic partnerships or the license of our product candidates if we are unable to successfully integrate such collaborations with our existing operations and company culture, which could delay our timelines or otherwise adversely affect our business.
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 complied fully with the Nasdaq listing standards.
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.
The Articles provides further that unless we consent in writing to the selection of an alternative forum, the federal district courts of the United States shall, to the fullest extent permitted by law, be the sole and exclusive forum for the resolution of any complaint asserting a cause of action arising under the Securities Act.
The MAA provides further that unless we consent in writing to the selection of an alternative forum, the federal district courts of the United States shall, to the fullest extent permitted by law, be the sole and exclusive forum for the resolution of any complaint asserting a cause of action arising under the Securities Act.
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 drug 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, 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.

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Item 4. Mine Safety Disclosures

Mine Safety Disclosures — required of mining issuers

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Biggest changeOther federal statutes pertaining to healthcare fraud and abuse include the Civil Monetary Penalties Law statute, which prohibits, among other things, the offer or payment of remuneration to a Medicaid or Medicare beneficiary that the offeror or payor knows or should know is likely to influence the beneficiary to order or receive a reimbursable item or service from a particular supplier, and the additional federal criminal statutes created by HIPAA, which prohibit, among other things, knowingly and willfully executing or attempting to execute a scheme to defraud any healthcare benefit program or obtain by means of false or fraudulent pretenses, representations or promises any money or property owned by or under the control of any healthcare benefit program in connection with the delivery of or payment for healthcare benefits, items or services. 159 Table of Contents In addition, HIPAA, as amended by the Health Information Technology for Economic and Clinical Health Act of 2009 (“HITECH”), and their respective implementing regulations, including the Final Omnibus Rule published on January 25, 2013, impose obligations on certain healthcare providers, health plans and healthcare clearinghouses, known as covered entities, as well as their business associates and their subcontractors that perform certain services involving the storage, use or disclosure of individually identifiable health information, including mandatory contractual terms, with respect to safeguarding the privacy, security and transmission of individually identifiable health information, and require notification to affected individuals and regulatory authorities of certain breaches of security of individually identifiable health information.
Biggest changeOther federal statutes pertaining to healthcare fraud and abuse include the Civil Monetary Penalties Law statute, which prohibits, among other things, the offer or payment of remuneration to a Medicaid or Medicare beneficiary that the offeror or payor knows or should know is likely to influence the beneficiary to order or receive a reimbursable item or service from a particular supplier, and the additional federal criminal statutes created by the Health Insurance Portability and Accountability Act of 1996 (“HIPAA”), which prohibit, among other things, knowingly and willfully executing or attempting to execute a scheme to defraud any healthcare benefit program or obtain by means of false or fraudulent pretenses, representations or promises any money or property owned by or under the control of any healthcare benefit program in connection with the delivery of or payment for healthcare benefits, items or services.
Aberrant c-Met signaling in cancer cells can occur through a number of mechanisms, including c-Met protein overexpression, MET gene amplification, MET gene or fusion/rearrangement. c-Met Exon-14 Skipping Mutation c-Met Exon-14 gene mutations with functional impact have been found in various domains.
Aberrant c-Met signaling in cancer cells can occur through a number of mechanisms, including c-Met protein overexpression, MET gene amplification, MET gene or fusion/rearrangement. Met Exon 14 Skipping Mutation Met Exon 14 gene mutations with functional impact have been found in various domains.
Among subjects with NSCLC, 3% to 4% have MET Exon-14 skipping mutation, and 3% to 5% have MET amplification on initial presentation while 20% EGFR+ NSCLC subjects manifest with MET over-expression or c-Met amplification when they develop resistance following treatment with targeted therapy using an EGFR inhibitor (TKI).
Among subjects with NSCLC, 3% to 4% have Met Exon 14 skipping mutation, and 3% to 5% have c-Met amplification on initial presentation while 20% EGFR+ NSCLC subjects manifest with c-Met over-expression or c-Met amplification when they develop resistance following treatment with targeted therapy using an EGFR inhibitor (TKI).
NSCLC with MET genomic alteration such as MET Exon-14 skipping, c-Met amplification/over-expression are less responsive to systemic non-targeted therapy typically used for treating NSCLC such as checkpoint inhibitor antibodies, and have worse outcome than NSCLC with MET genomic alterations (Sabari et al., Coactivator Condensation at Super-Enhancers Links Phase Separation and Gene Control, 2018).
NSCLC with c-Met genomic alteration such as Met Exon 14 skipping, c-Met amplification/over- expression are less responsive to systemic non-targeted therapy typically used for treating NSCLC such as checkpoint inhibitor antibodies, and have worse outcome than NSCLC with c-Met genomic alterations (Sabari et al., Coactivator Condensation at Super-Enhancers Links Phase Separation and Gene Control, 2018).
Apollomics is conducting a Phase 1 study, APL-106-01, in Chinese AML subjects. Phase 2 APL-106 studies Uproleselan also has been evaluated in a Phase 1/2 trial in subjects with AML at doses ranging from 5 mg/kg to 20 mg/kg which expanded enrollment at the recommended Phase 2 dose (RP2D) of 10 mg/kg.
Apollomics is conducting a Phase 1 study, APL-106-01, in Chinese AML subjects. Phase 2 uproleselan studies Uproleselan also has been evaluated in a Phase 1/2 trial in subjects with AML at doses ranging from 5 mg/kg to 20 mg/kg which expanded enrollment at the recommended Phase 2 dose (RP2D) of 10 mg/kg.
Discovery-Stage Drug Candidates Our drug discovery platforms enable us to continually broaden our product pipeline in oncology. In addition to our clinical-stage and IND-enabled drug candidates, we are also developing a number of discovery-stage drug candidates, including mono-specific antibodies and bi-specific antibodies.
Discovery-Stage Product Candidates Our drug discovery platforms enable us to continually broaden our product pipeline in oncology. In addition to our clinical-stage and IND-enabled product candidates, we are also developing a number of discovery-stage product candidates, including mono-specific antibodies and bi-specific antibodies.
The Federal Food, Drug, and Cosmetic Act (“FDC Act”) and other federal and state statutes and regulations, govern, among other things, the research, development, testing, manufacture, storage, recordkeeping, approval, labeling, promotion and marketing, distribution, post-approval monitoring and reporting, sampling, and import and export of pharmaceutical products.
The Federal Food, Drug, and Cosmetic Act (the “FDC Act”) and other federal and state statutes and regulations, govern, among other things, the research, development, testing, manufacture, storage, recordkeeping, approval, labeling, promotion and marketing, distribution, post-approval monitoring and reporting, sampling, and import and export of pharmaceutical products.
The enterprise is required to apply for renewal of such permit within six months prior to its expiry and will be subject to reassessment by the issuing authorities in accordance with then prevailing legal and regulatory requirements for the purposes of such renewal.
The enterprise is required to apply for renewal of such permit within six months prior to its expiry and will be subject to reassessment by the issuing authorities in accordance with then prevailing legal and regulatory requirements for the purposes of such renewal.
License and Co-Development Agreement between the Company and TYG Under the TYG License Agreement, which we assumed in connection with the Nuance Transfer Agreement and later amended and restated, TYG granted us a royalty-bearing license under certain licensed technology, including patents and patent applications covering composition of matter and method of use relating to APL-810 (an antigen-specific, active checkpoint-control cancer vaccine) and know-how related to APL-810, to (i) exclusively (even as to TYG) commercialize APL-810 in the TYG Territory; (ii) non-exclusively develop APL-810 in and outside the TYG Territory; and (iii) non-exclusively manufacture APL-810 in and outside the TYG Territory solely for supply to (a) TYG and its affiliates for commercialization outside the TYG Territory; and (b) us with APL-810 for commercialization in the TYG Territory and development in and outside the TYG Territory.
License and Co-Development Agreement between the Company and TYG Under the Underlying TYG License Agreement, which we assumed in connection with the Nuance Transfer Agreement and later amended and restated, TYG granted us a royalty-bearing license under certain licensed technology, including patents and patent applications covering composition of matter and method of use relating to APL-810 (an antigen-specific, active checkpoint-control cancer vaccine) and know-how related to APL-810, to (i) exclusively (even as to TYG) commercialize APL-810 in the TYG Territory; (ii) non-exclusively develop APL-810 in and outside the TYG Territory; and (iii) non-exclusively manufacture APL-810 in and outside the TYG Territory solely for supply to (a) TYG and its affiliates for commercialization outside the TYG Territory; and (b) us with APL-810 for commercialization in the TYG Territory and development in and outside the TYG Territory.
(1) Review and approval procedures for break-through therapeutic drugs In principle, during the drug clinical trials, an applicant may submit the application to the CDE for its drug to be designated as a break-through therapeutic drug if the following general conditions are met: • The drug candidate must be an innovative new drug or improved new drug; • The drug candidate must be used for the prevention and treatment of life-threatening illnesses or illnesses which have a serious impact on the quality of life; and • There is no other effective prevention or treatment method, or there is adequate evidence proving that the drug candidate has obvious clinical advantages over existing treatment methods.
(1) Review and approval procedures for break-through therapeutic drugs In principle, during the drug clinical trials, an applicant may submit the application to the CDE for its drug to be designated as a break-through therapeutic drug if the following general conditions are met: • The product candidate must be an innovative new drug or improved new drug; • The product candidate must be used for the prevention and treatment of life-threatening illnesses or illnesses which have a serious impact on the quality of life; and • There is no other effective prevention or treatment method, or there is adequate evidence proving that the product candidate has obvious clinical advantages over existing treatment methods.
On January 2, 2020, we entered into an exclusive license and collaboration agreement with GlycoMimetics concerning the development and commercialization of uproleselan (APL-106) and a follow-on compound to uproleselan (APL-108) (collectively, the “GlycoMimetics Licensed Products”), i.e., the GlycoMimetics Agreement, for all therapeutic and prophylactic uses in humans (the “GlycoMimetics Licensed Field”) in Greater China.
On January 2, 2020, we entered into an exclusive license and collaboration agreement with GlycoMimetics concerning the development and commercialization of uproleselan and APL-108, a follow-on compound to uproleselan (collectively, the “GlycoMimetics Licensed Products”), i.e., the GlycoMimetics Agreement, for all therapeutic and prophylactic uses in humans (the “GlycoMimetics Licensed Field”) in Greater China.
We can terminate the TYG License Agreement at any time, with or without cause, so long as we provide notice as provided in the TYG License Agreement; however, termination by us would not impact our obligation to effectuate the royalty payments below.
We can terminate the Underlying TYG License Agreement at any time, with or without cause, so long as we provide notice as provided in the Underlying TYG License Agreement; however, termination by us would not impact our obligation to effectuate the royalty payments below.
Permits and licenses for drug manufacturing and commercialization operations Pharmaceutical manufacturing permit and GMP requirements According to the DAL and the DAL Implementing Measures, to manufacture pharmaceutical products in China, a pharmaceutical manufacturing enterprise must first obtain a Pharmaceutical Manufacturing Permit issued by the relevant provincial medical products administration where the enterprise is located.
Permits, licenses and requirements for drug manufacturing and commercialization operations According to the DAL and the DAL Implementing Measures, to manufacture pharmaceutical products in China, a pharmaceutical manufacturing enterprise must first obtain a Pharmaceutical Manufacturing Permit issued by the relevant provincial medical products administration where the enterprise is located.
TYG can also terminate the TYG License Agreement in certain specified circumstances, such as a change of control or in the case of a patent challenge by us, but such termination would not impact the obligation of TYG to effectuate the royalty payments below.
TYG can also terminate the Underlying TYG License Agreement in certain specified circumstances, such as a change of control or in the case of a patent challenge by us, but such termination would not impact the obligation of TYG to effectuate the royalty payments below.
The National Health and Family Planning Commission (“NHFPC”) was rebranded as the NHC in March 2018. The NHC is an authority at the ministerial level under the State Council and is primarily responsible for national public health.
The National Health and Family Planning Commission (“NHFPC”) was rebranded as the NHC (the “NHC”) in March 2018. The NHC is an authority at the ministerial level under the State Council and is primarily responsible for national public health.
In connection with the achievement of delineated regulatory milestones in the TYG License Agreement, Apollomics has agreed to make payments to TYG totaling up to $20,000,000 and up to an aggregate of $85,000,000 in connection with delineated commercial milestones.
In connection with the achievement of delineated regulatory milestones in the Underlying TYG License Agreement, Apollomics has agreed to make payments to TYG totaling up to $20,000,000 and up to an aggregate of $85,000,000 in connection with delineated commercial milestones.
We use both targeted, immuno-oncology, and other innovative approaches to address a range of cancer indications, such as acute myeloid leukemia (“AML”), lung cancer, brain cancer, and other solid tumors.
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.
Recently, we in-licensed from Edison the worldwide rights (excluding China, Hong Kong and Taiwan) of an IND-ready drug candidate, namely APL-122, an ErbB1/2/4 inhibitor; and from Nuance and TYG the Greater China, Taiwan, and South Africa rights of a preclinical-stage cancer vaccine candidate, APL-810. In these arrangements, we typically exchange data with our licensors for development and regulatory purposes.
Recently, we in-licensed from Edison the worldwide rights (excluding China, Hong Kong and Taiwan) of an IND-ready product candidate, namely APL-122, an ErbB1/2/4 inhibitor; and from Nuance and TYG the Greater China, Taiwan, and South Africa rights for a preclinical-stage cancer vaccine candidate, APL-810. In these arrangements, we typically exchange data with our licensors for development and regulatory purposes.
These initiatives recently culminated in the enactment of the IRA in August 2022, which will, among other things, allow HHS to negotiate the selling price of certain drugs and biologics that CMS reimburses under Medicare Part B and Part D, although this will only apply to high-expenditure single-source drugs that have been approved for at least 7 years (11 years for biologics).
These initiatives recently culminated in the enactment of the IRA in August 2022, which will, among other things, allow HHS to negotiate the selling price of certain drugs and biologics that CMS reimburses under Medicare Part B and Part D, although this will only apply to high-expenditure single-source drugs that have been approved for at least seven years (11 years for biologics).
Subject to the terms of the CDA, we are precluded from disclosing more information about the nature of the transaction to any third party unless required by “a court or administrative subpoena or order.” Despite the foregoing, we cannot assure you that we will be able to obtain the license in time or on commercially acceptable terms, and if we fail to do so, we may need to delay our launch in the relevant markets until the Structure Patents expire in December 2026, or if we plan to commercialize APL-101 as scheduled, we face the risk that the relevant third party may initiate legal proceedings against us.
Subject to the terms of the CDA, we are precluded from disclosing more information about the nature of the transaction to any third party unless required by “a court or administrative subpoena or order.” Despite the foregoing, we cannot assure you that we will be able to obtain the license in time or on commercially acceptable terms, and if we fail to do so, we may need to delay our launch in the relevant markets until the Structure Patents expire in December 2026, or if we plan to commercialize vebreltinib as scheduled, we face the risk that the relevant third party may initiate legal proceedings against us.
If and when APL-106 or APL-108 is approved for marketing in Greater China, we plan to continue to procure APL-106 or to procure APL-108 from GlycoMimetics or its third-party partners to support our initial commercialization in Greater China under the supply agreements to be entered into between us and GlycoMimetics, and only thereafter may manufacture APL-106 or APL-108 via our own CMOs under the manufacturing license granted by GlycoMimetics in the GlycoMimetics Agreement.
If and when uproleselan or APL-108 is approved for marketing in Greater China, we plan to continue to procure uproleselan or to procure APL-108 from GlycoMimetics or its third-party partners to support our initial commercialization in Greater China under the supply agreements to be entered into between us and GlycoMimetics, and only thereafter may manufacture uproleselan or APL-108 via our own CMOs under the manufacturing license granted by GlycoMimetics in the GlycoMimetics Agreement.
According to the databases of the relevant patent offices, GlycoMimetics is the sole and exclusive owner of the licensed patent applications related to APL-108. APL-108 is an innovative, rationally designed E-Selectin antagonist which is suitable for subcutaneous administration and has been shown to have equivalent activity to APL-106 in preclinical studies, but at an approximately 1,000-fold lower dose.
According to the databases of the relevant patent offices, GlycoMimetics is the sole and exclusive owner of the licensed patent applications related to APL-108. APL-108 is an innovative, rationally designed E-Selectin antagonist which is suitable for subcutaneous administration and has been shown to have equivalent activity to uproleselan in preclinical studies, but at an approximately 1,000-fold lower dose.
Leveraging our external resources, we have adopted a biomarker-driven diagnostic approach for patient screening to identify patients with specific biomarkers who could potentially be responsive to a study drug that can potentially benefit from our programs. Since our inception, we have assembled an experienced management team and have recruited industry talents with track records.
Leveraging our external resources, we have adopted a biomarker-driven diagnostic approach for patient screening to identify patients with specific biomarkers who could potentially be responsive to a study drug that can potentially benefit from our programs. Since our inception, we have assembled an experienced management team and have recruited industry talents with track records of success.
APL-106 Uproleselan at doses ranging from 5-20 mg/kg was well tolerated with a safety profile similar to background chemotherapy. There was lower than expected rates of severe, debilitating Grade 3-4 mucositis reported (e.g., 3% incidence reported vs. historical 20-25% incidence with MEC alone). The addition of uproleselan was associated with low rates of oral mucositis.
Uproleselan at doses ranging from 5–20 mg/kg was well tolerated with a safety profile similar to background chemotherapy. There was lower than expected rates of severe, debilitating Grade 3–4 mucositis reported (e.g., 3% incidence reported vs. historical 20–25% incidence with MEC alone). The addition of uproleselan was associated with low rates of oral mucositis.
We have built a network of over 100 centers for clinical trials across more than ten jurisdictions, including the United States, China, Canada, England, France, Spain, Germany, Italy, Australia, Taiwan and Singapore, as well as lead sites at leading academic medical institutions, including the Dana-Farber Cancer Institute.
We have built a network of over 100 centers for clinical trials across more than ten jurisdictions, including the United States, China, Canada, England, France, Spain, Germany, Italy, Australia, Taiwan and Singapore, including lead sites at leading academic medical institutions, such as the Dana-Farber Cancer Institute.
SAE Results from APL-106 Phase 2 Studies Dose Level of Uproleselan SAEs Reported Any level plus MEC 32 RP2D uproleselan 10 mg/kg plus MEC 24 Uproleselan 10 mg/kg plus 7+3 (erythema multiforme) 16 Two SAEs reported in subjects who received uproleselan plus MEC (enterocolitis and sepsis) and one SAE in a subject treated with uproleselan plus 7+3 (erythema multiforme) were assessed to be related to uproleselan.
SAE Results from Uproleselan Phase 2 Studies Dose Level of Uproleselan SAEs Reported Any level plus MEC 32 RP2D uproleselan 10 mg/kg plus MEC 24 Uproleselan 10 mg/kg plus 7+3 (erythema multiforme) 16 Two SAEs reported in subjects who received uproleselan plus MEC (enterocolitis and sepsis) and one SAE in a subject treated with uproleselan plus 7+3 (erythema multiforme) were assessed to be related to uproleselan.
Agreements with Nuance Group and TYG Related to APL-810 Technology Transfer and Co-Development Agreement between the Company and Nuance Group On January 25, 2021, we entered into a technology transfer and co-development agreement (i.e., the Nuance Transfer Agreement) with Nuance Group concerning (i) the assignment of the license and co-development agreement between TYG and Nuance dated October 19, 2018 (the “Underlying TYG License Agreement”) by Nuance to us; and (ii) the transfer of certain assets relating to the Underlying TYG License Agreement by Nuance Group to us.
Agreements with Nuance Group and TYG Related to APL-810 Technology Transfer and Co-Development Agreement between the Company and Nuance Group On January 25, 2021, we entered into a technology transfer and co-development agreement (the “Nuance Transfer Agreement”) with Nuance Group concerning (i) the assignment of the license and co-development agreement between TYG and Nuance dated October 19, 2018 (the “Underlying TYG License Agreement”) by Nuance to us; and (ii) the transfer of certain assets relating to the Underlying TYG License Agreement by Nuance Group to us.
Any drug candidates that we successfully develop and commercialize would compete with existing drugs and new drugs that may become available in the future. We operate in the segments of the pharmaceutical, biopharmaceutical and other related markets that address oncology diseases. There are many other companies spread across the world working to develop similar therapies in these fields.
Any product candidates that we successfully develop and commercialize would compete with existing drugs and new drugs that may become available in the future. We operate in the segments of the pharmaceutical, biopharmaceutical and other related markets that address oncology diseases. There are many other companies spread across the world working to develop similar therapies in these fields.
On November 27, 2020, the China National Intellectual Property Administration (CNIPA) published the Proposed Amendments to Implementing Rules of the Patent Law of the PRC for public comments, proposing detailed implementation rules for patent term extension and adjustment, including but without limitation, the eligible type of patents, requirements for the application for patent term extension and adjustment, calculation method of the extension, and limitations during the extended patent term.
On November 27, 2020, the China National Intellectual Property Administration (“CNIPA”) published the Proposed Amendments to Implementing Rules of the Patent Law of the PRC for public comments, proposing detailed implementation rules for patent term extension and adjustment, including but without limitation, the eligible type of patents, requirements for the application for patent term extension and adjustment, calculation method of the extension, and limitations during the extended patent term.
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. 158 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. 96 Table of Contents After a device is placed on the market, it remains subject to significant regulatory requirements.
Recently, gene fusions have served as specific targets for treatment, resulting in dramatically improved patient outcomes with multiple other gene fusion targets under investigation.
Gene fusions have served as specific targets for treatment, resulting in dramatically improved patient outcomes with multiple other gene fusion targets under investigation.
Pursuant to the Nuance Transfer Agreement, we are not required to make any milestone payment directly to TYG. 138 Table of Contents Under the Nuance Transfer Agreement, Nuance Group agrees to use commercially reasonable efforts to cause TYG to grant to us a right of first negotiation for us to obtain TYG200 and Active Checkpoint Control Immunotherapy technology.
Pursuant to the Nuance Transfer Agreement, we are not required to make any milestone payment directly to TYG. 81 Table of Contents Under the Nuance Transfer Agreement, Nuance Group agrees to use commercially reasonable efforts to cause TYG to grant to us a right of first negotiation for us to obtain TYG200 and Active Checkpoint Control Immunotherapy technology.
Even if the patent term of any of the Structure Patents, the General Method Patent and the issued patents with respect to the Withdrawn Method Patent Application (if granted) is extended, such extension would not affect our clinical development plan and commercial launch of APL-101 as APL-101 is not a generic version of any approved drug and we do not anticipate that APL-101 will be a generic version of any drug to be approved. • The existence of the Structure Patents, the General Method Patent, the Withdrawn Method Patent Application and the key patents of the approved c-Met inhibitors does not have any impact on the validity and enforceability of our issued patents in relation to APL-101 because of the allowance of claims in our issued patents by the relevant patent offices.
Even if the patent term of any of the Structure Patents, the General Method Patent and the issued patents with respect to the Withdrawn Method Patent Application (if granted) is extended, such extension would not affect our clinical development plan and commercial launch of vebreltinib as vebreltinib is not a generic version of any approved drug and we do not anticipate that vebreltinib will be a generic version of any drug to be approved. • The existence of the Structure Patents, the General Method Patent, the Withdrawn Method Patent Application and the key patents of the approved c-Met inhibitors does not have any impact on the validity and enforceability of our issued patents in relation to vebreltinib because of the allowance of claims in our issued patents by the relevant patent offices.
The key competitive factors affecting the success of all of our drug candidates, if approved, are likely to be their efficacy, safety, convenience and price, the effectiveness of companion diagnostics in guiding the use of related therapeutics, the level of generic competition, and the availability of reimbursement from government and other third-party payors.
The key competitive factors affecting the success of all of our product candidates, if approved, are likely to be their efficacy, safety, convenience and price, the effectiveness of companion diagnostics in guiding the use of related therapeutics, the level of generic competition, and the availability of reimbursement from government and other third-party payors.
Under the MAH System, domestic drug research and development institutions and individuals in the piloted regions are eligible to be holders of drug marketing authorizations without having to become drug manufacturers. The Pilot Plan was originally set for a 3-year period by the SCNPC and would end in November 2018.
Under the MAH System, domestic drug research and development institutions and individuals in the piloted regions are eligible to be holders of drug marketing authorizations without having to become drug manufacturers. The Pilot Plan was originally set for a three-year period by the SCNPC and would end in November 2018.
Capmatinib, a single-targeted c-Met inhibitor, was originally granted accelerated approval by the FDA in 2020 and has been adopted for the treatment of NSCLC patients with MET Exon-14 skipping mutation in the first-line and subsequent treatments in the United States. The FDA granted full approval to capmatinib in August 2022.
Capmatinib, a single-targeted c-Met inhibitor, was originally granted accelerated approval by the FDA in 2020 and has been adopted for the treatment of NSCLC patients with Met Exon 14 skipping mutation in the first-line and subsequent treatments in the United States. The FDA granted traditional approval to capmatinib in August 2022.
Based on the results of such freedom to operate analysis and the fact that our targeted indications for APL-101 are certain cancers with c-Met dysregulation, we believe that the indications which APL-101 will be marketed for will not literally fall within the scope of the claims presently on file, meaning that our action in the intended use of APL-101 (i.e., therapeutic use in certain cancer patients with c-Met dysregulation) does not involve exactly each and every element recited in the claims of the Withdrawn Method Patent Application.
Based on the results of such freedom to operate analysis and the fact that our targeted indications for vebreltinib are certain cancers with c-Met dysregulation, we believe that the indications which vebreltinib will be marketed for will not literally fall within the scope of the claims presently on file, meaning that our action in the intended use of vebreltinib (i.e., therapeutic use in certain cancer patients with c-Met dysregulation) does not involve exactly each and every element recited in the claims of the Withdrawn Method Patent Application.
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.
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.
We believe our knowledge in target discovery, cancer biology and antibody generation and development, as well as our protein engineering capabilities and global clinical development capabilities will maximize the probability of high quality drug candidates to grow our pipeline to be followed by technical and regulatory success of our in-house discovered drug candidates.
We believe our knowledge in target discovery, cancer biology and antibody generation and development, as well as our protein engineering capabilities and global clinical development capabilities will maximize the probability of high quality product candidates to grow our pipeline to be followed by technical and regulatory success of our in-house discovered product candidates.
Further, we are also developing several mono-specific and bi-specific antibodies targeting cancer-associated myeloid and lymphoid cells. These drug candidates are all in early discovery-stage and have no available clinical data for proof of concept. APL-801 is a representative program.
Further, we are also developing several mono-specific and bi-specific antibodies targeting cancer-associated myeloid and lymphoid cells. These product candidates are all in early discovery-stage and have no available clinical data for proof of concept. APL-801 is a representative program.
With respect to APL-106, the triggering events of development and regulatory milestone payments are (1) the NMPA’s agreement on either a (i) parallel database study or (ii) separate bridging study, in either case involving less than 100 Chinese subjects in total to support regulatory of a GlycoMimetics Licensed Product in Greater China; (2) regulatory subjects of a GlycoMimetics Licensed Product for acute myeloid leukemia in Greater China; (3) initiation of each pivotal trial for each of the first three indications (excluding acute myeloid leukemia) in Greater China; and (4) regulatory approval of a GlycoMimetics Licensed Product for each of the first three indications (excluding acute myeloid leukemia) in Greater China.
With respect to uproleselan, the triggering events of development and regulatory milestone payments are (1) the NMPA’s agreement on either a (i) parallel database study or (ii) separate bridging study, in either case involving less than 100 Chinese subjects in total to support regulatory of a GlycoMimetics Licensed Product in Greater China; (2) regulatory subjects of a GlycoMimetics Licensed Product for acute myeloid leukemia in Greater China; (3) initiation of each pivotal trial for each of the first three indications (excluding acute myeloid leukemia) in Greater China; and (4) regulatory approval of a GlycoMimetics Licensed Product for each of the first three indications (excluding acute myeloid leukemia) in Greater China.
Pursuant to the Caris MSA, we will provide subject samples to Caris and Caris will use commercially reasonable efforts to perform certain services, including preparing an analytically validated assay which may be used to select subjects in clinical trials of APL-101 in NSCLC and pan-cancer indications, conducting analytical verification and validation studies and a diagnostic clinical trial required for regulatory approval, and seeking product approval and/or registration with global regulatory authorities.
Pursuant to the Caris MSA, we will provide subject samples to Caris and Caris will use commercially reasonable efforts to perform certain services, including preparing an analytically validated assay which may be used to select subjects in clinical trials of vebreltinib in NSCLC and pan-cancer indications, conducting analytical verification and validation studies and a diagnostic clinical trial required for regulatory approval, and seeking product approval and/or registration with global regulatory authorities.
There is no approved targeted therapy for treatment of GMB with MET dysregulation. New treatments are urgently needed.
There is no approved targeted therapy for treatment of GMB with c-Met dysregulation. New treatments are urgently needed.
Phase 1 APL-106 studies GlycoMimetics has evaluated uproleselan in three Phase 1 trials in healthy volunteers at doses ranging from 2 mg/kg to 40 mg/kg, and a number of clinical pharmacology studies. In addition, uproleselan has been evaluated in multiple-dose, Phase 1 trials (one in subjects with MM and one in subjects with DVT).
Phase 1 uproleselan studies GlycoMimetics has evaluated uproleselan in three Phase 1 trials in healthy volunteers at doses ranging from 2 mg/kg to 40 mg/kg, and a number of clinical pharmacology studies. In addition, uproleselan has been evaluated in multiple-dose, Phase 1 trials (one in subjects with MM and one in subjects with DVT).
While we believe that our expertise, scientific knowledge and drug candidates developed so far provide us with competitive advantages, we face potential competition from many known and unknown entities, including existing and new biopharmaceutical companies, academic institutions and public and private research institutions.
While we believe that our expertise, scientific knowledge and product candidates developed so far provide us with competitive advantages, we face potential competition from many known and unknown entities, including existing and new biopharmaceutical companies, academic institutions and public and private research institutions.
Manufacturing Our CMC team works closely with our collaboration partners and CMOs to ensure supply of high quality materials for preclinical and clinical development of our drug candidates. With our experienced CMC team and knowledge in CMC of small molecules and biologics, we are able to advance drug candidates through the development cycle.
Manufacturing Our CMC team works closely with our collaboration partners and CMOs to ensure supply of high quality materials for preclinical and clinical development of our product candidates. With our experienced CMC team and knowledge in CMC of small molecules and biologics, we are able to advance product candidates through the development cycle.
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.
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.
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.
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.
With respect to the rights for APL-101 in China, Hong Kong and Macau, Crown Bioscience (Taicang) and Pearl entered into an exclusive license agreement on November 7, 2012 (the “Pearl Agreement”), pursuant to which Crown Bioscience (Taicang) granted to Pearl an exclusive license under certain intellectual property rights to develop and commercialize APL-101 in China, Hong Kong and Macau (the “Pearl Territory”), and Pearl granted to Crown Bioscience (Taicang) the right to use the intellectual property related to APL-101 and generated by or on behalf of Pearl in the Pearl Territory for patent applications, clinical development and commercialization of APL-101 outside the Pearl Territory.
With respect to the rights for vebreltinib in China, Hong Kong and Macau, Crown Bioscience (Taicang) and Pearl entered into an exclusive license agreement on November 7, 2012 (the “Pearl Agreement”), pursuant to which Crown Bioscience (Taicang) granted to Pearl an exclusive license under certain intellectual property rights to develop and commercialize vebreltinib in China, Hong Kong and Macau (the “Pearl Territory”), and Pearl granted to Crown Bioscience (Taicang) the right to use the intellectual property related to vebreltinib and generated by or on behalf of Pearl in the Pearl Territory for patent applications, clinical development and commercialization of vebreltinib outside the Pearl Territory.
As some of our drug candidates approach commercialization, we plan to seek strategic partnerships with recognized players in the industry to make our innovative medicines accessible to patients, and to maximize the market potential of our assets in the most efficient manner. • Accelerating the clinical development of our drug candidates.
As some of our product candidates approach commercialization, we plan to seek strategic partnerships with recognized players in the industry to make our innovative medicines accessible to patients, and to maximize the market potential of our assets in the most efficient manner. • Accelerating the clinical development of our product candidates .
We have obtained an exclusive license globally (excluding China, Hong Kong and Taiwan) under a group of patents and patent applications related to APL-122, including 14 issued patents. • APL-106 and APL-108 . We did not own any issued patent or patent application directed to APL-106 and/or APL-108.
We have obtained an exclusive license globally (excluding China, Hong Kong and Taiwan) under a group of patents and patent applications related to APL-122, including 14 issued patents. • Uproleselan and APL-108 . We did not own any issued patent or patent application directed to uproleselan and/or APL-108.
Applications under the BPCA are treated as priority applications. 154 Table of Contents Additional Controls for Biologics To help reduce the increased risk of the introduction of adventitious agents, the PHS Act emphasizes the importance of manufacturing controls for products whose attributes cannot be precisely defined.
Applications under the BPCA are treated as priority applications. 93 Table of Contents Additional Controls for Biologics To help reduce the increased risk of the introduction of adventitious agents, the PHS Act emphasizes the importance of manufacturing controls for products whose attributes cannot be precisely defined.
Given that APL-102 inhibits several kinases that are aberrantly activated in cancer cells, we believe that APL-102 has the potential to overcome cancer treatment resistance. APL-102 is in a Phase 1 dose escalation clinical trial in China and is at the fourth dose level.
Given that APL-102 inhibits several kinases that are aberrantly activated in cancer cells, we believe that APL-102 has the potential to overcome cancer treatment resistance. APL-102 is in a Phase 1 dose escalation clinical trial in China and is at the seventh dose level.
For more information regarding our arrangements with third parties, please see the section below entitled “Licensing and Collaboration Arrangements.” Our Strategy Our strategic focus is the development of novel therapies targeting difficult to treat cancers and drug resistant patients.
For more information regarding our arrangements with third parties, please see the section below entitled “ Licensing and Collaboration Arrangements .” Our Strategy Our strategic focus is the development of novel therapies targeting difficult to treat cancers and drug resistant patients.
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. 111 Table of Contents 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 Note: (1) c-Met activation induces biological responses via activation of various intracellular signaling pathways.
Investigator Sponsored Studies (ISTs) Investigator sponsored studies of APL-106 include: • Phase 2 trial sponsored by Washington University School of Medicine is enrolling subjects undergoing first autologous hematopoietic cell transplantation (Auto-HCT) for MM; • Phase 1b/2 trial sponsored by MD Anderson Cancer Center is evaluating subjects with treated secondary AML; and • Phase 1 trial sponsored by UC Davis Comprehensive Cancer Center to enroll older or unfit subjects with treatment-naïve AML.
Investigator Sponsored Studies (ISTs) Investigator sponsored studies of uproleselan include: • Phase 2 trial sponsored by Washington University School of Medicine is enrolling subjects undergoing first autologous hematopoietic cell transplantation (Auto-HCT) for MM; • Phase 1b/2 trial sponsored by MD Anderson Cancer Center is evaluating subjects with treated secondary AML; and • Phase 1 trial sponsored by UC Davis Comprehensive Cancer Center to enroll older or unfit subjects with treatment-naïve AML.
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.
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.
Signals of potential durable (> 2 years) efficacy (by achieving partial response) was first observed in a subject with recurrent metastatic Schwannoma with c-Met expression as well as in a subject with recurrent GBM with c-Met amplification previously treated with Temolar, Avastin and Nivolumab.
Signals of potential durable (> 2 years) efficacy (by achieving partial response) was first observed in a subject with recurrent metastatic Schwannoma with c-Met expression as well as in a subject with recurrent GBM with c-Met amplification previously treated with Temodar, Avastin and Nivolumab.
We have obtained an exclusive license in Greater China, Taiwan, and South Africa under a group of patents and patent applications related to APL-810, including six issued patents and one pending patent applications. • APL-801 . We have one patent application pending in the United States.
We have obtained an exclusive license in Greater China, Taiwan, and South Africa under a group of patents and patent applications related to APL-810, including five issued patents and one pending patent applications. • APL-801 . We have one patent application pending in the United States.
GlycoMimetics has received several designations for APL-106 from regulatory authorities outside Greater China, including (i) orphan drug designations for the treatment of patients with AML granted by the FDA and EMA in May 2015 and May 2017, respectively, (ii) fast track designation for the treatment of adult patients with r/r AML and elderly patients aged 60 years or older with AML granted by the FDA in June 2016, and (iii) breakthrough therapy designation for the treatment of adult patients with r/r AML granted by the FDA in May 2017.
GlycoMimetics has received several designations for uproleselan from regulatory authorities outside Greater China, including (i) orphan drug designations for the treatment of patients with AML granted by the FDA and EMA in May 2015 and May 2017, respectively, (ii) fast track designation for the treatment of adult patients with r/r AML and elderly patients aged 60 years or older with AML granted by the FDA in June 2016, and (iii) breakthrough therapy designation for the treatment of adult patients with r/r AML granted by the FDA in May 2017.
Considering the limited patent term remaining, the costly and time-consuming litigation or other proceedings, as well as the Patent Holder Group’s potential interest in a business transaction with us, we believe it is unlikely that the Patent Holder Group will bring claims for infringement or even seek injunction against us after we obtain the regulatory approval of APL-101 in relevant jurisdictions.
Considering the limited patent term remaining, the costly and time-consuming litigation or other proceedings, as well as the Patent Holder Group’s potential interest in a business transaction with us, we believe it is unlikely that the Patent Holder Group will bring claims for infringement or even seek injunction against us after we obtain the regulatory approval of vebreltinib in relevant jurisdictions.
APL-106 and APL-108 are designed to block E-selectin from binding with blood cancer cells as a novel approach to disrupting well-established mechanisms of leukemic cell resistance within the bone marrow microenvironment. APL-106 .
Uproleselan and APL-108 are designed to block E-selectin from binding with blood cancer cells as a novel approach to disrupting well-established mechanisms of leukemic cell resistance within the bone marrow microenvironment. Uproleselan .
According to the CIC Report, global (excluding China) incidence of NSCLC was 1.0 million cases in 2019 and is expected to expand to 1.3 million by 2030. In the United States, the incidence of NSCLC was approximately 178,300 cases in 2019 and is expected to reach approximately 221,200 in 2030.
According to the CIC Report, global (excluding China) incidence of NSCLC was 1.0 million cases in 2019 and is expected to increase to 1.3 million by 2030. In the United States, the incidence of NSCLC was approximately 178,300 cases in 2019 and is expected to reach approximately 221,200 in 2030.
As supported by studies in animal models, we consider that APL-106 has the potential to possibly improve chemotherapy response rates, duration of remission and, ultimately, survival in patients with hematologic cancers such as AML. Preclinical study results APL-106 data included elsewhere in this Annual Report shows mobilization of AML cancer cells out of the bone marrow in mouse models.
As supported by studies in animal models, we consider that uproleselan has the potential to possibly improve chemotherapy response rates, duration of remission and, ultimately, survival in patients with hematologic cancers such as AML. Preclinical study results Uproleselan data included elsewhere in this Annual Report shows mobilization of AML cancer cells out of the bone marrow in mouse models.
A third-party patent application in Europe claiming the use of a c-Met antagonist for treating glioblastoma expressing high level of HGF, which we refer to as the Withdrawn Method Patent Application, is currently deemed to be withdrawn.
A third-party patent application in Europe claiming the use of a c-Met antagonist for treating glioblastoma expressing high level of HGF, which we refer to as the Withdrawn Method Patent Application (the “Withdrawn Method Patent Application”), is currently deemed to be withdrawn.
Our future commercial success depends, in part, on our ability to obtain and maintain patent and other intellectual property and proprietary protections for commercially important technologies, inventions and know-how related to our business, defend and enforce our patents, preserve the confidentiality of our trade secrets, and operate without infringing, misappropriating or otherwise violating the valid, enforceable intellectual property rights of third parties.
Our future commercial success depends, in part, on our ability to obtain and maintain patent protection and other intellectual property for commercially important technologies, inventions and know-how related to our business, defend and enforce our patents, preserve the confidentiality of our trade secrets, and operate without infringing, misappropriating or otherwise violating the valid, enforceable intellectual property rights of third parties.
Each of the foregoing milestone payments shall be payable only one time for APL-106 or APL-108 in a GlycoMimetics Licensed Product for each indication (i.e., a milestone payment shall be payable only one time, if only the formulation changes but the indication is the same).
Each of the foregoing milestone payments shall be payable only one time for uproleselan or APL-108 in a GlycoMimetics Licensed Product for each indication (i.e., a milestone payment shall be payable only one time, if only the formulation changes but the indication is the same).
In China, the Standing Committee of the National People’s Congress (SCNPC) promulgated the amended Patent Law of the PRC in October 2020, which became effective on June 1, 2021 and provides for patent term adjustment and patent term extension for the first time.
In China, the Standing Committee of the National People’s Congress (“SCNPC”) promulgated the amended Patent Law of the PRC in October 2020, which became effective on June 1, 2021 and provides for patent term adjustment and patent term extension for the first time.
Each of the parties’ obligations to pay royalties will expire, on a country-by-country basis with respect to each separate product, on the later of the First Commercial Sale (as defined in the TYG Agreement) of a given product in such country and the time at which there is no longer a Valid Claim (as defined in the TYG Agreement) of a party’s patent rights that claim or cover the Commercialisation (as defined in the TYG Agreement) of such product.
Each of the parties’ obligations to pay royalties will expire, on a country-by-country basis with respect to each separate product, on the later of the First Commercial Sale (as defined in the Underlying TYG Agreement) of a given product in such country and the time at which there is no longer a Valid Claim (as defined in the Underlying TYG Agreement) of a party’s patent rights that claim or cover the Commercialization (as defined in the Underlying TYG Agreement) of such product.
All animals responded with detectable antibody at day 14, high titres at day 29, peaking at day 42, to human G17 and gly-G17 with no signs of local or systemic reaction. We in-licensed APL-810 from TYG and Nuance for development and commercialization in Greater China, Taiwan, and South Africa, and in the United States.
All animals responded with detectable antibody at day 14, high titres at day 29, peaking at day 42, to human G17 and gly-G17 with no signs of local or systemic reaction. 76 Table of Contents We in-licensed APL-810 from TYG and Nuance for development and commercialization in Greater China, Taiwan, and South Africa, and in the United States.
We conduct our business under the brand name of “Apollomics.” As of the date of this Annual Report, we had primarily registered 14 trademarks/classes in China, 2 trademarks/classes in the United States, and 24 trademarks/classes in Hong Kong.
We conduct our business under the brand name of “Apollomics.” As of the date of this Annual Report, we had primarily registered 14 trademarks/classes in China, two trademarks/classes in the United States, and 24 trademarks/classes in Hong Kong.
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. 156 Table of Contents 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 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.
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 APL-101. 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 requirements and study endpoints.
CTTQ has the rights to APL-502, also known as TQB-2450, in China, while we have the rights to APL-502 in the rest of the world (please refer to “— Intellectual Property Assignment” above for further details).
CTTQ has the rights to APL-502, also known as TQB-2450, in China, while we have the rights to APL-502 in the rest of the world (please refer to “ Intellectual Property Assignment ” above for further details).
For further information, please refer to the table summarizing the details of the issued patents and the filed patent applications owned by us on APL-101, APL-501, APL-502 and APL-102 above in this section.
For further information, please refer to the table summarizing the details of the issued patents and the filed patent applications owned by us on vebreltinib, APL-501, APL-502 and APL-102 above in this section.
APL-101 also inhibited the proliferation and survival of c-Met-dependent cancer cells, including cancer cell growth driven by specific c-Met mutations or amplification. Lastly, APL-101 demonstrated anti-tumor activity against patient-derived human lung cancer xenografts with either c-MET Exon-14 skipping mutations, c-Met amplifications, or c-Met fusion implanted into nude mice.
Vebreltinib also inhibited the proliferation and survival of c-Met-dependent cancer cells, including cancer cell growth driven by specific c-Met mutations or amplification. Lastly, vebreltinib demonstrated anti-tumor activity against patient-derived human lung cancer xenografts with either Met Exon 14 skipping mutations, c-Met amplifications, or c-Met fusion implanted into nude mice.
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.
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.
These drug candidates are designed to take advantage of the body’s immune system to fight cancer and include mono-specific and bi-specific antibodies that could release the natural brakes of immune response against cancer cells, as well as a novel cancer vaccine. APL-501 . APL-501 is an anti-PD-1 antibody drug candidate.
These product candidates are designed to take advantage of the body’s immune system to fight cancer and include mono-specific and bi-specific antibodies that could release the natural brakes of immune response against cancer cells, as well as a novel cancer vaccine. APL-501 . APL-501 is an anti-PD-1 antibody product candidate. APL-502 .
The concentration in CSF was about 5% of the steady-state plasma. 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. 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.
For a drug candidate that has received the NMPA’s breakthrough therapy designation, the NMPA will give priority in its review process and provide additional guidance on regulatory development of such drug candidate.
For a product candidate that has received the NMPA’s breakthrough therapy designation, the NMPA will give priority in its review process and provide additional guidance on regulatory development of such product candidate.

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Biggest changeThe following table presents Apollomics’ consolidated statements of profit or loss and other comprehensive loss data for the years ended December 31, 2020, 2021 and 2022: Years ended December 31, (In thousands of USD $, except percentages) 2020 2021 2022 Other income $ 2,060 $ 1,054 $ 1,447 Other gains and losses 144 36 (829 ) Fair value change of financial assets at fair value through profit or loss (“FVTPL”) 108 2 323 Fair value change of convertible preferred shares (26,572 ) (37,424 ) (189,646 ) Research and development expenses (31,441 ) (35,568 ) (35,457 ) Administrative expenses (11,043 ) (15,291 ) (9,947 ) Impairment loss of an intangible asset (1,000 ) (3,000 ) — Issuance costs for convertible preferred shares (3,782 ) — — Finance costs (72 ) (83 ) (93 ) Other expense (3,307 ) (4,522 ) (6,608 ) Loss before taxation (74,905 ) (94,796 ) (240,810 ) Income tax credit (expense) 85 (1 ) (1 ) Loss and total comprehensive expenses for the year, attributable to owners of the Company $ (74,820 ) $ (94,797 ) $ (240,811 ) 180 Table of Contents Year Ended December 31, 2022 Compared to Year Ended December 31, 2021 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, Change (In thousands of USD $, except percentages) 2021 2022 $ % Interest income $ 467 $ 431 $ (36 ) (7.7% ) Government grants 587 1,016 429 73% Total $ 1,054 $ 1,447 $ 393 37.3% 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.
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.
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.
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.
Our pipeline includes a variety of cancer treatment programs that utilize tumor inhibitors, cell adhesion inhibitors, immune checkpoint inhibitors, a cancer vaccine, 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 response rates and reduce chemo-resistance and toxicity compared to the current treatment standards.
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 market fund in the U.S. which solely holds investments in U.S. treasury bonds.
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.
The amount initially recognized for internally-generated intangible asset is the sum of the expenditure incurred from the date when the intangible asset first meets the recognition criteria listed above. Where no internally generated intangible asset can be recognized, development expenditure is recognized in profit or loss in the period in which it is incurred.
The amount initially recognized for an internally generated intangible asset is the sum of the expenditure incurred from the date when the intangible asset first meets the recognition criteria listed above. Where no internally generated intangible asset can be recognized, development expenditure is recognized in profit or loss in the period in which it is incurred.
We do not assign or allocate internal costs such as salaries and benefits, facilities costs, lab supplies and the costs of preclinical research and studies to individual development programs. Research and development activities are central to our business model.
We do not assign or allocate internal costs such as salaries and benefits, facilities costs, lab supplies and the costs of preclinical research and studies to individual development programs. Research and development activities are central to our business.
We expect to continue to generate operating losses and negative operating cash flows for the foreseeable future if and as we: • continue the research and development of our product candidates; • seek regulatory and marketing authorization for any of our product candidates that successfully complete development; • seek to identify and validate additional product candidates; • acquire or license other product candidates, technologies, or biological materials; • make milestone, royalty, or other payments under any current or future license agreements; • obtain, maintain, protect, and enforce our intellectual property portfolio; 176 Table of Contents • seek to attract and retain new and existing skilled personnel; • create additional infrastructure to support our operations as a public company and incur increased legal, accounting, investor relations and other expenses; and • experience delays or encounter issues with any of the above.
We expect to continue to generate operating losses and negative operating cash flows for the foreseeable future if and as we: • continue the research and development of our product candidates; • seek regulatory and marketing authorization for any of our product candidates that successfully complete development; • seek to identify and validate additional product candidates; • acquire or license other product candidates, technologies, or biological materials; • make milestone, royalty, or other payments under any current or future license agreements; • obtain, maintain, protect, and enforce our intellectual property portfolio; • seek to attract and retain new and existing skilled personnel; • create additional infrastructure to support our operations as a public company and incur increased legal, accounting, investor relations and other expenses; and • experience delays or encounter issues with any of the above.
In the application of our accounting policies, our directors are required to make judgments, estimates and assumptions about the carrying amounts of assets and liabilities that are not readily apparent from other sources. The estimates and underlying assumptions are based on historical experience and other factors that are considered to be relevant. Our actual results may differ from these estimates.
In the application of our accounting policies, we are required to make judgments, estimates and assumptions about the carrying amounts of assets and liabilities that are not readily apparent from other sources. The estimates and underlying assumptions are based on historical experience and other factors that are considered to be relevant. Our actual results may differ from these estimates.
On the lease commencement, we recognized $0.3 million and $53 thousand of right-of-use asset and lease liabilities, respectively. During the year ended December 31, 2022, we entered into new lease agreements for the use of offices, and plant and equipment for 12 months to 60 months (about 5 years).
On the lease commencement, we recognized $0.3 million and $53 thousand of right-of-use asset and lease liabilities, respectively. During the year ended December 31, 2022, we entered into new lease agreements for the use of offices, and plant and equipment for 12 months to 60 months (about five years).
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 (In thousands of USD $, except percentages) 2021 2022 $ % Administrative Employee Other Compensation 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% ) 182 Table of Contents 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, 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.
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.
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.
Save as disclosed below, we did not hedge or consider it necessary to hedge any of these risks. B. Liquidity and Capital 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.
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.
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. 177 Table of Contents Other Gains and Losses Other gains and losses primarily consist of foreign exchange gains and losses as a result of foreign exchange rate fluctuation.
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.
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 8 new R&D employees in 2022. We manage our R&D third-party service fees and our contractor expenses by product, which is shown in the table above.
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.
For the years ended December 31, 2021 and 2022, the fair value change of financial assets at fair value through profit or loss was a $2 thousand increase and a $323 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.
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.
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 ordinary shares that are held by nonaffiliates 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.
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
If we do raise additional capital through public or private equity or convertible debt offerings, the ownership interest of our existing stockholders will be diluted, and the terms of these securities may include liquidation or other preferences that adversely affect our stockholders’ rights.
If we do raise additional capital through public or private equity or convertible debt offerings, the ownership interest of our existing shareholders will be diluted, and the terms of these securities may include liquidation or other preferences that adversely affect our shareholders’ rights.
Please refer to notes 4 and 5 to our audited consolidated financial statements included elsewhere in this Annual Report for more details about our significant accounting policies and critical judgment and key estimates. 186 Table of Contents Emerging Growth Company As defined in Section 102(b)(1) of the JOBS Act, we are an emerging growth company (“EGC”).
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”).
While we have in-house clinical 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 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.
Other Expenses Our other expenses amounted to $4.5 million and $6.6 million for the years ended December 31, 2021 and 2022, respectively.
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.
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. 181 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, 2021 and 2022: Year Ended December 31, Change (In thousands of USD $, 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-122 457 717 260 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.
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.
If any of our product candidates enter into later stages of clinical development, they will generally have higher development costs than those in earlier stages of clinical development, primarily due to the increased size and duration of later-stage clinical trials.
Product candidates in later stages of clinical development will generally have higher development costs than those in earlier stages of clinical development, primarily due to the increased size and duration of later-stage clinical trials.
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 ordinary shares upon exercise of share options for $(141) thousand. 184 Table of Contents 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 ordinary shares upon exercise of share options for $(392) thousand.
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.
Contractual Obligations and Commitments The following table summarizes our contractual obligations as of December 31, 2022, 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 (In thousands of USD $) Total Less than 1 year 1-3 years 3-5 years More than 5 years Lease commitments $ 991 $ 614 $ 126 $ 251 $ — 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 5 years).
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).
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, 2020, 2021 and 2022: Years Ended December 31, (In thousands of USD $) 2020 2021 2022 Net cash flows used in operating activities $ (35,681 ) $ (43,312 ) $ (42,824 ) Net cash flows (used in) or from investing activities 2,325 (38,950 ) 29,053 Net cash flows (used in) or from financing activities 125,514 (1,643 ) (294 ) Net change in cash and cash equivalents $ 92,158 $ (83,905 ) $ (14,065 ) 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.
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” of this Annual Report, our actual results could differ materially from the results described in or implied by the forward-looking statements contained in the following discussion and analysis. 173 Table of Contents Company Overview We are a clinical-stage biotechnology company focused on the discovery and development of oncology therapies to address unmet medical needs.
“Risk Factors” of this Annual Report, our actual results could differ materially from the results described in or implied by the forward-looking statements contained in the following discussion and analysis. Company Overview We are a clinical-stage biotechnology company focused on discovering and developing oncology therapies to address unmet medical needs, especially for difficult-to-treat and treatment resistant cancers.
For the years ended December 31, 2021 and 2022, we had an accumulated deficit of $235.4 million and $474.6 million, respectively.
For the years ended December 31, 2022 and 2023, we had an accumulated deficit of $474.6 million and $647.0 million, respectively.
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. 179 Table of Contents We expect that our administrative expenses will increase substantially in the future as we increase our administrative personnel to support our continuing growth and we increase our costs of marketing and selling 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 expect that our administrative expenses will increase in the future to support public company expenses and potentially pre-commercial expenses.
We currently have no drug candidates 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. Since our inception, we have incurred significant operating losses.
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.
For the years ended December 31, 2021 and 2022, the fair value change of convertible preferred shares was $37.4 million and $189.6 million, respectively Research and Development Expenses An internally generated intangible asset arising from development activities (or from the development phase of an internal project) is recognized if, and only if, all of the following have been demonstrated: • the technical feasibility of completing the intangible asset so that it will be available for use or sale; • the intention to complete the intangible asset and use or sell it; • the ability to use or sell the intangible asset; • how the intangible asset will generate probable future economic benefits; • the availability of adequate technical, financial and other resources to complete the development and to use or sell the intangible asset; and • the ability to measure reliably the expenditure attributable to the intangible asset during its development.
An internally generated intangible asset arising from development activities (or from the development phase of an internally generated project) is recognized if, and only if, all of the following have been demonstrated: • the technical feasibility of completing the intangible asset so that it will be available for use or sale; • the intention to complete the intangible asset and use or sell it; • the ability to use or sell the intangible asset; • how the intangible asset will generate probable future economic benefits; • the availability of adequate technical, financial and other resources to complete the development and to use or sell the intangible asset; and • the ability to measure reliably the expenditure attributable to the intangible asset during its development.
We manage certain activities such as clinical trial operations, manufacture of therapeutic candidates, and preclinical animal toxicology studies through third-party CROs. 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 research and development expenses.
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.
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.
For the years ended December 31, 2020, 2021 and 2022, our net loss was $74.8 million, $94.8 million and $240.8 million, respectively and the fair value change of convertible preferred shares was $26.5 million, $37.4 million and $189.6 million, respectively, leaving net loss from operations as $48.3 million, $57.4 million and $51.2 million, respectively, which resulted substantially from research and development expenses and administrative expenses.
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.
Development costs which do not meet these criteria are expensed when incurred. Our directors assess the progress of each of the research and development projects and determine whether the criteria are met for capitalization.
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.
The following table represents our cash and cash equivalents and highly liquid financial assets as of December 31, 2021 and as of December 31, 2022: As of December 31, As of December 31, (In thousands of USD $) 2021 2022 Cash and cash equivalents $ 46,740 $ 32,675 Time Deposits with original maturity over three months 24,000 2,872 Long Term Time Deposits with original maturity over three months 7,842 4,307 Financial asset at FVTPL 23,744 19,067 Total $ 102,326 $ 58,921 183 Table of Contents 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, 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.
Additionally, future commercial and regulatory factors beyond our control will impact our clinical development program and plans. Administrative Expenses Administrative expenses consist primarily of salaries, benefits, and other related costs, including share-based payment expense, for personnel in our executive, operations, legal, human resources, finance, and administrative functions.
Administrative Expenses Administrative expenses consist primarily of salaries, benefits, and other related costs, including share-based payment expense, for personnel in our executive, legal, human resources, finance, and administrative functions.
Cash Flows From/Used in Investing Activities Net cash provided by investing activities was $2.3 million for the year ended December 31, 2020 resulting primarily from the proceeds from redemption of our time deposits with original maturity over three months for $11.0 million and interest received on such redemptions for $0.3 million, proceeds from disposal of our financial assets held at fair value for $7.0 million and repayment of the loan to one of our directors for $0.1 million, offset by the placement of time deposits with original maturity of three months for $6.0 million, additions of intangible assets for $10.0 million and additions 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 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.
Off-Balance Sheet Arrangements We did not have any off-balance sheet arrangements as of December 31, 2021 or 2022. F. Critical Accounting Estimates Our operating and financial review and prospects is based on our consolidated financial statements, which have been prepared in accordance with accounting policies that conform with International Financial Reporting Standards as issued by the International Accounting Standards Board.
Criti cal Accounting Estimates Our operating and financial review and prospects is based on our consolidated financial statements, which have been prepared in accordance with accounting policies that conform with International Financial Reporting Standards as issued by the International Accounting Standards Board.
Our other gains and losses amounted to a $36 thousand gain and an $(829) thousand loss for the years ended December 31, 2021 and 2022, respectively.
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.
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. 178 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 research and development activities; • future clinical trial results; • potential changes in government regulation; and • the timing and receipt of any regulatory approvals.
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.
Net cash used in operating activities was $35.7 million for the year ended December 31, 2020, resulting primarily from a net loss of $74.9 million, adjusted for non-cash charges of $0.6 million in depreciation and amortization including depreciation of operating right-of-use of assets, $1.0 million in impairment loss of an intangible asset, $4.5 million in share-based payments, $26.6 million in negative fair value change of our convertible preferred shares, $3.8 million in issuance costs for convertible preferred shares, $0.3 million in interest income, $0.1 million in positive fair value change of our financial assets, $72 thousand in finance costs, and $3.1 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 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.
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 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.
Cash Flows From/Used in Financing Activities Net cash provided by financing activities was $125.5 million for the year ended December 31, 2020 resulting primarily from the proceeds on issuance of our convertible preferred shares for $124.3 million, the proceeds on issuance of our ordinary shares upon exercise of share options for $6.0 million, offset by the issuance costs paid for $4.2 million and the repayment of our lease liabilities for $0.5 million.
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.
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.
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.
Further, we cannot predict impacts, trends and uncertainties involving the pandemic’s effects on economic activity, our customers, suppliers, manufacturers and partners, and the extent to which our revenue, income, profitability, liquidity, or capital resources may be materially and adversely affected. See also Item 5. “ Impacts of Macroeconomic Factors and COVID-19 Recovery ” and Item 3.D.
Further, we cannot predict impacts, trends and uncertainties involving the pandemic’s effects on economic activity, our customers, suppliers, manufacturers and partners, and the extent to which our revenue, income, profitability, liquidity, or capital resources may be materially and adversely affected. Regulatory Concerns We operate in an industry that is subject to extensive regulations, which have become more stringent over time.
As of December 31, 2022, 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.
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.
Key Factors Affecting Apollomics’ Operating Results We believe that our future performance and success depends to a substantial extent on our drug candidate pipeline and the development of our drug candidates, each of which is in turn subject to significant risks and challenges, including those discussed below and in the section of this Annual Report entitled “ Risk Factors .” Our Drug Candidate Pipeline The drug candidates in our existing pipeline can be categorized into three groups based on their mechanisms of action, each of which contains drug candidates at various stages of development: (i) tumor inhibitors; (ii) anti- cancer enhancers; and (iii) immuno-oncology drugs.
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.
We use both targeted, immuno-oncology, and other innovative approaches to address pipeline indications across a range of cancers, such as AML, lung cancer, brain cancer, and other solid tumors.
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.
From inception through December 31, 2022, we have incurred $128.7 million in research and development expenses. We plan to increase our research and development expenses for the foreseeable future as we continue the development of our therapeutic candidates, the discovery and development of preclinical therapeutic candidates, and the development of our clinical programs.
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.
Since our founding in 2015, we have built a pipeline of nine drug candidates across eleven programs that focus on oncology, of which six drug candidates are at clinical stage. Our strategic focus is the development of novel therapies targeting difficult to treat cancers.
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.
On the lease commencement, we recognized $0.5 million and $0.5 million of right-of-use asset and lease liabilities, respectively. C. Research and Development, Patents and Licenses, etc. 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.
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.
We have adopted a biomarker-driven diagnostic approach for patient screening to increase precision in identifying patients that can potentially benefit from target therapy. Two of our leading drug candidates, APL-101 and APL-106, have shown initial promising clinical results and are in the late stages of clinical development.
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.
In 2022 other expenses primarily include professional fees incurred by us in relation to the business combination transaction. We expect that our other expenses will increase substantially in the future as we continue to incur expenses for listing on Nasdaq.
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.
Removed
We also have a number of innovative drug candidates in earlier stages of clinical, preclinical, and discovery development. We operate in both the United States and China, with headquarters and global drug development team in the San Francisco Bay Area and our discovery and China drug development team in Hangzhou and Shanghai, China.
Added
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.
Removed
We believe that we benefit from these key centers of excellence in the biotechnology industries of the East and West. Business Combination On March 29, 2023, Apollomics consummated its Business Combination with Maxpro and Merger Sub. Pursuant to the Business Combination Agreement, Merger Sub merged with and into Maxpro, with Maxpro surviving the merger.
Added
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.
Removed
Upon consummation of the Business Combination and the other transactions contemplated by the Business Combination Agreement, Maxpro became a wholly owned subsidiary of Apollomics.
Added
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.
Removed
We believe that having three groups of drug 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 drug candidates consist of three small molecule inhibitors against different uncontrolled growth signaling pathways in cancer cells.
Added
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.
Removed
Our tumor inhibitor drug candidates are APL-101, APL-102, and APL-122. We are developing therapies that may target alternative pathways to overcome cancer treatment resistance, including chemo-resistance and targeted therapy resistance. 174 Table of Contents One of the most advanced drug candidates in our pipeline is our leading drug candidate, APL-101, a potent, highly selective c-Met inhibitor.
Added
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.
Removed
We are investigating APL-101 in clinical trials as a single agent for the potent treatment of non-small cell lung cancer (“NSCLC”) and other advanced tumors with c-Met alterations, and as a combination therapy with epidermal growth factor receptor (“EGFR”) inhibitors.
Added
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.
Removed
We have received orphan drug designation (ODD) of APL-101 for “treatment of non-small cell lung cancer with MET genomic tumor aberrations.” We intend to continue to explore the possibility of combining APL-101 with other drugs or drug candidates.
Added
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.
Removed
APL-102, is our oral active, small molecule MTKi that has shown anti-tumor activity in multiple preclinical studies, such as models of liver cancer, breast cancer and esophageal cancer, both as a single agent and in combination with an anti-PD-1 antibody.
Added
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.
Removed
As of the date of this Annual Report, APL-102 is in a Phase 1 dose escalation clinical trial and is at the fourth dose level, without observed toxicity in human subjects. APL-122 is our tumor inhibitor candidate. APL-122 targets ErbB1/2/4 signaling pathways and it is brain penetrating.
Added
Additionally, future commercial and regulatory factors beyond our control will impact our clinical development program and plans.
Removed
APL-122 is in Phase 1 dose escalation as of the date of this Annual Report. Anti-Cancer Enhancers Our anti-cancer enhancer drug candidates consist of two antagonists against a cell adhesion receptor, APL-106 and APL-108, which are being developed as adjuncts to chemotherapy to enhance its anti-cancer effects.
Added
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.
Removed
Binding of cancer cells to E-Selectin enhances their adhesion to the endothelium in bone marrow niches, thereby preventing the cancer cells from entering circulation and shielding them from chemotherapy. APL-106 (Uproleselan, GMI-1271), an E-selectin inhibitor, was granted fast track designation by the FDA and breakthrough therapy designation by NMPA in order to expedite its development.
Added
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.
Removed
APL-108 (GMI-1687), a second-generation E-selective inhibitor with even higher potency, is IND-ready for entry into clinical trials for other indications. We are advancing the preclinical and clinical development of APL-108, a next-generation E-Selectin antagonist with enhanced potency suitable for subcutaneous administration and potentially to target other liquid and solid cancers, that is currently in preclinical development.
Added
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.
Removed
Immuno-Oncology Drugs Our immuno-oncology drug candidates consist of four drug candidates: APL-501; APL-502; APL-801; and APL-810. These drug candidates may take the advantage of the body’s immune system to fight cancer and include mono-specific and bi-specific antibodies that could release the natural brakes of immune response against cancer cells, as well as a novel cancer vaccine.
Added
The increase of $2.0 million, or >100% , 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.
Removed
APL-501 is our anti-PD-1 antibody drug candidate. Genor, our partner in China for APL-501, has filed a BLA with the Chinese NMPA. APL-502 is our anti-PD-L1 antibody drug candidate and is being developed by Chia Tai Tian Qing Pharma (“CTTQ”), our partner in China under a tri-party agreement with the licensor.

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

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Biggest changeHayes 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. 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.
Biggest changeHayes 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.
The number of shares reserved for issuance under the 2023 Incentive Plan will increase automatically on January 1 of each year from 2024 through 2033 by the number of shares equal to the lesser of (i) 3% of the total number of outstanding shares (rounded down to the nearest whole share) of Apollomics Class A Ordinary Shares as of the immediately preceding December 31, or (ii) a number as may be determined by our Board.
The number of shares reserved for issuance under the 2023 Incentive Plan will increase automatically on January 1 of each year from 2024 through 2033 by the number of shares equal to the lesser of (i) 3% of the total number of outstanding shares (rounded down to the nearest whole share) of Class A Ordinary Shares as of the immediately preceding December 31, or (ii) a number as may be determined by our Board.
If there is any change in Apollomics’ corporate capitalization, the Committee in its sole discretion may make substitutions or adjustments to the number of Apollomics Class A Ordinary Shares reserved for issuance under the 2023 Incentive Plan, the number of Apollomics Class A Ordinary Shares covered by awards then outstanding under the 2023 Incentive Plan, the limitations on awards under the 2023 Incentive Plan, the exercise price of outstanding options and such other equitable substitutions or adjustments as it may determine appropriate.
If there is any change in Apollomics’ corporate capitalization, the Committee in its sole discretion may make substitutions or adjustments to the number of Class A Ordinary Shares reserved for issuance under the 2023 Incentive Plan, the number of Class A Ordinary Shares covered by awards then outstanding under the 2023 Incentive Plan, the limitations on awards under the 2023 Incentive Plan, the exercise price of outstanding options and such other equitable substitutions or adjustments as it may determine appropriate.
We have also engaged R&D and clinical development consultants, as well as general and administrative consultants, to support our operations. None of our employees are represented by a labor union or covered under a collective bargaining agreement. E. Share Ownership For information regarding the share ownership of directors and officers, see Item 7.A.
We have also engaged R&D and clinical development consultants, as well as general and administrative consultants, to support our operations. None of our employees are represented by a labor union or covered under a collective bargaining agreement. E. Shar e Ownership For information regarding the share ownership of directors and officers, see Item 7.A.
RSUs are contractual promises to deliver Apollomics Class A Ordinary Shares in the future, which may also remain forfeitable unless and until specified conditions are met and may be accompanied by the right to receive the equivalent value of dividends paid on shares of Apollomics Class A Ordinary Shares prior to the delivery of the underlying shares (i.e., dividend equivalent rights).
RSUs are contractual promises to deliver Class A Ordinary Shares in the future, which may also remain forfeitable unless and until specified conditions are met and may be accompanied by the right to receive the equivalent value of dividends paid on shares of Class A Ordinary Shares prior to the delivery of the underlying shares (i.e., dividend equivalent rights).
Board Practices Board of Directors Under Cayman Islands law, our directors owe fiduciary duties to our company, including a duty of loyalty, a duty to act honestly, and a duty to act in what they consider in good faith to be in our best interests. Our directors must also exercise their powers only for a proper purpose.
C. Board Practices Board of Directors Under Cayman Islands law, our directors owe fiduciary duties to our company, including a duty of loyalty, a duty to act honestly, and a duty to act in what they consider in good faith to be in our best interests. Our directors must also exercise their powers only for a proper purpose.
As of December 31, 2022, there were outstanding options to purchase 135,979,705 of our ordinary shares with a weighted average exercise price of $0.21, 67,667,737 of which were vested and exercisable, and 6,930,235 outstanding unvested restricted shares.
As of December 31, 2022, there were outstanding options to purchase 135,979,705 of our Class A Ordinary Shares with a weighted average exercise price of $0.21, 67,667,737 of which were vested and exercisable, and 6,930,235 outstanding unvested restricted shares.
Performance Awards . Performance awards granted pursuant to the 2023 Incentive Plan may be in the form of a cash bonus, or an award of performance shares or performance units denominated in Apollomics Class A Ordinary Shares, that may be settled in cash, property or by issuance of those shares subject to the satisfaction or achievement of specified performance conditions.
Performance Awards . Performance awards granted pursuant to the 2023 Incentive Plan may be in the form of a cash bonus, or an award of performance shares or performance units denominated in Class A Ordinary Shares, that may be settled in cash, property or by issuance of those shares subject to the satisfaction or achievement of specified performance conditions.
Apollomics Class A Ordinary Shares underlying awards under the 2023 Incentive Plan that are forfeited, canceled, expire unexercised or are settled in cash will be available again for new awards under the 2023 Incentive Plan.
Class A Ordinary Shares underlying awards under the 2023 Incentive Plan that are forfeited, canceled, expire unexercised or are settled in cash will be available again for new awards under the 2023 Incentive Plan.
Each award may be exercised during the participant’s lifetime only by the participant or, if permissible under applicable law, by the participant’s guardian or legal representative and may not be otherwise assigned, alienated, pledged, attached, sold or otherwise transferred or encumbered by a participant other than by will or by the laws of descent and distribution and any such purported assignment, alienation, pledge, attachment, sale, transfer or encumberance will be void and unenforceable against Apollomics or its affiliates.
Each award may be exercised during the participant’s lifetime only by the participant or, if permissible under applicable law, by the participant’s guardian or legal representative and may not be otherwise assigned, alienated, pledged, attached, sold or otherwise transferred or encumbered by a participant other than by will or by the laws of descent and distribution and any such purported assignment, alienation, pledge, attachment, sale, transfer or encumbrance will be void and unenforceable against Apollomics or its affiliates.
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.
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 compensation committee, however, may permit awards (other than ISOs) to be transferred to family members, a trust for the benefit of such family members, a partnership or limited liability company whose partners or stockholders are the participant and his or her family members or anyone else approved by it. Amendment and Termination; Repricing .
The compensation committee, however, may permit awards (other than ISOs) to be transferred to family members, a trust for the benefit of such family members, a partnership or limited liability company whose partners or shareholders are the participant and his or her family members or anyone else approved by it. Amendment and Termination; Repricing .
The compensation committee may provide that the delivery of the shares underlying RSUs will be deferred if such delivery would result in a violation of applicable law. The terms and conditions applicable to RSUs will be determined by the compensation committee, subject to the conditions and limitations contained in the 2023 Incentive Plan. Other Stock or Cash-Based Awards .
The compensation committee may provide that the delivery of the shares underlying RSUs will be deferred if such delivery would result in a violation of applicable law. The terms and conditions applicable to RSUs will be determined by the compensation committee, subject to the conditions and limitations contained in the 2023 Incentive Plan. Other Share or Cash-Based Awards .
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 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.
Carter, Dr. Hong-Jung (Moses) Chen and Glenn S. Vraniak are “independent directors” as defined in the Nasdaq listing standards. Our independent directors will have regularly scheduled meetings at which only independent directors are present.
Carter, Dr. Hong-Jung (Moses) Chen, Wendy Hayes and Glenn S. Vraniak are “independent directors” as defined in the Nasdaq listing standards. Our independent directors will have regularly scheduled meetings at which only independent directors are present.
The nominating and corporate governance committee is responsible for, among other things: • identifying and recommending nominees for election or reelection to the Board or for appointment to fill any vacancy; 192 Table of Contents • reviewing periodically with the Board its current composition in light of characteristics such as independence, knowledge, skills, experience and diversity; and • advising the Board periodically with respect to significant developments corporate governance.
The nominating and corporate governance committee is responsible for, among other things: • identifying and recommending nominees for election or reelection to the Board or for appointment to fill any vacancy; • reviewing periodically with the Board its current composition in light of characteristics such as independence, knowledge, skills, experience and diversity; and • advising the Board periodically with respect to significant developments corporate governance.
Stock options provide for the purchase of Apollomics Class A Ordinary Shares in the future at an exercise price set on the grant date. ISOs, in contrast to nonqualified stock options, may provide tax deferral beyond exercise and favorable capital gains tax treatment to their holders if certain holding period and other requirements of the Code are satisfied.
Share options provide for the purchase of Class A Ordinary Shares in the future at an exercise price set on the grant date. ISOs, in contrast to nonqualified share options, may provide tax deferral beyond exercise and favorable capital gains tax treatment to their holders if certain holding period and other requirements of the Code are satisfied.
In general, our Board may amend, alter, suspend, discontinue or terminate the 2023 Incentive Plan at any time. However, stockholder approval to amend the 2023 Incentive Plan may be necessary if applicable law or the 2023 Incentive Plan so requires.
In general, our Board may amend, alter, suspend, discontinue or terminate the 2023 Incentive Plan at any time. However, shareholder approval to amend the 2023 Incentive Plan may be necessary if applicable law or the 2023 Incentive Plan so requires.
The exercise price of a stock option or SAR may not be less than 100% of the fair market value of the underlying share on the grant date (or 110% in the case of ISOs granted to certain significant stockholders), except with respect to certain substitute awards granted in connection with a corporate transaction.
The exercise price of a share option or SAR may not be less than 100% of the fair market value of the underlying share on the grant date (or 110% in the case of ISOs granted to certain significant shareholders), except with respect to certain substitute awards granted in connection with a corporate transaction.
Other stock or cash based awards may be granted to participants and may also be available as a payment form in the settlement of other awards or as standalone payments. Dividend Equivalents .
Other share or cash based awards may be granted to participants and may also be available as a payment form in the settlement of other awards or as standalone payments. Dividend Equivalents .
Because we are a foreign private issuer, our audit committee is not subject to additional Nasdaq corporate governance requirements applicable to listed U.S. companies, including the requirements to have a minimum of three members and to affirmatively determine that all members are “independent,” using more stringent criteria than those applicable to foreign private issuers.
In general and notwithstanding the foregoing, because we are a foreign private issuer, our audit committee is not subject to additional Nasdaq corporate governance requirements applicable to listed U.S. companies, including the requirements to have a minimum of three members and to affirmatively determine that all members are “independent,” using more stringent criteria than those applicable to foreign private issuers.
Stockholder approval will not be required for any amendment that reduces the exercise price of any stock option or SAR, or cancels any stock option or SAR that has an exercise price that is greater than the then-current fair market value of Apollomics Class A Ordinary Shares in exchange for cash, other awards or stock options or SARs with an exercise price per share that is less than the exercise price per share of the original stock options or SARs.
Shareholder approval will not be required for any amendment that reduces the exercise price of any share option or SAR, or cancels any share option or SAR that has an exercise price that is greater than the then-current fair market value of Class A Ordinary Shares in exchange for cash, other awards or share options or SARs with an exercise price per share that is less than the exercise price per share of the original share options or SARs.
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.
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.
Dividend equivalents represent the right to receive the equivalent value of dividends paid on Apollomics Class A Ordinary Shares and may be granted alone or in tandem with awards other than stock options or SARs.
Dividend equivalents represent the right to receive the equivalent value of dividends paid on Class A Ordinary Shares and may be granted alone or in tandem with awards other than share options or SARs.
Committees of the Board of Directors The board of directors have the following standing committees: Audit Committee, Compensation Committee and Nominating and Corporate Governance Committee. 191 Table of Contents Audit Committee Our audit committee consists of Dr. Kenneth C. Carter, Wendy Hayes and Glenn S. Vraniak, with Glenn S. Vraniak serving as the chair. Dr. Kenneth C.
Committees of the Board of Directors The board of directors have the following standing committees: Audit Committee, Compensation Committee and Nominating and Corporate Governance Committee. Audit Committee Our audit committee consists of Dr. Kenneth C. Carter, Wendy Hayes and Glenn S. Vraniak, with Glenn S. Vraniak serving as the chair.
In connection with the Business Combination, the Apollomics Board adopted the 2023 Incentive Award Plan (as amended from time to time), which is referred to in this Annual Report as the “2023 Incentive Plan” and became effective as of the Closing.
In connection with the Business Combination, the Apollomics Board adopted the 2023 Incentive Award Plan (as amended from time to time), which is referred to in this Annual Report as the “ 2023 Incentive Plan ” and became effective as of the Closing.
Notwithstanding anything to the contrary in the 2023 Incentive Plan, no more than the number of shares of Apollomics Class A Ordinary Shares initially reserved under the 2023 Incentive Plan may be issued pursuant to the exercise of incentive stock options (“ISOs”) under the 2023 Incentive Plan.
Notwithstanding anything to the contrary in the 2023 Incentive Plan, no more than the number of shares of Class A Ordinary Shares initially reserved under the 2023 Incentive Plan may be issued pursuant to the exercise of incentive share options (“ISOs”) under the 2023 Incentive Plan.
The compensation committee may grant awards of nonqualified stock options, ISOs, stock appreciation rights (“SARs”), restricted stock, restricted stock units (“RSUs”), other stock-based awards, other cash-based awards, dividend equivalents, and/or performance compensation awards or any combination of the foregoing. Stock Options and Stock Appreciation Rights .
The compensation committee may grant awards of nonqualified share options, ISOs, share appreciation rights (“SARs”), restricted shares, restricted share units (“RSUs”), other share-based awards, other cash-based awards, dividend equivalents, and/or performance compensation awards or any combination of the foregoing. Share Options and Share Appreciation Rights .
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.
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.
In the event of certain capitalization events or corporate transactions (as set forth in the 2023 Incentive Plan), including the consummation of a merger or consolidation of us with another corporation, the compensation committee may adjust the number of Apollomics Class A Ordinary Shares or other securities of Apollomics (or number and kind of other securities or other property) subject to an award, the exercise or strike price of an award, or any applicable performance measure, and may provide for the substitution or assumption of outstanding awards in a manner that substantially preserves the terms of such awards, the acceleration of the exercisability or lapse of restrictions applicable to outstanding awards and the cancellation of outstanding awards in exchange for the consideration received by stockholders of Apollomics in connection with such transaction. 190 Table of Contents Aggregate Compensation of Office Holders C.
In the event of certain capitalization events or corporate transactions (as set forth in the 2023 Incentive Plan), including the consummation of a merger or consolidation of us with another corporation, the compensation committee may adjust the number of Class A Ordinary Shares or other securities of Apollomics (or number and kind of other securities or other property) subject to an award, the exercise or strike price of an award, or any applicable performance measure, and may provide for the substitution or assumption of outstanding awards in a manner that substantially preserves the terms of such awards, the acceleration of the exercisability or lapse of restrictions applicable to outstanding awards and the cancellation of outstanding awards in exchange for the consideration received by shareholders of Apollomics in connection with such transaction.
We initially reserved for the issuance of awards under the 2023 Incentive Plan the number of Apollomics Class A Ordinary Shares equal to 10% of all outstanding Apollomics Class A Ordinary Shares following the Closing.
We initially reserved for the issuance of awards under the 2023 Incentive Plan the number of Class A Ordinary Shares equal to 10% of all outstanding Class A Ordinary Shares following the closing of the Business Combination.
Other stock or cash based awards are awards of cash, fully vested Apollomics Class A Ordinary Shares and other awards valued wholly or partially by referring to, or otherwise based on, Apollomics Class A Ordinary Shares.
Other share or cash based awards are awards of cash, fully vested Class A Ordinary Shares and other awards valued wholly or partially by referring to, or otherwise based on, Class A Ordinary Shares.
The term of a stock option or SAR may not be longer than 10 years from grant (or five years in the case of ISOs granted to certain significant stockholders). Restricted Stock . Restricted stock is an award of nontransferable Apollomics 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. RSUs .
“ 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 .” 193 Table of Contents
“ 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 .”
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 expect to use equity-based awards to promote our interest by providing our executives with the opportunity to acquire equity interests as an incentive for their 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 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.
Item 6. Directors, Senior Management and Employees A. Directors and Senior Management Executive Officers and Directors The following table provides information about our directors and executive officers as of March 29, 2023. 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 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.
Vraniak 60 Director Dr. Jonathan Wang 55 Director 187 Table of Contents Executive Officers Dr. Sanjeev Redkar serves as our President and Principal Financial Officer. 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.
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.
Hayes serves on the boards of directors of multiple public companies, including TuSimple (Nasdaq: TSP) since December 2022, SciClone Pharmaceuticals (Holdings) Ltd (HK: 6600) since March 2021, Gracell Biotechnologies Inc. (NASDAQ: GRCL) since January 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.
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.
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. Lijuan Jane Wang serves as our Chief Scientific Officer. 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.
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.
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.
Compensation 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, 2022 was $6,044,066.
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.
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 is the founding president of the Chinese Biopharmaceutical Association USA and Chairman of the Bayhelix Group. 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. 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.
Sanjeev Redkar 54 President, Director and Principal Financial Officer Dr. Lijuan Jane Wang 59 Chief Scientific Officer Dr. Guo-Liang Yu 60 Chairman of the Board of Directors and Chief Executive Officer Dr. Kin-Hung Peony Yu 60 Chief Medical Officer Dr. Kenneth C. Carter 63 Director Dr. Hong-Jung (Moses) Chen 63 Director Wendy Hayes 53 Director Glenn S.
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.
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. 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 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.
As of December 31, 2022, we had reserved 337,225,866 of our 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.
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.
Redkar held various roles at SuperGen, Inc., including as senior manager of process development, senior director of pharmaceutical development and vice president in charge of manufacturing and preclinical development. Dr. Redkar has served as an External Advisory Board Member at the Department of Chemical and Biological Engineering of University of Colorado, Boulder since 2018. Dr.
Redkar held various roles at SuperGen, Inc., including as senior manager of process development, senior director of pharmaceutical development and vice president in charge of manufacturing and preclinical development. Dr. Redkar has served as an External Advisory Board Member at the University of the Pacific, T. J. Longs School of Pharmacy since 2007. Dr.
Compensation Committee Our compensation committee consists of Dr. Kenneth C. Carter, Dr. Hong-Jung (Moses) Chen and Wendy Hayes, with Dr. Kenneth C. Carter serving as the chair.
Compensation Committee Our compensation committee consists of Dr. Kenneth C. Carter, Dr. Hong-Jung (Moses) Chen and Wendy Hayes, with Dr. Kenneth C. Carter serving as the chair. Each of the members of our compensation committee meets the independence standards under Nasdaq corporate governance standards.
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.
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.
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. Previously, from October 2014 to January 2017, 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 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.
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.
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. From October 2019 to October 2021, Mr. Vraniak served as Chief Financial Officer of Evaxion Biotech A/S (Nasdaq: EVAX), where he led the company through an initial public offering.
From October 2019 to October 2021, Mr. Vraniak served as Chief Financial Officer of Evaxion Biotech A/S (Nasdaq: EVAX), where he led the company through an initial public offering. From August 2016 to April 2019, Mr. Vraniak served as Chief Financial Officer of electroCore, Inc. (Nasdaq: ECOR), where he led the company through an initial public offering. Mr.
Employees 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, 2022, we had 43 full-time employees.
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.
Yu has served on the board of directors of STAAR Surgical (Nasdaq: STAA). Dr. Yu earned an M.D. from the University of California Davis School of Medicine. 188 Table of Contents Directors Dr. Kenneth C. Carter serves as a member of our board of directors. Since 2020, 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.
Wang earned his Master of Arts, Master of Philosophy and Ph.D. from Columbia University. Dr. Wang also earned an MBA from Stanford University. 189 Table of Contents B.
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.
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. Wang served as a Partner at OrbiMed and co- founded OrbiMed Asia. In 2000, Dr. Wang co-founded BayHelix. Dr.
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.
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. Kin-Hung Peony Yu serves as our Chief Medical Officer. Dr. Yu has served as the Chief Medical Officer of Apollomics since March 2021. From 2008 to 2021, Dr.
Guo-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.
The 2023 Incentive Plan will have a term of not more than 10 years from the date it is approved by the Apollomics Shareholders, and no further awards may be granted under the 2023 Incentive Plan after that date. Awards Available for Grant .
The 2023 Incentive Plan has a 10-year term and expires on March 29, 2033, and no further awards may be granted under the 2023 Incentive Plan after that date. Awards Available for Grant .
From May 2013 to September 2018, Ms. Hayes served as the Inspections Leader at the Public Company Accounting Oversight Board in the United States. Ms. Hayes is a certified public accountant in the United States (California) and in China. Ms.
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.
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.
The 2016 Plan has not been amended since its adoption in July 2016.
Carter, Wendy Hayes and Glenn S. Vraniak meet the independence standards under Rule 10A-3 under the Exchange Act.
Each of the members of our audit committee meets the independence standards under Rule 10A-3 under the Exchange Act and under Nasdaq corporate governance standards.
Removed
Wang has served as the Chief Scientific Officer of Apollomics since July 2022. From March 2010 to July 2022, Dr. Wang served as Vice President, Medicinal Chemistry at WuXi AppTec Co. Ltd. From February 1998 to February 2010, Dr. Wang served as a senior principal scientist at Pfizer, Inc. Dr. Wang completed her postdoctoral studies at the U.S.
Added
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.
Removed
National Institute of Health and at Schering-Plough. Dr. Wang earned a Ph.D. from the University of Maryland Baltimore County and a B.S. in Applied Chemistry from Fudan University. 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.
Added
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.
Removed
Carter has served as the Global Head of Corporate Development and President of US Operations at Innoforce, Inc. Dr.
Added
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.
Removed
From August 2016 to April 2019, Mr. Vraniak served as Chief Financial Officer of electroCore, Inc., where he led the company through an initial public offering (Nasdaq: ECOR). Mr. Vraniak earned an electrical engineering technology degree and a managerial MBA from the Rutgers University Center for Management Development. Dr.
Added
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.
Added
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
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
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.

Item 7. Management's Discussion & Analysis

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

13 edited+9 added−6 removed5 unchanged
Biggest change“ Major Shareholders and Related Party Transactions—Related Party Transactions .” 5% Holders: Number of Apollomics Class A Ordinary Shares Beneficially Owned Percentage of Outstanding Apollomics Class A Ordinary Shares Number of Apollomics Class B Ordinary Shares Beneficially Owned Percentage of Outstanding Apollomics Class B Ordinary Shares Percentage of Total Voting Power OrbiMed Advisors LLC (1)(2) 662,561 10.5 % 17,331,074 21.6 % 20.8 % Alpha Intelligence Enterprises Limited (1) 288,598 4.6 % 7,461,932 9.3 % 8.9 % Shanghai Chongmao Investment Center LP (1) 275,441 4.4 % 7,121,771 8.9 % 8.5 % MP One Investment LLC (3) 3,721,300 54.1 % — — 10.8 % Name and Address of Beneficial Owners Executive Officers and Directors Dr.
Biggest change“ 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.
The beneficial ownership of ordinary shares is determined in accordance with the SEC rules and generally includes any ordinary shares over which a person exercises sole or shared voting or investment power.
The beneficial ownership of Class A Ordinary Shares is determined in accordance with the SEC rules and generally includes any Class A Ordinary Shares over which a person exercises sole or shared voting or investment power.
For purposes of the table below, we deem shares subject to options that are currently exercisable or exercisable within 60 days of March 29, 2023, and restricted share units that shall vest within 60 days of March 29, 2023, 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 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.
Unless otherwise noted below, each shareholder’s address is 989 E. Hillsdale Blvd., Suite 220 Foster City, CA 94404. A description of any material relationship that our principal shareholders have had with us or any of our affiliates since January 1, 2022 is included under Item 7.B.
Unless otherwise noted below, each executive officer and director’s address is 989 E. Hillsdale Blvd., Suite 220 Foster City, CA 94404. A description of any material relationship that our principal shareholders have had with us or any of our affiliates since January 1, 2022 is included under Item 7.B.
Major Shareholders The following table sets forth information with respect to the beneficial ownership of our shares as of December 31, 2022 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 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.
(4) Includes 2,668,750 Apollomics Class A Ordinary Shares issuable upon conversion of 2,135,000 Apollomics Series A Preferred Shares issued to Maxpro Investment Co., Ltd. in the PIPE Financing. 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.
(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.
Includes 619,400 Apollomics Class A Ordinary Shares issuable within 60 days of consummation of the Business Combination, 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.
(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.
The major shareholders listed above do not have voting rights with respect to their ordinary shares that are different from the voting rights of other holders of our ordinary shares. B. Related Party Transactions The following is a description of our related party transactions since January 1, 2022. Agreements with directors and officers Options and restricted share units .
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.
We have entered into agreements with certain of our office holders, exculpating them from a breach of their duty of care to us to the fullest extent permitted by law and undertaking to indemnify them to the fullest extent permitted by law, subject to certain exceptions, including with respect to liabilities resulting from the Business Combination to the extent that these liabilities are not covered by insurance. 194 Table of Contents 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.
We have entered into agreements with certain of our office holders, exculpating them from a breach of their duty of care to us to the fullest extent permitted by law and undertaking to indemnify them to the fullest extent permitted by law, subject to certain exceptions, including with respect to liabilities resulting from the Business Combination to the extent that these liabilities are not covered by insurance.
OrbiMed Advisors may be deemed to have voting power and investment power over the securities held by the OrbiMed Entities 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. Gordon, Sven H. Borho and W.
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.
Since our inception, we have granted options to purchase our ordinary shares to our executive officers. We describe our option plans under Item 6. “ Directors, Senior Management and Employees .” Exculpation, indemnification and insurance . We are permitted to exculpate, indemnify and insure our office holders to the fullest extent permitted under the laws of the Cayman Islands.
Agreements with directors and officers Options and restricted share units . Since our inception, we have granted options to purchase our Class A Ordinary Shares to our executive officers. We describe our option plans under Item 6. “ Directors, Senior Management and Employees .” Exculpation, indemnification and insurance .
The percentage of Apollomics Class A Ordinary Shares or Apollomics Class B ordinary shares (the “Apollomics Class B Ordinary Shares”), par value $0.0001 per share, beneficially owned is computed on the basis of 6,257,455 Apollomics Class A Ordinary Shares and 80,383,133 Apollomics Class B Ordinary Shares outstanding on March 29, 2023, after giving effect to the Business Combination and the PIPE Financing All of our shareholders, including the shareholders listed below, have the same voting rights attached to their ordinary shares.
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.
Carter Neild, each of whom disclaims beneficial ownership of the securities held by the OrbiMed Entities, except to the extent of their pecuniary interest therein. (3) The address of this securityholder is c/o Maxpro Capital Acquisition Corp., 5/F-4, No. 89, Songren Road, Xinyi District, Taipei City 11073.
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.
Removed
Guo-Liang Yu (1) 191,655 3.0 % 4,955,400 6.2 % 5.9 % Dr. Sanjeev Redkar (1) 142,379 2.2 % 3,681,321 4.6 % 4.4 % Dr. Lijuan Jane Wang (1) — — — — — Dr. Kin-Hung Peony Yu (1) — — — — — Dr. Kenneth C. Carter (1) — — — — — Dr.
Added
Guo-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.
Removed
Hong-Jung (Moses) Chen (3)(4) 6,420,050 67.3 % — — 7.1 % Wendy Hayes (1) — — — — — Glenn S. Vraniak (1) — — — — — Dr.
Added
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”).
Removed
Jonathan Wang (1) — — — — — All Executive Officers and Directors as a Group 6,754,084 72.5 % 8,636,721 10.8 % 17.4 % (1) The address of this securityholder is c/o Apollomics Inc., 989 E. Hillsdale Blvd., Suite 220, Foster City, California 94404.
Added
(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.
Removed
(2) 17,993,635 Apollomics Ordinary Shares, consisting of (i) 595,146 Apollomics Class A Ordinary Shares and (ii) 15,588,012 Apollomics Class B Ordinary Shares (consisting of (i) 15,388,012 Apollomics Class B Ordinary Shares issued as part of the consideration issued to existing Apollomics shareholders as part of the Business Combination and (ii) 200,000 Apollomics Class B Ordinary Shares issued as part of the PIPE Financing) are held of record by OrbiMed Asia Partners II, LP (“OAP2”).
Added
(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.
Removed
In addition, 1,810,477 Apollomics ordinary shares, consisting of 67,415 Apollomics Class A Ordinary Shares and 1,743,062 Apollomics Class B Ordinary Shares, are held of record by OrbiMed Asia Partners, LP (“OAP” and, together with OAP2, the “OrbiMed Entities”). OrbiMed Advisors LLC (“OrbiMed Advisors”) is the advisory company to the OrbiMed Entities.
Added
(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.
Removed
C. Interests of Experts and Counsel Not applicable.
Added
(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.
Added
(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.
Added
We are permitted to exculpate, indemnify and insure our office holders to the fullest extent permitted under the laws of the Cayman Islands.
Added
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.