Connect Biopharma Holdings Ltd

Connect Biopharma Holdings LtdCNTB财报

Nasdaq

Connect Biopharma Holdings Ltd is a clinical-stage global biopharmaceutical company dedicated to developing innovative targeted therapies for inflammatory, immunological and autoimmune diseases. Its core pipeline includes candidate treatments for asthma, atopic dermatitis and other conditions with high unmet medical needs, with main operations across the U.S., China and key global markets to deliver effective therapeutic solutions to patients.

What changed in Connect Biopharma Holdings Ltd's 10-K2023 vs 2024

Top changes in Connect Biopharma Holdings Ltd's 2024 10-K

82 paragraphs added · 1525 removed · 1 edited across 4 sections

Item 2. Properties

Properties — owned and leased real estate

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ITEM 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. 86 A. History and Development of the Company 86 B. Business Overview 88 C. Organizational Structure 135 D.
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ITEM 2. PROPERTIES. As of December 31, 2024, we had an operating lease for 3,628 square feet of office space in San Diego, California, with a lease term that expires on April 30, 2025.
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We also have an operating lease for 25,476 square feet of laboratory and office space in Taicang, China, with a lease term that expires on April 30, 2026. In February 2025, we relocated our corporate headquarters to a new location in San Diego, California which includes 6,942 square feet of office space. This space is leased through January 2028.
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We believe that our existing facilities are adequate to meet our current needs, and that suitable additional alternative space will be available in the future on commercially reasonable terms.

Item 3. Legal Proceedings

Legal Proceedings — active lawsuits and investigations

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Any of the foregoing could have a material adverse effect on our business, financial condition, results of operations or prospects. Further, the costs of attempting to protect our IT Systems against the foregoing risks and the costs of responding to a cyberattack are significant.
We are not currently party to any material legal proceedings, and we are not aware of any pending or threatened legal proceeding against us that we believe could have an adverse effect on our business, operating results or financial condition.
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ITEM 3. KEY INFORMATION. Company Overview We are a Cayman Islands holding company and, although we conduct a portion of our operations through our subsidiaries in the People's Republic of China, or PRC, we are not a Chinese operating company.
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ITEM 3. LEGAL PROCEEDINGS. From time to time, we may become involved in legal proceedings arising in the ordinary course of our business.
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For a detailed depiction of our organizational structure as of the date of this annual report, please see the diagram below. A. [Reserved] B. Capitalization and Indebtedness. Not applicable. C. Reasons for the Offer and Use of Proceeds. Not applicable. D. Risk Factors.
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Summary of Risk Factors An investment in our ADSs, is subject to a number of risks, including risks related to our limited operating history, financial position and capital requirements, risks related to the discovery, development and regulatory approval of our product candidates, risks related to our reliance on third parties, risks related to commercialization of our product 4 Table of Contents candidates, risks related to our business operations and industry, risks related to intellectual property, risks related to ownership of our ADSs, risks related to doing business in the People's Republic of China, or PRC, and general risks.
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Investors should carefully consider all of the information in this annual report before making an investment in the ADSs. The following list summarizes some, but not all, of these risks. Please read the information in the section entitled “Risk Factors” for a more thorough description of these and other risks.
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Risks Related to Our Limited Operating History, Financial Position and Capital Requirements • We have a limited operating history, have incurred significant operating losses since our inception and expect to incur significant losses for the foreseeable future.
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We may never generate any revenue or become profitable or, if we achieve profitability, we may not be able to sustain it. • We will require substantial additional financing to achieve our goals, and a failure to obtain or access this necessary capital when needed on acceptable terms, or at all, could force us to delay, limit, reduce or terminate our product development programs, commercialization efforts or other operations.
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Our existing capital will not be sufficient for us to fund our product candidates through regulatory approval, and we will need to raise additional capital to complete their development and commercialization. Risks Related to the Discovery, Development and Regulatory Approval of Our Product Candidates • Clinical drug development involves a lengthy and expensive process, with an uncertain outcome.
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We may incur unforeseen costs or experience delays in completing, or ultimately be unable to complete, the development and commercialization of our product candidates. • We depend on enrollment of patients in our clinical trials for our product candidates and may experience delays or difficulties enrolling patients in our clinical trials. • Our product candidates may be associated with serious adverse events or undesirable side effects or have other properties that could delay or halt their clinical development, delay or prevent their regulatory approval, limit their commercial potential or result in significant negative consequences. • We have conducted and may continue to conduct clinical trials for our product candidates in international sites, and the applicable regulatory authority may not accept data from trials conducted in foreign locations. • We have only two product candidates, rademikibart (formerly CBP-201) and icanbelimod (formerly CBP-307), in clinical development.
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If we are unable to successfully develop product candidates or experience significant delays in doing so, our business will be materially harmed. • Our approach to the discovery and development of product candidates based on potent T cell modulation activity is unproven, and we do not know whether we will be able to develop any products of commercial value, or if competing technological approaches will limit the commercial value of our product candidates or render our approach obsolete. • We have never submitted a New Drug Application, or NDA, or Biologics License Application, or BLA, and may be unable to do so for any of our product candidates. • The regulatory approval processes of the FDA, the PRC National Medical Products Administration, or the NMPA, the European Medicines Agency, or the EMA, and the European Commission, and comparable foreign authorities are lengthy, time consuming and inherently unpredictable, and if we are ultimately unable to obtain regulatory approval for our product candidates, our business will be substantially harmed. • Our product candidates for which we intend to seek approval as biologic products may face competition sooner than anticipated. • The proposed revision of the EU legislation on pharmaceuticals could lead to uncertainties over the regulatory framework that will be applicable to medicinal products in the EU, including orphan medicinal products.
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Risks Related to Our Reliance on Third Parties • We rely, and expect to continue to rely, on third parties, including independent clinical investigators and contract research organizations to conduct some aspects of our preclinical studies and clinical trials. • We contract with third parties for the manufacture of our product candidates for preclinical studies and our ongoing clinical trials and expect to continue to do so for additional clinical trials and ultimately, for commercialization.
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Risks Related to Commercialization of Our Product Candidates • The commercial success of our product candidates will depend upon the degree of market acceptance of such product candidates by physicians, patients, healthcare payors and others in the medical community. 5 Table of Contents • The successful commercialization of our product candidates, if approved, will depend in part on the extent to which governmental authorities and health insurers establish coverage, adequate reimbursement levels and favorable pricing policies.
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Risks Related to Our Business Operations and Industry • We are dependent on the services of our management and other clinical and scientific personnel, and if we are not able to retain these individuals or recruit additional management or clinical and scientific personnel, our business will suffer.
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Risks Related to Intellectual Property • Our success depends on our ability to obtain, maintain, protect and enforce our intellectual property and our proprietary technologies.
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Risks Related to Ownership of Our ADSs • The trading price of our ADSs could be highly volatile, and purchasers of the ADSs could incur substantial losses. • As a foreign private issuer, we are not subject to some U.S. securities law disclosure requirements that apply to a domestic U.S. issuer, which may limit the information publicly available to our shareholders. • Holders of our ADSs have fewer rights than shareholders and must act through the depositary to exercise their rights. • We have identified, experienced and may continue to identify and experience material weaknesses in our internal control over financial reporting in the future.
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Risks Related to Doing Business in the PRC • Changes in the political and economic policies of the PRC government may materially and adversely affect our business, financial condition and results of operations and may result in our inability to sustain our growth and expansion strategies. • The PRC government may intervene in or influence our operations in accordance with laws and regulations, which could result in a material change in our operations and significantly and adversely impact the value of our ADSs. • Until December 2022, the Public Company Accounting Oversight Board, or PCAOB, had historically been unable to inspect our independent registered public accounting firm’s audit work performed for our financial statements, and this inability of PCAOB to inspect our auditors in the past had deprived our investors of the benefits of such inspections.
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If, in the future, the PCAOB is once again unable to inspect or investigate completely the work of our independent registered public accounting firm, investors will be deprived of the benefits of PCAOB inspections. • Our ADSs and shares may be prohibited from trading under the HFCAA in the future if the PCAOB is once again unable to inspect or investigate completely auditors located in the PRC, and as a result the Nasdaq Global Market may make a determination to delist our securities.
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If this happens there is no certainty that we will be able to list our ADSs or shares on a non-U.S. exchange or that a market for our shares will develop outside of the U.S.
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The delisting of our ADSs or prohibition from trading, or the threat of their being delisted or prohibited from trading, may materially and adversely affect the value of our ADSs. • Compliance with the PRC’s new Data Security Law, Cybersecurity Review Measures, Personal Information Protection Law, regulations and guidelines relating to the multi-level protection scheme and any other future laws and regulations may entail significant expenses and could materially affect our business. • PRC laws and regulations governing our current business operations are sometimes vague and uncertain, and therefore, these risks may result in a material negative change in our subsidiaries’ operations, significant depreciation of the value of our ADSs, or a complete hindrance of our ability to offer or continue to offer our securities to investors, which could cause the value of the securities of investors to become worthless. • The approval and the filing with the China Securities Regulatory Commission, or CSRC, may be required under a PRC regulation in connection with any future offerings of our securities in the U.S. market. • Certain PRC regulations may make it more difficult for us to pursue growth through acquisitions.
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Any failure by us to comply with PRC anti-monopoly laws and regulations may result in governmental investigations or enforcement actions, litigation or claims against us and could have an adverse effect on our business, financial condition and results of operations. • We could be adversely affected by rising political tensions and any potential conflicts between the United States and the PRC. 6 Table of Contents • Recent litigation, regulatory scrutiny and negative publicity surrounding PRC-based companies listed in the United States may result in increased regulatory scrutiny of us and negatively impact the trading price of our ADSs. • Our business benefits from tax benefits or financial incentives and discretionary policies granted by governmental authorities in the PRC.
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Expiration, elimination or reduction of these incentives or policies would have an adverse effect on our results of operations. • We may be restricted by industry-specific laws and regulations from transferring our scientific data outside of the PRC. • Additional remedial measures could be imposed on PRC-based accounting firms, including our independent registered public accounting firm, in administrative proceedings instituted by the SEC, as a result of which our consolidated financial statements may be determined to not be in compliance with SEC requirements.
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General Risks • We are subject to risks arising from health epidemics, including COVID-19. • We are subject to risks associated with inflation pressures, natural disasters and failure to comply with environmental, health and safety laws and regulations.
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Holding Foreign Companies Accountable Act Pursuant to the Holding Foreign Companies Accountable Act, as amended, or the HFCAA if the SEC determines that we have filed audit reports issued by a registered public accounting firm that has not been subject to inspections by the PCAOB for two consecutive years, the SEC will prohibit our shares or the ADSs from being traded on a national securities exchange or in the over-the-counter trading market in the United States.
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As a result of such trading prohibition, the Nasdaq Global Market may make a determination to delist our securities. On December 16, 2021, the PCAOB issued a report to notify the SEC of its determination that the PCAOB was unable to inspect or investigate completely registered public accounting firms headquartered in the PRC and Hong Kong, including our auditor.
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In May 2022, the SEC listed us as a Commission-Identified Issuer under the HFCAA following the filing of our annual report on Form 20-F for the fiscal year ended December 31, 2021.
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On December 15, 2022, the PCAOB issued a report that vacated its December 16, 2021 determination and removed the PRC and Hong Kong from the list of jurisdictions where it is unable to inspect or investigate completely registered public accounting firms.
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For this reason, until such time as the PCAOB issues any new determination, we do not expect to be identified as a Commission-Identified Issuer under the HFCAA.
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If PCAOB determines in the future that it no longer has full access to inspect and investigate completely accounting firms in the PRC and Hong Kong and we continue to use an accounting firm headquartered in one of these jurisdictions to issue an audit report on our financial statements filed with the SEC, we would again be identified as a Commission-Identified Issuer.
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There can be no assurance that we would not be identified as a Commission-Identified Issuer in the future, and if we were so identified for two consecutive years, we would become subject to the prohibition on trading under the HFCAA and as a result the Nasdaq Global Market may make a determination to delist our securities. See Item 3.D.
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“Risk Factors— Risks Related to Doing Business in the PRC — Our ADSs and shares may be prohibited from trading under the HFCAA in the future if the PCAOB is unable to inspect or investigate completely auditors located in the PRC and as a result the Nasdaq Global Market may make a determination to delist our securities.
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If this happens there is no certainty that we will be able to list our ADSs or shares on a non-U.S. exchange or that a market for our shares will develop outside of the U.S.
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The delisting of our ADSs or prohibition from trading, or the threat of their being delisted or prohibited from trading, may materially and adversely affect the value of our ADSs.” Permissions, Approvals, Licenses and Permits Required from the PRC Authorities for Our Operations and for the Offering of Our Securities to Foreign Investors We conduct a portion of our business through our subsidiaries in the PRC.
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Our PRC subsidiaries have obtained all necessary licenses and approvals to conduct our operations in the PRC and, to date, no application for any such licenses and approvals has been denied. For details of the material permissions, approvals, licenses and permits that our PRC subsidiaries are required to obtain to conduct our operations in the PRC, see Item 4.B.
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“Business Overview – Material Permissions, Approvals, Licenses and Permits in the PRC.” If we fail to receive any requisite permission or approval from the CSRC, CAC or other PRC regulatory authorities for any securities offering or our operations, or the waiver of such permission or approval, in a timely manner, or at all, or inadvertently conclude that such permissions or approvals are not required, or if applicable laws, regulations, or interpretations change and obligate us to obtain such permission or approvals in the future, we may be subject to fines and penalties, suspension or limitations on our business activities in China, revocation of our business licenses, website closure, delay or restrictions on the contribution to the PRC of the proceeds from any securities offering, or other sanctions that could have a material adverse effect on our business, financial condition, results of operations, reputation and prospects.
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In addition, the CSRC, CAC or other PRC regulatory agencies 7 Table of Contents may also take actions requiring us, or making it advisable for us, to halt any future offerings.
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Consequently, if you engage in market trading or other activities in anticipation of and prior to the settlement and delivery of any securities we offer from time to time, you would be doing so at the risk that the settlement and delivery may not occur. See Item 3.D.
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“Risk Factors— Risks Related to Doing Business in the PRC — Compliance with the PRC’s new Data Security Law, Cybersecurity Review Measures, Personal Information Protection Law, regulations and guidelines relating to the multi-level protection scheme and any other future laws and regulations may entail significant expenses and could materially affect our business”; “Risk Factors— Risks Related to Doing Business in the PRC — PRC laws and regulations governing our current business operations are sometimes vague and uncertain, and therefore, these risks may result in a material negative change in our subsidiaries’ operations, significant depreciation of the value of our ADSs, or a complete hindrance of our ability to offer or continue to offer our securities to investors, which could cause the value of the securities of investors to become worthless”; and “Risk Factors— Risks Related to Doing Business in the PRC — The approval of the CSRC may be required under a PRC regulation in connection with any future offerings of our securities in the U.S. market.” Implications of Being an Emerging Growth Company and a Foreign Private Issuer Emerging Growth Company We are an “emerging growth company” as defined in the Jumpstart Our Business Startups Act of 2012, or the JOBS Act.
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As such, we may take advantage of specific exemptions from various reporting requirements that are applicable to other publicly traded entities that are not emerging growth companies.
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These exemptions include: • not being required to comply with the auditor attestation requirements of Section 404 of the Sarbanes-Oxley Act of 2002; • not being required to comply with any requirement that may be adopted by the PCAOB regarding mandatory audit firm rotation or a supplement to the auditor’s report providing additional information about the audit and the financial statements (i.e., an auditor discussion and analysis); • not being required to submit some executive compensation matters to shareholder advisory votes, such as “say-on-pay,” “say-on-frequency” and “say-on-golden parachutes;” and • not being required to disclose some executive compensation related items such as the correlation between executive compensation and performance and comparisons of the chief executive officer’s compensation to median employee compensation.
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As a result, we do not know if some investors will find our ADSs less attractive. The result may be a less active trading market for our ADSs, and the price of our ADSs may become more volatile.
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We will remain an emerging growth company until the earliest of: (i) the last day of the first fiscal year in which our annual gross revenues exceed $1.235 billion; (ii) the last day of the fiscal year following the fifth anniversary of the completion of our initial public offering; (iii) the date that we become a “large accelerated filer” as defined in Rule 12b-2 under the Exchange Act, which would occur if the market value of our common equity held by non-affiliates exceeds $700 million as of the last business day of our most recently completed second fiscal quarter; or (iv) the date on which we have issued more than $1 billion in non-convertible debt securities during any three-year period.
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Foreign Private Issuer We report under the Exchange Act as a non-U.S. company with foreign private issuer status.
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Even after we no longer qualify as an emerging growth company, as long as we qualify as a foreign private issuer under the Exchange Act, we will be exempt from specific provisions of the Exchange Act that are applicable to U.S. domestic public companies, including: • the sections of the Exchange Act regulating the solicitation of proxies, consents or authorizations in respect of a security registered under the Exchange Act; • the sections of the Exchange Act requiring insiders to file public reports of their stock ownership and trading activities and liability for insiders who profit from trades made in a short period of time; and • the rules under the Exchange Act requiring the filing with the SEC of quarterly reports on Form 10-Q containing unaudited financial and other specific information, or current reports on Form 8-K, upon the occurrence of specified significant events. 8 Table of Contents In addition, we will not be required to file annual reports and consolidated financial statements with the SEC as promptly as U.S. domestic companies whose securities are registered under the Exchange Act, and we will not be required to comply with Regulation FD, which restricts the selective disclosure of material information.
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Both foreign private issuers and emerging growth companies also are exempt from some more stringent executive compensation disclosure rules.
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Thus, even if we no longer qualify as an emerging growth company, but remain a foreign private issuer, we will continue to be exempt from the more stringent compensation disclosures required of companies that are neither an emerging growth company nor a foreign private issuer.
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RISK FACTORS Investors should carefully consider the risks and uncertainties described below and the other information in this annual report, including our consolidated financial statements and related notes appearing elsewhere in this annual report and in the section titled “Operating and Financial Review and Prospects,” before deciding whether to invest or maintain any investment in our ADSs.
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Our business, financial condition, results of operations or prospects could be materially and adversely affected if any of these risks occurs, and as a result, the market price of our ADSs could decline and some or all of their value may be lost. The risks and uncertainties described below are not the only ones we face.
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Additional risks and uncertainties not presently known to us or that we currently believe to be immaterial may also adversely affect our business. Risks Related to Our Limited Operating History, Financial Position and Capital Requirements We have a limited operating history, have incurred significant operating losses since our inception and expect to incur significant losses for the foreseeable future.
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We may never generate any revenue or become profitable or, if we achieve profitability, we may not be able to sustain it. Biopharmaceutical product development is a highly speculative undertaking and involves a substantial degree of risk. We are a clinical-stage biopharmaceutical company with a limited operating history upon which investors can evaluate our business and prospects.
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We commenced operations in 2012, and to date, we have focused primarily on organizing and staffing our company, business planning, raising capital, performing research and development activities, establishing our intellectual property portfolio, discovering potential product candidates and conducting preclinical studies and clinical trials.
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Our approach to the discovery and development of product candidates is unproven, and we do not know whether we will be able to develop any products of commercial value. We only have rademikibart and icanbelimod in clinical development.
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There is no guarantee that we will be able to continue the development of or advance any product candidate into further clinical trials, including to meet the capital requirements for such activities.
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We have not yet demonstrated an ability to successfully obtain regulatory approvals, manufacture a commercial scale product, or arrange for a third party to do so on our behalf, or conduct sales and marketing activities necessary for successful product commercialization.
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Consequently, any predictions made about our future success or viability may not be as accurate as they could be if we had a history of successfully developing and commercializing biopharmaceutical products. We have incurred significant operating losses since our inception. If our product candidates are not successfully developed and approved, we may never generate any revenue.
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Our net losses were USD 59.5 million and USD 118.1 million for the years ended December 31, 2023 and 2022, respectively. As of December 31, 2023, we had an accumulated loss of USD 539.3 million.
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Substantially all of our losses have resulted from expenses incurred in connection with our research and development programs and from general and administrative costs associated with our operations. Our product candidates will require substantial additional development time and resources before we would be able to apply for or receive regulatory approvals and begin generating revenue from product sales.
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We expect to continue to incur losses for the foreseeable future, and we anticipate these losses will increase substantially as we conduct our ongoing and planned preclinical studies and clinical trials, continue our research and development activities, increase our production capacity, and seek regulatory approvals for our product candidates, as well as hire additional personnel, obtain and protect our intellectual property and incur additional costs for commercialization or to expand our pipeline of product candidates.
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To become and remain profitable, we must succeed in developing and eventually commercializing products that generate significant revenue.
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This will require us to be successful in a range of challenging activities, including completing preclinical studies and clinical trials of our product candidates, obtaining regulatory approval for these product candidates and manufacturing, marketing and selling any products for which we may obtain regulatory approval. We are only in the preliminary stages of most of these activities.
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We may never succeed in these activities and, even if we do, may never generate revenues that are significant enough to achieve profitability. In addition, we have not yet demonstrated an ability 9 Table of Contents to successfully overcome many of the risks and uncertainties frequently encountered by companies in new and rapidly evolving fields, particularly in the biopharmaceutical industry.
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Because of the numerous risks and uncertainties associated with biopharmaceutical product development, we are unable to accurately predict the timing or amount of increased expenses or when, or if, we will be able to achieve profitability. Even if we do achieve profitability, we may not be able to sustain or increase profitability.
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If we fail to become and remain profitable, the value of our ADSs could be depressed and our ability to raise capital, expand our business, maintain our research and development efforts, diversify our product candidates or even continue our operations could be impaired, and some or all of the value of our ADSs could be lost.
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We will require substantial additional financing to achieve our goals, and a failure to obtain or access this necessary capital when needed on acceptable terms, or at all, could force us to delay, limit, reduce or terminate our product development programs, commercialization efforts or other operations.
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Our existing capital will not be sufficient for us to fund our product candidates through regulatory approval, and we will need to raise additional capital to complete their development and commercialization. The development of biopharmaceutical product candidates is capital-intensive.
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Since our inception, we have used substantial amounts of cash to fund our operations and we expect our expenses to increase in connection with our ongoing activities during the next few years, particularly as we conduct our ongoing and planned clinical trials of rademikibart and icanbelimod , continue research and development for any additional product candidates, and seek regulatory approval for our current product candidates and any future product candidates we may develop.
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In particular, we are actively seeking potential global and regional partners to provide additional experience and infrastructure to support the next phase of clinical development for our lead product candidate, rademikibart. There can be no assurance that we will secure any desired partnership on a timely basis or acceptable terms.
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Further, subject to the terms and conditions of each partnership, external factors beyond our control may affect our collection of milestone payments or royalty payments under such a partnership.
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For example, on November 21, 2023, Connect HK and Connect SZ, two of the Company’s wholly owned subsidiaries, or the Connect Licensor, have entered into an exclusive license and collaboration agreement, or the Simcere Agreement, with Simcere Pharmaceutical Co., Ltd., or the Simcere Licensee, to develop and commercialize rademikibart in Greater China. For additional information, see Item 10.C. “Material Contracts”.
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However, external factors such as changes in applicable laws, government actions or other similar circumstances beyond our control may cause delay or disruption in future payments owed to us by the Simcere Licensee under the Simcere Agreement.
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Further, failure of our PRC rademikibart trials in meeting the respective primary end points set forth in the trial protocols will entitle the Simcere Licensee to terminate the Simcere Agreement. In addition, as our product candidates progress through development and toward commercialization, we may need to make royalty or other payments to our licensors and other third parties.
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Furthermore, if and to the extent we seek to acquire or in-license additional product candidates or rights in the future, we may be required to make significant upfront payments, milestone payments, licensing payments, royalty payments and/or other types of payments.
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If we obtain regulatory approval for any of our product candidates, we also expect to incur significant commercialization expenses related to product manufacturing, marketing, sales and distribution. Because the outcome of any clinical trial or preclinical study is highly uncertain, we cannot reasonably estimate the actual amounts necessary to successfully complete the development and commercialization of our product candidates.
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Furthermore, we have incurred significant costs associated with operating as a public company, and we expect to continue to incur significant costs associated with our operation as a public company. Accordingly, we will need to obtain substantial additional funding in connection with our continuing operations.
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If we are unable to raise capital or find alternative sources of financing when needed or on attractive terms, we would be forced to delay, reduce or eliminate our research and development programs or any future commercialization efforts, including in connection with any license or collaboration agreement that we may have entered into or may enter into in the future, and we may need to focus our efforts on fewer product candidates to preserve our resources.
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Our operating plans and other demands on our cash resources may change as a result of many factors currently unknown to us, and we may need to seek additional funds sooner than planned, through public or private equity or debt financings or other capital sources, including potentially collaborations, licenses and other similar arrangements.
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In addition, we may seek additional capital due to favorable market conditions or strategic considerations even if we believe we have sufficient funds for our current or future operating plans.
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Any additional capital raising efforts may divert our management from their day-to-day activities, which may adversely affect our ability to develop and, if approved, commercialize our current and any future product candidates. Additional funding may not be available on acceptable terms, or at all.
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As a result of the COVID-19 pandemic and actions taken to slow its spread, as well as actual or anticipated changes in interest rates and economic inflation and the impact of the Russian-Ukraine war, the global credit and financial markets have experienced extreme volatility and disruptions, including severely diminished liquidity and credit availability, declines in consumer confidence, declines in economic growth, 10 Table of Contents increases in unemployment rates, and uncertainty about economic stability.
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If the equity and credit markets deteriorate, it may make any necessary debt or equity financing more difficult, more costly or more dilutive.

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Item 5. Market for Registrant's Common Equity

Market for Common Equity — stock, dividends, buybacks

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ITEM 5. OPERATING AND FINANCIAL REVIEW AND PROSPECTS. You should read the following discussion and analysis in conjunction with our audited financial statements, in each case, together with the accompanying notes included elsewhere in this Annual Report. Our audited financial statements have been prepared in accordance with IFRS, as issued by the International Accounting Standards Board.
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ITEM 5. MARKET FOR REGISTRANT’S COMMON EQUITY, RELATED STOCKHOLDER MATTERS AND ISSUER PURCHASES OF EQUITY SECURITIES. Information About Our ADSs Our ADSs are traded on The Nasdaq Global Market, under the symbol “CNTB.” Shareholders As of January 22, 2025, there were 1,331 holders of record of our ADSs.
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The following discussion includes forward-looking statements that involve risks, uncertainties and assumptions. Our actual results may differ materially from those anticipated in these forward-looking statements as a result of many factors, including but not limited to those described under “Item 3. Key Information—D. Risk Factors” and elsewhere in this Annual Report.
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The actual number of shareholders is greater than this number of record holders, and includes shareholders who are beneficial owners, but whose shares are held in street name by brokers and other nominees. This number of holders of record also does not include shareholders whose shares may be held in trust by other entities.
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Our consolidated financial statements are presented in U.S. dollars, or USD. The Company elected to change its presentation currency from RMB to USD with effect from January 1, 2023. Figures have been re-presented from January 1, 2021 to reflect the change in presentation currency from RMB to USD.
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Dividend Policy We have never paid dividends. We currently intend to retain all available funds and any future earnings for use in the operation of our business, and we do not anticipate paying any cash dividends in the foreseeable future.
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Upon approval of shareholders of the Company on March 12, 2021, every 1.74 ordinary shares were consolidated into one ordinary share (the “Share Consolidation”) (Note 20). A. Operating Results Overview We are a global clinical-stage biopharmaceutical company developing therapies for the treatment of T cell-driven inflammatory diseases.
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Securities Authorized for Issuance Under Equity Compensation Plans See Item 12 of Part III of this Annual Report on Form 10-K for information about our equity compensation plans which is incorporated by reference herein. Performance Graph Not applicable. Purchases of Equity Securities by the Issuer and Affiliated Purchasers None. Unregistered Sales of Equity Securities and Use of Proceeds None.
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Our core expertise is in the use of functional cellular assays with T cells to screen and discover potent product candidates against immune targets. Our two most advanced clinical-stage programs include highly differentiated product candidates against validated targets.
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Our lead product candidate, rademikibart, is an antibody designed to target IL-4Rα, which is a validated target for the treatment of inflammatory diseases such as AD and asthma. The estimated global market for AD was approximately $8.5 billion in 2022 and is expected to grow to $23.2 billion by 2028, with a compound annual growth rate, or CAGR, of 18.2%.
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The estimated global market for asthma was approximately $8.8 billion in 2022 and is expected to exceed $12.0 billion by 2028, a CAGR of 6.0%.
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We recently completed a pivotal trial in moderate-to-severe AD patients in the PRC, in which primary and key secondary endpoints were met in Stage 1 of the trial, followed by strong efficacy demonstrated during the Stage 2 maintenance portion of the trial.
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We also recently completed a global Phase 2b trial evaluating rademikibart in Type 2 inflammatory asthma, in which primary and key secondary endpoints were met. We are evaluating the initiation of a global Phase 3 program in adult patients with moderate-to-severe AD or moderate-to-severe asthma.
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Furthermore, we are developing icanbelimod, a modulator of a T cell receptor known as sphingosine 1-phosphate receptor 1, or S1P1, for the treatment of inflammatory bowel disease, or IBD.
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Specifically, we are developing icanbelimod for ulcerative colitis, or UC, in the context of seeking out-licensing partnerships. 136 Table of Contents Since our inception, we have devoted our resources to developing a differentiated drug discovery approach based on our deep understanding of the immune system and conducting preclinical studies and clinical trials, as well as protecting our intellectual property estate comprising multiple patent families.
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Additionally, we have applied resources to business planning and capital raising to develop a pipeline of product candidates. We have funded our operations primarily through equity and preferred shares financing.
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On March 23, 2021, we completed our initial public offering, or the IPO, for a total cash consideration of USD 219.9 million, before netting underwriting discounts and commissions of USD 15.4 million. As of December 31, 2023, we had USD 106.0 million in cash and cash equivalents and USD 12.6 million in short-term investments.
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As a research intensive, innovation-focused entity, we have incurred losses and experienced negative operating cash flows since inception. Our net losses were USD 118.1 million and USD 59.5 million for the years ended December 31, 2022 and 2023, respectively. As of December 31, 2023, we had an accumulated loss of USD 539.7 million.
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We expect to continue to incur significant expenses and operating losses for the foreseeable future as we conduct our ongoing and planned preclinical studies and clinical trials, continue our research and development activities, and seek regulatory approvals for our product candidates, as well as hire additional personnel, obtain and protect our intellectual property and expand our pipeline of product candidates.
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As our product candidates move further into clinical development stages, we may receive milestone and other payments from third parties with whom we may choose to collaborate. In addition, we may also receive revenues from product commercialization if we obtain regulatory approval for any of our product candidates.
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However, even with these sources of revenue and income, we may continue to experience losses and negative operating cash flows and may not be able to fund our late-stage programs without additional fundraisings, licensing or partnership proceeds.
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We believe that our existing cash and cash equivalents along with the short-term investments noted above will be sufficient to meet our anticipated daily operation needs for at least the next 12 months.
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Key Factors and Trends Affecting Our Business The future success of our business is predicated on the continuation of our research and development programs, initially by advancing rademikibart and icanbelimod through Phase 2 and Phase 3 clinical trials and then seeking regulatory approval in the United States, the PRC, Europe, Australia and other jurisdictions.
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We do not currently have sufficient capital resources to complete late-stage clinical trials of all our product candidates or in all planned indications.
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Key Components of Our Results of Operations Revenue We have executed an exclusive license and collaboration agreement and expect to recognize license revenue once the company substantially completes the transfer of the IP and know-how to the licensee.
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We do not currently have any approved products and do not expect to generate product revenue unless we obtain regulatory approval and commercialize our product candidates in the future.
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Operating Expenses Research and Development Expenses Research and development expenses are primarily related to third-party clinical trial costs, drug manufacturing costs, and other preclinical research for our product candidates and discovery efforts, along with payroll and related expenses and share-based compensation costs.
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Elements of research and development expenses primarily include (1) clinical trial expenses such as payments to CROs, investigators and clinical trial sites that conduct the clinical studies; (2) manufacturing costs for drug substance and drug product used in clinical trials; (3) expenses related to preclinical testing of our technologies; (4) consultant service related to the design of clinical trials and data analysis, (5) payroll and other related expenses of personnel engaged in research and development activities, (6) expenses to develop the product candidates, including raw materials and supplies, product testing, depreciation, and facility-related expenses, and (7) other research and development expenses.
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Research and development expenses are charged to expense as incurred when these expenditures relate to our research and development services and have no alternative future uses. 137 Table of Contents The majority of our third-party expenses have been related to the development of rademikibart and icanbelimod.
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During the years ended December 31, 2022 and 2023, we spent USD 54.1 million and USD 36.6 million, respectively, in clinical trial related expenses relating to rademikibart, and USD 26.3 million and USD 3.6 million, respectively, in clinical trial related expenses relating to icanbelimod. We deploy our personnel and facility-related resources across all of our research and development activities.
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We have substantially increased our research and development expenditures as we continue the development of our product candidates and conduct discovery and research activities for our preclinical programs.
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Product candidates in a later stage of clinical development 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.
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We expect that our research and development costs will continue to increase as we conduct ongoing, and plan and conduct new, preclinical studies and clinical trials and manufacture our product candidates.
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We cannot determine with certainty the timing of initiation, the duration, or the completion costs of current or future preclinical studies and clinical trials of our product candidates due to the inherently unpredictable nature of preclinical and clinical development. Preclinical and clinical development timelines, the probability of success and development costs can differ materially from expectations.
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We anticipate that we will make determinations as to which product candidates to pursue and how much funding to direct to each product candidate on an ongoing basis in response to the results of ongoing and future preclinical studies and clinical trials, regulatory developments and our ongoing assessments as to each product candidate’s commercial potential.
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It is likely that we will need to raise additional capital in the future for commercialization of our products, assuming that we obtain regulatory approval.
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Our clinical development costs are highly uncertain and may vary significantly based on factors such as: • per patient trial costs; • the number of trials required for approval; • the number of sites included in the trials; • the countries in which the trials are conducted; • the length of time required to enroll eligible patients; • the number of patients that participate in the trials; • the drop-out or discontinuation rates of patients; • potential additional safety monitoring requested by regulatory agencies; • the duration of patient participation in the trials and follow-up; • the cost and timing of manufacturing our product candidates; • the phase of development of our product candidates; and • the efficacy and safety profile of our product candidates.
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Any of these variables with respect to the development of our product candidates or any other future candidate that we may develop could result in a significant change in the costs and timing associated with their development.
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For example, if the FDA, the NMPA, or another regulatory authority were to require us to conduct preclinical studies and clinical trials beyond those we currently anticipate will be required for the completion of clinical development or if we experience significant delays in enrollment in any clinical trials, we could be required to expend significant additional financial resources and time on the completion of our clinical development programs.
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We may never succeed in obtaining regulatory approval for any of our product candidates.
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Administrative Expenses Administrative expenses primarily include payroll and related expenses for employees involved in general corporate functions including finance, legal, information technology, business development, investor relations, and human resources, share-based compensation costs, insurance costs, third-party audit and accounting fees, legal fees, rental and depreciation expenses related to facilities and equipment used by these functions, professional service expenses and other general corporate related expenses.
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We expect our administrative expenses to increase in the future to support our public company infrastructure and, if any of our product candidates receive marketing approval, commercialization activities.
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We also anticipated increased expenses related to professional fees, including audit, legal, regulatory and tax-related services, associated with maintaining compliance with Nasdaq listing and SEC requirements, director and officer insurance premiums, and investor relations costs associated with operating as a public company. 138 Table of Contents Net impairment losses Impairment losses relate to the write-off of assets including construction in process assets when we determine that there is a loss in the future economic value of the asset due to either a decline in the asset’s value or the termination of a project for which the asset was purchased.
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Other Income Other income consists of government grants received by us. Grants from the government are recognized at their fair value where there is a reasonable assurance that the grant will be received and we will comply with all attached conditions. Government grants received in advance of costs being incurred are deferred until the associated costs are recognized.
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Grants that compensate us for the cost of an asset initially are presented as deferred income and are recognized as income in consolidated statements of loss on a straight-line basis over the useful life of the associated asset.
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Other (Losses)/Gains—Net Other gains or losses consist of the foreign exchange gains and losses resulting from the settlement of foreign exchange transactions, most of which were denominated in U.S. dollars for the subsidiaries that have functional currency in RMB, investment income from investments recorded at fair value through profit and loss, interest income from cash equivalents, and investment income from short-term investments in wealth management products with various maturities which bear floating interest rates.
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The fair value of short-term investments in wealth management products is based on discounted cash flows using their expected returns. Changes in fair value of these financial assets are recorded in other income (losses)/gains—net. Finance Income Finance income is comprised primarily of interest income earned from short-term and long-term investments, bank and term deposits.
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Finance Cost Finance cost is mainly comprised of issuance costs for our financial instruments with preferred rights and interests for lease liabilities. Fair Value Loss of Financial Instruments with Preferred Rights The fair value of financial instruments with preferred rights that are not traded in an active market is determined using valuation techniques.
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We first determine the equity value and then allocated the equity value to each element of our capital structure using either an option pricing back-solve method, or OPM, or a hybrid method, which employs the concepts of the OPM and the probability-weighted expected return method, or PWERM, that merged into a single framework.
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The fair value difference is accounted for as fair value loss of financial instruments with preferred rights within the consolidated statements of loss. Income Tax Expense Income tax expense is recognized based on the income tax rates in the following main tax jurisdictions where we operate.
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We are incorporated in the Cayman Islands with subsidiaries in Hong Kong, China (PRC), Australia and the United States and is exempt from income tax in the Cayman Islands. Our United States entity is a service provider for the Hong Kong entity and as a result its cost-plus income is subject to taxation in the United States.
Removed
There is no tax expense in Hong Kong, PRC or Australia as there was no estimated assessable profit that was subject to tax during the years ended December 31, 2022 and 2023. 139 Table of Contents Results of Operations Comparison of the Years Ended December 31, 2022 and 2023 The following table summarizes key components of our results of operations for the periods indicated: Year Ended December 31, (In thousands) 2022 2023 Change Research and development expenses $ (96,630) $ (51,913) $ 44,717 Administrative expenses (20,806) (14,515) 6,291 Net impairment losses (4,698) — 4,698 Other income 929 1,580 651 Other gains—net 1,889 2,774 885 Operating loss (119,316) (62,074) 57,242 Finance income 1,544 2,714 1,170 Finance cost (21) (23) (2) Finance (cost)/income—net 1,523 2,691 1,168 Net loss before income tax (117,793) (59,383) 58,410 Income tax expense (298) (120) 178 Net loss for the year $ (118,091) $ (59,503) $ 58,588 Research and Development Expenses Research and development expenses decreased by USD 44.7 million from USD 96.6 million for the year ended December 31, 2022 to USD 51.9 million for the year ended December 31, 2023, primarily due to a decrease of USD 41.0 million in third-party clinical trial costs and associated drug substance and drug product manufacturing costs.
Removed
During the year ended December 31, 2022 we had more drug substance and drug product manufacturing activity for both rademikibart and icanbelimod as well as three additional clinical trials, the global Phase 2 trial for icanbelimod in UC, a global Phase 2 trial for rademikibart in the CSwNP indication, and a Phase 1 trial of a histamine receptor antagonist for pruritus associated with atopic dermatitis, that all ended prior to 2023.
Removed
In addition, our personnel costs decreased by USD 3.8 million for the year ended December 31, 2023 due to a reduction in research and development personnel. Administrative Expenses Administrative expenses decreased by USD 6.3 million from USD 20.8 million for the year ended December 31, 2022 to USD 14.5 million for the year ended December 31, 2023.
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The decrease in administrative expenses was primarily due to a USD 3.6 million reduction in professional services including consulting costs, recruiting fees, legal fees, and insurance costs, and a USD 2.3 million reduction in payroll and related compensation and benefit expenses for slightly lower headcount and lower share-based compensation expense.
Removed
Other Income Other income increased by USD 0.7 million from USD 0.9 million for the year ended December 31, 2022 to USD 1.6 million for the year ended December 31, 2023.
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This increase was primarily related USD 0.7 million in subsidies from the Chinese local government and a USD 0.9 million incentive from the Australian government for research and development activities.
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Other Gains—Net Other gains—net, increased by USD 0.9 million from USD 1.9 million for the year ended December 31, 2022 to USD 2.8 million for the year ended December 31, 2023.
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The increase was primarily attributable to a USD 2.3 million increase in investment income from investments recorded at fair value through profit and loss offset by a decrease in USD 1.1 million 140 Table of Contents in net foreign exchange gains.
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During 2023, the USD exchange rates against RMB increased slightly as compared to 2022, leading to less higher foreign exchange gains in 2023. Finance Income Finance income increased by USD 1.2 million from USD 1.5 million for the year ended December 31, 2022 to USD 2.7 million for the year ended December 31, 2023.
Removed
The increase was primarily due to (i) a USD 0.5 million increase in interest from bank and term deposits and (ii) a USD 0.7 million increase in investment income from investments recorded at fair value through other comprehensive income/(loss).
Removed
Finance Costs Finance costs remained the same at USD 0.02 million for each of the years ended December 31, 2022 and 2023, respectively. Income Tax Expense Income tax expense decreased by USD 0.2 million from USD 0.3 million for the year ended December 31, 2022 to USD 0.1 million for the year ended December 31, 2023.
Removed
The decrease is mainly related to lower activity during the year ended December 31, 2022 in Connect US, which for income tax purposes is a service provider for Connect HK and as a result its cost-plus income is taxed for federal and state income tax purposes in the United States.
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Comparison of the Years Ended December 31, 2021 and 2022 The following table summarizes key components of our results of operations for the periods indicated: Year Ended December 31, (In thousands) 2021 2022 Change Research and development expenses $ (80,496) $ (96,630) $ (16,134) Administrative expenses (19,014) (20,806) (1,792) Net impairment losses — (4,698) (4,698) Other income 2,950 929 (2,021) Other (losses)/gains—net (1,547) 1,889 3,436 Operating loss (98,107) (119,316) (21,209) Finance income 97 1,544 1,447 Finance cost (7) (21) (14) Finance income—net 90 1,523 1,433 Fair value loss of financial instruments with preferred rights (103,983) — 103,983 Net loss before income tax (202,000) (117,793) 84,207 Income tax expense (266) (298) (32) Net loss for the year $ (202,266) $ (118,091) $ 84,175 Research and Development Expenses Research and development expenses increased by USD 16.1 million from USD 80.5 million for the year ended December 31, 2021 to USD 96.6 million for the year ended December 31, 2022, primarily due to an increase of USD 15.6 million in third-party clinical trial costs for advancing our lead product candidates into later clinical trial phases.
Removed
Specifically, in 2022, we completed a global Phase 2b clinical trial of rademikibart in the United States, the PRC, Australia and New Zealand and initiated a stand-alone pivotal clinical trial of rademikibart in the PRC for adult AD patients with moderate-to-severe AD, which significantly increased clinical trial and manufacturing expenses.
Removed
In addition, we incurred additional drug supply and clinical expenses related to the global Phase 2 clinical trials of rademikibart for asthma and chronic rhinosinusitis with nasal polyposis, or CRSwNP, indications and the global Phase 2 trial for icanbelimod in UC and Crohn’s disease, or CD, indications. 141 Table of Contents Administrative Expenses Administrative expenses increased by USD 1.8 million from USD 19.0 million for the year ended December 31, 2021 to USD 20.8 million for the year ended December 31, 2022.
Removed
The increase in administrative expenses was primarily due to (i) a USD 1.5 million increase in payroll and related expenses for additional headcount, including share-based compensation expense, and resources needed in support of the growth of our business operations, (ii) a USD 0.2 million increase in office and software expenses, and (iii) a USD 0.3 million increase in depreciation and amortization expense.
Removed
Net impairment losses Net impairment losses during 2022 of USD 4.7 million are attributable to the write-off of construction in process assets related to the termination of the construction project to build a research and development laboratory, manufacturing facility, and administrative offices on land purchased in 2021.
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In April 2023, the Jiangsu Taicang HIDC, and Connect SZ entered into an agreement for the Jiangsu Taicang HIDC to repurchase from Connect SZ the land use rights at the original purchase price and to terminate the Land Use Agreement and the relevant provisions of the Investment Agreement.
Removed
The cancellation registration of the land use rights was completed in April 2023 and the Company received the purchase price in September 2023. Other Income Other income decreased by USD 2.1 million from USD 3.0 million for the year ended December 31, 2021 to USD 0.9 million for the year ended December 31, 2022.
Removed
This decrease was primarily related to a one-time grant of USD 1.7 million received in 2021 from the PRC government for the Company’s achievement of an IPO listing.
Removed
Other (Losses)/Gains—Net Other (losses)/gains—net, increased by USD 3.4 million from USD 1.5 million of other losses for the year ended December 31, 2021 to USD 1.9 million of net gains for the year ended December 31, 2022.
Removed
The increase was primarily attributable to (i) USD 2.0 million favorable fluctuations in foreign exchange rates in 2022 and (ii) a USD 0.2 million increase in investment income from investments recorded at fair value through profit and loss, and (iii) during 2021, the Company incurred a loss of USD 1.1 million due to a phishing incident which resulted in the Company remitting such amount to an account set up by the phishers rather than to one of the Company’s vendors.
Removed
No loss of company data nor any loss or compromise of third-party information has been discovered related to this phishing incident. During 2022, the USD exchange rates against RMB strengthened, leading to higher foreign exchange gains in 2022.
Removed
Finance Income Finance income increased by USD 1.4 million from USD 0.1 million for the year ended December 31, 2021 to USD 1.5 million for the year ended December 31, 2022.
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The increase was primarily due to (i) a USD 0.1 million increase in interest from bank and term deposits and (ii) a USD 1.4 million increase in investment income from investments recorded at fair value through other comprehensive income/(loss). Finance Costs The change in finance costs year over year was insignificant.
Removed
Fair Value Loss of Financial Instruments with Preferred Rights Fair value loss of financial instruments with preferred rights decreased by USD 104.0 million from USD 104.0 million for the year ended December 31, 2021 to USD nil for the year ended December 31, 2022.
Removed
All of the Company's financial instruments with preferred rights were converted into ordinary shares in 2021 in connection with the Company's IPO. Income Tax Expense Income tax expense increased by USD 0.03 million from USD 0.3 million for the year ended December 31, 2021 to USD 0.3 million for the year ended December 31, 2022.
Removed
The increase is mainly related to higher research and development activity during the year ended December 31, 2022 in Connect US, which for income tax purposes is a service provider for Connect HK and as a result its cost-plus income is taxed for federal and state income tax purposes in the United States. 142 Table of Contents Critical Accounting Policies and Estimates Our consolidated financial statements were prepared in accordance with IFRS Accounting Standards issued by the IASB.
Removed
Our consolidated financial statements have been prepared under the historical cost convention, as modified by the revaluation of financial assets at fair value through profit or loss, financial assets at fair value through other comprehensive income, and financial instruments with preferred rights. The Company elected to change its presentation currency from RMB to USD with effect from January 1, 2023.

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Item 7. Management's Discussion & Analysis

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

0 edited+73 added66 removed0 unchanged
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ITEM 7. MAJOR SHAREHOLDERS AND RELATED PARTY TRANSACTIONS. A. Major Shareholders.
Added
ITEM 7. MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS. The following discussion and analysis of our financial condition and results of operations should be read together with our audited financial statements and the related notes and other financial information included elsewhere in this Annual Report on Form 10-K.
Removed
The following table sets forth information relating to the beneficial ownership of our ordinary shares as of March 1, 2024 by: • each person, or group of affiliated persons, known by us to own beneficially 5% or more of our outstanding ordinary shares; and • each member of our board of directors and each of our executive officers.
Added
Some of the information contained in this discussion and analysis or set forth elsewhere in this Annual Report on Form 10-K, including information with respect to our plans and strategy for our business, include forward-looking statements that involve risks and uncertainties.
Removed
The number of ordinary shares beneficially owned by each entity, person, board member or executive officer is determined in accordance with the rules of the SEC, and the information is not necessarily indicative of beneficial ownership for any other purpose.
Added
You should review the “Risk Factors” included in Item 1A of this Annual Report on Form 10-K for a discussion of important factors that could cause our actual results to differ materially from the results described in or implied by the forward-looking statements contained in the following discussion and analysis.
Removed
Under such rules, beneficial ownership includes any shares over which the individual has sole or shared voting power or investment power as well as any shares that the individual has the right to acquire within 60 days of March 1, 2024 through the exercise of any option or other right.
Added
Introduction Management’s discussion and analysis of financial condition and results of operations is provided as a supplement to the Consolidated Financial Statements and Notes, included in Item 8 of this Annual Report on Form 10-K, to help provide an understanding of our financial condition, the changes in our financial condition and our results of operations.
Removed
Except as otherwise indicated, and subject to applicable community property laws, the persons named in the table have sole voting and investment power with respect to all ordinary shares held by that person. The percentage of ordinary shares beneficially owned is computed on the basis of 55,102,954 ordinary shares outstanding as of December 31, 2023 on an as-converted basis.
Added
Our discussion is organized as follows: • Overview. This section provides a general description of our business. • Critical accounting estimates. This section contains a discussion of the accounting estimates that we believe are important to our financial condition and results of operations and that require significant judgment and estimates on the part of management in their application.
Removed
Ordinary shares that a person has the right to acquire within 60 days of March 1, 2024 are deemed outstanding for purposes of computing the percentage ownership of the person holding such rights, but are not deemed outstanding for purposes of computing the percentage ownership of any other person, except with respect to the percentage ownership of all board members and executive officers as a group.
Added
In addition, all of our significant accounting policies are summarized in Note 2 to the Consolidated Financial Statements included in Item 8 of this Annual Report on Form 10-K. • Results of operations.
Removed
Unless otherwise indicated below, the address for each beneficial owner listed is c/o Connect Biopharma Holdings Limited, 12265 El Camino Real, Suite 350, San Diego, CA 92130, United States. 163 Table of Contents Name and Address of Beneficial Owner Number of Shares Beneficially Owned** Percentage of Shares Beneficially Owned 5% or Greater Shareholders: Entities affiliated with Panacea Opportunity Fund I, L.P.
Added
This section provides a general description of our operating expenses, as well as an analysis of our results of operations presented in the accompanying consolidated statements of operations and comprehensive loss by comparing the results for the year ended December 31, 2024 to the results for the year ended December 31, 2023. • Liquidity and capital resources.
Removed
(1) 12,000,000 21.8% BioFortune Inc. (2) 6,197,398 11.2% Shanghai Minhui Enterprise Management Consulting Partnership (Limited Partnership) (3) 5,306,149 9.6% Entities affiliated with Qiming Venture Partners (4) 4,840,898 8.8% Advantech Capital II Connect Partnership L.P. (5) 4,762,185 8.6% Entities affiliated with Lilly Asia Ventures ("LAV") (6) 3,336,907 6.1% Executive Officers and Directors: Zheng Wei, Ph.D. (7) 6,487,545 11.8% Wubin Pan, Ph.D.
Added
This section provides an analysis of our cash flows and a discussion of our outstanding commitments and contingencies that existed as of December 31, 2024. Included in this discussion is our financial capacity to fund our future commitments and a discussion of other financing arrangements.
Removed
(2) (8) 6,728,292 12.2% Steven Chan (9) 225,036 * Kan Chen, Ph.D. — * James Huang — * Jean Liu (10) 70,858 * Karen J. Wilson (11) 141,758 * Kleanthis G. Xanthopoulos, Ph.D.
Added
Overview Connect Biopharma, headquartered in San Diego, California, is a clinical-stage biopharmaceutical company focused on advancing rademikibart, a potentially best-in-class next generation IL-4Rα antibody, to transform care in asthma and chronic obstructive pulmonary disease. In June 2024, we announced new U.S.-based leadership with the appointment of Barry D.
Removed
(12) 138,848 * All directors and executive officers as a group (eight (8) persons) 13,792,337 25.0% * Indicates beneficial ownership of less than 1% of the total outstanding ordinary shares. ** Includes ordinary shares represented by ADSs.
Added
Quart, Pharm.D., as Chief Executive Officer and Director, and David Szekeres, as President. In addition, Kleanthis G. Xanthopoulos, Ph.D. assumed the role of Chairman of the Board. This change in leadership was the first step in transforming Connect into a U.S.-centric company and significantly reducing our footprint in China.
Removed
(1) As reported on a Schedule 13D filed February 23, 2024, Panacea Venture Healthcare Fund II, L.P. stated that it holds 12,000,000 ordinary shares. James Huang is the sole owner of Panacea Innovation Limited, which is the sole owner of Panacea Venture Healthcare Fund II GP Company, Ltd., which is the general partner of Panacea Venture Healthcare Fund II, L.P.
Added
We continued to make progress by (i) assembling an experienced U.S. management team with deep expertise in drug development and regulatory execution, including having collectively received FDA marketing approval for 16 therapeutic products, and with deep expertise in business development, corporate strategy, finance and operations; (ii) developing a rapid clinical development program for rademikibart, which is expected to be initiated in the first half of 2025; (iii) relocating our corporate headquarters to San Diego, California; (iv) transferring the initial manufacturing process of rademikibart to a U.S.
Removed
James Huang, a member of our board of directors, is the sole owner of Panacea Innovation Limited, which is the sole owner of Panacea Venture Healthcare Fund II GP Company, Ltd., which is the general partner of Panacea Venture Healthcare Fund II, L.P.
Added
CMO; and (v) taking additional steps to become more U.S.-centric, including the voluntary election to become a domestic filer with the SEC, beginning with this Annual Report on Form 10-K.
Removed
As a result, each of James Huang, Panacea Innovation Limited and Panacea Venture Healthcare Fund II GP Company, Ltd. may be deemed to share beneficial ownership of the Ordinary Shares directly reported herein, but each disclaims such beneficial ownership. The registered address of the Panacea entities is c/o Maples Corporate Services Limited, Ugland House, Grand Cayman KY1-1104, Cayman Islands.
Added
Critical Accounting Estimates A summary of the significant accounting policies is provided in Note 2 to our Consolidated Financial Statements included in Item 8 of this Annual Report on Form 10-K.
Removed
(2) As reported on a Schedule G/A filed February 13, 2024, BioFortune Inc., a company limited by shares organized under the laws of the British Virgin Islands, stated that it holds 6,158,016 ordinary shares, which consists of (i) 530,894 ordinary shares underlying stock options held by Wubin Pan, Ph.D., our President and Chairperson of our board of directors and (ii) 39,382 ordinary shares held by Dr.
Added
The discussion and analysis of our financial condition and results of operations are based on our consolidated financial statements, which have been prepared in accordance with accounting principles generally accepted in the U.S. 102 TABLE OF CONTENTS The preparation of these financial statements requires us to make estimates and judgments that affect the reported amounts of assets, liabilities, revenues and expenses, and related disclosure of contingent assets and liabilities.
Removed
Pan’s spouse. Dr. Pan is the sole shareholder of BioFortune Inc. and may be deemed to have voting and investment power over such shares. Dr. Pan disclaims beneficial ownership of such shares, except to the extent of any pecuniary interest therein. The registered address of BioFortune Inc. is Coastal Building, Wickham’s Cay II, P. O.
Added
We evaluate our estimates on an ongoing basis, including those related to revenue recognition, accrued research and development expenses, and share-based compensation.
Removed
Box 2221, Road Town, Tortola, British Virgin Islands. (3) Consists of 5,306,149 ordinary shares held by Shanghai Minhui Enterprise Management Consulting Partnership (Limited Partnership), a limited partnership formed under the laws of the PRC. Suzhou Xiangtang Venture Investment Limited, a limited liability company organized under the laws of the PRC and the ultimate shareholders of which are Mr.
Added
We base our estimates on historical experience and on assumptions that we believe to be reasonable under the circumstances, the results of which form the basis of making judgments about the carrying values of assets and liabilities that are not readily apparent from other sources. Actual results may differ materially from these estimates under different assumptions or conditions.
Removed
Gu Zhenqi and Mr. Gu Jianping, is the general partner of Shanghai Minhui Enterprise Management Consulting Partnership (Limited Partnership). The registered address of Shanghai Minhui Enterprise Management Consulting Partnership (Limited Partnership) is 1/F, Block 1, No. 251, Yao Hua Road, Pilot Free Trade Zone, Shanghai, PRC. The business address of Suzhou Xiangtang Venture Investment Limited, Mr. Gu Zhenqi and Mr.
Added
Management considers an accounting estimate to be critical if: it requires a significant level of estimation uncertainty, and changes in the estimate are reasonably likely to have a material effect on our financial condition or results of operations.
Removed
Gu Jianping is 9th Floor, Xiangtang Building, No. 168 East Shanghai Road, Taicang, Jiangsu Province, PRC.
Added
We believe the following critical accounting estimates describe the most significant judgments and estimates used in the preparation of our consolidated financial statements. Revenue Recognition Our license and collaboration revenues have been generated through a collaborative development, manufacturing and commercialization agreement.
Removed
(4) Represents (i) 96,285 ordinary shares held by Qiming Managing Directors Fund V, L.P., a Cayman Islands exempted limited partnership, (ii) 3,102,470 ordinary shares held by Qiming Venture Partners V, L.P., a Cayman Islands exempted limited partnership, (iii) 14,993 ordinary shares held by Qiming VII Strategic Investors Fund, L.P., a Cayman Islands exempted limited partnership, and (iv) 1,627,150 ordinary shares held by Qiming Venture Partners VII, L.P., a Cayman Islands exempted limited partnership.
Added
The terms of the agreement include the license of intellectual property and associated know-how and the provision of other goods and services. Payments to us under a collaborative agreement typically include one or more for the following: non-refundable, upfront license fees; manufacturing supply services; milestone payments; and royalties on future product sales.
Removed
The general partner of Qiming Venture Partners V, L.P. is Qiming GP V, L.P., whose general partner is Qiming Corporate GP V, Ltd., a Cayman Islands exempted company. Qiming Corporate GP V, Ltd. is also 164 Table of Contents the general partner of Qiming Managing Directors Fund V, L.P.
Added
We utilize key assumptions that require judgement to determine the stand-alone selling price for each performance obligation identified in the agreement, which may include revenue forecasts, expected development timelines, discount rates, probabilities of technical and regulatory success and costs for manufacturing clinical supplies. To date, our estimates have not differed materially from actual values.
Removed
The voting and investment power of the shares held by Qiming Managing Directors Fund V, L.P. and Qiming Venture Partners V, L.P. in our company is exercised by Qiming Corporate GP V, Ltd., which is beneficially owned by Messrs. Duane Kuang, Gary Rieschel, and Nisa Leung.
Added
Because the amount of revenue recognized for each performance obligation is determined based upon its relative stand-alone price, changes in the estimated fair value of the stand-alone selling price for each performance obligation may result in a significant change to our revenue, which could materially affect our results of operations or financial position.
Removed
The general partner of Qiming Venture Partners VII, L.P. and Qiming VII Strategic Investors Fund, L.P. is Qiming GP VII, LLC, a Cayman Islands limited liability company.
Added
Accrued Research and Development Expenses We estimate certain costs and expenses and accrue for these liabilities as part of our process of preparing financial statements. Examples of areas in which subjective judgments may be required include, among other things, costs associated with services provided by contract organizations for preclinical development, manufacturing of our Product Candidates and clinical trials.
Removed
The voting and investment power of the shares held by Qiming Venture Partners VII, L.P. and Qiming VII Strategic Investors Fund, L.P. in our company are exercised by Qiming GP VII, LLC, which is beneficially owned by Messrs. Duane Kuang, Gary Rieschel, and Nisa Leung. Messrs.
Added
We accrue for costs incurred as the services are being provided by monitoring the status of the trial or services provided, and the invoices received from our external service providers.
Removed
Duane Kuang, Gary Rieschel, and Nisa Leung disclaim beneficial ownership of such shares, except to the extent of any pecuniary interest therein. The registered address of the Qiming entities is M&C Corporate Services Limited, P.O. Box 309GT, Ugland House, South Church Street, George Town, Grand Cayman, Cayman Islands.
Added
In the case of clinical trials, a portion of the estimated cost normally relates to the projected cost to treat a patient in the trials, and this cost is recognized based on the number of patients enrolled in the trial. Other indirect costs are generally recognized on a straight-line basis over the estimated period of the study.
Removed
(5) Consists of 4,762,185 ordinary shares held by Advantech Capital II Connect Partnership L.P., a Cayman Islands exempted limited partnership, or Advantech. Advantech Capital II Investment Partners Limited, an exempted company incorporated under the laws of the Cayman Islands, is the general partner of Advantech and may be deemed to beneficially own specific shares held by Advantech.
Added
As actual costs become known to us, we adjust our accruals. Nonrefundable advance payments for goods and services, including fees for process development or manufacturing and distribution of clinical supplies that will be used in future research and development activities, are deferred and recognized as expense in the period that the related goods are consumed or services are performed.
Removed
Advantech Capital II Investment Partners Limited is beneficially owned and controlled by Advantech Capital Partners II Limited, which in turn is ultimately controlled by Hebert Pang Kee Chan. Mr. Chan disclaims beneficial ownership of the shares held by Advantech, except to the extent of any pecuniary interest therein.
Added
To date, our estimates have not differed materially from the actual costs incurred. However, subsequent changes in estimates may result in a material change in our accruals, which could also materially affect our balance sheet and results of operations. Share-based Compensation We estimate the fair value of each option grant using the binomial option pricing model.
Removed
The registered address of the Advantech entities is 190 Elgin Avenue, George Town, Grand Cayman KY1-9005, Cayman Islands. (6) Consists of (i) 1,824,605 ordinary shares held by LAV Biosciences Fund V, L.P., (ii) 300,000 ordinary shares held by LAV Star Limited, (iii) 300,000 ordinary shares held by LAV Opportunities Limited, and (iv) 912,302 ordinary shares held by Orchids Limited.
Added
This fair value is then amortized using the straight-line single-option method of attributing the value of share-based compensation to expense over the requisite service periods of the awards. Forfeitures are accounted for, as incurred, as a reversal of share-based compensation expense related to awards that will not vest.
Removed
The address of the LAV entities is Lilly Asia Ventures Rom 606-7, St. George's Building, 2 Ice House Street, Central, Hong Kong. (7) As reported on a Schedule 13G/A filed February 13, 2024, Dr.
Added
The fair value of each employee share purchase right is estimated on the grant date using the Black-Scholes option pricing model. The estimated fair value of each purchase right is then expensed on a straight-line basis over the requisite service period, which is generally the purchase period.
Removed
Wei holds (i) 5,928,164 ordinary shares and (ii) includes 559,381 ordinary shares underlying options that are exercisable as of March 1, 2024 or that will become exercisable within 60 days after such date. (8) Includes (i) 530,894 ordinary shares underlying stock options held of record by Dr.
Added
The binomial option pricing model and the Black-Scholes option pricing model require inputs of complex and subjective assumptions, including each option’s expected life and price volatility of the underlying shares.
Removed
Pan that are exercisable as of March 1, 2024; and (ii) 39,382 ordinary shares held of record by Dr. Pan’s spouse. (9) Includes 217,536 shares underlying options held by Mr. Chan that are exercisable within 60 days after March 1, 2024. (10) Represents 70,858 ordinary shares underlying options held by Ms.
Added
Recent Accounting Pronouncements See Note 2 to the Consolidated Financial Statements included in Item 8 of this Annual Report on Form 10-K. 103 TABLE OF CONTENTS Results of Operations Comparison of the Years Ended December 31, 2024 and 2023 License and Collaboration Revenues License and collaboration revenues relate to the Simcere License Agreement under which Simcere has been granted exclusive rights to develop, manufacture, and commercialize rademikibart for all indications in Greater China, including mainland China, Hong Kong, Macau, and Taiwan.
Removed
Liu that are exercisable within 60 days after March 1, 2024. (11) Includes 131,758 ordinary shares underlying options held by Ms. Wilson that are exercisable within 60 days after March 1, 2024. (12) Represents 138,848 ordinary shares underlying options held by Dr. Xanthopoulos that are exercisable within 60 days after March 1, 2024.
Added
License and collaboration revenues for the year ended December 31, 2024 were $26.0 million for the upfront license fee, achievement of certain development milestones and cost reimbursements. There were no license and collaboration revenues for the year ended December 31, 2023. Research and Development Expense All costs of research and development are expensed in the period incurred.
Removed
Some of our directors are associated with our principal shareholders as indicated in the table below: Director Principal shareholder Kan Chen, Ph.D. Entities affiliated with Qiming Venture Partners James Huang Entities affiliated with Panacea Opportunity Fund I, L.P. Wubin Pan, Ph.D. BioFortune Inc.
Added
Research and development expense consists primarily of fees paid to external service providers, salaries and related costs for personnel, share-based compensation expense, and other costs incurred related to our Product Candidates.
Removed
As of March 31, 2024, based on public filings with the SEC, there are no other major shareholders holding 5% or more of our ordinary shares or ADSs representing ordinary shares except as described above. As of March 31, 2024, there were four (4) ordinary shareholders of record with an address in the United States.
Added
Research and development expense consisted of the following (in thousands): December 31, 2024 2023 Rademikibart-related costs $ 16,304 $ 37,572 Other development related costs 460 4,018 Personnel costs and other expenses 9,541 8,920 Share-based compensation expense 2,951 2,492 Total research and development expense $ 29,256 $ 53,002 For the year ended December 31, 2024, research and development expense was $29.3 million, compared to $53.0 million for the same period in 2023.
Removed
Deutsche Bank Trust Company Americas, as depositary of our ADSs, held 36,530,101 ordinary shares. To our knowledge, except as disclosed above, we are not owned or controlled, directly or indirectly, by another corporation, by any foreign government or by any other natural or legal person or persons, severally or jointly.
Added
The decrease in rademikibart-related costs was primarily due to lower clinical trial and drug manufacturing expenses as a result of (i) completion of the rademikibart global Phase 2b program in patients with asthma in late 2023, (ii) completion of the rademikibart China pivotal trials for patients with atopic dermatitis in late 2023, and (iii) higher costs incurred during 2023 for the manufacturing of rademikibart clinical trial material.
Removed
To our knowledge, there are no arrangements or operations which may at a subsequent date result in us undergoing a change in control. Our major shareholders do not have different voting rights than any of our other shareholders. B. Related Party Transactions.
Added
The decrease in other development related costs was primarily due to the completion of the global Phase 2 trial in ulcerative colitis in 2023. At this time, due to the risks inherent in the clinical trial process, we are unable to estimate with any certainty the costs we will incur in the continued development of our Product Candidates.
Removed
The following is a description of material related party transactions we have entered into since January 1, 2021 with any members of our board of directors or executive officers and the holders of more than 5% of our ordinary shares. 165 Table of Contents Preferred Share Private Placements The following is a summary of our securities issuances in the past three years.
Added
Other than costs for outsourced services associated with our clinical programs, we generally do not track research and development expense by project; rather, we track such expense by the type of cost incurred.
Removed
The history of securities issuances set forth below does not give effect to the 1-for-1.74 share consolidation of our ordinary shares effected prior to our IPO. Ordinary Shares On April 14, 2020, we issued 245,798 ordinary shares to each of BioFortune Inc. and Zheng Wei, Ph.D.
Added
We expect research and development expense to increase in 2025 to support our development efforts, primarily due to the two Phase 2 trials of rademikibart, which we expect to initiate in the first half of 2025. The lengthy process of completing our clinical trials and seeking regulatory approval for our Product Candidates requires the expenditure of substantial resources.
Removed
From December 2018 through December 2020, we issued 4,473,305 ordinary shares to Connect Union as nominee for purposes of the implementation of awards issue or to be issued to employees, directors and consultants of our company pursuant to the 2019 Plan.
Added
General and Administrative Expense General and administrative expense primarily consists of salaries, share-based compensation expense and other related costs for personnel in executive, finance and accounting, information technology, legal and human resource functions.
Removed
In September 2021, Connect Union surrendered all such ordinary shares to us and ceased to hold ordinary shares issued by us as a nominee structure.
Added
Other general and administrative expense includes professional fees for legal, investor relations, accounting and other general corporate purposes, facility costs and insurance not otherwise included in research and development expense. For the year ended December 31, 2024, general and administrative expense was $19.2 million, compared to $16.1 million for the same period in 2023.
Removed
Upon the closing of our IPO, we issued (i) 12,937,500 ordinary shares represented by the ADSs purchased in the offering, (ii) 121,080 ordinary shares to our founders immediately after the closing of the offering as a result of the achievement of the Financing Condition, and (iii) 46,232 ordinary shares to the holders of Series C Preferred Shares pursuant to the anti-dilution provisions contained in the Shareholders Agreement.
Added
The increase was primarily due to costs associated with executive departures, including cash severance of $1.2 million and non-cash, share-based compensation expense related to certain stock option modifications of $0.6 million.

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