SAN DIEGO and SUZHOU, China, May 22, 2024 (GLOBE NEWSWIRE) -- Adagene Inc. ("Adagene") (NASDAQ:ADAG), a company transforming the discovery and development of novel antibody-based therapies, today announced its participation in multiple investor conferences in June 2024. Adagene's Chairman, Chief Executive Officer and President of R&D, Peter Luo, Ph.D., will provide a company update, including progress on the masked, anti-CTLA-4 SAFEbody® ADG126. Company management will also host investor meetings. Jefferies ...

Exhibit 1.1 Adagene Inc. American Depositary Shares Each Representing 1.25 Ordinary Shares ($0.0001 par value per Ordinary Share) SALES AGREEMENT March 29, 2024 LEERINK PARTNERS LLC 1301 Avenue of the Americas, 12 Floor New York, New York 10019 Ladies and Gentlemen: Adagene Inc., an exempted company incorporated with limited liability under the laws of the Cayman Islands (the "Company"), confirms its agreement (this "Agreement") with Leerink Partners LLC (the "Agent"), as follows: | --- | --- | |----------- ...

PART I [Key Information](index=8&type=section&id=Item%203.%20Key%20Information) This section details principal investment risks for Adagene Inc., a Cayman Islands holding company with operations in China and the U.S., covering PRC oversight, financial prospects, clinical development, and potential PFIC status [Risk Factors](index=8&type=section&id=3.D.%20Risk%20Factors) The company faces unique risks due to its Cayman Islands holding structure and operations in China, including regulatory oversight, data privacy concerns, and potential adverse U.S. tax implications as a Passive Foreign Investment Company - The company's Cayman Islands holding structure and operations in PRC and U.S. present unique risks, particularly concerning PRC government influence, regulatory approvals for offshore offerings, cybersecurity, data privacy, and historical limitations on PCAOB inspections[13](index=13&type=chunk) - The company was likely a **Passive Foreign Investment Company (PFIC)** for the 2023 tax year and faces a significant risk of being a **PFIC** in 2024, which could lead to adverse U.S. federal income tax consequences for U.S. investors[24](index=24&type=chunk)[400](index=400&type=chunk)[402](index=402&type=chunk) [Information on the Company](index=84&type=section&id=Item%204.%20Information%20on%20the%20Company) This section details Adagene's corporate history, structure, and operations as a clinical-stage biotechnology company developing novel antibody-based cancer immunotherapies using its proprietary DPL platform [History and Development of the Company](index=84&type=section&id=4.A.%20History%20and%20Development%20of%20the%20Company) Adagene Inc., a Cayman Islands holding company incorporated in 2011, operates through subsidiaries in China and the U.S., having completed its Nasdaq IPO in 2021, while navigating HFCAA and PRC cybersecurity regulations - Adagene Inc. is a Cayman Islands holding company established in 2011, conducting R&D and business operations primarily through its subsidiaries in Suzhou, China, and the United States, completing its IPO on the Nasdaq in February 2021[405](index=405&type=chunk)[406](index=406&type=chunk) - On December 15, 2022, the PCAOB vacated its 2021 determination that it was unable to inspect auditors in mainland China and Hong Kong, leading Adagene not to expect identification as a Commission-Identified Issuer for the fiscal year ended December 31, 2023, though future risk remains as the PCAOB makes annual determinations[410](index=410&type=chunk) - The company believes it is not subject to cybersecurity review under current PRC measures as it does not process personal information of more than one million users and is not considered a 'critical information infrastructure operator', having not been investigated by the CAC or received related inquiries or sanctions as of the report date[415](index=415&type=chunk) [Business Overview](index=89&type=section&id=4.B.%20Business%20Overview) Adagene is a clinical-stage biotech company leveraging its proprietary Dynamic Precision Library (DPL) platform, including NEObody™, SAFEbody®, and POWERbody™ technologies, to develop novel antibody-based cancer immunotherapies and strategic collaborations - Adagene's core is its **Dynamic Precision Library (DPL)** platform, which fuels three proprietary antibody technologies: **NEObody™**, **SAFEbody®**, and **POWERbody™**, designed to create differentiated cancer immunotherapies[425](index=425&type=chunk)[426](index=426&type=chunk)[427](index=427&type=chunk) Adagene's Wholly-Owned Clinical Pipeline | Candidate | Target/Technology | Stage of Development | | :--- | :--- | :--- | | **ADG126** | anti-CTLA-4 SAFEbody | Phase 1b/2 Development | | **ADG116** | anti-CTLA-4 NEObody | Phase 1b/2 Evaluation | | **ADG206** | anti-CD137 POWERbody | Phase 1 Evaluation | | **ADG106** | anti-CD137 NEObody | Phase 1b/2 Evaluation | - The lead candidate, **ADG126**, is a masked anti-CTLA-4 **SAFEbody** in Phase 1b/2 trials, focusing on metastatic microsatellite-stable (MSS) colorectal cancer (CRC), with clinical data suggesting a best-in-class safety profile and differentiated efficacy, particularly in combination with anti-PD-1 therapy[425](index=425&type=chunk)[455](index=455&type=chunk) - Adagene has established key technology licensing collaborations, including agreements with Sanofi and Exelixis to develop antibody-based therapeutics using its **SAFEbody** technology, providing upfront payments, potential milestone payments, and royalties to offset R&D costs[437](index=437&type=chunk)[533](index=533&type=chunk)[534](index=534&type=chunk) [Operating and Financial Review and Prospects](index=149&type=section&id=Item%205.%20Operating%20and%20Financial%20Review%20and%20Prospects) This section analyzes Adagene's financial performance, highlighting a narrowed net loss in 2023 to US$18.9 million due to increased collaboration revenue and reduced R&D expenses, with strong liquidity expected to fund operations into 2026 [Operating Results](index=149&type=section&id=5.A.%20Operating%20Results) Adagene's net loss significantly narrowed to US$18.9 million in 2023, driven by increased collaboration revenue and a 55% reduction in R&D expenses due to strategic prioritization of ADG126 Consolidated Results of Operations (in thousands US$) | Metric | 2021 | 2022 | 2023 | | :--- | :--- | :--- | :--- | | Licensing and collaboration revenue | 10,175 | 9,293 | 18,111 | | Research and development expenses | (68,099) | (81,340) | (36,639) | | Administrative expenses | (14,440) | (11,874) | (8,673) | | **Loss from operations** | **(72,364)** | **(83,921)** | **(23,720)** | | **Net loss attributable to shareholders** | **(73,178)** | **(79,972)** | **(18,946)** | | **Net loss per ordinary share (Basic)** | **(1.46)** | **(1.48)** | **(0.35)** | - Research and development expenses decreased by **55.0%** in 2023 to **US$36.6 million**, down from **US$81.3 million** in 2022, a direct result of the company's strategic decision to focus clinical efforts and prioritize its masked, anti-CTLA-4 **SAFEbody** candidate, **ADG126**[777](index=777&type=chunk) R&D Expenses by Program (in thousands US$) | Program | 2021 | 2022 | 2023 | | :--- | :--- | :--- | :--- | | ADG126 | 3,543 | 19,229 | 20,855 | | ADG116 | 11,236 | 15,271 | 5,779 | | ADG106 | 14,798 | 4,604 | 2,209 | | Preclinical, research pipeline & others | 38,522 | 42,236 | 7,796 | | **Total** | **68,099** | **81,340** | **36,639** | [Liquidity and Capital Resources](index=161&type=section&id=5.B.%20Liquidity%20and%20Capital%20Resources) As of December 31, 2023, Adagene held US$109.9 million in cash and cash equivalents, a decrease from 2022, with management expecting current liquidity to fund operations into 2026 - As of December 31, 2023, the company held **US$109.9 million** in cash and cash equivalents, which management believes is sufficient to fund operations **into 2026**[792](index=792&type=chunk)[795](index=795&type=chunk) Consolidated Cash Flow Data (in thousands US$) | Cash Flow Activity | 2021 | 2022 | 2023 | | :--- | :--- | :--- | :--- | | Net cash used in operating activities | (43,415) | (48,612) | (28,455) | | Net cash used in investing activities | (2,510) | (686) | (77) | | Net cash (used in) generated from financing activities | 145,357 | 17,823 | (5,367) | | **Net increase (decrease) in cash** | **99,240** | **(30,632)** | **(33,825)** | - Net cash used in operating activities decreased to **US$28.5 million** in 2023 from **US$48.6 million** in 2022, primarily due to higher revenue from collaborations and lower R&D and administrative expenses[798](index=798&type=chunk)[800](index=800&type=chunk) [Directors, Senior Management and Employees](index=166&type=section&id=Item%206.%20Directors%2C%20Senior%20Management%20and%20Employees) This section details the company's leadership, board composition, compensation, and employee base, noting a decrease to 174 employees in 2023, with most in R&D - For the fiscal year ended December 31, 2023, the company paid an aggregate of **US$2.6 million** in cash compensation to its executive officers and **US$0.3 million** to its independent directors[854](index=854&type=chunk) - The company utilizes two primary share incentive plans: the 2019 Plan (under which no new awards are granted) and the 2021 Performance Incentive Plan, with outstanding awards under the 2019 Plan covering **2,538,070 ordinary shares** as of February 29, 2024[858](index=858&type=chunk) Employee Headcount by Function (as of Dec 31, 2023) | Function | Number of Employees | | :--- | :--- | | Research and Development | 118 | | General Administration | 53 | | Business Development and Marketing | 3 | | **Total** | **174** | - The total number of employees decreased from **248 at the end of 2022** to **174 employees** at the end of 2023[888](index=888&type=chunk) [Major Shareholders and Related Party Transactions](index=183&type=section&id=Item%207.%20Major%20Shareholders%20and%20Related%20Party%20Transactions) This section details major shareholders, including the Peter Luo act-in-concert group (21.8%), and outlines 2023 related party transactions for R&D services with WuXi AppTec Group and WuXi Biologics Principal Shareholders (as of Feb 29, 2024) | Shareholder | Beneficial Ownership % | | :--- | :--- | | Peter Luo act-in-concert group | **21.8%** | | HAN 2020 IRREVOCABLE TRUST | **10.9%** | | JSR Limited | **9.7%** | | Wuxi Pharmatech Healthcare Fund I L.P. | **9.0%** | | Asia Ventures II L.P. | **8.7%** | | General Atlantic Singapore AI Pte. Ltd. | **8.7%** | | F-Prime Capital Partners Healthcare Fund III LP | **6.1%** | | Panacea Venture Healthcare Fund II, L.P. | **5.0%** | - In 2023, the company purchased research and development services from related parties, including **US$0.8 million** from WuXi AppTec Group and **US$1.9 million** from WuXi Biologics[900](index=900&type=chunk) [Financial Information](index=184&type=section&id=Item%208.%20Financial%20Information) This section presents the company's consolidated financial statements and states its policy of not paying cash dividends, intending to retain earnings for business growth - The company has not previously declared or paid cash dividends and has no plans to do so in the near future, intending to retain earnings to fund business growth[903](index=903&type=chunk) [Additional Information](index=186&type=section&id=Item%2010.%20Additional%20Information) This section details the company's Cayman Islands corporate governance, including tax consequences for shareholders and its likely status as a Passive Foreign Investment Company (PFIC) for 2023 - The company is an exempted company incorporated in the Cayman Islands, and its affairs are governed by its memorandum and articles of association and the Companies Act of the Cayman Islands[909](index=909&type=chunk)[910](index=910&type=chunk) - The company believes it was likely a **Passive Foreign Investment Company (PFIC)** for its 2023 taxable year due to a decline in its market capitalization relative to its cash and cash equivalents, with a significant risk it will also be a **PFIC** for 2024, potentially resulting in adverse U.S. federal income tax consequences for U.S. Holders[947](index=947&type=chunk) [Quantitative and Qualitative Disclosures About Market Risk](index=196&type=section&id=Item%2011.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) The company's primary market risks include interest rate risk on cash holdings and foreign exchange risk from RMB fluctuations against the U.S. dollar, with no current hedging - The company's main market risks include interest rate risk on cash holdings and foreign exchange risk, particularly from the fluctuation of the RMB against the U.S. dollar[966](index=966&type=chunk)[967](index=967&type=chunk) PART II [Material Modifications to the Rights of Security Holders and Use of Proceeds](index=201&type=section&id=Item%2014.%20Material%20Modifications%20to%20the%20Rights%20of%20Security%20Holders%20and%20Use%20of%20Proceeds) This section details the use of approximately US$145.9 million net proceeds from the February 2021 IPO, with US$83 million allocated primarily to R&D by December 31, 2023 - The company raised net proceeds of approximately **US$145.9 million** from its February 2021 IPO[983](index=983&type=chunk)[984](index=984&type=chunk) - From the IPO date through December 31, 2023, the company has used **US$83 million** of the net proceeds, primarily for research and development activities[985](index=985&type=chunk) [Controls and Procedures](index=201&type=section&id=Item%2015.%20Controls%20and%20Procedures) Management concluded that the company's disclosure controls and internal control over financial reporting were effective as of December 31, 2023, based on the COSO framework - Management concluded that as of December 31, 2023, the company's disclosure controls and procedures were effective[987](index=987&type=chunk) - Based on an evaluation using the COSO framework, management concluded that the company's internal control over financial reporting was effective as of December 31, 2023[989](index=989&type=chunk) [Corporate Governance and Other Matters](index=202&type=section&id=Item%2016.%20Corporate%20Governance%20and%20Other%20Matters) This section covers corporate governance, including principal accountant fees (RMB 6.2 million in 2023), adherence to Cayman Islands home country practices as a foreign private issuer, and the company's cybersecurity risk management program - The company, as a foreign private issuer, follows certain Cayman Islands home country practices, exempting it from some Nasdaq corporate governance requirements, such as having a compensation committee composed entirely of independent directors and obtaining shareholder approval for certain securities issuances[1002](index=1002&type=chunk)[1005](index=1005&type=chunk) Principal Accountant Fees (in thousands RMB) | Service | 2022 | 2023 | | :--- | :--- | :--- | | Audit Fees | 5,800 | 6,200 | | **Total** | **5,800** | **6,200** | - The company has a cybersecurity risk management program overseen by its information security committee and managed by the Senior VP of Bioinformatics and IT, with no cybersecurity threats identified in 2023 that materially affected the company's business, operations, or financial condition[1009](index=1009&type=chunk)[1010](index=1010&type=chunk)[1011](index=1011&type=chunk) PART III [Financial Statements](index=205&type=section&id=Item%2018.%20Financial%20Statements) This section presents the audited consolidated financial statements for Adagene Inc. and its subsidiaries for 2021-2023, prepared under U.S. GAAP, including balance sheets, comprehensive loss, equity changes, and cash flows Consolidated Balance Sheet Highlights (in thousands US$) | Account | Dec 31, 2022 | Dec 31, 2023 | | :--- | :--- | :--- | | Cash and cash equivalents | 143,759 | 109,934 | | **Total Assets** | **152,400** | **115,729** | | Total current liabilities | 55,080 | 31,456 | | **Total Liabilities** | **69,309** | **45,169** | | **Total Shareholders' Equity** | **83,090** | **70,559** | Consolidated Statements of Comprehensive Loss Highlights (in thousands US$) | Account | 2021 | 2022 | 2023 | | :--- | :--- | :--- | :--- | | Licensing and collaboration revenue | 10,175 | 9,293 | 18,111 | | Research and development expenses | (68,099) | (81,340) | (36,639) | | **Net loss attributable to shareholders** | **(73,178)** | **(79,972)** | **(18,946)** |

Core Insights - Adagene Inc. reported significant advancements in its clinical pipeline, particularly with its lead candidate ADG126, a masked anti-CTLA-4 SAFEbody, demonstrating a best-in-class therapeutic index in metastatic microsatellite-stable colorectal cancer [1][2][26] - The company has initiated a phase 2 dose expansion study for ADG126, increasing patient enrollment to over 50, and introduced a new 20 mg/kg loading dose regimen, with data expected in 2024 [1][3][11] - Financially, Adagene ended 2023 with a cash balance of approximately US$110 million, which is projected to fund operations into 2026, alongside a notable increase in net revenue [1][13][14] Clinical Pipeline Highlights - ADG126 has shown a 30-fold improved therapeutic index and a mechanism for CTLA-4 mediated intratumoral Treg depletion, allowing for higher and more frequent dosing in combination with anti-PD-1 therapy [2][3] - In a phase 1b/2 trial, ADG126 demonstrated a differentiated safety profile with limited dose-dependent toxicities, achieving a 22% overall response rate in a subset of patients without liver metastases [3][4] - The ongoing clinical program for ADG126 includes a loading dose regimen and maintenance doses, with promising preliminary results in progression-free survival [4][11] Financial Performance - For the year ended December 31, 2023, Adagene reported net revenue of US$18.1 million, a 95% increase from US$9.3 million in 2022, primarily due to collaboration agreements [14] - Research and development expenses decreased by approximately 55% to US$36.6 million, reflecting a focused clinical strategy on ADG126 [15] - The net loss attributable to shareholders was US$18.9 million for 2023, significantly reduced from US$80.0 million in 2022, indicating improved financial health [18][20] Collaborations and Partnerships - Adagene has strategic collaborations with Exelixis and Sanofi, focusing on developing novel masked antibody-drug conjugates and bispecific antibodies, with potential milestone payments reaching up to US$2.5 billion [7][8] - The company is also collaborating with Roche on a phase 1b/2 trial evaluating ADG126 in combination with other therapies for hepatocellular carcinoma [8] Board of Directors Changes - Recent changes to the Board of Directors include the appointment of Dr. Ulf Grawunder as an independent director, enhancing the board's expertise in therapeutic antibody development [9][10]

- Global oncology expert brings deep insight in colorectal cancer and role of CTLA-4 therapy as a cornerstone for combination immunotherapy - SAN DIEGO and SUZHOU, China, March 07, 2024 (GLOBE NEWSWIRE) -- Adagene Inc. ("Adagene") (NASDAQ:ADAG), a company transforming the discovery and development of antibody-based therapies, today announced the appointment of Heinz-Josef Lenz, M.D., FACP, to its Scientific and Strategic Advisory Board (the "SAB"). Dr. Lenz is the Associate Director for Clinical Research an ...

- Data from first tranche of MSS CRC patients treated with ADG126 10 mg/kg every three weeks (Q3W) in dose expansion showed clinical benefit including confirmed responses at higher, more frequent and repeat doses of the anti-CTLA-4 therapy - - Preliminary survival analysis of ADG126 10 mg/kg dosing regimens in patients without liver and peritoneal metastases indicates best-in-class median progression-free survival (PFS) of seven months - - Data from additional patients at 10 mg/kg Q3W dosing regimen expecte ...

[Adagene Board of Directors Update (April 28, 2023)](index=1&type=section&id=Adagene%20Announces%20Updates%20to%20its%20Board%20of%20Directors) Adagene announced significant changes to its Board of Directors, including new appointments and resignations, effective April 28, 2023 [New Director Appointments](index=1&type=section&id=New%20Director%20Appointments) Adagene appointed three new members to its Board of Directors: Dr. Mervyn Turner, Dr. Fangyong (Felix) Du, and Ms. Yumeng Wang - Dr. Mervyn Turner was appointed as a director, bringing over 25 years of experience from Merck Research Laboratories, where he served as head of worldwide licensing and later as the first Chief Strategy Officer[1](index=1&type=chunk) - Dr. Fangyong (Felix) Du, Adagene's Chief Technology Officer since May 2019, was appointed as a director, having been with the company since January 2012[2](index=2&type=chunk) - Ms. Yumeng Wang was appointed as a director, designated by General Atlantic, focusing on healthcare and life sciences investments[3](index=3&type=chunk) [Director Resignations and Replacements](index=1&type=section&id=Director%20Resignations%20and%20Replacements) Lefei Sun resigned and was replaced by Yumeng Wang, while Yuwen Liu also resigned following the expiration of her term, with both confirming no disagreements - Yumeng Wang replaces Lefei Sun as a director, leading to Mr. Sun's resignation from the Board[3](index=3&type=chunk)[4](index=4&type=chunk) - Yuwen Liu resigned from the Board and the audit committee due to the expiration of her initial appointment term[4](index=4&type=chunk) - Both Lefei Sun and Yuwen Liu confirmed no disagreements with the Board and no matters related to their resignations requiring shareholder attention[4](index=4&type=chunk) [Management Commentary](index=2&type=section&id=Management%20Commentary) CEO Peter Luo welcomed the new directors, highlighting their experience, and expressed gratitude to the departing directors for their contributions - CEO Peter Luo expressed excitement about the new directors, anticipating their help in advancing clinical products, harvesting value from preclinical assets, and leveraging platform technologies for growth[5](index=5&type=chunk) - The CEO acknowledged the contributions of Lefei Sun over his four years of service and Yuwen Liu over the past year[5](index=5&type=chunk) [Company Overview](index=2&type=section&id=About%20Adagene) Adagene is a clinical-stage biotechnology company leveraging computational biology and AI to develop novel antibody-based cancer immunotherapies - Adagene is a platform-driven, clinical-stage biotechnology company focused on discovering and developing novel antibody-based cancer immunotherapies[6](index=6&type=chunk) - The company utilizes its proprietary Dynamic Precision Library (DPL) platform, comprising NEObody™, SAFEbody®, and POWERbody™ technologies, to design novel antibodies[6](index=6&type=chunk) [Safe Harbor Statement](index=2&type=section&id=Safe%20Harbor%20Statement) This statement includes forward-looking information regarding clinical development and commercialization, cautioning that actual results may differ due to various risks - The document contains forward-looking statements regarding clinical data, development activities, regulatory milestones, and commercialization of its product candidates[7](index=7&type=chunk) - Key risks that could cause actual results to differ include the ability to demonstrate drug safety and efficacy, unfavorable clinical results, regulatory approval decisions, and reliance on third parties for development and manufacturing[7](index=7&type=chunk)

Table of Contents | --- | --- | |-------|------------------------------------------------------------------------| | | Adagene Inc. | | | (Exact name of Registrant as specified in its charter) | | | N/A | | | (Translation of Registrant's name into English) | | | Cayman Islands | UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 20-F (Mark One) ☐ REGISTRATION STATEMENT PURSUANT TO SECTION 12(B) OR 12(G) OF THE SECURITIES EXCHANGE ACT OF 1934 OR ☒ ANNUAL REPORT PURSUANT TO SECTION 1 ...

Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 20-F (Mark One) ☐ REGISTRATION STATEMENT PURSUANT TO SECTION 12(B) OR 12(G) OF THE SECURITIES EXCHANGE ACT OF 1934 OR ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(D) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 31, 2021. OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(D) OF THE SECURITIES EXCHANGE ACT OF 1934 OR ☐ SHELL COMPANY REPORT PURSUANT TO SECTION 13 OR 15(D) OF THE SECURITI ...