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Adagene Inc. (ADAG)

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    • Adagene Presents Preclinical Data from Lead SAFEbody™ Program, ADG126, at the American Association for Cancer Research (AACR) Annual Meeting 2021
      GlobeNewswire

      Adagene Presents Preclinical Data from Lead SAFEbody™ Program, ADG126, at the American Association for Cancer Research (AACR) Annual Meeting 2021

      SAN FRANCISCO and SUZHOU, China, April 13, 2021 (GLOBE NEWSWIRE) -- Adagene Inc. (“Adagene”) (Nasdaq: ADAG), a platform-driven, clinical-stage biopharmaceutical company committed to transforming the discovery and development of novel antibody-based immunotherapies, today announced updated preclinical data from its lead SAFEbody™ program, ADG126, are being presented at the American Association for Cancer Research (AACR) Annual Meeting 2021. “There is a critical unmet need for new anti-CTLA-4 therapies, and we are encouraged by the data generated to date, which demonstrate ADG126 has the potential to overcome the severe immune-mediated adverse reactions associated with the class,” said Peter Luo, Ph.D., Co-founder, Chief Executive Officer and Chairman of Adagene. “By leveraging our SAFEbody platform technology, designed to precisely and very efficiently mask the antibody binding interface and activate specifically within the tumor microenvironment, our preclinical data continues to highlight the opportunity to effectively deliver treatment; ADG126 has demonstrated superior systemic safety profile at efficacious dose levels with a significantly enlarged therapeutic index (TI). Our ongoing global Phase 1 trial is expected to provide clinical validation for our SAFEbody platform and our SAFEbody product candidate, ADG126. We have successfully finished DLT evaluation of 3 patients at 0.1 mg/kg of ADG126 and remain on track to report topline safety and efficacy data in the second half of 2021.” A copy of the poster presentation, entitled “A Novel Anti-CTLA-4 Checkpoint Inhibitor Prodrug to Address On-target Off-tumor Toxicity for Cancer Immunotherapy,” is available on the AACR website and is also available for download via our website (https://www.adagene.com/). The data presented show: Notable Findings: ADG126 demonstrated an impressive safety margin while maintaining its potent antitumor activity.Unique Epitope with Broad Species Cross-Reactivity: ADG126 targets a conserved epitope of CTLA-4 with broad species cross-reactivity and is an activatable prodrug for tumor suppression in multiple syngeneic mouse models in single and combination therapies.Differentiated Mechanism of Action: Although the activated ADG126 is softer in blocking CTLA-4 binding with its ligands than ipilimumab, the activated ADG126 exhibited more potent antibody dependent cellular cytotoxicity (ADCC) in the tumor microenvironment.Intra-Tumoral Treg Depletion: Treg cells in tumor tissues exhibited higher CTLA-4 expression than in peripheral tissues and were efficiently depleted upon treatment with ADG126 in the immune-competent mouse syngeneic colon tumor model.Human T-Cell Activation in Vitro: Activated ADG126 potently enhanced T-cell activation, measured by IL-2 secretion, whereas the masked ADG126 did not.In Vivo Monotherapy Antitumor Activity: ADG126 exhibited potent antitumor activity as a single agent in different immune-competent syngeneic mouse tumor models.In Vivo Combination Antitumor Activity: ADG126 combined synergistically with other IO agents, such as anti-PD-1 antibody, to inhibit tumor growth in vivo. Combination therapy significantly slowed tumor growth and caused complete regression in 50% of Lewis lung cancer mouse models.Safety and Tolerability: ADG126 was well tolerated in animals suggesting the potential for high therapeutic index. The highest non-severely toxic dose (HNSTD) was determined to be 200 mg/kg/dose, which is one of the highest reported HNSTD for anti-CTLA-4 antibodies. About ADG126ADG126 is a fully human antagonistic mAb targeting a novel epitope of CTLA-4 and has been shown to specifically deplete regulatory T-cells in tumors. ADG126 is Adagene’s lead SAFEbody™ product candidate. The SAFEbody technology, developed using Adagene’s AI-powered platform, enables binding of an antibody to a specific target only after conditional activation of the antibody in target tissues. In preclinical studies, ADG126 was well tolerated in cynomolgus monkeys and demonstrated an encouraging antitumor response in multiple immune-competent mouse tumor models in a dose-dependent manner both as a single agent and in combination with anti-PD-1 and other therapies. Unlike anti-PD-1/PD-L1 check point inhibitors, anti-CTLA-4 is known for its dose-dependent clinical response in single and combination therapies, which is severely limited by the narrow therapeutic window available to current anti-CTLA-4 therapies. The large safety margin shown by ADG126 GLP toxicology studies of up to 200 mg/kg in targeting CTLA-4 will make it possible to dose patients for their optimal clinical benefits in single and combination therapies. About AdageneAdagene Inc. (Nasdaq: ADAG) is a platform-driven, clinical-stage biopharmaceutical company committed to transforming the discovery and development of novel antibody-based cancer immunotherapies. Adagene combines computational biology and artificial intelligence to design novel antibodies that address unmet patient needs. Powered by its proprietary DPL platform, composed of NEObody, SAFEbody, and POWERbody technologies, Adagene’s highly differentiated pipeline features novel immunotherapy programs. Adagene has forged strategic collaborations with reputable global partners that leverage its technology in multiple approaches at the vanguard of science. For more information, please visit: https://investor.adagene.com. Safe Harbor StatementThis press release contains forward-looking statements, including statements regarding data from the ADG126 preclinical studies and Phase I clinical trial, the potential implications of clinical data for patients, and Adagene’s advancement of, and anticipated clinical development, regulatory milestones and commercialization of ADG126. Actual results may differ materially from those indicated in the forward-looking statements as a result of various important factors, including but not limited to Adagene’s ability to demonstrate the safety and efficacy of its drug candidates; the clinical results for its drug candidates, which may not support further development or regulatory approval; the content and timing of decisions made by the relevant regulatory authorities regarding regulatory approval of Adagene’s drug candidates; Adagene’s ability to achieve commercial success for its drug candidates, if approved; Adagene’s ability to obtain and maintain protection of intellectual property for its technology and drugs; Adagene’s reliance on third parties to conduct drug development, manufacturing and other services; Adagene’s limited operating history and Adagene’s ability to obtain additional funding for operations and to complete the development and commercialization of its drug candidates; Adagene’s ability to enter into additional collaboration agreements beyond its existing strategic partnerships or collaborations, and the impact of the COVID-19 pandemic on Adagene’s clinical development, commercial and other operations, as well as those risks more fully discussed in the “Risk Factors” section in Adagene’s filings with the U.S. Securities and Exchange Commission. All forward-looking statements are based on information currently available to Adagene, and Adagene undertakes no obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events or otherwise, except as may be required by law. Investors Contact:Raymond TamAdagene86-512-8777-3626ir@adagene.com Bruce MackleLifeSci Advisors646-889-1200bmackle@lifesciadvisors.com Media Contact:Annie Starr6 Degrees973-768-2170astarr@6degreespr.com

    • Adagene Reports Full Year 2020 Financial Results and Provides Corporate Updates
      GlobeNewswire

      Adagene Reports Full Year 2020 Financial Results and Provides Corporate Updates

      - Successfully completed Initial Public Offering raising approximately US$161 million in gross proceeds--Reported clinical data for anti-CD137 and two anti-CTLA-4 programs--Advanced five discovery programs into IND-enabling stage--Established multiple academic and industry partnerships--Further strengthened Executive Management team- SAN FRANCISCO and SUZHOU, China, March 31, 2021 (GLOBE NEWSWIRE) -- Adagene Inc. (“Adagene”) (Nasdaq: ADAG), a platform-driven, clinical-stage biopharmaceutical company committed to transforming the discovery and development of novel antibody-based immunotherapies, today reported financial results for the full-year ended December 31, 2020 and provided corporate updates. “In 2020 we made significant advancements and leveraged this momentum to build our business and successfully completed an initial public offering, raising approximately US$161 million in gross proceeds,” said Peter Luo, Ph.D., Co-founder, Chief Executive Officer and Chairman of Adagene. “We have the financial resources to maximize the value of our mature technology platform, unlock the value of our transformative pipeline and expedite both preclinical and clinical development. We expect 2021 to be a pivotal year for Adagene and look forward to multiple upcoming catalysts.” Recent Highlights and Upcoming Milestones ADG106: The lead NEObody™ program is a fully human ligand-blocking, agonistic anti-CD137 IgG4 mAb that is being evaluated in patients with advanced solid tumors and/or non-Hodgkin’s lymphoma. Key priorities for 2021 will be to initiate the biomarker-driven Phase 2 global trial, identify optimal drug combinations and explore niche indications for expedited approval. 2021 anticipated milestones: ADG106-1008 Phase 1b read-out from China trial in combination therapy in 1H21ADG106-1003 Phase 1b read-out from Australia trial in combination therapy in 2H21ADG106-2001 Phase 2 read-out from global trial (biomarker mono/combo) in 2H21 Patient enrollment was completed in trials with ADG106-1001 and ADG106-1002 in the US and China respectively. A successful End of Phase 1 meeting was held with the FDA. Data from the trial show signs of safety, tolerability and supports the future clinical development of ADG106. ADG106 was generally well-tolerated with a dose escalation up to 10 mg/kg.Observed dose dependent increases in nature killer (NK) cells in ADG106 mediated anti-tumor activities. Demonstrated dose dependent increases in soluble CD137 induction ratio over the baseline upon ADG106 treatment.Identified a potential predictive biomarker to enhance patient selection. In retrospective analysis, the majority of patients selected with the biomarker demonstrated more than 30% tumor shrinkage across different indications. Developed a high sensitivity biomarker assay and obtained a CLIA certification for the upcoming biomarker driven Phase 2 study (ADG106-2001). In March 2021, initiated patient enrollment for an Investigator trial in China to explore clinical safety and efficacy of ADG106 in combination with anti-PD1 approved drug, Toripalimab. Three patients have been dosed. ADG116: The second NEObody program, which targets a unique epitope of CTLA-4 with a novel MOA, is being evaluated in patients with advanced/metastatic solid tumors. 2021 anticipated milestones: Safety and efficacy read out in selected indications in 2H21Expand in selected indications in Australia, the US, and China In March 2021, advanced the dose-escalation of ongoing Phase 1 clinical trial evaluating the safety and tolerability of ADG116 in patients with advanced/metastatic solid tumors in Australia. Completed dose escalation of the first four doses. Finished dosing three patients at the fifth dose. No dose limiting toxicity or ≥Grade 2 treatment related SAEs have been observed. Promising pharmacodynamic biomarker signals have been observed, consistent with preclinical observations and demonstrate clinical proof of mechanism. Notably, a patient refractory to prior pembrolizumab therapy (> 25 cycles) demonstrated striking increases in T and NK cells, and CD8+ and CD4+ TEM / Treg. ADG126: The lead SAFEbody™ program targets CTLA-4 and has been shown in preclinical studies to be safer, potent and more durable than a commonly used CTLA-4 cancer therapy. 2021 anticipated milestones: Present an update on preclinical data at the AACR Annual Meeting, 2021 (April 10-15th)Safety and efficacy read out in selected indications in 2H21Expand clinical trial in selected investigations in China In March 2021, dosed the first three patients in a global Phase 1 clinical trial of ADG126 for the treatment of various advanced solid tumors. The global Phase 1 open-label, dose-escalation clinical trial is investigating the tolerability and anti-tumor activity of ADG126 in patients with advanced/metastatic tumors in multiple clinical sites in Australia.Received approval from the FDA to initiate the Phase 1 clinical trial of ADG126 in the US. Discovery Programs: Generated with NEObody, SAFEbody and/or POWERbody technologies. 2021 anticipated milestones: Advance additional discovery programs into IND enabling studies. The Company has over ten programs in discovery and five highly differentiated programs undergoing IND-enabling studies, namely three POWERbody programs and two SAFEbody programs POWERbody programs include bispecific T-cell engagers.All five programs have robust CMC profile with encouraging preclinical safety and efficacy data. Collaborations: Established strong academic and industry strategic partnerships. In March 2021, through a collaboration with Guilin Sanjin Pharmaceutical Co., Ltd., or Sanjin, and its affiliates, received IND approval from the National Medical Products Administration (NMPA) in China to initiate clinical trials for an undisclosed monoclonal antibody. This will mark the fifth antibody into the clinic generated by Adagene platform. ADG104, a monospecific antibody that targets PD-L1 and is in Phase 1b and Phase 2 clinical trials concurrently in China, is also being developed in collaboration with Sanjin.In January 2021, established collaboration and license agreement with Exelixis, Inc. (Exelixis). Under the terms of the agreement, Exelixis made an upfront payment of US$11 million to Adagene.In January 2021, extended the collaboration with the National Heart, Lung, and Blood Institute at the National Institutes of Health (NIH), to 2023. The extension of the NIH research collaboration agreement will enable the development of additional antibodies and therapeutic candidates. Expansion of Leadership Team and Recent Hires In March 2021, appointed Dr. Shi Wei as SVP of Clinical Development and Dr. Songmao Zheng as Associate Vice President of Research & Development. Shi Wei, M.D., Ph.D., is SVP of Clinical Development at Adagene. Prior to this role, she was Head of China Oncology Clinical Development; Early Oncology Pipeline at Amgen with a focus on solid tumors as well as hematologic malignancies. She has held leadership positions at Antengene, Covance, BioMarin Pharmaceuticals and Novartis.Songmao Zheng, Ph.D., is Associate Vice President of Research and Development at Adagene, leading quantitative model-informed drug discovery and development in both preclinical and clinical space. Prior to this role, he was Scientific Director/Group Leader leading numerous biologics programs at Janssen BioTherapeutics, Janssen R&D since 2013. The Company has further strengthened the clinical team and CMC team under the leadership of Hua Gong and Qinghai Zhao respectively. Successfully Completed Initial Public Offering In February 2021, Adagene completed a successful initial public offering (the “IPO”) of 8,457,100 American depositary shares ("ADSs"), at public offering price of US$19.00 per ADS. The number of ADSs issued at closing included the exercise in full of the underwriters’ option to purchase 1,103,100 additional ADSs from the Company. The aggregate gross proceeds from the IPO were approximately US$161 million, before deducting underwriting discounts and commissions and estimated offering expenses payable by the Company. Full-Year 2020 Financial Highlights Cash and Cash EquivalentsOur Cash and cash equivalents decreased by 19% from approximately US$92.5 million as of December 31, 2019 to approximately US$75.2 million as of December 31, 2020. The decrease in cash and cash equivalents was mainly due to increased cash outflows arising from operating activities. Moreover, Adagene successfully completed its IPO in February 2021, resulting in gross proceeds of approximately US$161 million. Net RevenueOur net revenue increased by 46% from US$0.5 million in 2019 to US$0.7 million in 2020. For the year ended December 31, 2019, we recognized revenue of US$0.5 million from Signal Pharmaceuticals LLC, a subsidiary of Celgene Corporation. For the year ended December 31, 2020, we recognized revenue of US$0.3 million, US$0.23 million and US$0.15 million from Signal Pharmaceuticals LLC, ADC Therapeutics SA and Tanabe Research Laboratories, Inc. respectively. As we have received US$11 million from Exelixis in March 2021, we expect that our net revenue for Year 2021 will be significantly higher than that of Year 2020. Research and Development Expenses Our research and development expenses increased by 107% from US$16.2 million in 2019 to US$33.5 million in 2020, primarily attributable to (i) an increase in payroll and other related costs of personnel due to headcount growth in research and development and increased share-based compensation expenses and (ii) an increase in costs related to preclinical testing and clinical trials due to progression of the programs and increased contract manufacturing costs. General and Administrative (G&A) Expenses Our administrative expenses increased by 200% from US$3.4 million in 2019 to US$10.3 million in 2020. The increase was primarily due to a rise in average payroll, an increase in the number of employees and increased share-based compensation expenses. Net LossOur net loss attributable to Adagene Inc.’s shareholders increased by 158% from approximately US$16.4 million in 2019 to approximately US$42.4 million in 2020. Non-GAAP Net Loss Non-GAAP net loss, which is defined as net loss attributable to ordinary shareholders for the period after excluding (i) share-based compensation expenses and (ii) accretion of convertible redeemable preferred shares to redemption value, increased by 104% from approximately US$15.8 million in 2019 to approximately US$32.3 million in 2020. Please refer to the section in this press release titled “Reconciliation of GAAP and Non-GAAP Results” for details. Non-GAAP Financial Measures The Company uses non-GAAP net loss and non-GAAP net loss per ordinary share for the year/period, which are non-GAAP financial measures, in evaluating its operating results and for financial and operational decision-making purposes. The Company believes that non-GAAP net loss and non-GAAP net loss per ordinary share for the year/period help identify underlying trends in the Company’s business that could otherwise be distorted by the effect of certain expenses that the Company includes in its loss for the year/period. The Company believes that non-GAAP net loss and non-GAAP net loss per ordinary share for the year/period provide useful information about its results of operations, enhance the overall understanding of its past performance and future prospects and allow for greater visibility with respect to key metrics used by its management in its financial and operational decision-making. Non-GAAP net loss and non-GAAP net loss per ordinary share for the year/period should not be considered in isolation or construed as an alternative to operating profit, loss for the year/period or any other measure of performance or as an indicator of its operating performance. Investors are encouraged to review non-GAAP net loss and non-GAAP net loss per ordinary share for the year/period and the reconciliation to their most directly comparable GAAP measures. Non-GAAP net loss and non-GAAP net loss per ordinary share for the year/period here may not be comparable to similarly titled measures presented by other companies. Other companies may calculate similarly titled measures differently, limiting their usefulness as comparative measures to the Company’s data. The Company encourages investors and others to review its financial information in its entirety and not rely on a single financial measure. Non-GAAP net loss and non-GAAP net loss per ordinary share for the year/period represent net loss attributable to ordinary shareholders for the year/period excluding (i) share-based compensation expenses, and (ii) accretion of convertible redeemable preferred shares to redemption value. Please see the “Reconciliation of GAAP and Non-GAAP Results”” included in this press release for a full reconciliation of non-GAAP net loss and non-GAAP net loss per ordinary share for the year/period for the year/period to net loss attributable to ordinary shareholders for the year/period. About Adagene Inc. Adagene Inc. (Nasdaq: ADAG) is a platform-driven, clinical-stage biopharmaceutical company committed to transforming the discovery and development of novel antibody-based cancer immunotherapies. Adagene combines computational biology and artificial intelligence to design novel antibodies that address unmet patient needs. Powered by its proprietary DPL platform, composed of NEObody, SAFEbody, and POWERbody technologies, Adagene’s highly differentiated pipeline features novel immunotherapy programs. Adagene has forged strategic collaborations with reputable global partners that leverage its technology in multiple approaches at the vanguard of science. For more information, please visit: https://investor.adagene.com. Safe Harbor Statement This press release contains forward-looking statements, including statements regarding the potential implications of clinical data for patients, and Adagene’s advancement of, and anticipated clinical development, regulatory milestones and commercialization of its product candidates. Actual results may differ materially from those indicated in the forward-looking statements as a result of various important factors, including but not limited to Adagene’s ability to demonstrate the safety and efficacy of its drug candidates; the clinical results for its drug candidates, which may not support further development or regulatory approval; the content and timing of decisions made by the relevant regulatory authorities regarding regulatory approval of Adagene’s drug candidates; Adagene’s ability to achieve commercial success for its drug candidates, if approved; Adagene’s ability to obtain and maintain protection of intellectual property for its technology and drugs; Adagene’s reliance on third parties to conduct drug development, manufacturing and other services; Adagene’s limited operating history and Adagene’s ability to obtain additional funding for operations and to complete the development and commercialization of its drug candidates; Adagene’s ability to enter into additional collaboration agreements beyond its existing strategic partnerships or collaborations, and the impact of the COVID-19 pandemic on Adagene’s clinical development, commercial and other operations, as well as those risks more fully discussed in the “Risk Factors” section in Adagene’s filings with the U.S. Securities and Exchange Commission. All forward-looking statements are based on information currently available to Adagene, and Adagene undertakes no obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events or otherwise, except as may be required by law. Consolidated Balance Sheets As of December 31 2019(audited) 2020 (unaudited) 2020(unaudited) US$ US$ US$ (Pro forma*) ASSETS Current assets: Cash and cash equivalents92,532,788 75,150,998 75,150,998 Short-term investments8,000,000 — — Accounts receivable, net480,000 — — Amounts due from related parties1,433,186 132,396 132,396 Prepayments and other current assets1,476,973 3,813,984 3,813,984 Total current assets103,922,947 79,097,378 79,097,378 Property, equipment and software, net1,879,325 2,067,125 2,067,125 Other non-current assets87,227 3,098,234 3,098,234 TOTAL ASSETS105,889,499 84,262,737 84,262,737 LIABILITIES, MEZZANINE EQUITY AND SHAREHOLDERS’ DEFICIT Current liabilities: Accounts payable712,714 1,809,975 1,809,975 Contract liabilities993,378 725,536 725,536 Amounts due to related parties1,895,779 2,535,358 2,535,358 Accruals and other current liabilities2,540,164 6,059,497 6,059,497 Short-term borrowings716,723 3,831,476 3,831,476 Current portion of long-term borrowings322,525 1,183,926 1,183,926 Total current liabilities7,181,283 16,145,768 16,145,768 Long-term borrowings1,515,868 2,965,563 2,965,563 Other non-current liabilities— 91,955 91,955 TOTAL LIABILITIES8,697,151 19,203,286 19,203,286 Commitments and contingencies LIABILITIES, MEZZANINE EQUITY AND SHAREHOLDERS’ DEFICIT (CONTINUED) Mezzanine equity: Series A-1 convertible redeemable preferred shares (par value of US$0.0001 per share; 5,473,957 and 5,473,957 shares authorized, issued and outstanding as of December 31, 2019 and 2020, respectively; and none outstanding on a pro-forma basis as of December 31, 2020)5,473,957 5,473,957 — Series A-2 convertible redeemable preferred shares (par value of US$0.0001 per share; 2,370,414 and 2,370,414 shares authorized, issued and outstanding as of December 31, 2019 and 2020, respectively; and none outstanding on a pro-forma basis as of December 31, 2020)3,000,000 3,000,000 — Series B convertible redeemable preferred shares (par value of US$0.0001 per share; 7,494,537 and 7,494,537 shares authorized, issued and outstanding as of December 31, 2019 and 2020, respectively; and none outstanding on a pro-forma basis as of December 31, 2020)27,999,995 27,999,995 — Series C-1 convertible redeemable preferred shares (par value of US$0.0001 per share; 5,597,354 and 5,597,354 shares authorized, issued and outstanding as of December 31, 2019 and 2020, respectively; and none outstanding on a pro-forma basis as of December 31, 2020)48,727,343 48,975,456 — Series C-2 convertible redeemable preferred shares (par value of US$0.0001 per share; 1,861,121 and 1,861,121 shares authorized, issued and outstanding as of December 31, 2019 and 2020, respectively; and none outstanding on a pro-forma basis as of December 31, 2020)18,999,999 18,999,999 — Series C-3 convertible redeemable preferred shares (par value of US$0.0001 per share; 4,452,441 and 4,452,441 shares authorized, issued and outstanding as of December 31, 2019 and 2020, respectively; and none outstanding on a pro-forma basis as of December 31, 2020)50,000,000 50,000,000 — Total mezzanine equity154,201,294 154,449,407 — Shareholders’ deficit: Ordinary shares (par value of US$0.0001 per share; 500,000,000 and 500,000,000 shares authorized; 15,193,136 shares issued and outstanding as of December 31, 2019; 18,888,070 shares issued and 16,603, 070 shares outstanding as of December 31, 2020; and 46,137,894 shares issued and 43,852,894 shares outstanding on a pro forma basis as of December 31, 2020)1,519 1,889 4,614 Subscriptions receivable from shareholders(197,068)(7,172,192)(7,172,192)Additional paid-in capital6,789,542 23,786,652 178,233,334 Accumulated other comprehensive loss(344,894)(350,981)(350,981)Accumulated deficit(63,258,045)(105,655,324)(105,655,324)Total shareholders’ deficit(57,008,946)(89,389,956)65,059,451 TOTAL LIABILITIES, MEZZANINE EQUITY AND SHAREHOLDERS’ DEFICIT105,889,499 84,262,737 84,262,737 * The unaudited pro forma balance sheet information as of December 31, 2020 assumes the automatic conversion of all of the outstanding convertible redeemable preferred shares into ordinary shares at a conversion ratio of 1:1, as if the conversion and expiry had occurred as of December 31, 2020. Consolidated Statements of Comprehensive Loss For the years endedDecember 31, 2019(audited) 2020(unaudited) US$ US$ Revenues Licensing revenue480,000 700,913 Expenses Research and development expenses(16,211,750)(33,538,035)Third parties(10,507,444)(23,645,740)Related parties(5,704,306)(9,892,295)Administrative expenses(3,437,900)(10,314,536)Loss from operations(19,169,650)(43,151,658)Interest income922,680 629,288 Interest expense(138,096)(202,165)Other income723,476 971,949 Foreign exchange gain, net21,867 (644,693)Change in fair value of warrant liabilities1,207,415 — Loss before income tax(16,432,308)(42,397,279)Income tax expense— — Net loss attributable to Adagene Inc.’s shareholders(16,432,308)(42,397,279)Other comprehensive income (loss) Foreign currency translation adjustments, net of nil tax65,799 (6,087)Total comprehensive loss attributable to Adagene Inc.’s shareholders(16,366,509)(42,403,366)Net loss attributable to Adagene Inc.’s shareholders(16,432,308)(42,397,279)Deemed contribution from convertible redeemable preferred shareholders— — Accretion of convertible redeemable preferred shares to redemption value(246,184)(248,113)Net loss attributable to ordinary shareholders(16,678,492)(42,645,392)Weighted average number of ordinary shares used in per share calculation: —Basic15,178,232 15,950,698 —Diluted15,178,232 15,950,698 Net loss per ordinary share —Basic(1.10)(2.67)—Diluted(1.10)(2.67) Reconciliation of GAAP and Non-GAAP Results For the years endedDecember 31, 2019 2020 US$ US$ GAAP Net loss attributable to ordinary shareholders(16,678,492)(42,645,392)Add back: Share-based compensation expenses 611,711 10,129,541 Accretion of convertible redeemable preferred shares to redemption value 246,184 248,113 Non-GAAP net loss(15,820,597)(32,267,738)Weighted average number of ordinary shares used in per share calculation: —Basic 15,178,232 15,950,698 —Diluted 15,178,232 15,950,698 Non-GAAP net loss per ordinary share —Basic (1.04)(2.02)—Diluted (1.04)(2.02) Investors Contact:Raymond TamAdagene86-512-8777-3626ir@adagene.com Bruce MackleLifeSci Advisors646-889-1200bmackle@lifesciadvisors.com Media Contact:Annie Starr6 Degrees973-768-2170astarr@6degreespr.com

    • Adagene Announces Clinical Advancement for ADG116
      GlobeNewswire

      Adagene Announces Clinical Advancement for ADG116

      -NEObody™ product candidate ADG116 has been well tolerated in ongoing Phase 1 clinical trial- -Promising pharmacodynamic biomarker signals demonstrate clinical proof of mechanism--Poised for global expansion- SAN FRANCISCO and SUZHOU, China, March 29, 2021 (GLOBE NEWSWIRE) -- Adagene Inc. (Nasdaq: ADAG), a platform-driven, clinical-stage biopharmaceutical company committed to transforming the discovery and development of novel antibody-based immunotherapies, today announced the interim dose-escalation data up to 0.3 mg/kg in its ongoing Phase 1 clinical trial in Australia evaluating the safety and tolerability of ADG116 in patients with advanced/metastatic solid tumors. ADG116 is a fully human, anti-CTLA-4 monoclonal antibody (mAb), designed to target a unique conserved epitope of CTLA-4 and utilizes Adagene’s proprietary NEObody platform technology. ADG116 is designed to balance safety and efficacy through a novel mechanism of action; ADG116 maintains its original physiological function via partial blocking of CTLA-4 ligand binding, and in conjunction, depletes Treg in the tumor microenvironment via strong antibody-dependent cellular cytotoxicity (ADCC). Interim data for the ongoing Phase 1 clinical trial: Safety: Analysis of all safety data generated to date demonstrates that ADG116 has been well-tolerated in more than 10 patients with no dose-limiting toxicities or unexpected safety signals. No drug related Grade 3 and Grade 4 toxicities have been observed.Notable findings in pharmacodynamics: A dose-dependent change in CD8+ and CD4+ TEM / Treg ratios, important pharmacodynamic (PD) biomarkers indicating immune activation, was observed for patients dosed by ADG116. In particular, a patient, refractory to prior pembrolizumab therapy (> 25 cycles), demonstrated striking increases in T and NK cells, and CD8+ and CD4+ TEM / Treg ratios. The Grade 1 treatment-related pruritus of this patient is a clinical symptom consistent with immune-mediated action of ADG116 treatment.Pharmacokinetics: The terminal half-life of ADG116 was within the normal range of IgG1 based antibodies.Clinical proof of mechanism: The Phase 1 dose escalation data demonstrates the clinical proof of mechanism for ADG116 in targeting CTLA-4, consistent with preclinical observations for the potency of ADG116 starting from 0.03 to 0.3 mg/kg. “We are encouraged by the positive PD marker signals and safety data,” said Peter Luo, Ph.D., Co-founder, Chief Executive Officer and Chairman of Adagene. “It is particularly striking to observe immune activation biomarkers at 0.03 mg/kg, especially in the patient refractory to prior pembrolizumab therapies. We believe ADG116 has the potential to overcome the limitations of anti-CTLA-4 checkpoint inhibitors, extending the market potential beyond current anti-CTLA-4 inhibitors in both monotherapy and combination settings. Our highly differentiated anti-CTLA-4 therapeutics hold the potential to improve the clinical benefits by expanding clonal diversity, infiltrating into cold tumors, and treating patients resistant/refractory to current immuno-therapies.” “We look forward to developing a comprehensive clinical program to evaluate each of our anti-CTLA-4 assets,” continued Dr. Luo. “We will leverage the modality-specific features demonstrated in the preclinical setting, that enable high-fidelity translation into the clinic by targeting unique, highly conserved epitope of CTLA-4 with broad species cross-reactivity. We remain committed to maximizing the full potential of our unique anti-CTLA-4 approach.” The progression of the Phase 1 dose-escalation trial to the 5th dose, a 0.3mg/kg dose level, builds on encouraging signs of PD markers, normal PK data, strong early clinical data, extensive preclinical and safety tolerability data and a successful Safety Review Committee meeting. Multiple clinical sites are currently open in Australia. In this ongoing Phase 1 clinical trial of ADG116 in patients with advanced/metastatic solid tumors, no dose-limiting toxicity (DLT), treatment-related serious adverse events (SAEs), colitis or hepatitis have been observed. With favorable clinical data to date, Adagene looks forward to expanding the ongoing global Phase 1 trial, with the acceptance of revised study protocol by FDA to expand the trial in the U.S. Adagene has also obtained confirmation from China NMPA to proceed with revised protocol submission at higher starting dose than that in the original submission. Additional information about this clinical trial is available at ClinicalTrials.gov using the identifier: NCT04501276. About ADG116 ADG116 is a fully human ligand-blocking anti-CTLA-4 mAb generated using NEObody technology. ADG116 is a differentiated anti-CTLA-4 approach, which leverages Adagene’s Dynamic Precision technology to target a conserved epitope with broad species cross-reactivity for translational fidelity and a unique CTLA-4 mechanism of action. In preclinical studies, ADG116 was observed to have softer CTLA-4 ligand blocking and stronger ADCC for depleting regulatory T-cells than ipilimumab. In a head-to-head in vivo efficacy study, ADG116 was observed to have at least a five-fold greater preclinical antitumor activity in comparison with ipilimumab. In preclinical studies, ADG116 was well tolerated in rats and cynomolgus monkeys in four-week repeat-dose GLP toxicology studies at doses up to 30 mg/kg, and demonstrated an encouraging antitumor response in multiple immune-competent mouse tumor models in a dose-dependent manner both as a single agent (showing initial response at 0.02mg/kg, and complete response at 0.1 mg/kg for tumor size of ~100mm3 in sensitive tumor models) and in combination with other therapies. About AdageneAdagene Inc. is a platform-driven, clinical-stage biopharmaceutical company committed to transforming the discovery and development of novel antibody-based cancer immunotherapies. Adagene combines computational biology and artificial intelligence to design novel antibodies that address unmet patient needs. Powered by its proprietary DPL platform, composed of NEObody, SAFEbody, and POWERbody technologies, Adagene’s highly differentiated pipeline features novel immunotherapy programs. Adagene has forged strategic collaborations with reputable global partners that leverage its technology in multiple approaches at the vanguard of science. For more information, please visit: https://investor.adagene.com. Safe Harbor StatementThis press release contains forward-looking statements, including statements regarding data from the ADG116 preclinical studies and Phase 1 clinical trial, the potential implications of clinical data for patients, and Adagene's advancement of, and anticipated clinical development, regulatory milestones, and commercialization of ADG116. Actual results may differ materially from those indicated in the forward-looking statements as a result of various important factors, including but not limited to Adagene's ability to demonstrate the safety and efficacy of its drug candidates; the clinical results for its drug candidates, which may not support further development or regulatory approval; the content and timing of decisions made by the relevant regulatory authorities regarding regulatory approval of Adagene's drug candidates; Adagene's ability to achieve commercial success for its drug candidates, if approved; Adagene's ability to obtain and maintain protection of intellectual property for its technology and drugs; Adagene's reliance on third parties to conduct drug development, manufacturing and other services; Adagene's limited operating history and Adagene's ability to obtain additional funding for operations and to complete the development and commercialization of its drug candidates; Adagene’s ability to enter into additional collaboration agreements beyond its existing strategic partnerships or collaborations, and the impact of the COVID-19 pandemic on Adagene's clinical development, commercial and other operations, as well as those risks more fully discussed in the "Risk Factors" section in Adagene's filings with the U.S. Securities and Exchange Commission. All forward-looking statements are based on information currently available to Adagene, and Adagene undertakes no obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events or otherwise, except as may be required by law. Investors ContactRaymond TamAdagene86-512-8777-3626ir@adagene.com Bruce Mackle LifeSci Advisors 646-889-1200 bmackle@lifesciadvisors.com Media ContactAnnie Starr6 Degrees973-768-2170astarr@6degreespr.com