1. SAN FRANCISCO, Calif. and SUZHOU, China, Sept. 02, 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 that Adagene's Co-founder, Chief Executive Officer and Chairman, Peter Luo, Ph.D., will participate in the Morgan Stanley 19th Annual Global Healthcare Conference to be held virtually September 9-15, 2021.

    Details on the presentation and Q&A can be found below:

    Date:Friday, September 10, 2021
    Time:2:00 p.m. Eastern

    A live webcast of the presentation will be accessible in the Investors section of the company's website at https://www.adagene.com. A webcast…

    SAN FRANCISCO, Calif. and SUZHOU, China, Sept. 02, 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 that Adagene's Co-founder, Chief Executive Officer and Chairman, Peter Luo, Ph.D., will participate in the Morgan Stanley 19th Annual Global Healthcare Conference to be held virtually September 9-15, 2021.

    Details on the presentation and Q&A can be found below:

    Date:Friday, September 10, 2021
    Time:2:00 p.m. Eastern

    A live webcast of the presentation will be accessible in the Investors section of the company's website at https://www.adagene.com. A webcast replay will be available for at least 30 days.

    About Adagene

    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 Dynamic Precision Library (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.

    Internal Contact:

    Ami Knoefler

    Adagene

    650-739-9952

    ir@adagene.com

    External Contact:

    Bruce Mackle

    LifeSci Advisors

    646-889-1200

    bmackle@lifesciadvisors.com

     



    Primary Logo

    View Full Article Hide Full Article
  2. - Established three clinical collaborations with Merck to conduct global combination trials with pembrolizumab for three clinical-stage oncology candidates -

    - Evidence of ADG106 efficacy with favorable safety profile shown in monotherapy trials; combination trials ramping up to target biomarker-enriched indications and PD-1 resistant patients -

    - Strong potential for differentiated profile of novel NEObody™ anti-CTLA-4 candidate, ADG116, demonstrated in ongoing phase 1 trial -

    - First SAFEbody™ program, ADG126, advancing in phase 1 dose-escalation -

    - Continued execution of multiple preclinical programs towards IND, leveraging the company's powerful antibody-based technology platforms -

    - Further strengthened leadership team and expanded

    - Established three clinical collaborations with Merck to conduct global combination trials with pembrolizumab for three clinical-stage oncology candidates -

    - Evidence of ADG106 efficacy with favorable safety profile shown in monotherapy trials; combination trials ramping up to target biomarker-enriched indications and PD-1 resistant patients -

    - Strong potential for differentiated profile of novel NEObody™ anti-CTLA-4 candidate, ADG116, demonstrated in ongoing phase 1 trial -

    - First SAFEbody™ program, ADG126, advancing in phase 1 dose-escalation -

    - Continued execution of multiple preclinical programs towards IND, leveraging the company's powerful antibody-based technology platforms -

    - Further strengthened leadership team and expanded network of scientific and strategic advisors to develop best-in-class pipeline -

    SAN FRANCISCO and SUZHOU, China, Aug. 26, 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 six months ended June 30, 2021, and provided corporate updates.

    "During the first half of 2021, we advanced our clinical pipeline of three highly differentiated immuno-oncology candidates, while building a robust pipeline of novel preclinical programs that leverage our unique computational biology and artificial intelligence (AI) powered technology platforms," said Peter Luo, Ph.D., Co-founder, Chief Executive Officer and Chairman of Adagene. "With three Merck collaborations now in place, we've refined our global clinical development strategies to enhance efficiency and optimize our plans moving forward, while we anticipate key upcoming data from ongoing trials. Our pipeline aims to transform cancer therapy with the first of a new class of agonist antibodies targeting CD137, as well as new modalities and novel combinations to unlock the value of CTLA-4 as a proven target and the backbone of future immunotherapies. Applying our unique technology platforms and translational expertise, our goal is to strike a balance between safety and efficacy, addressing the core challenge of oncology drug development."

    Recent Highlights and Upcoming Milestones  

    ADG106: This NEObody™ program is a fully human ligand-blocking, agonistic anti-CD137 IgG4 monoclonal antibody (mAb) that is being evaluated in patients with advanced solid tumors and/or non-Hodgkin's lymphoma.

    • Evaluated ADG106 in 98 patients in phase 1 monotherapy dose escalation trials in U.S. (ADG106-1001) and China (ADG106-1002):  
      • ADG106 monotherapy was well tolerated at doses of 3 mg/kg and 5 mg/kg. Limited treatment emergent adverse events were observed (i.e., limited liver toxicity or hematologic abnormalities). Results showed evidence of efficacy with a 56% disease control rate, and more than 30% tumor shrinkage was observed in 75% of patients with positive biomarker expression (via retrospective analysis), including a partial response evaluated by RECIST v1.1 in a patient with a solid tumor who failed multiple prior therapies.
      • Data from these trials were published at the ASCO 2021 Annual Meeting.
    • Continued dose escalation in a phase 1b/2 trial (ADG106-1008) evaluating safety and preliminary efficacy of ADG106 in combination with toripalimab, an approved anti-PD-1 in China. This trial is targeting biomarker-enriched tumors in patients who failed prior standard and/or immuno-oncology therapies.
      • Preliminary data from this trial demonstrate target engagement as shown by a dose-dependent pharmacodynamic biomarker, consistent with the monotherapy trials.
    • Implementing a biomarker-enriched tumor targeting strategy for a phase 1b/2 trial of ADG106 in combination with pembrolizumab (ADG106-P2001; KEYNOTE-D12) in the U.S. and Asia Pacific (APAC), integrating earlier plans for the ADG106-2001 trial. Data from this trial are expected in 2022.
    • Upcoming ADG106 milestones:
      • H2 2021
        • Results from ongoing trial in combination with toripalimab (ADG106-1008)
        • Complete patient follow up in monotherapy trials in the U.S. (ADG106-1001) and China (ADG106-1002)
      • 2022
        • Results from combination trial with pembrolizumab (ADG106-P2001)

    ADG116: This NEObody program, targeting a unique epitope of CTLA-4, is being evaluated in patients with advanced/metastatic solid tumors. ADG116 is designed to enhance efficacy by potent Treg depletion in the tumor microenvironment (TME) and to maintain its physiological function by soft ligand blocking in order to address safety concerns associated with existing CTLA-4 therapeutics.

    • Continued dose escalation in a global phase 1 clinical trial evaluating the safety and tolerability of ADG116 in patients with advanced/metastatic solid tumors (ADG116-1003):
      • ADG116 has shown no dose-limiting toxicities at doses up to 6 mg/kg, which is twice the 3 mg/kg dose level approved for the commercially available CTLA-4 therapy in specific indications. Dosing at 10 mg/kg is being initiated. 
      • This trial is on track to be expanded this year with two combination cohorts investigating safety and preliminary efficacy of ADG116 with either toripalimab or ADG106 in patients with advanced/metastatic solid tumors, integrating earlier plans for the ADG106-1003 trial.
    • Obtained approval of Investigational New Drug application (IND) from China's National Medical Products Administration (NMPA) for a phase 1 monotherapy trial in China (ADG116-1002).
    • On track to advance a phase 1 trial of ADG116 in combination with pembrolizumab (ADG116-P001; KEYNOTE C97) in the U.S. and APAC in 2022.
    • Upcoming ADG116 milestones:
      • H2 2021
        • Results from ongoing dose escalation of ADG-116 monotherapy (ADG116-1003)
      • 2022
        • Results from ongoing dose escalation of combination cohorts, including the combination of ADG116 with toripalimab and ADG106 (ADG116-1003), respectively
        • Results from combination trial with pembrolizumab (ADG116-P001)

    ADG126: The SAFEbody™ program targets CTLA-4 with a compelling preclinical profile and is designed to provide enhanced safety. ADG126 is designed for conditional activation in the TME, as well as to enhance efficacy by potent Treg depletion and to maintain its physiological function by soft ligand blocking in order to expand the therapeutic index and further address safety concerns with existing CTLA-4 therapies.

    • Continued dose escalation in a global phase 1 clinical trial evaluating the safety and tolerability of ADG126 in patients with advanced/metastatic solid tumors (ADG126-1001).
    • In April 2021, presented an update on preclinical data at the AACR Annual Meeting. Preclinical data demonstrated ADG126 was well tolerated at doses up to 200 mg/kg, with 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.
    • Submitted IND to NMPA for a phase 1, dose-escalation and cohort expansion trial of ADG126 in China as monotherapy, and in combination with toripalimab, to evaluate safety and preliminary efficacy in patients with advanced/metastatic solid tumors (ADG126-1002).
    • On track to advance a phase 1 trial of ADG126 in combination with pembrolizumab (ADG126-P001; KEYNOTE-C98) in the U.S. and APAC in 2022.
    • Upcoming ADG126 milestones:
      • H2 2021
        • Results from ongoing dose escalation of ADG126 monotherapy (ADG126-1001)  
      • 2022
        • Results from dose escalation and cohort expansion of ADG126 (ADG126-1002)
        • Results from combination trial with pembrolizumab (ADG126-P001)

    Preclinical Discovery Programs: The company continues to expand and advance a pipeline of innovative preclinical programs leveraging its NEObody, SAFEbody and/or POWERbody™ technologies to support the goal of submitting more than ten INDs or equivalent applications in the next three to five years.

    • Currently, five programs utilizing POWERbody and SAFEbody technologies are undergoing IND-enabling studies, including a highly differentiated anti-CD47 program, and bispecific T-cell engager programs that target both liquid and solid tumors.
    • All five programs have a robust Chemistry, Manufacturing and Controls (CMC) profile with encouraging preclinical safety and efficacy data.
    • Since March 31, 2021, the company has advanced two additional programs into CMC activity, further enhancing its portfolio of future IND candidates.
    • Upcoming preclinical discovery milestones:
      • 2021
        • Continue advancement of multiple candidates undergoing IND-enabling studies
      • 2022
        • Submission of multiple INDs or equivalent to advance innovative candidates from the company's deep, broad, and differentiated preclinical discovery pipeline

    Collaborations:

    • Established clinical trial collaboration and supply agreements with Merck for all three clinical candidates:
      • In July 2021, Adagene entered into two clinical collaborations with Merck, a leader in immuno-oncology. The collaborations include two open-label, dose escalation and expansion clinical studies to evaluate Adagene's anti-CTLA-4 mAb product candidates, ADG116 and ADG126, in combination with pembrolizumab for patients with advanced/metastatic solid tumors, respectively.
      • In August 2021, Adagene entered into a third clinical collaboration with Merck to evaluate ADG106 in combination with pembrolizumab in advanced or metastatic solid and/or hematological malignancies.
    • Advanced the company's ongoing collaboration with Guilin Sanjin Pharmaceutical Co., Ltd., or Sanjin, and its affiliates to develop two different monoclonal antibodies:
      • ADG104, an anti-PD-L1 monoclonal antibody, demonstrated promising data in ongoing phase 1b and phase 2 clinical trials concurrently in China. As of June 30, 2021, 4 patients had partial responses, 16 had stable disease, and a disease control rate of 50% was observed in 40 evaluable patients with various tumor types who received ADG104 monotherapy.
      • The second program, an anti-CSF-1R monoclonal antibody, received IND approval from the NMPA in March, and a phase 1 trial is expected to initiate dosing soon.

    Corporate Updates

    • The company announced, effective immediately, a change in composition of the board of directors (the "Board") of Adagene Inc. Mr. Yu Miao, a director designated by JSR Limited pursuant to the current effective shareholders agreement, has resigned from the Board due to personal reasons. Mr. Miao confirms that he has no disagreement with the company. Adagene is appreciative of Mr. Miao for his service and valuable contributions to the Board.
    • The company has further strengthened its leadership team with recent hires across functions:
      • Steve Fischkoff, M.D., was appointed as interim Chief Medical Officer of Adagene. Dr. Fischkoff is a board-certified medical oncologist who has been active in the pharmaceutical industry for approximately 30 years. Previously, while at Medarex, Dr. Fischkoff led the clinical development of Yervoy® (ipilumumab), the first checkpoint inhibitor and the only anti-CTLA-4 product approved by the U.S. Food and Drug Administration. He also served as the clinical lead from first-in-human through submission and approval in the U.S. and the EU of Humira® (adalimumab), the world's top selling pharmaceutical product, at Knoll Pharmaceuticals and Abbott Laboratories.
      • Jin Shang, Ph.D., was appointed as Senior Vice President of Global Regulatory Affairs. Dr. Shang brings more than 20 years of research, drug development and regulatory experience in the biopharmaceutical industry and most recently served as Director of Regulatory Affairs, Oncology at AstraZeneca, and previously held positions at Sun Pharma, Morphic Therapeutic, and Merck.
      • Wenlin Zeng, Ph.D., was appointed as Vice President of Cell Line and Upstream. Dr. Zeng will manage cell line and upstream process development, as well as oversee subsequent manufacturing of biological products. Dr Zeng brings more than 20 years of experience in cell line development, cGMP cell banking and drug substance manufacturing. She most recently served as Senior Director at Gilead and previously held positions at Forty-Seven, NGM Bio, Advanced Bioscience Laboratories, GlaxoSmithKline, MedImmune Vaccines, Abgenix and Scios.
      • Ami C. Knoefler was appointed as Vice President of Investor Relations and Corporate Communications. She has more than 25 years of global experience in pharmaceutical, biotech and medical technology communications. She most recently served as Senior Director at Ascendis Pharma, and previously held positions at Jazz Pharmaceuticals, PDL BioPharma, Abgenix and Bristol-Myers Squibb. 
    • Expanded the Scientific and Strategic Advisory Board (SAB) to include pioneers in the immuno-oncology field: Steve Fischkoff, M.D., Stanley Frankel, M.D., FACP and Robert Spiegel, M.D., FACP. Adagene's SAB is comprised of industry leaders who have played a key role in the field of immuno-oncology. The SAB will work cohesively with management and other key advisors to provide strategic input as the company pursues global clinical development of its transformative, expanding pipeline.
    • In July, Adagene authorized a share repurchase program under which the Company may repurchase up to US$20 million of its ordinary shares in the form of American depositary shares.

    Financial Highlights

    Cash and Cash Equivalents

    Cash and cash equivalents were US$208.3 million as of June 30, 2021, compared to US$75.2 million as of December 31, 2020. The increase was mainly due to net proceeds of US$145.9 million from the company's Initial Public Offering in February 2021. In addition, in March 2021, Adagene received US$11.0 million from Exelixis, Inc., as per the terms of the collaboration and license agreement.

    Prepayments and Other Current Assets

    Prepayments and other current assets were US$5.4 million as of June 30, 2021, compared to US$3.8 million as of December 31, 2020. The increase was driven by expanded R&D activities and associated advanced payments made.

    Contract Liabilities

    Contract liabilities were US$11.1 million as of June 30, 2021, compared to US$0.7 million as of December 31, 2020. The increase was due to the collaboration and license agreement signed with Exelixis as the related performance obligations have not been fulfilled.

    Net Revenue

    Net revenue was US$1.4 million for the six months ended June 30, 2021, compared to US$0.3 million for the same period in 2020. The increase was due to a payment of US$1.2 million from Dragon Boat Pharmaceuticals, a subsidiary of Sanjin, related to fulfillment of performance obligations associated with the companies' collaboration to develop antibody-based therapies.

    Research and Development Expenses

    Research and development expenses were US$31.5 million for the six months ended June 30, 2021, compared to US$14.9 million for the same period in 2020. The increase was primarily attributable to an (i) increase in payroll and other related personnel costs by US$4.3 million due to headcount growth and average payroll increase in research and development, (ii) increase in non-cash share-based compensation expenses by US$3.1 million, and (iii) increase in costs related to preclinical testing and clinical trials due to progression of the programs and increased contract manufacturing costs by US$8.0 million. Adagene incurred US$16.6 million for project ADG106, ADG116 and ADG126 for the six months ended June 30, 2021, compared to US$13.0 million for the same period in 2020. Besides, Adagene incurred US$14.8 million for preclinical product candidates, research pipeline and others for the six months ended June 30, 2021, compared to US$1.9 million for the same period in 2020.

    General and Administrative (G&A) Expenses

    G&A expenses were US$7.4 million for the six months ended June 30, 2021, compared to US$4.7 million for the same period in 2020. The increase was primarily due to an (i) increase in headcount and average payroll and (ii) increase in professional fees and office expenses.

    Net Loss

    The net loss attributable to Adagene Inc.'s shareholders was US$37.2 million for the six months ended June 30, 2021, compared to US$18.2 million for the six months ended June 30, 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 was US$27.0 million for the six months ended June 30, 2021, compared to US$11.1 million for the six months ended June 30, 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 shares 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 shares 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 shares for the year/period provide useful information about its results of operations, enhances the overall understanding of its past performance and future prospects and allows 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 shares 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 shares 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 shares 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 shares 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. Share-based compensation expense is a non-cash expense arising from the grant of stock-based awards to employees. The Company believes that the exclusion of share-based compensation expenses from the net loss in the Reconciliation of GAAP and Non-GAAP Results assists management and investors in making meaningful period-to-period comparisons in the Company's operating performance or peer group comparisons because (i) the amount of share-based compensation expenses in any specific period may not directly correlate to the Company's underlying performance, (ii) such expenses can vary significantly between periods as a result of the timing of grants of new stock-based awards, and (iii) other companies may use different forms of employee compensation or different valuation methodologies for their share-based compensation.

    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 shares for the year/period for the year/period to net loss attributable to ordinary shareholders for the year/period.

    About Adagene

    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 preclinical activities, 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.

    Internal Contact:

    Ami Knoefler

    Adagene

    650-739-9952

    ir@adagene.com

    External Contact:

    Bruce Mackle

    LifeSci Advisors

    646-889-1200

    bmackle@lifesciadvisors.com

    FINANCIAL TABLES FOLLOW



    Unaudited Consolidated Balance Sheets

      As of

    December 31, 2020

    (audited) 
     As of

    June 30, 2021 
      US$  US$ 
    ASSETS      
    Current assets:      
    Cash and cash equivalents 75,150,998  208,274,215 
    Accounts receivable, net   619,185 
    Amounts due from related parties 132,396  928,408 
    Prepayments and other current assets 3,813,984  5,387,310 
    Total current assets 79,097,378  215,209,118 
    Property, equipment and software, net 2,067,125  2,593,357 
    Other non-current assets 3,098,234  59,569 
    TOTAL ASSETS 84,262,737  217,862,044 
    LIABILITIES, MEZZANINE EQUITY AND SHAREHOLDERS' DEFICIT      
    Current liabilities:      
    Accounts payable 1,809,975  2,833,974 
    Contract liabilities 725,536  11,100,000 
    Amounts due to related parties 2,535,358  6,411,083 
    Accruals and other current liabilities 6,059,497  3,558,332 
    Short-term borrowings 3,831,476  3,854,429 
    Current portion of long-term borrowings 1,183,926  1,818,857 
    Total current liabilities 16,145,768  29,576,675 
    Long-term borrowings 2,965,563  2,000,743 
    Other non-current liabilities 91,955  61,919 
    TOTAL LIABILITIES 19,203,286  31,639,337 

    Unaudited Consolidated Balance Sheets (Continued)

      As of

    December 31, 2020

    (audited)
     As of

    June 30, 2021
      US$  US$ 
    Mezzanine equity:      
    Series A-1 convertible redeemable preferred shares (par value of US$0.0001 per share; 5,473,957 shares authorized, issued and outstanding as of December 31, 2020, and none outstanding as of June 30, 2021 respectively) 5,473,957   
    Series A-2 convertible redeemable preferred shares (par value of US$0.0001 per share; 2,370,414 shares authorized, issued and outstanding as of December 31, 2020, and none outstanding as of June 30, 2021 respectively) 3,000,000   
    Series B convertible redeemable preferred shares (par value of US$0.0001 per share; 7,494,537 shares authorized, issued and outstanding as of December 31, 2020, and none outstanding as of June 30, 2021 respectively) 27,999,995   
    Series C-1 convertible redeemable preferred shares (par value of US$0.0001 per share; 5,597,354 shares authorized, issued and outstanding as of December 31, 2020, and none outstanding as of June 30, 2021 respectively) 48,975,456   
    Series C-2 convertible redeemable preferred shares (par value of US$0.0001 per share; 1,861,121 shares authorized, issued and outstanding as of December 31, 2020, and none outstanding as of June 30, 2021 respectively) 18,999,999   
    Series C-3 convertible redeemable preferred shares (par value of US$0.0001 per share; 4,452,441 shares authorized, issued and outstanding as of December 31, 2020, and none outstanding as of June 30, 2021 respectively) 50,000,000   
    Total mezzanine equity 154,449,407   
    Shareholders' deficit:      
    Ordinary shares (par value of US$0.0001 per share; 640,000,000 and 640,000,000 shares authorized; 18,888,070 shares issued and 16,603, 070 shares outstanding as of December 31, 2020; and 56,415,883 shares issued and 54,470,883 shares outstanding as of June 30, 2021) 1,889  5,642 
    Subscriptions receivable from shareholders (7,172,192)  
    Additional paid-in capital 23,786,652  329,216,570 
    Accumulated other comprehensive income (loss) (350,981) (153,498)
    Accumulated deficit (105,655,324) (142,846,007)
    Total shareholders' equity (deficit) (89,389,956) 186,222,707 
    TOTAL LIABILITIES, MEZZANINE EQUITY AND SHAREHOLDERS' EQUITY (DEFICIT) 84,262,737  217,862,044 
           



    Unaudited Consolidated Statements of Comprehensive Loss

      For the

    Six Months Ended

    June 30, 2020
     For the

    Six Months Ended

    June 30, 2021
      US$  US$ 
    Revenues      
    Licensing and collaboration revenue 309,500  1,358,836 
    Expenses      
    Research and development expenses (14,913,987) (31,462,546)
    Administrative expenses ( 4,733,496) (7,400,123)
    Loss from operations (19,337,983) (37,503,833)
    Interest income 523,557  69,332 
    Interest expense   (192,866)
    Other income, net 629,672  822,837 
    Foreign exchange gain (loss), net (592) (386,153)
    Loss before income tax (18,185,346) (37,190,683)
    Income tax expense    
    Net loss attributable to Adagene Inc.'s shareholders (18,185,346) (37,190,683)
    Other comprehensive income (loss)      
    Foreign currency translation adjustments, net of nil tax 39,829  197,483 
    Total comprehensive loss attributable to Adagene Inc.'s shareholders  (18,145,517) (36,993,200)
    Net loss attributable to Adagene Inc.'s shareholders (18,185,346) (37,190,683)
    Deemed contribution from convertible redeemable preferred shareholders    
    Accretion of convertible redeemable preferred shares to redemption value (123,221) (28,553)
    Net loss attributable to ordinary shareholders  (18,308,567) (37,219,236)
    Weighted average number of ordinary shares used in per share calculation:      
    —Basic 15,948,252  45,514,701 
    —Diluted 15,948,252  45,514,701 
    Net loss per ordinary share      
    —Basic (1.15) (0.82)
    —Diluted (1.15) (0.82)
           



    Reconciliation of GAAP and Non-GAAP Results

      For the

    Six Months Ended

    June 30, 2020
     For the

    Six Months Ended

    June 30, 2021
      US$  US$ 
    GAAP net loss attributable to ordinary shareholders (18,308,567) (37,219,236)
    Add back:      
    Share-based compensation expenses 7,093,006  10,152,791 
    Accretion of convertible redeemable preferred shares to redemption value 123,221  28,553 
    Non-GAAP net loss (11,092,340) (27,037,892)
    Weighted average number of ordinary shares used in per share calculation:      
    —Basic 15,948,252  45,514,701 
    —Diluted 15,948,252  45,514,701 
    Non-GAAP net loss per ordinary share      
    —Basic (0.70) (0.59)
    —Diluted (0.70) (0.59)


    Primary Logo

    View Full Article Hide Full Article
  3. SAN FRANCISCO, Aug. 19, 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 that it has entered into a third clinical trial collaboration and supply agreement with Merck (known as "MSD" outside the United States and Canada). The agreement includes an open-label, dose escalation and expansion clinical study of ADG106 in combination with Merck's anti-PD-1 KEYTRUDA® (pembrolizumab) in advanced or metastatic solid and/or hematological malignancies (ADG106-P2001/KEYNOTE-D12). This clinical study builds on the promising monotherapy and combination therapy data from…

    SAN FRANCISCO, Aug. 19, 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 that it has entered into a third clinical trial collaboration and supply agreement with Merck (known as "MSD" outside the United States and Canada). The agreement includes an open-label, dose escalation and expansion clinical study of ADG106 in combination with Merck's anti-PD-1 KEYTRUDA® (pembrolizumab) in advanced or metastatic solid and/or hematological malignancies (ADG106-P2001/KEYNOTE-D12). This clinical study builds on the promising monotherapy and combination therapy data from a Phase I trial of ADG106. Engineered using Adagene's proprietary NEObody™ platform technology, ADG106 is a fully human, ligand-blocking, agonistic anti-CD137 immunoglobulin G4 (IgG4) monoclonal antibody (mAb).

    "We are excited to continue our partnership with Merck in a third clinical collaboration that now combines our anti-CD137 agonist, ADG106, with KEYTRUDA," said Peter Luo, Ph.D., Co-founder, Chief Executive Officer and Chairman of Adagene. "While PD-1 drugs have advanced the cancer treatment paradigm, there are still a substantial number of patients with advanced metastatic solid and hematological malignancies who either relapse or are unresponsive, highlighting the need for new approaches. ADG106 targets a unique and highly conserved epitope with a novel mechanism of action and broad species cross reactivity, which enables testing in immunocompetent hosts. In multiple syngeneic models, we have shown a strong additive effect between ADG106 and anti-PD-1/PD-L1 agents."

    "We look forward to working closely with Merck and combining ADG106 with KEYTRUDA," said Steven Fischkoff, M.D., interim Chief Medical Officer of Adagene. "Together with our novel mechanism of action, extensive preclinical and strong clinical data generated to date, we believe ADG106 is an ideal candidate to combine with an anti-PD1 antibody to potentially create a new therapeutic option for cancer patients with unmet medical needs."

    KEYTRUDA® is a registered trademark of Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., Kenilworth, NJ, USA.

    About ADG106

    ADG106, is a fully human ligand-blocking, agonistic anti-CD137 IgG4 mAb being developed for the treatment of advanced solid tumors and non-Hodgkin's lymphoma. CD137 stimulates the immune system to attack cancer cells and is a key driver for long-lasting T cell proliferation and survival. In preclinical studies, we observed that ADG106 had robust antitumor activity and was well tolerated as a single agent and in combination with the existing standard-of-care and other immuno-oncology therapies. ADG106 activates CD137 in a native ligand-like fashion, blocks reverse CD137 ligand signaling, and induces potent cross-linking by Fc receptors. Because of this novel mechanism of action, ADG106 was observed to favorably balance CD137 agonism over CD137-induced liver toxicity, which we believe has potential to address the limitations of other existing anti-CD137 therapies.

    ADG106 Phase I trials have been successfully completed with enrollment of nearly 100 patients with advanced solid tumors and non-Hodgkin's lymphoma in the United States and China. Based on the promising Phase I data, ADG106 is being evaluated in a Phase Ib/II combination study in advanced solid tumors and relapsed/refractory non-Hodgkin lymphoma.

    About Adagene

    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 therapeutic potential of ADG106 in combination with pembrolizumab to treat patients with advanced/metastatic solid and/or hematological malignancies, data from the ADG106 clinical trials, clinical development plans of ADG106, the potential implications of clinical data for patients, and Adagene's advancement of, and anticipated clinical development, regulatory milestones and commercialization of ADG106. 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 the potential failure of the combination of ADG106 and pembrolizumab to demonstrate safety and/or efficacy in the Phase 1 open-label, dose escalation and expansion studies; the clinical results for Adagene's 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.

    Internal Contact:

    Ami Knoefler

    Adagene

    650-739-9952

    ir@adagene.com

    External Contact:

    Bruce Mackle

    LifeSci Advisors

    646-889-1200

    bmackle@lifesciadvisors.com



    Primary Logo

    View Full Article Hide Full Article
  4. SAN FRANCISCO, Calif. and SUZHOU, China, Aug. 12, 2021 (GLOBE NEWSWIRE) -- Adagene Inc. ("Adagene" or the "Company") (NASDAQ:ADAG), a platform-driven, clinical-stage biopharmaceutical company committed to transforming the discovery and development of novel antibody-based immunotherapies, today announced appointment of an interim Chief Medical Officer and new members of its Scientific and Strategic Advisory Board (the "SAB"). The appointments include pioneers in the immuno-oncology field: Steven Fischkoff, M.D., Stanley Frankel, M.D., FACP and Robert Spiegel, M.D., FACP.

    "We are honored to have such a prestigious group with deep therapeutics development experience to join our efforts in bringing transformative new cancer therapeutics to patients…

    SAN FRANCISCO, Calif. and SUZHOU, China, Aug. 12, 2021 (GLOBE NEWSWIRE) -- Adagene Inc. ("Adagene" or the "Company") (NASDAQ:ADAG), a platform-driven, clinical-stage biopharmaceutical company committed to transforming the discovery and development of novel antibody-based immunotherapies, today announced appointment of an interim Chief Medical Officer and new members of its Scientific and Strategic Advisory Board (the "SAB"). The appointments include pioneers in the immuno-oncology field: Steven Fischkoff, M.D., Stanley Frankel, M.D., FACP and Robert Spiegel, M.D., FACP.

    "We are honored to have such a prestigious group with deep therapeutics development experience to join our efforts in bringing transformative new cancer therapeutics to patients worldwide," said Peter Luo, Ph.D., Co-Founder, Chief Executive Officer and Chairman of the Board of Adagene. "This team has spearheaded some of the original immunotherapies, and their strategic vision adds tremendous value to Adagene as we design global development programs to maximize the potential of our robust pipeline. We are fortunate to work with these talented individuals in leveraging our innovative antibody-based technology platforms to usher in the next generation of immuno-oncology treatments."

    The new appointments include:

    • Steven Fischkoff, M.D. - Dr. Fischkoff serves as the interim Chief Medical Officer of Adagene and is a member of the company's SAB. He is a board-certified medical oncologist who has been active in the pharmaceutical industry for approximately 30 years. Previously, while at Medarex, Dr. Fischkoff led the clinical development of Yervoy® (ipilimumab), the first checkpoint inhibitor and the only anti-CTLA-4 product approved by the U.S. Food and Drug Administration ("FDA"). He also led development of Humira® (adalimumab), the world's top selling pharmaceutical product, from first-in-man through submission and approval in the U.S. and the EU at Knoll Pharmaceuticals and Abbott Laboratories.



    • Stanley Frankel, M.D., FACP - Dr. Frankel joins the SAB as a hematologist-oncologist with over 20 years of industry experience, including the research, clinical development, and commercialization of immuno-oncology and cellular therapies. He served as Corporate Vice-President Immuno-Oncology at Celgene where he oversaw the clinical development collaborations for the Medimmune/AstraZeneca alliance for durvalumab, and Celgene's alliances with BeiGene for tislelizumab and with Juno Therapeutics to develop cell-based therapies. He served as Senior Vice-President, Global Drug Development for Cell Therapy at BMS following the acquisition of Celgene to oversee the filing and development of Breyanzi® (lisocabtagene maraleucel) and Abecma® (idecabtagene vicleucel). Previously, he oversaw T-cell engager bispecific antibody development as Vice President, Clinical Development at Micromet including development of Blincyto® (blinatumomab). He is Chief Medical Officer at Cytovia Therapeutics and is a Non-Executive Director at Precision Biosciences. He serves on the Scientific Advisory Board at Sutro Biopharma, Immunai, and Minerva Biotechnologies. Dr. Frankel is also an Adjunct Associate Professor of Medicine at the Vagelos College of Physicians and Surgeons at Columbia University, New York.



    • Robert Spiegel, M.D., FACP - Dr. Spiegel joins the SAB with over 30 years of extensive R&D and operational experience in biopharmaceuticals and as an advisor to venture capital and private equity firms. Following a fellowship at the National Institutes of Health in medical oncology, Dr. Spiegel was the Director of Translational Medicine at NYU Cancer Center and then spent over 25 years at Schering-Plough (now Merck & Co.) where he joined as the first Director for Oncology Clinical Research, and subsequently held a series of senior executive positions, including Chief Medical Officer. He led the development of Temodar® (temozolomide) and Remicade® (infliximab) and was involved with approval of over 30 New Drug Applications by the FDA. Dr. Spiegel has been a consultant to the biotech industry and has served on the scientific advisory board and board of directors of multiple biotech companies.

    Adagene's SAB is comprised of leaders who have played a key role in the field of immuno-oncology.



    The SAB will work cohesively with management and other key advisors to provide strategic input as the company pursues global clinical development of its transformative, expanding pipeline.

    For more information about members of the scientific advisory board, visit: https://www.adagene.com/about/key-advisors/

    About Adagene

    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 announcement contains forward-looking statements within the meaning of federal securities laws, including statements regarding business plans, which involve risks and uncertainties that could cause the actual results to differ materially from the anticipated results and expectations expressed in these forward-looking statements. These statements are made under the "safe harbor" provisions of the U.S. Private Securities Litigation Reform Act of 1995. Statements that are not historical facts, including statements about the Company's beliefs and expectations, are forward-looking statements. Forward-looking statements involve inherent risks and uncertainties, and a number of factors could cause actual results to differ materially from those contained in any forward-looking statement. In some cases, forward-looking statements can be identified by words or phrases such as "may", "will," "expect," "anticipate," "target," "aim," "estimate," "intend," "plan," "believe," "potential," "continue," "is/are likely to" or other similar expressions. Further information regarding these and other risks, uncertainties or factors is included in the Company's filings with the SEC. All information provided in this press release is as of the date of this press release, and the Company does not undertake any duty to update such information, except as required under applicable law.

    Internal Contact:

    Ami Knoefler

    Adagene

    650-739-9952

    ir@adagene.com

    External Contact:

    Bruce Mackle

    LifeSci Advisors

    646-889-1200

    bmackle@lifesciadvisors.com 



    Primary Logo

    View Full Article Hide Full Article
  5. SAN FRANCISCO, July 22, 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 that it has entered into the clinical trial collaboration and supply agreement with Merck (known as "MSD" outside the United States and Canada), the leader among top immuno-oncology (IO) drugs on the market. The agreement includes two open-label, dose escalation and expansion clinical studies to evaluate Adagene's anti-CTLA-4 monoclonal antibody (mAb) product candidates, ADG116 and ADG126, in combination with Merck's anti-PD-1 therapy, KEYTRUDA® (pembrolizumab), for patients with advanced/metastatic…

    SAN FRANCISCO, July 22, 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 that it has entered into the clinical trial collaboration and supply agreement with Merck (known as "MSD" outside the United States and Canada), the leader among top immuno-oncology (IO) drugs on the market. The agreement includes two open-label, dose escalation and expansion clinical studies to evaluate Adagene's anti-CTLA-4 monoclonal antibody (mAb) product candidates, ADG116 and ADG126, in combination with Merck's anti-PD-1 therapy, KEYTRUDA® (pembrolizumab), for patients with advanced/metastatic solid tumors.

    "This collaboration with Merck and the advancement of our global clinical studies represent an important milestone in our comprehensive CTLA-4 clinical development program," said Peter Luo, Ph.D., Co-founder, Chief Executive Officer and Chairman of Adagene. "Our AI driven platforms have generated two highly differentiated CTLA-4 targeting molecules, ADG116 and ADG126. ADG116, our NEObody™ CTLA-4 candidate, is designed with strong antibody-dependent cellular cytotoxicity (ADCC) and softened T cell activation which combined, leading to increased potency with an improved safety profile. Our SAFEbody™ candidate ADG126 effectively limits on-target off-tumor toxicities in normal tissues and is designed for a superior systemic safety profile at efficacious dose levels with a significantly enhanced therapeutic window to overcome existing issues associated with current anti-CTLA-4 therapies."

    Dr. Luo continued, "Although we believe that ADG116 and ADG126 have great promise as single agents, combining with KEYTRUDA may unleash the potential of dual PD-1/CTLA-4 blockade, overcoming the safety profile limitations seen historically with this combination while also modulating different T cell populations to drive new immune functions and synergies not achievable through conventional monotherapies. Our extensive preclinical and early strong clinical data support this strategy, and we look forward to combining our anti-CTLA-4 therapeutics with anti-PD-1 checkpoint inhibitors such as KEYTRUDA to fulfill the potential of this combination therapy approach. We are fortunate to have the opportunity to explore this combination with Merck and tackle two of the most potent immunotherapy targets."

    "We are extremely pleased to partner with Merck to explore the therapeutic potential of ADG116 and ADG126 in combination with KEYTRUDA, as this collaboration represents an important milestone for Adagene, and for patients with advanced/metastatic solid tumors," said Steven Fischkoff, M.D., interim Chief Medical Officer of Adagene. "ADG116 program is at the 3 mg/kg dose level now which is where the commercial CTLA-4 therapy had been approved previously in mono and combination for specific indications. We expect to see differentiation going forward of our programs."

    KEYTRUDA® is a registered trademark of Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., Kenilworth, NJ, USA.

    About CTLA-4 Clinical Development Program

    ADG 116-P001: The Phase 1, open-label, dose escalation and cohort expansion study of ADG116 combined with KEYTRUDA in patients with advanced/metastatic solid tumors will be conducted at multiple sites in Asia and the United States. The study will evaluate the safety, tolerability, and recommended Phase 2 dose for ADG116 in combination with KEYTRUDA with dose escalation planned for up to 10 mg/kg. The study builds on encouraging signs of pharmacodynamic (PD) markers, favorable pharmacokinetic (PK) profile, strong early clinical data of the ADG116-1003 trial, extensive preclinical and safety tolerability data and successful Safety Review Committee meetings. In the ADG116-1003 trial, ADG116 has been well tolerated in 17 patients, with no dose-limiting toxicities or unexpected safety signals. No drug related Grade 2, Grade 3 or Grade 4 toxicities have been observed. Dosing for three additional patients has been completed in the 3 mg/kg cohort, for a total of 17 patients treated to date.

    ADG 126-P001: The Phase 1, open-label, dose escalation and cohort expansion study of ADG126 combined with KEYTRUDA in patients with advanced/metastatic solid tumors will be conducted at multiple sites in Asia and the United States. It will evaluate the safety, tolerability, and recommended Phase 2 dose for ADG126 in combination with KEYTRUDA with dose escalation planed for up to 10 mg/kg. The study builds on encouraging preclinical data, demonstrating ADG126 was well tolerated at doses up to 200 mg/kg, with 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. In the ADG126-1001 trial, dose limiting toxicity (DLT) evaluation has been completed in six patients in the 0.1 and 0.3 mg/kg cohorts.

    About Adagene

    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 therapeutic potential of ADG116 and/or ADG126 in combination with pembrolizumab to treat patients with advanced/metastatic solid tumors, data from the ADG116 and/or ADG126 clinical trials, clinical development plans of ADG116 and/or ADG126, 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 the potential failure of the combination of ADG116 and/or ADG126 and pembrolizumab to demonstrate safety and/or efficacy in the Phase 1 open-label, dose escalation and expansion studies; the clinical results for Adagene's 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 Tam

    Adagene

    86-512-8777-3626

    ir@adagene.com

    Bruce Mackle

    LifeSci Advisors

    646-889-1200

    bmackle@lifesciadvisors.com

    Media Contact:

    Tony Russo

    Russo Partners LLC

    212-845-4251

    tony.russo@russopartnersllc.com



    Primary Logo

    View Full Article Hide Full Article
  6. SAN FRANCISCO and SUZHOU, China, July 07, 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 that its board of directors has authorized a share repurchase program under which, Adagene may repurchase up to US$20 million of its ordinary shares in the form of American depositary shares, subject to the relevant rules under the Securities Exchange Act of 1934, as amended (the "Exchange Act"), and the Company's insider trading policy.

    "I am pleased to announce this share repurchase program, which is a strong indication of the Board's confidence in Adagene's globally…

    SAN FRANCISCO and SUZHOU, China, July 07, 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 that its board of directors has authorized a share repurchase program under which, Adagene may repurchase up to US$20 million of its ordinary shares in the form of American depositary shares, subject to the relevant rules under the Securities Exchange Act of 1934, as amended (the "Exchange Act"), and the Company's insider trading policy.

    "I am pleased to announce this share repurchase program, which is a strong indication of the Board's confidence in Adagene's globally differentiated pipeline driven by our proprietary NEObody, SAFEbody and POWERbody platforms," said Peter Luo, Ph.D., Co-founder, Chief Executive Officer and Chairman of Adagene. "We believe this program will ultimately benefit Adagene and create value for its shareholders and investors."

    The Company's share repurchases, if any, under the share repurchase program may be made from time to time on the open market at prevailing market prices, in open-market transactions, privately negotiated transactions or block trades, and/or through other legally permissible means, depending on market conditions and in accordance with the applicable rules and regulations. The timing and conditions of the share repurchases will be subject to various factors including the requirements under Rule 10b-18 and Rule 10b5-1 of the Exchange Act. The Company's board of directors will review the share repurchase program periodically and may authorize adjustments to its terms and size or suspend or discontinue the program. The Company expects to utilize its existing funds to fund repurchases made under this program.

    The share repurchase program is effective upon and from the date on which a formal stock repurchase plan engagement agreement is signed with a qualified broker-dealer(s), and terminates over a twelve-month period depending upon market and economic conditions, and other factors including price, legal and regulatory requirements and capital availability. The share repurchase program does not obligate Adagene to acquire any particular number of American depositary shares, and the share repurchase program may be modified or suspended at any time at the management's discretion.

    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. These statements are made under the "safe harbor" provisions of the U.S. Private Securities Litigation Reform Act of 1995. Statements that are not historical facts, including statements about the Company's beliefs and expectations, are forward-looking statements. Forward-looking statements involve inherent risks and uncertainties, and a number of factors could cause actual results to differ materially from those contained in any forward-looking statement. In some cases, forward-looking statements can be identified by words or phrases such as "may," "will," "expect," "anticipate," "target," "aim," "estimate," "intend," "plan," "believe," "potential," "continue," "is/are likely to" or other similar expressions. Further information regarding these and other risks, uncertainties or factors is included in the Company's filings with the SEC. All information provided in this press release is as of the date of this press release, and the Company does not undertake any duty to update such information, except as required under applicable law.

    Investors Contact:

    Raymond Tam

    Adagene

    86-512-8777-3626

    ir@adagene.com

    Bruce Mackle

    LifeSci Advisors

    646-889-1200

    bmackle@lifesciadvisors.com



    Primary Logo

    View Full Article Hide Full Article
  7. SAN FRANCISCO and SUZHOU, China, June 16, 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 that it will be added to the FTSE Global Equity Index Series ("GEIS"), including the FTSE Global Total Cap Index and FTSE Emerging Total Cap Index, effective June 21, 2021.

    "We believe that inclusion in the FTSE Russell indexes will meaningfully increase our visibility to the investment community and reflects the market's acceptance of Adagene Inc. as a publicly traded company," said Peter Luo, Ph.D., Co-founder, Chief Executive Officer and Chairman of Adagene. "Driven…

    SAN FRANCISCO and SUZHOU, China, June 16, 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 that it will be added to the FTSE Global Equity Index Series ("GEIS"), including the FTSE Global Total Cap Index and FTSE Emerging Total Cap Index, effective June 21, 2021.

    "We believe that inclusion in the FTSE Russell indexes will meaningfully increase our visibility to the investment community and reflects the market's acceptance of Adagene Inc. as a publicly traded company," said Peter Luo, Ph.D., Co-founder, Chief Executive Officer and Chairman of Adagene. "Driven by our proprietary NEObody, SAFEbody and POWERbody platforms, we look forward to continuing the design and development of novel antibodies that address unmet medical needs."

    FTSE Russell indexes are widely used by global institutional investors to benchmark their investment performance and create investment funds, ETFs, structured products and index-based derivatives.

    About FTSE Russell

    FTSE Russell is a leading global provider of benchmarks, analytics and data solutions with multi-asset capabilities, offering a precise view of the markets relevant to any investment process. FTSE Russell calculates thousands of indexes that measure and benchmark markets and asset classes in more than 70 countries, covering 98% of the investable market globally. For over 30 years, leading asset owners, asset managers, ETF providers and investment banks have chosen FTSE Russell indexes to benchmark their investment performance and create investment funds, ETFs, structured products and index-based derivatives. FTSE Russell is wholly owned by London Stock Exchange Group.

    About Adagene

    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. These statements are made under the "safe harbor" provisions of the U.S. Private Securities Litigation Reform Act of 1995. Statements that are not historical facts, including statements about the Company's beliefs and expectations, are forward-looking statements. Forward-looking statements involve inherent risks and uncertainties, and a number of factors could cause actual results to differ materially from those contained in any forward-looking statement. In some cases, forward-looking statements can be identified by words or phrases such as "may," "will," "expect," "anticipate," "target," "aim," "estimate," "intend," "plan," "believe," "potential," "continue," "is/are likely to" or other similar expressions. Further information regarding these and other risks, uncertainties or factors is included in the Company's filings with the SEC. All information provided in this press release is as of the date of this press release, and the Company does not undertake any duty to update such information, except as required under applicable law.

    Investors Contact:

    Raymond Tam

    Adagene

    86-512-8777-3626

    ir@adagene.com

    Bruce Mackle

    LifeSci Advisors

    646-889-1200

    bmackle@lifesciadvisors.com

    Media Contact:

    Annie Starr

    6 Degrees

    973-768-2170

    astarr@6degreespr.com



    Primary Logo

    View Full Article Hide Full Article
  8. SAN FRANCISCO, Calif. and SUZHOU, China, May 25, 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 that Adagene's Co-founder, Chief Executive Officer and Chairman, Peter Luo, Ph.D., will provide a corporate update and participate in one-on-one investor meetings at the Jefferies Virtual Healthcare Conference to be held June 1-4, 2021 and the Goldman Sachs 42nd Annual Global Healthcare Conference to be held June 8-11, 2021.

    Details on the presentations can be found below.

    Jefferies Virtual Healthcare Conference
    Date: Friday, June 4, 2021
    Presentation Time…

    SAN FRANCISCO, Calif. and SUZHOU, China, May 25, 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 that Adagene's Co-founder, Chief Executive Officer and Chairman, Peter Luo, Ph.D., will provide a corporate update and participate in one-on-one investor meetings at the Jefferies Virtual Healthcare Conference to be held June 1-4, 2021 and the Goldman Sachs 42nd Annual Global Healthcare Conference to be held June 8-11, 2021.

    Details on the presentations can be found below.

    Jefferies Virtual Healthcare Conference

    Date: Friday, June 4, 2021

    Presentation Time: 10:00 AM ET

    Webcast: Click Here

    Goldman Sachs 42nd Annual Global Healthcare Conference

    Date: Thursday, June 10, 2021

    Presentation Time: 5:30 PM ET

    Webcast: Click Here

    About Adagene

    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.

    Investors Contact:

    Raymond Tam

    Adagene

    86-512-8777-3626

    ir@adagene.com

    Bruce Mackle

    LifeSci Advisors

    646-889-1200

    bmackle@lifesciadvisors.com

    Media Contact:

    Annie Starr

    6 Degrees

    973-768-2170

    astarr@6degreespr.com



    Primary Logo

    View Full Article Hide Full Article
  9. -Identified a predictive biomarker and two pharmacodynamic biomarkers that correlate with clinical efficacy and target engagement

    -ADG106, a fully human, ligand-blocking, agonistic anti-CD137 antibody demonstrated a favorable safety profile

    SAN FRANCISCO and SUZHOU, China, May 19, 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 clinical data from its ADG106 NEObody™ program. Results from Phase I, open-label, dose-escalation, single center (NCT03802955) and multicenter (NCT03707093) studies of ADG106 in subjects with advanced or metastatic solid tumors…

    -Identified a predictive biomarker and two pharmacodynamic biomarkers that correlate with clinical efficacy and target engagement

    -ADG106, a fully human, ligand-blocking, agonistic anti-CD137 antibody demonstrated a favorable safety profile

    SAN FRANCISCO and SUZHOU, China, May 19, 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 clinical data from its ADG106 NEObody™ program. Results from Phase I, open-label, dose-escalation, single center (NCT03802955) and multicenter (NCT03707093) studies of ADG106 in subjects with advanced or metastatic solid tumors and/or relapsed/refractory non-Hodgkin lymphoma were presented in an abstract at the American Society of Clinical Oncology (ASCO) 2021 Annual Meeting. In these Phase I trials, ADG106 monotherapy exhibited a favorable safety profile and demonstrated promising clinical efficacy in biomarker positive patients. ADG106 is a fully human, ligand-blocking, agonistic anti-CD137 IgG4 antibody (mAb) engineered using Adagene's proprietary NEObody platform technology.

    "We are very pleased with the original finding of a predictive biomarker for our anti-CD137 agonist and its association with tumor shrinkage," said Peter Luo, Ph.D., Co-founder, Chief Executive Officer and Chairman of Adagene. "ADG106 has been well tolerated in dose escalation and extensive expansion cohorts at dosage of up to 5 mg/kg, which exceeds that of other anti-CD137 agonists. Further, this clinical data demonstrates the power of our proprietary NEObody platform designed to generate antibodies with novel mechanisms of action by targeting unique and highly conserved epitopes. We believe these results, together with analyses of PK and PD data from around 100 patient population, support the recommended dose regimen for ongoing clinical development of ADG106 as monotherapy and in combination with anti-PD-1 and other therapies. We look forward to multiple upcoming studies as we continue to advance our ADG106 clinical program."

    "Predictive biomarkers for patient stratification are critical to advances in precision immuno-oncology. It's compelling to identify a predictive biomarker for anti-CD137 agonism that shows a strong correlation between ADG106 treatment and tumor shrinkage," said Hua Gong, M.D. Ph.D., Chief Operating Officer and Head of Precision Medicine of Adagene. "In an upcoming global Phase Ib/II trial (ADG106-2001), we plan to enrich for populations expressing our predictive biomarker in order to demonstrate a clinical benefit to ADG106 therapy. Our predictive biomarker has the potential to optimize favorable treatment options and enable oncologists to preselect cancer patients who are likely to benefit from ADG106 treatment. In our continuing commitment to the development of precision immunotherapies, Adagene has established a center of excellence for precision medicine in San Diego with cutting-edge technologies to support biomarker-guided clinical trials."

    Interim data for the ongoing Phase 1 clinical trial includes:

    • Biomarker studies: In a retrospective analysis, 75% of biomarker positive patients demonstrated more than 30% tumor shrinkage after ADG106 treatment.



      • Tumor shrinkage was not significant among biomarker negative patients. There was a strong negative correlation (100%) between biomarker absence and clinical response.

      • A tissue microarray study confirmed biomarker expression in a variety of tumor types suggesting a broad indication for ADG106 therapy.
    • Target engagement: Target engagement upon ADG106 treatment was demonstrated with dose-dependent increases in NK cells in ADG106-mediated anti-tumor activities and in dose-dependent induction of soluble CD137 over baseline.



    • Safety and efficacy: ADG106 demonstrated a disease control rate of 56% and exhibited a favorable safety profile at 3mg/kg and 5mg/kg with dose escalation up to 10mg/kg.

    ADG106-1001 and ADG106-1002 Phase I trials have successfully completed enrollment of nearly 100 patients with advanced solid tumors and/or non-Hodgkin's lymphoma in the US and China, respectively. Limited TEAEs, i.e., liver toxicity or hematologic abnormalities, were observed. Following a productive end-of-phase I (EOP1) meeting about our ADG106 biomarker-stratified trial design with the FDA, Adagene made a new submission (ADG106-2001) to stratify patients using the predictive biomarker prior to treatment with ADG106 as monotherapy and its combination with anti-PD-1 therapy. In March 2021, Adagene initiated patient enrollment in China for ADG106-1008 (NCT04775680) a multicenter, open-label, Phase Ib/II study of ADG106 in combination with PD-1 antibody in advanced solid tumors and relapsed/refractory non-Hodgkin lymphoma. Preparations are underway for the ADG106-1003 trial in Australia to evaluate ADG106 in combination with other therapies in advanced solid tumors and hematological malignancies.

    About Adagene

    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.

    About ADG106

    ADG106, is a fully human ligand-blocking, agonistic anti-CD137 Immunoglobulin G4, or IgG4, mAb, being developed for the treatment of advanced solid tumors and non-Hodgkin's lymphoma, or NHL. CD137 stimulates the immune system to attack cancer cells and is a key driver for long-lasting T-cell proliferation and survival. In preclinical studies, we observed that ADG106 had robust antitumor activity and was well tolerated as a single agent and in combination with the existing standard-of-care and other immuno-oncology therapies. ADG106 activates CD137 in a native ligand-like fashion, blocks reverse signaling of CD137 ligand, and has potent cross-linking via Fc receptor. Because of this novel mechanism of action, ADG106 was observed to favorably balance CD137-induced toxicity and CD137 agonism, which we believe has potential to address the limitations of other existing anti-CD137 therapies.

    Safe Harbor Statement

    This press release contains forward-looking statements, including statements regarding data from the ADG106 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 ADG106. 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 Tam

    Adagene

    86-512-8777-3626

    ir@adagene.com

    Bruce Mackle

    LifeSci Advisors

    646-889-1200

    bmackle@lifesciadvisors.com

    Media Contact:

    Annie Starr

    6 Degrees

    973-768-2170

    astarr@6degreespr.com



    Primary Logo

    View Full Article Hide Full Article
  10. - 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…

    - 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 1H21
      • ADG106-1003 Phase 1b read-out from Australia trial in combination therapy in 2H21
      • ADG106-2001 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 2H21
      • Expand 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 2H21
      • Expand 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 Equivalents

    Our 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 Revenue

    Our 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 Loss

    Our 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 ended

    December 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 ended

    December 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 Tam

    Adagene

    86-512-8777-3626

    ir@adagene.com 

    Bruce Mackle

    LifeSci Advisors

    646-889-1200

    bmackle@lifesciadvisors.com 

    Media Contact:

    Annie Starr

    6 Degrees

    973-768-2170

    astarr@6degreespr.com 



    Primary Logo

    View Full Article Hide Full Article
  11. -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…

    -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 Adagene

    Adagene 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 Statement

    This 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 Contact

    Raymond Tam

    Adagene

    86-512-8777-3626

    ir@adagene.com

    Bruce Mackle

    LifeSci Advisors

    646-889-1200

    bmackle@lifesciadvisors.com

    Media Contact

    Annie Starr

    6 Degrees

    973-768-2170

    astarr@6degreespr.com



    Primary Logo

    View Full Article Hide Full Article
  12. SAN FRANCISCO and SUZHOU, China, March 16, 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 the first patients have been dosed in its global Phase 1 clinical trial of ADG126 for the treatment of various advanced solid tumors. ADG126 is a fully-human, antagonistic monoclonal antibody (mAb) targeting a novel epitope of CTLA-4 and is Adagene's lead SAFEbody™ product candidate.

    "Dosing the first patients in our Phase 1 clinical trial of ADG126 is an exciting milestone for the development of our SAFEbody technology platform," said Peter Luo, Ph.D., Co-founder…

    SAN FRANCISCO and SUZHOU, China, March 16, 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 the first patients have been dosed in its global Phase 1 clinical trial of ADG126 for the treatment of various advanced solid tumors. ADG126 is a fully-human, antagonistic monoclonal antibody (mAb) targeting a novel epitope of CTLA-4 and is Adagene's lead SAFEbody™ product candidate.

    "Dosing the first patients in our Phase 1 clinical trial of ADG126 is an exciting milestone for the development of our SAFEbody technology platform," said Peter Luo, Ph.D., Co-founder, Chief Executive Officer and Chairman of Adagene. "SAFEbody technology is designed to mask antibody binding sites, which will be activated specifically within the tumor microenvironment (TME), to provide favorable safety and efficacy with significantly enhanced therapeutic windows. Our most advanced SAFEbody candidate, ADG126 targets a conserved epitope of CTLA-4 with broad species cross-reactivity for potent Treg depletion via strong antibody-dependent cellular cytotoxicity (ADCC) in TME versus peripheral tissue. Our preclinical studies provide proof-of-concept for the potential of ADG126 in leveraging our SAFEbody platform to overcome standing issues associated with existing anti-CTLA-4 therapies by limiting on-target off-tumor toxicities in normal tissues."

    "Existing cancer therapies that target CTLA-4 are associated with safety concerns, creating an unmet need for new anti-CTLA-4 therapies that are both safe and potent," said Anthony W. Tolcher, M.D., FRCPC, FACP, medical oncologist, co-founder of NEXT Oncology ™, Adagene advisor and study investigator. "ADG126 demonstrated an impressive safety margin while maintaining its potent antitumor efficacy in pre-clinical studies, and I look forward to its evaluation in patients with 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. Adagene has also received approval from the FDA to initiate the Phase 1 clinical trial of ADG126 in the United States. The dose escalation trial will test five doses at 0.1, 0.3, 1.0, 3.0 and 10 mg/kg, with dose-limiting toxicities (DLT) evaluation for 3 weeks. Additional information about this clinical trial is available at ClinicalTrials.gov using the identifier: NCT04645069.

    About ADG126

    ADG126 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 in a four-week repeat-dose GLP toxicology study at doses up to 200 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 and in combination with anti-PD1 and other therapies.

    Unlike anti-PD1/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 Adagene

    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 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 Tam

    Adagene

    86-512-8777-3626

    ir@adagene.com

    Bruce Mackle

    LifeSci Advisors

    646-889-1200

    bmackle@lifesciadvisors.com

    Media Contact

    Annie Starr

    6 Degrees

    973-768-2170

    astarr@6degreespr.com



    Primary Logo

    View Full Article Hide Full Article
  13. SAN FRANCISCO, Feb. 11, 2021 (GLOBE NEWSWIRE) -- Adagene Inc. ("Adagene" or the "Company") (NASDAQ:ADAG), a platform-driven, clinical-stage biopharmaceutical company committed to transforming the discovery and development of novel antibody-based cancer immunotherapies, today announced the closing of its 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…

    SAN FRANCISCO, Feb. 11, 2021 (GLOBE NEWSWIRE) -- Adagene Inc. ("Adagene" or the "Company") (NASDAQ:ADAG), a platform-driven, clinical-stage biopharmaceutical company committed to transforming the discovery and development of novel antibody-based cancer immunotherapies, today announced the closing of its 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. Each ADS represents one and one quarter (1.25) ordinary shares of the Company. The ADSs began trading on the Nasdaq Global Market on February 9, 2021 under the ticker symbol "ADAG."

    Goldman Sachs (Asia) L.L.C., Morgan Stanley & Co. LLC and Jefferies LLC acted as the joint bookrunners of the offering. China Renaissance Securities (Hong Kong) Limited acted as co-manager of the offering.

    A registration statement related to these securities has been filed with, and declared effective by, the SEC. This press release shall not constitute an offer to sell or a solicitation of an offer to buy, nor shall there be any sale of these securities in any state or jurisdiction in which such an offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.

    This offering was made only by means of a prospectus forming part of the effective registration statement. A copy of the final prospectus relating to the offering may be obtained, when available, by contacting the following underwriters: (1) Goldman & Co L.L.C., Address: Prospectus Department, 200 West Street, New York, NY 10282-2198, by telephone at +1 (866) 471-2526 ; (2) Morgan Stanley & Co. LLC, Address: Prospectus Dept., 180 Varick Street, 2nd floor, New York, New York 10014, by telephone at +1 (866) 718-1649 and (3) Jefferies LLC, Address: Equity Syndicate Prospectus Department, 520 Madison Avenue, 2nd Floor, New York, NY 10022, by telephone at (877) 547-6340.

    About Adagene Inc. 

    Adagene 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. Its proprietary pipeline is comprised of 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. These statements are made under the "safe harbor" provisions of the U.S. Private Securities Litigation Reform Act of 1995. Statements that are not historical facts, including statements about the Company's beliefs and expectations, are forward-looking statements. Forward-looking statements involve inherent risks and uncertainties, and a number of factors could cause actual results to differ materially from those contained in any forward-looking statement. In some cases, forward-looking statements can be identified by words or phrases such as "may", "will," "expect," "anticipate," "target," "aim," "estimate," "intend," "plan," "believe," "potential," "continue," "is/are likely to" or other similar expressions. Further information regarding these and other risks, uncertainties or factors is included in the Company's filings with the SEC. All information provided in this press release is as of the date of this press release, and the Company does not undertake any duty to update such information, except as required under applicable law.

    For investor and media inquiries, please contact:

    Investors Contact:

    Raymond Tam

    Adagene

    86-512-8777-3626

    IR@adagene.com

    Media Contact:

    Annie Starr

    6 Degrees

    973-768-2170

    astarr@6degreespr.com



    Primary Logo

    View Full Article Hide Full Article
  14. SAN FRANCISCO, Calif., Feb. 09, 2021 (GLOBE NEWSWIRE) -- Adagene Inc. ("Adagene" or the "Company") (NASDAQ:ADAG), a platform-driven, clinical-stage biopharmaceutical company committed to transforming the discovery and development of novel antibody-based cancer immunotherapies, today announced that it has priced its initial public offering (the "IPO") of 7,354,000 American depositary shares ("ADSs"), at US$19.00 per ADS. The aggregate offering size of the IPO is approximately US$140.0 million, assuming the underwriters do not exercise their over-allotment option to purchase any additional ADSs. Each ADS represents one and one quarter (1.25) ordinary shares of the Company. The ADSs are expected to begin trading on the Nasdaq Global Market on…

    SAN FRANCISCO, Calif., Feb. 09, 2021 (GLOBE NEWSWIRE) -- Adagene Inc. ("Adagene" or the "Company") (NASDAQ:ADAG), a platform-driven, clinical-stage biopharmaceutical company committed to transforming the discovery and development of novel antibody-based cancer immunotherapies, today announced that it has priced its initial public offering (the "IPO") of 7,354,000 American depositary shares ("ADSs"), at US$19.00 per ADS. The aggregate offering size of the IPO is approximately US$140.0 million, assuming the underwriters do not exercise their over-allotment option to purchase any additional ADSs. Each ADS represents one and one quarter (1.25) ordinary shares of the Company. The ADSs are expected to begin trading on the Nasdaq Global Market on February 9, 2021 under the ticker symbol "ADAG." The IPO is expected to close on February 11, 2021, subject to customary closing conditions.

    The Company has granted the underwriters an option, exercisable for 30 days from the date of the final prospectus, to purchase up to an aggregate of 1,103,100 additional ADSs to cover over-allotments.

    Goldman Sachs (Asia) L.L.C., Morgan Stanley & Co. LLC and Jefferies LLC are acting as the joint bookrunners of the offering and representatives of the underwriters. China Renaissance Securities (Hong Kong) Limited is acting as co-manager of the offering.

    A registration statement related to these securities has been filed with, and declared effective by, the SEC. This press release shall not constitute an offer to sell or a solicitation of an offer to buy, nor shall there be any sale of these securities in any state or jurisdiction in which such an offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.

    This offering is being made only by means of a prospectus forming part of the effective registration statement. A copy of the final prospectus relating to the offering may be obtained, when available, by contacting the following underwriters: (1) Goldman & Co L.L.C., Address: Prospectus Department, 200 West Street, New York, NY 10282-2198, by telephone at +1 (866) 471-2526 ; (2) Morgan Stanley & Co. LLC, Address: Prospectus Dept., 180 Varick Street, 2nd floor, New York, New York 10014, by telephone at +1 (866) 718-1649 and (3) Jefferies LLC, Address: Equity Syndicate Prospectus Department, 520 Madison Avenue, 2nd Floor, New York, NY 10022, by telephone at (877) 547-6340.

    About Adagene Inc. 

    Adagene 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. Its proprietary pipeline is comprised of 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. These statements are made under the "safe harbor" provisions of the U.S. Private Securities Litigation Reform Act of 1995. Statements that are not historical facts, including statements about the Company's beliefs and expectations, are forward-looking statements. Forward-looking statements involve inherent risks and uncertainties, and a number of factors could cause actual results to differ materially from those contained in any forward-looking statement. In some cases, forward-looking statements can be identified by words or phrases such as "may", "will," "expect," "anticipate," "target," "aim," "estimate," "intend," "plan," "believe," "potential," "continue," "is/are likely to" or other similar expressions. Further information regarding these and other risks, uncertainties or factors is included in the Company's filings with the SEC. All information provided in this press release is as of the date of this press release, and the Company does not undertake any duty to update such information, except as required under applicable law.

    For investor and media inquiries, please contact:

    Investors Contact:

    Raymond Tam

    Adagene

    86-8777-3626

    Raymond_tam@adagene.com

    business@adagene.com

    Media Contact:

    Annie Starr

    6 Degrees

    973-768-2170

    astarr@6degreespr.com



    Primary Logo

    View Full Article Hide Full Article