Though conceptually understood for decades, antibody-drug conjugates (ADCs) haven’t begun to come into their own until recently, but oncology drug developers continue to wrestle with challenges, large among them the problem of antigen selection. Lately, companies including names such as Adagene Inc., Bioatla Inc. and Cytomx Therapeutics Inc., have taken particular interest in exploiting features of the cancer growth itself to add more oomph, with focus on special features of the tumor microenvironment (TME).

The basic idea for ADCs’ design took shape in the 1960s, but it wasn’t until 2011 that a product won approval from the FDA – one that stayed in place, anyway. In Augustof that year, Seattle Genetics Inc. won the go-ahead for Adcetris (brentuximab vedotin) for Hodgkin lymphoma systemic anaplastic large cell lymphoma. The label wasexpanded to include several other indications in 2017 and 2018.

ADC strivers breathed a sigh of relief with Adcetris’ regulatory success, given the problems with Mylotarg (gemtuzumab ozogamicin), a D33-directed product from Pfizer Inc. for acute myeloid leukemia (AML). Mylotarg trails a long history. First granted accelerated approval in May 2000 as a standalone treatment for older patients with CD33-positive AML who had experienced a relapse, Mylotarg was voluntarily withdrawn by Pfizer in 2010 after confirmatory research failed to verify clinical benefit and turned up safety concerns. The FDA’s September 2017 approval of Mylotarg called for a lower dose, a different schedule in combination with chemotherapy or on its own, and a new patient population. It’s labeled for newly diagnosed CD33-positive AML in adults and for pediatric patients ages 1 month and up, as well as for relapsed or refractory CD33 AML in adults and pediatrics 2 years and older.

ADCs have chalked whopper deals already this year. In early February, Mersana Therapeutics Inc. and Macrogenics Inc. separately signed contracts worth $1 billion-plus and $586 million, respectively. Mersana partnered with Johnson & Johnson’s Janssen Biotech, which forked over $40 million up front and pledged more than $1 billion in potential milestone payments. Macrogenics Inc. agreed to a tie-up with Amsterdam-based Synaffix BV to combine the former’s antibody and bispecific DART technology
with Synaffix’s linker-payload technology. Immunogen Inc. signed with Eli Lilly and Co. an ADC pact that could be worth $1.7 billion.

But ADC skepticism lingers among investors, as shown by Immunogen’s overall positive phase III news in ovarian cancer March 21, on which the stock (NASDAQ:IMGN) sunk more than 18%.

The past three years have seen seven ADC approvals in solid as well as hematological cancers. More are due, no doubt, as researchers figure out ways to leap the hurdles – among which a major one involves the aforementioned antigen selection, which Piper Sandler analysts dubbed “a rate-limiting step” in the space. Rolling out a 118-page report Feb. 15, they noted that “within solid tumors, antibody-based therapies [such as] ADCs have been limited to only a handful of tumor antigens (HER2, Nectin-4, TROP-2, etc.), as many potential targets do not provide a sufficient therapeutic window,” with toxicity arising because the ADC’s target antigen also manifests in healthy tissue. (This is what foiled Boehringer Ingelheim GmbH’s bivatuzumab mertansine, which targeted the CD44v6 antigen, and Bayer AG’s BAY-794620, which took aim at CA9.) “Improving the tumor selectivity of the targeting moiety and minimizing or eliminating binding in normal tissue is one area being explored that could greatly expand the utility of ADCs,” the report said.

‘Disruptive’ technology

Among the notable players zeroing in on the TME is Adagene, of San Diego and Suzhou, China, with an artificial intelligence discovery platform called the Dynamic Precision Antibody Library, powers with modalities that go by several names. Neobody is tooled to come up with antibodies that put unique epitopes in the crosshairs by new means. Powerbody and Safebody drugs are meant to exploit the TME. Along with partnerships, the firm has three wholly owned antibodies that have reached the phase Ib/II stage. ADG-126 is a Safebody targeting CTLA4. The other two fall under the Neobody aegis, taking aim at CTLA4 and CD37. Early this month, Adagene inked a research collaboration with Paris-based Sanofi SA, to find “masked” monoclonal and bispecific antibodies in a deal worth up to $2.5 billion plus royalties. Adagene will invent masked versions of Sanofi prospects, taking responsibility for early stage research activities using Safebody. Sanofi will do later-stage research and all clinical, product development and marketing activities.

Cytomx, of South San Francisco, uses its Probody technology to make Probody drug conjugates (PDCs), also a masking effort. The strategy adds a protease-cleavable linker peptide to the N-terminus of an antibody that can be cleaved by proteases overexpressed by tumor cells, which makes an inactivated prodrug while in circulation but one that turns on when in the TME. Two PDCs have reached clinical development. The lead program with CX-2009 targets CD166 and is undergoing phase II investigation for hormone receptor-positive breast cancer and triple-negative breast cancer. Cytomx’s other compound, CX-2029, has reached the dose-expansion stage in phase II trials testing the drug against squamous non-small-cell lung cancer (NSCLC), squamous cell carcinoma of the head and neck (HNSCC), esophageal/esophagogastric junction tumors and diffuse large B-cell lymphoma. Updates from both programs are expected this year.

San Diego-based Bioatla is advancing what it calls Conditionally Active Biologics (CABs) that take advantage of the differential pH of cancer cells. The firm has two firstin- class CAB ADCs in phase II development: BA-3011 (mecbotamab vedotin), which targets AXL and is being tested as a monotherapy and in combination with PD-1 drugs in soft-tissue and bone sarcoma, NSCLC and ovarian cancer; and BA-3021 (ozuriftamab vetodin), which targets ROR2 and is being tested as a monotherapy and in combination with PD-1 therapies in NSCLC, melanoma, HNSCC and ovarian cancer.

Especially high on Bioatla is H.C. Wainwright analyst Arthur He, who holds a “buy” rating on the stock with a $25 price target. “The platform is quite versatile, in that it could be used to generate any antibody-based biologic,” he wrote in a March 21 report. “Only about 11% of total cancer patients respond to checkpoint inhibitors, while systemic toxicities limit the therapeutic potential of CAR T therapies as well as ADCs,” he pointed out. The stock (NASDAQ:BCAB) has reached a 52-week high of $59.19 and a low of $4.22. CAB “has the potential to become a disruptive technology in antibody-based cancer therapy for solid tumors,” he said, estimating that Bioatla would generate risk-adjusted revenues of $534 million in 2031, growing from $6 million in 2024.

Findings continue to surface regarding the TME. Researchers at the University of Notre Dame recently published their discovery of a way tumor cells transfer geneticmaterial to other cells. They described in a March 1 article in Cell Reports how DNA “cargo” is moved around by way of extracellular microvesicles.

 

  • Presentations demonstrate compelling preclinical differentiation of an anti-CD47 antibody and a CD20xCD3 bispecific T-cell engager, both leveraging SAFEbody™ technology
  • Both candidates designed to overcome development challenges of two promising immuno-oncology targets

SAN DIEGO and SUZHOU, China, November 4, 2021 – 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 publication of two abstracts featuring preclinical data from its expanding pipeline in advance of the 63rd ASH Annual Meeting & Exposition.

The preclinical results show compelling differentiation of ADG153, an anti-CD47 SAFEbody and ADG152, a CD20xCD3 POWERbody™ integrating the company’s proprietary bispecific T-cell engager (TCE) platform with SAFEbody masking technology. The full abstracts are available on the ASH Annual Meeting and Exposition website in anticipation of poster presentations at the hybrid meeting being held virtually and in Atlanta, Georgia from December 11-14, 2021.

Details for the poster presentations during ASH 2021 include:

·  Title: ADG153, an Anti-CD47 Monoclonal Antibody Prodrug, Has Strong In Vivo Anti-Tumor Activity, Minimal RBC-Related and Antigen Sink Liabilities, and Extended Half Life in Comparison with Benchmark Clinical Antibodies of the Same IgG Subclass
Publication Number: 3342
Date: Monday, December 13, 2021
Poster Session III: 9:00 a.m. – 8:00 p.m. ET
Location & Time (for in-person participants): Hall B5 from 6:00 p.m. – 8:00 p.m. ET

·  Title: ADG152, a Novel CD20xCD3 T Cell Engager Prodrug with Enhanced Therapeutic Index, Demonstrates Strong Anti-Tumor Activity with Improved Safety
Publication Number: 1204
Date: Saturday, December 11, 2021
Poster Session I: 9:00 a.m. – 7:30 p.m. ET
Location & Time (for in-person participants): Hall B5 from 5:30 p.m. – 7:30 p.m. ET

“We are excited to share the first preclinical results from our ongoing evaluation of ADG152 and ADG153, which are two novel programs emerging from our deep, broad, and differentiated pipeline,” said Peter Luo, Ph.D., Co-founder, Chief Executive Officer and Chairman of Adagene. “The known challenges of targeting CD47 — specifically, the need for a Fc dependent efficacious antibody without triggering on-target off tumor liabilities, including binding to red blood cells or showing significant antigen sink in healthy cells — and those of bispecific CD3 TCEs — a clinically validated, powerful modality with cytokine release syndrome limiting their utility — are the ideal problems for our AI-powered platform and antibody engineering teams to overcome in a tailor-made manner.”

Dr. Luo continued, “We look forward to presenting more detailed results during the ASH sessions, including new data from our ADG153 program, with one of the first ever anti-CD47 antibodies of the IgG1 isotype on track for clinical development. Additionally, ADG152 is the first novel bispecific TCE that incorporates our SAFEbody anti-CD3 antibody which has a low binding affinity and demonstrates strong anti-tumor activity while maintaining an impressive control of cytokine release in vivo, an outstanding issue facing many TCEs in clinical development. We are extremely encouraged by the data supporting differentiation of these candidates, which collectively showcase how we are on the forefront of antibody discovery and development to address patient needs.”

The preclinical findings also reflect the advantages of the company’s AI-driven antibody discovery and development platform, which integrates the dynamic properties of antibody-based therapeutics into structure and design. Specifically, by targeting novel epitopes and introducing conditionally-activated masking technology, Adagene develops antibody candidates with tailor-made safety and efficacy profiles. When applied to powerful antibody-based modalities such as bispecific TCEs and antibody-drug conjugates, these therapeutic candidates are designed to reach beyond the therapeutic potency of traditional monospecific antibodies, while maintaining patient safety. These transformative technologies are known as NEObody™, SAFEbody™ and POWERbody™.

Both ADG152 and ADG153 are potential Investigational New Drug candidates from Adagene’s growing portfolio of preclinical discovery programs, five of which are in IND-enabling studies.

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.

Safe Harbor Statement

This press release contains forward-looking statements, including statements regarding ADG152 and ADG153 preclinical studies, the potential implications of preclinical findings of ADG152 and ADG153, and Adagene’s advancement of, and anticipated clinical development, regulatory milestones and commercialization of Adagene pipeline 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

  • Phase 1b/2 trial to be conducted at the National University Cancer Institute, Singapore and the National Cancer Centre Singapore, in Collaboration with the Singapore Translational Cancer Consortium
  • ADG106 now being evaluated in combinations with three leading anti-PD-1 therapies

SAN DIEGO, Suzhou, China, and SINGAPORE, October 27, 2021 – Adagene Inc. (“Adagene”) (Nasdaq: ADAG), the National University Cancer Institute, Singapore (NCIS) at the National University Hospital in Singapore, National Cancer Centre Singapore (NCCS), and the Singapore Translational Cancer Consortium (STCC), today announced the initiation of a phase 1b/2 clinical trial of the anti-CD137 agonist antibody, ADG106, in combination with the anti-PD-1 antibody, Nivolumab.

The trial will be led by Professor Goh Boon Cher, Senior Consultant, Department of Haematology-Oncology and Deputy Director (Research) at NCIS, and Associate Professor Daniel Tan, Head of the Division of Clinical Trials and Epidemiological Sciences and Senior Consultant, Division of Medical Oncology, NCCS. Both Professor Goh and Associate Professor Tan lead the STCC’s Cancer Clinical Trials & Investigational Medicine Unit that brings together centres in Singapore for scaled up capacity, efficiency and expertise in conducting cancer clinical trials.

ADG106 is being developed by Adagene for the treatment of advanced solid tumours and non-Hodgkin’s lymphoma. The phase 1b/2 trial will evaluate this novel combination in advanced non-small cell lung cancer (NSCLC) patients who have progressed on prior therapies.

Professor Goh commented, “NSCLC is the most prevalent type of lung cancer, which is the leading cause of cancer-related deaths worldwide. Despite recent progress, most patients will progress after receiving the newest generation of immunotherapy and immune checkpoint treatments. ADG106 has been shown to enhance the activity of T-cells based on pre-clinical data, including evidence of synergistic effect with anti-PD-1 agents in a refractory NSCLC tumour model. We look forward to evaluating the combination of ADG106 with Nivolumab and exploring the potential of this promising therapy in a patient population with unmet needs.”

“Pre-clinical studies evaluating the use of ADG106 with anti-PD-1 antibodies have shown promising results and we believe that this novel combination therapy can potentially address resistance to immune checkpoint inhibitors in metastatic NSCLC,” said Associate Professor Tan. “Through this study, we plan to utilise a series of cutting-edge translational approaches to understand mediators of response and resistance to checkpoint inhibitors.”

“We are excited to support this trial evaluating ADG106 in combination with Nivolumab, another leading anti-PD-1 therapy to be combined in clinical trials with ADG106 as a potential best-in-class treatment targeting CD137,” said Peter Luo, Ph.D., Co-founder, Chief Executive Officer and Chairman of Adagene.

“Building on the evidence of clinical efficacy demonstrated in our monotherapy trials, this trial will further explore the potential additive effect between ADG106 and anti-PD-1 agents. We are also delighted to partner with esteemed oncology research organisations that are leading cutting-edge care for patients in the region, as well as Bristol-Myers Squibb, a pioneer in research on anti-PD-1 therapy and anti-CD137 agonist antibodies.”

The phase 1b/2 open label trial is designed to evaluate safety, tolerability, and anti-tumour activity of the combination in up to 53 patients with advanced NSCLC who have progressed after prior treatment. The trial will also include exploratory biomarker analyses, including immune cell profiling in response to treatment.

The trial will involve work under the Lung Cancer programme that is supported by the RIE2020 Open Fund – Large Collaborative Grant (OF-LCG) programme, administered by the Singapore Ministry of Health’s National Medical Research Council (NMRC) and supported by the National Research Foundation Singapore, where Associate Professor Tan is the Corresponding Principal Investigator. OF-LCG is composed of a multi-disciplinary team of clinician-scientists, clinicians, researchers, molecular biologists and computational biologists across various research institutes in Singapore.

“This collaboration continues STCC’s goals to synergise cancer research capabilities across Singapore in a concerted approach, and promotes institutional-industry partnerships. We look forward to further collaborations with global biotech companies on innovations in screening, treatment and care for cancer patients,” said Professor Chng Wee Joo, Executive Director of STCC and Director of NCIS.

About Non-Small Cell Lung Cancer

There are two major types of lung cancers: small cell lung cancer and non-small cell lung cancer (NSCLC). About 85 percent to 90 percent of lung cancers are non-small cell lung cancers. The major differences between these two types of lung cancers are the size and shape of the cancer cell, forms of treatment and the speed at which the cancer spreads.

NSCLC is the leading cause of cancer-related deaths worldwide, accounting for approximately 18 per cent of all cancer deaths. Despite the proven use of low-dose CT scan as a screening tool for lung cancer, most patients still present with stage 3 or 4 disease and only about 20 percent are operable, with a five-year survival overall of about 10 percent[1]. Metastatic disease is the primary cause of death from NSCLC.

Until recently, chemotherapy has been the only available therapy for metastatic disease. However, much effort has been made to understand the molecular underpinning of NSCLC, and in non-squamous NSCLC, molecular drivers have been uncovered to direct the specific treatment of this subgroup of patients.

About ADG106

ADG106, is a fully human ligand-blocking, agonistic anti-CD137 IgG4 mAb being developed for the treatment of advanced solid tumours 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. Clinical trials of ADG106 as monotherapy have been conducted in the U.S. and China. A trial in combination with toripalimab is underway in China, and one in combination with pembrolizumab is planned in the U.S. and Asia Pacific (APAC).

About Nivolumab

Nivolumab, marketed globally as Opdivo, is a programmed death-1 (PD-1) immune checkpoint inhibitor that is designed to uniquely harness the body’s own immune system to help restore anti-tumour immune response. By harnessing the body’s own immune system to fight cancer, Nivolumab has become an important treatment option across multiple cancers, including advanced NSCLC.

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 programmes. 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 National University Cancer Institute, Singapore (NCIS)

NCIS offers a broad spectrum of cancer care and management covering both paediatric and adult cancers, with expertise in prevention, screening, diagnosis, treatment, rehabilitation and palliative care. The Institute’s strength lies in the multi-disciplinary approach taken to develop a comprehensive and personalised plan for each cancer patient and his or her family. Our award-winning clinician-scientists and clinician-investigators conduct translational research and clinical trials, providing patients with access to evidence-based cancer diagnostics, technology and therapies.

For more information about NCIS, please visit http://www.ncis.com.sg.

About Singapore Translational Cancer Consortium

STCC aims to strengthen the overall impact of cancer research and translation in Singapore by bringing together key basic, clinical and translational teams on joint platforms to actively establish and implement collaborative cancer programmes. STCC strives to establish Singapore as a global leader for oncology in research translation and its applications to health and economic value creation.

STCC is a business unit under the Consortium for Clinical Research and Innovation, Singapore (CRIS), a subsidiary of Ministry of Health Holdings (MOHH), and is anchored by the cancer research programmes and commercialisation platforms of STCC’s research partners (NCCS, NCIS, National University of Singapore [NUS] Cancer Science Institute [CSI] and Agency for Science, Technology and Research [A*STAR]).

STCC is supported with funding from the National Research Foundation, Singapore and administered by the Singapore Ministry of Health.

For more information, please visit www.stcc.sg.

About the National Cancer Centre Singapore

The National Cancer Centre Singapore (NCCS) is a leading national and regional tertiary cancer centre with specialists who are experts in treating cancer. NCCS attends to the majority of cancer cases in Singapore’s public healthcare sector. In addition to offering holistic and multidisciplinary oncology care, our clinicians and scientists collaborate with local and international partners to conduct robust, cutting-edge clinical and translational research. To achieve the vision of being a global leading cancer centre, NCCS offers world class care and shares its depth of experience and expertise by training local and overseas medical professionals.

To meet growing needs, the new NCCS building will be completed in 2022 with increased capacity and expanded facilities dedicated to cancer care, rehabilitation, research and education. To give patients the best treatment outcomes, NCCS will offer access to advanced and innovative treatment such as proton therapy at the new Goh Cheng Liang Proton Therapy Centre.

For more information, please visit: www.nccs.com.sg.

Safe Harbor Statement

This press release contains forward-looking statements, including statements regarding the potential impact of combination trial of ADG106 and nivolumab, potential implications of clinical data for patients, clinical development programs and related clinical trial data, the potential benefits, safety and efficacy of our collaboration partners’ products and investigational therapies, 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.

Media Contact:

Bruce Mackle
LifeSci Advisors
646-889-1200
bmackle@lifesciadvisors.com

Adagene Investor Contact:

Ami Knoefler
Adagene
650-739-9952
ir@adagene.com

SAN FRANCISCO and SUZHOU, China, October 21, 2021 – 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 China Biotech Summit to be held October 26, 2021.

Details on the presentation include:

Date: Tuesday, October 26, 2021
Presentation Time: 3:00 p.m. Eastern

A live webcast of the presentation will also 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

SAN FRANCISCO, Calif. and SUZHOU, China, September 2, 2021 – 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

  • 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, Calif. and SUZHOU, China, August 26, 2021 – 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)
  • Collaboration to evaluate NEObody™ product candidate, ADG106, in combination with KEYTRUDA® for patients with advanced or metastatic solid and/or hematological malignancies

SAN FRANCISCO, Calif., August 19, 2021 – 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-PD-1 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

  • Global immuno-oncology experts bring decades of experience to advance company’s transformative research and development pipeline

SAN FRANCISCO, Calif. and SUZHOU, China, August 12, 2021 – 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® (ipilumumab), 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

  • Two global clinical studies to evaluate NEObody™ product candidate, ADG116, and SAFEbody™ product candidate, ADG126, in combination with KEYTRUDA® (pembrolizumab) for patients with advanced/metastatic solid tumors

SAN FRANCISCO, Calif., July 22, 2021 – 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.

For more information, please visit: https://investor.adagene.com.

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

SAN FRANCISCO, Calif. and SUZHOU, China, July 7, 2021 – 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

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