-three clinical collaborations were reached with Merck & Co Inc to advance the global joint trial of three clinical anti-tumor candidates and pablizumab-

-ADG106 monotherapy clinical trials show good efficacy and safety, and focus on promoting the indication of high expression of biomarkers and the combined treatment of patients with PD-1 resistance.

-the ongoing phase I trial shows that the new anti-CTLA-4 new epitope antibody (NEObodyTM) ADG116 has a highly differentiated clinical product characterization.

-the first safety antibody project, ADG126 Phase I, clinical dose climbing is progressing smoothly.

-A powerful technical platform aimed at the development of original antibodies continues to promote a number of preclinical projects into the clinical declaration process-

-the further expanded management team works closely with the global clinical and strategic consulting team to empower the company's transformative clinical pipeline development-

Suzhou, China and San Francisco, USA Aug. 26 / PRNewswire-Asianet /-- Adagene Inc (NASDAQ: ADAG) is a platform-driven clinical-phase biopharmaceutical company dedicated to the discovery and development of novel cancer immunotherapies based on original antibodies. The company today announced its financial results and latest business progress for the six months ended June 30, 2021.

With Tien Yan's unique computational biology and antibody technology discovery platform driven by artificial intelligence (AI), we have built an innovative product pipeline focusing on tumor immunotherapy. Through novel agonistic antibodies targeting CD137 and innovative therapeutic combinations of anti-CTLA-4 antibodies under new mechanisms, we hope to further unleash the potential of tumor immunity as an important pillar of modern cancer therapy. In the first half of 2021, we continue to promote the development of three highly differentiated clinical candidates, "said Dr. Luo Peizhi, co-founder, CEO and chairman of Tianxiu." through the three cooperation with Merck & Co Inc, we have further improved the global clinical development strategy and optimized the trial program to improve operational efficiency. We look forward to the follow-up of key clinical data. With proprietary technology platforms and translational medical experience, Tianxiang addresses the core challenge of oncology drug development by balancing safety and effectiveness. "

In the near futureBusiness is bright点And expectationMilestone event

ADG106：An all-human ligand blocking anti-CD137 agonistic IgG4 monoclonal antibody (mAb) was generated by NEObody epitope antibody technique. Patients with advanced solid tumors and / or non-Hodgkin's lymphoma are currently being evaluated.

• 98 patients were evaluated in phase I monotherapy dose increment trials in the United States (ADG106-1001) and China (ADG106-1002).
  • ADG106 showed good tolerance in the dose expansion of 3 mg/kg and 5 mg/kg. Only limited adverse reactions (TEAEs) (i.e. limited hepatotoxicity or hematological abnormalities) were observed. The results showed that the disease control rate of ADG106 monotherapy was 56%, more than 30% of tumor shrinking was observed in 75% of biomarker positive patients (through retrospective analysis), and partial remission was observed in a solid tumor patient who had previously failed treatment assessed by RECIST v1.1.
  • The above figures were announced at the ASCO 2021 meeting.
• Phase Ib/II clinical trial (ADG106-1008) is in the process of dose climbing to evaluate the safety and preliminary efficacy of ADG106 in combination with the approved anti-PD-1 drug triprizumab (toripalimab) in China. This trial is aimed at tumor patients who have previously failed in standard therapy and / or immune tumor therapy and whose biomarkers are positive.
  • Preliminary data show that the target binding shown by dose-dependent pharmacodynamic biomarkers is consistent with that of monotherapy trials.
  • Phase Ib/II clinical trials of ADG106 combined with pembrolizumab (ADG106- P2001; KEYNOTE-D12) in the United States and Asia Pacific, by integrating early plans for the ADG106- 2001 trial, will focus on indications for high expression of biomarkers. Data for the trial are expected to be released in 2022.
• Recent ADG106 milestones:
  • The second half of 2021
    • Results of ongoing trials of combined triplet monoclonal antibody (ADG106-1008)
    • Patients in monotherapy trials in the United States (ADG106-1001) and China (ADG106-1002) completed follow-up
  • 2022
    • Results of combined test with pablizumab (ADG106-P2001)

ADG116：The unique epitope that targets CTLA-4 generated by the NEObody epitope antibody technique is currently being evaluated in patients with advanced / metastatic solid tumors. ADG116 aims to improve the efficacy by removing regulatory T cells (Treg) from tumor microenvironment (TME) and maintain its physiological function by blocking flexible ligands, which is expected to overcome the safety problems of existing anti-CTLA-4 therapy.

• The Global Phase I clinical trial (ADG116-1003) is in dose climbing to assess the safety and tolerance of ADG116 in patients with advanced / metastatic solid tumors:
• ADG116 did not show dose-limiting toxicity (DLT) in the high dose group of 6 mg/kg, which was twice as high as the approved dose level of 3 mg/kg in multiple indications of CTLA-4 therapy. Patients in the 10 mg/kg dose group began to enter the group.
  • The trial is expected to expand the cohort this year: to evaluate the safety and preliminary efficacy of ADG116 and tripril or ADG106 in patients with advanced / metastatic solid tumors through two joint cohorts, while integrating early plans for the ADG106-1003 trial.
• It has been approved by the State Drug Administration (NMPA) for new drug clinical trials (IND) for single-drug treatment trials in China (ADG116-1002).
• The Phase I trial of ADG116 combined with Paprizumab (ADG116-P001) is expected to be launched and promoted in the United States and the Asia-Pacific region in 2022.KEYNOTE-C97）。
• Recent ADG116 milestones:
  • The second half of 2021
    • Results of continuous dose increase in ADG-116 monotherapy (ADG116-1003)
  • 2022
    • Results of dose increment in joint cohorts, including the combination of ADG116 with tripril and ADG106 (ADG116-1003)
    • Results of combined test with pablizumab (ADG116-P001)

ADG126：Generated by SAFEbody antibody technology, it targets the unique epitope of CTLA-4, which performs well in preclinical studies and aims to provide higher safety. ADG126 is activated only in tumor microenvironment (TME). It enhances the efficacy by effectively eliminating regulatory T cells (Treg) and maintains its physiological function by blocking flexible ligands, which significantly improves the treatment window and is expected to solve the safety problems of existing CTLA-4 therapy.

• The Global Phase I Clinical trial (ADG126-1001) is in dose climbing to evaluate the safety and tolerance of ADG126 in patients with advanced / metastatic solid tumors.
• In April 2021, Tianyuan announced the latest preclinical data of AACR at the annual meeting of ADG126. The data show that ADG126, as a monotherapy and in combination with anti-PD-1 and other therapies, is still well tolerated at doses up to 200 mg/kg, and shows excellent anti-tumor efficacy in a variety of immune-sound mouse tumor models.
• Applications for phase I, incremental dose and extended cohort clinical trials (ADG126-1002) of ADG126 as a monotherapy and in combination with approved anti-PD-1 triplizumab were submitted to NMPA to evaluate safety and preliminary efficacy in patients with advanced / metastatic solid tumors.
• The Phase I trial of ADG126 combined with Paporizumab (ADG126-P001;KEYNOTE-C98) is expected to be launched in the United States and the Asia-Pacific region in 2022.
• Recent ADG126 milestones:
  • The second half of 2021
    • The result of increasing dose of ADG126 monotherapy (ADG126-1001)
  • 2022
    • Results of dose increment and queue expansion of ADG126 (ADG126-1002)
    • Results of combined test with pablizumab (ADG126-P001)

Preclinical R & D projects:Continue to expand and advance innovative preclinical pipelines to achieve the goal of submitting more than 10 IND or other similar applications over the next three to five years with new epitope antibody NEObody antibodies, safe antibody SAFEbody bands and / or strong antibody POWERbody bands technologies.

Currently, five programs generated by POWERbody and SAFEbody technologies are in the preclinical study (IND) phase of new drug applications, including a highly differentiated anti-CD47 program and bispecific T-cell binding antibodies (Bispecific T cell engager) for blood and solid tumors.

• All five projects have good proprietary properties (CMC nature) and have encouraging preclinical safety and efficacy data.
• Since March 31, 2021, the company has advanced two other projects to the CMC phase, further strengthening the candidate product portfolio for future IND.
• Recent milestones in preclinical products:
  • 2021
    • Continue to promote multiple product candidates in the preclinical study (IND) phase of new drug applications
  • 2022
    • Submit multiple IND or other similar applications and promote the development of new product candidates from the company's highly differentiated transformational preclinical pipeline

Commercial cooperation project

• Established a clinical trial cooperation and drug supply agreement with Merck & Co Inc on three clinical candidate products:
  • In July 2021, Tianyan partnered with Merck & Co Inc, a leader in the field of immune oncology, in two clinical trials. The combination of Adagene Inc's anti-CTLA-4 monoclonal antibody (mAb) candidate products ADG116 and ADG126 with Merck & Co Inc's anti-PD-1 drug KEYTRUDA ®(Pablizumab) will initiate clinical trials of two open-label, dose increment and expansion studies to evaluate the clinical efficacy of the combination in patients with advanced / metastatic solid tumors.
  • In August 2021, Tianyan partnered with Merck & Co Inc to conduct a third clinical trial to evaluate the clinical efficacy of a combination of anti-CD137 agonistic monoclonal antibody ADG106 and pabrizumab in patients with advanced or metastatic solid and / or hematological malignant tumors.
• Cooperate with Guilin Sanjin Pharmaceutical Co., Ltd. (hereinafter referred to as Sanjin) and its subsidiaries to develop two monoclonal antibodies with different targets:
  • ADG104 is a monoclonal antibody targeting PD-L1, and positive clinical data have been observed in phase Ib and phase II clinical trials conducted simultaneously in China. As of June 30, 2021, 4 patients were in partial remission and 16 were in stable condition. Of the 40 assessable cancer patients who received ADG104 monotherapy, the disease control rate was 50%.
  • The second product jointly developed by the two sides is a monoclonal antibody targeting CSF-1R, which was approved by NMPA IND in March 2021 and is expected to join the first patient in the group soon.

The latest developments in the company

• The company announces that the following changes will be made to the composition of the board of directors, effective on the same day. Mr. Miao Yu, a director designated by JSR Limited under the current shareholders' agreement, has resigned from the board of directors for personal reasons. Mr. Miao Yu confirmed that there was no disagreement with the company. The company thanks Mr. Miao Yu for his diligent work and valuable contribution to the board of directors during his tenure.
• Further expand the leadership team:
  • Steven Fischkoff, M.D., was appointed acting Chief Medical Officer. As a certified medical oncologist, Dr. Fischkoff has been in the pharmaceutical industry for 30 years. Previously, while working at Medarex, Dr. Fischkoff was responsible for the clinical development of Yervoy ®(Epimazumab). Epimazumab is the first immune checkpoint inhibitor and is so far the only anti-FDA approved product. During his tenure with Knoll Pharmaceuticals and Abbott Laboratories in the United States, Dr. Fischkoff successfully led the world's best-selling drug Humira ®(Adamumab) from phase I clinical trials to the final submission of marketing applications, which were approved in the United States and the European Union.
  • Dr. Shang Jin was appointed Senior Vice President of Global Registration and Regulatory Affairs. Dr. Shang has more than 20 years of drug development and regulatory experience in the biopharmaceutical industry. Prior to joining Tianxiang, he was the Director of Regulatory Affairs of AstraZeneca PLC's Oncology Department, and earlier he held positions at Sun Pharma, Morphic Therapeutics and Merck & Co Inc, respectively.
  • Dr. Zeng Wenlin was appointed as a cell line.及上Swim awayVice president of hair. Dr. Zeng will be responsible for cell line construction and upstream production process development, and will supervise the follow-up production of biological agents. Dr. Zeng has more than 20 years of experience in cell line development, cGMP cell bank construction and API manufacturing. Prior to joining the show, she served as a senior director of Gilead and earlier worked at Forty-Seven, NGM Bio, Advanced Bioscience Laboratories, GlaxoSmithKline PLC, MedImmune Vaccines, Abgenix and Scios.
  • Ami C. Knoefler was appointed Vice President of Investor Relations and Corporate Communications. She has more than 25 years of experience in the field of communication in multinational pharmaceutical companies, bio-pharmaceutical companies and the medical industry. Before joining the show, she served as a senior director of Ascendis Pharma, and earlier worked at Jazz Pharmaceuticals, PDL BioPharma, Abgenix and Bristol-Myers Squibb.
• The company has appointed new members of the Science and Strategy Advisory Board: Steven Fischkoff, Stanley Frankel, FACP, and Robert Spiegel, FACP. The Science and Strategy Advisory Board is composed of a number of scientists and clinical experts who have made important contributions in the field of tumor immunity, who will work closely with the Tiantian management team and other clinical researchers to provide strategic support for the global development of the company's revolutionary R & D pipeline.
• In July, the company's board of directors approved a share buyback program that authorizes Tiantian to buy back American depositary shares with a total value of up to $20 million in the form of American depositary shares (ADS).

2021Financial highlights in the first half of the year

Cash and cash equivalents

As at 30 June 2021, cash and cash equivalents were $208.3 million, compared with $75.15 million as at 31 December 2020. The increase in cash and cash equivalents was mainly due to the net capital raised by the company's initial public offering of $145.9 million in February 2021. In addition, the company received a down payment of $11 million from Exelixis in March 2021 under the terms of the cooperation and license agreement.

Advances and other current assets

As at 30 June 2021, advances and other current assets were $5.39 million, compared with $3.81 million as at 31 December 2020. This growth is driven by the expansion of R & D business and the increase in related advances.

Contractual liability

Contract liabilities as at 30 June 2021 were $11.1 million, compared with $730000 as at 31 December 2020. The increase in contract liabilities is due to the fact that the down payment of $11 million received from Exelixis in March 2021 has not yet met the relevant performance obligations for revenue recognition.

Net income

Net income for the six months ended June 30, 2021 was $1.36 million, compared with $310000 for the same period in 2020. The main source of net income growth is that the company received US $1.2 million from Baoshan Biopharmaceutical Technology ("Baoshan"), a subsidiary of Guilin Sanjin. The recognition of the revenue is based on the fact that the company has fully fulfilled its obligations related to the development of antibody therapy in cooperation with Baoshan.

Research and development（R & D）Expenses

Research and development costs for the six months ended June 30, 2021 were $31.46 million, compared with $14.91 million for the same period in 2020. The increase in R & D costs is mainly due to: (I) an increase of $4.3 million in salary and other related labor costs due to the increase in the number and average salary level of R & D personnel; (ii) an increase of $3.1 million in equity incentive expenses related to R & D personnel; and (iii) an increase of $8 million in preclinical testing and clinical trial related costs due to increased project progress and contract manufacturing costs. In the six months ended June 30, 2021, Tianxiang paid a total of $16.6 million for ADG106, ADG116 and ADG126 projects, compared with $13 million in the same period in 2020. In addition, the company incurred a total of $14.8 million in preclinical drug candidates, R & D pipelines and other projects in the six months ended June 30, 2021, compared with $1.9 million in the same period in 2020.

Management (GambiA）Expenses

Administrative expenses for the six months ended 30 June 2021 were $7.4 million, compared with $4.73 million for the same period in 2020. The increase is due mainly to: (I) increases in the number and average remuneration level of administrative staff; and (ii) increases in professional and office costs.

Net loss

The net loss attributable to Adagene Inc shareholders for the six months ended June 30, 2021 was $37.19 million, compared with $18.19 million for the six months ended June 30, 2020.

非American general accountingGuidelines (Non-GAAPNet loss under)

Net loss under non-GAAP is defined as net loss under GAAP for the period excluding: (I) equity incentive fees; and (ii) convertible redeemable preferred shares are increased to redeemable value. Net loss under non-Non-GAAP accumulated $27.04 million for the six months ended June 30, 2021, compared with $11.09 million for the same period in 2020. Please refer to the section entitled "performance reconciliations under GAAP and non-Non-GAAP" in this press release for details.

Measurement of non-American General Accounting Standards (Non-GAAP) financial indicators

Adagene Inc uses Non-GAAP 's net loss and Non-GAAP 's net loss per common share to evaluate the Company's operating results, as well as financial and operating decisions. The Company believes that the net loss of Non-GAAP and the net loss per common share of Non-GAAP help to identify fundamental trends in the Company's business, which may be distorted by the impact of certain charges recorded by the Company in losses for the current year / period. The Company believes that Non-GAAP 's net loss and Non-GAAP 's net loss per common share provide useful information about its operating results, improve overall understanding of its past performance and future prospects, and make key indicators used by management in financial and operational decisions more visible.

For the measurement of Non-GAAP financial indicators for the current year / period, the net loss of Non-GAAP used by Adagene Inc and the net loss per common share of Non-GAAP shall not be considered separately, nor shall they be regarded as a substitute for operating profit, net loss or any other performance measure for that year / period, or as a measure of its operating performance. Investors are encouraged to review the net loss of Non-GAAP and the net loss per common share of Non-GAAP for the year / period, as well as the adjustment process of financial indicators under the most directly comparable GAAP. The net loss of Non-GAAP and the net loss per common share of Non-GAAP for the year / period listed here may not be compared with the financial indicators of similar names provided by other companies. Other companies may calculate similar financial indicators in different ways, limiting their usefulness as comparable data for companies. Adagene Inc encourages investors and others to review the company's financial information comprehensively, rather than focusing on a single financial indicator.

The net loss of Non-GAAP and Non-GAAP 's net loss per common share under the net profit indicator calculated for the current year / period excludes equity incentive fees and convertible redeemable preferred shares are increased to redeemable value. Equity incentive expenses are non-cash expenses generated by granting stock incentives to employees. We believe that the adjustment information of GAAP and non-GAAP can be helpful to management and investors in comparing the company's operating performance and peer-to-peer comparison. The reasons are: (I) equity incentive fees during a particular period may not be directly related to the company's operating performance; (ii) equity incentive fees may vary significantly in different periods due to the timing of the company's granting of new equity incentive plans; and (iii) other companies may adopt different forms of equity incentives or use different valuation methods.

Please refer to the "statement of performance adjustments under GAAP and non-Non-GAAP" at the end of this announcement to obtain the complete adjustment process of the net loss of Non-GAAP and Non-GAAP 's net loss per common share for the current year / period.

About Adagene Inc

Adagene Inc (NASDAQ: ADAG) is a platform-driven biopharmaceutical company with the clinical product development phase of its own platform. The company is committed to the discovery and development of new cancer immunotherapies based on original antibodies. With the help of computational biology and artificial intelligence, and with its world's first three-body platform technology (new epitope antibody NEObody antibody, safe antibody SAFEbody antibody and strong antibody POWERbody antibody), Adagene Inc has established a unique original antibody product line focusing on new tumor immunotherapy to address unmet clinical needs. Tianyan has reached a strategic partnership with a number of global well-known partners and empowered new drug research and development with its original cutting-edge science and technology as partners.

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

Safe harbor declaration

This press release contains forward-looking statements, including statements about the potential impact of clinical data on patients, as well as Adagene Inc's advance and expected preclinical activities, clinical development, regulatory milestones and the commercialization of his candidate products. Due to a variety of important factors, including, but not limited to, Adagene Inc's ability to demonstrate the safety and effectiveness of his drug candidates, the actual results may differ materially from those shown in the forward-looking statements; the clinical results of his drug candidates may not support further development or regulatory approval; the content and timing of the regulatory approval of Adagene Inc's drug candidates by the relevant regulatory authorities If approved, Adagene Inc's ability to achieve commercial success as his drug candidate; Adagene Inc's ability to obtain and maintain intellectual property protection for his technology and drugs; Adagene Inc's reliance on third parties for drug development, manufacturing and other services; Adagene Inc's limited business history and Adagene Inc's ability to obtain additional working capital and complete the development and commercialization of his drug candidates Adagene Inc's ability to sign additional cooperation agreements in addition to his existing strategic partnership or cooperation, and the impact of the COVID-19 epidemic on Adagene Inc's clinical development, business and other operations, as well as those risks that are more fully discussed in the "risk factors" section of the SEC filings. All forward-looking statements are based on information currently available to Adagene Inc, and Adagene Inc assumes no obligation to publicly update or revise any forward-looking statements as a result of new information, future events or other reasons, unless required by law.

Company contact:
Wu Ying
Adagene Inc
0512-8777-3632 转 8660
Ir@adagene.com

Investor contact:
Bruce Mackle
LifeSci Advisors
(01)646-889-1200
Bmackle@lifesciadvisors.com

Related links:

Https://investor.adagene.com