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Adagene Reports Financial Results for the Six Months Ended June 30, 2021 and Provides Corporate Updates

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

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

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

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

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

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

SAN FRANCISCO and SUZHOU, China, Aug. 26, 2021 (GLOBE NEWSWIRE) — Adagene Inc. (“Adagene”) (Nasdaq: ADAG), a platform-driven, clinical-stage biopharmaceutical company committed to transforming the discovery and development of novel antibody-based immunotherapies, today reported financial results for the six months ended June 30, 2021, and provided corporate updates.

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

Recent Highlights and Upcoming Milestones  

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

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

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

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

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

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

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

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

Collaborations:

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

Corporate Updates

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

Financial Highlights

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

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

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

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

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

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

Net Loss
The net loss attributable to Adagene Inc.’s shareholders was US$37.2 million for the six months ended June 30, 2021, compared to US$18.2 million for the six months ended June 30, 2020.

Non-GAAP Net Loss
Non-GAAP net loss, which is defined as net loss attributable to ordinary shareholders for the period after excluding (i) share-based compensation expenses and (ii) accretion of convertible redeemable preferred shares to redemption value was US$27.0 million for the six months ended June 30, 2021, compared to US$11.1 million for the six months ended June 30, 2020. Please refer to the section in this press release titled “Reconciliation of GAAP and Non-GAAP Results” for details.

Non-GAAP Financial Measures

The Company uses non-GAAP net loss and non-GAAP net loss per ordinary shares for the year/period, which are non-GAAP financial measures, in evaluating its operating results and for financial and operational decision-making purposes. The Company believes that non-GAAP net loss and non-GAAP net loss per ordinary shares for the year/period help identify underlying trends in the Company’s business that could otherwise be distorted by the effect of certain expenses that the Company includes in its loss for the year/period. The Company believes that non-GAAP net loss and non-GAAP net loss per ordinary shares for the year/period provide useful information about its results of operations, enhances the overall understanding of its past performance and future prospects and allows for greater visibility with respect to key metrics used by its management in its financial and operational decision-making.

Non-GAAP net loss and non-GAAP net loss per ordinary shares for the year/period should not be considered in isolation or construed as an alternative to operating profit, loss for the year/period or any other measure of performance or as an indicator of its operating performance. Investors are encouraged to review non-GAAP net loss and non-GAAP net loss per ordinary shares for the year/period and the reconciliation to their most directly comparable GAAP measures. Non-GAAP net loss and non-GAAP net loss per ordinary shares for the year/period here may not be comparable to similarly titled measures presented by other companies. Other companies may calculate similarly titled measures differently, limiting their usefulness as comparative measures to the Company’s data. The Company encourages investors and others to review its financial information in its entirety and not rely on a single financial measure.

Non-GAAP net loss and non-GAAP net loss per ordinary shares for the year/period represent net loss attributable to ordinary shareholders for the year/period excluding (i) share-based compensation expenses, and (ii) accretion of convertible redeemable preferred shares to redemption value. Share-based compensation expense is a non-cash expense arising from the grant of stock-based awards to employees. The Company believes that the exclusion of share-based compensation expenses from the net loss in the Reconciliation of GAAP and Non-GAAP Results assists management and investors in making meaningful period-to-period comparisons in the Company’s operating performance or peer group comparisons because (i) the amount of share-based compensation expenses in any specific period may not directly correlate to the Company’s underlying performance, (ii) such expenses can vary significantly between periods as a result of the timing of grants of new stock-based awards, and (iii) other companies may use different forms of employee compensation or different valuation methodologies for their share-based compensation.

Please see the “Reconciliation of GAAP and Non-GAAP Results” included in this press release for a full reconciliation of non-GAAP net loss and non-GAAP net loss per ordinary shares for the year/period for the year/period to net loss attributable to ordinary shareholders for the year/period.

About Adagene

Adagene Inc. (Nasdaq: ADAG) is a platform-driven, clinical-stage biopharmaceutical company committed to transforming the discovery and development of novel antibody-based cancer immunotherapies. Adagene combines computational biology and artificial intelligence to design novel antibodies that address unmet patient needs. Powered by its proprietary DPL platform, composed of NEObody, SAFEbody™, and POWERbody™ technologies, Adagene’s highly differentiated pipeline features novel immunotherapy programs. Adagene has forged strategic collaborations with reputable global partners that leverage its technology in multiple approaches at the vanguard of science.

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

Safe Harbor Statement

This press release contains forward-looking statements, including statements regarding the potential implications of clinical data for patients, and Adagene’s advancement of, and anticipated preclinical activities, clinical development, regulatory milestones, and commercialization of its product candidates. Actual results may differ materially from those indicated in the forward-looking statements as a result of various important factors, including but not limited to Adagene’s ability to demonstrate the safety and efficacy of its drug candidates; the clinical results for its drug candidates, which may not support further development or regulatory approval; the content and timing of decisions made by the relevant regulatory authorities regarding regulatory approval of Adagene’s drug candidates; Adagene’s ability to achieve commercial success for its drug candidates, if approved; Adagene’s ability to obtain and maintain protection of intellectual property for its technology and drugs; Adagene’s reliance on third parties to conduct drug development, manufacturing and other services; Adagene’s limited operating history and Adagene’s ability to obtain additional funding for operations and to complete the development and commercialization of its drug candidates; Adagene’s ability to enter into additional collaboration agreements beyond its existing strategic partnerships or collaborations, and the impact of the COVID-19 pandemic on Adagene’s clinical development, commercial and other operations, as well as those risks more fully discussed in the “Risk Factors” section in Adagene’s filings with the U.S. Securities and Exchange Commission. All forward-looking statements are based on information currently available to Adagene, and Adagene undertakes no obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events or otherwise, except as may be required by law.

Internal Contact:
Ami Knoefler
Adagene
650-739-9952
[email protected]

External Contact:
Bruce Mackle
LifeSci Advisors
646-889-1200
[email protected]

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 )

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Artificial Intelligence

IBM, Government of Canada, Government of Quebec Sign Agreements to Strengthen Canada’s Semiconductor Industry

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Up to $187M CAD to be invested to progress expansion of chip packaging capacity and capabilities and to strengthen R&D at IBM Canada’s Bromont plant
BROMONT, QC, April 26, 2024 /PRNewswire/ — IBM (NYSE: IBM), the Government of Canada, and the Government of Quebec today announced agreements that will strengthen Canada’s semiconductor industry, and further develop the assembly, testing and packaging (ATP) capabilities for semiconductor modules to be used across a wide range of applications including telecommunications, high performance computing, automotive, aerospace & defence, computer networks, and generative AI, at IBM Canada’s plant in Bromont, Quebec. The agreements reflect a combined investment valued at approximately $187M CAD.

“Today’s announcement is a massive win for Canada and our dynamic tech sector. It will create high-paying jobs, invest in innovation, strengthen supply chains, and help make sure the most advanced technologies are Canadian-made. Semiconductors power the world, and we’re putting Canada at the forefront of that opportunity,” said the Right Honourable Justin Trudeau, Prime Minister of Canada
In addition to the advancement of packaging capabilities, IBM will be conducting R&D to develop methods for scalable manufacturing and other advanced assembly processes to support the packaging of different chip technologies, to further Canada’s role in the North American semiconductor supply chain and expand and anchor Canada’s capabilities in advanced packaging.
The agreements also allow for collaborations with small and medium-sized Canadian-based enterprises with the intent of fostering the development of a semiconductor ecosystem, now and into the future.
“IBM has long been a leader in semiconductor research and development, pioneering breakthroughs to meet tomorrow’s challenges. With the demand for compute surging in the age of AI, advanced packaging and chiplet technology is becoming critical for the acceleration of AI workloads,” said Darío Gil, IBM Senior Vice President and Director of Research. “As one of the largest chip assembly and testing facilities in North America, IBM’s Bromont facility will play a central role in this future. We are proud to be working with the governments of Canada and Quebec toward those goals and to build a stronger and more balanced semiconductor ecosystem in North America and beyond.”
IBM Canada’s Bromont plant is one of North America’s largest chip assembly and testing facilities, having operated in the region for 52 years. Today, the facility transforms advanced semiconductor components into state-of-the-art microelectronic solutions, playing a key role in IBM’s semiconductor R&D leadership alongside IBM’s facilities at the Albany NanoTech Complex and throughout New York’s Hudson Valley. These agreements will help to further establish a corridor of semiconductor innovation from New York to Bromont. 
“Advanced packaging is a crucial component of the semiconductor industry, and IBM Canada’s Bromont plant has led the world in this process for decades,” said Deb Pimentel, president of IBM Canada. “Building upon IBM’s 107-year legacy of technology innovation and R&D in Canada, the Canadian semiconductor industry will now become even stronger, allowing for robust supply chains and giving Canadians steady access to even more innovative technologies and products. This announcement represents just one more example of IBM’s leadership and commitment to the country’s technology and business landscape.”
Chip packaging, the process of connecting integrated circuits on a chip or circuit board, has become more complex as electronic devices have shrunk and the components of chips themselves get smaller and smaller. IBM announced the world’s first 2 nanometer chip technology in 2021 and, as the semiconductor industry moves towards new methods of chip construction, advances in packaging will grow in importance. 
“Semiconductors are part of our everyday life. They are in our phones, our cars, and our appliances. Through this investment, we are supporting Canadian innovators, creating good jobs, and solidifying Canada’s semiconductor industry to build a stronger economy. Canada is set to play a larger role in the global semiconductor industry thanks to projects like the one we are announcing today. Because, when we invest in semiconductor and quantum technologies, we invest in economic security.”  — The Honourable François-Philippe Champagne, Minister of Innovation, Science and Industry
“This investment by IBM in Bromont will ensure that Quebec continues to stand out in the field of microelectronics. An increase in production capacity will solidify Quebec’s position in the strategic microelectronics sector in North America.” — The Honourable Pierre Fitzgibbon, Minister of Economy, Innovation and Energy, Minister responsible for Regional Economic Development and Minister responsible for the Metropolis and the Montreal region
About IBMIBM is a leading provider of global hybrid cloud and AI, and consulting expertise. We help clients in more than 175 countries capitalize on insights from their data, streamline business processes, reduce costs and gain the competitive edge in their industries. More than 4,000 government and corporate entities in critical infrastructure areas such as financial services, telecommunications and healthcare rely on IBM’s hybrid cloud platform and Red Hat OpenShift to affect their digital transformations quickly, efficiently and securely. IBM’s breakthrough innovations in semiconductors, AI, quantum computing, industry-specific cloud solutions and consulting deliver open and flexible options to our clients. All of this is backed by IBM’s legendary commitment to trust, transparency, responsibility, inclusivity and service. Visit www.ibm.com for more information. 
Media ContactLorraine BaldwinIBM [email protected] 
Willa HahnIBM [email protected]
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HITACHI ACQUIRES MA MICRO AUTOMATION OF GERMANY IN EFFORT TO ACCELERATE GLOBAL EXPANSION OF ROBOTIC SI BUSINESS IN THE MEDICAL AND OTHER FIELDS

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HOLLAND, Mich., April 26, 2024 /PRNewswire/ — Hitachi Ltd. (TSE: 6501, “Hitachi”) has signed a stock purchase agreement on April 26 to acquire all shares of MA micro automation GmbH (“MA micro automation”, headquartered in St. Leon-Rot, Germany) from MAX Management GmbH (a subsidiary of MAX Automation SE). MA micro automation is a leading provider of robotic and automation technology (robotic SI) including high-speed linear handling systems, high-precision assembly lines, and high-speed vision inspection technology for Europe, North America, and Southeast Asia, for EUR 71.5M million. The transaction is expected to close in the second half of 2024, pending completion of the customary regulatory filings. After the acquisition is completed, MA micro automation will join JR Automation Technologies, LLC (“JR Automation”), a market leader in providing advanced automation solutions and digital technologies in the robotic system integration business for North America, Europe, and Southeast Asia as a continued effort to expand the company’s global presence.

MA micro automation is a technology leader for automation solutions within micro-assembly. Through its state-of-the-art proprietary high-speed and high-precision automation know-how, combined with unique optical image inspection capabilities, MA micro automation serves high-growth med-tech automation end-markets, covering the production, assembly, and testing medical and optical components including contact lenses, IVD and diabetes diagnostics consumables, and injection molding for medical use. The company was established in 2003 through a carve-out from Siemens*1 and since 2013 has been part of the MAX Automation group. 
JR Automation is a leading provider of intelligent automated manufacturing technology solutions, serving customers across the globe in a variety of industries including automotive, life sciences, e-mobility, consumer and industrial products. With over 20 locations between North America, Europe, and Southeast Asia, the leading integrator offers nearly 2 million square feet (185,806 sq. m) of available build and engineering floorspace. This acquisition allows JR Automation to further grow and strengthen both the company’s geographical footprint and their continued commitment on expanding support capabilities within the European region and medical market vertical.
“MA micro automation provides engineering, build and support expertise with established capabilities in complex vision applications, high-speed and high-precision automation technologies. When integrated with JR Automation’s uniform global process and digital technologies, this partnership will further enhance our ability to deliver added value and support to all of our customers worldwide and continue to grow our capabilities in the medical market,” says Dave DeGraaf, CEO of JR Automation. “As we integrate this new dimension, impressive talents and abilities of the MA micro automation team we further enhance our ability to serve our customers, creating a more robust and globally balanced offering.”
With this acquisition, Hitachi aims to further enhance its ability to provide a “Total Seamless Solution*2” to connect manufacturer’s factory floors seamlessly and digitally with their front office data, allowing them to achieve total optimization and bringing Industry 4.0 to life. This “Total Seamless Solution” strategy links organizations’ operational activities such as engineering, supply chain, and purchasing to the plant floor and allows for real time, data-driven decision-making that improves the overall business value for customers.
Kazunobu Morita, Vice President and Executive Officer, CEO of Industrial Digital Business Unit, Hitachi, Ltd. says, “We are very pleased to welcome MA micro automation to the Hitachi Group. The team is based in Europe, providing robotic SI to global medical device manufacturing customers with its high technological capabilities and will join forces with JR Automation and Hitachi Automation to strengthen our global competitiveness. Hitachi aims to enhance its ability to provide value to customers and grow alongside them by leveraging its strengths in both OT, IT, including robotic SI, and “Total Seamless Solution” through Lumada*3’s customer co-creation framework.”
Joachim Hardt, CEO MA micro automation GmbH says, “Following the successful establishment and growth of MA micro automation within the attractive automation market for medical technology products, we are now opening a new chapter. Our partnership with Hitachi will not only strengthen our global competitive position, but we will also benefit from joint technological synergies and a global market presence.  We look forward to a synergistic partnership with Hitachi and JR Automation.”
Outline of MA micro automation    
Name
MA micro automation GmbH
Head Office
St. Leon-Rot, Germany
Representative
Joachim Hardt (CEO)
Outline of Business
Automation solutions within micro-assembly
Total no. of Employees:
Approx. 200 (As of April 2024)
Founded
2003
Revenues (2023)
€ 46.5 million
Website

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*1
“Siemens” is a registered trademark or trademark of Siemens Trademark GmbH & Co. KG in the U.S. and other countries.
*2
“Total Seamless Solution” is a registered trademark of Hitachi, Ltd. in the U.S. and Japan.
*3
Lumada: A collective term for solutions, services and technologies based on Hitachi’s advanced digital technologies for creating value from customers’ data accelerating digital innovation. https://www.hitachi.com/products/it/lumada/global/en/index.html
About JR AutomationEstablished in 1980, JR Automation is a leading provider of intelligent automated manufacturing technology solutions that solve customers’ key operational and productivity challenges. JR Automation serves customers across the globe in a variety of industries, including automotive, life sciences, aerospace, and more.  
In 2019, JR Automation was acquired by Hitachi, Ltd. In a strategic effort towards offering a seamless connection between the physical and cyber space for industrial manufacturers and distributers worldwide. With this partnership, JR Automation provides customers a unique, single-source solution for complete integration of their physical assets and data information, offering greater speed, flexibility, and efficiencies towards achieving their Industry 4.0 visions. JR Automation employs over 2,000 people at 21 manufacturing facilities in North America, Europe, and Asia.  For more information, please visit www.jrautomation.com.   
About Hitachi, Ltd.Hitachi drives Social Innovation Business, creating a sustainable society through the use of data and technology. We solve customers’ and society’s challenges with Lumada solutions leveraging IT, OT (Operational Technology) and products. Hitachi operates under the 3 business sectors of “Digital Systems & Services” – supporting our customers’ digital transformation; “Green Energy & Mobility” – contributing to a decarbonized society through energy and railway systems, and “Connective Industries” – connecting products through digital technology to provide solutions in various industries. Driven by Digital, Green, and Innovation, we aim for growth through co-creation with our customers. The company’s revenues as 3 sectors for fiscal year 2023 (ended March 31, 2024) totaled 8,564.3 billion yen, with 573 consolidated subsidiaries and approximately 270,000 employees worldwide. For more information on Hitachi, please visit the company’s website at https://www.hitachi.com.
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$10 million Artificial Intelligence Mathematical Olympiad Prize appoints further advisory committee members

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D. Sculley, Kevin Buzzard, Leo de Moura, Lester Mackey and Peter J. Liu appointed to the advisory committee for the Artificial Intelligence Mathematical Olympiad Prize.
LONDON, April 26, 2024 /PRNewswire/ — XTX Markets’ newly created Artificial Intelligence Mathematical Olympiad Prize (‘AIMO Prize’) is a $10mn challenge fund designed to spur the creation of a publicly shared AI model capable of winning a gold medal in the International Mathematical Olympiad (IMO).

XTX Markets is delighted to announce the appointment of five further advisory committee members. This group brings great expertise in machine learning, including D. Sculley, the CEO of Kaggle; Lester Mackey, a Principal Researcher at Microsoft Research and a Macarthur Fellow; and Peter J. Liu, a research scientist at Google DeepMind.
Prolific mathematicians Kevin Buzzard, who achieved a perfect score in the International Mathematical Olympiad, and Leo De Moura who is the Chief Architect for Lean, the automated reasoning tool, also join the advisory group.
They join the existing advisory committee members Terence Tao and Timothy Gowers, both winners of the Fields Medal, as well as Dan Roberts, Geoff Smith and Po-Shen Loh.
The AIMO Advisory Committee will support the development of the AIMO Prize, including advising on appropriate protocols and technical aspects, and designing the various competitions and prizes.
Simon Coyle, Head of Philanthropy at XTX Markets, commented:
“We are thrilled to complete the AIMO Advisory Committee with the appointments of D., Kevin, Leo, Lester and Peter. Together, they have enormous experience in machine learning and automated reasoning and are already bringing expertise and wisdom to the AIMO Prize. We look forward to announcing the winners of the AIMO’s first Progress Prize soon, and then publicly sharing the AI models to support the open and collaborative development of AI.”
Further information on the AIMO Prize
There will be a grand prize of $5mn for the first publicly shared AI model to enter an AIMO approved competition and perform at a standard equivalent to a gold medal in the IMO. There will also be a series of progress prizes, totalling up to $5mn, for publicly shared AI models that achieve key milestones towards the grand prize.
The first AIMO approved competition opened to participants in April 2024 on the Kaggle competition platform. The first progress prize focuses on problems pitched at junior and high-school level maths competitions. There is a total prize pot of $1.048m for the first progress prize, of which at least $254k will be awarded in July 2024, There will be a presentation of progress held in Bath, England in July 2024, as part of the 65th IMO.
For more information on the AIMO Prize visit: https://aimoprize.com/ or the competition page on Kaggle: https://www.kaggle.com/competitions/ai-mathematical-olympiad-prize/
Advisory Committee member profiles:
D. Sculley
D. is the CEO at Kaggle. Prior to joining Kaggle, he was a director at Google Brain, leading research teams working on robust, responsible, reliable and efficient ML and AI. In his career in ML, he has worked on nearly every aspect of machine learning, and has led both product and research teams including those on some of the most challenging business problems. Some of his well-known work involves ML technical debt, ML education, ML robustness, production-critical ML, and ML for scientific applications such as protein design.
Kevin Buzzard
Kevin a professor of pure mathematics at Imperial College London, specialising in algebraic number theory. As well as his research and teaching, he has a wide range of interests, including being Deputy Head of Pure Mathematics, Co-Director of a CDT and the department’s outreach champion. He is currently focusing on formal proof verification, including being an active participant in the Lean community. From October 2024, he will be leading a project to formalise a 21st century proof of Fermat’s Last Theorem. Before joining Imperial, some 20 years ago, he was a Junior Research Fellow at the University of Cambridge, where he had previously been named ‘Senior Wrangler’ (the highest scoring undergraduate mathematician). He was also a participant in the International Mathematical Olympiad, winning gold with a perfect score in 1987. He has been a visitor at the IAS in Princeton, a visiting lecturer at Harvard, has won several prizes both for research and teaching, and has given lectures all over the world.
Leo de Moura
Leo is a Senior Principal Applied Scientist in the Automated Reasoning Group at AWS. In his spare time, he dedicates himself to serving as the Chief Architect of the Lean FRO, a non-profit organization that he proudly co-founded alongside Sebastian Ullrich. He is also honoured to hold a position on the Board of Directors at the Lean FRO, where he actively contributes to its growth and development. Before joining AWS in 2023, he was a Senior Principal Researcher in the RiSE group at Microsoft Research, where he worked for 17 years starting in 2006. Prior to that, he worked as a Computer Scientist at SRI International. His research areas are automated reasoning, theorem proving, decision procedures, SAT and SMT. He is the main architect of several automated reasoning tools: Lean, Z3, Yices 1.0 and SAL. Leo’s work in automated reasoning has been acknowledged with a series of prestigious awards, including the CAV, Haifa, and Herbrand awards, as well as the Programming Languages Software Award by the ACM. Leo’s work has also been reported in the New York Times and many popular science magazines such as Wired, Quanta, and Nature News.
Lester Mackey
Lester Mackey is a Principal Researcher at Microsoft Research, where he develops machine learning methods, models, and theory for large-scale learning tasks driven by applications from climate forecasting, healthcare, and the social good. Lester moved to Microsoft from Stanford University, where he was an assistant professor of Statistics and, by courtesy, of Computer Science. He earned his PhD in Computer Science and MA in Statistics from UC Berkeley and his BSE in Computer Science from Princeton University. He co-organized the second place team in the Netflix Prize competition for collaborative filtering; won the Prize4Life ALS disease progression prediction challenge; won prizes for temperature and precipitation forecasting in the yearlong real-time Subseasonal Climate Forecast Rodeo; and received best paper, outstanding paper, and best student paper awards from the ACM Conference on Programming Language Design and Implementation, the Conference on Neural Information Processing Systems, and the International Conference on Machine Learning. He is a 2023 MacArthur Fellow, a Fellow of the Institute of Mathematical Statistics, an elected member of the COPSS Leadership Academy, and the recipient of the 2023 Ethel Newbold Prize.
Peter J. Liu
Peter J. Liu is a Research Scientist at Google DeepMind in the San Francisco Bay area, doing machine learning research with a specialisation in language models since 2015 starting in the Google Brain team. He has published and served as area chair in top machine learning and NLP conferences such as ICLR, ICML, NEURIPS, ACL and EMNLP. He also has extensive production experience, including launching the first deep learning model for Gmail Anti-Spam, and using neural network models to detect financial fraud for top banks. He has degrees in Mathematics and Computer Science from the University of Toronto.
About XTX Markets:
XTX Markets is a leading financial technology firm which partners with counterparties, exchanges and e-trading venues globally to provide liquidity in the Equity, FX, Fixed Income and Commodity markets. XTX has over 200 employees based in London, Paris, New York, Mumbai, Yerevan and Singapore. XTX is consistently a top 5 liquidity provider globally in FX (Euromoney 2018-present) and is also the largest European equities (systematic internaliser) liquidity provider (Rosenblatt FY: 2020-2023).
The company’s corporate philanthropy focuses on STEM education and maximum impact giving (alongside an employee matching programme). Since 2017, XTX has donated over £100mn to charities and good causes, establishing it as a major donor in the UK and globally.
In a changing world XTX Markets is at the forefront of making financial markets fairer and more efficient for all.
 

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