A.History and Development of the Company We commenced our operations in November 2014, when our predecessor Third Venture Biopharma (Nanjing) Co., Ltd was established. Our company previously operated under the name I-Mab. I-Mab was established in June 2016 under the laws of the Cayman Islands as our offshore holding company. In July 2016, I-Mab established I-Mab Hong Kong, as its intermediary holding company. In August 2016, I-Mab Hong Kong established a wholly-owned PRC subsidiary, I-Mab Biopharma Co., Ltd. (later renamed to TJ Biopharma (Shanghai) Co. Ltd. and referred to herein as “TJBio Shanghai”). In September 2016, the assets and operations of Third Venture Biopharma (Nanjing) Co., Ltd were consolidated into TJBio Shanghai. In July 2017, I-Mab Hong Kong acquired a controlling interest in I-Mab Bio-tech (Tianjin) Co., Ltd., (“I-Mab Tianjin”), formerly known as Tasgen Bio-tech (Tianjin) Co., Ltd., a company focused on the chemistry, manufacturing and controls of biologics in China. Through an internal corporate restructuring, I-Mab Tianjin became the 100% owner of TJBio Shanghai in September 2017 and I-Mab Hong Kong acquired the remaining interest in I-Mab Tianjin in May 2018, becoming the 100% owner of I-Mab Tianjin. In February 2018, I-Mab Biopharma U.S. Limited (“I-Mab U.S.”) was established in Maryland, United States as a wholly-owned subsidiary of I-Mab Hong Kong and as the hub for the discovery and development of the drug candidates in our Global portfolio. On January 17, 2020, our ADSs commenced trading on the Nasdaq Global Market under the symbol “IMAB.” In 2020, we invested in a comprehensive biologics manufacturing facility in Hangzhou, China as part of our strategic plan to become a specialty biopharma company. The construction of this facility commenced in April 2021. This facility established a pilot capacity of two production lines. The project was financed by a combination of internal and external sources. In September 2020, a group of domestic investors in China invested a total of $120 million (in RMB equivalent) in cash. Upon the closing of this financing, we, through our wholly-owned subsidiary and parties acting in concert, were a majority shareholder of TJBio Hangzhou, the entity holding the facility in Hangzhou. On July 16, 2022, TJBio Hangzhou entered into a definitive financing agreement with a group of domestic investors in China to raise approximately $46 million (in RMB equivalent). Upon the closing of the financing, we, through our wholly-owned subsidiary, remained the largest shareholder of TJBio Hangzhou. Upon the occurrence of certain triggering events as specified in the shareholders agreement with TJBio Hangzhou, we became obligated to repurchase the equity held by other domestic investors in cash or in our securities if TJBio Hangzhou failed to accomplish certain public offering conditions. On February 6, 2024, in connection with the divestiture of our Greater China assets and business operations, we transferred the equity interests we held, through our wholly-owned subsidiary, in TJBio Hangzhou to certain participating shareholders of TJBio Hangzhou in exchange for the extinguishment of the existing repurchase obligations owed by I-Mab Hong Kong to those shareholders in the amount of approximately $183 million. We subsequently settled the remaining repurchase obligations of approximately $32 million through repurchase agreements with certain non-participating shareholders of TJBio Hangzhou by September 2024. Concurrently with the divestiture, we also participated in the Series C fundraising of TJBio Hangzhou with an additional investment of $19 million in the first quarter of 2024. See Note 8 – Investments and Put Right Liabilities to our consolidated financial statements included elsewhere in this annual report for additional information of our investment in TJBio Hangzhou. In October 2023, we divested our 51% equity interest in Zhejiang Tianli Pharmaceutical Sales Co., Ltd. previously held by I-Mab Biopharma Co., Ltd. On February 6, 2024, we entered into definitive agreements with TJBio Hangzhou and a group of China-based investors to divest our Greater China assets and business operations. Pursuant to the definitive agreements, we transferred 100% of the outstanding equity interest in TJBio Shanghai, that operated our business in China, on a cash-free and debt-free basis, to TJBio Hangzhou for an aggregate consideration of the RMB equivalent of up to $80 million, contingent on TJBio Hangzhou’s achievement of certain future regulatory and sales-based milestone events as well as royalties. We also retain a right of first negotiation outside of Greater China related to three future investigational new drug candidates. On October 28, 2025, our wholly-owned subsidiary I-Mab Hong Kong acquired 100% ownership of Bridge Health Biotech Co., Ltd (“Bridge Health”) pursuant to an equity purchase agreement. The transaction provides us with the rights worldwide, subject to a bispecific collaboration agreement with ABL Bio, Inc., (“ABL Bio”), to bispecific and multi-specific applications, including bispecific and multi-specific antibodies and antibody drug conjugates (“ADCs”), based on the Claudin 18.2 (“CLDN18.2”) parental antibody used 61 Table of Contents in givastomig. Pursuant to the equity purchase agreement, we agreed to pay Bridge Health shareholders an upfront payment in the amount of $1.8 million, and are obligated to make non-contingent payments totaling $1.2 million through 2027. In addition, Bridge Health shareholders may also receive future milestone payments of up to $3.875 million, subject to the achievement of certain development and regulatory milestones. On October 16, 2025, we announced the adoption of a new business model designed to identify and advance high-value therapeutic assets through strategic partnerships and specialized subsidiary entities. Under this model, we expect to transition into a biotechnology platform company which will establish separate subsidiaries responsible for the development of therapeutically focused assets to enhance oversight, operational focus, and risk management. In connection with our new business model, we announced the intent to file an application with the Stock Exchange of Hong Kong Limited (the “HKEX”) for a proposed dual primary listing by way of an initial public offering of our ordinary shares on the Main Board of the HKEX. We subsequently submitted a listing application on October 31, 2025. Under the new business model, we continue to commit to advancing core assets which include givastomig, a novel bispecific antibody (“bsAb”) simultaneously targeting CLDN18.2, a tumor associated antigen preferentially expressed in gastric, esophageal, and pancreatic cancers, and 4-1BB, a co-stimulatory molecule on T cells and VIS-101, a biologic targeting VEGF-A and ANG2 for patients with Wet AMD and DME. In October 2025, concurrent with the new business model announcement, we entered into a Series A preferred stock subscription agreement (the “Series A Subscription Agreement”) with our newly formed, wholly-owned subsidiary Visara, Inc. (“Visara”), pursuant to which we subscribed to 35,000,000 shares of Series A preferred stock of Visara for an aggregate purchase price of approximately $37.0 million. AffaMed Therapeutics (HK) Limited (“AffaMed”) subscribed to 16,150,000 shares of Series A preferred stock pursuant to the Series A Subscription Agreement. AffaMed’s subscription was made in exchange for the assignment of certain rights, title, and interest related to VIS-101 (also known as AM712 and ASKG712) in countries worldwide except for Singapore, Thailand, Malaysia, Indonesia, Vietnam, the People’s Republic of China, Taiwan, Macau, Hong Kong, Korea and India (the “ex-China Rights”). VIS-101 is a biologic targeting Vascular endothelial growth factor A (“VEGF-A”) and Angiopoietin-2 (“ANG-2”) for patients with wet age-related macular degeneration (“Wet AMD”) and diabetic macular edema (“DME”). In connection with the assignment of certain rights, title, and interest related to VIS-101, Visara made an upfront payment to AffaMed in the amount of $5.0 million. AffaMed is an affiliate of CBC Group, one of our principal shareholders. Additionally, Visara entered into an license agreement with AskGene Pharma, Inc. (“AskGene”) for an exclusive royalty-bearing license to develop VIS-101, in Singapore, Thailand, Malaysia, Indonesia, Vietnam, the People’s Republic of China, Taiwan, Macau, Hong Kong, Korea, and India (the “Asian Territories”) for an upfront payment in the amount of $7.0 million and reimbursement of certain costs incurred in connection with AskGene’s ongoing Phase 2a study and long-term toxicology study of VIS-101 up to an aggregate amount of RMB 24 million. Visara subsequently assigned its VIS-101 rights in the Asian Territories to Everest Medicines (Singapore) Pte. Ltd., (“Everest”) for an upfront payment in the amount of $7.0 million and assumption of all payment obligations under the license agreement between Visara and AskGene. Everest, an affiliate of CBC Group, and CBC Group are two of our principal shareholders. On October 24, 2025, our shareholders passed a special resolution to change our company’s name from “I-Mab” to “NovaBridge Biosciences”, effective on October 29, 2025. On October 30, 2025, following the name change, our ADSs began trading on the Nasdaq Global Market under the new ticker symbol “NBP”. Our principal executive offices are located at 2440 Research Boulevard, Suite 400, Rockville, MD 20850, the United States. Our telephone number at this address is (240) 745-6330. Our registered office in the Cayman Islands is located at Vistra (Cayman) Limited, P.O. Box 31119 Grand Pavilion, Hibiscus Way, 802 West Bay Road, Grand Cayman, KY1-1205, Cayman Islands. All information filed with the SEC can be obtained over the internet at SEC’s website at https://www.sec.gov. Our investors can also find information on our website https://www.novabridge.com/investors. The information contained on our website is not a part of this annual report. 62 Table of Contents B.Business Overview Executive Summary We are a global biotechnology platform company dedicated to bringing paradigm-shifting innovative treatments to the global markets in an accelerated and capital efficient manner. Since our inception, we have built a track record of identifying and developing novel and highly differentiated therapeutics worldwide. Leveraging our international infrastructure and industry-leading capabilities, we have established a distinctive value-creating platform to deliver innovation from emerging biopharma ecosystems to patients globally, while driving sustainable growth for shareholders. Our innovative immuno-oncology pipeline consists of three clinical stage programs, givastomig; uliledlimab; and ragistomig. Our core product, givastomig, is a potential best-in-class CLDN18.2 bispecific antibody for the treatment of gastric cancer and other CLDN18.2-positive gastrointestinal malignancies. Givastomig is being studied in a recently initiated global randomized, Phase 2 study in combination with nivolumab and chemotherapy versus nivolumab and chemotherapy in first-line metastatic gastric cancer. Givastomig is also being studied in an ongoing Phase 1b study in combination with nivolumab and chemotherapy in first-line gastric cancer. We provided an update on the dose expansion cohorts of the Phase 1b study in January of 2026, and we expect to provide further updates in the second half of 2026 at a medical conference. We anticipate launching additional studies in other Claudin 18.2-positive gastrointestinal malignancies during 2026. In connection with our 2025 Realignment Plan, we have paused internal development of uliledlimab while we await further data from TJ Biopharma’s ongoing, randomized Phase 2 study combining uliledlimab with a checkpoint inhibitor in China. The results of these studies will help inform any potential future development path of uliledlimab. Our third program, ragistomig, is managed by our collaboration partner, ABL Bio, who is currently conducting an ongoing Phase 1 study in multiple solid tumors. We, through our subsidiary Visara, acquired the rights to VIS-101, a highly differentiated VEGF-A × ANG-2 bispecific biologics in Phase 2 development for Wet AMD and other retinal diseases including DME. VIS-101 has completed Phase 1 trials for both Wet AMD and DME. Interim results of an ongoing randomized Phase 2 trial in Wet AMD show rapid vision improvement sustained beyond 16 weeks for more than half of the evaluable patients, suggesting best-in-class potential with superior durability to other approved VEGF-based therapies. Development efforts are led by the clinical team at Visara. Visara intends to initiate a Phase 3 study in the first half of 2027. The stage of development of our pipeline assets, including the progress in our ongoing clinical trials, is represented in the table below: 1.Givastomig also known as ABL111, ragistomig also known as ABL503 2.BMS agreed to manufacture, supply, and grant us a license to use nivolumab (OPDIVO®) in our Phase 1 trial to evaluate givastomig’s combination with nivolumab and mFOLFOX6 3.Trial conducted by TJ Biopharma, NCT04322006 4.Global rights, ex-Greater China, ex-South Korea 63 Table of Contents 5.Global rights, ex-Greater China Notes: mAb = monoclonal antibody; bsAb = bispecific antibody; 1L = first line; nivo = nivolumab; tori = toripalimab (TUOYI®); CPI = checkpoint inhibitor; GEA = gastroesophageal adenocarcinoma, including gastric cancer, gastroesophageal junction cancer, and esophageal adenocarcinoma; BTC = biliary tract cancer; PDAC = pancreatic ductal adenocarcinoma; NSCLC = non-small cell lung cancer; Wet AMD = wet age-related macular degeneration; DME = diabetic macular edema; FPI = first patient in; PD-(L)1 = inhibitors of PD-L1 or PD-1; CLDN18.2 = Claudin18.2; CLDN18.2 Low = CLDN18.2 < 75%; PD-L1 Low = CPS < 1. We made significant progress throughout the year in development of our global clinical pipeline assets: givastomig, uliledlimab, ragistomig, and VIS-101. Substantial achievements related to the development of our global clinical pipeline in 2025 included: 1)publication of the first-in-human monotherapy data for givastomig, in Clinical Cancer Research, a journal of the American Association for Cancer Research; 2)presented Phase 1b dose escalation data on givastomig in combination with immunochemotherapy at the Society for Medical Oncology Gastrointestinal Cancers Congress 2025 in Barcelona, Spain; 3)strengthened the intellectual property portfolio of givastomig through the acquisition of Bridge Health; 4)completed enrollment of the planned Phase 1b dose expansion cohorts evaluating givastomig, in combination with immunochemotherapy, ahead of expectations; 5)accelerated and expanded investment in givastomig program with plans to broaden the first-line development strategy into locally advanced gastric cancer as well as other Claudin 18.2-positive tumor types, including biliary tract cancer (BTC) and pancreatic ductal adenocarcinoma (“PDAC”); 6)presented an update on the Phase 1 study of givastomig as a monotherapy in heavily pre-treated patients with gastroesophageal carcinoma (“GEC”) at the AACR-NCI-EORTC conference; 7)formed Visara, Inc. to pursue the development of VIS-101, a biologic targeting VEGF-A and ANG-2, and a more potent molecule that could potentially provide more durable treatment benefits for patients with Wet AMD, DME, and retinal vein occlusion (“RVO”) than current standard of care; and 8)repurpose our company with a pivot of our business model, including a transition of corporate name and logo from I-Mab to NovaBridge Biosciences; and 9)presented new data from the expanded 3mg/kg every 6-week (“Q6W”) Phase 1 dosing study for ragistomig at the European Society for Medical Oncology – Immuno-Oncology Congress 2025 by co-developer ABL Bio. In January 2026, we presented positive Phase 1b dose expansion data on givastomig in combination with immunochemotherapy. We also achieved first patient dosed enrolled in the global, randomized Phase 2 study of givastomig in combination with immunochemotherapy in February 2026. In March 2026, we announced positive Phase 2a data on VIS-101 for the treatment of Wet AMD and reiterated our plan to initiate Phase 2b randomized trial in 2026. Our Drug Pipeline Givastomig (TJ-CD4B): A Novel 4-1BB Bispecific Antibody for CLDN18.2-Positive Gastric and Other Cancers Summary Givastomig (also known as “ABL111”, “TJ033721” and “TJCD4B”) is a bispecific antibody targeting Claudin18.2 (“CLDN18.2”), a tumor associated antigen preferentially expressed in gastric, esophageal, and pancreatic cancers, and 4-1BB, a co-stimulatory molecule on T cells adjacent to CLDN18.2-positive tumor cells. CLDN18.2 is a tight junction molecule normally restricted to epithelial cells of the gastric mucosa but becomes widely expressed on the cell surface in select tumors, such as gastric, esophageal, and pancreatic cancers, making it a highly attractive tumor target. Givastomig is being jointly developed through a global partnership with ABL Bio, in which we act as the lead party and we share worldwide rights equally with ABL Bio (50/50), excluding Greater China and South Korea. Givastomig has two key advantages over current CLDN18.2 antibodies and 4-1BB agonistic antibodies. First, givastomig has a high affinity for CLDN18.2 and thus can bind to tumor cells with very low levels of CLDN18.2 expression, making it potentially applicable to a broader patient population with a wide range of CLDN18.2. Second, only upon tumor cell engagement by givastomig are T cells stimulated by the 4-1BB antibody moiety, making the 4-1BB antibody arm only active at the tumor site. This localized T cell activation 64 Table of Contents is conditional upon CLDN18.2 engagement and is expected to exert strong anti-tumor activity while minimizing systemic side effects such as liver toxicity commonly seen with 4-1BB agents in previous preclinical studies and clinical trials. In March 2022, we announced that the U.S. FDA granted givastomig Orphan Drug Designation for the treatment of gastric cancer, including gastroesophageal junction carcinoma. In October 2023, we presented the topline Phase 1 data of givastomig with promising early efficacy signals, including patients with low levels of CLDN18.2 tumor expression, at the European Society for Medical Oncology (“ESMO”) annual meeting. Phase 1 dose escalation reached the highest planned dose level. Most treatment-related adverse events were low-grade. Positive monotherapy efficacy results were observed, including in tumors with lower levels of CLDN18.2 expression, in patients with previously treated cancer that has relapsed or progressed after prior standard treatments. In September 2024, we presented updated safety and expanded efficacy data from the Phase 1 trial of givastomig as monotherapy in CLDN18.2-positive advanced GEC, at ESMO 2024. An overall response rate (“ORR”) of 16.3% (7/43) was observed in a total of 43 heavily pre-treated patients (at least two prior lines of therapy) with CLDN18.2-positive (1+ intensity in ≥1% of cells) GEC, who received givastomig at doses ranging from 5 to 18 mg/kg. A favorable safety profile, with mainly grade 1 or 2 treatment-related adverse events (“TRAEs”) and no observations of dose-limiting toxicities (“DLTs”) or identification of a maximum tolerated dose (“MTD”) suggested the feasibility of further investigation of combinations with other agents. In January 2025, based on monotherapy data with givastomig demonstrating clinical activity and a favorable toxicity, as well as early encouraging efficacy data in the Phase 1b dose escalation study combining givastomig with front line (1L), standard of care, nivolumab and chemotherapy (mFOLFOX6), we announced a re-prioritization of resources, with a focus on advancing givastomig as our lead clinical program. We are continuing to sponsor the Phase 1b dose escalation and dose expansion trials of givastomig in combination with nivolumab and chemotherapy in patients with CLDN18.2-positive (1+ intensity in ≥1% of cells) treatment-naïve gastric, gastroesophageal junction and esophageal cancer at United States based investigational sites. We believe front-line gastric cancer is an area of high unmet medical need, and the ability to combine a novel immunostimulant such as givastomig with standard of care therapies that include checkpoint inhibitors and chemotherapy regimens has the potential to transform clinical care of these patients. In parallel, we are developing a CLDN18.2 immunohistochemistry assay for patient selection and are exploring potential global partnership opportunities for givastomig. In July 2025, we presented positive givastomig dose escalation data from the Phase 1b combination study in patients with 1L gastric cancer at the ESMO GI annual meeting. A confirmed ORR of 71% (12/17) across all doses givastomig (5 mg/kg, 8 mg/kg and 12 mg/kg) when combined with nivolumab and chemotherapy, and 83% (10/12) at doses selected for the ongoing dose expansion study (8 mg/kg and 12 mg/kg) were observed in patients with 1L HER2-negative, Claudin 18.2-positive gastric cancers (≥1+ IHC staining intensity in ≥1% of tumor cells). Responses occurred in tumors with low levels of programmed cell death ligand (“PD-L1”) expression and/or Claudin 18.2 expression, with favorable overall tolerability. A maximum tolerated dose and dose limiting toxicities were not identified. There were no Grade 3 or greater events for nausea and vomiting, and only one Grade 3 TRAE for increased liver enzymes. In the second half of 2025, new cohorts were added to the current phase 1b study to study the givastomig combination in biomarker subgroups and other CLDN18.2-positive gastrointestinal (GI) malignancies based on the encouraging dose escalation data. The enrollment of a cohort of 20 patients with low CLDN18.2 expression (≥1+ IHC staining intensity in <75% of tumor cells) and PD-L1 CPS≥1 was initiated in October 2025. The enrollment of a “double-low” cohort (low CLDN18.2 and low PD-L1 expression) combining givastomig with chemotherapy was initiated in November 2025. Additional cohorts of patients with CLDN18.2-positive biliary tract carcinoma and pancreatic ductal adenocarcinoma were also added to further explore givastomig’s potential when added to 1L SoC in these malignancies. In January 2026, we released positive givastomig dose expansion data from the ongoing Phase 1b combination study in patients with 1L HER2-negative, Claudin 18.2-positive gastric cancers (≥1+ IHC staining intensity in ≥1% of tumor cells). These data confirmed and extended the data presented in July 2025. Givastomig continued to show robust efficacy when combined with nivolumab and chemotherapy with a 77% ORR observed at 8 mg/kg and a 73% ORR observed at 12 mg/kg, across a wide range of PD-L1 and CLDN18.2 expression. The median progression free survival (“mPFS”) was 16.9 months at 8 mg/kg; mPFS at 12 mg/kg was still maturing due to sequential enrollment of this cohort and the resultant approximately 4-month shorter median follow-up. The combination was well tolerated, and the overall safety profile is comparable to the current standard of care treatment. 65 Table of Contents 1.The 12 mg/kg cohort includes one additional patient for survival analysis who was ineligible for response analysis. Table: Efficacy summary table of givastomig (8 & 12 mg/kg) combination study in efficacy evaluable patients Together, these data support that givastomig is a potential best-in-class CLDN18.2 asset when added to 1L standard of care. Detailed Phase 1b dose expansion data are expected to be presented at a medical conference later in 2026. First dosing of a global, randomized Phase 2 study, evaluating both doses against standard of care, was completed in February 2026. Recent interactions with the FDA have identified potential paths for accelerated approval for givastomig in combination with immunochemotherapy in 1L GEC. Benchmarks for technical success were identified. These benchmarks for success have been incorporated into a Phase 3 design that will be presented to the FDA for endorsement. Therapeutic Indications Gastric cancer is one of the leading causes of cancer-related deaths worldwide. Treatment for advanced gastric, gastroesophageal junction, or esophageal adenocarcinoma often involves a combination of chemotherapy and recently, immune therapies (checkpoint inhibitors). However, the clinical benefit remains modest with the current therapies. Therefore, there is a significant unmet medical need as patients with metastatic cancer have a low survival rate. According to epidemiology data provided by Data Monitor Biomed Tracker, the annual incidence of gastric cancer in the United States, France, Germany, Italy, Spain, the United Kingdom (formerly known as the “5 E.U.”), and Japan was estimated to be approximately 250,000 patients. Of these, we estimate based on screening data that approximately 78% or 195,000 patients are HER2-negative. Within that population it is estimated that approximately 70% or 136,500 patients are CLDN18.2-positive. Our current clinical program focuses on HER2-negative, CLDN18.2-positive populations in gastric cancer. Zolbetuximab-clzb (“zolbetuximab”) was recently approved by the FDA for first-line treatment of adults with locally advanced unresectable or metastatic HER2-negative gastric or gastro-esophageal junction adenocarcinoma whose tumors are CLDN18.2-positive in combination with chemotherapy alone. CLDN18.2 positivity is defined as ≥75% of tumor cells demonstrating moderate to strong membranous CLDN18 staining (2+ or 3+ intensity). While zolbetuximab provides an option for patients with advanced gastric cancer who express very high levels of CLDN18.2, it is important to highlight the significant percentage of patients (~70%) who are not eligible for zolbetuximab based on CLDN18.2 expression levels. There are no approved treatments for CLDN18.2 expression levels below 75%. This represents a large opportunity for CLDN18.2-directed therapeutic approaches that broaden the patient population across a wider range of CLDN18.2 expression levels. 66 Table of Contents 1.Markets include U.S., 5 E.U. countries and Japan in 2025 based on Data Monitor Biomed Tracker. 2.HER2-negative status of 78%. Van Cutsem E, Bang YJ, Feng-Yi F, et al. HER2 screening data from ToGA: targeting HER2 in gastric and gastroesophageal junction cancer. Gastric Cancer 2015;18(3):476-84. 3.CLDN18.2-positive status of ~70%. Kohei Shitara, et al, 2023 ASCO Annual Meeting (June 2-6), poster #4035. 4.VYLOY (zolbetuximab-clzb) FDA label. Notes: CPS = combined positive score; BIC = best-in-class; FIC = first-in-class; 1L = first-line. CLDN18.2 protein is not only highly expressed in gastric cancers but also detected at various levels in other gastrointestinal malignancies. Therefore, givastomig in combination with other anti-cancer therapies may warrant further investigation based on the biological rationale and CLDN18.2 prevalence. In addition, givastomig may have potential benefits for early-stage cancers in the neoadjuvant setting. In essence, any stage and any tumor type that may have CLDN18.2 expression and is treated with standard of care that involves a checkpoint inhibitor +/- chemotherapy may benefit from the addition of givastomig. Potential Differentiation of Givastomig Givastomig is a novel bispecific antibody, with one arm targeting CLDN18.2 and the other targeting 4-1BB through conditional local activation. The key differentiation of givastomig is two-fold. First, it binds to tumors with a wide range of CLDN18.2 expression levels, as demonstrated in preclinical animal models. Second, the 4-1BB arm of givastomig is designed to function upon local tumor engagement as a mechanism of conditional immune activation. This feature makes givastomig a unique T cell activator only localized at the tumor site, reducing the risk of systemic toxicities, e.g., liver toxicity and systemic cytokine release, which are typically associated with 4-1BB. In support of the conditional activation, givastomig exhibits less gastrointestinal toxicity than is commonly observed for other CLDN18.2 targeted therapeutics. Moreover, unlike previous generations of 4-1BB agonist antibodies with hepatotoxicity issues, givastomig binds to a distinct 4-1BB epitope that only triggers 4-1BB signaling upon CLDN18.2 target engagement but not Fc receptor interaction. This unique tumor-associated antigen-dependent property is expected to drastically reduce peripheral T cell activation and hepatic and systemic immunotoxicity without compromising anti-tumor activity. If continued to be proven in the clinic, these properties enable givastomig to be highly differentiated from other CLDN18.2-based compounds. 67 Table of Contents Figure: Schematic diagram of the overall structure of givastomig and its components. The 4-1BB agonistic antibody is a single-chain Fv connected to the C-terminus of a disabled Fc in a full anti-CLDN18.2 antibody via a flexible linker. The design allows the molecule to fit in the immune synapse (left) and trans-activate T cells only upon tumor cell binding. As shown in the figure below, givastomig consistently exhibited stronger binding than the reference antibody zolbetuximab in cells with high, moderate, and even low levels of CLDN18.2. Figure: More potent binding by givastomig than zolbetuximab to cells expressing various levels of CLDN18.2. The ability of givastomig to ligate 4-1BB and activate downstream signaling was tested in CLDN18.2-positive or negative target cells co-cultured with T cells as effectors. The results in the figure show that givastomig elicited the strongest 4-1BB-mediated NF-kB reporter activity, but only in the presence of CLDN18.2-positive cells and not CLDN18.2-negative cells. In contrast, urelumab (a first generation 4-1BB antibody) induced NF-kB reporter activity regardless of target cell CLDN18.2 expression. In another experiment where human peripheral blood mononuclear cells were co-cultured with gastric cancer cells derived from patient biopsies, givastomig was found to increase IL-2 production in a dose-dependent and CLDN18.2 expression-dependent manner. 68 Table of Contents Figure: Dose-dependent CLDN18.2-restricted T cell activity by givastomig but not urelumab in T cell and target cell co-culture system. Left, co-culture scheme; Middle, NF-kB reporter activity; Right, IL-2 production. In transgenic mice expressing human 4-1BB that were engrafted with tumor cells expressing human CLDN18.2, givastomig treatment twice a week for three weeks suppressed tumor cell growth in six out of seven mice, delivering better efficacy than equimolar doses of single agent drugs targeting CLDN18.2 or 4-1BB alone or in combination. When these tumor-free mice were re-challenged with a second tumor implant a month after drug cessation, they remained protected from tumor implantation, indicating that givastomig produced a durable anti-tumor response. Immune cell analysis revealed a significant increase in CD45-positive and CD8-positive T cells that infiltrated the tumor tissue after givastomig treatment, but there were no changes in the periphery, suggesting that givastomig could turn a cold tumor into a hot tumor, and the effect was localized. The anti-tumor efficacy of givastomig was dose-dependent, with a minimal efficacious dose of 0.4 mg/kg. Figure: Potent in vivo anti-tumor activity of givastomig in a mouse tumor model. Mice transgenic for humanized 4-1BB were grafted with MC38 cells expressing human CLDN18.2. Mice were treated with IgG or zolbetuximab as control, or with parental CLDN18.2 mAb, parental 4-1BB mAb, or both, and with givastomig (4 mg/kg) twice a week for three weeks. All mAbs were dosed at the molar equivalent of 3 mg/kg. Preclinical Pharmacodynamics and Safety The pharmacodynamic data and safety of givastomig in animal models and cell cultures were jointly announced by us and ABL Bio at the 2021 SITC annual meeting. Analysis of the data found: (1) potent anti-tumor activity was observed with the proliferation of immune cells in the tumor microenvironment, as well as an increase in memory T cells in the peripheral blood, suggesting long-term immunity against the tumor; (2) givastomig was well tolerated in non-human primates and did not induce a systemic immune response 69 Table of Contents or liver toxicity up to levels of 100mg/kg; and (3) activation of immune pathways by givastomig was demonstrated by a pro-inflammatory profile and increased gamma interferon-regulated gene expression in primary human CD8-positive T cells co-cultured with CLDN18.2 expressing cells. In the four-week good laboratory practice monkey toxicity study, givastomig was well tolerated with no major findings. There was no liver toxicity noted, nor was there evidence of systemic immune activation. There were mild stomach changes that were considered on-target but non-adverse and were reversible. The no observed adverse effect level (“NOAEL”) was determined to be 100 mg/kg. Summary of Clinical Results Phase 1 clinical trial of givastomig monotherapy in patients with advanced or metastatic solid tumors The Phase 1 monotherapy study consists of a dose escalation phase irrespective of CLDN18.2 expression status followed by dose expansion cohorts in CLDN18.2-positive patients. The dose escalation part of the Phase 1 trial of givastomig monotherapy in patients with advanced solid tumors reached a dose of 15 mg/kg without a dose limiting toxicity. By the end of 2022, eight dose cohorts had been completed, with 38 subjects dosed. Givastomig was well tolerated, most of the treatment-related adverse events were grade 1 or 2 and no dose limiting toxicity was reported. There was a dose-dependent increase of drug exposure and soluble 4-1BB in serum, suggestive of a favorable pharmacokinetic/pharmacodynamic profile with durable T cell activation. Partial responses and stable disease were observed across several dose levels in patients with gastric and esophageal cancer whose cancer had progressed after multiple lines of prior therapies, including PD-1 therapy. Efficacy signals were also observed in patients with low CLDN18.2 expression, highlighting its potential to treat CLDN18.2 low-expressing tumors where other CLDN18.2 targeted agents have shown a limited treatment effect. In October 2023 at the ESMO annual meeting, we presented updated topline Phase 1 data of givastomig that confirmed promising early efficacy signals, including signals in patients with low levels of CLDN18.2 tumor expression. Phase 1 dose escalation has reached the highest planned dose level. Most treatment-related adverse events were low-grade. In this trial, positive monotherapy efficacy results were observed, including in tumors with lower levels of CLDN18.2 expression. Updated safety and efficacy data of givastomig monotherapy in patients with CLDN18.2-positive advanced GEC In October 2025, at AACR-NCI-EORTC annual meeting, a total of 45 patients with CLDN18.2-positive GEC were enrolled and received givastomig at 5 mg/kg (n=7), 8 mg/kg (n=5), 12 mg/kg (n=21) and 15 mg/kg (n=6) Q2W, and 18 mg/kg (n=6) Q3W. Of the 45 efficacy-evaluable patients, a confirmed ORR of 18% (8/45) was observed with a partial response in seven patients (one at 5 mg/kg, one at 8 mg/kg, four at 12 mg/kg and two at 18 mg/kg). Stable disease was reported in 14 patients, with a disease control rate (“DCR”) of 49% (22/45). CLDN18.2 expression in responders ranged from 11% to 100%. Additionally, five responders had received prior treatment with PD-(L)1 inhibitors. A favorable safety profile, with mainly grade 1 or 2 TRAE and no observations of DLT or identification of an MTD supports further investigation of givastomig in combination with other agents. Table: Efficacy summary table of givastomig (5-18 mg/kg) in CLDN18.2-positive GEC 70 Table of Contents Phase 1b Combination Study in patients with 1L HER2-negative and CLDN18.2-positive metastatic GEC Safety and efficacy data of givastomig dose escalation data from the Phase 1b combination study In July 2025, at the ESMO GI annual meeting, we presented positive givastomig dose escalation data from the Phase 1b combination study in 17 patients with frontline gastric cancer. A confirmed ORR of 71% (12/17) across all doses givastomig (5 mg/kg, 8 mg/kg and 12 mg/kg) when combined with nivolumab and chemotherapy, and 83% (10/12) at doses selected for the ongoing dose expansion study (8 mg/kg and 12 mg/kg) were observed in patients with 1L HER2-negative, Claudin 18.2-positive gastric cancers (≥1+ IHC staining intensity in ≥1% of tumor cells). Responses occurred in tumors with low levels of PD-L1 expression and/or Claudin 18.2 CLDN18.2 expression, with favorable overall tolerability. There were no Grade 3 or greater events of nausea and vomiting, and only one Grade 3 TRAE of increased ALT and AST. Safety and efficacy data of givastomig expansion data from the Phase 1b combination study In January 2026, we released positive givastomig dose expansion data from the ongoing Phase 1b combination study in patients with 1L HER2-negative, Claudin 18.2-positive gastric cancers (≥1+ IHC staining intensity in ≥1% of tumor cells). These data confirmed and extended the data presented in July 2025. Givastomig continued to show robust efficacy when combined with nivolumab and chemotherapy with 77% ORR observed at 8 mg/kg and 73% ORR observed at 12 mg/kg, across a wide range of PD-L1 and CLDN18.2 expression levels. The mPFS was 16.9 months at 8 mg/kg; mPFS at 12 mg/kg was still maturing due to sequential enrollment of this cohort and the resultant approximately 4-month shorter median follow-up. The combination was well tolerated, and the overall safety profile is comparable to the current standard of care treatment. These data demonstrate that givastomig is a potential best-in-class CLDN18.2 asset when added to 1L standard of care. 1.The 12 mg/kg cohort includes one additional patient for survival analysis who was ineligible for response analysis. Table: Efficacy summary table of givastomig (8 & 12 mg/kg) combination study in efficacy evaluable patients Clinical Development Plan Based on the monotherapy data and positive data from the ongoing Phase 1b 1L combination study with nivolumab and chemotherapy, we are focusing our resources on advancing givastomig as our lead asset in 1L GEC as well as other CLDN18.2-positive gastrointestinal malignancies. We are continuing to sponsor the Phase 1b dose escalation and dose expansion cohorts of givastomig in combination with standard of care, nivolumab and chemotherapy, in patients with CLDN18.2-positive (1+ intensity in ≥1% of cells) treatment naïve gastric, gastroesophageal junction and esophageal cancer. Multiple new cohorts were added to the current Phase 1b study to confirm the efficacy signal in biomarker-selected subgroups and explore givastomig’s efficacy signal in other CLDN18.2-positive GI malignancies, including biliary tract carcinoma and pancreatic ductal adenocarcinoma. In order to confirm the differentiation of givastomig’s efficacy from other CLDN18.2 therapies that require high levels of CLDN18.2 expression, the enrollment of a new cohort in patients with low CLDN18.2 expression (≥1+ IHC staining intensity in <75% of tumor cells) was initiated in October 2025. 71 Table of Contents Since the label of checkpoint inhibitors in 1L GEC (including nivolumab) was limited to PD-L1 CPS≥1 by the FDA in June 2025, the standard of care of “double-low”, (i.e. low CLDN18.2 and low PD-L1 (CPS=0) expression), patients is chemotherapy only. Therefore, a potential accelerated approval pathway for the double-low patient population may exist, if givastomig is shown to add to the benefit of chemotherapy. The enrollment of the double-low cohort of combining givastomig with chemotherapy was initiated in November 2025. Additional cohorts of patients with 1L BTC and PDAC were also added to further explore givastomig’s potential in combination with the current standard care in these CLDN18.2-positive GI malignancies. Enrollment is expected to start in the first half of 2026. The planned two dose expansion cohorts, each evaluating 20 patients irrespective of PD-L1 expression, with tumors that express CLDN18.2 at ≥1+ intensity in ≥1% of cells at 8 mg/kg and 12 mg/kg Q2W for a total of 40 patients were fully enrolled in August 2025. Positive combination dose expansion data have been released in January 2026. A global, open label, randomized-controlled phase 2 study of givastomig in combination with nivolumab and chemotherapy in patients with CLDN18.2 positive and PD-L1 positive metastatic gastric cancers was initiated in February 2026. After the initiation of this study, we engaged the FDA in discussions over possible paths for accelerated approval for givastomig in combination with immunochemotherapy. Pathways for accelerated approval and benchmarks for success were identified, and a Phase 3 study is being designed for endorsement by the FDA at a future date. In addition to the internal development of givastomig, an investigator initiated study of givastomig in combination with durvalumab and chemotherapy in neoadjuvant locally advanced GC will be initiated in the first half of 2026 by Dr. Kohei Shitara in Japan. Dr. Shitara is a world-class leading investigator in gastric cancers. This study will extend the benefit of adding givastomig to SoC immunochemotherapy in resectable disease, and will provide an opportunity to study the mechanism of action of this combination because biopsies will be analyzed before and after treatment. Competitive Landscape We believe givastomig, if approved, will primarily compete against other CLDN18.2 targeted molecules which include monoclonal antibodies, bispecific antibodies and antibody drug conjugates. VYLOY (zolbetuximab, marketed by Astellas) is the only approved therapy targeting CLDN18.2 to date. There are additional molecules undergoing clinical development including but not limited to: AstraZeneca (AZD0901 / CMG901), Transcenta (osemitamab), AskGene Pharma (ASKB589), Sino Biopharmaceuticals (LM-302) and Innovent (IBI-343, IBI-389) VIS-101 for Wet AMD Summary VIS-101 is a next generation highly differentiated VEGF-A × ANG-2 bispecific antibody in Phase 2 development for Wet AMD and other retinal diseases, including DME. VIS-101 demonstrated encouraging outcomes in both Phase 1b and Phase 2a studies for Wet AMD, showing fast, robust and sustained improvements in best-corrected visual acuity (“BCVA”) and central subfield thickness (“CST”). Approximately half of the patients who received a 6 mg dose treatment remained without additional treatment for six months or longer, underscoring the long-lasting effects of the therapy. The safety profile was favorable, with no dose-limiting toxicities, retinal vasculitis, or vascular occlusion reported. Most adverse events were mild or moderate and resolved, except for a single instance of uveitis. When compared to other VEGF inhibitors like Lucentis®, Eylea®, and Vabysmo®/Eylea HD®, VIS-101 delivers similar BCVA efficacy but may offer increased durability, potentially allowing for less frequent dosing. These findings reinforce VIS-101's potential best-in-class position as a leading therapy in efficacy, safety, and durability for Wet AMD. Disease Background Age-related macular degeneration (“AMD”) is a leading cause of irreversible blindness in the elderly, with its prevalence expected to rise significantly as the global population ages. By 2040, the number of AMD cases is projected to reach 288 million worldwide. The main risk factors for AMD include increasing age, smoking, family history, and ethnicity. AMD is classified according to disease progression, ranging from normal ageing changes to advanced stages, which may involve neovascular AMD or geographic atrophy. Clinically, AMD is further categorized into dry and wet types, with Wet AMD being the primary cause of vision loss. The development of Wet AMD is driven by pathological choroidal neovascularization (“CNV”) beneath the macula, leading to leakage, hemorrhage, fibrosis, and damage to the central retina. VEGF plays a crucial role in this process, and VEGF inhibitors have proven effective in treating Wet AMD. In the last few years the development of multi-specific antibodies have increased with these drugs targeting both VEGF and a second target such as ANG-2, IL-6, or complement inhibition. Diagnosis and classification of AMD rely on clinical ophthalmology examination and imaging techniques such as ocular coherence tomography, fluorescein angiography, color fundus photography, and occasionally Indocyanine Green Angiography. 72 Table of Contents For Wet AMD, global revenue for anti-VEGF ophthalmology drugs is projected to grow to greater than $20 billion by 2030. Figure: Evaluate Pharma and GlobalData VIS-101 Background VEGFs are the most important pathological factors common to various neovascular ocular diseases. ANG-2, as a significant novel target for neovascular ocular diseases, collaborates synergistically with VEGFs in the pathological mechanisms of related diseases, playing a crucial pathogenic role at all stages of pathological neovascularization. The ANG-2/Tie2 pathway participates in vascular remodeling and maturation and is directly associated with the recruitment of pro-inflammatory factors. Activation of the ANG-2/Tie2 pathway leads to dephosphorylation of downstream signals in vascular endothelial cells, disrupting intercellular junctions in mature vessels. This directly reduces vascular stability, increases permeability, and promotes rapid release of pro-inflammatory factors, further disrupting intraocular physiological homeostasis. Clinically, this manifests as persistent macular edema and neovascular proliferation. Animal models have confirmed that upregulated ANG-2 expression exacerbates disruption of blood-brain barrier stability. Pharmacological downregulation of ANG-2 and activation of the Tie2 signaling pathway reduces vascular permeability and reduces stroke size in animal models. Concurrently, ANG-2 expression is significantly elevated in the aqueous humor of Wet AMD patients, showing correlation with the severity of the Wet AMD. Based on this evidence, we think that simultaneous downregulation of intraocular VEGF-A and ANG-2 can more rapidly and effectively alleviate symptoms of neovascular ocular diseases, reduce pathological pro-inflammatory factors, preserve vision, and achieve sustained improvement in best-corrected visual acuity and central subfield thickness of the retina. VIS-101 is a recombinant fusion protein composed of a humanized anti-VEGF monoclonal antibody and two ANG-2 inhibitory peptides. Therefore, VIS-101 has two VEGF-A binding sites and two ANG-2 binding sites per molecule (see chart below). Owing to the higher binding affinity for each VEGF and ANG-2 binding site and its tetravalent structure, this molecule exhibits high affinity binding and high inhibitory activity based on two binding sites per molecule to both VEGF-A and ANG-2 as compared to Vabysmo® (faricimab-svoa), an approved bispecific antibody targeting the same two factors but having one binding site for each per molecule. 73 Table of Contents Figure: Common anti-VEGF therapies approved today on the left and comparison of VIS-101 to faricimab. Nonclinical studies have demonstrated that VIS-101 possesses several advantages: optimized antigen alignment prevents mutual interference; VEGF-A affinity matches or exceeds marketed products (conbercept, aflibercept, ranibizumab); Compared with a faricimab analog, VIS-101 has greater than 2-fold and 6-fold higher binding activity to VEGF-A165 and ANG-2, respectively, plus 2.4-fold stronger VEGF-A165 inhibitory activity (cell-based reporter assay) and 16.7-fold stronger in ANG-2-Tie-2 inhibition (ELISA); Fc fragment modification that avoids neonatal fragment crystallizable (Fc) receptor (FcRn) antibody recycling increases systemic clearance and reduces exposure time and systemic VIS-101 levels, potentially lowering systemic toxicity risks. Figure: Binding activity and blocking activity of VIS-101 compared to a faricimab analogue and other anti-VEGF165 therapies. These favorable in vitro pharmacological properties translate into robust in vivo efficacy as demonstrated in a non-human primate laser-induced CNV model. In the rhesus monkeys with laser-induced CNV, a single intravitreal injection in each eye of VIS-101 (1.2 mg and 6 mg) significantly inhibited fundus angiogenesis and leakage compared to the control group in both eyes. Nonclinical Toxicology Nonclinical toxicology studies of VIS-101 were conducted in rhesus monkeys and rabbits, chosen due to their physiological similarity to humans and comparable high-affinity binding of VIS-101 to VEGF-A and ANG-2. Safety assessments included tissue cross-reactivity, hemolysis assays, single and repeat-dose intravitreal studies, and pivotal long-term toxicology evaluations. VIS-101 showed no off-target binding or hemolytic effects and was well-tolerated in both species, with no test article-related adverse findings at doses up to 3.0 mg/eye. Higher doses (up to 6.0 mg/eye) resulted in transient and mild ocular inflammation in isolated cases, attributed to immunogenic responses to the humanized antibody rather than direct toxicity. Long-term (26-week) studies in monkeys revealed minimal to mild sporadic intraocular inflammation, which was reversible and correlated with anti-drug antibody (“ADA”) titers, lacking dose-dependency and considered consistent with ADA induced inflammation. No significant abnormalities were observed in general health, clinical parameters, or organ pathology across all dose groups in all studies. Systemic toxicity was not detected even at high intravenous doses. Importantly, ADA-related immunogenicity in nonhuman primates is expected to be higher than in humans and thus does not predict clinical risk. Overall, VIS-101 is considered well-tolerated in animal doses up to 4.5 mg/eye and support the proposed clinical dose of up to 9.0 mg administered once monthly via intravitreal injection. The only notable adverse effect was immune-mediated (i.e., ADA) ocular inflammation, which was non-dose-limiting and not predictive of human response. These findings support the safety of VIS-101 for clinical trials and support the intended Phase 2b doses and clinical dosing regimen. Clinical Development 74 Table of Contents Early-phase clinical trials of VIS-101 were conducted in both China and the U.S. to assess safety, tolerability, and preliminary efficacy in single and multiple dosing regimens. In Phase I trials (China: ASKG712-CT-I-1, U.S.: AM712E1001), VIS-101 was well tolerated up to 6.0 mg and 9.0 mg, respectively, with improvements in visual function and anatomical outcomes, demonstrating favorable safety and promising durability of response with approximately half of participants retreatment-free at six months (see below). In the China Phase 1b and U.S. Phase 1b trial doses up to 6.0 mg were assessed using the low concentration formulation. The fast, robust and sustained visual acuity gains in the China Phase 1b are presented in the first figure below. In the U.S. Phase 1b study assessed doses up to 9.0 mg with the high concentration formulation to deliver 9.0 mg with 90 µL. The improvements in BCVA and CST from this U.S. trial are presented in the second figure below. These sustained gains in visual acuity and CST translate into a favorable durability profile presented in the third figure below. This is the first time that a VEGF therapy has demonstrated 24 weeks (six months) durability in over half of the participants. Figure: China Phase 1b: gains in BCVA over time to end of study in part 2 assessing the 3.0 mg and 6.0 mg doses. Figure: U.S. Phase 1: gains in BCVA and reduction in central retinal thickness in part 2 with up to 9.0 mg dose. 75 Table of Contents Figure: U.S. Phase 1: VIS-101 has a favorable durability profile in this small trial with over half of participants retreatment-free for 24 weeks (six months) after the loading dose. Following the China Phase 1 portion of the trial, the Phase 2a portion (part 3) evaluated 3.0 mg and 6.0 mg doses, confirming a favorable safety profile and rapid, robust and sustained improvements in BCVA and CST. This study enrolled 38 participants randomized 2:1 to the 3.0 mg dose (n=13) and the 6.0 mg dose (n=25). All participants received three loading doses at 0, 4 and 8 weeks and then were followed to assess the time to next treatment based on prespecified set of Disease Activity Criteria (based on change at each visit in BCVA or CST or fluid status or macular hemorrhage judged to be due to Wet AMD be the Investigator). Mean change from baseline in BCVA in treatment-naïve participants rapidly improved to 10 or more letters gained and this gain was sustained in approximately half of retreatment-free participants to 36 weeks (over six months after the last loading dose at week 8) when the study follow-up ended. The percent maintaining vision gains and remaining treatment free after three loading doses is presented in the upper bar graph below with approximately two-thirds remaining treatment free at 16 weeks (four months) and approximately half remaining treatment free at week 24 (six months). Similar improvements were observed in the mean change from baseline in CST in treatment-naïve participants with a rapid decrease in central retinal thickness that was sustained with approximately half of participants remaining retreatment-free at 36 weeks (over six months after the last loading dose at week 8) when the study follow-up ended. The percent maintaining this CST reduction and remaining treatment free after three loading doses is presented in the lower bar graph below with approximately two-thirds remaining treatment free at 16 weeks (four months) and approximately half remaining treatment free at week 24 (six months). The sustained BCVA gains and CST reductions discussed above demonstrate the durability of VIS-101 and the potential for a less frequent dosing schedule. The retreatment-free rate for the 3.0 mg and 6.0 mg VIS-101 doses are presented in the third figure below. Both doses show good durability to week 24 when the 3.0 mg durability begins to reduce and the 6.0 mg persists with approximately half of participants remaining retreatment free at 36 weeks (greater than six months after the last loading dose at week 8). 76 Table of Contents Figure: Fast, robust and sustained improvement in BCVA and CST. Figure: China Phase 2a: durability of the 6.0 mg and 3.0 mg dose groups as demonstrated by the retreatment-free rate. An exploratory Phase 2b, multicenter, randomized, quadruple-masked, active-controlled trial in China is planned for treatment-naïve Wet AMD participants. Up to 244 subjects will be randomized 1:1:1:1 across four arms (VIS-101 9.0 mg high concentration, VIS-101 6.0 mg high concentration, VIS-101 6.0 mg low concentration, and aflibercept 2.0 mg). The objective of the Phase 2b study are to assess the safety and efficacy of VIS-101 and to select the final dose for the Phase3 program. The study involves an initial loading phase, a treatment phase with individualized fixed-dose treatment regimens for VIS-101 based on disease activity, and standard aflibercept dosing (2.0mg every eight weeks) for the control arm. We expect to initiate the Phase 2b clinical trial in Q3 2026. Interim safety and pharmacokinetic reviews will guide treatment arm selection with possible discontinuation of the low concentration VIS-101 6.0 mg arm based on establishing safety in the high concentration arms (6.0 mg and 9.0 mg). All participants continuing after review will be followed through 52 weeks for primary and secondary analyses. The Phase 3 dose will be selected after a second unmasked review of efficacy and safety data during the trial and this will allow earlier EOP2 regulatory agency meetings and an accelerated start to the Phase 3 program. Phase 3 planning will involve regulatory alignment with agencies in China, the US, and the EMA with randomized, controlled trials (“RCT”) powered for non-inferiority to aflibercept. Based on RA alignment these trials will include either parallel group comparisons or individualized fixed-dose treatment regimens similar to the Phase 2b trial discussed above. The base plan is one RCT in the China/Asia pacific region and an additional global RCT (U.S., E.U., other regions) to support broader global regulatory submissions. Regulatory meetings to obtain RA feedback on the potential to perform one large global MRCT (U.S., E.U., China, other regions) with additional confirmatory evidence (including the Phase 2b trial discussed above and supportive data from faricimab publications which have a similar mechanism of action to VIS-101) will also be pursued in 2026. Competitive Landscape 77 Table of Contents The treatment landscape for retinal vascular diseases such as Wet AMD, DME, and RVO is highly competitive and dominated by two established VEGF-targeting therapies, specifically aflibercept (Eylea® and Eylea HD®), an engineered anti-VEGF receptor fusion protein, and faricimab (Vabysmo®), the first approved VEGF-A x ANG-2 bispecific antibody. As VIS-101 aims to become best-in-class VEGF x ANG-2 therapy, faricimab likely represents the most direct competitive benchmark for VIS-101. In addition to aflibercept and faricimab, additional molecules are currently undergoing clinical development and, if they are approved, may become competitors of VIS-101 as well. These include but are not limited to: new anti-VEGF therapies, other anti-VEGF x ANG-2, and combination of anti-VEGF with other targeted therapies, which may include approved therapies containing anti-VEGF agents or small molecule TKIs. Clinical-stage assets targeting these mechanisms include VEGF x ANG-2 bispecific and multi-specific antibodies: Ollin Biosciences/Innovent (OLN324/IBI324), China Medical System/Wuhan YZY (Y400), Abpro (ABP-201, IND-enabling), and Eluminex Biosciences (EB-105, trispecific with IL-6). VEGF/Tie-2 bispecific antibodies include Merck (EYE201/MK-8748) and Ingenia Therapeutics (IGT-427). There are also a number of clinical-stage VEGF bispecifics and multi-specifics targeting novel pathways: Innovent (IBI302, VEGF/Complement), Kodiak Sciences (KSI-501, VEGF/IL-6), RemeGen (RC28-E, VEGF/FGF), and EyeBio/Merck (EYE103/Restoret, FZD4/LRP1/TM4SF trispecific). Another class of therapies are sustained release/implants which includes Susvimo (Roche, ranibizumab) and small molecule TKIs with sustained delivery including EyePoint Pharmaceuticals (vorolanib/EYP-1901) and Ocular Therapeutix (AXPAXLI), to name a few. AAV-based therapies expressing VEGF receptor decoys have also shown promising results in late-stage clinical development, including Adverum/Lilly (Lxo-vec), 4D Molecular Therapeutics (4D-150), and RegenexBio/AbbVie (ABBV-RGX-314). As the global anti-VEGF ophthalmology drug market is projected to exceed $20 billion by 2030, the competitive dynamics of this market are expected to intensify as more bispecific and next-generation therapies emerge. Ragistomig (TJ-L14B): A PD-L1-Based Tumor-Dependent T-Cell Engager for Solid Tumors Summary Ragistomig, (also known as “ABL503” or “TJ-L14B”), is a bispecific antibody targeting both PD-L1 and 4-1BB that was developed in collaboration with ABL Bio. It was designed to improve the efficacy of anti-PD-(L)1 therapies while mitigating the potential toxicity associated with earlier 4-1BB-directed therapies. Similar to givastomig, 4-1BB-stimulated T cell activity only occurs upon tumor cell binding by the anti-PD-L1 part of ragistomig. This localized T cell activation has the potential to exert strong anti-tumor activity while reducing systemic side effects such as liver toxicity. In a humanized mouse tumor model, a short course of ragistomig treatment displayed greater anti-tumor efficacy than anti-PD-L1 or anti-4-1BB antibodies alone or in combination and showed evidence of immunological memory response that resisted tumor re-challenge. Ragistomig is being jointly developed through a global partnership with ABL Bio, in which ABL Bio acts as the lead party and we share worldwide rights (50/50), excluding Greater China and South Korea, equally with ABL Bio. Therapeutic Indications New therapeutic options are urgently needed for cancers that are refractory to or relapse after PD-(L)1 treatment because most patients treated with CPI do not achieve long-term survival. The approach of ragistomig is to maximize T cell activity by simultaneously blocking the inhibitory pathways via PD-L1 binding and turning on co-stimulatory 4-1BB pathway. Advantages of Ragistomig We believe that based on publicly available information and preclinical studies, ragistomig has the potential to be a highly differentiated PD-L1 and 4-1BB bispecific antibody. In terms of format, some of the leading compounds being researched to improve the efficacy of anti-PD-(L)1 therapies are monovalent heterodimers which may affect the potency of each arm and increase the complexity of chemistry, manufacturing and controls. In addition, as detailed earlier, the anti-4-1BB moiety of ragistomig binds to a novel epitope that only triggers 4-1BB signaling upon tumor binding leading to a reduced cytokine release and hepatic and systemic immunotoxicity without compromising anti-tumor activity. Ragistomig is also more specific than certain competitor molecules in terms of 4-1BB binding relative to other tumor necrosis factor (“TNR”) receptor families of co-stimulatory molecules. If proven in clinical trials, these potential advantages could differentiate ragistomig from other competing compounds. 78 Table of Contents Summary of Preclinical Results The ability of ragistomig to ligate 4-1BB and activate downstream signaling was tested in a co-culture of PD-L1-positive target cells with T cells as effectors (shown below). The results show that the level of NF-kB reporter activity elicited by ragistomig correlated with the level of PD-L1 expression on the target cells. In contrast, urelumab induced NF-kB reporter activity regardless of target cell PD-L1 expression. Importantly, ragistomig promoted the proliferation of CD8-positive tumor-infiltrating lymphocytes obtained from human tumor samples to a similar extent as urelumab, while the parental anti-PD-L1 and anti-4-1BB antibodies, either alone or in combination, had no effect, confirming a strict PD-L1-dependence on T cell stimulation by ragistomig. Figure: Dose-dependent PD-L1-restricted T cell activity by ragistomig but not urelumab in a co-culture system of T cells and target cells expressing different levels of PD-L1 (as represented by mean fluorescent intensity (MFJ) values). 79 Table of Contents In mice grafted with tumor cells expressing human PD-L1, ragistomig treatment every three days for four cycles suppressed tumor cell growth in a dose-dependent manner, delivering far better efficacy than equimolar doses of single agents alone or in combination. When the treated tumor-free mice were re-challenged with a second tumor graft after drug cessation, they remained resistant, indicating that ragistomig produced a durable anti-tumor response. Figure: Potent in vivo anti-tumor activity of ragistomig in a mouse tumor model. Mice transgenic for humanized 4-1BB were grafted with MC38 cells expressing human PD-L1. Mice were treated with the indicated antibodies every three days for four cycles. Tumor-free animals were re-challenged with a second dose of the tumor on day 40 with treatment-naïve animals as a control. Preclinical Safety In contrast to certain competitor PD-L1 x 4-1BB bispecific antibodies, ragistomig did not induce cytokine release (including IL-6 and TNF-α) up to 0.83 mg/ml, which corresponded to a human equivalent dose of 15 mg/kg. Animal pharmacokinetic and toxicity studies have also been completed. Results of these studies indicate that the NOAEL was 15 mg/kg/dose. This dose was also considered the highest non-severely toxic dose. A starting dose of 0.7 mg was proposed for the first-in-human study. There is a greater than 3000-fold safety margin between the proposed first-in-human dose and the nonclinical safety assessment studies including in vitro cytokine release assays and good laboratory practice toxicology studies. Summary of Clinical Results In June 2024, our development partner, ABL Bio, presented promising objective responses in patients with various advanced solid tumors that are refractory or have relapsed after PD-(L)1 inhibitors from the Phase 1 dose escalation study at ASCO 2024. Of the 53 enrolled patients, 44 were efficacy evaluable patients with advanced or relapsed/refractory solid tumor. 64.2% (34/53) of enrolled patients had at least three prior lines of therapies. Top-line Phase 1 dose escalation and dose expansion results demonstrated an ORR of 26.9% (7/26), including six partial responses and one complete response, and a clinical benefit rate of 69.2% (18/26) at doses of 3 mg/kg and 5 mg/kg. 71.4% of responders received prior treatment with anti-PD-(L)1 inhibitors. To further increase the therapeutic index of ragistomig, two cohorts were added to the Phase 1 study in order test whether increased spacing of doses from Q2W to Q6W would maintain efficacy and decrease toxicity. In December 2025, ABL presented positive Phase 1 dose expansion data of ragistomig 3 mg/kg Q6W at ESMO IO. These data showed comparable anti-tumor efficacy for the 3 mg/kg Q6W dose schedule compared to the 3 mg/kg Q2W regimen (58.8% DCR at Q6W compared to 64.3% at Q2W). Ragistomig exhibited a favorable and improved safety profile, with 1/20 Grade 3 or greater liver function test elevations, no treatment discontinuations due to treatment emergent adverse events and no reported cytokine release syndrome. Overall immune cell activity was consistent between the Q6W and Q2W dosing. Immune cell pharmacodynamics with the Q’6W dosing demonstrated expansion of effector memory and CD8-positive T cells, with attenuated Treg expansion, indicating durable immune engagement. The data highlight the completion of the ongoing 5 mg/kg Q6W dosing cohort and planned evaluation of ragistomig in future combination studies. Clinical Development Plan Our partner ABL Bio is conducting a Phase 1b study to evaluate the safety and efficacy of 3 mg/kg and 5 mg/kg Q6W ragistomig. Once the monotherapy dose determined, the plan is to explore the combination therapy in appropriate tumor types for further development. 80 Table of Contents Competitive Landscape We believe ragistomig, if approved, will primarily compete against other PD-L1 x 4-1BB bispecific antibodies and secondarily against therapeutic immunotherapy options designed for cancers that are refractory to have relapsed after PD-(L)1 treatment. There are currently no approved or marketed therapies utilizing the PD-L1 x 4-1BB pathway. However, there are competing molecules within the class currently undergoing clinical development. Of note, Genmab, the sponsor of acasunlimab, has terminated development of this asset due to business and strategic decisions. Uliledlimab (TJD5): A Highly Differentiated CD73 Antibody for Solid Tumors Summary Uliledlimab is a CD73 neutralizing antibody that targets a critical enzymatic step in the generation of adenosine. CD73 is a homodimeric enzyme widely expressed in multiple tumors and converts extracellular adenosine monophosphate (“AMP”) to adenosine, which contributes to an immuno-suppressive tumor microenvironment. A key differentiating feature of uliledlimab, when compared to some of the other clinical-stage CD73 antibodies, is related to its novel epitope, which works through a unique intra-dimer binding mode, resulting in complete inhibition of the enzymatic activity and avoiding the aberrant pharmacological property known as the “hook effect.” In addition, uliledlimab has a non-competitive inhibitory effect that is not blunted by high levels of CD73 enzyme substrates, which may be observed in small-molecule competitive blockers. Preclinical studies have shown that uliledlimab can completely reverse the adenosine-mediated suppression of T cells in vitro. When combined with a PD-(L)1 antibody in vivo, uliledlimab exhibited a superior and synergistic inhibitory effect on tumor growth compared to PD-(L)1 monotherapy. Figure: Differentiation of uliledlimab from other CD73 inhibitors. A key differentiating feature of the clinical development of uliledlimab is that we are testing the hypothesis that patients whose tumors express higher levels of CD-73 (and thereby have higher levels of adenosine) are more likely to respond to uliledlimab. In the U.S., we have completed the initial assessment of a Phase 1 clinical trial where uliledlimab was evaluated as a monotherapy lead-in and followed by combining it with atezolizumab (Tecentriq®) in patients with solid tumors. Topline results from this trial showed that uliledlimab was well-tolerated across all the dose cohorts evaluated. The data demonstrated a favorable linear pharmacokinetic and steep pharmacokinetic/pharmacodynamic relationship with complete receptor occupancy as expected based upon the normal dose-response property of uliledlimab without the hook effect. Furthermore, positive clinical efficacy signals from this trial were observed in non-small cell lung cancer and ovarian cancer patients with higher levels of CD73 and PD-L1 co-expression in the tumor, indicating a potential correlation between the clinical activity of uliledlimab and tumor CD73 expression as a potential predictive biomarker that warrants further investigation. 81 Table of Contents Supported by the results of the Phase 1 trial, Phase 2 trials are further evaluating the efficacy and safety of uliledlimab in combination with checkpoint inhibitors in Stage IV NSCLC and other select tumor types. The Phase 2 cohort data of uliledlimab in combination with toripalimab (TUOYI®), a programmed cell death protein (PD-1) inhibitor, in patients with Stage IV NSCLC were presented in June 2023 at the 2023 ASCO annual meeting. Results from an ongoing Phase 2 trial of uliledlimab in combination with toripalimab showed a favorable safety profile and an objective response rate of 63% (10/16) in patients whose tumors expressed higher levels of CD73 and had a PD-L1 tumor proportion score of >1%. In the overall population regardless of CD73 and PD-L1 expression, the ORR was 31% (21/67). Molecular Differentiation of Uliledlimab Extracellular AMP can be generated from adenosine triphosphate, cyclic AMP, and nicotinamide adenine dinucleotide through separate biochemical pathways, all of which converge to CD73 as a rate-limiting enzyme to generate adenosine. Thus, the CD73 antibody may block adenosine generation more completely than other upstream targets in the adenosine pathway. The key advantages of uliledlimab when compared with other CD73 antibodies or small molecule inhibitors can be summarized as follows: (1) uliledlimab exhibits a typical dose-response curve without the “hook effect” to achieve the complete inhibition of both soluble and surface-bound CD73; and (2) uliledlimab has a non-competitive inhibitory effect that is not blunted by high levels of CD73 enzyme substrates such as AMP, which may occur with small-molecule competitive blockers that target the AMP binding site on CD73. These pharmacological properties may translate into efficient target inhibition in tumors and superior anti-tumor activity, especially in an adenosine-rich micro-environment. Biochemically, uliledlimab displayed complete inhibition of soluble CD73 enzymatic activity (IC50 = 0.22 n M) without the “hook effect” in contrast to the comparator molecules, which at higher concentrations caused a paradoxical rebound of enzymatic activity presumably due to its inter-dimer binding mode. The recent structural data revealed by cryo-EM showed that uliledlimab binds to a unique epitope located at the C-terminus of CD73 dimer distinct from other CD73 antibodies, including oleclumab, all of which bind to the N-terminus of CD73. With this unique epitope, uliledlimab adopts a differentiated intra-dimer binding mode to prevent the conformational change of CD73 from inactive to the active form, resulting in the complete inhibition of CD73 enzymatic activity without causing a “hook effect.” Figure: Inhibition of soluble CD73 enzymatic activity and the binding epitope of CD73 antibodies. In preclinical studies, AMP inhibits interferon-gamma (“IFN-γ”) production by CD4 or CD8 T cells through adenosine generation, mimicking the suppressive tumor micro-environment where AMP is abundantly produced. However, this suppression can be reversed by uliledlimab in a concentration-dependent manner. Moreover, in an experimental system where CD73 high human ovarian cell line SK-OV-3 and human T cells were co-cultured, the addition of uliledlimab restored T cell activity as measured by IFN-γ production in a concentration-dependent manner. In addition to the reversal of AMP-mediated T cell suppression, uliledlimab treatment activates human B cells, as evidenced by the up-regulation of activation markers CD69 and CD83, as well as antigen presentation markers CD86 and HLA-DR. Compared with T cells, the effects of uliledlimab on B cells were adenosine independent. 82 Table of Contents Consistent with the in vitro results, in vivo monotherapy of uliledlimab dose-dependently inhibited in situ tumor-derived CD73 activity, leading to the anti-tumor effect in a mouse xenograft model bearing A375 melanoma cells, while such dose-dependency was not observed by oleclumab. Figure: Inhibitions of CD73 activity and tumor growth by uliledlimab and oleclumab. To examine whether uliledlimab could enhance the anti-tumor activity of PD-1 or PD-L1 antibodies, we evaluated the therapeutic effects of uliledlimab in combination with a PD-1 antibody in the MC38 model using CD73 humanized mouse and a PD-L1 antibody in the A375 xenograft model, respectively. The combination treatments resulted in more potent inhibition of tumor growth than monotherapy with either the PD-(L)1 antibody or uliledlimab. Figure: Inhibition of tumor growth and in situ CD73 activity by uliledlimab alone or in combination with a PD-1 or PD-L1 antibody. 83 Table of Contents Summary of Clinical Results Phase 2 clinical trial of uliledlimab in combination with PD-1 antibody (toripalimab) in advanced NSCLC In June 2023, the clinical results of Phase 1b/2 study (NCT04322006) evaluating uliledlimab in combination with toripalimab (TUOYI®) in patients with NSCLC were presented at the 2023 ASCO annual meeting. The data are part of a dose expansion portion of a Phase 1b/2 trial evaluating the safety and efficacy of the combination therapy and investigating the potential correlation between tumor CD73 expression and clinical response for patients with advanced cancer. As of April 14, 2023, 70 patients had been enrolled in the Phase 1b/2 cohort of uliledlimab and PD-1 combination therapy for patients with Stage IV NSCLC who were ineligible for or refused chemotherapy. Early results from an ongoing Phase 2 trial of uliledlimab in combination with toripalimab, a PD-1 inhibitor, showed a favorable safety profile and an objective response rate of 63% (10/16) in patients whose tumors expressed higher levels of CD73 and had a PD-L1 tumor proportion score of >1%. In the overall population regardless of CD73 and PD-L1 expression, the ORR was 31% (21/67). To confirm this data, a randomized study is underway by our collaborator, TJ Biopharma in China, which will test the combination of uliledlimab in combination with toripalimab vs. monotherapy toripalimab vs. monotherapy pembrolizumab, all in a CD73 high selected first-line, mNSCLC population. This study will directly support the hypothesis that CD73 expression will predict response to uliledlimab and provide insight into the magnitude of benefit when uliledlimab is added to a checkpoint inhibitor. Figure: Phase 2 data of uliledlimab combined with toripalimab in treatment-naïve NSCLC patients. Clinical Development Plan Following the divestiture of our Greater China assets and business operations, we are pausing the development of uliledlimab to allow for further data from the ongoing randomized Phase 2 data in China, and to allocate resources to advance our lead clinical asset, givastomig. We will continue to monitor data from the ongoing China-only randomized study conducted by TJ Biopharma. Phase 2 progression free survival (“PFS”) data from this trial is expected to be presented by TJ Biopharma in 2026. Competitive Landscape We believe uliledlimab, if approved, would potentially compete with other CD73 antibodies in development. The most advanced CD73 antibody currently in clinical development is oleclumab (MEDI-9447) sponsored by AstraZeneca, which has initiated a Phase 3, double-blinded, placebo-controlled, randomized trial of durvalumab plus oleclumab in patients with locally advanced (Stage III), unresectable NSCLC who have not progressed following definitive, platinum-based concurrent chemoradiation therapy (PACIFIC 9). Arcus Biosciences has also reported results in their Phase 1b/2 trial of quemliclustat, a small molecule CD73 inhibitor, in combination with zimberelimab plus chemotherapy in patients with treatment naïve pancreatic cancer. Drebuxelimab, also known as AK119 (from 84 Table of Contents AkesoBio) is in a Phase 1b/2 study in combination with ivonescimab, a PD-1/VEGF bispecific, for the treatment of advanced solid tumors. Licensing and Collaboration Arrangements A. Licensing Arrangements On October 14, 2025, in connection with the Series A Subscription Agreement, we, through Visara, entered into an assignment and assumption agreement with AffaMed pursuant to which AffaMed assigned certain rights to develop, commercialize and otherwise exploit VIS-101 to Visara in countries worldwide except for Singapore, Thailand, Malaysia, Indonesia, Vietnam, the People’s Republic of China, Taiwan, Macau, Hong Kong, Korea and India under the existing exclusive license agreement dated November 6, 2021 between AffaMed and AskGene. As consideration for the assignment, Visara paid $5.0 million in cash and issued 16,150,000 shares of its Series A preferred stock pursuant to the Series A Subscription Agreement to AffaMed. AffaMed is an affiliate of CBC Group, one of our principal shareholders. See Note 17 – Related Party Balances and Transactions for details regarding our related party relationship and transactions. On October 15, 2025, we, through Visara, entered into an licensing agreement with AskGene for an exclusive royalty-bearing license to develop VIS-101 in Singapore, Thailand, Malaysia, Indonesia, Vietnam, the People’s Republic of China, Taiwan, Macau, Hong Kong, Korea, and India (the “Asian Territories”) for an upfront payment in the amount of $7.0 million and reimbursement of certain costs incurred in connection with AskGene’s ongoing Phase 2a study and long-term toxicology study of VIS-101 up to an aggregate amount of RMB 24 million. On October 28, 2025, Visara assigned its rights in the Asian Territories to Everest for an upfront payment in the amount $7.0 million and assumption of all payment obligations under the license agreement between Visara and AskGene. For the year ended December 31, 2025, there was no impact to our consolidated statements of comprehensive loss resulting from the aforementioned transactions because the assignment of the license to Everest was contemplated as part of the overall transaction structure at the time the October 15, 2025 AskGene exclusive license agreement was executed. Everest, an affiliate of CBC Group, and CBC Group are two of our principal shareholders. See Note 17 – Related Party Balances and Transactions for details regarding our related party relationship and transactions. B. Collaboration Arrangements In July 2018, we entered into a collaboration agreement with ABL Bio (as amended, the “ABL Bio Collaboration Agreement”), which has been subsequently amended, whereby both parties agreed to collaborate to develop two bispecific antibodies by using ABL Bio’s proprietary BsAb technology and commercialize them in their respective territories, which, collectively, include Greater China, South Korea and other territories throughout the rest of the world if both parties agree to do so in such other territories during the performance of the ABL Bio Collaboration Agreement. The ABL Bio Collaboration Agreement may be terminated by either party for the other party’s uncured material breach or in the event that the other party challenges its patents. Also, if a party encounters insurmountable technical difficulties and risks which cannot be resolved by such party within a certain period thereafter despite all reasonable efforts, such party will have the right to terminate the agreement and will no longer have the right to develop the licensed product. Following the divestiture of our Greater China assets and business operations and as of the date of this annual report, our rights in the ABL Bio Collaboration Agreement are limited to a 50/50 split for worldwide rights excluding Greater China and South Korea. In November 2018, we entered into collaboration agreements with Tracon, whereby we and Tracon agreed to (i) co-develop our proprietary CD73 antibody, TJD5, and (ii) collaborate to co-develop up to five bispecific antibodies (together, the “Tracon Collaboration Agreements”). Both agreements may be terminated by either party for the other party’s uncured material breach, bankruptcy or insolvency or for other reasons. In April 2020, Tracon issued a notice of disputes with respect to the Tracon Collaboration Agreements. In February 2021, we sent Tracon a notice to terminate the agreement we entered into with Tracon to co-develop TJD5, which would result in a prespecified termination fee of $9.0 million owing to Tracon. The disputes were presented to a binding arbitration proceeding under the Rules of Arbitration of the International Chamber of Commerce before an arbitration tribunal. On April 25, 2023, the arbitration award determined that the agreement in relation to TJD5 has been terminated for a pre-agreed termination fee of $9.0 million plus interest payable pursuant to the original agreement, and therefore Tracon has no rights to share any future economics with us. In July 2023, the pre-agreed termination fee in relation to TJD5 and an agreed-upon portion of Tracon’s legal fees and costs to Tracon were paid by NovaBridge. The remainder of the Tracon Collaboration Agreements were subsequently terminated and the financial impacts of the transaction were allocated to discontinued operations for the periods presented. In June 2024, we entered into a clinical trial collaboration and supply agreement (the “BMS Collaboration Agreement”) with Bristol-Myers Squibb Company (“BMS”) to evaluate our novel bispecific antibody, givastomig, targeting Claudin18.2 x 4-1BB in clinical trials, in combination with BMS’s anti-PD-1 monoclonal antibody product known as OPDIVO® (nivolumab). Under the terms of the BMS Collaboration Agreement, we will be responsible for sponsoring and conducting, at our own cost, a multi-national Phase 1 trial of givastomig in combination with nivolumab. BMS will manufacture and supply a sufficient amount of nivolumab to us solely for the 85 Table of Contents conduct of the combination therapy at no charge to us. Under the BMS Collaboration Agreement, BMS grants to us a non-exclusive, non-transferable, fully-paid-up, royalty-free license worldwide, except for certain specified territory, to use nivolumab in research and development solely to the extent necessary to conduct the combination therapy, seek regulatory approval for, and upon such regulatory approval, market and promote givastomig for use in the combination therapy with nivolumab. We grant to BMS a non-exclusive, non-transferable, fully-paid-up, royalty-free license worldwide, except for certain specified territory, to seek regulatory approval for, and upon such regulatory approval, market and promote nivolumab in the combination therapy with givastomig. Competition Our industry is highly competitive and subject to rapid and significant change. While we believe that our management’s research and development experience provides us with competitive advantages, we face competition from global biopharmaceutical companies, including specialty pharmaceutical companies, generic drug companies, biologics drug companies, academic institutions, government agencies and research institutions. For our Global portfolio of drug candidates, we expect to face competition from a broad range of global and local pharmaceutical companies. Many of our competitors have significantly greater financial, technical and human resources than we have, and mergers and acquisitions in the biopharmaceutical industry may result in even more resources being concentrated among a smaller number of our competitors. Our commercial opportunity could be reduced or eliminated if our competitors develop or market products or other novel therapies that are more effective, safer or less costly than our current or future drug candidates or obtain regulatory approval for their products more rapidly than we may obtain approval for our drug candidates. Intellectual Property Our success will depend significantly on our ability to obtain and maintain patent and other proprietary protection for our drug candidates and other commercially important products, technologies, inventions and know-how, as well as on our ability to defend and enforce our patents including any patent that we have or may issue from our patent applications, preserve the confidentiality of our trade secrets and operate without infringing the valid and enforceable patents and proprietary rights of other parties. As of March 24, 2026 our owned, co-owned or controlled patent portfolio consists of (i) 83 issued patents, including nine issued in the United States, 74 issued in other jurisdictions; and (ii) 72 pending patent applications, including three pending PCT patent applications, 15 pending U.S. patent applications, and 54 patent applications in other jurisdictions. Our owned, co-owned or controlled patents and patent applications primarily relate to the drug candidates in our Global portfolio, including VIS-101 after the Series A financing of Visara. •Givastomig - As of March 24, 2026, we co-owned four PCT patent applications with ABL Bio, two of which have entered national phases including in Europe, the United States, and additional jurisdictions and eight provisional patent applications. We expect that any patent that may issue under these applications will expire between 2040 and 2047, before taking into account any extension that may be obtained through patent term extension or adjustment, or term reduction due to filing of terminal disclaimers. •VIS-101 - As of March 24, 2026, we co-owned one PCT application with AskGene Pharma, Inc., and controlled four U.S. patents and 2 U.S. patent applications, two Chinese patents and two European patent applications. We expect that any patent that may issue under these applications will expire between 2040 and 2045, before taking into account any extension that may be obtained through patent term extension or adjustment, or term reduction due to filing of terminal disclaimers. •Uliledlimab - As of March 24, 2026, we owned three PCT patent applications, all of which have entered national phases including in Europe, the United States, and additional jurisdictions. We expect that any patent that may issue under these applications will expire between 2038 and 2043, before taking into account any extension that may be obtained through patent term extension or adjustment, or term reduction due to filing of terminal disclaimers. •Ragistomig - As of March 24, 2026, we co-owned two PCT patent applications with ABL Bio, both of which have entered national phases including Europe, the United States, and additional jurisdictions. We expect that any patent that may issue under these applications will expire between 2039 and 2044, before taking into account any extension that may be obtained through patent term extension or adjustment, or term reduction due to filing of terminal disclaimers. The term of a patent depends upon the laws of the country in which it is issued. In most jurisdictions, the patent term of a utility patent is 20 years from the earliest filing date of a non-provisional patent application. In addition to patents, we rely upon unpatented trade secrets and know-how and continuing technological innovation to develop and maintain our competitive position. However, trade secrets and know-how can be difficult to protect. We seek to protect our 86 Table of Contents proprietary information in part by executing confidentiality agreements with our partners, collaborators, scientific advisors, employees, consultants and other third parties, and invention assignment agreements with our consultants and employees. We have also executed agreements requiring assignment of inventions with selected scientific advisors and collaborators. The confidentiality agreements we enter into are designed to protect our proprietary information and the agreements or clauses requiring assignment of inventions to us are designed to grant us ownership of technologies that are developed through our relationship with the respective counterparty. We cannot guarantee that we have entered into such agreements with each party that may have or have had access to our trade secrets or proprietary technology and processes or that these agreements will afford us adequate protection of our intellectual property and proprietary information rights. If any of the partners, collaborators, scientific advisors, employees and consultants who are parties to these agreements breaches or violates the terms of any of these agreements or otherwise discloses our proprietary information, we may not have adequate remedies for any such breach or violation, and we could lose our trade secrets as a result. Additionally, as of March 24, 2026, in connection with our new name and the establishment of Visara, we filed trademark applications related to our new company names and logos, including four in the U.S., four in Europe, five in Hong Kong, and 10 in the PRC; and 15 domain names, including nine that are related to our new company name. For more information on these and other risks related to intellectual property, see “Item 3. Key Information—D. Risk Factors—Risks Related to Our Intellectual Property.” Environmental, Health and Safety Matters In August 2021, we established an environmental, social and governance (“ESG”) committee. The ESG committee consists of one independent director and one director, Mr. Chun Kwok Alan Au and Dr. Xi-Yong (Sean) Fu, respectively. Mr. Chun Kwok Alan Au chairs the committee. As the oversight body for our ESG practices, the ESG committee is responsible for supervising our ESG strategies, policies, long-term sustainability objectives and risks. We are required to comply with environmental laws and regulations applicable to our operations. With the current state of business operations, we believe we have no significant environmental impact due to no large-scale manufacturing operations. We also provide employee training and prepare standard operation procedures and contingency plans for potential environmental, health and safety incidents. Safety and health are the foundation of our operational activities. We created a comprehensive internal safety management system to ensure compliance, strengthen risk assessment and management. We offer standard operating procedures to ensure employees are aware of any potential hazards, including providing emergency training, treatment facilities, and personal protection equipment to all employees. Regulation We are subject to a variety of U.S. and PRC laws, rules and regulations affecting many aspects of our business. This section summarizes the principal laws and regulations in the United States and China that we believe are relevant to our business and operations. PRC Regulation We are subject to a variety of PRC laws, rules and regulations affecting many aspects of our business. This section summarizes the principal PRC laws, rules and regulations that we believe are relevant to our business and operations. Regulations on Company Establishment and Foreign Investment Company Law The establishment, operation and management of companies in China is governed by the PRC Company Law, the latest amended edition of which came into effect on July 1, 2024. In light of the PRC Company Law, companies established in the PRC are either in the form of a limited liability company or a joint stock company. The PRC Company Law applies to both PRC domestic companies and foreign-invested companies, unless otherwise provided in the foreign investment laws and regulations. Foreign Investment Law On March 15, 2019, the National People’s Congress approved the PRC Foreign Investment Law, which became effective on January 1, 2020. The Foreign Investment Law establishes the basic framework for the access to, and the promotion, protection and administration 87 Table of Contents of foreign investments in view of investment protection and fair competition. According to the Foreign Investment Law, “foreign investment” refers to investment activities directly or indirectly conducted by one or more natural persons, business entities, or other organizations of a foreign country (collectively referred to as “foreign investor”) within China, and “investment activities” include the following activities: (i) a foreign investor, individually or together with other investors, establishes a foreign-invested enterprise within China; (ii) a foreign investor acquires stock shares, equity shares, shares in assets, or other similar rights and interests of an enterprise within China; (iii) a foreign investor, individually or together with other investors, invests in a new construction project within China; and (iv) investments in other means as provided by the laws, administrative regulations or the State Council. Regulations Relating to Foreign Investment On December 26, 2019, the State Council promulgated the Implementation Rules to the Foreign Investment Law, which became effective on January 1, 2020. The implementation rules further clarified that the state encourages and promotes foreign investment, protects the lawful rights and interests of foreign investors, regulates foreign investment administration, continues to optimize foreign investment environment, and advances a higher-level opening. Furthermore, PRC-based investments by foreign investors are currently regulated by the Special Management Measures (Negative List) for the Access of Foreign Investment (2024) issued on September 6, 2024 and effective from November 1, 2024, and the Catalogue of Industries for Encouraging Foreign Investment (2025 Version) issued on December 15, 2025 and effective from February 1, 2026. According to the aforesaid catalogue and management measures, foreign-invested industries fall into four categories, namely, “encouraged”, “permitted”, “restricted” and “prohibited” and certain ownership requirements, requirements for senior executives and other special management measures should apply to foreign investors with regard to the access of foreign investments in certain categories. On December 30, 2019, the Ministry of Commerce and the State Administration for Market Regulation jointly promulgated Measures for Information Reporting on Foreign Investment, which became effective on January 1, 2020. Pursuant to the Measures for Information Reporting on Foreign Investment, where a foreign investor carries out investment activities in China directly or indirectly, the foreign investor or the foreign-invested enterprise should submit the investment information to the competent commerce department. M&A Rules According to the Provisions on the Merger or Acquisition of Domestic Enterprises by Foreign Investors jointly issued by the Ministry of Commerce, the State Assets Supervision and Administration Commission of the State Council, the State Administration of Taxation, the State Administration for Industry and Commerce (now known as the State Administration for Market Regulation), the China Securities Regulatory Commission and SAFE on August 8, 2006 and amended by the Ministry of Commerce on June 22, 2009, among other things, (i) the purchase of an equity interest or subscription that increases the registered capital of non-foreign-invested enterprises, (ii) the establishment of foreign-invested enterprises to purchase and operate the assets of non-foreign-invested enterprises, or (iii) the purchase of the assets of non-foreign-invested enterprises and the use of such assets to establish foreign-invested enterprises to operate such assets, in each case by foreign investors, is subject to the Provisions on the Merger or Acquisition of Domestic Enterprises by Foreign Investors. Particularly, application should be made for examination and approval of the acquisition of any company in China affiliated with a domestic company, enterprise or natural person, which is made in the name of an oversea company established or controlled by such domestic company, enterprise or natural person. PRC Drug Regulation The Drug Administration Law of the PRC promulgated by the Standing Committee of the National People’s Congress on September 20, 1984 and effective from July 1, 1985 and amended on February 28, 2001, December 28, 2013, April 24, 2015 and August 26, 2019, respectively, and the Implementing Measures of the Drug Administration Law promulgated by the State Council on August 4, 2002 and effective from September 15, 2002 and amended on February 6, 2016, March 2, 2019, December 6, 2024 and January 16, 2026, respectively, have jointly established the legal framework for the administration of pharmaceutical products in China, including the research, development and manufacturing of new drugs. The Drug Administration Law applies to entities and individuals engaged in the development, production, trade, application, supervision and administration of pharmaceutical products, which regulates and provides for a framework for the administration of pharmaceutical manufacturers, pharmaceutical trading companies and medicinal preparations of medical institutions, and the development, research, manufacturing, distribution, packaging, pricing and advertisements of pharmaceutical products. The Implementing Measures of the Drug Administration Law, on the other hand, provides detailed implementation regulations for the Drug Administration Law. The amendment to the Drug Administration Law in 2019 brought a series of changes to the drug supervision and administration system, including the clarification of the drug marketing authorization holder system, pursuant to which the marketing authorization holder should assume responsibilities for non-clinical studies, clinical trials, manufacturing and marketing, post-marketing studies, 88 Table of Contents monitoring, reporting and handling of adverse reactions of the drug. The amendment also stipulates that the State supports the innovation of drugs with clinical value and specific or special effects on human diseases, encourages the development of drugs with new therapeutic mechanisms and multi-targeted, systematic regulatory and intervention functions on the human body and promotes the technological advancement of drugs. Regulatory Authorities Pharmaceutical products and medical devices and equipment in China are monitored and supervised on a national scale by the National Medical Products Administration (the “NMPA”), while the local provincial medical products administrative authorities are responsible for the supervision and administration of drugs within their respective administrative regions. The NMPA is the chief drug regulatory agency and the NMPA regulates almost all of the key stages of the life cycle of pharmaceutical products, including non-clinical studies, clinical trials, marketing approvals, manufacturing, advertising and promotion, distribution, and pharmacovigilance (i.e., post-marketing safety reporting obligations). The Center for Drug Evaluation, which remains under the NMPA, conducts the technical evaluation of each drug and biologic application for safety and effectiveness. The National Health Commission is China’s chief healthcare regulator. It is primarily responsible for overseeing the operation of medical institutions, which also serve as clinical trial sites, and regulating the licensure of hospitals and medical personnel. The National Health Commission plays a significant role in drug reimbursement. Furthermore, the National Health Commission and its local counterparts at or below provincial-level local governments also oversee and organize public medical institutions’ centralized bidding and procurement process for pharmaceutical products, which is the chief means through which public hospitals and their internal pharmacies acquire drugs. Manufacturing and Distribution According to the Drug Administration Law, all facilities that manufacture drugs in China must receive a drug manufacturing license from the local drug regulatory authority. Each drug manufacturing license issued to a pharmaceutical manufacturing enterprise is effective for a period of five years. Similarly, for sales, importation, shipping and storage businesses, a company must obtain a distribution license from the local drug regulatory authority, subject to renewal every five years. China has implemented a “Two-Invoice System” to control the distribution of prescription drugs. The “Two-Invoice System” generally requires that no more than two invoices be issued throughout the distribution chain: one from the manufacturer to a distributor and another from the distributor to the end-user hospital. This excludes the sale of products invoiced from the manufacturer to its wholly-owned or controlled distributors, or for imported drugs, to its exclusive distributor, or from a distributor to its wholly-owned or controlled subsidiary (or between its wholly-owned or controlled subsidiaries). However, the system still significantly limits the options for companies to use multiple distributors to reach a larger geographic area in China. Compliance with the Two-Invoice System is a prerequisite for pharmaceutical companies to participate in the procurement processes of public hospitals, which currently provide most of China’s healthcare services. Manufacturers and distributors that fail to implement the Two-Invoice System may lose their qualifications to participate in the bidding process. Non-compliant manufacturers may also be blacklisted from engaging in drug sales to public hospitals in a locality. The Two-Invoice System was first implemented in 11 provinces involved in pilot comprehensive medical reforms, and the program has been expanded to nearly all provinces, each with its own individual rules for the program. New Drug Application Pursuant to the Administrative Measures for Drug Registration, upon completion of research and other preparation work, the applicant may apply to the NMPA for approval of a new drug application. The NMPA will then determine whether to approve the application according to the comprehensive evaluation opinion issued by the Center for Drug Evaluation of the NMPA. During the new drug application stage, depending on the characteristics of the drug and the corresponding conditions, applicants may apply for adoption of special procedures, including the Priority Review Procedure and the Special Review Procedure. Such procedures may be applied for innovative drugs for severe infectious diseases or rare diseases, breakthrough drugs and other eligible drugs stipulated in the Administrative Measures for Drug Registration. Extra policy support, including a shortened review period, may be given to applicants in such special procedures. 89 Table of Contents Marketing Authorization Holder System Pursuant to the Drug Administration Law, under the drug marketing authorization holder mechanism, an enterprise or a research and development institution that has obtained a drug registration certificate is eligible to be a drug marketing authorization holder. The drug marketing authorization holder should be responsible for nonclinical laboratory studies, clinical trials, production and distribution, post-market studies, and the monitoring, reporting, and handling of adverse reactions in connection with pharmaceuticals in accordance with the provisions of the Drug Administration Law. The drug marketing authorization holder may engage contract manufacturers for manufacturing, provided that the contract manufacturers are licensed and may engage pharmaceutical distribution enterprises with drug distribution license for sales, importation, shipping and storage businesses. Upon the approval of the medical products administrative department under the State Council, a drug marketing authorization holder may transfer the drug marketing license, and the transferee should have the capability of quality management, risk prevention and control, and liability compensation to ensure the safety, effectiveness and quality controllability of drugs, and fulfill the obligations of the drug marketing license holder. Intellectual Property Rights China became a member of the World Trade Organization and a party to the Agreement on Trade-Related Aspects of Intellectual Property Rights on December 11, 2001. China has also entered into several international conventions on intellectual property rights, including the Paris Convention for the Protection of Industrial Property, the Madrid Agreement Concerning the International Registration of Marks, and the Patent Cooperation Treaty. Patents Pursuant to the PRC Patent Law promulgated by the Standing Committee of the National People’s Congress on March 12, 1984,as amended on September 4, 1992, August 25, 2000, December 27, 2008 and October 17, 2020, the latest revision of which became effective on June 1, 2021, and the Implementation Rules of the Patent Law of the PRC promulgated by the State Council on June 15, 2001, as amended on December 28, 2002, January 9, 2010 and December 11, 2023, the latest revision of which became effective on January 20, 2024, patents in China fall into three categories: invention, utility model and design. An invention patent is granted to a new technical solution proposed in respect of a product or method or an improvement of a product or method. A utility model is granted to a new technical solution that is practicable for application and proposed in respect of the shape, structure or a combination of both of a product. A design patent is granted to the new design of a certain product in shape, pattern or a combination of both and in color, shape and pattern combinations aesthetically suitable for industrial application. Under the PRC Patent Law, the term of patent protection starts from the date of application. Patents relating to invention are effective for twenty years, patents relating to utility models are effective for ten years, and patents relating to designs are effective for fifteen years from the date of application. The PRC Patent Law adopts the principle of “first-to-file” system, which provides that if there is more than one person who files a patent application for the same invention, a patent will be granted to the person who files the application first. In China, a patent must have novelty, creativity and practical applicability. Under the PRC Patent Law, novelty means that before a patent application is filed, no identical invention or utility model has been publicly disclosed in any publication in China or overseas or has been publicly used or made known to the public by any other means, whether in or outside of China, nor has any other person filed with the patent authority an application that describes an identical invention or utility model and is recorded in patent application documents or patent documents published after the filing date. Creativity means that, compared with existing technology, an invention has prominent substantial features and represents notable progress, and a utility model has substantial features and represents any progress. Practical applicability means an invention or utility model can be manufactured or used and may produce positive results. Patents in China are filed with the China National Intellectual Property Administration (“CNIPA”). Normally, the CNIPA publishes an application for an invention patent within 18 months after the filing date, which may be shortened at the request of applicant. The applicant must apply to the CNIPA for a substantive examination within three years from the date of application. Article 19 of the PRC Patent Law provides that, for an invention or utility model completed in China, any applicant (not just Chinese companies and individuals), before filing a patent application outside of China, must first submit it to the CNIPA for a confidential examination. Any failure to comply with this requirement would result in the denial of any Chinese patent for the invention or utility model. Meanwhile, the Patent Law implements a “compensation for patent term” measure. In the event that an invention patent is granted after the fourth anniversary of the date of application and the third anniversary of the date of the request for substantive examination, the Patent Administration Department of the State Council should, at the request of the patentee, provide the compensation for patent term for the unreasonable delay in the process of granting the patent, except for the unreasonable delay caused by the applicant. In particular, in order to compensate the time taken for the review and approval of new drugs, if the new drug-related invention patents are approved for marketing in China, the Patent Administration Department of the State Council should provide the compensation for patent 90 Table of Contents term to the patentee for the duration of patent rights at the request of the patentee. The compensation for patent term should not exceed five years, and the total effective patent right period after the new drug is approved for marketing should not exceed fourteen years. Patent Enforcement Unauthorized use of patents without consent from owners of patents, forgery of the patents belonging to other persons, or engagement in other patent infringement acts, will subject the infringers to infringement liability. Serious offenses such as forgery of patents may be subject to criminal penalties. When a dispute arises out of infringement of the patent owner’s patent right, Chinese law requires that the parties first attempt to settle the dispute through mutual consultation. However, if the dispute cannot be settled through mutual consultation, the patent owner or an interested party who believes the patent is being infringed may either file a civil legal suit or file an administrative complaint with the patent administration authority. A Chinese court may issue a preliminary injunction upon the patent owner’s or an interested party’s request before instituting any legal proceedings or during the proceedings. Damages for infringement are calculated as the loss suffered by the patent holder arising from the infringement, and if the loss suffered by the patent holder arising from the infringement cannot be determined, the damages for infringement should be calculated as the benefit gained by the infringer from the infringement. If it is difficult to ascertain damages in this manner, damages may be determined by using a reasonable multiple of the license fee under a contractual license. Statutory damages may be awarded in the circumstances where the damages cannot be determined by the above-mentioned calculation standards. The damage calculation methods should be applied in the aforementioned order. Generally, the patent owner has the burden of proving that the patent is being infringed. However, if the owner of an invention patent for manufacturing process of a new product alleges infringement of its patent, the alleged infringer has the burden of proof. Medical Patent Compulsory License According to the PRC Patent Law, for the purpose of public health, the CNIPA may grant a compulsory license for manufacturing patented drugs and exporting them to countries or regions covered under international treaties to which the PRC has acceded. Trade Secrets Pursuant to the PRC Anti-Unfair Competition Law promulgated by the Standing Committee of the National People’s Congress on September 2, 1993 and amended on November 4, 2017, April 23, 2019 and June 27, 2025, respectively, the term “trade secrets” refers to technical and business information that is unknown to the public, has utility, may create business interests or profits for its legal owners or holders, and is maintained as a secret by its legal owners or holders. Under the PRC Anti-Unfair Competition Law, business persons are prohibited from infringing others’ trade secrets by (i) obtaining the trade secrets from the legal owners or holders by any unfair methods, such as theft, bribery, fraud, coercion, electronic intrusion, or any other illicit means; (ii) disclosing, using or permitting others to use the trade secrets obtained illegally under item (i), (iii) disclosing, using or permitting others to use the trade secrets in violation of any contractual agreements or any requirements of the legal owners or holders to keep such trade secrets in confidence, or (iv) instigating, inducing or assisting others to disclose, use or permit others to use the trade secrets, in violation of any contractual agreements or any requirement of the legal owners or holders to keep such trade secret in confidence. If a third party knows or should have known of the above-mentioned illegal conduct but nevertheless obtains, uses or discloses trade secrets of others, the third party may be deemed to have committed a misappropriation of the others’ trade secrets. The parties whose trade secrets are being misappropriated may petition for administrative corrections, and regulatory authorities may terminate any illegal activities and impose fines on the infringing parties. Regulations Relating to Commercial Bribery Pharmaceutical companies involved in a criminal investigation or administrative proceedings related to bribery are listed in the Adverse Records of Commercial Briberies by their respective provincial health and family planning administrative department. Pursuant to the Provisions on the Establishment of Adverse Records of Commercial Briberies in the Medicine Purchase and Sales Industry which became effective on March 1, 2014, provincial health and family planning administrative departments formulate the implementing measures for establishment of Adverse Records of Commercial Briberies. Where a pharmaceutical company or its agent is listed in the Adverse Records of Commercial Briberies on one occasion, it will be prohibited from participating in the procurement bidding process or selling its products to public medical institutions located in the local provincial-level region for two years from the publication of the adverse records. The evaluation points of such pharmaceutical company or agent in respect of the procurement bidding process and procurement by public medical institutions must be credited by public medical institutions in the other provincial-level regions for two years from the publication of the adverse records. Where a pharmaceutical company or its agent is listed in the Adverse Records of Commercial Briberies on two or more occasions within five years, it will be prohibited from participating in the procurement bidding process or selling its products to all public medical institutions in the PRC for two years from the publication of these adverse records. 91 Table of Contents Regulations Relating to Employee Stock Incentive Plan In February 2012, the SAFE promulgated the Notices on Issues Concerning the Foreign Exchange Administration for Domestic Individuals Participating in Stock Incentive Plans of Overseas Publicly Listed Companies. In accordance with this regulation and applicable rules and regulations, PRC citizens or non-PRC citizens residing in China for a continuous period of not less than one year, who participate in any stock incentive plan of an overseas publicly listed company, subject to a few exceptions, are required to register with the SAFE through a domestic qualified agent, which could be a PRC subsidiary of such overseas listed company, and complete certain procedures. We and our employees who are PRC citizens or who reside in China for a continuous period of not less than one year and who participate in our stock incentive plan will be subject to such regulation. In addition, the State Administration of Taxation has issued circulars concerning employee share options or restricted shares. Under these circulars, employees working in the PRC who exercise share options, or whose restricted shares vest, will be subject to PRC individual income tax. The PRC subsidiaries of an overseas listed company have obligations to file documents related to employee share options or restricted shares with the tax authorities and to withhold individual income tax of those employees related to their share options or restricted shares. If the employees fail to pay, or the PRC subsidiaries fail to withhold, their individual income tax according to the laws, rules and regulations, the PRC subsidiaries may face sanctions imposed by the tax authorities or other PRC government authorities. Regulations Relating to Foreign Exchange and the Dividend Distribution Foreign Exchange Control The State Council promulgated the PRC Regulation for the Foreign Exchange on January 29, 1996, which was amended on January 14, 1997 and August 5, 2008, respectively. On June 20, 1996, the People’s Bank of China promulgated the Regulation on the Administration of the Foreign Exchange Settlement, Sales and Payment, which came into effect on July 1, 1996. Pursuant to the above-mentioned regulations, foreign exchanges required for distribution of profits and payment of dividends may be purchased from designated foreign exchange banks in the PRC upon presentation of a board resolution authorizing the distribution of profits or payment of dividends. The Regulation on the Administration of the Foreign Exchange Settlement, Sales and Payment removed the previous restrictions on convertibility of foreign exchange in respect of current account items, including the distribution of dividends, interest and royalty payments, trade and service-related foreign exchange transactions, while foreign exchange transactions in respect of capital account items, such as direct investment, loan, securities investment and repatriation of investment, remain subject to the approval of the SAFE. On November 19, 2012, the SAFE issued the Operating Rules for Foreign Exchange Issues with Regard to Direct Investment under Capital Account as an appendix to the Circular of the SAFE on Further Improving and Adjusting the Foreign Exchange Policies on Direct Investment, which was issued on November 19, 2012 and amended on May 4, 2015, October 10, 2018 and December 30, 2019, respectively. According to the Circular of the SAFE on Further Improving and Adjusting the Foreign Exchange Policies on Direct Investment, (i) the opening of and payment into foreign exchange accounts under direct investment accounts are no longer subject to approval by the SAFE; (ii) reinvestment with the legal income of foreign investors in China is no longer subject to approval by the SAFE; (iii) the procedures for capital verification and confirmation that foreign-funded enterprises need to go through are simplified; (iv) the purchase and external payment of foreign exchange under direct investment accounts are no longer subject to approval by the SAFE; (v) domestic transfer of foreign exchange under direct investment accounts is no longer subject to approval by the SAFE; and (vi) the administration over the conversion of foreign exchange capital of foreign-funded enterprises is improved. On February 13, 2015, the SAFE issued the Circular on Further Simplifying and Improving Foreign Exchange Administration Policies in Respect of Direct Investment, which came into effect on June 1, 2015 and was amended on December 30, 2019, providing that the banks, instead of the SAFE, can directly handle the foreign exchange registration and approval under foreign direct investment, while the SAFE and its branches indirectly supervise the foreign exchange registration and approval under foreign direct investment through the banks. On March 30, 2015, the SAFE released the Circular on the Reform of the Management Method for the Settlement of Foreign Exchange Capital of Foreign-invested Enterprises, which came into effect on June 1, 2015 and was amended on December 30, 2019 and March 23, 2023, respectively, and superseded the Notice on the Relevant Operating Issues Concerning the Improvement of the Administration of Payment and Settlement of Foreign Currency Capital of Foreign-funded Enterprises issued by the SAFE on August 29, 2008. The Circular on the Reform of the Management Method for the Settlement of Foreign Exchange Capital of Foreign-invested Enterprises has made certain adjustments to some regulatory requirements on the settlement of foreign exchange capital of foreign-invested enterprises, and some foreign exchange restrictions provided in the Notice on the Relevant Operating Issues Concerning the Improvement of the Administration of Payment and Settlement of Foreign Currency Capital of Foreign-funded Enterprises. On June 9, 2016, the SAFE issued the Circular on the Reform and Standardization of the Management Policy of the Settlement of Capital Projects, which was amended on December 4, 2023. Under the Circular on the Reform and Standardization of the Management Policy of the Settlement of Capital Projects and the Circular on the Reform of the Management Method for the Settlement of Foreign Exchange Capital of Foreign-invested Enterprises, the settlement of foreign exchange by foreign-invested enterprises should be governed by the policy of foreign exchange settlement on a discretionary basis. However, the aforementioned circulars also reiterate that the settlement 92 Table of Contents of foreign exchange should only be used for its own operation purposes within the business scope of the foreign-invested enterprises and following the principles of authenticity. The SAFE promulgated the Circular on Relevant Issues Concerning Foreign Exchange Control on Domestic Residents’ Offshore Investment and Financing and Roundtrip Investment through Special Purpose Vehicles on July 4, 2014, which requires PRC residents to register with local branches of the SAFE in connection with their direct establishment or indirect control of an offshore entity for the purpose of overseas investment and financing, with such PRC residents’ legally owned assets or equity interests in domestic enterprises or offshore assets or interests as a “special purpose vehicle” as defined therein. The aforementioned circular further requires amendment to the registration in the event of any significant changes with respect to the special purpose vehicle. Failure to comply with the SAFE registration requirements under the Circular on Relevant Issues Concerning Foreign Exchange Control on Domestic Residents’ Offshore Investment and Financing and Roundtrip Investment through Special Purpose Vehicles could result in liabilities under PRC law for evasion of foreign exchange controls. The Circular on Further Simplifying and Improving Foreign Exchange Administration Policies in Respect of Direct Investment provides that local banks, instead of the SAFE, can directly handle the initial foreign exchange registration and amendment registration under the Circular on Relevant Issues Concerning Foreign Exchange Control on Domestic Residents’ Offshore Investment and Financing and Roundtrip Investment through Special Purpose Vehicles. On April 10, 2020, the SAFE promulgated the Circular on Optimizing Administration of Foreign Exchange to Support the Development of Foreign-related Business, which allows eligible enterprises to make domestic payments using their capital funds, foreign credits and the income under capital accounts of overseas listing, without providing evidentiary materials concerning authenticity of such capital for banks in advance, provided that their capital use should be authentic and in line with provisions, and conform to the prevailing administrative regulations on the use of income under capital accounts. The administering bank should perform ex-post sampling in accordance with the requirements. Dividend Distribution Pursuant to the PRC Company Law, the latest amended edition of which came into effect on July 1, 2024, and the Foreign Investment Law of the PRC, foreign-invested enterprises in the PRC may pay dividends only out of their accumulated profits as determined in accordance with PRC accounting standards and regulations. When a foreign-invested enterprise distributes its after-tax profit for the year, ten percent of the profit should be set aside as its statutory surplus reserve fund. The company may no longer do so if its cumulative statutory surplus reserve accounts for more than fifty percent of its registered capital. If the company’s statutory surplus reserve is insufficient to make up for the losses of previous years, the company shall use the current year’s profit to make up for the losses before the set-aside of the statutory surplus reserve. After the company has set aside a part of its after-tax profit as its statutory surplus reserve, it may also set aside a part of its after-tax profit as its discretionary reserve. Distributions can be made to shareholders only after the remaining after-tax profit have made up for losses and the surplus reserve has been set aside. On January 26, 2017, the SAFE issued the Notice on Improving the Check of Authenticity and Compliance to Further Promote Foreign Exchange Control, which stipulates several capital control measures with respect to outbound remittance of profits from domestic entities to offshore entities, including the following: (i) under the principle of genuine transaction, banks should check board resolutions regarding profit distribution, the original version of tax filing records and audited financial statements; and (ii) domestic entities should hold income to account for previous years’ losses before remitting the profits. Moreover, domestic entities should provide detailed explanations of the sources of capital and the utilization arrangements and board resolutions, contracts and other proof when completing the registration procedures in connection with an outbound investment. Regulations Relating to Enterprise Income Tax Pursuant to the Enterprise Income Tax Law of the PRC effective as of January 1, 2008 and as amended on February 24, 2017 and December 29, 2018, respectively, the income tax rate for both domestic and foreign-invested enterprises is 25% with certain exceptions. To clarify certain provisions in the Enterprise Income Tax Law, the State Council promulgated the Implementation Rules of the Enterprise Income Tax Law on December 6, 2007, which was amended on April 23, 2019 and December 6, 2024, respectively. Under the Enterprise Income Tax Law and the Implementation Rules of the Enterprise Income Tax Law, enterprises are classified as either “resident enterprises” or “non-resident enterprises.” Besides enterprises established within the PRC, enterprises established outside of China whose “de facto management bodies” are located in China are considered “resident enterprises” and subject to the uniform 25% enterprise income tax rate for their global income. In addition, the Enterprise Income Tax Law provides that a non-resident enterprise refers to an entity established under foreign law whose “de facto management bodies” are not within the PRC, but has an establishment or place of business in the PRC, or does not have an establishment or place of business in the PRC but has income sourced within the PRC. The Implementation Rules of the Enterprise Income Tax Law provide that since January 1, 2008, an income tax rate of 10% should normally be applicable to dividends declared to non-PRC resident enterprise investors that do not have an establishment or place of 93 Table of Contents business in the PRC, or have an establishment or place of business but the income is not effectively connected with the establishment or place of business, to the extent such dividends are derived from sources within the PRC. The income tax on the dividends may be reduced pursuant to a tax treaty between China and the jurisdictions in which the non-PRC resident enterprise shareholders reside. Regulations Relating to Outbound Data Transfer On July 7, 2022, the CAC promulgated the Measures on Security Assessment of Outbound Data Transfer, which became effective on September 1, 2022 and provided that data processors satisfying certain conditions are required to apply for security assessment through provincial cyberspace administrations and obtain approval from the CAC. On February 22, 2023, the CAC promulgated the Measures on Standard Contracts for Outbound Transfer of Personal Information, which became effective on June 1, 2023 and provided that personal information processors that carry out personal information outbound transfer activities by way of entering into standard contracts shall comply with certain conditions and file the standard contracts with the provincial cyberspace administrations. On March 22, 2024, the CAC promulgated the Provisions on Promoting and Regulating Cross-Border Data Flows, which became effective on the same day and further adjusted the scope and procedures applicable to the mechanisms of security assessment and filing of standard contracts and provided exemption conditions. Pursuant to the Provisions on Promoting and Regulating Cross-Border Data Flows, if a data processor transfers data out of China and falls within any of the following circumstances, security assessment shall apply: (i) a critical information infrastructure operator provides personal information or important data out of China, or (ii) a data processor other than a critical information infrastructure operator provides important data out of China, or provides personal information (excluding sensitive personal information) of more than 1 million individuals or sensitive personal information of more than 10,000 individuals out of China cumulatively from January 1 of the current year. However, the data processor will not be required to apply for such security assessment if certain exemption conditions are met. Other PRC National- and Provincial-Level Laws and Regulations We are subject to changes to many other laws and regulations administered by governmental authorities at the national, provincial and municipal levels, some of which are or may become applicable to our business, including the regulations governing the confidentiality of patients’ medical information and setting forth the circumstances under which the patients’ medical information may be released for inclusion in our databases, or released by us to third parties, which may become more restrictive in the future. We also comply with numerous additional national and provincial laws and regulations relating to matters such as safe working conditions, manufacturing practices, environmental protection and fire hazard control. We believe that we are currently in compliance with these laws and regulations; however, we may be required to incur significant costs to comply with these laws and regulations in the future. Unanticipated changes in existing regulatory requirements or adoption of new requirements could therefore have a material adverse effect on our business, results of operations and financial condition. U.S. Regulation Government Regulation and Product Approval in the United States The FDA and other regulatory authorities in the United States at federal, state and local levels extensively regulate, among other things, the research, development, testing, manufacture, quality control, import, export, safety, effectiveness, labeling, packaging, storage, distribution, recordkeeping, approval, advertising, promotion, marketing, post-approval monitoring and post-approval reporting of drug and biological products. Along with third-party contractors, we are required to navigate the various preclinical, clinical and commercial approval requirements of the governing U.S. regulatory agencies if we wish to conduct studies or seek approval or licensure of our drug candidates. Drug and biological products must be approved by a regulator before they are commercialized in the countries in which we operate. The processes for obtaining regulatory approvals in the United States, along with subsequent compliance with applicable laws and regulations and other regulatory authorities, require the expenditure of substantial time and financial resources. Government policies may change and additional government regulations may be enacted that could prevent or delay further development or regulatory approval of any of our drug candidates or anticipated manufacturing processes, disease indications or labeling. We cannot predict the likelihood, nature or extent of government regulation that might arise from future legislative or administrative action. 94 Table of Contents Review and Approval for Licensing Biologics in the United States In the United States, the FDA regulates our current drug candidates as biological products, or biologics, under the Federal Food, Drug, and Cosmetic Act (the “FDCA”), the Public Health Service Act and associated implementing regulations. Biologics, like other drugs, are used for the treatment, prevention or cure of disease in humans. In contrast to chemically synthesized small molecular weight drugs, which have a well-defined structure and can be thoroughly characterized, biologics are generally derived from living material (human, animal, or microorganism) and are complex in structure, and thus are usually not fully characterized. Biologics include immuno-oncology therapeutics for the treatment of cancer and other diseases. Biologics are also subject to other federal, state and local statutes and regulations. The failure to comply with applicable statutory and regulatory requirements at any time during the product development process, approval process or after approval may subject a sponsor or applicant to administrative or judicial enforcement actions. These actions could include the suspension or termination of clinical trials by the FDA, the FDA’s refusal to approve pending applications or supplemental applications, withdrawal of an approval, “Warning Letters” (official messages from the FDA to a manufacturer or other organization that it has violated some rule in a federally regulated activity) or “Untitled Letters” (initial correspondences from the FDA with a regulated industry that cite violations that do not meet the threshold of regulatory significance for a Warning Letter and request correction of the violation), product recalls, product seizures, total or partial suspension of production or distribution, import detention, injunctions, fines, refusals of government contracts, restitution, disgorgement of profits, or civil or criminal investigations and penalties brought by the FDA, the Department of Justice or other governmental entities. An applicant seeking approval to market and distribute a biologic in the United States typically must undertake the following: •completion of non-clinical laboratory tests and animal studies performed in accordance with the FDA’s Good Laboratory Practice regulations; •submission to the FDA of an application for an IND, which must become effective before clinical trials may begin and must be updated annually or when significant changes are made; •manufacture, labeling and distribution of an investigational drug in compliance with the FDA’s current Good Manufacturing Practice requirements; •approval by an independent institutional review board or ethics committee at each clinical site before each clinical trial may be initiated; •performance of adequate and well-controlled human clinical trials in accordance with the FDA’s current Good Clinical Practices requirements, to establish the safety, purity and potency of the proposed biological drug candidate for its intended purpose; •preparation of and submission to the FDA of a BLA, after completion of all pivotal clinical trials requesting marketing approval for one or more proposed indications; •payment of application user fees under the Prescription Drug User Fee Act; •satisfactory completion of an FDA Advisory Committee review, where appropriate or if applicable, as may be requested by the FDA to assist with its review; •satisfactory completion of one or more FDA inspections of the manufacturing facility or facilities at which the proposed product, or components thereof, are produced to assess compliance with current Good Manufacturing Practice and data integrity requirements to assure that the facilities, methods and controls are adequate to preserve the biologic’s identity, safety, quality, purity and potency; •satisfactory completion of FDA audits of selected clinical investigation sites to assure compliance with current Good Clinical Practices requirements and the integrity of the clinical data; •obtaining FDA review and approval of the biologics license application to permit commercial marketing of the licensed biologic for particular indications for use in the United States; and 95 Table of Contents •compliance with any post-approval requirements, including the potential requirement to implement a Risk Evaluation and Mitigation Strategy (“REMS”), and the potential requirement to conduct post-approval studies. The testing and approval process requires substantial time, effort and financial resources and we cannot be certain that any approvals for our drug candidates will be granted on a timely basis, if at all. From time to time, legislation is drafted, introduced and passed in the Congress of the United States that could significantly change the statutory provisions governing the testing, approval, manufacturing and marketing of products regulated by the FDA. In addition to new legislation, FDA regulations and policies are often revised or interpreted by the agency in ways that may significantly affect our business and our drug candidates. It is impossible to predict whether further legislative changes will be enacted or whether FDA regulations, guidance, policies or interpretations will be changed or what the effect of such changes, if any, may be. Preclinical and Clinical Development in the United States Before an applicant of a biologics license application can begin testing the potential asset in human subjects, the applicant must first conduct preclinical studies. Preclinical studies include laboratory evaluations of product chemistry, toxicity and formulation, as well as in vitro and animal studies to assess the potential safety and activity of the biologic for initial testing in humans and to establish a rationale for therapeutic use. Preclinical studies are subject to federal regulations and requirements, including good laboratory practice regulations. The results of an applicant’s preclinical studies are submitted to the FDA as part of an IND. An IND is a request for authorization from the FDA to administer an investigational new drug product to humans. An IND is an exemption from the FDCA that allows an unapproved drug to be shipped in interstate commerce for use in an investigational clinical trial. Such authorization must be secured prior to interstate shipment. In support of a request for an IND, applicants must submit a range of information, including preclinical data, manufacturing information and a detailed protocol for each clinical trial. Any subsequent protocol amendments must be submitted to the FDA as part of the IND. Human clinical trials may not begin until an IND is effective. The IND automatically becomes effective 30 days after receipt by the FDA, unless the FDA raises safety concerns or questions about the proposed clinical trial within the 30-day time period. In such a case, the IND may be placed on clinical hold and the IND sponsor and the FDA must resolve any outstanding concerns or questions before the clinical trial can begin. Submission of an IND therefore may or may not result in FDA authorization to begin a clinical trial. The FDA may also place a clinical hold or partial clinical hold on such trial following commencement of a clinical trial under an IND. A clinical hold is an order issued by the FDA to the sponsor to delay a proposed clinical investigation or to suspend an ongoing investigation. A partial clinical hold is a delay or suspension of only part of the clinical work requested under the IND. For example, a specific protocol or part of a protocol is not allowed to proceed, while other protocols may do so. No more than 30 days after the imposition of a clinical hold or partial clinical hold, the FDA will provide the sponsor with a written explanation of the basis for the hold. Following issuance of a clinical hold or partial clinical hold, an investigation may only resume after the FDA has notified the sponsor that the investigation may proceed. The FDA will base that determination on information provided by the sponsor correcting the deficiencies previously cited or otherwise satisfying the FDA that the investigation can proceed. Clinical trials involve the administration of the investigational product to human subjects under the supervision of qualified investigators in accordance with regulations of current Good Clinical Practices, which include the requirement that all research subjects provide their informed consent for their participation in any clinical trial. Clinical trials are conducted under protocols detailing, among other things, the objectives of the study, the parameters to be used in monitoring safety and the effectiveness criteria to be evaluated. A separate submission to the existing IND must be made for each successive clinical trial conducted during product development and for any subsequent protocol amendments. A sponsor may choose, but is not required, to conduct a foreign clinical trial under an IND. When a foreign clinical trial is conducted under an IND, all FDA IND requirements must be met unless waived. When the foreign clinical trial is not conducted under an IND, the sponsor must ensure that the study complies with regulations of current Good Clinical Practices in order to use the study as support for an IND or application for marketing approval, including review and approval by an independent ethics committee and informed consent from subjects. Furthermore, an independent institutional review board for each site proposing to conduct the clinical trial must review and approve the plan for any clinical trial and its informed consent form before the clinical trial begins at that site, and must monitor the study until completed. Regulatory authorities, the institutional review board or the sponsor may suspend a clinical trial at any time on various grounds, including a finding that the subjects are being exposed to an unacceptable health risk or that the trial is unlikely to meet its stated objectives. 96 Table of Contents Some trials also include oversight by an independent group of qualified experts organized by the clinical trial sponsor, known as a data safety monitoring board. Data safety monitoring boards provide authorization for whether or not a trial may move forward at designated check points based on access to certain data from the trial and may halt the clinical trial if a data safety monitoring board determines that there is an unacceptable safety risk for subjects or based on other grounds, such as no demonstration of efficacy. Other grounds for suspension or termination may be made based on evolving business objectives and/or competitive climate. There are also requirements governing the reporting of ongoing clinical trials and clinical trial results to public registries. Clinical Trials For purposes of approval of biologics license applications, clinical trials are typically conducted in the following sequential phases that may overlap or be combined: •Phase 1: The investigational product is initially introduced into a small number of healthy human subjects or patients with the target disease or condition. These trials are designed to test the safety, dosage tolerance, absorption, metabolism and distribution of the investigational product in humans and the side effects associated with increasing doses. •Phase 2: The investigational product is administered to a limited patient population with a specified disease or condition to evaluate the preliminary efficacy, optimal dosages and dosing schedule and to identify possible adverse side effects and safety risks. Multiple Phase 2 clinical trials may be conducted to obtain information prior to beginning larger and more expensive Phase 3 clinical trials. •Phase 3: The investigational product is administered to an expanded patient population generally at multiple geographically dispersed clinical trial sites to further evaluate dosage, to provide statistically significant evidence of clinical efficacy and to further test for safety. These clinical trials are intended to generate sufficient data to statistically evaluate the efficacy and safety of the product for approval, to establish the overall risk/benefit ratio of the investigational product and to provide an adequate basis for product approval by the FDA. In some cases, the FDA may require, or companies may voluntarily pursue, additional clinical trials after a product is approved to gain more information about the product, referred to as Phase 4 trials. Such post-approval trials, when applicable, are conducted following initial approval, typically to develop additional data and information relating to the biological characteristics of the product and treatment of patients in the intended therapeutic indication. Progress reports detailing the results of the clinical trials must be submitted at least annually to the FDA and more frequently if serious adverse events occur. In addition, IND safety reports must be submitted to the FDA for any of the following: suspected serious and unexpected adverse reactions; findings from epidemiological studies, pooled analysis of multiple studies, animal or in vitro testing, or other clinical trials, whether or not conducted under an IND, and whether or not conducted by the sponsor, that suggest a significant risk in humans exposed to the drug; and any clinically important increase in the rate of a serious suspected adverse reaction over such rate listed in the protocol or investigator brochure, which is a comprehensive document summarizing the body of information about an investigational product obtained during clinical and non-clinical trials. Each of Phase 1, Phase 2 and Phase 3 clinical trials may not be completed successfully within any specified period, or at all. Furthermore, the FDA or the sponsor may suspend or terminate a clinical trial at any time on various grounds, including a finding that the research patients are being exposed to an unacceptable health risk. Similarly, an independent institutional review board can suspend or terminate approval of a clinical trial at its institution, or an institution it represents, if the clinical trial is not being conducted in accordance with the institutional review board’s requirements or if the drug has been associated with unexpected serious harm to patients. Concurrently with clinical trials, companies often complete additional animal studies, and develop additional information about the chemistry and physical characteristics of the drug and finalize a process for manufacturing the product in commercial quantities in accordance with requirements of Good Manufacturing Practice. The manufacturing process must be capable of consistently producing quality batches of the drug candidate and, among other things, must develop methods for testing the identity, strength, quality, purity and potency of the final drug. Additionally, appropriate packaging must be selected and tested, and stability studies must be conducted to demonstrate that the drug candidate does not undergo unacceptable deterioration over its shelf life. BLA Submission and Review Assuming successful completion of all required clinical testing in accordance with all applicable regulatory requirements, an applicant may submit a biologics license application, or BLA, requesting licensing to market the biologic for one or more indications in the United States. The BLA must include the results of product development, non-clinical studies and clinical trials; detailed information 97 Table of Contents on the product’s chemistry, manufacture and controls; and proposed labeling. Under the Prescription Drug User Fee Amendments, a BLA submission is subject to an application user fee, unless a waiver or exemption applies. The FDA will initially review the BLA for completeness before accepting it for filing. Under the FDA’s procedures, the agency has 60 days from its receipt of a BLA to determine whether the application will be accepted for filing and substantive review. If the agency determines that the application does not meet this initial threshold standard, the FDA may refuse to file the application and request additional information, in which case the application must be resubmitted with the requested information and review of the application delayed. With certain exceptions, BLAs must include a pediatric assessment, generally based on clinical trial data, of the safety and effectiveness of the biologic in relevant pediatric populations. Under certain circumstances, the FDA may waive or defer the requirement for a pediatric assessment, either at the sponsor’s request or by the agency’s initiative. After the BLA is accepted for filing, the FDA reviews the BLA to determine, among other things, whether a product is safe, pure and potent and if the facility in which it is manufactured, processed, packed or held meets standards designed to assure the product’s continued identity, strength, quality, safety, purity and potency. The FDA may convene an advisory committee to provide clinical insight on application review questions. Before approving a BLA, the FDA will typically inspect the facility or facilities where the product is manufactured. The FDA will not approve an application unless it determines that the manufacturing processes and facilities comply with current Good Manufacturing Practice and are adequate to ensure consistent production of the product within required specifications. In addition, the FDA expects that all data be reliable and accurate, and requires sponsors to implement meaningful and effective strategies to manage data integrity risks. Data integrity is an important component of the sponsor’s responsibility to ensure the safety, efficacy and quality of its product or products. The FDA will typically inspect one or more clinical sites to assure compliance with regulations of current Good Clinical Practices before approving a BLA. If the FDA determines that the application, manufacturing process or manufacturing facilities are not acceptable, it will outline the deficiencies in the submission and often will request additional testing or information. Notwithstanding the submission of any requested additional information, the FDA ultimately may decide that the application does not satisfy the regulatory criteria for approval. FDA performance goals generally provide for action on a BLA within ten months of filing, which typically occurs within 60 days of submission, but that deadline is extended in certain circumstances. Furthermore, the review process is often significantly extended by FDA requests for additional information or clarification. The FDA may refer applications for novel products or products that present difficult questions of safety or efficacy to an advisory committee. Typically, an advisory committee consists of a panel that includes clinicians and other experts who will review, evaluate and provide a recommendation as to whether the application should be approved and, if so, under what conditions. The FDA is not bound by the recommendations of an advisory committee, but it considers such recommendations carefully when making decisions and usually has followed such recommendations. After the FDA evaluates a BLA and conducts inspections of manufacturing facilities where the investigational product and/or its components will be produced, the FDA may issue an approval letter or a complete response letter. An approval letter authorizes commercial marketing of the biologic with specific prescribing information for specific indications. A complete response letter will describe all of the deficiencies that the FDA has identified in the BLA, except that where the FDA determines that the data supporting the application are inadequate to support approval, the FDA may issue the complete response letter without first conducting required inspections, testing submitted product lots and/or reviewing proposed labeling. If and when the deficiencies have been addressed to the FDA’s satisfaction in a resubmission of the BLA, the FDA will issue an approval letter. In issuing the complete response letter, the FDA may recommend actions that the applicant might take to place the BLA in condition for approval, including requests for additional data, information or clarification. The FDA may delay or refuse approval of a BLA if applicable regulatory criteria are not satisfied, and may require additional testing or information and/or require post-marketing studies and clinical trials. Even with submission of this additional information, the FDA ultimately may decide that the application does not satisfy the regulatory criteria for approval. 98 Table of Contents During the approval process, the FDA will determine whether a REMS is necessary to ensure the safe use of the biologic. A REMS is a safety strategy to manage a known or potential serious risk associated with a product and to enable patients to have continued access to such medicines by managing their safe use, and could include medication guides, physician communication plans or elements to assure safe use, such as restricted distribution methods, patient registries and other risk minimization tools. If the FDA concludes that a REMS is needed, the BLA sponsor must submit a proposed REMS and the FDA will not approve the BLA without a REMS that the agency has determined is acceptable. In addition, under the Pediatric Research Equity Act, certain applications or supplements must contain data that are adequate to assess the safety and effectiveness of the drug for the claimed indications in all relevant pediatric subpopulations, and to support dosing and administration for each pediatric subpopulation for which the product is safe and effective. The FDA may, on its own initiative or at the request of the applicant, grant deferrals for submission of some or all pediatric data until after approval of the product for use in adults, or full or partial waivers from the pediatric data requirements. If the FDA approves a product, it may limit the approved indications for use for the product, or require that contraindications, warnings or precautions be included in the product labeling. The FDA may also require that post-approval studies, including Phase 4 clinical trials, be conducted to further assess the drug’s safety after approval. The FDA may prevent or limit further marketing of a product based on the results of post-marketing studies or surveillance programs. The FDA may also require testing and surveillance programs to monitor the product after commercialization. For biologics, such testing may include official lot release, which requires the manufacturer to perform certain tests on each lot of the product before it is released for distribution. The manufacturer then typically must submit samples of each lot of product to the FDA, together with a release protocol showing a summary of the history of manufacture of the lot and the results of all of the manufacturer’s tests performed on the lot. The FDA may also perform certain confirmatory tests on lots of some products itself, before releasing the lots for distribution by the manufacturer. After approval, many types of changes to the approved product, such as adding new indications, manufacturing changes and additional labeling claims, are often subject to further testing requirements and FDA review and approval, depending on the nature of the post-approval change. The FDA may withdraw the product approval if compliance with pre- and post-marketing requirements is not maintained or if problems occur after the product reaches the marketplace. Post-Approval Requirements Any products manufactured or distributed pursuant to FDA approvals are subject to pervasive and continuing regulation by the FDA, including, among other things, requirements relating to recordkeeping, periodic reporting, reporting of certain deviations and adverse experiences, product sampling and distribution and advertising and promotion of the product. After approval, most changes to the approved product, such as adding new indications or other labeling claims, are subject to FDA review and approval. There also are continuing user fee requirements, under which the FDA assesses an annual program fee for each product identified in an approved BLA. Biologic manufacturers and their third-party contractors are required to register their establishments with the FDA and certain state agencies. These establishments are subject to routine and periodic unannounced inspections by the FDA and certain state agencies for compliance with current Good Manufacturing Practice and data integrity requirements, which impose certain procedural and documentation requirements to assure quality of manufacturing and product. Requirements with respect to data integrity include, among other things, controls to ensure data are complete and secure; activities documented at the time of performance; audit trail functionality; authorized access and limitations; validated computer systems; and review of records for accuracy, completeness and compliance with established standards. Post-approval changes to the manufacturing process are strictly regulated, and, depending on the significance of the change, may require FDA approval before being implemented. FDA regulations also require investigation and correction of any deviations from current good manufacturing practice and impose reporting requirements upon us and any third-party manufacturers that we may decide to use. Accordingly, manufacturers must continue to expend time, money and effort in the area of production and quality control to maintain compliance with current good manufacturing practice, data integrity, pharmacovigilance (i.e., post-marketing safety reporting obligations) and other aspects of regulatory compliance. The FDA may withdraw a product approval if compliance with regulatory requirements and standards is not maintained or if problems occur after the product reaches the market. Later discovery of previously unknown problems with a product, including adverse events of unanticipated severity or frequency, or with manufacturing processes, or failure to comply with regulatory requirements, may 99 Table of Contents result in revisions to the approved labeling to add new safety information; imposition of post-approval studies or clinical trials to assess new safety risks; or imposition of distribution or other restrictions under a REMS. Other potential consequences include: •restrictions on the marketing or manufacturing of a product, complete withdrawal of the product from the market or product recalls; •fines, Warning Letters, Untitled Letters or holds on post-approval clinical trials; •refusal of the FDA to approve pending applications or supplements to approved applications, or suspension or revocation of existing product approvals; •product seizure or detention, or refusal of the FDA to permit the import or export of products that it believes present safety problems by issuing an Import Alert; •permanent injunctions and consent decrees, including the imposition of civil or criminal penalties; or •recall ordered by the FDA or voluntary product recall. The FDA strictly regulates the marketing, labeling, advertising and promotion of prescription drug products placed on the market. A company can make only those claims relating to safety and efficacy, purity and potency that are approved by the FDA and in accordance with the provisions of the approved label. The FDA’s regulation includes, among other things, standards and regulations for direct-to-consumer advertising, communications regarding unapproved uses, industry-sponsored scientific and educational activities and promotional activities involving the Internet and social media. Promotional claims relating to a product’s safety or effectiveness are prohibited before the drug is approved. After approval, a product generally may not be promoted for uses that are not approved by the FDA, as reflected in the product’s prescribing information. In the United States, healthcare professionals are generally permitted to prescribe drugs for such uses not described in the drug’s labeling, known as off-label uses, because the FDA does not regulate the practice of medicine. However, FDA regulations impose rigorous restrictions on manufacturers’ communications, prohibiting the promotion of off-label uses. Rather, manufacturers are permitted to market and promote their products exclusively for the indications for which they have been approved. It may be permissible, under very specific, narrow conditions, for a manufacturer to engage in non-promotional, non-misleading communication regarding off-label information, such as distributing scientific or medical journal information. If a company is found to have promoted off-label uses, it may become subject to adverse public relations and administrative and judicial enforcement by the FDA, the U.S. Department of Justice or the Office of the Inspector General of the Department of Health and Human Services, as well as other federal and state authorities. This could subject a company to a range of penalties that could have a significant commercial impact, including civil and criminal fines and agreements that materially restrict the manner in which a company promotes or distributes products. The federal government has levied large civil and criminal fines against companies for alleged improper promotion, and has also requested that companies enter into consent decrees and permanent injunctions under which specified promotional conduct is changed or curtailed. The distribution of prescription drugs and biologics are subject to the Drug Supply Chain Security Act, which requires manufacturers and other stakeholders to comply with product identification, tracing, verification, detection and response, notification and licensing requirements. In addition, the Prescription Drug Marketing Act, and its implementing regulations, and state laws limit the distribution of prescription pharmaceutical product samples, and the Drug Supply Chain Security Act imposes requirements to ensure accountability in distribution and to identify and remove prescription drug and biological products that may be counterfeit, stolen, contaminated, or otherwise harmful from the market. Patent Term Restoration and Marketing Exclusivity After approval, owners of biological product patents may apply for up to a five-year patent term extension to restore a portion of patent term lost during product development and FDA review of a BLA if approval of the application is the first permitted commercial marketing or use of a biologic containing the active ingredient under the Hatch-Waxman Amendments. The allowable patent term extension is calculated as one-half of the product’s testing phase, which is the time between IND and BLA submission, and all of the review phase, which is the time between BLA submission and approval, up to a maximum of five years. The time can be shortened if the FDA determines that the applicant did not pursue approval with due diligence. The total patent term after the extension may not exceed more than 14 years from the date of FDA approval of the product. Only one patent claiming each approved product is eligible for restoration and the patent holder must apply for restoration within 60 days of approval. The United States Patent and Trademark Office, in consultation with the FDA, reviews and approves the application for patent term restoration. 100 Table of Contents For patents that might expire during the application phase, the patent owner may request an interim patent extension. An interim patent extension increases the patent term by one year and may be renewed up to four times. For each interim patent extension granted, the post-approval patent extension is reduced by one year. The director of the United States Patent and Trademark Office must determine that approval of the biological drug candidate covered by the patent for which a patent extension is being sought is likely. Interim patent extensions are not available for a biological drug candidate for which a BLA has not been submitted. Expedited Development and Review Programs The FDA is required to facilitate the development and expedite the review of pharmaceutical products that are intended for the treatment of a serious or life-threatening condition for which there is no effective treatment and which demonstrate the potential to address unmet medical need for the condition. Under the fast track program, the sponsor of a new drug candidate may request the FDA to designate the product for a specific indication as a fast track product concurrent with or after the filing of the IND for the drug candidate. The FDA must determine if the drug candidate qualifies for fast track designation within 60 days after receipt of the sponsor’s request. In addition to other benefits, such as the ability to have more frequent interactions with the FDA, the agency may initiate review of sections of a fast track product’s BLA before the application is complete. This rolling review is available if the applicant provides and the FDA approves a schedule for the submission of the remaining information and the applicant pays applicable user fees. However, the FDA’s review period for a fast track application does not begin until the last section of the BLA is submitted. In addition, the fast track designation may be withdrawn by the FDA if the agency believes that the designation is no longer supported by data emerging in the clinical trial process. Healthcare Regulation Pharmaceutical Coverage and Reimbursement Significant uncertainty exists as to the coverage and reimbursement status of any products for which we may obtain regulatory approval. In the United States, sales of any products for which we may receive regulatory approval for commercial sale will depend in part on the availability of coverage and reimbursement from third-party payors. Third-party payors include government authorities, managed care providers, private health insurers and other organizations. Third-party payors establish the coverage and reimbursement policies for pharmaceutical products, and the marketability of any products for which we may receive regulatory approval for commercial sale depends on those payors’ coverage policies and reimbursement rates. Third-party payors may limit coverage to specific products on an approved list, or formulary, which might not include one or more of our drug candidates, if approved. Third-party payors, together with regulators and others, are increasingly challenging the prices charged for pharmaceutical products and health services, in addition to their cost-effectiveness, safety and efficacy. In addition, no uniform policy for coverage and reimbursement exists in the United States. Third-party payors often rely upon Medicare coverage policy and payment limitations in setting their own coverage and reimbursement policies, but also have their own methods and approval process apart from Medicare determinations. Therefore, coverage and reimbursement rates can vary significantly from payor to payor. Further, coverage policies and third-party payor reimbursement rates may change at any time. Even if favorable coverage and reimbursement status is attained for a product for which we receive regulatory approval, less favorable coverage policies and reimbursement rates may be implemented in the future. Moreover, obtaining coverage and adequate reimbursement is a time-consuming and costly process. We may be required to provide scientific and clinical support for the use of any product to each third-party payor separately with no assurance that approval will be obtained, and we may need to conduct expensive pharmacoeconomic studies in order to demonstrate the cost-effectiveness of our products. We cannot be certain that our drug candidates will be considered cost-effective by third-party payors. This process could delay the market acceptance of any drug candidates for which we may receive approval and could have a negative effect on our future revenues and operating results. Other U.S. Healthcare Laws and Compliance Requirements In the United States, our business may be subject to healthcare fraud and abuse regulation and enforcement by both the federal government and the states in which we conduct our business, particularly once third-party reimbursement becomes available for one or more of our products. The healthcare fraud and abuse laws and regulations that may affect our ability to operate include: •The federal Anti-Kickback Statute, which prohibits, among other things, knowingly and willfully soliciting, receiving, offering or paying any remuneration (including any kickback, bribe or rebate), directly or indirectly, overtly or covertly, in cash or in kind, to induce, or in return for, either the referral of an individual, or the purchase, lease, order or recommendation of any 101 Table of Contents good, facility, item or service for which payment may be made, in whole or in part, under the Medicare and Medicaid programs, or other federal healthcare programs; •The federal civil and criminal false claims laws and civil monetary penalty laws, including the civil False Claims Act, which prohibits, among other things, knowingly presenting, or causing to be presented, claims for payment of government funds that are false or fraudulent, or knowingly making, or using or causing to be made or used, a false record or statement material to a false or fraudulent claim to avoid, decrease, or conceal an obligation to pay money to the federal government; •The federal Health Insurance Portability and Accountability Act of 1996, which, among other things, prohibits executing a scheme to defraud any healthcare benefit program, including private third-party payors, and prohibits (i) knowingly and willfully falsifying, concealing or covering up a material fact or making any materially false, fictitious or fraudulent statement or representation and (ii) making or using any false writing or document knowing the same to contain any materially false, fictitious or fraudulent statement or entry in connection with the delivery of or payment for healthcare benefits, items or services; •The Health Insurance Portability and Accountability Act of 1996, as amended by the Health Information Technology for Economic and Clinical Health Act of 2009, and their respective implementing regulations, which impose requirements relating to the privacy, security and transmission of individually identifiable health information held by covered entities, including health plans, healthcare clearinghouses and certain healthcare providers, and their business associates, individuals or entities that perform certain services on behalf of a covered entity that involve the use or disclosure of individually identifiable health information, and their covered subcontractors. The Health Information Technology for Economic and Clinical Health Act of 2009 also created new tiers of civil monetary penalties, amended Health Insurance Portability and Accountability Act of 1996 to make civil and criminal penalties directly applicable to business associates and gave state attorneys general new authority to file civil actions for damages or injunctions in federal courts to enforce the Health Insurance Portability and Accountability Act of 1996 and seek attorneys’ fees and costs associated with pursuing federal civil actions; •The federal Physician Payments Sunshine Act, being implemented as the Open Payments Program, which requires manufacturers of drugs, devices, biologics and medical supplies for which payment is available under Medicare, Medicaid or the Children’s Health Insurance Program (with certain exceptions) to report annually to the Centers for Medicare and Medicaid Services, information related to direct or indirect payments and other transfers of value to physicians, certain other non-physician health care professionals (such as physicians assistants and nurse practitioners), and teaching hospitals, as well as ownership and investment interests held in a company by physicians and their immediate family members; and •U.S. state and local laws and regulations, such as state anti-kickback and false claims laws, which may apply to sales or marketing arrangements and claims involving healthcare items or services reimbursed by non-governmental third-party payors, including private insurers; state laws that require pharmaceutical companies to comply with the pharmaceutical industry’s voluntary compliance guidelines and the compliance guidance promulgated by the federal government or otherwise restrict payments that may be made to healthcare providers; state laws that restrict the ability of manufacturers to offer co-pay support to patients for certain prescription drugs; state laws that require drug manufacturers to report information related to clinical trials, or information related to payments and other transfers of value to physicians and other healthcare providers or marketing expenditures; state laws that require drug manufacturers to report information on the pricing of certain drugs; state laws and local ordinances that require identification or licensing of sales representatives; and state laws governing the privacy and security of health information in certain circumstances, many of which differ from each other in significant ways and often are not preempted by the Health Insurance Portability and Accountability Act of 1996, thus complicating compliance efforts. We will be required to spend substantial time and money to ensure that our business arrangements with third parties comply with applicable healthcare laws and regulations. Even then, governmental authorities may conclude that our business practices do not comply with current or future statutes, regulations or case law involving applicable fraud and abuse or other healthcare laws and regulations. If governmental authorities find that our operations violate any of these laws or any other governmental regulations that may apply to us, we may be subject to significant civil, criminal and administrative penalties, damages, fines, disgorgement, individual imprisonment, exclusion from government funded healthcare programs, such as Medicare and Medicaid, and additional reporting obligations and oversight if we become subject to a corporate integrity agreement or other agreement to resolve allegations of non-compliance with these laws, and we may be required to curtail or restructure our operations. Moreover, we expect that there will continue to be federal and state laws and regulations, proposed and implemented, that could impact our operations and business. In addition, the approval and commercialization of any drug candidate we develop outside the United States will also likely subject us to foreign equivalents of the healthcare laws mentioned above, among other foreign laws. The extent to which future legislation or regulations, if any, relating to health care fraud and abuse laws or enforcement, may be enacted or what effect such legislation or regulation would have on our business remains uncertain. 102 Table of Contents Healthcare Reform In the United States there have been, and continue to be, several legislative and regulatory changes and proposed reforms of the healthcare system to contain costs, improve quality and expand access to care that have significantly affected the pharmaceutical industry. For example, the ACA, as amended by the Health Care and Education Reconciliation Act of 2010 in March 2010, substantially changing the way healthcare is financed by both governmental and private insurers and significantly impacting the U.S. pharmaceutical industry. Since its enactment, there have been congressional, judicial, and executive challenges and amendments to the ACA, which have resulted in delays in the implementation of, and action taken to repeal or replace, certain aspects of the ACA. For example, on August 16, 2022, the IRA was signed into law, which among other things, extends enhanced subsidies for individuals purchasing health insurance coverage in ACA marketplaces through plan year 2025. The IRA also eliminates the “donut hole” under the Medicare Part D program beginning in 2025 by significantly lowering the beneficiary maximum out-of-pocket cost through a newly established manufacturer discount program. It is possible that the ACA will be subject to judicial or Congressional challenges or additional health reform measures of the second Trump administration will impact the ACA and our business. Another area of increased legislative and regulatory focus in the United States is private equity investment in healthcare companies. Various efforts by the CMS, congress, and state legislators have proposed reforms intended to increase ownership disclosure and transparency by private equity-backed healthcare companies due to their perceived role in rising healthcare costs. This continued congressional scrutiny may result in the passage of legislation or promulgation of regulations that could require disclosure of financial and ownership information to the federal government as a condition of participation in federal healthcare programs. Additionally, there has been increasing legislative and enforcement interest in the United States with respect to specialty drug pricing practices. Specifically, there have been several U.S. Congressional inquiries and proposed and enacted federal and state legislation designed to, among other things, bring more transparency to drug pricing; reduce the cost of prescription drugs under Medicare; review the relationship between pricing and manufacturer patient programs; and reform government program reimbursement methodologies for drugs. For example, the IRA, among other things, (i) directs the Secretary of the HHS to negotiate through the Medicare Drug Negotiation Program, and (ii) imposes rebates under Medicare Part B and Medicare Part D to penalize price increases that outpace inflation. These provisions began to effect progressively in fiscal year 2023 although the Medicare Drug Price Negotiation Program is currently subject to legal challenge. On August 15, 2024, HHS announced the agreed-upon prices of the first ten drugs, which became effective on January 1, 2026. On January 17, 2025, HHS selected fifteen additional drugs covered under Part D for price negotiation with agreements signed on March 14, 2025 and negotiated prices effective in 2027. On January 27, 2026, 15 drugs were selected for the third negotiation cycle (effective 2028). Each year thereafter more Part B and Part D products will become subject to the Medicare Drug Price Negotiation Program. At the state level, legislatures have increasingly passed legislation and implemented regulations designed to control pharmaceutical and biological product pricing, including price or patient reimbursement constraints, discounts, and restrictions on certain product access. In some cases, such legislation and regulations have been designed to encourage importation from other countries and bulk purchasing. Additionally, in July 2025, the One Big Beautiful Bill Act (“OBBBA”) was enacted into law. The OBBBA implements spending cuts to certain federal healthcare programs, including Medicaid and the ACA. The OBBBA amends certain provisions of the IRA, including those related to exclusion from negotiation for certain orphan drugs and biologics, but the overall impact of the OBBBA on the IRA remains uncertain and it is unclear how the IRA will be effectuated or further changed under the current administration or the degree of impact that the IRA may ultimately have upon our business, or whether additional drug pricing and other healthcare reform measures will be enacted, and if enacted, what effect they would have on our business. We expect that additional U.S. federal healthcare reform measures will be adopted in the future, any of which could limit the amounts that the U.S. federal government will pay for healthcare products and services, which could result in reduced demand for our current or any future product candidates or additional pricing pressures. We cannot predict the likelihood, nature or extent of government regulation that may arise from future legislation or administrative action in the U.S. or any other jurisdiction. However, we anticipate that Congress, state legislatures, and third-party payors may continue to review and assess alternative healthcare delivery and payment systems and may in the future propose and adopt legislation or policy changes or implementations effecting additional fundamental changes in the healthcare delivery system. We also expect ongoing legislative and regulatory initiatives to increase pressure on drug pricing. If we or any third parties we may engage are slow or unable to adapt to changes in existing or new requirements or policies, or if we or such third parties are not able to maintain regulatory compliance, our current or any future product candidates we may develop may lose any regulatory approval that may have been obtained and we may not achieve or sustain profitability. Manufacturing and Supply Following the divestiture of our Greater China assets and business operations, we primarily rely on contract development and manufacturing organizations (“CDMOs”) to manufacture our drug candidates. 103 Table of Contents We currently outsource the manufacturing of clinical trial material for our clinical stage projects to leading CDMOs in China such as WuXi Biologics, which have established track records for both clinical trial material supply and commercial material supply. We have assembled a seasoned internal and external team with deep experience in this area to drive and monitor this process. For contingency planning purposes, we have also established relationships with other CDMOs. We expect to continue our outsourcing relationships with contract manufacturers to meet the ongoing needs for the development of our drug candidates. We have framework agreements with these external service providers, under which they provide services to us on a project-by-project basis. We also monitor the manufacturing activities of clinical trial material at CDMOs to ensure compliance with local and international current good manufacturing practice and applicable regulations. Currently, our contract manufacturers obtain raw materials and supplies for the manufacturing activities from multiple suppliers who we believe have sufficient capacity to meet our demands. We typically order materials and services on a purchase order basis. We also enter into long-term capacity or minimum supply arrangements with them. Historically, we invested in a manufacturing facility under construction by TJBio Hangzhou and, through our wholly-owned subsidiary, were the largest shareholder of TJBio Hangzhou. In connection with the divestiture of our Greater China assets and business operations, we have transferred most of the equity interests we held in TJBio Hangzhou to certain participating shareholders of TJBio Hangzhou in exchange for extinguishment of the existing repurchase obligations owed by I-Mab Hong Kong to those shareholders in the amount of approximately $183 million. We may seek to contract with TJBio Hangzhou or other manufacturing facilities to manufacture our drug candidates in the future, which could add to our costs. Code of Conduct We have formulated a code of conduct that covers business ethics, responsible research and development activities, public relations, intellectual property and data protection, workplace, assets, corporate governance, concerns reporting and other behaviors, and serves as a guide for all employees and third parties to take compliance actions in business activities. We have arranged compliance training courses for newly hired employees to help them understand the business code of conduct that falls in line with industry and our standards. We also conducted an annual training for all employees to review the code of conduct. C.Organizational Structure The following chart illustrates our company’s updated organizational structure, including our principal subsidiaries, as of the date of this annual report: D.Property, Plant and Equipment Our headquarters is located in Rockville, MD, where we lease and occupy approximately 8,006 square feet of office space. In addition, we also lease approximately: (a) 2,153 square feet of office space in Short Hills, NJ; (b) 474 square feet of office space in Tianjin, China; and (c) 11,635 square feet of office and laboratory space in San Diego, CA. The terms of these leases range from one year to seven years. We have entered a sublease with respect to our San Diego, CA location with similar economic terms to our master lease agreement with the landlord. 104 Table of Contents