Nivolumab

The HDAC inhibitor pipeline remains active, with several next-generation agents advancing in clinical trials. Abexinostat (Xynomic Pharmaceuticals) is in Phase III development for renal cell carcinoma, representing a potential expansion into solid tumors. Quisinostat (Viriom) is in Phase II for uveal melanoma, and Entinostat, partnered between EOC Pharma and Syndax, is being explored in Hodgkin lymphoma. LAS VEGAS, Aug. 20, 2025 /PRNewswire/ -- DelveInsight's HDAC Inhibitors Market Size, Target Population, Competitive Landscape & Market Forecast report includes a comprehensive understanding of current treatment practices, addressable patient population, which includes top indications such as Multiple Myeloma, Peripheral T-cell Lymphoma (PTCL), Cutaneous T-cell Lymphoma (CTCL), Amyotrophic Lateral Sclerosis (ALS), and others. The selected indications are based on approved therapies and ongoing pipeline activity. The report also provides insights into the emerging HDAC inhibitors, market share of individual therapies, and current and forecasted market size from 2020 to 2034, segmented into 7MM. Key Takeaways from the HDAC Inhibitors Market Report As per DelveInsight's analysis, the total market size of HDAC inhibitors in the 7MM is expected to surge significantly by 2034. The report provides the total potential number of patients in the indications, such as Multiple Myeloma, Peripheral T-cell Lymphoma (PTCL), Cutaneous T-cell Lymphoma (CTCL), Amyotrophic Lateral Sclerosis (ALS), and others. Leading HDAC inhibitor companies, such as Xynomic Pharmaceuticals, Viriom, EOC Pharma, Syndax Pharmaceuticals, Jubilant Therapeutics, and others, are developing novel HDAC inhibitors that can be available in the HDAC inhibitors market in the coming years. Some of the key HDAC inhibitors in the pipeline include Abexinostat, Quisinostat, Entinostat, JBI-802, and others. Discover which indication is expected to grab the major HDAC inhibitors market share @ HDAC Inhibitors Market Report HDAC Inhibitors Overview Histone deacetylases (HDACs) remove acetyl groups from both histone and non-histone proteins. Because acetylation of histones is linked to an open chromatin structure and active gene transcription, HDAC activity leads to histone deacetylation and epigenetic suppression of gene expression. Since HDACs influence many pathways involved in cancer development, HDAC inhibitors (HDACis) show clinical effects through several mechanisms, including changes in gene expression of cell cycle and apoptotic proteins, acetylation of other proteins involved in cell growth and survival, effects on angiogenesis, aggresome formation, and DNA repair. There are 18 known HDACs, divided into two major groups and four classes based on their cellular location, homology, enzyme mechanism, sequence of discovery, and histone substrate specificity. The first group includes zinc-dependent HDACs, which all share a similar catalytic core for deacetylating acetyl-lysine residues. These comprise Class I (HDAC1, -2, -3, -8), Class II (IIa: HDAC4, -5, -7, -9; IIb: HDAC6, -10), and Class IV (HDAC11). The second group includes Class III HDACs (sirtuins, SIRT1–7), which rely on NAD+ for their enzymatic activity. HDAC Inhibitors Epidemiology Segmentation The HDAC inhibitors market report proffers epidemiological analysis for the study period 2020–2034 in the 7MM, segmented into: Total Cases of Selected Indications for HDAC Inhibitor Total Eligible Patient Pool of Selected Indications for HDAC Inhibitor Total Treated Cases of Selected Indications for HDAC Inhibitor HDAC Inhibitors Treatment Market Several HDAC inhibitors are currently available on the market. Recent entrants include DUVYZAT (givinostat), while earlier approved drugs include BELEODAQ (belinostat), HIYASTA (tucidinostat), among others. DUVYZAT is a histone deacetylase inhibitor approved for treating Duchenne muscular dystrophy (DMD) in patients aged 6 and above. While it is categorized as an HDAC inhibitor, its exact mechanism of action in DMD is not fully understood. In April 2025, Italfarmaco announced that the CHMP of the European Medicines Agency (EMA) issued a positive opinion on DUVYZAT. The drug is also being evaluated in other indications: Phase III trial in Becker muscular dystrophy (BMD) and Phase II trial in polycythemia vera. HIYASTA (HBI-8000) is an epigenetic immunomodulator approved for several indications, including use as monotherapy for certain subtypes of relapsed or refractory T-cell non-Hodgkin's lymphoma, specifically adult T-cell leukemia-lymphoma (ATLL) and peripheral T-cell lymphoma (PTCL) in Japan. HUYABIO International is conducting a multinational Phase III trial evaluating HIYASTA in combination with nivolumab for previously untreated metastatic or unresectable malignant melanoma. HIYASTA is an oral HDAC Class I inhibitor that induces cell cycle arrest and apoptosis in tumor cells, which underlies its efficacy in lymphoma. In September 2020, the Japanese Ministry of Health, Labour and Welfare (MHLW) granted orphan drug designation (ODD) to HIYASTA for relapsed/refractory ATL, and in December 2015 for PTCL. In June 2021, HUYABIO also received regulatory approval in Japan for HBI-8000 as monotherapy for relapsed/refractory ATL. Key Emerging HDAC Inhibitors and Companies Xynomic Pharmaceuticals (Abexinostat), Viriom (Quisinostat), EOC Pharma/Syndax Pharmaceuticals (Entinostat), Jubilant Therapeutics (JBI-802), and several other companies are currently engaged in the development and production of HDAC inhibitors, which have the potential to significantly impact and enhance the HDAC inhibitors market. Abexinostat, an oral, broad-spectrum HDAC inhibitor originally developed by Pharmacyclics and later licensed by Xynomic Pharmaceuticals in 2017, has demonstrated encouraging activity in both blood cancers and solid tumors. The drug is currently being studied in several Phase I to III clinical trials worldwide. In September 2019, Xynomic announced that the FDA had granted Fast Track Designation (FTD) to abexinostat as a monotherapy for fourth-line treatment of relapsed or refractory follicular lymphoma. The FDA had previously granted FTD for abexinostat in combination with pazopanib for first- or second-line therapy in renal cell carcinoma. Additional Phase II trials are underway in indications such as Diffuse Large B-cell Lymphoma (DLBCL) and Follicular Lymphoma. Quisinostat is another potent, selective oral pan-HDAC inhibitor, initially developed by Janssen Pharmaceuticals. HDAC inhibitors work by inducing cell cycle arrest, promoting differentiation, and triggering apoptosis in various human cancer cell lines. By inhibiting histone deacetylase, they increase acetylation of histone proteins, resulting in a more transcriptionally active chromatin state and altered gene expression involved in proliferation, apoptosis, and differentiation. Multiple preclinical studies and Phase I/II trials have evaluated quisinostat's safety and effectiveness, showing promising anti-tumor effects in several advanced and treatment-resistant cancers — including platinum-resistant ovarian cancer (in combination with paclitaxel and carboplatin), uveal melanoma, and synovial sarcoma. The anticipated launch of these emerging therapies are poised to transform the HDAC inhibitors market landscape in the coming years. As these cutting-edge therapies continue to mature and gain regulatory approval, they are expected to reshape the HDAC inhibitors market landscape, offering new standards of care and unlocking opportunities for medical innovation and economic growth. To know more about HDAC inhibitors clinical trials, visit @ HDAC Inhibitors Treatment Recent Developments in the HDAC Inhibitors Space In May 2025, Amylyx Pharmaceuticals announced positive Week 48 data from the Phase II open-label HELIOS clinical trial of AMX0035 in adults living with Wolfram syndrome. In May 2025, the University of Miami, in collaboration with Viriom, initiated a Phase II clinical trial in the US (NCT06932757) to evaluate an oral therapy for patients with uveal melanoma who have undergone at least one prior line of treatment. In April 2025, Xynomic Pharmaceuticals concluded a Phase I/II clinical trial in the United States (NCT03939182), evaluating a combination oral therapy for patients with Diffuse Large B-cell Lymphoma and Mantle Cell Lymphoma who had received at least one prior line of treatment. Discover more about HDAC inhibitors in development @ HDAC Inhibitors Clinical Trials HDAC Inhibitors Market Dynamics HDAC inhibitors are a class of epigenetic drugs that modify gene expression by altering chromatin structure. Initially developed as anticancer agents, they have shown significant therapeutic potential in various malignancies, especially hematologic cancers like T-cell lymphoma and multiple myeloma. The market initially gained traction with FDA approvals of drugs such as Vorinostat, Romidepsin, and Panobinostat. Their unique mechanism of action targeting epigenetic regulation drew interest as precision medicine and oncology research grew, driving pharmaceutical investment in this segment. The HDAC inhibitors market continues to expand largely due to the rising prevalence of cancer worldwide and the need for more targeted therapies with better safety profiles. Additionally, ongoing clinical trials are exploring HDAC inhibitors in combination with other therapies, such as immune checkpoint inhibitors, proteasome inhibitors, and traditional chemotherapeutics. These combination approaches aim to overcome resistance and enhance efficacy, creating more opportunities for market growth. As more data emerges demonstrating synergistic benefits, partnerships between biotech startups and large pharmaceutical firms are accelerating further development. Despite this positive outlook, the market faces several challenges. Many HDAC inhibitors are associated with toxicity issues such as fatigue, gastrointestinal disturbances, and thrombocytopenia, which limit broader adoption. Competition from newer targeted therapies and immuno-oncology drugs also puts pressure on the HDAC inhibitor segment. Moreover, several compounds failed in late-stage trials due to a lack of efficacy, leading to cautious investor sentiment and prioritization of combination rather than monotherapy approaches. Looking ahead, the market dynamics are expected to be shaped increasingly by precision oncology trends and biomarker-driven patient selection, allowing more effective targeting of responders. If safety profiles can be improved and combination regimens continue to show strong results, HDAC inhibitors will retain a meaningful role in the evolving oncology landscape. Novel formulations, selective HDAC isoform inhibitors, and expansion into non-oncology indications such as neurodegenerative or inflammatory diseases may further diversify the market and drive its next phase of growth. Learn more about the HDAC inhibitors @ HDAC Inhibitors Analysis Scope of the HDAC Inhibitors Market Report HDAC Inhibitors Therapeutic Assessment: HDAC Inhibitors' current marketed and emerging therapies HDAC Inhibitors Market Dynamics: Conjoint Analysis of Emerging HDAC Inhibitor Drugs Competitive Intelligence Analysis: SWOT analysis and Market entry strategies Unmet Needs, KOL's views, Analyst's views, HDAC Inhibitors Market Access and Reimbursement Table of Contents Related Reports Multiple Myeloma Market Multiple Myeloma Market Insights, Epidemiology, and Market Forecast – 2034 report delivers an in-depth understanding of the disease, historical and forecasted epidemiology, as well as the market trends, market drivers, market barriers, and key multiple myeloma companies, including Sanofi, Karyopharm Therapeutics, Takeda Pharmaceutical, Celgene, Bristol-Myers Squibb, RAPA Therapeutics, Pfizer, Array Biopharma, Cellectar Biosciences, BioLineRx, Celgene, Aduro Biotech, ExCellThera, Janssen Pharmaceutical, Precision BioSciences, Takeda, Glenmark (Ichnos Sciences SA), Poseida Therapeutics, Molecular Partners AG, Chipscreen Biosciences, AbbVie, Genentech (Roche), Janssen Biotech, Nanjing Legend Biotech, Merck Sharp & Dohme Corp., among others. 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Cutaneous T-cell Lymphoma Market Cutaneous T-cell Lymphoma Market Insights, Epidemiology, and Market Forecast – 2034 report delivers an in-depth understanding of the disease, historical and forecasted epidemiology, as well as the market trends, market drivers, market barriers, and key CTCL companies, including Pfizer, Helsinn Therapeutics, Kyowa Hakko Kirin, Citius Pharmaceuticals, Soligenix, Prescient Therapeutics, Innate Pharma, Bristol-Myers Squibb, BioInvent International AB, among others. About DelveInsight DelveInsight is a leading Business Consultant and Market Research firm focused exclusively on life sciences. It supports pharma companies by providing comprehensive end-to-end solutions to improve their performance. Get hassle-free access to all the healthcare and pharma market research reports through our subscription-based platform PharmDelve . Contact Us Shruti Thakur [email protected] +14699457679 Logo: SOURCE DelveInsight Business Research, LLP WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

Positive givastomig Phase 1b dose escalation data in combination with immunochemotherapy in patients with 1L gastric cancers presented at ESMO GI 2025 showing 83% ORR at doses selected for ongoing expansion studyTopline data from planned dose expansion study of givastomig expected in Q1 2026Strengthened balance sheet with net proceeds of approximately $61.2 million from August 2025 underwritten offering; pro-forma cash balance of approximately $226.8 million as of June 30, 2025, after giving effect to the offering; expected to fund planned operating expenses and capital expenditures through the fourth quarter of 2028 ROCKVILLE, Md., Aug. 20, 2025 (GLOBE NEWSWIRE) -- I-Mab (NASDAQ: IMAB) (I-Mab or the Company), a U.S.-based, global biotech company, focused on the development of precision immuno-oncology agents for the treatment of cancer, today announced financial results for the three and six months ended June 30, 2025, and highlighted recent pipeline progress and business updates. “The first half of 2025 has been transformative for I-Mab,” said Sean Fu, PhD, Chief Executive Officer of I-Mab. “Our presentation at ESMO GI showcased compelling Phase 1b combination data for givastomig, reinforcing our confidence in its potential to be a best-in-class Claudin 18.2-directed therapy for metastatic gastric cancers in the 1L setting. Thanks to strong study momentum and active investigator engagement, we completed enrollment of the planned Phase 1b dose expansion cohorts ahead of schedule and expect to report topline data in Q1 2026. We believe our strong cash position and unwavering focus on value creation, position I-Mab to deliver meaningful clinical data and improve the lives of patients.” Recent and Anticipated Upcoming Clinical Milestones Givastomig (CLDN18.2 x 4-1BB bispecific): Recent Developments: Positive Phase 1b Dose Escalation Data in Combination with Immunochemotherapy Presented at ESMO GI 2025 – Data from the dose escalation cohorts of the study were presented on July 2, 2025 in a Mini Oral presentation at the European Society for Medical Oncology Gastrointestinal Cancers Congress (ESMO GI) 2025 in Barcelona, Spain, accessible here. The data showed that givastomig in combination with immunochemotherapy demonstrated an 83% (10/12) objective response rate (ORR) at the doses (8 mg/kg and 12 mg/kg) selected for dose expansion. The responses were rapid, durable and deepened over time, with a favorable overall safety profile.I-Mab hosted a virtual investor event on July 8, 2025 reviewing the Phase 1b dose escalation data (accessible for viewing here). Givastomig Monotherapy Data Published in Clinical Cancer Research – First-in-human monotherapy data for givastomig were published in Clinical Cancer Research, a journal of the American Association for Cancer Research (CCR), and a highly-ranked clinical oncology publication. The CCR paper details promising clinical data showing that givastomig monotherapy achieved an ORR of 16% in heavily pretreated Claudin 18.2-positive gastric cancer patients without encountering a dose limiting toxicity or maximum tolerated dose. The publication can be accessed here. The study provided the foundation for the ongoing Phase 1b combination study. Upcoming Potential Clinical Milestones: I-Mab completed enrollment in the planned Phase 1b dose expansion study evaluating givastomig in combination with nivolumab and mFOLFOX6 for first line (1L) metastatic gastric cancers. The Company expects to present topline data in Q1 2026. Other Programs: I-Mab anticipates updates in 2026 for ragistomig (PD-L1 x 4-1BB bispecific) and uliledlimab (monoclonal antibody targeting CD73), which are currently under development by ABL Bio and TJ Biopharma, respectively. Corporate Developments I-Mab Announces Pricing of $65 Million Underwritten Offering – I-Mab completed an underwritten offering of American Depositary Shares (ADSs) representing ordinary shares that raised total net proceeds of approximately $61.2 million. The offering included participation from new and existing investors including Everest Medicines, Janus Henderson Investors, Adage Capital Partners LP and Exome Asset Management. Givastomig Intellectual Property Portfolio Strengthened with Acquisition of Bridge Health – The acquisition provides I-Mab with upstream rights to the Claudin 18.2 parental antibody for use in bispecific and multi-specific applications, eliminates all royalty obligations and reduces future milestones for givastomig due to Bridge Health Biotech Co., Ltd. (Bridge Health) by I-Mab. The transaction is expected to close in Q3 2025. Cash Position As of June 30, 2025, the Company had cash and cash equivalents, and short-term investments of $165.6 million. The Company expects that its existing cash and cash equivalents, and short-term investments, together with the net proceeds from the August 2025 underwritten offering, will be sufficient to fund its operating expenses and capital expenditure requirements through the fourth quarter of 2028, including through a randomized Phase 2 trial of givastomig. Shares Outstanding As of June 30, 2025, the Company had 188,108,178 ordinary shares issued and outstanding, representing the equivalent of 81,786,164 ADSs, assuming the conversion of all ordinary shares into ADSs. In August 2025, the Company announced an underwritten offering of 76,666,659 ordinary shares, representing the equivalent of 33,333,330 ADSs. Pro-forma for the underwritten offering, the Company had 264,774,837 ordinary shares issued and outstanding, representing the equivalent of 115,119,494 ADSs, assuming the conversion of all ordinary shares into ADSs. Research and Development Expenses Research and development (R&D) expenses were $3.3 million and $4.1 million for the three and six months ended June 30, 2025, respectively, compared to $5.2 million and $11.3 million for the three and six months ended June 30, 2024, respectively. R&D expenses for the three months ended June 30, 2025 were $1.9 million lower than the comparable period in 2024, primarily due to lower contract research organization costs driven by streamlined clinical pipeline activities and a decrease in employee-related expenses resulting from a lower headcount. R&D expenses for the six months ended June 30, 2025 were $7.2 million lower than the comparable period in 2024, primarily due to reimbursements recognized under an existing collaboration agreement and lower contract research organization costs due to streamlined clinical pipeline activities. Administrative Expenses Administrative expenses were $3.8 million and $8.3 million for the three and six months ended June 30, 2025, respectively, compared to $11.9 million and $14.4 million for the three and six months ended June 30, 2024, respectively. Administrative expenses for the three months ended June 30, 2025 were $8.1 million lower than the comparable period in 2024, primarily due to lower legal expenses and a decrease in employee-related expenses resulting from a lower headcount. Administrative expenses for the six months ended June 30, 2025 were $6.1 million lower than the comparable period in 2024, primarily due to a decrease in legal expenses and lower employee benefit and compensation expenses resulting from a lower headcount. This decrease was partially offset by a higher employee share-based compensation expense in the current period. The employee share-based compensation expense during the six months ended June 30, 2024 included forfeitures in connection with the divestiture of our Chinese assets and related operations (the Greater China assets and business operations). Interest Income Interest income was $1.8 million and $3.7 million for the three and six months ended June 30, 2025, respectively, compared to $2.1 million and $2.8 million for the three and six months ended June 30, 2024, respectively. Interest income for the three months ended June 30, 2025 was $0.3 million lower than the comparable period in 2024 due to lower average cash balances and lower market interest rates. Interest income for the six months ended June 30, 2025 was $0.8 million higher than the comparable period in 2024, primarily due to greater interest earned on cash balances as a result of cash management strategies. Other Income (Expenses), Net Other income (expenses), net were $(0.2) million and $0.1 million for the three and six months ended June 30, 2025, respectively, compared to $6.1 million and $5.5 million for the three and six months ended June 30, 2024, respectively. The $6.3 million and $5.4 million decreases in other income (expense), net for the three and six months ended June 30, 2025, respectively, were primarily attributable to the changes in fair value and extinguishment of certain put right liabilities. The decrease was partially offset by smaller impacts from foreign exchange losses recognized during the current period. Equity in Loss of Affiliates Equity in loss of affiliates was $(1.0) million for the six months ended June 30, 2024 due to recognition of the employee stock ownership plan expenses from the Company's unconsolidated investee as a result of the divestiture of the Greater China assets and business operations. There was no equity in loss of affiliates for the three months ended June 30, 2024 or the three and six months ended June 30, 2025. Net Loss from Continuing Operations Net loss from continuing operations were ($5.5) million and $(8.7) million for the three and six months ended June 30, 2025, respectively, compared to $(8.9) million and $(18.4) million for the three and six months ended June 30, 2024, respectively. Net loss from continuing operations per share attributable to ordinary shareholders were $(0.03) and $(0.05) for the three and six months ended June 30, 2025, respectively, compared to $(0.05) and $(0.10) for the three and six months ended June 30, 2024, respectively. Net Gain from Discontinued Operations On April 2, 2024, the Company closed the divestiture of the Greater China assets and business operations announced on February 7, 2024 (the Transaction). In accordance with ASC 205-20, the Company determined that the Transaction represented a strategic shift that had a major effect on the business and therefore, met the criteria for classification as discontinued operations. As a result, the Company recognized a loss from discontinued operations of $6.9 million for the six months ended June 30, 2024 and a gain from sale of discontinued operations of $34.4 million for the three and six months ended June 30, 2024. Net Income (Loss) Net income (loss) was $(5.5) million and $(8.7) million for the three and six months ended June 30, 2025, respectively, compared to $25.4 million and $9.1 million for the three and six months ended June 30, 2024, respectively. Net income (loss) per share attributable to ordinary shareholders was $(0.03) and $(0.05) for the three and six months ended June 30, 2025, respectively compared to $0.13 and $0.05 for the three and six months ended June 30, 2024, respectively. About Givastomig Givastomig (TJ033721 / ABL111) is a bispecific antibody targeting Claudin 18.2 (CLDN18.2)-positive tumor cells. It conditionally activates T cells through the 4-1BB signaling pathway in the tumor microenvironment where CLDN18.2 is expressed. Givastomig is being developed for first line (1L) metastatic gastric cancers, with further potential in other solid tumors. In Phase 1 trials, givastomig has shown promising anti-tumor activity attributable to a potential synergistic effect of proximal interaction between CLDN18.2 on tumor cells and 4-1BB on T cells in the tumor microenvironment, while minimizing toxicities commonly seen with other 4-1BB agents. An ongoing Phase 1b study is evaluating givastomig for the treatment of gastric cancer in the 1L setting in combination with standard of care, nivolumab (an anti-PD-1 checkpoint inhibitor) plus chemotherapy, in dose escalation (n=17) and dose expansion (n=40) cohorts. The study builds on positive Phase 1 monotherapy data. Givastomig is being jointly developed through a global partnership with ABL Bio, in which I-Mab is the lead party and shares worldwide rights, excluding Greater China and South Korea, equally with ABL Bio. About I-Mab I-Mab (NASDAQ: IMAB) is a U.S.-based, global biotech company, focused on the development of precision immuno-oncology agents for the treatment of cancer. The Company’s differentiated pipeline is led by givastomig, a potential best-in-class, bispecific antibody (Claudin 18.2 x 4-1BB) designed to treat Claudin 18.2-positive gastric cancers. Givastomig conditionally activates T cells via the 4-1BB signaling pathway in the tumor microenvironment where Claudin 18.2 is expressed. Givastomig is being developed for first-line metastatic gastric cancers, with additional potential in other solid tumors. In Phase 1 trials, givastomig was observed to maintain strong tumor-binding and anti-tumor activity, attributable to a potential synergistic effect of proximal interaction with Claudin 18.2 and 4-1BB, while minimizing toxicities commonly seen with other 4-1BB agents. For more information, please visit https://www.i-mabbiopharma.com and follow us on LinkedIn. Forward Looking Statements This announcement contains forward-looking statements. These statements are made under the “safe harbor” provisions of the U.S. Private Securities Litigation Reform Act of 1995. These forward-looking statements can be identified by terminology such as “will”, “expects”, “believes”, “designed to”, “anticipates”, “future”, “intends”, “plans”, “potential”, “estimates”, “confident”, and similar terms or the negative thereof. I-Mab may also make written or oral forward-looking statements in its periodic reports to the U.S. Securities and Exchange Commission (the “SEC”), in its annual report to shareholders, in press releases and other written materials and in oral statements made by its officers, directors or employees to third parties. Statements that are not historical facts, including statements about I-Mab’s beliefs and expectations, are forward-looking statements. Forward-looking statements in this press release include, without limitation, statements regarding: the potential benefits and clinical development of I-Mab’s drug candidates, including givastomig; anticipated clinical milestones and results, and related timing; the Company’s anticipated cash runway; the potential closing of the Bridge Health acquisition in Q3 2025. Forward-looking statements involve inherent risks and uncertainties that may cause actual results to differ materially from those contained in these forward-looking statements, including but not limited to the following: I-Mab’s ability to demonstrate the safety and efficacy of its drug candidates; the clinical results for its drug candidates, which may or may not support further development or New Drug Application/Biologics License Application (NDA/BLA) approval; the content and timing of decisions made by the relevant regulatory authorities regarding regulatory approval of I-Mab’s drug candidates; I-Mab’s ability to achieve commercial success for its drug candidates, if approved; I-Mab’s ability to obtain and maintain protection of intellectual property for its technology and drugs; I-Mab’s reliance on third parties to conduct drug development, manufacturing and other services; I-Mab’s limited operating history and I-Mab’s ability to obtain additional funding for operations and to complete the development and commercialization of its drug candidates; and those risks more fully discussed in the “Risk Factors” section in I-Mab’s annual report on Form 20-F filed with the SEC on April 3, 2025 as well as the discussions of potential risks, uncertainties, and other important factors in I-Mab’s subsequent filings with the SEC. All forward-looking statements are based on information currently available to I-Mab. I-Mab undertakes no obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events, or otherwise, except as may be required by law. I-Mab Investor & Media Contacts PJ Kelleher LifeSci Advisors +1-617-430-7579 pkelleher@lifesciadvisors.com IR@imabbio.com I-MabConsolidated Balance Sheets(Unaudited; All amounts in thousands, except for par value and share data) As of As of June 30, 2025 December 31, 2024 Assets Current assets Cash and cash equivalents $165,404 $68,263 Short-term investments 210 105,135 Prepayments and other receivables 2,026 3,295 Total current assets 167,640 176,693 Property, equipment and software 172 201 Operating lease right-of-use assets 3,209 3,597 Investments at fair value, available-for-sale debt securities (amortized cost of $38,727) 34,468 30,824 Other non-current assets 1,219 1,365 Total assets $206,708 $212,680 Liabilities and shareholders’ equity Current liabilities Accruals and other payables $6,494 $7,638 Operating lease liabilities, current 853 816 Total current liabilities 7,347 8,454 Operating lease liabilities, non-current 2,628 3,066 Total liabilities 9,975 11,520 Shareholders’ equity Ordinary shares ($0.0001 par value, 800,000,000 shares authorized as of June 30, 2025 and December 31, 2024; 188,108,178 and 187,452,495 shares issued and outstanding as of June 30, 2025 and December 31, 2024, respectively) 19 19 Treasury stock (5,609) (6,225)Additional paid-in capital 1,459,977 1,460,021 Accumulated other comprehensive income 37,039 33,384 Accumulated deficit (1,294,693) (1,286,039)Total shareholders’ equity 196,733 201,160 Total liabilities and shareholders’ equity $206,708 $212,680 I-MabConsolidated Statements of Comprehensive Loss(Unaudited; All amounts in thousands, except for share and per share data) Three Months Ended June 30, Six Months Ended June 30, 2025 2024 2025 2024 Revenues Licensing and collaboration revenue $— $— $— $— Total revenues — — — — Expenses Research and development expenses(1) (3,294) (5,203) (4,071) (11,265)Administrative expenses(2) (3,820) (11,937) (8,309) (14,378)Total expenses (7,114) (17,140) (12,380) (25,643)Loss from operations (7,114) (17,140) (12,380) (25,643)Interest income 1,800 2,131 3,672 2,840 Other income (expenses), net (190) 6,067 54 5,480 Equity in loss of affiliates(3) — — — (1,038)Loss from continuing operations before income tax expense (5,504) (8,942) (8,654) (18,361)Income tax expense — — — — Loss from continuing operations (5,504) (8,942) (8,654) (18,361) Discontinued operations: Loss from operations of discontinued operations(4) — — — (6,898)Income tax expense — — — — Gain on sale of discontinued operations — 34,364 — 34,364 Gain from discontinued operations — 34,364 — 27,466 Net income (loss) (5,504) 25,422 (8,654) 9,105 Other comprehensive income (loss): Unrealized gain on available-for-sale debt securities, net of tax $3,644 $— $3,644 $— Foreign currency translation adjustments, net of tax 8 (348) 11 677 Total comprehensive income (loss) $(1,852) $25,074 $(4,999) $9,782 Weighted-average number of ordinary shares used in calculating net income (loss) per share - basic and diluted 187,908,339 186,144,822 187,794,543 186,001,615 Net loss from continuing operations per share - basic and diluted $(0.03) $(0.05) $(0.05) $(0.10)Net income from discontinued operations per share - basic and diluted $— $0.18 $— $0.15 Net income (loss) per share - basic and diluted $(0.03) $0.13 $(0.05) $0.05 Net loss from continuing operations per ADS(5) - basic and diluted $(0.07) $(0.11) $(0.11) $(0.23)Net income from discontinued operations per ADS(5) - basic and diluted $— $0.42 $— $0.34 Net income (loss) per ADS(5) - basic and diluted $(0.07) $0.31 $(0.11) $0.11 (1) Includes share-based compensation expense of $(0.1) million and $(0.1) million for the three and six months ended June 30, 2025, respectively and $0.3 million for the six months ended June 30, 2024. Share-based compensation expense for the three months ended June 30, 2024 was de minimis. (2) Includes share-based compensation expense of $0.4 million and $0.6 million for the three and six months ended June 30, 2025, respectively, and $1.2 million and $(3.4) million for the three and six months ended June 30, 2024, respectively. The six months ended June 30, 2024 balances include forfeitures as a result of divestiture of the Greater China assets and business operations and organizational changes. (3) Includes share-based compensation expense of $(0.7) million for the six months ended June 30, 2024, which includes forfeitures as a result of divestiture of the Greater China assets and business operations. (4) Includes share-based compensation expense of $(11.6) million for the six months ended June 30, 2024, which includes forfeitures as a result of divestiture of the Greater China assets and business operations. (5) Each 10 ADSs represents 23 ordinary shares.