Benmelstobart

Phase 2 studies ongoing to advance global development of vebreltinib, a highly potent, de-risked and differentiated c-MET Inhibitor with best-in-class and first-in-class potential. To date, more than 600 patients and 170 healthy volunteers have been dosed with vebreltinib in clinical trials. Phase 2/3 IND submission for development of vebreltinib in combination with an EGFR inhibitor in the U.S. and select Asian countries for the treatment of NSCLC. FOSTER CITY, Calif., April 27, 2026 (GLOBE NEWSWIRE) -- Apollomics Inc. (Nasdaq: APLM), a clinical-stage biopharmaceutical company advancing innovative oncology therapies to transform the treatment landscape for patients with few or no options, today announced financial results for the full year ended December 31, 2025. “Our primary focus is to advance the global development of vebreltinib for the treatment of patients with c-MET alterations across different tumors,” said Hung-wen (Howard) Chen, Chief Executive Officer of Apollomics. “Based on guidance from the U.S. Food and Drug Administration (FDA), we anticipate submitting an Investigational New Drug Application for accelerated approval of vebreltinib for second-line treatment for non-small cell lung cancer (NSCLC) patients with c-MET amplification in the first half of 2027.” Pipeline Update Vebreltinib (APL-101) – a highly specific, CNS-penetrant c-MET inhibitor for treating NSCLC, brain tumors, and other solid tumors with MET dysregulation. It also shows significant potential in combination regimens, particularly with EGFR inhibitors. The China rights of APL-101 were out-licensed to Apollomics’ partner, Beijing Avistone Biotechnology Co., Ltd., while Apollomics retains the global (ex-China) rights. Vebreltinib has been approved by China’s National Medical Products Administration (NMPA) for three distinct indications: METex14 skipping NSCLC, MET-amplified NSCLC, and PTPRZ1-MET fusion high-grade gliomas. Notably, it is the first c-MET inhibitor approved for the latter two conditions. The Company is advancing global development of vebreltinib, prioritizing NSCLC with c-MET amplification while expanding its application across diverse MET alterations and tumor types. Simultaneously, the Company is investigating strategic combinations with other tumor inhibitors to fully maximize vebreltinib’s therapeutic potential. The Phase 2 component of the SPARTA clinical study, APL-101-01, is an ongoing open-label multi-cohort study for evaluation of efficacy and safety of vebreltinib for the treatment of a number of solid tumors, including NSCLC with MET Exon 14 skipping, NSCLC with c-MET amplification, brain tumors with MET fusion or MET amplification and other solid tumors with MET amplification or MET fusion. Apollomics is currently conducting the ongoing Phase 2 portion of the global SPARTA study at approximately 25 study sites in over 10 countries in North America, Europe and Asia-Pacific. As of April 2026, over 282 subjects have enrolled in the SPARTA study. Interim efficacy and safety data from the global multi-cohort Phase 2 SPARTA trial and from the multi-cohort Phase 2 KUNPENG trial demonstrated that vebreltinib appeared efficacious in NSCLC patients with MET Exon14 skipping mutation with or without co-occurring MET amplification. In March 2025, the Company announced a development and commercialization agreement for vebreltinib with LaunXP International Co., Ltd., an affiliate of LaunXP Biomedical Co., Ltd (Collectively, “LaunXP”). LaunXP will receive exclusive development and commercialization rights for vebreltinib in combination with an EGFR inhibitor in Asia (excluding mainland China, Hong Kong and Macau) for the treatment of NSCLC. Apollomics is committed to expanding its clinical pipeline through ongoing collaborations with global partners. These efforts will focus on investigating new combination therapies that maximize vebreltinib’s efficacy, ensuring the asset’s potential is fully realized across diverse patient populations. Immuno-Oncology Product Candidates APL-501 (Anti-PD-1 antibody) : APL-501 is an investigational, humanized, IgG4 monoclonal antibody that selectively binds to PD-1 on T lymphocytes and other immune cells. The China rights of APL-501 were out-licensed to Apollomics’ partner, Edding Genor Group Holdings Ltd., while Apollomics retains the global (ex-China) rights. Data from a Phase 1 study in advanced or relapsed/refractory solid tumors in Australia are currently being analyzed. APL-502 (benmelstobart, anti-PD-L1 antibody) : APL-502 is a novel IgG1 humanized monoclonal antibody against PD-L1. The China rights of APL-502 were out-licensed to Apollomics’ partner, Chia Tai-Tianqing Pharmaceutical Holdings Co., Ltd. (CTTQ), while Apollomics retains the global (ex-China) rights. APL-502 (also known as TQB-2450 in China) has been approved by China’s NMPA for three distinct indications: extensive-stage small cell lung cancer, recurrent/metastatic endometrial cancer, and late-stage unresectable or metastatic renal cell carcinoma. Ongoing clinical trials include the following tumor types: NSCLC, esophageal cancer, ovarian cancer, hepatocellular carcinoma, cholangiocarcinoma, primary mediastinal large B cell lymphoma, and alveolar soft part sarcoma. Business Highlights New senior management team : In September 2025, Apollomics appointed a new management team, led by Hung-wen (Howard) Chen, Chief Executive Officer, and Yi-kuei (Alex) Chen, Chief Operating Officer, and Peter Lin, Chief Financial Officer. Positive Turnaround Developments : With the appointment of a new board of directors and management team, the Company has made meaningful progress executing its strategic turnaround plan. In 2025, the Company successfully implemented significant cost reduction initiatives to streamline operations and enhance financial discipline. In parallel, Apollomics has strengthened its financial and legal position through the resolution of legacy matters, including the settlement of the Cayman litigation in November 2025, and the clearance of substantial outstanding legal and clinical program-related obligations. Furthermore, Apollomics has a renewed commitment to advancing its pipeline, including the relaunch of a previously paused clinical program for vebreltinib. Full Year 2025 Financial Results Cash, cash equivalents, bank deposits and money market funds as of December 31, 2025, were approximately $3.3 million, compared with $9.8 million as of December 31, 2024. In September 2025, the Company raised $4.1 million in a private investment in public equity (PIPE) financing, before transaction expenses. Revenue for the full year 2025 was $8.5 million compared to $0 for full year 2024. Revenue in 2025 is a result of the upfront payment related to the LaunXP licensing agreement for the development and commercialization in Asia (excluding mainland China, Hong Kong and Macau) of vebreltinib. Research and development expenses were approximately $5.5 million for full year 2025, compared to approximately $24.6 million for full year 2024. General and administrative expenses were approximately $12.4 million for full year 2025, compared to approximately $17.8 million for full year 2024. Net loss for the full year 2025 was $(10.9) million, or $(7.57) per diluted share, compared with a net loss of $(53.9) million, or $(52.80) per diluted share, for the full year 2024. As part of its strategic turnaround plan, Apollomics significantly reduced costs and expenses in 2025 compared to the previous year. For the full year 2025, operating expenses were $19.8 million compared to $55.7 million for the prior year, representing a 64% decrease year-over-year. About Apollomics Inc. Apollomics Inc. is an innovative clinical-stage biopharmaceutical company focused on the discovery and development of oncology therapies with the potential to be combined with other treatment options to harness the immune system and target specific molecular pathways to inhibit cancer. Apollomics’ lead program is vebreltinib (APL-101), a potent, selective c-MET inhibitor for the treatment of non-small cell lung cancer and other advanced tumors with c-MET alterations, which is currently in a Phase 2 multicohort clinical trial in the United States and other countries. For more information, please visit . Cautionary Statement Regarding Forward-Looking Statements This press release includes statements that constitute “forward-looking statements” within the meaning of the federal securities laws, including Section 27A of the Securities Act of 1933, as amended (the “Securities Act”), and Section 21E of the Securities Exchange Act of 1934, as amended (the “Exchange Act”). All statements, other than statements of present or historical fact included in this press release, regarding Apollomics’ strategy, prospects, plans, objectives and anticipated outcomes from the development and commercialization of vebreltinib are forward-looking statements. When used in this press release, the words “could,” “should,” “will,” “may,” “believe,” “anticipate,” “intend,” “estimate,” “expect,” “seek,” “project,” the negative of such terms and other similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain such identifying words. These forward-looking statements are based on management’s current expectations and assumptions about future events and are based on currently available information as to the outcome and timing of future events. In addition, Apollomics cautions you that the forward-looking statements contained in this press release are subject to unknown risks, uncertainties and other factors, including those risks and uncertainties discussed in the Annual Report on Form 20-F for the year ended December 31, 2025, filed by Apollomics Inc. with the U.S. Securities and Exchange Commission (“SEC”) under the heading “Risk Factors” and the other documents or to be by Apollomics with the SEC. Additional information concerning these and other factors that may impact the operations and projections discussed herein can be found in the reports that Apollomics has filed and will time to time with the SEC. Forward-looking statements speak only as of the date made by Apollomics. Apollomics undertakes no obligation to update publicly any of its forward-looking statements to reflect actual results, new information or future events, changes in assumptions or changes in other factors affecting forward-looking statements, except to the extent required by applicable law. Investor Contacts Peter Lin, Chief Financial Officer Apollomics, Inc. 1-650-209-4055 peter.lin@apollomicsinc.com Peter Vozzo ICR Healthcare Peter.Vozzo@icrhealthcare.com 1-443-213-0505 APOLLOMICS INC. CONSOLIDATED STATEMENTS OF PROFIT OR LOSS AND OTHER COMPREHENSIVE LOSS (All amounts in thousands of $, except for per share data) Years Ended December 31, 2025 2024 2023 $ $ $ Revenue $ 8,500 $ — $ — Other income 494 1,489 1,217 Foreign exchange (losses) gains (141 ) 145 1,191 Fair value change of financial assets at FVTPL — 198 821 Fair value change of financial liabilities at FVTPL (22 ) 222 1,597 Fair value change of convertible preferred shares — — (76,430 ) Research and development expenses (5,531 ) (24,566 ) (34,193 ) Administrative expenses (12,442 ) (17,768 ) (20,641 ) Impairment of intangible assets (1,717 ) (13,000 ) — Finance costs (65 ) (179 ) (150 ) Other expense (12 ) (140 ) (46,003 ) Loss before taxation (10,936 ) (53,599 ) (172,591 ) Income tax expenses (3 ) (259 ) (10 ) Loss and total comprehensive loss for the period, net of taxation, attributable to owners of the Company (10,939 ) (53,858 ) (172,601 ) Loss per share Basic and diluted ($) (7.57 ) (52.80 ) (231.99 ) APOLLOMICS INC. CONDENSED STATEMENTS OF FINANCIAL POSITION (All amounts in thousands of $) As of December 31, 2025 2024 $ $ Non-current assets Plant and equipment, net $ 3 $ 92 Right-of-use assets 577 927 Intangible assets, net — 1,737 Rental deposits 83 75 Total non-current assets 663 2,831 Current assets Deposits, prepayments and deferred expenses 470 501 Accounts receivable 2,305 — Cash and cash equivalents 3,276 9,766 Total current assets 6,051 10,267 Total assets 6,714 13,098 Current liabilities Other payables and accruals 6,117 7,166 Lease liabilities, current portion 209 233 Total current liabilities 6,326 7,399 Net current (liabilities) assets (275 ) 2,868 Total assets less current liabilities 388 5,699 Non-current liabilities Lease liabilities, non-current portion 434 733 Warrant liabilities at fair value through profit and loss (“FVTPL”) 124 102 Other non-current liabilities 3,018 — Total non-current liabilities 3,576 835 Net (liabilities) assets $ (3,188 ) $ 4,864 Equity Share capital 21 11 Share premium 670,384 666,528 Reserves 38,169 39,148 Accumulated deficits (711,762 ) (700,823 ) Total (deficit) equity $ (3,188 ) $ 4,864

Researchers across 79 centers in China reported that a combination regimen of programmed death-ligand 1 (PD-L1) inhibitor benmelstobart plus the multi-kinase inhibitor anlotinib produced statistically significant improvements in progression-free survival over pembrolizumab monotherapy in PD-L1-positive, driver gene-negative advanced non-small-cell lung cancer (NSCLC), according to the CAMPASS Phase III trial. The results were published in The Lancet Oncology. The trial, funded by Chia Tai Tianqing Pharmaceutical Group, enrolled 531 patients and represents one of the first randomized Phase III datasets to demonstrate head-to-head superiority over pembrolizumab in this setting. Chia Tai is responsible for discovering benmelstobart and development in Greater China, while US-based biotech Apollomics partnered with the China-based firm for rights outside China. Pembrolizumab monotherapy has held a dominant position as first-line treatment for PD-L1-positive advanced NSCLC since its approval based on the KEYNOTE-024 and KEYNOTE-042 trials. However, a substantial proportion of patients progress within a year, and response rates in the broader PD-L1-positive population—defined as tumor proportion score (TPS) of 1% or greater—remain around 30% to 40%. The CAMPASS trial was designed to test whether adding anlotinib, a multi-target anti-angiogenic tyrosine kinase inhibitor, to the PD-L1-targeted benmelstobart could improve outcomes without the addition of chemotherapy. The CAMPASS results The trial randomized patients 2:1, with 354 receiving benmelstobart plus anlotinib and 177 receiving pembrolizumab plus placebo. Patients were aged 18 to 75 years, had an ECOG performance status of 0 or 1, and had no targetable EGFR or ALK mutations. Both squamous and non-squamous histologies were included. Enrollment ran from August 2021 through December 2022 across 79 sites in China. The primary endpoint was progression-free survival assessed by blinded independent central review per RECIST v1.1. Median PFS in the experimental arm was not reached at the time of analysis, compared with 8.9 months in the pembrolizumab arm. The hazard ratio was 0.51 (95% CI: 0.39–0.67; p<0.0001). The 12-month PFS rate was approximately 60% with benmelstobart plus anlotinib versus approximately 40% with pembrolizumab. The PFS benefit was consistent across prespecified subgroups, including patients with TPS 1%–49% and ≥50%, as well as across squamous and non-squamous histologies. Overall survival data, while still maturing with both medians not yet reached, showed a hazard ratio of 0.62 (95% CI: 0.44–0.88; p0.007), indicating an early OS signal in favor of the combination. The objective response rate was approximately 63% in the experimental arm versus 39% in the pembrolizumab arm, a statistically significant difference. The mechanistic rationale for the combination centers on the relationship between tumor angiogenesis and immune suppression. Tumors upregulate VEGF signaling to promote vascular growth, but this process also creates an immunosuppressive microenvironment by reducing T-cell infiltration and promoting regulatory T-cell accumulation. Anlotinib inhibits VEGFR, FGFR, PDGFR, and c-Kit, which normalizes tumor vasculature and is thought to improve T-cell trafficking into the tumor. Benmelstobart then blocks the PD-1/PD-L1 axis, reactivating cytotoxic T-cells within a more accessible microenvironment. The hypothesis is that anti-angiogenic therapy potentiates checkpoint inhibition by making tumors more immunologically permissive, rather than relying on checkpoint blockade alone. The safety profile reflected the dual-agent mechanism. Grade 3 or higher treatment-related adverse events occurred in approximately 60% of patients in the benmelstobart plus anlotinib arm, compared with approximately 35% in the pembrolizumab arm. Anlotinib-related toxicities, particularly hypertension and proteinuria, accounted for a meaningful share of the higher adverse event burden. Treatment discontinuation rates were higher in the experimental arm, however, no new or unexpected safety signals were identified. The investigators characterized the toxicity as manageable with dose modifications. Research context The CAMPASS regimen represents one among several competing approaches to the same problem. Akeso’s ivonescimab, a bispecific antibody targeting both PD-1 and VEGF within a single molecule, reported superiority over pembrolizumab in the HARMONi-2 Phase III trial in 2024 in a Chinese PD-L1-positive NSCLC population. Summit Therapeutics holds ex-China rights to ivonescimab, and the asset has attracted considerable attention as a potential pembrolizumab alternative in the first-line setting. The bispecific format is mechanistically adjacent to the CAMPASS combination but consolidates both activities into one molecule, which may carry pharmacokinetic and dosing advantages. Other China-developed IO combinations—including camrelizumab plus apatinib from Jiangsu Hengrui and sintilimab plus anlotinib from Innovent—are also in late-stage evaluation in overlapping populations. Roche’s atezolizumab plus bevacizumab plus chemotherapy (IMpower150) is approved in non-squamous NSCLC but includes cytotoxic chemotherapy, a distinction that the CAMPASS regimen avoids. The chemotherapy-free design is a feature it shares with the ivonescimab approach, with both positioning against pembrolizumab monotherapy in PD-L1-positive advanced NSCLC. The CAMPASS dataset was generated entirely in China, which carries implications for regulatory and commercial strategy. The trial population reflects a Chinese clinical context, and generalizability to Western populations will require additional data or bridging studies before regulatory submissions outside China. The benmelstobart program is also being evaluated in extensive-stage small-cell lung cancer, where a Phase III trial published in Nature Medicine in 2024 suggests Chia Tai Tianqing is pursuing a broader oncology footprint for the combination platform. Leave a Reply Cancel reply Your email address will not be published. Required fields are marked * Comment * Name * Email * Website