On March 16, 2026 Aprea Therapeutics, Inc. (Nasdaq: APRE) ("Aprea", or the "Company"), a clinical-stage precision medicine oncology company focused on the discovery and development of targeted therapies for patients with biomarker-defined cancers, reported financial results for the fourth quarter and full year ended December 31, 2025, and provided a business update.

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"We enter 2026 with strong momentum following a year of meaningful execution across our portfolio," said Oren Gilad, Ph.D., President and Chief Executive Officer of Aprea. "We are particularly encouraged by the most recent data from the ongoing ACESOT trial evaluating APR-1051, including two patients achieving unconfirmed partial responses at first scan. These results provide early proof of clinical concept for APR-1051 and strengthen our conviction in the product’s ability to deliver a favorable therapeutic window, supporting its potential to be a differentiated WEE1 kinase inhibitor for patients with genomically defined solid tumors who have limited treatment options. We strengthened our balance sheet with successful private placements in late 2025 and early 2026, enhancing our financial flexibility and positioning the Company to execute on key development milestones. Taken together, we believe the recent progress underscores the opportunity within our DDR portfolio and reinforces our goal of developing targeted cancer therapies that have the potential to improve outcome and quality of life for patients, while also creating value for our shareholders."

Key Business Updates and Potential Upcoming Key Milestones

ACESOT-1051: A Biomarker Focused, Phase 1 Trial of Oral WEE1 inhibitor, APR-1051

APR-1051 is a potent and selective, oral small molecule WEE1 inhibitor designed to potentially address therapeutic window limitations observed with earlier WEE1 programs. APR-1051 is being evaluated as a monotherapy in biomarker-defined cancers likely to respond to WEE1 inhibition. Among these, mutated PPP2R1A, FBXW7, HPV+ related and Cyclin E over expressing tumors represent a patient population with significant unmet medical need. These patient populations have a poor prognosis and limited effective treatment options.
On January 29, 2026, we announced the first unconfirmed partial response (uPR) observed in a patient enrolled in the ongoing Phase 1 ACESOT-1051 dose-escalation study: a patient with PPP2R1A-mutated uterine serous carcinoma, a form of endometrial cancer, treated at the 150 mg dose level of APR-1051. At the protocol-defined 8-week first imaging assessment, the patient achieved a 50% reduction in target lesion size per RECIST v1.1 criteria, along with a marked reduction in cancer antigen 125 (CA-125) levels, from 732 to 70 U/mL. CA-125 is a well-recognized tumor marker in endometrial cancer. On February 18, 2026, we announced the second uPR observed in a patient with PPP2R1A-mutated endometrial cancer, treated at the 220 mg dose level: at the first imaging assessment the patient achieved a 50% reduction in target lesion size, along with a marked decline in CA-125 from 362 at baseline to 47 U/mL, further supporting the anti-tumor activity of APR-1051.
Five other patients in ACESOT-1051 have achieved stable disease, including patients with HPV+ head and neck squamous cell carcinoma (HNSCC), colorectal and endometrial cancers with relevant genomic alternations.
APR-1051 has been safe and well tolerated with top two adverse events reported as Grade 1 or 2 were primary consistent of nausea and fatigue.
Dose escalation is ongoing, with patients currently being treated at Dose Level 8 (220 mg once daily) as the study continues to evaluate doses intendent to optimize therapeutic benefit while maintaining an acceptable safety profile. The company also plans to enroll additional patients to enrich for endometrial, colorectal and HPV+ tumors. A further update from ACESOT-1051 is expected in the second quarter of 2026.
For more information on ACESOT-1051, refer to ClinicalTrials.gov NCT06260514.
ABOYA-119: Ongoing Clinical Trial Evaluating ATR inhibitor, ATRN-119

ATRN-119 is a potent and highly selective first-in-class macrocyclic ATR inhibitor, designed and developed to be used in patients with tumors harboring mutations in DDR-related genes. Cancers with mutations in DDR-related genes represent a high unmet medical need. These patients often have a poor prognosis and currently lack effective therapeutics options.
During 4Q 2025 Aprea determined the recommended Phase 2 dose (RP2D) to be 1,100 mg for the once daily dosing for ATRN-119.
Following RP2D determination, Aprea has strategically paused further enrollment and has started an orderly wind-down of certain clinical trial site activities associated with the monotherapy arms as the Company explores ATRN-119 in potential combination approaches that may unlock greater clinical benefit. The Company is currently in discussions with leading academic institutions to evaluate ATRN-119 in combination with radiation in HPV+ head and neck cancer. Additional investigator-led studies evaluating ATRN-119 with immuno-oncology therapies and antibody-drug conjugates are also being explored.
For more information on ABOYA-119, please refer to clinicaltrials.gov NCT04905914.
Corporate

Aprea completed two private placements in December 2025 and January 2026, raising gross proceeds of approximately $3.1 million and $5.6 million, respectively, before deducting the placement agent’s fees and other estimated offering expenses.
In February 2026, the company appointed Eugene (Gene) Kennedy, MD, as Chief Medical Advisor. Dr. Kennedy is a highly accomplished physician scientist and biopharmaceutical executive with more than 20 years of experience spanning oncology clinical development, regulatory strategy, and senior corporate leadership across both public and private biotechnology companies.
Select Financial Results for the Fourth Quarter Ended December 31, 2025

As of December 31, 2025, Aprea reported cash and cash equivalents of $14.6 million compared to $22.8 million as of December 31, 2024. The Company believes its cash and cash equivalents as of December 31, 2025, together with the proceeds from the private placement completed in January 2026 will be sufficient to meet its currently projected operating expenses and capital expenditure requirements into the first quarter of 2027.
For the fourth quarter ended December 31, 2025, the Company reported an operating loss of $2.6 million, compared to an operating loss of $3.2 million in the fourth quarter of 2024.
Research and Development (R&D) expenses were $1.0 million for the quarter ended December 31, 2025, compared to $2.4 million for the fourth quarter of 2024. The decrease in R&D expenses was primarily related to lower expenses related to the ACESOT-1051 clinical trial to evaluate APR-1051 and the ABOYA-119 clinical trial to evaluate ATRN-119, which was voluntarily paused in October 2025, as well as a decrease in personnel costs primarily related to new hires and severance incurred during the fourth quarter of 2024.
General and Administrative (G&A) expenses were $1.6 million for the quarter ended December 31, 2025, compared to $1.1 million for the fourth quarter of 2024. The increase in G&A expenses was primarily related to personnel costs related to incentive compensation for our executive employees.
The Company reported a net loss of $2.5 million ($0.32 per basic share) on approximately 7.7 million weighted average common shares outstanding for the quarter ended December 31, 2025, compared to a net loss of $2.9 million ($0.49 per basic share) on approximately 6.0 million weighted average common shares outstanding for the comparable period in 2024.
Select Financial Results for the Year ended December 31, 2025

For the year ended December 31, 2025, the Company reported an operating loss of $13.2 million, compared to an operating loss of $14.3 million for the year ended December 31, 2024.
Grant revenues were $0.3 million for the year ended December 31, 2025, compared to $1.5 million for the year ended December 31, 2024.
R&D expenses were $7.0 million for the year ended December 31, 2025, compared to $9.4 million for the year ended December 31, 2024. The decrease in R&D expense was primarily related to lower expenses related to the ACESOT-1051 clinical trial to evaluate APR-1051 and the ABOYA-119 clinical trial to evaluate ATRN-119, which was voluntarily paused in October 2025, as well as a decrease in consulting expenses and personnel costs primarily related to new hires and severance incurred during the fourth quarter of 2024.
G&A expenses were $6.5 million for the year ended December 31, 2025, compared to $6.5 million for the year ended December 31, 2024.
The Company reported a net loss of $12.6 million ($1.93 per basic share) on approximately 6.5 million weighted-average common shares outstanding for the year ended December 31, 2025, compared to a net loss of $13.0 million ($2.35 per basic share) on approximately 5.5 million weighted average common shares outstanding for the comparable period in 2024.

(Press release, Aprea, MAR 16, 2026, View Source [SID1234663557])

On March 16, 2026 Agenus Inc. (Nasdaq: AGEN) reported financial results for the fourth quarter and full year ended December 31, 2025, highlighting progress for the botensilimab (BOT) plus balstilimab (BAL) immunotherapy program across patient access, clinical execution, and commercial readiness. BOT+BAL is a next-generation CTLA-4/PD-1 immunotherapy combination which activates both innate and adaptive immunity and has demonstrated immunotherapy benefit in tumors historically resistant to checkpoint inhibition.

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The BOT+BAL program entered global Phase 3 evaluation in refractory microsatellite-stable (MSS) metastatic colorectal cancer (mCRC), expanded through regulatory-authorized early access pathways in multiple countries and recognized initial revenue associated with treatment supplied through these programs while preparing for potential future regulatory submissions in the United States and Europe.

"BOT+BAL is beginning to stand out for the reasons that matter most; patients with few options are actively seeking access, physicians are gaining experience with the regimen, and the clinical foundation continues to strengthen," said Garo H. Armen, PhD, Chairman and CEO of Agenus. "When real-world interest and clinical relevance start to align, conviction builds. We believe BOT+BAL has the potential to become an important new immunotherapy franchise in CRC and across other difficult-to-treat cancers."

Key Business Highlights

Early Access Programs Expand Patient Reach and Build Physician ExperienceIn parallel with clinical development, Agenus has begun providing BOT+BAL through regulatory-authorized early access pathways in certain countries. These programs are designed to enable treatment for patients with serious diseases who have exhausted approved therapies while allowing physicians to gain experience with the investigational combination in real-world clinical settings.

France AAC Early Access Program:
France’s national Autorisation d’Accès Compassionnel (AAC) program provides hospital-based access to BOT+BAL for eligible patients with certain refractory cancers, with treatment reimbursed through the national health system. BOT+BAL was first authorized through the national AAC protocol in MSS mCRC with non-liver metastases (NLM) in September 2025 and was expanded to include platinum-resistant ovarian cancer (PROC) and soft-tissue sarcomas (STS) in January 2026. The expansion broadens reimbursed access across multiple difficult-to-treat tumors and adds to the clinical experience with BOT+BAL in France.

Global Paid Named-Patient Programs (NPP):
Outside France, BOT+BAL may be available in select countries through paid named-patient programs where permitted by local regulations and initiated at the request of treating physicians. Depending on local requirements, access may involve out-of-pocket payment and/or special insurance arrangements.

Initial BOT+BAL Revenues from Paid Early Access Programs

Across both access programs, Agenus has received over 200 inquiries from more than 30 countries. In the year ended December 31, 2025, Agenus recognized approximately $4.2 million in net revenue from the AAC and paid NPP programs, after consideration of estimated government rebates. Reimbursed treatment in France and paid named-patient activity in other markets are providing additional clinical experience and data ahead of potential approvals in major regions.

Clinical Data Reinforce BOT+BAL Potential

Clinical data generated in 2025 and early 2026 continued to support the development of BOT+BAL as a differentiated, next-generation CTLA-4/PD-1 immunotherapy combination for cancers historically resistant to checkpoint inhibition. The clinical dataset, now spanning more than 1,200 patients across nine tumor types, is most mature in CRC while continuing to expand across other immunologically "cold" tumors. Additional updates from ongoing company and investigator sponsored trials, including Phase 2 neoadjuvant CRC trials, are expected in 2026.

Key highlights from 2H 2025 and early 2026 include:

•
MSS metastatic colorectal cancer (ESMO-GI 2025):
42% two-year overall survival (OS) and median overall survival of approximately 21 months in patients with heavily pretreated MSS mCRC without active liver metastases treated with BOT+BAL; previously reported data from available standard of care therapies demonstrated a median OS of 10-14 months.
•
Pan-tumor activity (ESMO 2025):
In more than 400 heavily pretreated patients (median 3 prior lines of treatment) across more than nine tumor types, BOT+BAL demonstrated approximately 39% two-year OS, including activity in metastatic colorectal, ovarian, sarcoma, PD(L)-1 refractory NSCLC, and hepatocellular cancers.
•
AACR-IO biomarker analysis (AACR-IO 2026):
Integrated analysis of systemic inflammation and tumor immune features identified biologically distinct patient subgroups with differential survival outcomes and outperformed conventional biomarkers such as PD-L1 and tumor mutational burden.
These data support the differentiated immune-modulating mechanism of the BOT+BAL combination and reinforce its potential across immunologically "cold" tumors.

Phase 3 BATTMAN MSS mCRC Registrational Trial Initiated

The BATTMAN (CCTG CO.33, NCT07152821) trial is the first global Phase 3 study evaluating the next-generation CTLA-4-based immunotherapy combination in patients with refractory MSS/mismatch repair proficient (pMMR) mCRC who have exhausted other available options. MSS CRC represents approximately 95% of mCRC cases and has historically shown limited benefit from immunotherapy.

The international cooperative-group study is led by the Canadian Cancer Trials Group (CCTG), with participation from leading academic networks including CCTG, GI Cancer Trials in Australia, and France’s PRODIGE consortium.

The study is expected to enroll approximately 830 patients across more than 100 sites in Canada, France, Australia and New Zealand through leading cooperative group networks and is designed to support potential regulatory filings in the United States, Europe, Canada and other geographies.

Zydus Collaboration Strengthens Manufacturing, U.S. Infrastructure and Balance Sheet

In January 2026, Agenus closed its previously announced strategic collaboration with Zydus Lifesciences, providing strategic capital and dedicated biologics manufacturing capacity to support clinical development, authorized access programs and future commercial supply of BOT+BAL. Zydus paid $91 million of upfront capital at the close of the transaction, less certain adjustments. These adjustments include reimbursable expenses, other required closing payments, including approximately $5.8 million of transaction expenses and $7.5 million placed into a twelve-month escrow.

In March 2026, a $20 million contingent payment was triggered based on initial BOT+BAL work orders.

The collaboration strengthens Agenus’ balance sheet while securing dedicated U.S. manufacturing infrastructure for the next stage of clinical, regulatory and commercial expansion.

Financial Results

Fourth Quarter and Full Year 2025

Metric

Fourth Quarter 2025

Full Year 2025

Pre-commercial product revenue

$3.2 million

$4.2 million

Other revenue, including non-cash royalty revenue

$31.1 million

$110.0 million

Operating income (loss)

$14.4 million

$(20.2) million

Net loss

$(10.6) million

$(3.1) million

Pre-commercial product revenue represents initial contributions associated with treatment of investigational BOT+BAL supplied through early access programs, including France’s AAC program which commenced in the fourth quarter 2025.

2026 Strategic Priorities

•
Expand patient access through French ACC and global NPP early access pathways
•
Advance regulatory filings in the U.S. and the EU
•
Advance enrollment in the Phase 3 BATTMAN trial
•
Complete additional clinical and translational data in neoadjuvant CRC and other tumor types
•
Strengthen balance sheet and commercial readiness
Webcast and Conference Call Information

As part of Agenus’ newly launched webcast series, the Company will host a Stakeholder Briefing Webcast to review corporate activities. Additional details will be announced prior to the event.

About Agenus

Agenus is a leading immuno-oncology company targeting cancer with a comprehensive pipeline of immunological agents. The company was founded in 1994 with a mission to expand patient populations benefiting from cancer immunotherapy through combination approaches, using a broad repertoire of antibody therapeutics, adoptive cell therapies (through MiNK Therapeutics) and adjuvants. Agenus has robust end-to-end development capabilities, across commercial and clinical cGMP manufacturing facilities, research and discovery, and a global clinical operations footprint. Agenus is headquartered in Lexington, MA. For more information, visit www.agenusbio.com or @agenus_bio. Information that may be important to investors will be routinely posted on our website and social media channels.

About BATTMAN CO.33 Phase 3 Trial

Agenus, in collaboration with the Canadian Cancer Trials Group (CCTG), is initiating a global Phase 3 trial evaluating the immunotherapy combination of botensilimab (BOT) and balstilimab (BAL) versus best supportive care (BSC) in patients with refractory, unresectable microsatellite stable (MSS)/mismatch repair proficient (pMMR) colorectal cancer. This registrational study will be conducted as an international cooperative group trial, led by CCTG and supported by academic networks including GI Cancer Trials in Australia and PRODIGE (France), which comprises Unicancer, GERCOR, and FFCD. The trial will include more than 100 sites in Canada, France, Australia, and New Zealand.

Agenus’ Commitment to Patient Access

Until marketing authorization is granted, BOT+BAL is accessible only through clinical trials including the planned Phase 3 BATTMAN trial in refractory MSS colorectal cancer and authorized early access mechanisms where permitted and available under each country’s regulatory framework.

For eligible French patients treated in hospital under AAC meeting the pre-defined criteria, BOT+BAL is fully reimbursed by France’s national health system (Assurance Maladie). Reimbursement is structured as a single, upfront, course-based reimbursement per patient that covers the patient’s full course of therapy according to the national AAC protocol, rather than on a per-dose basis. Once a patient is authorized and treatment is initiated under the protocol, full course of treatment and all subsequent administrations are supplied without additional product charges. In line with AAC requirements, the maximum indemnity applicable to BOT+BAL is declared to the relevant French authorities.

Outside France, access may be available in select countries through paid named-patient programs, which may involve out-of-pocket payment and/or special insurance arrangements depending on local regulations and individual coverage decisions.

About Botensilimab (BOT)

Botensilimab (BOT) is a human Fc enhanced multifunctional anti-CTLA-4 antibody designed to boost both innate and adaptive anti-tumor immune responses. Its novel design leverages mechanisms of action to extend immunotherapy benefits to "cold" tumors which generally respond poorly to standard of care or are refractory to conventional PD-1/CTLA-4 therapies and investigational therapies. Botensilimab augments immune responses across a wide range of tumor types by priming and activating T cells, downregulating intratumoral regulatory T cells, activating myeloid cells and inducing long-term memory responses.

Approximately 1,200 patients have been treated with botensilimab and/or balstilimab in phase 1 and phase 2 clinical trials. Botensilimab alone, or in combination with Agenus’ investigational PD-1 antibody, balstilimab, has shown clinical responses across nine metastatic, late-line cancers. For more information about botensilimab trials, visit www.clinicaltrials.gov.

About Balstilimab (BAL)

Balstilimab is a novel, fully human monoclonal immunoglobulin G4 (IgG4) designed to block PD-1 (programmed cell death protein 1) from interacting with its ligands PD-L1 and PD-L2. It has been evaluated in more than 900 patients to date and has demonstrated clinical activity and a favorable tolerability profile in several tumor types.

(Press release, Agenus, MAR 16, 2026, View Source [SID1234663556])

On March 16, 2026 Telix Pharmaceuticals Limited (ASX: TLX, NASDAQ: TLX, "Telix") reported the resubmission of a New Drug Application (NDA) to the United States (U.S.) Food and Drug Administration (FDA) for TLX101-Px, (Pixclara1, Floretyrosine F 18 or 18F-FET), an investigational PET2 imaging agent for the characterization of recurrent or progressive glioma (brain cancer) from treatment related changes in both adult and pediatric patients.

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Telix has resubmitted the NDA with the additional data requested by the FDA. The Company believes, based on the Type A meeting and ongoing consultation with the FDA, that the additional data and statistical analysis, along with the primary data set provided in the original submission, appropriately addresses the Complete Response Letter3.

Given the potential to address significant unmet medical need, TLX101-Px has been granted Orphan Drug4 and Fast Track5 designations by the FDA. PET imaging with 18F-FET is already included in international clinical practice guidelines for the imaging of gliomas6, however there is currently no FDA-approved targeted amino acid PET agent for adult and pediatric brain cancer imaging commercially available in the U.S.

Dr. David N. Cade, Telix Group Chief Medical Officer, said, "We appreciate the FDA’s recognition of the critical unmet need to improve the diagnosis and management of glioma, particularly in the post-treatment setting. Our resubmission is supported by an extensive and compelling data set – particularly so for an orphan indication. We are grateful to our global clinical collaborators, who share our commitment to ensuring patients in the U.S. can benefit from this important patient management tool."

Maggie Haynes, Executive Director, Head for the Cure Foundation, added: "Our community is encouraged by the FDA’s ongoing engagement and guidance to the sponsor and support for the Expanded Access Program for TLX101-Px. We are hopeful of an expedited review, so this important and proven imaging option can become available to those who urgently need it."

About TLX101-Px

TLX101-Px is a PET imaging agent, which has been granted fast track and orphan drug designations by the FDA as an imaging agent for the characterization of recurrent or progressive glioma from treatment related changes. TLX101-Px targets membrane transport proteins known as LAT1 and LAT27. This enables TLX101-Px to be potentially utilized as a companion diagnostic agent to TLX101-Tx (iodofalan 131I), Telix’s LAT1-targeting glioblastoma (GBM) therapy candidate, currently under investigation in the pivotal IPAX-BrIGHT study8.

About gliomas in the U.S.

Gliomas are very diffusely infiltrative tumors that affect the surrounding brain tissue. They are the most common form of central nervous system (CNS) neoplasm that originates from glial cells, accounting for approximately 30% of all brain and CNS tumors and 80% of all malignant brain tumors9. In the U.S., there are six cases of gliomas diagnosed per 100,000 people every year10. GBM is a high-grade glioma and the most common and aggressive form of primary brain cancer, with approximately 22,000 new cases diagnosed annually in the U.S.11. The mainstay of treatment for GBM comprises surgical resection, followed by combined radiotherapy and chemotherapy. Despite such treatment, recurrence occurs in almost all patients12, with an expected survival duration of 12-15 months from diagnosis.

(Press release, Telix Pharmaceuticals, MAR 16, 2026, View Source [SID1234663549])

On March 15, 2026 Akeso, Inc. (9926.HK) ("Akeso" or the "Company") reported that its proprietary first-in-class trispecific antibody, AK150 (ILT2/ILT4/CSF1R), has received Investigational New Drug (IND) clearance from the National Medical Products Administration (NMPA) for clinical trials in patients with advanced solid tumors.

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AK150 is currently the only ILT2/ILT4/CSF1R trispecific antibody under development globally and is also Akeso’s first trispecific molecule to enter the clinical stage. Engineered via Akeso’s leading AI-driven drug discovery platform and its proprietary Tetrabody technology, AK150 stands as a global first-in-class innovation, once again demonstrating the company’s deep expertise and strong R&D capabilities in the field of multispecific antibody therapeutics.

ILT2, ILT4, and CSF1R exhibit high expression levels in various solid tumors, particularly prominent in tumor types with significant immunosuppressive microenvironments, including non-small cell lung cancer, hepatocellular carcinoma, pancreatic cancer, and some refractory breast cancers. Although current single- or dual-target therapies against macrophage related targets (such as those targeting ILT2, ILT4, or CSF1R) have shown some potential globally, they still fall short of fully breaking the immunosuppressive network of the tumor microenvironment. This underscores an urgent need for multi-target synergistic innovative therapies capable of multi-dimensional immune remodeling to improve anti-tumor efficacy—especially to overcome the clinical challenge of traditional immunotherapy’s insensitivity to "cold tumors".

By simultaneously targeting ILT2, ILT4, and CSF1R, AK150 enables synergistic anti-tumor activity through coordinated modulation of both innate and adaptive immune systems. It holds high therapeutic potential not only for hot tumors but also for converting "cold tumors" into "hot tumors", thereby fundamentally improving tumor responsiveness to immunotherapy.

CSF1R, ILT2, and ILT4 each play important immunomodulatory roles in the tumor microenvironment, together constructing a complex immunosuppressive network. The synergistic blockade of these three targets can relieve immune suppression at multiple levels. AK150 depletes immunosuppressive myeloid cells by CSF1R blockade, while simultaneously releasing the "molecular brakes" on remaining myeloid populations by ILT2 and ILT4 blockade. Meanwhile, ILT2 blockade by AK150 also has the potential to activate CD8+ T cells and Natural Killer (NK) cells, enhancing the anti-tumor immune response. This innovative design holds promise for addressing key challenges in solid tumor drug development.

About AK150
AK150 is a proprietary, humanized anti-CSF1R, ILT2, and ILT4 trispecific antibody developed by Akeso. By binding to CSF1R, AK150 blocks the interaction between CSF1R and CSF1/IL-34, thereby inhibiting CSF1R-dependent survival of myeloid cells, eliminating M2-like TAMs; By binding to ILT2/ILT4, AK150 blocks the interaction between ILT2/ILT4 and HLA-A/B/C/E/G, relieving immunosuppression of myeloid cells, and restoring the activity and function of NK cells and CD8+ T cells. Therefore, by synergistically blockade CSF1R/ILT2/ILT4, AK150 achieves multi-pathway blockade of both innate and adaptive immunity, enabling multi-dimensional relief of immunosuppression in the tumor microenvironment and overcoming the limitations of poor clinical efficacy by single-target drugs. . Preclinical animal models have demonstrated that AK150 exhibits dose-dependent tumor inhibition across all tested dosage groups.

(Press release, Akeso Biopharma, MAR 15, 2026, View Source [SID1234663548])

On March 13, 2026 Shanghai Junshi Biosciences Co., Ltd ("Junshi Biosciences," HKEX: 1877; SSE: 688180), a leading innovation-driven biopharmaceutical company dedicated to the discovery, development, and commercialization of novel therapies, reported its financial results for the full year of 2025 and provided corporate updates.

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FINANCIAL HIGHLIGHTS

Total revenue of Junshi Biosciences was approximately RMB2,498 million in 2025, representing an increase of approximately 28% compared to 2024, which was mainly due to the increase in revenue from sales of pharmaceutical products, in particular the domestic sales revenue of the company’s core product, toripalimab, was approximately RMB2,068 million, representing an increase of approximately 38% compared to 2024.
Total research and development ("R&D") expenses of the company were approximately RMB1,384 million in 2025, representing an increase of approximately 9% compared to 2024. The increase in R&D expenses was mainly due to the company’s focus on more competitive and innovative R&D pipelines and accelerated clinical development in 2025.
Net cash inflow from financing activities was approximately RMB2,232 million, which fully covered the cash outflows in operating and investing activities, leading to an increase in bank balances and cash. A successful placing of new H shares on 20 June 2025 generated a net cash inflow of approximately RMB940 million for the company.
As of the end of 2025, the company’s aggregate balance of bank balances and cash and financial products was approximately RMB3,195 million, providing a relatively sufficient cash position to support the company’s development.
BUSINESS HIGHLIGHTS

During 2025, our commitment to addressing "unmet medical needs" has driven original, innovative and breakthrough progress in the discovery, R&D and commercialization of innovative therapies and drugs through accelerating international development. Here are the notable achievements and milestones:

Advancements in the pipeline: Junshi Biosciences’ innovative R&D field has expanded from monoclonal antibodies to the research and development of various drug modalities, including small molecule drugs, polypeptide drugs, antibody drug conjugates (ADC), bi-specific or multi-specific antibodies, bispecific antibody drug conjugates, fusion protein, nucleic acid drugs and vaccines, as well as the exploration of next-generation innovative therapies, including those for cancer and autoimmune diseases. A total of four drugs have been commercialized, a number of products are undergoing phase 3 clinical studies or in the stage of marketing application, and various innovative drugs that are competitive in the international market are undergoing accelerated clinical trials.

In January 2025, the indication of toripalimab for the treatment of unresectable or metastatic melanoma after failure of standard systemic therapy was approved by the National Medical Products Administration of China (the "NMPA") for conversion from conditional approval to regular approval.
In January 2025, the investigational new drug ("IND") application for JS212 [a recombinant humanized epidermal growth factor receptor ("EGFR") and human epidermal growth factor receptor 3 ("HER3") bispecific ADC] was accepted by the NMPA. It was approved by the NMPA in March 2025. The IND application of JS212 multi-cohort combined drug application was approved by the NMPA in November 2025. In December 2025, the IND application for JS212 for the treatment of advanced solid tumors was approved by the U.S. Food and Drug Administration ("FDA").
In January 2025, the indication of VV116/JT001 (MINDEWEI) for the treatment of adult patients with mild to moderate coronavirus disease 2019 ("COVID-19") was approved by the NMPA for conversion from conditional approval to regular approval.
In January 2025, the New Chemical Entity ("NCE") application for toripalimab in combination with cisplatin and gemcitabine, for the first-line treatment of adults with metastatic or recurrent, locally advanced nasopharyngeal carcinoma ("NPC") and toripalimab, as a single agent, for the treatment of adults with recurrent unresectable or metastatic NPC with disease progression on or after a platinum-containing chemotherapy was approved by the Therapeutic Goods Administration of the Australian Government Department of Health and Aged Care (the "TGA"). Toripalimab became the first immuno-onocology treatment for NPC in Australia.
In February 2025, the IND application for JS213 (a PD-1 and interleukin-2 ("IL-2") bifunctional antibody fusion protein) was approved by the NMPA.
In March 2025, the supplemental new drug application (the "sNDA") for toripalimab in combination with bevacizumab for the first-line treatment for patients with unresectable or metastatic hepatocellular carcinoma ("HCC") was approved by the NMPA.
In March 2025, the new drug application (the "NDA") for toripalimab in combination with cisplatin and gemcitabine for the first-line treatment of adult patients with recurrent, not amenable to surgery or radiotherapy, or metastatic NPC was approved by the Singapore Health Sciences Authority (the "HSA"). Toripalimab became the first approved immuno-oncology treatment for NPC in Singapore.
In April 2025, the sNDA for toripalimab for the first-line treatment of unresectable or metastatic melanoma was approved by the NMPA. This is the 12th indication of toripalimab approved in Chinese Mainland.
In May 2025, the two sNDAs for the ongericimab injection (a recombinant humanized anti-PCSK9 monoclonal antibody injection, trade name: JUNSHIDA) for: 1) adult patients with heterozygous familial hypercholesterolemia ("HeFH"); 2) alone or in combination with ezetimibe, in adult patients with non-familial hypercholesterolemia and mixed dyslipidemia who are statin-intolerant or statins contraindicated, were approved by the NMPA. Ongericimab became the first domestic PCSK9-targeted drug approved for statin-intolerant patients.
In June 2025, the IND application for the JT118 injection ("JT118") was accepted. It was approved by the NMPA in September 2025. JT118 is a "two-in-one" recombinant protein vaccine composed of a tandem fusion of monkeypox virus antigens A35 (an extracellular enveloped virus antigen) and M1 (an intracellular mature virus antigen), and is intended mainly for the prevention of monkeypox virus infection.
In June 2025, the indications of toripalimab for the first-line treatment of NPC and the first-line treatment of esophageal squamous cell carcinoma ("ESCC") were officially approved for marketing in the United Arab Emirates (the "UAE") and Kuwait.
In August 2025, the sNDA for toripalimab in combination with disitamab vedotin as the treatment of HER2-expressing (HER2 expression is defined as HER2 immunohistochemistry results of 1+, 2+, or 3+) locally advanced or metastatic UC was accepted by the NMPA.
In September 2025 and October 2025, the two indications for toripalimab in combination with cisplatin and gemcitabine for the first-line treatment of adults with metastatic or recurrent, locally advanced NPC, and toripalimab, as a single agent, for the treatment of adults with recurrent, unresectable or metastatic NPC with disease progression on or after a platinum-containing chemotherapy were approved for marketing in Pakistan and Canada, respectively.
In October 2025, the IND application for an open-label, two-arm, randomized, active-controlled, phase 2/3 clinical study comparing JS207 (recombinant humanized anti-PD-1/VEGF bispecific antibody), to nivolumab for the neoadjuvant treatment of patients with stage 2/3, resectable, actionable genomic aberration (AGA)-negative, non-small cell lung cancer ("NSCLC") was approved by the FDA.
In November 2025, a new indication of toripalimab in combination with chemotherapy as first-line treatment of ESCC was approved in Hong Kong SAR, China.
In November 2025, the multi-center, open-label, randomized controlled phase 3 clinical study comparing JS001sc (toripalimab injection for subcutaneous use) to toripalimab in combination with chemotherapy for the first-line treatment of recurrent or metastatic non-squamous NSCLC met its primary endpoints.
In December 2025, the NDA for JS005 (roconkibart injection, a recombinant humanized anti-IL-17A monoclonal antibody injection), for the treatment of adult patients with moderate to severe plaque psoriasis who are candidates for systemic therapy or phototherapy was accepted.
In December 2025, toripalimab, with two new indications, and JUNSHIDA was successfully included in Category B of the National Drug List for Basic Medical Insurance, Maternity Insurance and Work-Related Injury Insurance (Year 2025) (the "NRDL").
In December 2025, the indications of toripalimab for the first-line treatment of NPC and the first-line treatment of ESCC were approved for marketing in Bahrain.
Update on external collaborations

In January 2025, TopAlliance Biosciences Inc. ("TopAlliance"), a wholly-owned subsidiary of the company, entered into a distribution and marketing agreement with LEO Pharma A/S ("LEO Pharma"). TopAlliance will grant LEO Pharma the exclusive right to store, distribute, promote, market and sell toripalimab in all current member states and any future member states of the European Union (the "EU") and the European Economic Area (the "EEA"), Switzerland as well as the United Kingdom (the "UK") (the "Territory"). LEO Pharma shall pay TopAlliance an upfront payment of EUR15 million, milestone payment(s) for any subsequent approved indication(s) for toripalimab in the Territory, and a revenue share of a double-digit percentage on the net sales of toripalimab throughout the Territory.
Update on business operations

In June 2025, Suzhou Union Biopharm Biosciences Co., Ltd. ("Suzhou Union"), a wholly-owned subsidiary of the company, underwent and passed an unannounced inspection (i.e., an inspection conducted without prior notification during routine operations) in respect of Current Good Manufacturing Practice ("CGMP") by the FDA.
In June 2025, the company completed the placing of new H shares under general mandate (the "Placing"), pursuant to which an aggregate of 41,000,000 H shares (the "Placing Shares") were successfully allotted and issued at HK$25.35 per H share. The net proceeds (after deduction of commissions and estimated expenses) amounted to approximately HK$1,026 million, which shall be used for innovative drug development and general corporate purposes such as replenishment of working capital.
In September 2025, the 2025 A Share Option Incentive Scheme and the 2025 H Share Option Incentive Scheme and related resolutions were considered and approved at a general meeting held by the company.

(Press release, Shanghai Junshi Bioscience, MAR 13, 2026, View Source [SID1234663542])