On March 30, 2026 Aktis Oncology, Inc. (NASDAQ:AKTS) (the "Company"), a clinical-stage oncology company focused on expanding the breakthrough potential of targeted radiopharmaceuticals to large populations, including those not addressed by existing platform technologies, reported the U.S. Food and Drug Administration (FDA) cleared the Investigational New Drug (IND) applications for the Company to proceed to a Phase 1b clinical trial with AKY-25191. AKY-2519 is a miniprotein radioconjugate targeting B7-H3, which is expressed in several solid tumor types including prostate and lung cancers, and is the second clinical stage miniprotein radioconjugate discovered using Aktis’ proprietary platform. The Company’s lead miniprotein radioconjugate, AKY-1189, targeting Nectin-4, is currently enrolling patients in a Phase 1b clinical study. Aktis’ miniprotein radioconjugates are designed to selectively deliver actinium-225 (225Ac), a highly potent alpha-emitting radioisotope, to target-expressing tumors. The Company also provided business updates and reported financial results for the year ended December 31, 2025.

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"Aktis was founded to improve outcomes for cancer patients by pioneering a new class of targeted radiopharmaceuticals for prevalent tumor types that have historically been beyond the reach of this modality," said Matthew Roden, Ph.D., President and Chief Executive Officer of Aktis Oncology. "We continue to make significant progress on all fronts of our plan, including advancing the enrollment of our Phase 1b clinical trial of AKY-1189 in patients with Nectin-4 expressing tumors, which was granted FDA Fast Track designation in February, as well as the recent clearance of our IND applications for AKY-2519. We are excited to accelerate the AKY-2519 program to patients in need of improved treatment options, and now expect to commence a Phase 1b trial of AKY-2519 in mid-2026. This momentum, together with our proprietary miniprotein radioconjugate platform, supply chain infrastructure, and strong cash position, strengthens our leadership in targeted radiopharmaceuticals."

Dr. Roden continued, "AKY-1189 and AKY-2519 each represent significant patient impact opportunities, with the potential to address multiple indications across various tumor types. We are working urgently to generate the clinical data necessary to support registrational trials for both programs."

Business updates and anticipated key milestones

Pipeline
AKY-1189, a novel miniprotein radioconjugate designed to selectively deliver 225Ac to Nectin-4 expressing tumors, is in an ongoing Phase 1b clinical trial enrolling patients with locally advanced or metastatic urothelial cancer (mUC), breast cancer, non-small cell lung cancer, colorectal cancer, cervical cancer, and head and neck cancer.

In February 2026, the FDA granted Fast Track designation for AKY-1189 for the treatment of adult patients with locally advanced or mUC who have progressed on or after prior systemic therapies.

AKY-2519, a miniprotein radioconjugate designed to selectively deliver 225Ac to B7-H3 expressing tumors, including prostate, lung and other solid tumors, is in an ongoing imaging and dosimetry clinical assessment of AKY-2519 to enable initial understanding of biodistribution and uptake in tumors and normal tissues.

In March 2026, the FDA cleared the IND applications for [64Cu]Cu-AKY-2519 (imaging) and [225Ac]Ac-AKY-2519 (therapeutic use) to proceed to a Phase 1b clinical trial.

Corporate
On January 8, 2026, the Company priced an initial public offering (IPO) of its common stock, raising $365.4M gross proceeds, before underwriting discounts and other offering-related expenses.

Anticipated key milestones for the next 12 months

AKY-1189: Preliminary data from Part 1 of the ongoing Phase 1b clinical trial are expected in the first quarter of 2027.
AKY-2519:
Results from clinical imaging and dosimetry assessment of AKY-2519 in patients with various solid tumors are expected in mid-2026.
Phase 1b clinical trial is expected to commence in mid-2026. The Company plans to provide further details on the overall clinical development strategy of AKY-2519 at that time.
Early pipeline: Two programs are tracking toward development candidate nomination and commencement of IND-enabling activities in the first quarter of 2027.
Corporate: In-house Good Manufacturing Practices (GMP) facility is expected to be operational in the second half of 2026 as part of the Company’s hybrid manufacturing strategy to expand capabilities and support clinical supply demand.
2025 financial results

Cash position: Cash, cash equivalents and marketable securities were $226.8 million as of December 31, 2025, compared to $297.2 million as of December 31, 2024. Subsequent to December 31, 2025, the Company completed its IPO, generating net proceeds of approximately $335.3 million, after underwriting discounts, commissions and offering-related expenses. As a result, the Company’s pro forma as adjusted cash position as of year-end 2025 was $562.1 million, reflecting cash, cash equivalents and marketable securities as of December 31, 2025, plus net proceeds from the January 2026 IPO. The Company believes that the pro forma as adjusted cash position will fund its operations into 2029.
Collaboration revenue: Collaboration revenue was $6.5 million for the year ended December 31, 2025, compared to $1.5 million for the year ended December 31, 2024. The increase was attributable to revenue recognized under the Company’s collaboration with Eli Lilly and Company, which was entered into in May 2024. In 2024, revenue recognition began in the fourth quarter, whereas a full year of revenue was recognized in 2025.
R&D expenses: Research and development expenses were $67.5 million for the year ended December 31, 2025, compared to $41.0 million for the year ended December 31, 2024. The increase was primarily driven by higher headcount, and increased program expenses to support the advancement of AKY-1189 in a Phase 1b clinical trial and AKY-2519 IND-enabling studies and clinical imaging and dosimetry assessment.
G&A expenses: General and administrative expenses were $13.7 million for the year ended December 31, 2025, compared to $12.6 million for the year ended December 31, 2024. The increase was primarily due to higher headcount to support the Company’s growing business.
Net loss: Net loss was $63.7 million for the year ended December 31, 2025, compared to $44.0 million for the year ended December 31, 2024. The increase in net loss was primarily driven by the increase in R&D expenses described above.

(Press release, Aktis Oncology, MAR 30, 2026, View Source [SID1234664041])

On March 30, 2026 RenovoRx, Inc. ("RenovoRx" or the "Company") (Nasdaq: RNXT), a life-sciences company developing innovative targeted oncology therapies and commercializing RenovoCath, a patented, FDA-cleared drug-delivery device, reported its financial results for the full year and fourth quarter ended December 31, 2025, and is providing a business update to shareholders.

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Shaun Bagai, Chief Executive Officer of RenovoRx, commented, "2025 marked a key year as it was our first full year of RenovoCath commercialization, generating over $1 million in revenue and reflecting strong initial physician adoption and demand in a handful of active commercial cancer centers. We also learned many valuable lessons to finalize our go-to-market strategy that we are implementing and building out a team to drive commercial growth in 2026 and beyond."

Mr. Bagai continued, "We entered 2025 having just taken our initial steps towards commercialization, with no dedicated sales team and limited approved commercial cancer centers. We exited the year with a strong understanding of the market and a clear strategy supported by a focused and agile sales and marketing team. Our network of active commercial cancer center clients continues to grow, resulting in meaningful revenue generation. While we are still relatively early in the game, we believe we are beginning to unlock the broader commercial potential for RenovoCath as a stand-alone device. Adoption across U.S. cancer centers continues to build, driven by new and repeat orders, growing physician familiarity, and increasing procedural utilization. As of February 27, 2026, 12 U.S. cancer centers are utilizing RenovoCath, and 21 additional centers are evaluating the device, have completed evaluation, or are preparing for activation. These 33 centers represent a tripling of our near-term pipeline compared to the first quarter of 2025."

"Importantly, we established our commercial infrastructure in the fourth quarter of 2025, positioning us to scale in 2026 with a targeted focus on high-volume cancer centers. On top of this, we have significantly strengthened our balance sheet with $10 million in gross proceeds (net proceeds of $9.2 million) from recent financing led by new and existing institutional investors including insider participation, giving us $13 million in cash on hand as of today. We strongly believe we now have the funding, business plan, leadership, and infrastructure to propel execution across all of our activities as we drive towards important milestones, including breakeven operations and trial data."

"Simultaneously, we are advancing our pivotal Phase III TIGeR-PaC trial, which remains on track for full enrollment in the near term and with final results anticipated next year. We recently announced the achievement of a milestone by randomizing our 100th patient in the trial. As of March 24, 2026, 104 patients have been randomized with 72 events (deaths) observed. Our target of full enrollment by the middle of this year would ensure a minimum of 114 patients will be randomized. Our study protocol requires us to advance a minimum of 114 patients to randomization, so we are really in the home stretch of this trial. Moreover, our goal is to transition the 17 cancer centers that have used RenovoCath as part of the TIGeR-PaC trial to commercial customers for RenovoCath in the second half of 2026 after completion of TIGeR-PaC enrollment. Select TIGeR-PaC cancer centers have already begun using the TAMP (Trans-Arterial Micro-Perfusion) therapy platform, enabled by the RenovoCath device, for targeted drug-delivery in the treatment of patients diagnosed with solid tumors, giving us even more optimism for the expansion of our revenue potential," concluded Mr. Bagai.

RenovoCath Commercialization Update

RenovoRx achieved key milestones in the commercial launch of RenovoCath in 2025, its first full year of generating revenue. For the year ending December 31, 2025, the Company generated $1.1 million in revenue from RenovoCath sales, driven by both new cancer centers adopting the device and repeat orders from existing customers. This early commercial traction reflects increasing physician interest in targeted intra-arterial drug-delivery and shows that RenovoCath is becoming widely used within clinical workflows at leading, high-volume cancer centers. The Company also learned valuable lessons about cycle trends, activation timelines, customer preferences, and other commercial data which it expects to apply as it seeks to grow RenovoCath revenues in 2026 and beyond.

Adoption continued to expand across the United States, with 12 cancer centers actively utilizing RenovoCath as of early 2026 and a growing pipeline of additional centers evaluating the device, having completed evaluation or are preparing for activation. The Company is also observing repeat ordering patterns and increased procedural utilization among early adopters, reinforcing confidence in physician satisfaction and the potential for recurring revenue. RenovoRx believes these trends support the long-term commercial opportunity for RenovoCath as both a stand-alone device and a foundational platform for future drug-device combination therapies.

RenovoRx continues to estimate that the initial total addressable market (TAM) for RenovoCath as a stand-alone device represents an approximately $400 million peak annual U.S. sales opportunity, and ultimately a multi-billion-dollar potential as the platform expands into additional solid tumor indications.

Clinical Research and Scientific Programs Update

RenovoRx continues to advance its ongoing Phase III TIGeR-PaC clinical trial evaluating intra-arterial delivery of gemcitabine (IAG) via the RenovoCath device for the treatment of locally advanced pancreatic cancer (LAPC). The current protocol and statistical analysis plan for the TIGeR-PaC trial requires 114 randomized patients, with 86 events (deaths) necessary to complete the final analysis. As of March 24, 2026, 104 patients have been randomized and 72 events have occurred. RenovoRx anticipates completion of enrollment by the middle of 2026, ensuring a minimum of 114 patients will be randomized.

During 2025, the TIGeR-PaC trial reached a key milestone with the completion of the second pre-planned interim analysis. Following its review, the independent Data Monitoring Committee for the trial recommended that the study continue without modification, which the Company believes is an expression of confidence in the potential for a positive outcome in the trial overall. TIGeR-PaC remains the cornerstone of RenovoRx’s clinical development strategy and is designed to evaluate overall survival benefit with the potential to support a future New Drug Application submission, if successful.

The Company also continues to advance broader clinical programs by generating new data through post-marketing registry studies in solid tumors and continued support of investigator-initiated trials (IIT) in borderline resectable and metastatic pancreatic cancer, along with exploring physician interest in other areas. Registry and IIT studies achieve cost neutrality as capital-efficient studies providing meaningful data that may further broaden the application for the TAMP (Trans-Arterial Micro-Perfusion) therapy platform which is enabled by RenovoCath.

Fourth Quarter 2025 and Subsequent Key Highlights

During the fourth quarter of 2025, RenovoRx completed the initial buildout of its commercial infrastructure, including the launch of its sales and marketing team, and continued advancing its commercialization strategy.

RenovoRx strengthened its executive leadership team in February 2026 to support the commercial growth of RenovoCath with the appointment of Mark Voll as Chief Financial Officer. Mr. Voll brings more than 30 years of financial leadership experience with a proven track record of guiding high-growth public companies through periods of commercial buildout and strategic development. He has served as Chief Financial Officer for multiple publicly traded technology companies where he successfully led initiatives that scaled operations into high-growth businesses.

In February 2026, the Company established the RenovoCath Medical Advisory Board (MAB) to provide strategic clinical guidance in advancing the TAMP therapy platform across indications of high unmet medical needs. The MAB includes leading interventional oncology experts: Nadine Abi-Jaoudeh, MD of UCI Health, Mustafa Al-Roubaie, MD of Moffitt Cancer Center, Khashayar Farsad, MD, PhD of Oregon Health and Science University, Ripal Gandhi, MD of Baptist Health South Florida, Paula Marie Novelli, MD of University of Pittsburgh Medical Center and Jonathan Kessler, MD of City of Hope Comprehensive Cancer Center.

On March 20, 2026, RenovoRx closed on an oversubscribed private placement of common stock and revenue milestone warrants resulting in gross proceeds of $10 million to RenovoRx, before deducting placement agent fees and offering expenses with net proceeds of $9.2 million. The financing was led by new and existing high-quality institutional investors, and the Company intends to use the net proceeds from the private placement for working capital and general corporate purposes.

The net proceeds of the private placement provide RenovoRx with a total of approximately $13 million cash and cash equivalents in hand to drive its business towards the expected achievement of important milestones in 2026 and 2027.

Financial Highlights for the Full Year Ended December 31, 2025

Revenue for the year ended December 31, 2025, was $1.1 million, compared to $43,000 for the year ended December 31, 2024. Fiscal year 2025 marked our first full year of revenue of RenovoCath and early customer adoption across U.S. cancer centers.

Cash and cash equivalents were approximately $7.0 million as of December 31, 2025. Subsequent to year end, on March 20, 2026, the Company strengthened its balance sheet and closed a private placement offering with gross proceeds of $10 million and net proceeds of $9.2 million.

Research and development expenses were approximately $6.3 million for the year ended December 31, 2025, compared to approximately $6.0 million for the same period last year. The increase was primarily attributable to continued investment in the Company’s ongoing Phase III TIGeR-PaC clinical trial, as well as development activities related to the next generation of the RenovoCath device.

Selling, general, and administrative expenses were approximately $7.0 million for the year ended December 31, 2025, compared to approximately $5.0 million for the year ended December 31, 2024. The increase was primarily driven by the buildout of the Company’s commercial infrastructure, including sales and marketing capabilities, as well as higher professional services and personnel-related costs.

Net loss for the year ended December 31, 2025, was approximately $11.2 million, compared to approximately $8.8 million for the prior year.

Shares of common stock outstanding as of March 23, 2026 was 45,052,706.

Conference Call Details

Event: RenovoRx Fourth Quarter & Full Year 2025 Financial Results and Business Highlights Call
Date: Monday, March 30, 2026
Time: 4:30 p.m. ET
Live Call: 1-877-407-4018 (U.S. Toll Free) or 1-201-689-8471 (International)
Webcast: View Source

For interested individuals unable to join the conference call, a link to the recording will be available on RenovoRx’s Investor Relations website, and a dial-in replay will be available until April 13, 2026 and can be accessed by dialing 1-844-512-2921 (U.S. Toll Free) or 1-412-317-6671 (International) and entering replay pin number 13758677.

A question and answer session will occur at the end of the call, and a link to the recording of this presentation will be available on RenovoRx’s Investor Relations website after the event.

(Press release, Renovorx, MAR 30, 2026, View Source [SID1234664040])

On March 30, 2026 Certis Oncology, an AI-enabled translational science company, reported the launch of Certis Oncology Intelligence, an integrated platform designed to generate data-driven insights into therapeutic response by combining predictive modeling, agentic AI-enabled biological data exploration, and functional validation in clinically relevant cancer models.

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Certis Oncology Intelligence represents a new approach to translational research—one that connects computational prediction with real-world biological evidence in a continuous learning system.

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Certis Oncology Intelligence represents a new approach to translational research—one that connects computational prediction with real-world biological evidence in a continuous learning system.

"One of the central challenges in oncology drug development is that we generate enormous amounts of data, but struggle to translate that into reliable predictions of therapeutic response," said Peter Ellman, Certis President and CEO. "Certis Oncology Intelligence was built to close that gap—linking prediction, biological context, and experimental validation into a system that continuously learns and improves over time."

A Three-Layer Translational Intelligence System

Certis Oncology Intelligence is a secure, multi-tenant, closed loop system that integrates three data layers:

1.

Predictive Intelligence Layer— CertisAI

A patented, generalized drug-response foundation model trained to internalize relationships between chemical structure, tumor biology, and therapeutic response, CertisAI enables zero-shot prediction of how cancers are likely to respond to therapeutic agents, including novel compounds, even in the absence of prior experimental data.

This predictive layer can be fine-tuned using sponsor training data, producing powerful, custom computational models uniquely aware of each company’s novel chemical space.

2.

Exploration Layer — Agentic Biospecimen Management

Agentic biospecimen management enables researchers to dynamically query and analyze biological specimens together with their associated molecular and experimental datasets—offering a secure in silico environment in which to rapidly test hypotheses.

Within the Oncology Intelligence platform, licensors can integrate their own proprietary datasets—molecular profiles, drug-response screening results, target binding data, and other translational information accumulated across programs over many years.

By cross-referencing a company’s proprietary datasets with the platform’s foundational training data, the system can surface previously hidden relationships within each sponsor’s institutional knowledge base—generating new hypotheses, translational insights, and opportunities to advance or reprioritize therapeutic programs.

3.

Validation Layer—Functional Biological Evidence

A key differentiator of this platform is its ability to learn from continuous biological validation using experimental data generated either by Certis or by its collaborators. Validation data may include results from studies performed in human-concordant cancer models such as patient-derived xenografts (PDX), as well as in vitro assays, organoid models, or clinical trials.

Importantly, results from experimental studies are seamlessly fed back into the system as additional training data, continually improving predictive performance over time.

Unlocking the Value of Translational Data

The platform is designed to help pharmaceutical and biotechnology companies:

Integrate diverse datasets across programs and time
Identify biologically meaningful drivers of therapeutic response
Generate and test hypotheses more efficiently
Improve confidence in translational and clinical decision-making
By enabling organizations to extract new insights from existing data while continuously generating new evidence, Certis Oncology Intelligence offers a scalable foundation for more predictive and data-driven oncology development.

Availability

Certis Oncology Intelligence is available to pharmaceutical and biotechnology partners through licensing and collaborative engagements.

(Press release, Certis Oncology Solutions, MAR 30, 2026, View Source [SID1234664039])

On March 30, 2026 IDEAYA Biosciences, Inc. (NASDAQ: IDYA), a precision medicine oncology company committed to the discovery and development of targeted therapeutics, reported first-patient-in for a Phase 1 clinical trial combination study to evaluate IDE849, a potential first-in-class delta-like ligand 3 (DLL3)-targeting Topo-I-payload antibody drug conjugate (ADC) program, and IDE161, a potential first-in-class poly(ADP-ribose) glycohydrolase (PARG) inhibitor. The Phase 1 combination study will be evaluated in DLL3 upregulated solid tumor indications, including small cell lung cancer (SCLC), neuroendocrine tumors (NETs), neuroendocrine carcinomas (NECs), and melanoma.

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"We are excited about the progress in our Phase 1 IDE849 monotherapy study to determine the RP2D and to initiate a registrational study by year-end, and the advancement of our wholly owned first-in-class clinical combination of IDE849 and IDE161 in DLL3 upregulated solid tumor indications," said Yujiro S. Hata, President and Chief Executive Officer, IDEAYA Biosciences. "We are leveraging our deep scientific expertise in DNA damage repair to enable this rational combination with IDE161, with the goal of inducing accumulation of TOP1 lesions to enhance the clinical efficacy and durability of our proprietary TOP1-payload ADCs, including IDE849 and IDE034, a Phase 1 B7H3/PTK7 bispecific TOP1 ADC," said Michael White, Ph.D., Chief Scientific Officer, IDEAYA Biosciences.

IDEAYA is advancing a multi-site global Phase 1 clinical trial for IDE849 in DLL3 upregulated solid tumor indications, including SCLC, NETs, and NECs, and melanoma (NCT07174583). The study will be enrolling patients globally, including in North America, Europe, Australia, South America, and Asia. In this ongoing Phase 1 dose escalation study, IDE849 is currently evaluating a 3.5 mg/kg IV dose once every 3-weeks (Q3W). Next, to determine the recommended Phase 2 dose (RP2D), IDEAYA is also enrolling patients in a IDE849 expansion cohort at the 2.4 mg/kg IV dose Q3W, where multiple partial responses (PRs) have been observed by RECIST 1.1, including 3 PRs out of 4 SCLC patients pre-treated with IMDELLTRA (tarlatamab-dlle). The preliminary safety and efficacy profile observed to date in the IDEAYA sponsored study is consistent with the clinical data presented by our China-region partner Jiangsu Hengrui Pharmaceuticals Co. Ltd., at the IASLC World Conference on Lung Cancer 2025 (WCLC 2025).

In addition, IDE849 is being evaluated in a clinical combination with IDEAYA’s potential first-in-class Phase 1 PARG inhibitor, IDE161. IDEAYA has presented preclinical combination mechanism and synergy efficacy data of IDE161/PARG with TOP1-payload based ADCs at WCLC 2025. IDE161 prevents the removal of poly(ADP-ribose) chains generated by PARP during the DNA damage response, leading to persistent PARylation and impaired resolution of DNA repair complexes. Together with TOP1-payload ADCs, this unique mechanism-of-action results in sustained TOP1 cleavage complexes and the accumulation of DNA damage that delivers enhanced anti-tumor activity. We believe this potential first-in-class combination has the potential to enhance durability of IDEAYA’s TOP1-payload based ADC pipeline, including IDE849 and IDE034 (Phase 1 B7H3/PTK7 Bispecific TOP1 ADC).

DLL3 has been reported to be upregulated in multiple solid tumor types, including in SCLC, NETs, NSCLC, melanoma, among others. DLL3 has limited extracellular expression in normal tissues, making it a promising potential therapeutic target in these solid tumors, for which there remains significant unmet medical need.

(Press release, Ideaya Biosciences, MAR 30, 2026, View Source [SID1234664037])

On March 30, 2026 Harbour BioMed ("HBM" or the "Company"; HKEX: 02142), a global biopharmaceutical company committed to the discovery and development of novel antibody therapeutics in immunology, oncology and other areas, reported its financial results for the year ended December 31, 2025.

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Dr. Jingsong Wang, Founder, Chairman, and CEO of Harbour BioMed, commented: "2025 marked a pivotal year for Harbour BioMed as we entered the third phase of our strategic evolution, with a clear roadmap toward our 2028 vision of becoming a global leading platform-based biopharmaceutical group.

The Company’s strategy is powered by three integrated growth engines. These include building a global leading AI-driven antibody discovery ‘new infrastructure’ through Nona Biosciences, expanding global partnerships through platform-based collaborations with multinational pharmaceutical companies, and unlocking the global value of its mid- to late-stage pipeline in immunology, oncology and other areas through Harbour Therapeutics. These three engines connect technology platforms, global partnerships and pipeline development, forming a scalable model for sustainable innovation and long-term growth.

Leveraging our proprietary antibody discovery platforms and continued innovation in AI-enabled drug development, Harbour BioMed has built a strong global collaboration ecosystem. Looking ahead, we will continue to focus on innovation and accelerate the development of next-generation biologics to deliver transformative therapies for patients worldwide."

2025 Financial Highlights: Strong Growth and Profitability

Total Revenue reached approximately US$158 million, representing an increase of 314.6% year over year, primarily driven by long-term strategic collaborations with multinational pharmaceutical companies, global licensing agreements, and robust revenue growth fueled by the strong performance of Nona Biosciences.
Net Profit for the Year surged to approximately US$92 million, a 33-fold increase compared to full year 2024, reflecting strong revenue growth and continuous improvement in operational efficiency.
Adjusted net profit for the year[1] was approximately US$101 million, representing a 11-fold year-over-year increase.
Cash and Cash Equivalents stood at approximately US$403 million as of December 31, 2025, representing an increase of 141.6% from the end of 2024. The Company maintains strong financial resources and flexibility to execute efficient capital management initiatives.

Strategic Collaborations Fuel Global Expansion

Over the past several years, Harbour BioMed has steadily transformed the strength of its technology platforms into high-value global partnerships, building an expanding international innovation ecosystem. The Company has deepened its ties with global pharmaceutical leaders in antibody discovery and next-generation biologics development, ensuring its innovative platform technologies reached new heights.

In 2025 alone, the Company established multiple collaborations with global biotechnology innovators and multinational pharmaceutical companies, including Windward Bio, AstraZeneca, Otsuka, Pfizer and Bristol Myers Squibb. Among these, Harbour BioMed’s expanding collaboration with AstraZeneca stands as a representative example of the Company’s evolving partnership model—progressing from product licensing to a deep strategic collaboration covering multiple targets and programs. The collaboration between the two parties in 2025 is further distinguished by an innovative, multi-faceted framework that combines R&D collaboration, equity investment, and the establishment of the Harbour BioMed-AstraZeneca Innovation Lab.

Together, these collaborations underscore Harbour BioMed’s evolving platform-driven partnership model, enabling the Company to accelerate global innovation while creating long-term strategic and commercial value.

Advancing a Robust and Differentiated Pipeline

Harbour BioMed continues to advance a diversified pipeline of innovative therapeutics addressing diseases with significant unmet medical needs. With almost 20 drug candidates spanning preclinical to late-stage clinical development, the Company is building a broad portfolio across immunology, oncology and other areas, while expanding into next-generation modalities including bispecific and tri-specific T cell engagers, antibody-drug conjugates, metabolic disease therapies and central nervous system programs.

Key products in the mid-late clinical stage include:

Batoclimab (HBM9161) is the first anti-FcRn monoclonal antibody completed Phase I to pivotal trials in China. As a novel, fully human anti-FcRn monoclonal antibody, batoclimab has the potential to be a breakthrough treatment option for a wide range of autoimmune diseases. The Phase III pivotal clinical trial results of batoclimab were published in JAMA Neurology in March 2024, demonstrating sustained efficacy and safety with long-term use of batoclimab in the treatment of generalized myasthenia gravis (gMG). In July 2024, NMPA accepted the BLA for batoclimab for the treatment of gMG.

HBM9378 is a fully human monoclonal antibody against thymic stromal lymphopoietin (TSLP) generated from the H2L2 Harbour Mice platform. It potently binds to the TSLP ligand and inhibits the TSLP mediated signaling pathway by blocking the interaction between TSLP and TSLP receptor. TSLP is a well-validated cytokine that plays a key role in the development and progression of a wide array of immunological conditions, including asthma and COPD where inhibition has demonstrated benefit in a wide array of inflammatory phenotypes. HBM9378 has been engineered to achieve an extended half-life and effector silencing and is subcutaneously administered.

The Company received the IND approval of HBM9378 for moderate-to-severe asthma from the NMPA in February 2022 and completed a Phase I clinical trial in healthy subjects in China. In November 2024, the Company submitted an IND application for HBM9378 for chronic obstructive pulmonary disease (COPD) to the NMPA, which was approved in January 2025.

In January 2025, it was announced that the Company and Kelun-Biotech entered into an exclusive license agreement with Windward Bio, under which Windward Bio was granted an exclusive license for the research, development, manufacturing and commercialization of HBM9378 globally (excluding Greater China and several Southeast and West Asian countries). In July 2025, Windward Bio launched global Phase II POLARIS clinical study, assessing long-acting dosing of HBM9378/WIN378 for people living with asthma.

Note: HBM9378 is known as SKB378 in Kelun-Biotech’s pipeline and WIN378 in Windward Bio’s pipeline.

Porustobart (HBM4003) is a next-generation, fully human heavy-chain-only anti-CTLA-4 antibody discovered and developed using the HCAb Harbour Mice platform. It is also the first fully human heavy-chain-only antibody which entered clinical development globally. Compared with conventional CTLA-4 antibodies, porustobart has unique, favourable properties, including significant Treg cell depletion and optimized pharmacokinetics for improved safety. Additionally, by enhancing antibody-dependent cellular cytotoxicity (ADCC), porustobart increases the potential to selectively deplete intratumoral Treg cells, helping to overcome the efficacy and toxicity bottleneck of current CTLA-4 therapies. The Company has implemented a global development plan for multiple types of solid tumors with an adaptive treatment design for porustobart. Positive efficacy and safety data have been observed in the monotherapy trial targeting advanced solid tumors, as well as in combination trials with PD-1 inhibitors for melanoma, colorectal cancer (CRC), neuroendocrine neoplasm (NEN) and hepatocellular carcinoma (HCC).

In October 2025, the Company published positive Phase II clinical data in combination with tislelizumab, for the treatment of microsatellite stable (MSS) metastatic colorectal cancer (mCRC). Of the 23 evaluable patients, the objective response rate (ORR) is 34.8%, disease control rate (DCR) is 60.9%, and 12-month overall survival (OS) Rate is 84%.

In February 2026, the Company entered a license agreement and equity partnership with Solstice Oncology, a clinical stage biotechnology company established by a syndicate of major venture capital investors, for the exclusive development and commercialization of HBM4003 outside Greater China.

HBM7575 is a long-acting bispecific antibody targeting TSLP and an undisclosed antigen, with a dual mechanism of action. On one hand, by blocking the interaction between TSLP and its receptor, it inhibits TSLP-mediated signaling pathways and the activation of Th2 immune cells. On the other hand, binding to and blocking the undisclosed target generates a synergistic effect, overcoming resistance issues associated with TSLP single-target antibodies. HBM7575 has been engineered to possess an extended half-life and favourable developability, enabling subcutaneous administration. Based on preclinical half-life data, the anticipated human half-life is expected to support dosing intervals of more than three months, positioning it as a potential best-in-class therapy.

In December 2025, NMPA accepted the IND application for HBM7575 for the treatment of atopic dermatitis. In March 2026, the China IND application for the treatment of atopic dermatitis, has been approved by the NMPA.

Key products in the next-generation innovation portfolio include:

HBM7020 is a BCMAxCD3 bispecific antibody generated using the fully human HBICE bispecific technology and Harbour Mice platform. HBM7020 can crosslink targeted cells and T cells by binding to BCMA and CD3 on the cell surface, leading to potent T cell activation and cell elimination. By incorporating dual anti-BCMA binding sites for optimal cell targeting and monovalent-optimized CD3 activity to minimize CRS, HBM7020 demonstrated potent cytotoxicity with broad applications in both immunological and oncology diseases. In August 2023, HBM7020 obtained IND clearance from the NMPA to commence a Phase I trial for cancer in China. In June 2025, the Company entered a global strategic collaboration with Otsuka Pharmaceutical Co., Ltd. (Otsuka) to advance HBM7020 for the treatment of autoimmune diseases.

HBM7004 is a novel B7H4xCD3 bispecific antibody. Using HBICE bispecific technology and Harbour Mice platform, this bispecific antibody was designed to provide innovative solutions for cancer immunotherapy from both efficacy and safety perspectives. The development of B7H4xCD3 bispecific HBICE further consolidates the Company’s bispecific immune cell engager platform, demonstrating the HBICE platform’s versatility and plug-and-play advantages. In preclinical studies, HBM7004 demonstrated an intratumor B7H4-dependent T cell activation manner. In multiple animal models, HBM7004 showed strong anti-tumor efficacy, remarkable in vivo stability, and reduced systemic toxicity. Additionally, in preclinical models, HBM7004 exhibited a strong synergistic effect when combined with a B7H4x4-1BB bispecific antibody at a low effector-to-target cell ratio, indicating an encouraging therapeutic window. In 2025, the Company continued the development in pre-clinical and advanced to IND-enabling stage for HBM7004.

Metabolic Disease Programs: The Company is developing innovative therapies for obesity-related conditions to address key challenges in current obesity treatments, including muscle preservation and long-term efficacy. Multiple programs currently in preclinical development, each designed to offer innovative mechanisms of action, including targeted hormone modulation and enhanced metabolic regulation. By integrating dual-targeting strategies with enhanced safety profiles, these therapies have the potential to complement and expand upon existing treatment options, including various agonists of GLP-1 receptor, GIP receptor, and GCG receptor. These programs are supported by the Company’s antibody discovery platform and Hu-mAtrIxTM AI platform, with AI applications guiding antibody sequence discovery, enrichment, optimization, bispecific geometry design, and developability/immunogenicity/pharmacokinetics (PK) assessments, as well as patient biomarker studies.

CNS Disease Programs: Resilience Neuroscience, a wholly-owned subsidiary of the Company, is advancing a next-generation central nervous system (CNS) pipeline focused on Alzheimer’s disease, Parkinson’s disease, and other neurodegenerative disorders. Multiple programs are currently in preclinical development, targeting well-validated CNS pathways. By significantly enhancing central nervous system delivery and extending half-life, these programs aim to amplify therapeutic efficacy and deliver next-generation best-in-class (BIC) and first-in-class (FIC) therapeutics. This approach is enabled by our proprietary platform technologies, including HCAb-based blood-brain barrier (BBB) shuttle platforms for brain-penetrant antibody delivery and BBB shuttle-conjugated ASO/siRNA modalities, designed to overcome the key barriers in CNS drug development.

Powering Next-Generation Therapeutics Through Platform Innovation and Venture Incubation

Technology platform innovation remains a core pillar of Harbour BioMed’s long-term strategy and a key driver of its research productivity and business development success. By continuously advancing its proprietary antibody discovery platforms including Harbour Mice, HCAb-based antibody technologies and multi-specific antibody engineering capabilities, the Company is enhancing the efficiency of antibody discovery while enabling the development of next-generation biologics across multiple therapeutic areas.

Building on the foundation, Harbour BioMed is increasingly integrating artificial intelligence with advanced antibody engineering to further accelerate discovery. One of Harbour BioMed’s most exciting innovations in 2025 has been the launch of its first fully human Generative AI HCAb Model powered by the Hu-mAtrIx AI platform. Built on more than nine million next-generation sequencing-derived HCAb sequences, the platform integrates AI-driven design, intelligent screening and wet-lab validation to establish a closed-loop discovery process for antibody development. To further advance AI-enabled innovation, Harbour BioMed also launched the Global AI + Pharmaceutical Ecosystem Alliance in 2025, bringing together technology partners, industry experts and investors to accelerate AI-driven drug discovery.

These platform capabilities have played an important role in supporting the Company’s expanding pipeline and global collaborations with leading pharmaceutical partners, further demonstrating the commercial and scientific value of Harbour BioMed’s technology platforms.

Beyond advancing internal R&D capabilities, Harbour BioMed is also leveraging its proprietary technologies to drive new innovation models. Through its "technology for equity" approach, the Company continues to incubate next-generation biotechnology ventures, expanding the application scenarios of its platform technologies while creating additional long-term value.

With flexible capital investment, Harbour BioMed has incubated several ventures focused on cutting-edge therapeutic areas, ranging from multivalent antibodies to cell therapies. These include collaborations with NK Cell-Tech in NK cell therapies, as well as incubating Élancé Therapeutics, which focuses on next-generation obesity treatments, and Resilience Neuroscience, dedicated to therapies for neurodegenerative diseases. Harbour BioMed has also co-founded Sobour Biopharma to develop innovative therapies for cancer and inflammatory diseases.

Together, these initiatives highlight the broad potential of Harbour BioMed’s technology platforms and demonstrate how the Company’s platform-driven innovation model continues to generate new opportunities for scientific advancement and future growth.

Outlook: Driving the Next Phase of Global Growth

Looking ahead, Harbour BioMed will continue to drive sustainable business growth and fulfill its 2028 vision of becoming a global leading platform-based biopharmaceutical group through the three integrated growth engines.

In 2026, the Company expects to advance multiple high-potential assets into mid- to late-stage clinical development and progress additional innovative candidates into the clinical stage across immunology, oncology, and other therapeutic areas with high unmet medical needs. Meanwhile, the Company will actively explore various opportunities to accelerate its portfolio and platform value realization and strengthen its role in the global innovation ecosystem by expanding collaborations with global partners.

By integrating technology platforms, pipeline innovation and global partnerships, Harbour BioMed remains committed to delivering transformative biologic therapies to patients worldwide and further strengthening its position as a globally competitive innovator in next-generation biotherapeutics.

(Press release, Harbour BioMed, MAR 30, 2026, View Source [SID1234664036])