On March 30, 2026 UroGen Pharma Ltd. (Nasdaq: URGN), a biotech company dedicated to developing and commercializing innovative solutions that treat urothelial and specialty cancers, reported the publication of results from the pivotal Phase 3 ENVISION trial of ZUSDURI (mitomycin) for intravesical solution in The Journal of Urology. ZUSDURI is indicated for the treatment of adults with recurrent low-grade intermediate-risk non-muscle invasive bladder cancer (LG-IR-NMIBC). The publication reports a 72.2% probability of remaining event-free at 24 months after complete response (CR) (95% CI: 64%, 79%) as determined by Kaplan-Meier analysis. The CR rate at three months was 79.6%. The median follow-up time after three-month CR was 23.7 months, and the median DOR was not reached.

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"The publication of these long-term data in The Journal of Urology provides important peer-reviewed validation of the durability of ZUSDURI treatment observed in the ENVISION trial," said Sandip Prasad, M.D., M.Phil., Director of Genitourinary Surgical Oncology and Vice Chair of Urology at Morristown Medical Center/Atlantic Health System, New Jersey, and Principal Investigator of the ENVISION trial. "For patients who achieved a complete response, the likelihood of remaining event-free through two years was substantial, underscoring the potential of ZUSDURI to change the long-term management of this highly recurrent disease with a six-week induction treatment alone without maintenance. For the first time, adult patients with recurrent LG-IR-NMIBC have an FDA-approved therapy."

The existing standard of care for LG-IR-NMIBC is transurethral resection of bladder tumor (TURBT), a surgical procedure typically performed under general anesthesia. Due to high recurrence rates, patients, who are often elderly with multiple comorbidities, may require repeated TURBT procedures over their lifetime, which can negatively impact quality of life and may be associated with increased health risks. An estimated 59,000 patients with LG-IR-NMIBC experience recurrence annually in the United States.

"Now that the 24-month duration of response data from ENVISION are published in a leading urology journal, we’re seeing even stronger validation of ZUSDURI’s clinical impact," said Mark Schoenberg, Chief Medical Officer, UroGen. "As the first and only approved treatment for recurrent LG-IR-NMIBC, ZUSDURI gives patients a real chance at meaningful, recurrence-free periods. These results suggest we may finally be able to break the long-standing cycle of repeated recurrences and surgeries that has defined care for patients with recurrent LG-IR-NMIBC."

The most common (≥10%) adverse reactions, including laboratory abnormalities, observed in patients treated with ZUSDURI were dysuria, hematuria, urinary tract infection, increased creatinine, increased potassium, decreased hemoglobin, decreased lymphocytes, decreased neutrophils, increased eosinophils, and increased liver enzymes (AST and ALT). Adverse reactions were primarily mild to moderate in severity. Serious adverse reactions occurred in 12% of patients and included urinary retention (0.8%) and urethral stenosis (0.4%).

About ZUSDURI

ZUSDURI (mitomycin) for intravesical solution is an innovative drug formulation of mitomycin approved for the treatment of adults with recurrent LG-IR-NMIBC. Utilizing UroGen’s proprietary RTGel technology (a sustained release, hydrogel-based formulation), ZUSDURI is delivered directly into the bladder by a trained healthcare professional using a urinary catheter in an outpatient setting, thereby enabling the treatment of tumors by non-surgical means.

About Non-Muscle Invasive Bladder Cancer (NMIBC)
LG-IR-NMIBC affects around 82,000 people in the U.S. every year and of those, an estimated 59,000 are recurrent. Bladder cancer primarily affects older populations with increased risk of comorbidities, with the median age of diagnosis being 73 years. Guideline recommendations for the management of NMIBC include transurethral resection of bladder tumor (TURBT) as the standard of care. Up to 70 percent of NMIBC patients experience at least one recurrence, and LG-IR-NMIBC patients are even more likely to recur and face repeated TURBT procedures. Learn more about non-muscle invasive bladder cancer at www.BladderCancerAnswers.com.

(Press release, UroGen Pharma, MAR 30, 2026, View Source [SID1234664030])

On March 30, 2026 INmune Bio Inc. (NASDAQ: INMB) (the "Company"), a late-stage biotechnology company focused on inflammation and immunology, reported its financial results for the year ended December 31, 2025 and provides a business update.

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Recent Corporate Highlights

CORDStrom Platform:

The CORDStrom program in recessive dystrophic epidermolysis bullosa (RDEB) is on target to file an MAA submission in the UK mid-summer, followed shortly thereafter by anticipated EMA and FDA regulatory submissions.
Hosted KOL led webinar focused on the latest results from the MissionEB Phase III clinical trial highlighting the systemic disease-modifying capabilities of CORDStrom in patients with RDEB.
Announced the publishing of an overview of future applications and research areas for mesenchymal stromal cell (MSC) therapies in the peer-reviewed journal Cytotherapy.
XPro Platform:

Reported new Phase 2 imaging data at the 18th Clinical Trials on Alzheimer’s Disease conference (CTAD), in San Diego, CA. Additional brain imaging analyses are ongoing and expected to be reported in the near future.
Announced FDA alignment to advance to an adaptive Phase 2b/3 registrational pathway with XPro in early Alzheimer’s Disease.
Hosted expert-led webinar on XPro registrational study strategy for early Alzheimer’s Disease, with the discussion focused on results of the Phase 2 MINDFuL trial and alignment with the FDA following the End-of-Phase 2 meeting.
INmune’s MINDFuL trial was featured in a plenary presentation at the AD/PD 2026 conference as a successful example of how aligning patient selection with mechanism of action identifies the patients most likely to respond.
INKmune Platform:

Met primary and two of three secondary endpoints in CARE-PC trial
Continued evaluation of clinical data from the INKmune CARE-PC trial in metastatic castration-resistant prostate cancer.
Ongoing analysis of immune activation and tumor response endpoints to inform future development strategy.
Corporate:

Received Australian R&D rebate of $5.2m AUD ($3.6 million USD) during January 2026.
Company estimates that cash on hand provides runway through Q1 of 2027.
During 2025, the Company sold 4,304,707 shares of common stock in exchange for net cash proceeds of $27.5 million.
Continued alignment of capital allocation with clinical development priorities.
Upcoming Events and Milestones:

The Marketing Authorization Application (MAA) for CORDStrom is scheduled for submission to the UK’s MHRA in mid-summer, followed directly by an EMA filing.
CORDStrom Biologics License Application (BLA) submission to the FDA expected in Q4 2026.
"Reflecting on the progress of 2025 and the momentum of early 2026, it is clear that INmune Bio has reached a defining inflection point," said David Moss, CEO of INmune Bio. "We have transitioned from a mid-stage clinical company into a late-stage, registration-directed organization. Our mission to harness the innate immune system to treat diseases of inflammation has never been more tangible or more urgent. Looking ahead through 2026 and 2027, our strategy is anchored by two late-stage assets that represent significant value for both patients and shareholders: CORDStrom and XPro."

CORDStrom: A Clear Path to Commercialization

CORDStrom, our mesenchymal stromal cell platform for Recessive Dystrophic Epidermolysis Bullosa, is our most immediate commercial catalyst.

2026 Regulatory Milestones: In February, we formally submitted our pre-submission package to the UK’s MHRA. A face-to-face meeting with the MHRA is scheduled for mid-May. We remain on track to file our first Marketing Authorization Application (MAA) in the UK by mid-summer 2026, followed by EU and U.S. (BLA) filings in Q4.
Operational Readiness: We have successfully completed three commercial pilot-scale manufacturing runs at our Stevenage facility, meeting all release criteria. This ensures we are ready to supply the market upon approval.
Financial Strategy: With the recent reauthorization of the Rare Pediatric Disease Priority Review Voucher (PRV) program through 2029, CORDStrom offers a dual-value proposition: a life-changing therapy for "butterfly children" and a high-value PRV that can be monetized to non-dilutively fund our long-term operations.
XPro: Redefining the Alzheimer’s Paradigm

The landscape of Alzheimer’s disease (AD) is shifting toward precision medicine, and INmune Bio is at the forefront.

2026 Focus: Following our successful End-of-Phase 2 meeting with the FDA in February, we have achieved alignment on an integrated Phase 2b/3 registrational pathway. Unlike traditional "all-comer" trials, our program uses a biomarker-enriched design, targeting patients with neuroinflammation. This "precision" approach, validated by our MINDFuL trial data featured at the AD/PD 2026 Plenary, significantly de-risks our path forward.
2027 Horizon: Our Phase 2b/3 program is built to bridge the gap between early cognitive signals (EMACC) and late-stage functional outcomes (CDR-SB). The Phase 2b stage evaluates co-primary endpoints at nine months and serves as a clearly powered go or no-go before we commit to the full Phase 3 registrational portion of the trial. If EMACC and/or pTau-217 readout successfully in the Phase 2b portion of the trial, it advances seamlessly into the registrational stage Phase 3 with CDR-SB at eighteen months (the same primary endpoint used to approve lecanemab and donanemab). The scientific basis for this design is well established: cognitive changes (EMACC) precede and predict functional decline (CDR-SB), which means early cognitive signals at nine months support confidence in functional outcomes at eighteen. We believe this program represents a compelling partnership opportunity, while remaining a viable path for independent development following CORDStrom approval, assuming favorable capital conditions.
Notably, XPro has reported zero cases of ARIA across all clinical studies to date, a critical differentiator in a treatment landscape where ARIA remains a significant limitation of approved therapies.

"From a capital perspective, we remain committed to capital efficiency," said Mr. Moss. "Our strategy is built on hitting clear, data-driven milestones that allow us to maximize shareholder value while minimizing unnecessary burn. We are focused on maintaining the lean, execution-oriented culture that has brought us to this stage."

"2026 is the year of filings and preparation; 2027 will be the year of pivotal execution and potential launch. We thank you for your continued trust and partnership as we work to transform the treatment of inflammatory disease."

Financial Results for the Year Ended December 31, 2025

Net loss attributable to common stockholders for the year ending December 31, 2025 was approximately $45.9 million, compared to approximately $42.1 million during the year ended December 31, 2024.
Research and development expenses totaled approximately $20.7 million for the year ended December 31, 2025, compared to approximately $33.2 million during the year ended December 31, 2024.
General and administrative expenses were approximately $10.3 million for the year ended December 31, 2025, compared to approximately $9.5 million during the year ended December 31, 2024.
Impairment of acquired in-process research and development intangibles assets was $16.5 million during the year ended December 31, 2025, compared to $0 during the year ended December 31, 2024.
As of December 31, 2025, the Company had cash and cash equivalents of approximately $24.8 million.
As of December 31, 2025, the Company had approximately 26.6 million common shares outstanding.
Earnings Call Information

To participate in this event, dial approximately 5 to 10 minutes before the beginning of the call. Please ask for the INmune Bio Fourth Quarter and Full Year Ended December 31, 2025 Conference Call when reaching an operator.

Date: March 30th, 2026

Time: 4:30 PM Eastern Time

Participant Dial-in: 1-800-343-4136
Participant Dial-in (international): +1-203-518-9843

Conference ID: INMUNE

A live audio webcast of the call can be accessed using this link or clicking here:
View Source;tp_key=96ca7c85d7

A replay will be available approximately 3 hours after the call through April 13, 2026 by dialing 1-844-512-2921 or 1-412-317-6671 (international) and entering PIN no. 11160807.

About CORDStrom

CORDStrom is a patent-pending cell medicine comprising aseptic, allogeneic, pooled human umbilical cord-derived mesenchymal stromal cells (hucMSCs) in suspension for injection or infusion. The CORDStrom platform leverages, among other things, proprietary screening, pooling and expansion techniques to create off-the-shelf, allogeneic, pooled hucMSCs as medicines to treat complex inflammatory and autoimmune diseases. CORDStrom products are designed to provide high-quality, off-the-shelf, batch-to-batch consistent, scalable, cGMP manufactured, potent cellular medicines that can be produced affordably and with repeatable specification. Pooling allows tuning of different CORDStrom products with different effector functions dependent upon selected donor characteristics. While the first generation CORDStrom product is agnostic to disease indication, the platform enables creation of indication-specific products, which can be tuned for optimization of anti-inflammatory, immunomodulatory, wound healing, and other characteristics.

About XPro

XPro is a next-generation inhibitor of tumor necrosis factor (TNF) that is currently in clinical trial and acts differently than currently available TNF inhibitors in that it neutralizes soluble TNF (sTNF), without affecting trans-membrane TNF (tmTNF) or TNF receptors. XPro could have potential substantial beneficial effects in patients with neurologic disease by decreasing neuroinflammation. For more information about the importance of targeting neuroinflammation in the brain to improve cognitive function and restore neuronal communication, visit our website at www.inmunebio.com.

(Press release, INmune Bio, MAR 30, 2026, View Source [SID1234664051])

On March 30, 2026 Anixa Biosciences, Inc. ("Anixa" or the "Company") (NASDAQ: ANIX), a biotechnology company focused on the treatment and prevention of cancer, reported that Dr. Robert Wenham, Chair of the Gynecologic Oncology Department at Moffitt Cancer Center and principal investigator for the Company’s ongoing ovarian cancer CAR-T therapy Phase 1 trial, will be presenting at the Society of Gynecologic Oncology (SGO) Annual Meeting on Women’s Cancer, being held April 10 – 13, 2026, in San Juan, Puerto Rico.

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Dr. Wenham’s presentation, titled "Phase 1 clinical trial of autologous T cells genetically engineered with a chimeric receptor to target the follicle-stimulating hormone receptor (FSHR) in recurrent ovarian cancer," will discuss the clinical trial design and objectives, as well as the current status of Anixa’s ongoing Phase 1 clinical trial of lira-cel.

The SGO Annual Meeting on Women’s Cancer stands as the foremost educational and scientific gathering for professionals dedicated to the treatment and care of individuals with gynecologic cancer, bringing together global experts in gynecologic oncology to share the latest scientific advancements, participate in educational programs, and network with peers.

About Lira-cel, Anixa’s CAR-T Therapy for Recurrent Ovarian Cancer
Liraltagene autoleucel, or lira-cel, uniquely targets the follicle-stimulating hormone receptor (FSHR), which is selectively expressed on ovarian cells, tumor vasculature, and certain cancer cells, but not in healthy tissue. The ongoing Phase 1 trial (ClinicalTrials.gov NCT05316129) is enrolling adult women with recurrent ovarian cancer who have progressed after at least two prior therapies.

(Press release, Anixa Biosciences, MAR 30, 2026, View Source [SID1234664016])

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])

On March 30, 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 the confirmation of a partial response (PR) in its ongoing ACESOT-1051 trial evaluating APR-1051, a potent and selective WEE1 kinase inhibitor.

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The confirmed PR was observed in a patient with PPP2R1A-mutated endometrial cancer who is currently being treated at the 220 mg once daily dose level. Aprea announced on February 18, 2026 that, at their first imaging assessment, this patient achieved a 50% reduction in target lesion size (meeting RECIST criteria for partial response) as well as a reduction in CA-125 levels. This response was subsequently confirmed at the second image assessment, with an additional 9.5% reduction in target lesion size, and a reduction in CA-125 to 40.2U/ml (from 362 U/mL at baseline).

ACESOT-1051 is a biomarker focused Phase 1 trial designed to evaluate the safety, tolerability, pharmacokinetics, and preliminary anti-tumor activity of APR-1051 in patients with advanced solid tumors harboring cancer-associated genetic alterations. A total of 24 patients have been treated to date, at doses ranging from 10 mg to 220 mg once daily. Two patients have achieved partial responses, both with endometrial cancers harboring PPP2R1A mutations. One of these responses has been confirmed, as described above. Both patients remain on treatment.

Five other patients in ACESOT-1051 have achieved a best overall response of 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 generally safe and well tolerated with the most common adverse events reported as Grade 1 or 2, primarily consisting of nausea and fatigue.

"The data emerging from the ACESOT-1051 trial continue to support the clinical potential of APR-1051, with confirmation of a partial response in the 220 mg cohort indicating evidence of sustained anti-tumor activity," said Eugene Kennedy, MD, Chief Medical Advisor at Aprea. "APR-1051 appears to be generally well-tolerated with an encouraging therapeutic window and overall, these findings strengthen our confidence in the ability of this candidate to successfully target WEE1 in genetically defined cancers, where patients face significant unmet need."

Dose escalation is ongoing, with plans to advance to Dose Level 9 (300 mg once daily) in the second quarter of 2026. In parallel, the company plans to enroll additional patients as specified in the protocol based on the understanding that their tumor types or specific mutations gives them an increased probability of responding to this class of potential therapeutics. This includes patients with uterine serous carcinoma (a subset of endometrial), colorectal and HPV+ tumors. For more information on ACESOT-1051, refer to ClinicalTrials.gov NCT06260514.

(Press release, Aprea, MAR 30, 2026, View Source [SID1234664017])