On March 24, 2026 Silexion Therapeutics Corp. (NASDAQ: SLXN) ("Silexion" or the "Company"), a clinical-stage, oncology-focused biotechnology company, reported that it has received formal approval from the Israeli Ministry of Health to initiate its Phase 2/3 clinical trial evaluating SIL204 for the treatment of locally advanced pancreatic cancer, following positive preclinical results that demonstrated significant anti-tumor activity in mulitple models alongside successful completion of toxicology studies.

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This approval represents a major regulatory milestone and a critical advancement for the Company, enabling the transition of SIL204 into human clinical evaluation and positioning Silexion as a clinical-stage biotechnology company focused on KRAS-driven cancers.

SIL204 is designed to silence KRAS mutations, which are present in over 90% of pancreatic cancers and are widely recognized as one of the most challenging targets in oncology. Unlike mutation-specific approaches, SIL204 is engineered to target a broad range of KRAS mutations, supporting its potential applicability across multiple high-value cancer indications.

The approval follows a series of major positive developments achieved by the Company, including strong positive anti-tumor activity demonstrated in multiple preclinical models, successful completion of toxicology studies, and constructive regulatory engagement supporting the Phase 2/3 trial design. Together, these achievements have enabled SIL204 to advance toward clinical-stage development. The Company also plans to submit a Phase 2/3 clinical trial application in Germany by the end of this current quarter, with additional regulatory filings across the European Union planned in early 2027.

"The receipt of this approval marks a defining and highly significant milestone for Silexion," said Ilan Hadar, Chairman and Chief Executive Officer of Silexion Therapeutics. "We are now advancing SIL204 into a pivotal clinical trial with the goal of addressing KRAS-driven cancers at their source. This progress reflects the strength of our data, the safety demonstrated during the Loder (predecessor to SIL204) clinical trial, the urgency of the unmet need in pancreatic cancer, and our continued execution toward developing a potentially transformative therapy."

The Company expects to initiate the Phase 2/3 trial in the second quarter of 2026, subject to site activation and standard clinical readiness procedures, and plans to advance SIL204 as a potential treatment across additional KRAS-driven indications, including colorectal and lung cancers.*

(Press release, Silexion Therapeutics, MAR 24, 2026, View Source [SID1234663884])

On March 24, 2026 Biomea Fusion, Inc. ("Biomea" or "Biomea Fusion" or "the Company") (Nasdaq: BMEA), a clinical-stage diabetes and obesity company, reported its financial results for the full year ended December 31, 2025, and provided a business update.

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"The past year was a year of execution for Biomea as we advanced from validating the menin pathway in primarily preclinical experiments to now generating durable, clinical data in patients with type 2 diabetes with our lead asset, icovamenib," said Mick Hitchcock, Ph.D., Interim Chief Executive Officer and Board Member of Biomea Fusion. "We reported persistent 52-week clinical activity with icovamenib following a short 12-week treatment course. Following these initial findings, we initiated two Phase II studies in type 2 diabetes from which we expect to have primary end point data before year end. We also advanced our own next-generation oral GLP-1 receptor agonist, BMF-650, into a Phase I study which we expect will read out in the second quarter. We are excited about the current momentum as we believe Biomea is well positioned to execute on key value-creating milestones with multiple data readouts from our four clinical studies, while predicting a cash runway into the first quarter of 2027."

Recent Corporate Highlights:

Icovamenib
Potential First-in-Class Oral Small Molecule Product Candidate Targeting Menin for Diabetes

The Company presented 52-week follow-up data from the Phase II COVALENT-111 study in patients with type 2 diabetes not achieving glycemic targets despite standard of care therapy. The data demonstrated durable and clinically meaningful reductions in HbA1c that persisted nine months after completion of a 12-week treatment course.
In patients with severe insulin-deficient type 2 diabetes receiving one or more antihyperglycemic agents at baseline, icovamenib achieved a 1.2% mean reduction in HbA1c (p=0.01) that was maintained through Week 52 following 12 weeks of dosing.
In a subgroup of patients receiving GLP-1 RA-based therapy who had not achieved glycemic targets at study entry, icovamenib achieved a 1.2% mean reduction in HbA1c (p=0.05) that was maintained through Week 52 following 12 weeks of dosing.
In both populations, icovamenib treatment was associated with increased C-peptide levels measured off treatment, supporting the proposed mechanism of action of restoration of beta cell function.
Icovamenib was generally well tolerated across all dosing arms, with no treatment-related serious adverse events or treatment discontinuations observed during the 52-week observation period.
The Company completed the COVALENT-121 food-effect study which demonstrated that icovamenib achieved optimal pharmacokinetic exposure and a safety profile consistent with prior clinical experience when administered within 30 minutes after a meal. These findings informed our dosing strategy for ongoing Phase II studies.
The Company also completed the 52-week follow-up from the Phase II COVALENT-112 study in patients with type 1 diabetes. Patients who completed at least 80% of their planned dosing will be reviewed for their 52-week follow-up data per the study protocol. This read-out is expected in the second quarter of 2026.
Two Phase II clinical studies evaluating icovamenib in type 2 diabetes have been initiated:
COVALENT-211, a Phase II, randomized, double-blind, placebo-controlled study in patients with insulin-deficient type 2 diabetes not achieving glycemic targets despite standard of care therapy.
COVALENT-212, a Phase II, randomized, double-blind, placebo-controlled study in patients with type 2 diabetes not achieving glycemic targets while on a GLP-1 RA-based therapy.
Both studies are designed with a 26-week primary endpoint, with topline data anticipated in the fourth quarter of 2026.
BMF-650
Next-generation Oral Small Molecule GLP-1 RA Product Candidate for Obesity

In preclinical studies, BMF-650 demonstrated robust, dose-dependent weight reduction of up to approximately 15% in obese non-human primates and was generally well tolerated.
GLP-131, a Phase I randomized, double-blind, placebo-controlled clinical study evaluating the safety, tolerability, pharmacokinetics, and pharmacodynamics of BMF-650 in otherwise healthy overweight or obese participants is ongoing.
Initial 28-day clinical weight reduction data from the Phase I GLP-131 study is anticipated in the second quarter of 2026.
Year End 2025 Financial Results

Cash, Cash Equivalents, and Restricted Cash: As of December 31, 2025, the Company had cash, cash equivalents and restricted cash of $56.2 million, compared to $58.6 million as of December 31, 2024.
Net Loss: The Company reported a net loss attributable to common stockholders of $61.8 million for the year ended December 31, 2025, which included $9.5 million of stock-based compensation, compared to a net loss of $138.4 million for the same period in 2024, which included $19.1 million of stock-based compensation.
Research and Development (R&D) Expenses: R&D expenses were $62.0 million for the year ended December 31, 2025 compared to $118.1 million for the same period in 2024. The decrease of $56.1 million was primarily due the decrease of $42.7 million in external costs primarily driven by a decrease of $28.5 million related to clinical activities due to our strategic realignment to focus on our core assets and ceasing internal development of our oncology programs, a decrease of $4.4 million in manufacturing costs, a decrease of $4.0 million related to consultants, advisors and other professional services to support our clinical studies, discovery research and overall research and development program, and a decrease of $5.8 million related to preclinical and exploratory programs. Personnel-related expenses, including stock-based compensation, decreased by $11.3 million due to a decrease in headcount. Facilities and other allocated expenses decreased by $2.1 million due to a decrease in rent and facilities-related costs.
General and Administrative (G&A) Expenses: G&A expenses were $19.3 million for the year ended December 31, 2025 compared to $26.0 million for the same period in 2024. The decrease of $6.7 million was primarily driven by a decrease of $5.9 million related to personnel-related expenses, including stock-based compensation, due to a decrease in headcount. Consulting and professional expenses decreased by $0.7 million due to legal, accounting, consulting and other services. Facilities and other allocated expenses decreased by $0.1 million due to a decrease in rent and facilities-related costs.

(Press release, Biomea Fusion, MAR 24, 2026, View Source [SID1234663869])

On March 24, 2026 CytoDyn Inc. (OTCQB: CYDY) ("CytoDyn" or the "Company"), a clinical-stage oncology company advancing leronlimab, a first-in-class humanized monoclonal antibody targeting the CCR5 receptor with therapeutic potential across multiple indications, including metastatic triple-negative breast cancer ("mTNBC") and colorectal cancer ("mCRC"), reported the presentation of new preclinical and translational data supporting the potential role of CCR5 inhibition in glioblastoma multiforme (GBM) at AACR (Free AACR Whitepaper) Special Conference in Cancer Research: Brain Cancer, held March 23-25, in Philadelphia.

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Glioblastoma multiforme (GBM) is an aggressive brain cancer with poor survival and limited effective treatment options. Standard therapies such as radiation and temozolomide (TMZ) often face resistance, and immune checkpoint inhibitors have shown limited benefit. Molecular profiling has shown that the tumor "core" of GBM is frequently characterized by a hypoxic, mesenchymal and immunosuppressive environment that contributes to treatment resistance. The data presented evaluate the role of CCR5 in these tumor core features and explore whether CCR5 inhibition with leronlimab may enhance responses to standard-of-care therapies.

"Our findings show that CCR5 expression correlates with glycolytic and hypoxic tumor core signatures, as well as markers of T-cell exhaustion," said Professor Richard Pestell, M.D., Ph.D., FRCP, AO, Lead Consultant in Preclinical and Clinical Oncology at CytoDyn. "Importantly, CCR5 inhibition with leronlimab enhanced tumor cell killing when combined with temozolomide or radiation, support further clinical evaluation of leronlimab as a potential adjunct to standard-of-care therapy in glioblastoma."

"These data, including the intriguing but preliminary results from a preclinical study in GBM, reinforce observations from other clinical and preclinical studies that demonstrate a striking impact of leronlimab in solid tumor oncology," said Dr. Jacob Lalezari, M.D., Chief Executive Officer of CytoDyn. "These data outline a potential role for CCR5 in glioblastoma, where resistance to standard therapies remains a major unmet need. The observed synergy with temozolomide or radiation, combined with its association with immunosuppressive tumor core signatures, supports current plans to initiate a pilot study evaluating leronlimab in glioblastoma."

Key findings:

In primary GBM tumors (N=154), CCR5 expression was significantly elevated compared to normal brain tissue and correlated with poor prognosis.
CCR5 expression aligned with tumor "core" rather than "leading edge" gene signatures and correlated with hallmarks of glycolysis, hypoxia, inflammatory response, and the mesenchymal (MES) GBM subtype.
CCR5 expression was associated with T-cell exhaustion markers (PD-1, PD-L1, TIM3, PTX3) and immune suppressive mediators including S100A4. Single-cell sequencing confirmed expression of CCR5 and its ligand CCL5 within the GBM tumor microenvironment and tumor glial metabolic subtypes.
In human GBM cell lines, CCR5 abundance increased upon neurosphere formation. CCR5 inhibition with leronlimab or maraviroc demonstrated functional synergy with temozolomide, enhancing tumor cell killing. Pretreatment with leronlimab also enhanced radiation-induced cytotoxicity.
Metabolic profiling using Seahorse analysis showed that CCR5 inhibition reduced oxygen consumption rate (OCR) in a dose-dependent manner, consistent with modulation of glycolytic and metabolic programs that contribute to an immunosuppressive tumor microenvironment.

The poster, titled "CCR5 inhibition with the human monoclonal antibody leronlimab enhances temozolomide- and radiation-induced killing of glioblastoma multiforme cells," was presented by Ritika Harish on March 23, 2026, from 7:15 p.m. – 9:15 p.m. EDT (Poster #A002). A copy of the poster will be made available on CytoDyn’s website under the Publications & Posters section."

Leronlimab has previously demonstrated a favorable safety profile in clinical studies and has been shown to cross the blood-brain barrier in non-human primate models. Together with encouraging long-term survival observations in metastatic breast cancer in combination immunotherapy settings, these findings support continued investigation of CCR5 blockade across solid tumor indications.

(Press release, CytoDyn, MAR 24, 2026, View Source [SID1234663885])

On March 24, 2026 WuXi Biologics (Cayman) Inc. ("WuXi Biologics" or "the Group", stock code: 2269.HK), a leading global Contract Research, Development and Manufacturing Organization (CRDMO) offering end-to-end solutions for biologics discovery, development and manufacturing, reported audited results for the year ended December 31, 2025 ("Reporting Period").

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Financial Highlights

Revenue: Revenue increased 16.7% YoY to RMB21.8 billion, driven by continued execution of the Group’s "Follow and Win the Molecule" strategy, rising demands for complex biologics modalities including bispecific antibodies and ADCs, growing Research Services partnerships, and higher utilization of existing and newly expanded manufacturing capacity, including the ramp-up of the Group’s European facility.

Gross Profit and Gross Profit Margin: IFRS gross profit increased 30.9% YoY to RMB10.0 billion, with gross margin expanding 500 bps to 46.0%. Adjusted gross profit rose 25.5% YoY to RMB10.6 billion, with adjusted gross margin of 48.8%. Margin expansion was primarily driven by favorable business mix, higher capacity utilization, and efficiency gains from WBS and digitalization initiatives.

EBITDA and EBITDA Margin: EBITDA grew 38.1% YoY to RMB9.0 billion, while adjusted EBITDA increased 22.8% YoY to RMB9.8 billion. EBITDA margin reached 41.5%, with adjusted EBITDA margin expanding to 45.1%.

Net Profit and Net Profit Attributable to Owners of the Company: IFRS net profit rose 45.3% YoY to RMB5.7 billion, while net profit attributable to owners of the Company grew 46.3% to RMB4.9 billion. These increases were primarily driven by the higher gross profits and the gains from the Group’s investment portfolio.

Adjusted Net Profit and Adjusted Net Profit Attributable to Owners of the Company: Adjusted net profit increased 22.0% YoY to RMB6.6 billion, while adjusted net profit attributable to owners of the Company rose 17.9% YoY to RMB5.6 billion.

Earnings Per Share (EPS): Basic EPS rose 48.8% to RMB1.22 (2024: RMB0.82). Diluted EPS advanced 48.7% to RMB1.16 (2024: RMB0.78)

Adjusted Earnings Per Share (Adjusted EPS): Adjusted basic EPS increased 19.7% to RMB1.40 (2024: RMB1.17), while adjusted diluted EPS reached RMB1.33, up 18.8% from RMB1.12 in the prior year.

Business Highlights

Integrated Project Adds
The Group added a record-high of 209 new integrated projects in 2025, bringing the total pipeline to 945 programs. Approximately half of the new additions originated from U.S. clients, reflecting strong momentum from the U.S. biopharma sector. With 74 late-stage and 25 commercial projects, the Group is well positioned to drive sustained manufacturing revenue growth.

Of the 209 new additions, 23 programs were post-IND wins under the Group’s "Win-the-Molecule" strategy, including 6 late-stage programs, bringing total "Win-the-Molecule" projects to 112 since 2018.

Research
Research Services delivered another phenomenal year in 2025, generating record-high upfront and total payments, and securing potential milestone and royalties over US$4 billion.

CD3 T-cell engager (TCE) partnerships continued to expand during the year, reflecting growing industry adoption of the Group’s leading CD3 platform. The platform has been adopted by many leading biopharma companies, including Vertex, Merck, GSK and Sino Biopharmaceutical.

As of year-end 2025, Research Services supported 50+ active programs eligible for milestone payments and sales royalties, providing a growing base of high-margin long-term revenue potential.

Development
The Group supported 156 IND filings in 2025, and expanded capacity to 200 INDs and 20 BLAs/MAAs annually. It also added a record number of new development projects in 2025. Bispecifics and ADCs accounted for 2/3 of new additions, with each modality growing by approximately 30% to 196 and 252 programs, respectively. Complex modalities now represent more than half of the entire project portfolio, reflecting sustained momentum in next-gen biologics and the Group’s leading market position.

Leveraging its integrated R-D-M capabilities, bi- & multi-specifics have emerged as the Group’s fastest growing modality, contributing nearly 20% of total revenue in 2025 and delivering 120%+ YoY growth. To support continued pipeline growth, the Group has expanded regulatory submission capacity to support approximately 200 INDs and 20 BLAs/MAAs annually.

During the Reporting Period, the Group introduced WuXia TrueSite, a targeted-integration CHO cell line platform that enables 6-month DNA-to-IND timelines, while delivering 8+ g/L mAb titers and >99% expression stability across 60 generations. The Group also expanded its high-dose drug delivery capabilities for clinical and commercial applications, including WuXiHighTM high-throughput formulation development, hyaluronidase co-formulation, and large-volume device solutions, further broadening their addressable commercial opportunities.

Manufacturing
In 2025, the Group supported 74 Phase III projects and 25 commercial manufacturing projects, completed 28 PPQs (process performance qualification), and has 34 PPQs scheduled for 2026 based on contracts as of Dec 31, 2025. The Group maintained a 100% PPQ campaign success rate, demonstrating consistent execution and a robust large-scale manufacturing quality system.

To support the expanding commercial pipeline and enhance global supply resilience, the Group continues to advance its "Global Dual Sourcing" strategy, scaling integrated CRDMO capabilities across geographies, while expanding its manufacturing footprint globally.

U.S.: Construction of MFG11 in Worcester, MA is progressing. Upon completion, the facility will feature six 6,000L single-use bioreactors, a dedicated downstream line, and extensive automation. MFG18 in Cranbury, NJ is also being upgraded to add commercial manufacturing capabilities in response to the strong local demands.
Singapore: Construction of a new modular drug product (DP) facility has commenced and is expected to be one of the largest modular biologics DP facilities globally, significantly enhancing the Group’s end-to-end DP service capabilities. The design of a modular drug substance (DS) facility is also underway. In addition, WuXi XDC’s Singapore site achieved mechanical completion in June 2025.
Qatar: In December 2025, the Group signed a MOU with the Qatar Free Zones Authority (QFZ), advancing plans to establish the Qatar site as a strategic hub within its global CRDMO network and extend its geographic presence into the Middle East.

Backlog
As of December 31, 2025, total backlog stood at US$23.7 billion, including US$11.5 billion service backlog and US$12.2 billion potential milestones. Backlog within 3 years reached US$4.5 billion, providing strong visibility into near-term revenue growth.

Quality
The Group maintains a comprehensive global quality management system to support clients’ regulatory and compliance requirements. From 2017 to 2025, the Group has completed 46 regulatory inspections by major national authorities, including 22 by the U.S. FDA and EU EMA, with no critical issues and zero data integrity findings.

As of December 31, 2025, the Group maintains a 100% pass rate for FDA Pre-License Inspection (PLI) and has passed more than 1,800 client GMP audits, including 230+ conducted by EU Qualified Persons, demonstrating consistent quality and compliance standards across global operations.

(Press release, WuXi Biologics, MAR 24, 2026, View Source [SID1234669264])

On March 24, 2026 Propanc Biopharma, Inc. (Nasdaq: PPCB) ("Propanc" or the "Company"), a biopharmaceutical company focused on developing novel treatments for chronic diseases, including recurrent and metastatic cancer, reported that a multi-year Joint Research Collaboration Agreement has been established with the Universities of Jaén (UJA) and Granada (UGR), Spain. This is the fifth agreement between Propanc and the universities over a seventeen-year period resulting in four patent families being filed, five peer reviewed publications accepted, numerous scientific presentations delivered, as well as two PhD’s and a professorship awarded to members of the Universities’ research team members.

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The collaboration involves the evaluation of a senescence-modulating (i.e., anti-aging) compound to mitigate senescence and to complete experiments to further support the claims of recently filed fibrosis and cancer related patent applications, requested by Propanc Biopharma Inc. to the research group "Biological Technologies of The University of Jaén" and UGR’s Research Group, "Advanced Therapies: Differentiation, Regeneration and Cancer."

Prof. Macarena Perán Quesada, University of Jaén, will oversee management and coordination functions of the working team and will be the scientist in charge of the project appointed by the university. Two Postdoctoral Fellows of the UJA, Dr Maria Belén Toledo and Dr Aitor González-Titos will conduct the study, including in vitro and in vivo experiments, data analysis, and manuscript preparation.

Prof. Juan Antonio Marchal Corrales, head of the Laboratory in Bio-fabrication and 3D-bioprinting of the University of Granada will oversee management of equipment and facilities necessary to perform in vitro and in vivo experiments and will be the scientist in charge of the experimental designs and project by the university.

"As we enter an exciting phase for the Company advancing our lead asset, PRP to a Phase 1b, First-In-Human study in advanced cancer patients this year, we are delighted to strengthen our collaboration with our partner universities, specifically Professors Quesada and Marchal and the research team. Over the next two years, our goal is to strengthen our intellectual property and to better understand how PRP technology can overcome numerous resistant tumors, and additionally, rejuvenate cells to overcome age-related, chronic diseases, such as fibrosis," said Mr. James Nathanielsz, Propanc’s Chief Executive Officer. "The market potential of PRP is significant and of a high degree of interest among the scientific community. As we transform into a clinical-stage R&D Company we look forward to possible major discoveries that broadens the therapeutic potential of PRP in several life-threatening diseases based on cell and tissue rejuvenation."

(Press release, Propanc, MAR 24, 2026, View Source [SID1234663870])