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 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])

On March 24, 2026 Calidi Biotherapeutics, Inc. (NYSE American: CLDI) ("Calidi" or the "Company"), a biotechnology company pioneering the development of targeted genetic medicines, reported a partnership with Avance Clinical, a full-service contract research organization (CRO) with a proven track record and experience in obtaining regulatory approval and clinical trial initiation in Australia. The partnership is focused on rapidly initiating a first-in-human clinical trial for CLD-401 in Australia. In parallel, the Company will pursue an IND filing with the FDA in 2026.

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CLD-401 is a genetically modified form of vaccinia virus that is systemically delivered, replicates only in tumor cells, and expresses high levels of IL-15 superagonist (IL-15 SA), an activator of innate and adaptive immune response, in the tumor microenvironment. The planned phase I will investigate the safety, pharmacodynamics, and efficacy of CLD-401 given as monotherapy in patients with solid tumors that have exhausted all other therapeutic options.

"We believe CLD-401 represents a unique mechanism of action in oncology," said Eric Poma, PhD, Chief Executive Officer of Calidi. "We are excited to work with Avance Clinical to initiate clinical studies as quickly as possible and bring this potential treatment option to patients whose disease is resistant to current therapies."

Calidi is currently conducting IND-enabling studies with CLD-401, the first lead candidate from its RedTail platform. The Company continues to expand the functionality of the RedTail platform and is also actively pursuing strategic partnerships to accelerate clinical development and broaden the impact of its RedTail platform.

(Press release, Calidi Biotherapeutics, MAR 24, 2026, View Source [SID1234663886])

On March 24, 2026 Akeso, Inc. (9926.HK) ("Akeso" or the "Company") reported that it has received clearance from the Center for Drug Evaluation (CDE) of China’s National Medical Products Administration (NMPA) to initiate Phase II clinical trials for AK146D1, a first-in-class Trop2 /Nectin4 bispecific antibody-drug conjugate (ADC), and AK138D1, an innovative HER3-targeting ADC.

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The studies will evaluate these two novel ADC candidates in combination with the Company’s pioneering immuno-oncology (IO) 2.0 bispecific antibodies, cadonilimab (PD-1/CTLA-4) and ivonescimab (PD-1/VEGF), as well as other proprietary high-potential anti-tumor assets, including AK117 (anti-CD47 monoclonal antibody) and AK109 (anti-VEGF monoclonal antibody), across a spectrum of advanced solid tumors. This milestone marks a strategic acceleration of Akeso’s proprietary "IO 2.0 + ADC 2.0" combination platform into mid-stage clinical development.

These Phase II studies will leverage the cadonilimab and ivonescimab as foundational backbone therapies, capitalizing on their validated clinical profiles in checkpoint blockades and dual VEGF/PD-1 inhibition. The regimens center on Akeso’s internally discovered next-generation ADCs while exploring synergies with the company’s broader internal portfolio.

The convergence of immuno-oncology and ADC modalities has emerged as a high-conviction frontier in oncology therapy, offering the potential to overcome the limitations of monotherapy approaches – such as antigen escape, heterogeneous expression, and narrow therapeutic indices. Akeso holds a distinct global competitive advantage as the only company with two approved cancer immunotherapy checkpoint bispecific antibodies. By pairing these IO backbones with next-generation ADC candidates like AK146D1 and AK138D1, the Company is driving the next generation of combination therapy. AK146D1 and AK138D1 have been specifically designed to expand the therapeutic window and mitigate safety-related limitations of traditional ADCs. The progression of these "IO 2.0 + ADC 2.0" combinations into Phase II development is a significant step in establishing Akeso’s next-generation leadership in the global oncology landscape.

AK146D1 is a first-in-class bispecific ADC engineered to simultaneously target Trop2 and Nectin4, antigens that are frequently co-expressed in epithelial-derived malignancies such as lung, breast, and bladder cancers. This dual-targeting approach is designed to enhance selectivity, address tumor heterogeneity, and overcome the resistance mechanisms common in single-target ADC therapies. AK138D1 is a next-generation ADC targeting HER3, a receptor associated with tumor progression and resistance to established EGFR and HER2 treatments in various malignancies, including ovarian, colorectal, melanoma, and prostate cancers. Early-stage data for both AK146D1 and AK138D1 have demonstrated potent anti-tumor activity and a highly manageable safety profile.

Akeso continues to extend its global IO 2.0 leadership into broader, high-impact combination strategies. Beyond the "IO 2.0 + ADC 2.0" portfolio, the Company is advancing a comprehensive portfolio of novel combination approaches aimed at addressing major unmet clinical needs. These include IO 2.0 combinations with other immune checkpoint inhibitors (ICIs), mRNA-based personalized cancer vaccines (such as AK154), DNA-based therapeutics, and additional novel therapeutic platforms.

This milestone underscores Akeso’s disciplined execution in translating proprietary platform synergies into clinical progress, positioning the Company at the forefront of next-generation global oncology innovation.

(Press release, Akeso Biopharma, MAR 24, 2026, View Source;adc-2-0-strategy-with-phase-ii-initiation-of-novel-adcs-combined-with-ivonescimab-and-cadonilimab-302724222.html [SID1234663872])