Announcement • Apr 02
Bioxytran, Inc. announced delayed annual 10-K filing On 04/01/2026, Bioxytran, Inc. announced that they will be unable to file their next 10-K by the deadline required by the SEC. Announcement • Mar 06
Bioxytran Inc Announces Positive Dose Optimization Results And Advances Toward Phase 3 Registrational Trial For ProLectin-M Bioxytran, Inc. announced positive dose optimization results for its lead antiviral candidate, ProLectin-M, and provided an update on the Company’s planned Phase 3 registrational trial. The data, released March 2, 2026, were designed to establish the optimal dosing strategy and support advancement into a pivotal study intended to enable full regulatory approval. Bioxytran has entered regulatory discussions with the U.S. Food and Drug Administration (FDA) and India’s Central Drugs Standard Control Organization (India regulator) to finalize the design of a Phase 3 registrational trial. Planned key elements include: Study Size: Approximately 408 participants; Design: Randomized, placebo-controlled, outpatient study; Primary Endpoint: Statistically significant viral clearance or clinical improvement by Day 5 compared to placebo; Target Population: Standard-risk patients with mild-to-moderate COVID-19 and other viral infections from Influenza, RSV and other viruses. The Company intends for the Phase 3 trial to serve as the final clinical step toward potential regulatory approval. The recently completed 39-participant study confirmed that a 16,800 mg/day dosing regimen achieved 90% viral clearance by Day 5 while maintaining a favorable safety profile. Earlier development stages evaluated lower dose levels. The March 2 data identified 16,800 mg/day as the optimal balance between antiviral activity and tolerability, providing clarity as the Company advances into Phase 3 planning. ProLectin-M utilizes a novel galectin-blocking mechanism designed to interfere with viral entry into host cells. This approach differs from replication inhibitors such as Paxlovid, developed by Pfizer, which target viral proteases after infection has occurred. Bioxytran is also evaluating the broader antiviral potential of its galectin antagonist platform. On February 23, 2026, the Company initiated a research collaboration with the University of Georgia to evaluate its compound (PHM23) against H5N1 avian influenza strains as part of a federally supported initiative aimed at mitigating poultry losses. In addition, in vitro studies have demonstrated viral load reduction against RSV and H1N1 influenza strains. The Company is also advancing ProLectin-I, an intravenous formulation, for investigation in Long COVID. With dose optimization complete and regulatory engagement underway, Bioxytran believes it has established the scientific and clinical foundation necessary to proceed into a pivotal Phase 3 registrational trial. The Company will provide additional updates as regulatory discussions progress and timelines are finalized. Announcement • Feb 11
Bioxytran, Inc. Reports Positive Phase 2 Results Demonstrating Rapid Viral Clearance with Prolectin-Mbioxytran Bioxytran, Inc. announced positive clinical results from its recently completed Phase 2 randomized, double-blind, placebo-controlled, dose-optimization trial evaluating ProLectin-M in subjects with laboratory-confirmed acute viral infection. The Bioxyytran Trial reports complete elimination of viral load in 100% of patients at day 7 versus placebo (p=0.001). The completed Phase 2 clinical study was a randomized, double-blind, trial evaluating orally administered ProLectin- M in subjects with acute viral infection. The study enrolled 38 subjects, all of whom completed the study. Subjects were randomized to receive one of three ProLectin-M dose levels or a matching placebo, administered over a seven-day treatment period. Viral shedding was assessed using RT-PCR analysis of nasopharyngeal swabs collected at predefined timepoints, with viral clearance defined as non-detection of viral RNA below established PCR thresholds. The study design, endpoints, and duration confirmed Bioxytran's earlier randomized, placebo-controlled Phase 2 trial, which demonstrated statistically significant reductions in viral load by Day 7, early clearance as soon as Day 3, and no observed viral rebounds during a 14-day post-treatment observation period. The current trial further refined dose selection of four tablets per day and evaluated the reproducibility of rapid viral clearance using the same core virologic assessment methodology. Following database lock and unblinding, treatment-wise analyses demonstrated the following outcomes: Complete elimination of viral load in100% of treated subjects by Day 7, compared to the placebo group (p= 0.001); No viral rebounds observed in the treated population during the 14-day post-treatment observations period. These results indicate rapid and sustained viral clearance in subjects treated with ProLectin-M. Viral Clearance Timing (All Subjects) Across the full study population: Day 3: 1 of 38 subjects demonstrated non-detection of viral shedding; Day 5: 16 of 38 subjects demonstrated non- Detection of viral shedding; Day 7: 38 of 38 subjects demonstrated non- detection of viral shedding. The study was designed to evaluate viral clearance kinetics and inform dose selection for future late-stage clinical development. "What continues to distinguish ProLectin-M as a broad-range antiviral drug is its novel mechanism of action," Dr. Platt continued. " Rather than targeting viral replication inside the cell, our galectin antagonist is designed to interfere with viral entry at the cell surface. This extracellular approach may reduce reliance on immune activation and represents a fundamentally different strategy in antiviral therapy. We believe these results further support the potential of carbohydrate-based therapeutics and the emerging field of Glycovirology". Next steps: Based on these results, Bioxytran plans to advance regulatory discussions to support late-stage clinical development and evaluate ProLectin-M across additional viral indications consistent with its broad-spectrum antiviral profile. 
