Annonce • 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. Annonce • 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. Annonce • 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. Annonce • Oct 29
Bioxytran Completes Randomized Clinical Trial for Its Broad-Spectrum Antiviral Drug Bioxytran, Inc. announced the successful completion of its second randomized double-blind, placebo-controlled clinical trial for its leading broad-spectrum antiviral drug candidate, ProLectin-M. Data from the trial is expected to inform both the CDSCO for a phase 3 trial design and will also be submitted to the FDA pursuant to their request. This second randomized controlled trial was designed to confirm the results from the Company's earlier Phase 2 study, which demonstrated that ProLectin-M achieved undetectable levels of Polymerase Chain Reaction (PCR) and infection in less than one week in treated participants. The successful execution of this third independent trial significantly strengthens the robust evidence for ProLectin-M's potential as a rapid-acting oral therapeutic for a wide range of viral infections. The comprehensive data from this third clinical trial, including detailed safety and efficacy endpoints, is expected to be compiled for publication in a peer-reviewed medical journal. The company anticipates that the full results will be submitted for publication in the coming weeks. Annonce • Aug 16
Bioxytran Unveils Revolutionary Precision Diagnostics on Tissue Oxygenation Bioxytran, Inc. announced a major scientific milestone: the publication of Body Oxygen Homeostasis and Mitochondrial Function from Animal Models to Clinical Applications by Prof. Avraham Mayevsky, a key advisor to Bioxytran. This work dives deep into the science of oxygen regulation and mitochondrial health - revealing transformative insights that could redefine treatment for stroke, Alzheimer's, and other critical conditions. Current medical practices rely on outdated peripheral oxygen measurements, often missing the real crisis happening inside vital organs. Imagine a stroke patient with "100% oxygen saturation" while their brain suffering--this is the alarming gap that Prof. Mayevsky's research addresses. His book bridges cutting-edge animal studies with real-world clinical applications, offering a roadmap to Precision diagnostics. The book highlights how shifting from peripheral to tissue-specific oxygenation monitoring (via FDA-approved tools like the MDX Viewer) leads to better outcomes in the operating room. This Next-gen diagnostic is aligned with Bioxytran's Universal Oxygen Carrier (UOC), designed to rescue oxygen-starved tissues in stroke and neurodegenerative diseases. Bioxytran is integrating these insights into its upcoming BXT-25 clinical trials, aiming to prove that targeted oxygen delivery can rescue damaged tissues--and potentially rewrite treatment paradigms. This technology will serve as a biomarker capable of advancing the clinical trials of BXT-25 because it is a powerful way to measure oxygen consumption of the brain during stroke. Annonce • Aug 07
Bioxytran's Breakthrough Broad-Spectrum Antiviral Technology Poised to Revolutionize Respiratory Infection Treatment Bioxytran, Inc. announced significant progress in development of its broad-spectrum antiviral drug, ProLectin-M. The company has successfully completed dosing of its dose optimization clinical trial, bringing it one step closer to introducing a oral antiviral that could redefine the treatment landscape for respiratory infections, potentially reducing the need for traditional vaccinations. ProLectin-M, Bioxytran's leading drug candidate, targets the galectin fold on the spike proteins of viruses such as SARS-CoV-2, influenza, and respiratory syncytial virus (RSV). Peer-reviewed published studies have demonstrated its ability to neutralize these viruses with high efficacy, achieving a complete response (negativePCR tests) in all subjects by day 7 and an 88% response rate by day 3 in double blinded placebo controlled clinical trials, with no viral rebounds during the 14-day observation period. The recent completion of enrollment in the dose optimization trial, of a second randomized double-blind placebo-controlled study, marks a critical milestone in refining the drug's dosing strategy to maximize efficacy and safety. Annonce • May 21
Bioxytran's Antiviral Breakthrough Featured in University of Georgia's $100 Million Hpai Poultry Innovation Grand Challenge Submission Bioxytran, Inc. announced that the University of Georgia confirmed the antiviral PHM23 was to be included amongst other drug candidates in the Universities grant submission to the U.S. Department of Agriculture's (USDA) $100 million Highly Pathogenic Avian Influenza (HPAI) Poultry Innovation Grand Challenge. This prestigious recognition highlights PHM23's potential as a solution to combat Bird Flu (H5N1) and underscores its broad-spectrum antiviral activity. The University of Georgia is a world leader in poultry health. The selection of this molecule demonstrates how PHM23 stands out in the antiviral space as a promising therapeutic candidate capable of neutralizing viral infections. Inclusion in this high-profile submission is expected to amplify awareness of the antiviral activity of Bioxytran's molecule. By targeting galectins--proteins critical to viral replication--PHM23 has demonstrated effectiveness against viruses similar to Bird Flu in vitro studies, positioning it as an antiviral candidate for addressing multiple viral threats. Bioxytran's galectin antagonist technology, embodied in PHM23, works by blocking viral spike proteins from approaching to host cells, a mechanism conserved across mammals that minimizes the risk of viral mutations. This approach offers hope for rapid containment of H5N1 outbreaks, potentially eliminating the need for mass culling and mitigating billions in annual losses to the poultry industry. The USDA's HPAI Poultry Innovation Grand Challenge, with up to $100 million in funding, aims to curb the spread of Bird Flu, protect U.S. poultry farmers, and ensure food security. Bioxytran is actively seeking partnerships with academic, industry, and government stakeholders to accelerate PHM23's development and deployment in response to this urgent global need. Annonce • May 12
Bioxytran, Inc. Completes Dose Optimization of Antiviral, ProLectin-M Bioxytran, Inc. announced the successful completion of the dose optimization of its antiviral drug ProLectin-M in a randomized double-blind placebo-controlled trial. Preliminary results are expected, with full data submission to the FDA under Bioxytran's active Investigational New Drug (IND) clinical trials for ProLectin-M. Key Trial Details: Evaluated multiple ProLectin-M doses vs. placebo over 5 days; Primary Endpoint: Undetectable viral load by Day 7; Secondary Endpoints: Early viral clearance (Days 3 & 5); Symptom improvement (WHO Clinical Progression Scale); Safety/tolerability profile. Strategic Implications: Data will inform additional trials design for potential COVID-19, Influenza, RSV, EBV viral indications; Supports FDA and Central Drugs Standard Control Organization (CDSCO) submissions per agency request; Builds on prior trials showing: 100% responder rate (negative PCR) by Day 7; 88% responder rate by Day 3. Annonce • Apr 01
Bioxytran, Inc. announced delayed annual 10-K filing On 03/31/2025, Bioxytran, Inc. announced that they will be unable to file their next 10-K by the deadline required by the SEC. Annonce • Mar 12
Bioxytran, Inc. Develops Treatment to Combat Bird Flu in Egg Laying Chickens Potentially Saving Billions Bioxytran, Inc. unveiled a potential game-changer in the fight against Highly Pathogenic Avian Influenza (HPAI), commonly known as Bird Flu. This innovative water-soluble galectin antagonist, currently in preclinical trials, could revolutionize how outbreaks are managed in egg-laying chickens, preventing mass culling and safeguarding the global food supply. Bioxytran's treatment leverages galectin antagonists, a class of molecules designed to block viral entry into cells, by neutralizing the virus in egg-laying chickens. This approach could prevent the spread of H5N1 without the need for mass culling, a current requirement during outbreaks. Galectin antagonists have shown their ability to block viral adhesion. This has been proven in Phase 2 human clinical trials and in vitro tests. The Company thinks this mechanism works the same in all mammals. This is the reason why the Company expects it to be very effective in chickens. While the Company is also working on establishing the optimal delivery method, it is actively seeking partnerships with organizations and government agencies to accelerate the development and deployment of this treatment. Annonce • Jul 05
Bioxytran, Inc. Announces BXT-25 Drug Acts as a Universal Oxygen Carrier Like Hyperbaric Oxygenation for Stroke & Alzheimer's Patients Bioxytran, Inc. announced that Bioxtran's Science Advisor Prof. Avraham Mayevsky's book titled Hyperbaric Oxygenation Mitochondrial Activity and Brain Physiological Functions was published by a publishing house, Springer. It is available by eBook or Hardcover. The book is directly tied to the Hypoxia platform technology which uses the MDX Viewer as an analytical method, which is an FDA approved device to measure tissue oxygenation. The device measures the consumption of oxygen molecules in tissues on a cellular level. The output of the MDX Viewer is the Brain Metabolic Score BMS, which is a vital part of the approval process for Bioxytran's acellular oxygen carrier (AOC) molecule called BXT-25. Bioxytran plans on using the BXT-25 in its clinical trials for ischemic stroke and Alzheimer's disease patients as a way to replace hyperbaric oxygen treatment (HBOT). The book is a comprehensive overview of the effects of hyperbaric oxygen on brain functions including mitochondrial activity. The MDX viewer is an FDA approved medical device that measures tissue metabolic score and its results are cited many times throughout the book. The results from the MDX viewer provided a solid foundation upon which he was able to further elucidate the relationship between oxygenation and cerebral function with respect to hyperbaric oxygen treatment. The book also discusses the effects of hyperbaric air treatment on brain biochemical and physiological responses that can influence mitochondrial activity, which is essential for energy production. The evidence suggests that hyperbaric oxygen improves cerebral blood flow and tissue oxygenation which ultimately results in a positive impact on brain functioning and performance. Annonce • Mar 06
Bioxytran, Inc. Announces Preprint of Shingles Case Study Showing Clearance Using A Topical Galectin-3 Antagonist Bioxytran, Inc. announced the preprint in ResearchGate entitled “Association of Rapid Shingles Lesion Clearance and Regression of Herpes Zoster Neuralgia in Case Study Using Topical Galectin-3 Antagonism” showed a time lapsed clearance of the shingles lesions using a topical Galectin-3 antagonist. Vaccines have been developed to prevent shingles, but there are few effective antiviral therapies capable of treating the outbreak while reducing the pain associated with the condition. The case study demonstrated a rapid response in the reduction of pain the size of the lesion area, due to a galectin antagonist. Annonce • Feb 22
Bioxytran, Inc.'S Oral Antiviral Drug to Enter Dose Optimization Clinical Trial for Covid-19 Bioxytran, Inc. announced that the first patients have been treated with ProLectin-M in its dose optimization trial. ProLectin-M is intended to become a first line treatment for standard risk COVID-19 patients, but based on the broad-spectrum in vitro discovery could easily expand to upper respiratory tract infections. Following this dose optimization trial, Bioxytran intends to use the trial data to inform the design of the Phase 3 registrational trial in India, while also adhering to the FDA’s request for additional data. The multi-center clinical trial in India will be a randomized double-blind placebo-controlled trial and is set to enroll 40 patients. ProLectin-M has previously established efficacy in two, previously conducted, peer-reviewed clinical trials with a 100% responders rate in both trials and p-values of .05 and .001. In the past decade only one other antiviral has, to its knowledge, achieved a similar preliminary efficacy profile. The Company has already established the non-toxic profile of its galectin antagonists. Official additional studies are anticipated and planned in the United States. Annonce • Aug 25
Bioxytran, Inc. Receives Clearance of its Investigational New Drug Application from U.S. Food and Drug Administration to Initiate Clinical Trials of ProLectin-M Bioxytran, Inc. announced that it has received clearance of its Investigational New Drug (IND) application from the U.S. Food and Drug Administration (FDA), to initiate clinical trials of ProLectin-M for the treatment of mild to moderate COVID-19 in standard risk patients. Annonce • Feb 08
Bioxytran, Inc. Receives Approval to Initiate Trials with Prolectin-I Bioxytran, Inc. announced the receipt of an Investigational New Drug (IND) authorization letter from India’s Central Drugs Standard Control Organization (CDSCO) to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of ProLectin-I injection. The objective of this trial is to provide guidance for future Phase II trial in Long COVID and Idiopathic Pulmonary Fibrosis (IPF). This is a separate and additional approval from the authorization that ProLectin-M received on December 2, 2022. ProLectin-I is an intravenous new chemical entity drug that is expected to treat Long COVID and Idiopathic Pulmonary Fibrosis (IPF). Long COVID is estimated to have 65 - 100 million cases worldwide. The CDC believes it affects one in five people that contract COVID-19. According to Harvard University, the economic cost of Long COVID is $3.7 trillion in the just the United States. IPF affects approximately 3 million people worldwide. The disease primarily affects patients over the age of 50 and affects more men than women. The top theory behind the pathogenesis of Long Covid is viral persistence or viral fragments. ProLectin-I binds to the 'galectin fold' of the spike protein thereby neutralizing a replication competent viruses' ability to infect other cells, but it also binds to spike protein fragments thought to be the cause of ongoing inflammation. The medical term for scar tissue is fibrin. The word fibrosis stems from the continued growth of fibrin. Once scar tissue forms in the lungs combined with an already suppressed immune system, scar tissue can start to spread quickly. The reason for scar tissue forming in the lungs can vary, but it can always be associated with the onset of lung damage. Combining lung damage with an impaired immune system leads to scar tissue forming in the lungs. Multiple galectin types are associated with fibrosis, and ProLectin-I is thought to bind to a few. Annonce • Dec 30
Bioxytran, Inc. Announces Crystal Research Update Highlights 100% Responders Rate in Mild to Moderate COVID-19 Trial Bioxytran, Inc. announced that Crystal Research provided an update on BIXT. Crystal research reported that the Company announced positive topline safety and efficacy results from its randomized, placebo-controlled Phase 2 clinical trial in 34 patients with mild-to-moderate COVID-19. During the 7 days of treatment, an orally administered Galectin Antagonist in the form of a chewable tablet was administered 8 times per day on an hourly basis. The trial met its endpoint with a 100% response rate by day 7 versus 6% in placebo, which was statistically significant (p-value=.001) and something that has only ever been accomplished by one other drug in the past decade. The Company’s analysis also revealed an 88% response rate by day 3, which was statistically significant (p-value=.001). During the quarter the company also announced its receipt of an Investigational New Drug (IND) authorization letter from India’s Central Drugs Standard Control Organization (CDSCO) to optimize dosage in COVID-19 patients. The trial’s objective is to provide guidance for a 408 patient Phase III trial that will be finalized after analyzing the data from the optimization trial. The Company also announced that it had established an Indian subsidiary (Pharmalectin India Private Limited), with a purpose to launch commercial product sales of ProLectin-M should the company receive Central Drugs Standard Control Organization (CDSCO) approval. The Indian manufacturing plant is an FDA-approved facility that is capable of supporting the Indian market with a population of 1.4 billion people. The update also covered the mechanism of action (MOA) detailed in the latest pre-print in greater depth. Nuclear Magnetic Resonance testing was used to elucidate the Mechanism of Action of the specific Galectin Antagonist. Tests concluded that ProLectin-M (PL-M) binds relatively strongly to Galectin-3 with high micromolar affinity. While the galectin antagonist does indeed bind to the S1 Spike Protein, the study showed that it could bind in 2 different orientations. The Nuclear Magnetic Resonance (NMR) binding data was so precise that it measured 5 molecules of Galectin-3 were need to neutralize 1 spike protein. This finding demonstrated 5 binding sites for the Galectins. The final experiment revealed that Lactose which is a common sugar that ingest competes with Galectin-3. These findings on the mechanism of action helped inform the decisions on dosing, duration, and ingestion. Annonce • Dec 10
Bioxytran Receives Approval to Optimize Dosage in Covid-19 Patients BIOXYTRAN, INC. announced the receipt of an Investigational New Drug (IND) authorization letter from India’s Central Drugs Standard Control Organization (CDSCO) to optimize dosage in Covid-19 patients. The trial’s objective is to provide guidance for a 408 patient Phase III trial. Annonce • Nov 17
BIOXYTRAN, INC. Releases Positive Top-line Results from Phase 2 Trial of Galectin Antagonist on COVID-19 Patients in medRxiv Pre-print BIOXYTRAN, INC. announced positive topline safety and efficacy results of its randomized, placebo-controlled Phase 2 clinical trial in 34 patients with mild-to-moderate COVID-19. During the 7 days of treatment, an orally administered Galectin Antagonist in the form of a chewable tablet was administered 8 times per day on an hourly basis. The endpoint was a statistically significant reduction in viral load measured by the number of patients reaching a below threshold PCR value (Ct value = 29) by day 7. The trial met its endpoint with a 100% response rate by day 7 versus 6% in placebo, which was statistically significant (p-value = .001). the analysis also revealed an 88% response rate by day 3, which was statistically significant (p-value = .001). There were no drug-related serious adverse events (SAE's) in the patient population or viral rebounds by day 14 in the patient population. The positive data from this clinical trial provided the rationale of dosing and protocol design for study in an upcoming phase 2/3 registrational trial. Nuclear Magnetic Resonance ("NMR") testing was used to elucidate the Mechanism of Action of the specific Galectin Antagonist. Tests concluded that ProLectin-M ("PL-M") binds relatively strongly to galectin-3 with micromolar affinity down to 2µM. While the Galectin Antagonist does indeed bind to the S1 Spike Protein, the study showed that it could bind in 2 different orientations with galectin-3. The NMR binding data indicate that 5 molecules of galectin-3 are required to saturate one spike protein. These findings on the mechanism of action supported the decisions on dosing, duration, and ingestion. The results showed PL-M's inhibition of galectin-3 and the blockade of the N-Terminal Domain of the S-1 subunit. Annonce • Aug 17
Bioxytran, Inc. announced that it has received $0.6 million in funding Bioxytran, Inc. announced that it will receive $600,000 in funding on August 16, 2022. The company will issue common shares in the transaction. The company will issue securities pursuant to exemption provided under Regulation D. The minimum investment accepted from any outside investor is $600,000.
On August 16, 2022, Bioxytran, Inc. closed the transaction. The transaction included participation from single investor. Annonce • May 17
Bioxytran, Inc. announced delayed 10-Q filing On 05/16/2022, Bioxytran, Inc. announced that they will be unable to file their next 10-Q by the deadline required by the SEC. Annonce • Mar 30
Bioxytran, Inc. announced delayed annual 10-K filing On 03/29/2022, Bioxytran, Inc. announced that they will be unable to file their next 10-K by the deadline required by the SEC.