BIOXYTRAN, INC
For the period ended Dec 31, 2025. Filed Apr 15, 2026.
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FY2025 · Filed Apr 15, 2026
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Item 1. Business
GENERAL ORGANIZATION AND BUSINESS
Bioxytran, Inc. is a clinical stage pharmaceutical company developing platform technologies in the fields of Glycovirology, Hypoxia and Degenerative Diseases to eliminate viruses and prolong lifespan using carbohydrate drug design.
We were incorporated on June 9, 2008, as America’s Driving Ranges, Inc.. On September 21, 2018, the Company was reorganized into Bioxytran through a reverse merger to focus on the development, manufacturing and commercialization of therapeutic drugs designed to address Hypoxia and Degenerative Diseases and antiviral treatment in humans. Our principal executive offices are located at 75 2nd Avenue, Needham, MA 02494. There are four wholly owned subsidiaries specialized in specific aspects of the business.
Pharmalectin, Inc. (the “Pharmalectin”) is a subsidiary focused on the development, manufacture and commercialization of therapeutic drugs designed to address conditions related to viral diseases.
NDPD Pharma, Inc. (the “NDPD”) is a subsidiary focused on prototyping and development of specialized equipment for pharmaceutical manufacturing, and in the development of carbohydrate molecules deriving from partially hydrolyzed guar gum (“PHGG”).
Pharmalectin (BVI), Inc. (the “Pharmalectin BVI”) is a subsidiary serving as custodian of the Company’s Copyrights, Trademarks and Patents.
Pharmalectin India Pvt Ltd. (the “Pharmalectin India”) is a subsidiary managing the Company’s local clinical research and trials, and holds the local rights to commercialization in India.
Platform Technologies
Bioxytran uses Galectin inhibitors to combat the virus, SARS-CoV-2. The technology is built on the lifetime work of company’s founder, David Platt, PhD. Dr. Platt expressed (identified), and named, the Human Galectin-3 protein coded by a single gene, LGALS3, located on chromosome 14. Galectin inhibitors block the binding of galectins to carbohydrate structures, present in numerous disease indications calming the body’s overactive inflammatory response that makes chronic diseases worse. The galectin inhibitors also have the capability to neutralize the spike proteins of a number of viruses which reduces their capability to replicate. Dr. Platt has over the years used this knowledge to create a significant number of sustainable therapeutic solutions. Bioxytran is also developing treatments for hypoxic conditions, necrosis, and degenerative diseases that utilize the carrying of oxygen to affected areas for stroke, wound, and brain damage treatment.
a. Glycovirology
Glycovirology is a novel glycan-based platform technology. The concept involves using sugar-based drugs to block viruses. They work by latching onto the virus’s binding site, which prevents the virus from attaching to and entering our healthy cells. Researchers have also found that these carbohydrate drugs can help regulate the immune system. Moving forward, scientists will likely refine these drug candidates to better target the stable, common parts of the virus—the areas that don’t mutate or change easily.
The efficacy of the lead candidate (the “ProLectin-M”, or the “PL-M”) a molecule based on Partially Hydrolyzed Guar Gum (the “PHGG”) was evaluated in a randomized, double-blind, placebo-controlled clinical study in patients with mild to moderately severe COVID-19. Primary endpoints included changes in the absolute RT-PCR Ct values of the nucleocapsid and open reading frame (ORF) genes from baseline to days 3 and 7. On day 3, 14 subjects in the PL-M group had cycle counts for the N gene above the cut-off value of 29 (target cycle count 29), whereas on day 7, all subjects had cycle counts above the cut-off value. Ct values in placebo subjects were consistently less than 29, and no placebo subjects were RT-PCR-negative until day 7. Most of the symptoms disappeared completely after receiving PL-M treatment for 7 days in more patients compared to the placebo group. The results were published in the journal Virus on February 23, 2023 under the title “An Oral Galectin Antagonist in COVID-19—A Phase II Randomized Controlled Trial”, DOI: 10.3390/vaccines11040731.
Galectin Antagonist Benefits
| ● | Eliminates virus: Galectin Antagonist shows a rapid reduction of viral load in the blood and eliminates the virus completely within a few days. The theory behind the Mechanism of Action (MOA) is that the drug prevents the virus from entering the human cell and is eventually eliminated by the liver. |
| ● | Stops the spread: If Galectin Antagonist reduces the viral load quickly enough it has the potential to get to viral levels that are considered non-contagious. Lowering viral levels can also lower the infectivity of the virus and help prevent people from spreading the virus to others by reducing the time that they are contagious whereas vaccinated people can still infect others. |
| ● | Promotes immunity: The adaptive immune system creates Immunoglobulin G (IgG) antibodies resulting in long term immunity. |
| ● | Prophylactic characteristics: If Galectin Antagonist can slow the spread of the virus to other parts of the body, then it gives rise to the possibility that people who are not infected by the virus might be able to use Galectin Antagonist as a preventative measure. |
| ● | Universally compatible with all mutations: By targeting lectins, which are located on the most conservative part of the spike protein, Galectin Antagonist binds to the part of the spike protein resistant to change regardless of how the SARS-CoV-2 mutates. |
| ● | Easy to transport and administer: Galectin Antagonist tablets can be stored at any temperature. They are easy to administer and people can treat themselves at home. |
Bioxytran has an Investigational New Drug application (an “IND”) approved by the FDA under the title “PROTECT: PROlectin-m, a nucleocapsid TErminal galeCTin antagonist for COVID-19 (PROTECT), a Randomized, Double-blinded Clinical Trial to Evaluate the Efficacy and Safety in Non-Hospitalized Adult Participants with COVID-19”
Further, the Company has an IND issued by India’s Central Drugs Standard Control Organisation (the “CDSCO”) with permission to conduct: “A Phase 1b/2a Randomized, Blinded, placebo-controlled Study in Participants with Mild to Moderate COVID-19 to Evaluate the Safety, Efficacy, and Pharmacokinetics of Orally Administered ProLectin-M”.
b. Hypoxia and Degenerative Diseases
Bioxytran is developing an innovative platform of oxygen therapeutic treatments for hypoxic conditions and necrosis prevention. Our initial targeted medical conditions are brain stroke, wound healing, and trauma. Most of these disease indications can use hyperbaric treatment, but that form of treatment is costly and limited. In these indications hyperbaric treatment shows promise, but the duration of treatment is limited due to oxygen toxicity our oxygen transport molecule has the ability to impact the duration of treatment due to its drug design. A hyperbaric chamber can only be used for a short time and can develop free radicals in the blood and typically a treatment lasts 1 hour. In theory our transport molecule will deliver the right kind of oxygen and not develop any free radicals known to cause oxygen toxicity.
| ● | Delivering less free radicals and right type of oxygen (the “O2”) |
| ● | Deliver longer treatment regimens |
Oxygen is indispensable to the life of all human tissues. Hemoglobin, a protein normally contained within red blood cells, is the molecule responsible for carrying and releasing oxygen to the body’s tissues. Hemoglobin’s protein structure is similar in many different animal species, including humans. Under normal conditions, hemoglobin contained within red blood cells carries approximately 98% of the body’s oxygen and the remaining two percent is dissolved in the plasma, or the liquid part of the blood.
Our solution is an Acellular Oxygen Carrier (the “AOC”), which molecules hold the same amount of oxygen as the hemoglobin molecules in Red Blood Cells (the “RBC”). The AOC molecule contains a co-polymer to stabilize the cross- linked subunits of hemoglobin protein as a universal carrier for oxygen. It is delivered as an injectable intravenous (“IV”) solution whose molecules are thousands of times smaller than red blood cells. AOC circulates in the blood collecting oxygen from the lungs and releasing the oxygen molecules where the tissue has developed ischemia, or lack of oxygen. AOC has oxygen affinity that mimics human red blood cells and is not expected to cause adverse effects. AOC is non-immunogenic, and universally compatible with all blood types. It is recognized by the Blood Brain Barrier (the “BBB”) and has low viscosity allowing it to safely deliver oxygen to the brain.
Our lead drug candidate, BXT-25, is a treatment modality intended to keep the brain tissue oxygenated and has no adverse effects. The treatment is administered through intravenous (the “IV”) injection during and after an ischemic stroke, and is being developed for stroke treatment. A stroke occurs when the blood supply to the brain is interrupted or reduced. This deprives the brain of oxygen, which can cause brain cells to die. Ischemic strokes constitute about 87% of all strokes, and are caused by a blockage of the brain’s blood supply by a blood clot. A hemorrhagic stroke is caused by a ruptured blood vessel. The oxygen is delivered to the brain immediately upon infusion (< 3 min). Once the cells become oxygenated their hypoxia condition will be reversed. The sooner oxygenated blood can be administered in these situations the better the outcomes.
The Company has constructed a prototype production line for the AOC and successfully manufactured trial batches of the compound. The material had been successfully in animal trials that show the non-toxicity of the experimental drug, along with the corresponding full recovery in Swiss Albino mice.
Many degenerative diseases such as Alzheimer, Dementia, and Parkinson’s, are affected by the lack of oxygen supplied to tissues.
Additional Areas of Interest
In the past, similar types of carbohydrate substances have been used as a fibrosis drug, dermatological drug, and a cancer drug, but are currently being reformulated to treat viral infections. We believe that we have a novel approach in treating viral infections in humans. Our drug development efforts are guided by specialists on carbohydrate chemistry and other disciplines, and we intend to supplement our efforts with input from the Scientific and the Medical Advisory Boards.
An IND with has been issued by CDSCO for an “Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of ProLectin-I Injection” for treatment of lung-fibrosis.
Company Overview
We are a clinical stage pharmaceutical company focused on the development, manufacturing and commercialization of therapeutic drugs designed to address unmet medical needs in the fields of viral infections, glycovirology, and oxygen delivery, hypoxia and degenerative diseases.
Glycovirology
We are currently working on an end-to-end solution for Covid-19 mild to severe cases and treatment for organ damage caused by the virus or by commonly used treatment methods.
| ● | ProLectin-M, a chewable polysaccharide tablet for mild to moderate cases of Covid-19. |
| ● | ProLectin-I, a polysaccharide IV treatment for more severe cases of Covid-19. |
| ● | ProLectin-F, a polysaccharide IV treatment of lung-fibrosis as a result of the use of ventilators used for treatment of Covid-19. |
| ● | ProLectin-A, a polysaccharide and Hemoglobin IV treatment of ARDS as a result of Covid-19. |
Using our issued patents and proprietary technology coupled with the scientific knowledge and expertise of Dr. David Platt, we intend to develop and manufacture ProLectin-M (oral) for treatment of mild cases and ProLectin-I (intravenous) for treatment of more severe cases of Covid-19. These treatments may also be used for the treatment of other types of viral infections, such as influenza.
A significant problem related to the Covid-19 pandemic is that an increasing number of patients are developing life- threatening complications, such as ARDS, shock (i.e., a potentially fatal drop in blood pressure), kidney failure, acute cardiac injury and secondary bacterial infections. The underlying cause for these complications is often a cytokine storm that results in a massive, systemic inflammatory response, leading to the damage of vital organs such as the lungs, heart, and kidneys, and ultimately multiple organ failure and death in many cases. For this purpose, we are developing ProLectin- A that aim to deliver oxygen to damaged organs and at the same time fight infection.
The fourth drug in this series, ProLectin-F, is being developed to treat patients developing lung fibrosis as a result of the use of ventilator in Covid-19 treatment. Increasing evidence from experimental and clinical studies suggests that mechanical ventilation, which is necessary for life support in patients with acute respiratory distress syndrome, can cause lung fibrosis, which may significantly contribute to morbidity and mortality. According to a review of medical records of 22,350 admissions showed that the cost of treating patients who were put on a ventilator was four times higher than for those treated without a ventilator and also that the death rate of pulmonary fibrosis patients who were put on a hospital ventilator was seven times higher than those treated without a ventilator, according to a review of thousands of medical records.
The Company is capitalizing on 30 years of research in Galectins and recent peer reviewed articles on Galectins and Covid-19. The founder of the Company also has an impressive body of patents in this field which gives him an advantage with respect to filing new patents based on his prior art. We will rely on a combination of patent applications, patent, trade secrets, proprietary know-how and trademarks to protect our proprietary rights. We believe that to have a competitive advantage, we must develop and maintain the proprietary aspects of our technologies. Because the drug can be taken by mouth, treatment can be started early for a potentially three-fold benefit:
| ● | inhibit patients’ progress to severe disease |
| ● | shorten the infectious phase to ease the emotional and socioeconomic toll of prolonged patient isolation, and |
| ● | rapidly silence local outbreaks |
A Proof-of-Concept trial was approved by the Internal Review Board (the “IRB”) at Mazumdar Shaw Medical Center, Narayana Health in Bangalore, India. The results of the trial are described in our three peer-reviewed articles Galectin antagonist use in mild cases of SARS-CoV-2; pilot feasibility randomised, open label, controlled trial, published in Journal of Vaccines & Vaccination on December 30, 2020, Carbohydrate ProLectin-M, a Galectin-3 Antagonist, Blocks SARS-CoV-2 Activity published in the International Journal of Health Sciences on June 30, 2022, and PLG-007 and Its Active Component Galactomannan-α Competitively Inhibit Enzymes That Hydrolyze Glucose Polymers published in the International Journal of Molecular Science on July 13, 2022.
Phase 2 Clinal Trial Results
Results from our latest Phase 2 trial on COVID-19 patients conducted at ESIS Medical College and Hospital, Sanath Nagar, Hyderabad, India, published in the peer-reviewed journal Virus: An Oral Galectin Antagonist in COVID- 19—A Phase II Randomized Controlled Trial on February 23, 2023, show positive results of its randomized, placebo- controlled Phase 2 clinical trial in thirty-four (34) patients with mild-to-moderate COVID-19. During the seven (7) days of treatment, an orally administered Galectin Antagonist in the form of a chewable tablet was administered eight (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 one hundred percent (100%) response rate by day 7 versus six percent (6%) in placebo, which was statistically significant (p-value = .001). Our analysis also revealed an 82% 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 fourteen (14) in the patient population.
On December 2, 2022, India’s Central Drugs Standard Control Organisation (CDSCO) issued an IND with permission to conduct: “A Phase 1b/2a Randomized, Blinded, placebo-controlled Study in Participants with Mild to Moderate COVID-19 to Evaluate the Safety, Efficacy, and Pharmacokinetics of Orally Administered ProLectin-M”. On March 2, 2026, the Company reported that the study showed that the highest evaluated dose of ProLectin-M (16,800 mg/day) was associated with statistically significant earlier viral clearance and faster clinical improvement by Day 5 compared with placebo, while demonstrating a favorable safety and tolerability profile. By Day 7, viral clearance was observed across all study arms, consistent with the expected natural resolution of infection in this population, indicating the treatment effect may be related to accelerating viral clearance. No serious adverse events were reported, and no treatment-related discontinuations occurred. The results provides clarity as the Company advances with its Phase 3 application. The The Phase 3 trial is projected to start in the third quarter of 2026, provided we obtain adequate funding.
On August 21, 2023, the Company’s IND #153742 under the title “PROTECT: PROlectin-m, a nucleocapsid TErminal galeCTin antagonist for COVID-19 (PROTECT), a Randomized, Double-blinded Clinical Trial to Evaluate the Efficacy and Safety in Non-Hospitalized Adult Participants with COVID-19” was approved by the FDA. The trial is expected to start in the third quarter of 2026, provided we obtain adequate funding.
On January 27, 2023, an additional IND with the CDSCO was issued for ProLectin-I for an “IV treatment of SARS- CoV-2 in hospitalized patients with moderate Covid-19 infections and for Long Covid”, and for ProLectin-F for “treatment of lung-fibrosis as a result of use of ventilator”.
Hypoxia and Degenerative Diseases
Currently, the Bioxytran’s lead pharmaceutical drug candidate, BXT-25 is planned to be an Acellular Oxygen Carrier (“AOC”) consisting of camel hemoglobin stabilized with a co-polymer. This modified hemoglobin will be designed to be an injectable intravenous drug and we plan to begin pre-clinical studies and apply to the Food and Drug Administration (FDA) for approval to use BXT-25 to prevent necrosis by carrying oxygen to human tissue with blood flow to the brain. If we successfully complete Phase I testing with the FDA, we plan to explore the use of additional drug candidates using chemical structures that are a sub-class of BXT-25 and share the same physical properties to treat wound healing due to hypoxia, cardiovascular ischemia, anemia, cancer conditions and trauma, subject to FDA approval.
BXT-25 is a novel unproven technology. Although we have not conducted research applying our co-polymer technology and related chemistry to the treatment of hypoxic conditions, we know from Dr. Platt’s prior research that our technology enables the creation of molecules that are thousands of times smaller than human red blood cells and we believe that our proprietary technology will enable these molecules to carry oxygen for delivery to tissue through the bloodstream. We also believe that the small size of these molecules will more effectively enable their delivery to hypoxic tissues which red blood cells cannot reach under the clinical conditions we intend to address. We may be unsuccessful in developing these technologies into drugs which the FDA ultimately will approve.
Stroke
Stroke, also known as cerebrovascular accident (CVA), or brain attack, occurs when poor blood-flow to the brain results in necrosis and cell death. Strokes can be classified into two major categories: ischemic and hemorrhagic. Ischemic strokes are caused by interruption of the blood supply to the brain; hemorrhagic strokes result from the rupture of a blood vessel or an abnormal vascular structure. According to the Center for Disease Control, approximately 87% of all strokes are ischemic strokes. An ischemic stroke may be thrombotic, which occurs when diseased or damaged cerebral arteries become blocked by the formation of a blood clot within the brain, or embolic, which occurs when a clot formed originally somewhere in the body outside the brain - typically in the heart - travels in a cerebral artery. Whether thrombotic or embolic, an ischemic stroke restricts the flow of blood to the brain and results in near-immediate physical and neurological deficits.
According to the Center for Disease Control, there are about 795,000 new or recurrent cases of stroke in the United States each year, of which 610,000 are new cases and 185,000 recurrent cases. One hundred thirty thousand (130,000) Americans are killed by stroke each year, or one every four minutes. Stroke is a leading cause of serious long-term disability and costs the United States an estimated $34 Billion each year, according to the Center for Disease Control, a figure which includes the cost of health care services, medications to treat the stroke, and missed days of work.
Hemoglobin and Complex Co-Polymer Science
Oxygen therapeutics describe generally a class of agents that will be administered intravenously to enhance the oxygen delivery capability of blood. These oxygen transporting agents may be perfluorocarbon (PFC) emulsions or modified hemoglobin solutions. Our technology involves the development of hemoglobin-based oxygen carriers. To produce BXT-25, we will take red blood cells (RBCs) from camel sources, isolate hemoglobin from the RBCs and, by applying our proprietary co-polymer chemistry, stabilize and modify the hemoglobin. Our novel, complex co-polymer molecules can be produced at specific molecular weights and with other pharmaceutical properties for various hypoxic diseases; and in the production of BXT-25.
The BXT-25 co-polymer hemoglobin molecule will be designed to be 5,000 times smaller than an RBC, which we believe will enable that small molecule to reach hypoxic tissue more effectively than RBCs. BXT-25 will be designed to be administered as an injectable IV drug that will circulate in the blood collecting oxygen from the lungs and releasing the oxygen molecules where tissue has developed ischemia, or lack of oxygen. BXT-25 will be designed to have oxygen affinity that mimics RBCs, minimize adverse effects, and be compatible with all blood types. BXT will be designed to have a shelf life of two years at room temperature.
With regard to compatibility with all blood types, we believe that the differences between a BXT-25 molecule and a red blood cell will not be limited to differences in size. Surfaces of red blood cells include different antigens which determine the blood type as A, B, AB or O. We believe that BXT-25 will be found to be compatible with all blood types because it is a single, modified hemoglobin molecule stabilized with a co-polymer which, unlike a red blood cell, has neither antigens nor a Rh factor.
Certain regulatory issues relating to our use of camel hemoglobin as a raw material
Our products include a commercially available raw material, camel hemoglobin, that has been purified, chemically modified and cross-linked for stability. It is sourced from controlled herds of camels raised for various applications. Those herds are subject to and meet the requirements of a herd management program that assures the origin, health, feed and quality of the camels used as a raw material source. Our suppliers will contract to maintain traceable records on animal origin, health, feed and care as part of our effort to assure the use of known, healthy animals in compliance with applicable laws and regulations.
Camel whole blood will be collected in individual pre-sanitized containers. The containers will be shipped to a separation facility. Prior to the collection of blood, the animals undergo live inspection. We have validated and tested the processes described below for removal of potential pathogens in our raw material. Potential pathogens include bacteria, viruses such as those leading to hepatitis and AIDS. The validation of a process means that it has been tested and documented and that it performs adequately. Health and regulatory authorities have given guidance directed at three factors to control these diseases: source of animals, the nature of tissue used and manufacturing process. We will comply with, and believe we will exceed, all current guidelines regarding such risks for human pharmaceutical products.
There will be four major steps in the manufacture of BXT-25: (1) hemoglobin separation; (2) hemoglobin purification; (3) polymerization/size selection and (4) synthesizing with our co-polymer. More specifically, camel blood will be collected in an aseptic fashion and processed to first remove plasma and then to remove at high concentration the hemoglobin protein from red blood cells. The hemoglobin will be purified of other red cell proteins by anion exchange chromatography. The purified hemoglobin will be stabilized by the addition of a cross-linking agent to form hemoglobin polymers. There is an additional sizing step to remove the higher hemoglobin molecules. The final step, co-polymer synthesis, will take place on the stabilized hemoglobin. The combination polymers will be filled with a solution suitable for infusion. The product will be run through sterilizing filters into sterile product bags.
Strategic Objectives
It is our intention to develop the drug to the point whereby the Company would be in a position to license the drug to large pharmaceuticals capable of conducting clinical trials and managing the distribution of the product. The Company does not plan to create a sales and marketing staff to commercialize the pharmaceutical products it produces. The Company would be dependent on third parties such as licensees, collaborators, joint venture partners or independent distributors to market and sell those products.
The FDC Act and other federal and state statutes and regulations govern the testing, manufacture, safety, effectiveness, labeling, storage, record keeping, approval, advertising and promotion of our products. As a result of these laws and regulations, product development and product approval processes are very expensive and time-consuming. Our goal is to advance our leading drug candidate, BXT-25, and our Subsidiary’s leading drug candidate, ProLectin-Rx, through regulatory submissions for Investigational New Drug (IND) status in the United States, is subject to expensive and time-consuming approval processes.
Management
Our management team and advisors include, most notably, our CEO and Chairman David Platt, Ph.D., who has played a leading role in the development of complex co-polymer therapeutics for a variety of applications to address a variety of unmet medical needs. Our CFO, Ola Soderquist, CPA, CMA, is a seasoned financial officer with more than 30 years of senior international entrepreneurial management experience within many industries, both in public and private companies.
Dr. Platt and Mr. Soderquist are our only employees and each of them is committed on a full-time basis. David Platt and Ola Soderquist currently have a monthly salary of $35,000, along with a 25% 401(k) Safe Harbor coverage up to the federal limit, currently $70,000 per year plus potential catchup, currently $11,250, as well as reimbursement of a gold-level healthcare plan.
Our Executive Officers and Directors may also receive stock or stock options at the discretion of our Board of Directors according to approved the 2021 Stock Plan, or any subsequent Stock Plan.
Business Development
We are a clinical stage pharmaceutical company focused on the development, manufacturing and commercialization of therapeutic drugs designed to address unmet medical needs in the fields of viral infections, glycovirology, and oxygen delivery, hypoxia and degenerative diseases.
Glycovirology
We are currently working on an end-to-end solution for Covid-19 mild to severe cases and treatment for organ damage caused by the virus or by commonly used treatment methods.
| ● | ProLectin-M, a chewable polysaccharide tablet for mild to moderate cases of Covid-19. |
| ● | ProLectin-I, a polysaccharide IV treatment for more severe cases of Covid-19. |
| ● | ProLectin-F, a polysaccharide IV treatment of lung-fibrosis as a result of the use of ventilators used for treatment of Covid-19. |
| ● | ProLectin-A, a polysaccharide and Hemoglobin IV treatment of ARDS as a result of Covid-19. |
Using our issued patents and proprietary technology coupled with the scientific knowledge and expertise of Dr. David Platt, we intend to develop and manufacture ProLectin-M (oral) for treatment of mild cases and ProLectin-I (intravenous) for treatment of more severe cases of Covid-19. These treatments may also be used for the treatment of other types of viral infections, such as influenza.
A significant problem related to the Covid-19 pandemic is that an increasing number of patients are developing life- threatening complications, such as ARDS, shock (i.e., a potentially fatal drop in blood pressure), kidney failure, acute cardiac injury and secondary bacterial infections. The underlying cause for these complications is often a cytokine storm that results in a massive, systemic inflammatory response, leading to the damage of vital organs such as the lungs, heart, and kidneys, and ultimately multiple organ failure and death in many cases. For this purpose, we are developing ProLectin- A that aim to deliver oxygen to damaged organs and at the same time fight infection.
The fourth drug in this series, ProLectin-F, is being developed to treat patients developing lung fibrosis as a result of the use of ventilator in Covid-19 treatment. Increasing evidence from experimental and clinical studies suggests that mechanical ventilation, which is necessary for life support in patients with acute respiratory distress syndrome, can cause lung fibrosis, which may significantly contribute to morbidity and mortality. According to a review of medical records of 22,350 admissions showed that the cost of treating patients who were put on a ventilator was four times higher than for those treated without a ventilator and also that the death rate of pulmonary fibrosis patients who were put on a hospital ventilator was seven times higher than those treated without a ventilator, according to a review of thousands of medical records.
The Company is capitalizing on 30 years of research in Galectins and recent peer reviewed articles on Galectins and Covid-19. The founder of the Company also has an impressive body of patents in this field which gives him an advantage with respect to filing new patents based on his prior art. We will rely on a combination of patent applications, patent, trade secrets, proprietary know-how and trademarks to protect our proprietary rights. We believe that to have a competitive advantage, we must develop and maintain the proprietary aspects of our technologies. Because the drug can be taken by mouth, treatment can be started early for a potentially three-fold benefit:
| ● | inhibit patients’ progress to severe disease |
| ● | shorten the infectious phase to ease the emotional and socioeconomic toll of prolonged patient isolation, and |
| ● | rapidly silence local outbreaks |
A Proof-of-Concept trial was approved by the IRB at Mazumdar Shaw Medical Center, Narayana Health in Bangalore, India. The results of the trial are described in our three peer-reviewed articles Galectin antagonist use in mild cases of SARS-CoV-2; pilot feasibility randomised, open label, controlled trial, published in Journal of Vaccines & Vaccination on December 30, 2020, Carbohydrate ProLectin-M, a Galectin-3 Antagonist, Blocks SARS-CoV-2 Activity published in the International Journal of Health Sciences on June 30, 2022, and PLG-007 and Its Active Component Galactomannan-α Competitively Inhibit Enzymes That Hydrolyze Glucose Polymers published in the International Journal of Molecular Science on July 13, 2022.
Phase 2 Clinal Trial Results
Results from our latest Phase 2 trial on COVID-19 patients conducted at ESIS Medical College and Hospital, Sanath Nagar, Hyderabad, India, published in the peer-reviewed journal Virus: An Oral Galectin Antagonist in COVID- 19—A Phase II Randomized Controlled Trial on February 23, 2023, show positive results of its randomized, placebo- controlled Phase 2 clinical trial in thirty-four (34) patients with mild-to-moderate COVID-19. During the seven (7) days of treatment, an orally administered Galectin Antagonist in the form of a chewable tablet was administered eight (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 one hundred percent (100%) response rate by day 7 versus six percent (6%) in placebo, which was statistically significant (p-value = .001). Our analysis also revealed an 82% 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 fourteen (14) in the patient population.
On December 2, 2022, India’s Central Drugs Standard Control Organisation (CDSCO) issued an IND with permission to conduct: “A Phase 1b/2a Randomized, Blinded, placebo-controlled Study in Participants with Mild to Moderate COVID-19 to Evaluate the Safety, Efficacy, and Pharmacokinetics of Orally Administered ProLectin-M”. On March 2, 2026, the Company reported that the study showed that the highest evaluated dose of ProLectin-M (16,800 mg/day) was associated with statistically significant earlier viral clearance and faster clinical improvement by Day 5 compared with placebo, while demonstrating a favorable safety and tolerability profile. By Day 7, viral clearance was observed across all study arms, consistent with the expected natural resolution of infection in this population, indicating the treatment effect may be related to accelerating viral clearance. No serious adverse events were reported, and no treatment-related discontinuations occurred. The results provides clarity as the Company advances with its Phase 3 application. The The Phase 3 trial is projected to start in the third quarter of 2026, provided we obtain adequate funding.
On August 21, 2023, the Company’s IND #153742 under the title “PROTECT: PPRlectin-m, a nucleocapsid TErminal galeCTin antagonist for COVID-19 (PROTECT), a Randomized, Double-blinded Clinical Trial to Evaluate the Efficacy and Safety in Non-Hospitalized Adult Participants with COVID-19” was approved by the FDA. The trial is expected to start in the third quarter of 2026, provided we obtain adequate funding.
On January 27, 2023, an additional IND with the CDSCO was issued for ProLectin-I for an “IV treatment of SARS- CoV-2 in hospitalized patients with moderate Covid-19 infections and for Long Covid”, and for ProLectin-F for “treatment of lung-fibrosis as a result of use of ventilator”.
Hypoxia and Degenerative Diseases
Currently, Bioxytran’s lead pharmaceutical drug candidate, BXT-25 is planned to be an Acellular Oxygen Carrier (“AOC”) consisting of camel hemoglobin stabilized with a co-polymer. This modified hemoglobin will be designed to be an injectable intravenous drug and we plan to begin pre-clinical studies and apply to the Food and Drug Administration (FDA) for approval to use BXT-25 to prevent necrosis by carrying oxygen to human tissue with blood flow to the brain. If we successfully complete Phase I testing with the FDA, we plan to explore the use of additional drug candidates using chemical structures that are a sub-class of BXT-25 and share the same physical properties to treat wound healing due to hypoxia, cardiovascular ischemia, anemia, cancer conditions and trauma, subject to FDA approval.
BXT-25 is a novel unproven technology. Although we have not conducted research applying our co-polymer technology and related chemistry to the treatment of hypoxic conditions, we know from Dr. Platt’s prior research that our technology enables the creation of molecules that are thousands of times smaller than human red blood cells and we believe that our proprietary technology will enable these molecules to carry oxygen for delivery to tissue through the bloodstream. We also believe that the small size of these molecules will more effectively enable their delivery to hypoxic tissues which red blood cells cannot reach under the clinical conditions we intend to address. We may be unsuccessful in developing these technologies into drugs which the FDA ultimately will approve.
Stroke
Stroke, also known as cerebrovascular accident (CVA), or brain attack, occurs when poor blood-flow to the brain results in necrosis and cell death. Strokes can be classified into two major categories: ischemic and hemorrhagic. Ischemic strokes are caused by interruption of the blood supply to the brain; hemorrhagic strokes result from the rupture of a blood vessel or an abnormal vascular structure. According to the Center for Disease Control, approximately 87% of all strokes are ischemic strokes. An ischemic stroke may be thrombotic, which occurs when diseased or damaged cerebral arteries become blocked by the formation of a blood clot within the brain, or embolic, which occurs when a clot formed originally somewhere in the body outside the brain - typically in the heart - travels in a cerebral artery. Whether thrombotic or embolic, an ischemic stroke restricts the flow of blood to the brain and results in near-immediate physical and neurological deficits.
According to the Center for Disease Control, there are about 795,000 new or recurrent cases of stroke in the United States each year, of which 610,000 are new cases and 185,000 recurrent cases. One hundred thirty thousand (130,000) Americans are killed by stroke each year, or one every four minutes. Stroke is a leading cause of serious long-term disability and costs the United States an estimated $34 Billion each year, according to the Center for Disease Control, a figure which includes the cost of health care services, medications to treat the stroke, and missed days of work.
Hemoglobin and Complex Co-Polymer Science
Oxygen therapeutics describe generally a class of agents that will be administered intravenously to enhance the oxygen delivery capability of blood. These oxygen transporting agents may be perfluorocarbon (PFC) emulsions or modified hemoglobin solutions. Our technology involves the development of hemoglobin-based oxygen carriers. To produce BXT-25, we will take red blood cells (RBCs) from camel sources, isolate hemoglobin from the RBCs and, by applying our proprietary co-polymer chemistry, stabilize and modify the hemoglobin. Our novel, complex co-polymer molecules can be produced at specific molecular weights and with other pharmaceutical properties for various hypoxic diseases; and in the production of BXT-25.
The BXT-25 co-polymer hemoglobin molecule will be designed to be 5,000 times smaller than an RBC, which we believe will enable that small molecule to reach hypoxic tissue more effectively than RBCs. BXT-25 will be designed to be administered as an injectable IV drug that will circulate in the blood collecting oxygen from the lungs and releasing the oxygen molecules where tissue has developed ischemia, or lack of oxygen. BXT-25 will be designed to have oxygen affinity that mimics RBCs, minimize adverse effects, and be compatible with all blood types. BXT will be designed to have a shelf life of two years at room temperature.
With regard to compatibility with all blood types, we believe that the differences between a BXT-25 molecule and a red blood cell will not be limited to differences in size. Surfaces of red blood cells include different antigens which determine the blood type as A, B, AB or O. We believe that BXT-25 will be found to be compatible with all blood types because it is a single, modified hemoglobin molecule stabilized with a co-polymer which, unlike a red blood cell, has neither antigens nor a Rh factor.
Certain regulatory issues relating to our use of camel hemoglobin as a raw material
Our products include a commercially available raw material, camel hemoglobin, that has been purified, chemically modified and cross-linked for stability. It is sourced from controlled herds of camels raised for various applications. Those herds are subject to and meet the requirements of a herd management program that assures the origin, health, feed and quality of the camels used as a raw material source. Our suppliers will contract to maintain traceable records on animal origin, health, feed and care as part of our effort to assure the use of known, healthy animals in compliance with applicable laws and regulations.
Camel whole blood will be collected in individual pre-sanitized containers. The containers will be shipped to a separation facility. Prior to the collection of blood, the animals undergo live inspection. We have validated and tested the processes described below for removal of potential pathogens in our raw material. Potential pathogens include bacteria, viruses such as those leading to hepatitis and AIDS. The validation of a process means that it has been tested and documented and that it performs adequately. Health and regulatory authorities have given guidance directed at three factors to control these diseases: source of animals, the nature of tissue used and manufacturing process. We will comply with, and believe we will exceed, all current guidelines regarding such risks for human pharmaceutical products.
There will be four major steps in the manufacture of BXT-25: (1) hemoglobin separation; (2) hemoglobin purification; (3) polymerization/size selection and (4) synthesizing with our co-polymer. More specifically, camel blood will be collected in an aseptic fashion and processed to first remove plasma and then to remove at high concentration the hemoglobin protein from red blood cells. The hemoglobin will be purified of other red cell proteins by anion exchange chromatography. The purified hemoglobin will be stabilized by the addition of a cross-linking agent to form hemoglobin polymers. There is an additional sizing step to remove the higher hemoglobin molecules. The final step, co-polymer synthesis, will take place on the stabilized hemoglobin. The combination polymers will be filled with a solution suitable for infusion. The product will be run through sterilizing filters into sterile product bags.
FDA Approval Process
In the United States, pharmaceutical products, including biologics like BXT-25, are subject to extensive regulation by the FDA. The FDC Act and other federal and state statutes and regulations, govern, among other things, the research, development, testing, manufacture, storage, recordkeeping, approval, labeling, promotion and marketing, distribution, post-approval monitoring and reporting, sampling, and import and export of pharmaceutical products. Failure to comply with applicable U.S. requirements may subject a company to a variety of administrative or judicial sanctions, such as FDA refusal to approve pending new drug applications, or NDAs, warning letters, product recalls, product seizures, total or partial suspension of production or distribution, injunctions, fines, civil penalties, and criminal prosecution.
Pharmaceutical product development in the United States typically involves preclinical laboratory and animal tests, the submission to the FDA/EMA of an IND application, which must become effective before clinical testing may commence, and adequate and well-controlled clinical trials to establish the safety and effectiveness of the drug or biologic for each indication for which FDA/EMA approval is sought. Satisfaction of FDA/EMA pre-market approval requirements typically take many years (typically between 5-7 years post an IND submission) and the actual time required may vary substantially based upon the type, complexity and novelty of the product or disease.
Preclinical tests include laboratory evaluation as well as animal trials to assess the characteristics and potential pharmacology and toxicity of the product. The conduct of the preclinical tests must comply with federal regulations and requirements including good laboratory practices. The results of preclinical testing are submitted to the FDA as part of an IND along with other information, including information about product chemistry, manufacturing and controls, and a proposed clinical trial protocol. Long term preclinical tests, such as animal tests of reproductive toxicity and carcinogenicity, may continue after the IND is submitted.
A 30-day waiting period after the submission of each IND is required prior to the commencement of clinical testing in humans. If the FDA has not objected to the IND within this 30-day period, the clinical trial proposed in the IND may begin.
Clinical trials involve the administration of the investigational drug to healthy volunteers or patients under the supervision of a qualified investigator. Clinical trials must be conducted in compliance with federal regulations and good clinical practices, or GCP, as well as under protocols detailing the objectives of the trial, the parameters to be used in monitoring safety and the effectiveness criteria to be evaluated. Each protocol involving testing on U.S. patients and subsequent protocol amendments must be submitted to the FDA as part of the IND.
The FDA may order the temporary or permanent discontinuation of a clinical trial at any time or impose other sanctions if it believes that the clinical trial is not being conducted in accordance with FDA requirements or presents an unacceptable risk to the clinical trial patients. The clinical trial protocol and informed consent information for patients in clinical trials must also be submitted to an institutional review board, or IRB, for approval. An IRB may also require the clinical trial at the site to be halted, either temporarily or permanently, for failure to comply with the IRB’s requirements, or may impose other conditions.
Clinical trials to support New Drug Applications (NDAs) are typically conducted in three sequential Phases, but the Phases may overlap. In Phase 1, the initial introduction of the investigational drug candidate into healthy human subjects or patients, the investigational drug is tested to assess metabolism, pharmacokinetics, pharmacological actions, side effects associated with increasing doses and, if possible, early evidence on effectiveness. Phase 2 usually involves trials in a limited patient population, to determine the effectiveness of the investigational drug for a particular indication or indications, dosage tolerance and optimum dosage, and identify common adverse effects and safety risks. In the case of product candidates for severe or life-threatening diseases such as pneumonia, the initial human testing is often conducted in patients rather than in healthy volunteers.
If an investigational drug demonstrates evidence of effectiveness and an acceptable safety profile in Phase 2 evaluations, Phase 3 clinical trials are undertaken to obtain additional information about clinical efficacy and safety in a larger number of patients, typically at geographically dispersed clinical trial sites, to permit the FDA to evaluate the overall benefit-risk relationship of the investigational drug and to provide adequate information for its labeling.
After completion of the required clinical testing, an NDA, is prepared and submitted to the FDA. FDA approval of the marketing application is required before marketing of the product may begin in the United States. The marketing application must include the results of all preclinical, clinical and other testing and a compilation of data relating to the product’s pharmacology, chemistry, manufacture, and controls.
The FDA has 60 days from its receipt of an NDA to determine whether the application will be accepted for filing based on the agency’s threshold determination that it is sufficiently complete to permit substantive review. Once the submission is accepted for filing, the FDA begins an in-depth review. The FDA has agreed to certain performance goals in the review of marketing applications. Most such applications for non-priority drug products are reviewed within ten months. The review process may be extended by the FDA for three additional months to consider new information submitted during the review or clarification regarding information already provided in the submission. The FDA may also refer applications for novel drug products or drug products that present difficult questions of safety or efficacy to an advisory committee, typically a panel that includes clinicians and other experts, for review, evaluation and a recommendation as to whether the application should be approved. The FDA is not bound by the recommendation of an advisory committee, but it generally follows such recommendations. Before approving a marketing application, the FDA will typically inspect one or more clinical sites to assure compliance with GCP.
Additionally, the FDA will inspect the facility or the facilities at which the drug product is manufactured. The FDA will not approve the NDA unless compliance with cGMP is satisfactory and the marketing application contains data that provide substantial evidence that the product is safe and effective in the indication studied. Manufacturers of biologics also must comply with FDA’s general biological product standards.
After the FDA evaluates the NDA and the manufacturing facilities, it issues an approval letter or a complete response letter. A complete response letter outlines the deficiencies in the submission and may require substantial additional testing or information in order for the FDA to reconsider the application. If and when those deficiencies have been addressed in a resubmission of the marketing application, the FDA will re-initiate review. If the FDA is satisfied that the deficiencies have been addressed, the agency will issue an approval letter. The FDA has committed to reviewing such resubmissions in two or six months depending on the type of information included. It is not unusual for the FDA to issue a complete response letter because it believes that the drug product is not safe enough or effective enough or because it does not believe that the data submitted are reliable or conclusive.
An approval letter authorizes commercial marketing of the drug product with specific prescribing information for specific indications. As a condition of approval of the marketing application, the FDA may require substantial post-approval testing and surveillance to monitor the drug product’s safety or efficacy and may impose other conditions, including labeling restrictions, which can materially affect the product’s potential market and profitability. Once granted, product approvals may be withdrawn if compliance with regulatory standards is not maintained or problems are identified following initial marketing.
Once an NDA is approved, a product will be subject to certain post-approval requirements. For instance, the FDA closely regulates the post-approval marketing and promotion of therapeutic products, including standards and regulations for direct-to-consumer advertising, off-label promotion, industry-sponsored scientific and educational activities and promotional activities involving the internet.
European Directorate for the Quality of Medicines Certification (EDQM)
Certification from the European Directorate for the Quality of Medicines (EDQM) is required for all new and approved human and veterinary medicinal products that are manufactured from materials taken from cattle and marketed in the European Union. As part of the certification process, we will be required to provide technical information on the manufacturing process, the origin of the raw material and type of tissue used, the cattle traceability, beginning at their country of birth, and auditing, and a risk analysis from an independent expert.
We intend to establish and implement clinical development programs that add value to our business in the shortest period of time possible and to seek strategic partners when a program becomes advanced and requires additional resources. We intend to continue focusing our expertise and resources to develop novel formulations, and to leverage development partnerships to apply our complex co-polymer chemistry designs in other medical indications. We may seek to enter into licensing, co-marketing, or co-development agreements across different geographic regions, in order to avail ourselves of the marketing expertise of one or more seasoned marketing and/or pharmaceutical companies. We plan to further develop new and proprietary drug candidates by using novel development pathways specific to each drug candidate.
A core part of our strategy relies upon creating safe and efficacious drug formulations that can be administered as standalone therapies or in combination with existing medications. We believe we utilize a novel approach that is expected to create drug formulations that can be combined with existing therapies and potentially deliver valuable products in areas of high unmet medical needs. We will assemble a scientific advisory board consisting of scientists with both academic and corporate research and development experience that will provide leadership and counsel in the scientific, technological and regulatory aspects of our current and future projects. In addition, we will assemble a medical advisory board consisting of leading physicians and key opinion leaders who have participated in relevant clinical studies and who will guide us through ongoing clinical trial programs. Our scientific and medical advisory boards consist of some of leading scientists, medical doctors and professionals in the co-polymer and ischemic brain injury field.
We believe that our drug development leadership team provides us with a significant competitive advantage in designing highly efficient clinical programs to deliver valuable products in areas of high unmet medical needs.
Project Costs ProLectin-Rx
Pharmalectin is a single purpose entity aiming to develop pharmaceutical cures for Covid-19 (collectively referred to as “ProLectin-Rx”) and bring the drugs through FDA acceptance, and thereafter, license out the product(s). The total cost of the project is estimated to cost $30 million of which approximately $5 million has been invested so far.
As of December 31, 2025, Good Manufacturing Practice (GMP), pre-clinical and two clinical Phase I/II study have been completed for the initial drug, ProLectin-M, which is an oral formulation against mild to moderate symptoms of the disease and GMP has been completed for ProLectin-I, and -F.
On December 2, 2022, India’s Central Drugs Standard Control Organisation (CDSCO) issued an IND with permission to conduct: “A Phase 1b/2a Randomized, Blinded, placebo-controlled Study in Participants with Mild to Moderate COVID-19 to Evaluate the Safety, Efficacy, and Pharmacokinetics of Orally Administered ProLectin-M”. On March 2, 2026, the Company reported that the study showed that the highest evaluated dose of ProLectin-M (16,800 mg/day) was associated with statistically significant earlier viral clearance and faster clinical improvement by Day 5 compared with placebo, while demonstrating a favorable safety and tolerability profile. By Day 7, viral clearance was observed across all study arms, consistent with the expected natural resolution of infection in this population, indicating the treatment effect may be related to accelerating viral clearance. No serious adverse events were reported, and no treatment-related discontinuations occurred. The results provides clarity as the Company advances with its Phase 3 application. The The Phase 3 trial is projected to start in the third quarter of 2026, provided we obtain adequate funding.
On January 27, 2023, an additional IND with the CDSCO was issued for an IV treatment of SARS-CoV-2 in moderate (Hospitalized patients) Covid-19 infections (ProLectin-I), Long Covid, and of treatment of lung-fibrosis as a result of use of ventilator in treatment of Covid-19 (ProLectin-F), respectively.
On August 21, 2023, the Company’s IND #153742 under the title “PROTECT: ProLectin-M, a nucleocapsid TErminal GaleCTin antagonist for COVID-19 (PROTECT), a Randomized, Double-blinded Clinical Trial to Evaluate the Efficacy and Safety in Non-Hospitalized Adult Participants with COVID-19” was approved by the FDA, the trial is expected to start in the third quarter of 2026, provided we obtain adequate funding.
In addition to the approximately $5.0 million currently invested in the project, we believe we will be required to spend an additional $0.1 million for submission of Investigational New Drug application (IND) protocol, approximately $1.0 million in a Phase I safety study, 200,000 for additional in-vitro studies (incl HIV and Ebola), $0.1 for the development of a PK method, and 2,000,000 for a Phase 2 (dosage and pharmacokinetics) and an additional 10,000,000 for a Phase III clinical trials.
Further, we will be required to spend an additional $5.3 million in order to submit an IND with the FDA for ProLectin-M, -I and, as well as a proof of concept for ProLectin-F. An additional spending in the range of $8 to $10 million will be required in order to complete the Phase IIb/III testing with the FDA and EMA of the ProLectin-I and -F.
Approximately 15%, or $3.3 million, will need to be added in overhead, and $1 million for General and Administrative and general working capital purposes.
| Estimated Cost | |
|---|---|
| ProLectin-M | |
| Clinical Trials: | |
| IND Protocol (IND #153742) | $100,000 |
| Phase 1 – safety | 1,000,000 |
| In-vitro trials 10-15 viruses | 200,000 |
| PK Method | 100,000 |
| Phase 2 – dose optimization and PK | 2,000,000 |
| Phase 3 – efficacy | 10,000,000 |
| Total Estimated Cost | $13,400,000 |
| ProLectin-I and -F | |
| Clinical Trials: | |
| IND Protocol | $200,000 |
| Phase 1 – safety | 1,000,000 |
| PK Method | 100,000 |
| Phase 2 – dose optimization and PK | 4,000,000 |
| Total Estimated Cost | $5,300,000 |
| Overhead (15%) | 3,300,000 |
| GNA | 1,000,000 |
| Total Project Cost ProLectin-Rx | $23,000,000 |
Project Costs Universal Oxygen Carrier (“UOC”)
ProLectin-A
In order to develop ProLectin-A, the Company will need an additional $12 million, approximately $4.0 million of proceeds will be used for preparation for scale up and Good Manufacturing Practices (“GMP”) facility, $2.0 million for the adaptation of the MDX-Viewer, approximately $1.0 million will be used for toxicity testing in animals and for Investigational New Drug application (IND) protocol, approximately $5.0 million for Phase I (safety) and Phase II (proof of concept) clinical trials.
We expect that obtaining a CE from the European Directorate for the Quality of Medicines will require an additional $3.0 million in funds.
BXT-25
In order to start the development BXT-25, the Company will need an additional $5.2 million. Approximately $0.2 million to prepare and submit the IND protocol. Approximately $5.0 million for Phase I (safety) and Phase II (proof of concept) clinical trials.
We expect that obtaining a CE from the European Directorate for the Quality of Medicines will require an additional $0.5 million in funds. G&A is expected to be $3.0 million.
Approximately 15%, or $2.9 million will need to be added in overhead, and $1 million for General and Administrative and general working capital purposes.
| Estimated Cost | |
|---|---|
| ProLectin-A | |
| Clinical Trials: | |
| Animal toxicity | $800,000 |
| GMP Facility | 4,000,000 |
| MDX-Viewer | 2,000,000 |
| IND Protocol | 200,000 |
| Phase 1 – safety | 1,000,000 |
| Phase 2 – dose optimization and PK | 4,000,000 |
| Total Estimated Cost | $12,000,000 |
| Clinical Trials: | |
| IND Submission | $200,000 |
| Phase 1 – safety | 1,000,000 |
| Phase 2 – dose optimization and PK | 4,000,000 |
| Total Estimated Cost | $5,200,000 |
| Overhead (15%) | 2,850,000 |
| GNA | 950,000 |
| Total Project Cost AOC | $21,000,000 |
In aggregate, we believe we will require an additional $30-35 million in order to complete the II/a trials with the FDA for ProLectin-A and BXT-25 and the Phase II/b/III trials for ProLectin-I and -F. There are no guarantees the Company will be able to obtain additional capital funder, whether through debt and/or equity financing, or will be able to raise funds on terms acceptable to the Company.
Market Opportunity
Glycovirology
Pharmalectin, a subsidiary, is focusing on the development, manufacturing and commercialization of therapeutic drugs designed to address viral diseases in humans. The Company has developed a novel method designed to reduce the viral load and modulate the immune system using a galectin Antagonist.
Currently, the Subsidiary’s lead drug candidate is a glycovirology platform technology named ProLectin, a complex galectin antagonist that binds to, and blocks the activity of galectin-3, a type of galectin. During viral infections galectins are upregulated and downregulated based on the type of virus.
To our knowledge, Pharmalectin, Inc. is the only company planning to develop a viable end-to-end solution for Covid-19. We are also the only company, to our knowledge, attempting to use a Galectin Antagonist to combat the virus, SARS-CoV-2. The technology is built on the life-time work by the founder of the Company, Dr. Platt, who discovered, and named, the Human Galectin-3 protein coded by a single gene, LGALS3, located on chromosome 14, and published in his groundbreaking article, Structure-Function Relationship of a Recombinant Human Galactoside-Binding Protein, Biochemistry 1993. Galectin Antagonists block the binding of galectins to carbohydrate structures, present in numerous diseases, reducing their capability to replicate. Over the years, Dr. Platt has used this knowledge to create a significant number of sustainable therapeutic solutions.
Using our issued patents and proprietary technology, we intend to develop and manufacture ProLectin-RX and similar drugs for applications including treatment of virological conditions. Our patent position consists of two patents of methods for treating SARS-CoV-2 by administering an effective amount of complex polysaccharides to subjects issued in 2022 by the International Bureau of the Patent Cooperation Treaty (PCT) expiring in February 2041 (Polysaccharides for IV Administration that Treat Sars-Cov-2 Infections - WO2022099061A1) and (Polysaccharides for Use in Treating Sars- Cov-2 Infections - WO2022099052A1), as well as a patent expiring in 2043 (Lectin-Binding Carbohydrates for Treating Viral Infections - WO2023178228A1). These patents were assigned to us outright by Dr. Platt. Dr Platt did not receive any compensation from the Company in consideration of his assignments.
Further, Pharmalectin has received an international trademark for ProLectin (WO0000001646681).
The Company is capitalizing on 30 years of research in Galectins and recent peer reviewed articles on Galectins and Covid-19. Dr. Platt also has an impressive body of patents in this field which gives him an advantage with respect to filing new patents based on his prior art. We will rely on a combination of patent applications, patent, trade secrets, proprietary know-how and trademarks to protect our proprietary rights. We believe that to have a competitive advantage, we must develop and maintain the proprietary aspects of our technologies. Because the drug can be taken by mouth, treatment can be started early for a potentially three-fold benefit:
| ● | inhibit patients’ progress to severe disease |
|---|---|
| ● | shorten the infectious phase to ease the emotional and socioeconomic toll of prolonged patient isolation, and |
| ● | rapidly silence local outbreaks |
Hypoxia and Degenerative Diseases
Using our proprietary technology, we will develop and manufacture BXT-25 and similar drugs for applications including treatment of stroke conditions. Bioxytran has an exclusive license for an FDA approved technology monitoring NADH (MDX Viewer), the control marker in the body’s conversion of Oxygen to Energy, or the energy generating chain. The technology provides a clinical end-point for measuring oxygen supply to the brain in real-time. MDX Viewer, developed by MDX LifeSciences, Inc., provides us with the potential to develop new molecules that could potentially address unmet medical needs in disease indications resulting from hypoxia. MDX LifeSciences has licensed a patent (Tissue Metabolic Score for Patient Monitoring - US20210153816A1) to Bioxytran for clinical monitoring of oxygen delivery through oxygen carriers. MDX Lifesciences is an Affiliate of the Company.
On April 19, 2023, the Company announced that its long awaited Acelluar Oxygen Carrier (“AOC”) BXT-25 had been successfully tested in animals. The initial results are very encouraging because they show the non-toxicity of the experimental drug, along with the corresponding full recovery in Swiss Albino mice, in an experiment carried out in a joint venture with The Heme Foundation. As a next step, the Company intends to proceed with a 14-day repeated dose toxicity study using New Zealand Rabbits and Wistar Rats as funding permits.
Key Strengths
We believe that our key differentiating elements include:
| ● | Focus on novel therapeutic opportunities provided by co-polymer: We are focused on development of co-polymer compounds to stabilize the modified hemoglobin molecule. The Co- polymer method of chemical stabilization has not received as much scientific attention as nucleic acids and proteins, but the Company believes that it is a viable alternative to these other materials. |
|---|---|
| ● | Experienced management |
| - | Our President, Chief Executive Officer and Chairman, David Platt, Ph.D., is a chemical engineer, a pioneer in designing drugs made from co-polymers, and has more than 30 years of experience in the development of therapeutic drugs. We are the fourth biotechnology company founded by Dr. Platt. The prior company is Boston Therapeutics Inc. (OTC: BTHE). The first two are International Gene Group, which later became Prospect Therapeutics, and is now known as La Jolla Pharmaceuticals (Nasdaq: LJPC), and Pro-Pharmaceuticals (now Galectin Therapeutics) (Nasdaq: GALT). Their core technologies were either developed or co-developed by Dr. Platt. |
| - | Our CFO Ola Soderquist has more than 30 years of senior international entrepreneurial management experience within technology companies. Ola’s managerial experience portfolio includes; Start-ups, Private, Public, Venture Capital and Private Equity ownership. He has served in CFO and other managerial capacities in multiple industry sectors and companies. Ola is a multi-lingual senior finance professional poised to work globally and cross-functionally, particularly with complex projects involving change management, business integration, systems implementation, continuous improvement, and process excellence. He obtained a BS and an MS in Accounting from Stockholm School of Economics and an MBA from Babson College. |
| - | We have assembled a scientific and medical advisory board consisting of leading physicians and key opinion leaders who have participated in relevant clinical studies and who will guide us through ongoing clinical trial programs. Our scientific and medical advisory boards consist of some of the leading scientists, medical doctors and professionals in the ischemia or hypoxia fields. |
| ● | Products are differentiated and address significant unmet needs: Our lead product candidate, BXT-25, PL-M, or any future drug candidates will be designed to address significant unmet medical needs. Oxygen therapy management, including stroke, other hypoxia management and treatment of diseases and medical conditions associate with hypoxia, remain a critical area of unmet need. Increasingly, patients, physicians and the media are highlighting the deficiencies of current oxygen therapy related therapies and the growing population of individuals adversely affected by ischemia, unhealed wounds, or traumatic brain injury. |
|---|---|
| ● | Efficient development strategy: We believe that our regulatory development pathway is a standard generic pathway approval for a drug. |
| ● | Risks Associated with Our Business: Our business is subject to numerous significant risks, as more fully described in the section entitled “Risk Factors”. You should read and carefully consider these risks, together with the risks set forth under the section entitled “Risk Factors” and all of the other information in this Confidential Private Placement Memorandum, including the financial statements and the related notes included elsewhere in this Confidential Private Placement Memorandum, before deciding whether to invest in our Common Stock. If any of the risks discussed in this Confidential Private Placement Memorandum actually occur, our business, financial condition or operating results could be materially and adversely affected. In particular, our risks include, but are not limited to, the following: |
| - | We expect to incur losses for the foreseeable future and may never achieve or maintain profitability. |
| - | We are a company with limit operating history which makes it difficult to evaluate our current business and future prospects. |
| - | We will require additional financing to implement our business plan, which may not be available on favorable terms or at all, and we may have to accept financing terms that would adversely affect our stockholders. |
| - | Raising additional capital may cause dilution to our stockholders, restrict our operations or require us to relinquish rights to our drug candidates. |
| - | Our products are based on novel, unproven technologies. |
| - | Clinical drug development involves a lengthy and expensive process, with an uncertain outcome. We may incur additional costs or experience delays in completing, or ultimately be unable to complete, the development and commercialization of our drug candidates. |
| - | We may be unable to commercialize our drug candidates or expand awareness. |
| - | Our success depends upon our ability to retain key executives and to attract, retain, and motivate qualified personnel and direction and the loss of these persons could adversely affect our operations and results. |
| - | our competitive position depends on protection of our intellectual property. We intend to submit more patents and provisional patents in the near future to strengthen our intellectual property. |
| - | The market for our proposed products is rapidly changing and competitive, and new drugs and new treatments which may be developed by others could impair our ability to maintain and grow our business and remain competitive. |
| - | We may become involved in lawsuits to protect or enforce patents that may issue to us, that we may acquire, or may license in the future or other intellectual property, which could be expensive, time-consuming and ultimately unsuccessful. |
| - | The market price of our Common Stock may be highly volatile, and you could lose all or part of your investment. |
| - | We have a limited market for our Common Stock, which makes our securities very speculative. |
| - | You will experience immediate and substantial dilution as a result of our currently effective public offering and may experience additional dilution in the future. |
| - | Our management will have broad discretion in how we use the net proceeds of our currently effective public offering. |
Corporate Information
We are a clinical stage pharmaceutical company founded on June 9, 2008, as America’s Driving Ranges, Inc. On September 21, 2018, the Company was reorganized into Bioxytran through a reverse merger to focus on the development, manufacturing and commercialization of therapeutic drugs designed to address hypoxia in humans, which is a lack of oxygen in tissues.
Our principal executive offices are located at 75 2 nd Ave., Suite 605, Needham, MA 02494.
Smaller Reporting Company Status
The Company meets the smaller reporting company requirements. The Company will report its results in this Annual Report on Form 10-K in accordance with the smaller reporting company requirements and in its reports filed with the SEC.
The text of this filing, as the company filed it with the SEC, without its images or exhibits. This is not investment advice.