BIXT Bioxytran Inc (QB)

 

 

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

 

FORM 8-K

 

CURRENT REPORT PURSUANT TO SECTION 13 OR 15(d)

OF THE SECURITIES EXCHANGE ACT OF 1934

 

Date of Report (Date of earliest event reported): July 15, 2024

 

BIOXYTRAN, INC.

(Exact Name of Registrant as Specified in Charter)

 

Nevada		001-35027		26-2797630
(State or Other Jurisdiction		(Commission		(IRS Employer
of Incorporation)		File Number)		Identification Number)

 

75 Second Ave, Suite 605, Needham, MA		02494
(Address of Principal Executive Offices)		(Zip Code)

 

Registrant’s telephone number, including area code 617-454-1199

 

(Former Name or Former Address, if Changed Since Last Report)

 

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions (see General Instruction A.2. below):

 

☐	Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

 

☐	Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

 

☐	Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

 

☐	Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

 

Securities registered pursuant to Section 12(b) of the Act:

 

Title of each class		Trading Symbol(s)		Name of each exchange on which registered
Common Stock, par value $0.001		BIXT		OTCQB

 

Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).

 

Emerging growth company ☐

 

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐

 

 

 

Item 1.01 Entry into a Material Definitive Agreement

 

On July 15, 2024, Bioxytran (the “Company”) entered into a Joint Venture Agreement (“JV Agreement”) with the Heme Foundation¹ (“Heme”), and NDPD Pharma, Inc.² (“NDPD”). The JV Agreement outlines each partners contribution and right in the development of the Universal Oxygen Carrier (“UOC”).

 

Bioxytran’s Universal Oxygen Carrier represents a potential paradigm shift in transfusion medicine and life-saving blood oxygenation therapy. The inception of UOC began with a profound understanding of the physiological mechanisms governing oxygen delivery. Insights into carbohydrate science have led to the creation of this revolutionary product, making UOC essentially invisible to the human immune system. As a result, UOC circumvents the issue of immune rejection commonly found with other blood substitutes.

 

UOC is a hemoglobin-based oxygen carrier (“HBOC”) designed to mimic the oxygen transportation function of red blood cells. The first HBOC was discovered in the mid-1930’s. While HBOC’s show promise as a blood alternative, there are side-effects associated with HBOC’s, such as high blood pressure, and the risk of organ damage. Unlike other HBOC’s, treatment with UOC has shown no known side-effects in any studies.

 

UOC uses a heme-carbohydrate complex, which involves the separation of the heme group from the globin portion of the hemoglobin molecule. This complex is then linked to a carefully selected sugar molecule that protects the heme, creating a stable oxygen-carrying molecule thousands of times smaller than a red blood cell. The size differential is pivotal, potentially allowing UOC to traverse the circulatory system with greater ease and deliver oxygen more efficiently to hypoxic tissues. UOC can be used with patients of all blood types and has an expected half-life of 18 hours. Bioxytran’s UOC is also shelf-stable, requiring no refrigeration and with a storage life of 5+ years in liquid or dehydrated form.

 

The development cost is estimated to between twenty- to twenty-five million dollars ($20,000,000 to $25,000,000), over a three and a half to five-year period (3.5-to-5-year). To date, the JV has invested over two million dollars ($2,000,000) in prototypes and in the development of compounds. The Heme Foundation has initially allocated ten million dollars ($10,000,000) for the project.

 

Bioxytran has in collaboration with NDPD formulated and manufactured the carbohydrate compound that is linked to the HBOC. NDPD has further accomplished developing a manufacturing prototype, where the production of UOC has been validated in two successful small scale animal trials. NDPD is currently initiating the lyophilization (freeze-drying) of compound, and has also established the protocol for an upcoming large scale 14-day repeated dose toxicology study, in two animal species.

 

1. The Heme Foundation is a 501(c)(3) nonprofit founded in 2021 and based in Bethlehem, Pennsylvania, with a mission “To Solve the Worlds Blood Shortage”. https://hemefoundation.org/donate/

 

2. NDPD Pharma, Inc. is an affiliate of the Company founded in 2017. NDPD specializes in prototyping and development of specialized manufacturing development of specialized equipment for pharmaceutical manufacturing, and in the development of carbohydrate molecules deriving from partially hydrolyzed guar gum or PHGG. The beneficial ownership includes the Company’s officers.

 

 

Item 8.01. Other Events

 

On Thursday, July 18, 2024, the Company will issue a press-release in reference to the JV Agreement mentioned in item 1.01, above. The press-release will be published over GlobeNewswire under the title:

 

Bioxytran Launches Joint Venture with the Heme Foundation for Development of a Universal Oxygen Carrier

 

Item 9.01 Financial Statements and Exhibits.

 

Exhibit Number		Description
10.84*		Joint Venture Agreement between Bioxytran, the Heme Foundation and NDPD Pharma, dated July 15, 2024
99.1*		Press Release dated July 18, 2024 entitled “Bioxytran Launches Joint Venture with the Heme Foundation for Development of a Universal Oxygen Carrier”
104*		Cover Page Interactive Data File (embedded within the Inline XBRL document)

 

*	Filed as an exhibit hereto.

 

 

SIGNATURES

 

Pursuant to the requirements of the Securities Exchange Act of 1934, the Registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.

 

	BIOXYTRAN, INC.
	By:	/s/ David Platt, Ph.D.
		David Platt, Ph.D., its Chief Executive Officer
Date July 17, 2024

 

 

 

Exhibit 10.84

 

Confidential Term Sheet

 

July 15, 2024

 

Partner #1:

Bioxytran, Inc. (“BIXT” or the “Company”)

 

Partner #2:

The Heme Foundation (“Heme” or the “Investor”)

 

Partner #3:

NDPD Pharma, Inc. (“NDPD” or the “Manufacturer”), and/or its assigns as designated by NDPD.

 

Investment:

The terms set forth below are indicative only and subject to review and acceptance of the Company and the Investor.

 

Joint Venture:

The parties agree to form a Joint Venture (“JV”) for the development, manufacturing and distribution of the Universal Oxygen Carrier (“UOC”) for use in transfusion medicine and life-saving blood oxygenation therapy.

 

Contributions:	Bioxytran, Inc.	The Company will also contribute the expertise and knowledge to validate products for distribution based on indications of use of UOC. The Company shall submit a patent registration and establish a non-exclusive distribution agreement to Heme, limited to the use of UOC in transfusion and blood oxygenation, for organizations operating under civilian authority. Further, the Company shall establish a non-exclusive distribution right to the NDPD, limited to the use of UOC in transfusion and blood oxygenation, for organizations operating under military authority as well as an unlimited right of manufacturing.
	Heme Foundation	The Investor shall initially contribute up to $10 million in capital for validation as per the agreed budget.
	NDPD Pharma, Inc.	The Manufacturer shall develop an initial prototype and make a validated proof-of-concept trial. Upon successful outcome the Manufacturer will develop a process for lyophilization (freeze-drying) of the compound, clinical protocols, and the establishment of a GMP compliant facility.
Obtained Rights:	Bioxytran, Inc.	Patent Rights and Exclusive (except were elsewhere stated) and Unlimited Exploitation Rights;
		–	UOC
		–	PLI
		–	MDX Viewer (in clinical trial setting) – license agreement dated April 4, 2019
	Heme Foundation	Distribution Rights for Civilian Institutions;
		–	UOC (transfusion medicine and blood oxygenation therapy)
		–	MDX Viewer (in clinical setting) – in separate agreement
	NDPD Pharma, Inc.	Unlimited Rights of Manufacturing, and Distribution Rights for Institutions under Military Authority;
		–	UOC
		–	Carbohydrate Excipient (“PLI”)

 

Project Supervision:	The therapeutic development of UOC will be managed by the Company, while the manufacturing will be managed by NDPD.
Budget of JV:	The Investor will fund the JV on the following budget:

 

●

Stage One – One Year ($1.5M)

 

	○	Funding to be initiated 20 days after signing and advanced on a budgeted/approved basis.
	○	Hiring of Project Manager and to locate a prototype development site
	○	Development of carbohydrate molecule to be linked to the hemoglobin-based oxygen carrier (“HBOC”).
	○	Development of initial manufacturing prototype.
	○	Small scale animal trial for product validation.
	○	Use of funds for manufacturing of drug, auditing, and testing, and invitro testing.
	○	Milestones: Initial in-vivo results, i.e. knowing it works, “go or no go” decision.

 

 

●

Stage Two - Four to Six Months ($1.5M)

 

	○	Funding to be advance on a budgeted/approved basis upon completion of Stage One.
	○	Lyophilization of compound
	○	Large-scale in-vivo testing in animals (toxicity and efficacy).
	○	Nuclear Magnetic Residence testing.
	○	Pre-IND submission with the Indian Central Drugs Standard Control Organisation (“CDSCO”).
	○	Development of GLP manufacturing.
	○	Start-up funding for MDX.
	○	Milestones: Drug show efficacy in animals, “go or no go” decision.

 

●

Stage Three –Six to Twelve months ($6.0 – 7.5M)

 

	○	Funding to be advanced on a budgeted/approved basis commencing at the end of Stage Two.
	○	Development of GMP manufacturing.
	○	Modernization of the MDX-Viewer.
	○	Sites selection for human trials.
	○	Respond to feedback and protocols from IND.
	○	Milestones: GMP manufacturing completed and MDX-Viewer tested in hospital setting, “go or no go” decision.

 

●

Stage Four – Four to Six Months ($2.0 – 2.5M)

 

	○	Funding to be advanced on a budgeted/approved basis commencing at the end of Stage Three.
	○	Phase I clinical trials (non-toxicity) in healthy volunteers.
	○	Clinical trial for 200 patients at an estimated cost of $65,000 per patient.
	○	Milestones: Drug show non-toxicity in humans, “go or no go” decision.

 

●

Stage Five – Four to Six Months ($3.0 – 4.0M)

 

	○	Funding to be advanced on a budgeted/approved basis commencing at the end of Stage Four.
	○	Clinical trial for 200 patients at an estimated cost of $65,000 per patient.
	○	Milestones: Drug show efficacy in humans, “go or no go” decision.

 

●

Stage Six – 12 to 18 Months ($6.0 – 8.0M)

 

	○	Funding to be advanced on a budgeted/approved basis commencing at the end of Stage Five.
	○	Clinical trial for 400 patients at an estimated cost of $65,000 per patient.
	○	Regulatory Review and Approval.
	○	Market Preparation and Post-Approval Studies.

 

“No Go” Decision:

Should a “no go” decision be reached at the end of any stage indicating the failure of UOC for transfusion and blood oxygenation, the JV will terminate and any remaining monetary assets distributed equally between the partners, while any equipment and IP rights will remain in Bioxytran.

 

Conditions:

The transactions contemplated hereby will be subject to customary closing conditions, including, but not limited to:

 

	–	Satisfactory results of business, tax, legal, environmental and regulatory due diligence, as determined by Heme in its sole discretion;
	–	The parties agreeing upon and executing and delivering the Definitive Agreements;
	–	Notes on terms satisfactory to the parties;
	–	Receipt of any required governmental and third-party consents;
	–	Absence of injunction, litigation, etc.; and
	–	No material adverse change.

 

Confidentiality:

This Term Sheet is confidential, and none of its provisions or terms shall be disclosed to anyone who is not a prospective purchaser of the securities contemplated herein, an officer or director of the Company or such party’s respective agents, advisers or legal counsel, unless required by law. Heme shall continue to be under the confidentiality obligations set forth in the Confidentiality Agreement entered into with the Company on July 12, 2024.

 

Definitive Agreements:

Mutually acceptable definitive agreements will be initially prepared by Bioxytran’s counsel, which will include agreements covering the above items described in this term sheet and such other terms as may be mutually acceptable to the parties thereto (the “Definitive Agreements”). The Definitive Agreements will contain other customary and appropriate terms in addition to the terms set forth herein and agreed upon by the parties.

 

Governing Law:

State of Delaware.

 

 

Due Diligence:

This term sheet is subject to the satisfactory completion of due diligence by the Company, the Investor and the Manufacturer and their affiliates. NDPD, Heme and their representatives will be provided reasonable access at reasonable times to the books, records, financial statements, contracts, internal financial reports and projections, other materials and assets, as well as key personnel, as reasonably requested to allow the Investor and its affiliates to adequately complete their due diligence examination. The Company’s representatives will cooperate with NDPD, Heme and their representatives in connection with their due diligence investigation.

 

Costs and Expenses:

The Company shall promptly reimburse NDPD and Heme for all reasonable out of pocket fees, costs and expenses incurred by NDPD and Heme relating to the transactions described herein to fund the investment, including expenses related to the due diligence investigation as well as the preparation and negotiation of the agreements and other documentation related to the issuance and sale of the Parts, which shall not exceed $25,000. Such expenses to be reimbursed only if the Closing occurs and such amounts being paid to NDPD and Heme at the Closing.

 

Transaction Fee:

NDPD, or its assigns shall be entitled to a Structuring and Management Fee of 6% to be paid by the JV on a prorated basis as funds are advanced at each stage for the first $10,000,000 adv to the JV.

 

NDPD,

Heme and the Company will agree to payment of any other Finders or engagement of Investment Bankers, if funding above and beyond initial budget will be required.

 

General:

The Company can issue a press release or other public announcement regarding this transaction (including a Form 8-K), provided that the Company shall provide NDPD and Heme two (2) days prior written notice and opportunity to review and provide reasonable comments to such press release and Form 8-K, provided however, such review and right to comment of NDPD’s and Heme’s shall not prevent the Company from proceeding with any such filing in order to complying with its filing and disclosure obligations under applicable law.

 

This Term Sheet reflects the principal terms of the transactions contemplated hereby. Notwithstanding any prior corporate approvals of this Term Sheet or any other action, no party or any of its affiliated companies, or the officers, directors or agents of any of them will have any legal obligation (except the obligation to negotiate in good faith and finalize the definitive agreements, subject only to the specific contingencies and including all of the transaction terms described in this Term Sheet) to any other party or any other person or entity by reason of this Term Sheet or any other matter contemplated hereby or giving rise hereto, until the parties execute definitive agreements providing for the transactions contemplated hereby; provided that the terms under section titled Confidentiality and Exclusivity shall be binding on the parties.

 

+++ SIGNATURES ON TH FOLLOWING PAGE +++

 

 

 

Exhibit 99.1

 

Bioxytran Launches Joint Venture with the Heme Foundation for Development of a Universal Oxygen Carrier

 

The Heme Foundation and Bioxytran join forces to address the global blood supply shortage with a blood substitute

 

BOSTON, MASSACHUSETTS, July 18, 2024 (GLOBE NEWSWIRE) -- BIOXYTRAN, INC. (OTCQB: BIXT) (the “Company”), a clinical stage biotechnology company developing oral and intravenous drugs to treat COVID-19, other viral diseases, and stroke, is pleased to announce a Joint Venture (the “JV”) with the Heme Foundation (“Heme” or the “Foundation”) to develop a Universal Oxygen Carrier (“UOC”) as an alternative to blood transfusions. Bioxytran will retain all intellectual property regarding this agreement and the Foundation will be granted a right of use for blood transfusion in exchange for their pledge of up to $10 million over the course of the project’s development. To date, the JV has invested over $2 million in prototypes and in the development of compounds.

 

Bioxytran has formulated and manufactured the building blocks of the UOC made of a complex carbohydrate compound. The Company has also developed a pilot manufacturing line for the UOC. Two successful small scale animal trials in mice and rabbits have validated the UOC. Bioxytran has also established the protocol for an upcoming large scale 14-day repeated dose toxicology study in two animal species.

 

The Heme Foundation’s financial support will continue to help advance the development of the UOC as a blood substitute for blood transfusions, including the manufacturing of the molecule as well as the execution of preclinical and clinical trials.

 

The Heme Foundation is dedicated to solving the world’s blood shortage. Heme has amassed a team that is dedicated to making sure that everyone in the world has access to lifesaving transfusions. The Foundation has determined that Bioxytran’s UOC is one of the most promising blood substitute technologies that is capable of ending the worlds blood shortage. The UOC is expected to be compatible with all blood types, will not have to be screened for pathogens, and has an extended shelf life at room temperature. The infrastructure required to replenish blood inventory in remote regions is a significant cause of medical care inequity, especially when blood is not available. Red blood cell transfusions are essential in many medical procedures, but managing the donation, processing, testing, storage, distribution, and finally the transfusion is a complex and expensive process.

 

Red blood cells can be kept for 21 days which means that keeping a fresh supply can be challenging when taking into consideration potential power outages, natural disasters, pandemics, conflicts, and under-developed supply.

 

Bioxytran’s UOC represents a potential paradigm shift in transfusion medicine and life-saving blood oxygenation therapy. The inception of UOC began with a profound understanding of the physiological mechanisms governing oxygen delivery. Insights into carbohydrate science has led to the creation of this revolutionary product, making UOC’s essentially invisible to the human immune system. As a result, the UOC circumvents the issue of immune rejection commonly found with other blood substitutes. The UOC is a hemoglobin-based oxygen carrier (“HBOC”) designed to mimic the oxygen transportation function of red blood cells.

 

The first HBOC was discovered in the mid-1930’s. While HBOC’s show promise as blood substitutes, there are side-effects associated with HBOC’s, such as high blood pressure, and the risk of organ damage. Unlike other HBOC’s, treatment with UOC’s has not shown any known side-effects in any studies.

 

The UOC uses a heme-carbohydrate complex, which involves the separation of the heme from the globin chains of the hemoglobin molecule. UOCs can be used with patients of all blood types and has an expected half-life of 18 hours. Bioxytran’s UOC is also shelf-stable, requires no refrigeration and has a storage life of 5+ years in liquid or dehydrated form.

 

“This is a game changing technology that has other applications beyond using it as a blood substitute,” said Leslie Ajayi, Chief Medical Officer of Bioxytran, Inc. “Another strategy to increase the body’s oxygenation is through hyperbaric oxygen therapy (“HBOT”). We have what amounts to the equivalent of 18 hours of HBOT in an intravenous shot without the side effects. Typically, the body can only tolerate slightly over one hour of HBOT treatment, but the UOC can significantly amplify those benefits seen with traditional HBOT which includes wound healing, ischemia, anemia, dementia, and Alzheimer’s disease. The core technology behind the UOC was initially used in the development of BXT-25 which is focused on stroke, Alzheimer’s disease, and pulmonary fibrosis. We are at the point where we can revolutionize blood transfusions by offering a blood substitute, especially crucial in remote areas lacking proper supply chains and infrastructure.”

 

 

About the Heme Foundation

 

The Heme Foundation is a 501(c)(3) nonprofit founded in 2021 and based in Bethlehem, Pennsylvania. Their mission is to provide the world with an alternative for blood transfusions using UOC to eliminate the need for a complex supply chain and to abate the cold chain storage requirements for lifesaving blood transfusions. https://hemefoundation.org/donate/

 

About Bioxytran, Inc.

 

Bioxytran, Inc. is a clinical stage biotechnology company pioneering a library of novel carbohydrate structures using artificial intelligence software that interprets the Nuclear Magnetic Resonance imaging of druggable targets like the galectin fold to create a rational drug design. The leading drug candidates vetted by in vitro testing, are capable of neutralizing viruses. The peer-reviewed discovery of the galectin fold located on the spike proteins of upper respiratory viruses, such as COVID-19, RSV and H1N1, demonstrate there exists a conserved region on the spike in which Bioxytran’s molecules achieve virus neutralization. The extent of the carbohydrate structure’s ability to neutralize untested viruses is unknown just like the initial discovery of antibiotics last century and its ability to treat a broad spectrum of bacterial infections. Applications of this platform technology extend to the treatment of significant unmet medical needs in virology, degenerative disease, and hypoxia. The leading drug candidate, Prolectin-M, is a new class of antiviral drug designed to antagonize galectins implicated in inflammatory, fibrotic, and malignant diseases. Bioxytran’s other development programs are for pulmonary fibrosis and stroke treatment. More information can be found at www.bioxytraninc.com

 

Investor Relations

Michael Sheikh

509-991-0245

mike.sheikh@bioxytraninc.com

 

Forward-Looking Statements

 

This press release includes forward-looking statements as defined under federal law, including those related to the performance of technology described in this press release. These forward-looking statements are generally identified by the words “believe,” “expect,” “anticipate,” “estimate,” “intend,” “plan,” and similar expressions, although not all forward-looking statements contain these identifying words. Such statements are subject to significant risks, assumptions and uncertainties. Known material factors that could cause Bioxytran’s actual results to differ materially from the results contemplated by such forward-looking statements are described in the forward-looking statements and risk factors in the Company’s Annual Report on Form 10-K for the fiscal year ended December 31, 2023, and those risk factors set forth from time-to-time in other filings with the Securities and Exchange Commission. Bioxytran undertakes no obligation to correct or update any forward-looking statement, whether as a result of new information, future events, or otherwise, except to the extent required under federal securities laws.

 

 

v3.24.2

Cover	Jul. 15, 2024
Cover [Abstract]
Document Type	8-K
Amendment Flag	false
Document Period End Date	Jul. 15, 2024
Entity File Number	001-35027
Entity Registrant Name	BIOXYTRAN, INC.
Entity Central Index Key	0001445815
Entity Tax Identification Number	26-2797630
Entity Incorporation, State or Country Code	NV
Entity Address, Address Line One	75 Second Ave
Entity Address, Address Line Two	Suite 605
Entity Address, City or Town	Needham
Entity Address, State or Province	MA
Entity Address, Postal Zip Code	02494
City Area Code	617
Local Phone Number	454-1199
Written Communications	false
Soliciting Material	false
Pre-commencement Tender Offer	false
Pre-commencement Issuer Tender Offer	false
Title of 12(b) Security	Common Stock, par value $0.001
Trading Symbol	BIXT
Entity Emerging Growth Company	false

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