Form 8-K - Current report

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): August 21, 2023

BIOXYTRAN, INC.

(Exact Name if Business Issuer as specified in its Charter)

Nevada

001-35027

26-2797630

(State or other Jurisdiction

of Incorporation)

(Commission

File Number)

(IRS Employer

Identification Number)

75, Second Avenue,

Suite 605

Needham MA, 02494

(Address of principal executive offices, including zip code)

(617) 494-1199

(Registrant’s telephone number including area code)

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 1 4a- 12 under the Exchange Act (17 CFR 240.1 4a- 12)

☐	Pre-commencement communications pursuant to Rule 1 4d-2(b) under the Exchange Act (17 CFR 240.1 4d-2(b))

☐	Pre-commencement communications pursuant to Rule 1 3e-4(c) under the Exchange Act (17 CFR 240.1 3e-4(c))

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. ☐

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	OTCPK

Item 8.01 Other Events.

On August 21, 2023, Bioxytran (the “Company”) has through the U.S. Food and Drug Administration (FDA) received permission in form of an investigational new drug application (IND) under the provisions of section 505(i) of the Federal Food, Drug, and Cosmetic Act, to conduct clinical trial(s) with ProLectin-M the registration IND, No. 153742, by stating “We have completed the review of your submission and have concluded that the clinical trial(s) may be initiated”.

In connection of with the above approval the Company issued on August 24, 2023 a press-release over Globe Newswire, under the title:

Bioxytran Announces FDA Clearance of its IND Application for ProLectin-M in Clinical Trials

Item 9.01. Financial Statements and Exhibits.

(d) Exhibits.

Exhibit
Number		Description
99.1		Press-release - Bioxytran Announces FDA Clearance of its IND Application for ProLectin-M in Clinical Trials, dated August 24, 2023.
104		Cover Page Interactive Data File (embedded within the Inline XBRL document)

SIGNATURES

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

	By:	/s/ David Platt
	Name:	Dr. David Platt
	Title:	President and Chief Executive Officer

	Dated: August 24, 2023

Exhibit 99.1

Bioxytran Announces FDA Clearance of its IND Application for ProLectin-M in Clinical Trials

●

First Antiviral Drug in Glycovirology

BOSTON, MASSACHUSETTS, August 24, 2023 (GLOBE NEWSWIRE) — BIOXYTRAN, INC. (BIXT), (the “Company”), a clinical stage biotechnology company developing oral drugs to treat COVID-19 and other viral diseases, announced that it has received clearance of its Investigational New Drug (IND) application from the U.S. Food and Drug Administration (FDA), to initiate clinical trials of ProLectin-M for the treatment of mild to moderate COVID-19 in standard risk patients.

“This clearance of ProLectin-M into the clinic is very important given that this is the first of a number of indications that we intend to pursue to treat large unmet medical needs with our glycovirology technology,” said Dr Leslie Ajayi, Bioxytran Chief Medical Officer. “This is an important milestone for our Company, as it represents our first program to receive FDA clearance to enter the clinic and paves the way for us to pursue other viral indications. This class of galectin inhibitors is groundbreaking because peer reviewed clinical trial results suggest a large number of patients can become PCR negative in as little as 3 days. The drug was designed by Nuclear Magnetic Resonance Spectroscopy technology to neutralize viruses. Even though we are seeing a resurgence of COVID-19 and its newest variants, BA.2.86 and EG.5, we view our COVID-19 trials as case studies designed to showcase the potential of the galectin antagonist as a broad-spectrum antiviral drug.”

About ProLectin-M

ProLectin-M is an oral galectin antagonist that prevents the entry of the SARS-CoV-2 virus into human cells. In recent clinical trials the drug achieved a 100% responders rate of negative PCR tests by day 7. In 3 days, the drug achieved an 88% responders rate of negative PCR tests. The treated population experienced no viral rebounds during the 14-day observation period. The company is preparing for a phase 3 clinical trial in order to seek regulatory approval.

About Bioxytran, Inc.

Bioxytran, Inc. is a clinical stage biotechnology company developing novel therapies targeting 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, 2021 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.

Cover	Aug. 21, 2023
Cover [Abstract]
Document Type	8-K
Amendment Flag	false
Document Period End Date	Aug. 21, 2023
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 Avenue,
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	494-1199
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