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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): March 2, 2026
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
8.01. Other Events
On
March 2, 2026, the Company issued a press-release over Globe Newswire, enclosed hereto as Exhibit 99.1, under the title:
Bioxytran,
Inc. Reports Positive Phase 1b/2a Clinical Study Results for ProLectin-M, a Broad-Range Antiviral Drug in Mild to Moderate COVID-19
Item
9.01 Financial Statements and Exhibits.
Exhibit
Number |
|
Description |
| |
|
|
| 99.1* |
|
Press Release dated March 2, 2026, entitled “Bioxytran, Inc. Reports Positive Phase 1b/2a Clinical Study Results for ProLectin-M, a Broad-Range Antiviral Drug in Mild to Moderate COVID-19”. |
| |
|
|
| 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
March 2, 2026 |
|
EXHIBIT
99.1
Bioxytran,
Inc. Reports Positive Phase 1b/2a Clinical Study Results for ProLectin-M, a Broad-Range Antiviral Drug in Mild to Moderate COVID-19
Randomized,
Double-Blind, Placebo-Controlled Study Demonstrates 90% Day-5 Viral Clearance and Favorable Safety at Highest Dose compared to 20% placebo
control
BOSTON,
MA — Bioxytran, Inc. (OTCQB: BIXT), a clinical-stage biotechnology company developing carbohydrate-based therapeutics, today announced
results from a randomized, double-blind, placebo-controlled Phase 1b/2a clinical study evaluating oral ProLectin-M in hospitalized patients
with mild to moderate COVID-19 caused by SARS-CoV-2.
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.
“We
believe an oral, well-tolerated antiviral with a differentiated mechanism could address important gaps in current treatment approaches,
particularly in early-stage respiratory infections.” said Dr. Leslie Ajayi, Bioxytran’s Chief Medical Officer. “Our
clinical data suggests ProLectin-M demonstrated earlier reductions in viral shedding compared with placebo with a favorable safety profile,
and these findings support further evaluation of ProLectin-M in larger, well-controlled studies to assess its potential role as a first-line
therapy.”
“These
findings provide confirmation of an early clinical trials antiviral effect and support further evaluation of ProLectin-M’s novel
galectin-targeting mechanism,” said David Platt, PhD, CEO of Bioxytran. “The clinical trials results are opening a new horizon
for a new generation of safe anti-viral drugs. We believe the consistency of the observed activity supports continued clinical development
of this oral therapeutic approach.”
Study
Design
The
Phase 1b/2a study enrolled 39 participants in India with RT-PCR-confirmed SARS-CoV-2 infection and mild to moderate disease. Participants
were randomized to receive one of three dose levels of ProLectin-M plus standard of care (SOC), or placebo plus SOC, administered over
five days.
Dose
Arms:
5,600
mg/day ProLectin-M + SOC, 11,200 mg/day ProLectin-M + SOC, 16,800 mg/day ProLectin-M + SOC, Placebo + SOC.
The
primary endpoint evaluated absence of detectable viral RNA at Day 7. Secondary endpoints included earlier viral clearance, changes in
viral load, clinical status improvement, safety, and pharmacokinetics.
Key
Findings
Earlier
Viral Clearance (Day 5)
90%
of participants receiving 16,800 mg/day achieved non-detectable viral shedding by Day 5. It was compared with 20.0% (placebo), 20.0%
(5,600 mg), and 40.0% (11,200 mg). The difference between the 16,800 mg/day cohort and placebo was statistically significant (p=0.001).
Clinical
Improvement
90%
of participants in the highest-dose cohort achieved at least a 2-point improvement on the WHO Ordinal Scale by Day 5 compared with 20.0%,
40.0%, and 20.0% in the lower-dose and placebo groups. All participants improved clinically by Day 7.
Viral
Load Trends
Cycle
threshold (Ct) values increased over time across all groups, consistent with declining viral load. Numerically earlier Ct increases were
observed in the highest-dose cohort beginning as early as Day 3, supporting the observed Day-5 antiviral signal.
Primary
Endpoint Outcome
Because
mild-to-moderate COVID-19 in this population typically resolves within 7 days, the primary endpoint at Day 7 did not differentiate treatment
arms. However, earlier viral clearance observed at Day 5 suggests a potential acceleration of viral resolution.
Safety
and Tolerability
ProLectin-M
was well tolerated at all evaluated dose levels with no serious adverse events, no treatment-related discontinuations, no clinically
meaningful changes in laboratory values, ECGs, or vital signs. High compliance with the 5-day dosing regimen.
Development
Context
ProLectin-M
is designed to target galectins, carbohydrate-binding proteins that certain viruses utilize to attach to and enter host cells. By acting
on host-virus interactions rather than intracellular viral replication, this approach represents a differentiated antiviral strategy
that may have applicability across multiple viral infections. In future studies, ProLectin-M may also be evaluated for its potential
as a preventive therapy. The Company believes these results support continued evaluation of ProLectin-M as a potential oral therapeutic
and provide a foundation for future clinical studies.
About
ProLectin-M
ProLectin-M
is an investigational oral antiviral being developed under an active U.S. Investigational New Drug (IND) framework as well as international
regulatory oversight. The therapy leverages carbohydrate chemistry to block viral entry mechanisms mediated by galectin interactions.
About
Bioxytran, Inc.
Bioxytran,
Inc. is a clinical-stage biotechnology company focused on developing novel carbohydrate-based therapeutics to address significant unmet
medical needs in infectious and cardiovascular diseases.
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, 2024, 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.
For
more information, please visit:
www.bioxytraninc.com
Investor
Contact:
David Platt, PhD
CEO, Bioxytran, Inc.
617-484-1199
David.Platt@bioxytraninc.com
