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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): February 11, 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
February 11, 2026, the Company issued a press-release over Globe Newswire, enclosed hereto as Exhibit 99.1, under the title:
Bioxytran
Reports Positive Phase 2 Results Demonstrating Rapid Viral Clearance with ProLectin-M
Item
9.01 Financial Statements and Exhibits.
Exhibit
Number |
|
Description |
| |
|
|
| 99.1* |
|
Press Release dated February 11, 2026 entitled “Bioxytran Reports Positive Phase 2 Results Demonstrating Rapid Viral Clearance with ProLectin-M”. |
| |
|
|
| 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
February 11, 2026
Exhibit
99.1
BIOXYTRAN
REPORTS POSITIVE PHASE 2 RESULTS
DEMONSTRATING
RAPID VIRAL CLEARANCE WITH PROLECTIN-M
Trial
reports complete elimination of viral load in 100% of patients at day 7 versus placebo (p=.001)
BOSTON,
MASSACHUSETTS — Feb 11, 2026 — Bioxytran, Inc. (OTCQB: BIXT) today announced positive clinical results from its recently
completed Phase 2 randomized, double-blind, placebo-controlled, dose-optimization trial evaluating ProLectin-M in subjects with laboratory-confirmed
acute viral infection.
The
completed Phase 2 clinical study was a randomized, double-blind, placebo-controlled, dose-optimization trial evaluating orally administered
ProLectin-M in subjects with acute viral infection. The study enrolled 38 subjects, all of whom completed the study. Subjects were randomized
to receive one of three ProLectin-M dose levels or a matching placebo, administered over a seven-day treatment period.
Viral
shedding was assessed using RT-PCR analysis of nasopharyngeal swabs collected at predefined timepoints, with viral clearance defined
as non-detection of viral RNA below established PCR thresholds.
The
study design, endpoints, and duration confirmed Bioxytran’s earlier randomized, placebo-controlled Phase 2 trial, which demonstrated
statistically significant reductions in viral load by Day 7, early clearance as soon as Day 3, and no observed viral rebounds during
a 14-day post-treatment observation period. The current trial further refined dose selection of four tablets per day and evaluated the
reproducibility of rapid viral clearance using the same core virologic assessment methodology.
Topline
Viral Clearance Results
Following
database lock and unblinding, treatment-wise analyses demonstrated the following outcomes:
| ● | Complete elimination
of viral load in 100% of treated subjects by Day 7, compared to the placebo group (p = .001) |
| | |
| ● | No viral rebounds
observed in the treated population during the 14-day post-treatment observation period |
These
results indicate rapid and sustained viral clearance in subjects treated with ProLectin-M.
Viral
Clearance Timing (All Subjects)
Across
the full study population:
| 1. | Day 3: 1 of 38
subjects demonstrated non-detection of viral shedding |
| 2. | Day 5: 16 of 38
subjects demonstrated non-detection of viral shedding |
| 3. | Day 7: 38 of 38
subjects demonstrated non-detection of viral shedding |
The
study was designed to evaluate viral clearance kinetics and inform dose selection for future late-stage clinical development.
“The
study design of seven days reflects real-world applications for treating acute viral diseases, with the objective of demonstrating a
statistically meaningful reduction in viral load by Day 7,” said Dr. Leslie Ajayi, Chief Medical Officer of Bioxytran. “The
results demonstrate that viral clearance occurred more rapidly than anticipated, with a significant proportion of treated subjects achieving
viral non-detection by Day 3 and complete clearance by Day 7.”
“What
continues to distinguish ProLectin-M as a broad-range antiviral drug is its novel mechanism of action,” Dr. Platt continued. “Rather
than targeting viral replication inside the cell, our galectin antagonist is designed to interfere with viral entry at the cell surface.
This extracellular approach may reduce reliance on immune activation and represents a fundamentally different strategy in antiviral therapy.
We believe these results further support the potential of carbohydrate-based therapeutics and the emerging field of Glycovirology.”
Next
Steps
Based
on these results, Bioxytran plans to advance regulatory discussions to support late-stage clinical development and evaluate ProLectin-M
across additional viral indications consistent with its broad-spectrum antiviral profile.
About
Bioxytran, Inc.
Bioxytran,
Inc. is a clinical-stage biotechnology company developing novel carbohydrate-based therapeutics targeting significant unmet medical needs
in virology and other disease areas. The Company’s lead program, ProLectin-M, is being developed as a potential broad-spectrum
antiviral therapeutic.
For
more information, please visit www.bioxytraninc.com.
Investor
& Media Contact:
Bryan
Feinberg / AmplifiX
Zephyr@amplifiX.net
Company
Contact:
david.platt@bioxytraninc.com
(617)
510-2539
Forward-Looking
Statements
This
press release contains forward-looking statements within the meaning of applicable federal securities laws, including statements regarding
the performance of the technology described herein, the interpretation of clinical trial results, regulatory plans, and future development
activities. Forward-looking statements are generally identified by words such as “believe,” “expect,” “anticipate,”
“estimate,” “intend,” “plan,” and similar expressions, although not all forward-looking statements
include these terms. Such statements are subject to significant risks, uncertainties, and assumptions that could cause actual results
to differ materially from those expressed or implied. These risks are described in Bioxytran’s filings with the Securities and
Exchange Commission, including its Annual Report on Form 10-K for the fiscal year ended December 31, 2024, and other filings made from
time to time. Bioxytran undertakes no obligation to update or revise any forward-looking statements, except as required under applicable
securities laws.
