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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 23, 2026
MANGOCEUTICALS,
INC.
(Exact
name of registrant as specified in its charter)
| Texas |
|
001-41615 |
|
87-3841292 |
(State
or Other Jurisdiction
of Incorporation) |
|
(Commission
File
Number) |
|
(IRS
Employer
Identification No.) |
17130
N. Dallas Parkway, Suite 240
Dallas,
Texas |
|
75248 |
| (Address
of Principal Executive Offices) |
|
(Zip
Code) |
Registrant’s
telephone number, including area code: (214) 242-9619
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
$0.0001 per share |
|
MGRX |
|
The
Nasdaq Stock Market LLC
(Nasdaq
Capital Market) |
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
7.01 Regulation FD Disclosure.
On
February 23, 2026, Mangoceuticals, Inc. (the “Company”, “we” and “us”) issued
a press release announcing new data from field trials and a controlled study regarding its proprietary and patented antiviral compound
MGX-0024, including zero respiratory-related mortality in approximately 29,000-bird commercial poultry field trials in India and prophylactic
benefits against H5N1 in a government-conducted challenge study.
The
press release is furnished as Exhibit 99.1 to this Current Report on Form 8-K and incorporated into this Item
7.01 by reference. The information in this Item 7.01, including Exhibit 99.1 attached hereto, shall
not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended, or otherwise
subject to the liabilities of that section, nor shall it be deemed incorporated by reference in any filing under the Securities Act of
1933, as amended, except as expressly set forth by specific reference in such filing.
Item
9.01 Financial Statements and Exhibits.
(d)
Exhibits.
| Exhibit
Number |
|
Description
of Exhibit |
| 99.1 |
|
Press Release dated February 23, 2026 |
| 104 |
|
Cover Page Interactive
Data File (embedded within the Inline XBRL document) |
Forward-Looking
Statements
This
Current Report and the press release attached as Exhibit 99.1 to this Current Report may contain forward-looking information
within the meaning of applicable securities laws (“forward-looking statements”). These forward-looking statements
represent the Company’s current expectations or beliefs concerning future events and can generally be identified using statements
that include words such as “estimate,” “expects,” “project,” “believe,” “anticipate,”
“intend,” “plan,” “foresee,” “forecast,” “likely,” “will,” “target”
or similar words or phrases. These forward-looking statements are subject to risks, uncertainties and other factors, many of which are
outside of the Company’s control, which could cause actual results to differ materially from the results expressed or implied in
the forward-looking statements. These statements are neither promises nor guarantees, but involve known and unknown risks, uncertainties
and other important factors that may cause actual results, performance, or achievements to be materially different from any future results,
performance, or achievements expressed or implied by the forward-looking statements. The Company undertakes no obligation to publicly
update or revise any of the forward-looking statements, whether because of new information, future events or otherwise, made in the release
or presentation or in any of its SEC filings or public disclosures, except as provided by law. Consequently, you should not consider
any such list to be a complete set of all potential risks and uncertainties. More information on potential factors that could affect
the Company’s financial results is included from time to time in the “Forward-Looking Statements,” “Risk
Factors” and “Management’s Discussion and Analysis of Financial Condition and Results of Operations”
sections of the Company’s periodic and current filings with the SEC, including Form 10-Qs, Form 10-Ks and Form 8-Ks, filed with
the SEC and available at www.sec.gov. Forward-looking statements speak only as of the date they are made.
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.
| |
MANGOCEUTICALS, INC. |
| |
|
|
| Date: February 23, 2026 |
By: |
/s/
Jacob D. Cohen |
| |
|
Jacob D. Cohen |
| |
|
Chief Executive Officer |
Exhibit 99.1
Mangoceuticals’
Patented MGX-0024 Achieves Zero Respiratory-Related Mortality in 29,000-Bird Field Trials and Demonstrates Prophylactic Benefit Against
H5N1 in Controlled Government Study
Dallas,
TX – February 23, 2026 – Mangoceuticals, Inc. (NASDAQ: MGRX), a company focused on developing, marketing, and selling a variety
of health and wellness products via a secure telemedicine platform under the brands MangoRx and PeachesRx, and a pioneer in innovative
wellness solutions, today announced new data from its proprietary antiviral compound MGX-0024. A technical report issued by partner
IntraMont Technologies in late 2025, combined with the final signed report from the ICAR-National Institute of High Security Animal
Diseases (NIHSAD), Bhopal, supports MGX-0024’s potential to reduce respiratory disease impacts in commercial poultry settings and
provide meaningful early protection against highly pathogenic avian influenza (HPAI) H5N1 and other respiratory illnesses like Newcastle’s
disease, IBH, ILT, etc. in birds.
In
three independent commercial field trials conducted on farms in Tamil Nadu, India (Duraiswamy and Raghupati Farms), a total of approximately
29,000 broiler chicken received MGX-0024-infused drinking water starting around day 14 of life through market age (37–48 days),
with no concurrent antibiotics or antivirals used. Across all flocks, zero mortality was attributed to respiratory pathogens, including
viral or bacterial causes such as suspected avian influenza and Mycoplasma infections. Historical farm data and simultaneous neighboring
untreated flocks indicated expected respiratory-related mortality of approximately 50%, or roughly 14,500 birds. All recorded deaths,
which were minimal in number, were linked to non-respiratory causes, primarily heat stress.
These
outcomes build on and expand the earlier May 2025 field studies, which reported zero respiratory-related deaths in treated groups of
approximately 8,000–10,000 birds. The current results replicate that performance across a significantly larger population and multiple
independent sites. Diagnostic confirmation in the field trials relied on clinical observation and farm records; additional PCR or serology
testing was not uniformly applied across all birds due to real-world commercial constraints.
Complementing
the field data, a rigorously controlled challenge study by Vipragen Biosciences and conducted at ICAR-NIHSAD under BSL-3 lab conditions
evaluated MGX-0024 in specific-pathogen-free layered chicks using the highly pathogenic clade 2.3.4.4b H5N1 strain (A/duck/India/11TR05/2021).
Chicks received MGX-0024 via drinking water for 24–48 hours prior to intranasal challenge at a dose of 10⁵ EID₅₀
in the revised Phase II protocol. In the 48-hour pre-treatment group, mortality was reduced by up to 60% compared to untreated controls
(2 out of 7 deaths versus 5 out of 7 in controls). The mean time to death was extended significantly, up to 10.71 days versus 5.86 days
in controls. Surviving birds exhibited only intermittent, low-level viral shedding and remained seronegative for H5 antibodies at day
14, suggesting effective early interference with infection establishment. This small-scale, controlled laboratory study (n=7 per group)
provides encouraging preliminary evidence of prophylactic activity but is not a direct substitute for larger field validation against
natural exposure.
“These
results represent meaningful progress,” said Jim Intrater, President of IntraMont Technologies. “Eliminating observed respiratory-related
mortality in real-world commercial flocks, alongside a clear prophylactic signal in a controlled H5N1 challenge, positions MGX-0024 as
a promising tool for managing endemic respiratory challenges and supporting biosecurity against avian influenza threats.”
MGX-0024
is a GRAS-classified formulation of select polyphenols and zinc, administered through standard farm drinking-water systems. It forms
a persistent physical-chemical barrier in the respiratory tract to inhibit viral attachment and replication, offering a non-vaccine,
non-antibiotic approach. Intellectual property is protected under U.S. Patent No. 11,517,523 and corresponding patents in the EU, Canada,
China, India, Australia, and Japan, with additional applications pending.
Jacob
Cohen, CEO of Mangoceuticals, added: “We continue to advance this program with strong interest from distributors, farms, and agencies
in key markets like India. We are scaling production, refining pricing and logistics, while our partner IntraMont Technologies is actively
engaging in regulatory discussions in the United States, Australia, UK, Canada, and elsewhere. This aligns well with global trends toward
reduced antibiotic use and sustainable poultry production.”
Mangoceuticals
and IntraMont are planning further multi-farm studies in India and pursuing grant opportunities through USDA, BARDA, and international
equivalents. Commercial discussions and potential rollout activities are underway, with targeted availability in select markets anticipated
in the coming periods.
For
inquiries, contact info@mangorxipholdings.com or visit www.MangoRxIPHoldings.com.
Study
Disclaimer
The
field trial results for MGX-0024 described herein are based on commercial studies commissioned and funded by Mangoceuticals, Inc., in
collaboration with partners including Solice International and IntraMont Technologies. The controlled H5N1 challenge study was conducted
at ICAR-NIHSAD under BSL-3 conditions, sponsored by Vipragen Biosciences. While the Company believes these results are accurate and represent
meaningful advancements, they remain preliminary in certain aspects—particularly the small sample size in the H5N1 lab study—and
are subject to further independent validation, larger-scale field trials, and regulatory review. Efficacy against natural outbreaks or
specific pathogens (including HPAI H5N1) may vary by environment, flock conditions, diagnostic methods, and other factors. No claims
of approved veterinary use or broad-spectrum efficacy have been authorized by regulatory authorities.
This
press release contains forward-looking statements, including but not limited to statements about the potential efficacy, commercial rollout,
and regulatory approval of MGX-0024, as well as its impact on poultry farming and biosecurity. These statements are subject to risks
and uncertainties, including the outcomes of ongoing and future studies, regulatory approvals, market acceptance, and the ability to
scale production and distribution. There is no guarantee that MGX-0024 will achieve the same results in other settings or receive regulatory
approval in key markets. The Company’s plans to engage with regulatory authorities, secure funding, and expand studies are aspirational
and may not materialize as anticipated. See also “Cautionary Note Regarding Forward-Looking Statements”, below.
Mangoceuticals,
Inc. has not independently verified the data provided by Solice International, and investors and stakeholders are cautioned not to place
undue reliance on these preliminary results. For further details on the study methodologies and results, please contact info@mangorxipholdings.com.
The Company undertakes no obligation to update or revise any forward-looking statements, except as required by applicable law.
A
link to the complete study can be found here or by visiting the website at www.MangoRxIPHoldings.com.
About
Mangoceuticals, Inc.
MangoRx
is focused on developing a variety of men’s health and wellness products and services via a secure telemedicine platform. To date,
the Company currently offers pharmaceutical-based products specifically related to the treatments of erectile dysfunction, hair growth,
hormone replacement therapies, and weight management. Interested consumers can use MangoRx’s telemedicine platform for a smooth
experience. Prescription requests will be reviewed by a licensed medical provider and, if approved, fulfilled and discreetly shipped
through MangoRx’s partner compounding pharmacy and right to the patient’s doorstep. To learn more about MangoRx’s mission
and other products, please visit www.MangoRx.com.
Cautionary
Note Regarding Forward-Looking Statements
Certain
statements made in this press release contain forward-looking information within the meaning of applicable securities laws, including
within the meaning of the Private Securities Litigation Reform Act of 1995 (“forward-looking statements”). These forward-looking
statements represent the Company’s current expectations or beliefs concerning future events and can generally be identified using
statements that include words such as “estimate,” “expects,” “project,” “believe,” “anticipate,”
“intend,” “plan,” “foresee,” “forecast,” “likely,” “will,” “target”
“up to” or similar words or phrases. These forward-looking statements include, but are not limited to, the review and evaluation
of strategic transactions and their impact on shareholder value; the process by which the Company engages in evaluation of strategic
transactions; the outcome of potential future strategic transactions and the terms thereof; macroeconomic, industry and market conditions,
including inflation, interest rate volatility, recessionary trends, financial market disruptions, changes in regulatory or political
environments, and other factors beyond the Company’s control that could adversely affect its business, financial condition and
results of operations; our ability to meet the continued listing requirements of Nasdaq and maintain the listing of our common stock
on Nasdaq, including as a result of our current non-compliance with certain listing standards relating to our stock price; our ability
to successfully undertake a crypto treasury strategy in the future; risks related to the significant number of shares in the public float,
our share volume, the effect of sales of a significant number of shares in the marketplace; dilution caused by offerings; conversion
of outstanding shares of preferred stock and the rights and preferences thereof, the fact that we have a significant number of outstanding
warrants to purchase shares of common stock and other convertible securities, the resale of which underlying shares have been registered
under the Securities Act of 1933, as amended, dilution caused by exercises/conversions thereof, overhang related thereto, and decreases
in the trading price of our common stock caused by sales thereof; our ability to build and maintain our brands; cybersecurity, information
systems, fraud and website risks; compliance with applicable laws and regulations affecting our operations, products, marketing, manufacturing,
labeling and distribution; shipping, production and supply chain delays; reliance on third parties for prescribing, compounding and other
key services; product safety risks; macroeconomic and geopolitical conditions, including inflation, interest rates, recessions, pandemics,
acts of war, tariffs and trade disruptions; protection of intellectual property; our ability to attract and retain key personnel; potential
stock overhang and volatility in the trading price of our common stock; and consumer sentiment and discretionary spending trends. Although
we believe that our plans, intentions and expectations reflected in or suggested by the forward-looking statements we make in this release
are reasonable, we provide no assurance that these plans, intentions or expectations will be achieved. Consequently, you should not consider
any such list to be a complete set of all potential risks and uncertainties.
More
information on potential factors that could affect the Company’s financial results is included from time to time in the “Cautionary
Note Regarding Forward-Looking Statements,” “Risk Factors” and “Management’s Discussion and Analysis of
Financial Condition and Results of Operations” sections of the Company’s filings with the SEC, including the Company’s
Annual Report on Form 10-K for the year ended December 31, 2024 and our Quarterly Report on Form 10-Q for the quarter ended September
30, 2025, and subsequent reports. These filings are available at www.sec.gov and at our website at https://www.mangoceuticals.com/sec-filings
. All subsequent written and oral forward-looking statements attributable to the Company or any person acting on behalf of the Company
are expressly qualified in their entirety by the cautionary statements referenced above. Other unknown or unpredictable factors also
could have material adverse effects on the Company’s future results. The forward-looking statements included in this press release
are made only as of the date hereof. The Company cannot guarantee future results, levels of activity, performance or achievements. Accordingly,
you should not place undue reliance on these forward-looking statements. Finally, the Company undertakes no obligation to update these
statements after the date of this release, except as required by law, and takes no obligation to update or correct information prepared
by third parties that are not paid for by the Company. If we update one or more forward-looking statements, no inference should be drawn
that we will make additional updates with respect to those or other forward-looking statements.
FOR
INVESTOR RELATIONS
Mangoceuticals
Investor Relations
Email:
investors@mangorx.com
