MGRX Mangoceuticals Inc

Mangoceuticals, Inc. (NASDAQ: MGRX) ("Mangoceuticals" or the "Company"), 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, is excited to share groundbreaking results from field studies based on its patented antiviral compound which it refers to as “MGX-0024”. The field studies were conducted by Solice International at Duraiswamy Farm in Palladam, Tamil Nadu, India. These studies, targeting respiratory diseases in chickens, like Newcastle Disease and Chronic Respiratory Disease (CRD), showed MGX-0024, delivered through drinking water, achieved 100% survival against respiratory illnesses in a large-scale trial, offering a promising solution for poultry health and avian flu defense.

In the first study, 8,000 chickens starting at 25 days old received MGX-0024-infused water, resulting in about 50 deaths per day from respiratory diseases, compared to 200 per day on a neighboring untreated farm using the same chick batch (used as a control). The farm noted that some deaths may have been due to pre-infected chickens too weak to drink the treated water. In a second study, 10,000 chicks treated from 7 days old, for 48 days, with no other antibacterial or antiviral feed additives administered, had no deaths from respiratory diseases, despite an expected 50% mortality rate (5,000 deaths) based on a nearby farm’s losses (which served as the control). Only 20 chickens died due to unrelated heat exposure. MGX-0024, a blend of natural polyphenols and zinc, Generally Recognized as Safe (GRAS) ingredients, is also under evaluation for use in preventing avian flu (H5N1) in a lab study with Vipragen Biosciences and an Indian government laboratory, with results expected soon. A link to the complete study can be found here or by visiting www.MangoRxIPHoldings.com.

The results of the studies demonstrate significant reductions in mortality due to respiratory diseases compared to untreated neighboring farms, with no respiratory disease-related deaths in the second trial.

We believe that MGX-0024 provides a vaccine- and antibiotic-free way to protect poultry, aligning with global antibiotic restrictions, including India’s ban effective April 2025, the EU’s 2022 ban, and the US’s 2017 ban on antibiotic growth promoters. “We believe that MGX-0024 is a safe, non-toxic, all natural, easy-to-use solution that could revolutionize poultry farming by keeping flocks healthy without the use of drugs or vaccines,” said Jacob Cohen, Co-Founder and CEO of Mangoceuticals.

Mangoceuticals and its partner IntraMont are moving swiftly to bring MGX-0024 to market. The company is scaling production and reaching out to large-scale farms in the US, UK, Canada, and Australia for pilot deployments. Mangoceuticals is also engaging regulatory authorities in these markets to work towards securing approvals for MGX-0024 to be used as a frontline defense against respiratory diseases and zoonotic threats like avian flu. Additional field studies are planned at Duraiswamy Farm and 2–3 other farms in Indian states with a known H5N1 presence to further validate efficacy.

Furthermore, MangoRx IP Holdings, LLC, a wholly-owned subsidiary of the Company, which owns the patent for MGX-0024, is in the process of securing a Commercial and Government Entity (CAGE) code to pursue US federal funding through programs like the United States Department of Agriculture’s Agriculture and Food Research Initiative and The Biomedical Advanced Research and Development Authority, a center within the Administration for Strategic Preparedness and Response located within the U.S. Department of Health and Human Services. These efforts aim to support global rollout and meet the rising demand for antibiotic-free poultry, and are expected to drive revenue through partnerships, sales, and licensing agreements.

“MGX-0024 has been shown in studies to stabilize farm production and we believe this opens doors to new markets by meeting consumer and trade demands for antibiotic-free poultry,” commented Mr. Cohen. “We’re eager to collaborate with farms and health leaders worldwide with the goal of making MGX-0024 a global standard.”

For inquiries, contact info@mangorxipholdings.com or visit www.mangorxipholdings.com.

Study Disclaimer

The information contained in this press release regarding the field study results of MGX-0024 is based on controlled studies commissioned and funded by Mangoceuticals, Inc. and conducted by Solice International at Duraiswamy Farm in Palladam, Tamil Nadu, India. While the Company believes the results are accurate and reliable, they are preliminary and subject to further validation through additional independent studies. To strengthen the data, Mangoceuticals is conducting additional testing with Vipragen Biosciences Private Limited, a renowned Contract Research Organization, in collaboration with an Indian government laboratory. These studies aim to further evaluate MGX-0024’s efficacy, including against avian influenza, otherwise known as bird flu or H5N1. The field studies were conducted under controlled conditions, and results may vary in different environments or with broader application. The presence of H5N1 at the study site has not been officially confirmed by local authorities, and claims of efficacy against specific pathogens, including H5N1, are pending further confirmation from ongoing studies.

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 MangoRx

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 has identified men’s wellness telemedicine services and products as a growing sector and especially related to the area of erectile dysfunction (ED), 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 physician 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” 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, relating to, among other things: statements about the ability of our trials to demonstrate safety and efficacy of our product candidates, and other positive results; the risk that initial drug results are not predictive of future results or will not be able to be replicated in clinical trials or that such drugs selected for clinical development will not be successful; challenges and uncertainties inherent in product research and development, including the uncertainty of clinical success and of obtaining regulatory approvals; the Company’s reliance on third parties to conduct its clinical trials; unexpected adverse side effects or inadequate therapeutic efficacy of drug candidates that could limit approval and/or commercialization, or that could result in recalls or product liability claims; uncertainty of commercial success; the inherent risks in early stage drug development including demonstrating efficacy; development time/cost and the regulatory approval process; uncertainties inherent in research and development, including the ability to meet anticipated clinical endpoints, commencement and/or completion dates for clinical trials, regulatory submission dates, regulatory approval dates and/or launch dates, as well as the possibility of unfavorable new clinical data and further analyses of existing clinical data; risks associated with interim data; including the risk that final results could differ from interim data released; the risk that clinical trial data are subject to differing interpretations and assessments by regulatory authorities; whether regulatory authorities will be satisfied with the design of and results from our clinical studies; the progress of our clinical trials; manufacturing difficulties and delays; competition, including technological advances, new products and patents attained by competitors; challenges to patents; changes in behavior and spending patterns of purchasers of health care and other of our products and services; changes to applicable laws and regulations, including global health care reforms; and trends toward health care cost containment; potential lawsuits, claims and actions; the outcome of certain outstanding legal matters, claims and allegations, the requirement that the Company spend cash and management’s resources on such matters, even if the Company ultimately prevails in such matters, risks associated with certain counterparties to lawsuits having significantly greater resources than us, settlements we may choose to enter into in the future and the terms thereof, and potential regulatory reviews, inquiries or lawsuits, which are brought about by claims made in private lawsuits; 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; the ability of the Company to raise funding, the terms of such funding, and dilution caused thereby; our ability to meet the continued listing requirements of Nasdaq; our ability to maintain the listing of our common stock on Nasdaq; our ability to commercialize our patent portfolio; our ability to obtain Comisión Federal para la Protección contra Riesgos Sanitarios for our ED product in Mexico, the costs thereof and timing associated therewith; our ability to obtain additional funding and generate revenues to support our operations; risks associated with our products which have not been, and will not be, approved by the U.S. Food and Drug Administration (“ FDA ”) and have not had the benefit of the FDA’s clinical trial protocol which seeks to prevent the possibility of serious patient injury and death; risks that the FDA may determine that the compounding of our products does not fall within the exemption from the Federal Food, Drug, and Cosmetic Act (“ FFDCA Act ”) provided by Section 503A; risks associated with related party relationships and agreements; the effect of data security breaches, malicious code and/or hackers; competition and our ability to create a well-known brand name; changes in consumer tastes and preferences; material changes and/or terminations of our relationships with key parties; significant product returns from customers, product liability, recalls and litigation associated with tainted products or products found to cause health issues; claims, lawsuits and litigation relating to our intellectual property, including allegations that our intellectual property infringes on the intellectual property of others, costs related to any such claims or lawsuits and resources required to expend in connection therewith; our ability to innovate, expand our offerings and compete against competitors which may have greater resources; our significant reliance on related party transactions and risks associated with related party relationships and agreements; the projected size of the potential market for our technologies and products; 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 and fraud risks and problems with our websites; changes in, and our compliance with, rules and regulations affecting our operations, sales, marketing and/or our products; shipping, production or manufacturing delays; regulations we are required to comply with in connection with our operations, manufacturing, labeling and shipping; our dependency on third-parties to prescribe and compound our products; our ability to establish or maintain relations and/or relationships with third-parties; potential safety risks associated with our products, including the use of ingredients, combination of such ingredients and the dosages thereof; the effects of changing rates of inflation and interest rates, and economic downturns, including potential recessions, as well as macroeconomic, geopolitical, health and industry trends, pandemics, acts of war (including the ongoing Ukraine/Russian conflict and war in Israel), tariffs, trade wars, and other large-scale crises; our ability to protect intellectual property rights; our ability to attract and retain key personnel to manage our business effectively; overhang which may reduce the value of our common stock; volatility in the trading price of our common stock; and general consumer sentiment and economic conditions that may affect levels of discretionary customer purchases of the Company’s products, including potential recessions and global economic slowdowns. 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 March 31, 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.

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FOR INVESTOR RELATIONS

Mangoceuticals Investor RelationsEmail: investors@mangorx.com