Mangoceuticals Advances H1N1 Efficacy Study Noting Significant Reduction in Viral Load in Phase 1 Studies and Engages Vipragen Biosciences to Structure H5N1 Cohort for Expanded Research

Rhea-AI Summary

Mangoceuticals (NASDAQ: MGRX) has announced significant progress in its H1N1 efficacy study, reporting a substantial reduction in viral load during Phase 1 animal trials. The company is now advancing to the next research stage while simultaneously expanding its focus to include H5N1 (Avian Influenza) studies.

The research, conducted by Vipragen Biosciences in India, utilizes Mangoceuticals' proprietary formulation combining advanced polyphenol and zinc chemistry. The H5N1 cohort will run concurrently with the ongoing H1N1 study, demonstrating the company's commitment to addressing multiple respiratory illness threats.

The company plans to disclose final results after completing the studies and securing proper intellectual property protections through provisional filings.

Positive

• Significant reduction in viral load demonstrated in H1N1 Phase 1 animal trials
• Expansion of research to include H5N1 (Avian Influenza) studies
• Development of proprietary formulation using polyphenol and zinc chemistry

Negative

• None.

Insights

Medical Research Analyst

The advancement of Mangoceuticals' respiratory illness prevention technology marks a significant milestone in the antiviral therapeutics space. The demonstrated reduction in viral load during H1N1 Phase 1 studies is particularly noteworthy, as viral load serves as a critical biomarker for antiviral efficacy. The company's proprietary formulation combining polyphenols and zinc chemistry represents an innovative approach, as these compounds have shown synergistic effects in previous research.

The strategic decision to pursue concurrent H5N1 studies is especially timely, given the growing concerns about pandemic preparedness. H5N1, with its historically high mortality rate of approximately 60%, represents a significant public health threat. The ability to potentially address both H1N1 and H5N1 with a single platform technology could position Mangoceuticals favorably in the $4.5 billion global antiviral market.

The collaboration with Vipragen Biosciences, an AAALAC-accredited facility, provides robust validation for the research methodology. However, investors should note several critical factors:

• The current Phase 1 results, while promising, are from animal studies and human trials will be necessary for regulatory approval
• The concurrent study approach could accelerate development timelines but also increases operational complexity and resource requirements
• The company's intellectual property strategy, including provisional patent filings, will be important for maintaining competitive advantages

This development represents a potential pivot point for Mangoceuticals, expanding beyond its current men's wellness focus into the broader infectious disease market. The successful development of an effective respiratory illness prevention technology could significantly enhance the company's market position and value proposition.

Dallas, Texas, Feb. 06, 2025 (GLOBE NEWSWIRE) -- Mangoceuticals, Inc. (NASDAQ: MGRX) (“Mangoceuticals” or the “Company”), a company focused on developing, marketing, and selling a variety of men’s wellness products and services via a secure telemedicine platform, today announced significant progress in its ongoing H1N1 efficacy study conducted by Vipragen Biosciences (“Vipragen”), an AAALAC-accredited preclinical CRO in Mysuru, India, on its patented respiratory illness prevention technology in collaboration with Intramont Technologies, Inc. (“Intramont”).

Building on strong preliminary results, the Company is advancing to the next stage of research while also engaging Vipragen to structure a cohort for evaluating its patented respiratory illness prevention technology against the H5N1 virus (Avian Influenza). The H5N1 cohort is intended to run concurrently with the ongoing H1N1 study.

This milestone follows promising results from the initial H1N1 animal trial, which demonstrated a significant reduction in viral load. These findings underscore the potential of the technology and provide a strong foundation for continued exploration and expanded applications. The H1N1 and forthcoming H5N1 studies utilize Mangoceuticals’ proprietary formulation of advanced polyphenol and zinc chemistry.

Jacob Cohen, Founder and CEO of Mangoceuticals, commented: “Our ability to progress with this study reflects the robust potential of our innovative platform. The inclusion of H5N1 as part of the next leg of our research allows us to address another pressing global health concern while demonstrating our commitment to groundbreaking solutions for respiratory illnesses.”

Dr. Douglas Christianson, the Company’s Director of Medical Research and Product Innovation, added: “This next phase of advancement for H1N1 and the development of an H5N1 cohort highlight the versatility of our platform technology. These initiatives reaffirm our dedication to addressing evolving viral threats through innovation and cutting-edge research.”

With respiratory infections posing a growing global health concern, Mangoceuticals remains committed to leveraging its patented technology to combat these threats effectively. The company anticipates disclosing the final results of its studies upon completion and after ensuring proper intellectual property protections through provisional filings.

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 or on social media @Mango.Rx.

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: the investigation into, outcome of the investigation regarding, and potential lawsuits, claims and actions regarding, a potential stock manipulation scheme relating to the Company’s common stock following the Company’s recent reverse stock split; 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 fact that our Chairman and Chief Executive Officer, Jacob D. Cohen has significant voting control over the Company; 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 recent and future 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) 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, 2023 and our Quarterly Report on Form 10-Q for the quarter September 30, 2024, 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 Relations

Email: investors@mangorx.com

FAQ

What results did MGRX achieve in its H1N1 Phase 1 animal trials?

MGRX reported significant reduction in viral load during its H1N1 Phase 1 animal trials conducted by Vipragen Biosciences.

How is MGRX expanding its respiratory illness research in 2025?

MGRX is expanding its research to include H5N1 (Avian Influenza) studies, which will run concurrently with the ongoing H1N1 study.

What technology is MGRX using in its respiratory illness studies?

MGRX is using its proprietary formulation that combines advanced polyphenol and zinc chemistry.

When will MGRX release the final results of its H1N1 and H5N1 studies?

MGRX will disclose the final results after completing the studies and securing proper intellectual property protections through provisional filings.

Where is MGRX conducting its respiratory illness prevention studies?

MGRX is conducting its studies at Vipragen Biosciences, an AAALAC-accredited preclinical CRO in Mysuru, India.