MGRX Mangoceuticals Inc

Mangoceuticals, Inc. (NASDAQ: MGRX) (“MangoRx” or the “Company”), a leader in men’s health and wellness products including erectile dysfunction (ED), hair growth, weight loss, and hormone replacement therapies, is excited to announce the initiation of efficacy studies on its patented respiratory illness prevention technology in collaboration with Vipragen Biosciences and IntraMont Technologies, Inc. Notably, these trials have been pre-funded, ensuring that the Company does not need to raise any additional capital for the completion of these studies, which are anticipated to be concluded in the earlier part of the 3rd quarter.

The recently acquired patented technology by MangoRx is designed to reduce the incidence of respiratory illnesses, including, but not limited to, H1N1 variants, Avian Flu, the common cold, Coronavirus and others. The studies are set to commence within the next few weeks with results anticipated to be concluded in the earlier part of the 3rd quarter. These include animal studies to quantify the prophylactic performance of the technology against select viruses and viral strains. The composition being tested contains a very select tannin (an enhanced polyphenol) and zinc gluconate as its primary active ingredients.

Jacob Cohen, Co-Founder and CEO of MangoRx stated, "Our global patent portfolio enables us to make a meaningful impact on global health. The initiation of these studies is a crucial step in demonstrating the efficacy of our innovative technology. We anticipate that our solution will play a vital role in managing respiratory illness outbreaks."

The studies will be conducted by Vipragen Biosciences, an AAALAC-accredited preclinical CRO located in Mysuru, India, in collaboration with IntraMont Technologies, Inc. The specific studies include an efficacy study of an anti-viral oral spray in treating influenza infection in mice. This study will evaluate the therapeutic potential and effectiveness of the anti-viral oral spray in combating influenza infections in a controlled mouse model, aiming to provide critical data on the spray's ability to reduce viral load, alleviate symptoms, and improve survival rates in treated subjects. Additionally, the evaluation of antiviral efficacy will be conducted using the ASTM E1052 standard test method assay, which rigorously assesses the antiviral efficacy of the technology, measuring the ability of the antiviral agents to inactivate specific viruses and providing essential insights into their potential for broader antiviral applications.

James Intrator, CEO of Intramont Technologies, Inc. and one of the original inventors of the intellectual property and technology commented, “the primary focus will be on testing the durability of the prophylactic coating towards viral infections. Polyphenolic nasal sprays have been successfully used to block select respiratory viruses, and the company is enhancing this approach by transitioning the concept of nasal spray to an oral-only application for better distribution and user compliance. The technology features biosafe ingredients that readily bind to protein spikes on the surface of virions (virus particles). Additionally, polyphenols bind to the oral and oropharyngeal membranes, acting as a tissue barrier.”

Previous research has highlighted the potential of this technology. In studies conducted by Moscow State University in late 2020 and early 2021, researchers used cell cultures with a pseudo virus simulant of SARS-CoV-2, combining a specific commercial tannin with zinc gluconate. The results demonstrated a significant reduction in active virus, showing a 93% (±5%) decrease compared to the control group (Tsvetkov et al., 2021).

Before someone can develop certain respiratory infections, the virus must first infect the mouth or back of the throat (surface of the pharynx) and incubate. Various research groups, including Columbia University (de Vries et al., 2021), Cornell (Shapira et al., 2022), and Berkeley (Zhu et al., 2022), have demonstrated success in preventing respiratory infections through the application of daily-use nasal sprays. These sprays have shown effectiveness even up to 12 hours after initial exposure to the virus. In some published results, the principal active ingredient of the nasal spray was a polyphenol.

Importantly, zinc in nasal applications can cause anosmia due to Zn+2 damage to the olfactory epithelium nerves (Alexander & Davidson, 2006). This can cause some people to lose their sense of smell, in some cases permanently. This led the FDA to prohibit the use of zinc salts directly in the nasal passages. However, there are no reported problems from zinc in oral applications, such as lozenges, mouthwashes, or toothpastes, where zinc salts retain a distinct presence even after repeated rinsing (Gilbert et al., 1989). This makes the oral application of this technology particularly safe and effective. The technology uses zinc gluconate in its formulation to ensure safety and efficacy in preventing respiratory infections.

MangoRx’s patent portfolio for this innovative technology is globally recognized, enabling the company to address respiratory health concerns worldwide. The Company anticipates that the product will initially be available as a lozenge or a toothpaste providing a convenient and effective means of preventing the onset and spread of respiratory illnesses. The global influenza market alone was valued at $8.28 billion in 2023, highlighting the significant potential for this technology in addressing respiratory health (Market Data Forecast, 2023).

Should the current trials yield positive results, MangoRx will promptly initiate a subsequent study specific to the H5N1 strain. This study will aim to evaluate the technology's potential in addressing avian influenza, a pressing concern for poultry farms across the US. This follow-up study is particularly relevant given the recent rise in avian flu outbreaks, emphasizing the potential broader applications of this innovative prophylactic technology.

With respiratory infections posing an increasing threat, MangoRx is actively exploring the potential of its patented technology to mitigate the impact of this global health concern.

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 and hormone replacement therapies. 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, our ability to meet Nasdaq’s minimum bid price requirement and other continued listing requirements of Nasdaq; the Company’s stockholders’ equity as of the Company’s next fiscal quarter end, which is required to be above $2.5 million pursuant to correspondence from 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 ED product 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 planned 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; our ability to innovate, expand our offerings and compete against competitors which may have greater resources; our significant reliance on related party transactions; 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, and the fact that the majority of our shareholders paid less for their shares than the public offering price of our common stock in our recent initial public offering; dilution caused by recent 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 brand; 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 ED product; 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 three months ended March 31, 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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