• The Dallas Based, Direct-to-Consumer Telemedicine Company Brings the FDA-Approved Oral Testosterone Replacement Therapy Treatment to the Telehealth Market

Dallas, Texas, March 12, 2024 (GLOBE NEWSWIRE) -- Mangoceuticals, Inc. (NASDAQ: MGRX) (“MangoRx” or the “Company”), a company focused on developing, marketing, and selling a variety of men’s health and wellness products via a secure telemedicine platform, including its uniquely formulated hair growth product (‘GROW’) and erectile dysfunction (ED) drug (‘Mango’), is excited to announce the highly anticipated release and availability of ‘PRIME’ by MangoRx, Powered by Kyzatrex^®️ (“PRIME”) bringing the FDA-approved oral testosterone replacement therapy (TRT) treatment to consumers across the U.S via its proprietary telehealth platform.

MangoRx intends to market PRIME to those male individuals who are both a) currently on some alternative form of TRT treatment, such as topicals and other invasive injectables or pellets, and b) those experiencing common symptoms associated with low testosterone (Low-T) and seeking an immediate TRT treatment. Those interested in speaking with a medical provider to obtain a prescription for PRIME can do so by visiting MangoRx’s website at https://www.mangorx.com/app/prime.

According to a study published in the National Library of Medicine which examined prescribing patterns in the United States, approximately 2.9% of men aged greater than 40 years old and 3.75% of men aged greater than 60 years old have been prescribed with some form of TRT. With the US population of men at approximately 166.7 million, this places the current market at roughly 5,000,000 men that are on some form of TRT therapy.

Furthermore, the introduction of oral testosterone therapy presents a compelling opportunity to tap into a significant addressable market. By offering an alternative to injectable TRT, oral therapy addresses the concerns of individuals who are hesitant or unwilling to undergo injections. This segment of the market, encompassing those with needle aversion, represents a substantial portion of the population and presents a compelling case for the viability and potential growth of oral testosterone therapy.

Jacob Cohen, MangoRx’s Co-Founder and CEO, noted, “We firmly believe that between the convenience and non-invasive factor of taking PRIME orally and the reduced side effects that come with it as opposed to traditional injectable TRT, MangoRx is very well positioned to grab a significant piece of the current market share for men experiencing Low-T. As we believe PRIME’s oral delivery TRT treatment is a true game-changer, MangoRx will be seeking to engage popular social media influencers as well as high-profile celebrities and athletes to assist us as we launch PRIME into the marketplace.”

PRIME represents a critical expansion into a new vertical with massive market potential and very little competition on the consumer side, while remaining completely consistent with MangoRx’s established identity as a company committed to providing new and innovative pharmaceutical based solutions helping men achieve optimal performance in all areas of life. With the Company’s established marketing and telemedicine infrastructure in place, MangoRx is hitting the ground running to take PRIME to patients in need across the country. All orders will be reviewed and, pending approval, fulfilled, then discreetly shipped via MangoRx’s URAC accredited mail order partner pharmacy directly to the patient’s doorstep.

About PRIME

‘PRIME’, by MangoRx, powered by Kyzatrex^®️, an innovative FDA-approved oral Testosterone Replacement Therapy (TRT) product, is a prescription drug that is used to treat adult men who have low or no testosterone levels due to certain medical conditions and is one of only three FDA approved TRT treatments that is delivered orally--as opposed to the traditional, invasive, and inconvenient injection-based drug delivery protocol. ‘PRIME’, by MangoRx, powered by Kyzatrex^®️ delivers testosterone in a softgel capsule that is absorbed primarily via the lymphatic system, avoiding liver toxicity.

The benefits of ‘PRIME,’ powered by Kyzatrex^®️, over traditional injectable TRTs include enhanced vitality, improved mood, sharper cognition, optimized physical performance, and balanced hormonal levels at 96% efficacy by day 90, as demonstrated in Phase 3 clinical research by Marius Pharmaceuticals. With ‘PRIME,’ MangoRx will expand broad-based consumer access to this revolutionary therapy. PRIME is available to MangoRx customers at a price of $249/month with eligibility to receive an additional 10% discount per month if subscribed to another MangoRx product (e.g. ‘Mango’ for erectile function or ‘Grow’ for hair growth).

To learn more about PRIME, please visit https://www.mangorx.com/app/prime for more information.

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, including, but not limited to; 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 and President, Jonathan Arango, combined have majority 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; the fact that we have a significant number of outstanding warrants to purchase shares of common stock at $1.00 per share, the resale of which underlying shares have been registered under the Securities Act of 1933, as amended; 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 Mango ED product, including the use of ingredients, combination of such ingredients and the dosages thereof; the effects of high inflation, increasing 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 other large-scale crises; our ability to protect intellectual property rights; our ability to attract and retain key personnel to manage our business effectively; our ability to maintain the listing of our common stock on the Nasdaq Capital Market; 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 Quarterly Report on Form 10-Q for the Quarter ended September 30, 2023. 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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