MANGOCEUTICALS TO INTRODUCE “PRIME”, POWERED BY KYZATREX®️ (CIII TESTOSTERONE UNDECANOATE CAPSULES), FOR AN FDA APPROVED ORAL TESTOSTERONE REPLACEMENT THERAPY (TRT) PRODUCT

Rhea-AI Summary

Mangoceuticals, Inc. (NASDAQ: MGRX) announces a marketing agreement with Marius Pharmaceuticals to launch KYZATREX, an FDA-approved oral Testosterone Replacement Therapy, under the program PRIME by MangoRx. KYZATREX is expected to be available on MangoRx's telemedicine platform starting January 31, 2024. The new therapy aims to address testosterone deficiency in men, with a focus on providing a convenient and effective treatment option.

The Dallas Based, Direct-to-Consumer Telemedicine Company Secures Marketing Agreement with Marius Pharmaceuticals Bringing KYZATREX to the Telehealth Market as ‘Prime’ by MangoRx

Dallas, Texas & Raleigh, NC, Dec. 13, 2023 (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 that it has entered into a Marketing Agreement with Marius Pharmaceuticals ("Marius") to market and sell KYZATREX^®️, an innovative FDA-approved oral Testosterone Replacement Therapy (TRT) product, under the program, 'PRIME' by MangoRx.

PRIME will be available on MangoRx’s telemedicine platform with an anticipated launch date of January 31, 2024.

KYZATREX, a prescription drug that is used to treat adult men who have low or no testosterone levels due to certain medical conditions, 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. KYZATREX delivers testosterone in a softgel capsule that is absorbed primarily via the lymphatic system, avoiding liver toxicity.

Testosterone deficiency is often first recognized through symptoms of fatigue or low energy, decreased sex drive, lower muscle mass and many other negative downstream impacts. PRIME, powered by KYZATREX, can help men restore Testosterone to normal levels and improve how they feel. In a 6-month open-label clinical study of 139 hypogonadal patients, 88% of patients taking KYZATREX had normal testosterone levels at Day 90 (worst case scenario (WCS) efficacy calculation, excluding Site 104).¹ Among study completers (n=127), 96% of KYZATREX patients achieved normal testosterone levels at Day 90.² With PRIME, MangoRx will expand broad-based consumer access to this innovative therapy.

TRT treatments have traditionally been delivered through intramuscular needle injection, a subcutaneous implant, or a topical gel. These applications have suffered from different drawbacks depending on the delivery method, such as painful administration, uneven absorption, risk of transfer to others, and disruptions to the body's natural diurnal rhythm allowing for peak performance early in the day.

Twice daily oral TRTs offer painless administration, promote steady absorption, lower SHGB levels, increase free T levels to give the body more usable testosterone, and work with the body's natural diurnal rhythm. Oral softgels are also convenient, mess-free, and discreet.

Shalin Shah, CEO of Marius, shared, “This expansion into telehealth marks an important step in the care of Testosterone Deficient patients. Testosterone Deficiency is a serious chronic disease and has been inadequately addressed by previous generations of products. KYZATREX marks a shift in the treatment paradigm and a meaningful opportunity for patients seeking to restore optimal testosterone levels. Marius is excited to partner with MangoRx as an innovative partner in the DTC marketplace. We look forward to the Mango team bringing more awareness around the significance of Testosterone as a metabolic hormone and its role in optimal health for men with Low T.”

PRIME by MangoRx will bring KYZATREX to patients spanning 48 states through the Company’s telemedicine platform, which is optimized to deliver a smooth medical prescription process, including blood work and synchronous telehealth visits with a fully licensed prescribing physician. 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.

Jacob Cohen, MangoRx’s Co-Founder and CEO, noted, “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 our established identity as a company committed to providing new and innovative pharmaceutical based solutions helping men achieve optimal performance in all areas of life. We are extremely fortunate to be working with Marius and to be one of only a few companies with access to this innovative product. With our established marketing and telemedicine infrastructure in place, we are ready to hit the ground running and take PRIME to patients in need across the country next month."

Testosterone deficiency affects approximately four in ten men older than 45 years and 30-50% of men with obesity or type 2 diabetes, according to the Endocrine Society.^3,4 Between 10% and 40% of men worldwide suffer from low testosterone levels.⁵

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) and hair growth. 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.

About Marius Pharmaceuticals

Marius Pharmaceuticals strives to better the lives of patients by focusing on therapies designed for hypogonadism or Testosterone Deficiency. The company's vision is to holistically improve metabolic health and mitigate significant unnecessary costs to the global healthcare system. For more information, please visit www.mariuspharma.com.

About KYZATREX^® (testosterone undecanoate)

KYZATREX is a proprietary softgel oral formulation absorbed primarily via the lymphatic system (meaning it is not toxic to the liver) and indicated in adult males for conditions associated with a deficiency or absence of endogenous testosterone. The safety and efficacy of KYZATREX was demonstrated in a phase 3, multi-center, open-label, six-month study in 155 hypogonadal males between 18 and 65 years of age with documented hypogonadism, as defined by a below normal serum testosterone level (≤281 ng/dL) and at least one sign or symptom of testosterone deficiency. In the efficacy population (n=139), 88 percent of hypogonadal men treated with KYZATREX achieved a mean plasma total testosterone concentration (Cavg) over 24 hours within the normal range (222-800 ng/dL) on the final pharmacokinetic (PK) visit of the study at Day 90 (primary endpoint). Based on exploratory endpoints, patients who received KYZATREX reported improvements in symptoms of low testosterone, including quality of life, energy/fatigue, erectile function, sexual intercourse, and mood. The most common side effect reported in ≥2 percent of KYZATREX patients was increased blood pressure (2.6%). The safety and efficacy of KYZATREX in males less than 18 years old have not been established.

Please see additional Important Safety Information for KYZATREX below, including Boxed Warning for potential increased blood pressure, or visit www.kyzatrex.com.

Important Safety Information for KYZATREX^® (testosterone undecanoate capsules)

Use
KYZATREX^® (testosterone undecanoate) is a prescription drug that is used to treat adult men who have low or no testosterone levels due to certain medical conditions.

KYZATREX is a controlled substance (CIII) because it contains testosterone. It is not known if KYZATREX is safe or effective in males younger than 18 years old. Improper use may affect bone growth in children. KYZATREX is not meant for use by women.

Important Safety Information for KYZATREX^®

KYZATREX can increase blood pressure, which can increase the risk of having a heart attack or stroke and can increase risk of death due to a heart attack or stroke. Your risk may be greater if you have already had a heart attack or stroke or if you have other risk factors for heart attack or stroke.

• If your blood pressure increases while on KYZATREX, blood pressure medicines may need to be started. If you are currently taking blood pressure medicines, they may need to be changed or new blood pressure medicines may need to be added to control your blood pressure.
• If your blood pressure cannot be controlled, KYZATREX may need to be stopped.
• Your healthcare provider will monitor your blood pressure while you are being treated with KYZATREX.
  

Do not take KYZATREX if you: have breast cancer; have or might have prostate cancer; are a woman who is pregnant (KYZATREX may harm your unborn baby); are allergic to KYZATREX or any of its ingredients; or have low testosterone without certain medical conditions (e.g., do not take KYZATREX if you have low testosterone due to age).

Before you take KYZATREX, tell your healthcare provider about all of your medical conditions, including if you: have high blood pressure or are treated for high blood pressure; have a history of diabetes; have heart problems; have high red blood cell count (hematocrit) or high hemoglobin laboratory value; have urinary problems due to an enlarged prostate; have liver or kidney problems; or have problems breathing while you sleep (sleep apnea).

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Taking KYZATREX with certain other medicines can affect each other. Especially, tell your healthcare provider if you take: insulin; medicines that decrease blood clotting (blood thinners); corticosteroids; or medicines that increase blood pressure, such as some cold medicine and pain medicines.

KYZATREX may cause other serious side effects including:

• Increase in red blood cell count (hematocrit) or hemoglobin, which can increase the risk of blood clots, strokes, and heart attacks. You may need to stop KYZATREX if your red blood cell count increases.
• If you already have an enlarged prostate, your signs and symptoms may worsen while taking KYZATREX. These may include: increased urination at night; trouble starting your urine stream; urinating many times during the day; urge to go to the bathroom right away; a urine accident; inability to pass urine or weak urine flow.
• Increased risk of prostate cancer.
• Blood clots in the legs or lungs. Signs and symptoms of a blood clot in your leg can include pain, swelling or redness. Signs and symptoms of a blood clot in your lungs can include difficulty breathing or chest pain.
• Abuse. Testosterone can be abused when taken at higher than prescribed doses and when used with other anabolic androgenic steroids. Abuse can cause serious heart and psychological side effects.
• In large doses, KYZATREX may lower your sperm count.
• Liver problems. Symptoms of liver problems may include: nausea or vomiting; yellowing of your skin or whites of your eyes; dark urine; pain on the right side of your stomach area (abdominal pain).
• Swelling of your ankles, feet, or body (edema), with or without heart failure.
• Enlarged or painful breasts.
• Breathing problems while you sleep (sleep apnea).

Call your healthcare provider right away if you have any of the serious side effects listed above.

The most common side effect of KYZATREX is high blood pressure. Other side effects may include: headache, joint or back pain, diarrhea, increased red blood cell count, anxiety, constipation, swelling of the legs, and increased prostate specific antigen (PSA) levels.

These are not all the possible side effects of KYZATREX. For more information, ask your healthcare provider or pharmacist.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088. You may also report side effects to Marius by visiting www.mariuspharma.com.

Keep KYZATREX and all medicines out of the reach of children.

See Full Prescribing Information and Medication Guide for KYZATREX.

References:

1. KYZATREX [prescribing information]. Raleigh, NC: Marius Pharmaceuticals.
2. Data on File. Raleigh, NC: Marius Pharmaceuticals, 2020.
3. Mulligan T, Frick MF, Zuraw QC, et al. Prevalence of hypogonadism in males aged at least 45 years: the HIM study. Int J Clin Pract. 2006 Jul 1; 60(7): 762–769. doi: 10.1111/j.1742-1241.2006.00992.x
4. “Hypogonadism in Men.” Endocrine Society, Endocrine Society, 31 Mar. 2022, www.endocrine.org/patient-engagement/endocrine-library/hypogonadism.
5. Anaissie, James et al. “Testosterone deficiency in adults and corresponding treatment patterns across the globe.” Translational andrology and urology vol. 6,2 (2017): 183-191. doi:10.21037/tau.2016.11.16
   

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.

Follow Mangoceuticals and MangoRx on social media:
https://www.instagram.com/mango.rx
https://twitter.com/Mangoceuticals
https://www.facebook.com/MangoRxOfficial

FOR PUBLIC RELATIONS
Lucky Break Public Relations
Sahra Simpson
Sahra@luckybreakpr.com
(323) 602-0091 ext. 704

FOR INVESTOR RELATIONS
Mangoceuticals Investor Relations
Email: investors@mangorx.com

MEDIA CONTACT
PHOENIX MGMT Marketing & Consulting
info@phoenix-mediamarketing.com

SOURCE: Mangoceuticals Inc.

FAQ

What is the marketing agreement between Mangoceuticals, Inc. and Marius Pharmaceuticals?

The marketing agreement aims to launch KYZATREX, an FDA-approved oral Testosterone Replacement Therapy, under the program PRIME by MangoRx.

When will KYZATREX be available on MangoRx's telemedicine platform?

KYZATREX is expected to be available on MangoRx's telemedicine platform starting January 31, 2024.

What is the purpose of KYZATREX?

KYZATREX aims to address testosterone deficiency in men, providing a convenient and effective treatment option.

How does KYZATREX differ from traditional TRT treatments?

KYZATREX offers a twice-daily oral softgel delivery, providing painless administration, steady absorption, and convenience.

What are the benefits of PRIME by MangoRx?

PRIME aims to expand consumer access to innovative TRT treatments, providing smooth medical prescription processes and discreet shipping.

What is the significance of Testosterone Deficiency?

Testosterone deficiency affects approximately four in ten men older than 45 years and 30-50% of men with obesity or type 2 diabetes, according to the Endocrine Society.

What is the market potential for PRIME by MangoRx?

PRIME represents a critical expansion into a new vertical with massive market potential and very little competition on the consumer side.

What is MangoRx's approach to providing new and innovative pharmaceutical-based solutions?

MangoRx is committed to providing new and innovative pharmaceutical-based solutions, helping men achieve optimal performance in all areas of life.

What percentage of men worldwide suffer from low testosterone levels?

Between 10% and 40% of men worldwide suffer from low testosterone levels.