8-K
MANGOCEUTICALS, INC. (MGRX)
UNITED
STATES
SECURITIES
AND EXCHANGE COMMISSION
Washington,
D.C. 20549
FORM
8-K
CURRENT
REPORT
Pursuant
to Section 13 or 15(d) of the Securities Exchange Act of 1934
Date of Report (Date of Earliest Event Reported): October 3, 2024
MANGOCEUTICALS,
INC.
(Exactname of registrant as specified in its charter)
| Texas | 001-41615 | 87-3841292 |
|---|---|---|
| (State or other jurisdiction<br><br> <br>of incorporation) | (Commission<br><br> <br>File Number) | (IRS Employer<br><br> <br>Identification No.) |
| 15110 N. Dallas Parkway, Suite 600<br><br> <br>Dallas, Texas | 75248 | |
| --- | --- | |
| (Address of principal executive offices) | (Zip Code) |
Registrant’stelephone number, including area code: (214) 242-9619
Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:
| ☐ | Written<br> communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425) |
|---|---|
| ☐ | Soliciting<br> material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) |
| ☐ | Pre-commencement<br> communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) |
| ☐ | Pre-commencement<br> communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c)) |
Securities registered pursuant to Section 12(b) of the Act:
| Title of each class | Trading Symbol(s) | Name of each exchange on which registered |
|---|---|---|
| Common<br> Stock, $0.0001 Par Value Per Share | MGRX | The<br> Nasdaq Stock Market LLC<br><br> <br>(Nasdaq<br> Capital Market) |
Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).
Emerging growth company ☒
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐
Item8.01. Other Events.
On October 3, 2024, Mangoceuticals, Inc. (the “Company”, “we” and “us”) issued a press release announcing the launch of its oral Tirzepatide weight loss treatment, marketed and branded under the name ‘Trim.’ A copy of the press release is attached hereto as Exhibit 99.1 and is incorporated herein by reference.
Item9.01. Financial Statements and Exhibits
| Exhibit No. | Description of Exhibit |
|---|---|
| 99.1* | Press Release dated October 3, 2024 |
| 104 | Inline<br> XBRL for the cover page of this Current Report on Form 8-K |
* Filed herewith.
Theinclusion of any website address in this Form 8-K, and any exhibit thereto, is intended to be an inactive textual reference only andnot an active hyperlink. The information contained in, or that can be accessed through, such website is not part of or incorporated intothis Form 8-K.
Forward-LookingStatements
This Current Report on Form 8-K, including the press release filed as Exhibit 99.1 to this Current Report on Form 8-K, contains forward-looking statements within the meaning of the federal securities laws, including the Private Securities Litigation Reform Act of 1995, and, as such, may involve known and unknown risks, uncertainties and assumptions. You can identify these forward-looking statements by words such as “may,” “should,” “expect,” “anticipate,” “believe,” “estimate,” “intend,” “plan” and other similar expressions. These forward-looking statements relate to the Company’s current expectations and are subject to the limitations and qualifications set forth in the press release as well as in the Company’s other filings with the Securities and Exchange Commission, including, without limitation, that actual events and/or results may differ materially from those projected in such forward-looking statements. These statements also involve known and unknown risks, which may cause the results of the Company, its divisions and concepts to be materially different than those expressed or implied in such statements, including those referenced in the press release. Accordingly, readers should not place undue reliance on any forward-looking statements. Forward-looking statements may include comments as to the Company’s beliefs and expectations as to future financial performance, events and trends affecting its business and are necessarily subject to uncertainties, many of which are outside the Company’s control. More information on potential factors that could affect the Company’s financial results is included from time to time in the “Cautionary Statement Regarding Forward-Looking Statements,” “Risk Factors” and “Management’s Discussion and Analysis of Financial Condition and Results of Operations” sections of the Company’s most recently filed periodic reports on Form 10-K and Form 10-Q and subsequent filings with the SEC and available at www.sec.gov and in the “SEC Filings” section of the Company’s website at www.mangoceuticals.com. Forward-looking statements speak only as of the date they are made. The Company undertakes no obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events or otherwise that occur after that date, except as otherwise provided by law.
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
| MANGOCEUTICALS, INC. | ||
|---|---|---|
| Date:<br> October 3, 2024 | By: | /s/ Jacob D. Cohen |
| Jacob<br> D. Cohen | ||
| Chief<br> Executive Officer |
Exhibit99.1
MangoRxIntroduces Oral Tirzepatide GLP-1 Receptor Agonist for Advanced Weight Loss Solutions
Dallas, Texas / October 3, 2024 —Mangoceuticals, Inc. (NASDAQ: MGRX) (“MangoRx” or the “Company”), a company focused on developing, marketing, and selling men’s health and wellness products via a secure telemedicine platform, announces the release of its latest innovation, “TRIM,” a compounded, oral dissolvable Tirzepatide tablet. Available for purchase at $399 per month, this new product offers patients an advanced and convenient alternative to injectable therapies.
Tirzepatide, a dual GIP and GLP-1 receptor agonist, has gained widespread recognition for its effectiveness in promoting substantial weight loss by enhancing metabolic functions and controlling appetite. Clinical trials have shown that Tirzepatide can deliver weight reductions of up to 20% in obese individuals. The phase 3 SURMOUNT-1 clinical trial showed that a significant percentage of participants achieved weight loss of over 15-20% in just 72 weeks, marking it as a viable option and alternative for effective, long-term weight management.
Further, in the SURMOUNT-4 trial, Tirzepatide not only helped patients achieve substantial weight loss, but it also helped patients maintain their progress over an extended period. After 88 weeks of treatment, patients experienced a total weight reduction of up to 25%, with nearly 90% maintaining at least 80% of their initial weight loss.
MangoRx’s TRIM formulation now provides Tirzepatide treatment in an easy-to-use oral dissolvable tablet, eliminating the need for injections and enhancing patient convenience.
The launch of TRIM is a key strategic move for MangoRx, as the Company looks to strengthen its foothold in the expanding weight management sector. As demand for non-invasive, clinically proven solutions rises, we believe MangoRx is positioned to capitalize on this market growth.
Jacob Cohen, CEO and Founder of MangoRx, stated, “We are excited to bring TRIM to market, offering consumers a cutting-edge, oral alternative to conventional weight loss injections. TRIM’s introduction marks another significant step for MangoRx as we continue to innovate and meet the changing needs of patients. By launching TRIM, we are delivering a solution that enhances patient convenience without sacrificing efficacy. As demand for GLP-1-based treatments continues to climb, our telemedicine platform ensures that patients have access to safe, reliable options.”
According to a study performed by Roots Analysis, the global GLP-1 market is projected to grow from $49.3 billion in 2024 to $157.5 billion by 2035, with the obesity segment expected to capture the majority share by 2035, due to rising obesity rates and demand for effective treatments.
With the addition of TRIM, MangoRx now offers patients both Tirzepatide and Semaglutide options for weight loss treatments. Following the successful release of our Semaglutide-based oral dissolvable tablet branded as SLIM, patients can choose from two advanced, highly effective GLP-1 receptor agonists, each tailored to meet different needs in their weight management journey. Both products are currently listed on the MangoRx website and available with a doctor’s prescription, providing expanded access to cutting-edge weight loss solutions through its telemedicine platform.
AboutMangoRx
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.
CautionaryNote Regarding Forward-Looking Statements
Certainstatements made in this press release contain forward-looking information within the meaning of applicable securities laws, includingwithin the meaning of the Private Securities Litigation Reform Act of 1995 (“forward-looking statements”). These forward-lookingstatements represent the Company’s current expectations or beliefs concerning future events and can generally be identified usingstatements 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 areoutside of the Company’s control which could cause actual results to differ materially from the results expressed or implied inthe forward-looking statements, including: the market for, demand for, and efficacy of Tirzepatide and Semaglutide options for weightloss treatments; our ability to meet Nasdaq’s minimum bid price requirement and other continued listing requirements of Nasdaq,including the fact that the Company does not currently comply with Nasdaq’s minimum bid price requirement; our ability to maintainthe listing of our common stock on Nasdaq; our ability to commercialize our patent portfolio; our ability to obtain Comisión Federalpara 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 havenot been, and will not be, approved by the U.S. Food and Drug Administration (“FDA”) and have not had the benefitof the FDA’s clinical trial protocol which seeks to prevent the possibility of serious patient injury and death; risks that theFDA 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 effectof data security breaches, malicious code and/or hackers; competition and our ability to create a well-known brand name; changes in consumertastes and preferences; material changes and/or terminations of our relationships with key parties; significant product returns fromcustomers, product liability, recalls and litigation associated with tainted products or products found to cause health issues; our abilityto innovate, expand our offerings and compete against competitors which may have greater resources; our significant reliance on relatedparty transactions and risks associated with related party relationships and agreements; the projected size of the potential market forour technologies and products; risks related to the fact that our Chairman and Chief Executive Officer, Jacob D. Cohen has significantvoting control over the Company; risks related to the significant number of shares in the public float, our share volume, the effectof sales of a significant number of shares in the marketplace; dilution caused by recent offerings; conversion of outstanding sharesof preferred stock and the rights and preferences thereof, the fact that we have a significant number of outstanding warrants to purchaseshares of common stock and other convertible securities, the resale of which underlying shares have been registered under the SecuritiesAct of 1933, as amended, dilution caused by exercises/conversions thereof, overhang related thereto, and decreases in the trading priceof our common stock caused by sales thereof; our ability to build and maintain our brands; cybersecurity, information systems and fraudrisks and problems with our websites; changes in, and our compliance with, rules and regulations affecting our operations, sales, marketingand/or our products; shipping, production or manufacturing delays; regulations we are required to comply with in connection with ouroperations, manufacturing, labeling and shipping; our dependency on third-parties to prescribe and compound our products; our abilityto establish or maintain relations and/or relationships with third-parties; potential safety risks associated with our products, includingthe use of ingredients, combination of such ingredients and the dosages thereof; the effects of changing rates of inflation and interestrates, 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 intellectualproperty rights; our ability to attract and retain key personnel to manage our business effectively; overhang which may reduce the valueof our common stock; volatility in the trading price of our common stock; and general consumer sentiment and economic conditions thatmay affect levels of discretionary customer purchases of the Company’s products, including potential recessions and global economicslowdowns. Although we believe that our plans, intentions and expectations reflected in or suggested by the forward-looking statementswe 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.
Moreinformation on potential factors that could affect the Company’s financial results is included from time to time in the “CautionaryNote Regarding Forward-Looking Statements,” “Risk Factors” and “Management’s Discussion and Analysis ofFinancial Condition and Results of Operations” sections of the Company’s filings with the SEC, including the Company’sAnnual Report on Form 10-K for the year ended December 31, 2023 and our Quarterly Report on Form 10-Q for the three and six months endedJune 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 Companyare expressly qualified in their entirety by the cautionary statements referenced above. Other unknown or unpredictable factors alsocould have material adverse effects on the Company’s future results. The forward-looking statements included in this press releaseare 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 thesestatements after the date of this release, except as required by law, and takes no obligation to update or correct information preparedby third parties that are not paid for by the Company. If we update one or more forward-looking statements, no inference should be drawnthat we will make additional updates with respect to those or other forward-looking statements.*
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FORINVESTOR RELATIONS
Mangoceuticals Investor Relations
Email: investors@mangorx.com