MANGOCEUTICALS, INC.

Reference is made to Part I, Item 1A, “Risk Factors” included in our 2024 Annual Report for information concerning risk factors, which should be read in conjunction with the factors set forth in “Cautionary Statement Regarding Forward-Looking Information” of this Report and below. There have been no material changes with respect to the risk factors disclosed in our 2024 Annual Form 10-K, except as set forth below. You should carefully consider such factors in the 2024 Annual Report and below, which could materially affect our business, financial condition or future results. The risks described in the 2024 Annual Report and below, are not the only risks facing our company. Additional risks and uncertainties not currently known to us or that we currently deem to be immaterial also may materially and adversely affect our business, financial condition and/or operating results.

We face risks in connection with the current governmental shutdown.

The Company’s operations, clinical trials, and commercialization efforts are subject to extensive regulation by U.S. federal and state agencies, including the U.S. Food and Drug Administration (“FDA”). Any continued interruption in government operations as a result of the current government shutdown, or otherwise, could adversely affect the Company in a number of ways. For example, a government shutdown could delay or suspend the review, approval, or inspection of our pharmaceutical and compounded products, including our ongoing or planned clinical trials for our patented respiratory illness prevention technology. Delays in FDA review or inspection could also prevent the timely commercialization of our Pharmaceutical Products or our compounded products, and could materially impact anticipated revenues.

Additionally, a government shutdown may delay or interrupt the issuance of regulatory guidance, approvals for advertising claims, or inspections of manufacturing facilities, which could result in delayed product launches, halted production, or increased compliance costs.

The Company is also subject to other risks associated with government actions, including changes in healthcare, telemedicine, and pharmaceutical regulations. Such changes could affect our ability to market, sell, or distribute our products online or across state lines. Further, any interruption in federal funding or administrative operations may impact public health initiatives, clinical trial oversight, and the availability of key resources or approvals necessary for the Company to continue operations in a timely manner. Consequently, a government shutdown or prolonged regulatory delays could materially and adversely affect our business, financial condition, results of operations, and prospects.

Separately, the Company may, from time to time, seek to raise additional capital through public offerings of its securities or file registration statements with the SEC in connection with such offerings. Any closure of the SEC, whether due to a government shutdown (such as is currently ongoing), operational disruption, or other events, could delay the review and effectiveness of such registration statements. As a result, the Company may be unable to offer or sell securities in the public markets when needed, which could limit our ability to raise capital to fund operations, clinical trials, commercialization efforts, or other strategic initiatives. Delays in SEC review or effectiveness of registration statements could also increase costs, create uncertainty in our financing plans, and negatively affect investor confidence, potentially adversely impacting the Company’s financial condition, liquidity, and ability to execute its business strategy.