S-1: Mangoceuticals Files S-1 for Resale of 4.46 Million Shares Amidst Mounting Losses and Regulatory Scrutiny

Mangoceuticals, Inc. has filed an S-1 registration statement to allow existing shareholders to resell up to 4,461,718 shares of common stock, while the company continues to report significant net losses and faces a lawsuit from Eli Lilly and Company.

Summary

• Mangoceuticals, Inc. has filed an S-1 registration statement to register 4,461,718 shares of common stock for resale by existing selling stockholders, including shares from warrant exercises, preferred stock conversions, and already issued shares.
• The company will not receive any proceeds from the sale of shares by selling stockholders, but will receive proceeds from the exercise of common stock purchase warrants, which will be used for general working capital.
• Mangoceuticals reported a net loss of $8,707,226 for the year ended December 31, 2024, and an accumulated deficit of $20,806,595 as of the same date, with a net loss of $4,839,489 for the three months ended March 31, 2025.
• Revenues decreased to $615,873 for the year ended December 31, 2024, from $731,493 in 2023, primarily due to issues with the transition and migration to a new telehealth platform.
• The company's independent registered public accounting firm included an explanatory paragraph in its report regarding Mangoceuticals' ability to continue as a going concern.
• Mangoceuticals operates a telemedicine platform connecting consumers to healthcare professionals for men's wellness products, including compounded products (Mango ED, Mango GROW, Mojo, Slim) and an FDA-approved oral testosterone replacement therapy (Prime powered by Kyzatrex).
• The compounded products are not FDA-approved and are sold under a Section 503A exemption of the FFDCA Act, which carries risks of regulatory challenge and potential serious side effects.
• The company is currently engaged in a lawsuit with Eli Lilly and Company, filed October 31, 2024, alleging false and misleading advertising for its TRIM product, seeking injunctions and monetary damages.
• Mangoceuticals is significantly reliant on related party transactions, particularly with Epiq Scripts, LLC, a compounding pharmacy 52% owned by CEO Jacob D. Cohen, for product fulfillment and distribution.
• A strategic alternatives review process was initiated in October 2024 by the Board of Directors to unlock and maximize shareholder value, with no definitive timeline or outcome yet.
• The company's CEO, Jacob D. Cohen, holds significant voting control over the company and will exercise majority voting control over Mango & Peaches Corp., a newly formed wholly-owned subsidiary holding substantially all of the company's assets and operations, following shareholder approval.

Sentiment

Score: 2

Explanation: The sentiment is overwhelmingly negative due to significant and increasing net losses, a going concern warning, declining revenues, heavy reliance on related party transactions, and substantial litigation risk from Eli Lilly. While there are market growth projections for the industry, the company's current financial performance and operational challenges overshadow any positives. The need for continuous capital raises and the dilutive nature of existing securities further contribute to the negative outlook.

Positives

• Mangoceuticals offers a diversified portfolio of men's wellness products including ED, hair loss, hormone balance, and weight management, leveraging a telemedicine platform for broad consumer access.
• The company's compounded products utilize a sublingual (under-the-tongue) rapid dissolve tablet (RDT) delivery system, which is believed to offer faster absorption and convenience compared to traditional oral or injectable forms.
• The U.S. market for erectile dysfunction drugs is projected to increase at a 7.4% compound annual growth rate through 2030, reaching approximately $1.1 billion as of 2021.
• The hair loss prevention products market size was valued at $23.6 billion in 2021 and is projected to reach $31.5 billion by 2028, growing at a CAGR of 4.2%.
• The global male hypogonadism market size was $3.1 billion in 2020 and is projected to reach $5.1 billion by 2030, growing at a CAGR of 5.1%.
• The Semaglutide market size grew rapidly from $20.54 billion in 2023 to $23.07 billion in 2024 (CAGR of 12.3%) and is expected to reach $36.87 billion in 2028.
• The company has secured distribution agreements with ISFLST, Inc. for Asia Pacific and Latin America (excluding Mexico) and Propre Energie Inc. for Dermytol, indicating international expansion efforts.
• Mangoceuticals has acquired patents related to respiratory illness prevention technology and is conducting Phase II clinical trials and efficacy studies, with anticipated completion in Q2 2025.
• The company has a Master Distribution Agreement with Marius Pharmaceuticals, LLC for the FDA-approved oral Testosterone Replacement Therapy (TRT) product, Prime powered by Kyzatrex, expanding its product offerings beyond compounded drugs.
• The company's customer portal provides comprehensive features for customer account management, order history, tracking, refills, and profile changes, enhancing customer experience.
• The company has a strategic focus on data analytics for marketing to measure consumer behavior and optimize marketing budgets and return on investment.
• The company has elected to use the extended transition period for complying with new or revised financial accounting standards as an emerging growth company, potentially reducing compliance costs.

Negatives

• The company reported a net loss of $8,707,226 for the year ended December 31, 2024, and an accumulated deficit of $20,806,595, indicating significant financial challenges.
• Revenues decreased to $615,873 in 2024 from $731,493 in 2023, a decline mainly attributed to issues with telemedicine platform transition.
• The net loss for the three months ended March 31, 2025, increased to $4,839,489 from $2,367,617 in the same period of 2024, primarily due to increased legal expenses, technology development costs, and intellectual property acquisition-related expenses.
• The company's current capital resources are not expected to be sufficient to fund operations for the next 12 months, necessitating additional funding.
• The company has a limited operating history and has generated only limited revenues to date, with no assurance of future revenue generation or profitability.
• Advertising and marketing expenses decreased significantly from $2,097,505 in 2023 to $1,478,663 in 2024, and from $852,383 in Q1 2024 to $281,732 in Q1 2025, indicating reduced market outreach.
• Investor relations expenses increased substantially from $143,000 in Q1 2024 to $1,419,000 in Q1 2025, suggesting high costs associated with public awareness efforts.
• The company's compounded products are not FDA-approved, meaning their safety, effectiveness, or quality are not verified by the FDA, posing significant litigation and regulatory risks.
• The formulas for compounded products are publicly disclosed and can be replicated by competitors, potentially limiting market differentiation and share.
• The company is heavily reliant on related party transactions, particularly with Epiq Scripts, LLC, which is 52% owned by the CEO, raising potential conflicts of interest and operational risks if the relationship is terminated.
• The company faces intense competition from larger pharmaceutical companies and other wellness providers with greater resources and established brand names.
• The company's stock price has been highly volatile, trading as high as $65.55 and as low as $2.07 per share since its IPO on March 21, 2023.
• The company's common stock is subject to significant dilution from the conversion of Series B and Series C Preferred Stock, exercise of warrants, and future equity financings.
• The company has no intention of declaring dividends on its common stock in the foreseeable future, meaning investors will rely solely on stock appreciation for returns.
• The company is involved in a lawsuit with Eli Lilly and Company for alleged false and misleading advertising, which could result in significant costs, damages, and operational changes.
• The company rescinded agreements with ArcStone, Smokeless, and Strategem on May 22, 2025, indicating a change in strategic direction for oral pouch products, with ArcStone retaining 50,000 shares for services rendered.

Risks

• The company needs additional funding to support operations, and such funding may not be available on favorable terms, if at all, leading to potential curtailment of business plans or decline in security value.
• The company has a limited operating history and has generated only limited revenues, making it difficult for investors to evaluate the business and forecast future performance.
• The independent registered public accounting firm included an explanatory paragraph regarding the company's ability to continue as a going concern, indicating substantial doubt about its ability to meet obligations.
• The company's compounded products (Mango ED, Mango GROW, Mojo, Slim) are not FDA-approved and have not undergone FDA clinical trial protocols, posing risks of serious patient injury, death, costly litigation, significant fines, judgments, or penalties.
• The FDA may determine that the compounding of the company's products does not fall within the Section 503A exemption, potentially prohibiting sales or requiring costly and time-consuming changes to the business plan.
• The publicly disclosed formulas for compounded products can be replicated by competitors, making it difficult for the company to differentiate its products and maintain market share.
• Significant reliance on related party transactions, particularly with Epiq Scripts, LLC (52% owned by CEO Jacob D. Cohen), presents potential conflicts of interest and operational risks if the relationship is terminated or terms are not truly arms-length.
• The company's Telemedicine Providers may face legal challenges or new state actions restricting telehealth services, which could limit the company's ability to connect consumers with medical providers and sell products.
• Disruptions in the global supply chain or inability to find qualified vendors for product compounds could adversely impact the business.
• The company is exposed to risks associated with credit card and online payment chargebacks and fraud, which could lead to financial penalties or termination of payment processing abilities.
• Security breaches, loss of data, or other disruptions to information systems could compromise sensitive customer information, harm reputation, and expose the company to liability.
• The company faces intense competition from larger companies with greater resources, marketing budgets, and established brand names, potentially impacting revenue and market share.
• Changes in consumer tastes, preferences, or economic downturns (e.g., inflation, interest rates) could limit demand for the company's discretionary products.
• The company's Chairman and CEO, Jacob D. Cohen, has significant voting control (9.32% beneficial ownership as of May 27, 2025, and majority control over Mango & Peaches Corp. which holds substantially all assets), which may deter some investors and influence corporate matters.
• The company's outstanding Series B and Series C Preferred Stock include liquidation preferences ($1,100 per Series B share, $20 per Series C share), which could result in common stockholders receiving no consideration upon liquidation.
• The issuance of common stock upon conversion of preferred stock and exercise of warrants will cause immediate and substantial dilution to existing shareholders.
• Certain outstanding warrants include anti-dilution and reset rights, which could cause their exercise price to decrease significantly and result in further dilution.
• The company's common stock price has been highly volatile since its IPO, and there is no guarantee it will continue to trade on the Nasdaq Capital Market, risking delisting.
• The company may become party to additional litigation, mediation, and/or arbitration, which could be costly, divert management attention, and result in significant damages or penalties.
• Future indebtedness could reduce financial flexibility, increase interest expense, and adversely impact operations.
• The company's aggressive growth strategy may strain managerial, administrative, operational, and financial resources, potentially leading to failure if not managed effectively.
• Future acquisitions may disrupt business, be difficult to integrate, and introduce unknown liabilities.
• The company has no intention of declaring dividends on common stock in the foreseeable future, meaning investors rely solely on stock price appreciation.

Future Outlook

Mangoceuticals anticipates needing additional funding to continue operations at current levels and to pay public company costs for the next 12 months, with potential future funding raised through debt or equity offerings. The company plans to continue using its current marketing and management strategies, provide quality products with excellent customer service, and expand operations organically or through acquisitions in the technology, health, and wellness space. They intend to make additional technology enhancements to their platform, further develop and market additional men's health and wellness products, and identify strategic acquisitions. The company expects to launch Dermytol operations in Q3 2025 and complete Phase II clinical trials for its respiratory illness prevention technology in Q2 2025. They also plan to launch new products and offer additional subscription-based offerings to drive revenue growth. However, there is no assurance of obtaining sufficient funding or achieving profitability.

Management Comments

• "We believe that the potential safety risks associated with our Mango ED products are comparable to the safety risks associated with oral formulations of Tadalafil and Sildenafil approved by the FDA for the treatment of ED."
• "We do not expect significant safety risks associated with L-arginine, as the FDA has recognized in its regulations that L-arginine may be safely added as a nutrient to foods."
• "We believe that this overall strategy will drive customer traffic to our platform, including direct type-in traffic and organic online search traffic."
• "We believe our platform provides us cost advantages and efficiencies to offer customers affordable prices and to generate increased revenues over time."
• "We do not anticipate our Mango ED drug suffering from these limitations, as we believe our product is easy to use and that we have priced our product competitively."
• "We believe that most men who suffer from male pattern baldness are unhappy with their situation and would take steps to change that."
• "We believe that our ability to compete depends upon many factors both within and beyond our control, including: our marketing efforts; the flexibility and variety of our product offerings relative to our competitors, and our ability to timely launch new product initiatives; the quality and price of products offered by us and our competitors; our reputation and brand strength relative to our competitors; customer satisfaction; the size and composition of our customer base; the convenience of the experience that we provide; our ability to comply with, and manage the costs of complying with, laws and regulations applicable to our business; and our ability to cost-effectively source and distribute the products we offer and to manage our operation."
• "We believe we can conduct truthful and non-misleading promotional activities, including activities involving the use of testimonials and surrogates, with limited claims that do not require substantial evidence derived from adequate and well-controlled clinical trials and which do not include efficacy claims."
• "We believe that in general, the faster we are able to scale up our operations, the lower our cost of sales, as a percentage of revenue, will be, as we believe that certain economies of scale exist with our operations."
• "We believe our future success depends on our ability to maintain and grow the value of the Mango brand."
• "We believe our facilities are sufficient to meet our current needs and that suitable space will be available as and when needed."
• "The Board of Directors believes that diversity promotes a variety of ideas, judgments and considerations to the benefit of our Company and shareholders."

Industry Context

Mangoceuticals operates within the rapidly expanding and evolving men's wellness and telemedicine industries. The company aims to capitalize on growing sectors such as erectile dysfunction (ED), hair loss, testosterone replacement therapy (TRT), and weight management. While the global ED market is projected to contract to $2.95 billion by 2028 due to poor patient compliance and imitation medicines, the U.S. ED market is expected to grow at a 7.4% CAGR through 2030, reaching approximately $1.1 billion by 2021. The hair loss prevention market is projected to reach $31.5 billion by 2028 (4.2% CAGR), and the male hypogonadism market is expected to reach $5.1 billion by 2030 (5.1% CAGR). The Semaglutide market is experiencing rapid growth, from $20.54 billion in 2023 to $23.07 billion in 2024 (12.3% CAGR), projected to reach $36.87 billion in 2028. Mangoceuticals competes with larger, more established companies like Hims & Hers Health, Inc., Roman, Pfizer (Viagra), Lilly ICOS LLC (Cialis), Merck & Co. (Propecia), and Johnson & Johnson (Rogaine). The company differentiates itself through unique compounding and sublingual delivery systems for its non-FDA-approved products and by offering a premium price point. The industry is subject to complex and evolving federal and state regulations, particularly concerning telehealth, corporate practice of medicine, fee splitting, and FDA oversight of compounded drugs, which poses significant compliance challenges.

Comparison to Industry Standards

• Mangoceuticals competes with Hims & Hers Health, Inc. and Roman in the broader men's wellness telemedicine space, which are generally larger and more established.
• For ED products, Mangoceuticals competes directly with major pharmaceutical companies like Pfizer (Viagra) and Lilly ICOS LLC (Cialis), and their generic forms, which have significantly greater resources and well-known brand names.
• For hair loss products, Mangoceuticals competes with Merck & Co. (Propecia) and Johnson & Johnson (Rogaine), also much larger entities with established market presence.
• The company's compounded products are not FDA-approved, unlike many traditional pharmaceutical products, which means they lack the FDA's verification of safety, effectiveness, or quality, a significant difference from industry standards for approved drugs.
• Mangoceuticals' use of sublingual rapid dissolve tablets (RDT) for its compounded products is presented as a competitive advantage over traditional pill forms or injectables offered by competitors, aiming for faster absorption and ease of use.
• While the company believes its Mango ED product is competitively priced, it states it has priced both Mango ED and Mango GROW products at a premium compared to other online direct-to-consumer telemedicine companies selling generic ED and hair loss medications, positioning itself as a premium product provider.
• The company's reliance on a related party compounding pharmacy (Epiq Scripts, 52% owned by CEO) for manufacturing and fulfillment is a deviation from standard third-party manufacturing relationships, introducing related party risks not typically seen with independent contract manufacturers.
• The company's financial performance, with recurring net losses and a going concern warning, contrasts sharply with established, profitable industry players, indicating a significant gap in financial stability and operational maturity.

Management Changes

Corporate Governance

Legal Proceedings

• On October 31, 2024, Eli Lilly and Company filed a complaint against Mangoceuticals in the Northern District of Texas Dallas Division, alleging false and misleading advertising and promotion in violation of Section 43(a)(1)(B) of the Lanham Act, and common law deceptive advertising (later removed).
• The lawsuit specifically targets the company's TRIM product, seeking a declaratory judgment, an injunction against falsely stating FDA approval, clinical studies, or therapeutic outcomes, and requiring corrective advertising.
• Eli Lilly also seeks an order requiring the company to account for and pay all profits from alleged false advertising, compensatory damages (trebled under 15 U.S.C. § 1117), monetary remedies under Texas state law, pre-judgment and post-judgment interest, and attorneys' fees.
• On January 30, 2025, Eli Lilly filed an amended complaint, removing the common law deceptive advertising claim.
• On February 24, 2025, Mangoceuticals filed its response along with affirmative defenses and a motion to dismiss.
• Management responded to the lawsuit by removing allegedly offending references to FDA studies from its website, and the TRIM product is no longer identified or available for purchase on MangoRx.com.
• The company is attempting to resolve the matter but intends to vigorously defend it if an early resolution is not reached.
• The document notes that the impact and outcome of litigation are subject to inherent uncertainties, and an adverse result could harm the business.

Related Party Transactions

• **Epiq Scripts, LLC**: Master Services Agreement (effective August 30, 2022) and Consulting Agreement (September 15, 2023) for exclusive pharmacy, compounding, packaging, shipping, and distribution services. Epiq Scripts is 52% owned and controlled by Jacob D. Cohen, the company's Chairman and CEO. The company paid Epiq Scripts $60,000 upfront ($45,000 setup fee, $15,000 retainer) and pays fixed fees per prescription/pill. All costs are listed as related party costs of revenues. The Master Services Agreement does not address product liability claims or indemnification for them. On January 30, 2025, these agreements were assigned to Mango & Peaches Corp., a wholly-owned subsidiary.
• **Jacob D. Cohen (CEO & Chairman)**: Holds 52% ownership and control of Epiq Scripts, LLC. His employment agreement was amended (December 13, 2024, effective December 15, 2024, and April 24, 2025, effective April 1, 2025) to increase his base salary to $420,000/year, monthly office allowance to $10,000, and monthly car allowance to $5,000. He is eligible for a cash bonus of up to $10,000,000 based on Mango & Peaches milestones, convertible into up to 20,000,000 shares of Mango & Peaches common stock. He also received 200,000 fully-vested common stock shares as a discretionary bonus on April 10, 2025. He has made his personal credit card available for company purchases, with $1,153,674 repaid as of May 27, 2025. He controls The Tiger Cub Trust, which loaned the company $100,000 on May 2, 2025, at 18% interest.
• **Mango & Peaches Corp.**: A newly formed wholly-owned subsidiary to which substantially all of the company's assets and operations (including MangoRx Mexico S.A. de C.V. and MangoRx UK Limited) were contributed on December 13, 2024 (effective December 15, 2024). Jacob D. Cohen is due to be issued 1,700,000 shares of Mango & Peaches common stock (25.4% ownership) and 100 shares of Series A Super Majority Voting Preferred Stock (51% voting control) in Mango & Peaches, subject to shareholder approval. This restructuring segregates operations and liabilities.
• **LT Global Practice Management**: Entered into an LT Global Practice Management Service Agreement on January 28, 2025, with LT Global, an entity owned by the wife of CEO Jacob D. Cohen, for virtual professional services at rates between $1,800 to $3,500 per full-time virtual professional.
• **Ronin Equity Partners**: Company borrowed $37,500 on March 1, 2024, from Ronin Equity Partners, owned and controlled by Jacob D. Cohen. This amount was repaid on October 7, 2024.
• **Cohen Enterprises, Inc.**: Company borrowed $50,000 on March 18, 2024, and $100,000 on April 1, 2024, from Cohen Enterprises, Inc., owned and controlled by Jacob D. Cohen. These loans were memorialized in a $150,000 promissory note (Cohen Note) on October 18, 2024, bearing 8% interest. On December 13, 2024, Cohen Enterprises sold its rights under the Cohen Note to Mill End Capital Ltd., making it no longer a related party note.
• **PHX Global, LLC**: Consulting agreements (September 6, 2022, renewed November 7, 2023, amended April 25, 2024, extended September 27, 2024) for consulting and general business advisory services. PHX is owned by Peter Casey Jensen, a former director of American International (former majority shareholder of Mangoceuticals). The company issued PHX 3,333, 13,333, 13,333, and 13,333 shares of restricted common stock respectively for these services.
• **Greentree Financial Group, Inc.**: Service agreements (September 22, 2022, renewed September 1, 2023, and December 2, 2024) for bookkeeping, financial reporting conversion, compliance filings, and consulting services. Eugene M. Johnston, the company's CFO, has served as Audit Manager for Greentree since February 2015. The company issued Greentree 100,000, 5,000, and 40,000 shares of restricted common stock and paid cash fees for these services.
• **Consultants (Epiq Scripts employees)**: On January 24, 2023, the company entered into Consulting Agreements with Sultan Haroon, John Helfrich, Justin Baker, and Maja Matthews (all employees of Epiq Scripts) for research, development, packaging, and marketing services, issuing an aggregate of 23,332 shares of common stock.
• **Disposal of Equipment to Epiq Scripts**: On May 15, 2024, the company disposed of $119,819 of equipment to Epiq Scripts for $65,000, realizing a loss of $18,387. This was stated as an arms-length transaction.

Stakeholder Impact

• **Shareholders**: Face significant dilution from the conversion of Series B and Series C Preferred Stock, exercise of warrants, and future equity financings. The company's recurring net losses and going concern warning pose a high risk of investment loss. The CEO's significant voting control over the company and its core operating subsidiary (Mango & Peaches Corp.) may limit the influence of other shareholders on corporate matters. No dividends are expected in the foreseeable future, meaning returns depend solely on stock appreciation.
• **Employees**: The company's aggressive growth strategy and plans for technology enhancements and product expansion could lead to new job opportunities. However, the company's financial instability and need for additional funding could also pose risks to job security if funding is not secured or operations are curtailed. Executive officers and directors receive substantial equity-based compensation, aligning their interests with share performance, but also contributing to potential dilution for other shareholders.
• **Customers**: The company aims to provide affordable men's wellness products through a convenient telemedicine platform and subscription plans. However, the non-FDA-approved status of compounded products carries potential safety risks and could lead to product recalls or litigation, impacting customer trust and access to products. The ongoing lawsuit with Eli Lilly could also affect product availability and marketing claims.
• **Suppliers/Vendors**: The company's reliance on third-party transportation providers and its exclusive reliance on Epiq Scripts (a related party) for compounding services means their financial health and operational stability are crucial. Any disruptions or failures from these parties could impact the company's ability to deliver products, potentially affecting supplier relationships and payments.
• **Creditors**: The company's recurring net losses, accumulated deficit, and going concern warning indicate a high risk for creditors. The company's need for future debt financing could increase its vulnerability to default. The Promissory Notes with Indigo Capital LP and The Tiger Cub Trust bear high interest rates (18%), indicating a higher risk profile for lenders.

Next Steps

• The company will continue to use its current marketing and management strategies to attract customers and provide customer service.
• The company plans to make additional and ongoing technology enhancements to its platform.
• The company intends to further develop, market, and advertise additional men's health and wellness related products on its telemedicine platform.
• The company plans to identify strategic acquisitions that complement its vision, funding permitting.
• The company anticipates completing Phase II clinical trials and efficacy studies for its patented respiratory illness prevention technology in the 2nd quarter of 2025.
• The company intends to commence operations surrounding the Dermytol brand (plant-based skincare formulations) in the 3rd quarter of 2025.
• Epiq Scripts intends to obtain a state license from Alabama by the end of the second quarter of 2025 to provide national coverage.
• The company expects to solicit shareholder approval for the issuance of Mango & Peaches shares to Mr. Jacob Cohen in the near future.
• The company intends to vigorously defend the lawsuit filed by Eli Lilly and Company if an early resolution is not reached.
• The company plans to implement a policy prohibiting hedging transactions by employees in the future.
• The company will need to raise additional funding to support its operations for the next 12 months, likely through debt or equity offerings.

Key Dates

Recommendation

Keywords

Telemedicine, Men's Wellness, Erectile Dysfunction, Hair Loss, Hormone Therapy, Weight Management, Compounded Drugs, FDA Exemption, S-1 Filing, SEC Registration, Share Resale, Dilution, Going Concern, Related Party Transactions, Intellectual Property, Litigation Risk, Nasdaq, Pharmaceutical Products, Sublingual Delivery, Preferred Stock, Warrants, Capital Raise, Strategic Alternatives