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Mangoceuticals Acquires Global Patent Portfolio to Revolutionize Preventive Care
Newsfilter· 2024-04-25 12:30
Provides MangoRx with entrance into the non-Rx based, nutraceutical product space for sales on both direct-to-consumer online platforms and through retail locations Dallas, Texas, April 25, 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 in the area of erectile dysfunction (ED), hair growth and hormone replacement therapies is excited to announce that it has acqui ...
Mangoceuticals(MGRX) - 2023 Q4 - Annual Report
2024-04-01 21:21
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-K (Mark One) ☒ ANNUAL REPORT UNDER SECTION 13 OR 15(D) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 31, 2023 ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 Commission File Number: 001-41615 Mangoceuticals, Inc. (Exact name of registrant as specified in its charter) | Texas | | 87-3841292 | | --- | --- | --- | | (State or other jurisdiction of | | (I.R.S. Em ...
Mangoceuticals(MGRX) - 2023 Q3 - Quarterly Report
2023-10-27 20:15
```markdown [PART I – FINANCIAL INFORMATION](index=5&type=section&id=PART%20I%20%E2%80%93%20FINANCIAL%20INFORMATION) [Financial Statements](index=5&type=section&id=Item%201.%20Financial%20Statements) Presents unaudited consolidated financial statements for Q3 2023, showing initial revenue generation but a significant increase in net loss [Balance Sheets](index=5&type=section&id=Balance%20Sheets) Balance Sheet Comparison (Unaudited) | Metric | September 30, 2023 | December 31, 2022 | | :--- | :--- | :--- | | **Assets** | | | | Cash and cash equivalents | $1,236,747 | $682,860 | | Total Current Assets | $1,342,710 | $694,605 | | Total Assets | $1,595,505 | $1,003,287 | | **Liabilities & Equity** | | | | Total Current Liabilities | $159,176 | $260,577 | | Total Liabilities | $240,684 | $389,257 | | Total Stockholders' Equity | $1,354,821 | $614,030 | [Statements of Operations](index=6&type=section&id=Statements%20of%20Operations) Statement of Operations Highlights (Unaudited) | Metric | Three Months Ended Sep 30, 2023 | Nine Months Ended Sep 30, 2023 | | :--- | :--- | :--- | | Revenues | $245,160 | $487,119 | | Gross Profit | $144,589 | $288,918 | | Loss from Operations | ($1,799,460) | ($6,650,843) | | Net Loss | ($1,799,460) | ($6,644,370) | | Basic and Diluted Loss Per Share | ($0.11) | ($0.45) | - The company generated revenues in the three and nine months ended September 30, 2023, whereas it had no revenues in the comparable periods of 2022. However, **net loss significantly increased year-over-year**[14](index=14&type=chunk) [Statements of Changes in Stockholders' Equity](index=7&type=section&id=Statements%20of%20Changes%20in%20Stockholders'%20Equity) - Total stockholders' equity increased from **$614,030** at December 31, 2022, to **$1,354,821** at September 30, 2023[17](index=17&type=chunk)[18](index=18&type=chunk) - The increase in equity was primarily driven by the issuance of common stock for cash from the IPO (**$5,000,000**) and warrant exercises (**$1,024,500**), which was partially offset by the net loss for the period[17](index=17&type=chunk)[18](index=18&type=chunk) [Statements of Cash Flows](index=9&type=section&id=Statements%20of%20Cash%20Flows) Cash Flow Summary (Unaudited) | Cash Flow Activity | Nine Months Ended Sep 30, 2023 | Nine Months Ended Sep 30, 2022 | | :--- | :--- | :--- | | Net Cash Used in Operating Activities | ($5,299,634) | ($696,958) | | Net Cash Used in Investing Activities | ($3,519) | ($2,531) | | Net Cash Provided by Financing Activities | $5,857,040 | $1,550,430 | - The significant cash provided by financing activities in 2023 was primarily due to **$5.0 million** from the sale of common stock in the IPO and **$1.02 million** from the exercise of warrants[21](index=21&type=chunk) [Notes to Financial Statements](index=10&type=section&id=Notes%20to%20Financial%20Statements) - The company focuses on developing, marketing, and selling men's wellness products, specifically an erectile dysfunction (ED) product under the brand name "Mango," via a telemedicine platform[23](index=23&type=chunk) - In March 2023, the company completed an Initial Public Offering (IPO), selling **1,250,000 shares** of common stock at **$4.00 per share**, resulting in net proceeds of **$4.35 million**[24](index=24&type=chunk) - The company has a Master Services Agreement with Epiq Scripts, LLC, a related party, to provide pharmacy and compounding services for its products[46](index=46&type=chunk) - As of September 30, 2023, there were **1,400,000 stock options** and **1,063,000 warrants** outstanding[28](index=28&type=chunk)[109](index=109&type=chunk)[113](index=113&type=chunk) [Management's Discussion and Analysis of Financial Condition and Results of Operations](index=26&type=section&id=Item%202.%20Management's%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Management discusses financial performance, increased expenses, and liquidity challenges requiring additional funding [Overview](index=27&type=section&id=Overview) - The company operates a telehealth platform connecting consumers with licensed healthcare professionals and a pharmacy for the fulfillment of prescribed medications, focusing on men's wellness and erectile dysfunction (ED) with its "Mango" branded product[134](index=134&type=chunk)[135](index=135&type=chunk) - The "Mango" ED product is a compounded drug made from a proprietary combination of ingredients including Sildenafil or Tadalafil, Oxytocin, and L-Arginine. It is not FDA-approved but is produced under the pharmacy compounding exemption of Section 503A of the Federal Food, Drug, and Cosmetic Act[135](index=135&type=chunk) [Key Performance Indicators](index=28&type=section&id=Key%20Performance%20Indicators) Average Order Value (AOV) - Q3 2023 | Customer Type | AOV | | :--- | :--- | | Subscribing Customers | $130.27 | | Non-Subscribing Customers | $105.35 | Customer Breakdown - Q3 2023 | Customer Type | Percentage | | :--- | :--- | | Subscribing Customers | 11% | | Non-Subscribing Customers | 89% | [Results of Operations](index=29&type=section&id=Results%20of%20Operations) Financial Results Summary | Metric | Three Months Ended Sep 30, 2023 | Nine Months Ended Sep 30, 2023 | | :--- | :--- | :--- | | Revenues | $245,160 | $487,119 | | Gross Profit | $144,589 | $288,918 | | General & Admin Expenses | $1,944,049 | $6,939,761 | | Net Loss | ($1,799,460) | ($6,644,370) | - The company began generating revenues in November 2022. The increase in general and administrative expenses in 2023 was primarily due to higher stock-based compensation, advertising and marketing, legal fees related to the IPO, and increased salaries as operations expanded[145](index=145&type=chunk)[149](index=149&type=chunk) [Liquidity and Capital Resources](index=31&type=section&id=Liquidity%20and%20Capital%20Resources) - As of September 30, 2023, the company had **$1.24 million** in cash and **$1.2 million** in working capital[151](index=151&type=chunk)[152](index=152&type=chunk) - Management has concluded that current capital resources are **insufficient to fund operations for the next 12 months**, and the company will need to raise additional funding[154](index=154&type=chunk)[169](index=169&type=chunk) - The company raised approximately **$5 million** in gross proceeds from its IPO in March 2023 and **$2 million** from a private placement in 2022[164](index=164&type=chunk)[165](index=165&type=chunk)[166](index=166&type=chunk) [Quantitative and Qualitative Disclosures about Market Risk](index=34&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20about%20Market%20Risk) Exempt from market risk disclosures as a "smaller reporting company" under SEC regulations - As a "smaller reporting company," Mangoceuticals, Inc. is not required to provide the information for this item[175](index=175&type=chunk) [Controls and Procedures](index=34&type=section&id=Item%204.%20Controls%20and%20Procedures) Disclosure controls and procedures were effective as of September 30, 2023, with no material changes - Based on an evaluation as of September 30, 2023, the Chief Executive Officer and Chief Financial Officer concluded that the company's disclosure controls and procedures were effective[176](index=176&type=chunk) - There were no changes in the company's internal control over financial reporting during the third quarter of 2023 that materially affected, or are reasonably likely to materially affect, internal controls[177](index=177&type=chunk) [PART II – OTHER INFORMATION](index=35&type=section&id=PART%20II%20%E2%80%93%20OTHER%20INFORMATION) [Legal Proceedings](index=35&type=section&id=Item%201.%20Legal%20Proceedings) The company is not currently a party to any material legal or governmental proceedings - The company is not currently a party to any material legal proceedings[180](index=180&type=chunk) [Risk Factors](index=35&type=section&id=Item%201A.%20Risk%20Factors) Significant risks include funding, related-party reliance, non-FDA approved product, competition, and Nasdaq compliance - The company has a limited operating history, has experienced recurring net losses, and its current capital resources are **not sufficient to fund operations for the next 12 months**, raising questions about its ability to continue as a going concern[187](index=187&type=chunk)[188](index=188&type=chunk)[191](index=191&type=chunk) - The company's Mango ED product is not FDA-approved and has not undergone clinical trials, which exposes the company to risks of serious patient injury, litigation, and governmental action[256](index=256&type=chunk)[257](index=257&type=chunk) - The company is significantly reliant on related-party transactions, especially its Master Services Agreement with Epiq Scripts, LLC, a pharmacy **51% owned and controlled by the company's CEO**, Jacob D. Cohen[270](index=270&type=chunk)[272](index=272&type=chunk) - As of September 30, 2023, the company was **not in compliance with Nasdaq's continued listing standard** requiring at least **$2.5 million in stockholders' equity**, which could lead to delisting[305](index=305&type=chunk) [Unregistered Sales of Equity Securities and Use of Proceeds](index=69&type=section&id=Item%202.%20Unregistered%20Sales%20of%20Equity%20Securities%20and%20Use%20of%20Proceeds) Discloses unregistered stock sale to a consultant and consistent use of $4.35 million IPO proceeds - On October 10, 2023, the company issued **200,000 shares** of restricted common stock to Luca Consulting for advisory services. This issuance was exempt from registration under Section 4(a)(2) of the Securities Act[341](index=341&type=chunk)[342](index=342&type=chunk) - The company confirms no material change in the use of the approximately **$4.35 million** in net proceeds from its March 2023 IPO, which are intended for product development, marketing, and working capital[344](index=344&type=chunk)[346](index=346&type=chunk) [Defaults Upon Senior Securities](index=70&type=section&id=Item%203.%20Defaults%20Upon%20Senior%20Securities) The company reports no defaults upon senior securities - None[349](index=349&type=chunk) [Mine Safety Disclosures](index=70&type=section&id=Item%204.%20Mine%20Safety%20Disclosures) This item is not applicable to the company's operations - Not applicable[350](index=350&type=chunk) [Other Information](index=71&type=section&id=Item%205.%20Other%20Information) Adoption of a Clawback Policy on October 26, 2023, enables recovery of erroneously awarded incentive compensation - On October 26, 2023, the Board of Directors adopted a Policy for the Recovery of Erroneously Awarded Incentive Based Compensation (the "Clawback Policy") to comply with SEC Rule 10D-1 and Nasdaq Listing Rule 5608[353](index=353&type=chunk) - The policy mandates the recovery of excess incentive-based compensation from current and former executive officers received during the **three fiscal years** preceding an accounting restatement, regardless of fault[354](index=354&type=chunk) [Exhibits](index=71&type=section&id=Item%206.%20Exhibits) Provides a list of all exhibits filed with the Form 10-Q, including SOX certifications and the new Clawback Policy - The report includes a list of filed exhibits, such as the company's Certificate of Formation, Bylaws, various material contracts, and required certifications under the Sarbanes-Oxley Act[356](index=356&type=chunk)[357](index=357&type=chunk)[358](index=358&type=chunk) - A key new exhibit filed is the "Policy for the Recovery of Erroneously Awarded Incentive-Based Compensation" (Clawback Policy)[358](index=358&type=chunk) ```
Mangoceuticals(MGRX) - 2023 Q2 - Quarterly Report
2023-07-28 20:15
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal quarter ended June 30, 2023 ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 FOR THE TRANSITION PERIOD FROM _____________ TO _____________ Commission File Number 001-41615 Mangoceuticals, Inc. (Exact name of registrant as specified in its charter) Texas 87-3841292 (State ...
Mangoceuticals(MGRX) - 2023 Q1 - Quarterly Report
2023-05-09 22:26
[CAUTIONARY STATEMENT REGARDING FORWARD-LOOKING INFORMATION](index=4&type=section&id=CAUTIONARY%20STATEMENT%20REGARDING%20FORWARD-LOOKING%20INFORMATION) This report contains forward-looking statements, subject to risks and uncertainties that may cause actual results to differ materially - This report contains forward-looking statements that are not guarantees of future performance, involving known and unknown risks and uncertainties[9](index=9&type=chunk) - Key factors that could cause actual results to differ materially include: - Ability to obtain additional funding and manage COVID-19 effects[10](index=10&type=chunk) - Capacity to build brand, expand operations, and increase sales[10](index=10&type=chunk) - Compliance with regulations affecting operations, manufacturing, and labeling[10](index=10&type=chunk) - Competition from existing and new products[10](index=10&type=chunk) - Dependency on third parties for prescribing and compounding its erectile dysfunction (ED) product[10](index=10&type=chunk) - Potential safety risks associated with its Mango ED product[10](index=10&type=chunk) - Macroeconomic factors like high inflation, interest rates, and economic downturns[10](index=10&type=chunk) - Ability to protect intellectual property and retain key personnel[10](index=10&type=chunk) PART I – FINANCIAL INFORMATION [Financial Statements](index=5&type=section&id=Item%201.%20Financial%20Statements) This section presents the company's unaudited Q1 2023 financial statements, reflecting initial revenue, increased losses, and a strengthened balance sheet post-IPO [Balance Sheets](index=5&type=section&id=Balance%20Sheets) Total assets increased to **$4.1 million** from **$1.0 million** due to IPO cash, with liabilities decreasing and equity growing to **$3.8 million** Balance Sheet Summary (Unaudited) | Metric | March 31, 2023 ($) | December 31, 2022 ($) | | :--- | :--- | :--- | | **Assets** | | | | Cash equivalents | $3,791,216 | $682,860 | | Total Current Assets | $3,822,491 | $694,605 | | Total Assets | $4,115,285 | $1,003,287 | | **Liabilities & Equity** | | | | Total Current Liabilities | $182,842 | $260,577 | | Total Liabilities | $296,109 | $389,257 | | Total Stockholders' Equity | $3,819,176 | $614,030 | [Statements of Operations](index=6&type=section&id=Statements%20of%20Operations) Q1 2023 generated first revenues of **$100,722** and gross profit of **$57,199**, but surging expenses resulted in a **$2.56 million** net loss Statement of Operations Summary (Unaudited) | Metric | Three Months Ended Mar 31, 2023 ($) | Three Months Ended Mar 31, 2022 ($) | | :--- | :--- | :--- | | Revenues | $100,722 | $0 | | Gross Profit | $57,199 | $0 | | General and administrative expenses | $2,616,324 | $18,710 | | Net Loss | $(2,560,885) | $(19,599) | | Basic and Diluted Loss Per Share | $(0.23) | $(0.00) | [Statements of Changes in Stockholders' Equity (Deficit)](index=7&type=section&id=Statements%20of%20Changes%20in%20Stockholders%27%20Equity%20%28Deficit%29) Stockholders' equity grew to **$3.8 million** by Q1 2023, primarily from **$5 million** IPO proceeds and **$700,000** for services, offset by a **$2.56 million** net loss Changes in Stockholders' Equity (Q1 2023) | Description | Amount ($) | | :--- | :--- | | Balance, December 31, 2022 | $614,030 | | Issuance of common stock for cash | $5,000,000 | | Issuance of common stock for services | $700,000 | | Net loss | $(2,560,885) | | Other adjustments | $66,031 | | **Balance, March 31, 2023** | **$3,819,176** | [Statements of Cash Flows](index=8&type=section&id=Statements%20of%20Cash%20Flows) Q1 2023 net cash used in operations was **$1.8 million**, offset by **$4.9 million** from financing, leading to a **$3.1 million** net increase and **$3.79 million** cash balance Cash Flow Summary (Unaudited) | Cash Flow Activity | Three Months Ended Mar 31, 2023 ($) | Three Months Ended Mar 31, 2022 ($) | | :--- | :--- | :--- | | Net Cash Used in Operating Activities | $(1,809,865) | $(18,710) | | Net Cash Used in Investing Activities | $(3,519) | $0 | | Net Cash Provided by Financing Activities | $4,921,740 | $50,000 | | **Net Increase in Cash** | **$3,108,356** | **$31,290** | | Cash at End of Period | $3,791,216 | $53,840 | [Notes to Financial Statements](index=9&type=section&id=Notes%20to%20Financial%20Statements) Notes detail business, accounting policies, and financial components, covering the **$5 million** IPO, related-party transactions, and subsequent warrant exercises - The company focuses on developing and selling men's wellness products, primarily its 'Mango' brand erectile dysfunction (ED) product, through a telemedicine platform[24](index=24&type=chunk) - In March 2023, the company completed an IPO, issuing **1,250,000** shares of common stock at **$4.00** per share, raising net proceeds of **$4.35 million** after costs[26](index=26&type=chunk) - The company has a Master Services Agreement with Epiq Scripts, LLC, a related party controlled by the company's CEO, to provide pharmacy and compounding services[51](index=51&type=chunk) - Subsequent to the quarter end, multiple warrant holders exercised warrants to purchase a total of **450,000** shares of common stock for **$450,000** in cash proceeds in April and May 2023[110](index=110&type=chunk)[111](index=111&type=chunk)[112](index=112&type=chunk) [Management's Discussion and Analysis of Financial Condition and Results of Operations](index=23&type=section&id=Item%202.%20Management%27s%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Management discusses Q1 2023 performance, noting initial revenues, a **$2.56 million** net loss from increased expenses, and improved liquidity from **$5 million** IPO proceeds [Overview](index=24&type=section&id=Overview) The company offers telehealth for men's wellness, selling its non-FDA-approved 'Mango' ED product, a compounded drug, under a Section 503A exemption - The company markets a new brand of ED product named "Mango," which is produced at a compounding pharmacy and requires a physician's prescription[130](index=130&type=chunk) - The Mango ED product contains Tadalafil, Oxytocin, and L-Arginine and is formulated as a Rapid Dissolve Tablet (RDT) for sublingual delivery[130](index=130&type=chunk)[135](index=135&type=chunk) - The product is not and will not be approved by the FDA; it is sold under an exemption provided by Section 503A of the Federal Food, Drug, and Cosmetic Act[130](index=130&type=chunk) [Results of Operations](index=26&type=section&id=Results%20of%20Operations) Q1 2023 generated first revenues of **$100,722** and gross profit of **$57,199**, but G&A expenses surged to **$2.6 million**, resulting in a **$2.56 million** net loss Q1 2023 vs Q1 2022 Performance | Metric | Q1 2023 ($) | Q1 2022 ($) | | :--- | :--- | :--- | | Revenues | $100,722 | $0 | | Gross Profit | $57,199 | $0 | | General & Administrative Expenses | $2,616,324 | $18,710 | | Net Loss | $(2,560,885) | $(19,599) | - The significant increase in G&A expenses in Q1 2023 was primarily due to: - Stock-based compensation: **$764,271**[145](index=145&type=chunk) - Placement agent fees for IPO: **$400,000**[145](index=145&type=chunk) - Advertising and marketing: **$284,366**[145](index=145&type=chunk) - Legal fees related to IPO: **$139,579**[145](index=145&type=chunk) - Salaries and benefits: **$173,839**[145](index=145&type=chunk) [Liquidity and Capital Resources](index=27&type=section&id=Liquidity%20and%20Capital%20Resources) Cash increased to **$3.8 million** by Q1 2023 from **$0.7 million** due to the **$5 million** IPO, with **$3.6 million** working capital, sufficient for 12 months Liquidity Position | Metric | March 31, 2023 ($) | December 31, 2022 ($) | | :--- | :--- | :--- | | Cash on-hand | $3,791,216 | $682,860 | | Working Capital | $3,600,000 | $434,028 | | Total Assets | $4,115,285 | $1,003,287 | | Total Liabilities | $296,109 | $389,257 | - The increase in cash was mainly due to the consummation of its IPO on March 23, 2023, which raised gross proceeds of approximately **$5 million**[160](index=160&type=chunk)[161](index=161&type=chunk) - Management believes current capital resources are sufficient to fund operations for the next 12 months[150](index=150&type=chunk) [Quantitative and Qualitative Disclosures about Market Risk](index=31&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20about%20Market%20Risk) The company is a "smaller reporting company" as defined by SEC rules and is therefore not required to provide the information for this item - As a "smaller reporting company," the Company is not required to provide the information required by this Item[172](index=172&type=chunk) [Controls and Procedures](index=31&type=section&id=Item%204.%20Controls%20and%20Procedures) Management concluded disclosure controls and procedures were effective, with no material changes to internal control over financial reporting during the quarter - Management, including the CEO and CFO, concluded that the company's disclosure controls and procedures were effective as of March 31, 2023[173](index=173&type=chunk) - There were no changes in internal control over financial reporting during the quarter that materially affected, or are reasonably likely to materially affect, the company's internal control over financial reporting[174](index=174&type=chunk) PART II – OTHER INFORMATION [Legal Proceedings](index=32&type=section&id=Item%201.%20Legal%20Proceedings) The company reports that it is not currently a party to any material legal proceedings and is not aware of any such proceedings being contemplated against it - The company is not currently a party to any material legal proceeding and is not aware of any material legal or governmental proceedings contemplated to be brought against it[178](index=178&type=chunk) [Risk Factors](index=32&type=section&id=Item%201A.%20Risk%20Factors) This section outlines significant risks including limited operating history, dependence on a single non-FDA-approved product, related-party transactions, CEO control, competition, and regulatory hurdles [Risks Related to Operating History and Need for Funding](index=34&type=section&id=Risks%20Related%20to%20our%20Operating%20History%20and%20Need%20for%20Funding) The company has limited operating history, minimal revenue, and recurring losses, with a Q1 2023 net loss of **$2.56 million** and **$4.58 million** accumulated deficit, requiring future funding - The company was recently formed, has a limited operating history, and has generated only limited revenues to date[186](index=186&type=chunk) Financial Position and Losses | Metric | As of/For the Three Months Ended March 31, 2023 ($) | | :--- | :--- | | Net Loss | $2,560,885 | | Accumulated Deficit | $4,576,641 | - The company anticipates needing additional capital beyond the IPO proceeds to support future operations, which may not be available or could be dilutive to shareholders[187](index=187&type=chunk)[190](index=190&type=chunk) [Risks Related to Business Activities](index=35&type=section&id=Risks%20Related%20to%20Our%20Business%20Activities) The company faces intense competition, depends on its single ED product compounded by a related-party pharmacy licensed in 44 states, and is exposed to fraud and data security risks - The company faces intense competition from larger, more established companies in the men's wellness and ED market, including Hims & Hers Health, Roman, Pfizer (Viagra), and Eli Lilly (Cialis)[196](index=196&type=chunk) - The company relies on a related-party pharmacy, Epiq Scripts, which is licensed in only **44** states, limiting the company's addressable market until additional state licenses are obtained[202](index=202&type=chunk) - The business is exposed to risks associated with credit card chargebacks, payment fraud, and security breaches of sensitive customer data, including health information[220](index=220&type=chunk)[223](index=223&type=chunk) [Risks Related to Legal, Regulatory and Government](index=44&type=section&id=Risks%20Related%20to%20Legal%2C%20Regulatory%20and%20Government) The company's business relies on its non-FDA-approved ED product qualifying for a Section 503A exemption, facing risks of FDA deeming it an "essential copy" and navigating complex regulations - The company's Mango ED product is not FDA-approved and has not undergone clinical trials for safety and efficacy; its sale relies on an exemption under Section 503A of the FFDCA, which is not guaranteed[249](index=249&type=chunk)[253](index=253&type=chunk) - There is a risk the FDA may determine the product is "essentially a copy" of a commercially available FDA-approved drug, which would prohibit the company from compounding and selling it[238](index=238&type=chunk)[253](index=253&type=chunk) - The business is subject to extensive and complex healthcare regulations, including state-specific laws on telehealth, corporate practice of medicine, and federal privacy laws like HIPAA[237](index=237&type=chunk)[256](index=256&type=chunk)[259](index=259&type=chunk) [Risks Related to Related Party Relationships and Transactions and Our Management](index=50&type=section&id=Risks%20Related%20to%20Related%20Party%20Relationships%20and%20Transactions%20and%20Our%20Management) The company is heavily dependent on CEO Jacob D. Cohen, who holds **51.7%** voting control, making it a "controlled company" and engaging in significant related-party transactions - Chairman and CEO Jacob D. Cohen beneficially owns approximately **51.7%** of the company's common stock, giving him majority voting control over all corporate matters[268](index=268&type=chunk) - Due to Mr. Cohen's majority ownership, the company is deemed a "controlled company" under Nasdaq rules and can elect to be exempt from certain corporate governance requirements[272](index=272&type=chunk) - The company is significantly reliant on related-party transactions, particularly its Master Services Agreement with Epiq Scripts, a pharmacy **51%** owned and controlled by the CEO, which presents potential conflicts of interest[265](index=265&type=chunk)[266](index=266&type=chunk) [Risks Related to Our Securities](index=55&type=section&id=Risks%20Related%20to%20Our%20Securities) The company's stock price is highly volatile due to its small public float, risking Nasdaq delisting if it falls below **$1.00**, and future warrant exercises could cause dilution - The company's common stock has experienced extreme volatility since its IPO, trading as high as **$4.37** and as low as **$0.86** per share, a risk heightened by its small public float[292](index=292&type=chunk)[301](index=301&type=chunk) - There is a risk of being delisted from Nasdaq if the company fails to meet continued listing standards, such as maintaining a minimum bid price of **$1.00** per share[298](index=298&type=chunk) - As of the report date, there were **1,637,500** warrants outstanding; the exercise of these warrants could cause substantial dilution to existing shareholders and may depress the market price of the common stock[307](index=307&type=chunk) [Unregistered Sales of Equity Securities and Use of Proceeds](index=63&type=section&id=Item%202.%20Unregistered%20Sales%20of%20Equity%20Securities%20and%20Use%20of%20Proceeds) No unregistered equity sales in Q1 2023; **$4.35 million** net IPO proceeds are allocated to marketing (**41%**), working capital (**31%**), personnel (**21%**), and software (**7%**) - There were no sales of unregistered securities during the quarter ended March 31, 2023[332](index=332&type=chunk) - The company received net proceeds of approximately **$4.35 million** from its IPO in March 2023[342](index=342&type=chunk) Planned Use of IPO Net Proceeds | Use of Proceeds | Amount ($) | Percentage (%) | | :--- | :--- | :--- | | Marketing & Operational Expenses | $1,804,000 | ~41% | | Working Capital | $1,359,000 | ~31% | | Hiring Additional Personnel | $902,000 | ~21% | | Capital Expenditures (Software) | $287,000 | ~7% | [Defaults Upon Senior Securities](index=65&type=section&id=Item%203.%20Defaults%20Upon%20Senior%20Securities) None reported - None[348](index=348&type=chunk) [Mine Safety Disclosures](index=65&type=section&id=Item%204.%20Mine%20Safety%20Disclosures) Not applicable - Not applicable[349](index=349&type=chunk) [Other Information](index=65&type=section&id=Item%205.%20Other%20Information.) None reported - None[350](index=350&type=chunk) [Exhibits](index=66&type=section&id=Item%206.%20Exhibits) This section lists all exhibits filed with Form 10-Q, including SOX certifications by executive officers and corporate documents - The report includes a list of exhibits filed, such as the Certificate of Formation, Bylaws, various material contracts, and executive employment agreements[352](index=352&type=chunk) - Certifications from the Principal Executive Officer and Principal Financial Officer pursuant to Sections 302 and 906 of the Sarbanes-Oxley Act are filed as exhibits[356](index=356&type=chunk)