Mangoceuticals, Inc. provides relief for erectile dysfunction (ED) in men through telehealth services.
We plan to connect consumers to licensed healthcare professionals through our recently launched website at www.MangoRX.com for the provision of care via telehealth on our customer portal and plan to also provide access for customers to a licensed pharmacy for online fulfillment and distribution of certain medications that may be prescribed as part of telehealth consultations. To date, we have developed what we believe is a go-to-market strategy inclusive of product development, operations, marketing and advertising; however, we have not produced a significant amount of products and have generated only nominal revenues to date.
We have identified men’s wellness telemedicine services and products as a growing sector in recent years and especially related to the areas of erectile dysfunction (“ED”) products. We have developed and are currently in the process of preparing to commercially market a new brand of ED product under the brand name “Mango.” This product is produced at a compounding pharmacy and is available to patients on the determination of a prescribing physician that the compounded drug is necessary for the individual patient. This product currently includes the following U.S. Food and Drug Administration (“FDA”) approved ingredients: Tadalafil (the active ingredient in Cialis), Oxytocin and L-Arginine, an amino acid that is available as a dietary supplement; however, these FDA approvals do not mean that these ingredients will prove safe when combined into a single formulation to treat ED. We currently offer two dosage levels of our Mango ED product and anticipate doctors prescribing a dosage based on the needs and medical history of the patient. Our Mango ED product currently includes the following ingredients: (1) Tadalafil (10 milligrams (mg)), Oxytocin (100 International units (IU)) and L-Arginine (50mg); and (2) Tadalafil (20mg), Oxytocin (100IU) and L-Arginine (50mg). Our Mango ED product has not been, and will not be, approved by the FDA and instead we plan to produce and sell our products, including our Mango ED product, under an exemption provided by Section 503A of the Federal Food, Drug, and Cosmetic Act, as discussed below.
We are not aware of any clinical studies involving the administration of tadalafil sublingually at the doses we provide patients, or the compounding of tadalafil, oxytocin, and L-arginine to treat ED, as is contemplated by our ED product. We are, however, aware of other companies that are currently selling oral disintegrating tablets for ED, including those using a combination of Tadalafil and Sildenafil (the active ingredient in Viagra). Additionally, because our Mango ED product is being specially compounded for the customer by a pharmacist with a physician’s prescription and because the ingredients for our Mango ED product will be publicly disclosed, this product formula can be replicated by other companies.
Because our ED product has not been, and will not be, approved by the FDA, our product has not had the benefit of the FDA’s clinical trial protocol which seeks to prevent the possibility of serious patient injury and death. If this were to occur, we could be subject to litigation and governmental action, which could result in costly litigation, significant fines, judgments or penalties.
We currently anticipate using approximately $1.8 million of the net proceeds of this offering to finance the marketing and operational expenses associated with the planned marketing of our Mango ED product. We launched our website in mid-November 2022. To date, we have sold only a small amount of products and generated only nominal revenues. We plan to market and seek to sell commercial quantities of our Mango ED product in the first quarter of 2023 following this offering
Mango has been formulated as a Rapid Dissolve Tablet (“RDT”) using a sublingual (applied under the tongue) delivery system to bypass the stomach and liver. It is a generally established principle that sublingual drug absorption through the oral mucosa is generally faster than drug absorption through the gastrointestinal tract. This is because sublingual drugs that are absorbed through the oral mucosa directly enter the systemic circulation, bypassing the gastrointestinal tract and first-pass metabolism in the liver (see H. Zhang et al., Oral mucosal drug delivery: clinical pharmacokinetics and therapeutic applications, 41 Clin Pharmacokinet 661, 662 (2002). Though the active ingredients that comprise our Mango product are meant to treat ED – an issue that according to a 2018 study published in The Journal of Sexual Medicine has been estimated to affect over one-third of today’s men’s population (with prevalence increasing with age) – we are also aiming to brand ourselves as a lifestyle company marketed to men seeking enhanced sexual vitality, performance, and overall mood and confidence. Mango is expected to be sold exclusively online via our recently launched website at www.MangoRX.com.
**Note: Revenue and net loss figures are for the year ended Dec. 31, 2022.
(Note: Mangoceuticals, Inc. priced its micro-cap IPO on March 20, 2023, at $4,00 – the assumed IPO price – on 1.25 million shares – the same number in the prospectus – to raise $5.0 million. Mangoceuticals filed an S-1/A on Jan. 26, 2023, in which it changed its proposed symbol to “MGRX” from the original proposed symbol of “MNGO” for its listing on the NASDAQ. In that Jan. 26, 2023, SEC filing, Mangoceuticals also stated that the assumed IPO price would be $4.00 – the mid-point of its previous $3.00-to$5.00 range – and kept the number of shares at 1.25 million shares to raise $5.0 million. Mangoceuticals, Inc. filed its S-1 on Jan. 13, 2023; the company filed confidential IPO documents in September 2022.)