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 , 2024
☐
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
incorporation
or organization)
(I.R.S.
Employer
Identification
No.)
15110
N. Dallas Parkway , Suite 600
Dallas ,
Texas
75248
(Address
of principal offices)
(Zip
Code)
Registrant’s
telephone number, including area code: (214) 242-9619
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
Stock, $0.0001 Par Value Per Share
MGRX
The
NASDAQ Stock Market LLC
(The
NASDAQ Capital Market)
Securities
registered pursuant to section 12(g) of the Act:
None.
Indicate
by check mark if the registrant is a well-known seasoned issuer, as defined in Rule 405 of the Securities Act. ☐ Yes ☒ No
Indicate
by check mark if the registrant is not required to file reports pursuant to Section 13 or 15(d) of the Act: ☐ Yes ☒ No
Indicate
by check mark whether the registrant (1) has filed all reports required by Section 13 or 15(d) of the Securities Exchange Act of 1934
during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject
to such filing requirements for the past 90 days. ☒ Yes ☐ No
Indicate
by check mark whether the registrant has submitted electronically every Interactive Data File required to be submitted pursuant to Rule
405 of Regulation S-T (§232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant
was required to submit such files). ☒ Yes ☐ No
Indicate
by check mark whether the Registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, a smaller reporting
company, or an emerging growth company. See the definitions of “ large accelerated filer, ” “ accelerated filer, ”
“ smaller reporting company, ” and “ emerging growth company ” in Rule 12b-2 of the Exchange Act.
Large
accelerated filer
☐
Accelerated
filer
☐
Non-accelerated
filer
☒
Smaller
reporting company
☒
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. ☐
Indicate
by check mark whether the registrant has filed a report on and attestation to its management’s assessment of the effectiveness
of its internal control over financial reporting under Section 404(b) of the Sarbanes-Oxley Act (15 U.S.C. 7262(b)) by the registered
public accounting firm that prepared or issued its audit report. ☐
If
securities are registered pursuant to Section 12(b) of the Act, indicate by check mark whether the financial statements of the registrant
included in the filing reflect the correction of an error to previously issued financial statements. ☐
Indicate
by check mark whether any of those error corrections are restatements that required a recovery analysis of incentive-based compensation
received by any of the registrant’s executive officers during the relevant recovery period pursuant to §240.10D-1(b). ☐
Indicate
by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Act). ☐ Yes ☒ No
On
June 30, 2024, the last day of the registrant’s most recently completed second quarter, the aggregate market value of the Common
Stock held by non-affiliates of the registrant was approximately $ 5,862,777 , based upon the closing price of the registrant’s Common
Stock on the Nasdaq Capital Market of $4.56 on June 28, 2024. For purposes of this response, the registrant has assumed that its directors,
executive officers and beneficial owners of 5% or more of its Common Stock are deemed affiliates of the registrant. For purposes
of calculating the aggregate market value of shares held by non-affiliates, we have assumed that all outstanding shares are held by non-affiliates,
except for shares held by each of our executive officers, directors and 5% or greater stockholders. In the case of 5% or greater stockholders,
we have not deemed such stockholders to be affiliates unless there are facts and circumstances which would indicate that such stockholders
exercise any control over our company, or unless they hold 10% or more of our outstanding common stock. These assumptions should not
be deemed to constitute an admission that all executive officers, directors and 5% or greater stockholders are, in fact, affiliates of
our company, or that there are not other persons who may be deemed to be affiliates of our company. Further information concerning shareholdings
of our officers, directors and principal stockholders is included or incorporated by reference in Part III, Item 12 of this Annual Report
on Form 10-K.
As
of March 20, 2025, the registrant had 5,168,796 shares of its Common Stock, $ 0.0001 par value, outstanding.
DOCUMENTS
INCORPORATED BY REFERENCE
None .
TABLE
OF CONTENTS
Cautionary Statement Regarding Forward-Looking Statements
1
Reverse Stock Split
2
Glossary of Industry Terms
3
PART I
4
Item 1. Business.
4
Item 1A. Risk Factors.
29
Item 1B. Unresolved Staff Comments.
69
Item 1C. Cybersecurity
69
Item 2. Properties.
70
Item 3. Legal Proceedings.
71
Item 4. Mine Safety Disclosures.
71
PART II
72
Item 5. Market for Registrant’s Common Equity, Related Shareholder Matters and Issuer Purchases of Equity Securities.
72
Item 6. [Reserved]
72
Item 7. Management’s Discussion and Analysis of Financial Condition and Results of Operations.
72
Item 7A. Quantitative and Qualitative Disclosures About Market Risk.
89
Item 8. Financial Statements and Supplementary Data.
90
Item 9. Changes in and Disagreements with Accountants on Accounting and Financial Disclosure.
91
Item 9A. Controls and Procedures.
91
Item 9B. Other Information.
92
Item 9C. Disclosure Regarding Foreign Jurisdictions that Prevent Inspections.
92
PART III
93
Item 10. Directors, Executive Officers and Corporate Governance.
93
Item 11. Executive Compensation.
102
Item 12. Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters.
120
Item 13. Certain Relationships and Related Transactions, and Director Independence.
122
Item 14. Principal Accountant Fees and Services.
130
PART
IV
132
Item 15. Exhibits and Financial Statement Schedules.
132
Item 16. Form 10–K Summary.
136
Table of Contents
Cautionary
Statement Regarding Forward-Looking Statements
This
Annual Report on Form 10-K (this “ Report ”) contains forward-looking statements within the meaning of the federal securities
laws, including the Private Securities Litigation Reform Act of 1995, regarding future events and the future results of Mangoceuticals,
Inc. (the “ Company ”) that are based on current expectations, estimates, forecasts, and projections about the industry
in which the Company operates and the beliefs and assumptions of the management of the Company. In some cases, you can identify forward-looking
statements by the following words: “ anticipate, ” “ believe, ” “ continue, ” “ could, ”
“ estimate, ” “ expect, ” “ intend, ” “ may, ” “ ongoing, ”
“ plan, ” “ potential, ” “ predict, ” “ project, ” “ should, ”
or the negative of these terms or other comparable terminology, although not all forward-looking statements contain these words. Forward-looking
statements are not a guarantee of future performance or results, and will not necessarily be accurate indications of the times at, or
by, which such performance or results will be achieved. Forward-looking statements are based on information available at the time the
statements are made and involve known and unknown risks, uncertainties and other factors that may cause our results, levels of activity,
performance or achievements to be materially different from the information expressed or implied by the forward-looking statements in
this Report. Factors that might cause or contribute to such differences include, but are not limited to, those discussed elsewhere in
this Report, including under, or incorporated by reference into, “ Risk Factors ”, which factors include:
●
our
ability to obtain additional funding, the terms of such funding, and dilution caused thereby;
●
the
effect of pandemics on our operations, sales, and the market for our products;
●
our
ability to build and maintain our brand;
●
cybersecurity,
information systems and fraud risks and problems with our websites;
●
our
ability to expand and grow our operations, and successfully market our products;
●
changes
in, and our compliance with, rules and regulations affecting our operations, sales, and/or our products;
●
shipping,
production or manufacturing delays;
●
our
ability to increase sales;
●
regulations
we are required to comply with in connection with our operations, manufacturing, labeling and shipping;
●
competition
from existing competitors or new competitors or products that may emerge;
●
our
dependency on third-parties to prescribe and compound our products;
●
our
ability to establish or maintain relations and/or relationships with third-parties;
●
potential
safety risks associated with our products, including the use of ingredients, combination of such ingredients and the dosages thereof;
●
the
effects of changing inflation and interest rates, 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 ongoing conflict in and around
Israel) and other large-scale crises;
●
our
ability to protect intellectual property rights, claims that we have infringed on intellectual property rights, litigation and the
outcome thereof, claims that we have infringed on intellectual property rights, litigation and the outcome thereof;
●
our
ability to adequately support future growth; and
●
other
risk factors included under “ 1A. Risk Factors ” below.
1
Table of Contents
These
statements are not guarantees of future performance or results. Forward-looking statements are based on information available at the
time the statements are made and involve known and unknown risks, uncertainties and other factors that may cause our results, levels
of activity, performance or achievements to be materially different from the information expressed or implied by the forward-looking
statements in this Report. These factors include those set forth below under “ Item 1A. Risk Factors ”, below.
In
addition, statements that “ we believe ” and similar statements reflect our beliefs and opinions on the relevant subject.
These statements are based on information available to us as of the date of this Annual Report on Form 10-K. While we believe that such
information provides a reasonable basis for these statements, that information may be limited or incomplete. Our statements should not
be read to indicate that we have conducted an exhaustive inquiry into, or review of, all relevant information. These statements are inherently
uncertain, and investors are cautioned not to unduly rely on these statements.
You
should read the matters described in “ Item 1A. Risk Factors ” and the other cautionary statements made in this Report, and
incorporated by reference herein, as being applicable to all related forward-looking statements wherever they appear in this Report.
We cannot assure you that the forward-looking statements in this Report will prove to be accurate and therefore prospective investors
are encouraged not to place undue reliance on forward-looking statements. Other than as required by law, we undertake no obligation to
update or revise these forward-looking statements, even though our situation may change in the future.
Reverse
Stock Split
On
March 25, 2024, at a special meeting of the Company’s stockholders (the “ Special Meeting ”), the stockholders
of the Company approved an amendment to our Certificate of Formation, as amended and restated, to effect a reverse stock split of our
issued and outstanding shares of our common stock, par value $0.0001 per share, by a ratio of between one-for-two to one-for-fifty inclusive,
with the exact ratio to be set at a whole number to be determined by our Board of Directors or a duly authorized committee thereof in
its discretion, at any time after approval of the amendment and prior to March 25, 2025 (the “ Stockholder Authority ”).
On
October 7, 2024, the Company’s Board of Directors (the “ Board ”), with the Stockholder Authority, approved an
amendment to our Certificate of Formation, as amended and restated, to effect a reverse stock split of our common stock at a ratio of
1-for-15 (the “ Reverse Stock Split ”). The Reverse Stock Split is more fully described in the Company’s definitive
proxy statement, which was filed with the Commission on March 1, 2024.
On
October 8, 2024, we filed a Certificate of Amendment to our Certificate of Formation, as amended and restated (the “ Certificate
of Amendment ”) with the Secretary of State of the State of Texas to affect the Reverse Stock Split.
Pursuant
to the Certificate of Amendment, the Reverse Stock Split became effective on October 16, 2024, at 12:01 a.m. Eastern Time (the “ Effective
Time ”). The shares of the Company’s common stock began trading on the Nasdaq Capital Market (“ Nasdaq ”)
on a post-split basis on October 16, 2024, with new CUSIP number: 56270V205. No change was made to the trading symbol for the Company’s
shares of common stock, “ MGRX ”, in connection with the Reverse Stock Split.
At
the Effective Time, every fifteen (15) shares of issued and outstanding common stock were converted into one (1) share of issued and
outstanding common stock, and the total outstanding shares of common stock were reduced from approximately 35.5 million to approximately
2.4 million, without giving effect to any rounding up of fractional shares.
2
Table of Contents
No
fractional shares were issued in connection with the Reverse Stock Split. Stockholders of record who otherwise would be entitled to receive
fractional shares, were entitled to have their fractional shares rounded up to the nearest whole share. No stockholders received cash
in lieu of fractional shares. Shortly after the Reverse Stock Split, and upon a comprehensive review, the Company became aware and was
informed of highly irregular trading patterns and an unprecedented increase in the number of shareholder
accounts resulting in concerns about potential stock manipulation. The Company continues to monitor and investigate this matter and has
approved certain round up share requests on a case-by-case basis.
In
addition, the number of shares of common stock issuable upon exercise of our stock options and other equity awards (including shares
reserved for issuance under the Company’s equity compensation plan) were proportionately adjusted by the applicable administrator,
using the 1-for-15 ratio, to be effective at the Effective Time, pursuant to the terms of the Company’s equity plans. In addition,
the exercise price for each outstanding stock option and warrant will be increased in inverse proportion to the 1-for-15 split ratio
such that upon an exercise, the aggregate exercise price payable by the optionee or warrant holder to the Company for the shares subject
to the option or warrant will remain approximately the same as the aggregate exercise price prior to the Reverse Stock Split, subject
to the terms of such securities. Similar changes were made to other outstanding convertible securities.
The
effects of the Reverse Stock Split have been retroactively reflected throughout this Report unless otherwise stated.
Glossary
of Industry Terms
The
following are abbreviations, acronyms and definitions of certain terms used in this document, which are commonly used in our industry:
“ cGMP ”
means current good manufacturing practice regulations promulgated by the FDA under the authority of the FFDCA. These regulations, which
have the force of law, require that manufacturers, processors, and packagers of drugs, medical devices, some food, and blood take proactive
steps to ensure that their products are safe, pure, and effective.
“ FFDCA ”
means the Federal Food, Drug and Cosmetic Act, which is a set of U.S. laws passed by Congress in 1938 giving authority to the FDA to
oversee the safety of food, drugs, medical devices, and cosmetics.
“ HIPAA ”
means the Health Insurance Portability and Accountability Act of 1996, which has the goal of making it easier for people to keep health
insurance, protect the confidentiality and security of healthcare information and help the healthcare industry control administrative
costs.
“ HITECH ”
means the Health Information Technology for Economic and Clinical Health Act.
“ IU ”
means International Unit, which is a unit of measurement for the effect, not mass of a substance; the variance is based on the biological
activity or effect, for the purpose of easier comparison across similar forms of substances. IUs are used to measure the activity of
many vitamins, hormones, enzymes, and drugs.
“ Individually
identifiable health information ” is defined by HIPPA to mean information that is a subset of health information, including
demographic information collected from an individual, and: (1) is created or received by a health care provider, health plan, employer,
or health care clearinghouse; and (2) relates to the past, present, or future physical or mental health or condition of an individual;
the provision of health care to an individual; or the past, present, or future payment for the provision of health care to an individual;
and (a) that identifies the individual; or (b) with respect to which there is reasonable basis to believe the information can be used
to identify the individual.
“ Mg ”
means milligrams.
“ NCPDP ”
means the National Council for Prescription Drug Programs, which is an American National Standards Institute accredited, standards development
organization providing healthcare solutions.
“ NPI ”
means National Provider Identifier, which is a Health Insurance Portability and Accountability Act (HIPAA) Administrative Simplification
Standard. The NPI is a unique identification number for covered health care providers.
“ PII ”
means personal identifiable information.
“ TSBP ”
means The Texas State Board of Pharmacy, which is the state agency responsible for the licensing/registration of Texas pharmacists, pharmacy
technicians, and pharmacies; for establishing regulations for pharmacy practice; and for disciplining licensees and registrants.
“ URAC ”
means the Utilization Review Accreditation Commission, which is a review accreditation commission which offers health organizations an
opportunity to have trained reviewers examine their operations and publicly ensure they are delivering care in a manner consistent with
national standards.
3
Table of Contents
PART
I
Item
1. Business.
Introduction
The
information included in this Report on Form 10-K should be read in conjunction with the consolidated financial statements and related
notes in “ Item 8. Financial Statements and Supplemental Data ” of this Report.
Our
logo and some of our trademarks and tradenames are used in this Report. This Report also includes trademarks, tradenames and service
marks that are the property of others. Solely for convenience, trademarks, tradenames, and service marks referred to in this Report may
appear without the ®, ™ and SM symbols. References to our trademarks, tradenames and service marks are not intended to indicate
in any way that we will not assert to the fullest extent under applicable law our rights or the rights of the applicable licensors if
any, nor that respective owners to other intellectual property rights will not assert, to the fullest extent under applicable law, their
rights thereto. We do not intend the use or display of other companies’ trademarks and trade names to imply a relationship with,
or endorsement or sponsorship of us by, any other companies.
The
market data and certain other statistical information used throughout this Report are based on independent industry publications, reports
by market research firms or other independent sources that we believe to be reliable sources. Industry publications and third-party research,
surveys and studies generally indicate that their information has been obtained from sources believed to be reliable, although they do
not guarantee the accuracy or completeness of such information; and we have not commissioned any of the market or survey data that is
presented in this Report. We are responsible for all the disclosures contained in this Report, and we believe these industry publications
and third-party research, surveys and studies are reliable. While we are not aware of any misstatements regarding any third-party information
presented in this Report, their estimates, in particular, as they relate to projections, involve numerous assumptions, are subject to
risks and uncertainties, and are subject to change based on various factors, including those discussed under the section entitled “ Item 1A. Risk Factors ”. These and other factors could cause our future performance to differ materially from our assumptions and estimates.
Some market and other data included herein, as well as the data of competitors as they relate to Mangoceuticals, Inc., is also based
on our good faith estimates.
Unless
the context requires otherwise, references to the “ Company, ” “ we, ” “ us, ” “ our, ”,
“ MangoRx ” and “ Mangoceuticals ” in this Report refer specifically to Mangoceuticals, Inc., and its
consolidated subsidiaries.
In
addition, unless the context otherwise requires and for the purposes of this report only:
●
“ Exchange
Act ” refers to the Securities Exchange Act of 1934, as amended;
●
“ SEC ”
or the “ Commission ” refers to the United States Securities and Exchange Commission; and
●
“ Securities
Act ” refers to the Securities Act of 1933, as amended.
All
dollar amounts in this Report are in U.S. dollars unless otherwise stated.
Available
Information
We
file annual, quarterly, and current reports, proxy statements and other information with the SEC. The SEC maintains an Internet site
that contains reports, proxy and information statements, and other information regarding issuers that file electronically with the SEC
like us at https://www.sec.gov and can also be accessed free of charge on the “ Investors ” section of our website
under the heading “ SEC Filings ”. Copies of documents filed by us with the SEC (including exhibits) are also available
from us without charge, upon oral or written request to our Secretary, who can be contacted at the address and telephone number set forth
on the cover page of this Report. Our website address is www.mangoceuticals.com . Our annual reports on Form 10-K, quarterly
reports on Form 10-Q, current reports on Form 8-K and amendments to those reports filed pursuant to Section 13(a) or 15(d) of the Exchange
Act of 1934 will be available through our website free of charge as soon as reasonably practical after we electronically file such material
with, or furnish it to, the SEC. The information on, or that may be accessed through, our website is not incorporated by reference into
this Report and should not be considered a part of this Report.
4
Table of Contents
Organizational
History
We
are a Texas corporation formed on October 7, 2021. Our address is 15110 N. Dallas Parkway, Suite 600, Dallas, Texas 75248. Our telephone
number is (214) 242-9619. Our website is www.MangoRX.com . We became a public reporting company on March 20, 2023, upon the effectiveness
of our Registration Statement on Form S-1 in connection with our initial public offering. Our common stock is traded on the Nasdaq Capital
Market under the symbol “ MGRX ”.
Overview
We
connect consumers to licensed healthcare professionals through our website at www.MangoRX.com , for the provision of care via telehealth
on our customer portal. We also focus on developing, marketing, and selling a variety of men’s wellness products and services via
a telemedicine platform. To date, the Company has identified men’s wellness telemedicine services and products as a growing sector
in the most recent years and especially related to the areas of erectile dysfunction (“ ED ”), hair loss, testosterone
replacement or enhancement therapies, and weight management treatments. In this regard, we have developed and are commercially marketing
a brand of ED products under the brand name “ Mango, ” a brand of hair loss products under the brand name “ Grow, ”
a brand of hormone balance and therapy products under the name “ Mojo, ” and a brand of weight loss products under the
brand name “ Slim ” (Mango, Grow, Mojo, and Slim are collectively referred to as the “ Compounded Products ”).
The
Company is also marketing and selling an U.S. Food and Drug Administration (“ FDA ”) approved form of oral testosterone
undecanoate to treat low testosterone in men and as a form of Testosterone Replacement Therapy (TRT), developed and produced by Marius
Pharmaceuticals, Inc. under the brand name “ Prime ” powered by Kyzatrex® (“ Prime” ) (Prime and
our Compounded Products collectively referred to as the “ Pharmaceutical Products ”). We 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.
The
Company, through the patent portfolio acquired as part of the Intramont IP Purchase Agreement (as further described below), is in the
process of conducting Phase II clinical trials and efficacy studies to determine the effectiveness of its patented respiratory illness
prevention technology against the likes of the influenza A virus (H1N1) and avian influenza (H5N1). The studies are anticipated to be
completed in the 2 nd quarter of 2025 which will then determine the Company’s next steps in its commercialization and
monetization efforts.
The
Company, through its Master Distribution Agreement with Propre Energie, Inc. (“Propre”)(as further described below) intends
to license certain intellectual property and patent rights from Propre relating to clinically proven, plant-based formulations targeting
hyperpigmentation, dark spots, uneven skin tone, and skin brightening through advanced solutions marketed under the brand Dermytol®
(“Dermytol”). The Company is in the process of preparing its marketing and distribution strategy for Dermytol and intends
to commence operations under this agreement in the 3 rd quarter of 2025.
All
Compounded Products are produced at and fulfilled by Epiq Scripts, LLC (“ Epiq Scripts ”), a related party compounding
pharmacy, and are available to patients on the determination of a prescribing physician that the compounded drug is necessary for the
individual patient. The Company also uses Epiq Scripts to fulfill all patient orders of Prime (as further discussed below).
Our
MangoRx branded Compounded Products currently consist of the following:
Mango
ED - This product currently includes the following three ingredients: Either Sildenafil (the active ingredient in Viagra) or
Tadalafil (the active ingredient in Cialis), and Oxytocin, all of which are used in FDA approved drugs, as well as L-Arginine, an amino
acid that is available as a dietary supplement. Epiq Scripts is currently 52% owned by Mr. Jacob D. Cohen, our Chairman and Chief Executive
Officer.
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 amounts of the three ingredients: (1) either Sildenafil
(50 milligrams (mg)) or Tadalafil (10 (mg)), Oxytocin (100 International units (IU)) and L-Arginine (50mg); and (2) either Sildenafil
(100 milligrams (mg)) or Tadalafil (20mg), Oxytocin (100IU) and L-Arginine (50mg).
5
Table of Contents
Our
Mango ED product has not been, and will not be, approved by the FDA and instead we 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 (“ FFDCA Act ”),
as discussed below. 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 are publicly disclosed, this product formula can
be replicated by other companies.
We
are not aware of any clinical studies involving (i) administration of Tadalafil or Sildenafil sublingually at the doses we provide patients,
or (ii) compounding of Tadalafil or Sildenafil, Oxytocin, and L-arginine to treat ED, similar to our Mango ED products. We are, however,
aware of other companies that are currently selling oral disintegrating tablets for ED, including those using a combination of Tadalafil
(the active ingredient in Cialis) and Sildenafil (the active ingredient in Viagra). 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. Clinical studies of intranasal Oxytocin have also found that
Oxytocin is generally safe and well-tolerated.
‘GROW’
by MangoRx - Mango GROW currently includes the following four ingredients - (1) Minoxidil (the active ingredient in Rogaine®)
and (2) Finasteride (the active ingredient in Propecia), each of which is used in FDA approved drugs, as well as (3) Vitamin D3 and (4)
Biotin, which are available as dietary supplements. However, the fact that Minoxidil and Finasteride are used in FDA approved drugs,
and that Vitamin D3 and Biotin, are available as a dietary supplement, does not mean that these ingredients will prove safe when combined
into a single formulation to attempt to treat hair growth. Mango GROW is encapsulated in convenient chewable, mint-flavored rapid dissolve
tablets (“ RDT ”).
We
currently offer one dosage level of our Mango GROW product and anticipate doctors prescribing Mango GROW based on the needs and medical
history of the patient. Our Mango GROW product currently includes the following amounts of the four ingredients: (1) Minoxidil (2.5mg),
(2) Finasteride (1mg), (3) Vitamin D3 (2000IU) and (4) Biotin (1mg). Our Mango GROW product has not been, and will not be, approved by
the FDA and instead we produce and sell our Mango GROW product and plan to produce and sell future pharmaceutical products, under an
exemption provided by Section 503A of the FFDCA Act.
We
are not aware of any clinical studies involving the administration of Minoxidil and Finasteride sublingually at the dose we provide patients,
or the compounding of Minoxidil, Finasteride, Vitamin D3, and Biotin, to treat hair growth, as is contemplated by our Mango GROW product.
We are, however, aware of other companies that are currently selling oral tablets for hair growth, including those using a combination
of Minoxidil and Finasteride. Additionally, because our Mango GROW product is being specially compounded for the customer by a pharmacist
with a physician’s prescription and because the ingredients for our Mango GROW product are publicly disclosed, this product formula
can be replicated by other companies.
‘SLIM’
by MangoRx - SLIM currently includes the following two ingredients - (1) Vitamin B6, which is available as dietary supplement,
and (2) Semaglutide, the active ingredient used in an FDA approved drug. However, the fact that Semaglutide is used in an FDA approved
drug, and that Vitamin B6 is available as a dietary supplement, does not mean that these ingredients will prove safe when combined into
a single formulation to attempt to assist with weight loss or weight management. SLIM is encapsulated in convenient chewable, mint-flavored
RDT.
We
currently offer four dosage levels of our SLIM product and anticipate doctors prescribing SLIM based on their needs and medical history
of the patient. Our SLIM product currently includes the (1) Vitamin B6 (10mg), and (2) Semaglutide, in either 0.5mg, 1.0mg, 1.5mg or
2.0mg variations, which amount is based on the prescribing practitioner. Our SLIM product has not been, and will not be, approved by
the FDA and instead we produce and sell our SLIM product and plan to produce and sell future pharmaceutical products, under an exemption
provided by Section 503A of the FFDCA Act.
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We
are not aware of any clinical studies involving the administration of Semaglutide as a RDT at the dose we provide patients, or the compounding
of Semaglutide and Vitamin B6, to treat weight loss or weight management, as is contemplated by our SLIM product.
‘MOJO’
by MangoRx - This product is produced at our related party compounding pharmacy and is available to patients on the determination
of a prescribing physician that the compounded drug is necessary for the individual patient. MOJO currently includes the following three
ingredients - (1) Dehydroepiandrosterone (“ DHEA ”), which is available as dietary supplement, (2) Pregnenolone, which
is available as a dietary supplement, and (3) Enclomiphene Citrate, one of the active ingredients in Clomid and is used in an FDA approved
drug. However, the fact that Enclomiphene Citrate is used in an FDA approved drug, and that DHEA and Pregnenolone are available as a
dietary supplement, does not mean that these ingredients will prove safe when combined into a single formulation to attempt to treat
hormone imbalances. MOJO is encapsulated in convenient chewable, mango-flavored RDT.
We
currently offer one dosage level of our MOJO product and anticipate doctors prescribing MOJO based on their needs and medical history
of the patient. Our MOJO product currently includes the following amounts of the three ingredients: (1) DHEA (10mg), (2) Pregnenolone
(5mg) and (3) Enclomiphene Citrate (25mg).
We
are not aware of any clinical studies involving the administration of Enclomiphene as a RDT at the dose we provide patients, or the compounding
of DHEA, Enclomiphene, and/or Pregnenolone, to treat hormone imbalances, as is contemplated by our MOJO product.
Additional
Information Regarding our Compounded Products
Because
our Compounded Products have not been, and will not be, approved by the FDA, our products have 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 funding we may raise in the near term to finance marketing and general operational expenses associated with
the sale of our Pharmaceutical Products. We launched our website in mid-November 2022.
Our
Compounded Products have been formulated as rapid dissolving tablets (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 ED 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.
‘PRIME’
by MangoRx, Powered by Kyzatrex® - ‘PRIME’, by MangoRx, powered by Kyzatrex®, a FDA-approved oral
Testosterone Replacement Therapy (TRT) product, available by prescription, that is used to treat adult men who have low or no testosterone
levels due to certain medical conditions. ‘PRIME’, by MangoRx, powered by Kyzatrex® is one of only three FDA
approved TRT treatments that is delivered orally—as opposed to the traditional, invasive, and inconvenient injection-based drug
delivery protocol. ‘PRIME’, by MangoRx, powered by Kyzatrex® delivers testosterone in a softgel capsule that
is absorbed primarily via the lymphatic system, avoiding liver toxicity. The benefits of ‘PRIME,’ powered by Kyzatrex®,
over traditional injectable TRTs include enhanced vitality, improved mood, sharper cognition, optimized physical performance, and balanced
hormonal levels at 96% efficacy by day 90, as demonstrated in Phase 3 clinical research by Marius Pharmaceuticals. With ‘PRIME,’
MangoRx is working to expand broad-based consumer access to this therapy.
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Our
Contracted Telehealth Providers
In
many states, including Texas where our principal business office is located, the corporate practice of medicine doctrine prohibits corporations
from practicing medicine and from employing physicians to provide professional medical services. Many states that recognize this doctrine
also prohibit physicians from agreeing to share the fees they receive for professional services with unlicensed entities or individuals,
a practice that is commonly known as “ fee splitting. ” The requirements for compliance with any applicable corporate
practice of medicine and fee splitting restrictions vary among the states. In Texas, for example, there is no statute that expressly
prohibits fee splitting, but the corporate practice of medicine doctrine has been interpreted to prohibit physicians from ceding control
over their fee structures to corporate entities or giving a substantial portion of the fees received to corporate entities.
In
order to comply with corporate practice of medicine and fee splitting restrictions, we do not employ or directly contract with individual
physicians or physician groups, nor do we control their medical decision-making or charges. Rather, the Company has entered into a variety
of physician services agreements (the “ Physicians Agreements ”) with BrighterMD, LLC doing business as Doctegrity (“ Doctegrity ”),
LocumTele, and Locum Tenens USA (collectively, the “ Telemedicine Providers ”), all of which counterparties have agreed
to make available to us, healthcare professionals, to allow them to provide clinical services directly to our future customers via telehealth.
We have integrated these healthcare professionals to allow for telehealth consultations and related services on our Mangoceuticals platform
which has been developed and is complete. This platform is the backbone of our business as it connects consumers with both the medical
provider and the pharmacy for fulfillment. It is also the system that we will use to create marketing funnels for outgoing marketing,
customer management and support, and analytics for future sales.
Through
our Physician Agreements, the healthcare professionals are responsible for the practice of medicine and control of the clinical decision-making.
After
a patient visits our website and submits a request for a consultation with a health care professional, our Telemedicine Providers communicate
the patient’s information to one of their affiliated physicians. The Telemedicine Providers and their physicians are responsible
for conducting the telehealth consultation and any ongoing communication with the patient in accordance with applicable laws. The physicians
make a determination, in their sole discretion, as to whether or not to prescribe our Pharmaceutical Products to potential customers.
If the physicians prescribe our Pharmaceutical Products, then the customers pay us for our products. In turn, Epiq Scripts, LLC, pursuant
to the Master Services Agreement discussed below, is provided information on the customer and compounding of our product, compound the
product, and ship the product to customers using packaging and shipping materials which we supply.
We
pay the Telemedicine Providers for each physician visit conducted in response to request made by a patient on our website, regardless
of whether the physician prescribes our product to the patient. The fee we pay the Telemedicine Providers is fixed, set in advance and
is negotiated at arms’ length after comparing the prices offered by similar services. We are not a party to any contracts between
the Telemedicine Providers and any health professionals or physician groups and do not control how the Telemedicine Providers reimburse
these providers.
Although
our arrangement with the Telemedicine Providers, as summarized above, is structured to comply with applicable laws, including those restricting
the corporate practice of medicine and fee splitting, there may be a risk that a state agency, now or in the future as these laws (and
interpretations of them) evolve, would conclude that the arrangement and fee structure between the Telemedicine Providers and their contracted
physicians and/or our agreements with the Telemedicine Providers violate the corporate practice of medicine doctrine and fee splitting
restrictions in Texas or in another state where a patient who uses our Mangoceuticals platform is located.
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The
Telemedicine Providers’ physicians are tasked with determining whether patients seeking our Pharmaceutical Products are eligible
to be prescribed our Pharmaceutical Products, with the sole purpose of the telemedicine engagement being for the determination, in the
physician’s sole judgment, of whether the patient is qualified to obtain a prescription for the Pharmaceutical Products. The Telemedicine
Providers’ physicians are required to electronically send prescriptions to Epiq Scripts (the Company’s designated and accredited
pharmacy partner), which financial relationship is required to be disclosed in writing to the patient via the Terms and Conditions listed
on the Company’s website, including informed consent, and also informing the patient that the prescription is sent to the Company’s
designated pharmacy partner. The Telemedicine Providers’ physicians are only able to prescribe our Pharmaceutical Products to patients
seeking help for the treatment which the specific product provides (for example, Mango ED for treatment for ED and GROW for treatment
hair loss) through our customer portal.
Our
Related Party Pharmacy
As
discussed in greater detail below under “ —Material Agreements—Master Services Agreement with Epiq Scripts ”
we have entered into an exclusive Master Services Agreement and statement of work with Epiq Scripts, LLC, for its specialty compounding
and packaging capabilities, fulfillment, and distribution of certain prescription products available through our platform. These prescription
products include our Pharmaceutical Products. Epiq Scripts is a related party because it was 51%-owned by American International Holdings
Corp (“ American International ”) at the time of our entry into the Master Services Agreement and is currently 52% owned
by Mr. Jacob D. Cohen, our Chairman and Chief Executive Officer. Mr. Cohen, our Chairman and Chief Executive Officer, also served as
the Chief Executive Officer and a director of, and had voting control over, American International at the time of the entry into the
Master Services Agreement. Our company was previously wholly-owned by American International until April 16, 2022, when control of our
company was sold to Cohen Enterprises, Inc., which entity is owned by Jacob D. Cohen, the Chairman and Chief Executive Officer of the
Company (“ Cohen Enterprises ”). Epiq Scripts was formed in January 2022 and only began compounding drugs for patients
in November 2022. On February 15, 2023, the 51% of Epiq Scripts then owned by American International was transferred to Mr. Cohen as
part of an exchange transaction, whereby Mr. Cohen agreed to cancel his preferred stock of American International, which provided him
voting control over American International, in exchange for among other assets, American International’s ownership of Epiq Scripts.
Epiq Scripts is currently 52% owned by Mr. Cohen, our Chairman and Chief Executive Officer. Additionally, Mr. Cohen has served as the
co-Manager of Epiq Scripts since January 2022.
Epiq
Scripts is currently fully licensed with the Texas State Board of Pharmacy (“ TSBP ”) and further has State Board of
Pharmacy (or its equivalent) licenses from the District of Columbia and 49 other states: Alaska, Arizona, Arkansas, California, Colorado,
Connecticut, Delaware, Florida, Georgia, Hawaii, Idaho, Illinois, Indiana, Iowa, Kansas, Kentucky, Louisiana, Maine, Maryland, Massachusetts,
Michigan, Minnesota, Mississippi, Missouri, Montana, Nebraska, Nevada, New Hampshire, New Jersey, New Mexico, New York, North Carolina,
North Dakota, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, South Dakota, Tennessee, Utah, Vermont, Virginia, Washington,
West Virginia, Wisconsin, and Wyoming, with the intent of obtaining a state license from Alabama, the remaining state by the end of the
first quarter of 2025. Epiq Scripts has obtained its National Provider Identifier (“ NPI ”)
number and is now a member of the National Council for Prescription Drug Programs (“ NCPDP ”), a standards development
organization. Additionally, Epiq Scripts has applied for the highest level of accreditation with the Utilization Review Accreditation
Commission (“ URAC ”), a Washington DC-based healthcare accrediting organization
that establishes quality standards for the entire healthcare industry . Until Epiq Scripts receives a licenses in Alabama, we are
limited to selling our Pharmaceutical Products in only the states in which Epiq Scripts holds licenses. Although Epiq Scripts is physically
located in Texas, it can ship products to customers in each state in which it holds licenses.
As
a result of the above, Epiq Scripts can currently only provide services to the Company in the District of Columbia and those 49 states
described above and the Company will be unable to sell its products to any customers in any states other than those listed above, until
Epiq Scripts is able to obtain licenses in other states and will thereafter be limited to selling products to customers only in the states
in which Epiq Scripts holds licenses.
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Our
Customer Portal
Our
customer platform connects consumers to licensed healthcare professionals through our website at www.MangoRX.com , for the provision
of care via telehealth and also provides access for customers to a licensed pharmacy for online fulfillment and distribution of certain
medications that may be prescribed as part of telehealth consultations. Additional features to this backend technology solution allow
for the creation and management of customer accounts whereby customers have the ability to login, view and make changes to their respective
accounts. These changes include, but are not limited to, reviewing order history, tracking order shipments, requesting and ordering product
refills and making other profile changes such as shipping address and payment changes. Our portal is not unique to the industry and is
not anticipated to be difficult or costly to replicate or replace.
The
backend technology solution also houses and manages all customer data allowing the Company with additional key functionality, including
but not limited to, providing customer service and support and data analytics for various marketing initiatives and reporting functions.
We
do not anticipate selling any third-party products via our portal.
Our
Growth Strategy
Utilize
a variety of marketing channels using data analytics to attract customers
We
currently market and advertise our Pharmaceutical Products on a variety of advertising mediums including, but not limited to, social
media, online search websites, podcasts, television, radio, out-of-home, and other media channels, in compliance with applicable FDA
rules and requirements. However, due to such rules and requirements, we are extremely limited in the content of the claims and promotional
statements that we are able to make regarding our products under applicable FDA regulations. We believe advertising in a diversified
set of media channels is important to prevent overreliance on any single channel and to maximize the exposure of our brand to our desired
customers. We also reach customers through our own social media accounts, press coverage and public relations, internally developed educational
and lifestyle content, and through engagement of social media influencers, hired and paid celebrities and talent, and physical brand
advertising campaigns, in each case funding permitting, and in each case subject to applicable rules and regulations, which are expected
to significantly limit the content of such marketing materials. We believe that this overall strategy will drive significant customer
traffic to our platform, including direct type-in traffic and organic online search traffic.
We
also utilize a marketing strategy focused on analytics and data. We have designed our internal systems to measure consumer behavior,
including which types of consumers generate more revenue in their first purchase, generate more revenue over time, generate more gross
profit from their purchases, and which types of consumers are most valuable over their lifetime. We plan on measuring the effectiveness
of our marketing budgets and the rate of return we generate from our marketing campaigns. We have retained and plan on using outside
marketing and advertising firms to assist management in identifying marketing and advertising campaigns, media purchases and mediums,
and seeking to drive a sufficient rate of return from our marketing and advertising budgets.
Invest
in our telemedicine platform to enable sales throughout the United States
We
utilize both a synchronous and asynchronous approach through our telemedicine platform, connecting customers through our platform and
contracted physicians and pharmacy. An asynchronous visit allows a physician to verify the patient’s identity, demographics and
collect the medical history online without needing to physically see or speak to the patient. A synchronous visit requires the doctor
to either speak directly to the patient and/or see the patient either via video conference or in person. As discussed above, we initially
are focusing our sales in the District of Columbia and 49 states where our related party pharmacy is licensed, with the goal of eventually
undertaking sales across all 50 states, pending licensing approvals of our related party pharmacy.
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Provide
subscription plans for recurring revenue and introduction of new products
We
provide our customers with an option to purchase our Pharmaceutical Products on a subscription basis, where and when applicable. Subscription
plans provide an easy and convenient way for customers to get ongoing treatment while simultaneously providing the Company with predictability
through a recurring revenue stream.
For
subscription plans, customers are able to select a desired timeframe in which to receive products, which range from once every month
to once every six months. The customer will then be billed on a recurring basis based on the selected timeframe and specified quantity
of product, which is shipped after each billing from our contracted pharmacy (Epiq Scripts). Customers are able to cancel subscriptions
in between billing periods to stop receiving additional products and reactivate subscriptions. Our integrated technology platform serves
customers from customer discovery, through the purchase of products on our website, to connecting customers with medical providers for
telehealth consultations (through our contracted physician network), to the fulfillment and delivery of orders (through our contracted
pharmacy), and finally through ongoing management by medical providers (also through our contracted physician network). We believe our
platform provides us cost advantages and efficiencies to offer customers affordable prices and to generate increased revenues over time.
In
addition to our Pharmaceutical Products, we intend to launch new products over time and offer additional subscription-based offerings
which we hope will result in growth in revenue through recurring revenue streams.
Parent
Subsidiary Contribution Agreement
On
December 13, 2024, the Company, entered into a Parent Subsidiary Contribution Agreement with Mango & Peaches Corp., a Texas corporation
(“ Mango & Peaches ”), a then recently formed wholly-owned subsidiary of the Company (the “ Contribution
Agreement ”). Pursuant to the Contribution Agreement, the Company contributed substantially all of its assets, including ownership
of: (a) its 98% ownership of MangoRx Mexico S.A. de C.V., a Mexican Stock Company; and (b) its 100% ownership of MangoRx UK Limited,
a company incorporated under the laws of the United Kingdom (collectively, the “ Contributed Assets ”), to Mango &
Peaches, in order to restructure the ownership and operations of the Company, better segregate such operations and liabilities and provided
for the issuance of a portion of the capital of Mango & Peaches to Mr. Jacob Cohen, the Chief Executive Officer of the Company, as
additional consideration to Mr. Cohen, as discussed in greater detail below under “ Item 11. Executive Compensation ”—“ Employment
and Consulting Agreements ”— “ Jacob D. Cohen, Chief Executive Officer ”, pursuant to which the Company
agreed to issue Mr. Cohen (a) 1,700,000 shares of the common stock of Mango & Peaches (representing 25.4% of Mango and Peaches’
then outstanding shares of common stock)(the “ Mango & Peaches Common Shares ”); and (b) 100 shares Series A Super
Majority Voting Preferred Stock of Mango & Peaches, discussed in greater detail below (the “ Mango & Peaches Series A
Shares ”), which issuances are subject to shareholder approval, which shareholder approval the Company expects to solicit from
shareholders in the near future.
In
consideration for the transfer of the assets, the Company received 4,999,999 shares of Mango & Peaches’ common stock, bringing
its ownership to 5,000,000 shares of common stock of Mango & Peaches upon the closing of the Contribution Agreement.
Pursuant
to the Contribution Agreement, Mango & Peaches assumed all of the liabilities of the Company relating to the Contributed Assets contributed,
but none of the other liabilities of the Company and the Company agreed to indemnify Mango & Peaches against any damages relating
to a breach of any representation or warranty of the Company in the Contribution Agreement, or any claim relating to the Contributed
Assets, before the Contribution Effective Date; and Mango & Peaches agreed to indemnify the Company against any damages relating
to a breach of any representation or warranty of Mango & Peaches in the Contribution Agreement, or any claim relating to the Contributed
Assets, after the Contribution Effective Date. The Contribution Agreement and the contribution and assumption provided for therein was
effective December 15, 2024 (the “ Contribution Effective Date ”).
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On
January 9, 2025, Mango & Peaches filed a Certificate of Designations of Mango & Peaches Corp., establishing the designations,
preferences, limitations, and relative rights of its Series A Super Majority Voting Preferred Stock (the “ Series A Preferred
Stock ”), with the Secretary of State of Texas, which was filed by the Texas Secretary of State on January 15, 2025, effective
January 9, 2025 (the “ Series A Designation ”). The Series A Designation designated 100 shares of Series A Preferred
Stock, the rights of which are discussed in greater detail below:
The
Series A Designation provides for the Series A Preferred Stock to have the following rights: No dividend, liquidation, redemption or
conversion rights; voting rights providing that for so long as any shares of Series A Preferred Stock remain issued and outstanding,
the holders thereof, voting separately as a class, have the right to vote on all shareholder matters (including, but not limited to at
every meeting of the stockholders of Mango & Peaches and upon any action taken by stockholders of Mango & Peaches with or without
a meeting) equal to fifty-one percent (51%) of the total vote (the “ Total Series A Vote ” and the “ Voting
Rights ”), and that so long as Series A Preferred Stock is outstanding, Mango & Peaches shall not, without the affirmative
vote of the holders of at least 66-2/3% of all outstanding shares of Series A Preferred Stock, voting separately as a class (i) amend,
alter or repeal any provision of the Certificate of Formation or the Bylaws of Mango & Peaches so as to adversely affect the designations,
preferences, limitations and relative rights of the Series A Preferred Stock, (ii) effect any reclassification of the Series A Preferred
Stock, (iii) designate any additional series of preferred stock, the designation of which adversely effects the rights, privileges, preferences
or limitations of the Series A Preferred Stock; or (iv) amend, alter or repeal any provision of the Series A Designation (except in connection
with certain non-material technical amendments). Additionally, subject to the rights of series of preferred stock which may from time
to time come into existence, so long as any shares of Series A Preferred Stock are outstanding, Mango & Peaches cannot without first
obtaining the approval (by written consent, as provided by law) of the holders of a majority of the then outstanding shares of Series
A Preferred Stock, voting together as a class: (a) issue any additional shares of Series A Preferred Stock after the original issuance
of shares of Series A Preferred Stock; (b) increase or decrease the total number of authorized or designated shares of Series A Preferred
Stock; (c) effect an exchange, reclassification, or cancellation of all or a part of the Series A Preferred Stock; (d) effect an exchange,
or create a right of exchange, of all or part of the shares of another class of shares into shares of Series A Preferred Stock; or (e)
alter or change the rights, preferences or privileges of the shares of Series A Preferred Stock so as to affect adversely the shares
of such series, including the rights set forth in the Series A Designation.
As
a result of the issuance of the Mango & Peaches Common Shares and Mango & Peaches Series A Shares, Mr. Cohen will obtain majority
control over substantially all of the assets and operations of the Company at the time of the entry into the Contribution Agreement,
which following the Contribution Effective Date, are held by Mango & Peaches, including the right to vote 75.5% of Mango & Peaches
outstanding voting shares as result of his ownership of Mango & Peaches Common Shares and the Mango & Peaches Series A Shares,
which will provide him the right to approve any merger or consolidation of Mango & Peaches and/or any amendment to the Certificate
of Formation of Mango & Peaches.
Additionally,
Mr. Cohen, pursuant to the terms of his Employment Agreement, as amended, discussed in greater detail below under “ Item 11.
Executive Compensation ”—“ Employment and Consulting Agreements ”— “ Jacob D. Cohen, Chief
Executive Officer ”, has the right to earn up to $10 million bonus (the “ Mango & Peaches Bonus ”), which
is convertible at his option, at a conversion price of $0.50 per share, into up to 20,000,000 shares of common stock of Mango & Peaches.
In the event the full amount of the Mango & Peaches Bonus, vests to Mr. Cohen and he converts such entire Mango & Peaches Bonus
into 20,000,000 Mango & Peaches Bonus Shares pursuant to the conversion terms thereof, he will own 81.3% of Mango & Peaches outstanding
common stock (not factoring in any other issuances), and 92.8% of Mango & Peaches’ outstanding voting stock (as a result of
the ownership of the Mango & Peaches Series A Shares and not factoring in any future issuances). There is no assurance that any of
the milestones will be reached by Mango & Peaches and/or that any portion of the Mango & Peaches Bonus will vest to Mr. Cohen
or that any Mango & Peaches Bonus Shares will be issued to Mr. Cohen.
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Material
Agreements
Master
Services Agreement with Epiq Scripts
On
September 1, 2022, and effective on August 30, 2022, we entered into a Master Services Agreement with Epiq Scripts, which at the time
was 51%-owned by American International. Mr. Cohen, our Chairman and Chief Executive Officer, served as the Chief Executive Officer and
a director of, and had voting control over, American International at the time of the entry into the Master Services Agreement, and currently
serves on the Board of Directors of American International. The Company was wholly-owned by American International until June 16, 2022,
when control of the Company was sold to Cohen Enterprises, which is owned by Mr. Cohen. Epiq Scripts was formed in January 2022 and only
began compounding drugs for patients in November 2022. On February 15, 2023, the 51% of Epiq Scripts then owned by American International
was transferred to Mr. Cohen as part of an exchange transaction, whereby Mr. Cohen agreed to cancel his preferred stock of American International,
which provided him voting control over American International, in exchange for among other assets, American International’s ownership
of Epiq Scripts. Epiq Scripts is currently 52% owned by Mr. Cohen, our Chairman and Chief Executive Officer. Additionally, Mr. Cohen
has served as the co-Manager of Epiq Scripts since January 2022.
Pursuant
to the Master Services Agreement and a related statement of work (“ SOW ”), Epiq Scripts agreed to provide pharmacy
and related services to the Company, the Company agreed to exclusively use Epiq Scripts as the provider of the Services (defined below)
during the term of the agreement, so long as Epiq Scripts complies with the terms of the Master Services Agreement. The agreement also
includes a 30 day right of first refusal for Epiq Scripts to provide pharmacy services for any new product that Mango may introduce during
the term of the agreement.
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Pursuant
to the SOW, Epiq Scripts agreed to provide for the online fulfillment, specialty compounding, packaging, shipping, dispensing and distribution
(collectively, the “ Services ”) of products sold exclusively via our website that may be prescribed as part of a telehealth
consultation on our platform. Epiq Scripts also agreed to provide mail service pharmacy services to us on an exclusive basis during the
term of the SOW.
We
agreed to provide Epiq Scripts with all custom packaging materials, including but not limited to, individual sachet and/or blister packaging
materials, outer box packaging, and any custom inserts and/or marketing information to accompany the prescription shipment, if any and
to provide Epiq Scripts with quarterly sales forecasts to ensure Epiq Scripts has enough packaging materials on hand to cover a 90 day
period. We agreed to pay for all direct shipping, delivery and related courier costs and to provide Epiq Scripts with direct access to
any online accounts to access and generate shipping labels for the fulfillment and delivery of our products.
The
SOW has a term through December 31, 2025, automatically renewable thereafter for successive one-year terms unless either party terminates
the agreement at least 90 days before renewal thereof and the SOW is subject to the same termination rights of the parties as set forth
in the Master Services Agreement (discussed below).
Pursuant
to the SOW, we agreed to pay Epiq Scripts certain fixed rate fees for prescription fulfillment, processing and packaging (per prescription)
and drug compounding (per pill), provided the per pill rate is reduced upon us exceeding 3,500 product packages per month.
Under
the Master Services Agreement, we are solely responsible for billing and collecting funds from our customers and Epiq Scripts is paid
out of funds that we actually collect.
The
Master Services Agreement has a term of five years, automatically renewable to additional one-year terms thereafter unless either party
provides the other notice of termination at least 90 days prior to the date of automatic renewal. The Master Services Agreement can be
terminated (i) upon breach of the agreement by the other party, subject to a 90-day cure right, (ii) if a party enters into bankruptcy
or fails to pay its debts as they become due, or (iii) if Epiq Scripts becomes unable to perform the services covered by the Master Services
Agreement and any statements of work associated therewith.
Payments
under the Master Services Agreement are due within 15 days after the end of each month during which collections are received. The Master
Services Agreement contains customary confidentiality obligations, record retention provisions, audit rights, and representations and
warranties of the parties. Each party to the Master Services Agreement agreed to indemnify, defend, and hold harmless the other and the
other party’s officers, directors, shareholders, employees, and agents from and against any and all nonparty claims, or actions
for damages, liabilities (including strict liability), penalties, costs and expenses (including reasonable legal fees, expenses and costs)
to the proportionate extent caused by (1) the negligence or willful misconduct of the indemnitor or any of its employees or agents in
connection with the performance of the agreement, or (2) any breach of any representation, warranty or covenant under the agreement by
the indemnitor or any of its employees or agents. Additionally, the parties agreed that neither party will be liable to the other for
special, incidental, or exemplary damages, subject to certain limited exceptions. The Master Services Agreement does not address product
liability claims or assign any rights of indemnification or contribution in connection therewith.
We
paid Epiq Scripts a total of $60,000 upon our entry into the Master Services Agreement, comprising $45,000 as a one-time non-refundable
technology systems setup and implementation fee and $15,000 as an upfront retainer to be credited towards the future provision of pharmacy
and related services as outlined and detailed in the Master Services Agreement and SOW. All costs related to the pharmacy services provided
by Epiq Scripts are listed as related party costs of revenues on our statement of operations.
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Epiq
Scripts has filed with the URAC to obtain its pharmacy accreditation and obtained its first state license in the State of Texas in February
2022. Epiq Scripts has State Board of Pharmacy (or its equivalent) licenses to operate in the District of Columbia and the following
49 states: Alaska, Arizona, Arkansas, California, Colorado, Connecticut, Delaware, Florida, Georgia, Hawaii, Idaho, Illinois, Indiana,
Iowa, Kansas, Kentucky, Louisiana, Maine, Maryland, Massachusetts, Michigan, Minnesota, Mississippi, Missouri, Montana, Nebraska, Nevada,
New Hampshire, New Jersey, New Mexico, New York, North Carolina, North Dakota, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South
Carolina, South Dakota, Tennessee, Texas, Utah, Vermont, Virginia, Washington, West Virginia, Wisconsin, and Wyoming and plans to eventually
obtain licenses in all 50 states by the end of the first quarter of 2025, with some state licenses easier to obtain and quicker to obtain
than others.
As
a result of the above, Epiq Scripts can currently only provide the Services to the Company in the District of Columbia and 49 states
described above, and the Company will be unable to sell its products to any customers in any states other than those named above, until
Epiq Scripts is able to obtain licenses in other states and will thereafter be limited to selling products to customers only in the states
in which Epiq Scripts holds a license.
On
September 15, 2023, we entered into a First Addendum to Master Services Agreement (“ MSA ”) with Epiq Scripts (the “ First
Amendment ”).
Pursuant
to the First Amendment, the parties agreed to amend the MSA to include certain Right of first negotiation rights and right of first refusal
rights (each as discussed below). Additionally, the First Amendment provides for certain rights to Epiq Scripts in the event that the
Company seeks to obtain pharmaceutical services in connection with certain Company products (collectively, “ Pharmaceutical Services ”)
in jurisdictions other than the United States, including, without limitation, Mexico and the United Kingdom, where Epiq Scripts does
not currently maintain licenses or permits (“ Future Jurisdictions ”, which shall also include, to the extent applicable,
any state in the United States in which Epiq Scripts does not then hold required permits or licenses for the provision of the Pharmaceutical
Services) and/or to terminate Epiq Scripts’ rights to provide exclusive Pharmaceutical Services in any current state of the United
States or Future Jurisdiction where Epiq Scripts may then be providing Pharmaceutical Services to the Company (each a “ Current
Jurisdiction” ). To date, there have been no fees paid to Epiq Scripts pursuant to this agreement.
Specifically,
the parties agreed in the First Amendment that should the Company decide to transfer any services provided by Epiq Scripts in a Current
Jurisdiction to another pharmaceutical service provider (“ Transferred Services ”), the Company will be required to
pay Epiq Scripts a fee of 1% of the total gross sales of all Prescription Products (defined below) by the Company resulting from the
Transferred Services in the Current Jurisdiction, for a period of the lesser of (a) five (5) years from the date the Company transferred
the Transferred Services; and (b) through the end of the term of the MSA (including where applicable, any renewal term)(the “ Non-Use
Fee ”). The Non-Use Fee is payable monthly in arrears, for calendar quarters, by the 15th day following the end of each calendar
quarter. “ Prescription Products ” means Products (as defined in the MSA) sold by the Company which must be prescribed
by a medical doctor.
Notwithstanding
the above, the Non-Use Fee shall not apply, and the Company shall not be obligated to pay any Non-Use Fee (a) in the event that the Transferred
Services are provided directly by the Company or a majority-owned subsidiary of the Company; (b) in the event the Company decides to
enter into an agreement with another pharmaceutical service provider to provide Pharmaceutical Services in a Future Jurisdiction; or
(c) in connection with any services provided by any parties in any Future Jurisdictions.
The
First Amendment also provides that until the fifth anniversary of the First Amendment, the Company shall notify Epiq Scripts in writing
of any plans to (a) expand its need for pharmacy services outside of those contemplated by the MSA; (b) expand its need for pharmacy
services into a new jurisdiction which Epiq Scripts does not then operate in (including, but not limited to new countries); or (c) begin
providing pharmacy services internally (either through organic growth or acquisition). Thereafter Epiq Scripts has the right to provide
the Company written notice of its intention to provide such services (as described in (a) or (b) above, whereafter the Company is required
to discuss and negotiate such services in good faith with Epiq Scripts for a period of not less than 15 days). Otherwise, in the event
of the occurrence of an event discussed in (c) above, the Company is required to discuss the possibility of Epiq Scripts either co-operating
the pharmacy or providing management services to the Company in good faith for 15 days. In the event after such 15 day period, the Company
and Epiq Scripts cannot come to a mutually agreeable agreement, the Company is under no further obligation regarding the matter set forth
in the notice provided to Epiq Scripts.
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Finally,
the First Amendment includes a requirement whereby if Epiq Scripts receives notice of any proposed fundamental transaction involving
Epiq Scripts or its assets, including any agreement, arrangement, offer or proposal (including a letter of intent, term sheet, form of
definitive agreement or definitive agreement) for an asset sale or acquisition, merger, acquisition or sale of securities, or redemption
or repurchase of securities, Epiq Scripts must provide the Company notice of such offer within three days, after which receipt the Company
will have the right of first refusal for 30 days to become the purchaser in connection with the notified transaction, on the terms, and
subject to the conditions, set forth in such notified offer and pursuant to the conditions of the First Amendment.
On
January 30, 2025, the Company, with the approval of the disinterested members of the Board of Directors and the Company’s Audit
Committee, made up of independent members of the Board of Directors, entered into two Assignment, Assumption and Novation Agreements
(the “ Epiq Scripts Assignments ”) with Epiq Scripts. Pursuant to the Epiq Scripts Assignments, the Company assigned
all of its rights under (1) the MSA, as amended; and (2) the Consulting Agreement with Epiq Scripts discussed below, to Mango & Peaches,
Mango & Peaches agreed to take responsibility for all obligations thereunder, effective as of the assignment date, and Epiq Scripts
agreed to novate the responsibility of the Company thereunder, effective as of the assignment date. Additionally, we agreed to indemnify
Mango & Peaches for any liability under such agreements prior to the assignment date and Mango & Peaches agreed to indemnify
us against any liability under such agreements after the assignment date.
Consulting
Agreement with Epiq Scripts
On
September 15, 2023, we entered into a Consulting Agreement (the “ Consulting Agreement ”) with Epiq Scripts. Pursuant
to the Consulting Agreement, Epiq Scripts agreed to provide pharmacy consulting services in connection with the Company’s global
expansion efforts, and as reasonably requested by the Company, during the term of the agreement, which is for five years, unless otherwise
earlier terminated (a) due to breach of the agreement by either party and the failure to cure such breach 30 days after written notice
thereof; (b) the mutual agreement of the parties; or (c) the date that Epiq Scripts provides the Company written notice of termination,
which may be at any time and for any reason.
In
consideration for agreeing to provide the services under the agreement, the Company agreed to pay Epiq Scripts (1) a one-time payment
of $65,000, payable within ten days of the entry into the agreement, which was timely paid; and (2) a set fee, payable for each prescription
drug pill sold by the Company for cash, to the extent such pill must be prescribed by a medical doctor, or sold through retail pharmacies
over the counter, in jurisdictions where a doctor’s prescription is not required for the sale of such drugs, and sold in a Territory
(defined below), which consideration per pill decreases each year that the agreement is in effect, and is only payable for the first
five years of the agreement.
The
Consulting Agreement further provides that no payments are due for the sale of any prescription pills until the First Sale.
Under
the Consulting Agreement, (a) “ Territory ” means worldwide, except for the United States, including its
territories and possessions and the District of Columbia; and (b) “ First Sale ” means the date that the first
commercial sale of prescription pills occurs in the Territory. To date, there have been no fees paid to Epiq Scripts pursuant to
this agreement.
Future
payments are also required to be offset equitably for any prescription pill sold which is later refunded, charged back, returned, or
reimbursed to a purchaser.
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The
agreement includes customary representations of the parties, confidentiality and non-solicitation provisions, rights of Epiq Scripts
to audit the sales of prescription pills, subject to certain limitations and requirements, and the requirement that the Company reimburse
certain expenses of Epiq Scripts, subject to certain limitations and pre-approvals.
Marketing
Agreement
On
December 10, 2023, the Company entered into a Marketing Agreement with Marius Pharmaceuticals, LLC (“ Marius ”) allowing
the Company the use of the trademark “ Kyzatrex® ” oral testosterone undecanoate softgel capsules, for the purposes
of branding, packaging, marketing, and selling Kyzatrex® on the Company’s website, and to be sold via its telehealth platform
at www.MangoRx.com . Pursuant to the Marketing Agreement, Marius granted the Company a non-exclusive, non-transferable, royalty-free
license to use the Marius Marks in the United States, for the purpose discussed above.
The
Marius Agreement contains customary confidentiality and indemnification provisions and has an initial term of two years, automatically
renewable thereafter for successive one year terms unless otherwise terminated (a) by Marius if the Company does not have at least 2,500
monthly customers of “ Kyzatrex® ” oral testosterone undecanoate softgel capsules at least 30 days prior to the
end of the initial term, (b) by either party for cause in connection with a material breach that has not been cured within 30 business
days of written notice thereof provided by the non-breaching party to the breaching party, or (c) by Marius in its sole discretion without
cause by providing at least 60 days’ prior written notice to the Company. Marius may also terminate the agreement with written
notice to the Company if the Company has not met at least 30% of the Minimum Subscribers within six months of the product launch date
on the Company’s website.
Within
30 days of the date the Marius Agreement is terminated (or on the date of termination, which cannot occur earlier than 60 days after
notice of termination is provided, if Marius terminates the Marius Agreement for convenience), we are required to stop and cease all
use of the Marius Marks and are required to remove all references to the Marius Marks from our advertising/promotional materials, and
signage.
During
the term of the Marius Agreement and for a period of 12 months thereafter, we agreed to not create, publish or broadcast any advertisement
or otherwise promote or market any other product containing testosterone undecanoate.
Pursuant
to the Marius Agreement, and in consideration of the license granted thereunder, the Company issued Marius 6,667 shares of the Company’s
restricted common stock (the “ Marius Shares ”) which are fully earned upon entry into the agreement. The Marius Shares
were valued at $10.20 per share for a total of $68,000.
Master
Distribution Agreements
ISFLST
On
July 9, 2024, we entered into a Master Distribution Agreement with ISFLST, Inc. (“ ISFLST ”) dated July 2, 2024 (the
“ Distribution Agreement ”). Pursuant to the Distribution Agreement, we agreed to sell, and ISFLST agreed to purchase,
certain of our products, including our MangoRx Grow and Mango ED products (collectively, the “ Products ”), for distribution
and resale by ISFLST during the term of the agreement.
Pursuant
to the Distribution Agreement, ISFLST agreed to use commercially reasonable efforts to sell and promote the sale of the Products in Asia
Pacific and Latin America (excluding Mexico), and we provided ISFLST a non-exclusive, non-transferable license to market and sell the
Products, and grant sub-licenses (subject to certain pre-requisites and limitations described in greater detail in the Distribution Agreement)
to sell the Products, in the Market. We also agreed, subject to certain future mutually agreed milestones that ISFLST could earn exclusive
rights to market the Products in the applicable “ Market ”.
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The
Distribution Agreement has a term of three years and is automatically renewable thereafter for three additional one year terms, unless
either party provides the other notice of non-renewal at least 90 days prior to an automatic renewal date. The agreement may also be
terminated by the non-breaching party upon the material breach of the agreement by the counterparty and failure to cure such breach after
90 days written notice, or upon insolvency.
The
Distribution Agreement includes customary confidentiality requirements of the parties, representations and warranties of the parties,
mutual indemnification rights, disclaimers of warranties and limitation of liabilities, and force majeure provisions.
The
Distribution Agreement also includes a non-solicitation obligation of ISFLST, which applies during the term of the agreement and for
two years thereafter.
All
pricing information will be mutually agreed to by the parties and set forth in a separate purchase order, subject to availability and
volume requirements.
Propre
On
January 30, 2025, the Company entered into a Master Distribution Agreement (the “ MDA ”), with Propre Energie Inc. Pursuant
to the MDA, the Company will license certain intellectual property and patent rights from Propre relating to clinically proven, plant-based
formulations targeting hyperpigmentation, dark spots, uneven skin tone, and skin brightening through advanced solutions marketed under
the brand Dermytol®.
We
agreed pursuant to the MDA to pay Propre 650,000 shares of the Company’s restricted common stock (the “ Propre Shares ”)
and 1% of the gross sales revenue we generate during the term of the MDA. The MDA has a term of three years, renewable thereafter for
up to three additional one year terms, provided that neither party provides the other notice of termination at least 90 days prior to
the renewal date, provided that Propre has a right of termination in the event we sell substantially all of our assets or a majority
interest in the Company during the term and either party may terminate the agreement if the other party breaches the MDA and fails to
cure such breach within 90 days or becomes insolvent.
The
MDA contains customary confidentiality provisions, representations and warranties of the parties, indemnification obligations, disclaimers
and covenants, for an agreement of type and size of the MDA. The Company is still preparing its internal business plans for the marketing,
selling and distribution of Dermytol with plans to commence operations surrounding Dermytol in the 2 nd quarter of 2025.
Patent
Purchase Agreements
Intramont
Technologies
Effective
on April 24, 2024, the Company entered into a Patent Purchase Agreement (the “ Intramont IP Purchase Agreement ”), with
Intramont Technologies, Inc. (“ Intramont ”). Pursuant to the Intramont IP Purchase Agreement, we purchased certain
patents and patent applications owned by Intramont, related to prevention of infections, including the common cold, respiratory diseases,
and orally transmitted diseases such as human papillomavirus (HPV) (the “ Patents ”), in consideration for $20,000,000,
which was payable to Intramont by (a) the issuance of 980,000 shares of the Company’s then newly designated 6% Series C Convertible
Preferred Stock (the “ Series C Preferred Stock ”), with a face value of $20.00 per share, for a total value of $19,600,000
(the “ Series C Shares ”); and (b) $400,000 in cash, (i) with $200,000 payable on or before June 30, 2024, (ii) $100,000
payable on or before August 31, 2024, and (iii) $100,000 payable on or before November 30, 2024 (collectively, the “ Cash Payments ”).
The
Intramont IP Purchase Agreement, and the purchase of the Patents, closed on April 24, 2024, upon the parties entry into the Intramont
IP Purchase Agreement, and the Series C Shares were also issued on April 24, 2024. The Intramont IP Purchase Agreement included standard
representations and warranties and confidentiality and indemnification obligations of the parties, for a transaction of that type and
size. The Company purchased the Patents through its newly formed wholly-owned subsidiary, MangoRx IP Holdings, LLC, a Texas limited liability
company.
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The
Intramont IP Purchase Agreement also included a grant back license, whereby the Company provided Intramont, an irrevocable, co-exclusive,
non-transferable and non-assignable (except in the event of a change of control), non-sublicensable, worldwide, license to use the Patents
for the lives thereof (the “ Grant Back-License ”). The Grant Back-License is subject to Intramont paying the Company
a royalty of ten percent (10%) of gross worldwide sales of products sold by Intramont which utilize the Patents, beginning on April 24,
2025, and continuing until the end of the life of the last Patent (the “ Royalty Payments ”). The Royalty Payments are
to be paid to the Company on an annual basis, within 30 days after the end of the calendar year.
Finally,
the Intramont IP Purchase Agreement granted Intramont a right of first refusal, which provides that, if at any time prior to April 24,
2027, if we receive an offer to purchase the Patents and determine to accept such offer, or we determine to sell the Patents to a third
party, we are required to provide Intramont the right of first refusal to either match such offer, or negotiate different purchase terms
for the Patents.
A
total of the date of this report, $57,000 of the Cash Payments has been paid to date, provided that Intramont has not declared a default
under the IP Purchase Agreement or taken any action against the Company in connection with the failure to timely pay such Cash Payments.
On
February 11, 2025, and effective on December 31, 2024, we and Intramont entered into a letter agreement, amending the IP Purchase Agreement
(the “ Amendment Letter ”), pursuant to which Intramont has agreed that all funds paid by the Company towards the furtherance
and development of the Patents would be credited against the Cash Payments owed to Intramont and we agreed to work in good faith with
Intramont on financing, developing and commercializing the Patents.
As
a result of the Amendment Letter, a total of $306,118 remains due to Intramont in connection with the Cash Payments as of the date of
this Report, which the Company expects to pay over time, by way of expenses associated with the development of the Patents.
The
Company intends to utilize the Patents by commencing research, development, clinical trial studies and efficacy testing on a variety
of oral applications including, but not limited to, an oral dissolvable tablet (ODT), lozenge, toothpaste and/or mouthwash.
On
April 19, 2024, the Company submitted for filing to the Secretary of State of Texas, a Certificate of Designations of Mangoceuticals,
Inc. Establishing the Designations, Preferences, Limitations and Relative Rights of Its 6% Series C Convertible Cumulative Preferred
Stock (the “ Series C Designation ”), which was filed with the Secretary of State of Texas on April 23, 2024, effective
as of April 19, 2024. The Series C Designation designated 6,250,000 shares of Series C Preferred Stock. The Series C Designation provides
for the Series C Preferred Stock to have the following terms:
Dividend
Rights . From and after the issuance date of the Series C Preferred Stock, each share of Series C Preferred Stock is entitled to receive,
when, as and if authorized and declared by the Board of Directors of the Company, out of any funds legally available therefor, cumulative
dividends in an amount equal to (i) the 6% per annum on the stated value (initially $20 per share)(the “ Stated Value ”)
as of the record date for such dividend (as described in the Series C Designation), and (ii) on an as-converted basis, any dividend or
other distribution, whether paid in cash, in-kind or in other property, authorized and declared by the Board of Directors on the issued
and outstanding shares of common stock in an amount determined by assuming that the number of shares of common stock into which such
shares of Series C Preferred Stock could be converted on the applicable record date for such dividend or distribution.
Dividends
payable pursuant to (i) above are payable quarterly in arrears, if, as and when authorized and declared by the Board of Directors, or
any duly authorized committee thereof, to the extent not prohibited by law, on March 31, June 30, September 30 and December 31 of each
year (unless any such day is not a business day, in which event such dividends are payable on the next succeeding business
day, without accrual of interest thereon to the actual payment date), commencing on June 30, 2024.
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Accrued
dividends may be settled in cash, subject to applicable law, shares of common stock (valued at the closing price on the date the dividend
is due) or in-kind, by increasing the Stated Value by the amount of the quarterly dividend.
Liquidation
Preference . Upon any liquidation, dissolution or winding-up of the Company, whether voluntary or involuntary (a “ Liquidation ”),
the holders of the Series C Preferred Stock are entitled to receive out of the assets, whether capital or surplus, of the Company an
amount equal to the Stated Value (the “ Liquidation Preference ”), for each share of Series C Preferred Stock, before
any distribution or payment is made to the holders of any junior securities, but after the payment of any liquidation preference of any
holder of senior securities, including the Series B Convertible Preferred Stock, which has a preferential right to payments in liquidation,
and if the assets of the Company are insufficient to pay in full such amounts, then the entire assets to be distributed to the holders
of the Series C Preferred Stock are to be ratably distributed among the holders of the Series C Preferred Stock in accordance with the
respective amounts that would be payable on such shares if all amounts payable thereon were paid in full.
Conversion
Rights . Each holder of Series C Preferred Stock may, at its option, convert its shares of Series C Preferred Stock into that number
of shares of common stock equal to the Stated Value of such share of Series C Preferred Stock, divided by the conversion price of $10.00
per share (i.e., initially a 2-for-1 conversion ratio) (the “ Conversion Price ”), subject to adjustment for stock splits
and stock dividends, with any fractional shares rounded up to the nearest whole share.
The
Series C Designation includes a conversion limitation prohibiting any holder and their affiliates from converting the Series C Preferred
Stock into common stock in the event that upon such conversion their beneficial ownership of the Company’s common stock would exceed
4.999% (which can be increased as to any holder, to up to 9.999%, with 61 days prior written notice by such holder). The Series C Designation
also includes a general restriction prohibiting the issuance of more than 19.99% of the Company’s outstanding shares as of the
date of entry into the IP Purchase Agreement, without the Company’s stockholders approving such issuance(s) under the rules of
the Nasdaq Capital Market.
Voting
Rights . The Series C Preferred Stock have no voting rights, except in connection with the protective provisions discussed below.
Protective
Provisions . So long as any shares of Series C Preferred Stock are outstanding, the Company cannot without first obtaining the approval
of the holders of a majority of the then outstanding shares of Series C Preferred Stock, voting together as a class: (a) amend any provision
of the Series C Designation; (b) increase or decrease (other than by redemption or conversion) the total number of authorized shares
of Series C Convertible Preferred Stock; (c) amend the Certificate of Formation of the Company (including by designating additional series
of Preferred Stock) in a manner which adversely affects the rights, preferences and privileges of the Series C Preferred Stock; (d) effect
an exchange, or create a right of exchange, cancel, or create a right to cancel, of all or any part of the shares of another class of
shares into shares of Series C Preferred Stock; or (e) alter or change the rights, preferences or privileges of the shares of Series
C Preferred Stock so as to affect adversely the shares of such series.
Redemption
Rights . The Company may redeem the outstanding Series C Preferred Stock shares, from time to time, in whole or in part, at any time
after April 24, 2025, and continuing indefinitely thereafter, at the option of the Company, for cash, at the aggregate Liquidation Preference
of the shares redeemed.
Greenfield
Investments, Ltd.
Effective
on December 13, 2024, the Company entered into a Patent Purchase Agreement (the “ Greenfield IP Purchase Agreement ”),
with Greenfield Investments, Ltd (“ Greenfield ”). Pursuant to the Greenfield IP Purchase Agreement, we purchased certain
patents owned by Greenfield, related to nutraceutical compositions using fungal compounds derived from mushrooms (collectively, the “ Greenfield
Patents ”), in consideration for 515,000 shares of the Company’s restricted common stock (the “ IP Purchase Shares ”).
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The
Greenfield IP Purchase Agreement, and the purchase of the Greenfield Patents, closed on December 13, 2024, upon the parties entry into
the Greenfield IP Purchase Agreement, and the IP Purchase Shares were issued on December 16, 2024.
The
Greenfield IP Purchase Agreement included standard representations and warranties and confidentiality and indemnification obligations
of the parties, for a transaction of that type and size.
The
Greenfield IP Purchase Agreement also included a grant back license, whereby the Company provided Greenfield, an irrevocable, co-exclusive,
non-transferable and non-assignable (except in the event of a change of control), non-sublicensable, worldwide, license to use the Greenfield
Patents for the lives thereof (the “ Grant Back-License ”). The Grant Back-License is subject to Greenfield paying the
Company a royalty of ten percent (10%) of gross worldwide sales of products sold by Greenfield which utilize the Greenfield Patents,
beginning on December 13, 2025, and continuing until the end of the life of the last Patent (the “ Royalty Payments ”).
The Royalty Payments are to be paid to the Company on an annual basis, within 30 days after the end of the calendar year.
Finally,
the Greenfield IP Purchase Agreement granted Greenfield a right of first refusal, which provides that, if at any time prior to December
13, 2027, if we receive an offer to purchase the Greenfield Patents and determine to accept such offer, or we determine to sell the Patents
to a third party, we are required to provide Greenfield the right of first refusal to either match such offer, or negotiate different
purchase terms for the Patents.
The
Company intends to utilize the Greenfield Patents by seeking out commercial opportunities that highlight what the Company believes are
the patents innovative uses in nutraceuticals, emphasizing the potential for customized health supplements tailored to specific needs.
Insurance
We
have an insurance policy in effect that includes customary coverage and protection for professional liability, general liability, employee
benefits and protection against claims including technology products, services and against cyber security. Our insurance policy also
covers exposure to product liability claims, including both technology product claims related to customer data breaches, copyright infringement
and/or misrepresentation and fraud and any claims made in connection with any physical products and services sold through the Company’s
website.
Intellectual
Property
We
believe that our ability to obtain and maintain intellectual property protection for our technology platform, preserve the confidentiality
of our trade secrets, and operate without violating the intellectual property rights of others will be important to our success. We rely
on a combination of trademark, copyright, trade secret, including federal, state and common law rights in the United States and other
countries, nondisclosure agreements, and other measures to protect our intellectual property, and may seek patent protection of our intellectual
property in the future. Despite any measures taken to protect our intellectual property, unauthorized parties may attempt to copy aspects
of our products or to obtain and use information that we regard as proprietary. Our business is affected by our ability to protect against
misappropriation and infringement of our intellectual property and other proprietary rights.
Our
intellectual property includes the content of our websites, our registered domain names, our unregistered trademarks, and certain trade
secrets.
We
have been granted with the United States Patent and Trademark Office for a federal trademark for the following word mark on October 13,
2024 with Reg. No. 7,184,368:
Additionally,
the Company has been granted various federal trademarks and has applied for certain federal trademarks which applications are pending
as of the date of this Report.
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Employees
The
Company is currently operated and managed by (a) the Founder, Chairman and Chief Executive Officer, Jacob D. Cohen, (b) President and
Director, Antonios “ Tony ” Isaac, (c) Amanda Hammer, the Chief Operating Officer of the Company, and (d) Eugene Johnston,
the Chief Financial Officer of the Company. The Company utilizes the assistance of various independent contractors for administrative
and technology development related services. We anticipate establishing a compensation program designed to align the compensation of
our employees with performance and to provide the proper incentives to attract, retain and motivate employees to achieve superior results
in the future. The structure of our compensation program will balance incentives earnings for both short-term and long-term performance
such as incentive bonuses and flexible schedules. The Company also intends to develop a culture of inclusion and diversity and places
a high value on diversity and inclusion. Our future success will depend partially on our ability to attract, retain and motivate qualified
personnel. We are not a party to any collective bargaining agreements and have not experienced any strikes or work stoppages. We consider
our relations with our employees to be satisfactory. Mr. Cohen and Mrs. Hammer, are currently party to employment agreements with the
Company and Mr. Isaac and Mr. Johnston are party to consulting agreements with the Company, each as discussed below under “ Item 11. Executive Compensation —Employment and Consulting Agreements.”
Market
Overview
The
Market for ED Products
According
to a January 2022 report published by Verified Market Research, the Global Erectile Dysfunction Drugs Market size was valued at $3.63
billion in 2020, mainly due to the increase in patient awareness and the early adoption of sedentary lifestyle. Verified Market Research
also projects that the total Global Dysfunction Drugs Market size will contract to $2.95 billion in 2028. The expected reason for this
contraction is poor patient compliance with erectile dysfunction drugs and the future availability of cost-effective imitation medicines,
as well as side effects of ED drugs. 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. Separately, Grand View Research, in a July 2022 report, projects that
the U.S. market (where we are initially marketing our ED product) for erectile dysfunction drugs estimated at approximately $1.1 billion
as of 2021, will increase at a 7.4% compound annual growth rate though 2030.
It
is also estimated that nearly 3-in-5 men in the US have suffered from erectile dysfunction, according to a survey reported in February
2022, by LetsGetChecked, a leading at-home health screening and insights company (based on research carried out by Opinium Research among
2,006 men in the USA, 1,178 of whom had previously experienced erectile dysfunction, from February 7-10, 2020). According to that study,
age isn’t that big a factor either, with 56% of men 18 to 34 years old being affected, compared to 63% of those over the age of
55. The study also determined that most men blame psychological factors for ED – with 41% blaming stress, 34% blaming having “ too
much on their mind, ” and 31% believing it is performance anxiety.
The
Market for Mango GROW
According
to the website of the American Hair Loss Association, (a) two-thirds of American men will experience some degree of hair loss by the
age of 35, (b) by age 50, around 85 percent of men have significantly thinning hair; and (c) for around 25% of men, the start of male
pattern baldness can begin before the age of 21. Additionally, and contrary to societal belief, we believe that most men who suffer from
male pattern baldness are unhappy with their situation and would take steps to change that. In our experience, hair loss affects every
aspect of the hair loss sufferer’s life including interpersonal relationships as well as the professional lives of those suffering.
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According
to a May 2022 market study entitled, “ Hair Loss Prevention Products Market Forecast to 2028 – COVID-19 Impact and Global
Analysis – by Product Type (Shampoos and Conditioners, Oils, Serums, and Others), Category (Natural & Organic, and Conventional),
End User (Men, Women, and Unisex), and Distribution Channel (Supermarkets and Hypermarkets, Convenience Stores, Online Retail, and Others) ”,
by The Insight Partners, 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 projected compound annual growth rate of 4.2% from 2021 to 2028.
Mordor
Intelligence LLP believes that the major factors driving the hair loss prevention market are changing lifestyle patterns, adoption of
a hectic schedule that increases stress levels, which in turn results in frequent hair loss at an earlier stage among the young population,
growing disposable income, and increased emphasis on appearances.
The
Market for MOJO
We believe that hypogonadism (a condition where the gonads (testes in males and ovaries in females) do not produce
enough sex hormones) is a growing concern in an aging male population and is associated
with symptoms including decreased libido, erectile dysfunction, loss of lean muscle mass, loss of vitality, and depression. The most
sensitive symptoms supporting a diagnosis of hypogonadism include erectile dysfunction and decreased libido. Historically treated
using exogenous testosterone, concerns about possible adverse effects of testosterone have led physicians to seek alternative treatment
approaches. Enclomiphene citrate is the trans isomer of clomiphene citrate, a non-steroidal estrogen receptor antagonist
that is FDA-approved for the treatment of ovarian dysfunction in women. Clomiphene citrate has also been used off-label for many years
to treat secondary male hypogonadism, particularly in the setting of male infertility.
Enclomiphene
citrate, which is the key active pharmaceutical ingredient found in our Mango MOJO compounded product, has been researched and studied
in a Phase II clinical trial conducted by Ronald D. Wiehle and others, entitled “ Enclomiphene citrate stimulates testosterone
production while preventing oligospermia: a randomized phase II clinical trial comparing topical testosterone ” (Fertil Steril.
2014 Sep;102(3):720-7. doi: 10.1016/j.fertnstert.2014.06.004. Epub 2014 Jul 17. PMID: 25044085), which found enclomiphene citrate as
being effective in increasing serum testosterone levels in hypogonadal men, as well as maintaining sperm counts.
According
to an April 2022 market study conducted by Allied Market Research, 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% from 2021 to 2030.
The
Market for SLIM
The
Semaglutide market size has grown rapidly in recent years and from $20.54 billion in 2023 to $23.07 billion in 2024 at a compound
annual growth rate (CAGR) of 12.3% according to the “ Semaglutides Market Report 2024 ” by Research and Markets.
The growth during the historic period can be attributed to lifestyle changes leading to higher diabetes prevalence, increased investment
in research and development, rising healthcare expenditure, the expansion of pharmaceutical companies into developing regions, and growing
acceptance of injectable therapies.
Semaglutide
is the key active pharmaceutical ingredient found in our Mango SLIM compounded product. According to Research and Markets, the market for semaglutides
is expected to grow to $36.87 billion in 2028, due in part to the increasing global prevalence of diabetes, rising awareness about diabetes
management and treatment, growing demand for effective therapies with fewer side effects, supportive government initiatives and policies
for diabetes treatment, and an aging population contributing to higher diabetes incidence.
Competition
and Competitive Advantages
We
mainly compete with other companies offering men’s wellness products, including Hims & Hers Health, Inc. and Roman, and with
our Mango ED products, we compete against much larger pharmaceutical companies who offer ED branded drugs like Viagra (Pfizer) and Cialis
(marketed by Lilly ICOS LLC, a joint venture between Eli Lilly and Company and ICOS Corporation) and their generic forms. With our Mango
GROW product, we compete against the much larger pharmaceutical company Merck & Co., which offers the branded hair loss product Propecia,
and Johnson & Johnson, the owner of Rogaine® – a branded form of Minoxidil. These companies have much greater resources
than we do and well-known brand names.
Our
future men’s wellness products will also likely need to compete against other traditional healthcare providers, pharmacies, and
large retailers that sell non-prescription products.
Furthermore, we compete with other companies, which have greater resources
and a greater advertising budget, and which are also selling a version or some variation of our Compounded Products and Pharmaceutical
Products, overall. We compete against these competitors based on our branding, advertising, unique compounding, and product delivery system
(i.e., our Compounded Products have been designed to be taken sublingually, rather than in pill form or injectable format). We believe that these alternative
delivery methods are one of the Company’s major competitive advantages and what makes our Pharmaceutical Products more attractive
than those sold by some of the larger pharmaceutical manufacturing companies.
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Regulatory
Environment
We
currently produce and sell our Compounded Products, and plan to produce and sell future pharmaceutical products, under an exemption provided
by Section 503A of the FFDCA Act. Section 503A describes the conditions under which compounded human drug products are exempt from the
FFDCA Act sections on FDA approval, prior to marketing, current good manufacturing practice (“ cGMP ”) requirements
and labeling with adequate directions for use. One of these conditions is that the drugs must be compounded based on the receipt of valid
patient-specific prescriptions; another condition limits “ copying ” of FDA-approved products, which restricts compounding
drugs that have the same active ingredients and route of administration as ingredients that are used in other FDA approved drugs which
are commercially available. The FDA also prohibits any marketing or promotional statements that are “ false or misleading in
any particular, ” including making any unsupported superiority claims against other products or the failure to disclose a material
fact.
Notwithstanding
the above, under relevant FDA guidance, the FDA generally does not consider a compounded drug to be “ essentially a copy ”
of a commercially available drug if the compounded drug has a different route of administration as compared with the approved alternative,
and our Compounded Products are for a different route of administration (e.g., sublingual). In addition, the FDA does not consider a
compounded drug to be “ essentially a copy ” of a commercially available drug if the approved product cannot be used
for the prescribed route of administration, which is available in the compounded version (which we believe it cannot, as discussed below).
Finally, we do not expect that we will be deemed to have engaged in such “ copying ”, because our Compounded Products
are based on a prescriber’s determination for each patient that the change associated with the Compounded Products produces for
the patient a significant difference as compared with the commercially available drug product. Under relevant FDA guidance, the FDA does
not consider a compounded drug “ essentially a copy ” if a prescriber determines that there is a change, made for an
identified individual patient, which produces for that patient a significant difference from the commercially available product.
Under
Section 503A of the FFDCA Act, it is the prescribing practitioner who determines if a compounded drug is necessary for the identified
patient and whether the change associated with the compounded product produces for the patient a significant difference as compared with
the commercially available drug product. FDA’s guidance states that FDA generally does not intend to question prescriber determinations
that are appropriately documented. Our Compounded Products have been formulated as a Rapid Dissolve Tablet using a sublingual (applied
under the tongue) delivery system to bypass the stomach and liver. We believe this offers a significant difference based on the fact
that the approved versions are not available in the same route of administration (i.e., sublingual). A sublingual formulation may be
able to meet the clinical needs of a particular patient who desires a more rapid onset of action compared to an FDA-approved oral formulation.
In addition, because the prevalence of ED generally increases with age, older patients who may have difficulty swallowing an FDA-approved
oral formulation may benefit from a sublingual formulation that dissolves under the tongue.
Compounded
drugs, like our Compounded Products, are not FDA-approved. This means that the FDA does not verify the safety or effectiveness of such
drugs. Instead, consumers rely on the determination of a prescribing physician that the compounded drug is necessary for the individual
patient. Compounded drugs also lack an FDA finding of manufacturing quality before such drugs are marketed.
The
FDA has the authority to impose significant restrictions on products through regulations on advertising, promotional and distribution
activities. In particular, the FDA will object to any promotional activity (including through testimonials and surrogates) that is “ false
or misleading in any particular, ” including the failure to disclose material facts. For example, the FDA will expect adequate
substantiation for an efficacy claim, which would require substantial evidence derived from adequate and well-controlled clinical trials.
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.
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We
are also aware of data in the scientific literature supporting how the proposed combination of the compounds which make up our Mango
ED products (i.e., Tadalafil or Sildenafil, Oxytocin, and L-arginine) might be expected to perform in ED patients. Previous clinical
studies (none of which we have paid for or undertaken ourselves) have suggested that either Sildenafil Tadalafil and L-arginine in combination
for treatment of ED may be more effective than either compound alone (see L. Gallo et al., The Daily Therapy With L-Arginine 2,500
mg and Tadalafil 5 mg in Combination and in Monotherapy for the Treatment of Erectile Dysfunction: A Prospective, Randomized Multicentre
Study , 8 Sex Med 178, 184 (June 2020) – finding that in general, combination
therapy with Tadalafil and L-Arginine was superior to monotherapies for the treatment of ED; and M. Abu El-Hamd & E. Mohammed Hegazy,
Comparison of the clinical efficacy of daily use of L-arginine, tadalafil and combined L-arginine with tadalafil in the treatment
of elderly patients with erectile dysfunction , 52 Andrologia e13640, 3 (Aug. 2020)
(“ Hamd and Hegazy ”) – finding that the combined daily use of L-arginine with Tadalafil therapy for elderly male
patients with ED could significantly increase Sexual Health Inventory for Men (SHIM) scores and levels of total testosterone in comparison
to L-arginine, or Tadalafil alone)—This is because L-arginine may increase nitric oxide, that in turn may increase cyclic guanosine
monophosphate, which has relaxation and vasodilation (dilatation of blood vessels) effects on smooth muscle to assist in the treatment
of ED (see Hamd and Hegazy paper). Furthermore, Oxytocin is a neurotransmitter linked to increased levels of social interaction, well-being,
and anti-stress effects and clinical studies suggest administration of Oxytocin may stimulate certain aspects of social interaction,
and may cause anti-anxiety and anti-stress effects (see Hamd and Hegazy paper).
Furthermore,
we are aware of data in the scientific literature supporting the efficacy of Minoxidil as an oral treatment (as discussed below), as
opposed to topical treatments that have been more traditionally used and marketed for hair growth to date. Topical Minoxidil and oral
Finasteride are current the standard first-line treatments for androgenetic alopecia (AGA)(male pattern baldness). Minoxidil in an oral
formulation has been previously used for the treatment of severe and uncontrolled hypertension at a dose of 10–40 mg. Unintentionally,
the early trials of oral minoxidil as an antihypertensive drug documented side effects such as hypertrichosis (excessive hair growth
anywhere on the body) and hirsutism (excess hair most often noticeable around the mouth and chin) with chronic use. A study conducted
by Ratchathorn Panchaprateep & Suparuj Lueangarun, and published in the September 24, 2020 edition of Dermatology and Therapy, found
that oral minoxidil at a dose of 5 mg taken once daily, significantly increased hair growth in men with AGA after 12 and 24 weeks of
treatment (Panchaprateep, R., Lueangarun, S. Efficacy and Safety of Oral Minoxidil 5 mg Once Daily in the Treatment of Male Patients
with Androgenetic Alopecia: An Open-Label and Global Photographic Assessment. Dermatol Ther (Heidelb) 10, 1345–1357 (2020)).
Separately,
Finasteride taken orally in the amount of 1 mg per day has shown to promote scalp hair growth and prevent further hair loss in a significant
proportion of men with male pattern hair loss (McClellan, K.J., Markham, A. Finasteride. Drugs 57, 111–126 (1999).
Neither
we, nor our representatives have had any conversations with the FDA staff regarding whether our Compounded Products can be sold pursuant
to Section 503A of the FFDCA Act and future conversations with the FDA may result in the FDA staff raising issues with such sales pursuant
to Section 503A of the FFDCA, requiring certain pre-requisites or changes to our current business plan, which may be costly or time consuming,
and/or may result in us being prohibited from selling our Compounded Products pursuant to Section 503A of the FFDCA Act.
Government
Regulation
We,
as are many other companies, are also subject to environmental laws, rules and regulations which could affect our operations, including
those disclosed below. As a consumer-focused health and wellness company delivering comprehensive telehealth technologies and services
and health and wellness prescription-based products, in addition to the typical legal and regulatory considerations faced by a technology-based
company, we are required to comply with complex healthcare laws and regulations, and consumer protection laws and regulations, all at
both the state and federal level. Our business and operations are subject to extensive regulation, including with respect to the practice
of medicine, the use of telehealth, relationships with healthcare providers, privacy and security of personal health information, product
safety and pharmacy operations.
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Government
regulation of healthcare generally
Generally
speaking, the healthcare industry is one of the most highly regulated industries in the United States. Healthcare-related businesses
are subject to a broad array of governmental regulation at the federal, state, and local levels. While portions of our business are subject
to significant regulations, some of the more well-known healthcare regulations do not apply to the Company because of the way our current
operations are structured. We currently accept payments only from our customers—not any third-party payors, such as government
healthcare programs or health insurers. Because of this approach, we are not subject to many of the laws and regulations that impact
other participants in healthcare industry. If we begin accepting reimbursement payments from insurance providers or other third-party
payors such as a government program, we will become subject to some of these additional healthcare laws and regulations.
Irrespective
of our business model, the healthcare industry is subject to changing political, economic and regulatory influences that may affect health
and wellness companies like the Company. During the past several years, the healthcare industry has been subject to an increase in governmental
regulation and subject to potential disruption due to legislative initiatives and government regulation, as well as judicial interpretations
thereof. While these regulations may not directly impact us or our offerings in any given case, they will affect the healthcare industry
as a whole and may impact customer use of the Company’s solutions. If the government asserts broader regulatory control over companies
like us or if we accept payment from and/or participate in third-party payor programs in the future, the complexity of our operations
and our compliance obligations will materially increase.
Government
regulation of the practice of medicine and telehealth
The
practice of medicine is subject to various federal, state, and local certification and licensing laws, regulations, approvals and standards,
relating to, among other things, the qualifications of the provider, the practice of medicine (including specific requirements when providing
health care utilizing telehealth technologies and the provision of remote care), the continuity and adequacy of medical care, the maintenance
of medical records, the supervision of personnel, and the prerequisites for the prescription of medication and ordering of tests. Because
the practice of telehealth is relatively new and rapidly developing, regulation of telehealth is evolving and the application, interpretation
and enforcement of these laws, regulations and standards can be uncertain or uneven. Similarly, the ability of our related party pharmacy
to fulfill prescriptions and distribute pharmaceutical products, including compounded pharmaceutical products, is dependent upon the
laws that govern licensed pharmacies and the fulfillment and distribution of prescription medication and other pharmaceutical products,
which include in some cases requirements relating to telehealth. As a result, we must continually monitor legislative, regulatory, and
judicial developments regarding the practice of medicine, telehealth and pharmaceutical laws in order to support our related party pharmacy
(Epiq Scripts) and our third-party Telemedicine Providers.
Physicians
who provide professional clinical services via telehealth must, in most instances, hold a valid license to provide the applicable professional
services in the state in which the patient is located. As such, the physicians provided to us through our relationship with our Telemedicine
Providers are required to be licensed under applicable state law.
Additionally,
there may be limitations placed on the modality through which telehealth services are delivered. For example, some states specifically
require synchronous (or “ live ”) communications and restrict or exclude the use of asynchronous telehealth modalities,
which is also known as “ store-and-forward ” telehealth. However, other states do not distinguish between synchronous
and asynchronous telehealth services. In response to the COVID-19 pandemic, some state and federal regulatory authorities lowered certain
barriers to the practice of telehealth in order to make remote healthcare services more accessible. Due to our business model, these
changes did not dramatically change our operations, but these changes did introduce many people to the practice of telehealth. It is
unclear whether these changes will have a long-term impact on the adoption of telehealth services by the general public or legislative
and regulatory authorities.
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Some
of the rules and regulations we are subject to include:
Federal
Anti-Kickback Statute
The
Federal Anti-Kickback Statute (42 U.S.C. § 1320a-7b) is broadly worded and prohibits the knowing and willful offer, payment, solicitation
or receipt of any form of remuneration in return for, or to induce, (i) the referral of a person covered by Medicare, Medicaid or other
governmental programs, (ii) the furnishing or arranging for the furnishing of items or services reimbursable under Medicare, Medicaid
or other governmental programs or (iii) the purchasing, leasing or ordering or arranging or recommending purchasing, leasing or ordering
of any item or service reimbursable under Medicare, Medicaid or other governmental programs. In addition, a person or entity does not
need to have actual knowledge of this statute or specific intent to violate it to have committed a violation. Moreover, the government
may assert that a claim including items or services resulting from a violation of the Anti-Kickback Statute constitutes a false or fraudulent
claim for purposes of the False Claims Act, we do not expect to apply to our operations as we do not plan to seek payment for our services
from the federal government. Violations of the Anti-Kickback Statute can result in exclusion from Medicare, Medicaid or other governmental
programs as well as civil and criminal penalties and fines. Imposition of any of these remedies could have a material adverse effect
on our business, financial condition and results of operations.
We
do not anticipate our current operations being subject to the Anti-Kickback Statute as we do not seek reimbursement under a federal health
care program.
U.S.
FDA Regulation
The
FDA regulates product promotion and noncompliance and this could result in the FDA requesting that we modify our product promotion or
subject us to regulatory and/or legal enforcement actions, including the issuance of a warning letter, injunction, seizure, civil fine,
and criminal penalties. Other federal, state or foreign enforcement authorities also monitor product promotion and have the authority
to levy significant fines or penalties under other statutory authorities, such as laws prohibiting false claims for reimbursement, if
violations of applicable law or regulations occur. We also believe that the FDA will likely consider our compounded combination products
to be different from previously FDA-approved products, and that the FDA will not likely allow us to rely on any FDA-approved labeling
or prescribing information.
To
qualify for the exemptions under section 503A of the FFDCA Act, among other requirements, a drug must be compounded by a licensed pharmacist
or a licensed physician that does not compound regularly or in inordinate amounts any drug products that are essentially copies of a
commercially available drug product. As discussed under “ Item 1. Business—Material Agreements—Master Services Agreement
with Epiq Scripts ”, we have entered into an agreement with Epiq Scripts, a related party, 52% owned and controlled by Jacob
D. Cohen, our Chairman and Chief Executive Officer, to provide us compounding and other pharmacy services.
Our
operations are subject to extensive government regulation, from the entry into agreements with physicians or groups of physicians to
provide telehealth services to our potential customers, to the marketing and promotion of our products, the creation of our products,
and the sale of our products through licensed pharmacists.
Risk
of Litigation
Additionally,
federal and state statutes provide for private causes of action to plaintiffs alleging misleading marketing claims, or otherwise making
allegations which are found to be in violation of such laws. As such, misleading promotional statements and practices can lead to litigation
under state consumer protection and unfair trade practices laws. To date, there has been a substantial amount of litigation under these
laws challenging the marketing and sale of compound drugs and we may face legal actions, and be subject to significant penalties, judgments
and damages, if we are found to have violated these laws.
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Health
Information Privacy and Security Laws
Numerous
U.S. state and federal laws and regulations govern the collection, dissemination, use, privacy, confidentiality, security, availability,
integrity, and other processing of health information. We believe that, because of our operating processes, we are not a covered entity
or a business associate under the Health Insurance Portability and Accountability Act and the implementing regulations (“ HIPAA ”),
which establishes a set of national privacy and security standards for the protection of protected health information by health plans,
healthcare clearinghouses, and certain healthcare providers, referred to as covered entities, and the business associates with whom such
covered entities contract for services. Because we need to use and disclose customers’ health and personal information in order
to provide our services, we develop and maintain policies and procedures to protect that information in the future.
In
addition to HIPAA, numerous other federal, state, and foreign laws and regulations protect the confidentiality, privacy, availability,
integrity and security of health information and other types of personal information. These laws and regulations are often uncertain,
contradictory, and subject to changing or differing interpretations. Additionally, these laws may be similar to or even more protective
than, and may not be preempted by, HIPAA and other federal privacy laws. The privacy and data protection laws in many states in which
we operate are more restrictive than HIPAA and/or may apply more broadly than HIPAA. In certain cases, it may be necessary to modify
our operations and procedures to comply with these more stringent state laws. Not only may some of these state laws impose fines and
penalties upon violators, but also some, unlike HIPAA, may afford private rights of action to individuals who believe their personal
information has been misused. We expect new laws, rules and regulations regarding privacy, data protection, and information security
to be proposed and enacted in the future; as state laws are changing rapidly.
For
example, as of the date of this Report, twenty states—California, Colorado, Connecticut, Delaware, Florida, Indiana, Iowa, Kentucky,
Maryland, Montana, Minnesota, Montana, New Hampshire, Nebraska, New Jersey, Oregon, Rhode Island, Tennessee, Texas, Utah, and Virginia—have
enacted consumer data privacy laws. The data privacy laws have a number of things in common with each other, including allowing residents
of those states the right to access and delete their personal information and to opt-out of the sale of their personal information, among
others. Other provisions require commercial websites or online services to post a privacy policy that describes the types of personal
information collected, what information is shared with third parties, and how consumers can request changes to certain information. Our
compliance with these and future rules may increase our operating and expenses and our failure to comply with these rules could subject
us to fines, penalties and litigation.
In
addition to the above, proposed or new legislation and regulations could also significantly affect our business. There currently are
a number of proposals pending before federal, state, and foreign legislative and regulatory bodies.
Product
Liability
As
a distributor of men’s health and wellness products, the Company faces an inherent risk of exposure to product liability claims,
regulatory action and litigation if its future products are alleged to have caused significant loss or injury. In addition, the sale
of our products involves the risk of injury to consumers due to tampering by unauthorized third parties or product contamination. Previously
unknown adverse reactions resulting from human consumption of our products alone or in combination with other medications or substances
could occur. We may be subject to various product liability claims, including, among others, that our future products caused injury or
illness, include inadequate instructions for use or include inadequate warnings concerning possible side effects or interactions with
other substances. A product liability claim or regulatory action against the Company could result in increased costs, could adversely
affect our reputation with our clients and consumers generally, and could have a material adverse effect on our results of operations
and financial condition of the Company.
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For
example, a 2014 study published in The Journal of the American Medical Association determined that Sildenafil (the active ingredient
in Viagra) may be associated with a higher risk of developing melanoma. The study evaluated data from more than 25,000 men who used Sildenafil
and found that Sildenafil use was significantly associated with an increased risk of subsequent melanoma, after considering other risk
factors. It is possible that the ingredients we use in our Mango ED and Mango GROW products or any other products we sell in the future
could be found in the future to result in increases in the likelihood of developing cancer or other diseases, which could subject us
to litigation, penalties or recalls.
Implications
of Being an Emerging Growth Company
As
a company with less than $1.235 billion in revenue during our last fiscal year, we qualify as an “ emerging growth company ”
under the Jumpstart Our Business Startups Act of 2012, or the JOBS Act. As an emerging growth company, we have elected to take advantage
of reduced reporting requirements and are relieved of certain other significant requirements that are otherwise generally applicable
to public companies. As an emerging growth company:
●
we may present only two years of audited financial statements and only two years of related Management’s Discussion and Analysis
of Financial Condition and Results of Operations;
●
we are exempt from the requirement to obtain an attestation and report from our auditors on whether we maintained effective internal
control over financial reporting under the Sarbanes-Oxley Act;
●
we are permitted to provide less extensive disclosure about our executive compensation arrangements; and
●
we are not required to give our shareholders non-binding advisory votes on executive compensation or golden parachute arrangements.
We
may take advantage of these provisions until December 31, 2028 (the last day of the fiscal year following the fifth anniversary of our
initial public offering) if we continue to be an emerging growth company. We would cease to be an emerging growth company if we have
more than $1.235 billion in annual revenue, have more than $700 million in market value of our shares held by non-affiliates or issue
more than $1.0 billion of non-convertible debt over a three-year period. We may choose to take advantage of some but not all of these
reduced burdens. We have elected to provide two years of audited financial statements. Additionally, we have elected to take advantage
of the extended transition period provided in Section 7(a)(2)(B) of the Securities Act, for complying with new or revised accounting
standards that have different effective dates for public and private companies until the earlier of the date we (i) are no longer an
emerging growth company or (ii) affirmatively and irrevocably opt out of the extended transition period provided in Section 7(a)(2)(B)
of the Securities Act.
Item
1A. Risk Factors.
Our
business is subject to numerous risks and uncertainties that you should be aware of in evaluating our business. If any such risks and
uncertainties actually occur, our business, prospects, financial condition and results of operations could be materially and adversely
affected, and the value of our securities may decline in value or become worthless. The risks described below are not the only risks
that we face. Additional risks and uncertainties not currently known to us, or that we currently deem to be immaterial may also materially
adversely affect our business, prospects, financial condition and results of operations. The risk factors described below should be read
together with the other information set forth in this Report, including our consolidated financial statements and the related notes, as well as in
other documents that we file with the SEC.
Summary
Risk Factors
Our
business is subject to numerous risks and uncertainties, including those described below and elsewhere in this Report. These risks include,
but are not limited to, the following:
●
Our
need for additional funding, the availability and terms of such funding, and dilution caused thereby;
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●
We
have a limited operating history, have produced only a limited amount of products and have generated only limited revenues to date;
●
Our
ability to execute our growth strategy and scale our operations and risks associated with such growth, and our ability to attract
members and customers;
●
The
effect of pandemics and governmental responses thereto on our operations, those of our vendors, our customers and the economy in
general;
●
Risks
associated with our ED product which has not been, and will not be, approved by the FDA and has not had the benefit of the FDA’s
clinical trial protocol which seeks to prevent the possibility of serious patient injury and death;
●
Risks
that the FDA may determine that the compounding of our planned products does not fall within the exemption from the FFDCA Act provided
by Section 503A;
●
Our
significant reliance on related party transactions and risks associated with such related party relationships and agreements;
●
The
effect of data security breaches, malicious code and/or hackers;
●
Competition
and our ability to create a well-known brand name;
●
Changes
in consumer tastes and preferences;
●
Material
changes and/or terminations of our relationships with key parties;
●
Significant
product returns from customers, product liability, recalls and litigation associated with tainted products or products found to cause
health issues;
●
Our
ability to innovate, expand our offerings and compete against competitors which may have greater resources;
●
Our
ability to prevent credit card and payment fraud;
●
Risks
associated with inflation, and increases in interest rates 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 Israel/Hamas
conflict) and other large-scale crises;
●
The
risk of unauthorized access to confidential information;
●
Our
ability to protect our intellectual property and trade secrets, claims from third-parties that we have violated their intellectual
property or trade secrets and potential lawsuits in connection therewith;
●
Our
and our providers’ ability to comply with government regulations, changing regulations and laws, penalties associated with
any non-compliance (inadvertent or otherwise), the effect of new laws or regulations, and our ability to comply with such new laws
or regulations;
●
Our
reliance on our current management and the terms of their employment agreements with us;
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●
The
outcome of lawsuits, litigation, regulatory matters or claims;
●
The
fact that certain recent initial public offerings of companies with public floats comparable to the public float of the Company have
experienced extreme volatility that was seemingly unrelated to the underlying performance of the respective company; and the fact
that we may experience similar volatility, which may make it difficult for investors to assess the value of our common stock;
●
Certain
terms and provisions of our governing documents which may prevent a change of control, and which provide for indemnification of officers
and directors, limit the liability of officers or directors, and provide for the board of director’s ability to issue blank
check preferred stock; and
●
The
volatile nature of the trading price of our common stock; dilution experienced by investors in the offering; and dilution which may
be caused by future sales of securities.
Risks
Related to our Operating History and Need for Funding
We
have a limited operating history and have generated only limited revenues to date and there is no assurance that we can generate revenues
or sell any commercial amount of our products in the future. We will need to raise additional funding to support our operations in the
future.
We
have a limited operating history. We launched our website in mid-November 2022 and have not sold sufficient quantities of our PRIME and/or
Compounded Products to date to support our operations. There is no assurance that we can generate revenues sufficient to support our
operations, and even if additional revenues are generated, there is no assurance that we can generate sufficient net income to support
our operations. As reflected in the accompanying financials, the Company had a net loss of $8,707,226 for the year ended December 31, 2024 and an accumulated deficit
of $20,806,595 as of December 31, 2024. Additionally, the Company had a net loss of $9,212,417 for the year ended December 31, 2023, and
an accumulated deficit of $11,228,173 as of December 31, 2023.
We
have experienced recurring net losses since inception. We believe that we will continue to incur substantial operating expenses in
the foreseeable future as we continue to invest to market our PRIME and Compounded Products, expand product offerings and enhance
technology and infrastructure and further invest into, develop and market our recently acquired intellectual properties, including our patented
respiratory illness prevention technology and Dermytol . These efforts may prove more expensive than we anticipate, and we may not succeed in generating
commercial revenues or net income to offset these expenses. Accordingly, we may not be able to achieve profitability, and we may
incur significant losses for the foreseeable future. Our independent registered public accounting firm included an explanatory
paragraph in its report on our consolidated financial statements as of December 31, 2024, included herein. As of the date of this Report, our
current capital resources, combined with the net proceeds from recent offerings are expected to be sufficient for us to fund
operations for the next 12 months. We will need funding in in the future however to support our operations. We may also seek to
acquire additional businesses or assets in the future, which may require us to raise funding. We currently anticipate such funding,
if required, being raised through the offering of debt or equity. Such additional financing may not be available on favorable terms,
if at all. If debt financing is available and obtained, our interest expense may increase and we may be subject to the risk of
default, depending on the terms of such financing. If equity financing is available and obtained it may result in our shareholders
experiencing significant dilution. If such financing is unavailable, we may be forced to curtail our business plan, which may cause
the value of our securities to decline in value.
Since
we have a limited operating history, it is difficult for potential investors to evaluate our business and our business is in a relatively
new consumer product segment, which is difficult to forecast.
Our
limited operating history in the health and wellness industry may hinder our ability to successfully meet our objectives and makes it
difficult for potential investors to evaluate our business or prospective operations. As an early-stage company, we are subject to all
the risks inherent in the financing, expenditures, operations, regulatory compliance, complications and delays inherent in a new business.
Accordingly, our business and success face risks from uncertainties faced by developing companies in a competitive environment. The likelihood
of our success must be considered in light of the problems, expenses, difficulties, regulatory challenges, complications and delays frequently
encountered in connection with the formation of a new business, the development of a new strategy and the competitive environment in
which we operate. There can be no assurance that our efforts will be successful or that we will ultimately be able to attain profitability.
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Additionally,
our industry segment is relatively new and constantly evolving. As a result, there is a lack of available information with which to forecast
industry trends or patterns. There is no assurance that sustainable industry trends or preferences will develop that will lead to predictable
growth or earnings forecasts for individual companies or the industry segment as a whole. We are also unable to determine what impact
future governmental regulation may have on trends and preferences or patterns within our industry segment.
We
need additional capital which may not be available on commercially acceptable terms, if at all, and this raises questions about our ability
to continue as a going concern.
We
need additional capital to support our operations and continue to market and commercialize our current Pharmaceutical Products. We may
also require additional funding in the future to support our operations, expand our product line, pay expenses, or expand or complete
acquisitions. The most likely source of future funds presently available to us will be through the sale of equity capital or debt. Any
sale of equity or convertible equity or debt will result in dilution to existing shareholders. Furthermore, we may incur debt in the
future, and may not have sufficient funds to repay our future indebtedness or may default on our future debts, jeopardizing our business
viability.
We
may not be able to borrow or raise additional capital in the future to meet our needs or to otherwise provide the capital necessary to
expand our operations and business, which might result in the value of our securities decreasing in value or becoming worthless. Additional
financing may not be available to us on terms that are acceptable. Consequently, we may not be able to proceed with our intended business
plans. Obtaining additional financing contains risks, including:
●
additional
equity financing may not be available to us on satisfactory terms and any equity or convertible equity or debt we are able to issue
could lead to dilution for current shareholders;
●
loans
or other debt instruments may have terms and/or conditions, such as interest rate, restrictive covenants and control or revocation
provisions, which are not acceptable to management or our directors;
●
the
current environment in capital markets combined with our capital constraints may prevent us from being able to obtain adequate debt
financing; and
●
if
we fail to obtain required additional financing to commercialize our products and grow our business, we would need to delay or scale
back our business plan, reduce our operating costs, or delay product launches, each of which would have a material adverse effect
on our business, future prospects, and financial condition.
Additionally,
we may have difficulty obtaining additional funding, and we may have to accept terms that would adversely affect our shareholders. For
example, the terms of any future financings may impose restrictions on our right to declare dividends (provided that none are currently
planned) or on the manner in which we conduct our business. Additionally, lending institutions or private investors may impose restrictions
on a future decision by us to make capital expenditures, acquisitions or significant asset sales. If we are unable to raise additional
funds, we may be forced to curtail or even abandon our business plan.
Risks
Related to Our Business Activities
We
may not be able to successfully commercialize our Pharmaceutical Products or any other potential future men’s wellness products.
We
may not be able to effectively commercialize our Pharmaceutical Products or any other potential future men’s wellness products.
If we are unable to successfully commercialize our Pharmaceutical Products or successfully develop, produce, launch and commercialize
any other potential future men’s wellness products, our ability to generate product sales will be severely limited, which will
have a material adverse impact on our business, financial condition, and results of operations.
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We
expect to face intense competition, often from companies with greater resources and experience than we have.
The
health, wellness, and telemedicine industries are highly competitive and subject to rapid change. The industries continue to expand and
evolve as an increasing number of competitors and potential competitors enter the market. Many of these competitors and potential competitors
have substantially greater financial, technological, managerial and research and development resources and experience than we have. We
mainly compete with other companies offering men’s compounded health and wellness products, including Hims & Hers Health, Inc.,
Roman, and Henry Meds, and with our Mango ED products, we are also competing against much larger pharmaceutical companies who offer ED
branded drugs like Viagra (Pfizer) and Cialis (marketed by Lilly ICOS LLC, a joint venture between Eli Lilly and Company and ICOS Corporation)
and their generic forms. With our Mango GROW product, we compete against the much larger pharmaceutical company Merck & Co., which
offers the branded hair loss product Propecia, and Johnson & Johnson, the owner of Rogaine® – a branded form of Minoxidil.
With our Mango SLIM product, we compete against the much larger pharmaceutical company Novo Nordisk., which offers the branded glucagon-like
peptide-1 (GLP-1 ) products under the brand name Ozempic® and Wegovy®. The majority of these competitors and potential
competitors have more experience than we have in the development of health and wellness services and products. In addition, our planned
services and products will compete with service and product offerings from large and well-established companies that have greater marketing
and sales experience and capabilities than we or the parties with which we contract have. If we are unable to compete successfully, we
may be unable to grow and sustain our revenue.
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.
Many
competitors also have longer operating histories, and will have larger fulfillment infrastructures, greater technical capabilities, faster
shipping times, lower-cost shipping, lower operating costs, greater financial, marketing, institutional and other resources and larger
consumer bases than we do. These factors may also allow our competitors to derive greater revenue and profits from their existing consumer
bases, acquire consumers at lower costs or respond more quickly than we are able to, to new or emerging technologies and changes in product
trends and consumer shopping behavior. These competitors may engage in more extensive research and development efforts, enter or expand
their presence in any or all of the ecommerce or retail channels where we compete, undertake more far-reaching marketing campaigns, and
adopt more aggressive pricing policies, which may allow them to build larger consumer bases or generate revenue from their existing consumer
bases more effectively than we are able to. As a result, these competitors may be able to offer comparable or substitute products to
consumers at similar or lower costs. This could put pressure on us to lower our prices, resulting in lower revenue and margins or cause
us to lose market share even if we lower prices.
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Furthermore,
companies with greater resources or more well-known brand names may attempt to compete with us, and as a result, we may lose current
or potential customers and may be unable to generate sufficient revenues to support our operations, any one of which could have a material
adverse effect on our ability to grow and our results of operations.
We
may not successfully compete with larger competitors that have greater financial, sales, technical and other resources. Companies with
greater resources may acquire our competitors or launch new products, and they may be able to use their resources and scale to respond
to competitive pressures and changes in consumer preferences by reducing prices or increasing promotional activities, among other things.
We
face, and may continue to face, intellectual property infringement or misappropriation, and other claims that could be costly to defend,
result in significant damage awards or other costs (including indemnification awards), and limit our ability to sell certain products.
We
are currently party to, and may in the future continue to be party to, litigation based on allegations of infringement or other violations
of intellectual property rights, including patent, copyright, trade secrets, and trademarks. Adverse results in any of these lawsuits
may include awards of monetary damages, costly royalty or licensing agreements (if licenses are available at all), or orders limiting
our ability to sell our products in the U.S. or elsewhere, including by preventing us from selling some or all of our Compounded Products.
They may also cause us to change our business practices in ways that could result in a loss of revenues for us and otherwise harm our
business. Some of our agreements with our partners require us to defend against certain intellectual property infringement claims and
in some cases indemnify them for certain intellectual property infringement claims against them, which could result in increased costs
for defending such claims or significant damages if there was an adverse ruling in any such claims. Regardless of their merits, intellectual
property claims are often time consuming and expensive to litigate or settle. To the extent such claims are successful, they could harm
our business, including our product offerings, financial condition, and operating results. In the event we were prohibited from selling
certain, or all of our Compounded Products, and/or were forced to pay significant damages, we may be forced to curtail our business operations
and seek bankruptcy protection.
For
additional information about the ongoing material legal proceedings to which we are subject, see Legal Proceedings in Item 3 of this
Annual Report on Form 10-K.
We
may enter into strategic transactions in the future which may result in a material change in our operations and/or a change of control.
The
costs and expenses of our public reporting obligations are material, and materially affect our quarterly results of operations and profitability.
The Company has recently initiated a formal review process to evaluate strategic alternatives for the Company. The Board of Directors
and management team are committed to acting in the best interests of the Company, its stockholders and its stakeholders. There is no
deadline or definitive timetable set for completion of the strategic alternatives review process and there can be no assurance that this
process will result in the Company pursuing a transaction or any other strategic outcome. Transactions which may be undertaken by the
Company, may include, but are not limited to, business combinations, liquidations of assets and/or a sale of the Company or its assets.
The Company does not intend to make any further public comment regarding the review of strategic alternatives until it has been completed
or the Company determines that a disclosure is required by law or otherwise deemed appropriate.
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As
a result of the above, in the future, we or our majority stockholders, may enter into transactions with parties seeking to merge and/or
acquire us and/or our operations. While we have not entered into any agreements or understandings with any such parties to date, in the
event that we do enter into such a transaction or transactions in the future, our majority stockholder(s) will likely change and new
shares of common stock or preferred stock could be issued resulting in substantial dilution to our then current stockholders. As a result,
our new majority stockholders may change the composition of our Board of Directors and may replace our current management. Any future
transaction may also result in a change in our business focus. We have not entered into any agreements relating to any strategic transaction
involving the Company as of the date of this filing and may not enter into such agreements in the future. Any future strategic transaction
involving the Company or its operations may have a material effect on our operations, cash flows, results of operations, prospects, plan
of operations, the listing of our common stock on Nasdaq, our officers, directors and majority stockholder(s), and the value of our securities.
If
we fail to successfully provide a good customer experience, including by developing new product offerings, our ability to attract members
and customers may be materially adversely affected.
Our
ability to obtain customers and retain future customers, attract customers and increase customer engagement with us will depend in part
on our ability to successfully implement and improve our customer experience, including by continuing to create and introduce new product
offerings, improving upon and enhancing our existing product offerings and strengthening our customers interactions with our brand and
products. If new or enhanced product offerings are unsuccessful, we may be unable to attract or retain customers and our operating results
could be materially adversely affected. Furthermore, new or shifting customer demands, tastes or interests, superior competitive offerings
or a deterioration in our product offering quality or our ability to bring new or enhanced product offerings to market quickly and efficiently
could negatively affect the attractiveness of our products and the economics of our business and require us to make substantial changes
to and additional investments in our product offerings or business model.
Counterfeit
versions of our products could harm our customers and have a negative impact on our revenues, earnings, reputation and business.
Our
industry is subject to illegal counterfeiting and the presence of counterfeit products in certain of our markets and over the Internet.
Third parties may illegally distribute and sell counterfeit versions of our products, which do not meet our manufacturing and testing
standards, and which contain varying ingredients. To customers counterfeit products may be visually indistinguishable from the authentic
version. Counterfeit products pose a risk to customer health and safety because of the conditions under which they are manufactured as
well as the lack of regulation of their ingredients. The sale of counterfeit products could adversely impact our business and reputation
by impacting customer confidence in our authentic products, potentially resulting in lost sales, product recalls, and an increased threat
of litigation.
We
may expend our limited resources to pursue particular products or services and may fail to capitalize on products or services that may
be more profitable or for which there is a greater likelihood of success.
Because
we have limited financial and managerial resources, we must focus our efforts on particular service programs and products. As a result,
we may forego or delay pursuit of opportunities with other services or products that later prove to have greater commercial potential.
Our resource allocation decisions may cause us to fail to capitalize on viable commercial products or profitable market opportunities.
Any such failure could result in missed opportunities and/or our focus on products or services with low market potential, which would
harm our business and financial condition. Our current use of proceeds is specifically focused on among other things, the marketing and
selling of our current Pharmaceutical Products and includes capital allocated for future products or services anticipated to be sold
in the future under the ‘MangoRx’ label and brand.
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We
have entered into a Master Services Agreement and Statement of Work with Epiq Scripts, LLC, a related party, which entity is currently
licensed to provide pharmacy services in only 49 states and the District of Columbia.
As
described in greater detail under “ Item 1. Business—Material Agreements—Master Services Agreement with Epiq Scripts ”.
we have entered into a Master Services Agreement and SOW for Epiq Scripts, a related party, 52% owned and controlled by Jacob D. Cohen,
our Chairman and Chief Executive Officer, to provide us pharmacy and compounding services. Epiq Scripts has filed with the URAC to obtain
its pharmacy accreditation and has State Board of Pharmacy (or its equivalent) licenses in the District of Columbia and 49 states: Alaska,
Arizona, Arkansas, California, Colorado, Connecticut, Delaware, Florida, Georgia, Hawaii, Idaho, Illinois, Indiana, Iowa, Kansas, Kentucky,
Louisiana, Maine, Maryland, Massachusetts, Michigan, Minnesota, Mississippi, Missouri, Montana, Nebraska, Nevada, New Hampshire, New
Jersey, New Mexico, New York, North Carolina, North Dakota, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina South
Dakota, Tennessee, Texas, Utah, Vermont, Virginia, Washington, West Virginia, Wisconsin, and Wyoming. It is also in the process of applying
for additional state licenses and plans to eventually obtain licenses in all 50 states by the end of the first quarter of 2025. As a
result of the above, Epiq Scripts can currently only provide the Services to us in the 49 states described above and the District of
Columbia, and we are unable to sell products to any customers in any states other than those 49 states and the District of Columbia,
until Epiq Scripts is able to obtain licenses in other states and is limited to selling products to customers only in the states in which
Epiq Scripts holds licenses.
The
Master Services Agreement does not address product liability claims which may result in us bringing legal claims or actions against Epiq
Scripts to attempt to seek indemnification or contribution for product liability claims.
Each
party to the Master Services Agreement agreed to indemnify, defend, and hold harmless the other and the other party’s officers,
directors, shareholders, employees, and agents from and against any and all nonparty claims, or actions for damages, liabilities (including
strict liability), penalties, costs and expenses (including reasonable legal fees, expenses and costs) to the proportionate extent caused
by (1) the negligence or willful misconduct of the indemnitor or any of its employees or agents in connection with the performance of
the agreement, or (2) any breach of any representation, warranty or covenant under the agreement by the indemnitor or any of its employees
or agents. Additionally, the parties agreed that neither party will be liable to the other for special, incidental, or exemplary damages,
subject to certain limited exceptions. The Master Services Agreement does not address product liability claims or assign any rights of
indemnification or contribution in connection therewith. As a result, in the event of product liability claims, we may be forced to bring
legal claims or actions against Epiq Scripts to attempt to seek indemnification or contribution for product liability claims, to the
extent that we are sued in connection with such claims and Epiq Scripts isn’t sued or that we are found primarily liable for such
claims. Such claims may be costly, time consuming, and may not ultimately result in a favorable outcome to us, all of which may have
an adverse effect on the value of our securities.
We
currently owe certain rights to Epic Scrips under the Management Services Agreement which may limit our future operations and/or have
a material adverse effect on our operations and cash flow.
As
described in greater detail under “ Item 1. Business—Material Agreements—Master Services Agreement with Epiq Scripts ”,
we have entered into a Master Services Agreement and SOW for Epiq Scripts, a related party, 52% owned and controlled by Jacob D. Cohen,
our Chairman and Chief Executive Officer, to provide us pharmacy and compounding services. Pursuant to the Master Services Agreement
and a related SOW, Epiq Scripts agreed to provide pharmacy and related services to us, we agreed to exclusively use Epiq Scripts as the
provider of online fulfillment, specialty compounding, packaging, shipping, dispensing and distribution services relating to products
sold exclusively via our website, that may be prescribed as part of a telehealth consultation on our platform, during the term of the
Master Services Agreement, so long as Epiq Scripts complies with the terms of the Master Services Agreement. The agreement also includes
a 30-day right of first refusal for Epiq Scripts to provide pharmacy services for any new product that Mango may introduce during the
term of the Master Services Agreement.
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Pursuant
to the Master Services Agreement, as amended, Epiq Scripts has certain rights in the event that the Company seeks to obtain pharmaceutical
services in connection with certain Company products in jurisdictions other than the United States, including, without limitation, Mexico
and the United Kingdom, where Epiq Scripts does not currently maintain licenses or permits and/or to terminate Epiq Scripts’ rights
to provide exclusive Pharmaceutical Services in any current state of the United States or Future Jurisdiction where Epiq Scripts may
then be providing Pharmaceutical Services to the Company.
Specifically,
should the Company decide to transfer any services provided by Epiq Scripts in a Current Jurisdiction to another pharmaceutical service
provider, the Company will be required to pay Epiq Scripts a fee of 1% of the total gross sales of all Prescription Products (defined
below) by the Company resulting from the Transferred Services in the Current Jurisdiction, for a period of the lesser of (a) five (5)
years from the date the Company transferred the Transferred Services; and (b) through the end of the term of the Master Services Agreement
(including where applicable, any renewal term). The Non-Use Fee is payable monthly in arrears, for calendar quarters, by the 15th day
following the end of each calendar quarter.
Notwithstanding
the above, the Non-Use Fee shall not apply, and the Company shall not be obligated to pay any Non-Use Fee (a) in the event that the Transferred
Services are provided directly by the Company or a majority-owned subsidiary of the Company; (b) in the event the Company decides to
enter into an agreement with another pharmaceutical service provider to provide Pharmaceutical Services in a Future Jurisdiction; or
(c) in connection with any services provided by any parties in any Future Jurisdictions.
Pursuant
to the Master Services Agreement, as amended, until September 15, 2028, the Company is required to notify Epiq Scripts in writing of
any plans to (a) expand its need for pharmacy services outside of those contemplated by the Master Services Agreement; (b) expand its
need for pharmacy services into a new jurisdiction which Epiq Scripts does not then operate in (including, but not limited to new countries);
or (c) begin providing pharmacy services internally (either through organic growth or acquisition). Thereafter Epiq Scripts has the right
to provide the Company written notice of its intention to provide such services (as described in (a) or (b) above, whereafter the Company
is required to discuss and negotiate such services in good faith with Epiq Scripts for a period of not less than 15 days). Otherwise,
in the event of the occurrence of an event discussed in (c) above, the Company is required to discuss the possibility of Epiq Scripts
either co-operating the pharmacy or providing management services to the Company in good faith for 15 days. In the event after such 15
day period, the Company and Epiq Scripts cannot come to a mutually agreeable agreement, the Company is under no further obligation regarding
the matter set forth in the notice provided to Epiq Scripts.
The
rights and obligations set forth above could have a material adverse effect on the Company, its plans for future products and expansions,
or make such future products or expansion more costly or time consuming.
We
currently exclusively rely, and continue to exclusively rely, on Epiq Scripts, a related party entity, for our pharmacy compounding services.
As
disclosed herein, we have entered into a Master Services Agreement with Epiq Scripts, a related party, 52% owned and controlled by Jacob
D. Cohen, our Chairman and Chief Executive Officer, to operate as our sole and exclusive licensed pharmacy to fulfill and compound our
Compounded Products to customers, assuming our Compounded Products are prescribed by physicians pursuant to our agreements with our Telemedicine
Providers. We currently exclusively rely, and continue to exclusively rely, on Epiq Scripts. We face risks relying on a newly formed
pharmacy with limited operations. Those risks include risks that Epiq Scripts will not be able to follow applicable regulatory guidelines
relating to, will not be able to timely or cost effectively complete, or may not correctly, fulfill, specialty compound, package, ship,
dispense and/or distribute our Pharmaceutical Products. If Epiq Scripts is not able to scale its operations to meet the demand of our
operations, or is unable to undertake any of the actions described above, our business may be materially and adversely affected, we may
need to find a new partner pharmacy, which may charge us more money for its services or may not have as favorable contract terms, we
may be delayed or prevented from selling our Pharmaceutical Products, and may face fines, penalties or litigation. In the event of the
occurrence of any of the above, the value of our securities may decline in value or become worthless.
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The
use of social media and influencers may materially and adversely affect our reputation or subject us to fines or other penalties.
We
use third-party social media platforms as part of our marketing strategy. We also maintain relationships with social media influencers.
As existing e-commerce and social media platforms continue to rapidly evolve and new platforms develop, we expect to maintain a presence
on these existing platforms and expect them to be an important part of our marketing strategy. If we are unable to cost-effectively use
social media platforms as marketing tools, if the social media platforms we use change their policies or algorithms, or if evolving laws
and regulations limit how we can market through these channels, if at all, we may not be able to fully optimize our use of such platforms
and our ability to retain current customers and acquire new customers may suffer. Any such failure could adversely affect our reputation,
revenue, and results of operations.
In
addition, an increase in the use of social media for product promotion and marketing may increase the burden on us to monitor compliance
related thereto, and increase the risk that such materials could contain problematic product or marketing claims in violation of applicable
regulations. For example, in some cases, the Federal Trade Commission has sought enforcement action where an endorsement has failed to
clearly and conspicuously disclose a financial relationship or material connection between an influencer and an advertiser. We do not
control the content of what our influencers post on social media, and if we were held responsible for any false, misleading, or otherwise
unlawful content of their posts or their actions, we could be fined or subjected to other monetary liabilities or required to alter our
practices, which could have an adverse impact on our business, reputation, cash flows and ability to operate.
Negative
commentary regarding our business, or influencers who endorse our products and other third parties who are affiliated with or endorse
us, may also be posted on social media platforms. Influencers with whom we maintain endorsement arrangements could engage in behavior
or use their platforms to communicate with our customers in a manner that reflects poorly on our brand and may be attributed to us or
otherwise adversely affect our reputation. Any such negative commentary could impact our reputation or brand and affect our ability to
attract and retain customers, which could have a material adverse effect on our business and results of operations.
Our
business depends on our brand, and any failure to maintain, protect or enhance our brand, including as a result of events outside our
control, could materially adversely affect our business.
We
believe our future success depends on our ability to maintain and grow the value of the “ Mango ” brand. Maintaining,
promoting and positioning our brand and reputation will depend on, among other factors, the success of our marketing and merchandising
efforts and our ability to provide a consistent, high-quality customer experience. Any negative publicity, regardless of its accuracy,
could materially adversely affect our business. Brand value is based in large part on perceptions of subjective qualities, and any incident
that erodes the loyalty of our customers, including adverse publicity or a governmental investigation or litigation, could significantly
reduce the value of our brand and significantly damage our business.
The
value of our brand also depends on effective customer support to provide a high-quality customer experience, which requires significant
personnel expense. If not managed properly, this expense could impact our profitability. Failure to manage or train our own or outsourced
customer support representatives properly, or our inability to hire sufficient customer support representatives could result in lower-quality
customer support and/or increased customer response times, compromising our ability to handle customer complaints effectively.
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Our
ability to gain and increase market acceptance and generate commercial revenues is subject to a variety of risks, many of which are out
of our control.
Our
Pharmaceutical Products and our future men’s wellness products may not gain or increase market acceptance among physicians, patients,
healthcare payors or the medical community. We believe that the degree of market acceptance and our ability to generate commercial revenues
from such products will depend on a number of factors, including:
●
our
ability to expand the use of our products through targeted patient and physician education;
●
competition
and timing of market introduction of competitive products;
●
quality,
safety and efficacy in the approved setting;
●
prevalence
and severity of any side effects, including those of the components of our products;
●
emergence
of previously unknown side effects, including those of the generic components of our products;
●
potential
or perceived advantages or disadvantages over alternative treatments;
●
the
convenience and ease of purchasing the product, as perceived by potential patients;
●
strength
of sales, marketing and distribution support;
●
price,
both in absolute terms and relative to alternative treatments;
●
the
effectiveness of any future collaborators’ sales and marketing strategies;
●
the
effect of current and future healthcare laws;
●
availability
of coverage and reimbursement from government and other third-party payors;
●
recommendations
for prescribing physicians to complete certain educational programs for prescribing drugs;
●
the
willingness of patients to pay out-of-pocket in the absence of government or third-party coverage; and
●
product
labeling, product insert, or new studies or trial requirements of the FDA or other regulatory authorities.
Our
Pharmaceutical Products and/or future products may fail to achieve market acceptance or generate significant revenue to achieve sustainable
profitability. In addition, our efforts to educate the medical community and third-party payors on the safety and benefits of our drugs
may require significant resources and may not be successful.
We
may be unable to scale our operations fast enough to bring down our cost of sales and generate revenues sufficient to support our operations.
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. If we are unable to grow our business fast enough to
take advantage of these economies of scale, our operations may suffer, and we may not be profitable.
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Economic
downturns or a change in consumer preferences, perception and spending habits has in the past, and could in the future, limit consumer
demand for our products and negatively affect our future business.
The
products that we sell (including our Pharmaceutical Products) and plan to sell in the future have been in the past, and may in the future
be, adversely affected from time to time by economic downturns that impact consumer spending, including discretionary spending. Future
economic conditions such as employment levels, business conditions, housing starts, market volatility, interest rates, inflation rates,
energy and fuel costs and tax rates, or our actions in response to these conditions, such as price increases, could reduce consumer spending
or change consumer purchasing habits.
Our
performance depends significantly on factors that may affect the level and pattern of consumer spending in the markets in which we operate.
Such factors include consumer preference, consumer confidence, consumer income, consumer perception of the safety and quality of our
future products and shifts in the perceived value for our products relative to alternatives. A general decline in the consumption of
our future products could occur at any time as a result of change in consumer preference, perception, confidence and spending habits,
including an unwillingness to pay a premium or an inability to purchase our products due to financial hardship or increased price sensitivity,
which may be exacerbated by inflationary pressures, interest rates, and economic uncertainty. If consumer preferences shift away from
our products, our business, financial condition and results of operations could be adversely affected.
The
success of our products depends on a number of factors including our ability to accurately anticipate changes in market demand and consumer
preferences, our ability to differentiate the quality of our future products from those of our competitors, and the effectiveness of
our marketing and advertising campaigns for our products. We may not be successful in identifying trends in consumer preferences and
developing products that respond to such trends in a timely manner. We also may not be able to effectively promote our products by our
marketing and advertising campaigns and gain market acceptance. If our products fail to gain market acceptance, are restricted by regulatory
requirements or have quality problems, we may not be able to fully recover costs and expenses incurred in our operation, and our business,
financial condition, results of operations and prospects could be adversely affected.
We
rely upon independent third-party transportation providers for all of our product shipments and are subject to increased shipping costs
as well as the potential inability of our third-party transportation providers to deliver on a timely basis.
We
rely upon independent third-party transportation providers for all of our product shipments, including shipments from our related party
pharmacy to our customers. Our utilization of these third-party delivery services for shipments is subject to risks which may impact
a shipping company’s ability to provide delivery services that adequately meet our shipping needs, including risks related to employee
strikes, labor and capacity constraints, port security considerations, trade policy changes or restrictions, military conflicts, acts
of terrorism, accidents, natural disasters and inclement weather. Any interruption in service provided by our shipping companies could
cause temporary disruptions in our business, a loss of sales and profits, and other material adverse effects. In addition, we are subject
to increased shipping costs when fuel prices increase, as we use expedited means of transportation such as air freight. If we change
the shipping company we use, we could face logistical difficulties that could adversely affect deliveries, and we would incur costs and
expend resources in connection with such change.
The
failure of our Telemedicine Providers to attract and retain physicians in a competitive labor market could limit our ability to execute
our growth strategy, resulting in a slower rate of growth.
The
success of our wellness business will depend on the ability of our Telemedicine Providers and any future contracted telemedicine services
provider(s) to continue to recruit and retain a sufficient number of qualified licensed doctors. Although we believe such provider(s)
will have an effective recruitment process, there is no assurance that such provider(s) will be able to secure arrangements with sufficient
numbers of licensed doctors or retain the services of such practitioners. If our Telemedicine Providers or any provider(s) we engage
in the future, experience delays or shortages in obtaining access to qualified physicians, we would be unable to operate and may be forced
to seek alternative arrangements which could be more costly or may be forced to suspend our business operations.
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Our
business could be adversely affected if physicians were classified as employees of the Telemedicine Providers instead of independent
contractors.
Our
Telemedicine Providers typically engage physicians that perform services through our platform as independent contractors. The Telemedicine
Providers believe that the physicians are independent contractors because, among other things, they can choose whether, when, and where
to provide services on our platform and are free to provide services on our competitors’ platforms. Nevertheless, recent legislative
and judicial activity have in some jurisdictions created more restrictive standards or enforcement uncertainty with respect to the classification
of workers within certain industries. The Telemedicine Providers may not be successful in defending the independent contractor status
of physicians in some or all jurisdictions in which we and/or they operate. Furthermore, the costs associated with defending, settling,
or resolving pending and future lawsuits (including demands for arbitration) relating to the independent contractor status of physicians
could be material to the Telemedicine Providers. Foreign, state, and local laws governing the definition or classification of independent
contractors, or changes thereto, or judicial decisions regarding independent contractor classification, could require classification
of physicians as employees (or workers or quasi-employees where those statuses exist) of the Telemedicine Providers. If the Telemedicine
Providers are required to classify physicians as employees (or as workers or quasi-employees where applicable), it could result in significant
additional expenses, potentially including expenses associated with the application of wage and hour laws (including minimum wage, overtime,
and meal and rest period requirements), employee benefits, social security contributions, taxes, and penalties. Further, any such reclassification
could add significant complexity to our business model and could force us to have to modify or renegotiate our relationships with the
Telemedicine Providers, which may not be possible on mutually agreeable terms, and could have an adverse effect on our business, financial
condition, and results of operations.
Disruption
in our global supply chain could negatively impact our business.
The
compounds found in the products we sell are sourced from a wide variety of vendors, and any future disruption in our supply chain or
inability to find qualified vendors and access compounds that meet requisite quality and safety standards in a timely and efficient manner
could adversely impact our business. While we have not experienced material supply chain issues to date, the loss or disruption of such
supply arrangements for any reason, including as a result of ongoing conflict arising out of the Russian invasion of Ukraine and the
hostilities and conflict in the Middle East, other acts of war or terrorism, trade sanctions, inflation, tariffs, health epidemics or
pandemics, labor disputes, loss or impairment of key manufacturing sites, inability to procure sufficient raw materials, quality control
issues, ethical sourcing issues, a supplier’s financial distress, natural disasters, looting or other external factors over which
we have no control, could interrupt product supply and, if not effectively managed and remedied, have a material adverse impact on our
business, results of operations and financial condition.
Additionally,
any major changes in tax or trade policy, such as the imposition of additional tariffs or duties on imported products, or trade sanctions,
between the U.S. and countries from which we or our vendors source merchandise, directly or indirectly, could require us to take certain
actions, such as raising prices on our offerings or seeking alternative sources of supply from vendors with whom we have less familiarity,
which could adversely affect our reputation, revenue, and our results of operations.
If
we are unable to maintain or enter into future agreements with suppliers or our suppliers fail to supply us with our Compounded Products
ingredients or any other potential future men’s wellness products, we may experience delays in selling our products.
We
may not be successful in maintaining or entering into new supply agreements on reasonable terms or at all or that we or our suppliers
will be able to obtain or maintain the necessary regulatory approvals or state and federal controlled substances registrations for current
or potential future suppliers in a timely manner or at all. If we are unable to obtain a sufficient quantity of active pharmaceutical
ingredients manufactured at a facility that is registered and listed with the FDA and required to produce products, there could be a
delay in producing products, which could adversely affect our product sales and operating results materially, which could significantly
harm our business. This has not occurred to date.
We
currently do not have any manufacturing facilities and instead rely on third parties for the supply of our products (currently just Epiq
Scripts, which is a related party), as well as for the supply of materials. However, we cannot be certain that we or our suppliers will
be able to obtain or maintain the necessary regulatory approvals or registrations for these suppliers in a timely manner or at all.
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Our
business is exposed to risks associated with credit card and other online payment chargebacks and fraud.
A
majority of our revenue is, and is expected to be, processed through credit cards and other online payments. If we experience refunds
or chargebacks, our processors could require us to create reserves, increase fees or terminate contracts with us, which would have an
adverse effect on our financial condition. Our failure to limit fraudulent transactions conducted on our website, such as through the
use of stolen credit card numbers, could also subject us to liability and adversely impact our reputation. Under credit card association
rules, penalties may be imposed at the discretion of the association for inadequate fraud protection. Any such potential penalties would
be imposed on our credit card processor by the association. However, we face the risk that we may fail to maintain an adequate level
of fraud protection and that one or more credit card associations or other processors may, at any time, assess penalties against us or
terminate our ability to accept credit card payments or other form of online payments from customers, which would have a material adverse
effect on our business, financial condition and operating results.
We
could also incur significant fines or lose our ability to give customers the option of using credit cards to pay for our products if
we fail to follow payment card industry data security standards, even if there is no compromise of customer information. Although we
believe that we operate in compliance with payment card industry data security standards, it is possible that at times we may not be
in full compliance with these standards. Accordingly, we could be fined, which could impact our financial condition, or our ability to
accept credit and debit cards as payment could be suspended, which would cause us to be unable to process payments using credit cards.
If we are unable to accept credit card payments, our business, financial condition and operating results may be adversely affected.
In
addition, we could be liable if there is a breach of the payment information. Online commerce and communications depend on the secure
transmission of confidential information over public networks. We rely on encryption and authentication technology to authenticate and
secure the transmission of confidential information, including cardholder information. However, this technology may not prevent breaches
of the systems we use to protect cardholder information. In addition, some of our contracting parties may also collect or possess information
about our customers, and we may be subject to litigation or our reputation may be harmed if our contracting parties fail to protect our
customers’ information or if they use it in a manner inconsistent with our policies and practices. Data breaches can also occur
as a result of non-technical issues. Under contracts with processors, if there is unauthorized access to, or disclosure of, credit card
information we store, we could be liable to the credit card issuing banks for their cost of issuing new cards and related expenses.
Security
breaches, loss of data and other disruptions could compromise sensitive information related to our business or customers, or prevent
us from accessing critical information and expose us to liability, which could adversely affect our business and our reputation.
In
the ordinary course of our business, we collect, store, use and disclose sensitive data, including health information and other types
of personally identifiable information, or PII. We also process and store, and use additional third parties to process and store, confidential
and proprietary information such as intellectual property and other proprietary business information, including that of our customers,
providers and contracting parties.
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Security
breaches of this infrastructure, including physical or electronic break-ins, computer viruses, attacks by hackers and similar breaches,
and employee or contractor error, negligence or malfeasance, can create system disruptions, shutdowns or unauthorized disclosure or modifications
of information, causing sensitive, confidential or proprietary information to be accessed or acquired without authorization or to become
publicly available. Because of the nature of the sensitive, confidential and proprietary information that we expect to collect, store,
transmit, and otherwise process, the security of our technology platform and other aspects of our services, including those provided
or facilitated by our third-party service providers, will be important to our operations and business strategy. Measures taken to protect
our systems, those of our third-party service providers, or sensitive, confidential and proprietary information that we or our third-party
service providers process or maintain, may not adequately protect us from the risks associated with the collection, storage and transmission
of such information. A security breach or privacy violation that leads to disclosure or unauthorized use or modification of, or that
prevents access to or otherwise impacts the confidentiality, security, or integrity of, sensitive, confidential, or proprietary information
we or our third-party service providers maintain or otherwise process, could harm our reputation, compel us to comply with breach notification
laws, and cause us to incur significant costs for remediation, fines, penalties, notification to individuals and governmental authorities,
implementation of measures intended to repair or replace systems or technology and to prevent future occurrences, potential increases
in insurance premiums, and forensic security audits or investigations. As a result, a security breach or privacy violation could result
in increased costs or loss of revenue.
Any
actual or suspected security breach or other compromise of our security measures or those of our third-party vendors, whether as a result
of hacking efforts, denial-of-service attacks, viruses, malicious software, break-ins, phishing attacks, social engineering or otherwise,
could harm our reputation and business, damage our brand and make it harder to retain existing customers or acquire new ones, require
us to expend significant capital and other resources to address the breach, and result in a violation of applicable laws, regulations
or other legal obligations. Our insurance policies may not cover, or may not be adequate to reimburse us for, losses caused by any such
security breach.
We
rely on email and other messaging services to connect with our existing and potential customers. Our customers may be targeted by parties
using fraudulent spoofing and phishing emails to misappropriate passwords, payment information or other personal information or to introduce
viruses through Trojan horse programs or otherwise through our customers’ computers, smartphones, tablets or other devices. Despite
our efforts to mitigate the effectiveness of such malicious email campaigns through product improvements, spoofing and phishing may damage
our brand and increase our costs. Any of these events or circumstances could materially adversely affect our business, financial condition
and operating results.
As
of the date of this filing, we are not aware of the occurrence of any data breaches or other security related issues.
We
may experience fluctuations in our tax obligations and effective tax rate, which could adversely affect our business, results of operations,
and financial condition.
We
are subject to taxes in every jurisdiction in which we operate. We record tax expense based on current tax liabilities and our estimates
of future tax liabilities, which may include reserves for estimates of probable settlements of tax audits. At any one-time, multiple
tax years are subject to audit by various taxing jurisdictions. The results of these audits and negotiations with taxing authorities
may affect the ultimate settlement of these issues. Further, our effective tax rate in a given financial statement period may be materially
impacted by changes in tax laws, changes in the mix and level of earnings by taxing jurisdictions, or changes to existing accounting
rules or regulations. Fluctuations in our tax obligations and effective tax rate could adversely affect our business, results of operations,
and financial condition.
If
we become subject to product liability claims, we may be required to pay damages that exceed our insurance coverage, if any.
Our
products are subject to risks for product liability claims due to inherent potential side effects. We may be unable to obtain or maintain
product liability coverage. A product liability claim in excess of, or excluded from, our insurance coverage which currently covers exposure
to product liability claims, both technology products and physical products, would have to be paid out of cash reserves and could have
a material adverse effect upon our business, financial condition and results of operations. Product liability insurance is expensive
even with large self-insured retentions or deductibles, difficult to maintain, and current or increased coverage may not continue to
be available on acceptable terms, if at all.
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If
we cannot successfully defend ourselves against a product liability claim, we may incur substantial liabilities. Regardless of merit
or eventual outcome, liability claims may result in:
●
injury
to our reputation;
●
costs
of defending the claim and/or related litigation;
●
cost
of any potential adverse verdict;
●
substantial
monetary awards to patients or other claimants; and
●
the
inability to commercialize our products.
Damages
awarded in a product liability action could be substantial and could have a negative impact on our financial condition. Whether or not
we were ultimately successful in product liability litigation, such litigation would consume substantial amounts of our financial and
managerial resources, and might result in adverse publicity, all of which would impair our business.
For
example, a 2014 study published in The Journal of the American Medical Association determined that Sildenafil (the active ingredient
in Viagra and one of the ingredients we alternatively use, together with Sildenafil in our Mango ED product) may be associated with a
higher risk of developing melanoma. The study evaluated data from more than 25,000 men who used Sildenafil and found that Sildenafil
use was significantly associated with an increased risk of subsequent melanoma, after considering other risk factors. It is possible
that the ingredients we use in our Compounded Products (including our Mango ED product, which is made with Sildenafil as an alternative
to Tadalafil) or any other products we sell, including PRIME, could be found to result in increases in the likelihood of developing cancer
or other diseases, which could subject us to litigation, penalties or recalls, all of which could have a material adverse effect on our
operations and cause the value of our securities to decline in value or become worthless. Furthermore, our use of Sildenafil in our products
could subject us to litigation, penalties or recalls, all of which could have a material adverse effect on our operations and cause the
value of our securities to decline in value or become worthless.
Disruptions
in our data and information systems could harm our reputation and our ability to run our business.
We
rely extensively on data and information systems for our supply chain, financial reporting, human resources and various other operations,
processes and transactions. Furthermore, a significant portion of the communications between us, our suppliers and customers depend on
information technology. Our data and information systems are subject to damage or interruption from power outages, computer and telecommunications
failures, computer viruses, security breaches (including breaches of our transaction processing or other systems that could result in
the compromise of confidential customer data), catastrophic events, data breaches and usage errors by our employees or third-party service
providers. Our data and information technology systems may also fail to perform as we anticipate, and we may encounter difficulties in
adapting these systems to changing technologies or expanding them to meet the future needs of our business. If our systems are breached,
damaged or cease to function properly, we may have to make significant investments to fix or replace them, suffer interruptions in our
operations, incur liability to our customers and others or face costly litigation, and our reputation with our customers may be harmed.
We also rely on third parties for a majority of our data and information systems, including for third-party hosting and payment processing.
If these facilities fail, or if they suffer a security breach or interruption or degradation of service, a significant amount of our
data could be lost or compromised and our ability to operate our business and deliver our product offerings could be materially impaired.
In addition, various third parties, such as our suppliers and payment processors, also rely heavily on information technology systems,
and any failure of these systems could also cause loss of sales, transactional or other data and significant interruptions to our business.
Any material interruption in the data and information technology systems we rely on, including the data or information technology systems
of third parties, could materially adversely affect our business, financial condition and operating results.
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Risks
Related to Legal, Regulatory and Government
We
incur significant costs to ensure compliance with U.S. and Nasdaq reporting and corporate governance requirements.
We
incur significant costs associated with our public company reporting requirements and with applicable U.S. and Nasdaq corporate governance
requirements, including requirements under the Sarbanes-Oxley Act of 2002 and other rules implemented by the SEC and Nasdaq. All of these
applicable rules and regulations significantly increase our legal and financial compliance costs and make some activities more time-consuming
and costly. These applicable rules and regulations also make it more difficult and more expensive for us to retain director and officer
liability insurance and as a result, we may be required to accept reduced policy limits and coverage or incur substantially higher costs
to obtain the same or similar coverage. As a result, it may be more difficult for us to attract and retain qualified individuals to serve
on our Board of Directors or as executive officers.
If
we fail to comply with government laws and regulations it could have a materially adverse effect on our business.
The
health care industry is subject to extensive federal, state and local laws and regulations relating to licensure, conduct of operations,
ownership of facilities, addition of facilities and services, payment for services and prices for services that are extremely complex
and for which, in many instances, the industry does not have the benefit of significant regulatory or judicial interpretation. We exercise
care in structuring our arrangements with physicians and other referral sources to attempt to comply in all material respects with applicable
laws. We also take such laws into account when planning future marketing and other activities, and expect that our operations are in
compliance with applicable laws. The laws, rules and regulations described above are complex and subject to interpretation. In the event
of a determination that we are in violation of such laws, rules or regulations, or if further changes in the regulatory framework occur,
any such determination or changes could have a material adverse effect on our business. There can be no assurance however that we will
not be found in noncompliance in any particular situation.
Separately,
Federal law limits compounded drugs that are “ essentially copies ” of commercially available FDA approved drugs, including
those with the same route of administration. If our Compounded Products, or any future products we may choose to market in the future
are deemed to be “ essentially copies ” of commercially available FDA approved drugs we would be prohibited from compounding
such drugs and would be unable to sell our Compounded Products or future products. If that were to occur, we would need to change our
business plan which would require substantial additional expenses and would have a material adverse effect on our cash flows and the
value of our securities.
Marketing
activities for our Pharmaceutical Products are subject to strict governmental regulation which may limit our ability to market or promote
such product.
Our
business model depends on qualifying for certain statutory exemptions for drugs that are compounded by pharmacies in accordance with
applicable requirements. Pharmacy compounding is also subject to state oversight and regulation. Federal requirements include obtaining
individual prescriptions establishing that the compounded drug is necessary for each drug prescribed for each of our customers. Federal
law also limits compounded drugs that are “ essentially copies ” of commercially available FDA approved drugs, including
those with the same route of administration. These restrictions will limit our ability to market compounded drugs that have the same
active ingredients and route of administration as FDA-approved drugs, unless the compounded version offers a significant difference that
the prescriber determines is necessary for each individual patient.
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The
FDA also has the authority to impose significant restrictions on approved products through regulations on advertising, promotional and
distribution activities. In particular, the FDA will object to any promotional activity (including through testimonials and surrogates)
that is “ false or misleading in any particular, ” including the failure to disclose material facts. For example, the
FDA will expect adequate substantiation for an efficacy claim, which would require substantial evidence derived from adequate and well-controlled
clinical trials. 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. If our products are marketed in contradiction with FDA laws and regulations,
the FDA may issue warning letters that require specific remedial measures to be taken, as well as an immediate cessation of the impermissible
conduct, resulting in adverse publicity. The FDA may also require that all future promotional materials receive prior agency review and
approval before use. Certain states have also adopted regulations and reporting requirements surrounding the promotion of pharmaceuticals.
Failure by us or any of our collaborators to comply with state requirements may affect our ability to promote or sell future products
in certain states. This, in turn, could have a material adverse impact on our financial results and financial condition and could subject
us to significant liability, including civil and administrative remedies as well as criminal sanctions.
These restrictions may be more
burdensome for compounded products as compared with FDA approved products because the latter have substantial evidence of safety and effectiveness,
which will limit our ability to compete against the sale of comparable FDA-approved products.
Evolvin g
government regulations and enforcement activities may require increased costs or adversely affect our results of operations.
Our
operations may be subject to direct and indirect adoption, expansion or reinterpretation of various laws and regulations. Compliance
with these evolving laws, regulations and interpretations may require us to change our practices at an undeterminable and possibly significant
initial monetary and annual expense. These additional monetary expenditures may increase future overhead, which could have a material
adverse effect on our results of operations. There could also be laws and regulations applicable to our business that we have not identified
or that, if changed, may be costly to us, and we cannot predict all the ways in which implementation of such laws and regulations may
affect us.
Additionally,
the introduction of new products may require us to comply with additional, yet undetermined, laws and regulations. Compliance may require
obtaining appropriate federal, state, or local licenses or certificates, increasing our security measures and expending additional resources
to monitor developments in applicable rules and ensure compliance. The failure to adequately comply with these future laws and regulations
may delay or possibly prevent our products from being offered to customers, which could have a material adverse effect on our business,
financial condition, and results of operations.
Failure
to comply with federal, state and foreign laws and regulations relating to privacy, data protection and consumer protection, or the expansion
of current or the enactment of new laws or regulations relating to privacy, data protection and consumer protection, could adversely
affect our business and our financial condition.
A
variety of federal, state and foreign laws and regulations govern the collection, use, retention, sharing and security of consumer data.
Laws and regulations relating to privacy, data protection and consumer protection are evolving and subject to potentially differing interpretations.
These requirements may be interpreted and applied in a manner that is inconsistent from one jurisdiction to another or may conflict with
other rules or our practices. As a result, our practices may not comply with all such laws, regulations, requirements and obligations.
Any failure, or perceived failure, by us to comply with any federal, state or foreign privacy or consumer protection-related laws, regulations,
industry self-regulatory principles, industry standards or codes of conduct, regulatory guidance, orders to which we may be subject or
other legal obligations relating to privacy or consumer protection could adversely affect our reputation, brand and business, and may
result in claims, investigations, proceedings or actions against us by governmental entities or others or other liabilities or require
us to change our operations.
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We
collect, store, process, and use personal information and other customer data, and will rely on third parties that are not directly under
our control to manage certain of these operations and to collect, store, process and use payment information. Our customers’ personal
information may include names, addresses, phone numbers, email addresses, payment card data, and payment account information, as well
as other information. Due to the volume and sensitivity of the personal information and data we and these third parties manage, the security
features of our information systems are critical. If our security measures, some of which are managed by third parties, are breached
or fail, unauthorized persons may be able to access sensitive customer data, including payment card data. If we or our independent service
providers or business partners experience a breach of systems that collect, store or process our members’ and customers’
sensitive data, our brand could be harmed, sales of our products could decrease, and we could be exposed to claims, losses, administrative
fines, litigation or regulatory and governmental investigations and proceedings. Any such claim, investigation, proceeding or action
could hurt our reputation, brand and business, force us to incur significant expenses in defense of such proceedings, distract our management,
increase our costs of doing business, result in a loss of customers and suppliers and may result in the imposition of monetary penalties
and administrative fines. Depending on the nature of the information compromised, we may also have obligations to notify users, law enforcement,
or payment companies about the incident and may need to provide some form of remedy, such as refunds, for the individuals affected by
the incident.
Privacy
laws, rules, and regulations are constantly evolving in the United States and abroad and may be inconsistent from one jurisdiction to
another. We expect that new industry standards, laws and regulations will continue to be proposed regarding privacy, data protection
and information security in many jurisdictions, including privacy acts previously adopted by 20 states as of the date of this Report,
including the states of California, Colorado, Connecticut, Delaware, Florida, Indiana, Iowa, Kentucky, Maryland, Montana, Minnesota,
Montana, New Hampshire, Nebraska, New Jersey, Oregon, Rhode Island, Tennessee, Texas, Utah, and Virginia, certain of which are already
effective, and certain of which become effective during 2025 and 2026. We cannot yet determine the impact such future laws, regulations
and standards may have on our business. Complying with these evolving obligations is costly. For instance, expanding definitions and
interpretations of what constitutes “ personal data ” (or the equivalent) within the United States and elsewhere may
increase our compliance costs. Any failure to comply could give rise to unwanted media attention and other negative publicity, damage
our customer and consumer relationships and reputation, and result in lost sales, claims, administrative fines, lawsuits or regulatory
and governmental investigations and proceedings and may harm our business and results of operations.
Our
Compounded Products have not been, and will not be, approved by the FDA. The use of such products may cause serious side effects which
could subject us to material litigation, damages and penalties.
Our
Compounded Products have not been, and will not be, approved by the FDA. It is compounded using bulk drug substances and as such, we
believe it is exempt from specific FDA approval, provided that it is compounded in accordance with statutory requirements. Because compounded
drugs are not FDA-approved, the FDA does not verify their safety, effectiveness, or quality before they are marketed. In addition, poor
compounding practices can result in serious drug quality problems, such as contamination or a drug that contains too much or too little
active ingredient, among other possible quality deficiencies.
We
are not aware of any clinical studies involving the administration of Sildenafil or Tadalafil sublingually at the doses we intend to
provide patients, or the compounding of Sildenafil or Tadalafil, Oxytocin, and L-arginine to treat ED, as is contemplated by our Mango
ED products. We are also not aware of any clinical studies involving the administration of Minoxidil and Finasteride sublingually at
the dose we provide patients, or the compounding of Minoxidil, Finasteride, Vitamin D3 and Biotin, to attempt to treat hair loss, as
is contemplated by our Mango GROW product. We are also not aware of any clinical studies involving the administration of Enclomiphene
Citrate, Pregnenolone, and DHEA sublingually at the dose we provide patients, or the compounding of these ingredients to attempt to manage
and balance hormones, as is contemplated by our Mango MOJO product. We are also not aware of any clinical studies involving the administration
of Semaglutide sublingually at the dose we provide patients, or the compounding of Semaglutide with Vitamin B6 to attempt to assist with
weight management, as is contemplated by our Mango SLIM product.
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Because
our Compounded Products have not been, and will not be, approved by the FDA, our products have 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. For
example, in October 2012, a pharmacy in Massachusetts shipped compounded drugs that were contaminated with a fungus throughout the country,
and these drugs were injected into patients’ spines and joints. More than 750 people in 20 states developed fungal infections,
and more than 60 people died. This type of action could have a significant negative impact on our brand name, results of operations and
cash flows, and result in us having to cease selling products, curtailing our business plan, or seeking bankruptcy protection.
The
main ingredients of our Compounded Products are publicly disclosed and are being specially compounded for the customer by a pharmacist
with a physician’s prescription, and as a result, our Compounded Products formula can be replicated by other companies.
Because
our Compounded Products are being specially compounded for customers by a pharmacist with a physician’s prescription and because
the ingredients for our Compounded Products are publicly disclosed, these product formulas can be replicated by other companies. As a
result, competitors, including those with greater resources, marketing, and brand recognition, may compete against us in the future using
our exact product ingredients or variations thereof. We may be unable to distinguish our Compounded Products from copycat products and
may not be able to differentiate our product from competitors in the marketplace. As a result, we may fail to obtain a significant market
share, or may lose any market share we may obtain in the future, may be unable to compete with competitors, and may be forced to abandon
or curtail our business plan, which could cause the value of our shares to decline in value or become worthless.
Our
Compounded Products need to be compounded by licensed pharmacists who are subject to risks regarding applicable exemptions from the FFDCA
Act.
Section
503A of the FFDCA describes the conditions under which compounded human drug products are exempt from the FFDCA sections on FDA approval
prior to marketing, current good manufacturing practice requirements, and labeling with adequate directions for use. One of these conditions
is that the drugs must be compounded based on the receipt of valid patient-specific prescriptions. Our Compounded Products needs to be
compounded by licensed pharmacists, after being prescribed by a licensed physician. Licensed pharmacists who compound drug products in
accordance with Section 503A of the FFDCA are not required to comply with CGMP requirements and the drugs that they compound are not
required to be approved by the FDA, provided that the compounding complies with applicable requirements. Therefore, the FDA is often
not aware of potential problems with compounded drug products or compounding practices unless it receives a complaint, such as a report
of a serious adverse event or visible contamination. As such, the compounding of our products is subject to limited FDA oversight, which
could lead to such products not being compounded safely and could lead to product recalls and litigation which could have a significant
negative impact on our brand name, results of operations and cash flows, and result in us having to cease selling products, curtailing
our business plan, or seeking bankruptcy protection. Neither we, nor our representatives have had any conversations with the FDA staff
regarding whether our Compounded Products can be sold pursuant to Section 503A of the FFDCA Act and future conversations with the FDA
may result in the FDA staff raising issues with such sales pursuant to Section 503A of the FFDCA, requiring certain pre-requisites or
changes to our current business plan, which may be costly or time consuming, and/or may result in us being prohibited from selling our
Compounded Products pursuant to Section 503A of the FFDCA Act. We also face risks that the compounding of our products does not fall
within the exemption from the FFDCA provided by Section 503A thereof. For example, if the FDA determined that any of our products are
essentially a copy of an FDA approved product, we would be severely limited in our ability to compound such a product. If any of the
above were to apply, we may need to change our business plan or compounding activities, which could force us to curtail our business
plan or expend significant additional resources to obtain FFDCA or FDA approval for our products.
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Notwithstanding
the above, under relevant FDA guidance, the FDA generally does not consider a compounded drug to be “ essentially a copy ”
of a commercially available drug if the compounded drug has a different route of administration as compared with the approved alternative,
and our Compounded Products are for a different route of administration (e.g., sublingual). In addition, we do not expect that we will
be deemed to have engaged in such “ copying ”, because our Compounded Products are based on a prescriber’s determination
for each patient that the change associated with the compounded product (our Compounded Products) produces for the patient a significant
difference as compared with the commercially available drug product. Under relevant FDA guidance, the FDA does not consider a compounded
drug “ essentially a copy ” if a prescriber determines that there is a change, made for an identified individual patient,
which produces for that patient a significant difference from the commercially available product.
Health
care services, including arrangements with health care professionals, are heavily regulated at the state level, and the laws and regulations
may be changed or subject to new interpretations.
Each
state separately licenses health care professionals and determines when and under what conditions they may interact with and provide
services to patients. Telehealth consultations initiated through our platform must be offered in accordance with the laws and regulations
of the state where a patient is located, which may include laws that restrict the corporate practice of medicine and fee splitting. Each
state’s laws are subject to legislative and regulatory changes, as well as judicial interpretations, and future changes or interpretations
of state laws restricting the corporate practice of medicine and fee splitting could adversely affect the permissibility of (a) our relationship
with the Telemedicine Providers; and/or (b) the Telemedicine Providers’ relationships with their contracted physicians. If our
relationship with the Telemedicine Providers and/or the Telemedicine Providers’ relationships with their contracted physicians
needed to be restructured in light of any such adverse changes or interpretations, that restructuring could negatively affect our ability
to connect consumers with medical providers in certain states, and thus those customers’ ability to ultimately receive our products.
We
do not have a pharmacy and depend on a related party to compound our Compounded Products and other potential future men’s wellness
products.
We
rely on a related party pharmacy for the manufacture of our Mango product and will rely on this pharmacy or others for any potential
future men’s wellness products we market and we cannot assure you that they will be successful. This subjects us to a number of
risks, including the following:
●
we
may not be able to control the commercialization of our products, including the amount, timing and quality of resources that our
contracting parties may devote to our products;
●
our
contracting parties may experience financial, regulatory or operational difficulties, which may impair their ability to fulfill their
contractual obligations;
●
business
combinations or significant changes in a contracting parties’ business strategy may adversely affect a contracting party’s
willingness or ability to perform their obligations under any arrangement;
●
legal
disputes or disagreements may occur with one or more of our contracting parties or between our contracting parties and our suppliers
or former contracting parties; and
●
a
contracting party could independently move forward with a competing product developed either independently or in collaboration with
others, including with one of our competitors.
If
any of our contracting parties fail to fulfill their future contractual obligations, our business may be negatively affected and we may
receive limited or no revenues under our agreements with them. See also the risk factor, “ The related party pharmacy we have
entered into an agreement with may not receive licenses in all of the 50 United States to provide national coverage for us to sell our
Pharmaceutical Products and future products ” below.
Our
use and disclosure of personally identifiable information, including health information, is subject to federal and state privacy and
security regulations, and our failure to comply with those regulations or to adequately secure the information we hold could result in
significant liability or reputational harm and, in turn, a material adverse effect on our client base and revenue.
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Numerous
state and federal laws and regulations govern the collection, dissemination, use, privacy, confidentiality, security, availability and
integrity of personally identifiable information, or PII, including protected health information, or PHI. These laws and regulations
include the Health Information Portability and Accountability Act of 1996 (“ HIPAA ”), as amended by the Health Information
Technology for Economic and Clinical Health Act, or HITECH, and their implementing regulations (referred to collectively as “ HIPAA ”).
HIPAA establishes a set of basic national privacy and security standards for the protection of PHI. HIPAA requires us to develop and
maintain policies and procedures with respect to PHI that is used or disclosed, including the adoption of administrative, physical and
technical safeguards to protect such information. HIPAA imposes mandatory penalties for certain violations. Penalties for violations
of HIPAA and its implementing regulations start at $100 per violation and are not to exceed $50,000 per violation, subject to a cap of
$1.5 million for violations of the same standard in a single calendar year. However, a single breach incident can result in violations
of multiple standards. HIPAA also authorizes state attorneys general to file suit on behalf of their residents. Courts are able to award
damages, costs and attorneys’ fees related to violations of HIPAA in such cases. While HIPAA does not create a private right of
action allowing individuals to sue us in civil court for violations of HIPAA, its standards have been used as the basis for duty of care
in state civil suits such as those for negligence or recklessness in the misuse or breach of PHI. In addition, HIPAA mandates that the
Secretary of Health and Human Services, or HHS, conduct periodic compliance audits of HIPAA covered entities or business associates for
compliance with the HIPAA Privacy and Security Standards. It also tasks HHS with establishing a methodology whereby harmed individuals
who were the victims of breaches of unsecured PHI may receive a percentage of the Civil Monetary Penalty fine paid by the violator. HIPAA
further requires that patients be notified of any unauthorized acquisition, access, use or disclosure of their unsecured PHI that compromises
the privacy or security of such information, with certain exceptions related to unintentional or inadvertent use or disclosure by employees
or authorized individuals. HIPAA specifies that such notifications must be made “ without unreasonable delay and in no case later
than 60 calendar days after discovery of the breach. ” If a breach affects 500 patients or more, it must be reported to HHS
without unreasonable delay, and HHS will post the name of the breaching entity on its public web site. Breaches affecting 500 patients
or more in the same state or jurisdiction must also be reported to the local media. If a breach involves fewer than 500 people, the covered
entity must record it in a log and notify HHS at least annually.
Numerous
other federal and state laws protect the confidentiality, privacy, availability, integrity and security of PII, including PHI. These
laws in many cases are more restrictive than, and may not be pre-empted by, the HIPAA rules and may be subject to varying interpretations
by courts and government agencies, creating complex compliance issues for us and our clients and potentially exposing us to additional
expense, adverse publicity and liability.
Because
of the extreme sensitivity of the PII we store and transmit, the security features of our technology platform are very important. If
our security measures are breached or fail, unauthorized persons may be able to obtain access to sensitive client data, including HIPAA-regulated
PHI. As a result, our reputation could be severely damaged, adversely affecting client confidence. In addition, we could face litigation,
damages for contract breach, penalties and regulatory actions for violation of HIPAA and other applicable laws or regulations and significant
costs for remediation, notification to individuals and for measures to prevent future occurrences. Any potential security breach could
also result in increased costs associated with liability for stolen assets or information, repairing system damage that may have been
caused by such breaches, incentives offered to clients in an effort to maintain our business relationships after a breach and implementing
measures to prevent future occurrences, including organizational changes, deploying additional personnel and protection technologies,
training employees and engaging third-party experts and consultants.
Risks
Related to Related Party Relationships and Transactions and Our Management
We
depend heavily on our senior management, including our Chief Executive Officer, who may have a conflict of interest with regard to various
matters. The ability of certain key employees to devote adequate time to us is critical to the success of our business, and failure to
do so may adversely affect our revenues and as a result could materially adversely affect our business, financial condition and results
of operations.
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We
must retain the services of our key employees and strategically recruit and hire new talented employees. Our future business and results
of operations depend in significant part upon the continued contributions of our senior management personnel, particularly our Chairman
and Chief Executive Officer, Jacob D. Cohen. Mr. Cohen is currently a co-Manager and 52% owner of Epiq Scripts, and as Chief Executive
Officer of Ronin Equity Partners, Inc., a private investment company, and in various positions with other entities and groups. Mr. Cohen
currently spends approximately 95% of his time on Company matters. As a result, Mr. Cohen dedicates only a portion of his professional
efforts to our business and operations, and there is no contractual obligation for him to spend a specific amount of his time with us.
Mr. Cohen may not be able to dedicate adequate time to our business and operations and we could experience an adverse effect on our operations
due to the demands placed on him from his other professional obligations. Such involvement in other businesses may therefore present
a conflict of interest regarding decisions he makes for us or with respect to the amount of time available for us. If we lose his services
or if he fails to perform in his current position, or if we are not able to attract and retain skilled personnel as needed, our business
could suffer. Significant turnover in our senior management could significantly deplete our institutional knowledge held by our existing
senior management team. We depend on the skills and abilities of these key personnel in managing our operations, product development,
marketing and sales aspects of our business, any part of which could be harmed by turnover in the future.
Moving
forward, should the services of Mr. Cohen be lost for any reason, we will incur costs associated with recruiting replacements and any
potential delays in operations which this may cause. If we are unable to replace such individual with a suitably trained alternative
individual(s), we may be forced to scale back or curtail our business plan.
Separately,
if our executive officers do not devote sufficient time towards our business, we may never be able to effectuate our business plan.
We
have engaged, and in the future may engage, in transactions with related parties and such transactions present possible conflicts of
interest that could have an adverse effect on us.
We
have entered, and may continue to enter, into transactions with related parties for financing, corporate, business development and operational
services. Included in such transactions is a Master Services Agreement and Statement of Work and Consulting Agreement with Epiq Scripts,
LLC, a related party, 52% owned and controlled by Jacob D. Cohen, our Chairman and Chief Executive Officer, as discussed in greater detail
under “ Item 1. Business—Material Agreements ”, for pharmacy and compounding services, which has been assigned
to Mango & Peaches. Such transactions may not have been/may not be, entered into on an arm’s-length basis, and we may have
achieved more or less favorable terms because such transactions were entered into with our related parties. This could have a material
effect on our business, results of operations and financial condition. Such conflicts could cause an individual in our management to
seek to advance his or her economic interests or the economic interests of certain related parties above ours. Further, the appearance
of conflicts of interest created by related party transactions could impair the confidence of our investors.
We
are significantly reliant on related party relationships.
We
have entered into a Master Services Agreement and Statement of Work and Consulting Agreement with Epiq Scripts, LLC, a related party,
52% owned and controlled by Jacob D. Cohen, our Chairman and Chief Executive Officer, who also serves as a co-Manager of Epiq Scripts,
as discussed in greater detail under “ Item 1. Business—Material Agreements ”, for pharmacy and compounding services,
which has been assigned to Mango & Peaches. In the event that relationship is terminated, our costs may increase, and we may be unable
to effectively obtain the services currently provided by Epiq Scripts, LLC. Additionally, certain of our consultants are employed by
Epiq Scripts, LLC. We also anticipate entering into other related party relationships in the future. While we believe that all related
party agreements have been and will be on arms-length terms, such significant related party relationships may be perceived negatively
by potential shareholders or investors and/or may result in conflicts of interest. Each of our officers and directors (including those
discussed above) presently has, and any of them in the future may have, additional fiduciary or contractual obligations to other entities
pursuant to which such officer or director may be required to present a business opportunity to such entity, subject to his or her fiduciary
duties under applicable law. Additionally, such persons may have conflicts of interest in allocating their time among various business
activities. These conflicts may not be resolved in our favor. Our significant related party relationships and transactions, the terms
of such relationships and transactions, and/or the termination of any such relationships or transactions, may have a material adverse
effect on our results of operations moving forward and/or create conflicts of interest or perceived conflicts of interest which may have
a material adverse effect on the value of our securities.
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The
related party pharmacy we have entered into an agreement with may not receive licenses in all of the 50 United States to provide national
coverage for us to sell our Pharmaceutical Products and future products.
We
have entered into a Master Services Agreement and Statement of Work and Consulting Agreement with Epiq Scripts, LLC, a related party,
52% owned and controlled by Jacob D. Cohen, our Chairman and Chief Executive Officer, as discussed in greater detail under “ Item
1. Business—Material Agreements—Master Services Agreement, ” for pharmacy and compounding services, which has been
assigned to Mango & Peaches. Epiq Script’s ability to provide pharmacy services in each state is subject to, among other things,
receipt of regulatory approvals and licenses in the states in which it operates. Currently Epiq Scripts holds State Board of Pharmacy
(or its equivalent) licenses to operate in the District of Columbia and 49 states: Alaska, Arizona, Arkansas, California, Colorado, Connecticut,
Delaware, Florida, Georgia, Hawaii, Idaho, Illinois, Indiana, Iowa, Kansas, Kentucky, Louisiana, Maine, Maryland, Massachusetts, Michigan,
Minnesota, Mississippi, Missouri, Montana, Nebraska, Nevada, New Hampshire, New Jersey, New Mexico, New York, North Carolina, North Dakota,
Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Vermont, Virginia, Washington,
West Virginia, Wisconsin, and Wyoming. Its failure to receive regulatory approval or licenses in the other states in which we hope to
operate, or loss of such licenses in the future, may prohibit us from selling our Mango products to customers that reside in those states
limiting our ability to grow and compete with other companies that have those capabilities. Any of the above may have an adverse effect
on our revenues, operations and cash flow and cause the value of our securities to decline in value or become worthless. We also face
related party conflicts associated with our engagement of Epiq Scripts, LLC as discussed in greater detail above.
Assuming
the shareholder approval of the issuance of the Mango & Peaches Common Shares and Mango & Peaches Series A Shares, Jacob D. Cohen,
our Chairman and Chief Executive Officer will exercise majority voting control over Mango & Peaches, which following the transactions
related to the Contribution Agreement, holds substantially all of our assets and operations, which limits shareholders’ abilities
to influence corporate matters and could delay or prevent a change in corporate control.
Pursuant
to the December 13, 2024, Contribution Agreement, the Company contributed substantially all of its assets, including ownership of: (a)
its 98% ownership of MangoRx Mexico S.A. de C.V., a Mexican Stock Company; and (b) its 100% ownership of MangoRx UK Limited, a company
incorporated under the laws of the United Kingdom, to Mango & Peaches, in order to restructure the ownership and operations of the
Company, better segregate such operations and liabilities and provided for the issuance of a portion of the capital of Mango & Peaches
to Mr. Jacob Cohen, the Chief Executive Officer of the Company, as additional consideration to Mr. Cohen, as discussed in greater detail
below under “ Item 11. Executive Compensation ”—“ Employment and Consulting Agreements ”—
“ Jacob D. Cohen, Chief Executive Officer ”, pursuant to which the Company agreed to issue Mr. Cohen (a) 1,700,000 shares
of the common stock of Mango & Peaches (representing 25.4% of Mango and Peaches’ then outstanding shares of common stock);
and (b) 100 shares Series A Super Majority Voting Preferred Stock of Mango & Peaches, discussed in greater detail below, which issuances
are subject to shareholder approval, which shareholder approval the Company expects to solicit from shareholders in the near future.
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In
consideration for the transfer of the assets, the Company received 4,999,999 shares of Mango & Peaches’ common stock, bringing
its ownership to 5,000,000 shares of common stock of Mango & Peaches upon the closing of the Contribution Agreement.
Pursuant
to the Contribution Agreement, Mango & Peaches assumed all of the liabilities of the Company relating to the Contributed Assets contributed,
but none of the other liabilities of the Company and the Company agreed to indemnify Mango & Peaches against any damages relating
to a breach of any representation or warranty of the Company in the Contribution Agreement, or any claim relating to the Contributed
Assets, before the Contribution Effective Date; and Mango & Peaches agreed to indemnify the Company against any damages relating
to a breach of any representation or warranty of Mango & Peaches in the Contribution Agreement, or any claim relating to the Contributed
Assets, after the Contribution Effective Date. The Contribution Agreement and the contribution and assumption provided for therein was
effective December 15, 2024.
The
Mango & Peaches Series A Shares have the right to vote on all shareholder matters (including, but not limited to at every meeting
of the stockholders of Mango & Peaches and upon any action taken by stockholders of Mango & Peaches with or without a meeting)
equal to fifty-one percent (51%) of the total vote, and for so long as Series A Preferred Stock is outstanding, Mango & Peaches shall
not, without the affirmative vote of the holders of at least 66-2/3% of all outstanding shares of Series A Preferred Stock, voting separately
as a class (i) amend, alter or repeal any provision of the Certificate of Formation or the Bylaws of Mango & Peaches so as to adversely
affect the designations, preferences, limitations and relative rights of the Series A Preferred Stock, (ii) effect any reclassification
of the Series A Preferred Stock, (iii) designate any additional series of preferred stock, the designation of which adversely effects
the rights, privileges, preferences or limitations of the Series A Preferred Stock; or (iv) amend, alter or repeal any provision of the
Series A Designation (except in connection with certain non-material technical amendments). Additionally, subject to the rights of series
of preferred stock which may from time to time come into existence, so long as any shares of Series A Preferred Stock are outstanding,
Mango & Peaches cannot without first obtaining the approval (by written consent, as provided by law) of the holders of a majority
of the then outstanding shares of Series A Preferred Stock, voting together as a class: (a) issue any additional shares of Series A Preferred
Stock after the original issuance of shares of Series A Preferred Stock; (b) increase or decrease the total number of authorized or designated
shares of Series A Preferred Stock; (c) effect an exchange, reclassification, or cancellation of all or a part of the Series A Preferred
Stock; (d) effect an exchange, or create a right of exchange, of all or part of the shares of another class of shares into shares of
Series A Preferred Stock; or (e) alter or change the rights, preferences or privileges of the shares of Series A Preferred Stock so as
to affect adversely the shares of such series, including the rights set forth in the Series A Designation.
As
a result of the issuance of the Mango & Peaches Common Shares and Mango & Peaches Series A Shares, Mr. Cohen will obtain majority
control over substantially all of the assets and operations of the Company at the time of the entry into the Contribution Agreement,
which following the Contribution Effective Date, are held by Mango & Peaches, including the right to vote 75.5% of Mango & Peaches
outstanding voting shares as result of his ownership of Mango & Peaches Common Shares and the Mango & Peaches Series A Shares,
which will provide him the right to approve any merger or consolidation of Mango & Peaches and/or any amendment to the Certificate
of Formation of Mango & Peaches.
Additionally,
Mr. Cohen, pursuant to the terms of his Employment Agreement, as amended, discussed in greater detail below under “ Item 11.
Executive Compensation ”—“ Employment and Consulting Agreements ”— “ Jacob D. Cohen, Chief
Executive Officer ”, has the right to earn up to $10 million bonus (the “ Mango & Peaches Bonus ”), which
is convertible at his option, at a conversion price of $0.50 per share, into up to 20,000,000 shares of common stock of Mango & Peaches.
In the event the full amount of the Mango & Peaches Bonus, vests to Mr. Cohen and he converts such entire Mango & Peaches Bonus
into 20,000,000 Mango & Peaches Bonus Shares pursuant to the conversion terms thereof, he will own 81.3% of Mango & Peaches outstanding
common stock (not factoring in any other issuances), and 92.8% of Mango & Peaches’ outstanding voting stock (as a result of
the ownership of the Mango & Peaches Series A Shares and not factoring in any future issuances). There is no assurance that any of
the milestones will be reached by Mango & Peaches and/or that any portion of the Mango & Peaches Bonus will vest to Mr. Cohen
or that any Mango & Peaches Bonus Shares will be issued to Mr. Cohen.
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As
a result, Mr. Cohen will control the Mango & Peaches shareholder vote. Consequently, he has the ability to influence matters affecting
Mango & Peaches and therefore exercise significant control in determining the outcome of all corporate transactions or other matters
involving Mango & Peaches, including (i) making amendments to Mango & Peaches’ certificate of formation; (ii) whether to
issue additional shares of common stock and preferred stock of Mango & Peaches, including to himself; (iii) employment decisions,
including compensation arrangements; (iv) whether to enter into material transactions with related parties; (v) election of directors;
and (vi) any merger or significant corporate transactions, including with himself or other related parties. Additionally, it will be
difficult if not impossible for investors to remove Mr. Cohen as a director of Mango & Peaches, which will mean he will remain in
control of who serves as officers of the Company as well as whether any changes are made in the Board of Directors. Because Mr. Cohen
will significantly influence the vote on all Mango & Peaches shareholder matters, investors may find it difficult to replace our
management if they disagree with the way our business is being operated. The interests of Mr. Cohen may not coincide with our interests
or the interests of other shareholders of the Company or Mango & Peaches.
In
addition, this concentration of ownership might adversely affect the market price of our common stock by: (1) delaying, deferring or
preventing a change of control of our Company or Mango & Peaches; (2) impeding a merger, consolidation, takeover or other business
combination involving our Company or Mango & Peaches; or (3) discouraging a potential acquirer from making a tender offer or otherwise
attempting to obtain control of our Company or Mango & Peaches.
Potential
competition from our existing executive officers, after they leave their employment with us, and subject to the non-compete terms of
their employment agreements, could negatively impact our profitability.
Although
our Chief Executive Officer, Jacob D. Cohen and our Chief Operating Officer, Amanda Hammer, are prohibited from competing with us while
they are employed with us and for 12 months thereafter (subject to the terms of, and exceptions set forth in, their employment agreements
with the Company), none of such individuals will be prohibited from competing with us after such 12-month period ends. Additionally,
the Federal Trade Commission has previously proposed a rule that, if it becomes effective, would ban employers from imposing non-competes
on their workers, which if effective could prohibit the Company from enforcing, or invalidate, the non-competes in our executive’s
and in certain other employee’s, employment agreements. Finally, various states have recently enacted rules banning non-competes,
including California. Accordingly, any of these individuals could be in a position to use industry experience gained while working with
us to compete with us. Such competition could distract or confuse customers, reduce the value of our intellectual property and trade
secrets, or reduce our future revenues, earnings or growth prospects.
Risks
Related to Intellectual Property
We
operate in an industry with the risk of intellectual property litigation. Claims of infringement against us may hurt our business.
We
must protect the proprietary nature of the intellectual property used in our business. There can be no assurance that trade secrets and
other intellectual property will not be challenged, invalidated, misappropriated or circumvented by third parties.
Additionally,
our success depends, in part, upon non-infringement of intellectual property rights owned by others and being able to resolve claims
of intellectual property infringement without major financial expenditures or adverse consequences. Participants that own, or claim to
own, intellectual property may aggressively assert their rights. From time to time, we may be subject to legal proceedings and claims
relating to the intellectual property rights of others. Future litigation may be necessary to defend us by determining the scope, enforceability,
and validity of third-party proprietary rights or to establish its proprietary rights. Our competitors have substantially greater resources
and are able to sustain the costs of complex intellectual property litigation to a greater degree and for longer periods of time. In
addition, patent holding companies that focus solely on extracting royalties and settlements by enforcing patent rights may target us.
Regardless of whether claims that we are infringing patents or other intellectual property rights have any merit, these claims are time-consuming
and costly to evaluate and defend and could:
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●
cause
delays or stoppages in providing products;
●
divert
management’s attention and resources;
●
require
technology changes to our products that would cause our Company to incur substantial cost;
●
subject
us to significant liabilities; and
●
require
us to cease some or all of our activities.
In
addition to liability for monetary damages, which may be tripled and may include attorneys’ fees, or, in some circumstances, damages
against clients, we may be prohibited from developing, commercializing, or continuing to provide some or all of our products unless we
obtain licenses from, and pay royalties to, the holders of the patents or other intellectual property rights, which may not be available
on commercially favorable terms, or at all.
Risks
Related to the Telehealth Operations of Our Contracting Parties
The
telehealth business of our telehealth provider could be adversely affected by ongoing legal challenges or by new state actions restricting
the ability to provide telehealth services in certain states.
We
use telehealth providers to provide telehealth consultations and related services on our Mangoceuticals platform, which connects users/customers
with third-party health care providers and Epiq Scripts, LLC, a related party pharmacy. We have entered into agreements with our Telemedicine
Providers, pursuant to which our Telemedicine Providers provide clinical services directly to our customers via telehealth. Through these
arrangements, the professionals or professional entities are responsible for the practice of medicine and control of the clinical decision-making.
Our
ability to conduct business operations in each state is dependent upon the state’s treatment of medicine under such state’s
laws, and rules and policies governing the practice of physician supervised services, which are subject to changing political, regulatory
and other influences.
We
depend on our contracted parties to maintain appropriate telehealth licenses to be able to provide telehealth services to our potential
customers and prescribe them our products, which are required to be prescribed by licensed physicians. In the event we are not able to
maintain relationships with telehealth providers, state licensing laws make it harder, more costly or impossible to provide telehealth
services, or our customers are otherwise unable to obtain prescriptions for our products, we may be unable to sell products, which could
result in us having to curtail our business plan or cease operating.
Our
contracting parties’ telehealth business could be adversely affected by ongoing legal challenges to their business model or by
new state actions restricting their ability to provide the full range of services in certain states.
The
ability of our contracted parties’ telehealth operations in each state is dependent upon the state’s treatment of medicine
under such state’s laws, rules and policies governing the practice of physician supervised services, which are subject to changing
political, regulatory and other influences. In the event our contracted parties are unable to provide telehealth services for any reason,
it would have a material adverse effect on our ability to sell products and in turn our revenues and operating results.
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Risks
Related to Our Governing Documents and Texas Law
Our
Certificate of Formation, Bylaws and Texas law provide for indemnification of officers and directors at our expense and limit the liability
of our directors, which may result in a major cost to us and hurt the interests of our shareholders because corporate resources may be
expended for the benefit of officers or directors.
Our
Certificate of Formation, Bylaws and Texas law provide for us to indemnify and hold harmless, to the fullest extent permitted by applicable
law, each person who is or was made a party or is threatened to be made a party to or is otherwise involved in any threatened, pending
or completed action, suit or proceeding by reason of the fact that he or she is or was a director or officer of the Company or, while
a director or officer of the Company, is or was serving at the request of the Company as a director, officer, employee or agent of another
corporation or of a partnership, joint venture, trust, other enterprise or nonprofit entity, including service with respect to an employee
benefit plan. Our Certificate of Formation also provides that the personal liability of our directors is eliminated to the fullest extent
permitted by the Texas Business Organizations Code, as such may be amended or supplemented. These indemnification obligations and limitations
of liability may result in a major cost to us and hurt the interests of our shareholders because corporate resources may be expended
for the benefit of officers or directors.
We
have been advised that, in the opinion of the SEC, indemnification for liabilities arising under federal securities laws is against public
policy as expressed in the Securities Act and is, therefore, unenforceable. In the event that a claim for indemnification for liabilities
arising under federal securities laws, other than the payment by us of expenses incurred or paid by a director, officer or controlling
person in the successful defense of any action, suit or proceeding, is asserted by a director, officer or controlling person in connection
with our activities, we will (unless in the opinion of our counsel, the matter has been settled by controlling precedent) submit to a
court of appropriate jurisdiction, the question whether indemnification by us is against public policy as expressed in the Securities
Act and will be governed by the final adjudication of such issue. The legal process relating to this matter if it were to occur is likely
to be very costly and may result in us receiving negative publicity, either of which factors is likely to materially reduce the market
and price for our shares.
We
have established preferred stock which can be designated by our Board of Directors without shareholder approval.
We
have 10,000,000 shares of preferred stock authorized, of which 6,000 shares have been designated as Series B Convertible Preferred Stock,
discussed in greater detail under “ Item 7. Management’s Discussion and Analysis of Financial Condition and Results of
Operations—Liquidity and Capital Resources—Funding Arrangements ” and 6,250,000 shares have been designated as Series
C Preferred Stock, discussed in greater detail under “ Item 1. Business—Material Agreements—Patent Purchase Agreements—Intramont
Technologies ”, which are also discussed in greater detail below under “ Risks Related to our Preferred Stock ”.
Additional shares of our preferred stock may be issued from time to time in one or more series, each of which shall have a distinctive
designation or title as shall be determined by our Board of Directors prior to the issuance of any shares thereof. The preferred stock
shall have such voting powers, full or limited, or no voting powers, and such preferences and relative, participating, optional or other
special rights and such qualifications, limitations or restrictions thereof as adopted by the Board of Directors. Because the Board of
Directors is able to designate the powers and preferences of the preferred stock without the vote of a majority of our shareholders,
our shareholders will have no control over what designations and preferences our preferred stock will have. The currently outstanding
preferred stock or issuance of additional shares of preferred stock or the rights associated therewith, could cause substantial dilution
to our existing shareholders. Additionally, the dilutive effect of any preferred stock which we have or may issue may be exacerbated
given the fact that such preferred stock may have voting rights and/or other rights or preferences which could provide the preferred
shareholders with substantial voting control over us and/or give those holders the power to prevent or cause a change in control, even
if that change in control might benefit our shareholders. As a result, the issuance of shares of preferred stock may cause the value
of our securities to decrease.
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Anti-takeover
provisions in our Certificate of Formation and our Bylaws, as well as provisions of Texas law, might discourage, delay or prevent a change
in control of our company or changes in our management and, therefore, depress the trading price of our common stock.
Our
Certificate of Formation, Bylaws and Texas law contain provisions that may discourage, delay or prevent a merger, acquisition or other
change in control that shareholders may consider favorable, including transactions in which you might otherwise receive a premium for
your shares of our common stock. These provisions may also prevent or delay attempts by our shareholders to replace or remove our management.
Our corporate governance documents include provisions:
●
requiring
advance notice of shareholder proposals for business to be conducted at meetings of our shareholders and for nominations of candidates
for election to our Board of Directors;
●
authorizing
blank check preferred stock, which could be issued with voting, liquidation, dividend and other rights superior to our common stock;
and
●
providing
indemnification to, our directors and officers.
The
existence of the foregoing provisions and anti-takeover measures could limit the price that investors might be willing to pay in the
future for shares of our common stock. They could also deter potential acquirers of our company, thereby reducing the likelihood that
you could receive a premium for your common stock in an acquisition.
Risks
Related to Our Preferred Stock
Our
Series B Convertible Preferred Stock and 6% Series C Convertible Cumulative Preferred Stock include a liquidation preference.
Our
Series B Preferred Stock includes a liquidation preference of $1,100 per share, which may be increased from time to time pursuant to
the terms of such Series B Preferred Stock (currently totaling an aggregate of $2,809,400 for all 2,554 outstanding shares of Series
B Preferred Stock) which is payable upon liquidation, before any distribution to our common stock shareholders. Our Series C Preferred
Stock includes a liquidation preference of $20 per share, which may be increased from time to time pursuant to the terms of such Series
C Preferred Stock (currently totaling an aggregate of $19,600,000 for all outstanding shares of Series C Preferred Stock) which is payable
upon liquidation, before any distribution to our common stock shareholders, but after distributions to our Series B Preferred Stock holders.
As a result, if we were to dissolve, liquidate or sell our assets, the holders of our Series B Preferred Stock would have the right to
receive up to the first approximately $2,809,400 in proceeds from any such transaction and holders of our Series C Preferred Stock would
have the right to receive up to approximately $19.6 million of the remaining proceeds from any such transaction. The payment of the liquidation
preferences could result in common stock shareholders not receiving any consideration if we were to liquidate, dissolve or wind up, either
voluntarily or involuntarily. Additionally, the existence of the liquidation preferences may reduce the value of our common stock, make
it harder for us to sell shares of common stock in offerings in the future, or prevent or delay a change of control. Because our Board
of Directors is entitled to designate the powers and preferences of the preferred stock without a vote of our shareholders, subject to
Nasdaq rules and regulations, our shareholders will have no control over what designations and preferences our future preferred stock,
if any, will have.
The
issuance of common stock upon conversion of the Series B Preferred Stock and Series C Preferred Stock and upon exercise of the Warrants
will cause immediate and substantial dilution to existing shareholders.
Each
holder of Series B Preferred Stock may, at its option, convert its shares of Series B Preferred Stock into that number of shares of common
stock equal to the Stated Value of such share of Series B Preferred Stock (initially $1,100 per share), divided by $1.50.
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Each
holder of Series C Preferred Stock may, at its option, convert its shares of Series C Preferred Stock into that number of shares of common
stock equal to the Stated Value of such share of Series C Preferred Stock, divided by the conversion price of $150.00 per share (i.e.,
initially a 2-for-1 conversion ratio), subject to adjustment for stock splits and stock dividends, with any fractional shares rounded
up to the nearest whole share.
The
issuance of common stock upon conversion of the Series B Preferred Stock and Series C Preferred Stock will result in immediate and substantial
dilution to the interests of other stockholders since the holders of the Series B Preferred Stock and Series C Preferred Stock may ultimately
receive and sell the full amount of shares issuable in connection with the conversion of such Series B Preferred Stock and Series C Preferred
Stock. Although the Series B Preferred Stock, and Series C Preferred Stock may not be converted by the holders thereof if such conversion
would cause such holder to own more than 4.99% (4.999% in the case of the Series C Preferred Stock) of our outstanding common stock (which
may be increased to 9.999% with at least 61 days prior written notice on a per shareholder basis for holders of our Series C Preferred
Stock), these restrictions do not prevent such holders from converting some of their holdings, selling those shares, and then converting
the rest of their holdings, while still staying below the 4.99%/9.999% limit. In this way, the holders of the Series B Preferred Stock
and Series C Preferred Stock could sell more than these limits while never actually holding more shares than the limits allow. If the
holders of the Series B Preferred Stock or Series C Preferred Stock choose to do this, it will cause substantial dilution to the then
holders of our common stock.
The
availability of shares of common stock upon conversion of the Series B Preferred Stock and Series C Preferred Stock for public resale,
as well as any actual resales of these shares, could adversely affect the trading price of our common stock. We cannot predict the size
of future issuances of our common stock upon the conversion of our Series B Preferred Stock and Series C Preferred Stock and/or upon
exercise of warrants, or the effect, if any, that future issuances and sales of shares of our common stock may have on the market price
of our common stock. Sales or distributions of substantial amounts of our common stock upon the conversion of our Series B Preferred
Stock and Series C Preferred Stock and upon exercise of warrants, or the perception that such sales could occur, may cause the market
price of our common stock to decline.
In
addition, the common stock issuable upon the conversion of our Series B Preferred Stock and Series C Preferred Stock and upon exercise
of warrants may represent overhang that may also adversely affect the market price of our common stock. Overhang occurs when there is
a greater supply of a company’s stock in the market than there is demand for that stock. When this happens the price of our stock
will decrease, and any additional shares which stockholders attempt to sell in the market will only further decrease the share price.
If the share volume of our common stock cannot absorb shares sold by holders of the Series B Preferred Stock and Series C Preferred Stock
and warrants, then the value of our common stock will likely decrease.
We
have filed a registration statement to permit the public resale of certain of the shares of common stock that may be issued upon the
conversion of the Series B Preferred Stock and Series C Preferred Stock and the exercise of certain of our warrants. The influx of those
shares into the public market could potentially have a negative effect on the trading price of our common stock.
Our
outstanding Series B Preferred Stock previously accrued, and our Series C Preferred Stock accrues a dividend.
From
and after the issuance date of the Series B Preferred Stock, of which 2,554 shares are currently outstanding, each share of Series B
Preferred Stock was entitled to receive, when, as and if authorized and declared by the Board of Directors of the Company, out of any
funds legally available therefor, cumulative dividends in an amount equal to (i) the 10% per annum on the stated value (initially $1,100
per share or $110 per year) as of the record date for such dividend (as described in the Series B Designation), and (ii) on an as-converted
basis, any dividend or other distribution, whether paid in cash, in-kind or in other property, authorized and declared by the Board of
Directors on the issued and outstanding shares of common stock in an amount determined by assuming that the number of shares of common
stock into which such shares of Series B Preferred Stock could be converted on the applicable record date for such dividend or distribution.
Effective on March 20, 2025 , with the filing of an amendment to the Series B Designation,
the rights to dividends on the Series B Preferred Stock, unless declared on the common stock, in which case the Series B Preferred Stock
will participate on an as-converted basis, were terminated.
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From
and after the issuance date of the Series C Preferred Stock, each share of Series C Preferred Stock is entitled to receive, when, as
and if authorized and declared by the Board of Directors of the Company, out of any funds legally available therefor, cumulative dividends
in an amount equal to (i) the 6% per annum on the stated value (initially $20 per share) as of the record date for such dividend (as
described in the Series C Designation), and (ii) on an as-converted basis, any dividend or other distribution, whether paid in cash,
in-kind or in other property, authorized and declared by the Board of Directors on the issued and outstanding shares of common stock
in an amount determined by assuming that the number of shares of common stock into which such shares of Series C Preferred Stock could
be converted on the applicable record date for such dividend or distribution.
Accrued
dividends may be settled in cash, subject to applicable law, shares of common stock (valued at the closing price on the date the dividend
is due) or in-kind, by increasing the stated value by the amount of the quarterly dividend.
In
the event dividends are paid in common stock of the Company, the number of shares payable will be calculated by dividing the accrued
dividend by the closing sales price of the Company’s common stock. If the Company is prohibited from paying, or chooses not to
pay the dividend in cash or common stock, the Company may pay the dividend by increasing the Stated Value of the preferred stock.
We
may choose not to pay such dividends in cash, may not have sufficient available cash to pay the dividends as they accrue or may be prohibited
contractually, or pursuant to applicable law, from paying such dividends in cash. The payment of the dividends could reduce our available
cash on hand, have a material adverse effect on our results of operations and cause the value of our stock to decline in value. Additionally,
the issuance of shares of common stock or an increase in the Stated Value of our Series C Preferred Stock
in lieu of cash dividends (and the subsequent conversion of such Series C Preferred Stock into common stock
pursuant to the terms of such Series C Preferred Stock) could cause substantial dilution to the then holders
of our common stock.
Risks
Related to Our Common Stock
Stockholders
may be diluted significantly through our efforts to obtain financing and satisfy obligations through the issuance of additional shares
of our common stock.
Wherever
possible, our Board of Directors will attempt to use non-cash consideration to satisfy obligations. In many instances, we believe that
the non-cash consideration will consist of restricted shares of our common stock or where shares are to be issued to our officers, directors
and applicable consultants. Our Board of Directors has authority, without action or vote of the stockholders, but subject to Nasdaq rules
and regulations (which generally require stockholder approval for any transactions which would result in the issuance of more than 20%
of our then outstanding shares of common stock or voting rights representing over 20% of our then outstanding shares of stock), to issue
all or part of the authorized but unissued shares of common stock. In addition, we may attempt to raise capital by selling shares of
our common stock, possibly at a discount to market. These actions will result in dilution of the ownership interests of existing stockholders,
which may further dilute common stock book value, and that dilution may be material. Such issuances may also serve to enhance existing
management’s ability to maintain control of the Company because the shares may be issued to parties or entities committed to supporting
existing management.
Our
common stock prices have been, and may continue to be, volatile and could decline substantially following the date of this Report.
The
market price of our common stock may be highly volatile and subject to wide fluctuations. Our financial performance, government regulatory
action, tax laws, interest rates, and market conditions in general could have a significant impact on the future market price of our
common stock.
Some
of the factors that could negatively affect or result in fluctuations in the market price of our common stock include:
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●
actual
or anticipated variations in our quarterly operating results;
●
changes
in market valuations of similar companies;
●
adverse
market reaction to the level of our indebtedness;
●
additions
or departures of key personnel;
●
actions
by shareholders;
●
speculation
in the press or investment community;
●
general
market, economic, and political conditions, including an economic slowdown or dislocation in the global credit markets;
●
announcements
by us or our competitors of significant acquisitions, strategic partnerships, joint ventures, collaborations, or capital commitments;
●
general
economic and market conditions;
●
disputes
or other developments related to our intellectual property or other proprietary rights, including litigation;
●
our
operating performance and the performance of other similar companies;
●
changes
in accounting principles; and
●
passage
of legislation or other regulatory developments that adversely affect us or our industry.
If
our stock price fluctuates you could lose a significant part of your investment.
The
market price of our common stock could be subject to wide fluctuations in response to, among other things, the risk factors described
in this Report, and other factors beyond our control, such as fluctuations in the valuation of companies perceived by investors to be
comparable to us For example, since our common stock began trading on the Nasdaq Capital Market in connection with our IPO on March 20,
2023, the trading price of our common stock has traded as high as $65.55 and as low as $2.07 per share. Furthermore, the stock markets
have experienced price and volume fluctuations that have affected and continue to affect the market prices of equity securities of many
companies. These fluctuations often have been unrelated or disproportionate to the operating performance of those companies. These broad
market and industry fluctuations, as well as general economic, political, and market conditions, such as recessions, interest rate changes
or international currency fluctuations, may negatively affect the market price of our common stock. In the past, many companies that
have experienced volatility in the market price of their stock have been subject to securities class action litigation. We may be the
target of this type of litigation in the future. Securities litigation against us could result in substantial costs and divert our management’s
attention from other business concerns, which could seriously harm our business.
There
is no guarantee that our common stock will continue to trade on the Nasdaq Capital Market.
Our
common stock is currently listed on Nasdaq under the symbol “ MGRX ”. There is no guarantee that we will be able to
maintain our listing on Nasdaq for any period of time. Among the conditions required for continued listing on Nasdaq, Nasdaq requires
us to maintain at least $2.5 million in stockholders’ equity, $35 million in market value of listed securities, or $500,000 in
net income over the prior two years or two of the prior three years, to have a majority of independent directors (subject to certain
“ controlled company ” exemptions), to comply with certain audit committee requirements, and to maintain a stock price
over $1.00 per share.
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On
October 30, 2023, the Company received written notice (the “ Notification Letter ”) from the Listing Qualifications
Department of The Nasdaq Stock Market LLC (“ Nasdaq ”) notifying the Company that it is not in compliance with the minimum
bid price requirements set forth in Nasdaq Listing Rule 5550(a)(2) for continued listing on The Nasdaq Capital Market. Nasdaq Listing
Rule 5550(a)(2) requires listed securities to maintain a minimum bid price of $1.00 per share, and Listing Rule 5810(c)(3)(A) provides
that a failure to meet the minimum bid price requirement exists if the deficiency continues for a period of thirty (30) consecutive business
days. The Notification Letter did not impact the Company’s listing of its common stock on the Nasdaq Capital Market at that time.
The Notification Letter stated that the Company had 180 calendar days or until April 29, 2024, to regain compliance with Nasdaq Listing
Rule 5550(a)(2), provided that such date was subsequently extended to October 28, 2024, upon request to Nasdaq, and in accordance with
Nasdaq’s rules. To regain compliance, the bid price of the Company’s common stock must have a closing bid price of at least
$1.00 per share for a minimum of 10 consecutive business days. On October 30, 2024, we were provided notice from Nasdaq that, as a result
of the Reverse Stock Split, we had gained compliance with the minimum bid price requirement of Nasdaq.
Our
stockholders’ equity has in the past not been above Nasdaq’s $2.5 million minimum, we may not generate over $500,000 of yearly
net income moving forward, we may not maintain $35 million in market value of listed securities, we may not be able to maintain independent
directors (to the extent required), and as discussed above, we have in the past not maintained a stock price over $1.00 per share. Nasdaq’s
determination that we fail to meet the continued listing standards of Nasdaq may result in our securities being delisted from Nasdaq.
The
absence of such a listing on Nasdaq may adversely affect the acceptance of our common stock as currency or the value accorded by other
parties. Further, if we are delisted, we would also incur additional costs under state blue sky laws in connection with any sales of
our securities. These requirements could severely limit the market liquidity of our common stock and the ability of our stockholders
to sell our common stock in the secondary market. If our common stock is delisted by Nasdaq, our common stock may be eligible to trade
on an over-the-counter quotation system, such as the OTCQB Market or the Pink Open Market, where an investor may find it more difficult
to sell our securities or obtain accurate quotations as to the market value of our securities. In the event our common stock is delisted
from Nasdaq in the future, we may not be able to list our common stock on another national securities exchange or obtain quotation on
an over-the counter quotation system.
A
delisting of our common stock from the Nasdaq could adversely affect our business, financial condition and results of operations and
our ability to attract new investors, reduce the price at which our common stock trades, decrease, investors’ ability to make transactions
in our common stock, decrease the liquidity of our outstanding shares, increase the transaction costs inherent in trading such shares,
and reduce our flexibility to raise additional capital without overall negative effects for our stockholders.
If
securities or industry analysts do not publish research or reports, or publish unfavorable research or reports about our business, our
stock price and trading volume may decline.
The
trading market for our common stock relies in part on the research and reports that industry or financial analysts publish about us,
our business, our markets and our competitors. We do not control these analysts. If securities analysts do not cover our common stock,
the lack of research coverage may adversely affect the market price of our common stock. Furthermore, if one or more of the analysts
who do cover us downgrade our stock or if those analysts issue other unfavorable commentary about us or our business, our stock price
would likely decline. If one or more of these analysts cease coverage of us or fails to regularly publish reports on us, we could lose
visibility in the market and interest in our stock could decrease, which in turn could cause our stock price or trading volume to decline
and may also impair our ability to expand our business with existing customers and attract new customers.
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Certain
of our outstanding warrants include anti-dilution and reset rights.
We
currently have outstanding warrants to purchase 2,062,333 shares of common stock with a weighted average exercise price of $2.84 per
share. The exercise price of a total of 1,650,000 of those warrants, with an exercise price of $1.50 per share have anti-dilutive rights,
such that if the Company or any subsidiary at any time while the warrants are outstanding, shall sell, enter into an agreement to sell
or grant any option to purchase, or sell or grant any right to reprice, or otherwise dispose of or issue (or announce any offer, sale,
grant or any option to purchase or other disposition) any common stock or common stock equivalents, at an effective price per share less
than the exercise price of the warrants then in effect (such lower price, the “ Base Share Price ” and such issuances
collectively, a “ Dilutive Issuance ”) then simultaneously with the consummation (or, if earlier, the announcement)
of each Dilutive Issuance the exercise price shall be reduced and only reduced to equal the Base Share Price. No adjustment however is
to be made for certain customary exempt issuances.
The
warrants also include customary buy-in rights in the event the Company fails to timely deliver the shares of common stock issuable upon
exercise thereof.
Anti-dilutive
rights of the warrants may cause the exercise price of the warrants to decrease significantly, may result to significant dilution to
existing stockholders, and may prevent us from completing otherwise accretive transactions.
The
sale of shares of common stock under an Equity Purchase Agreement may cause significant dilution to existing shareholders.
The
issuance of shares of common stock pursuant to the terms of an April 5, 2024, Equity Purchase Agreement (the
“ ELOC ”), discussed in greater below under “ Item 7. Management’s Discussion and Analysis of
Financial Condition and Results of Operations—Liquidity and Capital Resources—Funding Arrangements ”, will have
a dilutive effect on the Company’s existing stockholders, including, over time, the voting power of the existing stockholders.
The issuance of shares of common stock pursuant to the terms of the ELOC (pursuant to which we are able to sell up to $25 million
shares of common stock, subject to certain requirements, of which $1,185,019 of gross proceeds or 305,000 total shares of common
stock have been sold to date) will also dilute the ownership interests of our existing stockholders. The availability of these
shares for public resale, as well as any actual resales of these shares, could adversely affect the trading price of our common
stock. We cannot predict the size of future issuances of our common stock pursuant to the terms of the ELOC, or the effect, if any,
that future issuances and sales of shares of our common stock may have on the market price of our common stock. Sales or
distributions of substantial amounts of our common stock pursuant to the terms of the ELOC, or the perception that such sales could
occur, may cause the market price of our common stock to decline.
In
addition, the common stock issuable pursuant to the terms of the ELOC may represent overhang that may also adversely affect the market
price of our common stock. Overhang occurs when there is a greater supply of a company’s stock in the market than there is demand
for that stock. When this happens the price of our stock will decrease, and any additional shares which stockholders attempt to sell
in the market will only further decrease the share price. If the share volume of our common stock cannot absorb shares sold by the Purchaser,
then the value of our common stock will likely decrease.
We
have filed a registration statement to permit the public resale of the shares of common stock issuable pursuant to the terms of the ELOC.
The influx of those shares into the public market could potentially have a negative effect on the trading price of our common stock.
The
shares of common stock to be sold pursuant to the terms of the ELOC are to be sold based on a discount to fluctuating market prices and
as a result, we are unable to accurately forecast or predict with certainty the total amount of shares of Company common stock that may
be issued to the Purchaser under the ELOC; however, we expect such sales, if any to cause significant dilution to existing shareholders.
Future
sales of our common stock, other securities convertible into our common stock, or preferred stock could cause the market value of our
common stock to decline and could result in dilution of your shares.
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Our
Board of Directors is authorized, without your approval, to cause us to issue additional shares of our common stock or to raise capital
through the creation and issuance of additional preferred stock, other debt securities convertible into common stock, options, warrants
and other rights, on terms and for consideration as our Board of Directors in its sole discretion may determine. Sales of substantial
amounts of our common stock or of preferred stock could cause the market price of our common stock to decrease significantly. We cannot
predict the effect, if any, of future sales of our common stock, or the availability of our common stock for future sales, on the value
of our common stock. Sales of substantial amounts of our common stock by large shareholders, or the perception that such sales could
occur, may adversely affect the market price of our common stock.
We
have no intention of declaring dividends on our common stock in the foreseeable future.
The
decision to pay cash dividends on our common stock rests with our Board of Directors and will depend on our earnings, unencumbered cash,
capital requirements and financial condition. We do not anticipate declaring any dividends on our common stock in the foreseeable future,
as we intend to use any excess cash to fund our operations. Investors in our common stock should not expect to receive dividend income
on their investment, and investors will be dependent on the appreciation of our common stock to earn a return on their investment.
The
issuance and sale of common stock upon exercise of outstanding warrants may cause substantial dilution to existing shareholders and may
also depress the market price of our common stock. Outstanding warrants to purchase shares of our common stock have cashless exercise
rights.
As
of the date of this Report, we had a total of 2,062,333 warrants outstanding with a weighted average exercise price of $2.84 per share
and term ranging from August 16, 2027 through February 13, 2030. If the holders of the warrants choose to exercise the warrants, it may
cause significant dilution to the then holders of our common stock. If exercises of the warrants and sales of such shares issuable upon
exercise thereof take place, the price of our common stock may decline. In addition, the common stock issuable upon exercise of the warrants
may represent overhang that may also adversely affect the market price of our common stock. Overhang occurs when there is a greater supply
of a company’s stock in the market than there is demand for that stock. When this happens the price of our stock will decrease,
and any additional shares which shareholders attempt to sell in the market will only further decrease the share price. If the share volume
of our common stock cannot absorb shares sold by the warrant holders, then the value of our common stock will likely decrease.
General
Risk Factors
Our
industry and the broader U.S. economy experienced higher than expected inflationary pressures during 2022 related to continued supply
chain disruptions, labor shortages and geopolitical instability, and if these conditions persist, our business, results of operations
and cash flows could be materially and adversely affected.
2022
saw significant increases in the costs of labor and certain materials and equipment, and longer lead times for such materials and equipment,
as a result of availability constraints, supply chain disruption, increased demand, labor shortages associated with a fully employed
U.S. labor force, high inflation and other factors. Supply and demand fundamentals have been further aggravated by disruptions in global
energy supply caused by multiple geopolitical events, including the ongoing conflict between Russia and Ukraine. It is also currently
unknown how the supply chain will react to tariffs threated and actually imposed by President Trump, and counties reactions thereto.
Supply chain constraints and inflationary pressures have in the past, and may in the future, adversely impact our operating costs, and
as a result, our business, financial condition, results of operations and cash flows could be materially and adversely affected.
We
and the health and wellness industry in general may be adversely affected during periods of high inflation, primarily because of higher
shipping and product manufacturing costs. While we plan to attempt to pass on increases in our costs through increased sales prices,
market forces may limit our ability to do so. If we are unable to raise sales prices enough to compensate for higher costs, our future
revenues, gross profit margin and revenues could be adversely affected.
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Economic
uncertainty may affect our access to capital and/or increase the costs of such capital.
Global
economic conditions continue to be volatile and uncertain due to, among other things, consumer confidence in future economic conditions,
fears of recession and trade wars, the price of energy, fluctuating interest rates, the availability and cost of consumer credit, the
availability and timing of government stimulus programs, levels of unemployment, changes in inflation and key rates, tax rates, and the
war between Ukraine and Russia which began in February 2022, and has continued through the date of this Report, as well as the current
ongoing war between Hamas and Israel, which began in October 2023, and has continued through the date of this Report. These conditions
remain unpredictable and create uncertainties about our ability to raise capital in the future. In the event required capital becomes
unavailable in the future, or more costly, it could have a material adverse effect on our business, future results of operations, and
financial condition.
Our
business may be materially and adversely disrupted by epidemics or pandemics in the future.
An
epidemic, pandemic or similar serious public health issue, and the measures undertaken by governmental authorities to address it, could
significantly disrupt or prevent us from operating our business in the ordinary course for an extended period, and thereby, and/or along
with any associated economic and/or social instability or distress, have a material adverse impact on our financial statements.
Our
business could be disrupted by catastrophic events and man-made problems, such as power disruptions, data security breaches, and terrorism.
Our
systems are vulnerable to damage or interruption from the occurrence of any catastrophic event, including earthquake, fire, flood, or
other weather event, power loss, telecommunications failure, software or hardware malfunction, cyber-attack, war, terrorist attack, or
incident of mass violence, which could result in lengthy interruptions in access to our systems. In addition, acts of terrorism, including
malicious internet-based activity, could cause disruptions to the internet or the economy as a whole. If our systems were to fail or
be negatively impacted as a result of a natural disaster or other event, our ability to provide products to customers would be impaired
or we could lose critical data. We do not carry business interruption insurance sufficient to compensate us for the potentially significant
losses, including the potential harm to our business, financial condition and results of operations that may result from interruptions
in access to our platform as a result of system failures.
Economic
uncertainty may affect consumer purchases of discretionary items, which may affect demand for our products.
Our
products may be considered discretionary items for consumers. Factors affecting the level of consumer spending for such discretionary
items include general economic conditions and other factors such as consumer confidence in future economic conditions, fears of recession
and trade wars, the price of energy, fluctuating interest rates, the availability and cost of consumer credit, the availability and timing
of government stimulus programs, levels of unemployment, inflation, and tax rates. As U.S. economic conditions continue to be volatile
or economic uncertainty remains, and with increasing inflation and interest rates, trends in consumer discretionary spending also remain
unpredictable and subject to reductions as a result of significant increases in employment, financial market instability, and uncertainties
about the future. Unfavorable economic conditions have led, and in the future may lead, consumers to reduce their spending on men’s
wellness products, which in turn has in the past led to a decrease in the demand for such products. Consumer demand for the Company’s
products may decline as a result of an economic downturn, or economic uncertainty. The sensitivity to economic cycles and any related
fluctuation in consumer demand may have a material adverse effect on the Company’s business, results of operations, and financial
condition.
Global
economic conditions could materially adversely affect our business, results of operations, financial condition and growth.
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Adverse
macroeconomic conditions, including inflation, slower growth or recession, new or increased tariffs, changes to fiscal and monetary policy,
tighter credit, higher interest rates, high unemployment and currency fluctuations could materially adversely affect our operations,
expenses, access to capital and the market for our products. In addition, consumer confidence and spending could be adversely affected
in response to financial market volatility, negative financial news, conditions in the real estate and mortgage markets, declines in
income or asset values, changes to fuel and other energy costs, labor and healthcare costs and other economic factors.
In
addition, uncertainty about, or a decline in, global or regional economic conditions could have a significant impact on our expected
funding sources, suppliers and partners. Potential effects include financial instability; inability to obtain credit to finance operations
and purchases of our products; and insolvency.
A
downturn in the economic environment could also lead to limitations on our ability to issue new debt; reduced liquidity; and declines
in the fair value of our financial instruments. These and other economic factors could materially adversely affect our business, results
of operations, financial condition and growth.
We
may become party to litigation, mediation and/or arbitration from time to time given our product focus.
We
may become party to regulatory proceedings, litigation, mediation and/or arbitration from time to time in the ordinary course of business
which could adversely affect our business. Monitoring and defending against legal actions, whether or not meritorious, can be time-consuming,
divert management’s attention and resources and cause us to incur significant expenses. In addition, legal fees and costs incurred
in connection with such activities may be significant and we could, in the future, be subject to judgments or enter into settlements
of claims for significant monetary damages. While we expect to have insurance in the future that may cover the costs and awards of certain
types of litigation, the amount of our future insurance may not be sufficient to cover any costs or awards. Substantial litigation costs
or an adverse result in any litigation may adversely impact our business, operating results or financial condition.
Higher
labor costs due to statutory and regulatory changes could materially adversely affect our business, financial condition and operating
results.
Various
federal and state labor laws govern our relationships with our employees and affect operating costs. These laws include employee classifications
as exempt or non-exempt, minimum wage requirements, unemployment tax rates, workers’ compensation rates, overtime, family leave,
workplace health and safety standards, payroll taxes, citizenship requirements and other wage and benefit requirements for employees
classified as non-exempt. As certain of our employees are paid at rates set at, or above but related to, the applicable minimum wage,
further increases in the minimum wage could increase our labor costs. Significant additional government regulations could materially
adversely affect our business, financial condition and operating results.
Failure
to adequately manage our planned aggressive growth strategy may harm our business or increase our risk of failure.
For
the foreseeable future, we intend to pursue an aggressive growth strategy for the expansion of our operations through increased marketing.
Our ability to rapidly expand our operations will depend upon many factors, including our ability to work in a regulated environment,
establish and maintain strategic relationships with suppliers, and obtain adequate capital resources on acceptable terms. Any restrictions
on our ability to expand may have a materially adverse effect on our business, results of operations, and financial condition. Accordingly,
we may be unable to achieve our targets for sales growth, and our operations may not be successful or achieve anticipated operating results.
Additionally,
our growth may place a significant strain on our managerial, administrative, operational, and financial resources and our infrastructure.
Our future success will depend, in part, upon the ability of our senior management to manage growth effectively. This will require us
to, among other things:
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●
implement
additional management information systems;
●
further
develop our operating, administrative, legal, financial, and accounting systems and controls;
●
hire
additional personnel;
●
develop
additional levels of management within our company;
●
locate
additional office space; and
●
maintain
close coordination among our operations, legal, finance, sales and marketing, and client service and support personnel.
As
a result, we may lack the resources to deploy our services on a timely and cost-effective basis. Failure to accomplish any of these requirements
could impair our ability to deliver services in a timely fashion or attract and retain new customers.
If
we make any acquisitions, they may disrupt or have a negative impact on our business.
If
we make acquisitions in the future, we could have difficulty integrating the acquired company’s assets, personnel and operations
with our own. We do not anticipate that any acquisitions or mergers we may enter into in the future would result in a change of control
of the Company. In addition, the key personnel of the acquired business may not be willing to work for us. We cannot predict the effect
expansion may have on our core business. Regardless of whether we are successful in making an acquisition, the negotiations could disrupt
our ongoing business, distract our management and employees and increase our expenses. In addition to the risks described above, acquisitions
are accompanied by a number of inherent risks, including, without limitation, the following:
●
the
difficulty of integrating acquired products, services or operations;
●
the
potential disruption of the ongoing businesses and distraction of our management and the management of acquired companies;
●
difficulties
in maintaining uniform standards, controls, procedures and policies;
●
the
potential impairment of relationships with employees and customers as a result of any integration of new management personnel;
●
the
potential inability or failure to achieve additional sales and enhance our customer base through cross-marketing of the products
to new and existing customers;
●
the
effect of any government regulations which relate to the business acquired;
●
potential
unknown liabilities associated with acquired businesses or product lines, or the need to spend significant amounts to retool, reposition
or modify the marketing and sales of acquired products or operations, or the defense of any litigation, whether or not successful,
resulting from actions of the acquired company prior to our acquisition; and
●
potential
expenses under the labor, environmental and other laws of various jurisdictions.
Our
business could be severely impaired if and to the extent that we are unable to succeed in addressing any of these risks or other problems
encountered in connection with an acquisition, many of which cannot be presently identified. These risks and problems could disrupt our
ongoing business, distract our management and employees, increase our expenses and adversely affect our results of operations.
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Claims,
litigation, government investigations, and other proceedings may adversely affect our business and results of operations.
We
may be subject to actual and threatened claims, litigation, reviews, investigations, and other proceedings, including proceedings relating
to products offered by us and by third parties, and other matters. Any of these types of proceedings, may have an adverse effect on us
because of legal costs, disruption of our operations, diversion of management resources, negative publicity, and other factors. The outcomes
of these matters are inherently unpredictable and subject to significant uncertainties. Determining legal reserves and possible losses
from such matters involves judgment and may not reflect the full range of uncertainties and unpredictable outcomes. Until the final resolution
of such matters, we may be exposed to losses in excess of the amount recorded, and such amounts could be material. Should any of our
estimates and assumptions change or prove to have been incorrect, it could have a material effect on our business, consolidated financial
position, results of operations, or cash flows. In addition, it is possible that a resolution of one or more such proceedings, including
as a result of a settlement, could require us to make substantial future payments, prevent us from offering certain products or services,
require us to change our business practices in a manner materially adverse to our business, requiring development of non-infringing or
otherwise altered products or technologies, damaging our reputation, or otherwise having a material effect on our operations.
We
may incur indebtedness in the future which could reduce our financial flexibility, increase interest expense and adversely impact our
operations and our costs.
We
may incur significant amounts of indebtedness in the future. Our level of indebtedness could affect our operations in several ways, including
the following:
●
a
significant portion of our cash flows is required to be used to service our indebtedness;
●
a
high level of debt increases our vulnerability to general adverse economic and industry conditions;
●
covenants
contained in the agreements governing our outstanding indebtedness limit our ability to borrow additional funds and provide additional
security interests, dispose of assets, pay dividends and make certain investments;
●
a
high level of debt may place us at a competitive disadvantage compared to our competitors that are less leveraged and, therefore,
may be able to take advantage of opportunities that our indebtedness may prevent us from pursuing; and
●
debt
covenants may affect our flexibility in planning for, and reacting to, changes in the economy and in our industry.
A
high level of indebtedness increases the risk that we may default on our debt obligations. We may not be able to generate sufficient
cash flows to pay the principal or interest on our debt, and future working capital, borrowings or equity financing may not be available
to pay or refinance such debt. If we do not have sufficient funds and are otherwise unable to arrange financing, we may have to sell
significant assets or have a portion of our assets foreclosed upon which could have a material adverse effect on our business, financial
condition and results of operations.
Market
and economic conditions may negatively impact our business, financial condition and share price.
Concerns
over medical epidemics, energy costs, geopolitical issues, the U.S. mortgage market and a deteriorating real estate market, unstable
global credit markets and financial conditions, and volatile oil prices have led to periods of significant economic instability, diminished
liquidity and credit availability, declines in consumer confidence and discretionary spending, diminished expectations for the global
economy and expectations of slower global economic growth, increased unemployment rates, and increased credit defaults in recent years.
Our general business strategy may be adversely affected by any such economic downturns, volatile business environments and continued
unstable or unpredictable economic and market conditions. If these conditions continue to deteriorate or do not improve, it may make
any necessary debt or equity financing more difficult to complete, more costly, and more dilutive. Failure to secure any necessary financing
in a timely manner and on favorable terms could have a material adverse effect on our growth strategy, financial performance, and share
price and could require us to delay or abandon development or commercialization plans.
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Future
sales and issuances of our common stock could result in additional dilution of the percentage ownership of our stockholders and could
cause our share price to fall. In addition, the perception that sales of our common stock could occur, could cause our stock price to
fall.
We
expect that significant additional capital will be needed to continue our planned operations, including increased marketing, hiring new
personnel, commercializing our products, and continuing activities as an operating public company. To the extent we raise additional
capital by issuing equity securities, our stockholders may experience substantial dilution. We may sell common stock, convertible securities
or other equity securities in one or more transactions at prices and in a manner we determine from time to time. If we sell common stock,
convertible securities or other equity securities in more than one transaction, investors may be materially diluted by subsequent sales.
Such sales may also result in material dilution to our existing stockholders, and new investors could gain rights superior to our existing
stockholders. Furthermore, sales of a substantial number of our shares of common stock in the public markets or the perception that such
sales could occur, could depress the market price of our common stock and impair our ability to raise capital through the sale of additional
equity securities.
The
number of shares of our common stock available for future issuance or sale could adversely affect the per share trading price of our
common stock.
We
cannot predict whether future issuances or sales of our common stock or the availability of shares for resale in the open market will
decrease the per share trading price of our common stock. The issuance of a substantial number of shares of our common stock in the public
market or the perception that such issuances might occur could adversely affect the per share trading price of our common stock.
We
are an “ emerging growth company ” and will be able to avail ourselves of reduced disclosure requirements applicable
to emerging growth companies, which could make our common stock less attractive to investors.
We
are an “ emerging growth company, ” as defined in the JOBS Act and we intend to take advantage of certain exemptions
from various reporting requirements that are applicable to other public companies that are not “ emerging growth companies ”
including not being required to comply with the auditor attestation requirements of Section 404(b) of the Sarbanes-Oxley Act, reduced
disclosure obligations regarding executive compensation in our periodic reports and proxy statements, and exemptions from the requirements
of holding a nonbinding advisory vote on executive compensation and stockholder approval of any golden parachute payments not previously
approved. In addition, pursuant to Section 107 of the JOBS Act, as an “ emerging growth company ” we intend to take
advantage of the extended transition period provided in Section 7(a)(2)(B) of the Securities Act, for complying with new or revised accounting
standards. In other words, an “ emerging growth company ” can delay the adoption of certain accounting standards until
those standards would otherwise apply to private companies. We cannot predict if investors will find our common stock less attractive
because we may rely on these exemptions. If some investors find our common stock less attractive as a result, there may be a less active
trading market for our common stock and our stock price may be more volatile. We may take advantage of these reporting exemptions until
we are no longer an “ emerging growth company. ” We will remain an “ emerging growth company ” until
the earliest of (i) the last day of the fiscal year in which we have total annual gross revenues of $1.235 billion or more; (ii) the
last day of our fiscal year following the fifth anniversary of the date of the completion of our initial public offering (i.e., December
31, 2028); (iii) the date on which we have issued more than $1 billion in nonconvertible debt during the previous three years; or (iv)
the date on which we are deemed to be a large accelerated filer under the rules of the SEC.
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Financial
reporting obligations of being a public company in the U.S. are expensive and time-consuming, and our management will be required to
devote substantial time to compliance matters.
As
a publicly-traded company we incur significant additional legal, accounting and other expenses. The obligations of being a public company
in the U.S. require significant expenditures and place significant demands on our management and other personnel, including costs resulting
from public company reporting obligations under the Exchange Act and the rules and regulations regarding corporate governance practices,
including those under the Sarbanes-Oxley Act, the Dodd-Frank Wall Street Reform and Consumer Protection Act, and the listing requirements
of The Nasdaq Capital Market. These rules require the establishment and maintenance of effective disclosure and financial controls and
procedures, internal control over financial reporting and changes in corporate governance practices, among many other complex rules that
are often difficult to implement, monitor and maintain compliance with. Moreover, despite recent reforms made possible by the JOBS Act,
the reporting requirements, rules, and regulations will make some activities more time-consuming and costly, particularly after we are
no longer an “ emerging growth company ” or a “ smaller reporting company. ” Our management and other
personnel will need to devote a substantial amount of time to ensure that we comply with all of these requirements and to keep pace with
new regulations, otherwise we may fall out of compliance and risk becoming subject to litigation or being delisted, among other potential
problems.
For
all of the foregoing reasons and others set forth herein, an investment in our securities involves a high degree of risk.
Item
1B. Unresolved Staff Comments.
None.
Item 1C. Cybersecurity
The
Company understands the importance of preventing, assessing, identifying, and managing material risks associated with cybersecurity threats.
Cybersecurity processes to assess, identify and manage risks from cybersecurity threats have been incorporated as a part of the Company’s
overall risk assessment process. These risks include, among other things: operational risks, intellectual property theft, fraud, extortion,
harm to employees or customers and violation of data privacy or security laws.
We
have processes in place to identify, assess and monitor material risks from cybersecurity threats, including the material risks of the
Company. These processes are part of our overall enterprise risk management process and have been embedded in our operating procedures,
internal controls and information systems. On a regular basis we implement into our operations these cybersecurity processes, technologies,
and controls to assess, identify, and manage material risks. Cybersecurity risks related to our business, technical operations, privacy
and compliance issues are identified and addressed through a multi-faceted approach including third party assessments, IT security, governance,
risk and compliance reviews. To defend, detect and respond to cybersecurity incidents, we, among other things, have retained an outsourced
software firm that has provided.
The
Company’s technology platform and application is hosted on Amazon Web Services (AWS) with a Virtual Desktop Infrastructure (VDI)
and operates on Linux. The application architecture is designed with security as a priority, leveraging AWS’s robust infrastructure.
We utilize an Amazon Relational Database Service (AWS RDS) for data storage, which resides within a private network to safeguard sensitive
information. Only the front-end interface is exposed to the internet, while the rest of the application stack remains shielded behind
AWS’s firewall. We believe that this setup effectively blocks unauthorized external access, ensuring that only legitimate user
requests reach our application.
To
further enhance security and prevent data breaches, our platform mandates the use of a .pem file for any connection to services within
the platform, adding an extra layer of authentication. All client-server communications are encrypted using SSL (Secure Socket Layer),
which ensures that all data transmitted over the internet is secure and protected from interception. Additionally, we employ AWS Shield
for defense against Distributed Denial of Service (DDoS) attacks, which are increasingly common threats to online platforms. This comprehensive
approach to security ensures that our platform remains resilient against attacks, protecting both our infrastructure and our users’
sensitive information.
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Moreover,
the communication between the front-end and backend components of our platform is secured with security tokens, which prevent unauthorized
access and ensure that only authenticated requests are processed. Personal information required for integrations with external systems
is encrypted using hash algorithms, further securing data at rest and in transit. These security practices highlight our commitment to
maintaining the confidentiality, integrity, and availability of user data. Our adherence to best security practices and utilization of
AWS’s advanced security features showcase our platform as a secure and reliable solution for customers seeking privacy and protection
while purchasing sensitive health-related products.
Incidents
are evaluated to determine materiality as well as operational and business impact, and reviewed for privacy impact.
We
describe whether and how risks from identified cybersecurity threats, including as a result of any previous cybersecurity incidents,
have materially affected or are reasonably likely to materially affect us, including our business strategy, results of operations, or
financial condition, under the heading “ Security breaches, loss of data and other disruptions could compromise sensitive
information related to our business or customers, or prevent us from accessing critical information and expose us to liability, which
could adversely affect our business and our reputation ” included as part of our risk factor disclosures at Item 1A of this
Annual Report on Form 10-K.
Cybersecurity
is an important part of our risk management processes and an area of focus for our Board and management.
Our
Chief Operating Officer and our Director of E-Commerce are responsible for the oversight of risks from cybersecurity threats . The Board receives information and updates periodically with respect to the effectiveness of our cybersecurity and information security framework,
data privacy and risk management . The Board will also be provided updates on any material incidents relating to information systems security
and cybersecurity incidents.
As
of and for the year ended December 31, 2024, there have been no cybersecurity incidents that have materially affected the Company’s
business strategy, results of operations, or financial condition.
Item
2. Properties.
On
September 28, 2022, and with an effective date of October 1, 2022, the Company entered into a Lease Agreement with Rox Trep Tollway,
L.P. (the “ Landlord ”) to lease and occupy approximately 2,201 square feet of office space located at 15110 N. Dallas
Parkway, Suite 600, Dallas, Texas 75248 to serve as the Company’s main headquarters (the “ Lease Agreement ”).
The Lease Agreement has a term of 38 months (through December 31, 2025) and has a monthly base rent of $0 for the second month; $5,778,
or $31.50 per square foot, for months 1 and 3-18 and increases at the rate of $1 per square foot per annum thereafter until the end of
the lease term (the “ Base Rent ”). In addition to the Base Rent, the Company is required to reimburse the landlord
for its pro-rata share of all real estate taxes and assessments, hazard and liability insurance and common area maintenance costs for
the building at the rate of 2.45% (the “ Proportionate Rent ”). Upon the execution of the Lease Agreement, the Company
agreed to prepay the first full month’s Base Rent along with a security deposit equal to $16,942. The lease includes an option
to extend the lease for an additional period of 36 calendar months at market.
We
believe our facilities are sufficient to meet our current needs and that suitable space will be available as and when needed. We do not
own any real property.
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Item
3. Legal Proceedings.
On
October 31, 2024, Eli Lilly and Company filed a complaint against us in the Northern District of Texas Dallas Division. The complaint
alleges causes of action against us for false and misleading advertising and promotion in violation of Section 43(a)(1)(B) of the Lanham
Act; and false advertising, in connection with the Company’s TRIM product, and seeks (a) a declaratory judgment, an injunction
from falsely stating or suggesting that our oral dissolvable tirzepatide tablets are approved by FDA, have been the subject of clinical
studies, or achieve certain therapeutic outcomes; engaging in any unfair competition with Eli Lilly; and engaging in any deceptive or
unfair acts; (b) an order requiring the Company and its officers, agents, servants, employees, and attorneys and all persons acting in
concert or participation with any of them, to engage in corrective advertising by informing consumers that: a. our oral dissolvable tirzepatide
tablets do not contain the same formulation as MOUNJARO® or ZEPBOUND®; our oral dissolvable tirzepatide tablets do not contain
the same dosage as MOUNJARO® or ZEPBOUND®; our oral dissolvable tirzepatide tablets are not and have never been approved by FDA;
our oral dissolvable tirzepatide tablets have never been studied in clinical trials; and our oral dissolvable tirzepatide tablets have
never been demonstrated to be safe or effective; (c) an order directing the Company to file with the court and serve on Eli Lilly’s
attorneys, thirty (30) days after the date of entry of any injunction, a report in writing and under oath setting forth in detail the
manner and form in which it has complied with the court’s injunction; (e) an order requiring the Company to account for and pay
to Eli Lilly any and all profits arising from the foregoing acts of alleged false advertising; (f) an order requiring the Company to
pay Eli Lilly compensatory damages in an amount as of yet undetermined caused by the false advertising and trebling such compensatory
damages for payment to Lilly in accordance with 15 U.S.C. § 1117 and other applicable laws; (f) an order requiring the Company to
pay Eli Lilly all types of monetary remedies available under Texas state law in amounts as of yet undetermined caused by the foregoing
acts of unfair competition; (g) pre-judgment and post-judgment interest on all damages; and (h) attorney’s fees.
The
initial Complaint asserted two claims: (i) false advertising under the federal Lanham Act; and (ii) common law deceptive advertising.
The Company moved to dismiss the second claim, arguing that Texas does not recognize such a claim. Thereafter on January 30, 2025, Eli
Lilly responded by filing an amended complaint wherein it removed the 2 nd cause of action. On February 24, 2025, the Company filed its response along with its affirmative defenses and concluding with a
motion to dismiss.
When
the Action was filed, management responded by making changes to its website; specifically, removing the allegedly offending references
to FDA studies. The product is no longer identified on the MangoRx website, the product cannot
be purchased and no sales have been made. The Company, by and through counsel, has been attempting to resolve the matter, but intends
to vigorously defend the matter if an early resolution is not reached.
The
impact and outcome of litigation is subject to inherent uncertainties, and an adverse result in these or other matters may arise from
time to time that may harm our business. The above claims and others, even if lacking merit, could result in the expenditure by us of
significant financial and managerial resources. We may become involved in additional material legal proceedings in the future.
Item
4. Mine Safety Disclosures.
Not
applicable.
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PART
II
Item
5. Market for Registrant’s Common Equity, Related Shareholder Matters and Issuer Purchases of Equity Securities.
Market
Information
Our
common stock is presently traded on The Nasdaq Capital Market under the symbol “ MGRX ”. As of the date of this filing
we had 5,168,796 shares of common stock issued and outstanding.
Holders
According
to the records of our transfer agent, as of the date of this Report, there were approximately 40 record holders of our common stock.
The number of record holders does not include beneficial owners of common stock whose shares are held in the names of banks, brokers,
nominees, or other fiduciaries.
Dividends
We
have never paid any cash dividends on our common stock. We currently anticipate that we will retain all future earnings for use in our
business. Consequently, we do not anticipate paying any cash dividends in the foreseeable future. The payment of dividends in the future
will depend upon our results of operations, as well as our short-term and long-term cash availability, working capital, working capital
needs, and other factors as determined by our Board of Directors. Currently, except as may be provided by applicable laws, there are
no contractual or other restrictions on our ability to pay dividends if we were to decide to declare and pay them.
Recent
sales of unregistered securities
There
have been no sales of unregistered securities during the quarter ended December 31, 2024, and from the period from January 1, 2025 to
the filing date of this Report which have not previously been disclosed in a Current Report on Form 8-K or Quarterly Report on Form 10-Q.
Issuer
Repurchases of Equity Securities
None.
Item
6. [Reserved]
Item
7. Management’s Discussion and Analysis of Financial Condition and Results of Operations.
Forward-looking
statements
The
following discussion of the Company’s historical performance and financial condition should be read together with the consolidated
financial statements and related notes in “ Item 8. Financial Statements and Supplemental Data ” of this Report. This discussion
contains forward-looking statements based on the views and beliefs of our management, as well as assumptions and estimates made by our
management. These statements by their nature are subject to risks and uncertainties, and are influenced by various factors. As a consequence,
actual results may differ materially from those in the forward-looking statements. See “ Item 1A. Risk Factors ” of this Report
for the discussion of risk factors and see “ Cautionary Statement Regarding Forward-Looking Statements ” for information on
the forward-looking statements included below.
The
following discussion is based upon our consolidated financial statements included elsewhere in this Report, which have been prepared in accordance
with U.S. generally accepted accounting principles. The preparation of these financial statements requires us to make estimates and judgments
that affect the reported amounts of assets, liabilities, revenues and expenses, and related disclosure of contingencies.
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Introduction
Our
Management’s Discussion and Analysis of Financial Condition and Results of Operations (“ MD&A ”) is provided
in addition to the accompanying consolidated financial statements and notes to assist readers in understanding our results of operations, financial
condition, and cash flows. MD&A is organized as follows:
●
Key
Performance Indicators. Indicators describing our performance for the periods presented.
●
Plan
of Operations. A description of our plan of operations for the next 12 months including required funding.
●
Results
of Operations. An analysis of our financial results comparing the years ended December 31, 2024 and 2023.
●
Liquidity
and Capital Resources. An analysis of changes in our balance sheets and cash flows and discussion of our financial condition.
●
Critical
Accounting Policies and Estimates. Accounting estimates that we believe are important to understanding the assumptions and
judgments incorporated in our reported financial results and forecasts.
See
also “ Glossary of Industry Terms ” above for information on certain of the terms used below.
Plan
of Operations
We
had working capital deficit of $1.3 million as of December 31, 2024. With our current cash on hand, expected revenues, and based on our
current average monthly expenses, we currently anticipate the need for additional funding in order to continue our operations at their
current levels and to pay the costs associated with being a public company for the next 12 months. We may also require additional funding
in the future to expand or complete acquisitions.
Our
plan for the next 12 months is to continue using the same marketing and management strategies and continue providing a quality product
with excellent customer service while also seeking to expand our operations organically or through acquisitions as funding and opportunities
arise. As our business continues to grow, customer feedback will be integral in making small adjustments to improve products and our
overall customer experience.
We
are headquartered in Dallas, Texas and intend to grow our business both organically and through identifying acquisition targets over
the next 12 months in the technology, health and wellness space, funding permitting. Specifically, we plan to continue to make additional
and ongoing technology enhancements to our platform, further develop, market and advertise additional men’s health and wellness
related products on our telemedicine platform, and identify strategic acquisitions that complement our vision. As these opportunities
arise, we will determine the best method for financing such acquisitions and growth which may include the issuance of debt instruments,
common stock, preferred stock, or a combination thereof, all of which may result in significant dilution to existing shareholders.
We
may seek additional funding in the future through equity financings, debt financings or other capital sources, including collaborations
with other companies or other strategic transactions. We may not be able to obtain financing on acceptable terms or at all. The terms
of any financing may adversely affect the holdings or rights of our shareholders and/or create significant dilution. Although we continue
to pursue these plans, there is no assurance that we will be successful in obtaining sufficient funding on terms acceptable to us to
fund continued operations, if at all.
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Strategic
Alternatives
In
October 2024, the Board of Directors of the Company initiated a process to evaluate potential strategic alternatives with the intent
to unlock and maximize shareholder value, including but not limited to potential mergers, acquisitions, divestitures and business combinations,
acquisitions of businesses, entry into new lines of business, business expansions, joint ventures, and other key strategic transactions
outside the ordinary course of the Company’s current business. This initiative is being be undertaken in parallel with the Company’s
current business operations. In consultation with financial and legal advisors, the Company intends to consider a broad range of strategic,
operational and financial alternatives, and is exploring a full range of options. There is no assurance that the strategic review process
will result in the approval or completion of any specific transaction or outcome. The Company has not established a timeline for completion
of the review process and does not intend to comment further unless and until its Board of Directors has approved a definitive course
of action, or it is determined that other disclosure is necessary or appropriate.
Results
of Operations
We
had revenues of $615,873 for the year ended December 31, 2024, compared to revenues of $731,493 for the year ended December 31, 2023,
which decrease was mainly due to issued involving the transition and migration from our original telemedicine and software platform to
our new telehealth platform.
Cost
of revenues was $93,296 and $154,900 for the years ended December 31, 2024 and 2023, respectively, which decrease was due to and in correlation
with our decreased revenues for the same period.
Cost
of revenues – related party, representing amounts paid to Epiq Scripts, our related party pharmacy for pharmacy services, totaled
$142,613 and $145,092 for the years ended December 31, 2024 and 2023, which slight decrease in the current period was due to our decreased
revenues for the same period.
During 2024, we further developed our website capabilities and prepared
for our re-launch of our website. Travel expenses of $199,822 and $301 170, for the years ended December 31, 2024 and 2023, respectively,
related to cost associated with meeting with vendors, travel for promotional events and other travel related expenses. We had a loss on
sale of assets of $18,387 for the year ended December 31, 2024, compared to $0 for the year ended December 31, 2023. On May 15, 2024,
the Company disposed of $119,819 of equipment to Epiq Scripts, a related party, in an arm’s length transaction. The equipment was
sold for $65,000, realizing a loss on sale of assets of $18,387.
Advertising
and marketing expenses in the amount of $1,478,663 and $2,097,505, for the years ended December 31, 2024 and 2023, respectively, related
to digital marketing and advertising expenses, various branding initiatives and promotional events. The decrease was related to a reduction
in advertising and marketing, while we develop our internal software front and backend development of our website re-launch.;
Salaries and benefits were $1,063,781 and $977,890 for the years ended
December 31, 2024 and 2023, respectively, which increase was due to the engagement of new employees as we ramped up our internal operations
in the current period.
Investor relations expenses were $453,749 and $1,100,465, for the years
ended December 31, 2024 and 2023, respectively, related to awareness of our stock to the public market. The decrease was due to lowering
costs after our initial IPO in 2023.
Stock-based
compensation totaled $2,355,193 and $2,155,114 (including a total of $2,106,265 and $1,530,659 attributed to stock issued for services
and $248,682 and $624,463 attributed to stock-based compensation from issuances of options and warrants) for the years ended December
31, 2024 and 2023, respectively, which increase was due to us having issued less stock for compensation during the 2023 period.
We had $13,700 and $0 of interest expense for the year ended December 31,
2024 and 2023 respectively, compared to interest income of $0 and $6,473 for the year ended December 31, 2024 and 2023, respectively,
which increase in interest expense was due to interest accrued on certain notes payable during the 2024 period and an increase
in imputed interest income was related to cancelation of imputed interest from repayment of related party notes payable during 2023.
We had $721,533 and $0 of amortization expense for the year ended December
31, 2024 and 2023, respectively, in connection with the amortization of our patents.
We had a net loss of $8,707,226 for the year ended December 31, 2024, compared
to a net loss of $9,212,417 for the year ended December 31, 2023, a decrease in net loss of $505,191 from the prior period due to less
overall expenses required to operate the business during the 2024 period.
Liquidity
and Capital Resources
As of December 31, 2024, we had $58,653 of cash on-hand, compared to $739,006
of cash on-hand of December 31, 2023. We also had $16,942 of security deposit, representing the security deposit on our leased office
space and $59,493 of right of use asset in connection with our office space lease. $2,806 of property and equipment, net, consisting of
computers, office and custom product packaging equipment. and $15,232,617 of patents, net of amortization, which we acquired pursuant
to the Patent Purchase Agreements described in greater detail above under “Item 1. Business— Material Agreements—Patent Purchase Agreements .”
Cash decreased mainly due to funds used for general operating expenses.
As of December 31, 2024, the Company had total current liabilities of $1,425,463,
consisting of $837,501 of accounts payable and accrued liabilities, $64,962 of right-of-use liability, operating lease, notes payable
of $150,000 (discussed below), and $373,000 of other liabilities related to amounts owed to Intramont in connection with the purchase
of intellectual property.
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As
of December 31, 2024, we had $16,092,044 in total assets, $1,425,463 in total liabilities, working capital deficit of $1.3 million and
a total accumulated deficit of $20,806,595.
We have mainly relied on related party loans, as well as funds raised through
the sale of securities, mainly through the private placement offerings, our IPO and our Follow On Offering, each discussed below, and
revenues generated from sales of our Pharmaceutical Products, to support our operations since inception. We have primarily used our available
cash to pay operating expenses. We do not have any material commitments for capital expenditures.
We have experienced recurring net losses since inception. We believe that
we will continue to incur substantial operating expenses in the foreseeable future as we continue to invest to market and sell our Pharmaceutical
Products and to attract customers, expand the product offerings and enhance technology and infrastructure. These efforts may prove more
expensive than we anticipate, and we may not succeed in generating commercial revenues or net income to offset these expenses. Accordingly,
we may not be able to achieve profitability, and we may incur significant losses for the foreseeable future. Our independent registered
public accounting firm included an explanatory paragraph in its report on our consolidated financial statements as of December 31, 2024. As of December
31, 2024, our current capital resources, combined with the net proceeds from the offering, are not expected to be sufficient for us to
fund operations for the next 12 months. We need to raise funding in addition to the funding raised in our IPO and Follow On Offering,
to support our operations in the future. We may also seek to acquire additional businesses or assets in the future, which may require
us to raise funding. We currently anticipate such funding being raised through the offering of debt or equity. Such additional financing,
if required, may not be available on favorable terms, if at all. If debt financing is available and obtained, our interest expense may
increase and we may be subject to the risk of default, depending on the terms of such financing. If equity financing is available and
obtained it may result in our shareholders experiencing significant dilution. If such financing is unavailable, we may be forced to curtail
our business plan, which may cause the value of our securities to decline in value. We currently have availability of approximately $23.8
million under the ELOC, which funding we may request from the Purchaser from time to time, subject to the terms thereof, and which funding,
if requested may cause dilution to existing shareholders. Additionally, we may receive funding upon the exercise of outstanding warrants
from time to time, which exercises may cause dilution to existing shareholders.
To support our existing operations or any future expansion of business,
including the ability to execute our growth strategy, we must have sufficient capital to continue to make investments and fund operations.
We have plans to pursue an aggressive growth strategy for the expansion of operations through marketing to attract new customers for our
Pharmaceutical Products.
Cash
Flows
Year ended
December 31,
2024
Year ended
December 31,
2023
Cash provided by (used in):
Operating activities
$ (4,863,776 )
$ (6,997,375 )
Investing activities
65,000
(3,519 )
Financing activities
4,128,268
7,057,040
Net increase (decrease) in cash
$ (670,508 )
$ 56,146
Net cash used in operating activities was $4,863,776 for the year ended
December 31, 2024, which was mainly due to $8,707,226 of net loss, offset by $2,106,265 of common stock issued for services, $248,682
of options vested for stock-based compensation and $721,533 for amortization of intangible assets.
Net
cash used in operating activities was $6,997,375 for the year ended December 31, 2023, which was mainly due to $9,212,417 of net loss,
offset by $1,530,651 of common stock issued for services, and $624,563 of options vested for stock-based compensation.
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Net
cash provided by investing activities was $65,000 for the year ended December 31, 2024, compared to $3,519 used in investing activities
for the year ended December 31, 2023, which were for the sale of equipment and the purchase of equipment, respectively.
Net
cash provided by financing activities was $4,128,268 for the year ended December 31, 2024, which was mainly due to $2,650,000 of funds
raised from the sale of preferred stock for cash, $1,328,268 from the sale of common stock for cash and $150,000 in notes payable.
Net
cash provided by financing activities was $7,057,040 for the year ended December 31, 2023, which was mainly due to $6,200,000 of funds
raised in the IPO and Follow On Funding and $1,024,500 in proceeds from the exercise of warrants, offset by repayments of notes payable
of $78,260 and repayments of related party notes payable of $89,200.
Related
Party Loans and Advances
The
Company has previously received various related party loans and advances which are discussed in greater detail below under “ Item
13. Certain Relationships and Related Transactions, and Director Independence—Related Party Transactions—Related Party Loans
and Advances ”.
Convertible
Debt
On
October 18, 2024, the Company entered into a $150,000 promissory note (the “Cohen Note”) with Cohen Enterprises, Inc. to
evidence, document and memorialize (a) $50,000 loaned to the Company from Cohen Enterprises on March 18, 2024, and (b) $100,000 loaned
to the Company from Cohen Enterprises on April 1, 2024, which amounts previously accrued no interest and were due on demand. The Cohen
Note in the principal amount of $150,000, accrues interest at the rate of 8% per annum (12% upon the occurrence of an event of default),
with interest accruing monthly in arrears and payable at maturity or earlier acceleration. The Cohen Note is due upon the earlier of
January 2, 2025, and upon acceleration by Cohen Enterprises pursuant to the terms thereof upon default, or automatically upon certain
bankruptcy events occurring. The Cohen Note may be prepaid without penalty, is unsecured and contains customary representations and covenants
of the Company. The note includes customary events of default, and allows Cohen Enterprises the right to accelerate the amount due under
the note upon the occurrence of such event of default, subject to certain cure rights.
On
December 13, 2024, Cohen Enterprises entered into a Note Purchase Agreement with Mill End Capital Ltd. (“ Mill End ”
and the “ Note Purchase ”). Pursuant to the Note Purchase, Mill End purchased all of Cohen Enterprises rights under
the Cohen Note, issued by the Company as borrower, to Cohen Enterprises, as lender, in the original amount of $150,000, in consideration
for $150,000. The terms of the note remain unchanged, however, the note is no longer considered a related party note.
On
January 15, 2025, the Company entered into a Debt Conversion Agreement (the “ Debt Conversion Agreement ”) with Mill
End. Pursuant to the Debt Conversion Agreement, the Company and Mill End agreed to convert the entire $150,000 owed by the Company
under the Promissory Note (the “ Converted Note ”), into an aggregate of 100,000 shares of restricted common stock of
the Company (the “Debt Conversion Shares”), based on an agreed conversion price of $1.50 per share.
Pursuant
to the Debt Conversion Agreement, which included customary representations and warranties of the parties, Mill End agreed that the shares
of common stock issuable in connection therewith were in full and complete satisfaction of amounts owed under the Converted Note.
On
January 27, 2025, the Company entered into a First Amendment to Payment Plan Letter Agreement (the “ 1 st Amendment ”)
with MAAB Global Ltd. (“ MAAB ”). MAAB had previously purchased rights to $500,000 owed by the Company to Barstool Sports,
Inc. (“ Barstool ” and the “ Debt ”) on January 10, 2025, which amount was non-interest bearing, and
due pursuant to the terms of a Payment Plan Letter Agreement entered into between Barstool and the Company on August 27, 2024.
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Pursuant
to the 1 st Amendment, the Company and MAAB agreed to amend the terms of the Debt to allow MAAB the right, exercisable
at any time, to convert the $500,000 of Debt into shares of the Company’s common stock at a conversion price of $1.50 per share.
As
a result of the conversion of the Promissory Note, pursuant to the terms of the Debt Conversion Agreement, at a conversion price of $1.50
per share, the exercise price of those certain common stock warrants issued by the Company in connection with its December 2025 Series
B Convertible Preferred Stock offering (warrants to purchase up to 1,650,000 shares of common stock with exercise prices from between
$2.59 and $2.71 per share); and those certain common stock warrants to purchase 320,000 shares of common stock granted to the Purchaser
in connection with the SPA (with an exercise price of $2.53 per share), were automatically re-priced pursuant to the anti-dilutive terms
thereof, to have an exercise price equal to the Conversion Price of the Debt Conversion Agreement, $1.50 per share, effective upon the
date of the Debt Conversion Agreement.
Additionally,
as a result of the conversion of the Promissory Note, pursuant to the terms of the Debt Conversion Agreement, at a conversion price of
$1.50 per share, the conversion price of the Company’s Series B Preferred Stock was automatically adjusted, pursuant to the designation
of such Series B Preferred Stock, to have a conversion price of $2.25 per share, the floor price thereunder, effective upon the date
of the Debt Conversion Agreement.
Funding
Arrangements
2022
Private Placement
In
August 2022, the Company initiated a private placement of up to $2 million of units to accredited investors, with each unit consisting
of one-fifteenth of one share of common stock and a warrant to purchase one-fifteenth of one share of common stock, at a price of $1.00
per unit. The warrants have a five-year term (from each closing date that units were sold) and an exercise price of $15.00 per whole
share. If at any time after the six-month anniversary of the issuance date, there is no effective registration statement registering,
or no current prospectus available for the resale of the shares of common stock issuable upon exercise the warrants, the holder of the
warrants may elect a cashless exercise of the warrants. Boustead Securities, LLC, the representative of the underwriters in our initial
public offering (“ IPO ”), served as the placement agent in connection with the private placement. In total, we sold
an aggregate of 2,000,000 units for $2,000,000 to 23 accredited investors between August 16, 2022 and December 22, 2022, the end date
of the offering.
Initial
Public Offering
On
March 23, 2023, we consummated our IPO of 83,334 shares of common stock at a price to the public of $60.00 per share, pursuant to that
certain Underwriting Agreement, dated March 20, 2023 (the “ Underwriting Agreement ”), between the Company and Boustead
Securities, LLC, as representative (“ Boustead ”) of several underwriters named in the Underwriting Agreement. The Company
received gross proceeds of approximately $5 million, before deducting underwriting discounts and commissions and estimated offering expenses
payable by the Company upon the sale of the shares. In connection with the IPO, the Company also granted Boustead a 45-day option to
purchase up to an additional 12,500 shares of its common stock, which expired unexercised.
At
the same time, and as part of the same registration statement, but pursuant to a separate prospectus (the “ Resale Prospectus ”)
the Company registered the sale of 317,667 shares of common stock, including 133,334 shares of common stock issuable upon the exercise
of outstanding warrants to purchase shares of common stock with an exercise price of $15.00 per share, of which warrants to purchase
65,033 shares of common stock remain outstanding, and unexercised, as of the date of this Report.
As
additional consideration in connection with the IPO, we granted Boustead, the representative of the underwriters named in the Underwriting
Agreement for the IPO, warrants to purchase 5,834 shares of common stock with an exercise price of $75.00 per share, which are exercisable
beginning six months after the effective date of the registration statement filed in connection with the IPO (March 20, 2023) and expire
five years after such effectiveness date.
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Follow
On Offering
On
December 15, 2023, we entered into another underwriting agreement (the “ Underwriting Agreement ”) with Boustead, as
representative of the underwriters named on Schedule 1 thereto (the “ Underwriters ”), relating to a public
offering of 266,667 shares of the Company’s common stock to the Underwriters at a purchase price to the public of $4.50 per share
and also granted to the Underwriters a 45-day option to purchase up to 40,000 additional shares of its common stock, solely to cover
over-allotments, if any, at the public offering price less the underwriting discounts (the “ Follow On Offering ”).
The
Follow On Offering closed on December 19, 2023. As a result, the Company sold 266,667 shares of its common stock for total gross proceeds
of $1.2 million.
The
net proceeds to the Company from the Offering, after deducting the underwriting discounts and commissions and offering expenses, were
approximately $1.0 million. The Company used the net proceeds from the Offering to finance the marketing and operational expenses associated
with its Mango ED and GROW hair growth products, to hire additional personnel to build organizational talent, to develop and maintain
software, and for working capital and other general corporate purposes.
On
December 19, 2023, pursuant to the Underwriting Agreement, the Company issued a common stock purchase warrant to Boustead for the purchase
of 18,667 shares of common stock at an exercise price of $5.70, subject to adjustments. The warrant is exercisable at any time and from
time to time, in whole or in part, until December 14, 2029, and may be exercised on a cashless basis.
On
January 18, 2024, the Underwriters notified the Company that they were exercising their over-allotment option in full to purchase an
additional 40,000 shares of common stock, which sale closed on January 22, 2024. The net proceeds to the Company from the sale of the
40,000 shares of common stock, after deducting underwriting discounts and expenses, was approximately $160,000. Inclusive of the full
exercise of the over-allotment option, a total of 306,667 shares of common stock were issued and sold in the Offering.
On
January 22, 2024, pursuant to the Underwriting Agreement, the Company also issued a common stock purchase warrant to Boustead for the
purchase of 2,800 shares of common stock at an exercise price of $5.625, subject to adjustments. The warrant is exercisable at any time
and from time to time, in whole or in part, until December 14, 2028, and may be exercised on a cashless basis.
April
2024 Securities Purchase Agreement
Effective
on April 5, 2024 (the “ Initial Closing Date ”), we agreed to definitive terms on a Securities Purchase Agreement dated
April 4, 2024 (as amended from time to time, the “ SPA ”), with an institutional accredited investor (the “ Purchaser ”),
pursuant to which the Company agreed to sell to the Purchaser, and the Purchaser agreed to purchase from the Company, 1,500 shares of
Series B Convertible Preferred Stock (“ Series B Preferred Stock ”) of the Company for $1,650,000, and warrants (the
“ Initial Warrants ”), to purchase up to 220,000 shares of common stock, of the Company, for an aggregate purchase price
of $1,500,000. On the Initial Closing Date, the Company sold the Purchaser 500 shares of Series B Preferred Stock (the “Initial
Closing Shares”) and the Initial Warrants, for an aggregate of $500,000. The Initial Warrants have a term of five years.
On
April 26, 2024, the Company partially closed a planned second closing under the SPA (the “Second Closing”), the Purchaser
paid $150,000 to the Company, and in consideration therefore the Company issued the Purchaser 150 shares of Series B Preferred Stock.
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On
May 17, 2024, the Company closed the remaining portion of the Second Closing, the Purchaser paid $100,000 to the Company, and in consideration
therefore the Company issued the Purchaser 100 shares of Series B Preferred Stock.
On
April 28, 2024, the Company and the Purchaser entered into an Omnibus Amendment Agreement No. 1 (the “ Amendment ”),
which amended the SPA to, adjust the closings which were to take place under the SPA as follows:
#
Initial Stated Value of
Preferred Stock to be issued
by installment
Warrants to be issued
Closing Date
Aggregate Purchase
Price by
installment
(USD)
Initial Closing
$ 550,000
220,000
Initial Closing Date
$ 500,000
Second Closing
$ 275,000
On or before June 30, 2024 (the “ Second Closing Date ”)
$ 250,000
Third Closing
$ 825,000
100,000
On or before June 30, 2024
$ 750,000
Fourth Closing
$ 1,100,000
Such date as is no later than 180 days (the “ Fourth Closing Date ”) after the shares of Common Stock issuable in respect of the Series B Preferred Stock sold in each of the Initial Closing, Second Closing, the Third Closing, and the Fourth Closing have been registered under the Securities Act, subject to any limitations pursuant to Rule 415 (as defined in the Registration Rights Agreement)
$ 1,000,000.00
Total
$ 2,750,000
320,000
$ 2,500,000
On
April 26, 2024, the Company partially closed the Second Closing. The Purchaser paid $150,000 to the Company and in consideration therefore
the Company issued the Purchaser 150 shares of Series B Preferred Stock.
On
May 17, 2024, the Company closed the remaining portion of the Second Closing. The Purchaser paid $100,000 to the Company and in consideration
therefore the Company issued the Purchaser 100 shares of Series B Preferred Stock.
On
May 21, 2024, the Purchaser converted 50 shares of Series B Preferred Stock into 18,063 shares of Common Stock of the Company, pursuant
to the terms of such Series B Preferred Stock.
On
May 22, 2024, the Purchaser converted 155 shares of Series B Preferred Stock into 55,994 shares of Common Stock of the Company, pursuant
to the terms of such Series B Preferred Stock.
On
May 24, 2024, the Purchaser converted 150 shares of Series B Preferred Stock into 54,188 shares of Common Stock of the Company, pursuant
to the terms of such Series B Preferred Stock.
On
July 9, 2024, the Purchaser converted 135 shares of Series B Preferred Stock into 35,779 shares of Common Stock of the Company, pursuant
to the terms of such Series B Preferred Stock.
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On
July 25, 2024, the Purchaser converted 10 shares of Series B Preferred Stock into 2,245 shares of Common
Stock of the Company, pursuant to the terms of such Series B Preferred Stock.
On
June 28, 2024 (the “ Third Closing Date ”), the Company sold the Purchaser 750 shares of Series B Preferred Stock (the
“ Third Closing Shares ”) and (a) warrants to purchase up to 66,667 shares of common stock at an exercise price of $7.50
per share; and (b) warrants to purchase up to 33,333 shares of common stock at an exercise price of $15.00 per share (collectively, (a)
and (b), the “ Additional Warrants ”, and together with the Initial Warrants, the “ Warrants ”, and
the shares of common stock issuable upon exercise of the Warrants, the “ Warrant Shares ”). The Additional Warrants
were exercisable on or after October 4, 2024, and for five years thereafter.
If
at any time the Warrants are outstanding there occurs any share split, share dividend, share combination recapitalization or other similar
transaction involving the common stock (each, a “ Share Combination Event ”, and such date thereof, the “ Share
Combination Event Date ”) and the Event Market Price (defined below) is less than the then exercise price then in effect, then
on the sixth trading day immediately following such Share Combination Event Date, the Exercise Price then in effect on such sixth trading
day is automatically reduced (but in no event increased) to the Event Market Price. The “ Event Market Price ” means,
with respect to any Share Combination Event Date, the quotient determined by dividing (x) the sum of the volume weighted average price
of the common stock for each of the five trading days ending and including the trading day immediately preceding the sixth trading day
after such Share Combination Event Date, divided by (y) five. In connection with the Reverse Stock Split, the exercise price of the Warrants
was automatically adjusted to $2.53 per share, and has subsequently been adjusted to $1.50 per share as a result of certain dilutive
issuances.
On
August 22, 2024, the conditions to closing were satisfied, and the Company sold the Purchaser an additional 500 shares of Series B Preferred
Stock (“ Fourth Closing Shares ”) for $500,000 in connection with a partial closing of the Fourth Closing.
On
September 26, 2024, the Company sold the Purchaser an additional 250 shares of Series B Preferred Stock (the “ Additional Fourth
Closing Shares ”) for $250,000 in connection with a partial closing of the Fourth Closing.
On
September 26, 2024, 140 shares of Series B Preferred Stock (with an aggregate stated value of $154,000) were converted by the holder
into 47,903 shares of common stock at a conversion price of $3.21 per share.
On
October 2, 2024, 190 shares of Series B Preferred Stock (with an aggregate stated value of $209,000) were converted by the holder into
66,923 shares of common stock at a conversion price of $3.12 per share.
On
October 18, 2024, 200 shares of Series B Preferred Stock (with an aggregate stated value of $220,000) were converted by the holder into
93,299 shares of common stock at a conversion price of $2.36 per share.
On
January 15, 2025, the Company sold the Purchaser the final 250 shares of Series B Preferred Stock (the “ Final Fourth Closing
Shares ”) for $250,000 in connection with a partial and final closing of the Fourth Closing.
On
February 12, 2025, a holder of the Company’s Series B Convertible Preferred Stock converted 216 shares of Series B Convertible
Preferred Stock (with an aggregate stated value of $237,600) into 105,600 shares of common stock of the Company pursuant to the terms
of such Series B Convertible Preferred Stock, including the current conversion price of $2.25 per share.
The
Company’s stockholders at the 2024 Annual Meeting of Stockholders held on June 17, 2024 approved the issuance of more than 19.99%
of the outstanding Common Stock upon the conversion of the shares of Series B Convertible Preferred Stock and upon the exercise of warrants
in accordance with Nasdaq Listing Rule 5635(d).
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Boustead
Securities, LLC served as the Company’s financial advisor in connection with the Purchase Agreement and related transactions.
On March 17, 2025, with the approval
of the shareholders of the Company at the special meeting of shareholders held on the same date, the Company submitted to the Secretary
of the State of Texas, an amendment to the Certificate of Designations, Preferences and Rights of Series B Convertible Preferred Stock
of Mangoceuticals, Inc. (the “ Series B Designation ”), to: (a) reduce the conversion price set forth therein to a fixed
price of $1.50 per share (subject to customary adjustments for stock splits) (compared to having a fixed conversion price of $2.25 prior
to the amendment)(the “ Conversion Price ”); (b) reduce the floor price set forth therein from $2.25 to $1.50 per share
(subject to customary adjustments for stock splits)(the “ Floor Price ”); (c) remove the dividend rights set forth therein
(except for standard participatory rights for dividends declared on the Company’s common stock); and exclude the Company’s
current wholly-owned subsidiary, Mango & Peaches Corp. (“ Mango & Peaches ”), from the definition of Change of
Control Transaction thereunder (as a result, the issuance of securities of Mango & Peaches to Mr. Jacob Cohen, the Company’s
Chief Executive Officer and Chairman, will not be a Change of Control Transaction, trigger an event of default under the Series B Preferred
Stock or be deemed an Equity Condition (as defined in the designation of the Series B Preferred Stock)(the “ Designation Amendment ”).
The
Company’s Series B Convertible Preferred Stock (“ Series B Preferred Stock ”), currently have the following rights
and privileges:
Dividend
Rights . If the Company declares a dividend or makes a distribution of cash (or any other distribution treated as a dividend under
Section 301 of the Internal Revenue Code) on its shares of common stock, each holder of shares of Series B Preferred Stock shall be entitled
to participate in such dividend or distribution in an amount equal to the largest number of whole shares of common stock into which all
shares of Series B Preferred Stock held of record by such holder are convertible as of the record date for such dividend or distribution,
if any, or, if there is no specified record date, as of the date of such dividend or distribution. Notwithstanding the foregoing, holders
shall have no right of participation in connection with dividends or distributions made to stockholders of shares of common stock consisting
solely shares of common stock.
So
long as any Series B Preferred Stock remain outstanding, the Company is prohibited from effecting or entering into an agreement to effect
any issuance by the Company or any of its subsidiaries of common stock, common stock equivalents, Series B Preferred Stock or preferred
share equivalents (or a combination of units thereof) involving a Variable Rate Transaction, except for an equity line of credit. “ Variable
Rate Transaction ” means a transaction in which the Company issues or sells any debt or equity securities that are convertible
into, exchangeable or exercisable for, or include the right to receive additional shares of common stock or Series B Preferred Stock
either (A) at a conversion price, exercise price or exchange rate or other price that is based upon and/or varies with the trading prices
of or quotations for the common stock or Series B Preferred Stock at any time after the initial issuance of such debt or equity securities,
or (B) with a conversion, exercise or exchange price that is subject to being reset at some future date after the initial issuance of
such debt or equity security or upon the occurrence of specified or contingent events directly or indirectly related to the business
of the Company or the market for the common stock or Series B Preferred Stock or (ii) enters into, or effects a transaction under, any
agreement, including, but not limited to, an “at-the-market offering”, whereby the Company may issue securities at a future
determined price.
Liquidation
Preference . Upon any liquidation, dissolution or winding-up of the Company, whether voluntary or involuntary (a “ Liquidation ”),
the holders of the Series B Preferred Stock are entitled to receive out of the assets, whether capital or surplus, of the Company an
amount equal to the Stated Value, plus any accrued and unpaid dividends thereon and any other fees or liquidated damages then due and
owing, for each share of Series B Preferred Stock, before any distribution or payment shall be made to the holders of any junior securities,
and if the assets of the Company shall be insufficient to pay in full such amounts, then the entire assets to be distributed to the holders
of the Series B Preferred Stock shall be ratably distributed among the holders of the Series B Preferred Stock in accordance with the
respective amounts that would be payable on such shares if all amounts payable thereon were paid in full. A Fundamental Transaction or
Change of Control Transaction (each as described in the Series B Destination) is not deemed a Liquidation.
Conversion
Rights . Each holder of Series B Preferred Stock may, at its option, convert its shares of Series B Preferred Stock (each
a “ Series B Conversion ”) into that number of shares of common stock equal to the Stated Value of such share of Series
B Preferred Stock, divided by $1.50 (the “ Conversion Price ”).
In
the event the Company does not comply with the terms of the designation and timely issue shares of common stock upon conversion to the
holder, the Company is liable for damages in cash, as liquidated damages and not as a penalty, for each $5,000 of Stated Value of preferred
shares being converted, $50 per trading day (increasing to $100 per trading day on the fifth trading day and increasing to $200 per trading
day on the tenth trading day after such damages begin to accrue) for each trading day after the date due that the shares are delivered.
The designation also provides for customary buy-in rights to the holders for failure of the Company to timely deliver conversion shares.
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The
Series B Designation includes a conversion limitation prohibiting any holder and their affiliates from converting the Series B Preferred
Stock into common stock in the event that upon such conversion their beneficial ownership of the Company’s common stock would exceed
4.99%.
The
Conversion Price is subject to anti-dilutive rights in the event that the Company issues any shares of common stock or common stock equivalents
with a value less than the then conversion price, subject to certain customary exceptions for equity plan issuances, securities already
outstanding, and certain strategic acquisitions (the “ Anti-Dilutive Rights ”).
Additionally,
if at any time the Series B Preferred Stock are outstanding there occurs any share split, share dividend, share combination recapitalization
or other similar transaction involving the common stock (each, a “ Share Combination Event ”, and such date thereof,
the “ Share Combination Event Date ”) and the Event Market Price (defined below) is less than the then Conversion Price
then in effect, then on the sixth trading day immediately following such Share Combination Event Date, the Conversion Price then in effect
on such sixth trading day is automatically reduced (but in no event increased) to the greater of the (i) Event Market Price; and (ii)
the Conversion Price (the “ Reverse Split Reset Terms ”). The “ Event Market Price ” means, with respect
to any Share Combination Event Date, the quotient determined by dividing (x) the sum of the volume weighted average price of the common
stock for each of the five trading days ending and including the trading day immediately preceding the sixth trading day after such Share
Combination Event Date, divided by (y) five.
Voting
Rights . The Series B Preferred Stock have no voting rights, except in connection with the Protective Provisions discussed
below.
Provisions .
So long as any shares of Series B Preferred Stock are outstanding, the Company cannot without first obtaining the approval of the holders
of a majority of the then outstanding shares of Series B Preferred Stock, voting together as a class (collectively, the “ Protective
Provisions ”):
(a)
Amend any provision of the Series B Designation;
(b)
Increase or decrease (other than by redemption or conversion) the total number of authorized shares of Series B Preferred Stock;
(c)
Amend the Certificate of Formation of the Company (including by designating additional series of Preferred Stock) in a manner which adversely
affects the rights, preferences and privileges of the Series B Preferred Stock;
(d)
Effect an exchange, or create a right of exchange, cancel, or create a right to cancel, of all or any part of the shares of another class
of shares into shares of Series B Preferred Stock; or
(e)
Alter or change the rights, preferences or privileges of the shares of Series B Preferred Stock so as to affect adversely the shares
of such series.
Additionally,
so long as any Series B Preferred Stock shares remain outstanding, neither the Company nor any subsidiary thereof shall redeem, purchase
or otherwise acquire, directly or indirectly, any junior securities; pay any dividends (other than on Series B Preferred Stock), or enter
into any variable rate transaction.
Events
of Default . An “ Event of Default ” under the Series B Designation includes the occurrence of any of the events
described below:
(a)
if at any time the common stock is no longer DWAC eligible;
(b)
a registration statement of the Company is not filed within sixty (60) days of the date Series B Preferred Stock was first issued in
connection with certain shares of Series B Preferred Stock sold in 2024 and January 2025, which requirement has been met;
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(c)
the Company fails to obtain stockholder approval of the issuance of more than 20% of the Company’s outstanding common stock in
connection with the sale of certain securities within one hundred twenty (120) days of the first sale thereof (which requirement was
timely met);
(d)
the Company shall fail to deliver shares issuable upon a conversion prior to the fifth trading day after such shares are required to
be delivered;
(e)
the Company shall fail to have available a sufficient number of authorized and unreserved common stock shares to issue to any holder
upon a conversion completed under the Series B Designation;
(f)
the Company shall fail to observe or perform any other covenant, agreement or warranty contained in, or otherwise commit any breach of
any documents entered into in connection with the sale of Series B Preferred Stock, and such failure or breach shall not, if subject
to the possibility of a cure by the Company, have been cured within 10 business days after the date on which written notice of such failure
or breach shall have been delivered;
(g)
the Company shall redeem junior securities or pari passu securities;
(h)
the Company shall be party to a Change of Control Transaction (as defined in the Series B Preferred Stock designation);
(i)
the Company shall enter bankruptcy;
(j)
any monetary judgment, writ or similar final process shall be entered or filed against the Company, any subsidiary or any of their respective
property or other assets for more than $500,000 (provided that amounts covered by the Company’s insurance policies are not counted
toward this $500,000 threshold), and such judgment, writ or similar final process shall remain unvacated, unbonded or unstayed for a
period of thirty (30) trading days;
(k)
the electronic transfer by the Company of common stock shares through the Depository Trust Company is no longer available or is subject
to a “ freeze ” and/or “ chill ”, which continues for a period of five trading days; or
(l)
the common shares shall cease trading on an approved trading market, and such failure shall continue for a period of five trading days.
Following
an Event of Default, (a) the Stated Value increases automatically by an amount equal to 17.5% of the Stated Value as of the date
of the Event of Default; and (b) the conversion price of the Series B Preferred Stock is adjusted to the lesser of (i) the then applicable
conversion price and (ii) a price per share equal to sixty five percent (65%) of the average of the three lowest trading prices for the
Company’s common stock during the twenty (20) trading days preceding the relevant conversion.
Negative
Covenants : As long as any shares of Series B Preferred Stock are outstanding, unless a simple majority of holders of the Series B
Preferred Stock have otherwise given prior written consent, the Company shall not, and shall not permit any of the subsidiaries to, directly
or indirectly:
(a)
amend its charter documents, including, without limitation, its certificate of incorporation and bylaws, in any manner that materially
and adversely affects any rights of any holder;
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(b)
repay, repurchase or offer to repay, repurchase or otherwise acquire more than a de minimis number of shares of common stock, common
stock equivalents or junior securities, other than as to (i) certain pre-approved purchases agreed to by the holders of the Series B
Preferred Stock and (ii) the repurchase of common shares or common share equivalents of departing officers and directors of the Company,
provided that such repurchases shall not exceed an aggregate of $100,000 for all officers and directors for so long as the Series Preferred
Stock are outstanding;
(c)
pay cash dividends or distributions on junior securities of the Company;
(d)
enter into any transaction with any affiliate of the Company which would be required to be disclosed in any public filing with the SEC,
unless such transaction is made on an arm’s-length basis and expressly approved by a majority of the disinterested directors of
the Company (even if less than a quorum otherwise required for board approval);
(e)
redeem any junior securities or pay any dividends (other than on the Series B Preferred Stock); or
(f)
enter into any agreement with respect to any of the foregoing.
Redemption
Rights . At any time while the Series B Preferred Stock are outstanding, and on any date following stockholder approval of the issuance
of more than 20% of the Company’s common stock upon conversion of certain shares of Series B Preferred Stock certain shares of
Series B Preferred Stock sold in 2024 and January 2025 (which has occurred to date), the Company has the right to redeem fifty (50%)
of the Stated Value then outstanding, and an additional fifty (50%) percent of the Stated Value then outstanding upon the written consent
of the holders of the Series B Preferred Stock (each, the “ Company Optional Redemption Amount ”) on the Company Optional
Redemption Date (each as defined below) (a “ Company Optional Redemption ”). If redeemed within ninety (90) calendar
days from the date of issuance, the Series B Preferred Stock shares subject to redemption shall be redeemed by the Company in cash at
a price (the “ Company Optional Redemption Price ”) equal to 110% of the Stated Value being redeemed as of the Company
Optional Redemption Date, plus all accrued but unpaid dividends and all other amounts due to a holder, if any. If redeemed within ninety-one
(91) calendar days after the date of issuance, but no later than one hundred twenty (120) calendar days from the date of issuance, the
Series B Preferred Stock subject to redemption shall be redeemed by the Company in cash at a Company Optional Redemption Price equal
to 115% of the Stated Value being redeemed as of the Company Optional Redemption Date, plus all accrued but unpaid dividends and all
other amounts due to holders, if any. If redeemed after one hundred twenty (120) calendar days from the date of issuance, the Series
B Preferred Stock subject to redemption shall be redeemed by the Company in cash at a Company Optional Redemption Price equal to 120%
of the Stated Value being redeemed as of the Company Optional Redemption Date, plus all accrued but unpaid dividends and all other amounts
due to any holder, if any. The Company may deliver only one Company Optional Redemption Notice and such Company Optional Redemption Notice
shall be irrevocable.
The
Company may not deliver a Company Optional Redemption Notice, and any Company Optional Redemption Notice delivered by the Company shall
not be effective, unless all of the Equity Conditions have been met on each trading day during the period beginning on the date notice
of the redemption is provided and ending on the redemption date, which cannot be less than 10 nor more than 20 days.
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“ Equity
Conditions ” means, during the period in question: (a) the Company shall have duly honored all conversions scheduled to occur
or occurring by virtue of one or more notices of conversion of the applicable holder on or prior to the dates so requested or required,
if any; (b) the Company shall have paid all liquidated damages and other amounts owing to the applicable holder in respect of the preferred
shares; (c) (i) there is an effective registration statement or Rule 144 can be relied upon pursuant to which either: (A) the Company
may issue conversion shares [except in the case of a redemption, where only the shares being redeemed are subject to this requirement];
or (B) the holders are permitted to utilize the prospectus thereunder to resell all of the common shares issuable pursuant to certain
transaction documents (and the Company believes, in good faith, that such effectiveness will continue uninterrupted for the foreseeable
future); or (ii) all of the conversion shares issuable pursuant to the applicable transaction documents may be resold pursuant to Rule
144 without volume or manner-of-sale restrictions or current public information requirements as determined by the counsel to the Company
as set forth in a written opinion letter to such effect, addressed and acceptable to the transfer agent and the affected holders; or
(iii) all of the conversion shares may be issued to the holder pursuant to Section 3(a)(9) of the Securities Act and immediately resold
without restriction; (d) the common shares are trading on a trading market and all of the common shares issuable pursuant to the applicable
transaction documents are listed or quoted for trading on such trading market (and the Company believes, in good faith, that trading
of the common shares on a trading market will continue uninterrupted for the foreseeable future); (e) there is a sufficient number of
authorized, but unissued and otherwise unreserved, common shares for the issuance of all of the shares then issuable pursuant to the
applicable transaction documents; (f) the issuance of the common shares in question to the applicable holder would not violate the beneficial
ownership limitation set forth in the designation; (g) there has been no public announcement of a pending or proposed Fundamental Transaction
(as defined in the designation) or Change of Control Transaction (as defined in the designation) that has not been consummated; (h) the
applicable holder is not in possession of any information provided by the Company, any of its subsidiaries, or any of their officers,
directors, employees, agents or affiliates, that constitutes, or may constitute, material non-public information.
ELOC
Also
on the Initial Closing Date, the Company entered into an Equity Purchase Agreement (the “ ELOC ”) with the Purchaser
pursuant to which the Purchaser committed to purchase up to $25,000,000 (the “ Maximum Amount ”) of the Company’s
common stock (the “ Financing ”). On the Initial Closing Date, the Company issued 66,667 shares of the Company’s
common stock to the Purchaser as a commitment fee (the “ Commitment Shares ”). In connection with the Financing, on
the Closing Date, the Company and the Purchaser also entered into a Registration Rights Agreement (the “ ELOC RRA ”).
Upon
filing and effectiveness of a Registration Statement on Form S-1 to register the Advance Shares (defined below), which was declared effective
on May 9, 2024, and provided other closing conditions are met, from time to time over the term of the ELOC, the Company has the right,
but not the obligation, to direct the Purchaser to purchase shares of the Company’s common stock (the “ Advance Shares ”)
in a maximum amount of one hundred percent (100%) of the average daily trading volume over the five trading days preceding the applicable
advance date. At any time and from time to time during the 2-year term of the ELOC (the “ Commitment Period ”), the
Company may deliver a notice to Purchaser (the “ Advance Notice ”) and shall deliver the Advance Shares to Purchaser
via DWAC (as defined in the ELOC) on the next trading day. The purchase price (the “ Purchase Price ”) for the Advance
Shares shall equal 90.0% of the gross proceeds received by the Purchaser for the resale of the Advance Shares during the three consecutive
trading days immediately following the date an Advance Notice is delivered (the “ Valuation Period ”). The closing of
an Advance Notice shall occur within two trading days following the end of the respective Valuation Period, whereby the Purchaser shall
deliver the Investment Amount (as defined below) to the Company by wire transfer of immediately available funds. The Company shall not
deliver another Advance Notice to Purchaser within one trading day of a prior closing of Advance Shares. The “ Investment Amount ”
means the aggregate Purchase Price for the Advance Shares purchased by the Purchaser, minus clearing costs payable to the Purchaser’s
broker or to the Company’s transfer agent for the issuance of the Advance Shares.
The
right of the Company to issue and sell the Advance Shares to the Purchaser is subject to the satisfaction of certain closing conditions,
including, but not limited to, (i) a Registration Statement on Form S-1 registering for resale by the Purchaser of the Advance Shares
and Commitment Shares being declared effective by the SEC, which has occurred to date, (ii) accuracy of the Company’s representations
and warranties, (iii) the Company’s performance under the ELOC in all material respects, (iv) no suspension of trading or delisting
of common stock, (v) the limitation of the Purchaser’s beneficial ownership of the Company’s common stock to no more than
4.99% of the Company’s then outstanding common stock, (vi) the Company maintaining its DWAC-eligible status, (vii) the Company
maintaining a sufficient share reserve, and (viii) the closing price of the Company’s common stock on the date the Advance Notice
is received must exceed $0.15. To date, the Company has sold a total of 305,000 shares for gross proceeds of $1,185,019 before fees,
discounts and expenses under the ELOC.
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The
ELOC terminates upon the first to occur of April 4, 2026; the date that $25,000,000 in Advance Shares have been purchased by the Purchaser;
the date that the Company terminates the ELOC, which may be terminated in the Company’s option at any time following effectiveness
of the Registration Statement registering the resale of the Advance Shares, except that the ELOC can’t be terminated at any time
the Purchaser holds any Advance Shares; and upon the Company entering into bankruptcy protection (such period of time that the ELOC is
in place, the “ Commitment Period ”).
While
the Company has the obligation to maintain such share reserve while the ELOC is effective, the Company does not have the obligation to
sell any Advance Shares to the Purchaser. Additionally, neither the Purchaser, nor any affiliate of the Purchaser acting on its behalf
or pursuant to any understanding with it, will execute any short sales during the period from the date hereof to the end of the Commitment
Period.
The
Company has agreed, among other things, to indemnify the Purchaser and its affiliates with respect to certain liabilities and to pay
all fees and expenses incident to the Company’s obligations under the ELOC RRA
Additional
Private Sales of Series B Preferred Stock and Common Stock
Effective
on December 18, 19, and 31, 2024 and January 3, 6 and 6, 2025, we agreed to definitive terms on Securities Purchase Agreements (the “ SPAs ”),
with certain institutional accredited investors (the “ Purchasers ”), pursuant to which the Company sold the Purchasers,
and the Purchasers purchased from the Company, 250 shares of Series B Preferred Stock for $250,000, and warrants to purchase 330,000
shares of common stock with an exercise price of $2.71 per share, 100 shares of Series B Preferred Stock for $100,000, and warrants to
purchase 132,000 shares of common stock with an exercise price of $2.57 per share, 50 shares of Series B Preferred Stock for $50,000,
and warrants to purchase 60,000 shares of common stock, with an exercise price of $2.57 per share; 300 shares of Series B Preferred Stock
for $300,000, and warrants to purchase 396,000 shares of common stock with an exercise price of $2.61 per share; 500 shares of Series
B Preferred Stock for $500,000, and warrants to purchase 660,000 shares of common stock with an exercise price of $2.59 per share; and
50 shares of Series B Preferred Stock for $50,000, and warrants to purchase 66,000 shares of common stock with an exercise price of $2.59
per share, respectively. Each of the SPAs closed on the dates they were entered into, and the warrants were granted on the same dates.
The
SPAs provide that until the 18 th month anniversary of the applicable closing date, the Purchasers have the right to participate
in any issuance by the Company or any of its subsidiaries of common stock or common stock equivalents or any offering of debt or any
other type of financing, or a combination thereof (other certain customary exempt issuances)(each a “ Subsequent Financing ”),
in an amount not to exceed the amount of the Purchaser’s subscription, on the same terms, conditions and price provided for in
the Subsequent Financing.
The
SPAs contain customary representations, warranties and covenants by the Company (including a restriction on entering into any variable
rate transaction for a period of 180 days from the applicable closing date), customary conditions to closing, indemnification obligations
of the Company and the Purchasers, other obligations of the parties and termination provisions.
If
at any time following the Initial Exercise Date (as defined below) of the warrants, there is no effective registration statement registering,
or the prospectus contained therein is not available for the shares of common stock issuable upon exercise of the warrants, the warrants
can be exercised on a cashless basis as described in greater detail in the Common Share Purchase Warrants entered into to evidence the
warrants (the “ Warrant Agreements ”). The warrants are exercisable on or after 180 days from their grant date (“ Initial
Exercise Date ”), and for five years thereafter.
The
warrants contain provisions that prohibit exercise if the holder thereof, together with its affiliates, would beneficially own in excess
of 4.99% of the number of the Company’s shares of common stock outstanding immediately after giving effect to such exercise. A
holder of the warrants may increase or decrease this percentage, but not in excess of 9.99%, by providing at least 61 days’ prior
notice to the Company. In the event of certain corporate transactions, a holder of the Warrants will be entitled to receive, upon exercise
of the warrants, the kind and amount of securities, cash or other property that the holder would have received had it exercised the warrants
immediately prior to such transaction.
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If
the Company or any subsidiary at any time while the warrants are outstanding, shall sell, enter into an agreement to sell or grant any
option to purchase, or sell or grant any right to reprice, or otherwise dispose of or issue (or announce any offer, sale, grant or any
option to purchase or other disposition) any common stock or common stock equivalents, at an effective price per share less than the
exercise price of the warrants then in effect (such lower price, the “ Base Share Price ” and such issuances collectively,
a “ Dilutive Issuance ”) then simultaneously with the consummation (or, if earlier, the announcement) of each Dilutive
Issuance the exercise price shall be reduced and only reduced to equal the Base Share Price. No adjustment however is to be made for
certain customary Exempt Issuances (as defined in the SPAs).
The
warrants also include customary buy-in rights in the event the Company fails to timely deliver the shares of common stock issuable upon
exercise thereof.
If
at any time the warrants are outstanding there occurs any share split, share dividend, share combination recapitalization or other similar
transaction involving the common stock (each, a “ Share Combination Event ”, and such date thereof, the “ Share
Combination Event Date ”) and the Event Market Price (defined below) is less than the then exercise price then in effect, then
on the sixth trading day immediately following such Share Combination Event Date, the exercise price then in effect on such sixth trading
day is automatically reduced (but in no event increased) to the Event Market Price. The “ Event Market Price ” means,
with respect to any Share Combination Event Date, the quotient determined by dividing (x) the sum of the volume weighted average price
of the common stock for each of the five trading days ending and including the trading day immediately preceding the sixth trading day
after such Share Combination Event Date, divided by (y) five.
As
a result of a dilutive issuance, the exercise price of the warrants was automatically reduced to $1.50 per share.
On
February 3, 2025, the Company entered into a Subscription Agreement with an accredited investor and sold 70,000 shares of the Company’s
restricted common stock for a total of $105,000, $1.50 per share. The Subscription Agreement included customary representations and warranties
of the purchaser and the Company.
On
February 7, 2025, the Company entered into a Subscription Agreement with an accredited investor and sold 155,555 shares of the Company’s
restricted common stock for a total of $350,000 (or $2.25 per share). The Subscription Agreement included customary representations and
warranties of the purchaser and the Company.
Need
for Future Funding
As
discussed above, our current capital resources are not expected to be sufficient for us to fund operations for the next 12 months. We
believe we will need to raise additional funding to support our operations in the future. We may also seek to acquire additional businesses
or assets in the future, which may require us to raise funding. We currently anticipate such funding, if required, being raised through
the offering of debt or equity, and/or through additional sales under the ELOC. Such additional financing, if required, may not be available
on favorable terms, if at all. If debt financing is available and obtained, our interest expense may increase and we may be subject to
the risk of default, depending on the terms of such financing. If equity financing is available and obtained it may result in our shareholders
experiencing significant dilution. If such financing is unavailable, we may be forced to curtail our business plan, which may cause the
value of our securities to decline in value.
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Critical
Accounting Policies and Estimates
The
preparation of the Company’s consolidated financial statements in accordance with accounting principles generally accepted in the United States
of America (“ GAAP ”) requires management to make estimates and assumptions that affect the reported amounts of assets,
liabilities and expenses. “ Note 2 – Summary of Significant Accounting Policies ” to the audited consolidated financial statements
included under “ Item 8. Financial Statements and Supplementary Data, ” below describes the significant accounting policies
used in the preparation of the financial statements. Certain of these significant accounting policies and estimates have a higher degree
of inherent uncertainty and require significant judgments. Accordingly, actual results could differ from those estimates. To the extent
that there are differences between our estimates and actual results, our future financial statement presentation, financial condition,
results of operations and cash flows will be affected.
A
critical accounting policy is defined as one that is both material to the presentation of our financial statements and requires management
to make difficult, subjective or complex judgments that could have a material effect on our financial condition and results of operations.
Specifically, critical accounting estimates have the following attributes: (1) we are required to make assumptions about matters that
are highly uncertain at the time of the estimate; and (2) different estimates we could reasonably have used, or changes in the estimate
that are reasonably likely to occur, would have a material effect on our financial condition or results of operations.
Estimates
and assumptions about future events and their effects cannot be determined with certainty. We base our estimates on historical experience
and on various other assumptions believed to be applicable and reasonable under the circumstances. These estimates may change as new
events occur, as additional information is obtained and as our operating environment changes. These changes have historically been minor
and have been included in the financial statements as soon as they became known. Based on a critical assessment of our accounting policies
and the underlying judgments and uncertainties affecting the application of those policies, management believes that our consolidated financial statements
are fairly stated in accordance with GAAP and present a meaningful presentation of our financial condition and results of operations.
We believe the following critical accounting policies reflect our more significant estimates and assumptions used in the preparation
of our consolidated financial statements:
Share-Based
Compensation – Stock-based compensation is accounted for based on the requirements of the Share-Based Payment Topic of
Financial Accounting Standards Board (“ FASB ”) Accounting Standards Codification (“ ASC ”) 718, which
requires recognition in the consolidated financial statements of the cost of employee and director services received in exchange for
an award of equity instruments over the shorter of period the employee or director is required to perform the services in exchange for
the award or the vesting period. ASC 718 also requires measurement of the cost of employee and director services received in exchange
for an award based on the grant-date fair value of the award. Pursuant to ASC 505-50, for share-based payments
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