Mangoceuticals, Inc. (NASDAQ: MGRX) (“MangoRx” or the “Company”), a
leader in men’s health and wellness products including erectile
dysfunction (ED), hair growth, weight loss, and hormone replacement
therapies, is excited to announce the initiation of efficacy
studies on its patented respiratory illness prevention technology
in collaboration with Vipragen Biosciences and IntraMont
Technologies, Inc. Notably, these trials have been pre-funded,
ensuring that the Company does not need to raise any additional
capital for the completion of these studies, which are anticipated
to be concluded in the earlier part of the 3rd quarter.
The recently acquired patented technology by
MangoRx is designed to reduce the incidence of respiratory
illnesses, including, but not limited to, H1N1 variants, Avian Flu,
the common cold, Coronavirus and others. The studies are set to
commence within the next few weeks with results anticipated to be
concluded in the earlier part of the 3rd quarter. These include
animal studies to quantify the prophylactic performance of the
technology against select viruses and viral strains. The
composition being tested contains a very select tannin (an enhanced
polyphenol) and zinc gluconate as its primary active
ingredients.
Jacob Cohen, Co-Founder and CEO of MangoRx
stated, "Our global patent portfolio enables us to make a
meaningful impact on global health. The initiation of these studies
is a crucial step in demonstrating the efficacy of our innovative
technology. We anticipate that our solution will play a vital role
in managing respiratory illness outbreaks."
The studies will be conducted by Vipragen
Biosciences, an AAALAC-accredited preclinical CRO located in
Mysuru, India, in collaboration with IntraMont Technologies, Inc.
The specific studies include an efficacy study of an anti-viral
oral spray in treating influenza infection in mice. This study will
evaluate the therapeutic potential and effectiveness of the
anti-viral oral spray in combating influenza infections in a
controlled mouse model, aiming to provide critical data on the
spray's ability to reduce viral load, alleviate symptoms, and
improve survival rates in treated subjects. Additionally, the
evaluation of antiviral efficacy will be conducted using the ASTM
E1052 standard test method assay, which rigorously assesses the
antiviral efficacy of the technology, measuring the ability of the
antiviral agents to inactivate specific viruses and providing
essential insights into their potential for broader antiviral
applications.
James Intrator, CEO of Intramont Technologies,
Inc. and one of the original inventors of the intellectual property
and technology commented, “the primary focus will be on testing the
durability of the prophylactic coating towards viral infections.
Polyphenolic nasal sprays have been successfully used to block
select respiratory viruses, and the company is enhancing this
approach by transitioning the concept of nasal spray to an
oral-only application for better distribution and user compliance.
The technology features biosafe ingredients that readily bind to
protein spikes on the surface of virions (virus particles).
Additionally, polyphenols bind to the oral and oropharyngeal
membranes, acting as a tissue barrier.”
Previous research has highlighted the potential
of this technology. In studies conducted by Moscow State University
in late 2020 and early 2021, researchers used cell cultures with a
pseudo virus simulant of SARS-CoV-2, combining a specific
commercial tannin with zinc gluconate. The results demonstrated a
significant reduction in active virus, showing a 93% (±5%) decrease
compared to the control group (Tsvetkov et al., 2021).
Before someone can develop certain respiratory
infections, the virus must first infect the mouth or back of the
throat (surface of the pharynx) and incubate. Various research
groups, including Columbia University (de Vries et al., 2021),
Cornell (Shapira et al., 2022), and Berkeley (Zhu et al., 2022),
have demonstrated success in preventing respiratory infections
through the application of daily-use nasal sprays. These sprays
have shown effectiveness even up to 12 hours after initial exposure
to the virus. In some published results, the principal active
ingredient of the nasal spray was a polyphenol.
Importantly, zinc in nasal applications can
cause anosmia due to Zn+2 damage to the olfactory epithelium nerves
(Alexander & Davidson, 2006). This can cause some people to
lose their sense of smell, in some cases permanently. This led the
FDA to prohibit the use of zinc salts directly in the nasal
passages. However, there are no reported problems from zinc in oral
applications, such as lozenges, mouthwashes, or toothpastes, where
zinc salts retain a distinct presence even after repeated rinsing
(Gilbert et al., 1989). This makes the oral application of this
technology particularly safe and effective. The technology uses
zinc gluconate in its formulation to ensure safety and efficacy in
preventing respiratory infections.
MangoRx’s patent portfolio for this innovative
technology is globally recognized, enabling the company to address
respiratory health concerns worldwide. The Company anticipates that
the product will initially be available as a lozenge or a
toothpaste providing a convenient and effective means of preventing
the onset and spread of respiratory illnesses. The global influenza
market alone was valued at $8.28 billion in 2023, highlighting the
significant potential for this technology in addressing respiratory
health (Market Data Forecast, 2023).
Should the current trials yield positive
results, MangoRx will promptly initiate a subsequent study specific
to the H5N1 strain. This study will aim to evaluate the
technology's potential in addressing avian influenza, a pressing
concern for poultry farms across the US. This follow-up study is
particularly relevant given the recent rise in avian flu outbreaks,
emphasizing the potential broader applications of this innovative
prophylactic technology.
With respiratory infections posing an increasing
threat, MangoRx is actively exploring the potential of its patented
technology to mitigate the impact of this global health
concern.
About MangoRx
MangoRx is focused on developing a variety of
men's health and wellness products and services via a secure
telemedicine platform. To date, the Company has identified men's
wellness telemedicine services and products as a growing sector and
especially related to the area of erectile dysfunction (ED), hair
growth and hormone replacement therapies. Interested consumers can
use MangoRx’s telemedicine platform for a smooth experience.
Prescription requests will be reviewed by a physician and, if
approved, fulfilled and discreetly shipped through MangoRx’s
partner compounding pharmacy and right to the patient’s doorstep.
To learn more about MangoRx’s mission and other products, please
visit www.MangoRx.com or on social media @Mango.Rx.
Cautionary Note Regarding
Forward-Looking Statements
Certain statements made in this press release
contain forward-looking information within the meaning of
applicable securities laws, including within the meaning of the
Private Securities Litigation Reform Act of 1995 (“forward-looking
statements”). These forward-looking statements represent the
Company’s current expectations or beliefs concerning future events
and can generally be identified using statements that include words
such as “estimate,” “expects,” “project,” “believe,” “anticipate,”
“intend,” “plan,” “foresee,” “forecast,” “likely,” “will,” “target”
or similar words or phrases. These forward-looking statements are
subject to risks, uncertainties and other factors, many of which
are outside of the Company’s control which could cause actual
results to differ materially from the results expressed or implied
in the forward-looking statements, our ability to meet Nasdaq’s
minimum bid price requirement and other continued listing
requirements of Nasdaq; the Company’s stockholders’ equity as of
the Company’s next fiscal quarter end, which is required to be
above $2.5 million pursuant to correspondence from Nasdaq; our
ability to maintain the listing of our common stock on Nasdaq; our
ability to commercialize our patent portfolio; our ability to
obtain Comisión Federal para la Protección contra Riesgos
Sanitarios for our ED product in Mexico, the costs thereof and
timing associated therewith; our ability to obtain additional
funding and generate revenues to support our operations; risks
associated with our ED product which have not been, and will not
be, approved by the U.S. Food and Drug Administration (“FDA”) and
have 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
Federal Food, Drug, and Cosmetic Act (“FFDCA Act”) provided by
Section 503A; risks associated with 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 significant reliance on related party transactions;
the projected size of the potential market for our technologies and
products; risks related to the fact that our Chairman and Chief
Executive Officer, Jacob D. Cohen has significant voting control
over the Company; risks related to the significant number of shares
in the public float, our share volume, the effect of sales of a
significant number of shares in the marketplace, and the fact that
the majority of our shareholders paid less for their shares than
the public offering price of our common stock in our recent initial
public offering; dilution caused by recent offerings; conversion of
outstanding shares of preferred stock and the rights and
preferences thereof, the fact that we have a significant number of
outstanding warrants to purchase shares of common stock and other
convertible securities, the resale of which underlying shares have
been registered under the Securities Act of 1933, as amended,
dilution caused by exercises/conversions thereof, overhang related
thereto, and decreases in the trading price of our common stock
caused by sales thereof; our ability to build and maintain our
brand; cybersecurity, information systems and fraud risks and
problems with our websites; changes in, and our compliance with,
rules and regulations affecting our operations, sales, marketing
and/or our products; shipping, production or manufacturing delays;
regulations we are required to comply with in connection with our
operations, manufacturing, labeling and shipping; our dependency on
third-parties to prescribe and compound our ED product; 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 rates of inflation
and 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 war in Israel) and other large-scale
crises; our ability to protect intellectual property rights; our
ability to attract and retain key personnel to manage our business
effectively; overhang which may reduce the value of our common
stock; volatility in the trading price of our common stock; and
general consumer sentiment and economic conditions that may affect
levels of discretionary customer purchases of the Company’s
products, including potential recessions and global economic
slowdowns. Although we believe that our plans, intentions and
expectations reflected in or suggested by the forward-looking
statements we make in this release are reasonable, we provide no
assurance that these plans, intentions or expectations will be
achieved. Consequently, you should not consider any such list to be
a complete set of all potential risks and uncertainties.
More information on potential factors that could
affect the Company’s financial results is included from time to
time in the “Cautionary Note Regarding Forward-Looking Statements,”
“Risk Factors” and “Management’s Discussion and Analysis of
Financial Condition and Results of Operations” sections of the
Company’s filings with the SEC, including the Company’s Annual
Report on Form 10-K for the year ended December 31, 2023 and our
Quarterly Report on Form 10-Q for the three months ended March 31,
2024, and subsequent reports. These filings are available
at www.sec.gov and at our website
at https://www.mangoceuticals.com/sec-filings. All subsequent
written and oral forward-looking statements attributable to the
Company or any person acting on behalf of the Company are expressly
qualified in their entirety by the cautionary statements referenced
above. Other unknown or unpredictable factors also could have
material adverse effects on the Company’s future results. The
forward-looking statements included in this press release are made
only as of the date hereof. The Company cannot guarantee future
results, levels of activity, performance or achievements.
Accordingly, you should not place undue reliance on these
forward-looking statements. Finally, the Company undertakes no
obligation to update these statements after the date of this
release, except as required by law, and takes no obligation to
update or correct information prepared by third parties that are
not paid for by the Company. If we update one or more
forward-looking statements, no inference should be drawn that we
will make additional updates with respect to those or other
forward-looking statements.
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