U.S.
SECURITIES AND EXCHANGE COMMISSION
Washington,
D.C. 20549
AMENDMENT NO. 1 TO
FORM
10
GENERAL
FORM FOR REGISTRATION OF SECURITIES
PURSUANT
TO SECTION 12(b) OR 12(g) OF THE SECURITIES EXCHANGE ACT OF 1934
REDWOOD
SCIENTIFIC TECHNOLOGIES, INC.
(Exact
name of registrant as specified in charter)
Delaware | 47-3165559 | |
(State or other jurisdiction of incorporation or registration) |
(I.R.S. Employer Identification No.) |
|
418 Broadway, STE 4872, Albany, NY |
12207 | |
(Address of principal executive offices) |
(Zip Code) |
|
(310) 693-5401 |
||
(Registrant’s telephone number, including area code) |
with
copies to:
David
E. Danovitch, Esq.
Joseph
E. Segilia, Esq.
Sullivan
& Worcester LLP
1633
Broadway
New
York, NY 10019
(212)
660-3000
Securities
to be registered pursuant to Section 12(b) of the Act:
None
Securities
to be registered pursuant to Section 12(g) of the Act:
(Title
of class)
Common
stock, par value $0.001 per share
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 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. ☐
TABLE
OF CONTENTS
EXPLANATORY
NOTE
Redwood
Scientific Technologies, Inc. is filing this General Form for Registration of Securities on Form 10, (this “Form 10”
or the “Registration Statement”), to register its share of common stock, par value $0.001 per share (the “Common
Stock’), pursuant to Section 12(g) of the Securities Exchange Act of 1934, as amended (the “Exchange Act”).
Once
this registration statement is deemed effective, we will be subject to the requirements of Regulation 13A under the Exchange
Act, which will require us to file annual reports on Form 10-K, quarterly reports on Form 10-Q, and current reports on Form 8-K.
We will be required to comply with all other obligations of the Exchange Act applicable to issuers filing registration
statements pursuant to Section 12(g) of the Exchange Act.
Unless
otherwise mentioned or unless the context requires otherwise, when used in this Registration Statement, the terms
“Redwood,” “RST,” “Company,” “we,” “us,” and “our” refer to
Redwood Scientific, Inc. and its subsidiaries.
FORWARD-LOOKING
STATEMENTS
This
Registration Statement contains forward-looking statements that involve substantial known and unknown risks, uncertainties and
other factors. Undue reliance should not be placed on such statements. These forward-looking statements are not historical facts,
but rather are based on current expectations, estimates and projections about our company, our current and prospective portfolio
investments, our industry, our beliefs and our assumptions. Words such as “anticipates,” “expects,” “intends,”
“plans,” “will,” “may,” “continue,” “believes,” “seeks,”
“estimates,” “would,” “could,” “should,” “targets,” “projects,”
and variations of these words and similar expressions are intended to identify forward-looking statements.
Forward-looking
statements include, but are not limited to, statements about:
● | the ability of our clinical trials to demonstrate safety and efficacy of our product candidates, and other positive results; |
● | the timing of commencement and focus of our clinical trials, and the reporting of data from those trials; |
● | the size of the market opportunity for our product candidates; developments and projections relating to our competitors and our industry and the success of competing products that are or may become available; |
● | the beneficial characteristics, safety, efficacy and therapeutic effects of our product candidates; |
● | our ability to obtain and maintain regulatory approval of our product candidates; |
● | existing regulations and regulatory developments in the United States and other jurisdictions; |
● | our plans and ability to obtain or protect intellectual property rights and our ability to avoid infringing the intellectual property rights of others; |
● | our ability to effectively manage our growth, including the need to hire additional personnel and our ability to attract, recruit and retain such personnel, and maintain our culture; |
● | our estimates regarding expenses, future revenue, capital requirements and needs for additional financing; the performance of our third-party suppliers and manufacturers; |
● | our financial performance; and |
● | the period over which we estimate our existing cash will be sufficient to fund our future operating expenses and capital expenditure requirements. |
We
have based these forward-looking statements largely on our current expectations and projections about our business, the industry
in which we operate and financial trends that we believe may affect our business, financial condition, results of operations and
prospects, and these forward-looking statements are not guarantees of future performance or development. These forward-looking
statements speak only as of the date of this Form 10 and are subject to a number of risks, uncertainties and assumptions described
in the section titled “Risk Factors” and elsewhere in this Form 10. Because forward-looking statements are inherently
subject to risks and uncertainties, some of which cannot be predicted or quantified, you should not rely on these forward-looking
statements as predictions of future events. The events and circumstances reflected in our forward-looking statements may not be
achieved or occur and actual results could differ materially from those projected in the forward-looking statements. Except as
required by applicable law, we do not plan to publicly update or revise any forward-looking statements contained herein, whether
as a result of any new information, future events or otherwise.
Although
we believe that the expectations reflected in the forward-looking statements are reasonable, we cannot guarantee future results,
levels of activity, performance, or achievements. Except as required by law, we are under no duty to update or revise any of the
forward-looking statements, whether as a result of new information, future events or otherwise, after the date of this Registration
Statement.
WHERE
YOU CAN FIND MORE INFORMATION
Electronic
copies of the materials we file with the Securities and Exchange Commission (the “SEC”) will be available to the public
at the web site maintained by the SEC at http://www.sec.gov.
General
We
are a pharmaceutical company committed to the global development and commercialization of homeopathic drugs and supplements for smoking
and vaping cessation. We intend to manufacture and market sublingually delivered over the counter (“OTC”) supplements that
address unmet needs in a multi-billion-dollar market for nicotine cessation.
We
are currently preparing to start conducting clinical trials to assess safety and efficacy of TBX-FREE in smoking cessation and
TBX-VAPE-FREE in vaping cessation. Provided our clinical trials are successful, we believe our products can help many people curb
their addiction to nicotine. Our products will be centered on the innovative sublingual strip technology we have developed. We
do not depend on any licenses for our products.
Our
Products
We
currently have a smoking cessation product listed with the Food and Drug Administration (the “FDA”) and after development
we intend to list a vaping cessation product with the FDA. We have a successful history in nicotine replacement therapy with our
FDA listed product, TBX-FREE, which we believe is among the first FDA listed oral strip that helps smokers eliminate the craving
to smoke. In addition to treating smoking addiction, we are also focused on vaping cessation. We are in the process of developing
and launching a new product, TBX-VAPE-FREE, to assist individuals to quit vaping, which we believe will be among the world’s
first-to-market product for the addiction of nicotine in a vape device. Both of our products utilize patent-pending, sublingual
strip delivery technology.
We believe TBX-FREE is one of the first
FDA-listed oral strips that helps with smoking cessation. We believe TBX-FREE has the ability to help reduce smoking cravings.
As a result, smokers may enjoy the freedom to live their lives without the powerful urge to light up cigarettes, cigars, and other
tobacco or consume other nicotine products.
Every TBX-FREE oral strip contains
a precisely measured dose of cytisine; the active ingredient that reduces the urge to smoke. A report, published by Elsevier Inc.
on July 28, 2022, studied the effects of cystine on smoking cessation. From July 2019 to March 2020, the Screening and Multiple
Intervention on Lung Epidemics RCT enrolled 869 current heavy tobacco users in a screening program, with a randomized comparison
of pharmacologic intervention with cytisine plus counseling (N = 470) versus counseling alone (N = 399). The primary outcome was
continuous smoking abstinence at 12 months, biochemically verified through carbon monoxide measurement. At the 12-month follow-up,
the quit rate was 32.1% (151 participants) in the intervention arm and 7.3% (29 participants) in the control arm.
Thin-film drug delivery has emerged
as an innovative alternative to the traditional pill form associated with prescription and OTC medication. Similar in size, shape
and thickness to a postage stamp, thin-film strips are typically designed for oral administration, with the user placing the strip
on or under the tongue. These drug delivery options allow the medication to bypass the first pass metabolism thereby making the
medication more bioavailable. As the strip dissolves, the drug can enter the blood stream enterically, buccally or sublingually.
Evaluating the systemic transmucosal drug delivery, the buccal mucosa is the preferred region as compared to the sublingual mucosa.
The sublingual and buccal delivery of a drug via this film product has the potential to improve the onset of action and lower
the dosing of the medicament compared to alternative means of delivery of a drug. We believe other benefits of the sublingual
delivery mechanism are:
● | All tablet dosage forms, soft gels and liquid formulations primarily enter the blood stream via the gastrointestinal tract, which subjects the drug to degradation from stomach acid, bile, digestive enzymes and other first-pass effects. As a result, such formulations often require higher doses and generally have a delayed onset of action/reaction. |
● | Conversely, buccal and sublingual thin-film drug delivery mechanisms can avoid these issues and yield quicker onsets of action/reaction at lower doses. This is regulated by the FDA per Code of Federal Regulations under Title 21 “Food and Drugs” §330 (4-14-14 Edition). |
● | Thin-film used in the sublingual delivery mechanism is more stable, durable and quicker dissolving than other conventional dosage forms. |
● | Thin-film used in the sublingual delivery mechanism enables improved dosing accuracy relative to liquid formulations since every strip is manufactured to contain a precise amount of the drug. |
● | Thin-film’s ability to dissolve rapidly without the need for water provides an alternative to patients with swallowing disorders and to patients suffering from nausea, such as those patients receiving chemotherapy. |
● | Sublingual film delivers a convenient, quick-dissolving therapeutic dose contained within an abuse-deterrent film matrix that cannot be crushed or injected by patients, and rapidly absorbs under the tongue to ensure compliance. |
● | Sublingual film also allows up to 99% absorption rate compared to normal oral tablets that may have as low as a 5% absorption rate. |
Clinical Trials
We are currently preparing to start
conducting clinical trials to assess safety and efficacy of TBX-FREE in smoking cessation and TBX-VAPE-FREE in vaping cessation.
We believe that TBX-FREE and TBX-VAPE-FREE make compelling product candidates to further evaluate in clinical trials for the treatment
of nicotine cessation. Respective clinical trials will be conducted simultaneously in a course of approximately four months. We
expect the approximate cost is $1.25 million. After, we will continue following the individuals in the clinical trials for an
additional approximately eight months to reevaluate for long term results. We have not yet submitted an Investigational New Drug
(IND) Application to the FDA in connection with the clinical trials.
We are currently building and developing
our own clinical trial virtual portal named “Clinical Safe.” Our Clinical Safe software will allow for accuracy and
consistency of clinical study work and effectiveness studies of our products. Clinical Safe will be built to ensure that all of
the physicians and the nursing staff are consistent in question and input data to log a new test subject while on the back end
the test subject is also able to log in and respond to the data inputs. Clinical Safe is designed to create an easy-to-use capture
and report system for the user. We believe Clinical Safe will allow for accurate reporting and increase volume of size in study
groups. The name of this portal, Clinical Safe, is not meant to imply that the FDA has determined that our products are safe
or effective for medical use, as this portal is still being developed and has not yet been discussed with the FDA. We intend to
introduce Clinical Safe to the FDA once its development is concluded.
In addition to the clinical trials,
we have begun the first stages of building out an effectiveness study for both our products TBX FREE and TBX VAPE FREE. The study
will be a double-blind randomized placebos study of both males and females that are addicted to nicotine. The study will look
at the effectiveness to stop the addiction to nicotine in both a combustible cigarette and a vape based delivery of nicotine. The
effectiveness study is supplemental to clinical trials and focuses only on efficacy of our products in smoking and vaping cessation.
We have retained an FDA counsel who
work directly with the FDA to ensure the Company’s compliance with federal and state regulatory authorities. The FDA counsel
helps with the evaluation and development process for new products and shepherds the products through the regulatory process.
The process taken is determined and dependent on how the products are to be marketed and their intended effects. Each FDA regulatory
category brings with it certain benefits (regarding, for instance, the claims that can be made related to the product) and challenges
(regarding, for instance, pre-marketing clearance requirements).
The Global Nicotine Replacement
Therapy Market
According to a study conducted by Grand
View Research, Inc., the global nicotine replacement therapy (“NRT”) market size
was valued at $51.2 billion in 2021 and is expected to expand at a compound annual growth rate (“CAGR”) of
16.3% from 2021 to 2028 in the U.S., Canada, U.K., Germany, France, Spain, Italy, China, Japan, Australia, South Korea, Brazil,
Mexico, South Africa, Saudi Arabia and UAE combined. The NRT markets represent significant opportunities for us. Once our
clinical trials conclude, we plan to expand both domestically and into international markets such as Europe, United Kingdom, Central
America and South America for our products. Expanding sales of our products into other countries typically requires approval of
regulatory agencies in those countries, and to date we have not taken any steps to obtain such approvals.
The global e-cigarette and vape
market size is expected to reach $182.84 billion by 2030, registering CAGR of 30.6% from 2023 to 2030, according to the aforementioned
study by Grand View Research, Inc. Since people of all ages have become more concerned about traditional cigarettes, the desire
for substantially less hazardous e-cigarettes and vape goods has grown. E-cigarettes and e-liquid products are available in various
flavors and types, and advances in e-cigarette technology have enabled users to choose their device and flavor of interest, helping
the industry expand. Increased awareness of healthier alternatives to tobacco use has prompted the global uptake of e-cigarettes. The
Company did not commission the study conducted by Grand View Research, Inc.
The
Center for Disease Control and prevention (the “CDC”) has stated that a study released on October 7, 2022
from the FDA and the CDC found that 2.55 million U.S. middle and high school students reported current (past 30-day) e-cigarette
use in 2022, which includes 14.1% of high school students and 3.3% of middle school students. Nearly 85% of those youth used flavored
e-cigarettes and more than half used disposable e-cigarettes. The findings, published in the Morbidity and Mortality Weekly
Report, are based on data from the 2022 National Youth Tobacco Survey (NYTS), a cross-sectional, self-administered survey of U.S.
middle (grades 6–8) and high (grades 9–12) school students, which was administered January 18–May 31, 2022.
The study assessed current use (on one or more of the past 30 days) of e-cigarettes; frequency; and use by device type, flavors,
and usual brand.
Our
History
The Company was originally organized
in 1986 as Prescription Corporation of America and it later changed its name to Greenway Design Group, Inc. On December 14, 2017,
Redwood Scientific Technologies, Inc., a Nevada corporation, reverse merged into the Company. On January 5, 2018 the Company changed
its name to Redwood Scientific Technologies, Inc. From March 2018 to November 2022, the Company was dormant as a result of a receivership
imposed during legal proceedings in Federal Trade Commission v. Redwood Scientific Technologies, Inc., et. al. (No. 5:18-cv-02104).
At the time, Redwood was engaged in the sale of health supplement products including tobacco cessation, weight loss, and other
over-the-counter products. Injunctive relief was obtained, and a receiver was appointed for Redwood. The receiver did not continue
to operate Redwood during the pendency of the case, which concluded on March 1, 2022, with entry of a Final Judgment and Final
Injunction. No action was taken to renew Redwood operations until November 2022. The Company has decided to focus on manufacturing
smoking cessation products and would not restart operations on other products previously manufactured by the Company.
Business
Model
Our
primary business strategy is to become a leading therapy for nicotine cessation through the development and commercialization
of TBX-FREE and TBX-VAPE-FREE. We are fully engaged in serving and providing our customers with the highest quality product. The
Company has as its core value the importance of health and wellness in the lives of every human being and our core belief is that
we can play a big role in assisting our customers in addressing their health and wellness concerns.
The target market for TBX-FREE and
TBX-VAPE-FREE are wholesale vendors and distributors, including online stores. We do not sell or market our products direct to
consumers. Our distributors will be located primarily in the United States, but we are also in discussions with distributors and
wholesalers selling in the European Union and in the United Kingdom.
We target for 80% gross profit margin
on our products. Our products will be priced using the value-based valuation system, where the customers know they are receiving
a quality product for a premium price.
We work only with distributors and
wholesale vendors selling to retail stores. Retail sales is to include the three main categories of retail: grocery, convenient
stores and drug stores. All of the categories listed will break down into subcategories of regional chain, national chain and
single point locations. We will also focus on sales that are delivered to consumers through non-brick and mortar channels. We
will not sell to end users through these online channels, but we plan to develop distribution relationships with sellers that
sell into these channels and buy products from us at wholesale pricing. These channels for sales would include walmart.com, Amazon,
eBay, and Google stores to name a few we are having discussions with.
Market
Analysis
As previously mentioned, the global nicotine
replacement therapy market size was valued at $51.2 billion in 2021 and is expected to expand at a CAGR of 16.3% from 2021 to 2028
in the U.S., Canada, U.K., Germany, France, Spain, Italy, China, Japan, Australia, South Korea, Brazil, Mexico, South Africa, Saudi
Arabia and UAE combined. The growth can be attributed to the growing number of technological advancements and the increasing number
of people undergoing NRT. Increasing awareness about the ill-effects of smoking is expected to be a key factor driving the market.
The number of people who smoke is rising globally and has surpassed 1.1 billion. Owing to government initiatives such as the Affordable
Care Act, insurance regulations, and programs for awareness regarding the negative impact of smoking on health by provision of
counseling, people are opting for smoking cessation therapies. In 2018, out of the 34.2 million people that smoke in America, 55%
tried smoking cessation.
May 31st is celebrated as
No Tobacco Day and organizations such as the American Lung Association and the CDC work toward increasing awareness about the
medical conditions that arise due to smoking. According to the U.S. Department of Health and Human Services, smoking contributes
to 80 percent and 90 percent of lung cancer deaths in women and men, respectively, and men who smoke are 23 times more likely
to develop lung cancer, while women are 13 times more likely, compared to never smokers. Furthermore, smokers are more prone to
getting heart attacks. Between 2005 and 2010, an average of 130,659 Americans (74,300 men and 56,359 women) died of smoking-attributable
lung cancer each year. The CDC runs a paid national campaign called Tips From Former Smokers (Tips) to encourage healthcare providers
to tell patients about the effects of smoking and support them in quitting smoking in safe ways.
Technological advancements in the nicotine replacement therapy segment are ongoing, which has led to a
rise in the number of people switching to advanced products. Advancements like heat-not-burn products,’ flavored chewing
gums, and lozenges are expected to drive the adoption of NRT. The tobacco giants, like British American Tobacco, have
come up with alternatives that are smokeless and less harmful. These advancements have a variable range of effectiveness and are
accepted in society when compared to traditional cigarettes, thus driving their adoption and boosting the market growth.
However, the ban on e-cigarettes is one of the most crucial factors hindering the growth of the market.
For instance, in September 2019, the Indian government banned the import, production, and sale of e-cigarettes. India is a nation
with over 100 million smokers, and this could have been a great opportunity for market growth. In addition, other nations such
as Mexico, Brazil, Cambodia, and Thailand have banned the use, import, and production of e-cigarettes in their countries. According
to the World Health Organization, there are currently over 30 nations that have banned the use of e-cigarettes. This is expected
to have a negative impact on the market growth.
Providing
Our Product
Currently, both our products are still
in their product development phase. We believe that after successful clinical trials and product launch, we can quickly and significantly
grow sales volumes through marketing campaigns allowing the Company to capture market share. We are in a good position to expand
our customer base and convert customers into loyal, regular and recurring consumers of the brand. We believe the Company’s
products will be able to expand market share due to:
● | A scalable manufacturing and supply chain infrastructure; |
● | Being among the first using a sublingual strip to address smoking and vaping cessation in the $51.2 billion nicotine replacement therapy market. |
● | Its unique strip form “easy to use” delivery technology mechanism; and |
● | Its listing as an FDA homeopathic drug, although homeopathic drugs are not approved pursuant to an FDA registration. |
Suppliers
We anticipate opening a manufacturing
site for oral thin films (the “Redwood Factory”) in the United States within the next twelve months depending on funding
for the project. The Redwood Factory will be used exclusively to manufacture products for the Company.
The key value of the Redwood Factory
to us would be to stop outsourced manufacturing of oral strips and have better quality control over the manufacturing process
and active ingredients used in the oral thin film strips. The Redwood Factory will also allow for better control over trade secrets
by not allowing third parties access to formulas and active ingredients used in our products. We estimate that the cost of the
hardware required to manufacture the oral strips is approximately $300,000.
Once the Redwood Factory is established,
it may require FDA registration. The registration process for the Redwood Factory will be handled by our FDA counsel and will
entail registration of the active ingredients on the FDA website and a site visit by the FDA. Once the Redwood Factory is granted
its registration by the FDA, the registration would be used to register each product brought to market by Redwood with the FDA.
Product registration is based on FDA labelling guidelines and the process is done in the FDA registration portal as an FDA approved
OTC product subject to labelling guidelines by the Drugs Fact Panel. This is an important difference from a supplement facts panel
as they do not require FDA registration. Once the Redwood Factory and products receive FDA registration they will be in part of
the annual registration and updating process in the FDA system.
The
packaging of our products is manufactured in China. The Company’s ingredients are shipped from a Good Manufacturer Products
(“GMP”) certified supplier in the United States to ensure the highest quality. The average lead-time per production
batch ranges from five to seven days.
Intellectual
Property
We currently license a U.S. trademark
registration for the mark TBX-FREE, which is held my Inteli Property LLC, a Wyoming limited liability company whose controlling
member is Jason Cardiff, our chairman and CEO. We have a royalty-free, fully-paid, exclusive, worldwide, transferrable and
sublicensable right and license to use the TBX-FREE trademark in connection with our business. The licensing agreement is in effect
until Inteli Property LLC and Redwood terminate the agreement in writing. We are in the process of developing both TBX-FREE and
TBX-VAPE-FREE products, and we are in the process of developing patent strategy for both of the products, as well as applying
for registration of a trademark for TBX-VAPE-FREE. Our goal is to bring to market a long-term intellectual property portfolio
with a combination of both patents and trademarks that will sit around both formulations and the development of strip delivery
for active ingredients. We have filed with the Unites States Patent and Trademark Office (the “USPTO”) an extensive
patent regarding the manufacturing process of oral thin film strips as they relate to adding active ingredients up to 50 milligrams.
This is a design and use patent that will also work to protect the Company from infringement of other OTC treatments for lifestyle
issues. The patent has not yet been granted by the USPTO. If granted, we expect the patent would be for a term of 20 years.
Regulations
Numerous federal, state and local regulations
regulate nutritional supplements. The manufacturing, processing, formulation, packaging, labeling and advertising of our products
are subject to regulation by several federal agencies, including (i) the FDA, (ii) the FTC, (iii) the Consumer Product Safety
Commission, (iv) the United States Department of Agriculture, (v) the United States Postal Service, (vi) the United States Environmental
Protection Agency and (vii) the United States Occupational Safety and Health Administration. Failure to comply with these regulations
could have a material adverse effect on our business, financial condition and results of operations.
In
addition to OTC healthcare products and prescription drug products, the FDA regulates the safety, manufacturing, labeling and
distribution of dietary supplements, including vitamins, minerals and herbs, food additives, food supplements, OTC and prescription
drugs and cosmetics. The FTC also has overlapping jurisdiction with the FDA to regulate the promotion and advertising of vitamins,
over-the-counter drugs, cosmetics and foods.
Clinical
trials, product manufacturing, labeling, distribution and marketing of potential new products are also subject to federal and
state regulation in the United States and other countries. Clinical trials and product marketing and manufacturing are subject
to the rigorous review and approval processes of the FDA and foreign regulatory authorities. To obtain approval of a new drug
product, a company must demonstrate through adequate and well-controlled clinical trials that the drug product is safe and effective
for its intended use. Obtaining FDA and other required regulatory approvals is lengthy and expensive. Typically, obtaining regulatory
approval for pharmaceutical products requires substantial resources and may take several years. The length of this process depends
on the type, complexity and novelty of the product and the nature of the disease or other indication to be treated. Preclinical
studies must comply with FDA regulations. Clinical trials must also comply with FDA regulations to ensure safety of the human
subjects in the trial and may require large numbers of test subjects, complex protocols and possibly lengthy follow-up periods.
Consequently, satisfaction of government regulations may take several years causing delays in introducing potential new products
for considerable periods of time and may require imposing costly procedures upon our activities. If regulatory approval of new
products is not obtained in a timely manner or not at all, we could be materially adversely affected. Even if regulatory approval
of new products is obtained, such approval may impose limitations on the indicated uses for which the products may be marketed
which could also materially adversely affect our business, financial condition and future operations.
Under the Federal Food, Drug, and Cosmetic
Act (“FFDCA”), homeopathic products are subject to the same requirements related to approval, adulteration and misbranding
as other drug products. However, for decades, FDA has not required homeopathic drugs to be subjected to FDA new drug approval
prior to U.S. marketing through a well-known and widely regarded enforcement discretion policy. This is due to the fact that the
Homeopathic Pharmacopoeia of the United States (“HPUS”) pre-existed the enactment of the FFDCA and thus articles identified
in the HPUS are incorporated into the definition of the term “drug.” The HPUS included all active botanical ingredients
in use in homeopathy that are recognized as safe either OTC or subject to a physician’s prescription.
To facilitate industry understanding
of FDA’s enforcement priorities with respect to homeopathic drugs, in 1988, the FDA released Compliance Policy Guide (“CPG”)
400.400, entitled “Conditions Under Which Homeopathic Drugs May be Marketed,” which described the Agency’s then-current
enforcement policy. On October 24, 2019, FDA withdrew CPG 400.400 on the basis that it did not then accurately reflect FDA’s
risk-based approach to regulatory action and enforcement regarding homeopathic products. Yet, FDA continued to operate in practical
fashion under that prior guidance.
In December 2022, FDA issued a revised
guidance document for industry entitled, “Homeopathic Drug Products” Guidance for FDA Staff and Industry which, among
other things, discussed the history of CPG 400.400, explained the FDA’s efforts to re-examine its oversight over homeopathic
products with respect to enforcement and also set forth FDA’s risk-based methodology for evaluating and taking regulatory
action against certain types of homeopathic drug products going forward. Significantly, FDA’s guidance provides a robust
analysis of the regulatory posture and requirements applicable to homeopathic products. Among the salient details, the Guidance
underscored that in 1938, when the FFDCA was enacted, the bill added a provision to the law recognizing the HPUS alongside its
counterparts, the U.S. Pharmacopeia (USP) and the National Formulary (NF). Additionally, FDA noted that the definition of “drug”
in section 201(g)(1) of the FD&C Act (21 U.S.C. 321(g)) includes, among other articles, articles recognized in the HPUS or
any of its supplements.
Although FDA’s clarification
of its enforcement policy reiterated the status of homeopathic drugs as drugs being subject to all FDA requirements, it nonetheless
believed that it was in the “best interest of public health to issue a new guidance that applie[d] a risk-based enforcement
approach to homeopathic drug products marketed without the required FDA approval, consistent with FDA’s risk-based regulatory
approaches generally,” and regardless of product area or type. Notably, FDA identified certain categories of homeopathic
drug products marketed without the required FDA approval as potentially posing higher risks to public health: (1) Products with
reports of injury that, after evaluation, raise potential safety concerns; (2) Products that contain or purport to contain ingredients
associated with potentially significant safety concerns; (3) Products for routes of administration other than oral and topical;
(4) Products intended to be used for the prevention or treatment of serious and/or life-threatening diseases or conditions; (5)
Products for vulnerable populations; and (6) Products with significant quality issues.
We believe based on their intended
uses and target patient populations, none of Redwood’s products fall into any of the FDA’s new risk-based enforcement
criteria.
Political,
economic and regulatory influences are fundamentally changing the healthcare industry in the United States. Congress, state legislatures
and the private sector continue to review and assess alternative healthcare delivery and payment systems.
Employees
As of the date of this Registration
Statement, the Company has three employees and various consultants. We expect each of our employees to sign a confidentiality
and proprietary rights agreement.
Property
and Corporate Office
Our consultants and employees work
remotely and we have a mailing address at 418 Broadway, STE 4872, Albany, NY 12207.
Risks
related our Financial Condition
We
will need to obtain additional capital to support product development and commercialization programs.
Our
ability to achieve and sustain operating profitability depends in large part on our ability to commence and execute clinical trials
and commercialization of our products. The amount of capital that may be needed to complete product development will depend on
many factors which may include but are not limited to (i) the cost involved in clinical trials and applying for and obtaining
FDA, international regulatory or other technical approvals, as required, (ii) whether we elect to establish partnering arrangements
for development, sales, manufacturing and marketing of such products, (iii) the level of future sales of related products,
and (iv) whether we can establish and maintain strategic arrangements for development, sales, manufacturing and marketing of our
products.
Accordingly,
we may in the short and long term seek to raise capital through the issuance of securities or to secure other financing sources
to support our research, product technologies, applications, licensing, commercialization and other development opportunities.
If we obtain such funding through the issuance of equity securities, it would result in the dilution of current stockholders’
ownership in the Company. Any debt financing, if available, may include financial and other covenants that could restrict use
of proceeds of such financing or impose other business and financial restrictions on us. In addition, we may consider alternative
approaches such as licensing, joint venture, or partnership arrangements to provide long term capital. There can be no assurances
that we will have access to the capital required to fund these aspects of our business on favorable terms or at all.
If
we fail to raise additional capital, our ability to implement our business model and strategy could be compromised.
We
have limited capital resources and operations. To date, our operations have been largely funded from Jason Cardiff (our CEO and
majority stockholder) and his affiliates, which funding is treated as contributions to capital.
Based
on the Company’s past and anticipated operating expenses, we believe that the Company requires approximately $350,000 per
month on an annualized basis for operating expenses to fund the costs associated with our financing activities, legal and accounting
expenses, other general and administrative expenses, research and development, regulatory compliance, product development and
maintenance, third party manufacturing fees, and compensation of executive management and our employees. Based on our current
cash position, without additional financing we may not be able to pay our obligations past the fourth quarter of fiscal 2023.
The monthly cash requirement for operating expenses does not include any extraordinary items or expenditures. Furthermore,
we expect to incur additional costs associated with operating as a public company.
As
described in the report of our auditors for the years ended December 31, 2022 and 2021 and the notes to our financial statements,
there is substantial doubt about our ability to continue as a going concern, and if we are unable to continue, you may lose your
entire investment.
The uncertainty about our ability to continue in operation is based on our continuing losses from operation,
limited revenue and limited working capital, among other things which existed as of year-end December 31, 2022 and December 31,
2021. As of December 31, 2022, we had a cash balance of $0, working capital of $0 and an accumulated deficit of $5,275,421. Included
in the accumulated deficit are losses of $143,713 for the year ended December 31, 2022 and $0 for the year end December 31, 2021.
Given all these facts, we are dependent on obtaining funding from operations and the sale of debt or equity to continue as a going
concern. The financial statements do not include any adjustments relating to the recoverability of assets and classification of
liabilities that might be necessary should we be unable to continue as a going concern.
Our
ability to continue as a going concern depends on receipt of additional funds through debt or equity financing and our operations.
In the event we are unable to obtain such funding, we may have to delay, reduce or eliminate certain of our planned operations,
including some of our research and development and/or clinical trials, reduce overall overhead expense, or divest assets. This
in turn may have an adverse effect on our ability to realize the value of our assets. If we are unable to continue as a going
concern, you may lose all or part of your investment.
Risks
Related To Our Business
We
are heavily dependent on the successful development and commercialization of TBX-FREE and TBX-VAPE-FREE, and if we encounter delays
or difficulties in the development of our product candidates, we may not generate sufficient revenue to continue our business
operations and our business could be harmed.
TBX-FREE
and TBX-VAPE-FREE are currently in the early stage of development and will require substantial time, resources, research and development,
and regulatory approval. To generate sales revenue from our product candidates, we must conduct extensive clinical trials to demonstrate
that our product candidates are safe and effective and we must obtain required regulatory approvals. We will need to devote significant
additional research and development, financial resources, and personnel to develop commercially viable products. It is likely
to take several months to obtain the required regulatory approvals for our product candidates, or we may never gain the necessary
approvals.
Many
companies in healthcare industries have suffered significant setbacks in clinical trials, and we cannot be certain that we will
not face similar setbacks. Significant adverse effects caused by, or other unexpected properties of, a regulatory authority to
interrupt, delay or halt clinical trials of one or more of such product candidates could result in a more restrictive label or
the delay or denial of marketing approval by the FDA or comparable non-U.S. regulatory authorities. If any product candidate we
may choose to develop is associated with significant adverse effects or other unexpected properties, we may need to abandon development
or limit development of that product candidate to certain uses or subpopulations in which those undesirable characteristics would
be expected to be less prevalent, less severe or more tolerable from a risk-benefit perspective. Moreover, clinical data is often
susceptible to varying interpretations and analyses, and many companies that believed their product candidates performed satisfactorily
in clinical trials nonetheless failed to obtain FDA or other regulatory authority approval. If we fail to produce positive results
in clinical trials of our product candidates, the development timeline and regulatory approval and commercialization prospects
for our product candidates, and, correspondingly, our business and financial prospects, would be negatively impacted. If we fail
to obtain such approvals, we may not generate sufficient revenues to continue our business operations.
Even
if we obtain regulatory approval of a product, that approval may be subject to limitations on the indicated uses for which it
may be marketed. Even after granting regulatory approval, the FDA and regulatory agencies in other countries continue to review
and inspect marketed products, manufacturers, and manufacturing facilities, which may create additional regulatory burdens. Later
discovery of previously unknown problems with a product, manufacturer, or facility may result in restrictions on the product or
manufacturer, including a withdrawal of the product from the market or a withdrawal of the approved application by the FDA. Furthermore,
the FDA may require post-approval studies or other commitments from us, and failure to comply with or meet those commitments could
result in withdrawal of the approved application by FDA. Regulatory agencies may also establish additional regulations, policies,
or guidance that could prevent or delay regulatory approval of our product candidates.
As
a result, our business could be materially harmed if we encounter difficulties in the development of product candidates, such
as:
● | delays in the design, enrollment, implementation or completion of required clinical trials; |
● | an inability to follow our current development strategy for obtaining regulatory approval from regulatory authorities because of changes in the regulatory approval process; and |
● | less than desired or complete lack of efficacy or safety in clinical trials. |
If
any of the above were to occur, this could significantly and adversely affect the development and commercialization of TBX-FREE,
TBX-VAPE-FREE or other products and could have a material adverse effect on our business, financial condition, and results of
operations.
Our
future success depends on the sales of our principal products and effective distribution channels.
We
depend on the successful launch and continued acceptance of TBX-VAPE-FREE by our customers and establishing distribution
channels for our products. Every TBX-VAPE-FREE oral strip contains a precisely measured dose of cytosine – the active ingredient
that reduces the urge to vape. Our distribution channels are critical to achieve product and brand awareness with potential consumers.
However, there can be no assurance that our products will receive, maintain or increase market acceptance. The inability
to successfully commercialize our products and expand product distribution, for any reason, would have a material adverse
effect on our financial condition, prospects and ability to continue operations.
If
the potential of our product candidates to treat nicotine cessation is not realized, the value of our technology and our development
programs could be significantly reduced.
We are currently conducting clinical trials with the intent to establish safety, tolerability and efficacy
of TBX-FREE and TBX-VAPE-FREE. We have not yet proven in clinical trials that TBX-FREE and TBX-VAPE-FREE will be safe and effective
treatments for nicotine cessation. These product candidates are susceptible to various risks, including inadequate therapeutic
efficacy, or other characteristics that may prevent or limit their marketing approval or commercial use. We have not yet completed
all of the testing necessary to allow us to make a determination that serious unintended consequences will not occur. If the potential
of these product candidates to treat nicotine cessation is not realized, the value of our technology and our development programs
could be significantly reduced. Additionally, because our product candidates are based on cytosine, any negative developments regarding
the therapeutic potential or side effects of cytosine, or to scientific and medical knowledge about cytosine in general, could
have a material adverse effect on our business, financial condition, results of operations, and prospects.
We
have a limited operating history with our current business model, which may make it difficult for you to evaluate our current
business and predict our future success and viability.
Our
business is in the early clinical development stage with a limited operating history with our current business model upon which
you can evaluate our business and prospects. Our historical operations were limited to TBX-FREE and sales direct to consumers.
We transitioned our business model and we have devoted substantially all of our resources and efforts to reorganizing and staffing
our company, business planning, expanding our research and development capabilities, raising capital, developing product candidates,
pursuing related intellectual property rights and organizing clinical trials of TBX-FREE and TBX-VAPE-FREE.
Our
limited operating history with our current business model may make it more difficult for us to succeed or for investors to evaluate
our business and prospects. In addition, we have limited experience in development activities, including conducting clinical trials,
or seeking and obtaining regulatory approvals, even though certain of our executives have had relevant experience at other companies.
We will also need to be a company capable of conducting clinical trials and, if successful, supporting commercial activities of
our products. Such a transition will involve substantial additional capital requirements to launch our products. To execute our
business plan, we will need to successfully:
● | execute our product candidate development activities, including successfully completing our clinical trial programs; |
● | obtain required regulatory approvals or authorizations for the development and commercialization of our product candidates; |
● | manage our costs and expenses related to clinical trials, regulatory approvals, manufacturing and commercialization; |
● | secure substantial additional funding; |
● | develop and maintain successful strategic relationships; |
● | maintain a strong intellectual property portfolio; |
● | build and maintain appropriate clinical, sales, manufacturing and distribution capabilities on our own or through third parties; and |
● | gain market acceptance and favorable reimbursement status for our product candidates. |
If
we are unsuccessful in accomplishing these objectives, we may not be able to develop product candidates, raise capital or expand
our business, or continue our operations.
We
are early in our efforts to develop TBX-FREE and TBX-VAPE-FREE. If we are unable to advance TBX-FREE or TBX-VAPE-FREE through
clinical trials, obtain regulatory approval and ultimately commercialize such product candidates, or if we experience significant
delays in doing so, our business will be materially harmed.
We
must conduct extensive clinical trials to demonstrate the safety and efficacy of each product candidates for their intended indications.
Clinical trials are expensive, time consuming and uncertain as to outcome. We cannot guarantee that any clinical trials will be
conducted as planned or completed on schedule, if at all. A failure of one or more clinical trials can occur at any stage of testing.
Events that may prevent successful or timely completion of clinical development include:
● | delays in reaching a consensus with regulatory authorities on trial design; |
● | delays in opening sites and recruiting individuals to participate in our clinical trials; |
● | suspension of our clinical trials if it is determined that we or our collaborators are failing to conduct a trial in accordance with regulatory requirements; or |
● | changes in regulatory requirements and guidance that require amending or submitting new clinical protocols. |
Additionally,
if the results of our clinical trials are inconclusive or if there are safety concerns or serious adverse events associated with
our drug candidates, we may:
● | be delayed in obtaining marketing approval, if at all, or be required to conduct additional confirmatory safety and/or efficacy studies; |
● | obtain approval with labeling that includes significant use or distribution restrictions or safety warnings; |
● | be required to perform additional clinical trials; |
● | have regulatory authorities withdraw, or suspend, their approval of the products or impose restrictions on their distribution; |
● | be subject to the addition of labeling statements, such as warnings or contraindications; |
● | experience damage to our reputation. |
Our
product candidates represent new classes of therapy that the marketplace may not understand or accept.
Even
if we successfully develop our product candidates, the market may not understand or accept them. We are developing product candidates
that represent novel treatment approaches and will compete with a number of more conventional products and therapies manufactured
and marketed by others, including major pharmaceutical companies. The degree of market acceptance of any of our developed and
potential products will depend on a number of factors, including the clinical effectiveness of our products and their perceived
advantage over alternative treatment methods and our ability to demonstrate that our products can have a clinically significant
effect for smoking and vaping cessation.
If
the marketplace does not accept our product candidates or future approved products for any of the foregoing reasons, or for any
other reason, it could affect our sales or have a material adverse effect on our business, financial condition, results of operations,
and prospects.
We depend on certain important
employees and consultants, and the loss of any of those employees or consultants may harm our business.
The
success of our business will continue to be highly dependent upon Jason Cardiff, CEO, John Harrington, CFO and David Duncan, COO.
The loss of services of any of these persons could have a materially adverse effect upon our business and development.
Our
business is subject to significant competitive pressures.
The
OTC healthcare product, life science, homeopathic drug market, and consumer product industries are highly competitive. Many of
our competitors have substantially greater capital resources, technical staffs, facilities, marketing resources, product development,
distribution and experience than we do. Our competitors may have certain advantages, including the ability to allocate greater
resources for new product development, marketing and other purposes. Further, our competitors may develop new products that are
safer, more effective, or more cost-efficient than cytisine. Large pharmaceutical companies in particular have extensive expertise
in non-clinical and clinical testing and in obtaining regulatory approvals for products. In addition, academic institutions, government
agencies, and other public and private organizations conducting research may seek patent protection with respect to potentially
competitive products or technologies. These organizations may also establish exclusive collaborative or licensing relationships
with our competitors. Failure of cytisine to effectively compete against established treatment options or in the future with new
products currently in development would harm our business, financial condition, results of operations and prospects.
We believe that our ability to compete
depends on a number of factors, including product quality and price, availability, speed to market, consumer marketing, reliability,
credit terms, brand name recognition, delivery time and post-sale service and support, and new and existing product innovation
and commercialization. There can be no assurance that we will be able to compete successfully in the future. There are a
number of existing competing OTC healthcare products and prescription products for nicotine replacement therapy, including Nicorette,
Chantix and NicoDerm CQ. We face competition from major pharmaceutical companies, specialty pharmaceutical companies, biotechnology
companies, universities and other research institutions worldwide with respect to cytisine and the other product candidates that
we may seek to develop or commercialize in the future. We are aware that many companies have therapeutics marketed or in development
for smoking cessation, including, Johnson & Johnson, Pfizer Inc., GlaxoSmithKline Plc, Merck & Co., Novartis, Invion,
Embera Neurotherapeutics, Achieve Life Sciences, Inc., 22nd Century Group, Inc., Quit4Good, zpharm, Chrono Therapeutics, NAL Pharmaceuticals,
Selecta Biosciences, Aradigm, Adamed, Aflofarm, Axsome, Smoke Free Therapeutics, Antidote Therapeutics and others.
Though we have successfully competed with
these other products in the past, the continued success of our business model is dependent on our ability to continue to develop
our products and to retain a significant share of the market. If we are unable to compete effectively, our earnings may be significantly
negatively impacted.
If
our competitors develop similar or comparable treatments for the target indications of our product candidates that are approved
more quickly, marketed more successfully or are demonstrated to be more effective than our product candidates, our commercial
opportunity will be reduced or eliminated.
We
compete in an industry characterized by intense competition, a changing regulatory and legislative landscape and a strong emphasis
on the benefits of intellectual property protection and regulatory exclusivities. Our competitors include other biotechnology
companies, pharmaceutical companies, and other private and public organizations. TBX-FREE and TBX-VAPE-FREE or any future product
candidates, if successfully developed and approved, may compete with established therapies and with new treatments that may be
introduced by our competitors.
Many
of our competitors and potential competitors have substantially greater scientific, research, and product development capabilities,
as well as greater financial, marketing, sales and human resources capabilities than we do. Accordingly, our competitors may be
more successful with respect to their products than we may be in developing, commercializing, and achieving widespread market
acceptance for our products. In addition, our competitors’ products may be more effective or more effectively marketed and
sold than any treatment we may commercialize and may render our product candidates obsolete or non-competitive before we can recover
the expenses related to developing and supporting the commercialization of any of our product candidates. Developments by competitors
may render our product candidates obsolete or noncompetitive. The more established companies may have a competitive advantage
over us due to their size, cash flows, institutional experience and historical corporate reputation.
If
our outside suppliers, manufacturers and distributers fail to supply products in sufficient quantities and in a timely fashion,
our business could suffer.
We
are dependent on third-party manufacturers and suppliers to make and supply all of our products. We do not have long-term agreements
with our manufacturers or suppliers. Our profit margins and timely product delivery are dependent upon the ability of our outside
suppliers and manufacturers to supply us with products in a timely and cost-efficient manner. Our ability to develop our business
and enter new markets and sustain satisfactory levels of sales in each market depends upon the ability of our outside suppliers
and manufacturers to produce the ingredients and products and to comply with all applicable regulations. The failure of our primary
suppliers or manufacturers to supply ingredients or produce our products could adversely affect our business operations.
We
do not have long-term contracts with suppliers, manufacturers and distributors and we are dependent on the services of these third
parties.
We
will purchase all of our products from third-party suppliers and manufacturers pursuant to purchase orders, but without any long-term
agreements. In the event that a current supplier or manufacturer is unable to meet our manufacturing and delivery requirements
at some time in the future, we may suffer short-term interruptions of delivery of certain products while we establish an alternative
source. We will also rely on third-party carriers for product shipments, including shipments to and from our distribution facilities.
We are therefore subject to the risks, including employee strikes and inclement weather, associated with our carrier’s ability
to provide delivery services to meet our fulfillment and shipping needs. Failure to deliver products to our customers in a timely
and accurate manner would harm our reputation and our business and results of operations.
If
the outside contractors we will use for production of our products fail to produce product in the volumes and quality that we
require on a timely basis, we may be unable to meet demand for our products and may lose potential revenues.
We
will contract with specially equipped contractors to handle the large-scale mixing of the formulation components in our products.
These external contractor relationships entail added costs and potential disruption to our finished goods schedule. These third-party
contractors may encounter difficulties in production, including problems with quality control, quality assurance testing, shortages
of qualified personnel, and compliance with federal, state and or other governmental regulations. Our contractors may not be able
to expand capacity or to produce additional product requirements for us in the event that demands for our products increases.
There can be no assurance that our contractors will be able to continue purchasing raw materials for our products from current
suppliers or any other supplier on terms similar to current terms or at all. If these contractors were to encounter any of these
difficulties, or experience any interruption in the availability of certain ingredients or significant increases in the prices
paid for such materials, our ability to fulfill orders on a timely basis to our customers would be jeopardized.
If
we do not manage product inventory in an effective and efficient manner, our profitability could be adversely affected.
Many
factors affect the efficient use and planning of product inventory, such as effectiveness of predicting demand, effectiveness
of preparing manufacturing to meet demand, efficiently meeting product mix and product demand requirements and product expiration.
We may be unable to manage our inventory efficiently, keep inventory within expected budget goals, or keep sufficient product
on hand to meet demand. If we fail to manage inventory effectively, we may end up with unsold inventory that is past its expiration
date and can no longer be sold. We periodically evaluate the composition of inventory and estimate an allowance to reduce inventory
for slow moving, obsolete or damaged inventory. Our failure to manage inventory effectively may lead to increased costs and adversely
affect our results of operations.
Retail
customer’s strategic business plans may negatively influence the distribution of our products to consumer.
Changes
in our retail and distribution customers strategic business plans including, but not limited to, (i) expansions, mergers, and/or
consolidations, (ii) retail shelf space allocations for products within each outlet and in particular the smoking/vaping category
in which we compete, (iii) changes in their private label assortment and (iv) product selections, distribution allocation, merchandising
programs and retail pricing of our products as well as competitive products could affect the consumer sales of our products
and could result in a material adverse effect to our business and financial condition.
Our
products and potential new products are or may be subject to extensive governmental regulation.
Our
business is regulated by various agencies, including federal and state agencies, where our products are sold. Governmental regulations
in foreign countries where we manufacture our products, or plan to commence sales may prevent or delay entry into a market or
prevent or delay the introduction, or require the reformulation of certain of our products. In addition, no prediction can be
made as to whether new domestic or foreign legislation regulating our activities will be enacted. Any new legislation could have
a material adverse effect on our business, financial condition and operations. Non-compliance with any applicable requirements
may subject us or the manufacturers of our products to agency action, including warning letters, fines, product recalls, seizures
and injunctions.
The
manufacturing, processing, formulation, packaging, labeling and advertising of our products are subject to regulation by several
federal agencies, including (i) the FDA, (ii) the FTC, (iii) the Consumer Product Safety Commission, (iv) the United States
Department of Agriculture, (v) the United States Postal Service, (vi) the United States Environmental Protection Agency and (vii)
the United States Occupational Safety and Health Administration.
In addition to OTC healthcare products
and prescription drug products, the FDA regulates the safety, manufacturing, labeling and distribution of dietary supplements,
including vitamins, minerals and herbs, food additives, food supplements, OTC and prescription drugs and cosmetics. The FTC also
has overlapping jurisdiction with the FDA to regulate the promotion and advertising of vitamins, over-the-counter drugs, cosmetics
and foods. In addition, our products are considered homeopathic remedies, which are subject to standards established by the HPUS.
HPUS sets the standards for source, composition and preparation of homeopathic remedies which are officially recognized under
the Federal Food, Drug and Cosmetics Act, as amended.
Preclinical
development, clinical trials, product manufacturing, labeling, distribution and marketing of potential new products are also subject
to federal and state regulation in the United States and other countries. Consequently, satisfaction of government regulations
may take several years, may cause delays in introducing potential new products for considerable periods of time, and may require
imposing costly procedures upon our activities. If regulatory approval of our products is not obtained in a timely manner or not
at all, we could be materially adversely affected. Even if regulatory approval of new products is obtained, such approval may
impose limitations on the indicated uses for which the products may be marketed which could also materially adversely affect our
business, financial condition and future operations.
Consumers’ ability to successfully
file a complaint against us and our products may be greater due to the homeopathic status of our products.
Under
the Federal Food, Drug, and Cosmetic Act (the “FDCA”) homeopathic products are subject to the same requirements related
to approval, adulteration and misbranding as other drug products. Currently, there are currently no FDA-approved products
labeled as homeopathic. Homeopathic drugs must meet the standards of strength, quality, and purity set forth in the HPUS. FDA
has established a policy addressing the products labeled as homeopathic drugs under the Federal Food, Drug, and Cosmetic Act describing
how FDA intends to prioritize enforcement and regulatory actions for homeopathic drug products marketed in the United States without
the required FDA approval. The FDA is prioritizing specific categories of drugs, such as those intended for populations at greater
risk for adverse reactions.
In
recent years, state courts have concluded that, because homeopathic drugs are not approved or marketed pursuant to an FDA
regulation, claims against a manufacturer of a homeopathic drug are not preempted by the FDCA. Consequently, plaintiff’s
actions under state consumer protection laws for lack of substantiation have been allowed to proceed. Ignoring the unique character
of homeopathic drug products, plaintiff’s claims in these actions have been based on the evidence standard applied to conventional
drugs. Generally, these actions involve claims for significant monetary damages.
The
implementation of new regulations governing the marketing and sale of nutritional supplements could harm our business.
There
has been an increasing movement in the U.S. and other jurisdictions to increase the regulation of supplements, which could impose
additional restrictions or requirements on the marketing and sale of such products. For example, in the U.S., there has been
a push to increase the FDA’s regulatory authority of nutritional supplements. Our business could be harmed if more restrictive
legislation is successfully introduced and adopted in the future. Currently, our products are not categorized as supplements.
Nutritional supplement products are not subject to pre-market FDA approval. If regulations are adopted to require pre-market approval
of supplements or ingredients, our sale and release of new product could be delayed or inhibited. The adoption of similar laws
in other countries in which we intend to expand sales of our products could also harm our business. The FTC approved revisions
to its Guides Concerning the Use of Endorsements and Testimonials in Advertising (“Guides”) in December 2009. The
Guides state that advertisements that feature a consumer and his or her atypical experience with a product must clearly disclose
the results that consumers generally can expect with such product. In addition, the Guides require disclosure of any material
connections between an endorser and the company whose products he or she is endorsing. If we fail to comply with the Guides, the
FTC could bring an enforcement action against us and we could be fined and/or forced to alter our marketing strategy.
Our
third-party manufacturers’ failure to comply with good manufacturing practices could harm our business operations.
All
manufacturers and suppliers of OTC products must comply with applicable current good manufacturing practice, or cGMP, regulations
for the manufacture of our products, which are enforced by the FDA through its facilities inspection program. The FDA may conduct
inspections of our third-party manufacturers to assure that they are in compliance with such regulations. These cGMP requirements
include quality control, quality assurance and the maintenance of records and documentation, among other items. Our manufacturers
may be unable to comply with these cGMP requirements and with other regulatory requirements. A failure to comply with these requirements
may result in fines, product recalls or seizures and related publicity requirements, injunctions, total or partial suspension
of production, civil penalties, warning or untitled letters, import or export bans or restrictions, and criminal prosecution and
penalties. Any of these penalties could delay or prevent the promotion, marketing or sale of our products. If the safety of any
products supplied to us is compromised due to a third-party manufacturer’s failure to adhere to applicable laws or for other
reasons, we may not be able to successfully sell our products. We cannot assure that our third-party manufacturers will continue
to reliably supply products to us at the levels of quality, or the quantities, we require, and in compliance with applicable laws
and regulations, including cGMP requirements.
The productions of our products’
packaging is located in China, which exposes us to risks associated with doing business in that geographic area to include foreign
currency risk.
The packaging of our products is produced
in China. Our operations in China could be adversely affected by changes in the interpretation and enforcement of legal
standards, by strains on China’s available labor pool, changes in labor costs and other employment dynamics, high turnover
among employees, communications, trade, and other infrastructures, by natural disasters, by conflicts or disagreements between
China and the United States, by labor unrest, and by other trade customs and practices that are dissimilar to those in the United
States. Interpretation and enforcement of China’s laws and regulations continue to evolve and we expect differences in interpretation
and enforcement to continue in the foreseeable future.
Further,
we may be exposed to fluctuations in the value of the local currency in the countries in which manufacturing occurs. Future appreciation
of these local currencies could increase our component and other raw material costs. In addition, our labor costs could continue
to rise as wage rates increase and the available labor pool declines. These conditions could adversely affect our gross margins
and financial results.
In
the event of a disruption of this facility, we would need to outsource to other third parties, at least temporarily, our manufacturing.
While we have identified such secondary sources for our products, if we are unable to find other sources or there were a delay
in the ramp-up for the production and distribution operations for some of our products, it could have a material adverse effect
on our operations.
Our
inability to find alternative sources for our manufacturing needs may have a material adverse effect on our operations and financial
condition. In addition, the terms on which manufacturers and suppliers will make products and raw materials available to us could
have a material effect on our success.
Impediments
to global shipping lanes can delay crucial deliveries and negatively impact our business, financial condition and results of operations.
Both
our receipt of product packaging components and our shipment of finished goods depend heavily on ship cargo container delivery.
Threats of dock workers’ strikes highlight our potential vulnerability to shipping interruption. Any shipment delays in
obtaining our product packaging or shipping our finished products to our customers could negatively impact our business, financial
condition and results of operations.
We
are uncertain as to whether we can protect our proprietary rights.
The strength of our patent position
and proprietary formulations and compounds may be important to our long-term success. We have applied for a U.S. patent in connection
with TBX-FREE and TBX-VAPE-FREE, however there can be no assurance that these patents and proprietary formulations and compounds
will effectively protect our products from duplication by others. In addition, we may not be able to afford the expense of any
litigation which may be necessary to enforce our rights under any of the patents. Furthermore, there can be no assurance that
third parties will not obtain access to or independently develop our technologies, know-how, ideas, concepts and documentation,
which could have a material adverse effect on our financial condition.
Although
we believe that current and future products do not and will not infringe upon the patents or violate the proprietary rights of
others, if any of our current or future products do infringe upon the patents or proprietary rights of others, we may have to
modify the products or obtain an additional license for the manufacture and/or sale of such products. We could also be prohibited
from selling the infringing products. If we were found to infringe on the proprietary rights of others, it is uncertain whether
we would be able to take corrective actions in a timely manner, upon acceptable terms and conditions, or at all, and the failure
to do so could have a material adverse effect upon our business, financial condition and operations.
We
may in the future file patent litigation claims in the U.S. and foreign jurisdictions to protect our patent portfolio. If we are
unsuccessful in these claims, our business, financial condition and results of operations could be adversely affected.
We
may initiate litigation to assert claims of infringement, enforce our patents, protect our trade secrets or know-how, or determine
the enforceability, scope and validity of the proprietary rights of others. Any lawsuits that we initiate could be expensive,
time consuming and divert management’s attention from other business concerns. Furthermore, litigation may provoke third
parties to assert claims against us and may put our patents at risk of being invalidated or interpreted narrowly and our patent
applications at risk of not being issued.
In
addition, we may not prevail in lawsuits that we initiate, and the damages or other remedies awarded, if any, may not be commercially
valuable. The occurrence of any of these events may have a material adverse effect on our business, financial condition, and results
of operations.
If
our patents and other intellectual property rights do not adequately protect our products, we may lose market share to our competitors
and be unable to operate our business profitably.
Patents
and other proprietary rights may be essential to our business, and our ability to compete effectively with other companies depends
on the proprietary nature of our technologies. We also rely upon trade secrets, know-how, continuing technological innovations
and licensing opportunities to develop, maintain and strengthen our competitive position. We seek to protect these, in part, through
confidentiality agreements with certain employees, consultants and other parties. We plan to pursue a policy of generally obtaining
patent protection in both the United States and key foreign countries for patentable subject matter in our proprietary products
and also attempt to review third-party patents and patent applications to the extent publicly available to develop an effective
patent strategy, avoid infringement of third-party patents, identify licensing opportunities and monitor the patent claims of
others. We cannot assure you that any pending or future patent applications will result in issued patents, that any current or
future patents issued or licensed to us will not be challenged, invalidated or circumvented or that the rights granted thereunder
will provide a competitive advantage to us or prevent competitors from entering markets that we currently serve. Any required
license may not be available to us on acceptable terms, if at all. In addition, some licenses may be non-exclusive, and therefore
our competitors may have access to the same technologies as we do. Furthermore, we may have to take legal action in the future
to protect our trade secrets or know-how, or to defend them against claimed infringement of the rights of others. Any legal action
of that type could be costly and time-consuming to us, and we cannot assure you that such actions will be successful. The invalidation
of key patents or proprietary rights that we own or unsuccessful outcomes in lawsuits to protect our intellectual property may
have a material adverse effect on our business, financial condition, and results of operations.
The
laws of foreign countries may not protect our intellectual property rights to the same extent as the laws of the United States.
If we cannot adequately protect our intellectual property rights in these foreign countries, our competitors may be able to compete
more directly with us, which could adversely affect our competitive position and, as a result, our business, financial condition
and results of operations.
Our
products expose us to potential product liability claims.
Our
business results in exposure to an inherent risk of potential product liability claims, including claims for serious bodily injury
or death caused by the sales of our existing product and the products which are being developed. These claims could lead to substantial
damage awards. While we currently maintain product liability insurance, a successful claim brought against us in excess of,
or outside of, existing insurance coverage could have a material adverse effect on our results of operations and financial condition.
Claims against us, regardless of their merit or eventual outcome, may also have a material adverse effect on the consumer demand
for our products.
If
we experience product recalls, we may incur significant and unexpected costs, and our business reputation could be adversely affected.
We
may be exposed to product recalls and adverse public relations if our products are alleged to cause injury or illness, or if we
are alleged to have violated governmental regulations. A product recall could result in substantial and unexpected expenditures,
which would reduce operating profit and cash flow. In addition, a product recall may require significant management attention.
Product recalls may hurt the value of our brands and lead to decreased demand for our products. Product recalls also may lead
to increased scrutiny by federal, state or international regulatory agencies of our operations and increased litigation and could
have a material adverse effect on our business, results of operations, financial condition and cash flows.
We
are highly dependent upon consumers’ perception of the safety and quality of our products as well as similar products distributed
by other companies in our industry; adverse publicity and negative public perception regarding particular ingredients or products
or our industry in general could limit our ability to increase revenue and grow our business.
Decisions
about purchasing made by consumers of our products may be affected by adverse publicity or negative public perception regarding
particular ingredients or products or our industry in general. This negative public perception may include publicity regarding
the legality or quality of particular ingredients or products in general or of other companies or our products or ingredients
specifically. Negative public perception may also arise from regulatory investigations, regardless of whether those investigations
involve us. We are highly dependent upon consumers’ perception of the safety and quality of our products as well as similar
products distributed by other companies. Thus, the mere publication of reports asserting that such products may be harmful could
have a material adverse effect on us, regardless of whether these reports are scientifically supported. Publicity related to nutritional
supplements and OTC healthcare and wellness products may also result in increased regulatory scrutiny of our industry. Adverse
publicity may have a material adverse effect on our business, financial condition, and results of operations. There can be no
assurance of future favorable scientific results and media attention or of the absence of unfavorable or inconsistent findings.
We
face intense competition from competitors that are larger, more established and that possess greater resources than we do, and
if we are unable to compete effectively, we may be unable to maintain sufficient market share to sustain profitability.
Numerous
manufacturers and retailers compete actively for our consumers. There can be no assurance that we will be able to compete in this
intensely competitive environment. In addition, nutritional supplements and OTC healthcare and wellness products can be purchased
in a wide variety of channels of distribution. These channels include mass market retail stores and the Internet. Because these
markets generally have low barriers to entry, additional competitors could enter the market at any time. Private label products
of our customers also provide competition to our products. Additional national or international companies may seek in the future
to enter or to increase their presence in the OTC healthcare and wellness products. Increased competition in either or both could
have a material adverse effect on us.
If
our current and planned sales, marketing and servicing capabilities or entry into arrangements with third parties to sell and
market our products and services adversely changes, our business may be harmed.
We
plan to distribute our products to retail stores and online stores, and utilize various approaches for marketing and distribution
of our products and services. If we develop our own marketing and sales capabilities, our sales force will be competing with the
experienced and well-funded marketing and sales operations of our competitors. Developing a sales force is expensive and time-consuming
and could delay or limit the success of any product launch. We may not be able to develop this capacity on a timely basis or at
all. If we contract with third parties to market and sell our products and services, our revenues could be lower than if we directly
marketed and sold our products and services. Furthermore, to the extent that we enter into co-promotion or other marketing and
sales arrangements with other companies, any revenues received will depend on the skills and efforts of others, and we do not
know whether these efforts will be successful. Some of our future distributors may have products or product candidates that compete
with ours, and they may have an incentive not to devote sufficient efforts to marketing our products. If we are unable to establish
and maintain adequate sales, marketing and distribution capabilities, independently or with others, we may not be able to generate
product revenue and may not become profitable.
There
can be no assurance as to how much revenue our business will generate, and we may need substantial additional funding to support
the business. We may be unable to raise capital when needed, which would force us to delay, reduce or eliminate our product development
programs and acquisitions.
Our
future funding requirements will depend on many factors, including:
● | the scope, rate of progress and cost of our development activities; |
● | the cost of defending, in litigation or otherwise, any claims that we infringe third party patents or other intellectual property rights; |
● | the cost and timing of regulatory approvals; |
● | the cost and timing of establishing sales, marketing and distribution capabilities; |
● | the cost of establishing clinical and commercial supplies of our product candidates and any products that we may develop; and, |
● | the effect of competing technological and market developments. |
Until
we can generate a sufficient amount of revenue, if ever, we expect to finance future cash needs through equity offerings, debt
financings, corporate collaborations, and licensing arrangements. If we raise additional funds by issuing equity securities, our
stockholders may experience dilution. Any debt financing or additional equity that we raise may contain terms that are not favorable
to our stockholders. If we raise additional funds through collaboration and licensing arrangements with third parties, it may
be necessary to relinquish some rights to our technologies or our product candidates, or grant licenses on terms that are not
favorable to the Company. If we are unable to raise adequate funds, we may have to liquidate some or all of our assets or delay,
reduce the scope of or eliminate some or all of our development programs.
Failure
to protect against security breaches and inappropriate use by Internet users could adversely affect us.
We
collect and retain a large amount of internal and customer data, including personally identifiable information about our employees.
The security of this data may potentially be breached due to a number of risks, including cyber-attack, system failure, human
error, computer virus, or unauthorized or fraudulent use by customers or company employees. Any failure on our part to effectively
prevent security breaches could significantly harm our business, reputation and results of operations and could expose us to lawsuits
by state and federal consumer protection agencies, by governmental authorities in the jurisdictions in which we operate, and by
consumers. Anyone who is able to circumvent our security measures could misappropriate proprietary information, including
customer credit card and personal data, cause interruptions in our operations or damage our brand and reputation. Such breach
of our security measures could involve the disclosure of personally identifiable information and could expose us to a material
risk of litigation, liability or governmental enforcement proceedings. We cannot assure you that our systems are completely
secure from security breaches or sabotage. We may be required to incur significant additional costs to protect against security
breaches or to alleviate problems caused by such breaches. Any well-publicized compromise of our security or the security of any
other Internet provider could deter people from purchasing our products, which could adversely affect our sales and results of
operations.
Computer
viruses may cause delays or other service interruptions, which may materially adversely affect our ability to operate our business
and result in damage to our reputation. If a computer virus affecting the Internet in general is highly publicized or particularly
damaging, our customers may not use the Internet or may be prevented from using the Internet, which would have an adverse effect
on sales of our products. The inadvertent transmission of computer viruses could also expose us to a material risk of loss or
litigation and possible liability. The Company may be required to expend capital and resources to protect against or alleviate
system failures or disruptions, which could negatively affect our results of operations.
We have material weaknesses in
our internal control over financial reporting which could adversely affect our ability to report our financial condition and results
of operations accurately and on a timely basis.
We currently have material weaknesses in our internal
control over financial reporting relating to segregation of duties that could adversely impact our ability to provide timely and accurate
financial information. We are developing remediation plans to strengthen our internal controls in response to the previously identified
material weaknesses. The remediation plan includes hiring an adequate number of qualified accounting staff and assigning duties in a
manner to provide sufficient controls and procedures. The Company intends to begin the remediation plan when it has adequate resources
to do so. If we are unsuccessful in developing, implementing or following our remediation plans, or fail to update our internal controls
as our business evolves, we may not be able to timely or accurately report our financial condition, results of operations or cash flows
or maintain effective disclosure controls and procedures. If we are unable to report financial information timely and accurately or to
maintain effective disclosure controls and procedures, we could be subject to, among other things, regulatory or enforcement actions
by the SEC, securities litigation and a general loss of investor confidence, any one of which could adversely affect our business prospects
and the valuation of our Common Stock.
Furthermore,
there are inherent limitations to the effectiveness of any system of controls and procedures, including the possibility of human error
and the circumvention or overriding of the controls and procedures. We could face additional litigation exposure and a greater likelihood
of an SEC enforcement regulatory action if further restatements were to occur or other accounting-related problems emerge.
Risks
Related to Our Securities
We
may in the future issue additional shares of our Common Stock which would reduce investors’ ownership interests in the Company
and which may dilute our share value.
Our amended and restated certificate of
incorporation (the “Certificate of Incorporation”), and any amendments thereto, authorize the issuance of 495,000,000
shares of Common Stock, and 5,000,000 shares of preferred stock, par value $0.001 per share (the “Preferred Stock”).
The future issuance of all or part of our remaining authorized Common Stock may result in substantial dilution in the percentage
of our Common Stock held by our then existing stockholders. The issuance of Common Stock for future services or acquisitions or
other corporate actions may have the effect of diluting the value of the shares held by our investors and might have an adverse
effect on any trading market for our Common Stock.
Our
charter documents may have anti-takeover effects that could prevent a change in control.
Our Certificate of Incorporation or our
bylaws could make it more difficult for a third party to acquire us, even if closing such a transaction would be beneficial to
our stockholders. We are authorized to issue up to 5,000,000 shares of Preferred Stock. This Preferred Stock may be issued in one
or more series, the terms of which may be determined at the time of issuance by our board of directors without further action by
stockholders. The terms of any series of Preferred Stock includes voting rights and has five hundred (500) times that number of
votes on all matters submitted to the shareholders that each shareholder of Company’s Common Stock entitled to vote at each
meeting of shareholders of the Company. The issuance of any Preferred Stock could materially adversely affect the rights of the
holders of our Common Stock, and therefore, reduce the value of our Common Stock. In particular, specific rights granted to future
holders of Preferred Stock could be used to restrict our ability to merge with, or sell our assets to, a third party and thereby
preserve control by the holders of Preferred Stock.
If
a market for our Common Stock does not develop, stockholders may be unable to sell their shares.
We
intend to become a SEC reporting company and list our Common Stock on a national securities exchange or quotation system at such
time as we meet the initial listing criteria, but there is no guarantee that we will become an SEC reporting company or that our
shares will be traded or, if traded, that a public market will materialize. If our Common Stock is not traded on a national securities
exchange or quotation system or if a public market for our Common Stock does not develop, investors may not be able to re-sell
their shares of Common Stock and may lose all of their investment.
Our
management team owns a significant percentage of our stock and will be able to exercise significant influence over our affairs.
Currently, our CEO holds beneficially 52.16%
of the issued and outstanding shares of Common Stock and directly 100% of the issued and outstanding shares of the Preferred Stock.
A majority of our voting stock is able to influence the composition of our board of directors, retain the voting power to approve
all matters requiring stockholder approval and continue to have significant influence over our operations. The interests of these
stockholders may be different from the interests of other stockholders on these matters. This concentration of ownership could
also have the effect of delaying or preventing a change in our control or otherwise discouraging a potential acquirer from attempting
to obtain control of us, which in turn could reduce the value of our stock.
If
securities or industry analysts do not publish research or reports, or if they publish adverse or misleading research or reports,
regarding us, our business or our market, our stock price and trading volume could decline.
Any
trading market for our Common Stock, if we are successful in listing on an exchange or other public trading market, may be influenced
by the research and reports that securities or industry analysts publish about us, our business or our market. We do not currently
have and may never obtain research coverage by securities or industry analysts. If no or few securities or industry analysts commence
coverage of us, our stock price would be negatively impacted. In the event we obtain securities or industry analyst coverage,
if any of the analysts who cover us issue adverse or misleading research or reports regarding us, our business model, our intellectual
property, our stock performance or our market, or if our operating results fail to meet the expectations of analysts, our stock
price would likely decline. If one or more of these analysts cease coverage of us or fail to publish reports on us regularly,
we could lose visibility in the financial markets, which in turn could cause our stock price or trading volume to decline.
We
may be subject to securities litigation, which is expensive and could divert management attention.
The
market price of our Common Stock may be volatile and, in the past, 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.
We
do not currently intend to pay dividends on our Common Stock and, consequently, your ability to achieve a return on your investment
will depend on appreciation of the value of our Common Stock.
We
have never declared or paid any cash dividends on our equity securities. We currently anticipate that we will retain future earnings,
if any, for the development, operation and expansion of our business and do not anticipate declaring or paying any cash dividends
for the foreseeable future. In addition, debt instruments to which we may be party in the future may limit our ability to pay
dividends. Any return to stockholders will therefore be limited to any appreciation in the value of our Common Stock, which is
not certain.
General
Risk Factors
We
are a “smaller reporting company” and we cannot be certain if the reduced disclosure requirements applicable to smaller
reporting companies will make our securities less attractive to investors.
We
are a “smaller reporting company,” as defined in Rule 12b-2 under the Exchange Act, and we may take advantage of certain
exemptions from various reporting requirements that are applicable to other public companies, including “emerging growth
companies” such as, but not limited to, not being required to comply with the auditor attestation requirements of Section
404 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. Our status as a smaller reporting company is determined on
an annual basis. We cannot predict if investors will find our securities less attractive or our Company less comparable to certain
other public companies because we will rely on these exemptions. For example, if we do not adopt a new or revised accounting standard,
our future financial results may not be as comparable to the financial results of certain other companies in our industry that
adopted such standards.
The
requirements of being a reporting public company may strain our resources, divert management’s attention and affect our
ability to attract and retain additional executive management and qualified board members.
As
a reporting public company, we will be subject to the reporting requirements of the Exchange Act, the Sarbanes-Oxley Act, and
the Dodd-Frank Act, and other applicable securities rules and regulations. Compliance with these rules and regulations will increase
our legal and financial compliance costs, make some activities more difficult, time-consuming, or costly and increase demand on
our systems and resources, particularly after we are no longer a “smaller reporting company.” The Exchange Act requires,
among other things, that we file annual, quarterly, and current reports with respect to our business and results of operations.
As a “smaller reporting company,” we receive certain reporting exemptions under the Sarbanes-Oxley Act.
Changing
laws, regulations and standards relating to corporate governance and public disclosure create uncertainty for public companies,
increase legal and financial compliance costs and increase time expenditures for internal personnel. These laws, regulations and
standards are subject to interpretation, in many cases due to their lack of specificity, and their application in practice may
evolve over time as regulators and governing bodies provide new guidance. These changes may result in continued uncertainty regarding
compliance matters and may necessitate higher costs due to ongoing revisions to filings, disclosures and governance practices.
We intend to invest resources to comply with evolving laws, regulations and standards, and this investment may result in increased
general and administrative expenses and a diversion of management’s time and attention from revenue-generating activities
to compliance activities. If our efforts to comply with new laws, regulations and standards differ from the activities intended
by regulatory or governing bodies due to ambiguities related to their application and practice, regulatory authorities may initiate
regulatory or legal proceedings against us and our business may be adversely affected.
As
a public company under these rules and regulations, we expect that it may make it more expensive for us to obtain director and
officer liability insurance, and we may be required to accept reduced coverage or incur substantially higher costs to obtain coverage.
These factors could also make it more difficult for us to attract and retain qualified directors and officers.
If
we do not comply with the court order issued to us, we could have a risk of a litigation with the FTC.
Our operations were suspended on October
3, 2018 when the FTC filed a complaint against the Company for permanent injunctions and other equitable relief. On March 1, 2022,
the U.S. District Court for the Central District of California ordered a halt to practices used by Redwood Scientific Technologies
regarding the promotion and sale of dissolvable oral film strips as effective smoking cessation, unless the representation is
non-misleading, and relies upon competent and reliable scientific evidence including the use of human clinical testing of the
product substantiating that the representation is true. We were issued an injunction on these activities. Should we violate any
of the items issued in the injunction we could risk having new litigation with the FTC.
The Court issued a Default Judgment
Including Permanent Injunction Order as to Redwood and a Final Judgment and Order as to Redwood’s CEO which contain substantially
similar provisions. Section IV of the Injunction bars Redwood and its CEO from directly or indirectly advertising, marketing,
promoting, or offering for sale of any dissolvable oral film strips to end-user consumers. Sections V and VI restrain and enjoin
Redwood and its CEO, whether acting directly or indirectly, from making expressly or through implication, representations that
a product helps smokers quit smoking, causes weight loss, suppresses appetite, increases sexual performance or cures, mitigates
or treats any disease unless the representation is non-misleading and is, at the time of making such representation, supported
by competent, reliable and scientific evidence substantiating that the representation is true.
ITEM 2. |
FINANCIAL INFORMATION |
Management’s
Discussion and Analysis of Financial Condition and Results of Operations.
The
following discussion of our financial condition and results of operation should be read in conjunction with the financial statements
and related notes that appear elsewhere in this Registration Statement. This discussion contains forward-looking statements and
information relating to our business that reflect our current views and assumptions with respect to future events and are subject
to risks and uncertainties, including the risks in the section entitled Risk Factors beginning on page 7, that may cause our or
our industry’s actual results, levels of activity, performance or achievements to be materially different from any future
results, levels of activity, performance or achievements expressed or implied by these forward-looking statements.
These
forward-looking statements speak only as of the date of this Registration Statement. Although we believe that the expectations
reflected in the forward-looking statements are reasonable, we cannot guarantee future results, levels of activity, or achievements.
Except as required by applicable law, including the securities laws of the United States, we expressly disclaim any obligation
or undertaking to disseminate any update or revisions of any of the forward-looking statements to reflect any change in our expectations
with regard thereto or to conform these statements to actual results.
Overview
We are a pharmaceutical company committed
to the global development and commercialization of homeopathic drugs and supplements for smoking and vaping cessation. We intend
to manufacture and market sublingually delivered over the counter (“OTC”) supplements that address unmet needs in
a multi-billion-dollar market for nicotine cessation.
We are currently preparing to start
conducting clinical trials to assess safety and efficacy of TBX-FREE in smoking cessation and TBX-VAPE-FREE in vaping cessation.
Provided our clinical trials are successful, we believe our products can help many people curb their addiction to nicotine. Our
products will be centered on the innovative sublingual strip technology we have developed. We do not depend on any licenses for
our products.
We currently have a smoking cessation
product listed with the Food and Drug Administration (the “FDA”) and after development we intend to list a vaping
cessation product with the FDA. We have a successful history in nicotine replacement therapy with our FDA listed product, TBX-FREE,
which we believe is among the first FDA listed oral strip that helps smokers eliminate the craving to smoke. In addition to treating
smoking addiction, we are also focused on vaping cessation. We are in the process of developing and launching a new product, TBX-VAPE-FREE,
to assist individuals to quit vaping, which we believe will be among the world’s first-to-market product for the addiction
of nicotine in a vape device. Both of our products utilize patent-pending, sublingual strip delivery technology.
We are currently preparing to start
conducting clinical trials to assess safety and efficacy of TBX-FREE in smoking cessation and TBX-VAPE-FREE in vaping cessation.
We believe that TBX-FREE and TBX-VAPE-FREE make compelling product candidates to further evaluate in clinical trials for the treatment
of nicotine cessation. Respective clinical trials will be conducted simultaneously in a course of approximately four months. We
expect the approximate cost is $1.25 million. After, we will continue following the individuals in the clinical trials for an
additional approximately eight months to reevaluate for long term results. We have not yet submitted an Investigational New Drug
(IND) Application to the FDA in connection with the clinical trials.
Going
Concern
The accompanying audited financial statements
have been prepared assuming that the Company will continue as a going concern. The Company currently has limited liquidity and
has not completed its clinical trials of its new products will which are planned to come to the market. Additionally, the Company
had no assets as of December 31, 2022, and December 31, 2021. The Company had an accumulated deficit of $5,275,421 and $5,131,708
as of December 31, 2022, and December 31, 2021 respectively and the Company had a working capital deficit of $143,713 as of December
31, 2022, and working capital of $0 as of December 31, 2021. These factors, raises doubt about its ability to continue as a going
concern. The financial statements do not include any adjustments that may result from the outcome of these uncertainties. The Company
will require additional financing moving forward and is pursuing various strategies to accomplish this, including seeking equity
funding and/or debt funding from private placement sources. Although management believes that it will be able to obtain the necessary
funding to allow the Company to remain a going concern through the methods discussed above, there can be no assurances that such
methods will prove successful. Management anticipates that the Company will be dependent, for the near future, on additional investment
capital to fund operating expenses. There are no assurances that the Company will be successful in this or any of its endeavors
or become financially viable and continue as a going concern.
Plan
of Operation
Our initial development products are
TBX-FREE and TBX-VAPE-FREE and the commercialization of those products. We are actively engaged with introducing in the next six
to twelve months our products to significant volume national retail chains such as Walmart, Walgreens, Rite Aid and Kroger. As
we do not sell to end users, we will manufacture and deliver to distributors for sale only. To date, the Company has had only
verbal communications with the key brokers that sell into the national retail chains. We have not entered into any agreement with
any of the national retail chains as of yet, and we will wait to complete our clinical trial work prior to the next stage of these
discussions.
Our
mission is to be at the forefront of the fast-growing category of sublingual oral strips as a method of delivering medication,
homeopathic therapy, and other health and wellness products to the consumer.
With this mission in mind, we envision
our Company becoming the industry leader in sublingual strip delivery technology, for smoking and vaping cessation products. We
will strive to command the largest share of the market while maintaining our price premium through continued research and development
of health and wellness products that can be delivered through the sublingual strip delivery technology.
Critical
Accounting Policies and Estimates
The following discussion and analysis of financial condition and results of operations is based upon our
financial statements, which have been prepared in conformity with accounting principles generally accepted in the United States
of America. Certain accounting policies and estimates are particularly important to the understanding of our financial position
and results of operations and require the application of significant judgment by our management or can be materially affected by
changes from period to period in economic factors or conditions that are outside of our control. As a result, they are subject
to an inherent degree of uncertainty. In applying these policies, our management uses their judgment to determine the appropriate
assumptions to be used in the determination of certain estimates. Those estimates are based on our historical operations, our future
business plans and projected financial results, our observance of trends in the industry and information available from other outside
sources, as appropriate. Please see Note 3 to our financial statements for a more complete description of our significant accounting
policies.
Upon
the filing of our initial registration statement, we intend to utilize the extended transition period provided in Securities
Act of 1933 (the “Securities Act”) Section 7(a)(2)(B) as allowed by Section 107(b)(1) of the JOBS Act for the
adoption of new or revised accounting standards as applicable to emerging growth companies. As part of the election, we will not
be required to comply with any new or revised financial accounting standard until such time that a company that does not qualify
as an “issuer” (as defined under Section 2(a) of the Sarbanes-Oxley Act of 2002) is required to comply with such new
or revised accounting standards.
As
an emerging growth company within the meaning of the rules under the Securities Act, we will utilize certain exemptions from various
reporting requirements that are applicable to public companies that are not emerging growth companies. For example, we will not
have to provide an auditor’s attestation report on our internal controls in future annual reports on Form 10-K as otherwise
required by Section 404(b) of the Sarbanes-Oxley Act. In addition, Section 107 of the JOBS Act provides that an emerging growth
company can utilize the extended transition period provided in Section 7(a)(2)(B) of the Securities Act for complying with new
or revised accounting standards. Thus, an emerging growth company can delay the adoption of certain accounting standards until
those standards would otherwise apply to private companies. We have elected to utilize this extended transition period. Our financial
statements may therefore not be comparable to those of companies that comply with such new or revised accounting standards as
they become applicable to public companies.
Basis
of Presentation
The Company’s financial statements have been prepared in conformity with accounting principles generally
accepted in the United States which contemplate continuation of the Company as a going concern. However, the Company is subject
to the risks and uncertainties associated with a new business, has no established source of revenue, and has incurred significant
losses from operations since inception. The Company’s operations are dependent upon it raising additional capital. These
matters raise substantial doubt about the Company’s ability to continue as a going concern. The financial statements do not
include any adjustments relating to the recoverability and classification of recorded asset amounts or the amounts and classification
of liabilities that could result from the outcome of this uncertainty.
Research
and Development
Research and development costs consist
of expenditures incurred during the course of planned research and investigation aimed at the discovery of new knowledge, which
will be useful in developing new products or processes. The Company expenses all research and development costs as incurred. The
Company does not believe any clinical trial activities meet the criteria for reporting such amounts as research and development
expenses under Account Standards Codification (“ASC”) 730.
Results of Operations
The Three Months Ended June 30, 2023 to the Three
Months Ended June 30, 2022
Operating Expenses. Our operating expenses totaled
$315,998 during the three months ended June 30, 2023 and consisted of accounts payable and accrued expenses. The Company was in
a receivership during the three months ended in 2022 and did not have any revenue or expenses.
Net Loss. As there were no revenue in the period,
the net loss was $315,998 during the three months ended June 30, 2023. The Company was in a receivership during the three months
ended in 2022 and did not have any revenue or expenses.
The Six Months Ended June 30, 2023 to the Three Months
Ended June 30, 2022
Operating Expenses. Our operating expenses totaled
$527,683 during the six months ended June 30, 2023 and consisted of accounts payable and accrued expenses. The Company was in
a receivership during the six months ended in 2022 and did not have any revenue or expenses.
Net Loss. As there were no revenue in the period,
the net loss was $527,683 during the six months ended June 30, 2023. The Company was in a receivership during the six months ended
in 2022 and did not have any revenue or expenses.
The Year Ended December 31, 2022
Operating Expenses. Our operating expenses totaled $143,713
and consisted of accounts payable and accrued expenses.
Net Loss. As there were no revenue in the period, the
net loss was $143,713.
The Year Ended December 31, 2021
The Company was in a receivership in 2021 and did not have any revenue or expenses.
Liquidity
and Capital Resources
We incurred net losses of $143,713 during
the year ended December 31, 2022. We are a development stage company and have generated losses from operations since year 2022.
These losses have been from legal expenses and general and administrative fees. In order to execute our long-term strategic plan
to develop and commercialize our core products, we will need to raise additional funds, through public or private equity offerings,
debt financings, or other means. These conditions raise substantial doubt about our ability to continue as a going concern.
Subsequent to the period ended
December 31, 2022, we sold 11,400,000 shares at $0.10 per share of Common Stock and warrants exercisable at $0.15 per warrant
resulting in proceeds of $1,140,000 in a private placement.
Through March 31, 2023, we raised $696,650
in private placement proceeds.
During the three months ended March
31, 2023, we issued 4,000,000 shares of Common Stock for legal services, 150,000 shares of Common Stock for accounting services,
and 7,500,000 shares of Common Stock for consulting services.
We anticipate the need to raise a net amount
of approximately $9,500,000 of which $3,000,000 is allocated to product development, $5,000,000 to sales and marketing and $1,500,000
for general administrative and corporate purposes.
We can give no assurance that our cash on hand or the additional
cash raised will be sufficient to achieve our business plan or that additional financing will be available on reasonable terms,
or available at all, or that it will generate sufficient revenue to alleviate the going concern. Should we be unsuccessful in obtaining
the necessary financing, or generate sufficient revenue to fund our operations, we would need to curtail our operational activities.
Off
Balance Sheet Arrangements
We
have no off-balance sheet arrangements.
We have a mailing address located
at 418 Broadway, STE 4872, Albany, NY 12207.
ITEM 4. |
SECURITY OWNERSHIP OF CERTAIN BENEFICIAL OWNERS AND MANAGEMENT |
The following table sets forth information
regarding beneficial ownership of our Common Stock as of August 21, 2023 by:
● | each person whom we know to beneficially own more than 5% of our Common Stock; |
● | each of our directors; |
● | each of our named executive officers; and |
● | all directors and executive officers as a group. |
In accordance with the rules of the
SEC, beneficial ownership includes voting or investment power with respect to securities and includes the shares issuable pursuant
to stock options and warrants that are exercisable within 60 days of August 21, 2023. Shares issuable pursuant to stock options
and warrants are deemed outstanding for computing the percentage of the person holding such options but are not outstanding for
computing the percentage of any other person.
We have based our calculation of the
percentage of beneficial ownership on 201,877,134 shares of our Common Stock outstanding and held of record by approximately 485
stockholders as of August 21, 2023.
Unless otherwise indicated, the address for each listed stockholder is c/o Redwood Scientific Technologies,
Inc., 418 Broadway, STE 4872, Albany, NY 12207. To our knowledge, except as indicated in the footnotes to this table and pursuant
to applicable community property laws, the persons named in the table have sole voting and investment power with respect to all
shares of Common Stock.
Name of Beneficial Owner |
Number of Shares of Common Stock Beneficially Owned |
Percentage of Class |
Number of Shares of Preferred Stock Beneficially Owned |
Percentage of Class |
|||||||
Named Executive Officers and Directors: |
|||||||||||
Jason Cardiff (1) | 105,302,459 | (1) | 52.16 | % | 2,500,000 | (2) | 100 | % | |||
David Duncan | 150,000 | 0.07 | % | 0 | 0 | % | |||||
John Harrington | 350,000 | 0.17 | % | 0 | 0 | % | |||||
Brian Kennedy | 2,000,000 | 0.99 | % | 0 | 0 | % | |||||
Christine Hayes |
814,600 | 0.40 | % | 0 | 0 | % | |||||
All executive officers and directors as a group (5 persons) |
108,617,059 | 53.80 | % | 2,500,000 | 100 | % | |||||
All Other Greater than 5% Owners: | |||||||||||
None. |
*
Less than 1%.
(1) 105,302,459 shares of Common Stock
held in Carols Place Limited Partnership. Jason Cardiff, our chairman and CEO, and Eunjung Cardiff, who is Mr. Cardiff’s
wife, are the limited partners of Carols Place Limited Partnership, and Extension First, LLC, a Wyoming limited liability company
is the general partner of Carols Place Limited Partnership. Jason Cardiff and Eunjung Cardiff are the members of Extension First,
LLC.
(2) Jason Cardiff, our chairman and the
CEO, holds 2,500,000 shares of Preferred Stock, representing 100% of the issued and outstanding shares of Preferred Stock.
ITEM 5. |
DIRECTORS AND EXECUTIVE OFFICERS |
The following sets forth information regarding our executive officers and the members of our board of
directors as of the date of this Registration Statement. All directors hold office for one-year terms until the election and qualification
of their successors. Officers are appointed by our board of directors and serve at the discretion of our board of directors.
Name | Age | Position(s) | ||
Jason Cardiff | 48 | Chief Executive Officer and President and Director |
||
John Harrington | 64 | Chief Financial Officer | ||
David Duncan | 51 | Chief Operating Officer | ||
Brian Kennedy | 61 | Director | ||
Christine Hayes | 71 | Director |
Jason Cardiff, President, Chief Executive
Officer, Director: Since 2013, Mr. Cardiff has served as CEO of the Company. Prior to Redwood, Mr. Cardiff founded First
Choice Media, a private consulting company that ran marketing and placed all forms of media for national not-for-profit organizations
while simultaneously finding success with his own national infomercial businesses and products. Mr. Cardiff was a Founder of VPL Medical,
a company dedicated to manufacturing 3-ply face masks in the United States. Mr. Cardiff’s activities are subject to a Final Injunction
issued by the District Court in FTC v. Redwood Scientific Technologies, Inc., 5:18-cv-02104-DMG-PLA. The injunction is substantially
identical to the injunction against Redwood. The Company believes Mr. Cardiff’s knowledge
of the Company and its industry gives him the qualifications and skills to serve as a Director.
John
Harrington, Chief Financial Officer. Mr. Harrington is the principal at Franklin Management, an outsourced accounting
and business consulting firm, since 2002. Previously Mr. Harrington had several financial management roles in both public and
private companies. He is a graduate of Northeastern University and has an MBA from Babson College.
David
Duncan, Chief Operating Officer. David Duncan founded HOTB Software, Inc. in 2008 and he was the President of HOBT Software,
Inc. until 2012, Chief Procurement Officer 2013-2016, Vice President 2016-2019 and currently a Director. HOTB Software, Inc. developed
software that dispersed over $6 billion from US Treasury to multiple state housing agencies, hundreds of nonprofit housing outfits,
and tens of thousands of troubled homeowners. Mr. Duncan has spent more than two-decades in direct response marketing. Mr.
Duncan studied Philosophy at the University of California at Berkeley.
Brian Kennedy, Director. Mr. Kennedy
is President of the American Strategy Group, a public policy think tank. Mr. Kennedy started at the American Strategy Group in 2015.
Mr. Kennedy also serves a board member and senior fellow of the Claremont Institute. Mr. Kennedy is the chairman of the Committee on
the Present Danger: China, founded in March of 2019 and is a member of the Independent Working Group on Missile Defense. Mr. Kennedy
is the author of Communist China’s War Inside America by Encounter Books (June 2020). The
Company believes Mr. Kennedy’s experience in public policy gives him the qualifications and skills to serve as a Director.
Christine Hayes, Director. Christine
Hayes has worked for the past 20 years in the real estate industry and is the founder of Rosemont Mortgage (founded in 1992) and Melrose
Escrow, Inc. (founded in 1994). Ms. Hayes has a great degree of knowledge in complex financial transactions and complex regulatory bodies
and corporate governance. The Company believes Ms. Hayes’ experience founding two successful
companies gives her the qualifications and skills to serve as a Director.
Family
Relationships
There
are no family relationships among any of our current executive officers or directors.
ITEM 6. |
EXECUTIVE COMPENSATION |
Executive
Officers
We currently have no employment agreements
with any of our officers and directors other than an employment agreement with our COO. See “Item 7. Certain Relationships
and Related Transactions, and Director Independence” for additional information.
No compensation was paid, distributed
or accrued by us for the years ended December 31, 2022 and 2021 as the Company was in a receivership from March 2018 to January
2023 and it did not have any executive officers during that time.
As of August 21, 2023, there were no
outstanding equity awards to any of our executive officers or our directors.
ITEM 7. |
CERTAIN RELATIONSHIPS AND RELATED TRANSACTIONS, AND DIRECTOR INDEPENDENCE |
Corporate
Governance and Director Independence
Presently,
we are not currently listed on a national securities exchange or in an inter-dealer quotation system and therefore are not
required to comply with the director independence requirements of any securities exchange. In determining whether our
directors are independent, however, we intend to comply with the rules of Nasdaq. The board of directors will also
consult with counsel to ensure that the board of director’s determinations are consistent with those rules and all
relevant securities and other laws and regulations regarding the independence of directors, including those adopted under the
Sarbanes-Oxley Act of 2002 with respect to the independence of audit committee members. Nasdaq Listing Rule 5605(a)(2)
defines an “independent director” generally as a person other than an Executive Officer or employee of the
Company or any other individual having a relationship which, in the opinion of the Company’s board of directors, would
interfere with the exercise of independent judgment in carrying out the responsibilities of a director. Our board of
directors has determined that two of the directors would qualify as “independent” as that term is defined by
Nasdaq Listing Rule 5605(a)(2). Finally, we have determined that Brian Kennedy and
Christine Hayes qualifies as “independent” under Nasdaq Listing Rules applicable to committees of the
board of directors.
Due to our lack of operations and current size, we do not have an audit committee or any other separate
committees. The board of directors will consider appointing members to each of the Committees at such time as a sufficient number
of independent directors are appointed to the board of directors or as otherwise determined by the board of directors. Until such
time, the full board of directors will undertake the duties of the audit committee, compensation committee and nominating committee.
Since
the past two fiscal years, there have been no transactions, whether directly or indirectly, between us and any of the Company’s
officers, directors, beneficial owners of more than 5% of outstanding shares of Common Stock or outstanding shares of a class
of voting Preferred Stock, or their family members, that exceeded the lesser of (i) $120,000 or (ii) one percent (1%) of the average
of the Company’s total assets at year-end for the last two fiscal years, and in which any of our directors, executive officers
or beneficial holders of more than 5% of any class of our capital stock, or any immediate family member of, or person sharing
the household with, any of these individuals, had or will have a direct or indirect material interest.
We are currently not a party to any
material legal or administrative proceedings and are not aware of any pending legal or administrative proceedings against us.
We may from time to time become a party to various legal or administrative proceedings arising in the ordinary course of our business.
The Company is not currently subject to or aware of any pending material legal proceedings.
ITEM 9. |
MARKET PRICE OF AND DIVIDENDS ON THE REGISTRANT’S COMMON EQUITY AND RELATED STOCKHOLDER MATTERS |
Market
Information
We have no established public trading
market. Our common stock is quoted on the OTC Pink Market under the symbol “RSCI”. The bid quotations reported on
the OTC Pink Market reflect inter-dealer prices without retail markup, markdown or commissions, and may not necessarily represent
actual transactions.
Our common stock is very sporadically
traded. The quoted bid and ask prices for our common stock vary from week to week. An investor holding shares of our common stock
may find it difficult to sell the shares and may find it impossible to sell more than a small number of shares at the quoted bid
price.
The highest and lowest bid during past
two fiscal years and in the first two quarters in 2023 are as follows
2021
High | Low | |
Q1 | $0.220 | $0.016 |
Q2 | $0.160 | $0.011 |
Q3 | $0.100 | $0.010 |
Q4 | $0.012 | $0.003 |
2022
High | Low | |
Q1 | $0.003 | $0.003 |
Q2 | $0.004 | $0.003 |
Q3 | $0.004 | $0.003 |
Q4 | $0.006 | $0.0002 |
2023
High | Low | |
Q1 | $0.110 | $0.006 |
Q2 | $0.19 | $0.072 |
Holders
As of August 21, 2023, we had 201,877,134
shares of Common Stock outstanding, held of record by 485 stockholders and 2,500,000 shares of Preferred Stock held by one holder.
Dividends
Subject
to preferences that may be applicable to any then outstanding Preferred Stock, holders of our Common Stock are entitled to receive
dividends as may be declared from time to time by our board of directors out of legally available funds. However, we have never
paid cash dividends on any of our capital stock and we currently intend to retain our future earnings, if any, to fund the development
and growth of our business. We do not intend to pay cash dividends to holders of our Common Stock in the foreseeable future.
Securities
Authorized for Issuance under Equity Compensation Plans
The
Company currently has no compensation plans under which the Company’s securities are authorized for issuance.
ITEM 10. |
RECENT SALES OF UNREGISTERED SECURITIES |
We recently
concluded a funding round in which each investor purchased shares at the purchase price of $0.10 per a share of Common Stock and warrant,
with warrants convertible at an exercise price equal to $0.15 per warrant. We also issued shares of Common Stock to employees and consultants
for work performed on behalf of Redwood. Please see Note 7 to our financial statements for a more complete description of our recent
sale of unregistered securities.
None of the foregoing transactions
involved any underwriters, underwriting discounts or commissions, or any public offering. The sales of the above securities were
deemed to be exempt from registration under the Securities Act in reliance on Section 4(a)(2) of the Securities Act (and Regulation
D or Regulation S promulgated thereunder) or Rule 701 promulgated under Section 3(b) of the Securities Act as transactions by
an issuer not involving any public offering or pursuant to benefit plans and contracts relating to compensation as provided under
Rule 701. The recipients of the securities in each of these transactions represented their intentions to acquire the securities
for investment only and not with a view to or for sale in connection with any distribution thereof, and appropriate legends were
placed on the share certificates issued in these transactions. All recipients had adequate access, through their relationships
with us, to information about us. The sales of these securities were made without any general solicitation or advertising.
ITEM 11. |
DESCRIPTION OF REGISTRANT’S SECURITIES TO BE REGISTERED |
Pursuant to our Certificate of Incorporation,
we are authorized to issue 495,000,000 shares of Common Stock, $0.001 par value per share and 5,000,000 shares of Preferred Stock,
par value $0.001 per share. As of the date of this Registration Statement, we have 201,877,134 shares of Common Stock issued and
outstanding and 485 stockholders of record and 2,500,000 shares of Preferred Stock issued and outstanding and one holder of record.
The
following description of our capital stock and provisions of our articles of incorporation and bylaws are summaries and are qualified
by reference to the articles of incorporation and bylaws.
Common
Stock
Holders
of Common Stock are entitled to cast one vote for each share on all matters submitted to a vote of stockholders. At each election
for directors every shareholder entitled to vote at such election shall have the right to vote, in person or by proxy, the number
of shares owned by him for as many persons as there are directors to be elected at that time and for whose election he has a right
to vote; candidates receiving the highest number of votes up to the number of directors to be elected shall be elected. The holders
of Common Stock are entitled to receive ratably such dividends, if any, as may be declared by the board of directors out of funds
legally available therefore. Such holders do not have any preemptive or other rights to subscribe for additional shares. All holders
of Common Stock are entitled to share ratably in any assets for distribution to stockholders upon the liquidation, dissolution
or winding up of the Company. There are no conversion, redemption or sinking fund provisions applicable to the Common Stock. All
outstanding shares of Common Stock are fully paid and non-assessable.
Preferred
Stock
The
board of directors is authorized, without further action by the stockholders, to issue, from time to time, up to 5,000,000 shares
of Preferred Stock all of which is designated as Series A Super Voting Preferred Shares. Similarly, as of the date of this filing,
we have issued 2,500,000 shares of Preferred Stock and 100% of it is beneficially held by Jason Cardiff.
Holders of the Series A Super Voting Preferred Shares shall have five hundred (500) times that number
of votes on all matters submitted to the shareholders that each shareholder of the Common Stock (rounded to the nearest whole number)
is entitled to vote at each meeting of shareholders of the Company (and written actions of shareholders in lieu of meetings) with
respect to any and all matters presented to the shareholders of the Company for their action or consideration. Holders of the Series
A Super Voting Preferred Shares shall vote together with the holders of Common Stock as a single class. Holders of Series A Super
Voting Preferred Shares shall not be entitled to receive dividends paid on the Company’s Common Stock. Dividends paid to
holders of the Series A Super Voting Preferred Shares, if any, shall be at the discretion of the board of directors. Upon the liquidation,
dissolution and winding up of the Company, whether voluntary or involuntary, holders of the Series A Super Voting Preferred Shares
shall not be entitled to receive any of the assets of the Company. The shares of Series A Super Voting Preferred Shares shall not
be convertible into shares of the Company’s Common Stock. The affirmative vote at a meeting duly called for such purpose,
or the written consent without a meeting, of the holders of not less than fifty-one percent (51%) of the then-outstanding shares
of Series A Super Voting Preferred Shares shall be required for (a) any change to the Company’s Articles of Incorporation
that would amend, alter, change or repeal any of the preferences, limitations or relative rights of the Series A Super Voting Preferred
Shares or (b) any issuance of additional shares of Series A Super Voting Preferred Shares.
The
board of director’s authority to issue preferred stock also provides a convenient vehicle in connection with possible acquisitions
and other corporate purposes, but could have the effect of making it more difficult for a third party to acquire a majority of
our outstanding voting stock. Accordingly, the issuance of preferred stock may be used as an “anti-takeover” device
without further action on the part of our stockholders, and may adversely affect the holders of the Common Stock.
ITEM 12. |
INDEMNIFICATION OF DIRECTORS AND OFFICERS |
Our Certificate of Incorporation provides
that no director of the Company shall be liable to the Company or its stockholders for monetary damages for breach of fiduciary
duty as a director, except for liability (i) for any breach of the director’s duty of loyalty to the Company or its stockholders,
(ii) for acts or omissions not in good faith or that involve intentional misconduct or a knowing violation of law, (iii) under
Section 174 of the Delaware General Corporation Law (“DGCL”) or (iv) for any transaction from which the director derived
an improper personal benefit. The Corporation shall indemnify and shall advance expenses on behalf of its officers and directors
to the fullest extent permitted by law. It is the intent that this provision be interpreted to provide the maximum protection
against liability afforded to directors under the DGCL in existence either now or hereafter.
Under the DGCL, our directors have
a fiduciary duty to us that is not eliminated by this provision of the restated certificate of incorporation and, in appropriate
circumstances, equitable remedies such as injunctive or other forms of non-monetary relief will remain available. This provision
also does not affect our directors’ responsibilities under any other laws, such as federal securities laws or state or federal
environmental laws.
Section 145 of the DGCL empowers
a corporation to indemnify its directors and officers against expenses (including attorneys’ fees), judgments, fines and
amounts paid in settlements actually and reasonably incurred by them in connection with any action, suit or proceeding brought
by third parties by reason of the fact that they were or are directors or officers of the corporation, if they acted in good faith,
in a manner they reasonably believed to be in or not opposed to the best interests of the corporation and, with respect to any
criminal action or proceeding, had no reasonable cause to believe that their conduct was unlawful. The DGCL provides further that
the indemnification permitted thereunder shall not be deemed exclusive of any other rights to which the directors and officers
may be entitled under the corporation’s bylaws, any agreement, a vote of stockholders or otherwise. Our restated certificate
of incorporation provides that, to the fullest extent permitted by Section 145 of the DGCL, we shall indemnify any person
who is or was a director or officer of us, or is or was serving at our request as a director, officer or trustee of another corporation,
partnership, joint venture, trust, employee benefit plan or other enterprise, against the expenses, liabilities or other matters
referred to in or covered by Section 145 of the DGCL. Our amended and restated bylaws provide that we will indemnify any
person who was or is a party or threatened to be made a party to any proceeding by reason of the fact that such person is or was
a director or officer of us or is or was serving at our request as a director, officer or trustee of another corporation, partnership,
joint venture, trust, employee benefit plan or other enterprise to the fullest extent permitted by the DGCL.
Insofar
as indemnification for liabilities arising under the Securities Act of 1933 may be permitted to directors, officers or persons
controlling the registrant, pursuant to the foregoing provisions, the Registrant has been informed that in the opinion of the
Securities and Exchange Commission such indemnification is against public policy as expressed in the Securities Act of 1933 and
is, therefore, unenforceable.
We
intend to enter into indemnity agreements with each of our officers and directors, a form of which is filed as Exhibit 10.1
to this Registration Statement. These agreements will require us to indemnify these individuals to the fullest extent permitted
under Delaware law and to advance expenses incurred as a result of any proceeding against them as to which they could be indemnified.
ITEM 13. |
FINANCIAL STATEMENTS AND SUPPLEMENTARY DATA |
Set
forth below is an index to our financial statements attached to this Registration Statement.
ITEM 14. |
CHANGES IN AND DISAGREEMENTS WITH ACCOUNTANTS ON ACCOUNTING AND FINANCIAL DISCLOSURE |
None.
ITEM 15. |
FINANCIAL STATEMENTS AND EXHIBITS |
(a) | The financial statements attached to this Registration Statement are listed under “Item 13. Financial Statements and Supplementary Data.” |
Exhibit
Index
* Previously Filed
** Filed Herewith
*** To be filed by Amendment
SIGNATURES
Pursuant
to the requirements of Section 12 of the Securities Exchange Act of 1934, the registrant has duly caused this Registration Statement
to be signed on its behalf by the undersigned, thereunto duly authorized.
By: | /s/ Jason Cardiff |
||
Name: | Jason Cardiff |
||
Title: | Chief Executive Officer, President and Director |
Date: August 23, 2023
REDWOOD
SCIENTIFIC TECHNOLOGIES, INC.
FINANCIAL
STATEMENTS
TABLE
OF CONTENTS
REPORT
OF INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRM
To:
The Shareholders and the Board of Directors of
Redwood
Scientific Technologies, Inc.
Opinion
on the Financial Statements
We
have audited the accompanying financial statements of Redwood Scientific Technologies, Inc. (“the Company”), which
comprise the balance sheet as of December 31, 2022 and December 31, 2021, and the related statements of income, changes in stockholders’
deficit, and cash flows for the years ended December 31, 2022 and December 31, 2021, and the related notes to the financial statements
(collectively referred to as the “financial statements”).
In
our opinion, the accompanying financial statements present fairly, in all material respects, the financial position of
Redwood Scientific Technologies, Inc. as of December 31, 2022 and December 31, 2021, and the results of its operations and
its cash flows for the years ended December 31, 2022 and December 31, 2021 in accordance with accounting principles generally
accepted in the United States of America.
Substantial
doubt about the Company’s ability to continue as a Going concern
The
accompanying financial statements have been prepared assuming the Company will continue as a going concern. As discussed in Note
4 – Going Concern to the financial statements, the Company has no assets and has not completed its efforts to generate sufficient
revenue to cover operating expenses. These factors raise substantial doubt about the Company’s ability to continue as a
going concern. Management’s plan in regards to these matters are also described in Note 4 to the financial statements. The
financial statements do not include any adjustments that might result from the outcome of this uncertainty. Our opinion is not
modified with respect to this matter.
Basis
for Opinion
These
financial statements are the responsibility of the Company’s management. Our responsibility is to express an opinion on the Company’s
financial statements based on our audits. We are a public accounting firm registered with the Public Company Accounting Oversight
Board (United States) (“PCAOB”) and are required to be independent with respect to the Company in accordance with the
U.S. federal securities laws and the applicable rules and regulations of the Securities and Exchange Commission and the PCAOB.
We
conducted our audits in accordance with the standards of the PCAOB. Those standards require that we plan and perform the audits
to obtain reasonable assurance about whether the financial statements are free of material misstatement, whether due to error
or fraud. The Company is not required to have, nor were we engaged to perform, an audit of its internal control over financial
reporting. As part of our audits, we are required to obtain an understanding of internal control over financial reporting but
not for the purpose of expressing an opinion on the effectiveness of the Company’s internal control over financial reporting.
Accordingly, we express no such opinion.
Our
audits included performing procedures to assess the risks of material misstatement of the financial statements, whether due to
error or fraud, and performing procedures that respond to those risks. Such procedures included examining, on a test basis, evidence
regarding the amounts and disclosures in the financial statements. Our audits also included evaluating the accounting principles
used and significant estimates made by management, as well as evaluating the overall presentation of the financial statements.
We believe that our audits provide a reasonable basis for our opinion.
Emphasis
of a Matter
As
discussed in Note 2 – Effect of Receivership to the financial statements, the Company has just emerged from receivership
with the Federal Trade Commission, has no assets, been released from all liabilities that existed as of December 31, 2022, and
is in the process of re-organization. Details of the Receivership, its effects and outcome is included in Note 2 to the financial
statements. Further as discussed in Note 7 – Subsequent Events to the financial statements, as part of its re-organization,
the Company has entered into significant equity transactions between the date of the latest financial statements, December 31,
2022, and date of this report.
Critical
Audit Matters
A
critical audit matter is any matter arising from the audit of the financial statements that was communicated or required to be
communicated to the audit committee and that: (1) relates to accounts or disclosures that are material to the financial statements
and (2) involved especially challenging, subjective, or complex auditor judgment. We determined that there are no critical audit
matters.
Victor
Mokuolu, CPA PLLC
We
have served as the Company’s auditor since 2023.
Houston,
Texas
June 5, 2023
PCAOB
ID: 6771
REDWOOD SCIENTIFIC TECHNOLOGIES, INC.
For the Year Ended December 31, | ||||||||
2022 | 2021 | |||||||
Assets: | ||||||||
Current Assets | 0 | 0 | ||||||
Accounts Receivable | 0 | 0 | ||||||
Other current assets | 0 | 0 | ||||||
Prepaid Expenses | 0 | 0 | ||||||
Total current assets | 0 | 0 | ||||||
TOTAL ASSETS | 0 | 0 | ||||||
Liabilities and Stockholder’s Deficit: | ||||||||
Current Liabilities: | ||||||||
Accounts payable & accruals | 143,713 | 0 | ||||||
Total Current liabilities | 143,713 | 0 | ||||||
TOTAL LIABILITIES | 143,713 | 0 | ||||||
Stockholders’ Deficit: | ||||||||
Common Stock | 177,927 | 177,927 | ||||||
Preferred Stock | ||||||||
Additional Paid-in-capital | 4,953,781 | 4,953,781 | ||||||
Accumulated Deficit | (5,275,421 | ) | (5,131,708 | ) | ||||
TOTAL STOCKHOLDERS’ DEFICIT | (143,712 | ) | 0 | |||||
TOTAL LIABILITIES AND STOCKHOLDERS’ DEFICIT | 0 | 0 |
REDWOOD SCIENTIFIC TECHNOLOGIES, INC.
For the Year Ended December 31, | ||||||||
2022 | 2021 | |||||||
INCOME: | ||||||||
Income | 0 | 0 | ||||||
Total ordinary income/expense | 0 | 0 | ||||||
EXPENSES: | ||||||||
Operating Expenses: | ||||||||
General & Administrative | 143,713 | 0 | ||||||
Total Operating Expenses | 143,713 | 0 | ||||||
Loss from operations | (143,713 | ) | 0 | |||||
Other income (expenses): | ||||||||
Income taxes | ||||||||
Penalties | ||||||||
State Tax | 0 | |||||||
Total other income (expenses) | 0 | 0 | ||||||
Net Loss | (143,713 | ) | 0 | |||||
Net loss per share | $ | (0.00 | ) | $ | 0.00 | |||
Weighted average shares outstanding | 177,927,134 | 177,927,134 | ||||||
REDWOOD SCIENTIFIC TECHNOLOGIES, INC.
Statements Of Changes In Stockholders’ Deficit
Additional | ||||||||||||||||||||
Common Stock |
Paid-In | Accumulated | Stockholders’ | |||||||||||||||||
Shares | Par Value |
Capital | Deficit | Deficiency | ||||||||||||||||
Net Loss |
0 | 0 | 0 | (49,304 | ) | (49,304 | ) | |||||||||||||
Balance as of December 31, 2020 |
177,927,134 | 177,927 | 4,953,781 | (5,131,708 | ) | 0 | ||||||||||||||
Balance as of January 1, 2021 |
177,927,134 | 177,927 | 4,953,781 | (5,131,708 | ) | 0 | ||||||||||||||
Additions in the Year |
0 | 0 | 0 | 0 | 0 | |||||||||||||||
Adjustment of year | 0 | 0 | 0 | 0 | 0 | |||||||||||||||
Net Loss/Surplus |
0 | 0 | 0 | 0 | 0 | |||||||||||||||
Balance as of December 31, 2021 |
177,927,134 | 177,927 | 4,953,781 | (5,131,708 | ) | 0 | ||||||||||||||
Balance as of January 1, 2022 |
177,927,134 | 177,927 | 4,953,781 | (5,131,708 | ) | 0 | ||||||||||||||
Additions in the Year |
0 | 0 | 0 | 0 | 0 | |||||||||||||||
Net Loss |
0 | 0 | 0 | (143,713 | ) | (143,713 | ) | |||||||||||||
Balance as of December 31, 2022 |
177,927,134 | 177,927 | 4,953,781 | (5,275,421 | ) | (143,712 | ) |
REDWOOD SCIENTIFIC TECHNOLOGIES, INC.
For the Year Ended December 31, | ||||||||
2022 | 2021 | |||||||
Cash flows from operating activities: | ||||||||
Net loss | (143,713 | ) | – | |||||
Adjustments to reconcile net loss to net cash used in operating activities: | ||||||||
Depreciation expense | – | – | ||||||
Warrants issued for services | – | – | ||||||
Options issued for services | – | – | ||||||
Warrants forfeited in conjunction with compensation – related parties | – | – | ||||||
Other current assets | – | – | ||||||
Accounts payable and accrued expenses | 143,713 | – | ||||||
Other current liabilities | – | – | ||||||
Net cash used in operating activities | – | – | ||||||
Cash flows from investing activities: | ||||||||
None | – | – | ||||||
Net cash used in investing activities | – | – | ||||||
Cash flows from financing activities: | ||||||||
None | – | |||||||
Net cash provided by financing activities | – | – | ||||||
Net (decrease) increase in cash | – | – | ||||||
Cash at beginning of period | – | |||||||
Cash at end of period | – | – | ||||||
Supplemental disclosures of cash flow information: | ||||||||
Non-cash investing and financing activities: | ||||||||
Adjustments to Stockholders’ deficit | – |
Redwood
Scientific Technologies, Inc.
For
the two years ended December 31, 2022
NOTE
1. FORMATION AND BUSINESS OF THE COMPANY
Business
description
Redwood
Scientific Technologies, Inc. (“Redwood”, “RSCI”, or the “Company”) is a pharmaceutical company
that develops, operates, and markets innovative over-the-counter United States Food and Drug Administration (“FDA”)
registered drugs in a sublingual oral thin film strip. The Company has announced that it is starting the beginning phases of research
for clinical trials on two new products that will be marketed to help stop the addiction to nicotine.
The
Company was inactive during the time period covered by this Report due to recently concluded litigation with the Federal Trade
Commission (“FTC”).
NOTE
2. EFFECT OF RECEIVERSHIP
The
company emerged from receivership in March of 2022. All assets and liabilities prior to emergence had been liquidated. As such
the company started with a blank set of financials.
The Company was in a court ordered
Receivership during “FTC v. Redwood Scientific Technologies, Inc., Case. No. 5:18-02104 (C.D. Cal.)”, filed on October
3, 2018. The case was decided and the Company was released from the Receivership, effective March 1, 2022. Under the Court’s
practice, a Receivership is, for all intents treated as a bankruptcy for the purpose of debts and liabilities.
The
Receiver did not report any liabilities on Redwood’s books and records. It should be noted that the Court authorized the
destruction of Redwood’s books and records in its Order Approving the Receiver’s Final Report and Accounting, and
the Receiver’s Final Fee Application. Dkt. 716.
All debts and liabilities due from
and owed by Redwood Scientific Technologies, Inc. were released as of the termination of the Receivership and did not survive
the receivership. Accordingly, the debts and liabilities have been extinguished as of the year ended December 31, 2022 and December
31, 2021. In addition, the trial court held that no monetary remedies would be allowed against Redwood and other defendants. Moreover,
any claim that might have been made by the FTC is barred by the three-year statute of limitations applicable to this case effective
October 3, 2022. The Company began incurring liabilities in November 2022.
NOTE
3. SIGNIFICANT ACCOUNTING POLICIES
Uses
of estimates
The
preparation of financial statements in conformity with generally accepted accounting principles accepted in the United States
of America (“GAAP”) requires management to make estimates and assumptions that affect the reported amounts of assets
and liabilities and disclosure of contingent assets and liabilities at the date of the consolidated financial statements and the
reported amounts of net revenue and expenses during each reporting period. Actual results could differ from those estimates.
Cash
The
Company considers all short-term highly liquid investments with an original maturity date of purchase of three months or less
to be cash equivalents.
Revenue
Recognition
The
Company did not have any revenues from continuing operations for the periods presented. The Company recognizes revenue based on
Account Standards Codification (“ASC”) 606, Revenue from Contracts with Customers and all of the related amendments,
and the Company’s policy is revenues will be recognized when control of the products are transferred to our distributors.
Financial
Instruments
As
defined in Financial Accounting Standards Board ASC 820 (“FASB ASC 820”), fair value is the price that would be received
to sell an asset or paid to transfer a liability in an orderly transaction between market participants at the measurement date
(exit price). The Company will utilize the market data of similar entities in its industry or assumptions that market participants
would use in pricing the asset or liability, including assumptions about risk and the risks inherent in the inputs to the valuation
technique. These inputs can be readily observable, market corroborated, or generally unobservable. The Company classifies fair
value balances based on the observability of those inputs. FASB ASC 820 establishes a fair value hierarchy that prioritizes the
inputs used to measure fair value. The hierarchy gives the highest priority to unadjusted quoted prices in active markets for
identical assets or liabilities (level 1 measurement) and the lowest priority to unobservable inputs (level 3 measurement).
The
Company’s financial instruments consist of cash and cash equivalents, accounts payable and related party loans. The carrying amount
of these financial instruments approximates fair value due either to length of maturity or interest rates that approximate prevailing
market rates unless otherwise disclosed in these financial statements.
Financial
assets and liabilities recorded at fair value in our balance sheet are categorized based upon a fair value hierarchy established
by GAAP, which prioritizes the inputs used to measure fair value into the following levels:
Level
1 — Quoted market prices in active markets for identical assets or liabilities at the measurement date.
Level
2 — Quoted prices for similar assets or liabilities in active markets; quoted prices for identical or similar assets and
liabilities in markets that are not active; or other inputs that are observable and can be corroborated by observable market data.
Level
3 — Inputs reflecting management’s best estimates and assumptions of what market participants would use in pricing assets
or liabilities at the measurement date. The inputs are unobservable in the market and significant to the valuation of the instruments.
A
financial instrument’s categorization within the valuation hierarchy is based upon the lowest level of input that is significant
to the fair value measurement. The Company follows ASC 820’s financial instruments consist of accounts payable and amounts
provided to the Company from related parties. The carrying amount of financial instruments approximates fair value because of
the short-term nature of these items.
Income
taxes
Income
taxes are determined in accordance with the provisions of Financial Accounting Standards Board ASC 740, “Income Taxes”
(“ASC 740”). Under this method, deferred tax assets and liabilities are recognized for the future tax consequences
attributable to differences between the financial statement carrying amounts of existing assets and liabilities and their respective
tax basis. Deferred tax assets and liabilities are measured using enacted income tax rates expected to apply to taxable income
in the years in which those temporary differences are expected to be recovered or settled. Any effect on deferred tax assets and
liabilities of a change in tax rates is recognized in income in the period that includes the enactment date.
ASC
740 prescribes a comprehensive model for how companies should recognize, measure, present, and disclose in their financial statements
uncertain tax positions taken or expected to be taken on a tax return. Under ASC 740, tax positions must initially be recognized
in the financial statements when it is more likely than not the position will be sustained upon examination by the tax authorities.
Such tax positions must initially and subsequently be measured as the largest amount of tax benefit that has a greater than fifty
percent (50%) likelihood of being realized upon ultimate settlement with the tax authority assuming full knowledge of the position
and relevant facts. For the years ended December 31, 2021 and December 31, 2022, the Company did not have any interest and penalties
associated with tax positions. As of December 31, 2022 and December 31, 2021, the Company did not have any significant unrecognized
uncertain tax positions.
Commitments
and Contingencies
The
Company follows ASC 440 and ASC 450, subtopic 450-20 of the FASB Accounting Standards Codification, to report accounting for contingencies
and commitments respectively. Certain conditions may exist as of the date the financial statements are issued, which may result
in a loss to the Company, but which will only be resolved when one or more future events occur or fail to occur. The Company assesses
such contingent liabilities, and such assessment inherently involves an exercise of judgment. In assessing loss contingencies
related to legal proceedings that are pending against the Company or un-asserted claims that may result in such proceedings, the
Company evaluates the perceived merits of any legal proceedings or unasserted claims as well as the perceived merits of the amount
of relief sought or expected to be sought therein.
If
the assessment of a contingency indicates that it is probable that a material loss has been incurred and the amount of the liability
can be estimated, then the estimated liability would be accrued in the Company’s financial statements. If the assessment
indicates that a potentially material loss contingency is not probable but is reasonably possible, or is probable but cannot be
estimated, then the nature of the contingent liability, and an estimate of the range of possible losses, if determinable and material,
would be disclosed.
Share
Capital
Preferred
stock
The
Company is authorized to issue 25,000,000 shares of Preferred Stock, par value $0.001 per share.
Common
stock
The
company is authorized to issue 250,000,000 shares at par value of $0.001 per share.
Recent
Accounting Pronouncements
The
Company reviewed all the recently issued, but not yet effective, accounting pronouncements and we do not believe any of these
pronouncements will have a material impact on the Company.
NOTE
4. GOING CONCERN
The
accompanying audited financial statements have been prepared assuming that the Company will continue as a going concern. The Company
currently has limited liquidity and has not completed its clinical trials of its new products will which are planned to come to
the market. Additionally, the Company has had no assets as of December 31, 2022, and December 31, 2021. The Company had an accumulated
deficit of $5,275,421 and $5,131,708 as of December 31, 2022, and December 31, 2021 respectively. And the Company had a working
capital deficit of $143,713 as of December 31, 2022, and working capital of $0 as of December 31, 2021. These factors, raises
doubt about its ability to continue as a going concern. The financial statements do not include any adjustments that may result
from the outcome of these uncertainties. The Company will require additional financing moving forward and is pursuing various
strategies to accomplish this, including seeking equity funding and/or debt funding from private placement sources. Although management
believes that it will be able to obtain the necessary funding to allow the Company to remain a going concern through the methods
discussed above, there can be no assurances that such methods will prove successful. Management anticipates that the Company will
be dependent, for the near future, on additional investment capital to fund operating expenses. There are no assurances that the
Company will be successful in this or any of its endeavors or become financially viable and continue as a going concern.
NOTE
5. INCOME TAXES
The
Company records its federal and state income tax liability as it is incurred. The Company had no income tax expense for the years
ended December 31, 2021 and 2022 and does not have any outstanding income tax liabilities, deferred tax assets, or liabilities
for the years then ended.
NOTE
6. RELATED PARTY TRANSACTION
In support of the Company’s efforts
and cash requirements, it may rely on advances from related parties until such time that the Company can support its operations
or attains adequate financing through sales of its equity or traditional debt financing. There is no formal written commitment
for continued support by officers, directors, or shareholders. Amounts represent advances or amounts paid in satisfaction of liabilities
and related parties consist of officers, shareholders, and associated entities. The Company currently has no related party loans.
NOTE
7. SUBSEQUENT EVENTS
The
Company evaluated all other events or transactions that occurred after December 31, 2022, through July 11, 2023. The Company determined
that it had the following Subsequent Events:
Stockholders’
Equity
On April 25, 2023, the Company filed
a Certificate of Correction to the articles of incorporation with the State of Delaware that increased the total authorized shares
to 500,000,000 at par value of $0.001 per share with common shares numbering 495,000,000 and Series A Super Voting Preferred shares
numbering 5,000,000. On December 20, 2018, the Company issued 2,500,000 shares of Series A Super Voting Preferred stock.
A. Series
A Super Voting Preferred Shares.
1. Voting.
Holders of the Series A Super Voting Preferred Shares shall have five hundred (500) times that number of votes on all matters
submitted to the shareholders that each shareholder of the Company’s Common Stock (rounded to the nearest whole number)
is entitled to vote at each meeting of shareholders of the Company (and written actions of shareholders in lieu of meetings) with
respect to any and all matters presented to the shareholders of the Company for their action or consideration. Holders of the
Series A Super Voting Preferred Shares shall vote together with the holders of Common Stock as a single class.
2. Dividends.
Holders of Series A Super Voting Preferred Shares shall not be entitled to receive dividends paid on the Company’s Common
Stock. Dividends paid to holders of the Series A Super Voting Preferred Shares, if any, shall be at the discretion of the board
of directors (the “Board”).
3. Liquidation
Preference. Upon the liquidation, dissolution and winding up of the Company, whether voluntary or involuntary, holders of the
Series A Super Voting Preferred Shares shall not be entitled to receive any of the assets of the Company.
4. No
Conversion. The shares of Series A Super Voting Preferred Shares shall not be convertible into shares of the Company’s Common
Stock.
5. Vote
to Change the Terms of, or to Issue, Series A Super Voting Preferred Shares. The affirmative vote at a meeting duly called for
such purpose, or the written consent without a meeting, of the holders of not less than fifty-one percent (51%) of the then-outstanding
shares of Series A Super Voting Preferred Shares shall be required for (a) any change to the Company’s Articles of Incorporation
that would amend, alter, change or repeal any of the preferences, limitations or relative rights of the Series A Super Voting
Preferred Shares or (b) any issuance of additional shares of Series A Super Voting Preferred Shares.
6. Record
Owner. The Company may deem the person in whose name Series A Super Voting Preferred Shares shall be registered upon the registry
books of the Company to be, and may treat him as, the absolute owner of the Series A Super Voting Preferred Shares for all purposes,
and the Company shall not be affected by any notice to the contrary.
7. Register.
The Company shall maintain a register for the registration of the Series A Super Voting Preferred Shares. Upon the transfer of
shares of Series A Super Voting Preferred Shares in accordance with the provisions hereof, the Company shall register such transfer
on the register of the Series A Super Voting Preferred Shares.
B. Common
Stock.
1. The
rights of holders of Common Stock to receive dividends or share in the distribution of assets in the event of liquidation, dissolution
or winding up of the affairs of the Company shall be subject to the preferences, limitations and relative rights of the Series
A Super Voting Preferred Shares fixed in the resolution or resolutions which may be adopted from time to time by the Board or
the Company providing for the issuance of one or more series of the Series A Super Voting Preferred Shares.
2. The
holders of the Common Stock shall be entitled to one vote for each share of Common Stock held by them of record at the time for
determining the holders thereof entitled to vote.
No
holder of shares of the Company of any class shall have any preemptive or preferential right in or preemptive or preferential
right to subscribe to or for or acquire any new or additional shares, or any subsequent issue of shares, or any unissued or treasury
shares of the Company, whether now or hereafter authorized, or any securities convertible into or carrying a right to subscribe
to or for or acquire any such shares, whether nor or hereafter authorized. All shares are to be non-assessable.
New
Stock Issuances
Stock
issuances with services provided and cash receipts rendered after December 31, 2022, and issued May 4, 2023.
Shareholders | Number of Shares |
Consideration | Type |
CONSULTANT | 1,500,000 | $1,500 | Services rendered. |
CONSULTANT | 2,500,000 | $2,500 |
Services rendered. |
CONSULTANT | 150,000 | $150 | Services rendered. |
CONSULTANT | 7,500,000 | $7,500 | Services rendered. |
UNRELATED PARTY/SHAREHOLDER |
100,000 | $10,000 | Cash received. |
UNRELATED PARTY/SHAREHOLDER |
2,000,000 | $200,000 | Cash received. |
UNRELATED PARTY/SHAREHOLDER |
1,000,000 | $100,000 | Cash received. |
UNRELATED PARTY/SHAREHOLDER |
500,000 | $50,000 | Cash received. |
UNRELATED PARTY/SHAREHOLDER |
250,000 | $25,000 | Cash received. |
UNRELATED PARTY/SHAREHOLDER |
1,000,000 | $100,000 | Cash received. |
UNRELATED PARTY/SHAREHOLDER |
1,000,000 | $100,000 | Cash received. |
The
issuances for each “UNRELATED PARTY/SHAREHOLDER” were part of a funding round in which each investor purchased shares
at the purchase price of $0.10 per a share of Common Stock and Warrant, with Warrants convertible at an exercise price equal to
$0.15 per Warrant.
The issuances for each “CONSULTANT”
were for work performed on behalf of Redwood Scientific Technologies, Inc. Of these issuances, 4,000,000 shares were for legal
services, 150,000 shares were for accounting services, and 7,500,000 shares were for consulting services.
Stock
issuances with services provided and cash receipts rendered after December 31, 2022, and issued June 30, 2023.
Shareholders | Number of Shares |
Consideration | Type |
CONSULTANT | 550,000 | $550 | Services rendered. |
CONSULTANT | 250,000 | $250 | Services rendered. |
CONSULTANT | 300,000 | $300 | Services rendered. |
CONSULTANT | 200,000 | $200 | Services rendered. |
CONSULTANT | 100,000 | $100 | Services rendered. |
CONSULTANT | 150,000 | $150 | Services rendered. |
CONSULTANT | 100,000 | $100 | Services rendered. |
CONSULTANT | 1,500,000 | $1,500 | Services rendered. |
UNRELATED PARTY/SHAREHOLDER |
50,000 | $5,000 | Cash received. |
UNRELATED PARTY/SHAREHOLDER |
1,000,000 | $100,000 | Cash received. |
UNRELATED PARTY/SHAREHOLDER |
1,250,000 | $125,000 | Cash received. |
UNRELATED PARTY/SHAREHOLDER |
1,000,000 | $100,000 | Cash received. |
The
issuances for each “UNRELATED PARTY/SHAREHOLDER” were part of a funding round in which each investor purchased shares
at the purchase price of $0.10 per a share of Common Stock and Warrant, with Warrants convertible at an exercise price equal to
$0.15 per Warrant.
The issuances for each “CONSULTANT”
were for work performed on behalf of Redwood Scientific Technologies, Inc. Of these issuances, 550,000 shares were for legal services,
700,000 shares were for managerial services, 200,000 shares were for accounting services, 100,000 shares were for director services,
and 1,600,000 shares were for consulting services.
Stock
issuances with services provided and cash receipts rendered after December 31, 2022, and yet to be issued.
Shareholders | Number of Shares |
Consideration | Type |
CONSULTANT | 100,000 | $100 | Services rendered. |
UNRELATED PARTY/SHAREHOLDER |
2,00,000 | $200,000 | Cash received. |
UNRELATED PARTY/SHAREHOLDER |
250,000 | $25,000 | Cash received. |
The
issuances for each “UNRELATED PARTY/SHAREHOLDER” is part of a funding round in which each investor purchased shares
at the purchase price of $0.10 per a share of Common Stock and Warrant, with Warrants convertible at an exercise price equal to
$0.15 per Warrant.
The
issuance for the “CONSULTANT” is for work performed on behalf of Redwood Scientific Technologies, Inc.
REDWOOD
SCIENTIFIC TECHNOLOGIES, INC.
Unaudited June 30, 2023 |
Audited Dec 31, 2022 |
|||||||
Assets: | ||||||||
Cash | $ | 646,826 | 0 | |||||
Total current assets | $ | 646,826 | $ | 0 | ||||
TOTAL ASSETS | $ | 646,826 | $ | 0 | ||||
Liabilities and Stockholder’s Deficit: | ||||||||
Current Liabilities: | ||||||||
Accounts payable & accruals | $ | 163,322 | $ | 143,713 | ||||
Tol Current liabilities | $ | 163,322 | $ | 143,713 | ||||
TOTAL LIABILITIES | $ | 163,322 | $ | 143,713 | ||||
Stockholders’ Equity: | ||||||||
Common Stock | $ | 204,227 | $ | 177,927 | ||||
Preferred Stock | ||||||||
Additional Paid-in-capital | $ | 6,082,381 | $ | 4,953,781 | ||||
Accumulated Deficit | $ | (5,803,104 | ) | $ | (5,275,421 | ) | ||
TOTAL STOCKHOLDERS’ EQUITY/(DEFICIT) | $ | 483,504 | $ | (143,713 | ) | |||
TOTAL LIABILITIES AND STOCKHOLDERS’ EQUITY | $ | 646,826 | $ | 0 |
REDWOOD
SCIENTIFIC TECHNOLOGIES, INC.
(Unaudited)
Three Months Ended June 30,2023 |
June 30,2022 | Six Months Ended June 30, 2023 |
June 30, 2022 | |||||||||||||
INCOME | ||||||||||||||||
Income | $ | 0 | $ | 0 | $ | 0 | $ | 0 | ||||||||
Total ordinary income/expense | $ | 0 | $ | 0 | $ | 0 | $ | 0 | ||||||||
EXPENSES: | ||||||||||||||||
Operating Expenses: | ||||||||||||||||
General & Administrative | $ | 315,998 | $ | 0 | $ | 527,683 | $ | 0 | ||||||||
Total Operating Expenses | $ | 315,998 | $ | 0 | $ | 5276383 | $ | 0 | ||||||||
Loss from operations | $ | (315,998 | ) | $ | 0 | $ | (527,683 | ) | $ | 0 | ||||||
Other income (expenses): | ||||||||||||||||
Income taxes | ||||||||||||||||
Penalties | ||||||||||||||||
State Tax | $ | 0 | ||||||||||||||
Total other income (expenses) | $ | 0 | $ | 0 | $ | 0 | $ | 0 | ||||||||
Net Loss | $ | (315,998 | ) | $ | 0 | $ | (527,683 | ) | $ | 0 | ||||||
Net Loss per share | $ | (0.00 | ) | $ | 0.00 | $ | (0.00 | ) | $ | 0.00 | ||||||
Weighted average shares outstanding | 188,959,552 | 177,927,134 | 183,473,819 | 177,927,134 |
REDWOOD
SCIENTIFIC TECHNOLOGIES, INC.
Statements
Of Changes In Stockholders’ Equity (Deficit)
(Unaudited)
For
the period ended June 30, 2023 and 2022
Shares | Common Stock Shares to be issued |
Par Value | Additional Paid-In Capital | Accumulated Deficit | Stockholders’ Equity/ (Deficiency) | |||||||||||||||||||
Balance as of December 31, 2022 | 177,927,134 | $ | 177,927 | $ | 4,953,781 | $ | (5,275,421 | ) | $ | (143,713 | ) | |||||||||||||
Shares Issued | 23,950,000 | $ | 23,950 | $ | 905,850 | $ | 929,800 | |||||||||||||||||
Shares to be Issued | 2,350,000 | $ | 2,350 | 222,750 | $ | 225,100 | ||||||||||||||||||
Net Loss | $ | (527,683 | ) | $ | (527,683 | ) | ||||||||||||||||||
Balance as of June 30, 2023 |
201,877,134 | 2,350,000 | $204,227 | $6,082,381 | $ | (5,803,104 | ) | $ | 483,504 | |||||||||||||||
Balance as of December 31, 2021 | 177,927,134 | 0 | $ | 177,927 | $ | 4,953,781 | $ | (5,131,708 | ) | $0 | ||||||||||||||
Additions in the Year | 0 | 0 | 0 | 0 | 0 | 0 | ||||||||||||||||||
Adjustment of year | 0 | 0 | 0 | 0 | 0 | 0 | ||||||||||||||||||
Net Loss/Surplus | 0 | 0 | 0 | 0 | 0 | 0 | ||||||||||||||||||
Balance as of June 30, 2022 |
177,927,134 | 0 | $ | 177,927 | $ | 4,953,781 | $ | (5,131,708 | ) | $ | 0 |
REDWOOD
SCIENTIFIC TECHNOLOGIES, INC.
(Unaudited)
June 30, 2023 | June 30, 2022 | |||||||
Cash flows from operating activities: |
||||||||
Net loss | $ | (527,683 | ) | — | ||||
Adjustments to reconcile net loss to net cash used in operating activities: |
||||||||
Accounts payable and accrued expenses |
$ | 19,610 | — | |||||
Net cash used in operating activities | $ | (508,073 | ) | — | ||||
Cash flows from financing activities: |
||||||||
Additions of Common Stock | $ | 1,154,900 | — | |||||
Net cash provided by financing activities | $ | 1,154,900 | — | |||||
Net (decrease) increase in cash | $ | 646,826 | — | |||||
Cash at beginning of period | $ | 0 | ||||||
Cash at end of period | $ | 646,826 | — |
Redwood
Scientific Technologies, Inc.
For
the quarter ended June 30, 2023
NOTE 1. FORMATION AND BUSINESS OF THE COMPANY
Business description
Redwood Scientific Technologies, Inc.
(“Redwood”, “RSCI”, or the “Company”) is a pharmaceutical company that develops, operates,
and markets innovative over-the-counter United States Food and Drug Administration (“FDA”) registered drugs in a sublingual
oral thin film strip. The Company has announced that it is starting the beginning phases of research for clinical trials on two
new products that will be marketed to help stop the addiction to nicotine.
NOTE 2. EFFECT OF RECEIVERSHIP
The Company emerged from receivership
in March of 2022. All assets and liabilities prior to emergence had been liquidated. As such the company started with a blank
set of financials.
The Company was in a court ordered
Receivership during “FTC v. Redwood Scientific Technologies, Inc., Case. No. 5:18-02104 (C.D. Cal.)”, filed on October
3, 2018. The case was decided and the Company was released from the Receivership in March of 2022. Under the Court’s practice,
a Receivership is, for all intents treated as a bankruptcy for the purpose of debts and liabilities.
The Receiver did not report any liabilities
on Redwood’s books and records. It should be noted that the Court authorized the destruction of Redwood’s books and
records in its Order Approving the Receiver’s Final Report and Accounting, and the Receiver’s Final Fee Application.
All debts and liabilities due from
and owed by Redwood Scientific Technologies, Inc. were released as of the termination of the Receivership and did not survive
the receivership. Accordingly, the debts and liabilities have been extinguished as of the year ended December 31, 2022 and December
31, 2021. In addition, the trial court held that no monetary remedies would be allowed against Redwood and other defendants. Moreover,
any claim that might have been made by the FTC is barred by the three-year statute of limitations applicable to this case effective
October 3, 2022.
NOTE 3. SIGNIFICANT ACCOUNTING POLICIES
Uses of estimates
The preparation of financial statements
in conformity with generally accepted accounting principles accepted in the United States of America (“GAAP”) requires
management to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent
assets and liabilities at the date of the financial statements and the reported amounts of net revenue and expenses during each
reporting period. Actual results could differ from those estimates.
Cash
The Company considers all short-term
highly liquid investments with an original maturity date of purchase of three months or less to be cash equivalents.
Revenue Recognition
The Company did not have any revenues
from continuing operations for the periods presented. The Company recognizes revenue based on Accounting Standards Codification
(“ASC”) 606, Revenue from Contracts with Customers and all of the related amendments, and the Company’s policy
is revenues will be recognized when control of the products are transferred to the Company’s distributors.
Financial Instruments
As defined in Financial Accounting
Standards Board ASC 820 (“FASB ASC 820”), fair value is the price that would be received to sell an asset or paid
to transfer a liability in an orderly transaction between market participants at the measurement date (exit price). The Company
will utilize the market data of similar entities in its industry or assumptions that market participants would use in pricing
the asset or liability, including assumptions about risk and the risks inherent in the inputs to the valuation technique. These
inputs can be readily observable, market corroborated, or generally unobservable. The Company classifies fair value balances based
on the observability of those inputs. FASB ASC 820 establishes a fair value hierarchy that prioritizes the inputs used to measure
fair value. The hierarchy gives the highest priority to unadjusted quoted prices in active markets for identical assets or liabilities
(level 1 measurement) and the lowest priority to unobservable inputs (level 3 measurement).
The Company’s financial instruments
consist of cash and cash equivalents, and accounts payable. The carrying amount of these financial instruments approximates fair
value due either to length of maturity or interest rates that approximate prevailing market rates unless otherwise disclosed in
these financial statements.
Financial assets and liabilities recorded
at fair value in the Company’s balance sheet are categorized based upon a fair value hierarchy established by GAAP, which
prioritizes the inputs used to measure fair value into the following levels:
Level 1 — Quoted market prices
in active markets for identical assets or liabilities at the measurement date.
Level 2 — Quoted prices for similar
assets or liabilities in active markets; quoted prices for identical or similar assets and liabilities in markets that are not
active; or other inputs that are observable and can be corroborated by observable market data.
Level 3 — Inputs reflecting management’s
best estimates and assumptions of what market participants would use in pricing assets or liabilities at the measurement date.
The inputs are unobservable in the market and significant to the valuation of the instruments.
A financial instrument’s categorization
within the valuation hierarchy is based upon the lowest level of input that is significant to the fair value measurement. The
Company follows ASC 820’s financial instruments consist of accounts payable and amounts provided to the Company from related
parties. The carrying amount of financial instruments approximates fair value because of the short-term nature of these items.
Income taxes
Income taxes are determined in accordance
with the provisions of Financial Accounting Standards Board ASC 740, “Income Taxes” (“ASC 740”). Under
this method, deferred tax assets and liabilities are recognized for the future tax consequences attributable to differences between
the financial statement carrying amounts of existing assets and liabilities and their respective tax basis. Deferred tax assets
and liabilities are measured using enacted income tax rates expected to apply to taxable income in the years in which those temporary
differences are expected to be recovered or settled. Any effect on deferred tax assets and liabilities of a change in tax rates
is recognized in income in the period that includes the enactment date.
ASC 740 prescribes a comprehensive
model for how companies should recognize, measure, present, and disclose in their financial statements uncertain tax positions
taken or expected to be taken on a tax return. Under ASC 740, tax positions must initially be recognized in the financial statements
when it is more likely than not the position will be sustained upon examination by the tax authorities. Such tax positions must
initially and subsequently be measured as the largest amount of tax benefit that has a greater than fifty percent (50%) likelihood
of being realized upon ultimate settlement with the tax authority assuming full knowledge of the position and relevant facts.
For the quarter ended June 30, 2023, the Company did not have any interest and penalties associated with tax positions. As of
June 30, 2023, the Company did not have any significant unrecognized uncertain tax positions.
Commitments and Contingencies
The Company follows ASC 440 and ASC
450, subtopic 450-20 of the FASB Accounting Standards Codification, to report accounting for contingencies and commitments respectively.
Certain conditions may exist as of the date the financial statements are issued, which may result in a loss to the Company, but
which will only be resolved when one or more future events occur or fail to occur. The Company assesses such contingent liabilities,
and such assessment inherently involves an exercise of judgment. In assessing loss contingencies related to legal proceedings
that are pending against the Company or un-asserted claims that may result in such proceedings, the Company evaluates the perceived
merits of any legal proceedings or unasserted claims as well as the perceived merits of the amount of relief sought or expected
to be sought therein.
If the assessment of a contingency
indicates that it is probable that a material loss has been incurred and the amount of the liability can be estimated, then the
estimated liability would be accrued in the Company’s financial statements. If the assessment indicates that a potentially
material loss contingency is not probable but is reasonably possible, or is probable but cannot be estimated, then the nature
of the contingent liability, and an estimate of the range of possible losses, if determinable and material, would be disclosed.
Share Capital
Preferred stock
The Company is authorized to issue
5,000,000 shares of Preferred Stock, par value $0.001 per share.
Common stock
The Company is authorized to issue
495,000,000 shares at par value of $0.001 per share.
Recent Accounting Pronouncements
The Company reviewed all the recently
issued, but not yet effective, accounting pronouncements and the Company does not believe any of these pronouncements will have
a material impact on the Company.
NOTE 4. GOING CONCERN
The accompanying financial statements
have been prepared assuming that the Company will continue as a going concern. The Company currently has limited liquidity and
has not completed its clinical trials of its new products which are planned to come to the market. The Company had an accumulated
deficit of $5,803,104 as of June 30, 2023. Revenue has not been generated as of June 30, 2023. These factors raise doubt about
its ability to continue as a going concern. The financial statements do not include any adjustments that may result from the outcome
of these uncertainties. The Company will require additional financing moving forward and is pursuing various strategies to accomplish
this, including seeking equity funding and/or debt funding from private placement sources. Although management believes that it
will be able to obtain the necessary funding to allow the Company to remain a going concern through the methods discussed above,
there can be no assurances that such methods will prove successful. Management anticipates that the Company will be dependent,
for the near future, on additional investment capital to fund operating expenses. There are no assurances that the Company will
be successful in this or any of its endeavors or become financially viable and continue as a going concern.
NOTE 5. INCOME TAXES
The Company records its federal and
state income tax liability as it is incurred. The Company had no income tax expense for the quarter ending June 30, 2023, and
does not have any outstanding income tax liabilities, deferred tax assets, or liabilities for the quarter then ended.
NOTE 6. RELATED PARTY TRANSACTION
In support of the Company’s efforts
and cash requirements, it may rely on advances from related parties until such time that the Company can support its operations
or attains adequate financing through sales of its equity or traditional debt financing. There is no formal written commitment
for continued support by officers, directors, or shareholders. Amounts represent advances or amounts paid in satisfaction of liabilities
and related parties consist of officers, shareholders, and associated entities. There are no advances from related parties currently
outstanding.
NOTE 7. CHANGE IN CONTROL
The Company recently experienced a
change in control as the Board and Officers of the Company has changed in March 2023. On March 23, 2023, the Board resolved to
appoint the following members of the Board: (i) Jason Cardiff, (ii) Christine Hayes, and (iii) Brian Kennedy. Also on March 23,
2023, the Board resolved to name to following Officers of the Company: Jason Cardiff as Chief Executive Officer, David Duncan
as Chief Financial Officer, and Bobby Bedi as Chief Operating Officer.
On March 24, 2023, the Chief Operating
Officer (“COO”) of the Company, Bobby Bedi, departed this life. On March 25, 2023, previous Chief Financial Officer
(“CFO”), David Duncan, was named the interim COO of the Company, and John Harrington was named the interim CFO of
the Company. Then, on May 8, 2023, the Board officially appointed David Duncan the COO of the Company, and officially appointed
John Harrington the CFO of the Company.
NOTE 8. SUBSEQUENT EVENTS
The Company evaluated all other events
or transactions that occurred after June 30, 2023, through August 21, 2023, and the Company determined that it had the following
Subsequent Event:
The following stock issuance has $25,000
worth of cash receipts prior to June 30, 2023, and $50,000 worth of cash receipts after June 30, 2023, and this issuance is yet
to be issued.
Shareholders | Number of Shares |
Consideration | Type |
UNRELATED PARTY/SHAREHOLDER |
750,000 | $75,000 | Cash received. |
The issuance for the “UNRELATED
PARTY/SHAREHOLDER” was part of a funding round in which the investor purchased shares at the purchase price of $0.10 per
a share of Common Stock and Warrant, with Warrants convertible at an exercise price equal to $0.15 per Warrant.
ATTACHMENTS / EXHIBITS
Source: https://www.streetinsider.com/SEC+Filings/Form+10-12GA+Redwood+Scientific+Techn/22081443.html