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PART
I
Item
1. Business
Background
Business
Overview
Sigyn
Therapeutics, Inc. (“Sigyn”, the “Company”, “we,” “us,” or “our”) is a development-stage
company focused on creating therapeutic solutions that address unmet needs in global health. Our corporate address is 2468 Historic Decatur
Road, Suite 140, San Diego, California, 92106.
Sigyn
Therapy™, our lead product candidate, is a broad-spectrum blood purification technology designed to treat pathogen-associated inflammatory
disorders that are not addressed with approved drug therapies. Candidate treatment indications include endotoxemia and inflammation in
end-stage renal disease (dialysis) patients, sepsis (a leading cause of hospital deaths), community acquired pneumonia (a leading cause
of death among infectious diseases), and emerging pandemic threats.
Our
development pipeline includes a cancer treatment system comprised of ChemoPrep™ to enhance the tumor site delivery of chemotherapy,
and ChemoPure™ to reduce treatment toxicity and inhibit the spread of cancer metastasis.
Merger
Transaction
On
October 19, 2020, Sigyn Therapeutics, Inc, a Delaware corporation (the “Registrant”) formerly known as Reign Resources Corporation,
completed a Share Exchange Agreement (the “Agreement”) with Sigyn Therapeutics, Inc., a private entity incorporated in the
State of Delaware on October 19, 2019.
In
the Share Exchange Agreement, we acquired 100% of the issued and outstanding shares of privately held Sigyn Therapeutics common stock
in exchange for 75% of the fully paid and nonassessable shares of our common stock outstanding (the “Acquisition”). In conjunction
with the transaction, we changed our name from Reign Resources Corporation to Sigyn Therapeutics, Inc. pursuant to an amendment to our
articles of incorporation that was filed with the State of Delaware. Subsequently, our trading symbol was changed to SIGY. The Acquisition
was treated by the Company as a reverse merger in accordance with accounting principles generally accepted in the United States of America
(“GAAP”). For accounting purposes, Sigyn is considered to have acquired Reign Resources Corporation as the accounting acquirer
because: (i) Sigyn stockholders own 75% of the combined company, on an as-converted basis, immediately following the Closing Date, (ii)
Sigyn directors hold a majority of board seats in the combined company and (iii) Sigyn management held all key positions in the management
of the combined company. Accordingly, Sigyn’s historical results of operations will replace Reign Resources Corporation’s
historical results of operations for all periods prior to the Acquisition and, for all periods following the Acquisition, the results
of operations of the combined company will be included in the Company’s financial statements. The
Acquisition was treated as a “tax-free exchange” under Section 368 of the Internal Revenue Code of 1986 and resulted in the
private Sigyn Therapeutics corporate entity (established on October 29, 2019) to become a wholly owned subsidiary of Reign Resources
Corporation. Among the conditions for closing the acquisition, the Reign Resources Corporation extinguished all previously reported liabilities,
its preferred class of shares, and all stock purchase options. As a result, the reported liabilities totalling $3,429,516 were converted
into a total of 7,907,351 common shares. Additionally, assets held on the books of Reign Resources
Corporation, such as Gem inventory, was kept in the Company and therefore recorded as assets on the Share Exchange date. Upon
the closing of the Acquisition, we appointed James A. Joyce and Craig P. Roberts to serve as members of our Board of Directors.
As
of March 31, 2023, we had a total 42,713,325 shares issued and outstanding, of which 17,073,325 shares are held by non-affiliate shareholders.
Post-Merger
Developments
Since
the consummation of the Acquisition on October 19, 2020, we have advanced Sigyn Therapy from conceptual design through completion of
in vitro studies that have quantified the reduction of relevant therapeutic targets from human blood plasma with small-scale versions
of Sigyn Therapy. These include endotoxin (gram-negative bacterial toxin); peptidoglycan and lipoteichoic acid (gram-positive bacterial
toxins); viral pathogens (including SARS-CoV-2); hepatic toxins (ammonia, bile acid, and bilirubin); and tumour necrosis factor alpha
(TNF alpha), interleukin-1 beta (IL-1b), and interleukin 6 (IL-6), which are pro-inflammatory cytokines whose dysregulated production
(the cytokine storm) precipitate sepsis and play a prominent role in each of our therapeutic opportunities.
Subsequent
to these studies, we disclosed the completion of in vivo animal studies. In these studies, Sigyn Therapy was administered via
standard dialysis machines utilizing conventional blood-tubing sets, for periods of up to six hours in eight (8) porcine (pig) subjects,
each weighing approximately 40-45 kilograms. The studies were comprised of a pilot phase (two subjects), which evaluated the feasibility
of the study protocol in the first-in-mammal use of Sigyn Therapy; and an expansion phase (six subjects) to further assess treatment
feasibility and refine pre-treatment set-up and operating procedures. There were no serious adverse events reported in any of the treated
animal subjects. Of the eight treatments, seven were administered for the entire six-hour treatment period. One treatment was halted
early due to the observation of a clot in the device, which was believed to be the result of a procedural deviation in the pre-treatment
set-up. Important criteria for treatment feasibility – including hemodynamic parameters, serum chemistries and hematologic measurements
– were stable across all subjects.
The
studies were conducted by a clinical team at Innovative BioTherapies, Inc. (“IBT”), under a contract with the University
of Michigan to utilize animal care, associated institutional review oversight, as well as surgical suite facilities located within the
North Campus Research Complex. The treatment protocol of the study was reviewed and approved by the University of Michigan Institutional
Animal Care and Use Committee (IACUC).
The
animal studies were conducted to correspond with FDA’s best practice guidance. The number of animals enrolled in our study and
the amount of data collected was based on the ethical and least burdensome principles that underly the FDA goal of using the minimum
number of animals necessary to generate valid scientific data to demonstrate reasonable feasibility and performance of a medical device
prior to human study consideration. A porcine animal model is a generally accepted model for the study of extracorporeal blood purification
devices intended to treat infectious disease and inflammatory disorders. Regardless of these factors, FDA may require that we conduct
additional animal studies.
The
data resulting from our in vivo and in vitro studies is being incorporated into an Investigational Device Exemption (IDE) that
we are drafting for submission to the U.S. Food and Drug Administration (“FDA”) to support the potential initiation of a
human feasibility study in End-Stage Renal Disease (ESRD) patients with endotoxemia and elevated inflammatory cytokine production. As
per the study protocol, Sigyn Therapy is to be administered in combination with the regularly scheduled dialysis treatments of enrolled
subjects. The primary study objective will be to evaluate the safety of Sigyn Therapy in health compromised ESRD patients. A secondary
objective will be to quantify changes in circulating levels of endotoxin, tumour necrosis factor-αlpha (TNF-α), interleukin-1β
(IL-1β), and interleukin-6 (IL-6) before and after each Sigyn Therapy administration. Endotoxin and excess TNF-α, IL-1β,
and IL-6 production are commonly associated with each of our candidate treatment indications, including sepsis and community-acquired
pneumonia.
Based
on our previous experience in developing extracorporeal blood purification therapies, we believe that we have collected sufficient data
to support first-in-human studies of Sigyn Therapy. In this regard, we plan to submit an IDE application to FDA related to the potential
initiation of a human feasibility study during the 2023 calendar year. However, there is no assurance that FDA will approve the initiation
of our feasibility study. Additionally, while we believe the data from our in vivo and in vitro studies provides support for our
IDE submission, FDA may request that we conduct additional animal or pre-clinical studies prior to approving our IDE. Among our previous
experiences in developing extracorporeal blood purification therapies, our CEO oversaw the development of the Aethlon Hemopurifier, a
first-in-industry device that received an FDA “Breakthrough Device” designation for the treatment of life-threatening viruses
and was awarded a second FDA “Breakthrough Device” designation related to the treatment of cancer.
Sigyn
Therapy Mechanism of Action
We
designed Sigyn Therapy to be a candidate to treat pathogen-associated inflammatory conditions that are life-threatening. To date, pre-clinical
in vitro studies have quantified the reduction of viral pathogens, bacterial toxins, and inflammatory mediators from human blood
plasma with small-scale versions of Sigyn Therapy. Such capabilities establish Sigyn Therapy as a candidate to treat pathogen-associated
conditions that precipitate Sepsis, Community Acquired Pneumonia, Emerging Bioterror and Pandemic threats, and End-Stage Renal Disease
patients with endotoxemia and elevated inflammatory cytokine production.
To
support widespread implementation, Sigyn Therapy is a single-use disposable device that is deployable on the global infrastructure of
hemodialysis and continuous renal replacement therapy (CRRT) machines already located in hospitals and clinics. To reduce the risk of
blood clotting and hemolysis, the anticoagulant heparin is administered, which is the standard-of-care drug administered in dialysis
and CRRT therapies. During animal studies conducted at the University of Michigan, Sigyn Therapy was deployed for use on a hemodialysis
machine manufactured by Fresenius Medical Care, the global leader in the dialysis industry.
Incorporated
within Sigyn Therapy is a “cocktail” of adsorbent components formulated to optimize the broad-spectrum reduction of therapeutic
targets from the bloodstream. In the medical field, the term “cocktail” is a reference to the simultaneous administration
of multiple drugs (a drug cocktail) with differing mechanisms of actions. While drug cocktails are emerging as potential mechanisms to
treat cancer, they are life-saving countermeasures to treat HIV and Hepatitis-C viral infections. However, dosing of multi-drug agent
cocktails is limited by toxicity and adverse events that can result from deleterious drug interactions.
Sigyn
Therapy is not constrained by such limitations as active adsorbent components are maintained within Sigyn Therapy and not introduced
into the body. As a result, we are able to incorporate a substantial quantity of adsorbent components to capture therapeutic targets
outside of the body as they circulate through Sigyn Therapy. Each adsorbent component has differing capture characteristics that contribute
to optimizing the potential of Sigyn Therapy to reduce the presence of pathogenic and inflammatory targets that precipitate the cytokine
storm that underlies sepsis and other life-threatening inflammatory disorders.
The
adsorbent components incorporated within Sigyn Therapy provide more than 200,000 square meters (~50 acres) of surface area on which to
adsorb and remove circulating viruses, bacterial toxins, and inflammatory mediators. Beyond a potential capacity to reduce therapeutic
targets from human blood plasma, we believe that Sigyn Therapy offers an efficient treatment methodology. Based on targeted blood flow
rates of 350ml/min, a patient’s entire bloodstream can pass through Sigyn Therapy more than fifteen times during a single four-hour
treatment period.
From
a technical perspective, Sigyn Therapy is a 325mm long polycarbonate column that internally contains polyethersulphone hollow fibers
that have porous walls with a median pore size of ~200 nanometers (nm). As blood flows into Sigyn Therapy, plasma and therapeutic targets
below 200nm travel through the porous walls as a result of blood-side pressure. As the hollow fiber bundle within Sigyn Therapy creates
a resistance to the flow of blood, a pressure drop is created along the length of the device such that the blood-side pressure is higher
at the blood inlet and lower at the blood outlet. This allows for plasma and therapeutic targets to flow away from the blood and into
the extra-lumen space (inside the polycarbonate shell, yet outside the hollow-fiber bundle) to interact with Sigyn Therapy’s adsorbent
components in a low shear force environment. In the distal third of the fiber bundle, the pressure gradient is reversed, which allows
for plasma to flow back through the fiber walls to be reconvened into the bloodstream without the presence of therapeutic targets that
were captured or bound by adsorbent components housed in the extra-lumen space of Sigyn Therapy.
Overview
of Candidate Treatment Indications
Based
on data resulting from in vitro blood purification studies, our candidate treatment indications include, but are not limited
to; pathogen-associated inflammatory conditions that precipitate Sepsis (leading cause of hospital deaths worldwide), Community
Acquired Pneumonia (a leading cause of death among infectious diseases), Emerging Bioterror and Pandemic threats, and endotoxemia
and inflammation in End-Stage Renal Disease (ESRD) patients. However,
there is no assurance that human feasibility and pivotal studies will demonstrate Sigyn Therapy to be a safe and efficacious
treatment for any treatment indications.
End-Stage
Renal Disease, Endotoxemia and Inflammation
According
to the United States Renal Data System (USRDS), more than 550,000 individuals suffer from end-stage renal disease (ESRD), which results
in approximately 85 million kidney dialysis treatments being administered in the United States each year. Persistent inflammation is
a hallmark feature of ESRD as reflected by the excess production of inflammatory cytokines, including tumour necrosis factor-α
(TNF-α), interleukin-1β (IL-1β) and interleukin-6 (IL-6), which contribute to increased all-cause mortality. ESRD inflammation
also induces intestinal permeability, which allows endotoxin (gram-negative bacterial toxin) to translocate from the gut and into the
bloodstream. Beyond fuelling further inflammation, endotoxin is potent activator of sepsis, which can lead to multiple organ failure
and ultimately death.
Sigyn
Therapy establishes a candidate strategy to improve the health and quality-of-life of ESRD patients. Beyond its potential to reduce endotoxin,
TNF-α, IL-1β, and IL-6 from human blood plasma, Sigyn Therapy can be administered in series with regularly scheduled dialysis
therapy.
We
are currently preparing an Investigational Device Exemption (IDE) for submission to the U.S. Food and Drug Administration (“FDA”)
related to a human feasibility study of Sigyn Therapy in ESRD patients with endotoxemia and elevated inflammatory cytokine production.
As per the study protocol, Sigyn Therapy will be administered in combination with the regularly scheduled dialysis treatments of enrolled
subjects. The primary study objective will be to evaluate the safety of Sigyn Therapy in health compromised ESRD patients. A secondary
objective is to quantify changes in circulating levels of endotoxin, tumour necrosis factor-α (TNF-α), interleukin-1β
(IL-1β), and interleukin-6 (IL-6) before and after each Sigyn Therapy administration. Endotoxin and excess TNF-α, IL-1β,
and IL-6 production are commonly associated with each of our candidate treatment indications, including sepsis and community-acquired
pneumonia.
Sepsis
Sepsis
is defined as a life-threatening organ dysfunction caused by a dysregulated host response to infection. In January of 2020, a report
entitled; “Global, Regional, and National Sepsis Incidence and Mortality, 1990-2017: Analysis for the Global Burden of Disease
Study,” was published in the Journal Lancet. The publication reported 48.9 million cases of sepsis and 11 million deaths in
2017. In that same year, an estimated 20.3 million sepsis cases and 2.9 million deaths were among children younger than 5-years old.
The report included a reference that sepsis kills more people around the world than all forms of cancer combined. In the United States,
sepsis was reported to be the most common cause of hospital deaths with an annual financial burden that exceeds $24 billion.
To
date, more than 100 human studies have been conducted to evaluate the safety and efficacy of candidate drugs to treat sepsis. With one
brief exception (Xigris, Eli Lilly), none of these studies resulted in a market cleared therapy. As sepsis remains beyond the reach of
single-target drugs, there is an emerging interest in multi-mechanism therapies that can target both inflammatory and pathogen associated
targets. Sigyn Therapy addresses a broad-spectrum of pathogen sources and the resulting dysregulated cytokine production (the cytokine
storm) that is the hallmark of sepsis. Additionally, we believe that inflammatory cytokine cargos transported by CytoVesicles may represent
a novel, yet important therapeutic target.
Community
Acquired Pneumonia
Community
Acquired Pneumonia (CAP) represents a significant opportunity for Sigyn Therapy to reduce the occurrence of sepsis. CAP is a leading
cause of death among infectious diseases, the leading cause of death in children under five years of age, and a catalyst for approximately
50% of sepsis and septic shock cases.
In
the United States, more than 1.5 million individuals are hospitalized with CAP each year, resulting in an annual financial burden that
exceeds $10 billion.
Statistically,
a therapeutic strategy that reduced the incidence of CAP related sepsis and septic shock would save thousands of lives each year. In
a study of 4,222 patients, the all-cause mortality for adult patients with CAP was reported to be 6.5% during hospitalization. However,
the mortality of patients with CAP related sepsis and septic shock rose to 51% during hospitalization.
CAP
is further complicated by the fact that the pathogen sources of CAP are identified in only 38% of patients, based on a study of 2,259
subjects whose pneumonia diagnosis was confirmed by chest x-ray. Of the source pathogens identified in the study, ninety seven percent
(97%) were either viral or bacterial in origin.
To
reduce the occurrence of CAP related sepsis and septic shock, Sigyn Therapy offers a broad-spectrum mechanism to reduce the circulating
presence of viral pathogens and bacterial toxins before and if they are identified as the CAP pathogen source. Additionally, Sigyn Therapy
may help to control the excess production of inflammatory cytokines (the cytokine storm) that precipitate sepsis and septic shock.
Emerging
Pandemic Threats
Covid-19
affirmed the use of extracorporeal blood purification as a first-line countermeasures to treat an emerging pandemic threat not addressed
with an approved drug or vaccine at the outset of an outbreak. On March 24, 2020, the U.S. Department of Health and Human Services (HHS)
declared that the emergence of COVID-19 justified the Emergency-Use Authorization (EUA) of drugs, biological products, and medical devices
to combat the pandemic. Within a month of this HHS declaration, FDA awarded an EUA to blood purification therapies from Terumo BCT, ExThera
Medical Corporation, CytoSorbents, Inc., and Baxter Healthcare Corporation. In connection with these authorizations, FDA published a
statement that blood purification devices may be effective at treating patients with confirmed COVID-19 by reducing various pathogens,
cytokines, and other inflammatory mediators from the bloodstream.
Consistent
with FDA’s statement, small-scale versions of Sigyn Therapy have been quantified to reduce the presence of various pathogens, cytokines,
and other inflammatory mediators from human blood plasma during in vitro studies. As such, we believe that Sigyn Therapy could
provide a candidate strategy to treat future pandemic outbreaks, which are increasingly being fuelled by a confluence of global warming,
urban crowding, and intercontinental travel.
Additionally,
as a majority of infectious human viruses are not addressed with a corresponding drug or vaccine, there may be an ongoing need for blood
purification technologies that offer to reduce the severity of infection and mitigate the excess production of inflammatory cytokines
(the cytokine storm) associated with high mortality in non-pandemic viral infections. In this regard, we believe Sigyn Therapy aligns
with HHS initiatives established through the Public Health Emergency Medical Countermeasure Enterprise (PHEMCE) that support the development
of broad-spectrum medical countermeasures that can mitigate the impact of an emerging pandemic or bioterror threat, yet also have viability
in established disease indications.
Candidate
Pipeline Product
Beyond
our focus to clinically advance Sigyn Therapy, we intend to develop a pipeline of extracorporeal blood purification therapies. In this
regard, we have designed a therapeutic system to enhance the benefit of cancer chemotherapy. To support this endeavor, we disclosed
on October 6, 2022, that a patent application entitled: “SYSTEM AND METHODS TO ENHANCE CHEMOTHERAPY DELIVERY AND REDUCE TOXICITY”
had been filed with the United States Patent and Trademark Office (“USPTO”). On October 13, 2022, we subsequently disclosed
that trademark applications to register ChemoPrepTM and ChemoPureTM were filed with the USPTO”.
Chemotherapeutic
agents are the most commonly administered drugs to treat cancer, which is the second leading cause of death in the United States. Despite
therapeutic advances, treatment toxicity, drug resistance and inadequate tumour site delivery restrict the benefit of chemotherapy. To
overcome these challenges, our patent submission describes a therapeutic device system whose primary objective is to enhance tumour site
delivery of chemotherapy and reduce its toxicity. A secondary objective of the system is to reduce treatment dosing without sacrificing
patient benefit, or conversely increase chemotherapy dosing without added toxicity. In concert with these objectives, our candidate therapeutic
system offers to inhibit the spread of cancer metastasis that can be induced by the administration of chemotherapy.
Our
proposed chemotherapy enhancement system is comprised of two blood purification technologies. ChemoPrepTM, administered prior
to chemotherapy to optimize tumour site delivery and improve the benefit of ChemoPureTM, which is deployed post-chemotherapy
to reduce treatment toxicity and inhibit the potential spread of cancer metastasis.
To
improve the delivery of chemotherapeutic agents, we designed ChemoPrepTM with an objective to reduce the bloodstream presence
of tumour-derived extracellular vesicles or exosomes (Tumor-EXs) that diminish the efficacy of chemotherapy. As compared to non-cancer
subjects, Tumor-EXs are highly concentrated in the bloodstream of those suffering from cancer. Tumor-EXs decoy and directly inhibit chemotherapeutic
agents from reaching tumour cell targets. Tumor-EXs have also been reported to export chemotherapeutic agents out of cancer cells. Based
on these factors, we believe the pre-chemo depletion of circulating Tumor-EXs could establish a novel, yet practical strategy to increase
tumour-site saturation of chemotherapy, which in turn may permit for lower doses of chemotherapy to be administered without diminishing
patient benefit.
ChemoPrepTM
may also improve the performance of ChemoPureTM as a reduced bloodstream presence of Tumor-EXs, which are competitive
binding and adsorption factors based on similar size and structural characteristics, would likely increase the efficiency of ChemoPureTM
to reduce the presence of off-target chemotherapeutic agents that remain circulating in the bloodstream.
ChemoPureTM
was designed to perform two critical functions after chemotherapy administration. To reduce treatment toxicity by lowering the
bloodstream presence of chemotherapeutic agents that are not delivered to the target tumour site, and to reduce the circulating presence
of chemotherapy-induced Tumor-EXs that may promote the spread of cancer metastases.
Unlike
Sigyn TherapyTM, which is a candidate to treat life-threatening conditions that are not addressed with approved drug therapies,
the intent of the ChemoPrepTM and ChemoPureTM is to enhance the delivery of market-cleared chemotherapeutic drugs
and reduce their toxicity. Additionally, while Sigyn TherapyTM is a hollow-fiber based device designed for use on dialysis
and continuous renal replacement machines, ChemoPrepTM and ChemoPureTM do not contain hollow-fibers and are intended
for use on portable blood processing systems that can be located within the clinical sites where chemotherapy is administered. During
treatment, the functionality of the blood processing system allows for patient blood plasma to flow through our devices, which contain
formulations of adsorbent and binding components intended deplete Tumor-EXs and chemotherapeutic agents from the bloodstream.
In
an in vitro study conducted by researchers at Innovative Biotherapies, we obtained pre-clinical insight that liposomal nanoparticles,
commonly used to deliver chemotherapeutic agents, can be reduced from human blood plasma with a formulation of adsorbent components.
In the study, liposome concentrations in human blood plasma were reduced by 92.5% after a two-hour interaction with the adsorbent components.
Beyond providing initial support for our candidate strategy to remove liposomal drug agents, the study established the possibility that
Tumor-EXs may also be reduced from blood plasma as liposomes have previously served as a research model system for isolating extracellular
vesicles and exosomes based on a similarity of size and structural characteristics.
Recent
Corporate Developments
| ● | December
2020 – Reported the first in vitro study results of Sigyn Therapy. The study
reported the simultaneous reduction of endotoxin, a gram-negative bacterial toxin, and relevant
pro-inflammatory cytokines from human blood plasma. The cytokines evaluated in the study
were Interleukin-1 Beta (IL-1B), Interleukin-6 (IL-6) and Tumor Necrosis Factor alpha (TNF-a). |
| | |
| ● | January
2021 - Reported the results of an in vitro study that modelled the potential of
Sigyn Therapy adsorbent components to reduce the presence of CytoVesicles (extracellular
vesicles that transport inflammatory cargos in the bloodstream) from human blood plasma. |
| | |
| ● | January
2021 - Appointed industry veteran Eric Lynam as Head of Clinical Affairs, with a mandate
to oversee clinical studies of Sigyn Therapy. |
| ● | April
2021 - Disclosed in vitro study observations that small-scale versions of Sigyn
Therapy were quantified to reduce the presence of viral pathogens, including SARS-CoV-2 (COVID-19)
from human blood plasma. |
| | |
| ● | April
2021 - Appointed former Aethlon Medical executive Charlene Owen as Director of Operations. |
| | |
| ● | July
2021 - Disclosed the completion of in vitro studies that quantified the reduction
of hepatic toxins (ammonia, bile acid & bilirubin) from human blood plasma with small-scale
versions of Sigyn Therapy. |
| | |
| ● | July
2021 - Disclosed the completion of a first-in-mammal pilot animal study of Sigyn Therapy
at the University of Michigan. |
| | |
| ● | December
2021 - Reported that small-scale versions of Sigyn Therapy reduced the presence of gram-positive
bacterial toxins from human blood plasma. |
| | |
| ● | February
2022 - Reported the subsequent completion of an in vivo animal study of Sigyn
Therapy at the University of Michigan. |
| | |
| ● | March
2022 - Appointed Jeremy Ferrell, CPA, MBA as Chief Financial Officer. |
| | |
| ● | March
2022 - Announced the appointments of two internationally recognized clinician researchers,
Alexander S. Yevzlin, MD, FASN and H. David Humes, MD, to Sigyn Therapeutics’ Scientific
Advisory Board. |
| | |
| ● | March
2022 - Ajay Verma, MD, PhD, a recognized thought leader in the field of neurology joins
the Scientific Advisory Board. |
| | |
| ● | April
2022 - Donald J. Hillebrand, M.D., a recognized thought leader in the field of Hepatology
and Liver Transplantation joins the Scientific Advisory Board. |
| | |
| ● | August
2022 – The Company’s common stock commences trading on the OTCQB Venture
Market. |
| | |
| ● | October
2022 – |
| ● | Announced
the appointment of Richa Nand, B.S., J.D.; Jim Dorst, B.S., M.S.; and Christopher Wetzel,
B.S., M.B.A. to our Board of Directors. |
| | |
| ● | Patent
application entitled: “SYSTEM AND METHODS TO ENHANCE CHEMOTHERAPY DELIVERY AND REDUCE
TOXICITY” is submitted to the United States Patent and Trademark Office (“USPTO”). |
| | |
| ● | Trademark
applications to register ChemoPrepTM and ChemoPureTM are filed with
the USPTO related to medical device products to enhance cancer therapies. |
Marketing
and Sales
At
present, our primary focus is the clinical and regulatory advancement of Sigyn Therapy. As such, we do not market or sell any therapeutic
products at this time. However, we plan to forge relationships with organizations that have established distribution channels into markets
that may have a demand for Sigyn Therapy should it receive market clearance from FDA or other foreign regulatory agencies.
Intellectual
Property
We
own the intellectual property rights to pending royalty-free patents that have been assigned to us by our co-founders, James A. Joyce
and Craig P. Roberts. We have also received a “Notice of Allowance” from the United States Patent and Trademark Office (USPTO)
related to the use of Sigyn Therapeutics, Sigyn Therapy, and the protection of our corporate logo. We plan to continually expand our
intellectual property portfolio and protect trade secrets that are not the subject of patent submissions. However, there is no assurance
that the claims of current pending and future patent applications will result in issued patents. Pending changes in patent law, it is
anticipated that each patent that becomes issued will have an enforceable life that will extend for a period of 20 years from the initial
patent filing date and will expire at the end of such 20-year terms.
At
present, we own the rights to the following patents pending.
DEVICES,
SYSTEMS AND METHODS FOR THE BROAD-SPECTRUM REDUCTION OF PRO-INFLAMMATORY CYTOKINES IN BLOOD - U.S. Application No.: 62/881,740; Filing
Date: 2019-08-01 - Inventors: Joyce and Roberts
DEVICES,
SYSTEMS AND METHODS FOR THE BROAD-SPECTRUM REDUCTION OF PRO-INFLAMMATORY CYTOKINES IN BLOOD - International Patent Application No.: PCT/US2020/044223;
Filing Date: 2020-07-30 - Inventors: Joyce and Roberts
DEVICES,
SYSTEMS AND METHODS FOR THE BROAD-SPECTRUM REDUCTION OF PRO-INFLAMMATORY CYTOKINES IN BLOOD - U.S. Patent Application No.: 16/943,436;
Filing Date: 2020-07-30 - Inventors: Joyce and Roberts
DEVICES,
SYSTEMS AND METHODS FOR THE BROAD-SPECTRUM REDUCTION OF PRO-INFLAMMATORY CYTOKINES IN BLOOD - EP No.: 20757445; Filing Date: 2022-01-24
- Inventors: Joyce and Roberts
DEVICES,
SYSTEMS AND METHODS FOR THE BROAD-SPECTRUM REDUCTION OF PRO-INFLAMMATORY CYTOKINES IN BLOOD - CA No.: 3148773; Filing Date: 2022-01-25
- Inventors: Joyce and Roberts
DEVICES,
SYSTEMS AND METHODS FOR THE BROAD-SPECTRUM REDUCTION OF PRO-INFLAMMATORY CYTOKINES IN BLOOD - JP No.: 2022-506670; Filing Date: 2022-01-31
- Inventors: Joyce and Roberts
EXTRA-LUMEN
ADSORPTION OF VIRAL PATHOGENS FROM BLOOD U.S. Patent Application No.: 63/177,520; Filing Date: 2021-04-21 Inventor: James A. Joyce
SYSTEM
AND METHODS TO ENHANCE CHEMOTHERAPY DELIVERY AND REDUCE TOXICITY U.S. Patent Application No.: 63/410,764; Filing Date: 09/28/2022 Inventor:
James A. Joyce
Government
Regulation
In
the United States, Sigyn Therapy is subject to regulation by the FDA. Should we seek to commercialize Sigyn Therapy outside the United
States, we expect to face comparable international regulatory oversight. The U.S. regulatory jurisdiction for extracorporeal blood purification
therapies is the Center for Devices and Radiological Health (“CDRH”), the FDA branch that oversees the market approval of
medical devices.
Based
on published CDRH guidance, we believe that Sigyn Therapy will be classified as a Class III medical device that is subject to a Pre-Market
Approval (“PMA”) submission pathway. A PMA pathway requires extensive data, including but not limited to technical documents,
preclinical studies, animal studies, human clinical trials, the establishment of Current Good Manufacturing Practices (“cGMPs”)
standards and labelling that fulfils FDA’s requirement to demonstrate reasonable evidence of safety and effectiveness of a medical
device product. However, as Sigyn Therapy does not emit electronic product radiation, it will not be subject to regulatory challenges
associated with medical devices that emit electronic radiation.
The
commercialization of medical devices in the United States requires either a prior 510(k) clearance, unless it is exempt, or a PMA from
the FDA. Generally, if a new device has a predicate that is already on the market under a 510(k) clearance, the FDA will allow that new
device to be marketed under a 510(k) clearance; otherwise, a premarket approval, or PMA, is required. Medical devices are classified
into one of three classes; Class I, Class II or Class III which are determined by the degree of risk associated with each medical device
and the extent of control needed to provide reasonable assurance of safety and effectiveness. Class I devices are deemed to be low risk
and are subject to the general controls of the Federal Food, Drug and Cosmetic Act, such as provisions that relate to: adulteration;
misbranding; registration and listing; notification, including repair, replacement, or refund; records and reports; and good manufacturing
practices. Most Class I devices are classified as exempt from pre-market notification under section 510(k) of the FD&C Act, and therefore
may be commercially distributed without obtaining 510(k) clearance from the FDA. Class II devices are subject to both general controls
and special controls to provide reasonable assurance of safety and effectiveness. Special controls include performance standards, post
market surveillance, patient registries and guidance documents. A manufacturer may be required to submit to the FDA a pre-market notification
requesting permission to commercially distribute some Class II devices. Devices deemed by the FDA to pose the greatest risk, such as
life-sustaining, life-supporting or implantable devices, or devices deemed not substantially equivalent to a previously cleared 510(k)
device, are placed in Class III. A Class III device cannot be marketed in the United States unless the FDA approves the device after
submission of a PMA. We believe that Sigyn Therapy will be classified as a Class III device and as such will be subject to a PMA submission
and approval.
Should
Sigyn Therapy receive market clearance from FDA, we would need to comply with applicable laws and regulations that govern the development,
testing, manufacturing, labeling, marketing, storage, distribution, advertising and promotion, and post-marketing surveillance reporting
for medical devices. Failure to comply with these applicable requirements may subject a device and/or its manufacturer to a variety of
administrative sanctions, such as issuance of warning letters, import detentions, civil monetary penalties and/or judicial sanctions,
such as product seizures, injunctions and criminal prosecution. Our failure to comply with any of these laws and regulations could have
a material adverse effect on our operations.
The
Pre-market Approval Pathway
A
pre-market approval (PMA) application must be submitted to the FDA for Class III devices for which FDA requires a PMA. The PMA application
process is much more demanding than the 510(k)-pre-market notification process. A PMA application must be supported by extensive data,
including but not limited to technical, preclinical, clinical trials, manufacturing and labeling to demonstrate to the FDA’s satisfaction
reasonable evidence of safety and effectiveness of the device.
After
a PMA application is submitted, the FDA has 45 days to determine whether the application is sufficiently complete to permit a substantive
review and thus whether the FDA will file the application for review. The FDA has 180 days to review a filed PMA application, although
the review of an application generally occurs over a significantly longer period of time and can take up to several years. During this
review period, the FDA may request additional information or clarification of the information already provided. Also, an advisory panel
of experts from outside the FDA may be convened to review and evaluate the application and provide recommendations to the FDA as to the
approvability of the device.
Although
the FDA is not bound by the advisory panel decision, the panel’s recommendations are important to the FDA decision making process.
In addition, the FDA may conduct a preapproval inspection of the manufacturing facility to ensure compliance with the Quality System
Regulation, or QSR. The agency also may inspect one or more clinical sites to assure compliance with FDA’s regulations.
Upon
completion of the PMA review, the FDA may: (i) approve the PMA which authorizes commercial marketing with specific prescribing information
for one or more indications, which can be more limited than those originally sought; (ii) issue an approvable letter which indicates
the FDA’s belief that the PMA is approvable and states what additional information the FDA requires, or the post-approval commitments
that must be agreed to prior to approval; issue a not approvable letter which outlines steps required for approval, but which are typically
more onerous than those in an approvable letter, and may require additional clinical trials that are often expensive and time consuming
and can delay approval for months or even years; or (iv) deny the application. If the FDA issues an approvable or not approvable letter,
the applicant has 180 days to respond, after which the FDA’s review clock is reset.
Clinical
Trials
Clinical
trials are almost always required to support PMA market clearance and are sometimes required for 510(k) clearance. In the United States,
for significant risk Class III devices, these trials require submission of an Investigational Device Exemption (IDE) application to the
FDA. The IDE application must be supported by appropriate data, such as animal and laboratory testing results, showing it is safe to
test the device in humans and that the testing protocol is scientifically sound. The IDE must be approved in advance by the FDA for a
specific number of patients at specified study sites. During the trial, the sponsor must comply with the FDA’s IDE requirements
for investigator selection, trial monitoring, reporting and record keeping. The investigators must obtain patient informed consent, rigorously
follow the investigational plan and study protocol, control the disposition of investigational devices and comply with all reporting
and record keeping requirements. Clinical trials for Class III devices may not begin until the IDE application is approved by the FDA
and the appropriate institutional review boards, or IRBs, at the clinical trial sites. An IRB is an appropriately constituted group that
has been formally designated to review and monitor medical research involving subjects and which has the authority to approve, require
modifications in, or disapprove research to protect the rights, safety and welfare of human research subjects. The FDA or the IRB at
each site at which a clinical trial is being performed may withdraw approval of a clinical trial at any time for various reasons, including
a belief that the risks to study subjects outweigh the benefits or a failure to comply with FDA or IRB requirements. Even if a trial
is completed, there is no assurance that clinical testing will demonstrate the safety and effectiveness of Sigyn Therapy or other pipeline
devices.
Manufacturing
and Procurement
We
are advancing a manufacturing relationship with an FDA registered Contract Manufacturing Organization (CMO) to establish cGMPs compliant
manufacturing to support human clinical studies and potential commercialization should we receive clearance to market Sigyn Therapy.
We plan to establish manufacturing procedure specifications that define each stage of our manufacturing, inspection and testing processes
and the control parameters or acceptance criteria that apply to each activity that result in the production of our technology.
We
have also established relationships with industry vendors that provide components necessary to manufacture our device. Should the relationship
with an industry vendor be interrupted or discontinued, we believe that alternate component suppliers can be identified to support the
continued manufacturing of our product. However, delays related to interrupted or discontinued vendor relationships could adversely impact
our business.
Research
and Product Development
To
date, we have outsourced our research and product development activities, which include the performance of in vitro blood plasma
validation studies, animal studies, pre-cGMPs product assembly and manufacturing through third party organizations with experience in
advancing extracorporeal blood purification technologies. Our pre-clinical in vitro blood plasma studies we each performed under
an agreement with Innovative BioTherapies, Inc. (IBT) and our animal clinical studies were conducted by IBT team members through a contract
with the University of Michigan to utilize animal care, associated institutional review oversight, as well as surgical suite facilities
located within the North Campus Research Complex. While we maintain ownership rights to all study data collected by IBT, we do permit
for IBT to publish or present the results of our contracted studies. At present, we do not have plans to build and staff our own research
and product development facility.
Environmental
Laws and Regulations
At
present, our operations are not subject to any environmental laws or regulations.
Employees
As
of the date of this filing, we have 4 salaried employees, whose benefits include paid medical, dental, and vision coverage. We also provide
our employees with access to a 401(k) plan, and we anticipate the establishment of an employee equity-stock option plan during the 2023
calendar year. To maintain a manageable employee headcount, we utilize non-employee consultants to perform as-needed services and we
contract with third party research organizations to perform studies designed to support the potential clinical advancement of Sigyn Therapy.
Available
Information
We
file various reports with the SEC, including Annual Reports on Form 10-K, Quarterly Reports on Form 10-Q and Current Reports on Form
8-K, which are available through the SEC’s electronic data gathering, analysis and retrieval system (“EDGAR”) by accessing
the SEC’s home page (http://www.sec.gov). The documents are also available to be read or copied at the SEC’s Public Reference
Room located at 100 F Street, NE, Washington, D.C., 20549. Information on the Public Reference Room may be obtained by calling the SEC
at 1-800-SEC-0330.
Item
1A. Risk Factors
This
item is not applicable because we are a “smaller reporting company” as defined in Exchange Act Rule 12b-2.
Item
1B. Unresolved Staff Comments
Not
applicable.
Item
2. Properties
Our
corporate address is 2468 Historic Decatur Road, Suite 140, San Diego, California, 92106.
We
believe that our existing facilities are adequate for our current needs and that we will be able to lease suitable additional or alternative
space on commercially reasonable terms if and when we need it.
Item
3. Legal Proceedings
From
time to time, we may become party to litigation or other legal proceedings that we consider to be a part of the ordinary course of our
business. We are not currently involved in legal proceedings that could reasonably be expected to have a material adverse effect on our
business, prospects, financial condition or results of operations. We may become involved in material legal proceedings in the future.
To the best our knowledge, none of our directors, officers or affiliates is involved in a legal proceeding adverse to our business or
has a material interest adverse to our business.
Item
4. Mine Safety Disclosures
There
is no information required to be disclosed by us under this Item.
PART
II
Item
5. Market for Registrant’s Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities
(a)
Market Information
Our
stock is quoted on the OTC markets under the symbol “SIGY.” There are 42,713,325 shares outstanding
as of March 31, 2023.
(b)
Transfer Agent
The
transfer agent and registrar for our common stock is VStock Transfer, LLC located at 18 Lafayette Place, Woodmere, New York.
(b)
Shareholders of Record
The
number of beneficial holders of record of our common stock as of the close of business on December 31, 2022 was 108.
(c)
Dividends
We
do not expect to pay cash dividends in the next term. We intend to retain future earnings, if any, to provide funds for operation of
our business. We currently have no restrictions affecting our ability to pay cash dividends.
(d)
Equity Compensation Plans
The
Company does not have an equity compensation plan.
Recent
Sales of Unregistered Securities
On
November 23, 2022, third party investor elected to convert the aggregate principal amount of the Note, $145,200, into 968,000 common
shares.
Item
6. Selected Financial Data
Because
we are a smaller reporting company, this Item 6 is not applicable.
Item
7. Management’s Discussion and Analysis of Financial Condition and Results of Operations
You
should read the following discussion and analysis of our financial condition and results of operations together with our consolidated
financial statements and related notes included elsewhere in this filing. This discussion and other parts of this filing contain forward-looking
statements that involve risk and uncertainties, such as statements of our plans, objectives, expectations, intentions, and beliefs. Our
actual results may differ materially from those discussed in these forward-looking statements as a result of various factors, including
those set forth under “Risk Factors” and in other parts of this filing, and you should not place undue certain on these forward-looking
statements, which apply only as of the date of this filing. See “Disclosure Regarding Forward-Looking Statements”.
We
are an emerging growth company as defined in Section 2(a) (19) of the Securities Act. Pursuant to Section 107 of the Jumpstart Our Business
Startups Act, we may take advantage of the extended transition period provided in Section 7(a)(2)(B) of the Securities Act for complying
with new or revised accounting standards, meaning that we can delay the adoption of certain accounting standards until those standards
would otherwise apply to private companies. We have chosen to take advantage of the extended transition period for complying with new
or revised accounting standards applicable to public companies to delay adoption of such standards until such standards are made applicable
to private companies. Accordingly, our consolidated financial statements may not be comparable to the financial statements of public
companies that comply with such new or revised accounting standards.
OVERVIEW:
Historical
Development
Our
Company
Sigyn
Therapeutics, Inc. (“Sigyn”, the “Company”, “we,” “us,” or “our”) is a development-stage
company focused on creating therapeutic solutions that address unmet needs in global health. Our corporate address is 2468 Historic Decatur
Road, Suite 140, San Diego, California, 92106.
Sigyn
Therapy™, our lead product candidate, is a broad-spectrum blood purification technology designed to treat pathogen-associated inflammatory
disorders that are not addressed with approved drug therapies. Candidate treatment indications include endotoxemia and inflammation in
end-stage renal disease (dialysis) patients, sepsis (a leading cause of hospital deaths), community acquired pneumonia (a leading cause
of death among infectious diseases), and emerging pandemic threats.
Our
development pipeline includes a cancer treatment system comprised of ChemoPrep™ to enhance the tumor site delivery of chemotherapy,
and ChemoPure™ to reduce treatment toxicity and inhibit the spread of cancer metastasis.
Financing
Transactions
Preferred
Stock
The
Company has 10,000,000 shares of par value $0.0001 preferred stock authorized, of which no preferred shares are issued and outstanding
at December, 31, 2022.
Common
Stock
The
Company has authorized 1,000,000,000 shares of par value $0.0001 common stock, of which 42,713,325 shares were outstanding as of December
31, 2022.
On
November 23, 2022, an investor elected to convert the aggregate principal amount of the Note, $145,200, into 968,000 common shares.
On
October 28, 2021, an investor elected to convert $16,714 of the aggregate principal amount of the Note of $199,650, into 42,857 common
shares.
On
October 25, 2021, an investor elected to convert the aggregate principal amount of the Note, $110,000, into 157,143 common shares.
On
October 20, 2021, the Company entered into a securities purchase agreement with an accredited investor that resulted in the issuance
of 320,000 shares of common stock and warrants to purchase an aggregate of 320,000 shares of the Company’s common stock for total
proceeds totaling $400,000. The offering allowed for qualified investors to purchase one share of the Company’s common stock at
$1.25. For each share purchased, the investor received a five-year warrant to purchase one share of common stock at $1.25 per share.
No commissions were paid in the offering. This issuance was pursuant to Section 4(a)(2) of the Securities Act in a transaction exempt
from registration.
On
October 14, 2021, the Company issued a total of 47,000 shares of its common stock valued at $37,600 (based on the stock price of the
Company’s common stock on the date of issuance) to a third party, for communications to the financial industry.
On
July 14, 2021, the Company issued a total of 47,000 shares of its common stock valued at $47,000 (based on the stock price of the Company’s
common stock on the date of issuance) to a third party, for communications to the financial industry.
On
May 10, 2021, Brio Capital elected to convert the aggregate principal amount of a $110,000 convertible note issued on February 10, 2021
into 157,143 shares of the Company’s common stock.
In
April 2021, the Company initiated an offering of up to $1.5 million of the Company’s restricted common shares. The offering allowed
for qualified investors to purchase one share of the Company’s common stock $1.25. For each share purchased, the investor received
a five-year warrant to purchase one share of common stock at $1.75 per share. On May 10, 2021, the Company closed the offering to investors
and subsequently disclosed that it had entered into securities purchase agreements with accredited investors that resulted in the issuance
of 1,172,000 shares of common stock and warrants to purchase an aggregate of 1,172,000 shares of the Company’s common stock for
total proceeds totaling $1,465,000. No commissions were paid in the offering. This issuance was pursuant to Section 4(a)(2) of the Securities
Act in a transaction exempt from registration.
On
April 14, 2021, the Company issued a total of 47,000 shares of its restricted common stock valued at $82,250 (based on the stock price
of the Company’s common stock on the date of issuance) to a third party, for communications to the financial industry. This issuance
was pursuant to Section 4(a) (2) of the Securities Act in a transaction exempt from registration.
On
February 19, 2021, a previous noteholder exercised the warrants pursuant to the cashless exercise provision of the warrant agreement
into 57,147 common shares. The common shares have not been issued as of March 14, 2022.
On
January 14, 2021, the Company issued a total of 47,000 shares of its restricted common stock valued at $82,250 (based on the stock price
of the Company’s common stock on the date of issuance) to a third party, for communications to the financial industry. This issuance
was pursuant to Section 4(a)(2) of the Securities Act in a transaction exempt from registration.
Warrants
On
October 22, 2021, the Company and Osher amended convertible debt agreements for the maturity date from October 20, 2021 to October 20,
2022. In exchange for the extension of the Note, the Company issued Osher 450,000 warrants to purchase an aggregate of 450,000 shares
of the Company’s common stock, valued at $197,501 (based on the Black Scholes valuation model on the date of grant) (see Note 6).
The warrants are exercisable for a period of five years at $1.00 per share in whole or in part, as either a cash exercise or as a cashless
exercise, and fully vest at grant date. The Company accreted the value of the warrants rateably through October 20, 2022. The Company
recorded $147,720 and $40,041 for the years ended December 31, 2022 and 2021, respectively, and is classified in other expenses in the
consolidated Statements of Operations.
In
March 2023, the Company offered a short-term inducement to the Company’s warrant holders in which the Company will issue one share
of the Company’s common stock in exchange for each two warrants returned to the Company to be cancelled. All other terms of the
original grants remain the same. A total of 8,899,019 warrants were exchanged for 4,449,512 shares of the Company’s common stock
through March 24, 2023.
Current
Noteholders
2023 Convertible Notes
During the three months ended March 31, 2023, the
Company entered into an Original Issue Discount Senior Convertible Debentures totaling (i) $970,200
aggregate principal amount of Note (total of $882,000 cash was received) due in various dates in January through March 2024 based on $1.00
for each $0.90909 paid by the previous noteholder and (ii) five-year Common Stock Purchase Warrants (“Warrants’) to purchase
up to an aggregate of 6,468,004 shares of the Company’s Common Stock at an exercise price of $0.25 per share. The
conversion price for the principal in connection with voluntary conversions by the holders of the convertible notes is $0.15 per share.
Osher
– $110,000
On
December 22, 2022, the Company entered into an Original Issue Discount Senior Convertible Debenture (the “Note”) with respect
to the sale and issuance to institutional investor Osher Capital Partners LLC (“Osher”)
of (i) $110,000 aggregate principal amount of Note due December 22, 2023 based on $1.00 for each $0.90909 paid by Osher noteholder and
(ii) five-year Common Stock Purchase Warrants (“Warrants’) to purchase up to an aggregate of 733,333 shares of the Company’s
Common Stock at an exercise price of $0.25 per share. The aggregate cash subscription amount received by the Company from Osher for the
issuance of the Note and Warrants was $100,000 which was issued at a $10,000 original issue discount from the face value of the Note.
The conversion price for the principal in connection with voluntary conversions by a holder of
the convertible notes is $0.15 per share, subject to adjustment as provided therein, such as stock splits and stock dividends.
Osher
– $55,000
On
November 14, 2022, the Company entered into an Original Issue Discount Senior Convertible Debenture (the “Note”) with respect
to the sale and issuance to institutional investor Osher Capital Partners LLC (“Osher”)
of (i) $55,000 aggregate principal amount of Note due November 14, 2023 based on $1.00 for each $0.90909 paid by Osher and (ii) five-year
Common Stock Purchase Warrants (“Warrants’) to purchase up to an aggregate of 366,667 shares of the Company’s Common
Stock at an exercise price of $0.25 per share. The aggregate cash subscription amount received by the Company from Osher for the issuance
of the Note and Warrants was $50,000 which was issued at a $5,000 original issue discount from the face value of the Note. The
conversion price for the principal in connection with voluntary conversions by a holder of the convertible notes is $0.15 per share,
subject to adjustment as provided therein, such as stock splits and stock dividends.
Brio
– $82,500
On
November 9, 2022, the Company entered into an Original Issue Discount Senior Convertible Debenture (the “Note”) with respect
to the sale and issuance to institutional investor Brio Capital Master Fund Ltd (“Brio”)
of (i) $82,500 aggregate principal amount of Note due November 9, 2023 based on $1.00 for each $0.90909 paid by Brio and (ii) five-year
Common Stock Purchase Warrants (“Warrants’) to purchase up to an aggregate of 550,000 shares of the Company’s Common
Stock at an exercise price of $0.25 per share. The aggregate cash subscription amount received by the Company from Brio for the issuance
of the Note and Warrants was $75,000 which was issued at a $7,500 original issue discount from the face value of the Note. The
conversion price for the principal in connection with voluntary conversions by a holder of the convertible notes is $0.15 per share,
subject to adjustment as provided therein, such as stock splits and stock dividends.
Osher
– $110,000
On
October 20, 2022, the Company entered into an Original Issue Discount Senior Convertible Debenture (the “Note”) with respect
to the sale and issuance to institutional investor Osher Capital Partners LLC (“Osher”)
of (i) $110,000 aggregate principal amount of Note due October 20, 2023 based on $1.00 for each $0.90909 paid by Osher and (ii) five-year
Common Stock Purchase Warrants (“Warrants’) to purchase up to an aggregate of 733,333 shares of the Company’s Common
Stock at an exercise price of $0.25 per share. The aggregate cash subscription amount received by the Company from Osher for the issuance
of the Note and Warrants was $100,000 which was issued at a $10,000 original issue discount from the face value of the Note. The
conversion price for the principal in connection with voluntary conversions by a holder of the convertible notes is $0.15 per share,
subject to adjustment as provided therein, such as stock splits and stock dividends.
Osher
– $110,000
On
September 20, 2022, the Company entered into an Original Issue Discount Senior Convertible Debenture (the “Note”) with respect
to the sale and issuance to institutional investor Osher Capital Partners LLC (“Osher”)
of (i) $110,000 aggregate principal amount of Note due September 20, 2023 based on $1.00 for each $0.90909 paid by Osher and (ii) five-year
Common Stock Purchase Warrants (“Warrants’) to purchase up to an aggregate of 733,333 shares of the Company’s Common
Stock at an exercise price of $0.25 per share. The aggregate cash subscription amount received by the Company from Osher for the issuance
of the Note and Warrants was $100,000 which was issued at a $10,000 original issue discount from the face value of the Note. The
conversion price for the principal in connection with voluntary conversions by a holder of the convertible notes is $0.15 per share,
subject to adjustment as provided therein, such as stock splits and stock dividends.
Brio
– $82,500
On
September 9, 2022, the Company entered into an Original Issue Discount Senior Convertible Debenture (the “Note”) with respect
to the sale and issuance to institutional investor Brio Capital Master Fund Ltd. (“Brio”)
of (i) $82,500 aggregate principal amount of Note due September 9, 2023 based on $1.00 for each $0.90909 paid by Brio and (ii) five-year
Common Stock Purchase Warrants (“Warrants’) to purchase up to an aggregate of 550,000 shares of the Company’s Common
Stock at an exercise price of $0.25 per share. The aggregate cash subscription amount received by the Company from Brio for the issuance
of the Note and Warrants was $75,000 which was issued at a $7,500 original issue discount from the face value of the Note. The
conversion price for the principal in connection with voluntary conversions by a holder of the convertible notes is $0.15 per share,
subject to adjustment as provided therein, such as stock splits and stock dividends.
Osher
– $110,000
On
August 31, 2022, the Company entered into an Original Issue Discount Senior Convertible Debenture (the “Note”) with respect
to the sale and issuance to institutional investor Osher Capital Partners LLC (“Osher”)
of (i) $110,000 aggregate principal amount of Note due August 31, 2023 based on $1.00 for each $0.90909 paid by Osher and (ii) five-year
Common Stock Purchase Warrants (“Warrants’) to purchase up to an aggregate of 733,333 shares of the Company’s Common
Stock at an exercise price of $0.25 per share. The aggregate cash subscription amount received by the Company from Osher for the issuance
of the Note and Warrants was $100,000 which was issued at a $10,000 original issue discount from the face value of the Note. The
conversion price for the principal in connection with voluntary conversions by a holder of the convertible notes is $0.15 per share,
subject to adjustment as provided therein, such as stock splits and stock dividends.
Other
– $341,000
In
July 2022, the Company entered into an Original Issue Discount Senior Convertible Debentures (the “July 2022 Notes”) totalling
(i) $341,000 aggregate principal amount of Note (total of $310,000 cash was received) due in various dates in July 2023 based on $1.00
for each $0.90909 paid by Osher and (ii) five-year Common Stock Purchase Warrants (“Warrants’) to purchase up to an aggregate
of 676,936 shares of the Company’s Common Stock at an exercise price of $0.50 per share. The
conversion price for the principal in connection with voluntary conversions by the holders of the convertible notes is $0.50 per share.
Osher
– $82,500
On
June 22, 2022, the Company entered into an Original Issue Discount Senior Convertible Debenture (the “Note”) with respect
to the sale and issuance to institutional investor Osher Capital Partners LLC (“Osher”)
of (i) $82,500 aggregate principal amount of Note due June 22, 2023 based on $1.00 for each $0.90909 paid by Osher and (ii) five-year
Common Stock Purchase Warrants (“Warrants’) to purchase up to an aggregate of 165,000 shares of the Company’s Common
Stock at an exercise price of $0.50 per share. The aggregate cash subscription amount received by the Company from Osher for the issuance
of the Note and Warrants was $75,000 which was issued at a $7,500 original issue discount from the face value of the Note. The
conversion price for the principal in connection with voluntary conversions by a holder of the convertible notes is $0.50 per share,
subject to adjustment as provided therein, such as stock splits and stock dividends.
Osher
– $55,000
On
June 1, 2022, the Company entered into an Original Issue Discount Senior Convertible Debenture (the “Note”) with respect
to the sale and issuance to institutional investor Osher Capital Partners LLC (“Osher”)
of (i) $55,000 aggregate principal amount of Note due June 1, 2023 based on $1.00 for each $0.90909 paid by Osher and (ii) five-year
Common Stock Purchase Warrants (“Warrants’) to purchase up to an aggregate of 110,000 shares of the Company’s Common
Stock at an exercise price of $0.50 per share. The aggregate cash subscription amount received by the Company from Osher for the issuance
of the Note and Warrants was $50,000 which was issued at a $5,000 original issue discount from the face value of the Note. The
conversion price for the principal in connection with voluntary conversions by a holder of the convertible notes is $0.50 per share,
subject to adjustment as provided therein, such as stock splits and stock dividends.
Brio
– $110,000
On
May 10, 2022, the Company entered into an Original Issue Discount Senior Convertible Debenture (the “Note”) with respect
to the sale and issuance to institutional investor Brio Capital Master Fund Ltd. (“Brio”)
of (i) $110,000 aggregate principal amount of Note due May 10, 2023 based on $1.00 for each $0.90909 paid by Brio and (ii) five-year
Common Stock Purchase Warrants (“Warrants’) to purchase up to an aggregate of 220,000 shares of the Company’s Common
Stock at an exercise price of $0.50 per share. The aggregate cash subscription amount received by the Company from Brio for the issuance
of the Note and Warrants was $100,000 which was issued at a $10,000 original issue discount from the face value of the Note. The
conversion price for the principal in connection with voluntary conversions by a holder of the convertible notes is $0.50 per share,
subject to adjustment as provided therein, such as stock splits and stock dividends.
Osher
– $110,000
On
April 28, 2022, the Company entered into an Original Issue Discount Senior Convertible Debenture (the “Note”) with respect
to the sale and issuance to institutional investor Osher Capital Partners LLC (“Osher”)
of (i) $110,000 aggregate principal amount of Note due April 28, 2023 based on $1.00 for each $0.90909 paid by Osher and (ii) five-year
Common Stock Purchase Warrants (“Warrants’) to purchase up to an aggregate of 220,000 shares of the Company’s Common
Stock at an exercise price of $0.50 per share. The aggregate cash subscription amount received by the Company from Osher for the issuance
of the Note and Warrants was $100,000 which was issued at a $10,000 original issue discount from the face value of the Note. The
conversion price for the principal in connection with voluntary conversions by a holder of the convertible notes is $0.50 per share,
subject to adjustment as provided therein, such as stock splits and stock dividends.
Osher
– $110,000
On
March 23, 2022, the Company entered into an Original Issue Discount Senior Convertible Debenture (the “Note”) with respect
to the sale and issuance to institutional investor Osher Capital Partners LLC (“Osher”)
of (i) $110,000 aggregate principal amount of Note due March 23, 2023 based on $1.00 for each $0.90909 paid by Osher and (ii) five-year
Common Stock Purchase Warrants (“Warrants’) to purchase up to an aggregate of 220,000 shares of the Company’s Common
Stock at an exercise price of $0.50 per share. The aggregate cash subscription amount received by the Company from Osher for the issuance
of the Note and Warrants was $100,000 which was issued at a $10,000 original issue discount from the face value of the Note. The
conversion price for the principal in connection with voluntary conversions by a holder of the convertible notes is $0.50 per share,
subject to adjustment as provided therein, such as stock splits and stock dividends.
The
Company has not repaid this convertible note and the convertible note is now in default. The Company is currently in discussions to restructure
the terms of the note.
Brio
– $110,000
On
March 23, 2022, the Company entered into an Original Issue Discount Senior Convertible Debenture (the “Note”) with respect
to the sale and issuance to institutional investor Brio Capital Master Fund Ltd. (“Brio”)
of (i) $110,000 aggregate principal amount of Note due March 23, 2023 based on $1.00 for each $0.90909 paid by Brio and (ii) five-year
Common Stock Purchase Warrants (“Warrants’) to purchase up to an aggregate of 220,000 shares of the Company’s Common
Stock at an exercise price of $0.50 per share. The aggregate cash subscription amount received by the Company from Brio for the issuance
of the Note and Warrants was $100,000 which was issued at a $10,000 original issue discount from the face value of the Note. The
conversion price for the principal in connection with voluntary conversions by a holder of the convertible notes is $0.50 per share,
subject to adjustment as provided therein, such as stock splits and stock dividends.
The
Company has not repaid this convertible note and the convertible note is now in default. The Company is currently in discussions to restructure
the terms of the note.
Osher
– $199,650
On
September 17, 2020 (the “Original Issue Date”), the Company entered into a Securities Purchase Agreement (the “Purchase
Agreement”) with respect to the sale and issuance to institutional investor Osher Capital
Partners LLC (“Osher”) of (i) $181,500 aggregate principal amount of Original Issue Discount Senior Convertible Debenture
(the “Note”) due September 30, 2021, based on $1.00 for each $0.90909 paid by Osher and (ii) five-year Common Stock Purchase
Warrants (“Warrants’) to purchase up to an aggregate of 8,250 shares of the Company’s Common Stock at an exercise price
of $30.00 per share. The aggregate cash subscription amount received by the Company from Osher for the issuance of the Note and Warrants
was $165,000 which was issued at a $16,500 original issue discount from the face value of the Note. The
conversion price for the principal in connection with voluntary conversions by a holder of the convertible notes is $0.39 per share,
as amended on October 20, 2020, subject to adjustment as provided therein, such as stock splits and stock dividends.
The
Company and Osher amended the convertible debt agreement as follows on October 20, 2020:
|
● |
The
parties amended the Warrants dated September 17, 2020, for the number of warrant shares from 8,250 warrant shares to 465,366 warrant
shares at an exercise price of $0.59 per share. |
|
● |
The
parties amended the Note for the maturity date from September 30, 2021 to October 20, 2021. |
On
October 22, 2021, the Company and Osher amended convertible debt agreements as follows:
|
● |
The
parties amended the October 20, 2020 Notes for the maturity date from October 20, 2021 to October 20, 2022. |
|
|
|
|
● |
The
parties amended the October 20, 2020 Notes for the aggregate principal amount and accrued interest from $652,300 to $717,530 which
is issued at a $65,230 original issue discount from the face value of the October 20, 2020 Notes now due October 20, 2022. |
|
|
|
|
● |
In
exchange for the extension of the Note, the Company issued Osher five-year warrants to purchase an aggregate of 450,000 shares of
the Company’s common stock at an exercise price of $1.00 per share. |
On
October 28, 2021, Osher elected to convert $16,714 of the aggregate principal amount of the Note of $199,650, into 42,857 common shares.
The
Company has not repaid this convertible note and the convertible note is now in default. The Company is currently in discussions to restructure
the terms of the note.
Osher
– $60,500 (as amended on October 20, 2020 to $55,000)
On
June 23, 2020 (the “Original Issue Date”), the Company entered into a Securities Purchase Agreement (the “Purchase
Agreement”) with respect to the sale and issuance to institutional investor Osher Capital
Partners LLC (“Osher”) of (i) $50,000 aggregate principal amount of Original Issue Discount Senior Convertible Debenture
(the “Note”) due June 23, 2021, based on $1.00 for each $0.90909 paid by Osher and (ii) five-year Common Stock Purchase Warrants
(“Warrants”) to purchase up to an aggregate of 10,000 shares of the Company’s Common Stock at an exercise price of
$30.00 per share. The aggregate cash subscription amount received by the Company from Osher for the issuance of the Note and Warrants
was $50,005 which was issued at a $0 original issue discount from the face value of the Note. The
conversion price for the principal in connection with voluntary conversions by a holder of the convertible notes is $0.39 per share,
as amended on October 20, 2020, subject to adjustment as provided therein, such as stock splits and stock dividends.
The
Company and Osher amended the convertible debt agreement as follows on October 20, 2020:
|
● |
The
parties amended the Note for the aggregate principal amount from $50,000 to $55,000. The aggregate cash subscription amount received
by the Company from Osher for the issuance of the Note and Warrants was $50,005 which was issued at an amended $4,995 original issue
discount from the face value of the Note. |
|
● |
The
parties amended the Warrants dated June 23, 2020, for the number of warrant shares from 10,000 warrant shares to 141,020 warrant
shares at an exercise price of $0.59 per share. |
|
● |
The
parties amended the Note for the maturity date from June 23, 2021 to October 20, 2021. |
On
October 22, 2021, the Company and Osher amended convertible debt agreements as follows (see Note 12):
|
● |
The
parties amended the October 20, 2020 Notes for the maturity date from October 20, 2021 to October 20, 2022. |
|
|
|
|
● |
The
parties amended the October 20, 2020 Notes for the aggregate principal amount and accrued interest from $652,300 to $717,530 which
is issued at a $65,230 original issue discount from the face value of the October 20, 2020 Notes now due October 20, 2022. |
|
|
|
|
● |
In
exchange for the extension of the Note, the Company issued Osher five-year warrants to purchase an aggregate of 450,000 shares of
the Company’s common stock at an exercise price of $1.00 per share. |
The
Company has not repaid this convertible note and the convertible note is now in default. The Company is currently in discussions to restructure
the terms of the note.
Osher
– $457,380
On
January 28, 2020 (the “Original Issue Date”), the Company entered into a Securities Purchase Agreement (the “Purchase
Agreement”) with respect to the sale and issuance to institutional investor Osher Capital
Partners LLC (“Osher”) of (i) $385,000 aggregate principal amount of Original Issue Discount Senior Convertible Debenture
due January 26, 2021, based on $1.00 for each $0.90909 paid by Osher and (ii) five-year Common Stock Purchase Warrants to purchase up
to an aggregate of 80,209 shares of the Company’s Common Stock at an exercise price of $7.00 per share. The aggregate cash subscription
amount received by the Company from Osher for the issuance of the note and warrants was $350,005 which was issued at a $34,995 original
issue discount from the face value of the Note. The conversion price for the principal in connection
with voluntary conversions by a holder of the convertible notes is $0.094 per share, as amended on October 20, 2020, subject to adjustment
as provided therein, such as stock splits and stock dividends.
The
Company and Osher amended the convertible debt agreement as follows on October 20, 2020:
|
● |
The
parties amended the Warrants dated January 28, 2020, for the number of warrant shares from 80,209 warrant shares to 4,113,083 warrant
shares at an exercise price of $0.14 per share. |
|
● |
The
parties amended the Note to provide for interest at 8% per annum. |
|
● |
The
parties amended the Note for the maturity date from June 23, 2021 to October 20, 2021. |
On
October 22, 2021, the Company and Osher amended convertible debt agreements as follows:
|
● |
The
parties amended the October 20, 2020 Notes for the maturity date from October 20, 2021 to October 20, 2022. |
|
|
|
|
● |
The
parties amended the October 20, 2020 Notes for the aggregate principal amount and accrued interest from $652,300 to $717,530 which
is issued at a $65,230 original issue discount from the face value of the October 20, 2020 Notes now due October 20, 2022. |
|
|
|
|
● |
In
exchange for the extension of the Note, the Company issued Osher five-year warrants to purchase an aggregate of 450,000 shares of
the Company’s common stock at an exercise price of $1.00 per share. |
The
Company has not repaid this convertible note and the convertible note is now in default. The Company is currently in discussions to restructure
the terms of the note.
Previous
Noteholders
Other
– $145,200
On
November 21, 2022, the Company entered into an Original Issue Discount Senior Convertible Debenture (the “Note”) with a third
party investor of (i) $145,200 aggregate principal amount of Note due November 21, 2023 based on $1.00 for each $0.90909 paid by the
previous noteholder and (ii) five-year Common Stock Purchase Warrants (“Warrants’) to purchase up to an aggregate of 968,000
shares of the Company’s Common Stock at an exercise price of $0.25 per share. The aggregate cash subscription amount received by
the Company from the previous noteholder for the issuance of the Note and Warrants was $132,000 which was issued at a $13,200 original
issue discount from the face value of the Note. The conversion price for the principal in connection
with voluntary conversions by a holder of the convertible notes is $0.15 per share, subject to adjustment as provided therein,
such as stock splits and stock dividends.
On
November 23, 2022, third party investor elected to convert the aggregate principal amount of the Note, $145,200, into 968,000 common
shares.
All
other previous notes were detailed in our Form 10-K filed on March 31, 2022. No changes occurred related to these notes during the period
covered by this Form 10-Q.
Impairment
of Inventory
Based
on the significant advancement of Sigyn Therapy, the Company decided in the 4th quarter of 2021 to assess the value of retail
business operations that were a focus of the Company prior to the merger transaction consummated on October 19, 2020.
Related
to this assessment, management determined the wholesale liquidation value of its sapphire gem inventory to be 5-10% of the previously
reported retail value, based on communications with certified gemologists, the variance between retail and wholesale valuations, and
current market conditions. As a result, the Company has valued the inventory at $50,000 and recorded an impairment of assets of $536,047
in the year ended December 31, 2021 and is classified in other expenses in the consolidated Statements of Operations.
Limited
Operating History; Need for Additional Capital
There
is limited historical financial information about us on which to base an evaluation of our performance. We cannot guarantee we will be
successful in our business operations. Our business is subject to risks inherent in the establishment of a new business enterprise, including
limited capital resources, and possible cost overruns due to increases in the cost of services. To become profitable and competitive,
we must receive additional capital. We have no assurance that future financing will materialize. If that financing is not available,
we may be unable to continue operations.
Overview
of Presentation
The
following Management’s Discussion and Analysis (“MD&A”) or Plan of Operations includes the following sections:
|
● |
Results
of Operations |
|
|
|
|
● |
Liquidity
and Capital Resources |
|
|
|
|
● |
Capital
Expenditures |
|
|
|
|
● |
Going
Concern |
|
|
|
|
● |
Critical
Accounting Policies |
|
|
|
|
● |
Off-Balance
Sheet Arrangements |
General
and administrative expenses consist primarily of personnel costs and professional fees required to support our operations and growth.
Depending
on the extent of our future growth, we may experience significant strain on our management, personnel, and information systems. We will
need to implement and improve operational, financial, and management information systems. In addition, we are implementing new information
systems that will provide better record-keeping, customer service and billing. However, there can be no assurance that our management
resources or information systems will be sufficient to manage any future growth in our business, and the failure to do so could have
a material adverse effect on our business, results of operations and financial condition.
Reclassifications
An
adjustment has been made to the Consolidated Balance Sheets as of December 31, 2021, to reclass $1,072 of other current liabilities previously
classified in accrued payroll and payroll taxes. These reclassifications had no effect on the reported results of operations.
Results
of Operations
Year
Ended December 31, 2022 Compared to Year Ended December 31, 2021
The
following discussion represents a comparison of our results of operations for the years ended December 31, 2022 and 2021. The results
of operations for the periods shown in our audited consolidated financial statements are not necessarily indicative of operating results
for the entire period. In the opinion of management, the audited consolidated financial statements recognize all adjustments of a normal
recurring nature considered necessary to fairly state our financial position, results of operations and cash flows for the periods presented.
| |
Year Ended
December 31, 2022 | | |
Year Ended
December 31, 2021 | |
| |
| | |
| |
Net revenues | |
$ | - | | |
$ | - | |
Cost of sales | |
| - | | |
| - | |
Gross Profit | |
| - | | |
| - | |
Operating expenses | |
| 2,147,265 | | |
| 2,008,217 | |
Other expense | |
| 782,552 | | |
| 996,402 | |
Net loss before income taxes | |
$ | (2,929,817 | ) | |
$ | (3,004,619 | ) |
Net
Revenues
For
the years ended December 31, 2022 and 2021, we had no revenues.
Cost
of Sales
For
the years ended December 31, 2022 and 2021, we had no cost of sales.
Operating
expenses
Operating
expenses increased by $139,048, or 6.9%, to $2,147,265 for the year ended December 31, 2022 from $2,008,217 for the year ended December
31, 2021 primarily due to increases in professional fees of $86,093, compensation costs of $237,983, depreciation costs of $3,908, insurance
costs of $212,284, rent expenses of $30,105, and general and administration costs of $12,804, offset partially by consulting costs of
$79,369, research and development costs of $76,357, investor relations costs of $275,798, and amortization costs of $12,605, as a result
of adding administrative infrastructure for our anticipated business development. In 2022, the Company incurred an increase in professional
fees (primarily legal and audit fees), incurred a full year of compensation for its CEO and CTO and hired a CFO resulting in increased
compensation costs, increased consulting costs (primarily for public relations and brand awareness), has decreased investor relations
costs (primarily the fair value of common stock issued for services of $249,100 in 2021), and incurred a full year of rent from the lease
of office space in June 2021. Research and development costs consist of a decrease of $76,357 attributed to third parties for developmental
services of $100,211 offset partially by an increase in testing in house efforts of $23,854.
For
the year ended December 31, 2022, we had marketing expenses of $457, research and development costs of $657,657, and general and administrative
expenses of $1,489,151 primarily due to professional fees of $209,386, compensation costs of $689,717, consulting costs of $206,825,
insurance costs of $215,704, rent of $76,768, depreciation costs of $6,854, amortization costs of $3,600, investor relations costs of
$53,208, and general and administration costs of $27,546, as a result of adding administrative infrastructure for our anticipated business
development. In 2022, the Company has incurred professional fees (primarily legal and audit fees), incurred compensation for its CEO
and CTO and hired a CFO, incurred consulting costs (primarily for public relations and brand awareness), had investor relations costs,
and had rent through the lease of office space. Research and development costs consist of $579,977 attributed to in house efforts and
$77,680 to third parties for developmental services and testing.
For
the year ended December 31, 2021, we had research and development costs of $734,014, and general and administrative expenses of $1,274,203
primarily due to professional fees of $123,293, compensation costs of $451,734, consulting costs of $286,194, rent of $46,663, depreciation
and amortization costs of $19,151, investor relations costs of $329,006, and general and administration costs of $18,162, as a result
of adding administrative infrastructure for our anticipated business development. In 2021, the Company has incurred professional fees
(primarily legal and audit fees, and consulting costs), had investor relations costs (primarily the fair value of common stock issued
for services of $249,100), and incurred compensation for its CEO and CTO. Research and development costs consist of $556,123 attributed
to in house efforts and $177,891 to third parties for developmental services and testing.
Other
Expense
Other
expense for the year ended December 31, 2022 totaled $782,552 primarily due interest expense of $782,114 in conjunction with accretion
of debt discount and original issuance discount, and interest expense of $438, compared to other expense of $996,402 primarily due to
impairment of assets of $536,047, interest expense of $429,488 in conjunction with accretion of debt discount and original issuance discount,
and interest expense of $30,867 for the year ended December 31, 2021.
Net
loss before income taxes
Net
loss before income taxes for the year ended December 31, 2022 totaled $2,929,817 primarily due to (increases/decreases) in compensation
costs, professional fees, consulting costs, research and development costs, investor relations costs, insurance costs, and general and
administration costs compared to a loss of $3,004,619 primarily due to (increases/decreases) in compensation costs, professional fees,
consulting costs, research and development costs, investor relations costs, and general and administration cost for the year ended December
31, 2021 primarily due to professional fees.
Assets
and Liabilities
Assets
were $332,879 as of December 31, 2022. Assets consisted primarily of cash of $8,356, inventories of $50,000, other current assets of
$11,942, equipment of $22,052, intangible assets of $2,100, and operating lease right-of-use assets of $217,718, and other assets of
$20,711. Liabilities were $2,236,119 as of December 31, 2022. Liabilities consisted primarily of accounts payable of $327,517, accrued
payroll and payroll taxes of $30,124, convertible notes of $1,636,656, net of $642,660 of unamortized debt discount, operating lease
liabilities of $240,625, and other current liabilities of $1,197.
Liquidity
and Capital Resources
Going
Concern
The
accompanying financial statements have been prepared assuming the Company will continue as a going concern, which contemplates, among
other things, the realization of assets and satisfaction of liabilities in the normal course of business. The Company had an accumulated
deficit of $7,195,576 at December 31, 2022, had a working capital deficit of approximately $1,978,396 at December 31, 2022, had net losses
of $2,929,817 and $3,004,619 for the years ended December 31, 2022 and 2021, respectively, and net cash used in operating activities
of $1,830,242 and $1,774,182 for the years ended December 31, 2022 and 2021, respectively, with no revenue earned since inception, and
a lack of operational history. These matters raise substantial doubt about the Company’s ability to continue as a going concern.
While
the Company is attempting to expand operations and increase revenues, the Company’s cash position may not be significant enough
to support the Company’s daily operations. Management intends to raise additional funds by way of a public offering or an asset
sale transaction. Management believes that the actions presently being taken to further implement its business plan and generate revenues
provide the opportunity for the Company to continue as a going concern. While management believes in the viability of its strategy to
generate revenues and in its ability to raise additional funds or transact an asset sale, there can be no assurances to that effect or
on terms acceptable to the Company. The ability of the Company to continue as a going concern is dependent upon the Company’s ability
to further implement its business plan and generate revenues.
The
consolidated financial statements do not include any adjustments that might be necessary if we are unable to continue as a going concern.
General
– Overall, we had a decrease in cash flows for the year ended December 31, 2022 of $332,600 resulting from cash used in
operating activities of $1,830,242 and cash used in investing activities of $860, offset partially by cash provided by financing activities
of $1,498,502.
The
following is a summary of our cash flows provided by (used in) operating, investing, and financing activities during the periods indicated:
| |
Year Ended
December 31, 2021 | | |
Year Ended
December 31, 2020 | |
| |
| | |
| |
Net cash provided by (used in): | |
| | | |
| | |
Operating activities | |
$ | (1,830,242 | ) | |
$ | (1,774,182 | ) |
Investing activities | |
| (860 | ) | |
| (29,264 | ) |
Financing activities | |
| 1,498,502 | | |
| 2,060,000 | |
| |
$ | (332,600 | ) | |
$ | 256,554 | |
Year
Ended December 31, 2022 Compared to Year Ended December 31, 2021
Cash
Flows from Operating Activities – For the year ended December 31, 2022, net cash used in operations was $1,830,242 compared
to net cash used in operations of $1,774,182 for the year ended December 31, 2021. Net cash used in operations was primarily due to a
net loss of $2,929,817 for year ended December 31, 2022 and the changes in operating assets and liabilities of $307,007, primarily due
to the increases in other current assets of $9,867, accounts payable of $287,843, and accrued payroll and payroll taxes of $29,052, offset
primarily by decreases in other current liabilities of $21. In addition, net cash used in operating activities includes adjustments to
reconcile net profit from depreciation expense of $6,854, amortization expense of $3,600, accretion of original issuance costs of $135,812,
and the accretion of debt discount of $646,302.
Net
cash used in operations was primarily due to a net loss of $3,004,619 for year ended December 31, 2021 and the changes in operating assets
and liabilities of $34,149, primarily due to the increases in other current assets of $2,075 and other assets of $20,711, and a decrease
in accrued payroll and payroll taxes of $58,635, offset primarily by increases in accounts payable of $23,669 and other current liabilities
of $23,603. In addition, net cash used in operating activities includes adjustments to reconcile net profit from depreciation expense
of $2,946, amortization expense of $16,205, accretion of original issuance costs of $61,283, accretion of debt discount of $368,205,
stock issued for services of $249,100, interest expense converted to notes payable of $30,800, and impairment of assets of $536,047.
Cash
Flows from Investing Activities – For the year ended December 31, 2022, net cash used in investing was $860 due to the
purchase of property and equipment compared to cash flows from investing activities of $29,264 due to the purchase of property and equipment
for the year ended December 31, 2021.
Cash
Flows from Financing Activities – For the year ended December 31, 2022, net cash provided by financing was $1,498,502 due
to proceeds from short term convertible notes of $1,567,000 net of fees associated with the filing of the Company’s Form S-1 of
$68,498. For the year ended December 31, 2021, net cash provided by financing was $2,060,000 due to proceeds from short term convertible
notes of $250,000, repayments of short-term convertible notes of $55,000, and common stock and warrants issued for cash of $1,865,000.
Financing
– We expect that our current working capital position, together with our expected future cash flows from operations will
be insufficient to fund our operations in the ordinary course of business, anticipated capital expenditures, debt payment requirements
and other contractual obligations for at least the next twelve months. However, this belief is based upon many assumptions and is subject
to numerous risks, and there can be no assurance that we will not require additional funding in the future.
We
have no present agreements or commitments with respect to any material acquisitions of other businesses, products, product rights or
technologies or any other material capital expenditures. However, we will continue to evaluate acquisitions of and/or investments in
products, technologies, capital equipment or improvements or companies that complement our business and may make such acquisitions and/or
investments in the future. Accordingly, we may need to obtain additional sources of capital in the future to finance any such acquisitions
and/or investments. We may not be able to obtain such financing on commercially reasonable terms, if at all. Due to the ongoing global
economic crisis, we believe it may be difficult to obtain additional financing if needed. Even if we are able to obtain additional financing,
it may contain undue restrictions on our operations, in the case of debt financing, or cause substantial dilution for our shareholders,
in the case of equity financing.
Employment
Agreements
Mr.
Joyce receives an annual base salary of $455,000, plus bonus compensation not to exceed 50% of salary. Mr. Joyce’s employment also
provides for medical insurance, disability benefits and one year of severance pay if his employment is terminated without cause or due
to a change in control. Additionally, the Company has agreed to maintain a beneficial ownership target of 9% for Mr. Joyce. The Company
incurred compensation expense of $453,067 and $496,125 (including $18,542 of 2020 payroll paid in 2021), and employee benefits of $48,811
and $31,126, for the years ended December 31, 2022 and 2021, respectively.
Sigyn
had no employment agreement with its CTO but still incurred compensation on behalf of the CTO. The Company incurred compensation expense
of $233,678 and $259,000, and employee benefits of $25,312 and $21,704, for the years ended December 31, 2022 and 2021, respectively.
Bonus
On
July 21, 2021, as a result of achieving certain milestones, the Board of Directors agreed to pay each of the Company’s CEO and
CTO a performance bonus equal to 5% of their annual salary totaling $34,750.
Capital
Expenditures
We
expect to purchase approximately $30,000 of equipment in connection with the expansion of our business during the next twelve months.
Fiscal
Year-End
Our
fiscal year end is December 31.
Critical
Accounting Policies
Refer
to Note 3 in the accompanying notes to the consolidated financial statements for critical accounting policies.
Recent
Accounting Pronouncements
Refer
to Note 3 in the accompanying notes to the consolidated financial statements.
Future
Contractual Obligations and Commitments
Refer
to Note 3 in the accompanying notes to the consolidated financial statements for future contractual obligations and commitments. Future
contractual obligations and commitments are based on the terms of the relevant agreements and appropriate classification of items under
GAAP as currently in effect. Future events could cause actual payments to differ from these amounts.
We
incur contractual obligations and financial commitments in the normal course of our operations and financing activities. Contractual
obligations include future cash payments required under existing contracts, such as debt and lease agreements. These obligations may
result from both general financing activities and from commercial arrangements that are directly supported by related operating activities.
Details on these obligations are set forth below.
Off-Balance
Sheet Arrangements
As
of December 31, 2022, we have not entered into any transaction, agreement or other contractual arrangement with an entity unconsolidated
under which it has:
|
● |
a
retained or contingent interest in assets transferred to the unconsolidated entity or similar arrangement that serves as credit; |
|
|
|
|
● |
liquidity
or market risk support to such entity for such assets; |
|
● |
an
obligation, including a contingent obligation, under a contract that would be accounted for as a derivative instrument; or |
|
|
|
|
● |
an
obligation, including a contingent obligation, arising out of a variable interest in an unconsolidated entity that is held by, and
material to us, where such entity provides financing, liquidity, market risk or credit risk support to or engages in leasing, hedging,
or research and development services with us. |
Inflation
We
do not believe that inflation has had a material effect on our results of operations.
Item
7A. Quantitative and Qualitative Disclosure About Market Risk
We
are a smaller reporting company as defined by Rule 12b-2 of the Securities Exchange Act of 1934 and are not required to provide the information
under this item.
Item
8. Financial Statements and Supplementary Data
The
financial statements and supplementary financial information which are required to be filed under this item are presented under Item
15. Exhibits, Financial Statement Schedules and Reports on Form 10-K in this document, and are incorporated herein by reference.
Item
9. Changes in and Disagreements with Accountants on Accounting and Financial Disclosure
None.
Item
9A. Controls and Procedures
Evaluation
of Disclosure Controls and Procedures
We
maintain disclosure controls and procedures (as defined in Rule 13a-l5(e) under the Exchange Act) that are designed to ensure that information
that would be required to be disclosed in Exchange Act reports is recorded, processed, summarized and reported within the time period
specified in the SEC’s rules and forms, and that such information is accumulated and communicated to our management, including
to our Chief Executive Officer and Chief Financial Officer, as appropriate, to allow timely decisions regarding required disclosure.
Our
management, under the supervision and with the participation of our CEO and Chief Financial Officer (“CFO”), has evaluated
the effectiveness of our disclosure controls and procedures as defined in SEC Rules 13a-15(e) and 15d-15(e) as of the end of the period
covered by this report. Based on such evaluation, management identified deficiencies that were determined to be a material weakness.
Management’s
Report on Internal Controls over Financial Reporting
The
Company’s management is responsible for establishing and maintaining effective internal control over financial reporting (as defined
in Rule 13a-l5(f) of the Securities Exchange Act). Management assessed the effectiveness of the Company’s internal control over
financial reporting as of December 31, 2022. In making this assessment, management used the criteria set forth by the Committee of Sponsoring
Organizations of the Treadway Commission (“COSO”) (2013). Based on that assessment, management believes that, as of December
31, 2022, the Company’s internal control over financial reporting was ineffective based on the COSO criteria, due to the following
material weaknesses listed below.
The
specific material weaknesses identified by the company’s management as of end of the period covered by this report include the
following:
|
● |
we
have not performed a risk assessment and mapped our processes to control objectives; |
|
● |
we
have not implemented comprehensive entity-level internal controls; |
|
● |
we
have not implemented adequate system and manual controls; and |
|
● |
we
do not have sufficient segregation of duties. As such, the officers approve their own related business expense reimbursements |
Despite
the material weaknesses reported above, our management believes that our consolidated financial statements included in this report fairly
present in all material respects our financial condition, results of operations and cash flows for the periods presented and that this
report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements, in
light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report.
This
report does not include an attestation report of our registered public accounting firm regarding internal control over financial reporting.
Management’s report was not subject to attestation by our registered public accounting firm pursuant to rules of the Commission
that permit us to provide only management’s report in this report.
Management’s
Remediation Plan
The
weaknesses and their related risks are not uncommon in a company of our size because of the limitations in the size and number of staff.
Due to our size and nature, segregation of all conflicting duties has not always been possible and may not be economically feasible.
However,
we plan to take steps to enhance and improve the design
of our internal control over financial reporting. During the period covered by this annual report on Form 10-K, we have not been able
to remediate the material weaknesses identified above. To remediate such weaknesses, we plan to implement the following changes in the
current fiscal year as resources allow:
|
(i) |
appoint
additional qualified personnel to address inadequate segregation of duties and implement modifications to our financial controls
to address such inadequacies; |
|
(ii) |
hire
a new Big 4 CFO with experience working in publicly traded companies and hire a staff person to support the CFO, which was accomplished
in March 2022. |
The
remediation efforts set out herein will be implemented in the current 2023 fiscal year. Because of the inherent limitations in all control
systems, no evaluation of controls can provide absolute assurance that all control issues, if any, within our company have been detected.
These inherent limitations include the realities that judgments in decision-making can be faulty and that breakdowns can occur because
of simple error or mistake.
Management
believes that despite our material weaknesses set forth above, our consolidated financial statements for the year ended December 31,
2022 are fairly stated, in all material respects, in accordance with GAAP.
Changes
in Internal Control over Financial Reporting
There
have been no changes in our internal control over financial reporting during the fiscal year ending December 31, 2022 that have materially
affected, or are reasonably likely to materially affect, our internal control over financial reporting.
Item
9B. Other Information
There
have been no events required to be reported under this Item.
PART
III
Item
10. Directors, Executive Officers and Corporate Governance
The
following table sets forth the names, ages, and biographical information of each of our current directors and executive officers and
the positions with the Company held by each person. Our executive officers are elected annually by the board of directors. The directors
serve one-year terms until their successors are elected. The executive officers serve terms of one year or until their death, resignation
or removal by the board of directors. Unless described below, there are no family relationships among any of the directors and officers.
Name |
|
Age |
|
Title |
Jim
Joyce |
|
61 |
|
Chief
Executive Officer and Chairman of the Board of Directors (“CEO”) |
Craig
Roberts |
|
70 |
|
Chief
Technology Officer and Director |
Jeremy
Ferrell (1) |
|
52 |
|
Chief
Financial Officer |
Richa
Nand (2) |
|
49 |
|
Non-Employee
Director |
Jim
Dorst (2) |
|
68 |
|
Non-Employee
Director |
Christopher
Wetzel (2) |
|
47 |
|
Non-Employee
Director |
(1) | Mr.
Ferrell was hired as the Company’s Chief Financial Officer effective March 9, 2022. |
(2) | Ms.
Nand, Mr. Dorst and Mr. Wetzel were appointed as Non-Executive Directors effective October
10, 2022. |
Executive
Officers
Jim
Joyce. Mr. Joyce is a Co-founder of Sigyn Therapeutics and has served as Chairman and CEO of the Company since it was founded
in 2019. He has 30+ years of diverse public market experience, which includes two decades of public company CEO and Corporate Board leadership
roles. Previously, Mr. Joyce was the founder of Exosome Sciences, Inc., where he served as Executive Chairman from 2011 to 2018. Mr.
Joyce is also the founder, former Chairman and CEO of Aethlon Medical, a therapeutic device company that he navigated from a single shareholder
start-up to Nasdaq-traded Company with 8000+ shareholders.
While
employed at Aethlon from 1999 to 2018, Mr. Joyce oversaw the development of the Aethlon Hemopurifier, the first therapeutic candidate
to receive two “Breakthrough Device” designations from the FDA. Under his leadership, the Hemopurifier received FDA “Emergency
Use Authorization” (EAU) approval to treat Ebola virus and additionally was cleared to treat Ebola by the German Government and
Health Canada. Time Magazine named the Hemopurifier one of the “11 Most Remarkable Advances in Healthcare” and designated
the device to its “Top 25 Best Inventions” award list.
During
Mr. Joyce’s tenure, Aethlon won multiple Department of Defense (DOD) contract awards, a National Cancer Institute (NCI) contract
award and grants from the National Institutes of Health (NIH). He also led the completion of approximately $100 million of equity financings
and originated preclinical and clinical collaborations with more than twenty government and non-government institutes and organizations.
We
believe Mr. Joyce’s service as our Chief Executive Officer, his extensive experience in therapeutic device technologies, his prior
board service and his extensive public company background qualifies him to serve on our board of directors.
Craig
Roberts. Mr. Roberts is an inventor of therapeutic device technologies, which includes a Percutaneous Adult Extracorporeal Membrane
Oxygenation (ECMO) system that was licensed and subsequently sold to C.R. Bard. During the ongoing pandemic, ECMO has been broadly deployed
to treat critically ill COVID-19 patients. Additionally, Mr. Roberts is the inventor of the IMPACT System, which received CE Mark clearance
in the European Union and was subsequently registered in 32 countries and successfully deployed to treat cytokine storm related conditions,
including sepsis, acute respiratory distress syndrome (ARDS), acute liver failure, severe pneumonia and H5N1 bird flu virus infection.
Mr.
Roberts is a Co-founder of Sigyn Therapeutics and has been our Chief Technical Officer since it was founded in 2019. Prior to joining
the Company, Mr. Roberts served as a consultant for Aethlon Medical, Inc. from 2016 to 2019. Prior to Aethlon, Mr. Roberts was a founder,
Chief Technology Officer and Board Member of Hemolife Medical, Inc. We believe Mr. Roberts’s service as our Chief Technology Officer,
his extensive experience with therapeutic device technologies and his previous service as board of medical device company qualifies him
to serve on our board of directors.
Jeremy
Ferrell. Mr. Ferrell has more than 25 years of finance and operations leadership experience, with expertise in venture capital;
mergers and acquisitions; due diligence; initial public offerings; strategic alliance negotiation; and financial planning and reporting.
Mr. Ferrell has served as our CFO since March 2022. Prior to joining the Company, Mr. Ferrell served as the CFO at Miku, Inc, from 2018
to 2022. Previously, he founded a Fractional CFO Services firm, where he served as CFO for various life sciences and technology companies,
including Singular Genomics, Inc., Aspen Neuroscience, Inc., and Hyduro, Inc. Before that, he served as Corporate Controller for ecoATM,
Inc., which was acquired by Outerwall, Inc. in 2013. Earlier in his career, Mr. Ferrell practiced as a certified public accountant. Mr.
Ferrell received his Bachelor of Science degree in Accountancy from Liberty University and his Master of Business Administration degree
in International Finance from the Thunderbird School of Global Management.
Non-Employee
Directors
Richa
Nand. Ms.Nand is a senior legal executive with more than 20 years of experience as an intellectual property (“IP”)
attorney and strategic business advisor for biotechnology and medical device companies. Ms. Nand is the founder of Insight Patents, a
legal and consulting firm providing IP and transactional corporate services for the life sciences industry. Ms. Nand previously served
as Vice President of Corporate Development and Legal at Bird Rock Bio – a Johnson & Johnson-backed biopharmaceutical company
in San Diego – and Vice President of Intellectual Property and Licensing; Director of Business Development; and In-House Patent
Counsel at Cytori Therapeutics. Prior to law school, she was a biomedical researcher at Cedars Sinai Medical Center in Beverly Hills,
California. Ms. Nand received a Bachelor of Science degree in Microbiology and Molecular Genetics from the University of California,
Los Angeles, and a Juris Doctor degree from Boston University School of Law. We believe Ms. Nad’s experience in the healthcare
field makes her well suited to serve on our Board.
Jim
Dorst. Mr. Dorst has more than 30 years of senior management experience in finance, operations, planning and business transactions
at both private and public companies. He was most recently Director of Corporate Development at SYNNEX/Concentrix, where he was primarily
responsible for mergers and acquisitions. Mr. Dorst was previously Chief Operating Officer (“COO”) and Chief Financial Officer
(“CFO”) at SpectraScience, Inc.; CFO of Aethlon Medical, Inc. and Vice President of Finance and Operations for Verdisoft
Corporation. In addition, he previously served as Senior Vice President of Finance and Administration at SeeCommerce; CFO and COO of
Omnis Technology Corp; and CFO and Senior Vice President of Information Technology at Savoir Technology Group, Inc. Mr. Dorst practiced
as a Certified Public Accountant with Coopers & Lybrand (now PricewaterhouseCoopers LLP); and holds a Master of Science degree in
Accounting and a Bachelor of Science degree in Finance from the University of Oregon. We believe Mr. Dorst’s public company experience
makes him well suited to sit on our Board.
Christopher
Wetzel. Mr. Wetzel has more than 25 years of leadership experience in various aspects of the healthcare delivery system and since
2004, has served as Chief Executive Officer for the Surgery Center at Hamilton in New Jersey. His career has focused on building organizations,
increasing operational efficiency, increasing profitability, maximizing revenue, and managing change in the complex and high-growth healthcare
environment. Mr. Wetzel applied his broad background in strategy, finance, and operations to guide various entities starting new ventures,
entering new markets, and reengineering business processes. He is a long-term investor in the extracorporeal therapy space. Mr. Wetzel
received a Master of Business Administration degree in Healthcare Management and a Bachelor of Science degree in Nursing from Thomas
Jefferson University (formerly Philadelphia University). Mr. Wetzel’s experience in the health care field well serves him to sit
on our Board.
Conflicts
of Interest
Certain
potential conflicts of interest are inherent in the relationships between our officers and directors and us.
From
time to time, one or more of our affiliates may form or hold an ownership interest in and/or manage other businesses both related and
unrelated to the type of business that we own and operate. These persons expect to continue to form, hold an ownership interest in and/or
manage additional other businesses which may compete with our business with respect to operations, including financing and marketing,
management time and services and potential customers. These activities may give rise to conflicts between or among the interests of us
and other businesses with which our affiliates are associated. Our affiliates are in no way prohibited from undertaking such activities,
and neither we nor our shareholders will have any right to require participation in such other activities.
We
may transact business with some of our officers, directors and affiliates, as well as with firms in which some of our officers, directors
or affiliates have a material interest, potential conflicts may arise between the respective interests of us and these related persons
or entities. We believe that such transactions will be effected on terms at least as favorable to us as those available from unrelated
third parties. As of this filing, we have not transacted business with any officer, director, or affiliate.
With
respect to transactions involving real or apparent conflicts of interest, we have adopted policies and procedures which require that:
(i) the fact of the relationship or interest giving rise to the potential conflict be disclosed or known to the directors who authorize
or approve the transaction prior to such authorization or approval, (ii) the transaction be approved by a majority of our disinterested
outside directors, and (iii) the transaction be fair and reasonable to us at the time it is authorized or approved by our directors.
Our
policies and procedures regarding transactions involving potential conflicts of interest are not in writing. We understand that it will
be difficult to enforce our policies and procedures and will rely and trust our officers and directors to follow our policies and procedures.
We will implement our policies and procedures by requiring the officer or director who is not in compliance with our policies and procedures
to remove himself and the other officers and directors will decide how to implement the policies and procedures, accordingly.
Corporate
Governance
The
Company promotes accountability for adherence to honest and ethical conduct; endeavors to provide full, fair, accurate, timely and understandable
disclosure in reports and documents that the Company files with the Securities and Exchange Commission (the “SEC”) and in
other public communications made by the Company; and strives to be compliant with applicable governmental laws, rules and regulations.
Director
Independence
Our
board of directors consists of five members, with three independent directors (all of our Non Employee Directors are independent) in
accordance with NASDAQ listing rule 5605(a)(2) before we uplist via an amendment to this registration statement of which this prospectus
is a part. Because our common stock is not currently listed on a national securities exchange, we have used the definition of “independence”
of The NASDAQ Stock Market to make this determination. NASDAQ Listing Rule 5605(a)(2) provides that an “independent director”
is a person other than an 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. The NASDAQ listing rules provide that a director cannot be considered independent if:
| ● | the
director is, or at any time during the past three years was, an employee of the company; |
| ● | the
director or a family member of the director accepted any compensation from the company in
excess of $120,000 during any period of 12 consecutive months within the three years preceding
the independence determination (subject to certain exclusions, including, among other things,
compensation for board or board committee service); |
| ● | a
family member of the director is, or at any time during the past three years was, an executive
officer of the company; |
| ● | the
director or a family member of the director is a partner in, controlling stockholder of,
or an executive officer of an entity to which the company made, or from which the company
received, payments in the current or any of the past three fiscal years that exceed 5% of
the recipient’s consolidated gross revenue for that year or $200,000, whichever is
greater (subject to certain exclusions); |
| ● | the
director or a family member of the director is employed as an executive officer of an entity
where, at any time during the past three years, any of the executive officers of the company
served on the compensation committee of such other entity; or |
| ● | the
director or a family member of the director is a current partner of the Company’s outside
auditor, or at any time during the past three years was a partner or employee of the Company’s
outside auditor, and who worked on the company’s audit. |
Board
Composition
Our
business and affairs are managed under the direction of our board of directors, which consists of five members. Directors serve for a
term of one year and until their successors have been duly elected and qualified.
Committees
of the Board
Our
Company currently does not have nominating, compensation, or audit committees or committees performing similar functions nor does our
Company have a written nominating, compensation or audit committee charter. The Company plans to update its board committees to meet
NASDAQ requirements via an amendment to this registration statement of which this prospectus is a part.
In
lieu of an audit committee, the Company’s board of directors is responsible for reviewing and making recommendations concerning
the selection of outside auditors, reviewing the scope, results and effectiveness of the annual audit of the Company’s consolidated
financial statements and other services provided by the Company’s independent public accountants. The board of directors, the Chief
Executive Officer and the Chief Financial Officer of the Company review the Company’s internal accounting controls, practices and
policies.
The
Company maintains a Scientific Advisory Board (“SAB”) to assist our Board of Directors by reviewing and evaluating our clinical
development programs. We intend for our SAB members to receive per meeting fees and also be eligible to receive stock option compensation.
However, a formal SAB compensation plan has not yet been approved by our Board of Directors.
Audit
Committee Financial Expert
Mr.
Dorst qualifies as an “audit committee financial expert” as defined in Item 407(D)(5) of Regulation S-K, and our three new
directors qualify as “independent” as the term is used in Item 7(d)(3)(iv)(B) of Schedule 14A under the Securities Exchange
Act of 1934, as amended, and as defined by Rule 4200(a)(14) of the FINRA Rules.
We
believe that our directors are capable of analyzing and evaluating our consolidated financial statements and understanding internal controls
and procedures for financial reporting. The directors of our Company do not believe that it is necessary to have an audit committee because
management believes that the board of directors can adequately perform the functions of an audit committee. In addition, we believe that
retaining an independent director who would qualify as an “audit committee financial expert” would be overly costly and burdensome
and is not warranted in our circumstances given the stage of our development and the fact that we have not generated any positive cash
flows from operations to date.
Involvement
in Certain Legal Proceedings
Our
directors and our executive officers have not been involved in or a party in any of the following events or actions during the past ten
years:
| 1. | any
bankruptcy petition filed by or against any business of which such person was a general partner
or executive officer either at the time of the bankruptcy or within two years prior to that
time; |
| | |
| 2. | any
conviction in a criminal proceeding or being subject to a pending criminal proceeding (excluding
traffic violations and other minor offenses); |
| | |
| 3. | being
subject to any order, judgment, or decree, not subsequently reversed, suspended or vacated,
of any court of competent jurisdiction, permanently or temporarily enjoining, barring, suspending
or otherwise limiting his involvement in any type of business, securities or banking activities;
or |
| | |
| 4. | being
found by a court of competent jurisdiction (in a civil action), the Commission or the Commodity
Futures Trading Commission to have violated a federal or state securities or commodities
law, and the judgment has not been reversed, suspended, or vacated. |
| 5. | Such
person was found by a court of competent jurisdiction in a civil action or by the Commission
to have violated any Federal or State securities law, and the judgment in such civil action
or finding by the Commission has not been subsequently reversed, suspended, or vacated; |
| | |
| 6. | Such
person was found by a court of competent jurisdiction in a civil action or by the Commodity
Futures Trading Commission to have violated any Federal commodities law, and the judgment
in such civil action or finding by the Commodity Futures Trading Commission has not been
subsequently reversed, suspended or vacated; |
| | |
| 7. | Such
person was the subject of, or a party to, any Federal or State judicial or administrative
order, judgment, decree, or finding, not subsequently reversed, suspended or vacated, relating
to an alleged violation of: (I) Any Federal or State securities or commodities law or regulation;
or (ii) Any law or regulation respecting financial institutions or insurance companies including,
but not limited to, a temporary or permanent injunction, order of disgorgement or restitution,
civil money penalty or temporary or permanent cease-and-desist order, or removal or prohibition
order; or (iii) Any law or regulation prohibiting mail or wire fraud or fraud in connection
with any business entity; or |
| | |
| 8. | Such
person was the subject of, or a party to, any sanction or order, not subsequently reversed,
suspended or vacated, of any self-regulatory organization (as defined in Section 3(a)(26)
of the Exchange Act (15 U.S.C. 78c(a)(26))), any registered entity (as defined in Section
1(a)(29) of the Commodity Exchange Act (7 U.S.C. 1(a)(29))), or any equivalent exchange,
association, entity or organization that has disciplinary authority over its members or persons
associated with a member. |
Code
of Ethics
The
Company has not formally adopted a written Code of Ethics that governs the Company’s employees, officers and directors as the Company
is not required to do so. The board of directors evaluated the business of the Company and the number of employees and determined that
since the business is operated by a small number of persons, general rules of fiduciary duty and federal and state criminal, business
conduct and securities laws are adequate ethical guidelines. In the event our operations, employees and/or directors expand in the future,
we may take actions to adopt a formal Code of Ethics.
Role
of Board of Directors in Risk Oversight
Our
board of directors oversees an enterprise-wide approach to risk management, designed to support the achievement of business objectives,
including organizational and strategic objectives, to improve long-term organizational performance and enhance stockholder value. The
involvement of our board of directors in setting our business strategy is a key part of its assessment of management’s plans for
risk management and its determination of what constitutes an appropriate level of risk for our company. The participation of our board
of directors in our risk oversight process includes receiving regular reports from members of senior management on areas of material
risk to our company, including operational, financial, legal and regulatory, and strategic and reputational risks.
While
our board of directors has the ultimate responsibility for the risk management process, senior management and various committees of our
board of directors, when formed, will also have responsibility for certain areas of risk management. Our senior management team is responsible
for day-to-day risk management and regularly reports on risks to our full board of directors or a relevant committee. Our finance and
regulatory personnel serve as the primary monitoring and evaluation function for company-wide policies and procedures, and manage the
day-to-day oversight of the risk management strategy for our ongoing business. This oversight includes identifying, evaluating, and addressing
potential risks that may exist at the enterprise, strategic, financial, operational, compliance and reporting levels.
Director
Compensation
Our
Non-Employee directors receive a $30,000 annual retainer, paid in equal quarterly amounts for which periods the directors have provided
service. In addition, each director receives a grant of restricted stock units with a grant date fair value of $50,000 or, at the discretion
of the Board, options to acquire shares of common stock. Employee directors, have not been separately compensated for their services
to the Company as a director.
Limitation
on Liability and Indemnification Matters
Our
Certificate of Incorporation and Bylaws provide that we will indemnify our directors and officers, and may indemnify our employees and
other agents, to the fullest extent permitted by the Delaware General Corporation Law, which prohibits our Certificate of Incorporation
from limiting the liability of our directors for the following:
| ● | any
breach of the director’s duty of loyalty to the corporation or its shareholders; |
| | |
| ● | any
act or omission not in good faith or that involves intentional misconduct or a knowing violation
of law; |
| | |
| ● | unlawful
payments of dividends or unlawful stock repurchases or redemptions; or |
| | |
| ● | any
transaction from which the director derived an improper personal benefit. |
If
Delaware law is amended to authorize corporate action further eliminating or limiting the personal liability of a director, then the
liability of our directors will be eliminated or limited to the fullest extent permitted by Delaware law, as so amended. Our Certificate
of Incorporation does not eliminate a director’s duty of care and in appropriate circumstances, equitable remedies, such as injunctive
or other forms of non-monetary relief, remain available under Delaware law. This provision also does not affect a director’s responsibilities
under any other laws, such as the federal securities laws or other state or federal laws. Under our bylaws, we will also be empowered
to purchase insurance on behalf of any person whom we are required or permitted to indemnify.
The
limitation of liability and indemnification provisions in our Certificate of Incorporation and bylaws may discourage shareholders from
bringing a lawsuit against directors for breach of their fiduciary duties. They may also reduce the likelihood of derivative litigation
against directors and officers, even though an action, if successful, might benefit us and our shareholders. A shareholder’s investment
may be harmed to the extent we pay the costs of settlement and damage awards against directors and officers pursuant to these indemnification
provisions. Insofar as we may provide indemnification for liabilities arising under the Securities Act to our directors, officers, and
controlling persons pursuant to the foregoing provisions, or otherwise, we have been advised that, in the opinion of the SEC, such indemnification
is against public policy as expressed in the Securities Act, and is, therefore, unenforceable. There is no pending litigation or proceeding
naming any of our directors or officers as to which indemnification is being sought, nor are we aware of any pending or threatened litigation
that may result in claims for indemnification by any director or officer.
Item
11. Executive Compensation
The
following is a discussion and analysis of compensation arrangements of our named executive officers, or NEOs. This discussion contains
forward looking statements that are based on our current plans, considerations, expectations and determinations regarding future compensation
programs. Actual compensation programs that we adopt may differ materially from currently planned programs as summarized in this discussion.
As an “emerging growth company” as defined in the JOBS Act, we are not required to include a Compensation Discussion and
Analysis section and have elected to comply with the scaled disclosure requirements applicable to emerging growth companies.
Summary
Compensation Table
The
particulars of the compensation paid to the following persons: (1) our principal executive officer; and (2) each of our two most highly
compensated executive officers who were serving as executive officers at the end of the fiscal year ended December 31, 2022, who we will
collectively refer to as the “named executive officers” of the Company, are set out in the following summary compensation
table:
SUMMARY
COMPENSATION TABLE
| |
| | |
| | |
| | |
| | |
| | |
| | |
Change in | | |
| | |
| |
| |
| | |
| | |
| | |
| | |
| | |
| | |
Pension | | |
| | |
| |
| |
| | |
| | |
| | |
| | |
| | |
| | |
Value and | | |
| | |
| |
| |
| | |
| | |
| | |
| | |
| | |
Non-Equity | | |
Nonqualified | | |
| | |
| |
| |
| | |
| | |
| | |
Stock | | |
Option | | |
Incentive Plan | | |
Deferred | | |
All Other | | |
| |
Name and | |
| | |
Salary | | |
Bonus | | |
Awards | | |
Awards | | |
Compensation | | |
Compensation | | |
Compensation | | |
Total | |
Principal Position | |
Year | | |
($) | | |
($) | | |
($) | | |
($) | | |
($) | | |
Earnings ($) | | |
($)
(1) | | |
($) | |
Jim Joyce | |
| 2022 | | |
| 453,067 | | |
| - | | |
| - | | |
| - | | |
| - | | |
| - | | |
$ | 48,811 | | |
$ | 501,878 | |
Chief Executive Officer | |
| 2021 | | |
| 473,375 | | |
| 22,750 | | |
| - | | |
| - | | |
| - | | |
| - | | |
$ | 31,126 | | |
$ | 527,251 | |
| |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | |
Craig Roberts | |
| 2022 | | |
| 233,678 | | |
| - | | |
| - | | |
| - | | |
| - | | |
| - | | |
$ | 25,312 | | |
$ | 258,990 | |
Chief Technology Officer | |
| 2021 | | |
| 247,000 | | |
| 12,000 | | |
| - | | |
| - | | |
| - | | |
| - | | |
$ | 21,704 | | |
$ | 280,704 | |
| |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | |
Jeremy Ferrell | |
| 2022 | | |
| 177,083 | | |
| - | | |
| - | | |
| - | | |
| - | | |
| - | | |
$ | 23,205 | | |
$ | 200,288 | |
Chief Financial Officer (2) | |
| 2021 | | |
| - | | |
| - | | |
| - | | |
| - | | |
| - | | |
| - | | |
$ | - | | |
$ | - | |
| (1) | Amounts
include health insurance and employer matched 401(k) costs. |
| | |
| (2) | Mr.
Ferrell was hired as the Company’s Chief Financial Officer effective March 9, 2022.
Mr. Ferrell receives an annual base salary of $250,000, amended to $62,500 on December 1,
2022. |
Other
than as disclosed below, there are no compensatory plans or arrangements with respect to our executive officers resulting from their
resignation, retirement or other termination of employment or from a change of control.
Grants
of Plan-Based Awards Table
None
of our named executive officers received any grants of stock, option awards or other plan-based awards during the years ended December
31, 2022 and 2021, except as described below in “Equity Compensation Plans and Other Benefit Plans” below.
Options
Exercised and Stock Vested Table
None
of our named executive officers exercised any stock options or restricted stock units during the years ended December 31, 2022 and 2021.
Outstanding
Equity Awards at 2022 Year End
Except
as described below in “Equity Compensation Plans and Other Benefit Plans”, the Company has not issued any awards to its named
executive officers. The Company and its board of directors may grant awards as it sees fit to its employees as well as key consultants.
See the discussion of “Equity Compensation Plans and Other Benefit Plans” below.
Agreements
with Executive Officers
Jim
Joyce
Mr.
Joyce receives an annual base salary of $455,000, plus bonus compensation not to exceed 50% of salary. Mr. Joyce’s employment also
provides for medical insurance, disability benefits and one year of severance pay if his employment is terminated without cause or due
to a change in control. Additionally, the Company has agreed to maintain a beneficial ownership target of 9% for Mr. Joyce. There is
no written employment agreement for Mr. Joyce at this time.
Jeremy
Ferrell
Mr.
Ferrell was hired March 9, 2022 as the Company’s Chief Financial Officer. Mr. Ferrell receives an annual base salary of $250,000,
amended to $62,500 on December 1, 2022, plus discretionary bonus compensation not to exceed 40% of salary. Mr. Ferrell’s employment
also provides for medical insurance, disability benefits and three months of severance pay if his employment is terminated without cause
or due to a change in control. Additionally, Mr. Ferrell will be granted up to 600,000 options to purchase 600,000 of the Company’s
common shares upon the implementation of a Company employee option plan.
Craig
Roberts
Mr.
Roberts, the Company’s Chief Technology Officer (CTO) receives an annual base salary of $240,000 as well as medical insurance and
related benefits. Mr. Roberts is eligible to receive bonus compensation at the discretion of the Sigyn Therapeutics, Inc. Board of Directors.
Equity
Compensation Plans and Other Benefit Plans
The
Company does not currently have any equity compensation plans and there are no arrangements or plans in which we provide pension, retirement
or similar benefits for directors or executive officers. We have no material bonus or profit-sharing plans.
Indebtedness
of Directors, Senior Officers, Executive Officers and Other Management
None
of our directors or executive officers or any associate or affiliate of the Company during the last two fiscal years, is or has been
indebted to the Company by way of guarantee, support agreement, letter of credit or other similar agreement or understanding currently
outstanding.
Outstanding
Equity Awards at Fiscal Year-End Table
The
following table sets forth certain information concerning outstanding stock awards held by the Named Executive Officers for our year
ended December 31, 2022:
| |
Option Awards | | |
Stock Awards | |
Name | |
Number of Securities Underlying Unexercised Options (#) Exercisable | | |
Number of Securities Underlying Unexercised Options (#) Unexercisable | | |
Equity Incentive Plan Awards: Number of Securities Underlying Unexercised Unearned Options (#) | | |
Option Exercise Price ($) | | |
Option Expiration Date | | |
Number of Shares or Units of Stock That Have Not Vested (#) | | |
Market Value of Shares or Units of Stock That Have Not Vested ($) | | |
Equity Incentive Plan Awards: Number of Unearned Shares, Units or Other Rights That Have Not Vested (#) | | |
Equity Incentive Plan Awards: Market or Payout Value of Unearned Shares, Units or Other Rights That Have Not Vested ($) | |
| |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | |
None. | |
| -0- | | |
| -0- | | |
| -0- | | |
| -0- | | |
| -0- | | |
| -0- | | |
| -0- | | |
| -0- | | |
| -0- | |
Item
12. Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters
The
following table sets forth information relating to the beneficial ownership our common stock as of March 31, 2023 by (i) each person
known to be the beneficial owner of more than 5% of the outstanding shares of common stock and (ii) each of our directors and executive
officers. Unless otherwise noted below, we believe that all persons named in the table have sole voting and investment power with respect
to all shares of common stock beneficially owned by them. For purposes hereof, a person is deemed to be the beneficial owner of securities
that can be acquired by such person within 60 days from the date hereof upon the exercise of warrants or options or the conversion of
convertible securities. Each beneficial owner’s percentage ownership is determined by assuming that any warrants, options or convertible
securities that are held by such person (but not those held by any other person) and which are exercisable within 60 days from the date
hereof, have been exercised.
Name and Address (2) | |
Amount of Beneficial Ownership | | |
Percent of Class (1) | |
| |
| | |
| |
Jim Joyce (3) | |
| 12,820,000 | | |
| 30.0 | % |
Craig Roberts (4) | |
| 12,820,000 | | |
| 30.0 | % |
Jeremy Ferrell (5) | |
| - | | |
| - | % |
Chris Wetzel (8) | |
| 127,666 | | |
| 0.3 | % |
| |
| | | |
| | |
All Officers and Directors as a Group (2 Persons) | |
| 25,640,000 | ) | |
| 60.0 | % |
| |
| | | |
| | |
Brio Capital Master Fund Ltd. (6) | |
| 3,725,850 | | |
| 8.7 | % |
| |
| | | |
| | |
Osher Capital Partners LLC (7) | |
| 3,050,658 | | |
| 7.1 | % |
(1)
|
Based
on 42,713,325 shares of common stock issued and outstanding. |
|
|
(2)
|
Unless
otherwise noted, the address of each beneficial owner is c/o Sigyn Therapeutics, Inc., 2468 Historic Decatur Road, Suite 140, San
Diego, CA 92106. |
|
|
(3)
|
Mr.
Joyce is the Company’s CEO. |
|
|
(4)
|
Mr.
Roberts is the Company’s CTO. |
|
|
(5)
|
Mr.
Ferrell is the Company’s CFO. |
|
|
(6)
|
Consists
of 3,725,850 common shares as of the date of this filing. Brio Capital Master Fund Ltd (“Brio”) is contractually limited
to beneficial ownership of our common stock not to exceed 9.99%. The stockholder of record by the stockholder is held by Shaye Hirsch
who is a director of Brio. The business address of Brio is 100 Merrick Road, Suite 401W, Rockville Center, NY 11570. |
|
|
(7)
|
Consists
of 3,050,658 common shares as of the date of this filing. Osher Capital Partners LLC (“Osher”) is contractually limited
to beneficial ownership of our common stock not to exceed 9.99%. The Stockholder has advised us that voting and dispositive power
of all the common shares of the Company owned of record by the stockholder is held by Ari Kluger, who is President of Osher. The
business address of Osher is 23 Tammy Lane, Spring Valley NY 10977. |
|
|
(8) |
Mr. Wetzel is a director of the Company. |
We
are not aware of any person who owns of record, or is known to own beneficially, five percent or more of our outstanding securities of
any class, other than as set forth above. We do not have an investment advisor. There are no current arrangements which will result in
a change in control.
Equity
Compensation Plans
The
following represents a summary of the Equity Compensation grants and options awards outstanding at December 31, 2022 and 2021 and changes
during the years then ended:
2022 and 2021 |
Plan category | |
Number of securities to be issued upon exercise of outstanding options, warrants and rights | | |
Weighted-average exercise price of outstanding options, warrants and rights | | |
Number of securities remaining available for future issuance under equity compensation plan (excluding securities reflected in column (a)) | |
| |
(a) | | |
(b) | | |
(c) | |
Equity compensation plans approved by security holders | |
| -0- | | |
$ | -0- | | |
| -0- | |
Equity compensation plans not approved by security holders | |
| -0- | | |
$ | -0- | | |
| -0- | |
Total | |
| -0- | | |
$ | -0- | | |
| -0- | |
Item
13. Certain Relationships and Related Transactions, and Director Independence
Other
than compensation arrangements, we describe below transactions and series of similar transactions, since January 1, 2020 (i.e., the last
two completed fiscal years), to which we were a party or will be a party, in which the amounts involved exceeded or will exceed the lesser
of $120,000 or 1% of the average of our total assets at year-end for the last two completed fiscal years; and any of our directors,
executive officers, or holders of more than 5% of our capital stock, or any member of the immediate family of the foregoing persons,
had or will have a direct or indirect material interest. Compensation arrangements, including employment agreements, for our directors
and named executive officers are described elsewhere in “Executive Compensation - Agreements with Executive Officers.” Neither
of our directors is independent.
Employment
Agreement
Mr.
Joyce receives an annual base salary of $455,000, plus bonus compensation not to exceed 50% of salary. Mr. Joyce’s employment also
provides for medical insurance, disability benefits and one year of severance pay if his employment is terminated without cause or due
to a change in control. Additionally, the Company has agreed to maintain a beneficial ownership target of 9% for Mr. Joyce. The Company
incurred compensation expense of $453,067 and $496,125 (including $18,542 of 2020 payroll paid in 2021), and employee benefits of $48,811
and $31,126, for the years ended December 31, 2022 and 2021, respectively.
Sigyn
had no employment agreement with its CTO but Sigyn still incurred compensation on behalf of the CTO. The Company incurred compensation
expense of $233,678 and $259,000, and employee benefits of $25,312 and $21,704, for the years ended December 31, 2022 and 2021, respectively.
Mr.
Ferrell was hired March 9, 2022 as the Company’s Chief Financial Officer. Mr. Ferrell receives an annual base salary of $250,000,
amended to $62,500 on December 1, 2022, plus discretionary bonus compensation not to exceed 40% of salary. Mr. Ferrell’s employment
also provides for medical insurance, disability benefits and three months of severance pay if his employment is terminated without cause
or due to a change in control. Additionally, Mr. Ferrell will be granted up to 600,000 options to purchase 600,000 of the Company’s
common shares upon the implementation of a Company employee option plan.
Indemnification
Agreements
We
have entered or intend to enter into indemnification agreements with each of our directors and executive officers. These agreements,
among other things, will require us to indemnify each individual to the fullest extent permitted by Delaware law, including indemnification
of expenses such as attorneys’ fees, judgments, fines and settlement amounts incurred by the individual in any action or proceeding,
including any action or proceeding by or in right of us, arising out of the person’s services as a director, officer or other employee.
Policies
and Procedures for Related Party Transactions
Given
our small size and limited financial resources, we have not adopted formal policies and procedures for the review, approval or ratification
of transactions with our executive officer(s), director(s) and significant shareholders. We rely on our board to review related party
transactions on an ongoing basis to prevent conflicts of interest. Our board reviews a transaction in light of the affiliations of the
director, officer or employee and the affiliations of such person’s immediate family. Transactions are presented to our board for
approval before they are entered into or, if this is not possible, for ratification after the transaction has occurred. If our board
finds that a conflict of interest exists, then it will determine the appropriate remedial action, if any. Our board approves or ratifies
a transaction if it determines that the transaction is consistent with the best interests of the Company. We intend to establish formal
policies and procedures in the future, once we have sufficient resources and have appointed additional directors, so that such transactions
will be subject to the review, approval or ratification of our board of directors, or an appropriate committee thereof.
Item
14. Principal Accounting Fees and Services
The
aggregate fees billed for the most recently completed fiscal period for the audit of our annual financial statements and services normally
provided by the independent registered public accounting firm for this fiscal period were as follows:
| |
FY 2022 | | |
FY 2021 | |
Audit Fees | |
$ | 36,850 | | |
$ | 35,000 | |
Total Fees | |
$ | 36,850 | | |
$ | 35,000 | |
In
the above table, “audit fees” are fees billed by our external auditor for services provided in auditing our annual financial
statements for the subject year. The fees set forth on the foregoing table relate to the audit as of and for the years ended December
31, 2022 and 2021 which were performed by Paris, Kreit & Chiu CPA LLP (formerly Benjamin & Ko). All of the services described
above were approved in advance by the Board of Directors or the Company’s Audit Committee.
NOTES
TO THE CONSOLIDATED FINANCIAL STATEMENTS
FOR
THE YEARS ENDED DECEMBER 31, 2022 AND 2021
NOTE
1 – ORGANIZATION AND PRINCIPAL ACTIVITIES
Corporate
History and Background
Sigyn
Therapeutics, Inc. (“Sigyn”, the “Company”, “we,” “us,” or “our”) is a development-stage
company focused on creating therapeutic solutions that address unmet needs in global health.
Sigyn
Therapy™, our lead product candidate, is a broad-spectrum blood purification technology designed to treat pathogen-associated inflammatory
disorders that are not addressed with approved drug therapies. Candidate treatment indications include endotoxemia and inflammation in
end-stage renal disease (dialysis) patients, sepsis (a leading cause of hospital deaths), community acquired pneumonia (a leading cause
of death among infectious diseases), and emerging pandemic threats.
Our
development pipeline includes a cancer treatment system comprised of ChemoPrep™ to enhance the tumor site delivery of chemotherapy,
and ChemoPure™ to reduce treatment toxicity and inhibit the spread of cancer metastasis.
Merger
Transaction
On
October 19, 2020, Sigyn Therapeutics, Inc, a Delaware corporation (the “Registrant”) formerly known as Reign Resources Corporation,
completed a Share Exchange Agreement (the “Agreement”) with Sigyn Therapeutics, Inc., a private entity incorporated in the
State of Delaware on October 19, 2019.
In
the Share Exchange Agreement, we acquired 100% of the issued and outstanding shares of privately held Sigyn Therapeutics common stock
in exchange for 75% of the fully paid and nonassessable shares of our common stock outstanding (the “Acquisition”). In conjunction
with the transaction, we changed our name from Reign Resources Corporation to Sigyn Therapeutics, Inc. pursuant to an amendment to our
articles of incorporation that was filed with the State of Delaware. Subsequently, our trading symbol was changed to SIGY. The Acquisition
was treated by the Company as a reverse merger in accordance with accounting principles generally accepted in the United States of America
(“GAAP”). For accounting purposes, Sigyn is considered to have acquired Reign Resources Corporation as the accounting acquirer
because: (i) Sigyn stockholders own 75% of the combined company, on an as-converted basis, immediately following the Closing Date, (ii)
Sigyn directors hold a majority of board seats in the combined company and (iii) Sigyn management held all key positions in the management
of the combined company. Accordingly, Sigyn’s historical results of operations will replace Reign Resources Corporation’s
historical results of operations for all periods prior to the Acquisition and, for all periods following the Acquisition, the results
of operations of the combined company will be included in the Company’s financial statements. The
Acquisition was treated as a “tax-free exchange” under Section 368 of the Internal Revenue Code of 1986 and resulted in the
private Sigyn Therapeutics corporate entity (established on October 29, 2019) to become a wholly owned subsidiary of Reign Resources
Corporation. Among the conditions for closing the acquisition, the Reign Resources Corporation extinguished all previously reported liabilities,
its preferred class of shares, and all stock purchase options. As a result, the reported liabilities totaling $3,429,516 were converted
into a total of 7,907,351 common shares. Additionally, assets held on the books of Reign Resources
Corporation, such as Gem inventory, was kept in the Company and therefore recorded as assets on the Share Exchange date. Upon
the closing of the Acquisition, we appointed James A. Joyce and Craig P. Roberts to serve as members of our Board of Directors.
As
of March 31, 2023, we have a total 42,713,325 shares issued and outstanding, of which 17,073,325 shares are held by non-affiliate stockholders.
NOTE
2 – BASIS OF PRESENTATION
The
accompanying financial statements have been prepared in accordance with accounting principles generally accepted in the United States
of America and include all adjustments necessary for the fair presentation of the Company’s financial position and results of operations
for the periods presented.
The
Company currently operates in one business segment. The Company is not organized by market and is managed and operated as one business.
A single management team reports to the chief operating decision maker, the Chief Executive Officer, who comprehensively manages the
entire business. The Company does not currently operate any separate lines of businesses or separate business entities.
Going
Concern
The
accompanying financial statements have been prepared assuming the Company will continue as a going concern, which contemplates, among
other things, the realization of assets and satisfaction of liabilities in the normal course of business. The Company had an accumulated
deficit of $7,195,576 at December 31, 2022, had a working capital deficit of approximately $1,978,396 at December 31, 2022, had net losses
of $2,929,817 and $3,004,619 for the years ended December 31, 2022 and 2021, respectively, and net cash used in operating activities
of $1,830,242 and $1,774,182 for the years ended December 31, 2022 and 2021, respectively, with no revenue earned since inception, and
a lack of operational history. These matters raise substantial doubt about the Company’s ability to continue as a going concern.
While
the Company is attempting to expand operations and increase revenues, the Company’s cash position may not be significant enough
to support the Company’s daily operations. Management intends to raise additional funds by way of a public offering or an asset
sale transaction. Management believes that the actions presently being taken to further implement its business plan and generate revenues
provide the opportunity for the Company to continue as a going concern. While management believes in the viability of its strategy to
generate revenues and in its ability to raise additional funds or transact an asset sale, there can be no assurances to that effect or
on terms acceptable to the Company. The ability of the Company to continue as a going concern is dependent upon the Company’s ability
to further implement its business plan and generate revenues.
The
financial statements do not include any adjustments that might be necessary if the Company is unable to continue as a going concern.
NOTE
3 – SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES
This
summary of significant accounting policies of the Company is presented to assist in understanding the Company’s financial statements.
The financial statements and notes are representations of the Company’s management, which is responsible for their integrity and
objectivity. These accounting policies conform to GAAP and have been consistently applied in the preparation of the financial statements.
Use
of Estimates
The
preparation of these financial statements in accordance with accounting principles generally accepted in the United States of America
requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosures of contingent
assets and liabilities at the dates of the financial statements and the reported amounts of net sales and expenses during the reported
periods. Actual results may differ from those estimates and such differences may be material to the financial statements. The more significant
estimates and assumptions by management include among others: common stock valuation, and the recoverability of intangibles. The current
economic environment has increased the degree of uncertainty inherent in these estimates and assumptions.
Cash
The
Company’s cash is held in bank accounts in the United States and is insured by the Federal Deposit Insurance Corporation (FDIC)
up to $250,000. The Company has not experienced any cash losses.
Income
Taxes
Income
taxes are accounted for under an asset and liability approach. This process involves calculating the temporary and permanent differences
between the carrying amounts of the assets and liabilities for financial reporting purposes and the amounts used for income tax purposes.
The temporary differences result in deferred tax assets and liabilities, which would be recorded on the Balance Sheets in accordance
with ASC 740, which established financial accounting and reporting standards for the effect of income taxes. The likelihood that its
deferred tax assets will be recovered from future taxable income must be assessed and, to the extent that recovery is not likely, a valuation
allowance is established. Changes in the valuation allowance in a period are recorded through the income tax provision in the consolidated
Statements of Operations.
ASC
740-10 clarifies the accounting for uncertainty in income taxes recognized in an entity’s consolidated financial statements and
prescribes a recognition threshold and measurement attributes for financial statement disclosure of tax positions taken or expected to
be taken on a tax return. Under ASC 740-10, the impact of an uncertain income tax position on the income tax return must be recognized
at the largest amount that is more-likely-than-not to be sustained upon audit by the relevant taxing authority. An uncertain income tax
position will not be recognized if it has less than a 50% likelihood of being sustained. Additionally, ASC 740-10 provides guidance on
derecognition, classification, interest and penalties, accounting in interim periods, disclosure and transition. As a result of the implementation
of ASC 740-10 and currently, the Company does not have a liability for unrecognized income tax benefits.
Advertising
and Marketing Costs
Advertising
expenses are recorded as general and administrative expenses when they are incurred. The Company had $457 of advertising expenses for
the year ended December 31, 2022 and had no advertising expenses for the year ended December 31, 2021.
Research
and Development
All
research and development costs are expensed as incurred. The Company incurred research and development expense of $657,657 and $734,014
for the years ended December 31, 2022 and 2021, respectively.
Inventories
In
conjunction with the October 19, 2020 Share Exchange Agreement, the Company kept the gem inventory of Reign Resources Corporation. Inventories
are stated at the lower of cost or market (net realizable value) on a lot basis each quarter. A lot is determined by the cut, clarity,
size, and weight of the sapphires. Inventory consists of sapphire jewels that meet rigorous grading criteria and are of cuts and sizes
most commonly used in the jewelry industry. As of December 31, 2022 and 2021, the Company carried primarily loose sapphire jewels, jewelry
for sale on our website, and jewelry held as samples. Samples are used to show potential customers what the jewelry would look like.
Promotional items given to customers that are not expected to be returned will be removed from inventory and expensed. There have been
no promotional items given to customers as of December 31, 2022. The Company performs its own in-house assessment based on gem guide
and the current market price for metals to value its inventory on an annual basis or if circumstances dictate sooner to determine if
the estimated fair value is greater or less than cost. In addition, the inventory is reviewed each quarter by the Company against industry
prices from gem-guide and if there is a potential impairment, the Company would appraise the inventory. The estimated fair value is subject
to significant change due to changes in popularity of cut, perceived grade of the clarity of the sapphires, the number, type and size
of inclusions, the availability of other similar quality and size sapphires, and other factors. As a result, the internal assessed value
of the sapphires could be significantly lower from the current estimated fair value. Loose sapphire jewels do not degrade in quality
over time.
Based
on the significant advancement of Sigyn Therapy, the Company decided in the 4th quarter of 2021 to assess the value of retail
business operations that were a focus of the Company prior to the merger transaction consummated on October 19, 2020.
Related
to this assessment, management determined the wholesale liquidation value of its sapphire gem inventory to be 5-10% of the previously
reported retail value, based on communications with certified gemologists, the variance between retail and wholesale valuations, and
current market conditions. As a result, the Company has valued the inventory at $50,000 and recorded an impairment of assets of $536,047
in the year ended December 31, 2021.
Property
and Equipment
Property
and equipment are carried at cost and are depreciated on a straight-line basis over the estimated useful lives of the assets, generally
five years. The cost of repairs and maintenance is expensed as incurred; major replacements and improvements are capitalized. When assets
are retired or disposed of, the cost and accumulated depreciation are removed from the accounts, and any resulting gains or losses are
included in income in the year of disposition.
Intangible
Assets
Intangible
assets consist primarily of website development costs. Our intangible assets are being amortized on a straight-line basis over a period
of three years.
Impairment
of Long-lived Assets
We
periodically evaluate whether the carrying value of property, equipment and intangible assets has been impaired when circumstances indicate
the carrying value of those assets may not be recoverable. The carrying amount is not recoverable if it exceeds the sum of the undiscounted
cash flows expected to result from the use and eventual disposition of the asset. If the carrying value is not recoverable, the impairment
loss is measured as the excess of the asset’s carrying value over its fair value.
Our
impairment analyses require management to apply judgment in estimating future cash flows as well as asset fair values, including forecasting
useful lives of the assets, assessing the probability of different outcomes, and selecting the discount rate that reflects the risk inherent
in future cash flows. If the carrying value is not recoverable, we assess the fair value of long-lived assets using commonly accepted
techniques, and may use more than one method, including, but not limited to, recent third-party comparable sales and discounted cash
flow models. If actual results are not consistent with our assumptions and estimates, or our assumptions and estimates change due to
new information, we may be exposed to an impairment charge in the future. As of December 31, 2022 and 2021, the Company had not experienced
impairment losses on its long-lived assets.
Fair
Value of Financial Instruments
The
provisions of accounting guidance, FASB Topic ASC 825 requires all entities to disclose the fair value of financial instruments, both
assets and liabilities recognized and not recognized on the balance sheet, for which it is practicable to estimate fair value, and defines
fair value of a financial instrument as the amount at which the instrument could be exchanged in a current transaction between willing
parties. As of December 31, 2022 and 2021, the fair value of cash, accounts payable, accrued expenses, and notes payable approximated
carrying value due to the short maturity of the instruments, quoted market prices or interest rates which fluctuate with market rates.
Fair
Value Measurements
Fair
value is defined as the exchange price that would be received for an asset or paid to transfer a liability (an exit price) in the principal
or most advantageous market for the asset or liability, in an orderly transaction between market participants on the measurement date.
Valuation techniques used to measure fair value must maximize the use of observable inputs and minimize the use of unobservable inputs.
The fair value hierarchy is based on three levels of inputs, of which the first two are considered observable and the last unobservable,
as follows:
|
● |
Level 1 – Quoted
prices in active markets for identical assets or liabilities. |
|
● |
Level 2 – Inputs
other than Level 1 that are observable, either directly or indirectly, such as quoted prices for similar assets or liabilities; quoted
prices in markets that are not active; or other inputs that are observable or can be corroborated by observable market data for substantially
the full term of the assets or liabilities. |
|
|
|
|
● |
Level 3 – Unobservable
inputs that are supported by little or no market activity and that are significant to the measurement of the fair value of the assets
or liabilities |
The
carrying value of financial assets and liabilities recorded at fair value are measured on a recurring or nonrecurring basis. Financial
assets and liabilities measured on a non-recurring basis are those that are adjusted to fair value when a significant event occurs. There
were no financial assets or liabilities carried and measured on a nonrecurring basis during the reporting periods. Financial assets and
liabilities measured on a recurring basis are those that are adjusted to fair value each time a financial statement is prepared. There
have been no transfers between levels.
Debt
The
Company issues debt that may have separate warrants, conversion features, or no equity-linked attributes.
Embedded
Conversion Features
The
Company evaluates embedded conversion features within convertible debt under ASC 815, Derivatives and Hedging, to determine whether
the embedded conversion feature(s) should be bifurcated from the host instrument and accounted for as a derivative at fair value with
changes in fair value recorded in earnings. If the conversion feature does not require derivative treatment under ASC 815, the instrument
is evaluated under ASC 470-20, Debt with Conversion and Other Options, for consideration of any beneficial conversion feature.
Derivative
Financial Instruments
The
Company evaluates all of it financial instruments, including stock purchase warrants, to determine if such instruments are derivatives
or contain features that qualify as embedded derivatives. For derivative financial instruments that are accounted for as liabilities,
the derivative instrument is initially recorded at its fair value and is then re-valued at each reporting date, with changes in the fair
value reported as charges or credits to income.
For
option-based simple derivative financial instruments, the Company uses the Monte Carlo simulations to value the derivative instruments
at inception and subsequent valuation dates. The classification of derivative instruments, including whether such instruments should
be recorded as liabilities or as equity, is re-assessed at the end of each reporting period. There were no derivative financial instruments
as of December 31, 2022 and 2021 and no charges or credits to income for the years ended December 31, 2022 and 2021.
Debt
Issue Costs and Debt Discount
The
Company may record debt issue costs and/or debt discounts in connection with raising funds through the issuance of debt. These costs
may be paid in the form of cash or equity (such as warrants). These costs are amortized to interest expense through the maturity of the
debt. If a conversion of the underlying debt occurs prior to maturity a proportionate share of the unamortized amounts is immediately
expensed. Any unamortized debt issue costs and debt discount are presented net of the related debt on the consolidated balance sheets.
Original
Issue Discount
For
certain convertible debt issued, the Company may provide the debt holder with an original issue discount. The original issue discount
would be recorded to debt discount, reducing the face amount of the note and is amortized to interest expense through the maturity of
the debt. If a conversion of the underlying debt occurs prior to maturity a proportionate share of the unamortized amounts is immediately
expensed. Any unamortized original issue discounts are presented net of the related debt on the consolidated balance sheets.
If
the conversion feature does not qualify for either the derivative treatment or as a BCF, the convertible debt is treated as traditional
debt.
Basic
and diluted earnings per share
Basic
net loss per share is calculated by dividing the net loss by the weighted-average number of common shares outstanding for the period,
without consideration for common stock equivalents. Diluted earnings (loss) per share are computed on the basis of the weighted average
number of common shares (including common stock subject to redemption) plus dilutive potential common shares outstanding for the reporting
period. In periods where losses are reported, the weighted-average number of common stock outstanding excludes common stock equivalents,
because their inclusion would be anti-dilutive.
Basic
and diluted earnings (loss) per share are the same since net losses for all periods presented and including the additional potential
common shares would have an anti-dilutive effect.
Stock
Based Compensation
In
accordance with ASC No. 718, Compensation – Stock Compensation (“ASC 718”), we measure the compensation costs
of share-based compensation arrangements based on the grant-date fair value and recognize the costs in the financial statements over
the period during which employees are required to provide services. Share-based compensation arrangements include stock options, restricted
share plans, performance-based awards, share appreciation rights and employee share purchase plans. As such, compensation cost is measured
on the date of grant at their fair value. Such compensation amounts, if any, are amortized over the respective vesting periods of the
option grant.
Non-Employee
Stock-Based Compensation
In
accordance with ASC 505, Equity Based Payments to Non-Employees, issuances of the Company’s common stock or warrants for
acquiring goods or services are measured at the fair value of the consideration received or the fair value of the equity instruments
issued, whichever is more reliably measurable. The measurement date for the fair value of the equity instruments issued to consultants
or vendors is determined at the earlier of (i) the date at which a commitment for performance to earn the equity instruments is reached
(a “performance commitment” which would include a penalty considered to be of a magnitude that is a sufficiently large disincentive
for nonperformance) or (ii) the date at which performance is complete. Although situations may arise in which counter performance may
be required over a period of time, the equity award granted to the party performing the service is fully vested and non-forfeitable on
the date of the agreement. As a result, in this situation in which vesting periods do not exist as the instruments fully vested on the
date of agreement, the Company determines such date to be the measurement date and will record the estimated fair market value of the
instruments granted as a prepaid expense and amortize such amount to general and administrative expense in the accompanying statement
of operations over the contract period. When it is appropriate for the Company to recognize the cost of a transaction during financial
reporting periods prior to the measurement date, for purposes of recognition of costs during those periods, the equity instrument is
measured at the then-current fair values at each of those interim financial reporting dates.
Reclassifications
An
adjustment has been made to the Consolidated Balance Sheets as of December 31, 2021, to reclass $1,072 of other current liabilities previously
classified in accrued payroll and payroll taxes. These reclassifications had no effect on the reported results of operations.
Concentrations,
Risks, and Uncertainties
Business
Risk
Substantial
business risks and uncertainties are inherent to an entity, including the potential risk of business failure.
The
Company is headquartered and operates in the United States. To date, the Company has generated no revenues from operations. There can
be no assurance that the Company will be able to raise additional capital and failure to do so would have a material adverse effect on
the Company’s financial position, results of operations and cash flows. Also, the success of the Company’s operations is
subject to numerous contingencies, some of which are beyond management’s control. Currently, these contingencies include general
economic conditions, price of components, competition, and governmental and political conditions.
Interest
rate risk
Financial
assets and liabilities do not have material interest rate risk.
Credit
risk
The
Company is exposed to credit risk from its cash in banks. The credit risk on cash in banks is limited because the counterparties are
recognized financial institutions.
Seasonality
The
business is not subject to substantial seasonal fluctuations.
Major
Suppliers
Sigyn
Therapy is comprised of components that are supplied by various industry vendors. Additionally, the Company is reliant on third-party
organizations to conduct clinical development studies that are necessary to advance Sigyn Therapy toward the marketplace.
Should
the relationship with an industry vendor or third-party clinical development organization be interrupted or discontinued, it is believed
that alternate component suppliers and third-party clinical development organizations could be identified to support the continued advancement
of Sigyn Therapy.
Recent
Accounting Pronouncements
In
August 2020, the FASB issued ASU No. 2020-06, Debt-Debt with Conversion and Other Options (Subtopic 470-20) and Derivatives and Hedging
– Contracts in Entity’s Own Equity (Subtopic 815-40): Accounting for Convertible Instruments and Contracts in an Entity’s
Own Equity, which simplifies accounting for convertible instruments by removing major separation models required under current GAAP.
The ASU removes certain settlement conditions that are required for equity contracts to qualify for the derivative scope exception and
it also simplifies the diluted earnings per share calculation in certain areas. This ASU is effective for annual reporting periods beginning
after December 15, 2021, including interim periods within those fiscal years. Early adoption is permitted, but no earlier than fiscal
years beginning after December 15, 2020. The Company adopted ASU No. 2020-06 in the first quarter
of fiscal 2021, coinciding with the standard’s effective date, and had an immaterial impact from this standard.
Other
recently issued accounting updates are not expected to have a material impact on the Company’s consolidated financial statements.
NOTE
4 – PROPERTY AND EQUIPMENT
Property
and equipment consisted of the following as of:
SCHEDULE
OF PROPERTY AND EQUIPMENT
| |
Estimated Life | |
December 31, 2022 | | |
December 31, 2021 | |
| |
| |
| | |
| |
Office equipment | |
5 years | |
$ | 29,041 | | |
$ | 28,181 | |
Computer equipment | |
3 years | |
| 3,157 | | |
| 3,157 | |
Accumulated depreciation | |
| |
| (10,146 | ) | |
| (3,292 | ) |
Property and equipment,
net | |
| |
$ | 22,052 | | |
$ | 28,046 | |
Depreciation
expense was $6,854 and $2,946 for the years ended December 31, 2022 and 2021, respectively, and is classified in general and administrative
expenses in the Consolidated Statements of Operations.
NOTE
5 – INTANGIBLE ASSETS
Intangible
assets consisted of the following as of:
SCHEDULE
OF INTANGIBLE ASSETS
| |
Estimated life | |
December 31, 2022 | | |
December 31, 2021 | |
Website | |
3 years | |
$ | 10,799 | | |
$ | 10,799 | |
Accumulated amortization | |
| |
| (8,699 | ) | |
| (5,099 | ) |
Intangible assets, net | |
| |
$ | 2,100 | | |
$ | 5,700 | |
As
of December 31, 2022, estimated future amortization expenses related to intangible assets were as follows:
SCHEDULE
OF ESTIMATED AMORTIZATION EXPENSES RELATED TO INTANGIBLE ASSETS
| |
Intangible Assets | |
2023 | |
$ | 2,100 | |
Intangible
assets, net | |
$ | 2,100 | |
The
Company had amortization expense of $3,600 and $16,205 for the years ended December 31, 2022 and 2021, respectively.
On
January 8, 2020, James Joyce, the Company’s CEO and Craig Roberts, the Company’s CTO, assigned to the Company the rights
to patent 62/881,740 pertaining to the devices, systems and methods for the broad-spectrum reduction of pro-inflammatory cytokines in
blood.
NOTE
6 – CONVERTIBLE PROMISSORY DEBENTURES
Convertible
notes payable consisted of the following:
SCHEDULE
OF CONVERTIBLE NOTES PAYABLE
| |
December
30, 2022 | | |
December
31, 2021 | |
| |
| | |
| |
January 28, 2020 ($457,380) – 0% interest per annum outstanding principal and interest due October 20, 2022 (“Note 1”) | |
$ | 457,380 | | |
$ | 457,380 | |
January 28, 2020 ($457,380) – 0% interest per annum outstanding principal and interest due October 20, 2022 (“Note 1”) | |
$ | 457,380 | | |
$ | 457,380 | |
June 23, 2020 ($60,500) – 0% interest per annum outstanding principal and interest due October 20, 2022 (“Note 2”) | |
| 60,500 | | |
| 60,500 | |
September 17, 2020 ($199,650) – 0% interest per annum outstanding principal and interest due October 20, 2022. On October 28, 2021, Osher elected to convert $16,714 of the aggregate principal amount of the Note of $199,650, into 42,857 common shares (“Note 3”). | |
| 182,936 | | |
| 182,936 | |
March 23, 2022 ($220,000) – 0% interest per annum outstanding principal and interest due March 23, 2023 (“Note 4”) | |
| 220,000 | | |
| - | |
April 28, 2022 ($110,000) – 0% interest per annum outstanding principal and interest due April 28, 2023 (“Note 5”) | |
| 110,000 | | |
| - | |
May 10, 2022 ($110,000) – 0% interest per annum outstanding principal and interest due May 10, 2023 (“Note 6”) | |
| 110,000 | | |
| - | |
June 1, 2022 ($55,000) – 0% interest per annum outstanding principal and interest due June 1, 2023 (“Note 7”) | |
| 55,000 | | |
| - | |
June 22, 2022 ($82,500) – 0% interest per annum outstanding principal and interest due June 22, 2023 (“Note 8”) | |
| 82,500 | | |
| - | |
July 2022 ($341,000) – 0% interest per annum outstanding principal and interest due various dates July 2023 (“Note 9”) | |
| 341,000 | | |
| - | |
August 31, 2022 ($110,000) – 0% interest per annum outstanding principal and interest due August 31, 2023 (“Note 10”) | |
| 110,000 | | |
| - | |
September 9, 2022 ($82,500) – 0% interest per annum outstanding principal and interest due September 9, 2023 (“Note 11”) | |
| 82,500 | | |
| - | |
September 20, 2022 ($110,000) – 0% interest per annum outstanding principal and interest due September 20, 2023 (“Note 12”) | |
| 110,000 | | |
| - | |
October 20, 2022 ($110,000) – 0% interest per annum outstanding principal and interest due October 20, 2023 (“Note 13”) | |
| 110,000 | | |
| - | |
November 9, 2022 ($82,500) – 0% interest per annum outstanding principal and interest due November 9, 2023 (“Note 14”) | |
| 82,500 | | |
| - | |
November 14, 2022 ($55,000) – 0% interest per annum outstanding principal and interest due November 14, 2023 (“Note 15”) | |
| 55,000 | | |
| - | |
December 22, 2022 ($110,000) – 0% interest per annum outstanding principal and interest due September 9, 2023 (“Note 16”) | |
| 110,000 | | |
| - | |
| |
| | | |
| | |
Total convertible notes payable | |
| 2,279,316 | | |
| 700,816 | |
Original issue discount | |
| (74,502 | ) | |
| (53,614 | ) |
Beneficial conversion feature | |
| (175,275 | ) | |
| - | |
Debt discount | |
| (392,883 | ) | |
| - | |
| |
| | | |
| | |
Total convertible notes payable | |
$ | 1,636,656 | | |
$ | 647,202 | |
Principal
payments on convertible promissory debentures are due as follows:
SCHEDULE OF PRINCIPAL PAYMENTS DUE ON CONVERTIBLE PROMISSORY DEBENTURES
Year ending December 31, | |
| |
2024 | |
$ | 2,279,316 | |
Long-Term
Debt | |
$ | 2,279,316 | |
Changes
in convertible notes were as follows:
SCHEDULE
OF CHANGES IN CONVERTIBLE NOTES
| |
Note
1 | | |
Note
2 | | |
Note
3 | | |
Note
4 | | |
Note
5 | | |
Note
6 | | |
Note
7 | | |
Note
8 | | |
Note
9 | | |
Note
10 | | |
Note
11 | | |
Note
12 | | |
Note
13 | | |
Note
14 | | |
Note
15 | | |
Note
16 | | |
Other | | |
Totals | |
Convertible
notes payable as of January 1, 2021 | |
$ | 385,000 | | |
$ | 50,000 | | |
$ | 181,500 | | |
$ | - | | |
$ | - | | |
$ | - | | |
$ | - | | |
$ | - | | |
$ | - | | |
$ | - | | |
$ | - | | |
$ | - | | |
$ | - | | |
$ | - | | |
$ | - | | |
$ | - | | |
$ | - | | |
$ | 616,500 | |
Extension
of convertible note payable | |
| 72,380 | | |
| 10,500 | | |
| 18,150 | | |
| - | | |
| - | | |
| - | | |
| - | | |
| - | | |
| - | | |
| - | | |
| - | | |
| - | | |
| - | | |
| - | | |
| - | | |
| - | | |
| - | | |
| 101,030 | |
Exchange
of convertible note payable for common stock | |
| - | | |
| - | | |
| (16,714 | ) | |
| - | | |
| - | | |
| - | | |
| - | | |
| - | | |
| - | | |
| - | | |
| - | | |
| - | | |
| - | | |
| - | | |
| - | | |
| - | | |
| - | | |
| (16,714 | ) |
Convertible
notes payable, net, as of December 31, 2021 | |
| 457,380 | | |
| 60,500 | | |
| 182,936 | | |
| - | | |
| - | | |
| - | | |
| - | | |
| - | | |
| - | | |
| - | | |
| - | | |
| - | | |
| - | | |
| - | | |
| - | | |
| - | | |
| - | | |
| 700,816 | |
| |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | |
Convertible
notes payable issued in 2022 | |
| - | | |
| - | | |
| - | | |
| 220,000 | | |
| 110,000 | | |
| 110,000 | | |
| 55,000 | | |
| 82,500 | | |
| 341,000 | | |
| 110,000 | | |
| 82,500 | | |
| 110,000 | | |
| 110,000 | | |
| 82,500 | | |
| 55,000 | | |
| 110,000 | | |
| - | | |
| 1,578,500 | |
Convertible
notes payable as of December 31, 2022 | |
$ | 457,380 | | |
$ | 60,500 | | |
$ | 182,936 | | |
$ | 220,000 | | |
$ | 110,000 | | |
$ | 110,000 | | |
$ | 55,000 | | |
$ | 82,500 | | |
$ | 341,000 | | |
$ | 110,000 | | |
$ | 82,500 | | |
$ | 110,000 | | |
$ | 110,000 | | |
$ | 82,500 | | |
$ | 55,000 | | |
$ | 110,000 | | |
$ | - | | |
$ | 2,279,316 | |
Changes
in note discounts were as follows:
SCHEDULE OF CHANGES IN NOTE DISCOUNTS
| |
Note
1 | | |
Note
2 | | |
Note
3 | | |
Note
4 | | |
Note
5 | | |
Note
6 | | |
Note
7 | | |
Note
8 | | |
Note
9 | | |
Note
10 | | |
Note
11 | | |
Note
12 | | |
Note
13 | | |
Note
14 | | |
Note
15 | | |
Note
16 | | |
Other | | |
Totals | |
Note discounts as of January 1, 2020 | |
$ | 73,418 | | |
$ | 5,830 | | |
$ | 18,584 | | |
$ | - | | |
$ | - | | |
$ | - | | |
$ | - | | |
$ | - | | |
$ | - | | |
$ | - | | |
$ | - | | |
$ | - | | |
$ | - | | |
$ | - | | |
$ | - | | |
$ | - | | |
$ | - | | |
$ | 97,832 | |
Note discounts in conjunction
with extension of convertible note | |
| 41,580 | | |
| 5,500 | | |
| 18,150 | | |
| - | | |
| - | | |
| - | | |
| - | | |
| - | | |
| - | | |
| - | | |
| - | | |
| - | | |
| - | | |
| - | | |
| - | | |
| - | | |
| - | | |
| 65,230 | |
2021
accretion of note discounts | |
| (80,822 | ) | |
| (6,809 | ) | |
| (21,817 | ) | |
| - | | |
| - | | |
| - | | |
| - | | |
| - | | |
| - | | |
| - | | |
| - | | |
| - | | |
| - | | |
| - | | |
| - | | |
| - | | |
| - | | |
| (109,448 | ) |
Note discounts as of December
31, 2021 | |
| 34,176 | | |
| 4,521 | | |
| 14,917 | | |
| - | | |
| - | | |
| - | | |
| - | | |
| - | | |
| - | | |
| - | | |
| - | | |
| - | | |
| - | | |
| - | | |
| - | | |
| - | | |
| - | | |
| 53,614 | |
| |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | |
Note discounts issued in conjunction
with debt | |
| - | | |
| - | | |
| - | | |
| 113,418 | | |
| 44,786 | | |
| 44,787 | | |
| 22,794 | | |
| 34,861 | | |
| 140,289 | | |
| 64,104 | | |
| 82,500 | | |
| 110,000 | | |
| 110,000 | | |
| 82,500 | | |
| 55,000 | | |
| 110,000 | | |
| - | | |
| 1,015,039 | |
2022
accretion of note discounts | |
| (34,176 | ) | |
| (4,521 | ) | |
| (14,917 | ) | |
| (87,938 | ) | |
| (30,308 | ) | |
| (28,836 | ) | |
| (13,301 | ) | |
| (18,336 | ) | |
| (70,720 | ) | |
| (32,316 | ) | |
| (39,994 | ) | |
| (49,874 | ) | |
| (23,671 | ) | |
| (12,822 | ) | |
| (7,726 | ) | |
| (6,537 | ) | |
| 50,000 | | |
| (425,993 | ) |
accretion of note discounts | |
| (34,176 | ) | |
| (4,521 | ) | |
| (14,917 | ) | |
| (87,938 | ) | |
| (30,308 | ) | |
| (28,836 | ) | |
| (13,301 | ) | |
| (18,336 | ) | |
| (70,720 | ) | |
| (32,316 | ) | |
| (39,994 | ) | |
| (49,874 | ) | |
| (23,671 | ) | |
| (12,822 | ) | |
| (7,726 | ) | |
| (6,537 | ) | |
| 50,000 | | |
| (425,993 | ) |
Note discounts as of December
31, 2022 | |
$ | - | | |
$ | - | | |
$ | - | | |
$ | 25,480 | | |
$ | 14,478 | | |
$ | 15,951 | | |
$ | 9,493 | | |
$ | 16,525 | | |
$ | 69,569 | | |
$ | 31,788 | | |
$ | 42,506 | | |
$ | 60,126 | | |
$ | 86,329 | | |
$ | 69,678 | | |
$ | 47,274 | | |
$ | 103,463 | | |
$ | 50,000 | | |
$ | 592,660 | |
| |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | |
Convertible notes payable,
net, as of December 31, 2021 | |
$ | 423,204 | | |
$ | 55,979 | | |
$ | 168,019 | | |
$ | - | | |
$ | - | | |
$ | - | | |
$ | - | | |
$ | - | | |
$ | - | | |
$ | - | | |
$ | - | | |
$ | - | | |
$ | - | | |
$ | - | | |
$ | - | | |
$ | - | | |
$ | - | | |
$ | 647,202 | |
Convertible notes payable,
net, as of December 31, 2022 | |
$ | 457,380 | | |
$ | 60,500 | | |
$ | 182,936 | | |
$ | 194,520 | | |
$ | 95,522 | | |
$ | 94,049 | | |
$ | 45,507 | | |
$ | 65,975 | | |
$ | 271,431 | | |
$ | 78,212 | | |
$ | 39,994 | | |
$ | 49,874 | | |
$ | 23,671 | | |
$ | 12,822 | | |
$ | 7,726 | | |
$ | 6,537 | | |
$ | (50,000 | ) | |
$ | 1,636,656 | |
| |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | |
2021 Effective interest rate | |
| 11 | % | |
| 11 | % | |
| 12 | % | |
| -% | | |
| -% | | |
| -% | | |
| -% | | |
| -% | | |
| -% | | |
| -% | | |
| -% | | |
| -% | | |
| -% | | |
| -% | | |
| -% | | |
| -% | | |
| -% | | |
| -% | |
2022 Effective interest rate | |
| 7 | % | |
| 7 | % | |
| 8 | % | |
| 40 | % | |
| 28 | % | |
| 26 | % | |
| 24 | % | |
| 22 | % | |
| 21 | % | |
| 29 | % | |
| 48 | % | |
| 45 | % | |
| 22 | % | |
| 16 | % | |
| 14 | % | |
| 6 | % | |
| -% | | |
| 19 | % |
Current
Noteholders
Osher
– $110,000 (Note 16)
On
December 22, 2022, the Company entered into an Original Issue Discount Senior Convertible Debenture (the “Note”) with respect
to the sale and issuance to institutional investor Osher Capital Partners LLC (“Osher”)
of (i) $110,000 aggregate principal amount of Note due December 22, 2023 based on $1.00 for each $0.90909 paid by Osher and (ii) five-year
Common Stock Purchase Warrants (“Warrants’) to purchase up to an aggregate of 733,333 shares of the Company’s Common
Stock at an exercise price of $0.25 per share. The aggregate cash subscription amount received by the Company from Osher for the issuance
of the Note and Warrants was $100,000 which was issued at a $10,000 original issue discount from the face value of the Note. The
conversion price for the principal in connection with voluntary conversions by a holder of the convertible notes is $0.15 per share,
subject to adjustment as provided therein, such as stock splits and stock dividends.
Osher
– $55,000 (Note 15)
On
November 14, 2022, the Company entered into an Original Issue Discount Senior Convertible Debenture (the “Note”) with respect
to the sale and issuance to institutional investor Osher Capital Partners LLC (“Osher”)
of (i) $55,000 aggregate principal amount of Note due November 14, 2023 based on $1.00 for each $0.90909 paid by Osher and (ii) five-year
Common Stock Purchase Warrants (“Warrants’) to purchase up to an aggregate of 366,667 shares of the Company’s Common
Stock at an exercise price of $0.25 per share. The aggregate cash subscription amount received by the Company from Osher noteholder for
the issuance of the Note and Warrants was $50,000 which was issued at a $5,000 original issue discount from the face value of the Note.
The conversion price for the principal in connection with voluntary conversions by a holder of
the convertible notes is $0.15 per share, subject to adjustment as provided therein, such as stock splits and stock dividends.
Brio
– $82,500 (Note 14)
On
November 9, 2022, the Company entered into an Original Issue Discount Senior Convertible Debenture (the “Note”) with respect
to the sale and issuance to institutional investor Brio Capital Master Fund Ltd (“Brio”)
of (i) $82,500 aggregate principal amount of Note due November 9, 2023 based on $1.00 for each $0.90909 paid by Brio and (ii) five-year
Common Stock Purchase Warrants (“Warrants’) to purchase up to an aggregate of 550,000 shares of the Company’s Common
Stock at an exercise price of $0.25 per share. The aggregate cash subscription amount received by the Company from Brio for the issuance
of the Note and Warrants was $75,000 which was issued at a $7,500 original issue discount from the face value of the Note. The
conversion price for the principal in connection with voluntary conversions by a holder of the convertible notes is $0.15 per share,
subject to adjustment as provided therein, such as stock splits and stock dividends.
Osher
– $110,000 (Note 13)
On
October 20, 2022, the Company entered into an Original Issue Discount Senior Convertible Debenture (the “Note”) with respect
to the sale and issuance to institutional investor Osher Capital Partners LLC (“Osher”)
of (i) $110,000 aggregate principal amount of Note due October 20, 2023 based on $1.00 for each $0.90909 paid by Osher and (ii) five-year
Common Stock Purchase Warrants (“Warrants’) to purchase up to an aggregate of 733,333 shares of the Company’s Common
Stock at an exercise price of $0.25 per share. The aggregate cash subscription amount received by the Company from Osher for the issuance
of the Note and Warrants was $100,000 which was issued at a $10,000 original issue discount from the face value of the Note. The
conversion price for the principal in connection with voluntary conversions by a holder of the convertible notes is $0.15 per share,
subject to adjustment as provided therein, such as stock splits and stock dividends.
Osher
– $110,000 (Note 12)
On
September 20, 2022, the Company entered into an Original Issue Discount Senior Convertible Debenture (the “Note”) with respect
to the sale and issuance to institutional investor Osher Capital Partners LLC (“Osher”)
of (i) $110,000 aggregate principal amount of Note due September 20, 2023 based on $1.00 for each $0.90909 paid by Osher and (ii) five-year
Common Stock Purchase Warrants (“Warrants’) to purchase up to an aggregate of 733,333 shares of the Company’s Common
Stock at an exercise price of $0.25 per share. The aggregate cash subscription amount received by the Company from Osher for the issuance
of the Note and Warrants was $100,000 which was issued at a $10,000 original issue discount from the face value of the Note. The
conversion price for the principal in connection with voluntary conversions by a holder of the convertible notes is $0.15 per share,
subject to adjustment as provided therein, such as stock splits and stock dividends.
Brio
– $82,500 (Note 11)
On
September 9, 2022, the Company entered into an Original Issue Discount Senior Convertible Debenture (the “Note”) with respect
to the sale and issuance to institutional investor Brio Capital Master Fund Ltd. (“Brio”)
of (i) $82,500 aggregate principal amount of Note due September 9, 2023 based on $1.00 for each $0.90909 paid by Brio and (ii) five-year
Common Stock Purchase Warrants (“Warrants’) to purchase up to an aggregate of 550,000 shares of the Company’s Common
Stock at an exercise price of $0.25 per share. The aggregate cash subscription amount received by the Company from Brio for the issuance
of the Note and Warrants was $75,000 which was issued at a $7,500 original issue discount from the face value of the Note. The
conversion price for the principal in connection with voluntary conversions by a holder of the convertible notes is $0.15 per share,
subject to adjustment as provided therein, such as stock splits and stock dividends.
Osher
– $110,000 (Note 10)
On
August 31, 2022, the Company entered into an Original Issue Discount Senior Convertible Debenture (the “Note”) with respect
to the sale and issuance to institutional investor Osher Capital Partners LLC (“Osher”)
of (i) $110,000 aggregate principal amount of Note due August 31, 2023 based on $1.00 for each $0.90909 paid by Osher and (ii) five-year
Common Stock Purchase Warrants (“Warrants’) to purchase up to an aggregate of 733,333 shares of the Company’s Common
Stock at an exercise price of $0.25 per share. The aggregate cash subscription amount received by the Company from Osher for the issuance
of the Note and Warrants was $100,000 which was issued at a $10,000 original issue discount from the face value of the Note. The
conversion price for the principal in connection with voluntary conversions by a holder of the convertible notes is $0.15 per share,
subject to adjustment as provided therein, such as stock splits and stock dividends.
Other
– $341,000 (Note 9)
In
July 2022, the Company entered into an Original Issue Discount Senior Convertible Debentures (the “July 2022 Notes”) totaling
(i) $341,000 aggregate principal amount of Note (total of $310,000 cash was received) due in various dates in July 2023 based on $1.00
for each $0.90909 paid by the noteholder and (ii) five-year Common Stock Purchase Warrants (“Warrants’) to purchase up to
an aggregate of 676,936 shares of the Company’s Common Stock at an exercise price of $0.50 per share. The
conversion price for the principal in connection with voluntary conversions by the holders of the convertible notes is $0.50 per share.
Osher
– $82,500 (Note 8)
On
June 22, 2022, the Company entered into an Original Issue Discount Senior Convertible Debenture (the “Note”) with respect
to the sale and issuance to institutional investor Osher Capital Partners LLC (“Osher”)
of (i) $82,500 aggregate principal amount of Note due June 22, 2023 based on $1.00 for each $0.90909 paid by Osher and (ii) five-year
Common Stock Purchase Warrants (“Warrants’) to purchase up to an aggregate of 165,000 shares of the Company’s Common
Stock at an exercise price of $0.50 per share. The aggregate cash subscription amount received by the Company from Osher for the issuance
of the Note and Warrants was $75,000 which was issued at a $7,500 original issue discount from the face value of the Note. The
conversion price for the principal in connection with voluntary conversions by a holder of the convertible notes is $0.50 per share,
subject to adjustment as provided therein, such as stock splits and stock dividends.
Osher
– $55,000 (Note 7)
On
June 1, 2022, the Company entered into an Original Issue Discount Senior Convertible Debenture (the “Note”) with respect
to the sale and issuance to institutional investor Osher Capital Partners LLC (“Osher”)
of (i) $55,000 aggregate principal amount of Note due June 1, 2023 based on $1.00 for each $0.90909 paid by Osher and (ii) five-year
Common Stock Purchase Warrants (“Warrants’) to purchase up to an aggregate of 110,000 shares of the Company’s Common
Stock at an exercise price of $0.50 per share. The aggregate cash subscription amount received by the Company from Osher for the issuance
of the Note and Warrants was $50,000 which was issued at a $5,000 original issue discount from the face value of the Note. The
conversion price for the principal in connection with voluntary conversions by a holder of the convertible notes is $0.50 per share,
subject to adjustment as provided therein, such as stock splits and stock dividends.
Brio
– $110,000 (Note 6)
On
May 10, 2022, the Company entered into an Original Issue Discount Senior Convertible Debenture (the “Note”) with respect
to the sale and issuance to institutional investor Brio Capital Master Fund Ltd. (“Brio”)
of (i) $110,000 aggregate principal amount of Note due May 10, 2023 based on $1.00 for each $0.90909 paid by Brio and (ii) five-year
Common Stock Purchase Warrants (“Warrants’) to purchase up to an aggregate of 220,000 shares of the Company’s Common
Stock at an exercise price of $0.50 per share. The aggregate cash subscription amount received by the Company from Brio for the issuance
of the Note and Warrants was $100,000 which was issued at a $10,000 original issue discount from the face value of the Note. The
conversion price for the principal in connection with voluntary conversions by a holder of the convertible notes is $0.50 per share,
subject to adjustment as provided therein, such as stock splits and stock dividends.
Osher
– $110,000 (Note 5)
On
April 28, 2022, the Company entered into an Original Issue Discount Senior Convertible Debenture (the “Note”) with respect
to the sale and issuance to institutional investor Osher Capital Partners LLC (“Osher”)
of (i) $110,000 aggregate principal amount of Note due April 28, 2023 based on $1.00 for each $0.90909 paid by Osher and (ii) five-year
Common Stock Purchase Warrants (“Warrants’) to purchase up to an aggregate of 220,000 shares of the Company’s Common
Stock at an exercise price of $0.50 per share. The aggregate cash subscription amount received by the Company from Osher for the issuance
of the Note and Warrants was $100,000 which was issued at a $10,000 original issue discount from the face value of the Note. The
conversion price for the principal in connection with voluntary conversions by a holder of the convertible notes is $0.50 per share,
subject to adjustment as provided therein, such as stock splits and stock dividends.
Osher
– $110,000 (Note 4)
On
March 23, 2022, the Company entered into an Original Issue Discount Senior Convertible Debenture (the “Note”) with respect
to the sale and issuance to institutional investor Osher Capital Partners LLC (“Osher”)
of (i) $110,000 aggregate principal amount of Note due March 23, 2023 based on $1.00 for each $0.90909 paid by Osher and (ii) five-year
Common Stock Purchase Warrants (“Warrants’) to purchase up to an aggregate of 220,000 shares of the Company’s Common
Stock at an exercise price of $0.50 per share. The aggregate cash subscription amount received by the Company from Osher for the issuance
of the Note and Warrants was $100,000 which was issued at a $10,000 original issue discount from the face value of the Note. The
conversion price for the principal in connection with voluntary conversions by a holder of the convertible notes is $0.50 per share,
subject to adjustment as provided therein, such as stock splits and stock dividends.
The
Company has not repaid this convertible note and the convertible note is now in default. The Company is currently in discussions to restructure
the terms of the note.
Brio
– $110,000 (Note 4)
On
March 23, 2022, the Company entered into an Original Issue Discount Senior Convertible Debenture (the “Note”) with respect
to the sale and issuance to institutional investor Brio Capital Master Fund Ltd. (“Brio”)
of (i) $110,000 aggregate principal amount of Note due March 23, 2023 based on $1.00 for each $0.90909 paid by Brio and (ii) five-year
Common Stock Purchase Warrants (“Warrants’) to purchase up to an aggregate of 220,000 shares of the Company’s Common
Stock at an exercise price of $0.50 per share. The aggregate cash subscription amount received by the Company from Brio for the issuance
of the Note and Warrants was $100,000 which was issued at a $10,000 original issue discount from the face value of the Note. The
conversion price for the principal in connection with voluntary conversions by a holder of the convertible notes is $0.50 per share,
subject to adjustment as provided therein, such as stock splits and stock dividends.
The
Company has not repaid this convertible note and the convertible note is now in default. The Company is currently in discussions to restructure
the terms of the note.
Osher
– $199,650 (Note 3)
On
September 17, 2020 (the “Original Issue Date”), the Company entered into a Securities Purchase Agreement (the “Purchase
Agreement”) with respect to the sale and issuance to institutional investor Osher Capital
Partners LLC (“Osher”) of (i) $181,500 aggregate principal amount of Original Issue Discount Senior Convertible Debenture
(the “Note”) due September 30, 2021, based on $1.00 for each $0.90909 paid by Osher and (ii) five-year Common Stock Purchase
Warrants (“Warrants’) to purchase up to an aggregate of 8,250 shares of the Company’s Common Stock at an exercise price
of $30.00 per share. The aggregate cash subscription amount received by the Company from Osher for the issuance of the Note and Warrants
was $165,000 which was issued at a $16,500 original issue discount from the face value of the Note. The
conversion price for the principal in connection with voluntary conversions by a holder of the convertible notes is $0.39 per share,
as amended on October 20, 2020, subject to adjustment as provided therein, such as stock splits and stock dividends.
The
Company and Osher amended the convertible debt agreement as follows on October 20, 2020:
|
● |
The parties amended the
Warrants dated September 17, 2020, for the number of warrant shares from 8,250 warrant shares to 465,366 warrant shares at an exercise
price of $0.59 per share. |
|
|
|
|
● |
The parties amended the
Note for the maturity date from September 30, 2021 to October 20, 2021. |
On
October 22, 2021, the Company and Osher amended convertible debt agreements as follows:
|
● |
The parties amended the
October 20, 2020 Notes for the maturity date from October 20, 2021 to October 20, 2022. |
|
|
|
|
● |
The parties amended the
October 20, 2020 Notes for the aggregate principal amount and accrued interest from $652,300 to $717,530 which is issued at a $65,230
original issue discount from the face value of the October 20, 2020 Notes now due October 20, 2022. |
|
|
|
|
● |
In exchange for the extension
of the Note, the Company issued Osher five-year warrants to purchase an aggregate of 450,000 shares of the Company’s common
stock at an exercise price of $1.00 per share. |
On
October 28, 2021, Osher elected to convert $16,714 of the aggregate principal amount of the Note of $199,650, into 42,857 common shares.
The
Company has not repaid this convertible note and the convertible note is now in default. The Company is currently in discussions to restructure
the terms of the note.
Osher
– $60,500 (as amended on October 20, 2020 to $55,000) (Note 2)
On
June 23, 2020 (the “Original Issue Date”), the Company entered into a Securities Purchase Agreement (the “Purchase
Agreement”) with respect to the sale and issuance to institutional investor Osher Capital
Partners LLC (“Osher”) of (i) $50,000 aggregate principal amount of Original Issue Discount Senior Convertible Debenture
(the “Note”) due June 23, 2021, based on $1.00 for each $0.90909 paid by Osher and (ii) five-year Common Stock Purchase Warrants
(“Warrants”) to purchase up to an aggregate of 10,000 shares of the Company’s Common Stock at an exercise price of
$30.00 per share. The aggregate cash subscription amount received by the Company from Osher for the issuance of the Note and Warrants
was $50,005 which was issued at a $0 original issue discount from the face value of the Note. The
conversion price for the principal in connection with voluntary conversions by a holder of the convertible notes is $0.39 per share,
as amended on October 20, 2020, subject to adjustment as provided therein, such as stock splits and stock dividends.
The
Company and Osher amended the convertible debt agreement as follows on October 20, 2020:
|
● |
The parties amended the
Note for the aggregate principal amount from $50,000 to $55,000. The aggregate cash subscription amount received by the Company from
Osher for the issuance of the Note and Warrants was $50,005 which was issued at an amended $4,995 original issue discount from the
face value of the Note. |
|
|
|
|
● |
The parties amended the
Warrants dated June 23, 2020, for the number of warrant shares from 10,000 warrant shares to 141,020 warrant shares at an exercise
price of $0.59 per share. |
|
|
|
|
● |
The parties amended the
Note for the maturity date from June 23, 2021 to October 20, 2021. |
On
October 22, 2021, the Company and Osher amended convertible debt agreements as follows (see Note 12):
|
● |
The parties amended the
October 20, 2020 Notes for the maturity date from October 20, 2021 to October 20, 2022. |
|
|
|
|
● |
The parties amended the
October 20, 2020 Notes for the aggregate principal amount and accrued interest from $652,300 to $717,530 which is issued at a $65,230
original issue discount from the face value of the October 20, 2020 Notes now due October 20, 2022. |
|
|
|
|
● |
In exchange for the extension
of the Note, the Company issued Osher five-year warrants to purchase an aggregate of 450,000 shares of the Company’s common
stock at an exercise price of $1.00 per share. |
The
Company has not repaid this convertible note and the convertible note is now in default. The Company is currently in discussions to restructure
the terms of the note.
Osher
– $457,380 (Note 1)
On
January 28, 2020 (the “Original Issue Date”), the Company entered into a Securities Purchase Agreement (the “Purchase
Agreement”) with respect to the sale and issuance to institutional investor Osher Capital
Partners LLC (“Osher”) of (i) $385,000 aggregate principal amount of Original Issue Discount Senior Convertible Debenture
due January 26, 2021, based on $1.00 for each $0.90909 paid by Osher and (ii) five-year Common Stock Purchase Warrants to purchase up
to an aggregate of 80,209 shares of the Company’s Common Stock at an exercise price of $7.00 per share. The aggregate cash subscription
amount received by the Company from Osher for the issuance of the note and warrants was $350,005 which was issued at a $34,995 original
issue discount from the face value of the Note. The conversion price for the principal in connection
with voluntary conversions by a holder of the convertible notes is $0.094 per share, as amended on October 20, 2020, subject to adjustment
as provided therein, such as stock splits and stock dividends.
The
Company and Osher amended the convertible debt agreement as follows on October 20, 2020:
|
● |
The parties amended the
Warrants dated January 28, 2020, for the number of warrant shares from 80,209 warrant shares to 4,113,083 warrant shares at an exercise
price of $0.14 per share. |
|
|
|
|
● |
The parties amended the
Note to provide for interest at 8% per annum. |
|
|
|
|
● |
The parties amended the
Note for the maturity date from June 23, 2021 to October 20, 2021. |
On
October 22, 2021, the Company and Osher amended convertible debt agreements as follows:
|
● |
The parties amended the
October 20, 2020 Notes for the maturity date from October 20, 2021 to October 20, 2022. |
|
|
|
|
● |
The parties amended the
October 20, 2020 Notes for the aggregate principal amount and accrued interest from $652,300 to $717,530 which is issued at a $65,230
original issue discount from the face value of the October 20, 2020 Notes now due October 20, 2022. |
|
|
|
|
● |
In exchange for the extension
of the Note, the Company issued Osher five-year warrants to purchase an aggregate of 450,000 shares of the Company’s common
stock at an exercise price of $1.00 per share. |
The
Company has not repaid this convertible note and the convertible note is now in default. The Company is currently in discussions to restructure
the terms of the note.
Previous
Noteholders
Other
– $145,200
On
November 21, 2022, the Company entered into an Original Issue Discount Senior Convertible Debenture (the “Note”) with a third
party investor of (i) $145,200 aggregate principal amount of Note due November 21, 2023 based on $1.00 for each $0.90909 paid by the
previous noteholder and (ii) five-year Common Stock Purchase Warrants (“Warrants’) to purchase up to an aggregate of 968,000
shares of the Company’s Common Stock at an exercise price of $0.25 per share. The aggregate cash subscription amount received by
the Company from the previous noteholder for the issuance of the Note and Warrants was $132,000 which was issued at a $13,200 original
issue discount from the face value of the Note. The conversion price for the principal in connection
with voluntary conversions by a holder of the convertible notes is $0.15 per share, subject to adjustment as provided therein,
such as stock splits and stock dividends.
On
November 23, 2022, third party investor elected to convert the aggregate principal amount of the Note, $145,200, into 968,000 common
shares.
All
other previous notes were detailed in our Form 10-K filed on March 31, 2022. No changes occurred related to these notes during the period
covered by this Form 10-Q.
NOTE
7 – STOCKHOLDERS’ DEFICIT
Preferred
Stock
The
Company authorized 10,000,000 shares of par value $0.0001 preferred stock, of which none are issued and outstanding at December 31, 2022
and 2021, respectively.
Common
Stock
The
Company has authorized 1,000,000,000 shares of par value $0.0001 common stock, of which 38,263,813 and 37,295,813 shares are outstanding
as of December 31, 2022 and 2021, respectively.
Warrants
On
October 22, 2021, the Company and Osher amended convertible debt agreements for the maturity date from October 20, 2021 to October 20,
2022. In exchange for the extension of the Note, the Company issued Osher 450,000 warrants to purchase an aggregate of 450,000 shares
of the Company’s common stock, valued at $197,501 (based on the Black Scholes valuation model on the date of grant) (see Note 6).
The warrants are exercisable for a period of five years at $1.00 per share in whole or in part, as either a cash exercise or as a cashless
exercise, and fully vest at grant date. The Company accreted the value of the warrants rateably through October 20, 2022. The Company
recorded $147,720 and $40,041 for the years ended December 31, 2022 and 2021, respectively, and is classified in other expenses in the
consolidated Statements of Operations. See Notes 6 for further warrant discussions.
NOTE
8 – OPERATING LEASES
On
May 27, 2021, the Company entered into a sixty-three month lease for its corporate office at $5,955 per month commencing June 15, 2021
maturing September 30, 2026. The Company accounts for this lease in accordance with ASC 842. Adoption
of the standard resulted in the initial recognition of operating lease ROU asset of $290,827 and
operating lease liability of $290,827 as of June 15, 2021.
Operating
lease right-of-use (“ROU”) assets and liabilities are recognized at commencement date based on the present value of lease
payments over the lease term. ROU assets represent our right to use an underlying asset for the lease term and lease liabilities represent
our obligation to make lease payments arising from the lease. Generally, the implicit rate of interest in arrangements is not readily
determinable and the Company utilizes its incremental borrowing rate in determining the present value of lease payments. The Company’s
incremental borrowing rate is a hypothetical rate based on its understanding of what its credit rating would be. The operating lease
ROU asset includes any lease payments made and excludes lease incentives. Our variable lease payments primarily consist of maintenance
and other operating expenses from our real estate leases. Variable lease payments are excluded from the ROU assets and lease liabilities
and are recognized in the period in which the obligation for those payments is incurred. Our lease terms may include options to extend
or terminate the lease when it is reasonably certain that we will exercise that option. Lease expense for minimum lease payments is recognized
on a straight-line basis over the lease term.
We
have lease agreements with lease and non-lease components. We have elected to account for these lease and non-lease components as a single
lease component. We are also electing not to apply the recognition requirements to short-term leases of twelve months or less and instead
will recognize lease payments as expense on a straight-line basis over the lease term.
The
components of lease expense and supplemental cash flow information related to leases for the period are as follows:
In
accordance with ASC 842, the components of lease expense were as follows:
SCHEDULE OF OPERATING LEASE COST AND SUPPLEMENTAL CASH FLOW INFORMATION
| |
2022 | | |
2021 | |
| |
Years ended December 31, | |
| |
2022 | | |
2021 | |
Operating lease expense | |
$ | 71,676 | | |
$ | 41,811 | |
Short term lease cost | |
$ | - | | |
$ | - | |
Total lease expense | |
$ | 71,676 | | |
$ | 41,811 | |
In
accordance with ASC 842, other information related to leases was as follows:
Years ended December 31, | |
2022 | | |
2021 | |
Operating cash flows from operating leases | |
$ | 72,714 | | |
$ | 17,866 | |
Cash paid for amounts included in the measurement of lease liabilities | |
$ | 72,714 | | |
$ | 17,866 | |
| |
| | | |
| | |
Weighted-average remaining lease term—operating leases | |
| 3.67 years | | |
| 4.67 years | |
Weighted-average discount rate—operating leases | |
| 10 | % | |
| 10 | % |
In
accordance with ASC 842, maturities of operating lease liabilities as of December 31, 2022 were as follows:
SCHEDULE OF MATURITIES OF OPERATING LEASE LIABILITIES
| |
Operating | |
Year ending: | |
Lease | |
2023 | |
$ | 74,895 | |
2024 | |
| 77,142 | |
2025 | |
| 79,456 | |
2026 | |
| 54,225 | |
Total undiscounted cash flows | |
$ | 285,718 | |
| |
| | |
Reconciliation of lease liabilities: | |
| | |
Weighted-average remaining lease terms | |
| 3.67 years | |
Weighted-average discount rate | |
| 10 | % |
Present values | |
$ | 240,625 | |
| |
| | |
Lease liabilities—current | |
| 53,200 | |
Lease liabilities—long-term | |
| 187,425 | |
Lease liabilities—total | |
$ | 240,625 | |
| |
| | |
Difference between undiscounted and discounted cash flows | |
$ | 45,093 | |
Operating
lease cost was $71,676 and $41,811 for the years ended December 31, 2022 and 2021, respectively.
NOTE
9 – RELATED PARTY TRANSACTIONS
Other
than as set forth below, and as disclosed in Notes 5 and 7, there have not been any transaction entered into or been a participant in
which a related person had or will have a direct or indirect material interest.
Employment
Agreements
Mr.
Joyce receives an annual base salary of $455,000, plus bonus compensation not to exceed 50% of salary. Mr. Joyce’s employment also
provides for medical insurance, disability benefits and one year of severance pay if his employment is terminated without cause or due
to a change in control. Additionally, the Company has agreed to maintain a beneficial ownership target of 9% for Mr. Joyce. The Company
incurred compensation expense of $453,067 and $496,125 (including $18,542 of 2020 payroll paid in 2021), and employee benefits of $48,811
and $31,126, for the years ended December 31, 2022 and 2021, respectively.
Sigyn
had no employment agreement with its CTO but still incurred compensation on behalf of the CTO. The Company incurred compensation expense
of $233,678 and $259,000, and employee benefits of $25,312 and $21,704, for the years ended December 31, 2022 and 2021, respectively.
NOTE
10 – INCOME TAXES
At
December 31, 2021, net operating loss carry forwards for Federal and state income tax purposes totaling approximately $1,408,000 available
to reduce future income which under the Tax Cuts and Jobs Act of 2018, allows for an indefinite carryforward period, with carryforwards
limited to 80% of each subsequent year’s net income. There is no income tax affect due to the recognition of a full valuation allowance
on the expected tax benefits of future loss carry forwards based on uncertainty surrounding realization of such assets.
A
reconciliation of the statutory income tax rates and the effective tax rate is as follows:
SCHEDULE
OF RECONCILIATION OF STATUTORY INCOME TAX RATES AND EFFECTIVE TAX RATE
| |
December 31, | |
| |
2022 | | |
2021 | |
| |
| | |
| |
Statutory U.S. federal rate | |
| 21.0 | % | |
| 21.0 | % |
State income tax, net of federal benefit | |
| 7.0 | % | |
| 7.0 | % |
Permanent differences | |
| (7.5 | )% | |
| (4.0 | )% |
Valuation allowance | |
| (20.5 | )% | |
| (24.0 | )% |
| |
| | | |
| | |
Provision for income taxes | |
| 0.0 | % | |
| 0.0 | % |
The
tax effects of the temporary differences and carry forwards that give rise to deferred tax assets consist of the following:
SCHEDULE
OF DEFERRED TAX ASSETS
| |
2022 | | |
2021 | |
| |
December 31, | |
| |
2022 | | |
2021 | |
| |
| | |
| |
Deferred tax assets: | |
| | | |
| | |
Net operating loss carry forwards | |
$ | 1,674,531 | | |
$ | 1,073,527 | |
Valuation allowance | |
| (1,674,531 | ) | |
| (1,073,527 | ) |
| |
| | | |
| | |
Total | |
$ | - | | |
$ | - | |
Major
tax jurisdictions are the United States and California. All of the tax years will remain open three and four years for examination by
the Federal and state tax authorities, respectively, from the date of utilization of the net operating loss. There are no tax audits
pending.
NOTE
11 – EARNINGS PER SHARE
FASB
ASC Topic 260, Earnings Per Share, requires a reconciliation of the numerator and denominator of the basic and diluted earnings
(loss) per share (EPS) computations.
Basic
earnings (loss) per share are computed by dividing net earnings available to common stockholders by the weighted-average number of common
shares outstanding during the period. Diluted earnings (loss) per share is computed similar to basic earnings per share except that the
denominator is increased to include the number of additional common shares that would have been outstanding if the potential common shares
had been issued and if the additional common shares were dilutive. In periods where losses are reported, the weighted-average number
of common stock outstanding excludes common stock equivalents, because their inclusion would be anti-dilutive.
The
following potentially dilutive securities were excluded from the calculation of diluted net loss per share because the effects were anti-dilutive
based on the application of the treasury stock method and because the Company incurred net losses during the period:
SCHEDULE
OF ANTI DILUTIVE SECURITIES
| |
2022 | | |
2021 | |
| |
For the Years Ended December 31, | |
| |
2022 | | |
2021 | |
Convertible notes payable | |
| 11,726,940 | | |
| 5,489,940 | |
Warrants to purchase shares of common stock | |
| 15,192,493 | | |
| 7,992,558 | |
Total potentially dilutive shares | |
| 26,919,433 | | |
| 13,482,498 | |
The
following table sets forth the computation of basic and diluted net income per share:
SCHEDULE OF COMPUTATION OF BASIC AND DILUTED NET INCOME PER SHARE
| |
2022 | | |
2021 | |
| |
Years Ended December 31, | |
| |
2022 | | |
2021 | |
| |
| | |
| |
Net loss attributable to the common stockholders | |
$ | (2,929,817 | ) | |
$ | (3,004,619 | ) |
| |
| | | |
| | |
Basic weighted average outstanding shares of common stock | |
| 37,396,591 | | |
| 36,396,594 | |
Dilutive effect of options and warrants | |
| - | | |
| - | |
Diluted weighted average common stock and common stock equivalents | |
| 37,396,591 | | |
| 36,396,594 | |
| |
| | | |
| | |
Loss per share: | |
| | | |
| | |
Basic and diluted | |
$ | (0.08 | ) | |
$ | (0.08 | ) |
NOTE
12 – COMMITMENTS AND CONTINGENCIES
Legal
From
time to time, various lawsuits and legal proceedings may arise in the ordinary course of business. However, litigation is subject to
inherent uncertainties and an adverse result in these or other matters may arise from time to time that may harm our business. We are
currently not aware of any legal proceedings or claims that it believes will have a material adverse effect on its business, financial
condition or operating results.
Media
Advertising Agreement
On
May 13, 2021, the Company mutually terminated the Media Relations Agreement (“Media Agreement”) with a third party for marketing
and to promote brand awareness that was entered into on February 10, 2021. The Company agreed to pay $25,000 due in cash at the execution
of the Media Agreement. No shares were issued in conjunction with the Media Agreement.
Board
of Directors Compensation
Effective
October 10, 2022, the Company’s Board of Directors appointed Ms. Richa Nand, Mr. Jim Dorst, and Mr. Chris Wetzel as non-executive
members to the Company’s Board of Directors (“Director”). Each Director shall receive an annual retainer of $30,000
paid in equal quarterly amounts at the end of each quarter. In addition, each Director shall receive a grant of restricted stock units
of $50,000, or at the discretion of the Board of Directors, options to acquire shares of common stock. Restricted stock units will be
valued based on the average of the five trading days preceding and including the date of grant and will vest at a rate determined by
the Board of Directors over one year. If options are granted, the options will be valued at the exercise price based on the average of
the five trading days preceding and including the date of grant, have a ten year term, and will vest at a rate determined by the Board
of Directors.
NOTE
13 – SUBSEQUENT EVENTS
The
Company evaluated all events or transactions that occurred after December 31, 2022 up through the date the financial statements were
available to be issued. During this period, the Company did not have any material recognizable subsequent events required to be disclosed
as of and for the period ended December 31, 2022, except for the following:
Warrants
In
March 2023, the Company offered a short-term inducement to the Company’s warrant holders in which the Company will issue one share
of the Company’s common stock in exchange for each two warrants returned to the Company to be cancelled. All other terms of the
original grants remain the same. A total of 8,899,019 warrants were exchanged for 4,449,512 shares of the Company’s common stock
through March 24, 2023.
2023 Convertible Notes
During the three months ended March 31, 2023, the
Company entered into an Original Issue Discount Senior Convertible Debentures totaling (i) $970,200
aggregate principal amount of Note (total of $882,000 cash was received) due in various dates in January through March 2024 based on $1.00
for each $0.90909 paid by the previous noteholder and (ii) five-year Common Stock Purchase Warrants (“Warrants’) to purchase
up to an aggregate of 6,468,004 shares of the Company’s Common Stock at an exercise price of $0.25 per share. The
conversion price for the principal in connection with voluntary conversions by the holders of the convertible notes is $0.15 per share.