UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

FORM 10-Q

☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

For the quarterly period ended September 30, 2024

☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

For the transition period from __________ to _________

Commission File Number 000-55575

SIGYN THERAPEUTICS, INC.

(Exact name of registrant as specified in its charter)

Delaware		84-4210559
(State or other jurisdiction of incorporation)		(IRS Employer File Number)

2468 Historic Decatur Road Ste., 140, San Diego, California		92106
(Address of principal executive offices)		(zip code)

(619) 353-0800

(Registrant’s telephone number, including area code)

Securities registered pursuant to Section 12(b) of the Act:

Title of each class		Trading Symbol(s)		Name of each exchange on which registered
None

Securities registered pursuant to Section 12(g) of the Act:

Common Stock, $0.0001 Par Value

Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days. Yes ☒ No ☐

Indicate by checkmark whether the registrant has submitted electronically every Interactive Data File required to be submitted pursuant to rule 405 of Regulation S-T during the preceding 12 months (or for such shorter period that the registrant was required to submit such files). Yes ☒ No ☐

Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, or a smaller reporting company. See the definitions of “large accelerated filer,” “accelerated filer” and “smaller reporting company” in Rule 12b-2 of the Exchange Act.

Large accelerated filer	☐	Accelerated filer	☐
Non-accelerated filer	☒	Smaller reporting company	☒
		Emerging Growth Company	☐

If an emerging growth company, indicate by check mark if the Registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards pursuant to Section 13(a) of the Exchange Act. ☐

Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act). Yes ☐ No ☒

As of November 19, 2024, there were 1,605,378 shares of common stock outstanding.

SIGYN THERAPEUTICS, INC.

TABLE OF CONTENTS

Heading		Page

PART I – FINANCIAL INFORMATION

Item 1.	Financial Statements	4

	Unaudited Condensed Consolidated Balance Sheets as of September 30, 2024 and December 31, 2023	4

	Unaudited Condensed Consolidated Statements of Operations for the Three and Nine months ended September 30, 2024 and 2023	5

	Unaudited Condensed Consolidated Statements of Stockholders’ Deficit for the Three and Nine months ended September 30, 2024 and 2023	6

	Unaudited Condensed Consolidated Statements of Cash Flows for the Nine months ended September 30, 2024 and 2023	7

	Notes to the Unaudited Condensed Consolidated Financial Statements	8

Item 2.	Management’s Discussion and Analysis of Financial Condition and Results of Operations	24

Item 3.	Quantitative and Qualitative Disclosures About Market Risk	42

Item 4.	Controls and Procedures	42

PART II – OTHER INFORMATION

Item 1.	Legal Proceedings	43

Item1A.	Risk Factors	43

Item 2.	Unregistered Sales of Equity Securities and Use of Proceeds	44

Item 3.	Defaults Upon Senior Securities	44

Item 4.	Mine Safety Disclosure	44

Item 5.	Other Information	44

Item 6.	Exhibits	44

SIGNATURES		45

DISCLOSURE REGARDING FORWARD LOOKING STATEMENTS

This report contains forward-looking statements. The forward-looking statements are contained principally in the sections entitled “Description of Business,” “Risk Factors,” and “Management’s Discussion and Analysis of Financial Condition and Results of Operations.” These statements involve known and unknown risks, uncertainties and other factors which may cause our actual results, performance or achievements to be materially different from any future results, performances or achievements expressed or implied by the forward-looking statements. In some cases, you can identify forward-looking statements by terms such as “anticipates,” “believes,” “seeks,” “could,” “estimates,” “expects,” “intends,” “may,” “plans,” “potential,” “predicts,” “projects,” “should,” “would” and similar expressions intended to identify forward-looking statements. Forward-looking statements reflect our current views with respect to future events and are based on assumptions and subject to risks and uncertainties. The following factors, among others, could cause actual results to differ materially from those described in these forward-looking statements: the ability of Sigyn to meet its financial and strategic goals, due to, among other things, competition; the ability of Sigyn to grow and manage growth profitability and retain its key employees; the possibility that the Sigyn may be adversely affected by other economic, business, and/or competitive factors; risks relating to the successful development of Sigyn’s product candidates; the ability to successfully complete planned clinical studies of its product candidates; the risk that we may not fully enroll our clinical studies or enrollment will take longer than expected; risks relating to the occurrence of adverse safety events and/or unexpected concerns that may arise from data or analysis from our clinical studies; changes in applicable laws or regulations; expected initiation of the clinical studies, the timing of clinical data; the outcome of the clinical data, including whether the results of such study is positive or whether it can be replicated; the outcome of data collected, including whether the results of such data and/or correlation can be replicated; the timing, costs, conduct and outcome of our other clinical studies; the anticipated treatment of future clinical data by the FDA, the EMA or other regulatory authorities, including whether such data will be sufficient for approval; the success of future development activities for its product candidates; potential indications for which product candidates may be developed; the expected duration over which Sigyn’s balances will fund its operations; and other risks and uncertainties described herein, as well as those risks and uncertainties discussed from time to time in other reports and other public filings with the SEC by Sigyn.

Also, forward-looking statements represent our estimates and assumptions only as of the date of this report. You should read this report and the documents that we reference and filed as exhibits to this report completely and with the understanding that our actual future results may be materially different from what we expect. Except as required by law, we assume no obligation to update any forward-looking statements publicly, or to update the reasons actual results could differ materially from those anticipated in any forward-looking statements, even if new information becomes available in the future.

USE OF CERTAIN DEFINED TERMS

Except as otherwise indicated by the context, references in this report to “we,” “us,” “our,” “our Company,” or “the Company” is of Sigyn Therapeutics, Inc.

In addition, unless the context otherwise requires and for the purposes of this report only:

	●	“Sigyn” refers to Sigyn Therapeutics, Inc., a Delaware corporation;
	●	“Commission” refers to the Securities and Exchange Commission;
	●	“Exchange Act” refers to the Securities Exchange Act of 1934, as amended; and
	●	“Securities Act” refers to the Securities Act of 1933, as amended.

PART 1. FINANCIAL INFORMATION

ITEM 1. FINANCIAL STATEMENTS

SIGYN THERAPEUTICS, INC.

UNAUDITED CONDENSED CONSOLIDATED BALANCE SHEETS

	September 30,			December 31,
	2024			2023

ASSETS
Current assets:
Cash	$	164,788		$	11,690
Inventories		50,000			50,000
Other current assets		54,320			56,373
Total current assets		269,108			118,063

Property and equipment, net		11,048			15,296
Operating lease right-of-use assets, net		126,571			167,736
Other assets		20,711			20,711
Total assets	$	427,438		$	321,806

LIABILITIES AND STOCKHOLDERS’ DEFICIT
Current liabilities:
Accounts payable	$	611,643		$	461,646
Accrued payroll and payroll taxes		1,761,644			791,754
Advance from shareholder		43,426			80,000
Short-term convertible notes payable, less unamortized debt issuance costs of $204,723 and $297,337, respectively		1,790,865			2,210,299
Current portion of operating lease liabilities		67,650			61,123
Other current liabilities		48			3,182
Total current liabilities		4,275,276			3,608,004
Long-term liabilities:
Operating lease liabilities, net of current portion		74,748			126,302
Total long-term liabilities		74,748			126,302
Total liabilities		4,350,024			3,734,306

Stockholders’ deficit:
Preferred stock, $0.0001 par value, 10,000,000 shares authorized; 1,148 and 32 shares issued and outstanding at September 30, 2024 and December 31, 2023, respectively		-			-
Common stock, $0.0001 par value, 1,000,000,000 shares authorized; 1,420,678 and 1,288,415 shares issued and outstanding at September 30, 2024 and December 31, 2023, respectively		142			129
Additional paid-in capital		10,236,178			7,928,883
Accumulated deficit		(14,158,906	)		(11,341,512	)
Total stockholders’ deficit		(3,922,586	)		(3,412,500	)
Total liabilities and stockholders’ deficit	$	427,438		$	321,806

See accompanying notes to unaudited condensed consolidated financial statements.

SIGYN THERAPEUTICS, INC.

UNAUDITED CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS

	2024			2023			2024			2023
	Nine Months Ended September 30,						Three Months Ended September 30,
	2024			2023			2024			2023

Net revenues	$	-		$	-		$	-		$	-

Gross Profit		-			-			-			-

Operating expenses:
Marketing expenses		460			335			114			51
Stock based compensation		112,500			112,500			37,500			37,500
Research and development		679,183			582,232			206,161			215,230
General and administrative		1,249,089			1,043,014			564,683			390,033
Total operating expenses		2,041,232			1,738,081			808,458			642,814
Loss from operations		(2,041,232	)		(1,738,081	)		(808,458	)		(642,814	)

Other expense:
Modification of warrants		24,770			(226,929	)		24,770			(2,567	)
Interest expense		2,931			2,300			850			670
Interest expense - debt discount		423,663			1,309,703			263,719			220,854
Interest expense - original issuance costs		324,798			146,731			99,126			43,955
Total other expense		776,162			1,231,805			388,465			262,912

Loss before income taxes		(2,817,394	)		(2,969,886	)		(1,196,923	)		(905,726	)
Income taxes		-			-			-			-

Net loss	$	(2,817,394	)	$	(2,969,886	)	$	(1,196,923	)	$	(905,726	)

Net loss per share, basic and diluted	$	(2.26	)	$	(2.83	)	$	(0.94	)	$	(0.82	)

Weighted average number of shares outstanding
Basic and diluted		1,245,885			1,050,782			1,268,795			1,105,844

See accompanying notes to unaudited condensed consolidated financial statements.

SIGYN THERAPEUTICS, INC.

UNAUDITED CONDENSED CONSOLIDATED STATEMENTS OF STOCKHOLDERS’ DEFICIT

	Shares		Amount		Shares			Amount			in Capital			Deficit			Deficit
	Preferred Stock				Common Stock						Additional Paid			Accumulated			Total Stockholders’
	Shares		Amount		Shares			Amount			in Capital			Deficit			Deficit
Balance as of December 31, 2022		-	$	-		956,596		$	96		$	5,292,240		$	(7,195,576	)	$	(1,903,240	)
Warrants issued to third parties in conjunction with debt issuance		-		-		-			-			578,016			-			578,016
Beneficial conversion feature in conjunction with debt issuance		-		-		-			-			303,984			-			303,984
Stock based compensation		-		-		-			-			37,500			-			37,500
Modification of warrants		-		-		113,525			11			(15,817	)		-			(15,806	)
Fees associated with filing of Form S-1		-		-		-			-			(5,456	)		-			(5,456	)
Net loss		-		-		-			-			-			(1,341,036	)		(1,341,036	)
Balance as of March 31, 2023		-	$	-		1,070,121		$	107		$	6,190,467		$	(8,536,612	)	$	(2,346,038	)

Conversion of common stock for Series A preferred stock		30		-		(152,638	)		(15	)		15			-			-
Stock based compensation		-		-		-			-			37,500			-			37,500
Modification of warrants		-		-		157,228			16			(208,572	)		-			(208,556	)
Common stock issued to third parties in conjunction with conversion of debt		-		-		31,075			3			197,997			-			198,000
Net loss		-		-		-			-			-			(723,124	)		(723,124	)
Balance as of June 30, 2023		30	$	-		1,105,786		$	111		$	6,217,407		$	(9,259,736	)	$	(3,042,218	)

Warrants issued to third parties in conjunction with debt issuance		-		-		-			-			255,692			-			255,692
Beneficial conversion feature in conjunction with debt issuance		-		-		-			-			81,647			-			81,647
Conversion of common stock for Series A preferred stock		72		-		(9,045	)		(1	)		1			-			-
Stock based compensation		-		-		-			-			37,500			-			37,500
Modification of warrants		-		-		9,167			1			(2,567	)		-			(2,566	)
Net loss		-		-		-			-			-			(905,726	)		(905,726	)
Balance as of September 30, 2023		102	$	-		1,105,907		$	111		$	6,589,680		$	(10,165,462	)	$	(3,575,671	)

Balance as of December 31, 2023		32	$	-		1,288,415		$	129		$	7,928,883		$	(11,341,512	)	$	(3,412,500	)
Cancellation of common stock - related party		-		-		(64,100	)		(7	)		7			-			-
Post split rounding of shares		-		-		512			-			-			-			-
Stock based compensation		-		-		-			-			37,500			-			37,500
Warrants issued to third parties in conjunction with debt issuance		-		-		-			-			111,834			-			111,834
Net loss		-		-		-			-			-			(758,088	)		(758,088	)
Balance as of March 31, 2024		32	$	-		1,224,827		$	122		$	8,078,224		$	(12,099,600	)	$	(4,021,254	)

Common stock issued to third parties in conjunction with conversion of debt		-		-		38,826			4			232,933			-			232,937
Preferred stock issued to third parties in conjunction with conversion of debt		1,116		-		-			-			841,418			-			841,418
Stock based compensation		-		-		-			-			37,500			-			37,500
Warrants issued to third parties in conjunction with debt issuance		-		-		-			-			99,641			-			99,641
Net loss		-		-		-			-			-			(862,383	)		(862,383	)
Balance as of June 30, 2024		1,148	$	-		1,263,653		$	126		$	9,289,716		$	(12,961,983	)	$	(3,672,141	)
Balance		1,148	$	-		1,263,653		$	126		$	9,289,716		$	(12,961,983	)	$	(3,672,141	)

Warrants issued to third parties in conjunction with debt issuance		-		-		-			-			179,161			-			179,161
Common stock issued to third parties in conjunction with conversion of debt		-		-		118,700			12			474,782			-			474,794
Common stock issued to third party for services		-		-		38,325			4			214,546			-			214,550
Stock based compensation		-		-		-			-			37,500			-			37,500
Warrants issued to third parties for services		-		-		-			-			15,703			-			15,703
Modification of warrants		-		-		-			-			24,770			-			24,770
Net loss		-		-		-			-			-			(1,196,923	)		(1,196,923	)
Balance as of September 30, 2024		1,148	$	-		1,420,678		$	142		$	10,236,178		$	(14,158,906	)	$	(3,922,586	)
Balance		1,148	$	-		1,420,678		$	142		$	10,236,178		$	(14,158,906	)	$	(3,922,586	)

See accompanying notes to unaudited condensed consolidated financial statements.

SIGYN THERAPEUTICS, INC.

UNAUDITED CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS

	2024			2023
	Nine Months Ended September 30,
	2024			2023

Cash flows from operating activities:
Net loss	$	(2,817,394	)	$	(2,969,886	)
Adjustments to reconcile net loss to net cash used in operating activities:
Depreciation expense		4,248			5,146
Amortization expense		-			2,100
Stock issued for services		214,550			-
Warrants issued for services		15,703			-
Stock based compensation		112,500			112,500
Accretion of debt discount		423,663			1,309,703
Accretion of original issuance costs		324,798			146,731
Modification of warrants		24,770			(226,929	)
Changes in operating assets and liabilities:
Other current assets		2,053			(42,345	)
Accounts payable		149,997			34,112
Accrued payroll and payroll taxes		969,890			375,124
Other current liabilities		(6,996	)		(1,572	)
Net cash used in operating activities		(582,218	)		(1,255,316	)

Cash flows from financing activities:
Proceeds from short-term convertible notes		771,890			1,272,000
Advance from shareholder		35,000			45,000
Repayments of advance from shareholder		(71,574	)		-
Fees associated with filing of Form S-1		-			(5,456	)
Net cash provided by financing activities		735,316			1,311,544

Net (decrease) increase in cash		153,098			56,228

Cash at beginning of period		11,690			8,356
Cash at end of period	$	164,788		$	64,584

Supplemental disclosures of cash flow information:
Cash paid during the period for:
Interest	$	-		$	-
Income taxes	$	-		$	-

Non-cash investing and financing activities:
Warrants issued to third parties in conjunction with debt issuance	$	390,637		$	833,708
Original issue discount issued in conjunction with debt	$	80,739		$	127,200
Original issue discount issued in conjunction with extension of debt	$	184,471		$	305,319
Preferred stock issued to third parties in conjunction with conversion of debt	$	841,418		$	-
Common stock issued to third parties in conjunction with conversion of debt	$	707,730		$	198,000
Cancellation of common stock – related party	$	7		$	-
Beneficial conversion feature in conjunction with debt issuance	$	-		$	385,631
Conversion of common stock for Series A preferred stock	$	-		$	647

See accompanying notes to unaudited condensed consolidated financial statements.

SIGYN THERAPEUTICS, INC.

NOTES TO UNAUDITED CONDENSED CONSOLIDATED FINANCIAL STATEMENTS

NOTE 1 – ORGANIZATION AND PRINCIPAL ACTIVITIES

Corporate History and Background

Sigyn Therapeutics, Inc. (“Sigyn”, the “Company” “we,” “us,” or “our”) develops medical devices to treat cancer and infectious disease disorders. We believe our lineup of therapeutic candidates is among the most expansive in the field of extracorporeal blood purification. To optimize the benefit of drugs to treat cancer, we invented the ImmunePrep^TMplatform to enhance the performance of immunotherapeutic antibodies; ChemoPrep^TM to improve the delivery of chemotherapy; and ChemoPure^TM to reduce chemotherapy toxicity. Our lead therapeutic candidate is Sigyn Therapy^TM, which if successful, will address infectious disease disorders that are not treatable with drugs. If successfully advanced, our therapies may provide strategic value to the pharmaceutical, dialysis, and organ transplant industries.

Infectious Disease Disorders

To address infectious disease disorders that are not treatable with drugs, we designed Sigyn Therapy^TM to extract deadly pathogens and toxins from a patient’s bloodstream, while simultaneously providing a mechanism to dampen down excessive immune responses that are associated with life-threatening infections. Sigyn Therapy^TMhas been validated to extract viral pathogens, bacterial toxins (including endotoxin), hepatic toxins and inflammatory cytokines from human blood plasma. These expansive capabilities establish Sigyn Therapy^TMas a novel strategy to address several unmet needs in global health:

	1.	Untreatable viral pathogens (most of the 200+ viruses that infect humans are not treatable with drugs)

	2.	Antibiotic-resistant bacterial infections (an increasingly prevalent global health threat)

	3.	Endotoxemia (bacterial toxin whose bloodstream presence commonly induces sepsis)

	4.	Sepsis (leading cause of hospital deaths in the United States)

Previous Infectious Disease Industry Achievements

The Company’s management has relevant experience in developing blood purification technologies to treat infectious disease disorders. Most members of our team previously worked alongside our CEO while overseeing development of the first medical device to receive FDA “Emergency Use Authorization” approval to treat an infectious viral pathogen (Ebola) and the first to receive two “Breakthrough Device” designation awards from FDA. As a result of these achievements, in 2015, TIME Magazine named the device to its list of “Top Inventions” and “Top Medical Breakthroughs.”

Sigyn Therapy^TM Human Studies

First-in-human clinical studies of Sigyn Therapy^TM plan to enroll end-stage renal disease (ESRD) subjects with endotoxemia and concurrent inflammation, which are prevalent, yet untreatable conditions that shorten the lives of dialysis patients. Approximately 550,000 individuals suffer from ESRD in the United States. A therapeutic strategy that helps to extend the lives of ESRD patients may have quantifiable value to the dialysis industry, which is dominated by Fresenius Medical Care and DaVita, Inc. in North America. Based on the number of ESRD patients treated in their networks, every month of extended life would equate to approximately $1 billion in added revenues for each company.

Emerging Opportunity in Xenotransplantation

Beyond the post-exposure treatment of infectious disease disorders, Sigyn Therapy^TM offers a potential preventative strategy to reduce the spread of infection in organ transplantations, including xenotransplantation, an emerging field related to the transplantation of an organ from a donor animal species into a human recipient. The advancement of xenotransplantation is being fueled by a global shortage of transplantable human organs and the recent emergence of gene-editing technologies that have increased the compatibility of porcine-derived (pig) kidneys for human transplantation. In the United States, approximately 90,000 individuals are on the waitlist for a kidney transplant, yet fewer than 30,000 kidney transplants are performed each year.

To optimize xenotransplantation outcomes, Sigyn Therapy^TM is proposed for administration to:

Gene-edited donor pigs to reduce pathogen accumulation in donor kidneys prior to their extraction for human transplantation. The feasibility of Sigyn Therapy^TMadministration has been demonstrated in eight (8) porcine subjects to date.

Human transplant recipients during and after transplantation to reduce the bloodstream presence of pathogen, inflammatory and other circulating factors that may cause severe illness or induce the rejection of a transplanted organ, whose source may be either a human or animal donor.

This use of Sigyn Therapy^TMin these applications corresponds with published FDA guidance on the need for strategies to mitigate the risk of a known or unknown pathogen being transmitted from a porcine-derived organ to a human transplant recipient.

Devices to Optimize the Benefit of Cancer Therapies

We are not a developer of drugs to treat cancer. We are a developer of medical devices to optimize the benefit of drugs to treat cancer, the 2^nd leading cause of death in the United States. Our therapeutic candidates include the ImmunePrep^TM platform to enhance the performance of immunotherapeutic antibodies, ChemoPrep^TMto improve the delivery of chemotherapy, and ChemoPure^TMto extract off-target chemotherapy from the bloodstream to reduce treatment toxicity.

ImmunePrep^TMto Optimize Immunotherapeutic Antibodies

Immunotherapeutic antibodies (monoclonal antibodies, therapeutic antibodies, checkpoint inhibitors, antibody drug conjugates) generate more revenues than any other class of drug to treat cancer and are the most valued assets in global medicine based on 2023 and 2024 M&A transactions. However, therapeutic antibodies are poorly delivered to their intended cancer targets and as a result, most patients don’t respond to therapy. In many cases, less than 2% of an antibody dose will reach its cancer target, yet a significant portion of same dose can be intercepted by high concentrations of circulating decoys that display the antigen binding site of the antibody.

In response, we invented the ImmunePrep^TM platform to allow for a therapeutic antibody to be immobilized within an extracorporeal circuit to sweep antibody decoys out of the bloodstream prior to the subsequent infusion of the antibody to a patient. We believe this reverse decoy mechanism will improve targeted antibody delivery and simultaneously reduce the circulating presence of the antibody’s cancer targets to further enhance patient benefit. As a platform technology, ImmunePrep^TM allows for the potential development of products that may incorporate a development-stage, clinical-stage or market-approved antibody. Based on previous FDA interactions, we believe ImmunePrep^TMproducts that incorporate market-approved antibodies may have an accelerated pathway to potential market clearance.

ChemoPrep^TMto Optimize Chemotherapy Delivery

Chemotherapeutic agents are the most commonly administered class of drug to treat cancer, yet only a small fraction of infused doses reach their cancer cell targets. Contributing to inadequate delivery are high concentrations of tumor-derived exosomes, whose bloodstream presence disrupts chemotherapy delivery and corresponds with treatment resistance. We designed ChemoPrep^TM to reduce the circulating presence of tumor-derived exosomes prior chemotherapy administration. Our clinical goal is to maintain or improve the efficacy of chemotherapy with lower doses, which would reduce treatment toxicity. In this regard, ChemoPrep^TMaligns with the FDA “Project Optimus” initiative to minimize the toxicity of cancer drugs while maximizing patient benefit.

ChemoPure^TMto Reduce Chemotherapy Toxicity

Once chemotherapy has been administered, residual off-target chemotherapy that is left to circulate in the bloodstream is more likely to cause patient harm versus benefit. In response, we designed ChemoPure^TM to extract off-target chemotherapy from the bloodstream to further reduce treatment toxicity.

To learn more, visit: www.SigynTherapeutics.com.

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”).

Reverse Stock Split

Effective January 19, 2024, Board of Directors declared a one-for-forty reverse stock split to shareholders of record on or before January 31, 2024 of the Company’s issued and outstanding shares of common stock, outstanding warrants and options, and the Series B Convertible Preferred Stock. The number of shares of common stock and convertible preferred shares obtainable upon exercise or conversion and the exercise prices and conversion rate have been equitably adjusted. As such, all share and per share amounts have been retroactively adjusted to reflect the reverse stock split.

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 $14,158,906 at September 30, 2024, had a working capital deficit of $4,006,168 at September 30, 2024, had net losses of $1,196,923 and $2,817,394, and $905,726 and $2,969,886 for the three and nine months ended September 30, 2024 and 2023, respectively, and net cash used in operating activities of $582,218 and $1,255,316 for the nine months ended September 30, 2024 and 2023, 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 generate revenues, the Company’s cash position will not be significant enough to support the Company’s daily operations for the foreseeable future. Management intends to raise additional funds by way of a private offering, 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 for a year from the date of issuance.

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: warrant valuation. The Company calculates the fair value of warrants using the Black-Scholes option-pricing method. The Black-Scholes option-pricing method requires the use of subjective assumptions, including stock price volatility, the expected life of stock options, risk free interest rate and the fair value of the underlying common stock on the date of grant. 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 unaudited condensed 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 or any uncertain income tax positions.

Advertising and Marketing Costs

Advertising expenses are recorded as general and administrative expenses when they are incurred. The Company had $114 and $460, and $51 and $335 of advertising expenses for the three and nine months ended September 30, 2024 and 2023, respectively.

Research and Development

All research and development costs are expensed as incurred. The Company incurred research and development expense of $206,161 and $679,183, and $215,230 and $582,232 for the three and nine months ended September 30, 2024 and 2023, 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 September 30, 2024 and December 31, 2023, the Company carried primarily loose sapphire jewels, jewelry for sale, 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 September 30, 2024. 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.

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.

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 September 30, 2024 and December 31, 2023, 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 September 30, 2024 and December 31, 2023, the fair value of cash, accounts payable, accrued expenses, advance from shareholder, 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 its 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 September 30, 2024 and December 31, 2023 and no charges or credits to income for the three and nine months ended September 30, 2024 and 2023.

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 unaudited condensed 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 unaudited condensed consolidated balance sheets.

If the conversion feature does not qualify for either the derivative treatment or as a beneficial conversion feature, 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 718, 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 unaudited condensed consolidated statements 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.

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^TM 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^TM 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^TM.

Recent Accounting Pronouncements

There are no recently issued accounting updates that are 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

		September 30,			December 31,
	Estimated Life	2024			2023

Office equipment	5 years	$	29,041		$	29,041
Computer equipment	3 years		3,157			3,157
Property and equipment, gross	3 years		3,157			3,157
Accumulated depreciation			(21,150	)		(16,902	)
Property and equipment, net		$	11,048		$	15,296

Depreciation expense was $1,363 and $4,248, and $1,716 and $5,146 for the three and nine months ended September 30, 2024 and 2023, respectively, and is classified in general and administrative expenses in the unaudited condensed consolidated statements of operations.

NOTE 5 – CONVERTIBLE PROMISSORY DEBENTURES

Convertible notes payable consisted of the following:

SCHEDULE OF CONVERTIBLE NOTES PAYABLE

Note Holder/Original Issuance Date	Maturity Date	Cash Received		Outstanding Balance as of September 30, 2024			Outstanding Balance as of December 31, 2023
Osher Capital Partners LLC
January 28, 2020 (“Note 1”)	August 31, 2025	$	350,005	$	620,553		$	564,138
June 22, 2022 (“Note 2”)	August 31, 2025		75,000		103,745			94,314
August 31, 2022 (“Note 2”)	August 31, 2025		100,000		135,520			123,200
September 20, 2022 (“Note 2”)	August 31, 2025		100,000		135,520			123,200
October 20, 2022 (“Note 2”)	March 31, 2025		100,000		127,000			110,000
November 14, 2022 (“Note 2”)	March 31, 2025		50,000		64,350			55,000
December 22, 2022 (“Note 2”)	March 31, 2025		100,000		125,000			110,000
July 18, 2023 (“Note 3”)	August 31, 2025		60,000		72,600			66,000
December 7, 2023 (“Note 3”)	August 31, 2025		40,000		48,400			44,000
May 13, 2024 (“Note 4”)	May 13, 2025		35,000		40,000			-
August 19, 2024 (“Note 4”)	August 19, 2025		7,500		8,250			-

Brio Capital Master Fund, Ltd.
March 23, 2022 (“Note 2”)	August 31, 2025		100,000		142,960			129,964
November 9, 2022 (“Note 2”)	August 31, 2025		75,000		101,640			92,400
January 20, 2023 (“Note 3”)	March 31, 2025		50,000		62,500			55,000
February 9, 2023 (“Note 3”)	March 31, 2025		50,000		62,500			55,000
July 20, 2023 (“Note 3”)	August 31, 2025		40,000		48,400			44,000
January 8, 2024 (“Note 4”)	January 8, 2025		40,000		44,000			-
May 13, 2024 (“Note 4”)	May 13, 2025		35,000		40,000			-
August 20, 2024 (“Note 4”)	August 20, 2025		11,500		12,650			-

Various third-party noteholders
Various dates in fiscal 2024 (“Note 4”)	None outstanding		642,890		-			-

Previous fiscal 2021, 2022, and 2023 Osher and Brio Notes converted in fiscal 2024					-			841,420
Total convertible notes payable		$	2,061,895	$	1,995,588		$	2,507,636
Original issue discount					(166,247	)		(225,835	)
Beneficial conversion feature					-			(22,013	)
Debt discount					(38,476	)		(49,489	)

Total convertible notes payable				$	1,790,865		$	2,210,299

Principal payments on convertible promissory debentures are due as follows:

Year ending December 31,
2025	$	1,995,588
Long-Term Debt	$	1,995,588

Changes in convertible notes were as follows:

	Note 1			Note 2			Note 3			Note 4			Totals
Convertible notes payable as of December 31, 2022	$	700,816		$	1,578,500		$	-		$	-		$	2,279,316

Convertible notes payable issued in 2023		163,320			142,000			1,443,200			-			1,748,520
Conversion of debt for common stock		-			(341,000	)		(1,179,200	)		-			(1,520,200	)
Convertible notes payable as of December 31, 2023	$	864,136		$	1,379,500		$	264,000		$	-		$	2,507,636
Convertible notes payable as of beginning balance	$	864,136		$	1,379,500		$	264,000		$	-		$	2,507,636

Convertible notes payable issued in 2024		56,416			97,655			30,400			852,630			1,037,101
Convertible notes payable issued		56,416			97,655			30,400			852,630			1,037,101
Conversion of debt for common stock		(299,999	)		(541,420	)		-			(707,730	)		(1,549,149	)
Convertible notes payable as of September 30, 2024	$	620,553		$	935,735		$	294,400		$	144,900		$	1,995,588
Convertible notes payable as of ending balance	$	620,553		$	935,735		$	294,400		$	144,900		$	1,995,588

Changes in note discounts were as follows:

SCHEDULE OF CHANGES IN NOTE DISCOUNTS

	Note 1			Note 2			Note 3			Note 4			Totals
Note discounts as of December 31, 2022	$	-		$	642,660		$	-		$	-		$	642,660

Note discounts issued in conjunction with debt in 2023		163,320			142,000			1,390,535			-			1,695,855
2023 accretion of note discounts		(48,325	)		(683,850	)		(1,309,003	)		-			(2,041,178	)
Note discounts as of December 31, 2023	$	114,995		$	100,810		$	81,532		$	-		$	297,337
Note discounts as of beginning balance	$	114,995		$	100,810		$	81,532		$	-		$	297,337

Note discounts issued in conjunction with debt in 2024		56,414			97,657			30,400			470,826			665,297
Note discounts issued in conjunction with debt		56,414			97,657			30,400			470,826			665,297
2024 accretion of note discounts		(114,995	)		(116,489	)		(88,501	)		(427,926	)		(747,911	)
Accretion of note discounts		(114,995	)		(116,489	)		(88,501	)		(427,926	)		(747,911	)
Note discounts as of September 30, 2024	$	56,414		$	81,978		$	23,431		$	42,900		$	204,723
Note discounts as of ending balance	$	56,414		$	81,978		$	23,431		$	42,900		$	204,723

Convertible notes payable, net, as of December 31, 2023	$	749,141		$	1,278,690		$	182,468		$	-		$	2,210,299
Convertible notes payable, net, as of September 30, 2024	$	564,139		$	853,757		$	270,969		$	102,000		$	1,790,865
Convertible notes payable, net	$	564,139		$	853,757		$	270,969		$	102,000		$	1,790,865

2023 Effective interest rate		6	%		50	%		496	%		-	%		81	%
2024 Effective interest rate		19	%		12	%		30	%		295	%		37	%

Current Noteholders

2024 Convertible Notes (Note 4)

During fiscal 2024, the Company entered into Original Issue Discount Senior Convertible Debentures (the “2024 Notes”) totaling (i) $852,630 aggregate principal amount of Notes (total of $771,890 cash was received) due between January and June 2025 based on $1.00 for each $0.90909 paid by the noteholders and (ii) five-year Common Stock Purchase Warrants (“Warrants”) to purchase up to an aggregate of 213,164 shares of the Company’s Common Stock at an exercise price of $7.50 per share. The aggregate cash subscription amount received by the Company for the issuance of the Note and Warrants was $771,891 which was issued at a $80,739 original issue discount from the face value of the Note.

In September 2024, holders converted $474,794 in exchange for the issuance of 118,700 shares of Common Stock to the holders.

In May 2024, holders converted $232,937 in exchange for the issuance of 38,826 shares of Common Stock to the holders.

2023 Convertible Notes (Note 3)

During fiscal 2023, the Company entered into Original Issue Discount Senior Convertible Debentures (the “2023 Notes”) totaling (i) $264,000 aggregate principal amount of Notes (total of $240,000 cash was received) due in various dates from July 2024 through March 2025 based on $1.00 for each $0.90909 paid by the noteholders and (ii) five-year Common Stock Purchase Warrants (“Warrants”) to purchase up to an aggregate of 44,002 shares of the Company’s Common Stock at an exercise price of $7.50 per share. The aggregate cash subscription amount received by the Company for the issuance of the Note and Warrants was $240,000 which was issued at a $24,000 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 $4.00 per share, subject to adjustment as provided therein, such as stock splits and stock dividends.

On September 30, 2024, a noteholder agreed to extend the note to August 31, 2025 for original issue discount totaling $15,400.

On April 9, 2024, a noteholder agreed to extend the note to March 31, 2025 for original issue discount totaling $15,000.

2022 Convertible Notes (Note 2)

During fiscal 2022, the Company entered into Original Issue Discount Senior Convertible Debentures (the “2022 Notes”) totaling (i) $879,428 aggregate principal amount of Notes (total of $700,000 cash was received) due on various dates from January 2024 through December 7, 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 240,534 shares of the Company’s Common Stock at an exercise price of $7.50 per share. The aggregate cash subscription amount received by the Company from the previous noteholder for the issuance of the Note and Warrants was $770,000 which was issued at a $70,000 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 $4.00 per share, subject to adjustment as provided therein, such as stock splits and stock dividends.

On September 30, 2024, a noteholder agreed to extend the note to August 31, 2025 for original issue discount totaling $56,306.

On April 10, 2024, a noteholder agreed to extend the notes to between August 2024 and March 2025 for original issue discount totaling $41,350.

Osher – $564,139 (Note 1)

On January 28, 2020, as subsequently amended, 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) $564,139 aggregate principal amount of Original Issue Discount Senior Convertible Debenture due August 30, 2024, 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 102,827 shares of the Company’s Common Stock at an exercise price of $5.60 per share. The aggregate cash subscription amount received by the Company from Osher for the issuance of the note and warrants was $350,005 with a total of $214,133 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 $3.76 per share, subject to adjustment as provided therein, such as stock splits and stock dividends.

On September 30, 2024, a noteholder agreed to extend the note to August 31, 2025 for original issue discount totaling $56,414.

NOTE 6 – ADVANCE FROM SHAREHOLDER

The Company borrows funds from the Company’s CEO for working capital purposes from time to time. The Company has recorded the principal balance due of $43,426 and $80,000 under Advance from Shareholder in the accompanying the unaudited condensed consolidated balance sheets at September 30, 2024 and December 31, 2023, respectively. The Company received advances of $35,000 and $64,500 and had repayments of $71,574 and $19,500 for the nine months ended September 30, 2024 and 2023. The advances from our CEO were not made pursuant to any loan agreements or promissory notes, are non-interest bearing and due on demand.

NOTE 7 – STOCKHOLDERS’ DEFICIT

Preferred Stock

The Company authorized 10,000,000 shares of par value $0.0001 preferred stock, of which 1,148 and 32 shares are issued and outstanding as of September 30, 2024 and December 31, 2023, respectively.

On April 10, 2024, Osher elected to exchange $621,000 of Notes for an aggregate of 823.86 shares of Series B Convertible Preferred Stock. Each Series B Convertible Preferred Share converts into 125.63 shares of the Company’s common stock, subject to antidilution adjustments for any stock splits and recapitalizations, and for issuances of additional shares at an issue price of less than the conversion ratio.

On April 9, 2024, Brio elected to exchange $220,420 of Notes for an aggregate of 292.4 shares of Series B Convertible Preferred Stock. Each Series B Convertible Preferred Share converts into 125.63 shares of the Company’s common stock, subject to antidilution adjustments for any stock splits and recapitalizations, and for issuances of additional shares at an issue price of less than the conversion ratio.

During fiscal 2023, holders of 161,684 shares of common stock elected to exchange these shares for an aggregate of 32 shares of Series B Convertible Preferred Stock. Each Series B Convertible Preferred Share converts into 126.63 shares of the Company’s common stock, subject to antidilution adjustments for any stock splits and recapitalizations, and for issuances of additional shares at an issue price of less than the conversion ratio in the Warrant Exchange Agreement.

Rights and Privileges - The holders of Series B preferred stock have various rights and preferences as follows:

Rights - The holders of the Series B preferred stock have the same rights as the Common Stock, on an “as-if” converted basis, with respect to any dividends, distribution of assets of the Company, including upon a liquidation, bankruptcy, reorganization, merger, acquisition, sale, dissolution or winding up of the Company, whether voluntarily or involuntarily.

Voting Rights - Shares of Series B preferred stock have no voting rights except on matters adversely affecting the rights of the holders of the Preferred Stock.

Rank - With respect to payment of dividends and distribution of assets upon liquidation or dissolution or winding up of the Corporation, whether voluntary or involuntary, the Series B Preferred Stock shall rank equal to the Common Stock on an as converted basis.

Conversion Rights - The holders of the preferred stock have certain conversion rights of such preferred stock into shares of common stock of the Company. Each share of preferred stock is convertible at the option of the holder at any time into the number of shares of common stock at the quotient of the stated value divided by the conversion price, subject to customary adjustments to protect against dilution.

Redemption Rights – The Series B preferred stock is not subject to any redemption rights.

Common Stock

The Company has authorized 1,000,000,000 shares of par value $0.0001 common stock, of which 1,420,678 and 1,288,415 shares are outstanding as of September 30, 2024 and December 31, 2023, respectively.

In the nine months ended September 30, 2024, the holders of $707,730 of Original Issue Discount Senior Convertible Debentures converted their debentures in exchange for the issuance of 157,526 shares of Common Stock to the holders.

During the nine months ended September 30, 2024, the Company issued 38,325 common shares valued at $214,550 (based on the estimated fair value of the stock on the date of grant), respectively, for services rendered.

During the year ended December 31, 2023, a total of 559,839 warrants were exchanged for 279,920 shares of the Company’s common stock.

On June 2, 2023, a third-party investor elected to convert the aggregate principal amount of two Notes of $198,000, into 31,075 common shares.

Shares Cancelled

On January 9, 2024, the Company’s CTO agreed to surrender 64,100 common shares held by him and were cancelled by the Company.

Restricted Stock Units

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”). Effective January 1, 2023, each Director began receiving an annual grant of restricted stock units of $50,000. During the three and nine months ended September 30, 2024 and 2023, respectively, the Company recorded stock-based compensation totaling $37,500 and $112,500, and $37,500 and $112,500, respectively, in the unaudited condensed consolidated statements of operations.

Reverse Stock Split

Warrants

On August 24, 2024, the Company issued 3,325 warrants valued at $15,703 (based on the fair value of the options using the Black-Scholes option-pricing method on the date of grant), for services rendered.

In accordance with ASC 718-20, Compensation – Stock Compensation, a modification of a stock award is treated as an exchange of the original award for a new award incurring additional compensation cost for any incremental value resulting from the modification. Incremental compensation cost shall be measured as the excess of the fair value of the modified award over the fair value of the original award immediately before its terms are modified and recognized over the vesting period. A short-term inducement shall be accounted for as a modification of the terms of only those that accept the inducement.

On September 5, 2024, the Company entered into the 2024 Notes that included warrants at an exercise price of $7.50 (see Note 5) resulting in a modification of the warrants valued at $24,770 (based on the Black Scholes options pricing method on the modification date).

In March 2023, the Company offered a short-term inducement to the Company’s third party warrant holders in which the Company will issue one share of the Company’s common stock in exchange for each two warrants were exchanged for 279,920 shares of the Company’s common stock through December 31, 2023. The Company recognized a gain of $352,965 due to the modification of the warrants in the year ended December 31, 2023, as a result of the modification.

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 and ending on 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:


	Nine Months ended September 30,				Three Months ended September 30,
	2024		2023		2024		2023
Operating lease expense	$	53,757	$	53,757	$	17,919	$	17,919
Short term lease cost	$	-	$	-	$	-	$	-
Total lease expense	$	53,757	$	53,757	$	17,919	$	17,919

In accordance with ASC 842, other information related to leases was as follows:

*Nine Months ended September 30,*	2024			2023
Operating cash flows from operating leases	$	57,619		$	55,941
Cash paid for amounts included in the measurement of lease liabilities	$	57,619		$	55,941

Weighted-average remaining lease term—operating leases		1.92 years			2.92 years
Weighted-average discount rate—operating leases		10	%		10	%

In accordance with ASC 842, maturities of operating lease liabilities as of September 30, 2024 were as follows:

	Operating
Year ending:	Lease
2024 (remaining 3 months)	$	19,522
2025		79,456
2026		54,225
Total undiscounted cash flows	$	153,203

Reconciliation of lease liabilities:
Weighted-average remaining lease terms		1.92 years
Weighted-average discount rate		10	%
Present values	$	142,398

Lease liabilities—current		67,650
Lease liabilities—long-term		74,748
Lease liabilities—total	$	142,398

Difference between undiscounted and discounted cash flows	$	10,805

NOTE 9 – RELATED PARTY TRANSACTIONS

Other than as set forth below, and as disclosed in Notes 6 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 $113,750 (including accrued compensation of $113,750) and $341,250 (including accrued compensation of $341,250), and $113,750 (including accrued compensation of $113,750) and $345,585 (including accrued compensation of $174,960) for the three and nine months ended September 30, 2024 and 2023, respectively.

Mr. DeCiccio was hired December 6, 2023 as the Company’s Chief Financial Officer (“CFO”). Mr. DeCiccio receives an annual base salary of $250,000, plus discretionary bonus compensation not to exceed 40% of salary. Mr. DeCiccio’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. DeCiccio was granted stock options to purchase 17,500 shares of the Company’s common shares. The Company incurred compensation expense of $31,248 (including accrued compensation of $31,248) and $93,744 (including accrued compensation of $93,744) for the three and nine months ended September 30, 2024, respectively. Prior to Mr. DeCiccio being hired as the CFO, he was a consultant to the Company. The Company has recorded a balance due to Mr. DeCiccio of $21,575 and $35,242 under Accounts Payable in the accompanying the condensed consolidated balance sheets as of September 30, 2024 (unaudited) and December 31, 2023, respectively, for services rendered.

On April 1, 2023, the Company entered into an Employment Agreement with Dr. Annette Marleau whereby Dr. Marleau became the Company’s Chief Scientific Officer. Dr. Marleau receives an annual base salary of $300,000, with automatic 3% annual increases plus bonus compensation not to exceed 40% of salary. Dr. Marleau’s employment also provides for medical insurance, disability benefits and up to six months of severance pay if her employment is terminated by the Company. The Company incurred compensation expense of $77,250 (including accrued compensation of $64,375) and $231,750 (including accrued compensation of $193,125), and $75,000 (including accrued compensation of $37,500) and $151,610 (including accrued compensation of $37,500) for the three and nine months ended September 30, 2024 and 2023, respectively.

NOTE 10 – 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


	For the Nine Months Ended September 30,				For the Three Months Ended September 30,
	2024		2023		2024		2023
Convertible notes payable		509,504		546,185		509,504		546,185
Restricted stock units		41,566		12,885		12,424		4,295
Warrants to purchase shares of common stock		251,125		53,167		251,125		53,167
Total potentially dilutive shares		802,195		612,237		773,053		603,647

The following table sets forth the computation of basic and diluted net income per share:


	Nine Months Ended September 30,						Three Months Ended September 30,
	2024			2023			2024			2023

Net loss attributable to the common stockholders	$	(2,817,394	)	$	(2,969,886	)	$	(1,196,923	)	$	(905,726	)

Basic weighted average outstanding shares of common stock		1,245,885			1,050,782			1,268,795			1,105,844
Dilutive effect of options and warrants		-			-			-			-
Diluted weighted average common stock and common stock equivalents		1,245,885			1,050,782			1,268,795			1,105,844

Loss per share:
Basic and diluted	$	(2.26	)	$	(2.83	)	$	(0.94	)	$	(0.82	)

NOTE 11 – 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.

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 12 – SUBSEQUENT EVENTS

The Company evaluated all events or transactions that occurred after September 30, 2024 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 September 30, 2024, except for the following:

Warrants

On October 8, 2024, the Company offered a short-term inducement to the Company’s warrant holders in which the Company will issue ¾ of a share of the Company’s common stock in exchange for each warrant. In response to this offer, 246,257 warrants were exchanged for 184,700 shares of the Company’s common stock. The Company recognized a loss of $29,971 due to the modification of the warrants in October 2024.

ITEM 2. MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS

You should read the following discussion of our financial condition and results of operations in conjunction with our financial statements and the notes included elsewhere in this Form 10-Q. The following discussion contains forward-looking statements that involve certain risks and uncertainties. Our actual results could differ materially from those discussed in these statements. Factors that could cause or contribute to these differences include those discussed below and elsewhere in this Form 10-Q and our Annual Report on Form 10-K for the year ended December 31, 2023 particularly under the “Risk Factors” and “Cautionary Note Regarding Forward-Looking Statements and Risk Factors Summary” sections.

Recent Developments

Reverse Stock Split

Financing Transactions

Preferred Stock

The Company has 10,000,000 shares of par value $0.0001 preferred stock authorized, of which 1,148 and 32 shares preferred shares are issued and outstanding as of September 30, 2024 and December, 31, 2023, respectively.

Common Stock

The Company has authorized 1,000,000,000 shares of par value $0.0001 common stock, of which 1,420,678 and 1,288,415 shares were outstanding as of September 30, 2024 and December 31, 2023, respectively.

During the year ended December 31, 2023, a total of 559,839 warrants were exchanged for 279,920 shares of the Company’s common stock.

On June 2, 2023, a third-party investor elected to convert the aggregate principal amount of two Notes of $198,000, into 31,075 common shares.

Shares Cancelled

On January 9, 2024, the Company’s CTO agreed to surrender 64,100 common shares held by him and were cancelled by the Company.

Restricted Stock Units

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”). Effective January 1, 2023, each Director receives an annual grant of restricted stock units of $50,000. During the three and nine months ended September 30, 2024 and 2023, respectively, the Company recorded stock-based compensation totaling $37,500 and $112,500, and $37,500 and $112,500, respectively, in the unaudited condensed consolidated statements of operations.

Warrants

On October 8, 2024, the Company offered a short-term inducement to the Company’s warrant holders in which the Company will issue ¾ of a share of the Company’s common stock in exchange for each warrant. In response to this offer 246,257 warrants were exchanged for 184,700 shares of the Company’s common stock. The Company recognized a loss of $29,971 due to the modification of the warrants in October 2024.

Current Noteholders

2024 Convertible Notes

During fiscal 2024, the Company entered into Original Issue Discount Senior Convertible Debentures (the “2024 Notes”) totaling (i) $852,630 aggregate principal amount of Notes (total of $771,891 cash was received) due between January and June 2025 based on $1.00 for each $0.90909 paid by the noteholders and (ii) five-year Common Stock Purchase Warrants (“Warrants”) to purchase up to an aggregate of 213,164 shares of the Company’s Common Stock at an exercise price of $7.50 per share. The aggregate cash subscription amount received by the Company for the issuance of the Note and Warrants was $771,891 which was issued at a $80,738 original issue discount from the face value of the Note. In connection with voluntary conversions by the holders of the convertible notes, the conversion price for principal of $619,692 is $4.00 per share and principal of $232,937 is $6.00 per share, subject to adjustment as provided therein, such as stock splits and stock dividends.

In September 2024, holders converted $474,793 in exchange for the issuance of 118,700 shares of Common Stock to the holders.

In May 2024, holders converted $232,937 in exchange for the issuance of 38,826 shares of Common Stock to the holders.

2023 Convertible Notes

On September 30, 2024, a noteholder agreed to extend the note to August 31, 2025 for original issue discount totaling $15,400.

On April 9, 2024, a noteholder agreed to extend the note to March 31, 2025 for original issue discount totaling $15,000.

2022 Convertible Notes

During fiscal 2022, the Company entered into Original Issue Discount Senior Convertible Debentures (the “2022 Notes”) totaling (i) $879,428 aggregate principal amount of Notes (total of $700,000 cash was received) due on various dates from January 2024 through December 7, 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 240,534 shares of the Company’s Common Stock at an exercise price of $10.00 per share. The aggregate cash subscription amount received by the Company from the previous noteholder for the issuance of the Note and Warrants was $770,000 which was issued at a $70,000 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 $6.00 per share, subject to adjustment as provided therein, such as stock splits and stock dividends.

On September 30, 2024, a noteholder agreed to extend the note to August 31, 2025 for original issue discount totaling $56,306.

On April 10, 2024, a noteholder agreed to extend the notes to between August 2024 and March 2025 for original issue discount totaling $41,350.

Osher – $564,139

On September 30, 2024, a noteholder agreed to extend the note to August 31, 2025 for original issue discount totaling $56,414.

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.

Business Overview

Sigyn Therapeutics, Inc. (“Sigyn”, the “Company” “we,” “us,” or “our”) develops medical devices to treat cancer and infectious disease disorders. We believe our lineup of therapeutic candidates is among the most expansive in the field of extracorporeal blood purification. To optimize the benefit of drugs to treat cancer, we invented the ImmunePrep^TMplatform to enhance the performance of immunotherapeutic antibodies; ChemoPrep^TM to improve the delivery of chemotherapy; and ChemoPure^TM to reduce chemotherapy toxicity. Our lead therapeutic candidate is Sigyn Therapy^TMdesigned to address infectious disease disorders that are not treatable with drugs. If successfully advanced, our therapies may provide strategic value to the pharmaceutical, dialysis, and organ transplant industry.

Infectious Disease Disorders

Untreatable viral pathogens (most of the 200+ viruses that infect humans are not treatable with drugs)

Antibiotic-resistant bacterial infections (an increasingly prevalent global health threat)

Endotoxemia (bacterial toxin whose bloodstream presence commonly induces sepsis)

Sepsis (leading cause of hospital deaths in the United States)

Previous Infectious Disease Industry Achievements

The Company’s management has relevant experience in developing blood purification technologies to treat infectious disease disorders. Most members of our team previously worked alongside our CEO while overseeing development of the first medical device to receive FDA “Emergency Use Authorization” approval to treat an infectious viral pathogen (Ebola) and the first to receive two “Breakthrough Device” designation awards from FDA. As a result of these achievements, TIME Magazine named the device to its list of “Top Inventions” and “Top Medical Breakthroughs.”

Sigyn Therapy^TM Human Studies

Emerging Opportunity in Xenotransplantation

To optimize xenotransplantation outcomes, Sigyn Therapy^TM is proposed for administration to:

Devices to Optimize the Benefit of Cancer Therapies

ImmunePrep^TMto Optimize Immunotherapeutic Antibodies

Immunotherapeutic antibodies (monoclonal antibodies, therapeutic antibodies, checkpoint inhibitors, antibody drug conjugates) generate more revenues than any other class of drug to treat cancer and are the most valued assets in global medicine based on 2023 and 2024 M&A transactions. However, therapeutic antibodies are poorly delivered to their intended cancer targets and, as a result, most patients don’t respond to therapy. In many cases, less than 2% of an antibody dose will reach its cancer target, yet a significant portion of same dose can be intercepted by high concentrations of circulating decoys that display the antigen binding site of the antibody.

ChemoPrep^TMto Optimize Chemotherapy Delivery

ChemoPure^TMto Reduce Chemotherapy Toxicity

About Sigyn Therapy^TM - Our Lead Therapeutic Candidate

Sigyn Therapy^TMPre-Clinical Studies

Since the inception of our Company, we have advanced Sigyn Therapy^TM from conceptual design through completion of pre-clinical in vitro studies that have quantified the reduction of relevant therapeutic targets from human blood plasma with small-scale versions of Sigyn Therapy^TM. 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 tumor 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.

Sigyn Therapy^TMAnimal Studies

Subsequent to our pre-clinical in vitro studies, we disclosed the completion of in vivo animal studies. In these studies, Sigyn Therapy^TMwas administered via standard dialysis machines utilizing conventional blood-tubing sets, for periods of up to six hours to 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^TM; 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 underlie 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.

Sigyn Therapy^TMClinical Plan

The data resulting from our in vivo animal and pre-clinical in vitro studies has been incorporated in an Investigational Device Exemption (IDE) that we have drafted for submission to the U.S. Food and Drug Administration (“FDA”) to support first-in-human feasibility studies of Sigyn Therapy^TM. The clinical plan of our IDE proposes to enroll 12-15 End-Stage Renal Disease (“ESRD”) patients with endotoxemia and concurrent inflammation at three clinical site locations that have been identified and evaluated by a contract research organization that specializes in ESRD related clinical studies. The primary study objective is to demonstrate that Sigyn Therapy^TMcan be safely administered to health compromised ESRD subjects. Additionally, we plan to quantify changes in endotoxin levels as well as markers of inflammation as secondary endpoints. The clinical plan proposed in our draft IDE has not yet been provided to FDA and there is no assurance that FDA will approve the initiation of our proposed feasibility study, nor is there any assurance that we will receive FDA market approval of Sigyn Therapy^TM.

Based on our previous experience in developing extracorporeal blood purification therapies, we believe we have collected sufficient data to support first-in-human studies of Sigyn Therapy^TM. However, Sigyn Therapy^TM is a Class III device that requires extensive pre-clinical and clinical studies to be conducted along with the submission of a Pre-Market Approval (PMA) application prior to market clearance consideration by FDA.

Sigyn Therapy^TM Mechanism of Action

We designed Sigyn Therapy^TM to treat life-threatening infectious disease disorders that are not addressed with drug therapies. Based on its ability to extract viral pathogens, bacterial toxins (including endotoxin), hepatic toxins and inflammatory cytokines from human blood plasma, Sigyn Therapy^TMestablishes a novel strategy to address several unmet needs in global health. These include untreatable viral pathogens, antibiotic resistant bacterial infections, endotoxemia, and sepsis.

To support widespread implementation, Sigyn Therapy^TM 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^TM was deployed for use on a dialysis machine manufactured by Fresenius Medical Care, a global leader in the dialysis industry.

Incorporated within Sigyn Therapy^TM 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^TM is not constrained by such limitations as active adsorbent components are maintained within Sigyn Therapy^TMand 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^TM. Each adsorbent component has differing capture characteristics that contribute to optimizing the potential of Sigyn Therapy^TM to reduce the circulating presence of both pathogen and inflammatory targets that underly sepsis and other life-threatening infectious disease disorders.

The adsorbent components incorporated within Sigyn Therapy^TM provide more than 200,000 square meters (~50 acres) of surface area on which to adsorb and remove therapeutic targets from the bloodstream. Beyond its capacity to reduce the circulating presence of therapeutic targets we believe Sigyn Therapy^TM to be a highly efficient treatment methodology. Based on targeted blood flow rates of 350ml/min, the entire bloodstream of an average size person can be processed through Sigyn Therapy^TM approximately fifteen times during a single four-hour treatment period.

From a technical perspective, Sigyn Therapy^TM 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^TM, 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^TM 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^TM 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^TM.

Opportunities to Address Unmet Needs in Global Health

Based on data obtained during pre-clinical in vitro validation studies, we are advancing Sigyn Therapy^TMto address several unmet needs in global health. These include untreatable viral pathogen, antibiotic resistant bacterial infections, endotoxemia, and sepsis.

Untreatable Viral Pathogens

A majority of 200+ viruses that are known to be infectious to humans are not treatable with drug therapies. Furthermore, newly emerging viruses will remain drug-resistant until a corresponding drug is developed and demonstrated to be safe and effective in human studies. As a result, extracorporeal blood purification therapies are increasingly being deployed as first-line treatment countermeasures.

The first blood purification device to receive FDA Emergency-Use Authorization approval to treat a pandemic virus was the Hemopurifier to treat Ebola, which occurred under the leadership of our CEO at a previous company. Subsequently, the first therapies to receive FDA Emergency-Use Authorization to treat Covid-19 were blood purification therapies from Terumo BCT, ExThera Medical Corporation, CytoSorbents, Inc., and Baxter Healthcare Corporation. In connection with these approvals, 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 their bloodstream.

Consistent with FDA’s statement, pediatric versions of Sigyn Therapy^TM have demonstrated an ability to reduce the presence of various pathogens, cytokines, and other inflammatory mediators from human blood plasma. As such, we believe Sigyn Therapy^TM offers an important candidate strategy to treat future pandemic outbreaks, which are increasingly being fueled by a confluence of global warming, urban crowding, and intercontinental travel.

Additionally, as many infectious 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. Sigyn Therapy^TM also aligns with government initiatives to support the development of broad-spectrum medical countermeasures that could help mitigate the impact of an emerging pandemic or bioterror threat yet may also have viability in established disease indications.

Antibiotic-Resistant Bacterial Infections

According to the U.S. Centers for Disease Control and Prevention (“CDC”), nearly three million individuals are infected with antibiotic resistant bacterial infections in the U.S. each year, which results in more than 35,000 deaths. The United Nations reported approximately 5 million deaths worldwide in 2019 were associated with antimicrobial drug resistance and projects the annual death toll could increase to 10 million by 2050 in the absence of new therapeutic advances. Based on its broad-spectrum mechanism to extract bacterial toxins and inflammatory mediators from the bloodstream, Sigyn Therapy^TM may provide a novel strategy to assist in the treatment of antibiotic-resistant bacterial infections.

Endotoxemia

Endotoxin is a gram-negative bacterial toxin whose bloodstream presence commonly induces sepsis, the leading cause of death in U.S. hospitals. Our initial clinical focus is directed toward the treatment of end-stage renal disease (ESRD) patients who suffer from endotoxemia and concurrent inflammation, which are prevalent, yet untreatable conditions that shorten the lives of dialysis patients.

According to the United States Renal Data System (“USRDS”), more than 550,000 individuals have ESRD, which results in approximately 85 million kidney dialysis treatments being administered in the United States each year. A therapy that could help extend the lives of these patients may have a quantifiable value to the dialysis industry, which is dominated by Fresenius Medical Care and DaVita, Inc. in North America. Based on the number of ESRD patients treated in their networks, every month of extended life would equate to approximately $1 billion in added revenues for each company.

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,” 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 a growing interest in multi-mechanism therapies that can simultaneously address both inflammatory and pathogen associated targets. Sigyn Therapy^TM offers to addresses a broad-spectrum of pathogen sources and the resulting dysregulated cytokine production (the cytokine storm) that is a hallmark of sepsis.

Emerging Opportunity for Sigyn Therapy^TM in Xenotransplantation

Beyond the post-exposure treatment of infectious disease disorders, Sigyn Therapy^TM offers a potential preventative strategy to reduce the spread of infection in organ transplantation, including xenotransplantation, an emerging field related to the transplantation of an organ from a donor animal species into a human recipient. The advancement of xenotransplantation is being fueled by a global shortage of transplantable human organs and the recent emergence of gene-editing technologies that have increased the compatibility of porcine-derived (pig) kidneys for human transplantation. In the United States, approximately 90,000 individuals are on the waitlist for a kidney transplant, yet fewer than 30,000 kidney transplants are performed each year.

To optimize xenotransplantation outcomes, Sigyn Therapy^TM is proposed for administration to:

Devices to Optimize the Benefit of Cancer Therapies

Unlike Sigyn Therapy^TM to treat infectious disease disorders, the intent of ImmunePrep^TM and ChemoPrep^TMis to optimize the delivery of leading drugs to treat cancer, while ChemoPure^TM introduces a strategy to reduce chemotherapy toxicity. Additionally, Sigyn Therapy^TM is a hollow fiber-based device deployed for use on dialysis and continuous renal replacement machines. Whereas ImmunePrep^TM, ChemoPrep^TM and ChemoPure^TM do not contain hollow-fibers and are intended for use on portable blood processing systems that can be located within the clinical sites where cancer therapies are infused to patients. During treatment, the functionality of the blood processing system allows for patient blood plasma to flow through our devices, which in the case of ImmunePrep^TM products, therapeutic antibodies are immobilized for selective elimination of drug decoys and antibody therapeutic targets from the bloodstream. ChemoPrep^TM and ChemoPure^TMincorporate adsorbent components to reduce the circulating presence of particles that interfere with chemotherapy delivery and to extract off-target chemotherapy from the bloodstream as a means to reduce toxicity.

ImmunePrep^TMto Optimize Immunotherapeutic Antibodies

ChemoPrep^TMto Optimize Chemotherapy Delivery

ChemoPure^TMto Reduce Chemotherapy Toxicity

Marketing and Sales

Our primary focus is the regulatory and clinical advancement of Sigyn Therapy^TM and the continued development of our cancer treatment technologies. We do not market or sell any therapeutic products at this time. However, we may choose to forge relationships with organizations that have established distribution channels into markets that may have a demand for our therapies should they 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 CEO and other employee inventors. We have also received a “Notice of Allowance” from the USPTO related to the use of Sigyn Therapeutics, Sigyn Therapy^TM, 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 (i.e., the priority date) and will expire at the end of such 20-year terms.

At present, we own the rights to the following patents pending.

EXTRACORPOREAL THERAPIES FOR XENOTRANSPLANTATION – U.S. Patent Application No.: 63/707,507; Priority Date: 10/15/2024 - Inventors: James A. Joyce and Annette M. Marleau

DEVICES FOR ENHANCING THE ACTIVITY OF THERAPEUTIC ANTIBODIES – Internatio