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 ~~March~~June 3130, 2025

☐ 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
2305 Historic Decatur Road Ste., 100, San Diego, California		92106
(Address of principal executive offices)		(zip code)

(619) 353-0800

(Registrant’s telephone number, including area code)

2468 Historic Decatur Road, Suite 140

San Diego, California 92106

(Former name, former address and former fiscal year, if changed since last report)

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 ~~May~~September 205, 2025, there were 1,605,377 shares of common stock outstanding.

SIGYN THERAPEUTICS, INC.

TABLE OF CONTENTS

Heading		Page
PART I – FINANCIAL INFORMATION		4
Item 1.	Financial Statements	4
	Unaudited Condensed Consolidated Balance Sheets as of March 31, 2025 and December 31, 2024	4
	Unaudited Condensed Consolidated Balance Sheets as of June 30, 2025 and December 31, 2024	4
	Unaudited Condensed Consolidated Statements of Operations for the Three months ended March 31, 2025 and 2024	5
	Unaudited Condensed Consolidated Statements of Operations for the Three and six months ended June 30, 2025 and 2024	5
	Unaudited Condensed Consolidated Statements of Stockholders’ Deficit for the Three months ended March 31, 2025 and 2024	6
	Unaudited Condensed Consolidated Statements of Stockholders’ Deficit for the Three and six months ended June 30, 2025 and 2024	6
	Unaudited Condensed Consolidated Statements of Cash Flows for the Three months ended March 31, 2025 and 2024	7
	Unaudited Condensed Consolidated Statements of Cash Flows for the Six months ended June 30, 2025 and 2024	7
	Notes to the Unaudited Condensed Consolidated Financial Statements	8
Item 2.	Management’s Discussion and Analysis of Financial Condition and Results of Operations	2526
Item 3.	Quantitative and Qualitative Disclosures About Market Risk	4446
Item 4.	Controls and Procedures	4446
PART II – OTHER INFORMATION
Item 1.	Legal Proceedings	4547
Item1A.	Risk Factors	4647
Item 2.	Unregistered Sales of Equity Securities and Use of Proceeds	4647
Item 3.	Defaults Upon Senior Securities	4647
Item 4.	Mine Safety Disclosure	4648
Item 5.	Other Information	4648
Item 6.	Exhibits	4748
SIGNATURES		4851

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

	March 31,			December 31,
	June 30,			December 31,
	2025			2024
ASSETS
Current assets:
Cash	$	~~12,895~~459		$	12,144
Other current assets		551,~~200~~300			9,100
Total current assets		681,~~095~~759			21,244
Property and equipment, net		~~8,322~~-			9,685
Operating lease right-of-use assets, net		~~97,181~~-			112,079
Other assets		7050,~~711~~000			70,711
Total assets	$	~~244~~51,~~309~~759		$	213,719
LIABILITIES AND STOCKHOLDERS’ DEFICIT
Current liabilities:
Accounts payable	$	~~672~~729,~~040~~846		$	608,384
Accrued payroll and payroll taxes		2,~~005~~186,~~147~~086			1,868,973
Short-term promissory notes, less unamortized debt issuance costs of $101,080 and $139,794, respectively		212,920			174,206
Short-term promissory notes, less unamortized debt issuance costs of $61,938 and $139,794, respectively		262,062			174,206
Short-term convertible notes payable, less unamortized debt issuance costs of $212,409 and $130,252, respectively		2,189,296			1,891,736
Short-term convertible notes payable, less unamortized debt issuance costs of $181,719 and $130,252, respectively		2,307,986			1,891,736
Current portion of operating lease liabilities		~~72,300~~-			69,946
Other current liabilities		~~312~~3,408			1,742
Total current liabilities		5,~~152~~489,~~015~~388			4,614,987
Long-term liabilities:
Operating lease liabilities, net of current portion		~~37,501~~-			56,356
Total long-term liabilities		~~37,501~~-			56,356
Total liabilities		5,~~189~~489,~~516~~388			4,671,343
Stockholders’ deficit:
Preferred stock, $0.0001 par value, 10,000,000 shares authorized; 2,403 shares issued and outstanding at March 31, 2025 and December 31, 2024, respectively		-			-
Preferred stock, $0.0001 par value, 10,000,000 shares authorized; 5,107 and 2,403 shares issued and outstanding at June 30, 2025 and December 31, 2024, respectively		-			-
Common stock, $0.0001 par value, 100,000,000 shares authorized; 1,605,377 shares issued and outstanding at March 31, 2025 and December 31, 2024, respectively		161			161
Common stock, $0.0001 par value, 100,000,000 shares authorized; 1,605,377 shares issued and outstanding at June 30, 2025 and December 31, 2024, respectively		161			161
Additional paid-in capital		1011,~~404~~363,~~920~~685			10,223,939
Accumulated deficit		(1516,~~350~~801,~~288~~475	)		(14,681,724	)
Total stockholders’ deficit		(45,~~945~~437,~~207~~629	)		(4,457,624	)
Total liabilities and stockholders’ deficit	$	~~244~~51,~~309~~759		$	213,719

See accompanying notes to unaudited condensed consolidated financial statements.

SIGYN THERAPEUTICS, INC.

UNAUDITED CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS

	Three Months Ended March 31,
	Six Months Ended June 30,						Three Months Ended June 30,
	2025			2024			2025			2024
Net revenues	$	-		$	-		$	-		$	-
Gross Profit		-			-			-			-
Operating expenses:
Marketing expenses		~~176~~184			~~338~~346			8			8
Stock based compensation		50100,000			3775,~~500~~000			50,000			37,500
Research and development		816,~~842~~323			~~232~~473,~~593~~022			7,482			240,429
General and administrative		~~487~~899,~~041~~065			~~359~~684,~~541~~406			412,023			324,868
Total operating expenses		~~546~~1,~~059~~015,572			~~629~~1,~~972~~232,774			469,513			602,805
Loss from operations		(~~546~~1,~~059~~015,572	)		(~~629~~1,~~972~~232,774	)		(469,513	)		(602,805	)
Other expense:
Modification of warrants		-			-
Other income		(5,797	)		-			(5,797	)		-
Interest expense		448			1,510
Modification of warrants		17,505			-			17,505			-
Interest expense - debt discount		27,704			43,207
Inducement of preferred shares		845,901			-			845,901			-
Interest expense - original issuance costs		94,353			83,399
Interest expense		1,321			2,081			873			569
Total other expense		122,505			128,116
Interest expense - debt discount		69,879			159,944			42,175			116,737
Loss before income taxes		(668,564	)		(758,088	)
Interest expense - original issuance costs		175,370			225,672			81,017			142,272
Income taxes		-			-
Total other expense		1,104,179			387,697			981,674			259,578
Net loss	$	(668,564	)	$	(758,088	)
Loss before income taxes		(2,119,751	)		(1,620,471	)		(1,451,187	)		(862,383	)
Net loss per share, basic and diluted	$	(0.42	)	$	(0.62	)
Income taxes		-			-			-			-
Weighted average number of shares outstanding
Net loss	$	(2,119,751	)	$	(1,620,471	)	$	(1,451,187	)	$	(862,383	)
Basic and diluted		1,605,377			1,230,354
Net loss per share, basic and diluted	$	(1.32	)	$	(1.31	)	$	(0.90	)	$	(0.70	)
Weighted average number of shares outstanding
Basic and diluted		1,605,377			1,234,241			1,605,377			1,238,085

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, 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	)
Balance as of December 31, 2024		2,403	$	-		1,605,377		$	161		$	10,223,939	$	(14,681,724	)	$	(4,457,624	)
Common stock issued to third parties in conjunction with conversion of debt		-		-		38,826			4			232,933		-			232,937
Balance		2,403	$	-		1,605,377		$	161		$	10,223,939	$	(14,681,724	)	$	(4,457,624	)
Preferred stock issued to third parties in conjunction with conversion of debt		1,116		-		-			-			841,419		-			841,419
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 as of December 31, 2024		2,403		-		1,605,377			161			10,223,939		14,681,724			(4,457,624	)
Stock based compensation		-		-		-			-			50,000		-			50,000
Warrants issued to third parties in conjunction with debt issuance		-		-		-			-			130,981		-			130,981
Net loss		-		-		-			-			-		(668,564	)		(668,564	)
Balance as of March 31, 2025		2,403	$	-		1,605,377		$	161		$	10,404,920	$	(15,350,288	)	$	(4,945,207	)
Balance		2,403	$	-		1,605,377		$	161		$	10,404,920	$	(15,350,288	)	$	(4,945,207	)
Stock based compensation		-		-		-			-			50,000		-			50,000
Warrants issued to third parties in conjunction with debt issuance		-		-		-			-			45,359		-			45,359
Modification of warrants		-		-		-			-			17,505		-			17,505
Inducement of preferred shares		2,704		-		-			-			845,901		-			845,901
Net loss		-		-		-			-			-		(1,451,187	)		(1,451,187	)
Balance as of June 30, 2025		5,107	$	-		1,605,377		$	161		$	11,363,685	$	(16,801,475	)	$	(5,437,629	)
Balance		5,107	$	-		1,605,377		$	161		$	11,363,685	$	(16,801,475	)	$	(5,437,629	)

See accompanying notes to unaudited condensed consolidated financial statements.

SIGYN THERAPEUTICS, INC.

UNAUDITED CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS

	Three Months Ended March 31,
	Six Months Ended June 30,
	2025			2024
Cash flows from operating activities:
Net loss	$	(~~668~~2,~~564~~119,751	)	$	(~~758~~1,~~088~~620,471	)
Adjustments to reconcile net loss to net cash used in operating activities:
Depreciation expense		1,363			12,~~523~~885
Stock based compensation		50100,000			3775,~~500~~000
Accretion of debt discount		2769,~~704~~879			43159,~~207~~943
Accretion of original issuance costs		94175,~~353~~370			83225,~~399~~672
Modification of warrants		-17,505			-
Inducement of preferred shares		845,901			-
Settlement of lease		(5,798	)		-
Changes in operating assets and liabilities:
Other current assets		37,~~900~~697			413,~~783~~641
Accounts payable		63,656			67,804
Other assets		20,711			-
Accrued payroll and payroll taxes		136,174			285,908
Accounts payable		121,462			26,718
Other current liabilities		(3,032	)		(1,648	)
Accrued payroll and payroll taxes		317,113			701,399
Net cash used in operating activities		(294,446	)		(235,612	)
Other current liabilities		1,666			(3,193	)
Cash flows from investing activities:
Net cash used in operating activities		(446,882	)		(418,406	)
None		-			-
Net cash used in investing activities		-			-
Cash flows from financing activities:
Proceeds from short-term convertible notes		~~295~~425,197			~~251~~470,~~760~~360
Advance from shareholder		-			25,000
Proceeds from short-term promissory notes		10,000			-
Repayments of advance from shareholder		-			(20,000	)
Advance from shareholder		-			35,000
Net cash provided by financing activities		295,197			256,760
Repayments of advance from shareholder		-			(45,000	)
Net (decrease) increase in cash		751			21,148
Net cash provided by financing activities		435,197			460,360
Net (decrease) increase in cash		(11,685	)		41,954
Cash at beginning of period		12,144			11,690
Cash at end of period	$	~~12,895~~459		$	3253,~~838~~644
Supplemental disclosures of cash flow information:
Cash paid during the period for:
Interest	$	-		$	-
Income taxes	$	-		$	-
Non-cash investing and financing activities:
Subscription receivable in conjunction with debt issuance	$	50,000		$	-
Warrants issued to third parties in conjunction with debt issuance	$	176,340		$	211,475
Warrants issued to third parties in conjunction with debt issuance	$	130,981		$	111,834
Original issue discount issued in conjunction with debt	$	42,520		$	106,386
Original issue discount issued in conjunction with debt	$	34,520		$	25,176
Common stock issued to third parties in conjunction with conversion of debt	$	-		$	232,936
Preferred stock issued to third parties in conjunction with conversion of debt		-			841,419
Cancellation of common stock – related party		-			7

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:

	1.	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.

	2.	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”).

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 $1516,~~350~~801,~~288~~475 at ~~March~~June 3130, 2025, had a working capital deficit of $5,~~083~~487,~~920~~629 at ~~March~~June 3130, 2025, had net losses of $~~668~~1,~~564~~451,187 and $~~758~~2,~~088~~119,751, and $862,383 and $1,620,471 for the three and six months ended ~~March~~June 3130, 2025 and 2024, respectively, and net cash used in operating activities of $~~294,~~446,882 and $~~235~~418,~~612~~406 for the ~~three~~six months ended ~~March~~June 3130, 2025 and 2024, respectively, with no revenue earned since inception, and a lack of operational history. These matters raise substantial doubt about the Company’s ability to continue as a going concern.

While the Company is attempting to expand operations and increase revenues, the Company’s cash position may not be significant enough to support the Company’s daily operations. Management intends to raise additional funds by way of a public offering or an asset sale transaction. Management believes that the actions presently being taken to further implement its business plan and generate revenues provide the opportunity for the Company to continue as a going concern. While management believes in the viability of its strategy to generate revenues and in its ability to raise additional funds or transact an asset sale, there can be no assurances to that effect or on terms acceptable to the Company. The ability of the Company to continue as a going concern is dependent upon the Company’s ability to further implement its business plan and generate revenues.

The financial statements do not include any adjustments that might be necessary if the Company is unable to continue as a going concern 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.

Advertising and Marketing Costs

Advertising expenses are recorded as general and administrative expenses when they are incurred. The Company had $~~176~~8 and $~~338~~184, ofand $8 and $346 of advertising expenses for the three and six months ended ~~March~~June 3130, 2025 and 2024, respectively.

Research and Development

All research and development costs are expensed as incurred. The Company incurred research and development expense of $87,~~842~~482 and $~~232~~16,~~593~~323, and $240,429 and $473,022 for the three and six months ended ~~March~~June 3130, 2025 and 2024, 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 ~~March~~June 3130, 2025 and December 31, 2024, 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~~ 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 ~~March~~June 3130, ~~2024~~2025. 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. As the Company does not have any current plans to dispose of the inventory, the Company included the inventory in Other Assets in the unaudited condensed Consolidated Balance Sheets as of ~~March~~June 3130, 2025 and December 31, 2024.

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 ~~March~~June 3130, 2025 and December 31, 2024, 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 ~~March~~June 3130, 2025 and December 31, 2024, 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 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 ~~March~~June 3130, 2025 and December 31, 2024 and no charges or credits to income for the three and six months ended ~~March~~June 3130, 2025 and 2024.

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 derivative treatment, 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 statement of operations over the contract period. When it is appropriate for the Company to recognize the cost of a transaction during financial reporting periods prior to the measurement date, for purposes of recognition of costs during those periods, the equity instrument is measured at the then-current fair values at each of those interim financial reporting dates.

Concentrations, Risks, and Uncertainties

Business Risk

Substantial business risks and uncertainties are inherent to an entity, including the potential risk of business failure.

The Company is headquartered and operates in the United States. To date, the Company has generated no revenues from operations. There can be no assurance that the Company will be able to raise additional capital and failure to do so would have a material adverse effect on the Company’s financial position, results of operations and cash flows. Also, the success of the Company’s operations is subject to numerous contingencies, some of which are beyond management’s control. Currently, these contingencies include general economic conditions, price of components, competition, and governmental and political conditions.

Interest rate risk

Financial assets and liabilities do not have material interest rate risk.

Credit risk

The Company is exposed to credit risk from its cash in banks. The credit risk on cash in banks is limited because the counterparties are recognized financial institutions.

Seasonality

The business is not subject to substantial seasonal fluctuations.

Major Suppliers

Sigyn Therapy is comprised of components that are supplied by various industry vendors. Additionally, the Company is reliant on third-party organizations to conduct clinical development studies that are necessary to advance Sigyn Therapy toward the marketplace.

Should the relationship with an industry vendor or third-party clinical development organization be interrupted or discontinued, it is believed that alternate component suppliers and third-party clinical development organizations could be identified to support the continued advancement of Sigyn Therapy.

Recent Accounting Pronouncements

There are no recently issued accounting updates that are expected to have a material impact on the Company’s consolidated financial statements except for:

In November 2024, the FASB issued ASU 2024-03, “Income Statement—Reporting Comprehensive Income—Expense Disaggregation Disclosures (Subtopic 220-40): Disaggregation of Income Statement Expenses,” which is intended to improve disclosures about a public business entity’s expenses and address requests from investors for more detailed information about the types of expenses in commonly presented expense captions. Such information should allow investors to better understand an entity’s performance, assess future cash flows, and compare performance over time and with other entities. The amendments will require public business entities to disclose in the notes to the financial statements, at each interim and annual reporting period, specific information about certain costs and expenses, including purchases of inventory, employee compensation, depreciation, and intangible asset amortization included in each expense caption presented on the face of the income statement, and the total amount of an entity’s selling expenses. The amendments are effective for annual reporting periods beginning after December 15, 2026, and interim reporting periods beginning after December 15, 2027, and may be applied either prospectively or retrospectively. Early adoption is permitted. The Company is currently evaluating the impact of adopting this guidance on the consolidated financial statements.

NOTE 4 – PROPERTY AND EQUIPMENT

Property and equipment consisted of the following as of:

SCHEDULE OF PROPERTY AND EQUIPMENT

		March 31,			December 31,
		June 30,			December 31,
	Estimated Life	2025			2024
Office equipment	5 years	$	~~29,041~~-		$	29,041
Property and equipment, gross	5 years	$	29,041		$	29,041
Computer equipment	3 years		-			3,157
Accumulated depreciation			(23,876	)		(22,513	)
Property and equipment, gross	3 years		-			3,157
Property and equipment, net		$	8,322		$	9,685
Accumulated depreciation			-			(22,513	)
Property and equipment, net		$	-		$	9,685

Depreciation expense was $0 and $1,363, and $1,~~523~~364 and $2,885 for the three and six months ended ~~March~~June 3130, 2025 and 2024, 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 ~~March~~June 3130, 2025			Outstanding Balance as of December 31, 2024
Osher Capital Partners LLC
January 28, 2020 (“Note 1”)	August 31, 2025	$	350,005	$	620,553		$	620,553
June 22, 2022 (“Note 2”)	August 31, 2025		75,000		103,745			103,745
August 31, 2022 (“Note 2”)	August 31, 2025		100,000		135,520			135,520
September 20, 2022 (“Note 2”)	August 31, 2025		100,000		135,520			135,520
October 20, 2022 (“Note 2”)	March 31, 2025		100,000		127,000			127,000
November 14, 2022 (“Note 2”)	March 31, 2025		50,000		64,350			64,350
December 22, 2022 (“Note 2”)	March 31, 2025		100,000		125,000			125,000
July 18, 2023 (“Note 3”)	August 31, 2025		60,000		72,600			72,600
December 7, 2023 (“Note 3”)	August 31, 2025		40,000		48,400			48,400
May 13, 2024 (“Note 4”)	May 13, 2025		35,000		40,000			40,000
August 19, 2024 (“Note 4”)	August 19, 2025		7,500		8,250			8,250
November 19, 2024 (“Note 4”)	November 19, 2025		8,000		8,800			8,800
April 15, 2025	April 15, 2026		20,000		22,000			-
Brio Capital Master Fund, Ltd.
March 23, 2022 (“Note 2”)	August 31, 2025		100,000		142,960			142,960
November 9, 2022 (“Note 2”)	August 31, 2025		75,000		101,640			101,640
January 20, 2023 (“Note 3”)	March 31, 2025		50,000		62,500			62,500
February 9, 2023 (“Note 3”)	March 31, 2025		50,000		62,500			62,500
July 20, 2023 (“Note 3”)	August 31, 2025		40,000		48,400			48,400
January 8, 2024 (“Note 4”)	January 8, 2025		40,000		44,000			44,000
May 13, 2024 (“Note 4”)	May 13, 2025		35,000		40,000			40,000
August 20, 2024 (“Note 4”)	August 20, 2025		11,500		12,650			12,650
November 19, 2024 (“Note 4”)	November 19, 2025		8,000		8,800			8,800
April 23, 2025	April 23, 2026		10,000		11,000			-
Various third-party noteholders
Various dates in fiscal 2024 (“Note 4”)	November 19, 2025		650,890		8,800			8,800
Various dates in fiscal 2025 (“Note 5”)	Through June 2026		50,000		55,000			-
FY 2025 Regulation D	Primarily January 9, 2026		345,197		379,717			-
Total convertible notes payable		$	2,~~431~~511,092	$	2,~~401~~489,705		$	2,021,988
Original issue discount					(9662,~~749~~874	)		(117,868	)
Debt discount					(~~115~~118,~~660~~845	)		(12,384	)
Total convertible notes payable				$	2,~~189~~307,~~296~~986		$	1,891,736

Principal payments on convertible promissory debentures are due as follows:

Year ending December 31,
2025 (excluding the three months ended March 31, 2025)	$	2,021,988
2025 (excluding the six months ended June 30, 2025)	$	2,401,705
2026		~~379~~88,~~717~~000
Long-Term Debt	$	2,~~401~~489,705

Changes in convertible notes were as follows:

SCHEDULE OF CHANGES IN ~~NOTE~~CONVERTIBLE ~~DISCOUNTS~~NOTES

	Note 1			Note 2			Note 3			Note 4			Reg D		~~Totals~~Note 5			Totals
Convertible notes payable as of December 31, 2022	$	700,816		$	1,578,500		$	-		$	-		$	-	$	2,279,316
Convertible notes payable as of December 31, 2023	$	864,136		$	1,379,500		$	264,000		$	-		$	-	$	-		$	2,507,636
Convertible notes payable issued in 2023		163,320			142,000			1,443,200			-			-		1,748,520
Convertible notes payable issued in 2024		56,416			97,655			30,400			879,029			-		-			1,063,500
Conversion of debt for common stock		-(299,999	)		(~~341~~541,~~000~~419	)		~~(1,179,200~~-	)		-(707,730	)		-		~~(1,520,200~~-	)		(1,549,148	)
Convertible notes payable as of December 31, 2023	$	864,136		$	1,379,500		$	264,000		$	-		$	-	$	2,507,636
Convertible notes payable as of December 31, 2024	$	620,553		$	935,736		$	294,400		$	171,299		$	-	$	-		$	2,021,988
Convertible notes payable issued in 2024		56,416			97,655			30,400			879,029			-		1,063,500
Convertible notes payable as of beginning balance	$	620,553		$	935,736		$	294,400		$	171,299		$	-	$	-		$	2,021,988
Conversion of debt for common stock		(299,999	)		(541,419	)		-			(707,730	)		-		(1,549,148	)
Convertible notes payable issued in 2025		-			-			-			-			379,717		88,000			467,717
Convertible notes payable as of December 31, 2024	$	620,553		$	935,736		$	294,400		$	171,299		$	-	$	2,021,988
Convertible notes payable issued		-			-			-			-			379,717		88,000			467,717
Convertible notes payable as of beginning balance	$	620,553		$	935,736		$	294,400		$	171,299		$	-	$	2,021,988
Convertible notes payable as of June 30, 2025	$	620,553		$	935,736		$	294,400		$	171,299		$	379,717	$	88,000		$	2,489,705
Convertible notes payable issued in 2025		-			-			-			-			379,717		379,717
Convertible notes payable as of ending balance	$	620,553		$	935,736		$	294,400		$	171,299		$	379,717	$	88,000		$	2,489,705
Conversion of debt for common stock		-			-			-			-			-		-
Convertible notes payable as of March 31, 2025	$	620,553		$	935,736		$	294,400		$	171,299		$	379,717	$	2,401,705
Convertible notes payable as of ending balance	$	620,553		$	935,736		$	294,400		$	171,299		$	379,717	$	2,401,705

Changes in note discounts were as follows:

SCHEDULE OF CHANGES IN NOTE DISCOUNTS

	Note 1			Note 2			Note 3			Note 4			Reg D			~~Totals~~Note 5			Totals
Note discounts as of December 31, 2023	$	114,995		$	100,810		$	81,532		$	-		$	-		$	~~297,337~~-		$	297,337
Note discounts issued in conjunction with debt in 2024		56,414			97,657			30,400			487,771			-			~~672,242~~			672,242
2024 accretion of note discounts		(129,214	)		(145,792	)		(95,981	)		(468,340	)		-			~~(839,327~~	)		(839,327	)
Note discounts as of December 31, 2024	$	42,195		$	52,675		$	15,951		$	19,431		$	-		$	130,252
Note discounts as of Dec 31, 2024	$	42,195		$	52,675		$	15,951		$	19,431		$	-		$	-		$	130,252
Note discounts as of beginning balance	$	42,195		$	52,675		$	15,951		$	19,431		$	-		$	~~130,252~~-		$	130,252
Note discounts issued in conjunction with debt in 2025		-			-			-			-			165,500			~~165~~53,~~500~~360			218,860
Note discounts issued in conjunction with debt		-			-			-			-			165,500			~~165~~53,~~500~~360			218,860
2025 accretion of note discounts		(1327,~~910~~975	)		(2438,~~080~~120	)		(711,~~496~~335	)		(710,~~053~~840	)		(3072,~~804~~061	)		(837,~~343~~062	)		(167,393	)
Note discounts as of March 31, 2025	$	28,285		$	28,595		$	8,455		$	12,378		$	134,696		$	212,409
Accretion of note discounts		(27,975	)		(38,120	)		(11,335	)		(10,840	)		(72,061	)		(7,062	)		(167,393	)
Note discounts as of ending balance	$	28,285		$	28,595		$	8,455		$	12,378		$	134,696		$	212,409
Note discounts as of June 30, 2025	$	14,220		$	14,555		$	4,616		$	8,591		$	93,439		$	46,298		$	181,719
Convertible notes payable, net, as of Dec 31, 2024	$	578,358		$	883,061		$	278,449		$	151,868		$	-		$	1,891,736
Note discounts as of ending balance	$	14,220		$	14,555		$	4,616		$	8,591		$	93,439		$	46,298		$	181,719
Convertible notes payable, net, as of March 31, 2025	$	592,268		$	907,141		$	285,945		$	158,921		$	245,021		$	2,189,296
Convertible notes payable, net, as of Dec 31, 2024	$	578,358		$	883,061		$	278,449		$	151,868		$	-		$	-		$	1,891,736
Convertible notes payable, net	$	592,268		$	907,141		$	285,945		$	158,921		$	245,021		$	2,189,296
Convertible notes payable, net, as of June 30, 2025	$	606,333		$	921,181		$	289,784		$	162,708		$	286,278		$	41,702		$	2,307,986
2024 Effective interest rate		21	%		16	%		33	%		273	%		-%			42	%
Convertible notes payable, net	$	606,333		$	921,181		$	289,784		$	162,708		$	286,278		$	41,702		$	2,307,986
2025 Effective interest rate		2	%		3	%		3	%		4	%		8	%		3	%
2024 Effective interest rate		21	%		16	%		33	%		273	%		-%			-%			42	%
2025 Effective interest rate		5	%		4	%		4	%		6	%		19	%		8	%		7	%

Current Noteholders

Regulation D

On January 9, 2025, the Company initiated a Regulation D offering to sell up to 750,000 Units at a price of $5,000 per unit with each Unit consisting of one (1) $5,500 principal amount convertible debenture (convertible at ~~four~~two dollars ($42.00) per share into the Company’s common stock) and a Warrant to purchase 1,250 shares of common stock at $64.00 per share. The Debentures have a principal amount equal to 110% of such Purchaser’s subscription amount, convertible at $42.00 per share and maturing one (1) year from the date the subscription amount is accepted by the Company. The Warrants for a number of shares equal to the subscription amount divided by the conversion price with an exercise price of $64.00 per share, exercisable upon issuance and will expire five years from issuance. The Debentures will not be redeemable but contain an automatic conversion feature, which will cause all principal and interest due under the Debenture to automatically convert if our common stock is listed for trading on a national securities exchange, such as NASDAQ or the NYSE. As of ~~March~~June 3130, 2025, a total of 69 Units were sold to accredited investors at a price of $5,500 per Unit totaling $379,717 (total of $~~295~~345,197 cash was received ~~and $50,000 as a subscription receivable~~).

2025 Convertible Notes (Note 5)

During fiscal 2025, the Company entered into Original Issue Discount Senior Convertible Debentures (the “2025 Notes”) totaling (i) $88,000 aggregate principal amount of Notes (total of $80,000 cash was received) due between April and June 2026 based on $1.00 for each $0.90909 paid by the noteholders and (ii) five-year 5 Common Stock Purchase Warrants (“Warrants”) to purchase up to an aggregate of 44,000 shares of the Company’s Common Stock at an exercise price of $4.00 per share. The aggregate cash subscription amount received by the Company for the issuance of the Note and Warrants was $80,000 which was issued at a $8,000 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 $2.00 per share, subject to adjustment as provided therein, such as stock splits and stock dividends.

2024 Convertible Notes (Note 4)

During fiscal 2024, the Company entered into Original Issue Discount Senior Convertible Debentures (the “2024 Notes”) totaling (i) $879,029 aggregate principal amount of Notes (total of $795,890 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 5 Common Stock Purchase Warrants (“Warrants”) to purchase up to an aggregate of 219,758 shares of the Company’s Common Stock at an exercise price of $64.00 per share. The aggregate cash subscription amount received by the Company for the issuance of the Note and Warrants was $795,890 which was issued at a $83,139 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 $42.00 per share, subject to adjustment as provided therein, such as stock splits and stock dividends.

The Company has not repaid the Brio January 8, 2024 convertible note of $44,000 that matured on January 8, 2025 and the convertible note is now in default. The Company is currently in discussions to restructure the terms 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 and June 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) $294,400 ~~aggregate~~ aggregate principal amount of Notes (total of $240,000 ~~cash~~ 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 5 Common Stock Purchase Warrants (“Warrants”) to purchase up to an aggregate of 66,000 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 $54,400 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 $42.00 per share, subject to adjustment as provided therein, such as stock splits and stock dividends.

The Company has not repaid two Brio convertible notes totaling $125,000 that matured on March 31, 2025 and the convertible notes are now in default. The Company is currently in discussions to restructure the terms of these 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 (Note 2)

During fiscal 2022, the Company entered into Original Issue Discount Senior Convertible Debentures (the “2022 Notes”) totaling (i) $935,735 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 5 ~~Common~~ Common Stock Purchase Warrants (“Warrants”) to purchase up to an aggregate of 192,500 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 $42.00 per share, subject to adjustment as provided therein, such as stock splits and stock dividends.

The Company has not repaid three Osher convertible notes totaling $316,350 that matured on March 31, 2025 and the convertible notes are now in default. The Company is currently in discussions to restructure the terms of these notes.

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 – $620,553 (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) $620,553 ~~aggregate~~ 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) 5 five-year 5 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 $270,548 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 –PROMISSORY NOTES

On June 9, 2025, the Company entered into a promissory note of $10,000 due July 31, 2025 and is non-interest bearing.

On November 26, 2024, the Company entered into promissory notes totaling $314,000 aggregate principal amount of promissory notes (total of $157,000 cash was received) due November 26, 2025 based on $1.00 for each $0.50 paid by the noteholders which were issued at a $157,000 original issue discount from the face value of the promissory notes.

NOTE 7 – STOCKHOLDERS’ DEFICIT

Preferred Stock

The Company authorized 10,000,000 shares of par value $0.0001 preferred stock, of which 25,~~403~~107 and 2,403 shares are issued and outstanding as of ~~March~~June 3130, 2025 and December 31, 2024, respectively.

On June 5, 2025, as a means to induce further investment from established or candidate shareholders, the Company issued four (4) Series B preferred shares for each $5,000 of shares previously converted by a Convertible Debenture noteholder. The Company recorded a total inducement of 2,704 Series B preferred shares, valued at $845,901 (based on the estimated fair value of the stock on the date of grant) in the unaudited condensed consolidated Statements of Operations.

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.

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

On December 30, 2024, the Company filed a Certificate of Amendment to our Amended and Restated Certificate of Incorporation with the State of Delaware, which went effective immediately upon filing. The Certificate of Amendment decreased our authorized common stock to One Hundred Million (100,000,000) shares, par value $0.0001, of which 1,605,377 and 1,605,377 shares are outstanding as of ~~March~~June 3130, 2025 and December 31, 2024, respectively.

During the year ended December 31, 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 year ended December 31, 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.

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 January 11, 2025 and October 10, 2022, the Company’s Board of Directors appointed Mr. Michael Ryan, and Ms. Richa Nand, Mr. Jim Dorst, and Mr. Chris Wetzel, respectively, as non-executive members to the Company’s Board of Directors (“Director”). Effective January 1, 2023, each Director shall receive an annual grant of restricted stock units of $50,000. During the three ~~months~~and six months ended ~~March~~June 3130, 2025 and 2024, respectively, the Company recorded stock-based compensation totaling $50,000 and $100,000, and $37,500 and $75,000, respectively, in the unaudited condensed consolidated Statements of Operations.

Reverse Stock Split

Effective January 19, 2024, the 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.

Warrants

On June 5, 2025, as a means to induce further investment from established shareholders, the Company adjusted the conversion price of the Company’s outstanding warrants from $6.00 per share to $4.00 per share. The Company recognized a loss of $17,505 due to the modification of the warrants in June 2025 in the unaudited condensed consolidated Statements of Operations.

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 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 gain of $63,715 due to the modification of the warrants in October 2024.

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).

NOTE 8 – OPERATING LEASES

On May 27, 2021, the Company entered into a sixty-three month lease for its corporate office at $5,955 per month commencing June 15, 2021 maturing September 30, 2026. The Company accounts for this lease in accordance with ASC 842. Adoption of the standard resulted in the initial recognition of operating lease ROU asset of $290,827 and operating lease liability of $290,827 as of June 15, 2021.

Operating lease right-of-use (“ROU”) assets and liabilities are recognized at commencement date based on the present value of lease payments over the lease term. ROU assets represent our right to use an underlying asset for the lease term and lease liabilities represent our obligation to make lease payments arising from the lease. Generally, the implicit rate of interest in arrangements is not readily determinable and the Company utilizes its incremental borrowing rate in determining the present value of lease payments. The Company’s incremental borrowing rate is a hypothetical rate based on its understanding of what its credit rating would be. The operating lease ROU asset includes any lease payments made and excludes lease incentives. Our variable lease payments primarily consist of maintenance and other operating expenses from our real estate lease. 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.

21On May 15, 2025, the Company entered into a lease termination agreement (“Termination Agreement”) with HGIT Historic Decatur LP to terminate the Company’s San Diego, California office space. The Termination Agreement allows HGIT Historic Decatur LP to retain the security deposit of $20,711 (recorded as operating lease expense) and to be paid $12,000 within twelve (12) months from the termination date. The Company was released from any other obligations.

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:

	2025		2024		2025		2024
	Three Months ended March 31,
	Six Months ended June 30,				Three Months ended June 30,
	2025		2024		2025		2024
Operating lease expense	$	1724,~~919~~751	$	1735,~~919~~838	$	6,832	$	17,919
Short term lease cost	$	-	$	-	$	-	$	-
Total lease expense	$	1724,~~919~~751	$	1735,~~919~~838	$	6,832	$	17,919

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

Three Months ended March 31,	2025			2024
Six Months ended June 30,	2025			2024
Operating cash flows from operating leases	$	1932,~~522~~537		$	1838,~~954~~097
Cash paid for amounts included in the measurement of lease liabilities	$	1932,~~522~~537		$	1838,~~954~~097
Weighted-average remaining lease term—operating leases		~~1.42~~no years			2.422 years
Weighted-average discount rate—operating leases		10	%		10	%

InOperating ~~accordance~~lease ~~with~~cost ~~ASC~~was ~~842~~$6,832 ~~maturities~~and of$24,751, ~~operating~~and ~~lease~~$17,919 ~~liabilities~~and as$35,838 offor ~~March~~the 31three and six months ended June 30, 2025 ~~were~~and as2024, ~~follows:~~respectively.

~~SCHEDULE OF MATURITIES OF OPERATING LEASE LIABILITIES~~22

	Operating
Year ending:	Lease
2025 (9 months)	$	59,934
2026		54,225
Total undiscounted cash flows	$	114,159
Reconciliation of lease liabilities:
Weighted-average remaining lease terms		1.42 years
Weighted-average discount rate		10	%
Present values	$	109,800
Lease liabilities—current		72,300
Lease liabilities—long-term		37,501
Lease liabilities—total	$	109,800
Difference between undiscounted and discounted cash flows	$	4,358

Operating lease cost was $17,919 and $17,919 for the three months ended March 31, 2025 and 2024, respectively.

NOTE 9 – RELATED PARTY TRANSACTIONS

Other than as set forth below, and as disclosed in Note 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,~~748~~750 (of which $8049,~~604~~075 was paid and $3364,~~144~~675 is unpaid and accrued) and $227,500 (of which $129,681 was paid and $97,819 is unpaid and accrued) and $113,~~748~~750 (of which $0 was paid and $113,~~748~~750 is unpaid and accrued), and ~~employee~~$227,500 ~~benefits~~ (of which $~~12,183~~0 was paid and $10227,~~718~~500 is unpaid and accrued), for the three and six months ended ~~March~~June 3130, 2025 and 2024, respectively.

22On 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 $79,658 (of which $0 was paid and $79,658 is unpaid and accrued) and $159,135 (of which $39,784 was paid and $119,351 is unpaid and accrued), and $77,250 (of which $12,875 was paid and $64,375 is unpaid and accrued) and $154,500 (of which $25,750 was paid and $128,750 is unpaid and accrued) for the three and six months ended June 30, 2025 and 2024, respectively.

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 $79,566 (of which $39,782 was paid and $39,784 is unpaid and accrued) and $77,250 (of which $12,875 was paid and $64,375 is unpaid and accrued) for the three months ended March 31, 2025 and 2024, 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

	2025		2024		2025		2024
	For the Three Months Ended March 31,
	For the Six Months Ended June 30,				For the Three Months Ended June 30,
	2025		2024		2025		2024
Convertible notes payable		~~611~~1,~~034~~244,852		~~411~~391,~~430~~659		1,244,852		297,249
Preferred stock		~~301~~641,~~900~~577		~~161~~301,~~673~~900		641,577		301,900
Restricted stock units		6581,~~580~~456		2524,~~307~~848		81,456		12,424
Warrants to purchase shares of common stock		1534,~~483~~225		~~124~~164,~~159~~740		34,225		164,740
Total potentially dilutive shares		~~993~~2,~~998~~002,110		~~722~~883,~~569~~147		2,002,110		776,313

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

	2025			2024			2025			2024
	Three Months Ended March 31,
	Six Months Ended June 30,						Three Months Ended June 30,
	2025			2024			2025			2024
Net loss attributable to the common stockholders	$	(~~668~~2,~~564~~119,751	)	$	(~~758~~1,~~088~~620,471	)	$	(1,451,187	)	$	(862,383	)
Basic weighted average outstanding shares of common stock		1,605,377			1,~~230~~234,~~354~~241			1,605,377			1,238,085
Dilutive effect of options and warrants		-			-			-			-
Diluted weighted average common stock and common stock equivalents		1,605,377			1,~~230~~234,~~354~~241			1,605,377			1,238,085
Loss per share:
Basic and diluted	$	(01.4232	)	$	(01.6231	)	$	(0.90	)	$	(0.70	)

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 January 11, 2025 and October 10, 2022, the Company’s Board of Directors appointed Mr. Michael Ryan and Ms. Richa Nand, Mr. Jim Dorst, and Mr. Chris Wetzel, respectively, 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 ~~March~~June 3130, 2025 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 ~~March~~June 3130, 2025, except for the following:

~~In April 2025, the Company entered into Original Issue Discount Senior~~ Convertible ~~Debentures (“Notes”) totaling (i) $33,000 aggregate~~ ~~principal amount of~~ Notes (total of $30,000 cash was received) due in April 2026 based on $1.00 for each $0.90909 paid by the noteholders and (ii) five-year 5 Common Stock Purchase Warrants (“Warrants”) to purchase up to an aggregate of 8,250 shares of the Company’s Common Stock at an exercise price of $6.00 per share. The aggregate cash subscription amount received by the Company for the issuance of the Note and Warrants was $30,000 which was issued at a $3,000 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.Payable

OnSubsequent to ~~May~~June 1530, 2025, the Company entered into aOriginal ~~lease termination~~Issue ~~agreement~~Discount Senior Convertible Debentures (“~~Termination Agreement~~Notes”) ~~with~~totaling ~~HGIT~~(i) $35,200 ~~Historic~~aggregate ~~Decatur~~principal LPamount of Notes (total of $32,000 cash was received) due in July 2026 based on $1.00 for each $0.90909 paid by the noteholders and (ii) 5 five-year Common Stock Purchase Warrants (“Warrants”) to ~~terminate~~purchase up to an aggregate of 17,600 shares of the Company’s ~~San~~Common ~~Diego, California~~Stock ~~office~~at ~~space~~an exercise price of $4.00 per share. The ~~Termination~~aggregate ~~Agreement~~cash ~~allows~~subscription ~~HGIT~~amount ~~Historic~~received ~~Decatur~~by LPthe toCompany ~~retain~~for the ~~security~~issuance ~~deposit~~ of ~~$20,711~~the Note and toWarrants ~~be paid~~was $1232,000 which ~~within~~was ~~twelve~~issued ~~(12)~~at ~~months~~a $3,200 original issue discount from the ~~termination~~face ~~date~~value of the Note. The ~~Company~~conversion ~~was~~price ~~released~~for ~~from~~the ~~any~~principal ~~other~~in ~~obligations~~connection with voluntary conversions by a holder of the convertible notes is $2.00 per share, subject to adjustment as provided therein, such as stock splits and stock dividends.

~~ITEM~~On August 28, 2025, Sigyn Therapeutics, Inc. ~~MANAGEMENT~~(the “Company”) entered into a Convertible Note Purchase Agreement (the “Purchase Agreement”) with Lambda Venture Partners, LLC, pursuant to which the Company may issue and sell, subject to the terms of the Purchase Agreement, up to $550,000 in aggregate principal amount of 1 one-year 8% convertible promissory notes (the “Notes”) in exchange for $500,000. The Notes are convertible, at the option of the holder, into shares of the Company’Ss ~~DISCUSSION~~common ~~AND~~stock ~~ANALYSIS~~at OFa ~~FINANCIAL~~conversion ~~CONDITION~~price ~~AND~~equal to ~~RESULTS~~a OF35% ~~OPERATIONS~~discount to the lowest traded price of the Company’s common shares during the ten (10) trading days immediately prior to the date on the notice of conversion. The issuances of the foregoing securities are exempt from registration pursuant to Section 4(a)(2) of the Securities Act promulgated thereunder as the Sellers are sophisticated investors and familiar with the Company’s operations. No stock purchase warrants were issued as part of the agreement.

~~You~~On August ~~should~~11, ~~read~~2025, the ~~following~~Company ~~discussion~~issued ofthe ~~our financial~~first ~~condition~~tranche ~~and results~~ of ~~operations~~Notes in ~~conjunction with our financial statements and~~ the ~~notes~~aggregate ~~included~~principal ~~elsewhere~~amount inof ~~this~~$110,000 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~~Lambda ~~differences~~Venture ~~include those~~Partners, ~~discussed~~LLC, ~~below~~ and ~~elsewhere~~received $100,000 in ~~this Form 10-Q and our Annual Report on Form 10-K for the year ended December 31~~proceeds, ~~2024~~consistent ~~particularly~~with ~~under~~ the ~~“Risk~~Purchase ~~Factors” and “Cautionary Note Regarding Forward-Looking Statements and Risk Factors Summary” sections~~Agreement.

~~Our~~Board of ~~Company~~Directors and Officer Resignations

~~Sigyn~~On ~~Therapeutics,~~July ~~Inc. (“Sigyn”~~31, ~~the “Company”,~~2025 ~~“we,”~~Dr. ~~“us,”~~Annette orMarleau ~~“our”)~~resigned isas aChief ~~development-stage~~Scientific ~~company focused on creating therapeutic~~Officer ~~solutions~~of ~~that~~the ~~address unmet needs in global healthcare~~Company. ~~Our corporate address is 2468 Historic Decatur Road, Suite 140, San Diego, California, 92106.~~

~~Sigyn~~On August ~~Therapy™~~8, ~~our~~2025, ~~lead~~Richa ~~product~~Nand ~~candidate, is~~and aMichael ~~broad-spectrum~~Ryan ~~blood~~notified ~~purification~~the ~~technology~~Company ~~designed~~of totheir ~~treat~~decision ~~pathogen-associated~~to ~~inflammatory~~resign ~~disorders~~from ~~that~~the ~~are~~Company’s ~~not~~Board ~~addressed~~of Directors, ~~with~~effective ~~approved~~August ~~drug~~8, ~~therapies~~2025. ~~Candidate~~On ~~treatment~~August ~~indications~~7, ~~include~~2025, ~~endotoxemia~~Christopher ~~and~~Wetzel ~~inflammation~~notified inthe ~~end-stage~~Company ~~renal~~of ~~disease~~his ~~(dialysis) patients,~~decision ~~sepsis~~to (aresign ~~leading~~from ~~cause~~the Board of ~~hospital~~Directors, effective ~~deaths)~~August 7, ~~community~~2025. ~~acquired~~The ~~pneumonia~~resignations (awere ~~leading~~based ~~cause~~on ofthe ~~death~~Company’s ~~among~~discontinuation ~~infectious~~of ~~diseases),~~ directors’ and ~~emerging~~officers’ liability ~~pandemic~~insurance ~~threats~~coverage which expired on August 4, 2025.

~~Our development pipeline includes a cancer treatment~~Extension ~~system comprised~~ of ~~ChemoPrep™ to enhance the tumor site delivery of chemotherapy, and ChemoPure™ to reduce treatment toxicity and inhibit the spread of cancer metastasis.~~Notes

~~Recent~~On August ~~Developments~~29, 2025, noteholders Osher and Brio agreed to extend all of their outstanding notes to December 31, 2027 for original issue discount totaling $737,786.

~~Reverse Stock Split~~25

~~Effective January 19, 2024, the Board of Directors~~ITEM ~~declared~~2. ~~a one-for-forty reverse stock split to shareholders of record on or before January 31, 2024 of the Company~~MANAGEMENT’sS ~~issued~~DISCUSSION ~~and outstanding~~AND ~~shares~~ANALYSIS ofOF ~~common~~FINANCIAL ~~stock,~~CONDITION ~~outstanding~~AND ~~warrants~~RESULTS ~~and~~OF 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.OPERATIONS

~~Financing~~You should ~~Transactions~~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, 2024 particularly under the “Risk Factors” and “Cautionary Note Regarding Forward-Looking Statements and Risk Factors Summary” sections.

~~Preferred Stock~~Our Company

~~The~~Sigyn Therapeutics, ~~Company~~Inc. ~~has~~(“Sigyn”, 10the “Company”,~~000~~ “we,~~000~~” ~~shares~~“us,” ofor ~~par~~“our”) ~~value~~is ~~$0.0001~~a development-stage ~~preferred~~company ~~stock~~focused ~~authorized,~~on ofcreating ~~which~~therapeutic ~~2,403~~solutions ~~and~~that ~~2,403~~address ~~shares~~unmet ~~preferred~~needs ~~shares~~in ~~are~~global ~~issued~~healthcare. ~~and~~Our ~~outstanding~~corporate ataddress ~~March~~is 312468 Historic Decatur Road, ~~2025~~Suite ~~and~~140, ~~December~~San Diego, ~~31,~~ ~~2024~~California, ~~respectively~~92106.

OnSigyn Therapy™, ~~April~~our ~~10,~~lead ~~2024~~product candidate, ~~Osher~~is ~~elected~~a tobroad-spectrum ~~exchange~~blood ~~$621,000 of~~purification ~~Notes~~technology ~~for~~designed anto ~~aggregate~~treat ofpathogen-associated ~~823.86~~inflammatory disorders ~~shares~~that ofare ~~Series~~not Baddressed ~~Convertible~~with ~~Preferred~~approved ~~Stock~~drug therapies. ~~Each~~Candidate ~~Series~~treatment Bindications ~~Convertible~~include ~~Preferred~~endotoxemia ~~Share~~and ~~converts~~inflammation in ~~into~~end-stage ~~125.63~~renal ~~shares~~disease of(dialysis) ~~the Company’s common stock~~patients, ~~subject~~sepsis to(a ~~antidilution~~leading ~~adjustments~~cause ~~for~~of ~~any~~hospital ~~stock~~deaths), ~~splits~~community ~~and~~acquired ~~recapitalizations, and~~pneumonia ~~for~~(a ~~issuances~~leading cause of ~~additional~~death ~~shares~~among atinfectious andiseases), ~~issue~~and ~~price~~emerging ofpandemic ~~less than the conversion ratio~~threats.

~~On April 9, 2024, Brio elected to exchange $220,420~~Our ofdevelopment ~~Notes~~pipeline ~~for~~includes ana ~~aggregate~~cancer oftreatment ~~292.4~~system ~~shares~~comprised of ~~Series~~ChemoPrep™ Bto ~~Convertible~~enhance ~~Preferred~~the ~~Stock.~~tumor ~~Each~~site ~~Series~~delivery ~~B Convertible Preferred Share converts into 125.63 shares~~ of ~~the Company’s common stock~~chemotherapy, and ~~subject~~ChemoPure™ to ~~antidilution~~reduce ~~adjustments~~treatment ~~for~~toxicity ~~any stock splits~~ and ~~recapitalizations, and~~inhibit ~~for~~the ~~issuances~~spread of ~~additional~~cancer ~~shares at an issue price of less than the conversion ratio~~metastasis.

25Recent Developments

~~Common~~ Reverse Stock Split

OnEffective January ~~December 30~~19, 2024, the ~~Company~~Board ~~filed~~of Directors declared a ~~Certificate of~~one-for-forty ~~Amendment~~reverse stock split to ~~our~~shareholders ~~Amended~~of ~~and~~record ~~Restated~~on ~~Certificate~~or ofbefore ~~Incorporation~~January 31, ~~with~~2024 of the ~~State~~Company’s issued and outstanding shares of ~~Delaware~~common stock, ~~which~~outstanding ~~went~~warrants ~~effective~~and ~~immediately~~options, ~~upon~~and the Series B Convertible ~~filing~~Preferred Stock. The ~~Certificate~~number of ~~Amendment~~shares ~~decreased~~of ~~our authorized~~ common stock toand ~~One~~convertible ~~Hundred~~preferred ~~Million~~shares ~~(100,000,000)~~obtainable ~~shares,~~upon ~~par~~exercise ~~value~~or ~~$0.0001, of~~conversion ~~which~~and ~~1,605,377~~the exercise prices and ~~1,605,377~~conversion ~~shares~~rate ~~are~~have ~~outstanding~~been asequitably ofadjusted. ~~March~~As 31such, ~~2025~~all share and ~~December~~per ~~31,~~share ~~2024,~~amounts ~~respectively~~have been retroactively adjusted to reflect the reverse stock split.

~~During the year ended December 31, 2024, the holders~~Financing ~~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.~~Transactions

~~During the year ended December 31, 2024, the Company~~Preferred ~~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.~~Stock

~~Shares~~The Company ~~Cancelled~~has 10,000,000 shares of par value $0.0001 preferred stock authorized, of which 5,107 and 2,403 shares preferred shares are issued and outstanding at June 30, 2025 and December, 31, 2024, respectively.

On June ~~January~~5, 92025, ~~2024~~as a means to induce further investment from established or candidate shareholders, the Company’s ~~CTO~~issued ~~agreed~~four (4) Series toB ~~surrender~~preferred 64shares for each $5,~~100~~000 ~~common~~of shares ~~held~~previously converted by ~~him~~a ~~and~~Convertible ~~were~~Debenture ~~cancelled~~noteholder. byThe Company recorded a total inducement of 2,704 Series B preferred shares, valued at $845,901 (based on the ~~Company~~estimated fair value of the stock on the date of grant) in the unaudited condensed consolidated Statements of Operations.

~~Restricted~~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 ~~Units~~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.

~~Warrants~~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.

~~On August 24, 2024, the Company issued 3,325 warrants~~Common ~~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.~~Stock

InOn December ~~accordance~~30, ~~with ASC 718-20~~2024, ~~Compensation~~the ~~– Stock~~Company ~~Compensation,~~filed a ~~modification~~Certificate of aAmendment ~~stock~~to ~~award~~our isAmended ~~treated~~and asRestated anCertificate ~~exchange~~ of ~~the~~Incorporation ~~original~~with ~~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~~State of ~~the~~Delaware, ~~fair~~which ~~value~~went ofeffective ~~the~~immediately ~~modified~~upon ~~award~~filing. ~~over~~The ~~the~~Certificate ~~fair value~~ of ~~the~~Amendment ~~original~~decreased ~~award~~our ~~immediately~~authorized ~~before~~common ~~its~~stock ~~terms~~to ~~are~~One Hundred ~~modified~~Million ~~and~~(100,000,000) ~~recognized over~~shares, ~~the~~par ~~vesting~~value ~~period~~$0.0001, Aof ~~short-term~~which ~~inducement~~1,605,377 ~~shall~~and be1,605,377 ~~accounted~~shares ~~for~~are outstanding as ~~a modification~~ of ~~the~~June ~~terms~~30, of2025 and ~~only~~December ~~those~~31, ~~that~~2024, ~~accept the inducement~~respectively.

OnDuring the ~~October~~year 8ended December 31, 2024, the ~~Company offered a short-term inducement to the Company’s warrant~~ holders inof ~~which~~$707,730 ~~the~~of ~~Company~~Original ~~will~~Issue ~~issue~~Discount ¾Senior ofConvertible aDebentures ~~share~~converted oftheir ~~the Company’s common stock~~debentures in exchange for ~~each~~the ~~warrant.~~issuance Inof ~~response to this offer~~157,526 ~~246,257 warrants were exchanged for 184,700~~ shares of ~~the~~Common ~~Company’s~~Stock ~~common stock. The Company recognized a gain of $63,715 due~~ to the ~~modification of the warrants in October 2024~~holders.

OnDuring the ~~September~~year 5ended December 31, 2024, the Company ~~entered~~issued ~~into~~38,325 ~~the 2024~~common ~~Notes~~shares ~~that~~valued ~~included warrants~~ at ~~an exercise price of~~ $~~7.50~~214,550 (~~see~~based ~~Note~~on 5)the ~~resulting~~estimated infair avalue ~~modification~~ of the ~~warrants valued at $24,770~~ ~~(based~~stock on the ~~Black~~date ~~Scholes~~of ~~options~~grant), ~~pricing~~respectively, ~~method~~for onservices ~~the modification date)~~rendered.

~~Promissory Notes~~Shares Cancelled

On January ~~November 26~~9, 2024, the Company’s ~~entered~~CTO ~~into~~agreed ~~promissory notes~~to ~~totaling~~surrender ~~$314~~64,~~000~~100 ~~aggregate~~common ~~principal~~shares ~~amount~~held ~~of promissory notes (total of $157,000 cash was received) due November 26, 2025 based on $1.00 for each $0.50 paid~~ by ~~the~~him ~~noteholders~~and ~~which~~ were ~~issued~~cancelled atby ~~a $157,000 original issue discount from~~ the ~~face value of the promissory notes~~Company.

26Restricted Stock Units

~~Regulation~~Effective January D11, 2025 and October 10, 2022, the Company’s Board of Directors appointed Mr. Michael Ryan and Ms. Richa Nand, Mr. Jim Dorst, and Mr. Chris Wetzel, respectively, as non-executive members to the Company’s Board of Directors (“Director”). Effective January 1, 2023, each Director shall receive an annual grant of restricted stock units of $50,000. During the three and six months ended June 30, 2025 and 2024, respectively, the Company recorded stock-based compensation totaling $50,000 and $100,000, and $37,500 and $75,000, respectively, in the unaudited condensed consolidated Statements of Operations.

On January 9, 2025, the Company initiated a Regulation D offering to sell up to 750,000 Units at a price of $5,000 per unit with each Unit consisting of one (1) $5,500 principal amount convertible debenture (convertible at Four dollars ($4.00) per share into the Company’s common stock) and a Warrant to purchase 1,250 shares of common stock at $6.00 per share. The Debentures have a principal amount equal to 110% of such Purchaser’s subscription amount, convertible at $4.00 per share and maturing one (1) year from the date the subscription amount is accepted by the Company. The Warrants for a number of shares equal to the subscription amount divided by the conversion price with an exercise price of $6.00 per share, exercisable upon issuance and will expire five years from issuance. The Debentures will not be redeemable but contain an automatic conversion feature, which will cause all principal and interest due under the Debenture to automatically convert if our common stock is listed for trading on a national securities exchange, such as NASDAQ or the NYSE. As of March 31, 2025, a total of 69 Units were sold to accredited investors at a price of $5,500 per Unit totaling $379,717 (total of $295,197 cash was received and $50,000 as a subscription receivable).

~~Convertible~~On June ~~Notes~~5, 2025, as a means to induce further investment from established shareholders, the Company adjusted the conversion price of the Company’s outstanding warrants from $6.00 per share to $4.00 per share. The Company recognized a loss of $17,505 due to the modification of the warrants in June 2025 in the unaudited condensed consolidated Statements of Operations.

~~Between~~On August ~~January~~24, ~~2020 and November~~ 2024, the Company ~~received~~ ~~cash~~issued ~~of $4~~3,~~849,885~~325 ~~through~~warrants ~~the~~valued ~~issuance~~at ~~of 10% Original Issue Discount Senior Convertible Debentures with third party investors. Between June 2023 and September 2024,~~ $315,~~069,348~~703 in(based ~~aggregate~~on ~~principal amount of~~ the ~~notes~~fair ~~were~~value ~~converted into 371,110 common shares and 1,116.29 shares~~ of ~~Series B Convertible Preferred Stock. Each share of Series B Convertible Preferred Stock converts into 125.63 shares of~~ the ~~Company’s~~options ~~common~~using ~~stock, subject to antidilution adjustments for any stock splits and recapitalizations, and for~~ the ~~issuances~~Black-Scholes ofoption-pricing ~~additional~~method ~~shares~~on atthe andate ~~issue price~~ of ~~less~~grant), ~~than~~for ~~the~~services ~~conversion ratio~~rendered.

~~The~~In accordance ~~remaining~~with ~~outstanding~~ASC ~~Notes~~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 ~~follows:~~a modification of the terms of only those that accept the inducement.

Note Holder/Original Issuance Date	Maturity Date	Cash Received		Outstanding Balance as of March 31, 2025 (1)		Outstanding Balance as of December 31, 2024 (1)
Osher Capital Partners LLC
January 28, 2020 (“Note 1”)	August 31, 2025	$	350,005	$	620,553	$	620,553
June 22, 2022 (“Note 2”)	August 31, 2025		75,000		103,745		103,745
August 31, 2022 (“Note 2”)	August 31, 2025		100,000		135,520		135,520
September 20, 2022 (“Note 2”)	August 31, 2025		100,000		135,520		135,520
October 20, 2022 (“Note 2”)	March 31, 2025		100,000		127,000		127,000
November 14, 2022 (“Note 2”)	March 31, 2025		50,000		64,350		64,350
December 22, 2022 (“Note 2”)	March 31, 2025		100,000		125,000		125,000
July 18, 2023 (“Note 3”)	August 31, 2025		60,000		72,600		72,600
December 7, 2023 (“Note 3”)	August 31, 2025		40,000		48,400		48,400
May 13, 2024 (“Note 4”)	May 13, 2025		35,000		40,000		40,000
August 19, 2024 (“Note 4”)	August 19, 2025		7,500		8,250		8,250
November 19, 2024 (“Note 4”)	November 19, 2025		8,000		8,800		8,800
Brio Capital Master Fund, Ltd.
March 23, 2022 (“Note 2”)	August 31, 2025		100,000		142,960		142,960
November 9, 2022 (“Note 2”)	August 31, 2025		75,000		101,640		101,640
January 20, 2023 (“Note 3”)	March 31, 2025		50,000		62,500		62,500
February 9, 2023 (“Note 3”)	March 31, 2025		50,000		62,500		62,500
July 20, 2023 (“Note 3”)	August 31, 2025		40,000		48,400		48,400
January 8, 2024 (“Note 4”)	January 8, 2025		40,000		44,000		44,000
May 13, 2024 (“Note 4”)	May 13, 2025		35,000		40,000		40,000
August 20, 2024 (“Note 4”)	August 20, 2025		11,500		12,650		12,650
November 19, 2024 (“Note 4”)	November 19, 2025		8,000		8,800		8,800
Various third-party noteholders
Various dates in fiscal 2024 (“Note 4”)	November 19, 2025		650,890		8,800		8,800
FY 2025 Regulation D	Primarily January 9, 2026		345,197		379,717		-
Total convertible notes payable		$	2,431,092	$	2,401,705	$	2,021,988

~~(1) includes amounts for original issue discounts and implied interest for subsequent note extensions at between 10% and 12%.~~27

27On 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).

~~The outstanding Osher and Brio Notes can convert into~~Promissory a total of 4,092 shares of Series B Convertible Preferred Stock, with each share of Series B Convertible Preferred Stock convertible into 125.63 shares of the Company’s common stock, subject to adjustment as provided therein, such as stock splits and stock dividends. In addition, the remaining Notes provide for an automatic conversion into Series B Convertible Preferred Stock in accordance with their terms upon a listing of the Company’s common stock on a national securities exchange such as Nasdaq Capital Market.

~~The Company~~On ~~has~~June ~~not~~9, ~~repaid~~2025, ~~three~~the ~~Osher~~Company ~~convertible~~entered ~~notes~~into ~~totaling~~a ~~$316,350~~promissory ~~that~~note ~~matured~~of on$10,000 ~~March~~due July 31, 2025 and ~~the convertible notes are now in default. The Company~~ is ~~currently~~non-interest ~~in discussions to restructure the terms of these notes~~bearing.

~~The Company~~On ~~has~~November ~~not~~26, ~~repaid~~2024, ~~two~~the ~~Brio~~Company ~~convertible~~entered into promissory notes totaling $~~125~~314,000 ~~that~~aggregate ~~matured~~principal onamount ~~March~~of 31promissory notes (total of $157,000 ~~2025~~cash ~~and~~was ~~the~~received) ~~convertible~~due ~~notes~~November ~~are~~26, ~~now~~2025 inbased ~~default~~on $1. ~~The~~00 ~~Company~~for iseach ~~currently~~$0.50 inpaid ~~discussions~~by tothe ~~restructure~~noteholders which were issued at a $157,000 original issue discount from the ~~terms~~face value of ~~these~~the promissory notes.

~~The Company~~Regulation ~~has~~D not repaid the Brio January 8, 2024 convertible note of $44,000 that matured on January 8, 2025 and the convertible note is now in default. The Company is currently in discussions to restructure the terms of the note.

~~Limited~~On January ~~Operating~~9, ~~History;~~2025, ~~Need~~the Company initiated a Regulation D offering to sell up to 750,000 Units at a price of $5,000 per unit with each Unit consisting of one (1) $5,500 principal amount convertible debenture (convertible at two dollars ($2.00) per share into the Company’s common stock) and a Warrant to purchase 1,250 shares of common stock at $4.00 per share. The Debentures have a principal amount equal to 110% of such Purchaser’s subscription amount, convertible at $2.00 per share and maturing one (1) year from the date the subscription amount is accepted by the Company. The Warrants for ~~Additional~~a number of shares equal to the subscription amount divided by the conversion price ~~Capital~~with an exercise price of $4.00 per share, exercisable upon issuance and will expire five years from issuance. The Debentures will not be redeemable but contain an automatic conversion feature, which will cause all principal and interest due under the Debenture to automatically convert if our common stock is listed for trading on a national securities exchange, such as NASDAQ or the NYSE. As of June 30, 2025, a total of 69 Units were sold to accredited investors at a price of $5,500 per Unit totaling $379,717 (total of $345,197 cash was received).

~~There is limited historical financial information~~Convertible 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.Notes

~~Business~~Between January ~~Overview~~2020 and June 2025, the Company received cash of $4,934,885 through the issuance of 10% Original Issue Discount Senior Convertible Debentures with third party investors. Between June 2023 and September 2024, $3,069,348 in aggregate principal amount of the notes were converted into 371,110 common shares and 1,116.29 shares of Series B Convertible Preferred Stock. Each share of Series B Convertible Preferred Stock converts into 125.63 shares of the Company’s common stock, subject to antidilution adjustments for any stock splits and recapitalizations, and for the issuances of additional shares at an issue price of less than the conversion ratio.

~~Sigyn Therapeutics, Inc. (“Sigyn”, the~~The ~~“Company”~~remaining ~~“we,”~~outstanding ~~“us,”~~Notes 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 ImmunePrepTM platform to enhance the performance of immunotherapeutic antibodies; ChemoPrepTM to improve the delivery of chemotherapy; and ChemoPureTM to reduce chemotherapy toxicity. Our lead therapeutic candidate is Sigyn TherapyTM to address infectious disease disorders that are ~~not~~as ~~treatable with drugs. If successfully advanced, our therapies offer to provide strategic value to the pharmaceutical, dialysis, and organ transplant industry.~~follows:

Infectious Disease Disorders

Note Holder/Original Issuance Date	Maturity Date	Cash Received		Outstanding Balance as of June 30, 2025		Outstanding Balance as of December 31, 2024
Osher Capital Partners LLC
January 28, 2020 (“Note 1”)	August 31, 2025	$	350,005	$	620,553	$	620,553
June 22, 2022 (“Note 2”)	August 31, 2025		75,000		103,745		103,745
August 31, 2022 (“Note 2”)	August 31, 2025		100,000		135,520		135,520
September 20, 2022 (“Note 2”)	August 31, 2025		100,000		135,520		135,520
October 20, 2022 (“Note 2”)	March 31, 2025		100,000		127,000		127,000
November 14, 2022 (“Note 2”)	March 31, 2025		50,000		64,350		64,350
December 22, 2022 (“Note 2”)	March 31, 2025		100,000		125,000		125,000
July 18, 2023 (“Note 3”)	August 31, 2025		60,000		72,600		72,600
December 7, 2023 (“Note 3”)	August 31, 2025		40,000		48,400		48,400
May 13, 2024 (“Note 4”)	May 13, 2025		35,000		40,000		40,000
August 19, 2024 (“Note 4”)	August 19, 2025		7,500		8,250		8,250
November 19, 2024 (“Note 4”)	November 19, 2025		8,000		8,800		8,800
April 15, 2025	April 15, 2026		20,000		22,000		-

Brio Capital Master Fund, Ltd.
March 23, 2022 (“Note 2”)	August 31, 2025		100,000		142,960		142,960
November 9, 2022 (“Note 2”)	August 31, 2025		75,000		101,640		101,640
January 20, 2023 (“Note 3”)	March 31, 2025		50,000		62,500		62,500
February 9, 2023 (“Note 3”)	March 31, 2025		50,000		62,500		62,500
July 20, 2023 (“Note 3”)	August 31, 2025		40,000		48,400		48,400
January 8, 2024 (“Note 4”)	January 8, 2025		40,000		44,000		44,000
May 13, 2024 (“Note 4”)	May 13, 2025		35,000		40,000		40,000
August 20, 2024 (“Note 4”)	August 20, 2025		11,500		12,650		12,650
November 19, 2024 (“Note 4”)	November 19, 2025		8,000		8,800		8,800
April 23, 2025	April 23, 2026		10,000		11,000		-

Various third-party noteholders
Various dates in fiscal 2024 (“Note 4”)	November 19, 2025		650,890		8,800		8,800
Various dates in fiscal 2025 (“Note 5”)	Through June 2026		50,000		55,000		-
FY 2025 Regulation D	Primarily January 9, 2026		345,197		379,717		-
Total convertible notes payable		$	2,511,092	$	2,489,705	$	2,021,988

~~To address infectious disease disorders that are not~~(1) ~~treatable~~includes ~~with~~amounts ~~drugs,~~for weoriginal ~~designed~~issue ~~Sigyn~~discounts ~~TherapyTM to extract deadly pathogens~~ and ~~toxins~~implied ~~from~~interest afor ~~patient’s~~subsequent ~~bloodstream, while~~note ~~simultaneously~~extensions ~~providing~~at abetween ~~mechanism~~10% to dampen down excessive immune responses that are associated with life-threatening infections. Sigyn TherapyTM has been validated to extract viral pathogens, bacterial toxins (including endotoxin), hepatic toxins and ~~inflammatory cytokines from human blood plasma~~12%. ~~These expansive capabilities establish Sigyn TherapyTM as 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)28

28The outstanding Osher and Brio Notes can convert into a total of 4,153 shares of Series B Convertible Preferred Stock, with each share of Series B Convertible Preferred Stock convertible into 125.63 shares of the Company’s common stock, subject to adjustment as provided therein, such as stock splits and stock dividends. In addition, the remaining Notes provide for an automatic conversion into Series B Convertible Preferred Stock in accordance with their terms upon a listing of the Company’s common stock on a national securities exchange such as Nasdaq Capital Market.

~~Previous~~Extension of ~~Infectious Disease Industry Achievements~~Notes

~~We have relevant experience in developing blood purification~~On ~~technologies~~August to29, ~~treat~~2025, ~~infectious~~noteholders ~~disease~~Osher 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~~Brio ~~first~~agreed to ~~receive~~extend ~~two~~all ~~“Breakthrough Device” designation awards from FDA. As a result~~ of ~~these~~their ~~achievements,~~outstanding ~~TIME~~notes ~~Magazine named the device~~ to ~~its~~December ~~list~~31, of2027 ~~“Top~~for ~~Inventions”~~original ~~and~~issue ~~“Top~~discount totaling ~~Medical Breakthroughs~~$737,786.”

~~Sigyn TherapyTM Human Studies~~ Lease Termination

~~First-in-human~~On May ~~clinical~~15, ~~studies~~2025, ofthe ~~Sigyn~~Company ~~TherapyTM plan~~entered tointo ~~enroll~~a ~~end-stage~~lease ~~renal~~termination ~~disease~~agreement (~~ESRD~~“Termination Agreement”) ~~subjects~~ with ~~endotoxemia~~HGIT ~~and~~Historic ~~concurrent inflammation, which are prevalent, yet untreatable~~Decatur ~~conditions~~LP ~~that~~to ~~shorten~~terminate the ~~lives~~Company’s ofSan ~~dialysis patients. Approximately 550~~Diego,~~000~~ ~~individuals~~California ~~suffer~~office ~~from~~space. ~~ESRD~~The inTermination ~~the~~Agreement ~~United~~allows ~~States.~~HGIT AHistoric ~~therapeutic strategy~~Decatur ~~that~~LP ~~helped~~ to retain ~~extend~~ the ~~lives~~security deposit of ~~ESRD patients may have quantifiable value to the dialysis industry~~$20,711 ~~which~~(recorded isas ~~dominated~~operating ~~by Fresenius~~lease ~~Medical~~expense) ~~Care~~ and ~~DaVita,~~to ~~Inc.~~be inpaid ~~North~~$12,000 ~~America.~~within ~~Based~~twelve on(12) ~~the~~months ~~number~~from ~~of ESRD patients treated in their networks, every month~~the oftermination ~~extended~~date. ~~life~~The ~~would~~Company ~~equate~~was toreleased ~~approximately~~from $1any ~~billion~~other ~~in added revenues for each company~~obligations.

~~Emerging~~Limited Operating ~~Opportunity~~History; inNeed ~~Xenotransplantation~~for Additional Capital

~~Beyond the post-exposure treatment of infectious disease~~There ~~disorders,~~is ~~Sigyn~~limited ~~TherapyTM~~historical ~~offers~~financial ainformation ~~potential~~about ~~preventative~~us ~~strategy~~on which to ~~reduce~~base ~~the~~an ~~spread~~evaluation of ~~infection~~our inperformance. ~~organ~~We ~~transplantations, including~~cannot ~~xenotransplantation,~~guarantee anwe ~~emerging~~will ~~field~~be successful ~~related~~in toour ~~the~~business ~~transplantation~~operations. ofOur anbusiness ~~organ~~is ~~from~~subject ato ~~donor~~risks ~~animal~~inherent ~~species~~in ~~into~~the aestablishment ~~human recipient. The advancement~~ of ~~xenotransplantation is being fueled by~~ a ~~global~~new ~~shortage~~business ofenterprise, ~~transplantable~~including limited ~~human~~capital ~~organs~~resources, and ~~the~~possible ~~recent~~cost ~~emergence~~overruns ~~of gene-editing~~due ~~technologies~~to ~~that~~increases ~~have~~in ~~increased~~ the ~~compatibility~~cost of ~~porcine-derived~~services. ~~(pig)~~To ~~kidneys~~become ~~for~~profitable ~~human~~and ~~transplantation.~~competitive, we Inmust ~~the~~receive ~~United States,~~additional ~~approximately~~capital. ~~90,000~~We ~~individuals~~have ~~are~~no onassurance ~~the~~that ~~waitlist~~future ~~for~~financing awill ~~kidney~~materialize. ~~transplant,~~If ~~yet~~that ~~fewer~~financing ~~than~~is 30not available,~~000~~ we ~~kidney~~may ~~transplants~~be ~~are~~unable ~~performed each~~to ~~year~~continue operations.

~~To optimize xenotransplantation outcomes, Sigyn TherapyTM~~Business ~~is proposed for administration to:~~Overview

	1.	Gene-edited donor pigs to reduce pathogen accumulation in donor kidneys prior to their extraction for human transplantation. The feasibility of Sigyn TherapyTM administration has been demonstrated in eight (8) porcine subjects to date.
	2.	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.

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^TM platform 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 to address infectious disease disorders that are not treatable with drugs. If successfully advanced, our therapies offer to provide strategic value to the pharmaceutical, dialysis, and organ transplant industry.

~~This use of Sigyn TherapyTM in these applications~~Infectious ~~corresponds~~Disease ~~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.~~Disorders

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

We1. ~~are~~Untreatable ~~not~~viral apathogens ~~developer~~(most of ~~drugs~~the to200+ ~~treat~~viruses ~~cancer.~~that ~~We are~~infect ahumans ~~developer~~are ofnot ~~medical~~treatable ~~devices~~with ~~to optimize the benefit of~~ drugs) to2. ~~treat~~Antibiotic-resistant ~~cancer,~~bacterial ~~the~~infections ~~2nd~~(an ~~leading~~increasingly ~~cause~~prevalent ofglobal ~~death~~health inthreat) ~~the United States~~3. ~~Our~~Endotoxemia ~~therapeutic~~(bacterial ~~candidates~~toxin ~~include~~whose ~~the~~bloodstream ~~ImmunePrepTM~~presence ~~platform~~commonly toinduces ~~enhance~~sepsis) ~~the~~4. ~~performance~~Sepsis of(leading ~~immunotherapeutic antibodies,~~cause ~~ChemoPrepTM to improve the delivery~~ of ~~chemotherapy,~~hospital ~~and~~deaths ~~ChemoPureTM~~in ~~to extract off-target chemotherapy from~~ the ~~bloodstream~~United ~~to reduce treatment toxicity.~~States)

29Previous Infectious Disease Industry Achievements

~~ImmunePrepTM~~We have relevant experience in developing blood purification technologies to ~~Optimize~~treat ~~Immunotherapeutic~~infectious disease disorders. Most members of our team ~~Antibodies~~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.”

~~Immunotherapeutic antibodies (monoclonal antibodies,~~Sigyn ~~therapeutic~~TherapyTM ~~antibodies,~~Human ~~checkpoint~~Studies 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.

InFirst-in-human clinical ~~response,~~studies weof ~~invented~~Sigyn ~~the~~TherapyTM ~~ImmunePrepTM platform~~plan to ~~allow~~enroll ~~for~~end-stage arenal ~~therapeutic~~disease ~~antibody~~(ESRD) tosubjects bewith ~~immobilized~~endotoxemia ~~within~~and anconcurrent inflammation, ~~extracorporeal~~which ~~circuit~~are toprevalent, ~~sweep~~yet ~~antibody~~untreatable ~~decoys~~conditions ~~out~~that ofshorten the ~~bloodstream prior~~lives ~~to the subsequent infusion~~ of ~~the~~dialysis ~~antibody~~patients. toApproximately a550,000 ~~patient.~~individuals suffer Wefrom ~~believe~~ESRD ~~this~~in ~~reverse~~the ~~decoy~~United ~~mechanism~~States. ~~will~~A ~~improve~~therapeutic ~~targeted~~strategy ~~antibody delivery~~that ~~and~~helped ~~simultaneously~~to ~~reduce~~extend the ~~circulating~~lives ~~presence~~ of ~~the~~ESRD ~~antibody’s~~patients ~~cancer~~may ~~targets~~have quantifiable value to ~~further~~the ~~enhance~~dialysis ~~patient~~industry, ~~benefit. As~~which ais ~~platform~~dominated ~~technology,~~by ~~ImmunePrepTM~~Fresenius ~~allows~~Medical ~~for~~Care ~~the~~and ~~potential~~DaVita, ~~development~~Inc. ofin ~~products~~North ~~that~~America. ~~may~~Based ~~incorporate~~on athe ~~development-stage,~~number of ~~clinical-stage~~ESRD orpatients ~~market-approved~~treated ~~antibody.~~in ~~Based~~their ~~on previous FDA interactions~~networks, weevery ~~believe~~month ~~ImmunePrepTM~~of ~~products~~extended ~~that~~life ~~incorporate market-approved~~would ~~antibodies~~equate ~~may~~to ~~have~~approximately an$1 ~~accelerated~~billion ~~pathway~~in toadded ~~potential~~revenues ~~market~~for each ~~clearance~~company.

~~ChemoPrepTM~~Emerging Opportunity toin ~~Optimize Chemotherapy Delivery~~Xenotransplantation

~~Chemotherapeutic~~Beyond the ~~agents~~post-exposure ~~are~~treatment ~~the~~of ~~most~~infectious ~~commonly~~disease ~~administered class~~disorders, ofSigyn ~~drug~~TherapyTM tooffers ~~treat~~a ~~cancer,~~potential ~~yet~~preventative ~~only~~strategy ato ~~small~~reduce the ~~fraction~~spread of ~~infused~~infection ~~doses~~in ~~reach~~organ ~~their~~transplantations, ~~cancer~~including ~~cell~~xenotransplantation, ~~targets.~~an ~~Contributing~~emerging tofield ~~inadequate delivery~~related ~~are~~to ~~high~~the ~~concentrations~~transplantation of an ~~tumor-derived~~organ ~~exosomes,~~from ~~whose~~a ~~bloodstream~~donor ~~presence~~animal ~~disrupts~~species ~~chemotherapy~~into ~~delivery~~a ~~and~~human ~~corresponds with~~recipient. ~~treatment~~The ~~resistance.~~advancement Weof ~~designed~~xenotransplantation ~~ChemoPrepTM~~is tobeing ~~reduce~~fueled ~~the~~by ~~circulating~~a ~~presence~~global shortage of ~~tumor-derived~~transplantable ~~exosomes~~human ~~prior~~organs ~~chemotherapy administration.~~and ~~Our~~the ~~clinical~~recent ~~goal~~emergence isof togene-editing ~~maintain~~technologies orthat ~~improve~~have increased the ~~efficacy~~compatibility of ~~chemotherapy~~porcine-derived (pig) ~~with~~kidneys ~~lower~~for ~~doses,~~human ~~which~~transplantation. ~~would~~In ~~reduce~~the ~~treatment toxicity.~~United InStates, ~~this~~approximately ~~regard~~90,000 ~~ChemoPrepTM~~individuals ~~aligns~~are ~~with~~on the ~~FDA~~waitlist ~~“Project~~for ~~Optimus”~~a ~~initiative~~kidney totransplant, yet ~~minimize~~fewer ~~the~~than ~~toxicity of~~30,000 ~~cancer~~kidney ~~drugs~~transplants ~~while~~are ~~maximizing~~performed ~~patient~~each ~~benefit~~year.

~~ChemoPureTM to Reduce Chemotherapy Toxicity~~29

~~Once~~To optimize ~~chemotherapy~~xenotransplantation ~~has been administered~~outcomes, ~~residual off-target~~Sigyn ~~chemotherapy~~TherapyTM ~~that~~ is ~~left~~proposed tofor ~~circulate~~administration ~~in the bloodstream is more likely~~ to ~~cause patient harm versus benefit. In response, we designed ChemoPureTM to extract off-target chemotherapy from the bloodstream to further reduce treatment toxicity.~~:

About Sigyn Therapy - Our Lead Therapeutic Candidate

	1.	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.

	2.	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.

~~To address infectious disease disorders that are not~~This ~~treatable~~use ~~with~~of ~~drugs, we designed~~ Sigyn TherapyTM toin ~~extract~~these ~~deadly~~applications ~~pathogens~~corresponds ~~and~~with ~~toxins~~published ~~from~~FDA aguidance ~~patient’s~~on ~~bloodstream, while~~the ~~simultaneously~~need ~~providing~~for astrategies ~~mechanism~~ to ~~dampen down excessive immune responses that are associated with life-threatening infections.~~mitigate ~~Sigyn~~the ~~TherapyTM~~risk ~~has~~of ~~been~~a ~~validated~~known toor ~~extract~~unknown ~~viral~~pathogen ~~pathogens,~~being ~~bacterial~~transmitted ~~toxins (including endotoxin), hepatic toxins and inflammatory cytokines~~ from ~~human blood plasma. These expansive capabilities establish Sigyn TherapyTM as~~ a ~~novel~~porcine-derived ~~strategy~~organ to ~~address~~a ~~several unmet~~human ~~needs~~transplant ~~in global health, including untreatable viral pathogens, antibiotic-resistant bacterial infections, endotoxemia, and sepsis~~recipient.

~~Sigyn~~Devices to ~~TherapyTM~~Optimize ~~Pre-Clinical~~the ~~Studies~~Benefit of Cancer Therapies

~~Since~~We are ~~the~~not ~~inception~~a developer of ~~our Company,~~drugs weto ~~have~~treat ~~advanced~~cancer. ~~Sigyn~~We ~~Therapy~~are ~~from~~a ~~conceptual~~developer ~~design through completion~~ of ~~pre-clinical~~medical indevices ~~vitro~~to ~~studies~~optimize ~~that have quantified~~ the ~~reduction~~benefit of ~~relevant~~drugs ~~therapeutic~~to ~~targets~~treat ~~from~~cancer, the ~~human~~2nd ~~blood~~leading ~~plasma~~cause ~~with~~of ~~small-scale~~death ~~versions~~in ofthe ~~Sigyn~~United ~~Therapy~~States. ~~These~~Our ~~include~~therapeutic ~~endotoxin (gram-negative~~candidates ~~bacterial~~include ~~toxin);~~the ~~peptidoglycan~~ImmunePrepTM ~~and~~platform to ~~lipoteichoic~~enhance ~~acid~~the ~~(gram-positive~~performance ~~bacterial~~of ~~toxins);~~immunotherapeutic ~~viral pathogens (including SARS-CoV-2); hepatic toxins (ammonia~~antibodies, ~~bile~~ChemoPrepTM ~~acid,~~to ~~and~~improve ~~bilirubin);~~the ~~and~~delivery ~~tumor~~of ~~necrosis factor alpha (TNF alpha)~~chemotherapy, ~~interleukin-1 beta (IL-1b),~~ and ~~interleukin~~ChemoPureTM 6to ~~(IL-6),~~extract ~~which are pro~~off-~~inflammatory~~target ~~cytokines~~chemotherapy ~~whose~~from ~~dysregulated production (~~the ~~cytokine~~bloodstream ~~storm)~~to ~~precipitate~~reduce ~~sepsis~~treatment ~~and play a prominent role in each of our therapeutic opportunities~~toxicity.

30ImmunePrepTM to Optimize Immunotherapeutic Antibodies

~~Sigyn~~Immunotherapeutic antibodies ~~TherapyTM~~(monoclonal ~~Animal~~antibodies, ~~Studies~~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.

~~Subsequent to our pre-clinical~~In ~~in vitro studies~~response, we ~~disclosed~~invented the ~~completion~~ImmunePrepTM ofplatform into ~~vivo~~allow ~~animal studies. In these studies, Sigyn Therapy was administered via standard dialysis machines utilizing conventional blood-tubing sets,~~ for ~~periods~~a oftherapeutic upantibody to ~~six~~be ~~hours~~immobilized towithin ~~eight~~an ~~(8) porcine (pig) subjects,~~extracorporeal ~~each~~circuit ~~weighing~~to ~~approximately~~sweep ~~40-45~~antibody ~~kilograms.~~decoys ~~The~~out ~~studies were comprised~~ of ~~a pilot phase (two subjects), which evaluated~~ the ~~feasibility of~~bloodstream ~~the~~prior ~~study~~to ~~protocol in~~ the ~~first-in-mammal~~subsequent ~~use~~infusion of ~~Sigyn~~the ~~Therapy;~~antibody ~~and~~to ana ~~expansion~~patient. ~~phase~~We ~~(six~~believe ~~subjects)~~this reverse todecoy ~~further~~mechanism ~~assess~~will ~~treatment~~improve ~~feasibility and~~targeted ~~refine~~antibody ~~pre-treatment~~delivery ~~set-up~~ and ~~operating~~simultaneously ~~procedures.~~reduce ~~There~~the ~~were~~circulating nopresence ~~serious adverse events reported in any~~ of the ~~treated animal subjects.~~antibody’s Ofcancer ~~the~~targets ~~eight~~to ~~treatments,~~further ~~seven~~enhance ~~were~~patient ~~administered for the entire six-hour treatment period~~benefit. ~~One~~As ~~treatment~~a ~~was~~platform ~~halted~~technology, ~~early~~ImmunePrepTM ~~due~~allows tofor the ~~observation~~potential development of aproducts ~~clot~~that inmay ~~the~~incorporate ~~device~~a development-stage, ~~which~~clinical-stage ~~was~~or ~~believed~~market-approved toantibody. beBased ~~the~~on ~~result~~previous ofFDA ainteractions, we ~~procedural~~believe ~~deviation~~ImmunePrepTM inproducts ~~the~~that ~~pre-treatment~~incorporate ~~set~~market-~~up.~~approved ~~Important~~antibodies ~~criteria for~~may ~~treatment~~have ~~feasibility~~an –accelerated ~~including~~pathway ~~hemodynamic~~to ~~parameters, serum chemistries and hematologic measurements – were stable~~potential ~~across~~market ~~all subjects~~clearance.

~~The studies were conducted~~ChemoPrepTM ~~by a clinical team at Innovative BioTherapies, Inc. (“IBT”), under a contract with the University of Michigan~~ to ~~utilize~~Optimize ~~animal care,~~Chemotherapy 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”).Delivery

~~The animal studies were conducted~~Chemotherapeutic toagents ~~correspond~~are ~~with~~the ~~FDA’s~~most ~~best~~commonly ~~practice~~administered ~~guidance.~~class ~~The number~~ of ~~animals~~drug ~~enrolled~~to intreat ~~our~~cancer, ~~study~~yet ~~and~~only ~~the~~a ~~amount~~small fraction of ~~data~~infused ~~collected~~doses ~~was~~reach their cancer ~~based~~cell ontargets. ~~the~~Contributing ~~ethical~~to ~~and~~inadequate ~~least~~delivery ~~burdensome~~are ~~principles~~high ~~that~~concentrations ~~underly~~of ~~the~~tumor-derived ~~FDA~~exosomes, ~~goal~~whose ofbloodstream ~~using~~presence ~~the~~disrupts chemotherapy ~~minimum~~delivery ~~number~~and ofcorresponds ~~animals~~with ~~necessary~~treatment toresistance. ~~generate valid~~We ~~scientific~~designed ~~data~~ChemoPrepTM to ~~demonstrate~~reduce ~~reasonable~~the ~~feasibility~~circulating ~~and performance~~ presence of atumor-derived ~~medical~~exosomes ~~device~~ prior tochemotherapy ~~human study consideration~~administration. ~~A porcine~~Our ~~animal~~clinical ~~model~~goal is ato ~~generally~~maintain ~~accepted~~or ~~model~~improve ~~for~~ the ~~study~~efficacy of ~~extracorporeal~~chemotherapy with ~~blood~~lower ~~purification~~doses, ~~devices~~which ~~intended~~would toreduce ~~treat~~treatment ~~infectious disease~~toxicity. ~~and~~In ~~inflammatory~~this ~~disorders.~~regard, ~~Regardless~~ChemoPrepTM ofaligns ~~these~~with ~~factors,~~the FDA ~~may~~“Project ~~require~~Optimus” initiative ~~that~~to weminimize ~~conduct~~the ~~additional~~toxicity ~~animal~~of ~~studies~~cancer drugs while maximizing patient benefit.

~~Sigyn~~ChemoPureTM to ~~TherapyTM~~Reduce ~~Clinical~~Chemotherapy ~~Plan~~Toxicity

~~The data resulting from our~~Once inchemotherapy ~~vivo animal and pre-clinical in vitro studies~~ has been ~~incorporated~~administered, inresidual anoff-target ~~Investigational~~chemotherapy ~~Device Exemption (IDE)~~ that we ~~have~~is ~~drafted~~left ~~for submission~~ to ~~the~~circulate ~~U.S. Food and Drug Administration (“FDA”) to support first-~~in~~-human~~ ~~feasibility~~the ~~studies of~~bloodstream ~~Sigyn~~is ~~Therapy.~~more ~~The~~likely ~~clinical plan of our IDE proposes~~ to ~~enroll 12-15 End-Stage Renal Disease (“ESRD”) patients with endotoxemia~~cause ~~and~~patient ~~concurrent~~harm ~~inflammation~~versus ~~at three clinical site locations that have been identified and evaluated by a contract research organization that specializes in ESRD related clinical studies~~benefit. ~~The~~In ~~primary study objective is to demonstrate that Sigyn Therapy can be safely administered to health compromised ESRD subjects. Additionally~~response, we ~~plan~~designed ChemoPureTM to ~~quantify~~extract ~~changes~~off-target inchemotherapy ~~endotoxin~~from ~~levels~~the ~~as well as markers of inflammation~~bloodstream ~~as secondary endpoints. The clinical plan proposed in our draft IDE has not yet been provided~~ to ~~FDA~~further ~~and~~reduce ~~there~~treatment ~~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 TherapyTM~~toxicity.

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. However, Sigyn Therapy 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.30

About Sigyn Therapy ~~Mechanism of~~- ~~Action~~Our Lead Therapeutic Candidate

WeTo address infectious disease disorders that are not treatable with drugs, we designed Sigyn ~~Therapy~~TherapyTM to extract deadly pathogens and toxins from a patient’s bloodstream, while simultaneously providing a mechanism to ~~treat~~dampen ~~life-threatening~~down ~~infectious~~excessive ~~disease~~immune ~~disorders~~responses that are ~~not~~associated ~~addressed~~ with ~~drug~~life-threatening ~~therapies~~infections. ~~Based~~Sigyn onTherapyTM ~~its~~has ~~ability~~been validated to extract viral pathogens, bacterial toxins (including endotoxin), hepatic toxins and inflammatory cytokines from human blood plasma,. These expansive capabilities establish Sigyn TherapyTM ~~establishes~~ as a novel strategy to address several unmet needs in global health., ~~These~~including ~~include~~ untreatable viral pathogens, ~~antibiotic~~ antibiotic-resistant bacterial infections, endotoxemia, and sepsis.

~~To support widespread implementation,~~ Sigyn ~~Therapy is a single-use disposable device that is deployable on the global infrastructure of hemodialysis and continuous renal replacement~~ ~~therapy~~TherapyTM ~~(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~~Pre-~~of-care~~Clinical drug administered in dialysis and CRRT therapies. During animal studies conducted at the University of Michigan, Sigyn Therapy was deployed for use on a dialysis machine manufactured by Fresenius Medical Care, a global leader in the dialysis industry.Studies

31Since the inception of our Company, we have advanced Sigyn Therapy 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. 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.

~~Incorporated within~~ Sigyn ~~Therapy~~TherapyTM isAnimal 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.Studies

~~Sigyn~~Subsequent to ~~Therapy~~our ispre-clinical ~~not~~in ~~constrained by~~vitro ~~such~~studies, ~~limitations~~we asdisclosed ~~active~~the ~~adsorbent~~completion ~~components~~of ~~are~~in ~~maintained~~vivo ~~within~~animal studies. In these studies, Sigyn Therapy was ~~and~~administered ~~not~~via ~~introduced~~standard ~~into~~dialysis ~~the~~machines ~~body.~~utilizing Asconventional ablood-tubing ~~result~~sets, we ~~are~~for ~~able~~periods of up to ~~incorporate~~six ahours ~~substantial~~to ~~quantity~~eight (8) porcine (pig) subjects, each weighing approximately 40-45 kilograms. The studies were comprised of ~~adsorbent~~a ~~components~~pilot tophase ~~capture~~(two ~~therapeutic~~subjects), ~~targets~~which evaluated ~~outside~~the feasibility of the ~~body~~study asprotocol ~~they~~in ~~circulate through~~the first-in-mammal use of Sigyn Therapy; and an expansion phase (six subjects) to further assess treatment feasibility and refine pre-treatment set-up and operating procedures. ~~Each~~There ~~adsorbent~~were ~~component~~no ~~has~~serious ~~differing~~adverse ~~capture~~events ~~characteristics~~reported in ~~that~~any ~~contribute~~of tothe ~~optimizing~~treated animal subjects. Of the ~~potential~~eight oftreatments, ~~Sigyn~~seven were administered for the entire six-hour treatment period. One ~~Therapy~~treatment was halted early due to ~~reduce~~the observation of a clot in the ~~circulating~~device, ~~presence~~which ofwas ~~both~~believed ~~pathogen~~to ~~and~~be ~~inflammatory~~the ~~targets~~result ~~that~~of ~~underly~~a ~~sepsis~~procedural ~~and~~deviation in ~~other~~the ~~life~~pre-~~threatening~~treatment ~~infectious~~set-up. Important criteria for treatment feasibility – including hemodynamic parameters, serum chemistries ~~disease~~and ~~disorders~~hematologic measurements – were stable across all subjects.

The studies ~~adsorbent~~were ~~components incorporated~~conducted ~~within~~by ~~Sigyn~~a ~~Therapy~~clinical ~~provide~~team ~~more~~at ~~than~~Innovative ~~200~~BioTherapies,~~000~~ ~~square~~Inc. ~~meters~~ (~~~50 acres~~“IBT”), ofunder ~~surface~~a ~~area~~contract onwith ~~which~~the ~~to adsorb and remove therapeutic~~University ~~targets~~of ~~from~~Michigan ~~the~~to ~~bloodstream.~~utilize ~~Beyond~~animal ~~its~~care, ~~capacity~~associated toinstitutional ~~reduce~~review ~~the~~oversight, ~~circulating~~as ~~presence~~well ofas ~~therapeutic~~surgical ~~targets~~suite wefacilities ~~believe~~located ~~Sigyn~~within ~~Therapy to~~the beNorth aCampus ~~highly~~Research ~~efficient~~Complex. The treatment ~~methodology.~~protocol ~~Based~~of onthe ~~targeted~~study ~~blood~~was ~~flow~~reviewed ~~rates~~and ofapproved ~~350ml/min,~~by the ~~entire~~University ~~bloodstream~~ of anMichigan ~~average size~~Institutional ~~person~~Animal ~~can~~Care beand ~~processed~~Use ~~through~~Committee ~~Sigyn Therapy approximately fifteen times during a single four-hour treatment period~~(“IACUC”).

~~From a technical perspective,~~The ~~Sigyn~~animal ~~Therapy~~studies iswere aconducted ~~325mm~~to ~~long~~correspond ~~polycarbonate column that internally contains polyethersulphone hollow fibers that have porous walls~~ with a ~~median~~FDA’s ~~pore~~best ~~size~~practice ~~of ~200 nanometers (nm)~~guidance. AsThe ~~blood~~number ~~flows~~of ~~into~~animals ~~Sigyn~~enrolled ~~Therapy,~~in ~~plasma~~our ~~and~~study ~~therapeutic targets below 200nm travel through~~and the ~~porous~~amount ~~walls as a result~~ of ~~blood-side~~data ~~pressure.~~collected Aswas ~~the~~based ~~hollow~~on ~~fiber bundle within Sigyn Therapy creates a resistance to~~ the ~~flow of~~ethical ~~blood,~~and aleast ~~pressure~~burdensome ~~drop~~principles isthat ~~created~~underly ~~along~~ the ~~length~~FDA goal of ~~the~~using ~~device such that~~ the ~~blood-side pressure is higher at the blood inlet and~~minimum ~~lower~~number atof ~~the~~animals ~~blood~~necessary ~~outlet.~~to ~~This~~generate ~~allows~~valid ~~for~~scientific ~~plasma~~data ~~and therapeutic targets~~ to ~~flow~~demonstrate ~~away~~reasonable ~~from~~feasibility ~~the blood~~ and ~~into~~performance ~~the~~of ~~extra-lumen~~a ~~space~~medical ~~(inside~~device ~~the~~prior ~~polycarbonate shell, yet outside the hollow-fiber bundle)~~ to ~~interact~~human ~~with~~study ~~Sigyn~~consideration. ~~Therapy’s~~A ~~adsorbent~~porcine ~~components~~animal inmodel is a ~~low~~generally ~~shear force~~accepted ~~environment.~~model Infor the ~~distal~~study ~~third~~ of ~~the~~extracorporeal ~~fiber~~blood ~~bundle, the pressure gradient is reversed, which allows for plasma to flow back through~~purification ~~the~~devices ~~fiber~~intended ~~walls~~ to betreat ~~reconvened~~infectious ~~into~~disease ~~the~~and ~~bloodstream~~inflammatory ~~without~~disorders. ~~the~~Regardless ~~presence~~ of ~~therapeutic~~these ~~targets~~factors, ~~that~~FDA ~~were~~may ~~captured~~require orthat ~~bound~~we ~~by adsorbent~~conduct ~~components~~additional ~~housed~~animal ~~in the extra-lumen space of Sigyn Therapy~~studies.

~~Opportunities to Address~~Sigyn ~~Unmet~~TherapyTM ~~Needs~~Clinical ~~in Global Health~~Plan

~~Based~~The data onresulting ~~data~~from ~~obtained~~our ~~during~~in vivo animal and pre-clinical in vitro ~~validation~~ studies, has been incorporated in an Investigational Device Exemption (IDE) that we ~~are~~have ~~advancing~~drafted for submission to the U.S. Food and Drug Administration (“FDA”) to support first-in-human feasibility studies of Sigyn ~~TherapyTM~~Therapy. The clinical plan of our IDE proposes to ~~address~~enroll ~~several~~12-15 ~~unmet~~End-Stage ~~needs~~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 ~~global~~ESRD ~~health~~related clinical studies. ~~These~~The ~~include~~primary ~~untreatable~~study objective is to demonstrate that Sigyn Therapy ~~viral~~can ~~pathogen,~~be ~~antibiotic~~safely ~~resistant~~administered ~~bacterial~~to ~~infections,~~health ~~endotoxemia~~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 ~~sepsis~~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 TherapyTM.

~~Untreatable Viral Pathogens~~31

ABased on ~~majority~~our ofprevious ~~200+~~experience ~~viruses~~in ~~that~~developing ~~are~~extracorporeal ~~known~~blood topurification betherapies, ~~infectious to~~we ~~humans~~believe ~~are~~we ~~not~~have ~~treatable~~collected ~~with~~sufficient ~~drug~~data ~~therapies~~to support first-in-human studies of Sigyn Therapy. ~~Furthermore~~However, ~~newly~~Sigyn ~~emerging~~Therapy ~~viruses~~is ~~will~~a ~~remain~~Class ~~drug-resistant~~III ~~until~~device athat ~~corresponding drug~~requires isextensive ~~developed~~pre-clinical and clinical ~~demonstrated~~studies to be ~~safe~~conducted ~~and~~along ~~effective~~with inthe ~~human~~submission ~~studies.~~of As a ~~result,~~Pre-Market ~~extracorporeal~~Approval ~~blood~~(PMA) ~~purification~~application ~~therapies are~~prior ~~increasingly~~to ~~being~~market ~~deployed~~clearance asconsideration by ~~first-line treatment countermeasures~~FDA.

~~The first blood purification device to receive FDA~~Sigyn ~~Emergency-Use~~Therapy ~~Authorization~~Mechanism ~~approval to treat a pandemic virus was the Hemopurifier to treat Ebola, which occurred under the leadership~~ of our CEO. 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.Action

~~Consistent~~We designed ~~with~~Sigyn ~~FDA’s statement,~~Therapy ~~pediatric~~to ~~versions~~treat oflife-threatening ~~Sigyn~~infectious ~~Therapy~~disease ~~have~~disorders ~~demonstrated~~that anare ~~ability~~not toaddressed ~~reduce~~with ~~the~~drug ~~presence~~therapies. ofBased ~~various~~on its ability to extract viral pathogens, ~~cytokines~~bacterial toxins (including endotoxin), hepatic toxins and ~~other~~ inflammatory ~~mediators~~cytokines from human blood plasma~~. As such~~, ~~we believe~~ Sigyn ~~Therapy~~TherapyTM ~~offers~~establishes ana ~~important~~novel ~~candidate~~ strategy to ~~treat future~~address ~~pandemic~~several ~~outbreaks,~~unmet ~~which~~needs ~~are~~in ~~increasingly~~global ~~being~~health. ~~fueled~~These byinclude auntreatable viral ~~confluence~~pathogens, ofantibiotic ~~global~~resistant ~~warming~~bacterial infections, ~~urban crowding~~endotoxemia, and ~~intercontinental travel~~sepsis.

32To support widespread implementation, Sigyn Therapy is a single-use disposable device that is deployable on the global infrastructure of hemodialysis and continuous renal replacement therapy (CRRT) machines already located in hospitals and clinics. To reduce the risk of blood clotting and hemolysis, the anticoagulant heparin is administered, which is the standard-of-care drug administered in dialysis and CRRT therapies. During animal studies conducted at the University of Michigan, Sigyn Therapy was deployed for use on a dialysis machine manufactured by Fresenius Medical Care, a global leader in the dialysis industry.

~~Additionally, as many infectious~~Incorporated ~~viruses~~within ~~are~~Sigyn ~~not~~Therapy ~~addressed~~is ~~with~~ a ~~corresponding~~“cocktail” ~~drug~~of oradsorbent ~~vaccine,~~components ~~there~~formulated ~~may~~to beoptimize anthe ~~ongoing~~broad-spectrum ~~need~~reduction ~~for~~of ~~blood~~therapeutic targets ~~purification~~from ~~technologies~~the ~~that offer~~bloodstream. toIn ~~reduce~~the medical field, the ~~severity~~term of“cocktail” ~~infection~~is ~~and~~a ~~mitigate~~reference to the ~~excess~~simultaneous ~~production~~ administration of ~~inflammatory~~multiple ~~cytokines~~drugs (~~the~~a ~~cytokine~~drug ~~storm~~cocktail) ~~associated~~ with ~~high~~differing ~~mortality~~mechanisms inof ~~non-pandemic viral infections~~actions. ~~Sigyn~~While ~~Therapy~~drug ~~also~~cocktails ~~aligns~~are ~~with~~emerging ~~government~~as ~~initiatives~~potential mechanisms to treat ~~support~~cancer, ~~the~~they ~~development of~~are ~~broad~~life-~~spectrum~~saving ~~medical~~ countermeasures ~~that~~to ~~could~~treat ~~help~~HIV ~~mitigate~~and ~~the~~Hepatitis-C ~~impact~~viral infections. However, dosing of anmulti-drug ~~emerging~~agent cocktails ~~pandemic~~is orlimited ~~bioterror~~by ~~threat~~toxicity ~~yet~~and ~~may~~adverse ~~also have~~events ~~viability~~that incan ~~established~~result ~~disease~~from ~~indications~~deleterious drug interactions.

~~Antibiotic~~Sigyn Therapy is not constrained by such limitations as active adsorbent components are maintained within Sigyn Therapy and not introduced into the body. As a result, we are able to incorporate a substantial quantity of adsorbent components to capture therapeutic targets outside of the body as they circulate through Sigyn Therapy. Each adsorbent component has differing capture characteristics that contribute to optimizing the potential of Sigyn Therapy to reduce the circulating presence of both pathogen and inflammatory targets that underly sepsis and other life-~~Resistant~~threatening ~~Bacterial~~infectious ~~Infections~~disease disorders.

~~According~~The adsorbent tocomponents ~~the~~incorporated ~~U.S.~~within ~~Centers~~Sigyn ~~for~~Therapy ~~Disease~~provide ~~Control and~~more ~~Prevention~~than ~~(“CDC”)~~200,000 ~~nearly~~square ~~three~~meters ~~million~~(~50 ~~individuals~~acres) ~~are~~of ~~infected~~surface ~~with~~area ~~antibiotic~~on ~~resistant~~which ~~bacterial infections in the~~to ~~U.S.~~adsorb ~~each~~and ~~year,~~remove ~~which~~therapeutic ~~results~~targets infrom ~~more~~the ~~than 35,000 deaths~~bloodstream. ~~The~~Beyond ~~United~~its ~~Nations~~capacity ~~reported~~to ~~approximately~~reduce 5the ~~million~~circulating ~~deaths~~presence inof ~~2019~~therapeutic ~~were associated~~targets ~~with~~we ~~antimicrobial~~believe ~~drug~~Sigyn ~~resistance~~Therapy ~~and projects the annual death toll could increase~~ to 10be ~~million~~a byhighly ~~2050~~efficient intreatment ~~the absence of new therapeutic advances~~methodology. Based on ~~its~~targeted ~~broad-spectrum~~blood ~~mechanism~~flow torates ~~extract~~of ~~bacterial~~350ml/min, ~~toxins~~the ~~and~~entire bloodstream ~~inflammatory~~of ~~mediators~~an ~~from~~average ~~the~~size ~~bloodstream,~~person ~~Sigyn~~can ~~Therapy may~~be ~~provide~~processed athrough ~~novel~~Sigyn ~~strategy~~Therapy toapproximately ~~assist~~fifteen intimes ~~the~~during ~~treatment~~a ofsingle ~~antibiotic~~four-~~resistant~~hour ~~bacterial infections~~treatment period.

~~Endotoxemia~~From a technical perspective, Sigyn Therapy is a 325mm long polycarbonate column that internally contains polyethersulphone hollow fibers that have porous walls with a median pore size of ~200 nanometers (nm). As blood flows into Sigyn Therapy, plasma and therapeutic targets below 200nm travel through the porous walls as a result of blood-side pressure. As the hollow fiber bundle within Sigyn Therapy creates a resistance to the flow of blood, a pressure drop is created along the length of the device such that the blood-side pressure is higher at the blood inlet and lower at the blood outlet. This allows for plasma and therapeutic targets to flow away from the blood and into the extra-lumen space (inside the polycarbonate shell, yet outside the hollow-fiber bundle) to interact with Sigyn Therapy’s adsorbent components in a low shear force environment. In the distal third of the fiber bundle, the pressure gradient is reversed, which allows for plasma to flow back through the fiber walls to be reconvened into the bloodstream without the presence of therapeutic targets that were captured or bound by adsorbent components housed in the extra-lumen space of Sigyn Therapy.

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.32

~~According to the United States Renal Data System (“USRDS”),~~Opportunities 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~~Address ~~dialysis~~Unmet ~~industry, which~~Needs ~~is dominated by Fresenius Medical Care and DaVita, Inc.~~ in ~~North~~Global ~~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.~~Health

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

~~Sepsis is defined as a life-threatening~~Untreatable ~~organ~~Viral 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.Pathogens

ToA majority ~~date,~~of ~~more~~200+ ~~than~~viruses ~~100~~that ~~human studies~~are ~~have~~known ~~been conducted~~ to ~~evaluate~~be ~~the~~infectious ~~safety~~to ~~and~~humans ~~efficacy~~are ofnot ~~candidate~~treatable ~~drugs~~with todrug ~~treat sepsis~~therapies. ~~With~~Furthermore, ~~one~~newly ~~brief exception (Xigris,~~emerging ~~Eli~~viruses ~~Lilly),~~will ~~none~~remain ofdrug-resistant ~~these~~until ~~studies resulted in~~ a ~~market~~corresponding ~~cleared~~drug ~~therapy. As sepsis remains beyond the reach of single-target drugs, there~~ is adeveloped ~~growing~~and ~~interest~~demonstrated into ~~multi-mechanism~~be ~~therapies~~safe ~~that can simultaneously address both inflammatory~~ and ~~pathogen~~effective ~~associated~~in ~~targets~~human studies. ~~Sigyn~~As ~~Therapy offers to addresses~~ a ~~broad-spectrum~~result, ofextracorporeal ~~pathogen~~blood ~~sources~~purification ~~and~~therapies ~~the~~are ~~resulting~~increasingly ~~dysregulated~~being ~~cytokine~~deployed ~~production~~as ~~(the~~first-line ~~cytokine storm)~~treatment ~~that is a hallmark of sepsis~~countermeasures.

~~Emerging~~The first ~~Opportunity~~blood ~~for~~purification ~~Sigyn~~device ~~Therapy~~to inreceive ~~Xenotransplantation~~FDA Emergency-Use Authorization approval to treat a pandemic virus was the Hemopurifier to treat Ebola, which occurred under the leadership of our CEO. 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.

~~Beyond~~Consistent with ~~the~~FDA’s ~~post-exposure~~statement, ~~treatment~~pediatric versions of ~~infectious disease disorders,~~ Sigyn ~~TherapyTM~~Therapy ~~offers~~have ademonstrated ~~potential~~an ~~preventative~~ability ~~strategy~~ to reduce the ~~spread~~presence of ~~infection~~various ~~in organ transplantation~~pathogens, ~~including xenotransplantation~~cytokines, anand ~~emerging~~other ~~field~~inflammatory ~~related~~mediators ~~to the transplantation of an organ~~ from ~~a donor animal species into a~~ human ~~recipient~~blood plasma. ~~The~~ ~~advancement~~As ofsuch, ~~xenotransplantation~~we isbelieve ~~being~~Sigyn ~~fueled~~Therapy byoffers aan ~~global~~important ~~shortage of transplantable human organs and the recent emergence of~~candidate ~~gene-editing~~strategy ~~technologies~~to ~~that~~treat ~~have~~future ~~increased~~pandemic ~~the compatibility of porcine-derived (pig) kidneys for human transplantation. In the United States~~outbreaks, ~~approximately~~which ~~90,000 individuals~~ are onincreasingly ~~the~~being ~~waitlist~~fueled ~~for~~by a ~~kidney~~confluence ~~transplant,~~of ~~yet~~global ~~fewer~~warming, ~~than~~urban 30crowding,~~000~~ ~~kidney transplants are performed~~and ~~each~~intercontinental ~~year~~travel.

33Additionally, 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 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.

~~To optimize xenotransplantation outcomes, Sigyn TherapyTM~~Antibiotic-Resistant isBacterial ~~proposed for administration to:~~Infections

	1.	Gene-edited donor pigs to reduce pathogen accumulation in donor kidneys prior to their extraction for human transplantation. The feasibility of Sigyn TherapyTM administration has been demonstrated in eight (8) porcine subjects to date.
	2.	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.

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 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 may provide a novel strategy to assist in the treatment of antibiotic-resistant bacterial infections.

~~This use of Sigyn TherapyTM in these applications~~Endotoxemia ~~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~~Endotoxin is toa ~~Optimize~~gram-negative bacterial toxin whose bloodstream presence commonly induces sepsis, the ~~Benefit~~leading cause of ~~Cancer~~death ~~Therapies~~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.

~~We are not a developer of drugs~~ According to ~~treat~~the ~~cancer.~~United ~~We are~~States aRenal ~~developer~~Data ofSystem ~~medical~~(“USRDS”), ~~devices~~more tothan ~~optimize~~550,000 ~~the~~individuals ~~benefit~~have ofESRD, ~~drugs~~which toresults ~~treat~~in ~~cancer,~~approximately 85 ~~the~~million ~~2nd~~kidney ~~leading~~dialysis ~~cause~~treatments ofbeing ~~death~~administered in the United States. ~~Our~~each ~~therapeutic~~year. ~~candidates~~A ~~include~~therapy ~~the~~that ~~ImmunePrepTM~~could ~~platform~~help toextend ~~enhance~~ the ~~performance~~lives of ~~immunotherapeutic~~ ~~antibodies,~~these ~~ChemoPrepTM~~patients tomay ~~improve~~have ~~the~~a ~~delivery~~quantifiable ofvalue ~~chemotherapy~~to the dialysis industry, ~~and~~which ~~ChemoPureTM~~is todominated ~~extract~~by ~~off-target~~Fresenius ~~chemotherapy from~~Medical ~~the~~Care ~~bloodstream~~and toDaVita, ~~reduce~~Inc. in ~~treatment~~North ~~toxicity~~America. AtBased ~~present,~~on wethe donumber ~~not~~of ~~have~~ESRD ~~any~~patients ~~market~~treated ~~approved~~in ~~products~~their tonetworks, ~~treat~~every ~~cancer~~month ~~and~~of ~~there~~extended ~~is no~~life ~~assurance~~would ~~that~~equate weto ~~will~~approximately $1 ~~commercialize~~billion ~~any~~in ofadded ~~our~~revenues ~~proposed~~for ~~cancer~~each ~~therapies~~company.

Unlike Sigyn TherapyTM to treat infectious disease disorders, the intent of ImmunePrepTM and ChemoPrepTM is to optimize the delivery of leading drugs to treat cancer, while ChemoPureTM introduces a strategy to reduce chemotherapy toxicity. Additionally, Sigyn TherapyTM is a hollow fiber-based device deployed for use on dialysis and continuous renal replacement machines. Whereas ImmunePrepTM, ChemoPrepTM and ChemoPureTM do not contain hollow-fibers and are intended for use on portable blood processing systems that can be located within the clinical sites where 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 ImmunePrepTM products, therapeutic antibodies are immobilized for selective elimination of drug decoys and antibody therapeutic targets from the bloodstream. ChemoPrepTM and ChemoPureTM incorporate 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.33

~~ImmunePrepTM to Optimize Immunotherapeutic Antibodies~~Sepsis

~~Immunotherapeutic~~Sepsis is ~~antibodies~~defined ~~(monoclonal~~as ~~antibodies, therapeutic~~a ~~antibodies,~~life-threatening ~~checkpoint~~organ ~~inhibitors,~~dysfunction ~~antibody~~caused ~~drug~~by ~~conjugates)~~a ~~generate~~dysregulated ~~more~~host ~~revenues~~response ~~than~~to ~~any~~infection. ~~other~~In ~~class~~January of ~~drug~~2020, toa ~~treat~~report ~~cancer~~entitled; “Global, Regional, and ~~are~~National ~~the~~Sepsis ~~most~~Incidence ~~valued~~and ~~assets~~Mortality, in1990-2017: ~~global~~Analysis ~~medicine~~for ~~based~~the onGlobal ~~2023~~Burden ~~and~~of ~~2024~~Disease Study,” ~~M&A~~reported ~~transactions~~48.9 ~~However,~~million ~~therapeutic~~cases ~~antibodies are~~of ~~poorly~~sepsis ~~delivered~~and to11 ~~their~~million ~~intended~~deaths ~~cancer~~in ~~targets~~2017. ~~and~~In asthat asame ~~result~~year, ~~most~~an ~~patients~~estimated ~~don’t~~20.3 ~~respond~~million tosepsis cases ~~therapy~~and 2.9 Inmillion ~~many~~deaths ~~cases,~~were ~~less~~ among children younger than 2%5-years ofold. anThe ~~antibody~~report ~~dose~~included ~~will~~a ~~reach~~reference ~~its~~that ~~cancer~~sepsis ~~target,~~kills ~~yet~~more apeople around ~~significant~~the ~~portion~~world ofthan ~~same~~all ~~dose~~forms ~~can~~of becancer ~~intercepted~~combined. byIn ~~high~~the ~~concentrations of~~United ~~circulating~~States, ~~decoys~~sepsis ~~that~~was ~~display~~reported to be the ~~antigen~~most ~~binding~~common ~~site~~cause of ~~the~~hospital deaths ~~antibody~~with an annual financial burden that exceeds $24 billion.

~~In response~~To date, wemore ~~invented~~than ~~the~~100 ~~ImmunePrepTM platform~~human tostudies ~~allow~~have ~~for~~been aconducted ~~therapeutic antibody~~ to beevaluate ~~immobilized~~the ~~within~~safety anand ~~extracorporeal~~efficacy ~~circuit to sweep antibody decoys out~~ of ~~the~~candidate ~~bloodstream prior~~drugs to ~~the~~treat ~~subsequent~~sepsis. ~~infusion~~With ofone brief ~~the~~exception ~~antibody~~(Xigris, toEli aLilly), ~~patient.~~none Weof ~~believe~~these ~~this~~studies ~~reverse~~resulted ~~decoy~~in ~~mechanism~~a ~~will~~market ~~improve~~cleared ~~targeted~~therapy. ~~antibody delivery~~As ~~and~~sepsis ~~simultaneously~~remains ~~reduce~~beyond the ~~circulating~~reach ~~presence~~ of single-target ~~the~~drugs, ~~antibody’s~~there ~~cancer~~is ~~targets~~a togrowing ~~further~~interest ~~enhance~~in ~~patient~~multi-mechanism ~~benefit. As~~therapies athat ~~platform~~can ~~technology,~~simultaneously ~~ImmunePrepTM~~address ~~allows~~both ~~for~~inflammatory ~~the~~and ~~potential~~pathogen associated ~~development~~targets. ofSigyn ~~products~~Therapy ~~that~~offers ~~may~~to ~~incorporate~~addresses a ~~development~~broad-~~stage, clinical-stage~~spectrum orof ~~market-approved~~pathogen ~~antibody.~~sources ~~Based~~and onthe ~~previous~~resulting ~~FDA~~dysregulated ~~interactions,~~cytokine weproduction (the ~~believe~~cytokine ~~ImmunePrepTM~~storm) ~~products~~ that ~~incorporate market-approved~~is ~~antibodies~~a ~~may~~hallmark ~~have~~of ~~an accelerated pathway to potential market clearance~~sepsis.

34Emerging Opportunity for Sigyn Therapy in Xenotransplantation

~~ChemoPrepTM~~Beyond the post-exposure treatment of infectious disease disorders, Sigyn TherapyTM offers a potential preventative strategy to ~~Optimize~~reduce the ~~Chemotherapy~~spread of infection in organ transplantation, including xenotransplantation, an emerging field related to the transplantation of ~~Delivery~~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.

~~Chemotherapeutic agents are the most commonly administered~~To ~~class~~optimize ofxenotransplantation ~~drug to treat cancer~~outcomes, ~~yet~~Sigyn ~~only~~TherapyTM ais ~~small~~proposed ~~fraction~~for 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 ChemoPrepTM 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, ChemoPrepTM aligns with the FDA “Project Optimus” initiative to minimize the toxicity of cancer drugs while maximizing patient benefit.:

ChemoPureTM to Reduce Chemotherapy Toxicity

	1.	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.

	2.	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.

~~Once~~This use ~~chemotherapy~~of ~~has~~Sigyn ~~been~~TherapyTM ~~administered,~~in ~~residual off-target~~these ~~chemotherapy~~applications ~~that~~corresponds iswith ~~left~~published toFDA ~~circulate~~guidance inon the ~~bloodstream~~need isfor ~~more~~strategies ~~likely~~ to ~~cause~~mitigate the ~~patient~~risk ~~harm~~of ~~versus~~a ~~benefit.~~known Inor ~~response, we~~unknown ~~designed~~pathogen ~~ChemoPureTM~~being totransmitted ~~extract off-target chemotherapy~~ from ~~the~~a ~~bloodstream~~porcine-derived organ to ~~further~~a ~~reduce~~human ~~treatment~~transplant ~~toxicity~~recipient.

~~Marketing~~Devices to ~~and~~Optimize ~~Sales~~the Benefit of Cancer Therapies

~~Our~~We are ~~primary~~not ~~focus~~a isdeveloper ~~the regulatory~~of ~~and~~drugs ~~clinical~~to ~~advancement~~treat cancer. We are a developer of ~~Sigyn~~medical ~~Therapy~~devices ~~and~~to optimize the ~~continued~~benefit ~~development~~ of ~~our~~drugs to treat cancer, the ~~treatment~~2nd ~~technologies.~~leading Wecause doof ~~not~~death ~~market or~~in ~~sell~~the ~~any~~United States. Our therapeutic ~~products~~candidates atinclude ~~this~~the ~~time.~~ImmunePrepTM ~~However,~~platform to weenhance ~~may~~the ~~choose~~performance of immunotherapeutic antibodies, ChemoPrepTM to ~~forge~~improve ~~relationships~~the ~~with~~delivery ~~organizations~~of ~~that~~chemotherapy, ~~have~~and ~~established~~ChemoPureTM ~~distribution~~to ~~channels~~extract ~~into~~off-target ~~markets~~chemotherapy ~~that~~from ~~may~~the ~~have~~bloodstream ato ~~demand~~reduce ~~for~~treatment ~~our~~toxicity. ~~therapies~~At ~~should~~present, ~~they~~we ~~receive~~do not have any market ~~clearance~~approved products ~~from~~to ~~FDA~~treat orcancer ~~other~~and ~~foreign regulatory~~there ~~agencies~~is no assurance that we will commercialize any of our proposed cancer therapies.

~~Intellectual~~Unlike Sigyn ~~Property~~TherapyTM to treat infectious disease disorders, the intent of ImmunePrepTM and ChemoPrepTM is to optimize the delivery of leading drugs to treat cancer, while ChemoPureTM introduces a strategy to reduce chemotherapy toxicity. Additionally, Sigyn TherapyTM is a hollow fiber-based device deployed for use on dialysis and continuous renal replacement machines. Whereas ImmunePrepTM, ChemoPrepTM and ChemoPureTM do not contain hollow-fibers and are intended for use on portable blood processing systems that can be located within the clinical sites where 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 ImmunePrepTM products, therapeutic antibodies are immobilized for selective elimination of drug decoys and antibody therapeutic targets from the bloodstream. ChemoPrepTM and ChemoPureTM incorporate 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.

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, 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.34

~~At present, we own the rights~~ImmunePrepTM to ~~the~~Optimize ~~following~~Immunotherapeutic ~~patents pending.~~Antibodies

~~EXTRACORPOREAL~~Immunotherapeutic antibodies ~~THERAPIES~~(monoclonal antibodies, therapeutic antibodies, checkpoint inhibitors, antibody drug conjugates) generate more revenues than ~~FOR~~any ~~XENOTRANSPLANTATION~~other –class ~~U.S.~~of ~~Patent~~drug ~~Application~~to ~~No.:~~treat ~~63/707,507;~~cancer ~~Priority~~and ~~Date:~~are ~~10/15/2024~~the -most ~~Inventors:~~valued ~~James~~assets in global medicine based on 2023 and 2024 M&A transactions. However, ~~Joyce~~therapeutic antibodies are poorly delivered to their intended cancer targets and ~~Annette~~as a result, most patients don’t respond Mto therapy. ~~Marleau~~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.

~~DEVICES~~In response, ~~FOR~~we ~~ENHANCING~~invented ~~THE~~the ImmunePrepTM platform to allow for a therapeutic antibody to be immobilized within an extracorporeal ~~ACTIVITY~~circuit OFto ~~THERAPEUTIC~~sweep ~~ANTIBODIES~~antibody –decoys ~~International~~out ~~Patent~~of ~~Application~~the Nobloodstream prior to the subsequent infusion of the antibody to a patient.: ~~PCT/US2024/028579;~~We ~~Priority~~believe ~~Date:~~this reverse ~~05/10/2023~~decoy -mechanism ~~Inventors:~~will improve targeted antibody delivery and simultaneously reduce the circulating presence of the antibody’s ~~James~~cancer Atargets to further enhance patient benefit. ~~Joyce~~As ~~and~~a ~~Annette~~platform Mtechnology, ImmunePrepTM allows for the potential development of products that may incorporate a development-stage, clinical-stage or market-approved antibody. ~~Marleau~~Based on previous FDA interactions, we believe ImmunePrepTM products that incorporate market-approved antibodies may have an accelerated pathway to potential market clearance.

~~SYSTEM AND METHODS TO ENHANCE~~ChemoPrepTM ~~CHEMOTHERAPY~~to ~~DELIVERY~~Optimize ~~AND~~Chemotherapy ~~REDUCE TOXICITY – U.S. Patent Application No.: 18/373,829; Priority Date: 09/28/2022 - Inventor: James A. Joyce~~Delivery

~~SYSTEM~~Chemotherapeutic agents ~~AND~~are ~~METHODS~~the TOmost ~~ENHANCE~~commonly administered class of drug to treat cancer, yet only a small fraction of infused doses reach their cancer ~~CHEMOTHERAPY~~cell ~~DELIVERY~~targets. ~~AND~~Contributing ~~REDUCE~~to ~~TOXICITY~~inadequate –delivery ~~International~~are ~~Patent~~high ~~Application~~concentrations Noof tumor-derived exosomes, whose bloodstream presence disrupts chemotherapy delivery and corresponds with treatment resistance.: ~~PCT/US2023/033878;~~We ~~Priority~~designed ~~Date:~~ChemoPrepTM ~~09/28/2022~~to reduce the circulating presence of tumor-derived exosomes prior chemotherapy administration. Our clinical goal is to maintain or improve the efficacy of chemotherapy ~~Inventor:~~with ~~James~~lower Adoses, which would reduce treatment toxicity. ~~Joyce~~In this regard, ChemoPrepTM aligns with the FDA “Project Optimus” initiative to minimize the toxicity of cancer drugs while maximizing patient benefit.

~~EXTRA-LUMEN ADSORPTION OF~~ChemoPureTM ~~VIRAL~~to ~~PATHOGENS~~Reduce ~~FROM~~Chemotherapy ~~BLOOD – U.S. Patent Application No.: 18/802,722; Priority Date: 2021-04-21- Inventor: James A. Joyce~~Toxicity

~~EXTRA~~Once chemotherapy has been administered, residual off-~~LUMEN~~target ~~ADSORPTION~~chemotherapy ~~OF VIRAL~~that ~~PATHOGENS~~is ~~FROM~~left ~~BLOOD~~to –circulate EPin ~~No.:~~the ~~22722028~~bloodstream is more likely to cause patient harm versus benefit.2; ~~Priority~~In ~~Date:~~response, ~~2021-04-21~~we designed ChemoPureTM to extract off-target ~~Inventor:~~chemotherapy ~~James~~from A.the ~~Joyce~~bloodstream to further reduce treatment toxicity.

~~EXTRA-LUMEN ADSORPTION OF~~Marketing ~~VIRAL~~and ~~PATHOGENS FROM BLOOD – CA No.: 3,214,888; Priority Date: 2021-04-21 - Inventor: James A. Joyce~~Sales

35Our primary focus is the regulatory and clinical advancement of Sigyn Therapy 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.

~~EXTRA-LUMEN ADSORPTION OF~~Intellectual ~~VIRAL PATHOGENS FROM BLOOD – International Patent Application No.: PCT/US2022/025495; Priority Date: 2021-04-01 - Inventor: James A. Joyce~~Property

~~DEVICES,~~We own ~~SYSTEMS~~the ~~AND~~intellectual ~~METHODS FOR~~property ~~THE~~rights ~~BROAD~~to pending royalty-~~SPECTRUM~~free ~~REDUCTION~~patents OFthat ~~PRO-INFLAMMATORY~~have ~~CYTOKINES~~been INassigned ~~BLOOD~~to –us ~~International~~by ~~Patent~~our ~~Application~~CEO Noand other employee inventors.: We ~~PCT/US2020/044223;~~have also received a “Notice of Allowance” from the USPTO related to the use of Sigyn Therapeutics, Sigyn Therapy, and ~~Priority~~the ~~Date:~~protection ~~2019-08-01~~of -our ~~Inventors:~~corporate ~~James~~logo. ~~Joyce~~We plan to continually expand our intellectual property portfolio and ~~Craig~~protect Ptrade secrets that are not the subject of patent submissions. ~~Roberts~~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.

DEVICES, SYSTEMS AND METHODS FOR THE BROAD-SPECTRUM REDUCTION OF PRO-INFLAMMATORY CYTOKINES IN BLOOD – U.S. Patent Application No.: 16/943,436; Priority Date: 2019-08-01 - Inventors: James A. Joyce and Craig P. Roberts35

~~DEVICES~~At present, ~~SYSTEMS~~we ~~AND~~own ~~METHODS FOR~~the ~~THE~~rights ~~BROAD-SPECTRUM~~to ~~REDUCTION~~the OFfollowing ~~PRO-INFLAMMATORY~~patents ~~CYTOKINES IN BLOOD – EP No~~pending.~~: 20757445.0; Priority Date: 2019-08-01 - Inventors: James A. Joyce and Craig P. Roberts~~

~~DEVICES, SYSTEMS AND METHODS~~EXTRACORPOREAL THERAPIES FOR ~~THE~~XENOTRANSPLANTATION ~~BROAD-SPECTRUM~~– ~~REDUCTION~~U.S. OFPatent ~~PRO-INFLAMMATORY~~Application ~~CYTOKINES IN BLOOD – CA~~ No.: 363/707,~~148,773~~507; Priority Date: ~~2019-08-01~~10/15/2024 - Inventors: James A. Joyce and ~~Craig~~Annette PM. ~~Roberts~~Marleau

~~Government~~DEVICES FOR ~~Regulation~~ENHANCING THE ACTIVITY OF THERAPEUTIC ANTIBODIES – International Patent Application No.: PCT/US2024/028579; Priority Date: 05/10/2023 - Inventors: James A. Joyce and Annette M. Marleau

~~In the United States, our~~SYSTEM ~~medical~~AND ~~devices~~METHODS ~~are~~TO ~~subject~~ENHANCE toCHEMOTHERAPY ~~regulation~~DELIVERY byAND ~~the~~REDUCE ~~FDA.~~TOXICITY ~~Should~~– ~~we seek to commercialize our products outside the United States, we expect to face comparable international regulatory oversight. The~~ U.S. ~~regulatory~~Patent ~~jurisdiction~~Application ~~for~~No.: ~~extracorporeal~~18/373,829; ~~blood~~Priority ~~purification~~Date: ~~therapies~~09/28/2022 is- ~~the~~Inventor: ~~Center~~James ~~for Devices and Radiological Health (“CDRH”), the FDA branch that oversees the market approval of medical devices~~A. Joyce

~~Based on published CDRH guidance,~~SYSTEM weAND ~~believe~~METHODS ~~that~~TO ~~each~~ENHANCE ofCHEMOTHERAPY ~~our~~DELIVERY ~~therapeutic~~AND ~~candidates~~REDUCE ~~will~~TOXICITY be– ~~classified~~International asPatent ~~Class~~Application ~~III medical devices that are subject to a Pre-Market Approval (“PMA”) submission pathway~~No.: APCT/US2023/033878; ~~PMA pathway requires extensive data, including but not limited to technical documents, preclinical~~Priority ~~studies,~~Date: ~~animal~~09/28/2022 ~~studies,~~- ~~human~~Inventor: ~~clinical~~James trials, the establishment of Current Good Manufacturing Practices (“cGMPs”) standards and labelling that fulfils FDA’s requirement to demonstrate reasonable evidence of safety and effectiveness of a medical device productA. ~~However, as our therapeutic candidates do not emit electronic product radiation, they will not be subject to regulatory challenges associated with medical devices that emit electronic radiation.~~Joyce

~~The commercialization of~~EXTRA-LUMEN ~~medical~~ADSORPTION ~~devices~~OF inVIRAL ~~the~~PATHOGENS ~~United~~FROM ~~States~~BLOOD ~~requires~~– ~~either a prior 510(k) clearance, unless it is exempt, or a PMA from the FDA~~U. Generally, if a new device has a predicate that is already on the market under a 510(k) clearance, the FDA will allow that new device to be marketed under a 510(k) clearance; otherwise, a premarket approval, or PMA, is requiredS. ~~Medical~~Patent ~~devices~~Application are classified into one of three classes; Class I, Class II or Class III which are determined by the degree of risk associated with each medical device and the extent of control needed to provide reasonable assurance of safety and effectivenessNo. ~~Class I devices are deemed to be low risk and are subject to the general controls of the Federal Food, Drug and Cosmetic Act, such as provisions that relate to~~: ~~adulteration; misbranding; registration and listing; notification~~18/802, ~~including repair, replacement, or refund~~722; ~~records~~Priority ~~and~~Date: ~~reports; and good manufacturing practices. Most Class I devices are classified as exempt from pre~~2021-market notification under section 510(k) of the FD&C Act, and therefore may be commercially distributed without obtaining 510(k) clearance from the FDA. Class II devices are subject to both general controls and special controls to provide reasonable assurance of safety and effectiveness. Special controls include performance standards, post market surveillance, patient registries and guidance documents. A manufacturer may be required to submit to the FDA a pre04-~~market notification requesting permission to commercially distribute some Class II devices. Devices deemed by the FDA to pose the greatest risk, such as life~~21-~~sustaining,~~ ~~life-supporting~~Inventor: ~~or implantable~~James ~~devices, or devices deemed not substantially equivalent to a previously cleared 510(k) device, are placed in Class III.~~ A ~~Class III device cannot be marketed in the United States unless the FDA approves the device after submission of a PMA~~. ~~We believe that all of our therapeutic candidates will be classified as a Class III device and as such will be subject to a PMA submission and approval.~~Joyce

36EXTRA-LUMEN ADSORPTION OF VIRAL PATHOGENS FROM BLOOD – EP No.: 22722028.2; Priority Date: 2021-04-21 - Inventor: James A. Joyce

~~Should Sigyn Therapy or any~~EXTRA-LUMEN ofADSORPTION ~~our~~OF ~~other~~VIRAL ~~therapeutic~~PATHOGENS ~~candidates~~FROM ~~receive~~BLOOD ~~market~~– ~~clearance~~CA ~~from~~No.: ~~FDA~~3, ~~we would need to comply with applicable laws and regulations that govern the development~~214,888; ~~testing,~~Priority ~~manufacturing,~~Date: ~~labeling,~~2021-04-21 ~~marketing, storage, distribution, advertising and promotion, and post~~-~~marketing surveillance~~ ~~reporting~~Inventor: ~~for~~James ~~medical devices~~A. Failure to comply with these applicable requirements may subject a device and/or its manufacturer to a variety of administrative sanctions, such as issuance of warning letters, import detentions, civil monetary penalties and/or judicial sanctions, such as product seizures, injunctions and criminal prosecution. Our failure to comply with any of these laws and regulations could have a material adverse effect on our operations.Joyce

~~The~~EXTRA-LUMEN ADSORPTION ~~Pre~~OF VIRAL PATHOGENS FROM BLOOD – International Patent Application No.: PCT/US2022/025495; Priority Date: 2021-~~market~~04-01 ~~Approval~~- ~~Pathway~~Inventor: James A. Joyce

ADEVICES, SYSTEMS ~~pre-market~~AND ~~approval~~METHODS ~~(“PMA”) application~~FOR ~~must~~THE beBROAD-SPECTRUM ~~submitted~~REDUCTION toOF ~~FDA~~PRO-INFLAMMATORY ~~for~~CYTOKINES ~~Class~~IN ~~III~~BLOOD ~~devices~~– ~~requiring~~International aPatent ~~PMA~~Application No.: ~~The~~PCT/US2020/044223; ~~PMA~~Priority ~~application~~Date: ~~process is more demanding than the 510(k)~~2019-~~pre~~08-~~market notification~~01 ~~process.~~- AInventors: ~~PMA~~James ~~application~~Joyce ~~must be supported by extensive data, including but not limited to technical, preclinical, clinical trials, manufacturing~~ and ~~labeling~~Craig ~~to demonstrate to the FDA’s satisfaction reasonable evidence of safety and effectiveness of the device~~P. Roberts

~~After a PMA application is submitted~~DEVICES, SYSTEMS ~~the~~AND ~~FDA~~METHODS ~~has~~FOR 45THE ~~days~~BROAD-SPECTRUM toREDUCTION ~~determine~~OF ~~whether~~PRO-INFLAMMATORY ~~the~~CYTOKINES ~~application~~IN isBLOOD ~~sufficiently~~– ~~complete to permit a substantive review and thus whether the FDA will file the application for review~~U.S. ~~The~~Patent ~~FDA~~Application ~~has 180 days to review a filed PMA application, although the review of an application generally occurs over a significantly longer period of time and can take up to several years~~No.: ~~During this review period~~16/943, ~~the FDA may request~~436; ~~additional~~Priority ~~information~~Date: or2019-08-01 ~~clarification~~- ofInventors: ~~the~~James ~~information already provided~~A. ~~Also,~~Joyce ~~an advisory panel of experts from outside the FDA may be convened to review~~ and ~~evaluate~~Craig ~~the application and provide recommendations to the FDA as to the approvability of the device~~P. Roberts

~~Although the FDA is not bound~~DEVICES, bySYSTEMS ~~the~~AND ~~advisory~~METHODS ~~panel~~FOR ~~decision,~~THE ~~the~~BROAD-SPECTRUM ~~panel’s~~REDUCTION ~~recommendations~~OF ~~are~~PRO-INFLAMMATORY ~~important~~CYTOKINES toIN ~~the~~BLOOD ~~FDA~~– ~~decision~~EP ~~making~~No.: ~~process~~20757445.0; InPriority ~~addition, the FDA~~Date: ~~may~~2019-08-01 ~~conduct~~- aInventors: ~~preapproval~~James ~~inspection of the manufacturing facility to ensure compliance with the Quality System Regulation, or QSR~~A. ~~The agency~~Joyce ~~also~~and ~~may~~Craig ~~inspect one or more clinical sites to assure compliance with FDA’s regulations~~P. Roberts

~~Upon completion of the PMA review~~DEVICES, ~~the FDA may: (i) approve the PMA which authorizes commercial marketing with specific prescribing information for one or more indications,~~ ~~which~~SYSTEMS ~~can~~AND beMETHODS ~~more~~FOR ~~limited~~THE ~~than~~BROAD-SPECTRUM ~~those~~REDUCTION ~~originally~~OF ~~sought; (ii) issue an approvable letter which indicates the FDA’s belief that the PMA is approvable and states what additional information the FDA requires, or the post~~PRO-~~approval~~INFLAMMATORY ~~commitments~~CYTOKINES ~~that~~IN ~~must~~BLOOD be– ~~agreed~~CA toNo.: ~~prior to approval; (iii) issue a not approvable letter which outlines steps required for approval~~3, ~~but which are typically more onerous than those in an approvable letter~~148,773; ~~and~~Priority ~~may require additional clinical trials that are often expensive and time consuming and can delay approval~~Date: ~~for~~2019-08-01 ~~months~~- orInventors: ~~even~~James ~~years; or (iv) deny the application~~A. IfJoyce ~~the~~and ~~FDA~~Craig ~~issues an approvable or not approvable letter, the applicant has 180 days to respond, after which the FDA’s review clock is reset~~P. Roberts

~~Clinical Trials~~Government Regulation

~~Clinical trials are almost always required to support PMA market clearance and are sometimes required for 510(k) clearance.~~ In the United States, ~~for~~our ~~significant risk~~medical ~~Class III~~ devices, ~~these~~are ~~trials~~subject ~~require~~to ~~submission~~regulation ofby ~~an Investigational Device Exemption (IDE) application to~~ the FDA. ~~The~~Should ~~IDE~~we ~~application must~~seek beto ~~supported~~commercialize byour ~~appropriate~~products ~~data,~~outside ~~such~~the United ~~as animal and laboratory testing results~~States, ~~showing~~we itexpect ~~is safe~~ to ~~test~~face ~~the~~comparable ~~device~~international inregulatory ~~humans and that the testing protocol is scientifically sound~~oversight. The ~~IDE~~U.S. ~~must~~regulatory bejurisdiction ~~approved in advance by the FDA~~ for aextracorporeal ~~specific number of patients~~blood atpurification ~~specified~~therapies ~~study~~is ~~sites. During~~ the ~~trial,~~Center ~~the sponsor must comply with the FDA’s IDE requirements~~ for ~~investigator~~Devices ~~selection, trial monitoring, reporting~~ and ~~record~~Radiological ~~keeping.~~Health ~~The investigators must obtain patient informed consent~~(“CDRH”), ~~rigorously follow~~ the investigational plan and study protocol, control the disposition of investigational devices and comply with all reporting and record keeping requirements. Clinical trials for Class III devices may not begin until the IDE application is approved by the FDA ~~and~~branch ~~the appropriate institutional review boards, or IRBs, at the clinical trial sites. An IRB is an appropriately constituted group~~ that ~~has~~oversees ~~been formally designated to review and monitor medical research involving subjects and which has~~ the ~~authority to approve, require modifications in, or disapprove~~market ~~research to protect the rights, safety and welfare of human research subjects. The FDA or the IRB at each site at which a clinical trial is being performed may withdraw~~ approval of amedical clinical trial at any time for various reasons, including a belief that the risks to study subjects outweigh the benefits or a failure to comply with FDA or IRB requirements. Even if a trial is completed, there is no assurance that clinical testing will demonstrate the safety and effectiveness of Sigyn Therapy or other pipeline devices.

37Based on published CDRH guidance, we believe that each of our therapeutic candidates will be classified as Class III medical devices that are subject to a Pre-Market Approval (“PMA”) submission pathway. A PMA pathway requires extensive data, including but not limited to technical documents, preclinical studies, animal studies, human clinical trials, the establishment of Current Good Manufacturing Practices (“cGMPs”) standards and labelling that fulfils FDA’s requirement to demonstrate reasonable evidence of safety and effectiveness of a medical device product. However, as our therapeutic candidates do not emit electronic product radiation, they will not be subject to regulatory challenges associated with medical devices that emit electronic radiation.

~~Manufacturing and Procurement~~36

AtThe commercialization ~~present~~of medical devices in the United States requires either a prior 510(k) clearance, weunless ~~plan~~it tois ~~manufacture~~exempt, or a PMA from ~~Sigyn~~the ~~Therapy~~FDA. ~~and~~Generally, ~~other~~if ~~candidate~~a ~~products~~new ~~through~~device ~~contracts~~has ~~with~~a ~~FDA~~predicate ~~registered~~that ~~Contract~~is ~~Manufacturing~~already ~~Organizations~~on the market under a 510(~~CMO~~k) clearance, the FDA will allow that new device to ~~establish~~be marketed under a 510(k) clearance; otherwise, a premarket approval, or PMA, is required. Medical devices are classified ~~cGMPs~~into ~~compliant~~one ~~manufacturing~~of three classes; Class I, Class II or Class III which are determined by the degree of risk associated with each medical device and the extent of control needed to ~~support~~provide ~~human~~reasonable ~~clinical~~assurance ~~studies~~of safety and ~~potential~~effectiveness. ~~commercialization~~Class ~~should~~I wedevices ~~receive~~are ~~clearance~~deemed ~~from~~to ~~FDA~~be low risk and are subject to the general controls of the Federal Food, Drug and Cosmetic Act, such as provisions that relate to: adulteration; ~~market~~misbranding; ~~one~~registration and listing; notification, including repair, replacement, or ~~more~~refund; records and reports; and good manufacturing practices. Most Class I devices are classified as exempt from pre-market notification under section 510(k) of ~~our~~the ~~products~~FD&C Act, and therefore may be commercially distributed without obtaining 510(k) clearance from the FDA. WeClass ~~plan~~II devices are subject to ~~establish~~both ~~manufacturing~~general ~~procedure~~controls and ~~specifications~~special ~~that~~controls ~~define~~to ~~each~~provide ~~stage~~reasonable assurance of ~~our~~safety ~~manufacturing~~and effectiveness. Special controls include performance standards, post ~~inspection~~market ~~and~~surveillance, ~~testing~~patient ~~processes~~registries and guidance documents. A manufacturer may be required to submit to the ~~control~~FDA ~~parameters~~a pre-market notification requesting permission to commercially distribute some Class II devices. Devices deemed by the FDA to pose the greatest risk, such as life-sustaining, life-supporting or ~~acceptance~~implantable ~~criteria~~devices, ~~that~~or ~~apply~~devices deemed not substantially equivalent to ~~each~~a ~~activity~~previously ~~that~~cleared ~~result~~510(k) device, are placed in Class III. A Class III device cannot be marketed in the ~~production~~United States unless the FDA approves the device after submission of a PMA. We believe that all of our ~~technologies~~therapeutic candidates will be classified as a Class III device and as such will be subject to a PMA submission and approval.

WeShould Sigyn ~~have~~Therapy ~~also~~or ~~established relationships~~any of our other therapeutic candidates receive market clearance from FDA, we would need to comply with ~~industry~~applicable ~~vendors~~laws and regulations that ~~provide~~govern ~~components~~the ~~necessary~~development, totesting, ~~manufacture~~manufacturing, ~~Sigyn~~labeling, ~~Therapy~~marketing, storage, distribution, advertising and promotion, and post-marketing surveillance reporting for medical devices. ~~Should~~Failure ~~the~~to ~~relationship~~comply with anthese ~~industry vendor~~applicable berequirements ~~interrupted~~may subject a device and/or ~~discontinued,~~its wemanufacturer ~~believe~~to ~~that~~a ~~alternate~~variety ~~component~~of ~~suppliers~~administrative ~~can~~sanctions, besuch ~~identified~~as toissuance ~~support~~of ~~continued~~warning ~~manufacturing.~~letters, import detentions, civil monetary ~~However~~penalties and/or judicial sanctions, ~~delays~~such ~~related~~as product seizures, injunctions and criminal prosecution. Our failure to ~~interrupted~~comply orwith ~~discontinued~~any ~~vendor~~of these ~~relationships~~laws and regulations could ~~adversely~~have ~~impact~~a material adverse effect on our ~~business~~operations.

~~Research~~The Pre-market ~~and~~Approval ~~Product Development~~Pathway

~~To date, we have outsourced~~A ~~our research and product development activities, which include the performance of in vitro blood plasma validation studies, animal studies,~~ pre-~~cGMPs~~market ~~product~~approval assembly and manufacturing through third party organizations with experience in advancing extracorporeal blood purification technologies. Our pre-clinical in vitro blood plasma studies we each performed under an agreement with Innovative BioTherapies, Inc. (~~IBT~~“PMA”) ~~and~~application ~~our~~must ~~animal~~be ~~clinical~~submitted ~~studies~~to ~~were~~FDA ~~conducted~~for byClass ~~IBT~~III ~~team~~devices ~~members~~requiring ~~through~~ a ~~contract~~PMA. ~~with~~The ~~the~~PMA ~~University of~~application ~~Michigan~~process tois ~~utilize~~more ~~animal~~demanding ~~care,~~than ~~associated institutional review oversight, as well as surgical suite facilities located within~~ the ~~North Campus~~510(k)-pre-market ~~Research~~notification ~~Complex~~process. ~~While~~A wePMA ~~maintain~~application ~~ownership~~must ~~rights~~be tosupported ~~all~~by ~~study~~extensive data ~~collected by IBT~~, weincluding but donot ~~permit~~limited ~~for IBT~~ to ~~publish~~technical, orpreclinical, ~~present the~~clinical ~~results of our contracted studies. At present~~trials, wemanufacturing doand ~~not~~labeling ~~have~~to ~~plans~~demonstrate to ~~build~~the ~~and~~FDA’s ~~staff~~satisfaction reasonable ~~our~~evidence ~~own~~of ~~research~~safety and ~~product~~effectiveness ~~development~~of ~~facility~~the device.

~~Competition~~After a PMA application is submitted, the FDA has 45 days to determine whether the application is sufficiently complete to permit a substantive review and thus whether the FDA will file the application for review. The FDA has 180 days to review a filed PMA application, although the review of an application generally occurs over a significantly longer period of time and can take up to several years. During this review period, the FDA may request additional information or clarification of the information already provided. Also, an advisory panel of experts from outside the FDA may be convened to review and evaluate the application and provide recommendations to the FDA as to the approvability of the device.

~~Our therapeutic candidates~~Although ~~provide~~the aFDA ~~novel~~is ~~approach and are~~ not ~~similar~~bound toby ~~other~~the ~~products~~advisory inpanel decision, the ~~marketplace.~~panel’s ~~However,~~recommendations ~~there~~ are ~~there~~important ~~may~~to bethe ~~medical~~FDA ~~device~~decision ormaking ~~pharmaceutics~~process. ~~companies~~In ~~that~~addition, the FDA may ~~develop~~conduct ~~products~~a ~~that~~preapproval ~~could~~inspection ~~compete~~of ~~directly~~the ~~with~~manufacturing ~~our~~facility ~~therapeutic~~to ~~candidates.~~ensure Ifcompliance ~~these~~with ~~companies~~the ~~develop~~Quality ~~competing~~System ~~products~~Regulation, ~~they~~or ~~have~~QSR. ~~far~~The ~~greater~~agency ~~resources~~also tomay ~~support~~inspect ~~the~~one ~~clinical~~or ~~advancement~~more ~~and~~clinical ~~post~~sites ~~approval~~to ~~marketing~~assure ofcompliance ~~their~~with ~~products~~FDA’s ~~within the medical industry than we do~~regulations.

~~Environmental~~Upon completion ~~Laws~~of the PMA review, the FDA may: (i) approve the PMA which authorizes commercial marketing with specific prescribing information for one or more indications, which can be more limited than those originally sought; (ii) issue an approvable letter which indicates the FDA’s belief that the PMA is approvable and states what additional information the FDA requires, or the post-approval commitments ~~Regulations~~that must be agreed to prior to approval; (iii) issue a not approvable letter which outlines steps required for approval, but which are typically more onerous than those in an approvable letter, and may require additional clinical trials that are often expensive and time consuming and can delay approval for months or even years; or (iv) deny the application. If the FDA issues an approvable or not approvable letter, the applicant has 180 days to respond, after which the FDA’s review clock is reset.

~~At present, our operations are not subject to any environmental laws or regulations~~37

~~Overview of Presentation~~Clinical Trials

Clinical trials are almost always required to support PMA market clearance and are sometimes required for 510(k) clearance. In the United States, for significant risk Class III devices, these trials require submission of an Investigational Device Exemption (IDE) application to the FDA. The ~~following~~IDE ~~Management~~application must be supported by appropriate data, such as animal and laboratory testing results, showing it is safe to test the device in humans and that the testing protocol is scientifically sound. The IDE must be approved in advance by the FDA for a specific number of patients at specified study sites. During the trial, the sponsor must comply with the FDA’s ~~Discussion~~IDE requirements for investigator selection, trial monitoring, reporting and ~~Analysis~~record keeping. The investigators must obtain patient informed consent, rigorously ~~(“MD&A”)~~follow the investigational plan and study protocol, control the disposition of investigational devices and comply with all reporting and record keeping requirements. Clinical trials for Class III devices may not begin until the IDE application is approved by the FDA and the appropriate institutional review boards, or ~~Plan~~IRBs, at the clinical trial sites. An IRB is an appropriately constituted group that has been formally designated to review and monitor medical research involving subjects and which has the authority to approve, require modifications in, or disapprove research to protect the rights, safety and welfare of ~~Operations~~human ~~includes~~research subjects. The FDA or the ~~following~~IRB ~~sections:~~at each site at which a clinical trial is being performed may withdraw approval of a clinical trial at any time for various reasons, including a belief that the risks to study subjects outweigh the benefits or a failure to comply with FDA or IRB requirements. Even if a trial is completed, there is no assurance that clinical testing will demonstrate the safety and effectiveness of Sigyn Therapy or other pipeline devices.

~~● Results of Operations ● Liquidity~~ Manufacturing and ~~Capital Resources ● Capital Expenditures ● Going Concern ● Critical Accounting Policies ● Off-Balance Sheet Arrangements~~Procurement

38At present, we plan to manufacture Sigyn Therapy and other candidate products through contracts with FDA registered Contract Manufacturing Organizations (CMO) to establish cGMPs compliant manufacturing to support human clinical studies and potential commercialization should we receive clearance from FDA to market one or more of our products. We plan to establish manufacturing procedure specifications that define each stage of our manufacturing, inspection and testing processes and the control parameters or acceptance criteria that apply to each activity that result in the production of our technologies.

~~General~~We have ~~and~~also ~~administrative~~established ~~expenses~~relationships ~~consist~~with ~~primarily~~industry vendors that provide components necessary to manufacture Sigyn Therapy. Should the ofrelationship ~~personnel~~with ~~costs~~an ~~and~~industry ~~professional~~vendor ~~fees~~be ~~required~~interrupted or discontinued, we believe that alternate component suppliers can be identified to support ~~our~~continued ~~operations~~manufacturing. ~~and~~However, ~~growth~~delays related to interrupted or discontinued vendor relationships could adversely impact our business.

~~Depending on the extent of our future growth, we may~~Research ~~experience significant strain on our management, personnel,~~ and ~~information~~Product systems. We will need to implement and improve operational, financial, and management information systems. In addition, we are implementing new information systems that will provide better record-keeping, customer service and billing. However, there can be no assurance that our management resources or information systems will be sufficient to manage any future growth in our business, and the failure to do so could have a material adverse effect on our business, results of operations and financial condition.Development

~~Results~~To date, we have outsourced much of ~~Operations~~our research and product development activities, which include the performance of in vitro blood plasma validation studies, animal studies, pre-cGMPs product assembly and manufacturing through third party organizations with experience in advancing extracorporeal blood purification technologies. Our pre-clinical in vitro blood plasma studies we each performed under an agreement with Innovative BioTherapies, Inc. (IBT) and our animal clinical studies were conducted by IBT team members through a contract with the University of Michigan to utilize animal care, associated institutional review oversight, as well as surgical suite facilities located within the North Campus Research Complex. While we maintain ownership rights to all study data collected by IBT, we do permit for IBT to publish or present the results of our contracted studies. At present, we do not have plans to build our own research and product development facility.

~~Three Months Ended March 31, 2025 Compared to Three Months Ended March 31, 2024~~Competition

~~The~~Our therapeutic ~~following~~candidates ~~discussion~~provide ~~represents~~ a ~~comparison~~novel ~~of our~~approach ~~results~~and ofare ~~operations~~not ~~for~~similar ~~the~~to ~~three~~other ~~months~~products ~~ended~~in ~~March~~the ~~31, 2025 and 2024~~marketplace. ~~The~~However, ~~results~~there ofare ~~operations~~there ~~for~~may be ~~the~~medical ~~periods~~device ~~shown~~or inpharmaceutics ~~our~~companies ~~audited condensed~~that ~~consolidated~~may ~~financial~~develop ~~statements~~products ~~are~~that ~~not~~could ~~necessarily~~compete ~~indicative~~directly ofwith ~~operating~~our ~~results~~therapeutic ~~for the entire period~~candidates. ~~In the opinion~~If ofthese ~~management,~~companies ~~the~~develop ~~audited~~competing ~~condensed~~products, ~~consolidated~~they ~~financial~~have ~~statements~~far ~~recognize~~greater ~~all~~resources ~~adjustments of a normal recurring nature considered necessary~~ to ~~fairly~~support ~~state~~the ~~our~~clinical ~~financial~~advancement ~~position,~~and ~~results~~post approval marketing of ~~operations~~their ~~and~~products ~~cash~~within ~~flows~~the ~~for~~medical ~~the~~industry ~~periods~~than ~~presented~~we do.

	Three Months Ended March 31,
	2025			2024
Net revenues	$	-		$	-
Cost of sales		-			-
Gross Profit		-			-
Operating expenses		546,059			629,972
Other expense		122,505			128,116
Net loss before income taxes	$	(668,564	)	$	(758,088	)

~~Net~~Environmental Laws ~~Revenues~~and Regulations

~~For~~At present, ~~the~~our ~~three~~operations ~~months~~are ~~ended~~not ~~March~~subject ~~31,~~to ~~2025~~any ~~and~~environmental ~~2024, we~~laws ~~had~~or ~~no revenues.~~regulations

~~Cost~~ Overview of ~~Sales~~Presentation

~~For~~The following ~~the~~Management’s ~~three~~Discussion ~~months ended March 31, 2025~~ and ~~2024, we~~Analysis ~~had~~(“MD&A”) noor ~~cost~~Plan of ~~sales~~Operations asincludes wethe ~~had~~following ~~no revenues.~~sections:

~~Operating~~● ~~expenses~~Results of Operations ● Liquidity and Capital Resources ● Capital Expenditures ● Going Concern ● Critical Accounting Policies ● Off-Balance Sheet Arrangements

~~Operating expenses decreased by $83,913, or 13.3%,~~General toand ~~$546,059~~administrative ~~for~~expenses ~~three~~consist ~~months ended March 31, 2025 from $629,972 for the three months ended March 31, 2024~~ primarily ~~due to decreases in research and development costs~~ of ~~$223,751,~~personnel ~~insurance~~ costs ~~of $45,541, marketing costs of $162, depreciation costs of $160,~~ and ~~general and administration costs of $3,718, offset primarily by increases in compensation costs of $157,066, investor relations costs of $622, consulting fees of $14,875,~~ professional fees ofrequired ~~$4,357,~~to ~~and~~support ~~stock based compensation of $12,500, as a result of adding administrative infrastructure for~~ our ~~anticipated~~operations ~~business~~and ~~development~~growth.

~~For~~Depending on the ~~three~~extent ~~months~~of ~~ended~~our ~~March~~future 31growth, ~~2025,~~ we ~~had marketing~~may ~~expenses~~experience ofsignificant ~~$176~~strain on our management, ~~research~~personnel, and ~~development~~information ~~costs~~systems. ofWe ~~$8,842,~~will need ~~stock~~to ~~based~~implement ~~compensation~~and ofimprove ~~$50~~operational,~~000~~ financial, and ~~general~~management ~~and~~information ~~administrative expenses~~systems. ofIn ~~$487~~addition,~~041~~ ~~primarily~~we ~~due~~are toimplementing ~~professional~~new ~~fees~~information systems ofthat ~~$49~~will provide better record-keeping,~~761,~~ ~~compensation~~customer ~~costs~~service ofand ~~$335~~billing. However,~~176,~~ ~~rent~~there ~~expense~~can ofbe ~~$19,480,~~no ~~depreciation~~assurance that our management ~~costs~~resources ofor ~~$1,363,~~information ~~investor~~systems ~~relations~~will ~~costs~~be ofsufficient ~~$13,353,~~to ~~consulting~~manage ~~fees~~any offuture ~~$37,375,~~growth ~~insurance~~in ~~expense of~~our ~~$26~~business,~~795,~~ and ~~general~~the ~~and~~failure ~~administration~~to ~~costs~~do ofso ~~$3,738,~~could as have a ~~result~~material ofadverse ~~adding~~effect ~~administrative~~on ~~infrastructure~~our ~~for~~business, ~~our~~results ~~anticipated~~of ~~business development~~operations and financial condition.

39Results of Operations

~~For the three months ended March 31, 2024, we had~~Three ~~marketing~~Months ~~expenses~~Ended ofJune ~~$338~~30, ~~research~~2025 ~~and~~Compared ~~development costs of $232,593, stock based compensation of $37,500, and general and administrative expenses of $359,541 primarily due~~ to ~~professional~~Three ~~fees~~Months ofEnded ~~$45,404,~~June ~~compensation costs of $178~~30,~~110,~~ rent expense of $19,481, depreciation costs of $1,523, investor relations costs of $12,731, consulting fees of $22,500, insurance expense of $72,336, and general and administration costs of $7,455, as a result of adding administrative infrastructure for our anticipated business development.2024

~~Other~~The following ~~Expense~~discussion represents a comparison of our results of operations for the three months ended June 30, 2025 and 2024. The results of operations for the periods shown in our audited condensed consolidated financial statements are not necessarily indicative of operating results for the entire period. In the opinion of management, the audited condensed consolidated financial statements recognize all adjustments of a normal recurring nature considered necessary to fairly state our financial position, results of operations and cash flows for the periods presented.

Other expense for the three months ended March 31, 2025 totaled $122,505 primarily due to interest expense of $27,704 in conjunction with accretion of debt discount, interest expense of $94,353 in conjunction with accretion of original issuance discount, and interest expense of $448, compared to other expense of $128,116 for the three months ended March 31, 2024 primarily due to interest expense of $43,207 in conjunction with accretion of debt discount, interest expense of $83,399 in conjunction with accretion of original issuance discount, and interest expense of $1,510.

	Three Months Ended June 30,
	2025			2024

Net revenues	$	-		$	-
Cost of sales		-			-
Gross Profit		-			-
Operating expenses		469,513			602,805
Other expense		981,674			259,578
Net loss before income taxes	$	(1,451,187	)	$	(862,383	)

~~Net loss before income taxes~~39

Net ~~loss before income taxes for the three months~~ ended March 31, 2025 totaled $668,564 primarily due to (increases/decreases) in compensation costs, professional fees, marketing costs, investor relations costs, consulting fees, research and development costs, rent, insurance, stock based compensation, and general and administration costs compared to a loss of $758,008 for the three months ended March 31, 2024 primarily due to (increases/decreases) in compensation costs, professional fees, marketing costs, investor relations costs, consulting fees, research and development costs, rent, insurance, stock based compensation, and general and administration costs.Revenues

~~Assets~~For the three months ended June 30, 2025 and ~~Liabilities~~2024, we had no revenues.

~~Assets were $244,309 as of March 31, 2025. Assets~~Cost ~~consisted primarily~~ of cash of $12,895, other current assets of $55,200, equipment of $8,322, operating lease right-of-use assets of $97,181, and other assets of $70,711. Liabilities were $5,189,516 as of March 31, 2025. Liabilities consisted primarily of accounts payable of $672,040, accrued payroll and payroll taxes of $2,005,147, other current liabilities of $312, convertible notes of $2,189,296, net of $212,409 of unamortized debt discount and debt issuance costs, short term promissory notes of $212,920, net of $101,080 of unamortized debt discount and debt issuance costs, and operating lease liabilities of $109,801.Sales

~~Liquidity~~For the three months ended June 30, 2025 and ~~Capital~~2024, ~~Resources~~we had no cost of sales as we had no revenues.

~~Going Concern~~Operating expenses

~~The~~Operating expenses ~~accompanying~~decreased ~~financial~~by ~~statements~~$133,292, ~~have~~or ~~been~~22.1%, ~~prepared assuming~~to ~~the~~$469,513 ~~Company~~for ~~will~~three ~~continue~~months asended aJune ~~going concern~~30, ~~which~~2025 ~~contemplates,~~from ~~among other things~~$602,805 for the ~~realization~~three ofmonths ~~assets~~ended ~~and satisfaction~~June of30, ~~liabilities~~2024 inprimarily ~~the~~due ~~normal~~to ~~course~~decreases ofin ~~business.~~research ~~The~~and ~~Company~~development ~~had~~costs ~~an accumulated deficit~~ of $15232,~~350~~947,~~288~~ atdepreciation ~~March~~costs ~~31,~~of ~~2025~~$1,364, ~~had~~rent aexpense ~~working capital deficit~~ of $512,~~083~~460,~~920~~ professional ~~and~~fees of $416,~~593~~961,~~743~~ atinvestor ~~March~~relations ~~31,~~costs ~~2025~~of ~~and December 31~~$3, ~~2024~~347, ~~respectively,~~and ~~had~~general aand ~~net~~administration ~~loss~~costs of $~~668~~455,~~564~~ ~~and~~offset ~~$758,088 for~~primarily ~~the~~by ~~three~~increases in ~~months~~compensation ~~ended~~costs ~~March~~of 31$85,576, ~~2025~~consulting ~~and~~fees ~~2024,~~of ~~respectively~~$29,835, ~~and~~insurance ~~net~~costs ~~cash used in operating activities~~ of $~~294~~5,~~446 and $235~~386,~~612~~ ~~for the~~travel ~~three~~costs ~~months~~of ~~ended March 31~~$945, ~~2025~~ and ~~2024,~~stock ~~respectively,~~based ~~with~~compensation of ~~no revenue earned since inception~~$12,500, ~~and~~as a ~~lack~~result of ~~operational~~adding ~~history. These~~administrative ~~matters~~infrastructure ~~raise~~for ~~substantial~~our ~~doubt~~anticipated ~~about~~business ~~the Company’s ability to continue as a going concern~~development.

~~While~~ For the ~~Company~~three ismonths ~~attempting~~ended toJune ~~expand~~30, ~~operations and increase revenues~~2025, ~~the~~we ~~Company’s~~had ~~cash~~marketing ~~position~~expenses ~~may~~of ~~not~~$8, beresearch ~~significant~~and ~~enough~~development tocosts ~~support~~of ~~the~~$7,482, ~~Company’s~~stock ~~daily~~based ~~operations.~~compensation ~~Management~~of ~~intends~~$50,000, toand ~~raise~~general ~~additional~~and ~~funds~~administrative byexpenses ~~way~~ of a$412,023 ~~public~~primarily ~~offering~~due ~~or an asset sale transaction. Management believes that the actions presently being taken~~ to ~~further~~professional ~~implement~~fees ~~its~~of ~~business~~$16,949, ~~plan~~compensation ~~and~~costs ~~generate revenues provide the opportunity for the Company to continue~~of as$265,423, arent ~~going~~expense ~~concern.~~of ~~While~~$6,832, ~~management~~investor ~~believes~~relations incosts ~~the viability~~ of ~~its~~$6,456, ~~strategy~~consulting tofees ~~generate~~of ~~revenues~~$63,335, ~~and~~insurance inexpense ~~its~~of ~~ability~~$49,987, ~~to raise additional~~travel ~~funds~~costs orof ~~transact an asset sale~~$945, ~~there~~and ~~can~~general beand noadministration ~~assurances~~costs ~~to that effect or on terms acceptable to the Company. The ability~~ of ~~the~~$2,096, ~~Company to continue~~ as a ~~going~~result ~~concern~~of isadding ~~dependent~~administrative ~~upon~~infrastructure ~~the~~for ~~Company’s~~our ~~ability to further implement its~~ anticipated business ~~plan and generate revenues~~development.

40For the three months ended June 30, 2024, we had marketing expenses of $8, research and development costs of $240,429, stock based compensation of $37,500, and general and administrative expenses of $324,868 primarily due to professional fees of $33,910, compensation costs of $179,847, rent expense of $19,292, depreciation costs of $1,364, investor relations costs of $9,803, consulting fees of $33,500, insurance expense of $44,601, and general and administration costs of $2,551, as a result of adding administrative infrastructure for our anticipated business development.

~~The condensed consolidated financial statements do~~Other ~~not include any adjustments that might be necessary if we are unable to continue as a going concern.~~Expense

~~General~~Other expense –for ~~Overall~~the three months ended June 30, we2025 ~~had~~totaled an$981,674 ~~increase~~primarily due to interest expense of $42,175 in conjunction with accretion of debt discount, interest expense of $81,017 in ~~cash~~conjunction ~~flows~~with ~~for~~accretion ~~the~~of ~~three~~original ~~months~~issuance ~~ended~~discount, ~~March~~interest 31expense of $873, modification ~~2025~~of warrants of $~~751~~17,505, ~~resulting~~inducement ~~from~~of ~~cash~~preferred ~~provided~~shares byof ~~financing~~$845,901, ~~activities~~and other income of $~~295~~5,~~197~~797, ~~offset~~compared to other expense ~~partially~~of by$259,578 ~~cash~~primarily ~~used~~due to interest expense of $116,737 in ~~operating~~conjunction ~~activities~~with accretion of debt discount, interest expense of $~~294~~142,~~446~~272 in conjunction with accretion of original issuance discount, and interest expense of $569.

~~The following is a summary of our cash flows provided~~Net byloss ~~(used~~before ~~in)~~income ~~operating, investing, and financing activities during the periods indicated:~~taxes

	Three Months Ended March 31,
	2025			2024
Net cash provided by (used in):
Operating activities	$	(294,446	)	$	(235,612	)
Investing activities		-			-
Financing activities		295,197			256,760
	$	751		$	21,148

Net loss before income taxes for the three months ended June 30, 2025 totaled $1,451,187 primarily due to increases in compensation costs, travel costs, insurance expense, consulting fees, and stock based compensation, offset primarily by decreases in research and development costs, investor relations costs, professional fees, rent, depreciation, and general and administration costs compared to a loss of $862,383 for the three months ended June 30, 2024 primarily due to increases in compensation costs, professional fees, investor relations costs, and research and development costs, offset primarily by decreases in marketing costs, consulting fees, rent, insurance, depreciation, amortization, and general and administration costs.

~~Cash Flows from Operating Activities~~Assets – For the three months ended March 31, 2025, net cash used in operations was $294,446 compared to net cash used in operations of $235,612 for the three months ended March 31, 2024. Net cash used in operations was primarily due to a net loss of $668,564 for three months ended March 31, 2025 and the changes in operating assets and liabilities of $200,698, primarily due to the changes in accounts payable of $63,656, other current assets of $3,900, accrued payroll and payroll taxes of $136,174, offset partially by the change in other current liabilities of $3,032. In addition, net cash used in operating activities includes adjustments to reconcile net profit from depreciation expense of $1,363, stock based compensation of $50,000, accretion of original issuance costs of $94,353, and the accretion of debt discount of $27,704.Liabilities

~~For~~Assets were ~~the~~$51,759 ~~three~~as ~~months~~of ~~ended~~June ~~March 31~~30, ~~2024,~~2025. ~~net~~Assets ~~cash used~~consisted inprimarily ~~operations~~of ~~was~~cash ~~primarily~~of ~~due~~$459, toother acurrent ~~net~~assets ~~loss~~ of $~~758~~1,~~088~~300, and ~~the~~other ~~changes in operating~~ assets ~~and~~of ~~liabilities~~$50,000. Liabilities ofwere $~~356~~5,~~847~~489,388 ~~primarily due~~as toof ~~the~~June ~~changes~~30, in2025. ~~accounts~~Liabilities ~~payable~~consisted primarily of ~~$67,804,~~accounts ~~other~~payable ~~current assets~~ of $4729,~~783~~846, ~~and~~ accrued payroll and payroll taxes of $~~285~~2,~~908~~186, ~~offset~~086, ~~partially by the change in~~ other current liabilities of $13,~~648.~~408, Inconvertible ~~addition~~notes of $2,307,986, net ~~cash~~of ~~used~~$181,719 inof ~~operating~~unamortized ~~activities includes adjustments~~debt todiscount ~~reconcile~~and ~~net~~debt ~~profit~~issuance ~~from~~costs, ~~depreciation~~and ~~expense~~short ofterm ~~$1,523,~~promissory ~~stock~~notes ~~based compensation~~ of $37262,~~500~~062, ~~accretion~~net of ~~original issuance costs of~~ $8361,~~399,~~938 ~~and the accretion~~ of unamortized debt discount ofand ~~$43,207~~debt issuance costs.

~~Cash Flows from Investing Activities – For the three months ended March 31, 2025 and 2024, the Company had no cash flows from investing activities.~~40

~~Cash Flows from Financing Activities~~Six –Months ~~For~~Ended ~~the~~June ~~three months ended March 31~~30, 2025, ~~net~~Compared ~~cash provided by financing was $295,197, due~~ to ~~proceeds~~Six ~~from~~Months ~~short~~Ended ~~term~~June ~~convertible notes of $295~~30,~~197~~ ~~compared to cash provided by financing activities of $256,760 for the three months ended March 31,~~ 2024 ~~due to proceeds from short term convertible notes of $251,760 and advance from shareholder of $25,000, and repayments of advance from shareholder of $20,000.~~

~~Financing~~The following –discussion Werepresents ~~expect~~a ~~that~~comparison of our ~~current~~ ~~working~~results ~~capital~~of ~~position,~~operations ~~together~~for ~~with~~the ~~our~~six ~~expected~~months ~~future~~ended ~~cash~~June ~~flows~~30, ~~from~~2024 ~~operations~~and ~~will~~2023. beThe ~~insufficient~~results of ~~to fund our~~ operations in for the ~~ordinary~~periods ~~course~~shown ofin ~~business,~~our ~~anticipated~~audited ~~capital~~condensed ~~expenditures,~~consolidated ~~debt~~financial ~~payment~~statements ~~requirements~~are ~~and~~not ~~other~~necessarily ~~contractual~~indicative ~~obligations~~of ~~for~~operating atresults ~~least~~for the ~~next~~entire ~~twelve months~~period. AsIn ~~stated~~the ~~above~~opinion of management, ~~Management~~the ~~intends~~audited tocondensed ~~raise~~consolidated ~~additional~~financial ~~funds~~statements byrecognize ~~way~~all adjustments of a ~~public~~normal ~~offering~~recurring ornature anconsidered ~~asset sale~~necessary ~~transaction,~~to ~~however~~fairly ~~there~~state ~~can~~our befinancial noposition, ~~assurance~~results ~~that~~of weoperations ~~will~~and becash ~~successful~~flows infor ~~completing~~the periods ~~such transactions~~presented.

We have no present agreements or commitments with respect to any material acquisitions of other businesses, products, product rights or technologies or any other material capital expenditures. However, we will continue to evaluate acquisitions of and/or investments in products, technologies, capital equipment or improvements or companies that complement our business and may make such acquisitions and/or investments in the future. Accordingly, we may need to obtain additional sources of capital in the future to finance any such acquisitions and/or investments. We may not be able to obtain such financing on commercially reasonable terms, if at all. Due to the ongoing global economic crisis, we believe it may be difficult to obtain additional financing if needed. Even if we are able to obtain additional financing, it may contain undue restrictions on our operations, in the case of debt financing, or cause substantial dilution for our stockholders, in the case of equity financing.

	Six Months Ended June 30,
	2025			2024

Net revenues	$	-		$	-
Cost of sales		-			-
Gross Profit		-			-
Operating expenses		1,015,572			1,232,774
Other expense		1,104,179			387,697
Net loss before income taxes	$	(2,119,751	)	$	(1,620,471	)

41Net Revenues

~~Regulation~~For the Dsix months ended June 30, 2024 and 2023, we had no revenues.

~~On January 9, 2025, the Company initiated a Regulation~~Cost ~~D offering to sell up to 750,000 Units at a price~~ of $5,000 per unit with each Unit consisting of one (1) $5,500 principal amount convertible debenture (convertible at Four dollars ($4.00) per share into the Company’s common stock) and a Warrant to purchase 1,250 shares of common stock at $6.00 per share. The Debentures have a principal amount equal to 110% of such Purchaser’s subscription amount, convertible at $4.00 per share and maturing one (1) year from the date the subscription amount is accepted by the Company. The Warrants for a number of shares equal to the subscription amount divided by the conversion price with an exercise price of $6.00 per share, exercisable upon issuance and will expire five years from issuance. The Debentures will not be redeemable but contain an automatic conversion feature, which will cause all principal and interest due under the Debenture to automatically convert if our common stock is listed for trading on a national securities exchange, such as NASDAQ or the NYSE. As of March 31, 2025, a total of 69 Units were sold to accredited investors at a price of $5,500 per Unit totaling $379,717 (total of $295,197 cash was received and $50,000 as a subscription receivable).Sales

~~Convertible~~For the ~~Notes~~six ~~Payable~~months ended June 30, 2024 and 2023, we had no cost of sales as we had no revenues.

~~During~~Operating fiscal 2025 and 2024, the Company entered into Original Issue Discount Senior Convertible Debentures (the “2024 Notes”) totaling (i) $912,029 aggregate principal amount of Notes (total of $825,890 cash was received) due between January and November 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 228,008 shares of the Company’s Common Stock at an exercise price of $6.00 per share. The aggregate cash subscription amount received by the Company for the issuance of the Note and Warrants was $825,890 which was issued at a $86,139 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.expenses

InOperating expenses ~~September~~decreased by $217,202, or 17.6%, to $1,015,572 for six months ended June 30, 2025 from $1,232,774 for the six months ended June 30, 2024 primarily due to decreases in research and development costs of $456,699, ~~holders~~investor ~~converted~~relations costs of $~~474~~2,~~793~~725, insurance costs of $40,155, marketing costs of $162, rent of $12,460, professional fees of $12,604, depreciation costs of $1,522, and general and administration costs of $4,170, offset primarily by increases in ~~exchange~~consulting fees of $44,710, compensation costs of $242,640, stock based compensation ~~for~~of ~~the~~$25,000, ~~issuance~~and travel costs of ~~118~~$945,~~700~~ ~~shares~~as a result of ~~Common~~adding ~~Stock~~administrative toinfrastructure ~~the~~for ~~holders~~our anticipated business development.

InFor the ~~May~~six ~~and~~months ended June ~~2024~~30, ~~holders~~2025, ~~converted~~we had marketing expenses of $~~232~~184,~~937~~ ~~in exchange~~research ~~for~~and ~~the~~development ~~issuance~~costs of 38$16,~~826~~323, ~~shares~~stock based compensation of ~~Common~~$100,000, ~~Stock~~and general and administrative expenses of $899,065 primarily due to ~~the~~professional ~~holders~~fees of $66,710, compensation costs of $600,598, rent expense of $26,313, depreciation costs of $1,363, investor relations costs of $19,809, consulting fees of $100,710, insurance expense of $76,783, travel costs of $945, and general and administration costs of $5,834, as a result of adding administrative infrastructure for our anticipated business development.

OnFor the ~~April~~six 10months ended June 30, 2024, ~~Osher~~we ~~elected~~had tomarketing ~~exchange~~expenses of $~~621~~346,~~000 of~~ ~~Notes~~research ~~for~~and andevelopment ~~aggregate~~costs of ~~823.86~~$473,022, ~~shares~~stock based compensation of ~~Series~~$75,000, Band ~~Convertible~~general ~~Preferred~~and ~~Stock.~~administrative ~~Each~~expenses ~~Series~~of B$684,406 ~~Convertible~~primarily ~~Preferred~~due ~~Share~~to ~~converts into~~professional ~~125.63~~fees ~~shares~~of $79,314, compensation costs of $357,958, ~~the~~rent ~~Company’s~~expense ~~common~~of ~~stock~~$38,773, ~~subject~~depreciation tocosts ~~antidilution~~of ~~adjustments~~$2,885, ~~for~~investor ~~any~~relations ~~stock~~costs ~~splits~~of ~~and~~$22,534, ~~recapitalizations~~consulting fees of $56,000, insurance expense of $116,938, and ~~for~~general ~~issuances~~and ofadministration ~~additional~~costs ~~shares~~of at$10,004, anas ~~issue~~a ~~price~~result of ~~less~~adding ~~than~~administrative ~~the~~infrastructure ~~conversion~~for ~~ratio~~our anticipated business development.

~~On April 9, 2024, Brio elected to exchange $220,420~~Other 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.Expense

~~Capital~~Other expense ~~Expenditures~~for the six months ended June 30, 2025 totaled $1,104,179 primarily due to interest expense of $69,879 in conjunction with accretion of debt discount, interest expense of $175,370 in conjunction with accretion of original issuance discount, and interest expense of $1,321, modification of warrants of $17,505, inducement of preferred shares of $845,901, and other income of $5,797, compared to other expense of $387,697 for the six months ended June 30, 2024 primarily due to interest expense of $159,944 in conjunction with accretion of debt discount, interest expense of 225,672 in conjunction with accretion of original issuance discount, and interest expense of $2,081.

~~We expect to purchase approximately $30,000 of equipment in connection with the expansion of our business during the next twelve months.~~41

~~Fiscal~~Net loss ~~year~~before ~~end~~income taxes

~~Our~~Net loss ~~fiscal~~before ~~year~~income ~~end~~taxes isfor ~~December~~the 31six months ended June 30, 2024 totaled $2,119,751 primarily due to decreases in professional fees, depreciation, insurance costs, rent, research and development costs, investor relations costs, and general and administration costs, offset primarily by stock based compensation, consulting fees, travel costs, compensation costs, and marketing costs, compared to a loss of $1,620,471 for the six months ended June 30, 2023 primarily due to decreases in consulting fees, depreciation, amortization, and general and administration costs, offset primarily by compensation costs, marketing costs, investor relations costs, research and development costs, rent, and insurance.

42Liquidity and Capital Resources

~~Critical Accounting Policies~~Going Concern

The accompanying ~~SEC~~financial ~~has~~statements ~~defined~~have been prepared assuming the Company will continue as a ~~company’s~~going ~~critical~~concern, ~~accounting~~which contemplates, among ~~policies~~other asthings, the ~~ones~~realization ~~that~~of ~~are~~assets ~~most~~and ~~important~~satisfaction toof liabilities in the ~~portrayal~~normal course of ~~the~~business. The Company’s ~~financial~~had ~~condition~~an ~~and~~accumulated deficit ~~results~~of $16,801,475 at June 30, 2025, had a working capital deficit of ~~operations~~$5,487,629 at June 30, 2025, had net losses of $1,451,187 and ~~which~~$2,119,751, ~~require~~and $862,383 and $1,620,471 for the ~~Company~~three toand ~~make~~six ~~its~~months ~~most~~ended ~~difficult~~June 30, 2025 and ~~subjective~~2024, ~~judgments~~respectively, ~~often~~and asnet acash ~~result~~used in operating activities of $446,882 and $418,406 for the ~~need~~six tomonths ~~make~~ended ~~estimates~~June of30, ~~matters that~~2025 ~~are~~and ~~inherently~~2024, ~~uncertain.~~respectively, ~~Based~~with onno ~~this~~revenue ~~definition~~earned since inception, weand ~~have~~a ~~identified~~lack of operational history. These matters raise substantial doubt about the ~~critical~~Company’s ~~accounting~~ability ~~policies~~to ~~and~~continue ~~judgments~~as a ~~addressed~~going ~~below~~concern.

~~The~~While the ~~following~~Company ~~are~~is ~~deemed~~attempting to expand operations and increase revenues, the Company’s cash position may not be significant enough to support the ~~most~~Company’s ~~critical~~daily ~~accounting~~operations. Management intends to raise additional funds by way of a public offering or an asset ~~policies~~sale ~~affecting~~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.

~~Use~~The condensed ofconsolidated ~~Estimates~~financial statements do not include any adjustments that might be necessary if we are unable to continue as a going concern.

~~The~~General – ~~preparation~~Overall, ofwe ~~these~~had ~~financial~~a ~~statements~~decrease in ~~accordance with~~cash ~~accounting~~flows ~~principles~~for ~~generally accepted in~~ the ~~United~~six ~~States~~months ofended ~~America~~June ~~requires~~30, ~~management~~2025 ~~to make estimates and assumptions that affect the reported amounts~~ of ~~assets~~$11,685 ~~and~~resulting 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~~cash ~~estimates and~~used ~~such differences may be material to the financial statements. The more significant estimates and assumptions by management include~~in ~~among~~operating ~~others:~~activities ~~allocation~~ of payroll expense to research and development and 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$446, ~~including stock price volatility~~882, ~~the~~offset ~~expected~~partially ~~life~~by ofcash ~~stock~~provided ~~options,~~by ~~risk~~financing ~~free~~activities ~~interest rate and the fair value~~ of ~~the underlying common stock on the date of grant~~$435,197. ~~The current economic environment has increased the degree of uncertainty inherent in these estimates and assumptions.~~

~~Recent~~The following ~~Accounting~~is ~~Pronouncements~~a summary of our cash flows provided by (used in) operating, investing, and financing activities during the periods indicated:

There are no recently issued accounting updates that are expected to have a material impact on the Company’s consolidated financial statements except for:

	Six Months Ended June 30,
	2025			2024

Net cash provided by (used in):
Operating activities	$	(446,882	)	$	(418,406	)
Investing activities		-			-
Financing activities		435,197			460,360
	$	(11,685	)	$	41,954

~~Future~~Cash Flows ~~Contractual~~from ~~Obligations~~Operating Activities – For the six months ended June 30, 2025, net cash used in operations was $446,882 compared to net cash used in operations of $418,406 for the six months ended June 30, 2024. Net cash used in operations was primarily due to a net loss of $2,119,751 for six months ended June 30, 2025 and ~~Commitments~~the changes in operating assets and liabilities of $468,649, primarily due to the changes in other current assets of $7,697, other assets of $20,711, accounts payable of $121,462, accrued payroll and payroll taxes of $317,113, and other current liabilities of $1,666. In addition, net cash used in operating activities includes adjustments to reconcile net profit from depreciation expense of $1,363, stock based compensation of $100,000, accretion of original issuance costs of $175,370, the accretion of debt discount of $69,879, modification of warrants of $17,505, and the inducement of preferred shares of $845,901, offset partially by the settlement of lease of $5,798.

~~Refer~~For the tosix ~~Note~~months 3ended inJune ~~the~~30, ~~accompanying~~2024, ~~notes~~net tocash ~~the~~used ~~consolidated financial~~in ~~statements~~operations ~~for~~was ~~future~~primarily ~~contractual~~due ~~obligations~~to a net loss of $1,620,471 and ~~commitments.~~the ~~Future~~changes ~~contractual~~in ~~obligations~~operating assets and ~~commitments~~liabilities ~~are~~of ~~based~~$738,564, onprimarily due to the ~~terms~~ changes in accounts payable of ~~the~~$26,718, ~~relevant~~other ~~agreements~~current assets of $13,641, accrued payroll and ~~appropriate~~payroll ~~classification~~taxes of ~~items~~$701,399, ~~under~~offset ~~GAAP~~partially asby ~~currently~~the change in ~~effect~~other current liabilities of $3,194. ~~Future~~In ~~events~~addition, ~~could~~net ~~cause~~cash used ~~actual~~in ~~payments~~operating activities includes adjustments to ~~differ~~reconcile net profit from ~~these~~depreciation ~~amounts~~expense of $2,885, stock based compensation of $75,000, accretion of original issuance costs of $225,672, and the accretion of debt discount of $159,943.

WeCash Flows ~~incur~~from ~~contractual~~Investing ~~obligations~~Activities ~~and~~– ~~financial~~For ~~commitments in~~ the ~~normal~~six ~~course~~months ofended ~~our~~June ~~operations and financing activities. Contractual obligations include future cash payments required under existing contracts~~30, ~~such~~2025 ~~as debt~~ and ~~lease~~2024, ~~agreements.~~the ~~These~~Company ~~obligations~~had ~~may~~no ~~result~~cash ~~from~~flows ~~both general financing activities and~~ from ~~commercial~~investing ~~arrangements that are directly supported by related operating~~ activities. ~~Details on these obligations are set forth below.~~

~~On May 27, 2021, the Company entered~~Cash ~~into~~Flows afrom ~~sixty-three~~Financing ~~month~~Activities ~~lease~~– ~~for~~For ~~its~~the ~~corporate~~six ~~office~~months atended ~~$5,955 per month commencing~~ June 1530, ~~2021~~2025, ~~maturing~~net ~~September~~cash ~~30,~~provided ~~2026.~~by ~~On May~~financing ~~15,~~was ~~2025~~$435,197, due ~~the~~to ~~Company~~proceeds ~~entered~~from ~~into~~short aterm ~~lease~~convertible ~~termination~~notes ~~agreement~~of ~~(“Termination~~$425,197 ~~Agreement”)~~and ~~with~~proceeds ~~HGIT~~from ~~Historic~~short-term ~~Decatur LP~~promissory tonotes ~~terminate~~of ~~the Company’s San Diego~~$10,000, ~~California~~compared ~~office~~to ~~space.~~cash provided ~~The~~by ~~Termination~~financing ~~Agreement~~activities ~~allows~~of ~~HGIT~~$460,360, ~~Historic~~due ~~Decatur~~to LPproceeds ~~to retain~~from ~~the~~short ~~security~~term ~~deposit~~convertible notes of $20470,~~711~~360 and toadvance befrom ~~paid~~shareholder of $1235,000, ~~within~~and ~~twelve~~repayments ~~(12)~~of ~~months~~advance from ~~the~~shareholder ~~termination~~of ~~date~~$45,000. ~~The Company was released from any other obligations.~~

43Financing – We expect that our current working capital position, together with our expected future cash flows from operations will be insufficient to fund our operations in the ordinary course of business, anticipated capital expenditures, debt payment requirements and other contractual obligations for at least the next twelve months. As stated above, Management intends to raise additional funds by way of a public offering or an asset sale transaction, however there can be no assurance that we will be successful in completing such transactions.

~~Off-Balance~~We have ~~Sheet~~no ~~Arrangements~~present agreements or commitments with respect to any material acquisitions of other businesses, products, product rights or technologies or any other material capital expenditures. However, we will continue to evaluate acquisitions of and/or investments in products, technologies, capital equipment or improvements or companies that complement our business and may make such acquisitions and/or investments in the future. Accordingly, we may need to obtain additional sources of capital in the future to finance any such acquisitions and/or investments. We may not be able to obtain such financing on commercially reasonable terms, if at all. Due to the ongoing global economic crisis, we believe it may be difficult to obtain additional financing if needed. Even if we are able to obtain additional financing, it may contain undue restrictions on our operations, in the case of debt financing, or cause substantial dilution for our stockholders, in the case of equity financing.

~~As of March 31, 2025, we have not entered into any~~Regulation ~~transaction,~~D ~~agreement or other contractual arrangement with an entity unconsolidated under which it has:~~

●On January a9, ~~retained~~2025, orthe ~~contingent~~Company ~~interest~~initiated ina ~~assets~~Regulation ~~transferred~~D offering to ~~the~~sell ~~unconsolidated~~up ~~entity~~to or750,000 ~~similar~~Units ~~arrangement~~at ~~that~~a ~~serves~~price asof ~~credit;~~$5,000 ●per ~~liquidity~~unit orwith ~~market~~each ~~risk~~Unit consisting ~~support~~of toone ~~such~~(1) ~~entity~~$5,500 ~~for~~principal ~~such~~amount ~~assets;~~convertible ●debenture an(convertible ~~obligation,~~at ~~including~~two dollars ($2.00) per share into the Company’s common stock) and a ~~contingent~~Warrant ~~obligation~~to purchase 1,250 ~~under~~shares aof ~~contract~~common ~~that~~stock ~~would~~at be$4.00 ~~accounted~~per ~~for~~share. asThe Debentures have a ~~derivative~~principal ~~instrument;~~amount orequal to ●110% anof ~~obligation~~such Purchaser’s subscription amount, ~~including~~convertible aat ~~contingent~~$2.00 ~~obligation,~~per ~~arising~~share ~~out~~and ofmaturing aone ~~variable~~(1) ~~interest~~year infrom anthe ~~unconsolidated~~date ~~entity~~the ~~that~~subscription amount is ~~held~~accepted by the Company. The Warrants for a number of shares equal to the subscription amount divided by the conversion price with an exercise price of $4.00 per share, exercisable upon issuance and ~~material~~will toexpire usfive years from issuance. The Debentures will not be redeemable but contain an automatic conversion feature, ~~where~~which will cause all principal and interest due under the Debenture to automatically convert if our common stock is listed for trading on a national securities exchange, such ~~entity~~as ~~provides~~NASDAQ ~~financing~~or the NYSE. As of June 30, ~~liquidity~~2025, a ~~market~~total ~~risk~~of or69 ~~credit~~Units ~~risk~~were ~~support~~sold to oraccredited ~~engages~~investors inat ~~leasing,~~a ~~hedging~~price of $5,500 orper ~~research~~Unit ~~and~~totaling ~~development~~$379,717 ~~services~~(total ~~with~~of us$345,197 cash was received).

~~Inflation~~43

~~We do not believe that inflation has had a material~~Convertible ~~effect~~Notes ~~on our results of operations.~~Payable

~~ITEM~~In 3fiscal year 2024 and through August 31, 2025, the Company entered into Original Issue Discount Senior Convertible Debentures (the “2024 Notes”) totaling (i) $1,002,229 aggregate principal amount of Notes (total of $907,890 cash was received) due between January and November 2025 based on $1.00 ~~QUANTITATIVE~~for ~~AND~~each ~~QUALITATIVE~~$0.90909 ~~DISCLOSURE~~paid ~~ABOUT~~by ~~MARKET~~the ~~RISK~~noteholders and (ii) five-year Common Stock Purchase Warrants (“Warrants”) to purchase up to an aggregate of 228,208 shares of the Company’s Common Stock at an exercise price of $4.00 per share. The aggregate cash subscription amount received by the Company for the issuance of the Note and Warrants was $907,890 which was issued at a $94,339 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 $2.00 per share, subject to adjustment as provided therein, such as stock splits and stock dividends.

WeIn September ~~are~~2024, aholders ~~smaller~~converted ~~reporting~~$474,793 ~~company~~in asexchange ~~defined~~for bythe ~~Rule 12b-2~~issuance of ~~the~~118,700 ~~Securities~~shares ~~Exchange Act~~ of ~~1934~~Common ~~and~~Stock ~~are not required~~ to ~~provide~~ the ~~information under this item~~holders.

~~ITEM~~In May 4.and ~~CONTROLS~~June ~~AND~~2024, ~~PROCEDURES~~holders converted $232,937 in exchange for the issuance of 38,826 shares of Common Stock to the holders.

~~Evaluation~~On April 10, 2024, Osher elected to exchange $621,000 of ~~Disclosure~~Notes ~~Controls~~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 ~~Procedures~~recapitalizations, and for issuances of additional shares at an issue price of less than the conversion ratio.

~~We maintain disclosure controls and procedures (as~~On ~~defined~~April in9, ~~Rule~~2024, ~~13a-l5(e)~~Brio ~~under~~elected ~~the~~to ~~Exchange~~exchange ~~Act)~~$220,420 ~~that~~of ~~are~~Notes ~~designed~~for toan ~~ensure~~aggregate ~~that~~of ~~information~~292.4 ~~that~~shares ~~would~~of beSeries ~~required~~B toConvertible bePreferred ~~disclosed~~Stock. Each inSeries ~~Exchange~~B ~~Act~~Convertible ~~reports~~Preferred isShare ~~recorded,~~converts ~~processed,~~into ~~summarized~~125.63 ~~and~~shares ~~reported~~of ~~within~~ the ~~time period specified in the SEC~~Company’s ~~rules~~common ~~and forms~~stock, ~~and~~subject ~~that~~to ~~such~~antidilution ~~information~~adjustments for isany ~~accumulated~~stock splits and ~~communicated to our management~~recapitalizations, ~~including~~and tofor ~~our~~issuances ~~Chief~~of ~~Executive~~additional ~~Officer~~shares ~~and~~at ~~Chief Financial~~an ~~Officer,~~issue asprice ~~appropriate,~~of toless ~~allow~~than ~~timely~~the ~~decisions~~conversion ~~regarding required disclosure~~ratio.

~~Our management, under the supervision and with the~~Capital participation of our CEO and Chief Financial Officer (“CFO”), has evaluated the effectiveness of our disclosure controls and procedures as defined in SEC Rules 13a-15(e) and 15d-15(e) as of the end of the period covered by this report. Based on such evaluation, management identified deficiencies that were determined to be a material weakness.Expenditures

~~Management’s~~We expect ~~Report~~to onpurchase ~~Internal~~approximately ~~Controls over~~$30,000 ~~Financial~~of ~~Reporting~~equipment in connection with the expansion of our business during the next twelve months.

~~The Company’s management is responsible for~~Lease establishing and maintaining effective internal control over financial reporting (as defined in Rule 13a-l5(f) of the Securities Exchange Act). Management assessed the effectiveness of the Company’s internal control over financial reporting as of March 31, 2025. In making this assessment, management used the criteria set forth by the Committee of Sponsoring Organizations of the Treadway Commission (“COSO”) (2013). Based on that assessment, management believes that, as of March 31, 2025, the Company’s internal control over financial reporting was ineffective based on the COSO criteria, due to the following material weaknesses listed below.Termination

~~The~~On May ~~specific~~15, ~~material~~2025, ~~weaknesses~~the ~~identified~~Company byentered ~~the~~into a lease termination agreement (“Termination Agreement”) with HGIT Historic Decatur ~~company~~LP to terminate the Company’s ~~management~~San asDiego, ofCalifornia ~~end~~office ofspace. The Termination Agreement allows HGIT Historic Decatur LP to retain the ~~period~~security ~~covered~~deposit byof ~~this~~$20,711 ~~report~~(recorded ~~include~~as operating lease expense) and to be paid $12,000 within twelve (12) months from the termination ~~following:~~date. The Company was released from any other obligations.

●Fiscal year we have not performed a risk assessment and mapped our processes to control objectives; ● we have not implemented comprehensive entity-level internal controls; ● we have not implemented adequate system and manual controls; and ● we do not have sufficient segregation of duties. As such, the officers approve their own related business expense reimbursementsend

44Our fiscal year end is December 31.

~~Despite the material weaknesses reported above, our~~Critical ~~management~~Accounting believes that our condensed consolidated financial statements included in this report fairly present in all material respects our financial condition, results of operations and cash flows for the periods presented and that this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report.Policies

~~This~~The SEC ~~report~~has ~~does~~defined ~~not~~a ~~include~~company’s ancritical ~~attestation~~accounting ~~report of~~policies ~~our~~as ~~registered~~the ~~public~~ones ~~accounting~~that ~~firm~~are ~~regarding~~most ~~internal~~important ~~control~~to ~~over~~the ~~financial~~portrayal ~~reporting.~~of ~~Management~~the Company’s financial ~~report~~condition ~~was~~and ~~not~~results ~~subject~~ of operations and which require the Company to ~~attestation~~make byits ~~our~~most ~~registered~~difficult ~~public~~and ~~accounting~~subjective ~~firm~~judgments, ~~pursuant~~often as toa ~~rules~~result of the ~~Commission~~need to make estimates of matters that ~~permit~~are usinherently touncertain. ~~provide~~Based ~~only~~on ~~management’s~~this definition, we have identified the ~~report~~critical inaccounting ~~this~~policies ~~report~~and judgments addressed below.

~~Management’s~~The following ~~Remediation~~are ~~Plan~~deemed to be the most critical accounting policies affecting the Company.

The weaknesses and their related risks are not uncommon in a company of our size because of the limitations in the size and number of staff. Due to our size and nature, segregation of all conflicting duties has not always been possible and may not be economically feasible.44

~~However, we~~Use ~~plan to take steps to enhance and improve the design~~ of our internal control over financial reporting. During the period covered by this annual report on Form 10-K, we have not been able to remediate the material weaknesses identified above. To remediate such weaknesses, we plan to implement the following changes in the current fiscal year as resources allow:Estimates

~~(i)~~The preparation ~~Appoint~~of ~~additional~~these ~~qualified~~financial ~~personnel~~statements in accordance with accounting principles generally accepted in the United States of America requires management to ~~address~~make ~~inadequate~~estimates ~~segregation~~and assumptions that affect the reported amounts of ~~duties~~assets and ~~implement~~liabilities ~~modifications~~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 ~~our~~the financial ~~controls~~statements. The more significant estimates and assumptions by management include among others: allocation of payroll expense to ~~address~~research ~~such~~and ~~inadequacies;~~development and 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.

~~The remediation efforts set out herein will be implemented~~Recent inAccounting the 2024 fiscal year. Because of the inherent limitations in all control systems, no evaluation of controls can provide absolute assurance that all control issues, if any, within our company have been detected. These inherent limitations include the realities that judgments in decision-making can be faulty and that breakdowns can occur because of simple error or mistake.Pronouncements

~~Management~~There are ~~believes~~no ~~that~~recently ~~despite~~issued ~~our~~accounting ~~material~~updates ~~weaknesses set~~that ~~forth~~are ~~above,~~expected ~~our~~to ~~condensed~~have ~~consolidated~~a ~~financial~~material ~~statements~~impact ~~for~~on the ~~three~~Company’s ~~months~~consolidated ~~ended~~financial ~~March 31, 2025 are fairly stated, in all material~~statements ~~respects,~~except ~~in accordance with U.S. GAAP.~~for:

~~Changes~~In November 2024, the FASB issued ASU 2024-03, “Income Statement—Reporting Comprehensive Income—Expense Disaggregation Disclosures (Subtopic 220-40): Disaggregation of Income Statement Expenses,” which is intended to improve disclosures about a public business entity’s expenses and address requests from investors for more detailed information about the types of expenses in ~~Internal~~commonly presented ~~Control~~expense captions. Such information should allow investors to better understand an entity’s performance, assess future cash flows, and compare performance over ~~Financial~~time ~~Reporting~~and with other entities. The amendments will require public business entities to disclose in the notes to the financial statements, at each interim and annual reporting period, specific information about certain costs and expenses, including purchases of inventory, employee compensation, depreciation, and intangible asset amortization included in each expense caption presented on the face of the income statement, and the total amount of an entity’s selling expenses. The amendments are effective for annual reporting periods beginning after December 15, 2026, and interim reporting periods beginning after December 15, 2027, and may be applied either prospectively or retrospectively. Early adoption is permitted. The Company is currently evaluating the impact of adopting this guidance on the consolidated financial statements.

~~There have been no changes in our internal control~~Future ~~over~~Contractual ~~financial~~Obligations ~~reporting~~and ~~during the three months ending March 31, 2025 that have materially affected, or are reasonably likely to materially affect, our internal control over financial reporting.~~Commitments

~~PART~~Refer to IINote –3 ~~OTHER~~in ~~INFORMATION~~the accompanying notes to the consolidated financial statements for future contractual obligations and commitments. Future contractual obligations and commitments are based on the terms of the relevant agreements and appropriate classification of items under GAAP as currently in effect. Future events could cause actual payments to differ from these amounts.

~~ITEM~~We incur 1contractual obligations and financial commitments in the normal course of our operations and financing activities. ~~LEGAL~~Contractual obligations ~~PROCEDINGS~~include future cash payments required under existing contracts, such as debt and lease agreements. These obligations may result from both general financing activities and from commercial arrangements that are directly supported by related operating activities. Details on these obligations are set forth below.

~~From time to time, we may become party to litigation~~Off-Balance orSheet other legal proceedings that we consider to be a part of the ordinary course of our business. We are not currently involved in legal proceedings that could reasonably be expected to have a material adverse effect on our business, prospects, financial condition or results of operations. We may become involved in material legal proceedings in the future. To the best our knowledge, none of our directors, officers or affiliates is involved in a legal proceeding adverse to our business or has a material interest adverse to our business.Arrangements

45As of June 30, 2025, we have not entered into any transaction, agreement or other contractual arrangement with an entity unconsolidated under which it has:

~~ITEM~~● ~~1A.~~a ~~RISK~~retained ~~FACTORS~~or contingent interest in assets transferred to the unconsolidated entity or similar arrangement that serves as credit; ● liquidity or market risk support to such entity for such assets; ● an obligation, including a contingent obligation, under a contract that would be accounted for as a derivative instrument; or ● an obligation, including a contingent obligation, arising out of a variable interest in an unconsolidated entity that is held by, and material to us, where such entity provides financing, liquidity, market risk or credit risk support to or engages in leasing, hedging, or research and development services with us.

~~We are a Smaller Reporting Company as defined by Rule 12b-2 of the Securities Exchange Act of 1934 and are not required to provide the information under this item.~~45

~~ITEM 2. UNREGISTERED SALES OF EQUITY SECURITIES AND USE OF PROCEEDS.~~Inflation

~~Regulation~~We do Dnot believe that inflation has had a material effect on our results of operations.

~~On January 9, 2025, the Company initiated a Regulation~~ITEM ~~D offering to sell up to 750,000 Units at a price of $5,000 per unit with each Unit consisting of one (1) $5,500 principal amount convertible debenture (convertible at Four dollars ($4~~3.~~00)~~ ~~per~~QUANTITATIVE ~~share~~AND ~~into~~QUALITATIVE ~~the~~DISCLOSURE ~~Company’s~~ABOUT ~~common~~MARKET stock) and a Warrant to purchase 1,250 shares of common stock at $6.00 per share. The Debentures have a principal amount equal to 110% of such Purchaser’s subscription amount, convertible at $4.00 per share and maturing one (1) year from the date the subscription amount is accepted by the Company. The Warrants for a number of shares equal to the subscription amount divided by the conversion price with an exercise price of $6.00 per share, exercisable upon issuance and will expire five years from issuance. The Debentures will not be redeemable but contain an automatic conversion feature, which will cause all principal and interest due under the Debenture to automatically convert if our common stock is listed for trading on a national securities exchange, such as NASDAQ or the NYSE. As of March 31, 2025, a total of 69 Units were sold to accredited investors at a price of $5,500 per Unit totaling $379,717 (total of $295,197 cash was received and $50,000 as a subscription receivable).RISK

~~ITEM~~We are 3.a ~~DEFAULTS~~smaller ~~UPON~~reporting ~~SENIOR~~company ~~SECURITIES~~as defined by Rule 12b-2 of the Securities Exchange Act of 1934 and are not required to provide the information under this item.

~~The Company~~ITEM ~~has not repaid three Osher convertible notes totaling $316,350 that matured on March 31, 2025 and the convertible notes are now in default~~4. ~~The~~ ~~Company~~CONTROLS isAND ~~currently in discussions to restructure the terms of these notes.~~PROCEDURES

~~The Company~~Evaluation ~~has~~of ~~not~~Disclosure ~~repaid~~Controls ~~two Brio convertible notes totaling $125,000 that matured on March 31, 2025~~ and ~~the convertible notes are now in default. The Company is currently in discussions to restructure the terms of these notes.~~Procedures

~~The Company~~We ~~has~~maintain ~~not~~disclosure ~~repaid~~controls and procedures (as defined in Rule 13a-l5(e) under the ~~Brio~~Exchange ~~January~~Act) 8,that ~~2024~~are ~~convertible~~designed ~~note~~to ofensure ~~$44,000~~that information that ~~matured~~would onbe ~~January~~required 8to be disclosed in Exchange Act reports is recorded, ~~2025~~processed, summarized and reported within the ~~convertible~~time ~~note~~period specified in the SEC’s rules and forms, and that such information is ~~now~~accumulated inand communicated to our management, including ~~default.~~to ~~The~~our ~~Company~~Chief isExecutive ~~currently~~Officer inand ~~discussions~~Chief Financial Officer, as appropriate, to ~~restructure~~allow ~~the~~timely ~~terms~~decisions ofregarding ~~the~~required ~~note~~disclosure.

~~ITEM~~Our management, 4under the supervision and with the participation of our CEO and Chief Financial Officer (“CFO”), has evaluated the effectiveness of our disclosure controls and procedures as defined in SEC Rules 13a-15(e) and 15d-15(e) as of the end of the period covered by this report. ~~MINE~~Based ~~SAFTEY~~on ~~DISCLOSURE~~such evaluation, management identified deficiencies that were determined to be a material weakness.

~~Pursuant to Section 1503(a) of the Dodd-Frank Wall~~Management’s ~~Street~~Report ~~Reform~~on ~~and~~Internal ~~Consumer~~Controls ~~Protection~~over ~~Act,~~Financial issuers that are operators, or that have a subsidiary that is an operator, of a coal or other mine in the United States are required to disclose in their periodic reports filed with the SEC information regarding specified health and safety violations, orders and citations, related assessments and legal actions, and mining-related fatalities from the Federal Mine Safety and Health Administration, or MSHA, under the Federal Mine Safety and Health Act of 1977, or the Mine Act. During the quarter ended March 31, 2025, we did not have any projects that were in production and as such, were not subject to regulation by MSHA under the Mine Act.Reporting

~~ITEM~~The Company’s 5management is responsible for establishing and maintaining effective internal control over financial reporting (as defined in Rule 13a-l5(f) of the Securities Exchange Act). ~~OTHER~~Management ~~INFORMITON~~assessed the effectiveness of the Company’s internal control over financial reporting as of June 30, 2025. In making this assessment, management used the criteria set forth by the Committee of Sponsoring Organizations of the Treadway Commission (“COSO”) (2013). Based on that assessment, management believes that, as of June 30, 2025, the Company’s internal control over financial reporting was ineffective based on the COSO criteria, due to the following material weaknesses listed below.

~~During the quarter~~The ~~ended~~specific ~~March~~material ~~31,~~weaknesses ~~2025,~~identified noby ~~director or officer of~~ the ~~Company~~company’s ~~adopted~~management ~~or terminated a “Rule 10b5-1 trading arrangement” or “non-Rule 10b5-1 trading arrangement,”~~ as ~~each~~of ~~term~~end isof ~~defined~~the inperiod ~~Item~~covered ~~408(a)~~by ofthis ~~Regulation~~report ~~S-K.~~include the following:

46● we have not performed a risk assessment and mapped our processes to control objectives; ● we have not implemented comprehensive entity-level internal controls; ● we have not implemented adequate system and manual controls; and ● we do not have sufficient segregation of duties. As such, the officers approve their own related business expense reimbursements

~~Item~~Despite the 6.material ~~Exhibits~~weaknesses reported above, our management believes that our condensed consolidated financial statements included in this report fairly present in all material respects our financial condition, results of operations and cash flows for the periods presented and that this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report.

Exhibit
Number		Description
1.1		Form of Underwriting Agreement**
3.1*		Amended and Restated Certificate of Incorporation, as filed with the Secretary of State of the State of Delaware
3.2*		Bylaws of the Registrant, as currently in effect (Filed as Exhibit 3.2 to the Registration Statement on Form S-1 filed by the Registrant on May 27, 2015, and incorporated herein by reference).
10.1*		Share Exchange Agreement dated August 25, 2020 (Filed as Exhibit 10.1 to the Current Report on Form 8-K filed by the Registrant on August 31, 2020 and incorporated herein by reference)
10.2*		Operating Lease (Filed as Exhibit 10.2 to the Registration Statement on Form S-1 filed by the Registrant on April 10, 2024, and incorporated herein by reference).
10.3*		Employment Agreement for Jeremy Ferrell (Filed as Exhibit 99.1 to the Current Report on Form 8-K filed by the Registrant on March 9, 2022 and incorporated herein by reference)
10.4*		January 2020 Financing Documents and Extensions (Filed as Exhibit 10.4 to the Registration Statement on Form S-1 filed by the Registrant on April 10, 2024, and incorporated herein by reference).
10.5*		June 23, 2020 Financing Documents (Filed as Exhibit 10.5 to the Registration Statement on Form S-1 filed by the Registrant on April 10, 2024, and incorporated herein by reference).
10.6*		September 17, 2020 Financing Documents (Filed as Exhibit 10.6 to the Registration Statement on Form S-1 filed by the Registrant on April 10, 2024, and incorporated herein by reference).
10.7*		Senior Convertible Debenture dated May 10, 2022 (Filed as Exhibit 10.7 to the Registration Statement on Form S-1 filed by the Registrant on April 10, 2024, and incorporated herein by reference).
10.8*		Warrant dated May 10, 2022 (Filed as Exhibit 10.8 to the Registration Statement on Form S-1 filed by the Registrant on April 10, 2024, and incorporated herein by reference).
10.9*		Warrant dated October 18, 2021 (Filed as Exhibit 10.9 to the Registration Statement on Form S-1 filed by the Registrant on April 10, 2024, and incorporated herein by reference).
10.10*		Senior Convertible Debenture dated March 23, 2022 (Filed as Exhibit 10.10 to the Registration Statement on Form S-1 filed by the Registrant on April 10, 2024, and incorporated herein by reference).
10.11*		Warrant dated March 23, 2022 (Filed as Exhibit 10.11 to the Registration Statement on Form S-1 filed by the Registrant on April 10, 2024, and incorporated herein by reference).
10.12*		Senior Convertible Debenture dated March 23, 2022 (Filed as Exhibit 10.12 to the Registration Statement on Form S-1 filed by the Registrant on April 10, 2024, and incorporated herein by reference).
10.13*		Warrant dated March 23, 2022 (Filed as Exhibit 10.13 to the Registration Statement on Form S-1 filed by the Registrant on April 10, 2024, and incorporated herein by reference).
10.14*		Senior Convertible Debenture dated April 28, 2022 (Filed as Exhibit 10.14 to the Registration Statement on Form S-1 filed by the Registrant on April 10, 2024, and incorporated herein by reference).
10.15*		Warrant dated April 28, 2022 (Filed as Exhibit 10.15 to the Registration Statement on Form S-1 filed by the Registrant on April 10, 2024, and incorporated herein by reference).
10.16*		June 1, 2022 Financing Documents (Filed as Exhibit 10.16 to the Registration Statement on Form S-1 filed by the Registrant on April 10, 2024, and incorporated herein by reference).
10.17*		June 22, 2022 Financing Documents (Filed as Exhibit 10.17 to the Registration Statement on Form S-1 filed by the Registrant on April 10, 2024, and incorporated herein by reference).
10.18*		Set of Form Documents for July 2022 Financing (Filed as Exhibit 10.18 to the Registration Statement on Form S-1 filed by the Registrant on April 10, 2024, and incorporated herein by reference).
10.19*		August 31, 2022 Financing Documents (Filed as Exhibit 10.19 to the Registration Statement on Form S-1 filed by the Registrant on April 10, 2024, and incorporated herein by reference).
10.20*		September 9, 2022 Financing Documents (Filed as Exhibit 10.20 to the Registration Statement on Form S-1 filed by the Registrant on April 10, 2024, and incorporated herein by reference).
10.21*		October 20, 2022 Financing Documents (Filed as Exhibit 10.21 to the Registration Statement on Form S-1 filed by the Registrant on April 10, 2024, and incorporated herein by reference).
10.22*		November 9, 2022 Financing Documents (Filed as Exhibit 10.22 to the Registration Statement on Form S-1 filed by the Registrant on April 10, 2024, and incorporated herein by reference).
10.23*		November 14, 2022 Financing Documents (Filed as Exhibit 10.23 to the Registration Statement on Form S-1 filed by the Registrant on April 10, 2024, and incorporated herein by reference).
10.24*		November 21, 2022 Financing Documents (Filed as Exhibit 10.24 to the Registration Statement on Form S-1 filed by the Registrant on April 10, 2024, and incorporated herein by reference).
10.25*		December 22, 2022 Financing Documents (Filed as Exhibit 10.25 to the Registration Statement on Form S-1 filed by the Registrant on April 10, 2024, and incorporated herein by reference).
10.26*		September 14, 2023 Financing Documents (Filed as Exhibit 10.26 to the Registration Statement on Form S-1 filed by the Registrant on April 10, 2024, and incorporated herein by reference).
21.1*		Subsidiaries of the Registrant (Filed as Exhibit 21.1 to the Registration Statement on Form S-1 filed by the Registrant on April 10, 2024, and incorporated herein by reference).
31.1		Certification by Principal Executive Officer pursuant to Rule 13a-14(a)
32.1		Certification by Principal Executive Officer pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002.
101.INS		Inline XBRL Instance Document
101.SCH		Inline XBRL Taxonomy Extension Schema Document
101.CAL		Inline XBRL Taxonomy Extension Calculation Linkbase Document
101.DEF		Inline XBRL Taxonomy Extension Definition Linkbase Document
101.LAB		Inline XBRL Taxonomy Extension Label Linkbase Document
101.PRE		Inline XBRL Taxonomy Extension Presentation Linkbase Document
104		Cover Page Interactive Data File (embedded within the Inline XBRL document)
*		Previously filed.
**		To be filed by amendment
***		Filed herewith

This report does not include an attestation report of our registered public accounting firm regarding internal control over financial reporting. Management’s report was not subject to attestation by our registered public accounting firm pursuant to rules of the Commission that permit us to provide only management’s report in this report.

~~All references to Registrant’s Forms 8-K, 10-K and 10-Q include reference to File No. 000-55575~~46

47Management’s Remediation Plan

~~SIGNATURES~~The weaknesses and their related risks are not uncommon in a company of our size because of the limitations in the size and number of staff. Due to our size and nature, segregation of all conflicting duties has not always been possible and may not be economically feasible.

~~Pursuant~~However, we plan to ~~the~~take ~~requirements~~steps ofto ~~the~~enhance ~~Securities~~and ~~Exchange Act~~improve the design of ~~1934,~~our ~~the~~internal ~~registrant~~control ~~has~~over ~~duly~~financial ~~caused~~reporting. During the period covered by this annual report toon beForm ~~signed~~10-K, onwe ~~its~~have ~~behalf~~not bybeen able to remediate the ~~undersigned~~material ~~hereunto~~weaknesses ~~duly~~identified ~~authorized~~above. To remediate such weaknesses, we plan to implement the following changes in the current fiscal year as resources allow:

	Sigyn Therapeutics, Inc. a Delaware corporation
Dated: May 20, 2025	By:	/s/ James Joyce
		James Joyce
		Chief Executive Officer and Director (Principal Executive Officer and Principal Financial and Accounting Officer)
Dated: May 20, 2025	By:	/s/ Craig Roberts
		Craig Roberts
		Chief Technology Officer and Director

(i)

Appoint additional qualified personnel to address inadequate segregation of duties and implement modifications to our financial controls to address such inadequacies;

~~Pursuant~~The remediation toefforts set out herein will be implemented in the ~~requirements~~2025 fiscal year. Because of the ~~Securities~~inherent ~~Exchange~~limitations in all control systems, ~~Act~~no evaluation of ~~1934~~controls can provide absolute assurance that all control issues, ~~this~~if ~~report~~any, ~~has~~within our company have been ~~signed~~detected. ~~below~~These inherent bylimitations include the ~~following~~realities ~~persons~~that onjudgments ~~behalf~~in ofdecision-making ~~the~~can ~~registrant~~be faulty and inthat ~~the~~breakdowns ~~capacities~~can ~~and~~occur onbecause ~~the~~of ~~dates~~simple ~~indicated~~error or mistake.

Signature	Title	Date
/s/ James Joyce	Chief Executive Officer and Director	May 20, 2024
James Joyce	(Principal Executive Officer and Principal Financial and Accounting Officer)
/s/ Craig Roberts	CTO and Director	May 20, 2024
Craig Roberts

Management believes that despite our material weaknesses set forth above, our condensed consolidated financial statements for the three and six months ended June 30, 2025 are fairly stated, in all material respects, in accordance with U.S. GAAP.

/s/ Richa Nand	Director	May 20, 2024
Richa Nand
/s/ Jim Dorst	Director	May 20, 2024
Jim Dorst
/s/ Chris Wetzel	Director	May 20, 2024
Chris Wetzel
/s/ Michael Ryan	Director	May 20, 2024
Michael Ryan

Changes in Internal Control over Financial Reporting

48There have been no changes in our internal control over financial reporting during the three months ending June 30, 2025 that have materially affected, or are reasonably likely to materially affect, our internal control over financial reporting.

PART II – OTHER INFORMATION

ITEM 1. LEGAL PROCEDINGS.

From time to time, we may become party to litigation or other legal proceedings that we consider to be a part of the ordinary course of our business. We are not currently involved in legal proceedings that could reasonably be expected to have a material adverse effect on our business, prospects, financial condition or results of operations. We may become involved in material legal proceedings in the future. To the best our knowledge, none of our directors, officers or affiliates is involved in a legal proceeding adverse to our business or has a material interest adverse to our business.

ITEM 1A. RISK FACTORS.

We are a Smaller Reporting Company as defined by Rule 12b-2 of the Securities Exchange Act of 1934 and are not required to provide the information under this item.

ITEM 2. UNREGISTERED SALES OF EQUITY SECURITIES AND USE OF PROCEEDS.

None.

ITEM 3. DEFAULTS UPON SENIOR SECURITIES.

On August 29, 2025, noteholders Osher and Brio agreed to extend all of their outstanding notes to December 31, 2027 for original issue discount totaling $737,786.

ITEM 4. MINE SAFTEY DISCLOSURE.

Pursuant to Section 1503(a) of the Dodd-Frank Wall Street Reform and Consumer Protection Act, issuers that are operators, or that have a subsidiary that is an operator, of a coal or other mine in the United States are required to disclose in their periodic reports filed with the SEC information regarding specified health and safety violations, orders and citations, related assessments and legal actions, and mining-related fatalities from the Federal Mine Safety and Health Administration, or MSHA, under the Federal Mine Safety and Health Act of 1977, or the Mine Act. During the quarter ended June 30, 2025, we did not have any projects that were in production and as such, were not subject to regulation by MSHA under the Mine Act.

ITEM 5. OTHER INFORMITON.

During the quarter ended June 30, 2025, no director or officer of the Company adopted or terminated a “Rule 10b5-1 trading arrangement” or “non-Rule 10b5-1 trading arrangement,” as each term is defined in Item 408(a) of Regulation S-K.

Board of Directors and Officer Resignations

On July 31, 2025 Dr. Annette Marleau resigned as Chief Scientific Officer of the Company.

On August 8, 2025, Richa Nand and Michael Ryan notified the Company of their decision to resign from the Company’s Board of Directors, effective August 8, 2025. On August 7, 2025, Christopher Wetzel notified the Company of his decision to resign from the Board of Directors, effective August 7, 2025. The resignations were based on the Company’s discontinuation of directors’ and officers’ liability insurance coverage which expired on August 4, 2025.

Item 6. Exhibits.

Exhibit
Number		Description
1.1		Form of Underwriting Agreement**

3.1*		Amended and Restated Certificate of Incorporation, as filed with the Secretary of State of the State of Delaware

3.2*		Bylaws of the Registrant, as currently in effect (Filed as Exhibit 3.2 to the Registration Statement on Form S-1 filed by the Registrant on May 27, 2015, and incorporated herein by reference).

10.1*		Share Exchange Agreement dated August 25, 2020 (Filed as Exhibit 10.1 to the Current Report on Form 8-K filed by the Registrant on August 31, 2020 and incorporated herein by reference)

10.2*		Operating Lease (Filed as Exhibit 10.2 to the Registration Statement on Form S-1 filed by the Registrant on April 10, 2024, and incorporated herein by reference).

10.3*		Employment Agreement for Jeremy Ferrell (Filed as Exhibit 99.1 to the Current Report on Form 8-K filed by the Registrant on March 9, 2022 and incorporated herein by reference)

10.4*		January 2020 Financing Documents and Extensions (Filed as Exhibit 10.4 to the Registration Statement on Form S-1 filed by the Registrant on April 10, 2024, and incorporated herein by reference).

10.5*		June 23, 2020 Financing Documents (Filed as Exhibit 10.5 to the Registration Statement on Form S-1 filed by the Registrant on April 10, 2024, and incorporated herein by reference).

10.6*		September 17, 2020 Financing Documents (Filed as Exhibit 10.6 to the Registration Statement on Form S-1 filed by the Registrant on April 10, 2024, and incorporated herein by reference).

10.7*		Senior Convertible Debenture dated May 10, 2022 (Filed as Exhibit 10.7 to the Registration Statement on Form S-1 filed by the Registrant on April 10, 2024, and incorporated herein by reference).

10.8*		Warrant dated May 10, 2022 (Filed as Exhibit 10.8 to the Registration Statement on Form S-1 filed by the Registrant on April 10, 2024, and incorporated herein by reference).

10.9*		Warrant dated October 18, 2021 (Filed as Exhibit 10.9 to the Registration Statement on Form S-1 filed by the Registrant on April 10, 2024, and incorporated herein by reference).

10.10*		Senior Convertible Debenture dated March 23, 2022 (Filed as Exhibit 10.10 to the Registration Statement on Form S-1 filed by the Registrant on April 10, 2024, and incorporated herein by reference).

10.11*		Warrant dated March 23, 2022 (Filed as Exhibit 10.11 to the Registration Statement on Form S-1 filed by the Registrant on April 10, 2024, and incorporated herein by reference).

10.12*		Senior Convertible Debenture dated March 23, 2022 (Filed as Exhibit 10.12 to the Registration Statement on Form S-1 filed by the Registrant on April 10, 2024, and incorporated herein by reference).

10.13*		Warrant dated March 23, 2022 (Filed as Exhibit 10.13 to the Registration Statement on Form S-1 filed by the Registrant on April 10, 2024, and incorporated herein by reference).

10.14*		Senior Convertible Debenture dated April 28, 2022 (Filed as Exhibit 10.14 to the Registration Statement on Form S-1 filed by the Registrant on April 10, 2024, and incorporated herein by reference).

10.15*		Warrant dated April 28, 2022 (Filed as Exhibit 10.15 to the Registration Statement on Form S-1 filed by the Registrant on April 10, 2024, and incorporated herein by reference).

10.16*		June 1, 2022 Financing Documents (Filed as Exhibit 10.16 to the Registration Statement on Form S-1 filed by the Registrant on April 10, 2024, and incorporated herein by reference).

10.17*		June 22, 2022 Financing Documents (Filed as Exhibit 10.17 to the Registration Statement on Form S-1 filed by the Registrant on April 10, 2024, and incorporated herein by reference).

10.18*		Set of Form Documents for July 2022 Financing (Filed as Exhibit 10.18 to the Registration Statement on Form S-1 filed by the Registrant on April 10, 2024, and incorporated herein by reference).

10.19*		August 31, 2022 Financing Documents (Filed as Exhibit 10.19 to the Registration Statement on Form S-1 filed by the Registrant on April 10, 2024, and incorporated herein by reference).

10.20*		September 9, 2022 Financing Documents (Filed as Exhibit 10.20 to the Registration Statement on Form S-1 filed by the Registrant on April 10, 2024, and incorporated herein by reference).

10.21*		October 20, 2022 Financing Documents (Filed as Exhibit 10.21 to the Registration Statement on Form S-1 filed by the Registrant on April 10, 2024, and incorporated herein by reference).

10.22*		November 9, 2022 Financing Documents (Filed as Exhibit 10.22 to the Registration Statement on Form S-1 filed by the Registrant on April 10, 2024, and incorporated herein by reference).

10.23*		November 14, 2022 Financing Documents (Filed as Exhibit 10.23 to the Registration Statement on Form S-1 filed by the Registrant on April 10, 2024, and incorporated herein by reference).

10.24*		November 21, 2022 Financing Documents (Filed as Exhibit 10.24 to the Registration Statement on Form S-1 filed by the Registrant on April 10, 2024, and incorporated herein by reference).

10.25*		December 22, 2022 Financing Documents (Filed as Exhibit 10.25 to the Registration Statement on Form S-1 filed by the Registrant on April 10, 2024, and incorporated herein by reference).

10.26*		September 14, 2023 Financing Documents (Filed as Exhibit 10.26 to the Registration Statement on Form S-1 filed by the Registrant on April 10, 2024, and incorporated herein by reference).

21.1*		Subsidiaries of the Registrant (Filed as Exhibit 21.1 to the Registration Statement on Form S-1 filed by the Registrant on April 10, 2024, and incorporated herein by reference).

31.1***		Certification by Principal Executive Officer pursuant to Rule 13a-14(a)

32.1***		Certification by Principal Executive Officer pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002.

101.INS		Inline XBRL Instance Document

101.SCH		Inline XBRL Taxonomy Extension Schema Document

101.CAL		Inline XBRL Taxonomy Extension Calculation Linkbase Document

101.DEF		Inline XBRL Taxonomy Extension Definition Linkbase Document

101.LAB		Inline XBRL Taxonomy Extension Label Linkbase Document

101.PRE		Inline XBRL Taxonomy Extension Presentation Linkbase Document

104		Cover Page Interactive Data File (embedded within the Inline XBRL document)

*		Previously filed.

**		To be filed by amendment

***		Filed herewith

All references to Registrant’s Forms 8-K, 10-K and 10-Q include reference to File No. 000-55575

SIGNATURES

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.

	Sigyn Therapeutics, Inc. a Delaware corporation

Dated: September 5, 2025	By:	/s/ James Joyce
		James Joyce
		Chief Executive Officer and Director (Principal Executive Officer and Principal Financial and Accounting Officer)

Dated: September 5, 2025	By:	/s/ Craig Roberts
		Craig Roberts
		Chief Technology Officer and Director

Pursuant to the requirements of the Securities Exchange Act of 1934, this report has been signed below by the following persons on behalf of the registrant and in the capacities and on the dates indicated.

Signature	Title	Date

/s/ James Joyce	Chief Executive Officer and Director	September 5, 2025
James Joyce	(Principal Executive Officer and Principal Financial and Accounting Officer)

/s/ Craig Roberts	CTO and Director	September 5, 2025
Craig Roberts

/s/ Jim Dorst	Director	September 5, 2025
Jim Dorst

Filing Compare · Sigyn Therapeutics, Inc.