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Healthcare

Sigyn Therapeutics Inc.

09/05/2025 | Press release | Distributed by Public on 09/05/2025 13:49

Quarterly Report for Quarter Ending June 30, 2025 (Form 10-Q)

MANAGEMENT'S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS

You should read the following discussion of our financial condition and results of operations in conjunction with our financial statements and the notes included elsewhere in this Form 10-Q. The following discussion contains forward-looking statements that involve certain risks and uncertainties. Our actual results could differ materially from those discussed in these statements. Factors that could cause or contribute to these differences include those discussed below and elsewhere in this Form 10-Q and our Annual Report on Form 10-K for the year ended December 31, 2024 particularly under the "Risk Factors" and "Cautionary Note Regarding Forward-Looking Statements and Risk Factors Summary" sections.

Our Company

Sigyn Therapeutics, Inc. ("Sigyn", the "Company", "we," "us," or "our") is a development-stage company focused on creating therapeutic solutions that address unmet needs in global healthcare. Our corporate address is 2468 Historic Decatur Road, Suite 140, San Diego, California, 92106.

Sigyn Therapy™, our lead product candidate, is a broad-spectrum blood purification technology designed to treat pathogen-associated inflammatory disorders that are not addressed with approved drug therapies. Candidate treatment indications include endotoxemia and inflammation in end-stage renal disease (dialysis) patients, sepsis (a leading cause of hospital deaths), community acquired pneumonia (a leading cause of death among infectious diseases), and emerging pandemic threats.

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

Recent Developments

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.

Financing Transactions

Preferred Stock

The Company 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 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.

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 June 30, 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 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.

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).

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.

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 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 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 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).

Convertible Notes

Between January 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.

The remaining outstanding Notes are as follows:

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

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

The 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.

Extension of Notes

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.

Lease Termination

On 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.

Limited Operating History; Need for Additional Capital

There is limited historical financial information about us on which to base an evaluation of our performance. We cannot guarantee we will be successful in our business operations. Our business is subject to risks inherent in the establishment of a new business enterprise, including limited capital resources, and possible cost overruns due to increases in the cost of services. To become profitable and competitive, we must receive additional capital. We have no assurance that future financing will materialize. If that financing is not available, we may be unable to continue operations.

Business Overview

Sigyn Therapeutics, Inc. ("Sigyn", the "Company" "we," "us," or "our") develops medical devices to treat cancer and infectious disease disorders. We believe our lineup of therapeutic candidates is among the most expansive in the field of extracorporeal blood purification. To optimize the benefit of drugs to treat cancer, we invented the ImmunePrep^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.

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^TM 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 Therapy^TM 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)

Previous Infectious Disease Industry Achievements

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

Sigyn Therapy^TM Human Studies

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 helped 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^TM 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.

This use of Sigyn Therapy^TM in 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^TM to improve the delivery of chemotherapy, and ChemoPure^TM to extract off-target chemotherapy from the bloodstream to reduce treatment toxicity.

ImmunePrep^TM to 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^TM products that incorporate market-approved antibodies may have an accelerated pathway to potential market clearance.

ChemoPrep^TM to 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^TM aligns with the FDA "Project Optimus" initiative to minimize the toxicity of cancer drugs while maximizing patient benefit.

ChemoPure^TM to 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.

About Sigyn Therapy - Our Lead Therapeutic Candidate

Sigyn Therapy^TM Pre-Clinical Studies

Since 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.

Sigyn Therapy^TM Animal Studies

Subsequent to our pre-clinical in vitro studies, we disclosed the completion of in vivo animal studies. In these studies, Sigyn Therapy was administered via standard dialysis machines utilizing conventional blood-tubing sets, for periods of up to six hours to eight (8) porcine (pig) subjects, each weighing approximately 40-45 kilograms. The studies were comprised of a pilot phase (two subjects), which evaluated the feasibility of the study protocol in the first-in-mammal use of Sigyn Therapy; and an expansion phase (six subjects) to further assess treatment feasibility and refine pre-treatment set-up and operating procedures. There were no serious adverse events reported in any of the treated animal subjects. Of the eight treatments, seven were administered for the entire six-hour treatment period. One treatment was halted early due to the observation of a clot in the device, which was believed to be the result of a procedural deviation in the pre-treatment set-up. Important criteria for treatment feasibility - including hemodynamic parameters, serum chemistries and hematologic measurements - were stable across all subjects.

The studies were conducted by a clinical team at Innovative BioTherapies, Inc. ("IBT"), under a contract with the University of Michigan to utilize animal care, associated institutional review oversight, as well as surgical suite facilities located within the North Campus Research Complex. The treatment protocol of the study was reviewed and approved by the University of Michigan Institutional Animal Care and Use Committee ("IACUC").

The animal studies were conducted to correspond with FDA's best practice guidance. The number of animals enrolled in our study and the amount of data collected was based on the ethical and least burdensome principles that underly the FDA goal of using the minimum number of animals necessary to generate valid scientific data to demonstrate reasonable feasibility and performance of a medical device prior to human study consideration. A porcine animal model is a generally accepted model for the study of extracorporeal blood purification devices intended to treat infectious disease and inflammatory disorders. Regardless of these factors, FDA may require that we conduct additional animal studies.

Sigyn Therapy^TM Clinical Plan

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

Based on our previous experience in developing extracorporeal blood purification therapies, we believe we have collected sufficient data to support first-in-human studies of Sigyn Therapy. 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.

Sigyn Therapy Mechanism of Action

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

To support widespread implementation, Sigyn Therapy 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.

Incorporated within Sigyn Therapy is a "cocktail" of adsorbent components formulated to optimize the broad-spectrum reduction of therapeutic targets from the bloodstream. In the medical field, the term "cocktail" is a reference to the simultaneous administration of multiple drugs (a drug cocktail) with differing mechanisms of actions. While drug cocktails are emerging as potential mechanisms to treat cancer, they are life-saving countermeasures to treat HIV and Hepatitis-C viral infections. However, dosing of multi-drug agent cocktails is limited by toxicity and adverse events that can result from deleterious drug interactions.

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

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

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

Opportunities to Address Unmet Needs in Global Health

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

Untreatable Viral Pathogens

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

The first blood purification device to receive FDA Emergency-Use Authorization approval to treat a pandemic virus was the Hemopurifier to treat Ebola, which occurred under the leadership of our CEO. Subsequently, the first therapies to receive FDA Emergency-Use Authorization to treat Covid-19 were blood purification therapies from Terumo BCT, ExThera Medical Corporation, CytoSorbents, Inc., and Baxter Healthcare Corporation. In connection with these approvals, FDA published a statement that blood purification devices may be effective at treating patients with confirmed COVID-19 by reducing various pathogens, cytokines, and other inflammatory mediators from their bloodstream.

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

Additionally, as many infectious viruses are not addressed with a corresponding drug or vaccine, there may be an ongoing need for blood purification technologies that offer to reduce the severity of infection and mitigate the excess production of inflammatory cytokines (the cytokine storm) associated with high mortality in non-pandemic viral infections. Sigyn Therapy also aligns with government initiatives to support the development of broad-spectrum medical countermeasures that could help mitigate the impact of an emerging pandemic or bioterror threat yet may also have viability in established disease indications.

Antibiotic-Resistant Bacterial Infections

According to the U.S. Centers for Disease Control and Prevention ("CDC"), nearly three million individuals are infected with antibiotic resistant bacterial infections in the U.S. each year, which results in more than 35,000 deaths. The United Nations reported approximately 5 million deaths 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.

Endotoxemia

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

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

Sepsis

Sepsis is defined as a life-threatening organ dysfunction caused by a dysregulated host response to infection. In January of 2020, a report entitled; "Global, Regional, and National Sepsis Incidence and Mortality, 1990-2017: Analysis for the Global Burden of Disease Study," reported 48.9 million cases of sepsis and 11 million deaths in 2017. In that same year, an estimated 20.3 million sepsis cases and 2.9 million deaths were among children younger than 5-years old. The report included a reference that sepsis kills more people around the world than all forms of cancer combined. In the United States, sepsis was reported to be the most common cause of hospital deaths with an annual financial burden that exceeds $24 billion.

To date, more than 100 human studies have been conducted to evaluate the safety and efficacy of candidate drugs to treat sepsis. With one brief exception (Xigris, Eli Lilly), none of these studies resulted in a market cleared therapy. As sepsis remains beyond the reach of single-target drugs, there is a growing interest in multi-mechanism therapies that can simultaneously address both inflammatory and pathogen associated targets. Sigyn Therapy offers to addresses a broad-spectrum of pathogen sources and the resulting dysregulated cytokine production (the cytokine storm) that is a hallmark of sepsis.

Emerging Opportunity for Sigyn Therapy in Xenotransplantation

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

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

	1.	Gene-edited donor pigs to reduce pathogen accumulation in donor kidneys prior to their extraction for human transplantation. The feasibility of Sigyn Therapy^TM 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.

Devices to Optimize the Benefit of Cancer Therapies

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

ImmunePrep^TM to Optimize Immunotherapeutic Antibodies

ChemoPrep^TM to Optimize Chemotherapy Delivery

ChemoPure^TM to Reduce Chemotherapy Toxicity

Marketing and Sales

Our 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.

Intellectual Property

We own the intellectual property rights to pending royalty-free patents that have been assigned to us by our CEO and other employee inventors. We have also received a "Notice of Allowance" from the USPTO related to the use of Sigyn Therapeutics, Sigyn Therapy, and the protection of our corporate logo. We plan to continually expand our intellectual property portfolio and protect trade secrets that are not the subject of patent submissions. However, there is no assurance that the claims of current pending and future patent applications will result in issued patents. Pending changes in patent law, it is anticipated that each patent that becomes issued will have an enforceable life that will extend for a period of 20 years from the initial patent filing date (i.e., the priority date) and will expire at the end of such 20-year terms.

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

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

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

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

SYSTEM AND METHODS TO ENHANCE CHEMOTHERAPY DELIVERY AND REDUCE TOXICITY - International Patent Application No.: PCT/US2023/033878; Priority Date: 09/28/2022 - Inventor: James A. Joyce

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

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

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

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

DEVICES, SYSTEMS AND METHODS FOR THE BROAD-SPECTRUM REDUCTION OF PRO-INFLAMMATORY CYTOKINES IN BLOOD - International Patent Application No.: PCT/US2020/044223; Priority Date: 2019-08-01 - Inventors: James Joyce and Craig P. Roberts

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. Roberts

DEVICES, SYSTEMS AND METHODS FOR THE BROAD-SPECTRUM REDUCTION OF PRO-INFLAMMATORY CYTOKINES IN BLOOD - EP No.: 20757445.0; Priority Date: 2019-08-01 - Inventors: James A. Joyce and Craig P. Roberts

DEVICES, SYSTEMS AND METHODS FOR THE BROAD-SPECTRUM REDUCTION OF PRO-INFLAMMATORY CYTOKINES IN BLOOD - CA No.: 3,148,773; Priority Date: 2019-08-01 - Inventors: James A. Joyce and Craig P. Roberts

Government Regulation

In the United States, our medical devices are subject to regulation by the FDA. Should we seek to commercialize our products outside the United States, we expect to face comparable international regulatory oversight. The U.S. regulatory jurisdiction for extracorporeal blood purification therapies is the Center for Devices and Radiological Health ("CDRH"), the FDA branch that oversees the market approval of medical devices.

Based on published CDRH guidance, we believe that 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.

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

Should Sigyn Therapy or any of our other therapeutic candidates receive market clearance from FDA, we would need to comply with applicable laws and regulations that govern the development, testing, manufacturing, labeling, marketing, storage, distribution, advertising and promotion, and post-marketing surveillance reporting for medical devices. Failure to comply with these applicable requirements may subject a device and/or its manufacturer to a variety of administrative sanctions, such as issuance of warning letters, import detentions, civil monetary penalties and/or judicial sanctions, such as product seizures, injunctions and criminal prosecution. Our failure to comply with any of these laws and regulations could have a material adverse effect on our operations.

The Pre-market Approval Pathway

A pre-market approval ("PMA") application must be submitted to FDA for Class III devices requiring a PMA. The PMA application process is more demanding than the 510(k)-pre-market notification process. A PMA application must be supported by extensive data, including but not limited to technical, preclinical, clinical trials, manufacturing and labeling to demonstrate to the FDA's satisfaction reasonable evidence of safety and effectiveness of the device.

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

Although the FDA is not bound by the advisory panel decision, the panel's recommendations are important to the FDA decision making process. In addition, the FDA may conduct a preapproval inspection of the manufacturing facility to ensure compliance with the Quality System Regulation, or QSR. The agency also may inspect one or more clinical sites to assure compliance with FDA's regulations.

Upon completion of the PMA review, the FDA may: (i) approve the PMA which authorizes commercial marketing with specific prescribing information for one or more indications, which can be more limited than those originally sought; (ii) issue an approvable letter which indicates the FDA's belief that the PMA is approvable and states what additional information the FDA requires, or the post-approval commitments that must be agreed to prior to approval; (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.

Clinical Trials

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

Manufacturing and Procurement

At 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.

We have also established relationships with industry vendors that provide components necessary to manufacture Sigyn Therapy. Should the relationship with an industry vendor be interrupted or discontinued, we believe that alternate component suppliers can be identified to support continued manufacturing. However, delays related to interrupted or discontinued vendor relationships could adversely impact our business.

Research and Product Development

To date, we have outsourced much of 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.

Competition

Our therapeutic candidates provide a novel approach and are not similar to other products in the marketplace. However, there are there may be medical device or pharmaceutics companies that may develop products that could compete directly with our therapeutic candidates. If these companies develop competing products, they have far greater resources to support the clinical advancement and post approval marketing of their products within the medical industry than we do.

Environmental Laws and Regulations

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

Overview of Presentation

The following Management's Discussion and Analysis ("MD&A") or Plan of Operations includes the following sections:

	●	Results of Operations

	●	Liquidity and Capital Resources

	●	Capital Expenditures

	●	Going Concern

	●	Critical Accounting Policies

	●	Off-Balance Sheet Arrangements

General and administrative expenses consist primarily of personnel costs and professional fees required to support our operations and growth.

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

Results of Operations

Three Months Ended June 30, 2025 Compared to Three Months Ended June 30, 2024

The following 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.

	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 Revenues

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

Cost of Sales

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

Operating expenses

Operating expenses decreased by $133,292, or 22.1%, to $469,513 for three months ended June 30, 2025 from $602,805 for the three months ended June 30, 2024 primarily due to decreases in research and development costs of $232,947, depreciation costs of $1,364, rent expense of $12,460, professional fees of $16,961, investor relations costs of $3,347, and general and administration costs of $455, offset primarily by increases in compensation costs of $85,576, consulting fees of $29,835, insurance costs of $5,386, travel costs of $945, and stock based compensation of $12,500, as a result of adding administrative infrastructure for our anticipated business development.

For the three months ended June 30, 2025, we had marketing expenses of $8, research and development costs of $7,482, stock based compensation of $50,000, and general and administrative expenses of $412,023 primarily due to professional fees of $16,949, compensation costs of $265,423, rent expense of $6,832, investor relations costs of $6,456, consulting fees of $63,335, insurance expense of $49,987, travel costs of $945, and general and administration costs of $2,096, as a result of adding administrative infrastructure for our anticipated business development.

For 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.

Other Expense

Other expense for the three months ended June 30, 2025 totaled $981,674 primarily due to interest expense of $42,175 in conjunction with accretion of debt discount, interest expense of $81,017 in conjunction with accretion of original issuance discount, interest expense of $873, modification of warrants of $17,505, inducement of preferred shares of $845,901, and other income of $5,797, compared to other expense of $259,578 primarily due to interest expense of $116,737 in conjunction with accretion of debt discount, interest expense of $142,272 in conjunction with accretion of original issuance discount, and interest expense of $569.

Net loss before income taxes

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.

Assets and Liabilities

Assets were $51,759 as of June 30, 2025. Assets consisted primarily of cash of $459, other current assets of $1,300, and other assets of $50,000. Liabilities were $5,489,388 as of June 30, 2025. Liabilities consisted primarily of accounts payable of $729,846, accrued payroll and payroll taxes of $2,186,086, other current liabilities of $3,408, convertible notes of $2,307,986, net of $181,719 of unamortized debt discount and debt issuance costs, and short term promissory notes of $262,062, net of $61,938 of unamortized debt discount and debt issuance costs.

Six Months Ended June 30, 2025 Compared to Six Months Ended June 30, 2024

The following discussion represents a comparison of our results of operations for the six months ended June 30, 2024 and 2023. 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.

	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	)

Net Revenues

For the six months ended June 30, 2024 and 2023, we had no revenues.

Cost of Sales

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

Operating expenses

Operating expenses 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, investor relations costs of $2,725, 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 consulting fees of $44,710, compensation costs of $242,640, stock based compensation of $25,000, and travel costs of $945, as a result of adding administrative infrastructure for our anticipated business development.

For the six months ended June 30, 2025, we had marketing expenses of $184, research and development costs of $16,323, stock based compensation of $100,000, and general and administrative expenses of $899,065 primarily due to professional 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.

For the six months ended June 30, 2024, we had marketing expenses of $346, research and development costs of $473,022, stock based compensation of $75,000, and general and administrative expenses of $684,406 primarily due to professional fees of $79,314, compensation costs of $357,958, rent expense of $38,773, depreciation costs of $2,885, investor relations costs of $22,534, consulting fees of $56,000, insurance expense of $116,938, and general and administration costs of $10,004, as a result of adding administrative infrastructure for our anticipated business development.

Other Expense

Other expense 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.

Net loss before income taxes

Net loss before income taxes for the six 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.

Liquidity and Capital Resources

Going Concern

The accompanying financial statements have been prepared assuming the Company will continue as a going concern, which contemplates, among other things, the realization of assets and satisfaction of liabilities in the normal course of business. The Company had an accumulated deficit of $16,801,475 at June 30, 2025, had a working capital deficit of $5,487,629 at June 30, 2025, had net losses of $1,451,187 and $2,119,751, and $862,383 and $1,620,471 for the three and six months ended June 30, 2025 and 2024, respectively, and net cash used in operating activities of $446,882 and $418,406 for the six months ended June 30, 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 condensed consolidated financial statements do not include any adjustments that might be necessary if we are unable to continue as a going concern.

General - Overall, we had a decrease in cash flows for the six months ended June 30, 2025 of $11,685 resulting from cash used in operating activities of $446,882, offset partially by cash provided by financing activities of $435,197.

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

	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

Cash Flows from 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 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.

For the six months ended June 30, 2024, net cash used in operations was primarily due to a net loss of $1,620,471 and the changes in operating assets and liabilities of $738,564, primarily due to the changes in accounts payable of $26,718, other current assets of $13,641, accrued payroll and payroll taxes of $701,399, offset partially by the change in other current liabilities of $3,194. In addition, net cash used in operating activities includes adjustments to reconcile net profit from depreciation 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.

Cash Flows from Investing Activities - For the six months ended June 30, 2025 and 2024, the Company had no cash flows from investing activities.

Cash Flows from Financing Activities - For the six months ended June 30, 2025, net cash provided by financing was $435,197, due to proceeds from short term convertible notes of $425,197 and proceeds from short-term promissory notes of $10,000, compared to cash provided by financing activities of $460,360, due to proceeds from short term convertible notes of $470,360 and advance from shareholder of $35,000, and repayments of advance from shareholder of $45,000.

Financing - We expect that our current working capital position, together with our expected future cash flows from operations will be insufficient to fund our operations in the ordinary course of business, anticipated capital expenditures, debt payment requirements and other contractual obligations for at least the next twelve months. 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.

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.

Regulation D

Convertible Notes Payable

In fiscal 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 for each $0.90909 paid by the noteholders and (ii) five-year Common Stock Purchase Warrants ("Warrants") to purchase up to an aggregate of 228,208 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.

In September 2024, holders converted $474,793 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.

Capital Expenditures

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

Lease Termination

Fiscal year end

Our fiscal year end is December 31.

Critical Accounting Policies

The SEC has defined a company's critical accounting policies as the ones that are most important to the portrayal of the Company's financial condition and results of operations and which require the Company to make its most difficult and subjective judgments, often as a result of the need to make estimates of matters that are inherently uncertain. Based on this definition, we have identified the critical accounting policies and judgments addressed below.

The following are deemed to be the most critical accounting policies affecting the Company.

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: 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, 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.

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.

Future Contractual Obligations and Commitments

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

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

Off-Balance Sheet Arrangements

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

	●	a retained or contingent interest in assets transferred to the unconsolidated entity or similar arrangement that serves as credit;

	●	liquidity or market risk support to such entity for such assets;

	●	an obligation, including a contingent obligation, under a contract that would be accounted for as a derivative instrument; or

	●	an obligation, including a contingent obligation, arising out of a variable interest in an unconsolidated entity that is held by, and material to us, where such entity provides financing, liquidity, market risk or credit risk support to or engages in leasing, hedging, or research and development services with us.

Inflation

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

Sigyn Therapeutics Inc. published this content on September 05, 2025, and is solely responsible for the information contained herein. Distributed via SEC EDGAR on September 05, 2025 at 19:49 UTC. If you believe the information included in the content is inaccurate or outdated and requires editing or removal, please contact us at [email protected]

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