10-Q: Sigyn Therapeutics Shifts Focus to CardioDialysis, Reports Q3 2025

Sigyn Therapeutics is pivoting its lead therapy, Sigyn CardioDialysis, to target cardiovascular disease in ESRD patients, while reporting a reduced net loss and operating expenses for Q3 2025, despite ongoing going concern issues and increased debt.

Summary

• Shifted the primary therapeutic focus of Sigyn TherapyTM to CardioDialysisTM for cardiovascular disease, particularly in end-stage renal disease (ESRD) patients, filing a trademark application on November 6, 2025.
• Reported a net loss of $(578,503) for the three months ended September 30, 2025, an improvement from $(1,196,923) in the prior year period.
• The nine-month net loss decreased to $(2,698,254) in 2025 from $(2,817,394) in 2024.
• Operating expenses significantly decreased by 52.2% to $386,528 for the three months ended September 30, 2025, and by 31.3% to $1,402,100 for the nine months ended September 30, 2025.
• Research and development costs saw a substantial reduction to $46,004 for the nine months ended September 30, 2025, from $679,183 in the prior year.
• Cash balance increased to $85,571 as of September 30, 2025, from $12,144 at December 31, 2024.
• Accumulated deficit grew to $(17,379,978) as of September 30, 2025.
• Total liabilities increased to $6,052,780 as of September 30, 2025, from $4,671,343 at December 31, 2024.
• Identified material weaknesses in internal control over financial reporting, including lack of risk assessment, comprehensive entity-level controls, adequate system/manual controls, and segregation of duties.
• Three non-executive directors resigned from the Board in August 2025 due to the discontinuation of directors and officers liability insurance coverage.

Sentiment

Score: 3

Explanation: While there's a strategic pivot and some expense reduction, the severe going concern warning, increasing overall liabilities, continued lack of revenue, and board resignations due to insurance issues paint a very challenging picture. The capital raises are essential for survival, not growth, and the company's long-term viability remains highly uncertain.

Positives

• Net loss decreased for both the three months (to $(578,503)) and nine months (to $(2,698,254)) ended September 30, 2025, compared to the prior year periods.
• Operating expenses significantly reduced by 52.2% for the three months and 31.3% for the nine months ended September 30, 2025, primarily driven by lower research and development costs.
• Cash balance increased to $85,571 as of September 30, 2025, from $12,144 at December 31, 2024.
• Working capital deficit decreased from $(4,593,743) at December 31, 2024, to $(3,903,920) at September 30, 2025.
• Strategic shift of CardioDialysisTM to cardiovascular disease in ESRD patients targets a larger market opportunity and potentially less burdensome clinical studies due to an FDA-approved device precedent.
• Successful completion of pre-clinical in vitro and in vivo animal studies for CardioDialysisTM with no serious adverse events reported in animal subjects.
• Extension of outstanding convertible notes from Osher Capital Partners LLC and Brio Capital Master Fund, Ltd. to December 31, 2027.

Negatives

• No revenues generated since inception, indicating a lack of commercialized products.
• Accumulated deficit increased to $(17,379,978) as of September 30, 2025.
• Total liabilities significantly increased to $6,052,780 as of September 30, 2025, from $4,671,343 at December 31, 2024.
• Net cash used in operating activities increased to $(646,208) for the nine months ended September 30, 2025, from $(582,218) in the prior year, indicating a higher cash burn.
• Significant increase in 'Other expense' for the nine months ended September 30, 2025, primarily due to $845,901 for inducement of preferred shares and a new derivative liability of $181,362.
• Three non-executive directors resigned from the Board due to the discontinuation of directors and officers liability insurance coverage.
• Identified material weaknesses in internal control over financial reporting, which have not yet been remediated.

Risks

• Substantial doubt about the ability to continue as a going concern due to an accumulated deficit of $17,379,978, a working capital deficit of $3,903,920, persistent net losses, and negative operating cash flows.
• Inability to raise additional capital through a public offering or asset sale transaction on acceptable terms, which is critical for continued operations.
• Risks relating to the successful development of product candidates, including CardioDialysis and cancer therapies, and the ability to successfully complete planned clinical studies.
• Uncertainty regarding FDA approval for the initiation of proposed feasibility studies or market approval for CardioDialysisTM, with the possibility of requiring additional animal studies.
• Reliance on third-party organizations for clinical development studies and industry vendors for components, with potential adverse impacts if relationships are interrupted or discontinued.
• Competition from medical device or pharmaceutical companies that may have greater resources to support clinical advancement and post-approval marketing.
• Inherent limitations in internal control systems, including potential for faulty judgments, errors, and lack of segregation of duties, increasing the risk of financial misstatement.

Future Outlook

The company intends to raise additional funds through a public offering or an asset sale transaction to support its operations and address its going concern issues. It plans to submit an Investigational Device Exemption (IDE) application to the FDA for first-in-human feasibility studies of CardioDialysisTM in ESRD patients. The company will continue to evaluate acquisitions and investments that complement its business, but acknowledges that obtaining such financing on commercially reasonable terms may be difficult due to the ongoing global economic crisis.

Management Comments

• "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."
• "We believe it will be significantly less burdensome to enroll cardiovascular disease subjects into pivotal efficacy studies that will be required for FDA market approval."
• "We consider our potential value to the dialysis industry as a majority of their patients die from cardiovascular disease related events."
• "We believe CardioDialysis could improve and extend the quality of life of ESRD patients who rely on dialysis for survival."
• "We believe CardioDialysis has an advantage of being deployed for use on dialysis machines already located in hospitals and clinics around the world."
• "We believe we have collected sufficient data to support the initiation of a CardioDialysisTM human feasibility study."

Industry Context

The strategic shift of Sigyn Therapeutics' lead therapy, CardioDialysis, to target cardiovascular disease in end-stage renal disease (ESRD) patients positions the company in a substantial market where cardiovascular disease is the leading cause of death. This approach leverages the existing global dialysis machine infrastructure, potentially overcoming the limited delivery infrastructure challenges faced by current FDA-approved devices like Lipoprotein Apheresis. The company aims to address significant unmet medical needs in ESRD patients, where traditional statin therapies offer limited clinical benefit and high lipoprotein(a) levels are prevalent, while also controlling dialysis-induced inflammatory responses.

Comparison to Industry Standards

• CardioDialysis aims to reduce Major Adverse Cardiovascular Events (MACE) by targeting inflammatory molecules and cholesterol-transporting lipoproteins, similar to Lipoprotein Apheresis (LA).
• LA has demonstrated MACE reduction by 59% to 95% across 11 studies encompassing 1,387 treated patients, while pharmaceutical statins are reported to reduce MACE by 20% to 45%. CardioDialysis seeks to offer a broad-spectrum approach that may surpass these outcomes.
• LA's clinical adoption is constrained by a limited delivery infrastructure, with fewer than 60 specialized apheresis centers in the United States. In contrast, CardioDialysis is designed to be deployed on an estimated 150,000 existing dialysis machines in over 7,500 U.S. kidney dialysis clinics, offering a significant infrastructure advantage.
• The company estimates the annual market for MACE-reducing therapies to exceed $100 billion, indicating a large target market for CardioDialysis.
• CardioDialysis aims to address unique cardiovascular disease challenges in ESRD patients, where statins offer limited clinical benefit and circulating levels of cholesterol-transporting lipoprotein(a) are two to four times higher than in the general population.

Management Changes

Corporate Governance

Legal Proceedings

• Not currently involved in legal proceedings that could reasonably be expected to have a material adverse effect on the business, prospects, financial condition or results of operations.

Related Party Transactions

• Mr. Joyce, the Chief Executive Officer, receives an annual base salary of $455,000, plus bonus compensation not to exceed 50% of his salary.
• The company has agreed to maintain a beneficial ownership target of 9% for Mr. Joyce.
• Compensation expense for Mr. Joyce was $113,750 for the three months and $341,250 for the nine months ended September 30, 2025 and 2024, respectively.

Stakeholder Impact

• Shareholders face significant dilution risk from ongoing convertible debt and warrant issuances. The increased accumulated deficit and explicit going concern warning pose substantial risk to investment value. Board resignations due to D&O insurance lapse could signal governance concerns and further erode investor confidence.
• Employees may experience uncertainty and instability given the going concern warning and the continuous need for additional capital to sustain operations.
• Creditors face high risk due to the company's accumulated deficit, working capital deficit, and heavy reliance on future financing. The substantial convertible notes and promissory notes represent significant obligations with uncertain repayment prospects.
• Future customers, particularly ESRD patients, could potentially benefit from life-saving therapies if CardioDialysis is successfully developed and commercialized, addressing a critical unmet medical need.

Next Steps

• Submit an Investigational Device Exemption (IDE) application to the FDA for first-in-human feasibility studies of CardioDialysisTM.
• Conduct first-human feasibility studies of CardioDialysisTM in 12-15 ESRD subjects at three dialysis clinic site locations.
• Expand intellectual property portfolio and protect trade secrets related to its therapeutic candidates.
• Establish cGMPs compliant manufacturing through Contract Manufacturing Organizations (CMO) for CardioDialysis and other product candidates.
• Implement changes to enhance and improve internal control over financial reporting, including appointing additional qualified personnel and modifying financial controls.
• Management intends to raise additional funds by way of a public offering or an asset sale transaction.
• Continue to evaluate acquisitions of and/or investments in products, technologies, capital equipment or improvements or companies that complement the business.

Key Dates

Recommendation

The company faces severe financial distress, explicitly stating 'substantial doubt about the Company's ability to continue as a going concern.' This is compounded by a significant accumulated deficit, increasing total liabilities, and persistent negative operating cash flows. While the strategic pivot to CardioDialysis for cardiovascular disease is a positive development, it is a long-term play with no immediate revenue prospects. The resignations of multiple board members due to a lapse in D&O insurance highlight critical governance and operational risks. The continuous reliance on dilutive convertible debt and the explicit warning about the difficulty of obtaining future financing make the company's survival highly uncertain. Investors face extreme risk of capital loss.

Keywords

CardioDialysis, cardiovascular disease, ESRD, blood purification, dialysis therapy, cancer therapies, SEC filing, 10-Q, biotechnology, medical device, clinical trials, FDA approval, convertible notes, going concern, financial results