Executive Summary / Key Takeaways

• Sigyn Therapeutics (SIGY) is a development-stage biotechnology company pioneering a suite of extracorporeal blood purification devices, notably Sigyn Therapy™, aimed at addressing critical unmet needs in infectious diseases, sepsis, and cancer treatment.
• The company's core technological differentiation lies in its broad-spectrum blood purification capabilities, validated to extract a wide array of pathogens, toxins, and inflammatory mediators, offering a novel approach where drug therapies often fail.
• Despite promising preclinical validation and a strategic focus on high-value indications like End-Stage Renal Disease (ESRD) and xenotransplantation, SIGY currently generates no revenue and faces significant financial challenges, including a substantial accumulated deficit and a "going concern" warning.
• Recent financing activities, including convertible notes and a Regulation D offering, are critical for funding operations and advancing its Class III medical devices through rigorous FDA Pre-Market Approval (PMA) pathways.
• Investors should weigh the high-risk, high-reward profile, considering the potential for disruptive technology against the backdrop of severe liquidity constraints, recent management resignations, and the lengthy, capital-intensive regulatory approval process.

The Unmet Imperative: Redefining Disease Treatment with Extracorporeal Therapies

Sigyn Therapeutics, Inc. (SIGY) is a development-stage company dedicated to creating transformative medical devices for some of the most challenging conditions in global healthcare: cancer and infectious diseases. At its core, SIGY is advancing a lineup of extracorporeal blood purification technologies, a field where its management team brings a history of innovation, including a device that previously earned FDA Emergency Use Authorization for Ebola and two Breakthrough Device designations. This foundational expertise underpins the company's ambitious strategy to tackle conditions currently beyond the reach of conventional drug therapies.

The global healthcare landscape is fraught with persistent challenges. Untreatable viral pathogens, antibiotic-resistant bacterial infections, and the devastating impact of sepsis—which claims more lives globally than all forms of cancer combined—represent immense unmet medical needs. In the United States alone, nearly three million individuals contract antibiotic-resistant bacterial infections annually, leading to over 35,000 deaths. Sepsis, the leading cause of hospital deaths, carries an annual financial burden exceeding $24 billion. Furthermore, the critical shortage of transplantable human organs, with approximately 90,000 individuals awaiting kidney transplants in the U.S. against fewer than 30,000 procedures performed each year, highlights another area ripe for innovative solutions. These broad industry trends underscore the significant market opportunity that Sigyn Therapeutics aims to address with its specialized device platforms.

Technological Edge: Broad-Spectrum Purification and Targeted Cancer Optimization

Sigyn Therapeutics' investment thesis is deeply rooted in its differentiated technology platforms. The company's lead therapeutic candidate, Sigyn Therapy™, is a broad-spectrum blood purification technology designed to extract deadly pathogens and toxins while simultaneously dampening excessive immune responses. This device has been validated in preclinical in vitro studies to extract a wide array of therapeutic targets from human blood plasma, including viral pathogens (such as SARS-CoV-2), bacterial toxins (endotoxin, peptidoglycan, lipoteichoic acid), hepatic toxins (ammonia, bile acid, bilirubin), and pro-inflammatory cytokines (TNF alpha, IL-1b, IL-6).

The technical prowess of Sigyn Therapy™ is notable. It is a single-use disposable device, 325mm long, containing polyethersulphone hollow fibers with a median pore size of 200 nanometers. This design allows plasma and therapeutic targets smaller than 200nm to flow into an extra-lumen space, interacting with a "cocktail of adsorbent components" that collectively provide over 200,000 square meters (50 acres) of surface area for adsorption. This mechanism enables the processing of an average person's entire bloodstream approximately fifteen times during a single four-hour treatment, demonstrating a high level of efficiency in target removal. The "so what" for investors is the potential for a highly effective, multi-pronged treatment for complex inflammatory and infectious conditions that current drug-based approaches often fail to adequately address.

Beyond infectious diseases, SIGY is developing a suite of medical devices to optimize cancer therapies. The ImmunePrep™ platform aims to enhance the performance of immunotherapeutic antibodies, which are often poorly delivered to cancer targets. By immobilizing therapeutic antibodies in an extracorporeal circuit, ImmunePrep™ sweeps "antibody decoys" out of the bloodstream, thereby improving targeted antibody delivery and reducing circulating cancer targets. Products incorporating market-approved antibodies may benefit from an accelerated FDA pathway. Complementing this, ChemoPrep™ is designed to improve chemotherapy delivery by reducing tumor-derived exosomes that disrupt treatment, aligning with the FDA's Project Optimus initiative to minimize toxicity. ChemoPure™ further reduces chemotherapy toxicity by extracting off-target chemotherapy from the bloodstream. These cancer-focused technologies, unlike Sigyn Therapy™, are intended for use on portable blood processing systems, offering flexibility in clinical settings. The strategic intent behind these platforms is to significantly improve the efficacy and safety of existing cancer drugs, potentially expanding their utility and patient benefit.

Competitive Landscape: Innovation Against Established Giants

Sigyn Therapeutics operates in a competitive environment, though its therapeutic candidates are described as providing a novel approach not directly similar to other products currently in the marketplace. However, the company acknowledges the presence of medical device and pharmaceutical companies with significantly greater resources that could develop competing products.

Direct competitors in the broader blood purification and critical care space include established players like CytoSorbents Corporation (CTS), Baxter International Inc. (BAX), and Fresenius Medical Care AG & Co. KGaA (FMS). CytoSorbents, for instance, focuses on cytokine adsorption, while Baxter and Fresenius are global leaders in renal care and extracorporeal therapies. SIGY's multi-target approach with Sigyn Therapy™ potentially offers a more comprehensive solution for complex inflammatory disorders compared to the more specialized or broader, less targeted offerings of its rivals. While SIGY may lead in the speed of innovation for its specific, multi-mechanism approach, it significantly lags these larger competitors in terms of market presence, operational scale, and financial strength. For example, SIGY's current lack of revenue and substantial losses stand in stark contrast to the established revenue streams and profitability (or path to profitability) of companies like CTS, BAX, and FMS.

Indirect competition also arises from pharmaceutical treatments for sepsis and advanced immunotherapies. The stringent regulatory requirements and high R&D costs in the medical device industry act as significant barriers to entry, which could protect SIGY's innovations if successfully commercialized but also pose substantial financial hurdles for the company itself. SIGY's reliance on third-party Contract Manufacturing Organizations (CMOs) and outsourced R&D also introduces supply chain and operational risks that larger, integrated competitors might mitigate more effectively.

Financial Performance and Liquidity: A Development-Stage Reality

As a development-stage company, Sigyn Therapeutics has not generated any revenue since its inception. For the three months ended June 30, 2025, the company reported a net loss of $1.45 million, an increase from $862,383 in the same period of 2024. The net loss for the six months ended June 30, 2025, was $2.12 million, compared to $1.62 million in the prior year period. This escalating net loss is primarily attributable to significant "other expenses," including the inducement of preferred shares and modification of warrants, rather than core operational increases.

Operating expenses, however, showed a positive trend, decreasing by 22.10% to $469,513 for the three months ended June 30, 2025, and by 17.60% to $1.02 million for the six months ended June 30, 2025, compared to the respective prior-year periods. These reductions were largely driven by lower research and development costs, depreciation, and professional fees, partially offset by increased compensation, consulting, and stock-based compensation as the company built administrative infrastructure for anticipated business development.

Liquidity remains a critical concern. As of June 30, 2025, SIGY held only $459 in cash and had a working capital deficit of $5.49 million. Net cash used in operating activities for the six months ended June 30, 2025, was $446,882. Management explicitly states that current working capital and expected future cash flows will be insufficient to fund operations for at least the next twelve months, raising "substantial doubt about the Company’s ability to continue as a going concern."

The company has actively pursued financing. Between January 2020 and June 2025, it raised approximately $4.93 million in cash through Original Issue Discount Senior Convertible Debentures. A Regulation D offering initiated in January 2025 generated $345,197 in cash by June 30, 2025. Subsequent to the quarter end, in August 2025, SIGY secured a Convertible Note Purchase Agreement with Lambda Venture Partners, LLC for up to $500,000 in proceeds, with $100,000 already received. Crucially, noteholders Osher and Brio agreed to extend all their outstanding notes to December 31, 2027, for an original issue discount of $737,786, providing some relief. However, several convertible notes totaling $485,350 from Osher and Brio matured in early 2025 and are currently in default, with restructuring discussions ongoing.

Outlook and Risks: A High-Stakes Path Forward

Sigyn Therapeutics' immediate future hinges on its ability to advance its lead candidate, Sigyn Therapy™, into human clinical studies. The company has drafted an Investigational Device Exemption (IDE) for submission to the FDA, proposing first-in-human feasibility studies in 12-15 End-Stage Renal Disease (ESRD) patients with endotoxemia and inflammation. This is a critical step, as all of SIGY's therapeutic candidates are expected to be classified as Class III medical devices, requiring a demanding Pre-Market Approval (PMA) pathway involving extensive preclinical and human clinical trials. There is no assurance that the FDA will approve the proposed feasibility study or ultimately grant market approval.

The company's outlook is further complicated by significant internal control weaknesses, including a lack of comprehensive entity-level controls and insufficient segregation of duties. Moreover, the resignations of the Chief Scientific Officer and three Board members in July and August 2025, primarily due to the discontinuation of directors and officers liability insurance, highlight operational vulnerabilities and potential challenges in governance and leadership stability. Management plans to purchase approximately $30,000 in equipment over the next twelve months for business expansion, a modest capital expenditure in the context of its overall needs.

The "so what" for investors is clear: SIGY represents a speculative investment in potentially groundbreaking medical technology. Its success is entirely dependent on securing substantial additional capital, successfully navigating complex and lengthy regulatory approval processes, and effectively commercializing its innovative devices in highly competitive markets.

Conclusion

Sigyn Therapeutics stands at a pivotal juncture, holding intellectual property for novel extracorporeal blood purification technologies that could fundamentally alter the treatment paradigms for severe infectious diseases, sepsis, and cancer. The company's innovative approach, particularly with Sigyn Therapy™ and its multi-target extraction capabilities, addresses critical unmet medical needs with potentially superior efficacy compared to existing solutions. This technological differentiation forms the core of its long-term investment thesis, promising significant value creation if successfully brought to market.

However, the path forward is fraught with considerable risk. SIGY's current financial state, marked by a lack of revenue, substantial losses, and a "going concern" warning, underscores the immense capital requirements inherent in medical device development. While recent financing efforts and debt extensions offer temporary reprieve, the company's ability to secure sufficient, non-dilutive funding and overcome regulatory hurdles will be paramount. For discerning investors, SIGY presents a high-risk, high-reward opportunity, where the potential for disruptive innovation must be carefully balanced against the formidable financial and operational challenges that lie ahead. The successful execution of its clinical development plan and strategic financing will be the ultimate determinants of its ability to translate technological promise into tangible shareholder value.