Sigyn Therapeutics, Inc. · OTC:SIGY
Sigyn Therapeutics — Investor Presentation (July 2025)
25 slides from Sigyn Therapeutics's investor presentation, July 2025
Slide 1: July 2025 Investor Presentation
July 2025 Jim Joyce 1 CEO, Inventor
Slide 2: Forward-Looking Statements
FORWARD-LOOKING STATEMENTS The following presentation is for informational purposes only and is not an offer to sell or a solicitation of an offer to buy any securities of Sigyn Therapeutics, Inc. (“Sigyn”). All statements in this presentation, other than statements of historical fact, are forward-l
Slide 3: Next-Generation Blood Purification Therapies
Next-Generation Blood Purification Therapies 3
Slide 4: Focus is the Creation of Value Through Clinical Progression
Focus is the Creation of Value Through Clinical Progression Ø Sigyn TherapyTM addresses life-threatening inflammatory disorders - including sepsis, the #1 cause of hospital deaths - $62 billion annual cost to U.S. Healthcare system Joint Venture Initiatives to Optimize the Benefit of Cancer Therapie
Slide 5: The Sigyn Team
The Sigyn Team Ø Includes extracorporeal industry thought leaders across Management, the Company’s Board of Directors and Science Advisory Board Ø Management oversaw development of first blood purification device to receive two FDA Breakthrough Designations and the first device to receive FDA market
Slide 6: Sigyn Therapy
Sigyn TherapyTM Designed to address life-threatening inflammatory disorders with no FDA-approved treatments First-in-Mammal Studies at University of Michigan 6
Slide 7: Notable Blood Purification Therapies Being Advanced by Public Companies
Notable Blood Purification Therapies Being Advanced by Public Companies Ø CytoSorb Cytokine Clearance Device (CytoSorbents Corporation) Ø PMX Endotoxin Clearance Device (Spectral Medical) Current Market Cap ~$250m Ø The Hemopurifier – Broad-Spectrum Clearance of Viral Pathogens (Aethlon Medical) “Wo
Slide 8: Sigyn Therapy: One Device Addressing Multiple Targets
Sigyn TherapyTM One Device Able to Address Ø Inflammatory Cytokines Ø Bacterial Toxins (including endotoxin) Ø Viral Pathogens 8
Slide 9: Sigyn Therapy First-In-Industry Attributes
Sigyn TherapyTM First-In-Industry Attributes Ø Deployed on dialysis and CRRT machines already located in hospitals and clinics Ø Highly Efficient – bloodstream processed ~15 times during a four-hour treatment Ø Immense Capacity - incorporates an adsorbent formulation with ~200,000 M2 of surface area
Slide 10: FDA Breakthrough Device Initiatives
Sigyn TherapyTM FDA Breakthrough Device Initiatives Target Treatment Indications: Ø Sepsis Ø Endotoxemia w/ concurrent inflammation in End-Stage Renal Disease (ESRD) patients 10
Slide 11: Criterion for a FDA Breakthrough Device Designation
Criterion for a FDA Breakthrough Device Designation ü Offers a treatment for a life-threatening or irreversibly debilitating human disease or condition ü No approved or cleared alternatives exist ü Device availability is in the best interest of patients 11
Slide 12: End-Stage Renal Disease Endotoxemia & Inflammation
End-Stage Renal Disease (ESRD) Endotoxemia & Inflammation Ø 550,000+ ESRD patients receive ~85 million dialysis treatments in the U.S. each year Ø Annual mortality rate is ~20% Ø Cardiovascular Disease & Sepsis are leading causes of early death (~70%) Ø Endotoxemia and concurrent inflammation drive
Slide 13: Potential Value to the Dialysis Industry?
Potential Value to the Dialysis Industry? 13
Slide 14: Two Organizations Dominate The U.S. Dialysis Industry
Two Organizations Dominate The U.S. Dialysis Industry 14
Slide 15: Ø ~200,000 U.S. ESRD patients Ø Average annual revenue per-patient is ~$60,000 Ø ~$1
Ø ~200,000 U.S. ESRD patients Ø Average annual revenue per-patient is ~$60,000 Ø ~$1 Billion of increased revenue per-month of extended ESRD patient life Ø ~$250 million in recouped revenues per-week of reduced hospitalization 15
Slide 16: Ø ~280,000 U.S. ESRD patients Ø Average annual revenue per-patient is ~$62,000 Ø ~$1.45
Ø ~280,000 U.S. ESRD patients Ø Average annual revenue per-patient is ~$62,000 Ø ~$1.45 Billion in increased revenue per-month of extended ESRD patient life Ø ~$362 million in recouped revenues per-week of reduced hospitalization 16
Slide 17: Clinical Plan
Clinical Plan Ø Investigation Device Exemption (IDE) drafted for FDA submission Ø Feasibility study protocol to enroll 12-15 ESRD subjects at three site locations Ø Sigyn Therapy to be administered in series with regular dialysis treatments Ø Primary endpoint is safety / Secondary endpoints - change
Slide 18: Modular Feasibility Study Provides Potential Pathway into Market Enabling Studies
Modular Feasibility Study Provides Potential Pathway into Market Enabling Studies ESRD Endotoxemia & Inflammation Post Feasibility Study Clinical Opportunities Multiple Commercialization Humanitarian-Use ~$250M – The Market Cap Opportunities to Treat Rare Device Sepsis of a Company Advancing an Dise
Slide 19: Oncology
Oncology ”We don’t develop drugs to treat cancer. We develop devices to improve the benefit of drugs to treat cancer” 19
Slide 20: ChemoPrep Joint Venture Initiative
Joint Venture Initiatives to Optimize the Benefit of Cancer Therapies ChemoPrepTM Ø ChemoPrepTM is designed to improve delivery and reduce toxicity of chemotherapy, the most widely administered drug to treat cancer (<1% of chemotherapy doses are delivered to intended cancer targets) Ø ChemoPrepTM is
Slide 21: ImmunePrep Joint Venture Initiative
Joint Venture Initiatives to Optimize the Benefit of Cancer Therapies ImmunePrepTM Ø ImmunePrepTM is a platform technology to improve the delivery of immunotherapeutic antibodies, the top selling class of cancer drugs with revenues of ~$125 billion in 2024 (<1% of immunotherapeutic antibody doses ar
Slide 22: Public Market Data
Public Market Data Ø OTCQB: SIGY Ø Recent Price: $2.75 Ø 52-Week Range: $2.49 - $5.75 Ø Shares Outstanding: 1,605,377 Ø >90% of Shares Outstanding held by management, two funds, and one angel investment group ° 22
Slide 23: Next-Generation Blood Purification Therapies
Next-Generation Blood Purification Therapies 23
Slide 24: Focus is the Creation of Value Through Clinical Progression
Focus is the Creation of Value Through Clinical Progression Ø Sigyn TherapyTM addresses life-threatening inflammatory disorders - including sepsis, the #1 cause of hospital deaths - $62 billion annual cost to U.S. Healthcare system Joint Venture Initiatives to Optimize the Benefit of Cancer Therapie
Slide 25: SigynTherapeutics.com
2468 Historic Decatur Road, Suite 140 San Diego, California 92106 SigynTherapeutics.com 25
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