NOTE 1 – ORGANIZATION AND PRINCIPAL ACTIVITIES

Corporate History and Background

Sigyn Therapeutics, Inc. (“Sigyn”, the “Company” “we,” “us,” or “our”) develops medical devices to treat cancer and infectious disease disorders. We believe our lineup of therapeutic candidates is among the most expansive in the field of extracorporeal blood purification. To optimize the benefit of drugs to treat cancer, we invented the ImmunePrep^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, which if successful, will address infectious disease disorders that are not treatable with drugs. If successfully advanced, our therapies may provide strategic value to the pharmaceutical, dialysis, and organ transplant industries.

Infectious Disease Disorders

To address infectious disease disorders that are not treatable with drugs, we designed Sigyn Therapy^TM to extract deadly pathogens and toxins from a patient’s bloodstream, while simultaneously providing a mechanism to dampen down excessive immune responses that are associated with life-threatening infections. Sigyn Therapy^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:

Previous Infectious Disease Industry Achievements

The Company’s management has relevant experience in developing blood purification technologies to treat infectious disease disorders. Most members of our team previously worked alongside our CEO while overseeing development of the first medical device to receive FDA “Emergency Use Authorization” approval to treat an infectious viral pathogen (Ebola) and the first to receive two “Breakthrough Device” designation awards from FDA. As a result of these achievements, in 2015, TIME Magazine named the device to its list of “Top Inventions” and “Top Medical Breakthroughs.”

Sigyn Therapy^TM Human Studies

First-in-human clinical studies of Sigyn Therapy^TM plan to enroll end-stage renal disease (ESRD) subjects with endotoxemia and concurrent inflammation, which are prevalent, yet untreatable conditions that shorten the lives of dialysis patients. Approximately 550,000 individuals suffer from ESRD in the United States. A therapeutic strategy that helps to extend the lives of ESRD patients may have quantifiable value to the dialysis industry, which is dominated by Fresenius Medical Care and DaVita, Inc. in North America. Based on the number of ESRD patients treated in their networks, every month of extended life would equate to approximately $1 billion in added revenues for each company.

Emerging Opportunity in Xenotransplantation

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

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

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.

To learn more, visit: www.SigynTherapeutics.com.

Merger Transaction

On October 19, 2020, Sigyn Therapeutics, Inc, a Delaware corporation (the “Registrant”) formerly known as Reign Resources Corporation, completed a Share Exchange Agreement (the “Agreement”) with Sigyn Therapeutics, Inc., a private entity incorporated in the State of Delaware on October 19, 2019.

In the Share Exchange Agreement, we acquired 100% of the issued and outstanding shares of privately held Sigyn Therapeutics common stock in exchange for 75% of the fully paid and nonassessable shares of our common stock outstanding (the “Acquisition”). In conjunction with the transaction, we changed our name from Reign Resources Corporation to Sigyn Therapeutics, Inc. pursuant to an amendment to our articles of incorporation that was filed with the State of Delaware. Subsequently, our trading symbol was changed to SIGY. The Acquisition was treated by the Company as a reverse merger in accordance with accounting principles generally accepted in the United States of America (“GAAP”).

Reverse Stock Split

Effective January 19, 2024, 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.