NOTE 1 – ORGANIZATION AND PRINCIPAL ACTIVITIES

Corporate History and Background

Sigyn Therapeutics, Inc. (“Sigyn”, the “Company” “we,” “us,” or “our”) is a development-stage Company advancing dialysis-like therapies to address cardiovascular disease and cancer. Sigyn CardioDialysis™ (previously known as Sigyn Therapy^TM) is a novel blood purification technology to treat cardiovascular disease, the leading cause of death globally. CardioDialysis™ aims to reduce the circulating presence of inflammatory molecules that fuel cardiovascular disease progression while simultaneously lowing levels of cholesterol-transporting lipoproteins that contribute to heart attacks, strokes, and other Major Adverse Cardiovascular Events (MACE).

Based on its broad-spectrum mechanism, CardioDialysis™ offers to reduce the incidence of MACE by overcoming the inherent limitations of single-target drugs.

Our development pipeline of cancer therapies is comprised of ImmunePrep™ to optimize the delivery of immunotherapeutic antibodies; ChemoPrep™ to enhance the targeted delivery of chemotherapy; and ChemoPure™ to reduce the toxicity of chemotherapy.

Recent Event

On November 6, 2025, we disclosed in a letter to shareholders the filing of a trademark application with the United States Patent and Trademark Office to protect the name CardioDialysis^TM. The action reflects our intent to shift the previous therapeutic focus of Sigyn Therapy^TM toward cardiovascular disease.

This action provides us a pathway into a larger market opportunity, for which there is an FDA-approved device precedent that clinically demonstrates the ability of blood purification to reduce Major Adverse Cardiovascular Disease Events (MACE). As compared to our previously proposed treatment indications, 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. Furthermore, we consider our potential value to the dialysis industry as a majority of their patients die from cardiovascular disease related events. Our previously proposed indications, which included the treatment of sepsis, drug-resistant bacterial infections, and life-threatening viruses will become downstream therapeutics opportunities.

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”).