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Sigyn Therapeutics, Inc. (OTCQB: SIGY) is a development-stage medical technology company based in San Diego, California. The company is pioneering blood purification technologies to address pathogen-associated inflammatory disorders, which are not effectively treated by traditional drug therapies.
Sigyn's flagship product, Sigyn Therapy™, targets a range of severe medical conditions including endotoxemia, sepsis, community-acquired pneumonia, and infections by drug-resistant bacteria and viruses. The initial clinical focus is on end-stage renal disease (ESRD) patients suffering from endotoxemia, a prevalent condition linked to increased mortality.
Further broadening its innovative portfolio, Sigyn Therapeutics is also developing ImmunePrep™, ChemoPrep™, and ChemoPure™. ImmunePrep™ aims to improve the efficacy of immunotherapeutic antibodies, a market projected to grow exponentially. ChemoPrep™ is designed to enhance the delivery and reduce the toxicity of chemotherapy, addressing a crucial need as less than 5% of chemotherapy reaches the tumor site. ChemoPure™ further mitigates chemotherapy toxicity by extracting off-target drugs from the bloodstream post-treatment.
Despite its development-stage status, Sigyn has demonstrated promising in vitro results, reducing the prevalence of multiple pathogen and inflammatory targets in human blood plasma. The company has initiated steps to begin first-in-human studies and is in the process of finalizing study protocols for Sigyn Therapy™ in ESRD patients.
On the financial front, Sigyn reported a net loss of approximately $4.1 million for the year ending December 31, 2023, indicating its commitment to research and development. The company recently completed a 1-for-40 reverse stock split, a strategic move aimed at meeting Nasdaq listing requirements.
Sigyn Therapeutics continues to advance its mission, positioning itself as a leader in the medical technology field with a comprehensive pipeline aimed at improving patient outcomes and addressing unmet medical needs.
Sigyn Therapeutics announces the appointment of Annette Marleau, Ph.D. as Chief Scientific Officer, effective immediately. Dr. Marleau, an expert in blood purification technologies, previously served as Chief Technology Officer at Immunicom, leading R&D for cancer treatment candidates. She has significant achievements, including over $6 million in NIH funding and contributions to FDA-cleared Investigational Device Exemptions. Sigyn's lead product, Sigyn Therapy, is designed for pathogen-associated inflammatory disorders, targeting conditions like sepsis and pneumonia. The company's pipeline also includes ChemoPrep and ChemoPure, aimed at enhancing chemotherapy delivery and reducing toxicity. This leadership change could strengthen Sigyn's position in the competitive biotechnology market.
Sigyn Therapeutics, Inc. (OTCQB: SIGY) announced the filing of its Form 10-K annual report for the year ending December 31, 2022. The Company reported a net loss of approximately $2.9 million, consistent with the previous year's loss. In 2022, Sigyn advanced its Sigyn Therapy™ towards clinical studies, targeting pathogen-associated inflammatory disorders like sepsis and renal disease, and expanded its intellectual property and corporate team. Additionally, a cancer treatment system to enhance chemotherapy delivery was initiated. The Company utilized approximately $1.8 million in net cash for operating activities during the year.
Sigyn Therapeutics (OTCQB: SIGY) reported its third quarter results for 2022, showing a net loss of approximately $727,000 ($0.02 per share), slightly higher than the prior year's loss of $666,000. The company has advanced its operations by commencing trading on the OTCQB Venture Exchange and strengthening its Board of Directors. It is also pursuing first-in-human studies for Sigyn Therapy in End-Stage Renal Disease patients. Key developments include a provisional patent application for a cancer treatment system designed to enhance chemotherapy delivery and reduce toxicity.
Sigyn Therapeutics (OTCQB: SIGY) announced the filing of trademark applications for ChemoPrep and ChemoPure with the USPTO, linked to a patent for enhancing chemotherapy delivery while reducing toxicity. The new system aims to improve tumor site delivery and minimize side effects of chemotherapeutic agents, addressing significant challenges in cancer treatment. Sigyn's technology may also inhibit cancer metastasis related to chemotherapy. The company continues to develop its pipeline, including Sigyn Therapy, targeting unmet health needs.
Sigyn Therapeutics (OTCQB: SIGY) has filed a provisional patent application for a system to enhance chemotherapy delivery and reduce associated toxicity. Currently, less than 5% of chemotherapeutic agents effectively reach tumor sites, leading to toxic side effects and drug resistance. The proposed system aims to improve drug delivery while potentially reducing treatment dosages. CEO Jim Joyce emphasized that this innovation is designed to enhance existing FDA-approved drugs. The company is also advancing its Sigyn Therapy for patients with end-stage renal disease and other serious conditions.
Sigyn Therapeutics (OTCQB: SIGY) has appointed Richa Nand, Jim Dorst, and Christopher Wetzel to its Board of Directors, effective October 10, 2022. This move aims to enhance the company's leadership as it progresses in its clinical development. Nand brings over 20 years of experience in intellectual property law, Dorst has a robust background in finance and operations, while Wetzel holds extensive leadership experience in healthcare delivery. These appointments are expected to bolster Sigyn's strategy in advancing its Sigyn Therapy, which targets pathogen-associated inflammatory disorders.
Sigyn Therapeutics (OTCQB: SIGY) plans to pursue first-in-human feasibility studies of Sigyn Therapy for End-Stage Renal Disease (ESRD) patients experiencing inflammation and endotoxemia. As more than 550,000 individuals in the U.S. suffer from ESRD, and no approved drugs exist for related inflammation, this therapy aims to improve patient outcomes. The therapy combines with regular dialysis to target inflammation by extracting pathogens and cytokines from the bloodstream. The company is updating an Investigational Device Exemption for FDA submission, though success is not guaranteed.
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