On August 15, 2022 Sigyn Therapeutics, Inc. (OTCQB: SIGY), a development-stage company focused on the creation of therapeutic solutions that address unmet needs in global health, reported its financial results for the second quarter ended June 30, 2022 and provides an update on recent corporate developments (Press release, Sigyn Therapeutics, AUG 15, 2022, View Source [SID1234618341]).
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"We continue to take meaningful steps toward our goal to advance Sigyn Therapy into human clinical studies," commented Jim Joyce, co-founder and CEO of Sigyn Therapeutics. "Of particular note was our successful completion of in vivo animal studies, which followed a series of in vitro studies that demonstrated the ability of Sigyn Therapy to isolate and extract pathogen sources of life-threatening inflammation in concert with the broad-spectrum depletion of proinflammatory cytokines from human blood plasma. The data from these studies is being incorporated into an Investigational Device Exemption that we are drafting for submission to the U.S. Food and Drug Administration to support potential human studies of Sigyn Therapy in the United States."
Sigyn Therapy is multi-function blood purification technology designed to treat life-threatening infections and inflammatory disorders that are not addressed with approved drugs. In vitro study validations of pathogen sources of life-threatening inflammation include endotoxin (a gram-negative bacterial toxin), peptidoglycan and lipoteichoic acid (gram-positive bacterial toxins), and viral pathogens, including COVID-19. In vitro study validations of inflammatory cytokines include interleukin-1 beta (IL-1b), interleukin-6 (IL-6), and tumor necrosis factor alpha (TNF-a).
Based on these capabilities, the Company believes that Sigyn Therapy is a candidate to treat pathogen-associated sepsis (leading cause of hospital deaths), community acquired pneumonia (a leading cause of death among infectious diseases), emerging pandemic threats, and hyperinflammation & endotoxemia that commonly occurs in end-stage renal disease patients.
Recent 2022 Developments
Reported the successful completion of in vivo animal studies conducted at the University of Michigan.
Appointed accomplished financial executive, Jeremy Ferrell, CPA, MBA as Chief Financial Officer.
Established a Scientific Advisory Board comprised of recognized clinician researchers and thought leaders from the fields of nephrology, neurology, hepatology, and liver transplantation.
On August 3, 2022, announced that its securities had graduated from trading on the OTC Pink Market to the OTCQB Venture Exchange, and confirmed the Company continues to pursue the listing of its securities on a major exchange.
Summary Second Quarter 2022 Financial Results
For the quarter ended June 30, 2022, the Company had a loss from operations of approximately $533,000, compared to an operating loss of approximately $442,000 for the comparable period of 2021. The Company’s net loss for the 2022 second quarter was approximately $666,000, or approximately $0.02 per share, compared to a net loss of approximately $650,000, or approximately $0.02 per share, for the comparable period in 2021. Second quarter 2022 net cash used in operating activities was approximately $395,000.
For complete financial results, please see Sigyn Therapeutics’ filings at www.sec.gov, and on the Company’s website at www.SigynTherapeutics.com under "Financial Info" in the Investors section.