San Diego, CA - (NewMediaWire) - 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, today announces its financial results for the second quarter ended June 30, 2022 and provides an update on recent corporate developments.

“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.

About Sigyn Therapeutics™

Sigyn Therapeutics is a development-stage company focused on the creation of therapeutic solutions that address unmet needs in global health.  

Sigyn Therapy™ is a broad-spectrum blood purification device that addresses life-threatening infections and inflammatory disorders for which effective drug therapies are not available.  Sigyn Therapy extracts pathogen sources of life-threatening inflammation in concert with dampening down the dysregulated overproduction of inflammatory cytokines (the cytokine storm), which play a prominent role in each of our candidate treatment indications. 

Based on Sigyn Therapy’s ability to isolate and extract viral pathogens, bacterial toxins, and inflammatory cytokines from the bloodstream, our candidate treatment opportunities include 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.

To learn more about our therapeutic endeavors, market opportunities and management team, we encourage you to visit our website at: www.SigynTherapeutics.com

Cautionary Note Regarding Forward-Looking Statements

This information in this press release contains forward-looking statements of Sigyn Therapeutics, Inc. (“Sigyn”) that involve substantial risks and uncertainties. All statements contained in this summary are forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934 that involve risks and uncertainties.  Statements containing words such as "may," "believe," "anticipate," "expect," "intend," "plan," "project," "will," "projections," "estimate," "potentially" or similar expressions constitute forward-looking statements. Such forward-looking statements are subject to significant risks and uncertainties and actual results may differ materially from the results anticipated in the forward-looking statements. These forward-looking statements are based upon Sigyn's current expectations and involve assumptions that may never materialize or may prove to be incorrect. Factors that may contribute to such differences may include, without limitation, the Company's ability to clinically advance Sigyn Therapy in human studies required for market clearance, the Company's ability to manufacture Sigyn Therapy, the Company's ability to raise capital resources, and other potential risks. The foregoing list of risks and uncertainties is illustrative but is not exhaustive. Additional factors that could cause results to differ materially from those anticipated in forward-looking statements can be found under the caption "Risk Factors" in the Company's Annual Report on Form 10-K for the year ended December 31, 2021, and in the Company's other filings with the Securities and Exchange Commission, including its quarterly Reports on Form 10-Q. All forward-looking statements contained in this report speak only as of the date on which they were made. Except as may be required by law, the Company does not intend, nor does it undertake any duty, to update this information to reflect future events or circumstances.

Contacts:

Stephen Kilmer

Sigyn Therapeutics, Inc.

Investor Relations

(646) 274-3580

stephen@sigyntherapeutics.com

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