Sigyn Therapeutics™ Announces Filing of 2023 Annual Report on SEC Form 10-K

Rhea-AI Summary

Sigyn Therapeutics, Inc. filed its Form 10-K annual report with the SEC for 2023, introduced new therapeutic candidates, and prepared for first-in-human clinical studies. The company reported a loss from operations of $2.5 million and a net loss of $4.1 million for 2023.

SAN DIEGO, CA, Feb. 21, 2024 (GLOBE NEWSWIRE) -- via NewMediaWire – Sigyn Therapeutics, Inc. (“Sigyn Therapeutics” or the “Company”) (OTCQB: “SIGYD” – “SIGY”), a development-stage medical technology company, announced today the filing of its Form 10-K annual report with the United States Securities and Exchange Commission ("SEC") for the year-ended December 31, 2023. 

The annual report can be accessed on the SEC's website at www.sec.gov or on the Company's website at www.sigyntherapeutics.com under the "investors" section.

Post Year-End 2023 Event

On January 31, 2024, the Company completed a 1-for-40 reverse split of its common stock.  As a result, the Company’s common shares currently trade under the symbol “SIGYD” and will revert back to the trading symbol “SIGY” on February 29, 2024.  At present, the Company reports 1,224,315 shares of its common stock to be issued and outstanding.

Summary of 2023 Events

During 2023, Sigyn Therapeutics expanded its line-up of therapeutic candidates to enhance the performance of cancer therapies through the introduction of ImmunePrep^TM, a platform technology to improve the delivery of immunotherapeutic antibodies, which account for nine of the top 15 best-selling cancer treatment drugs.

Additionally, the Company is developing ChemoPrep^TM, a medical technology to optimize the delivery of chemotherapy, the most commonly administered drug to treat cancer, and ChemoPure^TM to extract off-target chemotherapy from the bloodstream to reduce treatment toxicity.

During the course of 2023, the Company also established the treatment protocol and identified clinical site locations for first-in-human clinical studies of Sigyn Therapy^TM, a novel blood purification technology to address pathogen-associated conditions that are not treatable with drug therapies. Candidate treatment indications include drug resistant viral and bacterial infections, endotoxemia, and sepsis.

The first-in-human treatment protocol calls for the enrollment of dialysis dependent end-stage renal disease (ESRD) patients with endotoxemia and concurrent inflammation. These are untreatable conditions associated with cardiovascular disease, a leading cause of ESRD patient deaths.  Endotoxemia and inflammation also underly other common causes of ESRD mortality, including viral and bacterial infections that induce sepsis. To support the proposed study, the Company has drafted an Investigational Device Exemption (IDE) for submission to the United States Food and Drug Administration (FDA).  At present, more than 550,000 individuals suffer from ESRD in the United States.

Summary of 2023 Financial Results

For the year ended December 31, 2023, the Company had a loss from operations of approximately $2.5 million, compared to an operating loss of approximately $2.1 for the comparable period of 2022. The Company’s net loss for the year ended December 31, 2023, was approximately $4.1 million, or $3.77 per share, compared to a net loss of approximately $2.9 million, or $3.13 per share for the comparable period in 2022. In 2023, net cash used in operating activities was approximately $1.4 million, as compared to approximately $1.8 million in 2022.

About Sigyn Therapeutics™

Sigyn Therapeutics is a development-stage medical technology company headquartered in San Diego, California. The Company’s therapeutic candidates are each designed to overcome a clearly defined limitation in healthcare. These include the ImmunePrep^TM platform, ChemoPrep^TM, ChemoPure^TM, and Sigyn Therapy^TM.

ImmunePrep^TM is a development-stage commercialization platform to enhance and extend the performance of immunotherapeutic antibodies, which account for nine of the top 15 best-selling cancer treatment drugs. ChemoPrep^TM is designed to optimize the delivery of chemotherapy, the most commonly administered drug to treat cancer, while ChemoPure^TM extracts off-target chemotherapy from the bloodstream to reduce patient toxicity.

Sigyn Therapy^TM is a novel blood purification technology being advanced to treat pathogen-associated conditions that are not addressed with drug therapies.  In vitro studies have demonstrated the ability of Sigyn Therapy^TM to reduce the circulating prevalence of twelve pathogen and inflammatory disease targets from human blood plasma.  Based on these outcomes, candidate treatment indications include drug resistant viral and bacterial infections, endotoxemia, and sepsis, the leading cause of hospital deaths in the United States.  First-in-human feasibility studies of Sigyn Therapy^TM plan to enroll end-stage renal disease (ESRD) patients with endotoxemia and concurrent inflammation, which are highly prevalent and associated with increased mortality in the ESRD population.

To learn more about Sigyn Therapeutics, visit: 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, 2023, 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.

Contact:

Jim Joyce
Chairman, CEO
Phone: 619.353.0800
Email: jj@SigynTherapeutics.com

FAQ

What did Sigyn Therapeutics announce in the press release?

Sigyn Therapeutics announced the filing of its Form 10-K annual report with the SEC for the year-ended December 31, 2023, and completion of a 1-for-40 reverse stock split.

What new technologies did Sigyn Therapeutics introduce in 2023?

In 2023, Sigyn Therapeutics introduced ImmunePrepTM to enhance cancer therapies, ChemoPrepTM to optimize chemotherapy delivery, and ChemoPureTM to reduce treatment toxicity.

What is Sigyn TherapyTM?

Sigyn TherapyTM is a novel blood purification technology developed by Sigyn Therapeutics to address pathogen-associated conditions such as drug-resistant viral and bacterial infections, endotoxemia, and sepsis.

What financial results did Sigyn Therapeutics report for 2023?

Sigyn Therapeutics reported a loss from operations of $2.5 million, a net loss of $4.1 million, and net cash used in operating activities of approximately $1.4 million for the year ended December 31, 2023.