During the quarter, the Company continued its plan to initiate first-in-human studies of Sigyn TherapyTM and further advanced its endeavors to develop pipeline technologies to enhance the performance of cancer therapies. The initial treatment indication of Sigyn TherapyTM is being directed toward end-stage renal disease (ESRD) patients with endotoxemia, a condition that is highly prevalent and associated with increased mortality in the ESRD population. The Company has identified three clinical site locations and is working with principal investigators to finalize the study protocol. Once finalized, the Company intends to submit an Investigational Device Exemption (IDE) to The U.S. Food and Drug Administration (FDA) requesting permission to enroll up to 15 ESRD subjects with the primary objective to demonstrate the safety of Sigyn TherapyTM.
Summary of Third Quarter 2023 Financial Results
For the quarter ended September 30, 2023, the Company had a loss from operations of approximately $642,814, compared to an operating loss of approximately $533,647 for the comparable period of 2022. The Company’s net loss for the 2023 third quarter was approximately $905,726 or approximately $0.02 per share, compared to a net loss of approximately $726,509, or approximately $0.02 per share, for the comparable period in 2022.
About Sigyn Therapeutics™
Sigyn Therapeutics is a development-stage medical technology company headquartered in San Diego, California. Sigyn TherapyTM is a blood purification technology being advanced to treat a broad-spectrum of pathogen-induced disorders. The company plans to initiate first-in-human studies of Sigyn TherapyTM in end-stage renal disease patients with endotoxemia and concurrent inflammation. Other candidate treatment indications include community-acquired pneumonia, drug-resistant viral and bacterial infections, and sepsis, the leading cause of hospital deaths in the United States.
Sigyn Therapeutics is also developing therapeutic technologies to enhance and extend the performance of cancer therapies. ImmunePrepTM is a novel commercialization platform to improve the delivery of monoclonal antibodies (including cancer checkpoint inhibitors) and antibody drug-conjugates (ADCs). The Company’s pipeline also includes ChemoPrepTM to improve the tumor-site delivery of chemotherapeutic agents and ChemoPureTM to extract off-target chemotherapy from the bloodstream to reduce treatment toxicity.
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, 2022, 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.