Sigyn Therapeutics, Inc. Files 2023 Annual Report on Form 10-K

TL;DR

<b>Sigyn Therapeutics, Inc. has filed its 2023 annual report (10-K), detailing financial performance and corporate history.</b>

AI Summary

Sigyn Therapeutics, Inc. (SIGY) filed a Annual Report (10-K) with the SEC on February 20, 2024. Sigyn Therapeutics, Inc. filed its annual report on Form 10-K for the fiscal year ended December 31, 2023. The company was formerly known as Reign Resources Corp and Reign Sapphire Corp. The filing includes financial data for the fiscal years ended December 31, 2023, 2022, and 2021. Key dates mentioned include October 19, 2020, related to a Share Exchange Agreement. A subsequent event was noted on February 16, 2024.

Why It Matters

For investors and stakeholders tracking Sigyn Therapeutics, Inc., this filing contains several important signals. This filing provides a comprehensive overview of Sigyn Therapeutics' financial health and operational status for the fiscal year 2023, crucial for investors assessing the company's performance and future prospects. The inclusion of historical financial data and details on past name changes offers context for the company's evolution and strategic direction.

Risk Assessment

Risk Level: low — Sigyn Therapeutics, Inc. shows low risk based on this filing. The filing is a standard annual report (10-K) and does not contain immediate red flags or significant negative developments, indicating a low level of immediate risk based solely on this document.

Analyst Insight

Review the detailed financial statements and risk factors within the 10-K to understand Sigyn Therapeutics' current financial position and potential challenges.

Key Numbers

• 2023-12-31 — Fiscal Year End (Reporting period)
• 2024-02-20 — Filing Date (Date of submission)
• 000-55575 — SEC File Number (Company's SEC registration number)
• 3841 — SIC Code (Standard Industrial Classification for Surgical & Medical Instruments & Apparatus)

Key Players & Entities

• Sigyn Therapeutics, Inc. (company) — Filer name
• Reign Resources Corp (company) — Former company name
• Reign Sapphire Corp (company) — Former company name
• DE (location) — State of incorporation
• CA (location) — Business address state
• 2023-12-31 (date) — Fiscal year end
• 2024-02-20 (date) — Filing date
• 2020-10-19 (date) — Share Exchange Agreement date

FAQ

Key Dates

• 2023-12-31: Fiscal Year End — End of the reporting period for the annual financial statements.
• 2024-02-20: Filing Date — Date the 10-K was officially submitted to the SEC.
• 2020-10-19: Share Exchange Agreement — Significant corporate event related to the company's history.
• 2024-02-16: Subsequent Event — Indicates events that occurred after the balance sheet date but before the filing date.

Key Financial Figures

• $0.0001 — ction 12(g) of the Act: Common Stock, $0.0001 Par Value Indicate by check mark if t
• $3,429,516 — sult, the reported liabilities totaling $3,429,516 were converted into a total of 197,684

Filing Documents

• form10-k.htm (10-K) — 1852KB
• ex31-1.htm (EX-31.1) — 13KB
• ex31-2.htm (EX-31.2) — 12KB
• ex32-1.htm (EX-32.1) — 8KB
• ex32-2.htm (EX-32.2) — 8KB
• 0001493152-24-007240.txt (&nbsp;) — 8329KB
• sigyd-20231231.xsd (EX-101.SCH) — 43KB
• sigyd-20231231_cal.xml (EX-101.CAL) — 54KB
• sigyd-20231231_def.xml (EX-101.DEF) — 166KB
• sigyd-20231231_lab.xml (EX-101.LAB) — 330KB
• sigyd-20231231_pre.xml (EX-101.PRE) — 284KB
• form10-k_htm.xml (XML) — 1590KB

Business

Business 4 Item 1A.

Risk Factors

Risk Factors 17 Item 1B. Unresolved Staff Comments 17 Item 2.

Properties

Properties 17 Item 3.

Legal Proceedings

Legal Proceedings 17 Item 4. Mine Safety Disclosures 17 PART II Item 5. Market for the Registrant's Common Stock, Related Stockholder Matters and Issuer Repurchases of Equity Securities 18 Item 6.

Selected Financial Data

Selected Financial Data 18 Item 7.

Management's Discussion and Analysis of Financial Condition and Results of Operations

Management's Discussion and Analysis of Financial Condition and Results of Operations 18 Item 7A.

Quantitative and Qualitative Disclosures About Market Risk

Quantitative and Qualitative Disclosures About Market Risk 31 Item 8.

Financial Statements and Supplementary Data

Financial Statements and Supplementary Data 31 Item 9. Changes in and Disagreements with Accountants on Accounting and Financial Disclosure 31 Item 9A

Controls and Procedures

Controls and Procedures 31 Item 9B Other Information 33 PART III Item 10. Directors, Executive Officers and Corporate Governance 33 Item 11.

Executive Compensation

Executive Compensation 39 Item 12.

Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters

Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters 41 Item 13. Certain Relationships and Related Transactions, and Director Independence 43 Item 14. Principal Accounting Fees and Services 44 PART IV Item 15. Exhibits, Financial Statement Schedules 44 2 DISCLOSURE REGARDING FORWARD LOOKING STATEMENTS This report contains forward-looking statements. The forward-looking statements are contained principally in the sections entitled "Description of Business," "Risk Factors," and "Management's Discussion and Analysis of Financial Condition and Results of Operations." These statements involve known and unknown risks, uncertainties and other factors which may cause our actual results, performance or achievements to be materially different from any future results, performances or achievements expressed or implied by the forward-looking statements. In some cases, you can identify forward-looking statements by terms such as "anticipates," "believes," "seeks," "could," "estimates," "expects," "intends," "may," "plans," "potential," "predicts," "projects," "should," "would" and similar expressions intended to identify forward-looking statements. Forward-looking statements reflect our current views with respect to future events and are based on assumptions and subject to risks and uncertainties. These risks and uncertainties include, but are not limited to, the factors described in the section captioned "Risk Factors" below. Given these uncertainties, you should not place undue reliance on these forward-looking statements. Such statements may include, but are not limited to, information related to: anticipated operating results; licensing arrangements; relationships with our customers; consumer demand; financial resources and condition; changes in revenues; changes in profitability; changes in accounting treatment; cost of sales; selling, general and administrative expenses; interest expense; the ability to secur

Business

Business Overview Sigyn Therapeutics, Inc. ("Sigyn", the "Company" "we," "us," or "our") is a development-stage company that creates blood purification technologies to overcome clearly defined limitations in healthcare. Sigyn Therapy, our lead product candidate, is being advanced to treat life-threatening conditions that are not addressed with market-cleared drug agents. Candidate treatment indications include endotoxemia, sepsis (a leading cause of hospital deaths), community acquired pneumonia (a leading cause of infectious disease deaths), drug-resistant bacterial infections, and emerging pandemic viral threats. We plan to initiate first-in-human feasibility studies of Sigyn Therapy TM in End-Stage Renal Disease ("ESRD") patients with endotoxemia and concurrent inflammation, whose incidence is elevated among ~550,000 U.S. dialysis patients. To support the initiation of our proposed study, we have drafted an Investigational Device Exemption ("IDE") for submission to the U.S. Food and Drug Administration ("FDA"). Our clinical study plan proposes to enroll 12-15 ESRD subjects to evaluate the safety of Sigyn Therapy at three clinical site locations that have already been identified and evaluated by a contract research organization that specializes in ESRD related clinical studies. Beyond our clinical objective to demonstrate safety, we will also quantify changes in endotoxin levels as well as markers of inflammation as secondary endpoints. However, the clinical plan proposed in our IDE has not yet been communicated to FDA and there is no assurance that FDA will approve the initiation of our proposed feasibility study. Additionally, there is no assurance that we will receive FDA market approval of Sigyn Therapy TM as a Class III medical device. Our Therapeutic Pipeline Our therapeutic pipeline is comprised of technologies that we have designed to improve the targeted delivery of cancer drug agents. ChemoPrep TM and ChemoPure TM are components of a therapeuti

View Full Filing

View this 10-K filing on SEC EDGAR