UEEC 10-Q
United Health Products, Inc. (UEEC)
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM
QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 |
For the quarterly period ended
TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 |
For the transition period from ____________ to ____________
Commission file number:
(Exact name of Company as specified in its charter) |
| ||
(State or other jurisdiction of incorporation or organization) |
| (I.R.S. Employer Identification No.) |
| ||
(Address of Company’s principal executive offices) |
| (Zip Code) |
(
(Company’s telephone number, including area code)
None
(Former name, former address and former fiscal year, if changed since last report)
Securities registered pursuant to Section 12 (b) of the Act: None
Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports) and (2) has been subject to such filing requirements for the past 90 days.
Indicate by checkmark whether the registrant has submitted electronically every Interactive Data File required to be submitted pursuant to Rule 405 of Regulation S-T during the 12 preceding months (or such shorter period that the registrant was required to submit such file).
Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, smaller reporting company, or an emerging growth company. See definition of “large accelerated filer,” “accelerated filer,” “smaller reporting company,” and “emerging growth company” in Rule 12b-2 of the Exchange Act.
Large accelerated filer | ☐ | Accelerated filer | ☐ |
☒ | Smaller reporting company | ||
| Emerging growth company |
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐
Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act). Yes
The number of shares issued and outstanding of the Registrant’s Common Stock, as of November 12, 2024 was
UNITED HEALTH PRODUCTS, INC.
FORM 10-Q QUARTERLY REPORT
TABLE OF CONTENTS
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PART I. FINANCIAL INFORMATION | ||||
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Item 1. | Financial Statements (Unaudited) | 3 | ||
| Condensed Balance Sheets as of September 30, 2024 (unaudited) and December 31, 2023 | 3 | ||
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Management’s Discussion and Analysis of Financial Condition and Results of Operations | 17 | |||
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| 2 |
| Table of Contents |
UNITED HEALTH PRODUCTS, INC.
Condensed Balance Sheets
|
| September 30, |
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| December 31, |
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| 2024 |
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| 2023 |
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| (Unaudited) |
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ASSETS |
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Current Assets |
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Cash and cash equivalents |
| $ |
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Inventory |
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Prepaid and other current assets |
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Total current assets |
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Deferred offering costs |
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Operating lease right-of-use asset |
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Security deposit |
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Patents, net |
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TOTAL ASSETS |
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Current Liabilities |
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Accounts payable and accrued expenses |
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Accrued liabilities - related parties |
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Operating lease liability - current |
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Notes payable |
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Convertible notes payable, net of debt discount |
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Convertible notes payable – related party, net of debt discount |
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Total current liabilities |
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Operating lease liability – long-term |
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TOTAL LIABILITIES |
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Commitments and Contingencies |
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Stockholders’ Deficit |
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Series A Convertible Preferred Stock - $ |
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Common Stock - $ |
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Additional Paid-In Capital |
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Accumulated Deficit |
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Total Stockholders’ Deficit |
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TOTAL LIABILITIES AND STOCKHOLDERS’ DEFICIT |
| $ |
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| $ |
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See notes to unaudited condensed financial statements.
| 3 |
| Table of Contents |
UNITED HEALTH PRODUCTS, INC.
Condensed Statements of Operations
(Unaudited)
|
| For the Three Months Ended September 30, |
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| For the Nine Months Ended September 30, |
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| 2024 |
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| 2023 |
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| 2023 |
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Revenues |
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Operating Costs and Expenses |
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Selling, general and administrative expenses |
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Research and development |
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Total Operating Expenses |
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Loss from Operations |
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Other Income (Expenses) |
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Interest expense |
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Interest expense – related party |
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Gain (loss) on settlement of debt |
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Total Other Income (Expenses) |
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Net Income (Loss) |
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| $ | ( | ) |
| $ | ( | ) |
| $ | ( | ) |
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Net Income (Loss) per common share: |
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Basic and diluted |
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| $ | ( | ) |
| $ | ( | ) |
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Weighted average number of shares outstanding |
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See notes to unaudited condensed financial statements.
| 4 |
| Table of Contents |
UNITED HEALTH PRODUCTS, INC
Condensed Statement of Stockholders’ Deficiency
Three and Nine Months Ended September 30, 2024 and September 30, 2023
(Unaudited)
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| Additional |
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| Common Stock |
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| Paid-in |
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| Subscription |
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| Accumulated |
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| Shares |
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| Amount |
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| Capital |
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| Receivable |
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| Deficit |
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| Total |
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Balance at December 31, 2022 |
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| $ |
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| $ |
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| $ | ( | ) |
| $ | ( | ) |
| $ | ( | ) | |||
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Sale of common stock |
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Common stock issued to settle accrued liabilities – related party |
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Common stock issued to settle accrued liabilities |
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Common stock issued for a stock subscription receivable |
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Amortization of deferred offering costs |
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| - |
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Common stock issued for litigation settlement |
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Net Loss |
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| - |
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Balance at March 31, 2023 |
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Sale of common stock |
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Common stock issued to settle accrued liabilities – related party |
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Common stock issued to settle accrued liabilities |
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Common stock issued for a stock subscription receivable |
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Amortization of deferred offering costs |
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| - |
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Net Loss |
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| - |
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Balance at June 30, 2023 |
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Sale of common stock |
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Amortization of deferred offering costs |
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| - |
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Net loss |
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| - |
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Balance at September 30, 2023 |
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| $ |
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| $ |
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| $ |
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| $ | ( | ) |
| $ | ( | ) | ||||
| 5 |
| Table of Contents |
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| Additional |
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| Common Stock |
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| Paid-in |
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| Accumulated |
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| Shares |
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| Amount |
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| Capital |
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| Deficit |
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| Total |
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Balance at December 31, 2023 |
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| $ |
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| $ | ( | ) |
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Sale of common stock |
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Amortization of deferred offering costs |
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| - |
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Net Loss |
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| - |
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Balance at March 31, 2024 |
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Sale of common stock |
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Net Loss |
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| - |
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Balance at June 30, 2024 |
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Sale of common stock |
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Net Loss |
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| - |
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Balance at September 30, 2024 |
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| $ |
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| $ |
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| $ | ( | ) |
| $ | ( | ) | |||
See notes to unaudited condensed financial statements.
| 6 |
| Table of Contents |
UNITED HEALTH PRODUCTS, INC.
Condensed Statements of Cash Flows
(Unaudited)
|
| For the Nine Months Ended September 30, |
| |||||
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| 2024 |
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| 2023 |
| ||
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Cash Flows from Operating Activities: |
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Net (Loss) |
| $ | ( | ) |
| $ | ( | ) |
Adjustments to Reconcile Net (Loss) to Net Cash Used In Operating Activities: |
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Write-off of inventory |
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Amortization of debt discount |
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Amortization expense |
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Amortization of right-of-use asset |
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Stock issued for litigation settlement |
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(Gain) loss on settlement of debt |
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| ( | ) |
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Changes in assets and liabilities: |
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Inventory |
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Prepaid and other current assets |
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|
| ( | ) | |
Accounts payable and accrued expenses |
|
|
|
|
| ( | ) | |
Accrued liabilities – related party |
|
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| ||
Accrued litigation settlement |
|
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|
| ( | ) | |
Net Cash Used In Operating Activities |
|
| ( | ) |
|
| ( | ) |
|
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|
Cash Flows from Investing Activities: |
|
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|
Security deposit |
|
|
|
|
| ( | ) | |
Net Cash Used in Investing Activities |
|
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|
| ( | ) | |
|
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|
|
|
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|
Cash Flows from Financing Activities: |
|
|
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|
|
|
|
|
Repayments on loan payable - related party |
|
|
|
|
| ( | ) | |
Repayments on loan payable |
|
|
|
|
| ( | ) | |
Payment of offering costs |
|
| ( | ) |
|
| ( | ) |
Proceeds from sale of common stock |
|
|
|
|
|
| ||
Proceeds from note payable |
|
|
|
|
|
| ||
Cash flow provided by financing activities |
|
|
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| ||
Increase (decrease) in Cash and Cash Equivalents |
|
| ( | ) |
|
|
| |
Cash and Cash Equivalents – Beginning of period |
|
|
|
|
|
| ||
|
|
|
|
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|
|
|
|
CASH AND CASH EQUIVALENTS – END OF PERIOD |
| $ |
|
| $ |
| ||
|
|
|
|
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|
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|
Supplemental cash flow information: |
|
|
|
|
|
|
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|
Cash paid for interest |
| $ |
|
| $ |
| ||
Cash paid for income taxes |
| $ |
|
| $ |
| ||
|
|
|
|
|
|
|
|
|
Non-cash Investing & Financing Activities: |
|
|
|
|
|
|
|
|
Amortization of deferred offering costs |
| $ |
|
| $ |
| ||
Initial recognition of operating lease right-of-use asset and operating lease liability |
| $ |
|
| $ |
| ||
Common stock issued to settle accrued liabilities – related party |
| $ |
|
| $ |
| ||
Accounts payable and accrued expenses paid with promissory note payable |
| $ |
|
| $ |
| ||
Common stock issued to settle accounts payable and accrued liabilities |
| $ |
|
| $ |
| ||
See notes to unaudited condensed financial statements.
| 7 |
| Table of Contents |
UNITED HEALTH PRODUCTS, INC.
NOTES TO CONDENSED FINANCIAL STATEMENTS
FOR THE QUARTERS ENDED SEPTEMBER 30, 2024 AND 2023
(Unaudited)
Note 1. Organization and Basis of Preparation
United Health Products, Inc. (the “Company”) develops, manufactures, and markets a patented hemostatic gauze for the healthcare and wound care sectors. Our gauze product, CelluSTAT® (formerly branded as HemoStyp), is derived from cotton and designed to absorb exudate/drainage from superficial wounds and help control bleeding. We are in the process of seeking regulatory approval to sell our hemostatic gauze product line into the U.S. Class III and European CE Mark human surgical markets.
The accompanying unaudited condensed financial statements of the Company have been prepared in accordance with the rules and regulations of the Securities and Exchange Commission (the “SEC”), including the instructions to Form 10-Q and Regulation S-X. Certain information and note disclosures normally included in financial statements prepared in accordance with generally accepted accounting principles in the United States of America (“U.S. GAAP”), have been condensed or omitted from these statements pursuant to such rules and regulations and, accordingly, they do not include all the information and notes necessary for comprehensive financial statements and should be read in conjunction with our audited financial statements included in our Annual Report on Form 10-K for the year ended December 31, 2023 filed with the SEC on April 1, 2024.
In the opinion of management, all adjustments, which are of a normal recurring nature, considered necessary for the fair presentation of financial statements for the interim period, have been included.
Note 2. Significant Accounting Policies
Going Concern
The accompanying financial statements have been prepared assuming that the Company will continue as a going concern. The Company has incurred recurring net losses, negative working capital and operations have not provided cash flows. Additionally, the Company does not currently have sufficient revenue producing operations to cover its operating expenses and meet its current obligations. In view of these matters, there is substantial doubt about the Company’s ability to continue as a going concern. The Company intends to finance its future development activities and its working capital needs largely from the sale of equity securities with some additional funding from other traditional financing sources, including term notes, until such time that funds provided by operations are sufficient to fund working capital requirements. The financial statements of the Company do not include any adjustments relating to the recoverability and classification of recorded assets, or the amounts and classifications of liabilities that might be necessary should the Company be unable to continue as a going concern.
Cash and Cash Equivalents
The Company considers all highly liquid debt investments purchased with a maturity of three months or less to be cash equivalents.
| 8 |
| Table of Contents |
Use of Estimates
The preparation of financial statements in conformity with generally accepted accounting principles requires the Company’s management to make estimates and assumptions that affect the reported amounts of assets and liabilities at the date of the financial statements and the reported amounts of income and expenses during the reported period. Changes in the economic environment, financial markets, as well as in the healthcare industry, and any other parameters used in determining these estimates, could cause actual results to differ.
Fair Value Measurements
Accounting principles generally accepted in the United States define fair value as the exchange price that would be received for an asset or paid to transfer a liability (an exit price) in the principal or most advantageous market for the asset or liability in an orderly transaction between market participants at the measurement date. Additionally, the inputs used to measure fair value are prioritized based on a three-level hierarchy. This hierarchy requires entities to maximize the use of observable inputs and minimize the use of unobservable inputs. The three levels of inputs used to measure fair value are as follows:
Level 1 — Quoted prices in active markets for identical assets or liabilities.
Level 2 — Observable inputs other than quoted prices included in Level 1. We value assets and liabilities included in this level using dealer and broker quotations, bid prices, quoted prices for similar assets and liabilities in active markets, or other inputs that are observable or can be corroborated by observable market data.
Level 3 — Unobservable inputs that are supported by little or no market activity and that are significant to the fair value of the assets or liabilities. This includes certain pricing models, discounted cash flow methodologies and similar techniques that use significant unobservable inputs.
Fair value estimates discussed herein are based upon certain market assumptions and pertinent information available to management as of September 30, 2024 and December 31, 2023. The respective carrying value of certain on-balance-sheet financial instruments approximated their fair values due to the short-term nature of these instruments.
Revenue Recognition
The Company recognizes revenue in accordance with ASC 606, Revenue from Contracts with Customers. Under ASC 606, the Company recognizes revenue from the sale of its CelluSTAT product by applying the following steps: (1) identify the contract with a customer; (2) identify the performance obligations in the contract; (3) determine the transaction price; (4) allocate the transaction price to each performance obligation in the contract; and (5) recognize revenue when each performance obligation is satisfied.
The Company receives orders for its CelluSTAT products directly from its customers. Revenues are recognized based on the agreed upon sales or transaction price with the customer when control of the promised goods are transferred to the customer. The transfer of goods to the customer and satisfaction of the Company’s performance obligation will occur either at the time when products are shipped or when the products arrive and are received by the customer. No discounts are currently offered by the Company. The Company does not provide an estimate for returns as there is no anticipation for any returns in the normal course of business.
Trade Accounts Receivable and Concentration Risk
We record accounts receivable at the invoiced amount and we do not charge interest. We review the accounts receivable by amounts due from customers that are past due, to identify specific customers with known disputes or collectability issues. In determining the amount of the reserve, we make judgments about the creditworthiness of significant customers based on ongoing credit evaluations. We will also maintain a sales allowance to reserve for potential credits issued to customers. We will determine the amount of the reserve based on historical credit issued.
There were no provisions for doubtful accounts recorded at September 30, 2024 and December 31, 2023. The Company recorded $
| 9 |
| Table of Contents |
Inventory
Inventory is valued at the lower of cost or net realizable value using the first-in, first-out (FIFO) method. Inventory on the balance sheet consists of work-in process.
|
| September 30, 2024 |
|
| December 31, 2023 |
| ||
Finished goods |
| $ |
|
| $ |
| ||
Total inventory |
| $ |
|
| $ |
| ||
During the nine months ended September 30, 2024 and 2023, the Company determined that $
Stock Based Compensation
The Company accounts for stock-based compensation under the provisions of ASC 718, Compensation-Stock Compensation. Stock-based compensation expense for employees and non-employees is measured at the grant date fair value.
Per Share Information
Basic earnings per share are calculated using the weighted average number of common shares outstanding for the period presented. Diluted earnings per share is computed using the weighted-average number of common shares and, if dilutive, potential common shares outstanding during the period. The dilutive effect of potential common shares is not reflected in diluted earnings per share because the Company incurred net losses for the three and nine months ended September 30, 2024 and the three and nine months ended September 30, 2023 and the effect of including these potential common shares in the net loss per share calculations would be anti-dilutive.
The total potential common shares as of September 30, 2024 included
| 10 |
| Table of Contents |
Patents
Patents are stated on the balance sheet at cost. Costs, such as filing fees with patent granting agencies and legal fees directly relating to those filings, incurred to file patent applications were capitalized when the Company believed that there was a high likelihood that the patent would be issued and there would be future economic benefit associated with the patent. These costs were amortized from the date of the patent application on a
Accumulated amortization as of September 30, 2024 and December 31, 2023 was $
Future Amortization Expense
Year |
| Amount |
| |
2024 (remaining) |
| $ |
| |
2025 |
|
|
| |
2026 |
|
|
| |
2027 |
|
|
| |
2028 |
|
|
| |
Thereafter |
|
|
| |
|
| $ |
| |
Impairment of Long-lived Assets
The Company applies the provisions of ASC 360, Property, Plant and Equipment, where applicable to all long-lived assets. ASC 360 addresses accounting and reporting for impairment and disposal of long-lived assets. The Company periodically evaluates the carrying value of long-lived assets to be held and used in accordance with ASC 360. ASC 360 requires impairment losses to be recorded on long-lived assets used in operations when indicators of impairment are present and the undiscounted cash flows estimated to be generated by those assets are less than the assets’ carrying amounts. In that event, a loss is recognized based on the amount by which the carrying amount exceeds the fair market value of the long-lived assets. Loss on long-lived assets to be disposed of is determined in a similar manner, except that fair market values are reduced for the cost of disposal.
When long-lived assets are sold or retired, the related cost and accumulated depreciation or amortization are removed from the accounts and any gain or loss is included in the results of operations. During the nine months ended September 30, 2024 and 2023, the Company determined no impairment was required.
| 11 |
| Table of Contents |
Deferred Offering Costs
Deferred offering costs represent specific incremental costs directly attributable to the offering of securities. The deferred offering costs are recorded as an offset to additional paid-in capital and charged against the proceeds received.
Advertising and Marketing Costs
Advertising and marketing expenses are expensed as incurred. The Company incurred $
Research and Development
The Company charges research and development costs to expense when incurred. The Company incurred $
Leases
The Company follows the provisions of ASC 842, and records right-of-use (“ROU”) assets and lease obligations for its operating leases, which are initially recognized based on the discounted future lease payments over the term of the lease. If the rate implicit in the Company's leases is not readily determinable, the Company's applicable incremental borrowing rate is used in calculating the present value of the sum of the lease payments.
The lease term is defined as the non-cancelable period of the lease plus any options to extend or terminate the lease when it is reasonably certain that the Company will exercise the option. The Company has elected not to recognize ROU asset and lease obligations for its short-term leases, which are defined as leases with an initial term of 12 months or less.
Reclassification
Certain accounts from prior periods have been reclassified to conform to the current period presentation.
New Accounting Pronouncements
The Company considers all new pronouncements and management has determined that there have been no recently adopted or issued accounting standards that had or will have a material impact on its financial statements.
| 12 |
| Table of Contents |
Note 3. Related Party Transactions
Convertible notes payable - related parties
During the year ended December 31, 2022, Brian Thom, the Company’s Chief Executive Officer, converted $
The note is convertible into common stock of the Company at $
During the year ended December 31, 2022, Robert Denser, a Director of the Company, loaned the Company $
The note is convertible into common stock of the Company at $
Interest expense – related party on the above convertible notes payable was $
Loans payable – related parties
During the year ended December 31, 2022, Kristofer Heaton, the Principal Financial Officer, loaned the Company $
Interest expense – related party on the above loan was $
Accrued liabilities – related parties
As of September 30, 2024 and December 31, 2023, $
| 13 |
| Table of Contents |
Note 4. Convertible Notes
During the year ended December 31, 2022, the Company issued a $
The notes are convertible into common stock of the Company at $
Interest expense on the above convertible notes payable was $
Note 5. Notes Payable
During the nine months ended September 30, 2024, the Company issued a $
Note 6. Issuances of Securities
Share issuances 2023
During the nine months ended September 30, 2023, the Company had the following common stock transactions:
| · | |
| · | |
| · | 7,515,000 shares of common stock were sold for $ |
| · |
Share issuances 2024
During the nine months ended September 30, 2024, the Company had the following common stock transactions:
| · |
White Lion Common Stock Purchase Agreement (CSPA)
Restricted stock units
As of September 30, 2024 and December 31, 2023, the Company has
Management is unable to predict if or when a Covered Transaction or Triggering Event under the RSU Agreements governing the restricted stock units will occur and as of September 30, 2024, there was $
| 14 |
| Table of Contents |
Activity related to our restricted stock units during the nine months ended September 30, 2024 was as follows:
|
|
|
|
| Weighted |
| ||
|
|
|
|
| Average |
| ||
|
|
|
|
| Grant |
| ||
|
| Number of |
|
| Date Fair |
| ||
|
| Units |
|
| Value |
| ||
Total awards outstanding at December 31, 2023 |
|
|
|
| $ |
| ||
Units granted |
|
| - |
|
| $ |
| |
Units Exercised/Released |
|
| - |
|
| $ |
| |
Units Cancelled/Forfeited |
|
| - |
|
| $ |
| |
Total awards outstanding at September 30, 2024 |
|
|
|
| $ |
| ||
Note 7. Litigation
Effective as of March 31, 2023, a 2018 lawsuit filed by Philip Forman, against the Company and its former CEO relating to the validity of a June 25, 2015 Amendment to his November 10, 2014 Employment Agreement with the Company and claims for compensation on termination of his employment was settled. In the settlement, as full and complete consideration, the Company issued to Mr. Forman
Note 8. Other Income
During the nine months ended September 30, 2024, the Company entered into a settlement agreement with one of its vendors related to outstanding invoices. The Company paid $
Note 9. Leases
Operating lease right-of-use (“ROU”) assets and liabilities are recognized at commencement date based on the present value of lease payments over the lease term. ROU assets represent our right to use an underlying asset for the lease term and lease liabilities represent our obligation to make lease payments arising from the lease. On the commencement date of the lease, the Company recorded $
| 15 |
| Table of Contents |
The components of lease expense and supplemental cash flow information related to the lease for the period are as follows:
|
| Nine Months Ended September 30, 2024 |
|
| Nine Months Ended September 30, 2023 |
| ||
Lease Cost |
|
|
|
|
|
| ||
Operating lease cost (included in general and administrative in the Company’s statement of operations) |
| $ |
|
| $ |
| ||
|
|
|
|
|
|
|
|
|
Other Information |
|
|
|
|
|
|
|
|
Cash paid for amounts included in the measurement of lease liabilities for the nine months ended September 30, 2024 and 2023 |
| $ |
|
| $ |
| ||
Weighted average remaining lease term – operating leases (in years) |
|
|
|
| ||||
Average discount rate – operating lease |
|
| % |
|
| % | ||
The supplemental balance sheet information related to leases for the period is as follows:
|
| At September 30, 2024 |
|
| At December 31, 2023 |
| ||
Operating leases |
|
|
|
|
|
| ||
Remaining right-of-use assets |
| $ |
|
| $ |
| ||
|
|
|
|
|
|
|
|
|
Short-term operating lease liabilities |
| $ |
|
| $ |
| ||
Long-term operating lease liabilities |
| $ |
|
| $ |
| ||
Total operating lease liabilities |
| $ |
|
| $ |
| ||
Maturities of the Company’s undiscounted lease liabilities are as follows:
Year Ending |
| Operating Leases |
| |
2024 (Remaining) |
| $ |
| |
2025 |
|
|
| |
2026 |
|
|
| |
Total lease payments |
|
|
| |
Less: Imputed interest/present value discount |
|
| ( | ) |
Present value of lease liabilities |
| $ |
| |
Note 10. Subsequent Events
The Company has evaluated events from September 30, 2024, through the date whereupon the financial statements were issued and has determined that there are no material events that need to be disclosed except as follows:
The Company sold
In October 2024, the outstanding note payable was amended and the number of days the contemplated investment or similar investment could be completed was changed from sixty days to one hundred twenty (120) days.
| 16 |
| Table of Contents |
Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations.
You should read the following discussion and analysis of our financial condition and results of operations together with our condensed financial statements and related notes appearing elsewhere in this quarterly report on Form 10-Q. This discussion and analysis contains forward-looking statements that involve risks, uncertainties and assumptions. The actual results may differ materially from those anticipated in these forward-looking statements as a result of certain factors, including, but not limited to, those set forth under ‘Risk Factors’ in our annual report on Form 10-K for the fiscal year ended December 31, 2023, filed with SEC on April 1, 2024.
Company Overview
UHP develops, manufactures, and markets a patented hemostatic gauze for the healthcare and wound care sectors. Our gauze product, CelluSTAT®, is derived from cotton and designed to absorb exudate/drainage from superficial wounds and help control bleeding. We are in the process of seeking regulatory approval to sell our hemostatic gauze product line into the U.S. Class III and European CE Mark human surgical markets.
Our CelluSTAT Gauze Products
CelluSTAT hemostatic gauze is a natural substance created from chemically treated cellulose derived from cotton. It is an effective hemostatic agent registered with the FDA for superficial use under a 510(k) approval obtained in 2012 to help control bleeding from open wounds and body cavities. The CelluSTAT hemostatic material contains no chemical additives, thrombin, collagen or animal-derived products, and is hypoallergenic. When the product comes in contact with blood it expands slightly and quickly converts to a translucent gel that subsequently breaks down into cellulose and salts. Because of its benign impact on body tissue and the fact that it degrades to non-toxic end products, CelluSTAT does not impede the healing of body tissue as compared to certain competing hemostatic products.
CelluSTAT (formerly branded as HemoStyp) hemostatic gauze is a flexible, silk-like material that is applied by placing the gauze onto the bleeding tissue. The supple material can be easily folded and manipulated as needed to fit the size of the wound or incision. In surface bleeding and surgical situations, the product quickly converts to a translucent gel that allows the physician or surgeon to monitor the coagulation process. The gel maintains a neutral pH level, which avoids damaging the surrounding tissue. In superficial bleeding situations, CelluSTAT can be bonded to an adhesive plastic bandage or integrated into a traditional gauze component to address a broad range of needs, including traumatic bleeding injuries and prolonged bleeding following hemodialysis.
Background and Developments
In 2012, the Company began marketing its CelluSTAT hemostatic gauze for human topical and dental applications as well as for and veterinary surgical applications under an FDA 510k approval.
In 2018, the Company determined to pursue a Class III designation to market its hemostatic gauze under an FDA Premarket Approval as an adjunct product to achieve hemostasis in human surgical applications. In February 2018, the Company completed and submitted to the FDA all materials relevant for the pre-market approval (or PMA) for CelluSTAT as a Class III application for internal surgical procedures. Since our initial PMA submission, we have conducted a human trial and have worked to address certain deficiencies in our PMA application that were identified by the FDA.
On March 21, 2024, we submitted results of the human clinical trial and other information, including our manufacturing, sterilization and shipping processes, to the FDA. On June 18, 2024, the FDA issued a customary "Deficiencies Letter" to the company listing certain questions and comments on various elements of the application. The letter contained approximately 40 specific comments and requests for additional information covering the device description, sterility & shelf life, clinical & performance testing, and biocompatibility sections of the PMA application. The FDA's 180-day PMA application review period will be paused while we develop responses to the deficiencies that were identified and will resume once all the responses have been submitted.
17 |
| Table of Contents |
On August 15, 2024, we submitted a Submission Issue Request (SIR) to the FDA outlining its plan to address and respond to the FDA Deficiencies Letter. On September 16, 2024, at the FDA’s request, the Company submitted a condensed list of questions relating to the prior SIR submission. On October 29. 2024, the Company and FDA conducted a virtual meeting to discuss the SIR and the condensed list of questions.
From September 23 through October 4, 2024, the FDA conducted a Bioresearch Monitoring Program (BIMO) Inspection of our records and procedures relating to our 2019 clinical study, following which the FDA delivered its Inspectional Observations on Form 483. On October 25, 2024, we submitted our response to the observations on the Form 483, which the FDA will consider in developing its final report on the BIMO Inspection.
On October 29, 2024, the Company and its regulatory consultant met with the FDA’s PMA application review committee. The purpose of the meeting was to present, discuss and seek feedback from the FDA on our proposed resolutions to the deficiencies. Topics discussed include our clinical testing (including the results of the human trial), biocompatibility, product sterilization and shelf life.
During the discussion, the Company noted the results of its clinical trial involving 232 patients (of whom 118 were treated with its hemostatic gauze) that showed both non-inferiority and superiority for time to hemostasis using CelluSTAT relative to the standard of care and showed no evidence of heterogeneity of results across procedure categories, surgeons, or clinical sites, indicating both poolability and generalizability of study results. The Company also noted that none of the adverse events that occurred during the study were attributable to its hemostatic gauze product.
The FDA requested more data to confirm the safety and effectiveness of CelluSTAT in surgical procedures in the intestinal and thoracic organ space, where organ movement can impact the post operative stability of a hemostat and where observation of post operative rebleeding is more difficult. To address this concern, we have proposed to enroll a limited number of human subjects in a multi-site study as an extension of the original pivotal study, with patients undergoing surgical procedures within the organ space. The supplemental study process will consist of submitting an Investigational Device Exemption (IDE) for FDA approval, identifying and contracting suitable surgical sites, enrolling patents, and data collection and analysis.
There can be no assurance that our PMA application will be approved.
Potential Target Markets
Our CelluSTAT material is currently cut to several sizes and configuration and marketed as CelluSTAT Gauze. While we have paused our commercial activities to focus on our Class III PMA application, our potential customer base includes, without limitation, the following:
| · | Hospitals and Surgery Centers for all Internal Surgical usage (in the event we obtain FDA Class III approval) |
| · | Hospitals, Clinics and Physicians for external trauma |
| · | EMS, Fire Departments and other First Responders |
| · | Military Medical Care Providers |
| · | Hemodialysis centers |
| · | Nursing Homes and Assisted Living Facilities |
| · | Dental and Oral & Maxillofacial Surgery Offices |
| · | Veterinary hospitals |
Primary Strategy
Our CelluSTAT technology received an FDA 510(k) approval in 2012 for use in external or superficial bleeding situations and we believe there is an opportunity for CelluSTAT products to address unmet needs in several medical applications that represent attractive commercial opportunities. However, the Class III human surgical markets, both domestic and international, represent the most attractive market for our products due to the smaller number of competitors offering Class III approved hemostatic agents and the resulting premium pricing for products that can meet the demanding requirements of the human surgical environment. We believe that our extensive laboratory testing and our completed human trial indicate that the CelluSTAT technology could successfully compete against established Class III market participants, and could gain a significant market share. As discussed above, we are in the process of seeking FDA pre-market approval for our CelluSTAT product. There can be no assurance that an FDA PMA will be granted.
In anticipation of receiving a Class III PMA (which cannot be assured), we are evaluating paths to rapidly grow our revenue and profits in all potential market segments, with the objective of maximizing shareholder value. We do not intend to pursue the full commercialization of our products independently nor to remain an independent company in the long term. Options under consideration include (i) a sale or merger of the Company with an industry leader in the wound care and surgical device sectors, which may include a pre-sale collaboration on commercialization and distribution and (ii) one or more commercial partnerships with established market participants, without any specific, associated sale or merger transaction.
| 18 |
| Table of Contents |
The Company has been contacted by several medical technology companies that are active in the surgical equipment and hemostatic products sectors, and who have expressed an interest in the Company’s products and business strategy. We continue to evaluate the potential commercial partnerships in anticipation of an FDA decision on our Class III PMA application. No assurances can be given that the Company will identify any commercialization candidate(s) or enter into a transaction.
Manufacturing and Packaging of our Products
The Company’s products will be manufactured to our specifications through a contract manufacturing arrangement with an FDA certified supplier that maintains stringent quality control protocols to assure the uniformity and quality of all of our gauze products. Information on the manufacturing process and our manufacturer’s facility has been submitted as part of our PMA submission. Our gauze products are cut to size, packaged and sterilized by service providers in the United States.
Patents and Trademarks
Our hemostatic gauze technology is protected through patents granted by the U.S. Patent and Trademark Office, which protection currently runs through 2029.
The Company has registered trademarks and trademark applications for the following product formats:
| · | BooBoo Strips |
| · | HEMOSTYP |
| · | The Ultimate Bandage |
| · | HemoStrip |
| · | CelluSTAT |
| · | Nik Fix |
| 19 |
| Table of Contents |
Results of Operations for the three months ending September 30, 2024 and 2023
The following table sets forth a summary of certain key financial information for the three months ended September 30, 2024 and 2023:
|
| For the Three Months Ended September 30, |
| |||||
|
| 2024 |
|
| 2023 |
| ||
|
|
|
|
|
|
| ||
Revenue |
| $ | - |
|
| $ | - |
|
|
|
|
|
|
|
|
|
|
Gross profit |
| $ | - |
|
| $ | - |
|
|
|
|
|
|
|
|
|
|
Operating (expenses) |
| $ | (391,903 | ) |
| $ | (450,451 | ) |
|
|
|
|
|
|
|
|
|
Operating (loss) |
| $ | (391,903 | ) |
| $ | (450,451 | ) |
|
|
|
|
|
|
|
|
|
Other income (expense) |
| $ | 88,241 |
|
| $ | (35,281 | ) |
|
|
|
|
|
|
|
|
|
Net (loss) |
| $ | (303,662 | ) |
| $ | (485,732 | ) |
|
|
|
|
|
|
|
|
|
Net loss per common share - basic and diluted |
| $ | (0.00 | ) |
| $ | (0.00 | ) |
Three Months ended September 30, 2024 versus Three Months ended September 30, 2023
During the three months ended September 30, 2024 and 2023, the Company had $0 of revenues. The Company did not generate any revenues due to the continued focus of the Company’s capital and resources towards obtaining a Class III PMA.
Operating Expenses
Total operating expenses for the three months ended September 30, 2024 and 2023 were $391,903 and $450,451, respectively.
The decrease in operating expenses for the three months ended September 30, 2024 was primarily due to the Company having a decrease in research and development expenses of $55,876.
Other income (expense)
Other income (expense) for the three months ended September 30, 2024 and 2023 was $88,241 and $(35,281), respectively. The decrease in other expense was primarily due to the Company paying $55,532 to settle approximately $171,000 of accounts payable resulting in a $115,085 gain on settlement of debt.
Our net loss for the three months ended September 30, 2024 was $303,662 as compared to net loss of $485,732 for the comparable period of the prior year. The decrease in the net loss is due to the Company having a decrease in operating expenses of $58,548 and a decrease in other expense of $123,522, as explained above.
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Results of Operations for the nine months ending September 30, 2024 and 2023
The following table sets forth a summary of certain key financial information for the nine months ended September 30, 2024 and 2023:
|
| For the Nine Months Ended September 30, |
| |||||
|
| 2024 |
|
| 2023 |
| ||
|
|
|
|
|
|
| ||
Revenue |
| $ | - |
|
| $ | - |
|
|
|
|
|
|
|
|
|
|
Gross profit |
| $ | - |
|
| $ | - |
|
|
|
|
|
|
|
|
|
|
Operating (expenses) |
| $ | (1,222,174 | ) |
| $ | (1,979,882 | ) |
|
|
|
|
|
|
|
|
|
Operating (loss) |
| $ | (1,222,174 | ) |
| $ | (1,979,882 | ) |
|
|
|
|
|
|
|
|
|
Other income (expense) |
| $ | 34,553 |
|
| $ | (171,467 | ) |
|
|
|
|
|
|
|
|
|
Net (loss) |
| $ | (1,187,621 | ) |
| $ | (2,151,349 | ) |
|
|
|
|
|
|
|
|
|
Net loss per common share - basic and diluted |
| $ | (0.00 | ) |
| $ | (0.01 | ) |
Nine Months ended September 30, 2024 versus Nine Months ended September 30, 2023
During the nine months ended September 30, 2024 and 2023, the Company had $0 of revenues. The Company did not generate any revenues due to the continued focus of the Company’s capital and resources towards obtaining a Class III PMA.
Operating Expenses
Total operating expenses for the nine months ended September 30, 2024 and 2023 were $1,222,174 and $1,979,882, respectively.
The decrease in operating expenses was primarily due to a decrease of $462,500 in litigation settlement expenses, a decrease of $132,015 in legal and professional expenses and research and development expenses decreasing $198,393 to $247,157 during the nine months ended September 30, 2024 from $445,550 in the nine months ended September 30, 2023.
Other income (expense)
Other income (expense) for the nine months ended September 30, 2024 and 2023 was $34,553 and $(171,467), respectively. The change in other income (expense) was primarily due to the Company having a $115,085 gain on settlement in the current period and having a loss on settlement of debt of $80,532 in the comparable period from the prior year.
Our net loss for the nine months ended September 30, 2024 was $1,187,621 compared to net loss of $2,151,349 for the comparable period of the prior year. The decrease in the net loss was due to the Company having a decrease in operating expenses of $757,708 and a decrease in other expenses of $206,020 as explained above.
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| Table of Contents |
Financial Condition, Liquidity and Capital Resources
As of September 30, 2024, the Company had a negative working capital of $2,171,720. The Company has not yet attained a level of operations which will allow it to meet its current overhead expense obligations. The report of our independent registered public accounting firm on our 2023 financial statements includes an explanatory paragraph expressing substantial doubt about our ability to continue as a going concern. The Company has been focusing its capital and resources towards seeking a Class III PMA for its CelluSTAT technology, and has funded its initial operations with private placements, and unsecured loans from related parties. There can be no assurance that adequate financing will continue to be available to the Company and, if available, on terms that are favorable to the Company. Our ability to continue as a going concern is also dependent on many events outside of our direct control, including, among other things, our ability to achieve our business goals and objectives, as well as improvement in the economic climate.
The Company entered into a common stock purchase agreement (“CSPA”) with White Lion, which gives the Company the right, but not the obligation, to require White Lion to purchase up to $10,000,000 of the Company’s common stock, subject to certain limitations and conditions set forth in the CSPA. As of the date of this filing, the Company has received approximately $3.2 million in proceeds from White Lion to pay for its operations and finalization of its Class III PMA application. The sale of additional equity or convertible debt securities would be dilutive to our shareholders. In addition, economic conditions and actions by policymaking bodies are contributing to rising interest rates and significant capital market volatility, which, along with increases in our borrowing levels, could increase our future borrowing costs.
Cash Flows
The Company’s cash on hand at September 30, 2024 and December 31, 2023 was $43,783 and $95,420, respectively.
The following table summarizes selected items from our statements of cash flows for the nine months ended September 30, 2024 and 2023:
|
| For the Nine Months Ended September 30, |
| |||||
|
| 2024 |
|
| 2023 |
| ||
Net cash used in operating activities |
| $ | (1,013,278 | ) |
| $ | (1,624,145 | ) |
Net cash used in investing activities |
|
| - |
|
|
| (2,850 | ) |
Net cash provided by financing activities |
|
| 961,641 |
|
|
| 1,687,657 |
|
|
|
|
|
|
|
|
|
|
Net increase (decrease) in cash and cash equivalents |
| $ | (51,637 | ) |
| $ | 60,662 |
|
Net Cash Used in Operating Activities
Net cash used in operating activities for the nine months ended September 30, 2024 was $1,013,278. The Company had a net loss of $1,187,621 and a gain on settlement of debt of $115,085 offset by amortization expense of $3,038, write-off of inventory of $33,598, amortization of right-of-use asset of $582, a decrease in prepaid and other current assets of $2,896, an increase in accrued liabilities - related party of $195,193 and an increase in accounts payable and accrued expenses of $54,121.
Net cash used in operating activities for the nine months ended September 30, 2023 was $1,624,145. The Company had net loss of $2,151,349 offset by amortization expense of $3,038, amortization of right-of-use asset of $346, amortization of debt discount of $26,502, stock issued for litigation settlement of $462,500, a loss on debt settlement of $80,532, a decrease in inventory of $1,132, an increase in prepaid and other current assets of $7,504 and an increase in accrued liabilities - related party of $224,698. The Company also had a decrease in accounts payable and accrued expenses of $14,040 and a decrease in accrued litigation settlement of $250,000.
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| Table of Contents |
Net Cash Used in Investing Activities
The Company did not have any investing activities during the nine months ended September 30, 2024.
The Company paid $2,850 related to a security deposit during the nine months ended September 30, 2023.
Net Cash Provided by Financing Activities
Net cash provided by financing activities for the nine months ended September 30, 2024 was $961,641. This was due to the result of the Company receiving net proceeds of $811,641 from the sale of common stock and $150,000 in proceeds from a note payable.
Net cash provided by financing activities for the nine months ended September 30, 2023 was $1,687,657. This was due to the result of the Company receiving net proceeds of $1,710,793 from the sale of stock offset by making payments of $19,136 on a loan payable and $4,000 on a loan payable – related party.
Off-Balance Sheet Arrangements
As of September 30, 2024, we have no off-balance sheet arrangements.
Critical Accounting Estimates
The preparation of financial statements in conformity with generally accepted accounting principles of the United States (“GAAP”) requires estimates and assumptions that affect the reported amounts of assets and liabilities, revenues and expenses in the financial statements and accompanying notes. Critical accounting estimates are those estimates made in accordance with GAAP that involve a significant level of estimation uncertainty and have had or are reasonably likely to have a material impact on the financial condition or results of operations of the Company. Based on this definition, we have the critical accounting estimates identified below. We also have other key accounting policies, which involve the use of estimates, judgments, and assumptions that are significant to understanding our results which are found in Note 2 – Significant Accounting Policies of our 2023 Annual Report on Form 10-K and Note 2 – Significant Accounting Policies in the accompanying financial statements. Although we believe that our estimates, assumptions, and judgments are reasonable, they are based upon information presently available. Actual results may differ significantly from these estimates under different assumptions, judgments, or conditions.
Stock-Based Compensation
The Company accounts for stock-based compensation under the provisions of ASC 718, Compensation-Stock Compensation. Stock-based compensation expense for employees and non-employees is measured at the grant date fair value. Stock-based compensation for all stock-based awards to employees and directors is recognized as an expense over the requisite service period, which is generally the vesting period.
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| Table of Contents |
Item 3. Quantitative and Qualitative Disclosures about Market Risk.
Not applicable
Item 4. Controls and Procedures
Evaluation of Disclosure Controls and Procedures
The Company is in the process of implementing disclosure controls and procedures (as defined in Rules 13a-15(e) and 15d-15(e) of the Securities Exchange Act of 1934 (the ‘‘Exchange Act’’), that are designed to ensure that information required to be disclosed in the Company’s Exchange Act reports are recorded, processed, summarized, and reported within the time periods specified in rules and forms of the Securities and Exchange Commission, and that such information is accumulated and communicated to our Chief Executive Officer and Principal Financial Officer to allow timely decisions regarding required disclosure.
As of September 30, 2024, the Chief Executive Officer and the Principal Financial Officer carried out an assessment of the effectiveness of the design and operation of our disclosure controls and procedures and concluded that the Company’s disclosure controls and procedures were not effective.
Changes in Internal Control over Financial Reporting
During the quarter ended September 30, 2024, there were no changes in our system of internal controls over financial reporting.
| 24 |
| Table of Contents |
PART II – OTHER INFORMATION
Item 1. Legal Proceedings
None.
Item 1A. Risk Factors
Except as set forth below, management does not believe there have been any material changes to the risk factors listed in Part I, “Item 1A, Risk Factors” in our annual report on Form 10-K for the year ended December 31, 2023. These risk factors should be carefully considered with the information provided elsewhere in this report, which could materially adversely affect our business, financial condition or results of operations.
We can provide no assurances that the FDA will approve our Class III application for internal surgical procedures in the U.S. market for our CelluSTAT product.
We are reliant on receiving Premarket Approval (PMA) from the FDA for our CelluSTAT product in order to implement our business strategy of targeting the surgical market. If we do not obtain a PMA for our CelluSTAT product, we will have to materially change our strategy, which we cannot assure we would be successful in doing. We submitted our initial PMA application to the FDA in 2018, during 2022 and 2023, the Company worked to address certain deficiencies in its PMA application that were identified by the FDA in 2021. These deficiencies were largely related to the need for standardized procedures for our manufacturing process, and quality assurance procedures for finished, customer ready products.
On March 21, 2024, we submitted results of the human clinical trial and other information, including our manufacturing, sterilization and shipping processes, to the FDA. On June 18, 2024, the FDA issued a customary “Deficiencies Letter” to the company listing certain questions and comments on various elements of the application. The letter contained approximately 40 specific comments and requests for additional information covering the device description, sterility & shelf life, clinical & performance testing, and biocompatibility sections of the PMA application. The FDA’s 180-day PMA application review period will be paused while the Company develops its responses to the deficiencies that were identified, and will resume once all the responses have been submitted.
We cannot be assured that our CelluSTAT product will meet the PMA requirements for FDA approval or that we will ever receive the requisite PMA for our CelluSTAT product.
We are subject to extensive regulation by the FDA and must comply with the regulations of the FDA, as well as state, local and applicable international regulations. Failure to do so could harm our business.
Our CelluSTAT products are subject to extensive regulation by the FDA. These regulations relate to manufacturing, labeling, sale, promotion, distribution and shipping. Before a new medical device, or a new intended use of a legally marketed device, can be marketed in the United States, it must be cleared or approved by the FDA through the applicable 510(k) premarket notification submission, granting of a de novo request, or Premarket Approval (PMA)), unless an exemption applies. The clearance and approval process is expensive, time-consuming, and uncertain. Failure to comply with applicable regulatory requirements of the FDA can result in an enforcement action, which could include a variety of sanctions, including fines, injunctions, civil penalties, recall or seizure of our products, operating restrictions, partial suspension, or total shutdown of production and criminal prosecution. The FDA may change its clearance and approval policies, adopt additional regulations or revise existing regulations, or take other actions, that may prevent or delay approval or clearance of our products or impact our ability to modify our products after clearance on a timely basis. Such policy or regulatory changes could impose additional requirements upon us that could delay our ability to obtain clearance for our products, increase the costs of compliance or restrict our ability to maintain products after clearance.
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| Table of Contents |
The FDA has substantial discretion in the PMA approval process. The FDA can limit or deny approval of a product for many reasons, including, but not limited, to:
· | a product may not be deemed to be safe and effective; |
|
|
· | the FDA may not find the data from clinical trials and preclinical studies sufficient; |
|
|
· | the opportunity for bias in the clinical trials as a result of the open-label design may not be adequately handled and may cause our trial to fail; |
|
|
· | the FDA may not approve suppliers’ processes or facilities; or |
|
|
· | the FDA may change its approval policies or adopt new regulations. |
In addition, regulatory clearance or approval by the FDA does not ensure registration, clearance, approval, or certification by comparable foreign regulatory authorities. Complying with foreign regulatory requirements, including obtaining registrations, clearances, approvals, or certifications, can be expensive and time consuming, and we may not receive regulatory clearances, approvals, or certifications in each country or region in which we plan to market our products or we may be unable to do so on a timely basis. In turn, this could limit our ability to expand into international markets, which could have a material adverse effect on our business, financial condition, and results of operations.
Item 2. Unregistered Sales of Equity Securities and Use of Proceeds
The following summarizes all sales of our unregistered securities from January 1, 2024 through September 30, 2024. The securities in the below-referenced transactions were (i) issued without registration and (ii) were subject to restrictions under the Securities Act and the securities laws of certain states, in reliance on the private offering exemptions contained in Sections 4(a)(2), 4(a)(6) and/or 3(b) of the Securities Act and on Regulation D promulgated under the Securities Act, and in reliance on similar exemptions under applicable state laws as transactions not involving a public offering. No placement or underwriting fees were paid in connection with these transactions. All cash proceeds from the sale of securities were used for working capital purposes.
Date of Sale |
| Title of Security |
| Number Sold |
| Consideration Received |
| Purchaser/Recipient | ||
January 2024 |
| Common Stock |
| 600,000 |
| $122,627 in cash |
| White Lion (1) | ||
February 2024 |
| Common Stock |
| 850,000 |
| $164,973 in cash |
| White Lion (1) | ||
March 2024 |
| Common Stock |
| 600,000 |
| $103,625 in cash |
| White Lion (1) | ||
April 2024 |
| Common Stock |
| 1,100,000 |
| $183,082 in cash |
| White Lion (1) | ||
May 2024 |
| Common Stock |
| 150,000 |
| $22,032 in cash |
| White Lion (1) | ||
June 2024 |
| Common Stock |
| 150,000 |
| $20,476 in cash |
| White Lion (1) | ||
August 2024 |
| Common Stock |
| 500,000 |
| $71,616 in cash |
| White Lion (2) | ||
September 2024 |
| Common Stock |
| 900,000 |
| $123,210 in cash |
| White Lion (2) | ||
| (1)
| Issued by the Company to White Lion Capital, LLC pursuant to the terms of the Common Stock Purchase Agreement dated September 1, 2022, as amended January 25, 2023. |
|
|
|
| (2) | Issued by the Company to White Lion Capital, LLC pursuant to the terms of the Common Stock Purchase Agreement dated September 1, 2022, as amended June 20, 2024. |
Item 3. Defaults Upon Senior Securities
None.
Item 4. Mine Safety Disclosures
Not applicable.
Item 5. Other Information
Not applicable.
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| Table of Contents |
Item 6. Exhibits
The following exhibits are filed with this report, or incorporated by reference as noted:
| 27 |
| Table of Contents |
101.INS |
| Inline XBRL Instance Document (the instance document does not appear in the Interactive Data File because its XBRL tags are embedded within the Inline XBRL document). |
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101.SCH |
| Inline XBRL Taxonomy Extension Schema Document. |
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101.CAL |
| Inline XBRL Taxonomy Extension Calculation Linkbase Document. |
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101.DEF |
| Inline XBRL Taxonomy Extension Definition Linkbase Document. |
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101.LAB |
| Inline XBRL Taxonomy Extension Labels Linkbase Document. |
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101.PRE |
| Inline XBRL Taxonomy Extension Presentation Linkbase Document. |
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104 |
| Cover Page Interactive Data File (formatted as inline XBRL and contained in Exhibit 101). |
___________
* Filed herewith.
(1) | Incorporated by reference to the Company’s Form 10-Q for the quarter ended September 30, 2014. |
|
|
(2) | Incorporated by reference to the Company’s Form 10-Q for the quarter ended June 30, 2022. |
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|
(3) | Incorporated by reference to Form 8-K dated August 7, 2015 – date of earliest event filed on August 10, 2015. |
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(4) | Incorporated by reference to the Company’s Form 10-Q for the quarter ended June 30, 2018 |
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(5) | Incorporated by reference to the Company’s Form 10-K for the year ended December 31, 2018 |
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(6) | Incorporated by reference to the Form 8-K dated December 2, 2020 |
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(7) | Incorporated by reference to the Form 8-K dated January 11, 2021 |
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(8) | Incorporated by reference to the Form 8-K dated June 23, 2022 |
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(9) | Incorporated by reference to the Form 8-K dated September 1, 2022 |
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(10) | Incorporated by reference to the Company’s Form 10-K for the year ended December 31, 2022 |
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(11) | Incorporated by reference to the Form 8-K dated June 25, 2024 |
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(12) | Incorporated by reference to Form S-8 dated November 1, 2019 |
| 28 |
| Table of Contents |
SIGNATURES
Pursuant to the requirements Section 13 or 15(d) of the Securities Exchange Act of 1934, the Registrant has caused this Report to be signed on its behalf by the undersigned, thereunto duly authorized.
UNITED HEALTH PRODUCTS, INC. | |||
Dated: November 12, 2024 | By: | /s/ Brian Thom | |
Brian Thom | |||
Principal Executive Officer | |||
Pursuant to the requirements of the Securities Exchange Act of 1934, this Report has been signed below by the following persons on behalf of the Registrant and in the capacities and on the dates indicated:
Signatures | Title | Date | |||
By: | /s/ Brian Thom |
| November 12, 2024 | ||
Brian Thom | Chief Executive Officer, Principal Executive Officer and Director | ||||
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By: | /s/ Kristofer Heaton | Principal Financial Officer | November 12, 2024 | ||
Kristofer Heaton |
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By: | /s/ Robert Denser | Director | November 12, 2024 | ||
Robert Denser | |||||
| 29 |