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UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

FORM 10-Q

☒	QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

For the quarterly period ended September 30, 2024

☐	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: 000-27781

UNITED HEALTH PRODUCTS, INC.

(Exact name of Company as specified in its charter)

Nevada

84-1517723

(State or other jurisdiction

of incorporation or organization)

(I.R.S. Employer

Identification No.)

520 Fellowship Road, Suite #D-406

Mt. Laurel, NJ

08054

(Address of Company’s principal executive offices)

(Zip Code)

(475) 755-1005

(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. Yes ☒ No ☐

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). Yes ☒ No ☐

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	☐
Non-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 ☐ No ☒

The number of shares issued and outstanding of the Registrant’s Common Stock, as of November 12, 2024 was 250,083,222.

UNITED HEALTH PRODUCTS, INC.

FORM 10-Q QUARTERLY REPORT

TABLE OF CONTENTS

		PAGE
PART I. FINANCIAL INFORMATION

Item 1.	Financial Statements (Unaudited)	3

	Condensed Balance Sheets as of September 30, 2024 (unaudited) and December 31, 2023	3

	Condensed Statements of Operations for the Three and Nine Months Ended September 30, 2024 and September 30, 2023 (unaudited)	4

	Condensed Statement of Stockholders’ Deficiency for the Three and Nine Months Ended September 30, 2024 and September 30, 2023 (unaudited)	5

	Condensed Statements of Cash Flows for the Nine Months Ended September 30, 2024 and September 30, 2023 (unaudited)	7

	Notes to Condensed Financial Statements (unaudited)	8

Item 2.	Management’s Discussion and Analysis of Financial Condition and Results of Operations	17

Item 3.	Quantitative and Qualitative Disclosures	24

Item 4.	Controls and Procedures	24

PART II. OTHER INFORMATION

Item 1.	Legal Proceedings	25

Item 2.	Unregistered Sales of Equity Securities and Use of Proceeds	25

Item 3.	Defaults Upon Senior Securities	25

Item 4.	Mine Safety Disclosures	25

Item 5.	Other Information	25

Item 6.	Exhibits	27

SIGNATURES		29

Table of Contents

UNITED HEALTH PRODUCTS, INC.

Condensed Balance Sheets

	September 30,			December 31,
	2024			2023
	(Unaudited)
ASSETS
Current Assets
Cash and cash equivalents	$	43,783		$	95,420
Inventory		-			33,598
Prepaid and other current assets		19,908			22,804
Total current assets		63,691			151,822

Deferred offering costs		-			21,051
Operating lease right-of-use asset		54,726			76,520
Security deposit		2,850			2,850
Patents, net		29,362			32,400

TOTAL ASSETS	$	150,629		$	284,643

Current Liabilities
Accounts payable and accrued expenses	$	926,603		$	987,567
Accrued liabilities - related parties		421,668			226,475
Operating lease liability - current		29,640			28,838
Notes payable		150,000			-
Convertible notes payable, net of debt discount		207,500			207,500
Convertible notes payable – related party, net of debt discount		500,000			500,000
Total current liabilities		2,235,411			1,950,380

Operating lease liability – long-term		26,475			48,489
TOTAL LIABILITIES		2,261,886			1,998,869

Commitments and Contingencies		-			-

Stockholders’ Deficit
Series A Convertible Preferred Stock - $0.001 par value, 1,000,000 shares Authorized and 0 shares issued and outstanding		-			-
Common Stock - $0.001 par value, 300,000,000 shares Authorized, 249,633,222 and 244,783,222 shares issued and outstanding at September 30, 2024 and December 31, 2023		249,633			244,783
Additional Paid-In Capital		75,525,941			74,740,201
Accumulated Deficit		(77,886,831	)		(76,699,210	)
Total Stockholders’ Deficit		(2,111,257	)		(1,714,226	)

TOTAL LIABILITIES AND STOCKHOLDERS’ DEFICIT	$	150,629		$	284,643

See notes to unaudited condensed financial statements.

Table of Contents

UNITED HEALTH PRODUCTS, INC.

Condensed Statements of Operations

(Unaudited)

	For the Three Months Ended September 30,						For the Nine Months Ended September 30,
	2024			2023			2024			2023

Revenues	$	-		$	-		$	-		$	-

Operating Costs and Expenses
Selling, general and administrative expenses		326,018			328,690			975,017			1,534,332
Research and development		65,885			121,761			247,157			445,550
Total Operating Expenses		391,903			450,451			1,222,174			1,979,882

Loss from Operations		(391,903	)		(450,451	)		(1,222,174	)		(1,979,882	)

Other Income (Expenses)
Interest expense		(7,613	)		(15,779	)		(22,839	)		(32,435	)
Interest expense – related party		(19,231	)		(19,502	)		(57,693	)		(58,500	)
Gain (loss) on settlement of debt		115,085			-			115,085			(80,532	)
Total Other Income (Expenses)		88,241			(35,281	)		34,553			(171,467	)

Net Income (Loss)	$	(303,662	)	$	(485,732	)	$	(1,187,621	)	$	(2,151,349	)

Net Income (Loss) per common share:
Basic and diluted	$	(0.00	)	$	(0.00	)	$	(0.00	)	$	(0.01	)

Weighted average number of shares outstanding		248,614,744			241,485,939			247,365,704			237,713,870

See notes to unaudited condensed financial statements.

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)

					Additional
	Common Stock				Paid-in			Subscription			Accumulated
	Shares		Amount		Capital			Receivable			Deficit			Total

Balance at December 31, 2022		230,871,034	$	230,871	$	71,830,695		$	(50,550	)	$	(74,075,943	)	$	(2,064,927	)

Sale of common stock		2,535,000		2,535		522,770			50,550			-			575,855

Common stock issued to settle accrued liabilities – related party		637,500		638		168,300			-			-			168,938

Common stock issued to settle accrued liabilities		300,000		300		79,200			-			-			79,500

Common stock issued for a stock subscription receivable		400,000		400		71,317			(71,717	)		-			-

Amortization of deferred offering costs		-		-		(55,371	)		-			-			(55,371	)

Common stock issued for litigation settlement		1,850,000		1,850		460,650			-			-			462,500

Net Loss		-		-		-			-			(1,142,706	)		(1,142,706	)

Balance at March 31, 2023		236,593,534		236,594		73,077,561			(71,717	)		(75,218,649	)		(1,976,211	)

Sale of common stock		2,450,000		2,450		501,558			71,717			-			575,725

Common stock issued to settle accrued liabilities – related party		567,188		566		101,527			-			-			102,093

Common stock issued to settle accrued liabilities		412,500		413		73,838			-			-			74,251

Common stock issued for a stock subscription receivable		1,100,000		1,100		310,720			(311,820	)		-			-

Amortization of deferred offering costs		-		-		(55,387	)		-			-			(55,387	)

Net Loss		-		-		-			-			(522,911	)		(522,911	)

Balance at June 30, 2023		241,123,222		241,123		74,009,817			(311,820	)		(75,741,560	)		(1,802,440	)

Sale of common stock		1,030,000		1,030		246,363			311,820			-			559,213

Amortization of deferred offering costs		-		-		(53,769	)		-			-			(53,769	)

Net loss		-		-		-			-			(485,732	)		(485,732	)

Balance at September 30, 2023		242,153,222	$	242,153	$	74,202,411		$	-		$	(76,227,292	)	$	(1,782,728	)

Table of Contents

					Additional
	Common Stock				Paid-in			Accumulated
	Shares		Amount		Capital			Deficit			Total

Balance at December 31, 2023		244,783,222	$	244,783	$	74,740,201		$	(76,699,210	)	$	(1,714,226	)

Sale of common stock		2,050,000		2,050		389,175			-			391,225

Amortization of deferred offering costs		-		-		(21,051	)		-			(21,051	)

Net Loss		-		-		-			(451,938	)		(451,938	)

Balance at March 31, 2024		246,833,222		246,833		75,108,325			(77,151,148	)		(1,795,990	)

Sale of common stock		1,400,000		1,400		224,190			-			225,590

Net Loss		-		-		-			(432,021	)		(432,021	)

Balance at June 30, 2024		248,233,222		248,233		75,332,515			(77,583,169	)		(2,002,421	)

Sale of common stock		1,400,000		1,400		193,426			-			194,826

Net Loss		-		-		-			(303,662	)		(303,662	)

Balance at September 30, 2024		249,633,222	$	249,633	$	75,525,941		$	(77,886,831	)	$	(2,111,257	)

See notes to unaudited condensed financial statements.

Table of Contents

UNITED HEALTH PRODUCTS, INC.

Condensed Statements of Cash Flows

(Unaudited)

	For the Nine Months Ended September 30,
	2024			2023

Cash Flows from Operating Activities:
Net (Loss)	$	(1,187,621	)	$	(2,151,349	)
Adjustments to Reconcile Net (Loss) to Net Cash Used In Operating Activities:
Write-off of inventory		33,598			-
Amortization of debt discount		-			26,502
Amortization expense		3,038			3,038
Amortization of right-of-use asset		582			346
Stock issued for litigation settlement		-			462,500
(Gain) loss on settlement of debt		(115,085	)		80,532
Changes in assets and liabilities:
Inventory		-			1,132
Prepaid and other current assets		2,896			(7,504	)
Accounts payable and accrued expenses		54,121			(14,040	)
Accrued liabilities – related party		195,193			224,698
Accrued litigation settlement		-			(250,000	)
Net Cash Used In Operating Activities		(1,013,278	)		(1,624,145	)

Cash Flows from Investing Activities:
Security deposit		-			(2,850	)
Net Cash Used in Investing Activities		-			(2,850	)

Cash Flows from Financing Activities:
Repayments on loan payable - related party		-			(4,000	)
Repayments on loan payable		-			(19,136	)
Payment of offering costs		(10,200	)		(12,000	)
Proceeds from sale of common stock		821,841			1,722,793
Proceeds from note payable		150,000			-
Cash flow provided by financing activities		961,641			1,687,657
Increase (decrease) in Cash and Cash Equivalents		(51,637	)		60,662
Cash and Cash Equivalents – Beginning of period		95,420			13,377

CASH AND CASH EQUIVALENTS – END OF PERIOD	$	43,783		$	74,039

Supplemental cash flow information:
Cash paid for interest	$	-		$	15
Cash paid for income taxes	$	-		$	-

Non-cash Investing & Financing Activities:
Amortization of deferred offering costs	$	21,051		$	164,527
Initial recognition of operating lease right-of-use asset and operating lease liability	$	-		$	92,425
Common stock issued to settle accrued liabilities – related party	$	-		$	218,250
Accounts payable and accrued expenses paid with promissory note payable	$	-		$	10,000
Common stock issued to settle accounts payable and accrued liabilities	$	-		$	126,000

See notes to unaudited condensed financial statements.

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.

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 $0 in bad debt expense for the three and nine month periods ended September 30, 2024 and 2023.

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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	$	-	$	33,598
Total inventory	$	-	$	33,598

During the nine months ended September 30, 2024 and 2023, the Company determined that $33,598 and $0 of inventory needed to be impaired and written-off, respectively.

Stock Based Compensation

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 47,665,000 of restricted stock units, 6,014,802 shares for convertible notes payable – related parties and 2,381,108 shares for convertible notes payable. The total potential common shares as of September 30, 2023 included 47,665,000 of restricted stock units, 3,636,957 shares for convertible notes payable – related parties and 1,439,783 shares for convertible notes payable.

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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 straight-line basis over the estimated useful life of 10 years. All costs associated with any abandoned patent applications are expensed.

Accumulated amortization as of September 30, 2024 and December 31, 2023 was $11,138 and $8,100, respectively. Amortization expense for the nine months ended September 30, 2024 and 2023 was $3,038 and $3,038, respectively.

Future Amortization Expense

Year	Amount
2024 (remaining)	$	1,012
2025		4,050
2026		4,050
2027		4,050
2028		4,050
Thereafter		12,150
	$	29,362

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.

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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 $84,616 and $84,320 in advertising and marketing costs during the nine months ended September 30, 2024 and 2023, respectively.

Research and Development

The Company charges research and development costs to expense when incurred. The Company incurred $247,157 and $445,550 in research and development expenses during the nine months ended September 30, 2024 and 2023, respectively.

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.

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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 $372,000 of a loan payable balance to a convertible note payable. The unpaid accrued interest on the loan payable was transferred to a convertible note payable. The note had an interest rate of 10%, an original issue discount (“OID”) of 7% and had a maturity date of December 31, 2023. On December 15, 2023, the Company entered into an amendment on the convertible note, which extended the maturity date to December 31, 2024 and increased the interest rate from 10% to 13%, effective January 1, 2024.

The note is convertible into common stock of the Company at $0.35 per share. In the event the Company issues any shares of common stock before the maturity date at a price that is lower than $0.35 per share, the conversion price shall be reduced to equal such lower issue price per share. The Company recorded $28,000 of a debt discount related to the OID. As of September 30, 2024 and December 31, 2023, the remaining unamortized debt discount was $0, respectively. Accrued interest associated with the note was $123,822 and $77,287 as of September 30, 2024 and December 31, 2023, respectively.

During the year ended December 31, 2022, Robert Denser, a Director of the Company, loaned the Company $93,000 through a convertible note. The note had an interest rate of 10%, an OID of 7% and had a maturity date of December 31, 2023. On December 15, 2023, the Company entered into an amendment on the convertible note, which extended the maturity date to December 31, 2024 and increased the interest rate from 10% to 13%, effective January 1, 2024.

The note is convertible into common stock of the Company at $0.35 per share. In the event the Company issues any shares of common stock before the maturity date at a price that is lower than $0.35 per share, the conversion price shall be reduced to equal such lower issue price per share. The Company recorded $7,000 of a debt discount related to the OID. As of September 30, 2024 and December 31, 2023, the remaining unamortized debt discount was $0, respectively. Accrued interest associated with the note was $25,596 and $14,438 as of September 30, 2024 and December 31, 2023, respectively.

Interest expense – related party on the above convertible notes payable was $19,231 (including $0 of debt discount amortization related to the OID) and $19,491 (including $6,043 of debt discount amortization related to the OID) during the three months ended September 30, 2024 and 2023, respectively. Interest expense – related party on convertible notes payable was $57,693 (including $0 of debt discount amortization related to the OID) and $58,278 (including $17,933 of debt discount amortization related to the OID) during the nine months ended September 30, 2024 and 2023, respectively. Accrued interest – related party due to these convertible notes was $149,418 and $91,725, as of September 30, 2024 and December 31, 2023, respectively.

Loans payable – related parties

During the year ended December 31, 2022, Kristofer Heaton, the Principal Financial Officer, loaned the Company $4,000 to pay for operating expenses. The loan has an interest rate of 10% and was due on demand. During the nine months ended September 30, 2023, the Company repaid $4,000 of principal.

Interest expense – related party on the above loan was $11 during the three months ended September 30, 2023. Interest expense – related party was $222 during the nine months ended September 30, 2023.

Accrued liabilities – related parties

As of September 30, 2024 and December 31, 2023, $272,250 and $134,750 of accrued compensation was due to the Company’s officers and management, respectively.

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Note 4. Convertible Notes

During the year ended December 31, 2022, the Company issued a $100,000 convertible note and a $107,500 convertible note and received total proceeds of $192,975. The notes had an interest rate of 10%, an OID of 7% and had a maturity date of December 31, 2023. On December 15, 2023, the Company entered into an amendment on the convertible notes, which extended the maturity date to December 31, 2024 and increased the interest rate from 10% to 13%, effective January 1, 2024.

The notes are convertible into common stock of the Company at $0.35 per share. In the event the Company issues any shares of common stock before the maturity date at a price that is lower than $0.35 per share, the conversion price shall be reduced to equal such lower issue price per share. The Company recorded $14,525 of a debt discount related to the OID. As of September 30, 2024 and December 31, 2023, the remaining unamortized debt discount was $0 and $0, respectively.

Interest expense on the above convertible notes payable was $7,613 (including $0 of debt discount amortization related to the OID) and $8,135 (including $2,811 of debt discount amortization related to the OID) during the three months ended September 30, 2024 and 2023, respectively. Interest expense was $22,839 (including $0 of debt discount amortization related to the OID) and $24,541 (including $8,569 of debt discount amortization related to the OID) during the nine months ended September 30, 2024 and 2023, respectively. Accrued interest as of September 30, 2024 and December 31, 2023 was $49,588 and $26,749, respectively, and has been recorded in accrued liabilities on the balance sheet.

Note 5. Notes Payable

During the nine months ended September 30, 2024, the Company issued a $150,000 note payable. The note is non-interest bearing and would be repaid by the proceeds of a contemplated future equity investment. In the event the contemplated investment or similar investment is not completed within sixty days of the execution of the note payable, then 100% of any net proceeds received from any external capital raising activities will be used to pay down the note payable until it is paid in full. In October 2024, the 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. As of September 30, 2024 the outstanding balance of the note payable was $150,000.

Note 6. Issuances of Securities

Share issuances 2023

During the nine months ended September 30, 2023, the Company had the following common stock transactions:

	·	1,204,688 shares of common stock with a fair value of $271,031 were issued to officers and management of the Company to settle $218,250 of accrued liabilities resulting in a loss on settlement of debt of $52,781.
	·	712,500 shares of common stock with a fair value of $153,751 were issued to consultants to settle $126,000 of accrued liabilities resulting in a loss on debt settlement of $27,751.
	·	7,515,000 shares of common stock were sold for $1,710,793, net of legal and administrative fees of $12,000 and which included a payment of $50,550 for a subscription receivable, under the Company’s common stock purchase agreement with White Lion.
	·	1,850,000 shares of common stock with a fair value of $462,500 were issued to settle litigation (see Note 7).

Share issuances 2024

During the nine months ended September 30, 2024, the Company had the following common stock transactions:

4,850,000 shares of common stock were sold for $811,641, net of legal and administrative fees of $10,200, under the Company’s common stock purchase agreement with White Lion.

White Lion Common Stock Purchase Agreement (CSPA)

On June 20, 2024, the Company and White Lion amended the CSPA (the “Second Amendment”) to provide that the purchase price to be paid by White Lion for shares of the Company’s common stock pursuant to the CSPA equals the lower of: (i) 93% of the volume-weighted average price of the Company’s common stock during a period of five consecutive trading days following the Company’s exercise of its right to sell shares (or 95% of that volume-weighted average price if the Company’s common stock is trading on a national exchange), or (ii) the closing price of the common stock on the day the Company exercises its right to sell shares, subject to a floor price of $0.25 per share. The Second Amendment further provides that if the Company issues a share price purchase notice at a time that the Company’s common stock is trading below the floor price and White Lion waives the floor price condition, the purchase price to be paid by White Lion for such shares shall equal 90% multiplied by the lower of the (i) three lowest volume-weighted average price of the Company’s common stock during a period of five consecutive trading days following the Company’s exercise of its right to sell shares, or (ii) most recent closing price of the Company’s common stock prior to White Lion’s receipt of a share price purchase notice.

Restricted stock units

As of September 30, 2024 and December 31, 2023, the Company has 47,665,000 restricted stock units (RSU) outstanding. The RSU’s are subject to certain conditions and shall vest upon the achievement of certain Company objectives and milestones.

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 $25,313,630 of unrecognized compensation cost related to unvested restricted stock unit awards.

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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		47,665,000	$	0.54
Units granted		-	$	-
Units Exercised/Released		-	$	-
Units Cancelled/Forfeited		-	$	-
Total awards outstanding at September 30, 2024		47,665,000	$	0.54

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 1,850,000 shares of common stock of the Company with a fair value of $462,500.

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 $55,532 to the vendor related to outstanding invoices of approximately $171,000 resulting in a gain on settlement of $115,085. The gain of $115,085 was recorded as other income in the statement of operations.

Note 9. Leases

In May 2023, the Company entered into 36-month operating lease, which provides for approximately 1,800 square feet of office space, that commenced on June 1, 2023 and ends on May 31, 2026. The lease required a $2,850 security deposit and monthly lease payments are $2,850 the first year of the lease, $2,964 the second year and $3,082 the third year. The Company or landlord may terminate the lease at the expiration date by giving to the other party written notice at least ninety (90) days prior to the expiration date. The lease may be renewed for a term of one (1) year.

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 $92,425 related to the ROU asset and lease liability.

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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)	$	26,232		$	11,746

Other Information
Cash paid for amounts included in the measurement of lease liabilities for the nine months ended September 30, 2024 and 2023	$	25,650		$	11,400
Weighted average remaining lease term – operating leases (in years)		1.67 years			2.67 years
Average discount rate – operating lease		10	%		10	%

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	$	54,726	$	76,520

Short-term operating lease liabilities	$	29,640	$	28,838
Long-term operating lease liabilities	$	26,475	$	48,489
Total operating lease liabilities	$	56,115	$	77,327

Maturities of the Company’s undiscounted lease liabilities are as follows:

Year Ending	Operating Leases
2024 (Remaining)	$	8,891
2025		36,394
2026		15,410
Total lease payments		60,695
Less: Imputed interest/present value discount		(4,580	)
Present value of lease liabilities	$	56,115

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 450,000 shares of common stock to White Lion for net proceeds of $40,539 after $1,200 of administrative fees were deducted.

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.

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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.

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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.

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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

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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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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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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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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.

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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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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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Item 6. Exhibits

The following exhibits are filed with this report, or incorporated by reference as noted:

3.1		Articles of Incorporation of the Company dated February 28, 1997 (1)

3.2		Amendment to Articles of Incorporation (1)

3.3		By-laws of the Company (2)

3.4		August 2015 Amendment to Articles of Incorporation (3)

10.1		Services Agreement with Louis Schiliro (4)

10.2		Restricted Stock Unit Agreement – Louis Schiliro (5)

10.3		Services Agreement with Brian Thom (6)

10.4		Restricted Stock Unit Agreement - Brian Thom (6)

10.5		Services Agreement with Kristofer Heaton (7)

10.6		Restricted Stock Unit Agreement - Kristofer Heaton (7)

10.7		Amendment to Restricted Stock Unit Agreement – Brian Thom (8)

10.8		Restricted Stock Unit Agreement – Robert Denser (8)

10.9		Stock Purchase Agreement dated September 1, 2022 between the Company and White Lion Capital LLC (9)

10.10		Amendment to Stock Purchase Agreement dated January 25, 2023 (10)

10.11		Amendment No. 2 to Common Stock Purchase Agreement (11)

21		Subsidiaries of the Registrant - None

31.1		Certification of Principal Executive Officer*

31.2		Certification of Principal Financial Officer*

32.1		Section 1350 Certificate by Principal Executive Officer*

32.2		Section 1350 Certificate by Principal Financial Officer*

99.1		2019 Employee Benefit and Consulting Services Compensation Plan (12)

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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).

101.SCH		Inline XBRL Taxonomy Extension Schema Document.

101.CAL		Inline XBRL Taxonomy Extension Calculation Linkbase Document.

101.DEF		Inline XBRL Taxonomy Extension Definition Linkbase Document.

101.LAB		Inline XBRL Taxonomy Extension Labels Linkbase Document.

101.PRE		Inline XBRL Taxonomy Extension Presentation Linkbase Document.

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.

(3)	Incorporated by reference to Form 8-K dated August 7, 2015 – date of earliest event filed on August 10, 2015.

(4)	Incorporated by reference to the Company’s Form 10-Q for the quarter ended June 30, 2018

(5)	Incorporated by reference to the Company’s Form 10-K for the year ended December 31, 2018

(6)	Incorporated by reference to the Form 8-K dated December 2, 2020

(7)	Incorporated by reference to the Form 8-K dated January 11, 2021

(8)	Incorporated by reference to the Form 8-K dated June 23, 2022

(9)	Incorporated by reference to the Form 8-K dated September 1, 2022

(10)	Incorporated by reference to the Company’s Form 10-K for the year ended December 31, 2022

(11)	Incorporated by reference to the Form 8-K dated June 25, 2024

(12)	Incorporated by reference to Form S-8 dated November 1, 2019

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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

By:	/s/ Kristofer Heaton	Principal Financial Officer	November 12, 2024
	Kristofer Heaton

By:	/s/ Robert Denser	Director	November 12, 2024
	Robert Denser

United Health Products, Inc. 10-Q