United Health Products, Inc.

Previous wording

From September 23 through October 4, 2024, the FDA conducted a Bioresearch Monitoring Program (BIMO) Inspection of our records and procedures relating to our clinical study, following which the FDA delivered its Inspectional Observations on Form 483. On October 25, 2024, we submitted our response to the FDA’s observations, which the FDA will consider in developing its final report on the BIMO Inspection. On March 25, 2015, FDA issued a Warning Letter identifying five violations of required clinical procedures occurred during the 2019 clinical trial. On April 14, 2025, we submitted a response to FDA that address the violations. As of the date of this filing, the FDA has not responded to our submission responding to the Warning Letter.

Current wording

From September 23 through October 4, 2024, the FDA conducted a Bioresearch Monitoring Program (BIMO) Inspection of our records and procedures relating to our clinical study, following which the FDA delivered its Inspectional Observations on Form 483. On October 25, 2024, we submitted our response to the FDA’s observations, which the FDA will consider in developing its final report on the BIMO Inspection. On March 25, 2015, FDA issued a Warning Letter identifying five violations of required clinical procedures occurred during the 2019 clinical trial. On April 14, 2025, we submitted a response to FDA that addressed the violations. As of the date of this filing, the FDA has not responded to our submission responding to the Warning Letter.

Previous wording

The timing to resolve the FDA Warning Letter is uncertain. Since the April notice of disapproval of the IDE application, UHP has engaged with the FDA to seek a path to timely approval of a new IDE and commencement of the clinical trial. We have retained a regulatory attorney to support our efforts in this regard and are discussing with the FDA various solutions including, among other options, identifying an alternative sponsor acceptable to the FDA to oversee the clinical study on the Company’s behalf. In such an arrangement, UHP would retain full and exclusive rights to the data and analysis contained in a Clinical Trial Report and incorporate into a revised PMA application.

Current wording

The timing to resolve the FDA Warning Letter is uncertain. Since the April notice of disapproval of our IDE application, UHP has engaged with the FDA to seek a path to timely approval of a new IDE and commencement of the clinical trial. We have retained a regulatory attorney to support our efforts in this regard and are discussing with the FDA various solutions including, among other options, conducting a new pivotal clinical trial that will yield sufficient data to confirm the safety and effectiveness of our product without reliance on data from the 2019 study.

Previous wording

Total operating expenses for the three months ended June 30, 2025 and 2024 were $268,356 and $405,177, respectively.

Current wording

Total operating expenses for the three months ended September 30, 2025 and 2024 were $233,179 and $391,903, respectively.

Previous wording

The decrease in operating expenses for the three months ended June 30, 2025 was primarily due to the Company having a decrease in legal and professional expenses of $135,669, a decrease in obsolete inventory write off of $33,598 offset by an increase in research and development expenses of $15,263, and an increase in marketing activities of $15,404.

Current wording

The decrease in operating expenses for the three months ended September 30, 2025 was primarily due to a decrease in consulting expenses of $158,521 as the Company terminated the services of certain consultants, and a decrease in research and development expenses of $40,551 as the Company purchased fewer external lab testing services, offset by an increase in legal services of $43,480 as the Company retained regulatory counsel to assist in correspondence with the FDA.

Previous wording

Other income (expense) for the three months ended June 30, 2025 and 2024 was $(46,831) and $(26,844), respectively. The increase in other expense was due to an increase in interest expense from the larger outstanding loan balances.

Current wording

Other income (expense) for the three months ended September 30, 2025 and 2024 was $(52,415) and $88,241, respectively. The change in other income (expense) was due to an increase in interest expense of $25,571 from the larger outstanding loan balances and a decrease in gain on settlement of debt of $115,085 from a settlement of accounts payable in the same period of the prior year with no similar settlement in the current period.

Previous wording

Our net loss for the three months ended June 30, 2025 was $315,187 as compared to net loss of $432,021 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 $136,821 offset by an increase in other expense of $19,987, as explained above.

Current wording

Our net loss for the three months ended September 30, 2025 was $285,594 as compared to net loss of $303,662 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 $158,724 offset by an increase in other expense of $140,656, as explained above.

Previous wording

Results of Operations for the six months ending June 30, 2025 and 2024

Current wording

Results of Operations for the nine months ending September 30, 2025 and 2024

Previous wording

The following table sets forth a summary of certain key financial information for the six months ended June 30, 2025 and 2024:

Current wording

The following table sets forth a summary of certain key financial information for the nine months ended September 30, 2025 and 2024:

Previous wording

During the six months ended June 30, 2025 and 2024, the Company had $0 of revenues, respectively. 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.

Current wording

During the nine months ended September 30, 2025 and 2024, the Company had $0 of revenues, respectively. 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.

Previous wording

Total operating expenses for the six months ended June 30, 2025 and 2024 were $1,757,572 and $830,271, respectively.

Current wording

Total operating expenses for the nine months ended September 30, 2025 and 2024 were $1,990,751 and $1,222,174, respectively.

Previous wording

The increase in operating expenses was primarily due to an increase of $1,120,125 in stock-based compensation offset by a decrease of approximately $185,592 in legal and professional expenses. The increase in stock-based compensation is due to the vesting of 4,725,000 RSUs and recording $1,120,125 as stock-based compensation. The decrease in legal and professional expenses is due to the Company terminating services with certain regulatory consultants.

Current wording

The increase in operating expenses was primarily due to an increase of $1,120,125 in stock-based compensation offset by a decrease of approximately $330,058 in professional expenses. The increase in stock-based compensation is due to the vesting of 4,725,000 RSUs and recording $1,120,125 as stock-based compensation. The decrease in professional expenses is due to the Company terminating services with certain consultants.

Previous wording

Our net loss for the six months ended June 30, 2025 was $1,846,846 as compared to net loss of $883,959 for the comparable period of the prior year. The increase in the net loss is due to the Company having an increase in operating expenses of $927,301 and an increase in other expense of $35,586, as explained above.

Current wording

Our net loss for the nine months ended September 30, 2025 was $2,132,440 as compared to net loss of $1,187,621 for the comparable period of the prior year. The increase in the net loss is due to the Company having an increase in operating expenses of $768,577 and an increase in other expense of $176,242, as explained above.

Previous wording

As of June 30, 2025, the Company had a negative working capital of $1,883,479. 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 2024 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.

Current wording

As of September 30, 2025, the Company had a negative working capital of $1,963,227. 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 2024 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.

Previous wording

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.

Current wording

The Company entered into a common stock purchase agreement (“CSPA”) with White Lion, which gave 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. The Commitment Period (as defined in the CSPA) ended on October 1, 2025 and has not been extended. We are evaluating alternatives to raise external capital to fund our operations on terms that minimize dilution to existing shareholders which may include agreements similar to the CSPA.

Previous wording

The Company’s cash on hand at June 30, 2025 and December 31, 2024 was $225 and $168,883, respectively.

Current wording

The Company’s cash on hand at September 30, 2025 and December 31, 2024 was $18,376 and $168,883, respectively.

Previous wording

The following table summarizes selected items from our statements of cash flows for the six months ended June 30, 2025 and 2024:

Current wording

The following table summarizes selected items from our statements of cash flows for the nine months ended September 30, 2025 and 2024:

Previous wording

Net cash used in operating activities for the six months ended June 30, 2025 was $458,658. The Company had a net loss of $1,846,846 offset by stock for services and compensation of $1,120,125, amortization expense of $2,025, amortization of right-of-use asset of $110, an increase in accounts payable and accrued expenses of $125,534, an increase in accrued liabilities - related party of $43,462 and an increase in accrued compensation of $95,238. The Company also had a decrease prepaid and other current assets of $1,914.

Current wording

Net cash used in operating activities for the nine months ended September 30, 2025 was $633,815. The Company had a net loss of $2,132,440, amortization of right-of-use asset of $460, and an increase in prepaid and other current assets of $1,953 offset by stock for services and compensation of $1,120,125, amortization expense of $3,037, an increase in accounts payable and accrued expenses of $237,916, an increase in accrued liabilities - related party of $65,193 and an increase in accrued compensation of $74,767.

Previous wording

Net cash used in operating activities for the six months ended June 30, 2024 was $693,481. The Company had a net loss of $883,959 offset by amortization expense of $2,025, write-off of inventory of $33,598, amortization of right-of-use asset of $578, a decrease in prepaid and other current assets of $15,264, an increase in accrued liabilities - related party of $98,962 and an increase in accounts payable and accrued expenses of $40,051.

Current wording

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.

Previous wording

The Company did not have any investing activities during the six months ended June 30, 2025 and June 30, 2024.

Current wording

The Company did not have any investing activities during the nine months ended September 30, 2025 and September 30, 2024.

Previous wording

Net cash provided by financing activities for the six months ended June 30, 2025 was $290,000. This was due to the result of the Company receiving proceeds of $290,000 from convertible notes, receiving advances from related party of $20,000 offset by repayment of advances from related party of $20,000.

Current wording

Net cash provided by financing activities for the nine months ended September 30, 2025 was $483,308. This was due to the result of the Company receiving proceeds of $420,000 from convertible notes, receiving net proceeds of $63,308 from the sale of common stock, receiving advances from related party of $20,000 offset by repayment of advances from related party of $20,000.

Previous wording

Net cash provided by financing activities for the six months ended June 30, 2024 was $616,815. This was due to the result of the Company receiving net proceeds of $616,815 from the sale of common stock

Current wording

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 $811,841 from the sale of common stock and $150,000 in proceeds from a note payable.