UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

FORM 10-Q

For the quarterly period ended March 31, 2026

For the transition period from ____________ to ____________

Commission file number: 000-27781

(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.

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 May 15, 2026 was 260,385,588.

UNITED HEALTH PRODUCTS, INC.

FORM 10-Q QUARTERLY REPORT

TABLE OF CONTENTS

UNITED HEALTH PRODUCTS, INC.

Condensed Balance Sheets

See notes to unaudited condensed financial statements.

UNITED HEALTH PRODUCTS, INC.

Condensed Statements of Operations

(Unaudited)

See notes to unaudited condensed financial statements.

UNITED HEALTH PRODUCTS, INC

Condensed Statement of Stockholders’ Deficiency

Three Months Ended March 31, 2026 and March 31, 2025

(Unaudited)

See notes to unaudited condensed financial statements.

UNITED HEALTH PRODUCTS, INC.

Condensed Statements of Cash Flows

(Unaudited)

See notes to unaudited condensed financial statements.

UNITED HEALTH PRODUCTS, INC.

NOTES TO CONDENSED FINANCIAL STATEMENTS

FOR THE QUARTERS ENDED MARCH 31, 2026 AND 2025

(Unaudited)

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, 2025, filed with SEC on April 15, 2026.

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 human surgical markets.

Developments

We are continuing on our path to seek FDA Premarket Approval (PMA) for our CelluSTAT Hemostatic Gauze products to implement our business strategy.  

In March 2024, we submitted a full application for Premarket Approval to the FDA. The FDA responded in June 2024 with a “Deficiencies Letter” listing 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.

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.

In October 2024, the Company and FDA conducted a virtual meeting to discuss the Deficiencies Letter and our follow-up questions. During the discussion, the Company noted the results of its 2019 clinical trial involving 232 patients (of whom 118 were treated with its hemostatic gauze) that showed statistically superior performance in time to hemostasis using CelluSTAT over Ethicon’s Surgicel Original, the standard of care. The study results also 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.

Notwithstanding the safety record from the original clinical study, the FDA requested more data to confirm the safety and effectiveness of CelluSTAT in surgical procedures in the intestinal and thoracic organ space, where the FDA was concerned that organ movement could 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 conducting a supplemental study, with patients undergoing open surgical procedures within the intestinal and thoracic organ space.

On October 25, 2024, we submitted our response to the FDA’s observations. On March 24, 2025, the FDA issued a Warning Letter that described five violations of applicable regulations that occurred during the planning and execution of the 2018-19 clinical study. These violations included: 1) failure to submit an IDE application to the FDA and failure to obtain FDA approval prior to beginning an investigation for which FDA’s approval is required, 2) failure to ensure proper monitoring of the investigation, 3) failure to monitor and ensure clinical investigators’ compliance with the study protocol and failure to terminate investigator’s participation in the study following non-compliance, 4) failure to immediately conduct an evaluation of any unanticipated adverse device effects and failure to report results of such an evaluation to the FDA and to the appropriate IRB, and 5) failure to maintain accurate, complete, and current device shipment and disposition records.

In response to the Warning Letter we conducted an analysis and investigation into root causes of these violations and developed Corrective and Preventative Actions (CAPAs) to address them, which we submitted to the FDA on April 14, 2025. In addition, we engaged an external monitor to review certain of the clinical data gathering during the clinical trial to report on the accuracy and reliability of the data, which we also submitted to the FDA in June and September 2025.

On December 10, 2025, the FDA issued a CAPA Assessment Letter that provided feedback on our response to the Warning Letter and our proposed CAPAs to address the violations that occurred during the 2019 study. In the letter, the FDA sought additional detail surrounding the Company’s 2018 correspondence with the WCG Institutional Review Board (IRB) regarding its approval of our clinical study, specifically relating to the FDA’s findings that the Company had modified certain FDA correspondence that it had presented to the IRB. In addition, FDA recommended that UHP conduct an audit of our processes, procedures and personnel (both internal and outside consultants) to ensure that the Company is able to ensure good clinical practices (GCP) when conducting a clinical study.

On January 5, 2026 we submitted to the FDA revised CAPAs and a proposal to conduct the recommended GCP Audit, and on February 16, 2026 submitted a report on our investigation of the 2018 IRB communications and a proposal for a third party monitor of our communications with the FDA and any IRB going forward to ensure the accuracy and regulatory compliance in these communications. On March 4, 2026 we held a Submission Issue Request (“SIR”) videoconference with the FDA to confirm their approval of our proposed collaboration with an established hemostatic device company wherein this company could serve as substitute Sponsor in a new pivotal IDE study of our CelluSTAT product, which the FDA did approve. On March 6, 2026, the FDA communicated their approval of the external audit firm that we had proposed on February 16 to conduct a GCP Audit of our procedures, process and personnel. This audit is expected to be completed by the end of July, 2026.

The timing to resolve the FDA Warning Letter is uncertain and we may not proceed with the clinical study requested by the FDA until its resolution. However, following consultation with the FDA, we are in discussions with potential corporate partners regarding a collaboration that would allow a partner to serve as substitute Sponsor of a CelluSTAT study, with UHP having an exclusive Rights to Reference to the study data for inclusion in a future PMA application. This plan would allow the study to be conducted concurrently with our ongoing efforts to resolve the Warning Letter, including the above mentioned GCP Audit.

There can be no assurance that we will reach an agreement with any party to serve as Sponsor of such a study or that our planned PMA application will be approved.

Financing with Alumni Capital

On December 16, 2025, the Company entered into a Securities Purchase Agreement with Alumni Capital LP (“Alumni”), pursuant to which Alumni provided a loan to the Company in the amount of $289,267 on a 15% original discount basis, evidenced by a senior convertible promissory note (the “Note”). The Company received net proceeds of $250,000. The Note bears no interest and matures on December 31, 2026. Subject to the terms of the Note, Alumni may convert the outstanding principal and accrued interest into shares of the Company’s common stock at a conversion price of $0.06039 per share. Alumni has agreed to limit its beneficial ownership of the Company’s common stock to less than 9.99% of the Company’s outstanding shares. In connection with the transaction, the Company entered into a registration rights agreement requiring the Company to register the resale of shares underlying the Note.

On the same date, the Company also entered into an Any Market Purchase Agreement (“AMPA”) with Alumni. Under the AMPA, the Company has the right, but not the obligation, to sell to Alumni up to an aggregate of $4,000,000 in value of the Company’s common stock from time to time through December 31, 2027, subject to the terms and conditions of the agreement. The purchase price of shares sold under the AMPA is based on a discount to the volume-weighted average price of the Company’s common stock over a specified trading period prior to each purchase notice. In connection with the AMPA, the Company issued Alumni a five-year warrant to purchase up to 3,484,321 shares of the Company’s common stock at an exercise price of $0.07462 per share.

On January 30, 2026, the Company registered the resale of shares of the Company’s common stock issuable under the Note and the AMPA on a Form S-1 registration statement. On May 12, 2026, the Company filed a post-effective amendment to the registration statement which was declared effective on May 14, 2026.

 Our CelluSTAT Gauze Products

CelluSTAT Hemostatic Gauze (formerly branded as HemoStyp) 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 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.

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:

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 described 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 develop and grow our revenue and profits in all target 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.

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:

Results of Operations for the three months ending March 31, 2026 and 2025

The following table sets forth a summary of certain key financial information for the three months ended March 31, 2026 and 2025:

Three Months ended March 31, 2026 versus Three Months ended March 31, 2025

Company had $0 of revenues during the three months ended March 31, 2026 and 2025. The Company did not generate any revenues in the current quarter due to the continued focus of the Company’s capital and resources towards obtaining a PMA.

Operating Expenses

Total operating expenses for the three months ended March 31, 2026 and 2025 were $265,581 and $1,489,216, respectively.

The decrease in operating expenses was primarily due to a decrease of $1,120,125 in stock-based compensation due to the vesting of 4,725,000 RSUs, a decrease in consulting expenses of $90,065, as the Company terminated the services of certain consultants, and a decrease in research and development expenses of $103,689, as the company purchased fewer external lab testing services, offset by an increase in legal services of $75,215 as the Company retained regulatory counsel to assist in correspondence with the FDA.

Other income (expense)

Other income (expense) for the three months ended March 31, 2026 and 2025 was $(50,261) and $(42,443), respectively. The increase in other expense was due to an increase in interest expense of $30,222 from the outstanding convertible notes and loan balances, offset by an increase in gain on derivative liabilities of $22,404.

Our net loss for the three months ended March 31, 2026 was $315,842 as compared to net loss of $1,531,659 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 $1,223,635 and an increase in other expense of $7,818, as explained above.

Financial Condition, Liquidity and Capital Resources

As of March 31, 2026, the Company had a negative working capital of $4,143,918. The Company has not yet attained a level of operations which will allow it to meet its current overhead expenses. The report of our independent registered public accounting firm on our 2025 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, capital markets conditions, competing medical device product developments and the overall regulatory environment.

As discussed in Note 6 of the financial statements, 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. The Company received approximately $3.3 million in proceeds from the sale of shares under the CSPA which the Company used to pay for its operations and advance its Class III PMA application. White Lion’s commitment under the CSPA expired in October 2025. On December 16, 2025 we entered into an Any Markets Purchase Agreement (“AMPA”) with Alumni Capital, LP, which requires Alumni Capital to purchase up to $4,000,000 of the Company’s common stock, subject to certain limitations and conditions set forth in the AMPA. The sale of additional equity or convertible debt securities would be dilutive to our shareholders.

Cash Flows

The Company’s cash on hand at March 31, 2026 and December 31, 2025 was $1,029 and $65,249, respectively.

The following table summarizes selected items from our statements of cash flows for the three months ended March 31, 2026 and 2025:

Net Cash Used in Operating Activities

Net cash used in operating activities for the three months ended March 31, 2026 was $84,339. The Company had a net loss of $315,842, amortization of right-of-use asset of $350, gain on derivative liabilities of $22,404, and an increase in prepaid and other current assets of $6,028 offset by amortization expense of $1,013, amortization of debt discount $9,276, and, an increase in accounts payable and accrued expenses of $179,240, an increase in accrued liabilities - related party of $24,556 and an increase in accrued compensation of $46,200.

Net cash used in operating activities for the three months ended March 31, 2025 was $273,969. The Company had a net loss of $1,531,659 offset by stock for services and compensation of $1,120,125, amortization expense of $1,013, amortization of right-of-use asset of $4, an increase in accounts payable and accrued expenses of $39,197, an increase in accrued liabilities - related party of $21,731 and an increase in accrued compensation of $82,988. The Company also had an increase prepaid and other current assets of $7,368.

Net Cash Used in Investing Activities

The Company did not have any investing activities during the three months ended March 31, 2026 and March 31, 2025.

 Net Cash Provided by Financing Activities

Net cash provided by financing activities for the three months ended March 31, 2026 was $20,119. This was due to the result of the Company receiving proceeds of $26,250 from notes payable offset by repayments of notes payable of $6,131. 

Net cash provided by financing activities for the three months ended March 31, 2025 was $110,000. This was due to the result of the Company receiving proceeds of $90,000 from convertible notes and a $20,000 advance from a related party. 

Off-Balance Sheet Arrangements

As of March 31, 2026, 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 2025 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.

 Warrants 

The Company accounts for common stock warrants in accordance with applicable accounting guidance provided in ASC 480 Distinguishing Liabilities from Equity and ASC 815 Derivatives and Hedging, as either derivative liabilities or as equity instruments depending on the specific terms of the warrant agreement. The warrants classified within equity are indexed to the Company’s common stock, provide for settlement in a fixed number of registered or unregistered shares for a fixed exercise price, and are freestanding equity instruments. Accordingly, they meet the criteria for equity classification under ASC 815-40 and are not subject to remeasurement in future periods. For warrants classified as equity instruments the Company applies the Black Scholes model and expenses the fair value as financing costs. For warrants classified as derivative financial instruments, the Company applies the Black Scholes model to value the warrants. 

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 March 31, 2026, 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 March 31, 2026, there were no changes in our system of internal controls over financial reporting.

PART II – OTHER INFORMATION

Item 1. Legal Proceedings

None.

Item 1A. Risk Factors

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, 2025. 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.

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

None.

Item 3. Defaults Upon Senior Securities

None.

Item 4. Mine Safety Disclosures

Not applicable.

Item 5. Other Information

During the quarter ended March 31, 2026, no director or officer of the Company adopted or terminated a “Rule 10b-1 trading arrangement” or “non-Rule 10b5-1 trading arrangement” as each term is defined in Item 408(a) of Regulation S-K.

Item 6. Exhibits

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

___________

* Filed herewith.

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.

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: