UNITEDSTATES

SECURITIESAND EXCHANGE COMMISSION

WASHINGTON,D.C. 20549

FORM10-K

☒Annual Report Pursuant to Section 13 or 15(d) of The SecuritiesExchange Act of 1934

ForThe Fiscal Year Ended May 31, 2025or

☐Transition Report Pursuant to Section 13 or 15(d) of The SecuritiesExchange Act of 1934

ForThe Transition Period From ______ To ______

CommissionFile Number: 001-37863

BIOMERICA,INC.

(ExactName of registrant as specified in its charter)

(949)645-2111

(Registrant’stelephone number, including area code)

Securitiesregistered under Section 12(b) of the Exchange Act:

Indicateby check mark if the registrant is a well-known seasoned issuer, as defined in Rule 405 of the Securities Act

Yes☐ No ☒

Indicateby check mark if the registrant is not required to file reports pursuant to Section 13 or Section 15(d) of the Securities Act.

Yes☐ No ☒

Indicateby check whether the registrant (1) filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subjectto such filing requirements for the past 90 days.

Yes☒ No ☐

Indicateby check mark whether the registrant has submitted electronically every Interactive Data File required to be submitted pursuant to Rule405 of Regulation S-T (§232.405of this chapter) during the preceding 12 months (or for such shorter period that the registrant wasrequired to submit such files).

Yes☒ No ☐

Indicateby check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, a smaller reportingcompany, or an emerging growth company. See the definitions of “large accelerated filer,” “accelerated filer,”“smaller reporting company,” and “emerging growth company” in Rule 12b-2 of the Exchange Act.

Ifan emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complyingwith any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐

Indicateby check mark whether the registrant has filed a report on and attestation to its management’s assessment of the effectivenessof its internal control over financial reporting under Section 404(b) of the Sarbanes-Oxley Act (15 U.S.C. 7262(b)) by the registeredpublic accounting firm that prepared or issued its audit report. ☐

Ifsecurities are registered pursuant to Section 12(b) of the Act, indicate by check mark whether the financial statements of the registrantincluded in the filing reflect the correction of an error to previously issued financial statements. ☐

Indicateby check mark whether any of those error corrections are restatements that required a recovery analysis of incentive-based compensationreceived by any of the registrant’s executive officers during the relevant recovery period pursuant to §240.10D-1(b). ☐

Indicateby check mark whether the Registrant is a shell company (as defined in Rule 12b-2 of the Act).

Yes☐ No ☒

Theaggregate market value of the registrant’s common stock held by non-affiliates, as of November 30, 2024, was approximately$6.4 million, based on the closing price of $3.12.The stock price and the number of shares takes into account a 1-for-8 reverse stock split which became effective on April 21, 2025(the “Reverse Stock Split”). 

Theoutstanding number of shares of common stock, par value $0.08,as of August 29, 2025 was 2,815,410.

DOCUMENTSINCORPORATED BY REFERENCE:

Portionsof the registrant’s definitive proxy statementrelating to its 2025 annual meeting of stockholders are incorporated by reference in Part III this Annual Report on Form 10-K where indicated.The definitive proxy statement will be filed with the U.S. Securities Exchange Commission within 120 days after the end of the fiscalyear to which this report relates.

CAUTIONARYNOTE REGARDING FORWARD LOOKING STATEMENTS

ThisAnnual Report on Form 10-K (“Form 10-K” or “Annual Report”) contains forward-looking statements within the meaningof the safe harbor provisions of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Actof 1934, as amended (the “Exchange Act”). All statements in this Annual Report, other than statements of historical facts,including, without limitation, statements regarding our strategy, future operations, future operating expenses, future financial position,future revenue, projected costs, prospects, plans, intentions, expectations, goals and objectives may be forward-looking statements.The forward-looking statements in this Annual Report do not constitute guarantees of future performance, and actual results could differmaterially from those expressed or implied in any forward-looking statements. In some cases, you can identify forward-looking statementsby words such as “believe,” “expect,” “anticipate,” “contemplate,” “estimate,”“project,” “forecast,” “would,” “may,” “should,” “will,” “could,”“can,” “potential,” “possible,” “proposed,” “plan,” “develop,”“opportunity,” “intend,” “initiative,” “target,” “maintain,” “continue,”“strive,” “progress,” “aim,” or the negative of these terms or other comparable expressions.

Factors,among others, that could cause actual results and events to differ materially from those expressed or implied in any forward-lookingstatement include:

Additionalfactors that might cause actual results and our current expectations and projections to differ materially include, among other things,those discussed under the section titled “Risk Factors,” as well as those discussed elsewhere in the Annual Report and theother risks detailed from time-to-time in our reports and registration statements filed with the Securities and Exchange Commission,or SEC. We intend that such forward-looking statements be subject to the safe harbors for such statements. These forward-looking statementsare based on the current beliefs and expectations of our management and speak only as of the date of this Annual Report or, in the caseof documents referred to or incorporated by reference, the date of those documents. You should not place undue reliance on these forward-lookingstatements, which are subject to significant known and unknown risks, uncertainties and other factors, which are in some cases, beyondour control and which could materially affect results. If underlying assumptions prove inaccurate or unknown risks or uncertainties materialize,actual results may differ materially from current expectations and projections.

Exceptas required by law, we do not undertake any obligation to revise or update publicly any forward-lookingstatements, whether as a result of new information, future events or otherwise. If we do update one or more forward-looking statements,no inference should be drawn that we will make additional updates with respect to those or other forward-looking statements.

Tableof Contents

PARTI

ITEM1. BUSINESS

BUSINESSOVERVIEW

THECOMPANY

Weare a global biomedical technology company that develops, patents, manufactures and markets advanced diagnostic and therapeutic products.Our diagnostic test kits are used to analyze blood, urine, nasal, or fecal material from patients in the diagnosis of various diseases,food intolerances, and other medical complications. They can also be used to measure or detect the presence and levels of specific bacteria,hormones, antibodies, antigens and other substances, which may exist in the human body in extremely small concentrations. Our productsare designed to enhance the health and well-being of people, while reducing total healthcare cost.

Ourextensive range of medical diagnostic products is sold worldwide, primarily in two markets: clinical laboratories and point-of-caresettings. Most of our products are Conformite Europeenne (“CE”) marked and/or registered with regulatory agencies in variouscountries for diagnostic use, with several also cleared by the U.S. Food and Drug Administration (“FDA”) for sale in theUnited States.

TECHNOLOGICALADVANCEMENTS AND PRODUCT DEVELOPMENT

Technologicaladvances in medical diagnostics have enabled diagnostic tests to be performed not only in clinical laboratories but also at home andat the point-of-care in physicians’ offices. One of our key objectives has been to develop and market rapid diagnostic tests thatare accurate, utilize easily obtained patient specimens, and are simple to perform without the need for complex instrumentation. Ourhome use (over-the-counter) and professional use (physicians’ office, clinics, etc.) rapid diagnostic test products help manageexisting medical conditions and may save lives through early detection and diagnosis of specific diseases. Traditionally, such testsrequired the expertise of medical technologists and sophisticated equipment, with results often not available for days. We believe ourrapid point-of-care tests, when properly used, can be as accurate as laboratory tests. Our products require limited to no instrumentation,deliver reliable results in minutes, and can be performed with confidence at home or in a physician’s office.

RESEARCHAND DEVELOPMENT

Weinvest resources in the research and development of new products designed to diagnose and, in some cases, treat several major medicaldiseases. These products are either internally developed or licensed from others. Our experienced and highly trained technical personnel,including Ph.D. holders and other scientists, are dedicated to developing new products and managing technology transfer activities. Ourtechnical staff, many of whom, have extensive experience from previous employment at large diagnostic manufacturing companies, bringa wealth of industry knowledge. Additionally, we rely on our Scientific Advisory Board, comprised of leading medical doctors and clinicians,to guide our clinical studies and product development efforts.

Forthe fiscal years ended May 31, 2025 and 2024, consolidated research and development expenses totaled approximately $1,023,000 and $1,491,000,respectively. The decrease reflects our transition from intensive product development to the commercialization phase of inFoods®IBS and hp+detect™, as well as our broader efforts to manage costs and preserve cash.

BeyondIBS, we are pursuing additional applications for the inFoods® technology for other disease states, including Functional Dyspepsia,Crohn’s Disease, Ulcerative Colitis, Gastroesophageal Reflux Disease (“GERD”), Migraine Headaches, Depression, andOsteoarthritis. We have filed patents globally to protect the use of inFoods® diagnostic technology for these indications, with patentsissued in the United States and multiple foreign jurisdictions, and others in review or prosecution.

Ourresearch and development efforts have also led to the FDA 510(k) clearance of hp+detect™, a proprietary diagnostic test for detectingHelicobacter pylori (H. pylori) and monitoring treatment. H. pylori is a leading cause of peptic ulcers and a significant risk factorfor gastric cancer. While commercialization activities for hp+detect™ are at an early stage, we continue to position the productas a reliable diagnostic option for laboratories and physicians.

KEYPRODUCT LAUNCHES

Akey outcome from our research and development efforts is our patented diagnostic-guided therapy (“DGT”) product, developedon the inFoods® technology platform. This innovative technology is designed to aid in the management of gastrointestinal conditionssuch as irritable bowel syndrome (“IBS”) and other inflammatory diseases. The DGT product targets chronic inflammatory illnessesthat are widespread and prevalent in large markets. We have launched inFoods® IBS product, which leverages this pateneted technology.The inFoods® IBS product utilizes a simple blood test to identify patient-specific foods that, when eliminated from the diet, mayhelp reduce IBS symptoms such as pain, bloating, diarrhea, cramping, and constipation. Unlike broad and difficult to manage dietary restrictions,the inFoods® IBS product pinpoints a patient’s heightened immunoreactivity to specific foods known to frequently trigger IBSsymptoms. By removing the foods identified as problematic, patients can achieve relief from IBS symptoms.

Wehave introduced our inFoods® product to gastroenterology (“GI”) physician groups in multiple states and regions,including collaboration with one of the largest GI groups in the U.S. The initial phase was focused on gathering real worldfeedback, optimizing physician engagement, and validating operational processes. GI physician feedback has been generally positive,and we are continuing to expand our presence in the GI segment while exploring opportunities to bring the inFoods® technology toother medical specialties. The outcome of our clinical study was published in the June 2025 issue of Gastroenteroloy. We are alsoassessing distribution, partnership, and licensing opportunities with large U.S. distributors to support broaderavailability and sale/marketing. We are actively pursuing insurance reimbursement for the InFoods IBS product in conjunction withour CLIA laboratory partner.

Aswe continue pursue commercial opportunities in both U.S. and international markets, we remain attentive to evolving global economic conditions,including uncertainties related to international trade policies, tariffs, and supply chain dynamics. Although these factors have nothad a material impact on our operations to date, future changes in trade regulations, tariff structures, or logistical constraints couldinfluence the cost, availability, or timing of materials and components used in our manufacturing processes. We continue to monitor thesedevelopments closely and are actively implementing contingency plans, including alternative sourcing strategies and supplier diversification,to support supply chain continuity, maintain operational efficiency, and help mitigate potential future impacts. We are also focusingon alternative manufacturing and shipping strategies of our products through our European subsidiary (BioEurope), and our Mexican subsidiary(BioMexico), to mitigate some of the risk these policies may have on our revenues and operations.

Inaddition, in December 2023 we received FDA clearance for hp+detect™, a diagnostic test designed to detect Helicobacter pylori (H.pylori) bacteria in the gastrointestinal tract. H. pylori is a prevalent infection, affecting approximately 35% of the U.S. populationand 45% of the population in Europe’s largest countries. This bacterium is recognized as the strongest known risk factor for gastriccancer, which remains one of the leading causes of cancer-related deaths globally. The hp+detect™ test is marketed directly tolaboratories and is intended to provide physicians and medical centers with a reliable tool for diagnosing H. pylori infections and monitoringtreatment effectiveness. We are currently  indiscussions with large end-customer laboratories for our hp+detect™ to position it for commercial adoption.

STRATEGICINITIATIVES AND COST MANAGEMENT

Aspart of our ongoing commitment to operational efficiency and disciplined capital management, we have taken proactive steps to optimizeour cost structure and extend our cash runway. These actions, which include a workforce reduction of approximately 15% during this fiscalyear, which incurred costs such as severance, impacting typical cost trends and margins. Additionally, we raised $2,015,000 in net proceedsfrom the ATM offering filed in May 2024  ,providing additional liquidity to support our operations. We are actively exploring strategic opportunities to enhance and create shareholdervalue.  

OPERATIONSAND GLOBAL PRESENCE

Biomericais headquartered in Irvine, California, where it centralizes administration, finance, regulatory compliance, product development, sales,marketing, customer service, and primary manufacturing operations. To enhance global competitiveness, the Company maintains manufacturingand assembly operations in Mexicali, Mexico, aiming to reduce production costs. Additionally, Biomerica operates BioEurope GmbH in Europe,facilitating the international sales of specific products.

Additionalinformation about Biomerica is available on our website at www.biomerica.com. The content on any website referred to in this Form 10-Kis not a part of or incorporated by reference in this Form 10-K unless expressly noted. Our Annual Report on Form 10-K, Quarterly Reportson Forms 10-Q, Current Reports on Forms 8-K, Proxy Statements and all other filings we make with the Securities and Exchange Commission(“SEC”) are available on our website, free of charge, as soon as reasonably practical after we file them with or furnishthem to the SEC and are also available online at the SEC’s website at www.sec.gov.

PRODUCTION

Ourdiagnostic test kits are manufactured and/or assembled at our facilities in Irvine, California, and in Mexicali, Mexico. We establishedour manufacturing facility in Mexicali, Mexico, in fiscal 2003 and moved a significant portion of our diagnostic packaging and assemblyto that facility.

Productionof diagnostic tests can involve formulating component antibodies and antigens in specified concentrations, attaching a tracer to theantigen, filling components into vials, packaging and labeling. We continually engage in quality control procedures to assure the consistencyand quality of our products and to comply with applicable FDA and international regulations.

Ourmanufacturing operations and facilities are regulated by the FDA Current Good Manufacturing Practices for medical devices. We have aninternal quality department that monitors and evaluates product quality and output. We also have an internal Quality Systems departmentwhose goal is to ensure that our operating procedures are in compliance with current FDA, CE Mark and International Organization forStandardization (“ISO”) regulations. We either produce our own antibodies and antigens or purchase these materials from qualifiedvendors. We have alternate, approved sources for most critical raw materials and are working to procure alternate sources for the fewthat we do not have.

MARKETSAND METHODS OF DISTRIBUTION

Biomericahas approximately 76 current customers for its diagnostic business, of which approximately 34 are foreign distributors, 4 are domesticdistributors and the balance are primarily domestic hospital and clinical laboratories, medical research institutions, medical schools,pharmaceutical companies, chain drugstores, wholesalers, physicians’ offices, and e-commerce customers.

Weemploy a director of sales and marketing for Europe and South America who is headquartered in Germany. She has over 20 years of experienceselling and marketing diagnostic and life science products across multiple diagnostics technologies and disciplines. She possesses broadinternational business experience, with communication skills in German, English, Spanish, French, and Portuguese, and scientific andtechnical understanding of gastrointestinal diagnostic products. She also has strong relationships with key strategic entities in Europe,Eastern Europe, Latin America, Canada, and the United States and we expect that she will continue to help us add new distributorsfor existing products and add new product-lines for future distribution by us.

Werely on distributors, advertising in medical and trade journals, exhibitions at trade shows, direct mailings,and an internal sales staff to market our diagnostic products. We target two main markets: (a) clinical laboratories and (b) point-of-caretesting (physicians’ offices and over-the-counter drug stores).

Ournet sales were approximately $5,311,000 for fiscal year ended May 31, 2025, compared to $5,415,000 for fiscal year ended May 31,2024. For the fiscal years ended May 31, 2025, and 2024, the Company had one distributor each year that accounted for 31%and 33% of our net sales, respectively.

Totalgross receivables were approximately $757,000 and $966,000 as of May 31, 2025 and 2024, respectively. As of those dates, four distributorsaccounted for approximately 69% and 64% of gross accounts receivable, respectively. Of the 69% concentration as of May 31, 2025, 27%was attributable to a distributor located in North America.

BACKLOG

Asof May 31, 2025, and 2024, Biomerica’s backlog of unshipped orders was approximately $1,324,000 and $755,000, respectively. Asof May 31, 2025, the majority of this backlog consisted of orders intended for shipment to Asia.

RAWMATERIALS

Biomericautilizes a range of principal raw materials including chemicals, serums, reagents, and packaging supplies. The majority of these materialsare sourced from multiple suppliers, ensuring we are not reliant on any single source. However, for certain critical materials such asantibodies, where suppliers are limited, there exists a risk of potential supply challenges or increased costs in the future.

Ourinventory includes antibodies, antigens, bottles, boxes, chemicals, and reagents essential for manufacturing our test kits, along withproducts in various stages of completion.

Forthe fiscal year ended May 31, 2025, purchases from one vendor accounted for approximately 12% of our total raw material procurement,primarily related to commodity plastic products. For the fiscal year ended May 31, 2024, purchases from one vendor accounted for approximately16% of our total raw material procurement, also primarily related to commodity plastic products.

COMPETITION

Weoffer several proprietary products with notable competitive advantages, including our EZ Detect colon disease home test, Aware BreastSelf-Exam product, inFoods^® IBS product, and hp+detect^™ for H. pylori detection. These products standout due to their unique features and benefits compared to competing tests in the market.

Ourcompetitors vary greatly in size. Many are divisions or subsidiaries of well-established medical and pharmaceutical companies which aremuch larger than Biomerica and expend substantially greater amounts than we do for research and development, manufacturing, advertising,and marketing.

Thecompetitive landscape for diagnostic products is shaped by several factors, including product uniqueness, technology, quality, performance,pricing, and service. Our competitive edge is grounded in the distinctiveness of our offerings, the high quality of our products, andtheir rapid test results. Our strong patent portfolio further bolsters our market position despite our limited marketing capabilities.

GOVERNMENTREGULATION OF OUR DIAGNOSTIC BUSINESS

Ourprimary business consists of selling products that are generally legally defined as medical devices and in vitro diagnostic medical devices.As a result, we are a medical devices and in vitro diagnostic medical devices manufacturer, and as such, we are subject to the regulationsissued and enforced by of numerous governmental entities. These agencies include the FDA, Environmental Protection Agency, Federal TradeCommission, Occupational Safety and Health Administration, U.S. Department of Agriculture (“USDA”), and Consumer ProductSafety Commission, as well as certain European Government agencies. Our activities are also regulated by various agencies of the statesand localities in which our products are sold. These regulations govern the introduction of new in vitro diagnostic medical devices andother medical devices, the observance of certain standards with respect to the manufacture and labeling of medical devices, the maintenanceof certain records, the reporting of potential product problems, and other related matters.

TheFood, Drug & Cosmetic Act of 1938 (the “FDCA”) regulates medical devices in the United States by classifying them intoone of three classes based on the extent of regulation believed necessary to ensure safety and effectiveness. Class I devices are thosedevices for which safety and effectiveness can reasonably be assured through general controls, such as device listing, adequate labeling,and adherence to the Quality Management System Regulation (“QMSR”) as well as Medical Device Reporting (“MDR”),labeling and other regulatory requirements. Some Class I medical devices are exempt from the requirement of Pre-Market Notification orclearance. Class II devices are those devices for which safety and effectiveness can reasonably be ensured through using special controls,such as performance standards, post-market surveillance and patient registries, as well as adherence to the general controls’ provisionsapplicable to Class I devices. Class III devices are devices that generally must receive clearance by the FDA pursuant to a pre-marketapproval prior to marketing to ensure their safety and effectiveness. Generally, Class III devices are limited to life-sustaining, life-supporting,or implantable devices. However, this classification can also apply to novel technology or new intended uses or applications for existingdevices. Our products are primarily either Class I or Class II medical devices.

Pursuantto FDA requirements, we have registered our manufacturing facility with the FDA as a medical device manufacturer and listed the medicaldevices we manufacture. We are also subject to inspection on a routine basis for compliance with FDA regulations. This includes the QualitySystem Regulation (“QSR”), which requires that we manufacture our products and maintain our documents in a prescribed mannerwith respect to issues such as design controls, manufacturing, testing, and validation activities. Further, we are required to complywith other FDA requirements with respect to labeling and MDR regulations which requires that we provide information to the FDA on deathsor serious injuries alleged to have been associated with the use of our products, as well as any product malfunctions that are likelyto cause or contribute to death or serious injury if the malfunction were to recur. We believe that we are currently in material compliancewith all relevant QSR and MDR requirements.

Inaddition, our facility is required to have a California Medical Device Manufacturing License. The license is not transferable and mustbe renewed biannually. Our current license is valid until November 19, 2026. Through compliance with FDA and California regulations,we can market some of our medical devices throughout the United States. International sales of medical devices are also subject to theregulatory requirements of each country where the product is sold. In Europe, the directives of the European Union (“EU”)require that a device has a CE Mark in order to be sold in EU countries. We comply with In Vitro Diagnostic Medical Devices Directive(“IVDD”) 98/79/EC, Medical Devices Regulation (EU) 2017/745 MDR and In Vitro Diagnostic Medical Devices Regulation (EU) 2017/746)(“IVDR”). We also comply with ISO 13485:2016 Medical Devices Quality Management Systems – Requirements for RegulatoryPurposes and EN ISO 14971:2019.

Atpresent, outside of the EU, the international regulatory review process varies from country to country. We work with our distributorsand sales representatives in the foreign countries in which we market our products to ensure that we comply with the regulatory lawsof those countries. We believe that our international sales to date have been in compliance with the laws of all foreign countries inwhich we have made sales. Exports of most medical devices are also subject to certain FDA regulatory controls.

Thedesigning, development, manufacturing, marketing, post-market surveillance, distribution, advertising, and labeling of our immunoassayin vitro diagnostic (“IVD”) medical device products are subject to regulation in the United States by the Center for Devicesand Radiological Health of the FDA and state agencies. FDA regulations require that some new products have pre-marketing clearance orapproval by the FDA and require these products to be manufactured in accordance with the FDA’s current Good Manufacturing Practice(“cGMP”) regulations, to be extensively tested and to be properly labeled to disclose test results and performance claimsand limitations. After a product that is subject to FDA regulation is placed on the market, numerous regulatory requirements apply, including,for example, the requirement that we comply with recordkeeping and reporting requirements, such as the FDA’s medical device reportingregulations and reporting of corrections and removals. The FDA enforces these requirements by inspection and post-market surveillance.The last FDA-announced inspection was in May 2024 and no observations were noted. We believe that all our products sold in the UnitedStates comply with the FDA and applicable state regulations.

Weare an FDA-regulated and ISO 13485:2016-certified In Vitro Diagnostic Medical Devices company. Our goal is to provide high quality medicaldiagnostic products that generally meet or exceed customer requirements and comply with all applicable regulatory requirements: FDA 21CFR Part 820 Quality Management System, ISO 13485:2016, Medical Devices Quality Management Systems – Requirements for RegulatoryPurposes, In Vitro Diagnostic Medical Devices Directive 98/79/EC, Medical Device Regulation (EU) 2017/745 and In Vitro Diagnostic MedicalDevices Regulation (EU) 2017/746) IVDR, Guidelines related to Medical Devices Directive/Regulation Guidance on CE Marking, among others.We involve our employees in a continuous improvement process to increase productivity, improve quality and maintain the suitability,adequacy, and effectiveness of our quality management system.

TheEU In Vitro Diagnostic Medical Device Regulation (“IVDR”EU) 2017/746 was effective on May 26, 2022.Manufacturers need to update their technical documentation and processes to meet the more stringent regulatory requirements of the EuropeanUnion. Notified Bodies can begin certifying devices to the new IVDR requirements once they have been designated under IVDR by their CompetentAuthority. Our Notified Body is officially designated under the IVDR and listed in the European Commission NANDO database since August19, 2021. We are working closely with our Notified Body to update our technical documentation to comply with these more stringent IVDRrequirements.

PerIVDR 2017/746 Amendment Regulation (EU) 2022/112, and published proposal 2024/0021 (COD), devices with a CE certificate that was issuedin accordance with IVDD may be placed on the market or put into service until December 31, 2027, providing a formal application to thenotified body has been made by May 26, 2025.

Inaccordance with the regulation, we submitted a formal application to the notified body by May 26, 2025.

PerIVDR 2017/746 Amendment Regulation (EU) 2022/112, and published proposal 2024/0021 (COD), devices without a CE certificate that was issuedin accordance with IVDD, for which a declaration of conformity was drawn up prior to May 26, 2022, per IVDD and for which the conformityassessment procedure pursuant to IVDR requires the involvement of a Notified Body, may be placed on the market, or put into service untilthe following dates. We also have until the following dates to update the technical documentation and processes to meet these regulatoryrequirements of IVDR 2017/746 providing a formal application to the notified body has been made:

SEASONALITYOF BUSINESS

Ourbusiness has not been subject to significant seasonal fluctuations.

INTERNATIONALBUSINESS

Thefollowing table sets forth the dollar volume of revenue attributable to sales to domestic customers and foreign customers during ourlast two fiscal years:

Ourinternational operations face distinct risks that differ from those encountered in the United States. These risks include economic fluctuations,regulatory changes, geopolitical instability (such as terrorism and trade disputes), tariffs, embargoes, import/export restrictions,and potential disruptions in shipping and distribution channels. Such factors can significantly impact our foreign sales and may complicateour ability to collect accounts receivable in international markets during economic downturns.

Eachcountry has its own licensing requirements for diagnostic products, which can differ considerably from U.S. regulations and may changeunexpectedly. Currently, our international sales rely on approximately 38 independent distributors across around 30 countries. Thesediverse factors contribute to the complexities and uncertainties associated with our international business operations.

INTELLECTUALPROPERTY

Weconsider the protection of our methodologies, designs, product formulations, manufacturing processes, diagnostic procedures, copyrights,service marks, trademarks, and trade secrets essential for our future success. To safeguard our proprietary rights in products and services,we utilize copyright, trademark, patent, service mark, and trade secret laws, alongside contractual restrictions. Our efforts includeconfidentiality and invention assignment agreements with employees and contractors, as well as nondisclosure agreements with most fulfilmentand strategic partners to restrict access to and disclosure of proprietary information. However, these measures may not entirely preventunauthorized use or disclosure of our technology.

Inthe past, we have licensed and may continue to license certain proprietary rights, such as trademarks, patents, trade secrets, or copyrightedmaterial, to third parties. While we strive to maintain the quality of our product brands through these license agreements, we cannotguarantee that licensees will always act in a manner that preserves the value of our proprietary rights or reputation.

LICENSEOF THIRD-PARTY INTELLECTUAL PROPERTY

Onoccasion, we in-licensed both exclusive and non-exclusive rights to intellectual property and patents owned by third parties. These licenseagreements typically require royalties and other payments.

Wehave a royalty agreement in which we obtained rights to manufacture and market an Adrenocorticotropic Hormone test (“ACTH test”) (used to detect chronic metabolic conditions).Royalty expenses of approximately $7,000 and $10,000, respectively, are included in cost of sales for this agreement for the fiscal yearsended May 31, 2025 and 2024. Sales of products manufactured under this agreement are not material to total sales for the fiscal yearsended May 31, 2025 and 2024, respectively. We may license other products or technology in the future as it is deemed necessary or opportunisticfor conducting business.

Someof the products that we manufacture, sell, or use may be covered by claims in issued patents held by other persons or entities, and assuch, upon notice from such persons or entity we may be required to pay a license fee or may be required to cease all manufacture, saleor use of such products, which could negatively impact us. While we have not been notified of any such claims by third parties, we cannotguarantee that such claims will not be made in the future.

BRANDSAND TRADEMARKS

Weoccasionally register our tradenames with the United States Patent and Trademark Office (“USPTO”). Of note, we registeredthe tradename “InFoods” on December 24, 2016. Our unregistered tradenames are “EZ Detect,” “EZ-H.P.,”and “EZ-PSA”. A trademark for “Aware” was issued and assigned in 2001, renewed in 2011 and 2021. On January 11,2020, the USPTO renewed our “FORTEL” trademark for another ten years.

Thelaws of some foreign countries do not protect our proprietary rights to the same extent as do the laws of the United States. Effectivecopyright, trademark, and trade secret protection may not be available in such jurisdictions.

PATENTSAND INFOODS TECHNOLOGY

Wehave filed dozens of international and Patent Corporation Treaty patents (“PCT”) and have multiple provisional and non-provisionalpatents currently filed with the USPTO. Substantially 15 of our patents that are pending or registered pertain to the inFoods^®technology platform.

Ourmost important family of patent applications pertains to our inFoods^® technology platform, which is a method of diagnosingand treating symptoms of many different inflammatory diseases. Our first product launch using this technology is the inFoods^®IBS product which is designed to diagnose and treat IBS. Using a patient blood sample, a physician or lab can run our test to identifyspecific foods (e.g., pork, milk, onions, sugar, chickpeas) that, if eliminated from an IBS patient’s diet, can alleviate or reducethe individual’s IBS symptoms, including, but not limited to, constipation, diarrhea, bloating, cramping, severe pain, and indigestion.We have filed many patent applications with the USPTO and with other such similar agencies in other countries outside of the United Statespertaining to this inFoods^® technology. These patent applications include claims that address the diagnosis and treatmentof several disease states including IBS, functional dyspepsia, Crohn’s disease, ulcerative colitis, gastroesophageal reflux disease,osteoarthritis, psoriasis, migraine headaches, and depression. The first inFoods^® patents filed by us pertained to IBS.Several of these patents pertaining to the inFoods^® IBS technology have been issued and many more are in active reviewand prosecution.

InAugust 2018, we received our first patent pertaining to the inFoods^® technology platform from the Korean IntellectualProperty Office, covering IBS. Since then, we have been granted a total of 15 patents. The USPTO has issued the Company two patentswith broad claims that protect our inFoods^® technology in testing and treating patients with IBS. Patents have alsobeen issued in the countries of Australia, Canada, Japan (two patents), Korea (two patents), Mexico, Panama, Peru, and Singapore,covering our inFoods^® IBS technology. Additional patent applications pertaining to the inFoods^® IBSproduct are in prosecution and review at the USPTO and with the patent issuance authorities in other countries.

Weare also developing and have filed patents with claims that cover products that target other diseases utilizing the inFoods^®technology platform. We have dozens of patents that are issued, in prosecution or review, pertaining to these other diseases, including:Functional Dyspepsia, Crohn’s disease, Ulcerative Colitis, GERD, Migraine Headaches, Depression, and Osteoarthritis. In addition,we have a family of patents that cover the use of certain information technology (“IT”) platforms and artificial intelligence/machinelearning (“AI/ML”) tools that could assist patients in identifying and avoiding packaged or processed food that contain specificfoods that they are trying to eliminate from their diet.

Inaddition to our inFoods IBS related issued patents, we have also been issued inFoods^® technology patents pertaining tothe following diseases in the following jurisdictions:

Webelieve the claims in these issued inFoods^® IBS patents and claims in our pending patents that protect the use of theinFoods^® technology to diagnose and treat various other diseases, provide us with broad protections from other companiesmaking or selling competing products in this highly disruptive new field of medicine.

Inaddition to the use of our own patents, we have been granted from third parties the rights to use, manufacture and sell certain productsthat are protected by patents or other intellectual property owned by these third parties. In some cases, royalties are paid on the salesof these products. We anticipate that we will license or purchase the rights to other products or technologies in the future.

Wealso engage in contract research and development and contract manufacturing for third party companies. The technologies that relate tothis contract research and development and manufacturing are protected by patents and other intellectual property. In these situations,this intellectual property is typically licensed to us under a limited license agreement enabling us to perform the services being contracted.

Withthe launch of inFoods^® IBS, our business model for this product includes the potential out-licensing of the product andrelated patents to a large international life sciences or technology company that could commercialize it or support us in its commercialization.Additionally, we may explore out-licensing opportunities for the patents or intellectual property associated with other products, includingour H. pylori product.

EMPLOYEES

Asof May 31, 2025 and 2024, we employed a total of 54 and 64 employees, respectively, in the United States, Mexico, UK and Germany, ofwhich 53 and 63 were full-time employees, respectively.

Weengage a range of external experts. including Ph.D.’s, M.D.’s, and other industry specialists, as well as medical institutions,to support various aspects of our operations. These services include technical support, regulatory guidance, marketing and public relations,financial advisory, and contract product development and manufacturing. To safeguard the Company, we implement confidentiality agreements,intellectual property ownership clauses, and indemnification provisions with these external parties. Despite these measures, we cannotguarantee complete protection against third-party claims or potential intellectual property theft.

CORPORATEHISTORY

Biomerica,Inc. is a Delaware corporation. The Company operates through two wholly owned subsidiaries: Biomerica de Mexico, which serves as an assemblyand manufacturing facility, and BioEurope GmbH, which functions as a distributor of the Company’s products in international markets.

ITEM1A. RISK FACTORS

Investingin our securities involves a high degree of risk. You should carefully consider the risks and uncertainties described below, togetherwith the other information in this Annual Report, including our consolidated financial statements and the related notes and “Management’sDiscussion and Analysis of Financial Condition and Results of Operations,” before deciding whether to invest in our securities.The occurrence of one or more of the events or circumstances described in these risk factors, alone or in combination with other eventsor circumstances, may have a material adverse effect on our business, reputation, revenue, financial condition, results of operations,and future prospects, in which event the market price of our Common Stock could decline, and you could lose part or all of your investment.The risks and uncertainties summarized above and described below are not intended to be exhaustive and are not the only ones we face.Additional risks and uncertainties not presently known to us or that we currently deem immaterial may also impair our business operations.This Annual Report also contains forward-looking statements that involve risks and uncertainties, refer to “Cautionary Note RegardingForward-Looking Statements.” Our actual results could differ materially and adversely from our anticipated results as a resultof a number of factors, including the risks described below. 

RISKSRELATED TO OUR BUSINESS

Wehave a history of operating losses.

Wehave a history of operating losses, and there is no guarantee that we will achieve profitability in the future. Our ability to generatenet profits and maintain positive cash flows is uncertain. Failure to achieve or sustain profitability could result in a decline in thevalue of our common stock and may necessitate seeking additional funding under potentially unfavorable conditions.

Althoughour financial statements have been prepared on a going concern basis, our current level of cash and cash equivalents available to usis not sufficient to meet our operating plans for the next 12 months, raising substantial doubt regarding our ability to continue asa going concern.

Ourfinancial statements as of May 31, 2025, have been prepared under the assumption that we will continue as a going concern for the nexttwelve months from the date of issuance. However, our independent registered public accounting firm has issued a report that includesan explanatory paragraph highlighting our operational losses and expressing substantial doubt about our ability to continue as a goingconcern for a period of at least the next twelve months from the date this report is filed.

Ourability to continue as a going concern depends on obtaining additional financing, achieving further operating efficiencies, increasingsales, reducing costs, and ultimately generating profitable operations. There is no assurance that we will be able to secure the necessarycapital on favorable terms, achieve sufficient revenue growth, or implement adequate cost reductions. Our financial statements do notreflect any adjustments that might result from the resolution of this uncertainty.

Ouroperating results may fluctuate adversely as a result of many factors that are outside our control, which may negatively impact our stockprice.

Ouroperating results are subject to fluctuations due to factors outside our control, which may adversely affect our business, financialcondition, and stock price. Key factors include:

Fluctuationsin our operating results, for any reason, could cause operating losses as a result of significant fixed expenses.

Webase the scope of our operations and related expenses on our estimates of future revenues. A significant portion of our operating expensesare fixed, and we may not be able to rapidly adjust our expenses if our revenues fall short of our expectations. Our revenue estimatesfor future periods are based, among other factors, on estimated end-user demand for our products. If end-user consumption is less thanestimated, revenues from our distribution partners and other distribution channels would be expected to fall short of expectations, andbecause such a significant portion of our costs are fixed, could result in operating losses.

Toremain competitive, we must continue to develop, obtain, and protect our proprietary technology rights; otherwise, we may lose marketshare or need to reduce prices as a result of competitors selling technologically superior products that compete with our products, orselling products at lower prices.

Ourability to compete successfully in the diagnostic market depends on continued development and introduction of new products, technology,and the improvement of existing technology. If we cannot continue to improve upon or develop, obtain, and protect our technology, ouroperating results could be adversely affected.

Toremain competitive, we must expend considerable resources to research new technologies and products and develop new markets, and thereis no assurance our efforts to develop new technologies, products, or markets will be successful or such technologies, products, or marketswill be commercially viable.

Wedevote a significant amount of financial and other resources to researching and developing new technologies, new products, and new markets.The development, manufacture and sale of diagnostic products require a significant investment of resources. The development of new productsand markets also requires a substantial investment of resources, such as new employees, offices and manufacturing facilities, consultants,and clinical trials. No assurances can be given that our efforts to develop new technologies or products will be successful, that suchtechnologies and products will be commercially viable, or our expansion into new markets will be profitable.

Thereis also no guarantee that our new products, including our inFoods^® IBS product and hp+detect^™, will bewell accepted into the marketplace.

Ouroperations will be adversely affected if our operating results do not correspondingly increase with our increased expenditures or ifour technology, product, and market development efforts are unsuccessful or delayed. Furthermore, our failure to successfully introducenew technologies or products and develop new markets could have a material adverse effect on our business and prospects.

TheCompany is required to obtain government or regulatory certification in many countries and the European community to sell its productsin those countries or regions. There is no assurance that the Company will be able to retain its certification in the future. This includesthe possibility and risk that the Company’s products do not meet the new EU IVDR testing and documentation requirements in thefuture as described in the above “Research and Development” section of this document.

Significantgovernment regulation exists in countries in which we conduct business. A large part of the Company’s sales is to distributorsin Europe, China, and other countries, which require us to maintain certain certifications to sell our products. Failure to comply withcurrent governmental regulations and quality assurance guidelines could cause the loss of these certifications, which could materiallyadversely affect the results of the Company. Loss of certifications could lead to temporary manufacturing shutdowns, product recalls,product shortages, or delays in product manufacturing and a decline in sales. Also, evolving EU IVDR requirements may increase compliancecosts and extend certification timelines, which could limit our ability to sell certain IVDD products in the EU.

TheCompany maintains a manufacturing plant in Mexico which presents risks to the Company including risks associated with doing businessoutside the United States.

Weoperate a significant manufacturing facility in Mexico through our subsidiary, Biomerica de Mexico. This international presence introducesa range of risks, including exposure to local economic and political conditions. Factors such as social unrest, potential terrorism,export and import restrictions, and fluctuations in currency exchange rates could impact our operations. Additionally, there is a riskof labor shortages, which could affect our manufacturing capabilities. These factors could lead to unforeseen costs and disruptions,materially impacting our business, financial results, and operational stability.

Weuse hazardous materials in our research and production that may result in unexpected and substantial claims against us relating to handling,storage, or disposal.

Ourresearch and production processes involve the use of hazardous materials, which presents inherent risks. Despite rigorous safety protocols,the possibility of accidental contamination or injury cannot be entirely eliminated. In the event of an accident, we could face significantliability for harm or damages, potentially exceeding our financial resources. Compliance with environmental regulations also entailssubstantial costs.

Ifgovernment authorities introduce new environmental regulations or change the interpretation of existing regulations, our operations couldbe further impacted. Such changes may impose additional costs, restrictions, or compliance requirements, which could hinder our research,development, or production efforts. Noncompliance with these regulations may result in significant fines, penalties, or damages, andcould necessitate costly remediation efforts. Furthermore, severe environmental or safety violations could lead to partial or total shutdownsof our research and manufacturing facilities, adversely affecting our business. The risk of contamination or injury from hazardous materialsmay also expose individuals to potential health hazards, resulting in fines or penalties that might not be covered by insurance, therebyimpacting our financial stability and operational continuity.

Werely on a limited number of key distributors that account for a substantial majority of our total revenue. The loss of any key distributoror an unsuccessful effort by us to directly distribute our products could lead to reduced sales.

Ournet sales were approximately $5,311,000 for fiscal year ended May 31, 2025, compared to $5,415,000 for fiscal year eneded May 31,2024. For the fiscal years ended May 31, 2025 and 2024, the Company had one distributor each year that accounted for 31% and 33% ofour net sales, respectively.

Totalgross receivables as of May 31, 2025, and 2024 were approximately $757,000 and $966,000, respectively. As of May 31, 2025 and 2024, theCompany had four distributors, respectively, that accounted for a total of 69% and 64% of gross accounts receivable, respectively. Ofthe 69% as of May 31, 2025, 27% was owed by a distributor in North America. Any adverse changes in our relationships with key distributors,or adverse issues related to their financial condition, performance, or purchasing patterns, could have a significant impact on our salesand overall financial results. The loss of a key distributor, or the failure of our direct distribution efforts, could further exacerbatethese challenges and adversely affect our business.

Weface risks relating to our international sales, including inherent economic, political, and regulatory risks, which could impact ourfinancial performance, cause interruptions in our current business operations and impede our growth strategy.

Weface risks relating to our international sales, including economic, political, and regulatory challenges, which could impact our financialperformance, disrupt our business operations, and hinder our growth strategy.

Asignificant amount of our products are sold internationally, with substantial sales to distributors in Asia and Europe. We rely on distributororganizations and sales agents to market and sell our products abroad, which exposes us to various foreign risks, including:

Mostof our international sales are negotiated and paid in U.S. dollars. However, currency risks remain, as fluctuations in foreign exchangerates can make our products comparatively more expensive. These exchange rate changes, along with general economic conditions in internationalmarkets, could negatively impact our sales. To maintain competitive pricing, we may need to offer discounts or reduce prices, leadingto lower margins on international sales. Continued changes in the values of the Euro, the Mexican peso, and other foreign currenciescould adversely affect our business, financial condition, and results of operations.

Wealso have supply agreements with foreign vendors that involve sharing foreign currency exchange fluctuation risks. We may enter intosimilar arrangements in the future.

Asignificant portion of our revenues comes from sales to our distribution partner in China. Political tensions between the U.S. and Chinacould disrupt or reduce our sales in the Chinese market, posing a substantial risk to our business.

Tariffsand trade dynamics may affect order timing.

Incertain markets, tariff changes and related trade uncertainties contributed to extended lead times and rescheduled shipments, which affectedthe timing of revenue recognition for certain international orders.

Ourresults of operations and financial conditions may be adversely affected by the financial soundness of our customers, distributors, andsuppliers.

Ouroperational results and financial condition are closely linked to the financial health of our customers, distributors, and suppliers.If any of these parties experience a deterioration in their financial performance or encounter difficulties with scheduled payments orcredit, it could have several adverse effects on our business.

Forinstance, if our customers are unable to pay or delay payment on accounts receivable, this would negatively impact our cash flow. Similarly,if our suppliers face financial challenges, they may restrict credit, impose more stringent payment terms, reduce or cease productionof essential components, or even stop operations entirely. Such disruptions could directly affect our ability to procure necessary materialsand maintain consistent product supply.

Moreover,reductions in reimbursements or purchase volumes from state and federal government programs, or private payers, could also occur dueto budget constraints or expenditure cuts. These reductions could adversely impact our revenues and cash flow, further straining ourfinancial performance.

Thecombined effect of these potential challenges could significantly influence our operating results and financial stability.

Weextend credit to customers outside the United States which can be difficult to collect.

Weextend credit to many of our customers, including those located outside the United States. Collecting receivables, particularly frominternational customers, can be challenging due to difficulties in obtaining reliable credit information and the complexities of enforcingcollections through foreign legal systems. If we are unable to effectively manage and collect on these receivables, especially from internationalcustomers, it could have a detrimental impact on our financial performance and liquidity.

Ifwe are not able to manage our growth strategy our operating results may be adversely affected.

Ourbusiness strategy contemplates further growth, including scaling up our operational systems and entering new geographical markets, includingthose outside the United States. This growth strategy could place additional demands on our limited employee and executive staff, potentiallydiverting their focus from core business activities. Furthermore, managing growth may strain our operational, financial, and managementinformation systems.

Expandinginto new markets or undertaking acquisitions introduces several risks, such as higher costs, unfamiliar market conditions, and integrationchallenges. Any difficulties in managing this growth or expanding effectively could adversely affect our operating results and financialperformance. The strain on management resources and potential inefficiencies in our systems could lead to operational and financial setbacks.

Theindustry and market segments in which we operate are highly competitive, and intense competition with other providers of diagnostic productsmay reduce our sales and margins.

Thediagnostic products industry and market segments in which we operate are highly competitive. Our diagnostic tests face competition fromsimilar products produced by numerous multinational and regional competitors who are heavily investing in competing technologies. Additionally,some of our distributors have developed, or may develop, their own products to compete directly with ours.

Manyof our competitors have substantial competitive advantages over us, including significantly greater financial, technical, and researchresources. They also possess larger, more established marketing, sales, distribution, and service networks; stronger relationships withhealthcare professionals; and extensive experience in research and development, manufacturing, clinical trials, and regulatory approvals.Furthermore, some competitors offer a broader range of products and enjoy greater brand recognition.

Ifour competitors’ products prove to be more effective or capture market share through superior marketing or competitive pricing,our sales and margins could suffer. This intense competition could materially and adversely affect our operating results.

Additionally,there has been a noticeable trend towards industry consolidation in recent years, with companies merging to strengthen or maintain theirmarket positions. This trend is expected to continue as companies strive to adapt to the evolving industry landscape. Competing successfullyin a consolidated industry may become increasingly challenging, and failure to do so could adversely impact our market position and financialperformance.

Intellectualproperty risks and third-party claims of infringement, misappropriation of proprietary rights, or other claims against us could adverselyaffect our ability to market our products, require us to redesign our products or attempt to seek licenses from third parties, resultin significant costs, and materially adversely affect our operating results.

Companiesin or related to our industry often aggressively protect and pursue their intellectual property rights. There are often intellectualproperty risks associated with developing and producing new products and entering new markets, and we may not be able to obtain, at reasonablecost or upon commercially reasonable terms, if at all, licenses to intellectual property of others that is alleged to be part of suchnew or existing products.

Werely on IP for the current products we sell and for the new products in research, development, and in clinical trials. While the Companytries to protect its IP with confidentiality agreements and internal policies, we still face risks that our IP will be stolen or otherwisemisappropriated, by parties inside or outside of the United States. Further, we have filed many patents around the world on much of theresearch and development done by the Company, and the proposed products to come from this research. The majority of these filed patentsare still under review and have not yet been allowed or issued. We may not be able to attain patent claims that adequately protect thecompany from competitors developing similar products or copying our products. Finally, there is a great number of issued patents ownedby others that pertain to the product categories in which we operate. While we do not know of any patents with claims that we are violatingby manufacturing or selling our current products, there is a risk that certain third-party patents will come to our attention that prohibitus from selling our products or that require us to pay royalty payments. Such third-party claims could have a material negative impacton the Company. Any of these IP-related risks could cause material damage to future revenues and to the long-term enterprise values ofthe Company.

Wehave hired and will continue to hire individuals or contractors who have experience in medical diagnostics and these individuals or contractorsmay have confidential trade secret or proprietary information of third parties. We cannot assure that these individuals or contractorswill not use this third-party information in connection with performing services for us or otherwise reveal this third-party informationto us. Thus, we could be sued for misappropriation of proprietary information and trade secrets. Such claims are expensive to defendand could divert our attention and result in substantial damage awards and injunctions that could have a material adverse effect on ourbusiness, financial condition, or results of operations. In addition, to the extent that individuals or contractors apply technical orscientific information independently developed by them to our projects, disputes may arise as to the proprietary rights to such dataand may result in litigation.

Thedefense and prosecution of patent and trade secret claims are both costly and time consuming. We or our customers may be sued by otherparties that claim that our products have infringed their patents or misappropriated their proprietary rights or that may seek to invalidateone or more of our patents. An adverse determination in any of these types of disputes could prevent us from manufacturing or sellingsome of our products, limit or restrict the type of work that employees involved with such products may perform for us, increase ourcosts, and expose us to significant liability. In addition, the defense of such claims could result in significant costs and divert theattention of our management and other key employees.

Inaddition to the foregoing, we may also be required to indemnify some customers, distributors, and strategic partners under our agreementswith such parties if a third party alleges or if a court finds that our products or activities have infringed upon, misappropriated,or misused another person’s proprietary rights. Further, our products may contain technology provided to us by other parties suchas contractors, suppliers, or customers. We may have little or no ability to determine in advance whether such technology infringes theintellectual property rights of a third party. Our contractors, suppliers, and licensors may not be required or financially able to indemnifyus in the event that a claim of infringement is asserted against us, or they may be required to indemnify us only up to a maximum amount,above which we would be responsible for any further costs or damages.

Someof the products that we manufacture, sell, or use may be covered by claims in issued patents held by other persons or entities, and assuch, upon notice from such persons or entity, we may be required to pay a license fee or may be required to cease all manufacture, saleor use of such products, which could negatively impact our financial results or operations. We cannot guarantee that such claims willnot be made in the future.

Weneed to continue to raise additional funds to finance our future capital or operating needs, which could have adverse consequences onour operations and the interests of our stockholders.

Althoughwe currently generate revenue, our company is operating at a loss due to significant commercialization of newly developed products andfrom a slow launch in revenues from our new products and some investments in research and development and. To sustain and advance ourbusiness strategy, we must continue to raise additional funds to meet our capital and operating needs. This often involves seeking publicor private debt or issuing equity. Raising funds through equity can dilute the interests of our existing stockholders.

Theavailability of capital, whether through debt or equity, is subject to fluctuations based on our financial condition and general marketor industry conditions. There may be periods when private capital markets or public debt and equity markets lack liquidity, or when weare unable to sell our securities at favorable prices. In such scenarios, accessing capital on favorable terms may become challenging.

Failureto secure adequate funding could force us to delay, reduce, or even eliminate certain development programs or commercialization efforts.The costs associated with development projects and regulatory approvals can be unpredictable and may exceed our initial estimates. Asour current operations are insufficient to cover these unexpected costs, this could adversely impact our ability to execute our businessstrategy and achieve our long-term goals.

Ourbusiness and products are highly regulated by various governmental agencies. Our results of operations would be negatively affected byfailures or delays in the receipt of regulatory approvals or clearances, the loss of previously received approvals, or other changesto the existing laws and regulations that adversely impact our ability to manufacture and market our products.

Thetesting, manufacturing, and sale of our products are subject to regulation by numerous governmental authorities in the United States,principally the FDA, and corresponding state and foreign regulatory agencies. Our future performance depends on, among other matters,if, when, and at what cost we will receive regulatory approval for new products, and if we can continue to comply with the many regulatoryrequirements that enable us to manufacture and sell medical related products and tests. Regulatory review can be a lengthy, expensive,and uncertain process, making the timing and costs of clearances and approvals difficult to predict. Meeting all regulatory requirements,laws and mandates, and maintaining compliance with such in order to manufacture and sell medical products can be difficult and expensive.Our results of operations would be negatively affected by failures or delays in the receipt of regulatory approvals or clearances, theloss of previously received approvals or clearances, the placement of limits on the marketing and use of our products, and restrictionson our ability to manufacture our products.

Changesin government policy could adversely affect our business and potential profitability.

Changesin government policy could have a significant impact on our business by increasing the cost of doing business, affecting our abilityto sell our products and negatively impacting our profitability. Such changes could include tariffs, embargos, trade wars, modificationsto existing legislation, such as U.S. tax policy, or entirely new legislation, such as the Affordable Healthcare Act in the United States.We cannot predict the many ways that healthcare reform in the United States and internationally, and changing trade legislation and policiescould adversely affect our business. It is unclear whether and to what extent, if at all, other anticipated developments, including changesdue to new presidential administration priorities, or changes resulting from healthcare reform, such as a change in the number of peoplewith health insurance, may impact us.

Weare subject to numerous government regulations in addition to FDA regulations, and compliance with laws, including changed or new laws,could increase our costs and adversely affect our operations. There is also the risk that our facilities could fail to get the properlicensing at our next inspection or renewal.

Inaddition to FDA and other regulations referred to above, numerous laws relating to such matters as safe working conditions, manufacturingpractices, data privacy, environmental protection, fire hazard control, and disposal of hazardous or potentially hazardous substancesimpact our business operations. If these laws or their interpretation change or new laws regulating any of our businesses are adopted,the costs of compliance with these laws could substantially increase our overall costs. Failure to comply with any laws, including lawsregulating the manufacture and marketing of our products, could result in substantial costs and loss of sales or customers. Because ofthe number and extent of the laws and regulations affecting our industry, and the number of governmental agencies whose actions couldaffect our operations, it is impossible to reliably predict the full nature and impact of future legislation or regulatory developmentsrelating to our industry and our products. To the extent the costs and procedures associated with meeting new or changing requirementsare substantial, our business, results of operations and financial condition could be adversely affected.

Ourtotal revenue could be affected by third-party reimbursement policies and potential cost constraints.

Theend-users of our products are physicians, labs, other healthcare providers and direct consumers. In the United States, healthcare providerssuch as hospitals and physicians who purchase diagnostic products generally rely on third-party payers, principally private health insuranceplans, federal Medicare, and state Medicaid, to reimburse all or part of the cost of the procedure. The growth needed in the sales ofour products would be adversely impacted if physicians and other healthcare providers do not receive adequate reimbursement for the costof our products by their patients’ third-party payers both in the United States and in foreign markets. Our total revenue couldalso be adversely affected by changes or trends in reimbursement policies of governmental or private healthcare payers. We believe thatthe overall escalating cost of medical products and services has led to, and will continue to lead to, increased pressures on the healthcareindustry, both foreign and domestic, to reduce the cost of products and services. Given the efforts to control and reduce healthcarecosts in recent years, currently available levels of reimbursement may not continue to be available in the future for our existing productsor products under development. Third-party reimbursement and coverage may not be available or adequate in either the United States orforeign markets, current reimbursement amounts may be decreased in the future and future legislation, regulation, or reimbursement policiesof third-party payers may reduce the demand for our products or adversely impact our ability to sell our products on a profitable basis.Finally, we are in the process of applying for Government payer reimbursement for our inFoods IBS® product in the US market. If weare unsuccessful in attaining reimbursement for this product, we will likely fall well short of our future revenue projections.

Unexpectedincreases in, or inability to meet, demand for our products could require us to spend considerable resources to meet the demand or harmour reputation and customer relationships if we are unable to meet demand.

Ourinability to meet customer demand for our products, whether as a result of manufacturing problems or supply shortfalls, could harm ourcustomer relationships and impair our reputation within the industry. In addition, our product manufacturing of certain product linesis concentrated in our two manufacturing sites. Weather, natural disasters (including pandemics), fires, terrorism, political change,governmental restrictions or stay-at-home orders in response to natural disasters (including pandemics), failure to follow specific internalprotocols and procedures, equipment malfunction, environmental factors, or damage to one or more of our facilities could adversely affectour ability to manufacture our products. This, in turn, could have a material adverse effect on our business.

Ifwe experience unexpected increases in the demand for our products, we may be required to expend additional capital resources or engagethird-party manufacturers to meet these demands. These capital resources could involve the cost of new machinery or even the cost ofnew manufacturing facilities. In addition, engaging third-party manufacturers would increase manufacturing costs and reduce margins.This would increase our capital costs or third-party expenses, which could adversely affect our earnings and cash resources. If we areunable to develop or obtain necessary manufacturing capabilities in a timely manner or to engage third-party manufacturers to meet demand,our total revenue could be adversely affected. Failure to cost-effectively increase production volumes, if required, or lower than anticipatedyields or production problems, including those encountered as a result of changes that we may make in our manufacturing processes tomeet increased demand or changes in applicable laws and regulations, could result in shipment delays as well as increased manufacturingcosts, which could also have a material adverse effect on our business, operating results and financial condition.

Unexpectedincreases in demand for our products could also require us to obtain additional raw materials in order to manufacture products to meetthe demand. Some raw materials require significant ordering lead time and we may not be able to timely access sufficient raw materialsin the event of an unexpected increase in demand, particularly those obtained from a sole supplier or a limited group of suppliers.

Ifone or more of our products is claimed to be defective or does not meet the performance criteria we claim in our marketing materials,we could be subject to product recalls, claims of liability, harm to patients or users of our products, or harm to our reputation thatcould adversely affect our business.

Aclaim of a defect in the design or manufacture of our products could have a material adverse effect on our reputation in the industryand subject us to claims of liability for injuries and otherwise. Further, a claim that one of our products is defective or does notactually meet the performance criteria we claim in our marketing materials, could require a product recall or otherwise have a substantialimpact on our revenues and financial performance. Any substantial underinsured loss resulting from such a claim or defect would havea material adverse effect on our operating results and financial conditions and the damage to our reputation or product lines in theindustry could have a material adverse effect on our business.

Weare exposed to business risks which, if not covered by insurance, could have an adverse effect on our results of operations. We facepotential product liability exposure, and, if claims brought against us are successful, we could incur substantial liabilities.

Weface a number of business risks, including exposure to product liability claims, employment law claims, claims that the Company or itsofficers, directors or employees have engaged in illegal or wrongful acts, claims of violation of environmental laws, and many otherpossible claims. Although we maintain insurance for a number of these risks, we may face claims for types of damages, or for amountsof damages, that are not covered by our insurance. For example, although we currently carry product liability insurance for liabilitylosses, there is a risk that product liability or other claims may exceed the amount of our insurance coverage or may be excluded fromcoverage under the terms of our policy. Also, our existing insurance may not be renewed at the same cost and level of coverage as currentlyin effect or may not be renewed at all. Further, we do not currently have insurance against many environmental risks we confront in ourbusiness. If we are held liable for a claim against which we are not insured or for damages exceeding the limits of our insurance coverage,that claim could have a material adverse effect on our results of operations.

Clinicaltrials involve a lengthy and expensive process with an uncertain outcome, and results of studies and trials may not be predictive offuture trial results.

Clinicaltrials are expensive, time consuming, and difficult to design and implement. Regulatory agencies may analyze or interpret the resultsdifferently than we do. Even if the results of our clinical trials are favorable, the clinical trials for a number of our product candidatesmay take a significant amount of time to complete. Regulatory authorities, including state and local authorities, may suspend, delayor terminate our clinical trials at any time, require us to conduct additional clinical trials, require a particular clinical trial tocontinue for a longer duration than originally planned, or require a change to our development plans such that we conduct clinical trialsfor a product candidate in a different order. There is no assurance that the results of the clinical trials will be positive. A negativeclinical trial could affect our ability to obtain regulatory clearances and/or potential licensing partners. There is also no assurancethat our clinical trials will not be delayed or will be completed. Any of the foregoing could have a material adverse effect on our business,results of operations and financial condition.

Wemay rely on third parties to conduct or be part of our clinical trials. If these third parties do not successfully carry out their contractualduties or meet expected deadlines, we may not be able to seek or obtain regulatory approval for or commercialize our product candidates.

Werely on third-party contract research organizations (“CROs”), universities or/clinical sites collectively, (“ClinicalResearch Partners”), to coordinate, monitor and conduct of our clinical trials and to manage, analyze, and interpret data for ourclinical programs. We, and our Clinical Research Partners, are required to comply with current Good Clinical Practices (“GCPs”),regulations, and guidelines issued by the FDA and by similar governmental authorities in other countries where we are conducting clinicaltrials. We have an ongoing obligation to monitor the activities conducted by our Clinical Research Partners and at our clinical sitesto confirm compliance with these requirements. In the future, if we, our Clinical Research Partnersor our clinical sites fail to complywith applicable GCPs, the clinical data generated in our clinical trials may be deemed unreliable and the FDA may require us to performadditional clinical trials before approving our marketing applications. If our Clinical Research Partners do not successfully carry outtheir contractual duties or obligations or meet expected deadlines, if they need to be replaced, or if the quality or accuracy of theclinical data they obtain is compromised due to their failure to adhere to our clinical protocols, regulatory requirements or for otherreasons, our clinical trials may be extended, delayed or terminated, and we may not be able to obtain regulatory approval for or successfullycommercialize our product candidates. As a result, our financial results and the commercial prospects for our product candidates wouldbe harmed, our costs could increase, and our ability to generate revenue could be delayed.

Failuresin our information technology and storage systems or data security breaches could significantly disrupt our business or force us to expendexcessive costs.

Failuresin our information technology and storage systems, many of which are outsourced to third parties, could significantly disrupt our businessand incur excessive costs.

Werely on complex information technology systems, many of which are outsourced to third-party providers, to support our business operationsand store critical information. Our dependence on these third parties means that we are reliant on their performance, security measures,and ability to meet our business needs. Any failures or disruptions in the services provided by these third-party vendors could resultin excessive costs or significant disruptions to our business operations.

Specifically,any disruptions, delays, or deficiencies caused by our enterprise resource planning system or other outsourced systems could negativelyimpact our ability to process orders, ship products, provide services and customer support, send invoices, track payments, fulfill contractualobligations, and maintain overall business operations.

Despiteour and our Clinical Research Partners’ implementation of security measures, information technology systems remain vulnerable todamage from various sources, including computer viruses, unauthorized access, telecommunications or network failures, malicious humanacts, terrorism, and natural disasters. Moreover, despite network security and backup measures, some of our servers and those of ourClinical Research Partners may still be susceptible to physical or electronic break-ins, computer viruses, and similar disruptive issues.Cybersecurity risks are escalating and pose significant threats to our operations. Cyber-attacks could result in the loss of vital companydocumentation and data, or confidential third-party documents held by the company, essential for our operations.

Despiteprecautionary measures to prevent unforeseen problems, sustained or repeated system failures that interrupt our ability to generate andmaintain data could materially disrupt our operations and lead to significant financial costs. Furthermore, any disruption or securitybreach resulting in data loss or damage, or inappropriate disclosure of confidential or proprietary information, could result in regulatoryactions, litigation, fines or penalties, adverse publicity, increased cybersecurity protection costs, and lost revenue.

Thereis also a risk that our measures and those of our third-party vendors to protect our systems from cyber-attacks may not be sufficientto prevent attacks by new sources and methods.

Ourbusiness could be negatively affected by the loss of or the inability to hire key personnel.

Ourfuture success is heavily dependent on our ability to retain key technical, sales, marketing, and executive personnel, as well as ourcapacity to identify and recruit additional qualified individuals. The competition for talent is intense, both within our industry andin the regions where we operate. As we anticipate growth in our operations, our need for additional management and other key personnelis expected to increase. Failure to retain our existing key personnel or to promptly identify and hire qualified replacements or additionalstaff to support our growth could have a detrimental impact on our business. Additionally, the loss of any key personnel, particularlyin research and development, could significantly harm our business, hinder our prospects, and obstruct the achievement of our research,operational, or strategic objectives.

Inresponse to the need to reduce ongoing operating costs, we have implemented a substantial reduction in our workforce. This reductionplaces an increased workload on the remaining employees and may create concerns about job security. These factors could lead to the lossof key employees, who are critical to our future success, and may make it difficult to attract and retain new talent in these roles.

Salesof our common stock in the public market could lower the market price for our common stock and adversely impact the trading price ofour securities.

Futuresales by the Company of a substantial number of shares of our common stock in the public market to raise needed capital, or the perceptionthat such sales may occur, could adversely affect the then prevailing market price of our common stock and could make it more difficultfor us to raise funds in the future through a public offering of our securities.

OnSeptember 28, 2023, we filed a “shelf” registration statement on Form S-3 with the SEC, allowing the Company to issue upto $20,000,000 in common shares. Under this registration statement, shares of our common stock may be sold from time to time for up tothree years from the filing date. On May 10, 2024, we filed a prospectus supplement with the SEC, as part of the registration statementfiled on September 28, 2023, which was declared effective on September 29, 2023. This supplement was intended to facilitate the saleof up to $5,500,000 in common stock through an At The Market (ATM) offerings, as defined in Rule 415 under the Securities Act.

Theissuance of additional shares of our common stock, or other securities, could dilute our existing stockholders’ ownership interests,potentially depress the market price of our common stock, and impair our ability to raise capital through future equity sales. The sizeand impact of future issuances on the market price of our common stock cannot be predicted.

Wealso have a number of stockholders who own large blocks of our common stock. If one or more of these stockholders were to sell largeportions of their holdings in a relatively short time, for liquidity or other reasons, the prevailing market price of shares of our commonstock could be negatively affected.

Inorder to attain needed capital to operate the Company, we may need to issue preferred stock, warrants, convertible debt or other financialinstruments that could have liquidation priority, requirements for interest or dividend payments, or other rights and that could be detrimentalto existing shareholders’ return on their investment in the Company.

Theprice of our stock may fluctuate unpredictably in response to factors unrelated to our operating performance.

Thestock market can experience significant price and volume fluctuations that are unrelated to the operating performance of individual companies.These broad market fluctuations may cause the market price of our common stock to drop. In particular, our common stock has historicallybeen volatile and may continue to be unpredictable in the future. Factors that could cause fluctuations in our stock price include, butare not limited to:

Additionally,due to the limited trading volume of our common stock, substantial sales of our stock could adversely impact its market price. Whileour common stock has been traded on the Nasdaq Capital Market since August 26, 2016, liquidity may be limited, and it could be challengingto liquidate large positions without adversely affecting the stock price.

Ourability to use our net operating loss carry forwards in the future may be subject to limitation.

Althoughwe have Federal income tax net operating loss carryforwards of approximately $28,378,000 and California state income tax net operatingloss carryforwards of approximately $26,921,000, as of May 31, 2025, use of these loss carryforwards will depend on future income inrelationship to expirations dates of these carryforwards.

ITEM1B. UNRESOLVED STAFF COMMENTS

None.

ITEM1C. CYBERSECURITY

Wehave implemented and maintain an information security program designed to identify, assess, and manage material risks from cybersecuritythreats to our critical computer networks, third party hosted services, communications systems, hardware and software, and our criticaldata including intellectual property, clinical trial participant and patient-related data, and confidential information that is proprietary,strategic or competitive in nature, or collectively, Information Systems and Data.

ITEM2. PROPERTIES

TheCompany leases its facilities. On May 31, 2025, the Company had approximately 22,000 square feet of floor space at its corporate headquartersat 17571 Von Karman Avenue in Irvine, California, 92614 which it has been leasing since 2009. This lease was scheduled to expire on August31, 2016, but the Company had an option to extend the term of its lease for two additional sixty-month periods. On November 30, 2015,the Company exercised its option to extend its lease for an additional sixty-month period and entered into the First Amendment to Leasewherein it extended its lease until August 31, 2021. On April 9, 2021, the Company exercised its second option to extend its lease foran additional five years. When the Company extended its lease in April 2021, it was also granted an additional five- year lease extensionoption. The current rent is approximately $28,000 per month and will increase on September 1, 2025, to $28,500 per month. The securitydeposit is approximately $22,000.

InNovember 2016, the Company’s Mexican subsidiary, Biomerica de Mexico, entered into a 10-year lease for approximately 8,100 squarefeet of manufacturing space located in Mexicali, Mexico. The Company has one 10-year option to renew at the end of the initial leaseperiod. The current rent is approximately $3,100 per month. Biomerica de Mexico also leases a smaller unit on a month-to-month basisfor use in one manufacturing process. In addition, the Company leases a small office in Lindau, Germany on a month-to-month basis, asheadquarters for BioEurope GmbH, its Germany subsidiary.

Webelieve our space is adequate for our current needs.

ITEM3. LEGAL PROCEEDINGS

Fromtime to time, the Company is involved in legal proceedings, claims, and litigation arising in the ordinary course of business, whichmay impact its financial results.

Asof May 31, 2025, there were no pending legal proceedings. However, the outcome of any future legal matters, claims, or litigation couldpotentially have a material adverse effect on the Company’s quarterly or annual operating results or cash flows when resolved insubsequent periods. Nonetheless, based on current information, management believes these matters will not have a material adverse effecton the Company’s consolidated financial position, results of operations, or cash flows.

ITEM4. MINE SAFETY DISCLOSURES

Notapplicable.

PARTII

ITEM5. MARKET FOR COMMON EQUITY AND RELATED STOCKHOLDER MATTERS AND ISSUER PURCHASES OF EQUITY SECURITIES

MarketInformation

Our common stock is listedfor trading on the Nasdaq Capital Market stock exchange under the symbol BMRA.

Holders

Asof August 29, 2025, the number of holders of record of Biomerica’s common stock was approximately 858, excluding stock held instreet name. The number of record holders does not bear any relationship to the number of beneficial owners of the common stock as mostof the Company’s common stock is held in street name at securities brokerage firms.

Dividends

TheCompany has not paid any cash dividends on its common stock in the past and does not plan to pay any cash dividends on its common stockin the foreseeable future. The Company intends, for the foreseeable future, to retain any earnings to finance the continued operationand expansion of the Company’s business.

PerformanceGraph

Weare a smaller reporting company, as defined by Rule 12b-2 of the Exchange Act and are not required to provide the information requiredunder this item.

RecentSales of Unregistered Securities

None.

Purchasesof Equity Securities by the Issuer and Affiliated Purchasers

Wedid not purchase any of our shares of common stock or other securities during our fiscal year ended May 31, 2025.

ITEM6. RESERVED

Notrequired.

ITEM 7. MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS

Youshould read the following discussion and analysis of our financial condition and results of operations in conjunction with our consolidatedfinancial statements and the accompanying notes thereto included elsewhere in this Annual Report on Form 10-K. This discussion and analysiscontains forward-looking statements that are based on our management team’s expectations, beliefs, intentions, strategies, estimatesand assumptions, which statements are subject to substantial risks and uncertainties. Our actual results may differ materially from thoseexpressed or implied by these forward-looking statements as a result of many factors, including those discussed in the sections titled“Cautionary Note Regarding Forward-Looking Statements” and “Risk Factors” appearing elsewhere in this AnnualReport on Form 10-K.

OVERVIEW

Weare a global biomedical technology company that develops, patents, manufactures and markets advanced diagnostic and therapeutic products.Our diagnostic test kits are used to analyze blood, urine, nasal, or fecal material from patients in the diagnosis of various diseases,food intolerances, and other medical complications. They can also be used to measure or detect the presence and levels of specific bacteria,hormones, antibodies, antigens and other substances, which may exist in the human body in extremely small concentrations. Our productsare designed to enhance the health and well-being of people, while reducing total healthcare cost.

Ourextensive range of medical diagnostic products is sold worldwide, primarily in two markets: clinical laboratories and point-of-care settings.Most of our products are Conformite Europeenne (“CE”) marked and/or registered with regulatory agencies in various countriesfor diagnostic use, with several also cleared by the U.S. Food and Drug Administration (“FDA”) for sale in the United States.

Technologicaladvances in medical diagnostics have enabled diagnostic tests to be performed not only in clinical laboratories but also at home andat the point-of-care in physicians’ offices. One of our key objectives has been to develop and market rapid diagnostic tests thatare accurate, utilize easily obtained patient specimens, and are simple to perform without the need for complex instrumentation. Ourhome use (over-the-counter) and professional use (physicians’ office, clinics, etc.) rapid diagnostic test products help manageexisting medical conditions and may save lives through early detection and diagnosis of specific diseases. Traditionally, such testsrequired the expertise of medical technologists and sophisticated equipment, with results often not available for days. We believe ourrapid point-of-care tests, when properly used, can be as accurate as laboratory tests. Our products require limited to no instrumentation,deliver reliable results in minutes, and can be performed with confidence at home or in a physician’s office.

Weinvest resources in the research and development of new products designed to diagnose and, in some cases, treat several major medicaldiseases. These products are either internally developed or licensed from others. Our experienced and highly trained technical personnel,including Ph.D. holders and other scientists, are dedicated to developing new products and managing technology transfer activities. Ourtechnical staff, many of whom, have extensive experience from previous employment at large diagnostic manufacturing companies, bringa wealth of industry knowledge. Additionally, we rely on our Scientific Advisory Board, comprised of leading medical doctors and clinicians,to guide our clinical studies and product development efforts.

Akey outcome from our research and development efforts is our patented diagnostic-guided therapy (“DGT”) product, developedon the inFoods® technology platform. This innovative technology is designed to aid in the management of gastrointestinal conditionssuch as irritable bowel syndrome (“IBS”) and other inflammatory diseases. The DGT product targets chronic inflammatory illnessesthat are widespread and prevalent in large markets. We have launched inFoods® IBS product, which leverages this patented technology.The inFoods® IBS product utilizes a simple blood test to identify patient-specific foods that, when eliminated from the diet, mayhelp reduce IBS symptoms such as pain, bloating, diarrhea, cramping, and constipation. Unlike broad and difficult to manage dietary restrictions,the inFoods® IBS product pinpoints a patient’s heightened immunoreactivity to specific foods known to frequently trigger IBSsymptoms. By removing the foods identified as problematic, patients can achieve relief from IBS symptoms.

Wehave introduced our inFoods® product to select gastroenterology (“GI”) physician groups in multiple states and regions,including collaboration with one of the largest GI groups in the U.S. This initial phase was focused on gathering real-world feedback,optimizing physician engagement, and validating operational processes. GI physician feedback has been generally positive, and we arecontinuing to expand our network by onboarding additional physician practices.

Ourdedicated sales team is focused on building strong relationships within the GI segment while selectively exploring opportunities to introduceinFoods® to other medical specialties, including integrated health practices and primary-care providers. These efforts are intendedto lay the groundwork for broader adoption by showcasing the distinct clinical value of inFoods® across multiple healthcare channels.

Concurrently,we are evaluating distribution, partnership, and licensing opportunities with U.S. companies to support a scalable, broad market launch.These potential collaborations could significantly enhance the commercialization trajectory of inFoods® products, both domesticallyand internationally.

Weare currently in the process of applying for US government payment or reimbursement for the inFoods IBS product through the Medicaresystem. If the Company is successful in attaining reimbursement, we will move forward with applying for reimbursement of this productby private payer insurance companies. If patients are able to attain and use our inFoods IBS® product at no cost, or with a smallco-payment, we believe this will dramatically increase our revenues from this product.

Aswe continue pursue commercial opportunities in both U.S. and international markets, we remain attentive to evolving global economic conditions,including uncertainties related to international trade policies, tariffs, and supply chain dynamics. Although these factors have nothad a material impact on our operations to date, future changes in trade regulations, tariff structures, or logistical constraints couldinfluence the cost, availability, or timing of materials and components used in our manufacturing processes. We continue to monitor thesedevelopments closely and are actively implementing contingency plans, including alternative sourcing strategies and supplier diversification,to support supply chain continuity, maintain operational efficiency, and help mitigate potential future impacts. We are also focusingon alternative manufacturing and shipping strategies of our products through our European subsidiary (BioEurope), and our Mexican subsidiary(BioMexico), to mitigate some of the risk these policies may have on our revenues and operations.

Inaddition, in December 2023 we received FDA clearance for hp+detect™, a diagnostic test designed to detect Helicobacter pylori (H.pylori) bacteria in the gastrointestinal tract. H. pylori is a prevalent infection, affecting approximately 35% of the U.S. populationand 45% of the population in Europe’s largest countries. This bacterium is recognized as the strongest known risk factor for gastriccancer, which remains one of the leading causes of cancer-related deaths globally. The hp+detect™ test is marketed directly tolaboratories and is intended to provide physicians and medical centers with a reliable tool for diagnosing H. pylori infections and monitoringtreatment effectiveness. We are actively promoting hp+detect™ to large end-customer laboratories and positioning the product forcommercial adoption.

Dueto the slower-than-expected launch of our key products, inFoods^® IBS and hp+detect^™, we have initiatedsignificant cost-cutting measures to extend our cash runway and work towards increasing revenues to cover overhead costs. These measuresinclude a workforce reduction of nearly 15% during this fiscal year, which incurred costs such as severance, impacting typical cost trendsand margins. Additionally, we raised $2,015,000 in net proceeds from the ATM offering filed in May 2024 providing additional liquidityto support our operations. We are actively exploring strategic opportunities to enhance and create shareholder value.

ReverseStock Split

EffectiveApril 21, 2025 (the “Effective Date”), we filed a Certificate of Amendment to our Second Amended and Restated Certificateof Incorporation with the Secretary of State of the State of Delaware, to effect a 1-for-8 reverse stock split (the “Reverse StockSplit”) of our Common Stock. Beginning with the opening of trading on the Effective Date, our common stock began trading on Nasdaqon a split-adjusted basis under the same symbol, “BMRA.” As a result of the Reverse Stock Split, every 8 shares of our commonstock issued and outstanding were automatically combined and converted into 1 validly issued, fully paid and non-assessable share ofcommon stock. In lieu of any fractional shares, stockholders who would otherwise have been entitled to receive a fractional share insteadhad their interests automatically rounded up to the next whole share, after aggregating all the fractional interests of a holder resultingfrom the Reverse Stock Split.

TheReverse Stock Split did not change the number of authorized shares of our common stock or preferred stock as set forth in our Certificateof Incorporation, as amended. All historical share and per share data for the periods presented in our consolidated financial statements,including for periods ending prior to the Effective Date, has been adjusted to reflect the 1-for-8 Reverse Stock Split on a retroactivebasis as if the Reverse Stock Split occurred as of the earliest period presented. 

RESULTSOF OPERATIONS

NetSales and Cost of Sales

Thefollowing is a breakdown of revenues according to markets to which the products are sold:

Forthe fiscal year ended May 31, 2025, our net sales were approximately $5,311,000, representing a decrease of $104,000, or 2%, comparedto $5,415,000 for the fiscal year ended May 31, 2024. The decrease was primarily driven by reduced retail market activity, lower internationalover-the-counter sales due to potential tariff impacts, and volatility in clinical laboratory demand. These declines were partially offsetby higher contract manufacturing billings and increased demand for our inFoods® IBS product.

Consolidatedcost of sales for the fiscal year ended May 31, 2025 was approximately $4,813,000, or 91% of net sales, compared to $4,804,000, or 89%of net sales, for the fiscal year ended May 31, 2024, reflecting a slight increase of $9,000, or 0.2%. The increase was primarily attributableto higher contract manufacturing costs, driven by increased sales in this category, as well as higher costs associated with our inFoods®product. These increases were partially offset by a reduction in direct labor costs. The overall margin impact also reflected a shiftin sales mix, with lower over-the-counter sales, which typically generate higher margins in the retail market.

OperatingExpenses

Thefollowing is a summary of operating expenses:

Selling,General and Administrative Expenses

Ourselling, general, and administrative expenses were approximately $4,612,000 for the fiscal year ended May 31, 2025, compared to $5,487,000for the fiscal year ended May 31, 2024, a decrease of $875,000, or 16%. This reduction reflects our strategic financial management andwas primarily attributable to a $351,000 decrease in payroll expenses following a reduction in force implemented in July 2024, a $327,000decrease in stock compensation, a $66,000 decrease in marketing expenses for OTC products, and a $59,000 decrease in sales and marketingoutside services. Overall, the decrease in SG&A expenses demonstrates our continued commitment to strategically allocating capitaland maintaining financial discipline while pursuing growth opportunities.

Researchand Development

Ourresearch and development expenses were approximately $1,023,000 for the fiscal year ended May 31, 2025, compared to $1,491,000 for thefiscal year ended May 31, 2024, a decrease of $468,000, or 31%. The decrease was primarily driven by a $311,000 reduction in payrollexpenses following a reduction in force implemented in July 2024, $68,000 in cost saving related to our inFoods® research and developmentprojects, and a $33,000 reduction in research and development hp+detect™ project expenses as the research phase was completed.For a detailed discussion of our ongoing research initiatives and their potential market impacts, please refer to the “Researchand Development” section in Item 1.  

Dividendand Interest income

Dividendand interest income was approximately $165,000 for the fiscal year ended May 31, 2025, compared to $431,000 for the fiscal year endedMay 31, 2024. The decrease of $266,000 was primarily attributable to lower market interest rates on our cash and cash equivalents, aswell as a reduction in cash and cash equivalent balances.

LIQUIDITY,CAPITAL RESOURCES AND GOING CONCERN

Thefollowing are the principal sources of liquidity:

TheCompany’s ability to continue as a going concern over the next twelve months is influenced by several factors, including:

Managementhas analyzed the Company’s cash flow requirements through August 2026 and beyond. Based on this analysis, we believe our currentcash and cash equivalents are insufficient to meet our operating cash requirements and strategic growth objectives for the next twelvemonths.

Toaddress our capital needs and sustain operations beyond the next year, we are actively pursuing strategies to increase sales, reduceexpenses, sell non-core assets, seek additional financing through debt or equity, and seek other strategic alternatives.

Aspart of our efforts to reduce costs, we have initiated significant cost-cutting measures to extend our cash runway and work towards increasingrevenues to cover overhead costs. These measures include a workforce reduction of nearly 16% and a substantial reduction in other operatingexpenses.

Aspart of our financing plan, on September 28, 2023, we filed a “shelf” registration statement on Form S-3 with the SEC, whichwas declared effective on September 29, 2023, allowing the Company to issue up to $20,000,000 in shares of our common stock. Under thisregistration statement, shares of our common stock may be sold from time to time for up to three years from the filing date. On May 10,2024, the Company filed a prospectus supplement with the SEC, as part of this registration statement. This prospectus supplement wasintended to facilitate the sale of up to $5,500,000 in common stock through ATM offerings, as defined in Rule 415 under the SecuritiesAct. As part of this transaction, the Company incurred $81,000 in deferred offering costs during the year ended May 31, 2024. Duringthe year ended May 31, 2025, the Company sold 440,687 shares of its common stock at prices ranging from $3.06 to $8.32 pursuant to theATM Agreement, which resulted in gross proceeds of approximately $2,143,000 and net proceeds to the Company of $2,015,000, after deductingcommissions for each sale and legal, accounting, and other fees related to offering in the amount of $128,000.

TheCompany intends to use the net proceeds from this offering for general corporate purposes, including, but not limited to, sales and marketingactivities, clinical studies and product development, acquisitions of assets, businesses, companies, or securities, capital expenditures,and working capital needs.

Whilewe are committed to these plans, there is no assurance that these efforts will be successful or sufficient to meet our capital requirements.

Thesefactors raise substantial doubt about the Company’s ability to continue as a going concern. Our future viability depends on thesuccessful execution of our strategic plans, securing additional financing, and achieving profitable operations.

Inaddition, our business is subject to additional risks and uncertainties, including, but not limited to, those described in Item 1A. “RiskFactors”.

OperatingActivities

Duringthe fiscal year ended May 31, 2025, cash used in operating activities was approximately $3,841,000 compared to $5,361,000 for the fiscalyear ended May 31, 2024. The primary factors contributing to this were a loss of approximately $4,973,000, an increase in inventory reservesof $4,000, an increase in accounts receivable of $209,000, a decrease in inventories of $882,000 and a non-cash expense of approximately$944,000. These were partially offset by a decrease in accounts payable and accrued expenses of $467,000, and reduction in lease liabilitiesof $326,000.

Duringthe fiscal year ended May 31, 2024, cash used in operating activities was approximately $5,361,000, compared to $5,474,000 for the fiscalyear ended May 31, 2023. The primary factors contributing to this were a loss of approximately $5,978,000, a decrease in inventory reservesof $205,000, an increase in accounts receivable of $215,000, an increase in inventories of $115,000 and a decrease in lease liabilityof $297,000. These were partially offset by an increase in accounts payable and accrued expenses of $246,000, and non-cash expenses ofapproximately $1,211,000.

InvestingActivities

Duringthe fiscal year ended May 31, 2025, cash used in investing activities was approximately $37,000, as compared to $115,000 for the fiscalyear ended May 31, 2024. During the fiscal year ended May 31, 2025, we had $37,000 in expenditures related to patents. Duringthe fiscal year ended May 31, 2024, we purchased approximately $51,000 of property and equipment and had $64,000 in expenditures relatedto patents.

FinancingActivities

Cashprovided financing activities was approximately $2,111,000 for the fiscal year ended May 31, 2025, compared to cash used in financingactivities of $81,000 in the fiscal year ended May 31, 2024. In fiscal year end May 31, 2025, we received net proceeds of $2,015,000from the sale of our common stock and $15,000 from the exercise of stock options. In addition, the Company recorded a non-cash reclassificationof $84,000 in deferred offering costs during the same period. By contrast, in the fiscal year ended May 31, 2024, our financing activitiesprimarily consisted of $81,000 in payments for deferred offering costs.

Duringthe fiscal years ended May 31, 2025 and 2024, we received approximately $2,015,000 and $0, respectively, in net proceeds from the saleof common stock. Our common stock sold and issued in the fiscal year ended May 31, 2025 was issued under our shelf registration statementfiled with the SEC on September 28, 2023, which was declared effective on September 29, 2023 (the “2023 Registration Statement”).On May 10, 2024, the Company filed a prospectus supplement to the 2023 Registration Statement with the SEC for the sale of up to $5,500,000in common stock through ATM offerings, as defined in Rule 415 under the Securities Act. As part of this transaction, the Company incurred$81,000 in deferred offering costs during the fiscal year ended May 31, 2024. 

Asof August 29, 2025, the date on which this Annual Report on Form 10-K for the fiscal year ended May 31, 2025, is filed with the SEC,our 2023 Registration Statement remains subject to the offering limits set forth in General Instruction I.B.6 of Form S-3 becauseour public float is less than $75 million. For so long as the Company’s public float is less than $75 million, the aggregatemarket value of securities sold by the Company under the 2023 Shelf Registration Statement pursuant to Instruction I.B.6 to Form S-3during any 12 consecutive months may not exceed one-third of the Company’s public float. For purposes of this limitation, the aggregate market value of our outstanding common stock held by non-affiliates, orpublic float, was $9,945,252, based on 2,402,235 non-restricted shares of our outstanding common stock held by non-affiliates and aprice of $4.14 per share, which was the price at which our common stock was last sold on the Nasdaq Capital Market on July 24,2025 (a date within 60 days of the date hereof), calculated in accordance with General Instruction I.B.6 of Form S-3. After givingeffect to the $3,315,084 offering limit imposed by General Instruction I.B.6 of Form S-3, and after deducting the shares we sold within thepreceding 12 months, as of the date of filing this Annual Report, we may sell $231,986 shares of our common stock at this time under the2023 Shelf Registration Statement.

SUBSEQUENTEVENTS

OnJuly 21, 2025, the Company received a cash refund of approximately $1.1 million from the Internal Revenue Service (IRS) related to previouslyfiled claims for the Employee Retention Credit (ERC), a refundable payroll tax credit under the Coronavirus Aid, Relief, and EconomicSecurity (CARES) Act. This amount was recorded and collected subsequent to year-end.

InJuly and August 2025, the Company completed sales of its common stock under its At-the-Market (“ATM”) offering program, generatingnet proceeds of approximately $919,000 subsequent to year-end.

OFFBALANCE SHEET ITEMS

Therewere no off-balance sheet arrangements as of May 31, 2025.

CRITICALACCOUNTING ESTIMATES

Thepreparation of consolidated financial statements in conformity with accounting principles generally accepted in the United States ofAmerica requires us to make a number of estimates and assumptions that affect the reported amounts of assets and liabilities and disclosureof contingent assets and liabilities at the date of the financial statements. Such estimates and assumptions affect the reported amountsof revenues and expenses during the reporting period. We base our estimates on historical experience and on various other assumptionsthat we believe to be reasonable under the circumstances. Actual results may differ materially from these estimates under different assumptionsor conditions. We continue to monitor significant estimates made during the preparation of our financial statements. On an ongoing basis,we evaluate estimates and assumptions based upon historical experience and various other factors and circumstances. We believe our estimatesand assumptions are reasonable under the current conditions; however, actual results may differ from these estimates under differentfuture conditions.

Webelieve that the estimates and assumptions that are most important to the portrayal of our financial condition and results of operations,in that they require subjective or complex judgments, form the basis for the accounting policies deemed to be most critical to us. Theserelate to revenue recognition, inventory overhead application, inventory reserve and share based compensation. We believe estimates andassumptions related to these critical accounting policies are appropriate under the circumstances; however, should future events or occurrencesresult in unanticipated consequences, there could be a material impact on our future financial conditions or results of operations. Wesuggest that our significant accounting policies be read in conjunction with this Management’s Discussion and Analysis of FinancialCondition and Results of Operations. Please refer to Note 2 of the Company’s consolidated financial statements for informationon Significant Accounting Policies.

REVENUERECOGNITION

TheCompany has various contracts with customers, and these contracts specify the recognition of revenue based on the nature of the transaction.

Revenuesfrom product sales are recognized at the time the product is shipped, customarily FOB shipping point, which is when the transfer of controlof goods has occurred, and title passes. This applies to clinical lab products sold to domestic and international distributors, includinghospitals, clinical laboratories, medical research institutions, medical schools, and pharmaceutical companies. OTC products are solddirectly to drug stores, e-commerce customers, and distributors, while physicians’ office products are sold to physicians and distributors.The Company does not allow for returns except in the event of defective merchandise and, therefore, does not establish an allowance forreturns. Additionally, the Company has contracts with customers that provide purchase discounts for achieving specified sales volumes.The Company regularly evaluates the status of these contracts and does not believe any discounts will be given through the end of thecontract periods.

Fordiagnostic testing services sold directly to patients or physician offices that require processing by a third-party CLIA-certified lab,we recognize revenue once the lab has completed the test results.

Forservices related to contract manufacturing, revenue is recognized when the service has been performed. Services for some contract worksare invoiced and recognized as the project progresses.

SHARE-BASEDCOMPENSATION

TheCompany follows the guidance of ASC 718, Share-based Compensation (“ASC 718”), which requires the use of the fair-value basedmethod to determine compensation for all arrangements under which employees and others receive shares of stock or equity instruments(options). The fair value of each option award is estimated on the date of grant using the Black-Scholes option-pricing model that usesassumptions for expected volatility, expected dividends, expected forfeiture rate, expected term, and the risk-free interest rate. TheCompany has not paid dividends historically and does not expect to pay them in the foreseeable future. Expected volatilities are basedon weighted averages of the historical volatility of the Company’s common stock estimated over the expected term of the options.The expected forfeiture rate is based on historical forfeitures experienced. The expected term of options granted is derived using the“simplified method” which computes expected term as the average of the sum of the vesting term plus the contract term ashistorically the Company had limited exercise activity surrounding its options. The risk-free rate is based on the U.S. Treasury yieldcurve in effect at the time of grant for the period of the expected term. The grant date fair value of the award is recognized underthe straight-line attribution method.

VALUATIONOF INVENTORIES, NET

Ourinventories are made up of raw materials, work in progress, and finished goods and are valued at thelower of cost (determined using a combination of specific lot identification and the first-in, first-out methods) or net realizable value.

Werecord valuation reserves for inventory items with excess quantities and obsolescence exposure. These reserves are estimates of a reductionin value to reflect inventory valuation at the lower of cost or net realizable value. Managementevaluates quantities on hand, physical condition, and technical functionality as these characteristics may be impacted by anticipatedcustomer demand for current products and new product introductions. The reserve is adjusted based on such evaluation, with a correspondingprovision included in cost of sales. Abnormal amounts of idle facility expenses, freight, handling costs and wasted material are recognizedas current period charges and the allocation of fixed production overhead is based on the normal capacity of the production facilities.Our inventory valuation reserves totaled $471,000 and $467,000 as of May 31, 2025 and 2024, representing approximately 24% and 16% ofour inventory, respectively.

RECENTACCOUNTING PRONOUNCEMENTS

RecentASU’s issued by the Financial Accounting Standards Board (“FASB”) and guidance issued by the SEC did not, or are notbelieved by the management to, have a material effect on the Company’s present or future consolidated financial statements.

InNovember 2023, the FASB issued ASU 2023-07, “Improvements to Reportable Segment Disclosures.” The ASU includes enhanced disclosurerequirements, primarily related to significant segment expenses that are regularly provided to and used by the chief operating decisionmaker (“CODM”). The amendments are to be applied retrospectively to all prior periods presented in the financial statements.ASU 2023-07 is effective for fiscal years beginning after December 15, 2023, with early adoption permitted. The Company adopted ASU 2023-07on May 31, 2025, and the adoption of this update did not have a material impact on the Company’s consolidated financial statements.

InDecember 2023, the FASB issued ASU 2023-09, “Income Taxes (Topic 740): Improvements to Income Tax Disclosures”. The ASU includesenhanced disclosure requirements, primarily related to the rate reconciliation and income taxes paid information. The amendments areto be applied prospectively in the financial statements. ASU 2023-09 is effective for fiscal years beginning after December 15, 2024,with early adoption permitted. The Company adopted ASU 2023-07 on May 31, 2025, and the adoption of this update did not have a materialimpact on the Company’s consolidated financial statements.

InNovember 2024, the FASB issued ASU 2024-03, “Income Statement—Reporting Comprehensive Income—Expense DisaggregationDisclosures (Subtopic 220-40)”. The ASU includes enhanced disclosure requirements, which mandates enhanced transparency in financialstatements by requiring detailed disclosures of specific expenses like inventory purchases, employee compensation, depreciation, andintangible asset amortization. ASU 2024-03 is effective for annual reporting periods beginning after December 15, 2026, and interim reportingperiods within annual reporting periods beginning after December 15, 2027. Early adoption is permitted. We are currently evaluating theeffect of adopting this pronouncement on our financial statements and disclosures.

ITEM7A. QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK

Weare a smaller reporting company as defined by Rule 12b-2 of the Securities Exchange Act of 1934 and are not required to provide the informationunder this item.

ITEM8. FINANCIAL STATEMENTS AND SUPPLEMENTARY DATA

BIOMERICA,INC. AND SUBSIDIARIES

INDEXTO CONSOLIDATED FINANCIAL STATEMENTS

ITEM9A. CONTROLS AND PROCEDURES

Attachedas exhibits to this Form 10-K are certifications of our Chief Executive Officer (“CEO”) and Chief Financial Officer (“CFO”)that are required in accordance with Rule 13a-14 of the Exchange Act. This “Disclosure Controls and Procedures” section includesinformation concerning the controls and controls evaluation referred to in the certifications.

EVALUATIONOF DISCLOSURE CONTROLS

Ourmanagement evaluated the effectiveness of our disclosure controls and procedures as defined in Rules 13a-15(e) and 15d-15(e) under theSecurities Exchange Act of 1934, as amended, or the Exchange Act, as of the end of the period covered by this report. Our managementrecognizes that any controls and procedures, no matter how well designed and operated, can provide only reasonable assurance of achievingtheir objectives and management is required to apply its judgment in evaluating the cost-benefit relationship of possible controls andprocedures. The disclosure controls and procedures have been designed to provide reasonable assurance of achieving their objectives.Our CEO and CFO concluded that our disclosure controls and procedures are effective at a reasonable assurance level as of May 31, 2025.Based on that evaluation the CEO and CFO concluded that information required to be disclosed in the reports that we file and submit underthe Exchange Act is (1) recorded, processed, summarized, and reported within the time periods specified in the Commission’s rulesand forms; and (2) accumulated and communicated to the Company’s management, including its CEO and CFO, as appropriate, to allowtimely decisions regarding required disclosure.

Companymanagement, including the CEO and CFO concluded that, as of May 31, 2025, the Company’s internal control over financial reportingwas effective.

CHANGESIN INTERNAL CONTROL OVER FINANCIAL REPORTING

Therehave been no changes in our internal control over financial reporting identified in connection with the evaluation that occurred duringthe quarter ended May 31, 2025, that have materially affected, or that are reasonably likely to affect, our internal control over financialreporting.

MANAGEMENT’SREPORT ON INTERNAL CONTROL OVER FINANCIAL REPORTING

Companymanagement is responsible for establishing and maintaining adequate internal control over financial reporting as defined in Rule 13a-15(f)under the Securities Exchange Act of 1934. The Company’s internal control over financial reporting is designed to provide reasonableassurance to the Company’s management and Board of Directors regarding the reliability of financial reporting and the preparationand fair presentation of financial statements for external purposes in accordance with accounting principles generally accepted in theUnited States of America.

Acompany’s internal control over financial reporting includes those policies and procedures that (i) pertain to the maintenanceof records that, in reasonable detail, accurately and fairly reflect the transactions and dispositions of the assets of the company;(ii) provide reasonable assurance that transactions are recorded as necessary to permit preparation of financial statements in accordancewith accounting principles generally accepted in the United States of America, and that receipts and expenditures of the company arebeing made only in accordance with authorizations of management and directors of the company; and (iii) provide reasonable assuranceregarding prevention or timely detection of unauthorized acquisition, use, or disposition of the company’s assets that could havea material effect on the consolidated financial statements.

Theeffectiveness of any system of internal control over financial reporting is subject to inherent limitations, including the exercise ofjudgment in designing, implementing, operating, and evaluating the controls and procedures. Because of these inherent limitations, internalcontrol over financial reporting cannot provide absolute assurance regarding the reliability of financial reporting and may not preventor detect misstatements. Also, projections of any evaluation of effectiveness to future periods are subject to the risk that controlsmay become inadequate because of changes in conditions, or that the degree of compliance with the policies or procedures may deteriorate.

Companymanagement, with the participation of the CEO and the CFO, evaluated the effectiveness of the Company’s disclosure controls andprocedures as defined in Rules 13(a)-15(e) and 15(d)-15(e) under the Securities Exchange Act of 1934, as amended, or the Exchange Act,as of the end of the period covered by this report. In making this assessment, Management used the criteria set forth by the Committeeof Sponsoring Organizations of the Treadway Commission (“COSO”) in Internal Control - Integrated Framework (2013). Basedon this assessment, management, with the participation of the CEO and CFO, believes that, as of May 31, 2025, the Company’s internalcontrol over financial reporting was effective based on those criteria.

Companymanagement will continue to monitor and evaluate the effectiveness of its disclosure controls and procedures and its internal controlsover financial reporting on an ongoing basis and are committed to taking further action and implementing improvements, as necessary andas funds allow.

Note:This 10-K does not include an attestation report of the Company’s independent registered public accounting firm regarding internalcontrol over financial reporting. Management’s report was not subject to attestation by the Company’s independent registeredpublic accounting firm pursuant to temporary rules of the Securities and Exchange Commission that permit the Company to provide onlymanagement’s report in this 10-K.

ITEM9B. OTHER INFORMATION.

Nonenoted.

ITEM9C. DISCLOSURE REGARDING FOREIGN JURISDICTIONS THAT PREVENT INSPECTIONS.

Notapplicable.

PARTIII

ITEM10. DIRECTORS, EXECUTIVE OFFICERS, AND CORPORATE GOVERNANCE

Theinformation required by this item will be disclosed in our definitive proxy statement on Schedule 14A (the “Proxy Statement”)for our 2025 Annual Meeting of Stockholders and is incorporated by reference herein. Our Proxy Statement will be filed with the SEC within120 days after the end of the Company’s fiscal year ended May 31, 2025, pursuant to Regulation 14A under the Exchange Act.

ITEM11. EXECUTIVE COMPENSATION

Theinformation required by this item will be disclosed in the Proxy Statement and is incorporated herein by reference.

ITEM12. SECURITY OWNERSHIP OF CERTAIN BENEFICIAL OWNERS AND MANAGEMENT AND RELATED STOCKHOLDER MATTERS

Theinformation required by this item will be disclosed in the Proxy Statement and is incorporated herein by reference.

ITEM13. CERTAIN RELATIONSHIPS AND RELATED TRANSACTIONS AND DIRECTOR INDEPENDENCE

Theinformation required by this item will be disclosed in the Proxy Statement and is incorporated herein by reference.

ITEM14. PRINCIPAL ACCOUNTANT FEES AND SERVICES

Theinformation required by this item will be disclosed in the Proxy Statement and is incorporated herein by reference.

PARTIV

ITEM15. EXHIBITS LIST AND FINANCIAL SCHEDULES

Thefollowing documents are filed as part of this Annual Report on Form 10-K:

Thecertifications attached as Exhibits 32.1 and 32.2 accompany this Annual Report pursuant to 18 U.S.C. Section 1350, as adopted pursuantto Section 906 of the Sarbanes-Oxley Act of 2002, as amended, and shall not be deemed “filed” by the registrant for purposesof Section 18 of the Exchange Act and are not to be incorporated by reference into any of the registrant’s filings under the SecuritiesAct or the Exchange Act, irrespective of any general incorporation language contained in any such filing.

SIGNATURES

Inaccordance with Section 13 or 15(d) of the Securities Exchange Act of 1934, the Registrant caused this report to be signed on its behalfby the undersigned, thereunto duly authorized.

Inaccordance with the Exchange Act, this report has been signed below by the following persons on behalf of the registrant and in the capacitiesand on the dates indicated:

Signatureand Capacity

BIOMERICA,INC. AND SUBSIDIARIES

TABLEOF CONTENTS

REPORTOF INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRM

Tothe Shareholders and Board of Directors

Biomerica,Inc.

Opinionon the Consolidated Financial Statements

Wehave audited the accompanying consolidated balance sheets of Biomerica, Inc. (the “Company”) as of May 31,2025 and 2024, the related consolidated statements of operations and comprehensive loss, shareholders’ equity, and cash flows foreach of the years then ended, and the related notes (collectively, the “consolidated financial statements”). In our opinion,the consolidated financial statements present fairly, in all material respects, the consolidated financial position of the Company asof May 31, 2025 and 2024, and the consolidated results of its operations and its cash flows for each of the years then ended, in conformitywith U.S. generally accepted accounting principles.

GoingConcern

Theaccompanying consolidated financial statements have been prepared assuming that the Company will continue as a going concern. As describedin Note 2 to the consolidated financial statements, the Company has experienced recurring losses and negative cash flows from operationsand has an accumulated deficit and limited liquid resources. These matters raise substantial doubt about the Company’s abilityto continue as a going concern. Management’s plans in regard to these matters are also described in Note 2. The consolidated financialstatements do not include any adjustments that might result from the outcome of this uncertainty.

Basisfor Opinion

Theseconsolidated financial statements are the responsibility of the Company’s management. Our responsibility is to express an opinionon the Company’s consolidated financial statements based on our audits. We are a public accounting firm registered with the PublicCompany Accounting Oversight Board (United States) (“PCAOB”) and are required to be independent with respect to the Companyin accordance with the U.S. federal securities laws and the applicable rules and regulations of the Securities and Exchange Commissionand the PCAOB.

Weconducted our audits in accordance with the standards of the PCAOB. Those standards require that we plan and perform the audits to obtainreasonable assurance about whether the consolidated financial statements are free of material misstatement, whether due to error or fraud.The Company is not required to have, nor were we engaged to perform, an audit of its internal control over financial reporting. As partof our audits, we are required to obtain an understanding of internal control over financial reporting but not for the purpose of expressingan opinion on the effectiveness of the Company’s internal control over financial reporting. Accordingly, we express no such opinion.

Ouraudits included performing procedures to assess the risks of material misstatement of the consolidated financial statements, whetherdue to error or fraud, and performing procedures that respond to those risks. Such procedures included examining, on a test basis, evidenceregarding the amounts and disclosures in the consolidated financial statements. Our audits also included evaluating the accounting principlesused and significant estimates made by management, as well as evaluating the overall presentation of the consolidated financial statements.We believe that our audits provide a reasonable basis for our opinion.

REPORTOF INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRM (continued)

CriticalAudit Matter

Thecritical audit matter communicated below is a matter arising from the current-period audit of the consolidated financial statements thatwas communicated or required to be communicated to the audit committee and that (1) relate to accounts or disclosures that are materialto the financial statements and (2) involved our especially challenging, subjective, or complex judgments. The communication of criticalaudit matters does not alter in any way our opinion on the consolidated financial statements, taken as a whole, and we are not, by communicatingthe critical audit matter below, providing separate opinions on the critical audit matter or on the accounts or disclosures to whichthey relate.

InventoryValuation

CriticalAudit Matter Description

Asdescribed in Note 2 to the Company’s consolidated financial statements, the Company values inventory at the lower of cost ornet realizable value with cost inclusive of estimates for reasonable allocations of labor and overhead costs. Also, managementperiodically reviews inventory for excess quantities and obsolescence. Management evaluates quantities on hand, physical condition,and technical functionality as these may be impacted by customer demand for current products and new product introductions. Auditingthe Company’s estimates for capitalized labor and overhead was challenging due to the extensive use of estimates throughoutthis process, including the amount of labor and overhead costs allocable to inventory production and the amount of labor andoverhead costs allocable to specific ending inventory product quantities. Auditing the Company’s estimates for slow-moving andobsolete inventories was challenging due to the inherently judgmental nature of forecasting future sales and usage of a significantnumber of diverse inventory items.

Howthe Critical Audit Matter Was Addressed in the Audit

Totest the valuation of the Company’s inventory, we performed the following audit procedures:

Wehave served as the Company’s auditor since 2022.

Irvine,California

August29, 2025

BIOMERICA,INC. AND SUBSIDIARIES

CONSOLIDATEDBALANCE SHEETS

Seeaccompanying notes to consolidated financial statements and Report of Independent Registered Public Accounting Firm.

BIOMERICA,INC. AND SUBSIDIARIES

CONSOLIDATEDSTATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS

Seeaccompanying notes to consolidated financial statements and Report of Independent Registered Public Accounting Firm.

Biomerica,Inc.

ConsolidatedStatements Shareholders’ Equity

Forthe Year Ended May 31, 2025