NASDAQ: TOMZ

2025 Highlights

While 2025 presented revenue headwinds, the year was marked by significant commercial momentum, new market entries, product validation across all four divisions, and a strong exit pipeline. The following summarizes key announcements and milestones during fiscal year 2025:

First Quarter

On January 10, 2025, we announced support for partners and clients preparing for emerging public health threats, including RSV, Human Metapneumovirus (HMPV), and highly pathogenic Avian Influenza (H5N1), leveraging SteraMist for infection prevention across government agencies, commercial clients, and school districts.

On February 4, 2025, we deployed SteraMist iHP technology to support wildfire recovery efforts in California communities.

On February 27, 2025, we achieved compliance recognition on the Avetta vendor management platform, reflecting our commitment to health, safety, and environmental (HSE) excellence. This follows our 2024 Gold Safety Award from Highwire. Affiliations with Avetta, Highwire, and ISNetworld open new avenues for TOMI with a broader network of industry leaders.

On March 20, 2025, we deployed SteraMist iHP technology at NASA’s Johnson Space Center, marking our expansion into the aerospace sector.

On March 21, 2025, we announced an expansion into aquaculture with new partner Algafeed.

On March 24, 2025, we announced a contract to install a SteraMist iHP Custom Engineered System (“CES”) at a leading university in Rhode Island, valued at approximately $450,000.

On March 25, 2025, we announced an OEM partnership with PBSC, a premier manufacturer of high-containment, material decontamination, and cleanroom solutions, integrating iHP into their passthrough hatches and chambers.

Second Quarter

On May 30, 2025, the Board of Directors (the “Board”) appointed Mr. David Vanston as Chief Financial Officer of the Company, bringing substantial financial accounting and reporting expertise to support the Company's operations and internal control improvement initiatives.

On June 12, 2025, SteraMist was honored with the 2025 “Disinfection and Decontamination Products Company of the Year” award from Medtech Outlook.

On June 16, 2025, we announced the first commercial installation of our new SteraMist Integration System – Standalone (“SIS-SA”) with a leading CDMO, marking the commercial launch of this product line.

On June 23, 2025, we announced that SteraMist demonstrated efficacy in combating Honeybee Colony Collapse, positioning TOMI to support global food security through environmental biosecurity.

Third Quarter

On July 16, 2025, we announced the successful SIS-SA installation in the pharmaceutical isolator market. Since that announcement, we have integrated SteraMist iHP into two additional enclosures with a strong pipeline for further installations.

On August 11, 2025, our East Coast distributor Ares Scientific announced an additional win with a new university client using our SIS platform, strengthening our academic vertical.

On August 12, 2025, we announced a major new customer in the eye health sector, comparable in scale to Pfizer and Merck, who implemented SteraMist iHP at two facilities in under four months and placed open BIT Solution orders for 2026.

On September 16, 2025, the Company announced the appointment of Francesco Fragasso to its Board, strengthening TOMI's corporate governance and bringing additional expertise to support the Company's strategic growth initiatives.

On September 18, 2025, the FDA broadened the permitted use of hydrogen peroxide as a direct food additive. This regulatory change significantly expands the potential application of SteraMist iHP in the food safety market, particularly for ready-to-eat food processing.

On September 24, 2025, we onboarded the first of three major commercial service provider companies in Q3, all of which show strong potential for expanded SteraMist iHP adoption through their franchise networks.

Fourth Quarter

On October 1, 2025, we announced the appointment of Harold W. Paul to the Company’s Board.

On October 1, 2025, we announced the purchase of SteraMist iHP equipment and BIT Solution totaling $175,000 by Trauma and Casualty Team (T.A.C.T.) franchises, a premier provider of decontamination services operating 18 franchises across the United States. T.A.C.T.'s adoption of SteraMist technology represents a key milestone in the Company's commercial growth strategy.

On November 5, 2025, the Company entered into an equity line of credit (“ELOC”) pursuant to which the Company has the option to sell, from time to time, up to $20,000,000 shares of its common stock over a 24-month period. The ELOC provides the Company with flexible access to capital on an as-needed basis, subject to applicable Nasdaq listing requirements.

On November 10, 2025, we showcased our SIS platform at the AALAS 76th National Meeting in Long Beach, California, a key lead generation event for our animal research vertical.

On November 26, 2025, we announced a custom integration pipeline valued at approximately $3 million, with ten active projects across our SIS and CES platforms. Strategic OEM partnerships with ESCO, Steelco, PBSC, Nuaire, and Getinge are driving platform growth and broader distribution.

On December 18, 2025, we secured a signed purchase order valued at approximately $500,000 from a global biopharmaceutical leader for the integration of SteraMist iHP into passthrough fill boxes used in sterile manufacturing.

On December 22, 2025, we announced the adoption of SteraMist iHP by a leading Cell and Gene Therapy (“CGT”) manufacturer for a commercial-scale pharmaceutical facility, including full IQ/OQ qualification and whole-facility iHP Corporate Service fogging of manufacturing suites, QC labs, and support spaces.

We are actively pursuing additional EPA labels and await further acceptance of our food safety label submitted in mid-2025, while preparing to file for a fifth label based on the above referenced studies conducted with Plum Island. Sales of our BIT Solution have remained stable, but we are fulfilling open orders and automatic shipments for customers, with a notable increase in demand from food safety clients. The FDA's late 2025 announcement, along with ongoing individual customer studies, has enhanced our visibility and sales in the Food Safety sector. While we face challenges with some international registrations, we are committed to overcoming these hurdles, which we believe will ultimately drive sales growth for TOMI. Additionally, we continue to invest in safety and compliance recognitions, such as Avetta and ISN, which are increasingly becoming prerequisites for many of our integration projects.

Regarding the referenced $3 million pipeline for integration projects on November 26, 2025, which encompasses our SIS platform, Hybrid, and CES offerings, approximately $1.6 million has been awarded, with $800,000 recognized since the announcement. While the SIS and iHP Passthrough was a success, we have since started our second project with OEM partner, PBSC. These projects vary in scope, including manufacturing, installation, and validation requirements, which may extend over multiple quarters depending on customer schedules. We anticipate the remaining pipeline to be awarded in the first half of 2026. Additionally, we have identified an extra $1.7 million in projected integration pipeline from bids written specific for iHP technology and from our existing customer and contractor relationships. This of course does not include our entire integration pipeline which stands at $10 million.

The Science Behind the Technology

BIT technology was initially developed in response to weaponized anthrax spore attacks. It aerosolizes and activates a 7.8% hydrogen peroxide solution through an atmospheric cold plasma arc, producing a fine aqueous mist (0.3–3 μm) with a high concentration of hydroxyl radicals (“OH”). These radicals damage pathogens via oxidation of proteins, carbohydrates, and lipids, rendering DNA and RNA inactive and causing complete cellular disruption.

SteraMist BIT was EPA-registered (90150-2) in June 2015 as the first equipment-plus-solution combination hospital-healthcare disinfectant. Our EPA label supports claims against Staphylococcus, MRSA, Salmonella, H1N1, C. difficile spores, Norovirus, and Emerging Viral Pathogens including SARS-CoV-2 variants. In 2021, our 0.35% hydrogen peroxide product received separate EPA registration (90150-3). In 2022, SteraMist was added to the EPA’s List Q for rare and novel viruses. GLP efficacy data supports all label claims.

Our Customers

SteraMist is used by organizations across life sciences, hospital-healthcare, food safety, and commercial sectors. Our current client roster includes Fortune 100 pharmaceutical and healthcare companies such as Pfizer, Merck, AbbVie, Bausch & Lomb, ThermoFisher Scientific, Eli Lilly and Company, FUJIFILM Diosynth Biotechnologies USA, and Fresenius Kabi, as well as government agencies including the National Institutes of Health (“NIH”), the U.S. Department of Agriculture (“USDA”), Centers for Disease Control and Prevention (“CDC”), United States Army Medical Research Institute of Infectious Diseases and of Chemical Defense (“USAMRIID” and “USAMRICD”) and NASA’s Johnson Space Center. In food safety, our customers include Nestle, Sensient Technologies Corporation, Mayorga Organics, Lakeview Farms, LLC, Batory Foods, Danone, and Perdue. Healthcare customers include Tower Health, Novant Health, Corewell Health, NorthEast Medical Services, St. Jude Children’s Research Hospital, Edgewell Personal Care, and Mass General Brigham. And, we continue to work in tandem with service providers from franchises of DKI, First Onsite, Steri-Clean, Triumvirate Environmental, and Controlled Contamination Services, LLC.

Our products and services are offered through direct sales, independent representatives, and a global network of distributors and certified service providers operating under the SteraMist Pro Certified (“SPC”) program.

Industries and Market Segments

Our operations are organized around four divisions, each targeting specific regulatory and operational requirements:

Life Sciences

The life sciences sector was among the first to adopt SteraMist iHP, recognizing the limitations of traditional vaporized hydrogen peroxide (VHP) and harsh chemical gaseous methods. Pharmaceutical manufacturers, Contract Development and Manufacturing Organizations (“CDMOs”), and research institutions require fully automated, validated decontamination with minimal downtime. Our CES, Hybrid, and SIS product lines are specifically designed to address these requirements, with all installations undergoing full IQ/OQ/PQ validation. The onshoring of pharmaceutical manufacturing, particularly in Virginia with commitments from Merck, Eli Lilly, and AstraZeneca, positions us favorably for expanded adoption in the near term.

Hospital-Healthcare

Healthcare-associated infections (“HAIs”) affect 7–10% of hospitalized patients globally each year, creating significant demand for advanced disinfection. TOMI targets this market by providing rapid-turnaround disinfection for operating rooms, pharmacies, ambulances, and emergency environments. We are expanding our presence through partnerships with group purchasing organizations (“GPOs”) such as Vizient and through targeted educational campaigns aimed at facility managers and infection control professionals.

Food Safety

Food safety regulations require rigorous sanitation across all stages of food handling and processing. The FDA’s 2025 final rule broadening the permitted use of hydrogen peroxide as a direct food additive significantly enhances our positioning in this sector, opening the door for iHP application on food contact surfaces and food products themselves, particularly in the ready-to-eat (“RTE”) segment. In 2025, we experienced significant growth in interest within the Food Safety industry, as we conducted a diverse array of specialized tests in collaboration with industry stakeholders. We are committed to not only expanding our project pipeline but also enhancing awareness of our technology and building relevant relationships in the field, which offers effective application methods in an industry adapting to a new standard of cleanliness.

Commercial

Our Commercial division serves aviation, hospitality, education, government, emergency services, and restoration sectors through a growing network of certified service providers. We have established relationships with large franchise networks including T.A.C.T. (18 U.S. locations), Steri-Clean (approximately 60 franchises), and others. SteraMist’s unique combination of rapid deployment, no preconditioning requirements, and minimal PPE needs makes it well-suited for high-frequency commercial use.

As we advance our efforts to educate various sectors about the implementation of SteraMist iHP and the adoption of our handheld equipment in schools, transportation, and hospitality as standard protocols, we are witnessing an integration of our service providers, primarily from the commercial division, with our Life Sciences division. This convergence includes providers specializing in lab clean-up and Biological Safety Cabinets (BSCs) certification, who are increasingly adopting iHP technology, specifically the SIS platform of products. This development fosters competition among them, as our iHP technology offers a faster efficient solution that can effectively replace two steps in a traditional three-step cleaning process, enabling these providers to enhance productivity in their daily operations and offer iHP over the traditional solutions the industry has become accustomed to.

Research and Development

Our research and development efforts focus on improving, extending, and applying our proprietary iHP technology across new markets and use cases. Research and development expenses for the years ended December 31, 2025 and 2024 were approximately $290,000 and $291,000, respectively.

In the past, we have made significant strides in expanding our regulatory registrations and efficacy study portfolio to capitalize on new and existing market opportunities. Notably, we completed a second 24-month stability study for our 7.8% BIT Solution, which met EPA requirements and confirmed safe shipping and storage. Our 0.35% hydrogen peroxide product received EPA registration for greenhouse and pre- and post-harvest applications, while we pursued further studies on food safety pathogens. Additionally, we've received validation from the Department of Homeland Security's Plum Island Animal Disease Center for iHP's effectiveness against foot-and-mouth disease virus and African Swine Fever, while also working on new labels to support the cannabis industry and researching best practices for minimizing emergency responder exposure to synthetic opioids and exploring iHP as an alternative to ethylene oxide (EtO) in sterilization applications.

In 2025, we initiated several key projects that we continue to advance in the following years. Notably, we began drafting Standard Operating Procedures (SOPs) for live-use applications of iHP in bee hives and continued our international studies to comply with necessary regulations and timelines. We focused on developing SOPs for turnout gear for firefighters, assessing both carcinogen proofing and material compatibility to identify optimal iHP application methods for this group. Additionally, we addressed industry-specific requirements for food safety, particularly concerning Listeria monocytogenes, with positive results from onsite demonstrations and tests on food preservation involving cheese, strawberries, and cut cantaloupe. We also maintained our collaboration with universities to develop protocols for formal studies targeting C. auris, prions, and pinworms, while planning to conduct USP 1072 studies for our Life Sciences division. Lastly, we recognized the need for more data on live applications to tackle the underrepresented public health issue of mycotoxins globally.

We conduct annual self-audits of all SOPs and product compliance processes.

Revenue Sources

We have two sources of revenue, Product and Service, with BIT solution sales from equipment usage leading to a razor-blade model, recurring revenue.

Products Revenue line

The SteraMist product line encompasses both mobile and permanently integrated solutions. Handheld devices provide convenient point-and-spray application at 5 seconds per square foot. Automated environment systems achieve full room disinfection of spaces up to 103.8 m³ (3,663 ft³) using three applicators in approximately 45 minutes.

Off-the-Shelf Mobile Equipment

SteraPak

An all-in-one backpack system with rechargeable battery and cordless operation. Compatible with AC and DC power for use in all countries. Sold with a case of BIT Solution (eight 32-oz bottles).

SteraMist Surface Unit

The original handheld, fully portable unit for quick-turnover disinfection of any affected space. Sold with a case of BIT Solution (four-gallon bottles).

SteraMist Environment System (ENV)

A transportable, remotely controlled system for complete room disinfection. Supports manual and fogging modes; provides downloadable cycle data and audit reporting required by Life Sciences facilities. Sold with a case of BIT Solution (four-gallon bottles). The fourth-generation ENV, featuring a 24-volt universal outlet model, is now commercially available. This model converts more BIT Solution to hydroxyl radicals, lowering residual H₂O₂ PPM levels for faster re-entry times, and includes eight programmable outputs for integration with external equipment.

Total Disinfection Cart

Designed with input from healthcare EVS teams. Houses the Surface Unit, a portable H₂O₂ monitor, Carbon Air Scrubber, Respiratory Protection System, and a custom ICU 55-minute terminal cleaning protocol.

SteraMist Transport

An all-in-one dual-voltage fogging product for vehicles. Application time of 20 minutes per 1,000 cubic feet. Features remote start and cycle notification lights. Sold with a case of BIT Solution (eight 32-oz bottles). The Transport completed its soft launch phase in 2025 and has been placed with international customers and domestic distributors for live practical assessment.

NV+

A solution for smaller areas and budgets, featuring precise volume-based dosing, remote activation, audit reporting, and cleanroom compliance (GMP, cGMP, GLP). Delivers a 36-minute injection cycle for spaces up to 1,800 cubic feet via a telescopic rotating applicator.

Integration Product Offerings:

SteraMist Hybrid

Combines CES-style permanently installed stainless-steel applicators with the ENV generator via a central docking hub. Compliant with cGMP, GMP, and ISO standards. Supports four outputs and analog input from an H₂O₂ sensor. Designed for facilities that require automated decontamination within budget or timeline constraints that do not accommodate a full CES. The Hybrid was first installed at Xenith Pharmaceutical (f/k/a Indigo Pharmaceutical) and subsequently at BeSpoke Pharmaceuticals, with ongoing customer interest driven in part by referrals from existing installations.

SteraMist Integration System (SIS)

The SIS lineup provides versatile enclosure decontamination across three configurations: SIS-SA (stand-alone, stocked inventory), SIS-Pharm (made-to-order for pharmaceutical applications), and SIS-MFG (OEM-integrated for manufacturer partner enclosures). Launched in the second half of 2024, the SIS achieved its first commercial installation in Q2 2025 at a leading CDMO and has since been adopted across pharmaceutical isolators, biosafety cabinets, and OEM cleanroom enclosures. As of year-end 2025, we had ten active SIS and CES integration projects with a combined pipeline valued at approximately $3 million. Strategic OEM partnerships with ESCO, Steelco, PBSC, Nuaire, and Getinge are expanding our route to market for this platform.

Stainless Steel 90-Degree Applicator

Redesigned and manufactured to a 316 stainless steel 90-degree configuration. The ideal applicator for all SIS product lines; available with a flange for permanent or semi-permanent installation.

Custom Engineered System (CES)

A permanent installation for rooms requiring routine automated decontamination, fully integrated into the facility’s HVAC system with permanently mounted applicators and optional SCADA monitoring. Custom-designed, procured, and installed; all CES installations worldwide have undergone full IQ/OQ/PQ validation.

As of year-end 2025, we had ten active integration projects with a combined pipeline valued at approximately $3 million. Strategic OEM partnerships with ESCO, Steelco, PBSC, Nuaire, and Getinge are expanding our route to market for this platform.

Recent Developments

SteraMist engineering continues to advance turnkey decontamination integrations for cleanroom chambers, biosafety cabinets, passthroughs, isolators, and cage washers in collaboration with key enclosure manufacturers. Our 2025 engineering focus has centered on three priorities: expanding the SIS platform into new OEM channels, advancing the PBSC partnership toward its first completed collaborative installation, and scaling CES qualification capabilities in-house to reduce reliance on third-party consultants and improve margin on validation revenue.

Collectively, our installed base of CES, Hybrid, and SIS systems continues to grow, supporting recurring BIT Solution consumption and long-term customer relationships. We believe the shift toward automated, validated, and integrated decontamination, driven by pharmaceutical manufacturing trends including continuous bioprocessing, modular facilities, and AI-enabled manufacturing, positions our product portfolio favorably for continued adoption.

Competition

The disinfection, decontamination, and sanitization industry is intensely competitive and highly regulated across all four of our divisions. Comparable competitors include companies marketing hydrogen peroxide-based products, such as Steris Corporation, Bioquell (owned by Ecolab), and The Clorox Company, as well as numerous ultraviolet and quaternary ammonium chemical companies. Some competitors have longer operating histories, greater name recognition, and substantially greater financial and marketing resources.

SteraMist iHP achieves a 6-log (99.9999%) or greater kill rate, compared to 99.9% (sanitizing) or 99.99% (disinfection) achieved by most household and industrial disinfectants. Per EPA Registration Nos. 90150-2 and 90150-3.

SteraMist’s key competitive advantages include:

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Ready-to-use formula — no mixing required,

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Reaches above, below, and around surfaces beyond traditional sprays and wipes,

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No preconditioning of space required,

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No wipe, no rinse — leaves no residues,

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Gentle on electronics and sensitive equipment,

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Minimal PPE requirements per EPA label,

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Does not contain heavy metals, dyes, fragrances, silver ions, or peracetic acid,

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Only by-products are oxygen and humidity,

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Fully validated to GMP/GLP standards with downloadable audit reporting,

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Mobile and portable for rapid deployment; also available as permanent installed systems,

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DOT transport advantage: our BIT Solution’s 7.8% hydrogen peroxide concentration falls below the DOT threshold prohibiting air shipment of products containing greater than 8% hydrogen peroxide — competitors relying on higher-concentration formulations must ship by rail, road, or sea, adding cost and lead time.

We go to market through a direct sales force, independent representatives, and exclusive and non-exclusive international distributors, supported by the SteraMist Pro Certified (SPC) service provider program and strategic alliances with construction companies, engineers, and design firms that facilitate CES and SIS adoption in new facility construction and renovation projects. This multi-channel approach, combined with our qualification services and growing OEM partnerships, creates a durable competitive position that is difficult to replicate quickly.

Manufacturing

We outsource the manufacturing and blending of our SteraMist® equipment and BIT™ Solution. Equipment is manufactured by ISO 9001 registered companies with facilities in Pennsylvania, Delaware, New Jersey, North Carolina, California, and Australia. Our BIT Solution is blended by an EPA-approved blender using a single active ingredient: 7.8% hydrogen peroxide. TOMI maintains full creative control throughout design and manufacturing, and neither our manufacturer nor blender may modify products without our written consent.

Intellectual Property

Our intellectual property portfolio is a key strategic asset supporting our global market position. We hold or have pending over 25 utility or design patents worldwide, protecting both the methods and systems underlying our SteraMist® BIT™ platform, with U.S. patents extending through 2038. Recent additions include patents for backpack decontamination units, mobile carts, and applicator technology in the United States, along with new protection in Singapore, Korea, and other jurisdictions.

We hold more than 30 design patents for decontamination devices, covering applicators, chambers, carts, and surface-mounted systems, across major global markets including the United States, China, Japan, Korea, and the United Kingdom. We continue to pursue applications in Europe, China, and Australia for further additional applications of SteraMist BIT, including food decontamination and iHP-enabled “immune building” biosecurity systems.

In addition, we maintain over 200 trademarks registered or pending in multiple classes across the globe, covering chemical formulations, sterilization equipment, services, and training.

Government Regulation

Our business is subject to government regulations in all countries in which we operate. In the United States, the EPA, FDA, and other authorities regulate the development, manufacture, sale, and distribution of our products. We believe we are currently compliant in all material respects with applicable regulatory requirements, and to date, every registration we have applied for has been accepted.

Human Capital

As of March 20, 2026, we employ 20 full-time executive, operational, and administrative personnel. Given our size, we operate with a lean, cross-functional team in which individual contributors carry significant responsibility across sales, service delivery, engineering, and regulatory affairs. We believe our relations with our employees are good and that our ability to attract and retain qualified personnel is supported by our differentiated technology platform and mission-driven culture.

Available Information

We make available free of charge on or through our corporate website, https://tomimist.com/, our Annual Report on Form 10-K, Quarterly Reports on Form 10-Q, Current Reports on Form 8-K, proxy statements, and all amendments to those filings as soon as reasonably practicable after such material is electronically filed with, or furnished to, the Securities and Exchange Commission (“SEC”). We provide several website addresses in this Annual Report on Form 10-K. These website addresses are intended to provide inactive, textual references only. The information contained on the websites is not part of or incorporated by reference into this Annual Report on Form 10-K, unless specifically stated therein.

In addition, the SEC maintains a website that contains reports, proxy statements, and other information about issuers, such as TOMI, who file electronically with the SEC. The address of the website is www.sec.gov.