TOMI Environmental Solutions Expands Footprint in Cell and Gene Therapy Sector with Multi-Stage SteraMist iHP Implementation at a New Pharmaceutical Manufacturing Site

Rhea-AI Summary

TOMI Environmental Solutions (NASDAQ: TOMZ) announced on December 22, 2025 that a leading Cell and Gene Therapy manufacturer has adopted SteraMist ionized Hydrogen Peroxide (iHP) technology for a commercial-scale pharmaceutical facility.

The multi-stage implementation includes multiple SteraMist systems for surface treatment and automated room fogging, a full SOP development package, and an Installation and Operational Qualification (IQ/OQ) delivered by TOMI’s Qualification Team. TOMI’s iHP Corporate Service will perform whole-facility fogging across manufacturing suites, QC labs, and support spaces to support cGMP contamination control.

Key Figures

Current Price $0.7701 Pre-news price on 2025-12-22

52-week Range $0.6273–$1.50 Price vs. 52-week low/high before news

Recent Purchase Order $500,000 SteraMist iHP integration for global biopharma leader (Dec 18, 2025)

Custom Pipeline $3 million Life sciences and medical device integration pipeline (Nov 26, 2025)

Shelf Registration $50,000,000 S-3 universal shelf filed Nov 14, 2025

Equity Line of Credit $20,000,000 Hudson Global Ventures ELOC over 24 months

Quarter Revenue $1.03 million Quarter ended June 30, 2025, from 10-Q

Revenue Decline 66% Year-over-year revenue drop vs. $3.01 million prior year quarter

Market Reality Check

$0.7990 Last Close

Volume Volume 164,749 is about 7.1x the 20-day average of 23,205, indicating elevated interest ahead of this announcement. high

Technical Shares trade below the 200-day MA, with price at 0.7701 versus MA 0.9, despite today’s positive news.

Peers on Argus

Sector peers showed mixed moves, with LIQT up 1.67% and ZONE up 3.46%, while CLIR and DEVS fell 5.75% and 4.35%. TOMZ’s gain of 2.82% appears more company-specific than part of a broad sector trend.

Historical Context

Date	Event	Sentiment	Move	Catalyst
Dec 18	Biopharma order win	Positive	-0.1%	Approx. $500,000 SteraMist iHP integration for global biopharma leader.
Dec 15	Market outreach	Positive	-5.1%	Call for cruise lines to adopt hospital-grade SteraMist decontamination.
Dec 04	Investor conference	Positive	-0.3%	Sidoti investor conference presentation on BIT platform and SteraMist.
Nov 26	Integration pipeline	Positive	+2.5%	Announcement of about $3 million custom integration pipeline and partnerships.
Nov 17	Shelf & ELOC	Negative	-8.6%	$50 million shelf filing and $20,000,000 equity line of credit agreement.

Pattern Detected

Recent history shows several positive commercial and pipeline updates often met with flat or negative next-day moves, while financing news and larger pipeline wins have coincided with more pronounced declines or gains.

Recent Company History

Over the last few months, TOMI highlighted multiple SteraMist iHP wins, including a purchase order of approximately $500,000 with a global biopharma leader and a custom integration pipeline of about $3 million. The company also filed a $50 million universal shelf and arranged an $20,000,000 equity line of credit, adding financing flexibility. Some of these positive commercial and strategic updates saw muted or negative price reactions, while the larger pipeline announcement on Nov. 26 coincided with a modest gain.

Regulatory & Risk Context

Active S-3 Shelf Registration 2025-11-14

$50,000,000 registered capacity

An effective S-3 shelf filed on Nov. 14, 2025 permits TOMI to offer up to $50,000,000 in various securities over time once effective, providing flexibility for working capital, investments, debt repayment, or acquisitions. The shelf has 0 recorded usages in the provided context, so any future drawdowns would depend on subsequent prospectus supplements and market conditions.

Market Pulse Summary

This announcement underscores deeper penetration of SteraMist iHP into high-specification environments, with a multi-stage implementation at a commercial cell and gene therapy facility and support packages like SOP development and IQ/OQ. It builds on earlier orders and pipeline wins, while the company also maintains a $50,000,000 shelf and $20,000,000 equity line. Investors may watch for additional CGT or 503B deployments, revenue trends, and progress toward resolving Nasdaq listing deficiencies and historical going-concern risks.

Key Terms

cell and gene therapy medical

"a leading Cell and Gene Therapy (CGT) manufacturer has adopted"

Therapies that use living cells or altered genes to treat or cure disease by repairing, replacing or reprogramming parts of the body; think of it as swapping or reprogramming malfunctioning hardware or software inside the body. Investors watch these treatments closely because they can command high prices and offer one-time or long-lasting benefits, but they also carry big development costs, complex manufacturing and regulatory risks that can cause large swings in a company’s value.

ionized hydrogen peroxide technical

"has adopted SteraMist ionized Hydrogen Peroxide (iHP) technology"

Ionized hydrogen peroxide is a form of hydrogen peroxide that has been electrically charged to create reactive particles. This process enhances its ability to kill germs and break down contaminants, making it more effective for cleaning and disinfecting. For investors, understanding its use and effectiveness can be important when evaluating companies involved in health, sanitation, or innovative cleaning technologies.

current good manufacturing practices (cGMP) regulatory

"to meet the rigorous current Good Manufacturing Practices (cGMP) requirements"

Current Good Manufacturing Practices (cGMP) are a set of required quality rules and procedures that companies must follow when making drugs, medical devices, or related products to ensure they are safe, pure, and consistent—think of them as a strict recipe and checklist for production. Investors care because failure to meet these standards can halt product approvals, trigger recalls, increase costs, and damage reputation, all of which directly affect a company’s revenue and valuation.

contamination control strategy (ccs) technical

"implementation strengthens the facility’s Contamination Control Strategy (CCS)"

A contamination control strategy (CCS) is a company’s planned set of processes, checks and equipment designed to keep products and facilities free from unwanted microbes, particles or cross-contamination—think of it like a strict kitchen hygiene and workflow plan for a factory. It matters to investors because a robust CCS reduces the risk of product recalls, production shutdowns, regulatory fines and reputational damage, all of which can materially affect revenue, costs and a company’s ability to bring products to market on schedule.

standard operating procedure (sop) technical

"includes TOMI’s comprehensive standard operating procedure (SOP) development package"

A standard operating procedure (SOP) is a written step-by-step guide that describes how an organization performs a routine task or process to ensure it is done the same way every time. For investors it signals consistency and risk control—like a recipe that helps reduce mistakes, improve quality, and make outcomes more predictable, which can protect value and support reliable growth.

installation and operational qualification (iq/oq) technical

"and Installation and Operational Qualification (IQ/OQ) package performed"

Installation and operational qualification (IQ/OQ) are documented checks that new or modified equipment is set up correctly (IQ) and then performs reliably under expected conditions (OQ). Think of it like confirming a new oven was installed level and wired properly, then baking test batches to prove it heats evenly; for investors, successful IQ/OQ reduces regulatory risk, production delays, and costly recalls, and supports consistent product quality and predictable revenue.

503b compounding regulatory

"The rapid expansion of Cell and Gene Therapy and 503B compounding is driving"

503B compounding describes the manufacture of bulk or patient-ready sterile medications by FDA-registered “outsourcing facilities” that follow higher federal quality and reporting rules than typical local pharmacies. Think of it as a licensed small factory that makes ready-to-use drugs under strict inspections and record-keeping; for investors, 503B status matters because it affects a business’s ability to sell to hospitals and clinics, its regulatory risk, and its potential revenue and liability exposure.

AI-generated analysis. Not financial advice.

FREDERICK, Md., Dec. 22, 2025 (GLOBE NEWSWIRE) -- TOMI Environmental Solutions, Inc.^® (“TOMI”) (NASDAQ: TOMZ), a global leader in disinfection and decontamination solutions, announced today that a leading Cell and Gene Therapy (CGT) manufacturer has adopted SteraMist ionized Hydrogen Peroxide (iHP) technology for its commercial-scale facility. This multi-staged implementation strengthens the facility’s Contamination Control Strategy (CCS) to meet the rigorous current Good Manufacturing Practices (cGMP) requirements for developing novel genetic disease therapies.

The client has invested in multiple SteraMist systems to facilitate surface treatment and automated room fogging, ensuring the highest standards and safety. To provide a seamless transition to commercial production, the partnership includes TOMI’s comprehensive standard operating procedure (SOP) development package and Installation and Operational Qualification (IQ/OQ) package performed by the TOMI Qualification Team.

"This collaboration reflects the continued adoption of SteraMist iHP technology across the biopharmaceutical sector, particularly in the rapidly evolving Cell and Gene Therapy market," said James Cherrey, TOMI’s Director of Product Compliance and Manufacturing. “As CGT manufacturers transition from development to commercial-scale production, there is an increasing need for validated, scalable contamination control solutions. This multi-stage implementation demonstrates our ability to support that progression with a comprehensive, turnkey approach that aligns with cGMP requirements and long-term operational needs.”

To reset the laboratory space to an operational environment, TOMI’s iHP Corporate Service team will perform a comprehensive whole-facility fogging service. This service covers all critical areas, including manufacturing suites, quality control labs, and support spaces, ensuring the environment is sterile for critical pharmaceutical processes.

The rapid expansion of Cell and Gene Therapy and 503B compounding is driving a critical need for next-generation sterilization. TOMI remains at the forefront of this shift, providing specialized expertise and scalable solutions tailored to the stringent requirements of these high-growth sectors.

About TOMI™ Environmental Solutions, Inc.: Innovating for a safer world®

TOMI™ Environmental Solutions, Inc. (NASDAQ:TOMZ) is a global decontamination and infection prevention company, providing environmental solutions for indoor surface disinfection through the manufacturing, sales and licensing of its premier Binary Ionization Technology® (BIT™) platform. Invented under a defense grant in association with the Defense Advanced Research Projects Agency (DARPA) of the U.S. Department of Defense, BIT™ solution utilizes a low percentage Hydrogen Peroxide as its only active ingredient to produce a fog of ionized Hydrogen Peroxide (iHP™). Represented by the SteraMist® brand of products, iHP™ produces a germ-killing aerosol that works like a visual non-caustic gas.

TOMI products are designed to service a broad spectrum of commercial structures, including, but not limited to, hospitals and medical facilities, cruise ships, office buildings, hotel and motel rooms, schools, restaurants, meat and produce processing facilities, military barracks, police and fire departments, and athletic facilities. TOMI products and services have also been used in single-family homes and multi-unit residences.

TOMI develops training programs and application protocols for its clients and is a member in good standing with The American Biological Safety Association, The American Association of Tissue Banks, Association for Professionals in Infection Control and Epidemiology, Society for Healthcare Epidemiology of America, America Seed Trade Association, and The Restoration Industry Association.

For additional information, please visit https://www.steramist.com or contact us at info@tomimist.com.

Forward-Looking Statements

This press release contains forward-looking statements that are based on current expectations, estimates, forecasts and projections of future performance based on management’s judgment, beliefs, current trends, and anticipated product performance. These forward-looking statements include, without limitation, statements relating to TOMI’s products and services to serve the life science sector. Forward-looking statements involve risks and uncertainties that may cause actual results to differ materially from those contained in the forward-looking statements. These factors include, but are not limited to, our ability to acquire new customers and expands sales; our ability to maintain and manage growth and generate sales, our reliance on a single or a few products for a majority of revenues; the general business and economic conditions; and other risks as described in our SEC filings, including our Annual Report on Form 10-K for the fiscal year ended December 31, 2024 filed by us with the SEC and other periodic reports we filed with the SEC. The information provided in this document is based upon the facts and circumstances known at this time. Other unknown or unpredictable factors or underlying assumptions subsequently proving to be incorrect could cause actual results to differ materially from those in the forward-looking statements. Although we believe that the expectations reflected in the forward-looking statements are reasonable, we cannot guarantee future results, level of activity, performance, or achievements. You should not place undue reliance on these forward-looking statements. All information provided in this press release is as of today’s date, unless otherwise stated, and we undertake no duty to update such information, except as required under applicable law.

INVESTOR RELATIONS CONTACT:  

John Nesbett/Rosalyn Christian  

IMS Investor Relations  

tomi@imsinvestorrelations.com  

FAQ

What did TOMI (NASDAQ: TOMZ) announce on December 22, 2025 about SteraMist iHP?

TOMI announced a multi-stage SteraMist iHP implementation at a commercial-scale Cell and Gene Therapy manufacturing site, including systems, SOP development, and IQ/OQ support.

How will TOMI’s SteraMist systems be used at the new CGT facility (TOMZ)?

The systems will provide surface treatment and automated room fogging across manufacturing suites, quality control labs, and support spaces to support contamination control.

Does the TOMI (TOMZ) engagement include validation and qualification services?

Yes. The engagement includes a standard operating procedure package and an Installation and Operational Qualification (IQ/OQ) performed by TOMI’s Qualification Team.

Will TOMI (TOMZ) provide onsite fogging services at the new pharmaceutical site?

Yes. TOMI’s iHP Corporate Service team will perform comprehensive whole-facility fogging to reset the laboratory and critical areas to an operational environment.

What manufacturing standards does TOMI (TOMZ) say the SteraMist iHP implementation supports?

TOMI says the multi-stage implementation is designed to align with current Good Manufacturing Practices (cGMP) requirements for commercial-scale CGT production.

What parts of the facility are covered by TOMI’s contamination control services (TOMZ)?

Services cover critical areas including manufacturing suites, quality control laboratories, and support spaces as part of the contamination control strategy.