OTC: PURE
PURE BIOSCIENCE, INC.CIK 0001006028 · SIC 2890 · Industrial & Miscellaneous Chemicals
We are dedicated to developing and commercializing proprietary antimicrobial products that address health and environmental challenges related to pathogen and hygienic control. Our technology platform is based on patented stabilized ionic silver, and our initial products contain Silver Dihydrogen… About this business →
Every 8-K is open in full. Other 10-Ks and 10-Qs show a 3-bullet preview. A free account reads 3 more full reports a month. Generating a report requires a verified account.
Sign up freeWant to see a complete report first? Today's free report (FUL 10-Q) is open in full — no account needed.
Summary not yet generated.
Summary not yet generated.
Partner
Trade PURE commission-free
Open an account, get a free stock.
Investing involves risk. Free stock terms apply.
Summary not yet generated.
Summary not yet generated.
Summary not yet generated.
Summary not yet generated.
Summary not yet generated.
Summary not yet generated.
Summary not yet generated.
Summary not yet generated.
Summary not yet generated.
Summary not yet generated.
Summary not yet generated.
Summary not yet generated.
Summary not yet generated.
Summary not yet generated.
Summary not yet generated.
Summary not yet generated.
Summary not yet generated.
Summary not yet generated.
Summary not yet generated.
Latest financial statements
From 10-K filed Oct 29, 2026 (period ending Jul 31, 2026). As printed on the EDGAR/iXBRL face — not generated by the model.
Consolidated Statements of Operations
| Description | Years ended July 31, 2026 | Years ended July 31, 2025 |
|---|---|---|
| Net product sales | 2,315,000 | 2,198,000 |
| Royalty revenue | 3,000 | 4,000 |
| Total revenue | 2,318,000 | 2,202,000 |
| Cost of goods sold | 992,000 | 899,000 |
| Gross Profit | 1,326,000 | 1,303,000 |
| Operating costs and expenses | ||
| Selling, general and administrative | 3,077,000 | 3,259,000 |
| Research and development | 332,000 | 316,000 |
| Total operating costs and expenses | 3,409,000 | 3,575,000 |
| Loss from operations | (2,083,000) | (2,272,000) |
| Other income (expense) | ||
| Interest expense, net | (407,000) | (299,000) |
| Other income (expense), net | 7,000 | 172,000 |
| Total other income (expense) | (400,000) | (127,000) |
| Net loss | (2,483,000) | (2,399,000) |
| Basic and diluted net loss per share | (0.02) | (0.02) |
| Shares used in computing basic and diluted net loss per share | 116,456,503 | 111,862,884 |
Consolidated Balance Sheets
| Description | July 31, 2026 | July 31, 2025 |
|---|---|---|
| Assets | ||
| Current assets | ||
| Cash and cash equivalents | 569,000 | 334,000 |
| Accounts receivable | 334,000 | 474,000 |
| Inventories, net | 193,000 | 141,000 |
| Restricted cash | 75,000 | 75,000 |
| Prepaid expenses | 14,000 | 23,000 |
| Total current assets | 1,185,000 | 1,047,000 |
| Property, and equipment, net | 8,000 | 11,000 |
| Total assets | 1,193,000 | 1,058,000 |
| Liabilities and stockholders’ deficiency | ||
| Current liabilities | ||
| Accounts payable | 820,000 | 784,000 |
| Convertible notes payable to related parties, current (including $1,015,000 and $0, respectively, past due) | 3,381,000 | 1,175,000 |
| Accrued liabilities | 170,000 | 154,000 |
| Total current liabilities | 4,371,000 | 2,113,000 |
| Convertible notes payable to related parties non-current | 3,221,000 | 4,061,000 |
| Total liabilities | 7,592,000 | 6,174,000 |
| Commitments and contingencies | ||
| Stockholders’ deficiency | ||
| Preferred stock, $0.01 par value: 5,000,000 shares authorized, no shares issued and outstanding | — | — |
| Common stock, $0.01 par value: 250,000,000 and 200,000,000 shares authorized at July 31, 2026 and July 31, 2025, respectively, 130,017,569 shares issued and outstanding at July 31, 2026, and 111,886,473 shares issued and outstanding at July 31, 2025 | 1,301,000 | 1,119,000 |
| Additional paid-in capital | 133,777,000 | 132,759,000 |
| Accumulated deficit | (141,477,000) | (138,994,000) |
| Total stockholders’ deficiency | (6,399,000) | (5,116,000) |
| Total liabilities and stockholders’ deficiency | 1,193,000 | 1,058,000 |
Consolidated Statements of Cash Flows
| Description | Years ended July 31, 2026 | Years ended July 31, 2025 |
|---|---|---|
| Operating activities | ||
| Net loss | (2,483,000) | (2,399,000) |
| Adjustments to reconcile loss to net cash used in operating activities: | ||
| Share-based compensation | 197,000 | 147,000 |
| Depreciation and amortization | 3,000 | 2,000 |
| Changes in operating assets and liabilities: | ||
| Accounts receivable | 140,000 | (176,000) |
| Inventories | (52,000) | (85,000) |
| Prepaid expenses | 9,000 | 4,000 |
| Accounts payable and accrued liabilities | 52,000 | 205,000 |
| Interest on note payable | 396,000 | 287,000 |
| Net cash used in operating activities | (1,738,000) | (2,015,000) |
| Financing activities | ||
| Net proceeds from private placement | 1,003,000 | — |
| Net proceeds from convertible notes payable to related parties | 970,000 | 2,000,000 |
| Net cash provided by financing activities | 1,973,000 | 2,000,000 |
| Net increase (decrease) in cash, cash equivalents, and restricted cash | 235,000 | (15,000) |
| Cash, cash equivalents, and restricted cash at beginning of year | 409,000 | 424,000 |
| Cash, cash equivalents, and restricted cash at end of year | 644,000 | 409,000 |
| Reconciliation of cash, cash equivalents, and restricted cash to the consolidated balance sheets | ||
| Cash and cash equivalents | 569,000 | 334,000 |
| Restricted cash | 75,000 | 75,000 |
| Total cash, cash equivalents and restricted cash | 644,000 | 409,000 |
| Supplemental disclosure of cash flow information | ||
| Cash paid for taxes | 5,000 | 3,000 |
Amounts as printed on the EDGAR/iXBRL face. Labels, columns, and figures are the filing face, not a GAAP stencil. Interactive statements & notes on EDGAR ↗
About PURE BIOSCIENCE, INC.
Source: Item 1 (Business) from the 10-K filed October 29, 2026. Description as filed by the company with the SEC.
Item
1. Business
Overview
We
are dedicated to developing and commercializing proprietary antimicrobial products that address health and environmental challenges related
to pathogen and hygienic control. Our technology platform is based on patented stabilized ionic silver, and our initial products contain
Silver Dihydrogen Citrate, or SDC. This broad-spectrum, non-toxic antimicrobial agent is available in liquid form and various concentrations,
distinguished by its superior efficacy, reduced toxicity, non-causticity, and the inability of bacteria to develop resistance.
Our
SDC-based disinfecting and sanitizing products are registered with the United States Environmental Protection Agency, or EPA, the United
States Food and Drug Administration, or FDA, and Health Canada. In addition to manufacturing and distributing these products, we also
supply SDC-based formulations as raw material ingredients for personal care products.
We
see significant market opportunities for our safe and effective SDC-based solutions, particularly in the food industry. Our registered
offerings include PURE® Hard Surface, a food contact surface sanitizer and disinfectant designed for restaurant chains, food processors,
and transportation companies, as well as PURE Control®, a direct food contact processing aid. Our products are sold directly to end-use
customers, as well as third-party distributors who market and sell our products across various industries, maximizing our reach and impact.
Technology
Platform
Read full description ↓
Silver
as an Antimicrobial
Our
patented molecule, SDC, represents one of the first significant advancements in antimicrobials in decades. SDC is an electrolytically
generated source of stabilized ionic silver, making it a versatile foundation for a variety of products across diverse markets. Colorless,
odorless, tasteless and non-caustic, the aqueous SDC formulates well with other compounds. We produce and market pre-formulated, ready-to-use
product, as well as varying strengths of SDC concentrate as an additive or raw material for inclusion in other products.
Stability
SDC
is a stabilized silver ion complex with a shelf life of several years. The unique bond between the silver ion in SDC allows the silver
ion to remain in solution while at the same time making it more bio-available for antimicrobial action.
Mode
of Action
SDC
kills microorganisms by two modes of action: 1) the silver ion deactivates structural and metabolic membrane proteins leading to microbial
death; and 2) the microbes view SDC as a food source, allowing the silver ion to enter the microbe. Once inside the organism, the silver
ion denatures the deoxyribonucleic acid, or DNA, which halts the microbe’s ability to replicate and leads to its death. This dual
action makes SDC highly and quickly effective against a broad spectrum of microbes.
4
Safety
and Toxicity Categories
SDC
is non-toxic, non-caustic, colorless, odorless, tasteless and does not produce toxic fumes. While SDC is highly toxic to bacteria, fungi
and viruses it is non-toxic to humans and animals. Based on the EPA toxicity categorization of antimicrobial products at use dilutions,
that range from Category I (high toxicity) down to Category IV (no/low toxicity), SDC is rated in the lowest toxicity category, Category
IV, while traditional disinfectants fall into Categories I and II.
The
following table shows the EPA toxicity categories and required signal words.
Toxicity
Category
Signal
Word
I
DANGER, POISON
II
WARNING
III
CAUTION
IV
None required
PURE®
Hard Surface is a Category IV product for which no signal words are required.
Limitations
of Existing Food Safety Solutions
The
United States, or U.S., food industry continues to rely on the use of toxic chemicals as processing aids or interventions during food
processing operations for which pathogens are becoming increasingly resistant and rendering current interventions less efficacious. Most
of these chemicals carry various warning labels for their toxic and/or caustic characteristics, which can negatively affect the safety
of processing plant personnel, plant operating equipment and the plant environment and its surroundings.
Currently
used chemicals in food processing include peracetic acid, acidified sodium chlorite, ozone, and chlorine dioxide. Some of these chemicals
can be difficult to work with as a processing aid as they require heating to become effective or are difficult to mix and stabilize prior
to use. Some of these chemicals damage the food being processed, leading to reduced yields and their effectiveness is often limited to
specific pathogens or foods. Additionally, some of these chemicals can produce noxious fumes that over time have been linked to upper
respiratory illness and typically require in-plant decontamination of their effluence.
Natural
and Environmentally Responsible
SDC
is made of simple and all-natural ingredients: water, citric acid and minute amounts of ionic silver. SDC does not present a threat to
the environment. If introduced to wastewater systems, the low concentrations of ionic silver in SDC would react with naturally present
substances such as chlorides, sulfides and organic matter. These reactions would create insoluble silver complexes and render the silver
inert. In addition, SDC is manufactured through a “zero waste” process in which no byproducts or environmental effluent are
created.
5
Business
Strategy
Our
goal is to establish a sustainable company by commercializing SDC-based products developed through our proprietary technology platform.
We aim to deliver leading antimicrobial solutions that tackle food safety risks across the entire food industry supply chain. Our products
are sold directly to end-use customers and through our expanding distribution network. Key elements of our business strategy include:
1.
Growing and supporting
our distribution network. Expanding sales through distribution provides the following:
a.
Expanded Reach: Distributors
often have established networks and customer relationships, allowing us to access new markets and customer segments more efficiently.
b.
Cost Savings: Utilizing
distributors can reduce overhead costs associated with logistics, warehousing, and inventory management.
c.
Market Knowledge: Distributors
typically have local market insights and expertise, helping us navigate regional preferences and regulatory requirements.
d.
Faster Time to Market:
Distributors can accelerate product availability in geographic regions throughout the country, enabling quicker responses and shortening
the sales cycle.
e.
Sales Support: Distributors
provide additional sales resources and support, such as training and promotional activities, enhancing product visibility.
f.
Scalability: Distributors
can easily scale operations to accommodate growth without requiring significant investment from the manufacturer.
g.
Customer Service: Local
distributors can offer better customer support, including faster response times and tailored services to meet specific client needs.
2.
Continuing to partner with
third parties seeking, or intending to seek, approvals to market SDC-based products outside the U.S.
3.
Developing additional proprietary
products and applications.
4.
Protecting and enhancing
our intellectual property.
In
addition to our existing food safety products, we plan to leverage our technology platform through licensing and distribution collaborations
to create new products and explore additional markets, aiming to generate multiple revenue streams.
Our
Products
PURE®
Hard Surface Disinfectant and Sanitizer (Ready to Use)
PURE
Hard Surface is our SDC-based, patented, and EPA-registered ready-to-use hard surface disinfectant and food contact surface sanitizer.
Combining high efficacy with low toxicity, it achieves bacterial and viral kill times in as few as 30 seconds. The product effectively
kills resistant pathogens such as MRSA and NDM-1, as well as dangerous fungi and viruses including SARS Co-V-2, HIV, Hepatitis B, Hepatitis
C, Norovirus, Influenza A, Avian Influenza, and H1N1. Additionally, it eradicates hazardous food pathogens like E. coli, Salmonella,
Campylobacter, and Listeria, all while being classified as least-toxic by the EPA.
Formulated
for ease of use, PURE Hard Surface contains no bleach, ammonia, phosphates, phenols, or Volatile Organic Compound-emitting compounds,
and features an odorless, non-caustic, and non-irritating formula that enhances user experience. Sanitizing and disinfecting is straightforward,
as there is no requirement to rinse the surface after application. For facilities utilizing PURE’s application systems, one gallon
of PURE Hard Surface can cover up to 40,000 cubic feet, effectively reducing the risk of cross-contamination from treated surfaces. The
product also ensures a rapid disinfectant kill time of 30 to 120 seconds for bacteria and viruses, with no personal protective equipment,
or PPE required.
6
PURE
Hard Surface SDC3A Registration
The
EPA registration for SDC3A, marketed as PURE Hard Surface, includes the following efficacy claims:
Organisms
Kill
Time
Pseudomonas aeruginosa, Salmonella enterica, HIV
type 1, Rotavirus, Human Coronavirus, Influenza A (H1N1), Swine Influenza A (H1N1), Respiratory Syncytial Virus, Adenovirus Type
2, Avian Influenza A, Influenza A, SARS –CoV-2 (COVID-19 virus)
30 Seconds
Hepatitis B Virus (HBV), Hepatitis C Virus (HCV), Murine
Norovirus, Norovirus, Herpes Simplex Type 1, Rhinovirus, Polio Type 2
60 Seconds
Staphylococcus aureus, Listeria monocytogenes, Vancomycin
resistant Enterococcus faecium (VRE), Methicillin resistant Staphylococcus aureus (MRSA), Community Associated Methicillin resistant
Staphylococcus aureus (CA-MRSA), Community Associated Methicillin resistant Staphylococcus aureus (CA-MRSA-PVL), Escherichia coli
O157:H7, Acinetobacter baumannii, Campylobacter jejuni, Carbapenem resistant Escherichia coli, Carbapenem resistant Klebsiella pneumonia,
NDM-1 +,
120 seconds
Trichophyton mentagrophytes (Athlete’s Foot Fungus)
5 Minutes
PURE
Control®
PURE
Control® has been approved by the FDA for poultry processing, Food Contact Notification, or FCN 1768 and produce processing FCN 1600.
Leveraging the superior efficacy and safety of SDC, PURE Control effectively eliminates pathogens such as Salmonella, E. coli, and Listeria.
For produce, PURE Control quickly reduces pathogens on treated items, minimizes the risk of cross-contamination, enhances subsequent
intervention steps and does not affect the texture, taste, or color of the produce. For poultry, PURE Control has no effect on organoleptic
or nutritional composition, demonstrates superior efficacy with up to a 6 log reduction in Salmonella on treated products, and has no
impact on yield. No label declaration is required for PURE Control application on produce or poultry. In addition, the use of PURE Control
improves worker safety due to its odorless and non-toxic nature.
Additional
SDC-Based Products
In
addition to PURE Hard Surface and PURE Control, we manufacture and sell (i) SDC-based products for end use, (ii) products preserved with
SDC, and (iii) SDC as a raw material ingredient for manufacturing use. These products include:
PURE®
Multi-Purpose Hi-Foam Cleaner Concentrate (End-User Dilutable)
PURE®
Multi-Purpose Hi-Foam Cleaner Concentrate is an environmentally friendly, professional-grade cleaning product that features a high foaming
formulation. It is safe for both users and the environment, being free from toxic preservatives, EDTA, phosphates, ammonia, bleach, Volatile
Organic Compounds, or VOCs, and Nonylphenol Ethoxylates. The concentrate is designed for multiple dilution ratios and can be used on
a variety of surfaces, including stainless steel, floors, walls, and painted areas.
This
economical cleaner produces long-lasting, high-density foam that rinses easily without leaving a residue. It complements PURE® Hard
Surface disinfectant and is suitable for food processing facilities and commercial kitchens. The product is enhanced with SDC, our non-toxic
antimicrobial that ensures safety and quality while being non-corrosive and non-irritating. It effectively cleans food and non-food contact
surfaces, including processing equipment and various other surfaces like glass, mirrors, sealed marble, and wood.
PURE®
Multi-Purpose and Floor Cleaner
PURE®
Multi-Purpose and Floor Cleaner is designed to complement the effectiveness of PURE® Hard Surface disinfectant and food contact surface
sanitizer, making it suitable for sanitation in food processing plants, commercial kitchens, healthcare facilities, schools, and hospitality
settings where high foam is not desirable.
This
economical concentrate is easy to use manually or in floor scrubbers and rinses off without leaving a residue. It can be diluted to meet
various cleaning needs. The cleaner is non-toxic and environmentally friendly, free from EDTA, phosphates, ammonia, bleach, and VOCs.
Additionally, it contains SDC, our non-toxic antimicrobial that ensures safety and quality without harmful preservatives.
SILVÉRION®
(Raw Material Ingredient)
SILVÉRION
is our patented SDC-based antimicrobial formulation for use as a raw material ingredient in the manufacturing of personal care products.
It can be used as either an active ingredient or a preservative. SILVÉRION is a colorless, odorless and stable solution that provides
ionic silver in a water-soluble form. It provides fast acting efficacy at low concentrations against a broad-spectrum of bacteria, viruses,
yeast and molds. SILVÉRION is currently sold domestically and outside of the United States in various personal care products.
7
Industries
we serve
Food
processing – Harvesting equipment, grow barns and processing facilities
We
understand that no two facilities are alike, therefore, we work with distribution partners and end-use customers to solve their unique
needs related to contamination prevention and control. Our products offer specialized industry solutions that can effectively reduce
food processing risks while optimizing operational efficiency.
Our
patented SDC molecule enables us to create powerful products without harsh chemicals like bleach, ammonia, or VOCs, making them safe
for use in food processing facilities without the need for specialized personal protective equipment. Our non-corrosive surface products
are designed to protect equipment and machinery and can be applied to both food and non-food contact surfaces, including processing equipment,
spiral freezers, belts, conveyors, walls, floors, drains, and piping systems. Our SDC molecule provides added protection against corrosion
and staining, ensuring food processing plants remain clean and compliant. Additionally, our products are designed to optimize resource
use by reducing water consumption, minimizing waste, conserving time and labor, and limiting the introduction of harsh chemicals into
the environment.
Products
for the food processing industry – PURE Hard Surface, PURE Multi-Purpose Cleaner, PURE Hi-Foam Cleaner and PURE Control
Food
service and hospitality – Restaurants, quick-serve restaurants, hotels and supermarkets
The
use of PURE Hard Surface has demonstrated dramatic improvement in sanitation compared to traditional quaternary ammonia based sanitizers
in a variety of food service operations. In-store field testing of PURE Hard Surface on critical food contact areas resulted in an impressive
96% improvement in efficacy - leading to a significant reduction in food safety risk. Employees consistently expressed preference for
PURE Hard Surface’s attributes including its ease of use, odorless scent, and lack of skin irritation.
Products
for food service and hospitality – PURE Hard Surface and PURE Multi-Purpose Cleaner
Healthcare
– Hospitals, assisted living facilities and clinics
PURE
Hard Surface meets Occupational Safety & Health Administration blood-borne pathogen guidelines, kills multiple drug-resistant organisms,
and is ideal for use as a disinfectant in multiple healthcare settings.
Products
for healthcare - PURE Hard Surface, PURE Multi-Purpose Cleaner and PURE Hi-Foam Cleaner
Facility
care - Childcare, education, office and commercial buildings
We
recognize that proper facility care is paramount, especially in daycares, schools, gyms, and office spaces. Our SDC-based products make
cleaning and sanitizing quick and easy, so customers can be sure their facilities are meeting the highest safety standards. By partnering
with our customers, we offer customizable implementation plans to support their contamination prevention program.
Products
for facility care – PURE Hard Surface, PURE Multi-Purpose & Floor Cleaner
Transportation
– Ground, rail, air and water
In
conjunction with our application system partner, we have developed a simple, time-efficient solution to transport sanitization using
PURE Hard Surface. Our Pure Transport Sanitization System offers full coverage sanitation for motor and rail vehicle application. Each
refrigeration unit and air ducting is treated with every use, ensuring comprehensive cleanliness without adding water to the transport
container. This system significantly reduces trailer downtime, taking only minutes instead of hours, and can provide up to a 5 log pathogen
reduction, making it highly effective. Additionally, the system is non-corrosive, odorless, and non-caustic, requiring no pre-mixing
before use or post-rinsing, even on food contact surfaces. Our system ensures full coverage for all motor and rail vehicles, and is in
compliance with the new Food Safety Modernization Act, rule.
8
Products
for transportation - PURE Hard Surface, and PURE Hi-Foam Cleaner
Personal
care – SDC use in manufacturing of personal care products
Our
patented SDC-based technology, SILVÉRION® 2400, is an effective preservative and versatile antimicrobial solution. It combats
a wide range of microorganisms without the use of parabens, formaldehyde, halogens, or quats, making it suitable for a vast array of
personal care applications.
Products
for personal care - SILVÉRION 2400
Intellectual
Property
We
actively protect our technology, inventions, and improvements through patents, trademarks, and trade secrets. We currently hold twelve
U.S. patents. We intend to focus our future patent prosecution and defense efforts primarily to North America, Europe, Asia and Mexico.
Although
we believe that we have developed our technology independently and have not infringed, and do not infringe, on the patents of others,
third parties may make claims that our technology does infringe on their patents or other intellectual property. In the event of infringement,
we may, under certain circumstances, be required to modify our infringing product or process or obtain a license. We may not be able
to do either of those things in a timely manner if at all, and failure to do so could have a material adverse effect on our business.
In addition, we may not have the financial or other resources necessary to enforce a patent infringement or proprietary rights violation
action or to defend ourselves against such actions brought by others. If any of the products we develop infringe upon the patent or proprietary
rights of others, we could, under certain circumstances, be enjoined or become liable for damages, which would have a material adverse
effect on our business. We also use confidentiality and nondisclosure agreements to safeguard proprietary information but recognizes
the risk of breaches or inadequacies in these agreements.
Additionally,
the Company holds registered trademarks for several brands, including PURE Bioscience®, PURE®, SILVÉRION®, Powered
by SDC Ag+® and PURE Control®. Some previously held trademarks have been abandoned as they no longer align with the Company’s
strategy.
Research
and Development
We
prioritize innovation as a key element of our business strategy and long-term success. We aim to leverage our technology platform to
create additional proprietary products and applications, including both end-use products and raw material formulations. Most research
and development activities are conducted in-house, complemented by independent testing from third-party laboratories. We also collaborate
with development partners who invest in specific product and process research using our SDC technology.
Sales
and Marketing
A
critical aspect of our business strategy is to leverage the industry experience of our internal sales force, the members of our Board
of Directors, or Board, and our management team in order to maximize the commercial potential of our technology platform in the food
industry. We are also working in tandem with numerous distribution partners to service existing customers and secure new customers.
Additionally,
we plan to form selective partnerships with industry leaders to enhance product commercialization both domestically and internationally,
leveraging partners’ resources for broader market reach. We believe our SDC-based products offer superior pathogen control compared
to traditional chemical solutions, which often have higher toxicity.
9
Sales
Concentration
Net
product sales were $2,315,000 and $2,198,000 for the fiscal year ended July 31, 2026 and 2025, respectively. The increase of $117,000
was attributable to increased sales across our end-user network servicing the food processing industry. Our top three customers accounted
for $824,000 of net product sales for the fiscal year ended July 31, 2026. For
the year ended July 31, 2026, one customer accounted for 24% of our net product sales. No other individual customer accounted for 10%
or more of our net product sales. There were no foreign sales during the fiscal year ended July 31, 2026.
From
time to time, one or a small number of our customers may represent a significant percentage of our revenue. Our largest customer accounted
for 24% of our revenue for the fiscal year ended July 31, 2026. Although we have agreements with many of our customers, these agreements
typically do not prohibit customers from purchasing products and services from competitors. A decision by any of our major customers
to significantly reduce the amount of product ordered or license fees paid, or their failure or inability to pay amounts owed to us in
a timely manner, or at all, could have a significant adverse effect on our business.
Competition
Since
SDC is a novel antimicrobial technology, our success hinges on gaining market share from established products. Even if SDC demonstrates
technological advantages, substantial investments are needed to displace traditional technologies offered by well-known industry leaders.
Moreover,
SDC-based products, particularly those with higher silver ion concentrations, are generally more expensive to produce than existing chemicals,
which may deter customers from purchasing them, despite their superior efficacy. Customers may also find that the benefits of SDC products
(such as being non-toxic and non-caustic) are insufficient to justify the higher costs compared to lower-priced alternatives.
Government
Regulation
Our
business is subject to various government regulations relating to the protection of public health and the environment. Among these are
laws that regulate the manufacture, storage, distribution and labeling of our products, as well as the use, handling, storage and disposal
of certain materials in the manufacturing of our products.
Requirements
Imposed by the EPA and Similar State Agencies
We
manufacture and sell in the U.S. certain disinfecting products that kill or reduce microorganisms (bacteria, viruses, fungi). The manufacture,
labeling, handling and use of these products are regulated by the EPA under the Federal Insecticide, Fungicide, and Rodenticide Act,
or FIFRA. We currently sell three products registered by the EPA under FIFRA, certain of which are approved for use on food contact surfaces
and others of which are approved for use on non-food contact hard surfaces. EPA product registration requires meeting certain efficacy,
toxicity and labeling requirements and paying ongoing registration fees.
Although
states do not generally impose substantive requirements different from those of the U.S. EPA, each state in which our products are sold
requires registration and payment of a fee. California and certain other states have adopted additional regulatory programs applicable
to these types of products that, in some cases, impose a fee on total product sales in the state.
Based
on our experience and our knowledge of current trends, we expect the costs and delays in receiving necessary federal and state approvals
for these types of products may increase in the coming years.
Requirements
Imposed by Ingredient Legislation
Numerous
federal, state and local laws regulate the sale of products containing certain identified ingredients that may impact human health and
the environment. For instance, California has enacted Proposition 65, which requires the disclosure of specified listed ingredient chemicals
on the labels of products. Although none of the ingredients in our current products are reportable under Proposition 65, this and other
similar legislation may become more comprehensive in the future and/or new products we may develop could be subject to these regulations.
10
Requirements
Imposed by Other Environmental Laws
A
number of federal, state and local environmental, health and safety laws govern the use, handling, storage and disposal of certain materials.
Our current manufacturing process for SDC-based products is a “zero waste” process, meaning that no byproducts are created,
and we do not use hazardous materials, as defined by applicable environmental laws, in the manufacturing of these products. As such,
some of these U.S. environmental laws are not generally applicable to us in their current form. However, these laws may in the future
identify, as hazardous materials certain materials that we use in our manufacturing processes, or we may opt to or be forced to change
our manufacturing procedures in a way that subjects our products or operations to these laws.
Requirements
Imposed by the U.S. FDA and USDA
Various
laws and regulations have been enacted by federal, state, local and foreign jurisdictions regulating certain products we manufacture
and sell for controlling microbial growth in or on foods. In the United States, these requirements generally are administered by the
FDA. However, the USDA and EPA also may share in regulatory jurisdiction of antimicrobials applied directly to food as it pertains to
poultry and meats.
Regulation
Outside the United States
The
commercialization of SDC-based products in countries other than the U.S. may require that we, or companies with whom we partner for such
foreign commercialization, obtain necessary approvals from foreign regulatory authorities comparable to the EPA, FDA and USDA, among
others. Applicable approval processes and ongoing requirements vary from country to country and may involve more time and expense than
that required to obtain approvals in the U.S. In international markets, we currently sell our products under active registrations held
by us, or by our distributors. We intend to continue to process registrations ourselves or through distributors as required.
We
currently hold a registration from Health Canada for our disinfectant product. We also have received a Letter of No Objection from Health
Canada for our antimicrobial food processing aid on fruits and vegetables intended for processing. Additionally, an opinion has been
granted under the Scientific Committee on Consumer Products to sell SDC in the European Union for use in cosmetics, which includes personal
care products.
Human
Capital
As
of October 29, 2026, we have 10 full-time employees and 1 part-time employee. We believe we have successfully attracted skilled and experienced
talent; however, the competition for qualified personnel is fierce, and we cannot guarantee our ability to retain or attract them in
the future. None of our employees are part of collective bargaining agreements, and we maintain positive relations with our team. We
are committed to fostering a culture that promotes the values, behaviors, and attributes essential for advancing our business and executing
our strategy.
Company
Information
We
were incorporated in the state of California in August 1992 as Innovative Medical Services. In September 2003, we changed our name to
PURE Bioscience. In March 2011, we reincorporated in the state of Delaware under the name “PURE Bioscience, Inc.”
Our
mailing address is 771 Jamacha Road, #512, El Cajon, California 92019. Our executive officers and employees work remotely in a “virtual
office” setting without lease obligations. Our telephone number is (619) 596-8600. Our website address is www.purebio.com. We make
available free of charge on our website our periodic and current reports, proxy statements and other information as soon as reasonably
practicable after such reports are filed with the SEC. Information contained on, or accessible through, our website is not part of this
report or our other filings with the SEC. Our SEC filings are also available to the public from the SEC’s website at www.sec.gov.