COMPANY INTRODUCTION 2019

BiosafeDefenses.com

Andy Pham Managing Member Email: andy@BiosafeDefenses.com Phone: (800) 488-2909

Biosafe Defenses, LLC Cecci VentureLab Lobo Rainforest Building 101 Broadway Blvd. NE, Suite 1100 Albuquerque, NM 87102

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PREFACE

Antibiotics are critical to the welfare of humanity. However, over the past century, the rise of antibiotic-resistant bacteria and fungi has warranted the investigation of alternative antimicrobials and decontamination strategies. For years, quaternary ammonium compounds (“quats”) were thought to be the answer, yet new information has caused the FDA to reconsider their benefits—particularly for consumer use. Fortunately, a new class of antimicrobial compound has been developed, and offers great promise in our ongoing defense against pathogenic microbes. These compounds, known as conjugated polyelectrolytes (CPEs), fundamentally differ from traditional antimicrobials in that they are “light-activated” and deal broad-spectrum damage in a detergent-like manner. Despite the promise of these compounds, there was—up until recently—good reason to believe that they were simply not suitable for use outside of the laboratory. But they are.

Over the past five years, a series of studies were carried out to address these legitimate concerns. First, the compatibility of oligomers with surfactant was investigated, and found to confer numerous biocidal benefits. Similar oligomers were found to be sporicidal and fungicidal. Polymers were also investigated and were found to be well-suited for attachment onto plastics, glasses, metals, and textiles. The culmination of these studies (over 100 papers published) foreshadows the use of these compounds as hospital-grade disinfectants and antimicrobial coatings. Biosafe Defenses, LLC is proud to be the exclusive owner of this technology, as well as the leader in commercialization of this critical class of antimicrobials. We invite your participation and financial partnership.

Sincerely,

Andy Pham Managing Member President & CEO Biosafe Defenses, LLC

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Potential Uses for our Technology

Our technology platform (11 issued patents) has endless potential applications based on antimicrobial, antiviral, antifungal, anti-biofilm properties:

Coating of Solids and Surfaces Fabrics and Fibers Additives for Existing Products • Catheters • Medical Devices • Medical Implants • Hospitals • Schools • Public Facilities • Household Surfaces • Doorknobs/Buttons • Surgical Instruments • Medical Disposables

• Bandages • Bedding/Linens • Gloves/Masks • Lab Coats • Surgical Gowns • Gauze • Towels • Wipes • Air/Water Filtration • Household Products

• Paints • Plastics • Polishes • Sealants • Soaps • Detergents • Disinfectant Sprays • Dental Products • Anti-Fungal • Dental Products

Advantages & Benefits

• Broad-spectrum activity against fungi, bacteria, and viruses

• Keeps surfaces clean for at least 24 hours

• Recommended sanitizer for non-food contact surfaces

• Provides an effective method for killing microbes

• Inhibits biofilm growth

• Eradicates biofilms with antibiotic-grade efficacy

• May be incorporated onto textiles and hard, non-porous surfaces: metals, plastics, and glass

• Functional in self-sanitizing, self-cleaning surfaces

• Effectively kills drug-resistant pathogens

• Two-pronged attack lessens likelihood of eliciting antimicrobial resistance

• Environmentally friendly degradation pathway

• Compatible with detergents and surfactants

• Non-irritating to skin

• Non-toxic to endothelial and epithelial cells

• Visual fluorescent tracking allows end-users to know when reapplication is necessary

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11 Issued Patents 1. “Surface grafted conjugated polymers.” US Patent 8,455,265, issued June 4, 2013.

2. “Materials incorporating antimicrobial polymers.” US Patent 8,598,053, issued December 3, 2013.

3. “Conjugated polyelectrolyte capsules: light activated antimicrobials.” US Patent 8,618,009, issued December 31, 2013.

4. “Structure, synthesis, and applications for oligo phenylene ethynylenes.” US Patent 8,753,570, issued June 17, 2014.

5. “Conjugated polyelectrolyte capsules: light activated antimicrobials.” US Patent 9,005,540, issued April 14, 2015.

6. “Thiophene based oligomers as light activated biocides.” US Patent 9,125,415, issued September 8, 2015.

7. “Structure, synthesis, and applications for poly (phenylene) ethynylenes (PPEs).” US Patent 9,527,806, issued December 27, 2016.

8. “Antimicrobial materials and methods.” US Patent 9,549,549, issued January 24, 2017.

9. “Conjugated polyelectrolytes and methods of using the same.” US Patent 9,750,250, issued September 5, 2017. Canada Patent 2,973,982. Europe Patent 16737889.2. South Korea Patent 10-2017-7022348. Japan Patent 2017-554255.

10. “Charged singlet-oxygen sensitizers and oppositely charged surfactants.” US Patent 14/533,612, issued January 10, 2018.

11. “Antimicrobial materials and methods.” US Patent 15/368,148, issued February 9, 2018.

4 Pending Patents 12. “Structure, synthesis, and applications for oligo phenylene ethynylenes (OPEs).” US Patent Application

13/0,273,800, filed October 17, 2013.

13. “Structure, synthesis, and applications for poly (phenylene) ethynylenes (PPEs).” US Patent Application 15/348,756, filed November 10, 2016.

14. “P-phenylene ethynylenes compounds as bioactive and detective agents.” US Patent Application 15/125,896, filed January 26, 2017.

15. “Treatment and prevention of fungal infections.” US Patent Application 15/886,469, filed February 1, 2018.

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Problems with Traditional Disinfectants In August 2017, researchers at the University of California Davis published a study on the health implications of commonly used antiseptic ingredients, such as quaternary ammonium compounds (“quats”). Surprisingly, “quats” found in toothpastes, mouthwashes, etc., were found to pose both cellular

and reproductive health concerns (see: Page 11, Appendix). Fortunately, the FDA has recently taken steps to mitigate our exposure to these compounds and others that it no longer considers to be “recognized as safe and effective.” (http://federalregister.gov/a/2016-21337) As of September 2017, 19 consumer antiseptic wash active ingredients are effectively banned by the FDA from use in consumer hand sanitizers.

“[This] amendment is part of FDA's ongoing rulemaking to evaluate the safety and effectiveness of OTC drug products marketed in the United States…the risk from the use of a consumer antiseptic wash drug product must be balanced by a demonstration—through studies that demonstrate a direct clinical benefit (i.e., a reduction of infection)—that the product is superior to washing with nonantibacterial soap and water in reducing infection…”

Benzalkonium chloride is one of the most commonly used disinfectants in the industry, and so it’s advancement from Category I to Category III is particularly surprising. Other studies pertaining to “quats” have shown that the repeated use of this compound “may be contributing to the development of microorganisms with decreased susceptibilities to antibiotics and disinfectants.” (http://mic.microbiologyresearch.org/content/journal/micro/10.1099/mic.0.029751-0) Clearly, a new disinfectant is needed.

Category I: “Generally recognized as safe and effective.” Category II: “Not generally recognized as safe and effective.” Category III: “Available data were insufficient to determine [safety and effectiveness].”

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Biosafe’s CPEs: A New Class of Antimicrobial Electron micrographs illustrate the profound impact that Biosafe’s antimicrobials have on bacteria. These amphiphilic compounds rapidly bind to and penetrate the protective membranes of microbes. Pore formation and cell content leakage occurs in a matter of seconds. Within a few minutes, cell integrity has been completely compromised to the point where the microbes can no longer survive.

Due to their ability to generate cell-damaging ROS in the presence of light, CPEs exemplify “broad-spectrum” antimicrobials in their truest sense. As a result, these compounds rapidly kill antibiotic-resistant strains of bacteria with ease, destroying pathogenic proteins and DNA in the process. The corresponding figure illustrates just how fast these compounds penetrate and perturb bacterial cell membranes.

Visualizing CPE-induced disruption of a bacterial biomembrane mimic in real-time.

Untreated E. coli

E. coli Treated

with Biosafe CPE

E. coli Treated

with Biosafe CPE

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Where We Are Today Biosafe Defenses, LLC is proud to be on the forefront of commercialization for a new class of light-enhanced

antimicrobials. Our current mission (but by no means our exclusive mission) is to provide healthcare professionals with an improved disinfecting wipe that they desperately need to maintain a safe, healthy, and infection-free environment for patients, providers and staff at all point-of-care sites throughout the US and the world. Other potential partners with us will envision literally hundreds of other uses for our antimicrobials which we can't even envision yet (such as anti-bacterial clothing, glasses, metals or coatings). The world is changing, and our multifaceted technology is the near-exclusive doorway in.

Our First Opportunity: Healthcare Problems:

• 722,000 Americans get hospital-acquired infections (HAI’s), and over 10% of cases are fatal.

• $35 billion annual costs related to HAI’s (US only).

• Current disinfectants exhibit short killing windows, irritate skin, and are odorous.

Opportunities:

• Reduced HAI claim payments by insurance companies are forcing hospitals into better solutions.

• 70% of hospitals are planning to increase their budget on disposable disinfectants.

• Only 7 bleach products have claims against both C. difficile and MRSA.

Initial Products & Services

Biosafe is using our novel antimicrobials to develop the first light-enhanced disinfecting wipe, which has:

• Broad-spectrum activity against antibiotic-resistant bacteria, viruses and fungi

• Long-lasting disinfection performance

• Real-time fluorescence indication (to discern clean areas from contaminated or uncleaned areas).

• No irritant to skin

• No odor

Time to Reapply!

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Initial Target Market Due to emerging drug-resistant strains and an aging population, demand for disinfectants has never been higher. Large multinational companies are major players in the US disinfectant manufacturing market. Biosafe’s initial target market: 1,000,000 Physician Offices & 5,000 Hospitals in US, alone.

Business Model Short-term: Register our patented compounds with the EPA; manufacture and sell antimicrobial compounds for biomedical-, food-, agricultural-, and industrial research (Academic: $9,000/g; Industrial: $13,000/g). Long-term: (1) Manufacture disinfecting wipes for hospitals and eventually consumer market. (2) Industry partnerships on multiple non-wipe applications. Always: increase the value of our company by leveraging our diverse IP.

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Meet the Team

David G. Whitten, Ph.D. Kirk S. Schanze, Ph.D.

Scientific Advisor Scientific Advisor

Co-inventor; Associate Editor of the peer-reviewed journal

ACS Applied Materials & Interfaces (AMI); Associate

Director of UNM’s Center for Biomedical Engineering.

Co-inventor; Editor-In-Chief of AMI. Published research has received 500+ citations every

year since 2005.

Andy Pham Managing Member

25 years’ experience in the venture

capital industry. Manages over $200M in funds, including pre-IPO investments in Facebook,

Twitter, and Alibaba.

Biosafe Defenses, LLC was formed as the byproduct of research conducted by two elite research laboratories at the University of New Mexico and University of Florida. It all started in 2005, when David Whitten (UNM) and Kirk Schanze (UF) collaborated to address the growing concern of biowarfare agents. Largely funded by the US Defense Threat Reduction Agency (DTRA), these two labs were the beneficiaries of millions of dollars in funding over a 10-year span. The result: the birth of a new class of synthetic antimicrobials that will revolutionize how we use and think about disinfectants.

Our mission is to provide healthcare professionals with the tools they need to maintain a safe, healthy, and infection-free environment for patients at point-of-care sites throughout the United States and abroad.

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Medical Concerns Related to Commonly Used Antiseptics 11

Biosafe's Antimicrobials 12 Changing an Industry 16

Appendix

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Medical Concerns Related to Commonly Used Antiseptics

Common Antiseptic Ingredients De-Energize Cells and Impair Hormone Response Some Disinfectants Inhibit Cell Energy and Alter Reproduction

By Trina Wood on August 22, 2017 in Human & Animal Health, University of California, Davis A new in-vitro study by University of California, Davis, researchers indicates that quaternary ammonium compounds, or “quats,” used as antimicrobial agents in common household products inhibit mitochondria, the powerhouses of the cell, as well as estrogenic functions in cells. Their findings appear online today (Aug. 22) in Environmental Health Perspectives, a publication of the National Institute of Environmental Health Sciences. Quats are used as antiseptics in toothpastes, mouthwashes, lozenges, nasal sprays, eye drops, shampoos, lotions, intravaginal spermicidal sponges and household cleaners, to name a few. “Disinfectants that we are putting on and, in our bodies, and using in our environment, have been shown to inhibit mitochondrial energy production and the cellular estrogen response,” said biochemist Gino Cortopassi in the UC Davis School of Veterinary Medicine. “This raises concern because exposure to other mitochondrial-inhibiting drugs, such as rotenone and MPTP, is associated with increased risk for Parkinson’s disease.” Quats derail energy in cells The study surveyed a collection of 1,600 compounds and drugs in household and pharmaceutical use, with multiple measures of mitochondrial function, and found that quats as a class inhibited mitochondrial function and estrogen signaling. Mitochondria are critical cell structures that generate energy. Like a train delivering its payload among stations, electrons pass through five stations of the mitochondria to produce maximal cell energy. If the train is derailed at any of those stops, it can’t deliver its payload of energy down the line for the cell to use. The group also found that quats, at the same concentrations that inhibited mitochondria, inhibited estrogen signaling in cells. Estrogen is a sex hormone responsible for secondary sexual characteristics in females. “Because exposure to quats is also interrupting the sex hormone estrogen response in cells, it could also potentially cause reproductive harm in animals or humans, and others have shown that quats cause reproductive toxicity in animals,” Cortopassi said. From cells to mammals While the work at UC Davis has been conducted in cells, not in mammals, a group of researchers at Virginia Tech accidently discovered a few years ago that quat exposure through a laboratory disinfectant caused reproductive toxicity and reduced fertility in mice. They also recently demonstrated a link between quats and neural tube birth defects in both mice and rats. “Our study in cells provides a mechanism for their observations in laboratory animals,” said Sandipan Datta, a postdoctoral scholar in Cortopassi’s laboratory. “They demonstrated that quat exposure caused reproductive toxicity in both females and males. The anti-estrogenic effects we see in cells could explain the female reproductive toxicity they observed, such as less estrus cycles and lower breeding rates.” Quats have been widely used as topical antiseptics and disinfectants since the 1940s. Other antiseptic compounds, such as triclosan, have been withdrawn from the market after research in animal models showed they may impair muscle function. Some companies have been looking to replace triclosan with quats, Cortopassi said, with the idea that they may be creating a safer product. The research demonstrates that may not be the safest alternative. Taking it to the next level Cortopassi said it’s important for his team to take this research to the next level in animal models. Additional studies are needed to determine how these chemicals may accumulate in tissues with regular use, and to understand if quat exposure affects health and disease in humans. “This paper adds to the growing number of studies which find that quats may not be as safe as previously believed,” said Terry Hrubec, associate professor at Edward Via College of Osteopathic Medicine-Virginia, and not a co-author on this study. “The fact that six out of the 10 most potent mitochondrial inhibitors were quats shows that this class of chemicals likely affects living systems. The results from this study are concerning because almost everyone is exposed to quats on a regular basis.” In addition to Cortopassi and Datta, collaborators include Gouchun He, Alexey Tomilov, Sunil Sahdeo and Michael Denison of UC Davis. Funding for this study was provided by the National Institutes of Health.

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Biosafe’s Antimicrobials

Biosafe Defenses specializes in the synthesis and application of a class of antimicrobial known as CPEs. Although CPEs resemble traditional quaternary ammonium compounds, their unique pi-conjugated backbone provides enhanced antimicrobial properties. Under specific lighting conditions, these water-soluble compounds generate cell-damaging reactive oxygen species (ROS).

Why is this significant? Because these ROS completely denature pathogenic DNA and proteins, making it extremely unlikely that pathogens can develop a resistance to these disinfectants. Below, we detail several other advantages that come with the use of our light-activated antimicrobials…

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1) 24-hour Protection. While initially effective, bleach products’ ability to kill bacteria (in this case, S.

aureus) is greatly diminished upon drying. As shown in the adjacent graph, Biosafe’s polymers retain their biocidal effects—even after drying. Thus, a single application of our compounds provides 24-hour protection, inhibiting 99.99% of bacterial growth for the entire duration. These findings were independently validated using Modified ASTM International Method E1153.

2) Predictive Kill Window. Biosafe’s antimicrobials are highly fluorescent when illuminated with a

blacklight. This attribute allows end-users to identify whether a CPE-treated surface is actively biocidal. Most traditional disinfectants exhibit a limited “kill window,” and end-users have to guess when reapplication is necessary. CPEs fluoresce to a lesser degree as they degrade over time, allowing end-users to audit any surface and quickly determine whether said surface is still working to kill bacterial, fungal, and viral pathogens.

3) Greater Capacity for Biofilm Eradication than Antibiotics. According to the National Institute of

Health, “It is now clear that bacteria in the clinical environment live more often as communities of microorganisms (biofilms) than as single cell suspensions.” These complex communities bestow additional levels of resistance against antibiotics and disinfectants, implicating them as the cause of many healthcare-acquired infections. We show the concentration of “End-Only” OPEs (EO-OPEs) necessary to prevent biofilm regrowth (quantified as the minimum biofilm eradication concentration, MBEC) is comparable, if not better, then that of a common antibiotic, Kanamycin.

0%

25%

50%

75%

100%

0 4 8 13 17 21

Bact

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l Sur

viva

bilit

y

Time Elapsed following Application of Disinfectant [hours]

Self-Sanitizing Activity of Dried Chemical Residues on Polypropylene

Biosafe PPE Clorox Bleach

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4) Better Suited for Textile-Treatment than NanoSilver. Yet another differentiating factor of CPEs is that they retain a great deal of biocidal efficacy, even after being attached to a substrate. In particular,

we have demonstrated that a textile treated with a CPE kills 90% of bacteria in one hour, and 99.9999% (6 log reduction) of bacteria in 2 hours’ time. Conversely, it takes 8 hours for nanosilver-treated textiles to kill just 90% of bacteria. Again, the discrepancies here are largely due

to the fact that p-phenylene ethynylenes are capable of generating cell-damaging ROS when light-activated.

5) Detergent Compatibility. Albeit functional in controlled environments, traditional quaternary

ammonium compounds (e.g. CPC) are neutralized in the presence of anionic detergents (e.g. SDS),

rendering them useless as biocides. Biosafe Defenses has demonstrated that our p-phenylene ethynylene compounds (e.g. E12A) completely retain their ability to kill microbes, as ROS generated upon light-activation alleviates the concern of interfering detergents. Even in the presence of anionic detergent, our cationic compounds surpass 5 log reduction in just 2 hours’ time.

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6) Highly Effective against Viruses and Fungal Yeast. Able to destroy microbes through numerous

mechanisms of biocidal action, Biosafe Defenses’ library of p-phenylene ethynylene compounds are

truly broad-spectrum antimicrobials. In addition to having the capacity to rapidly kill bacteria, p-

phenylene ethynylenes are also adept at killing pathogenic fungi and viruses. The fungal genus Candida is very prevalent in catheter-related infections, often forming hybrid biofilms that also incorporate

bacteria. Our compounds are not only effective against C. albicans, C. glabrata, and C. parapsilosis, but also against various clinical isolates obtained from the catheters of infected patients. T4- and MS2-based

viruses are also highly vulnerable to p-phenylene ethynylene antimicrobials, particularly in the presence of light.

7) Safe to Use. The cytotoxicity of many p-phenylene ethynylene compounds has been characterized

through a series of skin-irritation tests. Of all the compounds tested, all were demonstrated to be “non-

irritants” at a concentration of 50 µg mL-1. High-molecular weight p-phenylene ethynylenes are especially inert, with concentrations of 1,000 µg mL-1 failing to elicit irritating effects. These findings were recently corroborated by a 21-day mouse study, during which no irritating effects were observed on hairless mice.

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Changing an Industry

Biosafe Defenses, LLC has created a new paradigm in the antibacterial space. Our library of compounds is extensive, Patent-protected, and exhibits varying properties depending on the needs of the end-user. We

can design and synthesize these compounds per the needs of our customers. INVEST in us and co-own the

entire portfolio with us as we grow or LICENSE our compounds for specific purposes and/or within specific territorial geographies. As the global market for disinfectants is expected to grow to $300 million dollars thru 2022, the marketplace needs the new technology we offer.

1) We are superior to bleach. Why? Bleaches kill bacteria and viruses, but only when the coated

surface is wet from the bleach! When the surface dries, the killing stops, and viruses and bacteria regrow. This is a major explanation as to why infections spread. Biosafe's molecules are light-activated, meaning they keep disinfecting a coated surface even after the surface is dry, because any light activates the killing ability of coated surface. They also fluoresce under a blacklight, so you can see what area you coated, and what you missed, and which areas need to be re-coated, which hospitals can't currently see with whatever disinfectants they use.

2) Because of this, companies can completely “re-invent” their products with the introduction of

our molecules into their current product ingredient mix.

3) Due to health concerns, toothpastes, soaps, shampoos, and mouthwashes now containing “quats” may likely need to be re-formulated, and our CPEs offer manufacturers the opportunity to make that change relatively quickly and effectively, upon EPA approval.

4) We also have Patents for using our CPE technology in fabrics (think germ-killing clothing), on

surfaces of glass (think cellphones or monitors), plastics (think the pull-down food trays of an airplane seat), on metals (think germ-killing surgical instruments), and in bandages and wipes—just to name a few areas under patent protection.

5) Royalty opportunities are plentiful, and welcome! Our CPE technology can cover royalties by

geography (i.e., by specific country, or entire regions of the world); by end use (a royalty for coating just plastics, for example, or just metals); or by product (wet wipes, bandages, toothpaste, clothing, etc.).

6) Of course, the obvious opportunity is manufacturing our CPE molecules in liquid form under

license, to be sold in containers to medical and research institutions worldwide, and for home use as well.

CONTACT US FOR FURTHER DETAILS. Andy Pham

Managing Member Email: andy@BiosafeDefenses.com Phone: (800) 488-2909