COMPANY INTRODUCTION 2019 - BIOSAFEDEFENSES.COM - BIOSAFE DEFENSES
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COMPANY INTRODUCTION
2019
BiosafeDefenses.com
Andy Pham Biosafe Defenses, LLC
Managing Member Cecci VentureLab
Email: andy@BiosafeDefenses.com Lobo Rainforest Building
Phone: (800) 488-2909 101 Broadway Blvd. NE, Suite 1100
Albuquerque, NM 87102
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 2
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 • Bandages • Paints
• Medical Devices • Bedding/Linens • Plastics
• Medical Implants • Gloves/Masks • Polishes
• Hospitals • Lab Coats • Sealants
• Schools • Surgical Gowns • Soaps
• Public Facilities • Gauze • Detergents
• Household Surfaces • Towels • Disinfectant Sprays
• Doorknobs/Buttons • Wipes • Dental Products
• Surgical Instruments • Air/Water Filtration • Anti-Fungal
• Medical Disposables • Household Products • Dental Products
Advantages & Benefits
• Broad-spectrum activity against fungi, • Effectively kills drug-resistant pathogens
bacteria, and viruses
• Two-pronged attack lessens likelihood of
• Keeps surfaces clean for at least 24 hours eliciting antimicrobial resistance
• Recommended sanitizer for non-food contact • Environmentally friendly degradation
surfaces
pathway
• Provides an effective method for killing
microbes • Compatible with detergents and
surfactants
• Inhibits biofilm growth
• Non-irritating to skin
• Eradicates biofilms with antibiotic-grade
efficacy • Non-toxic to endothelial and epithelial
cells
• May be incorporated onto textiles and hard,
non-porous surfaces: metals, plastics, and • Visual fluorescent tracking allows end-
glass users to know when reapplication is
necessary
• Functional in self-sanitizing, self-cleaning
surfaces
3
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.
4
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…”
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].”
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.
5
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.
Untreated
E. coli
E. coli Treated
with Biosafe
CPE
E. coli Treated
with Biosafe
CPE
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.
6
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 Time to Reapply!
• Real-time fluorescence indication
(to discern clean areas from
contaminated or uncleaned areas).
• No irritant to skin
• No odor
7Initial 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. 8
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 Co-inventor; Editor-In-Chief of
ACS Applied Materials & AMI. Published research has
Interfaces (AMI); Associate received 500+ citations every
Director of UNM’s Center for year since 2005.
Biomedical Engineering.
“ 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.
25 years’ experience in the venture
capital industry. Manages over
Andy Pham
$200M in funds, including pre-
Managing Member
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.
9Appendix
Medical Concerns Related to Commonly Used Antiseptics 11
Biosafe's Antimicrobials 12
Changing an Industry 16
10Medical 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.
11Biosafe’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… 12
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.
Self-Sanitizing Activity of Dried Chemical Residues on
100% Polypropylene
Biosafe PPE Clorox Bleach
Bacterial Survivability
75%
50%
25%
0%
0 4 8 13 17 21
Time Elapsed following Application of Disinfectant [hours]
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.
134) 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.
146) 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. 15
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
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