Lakewood-Amedex Biotherapeutics Inc. · NASDAQ:LABT
Lakewood-Amedex Biotherapeutics — Lakewood-Amedex — Investor Presentation (September 2014)
31 slides from Lakewood-Amedex Biotherapeutics's investor presentation, September 2014
Slide 1: Corporate Overview and Strategy
Corporate Overview and Strategy September 2014 Lakewood-Amedex is a privately-held development-stage biopharmaceutical company that has an innovative portfolio of novel, broad-spectrum antimicrobials, antivirals, and targeted therapeutics.
Slide 2: About Lakewood-Amedex, Inc.
About Lakewood-Amedex, Inc. Revolutionary development-stage biopharmaceutical company founded in 2006 and based in Sarasota, Florida Primary Focus: Novel Bisphosphocin™ Antimicrobial Platform Disruptive technology that was discovered accidently while exploring the use of nRNA ‘Gene Silencing’ to com
Slide 3: The SuperBug Threat
The SuperBug Threat Antimicrobial resistance is recognized as one of the greatest threats to human health worldwide… The annual cost to the U.S. healthcare system of resistant infections is $21–34 billion. Source: Infectious Disease Society of America (IDSA), April 2011, "Combating Antimicrobial Res
Slide 4: The Importance of Antibiotics
The Importance of Antibiotics Significant Longevity Driver The discovery of antibiotics in 1928 was one of most significant factors driving the dramatic rise of average life expectancy in the 20th century, singlehandedly increasing longevity by an estimated ten years Nevertheless, infections remain
Slide 5: How Antibiotics Work
LAKEWOOD AmepeX ow Antibiotics Work Fungus Antibiotic Bacteria Bacteria divides and cell wall disintegrates Resistance é & Fungus Antibiotic Bacteria attacks antibiotic Bacteria pumps antibiotic out of t Wee AmEDEX
Slide 6: Resistance Poses Increasing Threat
Resistance Poses Increasing Threat Each year in the United States, at least two million people acquire serious infections with bacteria that are resistant to one or more of the antibiotics designed to treat those infections. At least 23,000 people die each year as a direct result of these antibiotic
Slide 7: About Bisphosphocins
About Bisphosphocins™ Novel broad-spectrum antimicrobial class Directly bactericidal mechanism of action that overcomes development of antibiotic resistance Treats all known bacterial infections; effective against all 70 strains of bacteria tested thus far All of the “Most Wanted” ESKAPE strains (70
Slide 8: Antibiotics vs. Bisphosphocins
Antibiotics vs. Bisphosphocins™ Conventional Antibiotics / Antifungals Our Bisphosphocin™ Technology Mechanism of • Inhibits Growth of Pathogens, Relying on the • Directly Kills Harmful Pathogens by Disrupting Their Cell Membranes Action Immune System to Kill Bacteria • Significant Safety Issues • A
Slide 9: Effective Against 70+ Pathogens
Effective Against 70+ Pathogens ESKAPE Pathogens Other Key Pathogens Enterococcus faecium (g+) NDM-1 strains Staphylococcus aureus (g+) 10-minute time kills of 11 strains 1 Klebsiella species (g-) Biofilm-producing strains Acetobacter baumannii (g-) S. aureus (<10-min, except one strain) Pseudomonas
Slide 10: Our Novel Mechanism of Action
Our Novel Mechanism of Action Bisphosphocins™ are Bacterial (prokaryotic) cell walls Bisphosphocins™ bind to the administered intravenously, differ depending on the cell membrane, disrupting it orally, or topically. organism, but their membranes and causing depolarization are identical. and apoptosi
Slide 11: Validation of our Novel Mechanism
Validation of our Novel Mechanism S. aureus was exposed to Bisphosphocin™ Nu-3 for 2.5 hours The effect on membrane potential was then visualized using the BacLight ™ flourescent dye followed by FACS analysis 10
Slide 12: Time-Kill: Nu-3 vs. Vancomycin
Time-Kill: Nu-3 vs. Vancomycin 11
Slide 13: Nu-3 Concentration and Time Effect
Nu-3 Concentration and Time Effect Acetobacter baumannii Klebsiella pneumoniae Reduction in CFU Nu-3 Concentration After 5 min After 15 min After 5 min After 15 min 10 mg/ml >5 log >5 log 5 mg/ml >5 log >5 log 1 mg/ml 1 log 5 log 3-4 log 5 log 12
Slide 14: Effective Against Biofilm Strains
Effective Against Biofilm Strains Presented at 2013 ICAAC Conference Conducted by Tufts University Six virulent biofilm-producing strains were grown on glass tubes and then treated with Nu-3 for 10 and 30 minutes 100% bacterial kill achieved in 10 minutes or less1 1 One strain of Staphylococcus requ
Slide 15: Effect of Nu-2 and Nu-3 on Bacterial Growth and Biofilm Formation
Effect of Nu-2 and Nu-3 on Bacterial Growth and Biofilm Formation Nu-2 Nu-3 14
Slide 16: No Evolved Resistance Against Nu-2
No Evolved Resistance Against Nu-2 0.12 Control Ampicillin 0.10 Nu-2 Growth A625nM 0.08 0.06 0.04 Having extended this study out to 30 days, with 0.02 no indication of resistance, we believe 0.00 these data supports the -0.02 premise that bacteria are incapable of evolving 0 1 2 3 resistance against
Slide 17: Nu-2 Serial Passage Resistance Study
Nu-2 Serial Passage Resistance Study Nu-2 Nu-2 Control 1.56mg/ml 0.39mg/ml Day 0 1-2 x 105 CFU Day 12 1-2 x 105 CFU Day 22 2-4 x 105 CFU 16
Slide 18: Chronic Lung Infections in Mice
Chronic Lung Infections in Mice % of Mice with Residual Pseudomonas aeruginosa Lung Infection 1 Week After a Single Aerosol Treatment with Liposomal Nu-3 100% 90% 90% of treated mice had 80% no infection after a 70% single treatment with Nu-3 60% 50% By comparison, 40% conventional antibiotics 30% w
Slide 19: Burn Wound Infections in Mice
Burn Wound Infections in Mice P. aeruginosa (Utah 4) Burn Wound Infection Model (subcutaneous delivery) P. aeruginosa (Utah 4) Burn Wound Infection Model (topical delivery) Reproduced from “Therapeutic Efficacy of “Nubiotics” against Burn Wound Infection by Pseudomonas aeruginosa” Antimicrobial Agen
Slide 20: Safe and Non-Toxic in Mice
Safe and Non-Toxic in Mice Nu-3 (IV, Oral and Topical) Dosing Groups for Nu-3 study Sprague Dawley Rat Toxicology IV Doses: 50, 100, 200mg/kg LD50 ≥ 1,000 mg/kg Oral Doses – 100, 250mg/kg LD50 ≥ 2,001 mg/kg Full CBC, metabolic panel, and pK analysis conducted, with no observed differences between co
Slide 21: Individual Human Case Studies
Individual Human Case Studies 90+ human case studies have been completed. All study patients showed either complete recovery or improvement in infection severity. Examples: 75-yr-old Male with diabetic foot ulcers; 14-day treatment with 1% Bisphosphocin™ drops reduced the ulcers from approximately 1
Slide 22: Development Pipeline
evelopment Pipeline Bisphosphocins™ Preclinical Phase | Phase Il Phase Ill Nu-3 (topical) Ph. I/Ila to start 4Q14 z complicated Diabetic Foot Ulcers (cDFU) Nu-3 (systemic) [_2 Priority] Ph. | to start 1H15 complicated Urinary Tract Infections (cUTI) nRNA ‘Gene Silencing’ Programs Preclinical Phase I
Slide 23: Nu-3 Topical Ph I/IIa Trial
Nu-3 Topical Ph I/IIa Trial Phase I/IIa Trial Design About cDFU 1st Pre-IND meeting in 4Q13 Common and Serious Complication 2nd Pre-IND meeting in 3Q14 of Diabetes Mellitus Occurs in 20% of patients Open-label trial of 30 volunteers Significantly impacts QoL with complicated diabetic foot ulcers Mos
Slide 24: Nu-3 Systemic Ph Ia Trial
Nu-3 Systemic Ph Ia Trial Phase Ia Trial Design About cUTI Pre-IND meeting in 1H15 Complicated UTI An infection of the upper urinary tract in male, Double-blind, placebo-controlled immunocompromised, or pregnant patients with (or open-label) trial of 64 healthy diabetes mellitus Often results from c
Slide 25: Comparables
Comparables Cubist’s Cubicin™ (daptomycin) Reserved for gram-positive systemic infections Administered only in hospitals via IV Sales of more than $900 million per year Abbreviations: 1 C. difficile-associated diarrhea 2 Complicated Skin and Skin Structure Infections 3 Complicated Urinary Tract Infe
Slide 26: Market Opportunity ($50B+)
Market Opportunity ($50B+) Topical Infections Systemic Infections Dermatology (Skin) Bacterial Infections Complicated Skin and Skin Structure Complicated Urinary Tract Infections (cUTI) Infections (cSSSI) Ventilator-Associated Pneumonia Acne Vulgaris Otitis Externa Fungal Infections Systemic Candidi
Slide 27: Senior Management
Senior Management More than 30 years of More than 25 years of product biopharmaceutical leadership development experience experience, including 14 as CEO Co-Founder and VP of Product Co-Founder and CEO of Development of TranXenoGen TranXenoGen, which achieved a peak valuation of $230M on the Leaders
Slide 28: Scientific Advisory Board
Scientific Advisory Board Dr. Bruce Forrest, MD, MBA Dr. Jonathan Wong Former Global Head Vaccines and Research Defense Scientist, Infectious Diseases, Wyeth Defense R&D Canada Pharmaceuticals Dr. Ted Brown, Jr, MD Dr. John Sinnott, MD Board-Certified Ear, Nose and Assoc. Dean USF Throat Surgeon Dir
Slide 29: Robust Intellectual Property
Robust Intellectual Property Portfolio of 70+ Patents Composition-of-Matter and “XYZ” Patents Method of Use Patents Manufacturing Process Patents Patent Protection Through At Least 2027 Including GAIN Act, Hatch-Waxman, and Orphan Drug designations Potential to further extend coverage with formulati
Slide 30: Antibiotics Landscape
Abbreviations: 1 C. difficile-associated diarrhea 2 Complicated Skin and Skin Structure Infections Antibiotics Landscape 3 Complicated Urinary Tract Infections 4 Complicated Intra-Abdominal Infections 5 Community-Acquired Bacterial Pneumonia 6 Acute Bacterial Skin and Skin Structure Infections 7 Car
Slide 31: RNAi Landscape
RNAi Landscape Market Annualized Development Company Ticker Product(s) Description Indication(s) Capitalization ($M) Sales ($M) Stage NASDAQ: KYNAMRO homozygous familial 4,570 147 Approved apo-B synthesis inhibitor ISIS (mipomersen) hypercholesterolemia NASDAQ: transthyretin-mediated 5,490 47 ALN-TT
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