Hoth Therapeutics, Inc. · NASDAQ:HOTH
Hoth Therapeutics — Investor Presentation (October 2019)
33 slides from Hoth Therapeutics's investor presentation, October 2019
Slide 1: Corporate Presentation
Corporate Presentation (NASDAQ: HOTH) Fall 2019
Slide 2: Disclaimer and Safe Harbor
Disclaimer and Safe Harbor Safe Harbor Statement This presentation contains "forward-looking statements" within the meaning of the “safe-harbor” provisions of the Private Securities Litigation Reform Act of 1995. These statements are identified by the use of words “could”, “believe”, “anticipate”, “
Slide 3: Our Mission
Our Mission Biopharmaceutical company focused on unique therapeutics for patients suffering from indications such as atopic dermatitis, also known as eczema, as well as dermatological and chronic wound disorders, psoriasis and acne. 3
Slide 4: Key Partnerships
Key Partnerships Ole Cincinnati = Py University of Children’s (CE CINCINNATI Hospital Medical Center MASSACHUSETTS GENERAL HOSPITAL ~ Zyl6o (I| UNIVERSITY yo MUL ¢/ MARYLAND “ BALTIMORE THE GLOBAL 505(B)(2) EXPERTS Camargo "PARTICLE SCIENCES PHARMACEUTICAL SERVICES @ HOTHTHERAPEUTICS 4
Slide 5: Company Overview
Company Overview • The BioLexa Platform Financial Highlights: • A proprietary, patented, drug compound platform Symbol: NASDAQ: • Developed at the University of Cincinnati HOTH • Achieved positive results at preclinical Share Price $3.92 studies conducted at the University of Miami (as of 10/18/19):
Slide 6: Defined Pathway for Value Creation
Defined Pathway for Value Creation • Large total addressable market with broad consumer appeal • Proprietary BioLexa Platform technology which combines two existing approved drugs enabling reliance on existing safety data for those drugs • VNLG 152 – strong pre-clinical data in cancer and dermatolog
Slide 7: Developing Pipeline
Developing Pipeline Product Candidate Indication Stage of Development CLINICAL STAGE DEVELOPMENT PROGRAMS PRECLINICAL PHASE 1 PHASE 2 PHASE 3 BIOLEXA PLATFORM A patented topical non-corticosteroid approach, Proposed Atopic Dermatitis inhibiting the formation of biofilms BIOLEXA PLATFORM A patented a
Slide 8: Dermatology Offers Attractive Returns and Exits
Dermatology Offers Attractive Returns and Exits Atopic dermatitis market predicted to grow $7.2B in 2017 to $24B by end of 2027* Pfizer acquired Anacor for $4.9B on June 24, 2016 Over 60% premium over Anacor stock price prior to announcement Anacor’s lead product, Eucrisa, is a topical treatment
Slide 9: BioLexa Technology Overview
BioLexa Technology Overview BioLexa is a combination of gentamicin antibiotic and the zinc ion binder DTPA Proprietary platform technology combines two existing approved drugs enabling reliance on existing safety data for those drugs reducing expected time to market from 10-12 years to 4-6 years
Slide 10: BioLexa Platform for Atopic Dermatitis
BioLexa Platform for Atopic Dermatitis Atopic Dermatitis is a large and growing market - Affects more than 32 million patients in the US - 10-20% of all pediatric patients suffer from Atopic Dermatitis - Need for new, differentiated therapies The BioLexa Platform offers a non corticosteroid approach
Slide 11: A Different Approach to Atopic Dermatitis
A Different Approach to Atopic Dermatitis Current Treatments Unmet Medical Needs BioLexa’s Approach Topical Steroids Current treatments are Topical, localized delivery expensive OTC moisturizers Systemic delivery which Intended to delay and prevent safety risks symptoms Oatmeal baths Undesirable sid
Slide 12: Biofilms Inhibit the Treatment of Atopic Dermatitis
Biofilms Inhibit the Treatment of Atopic Dermatitis • Staph aureus makes up 20% of the bacteria on skin and 40% on lesions • Exposure to water or salt and slight perspiration prompts biofilm formation and clogs the sweat ducts which triggers an immune response • Immune response combined with gene de
Slide 13: BioLexa Inhibits the Formation of Biofilms
BioLexa Inhibits the Formation of Biofilms Source: Image Biofilms in Infections, Dr. TV RAO, MD https://slideshare.net/doctorrao/biofilms-2172226 13
Slide 14: BioLexa Eczema Phase 2 Clinical Trial
BioLexa Eczema Phase 2 Clinical Trial Phase 2b – Safety Double-blind, placebo controlled study to evaluate the safety and efficacy of topical Design Trial; Parallel assignment; Quadruple masking: participant, care provider, investigator, outcomes assessor. Enrollment patients with mild-moderate atop
Slide 15: BioLexa Minipig Study: Results
BioLexa Minipig Study: Results This study concluded that the formula of the BioLexa Platform is the most effective treatment to reduce bacteria growth and inhibit the formation of biofilms. Either Alone Not Adequate Combination Works Best Combination reduced DTPA Gentamicin bacteria below LOQ alone
Slide 16: BioLexa Platform for DFU & Chronic Wound Disorders
BioLexa Platform for DFU & Chronic Wound Disorders Diabetic Foot Ulcers affect approximately 9.1-26.1M people worldwide, diabetes are likely to be affected.* - Unmet need for therapeutic approaches that heal wounds with S. aureus The BioLexa Platform can help by - Accelerating the healing of diabeti
Slide 17: BioLexa Platform: Chronic Wounds Disorders
BioLexa Platform: Chronic Wounds Disorders • Exclusive license to technology for optimizing healing of diabetic skin lesions. • Hoth has executed an agreement with Massachusetts General Hospital to conduct a pilot study on the efficacy of BioLexa to: • Accelerate acute diabetic wound healing; • Init
Slide 18: BioLexa Platform: Market Opportunity
BioLexa Platform: Market Opportunity US Market Opportunity Indication Medical Need Target Patients (USD) Eczema and Atopic Dermatitis Mild to Moderate 32M1 $9.5B1 Aesthetic Improve healing, Dermatology cosmetic outcomes 8.8M2 $1.9B2 Chronic Diabetic Accelerate and Ulcers healing 10M³ $2.8B³ Source 1
Slide 19: VNLG 152: Acne & Psoriasis
VNLG 152: Acne & Psoriasis Nearly 7.5 million people are affected by psoriasis in the US alone and represent about approximately 100,000 new cases reported each year.* 60 million people suffering from all grades of acne in the US, 20% of which is severe scarring.** VNLG 152: Lead retinamide RAMBAs d
Slide 20: VNLG 152 – Psoriasis & Acne
VNLG 152 – Psoriasis & Acne Dermatology Applications: • Licensed from the University of Maryland, Baltimore • Provides a unique approach to achieve the therapeutic benefit of retinoid therapy while potentially circumventing the adverse events associated with it, a very important property for applica
Slide 21: VNLG 152 – Psoriasis & Acne
VNLG 152 – Psoriasis & Acne Acne Market • Acne: More than 90% of the world's population is found to be affected by acne at some point in their life. In the United States, there are 60 million suffering from acne problems. This includes all grades of acne, from the mild, occasional breakout to more s
Slide 22: Z-pods to Treat Cutaneous Lupus Erythematosus (CLE)
Z-pods™ to Treat Cutaneous Lupus Erythematosus (CLE) Approximately 1.5 million Americans currently suffer from lupus and of two thirds will develop CLE* • Lupus is most likely to effect women • Lupus is 2-3 times more likely to effect women of color Advantages over the standard of care: • Improves d
Slide 23: Z-pods to Treat Cutaneous Lupus Erythematosus (CLE)
Z-pods™ to Treat Cutaneous Lupus Erythematosus (CLE) • Hoth has a partnership agreement with Zylö Therapeutics to develop Anandamide-loaded Z-pods™ for the treatment of CLE in North America. • Patent protected technology for a topical delivery system using xerogel- derived nanoparticles called Z-pod
Slide 24: Aprepitant to Treat Side Effects of Erlotonib
Aprepitant to Treat Side Effects of Erlotonib Erlotinib is a drug that is used to combat various cancers and has been degrees of skin rashes, lesions, hair loss and nail changes to patients* Sponsored Research Agreement with the George Washington University to of Aprepitant for topical and/or system
Slide 25: Genetic Marker for Food Allergies & Eczema
Genetic Marker for Food Allergies & Eczema In the U.S., food allergies affect about 2% of adults and 4% to 8% of children Annual estimate in U.S. of health events from food allergies - 30,000 hospitalizations; 150 deaths Advantages over the standard of care: • Eliminates need for potentially dangero
Slide 26: Genetic Marker for Food Allergies & Eczema
Genetic Marker for Food Allergies & Eczema • Hoth has an exclusive license from the University of Cincinnati • Patent protected technology for determining a person’s propensity to develop an allergic reaction to certain types of food, including: • Peanut allergy; • Milk allergy; • General food aller
Slide 27: Genetic Marker for Food Allergies & Eczema
Genetic Marker for Food Allergies & Eczema • Dr. Gurjit Khurana Hershey’s study performed in association with University of Cincinnati and Cincinnati Children’s Hospital Medical Center sought to identify genetic markers that would predict common food allergies and propensity to develop eczema. • Ana
Slide 28: Investment Highlights
Investment Highlights Unique small cap Multi-billion market Proprietary platform Experienced pharma investment opportunity with technology which team, board of opportunity with unmet need for both two existing and scientific shots on goal and Company’s primary drugs enabling proven drug business mod
Slide 29: Scientific Advisors
Scientific Advisors Name & Title Background Jonathan Hale Zippin M.D., Ph.D. is an Associate Professor of Dermatology and Pharmacology Dermatologist at Weill Medical College of Cornell University. Dr. Zippin is the current Vice Department of Dermatology and is the Director of the Contact, Occupation
Slide 30: Scientific Advisors
Scientific Advisors Name & Title Background Adam Friedman, MD, FAAD is a Professor of Dermatology and serves as Residency Program Director, and Director of the Supportive Oncodermatology Program in the Department of Dermatology at The Medicine & Health Sciences. Dr. Friedman is currently investigati
Slide 31: Scientific Advisors
Scientific Advisors Name & Title Background Dr. Gurjit Khurana Hershey is the Director of the Division of Asthma Research, and is an endowed Children's Hospital and the University of Cincinnati College of Medicine. She received her medical and University School of Medicine in St. Louis, Missouri and
Slide 32: Management Team
Management Team Name & Title Background President of Lifleline Industries Inc, since 1995 20+ years of equity markets experience, semiconductor and telecommunications ROBB KNIE Board positions with NASDAQ listed companies and management positions with President, CEO and Director Advisors CFO
Slide 33: Intellectual Property and License Terms Summary
Intellectual Property and License Terms Summary Country Patent Expiration Issue Date Issued Pending EU Patent covering compositions and 2028 October 2014 Issued claims focused on a composition that inhibits bacterial US & PCT 2034 November 2017 and biofilms, often found in skin as atopic dermati
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