Hoth Therapeutics, Inc. · NASDAQ:HOTH
Hoth Therapeutics — Investor Presentation (April 2022)
46 slides from Hoth Therapeutics's investor presentation, April 2022
Slide 1: Clinical-Stage Biopharmaceutical Company Focused on Next Generation Therapeutics
www.hoththerapeutics.com NASDAQ: HOTH Clinical-Stage Biopharmaceutical Company Focused on Next Generation Therapeutics Meeting Unmet Patient Needs APRIL 2022 1
Slide 2: Safe Harbor Statement
www.hoththerapeutics.com NASDAQ: HOTH Safe 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,” “intend
Slide 3: Our Mission
www.hoththerapeutics.com NASDAQ: HOTH Hoth Therapeutics is a biopharmaceutical visionary dedicated to finding, investigating and developing early-stage therapeutics that will change the way diseases are managed and treated. Hoth Therapeutics seeks to develop drugs that improve treatments and address
Slide 4: Key Investment Highlights
www.hoththerapeutics.com NASDAQ: HOTH Key Investment Highlights Clinical Programs Robust Pre-Clinical Targeting Unmet Medical Experienced Management Development Programs Needs to Address Broad and Advisory Board Market 4
Slide 5: Pipeline: Multiple Shots on Goal
www.hoththerapeutics.com NASDAQ: HOTH Pipeline: Multiple Shots on Goal 5
Slide 6: Primary Development Pipeline
www.hoththerapeutics.com NASDAQ: HOTH HT-001 Phase 2a Clinical Trial in Humans Targeted for Q1 2023 HT-KIT Orphan Drug Designation/ Pre-IND submission Targeted for Q4 2022 PRIMARY HT-ALZ DEVELOPMENT Alzheimer’s Disease HT-TBI **NEW Traumatic Brain Injury/ Stroke BioLexa Lotion Phase 1b Clinical Tria
Slide 7: HT-001: Value Proposition
www.hoththerapeutics.com NASDAQ: HOTH HT-001 : Value Proposition Market Growth: EGFR Inhibitor Skin Toxicity market predicted to grow from $52M in 2018 to $391M by end of 2030* Mechanism of Action: 12-week study conducted at GW suggests the topical application of HT-001 significantly reduces erlotin
Slide 8: Recent Milestones: HT-001
www.hoththerapeutics.com NASDAQ: HOTH Recent Milestones: HT-001 8
Slide 9: CLEER-001 Phase 2a Dose Ranging Study
www.hoththerapeutics.com NASDAQ: HOTH IND-Opening Trial: CLEER-001 Phase 2a Dose Ranging Study • A Randomized, Placebo-Controlled, Parallel Phase 2a Dose Ranging Study to Investigate the Efficacy, Safety, and Tolerability of Topical HT-001 for the Treatment of Cutaneous Toxicities Associated with EG
Slide 10: Proposed HT-001 Phase 2a Design: Part 1
www.hoththerapeutics.com NASDAQ: HOTH Proposed A Randomized, Placebo-Controlled, Parallel Phase 2a Dose Ranging Study to HT-001 Phase Investigate the Efficacy, Safety, and Tolerability of Topical HT-001 for the 2a Clinical Trial Treatment of Skin Toxicities Associated with EGFR Inhibitors Design Par
Slide 11: Proposed HT-001 Phase 2a Design: Part 2
www.hoththerapeutics.com NASDAQ: HOTH Proposed A Randomized, Placebo-Controlled, Parallel Phase 2a Dose Ranging Study to HT-001 Phase Investigate the Efficacy, Safety, and Tolerability of Topical HT-001 for the 2a Clinical Trial Treatment of Skin Toxicities Associated with EGFR Inhibitors Design Par
Slide 12: Proactive Topical HT-001 Reduces EGFR Inhibitor-Induced Cutaneous Toxicity
www.hoththerapeutics.com NASDAQ: HOTH Proactive Topical HT-001 Significantly Reduces EGFR Inhibitor-Induced Cutaneous Toxicity Group Change Compared to Change Compared to Erlotinib Only Group: Erlotinib Only Group: HT-001 Facial Skin Lesions at 12 Hair Loss at 12 weeks weeks Preventative 58.5% Reduc
Slide 13: HT-KIT: Value Proposition
www.hoththerapeutics.com NASDAQ: HOTH HT-KIT : Value Proposition Market Growth: Global systemic mastocytosis treatment revenue is $128M and projected to grow at 5.8% CAGR through 2031* Mechanism of Action: HT-KIT is an antisense oligonucleotide that results in non-functional cKIT via mRNA frameshift
Slide 14: Recent Milestones: HT-KIT
www.hoththerapeutics.com NASDAQ: HOTH Recent Milestones: HT-KIT 14
Slide 15: HT-KIT inhibits tumor growth in xenograft model
www.hoththerapeutics.com NASDAQ: HOTH Systemic delivery of human HT-KIT inhibits tumor growth in a humanized xenograft mast cell neoplasia model HT-KIT HT-KIT Figure from Snider 2021 15
Slide 16: HT-KIT reduces liver infiltration of mast cells
www.hoththerapeutics.com NASDAQ: HOTH HT-KIT reduces liver infiltration of neoplastic mast cells in a humanized xenograft model of mast cell neoplasia HT-KIT HT-KIT HT-KIT HT-KIT Figure from Snider 2021 16
Slide 17: HT-ALZ: Value Proposition
www.hoththerapeutics.com NASDAQ: HOTH HT-ALZ: Value Proposition Market Growth: The Global Alzheimer’s Disease Treatment Market is expected to grow at a CAGR of around 12.8% from 2020 to 2027 and reach the market value of over $5.2B by 2027.* Mechanism of Action: HT-ALZ targets Substance P** in the b
Slide 18: Recent Milestones: HT-ALZ
www.hoththerapeutics.com NASDAQ: HOTH Recent Milestones: HT-ALZ 18
Slide 19: HT-ALZ Abstract Accepted at AAIC 2022
www.hoththerapeutics.com HT-ALZ Abstract Accepted at AAIC NASDAQ: HOTH 2022 July 31 – August 4 in San Diego, CA 19
Slide 20: HT-TBI: Value Proposition
www.hoththerapeutics.com NASDAQ: HOTH HT-TBI: Value Proposition Market Growth: The global stroke management market size was valued at $31.7B in 2020, and is projected to reach $67.7B by 2030, registering a CAGR of 7.8% from 2021 to 2030.* The traumatic brain injuries treatment market to account $201
Slide 21: Upcoming Milestones: HT-TBI
www.hoththerapeutics.com NASDAQ: HOTH • Submit BARDA Grant paperwork Upcoming Milestones: HT-TBI 21
Slide 22: BioLexa Lotion: Value Proposition
www.hoththerapeutics.com NASDAQ: HOTH BioLexa Lotion : Value Proposition Market Growth: Atopic dermatitis market predicted to grow from $6.4B in 2017 to $18.3B by end of 2027* Mechanism of Action: Novel mixture of two previously approved compounds targeting the underlying Staphylococcus aureus infec
Slide 23: Recent Milestones: BioLexa Lotion
www.hoththerapeutics.com NASDAQ: HOTH • The interim safety review of Cohort 1 healthy subjects indicates that BioLexa was well tolerated with no serious adverse events and no drug-related treatment-emergent adverse events Recent observed. Milestones: • Cohort 2 with patients with mild to moderate at
Slide 24: BioLexa Phase 1b Clinical Study Design
www.hoththerapeutics.com NASDAQ: HOTH A Randomised, Double-Blind, Vehicle Controlled, Sequential Group Study to Determine the Safety, Tolerability, Pharmacokinetics and Efficacy of Twice Daily Application of Topical BioLexa™ in Adult Healthy Subjects and Patients with Mild to Moderate Atopic Dermati
Slide 25: BioLexa: Proof-of-Concept Results
www.hoththerapeutics.com NASDAQ: HOTH BioLexa: Proof-of-Concept Results This study concluded that the combination of gentamicin and Ca-DTPA is more effective to reduce bacteria growth and inhibit the formation of biofilms than each compound individually. Either Alone Not Adequate Combination Works B
Slide 26: Recent Milestones & Upcoming Catalysts: Primary Development
www.hoththerapeutics.com NASDAQ: HOTH Recent Milestones & Upcoming Catalysts: Primary Development Q4 2021 Q1 2022 Q2 2022 Q3 2022 Q4 2022 HT-001 Clinical Protocol Clinical Site Selection Initiate GMP GMP Manufacturing US IND submission (Cutaneous toxicity of Development GLP Tox Studies Manufacturing
Slide 27: Preclinical Development: HT-003 and HT-004
www.hoththerapeutics.com NASDAQ: HOTH HT-003 PRECLINICAL Acne, Inflammatory Bowel Diseases DEVELOPMENT HT-004 Asthma, Allergic Inflammation 27
Slide 28: HT-003: Value Proposition
www.hoththerapeutics.com NASDAQ: HOTH HT-003: Value Proposition Market Growth: The global acne treatment market size was valued at $5.46 Bn in 2019 & is projected to reach $7.19 Bn by 2027, with a CAGR of 4.6% during forecast period.* IBD Treatment market was valued at USD 15.87 billion by 2019, gro
Slide 29: Recent Milestones: HT-003
www.hoththerapeutics.com NASDAQ: HOTH • Dermatology preclinical studies with 3 molecules completed for acne in Q1 2022 Recent • IBD initial preclinical ex vivo studies 4 Milestones: molecules completed in Q1 2022 HT-003 • Pharmacology: metabolite profiling and single dose pharmacokinetic studies com
Slide 30: HT-003-D: Dermal Preclinical Study Results
www.hoththerapeutics.com NASDAQ: HOTH HT-003-D : Dermal Preclinical Study Results TLR2 is one of the most critical genes for acne pathophysiology Data shows that HT-003 significantly downregulates TLR2 expression after challenge with PGN (TLR2 agonist) in an in vitro human keratinocyte model 30
Slide 31: HT-003-IBD: Preclinical Study Results
www.hoththerapeutics.com U U IL-17alpha release ns ns IL-22 release (% Control) tim tim (% Control) ul ul at at e 100 150 0 50 d ed 100 150 200 250 0 50 co co nt nt r ro l ol Ve Ve h i hi cl cl e e B B IR IR B B C 7 C 79 F FW 96 6 W 0 00 0 C 1 1 C /0 FW /01 F 1 W 00 0 1 0 C 1 C /0 FW /02 F 2 W 00 0
Slide 32: HT-003-IBD: Crohn's Ex Vivo Results
www.hoththerapeutics.com NASDAQ: HOTH HT-003-IBD: Preclinical Study Results Crohn’s Ex Vivo Tissue (n = 1 donor) 150 150 150 HT-003 molecules IL-17alpha release IL-22 release (% Control) IL-10 release (% Control) (% Control) 100 100 100 reduce inflammatory 50 50 50 cytokines 0 associated with 0 0 tr
Slide 33: HT-004: Value Proposition
www.hoththerapeutics.com NASDAQ: HOTH HT-004: Value Proposition Market Growth: The global asthma therapeutics market reached a value of $17.6B in 2020. The market is expected to reach a value of $19.13B by 2026, expanding at a CAGR of 1.60% during 2021-2026.* Mechanism of Action: Target IgE receptor
Slide 34: Recent Milestones: HT-004
www.hoththerapeutics.com NASDAQ: HOTH • Development of humanized mouse model for HT-004 target completion Recent Q2 2022 Milestones: • Testing in the humanized mouse model with HT-004 will be initiated HT-004 pending completion of the model 34
Slide 35: HT-004: Asthma & Allergic Inflammation
www.hoththerapeutics.com NASDAQ: HOTH HT-004: Asthma & Allergic Inflammation • Peribronchiolar Inflammation was reduced by inhalation of HT-004 that n.s. targets FcER1-beta alternative exon splicing. **** • Ovalbumin inhalation induced airway-centric recruitment of Bronchiolar inflammation score 5 *
Slide 36: Recent Milestones and Upcoming Catalysts: Pre-Clinical
www.hoththerapeutics.com NASDAQ: HOTH Recent Milestones and Upcoming Catalysts: Pre-Clinical Q4 2021 Q1 2022 Q2 2022 Q3 2022 Q4 2022 HT-003D Mouse model studies Pharmacology studies (Acne) HT-003IB Ex Vivo tissue studies with Pharmacology studies Intellectual Property (IBD) additional donors HT-004
Slide 37: Breath Detect Diagnostic Device
www.hoththerapeutics.com NASDAQ: HOTH Sensor on Chip Breath Detect Diagnostic Device Breath Collection Tube 37
Slide 38: Direct Detect Breath Diagnostic Device System
www.hoththerapeutics.com NASDAQ: HOTH Direct Detect Breath Diagnostic Device System • Novel diagnostic platform technology that uses nanohole array (NHA) based plasmonic sensors for detection of a wide range of target analytes in breath • Infectious Diseases: Detection of target viruses, bacterial o
Slide 39: Market overview
Market overview Point of Care & Rapid Diagnostics Market by Product (Glucose, Infectious Disease(HIV, Hepatitis C), Pregnancy Test), Platform (Microfluidics, Dipsticks), Mode of Purchase (OTC, Prescription), End User (Pharmacy, Hospital, Home) - Global Forecast to 2027. Markets and Markets. 39
Slide 40: Investment Highlights
www.hoththerapeutics.com NASDAQ: HOTH Investment Highlights Two Programs in Clinical ✓ Addressing multi-billion dollar unmet market opportunities across indications Stage of Development ✓ BioLexa Lotion - Novel mixture of two FDA-approved compounds – in clinical phase of development ✓ HT-001 – no ap
Slide 41: Appendix
www.hoththerapeutics.com Appendix NASDAQ: HOTH 41
Slide 42: Management Team
www.hoththerapeutics.com NASDAQ: HOTH Management Team Robb Knie Stefanie Johns, Ph.D. David Briones Jonathan Zippin, M.D., Ph.D. Chief Executive Officer Chief Scientific Officer Chief Financial Officer Senior Scientific Advisor Hoth Therapeutics, Inc. Associate Attending Dermatologist Vice Chair of
Slide 43: Board of Directors
www.hoththerapeutics.com NASDAQ: HOTH Board of Directors Wayne Linsley Graig Springer, J.D. Director Director Hoth Therapeutics, Inc. Hoth Therapeutics, Inc. President Vice President Flagship Group, Inc. Legal & Regulatory Brookfield Asset Management David Sarnoff, Esq. Director Hoth Therapeutics, I
Slide 44: Scientific Advisory Board
www.hoththerapeutics.com NASDAQ: HOTH Scientific Advisory Board Carla Yuede, Ph.D. Adam Friedman, M.D. Mario Lacouture, M.D. Associate Professor of F.A.A.D. Attending Physician Psychology Professor & Chair of Director of Oncodermatology Director of Animal Dermatology Memorial Sloan Kettering Behavio
Slide 45: Scientific Advisory Board
www.hoththerapeutics.com NASDAQ: HOTH Scientific Advisory Board Vincent Njar, Ph.D. John Cirrito, Ph.D. Professor of Medicinal Chemistry Associate Professor of Neurology and Pharmacology Washington University University of Maryland, School of Medicine at St. Baltimore Louis Head, Medicinal Chemistry
Slide 46: Thank You
www.hoththerapeutics.com NASDAQ: HOTH THANK YOU Contact Information Investor Relations: LR Advisors Hoth Therapeutics, Inc. (678) 570-6791 [email protected] :HOTH 46
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