Hoth Therapeutics, Inc. · NASDAQ:HOTH
Hoth Therapeutics — Investor Presentation (September 2022)
39 slides from Hoth Therapeutics's investor presentation, September 2022
Slide 1: Innovating for Everyone
September 2022 Innovating for Everyone Clinical-stage biopharmaceutical company focused on next generation therapeutics meeting unmet patient needs.
Slide 2: Safe Harbor Statement
This presentation contains "forward-looking statements" within the meaning of the “safe-harbor” : HOTH provisions of the Private Securities Litigation Reform Act of 1995. These statements are identified by the use of words “could,” “believe,” “anticipate,” “intend,” “estimate,” “expect,” “may,” “con
Slide 3: Our Mission
: HOTH At Hoth Therapeutics, we strive to develop innovative, impactful, and ground-breaking treatments with a goal to improve Our patient quality of life. We are a catalyst in early-stage pharmaceutical research and development, elevating Mission promising drugs from the bench to pre-clinical and c
Slide 4: Key Investment Highlights
: HOTH Key Investment Highlights Clinical Programs Robust Pre-Clinical Development Programs Targeting Unmet Experienced Medical Needs to Management and Address Broad Market Advisory Board
Slide 5: Pipeline: Multiple Shots on Goal
: HOTH PROOF OF IND- PRODUCT DISEASE CONCEPT PRECLINICAL ENABLING PHASE 1 PHASE 2 PHASE 3 LAUNCH Pipeline: Oncology HT-KIT Mast-Cell Derived Cancers Multiple Shots on Goal Traumatic Brain HT-TBI Injury/Ischemic Stroke Neurology HT-ALZ Alzheimer’s Disease HT-001 Skin Toxicity associated with EGFR Inh
Slide 6: Primary Development
: HOTH HT-001 Topical Gel Primary Development HT-KIT Injection HT-TBI Suspension IM HT-ALZ Oral Soluble Film BioLexa Lotion
Slide 7: HT-001: Market Growth and Value Proposition
: HOTH Market Growth: EGFR Inhibitor Skin Toxicity market predicted to grow from $52M in 2018 to $391M by end of 2030* HT-001: Value Proposition Mechanism of Action: 12-week study conducted at GW suggests the topical application of HT-001 significantly reduces erlotinib-induced cutaneous toxicities
Slide 8: Recent & Upcoming Milestones: HT-001 Topical Gel
: HOTH Recent & Upcoming Milestones: HT-001 Topical Gel 2022 Jan 2022 Feb 2022 2023 IND-Enabling studies Proactive treatment of Selection of GMP IND Submission/Clinical completed in Q1 2022 EGFRI skin toxicity Manufacturer – Nuvisan Trial target for Q1 2023 demonstrated in animal Pharma February 202
Slide 9: IND-Opening Trial: CLEER-001 Phase 2a
: HOTH A Randomized, Placebo-Controlled, Parallel Phase 2a Dose Ranging Study to Investigate the Efficacy, Safety, and IND-Opening Tolerability of Topical HT-001 for the Treatment of Cutaneous Toxicities Associated with EGFR Inhibitors Trial: CLEER-001 Phase 2a 2 Parts: Dose Ranging • Part 1: Open-l
Slide 10: HT-001 505(b)(2) Development Pathway
: HOTH HT-001 Pre-IND Meeting 505(b)(2) Final Formulation Selection IND Submission Type C FDA Meeting EOP2 FDA Meeting Pre-NDA Meeting Development NDA Pathway 2021 2022 2023 Submission 2024 2025 2026 2027 Clinical Readiness: Phase 2a Phase 2b Phase 3 Clinical • Toxicology studies Clinical Clinical S
Slide 11: Proactive Topical HT-001 Significantly Reduces EGFR Inhibitor-Induced Cutaneous Toxicity
Erlotinib (noVeh C) – Week 12 : HOTH Group Change Change Compared to Compared Proactive Erlotinib to Erlotinib Only Group: Only Group: Topical HT- Facial Skin Hair Loss at Lesions at 12 12 weeks 001 weeks Significantly Erlotinib + Topical HT-001 Initiated Week 1 – Week 12 Reduces EGFR Preventati 58.
Slide 12: HT-KIT: Market Growth and Value Proposition
: HOTH Market Growth: Global systemic mastocytosis treatment revenue is $128M and projected to grow at 5.8% CAGR HT-KIT: through 2031* Value Proposition Mechanism of Action: HT-KIT is an antisense oligonucleotide that results in non-functional cKIT via mRNA frameshift.** Addresses Unmet Need: KIT D8
Slide 13: Recent & Upcoming Milestones: HT-KIT Injection
: HOTH Recent & Upcoming Milestones: HT-KIT Injection Jan 2022 Mar 2022 Q4 2022 2023 Preclinical proof of FDA Grants Orphan Drug API Manufacturing Pre-IND Submission target concept studies initiated Designation IND-enabling PK/PD for 2023 with NC State animal model studies Formulation Development
Slide 14: HT-KIT Orphan Drug Development Pathway
: HOTH HT-KIT Preclinical Dosing Studies Orphan Drug Pre-IND Meeting IND Submission Type C FDA Development Meeting Pathway 2022 2023 Pivotal Clinical 2024 2025 2026 Studies (TBD) API Clinical Readiness: Formulation Phase 1b Safety Manufacturing • Development and Preliminary In-Process • Toxicology s
Slide 15: HT-KIT Inhibits Tumor Growth in Xenograft Model
: HOTH Systemic delivery of human HT-KIT inhibits tumor growth in a humanized xenograft mast cell neoplasia model HT-KIT Figures from Douglas B. Snider1, Greer K. Arthur1, Guido H. Falduto2, Ana Olivera2, Lauren C. Ehrhardt-Humbert1, Emmaline Smith1, Cierra Smith1, Dean D. Metcalfe2 and Glenn Cruse1
Slide 16: HT-KIT Reduces Liver Infiltration of Neoplastic Mast Cells
: HOTH HT-KIT Reduces Liver Infiltration of Neoplastic Mast Cells in a Humanized Xenograft Model of Mast Cell Neoplasia Figures from Douglas B. Snider1, Greer K. Arthur1, Guido H. Falduto2, Ana Olivera2, Lauren C. Ehrhardt-Humbert1, Emmaline Smith1, Cierra Smith1, Dean D. Metcalfe2 and Glenn Cruse1
Slide 17: HT-TBI: Market Growth and Value Proposition
: HOTH Market Growth: The global stroke management market size was valued at $31.7B in 2020, and is projected to reach $67.7B HT-TBI: by 2030, registering a CAGR of 7.8% from 2021 to 2030.* Value Proposition The traumatic brain injuries treatment market to account $201.1B by 2029 by growing at a CAG
Slide 18: Upcoming Milestones: HT-TBI Suspension IM
: HOTH Upcoming Milestones: HT-TBI Suspension IM Q3 2022 Q4 2022 Q1 2023 Q2 2023 Begin formulation Injection device GMP manufacturing Pre-IND Meeting with development and evaluation and feasibility target FDA target feasibility batches for testing upcoming Pre-IND submission.
Slide 19: HT-TBI 505(b)(2) Development Pathway
: HOTH In-Process Formulation Development HT-TBI Device Pre-IND IND Type C FDA Pre-NDA Compatibility Meeting Submission Meeting Meeting 505(b)(2) Development NDA Pathway 2022 2023 Submission* 2024 2025 2026 2027 Clinical Readiness: Phase 1 Phase 3 TBI Phase 3 • Local Toxicology Comparative Clinical
Slide 20: HT-ALZ: Market Growth and Value Proposition
: HOTH 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 HT-ALZ: 2027.* Value Proposition Mechanism of Action: HT-ALZ targets Substance P** in the brain, which has both negative (
Slide 21: Recent & Upcoming Milestones: HT-ALZ Oral Soluble Film
: HOTH Recent & Upcoming Milestones: HT-ALZ Oral Soluble Film July 2022 2021 Jan 2022 2023 Chronic treatment with HT- Initiated Proof-of-Concept Initial data from WashU ALZ (>5 weeks) Oral formulation study with Alzheimer’s studies show a significant demonstrated significant development target Disea
Slide 22: HT-ALZ 505(b)(2) Development Pathway
: HOTH In-Process Chronic Dose AD HT-ALZ Mouse Model Pre-IND IND Type C FDA Studies Meeting Submission Meeting 505(b)(2) Development Continuation Pathway 2022 2023 2024 Of Clinical 2025 2026 Studies (TBD) Formulation Clinical Phase 1b Development Readiness: PK/PD • Toxicology Clinical studies Study
Slide 23: BioLexa: Market Growth and Value Proposition
: HOTH Market Growth: Atopic dermatitis market predicted to grow Biolexa: from $6.4B in 2017 to $18.3B by end of 2027* Value Proposition Mechanism of Action: Novel mixture of two previously approved compounds targeting the underlying Staphylococcus aureus infection hypothesize to potentiate Atopic D
Slide 24: Recent & Upcoming Milestones: BioLexa Lotion
: HOTH Recent & Upcoming Milestones: BioLexa Lotion 2021 Dec 2021 Sep 2022 2023 Phase 1b Cohort 1 with Phase 1b cohort in Open Label dosing Data Readout from Phase healthy subjects patients with mild to portion of Phase 1b Study 1b Clinical Study completed moderate atopic is completed dermatitis ini
Slide 25: BioLexa Phase 1b Clinical Study Design
: HOTH A Randomised, Double-Blind, Vehicle Controlled, Sequential Group Study to Determine the Safety, Tolerability, BioLexa Pharmacokinetics and Efficacy of Twice Daily Application of Phase 1b Topical BioLexa™ in Adult Healthy Subjects and Patients with Mild to Moderate Atopic Dermatitis Clinical S
Slide 26: BioLexa: Proof-of-Concept Results
: HOTH This study concluded that the combination of gentamicin and Ca-DTPA is more effective to reduce bacteria growth and inhibit BioLexa: the formation of biofilms than each compound individually. Proof-of- Concept Results DTPA Alone Gentamicin Combination Reduced Bacteria Below LOQ Alone Miller S
Slide 27: Preclinical Development: HT-003, HT-004, Direct Detect Breath
: HOTH Preclinical HT-003 Development HT-004 Direct Detect Breath Diagnostic Device
Slide 28: HT-003: Market Growth and Value Proposition
: HOTH 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 HT-003: Treatment market was valued at USD 15.87 billion by 2019, Value Proposition growing with 4.1% CAGR during the
Slide 29: HT-003D: Dermal Preclinical Study Results
: HOTH HT-003D: 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
Slide 30: HT-003IBD: Ulcerative Colitis Ex Vivo Tissue Results
Study : HOTH Results Ex Vivo Tissue (n = 2 donors) Preclinical HT-003IBD: Ulcerative Colitis U U ns IL-17alpha release ns IL-22 release tim tim (% Control) ul (% Control) ul at at ed 100 150 0 50 ed 100 150 200 250 0 50 co co nt nt r r ol ol Ve Ve hi hi cl cl e B e B IR IR B B C 79 C 7 FW 6 FW 96 00
Slide 31: HT-003IBD: Crohn's Ex Vivo Tissue Results
Tissue Study : HOTH Results (n = 1 donor) Preclinical Crohn’s Ex Vivo HT-003IBD: U ns tim IL-17alpha release ul (% Control) at ed 100 150 0 50 co nt ol r Ve hi cl B e IR B C 79 FW 6 00 C 1/ 0 FW 1 00 C 1 FW /02 00 C 1 FW /03 00 1/ 04 U ns tim IL-22 release ul (% Control) at ed 100 150 0 50 co nt r o
Slide 32: HT-004: Market Growth and Value Proposition
: HOTH HT-004: Market Growth: The global asthma therapeutics market reached a value of $17.6B in 2020. The market is expected to Value Proposition reach a value of $19.13B by 2026, expanding at a CAGR of 1.60% during 2021-2026.* Mechanism of Action: Target IgE receptor trafficking to prevent downstr
Slide 33: HT-004: Asthma & Allergic Inflammation
: HOTH • Peribronchiolar Inflammation was reduced HT-004: by inhalation of HT-004 that targets FcER1- beta alternative exon splicing. Asthma & n.s. • Ovalbumin inhalation induced airway- Allergic **** centric recruitment of inflammatory cells predominated by eosinophils admixed with Bronchiolar infl
Slide 34: Breath Detect Diagnostic Device
: HOTH Sensor on Chip Breath Detect Diagnostic Device Breath Collection Tube
Slide 35: Direct Detect Breath Diagnostic Device System: Value Proposition
: HOTH ✓ Technology can be developed for home use by patients or Direct Detect lay users for rapid, large-scale screening Breath ✓ Breath samples can be collected easily and noninvasively Diagnostic without additional sample collection devices or sample processing Device ✓ Results available in a tim
Slide 36: Market Overview: Point of Care Market
: HOTH Market Overview: Attractive Opportunities in the Point of Care Market 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, H
Slide 37: Investment Highlights
• Addressing multi-billion-dollar unmet market opportunities across indications : HOTH Two Programs in Clinical Stage • BioLexa Lotion - Novel mixture of two FDA-approved compounds – in of Development clinical phase of development Investment • HT-001 – no approved product/competitor currently on the
Slide 38: Management Team
: HOTH Management Team Robb Knie Stefanie Johns, Ph.D. Chief Executive Officer Chief Scientific Officer David Briones Hayley Springer Chief Financial Officer Executive Vice President, Operations
Slide 39: Thank You
: HOTH Thank You. Contact Information Investor Relations: LR Advisors Hoth Therapeutics, Inc. (678) 570-6791 investorrelations@hoththerapeutics.com : HOTH
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