Hoth Therapeutics, Inc. · NASDAQ:HOTH
Hoth Therapeutics — Investor Presentation (December 2024)
33 slides from Hoth Therapeutics's investor presentation, December 2024
Slide 1: Innovating for Everyone
December 2024 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-ALZ Oral Soluble Film BioLexa Lotion
Slide 7: HT-001: 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 Q1 2023 Q4 2024 Q1 2025 Q3 2025 Initiated Phase 2a Clinical All Clinical Sites Active Initial Interim Open Label Full Data Set for Open Trial in Open Label Cohort and Enrolling in Open PK Cohort Data Label PK Cohort Label and Double-Blind Rando
Slide 9: IND-Opening Trial: CLEER-001 Phase 2a Dose Ranging Study
: 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 – Parallel Study Design: Dose
Slide 10: HT-001 505(b)(2) Development Pathway
: HOTH HT-001 IND 505(b)(2) Submission Type C FDA Meeting EOP2 FDA Meeting Pre-NDA Meeting Development NDA Pathway 2023 2024 2025 Submission 2026 2027 2028 2029 Phase 2b Phase 3 Phase 2a Clinical Study Clinical Study Clinical (US only) Study(s) (TBD) In-Process Registration Chronic Toxicology Batche
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: 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 Q4 2023 Q1 2024 Q1 2025 Q4 2025 Pre-IND Meeting with FDA IND-enabling animal GLP animal studies and IND Submission target and strategy confirmed toxicology studies initiated GMP API manufacturing initiation target
Slide 14: HT-KIT Orphan Drug Development Pathway
: HOTH HT-KIT Preclinical Dosing Pre-IND Orphan Drug Studies Meeting IND Submission Type C FDA Development Meeting Pathway 2023 Pivotal Clinical 2024 2025 2026 Studies (TBD) API Clinical Readiness: Phase 1b Safety Manufacturing • Formulation and Preliminary Development Efficacy Study in • Toxicology
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-ALZ: 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 the Substance P/Neurokinin-1 Receptor pathway** in th
Slide 18: Recent & Upcoming Milestones: HT-ALZ Oral Soluble Film
: HOTH Recent & Upcoming Milestones: HT-ALZ Oral Soluble Film Q2 2024 Q3 2024 Q3 2024 2025 HT-ALZ Formulation Work US Patent Office Awarded Preclinical Studies Pre-IND Meeting initiated HT-ALZ Patent completed at WashU Submission
Slide 19: 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 2023 2024 2025 Of Clinical 2026 2027 Studies (TBD) Formulation Clinical Phase 1b Development Readiness: PK/PD • Toxicology Clinical studies Study
Slide 20: BioLexa: 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 21: 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 22: 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 St
Slide 23: 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 24: Preclinical Development: HT-003, HT-004, HT-TBI
: HOTH Preclinical HT-003 Development HT-004 HT-TBI
Slide 25: HT-003: 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 26: 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 27: 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 28: HT-003IBD: Crohn's Ex Vivo Tissue Study 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 29: HT-004: 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 30: 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 31: HT-TBI: 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 32: Investment Highlights
• Addressing multi-billion-dollar unmet market opportunities across indications : HOTH Programs in Clinical Stage of • HT-001 – no approved product/competitor currently on the market, Development clinical trial currently enrolling Investment • HT-KIT – Pre-IND Meeting with FDA successful and IND-ena
Slide 33: Thank You.
: HOTH Thank You. Contact Information Investor Relations: Hoth Therapeutics, Inc. investorrelations@hoththerapeutics.com : HOTH
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