Hoth Therapeutics, Inc. · NASDAQ:HOTH
Hoth Therapeutics — Investor Presentation (August 2023)
33 slides from Hoth Therapeutics's investor presentation, August 2023
Slide 1: Innovating for Everyone
August 2023 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 2022 Feb 2023 Sept 2023 2024 IND Approved for Phase First clinical site activated All PK sites active and Data from PK Cohort & 2a Clinical Trial and enrollment active enrolling start of Double Blind Randomized Cohort
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 2 Parts: 2a Dose Ranging • Part 1: Open-l
Slide 10: HT-001 505(b)(2) Development Pathway
: HOTH HT-001 IND 505(b)(2) Submission Type C FDA EOP2 FDA Pre-NDA Meeting Meeting Meeting Development NDA Pathway Submission 2022 2023 2024 2025 2026 2027 2028 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 Compared Proactive to 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 Preventati 58.5% Re
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 Sept 2023 Dec 2023 Jan 2024 2024 Pre-IND Submission target API Manufacturing IND-enabling animal IND Submission target for completed & Formulation model studies 2024 initiated
Slide 14: HT-KIT Orphan Drug Development Pathway
: HOTH HT-KIT Preclinical Orphan Drug Dosing Studies Pre-IND Meeting IND Submission Type C FDA Development Meeting Pathway Pivotal Clinical 2023 2024 2025 2026 Studies (TBD) API Clinical Readiness: • Formulation Phase 1b Safety Manufacturing Development and Preliminary In-Process • Toxicology studie
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 Substance P** in the brain, which has both negative (
Slide 18: Recent & Upcoming Milestones: HT-ALZ Oral Soluble Film
: HOTH Recent & Upcoming Milestones: HT-ALZ Oral Soluble Film 2021 July 2023 Sept 2023 Q4 2023 Initiated Proof-of-Concept Chronic dose ranging Additional study at WashU Oral formulation study with Alzheimer’s studies completed at to evaluate levels of total development target Disease leader, Washing
Slide 19: HT-ALZ 505(b)(2) Development Pathway
: HOTH In-Process HT-ALZ Chronic Dose AD Mouse Model Pre-IND IND Type C FDA 505(b)(2) Studies Meeting Submission Meeting Development Continuation Pathway Of 2022 2023 2024 2025 2026 Clinical 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 Clinical Mild to Moderate Atopic Dermatitis S
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 BioLexa: inhibit the formation of biofilms than each compound Proof-of- individually. 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 Preclinical Study Results
Study : HOTH Results Ex Vivo Tissue Preclinical (n = 2 donors) 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 Preclinical Study Results
Tissue Study : HOTH Results (n = 1 donor) Crohn’s Ex Vivo Preclinical 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 Inflammation Bro
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 by 2030, registering a CAGR of 7.8% from 2021 to HT-TBI: 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 Two Programs indications : HOTH in Clinical • BioLexa Lotion - Novel mixture of two FDA-approved compounds – Stage of in clinical phase of development Development Investment • HT-001 – no approved product/competitor currently on the
Slide 33: 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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