Nexalis Therapeutics Limited · ASX:NX1
Nexalis Therapeutics — InhaleRx — Investor Presentation (November 2023)
17 slides from Nexalis Therapeutics's investor presentation, Nov 22, 2023
Slide 1: Developing Tomorrow's Inhaled Therapies
ASX Webinar Presentation 22nd November 2023 DEVELOPING TOMORROW’S INHALED THERAPIES
Slide 2: Disclaimer
2 InhaleRx Ltd Investor Presentation | 22 November 2023 DISCLAIMER This presentation contains summary information about InhaleRx Limited (“InhaleRx” or “IRX” or “Company”) and its activities current as at the date of this presentation. It should be read in conjunction with InhaleRx’ other periodic a
Slide 3: Introduction
3 InhaleRx Ltd Investor Presentation | 22 November 2023 INTRODUCTION WELCOME InhaleRx Limited (ASX: IRX) (“InhaleRx” or “the Company”) is an Australian healthcare Unmet needs: company that is at the forefront of developing innovative inhaled therapeutics for the global healthcare market. 1. Inadequa
Slide 4: Targeting Unmet Clinical Needs
4 InhaleRx Ltd Investor Presentation | 22 November 2023 EXECUTIVE SUMMARY TARGETING UNMET CLINICAL NEEDS Competitive Leading Programs Clinical Focus IP and Protection Advantages and Traction • Targeting acute episodes in two • World-first development plan for • Two drug development • Provisional pat
Slide 5: Agile and Experienced Team
5 InhaleRx Ltd Investor Presentation | 22 November 2023 AGILE AND EXPERIENCED TEAM Darryl Davies Dr. Rob Jenny Sean Williams Andrew Saich Dr. John Crock Chief Executive Officer Chief Scientific Officer Non-Executive Chairman Non-Executive Director Non-Executive Director Over 17 years experience in A
Slide 6: Pain Management Market
6 InhaleRx Ltd Investor Presentation | 22 November 2023 MARKET OPPORTUNITY PAIN MANAGEMENT MARKET The pain management market is estimated to be worth $75 billion (USD) in 2023, with a CAGR 3.6% between 2023 and 2028*. • Inhaled analgesic therapies outside of a clinical setting are uncommon. • Nasal
Slide 7: Mental Health Market
7 InhaleRx Ltd Investor Presentation | 22 November 2023 MARKET OPPORTUNITY MENTAL HEALTH MARKET The global anxiety disorder treatment market is projected to reach USD 9 billion by 2030 at 2.9% CAGR during the GLOBAL ANXIETY DISORDER forecast period 2022-2030. It includes TREATMENT MARKET MENTAL HEAL
Slide 8: Unmatched Market Opportunity
8 InhaleRx Ltd Investor Presentation | 22 November 2023 UNMATCHED MARKET OPPORTUNITY All of the above formulations have been discontinued https://www.forbes.com/sites/dariosabaghi/2023/07/20/philip- morris-to-acquire-israeli-cannabis-inhaler-company-syqe- medical-for-up-to-650-million/?sh=5dec242c1f
Slide 9: Why Inhaled Therapies
9 InhaleRx Ltd Investor Presentation | 22 November 2023 WHY INHALED THERAPIES Fast speed of onset Inhaled Oral Transdermal Injectable peak effect in ~4 mins vs ~2 hours for oral Onset of Action^ Fast Slow Slow Fast Offset of Action^ Fast Slow Slow Fast Higher bioavailability >60% vs 5-9% for oral Bi
Slide 10: Efficient Drug Delivery
10 InhaleRx Ltd Investor Presentation | 22 November 2023 INHALATION EFFICIENT DRUG DELIVERY • Rapid absorption à 3-5 mins to peak blood level • Transient effect • More efficient Complete Inhalation Onset: 1 to 5 minutes absorption Duration: 1.5 to 3 hours from lungs Fast onset Inhaled Fast offset Su
Slide 11: Standard Drug Development Pathway (FDA)
11 InhaleRx Ltd Investor Presentation | 22 November 2023 STANDARD DRUG DEVELOPMENT PATHWAY (FDA) BASIC SCIENCE NONCLINICAL CLINICAL TRIALS FDA APPROVAL RESEARCH STUDIES Approved 2–5 years 1–2 years ~9 years 6 mo. – 2 years drug Research and development PHASE 1 Testing in healthy subjects (1.6 years)
Slide 12: FDA 505(b)(2) Pathway to Registration
12 InhaleRx Ltd Investor Presentation | 22 November 2023 FDA 505(B)(2)PATHWAY TO REGISTRATION Leveraging existing data reduces risk and cost 3 months 6 months 6 – 12 months 3 – 6 months Clinical Trials 12 months Device (pMDI) Preparation Phase I Phase II Phase III NDA Phase IV Feasibility Pre-IND &
Slide 13: Drug Candidate IRX211 – 3 Year Plan
13 InhaleRx Ltd Investor Presentation | 22 November 2023 DRUG CANDIDATE IRX211 – 3 YEAR PLAN UNDISCLOSED PAIN INDICATION Dronabinol based pMDI Phase I Completion of Phase 1 trial Phase I Program Initiation Commencement Phase II* of Phase I Trial Regulatory Affairs and Trial Setup Commencement of Pha
Slide 14: Drug Candidate IRX616 - 3 Year Plan
14 InhaleRx Ltd Investor Presentation | 22 November 2023 DRUG CANDIDATE IRX616 - 3 YEAR PLAN PANIC DISORDER Cannabidiol based pMDI IND submitted Program Initiation GMP Manufacture Investigational New Drug Phase II* Regulatory Affairs and Trial Setup technology transfer completed application submitte
Slide 15: Competitive Edge
15 InhaleRx Ltd Investor Presentation | 22 November 2023 COMPETITIVE EDGE Barriers to entry for potential competitors Speed to market • FDA grants minimum data exclusivity of 3 years post Low cost new drug approval date (7 years for orphan drug designation). Experienced team • This means competitors
Slide 16: Investment Opportunity
16 InhaleRx Ltd Investor Presentation | 22 November 2023 INVESTMENT OPPORTUNITY $5.55m* Market Cap $0.030* • Significant M&A potential. • IRX is currently down 70% on all time highs experienced in Feb 2021. Share Price • We have a loyal investor base with the top 20 own more than 189m 70% of the sha
Slide 17: Thank You
Thank You We welcome any further questions you may have