Nexalis Therapeutics Limited · ASX:NX1
Nexalis Therapeutics — InhaleRx — Corporate Update (March 2024)
18 slides from Nexalis Therapeutics's corporate update, Mar 20, 2024
Slide 1: Shareholder Town Hall Webinar Slides
20 March 2024 ASX Announcement SHAREHOLDER TOWN HALL WEBINAR SLIDES InhaleRx Ltd (ASX: IRX), (“InhaleRx”, “IRX” ‘or “the Company”) an Australian healthcare company developing unique inhaled medicinal drug-device products to address unmet medical needs in pain management and mental health sectors, is
Slide 2: About InhaleRx Limited (ASX: IRX)
About InhaleRx Limited (ASX: IRX) – www.inhalerx.com.au InhaleRx Limited is an Australian healthcare company which is developing unique medicinal drug-device products to address unmet medical needs in pain management and mental health sectors. The overarching goal is to pursue U.S. FDA approval and
Slide 3: Developing Tomorrow's Inhaled Therapies
ASX Webinar Presentation 20th March 2024 DEVELOPING TOMORROW’S INHALED THERAPIES
Slide 4: Disclaimer
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 and continuous disclosure announcements filed with the Au
Slide 5: Introduction
3 InhaleRx Ltd Investor Presentation | 20th March 2024 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. Inadequat
Slide 6: Why Inhaled Therapies
4 InhaleRx Ltd Investor Presentation | 20th March 2024 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 Bio
Slide 7: Efficient Drug Delivery
5 InhaleRx Ltd Investor Presentation | 20th March 2024 INHALATION EFFICIENT DRUG DELIVERY • Rapid absorption 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 Sublin
Slide 8: Pain Market Opportunity and Status Update
6 InhaleRx Ltd Investor Presentation | 20th March 2024 $75 PAIN MARKET OPPORTUNITY AND STATUS UPDATE PAIN CANDIDATE - IRX211 UPDATE billion • Breakthrough Pain is the first pain indication that (USD) IRX is targeting. IN 2023 • Phase 1 complete with Clinical Study Report expected in Q2. • No SAE's a
Slide 9: Breakthrough Cancer Pain (BTcP)
7 InhaleRx Ltd Investor Presentation | 20th March 2024 BREAKTHROUGH CANCER PAIN (BTcP) 1 in 2 Cancer Patients Cancer pain - caused by primary cancer, metastases or as a result of the cancer treatment experience pain itself. Breakthrough pain - transient flare of pain occurring in opioid-tolerant pat
Slide 10: The Opioid Crisis
8 THE OPIOD CRISIS • In 2018, the FDA put in place strict Risk Mitigation Strategies (REMS) for prescribing rapid-acting fentanyl products*. • Harms must be weighed by side effects and drug misuse which are indirect costs to society and patients. • Reasons for limiting the use of fentanyl in clinica
Slide 11: The Gravity of the Opioid Problem
9 InhaleRx Ltd Investor Presentation | 20th March 2024 THE GRAVITY OF THE OPIOD PROBLEM
Slide 12: Dronabinol (Δ9-THC) for BTcP
10 InhaleRx Ltd Investor Presentation | 20th March 2024 DRONABINOL (Δ9-THC) FOR BTcP 20%-40% Only a few small interventional studies have studied U.S. cancer patients inhaled THC for pain, e.g. reporting cannabis use to help treat their condition • Almog, et al. (2020) - Inhalation of 0.5 mg or 1mg,
Slide 13: Commercial Considerations
11 InhaleRx Ltd Investor Presentation | 20th March 2024 1 Large patient population approx. 1.8 million in USA. 2 Estimated total addressable market in USA of approximately US$4.2 billion. COMMERCIAL 3 CONSIDERATIONS Growing demand / widening gap in the market for a non-opioid therapeutic option. 4 R
Slide 14: Regulatory Comparisons
12 InhaleRx Ltd Investor Presentation | 20th March 2024 REGULATORY COMPARISONS Year of Number of Pivotal Medication Name Trade Name Pivotal Endpoint Peak Year Sales Status Approval Efficacy Clinical Trials Fentanyl citrate oral Change in pain intensity from transmucosal Actiq baseline at 30 minutes
Slide 15: Path to Registration (FDA NDA)
13 InhaleRx Ltd Investor Presentation | 20th March 2024 PATH TO REGISTRATION (FDA NDA) Following in the footsteps of existing approvals Leveraging existing data via FDA’s 505(b)(2) reduces risk, time and cost 6 months 6 – 12 months 3 – 6 months Clinical Trials 12 months 3 months IRX211 March 2024 De
Slide 16: Market Opportunity and Status Update: IRX616a
14 InhaleRx Ltd Investor Presentation | 20th March 2024 MARKET OPPORTUNITY AND STATUS UPDATE MENTAL HEALTH CANDIDATE – IRX616a UPDATE • Panic Disorder is the first mental health indication that IRX is targeting. GLOBAL ANXIETY DISORDER TREATMENT MARKET • Phase 2 ethics re-submission, requirement to
Slide 17: Corporate Summary
15 InhaleRx Ltd Investor Presentation | 20th March 2024 CORPORATE SUMMARY $9.49m* Market Cap • Evidence of significant share price recovery, over • 66% recovery in the last month. Significant M&A potential with both big pharma and/or big tobacco. $0.050* Share Price • Loyal investor base - top 20 ow
Slide 18: Thank You
Thank You We welcome any further questions you may have Darryl Davies darryl.davies@inhalerx.com.au