Nexalis Therapeutics Limited · ASX:NX1
Nexalis Therapeutics — InhaleRx — Shareholder Meeting (May 2024)
33 slides from Nexalis Therapeutics's shareholder meeting presentation, May 30, 2024
Slide 1: Annual General Meeting
ANNUAL GENERAL MEETING May 2024
Slide 2: Welcome and Agenda
WELCOME AND AGENDA Online attendees • If you have an IT-related issue, please click on the “Raise Hand” button • If there is a question relating to a resolution, shareholders can ask questions by clicking on the Q&A button and typing in your question • General questions (or not relating to the resol
Slide 3: 2023 Financial Statements
2023 FINANCIAL STATEMENTS To receive and to consider the Annual Financial Report of the Company for the financial year ended 31 December 2023 together with the declaration of the Directors, the Directors’ Report, the Remuneration Report and the Auditor’s Report for that financial year. As required b
Slide 4: Resolution 1
RESOLUTION 1 To consider and, if thought fit, to pass the following Resolution as a non-binding, advisory ordinary resolution: “That, for the purpose of Section 250R(2) of the Corporations Act and for all other purposes, approval is given for the adoption of the Remuneration Report as contained in t
Slide 5: Resolution 2
RESOLUTION 2 To consider and, if thought fit, to pass the following Resolution as an ordinary resolution: “That James Barrie, a Director appointed as an additional Director and holding office until the next general meeting of the Company after his appointment in accordance with clause 108 of the Com
Slide 6: Resolution 3
RESOLUTION 3 To consider and, if thought fit, to pass the following Resolution as an ordinary resolution: “That Sean Williams, a Director who retires by rotation in accordance with clause 104.2(d) of the Constitution and ASX Listing Rule 14.2, and being eligible, is elected as a Director.” VALID PRO
Slide 7: Resolution 4
RESOLUTION 4 To consider and, if thought fit, to pass the following Resolution as a special resolution: “That, for the purposes of ASX Listing Rule 7.1A and for all other purposes, the Shareholders approve the issue of Equity Securities up to 10% of the issued capital of the Company (at the time of
Slide 8: Resolution 5
RESOLUTION 5 To consider and, if thought fit, to pass the following Resolution as an ordinary resolution: “That, for the purposes of ASX Listing Rule 10.14 and for all other purposes, the Shareholders of the Company approve the issue and allotment of 2,000,000 unlisted Options, exercisable at $0.15
Slide 9: Resolution 6
RESOLUTION 6 To consider and, if thought fit, to pass the following Resolution as an ordinary resolution: “That, for the purposes of Listing Rule 10.1, and for all other purposes, Shareholders approve the appointment of Ingenu CRO Pty Ltd, a related party of the Company as the Contract Research Orga
Slide 10: Poll and Meeting Formally Closed
POLL Poll opened by the Chair • Click on “For”, “Against” or “Abstain”, then click “Next” to move to the next resolution • Shareholders and visitors who are not voting, click “Skip Poll” Poll closed by the Chair Results will be released on ASX shortly after conclusion of the AGM MEETING FORMALLY CLO
Slide 11: Business Update
f . > “< . XY i . - BUSINESS UPDATE AGM May 2024
Slide 12: Developing Tomorrow's Inhaled Therapies Today
Annual General Meeting Presentation 30th May 2024 DEVELOPING TOMORROW’S INHALED THERAPIES TODAY
Slide 13: Disclaimer
InhaleRx Ltd AGM Presentation | 30th May 2024 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 continu
Slide 14: A Year of Significant Progress
3 InhaleRx Ltd AGM Presentation | 30th May 2024 A YEAR OF SIGNIFICANT PROGRESS New Clinical Development Focus Strategy Lean, agile and focused FDA505(b)(2) with FDA Regulatory Roadmap to NDA defined confirmed Phase 1 (211) complete Operational Execution All preparations for the Ph2 trials establishe
Slide 15: About InhaleRx
4 InhaleRx Ltd AGM Presentation | 30th May 2024 ABOUT INHALERX I n h a l e R x L i m i t e d (A S X : I R X ) (“ I n h a l e R x ” o r “the Company”) is a clinical stage biotechnology development company focused on developing innovative inhaled therapeutics to address unmet medical needs in pain man
Slide 16: Strategy
5 InhaleRx Ltd AGM Presentation | 30th May 2024 STRATEGY Focus on Pain Focus on Inhalation Drug Management Device Development Focus on Mental Health Focus on operational execution
Slide 17: Our Approach
6 InhaleRx Ltd AGM Presentation | 30th May 2024 OUR APPROACH Agile and responsive to Speed to market pivot opportunities Pursuing the path of least resistance
Slide 18: Pain Candidate – IRX-211
7 InhaleRx Ltd AGM Presentation | 30th May 2024 PAIN CANDIDATE – IRX-211 • Breakthrough Pain is the first pain indication that IRX is targeting. • Phase 1 complete with Clinical Study Report expected in Q2. • No SAE's and promising drug absorption data. • Pre-IND complete, IND submission will requir
Slide 19: The Pain Opportunity
8 InhaleRx Ltd AGM Presentation | 30th May 2024 THE PAIN OPPORTUNITY 3.59% CAGR* * https://www.mordorintelligence.com/industry-reports/pain-management-market https://www.economist.com/graphic-detail/2021/03/30/opioid-deaths-in-america-reached-new-highs-in-the-pandemic
Slide 20: Breakthrough Cancer Pain (BTcP) in Cancer Patients
9 InhaleRx Ltd AGM Presentation | 30th May 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 itself. experience pain Breakthrough pain - transient flare of pain occurring in opioid-tolerant patients e
Slide 21: Developing IRX-211 as a Therapeutic Agent
10 InhaleRx Ltd AGM Presentation | 30th May 2024 DEVELOPING IRX-211 AS A THERAPEUTIC AGENT IRX-211 will be a registered prescription-only medication. InhaleRx investment into clinical trials to show safety and efficacy. Regulatory approval(s) will allow InhaleRx to make a marketing claim. Access to
Slide 22: IRX-211 Commercial Considerations
11 InhaleRx Ltd AGM Presentation | 30th May 2024 1 Large patient population approx. 1.8 million in USA. 2 Estimated total addressable market in USA of approximately of $93.19b by 2029 IRX-211 COMMERCIAL CONSIDERATIONS Growing demand / widening gap in the 3 market for a non-opioid therapeutic option
Slide 23: Regulatory Comparisons
12 InhaleRx Ltd AGM Presentation | 30th May 2024 REGULATORY COMPARISONS Year of Number of Pivotal Medication Name Trade Name Pivotal Endpoint Status Approval Efficacy Clinical Trials Fentanyl citrate oral Change in pain intensity from transmucosal Actiq baseline at 30 minutes post-dose 1998 2 Active
Slide 24: Mental Health Candidate – IRX616a
13 InhaleRx Ltd AGM Presentation | 30th May 2024 MARKET OPPORTUNITY AND STATUS UPDATE MENTAL HEALTH CANDIDATE – IRX616a • Panic Disorder is the first mental health indication that IRX is targeting. • Pre-IND meeting with FDA complete and provided confidence regarding our endpoints. • Phase 2 ethics
Slide 25: The Mental Health Opportunity
14 InhaleRx Ltd AGM Presentation | 30th May 2024 THE MENTAL HEALTH OPPORTUNITY 5.32% CAGR BY 2029* https://www.mordorintelligence.com/industry-reports/pain-management-market https://www.who.int/news/item/02-03-2022-covid-19-pandemic-triggers-25-increase-in-prevalence-of-anxiety-and-depression-worldw
Slide 26: Panic Disorder (PD)
15 InhaleRx Ltd AGM Presentation | 30th May 2024 PANIC DISORDER (PD) Anxiety Disorders - are the World's most common mental disorders, affecting 301m people in 2019*. 1 in 4 Diagnosed Panic Disorder- Panic disorder is a type of anxiety disorder characterised by recurrent panic attacks, which receive
Slide 27: Developing IRX-616a as a Therapeutic Agent
16 InhaleRx Ltd AGM Presentation | 30th May 2024 DEVELOPING IRX-616a AS A THERAPEUTIC AGENT IRX-616a will be a registered prescription-only medication. InhaleRx investment into clinical trials to show safety and efficacy. Regulatory approval(s) with the FDA will allow Inhalerx to make a marketing cl
Slide 28: IRX-616a Commercial Considerations
17 InhaleRx Ltd AGM Presentation | 30th May 2024 1 There are no FDA approved drugs for treating Panic Disorder via inhalation. 2 Total Addressable Market is the USA alone is expected to grow to 27.87b by 2029. IRX-616a COMMERCIAL Existing drugs like SSRI’s can affect sleep, CONSIDERATIONS 3 sexual
Slide 29: Regulatory Comparisons
18 InhaleRx Ltd AGM Presentation | 30th May 2024 REGULATORY COMPARISONS Year of Medication Name Trade Name Pivotal Endpoint Status Approval Reduction in panic attack Fluoxetine Prozac frequency and severity 1987 Active Reduction in panic attack Paroxetine Paxil frequency and severity 1992 Active Red
Slide 30: Clinical Pipeline – May 2024
19 InhaleRx Ltd AGM Presentation | 30th May 2024 CLINICAL PIPELINE – MAY 2024 3 months 6 months 6 – 12 months 3 – 6 months Clinical Trials (3-5 years) 12 months IRX211 May 2024 Device (pMDI) Preparation NDA Phase I Phase II Studies Feasibility & Formulation Pre-IND for Clinical Phase III Studies Sub
Slide 31: Outlook
20 InhaleRx Ltd AGM Presentation | 30th May 2024 OUTLOOK • Focus on carefully selected clinical indications that represent a significant commercial opportunity. • Trials have been all costed and capital management initiatives to fund these plans are progressing. • Accelerated clinical development vi
Slide 32: Thank You
THANK YOU We welcome any further questions you may have Darryl Davies CEO Dr Sud Agarwal Medical Advisor
Slide 33: General Q&A
GENERAL Q&A AGM May 2024