Nexalis Therapeutics Limited · ASX:NX1
Nexalis Therapeutics — InhaleRx — Shareholder Meeting (November 2024)
30 slides from Nexalis Therapeutics's shareholder meeting presentation, Nov 28, 2024
Slide 1: General Meeting
GENERAL MEETING 4.00pm AEDT, Thursday 28 November 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: Resolution 1
RESOLUTION 1 To consider and, if thought fit, to pass the following Resolution as an ordinary resolution: “That, for the purposes of Listing Rule 10.11 and for all other purposes, approval is given for the Company to issue up to the equivalent of $24,815.45 of Shares in lieu of Directors’ Fees for t
Slide 4: Resolution 2
RESOLUTION 2 To consider and, if thought fit, to pass the following Resolution as an ordinary resolution: “That, for the purposes of Listing Rule 10.11 and for all other purposes, approval is given for the Company to issue up to the equivalent of $26,250 of Shares in lieu of Directors’ Fees for the
Slide 5: Resolution 3
RESOLUTION 3 To consider and, if thought fit, to pass the following Resolution as an ordinary resolution: “That, for the purposes of Listing Rule 10.11 and for all other purposes, approval is given for the Company to issue up to the equivalent of $16,500 of Shares in lieu of Directors’ Fees for the
Slide 6: Resolution 4
RESOLUTION 4 To consider and, if thought fit, to pass the following Resolution as an ordinary resolution: “That, for the purposes of Listing Rule 10.11 and for all other purposes, approval is given for the Company to issue up to the equivalent of $8,325 of Shares in lieu of Directors’ Fees for the p
Slide 7: 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 7.4 and for all other purposes, Shareholders ratify the issue of 3,444,828 Shares at $0.029 per Share on the terms and conditions set out in the Expla
Slide 8: Resolution 6
RESOLUTION 6 To consider and, if thought fit, to pass the following Resolution as an ordinary resolution: “That, for the purposes of ASX Listing Rule 7.4 and for all other purposes, Shareholders ratify the issue of 17,969,880 Shares at a deemed price of $0.023 per Share on the terms and conditions s
Slide 9: Resolution 7
RESOLUTION 7 To consider and, if thought fit, to pass the following Resolution as an ordinary resolution: “That, for the purposes of Listing Rule 7.1 and all other purposes, approval is given for the Company to issue 38,449,145 Options to Clendon Biotech Capital Pty Ltd (Clendon) under the Facility
Slide 10: Poll / 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
BUSINESS UPDATE General Meeting – 28 November 2024
Slide 12: General Q&A
GENERAL Q&A General Meeting – 28 November 2024
Slide 13: Developing Tomorrow's Inhaled Therapies
Extraordinary General Meeting 28th November 2024 DEVELOPING TOMORROW’S INHALED THERAPIES
Slide 14: Disclaimer
InhaleRx Ltd EGM 28th November 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 continuous disclo
Slide 15: About InhaleRx
3 InhaleRx Ltd EGM 28th November 2024 ABOUT INHALERX InhaleRx Limited (ASX: IRX) is a clinical stage biotechnology development company focused on developing innovative inhaled therapeutics to address unmet medical needs in pain management and mental health treatment. Two drug/device candidates Provi
Slide 16: Developing IRX-211 as a Therapeutic Agent
4 InhaleRx Ltd EGM 28th November 2024 DEVELOPING IRX-211 AS A THERAPEUTIC AGENT IRX-211 will be a registered prescription-only medication to treat Breakthrough Cancer Pain (BTcP). Ph1 1 clinical trial complete, very promising insights and no SAE’s. Ph2 approved by HREC to demonstrate safety and effi
Slide 17: Planning to Commence IRX-211
InhaleRx Ltd EGM 28th November 2024 PLANNING TO COMMENCE IRX-211 MILESTONE COMPLETE EXPECTED (QUARTER) Funding Secured Recut of trial design Tender Commenced Spec Work Commenced Component Sourcing HREC Approval for Ph2 trial Protocol Amendment with HREC Q1 Batch Manufacturing Complete Q1 First Patie
Slide 18: $9b IRX-211 Commercial Opportunity
6 InhaleRx Ltd EGM 28th November 2024 By 2040, the global cancer burden $9b Total Addressable 1 is projected to reach approximately 29.5 million new cases annually. Large patient population approx. 1.8 Market (TAM) for the Cancer Pain Market by million in USA alone. 2028. 20%-40% U.S. cancer patient
Slide 19: Developing IRX-616a as a Therapeutic Agent
7 InhaleRx Ltd EGM 28th November 2024 DEVELOPING IRX-616a AS A THERAPEUTIC AGENT IRX-616a will be a registered prescription-only medication to treat Panic Disorder. Preparing for a Ph1 HREC submission, this trial will be followed by a Ph2 to demonstrate safety and efficacy in the Panic Disorder pati
Slide 20: Planning to Commence IRX-616a
InhaleRx Ltd EGM 28th November 2024 PLANNING TO COMMENCE IRX-616a MILESTONE COMPLETE EXPECTED (QUARTER) Funding Secured Medical writing complete Tender Commenced Spec Work Commenced Component Sourcing Tender complete Q1 HREC Application Q1 HREC Approval Q1 Batch Manufacturing Complete Q2 First Patie
Slide 21: $13.3b IRX-616a Commercial Opportunity
9 InhaleRx Ltd EGM 28th November 2024 There are currently no FDA $13.3b USD 1 approved drugs for treating Panic Disorder via inhalation. Total Addressable Market (TAM) for anxiety disorders and depression treatments by 2027. Covid-19 triggered a 25% increase 2 in prevalence, median onset age of 24.
Slide 22: Pathway to Registration (FDA NDA)
10 InhaleRx Ltd EGM 28th November 2024 PATHWAY 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 3 months 6 months 6 – 12 months 3 – 6 months Clinical Trials 12 months IRX211 Nov 2024 Device (pMDI) Prep
Slide 23: Highlights & Summary
11 InhaleRx Ltd EGM 28th November 2024 HIGHLIGHTS & SUMMARY Tender process underway for Ph2 (211) and Ph1 (616a), and non-clinical is being mapped out in consultation with Clendon Capital. This step is not impacting the critical path. Slashed Cash Burn and recent change to BOD by over 70% since Janu
Slide 24: Thank You
THANK YOU Please contact me at: Darryl Davies darryl.davies@inhalerx.com.au
Slide 25: IRX - Clinical Trial Analysis
IRX - Clinical Trial Analysis T his pre se n tatio n e xplo r es ke y fac tor s in flue nc ing c lin ical t rial su cc e ss, fo cu sin g on IRX 21 1 and IR X61 6. We ' ll e xam in e the ir appro v al path way s, e ffic ie nt t rial de s igns, and m ar ke t po te ntial.
Slide 26: IRX211: Breakthrough Cancer Pain
SPID-30 Endpoint FDA requires 1-point improvement on SPID-30 scale as primary endpoint. Unmet Need BTcP has limited non-opioid options, making modest efficacy highly valuable. IRX211 Advantages Non-opioid formulation eliminates IRX211: risks like dependency and respiratory depression. BREAKTHROUGH S
Slide 27: IRX616: Panic Disorder Approval Strategy
I RX6 1 6: PA NIC DI SO RD ER A PPR OVA L STR ATE GY Lorem ipsum dolor sit amet, PDS S E NDPOI NT RI S K-BE NE F IT I NHA LED CB D C consectetur adipiscing elit. OM PET I T IV E Suspendisse AG E tincidunt augue. NuncEsed DGE quis enim pretium, bibendum ante Measures panic attack PRO FI LE A DVANT ul
Slide 28: Efficient Clinical Trial Design
EFFICIENT E ffica cy E nd po int St u dy CLINICAL I RX 21 1 : SP ID -3 0 as s ol e pr i mar y e ndpo i n t. I RX 61 6 : Fo cu se d o n PDS S e n dpoi n t. TRIAL Le ver a g ing P r ior Da t a DESIGN • Ut il i ze s pr e-e xi s ti n g c ann abi n oi d s afe ty an d ph ar mac ok i ne t i c data. • Re du
Slide 29: Insurance Claimability and Market Access
IN SURAN CE CL AIMABIL IT Y AND MARK ET ACCE SS FDA Approval Advantage Market Implications Physician Adoption FDA-approved therapies are IRX211 and IRX616 positioned for FDA sanctioning builds prescriber insurance-eligible, enabling payer adoption and widespread confidence and encourages broader pat
Slide 30: Conclusion: Optimized Approval Pathways
CO N CL US I ON : OP TI M I ZED AP P ROVAL PA T HWA YS FDA Approval Streamlined path with focused endpoints and single pivotal study strategy. Risk-Benefit Profile Strong profiles for both IRX211 and IRX616. Market Readiness Insurance-backed, FDA-approved options positioned to disrupt markets. "IRX2