Firebrick Pharma Limited · ASX:FRE
Firebrick Pharma — Shareholder Meeting (November 2022)
28 slides from Firebrick Pharma's shareholder meeting presentation, Nov 23, 2022
Slide 1: AGM Presentation
For personal use only AGM Presentation Executive Chairman, Peter Molloy
Slide 2: Important Notice and Disclaimer
IMPORTANT NOTICE AND DISCLAIMER This presentation is provided for information purposes only. The information in this presentation is in a summary form, does not purport to be complete and is not intended to be relied upon as advice For personal use only to investors or other persons. The information
Slide 3: Firebrick Pharma (ASX:FRE)
Firebrick Pharma (ASX:FRE) For personal use only Nasodine® Nasal Spray Potential for strong market adoption Breakthrough treatment for the common cold Up to 20 billion colds p.a. worldwide The first nasal spray medicine that actually targets the viral cause of colds Consumer research pre
Slide 4: Key Projects for 2022/23
Key Projects for 2022/23 For personal use only Phase 3 clinical trial Phase 2 clinical trial AAT appeal to gain Partnering of of Nasodine for of Nasodine for approval of Nasodine Nasodine in US and common cold COVID-19 in Australia Europe Confirmatory trial to Investigates impact of Appeal against T
Slide 5: Phase 3 common cold clinical trial update
For personal use only Phase 3 common cold clinical trial update Trial started recruiting in May 2022 Now 50% recruited, paused over summer to resume in 2023 5
Slide 6: Phase 3 common cold trial (FBP-006)
Phase 3 common cold trial (FBP-006) Confirmatory Phase III study of Nasodine Nasal Spray (povidone-iodine 0.5%) as For personal use only a symptomatic treatment for early stage common cold in the natural setting Primary endpoint (primary/definitive measure of efficacy) ITT1 Inclusion criteria: = GSS
Slide 7: Phase 3 trial status update
Phase 3 trial status update For personal use only The study is 51% recruited 100 subjects in ITTi (target is ITTi Total Performance ITT Cumulative Recruitment 196) by Site Location by Month and Site Location 90 120 218 subjects in ITT so far, so 115 virus positivity rate (net of 80 100 SARS-Co
Slide 8: Comments on the trial performance so far
Comments on the trial performance so far For personal use only Despite the late start at 4 sites and the poor overall performance in VIC, all other aspects of the trial are performing well The protocol is being executed well The webapp is working well (cloud-based tool for reporting patient ou
Slide 9: Benefits of the summer pause
Benefits of the summer pause For personal use only Time to rationalise and optimise sites: 5 sites to continue in 2023 We will continue with he top performing South Australian site (CMAX) and the 3 best South African sites A new site will be used in Victoria (Barwon Health, Geelong), and after
Slide 10: Viral aetiology in trial subjects so far
For personal use only Viral aetiology in trial subjects so far While clinical efficacy will not be assessed during the pause (because it would affect the statistical integrity of the study), we can report the pattern of virus detections for all recruited subjects who were PCR-positive for a respirat
Slide 11: Virus profile (so far) in common cold trial
Virus profile (so far) in common cold trial Based on 113 subjects who were PCR-positive for a respiratory virus For personal use only Australia: Detections, 72 subjects South Africa: Detections, 41 subjects Seasonal coronaviruses1 HMPV Parainfluenza RSV 4% 4% (non-SARS) were the primary 5% Influen
Slide 12: Monthly virus prevalence
Monthly virus prevalence For personal use only Relative prevalence of viruses - all sites Seasonal coronaviruses dominated over the 100% winter period (Jun-Aug), but rhinovirus was 90% more prevalent in autumn and spring 80% Accords with expected seasonality of rhinovirus Adenovirus Seasonal c
Slide 13: Conclusions
Conclusions For personal use only We are achieving a good overall detection rate of 49% for respiratory viruses (45% qualifying for ITTi) Australia: 64% (59% in ITTi after SARS-CoV-2 excluded) South Africa: 36% (30% in ITTi after SARS-CoV-2 excluded) We will seek to improve the positivity ra
Slide 14: Where are we with the COVID-19 Phase 2 trial in South Africa
For personal use only Where are we with the COVID-19 Phase 2 trial in South Africa Trial started in April 2022 14
Slide 15: Phase 2 COVID-19 trial (FBP-007)
Phase 2 COVID-19 trial (FBP-007) Reduction of nasal shedding of SARS-CoV-2 in COVID-19 positive patients Primary endpoint For personal use only by the use of Nasodine® (povidone-iodine 0.5%) Nasal Spray (proof-of-concept study) = Reduction in viral load1 on Days 2-4 ITT Inclusion criteria: Recruitme
Slide 16: Trial recruitment at sites in South Africa
Trial recruitment at 3 sites in South Africa For personal use only Phase 2 COVID-19 Recruited Subjects Weak 5th wave of COVID in April-June in South 9 Africa 8 By August, we had only 15 subjects recruited 7 A shallow 6th wave appears to be emerging now 6 with recruitment growth since September
Slide 17: Pathways to approval for Nasodine
For personal use only Pathways to approval for Nasodine Potential for early approval in Australia via AAT appeal International approvals are also in the Company’s sights 17
Slide 18: The importance of approval in Australia
The importance of approval in Australia For personal use only Share of World Pharma Sales (2017) Australia is 1% of the world pharmaceutical market – why is Australia Australian approval important to FRE? 1% ROW 7% 1. It’s the home market of our investors; when Nasodine is available, we believe Au
Slide 19: Pathway to approval in Australia
Pathway to approval in Australia For personal use only Feb 2022: Initial decision by TGA delegate to not approve Nasodine, on the basis that existing clinical data did not sufficiently support the efficacy of the product [FRE strongly believes otherwise] May-Jul 2022: FRE appealed the decision u
Slide 20: Pathway to international approvals
Pathway to international approvals For personal use only Europe FRE plans to submit a MAA (Marketing Authorisation Application) in Europe by end of 2023 (regardless of AAT outcome) This will incorporate the results of the current Phase 3 trial Earliest expected approval in Europe is 2025 USA
Slide 21: International partnering
For personal use only International partnering Activities and plans for 2022/23 21
Slide 22: Nasodine's global opportunity
Nasodine’s global opportunity For personal use only The global OTC (over-the-counter) pharmaceutical Major OTC Pharmaceutical Companies market is valued at more than US$170 billion in 20221, whereas the prescription pharmaceutical market is up to 10 times this size Major reason for the differenc
Slide 23: Nasodine's strong patent position should also be attractive for licensing
Nasodine’s strong patent position should also be attractive for licensing For personal use only Nasodine has three commercially useful patents: 1. Core patent protects the use of intranasal PVP-I for the treatment or prevention of the common cold Now granted in 27 countries Covers PVP-I formul
Slide 24: Key Market Strategy
Key Market Strategy For personal use only US + EU = 60% of Nasodine’s sales potential • For prescription pharmaceuticals, the US dominates global sales due to its high drug prices (absence of centralised price controls, unlike Europe) • For OTC pharmaceuticals, pricing is similar between US and EU;
Slide 25: Licensing strategy for 2023
Licensing strategy for 2023 For personal use only FRE is seeking licensing partners for US and EU, who also have marketing capability in all other available markets (e.g., Latin America, S.E. Asia) FRE has retained US-based Pullan Consulting to act as its licensing consultant and intermediary in
Slide 26: What to expect in 2023
For personal use only What to expect in 2023 26
Slide 27: Goals for calendar year 2023
Goals for calendar year 2023 For personal use only AAT Complete the AAT process and gain approval of Nasodine then launch Nasodine in Australia in 2023 Phase 2 trial Close the COVID-19 Phase 2 trial by mid-2023 and report the results Phase 3 trial Complete the common cold Phase 3 trial by mid-2023;
Slide 28: Thank you
For personal use only Thank you Any questions?
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