Tissue Repair Ltd · ASX:TRP
Tissue Repair — Corporate Update (September 2023)
26 slides from Tissue Repair's corporate update, Sep 18, 2023
Slide 1: Tissue Repair Limited Company Update
For personal use only Tissue Repair Limited Company Update • Progress on TR987® Phase 3 trials • Sales commence for TR Pro+TM September 2023
Slide 2: Key Updates since IPO
TR987- Cleared to enter Phase 3 by the FDA. A core Clinical Operations capability has been established with first patient randomisation planned for early Q2 2024 Key Updates since IPO Glucoprime® - Patented platform technology. Applicable to many types of • wound healing in humans and animals. use o
Slide 3: TR is achieving key milestones within its existing funding envelope
Despite some delays TR is achieving key milestones . . . within its existing funding envelope TR987® TR Pro+TM Phase 3 trial approval Product launch in May 2023 Intellectual Property Funding For personal use only received by FDA ✓ ✓ ✓ ✓ ✓ ✓ ✓ ✓ ✓ ✓ ✓ ✓ ✓ ✓ ✓ ✓ ✓ ✓ ✓
Slide 4: Glucoprime technology platform applicable for multiple types of wounds
TRs technology platform Glucoprime ® is applicable for multiple types of wounds in humans and animals Receptors on macrophages within damaged tissue recognize the Glucoprime® - containing hydrogel. Macrophages are the ‘guard’ cells that protect against invaders. For personal use only Two receptors,
Slide 5: Medium term focus on commercialisation of two products
The medium term focus is on commercialisation of two products for two discrete applications, each having significant markets and compelling economics . . . success in either is a significant value milestone An FDA-approved label for the treatment Horizon 2 For personal use only of chronic wounds is
Slide 6: TR987 Chronic Wounds
For personal use only TR987® CHRONIC WOUNDS
Slide 7: Meta-analysis confirms 60% reduction in wound size vs placebo
NEW DATA A recent meta-analysis on 147 patients from two Phase 2 trials has confirmed a strong signal of efficacy and demonstrated a 60% reduction in wound size vs placebo control (p=0.03). A strong data point, providing further confidence on a successful Phase 3 outcome For personal use only In Mar
Slide 8: Phase 2B Refresh: per protocol cohort 20% delta over placebo
Phase 2B Refresh . . . The Per Protocol cohort in the phase 2B study demonstrated a 20% delta over Standard of Care combined with placebo on a range of metrics. The aim is to replicate this significant clinical effect in a larger patient cohort in a Phase 3 trial For personal use only Most clinician
Slide 9: Efficacy signal on percent wound area reduction in Phase 2B
Efficacy signal on percent wound area reduction over the treatment period in Phase 2B study. The per protocol population demonstrated a clear weekly projection towards healing over placebo+SOC For personal use only The PP set included all patients which adhered to the protocol and competed the 12 we
Slide 10: Example of a closed venous leg ulcer following TR987 treatment
An example of a closed venous leg ulcer following treatment by TR987 ® during the Phase 2B trial For personal use only
Slide 11: TR987 for chronic wounds - key advantages over current products
TR987® for chronic wounds - key advantages over current products • No drug or biologic appears to have been approved in chronic wounds since REGRANEX gel in 1997, and as Strong efficacy such a drug label with high quality clinical data drives reimbursement and is highly prized For personal use only
Slide 12: TR Pro+ (Aesthetic and Minor Medical Procedures)
For personal use only TR Pro+TM (AESTHETIC AND MINOR MEDICAL PROCEDURES)
Slide 13: Phase 2B laser resurfacing study showed improvement in skin quality
The Phase 2B study using laser skin resurfacing showed a statistically significant improvement in skin quality at Day 28 Wrinkling Elastosis In this group, 85% of responders in the active In this group, 75% of responders in the active group achieved a wrinkling score improvement group achieved an el
Slide 14: Phase 2B study published in peer reviewed journal
The Phase 2B study was recently published in a peer reviewed journal (Wu et al. 2022) For personal use only Study Author's concluded “In summary, this study demonstrates the potential of TR Pro+TM 0.1% gel to significantly improve skin quality outcomes after fractionated ablative laser resurfacing w
Slide 15: Example of redness and irritation following TR Pro+ treatment
A typical example of redness and irritation following treatment by TR Pro+ TM in the Phase 2B laser skin resurfacing study Close to double the For personal use only improvement in skin quality as measured by elastosis and wrinkling Days post- vs standard of care & placebo procedure Day 1 Day 28
Slide 16: Real-world evidence study: patients rated TR Pro+ good or better
In a real-world evidence study (2022), 100% of patients rated TR Pro+TM as good or better than previous post-procedure aftercare product used. . . 85% of patients rated it as 4/5 stars on healing and skin quality For personal use only Patient responses at days 6 and 28 Similar or better compared to
Slide 17: TR Pro+ opportunity to deliver on an unmet need
TR Pro+ TM - an opportunity to deliver on an unmet need in current therapy following aesthetic and minor medical procedures For personal use only • • • • • • • • • • •
Slide 18: Post procedure topical market has no clear product lead
The post procedure topical market has no clear product lead, and is potentially a USD1b* market globally Skincare and cosmetics are significant global markets with strong CAGRs • Total revenues from the global cosmetics market are set to hit $103.8 billion in 2023 • Skincare was the leading category
Slide 19: Intellectual Property
Intellectual Property Glucoprime® meets the FDA criteria of A New Chemical Entity (NCE). There is no drug substance currently approved globally for any indication based on Tissue Repair’s engineered molecule. This provides the potential for exclusivity preventing competitors from replicating the tec
Slide 20: Strategy on a Page
Tissue Repair. Strategy on a Page Stage of clinical development Market Product Strategy Commercial Preclinical Ph 1 Ph 2A Ph 2B Ph 3 • Achieve FDA and TGA For personal use only 2024 approval as a topical Progression to commence #1 Chronic drug for use in venous Ph3 following partnering TR987® leg ul
Slide 21: Capital Structure Update
Capital Structure Update All seed and founders escrowed for up to 3 years to align with Phase 3 readout For personal use only Shares on Issue 60,464,843 Options on issue 22,270,580 $ 0.49 (Average exercise price) Cash as at 31 March 2023 $21.8m All options issued pre IPO, did not dilute IPO sharehol
Slide 22: Appendix: Additional clinical data - Phase 2B Trial
For personal use only Appendix Additional clinical data - Phase 2B Trial
Slide 23: Phase 2B ITT Summary Results
Phase 2B ITT Summary Results. Partial and complete healing metrics. For personal use only
Slide 24: Phase 2B Per Protocol Summary Results
Phase 2B Per Protocol Summary Results. Partial and complete healing metrics. For personal use only
Slide 25: For personal use only
For personal use only
Slide 26: Important notice and disclaimer
For personal use only Important notice and disclaimer