Quarterly Activities/Appendix 4C Cash Flow Report

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Stock Tissue Repair Ltd (TRP.ASX)
Release Time 29 Oct 2025, 1:10 p.m.
Price Sensitive Yes
 Tissue Repair Ltd Quarterly Activities/Appendix 4C Cash Flow Report
Key Points
  • Forty-six clinical sites selected for Phase 3 trials, with 33 initiated and 24 activated
  • Around 35 patients randomized across the two trials
  • Progress on 510(k) submission and CE mark for TR Pro+ product
  • Partnership with Advanced Cosmeceuticals to drive TR Pro+ sales growth
Full Summary

Tissue Repair Ltd (ASX:TRP) provided an update on its key activities and cash flow for the September 2025 quarter. The company's lead drug candidate TR987 for chronic wounds is progressing through Phase 3 trials, with 46 clinical sites selected and 33 initiated, leading to around 35 patients randomized to date. The company is prioritizing completion of the US trial (BG002) while the Australian trial (BG003) continues. Progress is also being made on the 510(k) submission and CE mark for the TR Pro+ product, which will support market entry in the US and Europe for chronic wound and dermatology indications. Regulatory updates include the FDA confirming TR Pro+ will remain classified as a drug, and preparations underway for Medsafe submission in New Zealand. In the aesthetic market, the company's partnership with Advanced Cosmeceuticals commenced, transitioning existing TR clinics and providing access to over 2,500 clinics to drive TR Pro+ sales growth. The company also outlined plans for a major TR Pro+ production campaign in February 2026 and development of new products like TR-med and TR-S to expand its portfolio. Financially, the company had $10.3 million in cash at the end of the quarter, with net operating cash outflows of $1.97 million primarily due to R&D expenditure.

Guidance

The company expects meaningful sales growth for TR Pro+ through the Advanced Cosmeceuticals network from February/March 2026 when all SKUs are available, and a major production campaign is planned for that period.

Outlook

The company is prioritizing completion of the BG002 Phase 3 trial in the US, progressing regulatory approvals for TR Pro+ in the US and Europe, and developing an expanded product portfolio including TR-med and TR-S. It is also exploring commercialization strategies for TR-med and continuing to identify distribution partners for overseas markets.