• Phase 3 trial for TR987® for chronic wounds slowed due to lack of organic patient volume, targeting 100 patient randomizations by July 2026
• TR Pro+® aesthetic and medical product commercialization progressing, with 3,000 tubes sold in November and targeting 5,000 by February 2026
• Regulatory progress on 510(k) and CE mark for TR Pro+®, with TGA-approved product expected in March 2026

Tissue Repair Ltd (ASX:TRP) has provided an update on its key operational activities and financial results for the December 2025 quarter. The company's focus remains on the Phase 3 clinical trial for its lead drug candidate TR987® for the treatment of chronic wounds, as well as the commercialization of its TR Pro+® product for aesthetic and medical procedures. The Phase 3 trial for TR987® has experienced a slowdown in patient randomizations, with around 40 patients randomized to date. The company is targeting 100 patient randomizations by June-July 2026 to trigger an interim analysis. To achieve this, the company is focused on expanding the number of active trial sites to 30. For TR Pro+®, the partnership with Advanced Cosmeceuticals Pty Ltd commenced in September 2025, with the transition of existing Tissue Repair clinics. The product has seen strong initial sales, with over 3,000 tubes sold in November 2025, and the company is targeting 5,000 tube sales by February 2026. The company expects a significant uplift in sales when all SKUs are available in March 2026, with the first TGA-approved production batch.The company is also progressing regulatory work for TR Pro+®, with 510(k) and CE mark submissions on track for the chronic wound and dermatology indications. The FDA has confirmed the product will remain classified as a drug.Financially, the company reported a cash position of $8.229 million as of 31 December 2025, with net operating cash outflows of $2.122 million during the quarter, primarily due to R&D and product manufacturing costs.

The company's core near-term focus is on achieving the 100 patient randomization target for the TR987® Phase 3 trial by June-July 2026 to trigger an interim analysis. If the interim analysis is not successful, the company will terminate the Phase 3 trial and focus on commercializing the TR Pro+ product line, including progressing regulatory approvals and global distribution.