Can Tissue Repair Hit July Milestone as TR987 Trial Stalls and TR Pro+ Sales Shift?

Phase 3 Trial Progress and Challenges

Tissue Repair Limited (ASX, TRP) has provided a detailed update on its December 2025 quarter, highlighting a mixed picture for its lead drug candidate TR987®. The Phase 3 clinical trial aimed at treating chronic wounds has encountered slower-than-expected patient recruitment, with only around 40 patients randomised so far. The company is targeting 100 patient randomisations by July 2026 to enable an interim analysis that will determine whether the trial should continue.

This slowdown is attributed to a lack of organic patient volume and competition from numerous other clinical trials, a consequence of recent US Medicare regulatory changes requiring clinical data for reimbursement. Tissue Repair is actively replacing underperforming sites and expects larger institutions to come online in the third and fourth quarters of fiscal 2026, which should accelerate recruitment.

TR Pro+ Commercialisation Gains Traction

Meanwhile, Tissue Repair’s TR Pro+® product line, designed for aesthetic and medical wound healing, is undergoing a strategic commercial transition. Since September 2025, the company has partnered with Advanced Cosmeceuticals Pty Ltd to leverage their extensive clinic network and retail capabilities. Although sales dipped in the December quarter due to the transition, Advanced Cosmeceuticals reported over 3,000 tubes sold in November and aims for 5,000 tubes by February 2026.

A significant sales uplift is anticipated with the March 2026 launch of multiple SKUs, including new tube sizes and professional-use pump packs. This launch coincides with the first manufacturing batch of the TGA-approved TR Pro+ product. The company is also prioritising securing wholesale and retail pharmacy distribution channels over the next six months.

Regulatory and Manufacturing Developments

On the regulatory front, Tissue Repair has confirmed that the FDA will continue to classify TR987 as a drug rather than a biologic, maintaining the current regulatory pathway. The company is progressing its US 510(k) and CE mark Class I and II device submissions for TR Pro+, with biocompatibility testing underway and technical dossiers being compiled for multiple markets including the US, EU, and Southeast Asia.

Manufacturing partnerships are also evolving, with negotiations ongoing with BiomeCentric to reduce API production costs by up to 60%. Preparations for a major production campaign in March 2026 are on track, supporting the upcoming product launches and inventory needs through to March 2027.

Financial Position and Strategic Outlook

Financially, Tissue Repair ended the quarter with $8.229 million in cash, after net operating cash outflows of $2.122 million driven primarily by research and development and manufacturing costs. Revenue from TR Pro+ sales was $96,000 for the quarter, down from $298,000 previously, reflecting the distributor transition phase. The company expects revenue to rebound in the first quarter of 2026 as the new distribution network ramps up.

Importantly, the company has signalled a strategic pivot, if the Phase 3 trial does not meet the interim analysis threshold, it will terminate the trial and focus aggressively on commercialising the TR Pro product line globally. This includes ongoing regulatory submissions and expanding the product portfolio with new wound care and aesthetic formulations powered by their proprietary Glucoprime® technology.