Tissue Repair Limited announced that it has received responses to the matters raised in the Type C meeting that the Company submitted to the FDA on June 29, 2022. The Type C meeting sought clarity on substantive matters for the Company to prepare to progress into a phase 3 clinical program for its lead drug candidate TR-987®. In its response, the FDA has broadly accepted as reasonable the Company's intended approach to: Chemistry Manufacturing and Controls - including release specifications for Glucoprime®.

Raw material - including the Company's yeast supply arrangements, characterization and creation of a master cell bank facilitating long-term supply of this raw material. Toxicology - including the Company's proposed abridged toxicology program consisting of an in vitro degradation analysis, a 28-day mini-pig toxicology study, and a maximal clinical use human study. The Company also sought advice from the FDA on Fast Track Designation and/or Breakthrough Therapy Designation (FTD/BTD).

2B study alone, stating that for this to be considered a further phase 2 trial would be required. The FDA did however note that if the Company adopted this route, it may only have to conduct a single confirmatory (phase 3) trial, rather the two phase 3 trials it has been planning and budgeting for. The FDA indicated that if results showed that TR-987® had the potential to address an unmet medical need in the treatment of venous stasis (leg) ulcers over the existing therapies, it could then submit a formal request for FTD/BTD status.

Based on the recommendations within the Type C meeting response, the Company is pleased to have greater clarity on key matters to progress into a phase 3 program, which was the main purpose of the meeting. The Company will continue to consult with its regulatory advisers and then seek further discussions with the FDA on the outstanding matters, with a view to holding a meeting with the FDA to close out its phase 2 studies and confirm protocols for its planned phase 3 trials. At this stage, the Company still believes that it is on track to commence its phase 3 clinical trials in 2023.

The Company remains confident that the costs of the adjusted program of work required by the FDA following resolution of the outstanding items above can be fully funded from its current cash reserves to deliver a phase 3 outcome.