TrivarX secures $2.5m funding for clinical trials and FDA approval

TrivarX Limited (ASX: $TRI) has secured firm commitments to raise $2.5m through the issue of 100m new fully paid ordinary shares. The funding will be utilized for the completion of TrivarX's Phase 2 Sleep Signal Analysis for Current Major Depressive Episode (SAMDE) study using MEB-001, the company's proprietary algorithm for effective screening of a current Major Depressive Episode (cMDE). Additionally, the capital will be deployed towards obtaining United States (US) Food and Drug Administration (FDA) approval for MEB-001.

Executive Commentary on Funding and Regulatory Approval

Non-executive Chairman, David Trimboli, expressed, 'We are pleased to announce this strategic share placement, which will provide the Company with the required balance sheet strength to capitalize on the recent momentum of our comprehensive clinical trial program for TrivarX's proprietary MEB-001 algorithm. As the Company's Phase 2 SAMDE Study advances towards completion, these funds will support ongoing engagement with US regulators following a positive meeting with the FDA in February where TrivarX established a clear pathway to regulatory approval for MEB-001. Following the diligent execution of our Phase 1 and Phase 2 clinical studies, the June quarter now represents a particularly exciting time for the Company in pursuit of its objective to establish a clinically-backed solution for the improved diagnosis of current Major Depressive Episode. In that context, the placement attracted strong interest and we would like to thank our investors for their ongoing support of our pathway to FDA approval.'

Summary of TrivarX's Funding and Regulatory Approval Initiatives

TrivarX Limited (ASX: $TRI) has successfully secured firm commitments to raise $2.5m for the completion of its Phase 2 Sleep Signal Analysis for Current Major Depressive Episode (SAMDE) study and obtaining United States (US) Food and Drug Administration (FDA) approval for its proprietary MEB-001 algorithm. The company's Phase 2 SAMDE study is progressing well with 307 patients enrolled, and the completion and results are expected to materialize this quarter. TrivarX aims to utilize any positive data from the study to further validate its proprietary algorithm before engaging with the US FDA. The placement, strongly supported by new and existing domestic and international investors, will be conducted in two tranches. The first tranche of 70,970,745 Shares will be issued under the Placement, representing approximately 20.97% of current shares on issue. The second tranche, subject to shareholder approval, will issue 29,029,255 fully paid ordinary shares. The issue price of new Shares represents a 0.79% discount to the 15-day Volume Weighted Average Price. The company's management is optimistic about the upcoming period, aiming to establish a clinically-backed solution for the improved diagnosis of current Major Depressive Episode and expressing gratitude for the investors' support in the pathway to FDA approval.