Dimerix secures firm commitments for a $20m institutional placement
\n\u2018Highly strategic\u2019 capital raise will see new institutional investors join the company\u2019s register
\nProceeds will be used to advance the ACTION3 Phase 3 trial of DMX-200 in FSGS patients<\/p>\n
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Special Report:<\/em><\/strong> Dimerix has announced a capital raise of $20 million just one day after releasing positive long-awaited interim analysis of its ACTION3 Phase 3 trial of DMX-200 in patients with focal segmental glomerulosclerosis (FSGS).\u00a0 <\/strong>\u00a0<\/strong><\/p>\n Biotech Dimerix (ASX:DXB)<\/strong><\/a>\u00a0<\/strong>emerged from a trading halt to announce it had received binding commitments from new and existing institutional and sophisticated investors (and other exempt investors) to raise $20 million.<\/p>\n The share placement is for 66,666,667 fully paid ordinary shares at an issue price of 30c per placement share.<\/p>\n DXB says the issue price reflects no discount to the company\u2019s recently traded price, reflecting a 29.2% premium to the 30-day VWAP of 23.2c\/share, a 14.5% premium to the 5-day VWAP of 26.2c\/share, and a 52-week share price high.<\/p>\n Euroz Hartleys served as the sole lead manager for the placement, with shares expected to be issued on or around March 20, 2024.<\/p>\n \u00a0<\/p>\n DXB on Monday announced its ACTION3 Phase 3 trial was successful<\/a> in the pre-specified interim analysis of proteinuria (efficacy) endpoint from the first 72 randomised patients.<\/p>\n Titled Angiotensin II Type 1 Receptor (AT1R) & Chemokine Receptor 2 (CCR2) targets for Inflammatory Nephrosis, or ACTION3 for short DXB\u2019s Phase 3 trial is a multi-centre, randomised, double-blind, placebo-controlled study.<\/p>\n The interim analysis showed DMX-200 is currently performing better than the placebo in reducing proteinuria (using a statistical measure) in patients with FSGS in a significantly larger cohort than its prior Phase 2 trial of eight patients.<\/p>\n DXB says passing the early interim analysis suggests a statistically significant and clinically meaningful result in reducing proteinuria at the end of the study may be possible.<\/p>\n The trial\u2019s Independent Data Monitoring Committee (IDMC) also says it has no safety concerns relating to DMX-200, adding to the drug\u2019s growing safety profile \u2013 and formally recommended the trial continue as planned.<\/p>\n The ACTION3 Phase 3 clinical trial will now formally expand into Part two, with new clinical sites to open in additional countries, including China, to further enhance recruitment.<\/p>\n The full trial is expected to enrol ~286 patients, with a second interim analysis planned after the first 144 patients complete ~35 weeks of treatment.<\/p>\n \u00a0<\/p>\n DXB has garnered significant interest from global pharmaceutical companies with an initial licensing agreement with Advanz Pharma in October 2023 for Europe, Canada, Australia and New Zealand.<\/p>\n The deal, valued at up to $230 million plus royalties, is the first among several non-binding term sheets received for other regional agreements.<\/p>\n DXB says multiple parties are actively engaged in due diligence and negotiations, and is exploring potential licensing agreements for various territories.<\/p>\n With the successful completion of the first interim analysis, DXB is now directing its focus towards executing potential licensing deals, particularly in the US and China, among other available jurisdictions.<\/p>\n \u00a0<\/p>\n DXB says the $20 million (before costs) raised under the placement will be used advancing the ACTION3 Phase 3 clinical trial in patients with FSGS.<\/p>\n Funds will be used for preparation and submission of appropriate regulatory applications as and when applicable to continue the FSGS Phase 3 clinical study.<\/p>\n DXB says money raised will also be used for manufacturing distribution and logistics of the required clinical trial material, transaction\/partnering activities, working capital and offer costs.<\/p>\n \u00a0<\/p>\n DXB managing director and CEO Dr Nina Webster welcomed the company\u2019s new institutional and sophisticated investors, while acknowledging the strong support from existing shareholders.<\/p>\n \u201cThis placement was highly strategic as it provides sufficient funds to take Dimerix through the second interim analysis and, including eligible R&D rebates, the completion of the ACTION3 Phase 3 clinical trial,\u201d she says.<\/p>\n \u201cIf the next interim analysis is compelling, the company could seek to apply for accelerated marketing approval in certain jurisdictions.<\/p>\n \u201cBy completing this placement, Dimerix has not only accessed funding from high quality institutional investors to deliver on its Phase 3 program, but also significantly strengthened its balance sheet.<\/p>\n \u201cThis puts us in a strong negotiating position with potential partners, particularly on the back of our successful interim analysis just announced.\u201d<\/p>\n \u00a0<\/p>\n This article was developed in collaboration with Dimerix, a Stockhead advertiser at the time of publishing. <\/em>\u00a0<\/em><\/p>\n This article does not constitute financial product advice. You should consider obtaining independent advice before making any financial decisions.<\/em><\/p>\n <\/span><\/p>\n The post Dimerix completes \u2018highly strategic\u2019 $20m cap raise to advance ACTION3 Phase 3 trial<\/a> appeared first on Stockhead<\/a>.<\/p>","protected":false},"excerpt":{"rendered":"ACTION3 interim analysis meets endpoint<\/strong><\/h2>\n
Strong partner interest <\/strong>\u00a0<\/strong><\/h2>\n
Funds to advance ACTION3 trial <\/strong><\/h2>\n
\u2018Highly strategic\u2019 placement<\/strong><\/h2>\n