Dimerix has raised $20 million to progress its ACTION3 Phase 3 trial of DMX-200. Pic via Getty Images.
Health & Biotech
Special Report: 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).
Biotech Dimerix (ASX:DXB) 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.
The share placement is for 66,666,667 fully paid ordinary shares at an issue price of 30c per placement share.
DXB says the issue price reflects no discount to the company’s 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.
Euroz Hartleys served as the sole lead manager for the placement, with shares expected to be issued on or around March 20, 2024.
DXB on Monday announced its ACTION3 Phase 3 trial was successful in the pre-specified interim analysis of proteinuria (efficacy) endpoint from the first 72 randomised patients.
Titled Angiotensin II Type 1 Receptor (AT1R) & Chemokine Receptor 2 (CCR2) targets for Inflammatory Nephrosis, or ACTION3 for short DXB’s Phase 3 trial is a multi-centre, randomised, double-blind, placebo-controlled study.
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.
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.
The trial’s Independent Data Monitoring Committee (IDMC) also says it has no safety concerns relating to DMX-200, adding to the drug’s growing safety profile – and formally recommended the trial continue as planned.
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.
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.
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.
The deal, valued at up to $230 million plus royalties, is the first among several non-binding term sheets received for other regional agreements.
DXB says multiple parties are actively engaged in due diligence and negotiations, and is exploring potential licensing agreements for various territories.
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.
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.
Funds will be used for preparation and submission of appropriate regulatory applications as and when applicable to continue the FSGS Phase 3 clinical study.
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.
DXB managing director and CEO Dr Nina Webster welcomed the company’s new institutional and sophisticated investors, while acknowledging the strong support from existing shareholders.
“This 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,” she says.
“If the next interim analysis is compelling, the company could seek to apply for accelerated marketing approval in certain jurisdictions.
“By 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.
“This puts us in a strong negotiating position with potential partners, particularly on the back of our successful interim analysis just announced.”
This article was developed in collaboration with Dimerix, a Stockhead advertiser at the time of publishing.
This article does not constitute financial product advice. You should consider obtaining independent advice before making any financial decisions.
Health & Biotech
Health & Biotech
Health & Biotech
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