Melbourne kidney disease drug developer Dimerix has drawn $17 million from a $34 million loan facility as its lead candidate goes through a pivotal Phase 3 trial.
Dimerix says the new funds and its existing cash will fund the ACTION3 Phase 3 trial of DMX-200 through to completion. It will also keep the Phase 2 trial of DMX-652 in acute kidney injury moving. Those forecasts depend on current plans, spending and exchange rates.
Chief executive Dr Nina Webster said the decision to draw only half the money was deliberate. "The receipt of these funds further strengthens Dimerix's financial position and supports the continued execution of our key value-driving programs, including the ACTION3 Phase 3 study of DMX-200 and the advancement of DMX-652. Importantly, we have maintained our disciplined approach to capital management by drawing only 50% of the facility at this time. This minimises financing costs while providing significant flexibility to access the remaining committed funds should they be required in the future."
The company can draw the remaining $17 million whenever it chooses until 31 March 2027. Under the facility's terms, Dimerix can also raise total commitments to $50 million before that date, but the company says it has no current plans to do so.
The funds comes as loans rather than new shares, so existing investors avoid dilution. Dr Webster described the arrangement in those terms. "The facility is an attractive non-dilutive source of capital that allows us to advance our development and commercialisation activities while preserving value for existing shareholders. We thank our shareholders and stakeholders for their continued support as we progress our strategic and operational priorities."
Dimerix expects to repay the loans through milestone payments owed by existing licensees, new licence fees, or by returning to capital markets. It has signed five commercial partners across major markets. Those partners have paid $81 million upfront so far, and a further $237 million in development milestone payments is possible before commercial launch. The company says it will keep looking for partners in territories where DMX-200 is not yet licensed.
DMX-200 is being tested in people with focal segmental glomerulosclerosis, or FSGS. In this rare and serious disease, scarring of the kidney's filtering units can lead to kidney failure, dialysis or transplantation. The ACTION3 trial is fully recruited. More than 40,000 people in the United States are estimated to live with FSGS, and no therapy is specifically approved for it there. In patients whose disease is progressive or resistant to treatment, the average time from diagnosis to end-stage kidney disease can be as short as five years. The disease also returns in up to 60 per cent of people who receive a transplant.
The drug blocks the CCR2 chemokine receptor. It is given to patients who already take an angiotensin II receptor blocker, the standard treatment for hypertension and kidney disease. DMX-200 has orphan drug designation in the United States, Europe, the United Kingdom and Japan. Its granted patents run to 2032, and pending applications could extend protection to 2042.
Dimerix recently acquired its second program, DMX-652. It targets acute kidney injury after cardiac surgery, a condition in which kidney function falls within hours and for which no treatment is approved. Dimerix estimates that about 260,000 patients a year are affected across the United States, Germany, France, Italy, Spain and the United Kingdom. The drug is an oral capsule taken once a day. It inhibits USP30, a mitochondrial enzyme, and is designed to help injured kidney cells clear damaged mitochondria. The US Food and Drug Administration has approved the Phase 2 protocol.
