Dimerix will gain early  access  to  forecast  FY23  R&D  Tax  Incentive  (RDTI),  strengthening its financial position to continue executing upon its Phase 3 FSGS kidney clinical trial.

ASX listed biotech Dimerix (ASX:DXB) has today announced that it has entered into a non-dilutive funding agreement with Radium Capital (Radium), providing early access to a part of the R&D tax incentive.

The facility provides DXB with immediate funds equivalent to 80% of its accrued R&D tax incentive for the period July 1, 2022 –  December 31, 2022  and  allows  for  a  further  advance payment upon each quarter end.

The initial advance of $2,842,500 was based on eligible R&D tax incentive expenditure that has been verified by an independent accounting firm.

The advance will be received in the next week, accruing interest at the compounded rate of 1.17% per month, and repayment is timed to coincide with receipt of DXB’s 2023 R&D refund, expected by September 30, 2023.

DXB reported a cash position of $5.7 million as of December 31, 2022.

Funding security for ACTION3 clinical trial

DXB’s Phase 3 trial is titled Angiotensin II Type 1 Receptor (AT1R) & Chemokine Receptor 2 (CCR2) Targets for Inflammatory Nephrosis – or ACTION3 for short.

It is a pivotal multi-centre, randomised, double-blind, placebo-controlled trial of the efficacy and safety of lead drug DMX-200 in patients with FSGS who are receiving a stable dose of an angiotensin II receptor blocker (ARB).

Once the ARB dose is stable, patients aged 18 to 80 years will be randomised to receive either DMX-200 (120 mg capsule twice daily) or placebo.

The trial is broadening to 12 to 80 years following first successful interim analysis. A meeting with the US FDA recently confirmed inclusion of paediatric adolescent patients aged 12 to 17 was appropriate in the current global trial, recognising its appropriate safety profile.

Large addressable market for FSGS

FSGS is a rare disease with no existing registered treatment options specifically for sufferers.

The total global FSGS market was valued at US$12.6 billion in 2022 with a CAGR of 8.2%, driven by ~220,000 FSGS sufferers across the seven major markets and premium orphan drug pricing.

DMX-200 has previously received Orphan Drug Designation with the FDA, EMA, and UK, allowing potential fast track of commercialisation if successful.

DXB CEO and managing director Dr Nina Webster has welcomed early access to the R&D tax incentive.

“This non-dilutive facility is a prudent option to strengthen our balance sheet and allows us to continue to progress towards commercialisation of our lead candidate, DMX-200,” she said.

This article was developed in collaboration with a Dimerix, 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.