DXB - Dimeriz Limited

more pump

DIMERIX (ASX: DXB) - JOEL FLEMING - YARRA CAPITAL MANAGEMENT​

Dimerix 1-year chart (Source: Market Index)

What is the company and what is it doing?​

Dimerix is a biotech company with a market cap of $230 million, currently conducting a Phase 3 clinical trial for a treatment targeting focal segmental glomerulosclerosis (FSGS), a rare kidney disease that attacks the kidney’s filtering units, leading to irreversible damage and eventual kidney failure. With no approved treatments available, the company has secured orphan drug designation from both the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA), supporting the development of therapies for rare diseases.

How could it change people's lives?​

Successful drug development can be life-changing for those suffering from a disease, particularly when no other treatment options are available.

It is meaningful not only for patients but also in helping to reduce the burden on the global healthcare system. Success in rare diseases can also pave the way for further scientific breakthroughs and deeper understanding.

Why do you like it?​

I like it because there is a clear unmet need for this health problem. Success will open a clear commercial opportunity which will drive significant value growth for the business.

I also like the near- and medium-term news flow around FDA updates, potential licensing deals and the longer-term trial results.

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What needs to happen for it to go to the next level?​

For this to reach the next level, several factors must align, the most important being that the drug is proven safe and effective through the current clinical trial and accepted by the FDA.

We also see near-term positive catalysts before reaching this decision point. Recent discussions with the FDA will either confirm the status quo of the current trial or introduce the potential for modified endpoints and accelerated approval.

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The company has signed three licensing deals to date, but large market opportunities in the US and China remain unlicensed. Securing agreements in these regions represents a significant opportunity for the business and would further validate its potential. Positive changes to trial endpoints and additional licensing deals are likely to be well received by investors.

What are the risks to the thesis?​

Dimerix is fast approaching a pivotal decision point, where failure to meet its primary endpoint could result in significant value destruction. We remain optimistic based on the promising data observed so far. Our investment process is based on carefully balancing potential upside with substantial risks while adjusting our position size to manage exposure accordingly.

"DIMERIX has filled the US gap in its network of global partnerships, today revealing a US tie-up potentially worth more than A$1 billion if the company’s kidney drug candidate is commercialised there.

Dimerix chief Dr Nina Webster dubs the compact, with the Nasdaq-listed rare diseases house Amicus Therapeutics, as “one of the biggest deals in Australian biotech history”.

Under the deal, Dimerix delivers to Amicus exclusive US rights to its drug candidate DMX-200, which is intended to treat the rare regressive fibrotic kidney disease focal segmental glomerulosclerosis (FSGS).

Amicus also has dibs on any further indications.

Amicus pays an upfront US$30 million ($48 million) to Dimerix, with the potential for up to US$520 million of success-based payments.

These consist of US$410 million of sales milestones, US$75 million on regulatory approval and US$35 million on first sales.

Dimerix is also entitled to tiered royalties on sales, in the “low tens to low twenties” range.

Except in Japan, Dimerix remains on the hook for the cost of the placebo-controlled trial, which is enrolling 286 patients across multiple sites.

‘Ideal partner’

Webster said Dimerix was “absolutely thrilled” to be partnering with the US$2.2 billion market cap Amicus, which has two commercialised rare disease products and extensive regulatory expertise.

“This makes Amicus the ideal commercial partner for Dimerix,” she says.

“Collectively this puts us in a far stronger position to bring our exciting drug candidate to patients with limited treatment options.”

The Amicus tie-up follows three earlier licensing deals. The four deals combined are worth a ‘headline’ potential $1.4 billion (excluding royalties) and have delivered $66 million in upfront payments.

Unveiled in October 2023, Dimerix signed the Europe, Canada, Australia and New Zealand rights to Advanz Pharma.

This deal delivered $10.8 million upfront and potential milestones of $219 million.

In May last year the company struck a deal for Iraq and the Gulf Countries.

This delivered $10.8 million upfront and another $120 million of potential milestones.

In January this year, Dimerix struck a deal with Japanese company Fuso which delivered another $7.2 million upfront and $100 million of potential milestones.

All eyes on phase III trial progress
Of course, most of the funding is back-ended and depends on trial success and US Food & Drug Administration (FDA) approval.

Following the failure of Opthea’s (ASX:OPT) two phase III eye programs, investors won’t be taking anything for granted.

But Dimerix has the benefit of an unblinded interim readout, which showed efficacy on key primary endpoints that were better than the placebo control.

“Dimerix has good validation for the asset, both technically and commercially,” Webster says.

“We have already demonstrated a strong safety profile and we have already collected encouraging efficacy data, across both the [earlier] phase II trial and the first unblinded clinical analysis for the phase III trial.”

Helpfully, the FDA has agreed to the use of a so-called surrogate endpoints – the level of a certain protein in the urine – in the trial.

With no other dedicated FSGS treatment available, the FDA has accorded DMX-200 ‘orphan’ drug designation.

This confers benefits such as higher pricing and an exclusive marketing period.

Similar orphan drugs in the US sell for between US$120,000 and US$500,000 for a year’s treatment.

In the meantime, Dimerix continues to pursue licensing deals in key remaining geographies including mainland China and Latin America.

Dimerix shares soared close to 50% after a trading halt was lifted.

Petra Capital analyst Tanushree Jain says the better-than-expected deal “provides tangible evidence of industry interest in the DMX-200 asset and the continued exemplary execution capabilities of Dimerix management.”

Stonkhead

With the upheaval market condition and from my simplest systems; indeed this is one of my delicacy.....daaa yum!
again this is me and not recommending anything here cheers!

Have a good night everyone

TLWE



MTLE

flesh

Dimerix (ASX : DXB) rocketed 65.2% since Thursday 24 April to close at 76 cents on Friday, following a major licensing agreement with US-based Amicus Therapeutics. The deal grants Amicus exclusive rights to commercialise Dimerix’s kidney drug DMX-200 for FSGS—a rare and serious kidney condition—in the United States. In return, Dimerix receives a US$30 million upfront payment, with the potential for up to US$560 million in success-based milestone payments and tiered royalties. DMX-200 is currently in a Phase 3 trial, with FDA agreement on its approval pathway already secured. The deal validates Dimerix’s scientific platform and gives it non-dilutive funding to advance its pipeline outside the US.