DXB - # Next NEUREN ?

Forum Topics DXB DXB # Next NEUREN ?

Pinned straw:

Added 12 months ago

First time straw poster - so please go easy :-)

Was fortunate to catch the NEU train IRL prior to FDA approval (still hold and waiting patiently for Dec NNZ-2591 PH2 read-out), plus have tactical % allocations to other ASX listed biopharma such as IMM, IMU, PAR and TLX.

One have also added recently is DXB (Dimerix).

Their lead candidate drug is DMX-200 currently in PH 3 development - that treats FSGS (Focal Segmental Glomerulosclerosis), being a rare disease that causes kidney scarring and can lead to end-stage kidney disease.

DMX-200 has been granted Orphan drug status by FDA and EMA - with FSGS market size est. at US$3B across the 7 major markets the company is targeting.

They have other drugs such as DMX-700, to treat Chronic Obstructive Pulmonary Disease (COPD). But have stated that DMX-200 is their main focus currently in bringing to market.

The companies strategy is to partner with specialist rare disease Pharma Companies to bring their drugs to market, and recently signed a DMX-200 licensing agreement with ADVANZ Pharma for territories Europe, UK, Canada, Australia, New Zealand.

DXB retains rights to all remaining territories (inc. US) and are currently working on finding additional partners.

Other than strategy and commercial similarities to NEU - What strikes me as interesting is that ADVANZ have agreed to a licensing deal, with upfront payment, sales milestone payments and tiered royalties - prior to FDA approval and prior to an important Phase 3 read-out upcoming ~Mar 15th 2024.

Sep Quarter 4C report, DXB had $6.8 M is cash, and subsequently just received the up-front payment from ADVANZ of A$10.7 M.

Even after this up-front payment, it remains un-clear whether they have enough cash to get DMX-200 to registration stage.

Should additional partnering deals be struck across the next two Quarters, with similar up-front components as with ADVANZ, then likely they will have the required cash to make registration.

Therefore the Mar 15th result read-outs are very pivotal.

DXB has a market cap of ~$60 M so still very much a micro-cap and highly speculative.

Disc: Held IRL and SM

conrad

Added 8 months ago

Presentation by Dr Nina Webster around FSGS and DMX-200.

She touches on Phase III trial progress, potential market size & pricing, plus the benefits of orphan drug designation (possibility for accelerated approval in some markets based on second interim analysis outcomes).

Also touched on the Advanz Pharma partnership and what they are looking for in partners for other regions.

https://youtu.be/diDMtiYZYCA?si=dfGmz0HEL3Lr6cpP

Might be a bit light on detail for those fully across this business but a good introduction for newbies like me.

Dr Webster didn’t go as far a calling DXB the next Neuren, but there was an NEU price chart in her presentation ;)

edgescape

Added 8 months ago

So from the ASX small cap presso, 97 patients recruited as of 6 Apr which is an extra 20

If Part 2 recruitment began after 11 mar and we are now 6th April then 25 days have been used to recruit 20 patients.

So that is an average of 20/25 or 0.8 patients per day.

To get to 144 patients then we need to wait another 58.75 days.

Therefore Part 2 could begin around mid July 2024.

In addition there is the main hurdle that patients MUST be on the max dose of Irbersartan (300mg). That is quite a high dose and could cause really low blood pressure which is what you don't want.

Again no mention of Rituximab which although not an approved treatment, it is still something every Renal doctor uses perhaps due to the affordability. Therefore I see DMX-200 as a Ferrari compared to Rituximab so I don't think you can compare DMX-200 to Neuren's Daybue. In addition Sparsentan could be first to market if FDA.is happy with the new clinical data in which case Sparsentan would be the equiv of Daybue, not DMX-200..

Having said that, CSL partner, Travere, is also guilty of not mentioning Rituximab when talking about Sparsentan.

Although I'm a holder of Dimerix, I have now a high level of skepticism with these drugs since I've got some first hand knowledge from the front line.

In summary,

* Part 2 trial will take some time before it starts and not all patients will get a go if they can't take the higher ARB dose.

* Still no mention of how they position themselves against or even acknowledge the adjunct treatment (or is it off-label use??) of Rituximab.

Please understand I'm just setting expectations as a holder for Dimerix in contrast to the videos from Nina Webster. Then again, this is part and parcel of small cap land. In hindsight I should have sold when it hit 36c but what prevented me from selling is that I've held less than a year and I came before I started talking to some of the Renal and liver doctors recently.

Metis

Added 10 months ago

My understanding of where the company is at according to recent studies.

Phase 2 (for diabetic kidney disease): https://investors.dimerix.com/DownloadFile.axd?file=/Report/ComNews/20200914/02280306.pdf

45 patients with diabetic chronic kidney disease: no statistically significant difference for the full cohort. However it was seen as statistically significant in those with higher levels of proteinuria (using 24 hour measurement which is gold standard). Simplistically this is an anti-inflammatory of the kidneys so in my mind makes sense the worse the proteinuria the greater percentage improvement.

Phase 2a (for focal segmental glomerular nephrosis) no current treatment and the what the current phase 3 study and Advanz deal is run off: https://investors.dimerix.com/DownloadFile.axd?file=/Report/ComNews/20200729/02259666.pdf

7 patient randomised control trial for focal segmental glomerular nephrosis which showed a statistically significant reduction in proteinuria. 6/7 got a >29 % reduction and 2/7 got a >40% reduction.

Phase 3: https://classic.clinicaltrials.gov/ct2/show/NCT05183646

The primary outcomes to be measured and reported in 3 parts are: (reference above)

Evaluate the efficacy of DMX-200 in terms of urine PCR in patients with FSGS who are receiving an ARB. [ Time Frame: Baseline to Week 35 ] Percent change in urine PCR (based on 24-hour urine collection)
Evaluate the efficacy of DMX-200 in terms of eGFR slope in patients with FSGS who are receiving an ARB (Analysis at week 35 and Week 104). [ Time Frame: Baseline to Week 104 ] Slope of eGFR
OLE - Assess the long-term safety and tolerability of open-label treatment with DMX-200 in patients with FSGS who are receiving an ARB. [ Time Frame: Double-blind baseline to Week 216 ]Incidence and severity of treatment-related AEs and any AESIs and SAEs following long-term treatment with DMX-200

Thoughts:

I’d be willing to bet on the first part of phase 3 trial due in March being a positive. This is based on 6/7 patients with FSGS in the phase 2a trial having a reduction in proteinuria. (I think this was only 9 patients) I would not be willing to bet yet that eGFR would improve based around this surrogate measure (proteinuria) at this stage. So for me jury is still out on that. I’ll need to have a deeper dive before I feel like I can stomach the risk/reward of holding through the 2nd part of the primary outcome. This will depend however on how the US reacts…
US may be able to take it to market just on proteinuria alone. Whereas other countries may be slightly more strict wanting eGFR. (Keep in mind though that high proteinuria is a prognostic factor for worsening disease in FSGS). The Advanz deal is just for Europe, Canada, Australia and New Zealand. Dimerix retains all other rights so a US deal may be on the cards post March.
Who knows what the other 132 million pounds in milestones are… I would say if the next bit is positive there will be a small upgrade.

I am going to buy in at some stage, The question for me is where is the market cap where a positive result is priced in?? Who knows. I see the 26 cents as hype and it’s slowly coming back down now before a little rally prior or after March. Who knows what its base will be but dare say it will be treading water until march unless they look at a deal with he US prior. I’ll likely play it for the short term until after march and reassess then.

Strawman

Added 12 months ago

Good on you for taking the plunge @MarkB -- a great first post!

mikebrisy

Added 12 months ago

@MarkB I echo @Strawman's comment.

Your report is great. I don't have the time to screen all the healthcare and biotech firms on the ASX and it is reports like this that help me prioritise my own research. (Other StrawPeople's work on $NEU and $BOT got me started on both and I hold both now.) So $DXB is on my research list now!

edgescape

Added 12 months ago

Forgot to mention this has been covered by NextInvestors (S3 Consortium)

So assume there is a bit of overhang around 20c from nextinvestor subscribers waiting for an exit

Will require some patience.

https://nextinvestors.com/company/asx-dxb/

[held]

Slew

Added 12 months ago

Bioshares also started covering DXB mid last year with a v speccy buy.

I was thinking the recent price/volume increase was the impact of the licensing deal, but shareholders bailing makes sense too, @edgescape The change in liquidity since the Advanz announcement is significant.

Pre announcement 5-20k value per day
Post announcement .5-1m value per day
volume was 5-6m immediately post announcement

Not held, but I have been loosely watching it, waiting on drug approvals. After the Advanz deal I put it on list to investigate further, I just don’t have the time at the moment.

CanadianAussie

Added 12 months ago

Nextinvestors being involved is a red flag for me. I'd rather management focus on the business rather than paying groups like S3 to promote the stock.

edgescape

Added 12 months ago

@CanadianAussie Well spotted

They are paid shares in return for marketing services. Looks like they just got out of DXB on the latest news regarding the Advanz payment.

Though the list is smaller than I expected.

edgescape

Added 11 months ago

Any idea of what is driving the DXB share price?

Up to 26c today on no news. That despite the link with S3 consortium (or perhaps past link now they are sold out).

Don't hold in SM but hold IRL. Would have been good to sell on SM for extra cash. Tempted to take profit.

acarbone1

Added 11 months ago

I hold Dimerix in RL but not on SM.

I can’t speak to the science of the product and I’m a novice at valuing unprofitable pharmaceutical companies, but I’d say the share price movement could be because they are only 2 Months away from the results release of Part One of their Phase 3 drug Trials. This coupled with a commercial deal with Advanz Pharma that rhymes with Neuren’s Arcadia deal.

edgescape

Added 11 months ago

15th of March but I think it's a bit premature to start holding / ramping the share price.

There are development milestone payments from ADVANZ, but no detail on the triggers. I doubt Part One will trigger any payment.

Didn't find any change in significant holding from IQ Pro.

Dimerix Limited