DXB Progress Tracker
Treatment 1 - (Main “Bet”) - FSGS
Treatment 2 - (Side “Bet” #1) - CLARITY 2.0
Treatment 3 - (Side “Bet” #2) - REMAP-CAP
New: Treatment 4 - Diabetic Kidney Disease (DKD)
Disclaimer: We are NOT biotech experts - this document is used by our team internally to try and track the company’s progress towards drug commercialisation, it should not be relied upon by anyone to make any decisions. For all disclaimers and disclosures please visit our website.
Our Big Bet:
DXB re-rates 10x by successfully commercialising its drug through Phase-III clinical trials.
NOTE: our “Big Bet” is what we HOPE the ultimate success scenario looks like for this particular Investment over the long term (3+ years). There is a lot of work to be done, many risks involved - just some of which we list in our DXB Investment Memo. Success will require a significant amount of luck. There is no guarantee that our Big Bet will ever come true.
What does DXB do?
DXB is an biotech research company that is developing an anti-inflammatory drug to treat respiratory and kidney diseases, with potential applications to treat COVID and Chronic Obstructive Pulmonary Disease (COPD).
Why did we Invest in DXB?
The DXB story has evolved over time…
Even though DXB is an early stage biotech, it has three Phase 3 Studies (the final study phase before commercialisation).
When we first Invested in DXB there were three “bets”, DXB has subsequently advanced the bottom two treatments:
Main “Bet” - FSGS
Side “Bet” #2 - REMAP-CAP
Side “Bet” #1 - CLARITY 2.0
New: “Main Bet” DKD Trial (See Slide X)
Bonus? Chronic Obstructive Pulmonary Disease (COPD)
Treatment 1 - (Main “Bet”) - FSGS
Treatment 1:
More on our main “bet” - FSGS
Focal Segmental Glomerulosclerosis (FSGS) is a rare kidney disease (orphan disease) characterised by inflammation and scarring of the kidney’s filtration unit.
There are currently no FDA approved therapies and the only solution for people with this debilitating kidney disease is a kidney transplant (which is very expensive and requires a long waiting-list).
Kidney transplants are not cheap. In 2020, the average cost of a kidney transplant in the US was US$442,500.
Estimated addressable market in excess of $1B.
DXB’s FSGS treatment is an Orphan Drug - meaning significant government incentives exist to bring it to market.
Treatment 1:
Market dynamics for main “bet” - FSGS
We think these two slides from a May 2022 presentation are really important.
Key takeaway: increased market appetite over the last two years for kidney focussed treatments.
25 August 2021 - Phase 3 Study in FSGS Kidney Patients Commences
Progress on main “bet” - FSGS.
Phase 3 FSGS commences with first ethics submission in Australia.
At this stage DXB was targeting up to 167 clinical sites across 18 countries.
DXB now has to get regulatory approval in each target country.
FSGS Study Design:
Key catalyst: Interim analysis
DXB expects this in H1 2023
1 February 2022 - First Regulatory Approval in Europe for DMX-200 FSGS Study
This was a major win for the FSGS study.
Denmark approval we think means the rest of Europe target countries should follow.
DXB also confirmed that they had selected 73 of the planned 75 global sites (97%) across 12 different countries to conduct part 1 of the phase III study.
Of the 75 sites globally today's approvals gives DXB access to the 15 of these sites which were planned to be in Europe, this is in addition to the 5 sites to be set up in Australia.
This happened faster than expected.
Later, in a February 2022 presentation, DXB releases a list of current & pending regulatory approvals… interim analysis expected H1 2023.
Another major bit of progress for DXB
The US FDA approves DXB’s Investigational New Drug application paving the way for patient recruitment in the country
US is a key market for DXB’s treatment and this was the last of the 12 jurisdictions that the company was targeting
31 May 2022 - Phase 3 FSGS Kidney Trial First Patient Recruited
First patient recruited for the FSGS trial.
This is the beginning of the ‘recruitment and data collection phase’ of the study, leading up to the interim analysis.
DXB remains still on track for first results in H1 2023.
What’s next for DXB with Treatment 1?
Treatment 2 - Side “Bet” #1 - CLARITY 2.0
Treatments 2, 3:
More on our side “bets” - COVID
DXB’s drug is an anti-inflammatory medication, so the company is also progressing two Phase 3 trials to see if it could be used in the treatment of moderate and severe COVID. It isn’t a vaccine so it promises to be useful across all strains of COVID.
REMAP-CAP = moderate COVID investigator-led study in 21 countries.
CLARITY 2.0 = severe COVID investigator-led study in Australia, Malaysia and India.
Important: �Investigator-led studies have a certain set of pros and cons. The main trade-off being reduced cash burn vs operational oversight..
In other words, as DXB has limited oversight over these two trials, keeping them to a timeline is harder.
10 October 2021 - DMX-200 CLARITY COVID-19 Study Approval in India
Progress on side “bet” #1 - regulatory approval in India.
Study protocol to recruit 600 participants with COVID-19 overall, with a safety analysis conducted after the first 80 patients.
15 October 2021 - Phase 3 DMX-200 COVID-19 Study Expands into Australia
Clarity 2.0 expanded to include Australia.
Six sites initially planned across New South Wales, Victoria and Queensland.
As of October 2022, there were 26,448 active COVID-19 cases in Australia, and approximately 1,500 patients hospitalised.
23 December 2021 - Ethics Approval in Australia for Phase 3 COVID-19 Study
Side “bet” #1 gets ethics approval (Treatment 2 - Clarity 2.0).
Restrictions set to ease,
BUT
There are still 33,140 active COVID-19 cases in Australia, and approximately 850 patients hospitalised.
18 August 2022 - CLARITY 2.0 COVID-19 Study Concludes Recruitment
Recruitment closed early - study has 49 enrolled of the target 80 for in the study.
This will enable faster reporting of results.
While we were disappointed that the trial couldn’t hit the target we’re glad that we’ll see results sooner.
AND
We’re also aware that COVID is waning as an urgent priority - this was a “side bet”.
What’s next for DXB with Treatment 2?
Treatment 3 - (Side “Bet” #2) - REMAP-CAP
(Reminder) Treatments 2,3:
More on our side “bets” - COVID
DXB’s drug is an anti-inflammatory medication, so the company is also progressing two Phase 3 trials to see if it could be used in treating both moderate and severe COVID. It isn’t a vaccine so it promises to be useful across all strains of COVID.
REMAP-CAP = severe COVID, investigator-led study in 21 countries.
CLARITY 2.0 = moderate COVID, investigator-led study in Australia, Malaysia and India.
Important: �Investigator-led studies have a certain set of pros and cons - with the main trade-off being reduced cash burn vs operational oversight.
In other words, DXB has limited oversight over these two trials, so keeping them to a timeline is harder.
16 December 2021 - DSMB Recommends Continuation of Ph3 COVID-19 Study in Europe
Patient recruitment update for side “bet” #2 - REMAP-CAP (Treatment 3).
39% increase in 4 weeks - total of 662 patients in Europe alone.
Data Safety Monitoring Board (DSMB) recommends the study continue.
This was near the peak of the first wave of the omicron variant.
11 January 2021 - Patients Dosed in DMX-200 COVID-19 Phase 3 Study in India
First dosage is in, now to wait…
Interim data safety analysis for REMAP-CAP will be after first 80 patients in India expected in the first quarter 2022.
28 February 2022 - DSMB Change to REMAP-CAP COVID-19 Study
A roadblock is encountered in side “bet” #2.
Data Safety Monitoring Board (DSMB) has “safety concerns related to the use of angiotensin converting enzyme (ACE) inhibitors and angiotensin receptor blockers (ARB) in patients with severe COVID-19”.
Effectively meaning:�A pause is placed on this study.
Our analysis…
27 June 2022 - REMAP-CAP COVID-19 Study Analysis Update
REMAP CAP Study closes recruitment.
“The study closure in non-critically ill patients is not based on any further safety concerns but is instead a pragmatic decision…”
Results to be reported as soon as they are received.
Again:
COVID is waning as an urgent priority - this was a “side bet”.
What’s next for DXB with Treatment 3?
New: Treatment 4 - Diabetic Kidney Disease (DKD)
Treatment 4:
More on Diabetic Kidney Disease (DKD)
A third of people with diabetes develop diabetic kidney disease (DKD), the leading cause of end-stage kidney disease (ESKD) requiring dialysis or kidney transplant, and it’s a major risk factor for cardiovascular disease and premature death.
DXB’s Phase 2 study was promising in terms of safety and efficacy but did not satisfy the primary end point.
Meaning: DXB needs to follow this up to prove the treatment works.
DXB entered an agreement with the Australian Centre for Accelerating Diabetes Innovation (ACADI) to commence a clinical trial on diabetic kidney disease - expected Q4 2022.
What’s next for DXB with Treatment 4?
Bonus? Treatment 5 - Chronic Obstructive Pulmonary Disease (COPD)
Initial results from a trial in mice look very good to us. Lung injury from COPD (damaged that can’t be reversed) was reduced by 80%.
This could imply that a similar thing might be achieved in humans suffering from COPD diseases like emphysema and bronchitis.
This was an unexpected bonus.
Trial planned for H12023.
9 August 2022 - New Patent Family Application for DMX-700
After the promising mice trials for COPD, DXB announces a new patent family application in Australia.
We think: good move to secure IP early.
What’s next for DXB with Treatment 5?