Roundtable Discussion; The Future of Mineral Sands. Watch the video here.
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Talk of the Devil and he appears, you must be following me Brooko to know when I post as you haven't posted since as couple of weeks ago. I'm happy with my buy at Hemo as Cart-T trials are about to start. Yes they needed a raise and the price dropped but am more confident there than here when I sold as look at Dest's sp now! It's going to be a longer game here and they'll need to fund raise before Sept. I have said I'll be back here when better news happens. As yet CT hasn't managed to secure a deal so I guess people are selling because of that, money is in short supply. My guess is that a raise will come soon and only those in the know will find out the day.
Are you still happy to hold Brooko as you said the fundamentals are sound? I dare to suggest that something is going on which the small pi's are not privileged to.
I repeat: : Dear Mr Tovey and Sir Nigel, may we have an update please?
Think I asked this generally one week ago. Today I can make it a little more specific "what caused today's drop?'
Surely not a fundraise?
Thanks in advance of your reply or shouldn't I hold my breath in expectation of it.
Volume was over 500k today so sold volume will be much more than 150k
Like you did Alamo when you sold and bought HEMO at 4p
😎
Based on the recorded volumes of shares sold, (150k), talk of a seller causing this drop is somewhat hard to believe.
What info do you have which suggests this is cheap?
I’m adding at these levels. I think a seller is still not quite finished, it might dip a bit more but I think the risk of missing the upside is high and not worth trying to exactly time a bottom.
Also there’s only a few more trading days left for tax loss selling.
....or half it the way the sp is going😏
Great Opportunity to double your money!
ATL 25.5p
Feels like an equity issue or some other bad news coming along.
I had thought with Rudd on the Board they would at least have their Governance in order. Maybe that was rash.
...the share price is suffering a bit of a collapse today.
Quoted 27.5p to buy, which I think is an all-time low.
Company is funded through to Q1 2025, which presumably means a placing will be required towards the latter part of this year...
Yes, it costs 20-25million PER TYPICAL PHASE 3 trial - but cost is PER PATIENT. Usually, as in M3 only one is needed. Xf-73 nasal needs multiple phase 3 trials because the FDA will not allow its general use based on single procedure trail such as hip replacement. That is why OND have applied for a 4,400 patient trial effectively rolling them all into one, they are not recruiting that many patiens for fun, but because it essential to unlock the US market. If it only required one 25million Phase 3 trial to unleash a 2 billion mkt in the US, big pharma woule be biting DEST's hand off.
Ive looked at 3 sources of information on the costs of Ph. 3 clinicals. All come up with similar numbers; around $20 - $25m for trialling an Anti-Infective drug using a placebo comparator. Interesting that the most expensive P3 trials are for Pain and Anesthesia category drug ($53m) and the least expensive are Dermatotology ($12m). These are just averages and the cost will depend on the number of patients in the trial. Due to the high cost and time of a Ph3 trial, the partner is only going to do it once - it doesn't make sense to do 1 or 2 small Xf-73 ph.3 trials first, as you are suggesting - that's what Phase 2 is for.
Yes, M3 will probably happen more quickly than XF-73, but since the market size for the XF-73 platform is an order of magnitude greater than that of M3, then XF-73 is undoubtably the lead product, IMO
The costs for OND and DEST, which I don't think will be that dissimillar on a patient basis, are very relevant, as is the number of Phase 3 trials required and the no of patients per trial. The cost of getting Xf-73 through enough Phase 3 triails to fully unlock the US market looks likely to be well over $100 million imo, a lot more than M3 which just requires one 700 patient trial.
Also, if the potential partner wants to do just one or two Xf-73 Phase 3 trials initiallty, there will be a long delay, five or six years for more Phase 3's, before those Xf-73 nasal benefits can be fully unlocked. For that reason imo M3 is arguably the real lead product in the medium term, which makes it doubly odd that we are now facing an potentially avoidable lengthy additional delay there, in what may be the kind of decision a purist COO might recommend internally and a CEO normally override.
From this site
Shares in Issue 95.27m
Market Cap. £29.53m
Market Size 1,500
PE Ratio -3.33423
Earnings -9.2975
Dividend 0.00
Yield 0.00%
And any feedback from the conference in Barcelona on the 18th?
Thanks, Tllerman and Reserved for your useful posts; however, I am not sure that the cost per patient of Ph. 3 trials at Ondine is relevant to that of XF-73. Even though XF-73 and Ondine are in the same space - combatting AMR, they use radically different methodologies. XF-73 is a drug, taken by the patient before and after surgery. Whereas Ondine uses a device that photo-disinfects the surgical area using a form of laser treatment. So, in one case you have a very large number of capsules each of relatively low unit cost and on the other you have an expensive medical device, one for each operating theatre. Both may or may not be great solutions to the problem, but as far as Ph. 3 clinical trials are concerned, the clinical trial plans, numbers of patients and costs will be entirely different.
In the case of XF-73 I am sure the cost Ph. 3 trials will run to many millions but that cost will be bourne by the partner in terms of up front and ongoing cash, in exchange for a share of the royalties. I don't think it is the intention for DEST to cover the trial costs directly by themselves.
Tillerman
Thank you for an excellent post providing information about the cost of a trial.
Your reference to Ondine prompted me to review their Half Year Report (25/09/23); the report includes:
"FDA approval
We are continuing to work with FDA as well as our partner HCA Healthcare on the planning and execution of the pivotal Phase 3 study. Following a recent review meeting held with FDA on September 22, 2023, we can confirm that FDA has agreed that Ondine's summary of the extensive safety data is sufficient to proceed into the Phase 3. We are now working closely with FDA on specifics of the Phase 3 protocol."
QUESTION: Does working with their partner HCA Healthcare mean that the cost of the trial per patient could be significantly reduced?
Dear Mr Tovey and Sir Nigel, may we have an update please?
I think you make some great points, Volmer. The Sabela deal was poor, not only because of low upfront, but that we were forced to raise funds to strengthen the balance sheet. I think CT would never have made such an agreement. NC must have felt he had to deliver a deal, even a poor one. I think NC was out of his depth. CT has effectively said it’s more important to get the right deal, even if it takes longer . The other big difference is that XF-73 is a much bigger fish than M3. AMR is a much bigger health issue than C- Difficile, and big pharma need to crack it. So, we have the power and the experienced team to deliver a very good deal.
Tillerman, nice post. Are the XF-73 negotiations are taking so long? When you think about it this is a major investment decision for big pharma. Blue chip companies are rigorous in their investment decisions. A big issue for Destiny is the up front payment for any deal.
For M3 Sabela committed to $20m with only $1m paid up-front. That is the problem. JV companies may be looking for a similar deal that is not up for grabs now, IMO. That’s why we have Nigel Rudd and Chris Tovey in place. The new Destiny team will want something substantial.
For the up-front payment I’d be looking for around $40m, perhaps half of what has been spent on developing M3. The trouble is M3 has set a precedent that new management will want to kick out of the ballpark.
Sp on the up, and good long term prospects here, just not so sure about the short term ones. Long term strugglers Ondine who are chasing the same market segment in the US as Xf-73 nasal seem to have a p3 plan submitted for 4000 patients for their solution. The number is so large because it addresses multiple applications (operation types - effectively multiple p3 trials bundled together) which is necessary to unlock the US market fully thanks to FDA regs, but is also likely extremely expensive, while infectivity p3 trials are cheaper than many other types, they seem to be still typically priced at around 35k dollars per patient (see below)? Dest can get away with fewer trials (certainly initially) as they are not tied to an enabling machine like OND, but still the cost of multiple phase 3's and the artificially fragmented US market is quite likely why discussions here are taking so long imo. Having to apply the treatment five times?, albeit in one day, is not ideal either.
https://www.statista.com/statistics/1197095/clinical-trial-cost-per-patient-by-therapy-area/
If they have to rerun Phase3 for M3, even if Sebela are paying, that will further cloud the medium term prospects imo.
"Normal" trading seems to be back. Price now reflecting this.
I do wonder sometimes, these share price drops are crafted, so insiders can sell high and buy back low!