Chris Heminway, Exec-Chair at Time To ACT, explains why now is the right time for the Group to IPO. Watch the video here.
The XF-73 Nasal trial is mirroring competitor Ondine, first Ondine said they were going to trial 10,000 patients, then they had to cut that to 4,400, now it seems to be have a moved up again a bit to 5,000. At any rate long term prospects here look OK, but a fund raising in a few months is inevitable imo, without that their negotiating position wil be too weak, also likely to be something of a news drought for a few months, with most of the action in H2.
Certainly someone needs to fund their mooted very large phase 3 trial in the US, that what was presumably what the now departed JP Errico was brought in to try and arrange. A trial of that size (4,400 patients) would normally cost the best part of 200 million dollars and is many times the size of a typical Phase 3. It is not clear how much having HCA as partner will help with this. Meantime they seem to be raisng funds on a quarterly basis.
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.
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.
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.
I wonder if the CEO has something left field up his sleeve re XF-73 Nasal? Otherwise the M3 switch looks an odd decision, from DEST's perspective the best time to switch to a solid formulation would have been post Phase 3 but before market release giving them plenty of time in parallel with Phase 3 for preparation and disolution equivalence testing. Does the CEO really think that using a liquid formulation might actually impact Phase 3 through non compliance??
The NIAID study was a pure safety study not a safety and efficacy study (they do both types), so you would not expect any efficacy data to be released since it was not part of the study. Expecting a US Gov't agency like NIAID to release it regardless is very optmistic and you can infer nothing from its absence other than that is how the system works.
Re-running p2 for M3 is/would be very different in delay terms from the pre announced reformulation and simple dissolution equivalence test for p3, and is the main reason for the the SP fall.
Data on the efficacy of XF-73 Dermal against MRSA was in fact released in July.
https://www.destinypharma.com/2023/07/31/publication-of-new-data-for-xf-73/
While the possibility of re-running p2 for M3 by Sebela was hardly "old news" AFAIK.
The closed period for AIM shares was changed to 30 days for all results some years ago I believe. It does not matter imo how many shares or warrants the directors have - ime, if the potential here is as large as we like to believe it is, to see no director buying at all this year seems a bit suprising. There will have have been periods this year when they could not buy of course, but equally there will have been periods when they could.
If unexpected news is imminent and known to them they cannot buy, but they haven't bought at any point since they started producng good drilling etc results and talking about giant systems. They have not been blocked all that time
Bradda Head Holding Shares (from the pre listed co) are the ones trading now at 5.75p. Because of the 1 for 10 consolidation into BH Holdings, old shares in Life, the RTO vehicle, are effectively worth only 0.57p. All this should be picked up automatically by yourr broker but you may need to give them a nudge.
It was originally mooted as BRAD a couple of weeks ago, but now I see it may have changed to BHL, this would be pretty much par for the course ;)
https://www.proactiveinvestors.co.uk/companies/news/955100/bradda-head-to-list-on-aim-on-monday-with-highly-attractive-portfolio-of-us-lithium-assets-955100.html
Time to close this thread and open a new one on BRAD, as the long running farce moves to a new chapter, and since the Epic CDC is now 2 iterations old. The only +ve point, beyond a the bare realities of a relisting, is that BRAD looks a decent value proposition at the floated SP, at least to those of a trusting nature.
The telegrph article indicated it would float at 5.5p a share, following on from the 10 for 1 consolidation this amounts to 0.55p per old share?
AIm listing this Month according to press today
https://www.telegraph.co.uk/business/2021/07/03/mellon-list-lithium-miner-londons-junior-market/
Richard Bernstein buying shares today I see, I am not familiar with him, but I assume he is this guy.
https://www.rbadvisors.com/index.php?option=com_content&view=article&id=304&Itemid=495
13bln assets under mangement at his firm but this seems to be a personal investment FWIW.
My undesrstanding is that Motif worked very closely with the FDA to come up with a mutally acceptable trial design post the initial failure, and that design was intended by both parties to address the shortcomings of the the Linezolid trials. On that basis it might be a little difficult for the FDA to turn around and say, sorry the original trial results still rule this out, even though we agreed and fast tracked this new trial design, with its new dosage regimen delivery profile etc and the results were ok.
But who knows.
The dilemma of the DBC, where trading seems largely nominal, is summarised here. https://www.*************.com/views/29633/jim-mellon-s-diabetic-boot-company-spoof-unravelling-as-late-accounts-filed It seems they may well need further expensive (potentially very expensive) and time consuming trials to get those coveted reimbursement codes, that is the reason, I suspect that wannabe investors have been thin on the ground. it is no suprise JM seems to want someone else to fund these. Meanwhile, I expect LIFE is still merrily paying Director's salaries, and naturally nothing has been put on its website re the 'loan'.