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@Sieveco, have a read of the Turner Pope note, especially pg 6 - is a lot clearer on strategy and timelines than they have previously been and is obviously coming from the company.
Suggest P1a ongoing as no MTD; P2 starting H2 2024 and taking 18 months.
Commercialisation starting in 2026, Phase three also in 2026 - so seems like they are aiming to get rapid approval for Orphan Use to get out there immediately, then use the P3 to target the entire Doxorobicin market
Doesn't answer all your points but hopefully helpful
https://mcusercontent.com/d9ebd7c1aa0f3dbc5fab42eca/files/0131e630-3c92-ac71-831a-e2175441110a/AvactaGroupplc_29_2_2024_FINAL_BG.01.pdf
I agree there's serious questions for the CEO and a need for senior leadership changes, but no-confing the CEO now will just destabilise the company and paralyse decision making for several months while they find a replacement, keeping the SP in the sewer while its fought out.
Al does need to move to a science focused role and step aside from running the business to make way for a more hardened pro. But for all the mistakes, even this morning the Mcap is £157 million, which isn't bad for a university professor with a passion for science.
That said, they do need to urgently explain what the f they are thinking and the status of the trial, especially wrt to strategy, as atm their credibility has evaporated IMO
Would someone with a subscription mind copy/pasting the article? Thanks!
Re lack of data: If I remember correctly, in previous presentations by Alistair at the start of the trial, they suggested they would not be able to release data from the trial until its conclusions, owing to 'ethics considerations' - he was quite forceful about it at the time.
Given the trial is being run and reviewed externally, I imagine they need sign off from the trial supervisors to release information. While the trial is running (and thus still recruiting patients?), I would suspect theres a lot of quite stringent ethics legislation in place - perhaps anyone who knows more can further clarify.
That said, the latest video says very clearly they have improved efficacy, which is the first time they have confirmed that I think. Given the current dosing levels, its obvious safety has been improved, so I think the signs are there if you look for them - just a waiting game now.
Fantastic news today which makes clear the platform is working as intended. After a long wait its truly amazing to see todays news - well done to everyone who has held this share for a while!
Out of curiosity, what do people suggest might be the next steps for the company?
Obviously, with the trial ongoing, there is a way to go before AVA 6000 is commercialised - though the FDA Orphan Drug pathway and availability outside of the trial suggests this might happen faster than one suspects.
However, do people think the public release of this data makes a licensing deal more likely - for example, regarding the Velcade asset?
Curious to hear peoples (speculative) thoughts!
Yeah that's it really - Al looked v downbeat on the LFT and couldn't give any timeline on resolution. They have £30m in the bank but clearly they will get funds from somewhere at some point, so all or nothing on the trials really (which do seem to be going well).
Plus also there is a general bloodbath in biotech stocks across all major exchanges atm; on AIM pretty much everything except Angle and Synairgen has tanked
Thanks for sharing - interesting to see on the last page they have a US Investor relations person listed, are they new?
US Investor Relations TKDY Advisors, New York Thomas Lawrence Thomas@tkdyadvisors.com www.tkdyadvisors.com
The company guidance in yesterdays video was for summer and, despite some COVID delays, they were on track for this.
But given the COVID backlog in hospitals and that the data is contingent on external consultants/clinicians, I'd wager that late Q3 is more likely than late Q2 - when the US hospitals come online will probably be a good indicator; if that happens in the next few weeks perhaps they'll keep to schedule.
Thanks for that Alistair, I might even buy some more shares - can anyone here lend me a tenner because the ones I bought last year have...
What are the risks with FAP a activation?
Fiona - "expression of FAP is not the same as FAP activity, you can get some background FAP from surgery [etc] but there is a difference between FAP being present and it being active and cleaving the prodrug"
Monitoring through Plasma levels and tumor biopsies - alongside archival biopsies - to examine FAP activity.
Newflow:
Prelims out in early April/late March.
Oncology is main driver now, progress of trial and 3996 with IND next year. Partner programs 'extremely well' - "Lots to come this year"
"WE'RE NOT LOOKING TO RAISE FUNDS IN THE NEAR FUTURE AT ALL"
Safety studies on AVA 3996 by CRO's and working closely with external safety consultants - unanimous is conclusion data shows safe to progress to clinical trials
What does is mean for the company?
Alistair: "we're not just evaluating AVA 6000 but the entire PreCision platform. The data in middle of the year is a huge value inflection point - the potential value for the company is enormous, its a massive milestone for us. It unlocks the entire existing pipeline of pro-drugs [and also further drugs not yet analysed with the platform]"
On funding for Phase 2/further expansion:
"Broad range of options I'm sure everyone can figure our. W/ the clinical deal we could form a license deal around AVA 6000 or the entire PreCision platform. To maximise shareholder value we want to develop some candidates ourselves, but we are in a strong position with a good balance sheet"
All patients are terminal stage (here's hoping for them in works, I'm sure we all wish them well)
PK data at end of first phase of escalation, but anticipated mid-year forwards.
Very happy with data, is very consistent, "but very early stages so not appropriate to set up any signposts yet but we're very happy with what we're seeing so far"
looking to get two more US centres set up as part of the same study to contribute to Stage 1a and 1b
Into the AVA 6000 trial after the first 4 minutes:
Fiona takes over; says the real measure in doxorubicin is cumulative lifetime exposures; says the difference between standard and pro-dox could be 'very different' so this is a key marker.
In addition to monitoring plasma levels and urinary excretion, they are taking tumour biopsies wherever they can
Safety committee reviews data every fortnight
Slight covid delays but on track for Q2 escalation as previously stated
Al starts with the LFT and basically admits they f*ucked it up - "despite the obvious disappointment and delays with the antigen testing revenues, fortunately the oncology side of the business is the main value driver"
Says shouldn't be long to replace the antibody, though is unclear how regulators will view the reformatted test so no clear timescales
(I get V0X markets notifications on my phone) - is with Alistair & CSO Fiona McLaughlin...
I'm wildly guessing but I would hazard it would prevent any company being able to so easily establish the boundaries of their IP and place a value on it, so as to make a low-ball/hostile takeover harder. Now if anyone wants to have a look, they have to at least knock on the door...
I noticed this the other day and this post prompted me to look on the Wayback machine: it looks like there'd been some hiring and firing in the diagnostics leadership team, which isn't surprising after the LFT farce:
- Mary Bronserud has been replaced as Operations Director by Adrian Ruskin
- Gemma Wilson joins as head of QA/RA at some point post September 2021
- Fran Mullen leaves the commercial team as former Senior Manager, Business Development for North America
https://avacta.com/diagnostics/
Site as of September 2021: https://web.archive.org/web/20210909113055/https://avacta.com/diagnostics/
Maybe this is old news but thought I would share
Worth remembering that pro-dox would, if all goes well, take market share from the other anthracyclines - eg Epirubicin - as many of these were developed to try and reduce the side effects of Doxorubicin, which remains ones of the most effective drugs in the anthracycline class.
Therefore if pro-dox has a significantly enhanced safety profile, if would likely become the front line anthracycline in many instances - which is a much bigger market than Doxorubicin alone.
Let's hope they get it over the line as not there yet, but looks very positive this morning!