Ryan Mee, CEO of Fulcrum Metals, reviews FY23 and progress on the Gold Tailings Hub in Canada. Watch the video here.
Nice to see this “ Avacta seeks to create long-term shareholder value alongside patient benefit.” putting SH value first and foremost
This is currently a loss making business. A change in strategy is needed which I hope the change in CEO indicates. On the to do list I’d like to see them divest the diagnostic business and use the funds to pay off the bond plus get some deals in place to become cash generative - you can’t be too picky while we are bleeding cash.
They might be keeping the update back till tomorrow (on reviewing the first cohort of the 2 weekly trial) for CC to release - thereby turning the page and putting her own stamp on how best to be updating SH on AVACTA progress with AVA6000 and how best to maximise the value?
Good luck to you sheppy / I’m in Dubai currently by a pool looking at the Burj Khalifa & I’m travelling round the south of France for a month in a couple of weeks time - no permanent oversea residences for me but I’m happy staying in Avacta! 🥂 and certainly hope the shorters here get burned next week GL
Yes one of the more dubious calls being spending more money on acquisitions to add to the diagnostic side when the clear value driver seemed to already be proven through AVA6000!
News could also be from Dr Simon Bennett the Chief Business Officer bringing his 26 years' commercial experience in the biopharma industry (so hopefully more competent than todays RNS authors). Simon has worked with companies from large and mid-sized pharma such as Bristol-Myers-Squibb and Menarini Group to early stage biotechs, supporting business development and licensing activities in addition to being involved in all aspects of business and corporate development. Simon has been involved in over 80 (soon to be 81?) commercial deals across Europe, North America, Australasia, Japan, Russia/CIS and South America. 🤝GLA
Definitely taking the p now “ These arrangements continue to align the interest of the Executive Directors with the longer-term share price performance interests of our shareholders.”
I’ve submitted a question asking how well they think they’re doing on their mission statement about growing shareholder value? & when we might see value reflected in the share price.
Yorkshire - Looking at what the Dec RNS stated, to increase efficacy data is what the two weekly study has been designed for - “The next steps with AVA6000 involve optimising the patient population, dose and schedule in order to increase efficacy and tolerability of doxorubicin treatment via pre|CISIONTM targeting. That Dec RNS also stated that safety data had been obtained and this has later been reported at the AACR conference along with the unexpected efficacy data from the 3 weekly study (unexpected because this population wasn’t selected for efficacy - which I believe the two weekly population will have been selected for) we have been told the first cohort weekly cohort data will be reviewed at the end of the month by the SDMC so hopefully on the cusp?
Wyndrum - the FDA may be unwilling to grant AA in the basis of the safety data alone as this is what phase 1 trials are all about usually - the pivot to unexpected 2 weekly may be to provide greater efficacy data which could trigger AA?
Yorkshirepragma looking at the document you posted the link to, at the bottom of the table on page 3 seems to be likely where we are with AVA6000 - on the cusp of AA. After phase 1 but before phase 2?
It also mentions the FDA can grant AA and approve drugs purely on the basis of tumour reduction - a surrogate endpoint. A threshold we seem to have reached and this two weekly trial might be the pivot towards providing the data that the FDA would need?
Yes Thornogson but also this might be the whole reason for the two weekly trial to prove decisive data to the FDA for accelerated approval? We know Avacta have been in discussions with the regulators and they have hosted big pharma. It could all change very quickly.
Slacker by the end of the month they’ve said they will review the first cohort of the two weekly trial
Looks like SH are spooked by the open short - becoming self fulfilling 😠
I must admit that I’m not liking this new commercialisation phase so far! GLALTH’s
Good luck Simon Bennett - hope you pass your probation review 😉
I’m just pleased it’s on my radar and also pleased I took advantage and bought a few more at 50p (not pleased at the 50p fund raise though). Two weeks to go until Al explains his reasoning and I think he has timed it to coincide with the end of the two weekly trial (which if this was influenced by the FDA could mark news that inspires a significant upturn in SP🤞). GLA
Certainly hope not Livedataaccount! 😝
So if AVACTA are to submit an application for breakthrough therapy designation (and why wouldn’t they ?) for AVA6000. Based on the reported reductions in side effects (notably cardio toxicity) and safety improvements this should be a given. It’s also likely to be well before the efficacy trials are due to start and following the two weekly dose seems most likely - this could even be why this two weekly trial was introduced?
*Should submit an application before the trial(s) aimed to confirm efficacy