focusIR May 2024 Investor Webinar: Blue Whale, Kavango, Taseko Mines & CQS Natural Resources. Catch up with the webinar here.
This is the point where the ' partners ' come in I guess .
They needed this approval in order to actually design further studies and be able to make a deal - up to this point it was hypothetical . Now - they are good to go - so can actually go ahead and partner up .
Also another box ticked here
Project Optimus -
https://www.fda.gov/about-fda/oncology-center-excellence/project-optimus
Greenlight from FDA for next stages - great stuff .
Validated biomarker accepted - so they can select patients
1mg/kg dosing selected as ideal - so massively safe level
"We are pleased to have received these positive and supportive FDA recommendations for the continued clinical development of bexmarilimab as a monotherapy in solid tumors," said CEO Markku Jalkanen. "As a first-in-human study for bexmarilimab, MATINS has laid the groundwork for multiple routes to market."
Looking back my experience with Gold Miners in the old days I always seemed to be buying high and selling low . Too much rainbow chasing back then . Got lucky with GGP and rode that to the top , but now more cautious at believing the hype etc . So many Miners are now fractions of what their SP used to be . Many look like bargains - its hard to choose .
It took that Sale RNS to get me back in . Lucky the market took a while to cotton on . So happy now that I'm fairly insulated to any drops , and will see it through to the conclusion .
They presented the Bexmab data at the AACR special conference in Austin in January , but also have the AACR conference in April booked in their website calendar 14-19th April . No more details , but I'd expect them to put out some kind of data update for that .
Also found this 'Coorperate Presentation' pdf that was done in March 2023 - a bitesize Bex summary and sales pitch .
https://www.faron.com/sites/default/files/2023-03/Lis%C3%A4ykset/Faron%20Non%20Conf%20Corporate%20Deck%20March%202023%20(4).pdf
The meeting was going to happen in March , then I think Markku said about a month at latest to get their report .
So I would guess mid April ( as things always come a bit later than we expect)
But I'm expecting Bexmab news imminently - be it latest patient data , sites , or even more .
But perhaps the suitors for the AML side are also the suitors for solid tumour Bex , so they are waiting for the FDA news so they can make a proper offer ?
They must be super busy , but for us its exciting but also frustrating as we always seem to be waiting for news lol
Have been in and out here for years .
Was currently out , but at 17.5p , also happy to come back in now .
Its been a long journey for LTH's I'm sure . I held for a couple of years , but like many got bored with the story , despite advances being made .
But now it looks like it really may come to fruition .
Lots to look forward to . Shaun as fired up as ever . Always a bummer question about a flagging SP . Nothing he can do . Just let the drill bit , the management , and the mine development sort that out .
Sit back , enjoy , and top up . That's all we have to do .
And another approval for a drug supported by LLS .
https://www.lls.org/news/fda-approves-new-formulation-important-childhood-leukemia-drug?utm_source=Twitter&utm_medium=Social&utm_campaign=03-08-2023-LLS-FDA-Approval-Childhood-Leukemia-ZGM
I think one of the biggest recent helpful steps in the LoA chances - was teaming up with LLS .
Another article here (published in jan2023)
Talks of how the Bexmab trial had increased the likelihood of approval - by this point - initial data had emerged about complete and partial responders .
I had not seen this article - but recently I seem to keep finding these kind of nuggets hinting that Faron may be onto something big .
https://www.pharmaceutical-technology.com/data-analysis/bexmarilimab-what-is-the-likelihood-that-drug-will-be-approved/
and that's just for the first deal.
Faron could partner multiple times .
Humongous indeed - enormous , immense , giant , extremely large , very big .
Only one thing you need to know , is once you go Humongous , you never go back .
Many thanks Sophie .
What a great write up .
Pharma Intelligence is a massive group - according to them they are the trusted partner of the 50 biggest Pharma companies in the world and the top 10 research organisations .
So this isn't just a RedEye press blurb - someone has actually written their own article , and for a large important readership base.
Great PR for Faron
Article today ..
https://scrip.pharmaintelligence.informa.com/SC148010/Faron-Set-To-Fly-As-Bexmarilimab-Shows-Promise
Data have shown that the Finnish firm's bexmarilimab has the potential to be the first macrophage immune checkpoint therapy and big pharma are getting interested in a licensing deal.
my mistake , this ones a virtual conference ( so they'll have to eat their own nibbles lol )
Even so , its a good sign that Faron are out beating the drum .
Another example -
Dr Juho is in London today , also on a panel at the Medidata NEXT event talking about early stage science development.
CG Horizons In Oncology Virtual Conference.
panel: Boosting checkpoint inhibitors – finally two solutions? Bioxcel Therapeutics & Faron Pharmaceuticals
Looks like Faron are confident about what they have - now to appear on a panel talking about CPI boosting .
For an investor , this is either a very large trail of breadcrumbs we are getting , that in a few months will seem in hindsight to have been a great signal of things to come , or it will just be a load of scientists flying around the world for drinks and nibbles .
Maija is in Banff with Bexmarilimab poster at a key conference this week . Sponsored by some Big Pharma companies.
https://www.keystonesymposia.org/conferences/conference-listing/meeting?eventid=6906
She will be presenting new data on the molecular characteristics defining bexmarilimab response.
Video up on Faron website also
https://faron.videosync.fi/2022-financial-statement
One of the best so far - confident - excited and I got the feeling that they know its happening for sure now .
Toni - very relaxed regarding future funding - their excellent track record of raising money in EU . Nasdaq there if needed .
They answered 2 of my questions. Although the Bexmab one , I asked about possibility of an EUA . They took that as meaning a European Application ( whatever that is ) . Either way the answer was that US was the bigger fish and that was what they seem to have as the ultimate goal .
The other was about Tuomo - and was the most interesting answer of the Q&A
Tuomo brought in for the commercial experience to assist negotiating licensing deals . He's done multiple deals over his career in similar situations with small and big pharma . And now moving into negotiations of licensing and also plans for commercialisation of ( and here he says 'Bexmab opportunity , but corrects it to Bexmarilimab ) .
In his words , they have to be very careful at this point - to make the right decisions .
Do you sell the Golden Goose , or be smart and sell the first golden egg , that will keep the eggs coming .
Looking at the team they have amassed , they are all still relatively young . Even Markku and Toni look as fresh as I've ever seen them .
Maybe there will be a takeover at some point - but I'm leaning towards an empire building plan being worked out . Bexmab could be the front runner for licensing , and the imminent FDA meeting giving green light for further collaborations .
The addition of Tuomo is key now to the next move .
I wish them all the best luck - and have upgraded my outlook from SSV to HSV .