George Frangeskides, Chairman at ALBA, explains why the Pilbara Lithium option ‘was too good to miss’. Watch the video here.
Also - they seem to now have a commercial solution in place for Interferon Gamma biomarker testing , if I'm correct in what I heard , as that is not something regularly used in clinics ?
Sounds like they are working now on really fine tuning this package to hit the ground running when approval lands.
Just watched it . seems to cut off halfway through questions which is a shame , but you get most of it .
One new bit of info he couldn't spill details on was that having had time to study the data on M2-M1 conversion, they now know which signalling pathways are critical to obtain the immune system conversion .
He was really excited by this . Obviously a key element to proving up the thesis to the regulatory bodies .
So again - things are even better than we know .
Also - those extra 15 patients have been recruited - and will have been 2-3 months into their treatment .
Again - Faron will have data on that .
Looking very relaxed and confident .
Markku will be at HC Wainwright today - link to interview now available
https://journey.ct.events/view/49b57636-a343-4751-a341-05413214441c
Thanks for that .
Juho has in the past always been a little less restrained in his thoughts .
Having said that , even Markku now is using the word ' humongous' in every interview.
The data is coming in . I am 100% sure that they are seeing , or already have data on those extra 15 or so patients in Bexmab that they need . Hence the build up in excitement in management . They will know very quickly if a patient is responding .
Personally I'm still buzzing from the announced involvement of Christine Roth .
Others however will be keen , and like you say - who moves first .
You snooze you lose .
Roche story today also highlighting how they too ( as well as Bayer ) are on the hunt for new drugs , that are already in clinical trials , and that are showing the potential to be blockbusters.
They are all competing with each other to be the top dog .
Faron really are at the 'Goldilocks' stage right now as far as getting noticed ( and snapped up )
https://www.bloomberg.com/news/articles/2023-09-11/roche-ceo-eyes-drug-failures-seeks-pipeline-productivity-push?leadSource=uverify%20wall
Yes , I think it was a good appointment at the time as they were trying to establish connections in the US . But things have moved on now . We'll never know if she helped with anything in particular , but the replacements sure carry a lot more weight . Not surprised at slight drift in SP . We've had a good move back to sensible price , but we still are running on speculation and associated news , such as CR . Fantastic as that was - we still need some hard news to back it up .
A few weeks (3-6?)until a Bexmab update . That will come with CR in place , and so finally then we will find out which direction Faron are going .
From that article -
Unfortunately, the results of the clinical trial weren’t as successful as the researchers had expected, based on preclinical models and a solid theory behind the drug. Of the 67 patients able to be evaluated for their response to the drug, only 32.8% had stable disease.
MD Anderson centre- is one of Bexmab key US sites - with MD Naval Daver investigating .
It's a small world .
Yes Luck , this appointment is very telling .
She isn't joining Faron out of curiosity or for a little retirement cash .
She is a big player , in a big company , that are actively looking to acquire new pipeline drugs with multi billion dollar potential .
No wonder Markku was twitching with excitement the other day .
Another article here - highlighting Bayers intentions .
CR opinion is that these days you need to be hunting for the multi billion dollar pipelines , not the small scale one off drugs that won't make a big difference to your turnover .
Faron have been talking to , and been on the radar of probably all the major Oncology Pharmas .
Bayer look to be the first to show that interest officially . Others may now have to show theirs .
A bidding war , should it occur , and its not unreasonable to suggest it , would propel us into the stratosphere .
Exciting times !
https://www.genengnews.com/gen-edge/top-10-ambition-bayer-aims-for-10-billion-in-cancer-drug-sales-by-2030/
I think Bayers ambitions in the Oncology market are quite big.
https://www.fiercepharma.com/pharma/bayer-needs-midsize-acquisition-reach-10b-cancer-drug-sales-goal-oncology-chief-says
Bayer recently laid out its ambition to achieve $10 billion in sales from its oncology business by 2030 and become a top 10 cancer drug player. To get there, the company is looking outside for a “midsize acquisition,” Bayer’s oncology chief Christine Roth said.
Right now, Bayer’s Nubeqa leads the charge in the company’s oncology department, with its sales projected to peak at more than 3 billion euros. In addition, the company’s acquisitions of Vividion Therapeutics, BlueRock Therapeutics and Noria Therapeutics in recent years have bolstered its research capabilities.
“We’ve done a lot of activity to fill our early pipeline,” Roth said in an interview with Fierce Pharma on the sidelines of the American Society of Clinical Oncology's 2023 annual meeting. “But if we want to achieve that top 10 spot in the next four to six years, it’s going to take the right midsize acquisition to get there.”
Roth agreed that $5 billion to $10 billion would be a good value estimate for a midsize M&A transaction. But she also said she’s not “putting a ring fence around the dollar value.” The deal would likely come with a later-stage drug, she added.
The right deal would also fit in Bayer’s focus tumor types and potentially within its three pillars of treatment modalities, Roth said.
This news might be a bit of slow burner , being Friday - and the juicy bit was hidden in the text of the RNS.
I had a top up on the back of it , and looks like market has woken up a bit now .
7% up on Nas , and we just lifted a bit too .
The significance of Christine Roth joining Faron after recent FDA designation etc - just points in the direction of success.
The newest incoming member is not your average person...
https://www.bayer.com/media/en-us/bayer-appoints-christine-roth-as-new-head-of-oncology-strategic-business-unit-at-pharmaceuticals-division/
Quite a catch !!
This is what the Bayers president said of her , when they hired her in 2022 .
Christine Roth is a highly accomplished pharma executive recognized for her exceptional track record in Oncology. Her in-depth experience and strong leadership capabilities will lift us to the next level, as we launch our late-stage Oncology pipeline and further clinically develop leading innovations to serve patients with the highest unmet medical needs," said Stefan Oelrich, Member of the Board of Management, Bayer AG, and President of the company’s Pharmaceuticals Division.
Christine Roth’s prior positions include executive and senior level positions at GlaxoSmithKline, Novartis and Bristol Myers Squibb, with a focus on global product strategy and commercialization, building oncology organizations, and new product launches.
From his comments he is saying -
P1 is basically done - they have the correct dosing chosen now ( 6mg/kg)
They are ready to proceed to P2 - which they are aiming at starting in Q4 2023.
Will they need funding for that ? Possibly some extra - but they are getting quick recruitment , and the way Markku talked , it is as if they are not even taking a breath before the next step .
Confident . Either way - to get a P2 done quickly would really boost the deal value .
Markku couldn't be more bullish . Reading between the lines - things are getting pretty ' intense' in the discussions .
2 years of talking - its getting to the nitty gritty stage I feel .
Further FDA indications to come perhaps also .
Funding - Yes James talks of having a very good shareholder base ( ie patient) - but also of other options on the table.
So - on paper - still the same - but Markkus excitement is a good 2 or 3 notches higher .
I think we may be closer than some think .
New Redeye report today
https://www.redeye.se/api/articles/download-file/3002fd9a-1559-3251-9aa2-d3d948ac2f80
Base case 5 euro - Bull case 12 euro - Bear case 3 euro .
Financials were as expected - slightly lower cash burn than expected .
They expect some kind on fund raise by end of year ( obviously) . Unless other news lands first .
Licensing deal
Should Bexmarilimab demonstrate proof-of-concept (PoC) in the combinational trials, we
believe it is possible that the candidate could catch the eye of Big Pharma companies.
Accordingly, we project a licensing deal being struck prior to pivotal trials. This could act as a
major catalyst for the stock.
Mainly, orphan drugs benefit from seven years of market exclusivity post approval in the US
(ten years in Europe) for the approved indication. The designation also qualifies the company
to receive tax credits for qualified clinical trials and exemption from FDA application/user fees.
Furthermore, according to a study by Monocl Strategy Services, clinical projects granted
orphan drug designation have historically had a significantly higher probability of reaching
market launch than the average pharmaceuticals.
The granted ODD could also increase the probability of obtaining a fast track designation from
the FDA (and EMA) in the future. This would increase regulatory support from the authorities
in the clinical development of bexmarilimab and ultimately reduce the lead time to product
registration significantly.
Overall, we see this as highly encouraging news for Faron, representing an additional milestone
reached in the development of bexmarilimab
Presentation was very upbeat .
As well as Orphan Status - Markku mentioned some other ongoing regulatory indications that were in the mix which he would let us know about shortly .
Also some very encouraging biomarker data that they are discovering ( lost the detail of that but he was very excited )
Bexmab sites are adding plenty of patients ( I think he said another 15 were enrolled )
Spaces taken up immediately when available .
Asked him about going it 100% solo into P2 . He said that this data has made Bex alot more valuable - so maybe a deal now is not in best interests of shareholders . Maybe P2 data will be needed for a mega deal .
At least he's honest - either way - he says they are VERY busy .
Bexmab update probably October - but I think he said that what they are seeing is ' very' exciting .
Either way , looks like Bexmab is gaining real traction , and it depends on the ' third parties' as to which way they move into P2 .
Mika Kontro will be talking about - Novel macrophage re-programmer bexmarilimab in myeloid malignancies at the Nordic AML meeting in Bergen Norway on Friday .
https://www.uib.no/en/ccbio/164254/nordic-aml-meeting-2023-august-24-25-bergen-%E2%80%93-norway
Not much else in a slow news week . Results presentation next week , hopefully accompanied by some updated patient data perhaps to liven things up .
the california pharma announced the regulatory action monday morning in a brief press release that provided no details of the nature of the fda’s concern.
not a surprise . must be fairly serious however for them to keep halting its use , as the main listed side effect they do tell us is constipation .
well , it sure has been a pain in the **** for them so far .
not wishing bad luck on them , as the end goal for all these companies is to help the patients at the end of the day .
but if it takes one of the biggest competitors out of the race , particularly in the aml area , where faron look to be one of the front runners in this kind of treatment , then surely we stand a better chance of getting picked up .