Member Info for Saxondale

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.

She was poached by Bayer from GSK .

So why would she accept or want to be on the board of a small little known Finnish company ?

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.

Yep me too . Average into the 6's again which at least is one positive for me lol .

When this finally does turn , at least I can look back and say I made the most of the opportunity .

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 .

Great news indeed and thanks for sharing . I was wondering why the Naz was up .

Another box ticked for the team .

Should be a very positive meeting tomorrow .

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 .

Gilead acquired magrolimab as part of its $4.9 billion acquisition of Forty Seven back in 2020.

Someone should have told them they could have had Faron for $1 billion back then .

If Bexmab data continues as it has , maybe we can command a $4.9 billion price tag .

Approx £62 a share ( a 22 bagger from here ) . That would be nice lol

It will be refreshing to have a drug like Bex out on the market , that not only does what people want , but also doesn't come a with a 10ft long list of side effects and hazardous consequences .

Some update due shortly I reckon .

I guess the price tag goes up the further you can stretch it down the clinical trials .

The Bexmab data has been a massive bonus for them - proving what Bex can do in combi settings.

And if Bexmab gets some kind of accelerated approval for the AML/MDS market - then they have their foot in the door .

But its taken many years for them to get Bex into a proper package to actually sell/partner with .

Dosing/soluble Clever1/biomarkers/manufacturing/ diagnostics have all had to have been sorted .

Luckily , they've now done that , and now investors can look forward to reaping the rewards .

So making it this far and still being 100% wholly owned is big .

Always a hard one to know when to take profit .

This one has accelerated very quickly for me .

Added today , but happily still showing a healthy profit .

Not sold anything , and I'm still reading up on the company as best I can .

The amount I have in here won't keep me awake at night - and I'm not a very good trader , so will see where this runs .

Sometimes , being lazy and leaving your funds in the stock can be the most profitable way to proceed .

Happened with NCYT ,GGP and EUA for me . Ok , they all peaked and took a dive eventually , but a lot further down the road than many predicted .

At Mcap 50m , we haven't entered the hype zone yet , so happy to see the swings , add when I can , and see what Chris does when he takes the helm .

Https://wsw.com/webcast/canaccord89/farn.l/2742223

Nice little update - Markku and MLF are in US in person .

No new data - but from the talk they are having very busy ongoing talks with potential partners at the moment ( as always lol) , but highlighted how Bex is wholly owned , opening new sites shortly in US ( Yale UFC and Fred Hutch) .

Orphan Status has been applied for and expect FDA response in next couple of weeks .

ASH abstact is next goal - new patient efficacy data will be presented by then also , as more patients are on the study already .

When asked about who else is working on Clever1 - Marku says that we have no direct competitors . Well protected by patents until 2037 , and although they are the ' new kids on the block ' , they are expanding in US .

Looking to be Nasdaq ready - as US and hence the Boston office is very important for the future .

So just a quick chat really - but you get the impression that they will be having plenty of meetings .

Mcap is still around £50m .

Having followed pharma shares for years ,progress can be solid , but glacial in speed .

Then all of a sudden you get massive movements that no chart could predict .

I think if something positive is coming , the size of the company at present could change dramatically .

Its just an automated simple system - doesn't really tell a true story as spreads can send it off course so it isn't worth looking at really . If you are getting live quotes at the same time then you can get better idea , but many big ones are delayed so you never really know what time they happened.

Either way , it's looking good here . Added again last week .

Been reading up about this new CEO . Sure does instill alot of confidence as to where this company may be heading .

I managed to watch it this morning on youtube .

He gets better every time - so much achieved in a small space of time .

Alos noted that he had a slide for those new Rio farm in tenements and how his geologists were very pleased to be out there .