Member Info for Saxondale

Must be a lot going on behind the scenes .
New big hitting CFO James O'Brian joins , with major M&A pharma experience.
New BOD member Tuomo Patsi joins - also with huge experience in that field .

Both have close connections with Bristol Myers Squibb in their past , who in my mind is the front-runner to take the reins of Bex in the AML arena .

New US sites all arranged for Bexmab ( months ago ) .
Data coming out has been top drawer - couldn't ask for better .

So why the delay ? We may soon find out IMO .

Having said that , I've only been here 3 years . It just feels like 4 .

Exactly - I'm about even at the moment . I didn't wait 4 years to just get my money back .
The funs only just about to start , and I intend on making the most of it .

He looks like a perfect fit for their plans , be it funding for trials , or licensing deals , right through to multi billion sales .
A guy of that calibre would not join Faron at this crucial moment , if they weren't pretty sure that the company is going up the ladder .
Little top up myself this morning on the back of this major breadcrumb .

Faron setting sights on the big time .
Good bye Toni , he did an excellent job getting the company this far - and his EIC funding achievement etc.
Good luck with your next job .
New guy looks to be the right fit for where Faron are heading .

From his bio -
As a CFO with extensive experience in large and multi-national public and entrepreneurial privately held companies in the life sciences, biotechnology, and pharmaceutical industries, I bring financial discipline and rigor to the entire R&D, commercialization, and go-to-market strategy product lifecycle associated with launching new therapeutics.

My expertise across the pharma/life sciences financing spectrum includes equity fundraising and debt raising. I have managed company valuations, led multibillion-dollar acquisitions and licensing due diligence, been an integral part of investor relations and board finance reporting, and developed competitive analysis and benchmarking models.

Throughout my career, I have been charged with managing capital allocation and forecasting; I understand the key cost drivers of the business from early stage development through productization and am well-versed in analyzing market penetration, synthesizing NPV, and creating pricing models.

Currently, as the CFO of Cognition Therapeutics (NASDAQ:CGTX), I created the financing strategy to support the launch of the company’s core therapeutic. We completed an IPO raising $52 million in 2021 that will enable us to complete clinical trials on CT1812, a small molecule with disease modifying properties for Alzheimer’s disease, Parkinson’s disease, ALS, and AMD. I am now developing the financial strategy and controls to scale to a multi-platform company and analyzing ways to optimize resources and talent to launch additional trials.

The guy has some impressive credentials .
Lets hope he can help get Bex to market ASAP .
They have a big team in place now - AGM passed a big increase in options available too . Management want to be rewarded for whats coming . Understandable , but lets hope we see some action now in the next few months .

One benefit of having spent years building up for the Traumakine launch , and subsequent nose dive , is that they have had a full dress rehearsal . With Bex , they have had the benefit of knowing exactly what potholes to look out for - be it trial protocols , funding exposure , IP etc .
And Traumakine is still there - lets hope they finally get that phoenix out of the ashes this year too .

Look what just popped up on Farons twitter page -

They have been noted as a case study for a small Pharma company - as to the correct way to make sure you are doing the right thing to get regulatory approval .
So Faron have been making sure they tick all the boxes along the way - so they are 'match fit ' so to speak , should they get promoted .
Many small pharmaceutical companies find that they lack the resources, knowledge and expertise of the regulatory landscape for adequate vendor management in clinical trials, making the organization vulnerable. Recent research suggests that some pharmaceutical companies have found themselves out of compliance with ICH, FDA or EMA guidelines. This paper aims to perform a comprehensive review of the regulatory landscape for vendor selection, oversight and ongoing evaluation in clinical trials. In addition, the case study performed studies the practices recently implemented at small pharmaceutical company Faron Pharmaceuticals to assess regulatory compliance and identify any potential best practices. Faron Pharmaceuticals conducted a process improvement activity at the beginning of 2022 to improve the vendor selection, oversight and evaluation of their clinical trial partners. The results of this case study indicate that Faron Pharmaceuticals’ processes are regulatory compliant, suggesting that QTLs, KPIs, SOPs and communication plans are effective vendor oversight mechanisms for small pharmaceutical companies to utilize.

Mcap is at a nice round £200m at the moment , which makes price targets nice and simple .

Markku believes the company is in pole position in their sector of the cancer immunotherapy world .

They have spent 10+ years getting to this point and invested huge amounts , along with getting multi million grants and funding packages.

The share in issue have doubled approx in last 4-5 years . Understandable , but luckily most have gone to II's and sticky holders .

We have 3 drug candidates , that partnerships could be arranged for , although one in particular has taken centre stage .

We already have partners in the form of the EIC , LLS , along with others , all who will benefit if Faron succeed .

Multiple trial possibilities . Not limited to one cancer type
USA becoming a key element of growth plan .
New hirings specifically focused on bringing a product to market .

So if a P2 trial stage company with a successful drug candidate is worth approx $2 billion

Then give or take , that leaves us with a £25 share price on acquisition .

Not going to happen tomorrow , but the reality is - Faron have that kind of package .

Peel Hunt still have FARON as a buy - £5.24 based on todays news .

Odd however , as they had the same price back in Oct 2022 - before Bexmab data even emerged .

Rather lazy for our own appointed Broker not to do a little re calculating .

Maybe they should earn their money and get some up to date information rather than churning out an old figure .

https://www.proactiveinvestors.co.uk/companies/news/1009913/faron-pharma-plenty-of-upside-says-broker-1009913.html

https://www.proactiveinvestors.co.uk/companies/news/995720/faron-pharma-gets-reiterated-buy-rating-from-peel-hunt-following-bexmarilimab-therapy-news-995720.html

Article here about the oncology market and when deals are done .
https://www.nature.com/articles/d43747-023-00002-6

Interesting that many deals are done even pre clinical ( due to being still somewhat risky ) - and even being a bit cheaper than a Phase 1 deal , approx $0.4 -0.5 billion
But once you get to a Phase 2 stage - and you have established the dosing toxicity , the early signs of efficacy , and validated biomarkers - the price point goes up massively .
Deals done at P2 stage average approx $2billion .
25% of aquisitions are done at this stage , but only 10% of licensing deals .

But Bex is probably not that average - in as much as it has many possible licensing options for many different cancer types , so there are many routes to market .

Markku and team must have some deals / offers on the table at the moment to choose from , now the road is open to proceed to further trials .

Huge competition out there to secure future profits for these Big Pharma .

And Bex is in a very lucrative market , and with a very unique selling point .

From the original IPF RNS . Since then , there has been an ammendment , but Faron mentioned that after the FDA meeting they would immediately bediscussing matters with IPF .
They still meet all the criteria - It's just is there a better offer coming - rather than commit yourself to more borrowing ?
RNS -
The second tranche of EUR 5 million may be drawn down on or before June 30, 2023 if Faron raises at least EUR 15 million of new gross equity, has sufficient funding until March 31, 2023 and has received an approval from the Food and Drug Administration of the U.S. Department of Health and Human Services regarding the protocol for a pivotal clinical trial of bexmarilimab in an oncology indication. The third, yet uncommitted tranche of up to EUR 15 million could be utilized after the drawdown of tranche two, subject to the IPF investment committee's prior approval on or before June 30, 2023.

And Swiss Bio next week in Zurich .
Swiss Nordic Bio is a high-level partnering and investor conference aimed at connecting healthcare innovations, investor and industry. The conference is the number one platform that gathers life science professionals from Switzerland and the Nordic countries under one roof.

Also good timing of this announcement whilst they are at BIO Europe 2023 Partnering conference in Switzerland .
https://informaconnect.com/bioeurope-spring/

One IPF stipulation for the next funding was approval for P3 trials , along with having a certain amount of cash on hand .
Both of which they have now
So yes , I think this may unlock access to that money .

Don't forget Bexmab also - which could still be the quickest route to market for Bex .

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 .

Wish I'd bought more last week at 18p when I jumped back in . But I remember buying at 30p and 50p in the past , so like others have said , this is just rising back to something sensible now .

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