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Nice summary of the publication in the Lancet, already found on here yesterday, of the data on phase 1, showing important utility in AML as well as in MDS.

Furthermore, treatment related adverse events were mild to moderate with only 6% attributed to Bex and no dose limiting toxicities- a fine safety and tolerability profile.

Est Median overall survival was 13.4 months in patients with HMA-failed MDS and 8.1 months in patients with r/r AML.

As we are all familiar, 13.4 months is largely believed to be much greater than double survival of no further options.

With respect to AML, 8.1 months can be considered in the context of the below, so i would argue a 50% increase in survival depending on previous treatment pathway, and up to 3x as I believe we were told by Juho that we showed utility after AZA & Ven.

Median overall survival of approximately 5.3 months for patients with R/R AML.

After Hypomethylating Agent (HMA) and Venetoclax Failure: Patients who relapse after HMA/Venetoclax therapy have a particularly poor prognosis, with a median overall survival of only 2.4 months.

Other important elements of the published data:

This clearly demonstrates we are acting on the Bone marrow and increasing that all important HLA-DR which allows for the malignancy to be visible to the immune system & activates natural killer and T cells to utilise our bodies own defense mechanisms, ‘uncloaking’ the cancers immune evasion properties…

If we consider this to be the case in 67% of MDS cases, this adds to

The high utility in this treatment population which could be refined further with precision oncology tools such as companion diagnostics to really hone in on those most likely to respond.

A real tasty appetiser for today’s big release, showing utility in MDS and AML, a timely reminder on the size and broad utility of the prize…

Plus, the Nasdaq Helsinki reopens today….

Let’s frikkin gooooo!

Arguably the biggest day to date in the companies history.

Not expecting anything major this morning due to the full data package being unveiled at the conference and the market probably being closed during presentation, could be some last buys for those aware of what we have here, especially when consider at €3 we are considered 75% undervalued wrt their price target and valuation methodology. ( nice find Wolfi).

Let’s go, good luck all!!! BOOOOOM!!!!’

Nice bump up to €3.09 on the Nas….

Boooooom!

Sure, just as soon as you have qualified this one:

Any income stream Faron may get from Bex is 4-5 years away- this is the time scale to get through Phase 11, get approval for phase 111, get funded by whatever means possible , run phase 111 and finally get approval and then launch. Realistically the best we can hope for , medium term as investors ( everyone’s definition of this is different )is a partner to come in which will hopefully push the SP up. Then its decision time- wait for further developments or take profits - whichever way you cut it, its going to take years,-unless phase 11 is absolutely stunning- then a buyout may happen but I doubt it. Meanwhile Faron have a ton of money to raise.

May I suggest you leave and reflect on what you have been telling others, which is baseless nonesense, wether you have spent your life working on the bins or on Wall Street.

I have given rational and relevant arguments to back up my posts, I cannot help if other don’t understand the process by which drugs are approved and if they have benefit over existing standard of care.

The fact your tone has gone from one of over confidence to suggesting I leave speaks volumes.

I’ll leave if I choose, or am evicted. I have respect for all but will not respect those who disrespect me and my views, especially those who have little understanding and / or respect for others, not will I qualify my posts to those asking while offering nothing of any value.

By your understanding if a treatment doesn’t kill you stone dead it must be an improvement.

Strewth, I would give you the BOTD but your posts on here previously have been naive and ill informed…

Not really as it isn’t compared to existing standard of care. It means nothing as a stand alone measure…

This was what was concluded by the FDA:

As of early 2024, Gilead has ceased development of magrolimab in hematologic cancers. Enrollment in solid tumor trials has been paused, and the FDA has placed these studies on partial clinical hold while Gilead reviews the benefit-risk profile of magrolimab across all ongoing trials .  

In summary, magrolimab did not show a survival benefit over existing therapies and was associated with increased mortality in several trials, leading to its discontinuation in hematologic malignancies.

There is no other treatment options following AZA in r/r MDS!!!!!

Hope that helps….

Dystopian. There is no survival data in the link you published, there is a big difference between survival and response data, furthermore this is in a very small sub set of AML ie TP53 mutations.

By contrast, Bexmab is an all-comer r/r MDS trail, and also as agreed by the FDA incorporates FL patients to facilitate expedited approval as is the case with project front runner, where as Juho stated, the trial is not expected to be much larger than the phase 2, and allows for an accelerated approval pathway in both indications.

This is low hanging fruit in both lines (r/r & FL) with the pathway all but confirmed which comes this summer.

I don’t think you understand how close to death r/r MDS patients are, and the results we are seeing are very easy to ascertain over and above no other existing options.

FortySeven’s data set showed that Magrolimab was actually shortening life span when the survival data was actually published. I hope that helps…

Lol, your contributions won’t be missed by me…

*Next generation

Farons RR data was recently given for the P2 data which was reported using IWG2023 standards / criteria, previously it had been reported using the prior IWG standards criteria.

Given the more stringent nature of the newer reporting guidelines, there likely has been little / no drop off in efficacy just a change to reporting standards which no longer incorporate weaker HI improvements and other less accurate measures.

Bex data is everything it was already cracked up to be and the perpetual data coming from the company wrt who will benefit and why only strengthen the investment case for Bex as a true immune activating immunotherapy. One which can work alongside others and with a superb safety profile.

It is the next gratin macrophage reprogramming treatment big pharma have been waiting for with some synergies currently more clear than others…

You miss the keypoint.

They moved for FortySeven before there was survival data which is the key determinant as to whether a drug will be approved. Faron have already almost 3x’d this and will likely see this go up as is the way in which PFS is calculated.

Therefore it is massively derisked as to where FortySeven was which was purchased on response rates, ie blasts improvements. It’s all good killing everything in the BM but if your safety is poor and you are killing the patient, it is no good for survival- Faron ticks all boxes to the contrary…

Howard,

If previous precedent ie Gileads Forty Seven acquisition (4.9Bn) WITHOUT improved crucial survival data, which Faron already have and will be the definitive factor in approvals, or the other examples I have provided coupled with a highly competitive IO market with mega players looking to plug patent cliffs / consolidate existing market share via unquestionable synergies ie ( improving efficacy and resensitising to Venetoclax ) thus improving and expanding existing market share in highly lucrative IO / Hemo indications isn’t relevant then I’m not sure what is!?!?

Do you even bother reading what I’m writing.

I couldn’t give a fudge about your qualification of what may or may not be relevant, but at least come back at me with an alternatively plausible outcomes on the topic being discussed, otherwise it’s just pointless piffle on your part….

You can also throw Roche in there if Abbvie are not willing to act as co-developers of Venetoclax in Hemo.

Exciting 2025 coming up and u suspect we are owned by another by 2026.

Relax and enjoy the journey…

A fair chance we can get around the Gilead / Forty Seven acquisition price ($4.9B) for blood cancers as a package in my opinion, and retain the rights to solid tumours team up with the likes of Merck….

Our results show that CLEVER-1 is not only a macrophage checkpoint but also expressed on malignant myeloid cells and targeting it with bexmarilimab can enhance antigen presentation and sensitize these cells to standard therapies. These findings highlight a compelling opportunity to integrate bexmarilimab into standard treatment regimens for AML and MDS,” said Dr. Maija Hollmén, Chief Scientific Officer of Faron and senior author of the study, MediCity Research Laboratory and InFLAMES Flagship, University of Turku, Turku, Finland.

Using ex vivo models, the team evaluated the effects of bexmarilimab, alone and in combination with standard-of-care therapies azacitidine and venetoclax, on immune activation and cell viability. Bexmarilimab monotherapy increased the expression of antigen-presenting HLA-DR by 1.2- to 2-fold in up to 66% of patient samples, especially in those with low baseline expression and high CLEVER-1 levels, without any cytotoxic effects on the blast cells, via potentially inducing interferon gamma (IFNg). Addition of bexmarilimab helped overcome venetoclax-resistance in 33–40% of ex vivo AML samples, without adding to lymphocyte toxicity. Moreover, the triplet of bexmarilimab, azacitidine, and venetoclax showed enhanced cytotoxicity in ex vivo models of treatment-resistant AML; suggesting that bexmarilimab increases the susceptibility to venetoclax and/or azacitidine induced cell death.

Abbvie are coming for us!!!!

But we also have fall back competitors likely to drive up the price such as BMS, Merck and potentially Pfizer…

AbbVie paid $5.8B for ImmuVen Bio (preclinical) and $21B for Pharmacyclics for blood cancer IP, showing willingness to act early on mechanistic data.

And he knows exactly what it’s worth in MDS alone having done the market research segment at Capital Markets day.

I find it quite remarkable we haven’t already been swallowed up given the open goal Bex presents in r/r MDS & the size of that indication alone at $300k per year, per patient….

$$$$

I asked ChatGPT: What is likely the market potential here if it works in both solid tumours and IO therapies via this mechanism and what would be the likely acquisition price?

The below is the first paragraph:

If (Bex) proves effective across both hematologic cancers (like MDS/AML) and solid tumors, especially as a macrophage reprogramming backbone for IO combinations, its market potential could be enormous — on the order of $5B–$15B+ peak annual sales.

Let’s break this down logically:

And below is the final paragraph or Summary:

Bex’s macrophage reprogramming offers foundational immuno-oncology synergy.

• If it enables checkpoint inhibitors + ADCs broadly:

• It could rival or exceed the value of Keytruda, Enhertu, or Adcetris.

• A full validation in both hematology and solid tumors would command a $15B–$30B+ valuation.

• Even today, with MDS data alone, a buyout in the $2–$6B range is credible if competitive interest heats up.

2/2

or we can sell the rights to blood cancers & co develop solid tumours indications with the likes of Merck & other major IO players.

However I suspect an offer for the whole company that we cannot refuse will win the day, with some of the biggest IO players in the industry, such as Merck, BMS, Roche-Genentech, Novartis, Pfizer, JnJ, AZ, Gilead & Abbvie eager to get their hands on this ultra-versatile, broad application, complementary, cell reprogramming, modern immunotherapy candidate! (Yes, I am clearly excited and emphatic about where we are heading).

All of which have significant synergies be it in their own IO therapies in solid tumours and / or blood cancers and owners of the likes of Azacitdine which is the case with BMS following their acquisition of Celgene, or owner of Venetoclax, a drug owned by Abbvie & likely to be displaced by Bexmarilimab via its superior safety and efficacy profile.

I

So many options available to Faron, and at its current market cap, it’s never been such a steal as we enter the deal making stage, which should light the touch paper and send us to a destination far and away above our current dwellings.

Always DYOR. GLA…

Superb.

A stunning and now published and peer-reviewed revelation:

Blocking CLEVER-1 enhances anti-PD-1 immunotherapy, offering a promising approach to overcome treatment resistance. This blockade effectively increases the sensitivity of macrophages to bexmarilimab-induced reprogramming, significantly influenced by the tumor microenvironment. This breakthrough suggests a novel way to improve the effectiveness of existing cancer treatments and potentially improve patient outcomes. Stay tuned for more updates on our advancements in immunotherapy!

Dr. Maija Hollmén, Chief Scientific Officer of Faron Pharmaceuticals and senior author of the study from MediCity Research Laboratory and InFLAMES Flagship, University of Turku, Finland, said, “This work gives us a mechanistic framework for understanding why some patients respond remarkably well to bexmarilimab while others do not in solid tumors. By recognizing that macrophage response is governed by the tissue’s immunological state, we open new possibilities for tailored therapy. This could help guide both clinical trial design and eventual treatment decisions, ensuring patients are matched with the right therapy to have a better chance at survival.”

The synergies here for existing PD-L1’s players / IO’s such as Merck’s Keytruda are undeniable, not only will this allow for additional clever-1 positive tumours to be treated- just think ‘cold’ tumours, which are far more prevalent than ‘hot’ tumours, offers a massive total addressable market uplift;

but ALSO re-sensitising ‘hot’ tumours which have cemented Keytruda and Merck its position in oncology given the size of the solid tumour market and its rights over the worlds top revenue grossing drug extending overall survival in many indications;

Which by the way have come under threat not only from an IP and patent perspective, as the Keytruda patent expires in 2026, opening the door to generic competitors, but also from the likes of IP protected competitors such as Summit therapeutics & their dual targeting IO therapy ‘Iovinescimab ’which recently blew Keytruda out of the water on survival, in their own back yard of NSCLC in their landmark HARMONi-2 trial, an indication nobody could come close to matching beforehand.

If Faron can do a mega Deal in solid tumours with the likes of Merck, who I suspect will be chomping at the bit to regain control of its solid tumour IO empire, whilst simultaneously extending its highly lucrative Keytruda patent through a combination approach, which is the mechanism of dual targeting Ivonescimab, then it very likely gives them back their edge in the biggest solid tumour market on the planet, which I’m quite certain they will be willing to pay mega bio-bucks to achieve.

This would enable Faron to solely develop Bex in, firstly r/r MDS then in the FL population, which would rapidly become a cash cow;