Faron Pharmaceuticals - Innovative Medical Solutions (Part 1)

I also paid attention to this. Results in April, 4-6 months for that. Funds raised are sufficient until December -25. Covenant limit deducted from that.
Sounds like a plan?

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Such a plan, on the one hand, sounds like the coffers would have to be replenished again :smiling_face_with_tear: if a potential partner manages to delay the drafting of the contract up to the covenants, then one cannot risk them breaking again. On the other hand, if the results continue at the same level, there might even be competition over who gets the deal with Faron.

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That doesn’t directly mean the results automatically point to 4-6 months ahead, does it? It could be that negotiations have been ongoing for a year already, and we’re in a situation where the results of the next reading could finalize the whole thing in just a week.

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They have been ongoing all the time, at least according to the management.They are certainly not starting from scratch.

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Negotiations have been ongoing in one way or another for years. Negotiations are constantly taking place, and the underlying assumption for their work is good Phase 2 results (i.e., the deal would be like this and this, if the results continue as they have so far). And then, when those good results possibly actually materialize soon, it will also trigger the deal. Provided that other details can be agreed upon. And there are plenty of those details. So, I don’t believe that the progress of partner negotiations is directly dependent on the Phase 2 timeline at this point; rather, time is now being spent dealing with the details of something else. Of course, those good results are still needed


Personally, some time ago I was sure that the deal for blood cancers would still materialize before the final Phase 2 reading. I was wrong. If you’re wrong enough times, you’re bound to be right sometimes


Presumably, the focus of negotiations is now mainly on solid tumors. No one can come up with anything to negotiate about blood cancers anymore. Old news already :face_with_hand_over_mouth:

Currently, I believe in one big global deal where the partner licenses all of bex, solid and loose ( :stuck_out_tongue_winking_eye:). With upfront and milestone payments (and their expertise) from the licensing deal, Faron will participate more heavily in the development of solid tumors, and through that, they will be entitled to larger royalties, milestone payments, and whatever else there is. If solid tumors yield good results, then this partner will buy the whole company at the latest. Before that, it would be nice to really blockbuster in blood cancers, so that the value of this company would reach its deserved level #inyourfaceorion. Because this SME entrepreneurship is starting to get a bit tiresome


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I was also wondering how much Faron can tell potential buyers details about the progress of Phase 2 studies, without us small investors receiving any stock exchange announcements about those results or them being fully ready yet. This would be interesting information regarding whether a partnering agreement is possible already before the official Phase 2 results.

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I wouldn’t be surprised at all if a partnership is announced at the same time as the P2 results. Enough negotiations have already taken place that it’s known who is interested and who isn’t. The only problem has been the unwillingness to pay royalties, which I personally find surprising. Just agree on the revenues, after which royalties always increase once those are reached, and of course, that 1 Billion cash in hand :slight_smile:

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Bono from Faron presented at the Carnegie Nordic Healthcare conference on 11.3.

I wonder if one could have accessed the web live stream just by registering on the website? Perhaps one wouldn’t have needed to work at a pharma company or university?

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Others are also starting to wake up to the significance of Clever-1, i.e., Stabilin-1 (STAB1). Here, a clinical observation made in AML and MDS shows that Clever-1 expression leads to poorer outcomes, followed by preclinical experiments based on that finding. A study funded by Chinese researchers, published in the journal of the Japan Cancer Association/Organization. With Aza, Bex was not a real clinical success in AML, but the game is far from lost even there.

”Taken together, our study suggests that STAB1 promotes growth and aggressiveness of AML cells through activating the IKK/NF-ÎșB pathway while also regulating M2 macrophage polarization within the chronic inflammatory environment. Therefore, targeting STAB1 could be a potential therapeutic strategy for treating AML.”

https://onlinelibrary.wiley.com/doi/full/10.1111/cas.70044

IMG_2854

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Interesting article, I’ll have to skim through it. It’s good that STAB1 is starting to get more evidence based on research other than Maija’s. I haven’t read beyond the abstract yet, but this section caught my attention.

“Moreover, we investigated the impact of STAB1 expression in AML cells on macrophage differentiation and found that co-culture of macrophages with conditioned medium from STAB1-knockdown AML cells reduced M2 polarization of macrophages.”

So, just the conditioned medium from AML cells causes that difference. This suggests that the soluble Clever-1 secreted by AML cells would thus affect the M2 polarization of macrophages.

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So, the Phase 2 results are confirmed for June. Or perhaps this was already announced earlier.

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Are there now multiple phase 2 studies ongoing, or is there a risk of mixing up the second phases here? Isn’t Bexmar’s phase 2 stage going to be announced next month, however?

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It seems that next month we will get a summary of the results, and then in June a more comprehensive overview.

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Right, this is from the last bulletin in January, which Bono’s comment clarified a bit.

“Faron Pharmaceuticals Ltd. (AIM: FARN, First North: FARON), a clinical-stage biopharmaceutical company focused on tackling cancers via novel immunotherapies, today announces that, the final patient has been identified for the BEXMAB Phase II dose optimization study in refractory or relapsed myelodysplastic syndrome (r/r MDS), as well as the BEXMAB Phase I/II study in frontline high risk (HR) MDS. The topline response rate read out is thus expected to become available in April 2025. Detailed data will be presented later at upcoming major medical conferences.”

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image

https://academic.oup.com/jnci/advance-article/doi/10.1093/jnci/djaf013/8029621?login=false

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That 20% was a figure when off-label use was also taken into account.

In other words, over 80% of patients in phase 2 studies receive a drug that the FDA ultimately does not approve (or that never progresses beyond phase 2). The most common reasons for this are safety or lack of efficacy.

So, over 80% of patients participating in trials receive useless or harmful treatment.

The investigator physicians at the centers have great power in which studies patients are directed to, and that choice can be a matter of life and death for some. Physicians presumably primarily want the best for their patients. Secondary is conducting science.

This brings us to Faron and bexmab. If recruitment proceeds slower than planned, it may signal that the physicians at the centers prefer other studies in which they see more potential. For example, MD Anderson currently lists 36 active studies with the keyword MDS.

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I think you are making quite big assumptions about the potential of Faron and Bexmap in your message.

Slow recruitment can also be due to, among other things, patient selection possibilities and criteria. Patients may have restrictions or criteria that make them ineligible for studies related to Faron and bexmap. For example, if the study’s inclusion criteria are stricter (e.g., a specific genetic profile or requirements for previous treatments), this can limit the number of patients and slow down recruitment.

The number of patients can also be affected by regional or resource limitations, as these also influence how quickly patients can access the study. Additionally, communication and marketing play a role. If there isn’t sufficient awareness of the study among doctors or patients, recruitment can be slow. If doctors are not aware of the study’s existence or its potential, they will not refer their patients specifically to that study.

Finally, I would add that even though studies are scientific, doctors’ personal preferences and experiences can influence study choices. Therefore, slow recruitment should not lead to assumptions that Faron’s Bexmap potential is not strong.

We will only hear about Bexmap’s potential next month, how strong it is, and until then, we will have to wait in suspense. No wonder there’s a buzz around Faron’s stock, as last Friday’s rise of well over 5% and over a million in trading clearly showed.

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I would also add to this that

What country’s product would an American doctor choose for an American patient in an American hospital? A typical American patient would hardly choose any Finnish jab carrying a communist chip if domestic alternatives are also available on the list. So I’ll elaborate on that a bit, that as a Finnish company, the path to travel is much rockier than for American competitors.

But otherwise, I didn’t delve much into that post, but the general feeling is more in line with Clark’s message —> it tells how few ultimately succeed. However, in such news-poor times, even the smallest news always warms one up a bit.

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How many others where patients are recruited for whom everything possible has failed?

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Usually @Clark_kent brings quite valid perspectives to the discussion. I haven’t personally compared the mentioned 36 studies, so I can’t say what is a slow or fast recruitment pace.

Perhaps @Clark_kent could elaborate a bit more on the comparison you made between bex vs. the other 36, so the rest of us can understand better.

My understanding is that it’s more the rule than the exception for studies/recruitments to be delayed.

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