Bexmab had a built-in possibility to expand the studies into selected indications, which included first-line MDS. So, there was no problem from a technical perspective.
R/R MDS was chosen because the understanding was that approval for this indication could be sought based on Bexmab. This was the “low-hanging fruit” that actually turned out to be a dead end.
Faron plans to approach the FDA regarding the Phase 2b results, and as we just heard, CR (Complete Response) and its duration are what they are aiming for. One study on the subject; from the portal, click Julie under Zeidan’s Bex presentation—it’s part of that ASH package that caused the “Tänka På” (Food for Thought).
https://www.vjhemonc.com/event/post-ash-2025-mds-highlights/
”Durability of complete response outperforms complete response rates as a surrogate endpoint for advancing to phase III trials in high-risk myelodysplastic syndromes”
Julie Braish University of Texas MD Anderson Cancer Center, Houston, TX, United States
A study conducted at the Moffitt Cancer Center, retrospective (data collected after treatment), 980 HR-MDS patients (intermediate and higher risk).
An investigation into why success in Phase 1/2 does not translate to Phase 3, which is the “hottest” topic right now, as we know… TP53 is particularly problematic. CR is seen there, but it’s short-lived.
Hypothesis: CR with a duration of 6 months or more predicts survival benefit (OS) better than a one-time CR response.
Those undergoing bone marrow transplants were not included in the analysis. (Transplants must be handled in the plan so that they don’t penalize Bex if the CR duration is cut short by a desired transplant, ed. note.)
They showed that the longer the CR, the longer the survival (pretty obvious). CR itself also works. In their opinion, CR duration of 6 months or more could be considered a surrogate—an indicator predicting survival benefit (the kind that, if approved by the FDA, could lead to AA [Accelerated Approval] marketing authorization, ed. note). CR has already been such an endpoint. What will be enough for the FDA next year is not known; the guidance only uses the word ”meaningful”.
What does Faron say about those response durations?
business update | February 11, 2026 Faron Pharmaceuticals - Innovatiivisia lääketieteen ratkaisuja (Osa 2) - #3416 käyttäjältä Vino_Pino :
”Follow-up is still immature (as I understand, it was the November reading, ed. note), but the median duration of CR is already over 12 months, and follow-up continues – potentially it will still rise. In TP53-mutated patients, the CR rate was an amazing 70 percent, and the duration of CR was over 10 months, possibly still rising. Historically, this patient group usually lives 8–10 months.”
Looking at those figures, it seems we are starting to be in the safe zone. New numbers likely in a month at BSH. A median of over 12 months means that for at least half of the patients, responses have lasted over 12 months. In the Moffitt study, the 6-month limit is instead the minimum response duration that everyone should exceed.
It could be that “easy” patients are “always” selected for Phase 1/2a, and the truth and reality only emerge in randomized trials. Now it might be the other way around, if/when TP53 patients have been selected more than their natural proportion would be. If preliminary observations that cytopenias occur less with Bex than without hold true, the problems experienced in Phase 3 may partly turn to Bex’s advantage, as there are no dangerous deficiencies like with many other toxic drugs. Well, Phase 2b/3 will eventually show how it goes.
At least “how many cycles” of aza (azacitidine) were received will also be controlled as a factor. Indications of future Phase 2b success can be obtained if these CR-duration surrogates are scrutinized.
Studying R/R (relapsed/refractory) patients finally opened a completely new path forward, the continuation of City of Hope, the IIT (Investigator-Initiated Trial)—we’ll see what kind of support it needs from Phase 2b or what they think about communication with the regulator there 
I’ll ask some basic-level questions again.
There is probably enough evidence for Bexmax by now that it doesn’t cause unpleasant side effects. At least not strong or significant ones. There just isn’t enough evidence yet of Bexmax’s efficacy in cancer treatment.
Then the stupid question: Shops are full of all sorts of natural remedy “gunk.” Even harmful ones. Bexmax is going through drug approval processes, but shouldn’t its sale actually be allowed on the same level as natural products? No side effects, so “take it if you like,” as long as you follow the maximum dosage instructions. Of course, the administration of Bex is directly into the bloodstream and more controlled under supervised conditions, but still.
And if the classification was initially in the “natural product” or “OTC (Burana)” category, can the classification be changed as more research results come in? Or can it affect the pricing, where the price of the initial freer sales would have to be lower (though it’s expensive enough that even then only the wealthiest could afford it).
Just a thought for getting at least some kind of positive cash flow started.
If a product has a medicinal effect, it is classified as a medicine. Selling it as a natural health product would constitute illegal trade in medicines, leading to immediate sales bans and criminal charges.
And in addition to the above,
Bex does, however, have an activating effect on the immune system and has proven adverse effects, fortunately, as evidence that it is working. So we’re not talking about natural product-level side effects. The risk is that reckless use, for example in active autoimmune disease, would cause serious harm. The reputation could be ruined. However, the risk/reward ratio of harms and benefits has seemed good compared to other molecules. Additionally, at this stage, production must be cost-optimized to be predictable, such as for the starting trials.
One way to get it into use before approval could be compassionate use Compassionate medicine schemes help patients with cancer live better and for longer — why are they not more widely used? - The Pharmaceutical Journal. In that case, the doctor has to request permission separately for each patient, so very significant revenue could not be expected.
It seems the only way to get it into use and testing right now are these trials, which will soon start for r/r MDS, AML after transplant, breast cancer, melanoma, sarcoma, lung cancer, and that HR-MDS. Faron communicated that there would be more willing users, but they cannot take them.
Hi, I tried to interpret yesterday’s Faron presentation and whether it’s worth participating in the offering. So is the situation such that after the offering, the next Phase IIB results won’t be available until the autumn of '27? So are we waiting 18 months for the next big news? I understood that there were some investigator-initiated trials underway at the same time, but the hard data for the Phase III transition will come in about 1.5 years?
CK-The above concern raised conflates data immaturity with statistical bias. Kaplan–Meier methodology appropriately handles censoring, including transplant censoring, which is necessary to isolate drug-specific durability. A “median not reached” outcome indicates that fewer than half of patients have progressed, typically a favourable early signal. The wide confidence intervals reflect limited events, not inflation. Additional patient-level visualisation would improve interpretability, but the core analysis is consistent with standard oncology reporting.
I had to double-check because the ASH presentation data was actually objective response data. Where exactly is this CR duration data?
Apparently, the corporate deck’s 12.1 months (8.1 months - NR), with no N number mentioned, and the business update’s “over 12 months” with no other information, are the only things known about this. The data is apparently from 11/2025.
Interview with Joab Williamson of Faron
Joab sheds light on what happened during the discussions with the FDA over the course of 2 years. Fortunately, a path to accelerated marketing authorization was finally shown.
If Joab had said that the FDA officials started singing this, I wouldn’t have believed it, I have to be a bit bearish for a moment:
You’re just too good to be true
Can’t take my eyes off of you… 
But, as Juho also seems to have communicated, the data looks incredibly good, but it still has to be proven in a randomized trial. From the FDA, the aforementioned suggestion is very believable: “if you think there is efficacy, you’re crazy if you don’t do it in the first line; you can get approval for R/R at the same time.” Now City of Hope is also stepping on the gas in R/R, in addition to the above.
That is correct; results will likely not be available until late autumn 2027.
When asked about the most important milestones the company will deliver over the next 18 months, Bono replied:
Naturally, the most important news is the publication of the BEXMAB2 study results in late autumn 2027.
The company has previously issued a press release for events like point 1. The status of point 2 is likely more of an internal company matter, but it can be inquired about at the spring 2027 Annual General Meeting at the latest. The start of the studies in point 3 is still awaiting regulatory decisions, but it is possible that approval will be granted during the first half of 2026.
A press release may also be issued then, providing an estimate of the start date.
Ph2b is already randomized, which as I understand it can be used to obtain marketing authorization for r/r patients. (Correct me if I’m wrong) There are 4 or 5 investigator-initiated trials starting in solid tumors. And that stock crash is due to the fact that you can subscribe at a price of €0.50 in the rights issue. Personally, I’m in it with the mindset that the company’s value will return to around €200M over time.
I always find myself pondering Bex’s effect on reducing Aza’s side effects. If it worked the same way with other drugs too, couldn’t Bex become a drug for that indication alone? It wouldn’t necessarily even need to affect the cancer in any way. It would function like, for example, stomach protectors combined with anti-inflammatory drugs. Would that require starting new clinical trial phases for that indication, or would some kind of shortcut be possible?
From what I’ve understood, at least from Juho’s comments, BEX opens those “locks” for the body’s own mechanisms against cancer, as well as for AZA and potentially other cancer drugs. And if, on top of that, the side effects of various drugs are reduced, it really sounds too good to be true. But it is entirely possible because without new perspectives, we’d just be running in place, and new ideas aren’t exclusively born in large companies or research institutions.
In my understanding, the recent Faron hype, from which we are recovering and which is being revived to offset losses, is due to three factors:
A) Over 90% of shareholders do not understand oncology, drug development, or the massive investment risk associated with this type of investment.
B) In the absence of their own understanding, this forum, analyst coverage, and JUHO’S speeches create a collective faith and trust that helps them forget point A).
C) The majority of investors likely cling to averaging down their purchase price and ignore points A) and B). The consequence is that the Euro-denominated risk position increases even further, while Faron’s risk of failure remains constant (at least until mid-2027).
As a lesson from the past, FARON is FORCED, due to its position (and having only a single molecule), to paint a shortcut to paradise for you and me. Juho’s speeches (as we have hopefully learned) should be taken with a healthy dose of salt and pepper – and even then, one must be cautious. Finally, as my own view, I state that I don’t even believe in a break-even outcome for myself (I don’t have €0.5 shares). My own goal is to minimize losses and accept that after this and future mega-dilutions, the only winners will be those participating in the final rush. These, too, only on the condition that the company doesn’t collapse. However, the current situation is not (yet) that final rush.
Vesa Karvonen (Pacta sunt servanda Oy – it means: “Agreements must be kept”) subscribed for 72,000 shares.
Yrjö Wichmann bought 10,000 shares from the market.
Juho Jalkanen subscribed for 23,656 shares for himself and 4,860 shares for a person closely associated with him.
Personally, I see that with the success of the share issue, Faron now faces no risk of failure before the Bexmax2 readout around 11/27. Only potential positive drivers in between.
The investment case is risky, as startups/biotech usually are, but the stock market is a gamble and I’m not interested in trades of a few percent, so I’m going with the risk all the way to the end here.
Even if one knows nothing about oncology or whatever field Bex belongs to, my decision to invest is at least based on a gut feeling about whether this will become a drug or not. There are many variables, such as faith in the team leading this (Bono, Maija, etc.) and feedback heard from the field. Medicine is absolute Greek to me, so I’m relying on these third-party accounts—on faith, in other words.
In practice, it’s about whether it gets FDA approval or not. My own estimate of the probability is as good as anyone else’s. I’ve put my own money on the line, based on an estimated 90% probability of success. If Bex fails, that’s not the end of the story, but it would definitely cause a time delay and heavy losses, and I’ve already accepted that.
These >30% daily drops don’t feel great, but we’ll still rise from this pile of crap 
Is this really Juho’s contribution to the offering??
Just when the offering presentation went well and built confidence in the success of the offering, these kinds of “mini-investments” are published. You can’t help but laugh at this. For some reason, though, it’s not funny. Hopefully this wasn’t all of Juho & Co’s investments, but just the beginning. Hope so.
In BEXMAB, it was observed that Bex+aza increases the number of precursors for three blood cell lines in the bone marrow. These precursors develop into functional red blood cells, white blood cells, and platelets. Comparison with historical cytopenias with aza looked good for Bex+aza.
Faron has filed a patent application for promoting bone marrow recovery with Bex after cytostatic treatment: WO2025141246A1 - Clever-1 inhibitor for promoting hematological recovery when using chemotherapy - Google Patents. It is based on animal studies.
Now it still needs to be proven that Bex’s effect is specifically what increases those blood cells, and not just Bex+aza. That could be done in BEXMAB phase 2b. After that, if it’s determined that Bex is the key, it would still need to be proven that the blood cell treatment phenomenon isn’t just due to removing the MDS blasts’ interference with blood cell production by eliminating the blasts—meaning it might be applicable to all cancer treatments.
Some indication of cytopenia related to cytostatic treatments will be obtained from the sarcoma and breast cancer studies when comparing to historical cytopenias in similar patients. If strong evidence emerges for bone marrow protection alongside the primary focus, i.e., cancer treatment, the potential efficacy will be set in stone in randomized cancer trials, which the currently starting IITs will also eventually lead to if successful. If cancer efficacy doesn’t materialize, but bone marrow treatment efficacy does, it must be separately studied with multiple cytostatics.
Cytostatics differ in how much they affect blood cell production. Some diseases require heavier and/or longer combinations than others. Cytopenias can be partially corrected with current treatments, and new treatments are being developed. Undoubtedly, there is room in the market. There are also diseases where the bone marrow functions deficiently for years, such as low-risk MDS (LR-MDS), where red blood cell production cannot be corrected with current medications and patients are exposed to large numbers of blood cell transfusions with their side effects; in such cases, a potential Bex treatment for the bone marrow would also be necessary. In the words of Assoc. Prof. Kontro, let’s first see the efficacy in randomized first-line MDS. Starting soon.
I noticed the same thing, it didn’t inspire confidence.
If we play with the idea:
1,142,060 MO, sell at €0.011/ea, you get about €12,500.
And lo and behold, 23,656 units * €0.5 = €11,828.
