The article contains the wrong year; the company invested in Faron in 2015, not in 2025 as the article stated.
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How do you think about that study design for Vene+Aza? In a randomized study, itâs obviously a clear case if Vene+Aza is more effective than Aza monotherapy. But why isnât Bex+Aza acceptable if it proves to be better than Aza monotherapy?
One argument has been that marketing authorizations have not been granted for combination drugs before, so why are such Vene+Aza studies even conducted?
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You are at the heart of the matter. When one delves into previous approvals in oncology and hemato-oncology, it becomes clear that it is very rare for an approval to come for a combination where one component has not been previously approved for anything. Venetoclax, however, has already been approved for AML.
But that is, of course, just a statistic. Situations must be looked at one at a time, but in my thoughts, that statistic reduces beksâ LoA%.
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Thereâs no point dwelling on history.
The main thing is probably that Faronâs direction is now northeast.
This story still seems to be as eventful as the rule of a
superpower.
What is the next obstacle / stumbling block?
Will the wiser ones tell us?
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Expectation management, on the other hand, has been the kryptonite of Faron investors. When the CEO visited Inderes to praise the company shortly before the directed share issue, talking about this issue was a direct insult to all parties. When the issue was then made exactly as expected, there was strong reassurance that this was just interim financing, as the partnership deal worth hundreds of millions or even billions was just around the corner, and big pharmaceutical companies were practically rolling out the red carpet for Jalkanen to create a new revolutionary cancer drug for them.
Well, now a longer-term financing solution has been made for Faron, which strongly signals that no partnership deal is coming anytime soon, but still the prevailing idea seems to be that a Finnish small investor will trick the stupid procurement teams of pharmaceutical giants by buying Faronâs miracle drug from the stock market at a bargain price. Those professionals must be utterly stupid if they refuse to make a deal.
Thereâs a tremendous amount of detailed technical expertise and intricate skill in the thread, but that famous common sense doesnât always seem to keep up. The atmosphere is like listening to Polandâs Markkuâs stories on the Voxtur forum back in the day. The financing is only for a year, so next weâll be waiting for a new share issue or convertible bond, which will probably come sometime in Q4 2025. If things go well, some weak deal might be concluded in the autumn, but before that, there will be tremendously stormy price movements both up and down.
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That is indeed a clear difference: Bex has not been approved for anything, but Vene has. However, it doesnât make sense to me that it couldnât get marketing authorization if itâs scientifically proven that as a combination therapy, it is better than Aza alone.
Science is evolving, and in my opinion, we should expand beyond oncology and hemato-oncology and simply see if any drug has ever received marketing authorization for any treatment solely by demonstrating combination efficacy. Similarly, the IGW criteria also update as science develops.
In any case, Bex is not intended to destroy cancer cells, but rather to make them âhotâ so that the human immune system can attack them. For this reason, patients who have failed previous treatments are also a difficult target group, because - as you have noted - their internal organs are already damaged. And this is precisely why Bex should target first-line treatment, because there it has the potential to work more effectively, as Aza + the bodyâs own immune system attacks these âhotâ cancer cells.
In my opinion, no definitive facts have been presented for or against Bex certainly working this way. There have been indications, and the work (+patent application) around Clever-1 sounds reasonable, and there already seems to be at least good evidence for it.
Once the first fact completely ruling out Bexâs possibilities is presented, I will jump off this train (of course, the money will have been lost by then, but so what, itâs a conscious risk). However, I havenât encountered such a thing yet, and I will continue to be bullish.
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Even if venetoclax were to receive marketing authorization for MDS as a combination therapy with azacitidine (it does not have marketing authorization for AML as monotherapy), it would not affect Bexâs chances of obtaining r/r MDS AA marketing authorization in any way, as the venetoclax trials were discontinued in that indication.
It would likely not affect first-line either, unless Bexâs efficacy was poor.
For the reasons that
- Venetoclaxâs efficacy will eventually run out anyway. Something must be available after that. The same, of course, applies to Bex.
- The mechanism of action is completely different
- Bex has a better safety profile
- It may turn out that venetoclax does not work for a certain patient group or cannot be used, and there should be some option for them too
Why would the FDA have directed Faron to seek AA marketing authorization in a specific way (start Phase 3 in first-line and look at responses and mOS in r/r), if everything were so depressing and hopelessly impossible? Perhaps they donât read this forum 
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Well, one should not overinterpret that message, not even as a preliminary promise of anything. The FDA merely states that this is the route.
Good that you brought up AAs. I used the Accelerated Approvals found on the FDAâs website in oncology and hema-oncology as a basis. I Googled, researched, and asked AI, and we concluded that combination-AA approval for a combination, where one part has not been previously approved for anything, has occurred 7 times in human history. The trade names of these drugs are Polivy, Xpovio, Padcev, Ibrance, Perjeta, Tykerb, and Erbitux.
The AA program was started in 1992! So, every three years, one approval for such a setup in the entire worldâŠ
And Becksi is trying to join this group, and some think the probabilities are close to 50%? Allow me to laugh.
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The FDA has traditionally been trusted, and its processes have worked. Now there is concern about how the administrationâs streamlining will affect things. The agency has other responsibilities besides just medicines, but itâs quite possible that Faron will also get its share if things start to falter: meeting times are hard to get, matters are delayed, and - as in the example below - there is no longer sufficient substance to make proper decisions.
Large companies generate billions in annual sales from approved drugs, while smaller biotechs might develop as little as one drug. Their success and investorsâ support hinges on regulatory milestones, making every interaction with the FDA key.
At one biotech preparing to test an experimental cancer antibody, the companyâs request to have study subjects provide a second biopsy was denied by the FDA, according to a person familiar with the matter.
The company has conducted trials for other drugs in which subjects get two biopsies, and European regulators approved it for this trial. A second biopsy in the U.S. trial would have allowed the company to measure how tumors change over time and regulators increasingly allow them in trials, the person said.
In denying the company, the FDA first cited agency guidance that was drafted but not yet adopted, which said the biopsy could only be a secondary goal of the trial, the person said. When the company responded by agreeing to make it a secondary goal, the FDA then said no because there wouldnât be a benefit to the patient, the person said.
The denials, the agencyâs reasoning and the speed at which the subsequent denial was issuedâa few hoursâmakes the company suspect a less-experienced staffer was overseeing the process, the person said. The company could have appealed but that would have meant delaying its early-stage study, the person said.
Source: WSJ.com
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So when reading these messages, it went wrong, itâs not working. What are the chances, are there any left, why did Hong Kong sell everything, strange.
Can someone explain in non-medical language, is there any hope at all to get the product successfully approved and onto the market?
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I said that one should not speculate on the factors guiding patient enrollment in trials, but Iâll throw in a counter-argument here as wellâŠ
I think that r/r patients are directed to BEXMAB very early (even immediately after 4 cycles), because according to the protocol, AZA continues anyway and Bex has minimal side effects. I.e., nothing is lost by switching to BEXMAB. This is how I would reason if I were an oncologist 
This explains the good ORR%, because it includes the delayed effect of AZAâŠ
Instead, for monotherapy trials, r/r patients are likely directed to those for whom it can certainly be said that HMA is no longer effective, meaning they have had more cycles.
Now, close the forum and enjoy EasterâŠ
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As previously stated, medicines eventually lose their effectiveness in cancer diseases, and it would be good if there were effective alternatives. If Bex maintains its efficacy and safety, why shouldnât it become a medicine? The need is great. Now, that large sale occurred in a peculiar situation, which undeniably raises suspicions. As does the rather vague announcement of preliminary results, which did not mention what criteria were used. On the other hand, the results were in line with expectations. If the outcomes for the remaining patients remain in the same proportion, then the results are tremendous, and there have been no safety issues. Everyone certainly wants a medicine on the market whose side effects are as minimal as possible and which improves patientsâ quality of life. Partnership news would be great at this stage. Now, just follow Juhoâs whereabouts; that will tell quite a lot. Iâm not encouraging anyone to stalk, though; a little social media âstalkingâ should suffice. 
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To add a bit more to the mix. The Aza+Vene combination is already prescribed, at least to some extent, for first-line treatment of HR MDS. Someone from my close circle is on this combination outside of a clinical trial. The treatment location is Slovakia.
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Juho confirmed that it does not affect in any way, nor does it mean that things would be easier to get through. This is a significant matter for all parties that when the criteria are met, nothing will stand in the way.
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This was a good write-up; thereâs a lot of detailed information here, but less is said about the investment aspect itself. I also remember when Juho blurted out last autumn, in some context, into the mic at the end of the last event, that partnership news was expected next or something similar.
But I also understand the perspective that when financing is difficult in this sector right now, you also need to have self-confidence. According to someone lacking confidence, itâs harder to approach financiers, because returns are sold through perceptions. And in my opinion, those financing arrangements have been handled well recently. In that sense, Juho has indeed handled this well.
But these require patience and the ability to wait, and I donât have either. Thatâs why Iâve been trading this in and out. But Iâve always kept a small position, even after lightening up, just in case of that deal. And things are in better shape than a year ago. And I wouldnât be surprised at all if some deal were reached this year.
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Letâs just say that you shouldnât base your investment in any company solely on forum messages, even if you sometimes read good things there. If you also read, for example, Inderesâ or Carnegieâs analyses, you donât get a very depressing picture of the companyâs situation. Of course, there are risks, but there always are. Now, just calmly wait for the more detailed data from phase 2 and the scientific communityâs comments on it; thatâs where the most authoritative expert opinions will come from. After that, we can start waiting for the drug agenciesâ statements⊠Investing is often endless waiting, unfortunately. Perhaps at some point, while waiting for future events, we will notice that the companyâs affairs have gone well and our own assets have grown at the same time 
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When reading these messages, it went well and seems to have succeeded - of course, the details are under embargo for a short time.
An owner who invested due to trauma sold their shares, and no conclusions can be drawn from this regarding Bex.
Letâs wait a moment for the details. In the meantime, letâs remember that a mediocre drug is sufficient for marketing authorization when the alternatives are terrible. I have strong faith in mediocrity.
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And I would add that investing in anything should not be based solely on any forum, analysts, a companyâs CEO, or a bankâs advisor. Or even neighbor Esko, who seems to know everything about everything. They are just people too.
Itâs worth doing some background research, and perhaps Googling the probabilities of similar companies succeeding after Phase 2 as a basis. AI would gladly create tables of these.
And even those donât tell the absolute truth about things; thereâs always a risk for you. But the higher the probability of things succeeding according to the investorâs wishes, the better the hit rate will be in the long run. One might fail, but after 5 or 10, youâll be profitable, provided the parameters are estimated relatively correctly.
Or you can play one company or card if you are absolutely sure about it. That also suits some people. Itâs worth finding your own niche where you can make a profit.
For me, in these cases, itâs technical analysis; I buy when thereâs fear or an offering has been realized, and I sell at different price levels when FOMO takes over. With this, youâll never get those amazing 10x or 20x returns (unless you get incredibly lucky and a deal comes through just when the allocation is 200% and thereâs a huge overweight). But this has also worked quite well; I consider over 100% annual returns to be a pretty great thing, and last year I achieved that due to a public offering.
And if we take one comparison, albeit from a slightly different indication, I have MindMed [MNMD] among others from the American continent. There, a âBreakthrough therapy designationâ came last spring, and the stock jumped to $12. The cash on hand is currently around $270M, and the market cap is about $430M. And currently, the stock value is under $6. The cash runway should be sufficient until the end of Phase 3, i.e., until 2026, and additional funding may not be needed.
Its market cap hovered around $2 billion sometime in 2020 when Biden was elected, and there wasnât a single Phase under its belt then. And the cash burn hadnât even started. This probably tells a lot about how undervalued all biotech stocks are currently. The NBI, or Nasdaq Biotech Index, tells the same story, having just hit its post-2023 lows a moment ago.
The purpose of this story was mainly to illustrate how wildly the valuation of these papers fluctuates depending on the phase of the stock market cycle. In a good cycle, Faron would be a 5-euro stock now, perhaps.
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âIn this project, we will integrate concurrent efficacy data, obtained from the BEXMAB trial, and detailed molecular level information about bexmarilimabâs mechanism-of-action by single-cell RNA sequencing of patient bone marrow samples before and after treatment. We will also implement mouse models of chemotherapy-induced leukopenia to study Clever-1âregulated hematopoietic recovery, a phenomenon observed in BEXMAB patients after bexmarilimab administrationâ
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What if these patients are pumped full of aza and it just doesnât take effect until they get bex? 
Surely such results wouldnât have come about if bex were useless.
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