Faron Pharmaceuticals - Innovative medical solutions (Part 2)

[Pati]

@Clark_kent

from the Clever-1 basket trial in expressing blood cancers, MDS is apparently chosen because the best responses were found there (inflation of Type I error)

Can you elaborate on this a bit or link an older post where you’ve discussed this? Isn’t it quite normal to focus on a standout indication? A strategic choice?

@Clark_kent

since composite complete response looked good, it was proposed to be used as an endpoint without a proper scientific basis

Isn’t cCR as an acceptable endpoint in line with FDA guidelines, or what are you getting at?

To clarify further, I don’t (necessarily) disagree, but I’d like to hear more about this in detail. There are quite a few posts here, and the search function generates a staggering number of results for the keywords cCR+endpoint.

Do you believe all of these were mistakes, rather than, for example, an aggressive biotech strategy (a choice) that backfired (and ran into funding realities)?

[ZSilver]

Isn’t it about time to admit.for quite a few here.that.Clark is no loudmouth here.but exceptionally well-informed. I myself counter Mr. Kent in a few foreign stocks in Sweden and things haven’t gone badly there. In this one [I am]. But anyway. Bought for a euro at Midsummer and sold for three in the autumn and back in again with an average price of 74c… Maybe someone will take this Bex to the finish line . The 60c buyers will be thankful when they sell at 2 euros. That’s how it went with Biohit too. Buy buy while you can get it cheap now. This.opportunity to get even slightly rich

[Piirinmestaripohatta]

I would also like to comment on this crash by saying that the market reaction was quite drastic. Too drastic.

If we look at the share price throughout Faron’s entire time on the stock exchange, the trend has been quite stable and slightly downward the whole time. Granted, there has been dilution along the way and that compensates for it to some extent, but the point is that there wasn’t at least any massive hype in the price caused by an approaching partner that would have now unwound. The science and goals behind the company are still the same as they were when partnering was still talked about as a distant dream. Now we are in the exact same situation, only the valuation has collapsed.

Not investment advice, but I myself grabbed another slice for my risk portfolio with the idea that the price might correct even before the share issue.

[OsakasOssi]

@Clark_kent

Juho says in the video that they believe Bex to be the first disease-modifying treatment but at the same time they are afraid to take the risk that there is no efficacy in the survival comparison, because the control group might receive, for example, venetoclax (wasn’t it supposed to be a bad and ineffective drug?). Well, this is of course completely illogical.

The purpose of the study, after all, is to study Bex. This means the study should have bex+aza versus placebo+aza. In that case, the differences observed in the study can be confirmed with certainty to be caused by Bex. If the comparison is bex+aza versus vene+aza, the study is no longer just about Bex, and the cause of the differences observed in the study could be either Bex or Vene. Right? The result of such a study wouldn’t be reliable at all! I’m sure you would have been among the first to shoot it down yourself!

[veskup]

I spotted on X that Zeidan gave a presentation on Bex at this conference; The Precision Oncology Saudi Summit (POSS26). Hopefully, the Saudis will show some interest in putting some oil money on the line.

[Jummijammi2]

Yes. I remember the autumn shitshow well, where Clark was keelhauled in a classless manner many times.. The issue was raised, and only over time have the posts that get personal decreased. Thanks to the community for that. We owe Clark an apology.

In fact, without Clark’s contribution and insights, this group of ours and the investment case would probably be doomed - he gives everyone so much to think about. Whichever conclusion anyone reaches is a different matter.

Thanks Clark - pls continue & be a strong voice of truth in the future as well. I bet that 90% of us miss your insights. Rock on!

[Kettu63]

Clark_kent

Now that it has finally been understood here that Clark’s warnings shouldn’t just be ignored, I’d like to offer my own thanks to him. Even though he’s taken a lot of flak along the way, he has stuck to his guns—and why wouldn’t he, since he knows what he’s talking about. Without Clark’s criticism, the hype surrounding Faron would surely have spiraled even further out of control. It has been quite something at times as it is. Hopefully, Clark will continue to provide opposition in the future.

To stay on topic, regarding what OsakasOssi wrote: “If the comparison is bex+aza versus vene+aza, then the study is no longer just about Bex, and the cause of the differences observed in the study could be either Bex or Vene. Right? The results of such a study wouldn’t be reliable at all.”

I also think there is a problem if the study is “muddied”?

[poiju]

Good catch.

Zeidan on behalf of Yale New Haven, in an academic role. Bex is not just somewhere sponsored by Faron, but part of a broader discussion on MDS immunotherapy.

[Vino_Pino]

How did the 2024 public offering go?
A major financial hiccup was announced in February. The share price dropped from just under 3 euros to nearly one. The CEO and CFO were replaced. Bridge financing was secured. A savings program was initiated. On April 4th, the company announced it needed a total of 27 MEUR to get in front of the FDA with BEXMAB. The price rose to approx. 2.5 euros in May. On June 4th, a 30 MEUR public offering was announced at one euro per share, 30 million shares. The price fell back to near one euro. It wallowed at the bottom for a month. The offering succeeded, and in September, the price was back near 3 euros. It took half a year for the value to recover to pre-hiccup levels from the time the financial difficulty was announced. It took 5 months from the announcement of the need for funds through a share issue. 3 months from the issue itself. Mcap rose significantly higher, as the number of shares increased from 70 → 100 M. Thus, it was quite difficult to “lose money” by force without selling low during that offering, or could you tell us how, @mestaripancho?

Past performance is no guarantee of future results.

Back then in 2024, only BEXMAB Phase 1 (a “basket study” investigating safety and preliminary efficacy in several cancer types) had been completed, yielding important information: it’s not worth putting money into a larger trial for r/r AML; instead, move towards r/r MDS, where there is market need and room. Funds weren’t sufficient to expand into first-line, and fortunately, we only proceeded with a single patient in first-line aza+vene+Bex AML, given what we now know about vene’s toxicity, the need for dose adjustments, and the issues with low-blast count patients.

Furthermore, there was only preliminary evidence from Phase 2 back then. The FDA’s stance tightened regarding Accelerated Approvals (AA) at the same time when those who received AA licenses failed to complete Phase 3. Faron cannot be blamed for that policy change.

It is a strange thought in itself that if we want a partner to pay for Phase 3, the partner wouldn’t need to know what they are paying for and what they are committing to? Just standing idly by while burning administrative costs? This time it went well, as we heard in advance from experts about the recent landmine here for Faron and the partner. And we are trying to avoid it. Now top units and their doctors are on our side; they want access to Bex through trials (e.g., IIT r/r MDS USA). It will be interesting to see how the r/r MDS trial is designed—perhaps just additional recruitment for the single-arm study. A year ago, Zeidan “suggested” from his experience that at least 40 patients should be gathered with OS over a year to potentially get an AA. Whether that holds with current policy, they are likely better informed than us.

At the time of that previous offering, there was no information that we could proceed to Phase 2b and 3 in first-line HR-MDS (the planning changed even now) let alone the investigator-initiated trials (IIT) in r/r MDS, AML, melanoma+lung, sarcoma, and breast cancer. So now we are already closer to the finish line, meaning one could at least assume the company is more valuable than a couple of years ago, but “Viren” must get up—otherwise, we won’t reach the finish line, at least not in first place.

[Kettu63]

A little light relief:

We are now closer to the finish line, so you’d think the company would at least be worth more than it was a couple of years ago, but Viren has to get back up, otherwise we won’t be finishing first, at least (**Vino_Pino**Master).

Now that Viren’s 10,000m run in Munich 1972 is being compared to Faron, let it be noted that Lasse set a world record despite falling.

I wonder what this means in Faron’s case?

[Kulkuri]

Hopefully A. Zeidan’s (Jordanian-born) influence carries weight in Middle Eastern financial circles. Saudi POSS26 is ending today. His BEX lecture there hasn’t been published yet. Let’s wait and see..

[JusaVaan]

Rights issue. How much of a discount to the share price should be offered at minimum for it to work as a rights issue in practice, without an unreasonable risk of the offering failing?

When 40 million is needed, an 80 million share pool at a subscription price of 0.5 euros would indeed yield the desired amount. But assuming the share price stays at this 0.60–0.62 level, the discount to the market price would be just under 20%. Does this equation work in practice?

Or would it be in the interest of the company (not the existing shareholders) and advancing the bex-project to organize a public offering again, just like last time?

In this case, a discount of just under 20% could seem attractive enough, with the share price already being low, that the 40 million financing could be secured from the general public with a fairly high degree of certainty. To appease existing shareholders, they could once again be given priority in the subscription. A public offering would also be cheaper and simpler.

In my view, the probability of success for a public offering would be clearly better than for a rights issue. And at this share price, a rights issue no longer provides a corresponding benefit to existing owners. It seems there are enough “cheap” shares available now for any willing retail investor to buy as many as they dare.

Compared to the past, the current share price may feel “too” low, but above, Clark Kent—who seems to have been well on top of things so far—estimated a “suitable” EV to be around 50–100 million, but in a situation where the company is not in a financing crisis.

Now we seem to be in a financing crisis again, and the EV is in the 70 million range. So there might not be much room for the share price to rise, at least not until this “deadlock” is resolved.

What does the jury think? I’ve started to think that the upcoming offering might still be a public offering similar to the last one, but instead of a one-euro offering, a 50-cent one?

[Vino_Pino]

@Kettu63

A little bit of levity:

Now we are already closer to the finish line, meaning one could at least assume the company is more valuable than it was a couple of years ago, but Virén must get up, otherwise we won’t reach the finish line first at least (**Vino_Pino**Master).

Now that Virén’s 10,000-meter run in Munich 1972 is being compared to Faron, let it be reminded that Lasse set a world record despite his fall.

I wonder what this means in Faron’s case?

To me and the mythical Finn emboldened (sisuuntuneena) by adversity, that means you can stumble in life and face setbacks and still—or precisely because of them—win.

If we consider world records, for some spinners, Faron might represent a world record in bungling. If Faron’s view of Bex’s market potential is even close to being correct, the ratio of low drug development costs to sales upon success would be in the world-record class.

[mestaripancho]

I felt it as a loss, yeah, and you’re right that I didn’t lose anything here since I didn’t sell, but I didn’t really benefit from this rise either; I experience it as a loss at least in terms of time, if not financially. I’ve been along for the ride for many years, buying on both sides of 2€. Then the one-euro offering, a solid five-figure drop; I started smoking again on that day, thinking what the hell, will I never learn from these setups. Well, after a couple of poorly slept nights, I was digging between the mattress for some subscription money. Found a little at least; once the one-euro shares became 1.60€ shares, I sold them. Someone will nitpick that I couldn’t sell the one-euro shares—well true, I sold some 2.3€ shares and took a loss on those, but I treated them as the one-euro shares and brought my average price down. We rose close to 2€; at that point, I was pretty close to break-even.

I decided that while I can still get out of this unscathed, I’m selling now. I never caught the peaks, let alone profits; many, many years were spent playing around with this. I didn’t lose, I didn’t profit, but at least I quit smoking.

The only ones who have gotten rich here are the Jalkanen family and the rest of the crew. Up until now, the investor has just been along for the ride, providing the gas money while Juho does the driving.

[Vino_Pino]

Subscription rights will be available for the public to buy, meaning non-shareholders too, if and when not everyone subscribes to everything. Existing shareholders have priority in the offering. Additionally, the EGM notice states: ”The Company may carry out an additional offering by way of a directed share issue to allocate shares to potential non-shareholder investors based on previous authorization granted by the Company’s last general meeting.” So the big players will likely be allowed to participate regardless of their holdings.

In the end, that doesn’t really differ from a public offering except for the priority right. If you want to vote at the EGM, you must own the shares on Feb 18, 2026. It doesn’t seem likely to turn into a public offering; that would already be a change compared to previous discussions.

@mestaripancho well, if you risk your health while trying to get treatments for others’ cancers sorted (“getting rich” in Ruonansuu’s voice), that doesn’t feel good either. Everyone acts in the way that is best for them. One successful strategy is to avoid taking losses by not selling too early, but I admit that you can lose at least part of your mental health in the process.

[mestaripancho]

but now that I sold at over €2 and bought back at €0.63 for €4k, I just got the position cheaper than two weeks ago, and yeah, if that €0.5 subscription right happens, I’ll definitely buy. But it really is a nasty situation that many newcomers have now experienced; I experienced it myself earlier too. It’s absolutely insane how it starts as a €200M+ company and then the share price is intentionally crashed into a €70 million company. It just didn’t make sense to me last time, and it still doesn’t.

[micoat]

@Kettu63

Now that it’s finally understood here that Clark’s warnings shouldn’t just be brushed aside, I’ll also add my thanks to him for staying the course despite all the heat he’s taken along the way—and why wouldn’t he, given he knows what he’s talking about. Without Clark’s criticism, the hype surrounding Faron would surely have spiraled even further out of control. It’s been quite something at times even as it is. Hopefully, Clark will continue to provide opposition in the future.

Without diminishing Clark’s contribution, my own interpretation of the thread is that panic and dread have been the dominant themes in recent years; hype and praise have been more sporadic. Your post gives the impression that the forum is inhabited by a swarm of investors incapable of independent thought who act solely on emotion.

In my view, Clark has mostly been challenged quite professionally on his interpretations, and he has acted in kind. Some mud has certainly been slung at times, but for the most part, the thread has remained fairly clean in this regard.

Clark is effectively the thread’s official bear, but he’s no fear-monger. There are also a few knowledgeable active bulls in the thread, while the hypesters and panic-mongers tend to be more like hecklers on the sidelines.

I have stated several times that when it comes to Faron, every investor should consider for themselves how much risk they can stomach, as this is a truly risky play where the outcome is all or nothing.

Personally, I’ve invested so little that I won’t lose sleep even in the event of bankruptcy, but enough that if things go well, my financial situation could change radically.

This isn’t a steady performer like Kesko/Sampo/Huhtamäki, and it shouldn’t be invested in as such.

It might be worth considering what kind of amount you can afford to risk without panicking if things go south, because panic is the investor’s enemy. You can avoid the hype train simply by not reading the hype posts.

[Puutaheinaa]

@Kettu63

So we are now already closer to the goal, so one could at least think the company is more valuable than a couple of years ago

That may be so, but the share count has also roughly tripled or something to that effect (after the next offering), so even if the company were more valuable, the share could still be significantly lower.

[Kettu63]

@micoat

Without downplaying Clark’s contribution, my own interpretation of the thread is that panic and horror have been the main features in recent years, while hype and praise have been more occasional. Your post gives the impression that the forum is inhabited by a flock of investors incapable of independent thought who live solely on emotion.

I agree with your post, except for the part above. I apologize if my writing gave the impression that I am belittling the thinking of the forum members. That was definitely not my intention. I have just noticed that Clark’s motives have been suspected and his criticism questioned repeatedly. If measured by “likes,” the so-called positive opinions praising Faron collect significantly more likes than opinions questioning Faron’s results. This is quite understandable, as we are all hoping for success with Faron here. Nevertheless, the criticism should not be downplayed at all, and Clark has meritoriously highlighted points regarding shortcomings in published studies, valuation levels, etc. It’s easy to get swept up in collective hype, confirmation bias, seeking only the facts that please us and ignoring those that don’t. And I’m not saying that this forum is the worst offender in this regard. Having followed other forums, the discussion here is very professional, reflective, and fact-based. That’s why I primarily follow this one.

[WilunGi]

This week, news broke where Moderna shared its views on the FDA’s actions. It was apparently quite exceptional. First, the Phase 3 (P3) arrangements for the influenza vaccine had been agreed upon, and the result was a rejection. If I understood correctly, there were differing views on the interpretation of the guidelines.

I found myself wondering what role the changes in FDA leadership and perhaps—in some people’s view—unstable predictability play in Faron’s situation. Big Pharma (BP) has noted that they’ll take a sort of “overtime”… A couple of years and “Trumpland” will be in the middle of election fever, and hopefully, things will be more stable.

Faron certainly cannot comment on this, at least at this stage. Perhaps it will be clarified years from now in the memoirs written by Juho.