At what point has ck even once warned about the issue that the partnership failed over??? It was and is completely senseless to bicker every single day about minor scientific nuances!
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If Juho is to be believed, the whole thing fell apart due to the failure of the Verona study and the resulting delay. Itâs unlikely that Clark or anyone else foresaw that. Instead, he has frequently warned about excessive valuations and the general risks associated with biotech companies in the research stage, such as Faron. Now, that valuation has taken a major hit.
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Wow, thatâs quite a plot twist, doing a 40m rights issue, although it certainly didnât come out of the blue.
Who would toot their own horn if not themselves.
Value creation also occurs in a situation where funding is secured. I argue that Faron has a discount due to funding uncertainty, which will disappear once we get certainty on how phase 3 will be funded.
So the situation is an x% probability of a partner deal, and y% probability of a funding crisis and equity-based financing from a weak position.
The favorable window for raising equity-based financing is kind of gone already, if itâs not somehow linked to that deal.
For me, Jurriaanâs reduction served as a warning sign, and I cashed out my disproportionately large stack immediately upon that announcement. You have to know a bit about Dutch culture to understand that thereâs no kitchen renovation coming up; if you have 8k of your own money tied up, youâd be a fool not to take your money out. There are no âcompany menâ there; self-interest is what matters.
Even though I avoided this bomb, Iâll also state that my investment thesis for this company has now been reset since the next phase is also being done through self-funding, and I no longer want to carry any more binary risk. (Maybe age and my life situation are starting to weigh on me)
Also, if you look at the 5-year price chart, you can see that buy and hold has not been a winning strategy, but there have been plenty of opportunities for swing trading.
Iâve been a Faron permabull, but now the sentiment has shifted and I intend to reduce my participation in this thread. I no longer follow the cancer treatment markets for work, so the topic isnât as engaging anymore, and with kids, time is more precious, so I can cut back on following a single biotech and maybe just buy ETFs monthly. Good luck to the company though and all the best, but this no longer suits me. Farewell.
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Indeed. I personally donât understand why Dekkersâ sale should be swept under the rug now. We are in Finland, not the Netherlands.
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This is a sharp opinion and, for now, an unproven state of affairs. As I understand it, the diseases studied in Bexmab are all ones where Bex could mechanistically work. Myeloid blasts have high Clever-1 expression. However, encouraging results were mainly obtained in MDS. But here comes the problem when the entire trial starts to be viewed as several sub-parts. In this case, the probability that a positive result occurs by chance in at least some subgroup is emphasized. Faron hasnât explained more deeply the basis for why specifically MDS is the one where the drug would be particularly effective vs. other Clever-1 expressing blood cancers. The explanation might still be hidden somewhere in the depths of Maijaâs laboratory publications. And of course, one must âgo towards the signal,â but in my opinion, the signal should have been looked at from Bexmab as a whole (go/no-go, would better added value have been available from PD1 drug combination trials, for example).
There was so much discussion about this that the core has likely been lost already. So, cCR is not even an endpoint according to IWG2023, which Zeidan himself authored. And the FDA requires endpoints that have been prospectively shown to be related to the benefit received by the patient. Composite CR likely circulated in press releases because it sounds good and reporting it yields a high % figure. It would only have been an actual error if it had been implemented in the study. This was followed by an FDA consultation where the endpoint was redesigned. But it told me that Faron (CMO first and foremost) doesnât have a perfectly sharp understanding of the design of these trials.
It is quite true that we donât know what kind of results a different, less aggressive strategy, for example, would have brought, so itâs hard to say anything for certain.
And itâs true that piloting a First North biotech through the valley of death while pleasing all stakeholders is likely an impossible task. There needs to be a touch of âAmerican style,â strong belief and promises are needed, accepting the managed risk that one can fall from a great height. But I wonder if the strategy has been aggressive in all respects. Has Faron done everything possible to scrape together equity financing when the valuation was high? Why is SyrjĂ€lĂ€ the only institutional-grade anchor in this project?
This is quite tricky now; Juho seemed to confuse the listeners. There were at least 3 reasons for the failure of the OS endpoint in the Verona trial: 1. the drugâs efficacy was too weak vs its adverse effects 2. post-protocol treatments, i.e., the trial setting for some subjects became âaza+ven now vs aza+ven laterâ 3. functional unblinding, meaning doctors could conclude with such high certainty from the side effects who received vene and who didnât that they dared to start venetoclax on top of the âvenetoclax placebo,â so the comparison was essentially aza+ven vs aza+ven.
Of these, 1 is drug-related, not design-related. 2 is normal in cancer research (a âlots of water under the bridgeâ situation, where there is so much time between the intervention and the endpoint that treatments following the study intervention carry the most weight). 3 is a real problem, especially when itâs so obvious that doctors take the risk of dosing venetoclax on top of a presumed placebo. If this were a misjudgment and the patient was already receiving venetoclax, they would get a double dose which could be fatal⊠And in any case, 3 completely dilutes the research design.
Then, how the aforementioned factors would jeopardize Bexâs trial specifically in the OS comparison might not be as straightforward as Juho explained, because bex is not an approved drug, so points 2 and 3 cannot occur in the sense that we would end up in a bex vs bex setting. But we could end up in a bex+aza vs aza+ven setting. But that would even be desirable, because the setup would then study as well as possible what happens in practice. This is the purpose of a phase 3 study, and this is about Intention To Treat analysis.
It must also be noted that the OS endpoint could benefit bex in many ways. Biomechanistically, one could think that as bex activates long-lasting adaptive immune responses (I donât know if there is research evidence for long-term ones yet), the response persists for a long time and would be seen specifically as a survival benefit. Secondly, as Zeidan or one of the KOLs said, bex could work as a âbridge therapyâ to bone marrow transplant. With an Intention To Treat protocol, âeverything counts,â meaning those who received a transplant are not censored in the analyses. In this case, the Bex group would likely benefit significantly in the OS comparison because getting a transplant on average brings a lot of additional survival timeâafter all, itâs the only curative treatment! The CR endpoint doesnât capture this benefit at all.
Also, focusing on the CR endpoint now doesnât save from protocol deviations, such as giving venetoclax. But that applies to both groups.
Itâs very hard to say what the net effect is if the phase 3 endpoint is CR vs OS. Itâs clear that the trial is shorter and cheaper. But in light of the information so far, I would understand that the chances for a win would be better with OS. Iâm leaning slightly towards disappointment here. But anyway, it seems certain only for the phase 2 CR, for which it fits perfectly. The decision on phase 3 will be finalized later.
Thank you, I wear the title with pride. My bearishness started purely from the valuation and gained momentum from the opposition I encountered, which sort of drove me into this role. The valuation has now been reset, but regarding the results, the fat lady hasnât sung yet. Many of my anticipations are still open.
If previously Faronâs valuation was based on the equation (results + execution + financing outlook with a strong SyrjĂ€lĂ€-backbone + expectations of a value-creating licensing deal), now the valuation is, in my view, more purely worth the results. At the same time, it must be noted that the lower the valuation is, the more âunstableâ it becomes, as biotech financing rounds are large. On Nasdaq, many biotechs similar to Faron have been seen after Covid, valued at cash or even below it. Gubrick isnât talking about the death spiral for nothing.
To continue helping other investors with this in the future, however, there would be reason to try to break free from the permabear status. But what do I know, objective self-assessment is probably impossible by definition. Iâm starting to look at this mostly neutrally. But Iâm not buying to bet on the outcome of the share issue. Iâm more interested in the data Faron provides. I look at it critically/skeptically, and I would hope for much more detailed reporting. One could take a model from the better biotechs on Nasdaq. But regarding the valuation, I am neutral. Perhaps the market will still give me a place to strike here one day. Now it is closer than ever before. Not investment advice.
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The companyâs interest is what matters. Apparently, Dekkers is still needed, so he still has time â if and when there is no added value, he will likely leave immediately. Now, this market bad will is weighing so heavily on Faron that I bet Jurrianâs best-before date is around the day of the Annual General Meeting. š
This companyâs paths, both forward and backward, are indeed unexplored and foggy. It makes this story completely exceptional in my own investment history. There is no compass of experienceâŠ
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Well, I didnât say that we would end up in a Bex vs. Bex situation, but considering the goal of the study, a Bex+Aza vs. Ven+Aza setup is just as detrimental. In a study aiming to determine the efficacy of Bex, there can only be one variable, and that is Bex. If the control group is given something else in addition to Aza, then the results for groups A and B will differ even if neither group receives Bex. If Bex is removed from the equation, there should be two groups of patients left who receive exactly the same medication.
If we wanted to study whether Bex is better than Ven (i.e., the practical difference), comparing study results would show that. However, Bexâs trials cannot be compromised by giving the control group Ven in addition to Aza, because then no one will know what causes the differences.
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MSMâs weekly comment:
âAmong the weekâs other losers, Faron Pharma suffered a brutal 60 per cent drop after unveiling plans to raise âŹ40 million.
The reaction appears disproportionate given the drug developer intends to use the new investment to advance its blood cancer treatment bexmarilimab into later-stage clinical trials, a necessary step that could deliver long-term returns.â
In my opinion, a fairly sensible comment from the big world to the big world.
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Letâs recap a bit, otherwise there might be a misunderstanding. Composite CR, or cCR, is specifically an FDA-approved endpoint for the phase 2b/3 trial. https://faron.com/releases-and-publications/inside-information-faron-to-advance-bexmarilimab-into-a-registrational-phase-2-3-study-in-treatment-naive-frontline-hr-mds-after-positive-meeting-with-the-fda/ Or rather, it already was, in case the primary endpoints were to somehow change in the future.
But cCR is not yet a metric directly suitable for marketing authorization, i.e., a primary endpoint; instead, it is secondary. Secondary endpoints are additional measures that support the primary finding and provide a broader picture of the drugâs effects. The purpose is to gather additional evidence of efficacy, quality of life, or specific responses.
According to what Zeidan presented in webcasts, the idea of efficacy regarding cCR comes from registry studies; peer-reviewed articles were awaited, one of which was Prof. Lisa Pleyerâs prospective real-world registry follow-up study. It still hasnât appeared on PubMed, if I looked correctly. Zeidan will likely clarify the matter in the future, as he is the best informed on the subject. The quality of life aspect comes from the recovery of blood cell lines associated with cCR, meaning a reduced need for blood transfusions, fewer hospital visits, and, for example, the prevention of physical deterioration caused by anemia.
Future developments regarding this endpoint also involve additional recruitment for the City of Hope r/r MDS IIT or a new trial. CR is very rare in patients who have failed previous treatments. The improvement in OS (Overall Survival) during Bex treatment is therefore likely related to responses other than just pure CR (and bone marrow transplants, unless they are censored). The previous r/r MDS phase 1/2 was conducted using IWG2006 criteria; now the criteria have changed, allowing for evaluation via cCR as well, but no prospective clinical trial has been conducted with it yet. BEXNovartis (sorry) was supposed to be the worldâs first such trial. It will be interesting to see what the experts decide and, in Juhoâs words, an exciting continuation follows.
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