Good point about the ASH conference and a possible BTD afterwards. The reason for this is that the FDA actively participates in ASH and often sponsors it. So, ASH is precisely the place where the final discussions with the FDA take place, before possible next stages. Faron has acted quite wisely by leaving publications for these events.
17 Likes
Well.. Could one perspective be that the FDA has also wanted to seek an additional interim reading with dose optimization. Itâs cemented in their own rules that accelerated marketing authorization is no longer granted based on f2. However, thereâs a crying need for an effective drug in MDS, and in the rules, accelerated marketing authorization is possible when the f3 plan is ready and underway. As a holder, Iâm keenly following what the
16 Likes
Hereâs a comparable company to Faron, Terns Pharma, CA, USA. Letâs see how things are done properly now
Phase 1, practically 1 asset TERN-701, for chronic myeloid leukemia. CML is a much larger market, though there is also more competition there.
TERN published oral presentation data at the upcoming ASH. In Phase 1, four doses were tested in a total of 55 patients. 2 doses have been selected for Phase 1 further testing. (how familiar that soundsâŠ) The results were good. Stock +200%. MCAP over 2B now.
I have often pressed why Faron fails to publish bits of information here and there. (Regarding r/r patients, I have, for example, asked: how many discontinued, how many withdrew consent? previous treatments? durations of responses? precise definition of responses?)
Read Ternsâ and Faronâs press releases and abstracts consecutively. You will notice the difference in the precision of data reporting. The market rewards that (+ of course, for excellent results)
24 Likes
I certainly agree with this. A company that isnât yet making money doesnât benefit from a vague attitude towards investors. Now Faron is failing to use all possible ways to convince investors. Investors are expected to trust repeatedly given promises about a deal, which are just words. Maybe those words will hold true, and then weâll think it was worth believing. But if those words donât soon materialize, Faron will have no way left to convince anyone. A company in trouble might then be bought cheaply by someone when investor confidence is lost and a deal wasnât reached due to overly high expectations. Faron is playing a tough game, hopefully victoriously.
10 Likes
The optimization of the dose size, and why it is happening (only) now in practice, is directly related to this. In MDS/AML patients, responses vary greatly depending on factors such as age, genetic mutations, and previous treatments. Statistically valid dose signals could not have been obtained from small and heterogeneous groups. Instead, at this stage, it is more important to obtain data on preliminary efficacy and safety. And that has now been obtained, and if we can just wait, then further results will follow after ASH.
In my opinion, this cannot be considered a setback, as @ValkoinenPeura thinks. First, a promising efficacy and safety signal is collected, and then the dose is optimized in a larger, purpose-designed study. This is precisely the phase Faron is now entering. So, itâs quite normal.
Comparing TERN-701 to Bexmab, in my opinion, falls into the category of comparing apples and oranges. The TERN-701 program is a classic early-stage Phase 1, where dose escalation is tested in a highly controlled CML population. CML is a biologically more stable disease, where dose optimization is technically much more straightforward than in acute myeloid leukemia or high-risk MDS. MDS/AML patients are clinically significantly more challenging. That is why, in this Faron model, the FDA also allows dose optimization to be carried out only in a larger, registrational phase.
21 Likes
Iâm being lynched here again, it doesnât matter. Iâve often been critical of Clark Kent too, but I think he now has a point here. Things left unsaid tell just as much as things said. Why is a certain communication line chosen and why is that communication changed? The longer Faron remains silent and ignores investorsâ questions, the more worried I become. Many now consider silence a good sign, as did I before, but the âsoonâ phase is already over. If ASH doesnât bring that deal, then after that I will view this as my own investments potentially going to zero and the tuition fees being paid. Too long have good things been promised now, and the goalpost always moves. A line must always be drawn somewhere, and for me, itâs pretty much here.
12 Likes
Well, no lynching, but letâs repeat the previous question: what should have been communicated that has been left uncommunicated?
Perhaps you could provide a concrete bullet list as an answer, so maybe Faronâs IR will react? I would help with a few initial points myself, but unfortunately, I canât think of any bullets.
9 Likes
Letâs think for a moment now.
If Faron is in the driverâs seat, should they have taken out a new loan? In my opinion, no, because these negotiations havenât just started now. They have been ongoing, if managementâs statements are to be believed, for months, if not years. At some point, those negotiations will also conclude. Faron itself has stated that it has no intention of taking Bexi into phase three alone. Now we are at that threshold, and if no deal materializes, what are the options? Do we close up shop, or will someone again squeeze the balls and weâll have to buy more time and change strategy? Who will still have faith at that point, when words have no backing and the can is constantly being kicked down the road? Or will BP come and buy the whole company cheaply at that point? Why arenât questions posed by, for example, CK, being answered, regarding what has been left unpublished from the study? If those things are not to be reported, one could at least briefly state the reason why not. Many questions have been raised here that concern investors. Uncertainty is poison for investors; all investors know that. If the deal is just awaiting signatures and comes before Christmas, I admit Iâve been impatient and humbly apologize to everyone. But if itâs not, then itâs quite short-sighted to disregard investors and assume that in a few months we will all happily participate in an offering and listen to the same promises for a few more years. Now we are at the point where words must be backed up by action. Soon! We canât always proceed by waiting for the next results; with that strategy, weâll soon have a finished drug and wonât even need a partner. That is, if the money taps stay open and if the strategy is changed on the fly. An extraordinary general meeting has already been proposed here, and that indicates that even the big investors are starting to get frustrated, and with potential offerings in mind, thatâs a very bad thing. I eagerly await the next shareholder list.
6 Likes
It could also be that Faron is playing hardball for a good deal, knowing that a rejected bad deal can likely be revisited.
5 Likes
Letâs just say, so that such a remark doesnât linger on the forum unnoticed: Absolutely not. The information published by Faron is certainly completely accurate. I only need essential clarifying details. These are especially needed for evaluating studies without control groups.
Independence Day week is starting, I will now withdraw into silence until the ASH resultsâŠ!
16 Likes
Oh, what a surprise, an example is taken that supports oneâs own agenda, once again. The matter was corrected wrong again. This is how doctors operate too. Someone might say itâs intentional.
It would be interesting if a book could be found for Christmas that discusses how investors could be influenced. A small company, several creators of noise. This book is a humorous reference, but it is indeed very persistent.
5 Likes
This discussion is now going badly in circles, but this was announced at the beginning of November, on consecutive days. First, that the matter is wrapped up, and the final data will be reported at an âupcoming major scientific meetingâ (=ASH).
After that, they further confirmed that it would be precisely at ASH, and they also explained very well what would be discussed there (read the abstracts).
This has now been communicated and announced very transparently, that you will get more information about this then. Itâs turning into a complete mess, patience, good forum members, and letâs indeed return to the matter after ASH.
Edit: this is mainly for @Maikki1 and this communication panic.
19 Likes
I see this as not being about a new loan; they only drew the second tranche of a previously negotiated loan. That financing wouldnât have been negotiated like that unless there was a thought that it might be needed. Uncertainty truly is poison for an investor, and itâs the same with many other companies. Information mainly comes in interim reports, and after them, we might head for quite a slide. If one canât stand the heat, then one must sell.
ASH is around the corner, and hopefully good data is coming; the coffers arenât empty. Been involved for too long to give up now. If one considers the moment when many put their chips into this and compares it to the present moment, we are in a completely different situation; what are a few weeks/months in a marathon of years?
Everyone, of course, sets their own deadline or goes to a bitter end; the big owners donât seem to have lightened their holdings much, quite the opposite, they have significantly increased their holdings. Hopefully it wonât happen that small investors get nervous and exit, and money finds its way back to money.
17 Likes
Panic is quite an exaggerated term right now. Panic might be experienced by those patients who benefit from Bex but live in uncertainty about how long they will receive Bex. If we were selling sausages to the public, it would be easy to switch to a competitorâs products. Now we are talking about human lives, and then morally and ethically everything must be done to ensure treatments can continue. This is not just an investment case; bigger issues are at stake. And thatâs why I donât feel panic, because the potential loss of my money is not the biggest question here. I have invested in this with the thought that everything can be lost, even probably. But with my investment, I can be part of doing good things, and that in itself is enough for me. Either I profit from this, or I have done charity, and from both, I certainly get a good feeling.
10 Likes
Completely agree. And thatâs why Iâm probably unsuccessfully trying to say that everyone should be patient right now because the results look good right now.
I perhaps interpreted this more as leaning towards panic. In my opinion, CKâs questions are not justified to be presented in this stage of the study in many respects.
And to the extent that they are, we investors have been openly informed that there will be a final data update at ASH. Thatâs when weâll get answers to matters that have not yet been made public.
6 Likes
When was that published? Can anyone tell? My sources donât reveal it.
2 Likes
Wasnât it early November when Faron announced the abstract? Probably then.
2 Likes
Well, at least some answers to the questions asked here are coming.
â Updated response data from November 2025, including duration of response, will be reported from mTP53 and wt groups.â
Webinars always have a Q&A section. Hopefully, it has been utilized when questions have arisen. I wouldnât count just writing here on the forum in the category of âit has been asked, but not answered.â
3 Likes
According to the PDFâs metadata (that version), it was created on November 24th.
3 Likes