Faron Pharmaceuticals - Innovative medical solutions (Part 2)

Well, this can easily be verified by listening to the briefing again. In my opinion, Juho said quite clearly that in the end it would have been bex vs bex. Not bex vs vene.

EDIT: He says aza+BEX VS aza+VENE. So he doesn’t claim anywhere that there would be a possibility for a bex vs bex setup!

5 Likes

But now, after listening to Jalkanen’s speeches on Wednesday, I’ve regained a lot of confidence.

Especially the Inderes interview is worth a listen for everyone; it’s about fifteen minutes long, so surely everyone can stay focused for that long.

This Faron will be the last biotech I put my money into, but I’m going to see this case through to the end. There’s no denying it’s been an interesting company and stock to have in the portfolio. I still have faith.

13 Likes

As I wrote earlier, now is an excellent window of opportunity for an interested BP for a buyout offer. First, take everything that can be shaken loose from the market at this price, and when the selling dries up, then a “good” offer relative to the present, say for example 3 euros per share. What would the total balance be? I bet they would get quite a good slice and voting share in Faron. On the other hand, a buyout offer only after the rights issue, so that BP could first get the cheap ones from the offering and then, with the share price close to the subscription price, put an attractive offer on the table, whereby many who bought in the offering would get a good return. BP would get the whole thing “cheaply” overall.

Pure speculation. Feel free to delete if this is too conspiratorial thinking.

13 Likes

I don’t understand the panic regarding the contamination of the test series. Couldn’t a ‘ruined’ individual test simply be removed from the series, as in sports, marked as ‘disqualified’? The patient numbers have been pulled out of thin air anyway, sometimes 30, sometimes 40… It’s percentages that are being calculated here. The regulatory authority will then make its decision.

1 Like

Your scenario is very logical. Big Pharma often waits for a small company to drift into a financial crisis, allowing it to “rescue” the company by buying it out at a price that is cheap for the buyer but an attractive premium for a desperate shareholder.

When BP takes Faron private, it acquires the company’s entire “engine room” and intellectual property:

  • Full rights to Bexmarilimab: This is the crown jewel. BP no longer shares profits with Faron; instead, it owns the drug 100% globally.
  • Patent portfolio: All patents related to the Clever-1 antibody (valid until 2040) are transferred to the buyer.
  • Research data and FDA pathway: BP takes possession of all the clinical data that Faron has collected over the years. BP’s own experts take over negotiations with the FDA, which usually accelerates the process thanks to BP’s muscle.
  • Technology platform: Faron has expertise in macrophage reprogramming. BP can use this technology to develop new drugs for other diseases as well.
22 Likes

All other drug candidates would also be included, including Haematokine, Traumakine, and the soluble Clever-1 under development.

5 Likes

At least in the English section of the business update, Juho specifically talks about Ven + Aza, meaning that for some patients, Bex + Aza would be compared to Ven + Aza instead of Placebo + Aza. From around 11:30 onwards: Faron Business Update - Inderes

4 Likes

Exactly. If a retail investor would strategize this way, then the matter is certainly on the table as an option at BP. Of course, this depends on whether Faron and its patents are truly desirable and how Faron succeeds in the share issue. Investor confidence is also crucial right now.

Once again, we are living in interesting times, and I certainly wouldn’t bet against something coming to the table in the near future.

5 Likes

Exactly. My apologies! I had misheard it myself and checked the matter. So Juho wasn’t claiming there was a possibility for a bex vs. bex situation. But rather that the study results would be skewed if bex was ultimately studied against venetoclax instead of a placebo. Quite understandable and even believable now, though. But why did it prevent partnering with the new plan? It’s not logical..

4 Likes

Can BP, which has been involved in negotiations, buy shares now or is it considered insider information? If BP were to buy, a disclosure of a 5% holding would be made public and the share price would rise immediately.

2 Likes

Facts are being thoroughly mixed up here, perhaps partly on purpose?

When the Verona results were published last year, even the experts on this forum said that public Phase 3 (P3) data is rarely available, especially regarding this high-risk MDS case. They only became public at ASH in December 2025.

Venetoclax (Vene) had OS as an endpoint, which was the only option according to FDA guidelines until last autumn. It’s useless to blame Faron’s expertise for choosing OS as the endpoint in early 2025. Besides, Faron itself has been pushing for cCR and CR endpoints all along.

In practice, there have been two (2) months to react with a new plan on how to move this study forward for r/r MDS patients. In that regard, everything looks good now; CR endpoint approval is not the issue, but rather the new FDA recommendation.

However, one should look at the big picture; this MDS TP53 etc. is just one small tree in the whole forest. Faron won’t collapse even if the offering doesn’t bring in a penny. They can put Bex for MDS on ice and wait for investigator-initiated trials if they so choose. Is it sensible? Well, no, because patents eventually expire and Big Pharma (BP) knows this too; also, a blinded study for Bex is needed to get more scientific data from a slightly larger population.

The point is, the MDS market is just a way for Faron to access larger markets found in solid tumors, etc. Someone skilled could make a nice diagram of the market Faron is currently targeting.

Based on the same logic, Big Pharma will not make offers. Novartis won’t do it; they want to maintain good relations because the science itself and the large business case haven’t disappeared. On the contrary, progress has been made all the time.

One could of course ask, if everything looks good in the plans now, why not partner on the same terms as intended in the autumn? Good question, but if 40 million is raised from the offering for a new study that Faron is capable of doing, then from the shareholders’ perspective, it would just be foolish to give away value to others when, even after dilution, the value on 11/27 could be many times higher. With the emphasis on “could,” of course, assuming the results are good. No one denies the risk.

As Faron continues to advance its frontline development plan and addressing the FDA’s remaining question on contribution of each agent testing bexmarilimab + azacitidine against placebo + azacitidine, investigators from the BEXMAB Phase I/II trial believe that the benefit of bexmarilimab in r/r MDS is clear given the data produced to date in the BEXMAB trial. Hence, led by City of Hope (USA) an investigator-initiated trial (IIT) in r/r MDS is also planned to commence in 2026 to produce more data in the last line setting while Faron pursues the frontline setting. This IIT data in r/r MDS is planned to be used for further validation of the benefit of bexmarilimab in last line HR MDS and support the discussion by Faron of potential accelerated approval in r/r MDS with the FDA at the time of the frontline Phase II read out.

Faron also plans to support up to five investigator-initiated trials to further validate bexmarilimab’s potential in combination trials in melanoma, lung cancer (NSCLC), soft tissue sarcoma, breast cancer (ER+ BRC) and leukemia (AML). The Company believes that these additional trials can further strengthen and expand the potential of bexmarilimab in solid tumors, which it expects to increase bexmarilimab’s attractiveness for a potential commercial partnership with biopharmaceutical companies on a global basis.

33 Likes

Will this €40M be enough to complete Phase II (2.0)? How many offerings will be needed this year? The company’s market cap is now approx. €75M. The solid tumor study is a whole different story.

1 Like

It will be sufficient for the P2 readout in 11/2027 and potential AA marketing authorization. It should also be noted that Faron will receive this 40 million from the offering, which simultaneously strengthens the company’s balance sheet.

12 Likes

I have also been considering this. In practice, it would likely be quite easy for a BP to gain control (over 50%) in Faron now by making such a €3 offer, but I don’t believe they would be able to buy the whole company. They need 90% of the shares so that the rest can be subject to compulsory redemption, and I don’t think they would succeed in that. And I believe BP understands this too, which is why they won’t try it. They likely don’t want to own just a part of Faron. They want to merge Faron into themselves, under their own management.

5 Likes

Juho mentioned that they also have good relations with the former FDA Commissioner, Dr. Califf. If I understood correctly, he has been supportive of Faron’s new plan. The current FDA chief, Dr. Makary, seems to have a reputation as a reformer and has worked at, for example, Johns Hopkins Hospital. Since Faron also utilizes a high-quality advisory board, there are likely direct links to Makary through that channel as well.

Hiccup 2.0 is then something that should have been avoided. When looking at Faron’s board presentation, communication is specifically mentioned there. If only for once in Finland, a board would raise its hand and take responsibility!

11 Likes

I don’t believe in a full takeover of the company either, but more than 50% or enough to get voting rights at the general meeting and their own people on the board to steer the company in the direction they want.

5 Likes

To me, these Big Pharma speculations seem like a bit of a psychological coping mechanism to make the situation feel better. Every now and then, these rumors start up that BP is plotting something that would lead to a sudden share price spike. It’s probably more realistic to conclude that the negotiation round was fully exhausted and there wasn’t enough interest to result in a deal or even a framework agreement supported by bridge financing. Now, they really need to secure funding to produce peer-reviewed data that is hopefully good enough!

18 Likes

I take full responsibility :man_raising_hand: for the BEXNOVArtis (confidential) delay as well, of course, but it was I who was hallucinating in the thread that Juho meant Bex could eventually be against Bex, as happened with venetoclax. It really can’t for now, because there is no label, so there can’t be off-label use either.

From the webcast, Juho: Why do MDS Phase 3 trials fail? Mainly due to post-trial medications and bone marrow transplants. In Verona, the setup regarding OS (overall survival) was not ultimately the original setup of placebo + aza vs. venetoclax + aza. The toxic combination led to discontinuations and dose reductions (though this shouldn’t be an issue with Bex). After the trial, 20% of the placebo group received venetoclax.

Juho hasn’t just invented the situation where there’s a real problem that some patients would likely receive aza + venetoclax after discontinuation or loss of efficacy in the context of BEXMAB-2. He gets this information from the treating physicians, and it’s useless to try to refute that information. This was about factors that lead or have led to the failure of MDS Phase 3 trials. Thus, the counter-argument that patients in other trials also receive other medications only proves the point—if the probability of failure increases when statistical analyses fail.

There have already been observations in the thread about how bone marrow transplants also affect OS and censoring, making statistical interpretations difficult. BP (Big Pharma) doesn’t take risks, and that means we shouldn’t take them either. Or we should take them in a more controlled manner.

Explanations are needed, of course, but it’s very good if this is made clear with the FDA and avoiding pitfalls is considered. CR could potentially become the sole endpoint, especially if its duration is long. So far, it looks okay. Juho takes the FDA’s lines for solid tumors as an example: CR and PFS, i.e., progression-free survival (cancer progresses or the patient dies).

Juho says at 14:20: “we will do phase 2 part unblind.” Same thing in the Inderes interview, that data is obtained for business purposes, which likely means a partner is interested in which direction the data starts pointing, i.e., derisking. As a patient knowing you’re on placebo, it wouldn’t be nice, though they do have aza. In the Q&A, he says they could do it unblind as a cost-saving measure, i.e., open-label, and they could then continuously monitor the data to see how each group is performing.

Phase 3 would be 100 million, but they are not going there.

P.S. I watched the video at 2x speed, and the “old CEO” came out instead of that new, calm one.

28 Likes

Speculations about a major pharmaceutical company’s involvement are not just a “speculative added spice”; they are currently the most critical engine of Faron’s value creation. In biotechnology, this situation is often called “partnering expectation,” and it determines the share price more than any other single factor.

The company’s value is theoretical until Big Pharma (BP) enters the picture. This is when science turns into money. BP certainly has the world’s best experts to evaluate clinical data. Without BP speculation, would Faron’s pricing be based solely on its cash position and a slim chance of survival?

Speculatively, BP brings a billion-euro valuation into the mix. So far, it remains unclear to us laypeople how and which BPs are monitoring Faron’s progress. BP acts as a form of guarantee for Faron; as long as medical results are good, BP interest remains.

Further speculation: Will Faron’s management manage to agree on a BP partnership before the €40M offering wrecks the old per-share value – i.e., before March 2, 2026? The share price reaction would certainly be significant.

Faron – a speculative play

10 Likes

I was referring to the speculation that some Big Pharma (BP) company would corner a position in this turmoil and buy out the rest of the shares. Speculating about partnering is, of course, meaningful. And in my view, the cards have been clearly laid on the table: partnering will be revisited once data from the peer-reviewed Phase 2 study has been produced at the end of 2027. Everything else is just a thought experiment that isn’t worth basing investment decisions on. (You can, of course, base them on it if you want).

1 Like