Handelsbanken’s share count decreased by 260,000 in February.
Edit: I had mistakenly looked at those Aldert reductions. My apologies.
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Huh, I missed scrutinizing this slide more closely when I looked at the Q4/2025 report. A similar slide dated December 16, 2025 (https://www.nanoform.com/en/wp-content/uploads/sites/2/2025/12/Nanoform-Capital-Markets-Day-December-16th-2025-Helsinki.pdf) still showed enzalutamide entering the market in the US in 2027 and in Europe in ‘28. My understanding was that nanoenzalutamide would be the spearhead for incoming cash flow starting in 2027.
I find it a bit confusing why the delay (or even cancellation?) of the US 2027 product launch hasn’t been communicated more clearly by the company management. Does anyone have any speculation on whether this is possibly due to the Trump administration or some other factor?
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My guess is that partnering negotiations are still ongoing for some reason. These haven’t been updated recently, but here is the 2025 H1 update on the situation at that time. At that stage, the only market for which an agreement had already been signed was Germany.
edit: I dug a bit more into the Astellas report. I found this small print regarding Xtandi.
Global sales expected to be the similar level YoY (excl. Fx impact), with growth of ex-US markets mitigating the negative impact of U.S. Medicare Part D redesign
So, the Medicare Part D redesign affects the sales price of Xtandi in the U.S. This likely also slows down the agreement on sales and distribution terms for nanoenzalutamide in the U.S. Milestone payments are probably tied to sales targets, but if there is still uncertainty regarding the sales price, the agreement on those milestones could be delayed.
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18 buy-rated stocks on the Helsinki Stock Exchange – Analysts would snap up four small-cap stocks Helsingin pörssissä on 18 ostopaperia – Analyytikot hamstraisivat neljää pienyhtiön osaketta | Kauppalehti
Apparently yesterday’s rally was due to this news.
“Nanoform average target price €2.5 from three analysts”
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The Board is also participating in the collective effort
“The proposed fees are 20% lower than in the previous term. Additionally, it is proposed that no fee be paid to a board member who has an employment relationship with the company.”
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Inside information: Feedback from European Scientific Advice Meeting with Reference Member State Will Delay Submission of European Marketing Authorization Application Planned Initially for May 2026
Following the meeting, the authority acknowledged the strong scientific rationale and high-quality standards for the product and the supporting data package. Current legal and regulatory requirements do not allow a hybrid generic application for nanoenzalutamide in its present form, as full compliance with all bioequivalence criteria is mandatory. Consequently, the authority advised evaluating alternative legal bases (regulatory pathway and filing type) and clarified the criteria under which nanoenzalutamide is eligible to proceed via a generic approval pathway.
Acknowledging the competent authority’s advice, Nanoform and its partners are currently evaluating several available regulatory options that would enable European approval while aiming to minimize any potential delays. As a result, the previously planned dossier submission slot in May cannot be met. Decisions based on the evaluation of the scientific advice will be taken jointly with the commercial partners for nanoenzalutamide. Updated timelines will be communicated once a final strategy has been agreed and will be provided in the 1Q quarterly report on May 19th.
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Here’s the announcement,
is it rubbish coated with beautiful words?
Inside information: Feedback from European Scientific Advice Meeting with Reference Member State Will Delay Submission of European Marketing Authorization Application Planned Initially for May 2026 Inside information: Feedback from European Scientific Advice Meeting with Reference Member State Will Delay Submission of European Marketing Authorization Application Planned Initially for May 2026
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That’s a real shame. But it probably doesn’t come as a complete surprise, because if Cmax isn’t between 80%-125% of the original, it’s not within that range… What’s next then, a non-inferiority study? How much will that cost, is there enough cash?
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Was this already known? Oh dear, a screw-up if it was. If a generic route is not available, things get much more difficult. A full application requires much larger studies… The partner may withdraw from the project now if the nanoformulation’s value add is not attractive enough to justify more expensive studies…
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What has been stated is that the fasting AUC was within that range and Cmax remained a bit low (last summer). I don’t quite remember how much information on the fed-state study was shared with the public during the last earnings report; I did glance at it, but I haven’t been following it closely now that I no longer own shares. The stock price will probably drop quite a bit, as the first cash-flow positive years likely have been postponed, and the cash probably won’t last for such long/expensive studies without additional funding. But then, the long game that jerej has been hyping up will open: these nanoformulated subcutaneous biological drugs, which I, too, have seen as creating added value through more than just patent maneuvering. Perhaps the game will open up for a long time and from attractive price levels?
Well, this kind of contraption is now what we’re facing. Will it now get hung up because of that Cmax? I dug up some enzalutamide food effect data from here. Here, Cmax decreases between fasted and fed states to below the 0.80-1.25 range.
Additionally, a quote from the article, with my added bolding.
The geometric mean C max was approximately 30 % lower and median t max was approximately 1 h later with food. The 90 % CI for the ratio of treatment mean C max values was 0.63–0.78, which is below the 0.80–1.25 range to establish absence of a food effect. Taken together, the results show that there was a negligible change in AUC and a slightly lower C max when enzalutamide was taken after a high-fat meal. These C max changes are not considered clinically relevant.
Anyway, the question now seems to be, what kind of experiments can move this application forward, how long will it take, and how much money will it require? How much does the progress of the enzalutamide project affect the milestone payments tied to it? The current cash reserves seem to be enough for about 2 years at the current burn rate.
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But do I not understand correctly that the fasted state Cmax of nano-enzalutamide is compared to the fasted state Cmax of enzalutamide, and it must be between 80-125% for generic approval? And not that the fasted state Cmax of nano-enzalutamide should be between 80-125% of the fed-state value of enzalutamide for this approach to work?
Now it was said that this announcement only concerns Europe, other plans have not changed.
But about those other plans, especially in the US, there has been a lot of silence lately, and the focus has been on the European approval pathway and timeline…
Yes, that’s how I understand it too. It goes by the definitions of bioequivalence, where all of those should be within the reference values. The peculiar thing is that the higher peak must match the reference, even though there’s probably no biological difference if both fed and fasted states work in the reference drug. Now, larger trials are likely needed to show that this has no significance. It will be costly and slow down the process, but the probability of success for that trial is almost certain.
The time passing is bad due to the patent window. It would be important for nanoenzalutamide to enter the market during the period when the active ingredient’s patent has expired, but the ASD formulation’s patent is still in effect. This reduces competition when market share needs to be captured. In a previous quarterly report, management stated that these potentially required larger trials could still be completed before the 2028 patent expiration, so commercialization would not be significantly delayed. Well, with the Q1 report in May, we should get more information from management on how this process will be moved forward.
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Management buying, as they should at this price, if they have faith in the product. Market cap only €37 million, even though no catastrophic news has emerged and things are moving forward despite small setbacks.
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I would be very surprised if management hadn’t already considered an alternative in case the marketing authorization application for nanoenzalutamide gets stuck on that bioequivalence issue and the Cmax differences.
One possible alternative to those more expensive non-inferiority trials could be to formulate the drug pill so that it releases the active substance faster initially. The pill itself consists of enzalutamide nanocrystals embedded in a polymer. Faster initial dissolution could potentially be achieved by modifying the properties of that polymer*. This way, the pharmacokinetic properties of the reference drug could perhaps be better replicated, and the application could still be approved according to bioequivalence specifications. But we will hear more about this only next month.
* edit: Or the dissolution is affected by either the polymer’s or the nanocrystals’ properties, depending on whether the initial dissolution is limited by the polymer’s degradation or the dissolution of the crystals. If the size of those crystals can be controlled, as Nanoform advertises, the initial dissolution could be accelerated by adding smaller crystals to the pill.
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From a column in Kauppalehti, one writer had called Nanofirm’s IR director and asked about these Cmax issues. Apparently, the problem has been Cmax exceedance in the fed state.
“I looked into the matter and it’s about Cmax exceedance in the fed state, i.e., after a meal. This is because the original Xtandi/Enzalutamide tends to have a significantly larger drop in drug concentration after a meal than Nanoenzalutamide, and this causes the exceedance.”
If I remember correctly, in fasted trials, Cmax had previously been low compared to the reference, and now it’s apparently high compared to the reference in the fed state. The Cmax of nanoenzalutamide should then fall somewhere between the reference values and be independent of eating. Theoretically, this could even be better than the reference, as the drug concentration doesn’t fluctuate as much. Now the only open question is how to get this through the EMA’s gauntlet most easily?
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Owner list updated on the pages today. Handelsbanken funds -1.48M shares. Only 1M shares left.
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Isn’t Nanoform’s AGM on April 21st and not tomorrow as shown in Inderes’ stock market calendar?
21st is correct, source: official investor calendar nanoform
Another interesting comment from the Kauppalehti forum.
“I found out that Handelsbanken’s massive holding was once the responsibility of two fund portfolio managers; one bought at the IPO and the other sometime in 2024. The latter is holding roughly the current Handen (Handelsbanken) ownership. The first one left the position and was replaced by two others, who then for one reason or another have dumped everything…”
I wonder if Handelsbanken’s sales are finally over? 
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