I disagree with this a bit. This is such an important study that the company must publish the results without delay once they receive the results themselves. The study is being conducted by a third party, and Nanoform presumably should not know the result until the final study results are reported to them. The results are, of course, about a month late; perhaps someone more knowledgeable can say how typical one-month delays are in medical studies.
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Didn’t those results last time (fastes state) come out with the Q2 interim report? Or am I remembering wrong? I feel like exciting results have been shared via press releases, while lukewarm ones like these country-specific partnerships come out with the interim reports…
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True, that’s how it was—the results were provided in connection with the earnings report. Perhaps it is possible that the results are already known but won’t be published until the Q4 report. However, I find that a bit strange from both a regulatory and company communication perspective, if they have the final results but aren’t releasing them to the market. 1) This is significant inside information regarding the company’s value, as a successful study result means it is very likely that nanoenzalutamide will indeed reach the market. This is also the final proof of the technology’s functionality. 2) Why would the company state that the results are coming at the end of the year if they didn’t intend to publish them before the Q4 report?
Hopefully, we will get answers to these questions soon.
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“As a result of the negotiations, 49 employees will be terminated. In addition, temporary part-time layoffs may be implemented for a portion of the remaining personnel in Finland starting from March 1, 2026. The duration of the layoffs can be a maximum of 6 months. Through these measures, the company expects to achieve cost savings of approximately EUR 5–6 million for the 2026 calendar year.”
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Now that’s some good mini-
news, by the way. If that SC Nanotrastuzumab provides AUC, Cmax, and Tmax values in pigs equivalent to Herceptin HYLECTA, I would proceed with the assumption that there is also reason to expect similar results in humans. Now, I suppose it’s a matter of the timeline for bringing the production line up to GMP standards and when human trials can begin.
Here are Halozyme’s projections for the revenues of those acquired Hypercon methods for reference (copied from the Halozyme presentation here).
I also checked to see who is currently selling this, and Handelsbanken, Danske, and S-Pankki were the largest sellers in January. S-Pankki has now dropped off the top 25 list.
edit: I’ll add this regarding the trastuzumab market. https://www.polarismarketresearch.com/industry-analysis/herceptin-biosimilars-market
" The Herceptin Biosimilars market size was valued at USD 2,711.22 million in 2024. The market is projected to grow from USD 3,325.31 million in 2025 to USD 21,271.43 million by 2034, exhibiting a CAGR of 22.9% during 2025–2034."
And of course, if this works with one antibody, the next good candidate could be Pembrolizumab, whose patent expiration deadline is in 2028. Pembro’s annual sales are currently around 30 billion USD.
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The company could certainly communicate a bit more promptly and clearly how things are progressing with nanoenzalutamide. After all, it is a very important matter in the minds of investors, as near-future cash flow assumptions and financing needs are so strongly linked to this. Silence doesn’t help; judging by the share price, as the silence continues, more and more investors don’t dare to carry the risk? They really should communicate where things stand…
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Probably more info next Thursday. It’s possible we’ll slowly drift downwards until then, as biotech firms on the Helsinki exchange have been sold off quite heavily recently.
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No big surprises at first glance. The train keeps chugging along. “The fed study results support the previous fasted results and Nanoform and the ONConcept® consortium’s assessment is that the results are supportive for nanoenzalutamide to progress to the markets underpinned by an adjusted regulatory strategy.”
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At a quick glance, the company has set a target for cash burn below €10M for 2026 and is aiming for 50% revenue growth – but only 5% growth in expenses. A turnaround could occur in H1 2026 if expenses remain steady, but revenue starts rising toward €5-10M/quarter.
Clinical manufacturing brings in recurring income, not research activities. As I understand it, the market launch for the lead product, a prostate cancer drug, is targeted for 2028, so there is still time until then.
The company has been around for a while; could 2026 be some kind of breakout year that would be reflected in valuation growth? When will the moment of credibility for scalable revenue arrive?
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One shouldn’t let the growth percentages mislead them too much. In my opinion, the company hasn’t been in such an uncertain situation during its time as a listed company. The €3.5 million revenue consisted of 53 projects, so there is still plenty of buzz on the R&D side, but the projects are very small and none of them have yet converted to production during its history on the stock exchange.
One’s understanding must be built largely on isolated scraps of information, and I believe the layoffs carry significant informational value. It is true that during a phase of aggressive ramp-up, there can be hiring mistakes and a need for structural changes, but anyone can consider what startup voluntarily lays off 30% of its employees and furloughs the rest if things are going according to plan (as the company has mainly communicated), especially when the core of the previous strategy was increasing headcount! In the financial statement, the CEO blamed defense industry investments for the scarce investments in drug development, but those R&D projects are still ongoing as before. Why hasn’t any of these dozens/hundreds of projects progressed all the way to the market?
To an outsider, it looks like after the major layoffs, the focus is even more on R&D projects and production is further away than ever. One can only imagine what the retention rate of the furloughed staff will be, assuming the furloughs affect the production side, where there is likely skilled personnel for whom there is demand among competitors as well.
Props, however, for trying and making difficult decisions (YT), but it is good for investors to consider a sufficient risk premium in the case of this company.
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Everything has its time, as the saying goes. There was some discussion earlier about how, once the development of a product or prototype has progressed far enough, the same team is no longer needed for the next phase for a while. This would serve as a good explanation for those job terminations. However, they seem to have been in permanent positions rather than being precarious gig workers.
I actually didn’t know there were that many research groups and, consequently, internal startups within Nano, and that the company isn’t just dependent on the launch of one or a few strong products. Some kind of limit must have been reached if the expertise of those laid off cannot be utilized in new projects or those in earlier stages of development. Has the demand and potential for that expertise simply run out?
Have you, Jerej and others, had time to watch/listen to the investor call yet?
I listened today while driving; I couldn’t watch the slides then.
What was exciting, and what jerej has told us before, is this potential of nanoformulation in s.c. (subcutaneous) biological drugs. The positive results of the pig study and Takeda’s descriptions of how nicely the material behaves in injection needles.
But did I miss something, or was nothing else said about the nanoenzalutamide human trials other than that fasted and fed states have now been studied, they are working on submitting the marketing authorization application (apparently only EMA at this stage?) in Q2 with an ”adjusted” strategy (or whatever the wording was), and they are aiming for sales to start in Europe in summer 2028. Is there no talk of the USA anymore? Partners have been secured in a few EU countries (was it 5 now?) and in one non-EU country.
This nanoenzalutamide section is very vague and slow-developing; we are being kept on very scarce communication.
Nanoenzalutamide is linked here to the considerations of the company’s financing situation in the coming years. There was 24 or 26 million in cash left. They are aiming for an annual burn of less than 10 million this year. Apparently, there still hasn’t been any (revenue-generating) GMP activity from outside the kernels? Non-GMP produces peanuts. To remain a credible supplier, the company cannot let the cash run to zero; there are almost 2.5 years until nanoenzalutamide sales begin, and there have been suspicions here that it will start slowly regardless.
Peter answered regarding a possible GMP line for biologics—once the decision to start is made, it takes about 24 months to reach production.
It feels like the company’s financial situation is starting to look quite worrying on a 2–3 year horizon, and capital might have to be sought at a valuation that is unfortunately low for current owners?
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I listened to that webcast yesterday. I’ll share my thoughts over the weekend. According to the CEO, the cash burn estimate for this year (approx. -€10M) does not include milestone payments. Management likely doesn’t want to forecast them for this year as their timing is probably uncertain, but if they do materialize, the results should primarily shift upwards. The submission of the marketing authorization application for nanoenzalutamide is still expected to happen this year. If it gets delayed, the company’s financing situation will indeed become more difficult. However, at the current cash burn rate, the cash runway should last for another two years. I would assume that the milestone payments for nanoenzalutamide are also tied to obtaining that marketing authorization.
The income from associated companies (gray bar) likely comes from BRAFmed’s signing fees. According to management, these are in the low single-digit million range, which would fit that figure. The black bars likely relate mostly to nanoenzalutamide, of which Nanoform owns 25%.
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Handelsbanken funds was still the largest shareholder last summer with over 6 million shares. Now just over 3 million remain.
The question is: are these sales because S-Bank bought Handelsbanken’s Finnish operations? I had been pondering if it was something bigger, but then I remembered that deal. It makes me feel a bit better about the company—and after all, you’re happy at the grocery store too when you get a pack of coffee for cheap.
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This company is tricky to evaluate in the short term, as such a large portion of its potential depends on projects conducted with customers, about which not much can be disclosed externally yet for understandable reasons. If information were available regarding, for example, the distribution of the clinical phases of the projects’ drug substances, it would already help in assessing them. A preclinical stage candidate is much riskier than, for instance, an already approved drug whose properties are intended to be improved through nanoformulation. Currently, assessments must primarily rely only on the already published internal product kernels, which, however, underestimates the potential in the long term.
Here is that product kernel list from the presentation slides:
Of these, nanoenzalutamide is currently the furthest along, and its path forward is the clearest. A marketing authorization application should be submitted for this during this year, and the next milestone payments will likely be related to that. If this materializes, it could potentially turn the result positive next year, but it will likely require the regulatory authorities to accept the difference in Cmax compared to the reference drug.
Next on the list is nanoapalutamide, the first GMP batch of which was produced in December according to the press release. In that list, the partnering status is marked as ongoing. If this deal is finalized, some upfront payment could potentially be expected as early as this year, but perhaps it’s better to expect it to fall into next year. However, something that might complicate matters and slow down the deal-making is the inclusion of apalutamide on the list of discounted drugs (the Trump-era list), which would lower its sales potential.
GMP production for nanoencorafenib is also planned to start this year, and the first clinical trials for both this and nanoapalutamide are also intended to be launched this year.
Additionally, the inflammation undisclosed kernel stands out on that list, with its development partner status marked as partnered. We might hear something about this next.
In the longer term, the question of nanoformulating biological compounds is very interesting regarding the company’s potential. Here is a picture from the CMD (Capital Markets Day) slides showing the share of biological compounds in the pharmaceutical market.
We are now moving into a situation where the market for biological compounds already accounts for a larger share than more traditional small-molecule compounds. Therefore, in my opinion, the production capacity and GMP status of the bio-line/lines are significant drivers towards the end of this strategy period. For this reason, I will perhaps pay even more attention to the progress of these biomolecules.
Regarding that previous pig study, it wasn’t just Nanoform’s trastuzumab tested in vivo, but also a nanoformulated biomolecule from a partner.
The best guess at this point is probably Takeda’s alpha-1 antitrypsin, as it has already been named elsewhere before, but it could certainly be another compound as well, such as another monoclonal antibody.
In that response, he also mentioned that the conversion of the bio-line to GMP level will be done at the partner’s expense, meaning there will be no separate costs for the company. Negotiations on this are still ongoing, however. Assuming negotiations are concluded during this year and it takes about 24 months to reach GMP status, a GMP bio-line could be operational sometime around '29.
We are now entering a phase where the initial investments have been made and cash flow should be turned positive. In my opinion, this is possible by 2027, but it will likely still depend on growing payments from partnering deals during this five-year period. Sales royalties are likely to have a relatively small impact for now, as sales of nanoenzalutamide can start in 2028 at the earliest, and even then, it will take time to reach its full potential.
The company’s own estimates of its potential at the end of 2030 can be found toward the end of the slides. If these are realized, the situation will eventually turn around, but there’s always that eternal underlying question of whether one should listen to company CEOs. 
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Thank you Jerej for your comprehensive and thoughtfully reflective response. I need to read this carefully at a suitable moment, and also listen to the webcast while following the slides. There is information there, after all.
The situation would be so much nicer if the cash position were flush and investments in biologics could be made independently (or rather, there’s no problem if they’re done with others’ money, as long as things progress relatively without delay and actually move forward).
It’s a shame that more capital wasn’t raised at a better share price level (although the current slide in the share price seemed to start from that previous directed share issue). But hindsight is easy; the company likely hoped for an easier and more lucrative case with nanoenzalutamide. Even around the three-euro mark, management was buying shares…
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This sums up the case quite well at the moment. Personally, I’m still quite optimistic about this. At least so far, everything seems to be progressing, though maybe two years behind what was originally thought. Perhaps many others have invested here with a shorter-term view, but I’m mainly following how the turnaround toward 2027 progresses. Until then, I can gradually add to my position from these fund sell-offs. Falling knives, etc. 
In my opinion, 2026 is a bit of a transition year, and more of those milestone payments will likely hit in 2027. During this year, however, more information should be released about those other kernels. Quite a few of them are marked with ‘development partnering’ status for 2026 in the table above. These are the ones that should then carry the company forward at the end of the strategy period.
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At least for the executives, one would think there’s motivation again, since news just came out that they’ve redeemed their free stock options.
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That’s just it, but that’s why I put my chips in—you have to try and fish for the bottom.