Previously, marketing authorization was required from two reference countries (e.g., USA and EU) before Hong Kong would even consider the matter. Now, marketing authorization from one reference country + local clinical data/expert assessment is sufficient.
If this mechanism is used, Nextcell could quickly obtain marketing authorization in Hong Kong after Western trials are completed. For example, Amgen received accelerated approval from the FDA for the drug Imdelltra in May 2024. They immediately utilized the Hong Kong 1+ pathway, bringing the drug to Hong Kong hospitals just a few months after the US launch.
2. GBA shortcut (Greater Bay Area)
This is likely the biggest thing NextCell is aiming for.
Drugs approved for use in Hong Kong can be used in certain large hospitals on the Mainland China side (Greater Bay Area), even if they do not yet have national Chinese (NMPA) marketing authorization → this allows the collection of “Real World Data” from paying patients in China significantly earlier.
Phase 3 reduction? Chinese authorities apparently often accept this “Real World Data” as part of the final marketing authorization application. It can radically reduce the size and cost of the actual required Phase 3 trial.
3. Bridging Studies
In China and Asia, a full Phase 3 trial starting from scratch is not always required if Western data already exists. Instead of conducting a new massive 500-patient trial, Hong Kong/China may accept a so-called “Bridging Study” model. This involves a smaller, cheaper study to simply ensure that the drug works in Asian patients the same way it does in Westerners.
With a little research, for instance, the Chinese drug Fucaso was approved and received marketing authorization in China in 2023 based on a small Chinese Phase 1b/2 study. The authorization was thus granted conditionally without Phase 3, based on Orphan Drug status and a good response. Last year, based on this Chinese reference study, it also received marketing authorization in Hong Kong. It seems Nextcell’s path would be in the opposite direction. Some level of study is required in Hong Kong or China, but it could be significantly lighter than a Western Phase 3.
Very interesting research, which may well provide an explanation for Nextcell’s expansion into the East. Among the Chinese population, the incidence of T1D is significantly lower than in Western countries, at 3.6/100,000 per year, but within Hong Kong’s population base, this equates to 250 new cases annually. This would certainly be sufficient for conducting a study.
The stem cell therapy business is growing and of interest to investors. According to one estimate, the volume in the US will grow from $14 billion in 2023 to $49 billion by 2033, with a CAGR of 13%.
ProTrans-Repeat (7-year follow-up) results are now out! These were promised “shortly,” but I thought we wouldn’t see them until closer to summer.
In practice, the results are excellent, but at the same time, I have to remind you that the sample size is almost negligible. The original study was designed for 18 people including a control, and after 7 years, it is difficult to get everyone to participate annually. It is encouraging, however, that the effect seems to be “dose dependent,” meaning it increases as the dose increases.
The fact that the effect is still visible over 7 years after the first dose and for some, insulin production is near baseline levels, is a really, really good result: in practice, the probability of that happening with a regular T1D patient is very small. Usually, at the diagnosis stage, the autoimmune reaction is already very advanced, and after 7 years, insulin production is practically non-existent. Despite the small sample size, these results also speak to the efficacy of Protrans.
As a small critique, we don’t know what the baseline insulin production level was at the start of the study. If it was already negligibly low, the “same level” after 7 years might not be as good as it sounds.
The end of the press release describes the commercialization goals:
Based on the strength and durability of the clinical effect observed after a single infusion, NextCell’s primary objective is to bring ProTrans to patients as a single-infusion treatment, where the Company’s data is most extensive, and to pursue market approval on this basis.
In Finnish: Although the repeated dose seems to work, Nextcell aims to enter the market through a single dose first, as it is regulatorily easier and cheaper. Repeated treatments offer growth opportunities for later stages.
Following market approval, NextCell intends to extend its label with the addition of paediatric patients. The Company will also explore the possibility to further optimise the treatment regimen by evaluating repeated ProTrans infusions as a strategy to maximise and prolong the therapeutic effect in selected patient populations.
But wait a minute! Did Nextcell just radically change its strategy?
Previously, Phase 3 was intended to include a wide age distribution, which is why the “young” results must be awaited before Phase 3. According to the CEO’s Q&A section, this was also the EMA’s wish.
Now there is talk that “After obtaining market approval, NextCell intends to extend the market approval to also cover pediatric patients.”
Isn’t this in conflict with the previous statement? I think there is a good explanation for this: market approval is being sought first in Hong Kong or China, where it has been proven that conditional market approval could be obtained already with Phase 2 results.
‘The Chief Executive’s 2025 Policy Address’ announced that the Government will set up the Hong Kong Centre for Medical Products Regulation (CMPR) in 2026, and implement the ‘primary evaluation’ mechanism for new drug registration in phases starting from that year, enabling Hong Kong to independently assess and approve the safety and efficacy of medical products based on clinical data’
Recently, Nextcell even visited the Hong Kong embassy. Could it be that Nextcell is one of the first pilots for Hong Kong’s newly established CMPR?
If true: an interesting question is, could it be possible that Nextcell does not need to separately demonstrate the drug’s efficacy in the local population? And could Nextcell receive “orphan drug” status from the Hong Kong authority, which would allow it to apply for market approval with Phase 2 evidence, as was done in the case of the drug Fucaso? In that case, the first market approval could be very close indeed.
Apologies for the self-replying; I try to avoid excessive walls of text and separate different topics into different posts.
I recently realized that the real breakthrough for Nextcell might lie in this:
Regarding the phased implementation of “primary evaluation”, the initial phases will cover applications for the registration of products containing registered chemical entities with extended applications (e.g. new indications, new strengths, new posology, new dosage forms, etc).
At this point, let me remind you: Protrans is not strictly a new drug or a new drug substance. It is based on a patented new way to select, process, and use MSCs (Mesenchymal Stem Cells).
If the MSC cell is already considered a “known biological component,” NextCell could perhaps apply for ProTrans as a new indication (the previously mentioned “new Indication”). In theory, if the Phase 2 adult data were deemed sufficient, this would enable a conditional marketing authorization application among the very first as early as 2026.
Disclaimer: This message contains a great deal of enthusiasm-fueled speculation, so I warn against taking it too seriously. No Western drug has ever received its first approval in HK, so it would be quite a historic event for the entire biotech scene if this were to happen. I also don’t actually know if the criteria applied by the Hong Kong drug regulatory authority in its own approval process are any easier than in the West.
Good vibes in the air. The stock ended up 21% yesterday, and today it’s already up +6% on the board.
@Clark_kent and other professionals: Could we hear your views on my Hong Kong hypothesis, which I’ll outline as follows:
“Hypothesis: Nextcell aims to apply for a first drug approval based on Phase 2 adult data through Hong Kong’s recently launched primary evaluation track. It seeks to leverage the established position of MSC products and applies for approval primarily under a “new indication” interpretation, which would enable a marketing authorization application for the adult population using existing data. In Hong Kong, a partner is certainly needed, for example, to license the local and Chinese markets.”
One stumbling block for this hypothesis is that, as far as we know, there is no actual commercial approval for MSC stem cell therapies in HK yet that Nextcell could reference. Perhaps that’s not necessary, though, because MSC stem cells are otherwise so extensively studied, and it’s not a chemical drug.
Secondary Hypothesis: Nextcell aims to find an Asian partner to establish a local laboratory under a holding company in Hong Kong’s new biotech scene. Locally, they would start Phase 3, which, however, would be significantly lighter, faster, and cheaper than in the West. This would allow them to seek first drug approval through Hong Kong’s recently launched primary evaluation track faster than in Western countries.
The stumbling block for this hypothesis is that it doesn’t explain why they would talk about seeking marketing authorization first for the adult population only, when the results for young people are just six months away. What is so critical that they can’t wait half a year if they’re facing a time-consuming and labor-intensive Phase 3 and approval process requiring financial investment?
One possibility, of course, is that Nextcell perceives its “big brother” Diamyd as a threat to its own business potential, as Diamyd could reach the market soon with Stage 3 treatment. Furthermore, it has a strategic lead in Stage 0–2 treatments. If treatment responses, costs, and prices are on the same level, Diamyd could take the whole game in the West. One could also think that an aggressive focus on Asia using “fast tracks” is the best chance for long-term commercial success.
It is also possible that Nextcell has not succeeded in finding a partner in the West and feels it is necessary to rush a marketing agreement before Diamyd’s results are released and potentially lower Nextcell’s chances, hence the hurry to try for Hong Kong.
Since “Primary Evaluation” is a goal declared at the HK government level, it surely has a far-reaching strategic purpose. I would assume it relates to the Northern Metropolis plan, at the heart of which is specifically a biotechnology and high-tech cluster. For instance, it has invested 10 billion in InnoHK Research clusters, one of which relates specifically to biotech and where it has sought to attract laboratories from MIT and Stanford. Additionally, it is building the massive Hong Kong-Shenzhen Innovation and Technology Park, where a special life sciences and health technology hub will be established, focusing specifically on drug development, genomics, and cell therapies.
It would seem that Hong Kong is trying to attract foreign companies and create an advanced medicine business hub. There is, of course, a high risk that intellectual property and trade secrets might leak “under the table”. To offset that risk, Hong Kong must offer significant benefits to companies. My gut feeling is that it consists of two factors:
The previously mentioned fast, limited access to the Mainland China market. This has existed before if approval was obtained from another country’s drug authority. It was previously facilitated by the “+1 mechanism”.
Now, Hong Kong, with 7.5 million inhabitants, is establishing its own drug authority. Why? Because it wants to be the entity that can grant the world’s first approval, thereby attracting companies. How do they achieve this? By offering a shortcut to success—meaning significantly easier first approval for selected firms compared to what Western countries offer. This could mean smaller and shorter sample sizes, higher tolerance for complications, faster processes, and, for example, acceptance of Phase 2 data on a broader scale, if treatment response and safety are tolerable.
Hong Kong does follow, at least on paper, internationally accepted ICH standards regarding clinical data, and at least on paper, it also wants to make its drug authority internationally recognized. So, it’s unlikely to be a total “Wild West” there. But drug authorities do have a lot of their own discretion regarding conditional marketing authorizations. Thus, even while following international standards, it is possible to lower the barrier significantly by interpreting the grounds for conditional marketing authorizations more freely.
Even though things in the US might be easing slightly, Europe and the US emphasize certainty and safety and love bureaucracy more than the East, which forces early-stage companies to the door of Big Pharma, hat in hand, by Phase 3 at the latest, as it easily requires hundreds of millions in investment with uncertain results. At the same time, the majority of future cash flows are given to pharmaceutical giants in return. There would certainly be demand for a light regulatory path.
If the currently uncertain hypotheses above prove to be true, Nextcell could be in an interesting position among the first applicants. Surely, the Hong Kong authorities also have an incentive to show successful success stories from their strategic project.
I think that your thoughts on Nextcell’s potential projects in Hong Kong, which might have seemed a bit high-flying at first, could actually progress.
Aktiespararna organized a Life Science theme evening on 26.1.26, where Nextcell’s plans for the Far East were outlined. The idea is to combine Nextcell’s expertise with Hong Kong’s developing infrastructure in the field.
From Nextcell’s side, its cell bank expertise and MCB (master cell bank) operations would also be included.
Under the local joint venture partner, the slide listed mentions of, among other things, local production, direct sales (estimated potential pre-market market value 30M USD/year, apparently in Hong Kong), pivotal phase II trial, single CT for approval, and distribution.
The CEO mentioned expanding operations to mainland China as one possibility.
Interesting plans.
Hong Kong has built up several eh systems and organizations to help foreign companies enter the Chinese market. It is an extremely capital-rich and we see good opportunities to eh together with local investors and eh companies be able to conduct a clinical trial to treat type one diabetes in Hong Kong and then spread it to the greater part of China.
Eh the setup is like this that Nexel has eh IP, we have knowhow, we have the entire clinical trial package and we eh now need a partner in the area to finance the study.
“A phase two study is enough to get approved in Hong Kong.”
“So that it is simply a way to save it, yes, in Europe we are actively working on Pro Trans Young. In the US we are waiting until we have our Pro Trans Young study. It is possible that we can even get conditional approval in Europe for it , and then we want to start a bridging study in the US instead of starting a phase three study. So that it is a way to work more cost-effectively without selling anything.”
We have eh we have already started a holding company in Hong Kong. It’s called Nexel Hong Kong.
Eh, and the idea is to transfer the rights from Nextcell Pharma to this holding company for Hong Kong and China and that you then eh do it together with a local partner.
I interpret this to mean that they are trying for conditional market entry with Phase 2 data, but it requires that funding for the Phase 3 implementation is in place, for which a partner is needed. Conditional (early) marketing authorization in Europe is also considered a possibility.
How do fellow investors see NextCell’s chances of avoiding another share issue before the results for the youth study? And what will the market reaction be if NextCell succeeds during 2026?
-NextCell had 38.7 MSEK at the end of August 2025.
-It consumes about 8–9 MSEK per quarter.
-In February 2026, a 15M SEK directed share issue.
-However, in the offering “demand clearly exceeded supply” and the company deliberately kept the size of the issue small. Additionally, the proceeds were announced to be directed towards the Hong Kong operation.
-According to the CEO, “At the same time, the issue is deliberately sized to give the company peace of mind for upcoming value-driving milestones, without burdening the ownership base with unnecessary dilution.”
With the same burn rate, the cash would have been empty by August 2026. With the additional 15M subscription, time was bought until the end of the year. However, Qvancella already has revenue, with the first insight expected at the end of the month, and it will be able to operate more extensively once the GMP license is obtained. Plus Fujifilm and other partnerships on top of that.
Two options:
A) The company needs a share issue, but it is postponing it, waiting for a significantly better share price driven by upcoming catalysts.
B) The company doesn’t need a share issue because the relatively low costs can be largely covered by new business during 2026.
The main reason for the low share price is likely dilution expectations. If the business proves it can cover its costs, the stock turns into a value-preserving lottery ticket primarily for Phase 2 results and partnership deals. What would be a fair valuation then?
Interesting questions that I have also been pondering.
Is the internal funding from Cellaviva and Qvance etc. sufficient? I remember the CEO stating in some presentation that Qvance would reach profitability by the end of the current year. Cell and tissue sales haven’t grown very quickly in recent years. The Fujifilm collaboration is a wild card that could involve income. All in all, I am slightly skeptical that the internal funding from these operations would suffice for very long, considering the upcoming needs.
Funding will be needed after the Phase 2 interim readout (if successful) for presenting results in various ways, negotiations with regulators (in the East and West?), planning follow-up studies, and partner negotiations. A beggar’s position is still that of a beggar.
This is indeed one reason for Nextcell’s discounted market cap state, as you have noted. The dilution risk is high. I agree that the small dilution in the winter was wise; it ensured progress until the end of the year.
What is the share’s value after the interim readout?
I am optimistic about the success of that readout based on previous trial results. According to the CEO, the readout covers—as I understood it—both groups. For the older group, where the honeymoon effect lasts longer, the results are already 24 months old. For the younger group, where the duration of the effect is shorter, the readout occurs at the 12-month mark. One would think the difference would already become apparent.
One starting point for the investment decision is the share’s low price relative to the company’s potential. This has materialized for Nextcell, but it has brought a problem. The market cap is so low that even a large offering doesn’t yield much relative to future needs.
Hard to estimate the share price after the readout—optimistically 5+ SEK? Market psychology can play a role. Diamyd’s successful Phase 3 and its possible follow-up actions could provide a tailwind for Nextcell.
However, early partnering would be important after the summer. For Diamyd, 170 patients are apparently enough for Phase 3. I haven’t looked into the costs of this phase, but in diabetes, they are likely not as high as on average in Phase 3 trials ($100,000 per subject). This likely lowers the threshold for partnering.
I remember the CEO stating in some presentation that Qvance would reach profitability by the end of the current year.
Are you referring to this interview with the CEO of Qvance?
The interview was done 4 months ago. At that time, Lindsay said that services had been offered for 2 months, revenue is already being generated, there is a very long list of waiting customers, and “breakeven is just around the corner”.
I also remember another reference to Qvance’s earning potential from the parent company’s CEO, but I can’t find it right now.
One problem here is that the quarterly reports do not break down expenses by subsidiary, so there’s really no information on whether Qvance’s accounting includes only personnel costs or comprehensive laboratory infrastructure with its associated expenses.
The Fujifilm collaboration is a wildcard that could involve revenue
When it was announced, the CEO specifically described the partnership as “revenue generating,” referring to genuine business activity.
Hard to estimate the share price after the readout, optimistically 5+ SEK?
Of course, valuation is difficult to discuss when there are numerous potential drivers even before the readout (Q4 results and revenue data, Hong Kong developments, GMP license…). Naturally, the fact that the readout result being a “go-ahead” on its own can mean anything between decent and mind-blowing.
But I would say that’s an underestimate. That would only result in a market cap of about 60M. The share was around those levels throughout 2021, even though it was known then that the “Young” study would have to wait until 2026. Perhaps some were still waiting for a conditional marketing authorization or rapid partnering, but the announcement on August 4, 2020, **“**NextCell obtains agreement on Paediatric Investigation Plan (PIP) from EMA” probably sealed the fact that a pediatric study is required in Europe.
That 2021 valuation could certainly be described as overblown, but the company is on a completely different footing today.
-The patent protection for T1D treatment is international and multi-layered, and there are also patents for other diseases, which increases the value of partnering.
-Entirely new business has been rapidly developed under the company, for which there seems to be strong demand, and which has the potential to cover the entire group’s expenses, at least during Phase 2 in 2026.
-A potential shortcut to the Asian markets ahead of schedule has emerged for the company. Even a slightly less favorable agreement could be made there, which would nonetheless eliminate the company’s financial worries for years to come.
-Unlike in 2021, conditional approval in Europe might now actually be on the table if the “Young” results are promising. In the CEO’s interview at the end of January: “it is possible that we could even get conditional approval in Europe with that [ProTrans-Young study], and then we would want to go to the US with a ‘bridging’ study instead of doing Phase 3.”
It should be noted here that although the research pipeline currently focuses on T1D treatment, NextCell’s product is not just a drug; rather, it has succeeded in developing patented methods for stem-cell-based treatments, which could have very broad possibilities if it secures resources for development. If the T1D treatment proves successful, it should be viewed as a much broader company.
Making an actual numerical fair value estimate is almost impossible at this stage because there are so many questions in the air. However, I believe that especially if the quarterly report at the end of the month manages to show a significantly decreased group cash burn, it will remove the fear of immediate dilution, and the company should already be at a market cap of at least €30-50M even before the “Young” results. Even then, it would look cheap relative to many other R&D shell companies at the end of Phase 2. I, however, perhaps believe more in the potential of the treatment and give less weight to previous “Young” interim results than the market does, and I already considered the market reaction completely overblown even before the CEO’s comments about the honeymoon.
By the way, the stock has outrageously low liquidity. The price might fluctuate 5-8% without much “real” trading showing in the volume, just mini-volumes of 50-2000 shares, which I assume are algorithmic trades by market makers. Overall, during February, it has come down on only about €260k of turnover from the 1.7 SEK peak to today’s lows of 1.33 SEK.
Nextcell’s cell therapy support businesses, Cellaviva and Qvance, are interesting during Nextcell’s current “valley phase” in terms of the liquidity that is crucial for the company. Cell therapies in general are evolving rapidly, and as an investor not intimately familiar with the field, one might think that support functions would be a growth area. Regarding Qvance’s future, I recall the group CEO mentioning that forecast I noted about Qvance’s profitability sometime late last year, albeit in passing. Qvance’s own CEO likely has better information.
As mentioned earlier, when Nextcell’s valuation was at its lowest, €6-7m, a couple of months ago, it could be justified by this business alone. Its growth prospects provide peace of mind regarding the risk of total loss of investment typical for biotechs. Now the valuation has doubled, and with some luck, rising revenue can justify that too. Have investors not sufficiently factored in the potential of these subsidiaries?
The other matter is the main event itself, Protrans. The interim readout in late summer is a make-or-break situation. If it fails, the downward spiral could be unstoppable. Based on the evidence so far, I consider the probability of success to be good. You brought up some interesting future plans for Nextcell. Speculation will have a more solid foundation in late summer after the interim readout.
Now the valuation has doubled, and rising revenue can, with some luck, justify it as well. Haven’t investors sufficiently accounted for the potential of these subsidiaries’ operations?
I don’t believe they’ve been given much weight, as not a single euro has been seen yet. The company’s small investor base is likely suffering from a major hangover after the previous -80% crash. The base case is probably still that the company’s value is primarily just a gamble on the success of the drug pipeline and partnerships, and a company that has been diluted for six years straight will likely be diluted for a seventh. Cellaviva has been a passive shell company owning cell banks, collecting the same fixed fees year after year without any growth, and that’s why Qvance isn’t being given much credit either.
I should also include a quote from myself from the Diamyd thread:
In biotech, valuation doesn’t seem to be explained by rational probability calculations, but by certain kinds of hype cycles that fluctuate between the euphoria of early and intermediate stages and the nuclear winters caused by the despair of dilutions and long waiting periods.
Some calculating opportunists only jump into the gamble just before the results are released (like last year when the value tripled in a couple of months before the young-interim results). In small-cap biotech companies with low cash reserves, the price of the gamble while waiting for major drivers is directly proportional to the holding time and inversely proportional to the market cap, which is already incredibly small; the share count will inevitably increase significantly unless a “miracle” happens. The last offering was a disaster, and the company is also very little-known, and the researcher-led team hasn’t handled investor relations or the promotion of offerings well.
Now, the pricing seems to assume that Nextcell will have to start share issuance procedures during the current year. Perhaps even before the readout. And with the market cap jumping between 7-15M, it would mean that the share price could soon be half of the current one before the most important driver is possible.
However, the math of the expenses is in Nextcell’s favor. The costs are really low (someone could check how much Faron burns in Phase 2). So, even though losses are incurred, the specialized service operations—for which there is apparently no competition in the Nordics—might well turn the tide. Existing research staff and laboratory infrastructure can be used operationally and capital efficiently.
Personally, I believe in this miracle—with the clarification that the whole company is unlikely to turn profitable immediately before the customer base opened up by the GMP license. However, the cash might easily be made to last past the readout without dilution. Those readouts are, along with partnerships, the ultimate big catalysts in this gamble.
After the Phase 2 results, there are many uncertainties ahead, but the company has shown a smart business strategy and early limited market access is possible. There may be a wait ahead, but if the gamble doesn’t result in a loss while holding, then the expected value is positive.
And yes, it could also be that this is indeed the company’s last resort, at least as an investment. If the new young-readout doesn’t improve at all from the previous “honeymoon” results, will there still be a willing financier for the adult Phase 3 or a buyer for the licenses? At the same time, Diamyd might reach Western markets first, and the Hong Kong route might turn out to be the only way to capture revenue before market saturation. Qvance might also be just a final desperate attempt to consolidate at least some value for the company and provide work for the researchers in case the phase readout fails.
Well, whatever the case, I’m buying this gamble at least until the readout.
New press release and the stock is showing new momentum, up 12% today. For the sharp-eyed, however, this isn’t new information, because even though Nextcell hasn’t communicated this directly to investors, yours truly spotted this 29 days ago in this discussion.
The company is truly an extreme example of poor liquidity for a listed company.
Last Friday at the open:
10:03 share 1.68 (+7%)
10:05 share 1.51 (-4%)
Today the range was even wider. At the open, it rose +9.5%, and a couple of minutes later, it dipped to -5.5%. Hardly any trades were made; rather, this was most likely just the momentary spread of the share.
Interested by this, I tried to figure out how large the actual float of the share is, assuming we count all “sticky money” (tahmainen raha)—meaning, in addition to insiders, long-term anchor investors, larger institutions, partners, etc.
Instead of calculating it myself, I fed Gemini the insider transactions, key press releases, and the latest samples of the top 10 shareholders and debated for a while, correcting errors. Getting an exact figure is difficult because part of this rigid ownership is in nominee registers, and insider ownership is also held through separate holding/investment companies.
Overall, it could be said that at least a good third (over 36%) of the company is somewhat “cemented,” meaning likely not active on the market (even though there are no legal barriers to selling). Optimistically, sticky money could amount to as much as 60 million shares, or about half, if we make a rough order-of-magnitude estimate of long-term investors from previous offerings.
Whatever the “effective free float” is, it can generally be assumed to have decreased following the '25 subscription and the '26 direct investment, explaining the increased volatility to some extent.
Additionally, a significant portion of retail investors’ NextCell positions are surely at the bottom of portfolios, 70%–90% in the red, and there is no interest in realizing those losses. The company’s record 1-month volume, which has only been broken in terms of share count by the recent Hong Kong news and the 2025 Pro-Young results announcement + rights issue, was set in September 2020 at a price over 10 times higher than the current one. In terms of euro value, those recent volumes fall far behind.
The report is still messy and incomplete. CEO comments are conspicuous by their absence, etc. This started in the previous quarterly report after the CFO left. Apparently, the new CFO has not fixed the issue.
The report covers an exceptional 16-month financial year (September 2024 → December 2025) due to a change in the fiscal year, which makes direct comparison to previous years difficult. The company has admitted to this confusion and announced it will publish a separate comparison document to clarify the figures shortly after the report.
Revenue from QVance does not yet appear to be recognized, which is a disappointment. This is in direct contradiction with the company’s comments that turnover would have accumulated since at least late summer.
In practice, however, it seems that QVance’s sales are visible in the items Advances received and commitments (+1.1 MSEK, the parent company’s share of this growth was almost non-existent), Unbilled work and accrued income (increased by approx. 0.9 MSEK from a year ago), and Accounts receivable (increased by approx. 1M SEK at the point when QVance was said to have become operational).
Although accounts receivable and advances point to some kind of operational activity, the company’s cash position fell to 26 million kronor by the end of 2025 (32.7 MSEK the previous year). This was influenced at least by QVance’s new isolator, which appears on the balance sheet likely as a 4.4 million kronor work-in-progress acquisition.
Diamyd apparently owns about 15% of NextCell. Diamyd plummeted 90% today, and now there’s likely concern they’ll dump their NextCell shares due to a cash crunch. NextCell has dropped about 15% today. What are your thoughts on the situation? Is there also a slight worry creeping in about the viability of NextCell’s development pipeline?
Trading volume has picked up today, and about 3 million shares have already been traded in an hour. The stock is now at that one krona mark; it’s easy to guess that Diamyd has finalized its next steps and is now selling off its holdings. According to AI, they had about 5 million shares.
So today, it dropped 15% right at the start of trading to that one krona level, and there is no news for today.
I bought some now, assuming that the threat of Diamyd’s selling pressure is dissipating, and I believe they have also figured out in advance at what price the position could be offloaded—i.e., at what price a large buyer/buyers can be found.
Today, NextCell released information regarding a collaboration with Fujifilm Biosciences. They are launching their first joint commercial product for research use. Fujifilm, a multi-billion dollar company, is a global leader in the development of cell culture materials. NextCell’s patented expertise using an MSC (Mesenchymal Stem Cell) selection algorithm—which produced the Phase 2 candidate ProTrans—is likely part of this collaboration. The commercial product is NextCell-Cord RUO, which consists of selected MSCs in cell culture media as various products. These are intended for research use only (RUO). Fujifilm will handle the global marketing.
In the short term, over a one-year horizon, the financial impact of this activity on NextCell’s results is estimated to be limited. The point, however, is that cell research and therapy volume is a growing field. I recently saw an estimate that the annual revenue growth for service operations in this sector could be around 30% per year.
As previously noted in this thread, NextCell’s cell business at these current market valuations leaves something for the shareholders, even if ProTrans were to “do a Diamyd” (fail in late-stage trials).
