Diamyd Medical - World's first diabetes vaccine

[Taavetti]

@Pohjolan_Eka

On a general level, the spread of anti-vaccine sentiment in our society is the responsibility of morally rotten evil people among us. This is clearly the best invention in human history, the only way we can ensure a healthy life for the vast majority of the population, protected from deadly and debilitating diseases until old age. Just 100 years ago, it was quite common to die young from tuberculosis, whereas in the 21st century, the death of a young person from an epidemic would be completely unheard of. Unfortunately, nowadays on social media, one only hears the voice of vaccine-hostile people, as the state has neglected to disseminate pro-vaccine information. If the Devil of the Bible existed, his primary goal would be to make people fear taking vaccines.

Taavetti agrees, but still wants to slightly oppose @Pohjolan_Eka.

Are you examining this moral question from the perspective of the individual, humanity, or the biosphere of our planet? If one has to conclude that there are too many people for the planet’s carrying capacity, one can easily arrive at quite abrupt interpretations of what is good and what is evil. However, Taavetti managed to interpret the chaotic alternatives that might lead to even larger reductions in human populations over a suitable timeframe as evil. It would be better if the activity were not chaotic, as chaos would most likely lead existing social orders to maintain this alarming growth of the human population.

In Taavetti’s opinion, economists’ models are broken in this sense, and societies measure and compare the wrong things when examining how well each country is doing. However, Taavetti has no answers as to what should replace them, and otherwise, the aforementioned claim is written more with emotion than with knowledge.

These comments are very distantly related to Diamyd Medical. May be deleted.

[Mauski]

Nextcell’s offering ended yesterday, but the results will only come on Monday. However, the stabilizing effect of the subscription seems to have ended, and the stock is up 13%.

By the closing, there has been no announcement that Diamyd would have subscribed for its share. Would it have been frowned upon to subscribe to another company when they just raised their own funds, even if there’s now some extra cash?

[Gubrick]

@Mauski

So, additional subscription amounted to approximately 5.5 million SEK. According to Nextcell’s latest report, Diamyd’s ownership stake in Nextcell seems to have decreased to 6.8 percent.

• The warrants are based on the summer 2024 issue. One share entitled to 11 subscription rights, and ten rights entitled to one subscription right (share + warrant)
• If Diamyd had maintained its subscription rights relative to its share ownership and subscribed to all its subscription rights, it would amount to 5.46M SEK

Is it a coincidence?

When I delved deeper into the numbers, it appears that Diamyd has actually increased the number of Nextcell shares it owns in every report. Although ownership decreased from 12.5 → 7.2 → 6.8% over the last year, the number of shares has still increased from 4M → 5M. As far as I understand, Diamyd has previously subscribed to all its owned rights, but apparently divested some shares as the price rose significantly and its own cash reserves dried up during 2024.

Diamyd subscribed to a total of 943,396 shares in Nextcell’s 2024 issue, exactly one million SEK worth. This is visible in the Q4 report:

A total of 46,627,471 subscription rights were available, and thus 9,433,960 were used, meaning 37,193,511 subscription rights remained. At the same time, 639,000 SEK in income was recorded, so it appears that the excess subscription rights were sold at an average price of 0.01718 SEK.

@Mauski

By the deadline, no announcement had been made that Diamyd had subscribed to its share. Could it have been viewed negatively that they had just raised their own funds and then subscribed to another company, even if there was some loose cash now?

The matter is probably not announced because 943,396 warrants is such a small stake that it cannot be announced. But I do believe all those warrants will be exercised; it’s still less than a million SEK.

However, even if Nextcell reached a 100% subscription rate for the warrants, the situation would remain difficult, and longer-term financing would be needed again by the end of the year. Diamyd is among the top 3 largest owners, so it should also participate in the financing. The image shows the cash situation with a 70% subscription rate.

[Mauski]

The cash situation will likely be helped by the fact that the 100% owned new subsidiary, QVance, is expected to generate revenue already in H2 2025. QVance apparently had demand from BP customers right from the start, which is why it was founded. Cellaviva’s sales also grew by 39% in the last announcement. There is also a project starting with Fujifilm Irvine Scientific, but it remains unclear if it will generate revenue.

The rhetoric suggests that Nextcell’s goal is to make licensing agreements soon, during phase 2. The press release title also bodes well (and on the other hand, it might be a trick to promote the subscription): “ahead of licencing discussions”

In my opinion, the Novartis executive joining as an advisor is extremely promising. The announcement did not clarify whether he represents Novartis directly or himself, but can one even do such a thing on their own behalf when working specifically as a portfolio management director at a multi-hundred-billion BP company?

[Mauski]

Nextcell’s offering outcome was announced – 64.4% of warrants were exercised, and with guarantees, 36.6M SEK will be raised, with a target of 40M SEK. Surprisingly little through warrants, considering the news. However, I’m not really disappointed, as the market situation is challenging. This should be enough to cover the licensing discussions, if they are indeed starting now.

There was indeed a huge difference in the marketing of Nextcell’s and Diamyd’s offerings. Diamyd appeared numerous times in streams and investor events during and before the subscription period. Nextcell didn’t bother much with advertising.

No significant market reaction yet. ±0% and negligible volume.

NextCell Pharma announces outcome of use of TO2 and resolves on directed share issues to guarantors

[Mauski]

More on Nextcell: A couple of weeks ago, Nextcell announced a partnership with Fujifilm Irvine Scientific. On the surface, this bodes well, even though it seems to relate to something other than Protrans. It appears that the collaboration will produce standardized products for stem cell therapies, which is a new business area, and potentially aims to promote the validation/quality control service established through QVance. It’s great news that the company is simultaneously developing other business. ATMP quality control alone is a rapidly growing multi-billion market, and it’s possible that in a few years, QVance’s business alone could justify the current market value. Now, this on top of that. So, not everything is dependent on Protrans anymore, and the company seems willing to package other businesses into the same group, meaning it’s not entirely a “make it or break it” situation.

2025-05-20 NextCell Pharma AB (“NextCell” or the “Company”) has entered into a strategic collaboration with Fujifilm Irvine Scientific Inc. to combine their core competencies in mesenchymal stromal cells (MSC) and raw materials for life science. The goal of the collaboration is a comprehensive offering to researchers, biotech and pharmaceutical companies in the field of cell therapy – standardized MSC products, optimized cell culture and cryopreservation solutions.

However, I noticed that Fujifilm has shifted into a completely new gear regarding cell therapies. Fujifilm has recently revamped its strategy and rebranded its key companies into clearer players. According to a press release published today, FUJIFILM Irvine Scientific is now FUJIFILM Biosciences (focusing on cell culture solutions and reagents) and FUJIFILM Diosynth Biotechnologies will henceforth be known as FUJIFILM Biotechnologies (handling CDMO services, i.e., contract development and manufacturing). At the same time, the Fujifilm Medical Media business unit, which focused on IVF treatments and chromosome research, was divested elsewhere. The overarching name for the entire operation is “Fujifilm Life Sciences” and the slogan is “From Discovery Through to Commercialization,” meaning they aim to offer end-to-end solutions for drug development, from research to commercialization. Previously, Fujifilm has invested over 10 billion dollars in this field over the past 15 years. The entire Fujifilm Holdings group is quite a giant anyway, with a turnover of €20 billion and aiming for a turnover of approximately 4 trillion yen (approx. 29 billion USD) by 2030.

Although this current collaboration does not directly concern the clinical manufacturing of ProTrans, there is clear potential here! As ProTrans progresses towards later stages and commercialization, Fujifilm Biotechnologies could be a very strong candidate as a contract manufacturer for ProTrans. Fujifilm’s massive investments and clear focus on “end-to-end” solutions in life sciences mean they have both the muscle and the interest to be involved in promising development projects. In the longer term, if ProTrans proves successful, I wouldn’t rule out deeper interest from Fujifilm, as they have the resources and strategic desire to grow in this sector. Much, of course, depends on ProTrans’s future results, but an interesting setup nonetheless!

In practice, Nextcell has now engaged with three big pharma companies in a short period!

• bioMérieux (18.12.2024 partnership with QVance)
• Fujifilm Life Sciences (20.05.2025)
• Novartis (28.05.2025 portfolio manager as advisor)

What do people here think, should a separate thread be created for Nextcell if I provide comprehensive analyses and introductions in the opening post? With a 7% ownership stake, this can’t really be called a subsidiary of Diamyd, and both companies will likely have a lot of their own news flow throughout the summer and rest of the year. Now the discussion is getting a bit mixed up, and the opening post doesn’t address the Nextcell topic.

This is a rather small and unknown company, but I find it extremely interesting at the moment. It is currently the second largest risk investment in my portfolio. The sample sizes are quite small, but based on studies, it has good prospects for securing funding for Phase III, and the company’s clear goal is to secure a licensing agreement before that. Phase III funding alone would bring tens of millions to the balance sheet – while the company’s market value is a mere €10M after dilution.

[Clark_kent]

@Mauski

What do people here think, should a separate thread be made for Nextcell if I make comprehensive analyses and presentations for the opening post?

Your presentation in this thread was indeed so high-quality that I would gladly read similar content. It feels like biotech is now offering opportunities here and there (although I am mainly a long-biased optimist interested in biosciences)

[Gubrick]

@Mauski

The cash situation will be helped by the fact that the 100% owned new subsidiary QVance is expected to generate revenue already in H2 2025. There was apparently demand for Qvance from BP customers right from the start, which is why it was founded. Cellaviva’s sales also grew by 39% in the last disclosure. There is also a project starting with Fujifilm Irvine Scientific, but whether it will generate income remains unclear.

How critical are QVance and Cellaviva for the ProTrans study?

Cellaviva would at least fare well independently and would already be more valuable on its own than the entire company’s market capitalization.

@Mauski

The rhetoric suggests that Nextcell’s goal is to make licensing agreements soon, during phase 2. The press release headline also promises good things (and on the other hand, it might be a trick to promote the subscription): “ahead of licensing discussions”

In my opinion, the joining of the Novartis bigwig as an advisor is extremely promising. The announcement did not state whether he represents Novartis directly or himself, but can one even do such a thing on their own behalf when acting specifically as the head of portfolio management in a multi-hundred-billion BP company?

I don’t believe that with these results, there would yet be prerequisites for a deal to materialize. The market doesn’t even consider it remotely possible, otherwise the stock price would be many times higher.

@Mauski

Nextcell’s offering result came in - 64.4% of the warrants were exercised, and with guarantees, 36.6M SEK will be raised, with the target being 40M SEK. Surprisingly little through warrants, considering the news. However, I am not actually disappointed, as the market situation is challenging. This should be enough to get through the licensing discussions, if they are indeed starting now.

The result was poor, there’s no denying that, especially considering that guarantors had to be secured.

@Mauski

There was indeed a huge difference in the marketing of Nextcell’s and Diamyd’s offerings. Diamyd appeared numerous times in streams and investor events during and before the subscription. Nextcell didn’t bother to advertise much.

With Diamyd, it was a rights issue, and here it was only about subscribing to warrants. It was thought to be a straightforward process, as the average price method was used. In hindsight, the lower limit could have been set even lower.

So, in summary of Nextcell’s situation: no one believes that external money will be coming in, but the market is pricing in a large offering for this year. It would certainly be larger than in 2024, but at these prices, it cannot be pursued. Before that, more results are needed, and fortunately, there is now time to wait for them with the money received from the warrants.

@Mauski

What do people here think, should a separate thread be created for Nextcell if I make comprehensive analyses and presentations for the start? With a 7% ownership stake, this cannot really be called a Diamyd subsidiary, and both companies will probably have quite a lot of their own news flow during the summer and rest of the year. Now the discussion is getting a bit mixed up and the opening post doesn’t match the Nextcell topic.

Presentations are interesting!

However, the readership in both threads would probably be countable on the fingers of one hand and consist of the same group of people.

[Mauski]

Carnegie has reiterated its valuation of 14-23 SEK. Assumptions include WACC 13-20%, 65% probability of success, a €400M partner deal, and 40% royalties from €900M peak sales. The valuation still includes the ongoing Phase III treatment.

A quarterly report was also received at the end of last month. The report mentions, among other things, a regulatory inspection of the production facilities during 2025, which is required for submitting the BLA application.

Ulf’s new interview was also recently published.
-The CEO mentions, among other things, that all BPs are currently aware of Diamyd and its upcoming research results. According to the CEO, the BreakthroughTD1 organization, which supports Diamyd, stated that at a recently held conference, “all BPs” were asking it about Diamyd.
-Ulf also mentions that if all goes well, GMP certification could be obtained as early as this year.
-Phase III already has 250 patients enrolled, and the dropout rate is still below 1%. Recruitment is on schedule, and the goal will be reached this year.

https://youtu.be/VQDj-m9dCzE?si=QZAv03mUDxpol84H&cc_lang_pref=fi&cc_load_policy=1

[Gubrick]

@Mauski

Carnegie has reiterated its valuation of 14-23 SEK. Assumptions include WACC 13-20%, 65% probability of success, a €400M partner deal, and 40% royalties from €900M peak sales. The valuation still includes the ongoing Phase III treatment.

A quarterly report was also received at the end of last month. The report mentions, among other things, a regulatory inspection of the production facilities during 2025, which is required for submitting the BLA application.

Ulf’s new interview was also recently published.
-The CEO mentions, among other things, that all BPs (Big Pharma) are currently aware of Diamyd and its upcoming research results. According to the CEO, the Breakthrough T1D organization, which has supported Diamyd, stated that at a recent conference, “all BPs” were asking about Diamyd.
-Ulf also mentions that if all goes well, GMP certification could be obtained this year.
-Phase III already has 250 patients enrolled, and the dropout rate is still below 1%. Recruitment is on schedule and will be completed this year.

Waiting is still boring at this stage.

Recruitment is progressing quickly, as there were 220 patients at the end of April. So, despite the quiet early summer, the patient flow has continued, certainly thanks to the Breakthrough T1D organization.

The proportion of HLA DR3-DQ2 positive individuals was also discussed. It has so far been observed to be as high as 52%. If it really is even 50%, the number in forecasts could be raised from 35%-40% to even 43%, which would have almost the same impact on the bottom line and thus on the value, around 27%. That is, if the estimates for penetration, etc., could be kept the same. More precise information is certainly desired before contracts can be written.

Carnegie’s analysis is total crap. The written part is still quite readable, but the target price determination uses a share price + 50% technique. Just a year ago, the EV was precisely calculated to be 3768MSEK, but now it is naturally not even half of that.

With those parameters, it is impossible to reach a share value of 14SEK without modeling in the costs of another Phase III study or something else unusual. I would bet that if the price rises now before the results, the parameters will change on the fly, even if nothing has actually changed.

Are you more precisely aware of the Breakthrough T1D deal? What kind of royalties need to be paid there, when, and how much? Roughly max 2x the support received?

[Mauski]

Carnegie’s analysis is total garbage… I could bet that if the stock price rises now before the results, the parameters will change on the fly, even if nothing has actually changed.

Still agree. But isn’t that how it practically goes with almost all other companies .

Are you otherwise more specifically aware of the Breakthrough T1D deal? What kind of royalties need to be paid there, when, and how much?

No exact details have been given about this. Mentions are only at the level of “limited royalties”. An indication might be that the grants given by BTD1 as a commitment to these royalties are marked in the balance sheet as long-term liabilities. So, at least one could assume that at a minimum, the royalties will pay back the grant. It would hardly be possible to put anything larger than this into accounting yet. BTD1 has apparently done quite a lot of enthusiastic lobbying and other work on behalf of Diamyd, so I believe they will be rewarded quite well if the venture succeeds.

[Mauski]

Ulf also confirmed earlier in the video the assumption that the medicinal protein is manufactured at Diamyd’s factory (red) and transported directly to the neighboring APL factory where it is infused and packaged. This also supports the hypothesis that APL’s investment, which included increasing the capacity of the sterile packaging production line by 50%, especially for injection vials, is essentially related to Diamyd. The line should be ready in 2026. According to the latest APL publication, it is on schedule, but more specific information about the timing has not yet been provided.

If APL’s current production capacity could be found somewhere, order-of-magnitude calculations could be made for maximum production volumes with this setup. Of course, packaging services can also be obtained elsewhere if needed.

[Mauski]

The stock is now in a quite good technical position. As mentioned above, I expect a significant positive price increase that will accelerate towards the spring 2026 report. Now there would be good conditions for it to start, as long as the 10 SEK resistance is overcome. Diamyd’s stock has a history of building long, strong momentum uptrends that are only broken by offerings. Now there are extremely good conditions for such a trend to start.

-The price has moved above the 21-week and 9-week moving averages this week
-Today, the daily MACD (9:21) positive crossover
-The weekly MACD has been on a positive signal since the beginning of June. The monthly MACD is on a weakening bearish signal, and the MACD line’s derivative might turn positive this month
-200 4h, 50 4h, 21 4h, 50D, 21D, 9D and 9W MAs have turned positive
-A positive 9:21W MA cross appears to be happening next week, unless the price drops significantly before then. A positive 50:200W MA cross is also very close and might materialize in the coming weeks if we get above 10 SEK.
-Long-term RSIs are at a very moderate level and all have a positive slope.

The 50/200W MA crossover is so rare, by the way, that it last occurred in 2018 and was followed by rallies from 5 SEK → 70 SEK. The rallies were, of course, driven by news, but positive technical signals support a more permanent trend.

[Mauski]

I made a new thread for Nextcell because the introduction became quite long from the start. Things could have been packaged under the same TD1 thread if this had been noted in the original post, but in this discussion too, the focus has been on company-specific matters, not the industry in general.

Nextcell is, of course, quite a minuscule small company to deserve its own thread, so the readership will surely remain small. I prefer a little quality, rarely, over miscellaneous fluff.

Nextcell’s stem cell therapy is also considerably more generic compared to Diamyd, with a wide range of potential treatments, even though the initial focus is on TD1 treatment. I could later start delving into the mechanisms of action and the market for MSC treatments more generally.

https://keskustelut.inderes.fi/t/nextcell-kantasoluilla-kohti-mullistusta/64958/2

[Clark_kent]

@Mauski

Result
Based on these factors, I estimate, as a rough estimate, that the probability of Diamyd receiving accelerated marketing authorization based on the 15-month C-peptide results of the DIAGNODE-3 study in March 2026 is moderately high, 55-65%. However, the overall probability of success once the 24-month results are published is significantly higher, 75-85%.

I tried to examine the probability of success for the Phase 3 interim readout (15 months) concerning the second primary endpoint, the difference in C-peptide preservation between the treatment and placebo groups (Mean C-peptide AUC treatment difference), based on Phase 2b, the Clinicaltrials description, and This protocol description, using Bayesian inference with the help of AI. This is a good comparison because Phase 3 is conducted with the same treatment protocol as Phase 2, and the inclusion criteria and treatment response criteria are the same.

Assumptions: phase 2 sample size: Active DR3-DQ2 n=29, Placebo DR3-DQ2 n=19
Treatment effect 1.557, CI 1.126-2.153
Phase 3 sample size 330, 2:1 active:placebo
Target alpha 0.04 - two sided
Success criterion treatment effect 1.4 (Teplizumab Phase 3 was 1.59)

The result was 69.9%. I’ve only completed a basic course in statistics, so I cannot verify the correctness of the calculation. But practically the same result as your estimated 55-65%, if we consider that accelerated marketing authorization would be granted with a 90% probability with that result!

[Gubrick]

I did a slightly more fundamental analysis of what the market is currently pricing in: Diamyd Medical — Pricing the Binary Bet Ahead of the Phase III Interim Readout

Using a binary Martingale model, the result is that the readout succeeds with a 34% probability, in which case the share price is 34.25. A share price of 11.50 has been used, and a warrant price of 2.00. The warrant may have priced in a slight advantage, which lowers the probability of success but increases the share price upon success.

A price of 34.25 corresponds to a valuation of SEK 5.3 billion after the readout. This is in a situation where marketing authorization will be obtained within approximately one year with >90% probability, over SEK 400 million in cash, and a licensing agreement can be concluded by auction.

It’s difficult to see market expectations falling further from this point before the interim readout — but there is still room for upside. If one is willing to bet that the probability rises to even 60% before the readout, then significant returns are already available before the readout. At best, the share value in a successful scenario could also be increased, which would also be reflected with leverage in the warrant’s value.

[Clark_kent]

Hats off. I wish I knew finance theory as well. I hadn’t noticed that the interim reading is from 170 patients. That slightly increases uncertainty at this stage. I think the practical S-negative is higher, because there is a significant mass of possible outcomes from the 15-month reading where one remains in the grey area, where some probability for the success of the 24-month reading still needs to be priced in.

[Gubrick]

@Clark_kent

Hats off. I wish I knew finance theory as well. I hadn’t noticed that the interim readout is from 170 patients. That slightly increases uncertainty at this stage. I think the practical Snegative is higher because there is a significant mass of possible outcomes for the 15-month readout where we remain in a gray area, where we still have to price in some probability of success for the 24-month readout.

Thank you. At the time of the latest update, 250/330 patients had been recruited, and the goal is to collect the rest by the end of the year. So, the final readout is estimated to be completed in December 2027. If the evidence from the interim readout is not sufficient, sales forecasts would have to be pushed back by two years. And the warrants would likely yield nothing, so about 200 million Swedish Kronor would have to be raised from somewhere, probably at a poor valuation, to get to the readout.

In addition, one can think of it Bayes-style: if 170 patients are not enough for a clinically and statistically significant difference at 15 months, then what is the probability that 330 would be enough at 24 months? Certainly not a very high probability, and then the efficacy would certainly not be as good as dreamed of now.

Phase IIb was also practically identical in its setup compared to the ongoing Phase III study. As a result, C-peptide was preserved 55.7% better compared to placebo. 95% confidence interval 12.6% - 115%. And a p-value of 0.78%. These results were achieved with n=46, of which 29 received the drug and 17 received placebo. Now, out of 170, 114 receive the drug, which is almost four times the amount.

The study is also designed to produce favorable results at this point, and everything is banking on that. So all gray outcomes belong to the negative scenario.

[Clark_kent]

@Gubrick

So all grey outcomes fall into the negative scenario

I hadn’t realized the significance of warrants here. So even if we were, for example, just barely on the threshold of significance… then accelerated marketing authorization would not come, and sales forecasts would shift forward, and warrants would become worthless, and a negative spiral would again be possible.

But what about a super scenario? That is, a significant result in C-peptide and long-term hemoglobin (HbA1C)? In Phase 2b, we were close (p=0.121@15 months), and this is now genuinely within the realm of possibility. The market doesn’t expect it, nor is it needed for marketing authorization. But it would be a very robust indication of the drug’s efficacy. Even the best insulin treatment cannot replace one’s own hormonally regulated production.

[Gubrick]

@Clark_kent

But what about a super scenario? That is, a significant result in C-peptide and long-term hemoglobin (HbA1C)? In Phase 2b, we were close (p=0.121@15 months), and this is now truly within the realm of possibility. The market does not expect it, nor is it needed for marketing authorization. But it would be a very robust indication of the drug’s efficacy. Even the best insulin therapy cannot replace one’s own hormonally regulated production.

So, do you mean more from the perspective that a significant HbA1C result would reduce doubts about whether there is a linear relationship between it and C-peptide, or are you more concerned about the sufficiency of a (good) C-peptide result as a surrogate for marketing authorization?