For me, Prolight is a no-no because it’s one of the companies of board chairman Masoud Khayyam. Previously as CEO at Spectracure, for years no progress, just big promises. PR releases. Share issues. Some phase 2 was supposed to start already in 2019 but nothing was ready.. The product is also a completely incomprehensible contraption…
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How could commercialization already begin in H1 after validation? It would only be completed in H1 2026, after which it would take approximately another year to obtain permits?
No miracles are expected from Spectracure either, with a market value of less than 10MEUR at the subscription price, of which over half is cash. No one follows the stock, and the paper changes hands at 5x the subscription price, even though there would be enough shares for everyone if the share capital is tenfold, even if warrants are taken into account.
Have you followed the company more closely? Apparently, some studies would be completed this year. If, after the results, the value of the projects can be estimated at even a few million euros, then funding would again be secured with warrants for a long time.
This guy doesn’t seem to have much involvement in the actual operations of the company. He hasn’t really been visible even presenting the company or managing investor relations publicly; the CEO has always largely handled things.
Additionally, as good news: Masoud has declined the chairman (PJ) candidacy in the upcoming general meeting.
How could commercialization already begin in H1 after validation? It would only be completed in H1 2026, after which it would take approximately another year to obtain permits?
Yes, I’ve also been thinking about the realism of the schedule. Superficially, reflecting on the typical durations of studies and evaluations, this should be almost impossible. Or it’s strategic communication from the company with offerings looming, and H1 2026 only refers to submitting the application.
Taking an optimistic view: Those indicative durations for the permit process may not be accurate, and Prolight has been preparing the application for a long time. I believe that many bureaucratic stages are already underway or will begin at the end of pre-validation, but the duration of the validation study concerns me the most. It’s quite a squeeze to get a sufficient number of users in that time.
In similar POC validations, the sample size has been 500-1500 patients. However, it feels like in practice, these large validations have been half pre-marketing. Large companies sometimes call validation an “early adopter program” in marketing terms, and market entry is a somewhat looser process. IVDR does not set a clear number for the sample size, but in practice, 95% confidence intervals should be achieved, and a significantly smaller sample should suffice for that. It could be that Prolight also goes this route. During the study, devices must be marked “for research use only” and can be charged at zero margin, but through this, production and visibility can be accelerated before CE marking. Hopefully, a marketing partner would already be involved at that stage.
Prolight has had the ISO-13485 standard since November 2023. This phase alone could take 6-18 months. In addition, it is already with a contract manufacturer. Mdx CRO was appointed as a validation partner over a year ago. Although its named function so far is the implementation of the validation study, its core business also includes regulatory application processes and technical documentation. If Prolight has done things smartly, it has also been preparing the application for a long time with its partner, and hopefully, the clinics participating in the study have already been agreed upon.
Accelerating the final application may also be a major reason why a separate pre-validation was carried out and why it was conducted as such a comprehensive third-party study. If no essential changes need to be made to the device, it may be possible to finalize most of the application documentation based on the pre-validation, and these can be sent to the body evaluating the application (“notified body”) in advance. This is not sufficient for the final IVDR permit, as performance evidence must be collected in a decentralized manner across multiple clinics, and this is only done at St Thomas’ Hospital. In a good scenario, once validation is complete, everything else is already documented and audited, and what remains of the application process is the qualitative and quantitative evaluation of the final validation. Once the overall evaluation is completed, the permit will only take 1-2 months.
However, to my knowledge, Prolight has not pre-appointed a body (“notified body”) to evaluate the application. For market entry by summer 2026, the evaluation should already have been agreed upon. However, this information is not always published anyway, perhaps due to contract clauses or because these bodies are not wanted to be seen as “partners.” Based on a little Googling, many companies announce this only when they report having submitted, for example, technical documentation for evaluation or only when the CE mark has been granted.
Overall, however, there’s quite a lot of speculation, and ultimately it must be stated that Prolight has communicated an extremely ambitious schedule, but it has not provided very good reasons for its achievability. This could be a good point for questions at the general meeting.
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Apologies for the spam in the Prolight thread. Prostate cancer is difficult because it’s so common, making competition fierce. One would need to be a urologist to stay on top of the scene. I even doubted Orion’s medicine – I was wrong.
But new treatment methods are needed locally because complete prostatectomy is excessive treatment for many and causes side effects. External radiation therapy is another option and has different side effects.
This Spectracure device falls into the category of focal ablative therapies. As I understand it, verteporfin is administered intravenously, and a fiber optic cable is inserted into the prostate, through which the drug is activated. For local ablative therapies, there has been a HIFU ultrasound-based method since 2015. HIFU went through the de novo approval pathway. Then there’s focal laser, cryo, radiofrequency ablation, and a couple of others. These competitors went through the 510k pathway. So, all are medical devices, and their use in cancer treatment is off-label.
An exception is Tookad, a drug similar to verteporfin for use with PDT, which did not receive FDA approval, but it tried the drug approval pathway. EMA, however, approved it. So, in Europe, focal PDT is already approved, which is exactly equivalent to Spectracure’s treatment.
Spectracure certainly wouldn’t have the muscle for drug approval studies but rather 510k. In this case, there won’t be any actual strong evidence of benefit. I don’t know what Spectracure’s niche would be when there’s so much competition.
-low valuation, but too complex for me for a long hold. Also too binary a case for my taste (Diamyd an exception 
) If the anti-cancer drug passes and biotech sentiment recovers, this will easily double… but still, new treatments are needed for this, and the market is HUGE. I’m indirectly betting on isotope therapies (Telix and Curasight)
I also read Spectracure’s prospectus. A lot of talk about phases and not a word about medical device regulation. They are first trying for recurrent local prostate cancer. This will still cost a lot of money.
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Thanks, a rocky road ahead then. Companies like this should have a wealthy main owner who would guarantee rights issues without compensation. Now, practically anyone with a bit more money gets a guarantee deal, and small investors suffer dilution. Then the guarantors dump the shares on the market, and six months later, new guarantors are sought for warrants, and the same cycle continues.
And rights issues are always implemented at the last minute, leading to expensive bridge loans. Then a new rights issue, of which 25% goes to various expenses. Now, however, it seems that the management itself doesn’t believe that even half of the issue will be subscribed, so warrants must be set to expire in just six months. If the subscription rate remains around 50%, the costs will be closer to half of the gross proceeds.
The discount to TERP and the current market price are indeed tempting, but we’ll see what happens when ten times the previous number of shares enters the market and the guarantors start selling them off.
And what’s the deal with pumping the stock 5x above the subscription price just as the subscription period begins? There are plenty of warning signs, and it doesn’t add more credibility to Prolight either that the management includes the same people. Masoud also has a habit of publishing pumping-“analyses” from noname “analysts” as press releases for both companies. One can only wonder how much the company spends its scarce money on paying for these “analyses.”
In the “base scenario,” everything goes smoothly, and the market value is naturally around 400MEUR. In the bull scenario, the company is sold for 2.5 billion soon, promising a 13,678% return, provided one participates in the rights issue.
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Tänään tuli ensimmäiset tulokset (25/120) tuoreen veren tutkimuksista. Kurssi pomppasi aluksi tarjoten hyvän myyntipaikan. Kaikkiin tutkimusuutisiin liittyviin pomppuihin kannattaa myydä niin paljon kuin likviditeettiä riittää, koska tuloksien odotetaan olevan hyviä, jolloin tutkimuksen riskien pieneneminen voi nostaa rNPV arvoa maksimissaan muutaman prosentin. Uutiset, joilla on vaikutusta arvoon, liittyy aikatauluun ja rahoitukseen.
Antiesitteestä sai sen käsityksen, että Q2 loppuun mennessä tutkimustulokset olisivat valmistuneet kokonaisuudessaan:
Nyt kuitenkin vasta osa on valmista, vaikka tutkimus aloitettiin jo aikaa sitten. Näyttää siis siltä, että hyvä jos tulokset on kasassa vuoden loppuun menessä, jolloin varsinainen myyntilupaan tähtäävä tutkimus pääsisi alkamaan vasta H1 2026.
Tässä vielä Q2 2024 raportin yhteydessä kerrotusta aikataulusta:
Eli vuodessa aikataulu on siirtynyt käytännössä vuodella eteenpäin.
Jos siis varsinainen kliininen tutkimus valmistuu 2026 lopussa tai 2027 alussa, niin kaupallistaminen voisi alkaa joskus 2028, kun ensimmäiset luvat on saatu.
Ja silloin herää kysymys, että kuinka realistista kaupallinen edistys seuraavien 12kk aikana olisi? “Early 2026” on ainakin utopiaa kaupallistamisen suhteen tässä kohtaa. Miksi jakelukumppani edes sitoutuisi sopimukseen jo tässä kohtaa, kun mitään näkyvyyttä ei ole? Siitä syystä myös kaikki etumaksut, joita Prolight kipeästi tarvitsisi, kävisivät uskomattoman kalliiksi.
Arvioni mukaan 100% merkintäasteellakin, rahat riittäisivät juuri ja juuri 2026 loppuun. Eli ennen kuin kaupallistamista ja sopimuksia aletaan edes miettimään niin edessä voi olla parikin antia.
Likviditeetti sen verran pientä, että ei kannata lyhyelläkään tähtäimellä paljoa merkata, vaikka osakkeista todennäköisesti pääseekiin eroon kalliimmalla. Annissa ei ole käytännössä mitään merkittävää isompaa ankkurisijoittajaa mukana, niin suuri osa uusista lapuista lentää laitaan aika nopeasti.Today, the first results (25/120) from the fresh blood studies were released. The stock price initially jumped, offering a good selling opportunity. It’s advisable to sell as much as liquidity allows on all jumps related to research news, because the results are expected to be good, meaning that the reduction in research risks can increase the rNPV value by a maximum of a few percent. News that impacts the value relates to the schedule and financing.
The offering memorandum gave the impression that the study results would be fully completed by the end of Q2:
Now, however, only a part is ready, even though the study started a long time ago. It therefore seems that it would be good if the results are gathered by the end of the year, in which case the actual study aiming for marketing authorization could only begin in H1 2026.
Here is the schedule as reported in connection with the Q2 2024 report:
So, in one year, the schedule has practically shifted forward by a year.
So, if the actual clinical study is completed by the end of 2026 or early 2027, commercialization could begin sometime in 2028, once the first approvals have been obtained.
And then the question arises: how realistic would commercial progress be in the next 12 months? “Early 2026” is at least a utopia regarding commercialization at this point. Why would a distribution partner even commit to an agreement at this stage when there is no visibility? For that reason, any upfront payments that Prolight desperately needs would also be incredibly expensive.
In my estimation, even with a 100% subscription rate, the funds would barely last until the end of 2026. So, before commercialization and agreements are even considered, there could be a couple of offerings.
Liquidity is so low that it’s not worth subscribing much even in the short term, although shares can probably be offloaded at a higher price. In the offering, there is practically no significant larger anchor investor involved, so a large portion of the new shares will be sold off quite quickly.
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In my estimation, even with a 100% subscription rate, the funds would barely be enough until the end of 2026
Well, that 100% subscription rate has now been achieved. The share remained sufficiently above the subscription price that the subscription was filled 30% without subscription rights.
I myself consider it very likely that a commercialization deal will be agreed upon within the next year, supported by pre-validation data. If such a deal is to be made at all. I myself am not worried about possible future offerings, which are well into 2026.
Excellent result.
H1 2026 is at least entirely time to try and seek a deal. It wouldn’t even need to cover the entire funding need, because after that, money could be brought in again with good valuation and small dilution.
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Most likely, a decision will soon be made on an additional share issue, because the offering was most likely oversubscribed. Subscriptions probably exceeded 100%, but the excess was just cut for now?
Did anyone attend the shareholders’ meeting or the investor presentation held at the end of the month? I would be very interested to know what the management said about future schedule targets.
I find the company’s communication regarding the schedules rather odd.
- Pre-validation results were supposed to come in Q4 2024, and the actual validation was supposed to start in early 2025.
- Pre-validation results were reported to come in Q1 2025.
- Pre-validation results came at the end of Q1, but they were partial and very superficial. Whole blood results were reported to be only coming in H1 2025.
- Whole blood results came on June 16th (image below), but they are also only preliminary, and results are still being collected.
- The actual validation was supposed to start in early 2025, but the company has not communicated anything about a delay or stated what has been the impediment.
The same stock exchange release implies that this is the “first phase of the study,” which leaves it unclear whether new phases are occurring before the final clinical study.
Successful completion of the first phase of this study marks another milestone as we prepare for our pivotal clinical study.
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Did it end up being exactly 100% after all? Can it be possible? With what probability?
Unfortunately, I couldn’t make it.
There is no visibility into the schedule.
It cannot be that the official offering prospectus states that results will be available by the end of June, if in reality it means that 25/120 results will come and the rest will come when ready.
In connection with the offering, it was stated that it would begin in H2 2025:
A positive outcome will be essential to advance toward a strategic partnership and enable completion of the full regulatory clinical performance study, which is expected to begin in the second half of 2025.
I have understood that the previous study must be completed before the next study. So, it remains to be seen if the previous study will even be completed during H2, and if so, will the final study be able to start immediately after it, still within this year? And if it does, will results be obtained before funds run out again in early H2 2026?
Overall, from this:
The results from the ongoing whole blood study using patient samples from St. Thomas’ Hospital are expected to be published before the end of Q2 2025 and represent a highly important milestone, as they could confirm the system’s performance on whole blood. Data confirming Psyros performance on whole blood has been requested by both the market and potential strategic partners. A positive outcome will be essential to advance toward a strategic partnership and enable completion of the full regulatory clinical performance study, which is expected to begin in the second half of 2025.
one gets the impression that the St. Thomas study was completed by the end of Q2 and the next study would have been ready to start immediately after, perhaps already during Q3. Such a procedure would probably not pass on the main list.
It probably wouldn’t make it to the main list, no.
Here is the schedule included in the investor presentation held at the end of last month on 24.6:
Pre-clinical validation studies are marked for H1 2025. Although it seems that St Thomas’ studies will continue for a while longer. Clinical validation is estimated to be 9 months long, and IVDR approval is hoped for in H2 2026. This would seem quite record-fast for a few-month IVDR approval, including the external evaluation of the application. This does raise a few questions. It somewhat suggests that they had to include somewhat optimistic figures to ensure the offering wouldn’t fail.
Well, as positive news: the stock has risen a nice 50% from the subscription.
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Did it eventually reach exactly 100% after all? Can it be possible? With what probability?
I don’t know. I initially interpreted that applications exceeded 100% and it was just capped at 100% according to the terms of the offering, but the wording suggests that exactly the missing amount of subscriptions without subscription rights were received.
In addition, applications have been received to subscribe for 149 686 965 shares without subscription rights, corresponding to approximately 29.8 percent of the Rights Issue.
That makes the situation sound like the subscriptions were almost full and someone who knew the number of available subscriptions decided to subscribe for the remaining shares at the last minute, with the share clearly being higher than the subscription price.
If the situation had been a clear oversubscription, the board would probably have already decided to distribute more shares with the authorization given to it by the general meeting, or we will get a press release about it on Monday.
NOTE: This post has been sitting in draft mode since August, and I only noticed it now. Some time has passed, so the information might be outdated.
Psyros is about to receive a new Europe-wide patent. I see this patent as quite significant; in general, the European Patent Office is very strict and demanding, and the patent description regarding the use of two different wavelengths sounds like something that is at the core of the entire technology’s physical operating mechanism. The fact that this “physical level” patent has moved forward is a pretty direct indication that Psyros’s technology is indeed unique.
Based on the patent application, Psyros’s technology is starting to become clearer to me as well. I have long wondered what ultimately makes Psyros so different if it ultimately uses bioluminescence. Well, now it’s starting to make sense:
In Psyros’s case, the use of these two lights is based on precise control of the reaction. The first light excites correctly bound reagent molecules into a special, temporary, and sensitive “excited state.” It’s about creating an extremely specific event and eliminating all possible false signals. This acts as a specificity filter. Next, a second light—to which only the correctly bound and activated reagent molecules react—triggers a permanent photochemical reaction, creating a measurable spot on the substrate, and this serves as a second specificity filter.
So now Prolight is getting a patent specifically for creating such a step-by-step process using light. This generally makes bypassing the patent very difficult.
Additionally, I learned that Psyros’s previous patents from another patent family (* WO2022123000A1 or EP4012423A1) protect these specific chemicals. Not just the specific molecules Psyros uses, but also similar molecular structures that function in the same way—specifically combination molecules where a photoactive reporter molecule is conjugated to an antibody or other sensor molecule. In other words, in addition to the technology, Prolight has developed its own chemical processes, and competitors would have to invent a very new or different molecular structure to produce reagents that function the same way.
Furthermore, Prolight’s patent family includes the manufacturing method for these molecules, test kits, the technology itself (optics and measurement devices), and the measurement process.
If this is the best-performing technology for measuring biomarkers, then this is quite a comprehensive and valuable stack of patents. And the patents effectively prevent third-party manufacturers from making test kits for Prolight’s devices. It’s starting to look like the devices will be sold very cheaply, and the profit will be made through test kits and high volume. Sounds like the printer business model already?
The stock market reaction is very moderate, but in light of this new understanding, I’m adding more “lottery tickets” to my portfolio.
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And then for a slightly more up-to-date situational analysis: the company has turned out to be a disappointment in my case. Schedules are slipping and there is still no information about the clinical trial. I would estimate that new share issues will be arranged by May at the latest, before the summer holidays. Unless a licensing agreement comes as a surprise before then.
According to the investor letter published yesterday, the “design freeze” for the device is still not completed and improvements are being worked on. However, for the assay unit itself and its reagents, this was achieved in December.
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Yesterday, an article was published with the headline “Prolight finalises instrument design and prepare for pilot manufacturing”. However, the article rather describes that the instrument is still being finalized, consistent with previous press releases.