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Hansa Biopharma

Hansa Biopharma AB: Hansa Biopharma announces positive Idefirix PAES results presented in the High-Impact Clinical Trials session at ASN Kidney Week

Hansa Biopharma AB: Hansa Biopharma announces Idefirix PAES late-breaking abstract selected for oral presentation in High-Impact Clinical Trials session at ASN Kidney Week

Hansa Biopharma AB: Hansa Biopharma announces submission of IND Application to US FDA for HNSA-5487 in GBS

Hansa Biopharma AB: Hansa Biopharma to participate in Virtual US Bancorp / BTIG Kidney Health Forum

Hansa Biopharma AB: Hansa Biopharma to participate in 26th Annual Biotech in Europe Forum

Hansa Biopharma AB: Hansa Biopharma Partners with Cradle to Advance AI-Driven Protein Design and Engineering

Hansa Biopharma AB: Hansa Biopharma Announces New Board Appointments

Bulletin from the Extraordinary General Meeting in Hansa Biopharma AB (publ)

Hansa Biopharma AB: Hansa Biopharma to participate in LSX Congress USA in Boston

Hansa Biopharma AB: Hansa Biopharma participating in Pareto Securities' 17th Annual Healthcare Conference 2026

Notice to Extraordinary General Meeting in Hansa Biopharma AB (publ)

Hansa Biopharma AB: Hansa Biopharma Announces Confidential Submission of Draft Registration Statement to the SEC to allow for a potential Listing of ADSs in the United States

Hansa Biopharma AB: Hansa Biopharma announces first commercial kidney transplant patient treated with Idefirix in Australia

Redeye: Hansa Biopharma (Q2 Review): SERB Deal Closed, December PDUFA Supported by Data

Hansa Biopharma AB: Hansa Biopharma Reports Second Quarter and First Half Year 2026 Financial Results

Hansa Biopharma AB: Hansa Biopharma to host Q2 2026 interim results conference call

Hansa Biopharma AB: Hansa Biopharma participating in Wedbush PacGrow Renal Summit

Hansa Biopharma AB: Hansa Biopharma announces closing of €115 million licensing transaction with SERB Pharmaceuticals for Idefirix in Europe and MENA

Hansa Biopharma AB: Hansa Biopharma announces ConfIdeS Phase 3 Abstract Selected for `What's Hot, What's New' Plenary at ATC 2026

Hansa Biopharma AB: Hansa Biopharma appoints Adam Cutler as new Chief Financial Officer

Hansa Biopharma AB: Hansa Biopharma invite to Capital Markets Day 2026 in New York

Hansa Biopharma AB: Hansa Biopharma appoints Fredrik Röök as VP Business Development

Hansa Biopharma AB: Hansa Biopharma participating in Jefferies Global Healthcare Conference in New York

Bulletin from the Annual General Meeting in Hansa Biopharma AB (publ)

Hansa Biopharma AB: Hansa Biopharma's CEO Renée Aguiar-Lucander named one of Sweden's Most Influential Business Women of 2026

NASDAQ Stockholm

Hansa Biopharma is a Swedish biotech company with the lead product imlifidase, which is an antibody-cleaving enzyme being developed to enable kidney transplantation in highly sensitized patients. The enzyme may be further developed for use in other types of transplantation, in autoimmune diseases, gene therapy and oncology. So far Idefirix (imlifidase) has been conditionally approved in the EU for highly sensitized kidney transplant patients.

Currently, Hansa is conducting a pivotal randomized contro trial in kidney transplantation in the United States and is expecting to commence a pivotal study across the U.S. and EU in the rare autoimmune disease anti-GBM during 2022. Additionally, Hansa’s research and development program is advancing the enzyme technology to develop the next generation of IgG-cleaving enzymes with potentially lower immunogenicity, suitable for repeat dosing in relapsing autoimmune diseases and oncology.

One can’t help but analyze this. Of individual companies, I have spent by far the most working hours on this, even though the result is meager. For instance, with the timing of Faron, Hims, and Optomed, I’ve succeeded significantly better than with holding this, but what can you do…  In any case, I ventured to make a small estimate of Hansa’s development over the next couple of years.  I assume here that in Europe, talk of an S-curve can be forgotten, and imlifidaasi sales will develop more linearly when viewed on an annual basis. At the quarterly level, there is so much fluctuation that an analysis is not meaningful. I also believe that peak sales in Europe for kidney transplants will remain significantly lower than analysts have predicted. In my opinion, Hansa’s development looks like a struggle for survival until 2027, but after that, the company still has a chance to meet expectations. I would see that, quite credibly, with US sales, there are opportunities for much better and faster success than in Europe, but that is a matter for a different review from 2027 onwards. Assumptions: Anti-GBM			Launch 2027  Kidney transplantation USA	Launch 2027  DMD			Launch 2027  GBS			Launch 2028 Product sales and revenue are assumed to grow trend-wise in 2025-2026 based on the development in 2021-2024. Additionally, the growth in revenue and product sales is assumed to transfer as such to profit and cash flow in 2025-2026, meaning costs remain unchanged. It’s difficult to see significant leaps in the next couple of years, but Sarepta’s milestone payments might bring “unforeseen” good, which may not be fully reflected here. On the other hand, total costs remaining unchanged is also quite an optimistic simplification, even if R&D costs might temporarily decrease slightly in the coming quarters. Things should then start happening in 2027-2030, but it’s a long way off. Of those 2027 launches, a few might, in the best case, be in 2026, but actual sales will likely only come in 2027 at best. Things can always shift further into the future. The cash position is indeed SEK 400m. Hansa still states that funding is sufficient until 2026. That doesn’t align with my analysis at all, meaning one of us is wrong. Hopefully me  Disclaimer: the analysis is entirely my own; errors may exist. Edit: I was still thinking about Hansa’s forecast for cash sufficiency until 2026 and the S-curve – which has now been removed from Hansa’s presentations. Here is a bullish version of the curves. Assumptions are otherwise the same, but here, the development between 2023-2024 has been emphasized, and an assumption has been made that sales development will continue to accelerate based on this, following an S-curve. I personally believe more in the first version, but it will be interesting to see which one 2025 follows.

Q2 2025. No major surprises, unless one counts the fact that the illustrative “Quarter on Quarter Performance” chart, which was included in the previous report, has been dropped from the report – perhaps it wouldn’t give a sufficiently positive picture of the development. So I compiled one myself, the result is below. Revenue 49.1 MSEK, almost entirely product sales (approx. 16 commercially treated Idefirix patients). Sarepta’s problems are likely reflected in the fact that there are hardly any contract revenues. During the period, a directed share issue of 232 MSEK was carried out, about half of which was consumed as cash flow during the quarter. At the same time, the NovaQuest loan restructuring was agreed upon. The development of cash flow (= costs) is, in itself, a positive aspect of the report.

Hansa’s Q1 2025 report is out. An hour before its release, CEO Søren Tulstrup was fired, effective immediately. Renée Aguiar-Lucander (Linkedin) starts as the new CEO and will already participate in today’s conference call.  Aguiar-Lucander served for seven years as CEO of Calliditas Therapeutics AB where she successfully led the company through a dual listing on NASDAQ in both Sweden and the U.S. During her tenure, the company successfully launched and commercialized the first ever approved drug for immunoglobulin A (IgA) nephropathy - -. Prior to that, Aguiar-Lucander had a long and successful career in the healthcare investment sector -  The Q1 result was not as terrible as one might have feared from the news of the CEO change, but it was by no means good. Revenue was 66.3 MSEK, which was almost entirely Idefirix sales. Commercially treated patients numbered approximately 22, which is certainly an increase from the previous quarter’s downturn, but otherwise quite flat compared to last year. Cash flow was negative by 151.9 MSEK, and cash reserves are now less than two quarters’ worth, i.e., 250 MSEK. The new CEO’s fundraising skills will be needed.              hansabiopharma.com              20250423-hnsa--q1-2025-quarterly-report-eng.pdf    1599.76 KB                                              hansabiopharma.com              Hansa Biopharma appoints new Chief Executive Officer | Hansa Biopharma

Anti-GBM (GOOD-IDES-02) pivotal phase 3 failed, Hansa announced this morning. Quite a big and surprising disappointment for me. This emphasizes that one cannot draw very big conclusions from comparisons to historical cohorts yet in phase 2, no matter how good it looks. The phase 3 primary endpoint (eGFR 6 months) did not differ in the imlifidase+SoC arm from control-SoC. Although imlifidase rapidly removed anti-GBM antibodies and approximately 60% of patients were dialysis-free at 6 months, the control group achieved almost the same level, resulting in no statistical difference. In phase 2, there was talk of a historical control group that achieved only about 20-25% dialysis-free status. A key reason why phase 3 “lost” to phase 2 is the study design: phase 2 was open-label, uncontrolled, and compared results to that (perhaps too loosely) selected historical cohort, whereas in phase 3, the standard of care was defined in the protocol as exceptionally aggressive (immediate and intensive PLEX + cyclophosphamide + steroids). This significantly raised the results of the control group and eroded the incremental benefit of imlifidase, even though the biological effect itself worked as expected. In other words, imlifidase did work, but when the disease was diagnosed quickly and aggressive SoC was started immediately in this experimental setup, there was no additional benefit from imlifidase. In practice, the regulatory pathway for the anti-GBM indication is non-existent after this, and the value of this indication can be set to zero in Excel.                   hansabiopharma.com              Hansa provides update on Pivotal Phase 3 trial in anti-glomerular basement...                                                clinicaltrials.gov              ClinicalTrials.gov

A rather weak Q3 from Hansa. One can probably already conclude that there simply isn’t a proper market for Idefirix in Europe for the kidney transplant indication. Revenue 30.8 MSEK, significantly less than a year ago. This corresponds to about ten treated patients. Sales in Germany are in trouble after Germany suspended its participation in the Eurotransplant prioritization program, and there are also problems in Spain. This also indicates weak future quarters. The “launch,” if the sales effort can still be called that, is thus going in the wrong direction in Europe. The cash situation is, of course, good after a directed issue made at a surprisingly good price. The issue raised 671.5 MSEK (71.5 MUSD) at the beginning of October, with a subscription price of almost SEK 40. The dilution with these issues is quite significant.  Quote from the Q3 report:  As mentioned in the Q2 report, the German Eurotransplant Prioritized Program has been paused, and as a result no product sales were reported in Germany during Q3. While physicians in Germany can continue prescribing IDEFIRIX under the standard Eurotransplant Kidney Allocation System (ETKAS), we expect that the pause of the prioritized program will continue to have a negative impact in the near- to mid-term.  This situation in Germany was explained in the Q2 Q&A session mainly by concerns in Germany about patient equality:  When it comes to these highly sensitized patients, you – they end up in this priority program for specific reasons. Let’s say, they’ve had a previous transplant, they have been pregnant, they’ve had a blood transfusions. You know the reason why they’re highly sensitized. And in Germany, what they have really been discussing is this health equity. That certain patients end up in this program.  Here, it seems to be implied that at least some patients are sensitized “due to their own reasons,” meaning they might not have properly managed their immunosuppressive medication with the first transplant or otherwise cause problems with their lifestyle. At least such a comment came from a German doctor earlier. Since kidneys are a very limited resource, they are preferably given to a non-sensitized recipient without the cost of Idefirix. This perspective is quite bad for Hansa. And there are also problems with Idefirix reimbursement in Spain. The story relies increasingly on the USA and, of course, on future indications in the development pipeline. Unfortunately, the FDA is also currently closed, which is unlikely to speed up the project… Fortunately, I realized at some point to start trading this – buying below SEK 30 and selling above SEK 35 has been a significantly better strategy than ‘hodling’ in recent years. At some point, this might still take off if the USA succeeds, and before that, it would be good to be involved if one believes in the story. After the Q3 report, we are at least back at buying prices. Of course, there is a lot of optimism in the report about the future and indications in the development pipeline, but in the short term, it left a rather melancholic feeling nonetheless.            hansabiopharma.com              hnsa--q3-2025-eng-final-1.pdf    2.07 MB

Hansa opened with a modest -25% decline after the auction following the Q4 report. Now it’s “only” -17%. The explanation is mainly only nine commercially treated patients and still a severely poor cash flow. Revenue 32.3 MSEK, cash flow -206.8 MSEK, cash 405.3 MSEK. Why wasn’t money raised after the good news in December or earlier last year? Now it has to be raised with a potentially quite modest valuation.              hansabiopharma.com              20250206-hansa-biopharma-q4-and-fy-2024-report.pdf    1431.99 KB                                              redeye.se              Hansa Biopharma: Ends 2024 on a softer note    After a period of steady increase in both European Idefirix sales and patient usage, Hansa records a softer Q4, with sales limited to SEK 25.6m.   Hansa does not expect to record any material provisi

Let’s post a summary of Q4 2025 here, even if it’s a bit late. For a change, it was actually a pretty good quarter. Revenue was 76 MSEK, of which product sales accounted for 61 MSEK, representing about twenty treated Idefirix patients. Full-year 2025 revenue grew by approximately 30% year-on-year. Q4 cash flow was still 178 MSEK in the red, and the full-year cash flow was -549 MSEK accordingly. Cash on hand was 701 MSEK.  Hansa gave guidance for a weaker Q1 2026 than the quarter just ended, and improvement could come in the latter half of the year. The US launch is planned for the end of the year (Q4), and hope for this was partly bolstered by Hansa reporting that the FDA accepted the BLA (Biologics License Application) for imlifidase on Feb 18. Personally, I only skimmed through this report, although I still have some kind of Hansa position in my portfolio. However, I spotted something in Redeye’s Q&A section, according to which Redeye does not see the shortage of donated kidneys in the US market as a similar constraint as in Europe. According to analyst Richard Ramanius, the target group for imlifidase is prioritized in the US: “Hansa has an advantage in that US decision makers prioritise highly sensitised patients because they want to reduce dialysis dependence.” Redeye has certainly been quite off the mark with its Hansa analysis so far, so it’s hard to say what value this statement holds. At least the analyst has changed now. Expectations still rest mainly on that US launch and the US market potential.            hansabiopharma.com              hnsa--q4-2025-eng-final.pdf    2038.10 KB

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