Earnings call transcript: Hansa Biopharma Q1 2025 surpasses expectations

Hansa Biopharma reported stronger-than-expected results for the first quarter of 2025, with earnings per share (EPS) significantly outperforming forecasts. The company posted an EPS of -0.55, compared to the anticipated -2.61, and revenue of SEK 66.3 million, surpassing the forecast of SEK 51.24 million. Following this positive earnings surprise, Hansa Biopharma’s stock surged by 7.62% in pre-market trading. According to InvestingPro data, the company’s stock has shown significant volatility, with a beta of 1.79, while trading near its Fair Value estimate.

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Key Takeaways

• Hansa Biopharma’s Q1 2025 EPS outperformed forecasts by a wide margin.
• Revenue increased by 18% year-over-year, driven by strong product sales.
• The stock price rose by 7.62% following the earnings announcement.
• The company projected a cash runway extending into early 2026.
• Positive developments in clinical trials and regulatory interactions were highlighted.

Company Performance

Hansa Biopharma demonstrated robust performance in Q1 2025, with a notable 18% increase in total revenue compared to the same period last year. Product sales, a key driver of growth, rose by 39% quarter-over-quarter. The company also reported a significant reduction in operating loss, showing a 71% improvement from Q1 2024. These results reflect successful restructuring efforts and expanding market uptake, especially in Europe. InvestingPro analysis shows the company maintains a healthy current ratio of 2.29, with liquid assets exceeding short-term obligations, though its overall Financial Health Score remains "FAIR" at 1.93 out of 5.

Financial Highlights

• Revenue: SEK 66.3 million (18% increase YoY)
• Product sales: SEK 65.7 million (39% increase QoQ)
• Operating loss: SEK 93 million (71% improvement YoY)
• Cash and cash equivalents: SEK 250 million

Earnings vs. Forecast

Hansa Biopharma’s EPS of -0.55 was significantly better than the forecasted -2.61, resulting in a surprise percentage of approximately 79%. This marks a substantial improvement over previous quarters and indicates strong financial management and operational efficiency.

Market Reaction

Following the earnings release, Hansa Biopharma’s stock experienced a 7.62% increase, reaching a price of SEK 22.3. This movement places the stock closer to its 52-week high of SEK 57.3. The positive market reaction reflects investor confidence in the company’s performance and future prospects.

Outlook & Guidance

Looking ahead, Hansa Biopharma remains focused on delivering key catalysts in the second half of 2025. The company is exploring opportunities for its product HANS-5487 in both acute and chronic settings, with potential U.S. market expansion on the horizon. The cash runway is projected to extend into early 2026, supported by continued expense management. InvestingPro data reveals the company’s rapid cash burn rate, with analysts revising earnings forecasts downward for the upcoming period. For comprehensive analysis including detailed financial projections and expert insights, explore the exclusive Pro Research Report, available to InvestingPro subscribers.

Executive Commentary

"We continue to make good progress across all eight active clinical trials," stated Hito Kaufmann, Chief R&D Officer, highlighting the company’s commitment to innovation. New CEO Rene Lukander expressed enthusiasm about leading Hansa Biopharma, saying, "I’m excited to join Hansa at this point of the company’s journey."

Risks and Challenges

• Potential regulatory hurdles for new product approvals.
• Risks associated with clinical trial outcomes and timelines.
• Market competition and pricing pressures in the biotech sector.
• Economic factors affecting healthcare budgets and reimbursement policies.

Q&A

During the earnings call, analysts inquired about the strategic rationale behind the recent CEO change and the potential for HANS-5487 in treating myasthenia gravis. Discussions also covered the commercial potential of the company’s post-approval study sites and challenges related to a possible U.S. dual listing.

Full transcript - Hansa Biopharma AB (HNSA) Q1 2025:

Conference Operator: Good day, and welcome to the Hansa Biopharma Interim Results and Q1 Earnings Conference Call. All participants will be in listen only mode. After today’s presentation, there will be an opportunity to ask questions. I would now like to turn the conference over to Peter Niklund, Chairman of the Board, Hansa Biopharma. Please go ahead.

Peter Niklund, Chairman of the Board, Hansa Biopharma: Good afternoon and good morning everybody. Welcome to the Hansa Biopharma conference call to review our Q1 results for 2025. I’m Peter Nicklin, Chairman of the Board of Hanze Biopharma. You’ll recollect in June this year, I actually reached my thirtieth anniversary as Chairman of the Board. Joining me today is Adam Valentine, Chief Financial Officer Hito Kaufmann, our Chief R and D Officer and Rene Lukander, our newly appointed CEO.

Before we turn to the Q1 results, you are most likely aware that earlier today, we announced the departure of Sjerdan Tolstorp, CEO of Hansa BioPharma effective immediately. Over the course of his tenure, whilst with the organization, Surin successfully navigated the company through several key milestones and financial rounds. The Board and I certainly appreciate his leadership and commitment to the company and wish him well for any future endeavors. Later in the call, we will hear from Renee, who has been appointed as CEO effective immediately. Today is her first day at Hanse.

And while she is in the room with me here, I trust that you’ll agree that it would be unfair to ask her to host this call with you today. So with that, please turn to Slide two. Please allow me to draw your attention to the fact that we will be making forward looking statements during this presentation, and you should therefore apply appropriate caution. Please turn to Page three. Today, we will discuss the progress we have made during Q1 and review the quarterly performance.

The presentation will take roughly fifteen to twenty minutes, after which there will be an appropriate open opportunity to ask questions during the Q and A session. Please turn to chart four. In Q1 twenty twenty five, total revenue reached SEK66.3 million, including Idifarec sales totaling million. This represents a 39% product sales increased over the prior quarter. Please remember, Q1 twenty twenty five represents the final negotiated lower pricing in certain markets in comparison to the Q1 twenty twenty four.

We are encouraged by continued growing European market uptake seen in Q1, reflecting the increased number of transplant clinics with initial and repeat usage of IDEFREX and growing clinical consensus on the appropriate use of IDEFREX as desensitization treatment for highly sensitized patients as demonstrated by consensus and clinical guidelines being published at both the international and local market level. Please turn to Slide five. Thank you. We continue to make good progress with the pipeline and are working towards several key catalysts in the second half of twenty twenty five. In the quarter, we announced the completion of enrollment of patients in the post authorization efficacy and safety or PES study Phase three study in Europe.

As a reminder, the trial is part of our obligation to EMA based on conditional approval of IDEFRIX in Europe. We’ll talk more about the study in a moment. During the quarter, we also had positive regulatory agency interaction with BFAAM, the Federal Institute for Drugs and Medical Devices in Germany and gained alignment on a proposal on a proposed clinical trial in myasthenia gravis for HANS 5,487, our next generation molecule with redosing potential. There is high unmet need for better options to treat acute phases of this disease, and we believe that HANS-five thousand four hundred eighty seven has the potential to address this. Hito will share more on this later on in the presentation.

As we look ahead in 2025, we turn our focus to delivering several key catalysts, including data from the Phase III GOODIDIS-two study in anti GBM and The U. S. Phase III CONFIDIS study in kidney transplantation as well as data from the Phase II EDIS trial with our partner Geniton in Krigida Najed syndrome and presentation of the data from the Phase two-nine trial in Guillain Barre syndrome, as we call it GBS. We also expect data from the Phase 1b Sarepta study with our partner Sarepta in Duchene muscular dystrophy, which has enrolled the first few patients. Currently, several EDITUS trials are temporary halted due to the EDITUS safety update in March, including the Sarepta nine thousand and oneone hundred and four study that we are involved in.

An independent review committee occurred that concurred that overall Edivitas benefit risk profile remains favorable. And importantly, no material impacts are anticipated on the time lines of these studies. Before moving to the next slide, I’d like to highlight our ongoing efforts to publish and present our science to the scientific and clinical community. Importantly, there have been several new international and market specific clinical consensus guidelines recently published on the appropriate use of amlifidase as a desensitization strategy in highly sensitized kidney transplant patients. This underscores the increasing awareness and belief by the clinical community in the benefits of omelifidase in desensitization.

I’ll ask you to turn to Slide six, please. The next slide. Thank you. In Q1 of twenty twenty five, we completed enrollment of patients into the PEDS study in Europe. The study is part of the company’s obligation under the European Conditional Marketing Authorization following conditional approval of Edifarix in 2020 by EMA.

The study remains on track to readout in the second half of twenty twenty six and is intended to support full marketing authorization in Europe at that time. 22 transplant centers were part of the trial with 14 centers having treated a total of 50 transplant patients. This is important because it means that participating centers now have both the clinical experience and protocols in place to treat highly sensitized kidney transplantations in future. We believe these key participating centers will continue to utilize Adeferix to desensitize appropriate patients now converting to commercial product and thus contributing significantly to continued product sales growth and most importantly, ensuring even more patients will have access to this innovative desensitization therapy and a potential life saving kidney transplant. Just this week, Ascentra in Italy that participated in the PED study transferred its first patient to commercial Edifferix.

As indicated on the slide, the next step is to complete the twelve month follow-up in 2026 followed by submission to EMA to enable full approval. I’d ask you to turn to the next slide please. As stated previously, we continue to make solid progress with the commercialization of Edifarix in Europe. In the quarter, we saw four additional transplant clinics gaining an initial experience with Edifarix. And the number of clinics with repeat usage following a successful first experience continues to grow.

Our engagement with European key opinion leaders and medical societies is underscored by the continued publication of new consensus and clinical guidelines on the appropriate use of amlifidase in desensitization of highly sensitized kidney transplant patients. Just this quarter, we saw new international consensus guidelines published in the journal Transplantation Direct and also new national guidelines issued in Spain. Finally, during the quarter, we secured access in three additional European markets and the Difference is now reimbursed in a total of 18 countries, including the first the five largest European markets. Yesterday, we also learned that we now have reimbursement in Switzerland, underscoring continued advancements of reimbursement in markets throughout Europe. I would now like to turn to Hito for an update on the progress that we’ve made with our pipeline projects.

Peter, over to you.

Hito Kaufmann, Chief R&D Officer, Hansa Biopharma: Thank you, Peter. Please turn to Slide nine for an update on the pipeline and clinical development highlights to date. As you can see, we continue to make good progress across the pipeline in all three therapeutic areas. And in the fourth quarter, we shared several updates in both the autoimmune and gene therapy areas. I’ll now walk you through some of the specific trials and studies we have been going and the clinical development plans we have in place.

Please turn to Slide 10. I’m pleased to share that we continue to make good progress across all eight active clinical trials. And as you can see on the right and as Peter has mentioned previously, we have several key catalysts in the second half of the year. In 2025, there have been six peer reviewed journal articles on elifidase including two on the 17H MET ITAS S14 study, which is the five year data we have shared previously. Of note, we had positive regulatory agency meeting with B Pharm on the development path for HAMSA five thousand four hundred eighty seven, our next generation molecule with redosing potential.

The meeting confirmed the suggested clinical trial design in myasthenia gravis, an indication with a new rim homogeneity. We aligned on investigating the safety and efficacy of HANSV-five thousand four hundred eighty seven in myasthenia gravis patients, utilizing short and long interval redosing at two dose levels. This approach will facilitate reliable and fast recruiting. Furthermore, we received confirmation on meaningful efficacy endpoints included patient reported outcomes such as the MG specific activity of daily living scale, MG ADL and physician reported outcomes like the quantitative MG scale, QMG. I’m incredibly pleased with the team’s work to get us to this point and look forward to sharing more in due course.

We announced positive results in October 24 regarding MINCE-one, the first in human trial and findings from a twelve month analysis of that data for HMV-five thousand four eighty seven. The analysis demonstrated that HUNDR5487 can robustly and very rapidly reduce IgG levels, has redosing potential and a favorable safety and tolerability profile in study subjects. We continue to believe HUNDR5487 has a highly differentiated profile compared to published data from studies with other IgG targeted therapies. Additionally, I’m pleased to share that data from the 15H Meditis nine Phase two study of emlysidase in Guillain Barre syndrome, also known as GBS, has been accepted for presentation at upcoming medical congress. We look forward to sharing this data with the clinical community.

It’s worth mentioning that we are hosting a virtual science deep dive discussion on June 16 at two p. M. Central Eastern Central European Time and eight a. M. Eastern Time on GBS.

This is part of a larger series of deep dives we plan to hold throughout the year. The intention is to discuss the current diagnosis and treatment of GBS as well as the existing unmet need that exists for patients and clinicians. I’m thrilled to be joining my colleague, Elizabeth Sonnissen, Global Franchise Lead, Autoimmune at Hunter as well as two key opinion leaders, Doctor. David R. Komber, MD with Johns Hopkins University and Simon Renaldi, MRCP, PhD with the University of Oxford.

Registration is required for this event and can be found on our website. We hope you can join us. We anticipate that we will also have data from the GOOD Phase III trial in anti GBM. As a reminder, the GOOD IDES-two trial is a Phase III open label controlled randomized multicenter trial across Europe and The U. S.

And is evaluating renal function and the need for dialysis at six months in patients with severe anti GBM disease. Encouraged by our Phase II data, we believe outcome of these patients and address the unmet medical need. Amlifidase has been granted orphan drug designation for the treatment of MTGBM disease by both the U. S. Food and Drug Administration and the European Medicines Agency.

Later this year, we anticipate that from GMT018itis, a Phase II trial in patients with Krigtner Najjar syndrome with the preexisting antibodies against adeno associated virus vectors or AAV, the trial will evaluate efficacy and safety of a single intravenous administration of Genitom’s gene therapy, GNT003, following pretreatment with emlifidase. GNT-three zero three is currently being evaluated in a pivotal clinical study in France, Italy and The Netherlands and has received prime sales from the European Medicines Agency. As Peter mentioned, several Elevator studies have been temporarily halted due to a safety update provided in March. We look forward to continuing our collaboration with Sarepta on FRP-nine thousand and one-one hundred four. Importantly, Sarepta does not expect a material impact on the timelines for these studies.

And based on the findings from an independent data review committee, the benefit risk profile remains favorable to continue dosing in the paused trials without changes to study protocols. Finally, the CONFIDENT U. S. Pivotal Phase III trial was fully randomized in May 24 and we plan to deliver data in the second half of twenty twenty five followed by a BLA submission to the U. S.

FDA. Please turn to Slide 11 for a summary of long term data and various publications. The 17h MEDIDUS-fourteen study is a prospective observational long term follow-up study of patients treated with amethodase prior to kidney transplantation to measure long term graft survival in patients who have undergone kidney transplantation after amethodase administration. Importantly, trial data was pooled with data from four Phase II trials and showed sustained positive outcomes out to five years in most highly sensitized patients who received an amelicidase enabled kidney transplant. The five year extended pooled analysis is a continuation of the analysis at three years of cross match positive only patients.

The pooled analysis showed sustainable positive outcomes out to five years in most highly sensitized patients who received an emulsifieds enabled kidney transplant. After five years, patient survival rate was ninety percent and graft survival was eighty two percent, in line with outcomes seen at three years post transplant. At five years, mean estimated glomerular filtration rate eGFR was 50 ml per minute per square meter. EGFR is a measure of how well the kidneys are working in the body. The extended pooled analysis has been published in several key journals and presented at key medical congress.

We continue to look for ways to share this important long term data with the community. I will now turn the presentation over to Evan to cover financial performance.

Evan Valentine, Chief Financial Officer, Hansa Biopharma: Thanks very much, Ito. Let’s walk through the company’s financial performance for Q1 twenty twenty five. Can we go to the next slide? Total revenue for Q1 twenty twenty five was SEK66.3 million, representing an 18% increase compared to Q1 twenty twenty four of SEK56 million. Product sales for Q1 twenty twenty five were SEK65.7 million, representing a 39% increase as compared to Q1 twenty twenty four.

Additionally, this represents a significant increase over the previous quarter. As Peter mentioned, we continue to see fluctuation in our performance quarter over quarter. However, it should be noted that year over year performance continues to increase. Quarterly volatility reflects the unpredictability of the organ allocation market. We expect this fluctuation to diminish over time having completed the post approval efficacy study and as Hanza continues to enter new markets.

If we go to the next slide. For Q1 twenty twenty five, SG and A expense totaled approximately million, which was 16% favorable to the prior period. Restructuring activities helped to reduce total year over year SG and A expense. R and D expense in Q1 twenty twenty five totaled approximately SEK64 million and were 38% favorable compared to Q1 twenty twenty four. The favorable decrease in R and D expense was primarily driven by restructuring actions.

In Q1, net financial income and expense represented income of approximately SEK 57,000,000 in contrast to an expense of SEK 59,000,000 in Q1 twenty twenty four. Changes in financial income and expense are primarily driven by non cash expense related to the NovaQuest note and changes in the U. S. Dollar exchange rate against the Swedish krona. In Q1 twenty twenty five, the operating loss of approximately SEK93 million was 71% favorable compared to the Q1 loss of SEK159 million.

The improvement in Hans’ operating loss compared to the prior year was driven by increased sales and an overall reduction expense, a very positive trend. Please go to the next slide. Cash used in operations in Q1 twenty twenty five totaled million. In Q1 twenty twenty five, cash and cash equivalents totaled SEK250 million. As we mentioned in the Q1 earnings report, given the priorities and projects, the company anticipates a cash runway into Q4 twenty twenty five.

Further expense management would allow the company to extend its cash runway into early twenty twenty six. And now, I would like to turn the presentation back to Peter for closing remarks and for the Q and A portion of the call.

Peter Niklund, Chairman of the Board, Hansa Biopharma: Thank you, Evan. With this overview, our presentation is now concluded. I would like to mention that we are postponing the upcoming AGM that had previously been scheduled for June 4 to a later date in June. We will share the new date with you in due course. And if there’s questions around that, obviously, the main reason for it is the newness of Renee to our team to give her a little bit more time before an AGM were to take place, which I trust you understand.

I would like to take the opportunity to welcome Renee now to the company as the new CEO of Hansa Biopharma. Renee, would like to say a few words?

Rene Lukander, CEO, Hansa Biopharma: Sure. Thank you, Peter. I’m very excited to join Hansa at this point of the company’s journey. I hope to bring some relevant experience and insights to the table, and I really look forward to engaging with all stakeholders once I’ve had some time to review and assess the product pipeline and organization in some more detail. I look forward to bringing you all some updates, if not earlier than certainly in the Q2 report.

And with that, I turn it back over to you, Peter.

Peter Niklund, Chairman of the Board, Hansa Biopharma: Thank you, Renee. Let’s now turn to questions. I’m sure many of the listeners may have by now. Operator, can you please begin?

Conference Operator: Yes. Thank you. We will now begin the question and answer session. And the first question comes from Suzanne van Voorheisen with Kempen.

Suzanne van Voorheisen, Analyst, Kempen: Hi, there. This is Suzanne from Kempen. Thanks for taking my questions. Maybe first on the CEO change. Of course, a warm welcome to Rene.

I’m looking forward to work with you again. But if possible from the Chairman, I would like to hear more on what were the drivers behind this change in leadership as it’s effective immediately. Some color will be helpful. And then from Rene, I’m curious to hear what you see as the biggest opportunities and the biggest challenges for Alka you wish to tackle better to later. And then I have some questions on the programs as well.

Thank you.

Peter Niklund, Chairman of the Board, Hansa Biopharma: Thank you, Suzanne, for the question. And I hadn’t realized you’d worked with Rene before, but that’s good news. Okay. I’m sure there are others on the call too. The reasons for the change, the drivers for the change, and obviously, I’m not going to go into specifics concerning individuals and various performance characteristics of old and new, but I will talk in general terms.

I mean, Southern was with the business for seven years. He led the business, as I said, successfully through a period of preapproval. He took it through approval here in Europe. He launched the product here in Europe, and he continued to advance the science of the business. And we look back at those seven years of dedicated work and thank him for that period.

However, every business and certainly all the businesses I’ve been involved, that’s the right time for leadership for different styles of leadership. And I felt together with my Board and then discussion with some of our investors as well that it was time for a change of leadership of the company, maybe a somewhat different approach to the leadership, and this was the right thing to do. Obviously, we considered a number of candidates in the process. And when I met Renee and others of my Board met Renee as well, we were all convinced unilaterally that she would be the right person to take the company forward. And it’s never done lightly.

And I can tell you, as many hours of good discussion on this topic, all considerations and so on. As I say, it’s never a great time to change CEO, but I think at this time, this is very much the right thing to do, and I’m convinced Renee is the right leader for this business going forward.

Rene Lukander, CEO, Hansa Biopharma: Hi, Suzanne. I look forward to working with you too. So in terms of kind of the opportunities and challenges, so I think that there’s nothing new under the sun. As you know, I think I have strong affinity to rare diseases in general. Hanzo obviously had it’s a late stage opportunity, really having two Phase III readouts expected in the second half of this year.

I think that there is an attractive commercial potential in The U. S, both for kind the existing commercial product in Europe, that type of but also for other kind of rare diseases. So kind of autoimmunity really in general. And obviously, I think there is also a highly interesting potential in gene therapy that I think needs to kind of be explored further and with more depth. And then obviously there is a maturing kind of European commercial footprint as well.

So I think that this really kind of has a significant number of opportunities and potentials to play with and really develop and grow. And I think that’s kind of ultimately what attracted me to this particular opportunity. In terms of challenges, I think that they are also kind of pretty obvious. I think every time we kind of open a newspaper or look at any screen in this kind of day and age, I think that there obvious challenges in the kind of macro environment, whether that is rates or tariffs or FDA or resources. I mean, I think there’s just a generally very, very high level of uncertainty.

And as we’re all familiar with that, that kind of generates kind of unproductive capital markets settings. And so I think that’s clearly, I think, a challenge for the company is really to kind of ensure that there is sufficient funding in place. But also, I think that the company has a sustainable kind of base operation going forward that’s appropriate in terms of kind of cost base. I also think that there are opportunities here to work with partners, whether that is out licensing on a geographic basis or other kind of opportunities, but I think there are quite a lot of other opportunities as well to kind of draw upon in order to secure kind of that stable kind of sustainable operating environment.

Suzanne van Voorheisen, Analyst, Kempen: Got it. Thank you. That’s very helpful. And maybe on the programs on the repeat dose program 05/1987, there’s a plan to start a study for the indication of MG crisis. Broken up for a second, so apologies if this was already covered.

But can you recap where you stand in the process in terms of regulatory feedback, study design thoughts and when you expect to start the study? And then my last question is on the Phase II kidney readout that we’d like to cover over the summer. What level of data disclosure should we be expecting when the top line release will be there? Will this be only whether the primary endpoint was met? Or where will there be an actual eGFR effect in numerical terms also be shared?

Thank you.

Peter Niklund, Chairman of the Board, Hansa Biopharma: Thank you, Susanne. I will pass this to someone with far more expertise on the detail than I have to Ito, who’s on the call. So Ito, could you please take that question?

Hito Kaufmann, Chief R&D Officer, Hansa Biopharma: Sure, Peter. Hi, thanks for this question. 05/1947, we are very happy that we have this very constructive and productive scientific advice exchange with BPharm. And that was in particular important for the design of the Phase Ib study in myasthenia gravis that we anticipate to start as the next step in our clinical development plan. Here, the important thing was that we got confirmation on the two dose levels we want to investigate.

We got a confirmation on the patient population that we want to dose emulsidase five thousand four and eighty seven with and the dosing regime because we want to look at short and long term interval redosing. And last but not least, we had a very productive confirming exchange on the endpoints that we suggested to be firm. Next step, we’ll be starting the trial. We’re not yet guiding on the specific starting date, but that will probably follow very soon. Then I understood you asked also about the CONFIDUS trial.

As there’s no change in guidance, the trial is progressing as planned. And the last randomization happened the May. And it’s a one year readout. And we expect late summer to have top line data available. Now you commented on endpoints.

What you can expect is a very, very strong focus on EGFR as the primary endpoint, especially since many of the secondary endpoints are highly linked to EGFR.

Suzanne van Voorheisen, Analyst, Kempen: Got it. Thank you.

Conference Operator: Thank you.

Peter Niklund, Chairman of the Board, Hansa Biopharma: Thank you, Suzanne. Thank you, Suzanne for your questions. Next.

Conference Operator: Thank you. And the next question comes from Douglas Tsao with H. C. Wainwright.

Douglas Tsao, Analyst, H.C. Wainwright: Hi, good morning. Thanks for taking the questions. I guess, Peter, maybe this is a starting point in terms of the change in leadership. I’m just curious, was it a sort of change in terms of the direction of the company and sort of the strategic prioritization? Or did you see alignment on that?

And it was just a question that the company wasn’t achieving those objectives, as quickly as you thought was needed, especially in light of the current environment.

Peter Niklund, Chairman of the Board, Hansa Biopharma: Yes. Thank you for question.

Hito Kaufmann, Chief R&D Officer, Hansa Biopharma: It’s it’s kind of a little bit

Peter Niklund, Chairman of the Board, Hansa Biopharma: of all of the above, okay? So that doesn’t answer your question. So I think the from a strategy point of view, let’s start there at a high level, okay? What I would expect of the Nay, and obviously, we have discussed several occasions, is a how would I say a thorough thoughtful process of looking at existing strategy and where we place our emphasis in future or don’t place our emphasis in future. You bring in a new CEO not to continue everything that you’ve done before, but you bring in a new CEO to reconsider and ensure either we’re on the right path or we need to deviate from that path, either small or significantly.

And we don’t know the answer to that frankly now. And to ask Renee, after whatever it is, six hours in the office this morning, what that is would be very unfair. So and there is no pre agreed plan with Renee to strategically completely change the direction of the company. So on that hand, I would ask you all to just bear with Renee a little while. It is clearly a top priority for her to ensure that we are on the right path.

And if not, then of course, will communicate otherwise. Regarding other things, I mean, a seven year tenure in a tough environment is we have everybody who’s ever done it before here, and Renee, you did it seven years in your previous company, has done it in other places. There’s wear and tear involved as well, right? So I think the clearly, we’ve not seen the results that we were all hooping to, okay? And you can look at the outside markets and say, the tide’s out and tide’s low.

So when the tide’s low, all boats come down. But that’s one point. But at the same time, we clearly haven’t been recognized for the work that was done for whatever reasons. And maybe bringing in a new CEO with a different experience, okay, by far. Rene comes from a very different background, as you guys know.

Maybe bringing in someone with different experience, a different style is the right thing for the company. And after considering that, we felt that Rene does bring that different perspective that we would expect and different style to the company right now, okay? So as a right leader for the right time, and we think that Rene is that person. So I hope that answers. So strategy, at this point, too early.

But leaving strategy aside, just from an individual point of view, we think that Rene is suited to take the company forward.

Douglas Tsao, Analyst, H.C. Wainwright: Peter, that was a very helpful answer and greatly appreciated. And then just a follow-up question to HITO in terms of 5,487. And when you think about the development of that asset and need for repeat dosing obviously, repeat dosing is the goal for the program. I’m just curious when we think about, say, an indication like MG where you treat MACUSAs, it’s likely that there may be a change in that patient’s treatment. And so is it practical to think that you would be able to have patients need multiple doses within a reasonable amount of time.

And so just sort of thinking conceptually like a patient who might be on sort of immunosuppressants, mycophenolate as an MG crisis, enrolls in the study, gets treated with five thousand four hundred eighty seven, but then they come out on the other side. There’s a good likelihood that they’re going to change their ongoing chronic treatment, perhaps go to an FcRn inhibitor where the likelihood of a crisis might be reduced. And so I can see the treatment and demonstration of efficacy in that initial crisis. Do you need to treat multiple crisis or is there another way to get assurances around safety for BP dosing?

Peter Niklund, Chairman of the Board, Hansa Biopharma: Yes. Thank you for that question. And given the science and nature of it, I’ll pass it clearly to Heeter.

Hito Kaufmann, Chief R&D Officer, Hansa Biopharma: Thank you for that question. Starting statement is, obviously, we’re at the beginning of the clinical development of five thousand four and eighty seven in my patients. So that’s the sort of the frame for my answer. What we hear very clearly from all KOLs we talk to and certainly from the ones that have been intimately involved in the design of our next studies is that despite progress on maintenance therapies, there is still a significant unmet medical need for reoccurring acute phases of myasthenia gravis. And when you talk to people in the clinical center, the number of patients that come back to the clinic with these acute phases, some of them ending up in myasthenia crisis, that hasn’t changed.

So that unmet medical need is there. And then, of course, that’s why in our upcoming study, we want to investigate initially also the safety of this repeat dosing paradigm. The patient population we haven’t discussed now with health authorities for the Phase 1b trial is a patient population that has symptoms under are stable, but has symptoms under immunosuppressant treatment that allows us to also pick up, if possible, up some signals on efficacy as well.

Douglas Tsao, Analyst, H.C. Wainwright: Okay. Thank you so much.

Peter Niklund, Chairman of the Board, Hansa Biopharma: Thanks very much. Next question please.

Conference Operator: Thank you. That comes from Matt Phipps with William Blair.

Chris Udu, Analyst, SEB: Hi, this is Eric on for Matt Phipps. Just two questions, maybe first one for Renee. So firstly, congrats. Looking forward to your leadership here at Honsa. Just wondering what attracted you to the Honsa opportunity?

And just initially, how do you prioritize Adafir’s expansion versus some of the opportunities for 05/1987? And just secondly, I was wondering on potential next steps for the GBS program.

Suzanne van Voorheisen, Analyst, Kempen: Okay.

Rene Lukander, CEO, Hansa Biopharma: So I think what attracted me to the company is the I do have a soft spot in my heart for rare disease. And I am really looking forward to kind of really engaging with patient organizations and really looking at kind of where there is really truly kind of significant unmet medical needs that Hansek can really address effectively. The fact that the company is late stage in terms of having the Phase three readouts kind of coming up in the second half of this year, that obviously leads to a situation where I think I have relevant insights and experience in terms of all of the kind of regulatory, the pre commercial, the medical affairs, the kind of building of a commercial footprint, accessing The U. S. Market, etcetera.

And obviously also because the company really today has all rights for all regions across the portfolio. There is also obviously opportunities, I think, to kind of broaden the potential access to patients in other geographies in different ways. Then obviously, there is the there’s kind of the European commercial opportunity or footprint that’s already kind of in existence. So I think that all of these things really kind of, I think, is a great opportunity to create significant value on the basis of this platform, the science, the technology. And I think that in terms of any kind of new kind of, what do you call it, life cycle management, call it kind of new and other kind of related to kind of the Emilisa days.

I think that that really is an area where like where I will spend some time. I’ll spend time in a lot of different areas, but I think that obviously is going to be part of kind of that in-depth review that the team and I will kind of go through in terms of really assessing what area or what indication or how does Hannesa really kind of most effectively compete and really dominate in some of the kind of chosen areas. And so I think that’s really kind of one of the exciting parts of kind of coming into a late stage business like this is you get the opportunity to learn from the team that’s here and to really kind of go through a very rigorous kind of process in terms of strategic options and opportunities. And I think that with all of these things that are going on, I think that there is a lot of areas for us to kind of pursue and look at and really clarify kind of where should Hansa really kind of spend its time, what should be the focus, how can we really kind of be as successful as possible in the areas that we choose to pursue.

And I think in terms of the GBS, I think that probably goes to Hito to answer.

Hito Kaufmann, Chief R&D Officer, Hansa Biopharma: Sure. Thanks, Rene. GBS, just as a reminder, we the last guidance we gave was on the contextualization of our Phase II data with the IGOS database and showing like significant differences in the speed of recovery of these GBS patients when we compare to our arm, single arm study for Phase II with enlifidase followed by IVIG treatment. What we are currently disclosing about the Phase III design is that we intend to compare in the active arm elicidase followed by IVIG to an IVIG control arm because in both key geographies in Europe and in The U. S, this is what the feedback we get from KOLs, from regulatory authorities.

We’re not guiding anything beyond that at this point.

Chris Udu, Analyst, SEB: Great. Thank you so much.

Peter Niklund, Chairman of the Board, Hansa Biopharma: Thanks very much, Eric.

Conference Operator: Thank you. And the next question comes from Chris Udu with SEB.

Chris Udu, Analyst, SEB: Hi, there. Thanks for taking my question. So first, I’d like to start by saying congratulations to Hansa on, I think, very exciting and serendipitous appointment of Rene as CEO. And congratulations also to you, Rene. Thank you.

So my question my first question is, they’re both about strategy. And I guess, Renee, you have experience of dual listing. We’ve heard in the past on multiple occasions that Hansa is looking to explore a dual listing or intends to do one. But, of course, we’ve seen I think the evidence is quite clear that it’s not necessarily the answer to or a way to actually increase share prices by having a secondary listing in The U. S.

Can perhaps Peter and Rene comment on your thoughts around why that might be different for Hansa or if you are still planning to do that or what your thoughts are? So that’s my first question. Thank you.

Peter Niklund, Chairman of the Board, Hansa Biopharma: Yes. Thanks very much for the question. And, clearly, has been discussed between myself and Renee, but I’ll let Renee answer the question.

Rene Lukander, CEO, Hansa Biopharma: So I think that under the present circumstances, there’s really the capital markets in The U. S. Seem pretty shut in general for like U. S. Companies doing any IPOs.

And if that’s the case, then obviously, there really is no ability for kind of a European based company, in my view, to do an IPO in The U. S. Market. So for now, I don’t think that that’s really on the drawing board in terms of doing that kind of right now because I just don’t think that that market is available. I do think that at the end of the day, one hopes that at some point in time, the VIX will decline, things will become a little bit more stable, a little bit less uncertain.

And then I think it’s really a matter of kind of looking at where is the capital for the company that makes most strategic sense. If that happens to be in The U. S, then I think that that’s obviously kind of a reasonable place to go. And if it’s here, then that’s perfectly fine too. I do think in terms of having a dual listing, I would agree with you.

I think that having a dual listing with a view of saying that you only do a dual listing to achieve kind of an increase in share price. I don’t think that that’s necessarily the case. I think there are operational reasons for doing some of these things. And but again, I think at the end of the day, it comes down to where do you have the demand and the understanding and the will to support some of the biotech companies in the sector. And I think at this point in time, obviously are going to have to go to wherever that capital is available and live with whatever consequences that might come with at the present circumstance.

But I think in principle, I would say that I think it would be extremely challenging for any European biotech company to kind of explore a U. S. IPO at this stage.

Douglas Tsao, Analyst, H.C. Wainwright: Yes. Thank you

Chris Udu, Analyst, SEB: for that thoughtful answer. And a second question then is around the 5,487 NYSER program. So I’m going to ask, I guess you, Peter, this because I haven’t been so satisfied with the responses I’ve had in the past. When it comes to the choice of acute versus chronic, and I heard you talk about your plans to reappraise the strategy in its various forms. But up until now, you’ve been talking about a focus on acute care settings.

But the lion’s share of the opportunity is obviously also straddling chronic. And we have a competitive space increasingly competitive space in IgG degraders. So is this something that you’re going to reevaluate? And if not, would you please clarify why you don’t see that as a good avenue to go down, given that we have a two week window where it’s possible to before you have too high IgG to prevent that from happening? And secondly, because you might be able to induce tolerization?

Thank you.

Peter Niklund, Chairman of the Board, Hansa Biopharma: Yes. Thank you. It’s a good question. I would I will ask Hito to answer, and I hope that your reference to not getting a good answer was not to Hito. Otherwise, I’ll take it back.

But, what I would say is just an overall comment, we should first learn to walk before we start to There’s still work to be done in my mind before we can determine what that approach should be. Pavitha, I will pass to you, if I may.

Hito Kaufmann, Chief R&D Officer, Hansa Biopharma: Sure. Thanks. Peter. Five thousand four hundred eighty seven is in terms of efficacy currently from what we see in the in vitro experiments extremely comparable to in the today, meaning that within hours, it reduces IgG levels to less than 5%. Our initial step into new autoimmune diseases is a step into chronic indication to cover, hopefully, if the clinical data support this, repeat acute phases.

By doing this, we will establish a profile, including a safety profile for repeat dosing. And of course, our strategic long term view includes chronic settings in chronic diseases, and we hope to learn. But it’s also fair to say that at the moment, it’s not really clear what a safety profile will look like if you would dose for a very long time with IgG clearing enzymes that bring down IgG levels to less than 5%. Other IgG, I would say, reducing technologies, wouldn’t necessarily call that degrading technologies, bring IgG levels down to something like 30%, forty %, which is, of course, clinical at different stage. There’s a huge space to explore.

I think we have a key angle on it. And I would hope that the more clinical data we get, the more we can expand on that theme.

Chris Udu, Analyst, SEB: Thank you very much. That’s all for me.

Peter Niklund, Chairman of the Board, Hansa Biopharma: Okay. Thank you.

Conference Operator: Thank you. And we have a follow-up question with Douglas Tsao with H. C. Wainwright.

Douglas Tsao, Analyst, H.C. Wainwright: Hi, good morning. Thanks for taking the follow-up. Just a quick one for me. Just thinking about commercial performance with the post approval study completed in Europe, I’m just curious, would you expect to see similar commercial adoption as that study enrolled? Or do we think about the 177 consented patients perhaps as a better benchmark?

Or was that simply a clinical trial and so that there were some sort of restraints on use of the technology? And that now that it’s those centers have access to it or can just use it on a commercial basis, do you think there might be an increase in use in those at those sites? Thank you.

Peter Niklund, Chairman of the Board, Hansa Biopharma: Thank you for the question. It’s a good question and the answer may be a little bit speculative because we but you’re asking it right, what do we expect to see? Obviously, it will show. Hito, do you want have a go first and then maybe I can follow-up?

Hito Kaufmann, Chief R&D Officer, Hansa Biopharma: Sure. I think the way you worded it is entirely correct. We have to look at this, I would say, the acceleration of our launch through the PS sites, not only from the angle of how many patients have they treated, but also how many patients have they consented. There are a number of sites. There’s 14 that have enrolled patients, but there’s, in total, 22 sites.

I think it’s too early to really say, but I would also think it’s fair to say we say we see early signs of these PAS centers, especially in countries like Italy and Spain, to help accelerate our commercial read through.

Rene Lukander, CEO, Hansa Biopharma: Helpful. I mean, I think I would add to that just a general comment, not specifically on this program because I don’t have the knowledge to kind of comment on this specifically. But I think that in general, I don’t think one should underestimate the very big value of kind of having access to additional data, long term data, follow-up data, any kind of real world data kind of out there or it’s in a clinical trial, but still it’s I do think that this I mean, a lot of the kind of communities, physician communities in Europe are quite conservative. And I think having a full approval versus a conditional approval, I don’t think one should underestimate that. And I also think that just having access to this type of data is hopefully obviously going to kind of further just support why this is a very, very important kind of alternative for these types of patients.

So I think irrespective, again, I don’t think one should underestimate the potentially positive impact on the kind of community as a whole from publishing and sharing this type of data.

Douglas Tsao, Analyst, H.C. Wainwright: Okay, great. Thank you very much for those added thoughts, Renee.

Conference Operator: Thank you. And this concludes both the question and answer session as well as the event itself. Thank you so much for attending today’s presentation and you may now disconnect your lines.

Peter Niklund, Chairman of the Board, Hansa Biopharma: Thank you. Have a good day everybody.

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