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Hansa Biopharma
Interim / Quarterly Report • Oct 30, 2025
3057_ir_2025-10-30_3c7620f7-6dde-457f-a786-d9861f4ece23.pdf
Interim / Quarterly Report
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Interim Report
January - September 2025
Imlifidase successfully met primary endpoint in pivotal US Phase 3 ConfldeS trial in kidney transplantation
Business Update
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Year to date IDEFIRIX product sales totaled 143.6 MSEK and represented an increase of 29.1MSEK or 25.4% compared to the same period a year ago (114.5 MSEK). Year to date product sales represents approximately 102% of total full-year product sales achieved in 2024. Product sales in the third quarter of 2025 totaled 30.1 MSEK, compared to 39.8 MSEK for the same period in 2024.
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At Hansa's Extraordinary General Meeting (EGM) on September 2, 2025, Elisabeth Björk, Natalie Berner and Michael Bologna were elected as new Board members. Anders Gersel Pedersen and Florian Reinaud resigned as members of the Board.
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Brian Gorman was appointed as Chief Legal Officer and Corporate Secretary, and Sandra Frithiof appointed as Chief Human Resources Officer. Gorman brings more than 20 years of international legal and governance experience while Frithiof has 25 years of experience in HR leadership across various industries.
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Subsequent Event(s): On October 1, 2025, Hansa successfully completed a directed share issue raising approximately 671.5 MSEK (approximately \$71.3M) before transaction costs with participation from both new and existing shareholders. Proceeds from the share issue will be used for general corporate purposes, including the filing of a Biologic License Application ( "BLA") with the U.S. Food and Drug Administration ( "FDA"), strengthening operational capacity in the U.S. ahead of potential U.S. commercial launch of imlifidase, subject to FDA approval, and a possible supplemental BLA filing for anti-GBM.
Financial Summary
| Amounts in MSEK, unless otherwise stated | Q3 2025 | Q3 2024 | YTD 2025 | YTD 2024 |
|---|---|---|---|---|
| Revenue | 30.8 | 48.7 | 146.3 | 139.0 |
| - thereof: Product sales | 30.1 | 39.8 | 143.6 | 114.5 |
| SG&A expenses | (88.4) | (75.8) | (254.9) | (255.3) |
| R&D expenses | (70.2) | (79.6) | (230.3) | (274.3) |
| Loss from operations | (147.6) | (116.9) | (395.8) | (463.7) |
| Loss for the period | (148.3) | (103.8) | (364.2) | (530.3) |
| Net cash used in operations | (99.2) | (148.8) | (353.3) | (527.1) |
| Cash and short-term investments | 252.1 | 553.5 | 252.1 | 553.5 |
| EPS before and after dilution (SEK) | (1.75) | (1.53) | (4.90) | (8.67) |
| Number of outstanding shares | 84,763,222 | 67,814,241 | 84,763,222 | 67,814,241 |
| Weighted average number of shares before and after dilution | 84,763,222 | 67,814,241 | 74,270,996 | 61,162,934 |
| Number of employees at period end | 133 | 135 | 133 | 135 |
Clinical Pipeline Update
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U.S. ConfldeS trial: Imlifidase successfully achieved its primary endpoint in the U.S. Phase 3 pivotal ConfldeS (20-HMedIdeS-17) study in kidney transplantation. At 12 months, mean eGFR was 51.5 mL/min/1.73m2 in the imlifidase arm compared to 19.3 mL/min/1.73m2 in the control arm demonstrating a statistically significant and clinically meaningful difference of 32.2 mL/min/1.73m2 (p<0.0001). Imlifidase was generally well tolerated with a safety profile consistent with previous clinical trial experience. Hansa expects to file a BLA submission with the FDA before year-end 2025.
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SRP-9001-104 in Duchenne Muscular Dystrophy (DMD): Topline results were reported for three patients with DMD treated with imlifidase prior to administration of Sarepta's ELEVIDYS (delandistrogene moxeparvovec-rokl) in the trial. After a single dose of imlifidase, patients experienced a rapid reduction of IgG antibodies, to levels ≥95% less than baseline. In addition, pre-existing anti-AAV antibodies were reduced below a titre of 1:400, enabling treatment with ELEVIDYS. No new safety signals were observed in the trial. This first clinical data supports imlifidase ability to substantially reduce anti-AAV antibodies to allow administration of gene therapies.
Upcoming Key Catalysts - Q4 2025 & H1 2026
Desensitization Gene Therapy
Phase 2 Interim Data Readout: Global trial in Crigler Najjar with Genethon (GNT-018-IDES)
Autoimmune Disease
Phase 3 Top Line Data Readout: Global anti-GBM trial (GOOD-IDES-02)
Desensitization Kidney Transplant
BLA filing with the FDA, requesting priority review
Successful Phase 3 Readout in Kidney Transplant
Renée Aguiar-Lucander CEO, Hansa Biopharma
A key milestone this quarter was the highly statistically significant outcome of the ConfIdeS trial, where imlifidase met its primary endpoint of eGFR (estimated glomerular filtration rate) at 12 months in kidney transplantation, demonstrating a statistically significant (p < 0.0001) and clinically meaningful benefit for highly sensitized patients. This is the first time that imlifidase has been evaluated in a large, randomized and controlled trial and we are delighted with the results. It clearly underscores the unmet medical need for patients requiring an effective desensitization therapy and provides hope for patients who today face many years on dialysis and limited transplant options. Based on the strong data, we are targeting a Biologics License Application (BLA) submission to the FDA under the accelerated approval pathway before year-end 2025, where we will be requesting Priority Review. We hope to be able to present additional data from the phase 3 trial at the American Transplant Congress (ACT) in June of 2026.
Subject to an approval by the FDA, we plan to commercialise imlifidase in the US. In order to successfully launch in the US, we have assembled an experienced and seasoned senior team to lead this effort, and we will start to build out the infrastructure and resources required over the next several quarters.
In Europe, sales of IDEFIRIX were below expectations during the quarter, which reflects seasonality and the continued challenging situation in Germany, as previously noted in our Q2 report. We now have some further insight into this situation, and we believe that Germany unfortunately will provide limited opportunity for highly sensitized patients over the next several quarters, due to the requirement for new guidelines to be prepared, reviewed and implemented. There is also slow progress on achieving regional reimbursement in Spain, which is having an impact on sales.
Having had the opportunity to review the European commercial operation more in depth over the last 3-4 months, it has become apparent that there are several areas of improvement and investment which we believe will address some the key issues and enhance performance. We plan to implement many of these initiatives during Q4 and look forward to improved visibility and predictability in 2026. These initiatives in combination with the recent clinical results from the ConfIdeS trial have the potential to significantly enhance the growth of the European business, the overall potential of which we believe is substantial.
In the third quarter, we reported the first results from a clinical trial sponsored by Sarepta, demonstrating that imlifidase pre-treatment in patients eligible for gene therapy significantly reduced anti-AAV antibodies to levels consistent with the label, thereby potentially enabling access to gene therapy for patients who would otherwise be ineligible. Additionally, the Genethon-sponsored Phase 2 trial (GNT-018-IDES) in Crigler–Najjar syndrome is ongoing, enrolling patients with pre-existing antibodies against AAV vectors. The study is evaluating the safety and efficacy of Genethon's gene therapy candidate, GNT-0003, following imlifidase pre-treatment. Highly encouraging data from the first treated patient was presented at the European Society of Gene & Cell Therapy (ESGCT) on October 10. In this study it was also observed that imlifidase pretreatment enabled dosing with the gene therapy in a patient who otherwise would have been excluded.
Since joining Hansa, I have led a comprehensive transformation of the company, including a strategic reorganization, the appointment of a new executive leadership team, and the establishment of a renewed vision and mission. These foundational changes have been instrumental in positioning Hansa for long-term growth and value creation. We have successfully addressed the company's capital structure by way of debt restructuring and raising of equity to strengthen our financial position and support the advancement of our strategic priorities. The positive data from the ConfIdeS study provides an exciting launchpad from which we hope to drive significant future value and continue to support activities in both gene therapy and autoimmune diseases.
Looking ahead, we expect to report data from the GOOD-IDES-02 Phase 3 study in anti-GBM disease in Q4 2025. We look forward to sharing the results as we continue to address unmet medical needs and advance our pipeline in rare autoimmune disease.
An Extraordinary General Meeting was held on September 2nd, during which Elisabeth Björk, Natalie Berner, and Michael Bologna were elected to the Board of Directors. We welcome them to the Board and look forward to them sharing their insights and expertise to continue to support the business.
As a subsequent event, on October 1st, we successfully completed a directed share issue, raising approximately SEK 671.5 million (USD 71.5 million) in gross proceeds. The capital raise received strong support from both new and existing shareholders and was multiple times oversubscribed. Proceeds will be used for general corporate purposes, including preparations for a BLA submission to the FDA, expansion of operational capabilities in the U.S. ahead of a potential commercial launch of imlifidase (subject to approval), a possible supplemental BLA filing for anti-GBM disease, and other ongoing operational needs.
We are excited to continue our journey to address unmet medical needs for patients with serious immune mediated conditions and remain focused on creating sustainable value for all our stakeholders.
Imlifidase Commercial and Pipeline Update
Commercial Update
EU: Kidney transplantation in highly sensitized patients
The launch of IDEFIRIX continues to progress across European and international markets. Year-to-date product sales were 25% higher compared to the same period in 2024. Q3 2025 product sales were 24% lower than Q3 2024, due to fewer than expected kidney transplants, and lower orders, largely driven by the pause in the German Eurotransplant Prioritized Program and reimbursement challenges in Catalunya, one of the largest regions in Spain.
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.
IDEFIRIX is now reimbursed in 21 European and international countries, including UK and Switzerland, providing national reimbursement to over 90% of the European population. Efforts remain underway to secure reimbursement in key regions in large European markets, such as Catalunya in Spain where regional reimbursement has not been established.
Pipeline Update
Post Authorization Efficacy and Safety Study (PAES) - 20-HMedIdeS-19
Enrolment for the PAES trial was completed in Q1 2025 with top-line data expected in mid-2026. This study fulfils a key post-approval commitment under the European conditional marketing authorization for IDEFIRIX and is designed to support the transition to full marketing approval. The trial includes participation from 22 transplant centers, underscoring the continued clinical interest in and adoption of IDEFIRIX. Most participating sites have now established treatment protocols and gained direct experience in managing highly sensitized kidney transplant patients. The trial remains on track.
ConfIdeS U.S. Phase 3 Trial - 20-HMedIdeS-17
Imlifidase successfully achieved its primary endpoint in the U.S.US Phase 3 pivotal ConfIdeS trial in kidney transplantation. At 12 months, mean eGFR was 51.5 mL/min/1.73m2 in the imlifidase arm compared to 19.3 mL/min/1.73m2 in the control arm demonstrating a statistically significant and clinically meaningful difference of 32.2 mL/min/1.73m2 (p<0.0001).
The trial was well conducted, with patient retention in excess of 90%. A key secondary endpoint–dialysis independence at 12 months–was also statistically significant in favour of
imlifidase (p=0.0007). Imlifidase was generally well tolerated with a safety profile consistent with previous clinical trial experience. Full results from the Phase 3 ConfIdeS trial will be submitted for presentation at a medical congress in 2026.
Global Phase 3 anti-glomerular basement membrane (anti-GBM) Disease Trial - GOOD-IDES-02
Enrolment for the GOOD-IDES-02 Phase 3 trial has been completed with topline data expected later in Q4 2025. This open-label, controlled, randomized, multi-center study is evaluating renal function outcomes in patients with severe anti-GBM disease treated with imlifidase in combination with SoC versus SoC alone. The trial remains on track.
SRP-9001-104 Phase 1b Trial in Duchenne Muscular Dystrophy (DMD)
Sarepta's Phase 1b trial (SRP-9001-104) is evaluating the use of imlifidase as a pretreatment to Sarepta's gene therapy ELEVIDYS (delandistrogene moxeparvovec), in patients with DMD. Following a safety update for ELEVIDYS in March, several gene therapy trials–including SRP-9001-104–were temporarily halted at the request of EU reference member state authorities.
To date, three patients have been successfully treated with imlifidase. A single dose of imlifidase resulted in a rapid and profound reduction of IgG antibodies to levels below >95% of baseline. Pre-existing anti-AAV antibodies were reduced below the titre threshold of 1:400, enabling subsequent administration of ELEVIDYS. The combination treatment was well tolerated, with a safety profile consistent with prior experience and no new safety signals observed.
Twelve weeks following the gene therapy administration, transduction of the microdystrophin gene was confirmed in all three patients. Expression of micro-dystrophin was observed, although at levels lower than what was seen in other ELEVIDYS studies. Hansa and Sarepta plan to review the data and discuss next steps during Q4.
Genethon Phase 2 Trial in Crigler Najjar - GNT-018-IDES
In December 2024, Genethon and Hansa announced the initiation of GNT-018-IDES, a Phase 2 trial in patients with Crigler-Najjar syndrome who have pre-existing antibodies against adeno-associated virus (AAV) vectors. The study is evaluating the efficacy and safety of a single intravenous dose of Genethon's gene therapy, GNT-0003, following pretreatment with imlifidase in patients with severe Crigler-Najjar syndrome and pre-formed antibodies to AAV serotype 8 (AAV8). Due to protocol adjustments the enrolment will be completed 1H 2026, instead of 2025.
Subsequent Event: The feasibility and efficacy of a pre-treatment with imlifidase, enabling gene therapy in a patient with Crigler–Najjar syndrome and antibodies towards AAV 8 was presented at European Society of Gene & Cell Therapy (ESGCT), October 10th .
| Preclinical | Phase 1 | Phase 2 | Phase 3 | Marketed | Partner | Upcoming Milestone | |
|---|---|---|---|---|---|---|---|
| Desensitization Kid | Iney Transplantation | 2026: EU PAES data read out | |||||
| Desensitization Kio | Iney Transplantation | Q4 2025: BLA submission to FDA based on ConfldeS US Phase 3 data |
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| Desensitization Ge | ne Therapy (Crigler N | lajjar) | GENETHON CORE TRACOUNT REPORTERS | 1H 2026: complete enrolment | |||
| • | Desensitization Gen | e Therapy (DMD) | SAREPTA | Discussions ongoing regarding next steps | |||
| idefirix (imlifidase) | Autoimmune GBS | 1H 2026: data publication | |||||
| Autoimmune anti-0 | BBM | Q4 2025: Phase 3 data read out | |||||
| Autoimmune ANCA | A Investigator Initiated | l Trial (IIT)¹ | Recruitment phase concluded | ||||
| Hansa 5487 | Hansa 5487 | Q4 2025: Indication to be communicated |
Hansa Biopharma is a pioneering commercial-stage biopharmaceutical company on a mission to develop and commercialize innovative, lifesaving and life altering treatments for patients with rare immunological conditions. Hansa has developed a first-in-class immunoglobulin G (IgG) antibody cleaving enzyme therapy that enables desensitization for highly sensitized kidney transplant patients. Our drug discovery and development pipeline is based on the Company's proprietary IgG-cleaving enzyme technology platform. We are focused in four strategic therapeutic areas – transplantation, autoimmune diseases, gene therapy and new therapies – where there are little to no treatment options available. Hansa is based in Lund, Sweden with operations in Europe and the U.S. Find out more at www.hansabiopharma.com.
5 Hansa Biopharma Interim Report Q3 2025
Financial Review 2025: Third Quarter & Year to Date
Revenue
Revenue for the third quarter 2025 totaled 30.8 MSEK (2024: 48.7 MSEK) consisting of IDEFIRIX product sales of 30.1 MSEK (2024: 39.8 MSEK) and contract revenue of 0.7 MSEK (Q3 2024: 8.9 MSEK). The contract revenue in Q3 2025 was primarily related to the Axis-Shield agreement The corresponding contract revenue for the same period in 2024 reflected revenue from the Sarepta agreement and it was fully recognized in 2024.
For the nine months ended September 30, 2025, revenue totaled 146.3 MSEK (2024: 139.0 MSEK) including IDEFIRIX product sales of 143.6 MSEK (2024: 114.5 MSEK) and contract revenue of 2.7 MSEK (2024: 24.5 MSEK). Year to date product revenue increased by 29.1 MSEK or 25.48%.
Sales General & Administrative (SG&A) expenses
SG&A expenses for the third quarter 2025 totaled 88.4 MSEK (2024: 75.8 MSEK) and 254.9 MSEK for the nine-month period ended September 30, 2025 (2024: 255.3 MSEK). The year-over-year third quarter expense increase was 12.6 MSEK or ~16.6% and reflects increased costs associated with the expected U.S. market launch in mid-2026. Despite the third quarter increase in SG&A expenses, year to date expenses were slightly favorable to the same period a year ago.
For the nine-month period 2025, non-cash expenses for the Company's long-term incentive programs (LTIP) were included in SG&A and totaled 13.9 MSEK compared to 18.3 MSEK for the same period in 2024.
Research & Development (R&D) expenses
R&D expenses for the third quarter 2025 totaled 70.2 MSEK (2024: 79.6 MSEK) and 230.3 MSEK for the first nine months of 2025 (2024: 274.3 MSEK). Year-over-year third quarter R&D expenses were 9.4 MSEK or ~11.8% favorable compared to the prior year. For the nine months ended September 30, 2025, R&D expenses were 44.0 MSEK or 16.0% favorable compared to the same period a year ago. This favorable variance was driven by savings associated with the restructuring activities implemented in 2024, offset by continued investments in the U.S. Phase 3 ConfIdeS study, EMA post-approval commitments, the ongoing Phase 3 study in anti-GBM and CMC development expense for HNSA-5487.
Non-cash expenses related to the Company's LTIP program were included in R&D expense and totaled 7.7 MSEK for the first nine months of 2025 compared to 7.9 MSEK during the same period in 2024.
Other operating income/expenses, net and finance income/expenses, net
Other operating income/expenses, net, primarily included gains or losses from foreign exchange rate fluctuations in operations. For the first nine months 2025, the Company recorded an income of 2.1 MSEK, and an expense of 3.1 MSEK in the first nine months of 2024. The change is primarily due to a strengthening in the exchange rate of the Swedish Krona against the primarily US dollar and Euro, affecting deferred revenue as well as accounts payable and receivable positions on the balance sheet.
Financial income/expenses, net, for the third quarter of 2025, totaled 0.0 MSEK (Q3 2024 income of 13.3 MSEK). For the first nine months of 2025, the income totaled 33.5 MSEK compared to an expense of 66.4 MSEK for the first nine months of 2024. The financial expenses, primarily driven by foreign exchange as the Swedish Krona exchange rate compared to the US dollar strengthened. This impacted the interest associated with the NovaQuest loan. The YTD 2025 financial expenses included non-cash interest expense associated with the NovaQuest loan of 98.8 MSEK (9M 2024: 97.7 MSEK), a non-cash loss of 59,4 MSEK (9M 2024: 0.0) from the loan restructuring modification, favourable foreign exchange fluctuations associated with the NovaQuest loan to 157.1 MSEK (9M 2024 unfavorable: 56.2 MSEK), and other items (see Note 3).
Financial results
The loss from operations for the third quarter 2025 totaled 147.6 MSEK (2024: 116.9 MSEK) and 395.8 MSEK for the first nine months of 2025 (2024: 463.7 MSEK). The decrease in Hansa's operating loss for the first nine months of 2025 compared to the same period previous year was driven by lower overall expenses as well as increased sales.
The third quarter loss for the period totaled 148.3 MSEK (Q3 2024: 103.8 MSEK) and for the first nine months of 2025 the loss for the period totaled 364.2 MSEK (9M 2024: 530.3 MSEK).
Cash flow, cash and investments
Net cash used in operating activities for the third quarter 2025 totaled 99.2 MSEK (Q3 2024: 148.8 MSEK) and 353.3 MSEK for the first nine months of 2025 (9M 2024: 527.1 MSEK). The change for the first nine months, compared to the prior year, was driven by lower operating expenses and a positive change in working capital balance sheet accounts. The share issue completed during Q2 increased cash balances by 217.4 MSEK net of transaction costs.
Cash and cash equivalents totaled 252.1 MSEK at September 30, 2025, compared to 405.3 MSEK at December 31, 2024.
Parent Company
The parent company's revenue for the third quarter of 2025 totaled 30.8 MSEK (Q3 2024: 48.7 MSEK) and for the first nine months of 2025 to 146.3 (9M 2025: 139.0 MSEK). The third quarter 2025 the parent company loss for the period totaled 174.3 MSEK (Q3 2024: 134.0 MSEK) and for the first nine months of 2025 the loss for the period was 452.4 MSEK (9M 2024: 619.8 MSEK).
The parent company shareholders' equity at September 30, 2025, totaled 617.7 MSEK compared to 674.4 MSEK at December 31, 2024.
The Group consists of the parent company, Hansa Biopharma AB, and the subsidiaries Cartela R&D AB, Hansa Biopharma Ltd, Hansa Biopharma Inc., Hansa Biopharma Italy S.r.l. and Hansa Biopharma Australia PTY LTD. On September 30, 2025, Hansa Biopharma Inc. had fourteen employees, Hansa Biopharma Ltd nine employees and Hansa Biopharma S.r.l. three employees.
Financial Review 2025: Third Quarter & Year to Date (continued)
Long-term incentive programs
At Hansa Biopharma's previous Annual General Meetings, shareholders resolved to adopt various share-based LTIP programs. As of September 30, 2025, the Company incurred non-cash equity-based compensation expense under the following LTIP programs: 2020, 2021, 2022, 2023, 2024 and 2025.
The respective non-cash costs related to the ongoing LTIP programs are summarized in the table below. In the 2025 LTIP program, a number of Hansa employees invested their own capital to purchase warrants. For further information on the different LTIP programs, please refer to Hansa Biopharma's 2024 Annual Report which can be found at www.hansabiopharma.com.
| LTIP 2020 |
LTIP 2021 |
LTIP 2022 |
LTIP 2023 |
LTIP 2024 |
LTIP 2025 |
|---|---|---|---|---|---|
| 633,776 | 71,500 | 58,500 | 625,658 | 1,179,404 | 7,472,356 |
| 487,520 | 55,000 | 45,000 | 486,893 | 917,824 | 4,501,250 |
| 1,688,250 | |||||
| 25,863 | 15,473 | 8,047 | 14,068 | 30,025 | 60,985 |
| 0 | (14) | 3,024 | 3,118 | 7,072 | 8,442 |
| 21,642 | |||||
| Total costs, including social contributions, as of September 30, 2025 YTD, KSEK |
Risks and uncertainties
Hansa's business is subject to a variety of external and internal factors that may significantly affect the Company's financial performance and position - many of which are partially or entirely beyond the Company's control. When evaluating the Company's prospects, it is important to consider these risks, alongside the potential for earnings growth in order to form a balanced and realistic assessment of the Company's expected development.
Since the fourth quarter 2022, Hansa has capitalized development costs related to IDEFIRIX following the conditional approval granted by the EMA (see Note 4). In 2023, based on conditional approval, the parent company also revalued the underlying intangible asset related to IDEFIRIX. Both the decision to begin development costs and the revaluation of the intangible assets in the parent company were based on the assessment that Hansa is likely to obtain final EMA approval for the commercialization of IDEFIRIX. As part of the conditional approval, the EMA has required Hansa to conduct two clinical trials to support final approval:
- a) A five-year follow-up study of 46 patients previously treated with IDEFIRIX in a Phase II trial was performed. This follow-up clinical study was finalized and submitted to EMA in December 2023. In 2024, EMA finalized its review and the study was approved.
- b) A post-authorization efficacy and safety (PAES) study, involving 50 kidney transplant patients treated with IDEFIRIX with a reference group of 50 transplant patients receiving standard-of-care treatment without IDEFIRIX was completed in Q1 2025. Following the completion of the study, patients will be monitored for one year to assess the long-term effect of the drug. The objective of the follow up study is to determine whether outcomes in highly sensitized patients treated with IDEFIRIX are comparable to those receiving standard treatment. Hansa currently has no indication that the study would be unsuccessful.
Given that the follow-up study has been approved and there are no indications that the PAES study will be unsuccessful, Hansa considers the risk of not meeting EMA's conditions for final approval to be low.
Risk factors include, among others, uncertainties regarding clinical trials and regulatory approvals, collaborations and partnerships, intellectual property rights, reliance on key products, market dynamics and competition, manufacturing and supply chain challenges, pricing and reimbursement, as well as dependence on key persons and financial risks.
On October 1, 2025, Hansa completed a directed share issue raising gross proceeds of approximately 671.5 MSEK (approximately 71.3 MUSD) with participation from both new and existing shareholders. On a pro forma basis, with the completion of this capital raise and existing cash and cash equivalents at September 30, 2025 (252.1 MSEK) the Company has approximately 923.6 MSEK of cash. A detailed overview of the key risks and uncertainties facing Hansa can be found in the English version of the Company's 2024 Annual Report (pages 32-35).
On a regular basis, Hansa's Board of Directors and senior management review the development of these risks and uncertainties. No material changes from the presentation in the 2024 Annual Report have been identified as of the date of this quarterly report.
Financial Review 2025: Third Quarter & Year to Date (continued)
Other information
Contacts
Evan Ballantyne, Chief Financial Officer Hansa Biopharma
E-mail: [email protected]
Legal Disclaimer
This financial report includes statements that are forward-looking, and actual future results may differ materially from those stated. In addition to the factors discussed, among other factors that may affect results are developments within research programs. This is a translated version of the Swedish original.
Financial Calendar 2026
February 12, 2026 Full Year 2025 Report March 26, 2026 Annual and Sustainability Report for 2025 April 23, 2026 Interim Report for January – March 2026
Shareholder information
Brief facts
| Listing | Nasdaq OMX Stockholm |
|---|---|
| Number of shares September 30, 2025 | 84,763,222 |
| Market Cap September 30, 2025 | ~2.22 BSEK (USD ~\$233M) |
| Ticker | HNSA |
| ISIN | SE0002148817 |
Top 10 Shareholders as of September 30, 2025
| Shareholder Name | Number of Shares | Ownership % |
|---|---|---|
| Redmile Group LLC | 16,309,214 | 19.24% |
| NovaQuest Capital Management LLC | 6,398,981 | 7.55% |
| Braidwell LP | 4,128,105 | 4.87% |
| Theodor Jeansson Jr. | 3,520,000 | 4.15% |
| Avanza Pension | 3,112,198 | 3.67% |
| Fourth Swedish National Pension Fund (AP4) | 2,569,000 | 3.03% |
| Hansa Biopharma AB | 2,037,291 | 2.40% |
| Handelsbanken Fonder | 1,957,631 | 2.31% |
| Thomas Olausson | 1,917,000 | 2.26% |
| Nexttobe AB | 1,355,379 | 1.60% |
| All other | 41,458,799 | 45.99% |
| Total Shares Outstanding | 84,763,222 | 100.00% |
Source: Modular Finance compiled and processed data from various sources, including Euroclear, Morningstar, FactSet and the Swedish Financial Supervisory Authority (Finansinspektionen).
Hansa Biopharma had approximately 20,000 shareholders as of September 30, 2025.
The Board of Directors and the Chief Executive Officer affirm that the consolidated financial statements have been prepared in accordance with International Financial Reporting Standards (IFRS) as adopted by the EU and give a fair view of the group's financial position and results. The interim report has been prepared in accordance with generally accepted accounting principles for the group and the parent company and gives a fair overview of the development of the group's and the parent company's operations, financial positions, and results.
Lund, Sweden, October 30, 2025
Peter Nicklin Chairman of the Board
Hilary Malone Eva Nilsagård Board member Board member
Mats Blom Elisabeth Björk Board member Board member
Michael Bologna Jonas Wikström Board member Board member
Natalie Berner Board member
This report has been reviewed by the company's auditors.
Hansa Biopharma is a pioneering commercial-stage biopharmaceutical company on a mission to develop and commercialize innovative, lifesaving and life altering treatments for patients with rare immunological conditions. Hansa has developed a first-in-class immunoglobulin G (IgG) antibody cleaving enzyme therapy that enables desensitization for highly sensitized kidney transplant patients. Our drug discovery and development pipeline is based on the Company's proprietary IgG-cleaving enzyme technology platform. We are focused in four strategic therapeutic areas – transplantation, autoimmune diseases, gene therapy and new therapies – where there are little to no treatment options available. Hansa is based in Lund, Sweden with operations in Europe and the U.S. Find out more at www.hansabiopharma.com.
9 Hansa Biopharma Interim Report Q3 2025
Unaudited Condensed Financial Statements
Unaudited condensed consolidated statement of financial position
| September 30 | |||||
|---|---|---|---|---|---|
| KSEK | Note | 2025 | 2024 | 2024 | |
| ASSETS | |||||
| Non-current assets | |||||
| Intangible assets | 4 | 265,440 | 174,844 | 197,333 | |
| Property and equipment | 3,377 | 5,117 | 4,682 | ||
| Right-of-use assets | 8,152 | 15,058 | 13,198 | ||
| Total non-current assets | 276,969 | 195,019 | 215,213 | ||
| Current assets | |||||
| Inventories | 3,529 | 1,976 | 2,610 | ||
| Trade receivables & unbilled revenues | 165,793 | 144,645 | 144,965 | ||
| Current receivables, non-interest bearing | 42,742 | 45,491 | 32,574 | ||
| Cash and cash equivalents | 252,072 | 553,544 | 405,280 | ||
| Total current assets | 464,136 | 745,656 | 585,429 | ||
| TOTAL ASSETS | 741,105 | 940,675 | 800,642 | ||
| EQUITY AND LIABILITIES | |||||
| Shareholders' equity | (560,744) | (319,959) | (589,833) | ||
| Non-current liabilities | |||||
| Long-term loan | 3 | 774,695 | 942,950 | 1,064,645 | |
| Deferred tax liabilities | 122 | 174 | 168 | ||
| Provisions | 6,923 | 4,701 | 4,259 | ||
| Lease liabilities | 971 | 8,624 | 6,678 | ||
| Refund liabilities | 99,459 | - | 59,038 | ||
| Total non-current liabilities | 882,170 | 956,449 | 1,134,788 | ||
| Current liabilities | |||||
| Short-term loan Tax liabilities |
140,078 1,951 |
- 1,121 |
- 2,705 |
||
| Lease liabilities | 8,151 | 7,614 | 7,684 | ||
| Current liabilities, non-interest bearing | 63,604 | 51,617 | 55,491 | ||
| Deferred revenue | 13,986 | 20,552 | 16,334 | ||
| Refund liabilities | 65,152 | 132,499 | 64,484 | ||
| Accrued expenses | 126,757 | 90,782 | 108,989 | ||
| Total current liabilities | 419,679 | 304,185 | 255,687 | ||
| TOTAL EQUITY AND LIABILITIES | 741,105 | 940,675 | 800,642 | ||
Unaudited condensed consolidated statement of profit or loss and other comprehensive income (loss)
| Q3 | 9M | |||||
|---|---|---|---|---|---|---|
| KSEK | Note | 2025 | 2024 | 2025 | 2024 | |
| Revenue | 2 | 30,804 | 48,664 | 146,275 | 138,979 | |
| Cost of revenue | (20,108) | (11,380) | (58,904) | (70,066) | ||
| Sales, general and administration expenses | (88,413) | (75,819) | (254,927) | (255,276) | ||
| Research and development expenses | 4 | (70,206) | (79,624) | (230,306) | (274,267) | |
| Other operating income/(expenses), net | 311 | 1,231 | 2,066 | (3,074) | ||
| Loss from operations | (147,612) | (116,928) | (395,796) | (463,704) | ||
| Financial income | 10,279 | 5,784 | 145,938 | 16,990 | ||
| Financial expenses | 3 | (10,230) | 7,474 | (53,036) | (83,403) | |
| Non-cash loss on loan restructuring | - | - | (59,447) | - | ||
| Loss before tax | (147,563) | (103,670) | (362,341) | (530,117) | ||
| Tax | (693) | (126) | (1,872) | (201) | ||
| Loss for the period | (148,256) | (103,796) | (364,213) | (530,318) | ||
| Loss for the period attributable to owners of the parent | (148,256) | (103,796) | (364,213) | (530,318) | ||
| Loss per share, basic and diluted (SEK) | (1.75) | (1.53) | (4.90) | (8.67) | ||
| Other comprehensive income/(loss) | ||||||
| Items that have been, or may be reclassified to profit | ||||||
| or loss for the period: | ||||||
| Translation differences | (288) | (565) | (2,467) | 167 | ||
| Other comprehensive income/(loss) for the period | (288) | (565) | (2,467) | 167 | ||
| Total comprehensive loss | (148,544) | (104,361) | (366,680) | (530.151) |
Unaudited condensed consolidated statement of changes in shareholders' equity
| January-September | ||||
|---|---|---|---|---|
| KSEK | 2025 | 2024 | 2024 | |
| Opening balance of shareholders' equity | (589,833) | (167,876) | (167,876) | |
| Result for the period | (364,213) | (530,318) | (807,243) | |
| Translation reserve | (2,467) | 167 | 1,350 | |
| Net comprehensive loss | (366,680) | (530,151) | (805,893) | |
| Transactions with the group's owner | ||||
| Proceeds from new share issuance, net1 | 217,397 | 354,308 | 354,308 | |
| Proceeds from restructuring of debt | 141,472 | - | - | |
| Long term incentive programs | 18,515 | 23,760 | 29,629 | |
| Long term incentive program option contribution2 | 18,385 | - | - | |
| Total transactions with the group's owner | 395,769 | 378,068 | 383,937 | |
| Closing balance of shareholders' equity | (560,744) | (319,959) | (589,833) |
1 Total share issue cost 2025 amounted to SEK 14.703 KSEK, total share issue cost 2024 amounted to 17,845 KSEK.
Unaudited condensed consolidated statement of cash flow
| 2024 KSEK 2025 2024 2025 Cash Flows from Operating Activities (530,318) Loss for the period (148,254) (103,796) (364,211) 74,347 Adjustment for non-cash items 1 (21,410) 32,657 (24,393) 758 Interest received and paid, net (101) (134) (69) (900) Income taxes paid (800) (617) (2,455) Cash flow from operations before change in working (116,498) (125,957) (391,128) (456,113) capital (70,971) Changes in working capital 17,291 (22,844) 37,877 (527,084) Net cash used in operating activities (99,207) (148,801) (353,251) Investing activities (116) Acquisition of property and equipment - - - (116) Cash flow from investing activities - - - Financing activities Proceeds from new share issue, net of transaction cost2 - - 217,397 354,308 Restructuring costs long-term loan - - (9,530) - (5,627) Payment of lease liabilities (1,892) (1,978) (5,869) 348,681 Cash flow from financing activities (1,978) (1,892) 201,998 (178,519) Net change in cash (101,185) (150,693) (151,253) 732,060 Cash and cash equivalents at beginning of period 353,321 704,999 405,280 Currency exchange variance, cash and cash (64) (762) (1,955) 3 equivalents Cash and cash equivalents, end of period 252,072 553,544 252,072 553,544 |
Q3 | 9M | |||
|---|---|---|---|---|---|
1 Values are mainly costs of share-based incentive programs including social contributions and depreciation, partly offset by certain capitalized development costs (see further in Note 4).
2 In the 2025 LTIP program, a number of Hansa employees invested their own capital to purchase warrants.
Total share issue cost 2025 amounted to SEK 14,703 KSEK. Total share issue cost 2024 amounted to SEK 17,845 KSEK.
Parent Company – Unaudited condensed statement of financial position
| September 30 | December 31 | |||
|---|---|---|---|---|
| KSEK | Note | 2025 | 2024 | 2024 |
| ASSETS | ||||
| Non-current assets | ||||
| Intangible assets | 4 | 1,425,732 | 1,453,976 | 1,446,684 |
| Property and equipment | 3,377 | 5,117 | 4,682 | |
| Right-of-use assets | 8,152 | 15,058 | 13,198 | |
| Investment in subsidiaries | 38,891 | 34,593 | 34,194 | |
| Total non-current assets | 1,476,152 | 1,508,744 | 1,498,758 | |
| Current assets | ||||
| Inventories | 3,529 | 1,976 | 2,610 | |
| Trade receivables & unbilled revenues | 165,793 | 144,645 | 144,965 | |
| Current receivables, non-interest bearing | 41,440 | 45,203 | 31,160 | |
| Cash and cash equivalents | 243,392 | 534,273 | 385,103 | |
| Total current assets | 454,154 | 726,097 | 563,838 | |
| TOTAL ASSETS | 1,930,306 | 2,234,841 | 2,062,596 | |
| EQUITY AND LIABILITIES | ||||
| Shareholders' equity | 617,721 | 975,218 | 674,449 | |
| Non-current liabilities | ||||
| Long-term loan | 3 | 774,695 | 942,950 | 1,064,645 |
| Provisions | 6,923 | 4,701 | 4,259 | |
| Lease liabilities | 971 | 8,624 | 6,678 | |
| Refund liabilities | 99,459 | - | 59,038 | |
| Total non-current liabilities | 882,048 | 956,275 | 1,134,620 | |
| Current liabilities | ||||
| Short-term part of loan | 140,078 | - | - | |
| Tax liabilities | 485 | 1,187 | 1,119 | |
| Lease liabilities | 8,151 | 7,614 | 7,684 | |
| Liabilities, group companies | 20,800 | 8,614 | 11,480 | |
| Current liabilities, non-interest bearing | 63,676 | 51,133 | 55,448 | |
| Deferred revenue | 13,986 | 20,552 | 16,334 | |
| Refund liabilities | 65,152 | 132,499 | 64,484 | |
| Accrued expenses | 118,209 | 81,749 | 96,978 | |
| Total current liabilities | 430,537 | 303,348 | 253,527 | |
| TOTAL EQUITY AND LIABILITIES | 1,930,306 | 2,234,841 | 2,062,596 |
Parent Company – Unaudited condensed statement of profit or loss and other comprehensive income (loss)
| Q3 | 9M | ||||
|---|---|---|---|---|---|
| KSEK | Note | 2025 | 2024 | 2025 | 2024 |
| Revenue | 2 | 30,804 | 48,664 | 146,275 | 138,979 |
| Cost of revenue | (49,900) | (41,172) | (148,279) | (159,441) | |
| Sales, general and administration expenses | (88,277) | (76,032) | (259,265) | (253,217) | |
| Research and development expenses | 4 | (67,106) | (79,439) | (225,490) | (276,242) |
| Other operating income/(expenses), net | (70) | 910 | 1,244 | (3,237) | |
| Loss from operations | (174,549) | (147,069) | (485,515) | (553,158) | |
| Financial income | 10,279 | 5,785 | 145,938 | 16,981 | |
| Financial expenses | 3 | (10,229) | 7,462 | (53,022) | (83,404) |
| Non-cash loss on loan restructuring | - | - | (59,447) | - | |
| Loss before tax | (174,499) | (133,822) | (452,046) | (619,581) | |
| Income tax | 235 | (137) | (326) | (224) | |
| Loss for the period | (174,264) | (133,959) | (452,372) | (619,805) | |
| Other comprehensive loss for the period | - | - | - | - | |
| Total comprehensive loss for the period | (174,264) | (133,959) | (452,372) | (619,805) |
Parent Company – Unaudited condensed statement of changes in shareholders' equity
| Q3 | Full year | ||
|---|---|---|---|
| KSEK | 2025 | 2024 | 2024 |
| Opening balance of shareholders' equity | 674,449 | 1,216,945 | 1,216,945 |
| Result for the period | (452,372) | (619,805) | (926,376) |
| Other comprehensive income/(loss) for the period | - | - | - |
| Net comprehensive loss | (452,372) | (619,805) | (926,376) |
| Proceeds from new share issuance, net1 | 217,397 | 354,308 | 354,308 |
| Proceeds from restructuring of debt | 141,472 | - | - |
| Long term incentive programs | 18,390 | 23,770 | 29,572 |
| Long term incentive program option contribution2 | 18,385 | - | - |
| Total other transactions | 395,644 | 378,078 | 383,880 |
| Closing balance of shareholders' equity | 617,721 | 975,218 | 674,449 |
Total share issue cost 2025 amounted to SEK 14,703 KSEK. Total share issue cost 2024 amounted to SEK 17,845 KSEK.
In the 2025 LTIP program, a number of Hansa employees invested their own capital to purchase warrants.
Financial Notes
Note 1 Basis of preparation and accounting policies
This consolidated interim report has been prepared in accordance with IAS 34 Interim Financial Reporting and applicable rules in the Swedish Annual Accounts Act. The interim report for the parent Company has been prepared in accordance with the Swedish Annual Accounts Act chapter 9, Interim Financial Reporting, and recommendation RFR2 of the Swedish Reporting Board, Accounting for Legal entities. The same accounting principles have been used as in the latest annual report except for what is stated below. Hansa's Annual Report for 2024 was published on March 21, 2025, and is available at www.hansabiopharma.com. Disclosures in accordance with IAS 34.16A are as applicable in the notes or on the pages before the consolidated income statement.
Note 2 Revenue
| Income per significant category of income | Q3 | 9M | ||
|---|---|---|---|---|
| KSEK | 2025 | 2024 | 2025 | 2024 |
| Group | ||||
| Revenue | ||||
| Product sales | 30,133 | 39,811 | 143,583 | 114,478 |
| Contract revenue, Axis-Shield agreement | 671 | 651 | 2,015 | 1,953 |
| Cost reimbursement, Axis-Shield agreement | - | - | 677 | 581 |
| Contract revenue, Sarepta, AskBio agreement | - | 8,202 | - | 21,967 |
| 30,804 | 48,664 | 146,275 | 138,979 | |
| Parent Company | ||||
| Revenue | ||||
| Product sales | 30,133 | 39,811 | 143,583 | 114,478 |
| Contract revenue, Axis-Shield agreement | 671 | 651 | 2,015 | 1,953 |
| Cost reimbursement, Axis-Shield agreement | - | - | 677 | 581 |
| Contract revenue, Sarepta, AskBio agreement | - | 8,202 | - | 21,967 |
| 30,804 | 48,664 | 146,275 | 138,979 |
Note 3 Long-term loan
On July 18, 2022, the Company entered into a US \$70.0 million funding agreement with NovaQuest. The funding was accounted for as a liability and classified as debt because the Company has an unavoidable obligation to settle the agreement in cash. The debt will be accounted for over the life of the agreement.
The net proceeds from the funding agreement totaled US \$69.2 million after the deduction of transaction costs.
In June 2025, Hansa and NovaQuest entered into agreements to restructure their existing debt agreement. As part of the restructuring, and in connection with the Directed Share Issue, Hansa offset approximately US \$14.875 million of its outstanding debt through the issuance of new shares at the same price as in the Directed Share Issue (the "First Tranche"). The First Tranche was resolved by the Company's Board of Directors under the authorization granted at the Annual General Meeting held on June 27, 2024, and with deviation from the shareholders' preferential rights.
On January 31, 2026, Hansa shall also pay NovaQuest US \$14.875 million (Second Tranche), either in ordinary shares or in cash, at the Company's discretion. If paid in shares, the subscription price will be the lower of (i) the subscription price in the Directed Share Issue or (ii) the volume-weighted average price (VWAP) of the Company's ordinary shares on Nasdaq Stockholm during the ten trading days immediately preceding the day before the resolution of the share issue.
NovaQuest has agreed to a lock-up for each share issue, restricting the sale or disposition of shares for a period of 180 calendar days from the respective issue date, subject to customary exceptions and the Company's prior written consent.
The remaining debt will be paid in three fixed cash payments scheduled for June 2027, June 2028 and January 2029. In addition, previously agreed approval-related payments will be eliminated. Under the restructured terms, total payments from Hansa to NovaQuest will be capped at US \$150.5 million an increase from the original agreement cap of US \$140.0 million. The NovaQuest debt restructuring actions were deemed to be non-substantive.
An updated version of the original security agreement entered into under the initial debt agreement remains in place under which the Company has granted NovaQuest a broad security interest in certain assets, proceeds and intellectual property rights related to imlifidase for use in kidney transplantation in highly sensitized patients and in the treatment of anti-GBM disease.
The new debt amendment resulted in modification of the original debt agreement. As a result, the debt was remeasured based on the net present value of the revised cash flows, discounted using a fair value effective interest rate. This remeasured amount was compared to the previous carrying value of the original debt, with any difference recognized as a gain or loss in the financial statements. Transaction costs incurred in connection with the new amendment were also recognized as part of a gain or loss calculation on the modification.
The Company records the difference between the principal and the total payments as interest expense over the term of the debt by applying the effective-interest-rate method. Based on the progress of the payments, the Company will recalculate the effective interest each reporting period until the debt obligation has been satisfied.
On September 30, 2025, the loan totaled 914.8 MSEK, including 391.3 MSEK in total accrued interest.
Note 4 Intangible assets – Internally-generated intangible assets
Expenditures related to research activities are recognized as expense in the period in which it is incurred. An internally‑generated intangible asset arising from development (or from the development phase of an internal project) is recognized only if all the following criteria have been demonstrated in accordance with IAS 38:
- the technical feasibility of completing the intangible asset so that it will be available for use or sale;
- the intention to complete the intangible asset and use or sell it;
Financial Notes continued
- the ability to use or sell the intangible asset;
- how the intangible asset will generate probable future economic benefits;
- the availability of adequate technical, financial and other resources to complete the development and to use or sell the intangible asset; and
- the ability to measure reliably the expenditure attributable to the intangible asset during its development.
The amount initially recognized for internally‑generated intangible assets is the sum of the expenditures incurred from the date when the intangible asset first meets all the recognition criteria listed above. Development expenses, for which no internally‑generated intangible asset can be identified, are expensed in the statement of profit and loss and other comprehensive income in the period in which they are incurred.
The Company determined that IDEFIRIX and its conditional approval by EMA to enable kidney transplantation in highly sensitized patients met all the above criteria as of Q4 2022.
As of September 30, 2025, the total capitalized development expenses related to fulfilling the IDEFIRIX EMA post-approval commitments amount to 290.1 MSEK, with 90.4 MSEK capitalized during 2025. These capitalized development costs are subject to regular amortization over their useful life, which is projected to extend until the end of 2032. Total accumulated amortization at September 30, 2025 was 42.8 MSEK.
Glossary
Adeno-associated virus (AAV)
AAV is a versatile viral vector technology that can be engineered for very specific functionality in gene therapy applications.
Allogeneic hematopoietic stem cell transplantation (HSCT)
Allogeneic HSCT, also known as "bone-marrow" transplantation, involves transferring the stem cells from a healthy person (the donor) to the patient's body after highintensity chemotherapy or radiation. The donated stem cells can come from either a related or an unrelated donor.
AMR
Antibody mediated transplant rejection.
Antibody
One type of protein produced by the body's immune system with the ability to recognize foreign substances, bacteria or viruses. Antibodies are also called immunoglobulins. The human immune system uses different classes of antibodies so called isotypes known as IgA, IgD, IgE, IgG, and IgM.
Anti-GBM disease (Goodpasture syndrome)
Anti-GBM antibody disease is a disorder in which circulating antibodies directed against an antigen intrinsic to the glomerular basement membrane (GBM) in the kidney, thereby resulting in acute or rapidly progressive glomerulonephritis.
Autoimmune disease
Diseases that occur when the body's immune system reacts against the body's own structures.
Biologics License Application (BLA)
A Biologics License Application (BLA) is submitted to the Food and Drug Administration (FDA) to obtain permission for distribution of a biologic product across the United States.
CD20
B-lymphocyte antigen CD20 is a protein expressed on the surface of B-cells. Its function is to enable optimal B-cell immune response.
Clinical studies
Investigation of a new drug or treatment using healthy subjects or patients with the intention to study the efficacy and safety of a not-yet-approved treatment approach.
Clinical phase 1
The first time a drug under development is administered to humans. Phase I studies are often conducted with a small number of healthy volunteers to assess the safety and dosing of a not yet approved form of treatment.
Clinical phase 2
Refers to the first time a drug under development is administered to patients for the study of safety, dosage and efficacy of a not yet approved treatment regimen.
Clinical phase 3
Trials that involve many patients and often continue for a longer time; they are intended to identify the drug's effects and side effects during ordinary but still carefully controlled conditions.
DSA
Donor specific antibodies. Donor specific antibodies are antibodies in a transplant patient which bind to HLA and/or non-HLA molecules on the endothelium of a transplanted organ, or a potential donor organ. The presence of pre-formed and de novo (newly formed) DSA, specific to donor/recipient mismatches are major risk factors for antibody-mediated rejection.
EMA
The European Medicines Agency (EMA) is an EU agency for the evaluation of medicinal products.
Enzyme
A protein that accelerates or starts a chemical reaction without itself being consumed.
ESOT
The European Society for Organ Transplantation (ESOT) is an umbrella organisation which overlooks how transplantations are structured and streamlined.
FDA or US FDA
U.S. Food and Drug Administration.
Guillain-Barré syndrome
Guillain-Barré syndrome (GBS), is an acute autoimmune disease in which the peripheral nervous system is attacked by the immune system and IgG antibodies.
HBP
Heparin Binding Protein is a naturally occurring protein that is produced by certain immune cells, i.e. neutrophilic granulocytes, to direct immune cells from the bloodstream into the tissues.
HLA
Human Leukocyte Antigen is a protein complex found on the surface of all cells in a human. The immune system uses HLA to distinguish between endogenous and foreign.
IgG
IgG, Immunoglobulin G, is the predominant type of antibody in serum.
Imlifidase
Imlifidase, is the immunoglobulin G-degrading enzyme of Streptococcus pyogenes, a bacterial enzyme with strict specificity for IgG antibodies. The enzyme has a unique ability to cleave and thereby inactivate human IgG antibodies while leaving other Ig-isotypes intact.
IND
Investigational New Drug (IND) application is required to get approval from the FDA to administer an investigational drug or biological product to humans.
INN
International Nonproprietary Name (INN) is a generic and non-proprietary name to facilitate the identification of a pharmaceutical substances or active pharmaceutical ingredient.
In vitro
Term within biomedical science to indicate that experiments or observations are made, for example in test tubes, i.e. in an artificial environment and not in a living organism.
In vivo
Term within biomedical science to indicate that experiments or observations are made in living organisms.
IVD
IVD, In vitro diagnostics, are tests that can detect diseases, conditions, or infections, usually from blood samples or urine samples. Some tests are used in laboratory or other health professional settings and other tests are for consumers to use at home.
Marketing Authorization Application (MAA)
A Marketing Authorization Application (MAA) is an application submitted to the European Medicines Agency (EMA) to market a medicinal product in the EU member states.
Neutralizing Antibodies (NAbs)
NAb is an antibody that defends a cell from a pathogen or infectious particle by neutralizing any effect it has biologically.
Pivotal trial
A clinical trial intended to provide efficacy and safety data for NDA approval at e.g. FDA or EMA. In some cases, Phase 2 studies can be used as pivotal studies if the drug is intended to treat life threatening or severely debilitating conditions.
Panel Reactive Antibody (PRA)
PRA is an immunological laboratory test routinely performed on the blood of people awaiting organ transplantation. The PRA score is expressed as a percentage between 0% and 99%. It represents the proportion of the population to which the person being tested will react via pre-existing antibodies.
Preclinical development
Testing and documentation of a pharmaceutical candidate's properties (e.g. safety and feasibility) before initiation of clinical trials.
Randomized Control Trial (RCT)
RCT is a study design where the trial subject is randomly allocated to one of two or more study cohorts to test a specific intervention against other alternatives, such as placebo or standard of care.
Streptococcus pyogenes
A Gram-positive bacterium that primarily can be found in the human upper respiratory tract. Some strains can cause throat or skin infections.
Standard of Care (SOC)
Treatment that is accepted by medical experts as a proper treatment for a certain type of disease and that is widely used by healthcare professionals.