On October 21, 2021 Hansa Biopharma, the pioneer in immunomodulatory enzyme technology for rare IgG mediated diseases, reported its business update and interim report for January – September, 2021 (Press release, Hansa Biopharma, OCT 21, 2021, View Source [SID1234591744]).
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Highlights for the third quarter 2021
Launch and Market Access efforts for Idefirix in Europe are progressing as planned in early launch countries. Reimbursement has been secured in Sweden, the Netherlands and Finland.
Health Technology Assessment (HTA) dossiers have been submitted in ten countries, including UK, Germany, Norway and Israel and most recently in Italy and Scotland during the third quarter. Hansa expects to complete HTA filings in all EU5 by year-end, with France and Spain expected to be submitted in Q4 2021.
Growing number of patient candidates identified as select leading transplantation centers get clinically ready to transplant this underserved population and prioritization programs and policies are adjusted to HLA-incompatible kidney patients, who cannot access an organ through existing allocation systems.
Marketing Authorization Application for Idefirix submitted in Switzerland and Israel.
European Society for Organ Transplantation (ESOT) Congress in Milan – Hansa-sponsored symposium and KOL meetings with very strong interest across entire European transplant community. An ESOT workstream with leading transplantation KOLs has been formed to advance European clinical guidelines for desensitization practices in incompatible kidney transplant patients. Workstream expected to be concluded by year-end.
Patient recruitment in the Phase 2 clinical studies in active antibody mediated rejection (AMR) and Guillain-Barré Syndrome (GBS) has been accelerated by initiation of new centers. In the AMR and GBS trials, 19 and 14 patients, respectively, out of a target of 30 patients in each of the studies have now been enrolled. Completion of enrollment continues to be expected by H2’21/H1’22, with a first data read-out in both studies expected in the second half of 2022, as previously guided.
Anti-Glomerular Basement Membrane (Anti-GBM): In the U.S., dialogue with FDA initiated regarding regulatory path forward, which is expected to conclude later this year as previously guided. In Europe, constructive regulatory advice meeting held with German health authorities BfArM; Hansa is now preparing for dialogue with the European Medicines Agency (EMA).
Partnership with Sarepta and preclinical collaboration with argenx moving forward according to plan.
Hansa Biopharma awarded "Great Place to Work" certification for second consecutive year.
Events after the end of the reporting period
US Randomized Controlled Trial in kidney transplant: First site open for recruitment in San Antonio, Tx. Additional centers are expected to be initiated in the coming months and patient enrollment to start in Q4-2021. The U.S. trial targets 64 patients with the highest unmet medicalneed and is expected to support a BLA submission under the accelerated approval pathway in H1 2024.
Financial summary
Solid cash position of SEK 1,007m at the end of September 2021. With its existing cash position Hansa expects its operations to be financed into 2023.
Investments in R&D in the third quarter amounted to SEK 61m (Q3’20: SEK 71m) and to SEK 163m for the first nine months of 2021 (first nine months’20: SEK 177m). SG&A expenses amounted to SEK 83m in Q3 2021 (Q3’20: SEK 52m) and to SEK 224m for the first nine months of the year 2021 (first nine months’20: SEK 140m), in line with plans.
Cash flow from operating activities for the third quarter ended at SEK -132m (Q3’20: SEK 5m) and
SEK -365m for the first nine months of 2021 (first nine months’20: -194m).
SEKm, unless otherwise stated – unaudited
Søren Tulstrup, President and CEO of Hansa Biopharma, comments
"We continue to make good progress in advancing our clinical, commercial and corporate strategy with solid progress in our efforts to build and advance a pipeline of valuable drug candidates for rare immunologic diseases and launch Idefirix in Europe. We see Idefirix as a potential new transformative therapy that can bring hope to the thousands of highly sensitized patients across the continent who are currently waiting for a compatible kidney transplant. With this novel therapy, we are paving a new path and changing the transplantation ecosystem to accommodate transplants for incompatible kidney patients.
Our goal is to have a positive impact on patients as we work closely with the transplant community to reshape the area of desensitization and integrate Idefirix into clinical practice as a new standard-of-care. We do this in a very focused way – center by center, one patient at a time. We are taking this strategic approach as Idefirix is the first and only approved drug to enable kidney transplants in highly sensitized patients in the EU, who are incompatible with a deceased donor, and the long-term market uptake of this innovative product is highly dependent on successful early experiences in key early adopter centers. Operationally, our Market Access activities in Europe continue according to plan in the early launch countries as evidenced by the recent positive Pricing and Reimbursement decisions by the authorities in the Netherlands and Finland. In addition, we are pleased to have executed agreements with the relevant regions in Sweden on the basis of the June 2021 decision by the national New Therapies Council to recommend Idefirix in highly sensitized patients.
In the U.S., the first site is now open for recruitment in our randomized controlled clinical trial in kidney transplants and we expect the first patient to be enrolled in the fourth quarter. The study initation marks an important milestone for Hansa Biopharma’s efforts to access the U.S. market. The new trial will target 64 highly sensitized patients with a cPRA score of ≥99.9%, representing the group of patients with the highest unmet medical need. We expect to enroll patients at 12-15 leading transplantation centers across the U.S. and that the U.S. trial will generate valuable experience at these key centers.
In our ongoing Phase 2 programs for GBS and AMR, we have initiated additional centers in Q3 to accelerate patient enrollment. We now have 12 centers open for recruitment in AMR and 8 in GBS and expect to open additional centers in the fourth quarter to meet our target of completing enrollment H2’21/H1’22, as previously guided, assuming no further escalation of the COVID-19 pandemic. As of October 21, 2021, 19 out of a target of 30 patients have now been enrolled in the AMR study and 14 out of a target of 30 patients have been enrolled in the GBS study.
Further, we have now initiated dialogue with the FDA on our anti-GBM program. As previously guided, we aim to achieve alignment on the regulatory path forward later this year. I am also pleased to announce a new study in 12 patients in the U.S. to assess whether imlifidase in combination with bortezomib, belatacept, rituximab and IVIg can optimize patient outcomes in highly sensitized patients with donor specific antibodies (DSA) rebound and antibody mediated kidney transplant rejection (AMR). The study will be run at the NYU Langone Transplant Institute and is expected to commence next year.
Regarding our strategic partnerships, our preclinical collaboration with argenx is moving forward according to plan. The preclinical focus of the collaboration aims at understanding potential benefits of combining imlifidase with efgartigimod, argenx’FcRn inhibitor.
Within gene therapy, our partnership with Sarepta to assess imlifidase as a pretreatment to Sarepta’s gene therapy programs in Duchenne and Limb-Girdle Muscular Dystrophy is also progressing according to plan. If positive preclinical data is generated we expect imlifidase to move into the clinic as a next step.
Lastly, I also want to highlight that Hansa Biopharma AB was recently awarded certification as a Great Place to Work for the second consecutive year. The certification as a Great Place to Work reflects our successful efforts over the past years to not only build and maintain a high performance team, but also to create a rewarding and stimulating workplace for our employees.
I look forward to keeping you updated on progress in our mission to leverage our unique IgG-cleaving enzyme technology platform to develop innovative, lifesaving and life-altering immunomodulating therapies, bring these to the patients with rare diseases who need them and generate value to society at large."
Upcoming milestones and news flow
H2 2021 Kidney transplantation US: Enrolment of the first patient
H2 2021 Anti-GBM: Clarity around the regulatory path forward
H2’21/H1’22 AMR Phase 2 study: Complete enrollment
H2’21/H1’22 GBS Phase 2 study: Complete enrollment
2022 NiceR: Completion of GLP tox studies
H2 2022 Kidney transplantation US: Complete enrollment
H2 2022 AMR Phase 2 study: First data read out
H2 2022 GBS Phase 2 study: First data read out
H2 2023 Kidney transplantation US: 12 months follow-up completed
H1 2024 Kidney transplantation US: BLA submission
Conference call details
Hansa Biopharma will host a telephone conference today Thursday October 21 14:00 CET / 8:00am EST.
The presentation will be held in English and be hosted by Hansa Biopharma’s CEO, Søren Tulstrup, and CFO, Donato Spota. Slides used in the presentation will be live on the company website during the call under "Events & Presentation" and will also be made available online after the call.