- Agreements on funding obtained in three countries; HTA submissions in ten countries; and Marketing Authorization Applications filed in
Switzerland andIsrael - Growing number of patient candidates identified as leading transplantation centers get clinically ready to transplant this underserved population
- Enrollment in AMR and GBS programs accelerated by initiation of additional centers; On track for completion according to previous guidance
- Dialogue with FDA on regulatory path in anti-GBM expected to be concluded later this year as previously guided
U.S. RCT study - site initiation progressing with first site open for recruitment inSan Antonio, TX
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 inSweden ,the Netherlands andFinland . Health Technology Assessment (HTA) dossiers have been submitted in ten countries, includingUK ,Germany ,Norway andIsrael and most recently inItaly andScotland during the third quarter.Hansa expects to complete HTA filings in all EU5 by year-end, withFrance andSpain 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 andIsrael . European Society for Organ Transplantation (ESOT) Congress inMilan -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. InEurope , constructive regulatory advice meeting held with German health authorities BfArM;Hansa is now preparing for dialogue with theEuropean 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. TheU.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 ofSeptember 2021 . With its existing cash positionHansa 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 toSEK 163m for the first nine months of 2021 (first nine months'20:SEK 177m ). SG&A expenses amounted toSEK 83m in Q3 2021 (Q3'20:SEK 52m ) and toSEK 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 | Q3 2021 | Q3 2020 | 9M 2021 | 9M 2020 |
Revenue | 4.9 | 0.8 | 18.5 | 2.3 |
SG&A expenses | -82.8 | -51.7 | -224.1 | -139.8 |
R&D expenses | -60.6 | -71.3 | -162.5 | -176.8 |
Operating profit/loss | -148.2 | -123.4 | -384.2 | -316.6 |
Net profit/loss | -148.4 | -122.4 | -384.9 | -315.0 |
Cash flow from operating activities | -131.5 | 4.8 | -364.9 | -193.8 |
Cash and short-term investments | 1,006.7 | 1,476.2 | 1,006.7 | 1,476.2 |
Shareholders' equity | 899.6 | 1,338.2 | 899.6 | 1,338.2 |
EPS before and after dilution (SEK) | -3.34 | -2.77 | -8.65 | -7.61 |
Number of outstanding shares | 44,473,452 | 44,473,452 | 44,473,452 | 44,473,452 |
Weighted avg. number of shares before and after dilution | 44,473,452 | 44,135,067 | 44,473,452 | 41,405,758 |
Number of employees at the end of the period | 127 | 80 | 127 | 80 |
Søren Tulstrup, President and CEO of
"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
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
In the
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
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
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
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
The presentation will be held in English and be hosted by
To participate in the telephone conference, please use the dial-in details provided below:
The webcast will be available on https://streams.eventcdn.net/hansa/2021q3
The interim report and latest investor presentation can be downloaded from our web
Interim report January -
https://investors.hansabiopharma.com/English/financial-data/quarterly-report/default.aspx
Investor road show presentation Q3, 2021
https://investors.hansabiopharma.com/English/events-and-presentations/presentations/default.aspx
This is information that
For further information, please contact:
Mobile: +46 (0) 709-298 269
E-mail: klaus.sindahl@hansabiopharma.com
Head of Corporate Communications
Mobile: +46 (0) 768-198 326
E-mail: katja.margell@hansabiopharma.com
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