** Encouraging high-level results for first-in-human trial of HNSA-5487
** Well attended
**
Highlights for the third quarter of 2023
- Total Q3 revenue of
SEK 22.8m includingSEK 16.5m in product sales andSEK 5.7m under our agreement with Sarepta -
Several new agreements secured with leading transplantation centers in key markets such as
U.K. andGermany . Ongoing patient identification through organ allocation systems such as Eurotransplant, which should translate into increased commercial sales in Q4 2023, as previously guided. European Society of Organ Transplantation (ESOT) Congress inAthens : Held well-attendedHansa -sponsored symposium "Crossing DSA Barriers to Transplant Today" focusing on patient experiences with Idefirix.- First patients treated with imlifidase in an investigator-initiated Phase 2 study in ANCA-associated vasculitis.
Dr. Hitto Kaufmann appointed Chief Scientific Officer (CSO) ofHansa Biopharma responsible for all research, early development, translational and manufacturing activities.Great Place to Work ® certification received for the fourth consecutive year. The 2023 certification is based on a company-wide survey completed with 100% participation fromHansa employees.
Clinical pipeline update
- Anti-GBM disease: Positive momentum in the pivotal phase 3 study in anti-GBM disease, five patients were enrolled during Q3, while number of active sites expanded from 12 to 25 in the past quarter. A total of 9 patients out of a target of 50 patients have been enrolled across centers in the
U.S. ,U.K. and EU. U.S. ConfIdeS trial: As ofOctober 26, 2023 , 87 patients have been enrolled at 16 centers in this pivotalU.S. open label, randomized, controlled trial of imlifidase in kidney transplant. Despite an acceleration in the number of patients being randomized this summer following the initiation of more centers, the allocation of organs to patients on the study remain highly variable and difficult to predict. Randomization is expected to complete by mid 2024 with, a BLA submission expected in 2025.-
ANCA-associated vasculitis: An investigator-initiated single center, single arm study was launched in the first half 2023 by Charité Universitätsmedizin in
Berlin . The study is targeting 10 patients with pulmonary haemorrhage due to severe ANCA-associated vasculitis. As ofOctober 26 , three patients have been treated with imlifidase.
Events after closing period
- On
October 9, 2023 ,Hansa announced first high-level results from the first-in-human trial for HNSA-5487. Data showed the molecule was safe and well tolerated with fast and complete depletion of immunoglobulin G (IgG) antibodies observed in all subjects with increasing doses. -
On
October 17, 2023 ,Hansa announced results from the 5-year long-term study demonstrating 90% patient survival and 82% graft survival. The 5-year extended pooled analysis is a continuation of the analysis at 3-years of crossmatch positive only patients published in theAmerican Journal of Transplantation .
Financial summary
SEKm, unless otherwise stated - unaudited | Q3 2023 | Q3 2022 | 9M 2023 | 9M 2022 |
Revenue | 22.8 | 67.1 | 83.7 | 123.8 |
SG&A expenses | (111.7) | (83.5) | (344.5) | (254.2) |
R&D expenses | (95.6) | (90.4) | (303.1) | (254.0) |
Loss from operation | (202.2) | (139.5) | (613.0) | (442.3) |
Loss for the period | (250.7) | (154.0) | (707.3) | (462.5) |
Net cash used in operation | (193.8) | (128.7) | (582.7) | (392.6) |
Cash and short-term investments | 908.2 | 1,215.3 | 908.2 | 1,215.3 |
Shareholders' equity | (62.2) | 344.8 | (62.2) | 344.8 |
EPS before and after dilution (SEK) | (4,78) | (3.45) | (13.49) | (10.39) |
Number of outstanding shares | 52,443,962 | 44,588,118 | 52,443,962 | 44,588,118 |
Weighted avg. number of shares before and after dilution | 52,443,962 | 44,588,118 | 52,443,962 | 44,517,974 |
Number of employees at the end of the period | 168 | 145 | 168 | 145 |
Søren Tulstrup, President and CEO of
"Our commitment to creating paradigm shifts in clinical care resulting in significantly better patient outcomes remains strong. Ongoing progress with the commercialisation of Idefirix continues, and our pipeline of drug candidates, underpinned by exciting science, is progressing steadily.
We continue to see steady growth in the number of key transplant centers readied for utilisation of Idefirix and patients identified and waitlisted for desensitization across
During the third quarter we have secured several new agreements with leading transplant centers in
On
I am also pleased to see positive data from our 5-year long follow-up study further supporting the clinical benefit of imlidase in kidney transplantation. Data five years out demonstrate graft survival of 82%, which is in line with outcomes seen at 3-years post-transplant.
In the
In anti-GBM disease, we have recently seen good uptake in patient enrolment in the global pivotal phase 3 study, with nine patients enrolled out of a target of 50 patients, while our newly started investigator-initiated phase 2 study in ANCA-associated vasculitis now has three patients enrolled out of a target of ten patients.
We are also very pleased to report encouraging high-level data from the first-in-human trial for HNSA-5487, the lead candidate from our NiceR program focused on developing next generation IgG-cleaving enzymes. Results demonstrated the molecule was safe and well tolerated with fast and complete depletion of immunoglobulin G (IgG) antibodies observed at increasing doses in all subjects. These data are highly encouraging as we continue to explore the potential for our next generation enzymes and better understand how this powerful new enzyme could benefit patients with diseases where a prolonged IgG-free window is needed and where repeat dosing would be beneficial.
Further, I am happy to welcome
Last, I want to highlight that
I look forward to keeping you updated on our continued progress, with several upcoming important milestones to be achieved across our platform and franchises in the coming period, as we continue our efforts to develop new, transformative medicines for patients suffering from serious, rare immunologic diseases."
Upcoming milestones and news flow
Q4 2023 GBS Phase 2: First data readout
Q4 2023 AMR Phase 2: Full data readout
Q4 2023 Sarepta DMD pre-treatment Phase 1b: Commence clinical study
2024 GBS Phase 2: Outcome of the comparative efficacy analysis to IGOS data
2024 Genethon Crigler-Najjar Phase 1/2: Initiate clinical study with imlifidase prior to GNT-0003
2024 HNSA-5487 (Lead NiceR candidate): Further analysis around endpoints to be completed in 2024 incl. lead indication
2024
2025
Updated financial calendar 2023/2024
Conference call details
The event will be hosted by
Slides used in the presentation will be live on the company website during the call under "Events & Presentations" and will also be made available online after the call.
To participate in the telephone conference, please use the dial-in details provided below:
Participant access code: 765135
The webcast will be available on https://hansabiopharma.eventcdn.net/events/q3-2023-conference-call
The interim report and latest investor presentation can be downloaded from our web:
Interim report January to
Investor road show presentation Q3, 2023 https://www.hansabiopharma.com/investors/presentations/
This is information that
For further information, please contact:
M: +46 (0) 709-298 269
E: klaus.sindahl@hansabiopharma.com
M: +1 (484) 319 2802
E: stephanie.kenney@hansabiopharma.com
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