Idefirix® recommended by
Highlights for the second quarter 2021
- Commercial launch activities for Idefirix® in
Europe are progressing as planned in early launch countries, such as the Nordics, Benelux,U.K. andGermany .Hansa continues to prioritize its Market Access efforts through close interactions with national reimbursement authorities and leading transplant clinics. -
In late
June 2021 , theSwedish New Therapies Council recommended the use of Idefirix® as desensitization treatment for highly sensitized kidney transplant patients. The recommendation provided by theNew Therapies Council inSweden represents the first national level decision by an EU member state. Hansa hosted an Idefirix® launch symposium onJune 30, 2021 with attendance from more than 120 transplant physicians representing around 80 transplant centers from 13 European countries.-
Following
U.S. FDA interactions, theU.S. trial design for a randomized, controlled trial of imlifidase in highly sensitized kidney transplant patients was announced in lateJune 2021 . The new study will target 64 patients with the highest unmet medical need in theU.S. , with the first patient expected to be included in H2 2021 as previously guided. -
Patient recruitment in the phase 2 clinical studies in active antibody mediated rejection (AMR) and Guillain-Barré Syndrome (GBS) continues under a risk-based, site-by-site approach due to the COVID-19 pandemic. In the AMR and GBS trials, 12 and 10 patients, respectively, out of a target of 30 patients in each of the studies have now been enrolled. The persistent presence of the COVID-19 pandemic in
Europe , most recently the emergence of the Delta variant causing new waves in several European countries where important trial centers are located, negatively impacts enrollment rates. As remedial action, efforts are underway to initiate recruitment in new centers. While the increase in number of active trial centers is expected to also increase the enrollment rate in H2 2021 despite the continued impact of COVID-19, the volatility of the situation leadsHansa to expand its guidance for completion of enrollment to also include the first half of 2022. First data read-out in both studies is expected in the second half of 2022, as previously guided. -
IND-enabling toxicology studies for the NiceR program were initiated in the second quarter as planned. GLP toxicology studies are expected to be completed in 2022. Upon successful completion of these studies,
Hansa expects to advance the NiceR program into clinical studies. -
Annual General Meeting held on
May 12, 2021 , all resolutions were approved by shareholders, including the appointment ofHilary Malone , Ph.D. to the Board of Directors.Dr. Malone is currently COO and EVP atValo Health, Inc. (U.S. ) and has previously held global executive positions atSanofi ,Reata Pharmaceuticals ,Pfizer , Wyeth andAstraZeneca , among others. -
Handelsbanken Fonder reported ownership above 5% on
April 6 2021 .
Financial summary
- Solid cash position of
SEK 1,139m at the end ofJune 2021 .Hansa expects its operations to be financed into 2023. -
Investments in R&D in the second quarter amounted to
SEK 55m (Q2'20:SEK 53m ) and toSEK 102m for the first half-year (H1'20:SEK 106m ). SG&A expenses amounted toSEK81m in Q2 2021 (Q2'20:SEK 49m ) and toSEK 141m for the first half-year (H1'20:SEK 88m ), in line with plans. -
Cash flow from operating activities for the second quarter ended at
SEK -113m (Q2'20:SEK -77m ) andSEK -233m for the first half of 2021 (H1'20: -199m).
SEKm, unless otherwise stated - unaudited | Q2 2021 | Q2 2020 | H1 2021 | H1 2020 |
Revenue | 4.5 | 0.6 | 13.5 | 1.5 |
Gross profit | 2.2 | 0.5 | 9.5 | 1.0 |
SG&A expenses | -81.2 | -49.4 | -141.3 | -88.0 |
R&D expenses | -54.5 | -53.0 | -101.9 | -105.5 |
Operating profit/loss | -132.4 | -101.8 | -236.0 | -193.2 |
Net profit/loss | -132.6 | -99.2 | -236.5 | -192.6 |
Cash flow from operating activities | -112.5 | -77.4 | -233.4 | -198.6 |
Cash and short-term investments | 1,139.4 | 400.2 | 1,139.4 | 400.2 |
Shareholders' equity | 1,031.2 | 378.1 | 1,031.2 | 378.1 |
EPS before and after dilution (SEK) | -2.98 | -2.48 | -5.32 | -4.81 |
Number of outstanding shares | 44,473,452 | 40,026,107 | 44,473,452 | 40.026.107 |
Weighted avg. number of shares before and after dilution | 44,473,452 | 40,026,107 | 44,473,452 | 40.026.107 |
Number of employees | 113 | 78 | 113 | 78 |
Søren Tulstrup, President and CEO of
"
In
We are very pleased with this decision, which is an important step for transplant clinics across
In the
We are pleased to move forward with this study that we believe could support a BLA in the
In our ongoing phase 2 programs for GBS and AMR, we see patient enrollment progressing again following a temporary halt in the recruitment process during large parts of 2020 due to the COVID-19 pandemic. At the end of 2020, patient enrollment was reinitiated in both studies under a risk-based, site-by-site approach.
As of
We are also pleased to have now initiated IND enabling toxicology studies with the lead candidate from our next generation of antibody cleaving enzymes, also known as "NiceR". NiceR is a new set of enzymes developed for repeat dosing scenarios that may potentially open up a broad array of new indications to pursue, including reoccuring AMR, relapsing autoimmune diseases and oncology.
Lastly, I also want to highlight how we continue to build a high-performance organization while adding new competences. At the end of June,
I look forward to keeping you updated on the progress of
Upcoming milestones and news flow
H2 2021 Kidney transplantation US: First patient dosed
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/interim-report-for-january-june-2021/
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 Q2, 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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