Hansa Biopharma interim report Jan-June 2021

Idefirix^® recommended by Swedish New Therapies Council for use in highly sensitized kidney patients in Sweden. U.S. trial design announced; first patient expected to be dosed H2 2021

Lund, Sweden July 15, 2021 Hansa Biopharma, the pioneer in immunomodulatory enzyme technology for rare IgG mediated diseases, today announced its business update and interim report for January – June, 2021.

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. and Germany. Hansa continues to prioritize its Market Access efforts through close interactions with national reimbursement authorities and leading transplant clinics.
• In late June 2021, the Swedish New Therapies Council recommended the use of Idefirix^® as desensitization treatment for highly sensitized kidney transplant patients. The recommendation provided by the New Therapies Council in Sweden represents the first national level decision by an EU member state.
• Hansa hosted an Idefirix^® launch symposium on June 30, 2021 with attendance from more than 120 transplant physicians representing around 80 transplant centers from 13 European countries.
• Following U.S. FDA interactions, the U.S. trial design for a randomized, controlled trial of imlifidase in highly sensitized kidney transplant patients was announced in late June 2021. The new study will target 64 patients with the highest unmet medical need in the U.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 leads Hansa 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 of Hilary Malone, Ph.D. to the Board of Directors. Dr. Malone is currently COO and EVP at Valo Health, Inc. (U.S.) and has previously held global executive positions at Sanofi, Reata Pharmaceuticals, Pfizer, Wyeth and AstraZeneca, among others.
• Handelsbanken Fonder reported ownership above 5% on April 6 2021.

Financial summary

• Solid cash position of SEK 1,139m at the end of June 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 to SEK 102m for the first half-year (H1’20: SEK 106m).  SG&A expenses amounted to SEK81m in Q2 2021 (Q2’20: SEK 49m) and to SEK 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) and SEK -233m for the first half of 2021 (H1’20: -199m).

Søren Tulstrup, President and CEO of Hansa Biopharma, comments

“Hansa Biopharma’s transformation into a fully integrated, commercial-stage biopharmaceutical company has become a reality in 2021, and we continue to deliver on our strategic priorities to build tomorrow’s Hansa Biopharma by ensuring the successful commercialization of Idefirix^® in the first markets, advancing our platform in new indications and therapeutic areas, building our organizational capabilities and expanding our technology platform.

In Europe, we continue to roll out our commercial launch activities in the early launch countries as planned and are pleased with the progress we have made so far. As part of this effort, Hansa hosted a very productive Idefirix^® launch symposium on June 30, 2021 with attendance from more than 120 transplant physicians representing 80 transplant centers from 13 European countries. The symposium focused on Idefirix^® as the potential new standard of care for highly sensitized kidney transplant patients needing desensitization treatment and included multiple sessions where expert speakers discussed specific patient cases to address topics around patient selection, AMR management and patient care.

Hansa also continues to maintain close interactions with national reimbursement authorities and leading transplant clinics. A first national level market access decision was announced on June 28, 2021 by Sweden’s New Therapies Council, who recommends use of Idefirix^® as a desensitization treatment for highly sensitized kidney transplant patients in Sweden.

We are very pleased with this decision, which is an important step for transplant clinics across Sweden who would like to introduce Idefirix^® as a desensitization treatment to enable highly sensitized patients to qualify for potentially lifesaving and life-altering kidney transplant from a deceased donor. The recommendation follows an earlier health-economic assessment by the Swedish Dental and Pharmaceutical Benefits Agency (TLV), which concluded that Idefirix® treatment would be cost effective or even cost saving for the society. Moving forward, we expect additional decisions and agreements around reimbursement, funding and market access to be reached in other early launch countries beginning in the second half of 2021 and onwards.

In the U.S., Hansa announced the study design for a randomized, controlled trial of imlifidase in highly sensitized kidney transplant patients. In the study, 64 highly sensitized kidney patients with a cPRA score of ≥99.9% will be enrolled, representing a subset of very highly sensitized patients that continue to be disadvantaged despite prioritization under the U.S. Kidney Allocation System.

We are pleased to move forward with this study that we believe could support a BLA in the U.S. under the accelerated approval pathway in the first half of 2024. Preparatory work has been initiated and we expect to engage with 12-15 leading U.S. transplantation centers to conduct the study. Among the new centers are Northwestern Memorial Hospital in Chicago and University of Alabama (UAB) Hospital in Birmingham. Robert A. Montgomery, M.D. Professor of Surgery and Director, NYU Langone Transplant Institute, New York City has been appointed t Principal Investigatorand we expect study initiation over the summer with the first patient enrolled in the second half of 2021.

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 July 15, 2021, 12 out of a target of 30 patients have now been enrolled in the AMR study, while 10 out of a target of 30 patients have been enrolled in the GBS study. To increase the rate of enrollment of patients in both studies, we plan to open additional centers this summer, reaching a total of 14 centers in the AMR study and 10 centers in the GBS trial compared to the 7 centers currently enrolling in each of the two studies. The persistent presence of the COVID-19 pandemic in Europe, most recently the emergence of the Delta variant, which has caused new waves in several European countries where important trial centers are located, continues to negatively impact enrollment rates. Given the volatility of the situation, we expand our guidance for completion of enrollment to also include the first half of 2022.

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, Hansa had 113 employees, which represents close to a threefold increase in less than 3 years. Our international team is a diverse, talented and highly experienced group of professionals driven by a passion to make a difference for patients with rare immunologicdiseases.

I look forward to keeping you updated on the progress of Hansa Biopharma’s journey as we take the next steps towards building a global leader in rare diseases across multiple broad therapeutic areas through the development of new, transformative medicines for patients suffering from rare immunologic diseases.”

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

Hansa Biopharma will host a telephone conference today Thursday July 15 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.

To participate in the telephone conference, please use the dial-in details provided below:

Sweden: +46 850 558 368

United Kingdom: +44 333 300 92 72

United States: +1 646 722 49 57

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 – June 2021

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 Hansa Biopharma AB is obliged to make public pursuant to the Securities Markets Act.

For further information, please contact:
Klaus Sindahl, Head of Investor Relations
Hansa Biopharma 
Mobile: +46 (0) 709-298 269
E-mail: klaus.sindahl@hansabiopharma.com 

Katja Margell
Head of Corporate Communications 
Hansa Biopharma 
Mobile: +46 (0) 768-198 326
E-mail: katja.margell@hansabiopharma.com

About Hansa Biopharma
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, which has been shown to enable kidney transplantation in highly sensitized patients. Hansa has a rich and expanding research and development program, based on the Company’s proprietary IgG-cleaving enzyme technology platform, to address serious unmet medical needs in transplantation, autoimmune diseases, gene therapy and cancer. Hansa Biopharma is based in Lund, Sweden and has operations in Europe and the U.S. The Company is listed on Nasdaq Stockholm under the ticker HNSA. Find out more at www.hansabiopharma.com.