HANSA MEDICAL AB ORD - HNSBF STOCK NEWS

Hansa Biopharma (Nasdaq Stockholm: HNSA) announced that imlifidase significantly reduced donor-specific antibodies (DSAs) by 94.4% within 5 days of treatment, compared to 35.6% reduction with standard of care, in the 16-HMedIdeS-12 phase 2 trial for patients with antibody mediated rejection (AMR) episodes following a kidney transplant. The trial also showed a 74% six-month graft survival and eGFR of 30mL/min/1.73m2 in the imlifidase arm, with a safety profile consistent with previous clinical trials.

Hansa Biopharma (HNSBF) announced a favorable reimbursement decision in Spain, enhancing access to its product Idefirix^® across major European markets. Total Q1 revenue reached SEK 24.2m, with SEK 14.3m from product sales, a decline from SEK 30.3m in Q1 2022. The company completed enrollment in a phase 2 study of imlifidase for Guillain-Barré Syndrome (GBS) and initiated a phase 1 study of HNSA-5487. Additionally, the pivotal ConfIdeS trial for kidney transplantation is progressing, with 62 out of 64 patients enrolled. The company reported substantial net losses, SEK 205.4m, from operations and cash consumption of SEK 207.0m.

Hansa Biopharma's Idefirix^® has been recommended by the Scottish Medicines Consortium (SMC) for desensitizing highly sensitized kidney transplant patients. This marks a significant milestone, as it is now the first and only product endorsed for this purpose in Scotland. The SMC emphasizes Idefirix^® as clinically and cost-effective, allowing NHS Scotland to fund its use in hospitals. This recommendation follows a positive NICE endorsement in England, expanding patient access across the UK.

Hansa Biopharma announced a $70 million non-dilutive financing agreement with NovaQuest Capital Management, aimed at enhancing its development capabilities for imlifidase in kidney transplantation and other therapeutic areas. This funding extends the company's cash runway through 2024, allowing it to support the ConfIdeS trial and advance a global Phase 3 trial for anti-GBM antibody disease. The financing terms include royalty payments on future sales and milestone payments capped at $140 million.

Hansa Biopharma's Nomination Committee has proposed Peter Nicklin as the new Chairman of the Board, replacing Ulf Wiinberg who has chosen not to stand for re-election. Nicklin brings extensive experience in the life sciences and leadership of global teams. Wiinberg, who served since 2016, credited his decision to resign to his commitments in the United States. The Annual General Meeting is scheduled for June 30, 2022, where this proposal will be presented.

Hansa Biopharma has received early access approval for Idefirix^® (imlifidase) by France's HAS, enabling immediate treatment for highly sensitized kidney transplant patients. The drug targets HLA antibodies to facilitate transplants and is now available at kidney centers across France for one year. Hansa is actively progressing commercial launch efforts in Europe, with completed pricing and reimbursement in Sweden and the Netherlands. Approximately 3,600 kidney transplants are performed annually in France, with 11.1% involving hyperimmune patients awaiting suitable donors.

Hansa Biopharma announced significant advancements in its business update, revealing progress in European commercialization of Idefirix® and a partnership with Medison for expanding access in Central Eastern Europe and Israel. The first patients have enrolled in the pivotal U.S. ConfIdeS study, evaluating imlifidase as a pre-treatment for kidney transplants. As of December 31, 2021, the company reported a cash position of SEK 889 million. Total revenue for 2021 was about SEK 34 million while total operational loss amounted to approximately SEK 547 million.

Hansa Biopharma has entered an agreement with Asklepios BioPharmaceutical to explore the use of imlifidase as a pre-treatment for gene therapy in Pompe disease. Hansa will receive a USD 5 million payment upon execution of the agreement, with AskBio holding an exclusive option for further development based on initial study results. Pompe disease affects 1 in 40,000 births and is caused by a deficiency in the GAA enzyme. This collaboration aims to address challenges posed by neutralizing antibodies against AAV vectors in gene therapies.

Hansa Biopharma will release its interim report for January-June 2021 on July 15, 2021, at 8:00 CET. A conference call detailing the interim results and business update will occur the same day at 14:00 CET. The call will be led by CEO Søren Tulstrup and CFO Donato Spota, available in English. Presentation slides will be accessible on the company's website. Interested parties can join via dial-in numbers for Sweden, the UK, and the U.S. The webcast link will also be provided. Additional events are scheduled through the year, including the William Blair Biotech Focus Conference.