Hansa Biopharma Year-end record January-December 2022 

• Complete 2022 earnings of SEK 155m
• Cash money path expanded right into 2025
• Market Gain access to gotten in 4 of the 5 biggest European markets
• Reported favorable Stage 2 top-line information in AMR
• Choice made to launch professional research study with imlifidase as a pre-treatment to Sarepta’s SRP-9001 genetics treatment in 2023

LUND, Sweden, Feb. 2, 2023/ PRNewswire/– Hansa Biopharma, the leader in immunomodulatory enzyme innovation for uncommon IgG mediated conditions, today revealed its company upgrade and also Year-end record for January to December 2022

Emphasizes for the 4th quarter 2022

• Complete Q4 earnings of SEK 31m consisting of SEK 20m in item sales and also SEK 11m, generally under the arrangements with Sarepta and also AskBio.
• Favorable repayment choices gotten in Italy and also Czech Republic for Idefirix ^{®(* )in very animated kidney transplant clients. Market accessibility currently safeguarded in 11 European nations consisting of 4 of the 5 biggest European markets.} Hansa and also companion Sarepta Therapy revealed strategies to launch a medical research study with imlifidase as a pre-treatment to Sarepta’s SRP-9001 genetics treatment in DMD throughout 2023.
• Favorable topline information from the imlifidase stage 2 research study in antibody moderated denial (AMR) message kidney hair transplant revealed, revealing analytical supremacy over plasma exchange.
• Increased
• SEK 416m (USD ~ 40m) in a guided share concern broadening money path right into 2025. Scientific pipe upgrade

UNITED STATE TRUSTS: Since

• February 1, 2023, 51 clients, out of a target of 64 clients, have actually been registered in our crucial united state open tag, randomized, managed test of imlifidase in kidney hair transplant. Hansa intends to finish registration in the initial fifty percent 2023, while conclusion of randomization is anticipated in the 2nd fifty percent 2023 targeting a Biologics Certificate Application (BLA) entry under the increased authorization path in 2024, as formerly led. AMR: Topline information from the imlifidase stage 2 research study in antibody moderated denial (AMR) message kidney hair transplant shows a statistically dramatically remarkable ability of imlifidase to swiftly decrease degrees of donor-specific antibodies (DSAs) contrasted to plasma exchange (criterion of treatment) in the 5 days adhering to the begin of therapy. Hansa intends to release the complete dataset in the 2nd fifty percent of 2023.
• Anti-GBM: Hansa’s crucial stage 3 research study in anti-Glomerular Cellar Membrane layer (anti-GBM) condition began
• mid-December 2022 with the initial websites triggered. GBS: Since
• February 1, 2023, 25 clients, out of a target of 30 clients in the Guillain Barré Disorder (GBS) Stage 2 test, have actually been registered and also Hansa anticipates to finish registration in the initial fifty percent of 2023, as formerly led, with the initial high degree information read-out anticipated H2 2023. NiceR program (lead prospect HNSA-5487) advancing, with Investigational New Medicine (IND) allowing toxicology research studies finished and also Scientific Test Application (CTA) authorized to launch professional research study in the initial fifty percent of 2023.
• Genetics Treatment: Complying with effective pre-clinical job finished by Hansa and also Sarepta, strategies were revealed to launch a medical research study with imlifidase as a pre-treatment to Sarepta’s SRP-9001 genetics treatment in Duchenne Muscle Dystrophy (DMD) throughout 2023.
• Occasions after the closing duration

On

• January 30, 2023, it was revealed that Christian Kjellman, Principal Scientific Police Officer (CSO) and also Principal Operating Police Officer (COO), has actually made a decision to leave the firm in 2024. Reliable promptly, Commercial Procedures will certainly report straight to Head of state and also Chief Executive Officer Søren Tulstrup and also a search is underway for a brand-new CSO. Monetary recap

SEKm, unless or else mentioned – unaudited

2022 was an effective year at Hansa with strong efficiency and also solid progression throughout the company. I delight in with the forward energy we remain to make throughout R&D, Commercial and also Procedures. In

Europe, we are really happy to have actually safeguarded Market Gain access to in 11 nations consisting of 4 of the 5 biggest markets. In August, the initial clinical standards for desensitization therapy of very animated kidney transplant clients were released. These standards are the initial to consist of Idefirix

®(* )and also stand for the initial global agreement on a monitoring path for kidney transplant clients with high unmet requirement. This highlights the essential function that Idefirix ^® can play as a brand-new, transformative treatment to make it possible for kidney hair transplant and also is an essential action in guaranteeing its usage as a prospective brand-new Gold Requirement in desensitization procedures. ^{On the growth side, we remained to drive progression throughout our pipe. In November, we offered topline information from our Stage 2 program in AMR, message hair transplant, showing dramatically remarkable ability of imlifidase to swiftly decrease DSA degrees in contrast to plasma exchange in the 5 days adhering to the begin of the therapy.} In 2022 we launched 2 brand-new Stage 3 research studies, specifically the European Blog post Authorization Effectiveness Research study in kidney hair transplant and also the crucial, international Stage 3 research study in anti-GBM condition. Both research studies will certainly target 50 clients and also include a considerable variety of facilities as we widen our experience with imlifidase to come to be a prospective brand-new criterion of treatment in both hair transplant and also intense autoimmune conditions.

Client enrolment remains to advance in the ConfIdeS test – our crucial, stage 3 test in kidney hair transplant in the United States – with 51 out of a target of 64 clients registered. In the GBS Stage 2 program, 25 out of a target of 30 clients have actually been registered. We intend to include even more facilities to enhance ability and also speed up registration in both tests. Registration conclusion for both tests is anticipated in the initial fifty percent 2023, while conclusion of randomization in the United States trusts test is anticipated in the 2nd fifty percent 2023. We are targeting entry of a Biologics Certificate Application (BLA), under the increased authorization path, in 2024, as formerly led.

I am additionally really happy with the success made in the preclinical growth programs, particularly, in the DMD program with Sarepta in genetics treatment and also in the NiceR program, which is discovering application of second-generation enzymes for repeat application. In DMD, imlifidase is being explored as a prospective pre-treatment in clients with pre-existing IgG antibodies to Sarepta’s SRP-9001. To day, the information looks appealing, and also strategies have actually been revealed to launch a medical research study in 2023. We finished IND allowing toxicology research studies at the end of in 2015 in the NiceR program for the lead prospect HNSA 5487. A CTA authorization has actually because been gotten and also we anticipate to begin a medical test in the initial fifty percent 2023.

A vital column in our general approach is to advance pick cooperations. I delight in to share that we revealed our 2nd partnership in genetics treatment with AskBio, in Pompe condition. At the same time, we remain to get a constant circulation of passion from various other genetics treatment business, wanting to work together with us, utilizing our antibody cleaving enzyme innovation system.

We delight in to have actually safeguarded funding – offering us path right into 2025– via 2 funding occasions in 2022. In July, we increased

USD 70m

via a non-dilutive funding deal with NovaQuest and also in December, increased USD 40m in a guided share concern targeting united state and also various other global medical care expert capitalists. With each other these purchases will certainly aid fund prep work for a prospective united state launch of imlifidase in kidney hair transplant, enhance recurring item growth tasks and also increase the Business’s R&D pipe. We expect an interesting year in advance, with a number of essential landmarks throughout our system and also treatment locations, as we proceed the growth of brand-new, transformative medications for clients dealing with major, uncommon immunologic conditions.” Future landmarks and also information circulation

H1 2023 GBS Stage 2: Full registration

H1 2023 Anti-GBM Stage 3: First client registered

H1 2023 united state Kidney hair transplant (ConfIdeS): Full registration

H1 2023 HNSA 5487 (Lead NiceR prospect): Start Stage 1 research study

2023 Sarepta DMD pre-treatment: Commence professional research study

H2 2023 Lasting follow-up research study in kidney hair transplant: 5-year information readout

H2 2023 AMR Stage 2: Complete information readout

H2 2023 GBS Stage 2: First information readout

H2 2023 united state Kidney hair transplant (ConfIdeS): Full randomization

2024 united state Kidney hair transplant (ConfIdeS): BLA entry

Upgraded monetary schedule 2023

March 30

, 2023 2022 Yearly Record

April 20, 2023 Meantime Record for January-

March 2023 June 14, 2023 2023 Yearly General Satisfying

July 20, 2023 Half-year Record for January-

June 2023 October 18, 2023 Meantime Record for January-

September 2023 Teleconference information Hansa Biopharma will certainly organize a telephone meeting today

Thursday February 2 2023

, 14:00 CET/ 8:00 am EST The discussion will certainly be kept in English and also be organized by Hansa Biopharma’s chief executive officer, Søren Tulstrup, and also CFO, Donato Spota

Slides utilized in the discussion will certainly be survive the firm internet site throughout the telephone call under “Occasions & & Discussion” and also will certainly additionally be offered online after the telephone call. To join the telephone meeting, please make use of the dial-in information given listed below: Sweden

: +46 10 884 80 16

UK: +44 020 3936 2999

USA: +1 646 664 1960

Individual accessibility code: 031372 The webcast will certainly be readily available on https://events.q4inc.com/attendee/195504216

The Year-end record and also most current financier discussion can be downloaded and install from our internet

Year-end record January to

December 2022

https://www.hansabiopharma.com/investors/financial-reports/ Capitalist roadway reveal discussion Q4, 2022 https://www.hansabiopharma.com/investors/presentations/ This is info that Hansa Biopharma abdominal muscle is required to reveal according to the Stocks Markets Act.(* )For more info, please call:

Klaus Sindahl

,

VP Head of Capitalist Relations

M: +46 (0) 709– 298 269 E: Stephanie Kenney,
VP Worldwide Business Matters
M: +1 (484) 319 2802[email protected]

E: The adhering to data are readily available for download:
Resource Hansa Biopharma Abdominal