Strong sales performance and solid momentum with the Phase 3 trial in anti-GBM disease
Cash runway extended into 2026
Evan Ballantyne joins Hansa Biopharma as Chief Financial Officer
LUND, Sweden, April 18, 2024 /PRNewswire/ -- Hansa Biopharma, the pioneer in immunomodulatory enzyme technology for rare IgG mediated diseases, today announced its business update and year-end report for January to March 2024.
Highlights for the first quarter of 2024
Strong commercial performance. Total Q1 revenue of SEK 56m including product sales of SEK 47m - sales growth during Q1 2024 was driven by product sales in our largest European markets including France, UK, and Germany, as well as initial sales in Belgium. Represents first time Company has delivered two consecutive quarters of strong growth.
IDEFIRIX has achieved pricing and reimbursement in 75% of the European kidney transplant market; Ongoing HTA processes in 11 countries including, most recently, in Ireland.
Evan Ballantyne joined Hansa Biopharma as Chief Financial Officer effective March 1, 2024. Previously served as CFO of Gain Therapeutics, Inc., a U.S. based biotech company. Evan brings to Hansa more than 30 years of international experience as a senior financial executive in both public and private life science companies.
Clinical pipeline update
US ConfIdeS trial (kidney transplantation): 122 patients have been enrolled with 49 of 64 targeted patients randomized in this pivotal, Phase 3 U.S. open label, randomized, controlled trial of imlifidase in kidney transplantation.
Post Approval Study (kidney transplantation): 36 patients have been treated (72% completion). The study will support full marketing authorization in Europe and is expected to be completed by 2025.
Phase 3 (anti-GBM disease): 25 of 50 targeted patients enrolled in global pivotal Phase 3 trial in anti-glomerular basement membrane (anti-GBM) disease. Completion of enrollment is expected in 2025.
Cash runway extended into 2026: Raised SEK ~372m (USD ~34.6m) in a directed share issue targeting mainly high-quality international healthcare specialist investors.
Financial summary
SEKm, unless otherwise stated - unaudited
Q1 2024
Q1 2023
FY 2023
Revenue
56.0
24.2
134.1
- thereof: Product sales
47.4
14.3
103.7
SG&A expenses
(91.3)
(103.3)
(450.5)
R&D expenses
(103.0)
(92.8)
(411.3)
Loss from operation
(159.4)
(182.3)
(788.5)
Loss for the period
(218.6)
(205.4)
(831.7)
Net cash used in operations
(189.1)
(207.0)
(755.7)
Cash and short-term investments
541.5
1,286.8
732.1
EPS before and after dilution (SEK)
(4.15)
(3.92)
(15.83)
Number of outstanding shares
52,671,796
52,443,962
52,671,796
Weighted avg. no of shares before and after dilution
52,671,796
52,443,962
52,540,089
No of employees at the end of the period
166
159
168
S?ren Tulstrup, President and CEO of Hansa Biopharma, comments:
"I am very pleased with the strong commercial performance in the first quarter of 2024, the second consecutive quarter with solid product sales and a promising start to 2024. This strong sales performance is a continuation of the traction we saw at the end of last year where key large markets such as UK and Germany started to contribute. Our performance continues to be driven by our largest markets underpinned by new and repeat use of IDEFIRIX at leading transplant centers. We have now achieved pricing and reimbursement in 75% of the European kidney transplant market and expect to see utilization in new centers resulting in additional sales growth in 2024.
Our clinical programs in kidney transplantation continue to progress at pace. Enrolment and randomization in our pivotal US Phase 3 trial (ConfIdeS) is advancing as expected. During the first quarter of 2024 four new sites have been activated and both screening and randomization of eligible patients have recently accelerated. We expect randomization to complete in mid-2024, as previously guided.
We have also made significant progress in the European post approval study - PAES - with more than a doubling of the number of patients treated in the trial in the last couple of quarters. This post approval study is an obligation under the European conditional marketing authorization and will be used to further investigate the long-term graft survival in 50 highly sensitized kidney transplant patients treated with IDEFIRIX. The study will also help generate important clinical experience in leading transplant centers in using IDEFIRIX as a new transformative desensitization therapy in highly sensitized patients.
Beyond kidney transplantation, we continue to advance our imlifidase clinical programs in autoimmunity. In the Phase 3 trial in anti-GBM disease, our lead autoimmune indication, we have reached 50% enrolment in the trial and expect completion in 2025 as previously guided. We also expect to share contextualized efficacy data later this year in our 15-HMedIdeS-09 Phase 2 study in Guillain-Barré Syndrome (GBS). This follows promising first high-level data shared in December 2023.
On April 12, 2024, we announced that additional financing had been secured - extending our cash runway into 2026 through a SEK ~372m (USD ~34.6m) directed share issue targeting mainly U.S. and European healthcare specialist investors. I am very pleased to see the strong interest in the Hansa equity story from leading international health specialist investors. This transaction will help finance the preparation of a potential U.S. launch of imlifidase in kidney transplantation, strengthen ongoing product development in autoimmune indications and allow for the continued clinical development of HNSA-5487, the lead candidate from the NiceR program for repeat dosing.
Lastly, I am delighted to welcome Evan Ballantyne as Chief Financial Officer. With his deep international experience and successful track record as a CFO at public and private life science companies I am confident that Evan will be a strong addition to our team and will help drive our financial strategy, deliver on key strategic priorities, and build shareholder value.
We look forward to keeping you updated on our continued progress, with several upcoming important milestones to be achieved across our platform and franchises as we continue the development of new, transformative medicines for patients suffering from serious, rare immunologic diseases."
Upcoming milestones and news flow
2024 GBS Phase 2: Outcome of the comparative efficacy analysis 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 in FIH trial incl. lead indication 2024 U.S. ConfIdeS (Kidney transplantation) Phase 3: Complete randomization 2024 First high level data read-out from phase 1b study in DMD with Sarepta 2025 U.S. ConfIdeS (Kidney transplantation) Phase 3: BLA submission 2025 Anti-GBM disease Phase 3: Completion of enrollment
Updated financial calendar 2024
Apr 18, 2024 Interim Report for January - March 2024 June 27, 2024 2024 Annual General Meeting in Lund, Sweden July 18, 2024 Half-year Report January - June 2024 Oct 24, 2024 Interim Report for January - September 2024
Conference call details
Hansa Biopharma will host a telephone conference today Thursday, April 18, 2024, 14:00 CET / 8:00am EST.
The event will be hosted by S?ren Tulstrup, President and CEO, Matthew Shaulis, CCO and US President, Evan Ballantyne, CFO, and Hitto Kaufmann, CSO. The presentation will be held in English.
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. Link to presentation
To participate in the telephone conference, please use the dial-in details provided below: Sweden: +46 812 410 952 United Kingdom: +44 203 769 6819 United States: +1 646 787 0157 Participant access code: 765135
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 hansabiopharma.com.
