road show presentation jan sep 2019 forward looking
play

Road Show Presentation Jan-Sep 2019 Forward-looking statement - PowerPoint PPT Presentation

Road Show Presentation Jan-Sep 2019 Forward-looking statement This presentation may contain certain forward-looking statements and forecasts based on our current expectations and beliefs regarding future events and are subject to significant


  1. Road Show Presentation Jan-Sep 2019

  2. Forward-looking statement This presentation may contain certain forward-looking statements and forecasts based on our current expectations and beliefs regarding future events and are subject to significant uncertainties and risks since they relate to events and depend on circumstances that will occur in the future. Some of these forward-looking statements, by their nature, could have an impact on Hansa Biopharma’s business, financial condition and results of operations [or that of its parent, affiliate, or subsidiary companies]. Terms such as “anticipates”, “assumes”, “believes”, “can”, “could”, “estimates”, “expects”, “forecasts”, “intends”, “may”, “might”, “plans”, “should”, “projects”, “will”, “would” or, in each case, their negative, or other variations or comparable terminology are used to identify forward-looking statements. There are a number of factors that could cause actual results and developments to differ materially from those projected, whether expressly or impliedly, in a forward-looking statement or affect the extent to which a particular projection is realized. Such factors may include, but are not limited to, changes in implementation of Hansa Biopharma’s strategy and its ability to further grow; risks and uncertainties associated with the development and/or approval of Hansa Biopharma’s product candidates; ongoing clinical trials and expected trial results; the ability to commercialize imlifidase if approved; changes in legal or regulatory frameworks, requirements, or standards; technology changes and new products in Hansa Biopharma’s potential market and industry; the ability to develop new products and enhance existing products; the impact of competition, changes in general economy and industry conditions and legislative, regulatory and political factors. The factors set forth above are not exhaustive and additional factors could adversely affect our business and financial performance. We operate in a very competitive and rapidly changing environment, and it is not possible to predict all factors, nor can we assess the impact of all factors on our business or the extent to which any factor, or combination of factors, may cause actual results to differ materially from those contained in any forward-looking statements. Given these risks and uncertainties, investors should not place undue reliance on forward-looking statements as a prediction of actual results. Hansa Biopharma expressly disclaims any obligation to update or revise any forward-looking statements to reflect changes in underlying assumptions or factors, new information, future events or otherwise, and disclaims any express or implied representations or warranties that may arise from any forward-looking statements. You should not rely upon these forward-looking statements after the date of this presentation. 2

  3. Hansa Biopharma at a glance Company background …at Hansa …a sa Biopharma we envi visi sion • Founded 2007 with HQ in Lund, Sweden • Sören Tulstrup, CEO – Ulf Wiinberg, Chairman a world where all patients s with rare • 64 employees (~3/4 in R&D) at Sep 30, 2019 immunologic dise sease ses s can lead • Operations in Sweden, US & Europe • Market cap: SEK ~6bn (USD ~600m) Oct, 2019 long and healthy y live ves. s... • Listed on Nasdaq OMX Stockholm (HSNA) Leader in immunomodulatory enzymes for rare IgG-mediated diseases • Imlifidase is a unique IgG antibody-cleaving enzyme • Imlifidase has been studied in five clinical studies and published in peer-reviewed journals (e.g. New England Journal of Medicine and the American Journal of Transplantation) • If approved, Imlifidase may have the potential to meet a large unmet need and transforming the lives of people with rare disease Broad pipeline in transplantation and autoimmune diseases • Lead indication in kidney transplantation in highly sensitized patients (MAA under review by EMA) • Anti-GBM antibody disease (Phase 2) • Antibody mediated kidney transplant rejection (AMR) (Phase 2) • Guillain-Barré syndrome (Phase 2) • NiceR - Recurring treatment in autoimmune disease, transplantation and oncology (Preclinical) • EnzE – Cancer immunotherapy (Preclinical) Key Financials • Cash position 9m’19 SEK 680m • Operating Cash Flow 9m’19 SEK -260m • R&D cost 9m’19 SEK -135m • Net Profit 9m’19 SEK -249m 3

  4. Our Equity Story A unique immunomodulatory enzyme technology platform Imlifidase cleaves Potentially addressing A company well positioned Rich pipeline IgG antibodies a clear unmet need for commercial success • Imlifidase is a unique IgG • • Patients may become • We are leveraging our Hansa Biopharma is antibody-cleaving enzyme proprietary immuno-modulatory sensitized after losing a first establishing its own studied in five clinical studies. enzyme platform in phase 2 transplant or being exposed to commercial and medical clinical studies in rare foreign tissues through blood organization in EU and the US. • By removing the immunological autoimmune indications incl: transfusion or pregnancy. Outside these core markets we barrier, imlifidase has the will seek commercial potential to enable kidney • • Anti-GBM (Goodpasture’s) Such sensitized patients partnerships. transplantation in highly account for roughly 30% of • Guillain-Barré syndrome sensitized patients. • people on the kidney waiting Hansa Biopharma has a broad lists. patent coverage throughout • Acute AMR post 2035 in key markets and transplantation orphan drug designation in EU and US for imlifidase in kidney transplantation. 4

  5. Imlifidase, a novel approach with a rapid onset of action to eliminate pathogenic IgG with high specificity Origins from Imlifidase, a unique IgG Imlifidase inactivates Streptococcus pyogenes antibody-cleaving enzyme IgG in 2 hours • Species of Gram-positive, • • Interacts with Fc-part of IgG with extremely high specificity Rapid onset of action that spherical bacteria in the genus inactivates IgG below detectable • Cleaves IgG at the hinge region, generating one F(ab’) 2 Streptococcus level in 2 hours fragment and one homo-dimeric Fc-fragment • Usually known from causing a • IgG antibody-free window for strep throat infection approximately one week IgG in human serum 10 F(ab F( ab’) 2 8 imlifidase [IgG] (mg/mL) 6 n=10 patients IgG IgG 4 2 Fc Fc 0 0 0.5 h 1 h 2 h 4 h 6 h 8 h 1 d 2 d 3 d 7 d 14 d 21 d 28 d 64 d 5

  6. Broad pipeline in transplantation and auto-immune diseases Pivo votal Ca Candida didate te / / Rese search/ progra pro gram/ m/ Marke keting Next xt Anticipated Proje Pro jectin ting Indication Indication Pre Preclin linic ical Phase se 1 1 Phase se 2 Authoriza zation Marke keted Milest stone MAA revi view by y EMA Kidney y transp splantation in highly y se sensi sitize zed *) *) Fol Follow ow-up up meet eeting ng with h patients pa FDA Nov v 20, 2019 An Anti-GBM antibody y dise sease se Co Comple lete enrollm llment Imlifidase se Antibody y mediated ki kidney y transp splant Co Comple lete enrollm llment re rejection (A (AMR MR) Gu Guillain-Barré syn syndrome Co Comple lete enrollm llment Re Recurring treatment in autoimmune Deve velopment of CMC NiceR Nic dise sease se, transp splantation and oncology process ss / Tox Tox st studies EnzE zE Ca Cancer im immunotherapy Rese search phase se Completed Ongoing 1 Results from the Phase 1 study have been published, Winstedt el al. (2015) PLOS ONE 10(7). *) EMA: In imlifidase for kidney transplantation we have filed for conditional approval after completion of phase 2. A confirmatory study would need to be executed in case of approval. 6 FDA: Discussion on path forward in the US is still ongoing.

  7. Hansa Biopharma is financed through 2020 Solid cash position end of September 2019 Significant capital raised since 2007 900 858 Raised Raised Raised 800 759 763 SEK 545m SEK 453m SEK 185m (2015) (2017) (2018) 680 700 616 Capital Raised Cash position 575 600 SEK ~1.6bn 534 SEK ~0.7bn 483 500 SEKm since 2007 (Sep 30, 2019) 400 300 254 209 176 170 200 158 134 131 104 100 0 R&D investment SG&A spend (acc.) (acc.) -100 SEK ~0.3n SEK ~0.6bn Q4'15 Q1'16 Q2'16 Q3'16 Q4'16 Q1'17 Q2'17 Q3'17 Q4'17 Q1'18 Q2'18 Q3'18 Q4'18 Q2'19 Q3'19 Q119 (Since 2007) (Since 2007) Cash position Net loss Operating Cash Flow 7

  8. Upcoming milestones AMR Phase se 2 Nic NiceR cand candidat ate: e: An Anti-GBM Phase se 2 Comple Co lete Co Comple letio ion of GMP Co Comple lete enr enrol ollment ent enrol enr ollment ent process ss and IND- (ye year-end end 2019) 2019) (H (H2 2020) ) enabling enab ng tox ox st studies Imlifidase se in ki kidney y Imlifidase se in ki kidney y GBS Phase se 2 transp splantation transp splantation Co Comple lete Follow Fol ow-up up meet eeting ng with h CHM CHMP Opin inio ion enrol enr olment ent FDA Nov v 20, 2019 (H1 2020) (H (H (H1 2021) 2021) 2019 2020 2021 8

  9. Q3 Business Update Road Show Presentation Jan-Sep 2019 9

Recommend


More recommend