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 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
Hansa Biopharma at a glance Company background …at Hansa Biopharma we envision a • Founded 2007 with HQ in Lund, Sweden worl rld d where re all p pat atients ts with rare re • Sören Tulstrup, CEO – Ulf Wiinberg, Chairman • 64 employees (~3/4 in R&D) at Sep 30, 2019 immunologic disease ases can l lead long • Operations in Sweden, US & Europe • Market cap: SEK ~6bn (USD ~600m) Oct, 2019 and healthy lives... • 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
Imlifidase – a novel approach to eliminate pathogenic IgG Origins from Imlifidase, a unique IgG Imlifidase inactivates Streptococcus pyogenes antibody-cleaving enzyme IgG in 2 hours Species of Gram-positive, spherical • • Interacts with Fc-part of IgG with extremely high specificity • Rapid onset of action that bacteria in the genus Streptococcus inactivates IgG below detectable • Cleaves IgG at the hinge region, generating one F(ab’) 2 fragment level in 2 hours Usually known from causing a strep • and one homo-dimeric Fc-fragment throat infection IgG antibody-free window for • approximately one week F(ab’) 2 imlifidase IgG Fc Fc 4
Hansa Biopharma, a company well positioned for a commercial success Imlifidase cleaves Potentially addressing A company well positioned Rich pipeline IgG antibodies a clear unmet need for commercial success Imlifidase is a unique IgG We are leveraging our proprietary • Patients may become sensitized Hansa Biopharma is establishing • • • antibody-cleaving enzyme immuno-modulatory enzyme after losing a first transplant or its own commercial and medical studied in five clinical studies. platform in phase 2 clinical being exposed to foreign tissues organization in EU and the US. studies in rare autoimmune through blood transfusion or Outside these core markets we By removing the immunological • indications incl: pregnancy. will seek commercial barrier, imlifidase has the partnerships. potential to enable kidney • Anti- GBM (Goodpasture’s) • Such sensitized patients account transplantation in highly for roughly 30% of people on the Hansa Biopharma has a broad • • Guillain-Barré syndrome sensitized patients. kidney waiting lists. patent coverage throughout • Acute AMR post 2035 in key markets and orphan transplantation drug designation in EU and US for imlifidase in kidney transplantation. 5
Broad pipeline in transplantation and auto-immune diseases Pivota votal Mark rketi ting ng Candid idate te / Research rch/ program/ Authoriza rizati tion Next t Anticip icipate ted Projecti ting ng Indica icati tion Precl clinica inical Phase se 1 1,2 Phase se 2 Revi view Mark rkete ted Mile lesto stone ne MAA review w by EMA Kidney y transpl plan anta tati tion in highly y sensiti tized d Follow ow-up up meeting ng with h patien ents ts *) *) FDA Nov v 20, 2019 Anti-GB GBM antibo body dy disease ase Compl mplete enrol ollme ment nt Imlifida dase se Antibo body dy mediated ated kidney ey transpl plan ant t Compl mplete enrol ollme ment nt reje jecti tion (AMR) Guillain-Ba Barré ré syndro rome me Compl mplete enrol ollme ment nt Recurri ring trea eatm tmen ent t in autoimm mmune e Develop opment of CMC NiceR disease ase, transpl plan antati tation and oncology proc ocess / Tox studi dies EnzE Cancer er immunother erap apy Research h pha hase Completed Ongoing 1 Results from the Phase 1 study have been published, Winstedt el al. (2015) PLOS ONE 10(7) 2 Kidney transplantation in highly sensitized patients” with reference to “ Results from Phase 2 studies have been published in N Engl J Med 2017; 377:442-453 and in Am J Transplant. 2018 Nov;18(11):2752-2762. *) 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.
Hansa Biopharma is financed through 2020 Solid cash position end of September 2019 Significant capital raised since 2007 858 900 Raised Raised Raised 759 763 800 SEK 185m SEK 545m SEK 453m (2015) (2017) (2018) 680 700 616 Capital Raised 575 Cash position 600 534 SEK ~1.6bn SEK ~0.7bn 483 SEKm 500 since 2007 (Sep 30, 2019) 400 300 254 209 176 170 158 200 134 131 104 100 0 R&D investment SG&A spend (acc.) (acc.) -100 SEK ~0.3bn SEK ~0.6bn (Since 2007) (Since 2007) Cash position Net loss Operating Cash Flow 7
Upcoming milestones AMR Phase e 2 NiceR candidate: date: Anti-GB GBM Phase e 2 Complete ete Completi etion of GMP Complete ete enrollmen ent enrol ollmen ment (H2 proces cess s and IND- (year ear-en end d 2019) 2020) enabl bling tox studies es Imlifida dase se in kidney ey Imlifida dase se in kidney ey GBS Phase se 2 transpl splan antati tation transpl splan antati tation Complete ete CHMP Opinion (H1 Follow-up p meeti ting with enrolment ent 2020) 2020) FDA Nov 20, 2019 (H1 2021) 2021) 2019 2020 2021 8
Q3 Business Update Road Show Presentation Jan-Sep 2019 9
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