Biosergen Ab · OMXSTO:BIOSGN
Biosergen Ab — IPO Roadshow (March 2021)
33 slides from Biosergen Ab's IPO roadshow presentation, March 2021
Slide 1: Management presentation
Management presentation March 2021
Slide 2: Disclaimer
Disclaimer This presentation is strictly confidential and may not be copied, published, distributed or transmitted in whole or in part, by any medium or in any form for any purpose. The information in this presentation is being provided by Biosergen AS (referred to as the “Company” or “Biosergen”) a
Slide 3: The transaction
The transaction Biosergen is going public to raise EUR 10-12 million to send its potential blockbuster antifungal into clinical development in the second half of 2021 Transaction overview Investment highlights Listing on NASDAQ First North Stockholm in Q2 2021 Lead program with blockbuster potential
Slide 4: Biosergen addresses one of the worst unmet medical needs
Biosergen addresses one of the worst unmet medical needs With more than 1.5 million deaths per year fungal infection is the overlooked health crisis Majority of systemic fungal infection-related deaths are Opportunistic fungal infections caused by four fungal pathogens: Candida, Aspergillus, Are inc
Slide 5: Pipeline leading to first product approval by 2026
Pipeline leading to first product approval by 2026 Biosergen’s lead compound BSG005 is about to enter clinical phase trials. Additional formulations to further increase the utility of the drug are close behind Pre- cGMP/ Phase Phase Phase Discovery clinical Tox 1 2 3 BSG005 2021 2022-23 2024-25 BSG0
Slide 6: Contents
Contents BSG005 Pre-clinical data Clinical program and market positioning Financials, ownership and management Appendix 6
Slide 7: BSG005 is a unique new antifungal
BSG005 is a unique new antifungal BSG005 belongs to the Polyene macrolide class of drugs but has been genetically improved Based on two decades of scientific work at Norwegian University of Original discovery from the Norwegian Science and Technology (NTNU) in Trondheim in collaboration with the Uni
Slide 8: Excellent scientific validation
Excellent scientific validation The decades long research effort behind BSG005 has been published in 23 peer reviewed publications 1. Sekurova O, Sletta H, Ellingsen TE, Valla S, Zotchev S: Molecular cloning and analysis of a pleiotropic regulatory gene locus from the nystatin producer Streptomyces
Slide 9: BSG005 has strong patent protection
BSG005 has strong patent protection Additional market exclusivity may be afforded by orphan and GAIN status Region IP protection (incl. extensions) Exclusivity protection after launch Composition of matter patent: 2033 Orphan drug protection**: 7 years USA New formulation patent*: 2041 GAIN
Slide 10: Contents
Contents BSG005 Pre-clinical data Clinical program and market positioning Financials, ownership and management Appendix 10
Slide 11: Pre-clinical data: An overview
Pre-clinical data: An overview BSG005 has been In vitro fungal strain Immunocompromised BSG005 showed at BSG005 has no through an extensive test showed broad mouse model showed equal dose levels a 3 nephrotoxicity, the in vitro and in vivo spectrum action, and excellent effects on – 4 times higher m
Slide 12: Efficacy against resistant strains
Efficacy against resistant strains BSG005 shows broad activity even against difficult-to-treat strains Candida Aspergillus C. Glabrata C. Albicans C. Albicans C. Glabrata (increased (fluconazole- (fluconazole- A. flavus A. fumigatus A. niger A. terreus Antifungals (sensitive) MIC Antifungals suscept
Slide 13: Superior performance at equal dose
Superior performance at equal dose Outperforms liposomal Amphotericin B in Aspergillosis and Candidiasis BSG005 vs ambisome against Candidiasis BSG005 vs ambisome against Aspergillosis 100 100 90 90 80 80 70 70 Survival (%) Survival (%) 60 60 50 50 40 40 30 30 20 20 10 10 0 0 1 2 3 4 5 6 7 8 9 10111
Slide 14: Higher Potency in candidiasis in Immunocompromised Mice (clinical dose)
Higher Potency in candidiasis in Immunocompromised Mice (clinical dose) Survival Data 100 N=50 90 80 70 Survival (%) 60 50 40 30 20 10 0 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 Days after infection BSG005 (0.7 mg/kg) BSG005 (0.35 mg/kg) AmBisome (5.4 mg/kg) AmBi
Slide 15: Comparison of Toxicology in Mice
Comparison of Toxicology in Mice BSG005 shows more than 5 times lower toxicity than Amphotericin B BSG005 shows significantly less toxicity in mice kidneys Enzyme marker: Urinary N-Acetyl-β-(D)- Acute toxicity in mice Glucosaminidase (NAG) 20 250 18 Δ U-NAG [nkat/mmol U-Crea] 200 * 16 14 150 12 mg/k
Slide 16: Safety
Safety BSG005 has superior safety data over other Polyenes, including liposomal Amphotericin B No genotoxicity Free of cardiovascular, central nervous and respiratory adverse effects No kidney toxicity 16
Slide 17: Contents
Contents BSG005 Pre-clinical data Clinical program and market positioning Financials, ownership and management Appendix 17
Slide 18: Clinical program designed to lead to NDA filing by end 2025
Clinical program designed to lead to NDA filing by end 2025 The company will file for orphan status for BSG005 to achieve expedited regulatory revue and prolonged market exclusivity The Company has applied for orphan drug status with the FDA and will shortly apply with the EMA Phase I The phase I tr
Slide 19: Early clinical study design
Early clinical study design The clinical program is designed to secure full indication profile of BSG005 Phase I trial design Phase II trial design - Still in planning The study is designed as a placebo-controlled, double-blinded The phase II program will have 3 to 4 studies: study. Up to sixty (60)
Slide 20: Development and value milestones
Development and value milestones Upcoming BSG005 key milestones Upcoming BSG005 key milestones 2021 2022 2023 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 1 2 3 4 5 6 7 The approval of an Initiate BSG005 A successful outcome Top line results from Initiate BSG005 Report the first top line Present the data and
Slide 21: Four pathogens are responsible for the majority of life threatening invasive fungal infections worldwide
Four pathogens are responsible for the majority of life threatening invasive fungal infections worldwide These are the fungal species targeted by Biosergen’s clinical program Pathogen Disease Incidence Share of market Systemic Candidiasis affect over 90,000 people in the US Approximately 52%of a
Slide 22: The global antifungal drug market is approx. USD 16 billion
The market global antifungal drug market is approx. USD 16 billion The three main classes of drugs – the Polyenes, the Azoles and the Echinocandins which together comprise more than 80% of the market - all focus on the fungal cell wall Antifungal 2019 sales Share of Projected annual Drugs in this cl
Slide 23: Contents
Contents BSG005 Pre-clinical data Clinical program and market positioning Financials, ownership and management Appendix 23
Slide 24: Financials
Financials Low burn rate with revenue from public grants P&L (SEKth) 2018 2019 Biosergen is a No-Research-Development-Only company Revenue - 4,843 that uses the vast majority of its financial researches on Other operating income 1,158 4,944 clinical development Total operating revenue 1,158 9,787 Ot
Slide 25: Management has led listed companies before
Management has led listed companies before Peder M. Andersen MD, Chief Executive Officer Niels Laursen, MBA, Chief Financial Officer Richard Forster, PhD, Chief Technical Officer Professional experience Professional experience Professional experience Chief Executive Officer at Biosergen AS since 2
Slide 26: Board with international late-stage clinical and commercial experience
Board with international late-stage clinical and commercial experience Torsten Goesch MD, MBA. PhD, Lena Degling Wikingsson, MD, Board member Achim Kaufhold, MD, Board member Chairman of the board Professional experience Professional experience Professional experience Dr. Torsten Goesch has been d
Slide 27: Board with international late-stage clinical and commercial experience
Board with international late-stage clinical and commercial experience Henrik Moltke, MSc (econ), Board member Mattias Klintemar, Board member Marianne Kock, Board member Hanne Mette Kristensen, Board member Professional experience Professional experience Professional experience Professional experie
Slide 28: Business model and vision
Business model and vision The company will file for orphan status for BSG005 to achieve expedited regulatory review and prolonged market exclusivity US/EU Business model To develop BSG005, including any derivatives and novel formulations of this compound, into the new first line treatment choice for
Slide 29: Supportive and knowledgeable shareholders
Supportive and knowledgeable shareholders Management with skin in the game Name Number of shares held Share of votes and capital Östersjöstiftelsen 44,983,666 41% Rosetta Capital1 44,323,098 41% SINTEF Venture 9,364,145 9% Fred Management2 5,699,525 5% Karolinska Development 4,506,669 4% Total 108,8
Slide 30: Biosergen
ed; Biosergen
Slide 31: Contents
Contents BSG005 Pre-clinical data Clinical program and market positioning Financials, ownership and management Appendix 31
Slide 32: Comparison of Kidney Toxicology in 30 days GLP Studies in Rats
Comparison of Kidney Toxicology in 30 days GLP Studies in Rats BSG005 shows no signs of nephrotoxicity in rats after 30 days BSG005 * AmBisome ** (Liposomal Amphotericin-B) In doses of 0.25, 1 and 2 mg/kg/d A NOAEL could not be BSG005 administration was not determined since urinary associated with a
Slide 33: Comparison of Kidney Toxicology in 30 days GLP Studies in Dogs
Comparison of Kidney Toxicology in 30 days GLP Studies in Dogs BSG005 shows no signs of nephrotoxicity in dogs after 30 days BSG005 * AmBisome ** (Liposomal Amphotericin-B) In doses of 0.3, 1 and 3 mg/kg/d A NOAEL of AmBisome BSG005 administration was not administered to dogs for 30 days associated