Bioporto A/s · OMXCOP:BIOPOR
Bioporto A/s — HC Andersen Capital/Nordea Small Cap Seminar 2020
31 slides from Bioporto A/s's conference presentation, Dec 15, 2020
Slide 1: BioPorto presentation @ HC Andersen Capital/Nordea Small Cap Seminar
BioPorto presentation @ HC Andersen Capital/Nordea Small Cap Seminar December 15, 2020 © Copyright BioPorto CONFIDENTIAL
Slide 2: Forward-Looking Statements
Forward-Looking Statements References herein to this presentation shall mean and include this document, any oral presentation accompanying this document provided by BioPorto A/S (the “Company”) and any further information that may be made available in connection with the subject matter contained her
Slide 3: Agenda
1 About BioPorto Agenda 2 Acute Kidney Injury 3 A Novel Solution: The NGAL Test 4 The Addressable Market 5 NGAL Regulatory Strategy 6 A Development Platform - gRAD 7 Summary CONFIDENTIAL 3 CONFIDENTIAL
Slide 4: About BioPorto
About BioPorto • Research assays ELISA Kits • Clinical diagnostics BioPorto is an in vitro diagnostics company that provides tests and antibodies to clinicians and researchers around the world. We use our antibody and assay expertise to • The NGAL Test transform novel research tools into clinically
Slide 5: Mission, Vision and Strategy
Mission, Vision and Strategy BioPorto helps healthcare providers improve patient management and outcomes with products that provide early and specific insights into significant clinical conditions. By 2025, we aspire to be one of the world’s leading companies in diagnostics for kidney health. Establ
Slide 6: Experienced International Management Team
BioPorto’s leadership Experienced International Management Team Peter Mørch Eriksen CEO CEO of BioPorto since July 2013 20+ years in medtech/life sciences, including CEO of Sense A/S and VP/GM of Medtronic Amy Winslow Ole Larsen Jan Kuhlmann President, Christopher Bird CFO COO BioPorto Diagnostics I
Slide 7: Acute Kidney Injury
Significant Unmet Need Acute Kidney Injury © Copyright BioPorto CONFIDENTIAL 7
Slide 8: Many Patients at Risk
Why is Acute Kidney Injury (AKI) important ? Many Patients at Risk Is affected with AKI during hospitalization, and during admission to the ICU, respectively *Kidney transplant rate is in children; Stem cell is rate in children/adults 1) O’Neal JB, Crit Care. 2016;20(1). 2) Alobaidi R, Semin Nephrol
Slide 9: AKI is a Major Public Health Concern
The unsolved problem AKI is a Major Public Health Concern Third Leading Cause of Death AKI-associated In-hospital Mortality Annual US deaths: 2,813,50310 In hospital AKI9 285,768 All Other Heart Disease10 Causes10 647,457 1,281,170 Rate among non-diabetic adults; among diabetics the increase was 139
Slide 10: Clinical Burden Inside & Outside the Hospital
Clinical Burden Inside & Outside the Hospital IN-HOSPITAL 3 YEARS POST-DISCHARGE • 30% higher risk of hospital readmission14 • 38% more likely to have a major cardiac event15 • Up to 25% progress to Increased Increased Use Increased Overall Chronic Kidney Disease (CKD)17 Length of Stay12 of Dialysis
Slide 11: Cardiac Markers Highlight Innovation Needed in AKI
Cardiac biomarkers vs. kidney biomarkers Cardiac Markers Highlight Innovation Needed in AKI Patients with 40% probable AKI missed by consensus criteria22 A similar proportion to that identified by troponin in subjects with myocardial injury missed by conventional cardiac biomarkers.23 AMI: Acute Myo
Slide 12: The NGAL Test
A Novel Solution The NGAL Test The NGAL Test is CE marked and available for IVD use in the European Union, Canada, S. Korea and Israel. For research use only in all other territories. © Copyright BioPorto CONFIDENTIAL 12
Slide 13: An Early Warning System for Kidney Injury
AKI assessment tools: NGAL vs. Standard of Care An Early Warning System for Kidney Injury Neutrophil Gelatinase Serum Creatinine (sCr) Associated Lipocalin (NGAL) • A non-specific marker • Small protein of kidney function27 expressed in • Delayed: peaks 48-72 neutrophils & certain hours after injury
Slide 14: NGAL(+) Identifies Poorer Outcomes
Utility of integrating NGAL with sCr reveals four phenotypes NGAL(+) Identifies Poorer Outcomes Multicenter pooled analysis (2011) evaluated 10 prospective observational studies including 2,322 critically ill patients Utility of integrating NGAL with sCr revealed four phenotypes: Both negative: Pati
Slide 15: NGAL Predicting Tubular Injury
Case Study: 4-month old with history of hypoplastic left heart syndrome, with respiratory failure requiring mechanical ventilation NGAL Predicting Tubular Injury Case Highlights Corresponding to Numbered Arrows29 1. After 4 days in the CICU, nephrology was consulted due to rising creatinine levels w
Slide 16: Potential Benefits Across the Healthcare Ecosystem
The NGAL Test* Potential Benefits Across the Healthcare Ecosystem Patients Providers Faster identification of AKI risk Better triage decisions Earlier interventions to limit Avoid unnecessary tests/therapies kidney damage Faster feedback on interventions Fewer missed cases of AKI Core Lab Hospitals
Slide 17: The Addressable Market
The Addressable Market © Copyright BioPorto CONFIDENTIAL 17
Slide 18: Addressing a Significant Unmet Need
Market Opportunity for The NGAL Test Addressing a Significant Unmet Need Markets & Indications Global Opportunity Expanded Indications Long Term Expansion • Exclusion in the ED • Monitoring ~150M tests; $3Bn • Drug Toxicity • Trauma/Triage Adult ICU Risk Assessment Submit following pediatric clearan
Slide 19: Driving Commercialization Through Partnerships
Planned evolution of commercial activities for The NGAL Test* Driving Commercialization Through Partnerships BioPorto ion Establish Clinical Value ut KOL relationships Sol Commercialization Roles Clinical Studies v el Papers, Posters & Podium No Enable Rapid Uptake Key Account Focus Hospital relatio
Slide 20: Regulatory Strategy
Regulatory Strategy © Copyright BioPorto CONFIDENTIAL 20
Slide 21: Regulatory Strategy for NGAL
Regulatory Strategy for NGAL Pediatrics Adults Additional Indications • Nephrotoxicity − Oncology − Cardiology 1 in 4 affected with AKI during hospitalization 1 in 5 adults affected with AKI − Diabetes (ICU)31 during a hospital episode of care32 − Transplant − Autoimmune Predict AKI Risk in Predict
Slide 22: A Development Platform
BioPorto’s gRAD A Development Platform © Copyright BioPorto CONFIDENTIAL 22
Slide 23: Highlights gRAD
BioPorto’s patented lateral flow development system Highlights gRAD • Rapid development of lateral flow tests See how gRAD works • High accuracy – same level as the ELISA test • Multi sample types – plasma, urine, soliva etc. • Semi-quantitative test result • Fast test – from sample to result ~10 mi
Slide 24: Platform for Product Development & Growth
gRAD Platform for Product Development & Growth NGAL COVID Leveraging the gRAD platform, BioPorto is developing tests for NGAL as well as three emerging applications: Viral 1. NGAL: for near-patient assessment of kidney injury gRAD 2. COVID-19: a viral diagnostic test Platform 3. COVID-19: a serology
Slide 25: NGALds for Near-Patient Testing
NGALds for Near-Patient Testing • NGALds is the first assay developed on the gRAD platform • CE Mark expected in Q4 2020 • A rapid lateral flow test to offer semi-quantitative urine NGAL results without complexity or instrumentation – idea for outpatient or low-resource settings • A sandwich lateral
Slide 26: Generic Rapid Assay Device (gRAD) platform
Generic Rapid Assay Device (gRAD) platform Positive Negative BioPorto’s patented Generic Rapid Assay Device (gRAD) technology is a lateral flow test development platform with no analyte-specific reagents on the strip. Instead, labelled capture antibodies and gold nanoparticle conjugated detection an
Slide 27: COVID-19 viral test development process
COVID-19 viral test development process Assay Development Timeline Analytical Clinical trial Start patient Clinical testing agreements enrollment testing Clinical Regulatory results submissions © Copyright BioPorto CONFIDENTIAL 27
Slide 28: 2020 Milestones
2020 Milestones © Copyright BioPorto CONFIDENTIAL 28
Slide 29: Targeted 2020 Milestones
Clinical, regulatory and commercial Targeted 2020 Milestones • Finalize collection of data for the FDA application of The NGAL Test for pediatrics and submit application in the second half of 2020 • Collect supplementary data to support submission of an application for The NGAL Test in adults • Co-d
Slide 30: ~$17m Financing Finalized in October
Fully Subscribed Rights Offering ~$17m Financing Finalized in October Developing new indications using the gRAD platform, expectedly within the areas of COVID-19, Sepsis and Inflammation $2.5m Developing the Company’s U.S. organization Funding of current operations, including to prepare for an FDA c
Slide 31: Financial Calendar 2021
Financial Calendar 2021 March 17, 2021 Annual report 2020 April 29, 2021 Annual General Meeting May 12, 2021 Q1 2021 Results August 18, 2021 Q2 2021 Results November 17, 2021 Q3 2021 Results Contact: Ole Larsen (CFO) ol@bioporto.com © Copyright BioPorto CONFIDENTIAL
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