Biophytis Sa · EURONEXT:ALBPS
Biophytis Sa — IPO Roadshow (July 2019)
32 slides from Biophytis Sa's IPO roadshow presentation, Jul 9, 2019
Slide 1: Forward Looking Statements
Forward Looking Statements 2 All statements pertaining to future financial and/or operating results, future growth in research, clinical development, and potential opportunities for Biophytis SA (the “Company”) and its products, along with other statements about the future expectations, beliefs, goa
Slide 2: Free Writing Prospectus Statement
Free Writing Prospectus Statement 3 This presentation highlights basic information about us and the offering to which this communication relates. We have filed a registration statement on Form F-1 (including a preliminary prospectus) with the SEC for the offering to which this presentation relates.
Slide 3: Overview
4 Overview Sarconeos (BIO101) for sarcopenia Sarconeos (BIO101) for DMD Macuneos (BIO201) for dry AMD
Slide 4: A clinical-stage biotechnology company in age-related diseases
A clinical-stage biotechnology company in age-related diseases 5 Improve functional outcomes (mobility, strength and vision) and healthspan for patients suffering from age-related diseases Neuromuscular diseases Retinal diseases Our goal Our lead drug candidate Sarconeos (BIO101) is in clinical deve
Slide 5: Aging and biological resilience pathways
Aging and biological resilience pathways 6 As we age, our physical (mobility and strength) and visual performances decline due in part to the accumulation of multiple stresses we are exposed to during our lifetime We believe this is contributed to by the decline in biological resilience, the natural
Slide 6: Aging and biological resilience pathways
Aging and biological resilience pathways The global elderly (260) As we age, our physical (mobility and strength) and population is projected to visual performances decline due in part to the more than double by 2050? accumulation of multiple stresses we are exposed to during our lifetime 2050 We be
Slide 7: Overview
8 Overview Sarconeos (BIO101) for sarcopenia Sarconeos (BIO101) for DMD Macuneos (BIO201) for dry AMD
Slide 8: Sarconeos (BIO101) potential mechanism of action: Activates the MAS receptor
Sarconeos (BIO101) potential mechanism of action: Activates the MAS receptor 9 MAS is a key component of the renin-angiotensin system (RAS) We believe MAS activation triggers three downstream pathways which may preserve muscle strength, function and mobility in various age-related and muscular wasti
Slide 9: Sarconeos (BIO101) preclinical data in animal models for sarcopenia
Sarconeos (BIO101) preclinical data in animal models for sarcopenia suggests improvements in mobility and strength 10 Administration of 50 mg/kg/day of Sarconeos (BIO101) demonstrated a statistically significant (p<0.01) improvement in maximum running velocity (Vmax) compared to “old” control mice,
Slide 10: Sarcopenia is an unmet medical need with no approved drugs
Sarcopenia is an unmet medical need with no approved drugs 11 Age-related degeneration of skeletal muscle characterized by a loss of muscle mass, strength and the ability to stand and/or walk A major cause of mobility disability in the elderly (65 years) resulting in a loss of independence and incre
Slide 11: SARA-INT: Ongoing Phase 2b clinical trial
Global, multicenter, double-blind, randomized, placebo-controlled trial in 334 elderly patients with sarcopenia at risk of mobility disability SARA-INT: Ongoing Phase 2b clinical trial 12 Objectives Key Endpoints Subpopulation Analysis Product 2019 2020 175 & 350 mg (twice daily) of Sarconeos (BIO10
Slide 12: SARA-INT: Recruiting patients at risk of mobility disability
SARA-INT: Recruiting patients at risk of mobility disability 13 Recruitment Recruiting in U.S. and Belgium with 15 sites currently open; expanding to 22+ sites Awaiting approval to open additional sites in other countries, including France Enrollment began in May 2018 with complete enrollment expect
Slide 13: SARA-PK: Phase 1 trial completed in 2017
SARA-PK: Phase 1 trial completed in 2017 14 Sarconeos (BIO101) showed a dose dependent effect on muscle growth and repair (PIIINP) and a dose dependent negative effect on muscle wasting (myoglobin) PD SUMMARY IN MAD PHASE P1 TRIAL SAFETY RESULTS Single and multiple ascending doses tested in 54 healt
Slide 14: Overview
15 Overview Sarconeos (BIO101) for sarcopenia Sarconeos (BIO101) for DMD Macuneos (BIO201) for dry AMD
Slide 15: DMD is an unmet medical need with no cure and limited treatment options
DMD is an unmet medical need with no cure and limited treatment options 16 Rare, genetic neuromuscular disease in male children characterized by accelerated degeneration of muscles, responsible for loss of mobility, respiratory failure and cardiomyopathy, leading to premature death No known cure and
Slide 16: Proof of concept in mdx mice models of DMD
Proof of concept in mdx mice models of DMD: Improvements in mobility, strength and respiration 17 Chronic (8 week) daily administration of 50 mg/kg/day of Sarconeos (BIO101) significantly (p<0.001) improved respiratory function measured by airway resistance Improved mobility as measured by running d
Slide 17: MYODA-INT: Seamless clinical trial design
18 Design Patients Product 2020 2021 2022 2023 Sarconeos (BIO101) MYODA-INT (Part 1/2) Ambulatory and non-ambulatory DMD patients: Part 1/2: 48 patients Part 3: ~100-150 patients Enrollment in the U.S. and EU Patient advocacy group support AFM telethon in France Global, multicenter, double-blind, pl
Slide 18: MYODA-INT: Potential composite score based on function
MYODA-INT: Potential composite score based on function 19 Seamless Design Composite Endpoints Strength Respiratory function Strength Mobility Composite endpoints adapted to the stage of severity of the disease in each patient Clinical relevance endpoints
Slide 19: Overview
20 Overview Sarconeos (BIO101) for sarcopenia Sarconeos (BIO101) for DMD Macuneos (BIO201) for dry AMD
Slide 20: Dry AMD is an unmet medical need with no approved drugs
Dry AMD is an unmet medical need with no approved drugs 21 AMD is a common eye disorder among people over 50 that affects the central part of the retina, known as the macula Can impair functions such as reading, driving, and facial recognition, and has a major impact on QoL and the ability to live i
Slide 21: Macuneos (BIO201) potential mechanism of action: Non-canonical activation of PPARs
Macuneos (BIO201) potential mechanism of action: Non-canonical activation of PPARs 22 Anti-inflammatory activity (promotes the expression of anti-inflammatory genes) We believe Macuneos (BIO201) potentially counteracts the phototoxic effects of A2E by selective non-canonical activation of the transr
Slide 22: Macuneos (BIO201) proof of concept in rodent models of dry AMD
Macuneos (BIO201) proof of concept in rodent models of dry AMD: Protects the retina 23 Intraperitoneal injection of Macuneos (BIO201) preserved the number of layers of photoreceptors by up to approximately 90% at the maximum dose of 100M in a standard blue light rat model Preservation of visual func
Slide 23: Key milestones
Key milestones 24 SARA-OBS completed enrollment of 218 patients in Oct. 2018 SARA-INT (Phase2b) enrolled first patient in May 2018 SARA-INT (Phase2b) expected to complete patient enrollment in 2020 MYODA-INT received orphan drug designation in 2018 in U.S. and EU MYODA-INT plan to make IND and EU re
Slide 24: Executive team
Executive team 25 Stanislas Veillet - Founder & CEO PhD in genetics, AgroParisTech 25+ years in biotech; Pharmacia-Monsanto, Danone Group René Lafont - Co-founder & CSO Professor emeritus and former Dean of the life sciences department at Sorbonne University 185 scientific articles + 59 reviews and
Slide 25: Scientific advisors
26 Dr. Ivana Kim Associate Professor Harvard Medical School, Massachusetts Eye and Ear Co-Director of the Harvard Medical School Department of Ophthalmology AMD Center of Excellence; Associate Scientist, Massachusetts Eye and Ear Dr. Thomas Voit Professor, University College London Director of the R
Slide 26: Board of directors
Board of directors 27 Nadine Coulm - Independent Board Member IR Director for Korian 20 years of IR experience with FNAC BNP Paribas, Danone & Casino Jean M. Franchi - Independent Board Member Merrimack Pharma CFO 30+ years as finance director, including 15 years at Genzyme Dimitri Batsis - Independ
Slide 27: Key statistics
Key statistics 28 Stock profile Market: Euronext Growth (Paris) Ticker: ALBPS Shares outstanding: 13,463,413 Fully diluted shares: 15,365,322 Share price as of July 8, 2019: €0.88/share Market capitalization: €11.8M Public Float 88.3% Management & Board
Slide 28: APPENDIX A: Preclinical proof of concept
29 APPENDIX A: Preclinical proof of concept
Slide 29: Sarconeos (BIO101) increased myotube diameter in cellular models
Sarconeos (BIO101) increased myotube diameter in cellular models 30 Human myotubes are larger in muscle cells treated with Sarconeos (BIO101) as compared to untreated control cells Enlarging myotubes, the main structural units of muscle, may be an important factor for limiting muscle mass loss and i
Slide 30: Sarconeos (BIO101) proof of concept in mdx mice models of DMD: respiratory function
Sarconeos (BIO101) proof of concept in mdx mice models of DMD: Improvements in respiratory function 31 Chronic (8 week) daily administration of 50 mg/kg/day of Sarconeos (BIO101) significantly (p>0.001) improved respiratory function, as measured by airway resistance, elastance and PenH (enhanced pau
Slide 31: Macuneos (BIO201) increased RPE cell survival in cellular models
Macuneos (BIO201) increased RPE cell survival in cellular models 32 Macuneos (BIO201) may increase survival of primary porcine RPE cells in the presence of A2E and blue light 1. These results were presented in May 2016 at the ARVO conference in Seattle, WA in a poster presentation and published in P
Slide 32: Macuneos (BIO201) increased RPE cell survival in cellular models
Macuneos (BIO201) increased RPE cell survival in cellular models + Macuneos (BIO201) may protect RPE cells from cell death, in a dose-dependent manner, against the photo-oxidative stress induced by blue light in the presence of A2E Each bar represents Mean «/- SEM 5 separate experiments with n=4 poo