Biophytis Sa · EURONEXT:ALBPS
Biophytis Sa — Investor Presentation (January 2020)
33 slides from Biophytis Sa's investor presentation, Jan 27, 2020
Slide 1: January 2020 I Euronext, EPA: ALBPS
January 2020 I Euronext, EPA: ALBPS
Slide 2: Forward Looking Statements
Forward Looking Statements All statements pertaining to future financial and/or operating results, future growth in research, clinical development, and potential opportunities for Biophytis SA and its subsidiaries (the “Company”) and its products, along with other statements about the future expecta
Slide 3: A clinical-stage biotechnology company in age-related diseases
A clinical-stage biotechnology company in age-related diseases Our goal Neuromuscular diseases Retinal diseases Prevent disabilities (mobility and Lead candidate BIO101 (Sarconeos) Pre-clinical drug candidates vision) and increase health span developed in : Macuneos (BIO201, BIO203) for patients suf
Slide 4: Modern drug discovery process, inspired by traditional medicine
Modern drug discovery process, inspired by traditional medicine Our technology Reverse pharmacology for drug candidates ▪ BIO 101: Muscular Dystrophy ▪ BIO 201:Retinopathy in Age Related diseases ▪ Followed by BIO103 & BIO203 Build a proprietary Screen in Selection of collection of cellular models b
Slide 5: Our clinical pipeline for worldwide development
Our clinical pipeline for worldwide development • Second generation drug candidates, BIO103 and BIO203, are life-cycle extension candidates in the preclinical Phase 5
Slide 6: Executive team
Executive team Samuel Agus - CMO Stanislas Veillet - Founder & CEO • MD, PhD, Board-certified Neurologist • PhD in genetics, AgroParisTech • 15+ years pharma/biotech experience • 25+ years in biotech; Pharmacia-Monsanto, including Abbott, Shire and Teva Danone Group Pharmaceuticals Pierre Dilda - CS
Slide 7: Scientific advisory board
Scientific advisory board Pr. Jean Mariani Dr. Roger Fielding • Professor of neuroscience and biology of aging • Professor of Medicine, Tufts University School of and Director of Charles Foix Institute of Medicine Longevity at Sorbonne University • Director and Sr. Scientist Jean Mayer USDA Human •
Slide 8: Board of directors
Board of directors Stanislas Veillet - Founder & CEO Pr. Jean Mariani • PhD in genetics, AgroParisTech • Professor of neuroscience and biology of aging • 25+ years in biotech; Pharmacia-Monsanto, Danone and Director of Charles Foix Institute of Group Longevity at Sorbonne University • Emeritus Profe
Slide 9: From a Sorbonne University spin-off to a successful clinical-stage biotechnology company
From a Sorbonne University spin-off to a successful clinical-stage biotechnology company • Initiated SARA- INT Phase 2b • IPO on Alternext clinical trial • Incorporated on Paris that raised €10.0 M • Received orphan Sept 26, 2006 drug designation • First patents • Opened U.S. for Sarconeos filed in
Slide 10: Sarconeos (BIO101) for sarcopenia
Overview Sarconeos (BIO101) for sarcopenia Sarconeos (BIO101) for DMD Macuneos (BIO201) for dry AMD 10
Slide 11: Sarcopenia: a large unmet medical need with no approved drug
Sarcopenia: a large unmet medical need with no approved drug • Age-related degeneration of skeletal muscle characterized by a loss of muscle mass, strength and functional issues such as the ability to stand and/or walk • A major cause of mobility disability, resulting in a loss of independence and i
Slide 12: Sarconeos (BIO101) activates MAS receptor, a key factor for muscle metabolism
Sarconeos (BIO101) activates MAS receptor, a key factor for muscle metabolism • MAS receptor: a key component of the Renin-Angiotensin System (RAS) • Trigger three important downstream pathways in myocytes: PI3K/AKT/mTOR: Increases protein synthesis, preserving muscle mass and increasing muscle stre
Slide 13: Sarconeos (BIO101) improves muscle strength and mobility in animal model
Sarconeos (BIO101) improves muscle strength and mobility in animal model Beneficial effect on mobility Preservation of muscle strength in aged mice fed with high fat diet1 in immobilized mice Administration of 50 mg/kg/day of Administration of 50 mg/kg/day of Sarconeos (BIO101) demonstrated a statis
Slide 14: Quinolia study: effect on muscle strength in healthy volunteers
Quinolia study: effect on muscle strength in healthy volunteers TREATMENT WITH OUR COMPOUND COMPENSATES THE DIET’S EFFECT ON MUSCULAR STRENGTH • Objective: test the effect of our compound on muscle wasting caused by dieting • Double-blind, placebo-controlled, nutrition study (dieting), 58 healthy ob
Slide 15: SARA-PK: Phase 1 trial in elderly healthy volunteers showed good safety and activity
SARA-PK: Phase 1 trial in elderly healthy volunteers showed good safety and activity Sarconeos (BIO101) showed a dose dependent effect on muscle growth and repair (PIIINP) and a dose dependent negative effect on muscle wasting (myoglobin) • Single and multiple ascending doses tested in 54 healthy ad
Slide 16: SARA-OBS: An OBServational trial to select patients with severe sarcopenia
SARA-OBS: An OBServational trial to select patients with severe sarcopenia at risk of mobility disability Objectives Key Endpoints Inclusion criteria • To characterize sarcopenia, Primary • Men and women aged ≥ 65 including sarcopenic obesity, • 400-meter walk test years, living in the in older pati
Slide 17: SARA-OBS: targeted population is at high risk of mobility disability
SARA-OBS: targeted population is at high risk of mobility disability Mobility pattern at baseline as Decrease of walking ability (400 MWT Gait measured by actimetry Speed) over 6 months 400 MWT (m/sec) 0.91 0.9 0.89 0.88 0.87 0.86 0.85 0.84 0.83 0.82 0.81 Baseline M6 Enrolled patients show low mobil
Slide 18: SARA-INT: on going Phase 2b clinical trial in sarcopenia
SARA-INT: on going Phase 2b clinical trial in sarcopenia • Global, multicenter, double-blind, randomized, placebo-controlled trial • 334 elderly patients with sarcopenia at risk of mobility disability Objectives Key Endpoints Inclusion Criteria Subpopulation Analysis Primary • Age (≥65 or over) • As
Slide 19: SARA-INT: complete enrollment expected mid 2020
SARA-INT: complete enrollment expected mid 2020 “The SARA-INT Phase 2 trial is investigating a new treatment for sarcopenia, a disease of aging which Belgium is characterized by loss of muscle mass and function. Following the supportive preliminary data, this trial will evaluate the efficacy of BIO1
Slide 20: SARA-INT: results expected end of 2020
SARA-INT: results expected end of 2020 Objectives Inclusion Criteria Subpopulation Analysis Product 2019 2020 175 & 350 mg SARA-INT (twice daily) of Phase 2b Sarconeos (BIO101) • No safety issue to date, with multiple DSMB “may proceed” opinions • Interim analysis in Q2 2020 for assessing probabilit
Slide 21: Sarconeos (BIO101) for Duchenne's muscular dystrophy (DMD)
Overview Sarconeos (BIO101) for sarcopenia Sarconeos (BIO101) for Duchenne’s muscular dystrophy (DMD) Macuneos (BIO201) for dry AMD 21
Slide 22: DMD: No cure and limited treatment options
DMD: No cure and limited treatment options Proportion of • Rare, genetic neuromuscular disease in male children ambulatory class characterized by accelerated degeneration of muscles, in DMD1 responsible for loss of mobility, respiratory failure and cardiomyopathy, leading to premature death. 100% 90
Slide 23: Proof-of-concept in mdx mice models of DMD
Proof-of-concept in mdx mice models of DMD: Improvements in mobility, strength and respiration Improved muscle strength, as Improves the time-dependent Improved mobility as measured by measured by four-limb grip-test degradation of respiratory running distance1 force1 function2 C57BL10-mdx mice trea
Slide 24: MYODA-INT: IND granted by FDA to start Phase 1-2 in 2020
MYODA-INT: IND granted by FDA to start Phase 1-2 in 2020 Product 2020 2021 2022 2023 Sarconeos (BIO101) MYODA-INT (Phase 1-2) Design Patients Regulatory Status • Global, multicenter, double-blind, • Ambulatory and/or non- • Pre-IND correspondence with placebo-controlled, seamless, ambulatory DMD pat
Slide 25: Intellectual Property portfolio – Neuromuscular diseases
Intellectual Property portfolio – Neuromuscular diseases • We hold exclusive commercial rights through licenses of each of our drug candidates. • IP is jointly owned with Sorbonne University & sometimes with other academic research institutions1. • Patent portfolio covers 9 patent families, includin
Slide 26: Macuneos (BIO201) for dry AMD
Overview Sarconeos (BIO101) for sarcopenia Sarconeos (BIO101) for DMD Macuneos (BIO201) for dry AMD 26
Slide 27: Dry AMD is an unmet medical need with no approved drugs
Dry AMD is an unmet medical need with no approved drugs Projection of AMD prevalence in North America (in M, mean • AMD is a common eye disorder among people over 50 that projection)1 affects the central part of the retina, known as the macula 25 • Can impair functions such as reading, driving, and
Slide 28: Macuneos (BIO201) mechanism of action: Non-canonical activation of PPARs
Macuneos (BIO201) mechanism of action: Non-canonical activation of PPARs • We believe Macuneos (BIO201) potentially counteracts the phototoxic effects of A2E by selective non-canonical activation of the transrepressive activity of PPAR⍺ and PPAR/ in the retina • Most other PPAR ligands mainly exhi
Slide 29: Macuneos (BIO201) protects the retina in rodent models of dry AMD and Stargardt disease
Macuneos (BIO201) protects the retina in rodent models of dry AMD and Stargardt disease Preservation of Reduced A2E Dose-dependent protection visual function in mice accumulation in mice of retina integrity in rats Chronic oral administration of Chronic oral administration of Intraperitoneal injecti
Slide 30: Macuneos (BIO201) clinical development is the next asset for value creation
Macuneos (BIO201) clinical development is the next asset for value creation • Phase 1 (MACA-PK): First-In-Human, Phase 1, randomised, double-blind, placebo- controlled, mono-centre study evaluating single (SAD) and multiple ascending oral doses (MAD) of Macuneos (BIO201) in healthy subjects 18 years
Slide 31: Intellectual Property portfolio – Retinal Diseases
Intellectual Property portfolio – Retinal Diseases • We hold exclusive commercial rights through licenses of each of our drug candidates. • IP is jointly owned with Sorbonne University & sometimes with other academic research institutions. • Patent portfolio covers 5 patent families, including a tot
Slide 32: Key milestones
Key milestones ✓ ❑ SARA-OBS completed study of 218 patients in April 2019 with last patient out ❑ SARA-INT (Phase2b) interim results analysis in Q2 2020 ❑ SARA-INT (Phase2b) complete patient enrollment in mid 2020 ❑ SARA-INT (Phase2b) topline results expected by end of 2020 ✓ ❑ MYODA IND clearance b
Slide 33: Thank you
CONTACTS: ▪ Stanislas Veillet – CEO stanislas.veillet@biophytis.com ▪ Evelyne NGUYEN – CFO evelyne.nguyen@biophytis.com Thank you Investor relations: investors@biophytis.com Website: www.biophytis.com 33