Slide 1: May 2024 | Euronext: ALBPS – Nasdaq: BPTS
May 2024 I Euronext: ALBPS – Nasdaq: BPTS
Slide 2: Forward Looking Statements
Forward Looking Statements This presentation contains forward-looking statements. Forward-looking statements include all statements that are not historical facts. In some cases, you can identify these forward-looking statements by the use of words such as «outlook », «believes», «expects», «potentia
Slide 3: Clinical-stage biotechnology company for muscular, respiratory and metabolic diseases
A clinical-stage biotechnology company specialized in the development of therapeutics for muscular, respiratory and metabolic diseases HQ location: Paris, France Multiple partnerships Other locations in Sao Paulo, BR and Cambridge, MA US Founded: 2006 Euronext growth Paris (ALBPS) Nasdaq NYC (BPTS)
Slide 4: Biophytis' People: Expertise & Passion
BIOPHYTIS’ People : Expertise & Passion Stanislas Veillet CEO, cofounder Rob van MAANEN Pierre DILDA Edouard BIETH Chief Medical Officer Chief Scientific Officer Chief Business Officer Waly DIOH Nicolas FELLMANN Chiara BACCELLI Chief Operations Officer Chief Financial Officer Chief Pharmaceutical Op
Slide 5: Our Clinical Pipeline as of today
Our Clinical Pipeline as of today xxx orphan diseases
Slide 6: BIO101 (20-hydroxyecdysone): Mechanism of Action
BIO101 (20-hydroxyecdysone) : Mechanism of Action BIO101 (20-hydroxyecdysone) BIO101 (20-hydroxyecdysone) triggers two important MAS receptor downstream signaling-pathways in myocytes: PI3K/AKT/mTOR: Increases protein synthesis AMPK/ACC: Stimulates energy production MAS activation in muscles stimula
Slide 7: BIO101 is currently in development in 4 indications
BIO101 (20-hydroxyecdysone) is currently in development in 4 indications Targeted Clinical functions function function Targeted Indications
Slide 8: BIO101 in Sarcopenia
BIO101 (20-hydroxyecdysone) in SARCOPENIA
Slide 9: Sarcopenia is an aged related disease
Sarcopenia is an aged related disease Sarcopenia is a syndrome defined by many consortia including the EWGSOP (The European Working Group on Sarcopenia in Older People) and the SDOC (Sarcopenia definitions and Outcomes Consortium), characterized by progressive and generalized loss of skeletal muscle
Slide 10: Sarcopenia is estimated to influence 10–16% of the elderly 60+
Sarcopenia is estimated to influence 10 % – 16% of the elderly 60+ p o p u l a t i o n worldwide. Prevalence of Sarcopenia among patients aged 60+ Source : Yuan 2023, Epidemiology of Sarcopenia, Metabolism; Shafiee 2017, Prevalence of Sarcopenia in the world, Journal of diabetes & metabolic disorder
Slide 11: No pharmacological treatment has yet been approved
There is no d r u g treatment registered for sarcopenia No pharmacological Vitamins/dietary supplements treatment has yet These may improve muscle strength and muscle mass, but no solid clinical been approved evidence for either frailty or sarcopenia. Recommendations for the prevention and treatment
Slide 12: Our solution for patients suffering from sarcopenia
Our solution for patients suffering from sarcopenia BIO101 (20-hydroxyecdysone): First drug candidate to complete Phase 2 (SARA-INT) with clinically meaningful outcome on mobility On track to prepare the Phase 3 program, through approvals of CTA and granted by EMA and FDA Other drug candidates inclu
Slide 13: SARA-INT: Phase 2 trial overview
SARA-INT: Phase 2 trial overview Design Endpoints Patient Population Global, double-blind, randomized, placebo- Primary Age: 65 years old or over controlled trial: NCT03452488 Gait speed in the 400-meter walk Low mobility measured by Short Performance Assess safety and efficacy of two doses of test
Slide 14: Promising results obtained in SARA-INT phase 2 trial
Promising results obtained in SARA-INT phase 2 trial BIO101 (20-hydroxyecdysone) significantly improves the 400 MWT gait speed, the primary endpoint, in the PP population after 6 months of treatment Change from baseline at M6 Gait speed Global, double-blind, randomized, placebo-controlled trial in p
Slide 15: SARA-31 – Phase 3 development plan
SARA-31 – Phase 3 development plan Design Endpoints Patient Population Global, double-blind, randomized, phase 3 Primary Age: 65 years old or over placebo-controlled trial Major Mobility Disability (MMD) Low mobility measured by Short Performance Assess safety and efficacy of BIO101 assessed by the
Slide 16: BIO101 in Obesity
BIO101 (20-hydroxyecdysone) in Obesity
Slide 17: Muscle wasting associated with pharmacology treatment of obesity: an unmet medical need
Muscle wasting associated with p h a r m a c o l o g y t r e a t m e n t o f obesity: an unmet medical need Obesity is a serious chronic disease 1bn 3x $4tn Adults and children are currently The global cost of treating The global prevalence of obesity living with obesity globally. obesity-related co
Slide 18: 13% of US adults would be treated with anti-obesity medication by 2030
According to analysts, 13% of US adult population would be treated with an anti-obesity medication by 2030 2023 CAGR “In 2030, we estimate that ~15mn adults +42% 2030 in the US will be treated with AOM for Total Market chronic weight management (excluding patients treated for type 2 diabetes), 6 bUS
Slide 19: Potential attributes of BIO101 in obese patients treated with GLP-1RA
Potential attributes of BIO101 (20-hydroxyecdysone) in obese patients treated with GLP-1RA Effects on muscle wasting: Preservation of muscle strength Reduction of muscle mass loss Improvement of mobility Effects on fat tissues: Increase of fat mass loss Convenient and safe administration : Oral rout
Slide 20: Supportive preclinical data in obesity
Supportive preclinical data in obesity Metabolic effects in obese mice : Protective effect of BIO101 (20-hydroxyecdysone) in mice fed an obesity-inducing high-fat diet, preventing adipose tissue development (Foucault et al., 2012) Anti-obesity effect by increase in energy expenditure (Foucault et al
Slide 21: Promising clinical data in obese patients on hypocaloric diets
Promising clinical data in obese patients on hypocaloric diets for weight-loss Android fat mass Handgrip strength (p=0.0386) patients with weight loss >5% (p=0.0974) 2 M e a n grip strenght (Kg) [Variations] 0,0 Android fat mass (%) [Variations] 1 -0,5 20E -1,0 0 Placebo -1 -1,5 Placebo 20E -2,0 -2
Slide 22: OBA – Phase 2 development plan
OBA – Phase 2 development plan Design Endpoints Patient Population Randomized, double-blind, placebo-controlled Primary 164 obese patients treated with GLP-1 phase 2 trial Muscle strenght (knee extension) RAs, together with hypocaloric dieting Assess efficacy a n d safety of BIO101 Obese patients (B
Slide 23: BIO101 in SARIs (Severe Acute Respiratory Infections)
in SARIs (Severe Acute Respiratory Infections) RuvembriTM is the marketing name for BIO101 (20-hydroxyecdysone) in Covid-19 indication
Slide 24: Global Respiratory Infection treatment market will reach more than 100bUSD by 2031
Global Respiratory Infection treatment market will reach more than 100bUSd by 2031 Medical research, increasing awareness and government initiatives will drive market growth 2031 Total Market 2023 CAGR Total Market +8,5% 57 bUSD 108 bUSD Source : DataBridge Report on Respiratory Viral Infections 202
Slide 25: Covid treatments represent 29% of the Respiratory Infections market
In 2023, Covid treatments represent 29% of the Respiratory Infections market Global treatment market by virus type (2023) COVID Rhinovirus (Common Cold) Respiratory Syncytial Virus (RSV) Influenza (FLU) Parainfluenza Adenoviruses Enterovirus Others Source : DataBridge Report on Respiratory Viral Inf
Slide 26: 17% of patients hospitalized for Covid are still dying
17% of patients hospitalized for Covid are still dying What’s happening in reality ? Patient hospitalized for severe COVID19 53% 68y Number of comorbidities : 1,2% Main symptoms : Admission to ICU : 16% Acute Respiratory Failure : 27% Mean Stay in ICU : 15 days Main comoborbidities : Atrial Fibrilia
Slide 27: COVA Study: Targeting Hospitalized Patients with severe respiratory symptoms
COVA Study: Targeting Hospitalized Patients with severe respiratory symptoms due COVID-19 Severe cases: hospitalized with hypoxemia, tachypnea or pneumonia Patients aged 45 and above, with proven COVID-19, and severe respiratory symptoms: Critical cases : With evidence of respiratory decompensation
Slide 28: Phase 2-3 COVA clinical study of Ruvembri in severe COVID-19
Phase 2-3 COVA clinical study to evaluate of RuvembriTM in the treatment of severe forms of COVID-19 Administration of 350 mg b.i.d of BIO101 Global, multi-center, double-blind, placebo-controlled group Phase 2-3 Design sequential (2 parts) adaptive design International study including 37 clinical c
Slide 29: Positive results: respiratory failure or early death
Positive results strongly supporting therapeutic potential of RuvembriTM in severe COVID-19 : respiratory failure or early death Respiratory Failure or early death : The study met primary endpoint Proportion without respiratory failure or early death, Kaplan-Meier Analysis, ITT population Reduction
Slide 30: Positive results: mortality and safety
Positive results strongly supporting therapeutic potential of RuvembriTM in severe COVID-19 : mortality and safety Proportion without death, Mortality follow-up over 90 days and safety : Kaplan-Meier Analysis, ITT population Kaplan Meier post hoc analysis showed a reduction in the risk of 1,0 death
Slide 31: Biophytis initiates market access processes for BIO101 in severe COVID-19
Biophytis initiates market access processes for BIO101 treatment of severe forms of COVID-19 Early access : EAP in France : application for early access will be re-submitted in 2024 EAP in Brazil: new application to be submitted to ANVISA for an EAP program, with initiation expected in 2024
Slide 32: BIO101 in Duchenne Muscular Dystrophy
BIO101 (20-hydroxyecdysone) in Duchenne Muscular Dystrophy
Slide 33: The life of patients with Duchenne Muscular Dystrophy (DMD)
The life of patients with Duchenne Muscular Dystrophy (DMD) Orphan genetic disease affecting 1/5,000 boys at birth (220,000 patients worldwide) ”Duchenne is every child and parents’ worst nightmare come true“ (Victoria, Mother of Dougie) 0 to 2 yo 5 yo 12 yo 19 yo 25 yo 30 yo No symptoms Motor delay
Slide 34: There is no effective treatment
There is no effective treatment Despite research progress, no treatment is able to cure or effectively control the progression of the disease Corticosteroids (Prednisone, deflazacort, vamorolone) They are the standard of care, but their use is controversial and not uniformly recommended. Mobility lo
Slide 35: Late-stage patients are neglected
Late-stage patients are neglected 38 clinical candidates 4 clinical 2 clinical (mainly, therapies) candidates candidates Presymptom Early ambulatory Late ambulatory Early non-ambulatory Late non-ambulatory stage stage stage stage stage No approuved drug for their specific respiratory problems Exclud
Slide 36: BIO101 in DMD: Experts and Stakeholders insights
BIO101 (20-hydroxyecdysone) in DMD : Experts and Stakeholders insights BIO101 in DMD : the experts speak “Your molecule could be life-changing “Potential benefits of BIO101, including : for Duchenne patients” The indication to all DMD patients no matter gene (French Muscular Dystrophy Association, A
Slide 37: Our solution: A first-in-class medication
Our solution: A first-in-class medication BIO101 (20-hydroxyecdysone) aims to improve Improvement in airway responsiveness breathing capacity (PenH) in C57BL10-mdx mice. Each bar represents 6 Mean +/- SEM p <0.001 4 PenH 2 n = 12 n = 12 n = 12 0 C57BL10 mdx mdx 20E Source: Dilda et al. Neuromuscular
Slide 38: Our solution: A first-in-class medication
Our solution: A first-in-class medication BIO101 (20-hydroxyecdysone) aims to improve non ambulatory patients breathing capacity New therapeutic class Remarkable activity in preclinical models HO OH New molecular target Ease of administration H OH Validated mechanism of action 2 Activation of MAS re
Slide 39: Preparing to start phase 1-2 clinical study in DMD
Preparing to start phase 1-2 clinical study in DMD Design Endpoints Patient Population A Randomized, Double-Blind, multi-center Primary Age: ≥12 years old Phase 1-2 Study change from baseline in Non-ambulatory DMD patients Forced vital capacity (FVC) Patients at risk of respiratory failure Evaluate
Slide 40: Key milestones in the development of BIO101
Key milestones in the development of BIO101 (20-hydroxyecdysone) Achieved in the last 12 months Anticipated in the next 12 months Authorization to start phase 3 SARA-31 study in Start of phase 3 SARA-31 study depending on Belgium and the US partnership Start of OBA phase 2 study pending regulatory P
Slide 41: Scientific Advisory Board
Scientific Advisory Board Pr. Jean Mariani, President Professor of neuroscience and biology of aging and Director of Charles Foix Institute of Longevity at Sorbonne University Emeritus Professor (PU-PH) at the Sorbonne University’s School ofMedicine René Lafont Dr. Roger Fielding Pr. Bernard Levy Co
Slide 42: Financial data
Financial data Shareholding structure Key financial figures Management US Institutional Listing Euronext (ALBPS) and Nasdaq (BPTS) Investors 2% 11% Cash position: EU Institutional €5.6m (December 31, 2023) Retail Investors €5.4m raised and €4m in convertible bonds 15% drawn down since June 2023 72%
Slide 43: Thank You
THANK YOU Contacts : Stanislas Veillet – CEO Investors relation : stanislas.veillet@biophytis.com investors@biophytis.com Nicolas Fellmann – CFO nicolas.fellmann@biophytis.com Edouard Bieth – CBO edouard.bieth@biophytis.com www.biophytis.com