H1 2021 I Euronext: ALBPS – Nasdaq: BPTS Forward Looking Statements
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H1 2021 I Euronext: ALBPS – Nasdaq: BPTS 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 (the “Company”) and its products, along with other statements about the future expectations, beliefs, goals, plans, or prospects expressed by management constitute forward-looking statements. Any statements that are not historical fact (including, but not limited to, statements that contain words such as “will,” “believes,” “plans,” “anticipates,” “expects,” “estimates”) should also be considered to be forward-looking statements. By their nature, forward-looking statements involve risks and uncertainties, including, without limitation, risks inherent in the development or commercialization of potential products, uncertainty in the results of clinical trials or regulatory approvals, need and ability to obtain future capital, and other risks discussed in the Company’s registration statement on Form F-1 and other reports filed with the Securities and Exchange Commission (the “SEC”), which are available for review at http://www.sec.gov/. Actual results may differ materially from the results anticipated in these forward-looking statements and as such should be evaluated together with the many uncertainties that affect the Company's business. Any forward-looking statements that we make in this presentation speak only as of the date of such statement, and we undertake no obligation to publicly update or review such statements to reflect events or circumstances after the date of this presentation, except as required by law. 2 Corporate Highlights HQ location: Paris, France Biophytis SA is a clinical-stage biotechnology company specialized in the development of therapeutics that are aimed at slowing the degenerative processes Founded: 2006 associated with aging and improving functional outcomes for patients suffering from age-related diseases. Our small molecules are aimed at stimulating biological resilience and are developed through a drug discovery platform based on a reverse Employees: 30 pharmacology approach. Euronext growth (ALBPS) : July 2015 Sarconeos (BIO101), our leading drug candidate, is a small molecule, administered orally, being developed as a treatment of mobility disability in elderly patients with Nasdaq (BPTS): February 2021 sarcopenia in a Phase 2 clinical study (SARA) in the United States and Europe. It is also being studied for the treatment of severe respiratory manifestations in COVID- 19 in a Phase 2-3 clinical study (COVA) in Europe, Brazil, and the US. A pediatric Market cap: €117M (May 11, 2021) formulation of Sarconeos (BIO101) is being developed with IND granted (MYODA) for the treatment of Duchenne Muscular Dystrophy (DMD). Cash: €18.8 M as of December 31, 2020 Key partner: Sorbonne University 3 Executive team Samuel Agus - CMO Stanislas Veillet - Founder & CEO • MD, PhD, Board-certified • PhD in genetics, AgroParisTech Neurologist • 25+ years in biotech; Pharmacia- • 15+ years pharma/biotech Monsanto, Danone Group experience including Abbott, Shire and Teva Pharmaceuticals Pierre Dilda - CSO Waly Dioh - COO • PhD in pharmacology (Paris V) • PhD in phytopathology (Paris XI) • 25 years experience in and MBA pharmaceutical research, in both • 21+ years biotech experience in academic and industrial settings France and the U.S. and R&D at Monsanto Evelyne Nguyen- CFO • 30+ years of experience in Corporate Finance for International Pharma & Biotech companies (BMS, LFB, Nicox SA, ANMPartners) • Expertise in cross-borders transactions between Europe, US and Asia 4 Drug discovery for age-related diseases • Sarconeos (BIO 101) Reverse pharmacology from plant natural molecule for neuromuscular and stimulating biological resilience to drug candidates respiratory diseases • Macuneos (BIO201) for eye diseases Build a Screen in Selection of proprietary cellular models best drug collection of of age related candidates • Small molecules: natural and/or natural molecules diseases and based on NCE (new chemical entity) & analogs from identification animal models • New key target against aging medicinal plant, of targets & of aging or produced under pathways genetic • Preclinical proof-of-concept & safety biotic or abiotic diseases • IP on use, process and composition stress of matter • Second generation drug candidates (BIO103, BIO203) DAPI MHC 5 Our clinical pipeline Candidate Indication Program Preclinical Phase 1 Phase 2 Phase 3 Covid-19 COVA Sarconeos (BIO101) Sarcopenia DMD Dry AMD Macuneos (BIO201) Stargardt 6 2020: A transformational year for Biophytis Clinical Achievements Financial achievements Launch of the new COVA study – COVID-19 • $20.1 million (€16.6 M) raise from • Part 1 first interim analysis achieved (50 patients) with positive Nasdaq IPO in Q1 2021 DMC review in Q1 2021 • Part 2 steadily progressing with 155 patients recruited in May. • €23.4 million raise in private placements The second interim analysis is expected before end Q2 2021 on Euronext in 2020 • Top line results for the full study are expected Q3 2021 • €18.8 million in cash and cash Completion of SARA-INT study recruitment – Sarcopenia equivalents as of December 31, 2020 • Phase 2: Treatment completed for the last patient in December 2020 • Top-line results expected in Q2 2021 IND Approval to start MYODA - DMD • US IND & Belgium authorization obtained • Study to start by H1 2021 depending on the evolution of the pandemic 7 Sarconeos (BIO101) activates MAS receptor, triggering key pathways for muscle metabolism, with the potential to stimulate mobility and respiratory functions Sarconeos (BIO101) triggers two important MAS receptor downstream signaling-pathways Sarconeos in myocytes: (BIO101) • PI3K/AKT/mTOR: Increases MAS protein synthesis Receptor • AMPK/ACC: Stimulates energy production MAS activation in skeletal and smooth muscles stimulates muscle metabolism and strength with a potential impact on mobility or respiratory functions Protein Energy Synthesis Production AKT AMPK Pathway Pathway 8 Sarconeos (BIO101) activates the protective arm of the Renin Angiotensin System (RAS) with the potential to stimulate respiratory function in COVID-19 patients • Sarconeos (BIO101) activates the MAS receptor, a key component of Renin SARS-CoV2 the protective arm of the Renin- (Covid-19) Angiotensin System (RAS), known for protecting muscles against catabolism, inflammation or Ace fibrosis Ace2 • The production of Ang 1-7, the Sarconeos (BIO101) natural ligand of MAS receptor, is impaired by SARS-CoV-2, which RAS RAS uses ACE2 to penetrate the lungs, classical protective causing respiratory failures arm arm Muscle • Sarconeos (BIO101) by reactivating catabolism the RAS protective arm, has the Inflammation potential to restimulate respiratory fibrosis capacity in COVID-19 patients. senescence 9 Sarconeos (BIO101) improves muscle strength and mobility in animal models Preservation of muscle strength Beneficial effect on mobility in immobilized mice in aged mice fed with high fat diet1 Administration of 50 mg/kg/day of Administration of 50 mg/kg/day of Sarconeos (BIO101) demonstrated a preservation of Sarconeos (BIO101) demonstrated a statistically muscle strength while immobilized (d0-d14) significant (p<0.01) improvement in maximum compared to vehicle control in hind limb- running velocity (Vmax) compared to “old” control immobilized mice mice, compensating almost completely for the loss of mobility due to aging 1. Results were presented in a poster at the SCWD conference in December 2016 in Berlin, Germany. 10 Sarconeos (BIO101) improves respiratory functions in animal models Improves lungs Improves respiratory function mechanical (Plethysmography) properties (Flexivent) Chronic (8 week) daily administration of C57BL10-mdx mice treated with 50 50 mg/kg/day of Sarconeos (BIO101) mg/kg/day of Sarconeos (BIO101) over 8 statistically significantly (p<0.001) weeks showed an improvement in airway improved lungs mechanical properties responsiveness (PenH) as compared to measured by airway resistance untreated control C57BL10-mdx mice Results were presented in October 2019 during the WMS conference in Copenhagen with posters, and in March 2019 at the annual international congress of Myology in Bordeaux, France 11 Sarconeos (BIO101) results in Phase 1 study (SARA-PK) ELDERLY HEALTHY VOLUNTEERS Sarconeos (BIO101) showed a dose dependent effect on biomarkers of muscle growth and repair (PIIINP) and a dose dependent negative effect on muscle wasting (myoglobin) Single and multiple ascending doses tested in 54 healthy adult and elderly (over 65 years) volunteers Safety profile: No Severe Adverse Events Two active doses (175 & 350 mg b.i.d.) have been selected for the upcoming Phase 2 studies 12 COVA Study: targeting hospitalized patients with respiratory failure, and not intubated Targeted populations Severe cases: signs of respiratory Critical cases: de-compensation, not Patients aged 45 and above, with proven COVID-19, requiring requiring ventilation and severe respiratory symptoms: mechanical • With evidence of respiratory decompensation ventilation ≤7 days before start of study medication, meeting one 5% 45+ of the following: 14% • Tachypnea: ≥ 25 breaths per minute • Arterial oxygen saturation ≤92% 81% Allowed medications: Adapted from Wu et al. • Antiviral agents such as Remdesivir, Bamlanivimab, JAMA, 2020 • Anti- inflammatory agents such as Dexamethasone Mild cases: infection without or with mild signs of pneumonia