Advicenne Sa · EURONEXT:ALDVI
Advicenne Sa — Investor Presentation (May 2021)
20 slides from Advicenne Sa's investor presentation, May 2021
Slide 1: Corporate Presentation May 2021
CORPORATE PRESENTATION May 2021
Slide 2: Disclaimer
Disclaimer References herein to this presentation (the “Presentation”) shall mean and include this document, any oral presentation accompanying this document provided by Advicenne SA (the “Company”) and any further information that may be made available in connection with the subject matter containe
Slide 3: Overview
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Slide 4: Management Team with Proven Track Record
Management Team with Proven Track Record Dr. David H. Dr. André Robbie Didier Solomon Ulmann McCarthy Laurens Chairman Chief Medical GM CEO Officer Advicenne Inc. USA Corporate presentation | June 2021 4
Slide 5: Commercial stage speciality pharma
Advicenne is a Commercial stage speciality pharma focused on advancing ADV7103 (SibnayalR) in Rare Renal Diseases with High Unmet Need, including dRTA and Cystinuria in Europe and North America Corporate presentation | June 2021 5
Slide 6: Advicenne Highlight
Advicenne Highlight RARE RENAL PIPELINE PLATFORM Sibnayal™ : Commercialization in EU Unique Scientific Platform • EMEA approval obtained April 30, 2021 • Innovative galenic formulation of GRAS • Commercial partnerships under evaluation excipients • First launches in the EU scheduled for Q3 21 Enhanc
Slide 7: Advicenne 2.0 - Transformation Establishes a New Foundation for Value Creation
Advicenne 2.0 - Transformation Establishes a New Foundation for Value Creation New Senior Management Team Strong Industry and Financial Expertise in EU and USA Board Transformation FDA Endpoint Approval Two new members with guidance on Regulatory Deep expertise in clinical Pathway to Approval for de
Slide 8: Targeting Two Rare Renal Conditions with High Unmet Needs
Targeting Two Rare Renal Conditions with High Unmet Needs Rare genetic & acquired Devastating clinical impact Significant need for new therapies conditions Muscle aches and pains, fatigue, growth Primary/Inherited & failure, bone disease, kidney stones, dRTA Secondary/Acquired cardiac dysfunction an
Slide 9: Pipeline and Expected Milestones in Target Diseases
Pipeline and Expected Milestones in Target Diseases Preclinical / Next Milestones Product Indication Phase 2/3 Market Phase 1 (estimation) MA approval, 04/30, ADV7103 dRTA ARENA 1 Program 2021 Start S2 2021; ADV7103 Cystinuria CORAL 1 Program Expected MA (variation) S2 2022 Study resume S1 ADV7103 d
Slide 10: What is SIBNAYAL (ADV7103)
What is SIBNAYAL (ADV7103) Proprietary Formulation: Microgranules (2mm) of Potassium Citrate & Potassium Bicarbonate Fixed combination dose presentation, adjustable, oral route, tasteless Sequential and prolonged release of CK and BK over 12 hours Dissolution profile of potassium of ADV7103
Slide 11: Distal Renal Tubular Acidosis (dRTA)
Distal Renal Tubular Acidosis (dRTA) DISTAL RENAL TUBULAR The inability of the kidney to adequately excrete an acid (H+) load. ACIDOSIS Result of a genetic defect or secondary to other diseases SYMPTOMS Acidosis : low plasma bicarbonate – Potassium loss: low plasma potassium Impaired growth and fail
Slide 12: ADV7103 (dRTA) offers clear benefits
ADV7103 (dRTA) offers clear benefits ADV7103 Standard of Care (SoC) Strong efficacy ✓ 1 Sub-optimal efficacy (because need for multiple intakes) Only two doses a day (12h) enabling adequate Requires 3-6 intakes per day (risk of inadequate night coverage ✓ 2 night coverage) Normalizes plasma pota
Slide 13: ARENA – Pivotal EU Phase III Trial in dRTA: main results
ARENA 1 – Pivotal EU Phase III Trial in dRTA : main results Mean plasma bicarbonate level Gastro-intestinal adverse events Bone Markers Baseline Month 24 Month 36 Month 48 0,0 Z-score of the spine BMD -0,2 -0,4 -0,6 -0,8 -1,0 -1,2 GI treatment related AEs (dark colour GI AEs (full bar) of the bar) -
Slide 14: ADV7103 (Sibnayal): European Market Authorization on April 30, 2021
ADV7103 (Sibnayal™): European Market Authorization on April 30, 2021 Ready For EU dRTA Market Launch (Q3-Q4 2021) Partner Selection Manufacturing Preparations Selection of partner for European distribution Manufacturing agreement with Elaiapharm & commercialization, including local access (Lundbeck)
Slide 15: Cystinuria
Cystinuria Cystinuria Abnormal presence of cystine in urine resulting from a genetic defect Cystine precipitates and forms stones when urinary pH < 7.2 SYMPTOMS Recurrent stone formation Nephretic colics, passing stones, urinary tract obstruction DIAGNOSIS Stones containing cystine Presence of urina
Slide 16: Cystinuria clinical program with ADV7103
Cystinuria clinical program with ADV7103 Europe USA Positive clinical proof of concept ODD application submitted end Q1 2021 Increases urinary pH with only 2 doses per day Feedback anticipated Q3 2021 Clear-cut dose response on urinary pH US Strategy under review CORAL-1 Phase III stud
Slide 17: ARENA 2 – Design of Pivotal US Phase III Trial in dRTA
ARENA 2 – Design of Pivotal US Phase III Trial in dRTA ▪ B23CS1 – Pivotal study: A multicenter, placebo controlled, double-blind , randomized withdrawal study in 32 patients ▪ B24CS2 – Extension study (24 months) of B23CS Study design B23CS – Main study B24CS – Extension 32 patients 30 patients ADV7
Slide 18: Potential Newsflow (estimated timelines)
Potential Newsflow (estimated timelines) Timing News Apr 2021 2020 Account Closing Q2 2021 Sibnayal™ EU MA approval, dRTA Q2 2021 CFO Appointment & Management Augmentation Q2 2021 Commercial Partner selection Europe Q3 2021 US ODD positioning-- ADV7103 Cystinuria H2 2021 Neuroscience Business ‘spin
Slide 19: Financial highlights and shareholdings
Financial highlights and shareholdings1 Appr. €16.8M ($21M) in cash/cash equivalents on 31 Dec 2020 [€17.8M in June 2020] Company secured €4.3 million of non-dilutive 24% Floating financing through a PGE (French state 40% guaranteed loan) end of 2020. €12.5M debt facility authorization remaini
Slide 20: Why invest in Advicenne?
Committed to a focus on rare renal conditions Proprietary, innovative & market ready ‘formulation platforms’ ADV6209 (Ozalin®): First novel palatable oral solution (pediatric sedation)1 ADV7103: Novel oral formulation for rare renal diseases Why invest in Two late-stage clinical programs with st