Poxel Sa · EURONEXT:POXEL
Poxel Sa — H1 2020 Earnings Presentation
28 slides from Poxel Sa's earnings presentation, Sep 15, 2020
Slide 1: First Half 2020 Financial and Corporate Update
First Half 2020 Financial and Corporate Update September 15, 2020 1
Slide 2: Disclaimer
Disclaimer Some of the statements contained in this presentation constitute forward-looking statements. Statements that are not historical facts are forward-looking statements. Forward-looking statements generally can be identified by the use of forward-looking terminology such as “may”, “will”, “ex
Slide 3: 1H 2020: Significant R&D and Corporate Accomplishments
1H 2020: Significant R&D and Corporate Accomplishments 1 Imeglimin for Type 2 Diabetes (T2D) • Japanese New Drug Application submission by Sumitomo; product launch targeted for 2021* • Metavant regulatory discussions for Ph 3 program in patients with T2D and CKD stages 3b/4 2 PXL770 for NASH • Posit
Slide 4: Financial Update
Financial Update First Half 2020 4
Slide 5: Statement of Comprehensive Income as of June 30, 2020
Statement of Comprehensive Income as of June 30, 2020* Revenue Mainly Reflects Milestone Payment from Sumitomo Dainippon Pharma for the Imeglimin J-NDA Submission in Japan In K€ H1 2020 H1 2019 1 • Revenue includes a €4.1 million (adjusted)** milestone payment from Sumitomo 1 Revenue 6,372 19,164 Da
Slide 6: Statements of Financial Position as of June 30, 2020
Statements of Financial Position as of June 30, 2020* Assets In K€ June 30, Dec. 31, 1 • Reflects DeuteRx portfolio acquisition. 2020 2019 2 • Accrued milestone payment and re- 1 Intangible assets 16,641 16,614 invoicing to Sumitomo Dainippon Pharma Property, plant and equipment 2,442 2,323 for the
Slide 7: Statements of Financial Position: Shareholders' Equity and Liabilities
Statements of Financial Position as of June 30, 2020* Shareholders’ Equity and Liabilities In K€ June 30, Dec. 31, 2020 2019 1 • Reflects the H1 2020 net loss and the 1 Total shareholders' equity 45,307 39,142 €17.7m capital increase in May. Non-current liabilities 2 • Mainly IPF loan (€6.5m from tr
Slide 8: Statements of Cash Flow as of June 30, 2020
Statements of Cash Flow as of June 30, 2020* €9m Increase in Cash in H1 2020 In K€ June 30, 2020 June 30, 2019 (adjusted)** Cash flows from operating activities before change in WC (10,516) (8,948) (-) Changes in working capital requirements 4,022 2,742 1 • Reflects May capital increase of Cash flow
Slide 9: Key Financial & Shareholder Information
Key Financial & Shareholder Information Market data Shareholder ownership** 14.3% Andera Partners 18.1% 53.1% Bpi France Ticker: POXEL Floating ISIN: FR0012432516 9.5% Founders Number of shares: 28,495,523* 5.0% Roivant Sciences Key financials Analyst coverage Ltd Degroof Petercam Benoit Louage • As
Slide 10: Corporate Update
Corporate Update First Half 2020 10
Slide 11: Imeglimin: Type 2 Diabetes, Global Partnerships
Type 2 Diabetes Imeglimin Global Partnerships First in a New Class of Potential Anti-diabetic Therapies with a Differentiated Mechanism of Action 11
Slide 12: Successful Completion of Phase 3 Program in Japan
1 Successful Completion of Phase 3 Program in Japan JNDA Under Review; Target Launch 20211 Partnership Details • Sumitomo commercialization partner for Japan, China and 11 other East and Southeast Asian countries2 Poxel led Phase 3 TIMES program in >1,100 • Future potential development milestone pay
Slide 13: Imeglimin Development Strategy for the US & EU
1 Imeglimin Development Strategy for the US & EU Targeting Type 2 Diabetes Patients with Chronic Kidney Disease (CKD) Stages 3b/4 Partnership Details • Upfront payment: $35M1 • Development and commercialization partner in the US, Europe, and other • Equity Investment: $15M at €8.5/share countries* •
Slide 14: PXL770: NASH
NASH PXL770 Proprietary Program Direct AMPK Activator for the Treatment of NASH 14
Slide 15: PXL770: Encouraging Clinical Results Observed (n=148)
2 PXL770: Encouraging Clinical Results Observed (n=148) Dose-Dependent PK; Favorable Safety/Tolerability; Target Engagement; Efficacy Signals Phase Phase11Healthy HealthySubjects Subjects(n=132) (n=132) PK/PD Trial: Obese, Insulin Resistant (n=16) • Linear, dose-proportional exposure with single • F
Slide 16: PXL770 PK/PD Study Demonstrated Target Engagement and Efficacy Signals
2 PXL770 PK/PD Study Demonstrated Target Engagement and Efficacy Signals Fructose-stimulated de novo lipogenesis • Inclusion criteria: controlled attenuation parameter (CAP) 30 Versus baseline (at week 4) (N=12) score >300 db/m (measured by FibroScan®) and HOMA- 25 DE NOVO LIPOGENESIS (%) IR* score
Slide 17: PXL770: Ongoing Phase 2a Program for NASH
2 PXL770: Ongoing Phase 2a Program for NASH Phase 2a 12-week, Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel Group Trial • N = 100 likely-NASH patients with and without Type 2 diabetes • Inclusion criteria: increased hepatic fat (assessed via CAP and MRI-PDFF) • Trial to assess
Slide 18: PXL065: NASH
NASH PXL065 Proprietary Program MPC Inhibitor for the Treatment of NASH Utilizing the 505(b)(2) Regulatory Pathway 18
Slide 19: PXL065: Single Phase 2 Trial in Biopsy-Proven NASH Patients
3 PXL065: Single Phase 2 Trial in Biopsy-Proven NASH Patients Leveraging 505(b)(2) Pathway A 36-week multicenter, double-blind, placebo-controlled, parallel group, randomized trial to evaluate the safety and efficacy of PXL065 at 3 doses in ~120 noncirrhotic biopsy-proven NASH patients Double-blind
Slide 20: NASH Combinations
Additional Opportunities NASH Combinations 20
Slide 21: Pre-Clinical Data Demonstrate Potential Synergy of PXL770/AMPK Activation
4 Pre-Clinical Data Demonstrate Potential Synergy of PXL770/AMPK Activation with Other Agents in Development PXL770 Other PXL770 / Semaglutide (GLP-1) Mechanisms Liver lipid content Mouse NASH Model 1500 Liver lipid content (mg) Effects in #### Adipose Tissue # 1000 Low grade inflammation **** ****
Slide 22: Pipeline Expansion
Additional Opportunities Pipeline Expansion Chronic and Rare Metabolic Indications Next Generation AMPK Activators Next Generation D-TZD’s* *Deuterium-modified thiazolidinediones 22
Slide 23: AMPK and MPC Dysregulation are Implicated in Various Metabolic Diseases
5 AMPK and MPC Dysregulation are Implicated in the Biology of Various Metabolic Diseases AMPK MPC Acetyl Co-A Pyruvate TCA cycle ATP NADH FADH2 MRC Activates Inhibits T catabolic Inhibits inflammation pathways anabolic apoptosis pathways MITOCHONDRIA Exploring applications of current and next genera
Slide 24: Potential of AMPK Activation to Treat Adrenoleukodystrophy
5 Potential of AMPK Activation to Treat Adrenoleukodystrophy ALD AMN Why AMPK ? • AMPK is suppressed in brain from ALD patients1 • ABCD2/3 could replace function of missing ABCD1; AMPK activation with metformin elevates ABCD2 levels in patient cell lines and ABCD1-KO mice1 • Deletion of AMPK𝛼1 in…
Slide 25: Potential for AMPK Activation to Treat Renal Diseases
5 Potential for AMPK Activation to Treat PXL770 Improves Kidney Function in UACR ZSF1D90 Rat Model of DKD Renal Diseases 80 ✱✱✱ ✱✱✱ Urine Albumin/Creatinine DKD GFR Diabetic Kidney Disease 60 ✱ 8 Lean mg/mg ***: p< 0.01 mg/mg ✱ • Multiple pathways engaged; anti-inflammatory, anti-apoptotic, p=0.09 Z
Slide 26: Upcoming Milestones
Upcoming Milestones 26
Slide 27: Cash Through Significant Upcoming Milestones in 2022
Cash Through Significant Upcoming Milestones in 2022 T2D NASH T2D NASH • Anticipated Imeglimin J-NDA approval; • Imeglimin & PXL770 triggers ~€14.2M ($16.6M)* and ability to presentations at EASD draw down EUR 13.5M from IPF loan • PXL770 Phase 2a Results • Imeglimin launch • PXL065 Ph 2 recruitment
Slide 28: Thank You
Thank You 28