Metavia Inc. · NASDAQ:MTVA
Metavia — NeuroBo Pharmaceuticals — IPO Roadshow (October 2022)
30 slides from Metavia's IPO roadshow presentation, Oct 24, 2022
Slide 1: NeuroBo Pharmaceuticals, Inc. Issuer Free Writing Prospectus
NeuroBo Pharmaceuticals, Inc. NASDAQ:NRBO October 2022 Issuer Free Writing Prospectus Filed Pursuant to Rule 433 Registration Statement No. 333 - 267482 October 24, 2022
Slide 2: Forward Looking Statements
2 Forward Looking Statements NeuroBo Pharmaceuticals, Inc. (“NeuroBo”) is offering shares of common stock, shares of convertible preferred stock and warra nts to purchase shares of common stock (the “Securities”) in a public offering (the “Offering”). The proceeds of the Offering are intended primar
Slide 3: Free Writing Prospectus
3 Free Writing Prospectus This presentation highlights basic information about us and the Offering. Because it is a summary, it does not contain all of th e information that you should consider before investing. We have filed a registration statement on Form S - 1 (File No. 333 - 267482) with the SE
Slide 4: Company Overview
4 Company Overview NeuroBo has entered into an agreement to in - license from Dong - A ST Co., Ltd (KOSE:A170900) two cardiometabolic assets for the treatment of nonalcoholic steatohepatitis (NASH), obesity and type 2 diabetes (T2DM). NRBO’s 2 nd Largest Shareholder (10.8% common stock ownership) 1.
Slide 5: License Agreement with Dong-A
5 License Agreement with Dong - A Terms of the licensing agreement with Dong - A include: Dong - A and NRBO Equity Upfront Payment for Licensing Agreement $22M ▪ Series A Convertible Preferred Stock. ▪ Conversion price = public offering price units. ▪ Conversion subject to shareholder vote. Private
Slide 6: Pipeline and Near-Term Catalysts
6 Pipeline and Near - Term Catalysts Product Preclinical Phase I Phase II Global Rights Upcoming Catalysts DA - 1241 (1) (GPR119 Agonist) 2H 2023: Interim NASH/T2DM data readout Mid 2024: Phase IIa NASH/T2DM data (Ex. Korea) DA - 1726 (GLP1R/GCGR Dual Agonist) (Ex. Korea) 2H 2023: Phase Ia Obesity/N
Slide 7: Anticipated Catalysts 2023-2024
7 2023 2024 1H 2023 Initiate Phase IIa study in NASH/T2DM 2H 2023 Phase Ia SAD data readout Anticipated Catalysts Q1 2023 File IND 2 H 2023 Initiate Phase Ib MAD study 2 H 2024 Phase Ib MAD data readout Mid 2023 Initiate Phase Ia SAD Study MID 2024 Phase IIa data readout in NASH/T2DM 2 H 2023 Interi
Slide 8: DA-1241
DA - 1241 1. DA - 1241 also has potential in T2DM. A novel G - Protein - Coupled Receptor 119 (GPR119) agonist with potential for Non - Alcoholic Steatohepatitis (NASH) (1) Synthetic, small molecule, selective and suitable for oral administration
Slide 9: DA-1241 Mechanism of Action in NASH
9 DA - 1241 Mechanism of Action in NASH DA - 1241 has a multimodal mechanism that induces strong anti - NASH effects, supported by potential best - in - class efficacy demonstrated during preclinical studies (1 - 5) ▪ Agonism of GPR119 in the gut promotes the release of key gut peptides GLP - 1, GIP
Slide 10: DA-1241 Attenuates NASH Progression in Obese NASH Mice
10 DA - 1241 Attenuates NASH Progression in Obese NASH Mice (1,2) ▪ Chronic treatment with DA - 1241 increased plasma total GLP - 1 , but NOT another GPR119 agonist ▪ DA - 1241 alleviated the progression of NASH in Ob - NASH mice on a high fat/fructose/CHO diet ▪ Biomarkers including CCL2 and TIMP -
Slide 11: Therapeutic Potential of DA-1241 in Diet Induced Obesity-NASH Mice
11 Therapeutic Potential of DA - 1241 in Diet Induced Obesity - NASH Mice (1 - 3) ▪ The beneficial effects of DA - 1241 alone and in combination with a DPP4 inhibitor were carried over to NASH models in mice ▪ DA - 1241 alone and in combination with a DPP4 inhibitor reduced hepatic lipid and collage
Slide 12: DA-1241 Clinical Trials to Date – Phase Ia and Ib
12 DA - 1241 Clinical Trials to Date – Phase Ia and Ib (1 - 4) Clinical Outcomes Study ▪ Phase Ia, First - In - Human, Double - Blind, Placebo - Controlled, Randomized, Single Ascending Dose and Interactions with Metformin Study (n=60) ▪ Phase Ib, Double - Blind, Placebo - Controlled, Randomized, Mu
Slide 13: DA-1241 NASH Upcoming Study Overview
13 DA - 1241 NASH Upcoming Study Overview Phase II to Establish Signal Efficacy in NASH Notes: NASH (Non - Alcoholic Steatohepatitis); NAFLD (Non - Alcoholic Fatty Liver Disease); T2DM (Type 2 Diabetes Mellitus); FPFV (First Patient First Visit); LPLV (Last Patient Last Visit). Phase II (NASH) Study
Slide 14: Novel oxyntomodulin analogue GLP1R/GCGR dual agonist
DA - 1726 A novel oxyntomodulin analogue functioning as a GLP1R/GCGR dual agonist for the treatment of NASH and obesity Once - weekly administration
Slide 15: Mechanism of Action
15 DA - 1726 Mechanism of Action DA - 1726 is a novel oxyntomodulin analogue functioning as a GLP1R/GCGR dual agonist for the treatment of obesity, NASH and possibly T2DM ▪ OXM is a peptide hormone released from the gut after a meal activating both the GLP - 1 and glucagon receptors ▪ In turn, reduc
Slide 16: Mechanism of Action of Body Weight Loss
16 16 5 7 9 11 13 15 17 19 21 6 12 18 24 30 36 42 48 54 60 66 72 Energy Expenditure (kcal/kg/hr) Time (hours) HF Control Pair-Fed DA-1726*# Mechanism of Action of Body Weight Loss (1,2) ▪ DA - 1726 was superior to the pair - fed group in the body weight loss, indicating that nearly half of the weigh
Slide 17: Therapeutic Potential Obesity
17 17 DA - 1726 Therapeutic Potential Obesity (1 - 3) DA - 1726 out - performed semaglutide (WEGOVY Ð ), a GLP - 1 agonist, in mouse models of obesity and T2DM BWL in HF - DIO Obese Mice DA - 1726 vs Semaglutide (1,3) Notes: GLP1R/GCGR (Glucagon - Like Peptide 1 Receptor/ Glucagon Receptor); HF - DI
Slide 18: Therapeutic Potential for NASH
18 18 6.75 5 * 3.88 * 3.63 * 0 1 2 3 4 5 6 7 NASH Control Semaglutide 250 nmol/kg* DA-1726 100 nmol/kg* DA-1726 200 nmol/kg* Score DA - 1726 Therapeutic Potential for NASH (1,2) DA - 1726 further improved hepatic steatosis, inflammation, and fibrosis compared to semaglutide Steatosis & Inflammation
Slide 19: Therapeutic Potential for NASH (Cont'd)
19 19 DA - 1726 Therapeutic Potential for NASH (Cont’d) (1,2) DA - 1726 reduced body weight and decreased plasma clinical chemistry parameters as well as decreased gene expression related to inflammation and liver fibrosis, with the low - dose group showing higher anti - NASH effects despite lower b
Slide 20: Obesity & NASH Upcoming Study Overviews
20 DA - 1726 Obesity & NASH Upcoming Study Overviews Notes: NASH (Non - Alcoholic Steatohepatitis); MAD (Multiple Ascending Dose); SAD (Single Ascending Dose); PK (Pharmacokinetic); P D (Pharmacodynamic); FPFV (First Patient First Visit); LPLV (Last Patient Last Visit). Phase I Population: ▪ Healthy
Slide 21: Market Opportunity & Financial Overview
Market Opportunity & Financial Overview
Slide 22: Developing Assets Targeting Significant Opportunities of Unmet Need
22 Developing Assets Targeting Significant Opportunities of Unmet Need… Source: Health Advances Quantitative Research Notes: GLP1R/GCGR (Glucagon - Like Peptide 1 Receptor/ Glucagon Receptor); NASH (Non - Alcoholic Steatohepatitis); Obesity It is estimated ~40% of patients on pharmacotherapy will re
Slide 23: Product Differentiation
23 Product Differentiation DA - 1726 ▪ Unlike semaglutide , the dual GLP1R /GCGR activity of DA - 1726 provides the added benefit of increased energy expenditure and a direct effect on the liver and steatosis • Demonstrated increased benefit compared to semaglutide on hepatic steatosis, fibrogenesis
Slide 24: WEGOVY (Semaglutide) and Obesity
24 24 WEGOVY Ð (Semaglutide) and Obesity In June 2021 the FDA approved WEGOVY Ð (semaglutide) injection for chronic weight management in adults with obesity or overweight with at least one weight - related conditions (e.g. high blood pressure, T2DM, or high cholesterol). 1. Novo Nordisk A/S Form 20
Slide 25: Tangible Universe of Successful, Early-Stage Cardio-Metabolic Comparables
25 25 Lead Product Pemvidutide DA - 1726 Indication Obesity/NASH Obesity/NASH Stage Phase II Pre - IND PoC Data x TBD Tangible Universe of Successful, Early - Stage Cardio - Metabolic Comparables Sources: Company Website, Press Releases, Corporate Presentation, Capital IQ as of 10/21/22 Notes: Inclu
Slide 26: Financials and Capitalization Table
26 Financials and Capitalization Table Capitalization as of September 30, 2022 Common Stock Equivalents Common Stock 888,693 Warrants ( WAEP $140.07) (1) 228,235 Options ( WAEP $99.62) 36,493 Fully Diluted 1,153,415 Other Potential Dilutive Securities Series A Convertible Preferred Issuance to Dong
Slide 27: The NeuroBo Team
27 The NeuroBo Team Scientific Advisory Board Roy Freeman, MBChB ▪ Prof. of Neurology, Harvard Medical School ▪ Director, Center for Autonomic and Peripheral Nerve Disorders ▪ Boston, MA Leigh Perreault, MD, FACE, FACP ▪ Associate Prof. of Medicine, Division of Endocrinology, Metabolism and Diabetes
Slide 28: Intellectual Property Rights
28 Intellectual Property Rights • IP rights currently owned by Dong - A and to be licensed to NeuroBo. DA - 1241 DA - 1726 US ▪ One patent: both composition of matter and process of making the composition. - E xpected to expire in 2035 * ▪ O ne non - provisional patent application: both composition
Slide 29: Business Development Opportunities
29 Business Development Opportunities Legacy Assets (1) ANA001 ▪ A proprietary oral niclosamide formulation being developed as a treatment for patients with moderate COVID - 19. ▪ Enrollment in the Phase 2 clinical trial for moderate COVID - 19 in hospitalized patients closed in July 2022 and the cl
Slide 30: NeuroBo Pharmaceuticals, Inc. Contact
NeuroBo Pharmaceuticals, Inc. NASDAQ:NRBO Contact: Frank Kondrad Vice President, Corporate and Business Development (610) 316 - 1735 Frank.Kondrad@NeuroBoPharma.com
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