Slide 1: Vogenx
Slide 2: Disclaimer
Disclaimer Vogenx, Inc. ("Vogenx" or the "Company") has filed a registration statement (including a preliminary prospectus) with the U.S. Securities and Exchange Commission (the "SEC") for the offering to which this communication relates. This presentation constitutes a "free writing prospectus" wit
Slide 3: Corporate Overview
Corporate Overview Founded in 2021; Based in Raleigh, North Carolina Post Bariatric Hypoglycemia (PBH) Series A Round, Q1 2022 Novel Phase 2 Oral Small Molecule Drug Candidate Metabolic & Gastrointestinal No drugs approved for PBH; Single approved option for gastroparesis Two successful Phase 2 read
Slide 4: Leadership & Scientific Advisors
Leadership & Scientific Advisors Outside Directors Tim Boris, Esq. General Counsel for Elucida Oncology Richard Gorman President, Strategic Consulting at Envision Pharma Group James Green, MBA Steve Delmar Peter Pieraccini CEO CFO Former CEO at ZenBio Scientific Advisors David D’Alessio, M.D. Tracey
Slide 5: Pipeline
Pipeline Program Indication Pre-Clinical Phase 1 Phase 2a Phase 2b Phase 3 Post Bariatric Hypoglycemia EMERGE Trial (PBH) Mizagliflozin Gastroparesis SGLT1 Inhibitor GIP-dependent Cushing’s Syndrome VGX-2857 Weight Maintenance 6
Slide 6: Mizagliflozin
Mizagliflozin Novel orally dosed small molecule inhibitor Target and Site of Action: SGLT1 in the intestinal lumen Mechanism of Action: Inhibition of glucose absorption and reductions in secretion of insulin and GIP 7
Slide 7: Mizagliflozin Overview
Mizagliflozin Overview Development Status • Phase 2b ready for PBH • Phase 2a ready for Gastroparesis • Pre-clinical package complete (including 2-year carcinogenicity in rats) Safety • Observed to be well tolerated in Phase 2 studies • No drug-related significant adverse events Efficacy • Significa
Slide 8: Post Bariatric Hypoglycemia (PBH)
Post Bariatric Hypoglycemia (PBH) Indication Summary • Chronic disorder related to bariatric surgery and characterized by reactive postprandial hyperinsulinemic hypoglycemia • Spectrum disease with varying levels of severity and frequency of events • Patients have above average rates of hospitalizat
Slide 9: Why Mizagliflozin – Competitive Advantage
Why Mizagliflozin – Competitive Advantage Reduce Reduce Product Drug Target Target Development Reduce Company Administration Glucose Insulin Candidate Substance Mechanism Distribution Status GIP Absorption Secretion Small Mizagliflozin SGLT1 Inhibitor GI Only Phase 2b Oral Molecule GLP-1 Amyly
Slide 10: Why Mizagliflozin – Competitive Advantage
Why Mizagliflozin – Competitive Advantage Safety & Tolerability • Other drugs in development focus only on downstream effects that can lead to postprandial hyperglycemia (pathway to diabetes) • Systemic injectable peptides with unknown long-term safety risks vs. mizagliflozin, a non-absorbable inhib
Slide 11: Post Bariatric Hypoglycemia – Glucose & Insulin
Post Bariatric Hypoglycemia – Glucose & Insulin • The ideal PBH treatment would delay and reduce postprandial absorption of glucose and GIP secretion, thereby reducing the uncontrolled spike in insulin secretion¹ • Therapeutics aimed only at reducing insulin secretion without a reduction in glucose
Slide 12: Mizagliflozin: Upstream of Insulin Secretion
Mizagliflozin: Upstream of Insulin Secretion PBH patients Increased SGLT1 transporter expression in gut lumen Miza inhibits glucose transport into the blood X Miza reduces Excessive GIP Excessive GLP-1 GIP production secretion by K cells secretion by L cells GLP-1 antagonists T acting downstream Hyp
Slide 13: Mizagliflozin for PBH Clinical Data
Mizagliflozin for PBH Clinical Data 14
Slide 14: Phase 2 Repeat Dose Study 012 for PBH
Phase 2 Repeat Dose Study 012 for PBH Study Objective: Confirm doses and regimen for Phase 2b Visit 1 Visit 2 Visit 3 Visit 4 Visit 5 Visit 6 Screening Repeat Dose MMTT Washout Repeat Dose MMTT Repeat Dose MMTT Follow Up (Day -14 to -1) (Day 1 to 9) (Day 9) (Day 10 to 17) (Day 18 to 27) (Day 28) (Da
Slide 15: % Reduction in Rate of Hypoglycemia
Phase 2 Repeat Dose Study 012 for PBH Exploratory Endpoint – Change in Hypoglycemic Events % Reduction in Rate of Hypoglycemia by 100 Mizagliflozin Dose 90 80 76% % Reduction in Rate of Hypoglycemia 67% 73% 70 * 62% 60% Study 012: Cross over study with 15 subjects; Blinded, 60 * * randomized, 7 day
Slide 16: Reduction Hypoglycemic Events / 7 Day
Phase 2 Repeat Dose Study 012 for PBH Exploratory Endpoint – Change in Hypoglycemic Events Reduction of Events Reduction of Events All Subjects Dosed with 5 mg or 10 mg 5 mg & 10 mg Subjects with Hypo Events on Placebo Reduction Hypoglycemic Events / 7 Day 0 0 -1 -1 Reduction of Events-7 Days -2 * -
Slide 17: Secondary Endpoint – Change in Insulin vs. Placebo
Phase 2 Repeat Dose Study 012 for PBH Secondary Endpoint – Change in Insulin vs. Placebo Insulin Over Time During MMTT 400 350 All Subjects dosed with 5 mg TID or 10 mg TID (n=6). Placebo averaged from both 5 mg TID and 10 mg TID 300 Only 5 mg TID subjects patients that went Insulin IU/dL 250 hypo
Slide 18: Secondary Endpoint – Peak Insulin
Phase 2 Repeat Dose Study 012 for PBH Secondary Endpoint – Peak Insulin Mizagliflozin Markedly Reduces Peak Insulin 0 -50 53% -100 64% Peak Insulin Mean Standard Dose p-value Change from Placebo Error 5 + 10 mg TID (hypo on Mizagliflozin (012) -253.2 (64%) 70.5 0.031 Peak Insulin IU/mL placebo only
Slide 19: Secondary Endpoint – Peak Glucose: Change from Placebo
Phase 2 Repeat Dose Study 012 for PBH Secondary Endpoint – Peak Glucose: Change from Placebo Glucose Over Time During MMTT 250 Only 5 mg TID 200 All Subjects dosed with either 5 mg TID or 10 mg TID (n=6). patients that went Placebo averaged from both 5 mg TID and 10 mg TID subjects. hypo on placebo
Slide 20: Primary Endpoint – Change in Glucose Nadir vs. PBO
Phase 2 Repeat Dose Study 012 for PBH Primary Endpoint – Change in Glucose Nadir vs. PBO Mizagliflozin Increases Glucose Nadir 30 25 p=0.031 Glucose Nadir Mean Standard Dose p-value Change from Placebo Error 20 5 + 10 mg TID (hypo on Mizagliflozin (012) 20 (56%) 5.0 0.031 placebo only) Glucose mg/dL
Slide 21: Mizagliflozin Reduces Glucose Peak
Phase 2 Repeat Dose Study 012 for PBH Secondary Endpoint – Peak Glucose: Change from Placebo Mizagliflozin Reduces Glucose Peak 40 20 0 Glucose Peak Mean Standard Dose p-value Change from Placebo Error 34% 31% Peak Glucose mg/dL 5 + 10 mg TID (hypo on Mizagliflozin (012) -73.2 (34%) 10.2 0.031 -20 p
Slide 22: Reductions in Postprandial Circulating GIP
Reductions in Postprandial Circulating GIP Reductions in GIP Across Patient Populations Subject Population Treatment GIP Reduction as % of Control Healthy Subjects 5 mg TID (14 day) 79.0% Type 2 Diabetics 5 mg BID (6 day) 59.0% PBH Patients 5 mg (single dose) 45.2% • Postprandial GIP secretion in th
Slide 23: Adverse Events
Phase 2 Repeat Dose Study 012 for PBH Adverse Events Placebo (N=15) 5 mg TID (N=6) 10 mg TID (N=3) Total Active (N=15) n (%) n (%) n (%) n (%) Subjects with any AEs 7 (46.7) 5 (83.3) 1 (33.3) 15 (100.0) Subjects with any TEAEs 7 (46.7) 5 (83.3) 1 (33.3) 15 (100.0) TEAEs by maximum intensity CTCAE gr
Slide 24: Mizagliflozin for PBH – Clinical Development Plan
Mizagliflozin for PBH – Clinical Development Plan Phase 2b – EMERGE Study • Multicenter, randomized, double-blind, placebo-controlled, repeat dose parallel group study • 21-day run in + 28-day treatment period • Primary Endpoint: Decrease composite of Level 3 and Level 2 hypoglycemic events (patient
Slide 25: Mizagliflozin for Gastroparesis
Mizagliflozin for Gastroparesis 26
Slide 26: Gastroparesis - Overview
Gastroparesis - Overview • Gastroparesis can be a chronic health problem with no effective long-term treatment • The cause of gastroparesis is generally unknown, but most commonly is a complication related to diabetes, certain surgeries and some medications (GLP-1 agonists) Gastroparesis (Delayed Ga
Slide 27: Mizagliflozin for Gastroparesis - Rationale
Mizagliflozin for Gastroparesis - Rationale Gastroparesis is associated with • Elevated fasting and post-prandial GIP concentrations1 • Acute postprandial hyperglycemia slows gastric emptying2 • Reduced GI transit time and higher rates of slow transit constipation3 • Mizagliflozin has been shown to
Slide 28: Reductions in Postprandial Plasma Glucose & Effective in Chronic Constipation
Mizagliflozin for Gastroparesis Reductions in Postprandial Plasma Glucose & Effective in Chronic Constipation Mizagliflozin relieves constipation and hydrates the GI tract Healthy Human Subjects PBH Patients 29
Slide 29: Phase 2 POC Study Design for Gastroparesis
Mizagliflozin for Gastroparesis Phase 2 POC Study Design • Randomized, parallel group, double-blind, placebo- controlled study comparing different doses of mizagliflozin on gastric emptying time in patients with gastroparesis • 28-day run-in + 28-day treatment period • Primary endpoint: Change from
Slide 30: Gastroparesis – Competitive Landscape
Gastroparesis – Competitive Landscape Products used off-label with varying levels of success: Approved Company Product Rationale Mechanism Indication Competitive Landscape Oligo-peptide Abbvie Linaclotide Constipation GI Tract Hydration Single FDA approved product (generic) agonist CIC-2 chloride •
Slide 31: Vogenx
Vogenx