9 Meters Biopharma, Inc. · OTC:NMTRQ
9 Meters Biopharma — Corporate Update (December 2020)
19 slides from 9 Meters Biopharma's corporate update, Dec 7, 2020
Slide 1: Positive Phase 1b/2a Topline Data in Short Bowel Syndrome
Positive Phase 1b/2a Topline Data in Short Bowel Syndrome -Rapid onset and sustained clinical effect following first dose in all 9 patients in total stool output (TSO) volume -Clinically relevant improvements in TSO volume and bowel movement frequency -Twice-monthly fixed-dosing regimen exhibited an
Slide 2: Forward Looking Statements
Forward Looking Statements This presentation includes forward-looking statements based upon the Company's current expectations. Forward-looking statements involve risks and uncertainties, and include, but are not limited to, the development and commercial potential and potential benefits of any prod
Slide 3: Short Bowel Syndrome Background & Current Paradigm
Short Bowel Syndrome Background & Current Paradigm
Slide 4: Short Bowel Syndrome (SBS) is a Debilitating Orphan Disease
4 1Jeppesen P. Expert Opin Orphan Drugs; 1:515-25; 2Transparency Market Research; Short Bowel Syndrome Market, 2019; 3Amiot A et al. Clin Nutr 2013;32:368–74; Boland E et al. Am J Surg 2010;200:690–3; 4Bielawska B. Nutrients 2017;9:466–79; Pironi L et al. Clin Nutr 2016;352:247–307; Hofstetter S et
Slide 5: Patients With SBS Typically Have No Natural GLP-1
5 Patients With SBS Typically Have No Natural GLP-1 • GLP-1 is naturally produced in a portion of ileum that is removed during surgical resection • Natural GLP-1 prevents the GI tract from moving rapidly: known as an “ileal brake” • Without this brake, there is a lack of gut motility, causing an SBS
Slide 6: SBS Patients' Perspectives on Living with the Disease
SBS Patients’ Perspectives on Living with the Disease 6 Patient quotes from NPS market research; Source: SEC 8-k April 2010 NPS Pharmaceuticals Inc. If you want a one-word description [of living with Short-Bowel Syndrome], it’s ’hell’. It changes your whole life, it ruins your life. There are ups an
Slide 7: NM-002: Long-Acting GLP-1 Agonist Phase 1b/2a Topline Results
NM-002: Long-Acting GLP-1 Agonist Phase 1b/2a Topline Results
Slide 8: Phase 1b/2a Study: SBS Clinical Trial Design
Phase 1b/2a Study: SBS Clinical Trial Design 8 Screening 50 mg cohort n = 2 100 mg Cohort n = 2 50 mg Cohort n = 1 100 mg Cohort n = 2 Total n=9 7 Day Safety Assessment 150 mg Cohort n = 1 150 mg Cohort N = 1 7 Day Safety Assessment 7 Day Safety Assessment Open label, two-dose, dose escalation study
Slide 9: Summary of Study Results
Summary of Study Results 9 Study met its primary objective: NM-002 demonstrated an excellent safety and tolerability profile NM-002 demonstrated a clinically relevant improvement in total stool output (TSO) volume, supporting a clear “GO” decision for next phase of development New data support twice
Slide 10: Phase 1b/2a Trial Demographics
Demographic 50 mg Cohort 100 mg Cohort 150 mg Cohort Overall Gender (m/f) 0/3 3/1 2/0 5/4 Avg. Age (y) 45.7 52.0 60.5 51.8 Race (White/Black) 3/0 3/1 2/0 8/1 Avg. Height (cm) 170.2 178.1 176.5 175.1 Avg. Weight (kg) 58.1 72.5 74.2 68.0 Avg. BMI (kg.m-2) 20.3 (14.2 to 27.0) 22.6 (20.8 to 24.8) 23.8 (
Slide 11: Phase 1b/2a Trial: Treatment Emergent Adverse Events
50 mg Cohort (n=3) 100 mg Cohort (n=4) 150 mg Cohort (n=2) Any exposure to NM-002 (n=9) System Organ Class Preferred Term # of subjects n (%) # of events n # of subjects n (%) # of events n # of subjects n (%) # of events n # of subjects n (%) # of events n TEAEs 3 (100.0) 7 3 (75.0) 6 2 (100.0) 4 8
Slide 12: Phase 1b/2a Efficacy: Total Stool Output (TSO)
Patient NM-002 Dose (mg) Baseline (mL) First 48 Hours Post Dose 1 (mL) Change from Baseline (mL) First 48 Hours Post Dose 2 (mL) Change from Baseline (mL) 1 50 22508 12550 −9958 13950 −8558 2 50 1900 200 −1700 300 −1600 61 50 1175 350 −825 - - 3 100 720 615 −105 325 −395 4 100 1285 420 -865 24502 11
Slide 13: Phase 1b/2a Efficacy Measure: Bowel Frequency
Patients 1 had an end jejunostomy and 3 had an ileostomy therefore missing from the bowel frequency table; stool output (previous slide) more relevant in these patients 13 Phase 1b/2a Efficacy Measure: Bowel Frequency Patient NM-002 Dose (mg) Baseline (#) First 48 Hours Post Dose 1 (#) Change from B
Slide 14: Preliminary Pharmacokinetic Analysis (n=7)
14 Day Parameter 50 mg Cohort (n=3) 100 mg Cohort (n=3)2 150 mg Cohort (n=1)3,4 1 Mean AUC0-t (h*ng/m L) 1481465.77 2941663.33 3087281.46 Mean Cmax (ng/mL) 13893.92 25502.68 26704.34 Mean Tmax (h) 144.00 144.00 168.00 Day Parameter 50 mg Cohort (n=2)1 100 mg Cohort (n=3)2 150 mg Cohort3,4 15 Mean AU
Slide 15: Summary of Study Results
Summary of Study Results 15 Study met its primary objective: NM-002 demonstrated an excellent safety and tolerability profile NM-002 demonstrated a clinically relevant improvement in total stool output (TSO) volume, supporting a clear “GO” decision for next phase of development New data support twic
Slide 16: Planned Regulatory Path
Planned Regulatory Path 16 Phase 3 4Q21 initiation Meeting with FDA to confirm go-forward strategy in 1Q21 -Type C meeting Approximately 20 patient Phase 2 program to start 2Q21 Phase 2 data expected 4Q21
Slide 17: NM-002: Potential Near Term Inflection Points
April/May - USAN Name Granted (April) - Digestive Disease Week (May) NM-002: Potential Near Term Inflection Points 17 1Q21 - 9 Meters SBS R & D Day - FDA meeting to confirm strategy 2Q21 Phase 2 initiation -20 patient trial starts 4Q21 Topline Phase 2 results 4Q21 Phase 3 SBS study initiation Decemb
Slide 18: NM-002 versus GLP-2 Class Profile
18 NM-002 (proprietary long-acting GLP-1)* GLP-2 Class Profile ü Long acting GLP-1 receptor agonist ü Slows gut motility ü Increases time for absorption of key nutrients – GLP-2 analogue – Expand intestinal mucosa / villous growth – Limited effect on gut motility Efficacy ü Improvements in total sto
Slide 19: Thank You
Thank You John Temperato President & CEO jtemperato@9meters.com Edward Sitar Chief Financial Officer esitar@9meters.com 8480 Honeycutt Road, Suite 120 Raleigh, NC 27615 Telephone: 1-919-275-1933 info@9meters.com www.9meters.com Twitter LinkedIn
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