9 Meters Biopharma, Inc. · OTC:NMTRQ
9 Meters Biopharma — Investor Presentation (March 2021)
26 slides from 9 Meters Biopharma's investor presentation, Mar 23, 2021
Slide 1: A Champion in GI With A One Tract Mind
A Champion in GI With A One Tract Mind Focused on Rare and Unmet Needs in Gastroenterology Corporate Presentation
Slide 2: Forward Looking Statements
Forward Looking Statements 2 This press release includes forward-looking statements based upon the Company's current expectations. Forward-looking statements include, but are not limited to, statements that express our intentions, beliefs, expectations, strategies, predictions or any other statement
Slide 3: Investment Highlights
Investment Highlights 3 NASDAQ listed (NMTR) focused on rare, and unmet needs in gastrointestinal disorders NM-002 Proprietary long-acting GLP-1 agonist for short bowel syndrome, with positive phase 1b/2a data with a phase 2 readout in 2021 Larazotide First drug to move into a Phase 3 trial in celia
Slide 4: Leadership Team
Leadership Team 4 John Temperato President & CEO Edward Sitar Chief Financial Officer Patrick Griffin, MD Chief Medical Officer Sireesh Appajosyula, PharmD SVP, Corporate Development & Operations Nir Barak, MD SVP, Clinical Affairs
Slide 5: 9 Meters in Circuitous Length - But a Straight-Forward Strategy
Capital efficient development pathway Market protection enhancements Capital efficient commercialization Payer leverage Acquire targeted clinical compounds Agnostic within GI tract if needs are unmet Rare & unmet needs allows for targeted patient profiling within GI 9 Meters in Circuit
Slide 6: 9 Meters Pipeline in Rare and Unmet Need GI Diseases
9 Meters Pipeline in Rare and Unmet Need GI Diseases 6 NOTE: All programs are New Chemical Entities. NOTE: All programs are globally licensed except NM-004, which excludes Asia, except for Japan. PROGRAM INDICATION CLASS ROUTE PRE-CLINICAL PHASE 1 PHASE 2 PHASE 3 UPCOMING MILESTONES Topline readout
Slide 7: Multiple Potential Inflection Points Over Next 12-18 Months
Multiple Potential Inflection Points Over Next 12-18 Months 7 • Initiate Phase 2 NM-002 trial • Obtain USAN name for NM-002 • Attendance at Digestive Disease Week (DDW) conference 2Q 2021 • Initiate IND-enabling pathway for NM-102 • Initiate IND-enabling pathway for NM-003 3Q 2021 • Topline Phase 2
Slide 8: NM-002: Long-Acting GLP-1 Agonist
NM-002: Long-Acting GLP-1 Agonist Short Bowel Syndrome (SBS); Orphan designation
Slide 9: Short Bowel Syndrome (SBS) is a Debilitating Orphan Disease
9 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 10: Patients With SBS Typically Have No Natural GLP-1
10 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 SB
Slide 11: SBS Patient Perspective on Chronic Diarrhea
SBS Patient Perspective on Chronic Diarrhea Indicative of Significant Impact Over the Last Decade 11 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 who
Slide 12: NM-002 vs GLP-2 Class Profile
12 NM-002 (proprietary long-acting GLP-1)* GLP-2 Class Profile Long acting GLP-1 receptor agonist Slows gut motility Increases time for absorption of key nutrients – GLP-2 analogue – Expand intestinal mucosa / villous growth – Limited effect on gut motility Efficacy Improvements in total sto
Slide 13: NM-002 Replaces GLP-1 and Restores the Ileal Brake
In a shortened bowel, motility is increased, reducing nutrient uptake and causing quicker movement of food through the bowel. Typical Short Bowel Syndrome Short Bowel Syndrome with GLP-1 GLP-1 travels through the blood, which affects gut motility elsewhere in the body. Motility is slowed, allowing m
Slide 14: Phase 1b/2a Study: SBS Clinical Trial Design
Phase 1b/2a Study: SBS Clinical Trial Design 14 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 stud
Slide 15: 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 16: Phase 1b/2a Efficacy: Total Stool Output
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 17: Summary of Study Results
Summary of Study Results 17 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 Data support twice mo
Slide 18: FDA Response on Planned Phase Program
FDA Response on Planned Phase 2 Program 18 Secondary endpoints will include parenteral requirements, diarrhea impact, meal-related stool output, nocturnal stool output, sleep quality and quality of life FDA Type C meeting communication supports plan to initiate Phase 2 study with NM-002 for SBS usin
Slide 19: Proposed NM-002 Study Design & Timeline
Proposed NM-002 Study Design & Timeline 19 Group n Treatment Day 0 7 14 21 28 1 6 50 mg PBO 50 mg PBO 50 mg 2 6 100 mg PBO 100 mg PBO 100 mg 3 6 50 mg 50 mg 50 mg 50 mg 50 mg 4 4 PBO PBO PBO PBO PBO • Study population: all comers (regardless of phenotype and/or PS requirement) • Site selection final
Slide 20: Larazotide: Oral, Non-Absorbable Tight-Junction Regulator
Larazotide: Oral, Non-Absorbable Tight-Junction Regulator Celiac Disease
Slide 21: Celiac Disease: Autoimmune Disorder with a Genetic Link
Celiac Disease: Autoimmune Disorder with a Genetic Link 21 1 Schuppan and Dieterich, UpTo Date (2018) 2 Fasano, A. Genetics of Celiac Disease (Nov 2019) https://emedicine.medscape.com/article/1790189-overview 3 Withoff, S., Li, Y., Jonkers, I. and Wijmenga, C., 2016. Trends in Genetics, 32(5), pp.29
Slide 22: Larazotide Normalizes Intestinal Barrier in Celiac Disease
Larazotide Normalizes Intestinal Barrier in Celiac Disease 22
Slide 23: Phase 2: PRO Endpoints Show Robust Treatment Effect
Phase 2: PRO Endpoints Show Robust Treatment Effect 23 1CeD PRO Abdominal Domain is the agreed upon endpoint for phase 3 with the FDA. The CeD PRO was pre-specified & an exploratory endpoint in the Phase 2b Study 2Responder ≈Subject has 50% improvement vs. baseline CeD-PRO abdominal score (6/12 week
Slide 24: Phase 3 Trial Design in Celiac Disease
Screening/Eligibility Period 12-week Double-Blind Treatment Phase Primary Endpoint Analyzed at Week 12 12-week Double-Blind Safety Phase Phase 3 Trial Design in Celiac Disease (n = 525) 24 1 Primary Endpoint: CeD Pro Abdominal Domain1 at 12 Weeks Mean change from baseline for celiac disease symptom
Slide 25: Near Term Inflection Points
April Obtain NM-002 USAN name Near Term Inflection Points 25 March 23 9 Meters SBS R & D Day -Full data set review 2020 2021 2Q21 Phase 2 initiation -22 patient trial starts 4Q21 Topline NM-002 Phase 2 results American College of Gastroenterology (ACG) conference 2022 Interim analysis for larazotide
Slide 26: 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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