9 Meters Biopharma, Inc. · OTC:NMTRQ
9 Meters Biopharma — Investor Presentation (December 2020)
25 slides from 9 Meters Biopharma's investor presentation, December 2020
Slide 1: A Champion in GI
A Champion in GI With A One Tract Mind Focused on Rare and Unmet Needs in Gastroenterology
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: Investment Highlights
Investment Highlights NASDAQ listed NM-002 Larazotide Focused on Leading (NMTR) Proprietary First drug to move increasing institutional focused on rare, long-acting GLP-1 into a Phase 3 trial shareholder investor support and unmet needs agonist for short in celiac disease value by creating in gastro
Slide 4: Leadership Team
Leadership Team John Temperato President & CEO Edward Sitar Chief Financial Officer Patrick Griffin, MD Chief Medical Officer Sireesh Appajosyula, SVP, Corporate Development PharmD & Operations Nir Barak, MD SVP, Clinical Affairs 4
Slide 5: 9 Meters in Circuitous Length - But a Straight-Forward Strategy
9 Meters in Circuitous Length - But a Straight-Forward Strategy GI-Centric, Patient-Focused Develop Acquire / Acquire targeted clinical compounds capital efficient Partner Agnostic within GI tract if needs are unmet + regulatory aligned to focus Rare & unmet needs allows for predicates targete
Slide 6: 9 Meters Pipeline in Rare and Unmet Need GI Diseases
9 Meters Pipeline in Rare and Unmet Need GI Diseases PROGRAM INDICATION CLASS ROUTE PRE-CLINICAL PHASE 1 PHASE 2 PHASE 3 UPCOMING MILESTONES Larazotide Tight Junction Regulator Oral; Gut Restricted Topline readout Adult Celiac Disease Phase 3 → 2H21 NM-002 Long-Acting GLP-1 Injectable Initiate Phase
Slide 7: Multiple Potential Inflection Points Over Next 12 Months
Multiple Potential Inflection Points Over Next 12 Months 1Q 2021 2Q 2021 3Q 2021 4Q 2021 • Short bowel syndrome • Initiate Phase 2 NM-002 • Initiate IND-enabling • Topline Phase 2 R & D Day trial pathway for NM-102 readout of NM-002 • Planned FDA meeting trial • Interim analysis: Phase • Initiate IN
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
Short Bowel Syndrome (SBS) is a Debilitating Orphan Disease • Orphan disease (orphan designation granted) and an underserved market Normal SBS Patient • Affects up to 20,000 people in the US with similar prevalence in Length of GI Tract Length of GI Tract EU1,2 ~ 9.0 m / ~ 30 ft Significantly Shorte
Slide 10: Patients With SBS Typically Have No Natural GLP-1
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 p
Slide 11: SBS Patients' Perspectives on Living with the Disease
SBS Patients’ Perspectives on Living with the Disease The bathroom is probably the most If you want a one-word description [of I’m going so much I have no annoying thing… I always have plastic living with Short-Bowel Syndrome], life. I can’t go anywhere – bags with me and because my bag will fill it
Slide 12: NM-002 Target Product Profile
NM-002 Target Product Profile NM-002 (proprietary long-acting GLP-1)* GLP-2 Class Profile ü Long acting GLP-1 receptor agonist – GLP-2 analogue ü Slows gut motility – Expand intestinal mucosa / villous growth ü Increases time for absorption of key nutrients – Limited effect on gut motility Efficacy
Slide 13: Our Approach Replaces GLP-1 and Restores the "Ileal Brake"
Our Approach Replaces GLP-1 and Restores the “Ileal Brake” Long Acting GLP-1 (NM-002) for SBS With GLP-1, food passes more • Fundamentally different approach than GLP-2 slowly, allowing class mechanism that expands intestinal more nutrient uptake in a shorted mucosa / villous growth with little effe
Slide 14: Phase 1b/2a Study: SBS Clinical Trial Design
Phase 1b/2a Study: SBS Clinical Trial Design Open label, two-dose, dose escalation study of NM-002 in adult patients with SBS Key secondary outcomes: NM-002 given twice, Doses were Main outcomes: Patients followed for 6 Total stool output(TSO); at 3 different dose administered on Safety & weeks afte
Slide 15: Phase 1b/2a Trial: Treatment Emergent Adverse Events
Phase 1b/2a Trial: Treatment Emergent Adverse Events 50 mg Cohort 100 mg Cohort 150 mg Cohort Any exposure to NM-002 (n=3) (n=4) (n=2) (n=9) # of System Organ Class Preferred # of subjects # of events # of subjects # of events # of subjects # of events # of events subjects Term n (%) n n (%) n n (%)
Slide 16: Phase 1b/2a Efficacy: Total Stool Output (TSO)
Phase 1b/2a Efficacy: Total Stool Output (TSO) NM-002 Dose First 48 Hours Change from First 48 Hours Change from Patient Baseline (mL) (mg) Post Dose 1 (mL) Baseline (mL) Post Dose 2 (mL) Baseline (mL) 1 50 22508 12550 −9958 13950 −8558 2 50 1900 200 −1700 300 −1600 61 50 1175 350 −825 - - 3 100 720
Slide 17: Summary of Study Results
Summary of Study Results 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 m
Slide 18: Planned Regulatory Path
Planned Regulatory Path 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 Phase 3 initiation 4Q21 18
Slide 19: Larazotide: Oral, Non-Absorbable Tight-Junction Regulator
Larazotide: Oral, Non-Absorbable Tight-Junction Regulator Celiac Disease
Slide 20: Celiac Disease: Autoimmune Disorder with a Genetic Link
Celiac Disease: Autoimmune Disorder with a Genetic Link Triggered by dietary gluten • Intestinal epithelia barrier leakiness leads to “Intestinal- Inflammatory Loop” • Eventually, intestinal surface (villi) become atrophied Genetic link • Worldwide prevalence of around 1% and on the rise1 ‒ Celiac p
Slide 21: Larazotide Normalizes Intestinal Barrier in Celiac Disease
Larazotide Normalizes Intestinal Barrier in Celiac Disease 21
Slide 22: Phase 2: PRO Endpoints Show Robust Treatment Effect
Phase 2: PRO Endpoints Show Robust Treatment Effect CeD-GSRS: CeD PRO1 Responder2 Analysis P2b Trial Primary Endpoint for Phase 2b (‘012) Primary Endpoint for Phase 3 30.0% p = 0.022 28.6% 20.0% 14.3% % Responders* Treatment Effect 14.3% 10.0% 0.0% Placebo 0.50mg Dose 0.5mg 1mg 2mg n=84 for Placebo
Slide 23: Phase 3 Trial Design in Celiac Disease (n = 525)
Phase 3 Trial Design in Celiac Disease (n = 525) 12-week Double-Blind Treatment Phase Screening/Eligibility Period 12-week Double-Blind Safety Phase Primary Endpoint Analyzed at Week 12 Day 35 Day 21 Day 1 Day 28 ± 3 Day 56 ± 3 Day 84 ± 3 Day 112 ± 3 Day 168 ± 3 Week 5 Week 3 Baseline Week 4 Week 8
Slide 24: Timeline & Upcoming Potential Milestones
Timeline & Upcoming Potential Milestones 1Q 2021 2Q 2021 3Q 2021 Q4 2021 Short bowel syndrome Initiate Phase 2 NM-002 Initiate IND-enabling Topline Phase 2 readout R & D Day trial in SBS pathway for NM-102 of NM-002 SBS trial Planned FDA meeting to Interim analysis of Initiate IND-enabling Initiate
Slide 25: 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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