9 Meters Biopharma, Inc. · OTC:NMTRQ
9 Meters Biopharma — Investor Presentation (August 2020)
25 slides from 9 Meters Biopharma's investor presentation, August 2020
Slide 1: A New Champion in GI
A New 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 potential effects of the ongoing coronavirus outbreak and related mitig
Slide 3: Investment Highlights
Investment Highlights NASDAQ listed NM-002 Larazotide Focused on Leading (NMTR) Our proprietary First drug to move increasing institutional focused on rare, long-acting GLP-1 into a Phase 3 trial shareholder investor support orphan and unmet agonist for short in celiac disease value by creating need
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: Pipeline Led by Short Bowel Syndrome & Celiac Disease
Pipeline Led by Short Bowel Syndrome & Celiac Disease 6
Slide 7: Multiple Inflection Points Over Next 24 Months
Multiple Inflection Points Over Next 24 Months 1H 2020 2H 2020 1H 2021 2H 2021 ü Initiate Phase 1b/2a SBS • Top-line results Phase • Start Phase 3 SBS ü 9 Meters Biopharma, Inc. Study (NM-002) 1b/2a SBS (NM-002) Study (NM-002) Nasdaq listed (NMTR) and now fully integrated ü Initiate monetization of
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 Normal SBS Patient Length of GI Tract Length of GI Tract Orphan disease (orphan designation granted) ~ 9.0 m /~ 30 ft Significantly Shortened with an underserved market Affects up to 20,000 people in the U.S. with similar prevalence in Euro
Slide 10: New Approach to SBS with Long-Acting GLP-1 Agonist
New Approach to SBS with Long-Acting GLP-1 Agonist Long Acting GLP-1 (exenatide) for SBS • Different from GLP-1s used for glycemic effects in T2DM • Mechanism involves gastric motility in SBS patients • Dosing twice monthly; potentially monthly • Potentially improves therapeutic index of GLP-1 mecha
Slide 11: Key Advantages of NM-002 in Short Bowel Syndrome
Key Advantages of NM-002 in Short Bowel Syndrome Put limitations of Gattex here Limitations of GLP-2 Analogues Long-acting GLP-1 agonist (NM-002) Frequency Daily injection to once/twice-weekly forms Fewer doses than current approach of Dose Known target - potential improved REMS: Trophic/Growth fa
Slide 12: NM-002 GI Safety in Patients with Diabetes (Ph1 Single-Dose)
NM-002 GI Safety in Patients with Diabetes (Ph1 Single-Dose) Gastrointestinal Side Effect 12.5 mg 25 mg 50 mg 100 mg 150 mg 200 mg PBO Overall Reported (n=8) (n=10) (n=9) (n=8) (n=9) (n=8) (n=18) (n=70) Nausea 0 1 (10%) 1 (11%) 2 (25%) 8 (89%) 5 (63%) 2 (11%) 19 (27%) Dyspepsia 0 0 0 1 (13%) 1 (11%)
Slide 13: Proof-of-Concept of Exenatide (GLP-1 agonist) in SBS Patients
Proof-of-Concept of Exenatide (GLP-1 agonist) in SBS Patients • Five patients with SBS based on <90 cm of small bowel and clinical evidence of nutritional deprivation selected • Each patient started on 5µg dose of exenatide BID and continued over the following month, baseline parameters repeated • A
Slide 14: Phase 1b/2a SBS Clinical Study Design
Phase 1b/2a SBS Clinical Study Design 7 Day Safety 7 Day Safety 7 Day Safety Assessment Assessment Assessment Dose 1 Cohort Dose 2 Cohort n = 1 to 2 n = 1 to 2 Dose 1 Cohort Total n~12 Screening n=2 Dose 2 Cohort n=2 Dose 3 Cohort Dose 3 Cohort n=2 N = 1 to 2 Study Details & Objectives: • Single-cen
Slide 15: Comparable Deals/Companies in SBS
Comparable Deals/Companies in SBS October 2015 May 2019 August 2017 Acquires for $340 million upfront+ $470 Approved for SBS in 2012 million CVRs (2019); GLP-2 asset for Raised $78 million by August 2017 SBS in spin-off (VectivBio) Acquired NPS for $5.2 Billion Acquires post $60 million mezzanine Cu
Slide 16: Larazotide: Oral, Non-Absorbable Tight-Junction Regulator
Larazotide: Oral, Non-Absorbable Tight-Junction Regulator Celiac Disease
Slide 17: 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 18: Larazotide Normalizes Intestinal Barrier in Celiac Disease
Larazotide Normalizes Intestinal Barrier in Celiac Disease 18
Slide 19: Key Advantages: Our Approach to Celiac Disease
Key Advantages: Our Approach to Celiac Disease Gluten-Free Diet (GFD) is the only option Larazotide Non-adherence is a common as diet is Novel peptide tight-junction regulator; Mechanism restrictive and difficult-to-follow1 oral administration Inadvertent exposure: gluten in lip-balms, Safety Gut-re
Slide 20: 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 21: GI Safety of Larazotide in Celiac Patients (Phase 2b Study)
GI Safety of Larazotide in Celiac Patients (Phase 2b Study) Gastrointestinal Side Effect Reported PBO (n=84) 0.5 mg (n=85) 1 mg (n=84) 2 mg (n=87) Overall (n=256) Diarrhea 7 (8.3%) 7 (8.2%) 5 (6.0%) 8 (9.2%) 20 (7.8%) Nausea 9 (10.7%) 4 (4.7%) 7 (8.3%) 7 (8.0%) 18 (7.0%) Constipation 2 (2.4%) 3 (3.5
Slide 22: Phase 3 Primary Endpoint: CeD PRO Validated in Phase 2b
Phase 3 Primary Endpoint: CeD PRO Validated in Phase 2b The CeD PRO was pre-specified and an exploratory endpoint in the Phase 2b Study Thinking about your worst experience in the past 24 hours, how severe was each of the following symptoms? On the following screens, please tap a number to indicate
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 Milestones
Timeline & Upcoming Milestones 1H 2020 1H 2020 2H 2020 1H 2021 1H 2021 2H 2021 9 Meters Biopharma, Inc. 9 Meters Hosts Lead indication Top-line results Initiate RoW Start Phase 3 SBS Nasdaq listed (NMTR) and Research & selection of GLP-2 Phase 1b/2a SBS partnering Study (NM-002) now fully integrated
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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