9 Meters Biopharma, Inc. · OTC:NMTRQ
9 Meters Biopharma — Investor Presentation (July 2021)
30 slides from 9 Meters Biopharma's investor presentation, Jul 26, 2021
Slide 1: Pioneering Novel Treatments with a one-tract mind
Pioneering Novel Treatments with a one-tract mind FOCUSED ON RARE AND UNMET NEEDS IN DIGESTIVE DISEASES AND UNIQUE GI BIOLOGY
Slide 2: Forward-looking statements
forward-looking statements This 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 statements relating to ou
Slide 3: Vision and mission
Changing the world through novel therapeutic approaches that treat people with rare and debilitating conditions via unique gut related pathways. vision changing the world for patients mission Developing innovative treatments to liberate patients from rare and underserved diseases through our deep un
Slide 4: Investor highlights: 9 Meters at a glance
investor highlights 9 meters at a glance Focused on rare and unmet needs in digestive diseases and untapped GI biology vurolenatide Proprietary long-acting GLP-1 agonist for short bowel syndrome, with positive phase 1b/2a data and a Phase 2 readout in 2021 larazotide First drug to move into a Phase
Slide 5: Leadership team
leadership team John Temperato PRESIDENT & CHIEF EXECUTIVE OFFICER Edward Sitar CHIEF FINANCIAL OFFICER Patrick H. Griffin, MD CHIEF MEDICAL OFFICER Sireesh Appajosyula, PharmD SVP, CORPORATE DEVELOPMENT & OPERATIONS Nir Barak, MD SVP, CLINICAL AFFAIRS Matthew D. Bryant, PharmD VP, MEDICAL AFFAIRS 5
Slide 6: A straight-forward strategy
develop capital efficient & regulatory predicates acquire/ partner aligned to focus commercialize efficient US footprint; strategic ROW partnerships rare, unmet needs & unique GI biology digestive disease-centric, patient- focused • Acquire targeted clinical compounds • Agnostic within GI tract if n
Slide 7: Pipeline programs
NOTE: All programs are New Chemical Entities. NOTE: All programs are globally licensed except NM-004, which excludes Asia, except for Japan. GLP-1 = glucagon-like peptide-1; GLP-2 = glucagon-like peptide-2; GIP = glucose-dependent insulinotropic polypeptide; hu-mAb = humanized monoclonal antibody PR
Slide 8: Multiple potential inflection points over the next 12-18 months
multiple potential inflection points over the next 12-18 months Evaluate rest-of-world vurolenatide and global larazotide partnerships Obtained USAN name for vurolenatide Initiated Phase 2 vurolenatide trial FDA Type C meeting supports TSO primary end point for vurolenatide 1-2Q 2021 Initiated IND-e
Slide 9: Vurolenatide: long-acting GLP-1 agonist
vurolenatide: long-acting glp-1 agonist Short Bowel Syndrome (SBS); Orphan Designation 9
Slide 10: Short bowel syndrome is a debilitating orphan disease
short bowel syndrome is a debilitating orphan disease • Orphan disease (orphan designation granted) and an underserved market • Affects up to 20,000 people in the US with similar prevalence in EU1,2 • Severe disease characterized by a lack of gut motility with significant impact on quality of life •
Slide 11: Patients with SBS typically have compromised levels of GLP-1
patients with sbs typically have compromised levels of glp-1 • GLP-1 is naturally produced in a portion of the 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, c
Slide 12: Vurolenatide replaces GLP-1 and restores the ileal brake
vurolenatide replaces glp-1 and restores the “ileal brake” short bowel syndrome with glp-1 GLP-1 travels through the blood, which affects gut motility elsewhere in the body. Motility is slowed, allowing more time for nutrient uptake. Vurolenatide rapidly replaces physiological effects of missing GLP
Slide 13: Reasons to believe vurolenatide can advance SBS treatment
reasons to believe vurolenatide has the potential to advance the way we treat sbs *Vurolenatide remains investigational and under development. 13
Slide 14: Phase 1b/2a study: SBS clinical trial design
phase 1b/2a study: sbs clinical trial design *The study protocol called for an analysis of urine output; however, it proved difficult to measure in an ambulatory setting. open label, 2-dose, dose-escalation study of vurolenatide in adult patients with sbs Vurolenatide given twice, at 3 different dos
Slide 15: Phase 1b/2a trial: treatment-emergent adverse events
phase 1b/2a trial: treatment-emergent adverse events 50 mg cohort (n=3) General disorders and administrative site conditions Gastrointestinal disorders Nervous system disorders Skin and subcutaneous tissue disorders 100 mg cohort (n=4) 150 mg cohort (n=2) Any exposure to vurolenatide (n=9) TEAEs Sys
Slide 16: Phase 1b/2a efficacy: total stool output
phase 1b/2a efficacy: total stool output (tso) 50 50 50 100 100 100 100 150 150 22508 1900 1175 720 1285 2280 5390 2570 4850 12550 200 350 615 420 2000 3010 2150 3900 -9958 -1700 -825 -105 -865 -280 -2380 -420 -950 13950 300 - 325 2450† 1940 2600 1480 3000 -8558 -1600 - -395 1165 -340 -2790 -1090 -1
Slide 17: Summary of study results
summary of study results Study met its primary objective: Vurolenatide demonstrated an excellent safety and tolerability profile Vurolenatide demonstrated a clinically relevant improvement in total stool output (TSO) volume, supporting a clear “GO” decision for next phase of development Data support
Slide 18: FDA response on Phase 2 program
fda response on initiated phase 2 program FDA Type C meeting communication supported plan to initiate Phase 2 study with vurolenatide for SBS using TSO as the primary efficacy outcome measure Multicenter, double-blind, double-dummy, randomized placebo-controlled trial; FDA has provided global anchor
Slide 19: VIBRANT: Phase 2 SBS trial design & timeline
VIBRANT: phase 2 sbs trial design & timeline (n = 22) Site selection finalized: 5 primary + 2 backup Timeline: study initiated 2Q 2021 50 mg PBO Group 1 n=6 Group 2 n=6 Group 3 n=6 Group 4 n=4 Study population: all comers (regardless of phenotype and/or PS requirement) 50 mg PBO 50 mg 100 mg PBO 100
Slide 20: Larazotide: oral, non-absorbed tight-junction regulator
larazotide: oral, non-absorbed tight-junction regulator Celiac Disease; Fast-track Designation 20
Slide 21: Celiac disease: autoimmune disorder with a clear unmet need
celiac disease: autoimmune disorder with a clear unmet need genetic link • Worldwide prevalence of around 1% and on the rise1 • Celiac patients have a specific HLA class II gene variant2 • HLA-DQ2 (~95%) or • HLA-DQ8 (5%)2 • Genome-Wide Association Studies (GWAS) link disease to 4 genes involved wit
Slide 22: Larazotide improves intestinal barrier integrity in celiac disease
larazotide improves intestinal barrier integrity in celiac disease 22
Slide 23: Phase 2: PRO endpoints show robust treatment effect
phase 2: pro endpoints show robust treatment effect Placebo 0.50 mg 28.6% 14.3% 10.0% 20.0% 30.0% P = 0.022 0.0% % Re sp on de rs † 14.3% Treatment Effect Treatment effect greater than approved IBS brands with Phase 3 PROs (Xifaxan®, Viberzi®, Linzess®, Amitiza®, and Trulance®) CeD PRO* Responder† A
Slide 24: CEDLARA study: Phase 3 trial design in celiac disease
CEDLARA study: phase 3 trial design in celiac disease (n = 525) Screening/Eligibility Period 12-week Double-Blind Treatment Phase Primary Endpoint Analyzed at Week 12 Day 35 Week 5 Visit 1 Day 21 Week 3 Visit 2 Day 1 Baseline Visit 3 Day 28 ± 3 Week 4 Visit 4 Day 56 ± 3 Week 8 Visit 5 Day 84 ± 3 Wee
Slide 25: Near-term development milestones
near-term development milestones 2020 2021 2022 December Topline Vurolenatide Phase 1b/2a results March 23rd 9Meters SBS R & D Day Full data set review May Digestive Disease Week (DDW) conference Obtained vurolenatide USAN name 2022 Topline larazotide Phase 3 readout 2022 Interim analysis for larazo
Slide 26: Early stage development programs
early stage development programs 26
Slide 27: NM-003: long-acting GLP-2 agonist
nm-003: long-acting glp-2 agonist XTEN Ka nR ORI P Molecule is an NCE through recombinantly derived process teduglutide ~3.8 kDa Gln HisGly Ser SerAspPheAspGly Glu Met Asn ThrIleLeuAspAsnAlaAla LewArg Phe Asp Ile AsnTrpLeu IleIle ThrLys Thr Asp nm-003 ~77 kDa Gln His Gly Se r Se rA sp Ph e As pG ly
Slide 28: NM-102: tight-junction microbiome modulator
nm-102: tight-junction microbiome modulator1 non-ischemic ischemic larazotide nm-136 (0.1 uM) nm-136 (1.0 uM) nm-136 (10 uM) Electrophysiological responses and histomorphology of ischemia-injured porcine jejunal mucosa to treatment with single doses of nm-136 at various concentrations. Statistical s
Slide 29: NM-136: humanized anti-GIP monoclonal antibody
nm-136: humanized anti-GIP monoclonal antibody1 control nm-136 treated mouse white portions represents fat tissue 1. Boylan MO et al. Am J Physiol. 2015;309:E1008-E1018. 29 • nm-136 targets GIP, a hormone released into circulation after food is ingested • nm-136 prevents GIP from binding to its rece
Slide 30: Thank you
thank you John Temperato President, Chief Executive Officer & Director 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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