9 Meters Biopharma, Inc. · OTC:NMTRQ
9 Meters Biopharma — Investor Presentation (November 2021)
30 slides from 9 Meters Biopharma's investor presentation, Nov 15, 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 presentation 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, anticipated milestones
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 1Q22 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 - One Tract with Multiple Meaningful Opportunities
NOTE: All programs are New Chemical Entities. NOTE: All programs are globally licensed except NM-004, which excludes Asia, except for Japan. *MIS-C = multisystem inflammatory syndrome in children clinical trial in collaboration with European Biomedical Research Institute of Salerno (EBRIS); GLP-1 =
Slide 8: Multiple Potential Inflection Points Through 2022
multiple potential inflection points through 2022 Evaluate rest-of-world vurolenatide and global larazotide partnerships 3Q 2021 Initiated IND-enabling pathway for NM-102 Initiated IND-enabling pathway for NM-003 Acquired and initiated IND-enabling pathway for NM-136 4Q 2021 Initiated larazotide Pha
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 impaired 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 Illustration of one phenotype of SBS with colon-in-continuity; Other phenotypes exist with and without colon-in-continuity 11 • GLP-1 is naturally produced in a portion of the ileum that is removed during surgical resection • Natural GLP-1
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 Vurolenatide was generally safe and well tolerated: 17 TEAEs were observed in 9 patients, 15 of which were mild, transient and self-limited without further intervention. The majority of TEAEs were GI-related (nausea and vomiting). 15
Slide 16: Phase 1b/2a Efficacy: Total Stool Output
phase 1b/2a efficacy: total stool output (tso) *Patient 6 did not receive a second dose. †The baseline prior to the second dose in this patient was substantially higher than the original baseline volume due to rapid increase in oral intake. lasting effect seen in patients, confirming single ascendin
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: topline results expected 1Q22 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 P
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 2b: 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% % R e sp o n d e 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
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 2021 2022 3Q21 Initiated IND-enabling pathway for NM-102 Initiated IND-enabling pathway for NM-003 Acquired and initiated IND-enabling pathway for NM-136 2H22 Topline larazotide Phase 2a MIS-C readout Top-line larazotide Phase 3 readout in celiac disease NM-102 indic
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 R Molecule is an NCE through recombinantly derived process teduglutide ~3.8 kDa Gln His Gly Ser SerAspPheAspGly Glu Met Asn ThrIleLeuAspAsnAlaAla LewArg Phe Asp Ile AsnTrpLeu IleIle ThrLys Thr Asp nm-003 ~77 kDa + 27 1. Alters SE, McLaughlin B, Spink B, et al.
Slide 28: NM-102: Tight-Junction Microbiome Modulator
nm-102: tight-junction microbiome modulator1 non-ischemic ischemic larazotide nm-102 (0.1 uM) nm-102 (1.0 uM) nm-102 (10 uM) Electrophysiological responses and histomorphology of ischemia-injured porcine jejunal mucosa to treatment with single doses of nm-102 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: Contact
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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