9 Meters Biopharma, Inc. · OTC:NMTRQ
9 Meters Biopharma — Investor Presentation (September 2022)
30 slides from 9 Meters Biopharma's investor presentation, Sep 26, 2022
Slide 1: Pioneering Novel Treatments with a one-tract mind
1 Pioneering Novel Treatments with a one-tract mind CLINICAL STAGE COMPANY P IONEERING NOVEL TREATMENTS FOR PEOPLE WITH RARE OR DEBIL ITAT ING DIGEST IVE D ISEASES
Slide 2: Forward-looking statements
Forward-looking statements This presentation includes forward-looking statements based upon 9 Meters' current expectations. Forward-looking statements include, but are not limited to, statements that express our intentions, beliefs, expectations, strategies, predictions, anticipated milestones, and
Slide 3: 9 Meters is putting the power of gut biology to work
9 Meters is putting the power of gut biology to work • Advancing vurolenatide for SBS • Harnessing GI biology to build an innovative pipeline • Novel and meaningful outcomes for patients, providers, and payers through relief from the burdens of GI disease • Meaningful returns to investors who believ
Slide 4: Investor highlights
Investor highlights Clinical stage company pioneering novel treatments for people with rare or debilitating digestive diseases Phase 3 clinical program Vurolenatide - proprietary long-acting GLP-1 agonist for short bowel syndrome with plans to initiate Phase 3 study as early as 4Q Straightforward st
Slide 5: Leadership team
John Temperato PRESIDENT & CHIEF EXECUTIVE OFFICER Bethany Sensenig, MBA, CMA CHIEF FINANCIAL OFFICER Patrick H. Griffin, MD CHIEF MEDICAL OFFICER Sireesh Appajosyula, PharmD SVP, CORPORATE DEVELOPMENT & OPERATIONS Nir Barak, MD SVP, SCIENTIFIC AFFAIRS Matthew D. Bryant, PharmD VP, MEDICAL AFFAIRS S
Slide 6: A straight-forward strategy
Acquire focus on unmet needs Develop/ Partner capital efficient development pathways Commercialize efficient US footprint; strategic ROW partnerships Rare, unmet GI diseases Digestive disease-centric, patient-focused • Acquire targeted clinical compounds • Rare & unmet needs allow for targeted patie
Slide 7: Pipeline – One tract with multiple meaningful opportunities
NOTE: All programs are New Chemical Entities. NOTE: Global rights to all assets. *MIS-C = multisystem inflammatory syndrome in children; clinical trial in collaboration with European Biomedical Research Institute of Salerno (EBRIS) GLP-1 = glucagon-like peptide-1; GLP-2 = glucagon-like peptide-2; GI
Slide 8: Near-term development milestones
Near-term development milestones 2022 2H22 • Vurolenatide (SBS) end-of-Phase 2 meeting with FDA • Vurolenatide (SBS) Phase 2 final results • Vurolenatide (SBS) Phase 3 protocol finalization • Vurolenatide (SBS) Phase 3 trial initiation • NM-102 progression toward IND • NM-136 progression toward IND
Slide 9: Vurolenatide: Long-acting GLP-1 agonist
Vurolenatide: Long-acting GLP-1 agonist Short Bowel Syndrome (SBS); Orphan Designation
Slide 10: Short bowel syndrome: a debilitating orphan disease
Short bowel syndrome: a debilitating orphan disease Short bowel syndrome (SBS) results from massive resection of the small intestine due to recurrent Crohn’s disease, mesenteric vascular events, trauma, malignancy or complications from abdominal surgery1 Short bowel syndrome affects up to 20,000 peo
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 Natural GLP-1 prevents the GI tract from moving rapidly: known as an “ileal brake” • GLP-1 is naturally produced in
Slide 12: Short bowel syndrome patient journey
Short bowel syndrome patient journey Sources: 1.) Messing et al. Long-term Survival and Parenteral Nutrition Dependence in Adult Patients with the Short Bowel Syndrome. Gastroenterology 1999. 2.) Winkler, Marion. Et al. An Exploration of Quality of Life and the Experience of Living with Home Parente
Slide 13: Vurolenatide replaces GLP-1 and restores ileal brake
Vurolenatide replaces GLP-1 and restores “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 replaces physiological effects of missing GLP-1 to normal
Slide 14: Vurolenatide target product profile
Long-Acting GLP-1 Slowing Gut Motility and Restoring Nutrient Absorption Vurolenatide target product profile* *Vurolenatide remains investigational and under development. 14 A solution for SBS patients across the spectrum of disease • Rapid and Sustained reductions in TSO • Rapid and sustained reduc
Slide 15: VIBRANT Phase 2 Study Results
Phase 2 VIBRANT Study Results VurolenatIde for short Bowel syndrome Regardless of pArental support requiremeNT
Slide 16: VIBRANT Phase 2 study design and goals
VurolenatIde for short Bowel syndrome Regardless of pArenteral support requiremeNT Phase 2, double-blind, double-dummy, placebo-controlled multicenter study of the efficacy, safety and tolerability of vurolenatide in adult patients with short bowel syndrome (SBS) Primary study endpoint: Study goals:
Slide 17: VIBRANT SBS trial design & timeline
VIBRANT Phase 2 SBS trial design & timeline (n = 11*) Screening/Baseline Period 28-Day Double-Blind Treatment Phase Day -21 Screening begins Day -6 Diary collection begins Day 0 Double-blind treatment phase begins Day 28 Double-blind treatment phase ends Day 42 End of 6-wk observation phase Day 70 S
Slide 18: Study demographics & patient phenotype
Study demographics & patient phenotype Demographics Placebo 50 mg Q2W 50 mg weekly 100 mg Q2W N (12)* 2 3 3 4 Sex (m/f) 2(m) 3(f) 1(m);2(f) 3(m);1(f) Age (mean, y) 56 50 58 47 Weight (mean, kg) 69.4 66.5 67.4 70.9 White 2 2 2 4 Black or African American - 1 1 - Non-Hispanic or Latino 2 3 3 3 Post-Op
Slide 19: Primary efficacy endpoint
Primary efficacy endpoint (n=11) Weekly mean 24-hour total stool output (TSO) over the 6-week observation period placebo (n=2) 50 mg Q2W (n=3) 50 mg weekly (n=3) 100 mg Q2W (n=3) 0 -10 +50 T S O M e a n C h a n g e fr o m B a s e li n e , % -20 -30 -40 -50 +40 +30 +20 +10 32% increase 30% decrease 8
Slide 20: Rapid onset and sustained TSO reduction over time
Rapid onset and sustained TSO reduction over time 50 mg Q2W showed reduction at week 1 and maintained over 6 weeks 50 mg Q2W (n=3); 50 mg weekly (n=3); 100 mg Q2W (n=3); ↓ dose ↓ dose ↓ dose placebo (n=3); ↓ dose Note: Three of 3 patients showed a decrease in TSO in the 50 mg Q2W arm; 2 of 3 patient
Slide 21: Relative TSO change from baseline vs. placebo
Relative TSO change from baseline vs. placebo 50 mg Q2W shows consistent decrease over time 50 mg Q2W (n=3); 50 mg weekly (n=3); 100 mg Q2W (n=3); ↓ dose ↓ dose ↓ dose Note: Three of 3 patients showed a decrease in TSO in the 50 mg Q2W arm; 2 of 3 patients showed a decrease in the 50 mg every week a
Slide 22: Weeks with consistent TSO reduction
50 mg Q2W arm shows 16 of 18 weeks with consistent TSO reduction* 100 50 mg Q2W (n=3) 50 mg weekly (n=3) 100 mg Q2W (n=3) 20 0 40 60 80 % P a ti e n t W e e k s 16 of 18 (89%) weeks with decreased 24-hour TSO 12 of 18 weeks with decreased 24-hour TSO 6 of 18 weeks with decreased 24-hour TSO Observat
Slide 23: Vurolenatide any dose with TSO decrease
vurolenatide any dose with TSO decrease* (n=6) 0 -10 +50 M ea n C h a n g e fr o m B as e lin e, % -20 -30 -40 -50 +40 +30 +20 +10 37% decrease 6 of 9 (67%) on active treatment showed a TSO reduction with a mean decrease of 37% *Three of 3 patients showed a decrease in TSO in the 50 mg Q2W arm; 2 of
Slide 24: Vurolenatide 50 mg Q2W shows optimal pharmacokinetic profile
Evidence of stacking effect* (suboptimal PK) Optimal PK profile *Undesirable accumulation upon higher and/or more frequent repeat dosing Arrows denote doses given every week; all 3 groups on day 0, 14 and 28; 50 mg weekly given 2 additional (day 7 & day 21) Vurolenatide 50 mg Q2W shows optimal pharm
Slide 25: Patients on parenteral support
Patients on parenteral support (PS) Mean decrease by week 2 & sustained over 6 weeks all PS patients* (n=5) 0 -10 +50 M e a n C h a n g e fr o m B a se li n e , % -20 -30 -40 -50 +40 +30 +20 +10 17% decrease *PS was a secondary endpoint: mean 24-hour weekly PS volume; three of 5 patients (all random
Slide 26: Treatment-emergent adverse events summary
Demographics Placebo 50 mg Q2W 50 mg weekly 100 mg Q2W Nausea 0 0 1 4* Vomiting 1 0 0 2* Headache 0 0 1 1 Appetite Loss 0 0 0 1 Abdominal Pain 0 1 0 0 Hypertension 1 0 0 0 Treatment-emergent adverse events summary No unexpected safety signals – all reported events consistent with GLP-1 agonist class
Slide 27: VIBRANT Phase 2 summary of results
27 VIBRANT Phase 2 summary of results Demonstrated a reduction in mean 24-hour total stool output (TSO) over 6 weeks compared to placebo in the 50mg Q2W treatment arm: • Mean 24-hour TSO decrease for the 50 mg vurolenatide Q2W treatment arm was 30% versus an increase of 32% in the placebo arm – for
Slide 28: Clinical & regulatory next steps
Clinical & regulatory next steps FDA EOP2 communication supports plan to initiate next phase of clinical development: Phase 3 protocol designed & powered as a pivotal registration program Clinical program will consist of North American (US, Canada) & European sites: Feasibility & site recruitment we
Slide 29: Near-term development milestones
Near-term development milestones 2022 2H22 • Vurolenatide (SBS) end-of-Phase 2 meeting with FDA • Vurolenatide (SBS) Phase 2 final results • Vurolenatide (SBS) Phase 3 protocol finalization • Vurolenatide (SBS) Phase 3 trial initiation • NM-102 progression toward IND • NM-136 progression toward IND
Slide 30: Contact
John Temperato President, Chief Executive Officer & Director jtemperato@9meters.com 8480 Honeycutt Road, Suite 120 Raleigh, NC 27615 Telephone: 1-919-275-1933 info@9meters.com www.9meters.com Twitter LinkedIn Bethany Sensenig, MBA, CMA Chief Financial Officer bsensenig@9meters.com Al Medwar, MBA SVP
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