9 Meters Biopharma, Inc. · OTC:NMTRQ
9 Meters Biopharma — Investor Presentation (November 2022)
36 slides from 9 Meters Biopharma's investor presentation, Nov 29, 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 belie
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 – first and only long-acting GLP-1 agonist in Phase 3 development for short bowel syndrome (SBS) Straightforward strategy Employing cap
Slide 5: Highly experienced 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: Pipeline – One tract with multiple meaningful opportunities
NOTE: All products are New Chemical Entities; 9 Meters holds global rights to all assets * Clinical trial being conducted by European Biomedical Research Institute of Salerno (EBRIS) MIS-C = multisystem inflammatory syndrome in children; GLP-1 = glucagon-like peptide-1; GLP-2 = glucagon-like peptide
Slide 7: Vurolenatide: Long-acting GLP-1 agonist
Vurolenatide: Long-acting GLP-1 agonist Short Bowel Syndrome (SBS); Orphan Designation
Slide 8: 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 intestine1 Affects up to 20,000 people in the US with similar prevalence in EU2,3 Primary problem is impaired absorption with a significant impact on quality of life1,4 Conseque
Slide 9: Parenteral support dependency varies; severe diarrhea is a constant complication
Parenteral support (PS) dependency varies in frequency and magnitude; severe diarrhea is a constant complication for all SBS patients Vurolenatide is the only agent with the potential to address two critical unmet needs in SBS: 1.) Reducing PS while reducing disastrous and disabling diarrhea 2.) Off
Slide 10: Diarrhea leads to dehydration, nutritional deficiencies, & poor QoL
Diarrhea leads to dehydration, nutritional deficiencies, & poor QoL Significant Burden of Diarrhea Leads to… • Significant weight loss due to malabsorption • Dehydration and fatigue resulting from continuous management of bowel movements/ostomy bag • Patient avoidance of nutrition/hydration to reduc
Slide 11: 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 12: Vurolenatide leverages proven XTEN Technology
Vurolenatide leverages proven XTEN™ Technology vurolenatide 13 Optimized for SBS patients utilizing known effects of GLP-1 pharmacology *XTEN technology licensed from Amunix Inc. (a Sanofi company) Slows transit time for greater nutrient absorption Decreases degradation time for long half-life (>150
Slide 13: Vurolenatide target product profile
Vurolenatide target product profile* • Rapid and sustained reductions in PS, regardless of remnant anatomy • Rapid and sustained reductions in TSO regardless of PS status or remnant anatomy • Excellent safety and tolerability regardless of remnant anatomy • Improved QoL due to lower administration b
Slide 14: Phase 2 VIBRANT Study Results
Phase 2 VIBRANT Study Results VurolenatIde for short Bowel syndrome Regardless of pArental support requiremeNT
Slide 15: VIBRANT Phase 2 study design
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: Mean change
Slide 16: 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 17: Primary efficacy endpoint
Primary efficacy endpoint (n=11) Rapid and sustained reduction in 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 +2
Slide 18: 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 Rapid onset and sustained TSO reduction over time vs. placebo 6 of 9 (67%) on vurolenatide showed a TSO reduction with a 37% mean decrease *Three of 3 patie
Slide 19: TSO change over time by dose arm
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 arm; and 1 of 3 patients showed a decrease in the 100 mg Q2W arm +100 +120 -80 -60 -40 -20 +2
Slide 20: 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 –reported events consistent with GLP-1 agonists Overall C
Slide 21: Pharmacokinetic profile
Evidence of stacking effect* 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) Pharmacokinetic (PK) profile PK profile supports the selec
Slide 22: Decrease in parenteral support requirement
Decrease in parenteral support (PS) requirement Mean decrease by week 2 and 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 patien
Slide 23: VIBRANT Phase 2 summary of results
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 a m
Slide 24: Phase 3 VIBRANT Study
Phase 3 VIBRANT 2 Study VurolenatIde for short Bowel syndrome Regardless of pArental support requiremeNT
Slide 25: VIBRANT Phase 3 study design incorporates FDA input
VIBRANT 2 Phase 3 study design incorporates input from FDA and addresses all patients with SBS • Single Phase 3 trial; two patient sub-groups: ‐ Sub-group 1: On parenteral support at least 3 days per week ‐ Sub-group 2: All other SBS patients • Two primary endpoints with a single efficacy outcome* •
Slide 26: VIBRANT Phase 3 randomized study schema
VIBRANT 2 Double-blind, placebo-controlled study to evaluate the efficacy, safety, and tolerability of vurolenatide in adult patients with SBS 3 5 Vurolenatide ( ~ 30) non-PS Dependent Placebo (n ~ 15) Q2W – administered once every two-weeks Vurolenatide (n ~ 40) PS Dependent Vurolenatide 50 mg Q2W
Slide 27: VIBRANT Key clinical study parameters
VIBRANT 2 Key clinical study parameters Study Parameters Details Primary Endpoints #1: Change from baseline in mean weekly Parenteral Support (PS) volume #2: Change from baseline in mean 24-hr Total Stool Output (TSO) with maintenance of nutrition and no worsening of renal function Secondary Endpoin
Slide 28: Vurolenatide Phase 3 Program
Vurolenatide Phase 3 Program Addressing the needs of all patients with SBS regardless of parenteral support requirements VIBRANT 2 Phase 3 study Pivotal registration study inclusive of both patients dependent on parenteral support and all others VIBRANT 3 12-month safety extension Support of long-te
Slide 29: VIBRANT study designed to support global patient recruitment
VIBRANT 2 Phase 3 study designed to support global patient recruitment, adherence, and retention 29 Global Reach • Global Clinical Research Organization (CRO) with Phase 3 SBS operational experience • Inclusion of up to 50 sites in the U.S., Canada and Europe • Full SBS patient population is eligibl
Slide 30: Vurolenatide addresses critical unmet needs in the SBS market
Vurolenatide is intended to address critical unmet needs in the SBS market, representing a substantial commercial opportunity 30 No PS PS DependencySome PS 50 - 65% of Patients 1,2, 3 Diarrhea PS-Dependent (Gattex – low global adoption*) >$1.5bn Sales Opportunity* Gattex = $700 - $800MM Global Peak
Slide 31: Pre-Clinical Programs
no Pre-Clinical Programs =
Slide 32: NM-136 (proprietary humanized anti-GIP mAb)
• GIPenhances gut nutrient absorption, increases glucose uptake into fat cells, increases insulin and nutrient storage • NM-136 is a long-acting humanized anti-GIP mAb highly specific to human GIP hormone in circulation • Preclinical studies show that a reduction in GIP signaling appears to affect b
Slide 33: NM-102 is a tight-junction microbiome modulator
33 1. Yonekura, et. al. Cancer Discov (2022) 12 (4): 1128–1151. https://doi.org/10.1158/2159-8290.CD-21-0999 2. Bullman, S., et. al. Nat Cancer 2, 1301–1304 (2021). https://doi.org/10.1038/s43018-021-00300-x Gut dysbiosis may promote tumorigenesis1 Modulating ICI-resistant microbiome emerging as a v
Slide 34: Phase 2 clinical trial in MIS-C
• Ongoing Phase 2a trial* in MIS-C initiated in collaboration with European Biomedical Institute of Salerno (EBRIS) • Primary aim of the study is to evaluate the efficacy and safety of larazotide versus placebo in pediatric patients with SARS-CoV-2 infection who experience early signs of MIS-C and a
Slide 35: Anticipated 2023 milestones
Anticipated 2023 milestones • Vurolenatide: - Orphan Drug designation (EU) - Initiation of Phase 3 safety extension study • NM-136: - IND Submission - Phase 1 study initiation • NM-102: - Pre-IND meeting • Vurolenatide: - Phase 3 study initiation (EU) • NM-136: - Pre-IND meeting - NM-136 publication
Slide 36: Contact details
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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