9 Meters Biopharma, Inc. · OTC:NMTRQ
9 Meters Biopharma — Investor Presentation (March 2023)
29 slides from 9 Meters Biopharma's investor presentation, Mar 13, 2023
Slide 1: Pioneering Novel Treatments
Pioneering Novel Treatments C L IN IC AL STAG E C O M PANY P IO NE E R ING NOVE L T R E AT M E NT S FO R PE O PL E W IT H R AR E O R D E B IL ITAT ING D IG E ST IVE D IS E AS E S with a one-tract mind
Slide 2: 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 any other statements relati
Slide 3: 9 Meters investor highlights
3 9 Meters investor highlights Late clinical-stage company pioneering novel treatments for people with rare or debilitating digestive diseases Phase 3 clinical program Vurolenatide – long-acting GLP-1 agonist in Phase 3 for SBS; data anticipated in 2H 2024 Addressing significant unmet needs Rare dis
Slide 4: 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 5: Vurolenatide: Long-acting GLP-1 agonist
Vurolenatide: Long-acting GLP-1 agonist SHORT BOWEL SYNDROME: ORPHAN DESIGNATION 5
Slide 6: Short bowel syndrome (SBS): a debilitating orphan disease
Short bowel syndrome (SBS): a debilitating orphan disease 6 1 . Jeppesen, P. Spectrum of Short Bowel Syndrome in Adults: Intestinal Insufficiency to Intestinal Failure. Journal of Parenteral and Enteral Nutrition Volume 38 Supplement 1 May 2014 8S–13S. 2. www.crohnscolitisfoundation.org. 3. EU/3/01/
Slide 7: Parenteral support dependency varies; severe diarrhea is constant
No standard clinical definition of PS2 Many patients do not meet GLP-2 regulatory criteria of PS at least 3x/week Diarrhea is constant regardless of PS use and is considered by patients “disastrous, disabling and degrading”4 NO PS PS DEPENDENCYSOME PS 50 - 65% of Patients1,2, 3 DIARRHEA 7 Parenteral
Slide 8: Vurolenatide replaces GLP-1 to restore ileal brake
Vurolenatide replaces GLP-1 to restore “ileal brake” 8 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 1 2 3
Slide 9: Target product profile
Target product profile* 9*Vurolenatide remains investigational and under development. Rapid and sustained reductions in PS regardless of remnant anatomy Rapid and sustained reductions in total stool output (TSO) regardless of PS status or remnant anatomy Excellent safety and tolerability regardless
Slide 10: Addressing critical unmet needs in the SBS market
Addressing critical unmet needs in the SBS market, and a potential substantial commercial opportunity 10 Sources: 1.) Mirador and Merative: Short Bowel Syndrome Population Analysis, October 2022 2.) Bionest SBS Qualitative Market Research, October 2022 3.) Messing et al. Long-term Survival and Paren
Slide 11: Potential new approach to treating SBS
Potential new approach to treating SBS 11 Vurolenatide Gattex® Teduglutide Glepaglutide Apraglutide Company 9 Meters Biopharma Takeda Zealand Pharma VectivBio Class (analog) GLP-1 agonist (slow GI transit) GLP-2 analog (grow villus architecture) GLP-2 analog (grow villus architecture) GLP-2 analog (
Slide 12: VIBRANT Study Results
12 Phase 2 VIBRANT Study Results VurolenatIde for short Bowel syndrome Regardless of pArenteral support requiremeNT
Slide 13: Rapid and sustained reduction in total stool output
62% DECREASE 40% DECREASE 13 -50 -40 -30 -20 -10 0 10 20 30 40 50 Rapid and sustained reduction in the primary study endpoint – weekly mean 24-hour TSO over a 6-week observation period T S O M e a n C h a n g e fr o m B a s e li n e (% ) 32% INCREASE 50 mg Q2W (n=3) 50 mg QW (n=3) Placebo (n=2) 100
Slide 14: Decrease in parenteral support requirement
-50 -40 -30 -20 -10 0 10 20 30 40 50 28% DECREASE Decrease in parenteral support requirement Mean decrease by week 2 and sustained over 6 weeks • Five of 11 patients were on PS, all on active drug • Mean decrease of 17% by week 2 and sustained throughout the 6-week observation period • Three of 5 pa
Slide 15: Pharmacokinetic profile supports 50 mg Q2W
15 Pharmacokinetic profile supports selection of vurolenatide 50 mg Q2W *Undesirable accumulation upon higher and/or more frequent repeat dosing Arrows denote doses given every week; all 3 groups on days 0, 14 and 28; 50 mg weekly given 2 additional doses (day 7 & day 21) Optimal PK profile Evidence
Slide 16: 50 mg Q2W safest and best-tolerated dose
50 mg Q2W demonstrated to be the safest and best-tolerated dose/regimen Treatment-emergent adverse events summary 16 No unexpected safety signals –reported events consistent with GLP-1 agonists Demographics Placebo 50 mg Q2W 50 mg QW 100 mg Q2W Nausea 0 0 1 4* Vomiting 1 0 0 2* Headache 0 0 1 1 Appe
Slide 17: Summary of results
Phase 2 summary of results 17 Provided further evidence of efficacy and identified a dose and patient population based on the totality of efficacy, safety, and PK for moving into Phase 3 Demonstrated a reduction in mean 24-hour total stool output over 6 weeks compared to placebo in the 50mg Q2W trea
Slide 18: VIBRANT Phase 3 Study
18 Phase 3 VIBRANT Study VurolenatIde for short Bowel syndrome Regardless of pArenteral support requiremeNT
Slide 19: VIBRANT study design incorporates FDA input
VIBRANT 2 Phase 3 study design incorporates input from FDA and addresses all patients with SBS 19 # Multiple Endpoints in Clinical Trials Guidance for Industry, FDA, October 2022 †Continuous variable as agreed to by FDA Two Primary Endpoints with a single efficacy outcome* ABSOLUTE CHANGE FROM BASEL
Slide 20: Phase 3 double-blind, placebo-controlled study design
Phase 3, double-blind, placebo-controlled study to evaluate the efficacy, safety, and tolerability of vurolenatide in adult patients with SBS 20Q2W – administered once every two weeks Enrollment SUB-GROUP 1 On parenteral support at least 3x per week SUB-GROUP 2 All other SBS patients N~120 24-WEEK A
Slide 21: Key clinical study parameters
Key clinical study parameters 21 First large ambulatory trial to assess ALL SBS PATIENTS Proprietary Smart technology platform to enhance stool output measurements across all cohorts Primary Endpoints Secondary Endpoints • Change from baseline in weekly mean body weight over the 24-week treatment pe
Slide 22: VIBRANT Program
Phase 3 Program 22 VIBRANT 2 VIBRANT 3 GLP-1/GLP-2 Addressing the needs of all patients with SBS regardless of parenteral support requirements Phase 3 study Pivotal registration study inclusive of both patients dependent on parenteral support and all others 12-month safety extension Support of long-
Slide 23: Study designed to support global patient recruitment
Phase 3 study designed to support global patient recruitment, adherence, and retention 23 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 eligible for scre
Slide 24: Pre-Clinical Programs
Pre-Clinical Programs 24
Slide 25: NM-136 first-in-class anti-GIP monoclonal antibody
NM-136 is a first-in-class humanized monoclonal antibody to glucose-dependent insulinotropic peptide (GIP) 25 NM-136 (proprietary humanized anti-GIP mAb) Boylan MO, Glazebrook PA, Tatalovic M, Wolfe MM. Am J Physiol Endocrinol Metab. 2015 Dec 15;309(12):E1008-18 GIP: ENHANCES • Gut nutrient absorpti
Slide 26: NM-102 tight-junction microbiome modulator
NM-102 is a tight-junction microbiome modulator 26 Gut dysbiosis may promote tumorigenesis1 26 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
Slide 27: Anticipated 2023 milestones
27 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 (US, EU) NM-136: Pre-IND meeting NM-136 publications NM-102: Pre-cli
Slide 28: Highly experienced leadership team
John Temperato PRESIDENT & CHIEF EXECUTIVE 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 Sarah Liu, MBA CHIEF COMMERCIAL OFFICER Al Medwar, M
Slide 29: Contact details
4509 Creedmoor Road Raleigh, NC 27612 Telephone: 1-919-275-1933 info@9meters.com www.9meters.com John Temperato President, Chief Executive Officer & Director jtemperato@9meters.com Bethany Sensenig, MBA, CMA Chief Financial Officer bsensenig@9meters.com Al Medwar, MBA SVP, Investor Relations & Corpo
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