9 Meters Biopharma, Inc. · OTC:NMTRQ
9 Meters Biopharma — Investor Presentation (July 2022)
34 slides from 9 Meters Biopharma's investor presentation, July 2022
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 1
Slide 2: Forward-looking statements
forward-looking statements This presentation includes forward-looking statements based upon COVID-19 on our operations, enrollment in and timing of clinical trials; the Company's current expectations. Forward-looking statements risks related to leveraging the Company by borrowing money under include
Slide 3: Changing the world for patients
changing the world for patients vision mission Changing the world through novel Developing innovative treatments to therapeutic approaches that treat people liberate patients from rare and with rare and debilitating conditions via underserved diseases through our deep unique gut related pathways. un
Slide 4: Investor highlights
investor highlights 9 meters at a glance robust preclinical pipeline Clinical stage company pioneering novel Promising preclinical pipeline addressing treatments for people with rare or unmet needs in GI diseases debilitating digestive diseases vurolenatide a straight-forward strategy Proprietary lo
Slide 5: Leadership team
leadership team John Temperato PRESIDENT & CHIEF EXECUTIVE OFFICER Bethany Sensenig, MBA, CMA CHIEF FINANCIAL OFFICER Patrick H. Griffin, MD CHIEF MEDICAL OFFICER Sarah Liu, MBA CHIEF COMMERCIAL OFFICER Sireesh Appajosyula, PharmD SVP, CORPORATE DEVELOPMENT & OPERATIONS Nir Barak, MD SVP, SCIENTIFIC
Slide 6: 9 meters in circuitous length, but a straight-forward strategy
9 meters in circuitous length BUT A STRAIGHT-FORWARD STRATEGY digestive disease-centric, patient-focused develop acquire/ capital efficient partner • Acquire targeted clinical compounds & regulatory aligned to • Agnostic within GI tract if needs are unmet predicates focus • Rare & unmet needs allow
Slide 7: Pipeline – one tract with multiple meaningful opportunities
pipeline – one tract with multiple meaningful opportunities PROGRAM CLASS ROUTE PRE-CLINICAL PHASE 1 Indication PHASE 2 PHASE 3 MILESTONES Vurolenatide Phase 3 initiation → as early as Long-Acting GLP-1 Injectable Short Bowel Syndrome 4Q 2022 Larazotide Tight Junction Enrollment on hold. Next steps
Slide 8: Multiple potential inflection points through 2022
multiple potential inflection points through 2022 1H 2022 2H 2022 Vurolenatide (SBS) Phase 2 trial Vurolenatide (SBS) end-of-Phase 2 Larazotide (MIS-C) Phase 2a preliminary results meeting with FDA (mid-3Q) trial data Larazotide (Celiac) Phase 3 trial Vurolenatide (SBS) Phase 2 data NM-102 preclinic
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 sbs patient normal EU1,2 Length of GI Tract Length of GI Tract ~9.0 m/~30 ft Significantly Shortened • Seve
Slide 11: The patient journey: short bowel syndrome
the patient journey: short bowel syndrome Diarrhea, Fatigue, Abdominal Pain, Ostomy Leakage, Infusion Schedules, Social Impact2 Average Age at Factors related to PN Overall Mortality 10 Constitution: 52 Years Dependency: Years Post Resection: • Remnant Small Bowel 40% Remnant Small Length Among PN B
Slide 12: 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 unregulated gut motility,
Slide 13: Vurolenatide replaces GLP-1 and restores the ileal brake
vurolenatide replaces glp-1 and restores the “ileal brake” short bowel syndrome with glp-1 exenatide XTEN GLP-1 travels through the blood, which ~4.2 kDa affects gut motility elsewhere in the body. + His Gly Glu Gly ThrPheThr SerAsp Leu Ser Molecule is an NCE through R Arg Val Ala Glu Glu GluMetGln
Slide 14: Reasons to believe vurolenatide has the potential to advance SBS treatment
reasons to believe vurolenatide has the potential to advance the way we treat sbs Vurolenatide GLP-2 Class • Slows gut motility; increases time for absorption of • Expands intestinal mucosa/villous growth; limited Profile key nutrients effect on gut motility • Improvement in total stool output volum
Slide 15: FDA response on Phase 2 program
fda response on 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 provided global anchor questions and
Slide 16: VIBRANT Phase 2 study
VIBRANT (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: •
Slide 17: VIBRANT Phase 2 study design
VIBRANT phase 2 study design Screening/Baseline Period 28-Day Double-Blind Treatment Phase Post Treatment Follow-up Period Day -21 Day -6 Day 0 Day 28 Day 42 Day 70 Screening Dairy collection Double-blind treatment Double-blind treatment End of 6-wk Study End begins begins phase begins phase ends as
Slide 18: VIBRANT demographics, disposition and phenotype
VIBRANT demographics, disposition and phenotype Demographics • N=11; Male (3), Female (8) • Mean age: 54 years (range 44 – 67) • Race: White (9), Black/African American (2) • Ethnicity: Non-Hispanic or Latino (11) Study Disposition • No patient withdrew from study SBS Anatomic Phenotype • Ostomy pat
Slide 19: VIBRANT Phase 2 study objectives met
VIBRANT phase 2 study objectives met Safety and tolerability confirmed • No adverse events leading to study withdrawal • 2 serious adverse events (SAEs): central catheter infections (unrelated to study drug) Efficacy confirmed • 7 of 11 patients met definition for TSO responder over 6-week treatment
Slide 20: VIBRANT 2 Phase 3 study initiation timeline and planning
VIBRANT 2 phase 3 study initiation timeline and planning Phase 3 study anticipated to enroll first patient as early as 4Q 2022 pending outcome of end-of-Phase 2 meeting with FDA • Clinical study sites in U.S., Canada and up to 7 E.U. countries • All VIBRANT phase 2 sites will be first to be initiate
Slide 21: Short bowel syndrome: a debilitating orphan disease
short bowel syndrome: a debilitating orphan disease Results from massive resection of the small intestine due to recurrent Crohn’s disease, mesenteric vascular events, trauma, malignancy or complications from abdominal surgery1 Clinical consequences are far reaching • Includes malnutrition, diarrhea
Slide 22: Vurolenatide is poised to address unmet needs in the SBS market
Vurolenatide is poised to address unmet needs in the SBS market ~15-20K SBS patients in US ~11K SBS patients in EU4 +UK and Canada Intestinal Intestinal Insufficiency Failure Vurolenatide aims to treat SBS along the full • Gattex/Revestive (teduglutide) target spectrum of disease by slowing gut moti
Slide 23: Larazotide: oral, non-absorbed tight-junction regulator
larazotide: oral, non-absorbed tight-junction regulator Celiac Disease; Fast-track Designation 23
Slide 24: Celiac disease: autoimmune disorder with a clear unmet need
celiac disease: autoimmune disorder with a clear unmet need Triggered by dietary gluten • Intestinal epithelial barrier leakiness leads to intestinal inflammatory loop • Eventually, intestinal surface villi become atrophied • Inadequately managed celiac can lead to complications including malnutriti
Slide 25: Larazotide improves intestinal barrier integrity in celiac disease
larazotide improves intestinal barrier integrity in celiac disease 22 25
Slide 26: CeDLara Study: Enriched Phase 3 Trial Design in Celiac Disease
CeDLara Study: Enriched Phase 3 Trial Design in Celiac Disease (n = ~525) 12-week Double-Blind Treatment Phase 12-week Double-Blind Safety Phase Screening/Eligibility Period Primary Endpoint Analyzed at Week 12 Day -35 Day -21 Day 1 Day 28 ± 3 Day 56 ± 3 Day 84 ± 3 Day 112 ± 3 Day 168 ± 3 Week 5 Wee
Slide 27: Near-term development milestones
near-term development milestones 2022 1H22 2H22 • Vurolenatide (SBS) Phase 2 trial preliminary • Vurolenatide (SBS) end-of-Phase 2 meeting with FDA results • Vurolenatide (SBS) Phase 2 data presentation • Larazotide (celiac) Phase 3 trial interim analysis • Vurolenatide (SBS) Phase 3 trial initiatio
Slide 28: Early stage development programs
early stage development programs 28
Slide 29: Multisystem inflammatory syndrome in children (MIS-C)
multisystem inflammatory syndrome in children (MIS-C) • MIS-C is a rare but serious condition associated with COVID-19 in which different body parts become inflamed, including the heart, lungs, kidneys, brain, skin, eyes, or GI organs • MIS-C occurs when SARS-CoV-2 superantigens move through the tig
Slide 30: Phase 2 clinical trial in MIS-C
phase 2 clinical trial in MIS-C • Massachusetts General Hospital for Children contacted 9 Meters in February 2021 to request a single-use Expanded Access EUA to treat a child with MIS-C • A study published in JCI in May 2021 demonstrated a decrease in plasma SARS-CoV-2 Spike antigen levels, a decrea
Slide 31: NM-003: long-acting GLP-2 agonist
nm-003: long-acting glp-2 agonist 1 teduglutide XTEN ~3.8 kDa + His GlyAspGly SerPheSerAspGlu Met Asn Molecule is an NCE through R Arg Ala AlaLewAsnAspLeu Ile Thr Asp Phe recombinantly Ile AsnTrpLeu Ile Gln Thr Lys Ile Thr derived process Asp nm-003 ~77 kDa 1. Alters SE, McLaughlin B, Spink B, et al
Slide 32: NM-102: tight-junction microbiome modulator
nm-102: tight-junction microbiome modulator1 non-ischemic • nm-102 is a tight-junction modulator chemically distinct from larazotide ischemic • Data from ex vivo porcine tissue (shown) larazotide details tissue recovery nm-102 (0.1 uM) • Collaboration with Gustave-Roussy Institute nm-102 (1.0 uM) (P
Slide 33: NM-136: humanized anti-GIP monoclonal antibody
nm-136: humanized anti-GIP monoclonal antibody1 control nm-136 treated mouse • nm-136 targets GIP, a hormone released into circulation after food is ingested • nm-136 prevents GIP from binding to its receptor and shown to decrease weight and abdominal fat in pre-clinical models • IND-enabling pathwa
Slide 34: Contact: John Temperato, Bethany Sensenig, Al Medwar
John Temperato Bethany Sensenig, MBA, CMA Al Medwar, MBA President, Chief Executive Officer & Director Chief Financial Officer SVP, Investor Relations & Corporate Communications [email protected] [email protected] [email protected] 8480 Honeycutt Road, Suite 120 Raleigh, NC 27615 Telephon
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