9 Meters Biopharma, Inc. · OTC:NMTRQ
9 Meters Biopharma — Investor Presentation (May 2021)
26 slides from 9 Meters Biopharma's investor presentation, May 2021
Slide 1: A Champion in GI With A One Tract Mind
A Champion in GI With A One Tract Mind Focused on Rare and Unmet Needs in Gastroenterology Corporate Presentation
Slide 2: Forward Looking Statements
Forward Looking Statements This press release 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 or any other statements
Slide 3: Investment Highlights
Investment Highlights NASDAQ listed Vurolenatide: Larazotide: Focused on Leading (NMTR) Proprietary First drug to move increasing institutional focused on rare, long-acting GLP-1 into a Phase 3 trial shareholder investor support and unmet needs agonist for short in celiac disease value by creating i
Slide 4: Leadership Team
Leadership Team John Temperato President & CEO Edward Sitar Chief Financial Officer Patrick Griffin, MD Chief Medical Officer Sireesh Appajosyula, SVP, Corporate Development PharmD & Operations Nir Barak, MD SVP, Scientific Affairs 4
Slide 5: 9 Meters in Circuitous Length - But a Straight-Forward Strategy
9 Meters in Circuitous Length - But a Straight-Forward Strategy GI-Centric, Patient-Focused Develop Acquire / Acquire targeted clinical compounds capital efficient Partner Agnostic within GI tract if needs are unmet + regulatory aligned to focus Rare & unmet needs allows for predicates targete
Slide 6: 9 Meters Pipeline in Rare and Unmet Need GI Diseases
9 Meters Pipeline in Rare and Unmet Need GI Diseases PROGRAM INDICATION CLASS ROUTE PRE-CLINICAL PHASE 1 PHASE 2 PHASE 3 UPCOMING MILESTONES Larazotide Tight Junction Topline readout Regulator Oral; Gut Restricted Adult Celiac Disease Phase 3 → 2022 Vurolenatide Initiate Phase 2 → 2Q21 Long-Acting G
Slide 7: Multiple Potential Inflection Points Over Next 12-18 Months
Multiple Potential Inflection Points Over Next 12-18 Months 2Q 2021 3Q 2021 4Q 2021 2022 • Obtained USAN name • Initiate IND-enabling • Topline Phase 2 • Interim analysis for for NM-002: vurolenatide pathway for NM-102 readout of larazotide Phase 3 for vurolenatide trial celiac disease • Initiate Ph
Slide 8: Vurolenatide: Long-Acting GLP-1 Agonist
Vurolenatide: Long-Acting GLP-1 Agonist Short Bowel Syndrome (SBS); Orphan designation
Slide 9: Short Bowel Syndrome (SBS) is a Debilitating Orphan Disease
Short Bowel Syndrome (SBS) is a Debilitating Orphan Disease • Orphan disease (orphan designation granted) and an underserved market Normal SBS Patient • Affects up to 20,000 people in the US with similar prevalence in Length of GI Tract Length of GI Tract EU1,2 ~ 9.0 m / ~ 30 ft Significantly Shorte
Slide 10: Patients With SBS Typically Have No Natural GLP-1
Patients With SBS Typically Have No Natural GLP-1 • GLP-1 is naturally produced in a portion of 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 a lack of gut motility, causing an SBS p
Slide 11: SBS Patient Perspective on Chronic Diarrhea
SBS Patient Perspective on Chronic Diarrhea Indicative of Significant Impact Over the Last Decade The bathroom is probably the most If you want a one-word description [of I’m going so much I have no annoying thing… I always have plastic living with Short-Bowel Syndrome], life. I can’t go anywhere –
Slide 12: Vurolenatide Target Product Profile
Vurolenatide Target Product Profile Vurolenatide (proprietary long-acting GLP-1)* GLP-2 Class Profile ü Long acting GLP-1 receptor agonist – GLP-2 analogue ü Slows gut motility – Expand intestinal mucosa / villous growth ü Increases time for absorption of key nutrients – Limited effect on gut motili
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 4.2 kDa e GLP-1 travels through Ex His Gly GluGly ThrPheThrSerAsp the blood, which Leu P Ser affects gut motility Leu Arg Val Ala Glu Glu GluMetGln Lys Molecule is an NCE K anR through elsewhere
Slide 14: Phase 1b/2a Study: SBS Clinical Trial Design
Phase 1b/2a Study: SBS Clinical Trial Design Open label, two-dose, dose escalation study of vurolenatide in adult patients with SBS Key secondary outcomes: Vurolenatide given Doses were Main outcomes: Patients followed for 6 Total stool output(TSO); twice, at 3 different administered on Safety & wee
Slide 15: Phase 1b/2a Trial: Treatment Emergent Adverse Events
Phase 1b/2a Trial: Treatment Emergent Adverse Events Any exposure to 50 mg Cohort 100 mg Cohort 150 mg Cohort vurolenatide (n=3) (n=4) (n=2) (n=9) # of System Organ Class Preferred # of subjects # of events # of subjects # of events # of subjects # of events # of events subjects Term n (%) n n (%) n
Slide 16: Phase 1b/2a Efficacy: Total Stool Output (TSO)
Phase 1b/2a Efficacy: Total Stool Output (TSO) Vurolenatide First 48 Hours Change from First 48 Hours Change from Patient Baseline (mL) Dose (mg) Post Dose 1 (mL) Baseline (mL) Post Dose 2 (mL) Baseline (mL) 1 50 22508 12550 −9958 13950 −8558 2 50 1900 200 −1700 300 −1600 61 50 1175 350 −825 - - 3 1
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 Planned Vurolenatide Phase 2 Program
FDA Response on Planned Vurolenatide Phase 2 Program FDA Type C meeting communication supports plan to initiate Phase 2 study with vurolenatide for SBS using Total Stool Output (TSO) as the primary efficacy outcome measure Multi-center, double-blind, double-dummy, randomized placebo-controlled trial
Slide 19: Proposed Vurolenatide Study Design & Timeline
Proposed Vurolenatide Study Design & Timeline Treatment Day Group n 0 7 14 21 28 1 6 50 mg PBO 50 mg PBO 50 mg 2 6 100 mg PBO 100 mg PBO 100 mg 3 6 50 mg 50 mg 50 mg 50 mg 50 mg 4 4 PBO PBO PBO PBO PBO • Study population: all comers (regardless of phenotype and/or PS requirement) • Site selection fi
Slide 20: Larazotide: Oral, Non-Absorbable Tight-Junction Regulator
Larazotide: Oral, Non-Absorbable Tight-Junction Regulator Celiac Disease
Slide 21: Celiac Disease: Autoimmune Disorder with a Genetic Link
Celiac Disease: Autoimmune Disorder with a Genetic Link Triggered by dietary gluten • Intestinal epithelia barrier leakiness leads to “Intestinal- Inflammatory Loop” • Eventually, intestinal surface (villi) become atrophied Genetic link • Worldwide prevalence of around 1% and on the rise1 ‒ Celiac p
Slide 22: Larazotide Normalizes Intestinal Barrier in Celiac Disease
Larazotide Normalizes Intestinal Barrier in Celiac Disease 22
Slide 23: Phase 2: PRO Endpoints Show Robust Treatment Effect
Phase 2: PRO Endpoints Show Robust Treatment Effect CeD-GSRS: CeD PRO1 Responder2 Analysis P2b Trial Primary Endpoint for Phase 2b 30.0% p = 0.022 28.6% 20.0% 14.3% % Responders* Treatment Effect 14.3% 10.0% 0.0% Placebo 0.50mg Dose 0.5mg 1mg 2mg n=84 for Placebo and n=84 for 0.5 mg dose CeD GSRS1 p
Slide 24: Phase 3 Trial Design in Celiac Disease (n = 525)
Phase 3 Trial Design in Celiac Disease (n = 525) 12-week Double-Blind Treatment Phase Screening/Eligibility Period 12-week Double-Blind Safety Phase 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 Week 3 Baseline Week 4 Week 8
Slide 25: Near Term Inflection Points
Near Term Inflection Points December May 4Q21 2022 Topline vurolenatide Obtained NM-002 USAN Topline vurolenatide Top-line larazotide Phase 1b/2a results name: vurolenatide Phase 2 results in SBS phase 3 readout American College of Gastroenterology (ACG) conference 2020 2021 2022 May 4Q21 Attendance
Slide 26: Thank You
Thank You John Temperato President & CEO 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
9 Meters Biopharma — Investor Presentation (May 2021) on 6ix