9 Meters Biopharma, Inc. · OTC:NMTRQ
9 Meters Biopharma — Innovate Biopharmaceuticals — Merger or Acquisition (May 2020)
27 slides from 9 Meters Biopharma's merger presentation, May 4, 2020
Slide 1: A New Champion in GI With A One Tract Mind
A New Champion in GI With A One Tract Mind Focused on Rare, Orphan & Unmet Needs April 2020
Slide 2: Forward Looking Statements
Forward Looking Statements This presentation includes forward-looking statements including, but not limited to, statements related to our operations and business strategy and the development of drug candidates. The forward-looking statements contained in this press release are based on management’s
Slide 3: Summary of Key Merger Terms
Summary of Key Merger Terms • All stock merger between RDD Pharma Ltd. and Innovate Biopharmaceuticals, Inc. • Post merger closing, the company will change its name to 9 Meters Biopharma, Inc. (NMTR) Deal Terms • Acquisition of Naia Rare Diseases for cash and equity consideration soon after • Transa
Slide 4: Investment Highlights: A Powerful Combination
Investment Highlights: A Powerful Combination NASDAQ listed company focused on rare, orphan and unmet needs in gastrointestinal disorders NM-002: Novel therapeutic approach for Short Bowel Syndrome, an underserved, debilitating orphan disease with multiple near-term data read-outs Larazotide: First
Slide 5: Board of Directors
Board of Directors* Mark Sirgo, PharmD Chairman John Temperato CEO & Director Nissim Darvish, MD, PhD Director Lorin Johnson, PhD Director Steve Laumas, MD Director * *Ongoing Board after merger close 5
Slide 6: Diverse Pipeline Led by Programs in Celiac Disease and Short Bowel Syndrome
Diverse Pipeline Led by Programs in Celiac Disease and Short Bowel Syndrome Program Class (Route) Indication Type R & D Phase 1 Phase 2 Phase 3 Rights Next Update Tight Junction Topline readout Celiac Larazotide Regulator NCEPhase 3 Ongoing Global Phase 3 CeD study Disease (Oral; Gut Restricted) 2
Slide 7: Multiple Inflection Points Over Next Months
Multiple Inflection Points Over Next 24 Months 1H 2020 2H 2020 1H 2021 2H 2021 9 Meters Biopharma, Inc. Initiate Phase 1/2 SBS Top-line results Phase 1/2 Start Phase 3 SBS fully integrated post Study (NM-002) SBS (NM-002) Study (NM-002) mergers with Innovate and Initiate monetization of Interim look
Slide 8: Proforma Cap Structure Post-Merger
Proforma Cap Structure Post-Merger • Shares outstanding ‒ INNT (incl. all options): ~46M ‒ RDD (newly issued shares): ~44M ‒ INNT warrants (as exercised): ~15M Fully Diluted shares: ~105M* *Does not include concurrent financing; additionally $2.85 M distributed to NAIA as part of the upfront for the
Slide 9: Short Bowel Syndrome (SBS)
Short Bowel Syndrome (SBS) Novel approach using a Long-Acting GLP-1 Agonist (NM-002; Orphan Designation)
Slide 10: Short Bowel Syndrome (SBS) is a Debilitating Orphan Disease
Short Bowel Syndrome (SBS) is a Debilitating Orphan Disease Orphan disease (orphan designation granted) with a large underserved market Affects up to 20,000 people in the U.S. with similar prevalence in Europe1,2 Normal SBS patient Length of gastrointestinal tract Length of gastrointestinal tract5 S
Slide 11: New Approach to SBS with Long-Acting GLP-1 Agonist
New Approach to SBS with Long-Acting GLP-1 Agonist Long Acting GLP-1 (exenatide) licensed from Amunix • Developed specifically for SBS patients & gastric effects • Dosing twice monthly; potentially monthly • Different from GLP-1s used in diabetes & pancreatic effects • Potentially lowers drug exposu
Slide 12: Key Advantages of GLP-1 vs GLP-2 in SBS
Key Advantages of GLP-1 vs GLP-2 in SBS Long-acting GLP-1 (NM-002) GLP-2 Analogues Frequency of Dose Twice monthly; potentiallymonthly Daily injection to once-weekly forms GLP-1 class AEs mild and tolerable; potentially Safety REMS: Neoplastic growth warning (trophic) less due to lower exposure • Pr
Slide 13: NM-002 GI Safety in Diabetic Patients
NM-002 GI Safety in Diabetic Patients (P1 Single-Dose Study) Gastrointestinal Side Effect 12.5 mg 25 mg 50 mg 100 mg 150 mg 200 mg PBO Overall Reported (n=8) (n=10) (n=9) (n=8) (n=9) (n=8) (n=18) (n=70) Nausea 0 1 (10%) 1 (11%) 2 (25%) 8 (89%) 5 (63%) 2 (11%) 19 (27%) Dyspepsia 0 0 0 1 (13%) 1 (11%)
Slide 14: Proof-of-Concept of Exenatide in SBS Patients
Proof-of-Concept of Exenatide (GLP-1 agonist) in SBS Patients • Five patients with SBS based on <90 cm of small bowel and clinical evidence of nutritional deprivation selected • Each patient started on 5µg dose of exenatide BID and continued over the following month, baseline parameters repeated • T
Slide 15: Phase 1b/2a SBS Proposed Clinical Study Design
Phase 1b/2a SBS Proposed Clinical Study Design 7 Day Safety 7 Day Safety 7 Day Safety Assessment Assessment Cohort 2 Assessment Cohort 1 (50 mg) (100 mg) n= 2 to 5 n=2 to 5 Cohort 1 (50 mg) Total n = 12 to 30 Screening n= 2 to 5 Cohort 2 (100 mg) n=2 to 5 Cohort 3 Cohort 3 (150 mg) (150 mg) n=2 to 5
Slide 16: Comparable Deals/Companies in SBS
Comparable Deals/Companies in SBS Two companies have been acquired with GLP-2 analogues for SBS; a third public company, Zealand (NASDAQ:ZEAL), is developing a GLP-2 analogue for SBS October 2015 May 2019 August 2017 Acquires for $340 million upfront+ $470 Approved for SBS in 2012 million CVRs (2019
Slide 17: Celiac Disease Larazotide: Oral, Non-Absorbable, Tight-Junction Regulator
Celiac Disease Larazotide: Oral, Non-Absorbable, Tight-Junction Regulator
Slide 18: 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 GI Abdomin
Slide 19: Larazotide Normalizes Intestinal Barrier in Celiac Disease
Larazotide Normalizes Intestinal Barrier in Celiac Disease Preventing Antigen Trafficking Larazotide is an 8 natural amino acid peptide which normalizes disrupted tight junctions (IFN α, IFN γ, TNF, IL 4, IL 5 and IL 21) Adapted from: Withoff, S., Li, Y., Jonkers, I. and Wijmenga, C., 2016. Understa
Slide 20: Lack of Absorption → Unique Pharmacology
Lack of Absorption → Unique Pharmacology as Cleaved Fragment Accumulates, it Inhibits Larazotide Brush Border Peptidase Cleaves Larazotide to a Translates to Clinically Relevant Doses 6-mer (Fragment 2) in Clinical Trials Porcine Intestine Ussing Chamber studies showed larazotide normalizes tight ju
Slide 21: Phase 2b Celiac Disease Trial Design
Phase 2b Celiac Disease Trial Design Inclusion Criteria 14-day 28-day Single- 28-day Single- 84-day (12-week) Screening blind Placebo blind Placebo Double-blind Treatment Phase • 18–75 years old with BMI between 16–45 kg/m2 Period Run-in Phase Run-in Phase • CeD confirmed by intestinal biopsy or cap
Slide 22: PRO Endpoints Show Robust Treatment Effect
PRO Endpoints Show Robust Treatment Effect CeD-GSRS: CeD PRO1 Responder2 Analysis P2b Trial Primary Endpoint for Phase 2b (‘012) Primary Endpoint for Phase 3 p = 0.022 30.0% 28.6% 20.0% 14.3% ____ Treatment Effect 14.3% 10.0% % Responders* 0.0% Placebo 0.50mg Dose 0.5mg 1mg 2mg n=84 for Placebo and
Slide 23: GI Safety of Larazotide in Celiac Patients
GI Safety of Larazotide in Celiac Patients (Phase 2b Study) Gastrointestinal Side Effect Reported PBO (n=84) 0.5 mg (n=85) 1 mg (n=84) 2 mg (n=87) Overall (n=256) Diarrhea 7 (8.3%) 7 (8.2%) 5 (6.0%) 8 (9.2%) 20 (7.8%) Nausea 9 (10.7%) 4 (4.7%) 7 (8.3%) 7 (8.0%) 18 (7.0%) Constipation 2 (2.4%) 3 (3.5
Slide 24: Phase 3 Primary Endpoint: CeD PRO Validated in Phase 2b
Phase 3 Primary Endpoint: CeD PRO Validated in Phase 2b • CeD PRO Abdominal Domain is the agreed upon primary endpoint for Phase 3 with the FDA • The CeD PRO was pre-specified and an exploratory endpoint in the Phase 2b Study Thinking about your worst experience in the past 24 hours, how severe was
Slide 25: Phase 3 Trial Design in Celiac Disease
Phase 3 Trial Design in Celiac Disease Screening/Eligibility Period 24-week Double-Blind Treatment Phase 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 Week 12 Week 16 Week 24 Visit 1 Visit 2 Visit 3 Visit 4 Visit 5 Visit 6 Visit 7 V
Slide 26: Investment Highlights: A Powerful Combination
Investment Highlights: A Powerful Combination NASDAQ listed company focused on rare, orphan and unmet needs in gastrointestinal disorders NM-002: Novel therapeutic approach for Short Bowel Syndrome, an underserved, debilitating orphan disease with multiple near-term data read-outs Larazotide: First
Slide 27: Thank You
Thank You John Temperato President & CEO jtemperato@9meters.com Edward Sitar Chief Financial Officer esitar@9meters.com Sireesh Appajosyula, PharmD SVP, Corporate Development & Operations sireesh@9meters.com
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