73
SECURITIES & EXCHANGE COMMISSION EDGAR FILING 9 METERS BIOPHARMA, INC. Form: 8-K Date Filed: 2021-03-23 Corporate Issuer CIK: 1551986 © Copyright 2021, Issuer Direct Corporation. All Right Reserved. Distribution of this document is strictly prohibited, subject to the terms of use.

SECURITIES & EXCHANGE COMMISSION EDGAR FILINGfilings.irdirect.net/data/1551986/000155198621000036/...2021/03/23  · Indicate by check mark whether the registrant is an emerging growth

  • Upload
    others

  • View
    3

  • Download
    0

Embed Size (px)

Citation preview

Page 1: SECURITIES & EXCHANGE COMMISSION EDGAR FILINGfilings.irdirect.net/data/1551986/000155198621000036/...2021/03/23  · Indicate by check mark whether the registrant is an emerging growth

SECURITIES & EXCHANGE COMMISSION EDGAR FILING

9 METERS BIOPHARMA, INC.

Form: 8-K

Date Filed: 2021-03-23

Corporate Issuer CIK: 1551986

© Copyright 2021, Issuer Direct Corporation. All Right Reserved. Distribution of this document is strictly prohibited, subject to the terms of use.

Page 2: SECURITIES & EXCHANGE COMMISSION EDGAR FILINGfilings.irdirect.net/data/1551986/000155198621000036/...2021/03/23  · Indicate by check mark whether the registrant is an emerging growth

version="1.0" ?>

UNITED STATESSECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

FORM 8-K

CURRENT REPORT

Pursuant to Section 13 or 15(d)of the Securities Exchange Act of 1934

Date of report (Date of earliest event reported): March 23, 2021

9 Meters Biopharma, Inc.(Exact name of registrant as specified in its charter)

Delaware 001-37797 27-3948465(State or other jurisdiction ofincorporation or organization)

(CommissionFile Number)

(I.R.S. EmployerIdentification No.)

8480 Honeycutt Road, Suite 120, Raleigh, NC 27615(Address of principal executive offices) (Zip Code)

(919) 275-1933

(Registrant’s telephone number, include area code)

N/A(Former Name or Former Address, if Changed Since Last Report)

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:

☐ Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

☐ Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

☐ Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

☐ Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

Securities registered pursuant to Section 12(b) of the Act:

Title of each class Trading Symbol(s) Name of each exchange on which registeredCommon Stock $0.0001 Par Value NMTR The Nasdaq Stock Market LLC

Indicate by check mark whether the registrant is an emerging growth company as defined in as defined in Rule 405 of the Securities Act of 1933 (§ 230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934(§ 240.12b-2 of this chapter).

EDGAR Stream is a copyright of Issuer Direct Corporation, all rights reserved.

Page 3: SECURITIES & EXCHANGE COMMISSION EDGAR FILINGfilings.irdirect.net/data/1551986/000155198621000036/...2021/03/23  · Indicate by check mark whether the registrant is an emerging growth

Emerging growth company ☒ If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section

13(a) of the Exchange Act. ☒

Item 8.01. Other Events.

On March 23, 2021, 9 Meters Biopharma, Inc. (the “Company”) updated its corporate presentation which can also be found on the Company’s website at www.9meters.com under the section titled Investors. A copy of theCompany’s presentation is attached as Exhibit 99.1 to this Current Report on Form 8-K and is incorporated by reference herein.

In addition, as previously announced on February 1, 2021, the Company will host a research and development webinar on its’ short bowel syndrome program and the results of the recently completed Phase 1b/2a clinical trialon Tuesday, March 23, 2021 at 11:00 AM Eastern Time. A copy of the presentation to be used during the webinar is attached as Exhibit 99.2 to this Current Report on Form 8-K and is incorporated by reference herein.

Item 9.01. Financial Statements and Exhibits.

(d) Exhibits

Exhibit No. DescriptionExhibit 99.1 9 Meters Biopharma, Inc. Corporate PresentationExhibit 99.2 9 Meters Biopharma, Inc. R&D Presentation

EDGAR Stream is a copyright of Issuer Direct Corporation, all rights reserved.

Page 4: SECURITIES & EXCHANGE COMMISSION EDGAR FILINGfilings.irdirect.net/data/1551986/000155198621000036/...2021/03/23  · Indicate by check mark whether the registrant is an emerging growth

SIGNATURES

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.

9 Meters Biopharma, Inc. Date: March 23, 2021 By: /s/ Edward J. Sitar Edward J. Sitar Chief Financial Officer

A Champion in GI With A One Tract Mind Focused on Rare and Unmet Needs in Gastroenterology Corporate Presentation

EDGAR Stream is a copyright of Issuer Direct Corporation, all rights reserved.

Page 5: SECURITIES & EXCHANGE COMMISSION EDGAR FILINGfilings.irdirect.net/data/1551986/000155198621000036/...2021/03/23  · Indicate by check mark whether the registrant is an emerging growth

Forward Looking Statements 2 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 relating to our future activities or other future events or conditions. These statements are based on current expectations, estimates and projections about our business based, in part, on assumptions made by management. Actual results and the timing of events could differ materially from those anticipated in such forward-looking statements as a result of these risks and uncertainties, which include, without limitation: (i) uncertainties associated with the clinical development and regulatory approval of product candidates; (ii) risks related to the inability of the Company to obtain sufficient additional capital to continue to advance these product candidates and its preclinical programs; (iii) uncertainties in obtaining successful clinical results for product candidates and unexpected costs and delays that may impact clinical development; (iv) risks related to the failure to realize any value from product candidates and preclinical programs being developed and anticipated to be developed in light of inherent risks and difficulties involved in successfully bringing product candidates to market; (v) the impact of COVID-19 on our operations, clinical trials or future financings and (vi) risks associated with the possible failure to realize certain anticipated benefits of the Company's 2020 merger and 2020 acquisition of Naia Rare Diseases, Inc., including with respect to future financial and operating results. Actual results and the timing of events could differ materially from those anticipated in such forward-looking statements because of these risks and uncertainties. These and other risks and uncertainties are more fully described in periodic filings with the SEC, including the factors described in the section entitled "Risk Factors" in the Company's Annual Report on Form 10-K for the year ended December 31, 2020 and in other filings that the Company has made and future filings the Company will make with the SEC. You should not place undue reliance on these forward-looking statements, which are made only as of the date hereof or as of

the dates indicated in the forward-looking statements. The company expressly disclaims any obligation or undertaking to release publicly any updates or revisions to any forward-looking statements contained herein to reflect any change in its expectations with regard thereto or any change in events, conditions or circumstances on which any such statements are based.

EDGAR Stream is a copyright of Issuer Direct Corporation, all rights reserved.

Page 6: SECURITIES & EXCHANGE COMMISSION EDGAR FILINGfilings.irdirect.net/data/1551986/000155198621000036/...2021/03/23  · Indicate by check mark whether the registrant is an emerging growth

Investment Highlights 3 NASDAQ listed (NMTR) focused on rare, and unmet needs in gastrointestinal disorders NM-002 Proprietary long-acting GLP-1 agonist for short bowel syndrome, with positive phase 1b/2a data with a phase 2 readout in 2021 Larazotide First drug to move into a Phase 3 trial in celiac disease with data readout in 2022 Focused on increasing shareholder value by creating solutions for GI diseases with high unmet needs through capital efficient development & commercialization pathways Leading institutional investor support

EDGAR Stream is a copyright of Issuer Direct Corporation, all rights reserved.

Page 7: SECURITIES & EXCHANGE COMMISSION EDGAR FILINGfilings.irdirect.net/data/1551986/000155198621000036/...2021/03/23  · Indicate by check mark whether the registrant is an emerging growth

Leadership Team 4 John Temperato President & CEO Edward Sitar Chief Financial Officer Patrick Griffin, MD Chief Medical Officer Sireesh Appajosyula, PharmD SVP, Corporate Development & Operations Nir Barak, MD SVP, Clinical Affairs

EDGAR Stream is a copyright of Issuer Direct Corporation, all rights reserved.

Page 8: SECURITIES & EXCHANGE COMMISSION EDGAR FILINGfilings.irdirect.net/data/1551986/000155198621000036/...2021/03/23  · Indicate by check mark whether the registrant is an emerging growth

� Capital efficient development pathway � Market protection enhancements � Capital efficient commercialization � Payer leverage � Acquire targeted clinical compounds � Agnostic within GI tract if needs are unmet � Rare & unmet needs allows for targeted patient profiling within GI 9 Meters in Circuitous Length - But a Straight-Forward Strategy 5 GI-Centric, Patient-Focused Focus Provides Rare & unmet needs in GI Develop capital efficient + regulatory predicates Commercialize efficient US footprint; strategic ROW partnerships Acquire / Partner aligned to focus

EDGAR Stream is a copyright of Issuer Direct Corporation, all rights reserved.

Page 9: SECURITIES & EXCHANGE COMMISSION EDGAR FILINGfilings.irdirect.net/data/1551986/000155198621000036/...2021/03/23  · Indicate by check mark whether the registrant is an emerging growth

9 Meters Pipeline in Rare and Unmet Need GI Diseases 6 NOTE: All programs are New Chemical Entities. NOTE: All programs are globally licensed except NM-004, which excludes Asia, except for Japan. PROGRAM INDICATION CLASS ROUTE PRE-CLINICAL PHASE 1 PHASE 2 PHASE 3 UPCOMING MILESTONES Topline readout Phase 3 → 2022 NM-002 Short Bowel Syndrome Long-Acting GLP-1 Injectable NM-003 Orphan Indication TBD Long-Acting GLP-2 Injectable NM-004 Orphan Indication TBD Immunomodulator Oral; Gut Restricted Initiate IND-enabling → 3Q21 Lead indication selection → 2021 NM-102 Orphan Indication TBD Tight Junction Microbiome Modulator Oral; Gut Restricted Larazotide Adult Celiac Disease Tight Junction Regulator Oral; Gut Restricted Initiate Phase 2 → 2Q21 Initiate Phase 3 → 4Q21 Initiate IND-enabling → 3Q21

EDGAR Stream is a copyright of Issuer Direct Corporation, all rights reserved.

Page 10: SECURITIES & EXCHANGE COMMISSION EDGAR FILINGfilings.irdirect.net/data/1551986/000155198621000036/...2021/03/23  · Indicate by check mark whether the registrant is an emerging growth

Multiple Potential Inflection Points Over Next 12-18 Months 7 • Initiate Phase 2 NM-002 trial • Obtain USAN name for NM-002 • Attendance at Digestive Disease Week (DDW) conference 2Q 2021 • Initiate IND-enabling pathway for NM-102 • Initiate IND-enabling pathway for NM-003 3Q 2021 • Topline Phase 2 readout of NM-002 trial • American College of Gastroenterology (ACG) conference abstracts/posters • Initiate Phase 3 SBS Study for NM-002 4Q 2021 • Interim analysis for larazotide Phase 3 for celiac disease • Top-line larazotide Phase 3 readout in celiac disease 2022 Evaluate rest-of-world NM-002 and global larazotide partnerships

EDGAR Stream is a copyright of Issuer Direct Corporation, all rights reserved.

Page 11: SECURITIES & EXCHANGE COMMISSION EDGAR FILINGfilings.irdirect.net/data/1551986/000155198621000036/...2021/03/23  · Indicate by check mark whether the registrant is an emerging growth

NM-002: Long-Acting GLP-1 Agonist Short Bowel Syndrome (SBS); Orphan designation

EDGAR Stream is a copyright of Issuer Direct Corporation, all rights reserved.

Page 12: SECURITIES & EXCHANGE COMMISSION EDGAR FILINGfilings.irdirect.net/data/1551986/000155198621000036/...2021/03/23  · Indicate by check mark whether the registrant is an emerging growth

9 1Jeppesen P. Expert Opin Orphan Drugs; 1:515-25; 2Transparency Market Research; Short Bowel Syndrome Market, 2019; 3Amiot A et al. Clin Nutr 2013;32:368–74; Boland E et al. Am J Surg 2010;200:690–3; 4Bielawska B. Nutrients 2017;9:466–79; Pironi L et al. Clin Nutr 2016;352:247–307; Hofstetter S et al. Curr Med Res Opin 2013;29:495–504; 5. https://www.beckershospitalreview.com/pharmacy/20-most- expensive-drugs-in-the-us.html accessed Nov. 30, 2020 Normal Length of GI Tract ~ 9.0 m / ~ 30 ft SBS Patient Length of GI Tract Significantly Shortened Short Bowel Syndrome (SBS) 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 EU1,2 • Severe disease characterized by a lack of gut motility with significant impact on quality of life • Impaired intestinal absorption, diarrhea & metabolic complications3 • Limited treatment options with dependency on parenteral support (PS) • Complex and costly parenteral nutritional support to survive; risk of life-threatening infections & extra-organ impairment4 • Gattex® (teduglutide) is a GLP-2 analogue approved in US in 2012 • ~1,400 patients under management WW • ~$600M in global sales in 2019/2020 • One of top 10 most expensive medicine in US in 2020 ~~$40,000/month)5

EDGAR Stream is a copyright of Issuer Direct Corporation, all rights reserved.

Page 13: SECURITIES & EXCHANGE COMMISSION EDGAR FILINGfilings.irdirect.net/data/1551986/000155198621000036/...2021/03/23  · Indicate by check mark whether the registrant is an emerging growth

10 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 patient’s remaining bowels to empty rapidly and frequently • Inability to absorb nutrients and fluids • Intractable diarrhea with frequent bowel movements and excessive stool output • GLP-2 analogues do not appreciably slow down the gut to affect rapid transit time associated with SBS • An ideal therapy for SBS patients should: • Be safe and tolerable, while providing convenient dosing & administration • Rapidly decrease gut motility to improve absorption of nutrients and fluids • Rapidly reduce total stool output (TSO) volume & bowel movement frequency Illustration of one phenotype of SBS with colon-in-continuity; Other phenotypes exist with and without colon-in-continuity

EDGAR Stream is a copyright of Issuer Direct Corporation, all rights reserved.

Page 14: SECURITIES & EXCHANGE COMMISSION EDGAR FILINGfilings.irdirect.net/data/1551986/000155198621000036/...2021/03/23  · Indicate by check mark whether the registrant is an emerging growth

SBS Patient Perspective on Chronic Diarrhea Indicative of Significant Impact Over the Last Decade 11 Patient quotes from NPS market research; Source: SEC 8-k April 2010 NPS Pharmaceuticals Inc. If you want a one-word description [of living with Short-Bowel Syndrome], it’s ’hell’. It changes your whole life, it ruins your life. There are ups and downs – mostly downs. It’s very difficult to manage, very difficult. I’m going so much I have no life. I can’t go anywhere – you go out anywhere you keep going to the bathroom. The bathroom is probably the most annoying thing… I always have plastic bags with me and because my bag will fill up really fast… I’ve emptied it on the subway... If you do it really fast, people have no idea what’s going on, but it’s still a pain to do.

EDGAR Stream is a copyright of Issuer Direct Corporation, all rights reserved.

Page 15: SECURITIES & EXCHANGE COMMISSION EDGAR FILINGfilings.irdirect.net/data/1551986/000155198621000036/...2021/03/23  · Indicate by check mark whether the registrant is an emerging growth

12 NM-002 (proprietary long-acting GLP-1)* GLP-2 Class Profile � Long acting GLP-1 receptor agonist � Slows gut motility � Increases time for absorption of key nutrients – GLP-2 analogue – Expand intestinal mucosa / villous growth – Limited effect on gut motility Efficacy � Improvements in total stool output volume � Improvements in bowel movement frequency � Diarrhea no longer meal-related � Reduction in nocturnal diarrhea – Must be on PS to start class of drug – Statistically significant reductions in PS volume – Very low rates of patients weaned off Onset of Action � Within hours-to-days of dosing – Weeks to months (2 to 6 months) Safety � Known target � Transient side effects � Active molecule has over 15 patient years of use – REMS program; safety concerns include: – Acceleration of neoplastic growth – Intestinal obstruction – Biliary and pancreatic disease Dosing � Evaluating weekly to up to monthly � Fixed-dosing – QD injections; newer versions once- or twice- weekly – Weight-based dosing for approved GLP-2 drug NM-002 Target Product Profile *NM-002 remains investigational and under development

EDGAR Stream is a copyright of Issuer Direct Corporation, all rights reserved.

Page 16: SECURITIES & EXCHANGE COMMISSION EDGAR FILINGfilings.irdirect.net/data/1551986/000155198621000036/...2021/03/23  · Indicate by check mark whether the registrant is an emerging growth

In a shortened bowel, motility is increased, reducing nutrient uptake and causing quicker movement of food through the bowel. Typical Short Bowel Syndrome 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. Low nutrient uptake NM-002 Replaces GLP-1 and Restores the “Ileal Brake” NM-002 rapidly replaces physiological effects of missing GLP-1 to normalize GI transit with potentially twice or once-monthly dosing.

EDGAR Stream is a copyright of Issuer Direct Corporation, all rights reserved.

Page 17: SECURITIES & EXCHANGE COMMISSION EDGAR FILINGfilings.irdirect.net/data/1551986/000155198621000036/...2021/03/23  · Indicate by check mark whether the registrant is an emerging growth

Phase 1b/2a Study: SBS Clinical Trial Design 14 Screening 50 mg cohort n = 2 100 mg Cohort n = 2 50 mg Cohort n = 1 100 mg Cohort n = 2 Total n=9 7 Day Safety Assessment 150 mg Cohort n = 1 150 mg Cohort N = 1 7 Day Safety Assessment 7 Day Safety Assessment Open label, two-dose, dose escalation study of NM-002 in adult patients with SBS NM-002 given twice, at 3 different dose levels, in 3 cohorts Doses were administered on Days 1 and 15 by subcutaneous injection. Patients followed for 6 weeks after the second dose. Main outcomes: Safety & tolerability Key secondary outcomes: Total stool output(TSO); bowel movement frequency; urine output*; parenteral support; PK Overall demographics in trial: 5m/4f (8 Caucasian) ; avg.age = 51.8 y; avg.height = 175.1 cm; avg.weight = 68.0 kg; avg.BMI = 22.1 kg.m-2 *The study protocol called for an analysis of urine output, however, it proved difficult to measure in an ambulatory setting.

EDGAR Stream is a copyright of Issuer Direct Corporation, all rights reserved.

Page 18: SECURITIES & EXCHANGE COMMISSION EDGAR FILINGfilings.irdirect.net/data/1551986/000155198621000036/...2021/03/23  · Indicate by check mark whether the registrant is an emerging growth

50 mg Cohort (n=3) 100 mg Cohort (n=4) 150 mg Cohort (n=2) Any exposure to NM-002 (n=9) System Organ Class Preferred Term # of subjects n (%) # of events n # of subjects n (%) # of events n # of subjects n (%) # of events n # of subjects n (%) # of events n TEAEs 3 (100.0) 7 3 (75.0) 6 2 (100.0) 4 8 (88.9) 17 Gastrointestinal disorders -Nausea -Vomiting 2 (66.7) 6 2 (50.0) 5 2 (100.0) 3 6 (66.7) 14 2 (66.7) 3 2 (50.0) 3 2 (100.0) 2 6 (66.7) 8 2 (66.7) 3 1 (25.0) 2 1 (50.0) 1 4 (44.4) 6 General disorders and administrative site conditions -Oedema 1 (33.3) 1 0 (0.0) 0 0 (0.0) 0 1 (11.1) 1 1 (33.3) 1 0 (0.0) 0 0 (0.0) 0 1 (11.1) 1 Nervous system disorders -Dizziness 0 (0.0) 0 0 (0.0) 0 1 (50.0) 1 1 (11.1) 1 0 (0.0) 0 0 (0.0) 0 1 (50.0) 1 1 (11.1) 1 Skin and subcutaneous tissue disorders -Rash 0 0 1 (25.0) 1 0 (0.0) 0 1 (11.1) 1 0 0 1 (25.0) 1 0 (0.0) 0 1 (11.1) 1 15 Phase 1b/2a Trial: Treatment Emergent Adverse Events NM-002 was generally safe and well tolerated: 17 treatment-emergent adverse events (TEAEs) were observed in 9 patients, 15 of which were mild, transient and self-limited without further intervention. The majority of TEAEs were GI-related (nausea and vomiting).

EDGAR Stream is a copyright of Issuer Direct Corporation, all rights reserved.

Page 19: SECURITIES & EXCHANGE COMMISSION EDGAR FILINGfilings.irdirect.net/data/1551986/000155198621000036/...2021/03/23  · Indicate by check mark whether the registrant is an emerging growth

Patient NM-002 Dose (mg) Baseline (mL) First 48 Hours Post Dose 1 (mL) Change from Baseline (mL) First 48 Hours Post Dose 2 (mL) Change from Baseline (mL) 1 50 22508 12550 −9958 13950 −8558 2 50 1900 200 −1700 300 −1600 61 50 1175 350 −825 - - 3 100 720 615 −105 325 −395 4 100 1285 420 -865 24502 1165 5 100 2280 2000 −280 1940 −340 7 100 5390 3010 -2380 2600 -2790 8 150 2570 2150 -420 1480 -1090 9 150 4850 3900 -950 3000 -1850 16 Phase 1b/2a Efficacy: Total Stool Output (TSO) Lasting effect seen in patients, confirming single ascending dose T2DM study data (Cleland, et. al.) 1. Patient 06 did not receive a 2nd dose. 2. The baseline prior to the second dose in this patient was substantially higher than the original baseline volume due to rapid increase in oral intake.

EDGAR Stream is a copyright of Issuer Direct Corporation, all rights reserved.

Page 20: SECURITIES & EXCHANGE COMMISSION EDGAR FILINGfilings.irdirect.net/data/1551986/000155198621000036/...2021/03/23  · Indicate by check mark whether the registrant is an emerging growth

Summary of Study Results 17 Study met its primary objective: NM-002 demonstrated an excellent safety and tolerability profile NM-002 demonstrated a clinically relevant improvement in total stool output (TSO) volume, supporting a clear “GO” decision for next phase of development Data support twice monthly fixed dosing regimen (or better) Rapid improvement in clinically relevant efficacy outcomes1: • All 9 patients showed meaningful reduction in total stool output volume within 48 hours of first dose -Average TSO reduction of 42% from baseline in all 9 patients at 48 hours post dose 1 • Efficacy seen with 1st dose carried through to 2nd dose at Day 15 -Average TSO reduction of 46% from baseline in 7/8 patients within 48 hours post dose 22 • Bowel movement frequency: 4/7 after receiving 1 dose and 5/6 after receiving 2 doses had reductions • Parenteral support: 2 of 5 patients on PS in this trial had reduction after each dose • Quality of life: SF-36 data suggests overall improvements in general well-being in this trial 1. Given the size of the study population, note that the trial was not powered for efficacy analyses. 2. Excludes 1 patient that did not receive a 2nd dose, and another patient that had substantial increase in oral intake prior to 2nd dose.

EDGAR Stream is a copyright of Issuer Direct Corporation, all rights reserved.

Page 21: SECURITIES & EXCHANGE COMMISSION EDGAR FILINGfilings.irdirect.net/data/1551986/000155198621000036/...2021/03/23  · Indicate by check mark whether the registrant is an emerging growth

FDA Response on Planned Phase 2 Program 18 Secondary endpoints will include parenteral requirements, diarrhea impact, meal-related stool output, nocturnal stool output, sleep quality and quality of life FDA Type C meeting communication supports plan to initiate Phase 2 study with NM-002 for SBS using Total Stool Output (TSO) as the primary efficacy outcome measure Multi-center, double-blind, double-dummy, randomized placebo-controlled trial; FDA has provided global anchor questions and specific guidance for performance of exit interviews to support clinical meaningfulness of observed efficacy

EDGAR Stream is a copyright of Issuer Direct Corporation, all rights reserved.

Page 22: SECURITIES & EXCHANGE COMMISSION EDGAR FILINGfilings.irdirect.net/data/1551986/000155198621000036/...2021/03/23  · Indicate by check mark whether the registrant is an emerging growth

Proposed NM-002 Study Design & Timeline 19 Group n Treatment Day 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 finalized: 5 (primary) + 1 (backup) • Timeline: study initiation on target for 2Q 2021

EDGAR Stream is a copyright of Issuer Direct Corporation, all rights reserved.

Page 23: SECURITIES & EXCHANGE COMMISSION EDGAR FILINGfilings.irdirect.net/data/1551986/000155198621000036/...2021/03/23  · Indicate by check mark whether the registrant is an emerging growth

Larazotide: Oral, Non-Absorbable Tight-Junction Regulator Celiac Disease

EDGAR Stream is a copyright of Issuer Direct Corporation, all rights reserved.

Page 24: SECURITIES & EXCHANGE COMMISSION EDGAR FILINGfilings.irdirect.net/data/1551986/000155198621000036/...2021/03/23  · Indicate by check mark whether the registrant is an emerging growth

Celiac Disease: Autoimmune Disorder with a Genetic Link 21 1 Schuppan and Dieterich, UpTo Date (2018) 2 Fasano, A. Genetics of Celiac Disease (Nov 2019) https://emedicine.medscape.com/article/1790189-overview 3 Withoff, S., Li, Y., Jonkers, I. and Wijmenga, C., 2016. Trends in Genetics, 32(5), pp.295-308 GI Abdominal Domain Symptoms Abdominal Pain Abdominal Cramps Bloating Gas US & EU ~1% US ~3.2 million EU ~3.5 million ROW ~15 million Prevalence 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 patients have a specific HLA class II gene variant2 � HLA-DQ2 (~95%) or, � HLA-DQ8 (5%)2 • Genome-Wide Association Studies (GWAS) link disease to four genes involved with regulation of tight junctions3 Gluten Free Diet (GFD) is the only therapy • Nutritional imbalances • Cost burden to patients

EDGAR Stream is a copyright of Issuer Direct Corporation, all rights reserved.

Page 25: SECURITIES & EXCHANGE COMMISSION EDGAR FILINGfilings.irdirect.net/data/1551986/000155198621000036/...2021/03/23  · Indicate by check mark whether the registrant is an emerging growth

Larazotide Normalizes Intestinal Barrier in Celiac Disease 22

EDGAR Stream is a copyright of Issuer Direct Corporation, all rights reserved.

Page 26: SECURITIES & EXCHANGE COMMISSION EDGAR FILINGfilings.irdirect.net/data/1551986/000155198621000036/...2021/03/23  · Indicate by check mark whether the registrant is an emerging growth

Phase 2: PRO Endpoints Show Robust Treatment Effect 23 1CeD PRO Abdominal Domain is the agreed upon endpoint for phase 3 with the FDA. The CeD PRO was pre-specified & an exploratory endpoint in the Phase 2b Study 2Responder ≈Subject has 50% improvement vs. baseline CeD-PRO abdominal score (6/12 weeks) Leffler, DA, Kelly, CP, Green, PHR et al. Gastroenterology 2015;148:1311–1319 FDA Drug Labels for Xifaxan® (Salix/Bausch), Viberzi® (Allergan), Linzess® (Allergan/Ironwood), Amitiza® (Takeda/Sucampo) and Trulance® (Synergy/Salix/Bausch) Dose 0.5mg 1mg 2mg CeD GSRS1 p values 0.022 0.900 0.590 28.6% 14.3% 10.0% 20.0% 30.0% p = 0.022 0.0% % R es po nd er s* 14.3% Treatment Effect n=84 for Placebo and n=84 for 0.5 mg dose Placebo 0.50mg Treatment effect > than approved IBS brands with Phase 3 PROsPositive Phase 2b with Statistically Significant p Value at Therapeutic Dose (Xifaxan®, Viberzi®, Linzess®, Amitiza®, and Trulance®) CeD PRO1 Responder2 Analysis P2b TrialCeD-GSRS: Primary Endpoint for Phase 2b

EDGAR Stream is a copyright of Issuer Direct Corporation, all rights reserved.

Page 27: SECURITIES & EXCHANGE COMMISSION EDGAR FILINGfilings.irdirect.net/data/1551986/000155198621000036/...2021/03/23  · Indicate by check mark whether the registrant is an emerging growth

Screening/Eligibility Period 12-week Double-Blind Treatment Phase Primary Endpoint Analyzed at Week 12 12-week Double-Blind Safety Phase Phase 3 Trial Design in Celiac Disease (n = 525) 24 1 Primary Endpoint: CeD Pro Abdominal Domain1 at 12 Weeks Mean change from baseline for celiac disease symptom severity based on CeD PRO symptom scores (continuous variable) 2 Key Inclusion Criteria Similar to Phase 2b -Adults with celiac disease -Gluten free diet symptoms monitored -Include patients with symptoms despite a GFD 3 Phase 3 De-Risked Based on Phase 2b Learnings -Exclude subjects likely to do well on a GFD -Enriched design includes patients with greater severity to increase treatment effect Day 35 Week 5 Visit 1 Day 168 ± 3 Week 24 Visit 8 (End) Day 21 Week 3 Visit 2 Day 1 Baseline Visit 3 Day 28 ± 3 Week 4 Visit 4 Day 56 ± 3 Week 8 Visit 5 Day 84 ± 3 Week 12 Visit 6 Day 112 ± 3 Week 16 Visit 7 1CeD PRO Abdominal Domain = abdominal cramping, abdominal pain, bloating and gas ; ClinicalTrials.gov Identifier: NCT03569007 Placebo (~n = 175) Larazotide 0.25 mg TID (~n = 175) Larazotide 0.50 mg TID (~n = 175) Initiate Double-Blind Study Drug on Day 1 Randomization 1:1:1

EDGAR Stream is a copyright of Issuer Direct Corporation, all rights reserved.

Page 28: SECURITIES & EXCHANGE COMMISSION EDGAR FILINGfilings.irdirect.net/data/1551986/000155198621000036/...2021/03/23  · Indicate by check mark whether the registrant is an emerging growth

April Obtain NM-002 USAN name Near Term Inflection Points 25 March 23 9 Meters SBS R & D Day -Full data set review 2020 2021 2Q21 Phase 2 initiation -22 patient trial starts 4Q21 Topline NM-002 Phase 2 results American College of Gastroenterology (ACG) conference 2022 Interim analysis for larazotide Phase 3 for celiac disease December Topline NM-002 Phase 1b/2a results May Digestive Disease Week (DDW) conference 3Q21 Initiate IND-enabling pathway for NM-102 & NM-003 2022 Top-line larazotide phase 3 readout 2022 4Q21 Initiate phase 3 SBS NM-002 study

EDGAR Stream is a copyright of Issuer Direct Corporation, all rights reserved.

Page 29: SECURITIES & EXCHANGE COMMISSION EDGAR FILINGfilings.irdirect.net/data/1551986/000155198621000036/...2021/03/23  · Indicate by check mark whether the registrant is an emerging growth

Thank You John Temperato President & CEO [email protected] Edward Sitar Chief Financial Officer [email protected] 8480 Honeycutt Road, Suite 120 Raleigh, NC 27615 Telephone: 1-919-275-1933 [email protected] www.9meters.com Twitter LinkedIn

EDGAR Stream is a copyright of Issuer Direct Corporation, all rights reserved.

Page 30: SECURITIES & EXCHANGE COMMISSION EDGAR FILINGfilings.irdirect.net/data/1551986/000155198621000036/...2021/03/23  · Indicate by check mark whether the registrant is an emerging growth

EDGAR Stream is a copyright of Issuer Direct Corporation, all rights reserved.

Page 31: SECURITIES & EXCHANGE COMMISSION EDGAR FILINGfilings.irdirect.net/data/1551986/000155198621000036/...2021/03/23  · Indicate by check mark whether the registrant is an emerging growth

A Champion in GI With A One Tract Mind Focused on Rare and Unmet Needs in Gastroenterology Short Bowel Syndrome R&D Day NM-002: Proprietary Long-Acting GLP-1 Agonist March 23, 2021

EDGAR Stream is a copyright of Issuer Direct Corporation, all rights reserved.

Page 32: SECURITIES & EXCHANGE COMMISSION EDGAR FILINGfilings.irdirect.net/data/1551986/000155198621000036/...2021/03/23  · Indicate by check mark whether the registrant is an emerging growth

Forward Looking Statements 2 This presentation 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 relating to our future activities or other future events or conditions. These statements are based on current expectations, estimates and projections about our business based, in part, on assumptions made by management. Actual results and the timing of events could differ materially from those anticipated in such forward-looking statements as a result of these risks and uncertainties, which include, without limitation: (i) uncertainties associated with the clinical development and regulatory approval of product candidates; (ii) risks related to the inability of the Company to obtain sufficient additional capital to continue to advance these product candidates and its preclinical programs; (iii) uncertainties in obtaining successful clinical results for product candidates and unexpected costs and delays that may impact clinical development; (iv) risks related to the failure to realize any value from product candidates and preclinical programs being developed and anticipated to be developed in light of inherent risks and difficulties involved in successfully bringing product candidates to market; (v) the impact of COVID-19 on our operations, clinical trials or future financings and (vi) risks associated with the possible failure to realize certain anticipated benefits of the Company's 2020 merger and 2020 acquisition of Naia Rare Diseases, Inc., including with respect to future financial and operating results. Actual results and the timing of events could differ materially from those anticipated in such forward-looking statements because of these risks and uncertainties. These and other risks and uncertainties are more fully described in periodic filings with the SEC, including the factors described in the section entitled "Risk Factors" in the Company's Annual Report on Form 10-K for the year ended December 31, 2020 and in other filings that the Company has made and future filings the Company will make with the SEC. You should not place undue reliance on these forward-looking statements, which are made only as of the date hereof or as of

the dates indicated in the forward-looking statements. The company expressly disclaims any obligation or undertaking to release publicly any updates or revisions to any forward-looking statements contained herein to reflect any change in its expectations with regard thereto or any change in events, conditions or circumstances on which any such statements are based.

EDGAR Stream is a copyright of Issuer Direct Corporation, all rights reserved.

Page 33: SECURITIES & EXCHANGE COMMISSION EDGAR FILINGfilings.irdirect.net/data/1551986/000155198621000036/...2021/03/23  · Indicate by check mark whether the registrant is an emerging growth

R&D Day Agenda • Introduction - John Temperato, President & CEO • Short Bowel Syndrome Overview & Management – Patrick H. Griffin, MD, CMO • Clinical Impact of Chronic Diarrhea in SBS Patients – Carol Rees Parrish, MS, RDN, University of Virginia Health System • Paradigm Shift to GLP-1 – Patrick H. Griffin, MD, CMO • Phase 1b/2a Results Update and Recap – Patrick H. Griffin, MD, CMO • Clinical & Regulatory Path Forward – Patrick H. Griffin, MD, CMO • Question & Answer Session 3

EDGAR Stream is a copyright of Issuer Direct Corporation, all rights reserved.

Page 34: SECURITIES & EXCHANGE COMMISSION EDGAR FILINGfilings.irdirect.net/data/1551986/000155198621000036/...2021/03/23  · Indicate by check mark whether the registrant is an emerging growth

Introduction John Temperato, President and CEO

EDGAR Stream is a copyright of Issuer Direct Corporation, all rights reserved.

Page 35: SECURITIES & EXCHANGE COMMISSION EDGAR FILINGfilings.irdirect.net/data/1551986/000155198621000036/...2021/03/23  · Indicate by check mark whether the registrant is an emerging growth

� Capital efficient development pathway � Market protection enhancements � Capital efficient commercialization � Payer leverage � Acquire targeted clinical compounds � Agnostic within GI tract if needs are unmet � Rare & unmet needs allows for targeted patient profiling within GI 9 Meters in Circuitous Length - But a Straight-Forward Strategy 5 GI-Centric, Patient-Focused Focus Provides Rare & unmet needs in GI Develop capital efficient + regulatory predicates Commercialize efficient US footprint; strategic ROW partnerships Acquire / Partner aligned to focus

EDGAR Stream is a copyright of Issuer Direct Corporation, all rights reserved.

Page 36: SECURITIES & EXCHANGE COMMISSION EDGAR FILINGfilings.irdirect.net/data/1551986/000155198621000036/...2021/03/23  · Indicate by check mark whether the registrant is an emerging growth

9 Meters Pipeline in Rare and Unmet Need GI Diseases 6 NOTE: All programs are New Chemical Entities. NOTE: All programs are globally licensed except NM-004, which excludes Asia, except for Japan. PROGRAM INDICATION CLASS ROUTE PRE-CLINICAL PHASE 1 PHASE 2 PHASE 3 UPCOMING MILESTONES Topline readout Phase 3 → 2022 NM-002 Short Bowel Syndrome Long-Acting GLP-1 Injectable NM-003 Orphan Indication TBD Long-Acting GLP-2 Injectable NM-004 Orphan Indication TBD Immunomodulator Oral; Gut Restricted Initiate IND-enabling → 3Q21 Lead indication selection → 2021 NM-102 Orphan Indication TBD Tight Junction Microbiome Modulator Oral; Gut Restricted Larazotide Adult Celiac Disease Tight Junction Regulator Oral; Gut Restricted Initiate Phase 2 → 2Q21 Initiate Phase 3 → 4Q21 Initiate IND-enabling → 3Q21

EDGAR Stream is a copyright of Issuer Direct Corporation, all rights reserved.

Page 37: SECURITIES & EXCHANGE COMMISSION EDGAR FILINGfilings.irdirect.net/data/1551986/000155198621000036/...2021/03/23  · Indicate by check mark whether the registrant is an emerging growth

Multiple Potential Inflection Points Over Next 12-18 Months 7 • Initiate Phase 2 NM-002 trial • Obtain USAN name for NM-002 • Attendance at Digestive Disease Week (DDW) conference 2Q 2021 • Initiate IND-enabling pathway for NM-102 • Initiate IND-enabling pathway for NM-003 3Q 2021 • Topline Phase 2 readout of NM-002 trial • American College of Gastroenterology (ACG) conference abstracts/posters • Initiate Phase 3 SBS trial for NM-002 4Q 2021 • Interim analysis for larazotide Phase 3 for celiac disease • Top-line larazotide Phase 3 readout in celiac disease 2022 Evaluate rest-of-world NM-002 and global larazotide partnerships

EDGAR Stream is a copyright of Issuer Direct Corporation, all rights reserved.

Page 38: SECURITIES & EXCHANGE COMMISSION EDGAR FILINGfilings.irdirect.net/data/1551986/000155198621000036/...2021/03/23  · Indicate by check mark whether the registrant is an emerging growth

8 1Jeppesen P. Expert Opin Orphan Drugs; 1:515-25; 2Transparency Market Research; Short Bowel Syndrome Market, 2019 Normal Length of GI Tract ~ 9.0 m / ~ 30 ft SBS Patient Length of GI Tract Significantly Shortened Short Bowel Syndrome (SBS) is a Debilitating Orphan Disease • Orphan disease (orphan designation granted) with an underserved market • Affects up to 20,000 people in the U.S. with similar prevalence in Europe1,2 • Gattex® (teduglutide) is a GLP-2 analogue approved in US in 2012 • ~1,400 patients under management WW • ~$600M in global sales in 2019/2020 • 10th most expensive medicine in US in 2020 ($40,000 per month)

EDGAR Stream is a copyright of Issuer Direct Corporation, all rights reserved.

Page 39: SECURITIES & EXCHANGE COMMISSION EDGAR FILINGfilings.irdirect.net/data/1551986/000155198621000036/...2021/03/23  · Indicate by check mark whether the registrant is an emerging growth

9 NM-002 (proprietary long-acting GLP-1)* GLP-2 Class Profile � Long acting GLP-1 receptor agonist � Slows gut motility � Increases time for absorption of key nutrients – GLP-2 analogue – Expand intestinal mucosa / villous growth – Limited effect on gut motility Efficacy � Improvements in total stool output volume � Improvements in bowel movement frequency � Diarrhea no longer meal-related � Reduction in nocturnal diarrhea – Must be on PS to start class of drug – Statistically significant reductions in PS volume – Very low rates of patients weaned off Onset of Action � Within hours-to-days of dosing – Weeks to months (2 to 6 months) Safety � Known target � Transient side effects � Active molecule has over 15 patient years of use – REMS program; safety concerns include: – Acceleration of neoplastic growth – Intestinal obstruction – Biliary and pancreatic disease Dosing � Evaluating weekly to up to monthly � Fixed-dosing – QD injections; newer versions once- or twice- weekly – Weight-based dosing for approved GLP-2 drug NM-002 Target Product Profile *NM-002 remains investigational and under development

EDGAR Stream is a copyright of Issuer Direct Corporation, all rights reserved.

Page 40: SECURITIES & EXCHANGE COMMISSION EDGAR FILINGfilings.irdirect.net/data/1551986/000155198621000036/...2021/03/23  · Indicate by check mark whether the registrant is an emerging growth

Patrick H. Griffin MD, FACP – Chief Medical Officer Dr. Griffin became our chief medical officer in February 2019. Previously, Dr. Griffin served as executive vice president and chief medical officer of Synergy Pharmaceuticals from January 2015 through November 2018, and senior vice president and chief medical officer May 2013 through January 2015. From March 2012 to April 2013, Dr. Griffin served as chief medical officer and senior vice president of development at ImmusanT, Inc. From March 2009 until January 2012, Dr. Griffin served as associate vice president, clinical development and head of external innovation at Sanofi-Aventis (now Sanofi). He is a board-certified physician in both internal medicine and gastroenterology, and is a Fellow of the American College of Physicians. He received his medical degree from Columbia University, completing a residency in internal medicine at Presbyterian Hospital in New York, and a fellowship in gastroenterology at Brigham and Women’s Hospital in Boston. Following his residency and fellowship, Dr. Griffin joined the medical faculty of Columbia College of Physicians and Surgeons, where he held a number of academic, clinical research, teaching and management positions, and a private practice in New York. 10

EDGAR Stream is a copyright of Issuer Direct Corporation, all rights reserved.

Page 41: SECURITIES & EXCHANGE COMMISSION EDGAR FILINGfilings.irdirect.net/data/1551986/000155198621000036/...2021/03/23  · Indicate by check mark whether the registrant is an emerging growth

Short Bowel Syndrome Overview & Management Patrick H. Griffin, MD, FACP, CMO

EDGAR Stream is a copyright of Issuer Direct Corporation, all rights reserved.

Page 42: SECURITIES & EXCHANGE COMMISSION EDGAR FILINGfilings.irdirect.net/data/1551986/000155198621000036/...2021/03/23  · Indicate by check mark whether the registrant is an emerging growth

12 1Amiot A et al. Clin Nutr 2013;32:368–74; Boland E et al. Am J Surg 2010;200:690–3; 2Bielawska B. Nutrients 2017;9:466–79; Pironi L et al. Clin Nutr 2016;352:247–307; Hofstetter S et al. Curr Med Res Opin 2013;29:495– 504. 3 Jeppesen 2014 Normal Length of GI Tract ~ 9.0 m / ~ 30 ft SBS Patient Length of GI Tract Significantly Shortened Short Bowel Syndrome (SBS) is a Debilitating Orphan Disease • Severe disease characterized by a near-complete lack of gut motility with significant impact on quality of life • Impaired intestinal absorption, diarrhea & metabolic complications1 • Limited treatment options with potential life-long dependency on parenteral support (PS) • Complex and costly parenteral nutritional support to survive; risk of life-threatening infections & extra- organ impairment2 • Typical SBS patient etiology3: ‒ Irreversible inflammatory bowel disease ‒ Motor vehicle accident ‒ Atherosclerotic heart disease of mesentery circulation ‒ Congenital disease

EDGAR Stream is a copyright of Issuer Direct Corporation, all rights reserved.

Page 43: SECURITIES & EXCHANGE COMMISSION EDGAR FILINGfilings.irdirect.net/data/1551986/000155198621000036/...2021/03/23  · Indicate by check mark whether the registrant is an emerging growth

SBS Patient Perspective on Chronic Diarrhea Indicative of Significant Impact Over the Last Decade 13 Patient quotes from NPS market research; Source: SEC 8-k April 2010 NPS Pharmaceuticals Inc. If you want a one-word description [of living with Short-Bowel Syndrome], it’s ’hell’. It changes your whole life, it ruins your life. There are ups and downs – mostly downs. It’s very difficult to manage, very difficult. I’m going so much I have no life. I can’t go anywhere – you go out anywhere you keep going to the bathroom. The bathroom is probably the most annoying thing… I always have plastic bags with me and because my bag will fill up really fast… I’ve emptied it on the subway... If you do it really fast, people have no idea what’s going on, but it’s still a pain to do.

EDGAR Stream is a copyright of Issuer Direct Corporation, all rights reserved.

Page 44: SECURITIES & EXCHANGE COMMISSION EDGAR FILINGfilings.irdirect.net/data/1551986/000155198621000036/...2021/03/23  · Indicate by check mark whether the registrant is an emerging growth

Treatment Options: Nutrition and Hydration • Absorption capacity for nutrition, fluid, and electrolytes is proportional to: ‒ Length of small bowel ‒ Segments of the intact bowel ‒ Absorptive quality of remnant bowel ‒ Individual capacity for GI mucosal adaptation • PN/IV support provides the nutrition, fluid, and electrolytes necessary to maintain health and body weight • IV fluids and electrolytes are required due to fluid loss • Two years after bowel resection, PN/IV dependence is 49%, decreasing only slightly at 5 years to 45% 14 Tappenden KA. J Parenter Enteral Nutr. 2014;38(1 Suppl):23S-31S.; Jeppesen PB. J Parenter Enteral Nutr. 2014;38(1 Suppl):8S-13S.; Messing B et al. Gastroenterology. 1999 Nov;117(5):1043-50.

EDGAR Stream is a copyright of Issuer Direct Corporation, all rights reserved.

Page 45: SECURITIES & EXCHANGE COMMISSION EDGAR FILINGfilings.irdirect.net/data/1551986/000155198621000036/...2021/03/23  · Indicate by check mark whether the registrant is an emerging growth

15 Treatment Options: GLP-2 Mechanism of Drug Class Trophic gut peptide increases villous height and crypt depth Control GLP-2 Murine model of GLP-2 effects on gastrointestinal villus/crypt architecture adapted from Drucker DJ, Erlich P, et al. Proc Natl Acad Sci U S A. 1996; 93:7911. National Academy of Sciences, USA NutrientsEndotoxins Bacterial Metabolites L Cell IEL GLP- 1 GLP- 1 GLP- 2 Enterocyte GLP- 1R Intestinal Mucosal Epithelium Gut Lumen Approved therapy: • GLP-2 class to promote intestinal growth (teduglutide approved in US in 2012, long-acting analogues in development) • All GLP-2 analogues have the same mechanism likely requiring long- term treatment to achieve significant benefit • Clinically relevant reduction in PS volume with GLP-2s is delayed

EDGAR Stream is a copyright of Issuer Direct Corporation, all rights reserved.

Page 46: SECURITIES & EXCHANGE COMMISSION EDGAR FILINGfilings.irdirect.net/data/1551986/000155198621000036/...2021/03/23  · Indicate by check mark whether the registrant is an emerging growth

Treatment Options: Supportive Care • SBS supportive symptom care: ‒ Growth hormone and glutamine (approved) ‒ Antidiarrheals: loperamide, diphenoxylate/atropine, diluted tincture of opium, codeine ‒ Antiemetics for chronic nausea (e.g. 5HT3 antagonists) ‒ Acid suppressors: PPI, H2RA ‒ Antibiotics: small intestinal bacterial overgrowth ‒ Bile acid sequestering agents • Surgical augmentation and intestinal transplant – for specific cases 16

EDGAR Stream is a copyright of Issuer Direct Corporation, all rights reserved.

Page 47: SECURITIES & EXCHANGE COMMISSION EDGAR FILINGfilings.irdirect.net/data/1551986/000155198621000036/...2021/03/23  · Indicate by check mark whether the registrant is an emerging growth

17 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 patient’s remaining bowels to empty rapidly and frequently • Inability to absorb nutrients and fluids • Intractable diarrhea with frequent bowel movements and excessive stool output • GLP-2 analogues do not appreciably slow down the gut to affect rapid transit time associated with SBS • An ideal therapy for SBS patients should: • Be safe and tolerable, while providing convenient dosing & administration • Rapidly decrease gut motility to improve absorption of nutrients and fluids • Rapidly reduce total stool output (TSO) volume & bowel movement frequency Illustration of one phenotype of SBS with colon-in-continuity; Other phenotypes exist with and without colon-in-continuity

EDGAR Stream is a copyright of Issuer Direct Corporation, all rights reserved.

Page 48: SECURITIES & EXCHANGE COMMISSION EDGAR FILINGfilings.irdirect.net/data/1551986/000155198621000036/...2021/03/23  · Indicate by check mark whether the registrant is an emerging growth

Speaker: Carol Rees Parrish, MS, RDN Carol Parrish has 30 years of clinical experience, the past 20 of which have been spent specializing in nutrition support and GI disorders at the University of Virginia Health System (UVAHS), Digestive Health Center of Excellence. Carol founded the Medicine Nutrition Support Service in 1991, began the home nutrition support program at the UVAHS Home Health Company, developed the GI Nutrition Clinic, originated our Celiac Support Group, and is the co-founder of both nutrition support traineeship programs. She has been the nutrition series editor for the popular Practical Gastroenterology Journal’s Nutrition Series since 2003. Previously, she was a clinical nutritionist at Fairfax Hospital from 1981-1990 and a nutrition counselor at multiple practices from 1984-1990. Ms. Parrish received her Bachelor of Science from the University of California, Davis, and a Master of Science from Rosalind Franklin University of Medicine and Science. She completed her general internship at Milwaukee County Medical Complex. In addition to being a member of many professional affiliations, Ms. Parrish has written multiple abstracts, chapters, and publications. 18

EDGAR Stream is a copyright of Issuer Direct Corporation, all rights reserved.

Page 49: SECURITIES & EXCHANGE COMMISSION EDGAR FILINGfilings.irdirect.net/data/1551986/000155198621000036/...2021/03/23  · Indicate by check mark whether the registrant is an emerging growth

The Clinical Impact of Chronic Diarrhea Importance in SBS Patients Carol Rees Parrish, MS, RDN University of Virginia

EDGAR Stream is a copyright of Issuer Direct Corporation, all rights reserved.

Page 50: SECURITIES & EXCHANGE COMMISSION EDGAR FILINGfilings.irdirect.net/data/1551986/000155198621000036/...2021/03/23  · Indicate by check mark whether the registrant is an emerging growth

UVA Health Available at no cost to patients & clinicians @ www.shortbowelsyndrome.com under “sign up at top” NOTE: New 2021 version will be available this summer 20

EDGAR Stream is a copyright of Issuer Direct Corporation, all rights reserved.

Page 51: SECURITIES & EXCHANGE COMMISSION EDGAR FILINGfilings.irdirect.net/data/1551986/000155198621000036/...2021/03/23  · Indicate by check mark whether the registrant is an emerging growth

Paradigm Shift to GLP-1 NM-002: Proprietary Long-Acting GLP-1 Agonist Patrick H. Griffin, MD, FACP, CMO

EDGAR Stream is a copyright of Issuer Direct Corporation, all rights reserved.

Page 52: SECURITIES & EXCHANGE COMMISSION EDGAR FILINGfilings.irdirect.net/data/1551986/000155198621000036/...2021/03/23  · Indicate by check mark whether the registrant is an emerging growth

Why is a paradigm shift needed? • Chronic diarrhea due to malabsorption in SBS has not been fully addressed with current treatments. • Relief from incessant diarrhea continues to be a high unmet need and requires a solution for all SBS patients, independent of parenteral requirements. • NM-002 is a proprietary long-acting GLP-1 agonist which may address the root cause of this unmet need. 22

EDGAR Stream is a copyright of Issuer Direct Corporation, all rights reserved.

Page 53: SECURITIES & EXCHANGE COMMISSION EDGAR FILINGfilings.irdirect.net/data/1551986/000155198621000036/...2021/03/23  · Indicate by check mark whether the registrant is an emerging growth

In a shortened bowel, motility is increased, reducing nutrient uptake and causing quicker movement of food through the bowel. Typical Short Bowel Syndrome 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. Low nutrient uptake NM-002 Replaces GLP-1 and Restores the “Ileal Brake” NM-002 rapidly replaces physiological effects of missing GLP-1 to normalize GI transit with potentially twice or once-monthly dosing. 23

EDGAR Stream is a copyright of Issuer Direct Corporation, all rights reserved.

Page 54: SECURITIES & EXCHANGE COMMISSION EDGAR FILINGfilings.irdirect.net/data/1551986/000155198621000036/...2021/03/23  · Indicate by check mark whether the registrant is an emerging growth

24 Asp HisGly Thr ThrSerPheGluGly Asp Leu Ser LysGlnMetGluGluAlaVal GluArg Phe Leu Ile GluTrpLeu ProLys GlyGly Ser Ser Gly GlyAlaProProSer • Dipeptidyl peptidase 4 cleaves native GLP- 1 and GLP-2 in minutes • Exenatide still limited by half-life (2.5 h) • Long-acting depot formulation (Bydureon®) not optimized for SBS • NM-002 is created in recombinant process via technology licensed from Amunix • XTENylation process is a recombinant protein engineering method to fuse protein polymers using a limited number of AAs Exenatide 4.2 kDa XTENylation Key Benefits: • Increases exenatide half-life from 2 to ~170 h in PK modelling • Not PEGylation conjugation • Fully recombinant process • Increased drug stability • Reduced immunogenicity • Fully biodegradable • Defined chemical structure • Purifiable drug product • Manufacturing known and scalable • Clinically validated: Human PoC using exenatide-XTEN completed; multiple other targets also completed clinical studies in > 200 patients NM-002 80 kDa Source: Amunix Pharmaceuticals, Inc. Mountain View, CA; ORI – origin of replication; KANR – Kanamycin resistance gene NM-002 is XTENylated™ Creating Ultra-Long Half-Life

EDGAR Stream is a copyright of Issuer Direct Corporation, all rights reserved.

Page 55: SECURITIES & EXCHANGE COMMISSION EDGAR FILINGfilings.irdirect.net/data/1551986/000155198621000036/...2021/03/23  · Indicate by check mark whether the registrant is an emerging growth

25 NM-002 Pharmacokinetics Supports Target Product Profile All parameters are mean values. 1. One 50 mg dose patient did not receive a 2nd dose Source: Pharmacokinetic data from NM-002 Phase 1b/2a trial in short bowel syndrome Day Parameter 50 mg Cohort (n=3) 100 mg Cohort (n=4) 150 mg Cohort (n=2) 1 Mean AUC0-t (h*ng/mL) 1481465.77 2849924.89 2651203.79 Mean Cmax (ng/mL) 13893.92 24894.00 24347.01 Mean Tmax (h) 144 150 168 Day Parameter 50 mg Cohort (n=2)1 100 mg Cohort (n=4) 150 mg Cohort (n=2) 15 Mean AUC0-t (h*ng/mL) 5151279.93 11558003.89 15518762.38 Mean Cmax (ng/mL) 19067.26 46097.44 58973.28 Mean Tmax (h) 84.0 108 84.0 Se ru m c on ce nt ra tio n (n g/ m L) NM-002 50 mg NM-002 100 mg NM-002 150 mg

EDGAR Stream is a copyright of Issuer Direct Corporation, all rights reserved.

Page 56: SECURITIES & EXCHANGE COMMISSION EDGAR FILINGfilings.irdirect.net/data/1551986/000155198621000036/...2021/03/23  · Indicate by check mark whether the registrant is an emerging growth

Short Bowel Syndrome NM-002 Phase 1b/2a Results Patrick H. Griffin, MD, FACP, CMO

EDGAR Stream is a copyright of Issuer Direct Corporation, all rights reserved.

Page 57: SECURITIES & EXCHANGE COMMISSION EDGAR FILINGfilings.irdirect.net/data/1551986/000155198621000036/...2021/03/23  · Indicate by check mark whether the registrant is an emerging growth

Phase 1b/2a Study: SBS Clinical Trial Design 27 Screening 50 mg cohort n = 2 100 mg Cohort n = 2 50 mg Cohort n = 1 100 mg Cohort n = 2 Total n=9 7 Day Safety Assessment 150 mg Cohort n = 1 150 mg Cohort N = 1 7 Day Safety Assessment 7 Day Safety Assessment Open label, two-dose, dose escalation study of NM-002 in adult patients with SBS NM-002 given twice, at 3 different dose levels, in 3 cohorts Doses were administered on Days 1 and 15 by subcutaneous injection. Patients followed for 6 weeks after the second dose. Main outcomes: Safety & tolerability Key secondary outcomes: Total stool output(TSO); bowel movement frequency; urine output*; parenteral support; PK Overall demographics in trial: 5m/4f (8 Caucasian) ; avg.age = 51.8 y; avg.height = 175.1 cm; avg.weight = 68.0 kg; avg.BMI = 22.1 kg.m-2 *The study protocol called for an analysis of urine output, however, it proved difficult to measure in an ambulatory setting.

EDGAR Stream is a copyright of Issuer Direct Corporation, all rights reserved.

Page 58: SECURITIES & EXCHANGE COMMISSION EDGAR FILINGfilings.irdirect.net/data/1551986/000155198621000036/...2021/03/23  · Indicate by check mark whether the registrant is an emerging growth

50 mg Cohort (n=3) 100 mg Cohort (n=4) 150 mg Cohort (n=2) Any exposure to NM-002 (n=9) System Organ Class Preferred Term # of subjects n (%) # of events n # of subjects n (%) # of events n # of subjects n (%) # of events n # of subjects n (%) # of events n TEAEs 3 (100.0) 7 3 (75.0) 6 2 (100.0) 4 8 (88.9) 17 Gastrointestinal disorders -Nausea -Vomiting 2 (66.7) 6 2 (50.0) 5 2 (100.0) 3 6 (66.7) 14 2 (66.7) 3 2 (50.0) 3 2 (100.0) 2 6 (66.7) 8 2 (66.7) 3 1 (25.0) 2 1 (50.0) 1 4 (44.4) 6 General disorders and administrative site conditions -Oedema 1 (33.3) 1 0 (0.0) 0 0 (0.0) 0 1 (11.1) 1 1 (33.3) 1 0 (0.0) 0 0 (0.0) 0 1 (11.1) 1 Nervous system disorders -Dizziness 0 (0.0) 0 0 (0.0) 0 1 (50.0) 1 1 (11.1) 1 0 (0.0) 0 0 (0.0) 0 1 (50.0) 1 1 (11.1) 1 Skin and subcutaneous tissue disorders -Rash 0 0 1 (25.0) 1 0 (0.0) 0 1 (11.1) 1 0 0 1 (25.0) 1 0 (0.0) 0 1 (11.1) 1 28 Phase 1b/2a Trial: Treatment Emergent Adverse Events NM-002 was generally safe and well tolerated: 17 treatment-emergent adverse events (TEAEs) were observed in 9 patients, 15 of which were mild, transient and self-limited without further intervention. The majority of TEAEs were GI-related (nausea and vomiting).

EDGAR Stream is a copyright of Issuer Direct Corporation, all rights reserved.

Page 59: SECURITIES & EXCHANGE COMMISSION EDGAR FILINGfilings.irdirect.net/data/1551986/000155198621000036/...2021/03/23  · Indicate by check mark whether the registrant is an emerging growth

Patient NM-002 Dose (mg) Baseline (mL) First 48 Hours Post Dose 1 (mL) Change from Baseline (mL) First 48 Hours Post Dose 2 (mL) Change from Baseline (mL) 1 50 22508 12550 −9958 13950 −8558 2 50 1900 200 −1700 300 −1600 61 50 1175 350 −825 - - 3 100 720 615 −105 325 −395 4 100 1285 420 -865 24502 1165 5 100 2280 2000 −280 1940 −340 7 100 5390 3010 -2380 2600 -2790 8 150 2570 2150 -420 1480 -1090 9 150 4850 3900 -950 3000 -1850 29 Phase 1b/2a Efficacy: Total Stool Output (TSO) Lasting effect seen in patients, confirming single ascending dose T2DM study data (Cleland, et. al.) 1. Patient 06 did not receive a 2nd dose. 2. The baseline prior to the second dose in this patient was substantially higher than the original baseline volume due to rapid increase in oral intake.

EDGAR Stream is a copyright of Issuer Direct Corporation, all rights reserved.

Page 60: SECURITIES & EXCHANGE COMMISSION EDGAR FILINGfilings.irdirect.net/data/1551986/000155198621000036/...2021/03/23  · Indicate by check mark whether the registrant is an emerging growth

Patients 1 & 3 have an ostomy, therefore missing from the bowel frequency table; total stool output (previous slide) more relevant in these patients 30 Phase 1b/2a Efficacy: Bowel Movement Frequency Patient NM-002 Dose (mg) Baseline (#) First 48 Hours Post Dose 1 (#) Change from Baseline (#) First 48 Hours Post Dose 2 (#) Change from Baseline (#) 2 50 22 1 −21 4 −18 61 50 5 8 3 - - 4 100 20 20 0 10 −10 5 100 8 11 3 13 5 7 100 22 17 -5 10 -12 8 150 12 9 -3 9 -3 9 150 13 9 -4 8 -5 1. Patient 06 did not receive a 2nd dose

EDGAR Stream is a copyright of Issuer Direct Corporation, all rights reserved.

Page 61: SECURITIES & EXCHANGE COMMISSION EDGAR FILINGfilings.irdirect.net/data/1551986/000155198621000036/...2021/03/23  · Indicate by check mark whether the registrant is an emerging growth

Urine Output Unreliable In This Ambulatory Setting Trial 31 To date, urine output has not been an efficacy endpoint for any SBS development program and there are currently no plans to use this as an end measure in our go-forward clinical and regulatory path.

EDGAR Stream is a copyright of Issuer Direct Corporation, all rights reserved.

Page 62: SECURITIES & EXCHANGE COMMISSION EDGAR FILINGfilings.irdirect.net/data/1551986/000155198621000036/...2021/03/23  · Indicate by check mark whether the registrant is an emerging growth

Parenteral Support: Data from 2/5* Patients on NM-002 After Only Two Doses 32 *5 of 9 total patients in the trial were on PS; the remaining 3 patients (not shown) had no worsening of PS values and were stable on baseline PS

EDGAR Stream is a copyright of Issuer Direct Corporation, all rights reserved.

Page 63: SECURITIES & EXCHANGE COMMISSION EDGAR FILINGfilings.irdirect.net/data/1551986/000155198621000036/...2021/03/23  · Indicate by check mark whether the registrant is an emerging growth

SF-36 Quality of Life Questionnaire Results 33 Results of the SF-36 Quality of Life instrument show directional improvement in multiple elements of health status over the course of this study.

EDGAR Stream is a copyright of Issuer Direct Corporation, all rights reserved.

Page 64: SECURITIES & EXCHANGE COMMISSION EDGAR FILINGfilings.irdirect.net/data/1551986/000155198621000036/...2021/03/23  · Indicate by check mark whether the registrant is an emerging growth

Summary of Study Results 34 Study met its primary objective: NM-002 demonstrated an excellent safety and tolerability profile NM-002 demonstrated a clinically relevant improvement in total stool output (TSO) volume, supporting a clear “GO” decision for next phase of development Data support twice monthly fixed dosing regimen (or better) Rapid improvement in clinically relevant efficacy outcomes1: • All 9 patients showed meaningful reduction in total stool output volume within 48 hours of first dose -Average TSO reduction of 42% from baseline in all 9 patients at 48 hours post dose 1 • Efficacy seen with 1st dose carried through to 2nd dose at Day 15 -Average TSO reduction of 46% from baseline in 7/8 patients within 48 hours post dose 22 • Bowel movement frequency: 4/7 after receiving 1 dose and 5/6 after receiving 2 doses had reductions • Parenteral support: 2 of 5 patients on PS in this trial had reduction after each dose • Quality of life: SF-36 data suggests overall improvements in general well-being in this trial 1. Given the size of the study population, note that the trial was not powered for efficacy analyses. 2. Excludes 1 patient that did not receive a 2nd dose, and another patient that had substantial increase in oral intake prior to 2nd dose.

EDGAR Stream is a copyright of Issuer Direct Corporation, all rights reserved.

Page 65: SECURITIES & EXCHANGE COMMISSION EDGAR FILINGfilings.irdirect.net/data/1551986/000155198621000036/...2021/03/23  · Indicate by check mark whether the registrant is an emerging growth

Clinical and Regulatory Path Forward Patrick H. Griffin, MD, FACP, CMO

EDGAR Stream is a copyright of Issuer Direct Corporation, all rights reserved.

Page 66: SECURITIES & EXCHANGE COMMISSION EDGAR FILINGfilings.irdirect.net/data/1551986/000155198621000036/...2021/03/23  · Indicate by check mark whether the registrant is an emerging growth

FDA Response on Planned Phase 2 Program 36 Secondary endpoints will include parenteral requirements, diarrhea impact, meal-related stool output, nocturnal stool output, sleep quality and quality of life FDA Type C meeting communication supports plan to initiate Phase 2 study with NM-002 for SBS using Total Stool Output (TSO) as the primary efficacy outcome measure Multi-center, double-blind, double-dummy, randomized placebo-controlled trial; FDA has provided global anchor questions and specific guidance for performance of exit interviews to support clinical meaningfulness of observed efficacy

EDGAR Stream is a copyright of Issuer Direct Corporation, all rights reserved.

Page 67: SECURITIES & EXCHANGE COMMISSION EDGAR FILINGfilings.irdirect.net/data/1551986/000155198621000036/...2021/03/23  · Indicate by check mark whether the registrant is an emerging growth

Goals of Phase 2 Trial • Remote trial execution in Covid-19 environment (Telehealth, remote outcome assessments, e.g., oral intake & TSO) • Remote outcome measurements ‒ stool output volume ‒ oral intake volume ‒ body weight ‒ vital signs, etc. • Identify most efficacious, safe dose compared to placebo • Confirm target patient population (parenteral support not a requirement) 37

EDGAR Stream is a copyright of Issuer Direct Corporation, all rights reserved.

Page 68: SECURITIES & EXCHANGE COMMISSION EDGAR FILINGfilings.irdirect.net/data/1551986/000155198621000036/...2021/03/23  · Indicate by check mark whether the registrant is an emerging growth

Proposed NM-002 Study Design & Timeline 38 Group n Treatment Day 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 finalized: 5 (primary) + 1 (backup) • Timeline: study initiation on target for 2Q 2021

EDGAR Stream is a copyright of Issuer Direct Corporation, all rights reserved.

Page 69: SECURITIES & EXCHANGE COMMISSION EDGAR FILINGfilings.irdirect.net/data/1551986/000155198621000036/...2021/03/23  · Indicate by check mark whether the registrant is an emerging growth

Managing the Phase 2 Program During Covid-19 39 • Data collection considerations • Training, communication and management of the trial team • Patient recruitment • Patient retention during the trial • Managing investigational drug product & matching placebo • Patient study sample management • Monitoring & audit of study • Study close-out, completion & data analysis

EDGAR Stream is a copyright of Issuer Direct Corporation, all rights reserved.

Page 70: SECURITIES & EXCHANGE COMMISSION EDGAR FILINGfilings.irdirect.net/data/1551986/000155198621000036/...2021/03/23  · Indicate by check mark whether the registrant is an emerging growth

Informing the NM-002 Phase 3 SBS Clinical Program 40 Based on current data we project a double-blind treatment period of 12 weeks enrolling 80-100 patients followed by adequate long-term safety timeline to be determined. teduglutide (approved) glepaglutide (Phase 3 investigational agent) apraglutide (phase 3 investigational agent) Phase 3 patient number 173 129 144 Duration of double- blind treatment 24 weeks 24 weeks 48 weeks (efficacy at 24 weeks) No. of groups 2 (1 drug/1 pbo) 3 (2 drug/1 pbo) 2 (1 drug/1 pbo) Duration of safety extension 30 months 2 Years* N/A Source: Gattex® Prescribing Information; *Clinicaltrials.gov accessed March 18, 2021

EDGAR Stream is a copyright of Issuer Direct Corporation, all rights reserved.

Page 71: SECURITIES & EXCHANGE COMMISSION EDGAR FILINGfilings.irdirect.net/data/1551986/000155198621000036/...2021/03/23  · Indicate by check mark whether the registrant is an emerging growth

April Pending USAN Name NM-002 Near Term Inflection Points 41 March 23 9 Meters SBS R & D Day -Full data set review 2020 2021 2Q21 Phase 2 initiation -22 patient trial starts 4Q21 Topline Phase 2 results 4Q21 Phase 3 SBS study initiation Early December Topline Phase 1b/2a results

EDGAR Stream is a copyright of Issuer Direct Corporation, all rights reserved.

Page 72: SECURITIES & EXCHANGE COMMISSION EDGAR FILINGfilings.irdirect.net/data/1551986/000155198621000036/...2021/03/23  · Indicate by check mark whether the registrant is an emerging growth

Thank You John Temperato President & CEO [email protected] Edward Sitar Chief Financial Officer [email protected] 8480 Honeycutt Road, Suite 120 Raleigh, NC 27615 Telephone: 1-919-275-1933 [email protected] www.9meters.com Twitter LinkedIn

EDGAR Stream is a copyright of Issuer Direct Corporation, all rights reserved.

Page 73: SECURITIES & EXCHANGE COMMISSION EDGAR FILINGfilings.irdirect.net/data/1551986/000155198621000036/...2021/03/23  · Indicate by check mark whether the registrant is an emerging growth

EDGAR Stream is a copyright of Issuer Direct Corporation, all rights reserved.