0001551986FALSE00015519862022-03-232022-03-23

UNITED STATES
SECURITIES 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, 2022
 
 
 
9 Meters Biopharma, Inc.
(Exact name of registrant as specified in its charter)
 
 
 
Delaware 001-37797 27-3948465
(State or other jurisdiction of
incorporation or organization)
 (Commission
File Number)
 (I.R.S. Employer
Identification 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 classTrading Symbol(s)Name of each exchange on which registered
Common Stock $0.0001 Par ValueNMTRThe 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).
 



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 2.02.Results of Operations and Financial Condition.
On March 23, 2022, 9 Meters Biopharma, Inc. (the "Company") issued a press release providing a business update and announcing financial results for the fourth quarter and full year 2021. A copy of such release is attached as Exhibit 99.1 to this Current Report on Form 8-K and is incorporated by reference herein.

Pursuant to General Instruction B.2 of Current Report on Form 8-K, the information contained in, or incorporated into, Item 2.02, including the press release attached as Exhibit 99.1, is being furnished and shall not be deemed “filed” for the purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities of that section, nor shall it be deemed incorporated by reference into any registration statement or other filing under the Securities Act of 1933, as amended, or the Exchange Act, except as shall be expressly set forth by specific reference to such filing.

Item 8.01.Other Events.

On March 23, 2022, 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 the Company's presentation 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.Description
Exhibit 99.1
Exhibit 99.2
Exhibit 104Cover Page Interactive Data File (embedded within the Inline XBRL document).






  
 




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, 2022By: /s/ Bethany Sensenig
   Bethany Sensenig
   Chief Financial Officer
 
 
 
 

 

 
 
 


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9 Meters Biopharma Provides Business Update and Reports Financial Results
for Fourth Quarter and Full Year 2021

Phase 2 topline vurolenatide data for short bowel syndrome anticipated in Q2 2022

Phase 3 larazotide interim analysis for celiac disease anticipated in early June 2022

Executive team strengthened with appointment of highly experienced professionals, including Chief Financial Officer, Chief Commercial Officer, and SVP of Investor Relations & Corporate Communications

Year-ending cash of $47.0 million is expected to fund ongoing clinical programs and business operations into Q2 2023

Raleigh, NC, March 23, 2022 – 9 Meters Biopharma, Inc. (Nasdaq: NMTR), a clinical-stage company pioneering novel treatments for people with rare or debilitating digestive diseases, today provided an overview of its recent achievements, important upcoming milestones, and financial results for the fourth quarter and full year ended December 31, 2021.

John Temperato, President & CEO of 9 Meters Biopharma, commented: “2021 was an exceptionally productive year for 9 Meters as we significantly advanced our pipeline, particularly our lead assets vurolenatide for short bowel syndrome (SBS) and larazotide for celiac disease. We look forward to meaningful data readouts in the second quarter of this year for both, and we believe these readouts will drive our partnership and licensing discussions forward. We are also excited to have bolstered our executive management team with three senior hires at the start of 2022, which position the company well for future growth. Finally, we ended 2021 with $47.0 million in cash, providing cash runway to fund operations into the second quarter of 2023.”

Clinical Development and Business Highlights

Vurolenatide Phase 2 Trial for SBS progressing toward topline data in Q2 2022:
Our Phase 2 trial known as VIBRANT (VurolenatIde for short Bowel syndrome Regardless of pArenteral support requiremeNT) is a multicenter, double-blind, placebo-controlled parallel group study evaluating the safety, efficacy, and tolerability of vurolenatide in adult patients with SBS.
Following disruption in staffing and operations at study sites due to the Omicron surge in late 2021 and early 2022, all study sites are now open and active. Top-line data is expected in the second quarter of this year.
Following topline data, the Company expects to hold an end-of-Phase 2 meeting with the FDA and subsequently be in a position to dose the first patient in our Phase 3 U.S. registration study as early as the third quarter of this year.
The Company awarded an unrestricted educational grant to Carol Rees Parrish, M.S., RDN, a GI Nutrition Support Specialist, to launch a new educational website, SBSCurbside.org. The service will allow Carol, who has longstanding expertise in caring for patients with SBS, to provide clinicians help and education when caring for their SBS patients.

Larazotide Phase 3 Trial for Celiac Disease interim analysis anticipated in early June:

Our Phase 3 trial, referred to as CedLara® (Celiac disease Larazotide), is a randomized, double-blind, placebo-controlled study to evaluate the safety and efficacy of larazotide in patients with


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celiac disease who continue to experience gastrointestinal (GI) symptoms while following a gluten-free diet.
On February 28, 2022, 9 Meters announced that the study reached the cut-off for the pre-specified interim analysis with 50% of the target study population randomized.
The interim analysis should be completed in early June when approximately 50% of subjects have completed 12 weeks of double-blind treatment.

Larazotide Phase 2a study for multisystem inflammatory syndrome in children (MIS-C) resulting from COVID-19 is ongoing. Topline data is expected in 2H 2022:

The randomized, double-blind, placebo-controlled Phase 2 study is the product of a collaboration with the European Biomedical Research Institute of Salerno, Italy (EBRIS), which is conducting this study.
Encouraging data was published in the journal Critical Care Explorations on the use of larazotide to treat pediatric patients with MIS-C resulting from COVID-19. The four patients in the case study, ages 3 to 17, experienced significantly faster resolution of GI symptoms and their hospital stays were slightly shorter numerically on average compared to children who did not receive larazotide. Additionally, serum levels of the SARS-CoV-2 spike protein diminished to undetectable levels within one day on average in children treated with larazotide, versus ten days for children not treated with larazotide.

Executive team strengthened by adding individuals with exceptionally strong experience across the biotechnology industry and in the public markets:

Bethany Sensenig, MBA, CMA, as Chief Financial Officer, with over twenty years of business and strategic financial leadership experience at both early-stage and large biotechnology companies. Ms. Sensenig comes to 9 Meters with CFO and operations experience from Minovia Therapeutics, and notably, spent thirteen years at Biogen, Inc., where she held several positions of increasing responsibility, the latest of which was Vice President of Finance and Commercial Operations.
Sarah Liu, MBA, as Chief Commercial Officer, with deep commercialization and strategic planning experience in the rare disease space. Ms. Liu comes to 9 Meters from Novartis Gene Therapies, where she was the Vice President and Head of Worldwide New Product Planning and Vice President, Global Marketing, leading the development of the global commercial strategy for ZOLGENSMA®.
Al Medwar, MBA, as Senior Vice President, Investor Relations & Corporate Communications with extensive investor relations and corporate development expertise. Mr. Medwar has over 30 years of pharmaceutical experience and for 12 years led corporate and business development, marketing and investor and public relations at BioDelivery Sciences through the transition of the company from a development stage to a commercial entity with multiple marketed products.

Pre-Clinical Pipeline Update

NM-102 (proprietary tight-junction microbiome modulator):

Announced a collaboration agreement with Gustave Roussy, a leading cancer center in France. Gustave Roussy is expanding on the preclinical research showing that NM-102 was effective when combined with immune checkpoint inhibitors (ICIs) in a mouse model of aggressive skin melanoma, and in combination, improved survival compared to ICIs alone.
Received notice from the United States Patent and Trademark Office that U.S. Patent Application No. 17/239.056 has been allowed. The patent demonstrates that NM-102 can improve the benefit of ICIs for cancer treatment.


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Announced collaboration with NYU Langone Health investigating the pre-clinical use of NM-102 for an undisclosed autoimmune condition with a large unmet need.

NM-136 (anti-GIP hu-mAb):

Progressing into IND-enabling work in 2022 for the treatment of rare obesity disorders.

NM-003 (proprietary long-acting GLP-2 agonist):

Planning is underway for IND-enabling work.

Full Year and Fourth Quarter Financial Results

As of December 31, 2021, the Company’s cash and cash equivalents totaled approximately $47.0 million, compared to approximately $37.9 million as of December 31, 2020.

The Company reported a net loss of approximately $9.6 million, or $0.04 per share, for the fourth quarter of 2021, compared to a net loss of approximately $5.0 million, or $0.03 per share for the fourth quarter of 2020. This increase was primarily due to the advancement of our clinical development programs. The Company reported a net loss of approximately $36.8 million, or $0.15 per share, for the year ended December 31, 2021, compared to a net loss of approximately $61.5 million, or $0.58 per share, for the year ended December 31, 2020. The decrease was primarily related to costs of the merger and acquisition of RDD Pharma and Naia Rare Diseases, of which the majority was non-cash acquired in-process research and development expenses. The Company anticipates its cash runway is sufficient to fund the ongoing clinical programs and business operations into second quarter of 2023.

Key Anticipated 2022 Milestones

Phase 2 topline data for vurolenatide in SBS in Q2 2022
Phase 3 interim analysis for larazotide in celiac disease in early June 2022
Vurolenatide R&D Day (post end-of-Phase 2 meeting with FDA)
First patient dosed in vurolenatide Phase 3 study for SBS could be as early as Q3 2022
Phase 2a data for larazotide in MIS-C in 2H 2022

About 9 Meters Biopharma

9 Meters Biopharma, Inc. is a clinical-stage company pioneering novel treatments for people with rare digestive diseases, gastrointestinal conditions with unmet needs, and debilitating disorders in which the biology of the gut is a contributing factor. The Company is advancing vurolenatide, a proprietary Phase 2 long-acting GLP-1 agonist, for short bowel syndrome (SBS); larazotide, a Phase 3 tight junction regulator in non-responsive celiac disease; and a robust pipeline of early-stage assets.

For more information, please visit www.9meters.com or follow 9 Meters on Twitter and LinkedIn.



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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, anticipated milestones and 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 various risks and uncertainties, which include, without limitation: the impact of COVID-19 on our operations, enrollment in and timing of clinical trials; reliance on research and development partners; uncertainties associated with the clinical development and regulatory approval of product candidates; uncertainties in obtaining successful clinical results for product candidates and unexpected costs that may result therefrom; 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; risks related to cybersecurity and data privacy; intellectual property risks; risks related to the inability of the Company to obtain sufficient additional capital to continue to advance these product candidates and its preclinical programs, including in light of current stock market conditions; risk of delisting from Nasdaq; reliance on collaborators; and risks associated with acquiring and developing additional compounds. 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, 2021, 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.

Corporate Contact

Al Medwar
SVP, Investor Relations & Corporate Communications
9 Meters Biopharma, Inc.
investor-relations@9meters.com
www.9meters.com

Media Contact

Veronica Eames
LifeSci Communications, LLC
veames@lifescicomms.com
203-942-4626






Pioneering Novel Treatments with a one-tract mind FOCUSED ON RARE AND UNMET NEEDS IN DIGESTIVE DISEASES AND UNIQUE GI B IOLOGY


 
forward-looking statements 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, anticipated milestones and 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 various risks and uncertainties, which include, without limitation: the impact of COVID-19 on our operations, enrollment in and timing of clinical trials; reliance on research and development partners; uncertainties associated with the clinical development and regulatory approval of product candidates; uncertainties in obtaining successful clinical results for product candidates and unexpected costs that may result therefrom; 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; risks related to the inability of the Company to obtain sufficient additional capital to continue to advance these product candidates and its preclinical programs; reliance on collaborators; and risks associated with acquiring and developing additional compounds. 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, Form 10-Q for the quarter ended September 30, 2021, 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. 2


 
Changing the world through novel therapeutic approaches that treat people with rare and debilitating conditions via unique gut related pathways. vision changing the world for patients mission Developing innovative treatments to liberate patients from rare and underserved diseases through our deep understanding of GI biology. 3


 
investor highlights 9 meters at a glance Focused on rare and unmet needs in digestive diseases and untapped GI biology vurolenatide Proprietary long-acting GLP-1 agonist for short bowel syndrome, with positive phase 1b/2a data and a Phase 2 readout in 2Q22 larazotide First drug to move into a Phase 3 trial in celiac disease with data readout in 2022 a straight-forward strategy Creating solutions across key gut-related pathways with high unmet needs through capital efficient development & commercialization pathways 4 leading institutional investor support Joined the broad-market Russell 3000® Index and the small-cap Russell 2000® Index covered by leading health care analysts Nasdaq listed: NMTR


 
John Temperato PRESIDENT & CHIEF EXECUTIVE OFFICER Bethany Sensenig, MBA, CMA CHIEF FINANCIAL OFFICER Patrick H. Griffin, MD CHIEF MEDICAL OFFICER Sireesh Appajosyula, PharmD SVP, CORPORATE DEVELOPMENT & OPERATIONS Nir Barak, MD SVP, SCIENTIFIC AFFAIRS Matthew D. Bryant, PharmD VP, MEDICAL AFFAIRS Sarah Liu, MBA CHIEF COMMERCIAL OFFICER Al Medwar, MBA SVP, INVESTOR RELATIONS & CORPORATE COMMUNICATIONS leadership team 5


 
develop capital efficient & regulatory predicates acquire/ partner aligned to focus commercialize efficient US footprint; strategic ROW partnerships rare, unmet needs & unique GI biology digestive disease-centric, patient-focused • Acquire targeted clinical compounds • Agnostic within GI tract if needs are unmet • Rare & unmet needs allow for targeted patient profiling focus provides • Capital efficient development pathways • Market protection enhancements • Capital efficient commercialization • Payer leverage 9 meters in circuitous length BUT A STRAIGHT-FORWARD STRATEGY 6


 
NOTE: All programs are New Chemical Entities. NOTE: All programs are globally licensed except NM-004, which excludes Asia, except for Japan. *MIS-C = multisystem inflammatory syndrome in children clinical trial in collaboration with European Biomedical Research Institute of Salerno (EBRIS); GLP-1 = glucagon-like peptide-1; GLP-2 = glucagon-like peptide-2; GIP = glucose-dependent insulinotropic polypeptide; hu-mAb = humanized monoclonal antibody pipeline – one tract with multiple meaningful opportunities 7 PROGRAM Indication CLASS ROUTE PRE-CLINICAL PHASE 1 PHASE 2 PHASE 3 MILESTONES Phase 3 interim analysis → 2Q 2022 Vurolenatide Short Bowel Syndrome Long-Acting GLP-1 Injectable NM-003 Orphan Indication TBD Long-Acting GLP-2 Injectable IND-enabling planning underway NM-102 Orphan Indication TBD Tight Junction Microbiome Modulator Oral Larazotide Adult Celiac Disease Tight Junction Regulator Oral; Gut Restricted Phase 2 topline data → 2Q 2022 IND-enabling underway NM-136 Targeted Obesity Disorders NM-004 Orphan Indication TBD Immunomodulator Oral; Gut Restricted Injectable Phase 2 ready IND-enabling underwayAnti-GIP hu-mAb Larazotide MIS-C* Tight Junction Regulator Oral; Gut Restricted Phase 2a topline data → 2H 2022


 
multiple potential inflection points through 2022 Evaluate rest-of-world vurolenatide and global larazotide partnerships 3Q 2021 Initiated IND-enabling pathway for NM-102 Initiated IND-enabling pathway for NM-003 Acquired and initiated IND-enabling pathway for NM-136 4Q 2021 Initiated larazotide Phase 2a MIS-C trial Initiated NM-003 pre- clinical PoC Initiated NM-102 collaboration with Gustave Roussy 1H 2022 Vurolenatide (SBS) Phase 2 trial topline data in 2Q SBS R & D Day post FDA End-of-Phase 2 meeting Larazotide (CeD) Phase 3 trial interim analysis in 2Q 2H 2022 8 Vurolenatide (SBS) Phase 3 trial first patient dosed in 3Q Larazotide (MIS-C) Phase 2a trial data Larazotide (CeD) Phase 3 trial topline data NM-102, NM-136 progression of IND-enabling work


 
vurolenatide: long-acting glp-1 agonist Short Bowel Syndrome (SBS); Orphan Designation 9


 
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 EU1,2 • Severe disease characterized by impaired gut motility with significant impact on quality of life • Impaired intestinal absorption, diarrhea & metabolic complications3,4 • Limited treatment options with dependency on parenteral support (PS) • Complex and costly parenteral nutritional support to survive; risk of life-threatening infections & extra-organ impairment5-7 • Approximately half of patients do not require parenteral support8-10 • Gattex® (teduglutide) is a GLP-2 analogue approved in US in 2012 • ~1,500 patients under management WW • ~$600M in global sales in 2020 • 11th most expensive medicine in US in 2021 ~$41,000/month11 normal Length of GI Tract ~9.0 m/~30 ft sbs patient Length of GI Tract Significantly Shortened 1. Jeppesen P. Expert Opin Orphan Drugs. 2013;1(7):515-525. 2. Transparency Market Research; Short Bowel Syndrome Market. 2019. 3. Amiot A et al. Clin Nutr. 2013;32:368-374. 4. Boland E et al. Am J Surg. 2010;200:690-693. 5. Bielawska B. Nutrients. 2017;9:466-479. 6. Pironi L et al. Clin Nutr. 2016;352:247-307. 7. Hofstetter S et al. Curr Med Res Opin. 2013;29:495-504. 8. Tappenden KA. J Parenter Enteral Nutr. 2014;38(1 Suppl):23S-31S. 9. Jeppesen PB. J Parenter Enteral Nutr. 2014;38(1 Suppl):8S-13S. 10. Messing B et al. Gastroenterology. 1999;117(5):1043-1050. 11. Becker Health Hospital Review, February 8, 2021. 10


 
patients with sbs typically have compromised levels of glp-1 Illustration of one phenotype of SBS with colon-in-continuity; Other phenotypes exist with and without colon-in-continuity 11 • 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, causing an SBS patient’s remaining bowels to empty rapidly and frequently • Inability to absorb nutrients and fluids • Intractable, malabsorptive diarrhea with frequent bowel movements and excessive stool output • Production of natural GLP-1 is compromised in patients with SBS • Portion of the ileum secreting GLP-1 may be removed during resection • GLP-2 analogues do not appreciably slow motility to affect rapid GI transit time associated with SBS • An ideal therapy for SBS patients should: • Be safe and tolerable, while providing convenient dosing and administration • Rapidly decrease gut motility to improve absorption of nutrients and fluids • Rapidly reduce total stool output (TSO) volume and bowel movement frequency


 
vurolenatidereplaces glp-1 and restores the “ileal brake” 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. Vurolenatide rapidly replaces physiological effects of missing GLP-1 to normalize GI transit with potentially twice- or once-monthly dosing. XTEN R Molecule is an NCE through recombinantly derived process exenatide ~4.2 kDa Asp HisGly Thr ThrSerPheGluGly Asp Leu Ser LysGlnMetGluGluAlaVal GluArg Phe Leu Ile GluTrpLeu ProLys GlyGly Ser Ser Gly GlyAlaProProSer vurolenatide ~80 kDa + 12


 
reasons to believe vurolenatide has the potential to advance the way we treat sbs *Vurolenatide remains investigational and under development. 13


 
phase 1b/2a study: sbs clinical trial design *The study protocol called for an analysis of urine output; however, it proved difficult to measure in an ambulatory setting. open label, 2-dose, dose-escalation study of vurolenatide in adult patients with sbs Vurolenatide given twice, at 3 different dose levels, in 3 cohorts Doses were administered on Days 1 and 15 by subcutaneous injection. MAIN OUTCOMES: Safety & tolerability Key secondary outcomes: Total stool output (TSO) volume; bowel movement frequency; urine output*; parenteral support; PK Patients were followed for 6 weeks after the second dose. Screening 50 mg cohort n=2 50 mg cohort n=1 100 mg cohort n=2 100 mg cohort n=2 150 mg cohort n=1 150 mg cohort n=1 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/m2 14


 
phase 1b/2a trial: treatment-emergent adverse events Vurolenatide was generally safe and well tolerated: 17 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). 15


 
phase 1b/2a efficacy: total stool output (tso) *Patient 6 did not receive a second dose. †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. lasting effect seen in patients, confirming single ascending dose t2dm study data (cleland et al.) 16


 
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 twice-monthly fixed-dosing regimen (or better) Rapid improvement in clinically relevant efficacy outcomes*: • 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 2† • 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 suggest overall improvements in general well-being in this trial *Given the size of the study population, note that the trial was not powered for efficacy analyses. †Excludes 1 patient who did not receive a 2nd dose, and another patient who had substantial increase in oral intake prior to 2nd dose. 17


 
fda response on initiated 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 has provided global anchor questions and specific guidance for performance of exit interviews to support clinical meaningfulness of observed efficacy Secondary endpoints will include diarrhea impact, nocturnal stool output, meal-related stool output, parenteral requirements, sleep quality, and quality of life 18


 
VIBRANT: phase 2 sbs trial design & timeline (n = 22) Site selection finalized: 5 primary + 2 backup Timeline: topline results expected 1Q22 50 mg PBO Group 1 n=6 Group 2 n=6 Group 3 n=6 Group 4 n=4 Study population: all comers (regardless of phenotype and/or PS requirement) 50 mg PBO 50 mg 100 mg PBO 100 mg PBO 100 mg 50 mg 50 mg 50 mg 50 mg 50 mg PBO PBO PBO PBO PBO DAY 0 DAY 7 DAY 14 DAY 21 DAY 28 VIBRANT = VurolenatIde for short Bowel syndrome Regardless of pArenteral support requiremeNT; PS = parenteral support.19


 
larazotide: oral, non-absorbed tight-junction regulator Celiac Disease; Fast-track Designation 20


 
• Worldwide prevalence of around 1% and on the rise2 • Celiac patients have a specific HLA class II gene variant3 • HLA-DQ2 (~95%) or • HLA-DQ8 (5%)4 • Genome-Wide Association Studies (GWAS) link disease to 4 genes involved with regulation of tight junctions4 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 malnutrition, osteoporosis, neurologic complaints, lymphoma and gastrointestinal cancers1 Abdominal Pain Abdominal Cramps Bloating Flatulence GI Abdominal Domain Symptoms celiac disease: autoimmune disorder with a clear unmet need 1.) Kurien, M. et al. Long-term care for patients with celiac disease in the UK: a review of the literature and future directions. J Hum Nutr Diet 2016; 29- 617-623. 2.) Schuppan and Dieterich, UpTo Date (2018). 3.) Fasano A. Genetics of Celiac Disease (Nov 2019) https://emedicine.medscape.com/article/1790189-overview. 4.) Withoff S et al. Trends Genet. 2016;32(5):295-308. Genetic link


 
celiac disease: genetically- inked autoimmune disorder with no pharmacotherapy options CeD global prevalence: ~1% of the population worldwide and growing1,2 Gluten-free diet (GFD) is the only treatment option • Even those on a gluten-free diet suffer from symptoms, often consume gluten inadvertently and have evidence of intestinal damage3 Patient journey is long, expensive and frustrating • Time elapsed between initial symptoms and diagnosis: ~ 6–10 years4; many patients are misdiagnosed initially4 • Mean PPPY healthcare costs are higher for CeD patients vs. controls ($3,465–$7,921 higher per year over a three-year measurement period)6 “Living with Celiac Disease Is exhausting, just because I'm sick all the time. Being sick every day takes the life out of me.” 6 - Age: 35/ Gluten-Free: 10 years United States ~3.2 million adult patients EU4 + UK + Northern Europe ~3.5 million adult patients 1. Schupan and Dietrich, Up to Date (2018) . 2. Singh et al. Global prevalence of celiac disease; systematic review and meta-analysis. Clin Gastroenterology and Hepatology 2018; 16: 823-836 3. Silvester, J. et al. Most patients with Celiac Disease on gluten-free diets consume measurable amounts of gluten. Gastroenterology 202 April 158(5): 1497-1499 4. Beyondceliac.org 5. Capell, K. et al. Healthcare resource utilization and costs in Celiac Disease: a US claims analysis. AM J Gastroenterol 2020; 115:1821-1829. 6. Short Bowel Syndrome & Celiac Disease testimonial qualitative study, November 2021 Global Prevalence: ~21MM adult patients 22


 
larazotideimproves intestinal barrier integrity in celiac disease 22


 
phase 2: pro endpoints show robust treatment effect Placebo 0.50 mg 28.6% 14.3% 10.0% 20.0% 30.0% P = 0.022 0.0% % Re sp on de rs † 14.3% Treatment Effect Treatment effect greater than approved IBS brands with Phase 3 PROs (Xifaxan®, Viberzi®, Linzess®, Amitiza®, and Trulance®) CeD PRO* Responder† Analysis P2b Trial1CeD-GSRS: Primary Endpoint for Phase 2b1 *CeD 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. †Responder = Subject has 50% improvement vs. baseline CeD PRO abdominal score (6/12 weeks). 1. Leffler DA 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 0.5 mg 1 mg 2 mg CeD GSRS1 P values 0.022 0.900 0.590 Positive Phase 2b with Statistically Significant P Value at Therapeutic Dose 23


 
CeDLaraStudy: Enriched Phase 3 Trial Design in Celiac Disease (n = ~525) Screening/Eligibility Period 12-week Double-Blind Treatment Phase Primary Endpoint Analyzed at Week 12 Day -35 Week 5 Visit 1 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 Day 168 ± 3 Week 24 Visit 8 (End) Initiate Double-Blind Study Drug on Day 1 Randomization 1:1:1 Larazotide 0.50 mg TID (~n = 175) Larazotide 0.25 mg TID (~n = 175) Placebo (~n = 175) 3. Primary Endpoint: CeDPRO Abdominal Domain at 12 Weeks1 Mean change from baseline for celiac disease symptom severity based on CeD PRO symptom scores (continuous variable). 1. Key Inclusion Criteria Similar to Phase 2b • Adults with celiac disease • Gluten-free diet symptoms monitored • Include patients with symptoms despite a GFD 2. 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 1. CeD PRO Abdominal Domain = abdominal cramping, abdominal pain, bloating and gas; ClinicalTrials.gov Identifier: NCT03569007 CeDLara = The Study of Celiac Disease with Larazotide. 12-week Double-Blind Safety Phase 25


 
near-term development milestones 2021 2022 3Q21 Initiated IND-enabling pathway for NM-102 Initiated IND-enabling pathway for NM-003 Acquired and initiated IND-enabling pathway for NM-136 2H22 Initiate Phase 3 vurolenatide SBS trial Topline larazotide Phase 2a MIS-C readout Top-line larazotide Phase 3 readout in celiac disease NM-102, NM-136 and NM-104 progression toward pre-ID meeting 25 4Q21 Initiated larazotide Phase 2a MIS-C trial Initiated NM-003 pre- clinical PoC Initiated NM-102 collaboration with Gustave Roussy 1H22 Topline vurolenatide Phase 2 trial readout in 2Q SBS R & D Day post FDA End-of-Phase 2 meeting Interim analysis Phase 3 larazotide for celiac disease in 2Q


 
early stage development programs 26


 
23 • 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 tight junctions between gut epithelial cells into the bloodstream, leading to the hyperinflammatory immune response • Larazotide’s MOA as a tight junction regulator may prevent SARS-CoV-2 superantigens from entering the bloodstream multisystem inflammatory syndrome in children (MIS-C) 1. J Clin Invest. 2021;131(14):e149633. https://doi.org/10.1172/JCI149633. 28


 
23 • 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 decrease in inflammatory markers, and a resultant clinical improvement in the Larazotide-treated MIS-C patient1 • Publication accepted for remaining cohort of 4 patients (in press) • Ongoing Phase 2a trial* in MIS-C was initiated in collaboration with European Biomedical Institute of Salerno (EBRIS) in October 2021 • The primary aim of this study is to evaluate the efficacy and safety of larazotide versus placebo in pediatric patients with SARS-CoV-2 infection who experience early signs of MIS-C and are at high risk of progression • Topline larazotide Phase 2a MIS-C readout in 2H 2022 phase 2 clinical trial in MIS-C * 21-day trial with weight-based dosing. 1. J Clin Invest. 2021;131(14):e149633. https://doi.org/10.1172/JCI149633. 29 Screening 21-Day Double-Blind Treatment Phase Primary Endpoint Analyzed at 21 Days Weeks 1, 2, 3 Visits 1, 2, 3 Double-Blind Study Drug on Day 1 Larazotide 10µg/kg/dose (max 500µg) PO QID + standard of care for MIS-C (n=10) Placebo + standard of care for MIS-C (n = 10) 24-week Follow-up No study drug Week 12 Visit 4 Week 24 Visit 5 Day 1 Baseline Weeks 4 + 8 Telemedicine Visits Weeks 16 + 20 Telemedicine Visits


 
nm-003: long-acting glp-2 agonist XTEN R Molecule is an NCE through recombinantly derived process teduglutide ~3.8 kDa Gln HisGly Ser SerAspPheAspGly Glu Met Asn ThrIleLeuAspAsnAlaAla LewArg Phe Asp Ile AsnTrpLeu IleIle ThrLys Thr Asp nm-003 ~77 kDa + 27 1. Alters SE, McLaughlin B, Spink B, et al. PLoS One. 2012;7(11):e50630. 1


 
nm-102: tight-junction microbiome modulator1 non-ischemic ischemic larazotide nm-102 (0.1 uM) nm-102 (1.0 uM) nm-102 (10 uM) Electrophysiological responses and histomorphology of ischemia-injured porcine jejunal mucosa to treatment with single doses of nm-102 at various concentrations. Statistical significance is between either ischemic tissue treated with nm-102 vs untreated ischemic tissue (*) or ischemic tissue treated with larazotide vs untreated ischemic tissue (#) during the 240-minute recovery period. Values are means ± SEM; n ≥ 4. 1. Slifer ZM et al. PLoS One. 2021;16(4):e0250165. https://doi.org/10.1371/journal.pone.0250165 • nm-102 is a tight-junction modulator chemically distinct from larazotide • Data from ex vivo porcine tissue (shown) details tissue recovery • Collaboration with Gustave-Roussy Institute (Paris) confirmed activity of nm-102 in immune checkpoint inhibitor failure model of melanoma: prolonged survival and improved tumor decreasing efficacy • CMC optimization and IND-enabling program underway with anticipated first-in-human studies in 2022 28


 
nm-136: humanized anti-GIP monoclonal antibody1 control nm-136 treated mouse white portions represents fat tissue 1. Boylan MO et al. Am J Physiol. 2015;309:E1008-E1018. 29 • 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 pathway underway and intend to conduct a clinical proof-of-concept in 2023


 
John Temperato President, Chief Executive Officer & Director jtemperato@9meters.com 8480 Honeycutt Road, Suite 120 Raleigh, NC 27615 Telephone: 1-919-275-1933 info@9meters.com www.9meters.com Twitter LinkedIn Bethany Sensenig, MBA, CMA Chief Financial Officer bsensenig@9meters.com Al Medwar, MBA SVP, Investor Relations & Corporate Communications amedwar@9meters.com