NMTR 9 Meters Biopharma Inc.

0.64
-0.08  -11%
Previous Close 0.72
Open 0.7
52 Week Low 0.3701
52 Week High 1.29
Market Cap $61,610,484
Shares 96,251,342
Float 70,184,763
Enterprise Value $71,176,828
Volume 3,875,445
Av. Daily Volume 993,074
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Upcoming Catalysts

Drug Stage Catalyst Date
Larazotide
Celiac disease
Phase 3
Phase 3
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NM-002
Short bowel syndrome
Phase 1/2
Phase 1/2
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Latest News

  1. Conference Call Scheduled for July 9, 2020

    RALEIGH, NC / ACCESSWIRE / July 2, 2020 / 9 Meters Biopharma, Inc. (NASDAQ:NMTR), a clinical-stage rare and unmet needs-focused gastroenterology company, today announced that the Executive Management team will participate in the Hidden Gems in Healthcare Conference Call Series hosted by Gary Nachman and BMO Capital Markets on Thursday, July 9, 2020. Please see additional details below:

    Hidden Gems in Healthcare Conference Call Series

    Date: Thursday, July 9th, 2020
    Time: 11:00 am Eastern Time

    Title: 9 Meters: A New Champion in GI for Rare, Orphan and Unmet Needs

    Speakers: John Temperato, President & CEO
    Edward Sitar, CFO
    Patrick Griffin, MD, FACS, CMO
    Sireesh Appajosyula, PharmD, SVP Corporate Development &

    Conference Call Scheduled for July 9, 2020

    RALEIGH, NC / ACCESSWIRE / July 2, 2020 / 9 Meters Biopharma, Inc. (NASDAQ:NMTR), a clinical-stage rare and unmet needs-focused gastroenterology company, today announced that the Executive Management team will participate in the Hidden Gems in Healthcare Conference Call Series hosted by Gary Nachman and BMO Capital Markets on Thursday, July 9, 2020. Please see additional details below:

    Hidden Gems in Healthcare Conference Call Series

    Date: Thursday, July 9th, 2020
    Time: 11:00 am Eastern Time

    Title: 9 Meters: A New Champion in GI for Rare, Orphan and Unmet Needs

    Speakers: John Temperato, President & CEO
    Edward Sitar, CFO
    Patrick Griffin, MD, FACS, CMO
    Sireesh Appajosyula, PharmD, SVP Corporate Development & Operations

    Conference Toll Free Dial-In: 800-348-8995
    Details: Local Dial-In: 973-528-0026
    Entry Code: 540307

    Replay Toll Free Dial-In: 800-332-6854
    Details: Local Dial-In: 973-528-0005
    Entry Code: 540307

    An audio replay of the call will be accessible on the Events page of the Investors section on the Company's website at www.9Meters.com. The audio replay will be available after the conference ends and will be accessible until July 23, 2020.

    About 9 Meters Biopharma

    9 Meters Biopharma, Inc. (NASDAQ:NMTR, the Company", ))) is a rare and unmet needs focused gastroenterology company. The Company is advancing NM-002, a proprietary long-acting GLP-1 agonist into a Phase 2 trial for Short Bowel Syndrome (SBS), a rare, orphan disease, as well as larazotide, a Phase 3 tight junction regulator being evaluated for patient-reported symptom improvement in non-responsive celiac disease. 9 Meters is led by a strong management team with a history of bringing novel therapeutics to market, and the Company owns all global rights to their products, which are backed by more than 150 patents worldwide. For more information, please visit www.9meters.com.

    Forward-looking Statements

    This press release includes forward-looking statements based upon the Company's current expectations. Forward-looking statements involve risks and uncertainties, and include, but are not limited to, the potential effects of the ongoing coronavirus outbreak and related mitigation efforts on the Company's clinical, financial and operational activities; the Company's continued listing on Nasdaq; expectations regarding future financings; the future operations of the Company; the nature, strategy and focus of the Company; the development and commercial potential and potential benefits of any product candidates of the Company; anticipated preclinical and clinical drug development activities and related timelines, including the expected timing for data and other clinical and preclinical results; the Company having sufficient resources to advance its pipeline; and any other statements that are not historical fact. 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 that may result therefrom; (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 proposed merger and future financings and (vi) risks associated with the possible failure to realize certain anticipated benefits of the Company's recent merger and the Naia acquisition, 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, 2019, Form 10-Q for the quarter ended March 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.

    Corporate contact

    Edward J. Sitar, Chief Financial Officer
    9 Meters Biopharma, Inc.

    www.9meters.com

    Media contact

    Amy Jobe, Ph.D.
    LifeSci Communications, LLC

    315-879-8192

    Investor contact

    Corey Davis, Ph.D.
    LifeSci Advisors, LLC

    212-915-2577

    SOURCE: 9 Meters Biopharma, Inc.



    View source version on accesswire.com:
    https://www.accesswire.com/595929/9-Meters-Biopharma-Inc-to-Participate-in-BMO-Capital-Markets-Hidden-Gems-in-Healthcare-Conference-Call-Series

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  2. -New methodology enables a more capital-efficient study, with reduction in participants from 630 to 525 while maintaining statistical powering at 90%

    -Continuous variable approach more aptly reflects change in celiac disease patient symptoms over trial duration

    RALEIGH, NC / ACCESSWIRE / June 29, 2020 / 9 Meters Biopharma, Inc. (NASDAQ:NMTR), a clinical-stage rare and unmet needs-focused gastroenterology company, today announced that, after consultation with the FDA, the company will modify its definition of the primary endpoint in the ongoing Phase 3 trial evaluating larazotide for treating celiac disease. The validated instrument used for the primary assessment remains the Celiac Disease Patient-Reported Outcome (CeD PRO). However, the definition…

    -New methodology enables a more capital-efficient study, with reduction in participants from 630 to 525 while maintaining statistical powering at 90%

    -Continuous variable approach more aptly reflects change in celiac disease patient symptoms over trial duration

    RALEIGH, NC / ACCESSWIRE / June 29, 2020 / 9 Meters Biopharma, Inc. (NASDAQ:NMTR), a clinical-stage rare and unmet needs-focused gastroenterology company, today announced that, after consultation with the FDA, the company will modify its definition of the primary endpoint in the ongoing Phase 3 trial evaluating larazotide for treating celiac disease. The validated instrument used for the primary assessment remains the Celiac Disease Patient-Reported Outcome (CeD PRO). However, the definition of the primary endpoint will now utilize a continuous variable instead of a responder analysis. The design and execution of the ongoing trial have not been affected.

    The trial is a randomized, double-blind, placebo-controlled study to evaluate the safety and efficacy of larazotide for patients with celiac disease who continue to experience gastrointestinal symptoms while following a gluten-free diet. The primary efficacy outcome of the study comprises the mean change from baseline on the CeD PRO rating scale abdominal domain over 12 weeks for two active treatment doses (0.25 mg and 0.50 mg) compared to placebo.

    "We have adjusted our approach to the primary endpoint calculation after consultation with the FDA to utilize a continuous variable instead of a responder analysis. Consequently, we have reduced the size of the study population to 525 from the original 630, while maintaining the study's original 90% statistical powering," said Patrick H. Griffin, M.D., FACP, chief medical officer of 9 Meters.

    The trial is currently under way at over 100 clinical sites, with an interim analysis still anticipated during the first half of 2021 and topline data anticipated in the second half of 2021. For more information on the trial, please visit Clinicaltrials.gov: NCT03569007.

    About 9 Meters Biopharma

    9 Meters Biopharma, Inc. ("the Company") is a rare unmet needs-focused GI platform company. The Company is advancing NM-002, a proprietary long-acting GLP-1 agonist into Phase 2 trial for Short Bowel Syndrome (SBS), a rare, orphan disease, as well as larazotide, a Phase 3 tight junction regulator being evaluated for patient-reported symptom improvement in non-responsive celiac disease.

    For more information, please visit www.9meters.com.

    Forward-looking Statements

    This press release includes forward-looking statements based upon the Company's current expectations. Forward-looking statements involve risks and uncertainties, and include, but are not limited to, the potential effects of the ongoing coronavirus outbreak and related mitigation efforts on the Company's clinical, financial and operational activities; the Company's continued listing on Nasdaq; expectations regarding future financings; the future operations of the Company; the nature, strategy and focus of the Company; the development and commercial potential and potential benefits of any product candidates of the Company; anticipated preclinical and clinical drug development activities and related timelines, including the expected timing for data and other clinical and preclinical results; the Company having sufficient resources to advance its pipeline; and any other statements that are not historical fact. 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 that may result therefrom; (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 proposed merger and future financings and (vi) risks associated with the possible failure to realize certain anticipated benefits of the Company's recent merger and the Naia acquisition, 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, 2019, Form 10-Q for the quarter ended March 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.

    Corporate contacts

    Edward J. Sitar
    Chief Financial Officer
    9 Meters Biopharma, Inc.

    www.9meters.com

    Media contact

    Amy Jobe, Ph.D.
    LifeSci Communications, LLC

    315-879-8192

    Investor contact

    Corey Davis, Ph.D.
    LifeSci Advisors, LLC

    212-915-2577

    SOURCE: 9 Meters Biopharma, Inc.



    View source version on accesswire.com:
    https://www.accesswire.com/595392/9-Meters-Biopharma-Inc-Amends-Definition-of-Primary-Endpoint-for-Phase-3-Trial-in-Celiac-Disease-After-Consultation-with-FDA

    View Full Article Hide Full Article
    • Study in adult short bowel syndrome (SBS) patients initiated in June 2020
    • NM-002 is a long-acting GLP-1 agonist designed to address the gastric effects in SBS patients by slowing digestive transit time
    • First patient expected to be dosed in July 2020

    RALEIGH, NC / ACCESSWIRE / June 24, 2020 / 9 Meters Biopharma, Inc. (NASDAQ:NMTR), a clinical-stage rare and unmet needs-focused gastroenterology company, today announced it has initiated its Phase 1b/2a clinical trial of NM-002 for the treatment of short bowel syndrome (SBS), a life-threatening orphan disease caused by a significant shortening of the gastrointestinal tract, leading to impaired nutrient absorption. NM-002 is a long-acting injectable glucagon-like peptide-1 (GLP-1) agonist designed…

    • Study in adult short bowel syndrome (SBS) patients initiated in June 2020
    • NM-002 is a long-acting GLP-1 agonist designed to address the gastric effects in SBS patients by slowing digestive transit time
    • First patient expected to be dosed in July 2020

    RALEIGH, NC / ACCESSWIRE / June 24, 2020 / 9 Meters Biopharma, Inc. (NASDAQ:NMTR), a clinical-stage rare and unmet needs-focused gastroenterology company, today announced it has initiated its Phase 1b/2a clinical trial of NM-002 for the treatment of short bowel syndrome (SBS), a life-threatening orphan disease caused by a significant shortening of the gastrointestinal tract, leading to impaired nutrient absorption. NM-002 is a long-acting injectable glucagon-like peptide-1 (GLP-1) agonist designed specifically to exploit gut motility effects in SBS patients by slowing digestive transit time.

    The Phase 1b/2a clinical trial of NM-002 is an open-label, single-center study evaluating the safety and tolerability of three escalating doses of NM-002 in adult patients with SBS. The three different dosing cohorts will each receive two doses of NM-002 two weeks apart, with daily urine output as a primary endpoint, an inversely related proxy for usage of parenteral support. Parental support is a current treatment option used to intravenously provide SBS patients with hydration, essential nutrients and electrolytes. NM-002 has demonstrated safety with an extended half-life of up to 30 days in a 70-patient clinical study and has received Orphan Designation by the U.S. Food and Drug Administration.

    "Advancing NM-002 into our Phase 1b/2a trial is a major milestone for 9 Meters as we strive to create a more effective treatment option for patients with SBS," said John Temperato, president and chief executive officer of 9 Meters. "Not only is SBS a life-threatening disease when untreated, but the current treatment standard of parenteral support is insufficient, as it results in an extremely low quality of life for patients. We look forward to developing NM-002 to reduce reliance on intravenous supplementation, and therefore give patients the freedom to live a less restricted lifestyle and reduce their financial burden."

    "In developing NM-002, we've used Amunix's proprietary XTEN® technology to extend the half-life of the GLP-1 peptide, which allows the drug to be injected only once or twice per month. This considerably increases convenience for patients and caregivers compared to other GLP-2 drug products on the market for SBS which must be dosed daily," said Patrick H. Griffin, M.D., FACP, chief medical officer of 9 Meters.

    The trial will take place at Cedars-Sinai in Los Angeles. The first patient is expected to be dosed in this Phase 1b/2a trial in July 2020, with topline results expected in the first half of 2021. For more information on the trial, please visit ClinicalTrials.gov: NCT04379856.

    The patent rights covering the use of the GLP-1 agonist technology to treat short bowel syndrome are owned by Cedars-Sinai Medical Center and are exclusively licensed by Cedars-Sinai to Naia Rare Diseases, a wholly-owned subsidiary of the 9 Meters Biopharma, Inc.

    About Short Bowel Syndrome

    According to the National Institute of Diabetes, and Digestive and Kidney Diseases (NIDDK), SBS is a rare syndrome of problems related to poor absorption of nutrients as a result of at least half of the small intestine being removed and sometimes all or part of the large intestine; significant damage to the small intestine; or poor motility, or movement inside of the intestines. The incidence of SBS is poorly known but estimated at about 5 to 10 patients per year per million population. In adults, the incidence of SBS requiring at-home parenteral nutrition is estimated at two adult patients per year per million population. Pharmacologic therapies for SBS include trophic factors, such as short-acting daily injectable GLP-2 analogues, which may not be appropriate for all patient types.

    About 9 Meters Biopharma
    9 Meters Biopharma, Inc. is a rare and unmet needs-focused GI company. The Company is advancing NM-002, a proprietary long-acting GLP-1 agonist into a Phase 1b/2a trial for Short Bowel Syndrome (SBS), an orphan designated disease, as well as larazotide, a Phase 3 tight junction regulator being evaluated for celiac disease.

    For more information, please visit www.9meters.com.

    Forward-Looking Statements

    This press release includes forward-looking statements based upon the Company's current expectations. Forward-looking statements involve risks and uncertainties, and include, but are not limited to, the potential effects of the ongoing coronavirus outbreak and related mitigation efforts on the Company's clinical, financial and operational activities; the Company's continued listing on Nasdaq; expectations regarding future financings; the future operations of the Company; the nature, strategy and focus of the Company; the development and commercial potential and potential benefits of any product candidates of the Company; anticipated preclinical and clinical drug development activities and related timelines, including the expected timing for data and other clinical and preclinical results; the Company having sufficient resources to advance its pipeline; and any other statements that are not historical fact. 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 that may result therefrom; (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 proposed merger and future financings and (vi) risks associated with the possible failure to realize certain anticipated benefits of the proposed Merger and the Naia acquisition, 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 as a result 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 Innovate Biopharmaceuticals, Inc. Annual Report on Form 10-K for the year ended December 31, 2019 and in other filings that Innovate 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 contacts

    Edward J. Sitar
    Chief Financial Officer
    9 Meters Biopharma, Inc.

    www.9meters.com

    Media contact

    Amy Jobe, Ph.D.
    LifeSci Communications, LLC

    315-879-8192

    Investor contact

    Corey Davis, Ph.D.
    LifeSci Advisors, LLC

    212-915-2577

    SOURCE: 9 Meters Biopharma, Inc.



    View source version on accesswire.com:
    https://www.accesswire.com/595127/9-Meters-Biopharma-Inc-Initiates-Phase-1b2a-Clinical-Trial-in-Short-Bowel-Syndrome

    View Full Article Hide Full Article
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