1. -William Blair Biotech Focus Conference -
    August 4th- 6th

    -BTIG Virtual Biotechnology Conference -
    August 10th & 11th

    RALEIGH, NC / ACCESSWIRE / August 4, 2020 / 9 Meters Biopharma, Inc. (NASDAQ:NMTR), today announced that management will participate in the following conferences in the month of August and invites investors to participate by webcast. Please see additional details below:

    William Blair Virtual Biotech Focus Conference

    Date: Tuesday - Thursday, August 4th - 6th 2020
    Agenda: Agenda Link

    BTIG Virtual Biotechnology Conference

    Title: 9 Meters Biopharma (NMTR) Fireside Chat
    Date: Monday, August 10th 2020
    Time: 2:30 - 2:55pm Eastern Time
    Presenter: John Temperato, President & CEO

    An replay of the webcast will be accessible on the Events page of…

    -William Blair Biotech Focus Conference -
    August 4th- 6th

    -BTIG Virtual Biotechnology Conference -
    August 10th & 11th

    RALEIGH, NC / ACCESSWIRE / August 4, 2020 / 9 Meters Biopharma, Inc. (NASDAQ:NMTR), today announced that management will participate in the following conferences in the month of August and invites investors to participate by webcast. Please see additional details below:

    William Blair Virtual Biotech Focus Conference

    Date: Tuesday - Thursday, August 4th - 6th 2020
    Agenda: Agenda Link

    BTIG Virtual Biotechnology Conference

    Title: 9 Meters Biopharma (NMTR) Fireside Chat
    Date: Monday, August 10th 2020
    Time: 2:30 - 2:55pm Eastern Time
    Presenter: John Temperato, President & CEO

    An replay of the webcast will be accessible on the Events page of the Investors section on the Company's website at www.9Meters.com.

    About 9 Meters Biopharma
    9 Meters Biopharma, Inc. ("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.

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

    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.



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  2. U.S. Pat. No. 10,723,763 issued on July 28, 2020, shows Larazotide reduces endothelial barrier permeability in a dose dependent fashion in both ALI and ARDS

    RALEIGH, NC / ACCESSWIRE / July 28, 2020 / 9 Meters Biopharma, Inc. (NASDAQ:NMTR), a clinical-stage rare and unmet needs-focused gastroenterology company, announced today the U.S. Patent and Trademark Office ("USPTO") issued U.S. Pat. No. 10,723,763, titled, Use of Tight Junction Antagonists in the Treatment of Acute Lung Injury and Acute Respiratory Distress, relating to its proprietary investigational agent, larazotide.

    "The issuance of this patent by the USPTO validates the unique mechanistic profile of our novel first-in-class tight junction modulator currently in Phase 3 development for…

    U.S. Pat. No. 10,723,763 issued on July 28, 2020, shows Larazotide reduces endothelial barrier permeability in a dose dependent fashion in both ALI and ARDS

    RALEIGH, NC / ACCESSWIRE / July 28, 2020 / 9 Meters Biopharma, Inc. (NASDAQ:NMTR), a clinical-stage rare and unmet needs-focused gastroenterology company, announced today the U.S. Patent and Trademark Office ("USPTO") issued U.S. Pat. No. 10,723,763, titled, Use of Tight Junction Antagonists in the Treatment of Acute Lung Injury and Acute Respiratory Distress, relating to its proprietary investigational agent, larazotide.

    "The issuance of this patent by the USPTO validates the unique mechanistic profile of our novel first-in-class tight junction modulator currently in Phase 3 development for celiac disease," said John Temperato, president and chief executive officer of 9 Meters. "This patent along with the vast pre-clinical and clinical data that has characterized larazotide, highlight the importance of normalizing leaky tight junctions in disparate disease states. Given the potential clinical impact that may result from normalizing tight junctions in disorders beyond larazotide's main target of celiac disease, we are allowing the exploration of the compound's broader potential utility in certain cases."

    The granted 9 Meters' patent shows, in a dose dependent fashion, larazotide renormalizes abnormally increased permeability of pulmonary tissue containing cellular tight junctions, and treats the direct cause of ALI and ARDS which can lead to fluid buildup within affected areas of the lungs.1 In pre-clinical models, larazotide has been shown to improve ALI as measured by protein, cellular and inflammatory markers2, as well as suggest a protective effect in virally-challenged mice during infection, mitigating ALI by blunting pulmonary edema.3 Previous experiments have shown larazotide inhibits tight-junction rearrangement and prevents epithelial permeability triggered by gliadin, the antigen responsible for immunogenicity and symptoms in people with celiac disease.4

    Furthermore, larazotide has been identified as a potential candidate in studies to target the main protease or Mpro also known as 3C-like protease of SARS-CoV-2, the virus responsible for COVID-19.5,6 Coupling this emerging data along with the molecule's known effects on epithelial and endothelial tight junctions, 9 Meters is evaluating potential next steps for future research to address the possible extended implications of larazotide for ALI/ARDS associated with COVID-19 for internal or out-licensing development.

    About 9 Meters Biopharma
    9 Meters Biopharma, Inc. ("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.

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

    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

    1. Diamond M, Peniston Feliciano HL, Sanghavi D, et al. Acute Respiratory Distress Syndrome (ARDS) [Updated 2020 Jul 2]. In: StatPearls Publishing; 2020 Jan. Available from: https://www.ncbi.nlm.nih.gov/books/NBK436002/
    2. Rittirsch D, Flierl MA, Nadeau BA, et al. Zonulin as prehaptoglobin2 regulates lung permeability and activates the complement system. Am J Physiol Lung Cell Mol Physiol. 2013;304(12):L863-L872. doi: 10.1152/ajplung.00196.2012
    3. Shirey KA, Lai W, Patel MC, et al. Novel strategies for targeting innate immune responses to influenza. Mucosal Immunol. 2016;9(5):1173-1182. doi: 10.1038/mi.2015.141
    4. Shobha Gopalakrishnan, Malarvizhi Durai, Kelly Kitchens, et al. Larazotide acetate regulates epithelial tight junctions in vitro and in vivo. Peptides. Volume 35, Issue 1, 2012, Pages 86-94. doi: 10.1016/j.peptides.2012.02.015
    5. Luca Pinzi, Annachiara Tinivella, Fabiana Caporuscio et al. Drug repurposing and polypharmacology to fight SARS-CoV-2 through the inhibition of the main protease, 06 May 2020. Preprint. doi: 10.21203/rs.3.rs-27222/v1
    6. Liu, Hao; Jiang, Tao; Liu, Wenlang; Zheng, Zheng (2020): Computational Evaluation of the COVID-19 3c-like Protease Inhibition Mechanism, and Drug Repurposing Screening. ChemRxiv. Preprint. doi: 10.26434/chemrxiv.12090426.v1

    SOURCE: 9 Meters Biopharma



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  3. NM-002 is a long-acting GLP-1 agonist designed to address the gastric effects in SBS patients by slowing digestive transit time

    RALEIGH, NC / ACCESSWIRE / July 21, 2020 / 9 Meters Biopharma, Inc. (NASDAQ:NMTR), a clinical-stage rare and unmet needs-focused gastroenterology company, announced today that the first patients have been dosed in a Phase 1b/2a clinical trial to assess NM-002 in adults with short bowel syndrome (SBS).

    SBS is a life-threatening orphan disease caused by a significant shortening of the gastrointestinal tract, leading to impaired nutrient absorption. Many SBS patients rely at least partly on parenteral support, an intravenous method of providing hydration, essential nutrients and electrolytes. NM-002 is a long-acting injectable…

    NM-002 is a long-acting GLP-1 agonist designed to address the gastric effects in SBS patients by slowing digestive transit time

    RALEIGH, NC / ACCESSWIRE / July 21, 2020 / 9 Meters Biopharma, Inc. (NASDAQ:NMTR), a clinical-stage rare and unmet needs-focused gastroenterology company, announced today that the first patients have been dosed in a Phase 1b/2a clinical trial to assess NM-002 in adults with short bowel syndrome (SBS).

    SBS is a life-threatening orphan disease caused by a significant shortening of the gastrointestinal tract, leading to impaired nutrient absorption. Many SBS patients rely at least partly on parenteral support, an intravenous method of providing hydration, essential nutrients and electrolytes. NM-002 is a long-acting injectable glucagon-like peptide-1 (GLP-1) receptor agonist designed specifically to treat gastric motility in SBS patients by slowing digestive transit time, which may reduce reliance on parenteral support.

    The Phase 1b/2a clinical trial is an open-label, single-center study evaluating the safety and tolerability of three escalating doses of NM-002 in adult patients with SBS. Patients in each of three cohorts will receive two doses of NM-002 two weeks apart. Change in daily urine output volume is designated as the primary endpoint, as an inversely related proxy for usage of parenteral support.

    NM-002,which utilizes Amunix's proprietary XTEN® technology to extend the circulating half-life of the GLP-1 peptide (exenatide) has demonstrated acceptable safety and a half-life of up to 30 days in a 70-patient clinical study and has been granted Orphan Designation by the U.S. Food and Drug Administration.

    "9 Meters seeks to offer a therapeutic option for SBS patients that mitigates reliance on parenteral support, and minimizes the frequency of dosing for patients," said John Temperato, president and chief executive officer of 9 Meters. "When a shortened GI tract is incapable of absorbing sufficient nutrients and fluids, parenteral support is a life-saving measure. However, intravenous supplementation is extremely burdensome and can increase the risk of injection-site infection or kidney or liver complications. We hope that NM-002 can improve these patients' quality of life."

    "NM-002 has been designed specifically to slow gut motility to allow more time for nutrient and fluid absorption. We believe NM-002 offers several advantages over the current GLP-2 product approved for SBS, with a potentially faster onset of action and a longer circulating half-life that should allow once- or twice-monthly dosing rather than the current standard of daily injections," said Patrick H. Griffin, M.D., FACP, chief medical officer of 9 Meters.

    The trial is taking place at Cedars-Sinai in Los Angeles, with topline results expected in the first half of 2021. For more information, 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 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. ("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.

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

    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.



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  4. RALEIGH, NC / ACCESSWIRE / July 6, 2020 / 9 Meters Biopharma, Inc. (NASDAQ:NMTR), a clinical-stage rare and unmet needs-focused gastroenterology company, announced today the Company has appointed Michael T. Constantino to its board of directors.

    Mr. Constantino is a North Carolina certified public accountant who served as an Ernst & Young LLP assurance partner for more than 30 years, serving public and private entrepreneurial companies across several industries, including biotechnology, pharmaceuticals, contract research and technology. Of note, he has acted as a coordinating partner with the gastrointestinal pharmaceutical company, Salix Pharmaceuticals (acquired by Valeant Pharmaceuticals), and contract pharmaceutical manufacturer, Patheon…

    RALEIGH, NC / ACCESSWIRE / July 6, 2020 / 9 Meters Biopharma, Inc. (NASDAQ:NMTR), a clinical-stage rare and unmet needs-focused gastroenterology company, announced today the Company has appointed Michael T. Constantino to its board of directors.

    Mr. Constantino is a North Carolina certified public accountant who served as an Ernst & Young LLP assurance partner for more than 30 years, serving public and private entrepreneurial companies across several industries, including biotechnology, pharmaceuticals, contract research and technology. Of note, he has acted as a coordinating partner with the gastrointestinal pharmaceutical company, Salix Pharmaceuticals (acquired by Valeant Pharmaceuticals), and contract pharmaceutical manufacturer, Patheon (acquired by Thermo Fisher Scientific). Mr. Constantino has worked closely with companies across various development stages, from early start-up to mature Fortune 100 corporations, and assisted management teams and boards of directors with SEC compliance matters, global operations and strategic planning.

    "Having worked closely with Mike in the context of Salix Pharmaceuticals, where I served as a board member, I know that his counsel and business acumen will be instrumental in assisting 9 Meters growth through clinical development to commercialization ," said Dr. Mark Sirgo, chairman of the board of directors of 9 Meters. We are fortunate to have Mike join the 9 Meters board at such an exciting time."

    "I admire 9 Meters' work to consolidate promising assets in a number of GI indications, and I am pleased to help direct their growth through critical early development stages," said Mr. Constantino. "With one lead asset in Phase 3 for celiac disease and the other in early-stage clinical trials for a rare orphan GI indication, it will be important to balance growth and development around both-an effort for which I look forward to offering guidance."

    Currently, Mr. Constantino is the Vice-Chair of the Board for the NC State Foundation. He has served as the Treasurer for the North Carolina Biotechnology Center, Chairman of the NC State Poole College of Management Board of Advisors, the Board of Directors and Treasurer for Rise Against Hunger (formerly, Stop Hunger Now), Board of Directors and Treasurer for the Council for Entrepreneurial Development, and Chairman and Treasurer for Southeast Life Sciences. He holds a B.A. in both Accounting and Business Management from NC State University.

    About 9 Meters Biopharma

    9 Meters Biopharma, Inc. ("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 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



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  5. 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.



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  6. -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

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    • 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

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