9 Meters Biopharma Announces Continued Immuno-Oncology Collaboration with Gustave Roussy

• Collaboration focuses on the relationship between intestinal microbiome composition and systemic responses to cancer treatments and builds upon additional positive preclinical data with investigational agent NM-102
• IND-enabling pathway for NM-102 underway with indication selection anticipated in 2023

RALEIGH, NC / ACCESSWIRE / November 14, 2022 / 9 Meters Biopharma, Inc. (NASDAQ:NMTR), a clinical-stage company pioneering novel treatments for people with rare or debilitating digestive diseases, today announced a continuing collaboration agreement with Gustave Roussy, a world-renowned cancer center in France, using 9 Meters' small molecule tight junction microbiome modulator NM-102. NM-102 is presumed to prevent gut microbial metabolites and antigens from trafficking into the systemic circulation.

This collaboration focuses on the relationship between intestinal microbiome composition and systemic responses to cancer treatments such as chemotherapy and immune checkpoint inhibitors (ICIs). Specifically, the work tested the hypothesis that the therapeutic effect of ICIs, such as antibodies to CTLA-4 and PD-1, might be enhanced by preventing bacterial antigens, toxins, and certain metabolites in the gut from interacting with the host immune system utilizing NM-102.

These studies showed that NM-102 was effective both when alone and when combined with ICIs in a transgenic mouse model of spontaneous aggressive skin melanoma. Furthermore, the combination of NM-102 with ICIs improved survival compared to ICIs alone. More recent data continues to show NM-102 in combination with ICIs improves overall survival in select mouse tumor models.

"We are encouraged by the work being conducted at Gustave Roussy and are excited to continue our collaboration with Professor Zitvogel and her team. Their expertise has served as the foundation for understanding important fundamental aspects of the gut microbiome and its' complex interaction with the immune system in cancer," said John Temperato, President and CEO of 9 Meters Biopharma.

Laurence Zitvogel, MD, PhD, Scientific Director of the Gustave Roussy Immuno-Oncology Program, commented, "We continue to study the delicate interactions between the intestinal epithelial cells, the microbiome, and the immune system in the gut and their consequences on tumor immunosurveillance. I am excited to continue our work with 9 Meters to look at strategies to advance therapies in cancer patients."

Gustave Roussy is launching the Clinicobiome Programme, a clinical and translational research program aimed at developing microbiota-centered interventions for cancer. The collaboration with 9 Meters and its small molecule tight junction modulators will even further strengthen this long-lasting endeavor.

Under the terms of the continuing collaboration, Gustave Roussy is investigating how tumors in preclinical models may affect intestinal integrity and in turn compromise the fitness of the host's immune system and its capacity to respond to ICIs. Deciphering the mechanism of NM-102 and its effects on intervening on the epithelial layer of the GI tract, as well as its potential translation to ICI efficacy in preclinical cancer in vivo models, is currently ongoing. The Company intends to move forward with an IND-enabling pathway with indication selection in 2023.

About 9 Meters Biopharma
9 Meters Biopharma, Inc. is a clinical-stage company pioneering novel treatments for people with rare digestive diseases, GI conditions with unmet needs, and debilitating disorders in which the biology of the gut is a contributing factor. 9 Meters is developing vurolenatide, a proprietary long-acting GLP-1 agonist, for SBS and several near clinical-stage assets including NM-102 and NM-136.

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Forward-Looking Statements
This press release includes forward-looking statements based upon 9 Meters' 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: risks related to our ability to successfully implement our strategic plans, including reliance on our lead product candidate; 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 inability of 9 Meters to obtain sufficient additional capital to continue to advance these product candidates and its preclinical programs, including in light of current stock market conditions; 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; uncertainties regarding the effect of the reverse stock split and our continued listing on Nasdaq; intellectual property risks; the impact of COVID-19 on our operations, enrollment in and timing of clinical trials; risks related to leveraging the Company by borrowing money under the debt facility and compliance with its terms; reliance on collaborators; reliance on research and development partners; risks related to cybersecurity and data privacy; 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 9 Meters' Annual Report on Form 10-K for the year ended December 31, 2021, as amended or supplemented by our Quarterly Reports on Form 10-Q and in other filings that 9 Meters has made and future filings 9 Meters 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. 9 Meters 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

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LifeSci Communications, LLC
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203-942-4626

SOURCE: 9 Meters Biopharma