Item 8.01. Other Events.

9 Meters Biopharma, Inc. announced receipt of additional clarifying comments from the U.S. Food and Drug Administration (the "FDA") on the protocol for our Phase 3 double-blind, placebo-controlled study of vurolenatide for adult patients with short bowel syndrome. The comments from the FDA provide additional clarification and direction on specific elements of the study protocol and design. Based on the comments received from the FDA, the Company will align with the recommendations provided including the use of a continuous variable endpoint and a 24-week study duration for both subgroups of patients in the trial. We plan to enroll approximately 120 patients in the Phase 3 trial of vurolenatide and we still plan to conduct an interim analysis when 50% of patients reach 24 weeks.

On March 13, 2023, the Company updated its corporate presentation which can be found on the Company's website at www.9meters.com under the section titled Investors. A copy of the Company's presentation is filed as Exhibit 99.1 to this Current Report on Form 8-K and is incorporated by reference herein.

Forward-Looking Statements

This Current Report on Form 8-K 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: our ability to raise additional money to fund our operations for at least the next 12 months as a going concern and the need to raise additional capital to advance our product candidates and preclinical programs, including in light of current stock market conditions; 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, including in light of our recent and ongoing FDA communications; 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; intellectual property risks; the impact of COVID-19 on our operations, enrollment in and timing of clinical trials; reliance on collaborators; reliance on research and development partners; and risks related to cybersecurity and data privacy. 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.




Item 9.01.     Financial Statements and Exhibits.



(d) Exhibits

Exhibit No.           Description
Exhibit 99.1            9 Meters Biopharma, Inc. Corporate Presentation.
Exhibit 104           Cover Page Interactive Data File (embedded within the Inline XBRL document).

--------------------------------------------------------------------------------

© Edgar Online, source Glimpses