9 Meters Biopharma, Inc. (NASDAQ:NMTR), a clinical-stage company pioneering novel treatments for people with rare or debilitating digestive diseases, today announced the design of its Phase 3 clinical trial of vurolenatide for adults with short bowel syndrome (SBS). The study design follows the Company’s successful End-of-Phase 2 meeting and incorporates input received from the U.S. Food and Drug Administration (FDA).
Patrick H. Griffin, M.D., FACP, Chief Medical Officer at 9 Meters commented, “We are pleased to have our Phase 3 study design in place for vurolenatide for short bowel syndrome and look forward to study initiation. The study provides the opportunity to confirm previous clinical observations that vurolenatide treatment can reduce both parenteral support volume and total stool output volume, indicating improved absorption of fluid and nutrients, which is critical for these patients. These clinical effects, combined with the product’s safety and tolerability profile, if confirmed in Phase 3, are expected to contribute to improved overall quality of life for SBS patients.”
The Phase 3 study, called VIBRANT 2 (VurolenatIde for short Bowel syndrome Regardless of pArenteral support requiremeNT), is a randomized, double-blind, placebo-controlled, multicenter study evaluating the efficacy, safety, and tolerability of vurolenatide 50 mg administered subcutaneously every two weeks for 12 weeks in adults with SBS. This international clinical study is designed to enroll approximately 105 patients with SBS and will be conducted in up to 50 clinical investigative sites in North America and Europe. The study population will include both SBS patients who meet the current parenteral support (PS) dependence definition (PS required 3 or more times per week) and SBS patients who do not meet this PS requirement threshold (PS required fewer than 3 times per week).
Patients with SBS suffer from severe malabsorption due to the lack of sufficient intestinal surface which results directly in severe and often debilitating fluid and nutritional losses in the form of chronic, recurrent diarrhea. This study will not only assess the degree to which vurolenatide can reduce weekly PS volume requirements, but it will also, for the first time in a large ambulatory study, assess the impact of vurolenatide on malabsorptive diarrhea as measured directly by total stool output (TSO) volume.
To maximize the potential for vurolenatide to provide clinical benefit to the entire SBS population regardless of PS requirement, VIBRANT 2 incorporates two primary efficacy endpoints: 1) change from baseline in weekly PS volume which was the established primary efficacy outcome measure to support the approval of the GLP-2 agonist Gattex®(teduglutide) for treatment of SBS patients with a PS dependence; and 2) change from baseline in mean 24-hour TSO volume, which assesses TSO volume over the entire treatment period and incorporates specific FDA recommendations around the inclusion of nutrition and hydration parameters to help establish the clinical relevance of this novel endpoint.
9 Meters Biopharma Returns Vs. S&P
| 1 Year | 5 YEARS | 5 YEAR ANNUALIZED | SINCE IPO | |
|---|---|---|---|---|
| NMTR | -85.93% | -98% | ||
| S&P | -14.16% | +43.53% | +7.49% | +42% |
Assets
QUARTERLYANNUAL
| Q3 2022 | YOY CHANGE | |
|---|---|---|
| Net Cash | $15.86M | -70.4% |
| Accounts Receivable | – | – |
| Inventory | 0 | – |
Liabilities
QUARTERLYANNUAL
| Q3 2022 | YOY CHANGE | |
|---|---|---|
| Long Term Debt | $15.81M | +12,305.1% |
| Short Term Debt | $2.71M | +4,987.8% |
Ratios
QUARTERLYANNUAL
| Q3 2022 | YOY CHANGE | |
|---|---|---|
| Return On Assets | -83.8% | -8.1% |
| Return On Invested Capital | 151.7% | +27.1% |
Cash Flow
QUARTERLYANNUAL
| Q3 2022 | YOY CHANGE | |
|---|---|---|
| Free Cash Flow | -$11.06M | +35.2% |
| Operating Free Cash Flow | -$11.06M | +35.3% |
Valuation
QUARTERLYANNUAL
| Q4 2021 | Q1 2022 | Q2 2022 | Q3 2022 | YOY CHANGE | |
|---|---|---|---|---|---|
| Price to Earnings | – | – | – | – | – |
| Price to Book | 6.07 | 5 | 3.06 | 4.14 | -38.6% |
| Price to Sales | – | – | – | – | – |
| Price to Tangible Book Value | 101.52 | 74.40 | 43.53 | 50.45 | -54.5% |
| Price to Free Cash Flow TTM | – | – | – | – | – |
| Enterprise Value to EBITDA | -21.43 | -10.36 | -3.42 | -6.70 | -79.6% |
| Free Cash Flow Yield | – | – | – | – | – |
| Return on Equity | -99.7% | -131.4% | -112.2% | -132.0% | +8.4% |
| Total Debt | $0.17M | $0.15M | $0.14M | $18.52M | +10,150.8% |
