NMTR stock popped 15% in after-hours trading on June 30, 2020, after a SunTrust analyst gave the stock a Buy rating.
SunTrust analyst Srikripa Devarakonda initiated coverage of 9 Meters Biopharma with a Buy rating and $5 price target. The analyst is positive on the company’s programs in Celiac Disease, or CED, and Short Bowel Syndrome, or SBS, noting that its “two shots on goal” with differentiated products represent a combined global peak sales unadjusted opportunity of about $1B. Devarakonda sees a “catalyst-rich” 12-18 month period for 9 Meters with its first PoC data in SBS and pivotal data in CeD, while also pointing to the company’s “experienced management with over 50 years combined experience”.
On June 29, 2020, 9 Meters Biopharma 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 company said in a release, “The validated instrument used for the primary assessment remains the Celiac Disease Patient-Reported Outcome, or 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. The trial is currently underway 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.”
On June 24, 2020, 9 Meters Biopharm 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.