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9 Meters Biopharma has secured a $20 million initial draw from a $70 million senior secured convertible notes facility to advance the development of vurolenatide for short bowel syndrome. The facility allows for an additional $50 million access over 18 months. Following this draw, the company's total cash and investments are projected to reach $57 million, ensuring a cash runway extending into Q4 2023. The move aims to support NDA submission for vurolenatide, as well as ongoing clinical trials amidst ongoing financial market challenges.
9 Meters Biopharma (NASDAQ:NMTR) released positive preliminary results from its Phase 2 VIBRANT study of vurolenatide, aimed at treating short bowel syndrome (SBS). The study showed a >25% improvement in 24-hour mean total stool output reduction over six weeks, with 7 of 11 patients meeting the primary efficacy endpoint. The drug was well tolerated, with no adverse events leading to early withdrawal. An end-of-Phase 2 meeting with the FDA is set for mid-third quarter, with plans for a Phase 3 study beginning in Q4 2022.
9 Meters Biopharma (NASDAQ:NMTR) announced the completion of an interim analysis for its Phase 3 study of larazotide for celiac disease, which concluded that an insufficient number of patients could yield significant clinical outcomes. The interim review involved the first half of the target enrollment and highlighted the complexities of measuring treatment efficacy. Despite the setback, the company will analyze subgroup responses and refocus resources on advancing vurolenatide for short bowel syndrome, with results expected by month-end.
9 Meters Biopharma (NASDAQ: NMTR) announced its participation in the 2022 BIO International Convention from June 13-16 in San Diego, CA. This event aligns with the company's strategy to seek partners for developing its advanced treatments: vurolenatide for short bowel syndrome and larazotide for celiac disease. The BIO Convention is the largest biotechnology gathering globally, hosting over 15,000 leaders in the biopharmaceutical sector. 9 Meters aims to leverage this platform for networking and partnering opportunities.
9 Meters Biopharma (NASDAQ:NMTR) will exhibit at Digestive Disease Week (DDW) from May 21-24, 2022, in San Diego, CA. The company will showcase its lead product candidates: vurolenatide for short bowel syndrome and larazotide for celiac disease, among others. Located at booth #1625, 9 Meters aims to engage with healthcare professionals and promote its pipeline. Additionally, it will match donations up to $7,500 to Mend Hunger, a charity focused on gluten-free hunger relief. This marks the company's first exhibit at DDW.
9 Meters Biopharma (NASDAQ:NMTR) presented preclinical data at the ATS International Conference, showcasing larazotide's potential in reducing lung fibrosis in idiopathic pulmonary fibrosis (IPF). The data indicated that oral administration of larazotide resulted in a greater reduction of pulmonary fibrosis compared to intratracheal administration. This research suggests that the gastrointestinal effects of larazotide may have clinical benefits for IPF treatment via the gut-lung axis. The company is concurrently advancing larazotide in a Phase 3 trial for celiac disease.
9 Meters Biopharma (Nasdaq: NMTR) announced significant progress in its clinical trials during its recent earnings update for Q1 2022. The company is set to report Phase 2 data for vurolenatide in June and anticipates an interim analysis of larazotide's Phase 3 trial for celiac disease in the same month. With a cash balance of $37.2 million, 9 Meters expects to fund its clinical programs through Q2 2023. The net loss for the quarter was approximately $11.4 million, reflecting increased investment in clinical development.
9 Meters Biopharma, Inc. (NASDAQ:NMTR) announced that President & CEO John Temperato will present at two upcoming events: the LifeSci Partners Immunology & Inflammation Symposium on May 10, 2022, and the H.C. Wainwright Global Investment Conference from May 23-26, 2022. The presentations will focus on the company’s pipeline, including vurolenatide for short bowel syndrome and larazotide for celiac disease. Data from both studies is anticipated in the coming months, highlighting the company's commitment to rare digestive diseases.
9 Meters Biopharma (NASDAQ:NMTR) collaborates with Celiac.com to enhance enrollment in its Phase 3 CeDLara study for larazotide, aimed at treating celiac disease. The randomized trial targets adults with persistent symptoms despite a gluten-free diet. An interim analysis is expected by early June. This partnership aims to bridge the treatment gap for individuals suffering from celiac disease, potentially leading to the first FDA-approved therapy for this condition.
9 Meters Biopharma (NASDAQ:NMTR) announced the allowance of U.S. Patent Application No. 16/781,304 for their drug NM-136, aimed at treating hyperphagia, obesity, and reducing fatty tissue in organs. This monoclonal antibody targets GIP receptors, with preclinical studies showing significant reductions in weight and abdominal fat. The patent bolsters the company's pipeline, which includes advanced products for short bowel syndrome and celiac disease. The company anticipates moving toward an IND filing for NM-136, recognizing its potential in treating metabolic disorders.
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