- Announcement of Positive Preliminary Results from the VIBRANT Phase 2 Study of Vulolenatide in Short Bowel Syndrome
- Vulolenatide end-of-phase meeting with FDA on track for Q3
- Cash balance as of June 30, 2022 of $29.5 million; Additional $20 million from debt financing previously announced in July extends cash trail through Q4 2023
RALEIGH, NC /ACCESSWIRE/August 15, 2022/ 9 Meters Biopharma, Inc. (NASDAQ:NMTR), a clinical-stage company pioneering innovative treatments for people with rare or debilitating digestive diseases, today provided an overview of its recent achievements, milestones ahead and financial results for the second quarter ended June 30, 2022.
John Temperato, President and CEO of 9 Meters Biopharma, said, “The highlight of the second quarter was the announcement of positive preliminary results from the Phase 2 VIBRANT study evaluating vurolenatide in adult patients with short bowel syndrome. We believe these preliminary results support the safety and efficacy of vurolenatide and look forward to our end of phase 2 meeting with the FDA this quarter. Based on the product profile that we believe is supported by our clinical data to date, we believe that vurolenatide has the potential to play a critical role in the first-line treatment of patients with SBS. Pending the results of our meeting with the FDA, we look forward to initiating our phase 3 study with vurolenatide.
Mr. Temperato continued, “In addition, this quarter was also an opportunity to make important and informed decisions regarding larazotide for celiac disease. Although we are disappointed with this result, we are convinced that this is the best decision for the company and its shareholders, and that it will allow us to redirect our financial resources and concentrate all our support on the phase 3 of vurolenatide SBS.
Clinical Development and Commercial Highlights
Announcement of positive preliminary results from the phase 2 study of vurolenatide in short bowel syndrome (SBS)
- On June 30, the Company announced positive preliminary results from the Phase 2 trial known as VIBRANT (VurolenateIto make it short BOwl’s Syndrome Rwhatever pAneed rental assistanceNT) to assess the safety, efficacy and tolerability of vurolenatide in adult patients with SBS.
- Preliminary study results confirm the safety and efficacy of vurolenatide and have identified a dose and dosing range to move into Phase 3 development.
- An end-of-phase 2 meeting with the FDA is on track for Q3 2022.
- A phase 3 study for vurolenatide could start as early as the fourth quarter of 2022 pending the results of the end of phase 2 meeting; study plans including site identification and recruitment are underway.
Interim Analysis of Phase 3 Trial of Larazotide for Celiac Disease
- On June 28, the Company announced that an interim analysis of CedLara® Phase 3 (Thisliar Dit’s a disease Laurazotide) evaluating the safety and efficacy of larazotide in patients with celiac disease did not support continuation of the trial. Following an in-depth analysis of the interim data from the CedLara® study, we are stopping the development of larazotide in celiac disease.
Phase 2a study of larazotide for multisystem inflammatory syndrome in children (MIS-C) resulting from COVID-19 is ongoing
- A phase 2a randomized, double-blind, placebo-controlled study is underway in collaboration with the European Institute for Biomedical Research in Salerno, Italy (EBRIS), which is conducting this study.
Preclinical pipeline update
NM-102 (proprietary tight junction microbiome modulator)
- 9 Meters collaborates with Gustave Roussy, a leading cancer center in France. Gustave Roussy develops preclinical research showing that NM-102 was effective when combined with immune checkpoint inhibitors (ICI) in a mouse model of aggressive cutaneous melanoma and, in combination, improved survival compared to ICI alone. Additional data is expected in 2022.
- The company is also collaborating with NYU Langone Health to investigate the preclinical use of NM-102 for an undisclosed autoimmune disease with significant unmet need.
- Preclinical work is underway to support a possible IND (Investigational New Drug) filing in 2023.
NM-136 (humanized anti-GIP monoclonal antibody)
- NM-136 is a long-acting, highly specific humanized anti-GIP monoclonal antibody. Preclinical work is underway to support a potential IND in 2023.
Second quarter 2022 financial results
As of June 30, 2022, the Company’s cash and cash equivalents totaled approximately $29.5 million, compared to approximately $37.2 million as of March 31, 2022.
On June 30, the Company entered into a senior secured convertible credit facility of up to $70 million as part of an overall financing strategy to support the continued development of vurolenatide for short bowel syndrome by through an NDA submission. The company has raised an initial net amount of $20 million upon closing of the convertible bond on July 15, 2022 and has the option to access up to an additional $50 million in tranches of $5-20 million per quarter over an 18-month period, provided the company meets certain requirements, including raising additional capital.
The Company reported a net loss of approximately $11.1 million, or $0.04 per share, for the second quarter of 2022, compared to a net loss of approximately $11.4 million, or 0, $04 per share, for the first quarter of 2022 and $8.3 million, or $0.03 per share for the second quarter of 2021. The actual change in cash for the second quarter of 2022 was 7. $7 million, the difference between cash and reported earnings being due to non-cash stock compensation expenses and a major equity milestone for EBRIS related to the larazotide study in MIS-C.
Taking into account the initial drawdown of $20 million at the closing of the loan facility, the Company would have a pro forma balance of cash, cash equivalents and restricted cash of $49.5 million at 30 June 2022, and a cash trail expected in the fourth quarter of 2023.
Main milestones planned in the short term
- End of Phase 2 meeting with the FDA, with additional plans and timeline for the Phase 3 study expected to be disclosed by the end of the third quarter.
- The VIBRANT-2 phase 3 study is expected to start in the fourth quarter of 2022.
- Additional data expected from the Phase 2a study of larazotide in MIS-C.
- Additional data expected from the Gustave Roussy Collaboration evaluating NM-102 combined with immune checkpoint inhibitors (ICI) in a mouse model of aggressive cutaneous melanoma.
About 9 Meters Biopharma
9 Meters Biopharma, Inc. is a clinical-stage company pioneering new treatments for people with rare digestive diseases, gastrointestinal disorders with unmet needs, and debilitating disorders in which gut biology is a factor contributory. 9 Meters is developing vurolenatide, a proprietary long-acting Phase 2 GLP-1 agonist, for SBS; larazotide, a tight junction regulator in MIS-C; and several assets close to clinical stage.
For more information, visit www.9meters.com or follow 9 Meters on Twitter, LinkedIn and Facebook.
This press release contains forward-looking statements based on 9 Meters’ current expectations. Forward-looking statements include, but are not limited to, statements that express our intentions, beliefs, expectations, strategies, forecasts, anticipated milestones, and any other statements relating to our future business or other events or future 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 these forward-looking statements due to various risks and uncertainties, which include, but are not limited to: risks relating to our ability to successfully implement our strategic plans , including dependence on our lead product candidate; uncertainties associated with clinical development and regulatory approval of product candidates, including reliance on blinded data; uncertainties regarding the achievement of positive clinical results for product candidates and the unanticipated costs that may result; risks related to 9 Meters’ inability to raise sufficient additional capital to continue to advance these product candidates and its preclinical programs, including in light of current market conditions; risks related to the inability to realize any value from product candidates and preclinical programs in development and planned in light of the inherent risks and challenges of bringing the product candidates to market; intellectual property risks; the impact of COVID-19 on our operations, clinical trial enrollment and timing; risks relating to the Company’s leverage in borrowing money under the Credit Facility and compliance with its terms; Nasdaq delisting risk; dependence on co-workers; dependence on research and development partners; cybersecurity and data privacy risks; and the risks associated with the acquisition and development of 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 titled “Risk Factors” in 9 Meters’ Annual Report on Form 10-K. for the fiscal year ended December 31, 2021, as modified or supplemented by our Quarterly Reports on Form 10-Q and in other filings that 9 Meters has made and in future filings that 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 publicly release any updates or revisions to any forward-looking statements contained herein to reflect any change in its expectations with respect thereto or any change in events, conditions or circumstances about which such statements are based. .
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