Trevi Therapeutics (NASDAQ:TRVI) stock observed trading -25.71% off 52-week high price. On the other end, the stock has been noted 9.89% away from low price over the last 52-weeks. The stock disclosed a move of -10.14% away from 50 day moving average and -10.14% away from 200 day moving average. Moving closer, we can see that shares have been trading -11.86% off 20-day moving average. It has market cap of $140.94M .
Trevi Therapeutics (NASDAQ:TRVI), a clinical-stage biopharmaceutical company focused on the development and commercialization of nalbuphine ER to treat serious neurologically mediated conditions, announced financial results for the quarter ended March 31, 2019, as well as recent business highlights.
“The successful completion of our IPO enables Trevi to continue development of nalbuphine ER for the treatment of chronic pruritus, chronic cough in patients with idiopathic pulmonary fibrosis (IPF), and levodopa-induced dyskinesia (LID) in patients with Parkinson’s disease,” said Jennifer L. Good, President and CEO of Trevi Therapeutics. “We plan to report top-line data from our Phase 2b/3 PRISM trial of nalbuphine ER in patients with prurigo nodularis in the first half of 2020. Additionally, the protocol for the PRISM trial provides for a sample size re-estimation analysis once 50% of the patients in the trial are evaluable for the primary endpoint. We expect the re-estimation analysis will occur in early 2020. We are also pleased to announce the initiation of our Phase 2 trial for chronic cough in patients with IPF, a serious condition for IPF patients for which there are no approved therapies.”
First Quarter 2019 Highlights and Recent Events
Activated clinical sites in Europe for the PRISM trial: During the first quarter of 2019 Trevi commenced activation of clinical sites in Europe and have begun enrolling patients in the PRISM trial in Europe.
Initiated Phase 2 trial of nalbuphine ER for chronic cough in patients with IPF in June 2019: The Phase 2 clinical trial is a randomized, double-blind, placebo controlled, two-treatment, two-period, crossover study designed to evaluate the efficacy, safety, tolerability and dosing of nalbuphine ER for chronic cough in up to 56 patients with IPF in the United Kingdom. The primary endpoint for the study is the mean change in daytime cough frequency as measured by a cough monitor. The study will also examine various secondary endpoints. Trevi plans to report top-line data from this trial in the first half of 2020.
Completed initial public offering (IPO): In May 2019, Trevi announced it had completed its IPO of 5,500,000 shares of common stock and a concurrent private placement of 1,500,000 shares of common stock, resulting in combined net proceeds to the Company of approximately $62.6 million after deducting underwriting discounts and commissions and estimated offering expenses. Shares outstanding immediately after the IPO and private placement were approximately 17.8 million.
Licensed patents for use of nalbuphine ER for treatment of LID in Parkinson’s disease: In February 2019, Trevi announced it had entered into exclusive license agreements with Rutgers, The State University of New Jersey and MentiNova for intellectual property and data supporting the development of nalbuphine ER for LID in patients with Parkinson’s disease. Based on feedback from the Food and Drug Administration (FDA) in a pre-IND meeting earlier this year, Trevi plans to submit an IND in preparation for a Phase 2 trial of nalbuphine ER in this indication expected to commence in the second half of 2019.
First Quarter 2019 Financial Highlights
Cash position: As of March 31, 2019, Trevi reported total cash and cash equivalents of $12.9 million, compared to $7.2 million as of December 31, 2018. Subsequent to the quarter, in May 2019, Trevi received approximately $62.6 million of net proceeds from its IPO and concurrent private placement.
Research and development (R&D) expenses: R&D expenses for the first quarter of 2019 were $3.3 million compared to $2.4 million in the same period in 2018. The increase was primarily due to initiation of the Phase 2b/3 PRISM trial in the third quarter of 2018 and an increase in personnel.
General and administrative (G&A) expenses: G&A expenses for the first quarter of 2019 were $1.5 million compared to $0.8 million in the same period in 2018. The increase was primarily due to an increase in personnel and associated stock-based compensation expense as well as consulting and professional fees.
Net loss: For the first quarter of 2019, Trevi reported a net loss of $4.8 million, compared to a net loss of $4.1 million in the same period in 2018.
The USA based company Trevi Therapeutics moved with change of 0.77% to $7.89 with the total traded volume of 1965 shares in recent session versus to an average volume of 149.37K. The stock was observed in the 5 days activity at -16.79%. The one month performance of stock was -12.02%. TRVI’s shares are now at -0.76% since this point in 2018. The average volatility for the week and month was at 11.32% and 9.81% respectively. There are 18M shares outstanding and 16.44M shares are floated in market.