The Trevi Therapeutics (NASDAQ: TRVI) share price is up 25% in pre-market trading.
Read on to decide if this is a stock worth investing in.
What is Trevi Therapeutics?
Trevi Therapeutics Inc. is a clinical-stage biopharma company. The company is currently developing investigational pain reduction therapy Haduvio™ (nalbuphine ER) for treating neurological conditions including chronic pruritus, chronic cough in patients with idiopathic pulmonary fibrosis (IPF) and levodopa-induced dyskinesia in patients with Parkinson's disease.
Trevi Therapeutics Inc. is based in New Haven, Connecticut.
Positive Trial Results
Prurigo nodularis is a neuropathic itch that results from nervous system damage rather than issues with the skin. A lack of treatment causes anxiety in patients who struggle to find any form of relief from the unbearable itching sensation.
On 29 June, Trevi announced positive results of its Phase 2b/3 double-blind PRISM study. This trial of its investigational therapy Haduvio™ in treating prurigo nodularis met its primary and critical secondary endpoints.
Jennifer Good, President and CEO of Trevi Therapeutics, said:
We are very pleased to announce the statistically significant results for Haduvio from the PRISM trial, the first and only oral therapy to demonstrate in a clinical trial a positive result in treating prurigo nodularis,
This positive trial in prurigo nodularis, along with the highly statistically significant data from the interim analysis of our Phase 2 trial in IPF chronic cough that we presented earlier this year, further supports our belief that Haduvio could potentially benefit patients across a broad range of refractory chronic pruritic and cough conditions.
Phase 2 Haduvio Clinical Trial for Chronic Cough
Trevi Therapeutics Inc. is also conducting a Phase 2 clinical trial of Haduvio for chronic cough in adults with IPF.
This is known as the Phase 2 CANAL trial and is a randomized, double-blind, placebo-controlled, two-treatment, two-period, crossover study designed to evaluate the efficacy, safety, tolerability and dosing of Haduvio for chronic cough in adults with IPF.
The trial is being conducted at multiple sites in the United Kingdom. In total, the company enrolled approximately 40 subjects in the study. Trevi expects to report efficacy and safety data for this trial's complete set of subjects in Q3, 2022.
How Does Trevi Therapeutics Make Money?
To date, Trevi Therapeutics has not generated any revenues from product sales. The company is at the development stage and has thus far financed its operations primarily through private share placements, IPO, and borrowings.
The company has dedicated its financial resources and efforts to the clinical development of its product candidate Haduvio and related activities.
TRVI Stock Financials
The company expects to have approximately $78m in cash and investments on 30 June 2022.
Trevi currently has a market cap of $94m. Its price-to-book value (P/BV) is 5.9, higher than the industry average of 1.
In April, Nea Management Co. LLC increased its ownership in TRVI stock to 37.15%. Meanwhile, Frazier Life Sciences Management took a 6.75% ownership stake.
TRVI Growth Potential
After the company completes its analysis of the full dataset and discusses its findings with the FDA, it expects to provide further details on Haduvio's development pathway later this year.
TRVI Stock Risks
Development stage biotech stocks require substantial cash to keep research and trials running. This means TRVI stock is a risky investment, and extreme volatility is expected. Nevertheless, the rewards could prove worth the risk if a significant breakthrough or marketable product.
Should You Invest in Trevi Therapeutics?
Whether you should invest in TRVI stock depends on your risk appetite.
In May, Oppenheimer analyst Leland Gershell initiated a Buy rating on TRVI stock with a target share price of $10.