On Tuesday, H.C. Wainwright maintained a Buy rating on Trevi Therapeutics (NASDAQ:TRVI) shares, with a price target of $6.00, highlighting the pharmaceutical company's ongoing progress with its drug Haduvio, an extended-release oral formulation of nalbuphine.
The firm's optimism is rooted in the recent completion of enrollment for the RIVER Phase 2a trial for refractory chronic cough—a condition with no approved treatments and a significant market potential. Topline data from this trial is anticipated by February 2025.
The analyst's remarks follow Trevi's announcement on Monday, detailing the latest developments in its drug pipeline. These include the expected results from the Human Abuse Potential (HAP) study in December, which will assess nalbuphine's potential for abuse compared to butorphanol, and a sample size re-estimation update for the CORAL Phase 2b trial in chronic cough associated with idiopathic pulmonary fibrosis (CC-IPF), also expected in December.
Trevi's CANAL Phase 2a trial in CC-IPF previously exhibited substantial cough reduction, which the analyst believes may be due to Haduvio's mechanism of action that targets both central and peripheral pathways. The anticipation is that the upcoming results from the RIVER Phase 2a and CORAL Phase 2b trials will be favorable when compared to placebo.
The firm's valuation of Trevi Therapeutics at an enterprise value of $269 million is seen as potentially undervalued, especially when considering the acquisition of Bellus Health by GSK (LON:GSK) last year for $2 billion. Bellus's product, camlipixant, also aimed at treating refractory chronic cough, was in Phase 3 with less impressive Phase 2 results than those seen in Trevi's CANAL CC-IPF Phase 2a.
H.C. Wainwright's price target of $6.00 for Trevi Therapeutics reflects a blended probability of success of approximately 40% for Haduvio. The drug's forecasted peak sales are estimated at around $650 million for CC-IPF and a combined $650 million for RCC, in addition to potential partner royalties.
In other recent news, Trevi Therapeutics has made significant strides in its clinical trials, including the completion of patient enrollment for its Phase 2a RIVER trial. The trial is assessing the efficacy of Haduvio for the treatment of refractory chronic cough, with top-line data expected in the first quarter of 2025.
Moreover, the company's Phase 2b CORAL trial has reached 50% of its enrollment target. Despite a reported net loss of $12.4 million, Trevi Therapeutics continues to advance several trials, with funding secured until 2026.
Analyst firms, including Oppenheimer, B.Riley, Raymond James, H.C. Wainwright, and EF Hutton, have maintained positive ratings on Trevi Therapeutics. Oppenheimer reaffirmed its Outperform rating following an update from Trevi's management regarding the timeline for clinical results of Haduvio. These are recent developments in the company's ongoing efforts to develop treatments for chronic cough conditions.
InvestingPro Insights
Trevi Therapeutics' financial landscape offers a mixed picture that complements the clinical progress highlighted in the article. According to InvestingPro data, the company's market capitalization stands at $243.18 million, which aligns with the analyst's enterprise value estimate of $269 million mentioned in the article. This valuation could indeed be conservative if Haduvio's clinical trials prove successful.
An InvestingPro Tip reveals that Trevi holds more cash than debt on its balance sheet, which is crucial for a pharmaceutical company in the development stage. This financial stability could provide the necessary runway for Trevi to complete its ongoing clinical trials, including the RIVER Phase 2a and CORAL Phase 2b studies mentioned in the article.
Despite the positive outlook on Haduvio's potential, another InvestingPro Tip indicates that net income is expected to drop this year. This is not uncommon for biotech companies investing heavily in R&D, and it aligns with the article's focus on future potential rather than current profitability.
The stock's performance has been strong, with a year-to-date price total return of 150% as of the latest data. This significant increase suggests that investors are optimistic about Trevi's pipeline, particularly the progress of Haduvio in addressing unmet medical needs like refractory chronic cough.
For investors seeking a more comprehensive analysis, InvestingPro offers additional tips and metrics that could provide deeper insights into Trevi Therapeutics' financial health and market position.
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