Full Press Release Details
TREVI THERAPEUTICS ANNOUNCES SECOND QUARTER 2019 FINANCIAL RESULTS
AND RECENT BUSINESS DEVELOPMENTS
Advancement of Nalbuphine ER Through Clinical Development in Multiple Indications
New Haven, CT, August 12, 2019 Trevi Therapeutics, Inc. (Nasdaq: TRVI), a clinical-stage biopharmaceutical company focused on the development
and commercialization of nalbuphine ER to treat serious neurologically mediated conditions, today announced financial results for the quarter ended June 30, 2019, as well as recent business highlights.
We are pleased with the progress we made during the first half of 2019 advancing the development of nalbuphine ER and positioning Trevi for several
important clinical milestones later this year and in 2020, said Jennifer L. Good, President and CEO of Trevi Therapeutics. We remain on track to report top-line data from both our Phase 2b/3 PRISM
trial of nalbuphine ER in patients with prurigo nodularis and from our Phase 2 trial of nalbuphine ER for the treatment of chronic cough in patients with idiopathic pulmonary fibrosis (IPF) in the first half of 2020. In addition, we remain on track
to report data from our Phase 1b liver study of nalbuphine ER and initiate our Phase 2 study of nalbuphine ER for the treatment of levodopa-induced dyskinesia (LID) in patients with Parkinson s disease in the second half of 2019.
Second Quarter 2019 Highlights and Recent Events
Second Quarter 2019 Financial Highlights
Cash position: As of June 30, 2019, Trevi reported total cash and cash equivalents of $71.4 million, compared to $7.2 million as of
December 31, 2018. Trevi believes this cash position will fund operations through the end of 2020.
Research and development (R&D)
expenses: R&D expenses for the second quarter of 2019 were $5.5 million compared to $3.4 million in the same period in 2018. The increase was primarily due to increased activities of the Phase 2b/3 PRISM trial and the initiation of
the Phase 2 trial for chronic cough in patients with IPF.
General and administrative (G&A) expenses: G&A expenses for the second quarter
of 2019 were $1.9 million compared to $0.9 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 expenses related to being a public
Net loss: For the second quarter of 2019, Trevi reported a net loss of $7.3 million, compared to a net loss of $4.9 million in
the same period in 2018.
About Trevi Therapeutics, Inc.
Trevi Therapeutics, Inc. is a clinical-stage biopharmaceutical company focused on the development and commercialization of nalbuphine ER to treat serious
neurologically mediated conditions. Trevi is currently developing 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. These conditions share a common pathophysiology that is mediated through opioid receptors in the central and peripheral nervous systems. Trevi is currently conducting a Phase 2b/3 clinical trial of nalbuphine ER, referred
to as the PRISM trial, in patients with severe pruritus associated with prurigo nodularis.
Founded in 2011, Trevi Therapeutics is headquartered
Nalbuphine ER is an oral extended release formulation of nalbuphine. Nalbuphine is a mixed -opioid receptor agonist and -opioid receptor
antagonist that has been approved and marketed as an injectable for pain indications for more than 20 years in the United States and Europe. The - and -opioid receptors are known to be critical mediators of itch, cough and certain
movement disorders. Nalbuphine s mechanism of action also mitigates the risk of abuse associated with -opioid agonists because it antagonizes, or blocks, -opioid receptors. Nalbuphine is currently the only opioid approved for
marketing that is not classified as a controlled substance in the United States and most of Europe.
Forward-Looking Statements
Statements contained in this press release regarding matters that are not historical facts are forward-looking statements within the meaning of the
Private Securities Litigation Reform Act of 1995. Such statements are subject to risks and uncertainties, actual results may differ materially from those expressed or implied by such forward-looking statements. Such statements include, but are not
limited to, statements regarding the expected timing of the re-estimation analysis for, and for reporting top-line
data from, Trevi s Phase 2b/3 PRISM trial of nalbuphine ER in patients with prurigo nodularis; the expected timing of milestones for the Company s other ongoing and planned clinical
trials; Trevi s business plans and objectives, including future plans or expectations for Trevi s product candidates and expectations regarding Trevi s uses and sufficiency of capital; and other statements containing the words
believes, anticipates, plans, expects, and similar expressions. Risks that contribute to the uncertain nature of the forward-looking statements include: uncertainties regarding the success, cost, and
timing of the Trevi s product candidate development activities and planned clinical trials; uncertainties regarding Trevi s ability to execute on its strategy; the risk that positive results from a clinical trial may not necessarily be
predictive of the results of future or ongoing clinical trials; potential regulatory developments in the United States and foreign countries; uncertainties inherent in estimating future expenses, capital requirements and other financial results; as
well as the other risks and uncertainties set forth in the quarterly report on Form 10-Q for the quarter ended March 31, 2019 filed with the Securities and Exchange Commission and in subsequent filings
with the Securities and Exchange Commission. All forward-looking statements contained in this press release speak only as of the date on which they were made. Trevi undertakes no obligation to update such statements to reflect events that occur or
circumstances that exist after the date on which they were made.
Trevi Therapeutics, Inc.
Selected Balance Sheet Data
| June 30, 2019 | December 31, 2018 | |||||||
| Cash and cash equivalents | $ | 71,387 | $ | 7,202 | ||||
| Working capital | 67,503 | 6,148 | ||||||
| Total assets | 75,116 | 10,526 | ||||||
| Stockholders equity (deficit) | 67,703 | (109,494 | ) |
Trevi Therapeutics, Inc.
Selected Statement of Operations Data
| Three Months Ended June 30, | Six Months Ended June 30, | |||||||||||||||
| 2019 | 2018 | 2019 | 2018 | |||||||||||||
| Operating expenses: | ||||||||||||||||
| Research and development | $ | 5,528 | $ | 3,439 | $ | 8,866 | $ | 5,802 | ||||||||
| General and administrative | 1,889 | 941 | 3,363 | 1,720 | ||||||||||||
| Total operating expenses | 7,417 | 4,380 | 12,229 | 7,522 | ||||||||||||
| Loss from operations | (7,417 | ) | (4,380 | ) | (12,229 | ) | (7,522 | ) | ||||||||
| Other income (expense), net | 66 | (503 | ) | 72 | (1,437 | ) | ||||||||||
| Loss before income tax benefit | (7,351 | ) | (4,883 | ) | (12,157 | ) | (8,959 | ) | ||||||||
| Income tax benefit | 5 | 25 | 9 | 50 | ||||||||||||
| Net loss | $ | (7,346 | ) | $ | (4,858 | ) | $ | (12,148 | ) | $ | (8,909 | ) |