Trevi Therapeutics Announces Third Quarter 2020 Financial Results and Business Update
November 11 2020 - 4:05PM
Trevi Therapeutics, Inc. (Nasdaq: TRVI), a clinical-stage
biopharmaceutical company focused on the development and
commercialization of Haduvio™ (nalbuphine ER) to treat serious
neurologically mediated conditions, today announced financial
results for the quarter ended September 30, 2020, as well as
business updates.
“We are pleased with the continued progress of our clinical
development programs,” said Jennifer L. Good, President and
CEO of Trevi Therapeutics. “We recently announced significant
developments in both of our ongoing clinical trials by surpassing
halfway enrollment in our PRISM trial and enrolling the first new
subject in our chronic cough trial in IPF since the study resumed
after pausing due to COVID restrictions. We are focused on
completing enrollment in both trials and preparing for the next
steps in the development of Haduvio.”
Key Business Updates
- Phase 2b/3 PRISM trial of
Haduvio for severe pruritus in patients
with prurigo nodularis:
The Company has enrolled approximately 190 subjects in the trial
and reaffirms its guidance that it expects to complete enrollment
in the third quarter of 2021 and to report top-line data in the
fourth quarter of 2021.
- Phase 2 trial of Haduvio
for chronic cough in patients with idiopathic pulmonary
fibrosis (IPF): The Company resumed screening and
enrolling patients in the trial following the pause in the trial
due to COVID-19. The Company amended the study protocol to require
fewer in-person visits by subjects as well as fewer procedures in
order to facilitate the completion of the trial in an at-risk
patient population for COVID-19. Additionally, the Company is
assessing additional study sites in Germany which could potentially
accelerate enrollment and reduce the risks inherent with
single-country recruitment during the COVID-19 pandemic.
Third Quarter 2020 Financial Highlights
Cash position: As of September 30, 2020, the
Company had total cash and cash equivalents of $53.3 million,
compared to $57.3 million as of December 31, 2019. During the third
quarter of 2020, the Company received $14.0 million in proceeds
from a term loan with Silicon Valley Bank and sold approximately
$2.5 million of common stock under the Company’s ATM program. The
Company expects its cash position will fund operations into the
first half of 2022.
Research and development (R&D) expenses:
R&D expenses for the third quarter of 2020 were $4.8 million
compared to $5.7 million in the same period in 2019. The decrease
was primarily due to decreased activity in the Company’s Phase 2
trial in chronic cough in patients with IPF due to the pausing of
enrollment and treatment of patients as a result of the COVID-19
pandemic as well as decreased activity with the completion of the
Company’s Phase 1b trial in patients with chronic liver
disease.
General and administrative (G&A) expenses:
G&A expenses for the third quarter of 2020 were $2.4 million
compared to $2.0 million in the same period in 2019. The increase
was primarily due to an increase in stock-based compensation
expenses and an increase in consulting fees.
Net loss: For the third quarter of 2020, the
Company reported a net loss of $7.4 million, compared to a net loss
of $7.4 million in the same period in 2019.
Conference CallAs previously announced, the
Company will host a conference call and webcast today, November 11,
2020 at 4:30 p.m. ET. To participate in the live conference call by
phone, please dial (866) 360-5746 (domestic) or (602) 563-8605
(international) and provide access code 9375955. A live audio
webcast will be accessible from the ‘Investors & News’ section
on the Company’s website at www.trevitherapeutics.com. An archived
replay of the webcast will also be available for 30 days on the
Company’s website following the event.
About Trevi
Therapeutics, Inc.Trevi Therapeutics, Inc. is
a clinical-stage biopharmaceutical company focused on the
development and commercialization of Haduvio to treat serious
neurologically mediated conditions. Trevi is currently developing
Haduvio 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 Haduvio, referred to as the PRISM trial, in
patients with severe pruritus associated with prurigo
nodularis.
Founded in 2011, Trevi Therapeutics is headquartered
in New Haven, CT.
About HADUVIO Haduvio is an oral extended
release formulation of nalbuphine. Nalbuphine is a mixed ĸ-opioid
receptor agonist and µ-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 ĸ- and
µ-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 µ-opioid
agonists because it antagonizes, or blocks, µ-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. Trevi intends to propose Haduvio as the trade
name for the nalbuphine ER investigational product. Haduvio is an
investigational drug product and its safety and efficacy have not
been fully evaluated by any regulatory authority.
Forward-Looking StatementsStatements 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 and 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 impact of the COVID-19
pandemic on Trevi’s clinical trials, business and operations; the
expected timing of enrollment and for reporting top-line data from,
Trevi’s Phase 2b/3 PRISM trial of Haduvio in patients with prurigo
nodularis; 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 Trevi’s
product candidate development activities and ongoing and planned
clinical trials; uncertainties regarding the scope, timing and
severity of the COVID-19 pandemic, the impact of the COVID-19
pandemic on Trevi’s clinical operations and actions taken in
response to the pandemic; 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 Trevi’s cash runway, future
expenses and other financial results; as well as other risks and
uncertainties set forth in the quarterly report on Form 10-Q for
the quarter ended June 30, 2020 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
(unaudited)
(amounts in thousands)
|
September 30,2020 |
|
December 31,2019 |
|
|
|
|
Cash and cash equivalents |
$ |
53,293 |
|
$ |
57,313 |
Working capital |
|
49,106 |
|
54,353 |
Total assets |
|
55,879 |
|
60,001 |
Total debt |
|
13,798 |
|
── |
Stockholders' equity |
|
35,618 |
|
54,545 |
Trevi Therapeutics,
Inc.
Selected Statement of Operations
Data
(unaudited)
(amounts in thousands)
|
Three Months EndedSeptember
30, |
|
Nine Months EndedSeptember
30, |
|
2020 |
|
2019 |
|
2020 |
|
2019 |
|
|
|
|
|
|
|
|
Operating expenses: |
|
|
|
|
|
|
|
Research and development |
$ |
4,828 |
|
|
$ |
5,650 |
|
|
$ |
15,768 |
|
|
$ |
14,516 |
|
General and administrative |
|
2,416 |
|
|
|
2,000 |
|
|
|
7,528 |
|
|
|
5,363 |
|
Total operating expenses |
|
7,244 |
|
|
|
7,650 |
|
|
|
23,296 |
|
|
|
19,879 |
|
Loss from operations |
|
(7,244 |
) |
|
|
(7,650 |
) |
|
|
(23,296 |
) |
|
|
(19,879 |
) |
Other income (expense), net |
|
(145 |
) |
|
|
280 |
|
|
|
26 |
|
|
|
352 |
|
Loss before income tax
benefit |
|
(7,389 |
) |
|
|
(7,370 |
) |
|
|
(23,270 |
) |
|
|
(19,527 |
) |
Income tax benefit |
|
11 |
|
|
|
5 |
|
|
|
35 |
|
|
|
14 |
|
Net loss |
$ |
(7,378 |
) |
|
$ |
(7,365 |
) |
|
$ |
(23,235 |
) |
|
$ |
(19,513 |
) |
Investor ContactChris Seiter, Chief Financial
OfficerTrevi Therapeutics,
Inc.203-304-2499chris.seiter@trevitherapeutics.com
Media Contact
Rosalia Scampoli914-815-1465rscampoli@marketcompr.com
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