Trevi Therapeutics Announces Second Quarter 2020 Financial Results and Business Update
August 13 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 June 30, 2020, as well as recent
business updates.
“We are pleased with how the Trevi team was able to manage the
continued execution of the PRISM trial in the face of the COVID-19
pandemic restrictions. The Company announced the positive outcome
of the sample size re-estimation analysis and continued to activate
clinical sites virtually,” said Jennifer L. Good, President and CEO
of Trevi Therapeutics. “Once the screening and enrollment
restrictions were lifted in the PRISM trial, we were able to
rapidly restart screening and enrollment in most of our sites. We
now have approximately 80% of our sites screening patients and have
had our strongest two months of enrollment thus far in the trial.
In addition, we are pleased to announce the execution of a
non-dilutive $14 million term loan which we expect will extend our
cash runway into the first half of 2022, past the anticipated
top-line results from the PRISM trial which are expected in the
fourth quarter of 2021.”
Key Business Updates
- Phase 2b/3 PRISM trial of Haduvio for severe pruritus
in patients with prurigo nodularis: The Company completed
the pre-specified sample size re-estimation (SSRE) analysis in July
and based on the recommendation of the independent Data Monitoring
Committee, we increased the trial size from the initial target
enrollment of 240 to 360 subjects to maintain statistical power for
the primary endpoint. The pace of enrollment has accelerated since
the removal of most COVID-19 screening and enrollment restrictions
and approximately 155 subjects have been enrolled in the study. We
expect to complete enrollment in the third quarter of 2021 and
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 is amending the study protocol to reduce the number of
in-person visits to facilitate this study being completed in an
at-risk patient population for COVID-19. The Company is
planning for a restart of this trial in the second half of
2020.
- Entered into $14 million term loan with Silicon Valley
Bank: The Company entered into a $14 million term loan
with Silicon Valley Bank on August 13, 2020 which will bolster our
balance sheet and extends our cash runway into the first half of
2022. The term loan requires monthly interest-only payments through
February 28, 2022, followed by monthly payments of principal and
interest until February 1, 2024. Interest on the term loan
initially accrues at a floating per annum rate of the greater of
(i) the prime rate plus 1.0% and (ii) 4.25%. Other material terms
related to the term loan can be found in the Company’s Form
10-Q.
Second Quarter 2020 Financial Highlights
Cash position: As of June 30, 2020, the Company
had total cash and cash equivalents of $44.2 million, compared to
$57.3 million as of December 31, 2019.
Research and development (R&D) expenses:
R&D expenses for the second quarter of 2020 were $4.9 million
compared to $5.5 million in the same period in 2019. The decrease
was primarily due to decreased activity in our Phase 2 trial in
chronic cough in patients with IPF due to the halting of enrollment
and treatment of patients as a result of the COVID-19 pandemic.
General and administrative (G&A) expenses:
G&A expenses for the second quarter of 2020 were $2.5 million
compared to $1.9 million in the same period in 2019. The increase
was primarily due to an increase in stock-based compensation
expenses and an increase in expenses related to being a public
company.
Net loss: For the second quarter of 2020, the
Company reported a net loss of $7.4 million, compared to a net loss
of $7.3 million in the same period in 2019.
Conference CallAs previously announced, the
Company will host a conference call and webcast today, August 13,
2020 at 4:30 p.m. ET. To participate in the live conference call by
phone, please dial 866-360-5746 (domestic) or 270-833-1418
(international) and provide access code 8162375. 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 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 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 our 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; 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 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 our cash runway, future
expenses and other financial results; as well as other risks and
uncertainties set forth in the annual report on Form 10-Q for the
quarter ended March 31, 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)
|
June 30, 2020 |
|
December 31, 2019 |
|
|
|
|
Cash and cash equivalents |
$ |
44,180 |
|
$ |
57,313 |
Working capital |
|
39,573 |
|
54,353 |
Total assets |
|
47,009 |
|
60,001 |
Stockholders' equity |
|
40,037 |
|
54,545 |
|
|
|
|
|
Trevi Therapeutics, Inc.
Selected Statement of Operations
Data
(unaudited)
(amounts in thousands)
|
Three Months Ended June 30, |
|
Six Months Ended June 30, |
|
2020 |
|
2019 |
|
2020 |
|
2019 |
|
|
|
|
|
|
|
|
Operating expenses: |
|
|
|
|
|
|
|
Research and development |
$ |
4,921 |
|
$ |
5,528 |
|
$ |
10,940 |
|
$ |
8,866 |
General and administrative |
2,492 |
|
1,889 |
|
5,112 |
|
3,363 |
Total operating expenses |
7,413 |
|
7,417 |
|
16,052 |
|
12,229 |
Loss from operations |
(7,413) |
|
(7,417) |
|
(16,052) |
|
(12,229) |
Other income (expense), net |
14 |
|
66 |
|
171 |
|
72 |
Loss before income tax
benefit |
(7,399) |
|
(7,351) |
|
(15,881) |
|
(12,157) |
Income tax benefit |
15 |
|
5 |
|
24 |
|
9 |
Net loss |
$ |
(7,384) |
|
$ |
(7,346) |
|
$ |
(15,857) |
|
$ |
(12,148) |
|
|
|
|
|
|
|
|
Investor ContactChris Seiter, Chief Financial
OfficerTrevi Therapeutics,
Inc.chris.seiter@trevitherapeutics.com203-304-2499
Media ContactRosalia Scampoli
rscampoli@marketcompr.com914-815-1465
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