Initiating three clinical studies
in chronic cough indications later this year
Received Notice of Allowance for key U.S.
patent for the use of oral nalbuphine ER for the treatment of
chronic cough in idiopathic pulmonary fibrosis
Management to host a conference call and
webcast today at 4:30 p.m.
EDT
NEW
HAVEN, Conn., May 11, 2023
/PRNewswire/ -- Trevi Therapeutics, Inc. (Nasdaq: TRVI),
a clinical-stage biopharmaceutical company developing the
investigational therapy Haduvio™ (oral nalbuphine ER) for difficult
to treat patients with chronic cough in idiopathic pulmonary
fibrosis (IPF), other chronic cough indications and prurigo
nodularis (PN), today announced financial results for the quarter
ended March 31, 2023, as well as provided business
updates.
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"We have been focused on progressing our clinical development
plans as we work to initiate clinical trials in both chronic
cough in IPF and in refractory chronic cough as well as advance our
human abuse potential study," said Jennifer
Good, President and CEO of Trevi Therapeutics. "Our efforts
remain on track with the completion of the open-label extension
trial for PN and part 1 of the human abuse potential study in the
first quarter, as well as advancing key activities to initiate the
trials in each of the chronic cough indications in the second half
of this year."
Key Business Updates
- Chronic cough trials:
-
- Phase 2b dose ranging trial for
the treatment of chronic cough in IPF is expected to initiate in
the second half of 2023.
- Phase 1b trial to evaluate the
effect on respiratory physiology in IPF patients is expected to
initiate in the second half of 2023.
- Phase 2a trial in refractory chronic cough is expected to
initiate in the third quarter of 2023.
- Completed part 1 of the human abuse potential study
characterizing butorphanol and selected a butorphanol dose for part
2.
- Received Notice of Allowance for U.S. patent application
covering the use of nalbuphine ER for the treatment of chronic
cough in IPF. Trevi expects the resulting patent will be eligible
for listing in the Orange Book with an anticipated expiration in
2039.
- Completed the open-label extension portion of the Phase
2b/3 PRISM trial for the treatment of
prurigo nodularis during the first quarter of 2023. Data from the
extension study is being analyzed and the Company will request an
End of Phase 2 meeting with the FDA to discuss the program.
- The Company ended the first quarter of 2023 with $111.3 million in cash, cash equivalents and
marketable securities.
First Quarter 2023 Financial Highlights
Research and development (R&D) expenses: R&D
expenses for the first quarter of 2023 increased to $5.0 million from $4.6
million in the same period in 2022. The increase was
primarily due to increased consulting and professional fees related
to startup activities for the three planned chronic cough trials.
This increase was partially offset by a decrease in clinical
development expenses reflecting the completion prior to the first
quarter of 2023 of both the blinded portion of the Phase
2b/3 PRISM trial and the Phase 2
CANAL trial for the treatment of chronic cough in IPF.
General and administrative (G&A) expenses: G&A
expenses were $2.6 million in the
first quarter of 2023 compared to $2.4
million in the same period in 2022. The increase was
primarily due to an increase in personnel-related expenses and
higher tax professional fees.
Other income (expense), net: Other income, net was
$1.2 million in the first quarter of
2023 compared to other expense, net of $0.3
million in the same period in 2022. The change was primarily
due to an increase in interest income.
Net loss: For the first quarter of 2023, the Company
reported a net loss of $6.4 million,
compared to a net loss of $7.3
million in the same period in 2022.
Conference Call/Webcast
To participate in today's live
conference call by phone, please dial (888) 317 6003 (domestic) or
(412) 317 6061 (international) and provide access code 0161285. 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.
Upcoming Meetings
The Company plans to participate in
the following upcoming conferences and events:
- May 19-20: American Thoracic
Society's (ATS) 2023 Respiratory Innovation Summit
- May 19-24: ATS 2023 International Conference
- May 31-June 1: Yale Innovation
Summit 2023
- June 5-8: 2023: BIO International
Convention
- June 9-10: 2023: American Cough
Conference
About Trevi Therapeutics, Inc.
Trevi Therapeutics,
Inc. is a clinical-stage biopharmaceutical company developing the
investigational therapy Haduvio™ (oral nalbuphine ER) for difficult
to treat patients with chronic cough in IPF, other chronic cough
indications, and PN. Haduvio is a dual ĸ-opioid receptor agonist
and µ-opioid receptor antagonist that works both centrally as well
as peripherally in the lungs and has the potential for a
synergistic anti-tussive effect to treat chronic cough.
The impact of chronic cough is significant and often leads to a
decline in patients' social, physical, and psychological quality of
life. There are no approved therapies for the treatment of chronic
cough in IPF and current treatment options provide minimal relief
to patients. In IPF, chronic cough may lead to worsening fibrosis
and may be associated with a higher risk of progression, death, or
need for lung transplant.
Parenteral nalbuphine is not scheduled by the US Drug and
Enforcement Agency. Trevi intends to propose Haduvio as the trade
name for nalbuphine ER. Its safety and efficacy have not been
evaluated by any regulatory authority.
For more information, visit www.TreviTherapeutics.com and
follow the Company on Twitter and LinkedIn.
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 Trevi's business plans and objectives,
including future plans or expectations for Haduvio and plans and
timing with respect to future clinical trials, 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; the risk that positive data from a clinical trial
may not necessarily be predictive of the results of future clinical
trials in the same or a different indication; uncertainties
regarding Trevi's ability to execute on its strategy; uncertainties
with respect to regulatory authorities' views as to the data from
Trevi's clinical trials and next steps in the development path for
Haduvio in the United States and
foreign countries, including Trevi's ability to submit and get
clearance of an IND and other regulatory filings on a timely basis;
uncertainties inherent in estimating Trevi's cash runway, future
expenses and other financial results, including Trevi's ability to
fund future operations, including 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; as well as other
risks and uncertainties set forth in the quarterly report on Form
10-Q for the quarter ended March 31,
2023 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)
|
|
|
|
March 31,
2023
|
|
|
December 31,
2022
|
|
Cash and cash
equivalents
|
|
$
|
11,651
|
|
|
$
|
12,589
|
|
Marketable
securities
|
|
|
99,607
|
|
|
|
107,921
|
|
Working
capital
|
|
|
101,000
|
|
|
|
109,216
|
|
Total assets
|
|
|
116,205
|
|
|
|
123,015
|
|
Total debt
|
|
|
7,482
|
|
|
|
9,151
|
|
Stockholders'
equity
|
|
|
101,732
|
|
|
|
107,459
|
|
Trevi Therapeutics,
Inc.
|
Selected Statement
of Operations Data
|
(unaudited)
|
(amounts in
thousands, except per share amounts)
|
|
|
|
Three Months
Ended
March 31,
|
|
|
|
2023
|
|
|
2022
|
|
Operating
expenses:
|
|
|
|
|
|
|
Research and
development
|
|
$
|
5,000
|
|
|
$
|
4,645
|
|
General and
administrative
|
|
|
2,563
|
|
|
|
2,380
|
|
Total operating
expenses
|
|
|
7,563
|
|
|
|
7,025
|
|
Loss from
operations
|
|
|
(7,563)
|
|
|
|
(7,025)
|
|
Other income
(expense), net
|
|
|
1,155
|
|
|
|
(309)
|
|
Loss before income
taxes
|
|
|
(6,408)
|
|
|
|
(7,334)
|
|
Income tax
benefit
|
|
|
7
|
|
|
|
5
|
|
Net loss
|
|
$
|
(6,401)
|
|
|
$
|
(7,329)
|
|
Basic and diluted net
loss per common share outstanding
|
|
$
|
(0.06)
|
|
|
$
|
(0.24)
|
|
Weighted average common
shares used in net
loss per share attributable to common
stockholders, basic and diluted
|
|
|
98,610,671
|
|
|
|
30,805,804
|
|
Investor Contact
Katie
McManus
Trevi Therapeutics, Inc.
203-304-2499
k.mcmanus@trevitherapeutics.com
Media Contact
Rosalia
Scampoli
914-815-1465
rscampoli@marketcompr.com
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SOURCE Trevi Therapeutics, Inc.