Plans to initiate three clinical studies in
chronic cough indications for later this year remain on
track
Data from Phase 2 CANAL trial of chronic cough
in patients with idiopathic pulmonary fibrosis published in NEJM
Evidence
Management to host a conference call and
webcast today at 4:30 p.m.
EDT
NEW
HAVEN, Conn., Aug. 10,
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, today announced financial
results for the quarter ended June 30, 2023, as well as
provided business updates.
Plans to initiate three clinical studies in
chronic cough indications for later this year remain on track
"Our development plans remain on track in our chronic cough
programs and we expect to initiate clinical trials in both chronic
cough in IPF and refractory chronic cough in the second half of
this year," said Jennifer Good,
President and CEO of Trevi Therapeutics. "We are currently in the
regulatory submission phase in various countries to support trial
initiations. We were encouraged by the high degree of scientific
and clinical interest at the medical meetings held this quarter
surrounding our data generated in chronic cough in IPF and the
potential of Haduvio's mechanism of action to broadly treat chronic
cough."
Key Business Updates
- Preparation for the initiation of three chronic cough trials
(Phase 2b dose ranging trial for
treatment of chronic cough in patients with IPF, Phase 1b trial to evaluate respiratory physiology in
patients with IPF, and Phase 2a trial in refractory chronic cough
(RCC)) continues to advance as we work through the regulatory
submission process in multiple countries. All trials are expected
to be initiated in the second half of this year.
- Announced publication of positive data from the Phase 2 CANAL
trial of Haduvio for the treatment of chronic cough in IPF in NEJM
Evidence.
- Working on securing supply of the comparator drug IV
butorphanol to complete the final part of the Human Abuse Potential
study. There was an identified shortage of IV butorphanol due to a
single supplier and recent tornado damage to their manufacturing
plant. This will delay our anticipated year-end results.
- Repaid the outstanding indebtedness under our term loan with a
payment of $6.5 million on
May 9, 2023. The Company ended the
second quarter of 2023 with $94.2
million in cash, cash equivalents and marketable
securities.
Second Quarter 2023 Financial Highlights
Research and development (R&D) expenses: R&D
expenses for the second quarter of 2023 increased to $5.8 million from $5.1
million in the same period in 2022. The increase was
primarily due to higher consulting and professional fees related to
startup activities for the Company's three planned chronic cough
trials as well as an increase in personnel-related expenses.
General and administrative (G&A) expenses: G&A
expenses were $2.5 million in the
second quarter of 2023 compared to $2.7
million in the same period in 2022. The decrease was
primarily due to a reduction in market research costs.
Other income (expense), net: Other income, net was
$1.2 million in the second quarter of
2023 compared to other expense, net of $0.2
million in the same period in 2022. The change was primarily
due to an increase in interest income.
Net loss: For the second quarter of 2023, the Company
reported a net loss of $7.1 million,
compared to a net loss of $8.1
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 6064699. 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:
- Aug 14-16: Stifel Biotech
Executive Summit – Newport,
RI
- Sep 9-13: ERS International
Congress 2023 – Milan, Italy
- Sep 19-21: Cantor Fitzgerald
Global Healthcare Conference 2023 – New
York, NY
- Sep 20-22: 2023 SVB Securities
Biopharma Summit – Montecito,
CA
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 idiopathic pulmonary
fibrosis (IPF), other chronic cough indications, and prurigo
nodularis. 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 disease
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
Enforcement Agency. Trevi intends to propose Haduvio as the trade
name for oral nalbuphine ER. Its safety and efficacy have not been
evaluated by any regulatory authority.
For more information, visit www.TreviTherapeutics.com and
follow Trevi 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 as well as other
risks and uncertainties set forth in the quarterly report on Form
10-Q for the quarter ended June 30,
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)
|
|
|
|
|
|
June 30,
2023
|
|
|
December 31,
2022
|
|
Cash and cash
equivalents
|
|
$
|
13,752
|
|
|
$
|
12,589
|
|
Marketable
securities
|
|
|
80,400
|
|
|
|
107,921
|
|
Working
capital
|
|
|
94,502
|
|
|
|
109,216
|
|
Total assets
|
|
|
100,977
|
|
|
|
123,015
|
|
Total debt
|
|
|
—
|
|
|
|
9,151
|
|
Stockholders'
equity
|
|
|
95,073
|
|
|
|
107,459
|
|
Trevi Therapeutics,
Inc.
|
Selected Statement
of Operations Data
|
(unaudited)
|
(amounts in
thousands, except per share amounts)
|
|
|
|
Three Months
Ended
June 30,
|
|
|
Six Months Ended
June 30,
|
|
|
|
2023
|
|
|
2022
|
|
|
2023
|
|
|
2022
|
|
Operating
expenses:
|
|
|
|
|
|
|
|
|
|
|
|
|
Research and
development
|
|
$
|
5,842
|
|
|
$
|
5,103
|
|
|
$
|
10,842
|
|
|
$
|
9,748
|
|
General and
administrative
|
|
|
2,540
|
|
|
|
2,717
|
|
|
|
5,103
|
|
|
|
5,097
|
|
Total operating
expenses
|
|
|
8,382
|
|
|
|
7,820
|
|
|
|
15,945
|
|
|
|
14,845
|
|
Loss from
operations
|
|
|
(8,382)
|
|
|
|
(7,820)
|
|
|
|
(15,945)
|
|
|
|
(14,845)
|
|
Other income
(expense), net
|
|
|
1,207
|
|
|
|
(236)
|
|
|
|
2,362
|
|
|
|
(545)
|
|
Loss before income
taxes
|
|
|
(7,175)
|
|
|
|
(8,056)
|
|
|
|
(13,583)
|
|
|
|
(15,390)
|
|
Income tax
benefit
|
|
|
30
|
|
|
|
4
|
|
|
|
37
|
|
|
|
9
|
|
Net loss
|
|
$
|
(7,145)
|
|
|
$
|
(8,052)
|
|
|
$
|
(13,546)
|
|
|
$
|
(15,381)
|
|
Basic and diluted net
loss per common
share outstanding
|
|
$
|
(0.07)
|
|
|
$
|
(0.14)
|
|
|
$
|
(0.14)
|
|
|
$
|
(0.34)
|
|
Weighted average common
shares
used in net loss per share attributable
to common stockholders, basic and
diluted
|
|
|
98,698,579
|
|
|
|
59,542,628
|
|
|
|
98,654,868
|
|
|
|
45,253,599
|
|
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.