Topline results expected in the fourth quarter of
2024 in the Phase 2a RIVER trial in refractory chronic cough
(RCC)
Sample size re-estimation milestone is expected
in the fourth quarter of 2024 in the Phase 2b CORAL trial in chronic cough in idiopathic
pulmonary fibrosis (IPF)
Ended the second quarter of 2024 with
$69.5 million in cash, cash
equivalents and marketable securities with expected cash runway
into 2026
Management to host a conference call and webcast
today at 4:30 p.m. ET
NEW
HAVEN, Conn., Aug. 8, 2024
/PRNewswire/ -- Trevi Therapeutics, Inc. (Nasdaq: TRVI), a
clinical-stage biopharmaceutical company developing the
investigational therapy Haduvio™ (oral nalbuphine ER) for the
treatment of chronic cough in idiopathic pulmonary fibrosis (IPF)
and refractory chronic cough (RCC), today announced financial
results for the quarter ended June 30, 2024, as well as
provided business updates.
"Recruitment in our clinical trials was strong during the
quarter," said Jennifer Good,
President and CEO of Trevi Therapeutics. "Our Phase 2a RIVER trial
in RCC is now approximately 80% enrolled and we look forward to the
topline data readout later this year. We also expect to complete
the sample size re-estimation in our CORAL trial in the fourth
quarter of this year. There is a significant unmet need for new
therapies to help IPF and RCC patients. Chronic cough is a
condition that is prevalent in 120,000 IPF patients and an
estimated 2-3 million RCC patients in the U.S. and for which there
are no approved therapies. We believe Haduvio's unique central and
peripheral mechanism has the potential to provide a rapid, broad,
and deep effect in those suffering from chronic cough."
Second Quarter and Recent Business Highlights
- In the Phase 2a RIVER trial for the treatment of RCC,
approximately 80% of the planned 60 patients have been enrolled.
The Company expects topline data in the fourth quarter of
2024.
- In the Phase 2b CORAL trial for
the treatment of chronic cough in patients with IPF, in which the
Company expects to enroll approximately 160 patients, the majority
of the 60 planned sites have been initiated. The Company expects to
conduct the sample size re-estimation (SSRE) in the fourth quarter
of this year when 50% of the patients are evaluable for the primary
endpoint. Assuming no adjustments are made to the sample size,
topline results are expected in the first half of 2025.
- Other supportive studies:
- The Human Abuse Potential (HAP) study is now approximately 95%
enrolled and the last patient visit is expected by the end of
September. Topline data is expected in the fourth quarter of
2024.
- The Phase 1b TIDAL respiratory
physiology study is approved to be conducted in the UK and US and
we have initiated screening. The study will evaluate the effect of
Haduvio on respiratory physiology in patients with IPF of varying
disease severity. TIDAL is a randomized, single-blind,
placebo-controlled study. We expect to enroll approximately 25
patients who will be in-patient for ten days. The primary endpoint
of the study is the effect of escalating doses of Haduvio on
respiratory function, as measured by minute ventilation. Secondary
endpoints of additional respiratory functions will also be
measured. The goal of this study is to define the patient
population for any Phase 3 studies that we may conduct in IPF
chronic cough.
- The Company also announced during the quarter the appointment
of Margaret Garin,
MD, MSCR, as Vice President of Clinical Development. Dr. Garin
brings unique and relevant experience from her previous lead role
in clinical development at Bellus Health.
- The Company ended the second quarter of 2024 with $69.5 million in cash, cash equivalents and
marketable securities with expected cash runway into 2026.
Second Quarter 2024 Financial Highlights
Research and development (R&D) expenses: R&D
expenses for the second quarter of 2024 increased to $10.0 million from $5.8
million in the same period in 2023, primarily due to
increased clinical development expenses for our Phase 2b CORAL trial, our Phase 2a RIVER trial, our HAP
study and our recently initiated Phase 1b TIDAL study, as well as increases in personnel
and related expenses and stock-based compensation expense. These
increases were partially offset by decreased clinical development
expenses for our Phase 2b/3 PRISM
trial.
General and administrative (G&A)
expenses: G&A expenses for the second quarter of 2024
increased to $3.3 million from
$2.5 million in the same period in
2023, primarily due to increases in personnel and related expenses,
stock-based compensation expense, market research costs, as well as
information technology services.
Net loss: For the second quarter of 2024, the Company
reported a net loss of $12.4 million,
compared to a net loss of $7.1
million in the same period in 2023.
Conference Call/Webcast
To participate in the live
conference call by phone, please dial (877) 870 4263 (domestic) or
(412) 317 0790 (international) and ask to join the Trevi
Therapeutics call. No code is necessary for access. 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 events:
- August 12-14: Stifel 2024 Biotech
Summer Summit
- September 4-6: 2024 Wells Fargo
Healthcare Conference
- September 7-11: European
Respiratory Society (ERS) Congress 2024
- September 9-11: H.C. Wainwright
26th Annual Global Investment Conference
- September 17-19: 2024 Cantor
Global Healthcare Conference
- September 24-26: 2024 Leerink
Partners Biopharma Summit
About Trevi Therapeutics, Inc.
Trevi Therapeutics, Inc. is a clinical-stage biopharmaceutical
company developing the investigational therapy Haduvio™ (oral
nalbuphine ER) for the treatment of chronic cough in idiopathic
pulmonary fibrosis (IPF) and refractory chronic cough (RCC).
Haduvio is a dual ĸ-opioid receptor agonist and µ-opioid receptor
antagonist that works both centrally in the brain as well as
peripherally in the lungs and has the potential for a synergistic
antitussive effect to treat chronic cough. Parenteral nalbuphine is
not scheduled by the U.S. Drug Enforcement Agency.
The impact of chronic cough is significant and often leads to a
decline in patients' social, physical, and psychological quality of
life. 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. There are no approved therapies for the treatment
of chronic cough in IPF and current treatment options provide
minimal benefit to patients. Chronic cough affects up to 10% of the
adult population, and Haduvio's expansion into RCC has the
potential to reach patients suffering from moderate to severe
refractory chronic cough. There are also no approved therapies for
RCC in the U.S.
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 X (formerly 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
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 later 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,
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 March 31,
2024 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,
2024
|
|
|
December 31,
2023
|
|
Cash and cash
equivalents
|
|
$
|
12,963
|
|
|
$
|
32,397
|
|
Marketable
securities
|
|
|
56,532
|
|
|
|
50,574
|
|
Working
capital
|
|
|
65,377
|
|
|
|
81,723
|
|
Total assets
|
|
|
73,810
|
|
|
|
89,403
|
|
Stockholders'
equity
|
|
|
66,174
|
|
|
|
82,547
|
|
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,
|
|
|
|
2024
|
|
|
2023
|
|
|
2024
|
|
|
2023
|
|
Operating
expenses:
|
|
|
|
|
|
|
|
|
|
|
|
|
Research and
development
|
|
$
|
10,021
|
|
|
$
|
5,842
|
|
|
$
|
18,825
|
|
|
$
|
10,842
|
|
General and
administrative
|
|
|
3,268
|
|
|
|
2,540
|
|
|
|
6,370
|
|
|
|
5,103
|
|
Total operating
expenses
|
|
|
13,289
|
|
|
|
8,382
|
|
|
|
25,195
|
|
|
|
15,945
|
|
Loss from
operations
|
|
|
(13,289)
|
|
|
|
(8,382)
|
|
|
|
(25,195)
|
|
|
|
(15,945)
|
|
Other income,
net
|
|
|
929
|
|
|
|
1,207
|
|
|
|
1,925
|
|
|
|
2,362
|
|
Loss before income
taxes
|
|
|
(12,360)
|
|
|
|
(7,175)
|
|
|
|
(23,270)
|
|
|
|
(13,583)
|
|
Income tax
benefit
|
|
|
8
|
|
|
|
30
|
|
|
|
16
|
|
|
|
37
|
|
Net loss
|
|
$
|
(12,352)
|
|
|
$
|
(7,145)
|
|
|
$
|
(23,254)
|
|
|
$
|
(13,546)
|
|
Basic and diluted net
loss per common share outstanding
|
|
$
|
(0.12)
|
|
|
$
|
(0.07)
|
|
|
$
|
(0.23)
|
|
|
$
|
(0.14)
|
|
Weighted average common
shares used in net loss
per share attributable to common stockholders,
basic and diluted
|
|
|
101,041,573
|
|
|
|
98,698,579
|
|
|
|
100,279,393
|
|
|
|
98,654,868
|
|
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.