Management to host a conference call and
webcast today at 4:30 p.m.
EDT
NEW
HAVEN, Conn., Nov. 10,
2022 /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 adults with
idiopathic pulmonary fibrosis (IPF) and other chronic cough
indications, and for the treatment of prurigo nodularis, today
announced financial results for the quarter ended
September 30, 2022, as well as provided business updates.
"I am incredibly proud of the progress our team has made this
year with two positive data read-outs in our indications and
subsequent successful financings," said Jennifer Good, President and CEO of Trevi
Therapeutics. "At our R&D Day in September, we announced the
final positive results from our Phase 2 CANAL trial of Haduvio for
the treatment of chronic cough in IPF that demonstrated a strong
magnitude of effect on cough and statistically significant data for
the primary efficacy endpoint and other key secondary endpoints. We
have approximately $126 million in
cash, cash equivalents, and investments at the end of the quarter,
which we plan to use to fund further development in our targeted
cough indications."
Key Business Updates
Phase 2 CANAL trial of Haduvio for the treatment of chronic
cough in IPF
As previously announced, the Phase 2 CANAL
trial results from the full analysis set (N=38) achieved
statistical significance on the trial's primary endpoint and showed
Haduvio subjects had a 75.1% reduction in daytime cough frequency
at the end of the treatment period vs. study baseline, compared to
placebo subjects who had a 22.6% reduction, a 52.5%
placebo-adjusted change (p<0.0001). The primary endpoint was
supported by key secondary patient and clinician-reported outcomes.
The safety results of the trial were generally consistent with the
known safety profile of nalbuphine ER from previous trials. IPF is
a serious, end-of-life disease, and chronic cough is a major cause
of morbidity, significantly impacting these patients' quality of
life.
Phase 2b/3 PRISM trial of
Haduvio
We are continuing the open-label extension portion
of our Phase 2b/3 PRISM trial for the
treatment of prurigo nodularis, which we expect to complete in the
first quarter of 2023. We plan to request an end of phase 2
meeting with the U.S. Food and Drug Administration in the first
quarter of 2023.
Third Quarter 2022 Financial Highlights
Research and development (R&D) expenses: R&D
expenses for the third quarter of 2022 were $5.8 million compared to $4.7 million in the same period in 2021. The
increase was primarily due to startup activities for our planned
trials including purchases of clinical trial supplies and increased
costs associated with increased activity in our Phase 2 CANAL trial
as compared to the third quarter of 2021. This was offset by a
reduction in costs associated with decreased activity in our Phase
2b/3 PRISM trial due to the
completion of the blinded portion of the trial in the second
quarter of 2022.
General and administrative (G&A) expenses: G&A
expenses were $2.6 million in the
third quarter of 2022 compared to $2.2
million in the same period in 2021. The increase was
primarily due to higher legal fees associated with intellectual
property filings and increased market research costs.
Net loss: For the third quarter of 2022, the Company
reported a net loss of $8.3 million,
compared to a net loss of $7.3
million in the same period in 2021. The increase was
primarily due to the increase in R&D expenses.
Conference Call/Webcast
To participate in the live
conference call by phone, please dial (888) 317 6003 (domestic) or
(412) 317 6061 (international) and provide access code 4950734. 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 at
the following upcoming conferences and events:
- November 16: Stifel 2022
Healthcare Conference
- November 23: British Thoracic
Society Winter Meeting 2022
About Chronic Cough in Idiopathic Pulmonary
Fibrosis
IPF is a serious, end-of-life disease, and chronic
cough is a major cause of morbidity, significantly impacting these
patients' quality of life. There are estimated to be 140,000 IPF
patients in the US and more than 1 million patients outside the US.
Up to 85% of IPF patients experience chronic cough. There are no
approved therapies for the treatment of chronic cough in IPF and
the cough often isn't affected by antitussive therapy. Patients
with chronic cough in IPF can cough up to 1,500 times per day,
leading to increased feelings of fear and stress as it causes
shortness of breath. Coughing spells or episodes lead to
significant fatigue, an urge to breathe, low levels of oxygen in
the blood, and some patients also experience loss of bladder
control. The social impact of chronic cough in IPF is increased
because of limited exercise ability, reduced walking distance, and
the need for additional oxygen. Chronic cough in IPF may be an
early clinical marker of disease activity that could potentially
help to identify patients at high risk of progression and predict
time to death or lung transplant. In addition, chronic cough in IPF
may also contribute to enhanced activation of profibrotic
mechanisms and disease worsening.
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 adults with
idiopathic pulmonary fibrosis (IPF) and other chronic cough
indications, and for the treatment of prurigo nodularis. The
Company has successfully completed a Phase 2 trial of Haduvio for
the treatment of chronic cough in adults with idiopathic pulmonary
fibrosis (IPF). Based on this positive data, Trevi plans to focus
future clinical development on chronic cough conditions, including
IPF, refractory chronic cough, and interstitial lung diseases
(ILDs).
For more information, visit www.TreviTherapeutics.comand follow
the Company on Twitter and LinkedIn.
About Haduvio
Haduvio, an investigational therapy, is an oral extended-release
(ER) 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 centrally and peripherally active
and known to be critical mediators of cough and itch. Nalbuphine's
mechanism of action may also mitigate the risk of abuse associated
with µ-opioid agonists because it antagonizes, or blocks, µ-opioid
receptors. Parenteral nalbuphine is not currently scheduled as a
controlled substance by the DEA in the United States or
by regulatory authorities in most
of Europe. Trevi intends to propose Haduvio as the
trade name for nalbuphine ER. Its safety and efficacy have not been
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 Trevi's
business plans and objectives, including future plans or
expectations for Haduvio and plans 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 Trevi's 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; 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 September 30, 2022 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, 2022
|
|
|
December 31, 2021
|
|
Cash and cash
equivalents
|
|
$
|
66,574
|
|
|
$
|
36,830
|
|
Marketable
securities
|
|
|
59,029
|
|
|
|
—
|
|
Working
capital
|
|
|
112,677
|
|
|
|
25,233
|
|
Total assets
|
|
|
128,361
|
|
|
|
38,475
|
|
Total debt
|
|
|
10,800
|
|
|
|
14,485
|
|
Stockholders'
equity
|
|
|
109,903
|
|
|
|
17,075
|
|
Trevi Therapeutics,
Inc. Selected Statement of Operations Data
(unaudited) (amounts in thousands, except per share
amounts)
|
|
|
|
Three Months
Ended September 30,
|
|
|
Nine Months
Ended September 30,
|
|
|
|
2022
|
|
|
2021
|
|
|
2022
|
|
|
2021
|
|
Operating
expenses:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Research and
development
|
|
$
|
5,769
|
|
|
$
|
4,718
|
|
|
$
|
15,517
|
|
|
$
|
16,805
|
|
General and
administrative
|
|
|
2,636
|
|
|
|
2,229
|
|
|
|
7,733
|
|
|
|
7,398
|
|
Total operating
expenses
|
|
|
8,405
|
|
|
|
6,947
|
|
|
|
23,250
|
|
|
|
24,203
|
|
Loss from
operations
|
|
|
(8,405)
|
|
|
|
(6,947)
|
|
|
|
(23,250)
|
|
|
|
(24,203)
|
|
Other income
(expense), net
|
|
|
132
|
|
|
|
(306)
|
|
|
|
(413)
|
|
|
|
(1,232)
|
|
Loss before income
taxes
|
|
|
(8,273)
|
|
|
|
(7,253)
|
|
|
|
(23,663)
|
|
|
|
(25,435)
|
|
Income tax benefit
(expense)
|
|
|
7
|
|
|
|
(2)
|
|
|
|
16
|
|
|
|
15
|
|
Net loss
|
|
$
|
(8,266)
|
|
|
$
|
(7,255)
|
|
|
$
|
(23,647)
|
|
|
$
|
(25,420)
|
|
Basic and diluted net
loss per common share
outstanding
|
|
$
|
(0.12)
|
|
|
$
|
(0.34)
|
|
|
$
|
(0.44)
|
|
|
$
|
(1.25)
|
|
Weighted average common
shares used in net
loss per
share attributable to common
stockholders, basic and diluted
|
|
|
68,898,810
|
|
|
|
21,607,979
|
|
|
|
53,221,949
|
|
|
|
20,390,852
|
|
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.