Multiple trial initiations planned for 2023 to
progress Haduvio in chronic cough indications
Management to host a conference call and
webcast today at 4:30 p.m.
EDT
NEW
HAVEN, Conn., March 16,
2023 /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 and year ended
December 31, 2022, as well as provided business updates.
Trevi has multiple trial initiations
planned for 2023 to progress Haduvio in chronic cough
indications
"Following the very encouraging results from our Phase 2 CANAL
trial in IPF chronic cough, we have entered a transformational
period in the development of Haduvio for the treatment of serious
chronic cough conditions," said Jennifer
Good, President and CEO of Trevi Therapeutics. "With a
strong balance sheet and cash runway expected into 2026, we are
well-positioned to develop Haduvio as a pipeline in a product,
supported by the differentiated central and peripheral mechanism of
action of Haduvio."
2022 Fourth Quarter and Year End Business Highlights
- Presented final data from the Phase 2 CANAL Trial of Haduvio
for the treatment of chronic cough in IPF at the British Thoracic
Society's Winter Meeting.
- Appointed David Clark, MD, MRCP,
as Chief Medical Officer.
- Initiated the Human Abuse Liability study for Haduvio.
- Ended 2022 with cash, cash equivalents, and marketable
securities of $120.5 million.
Key Business Updates
IPF Chronic Cough Clinical Trials
The Company is
planning to conduct a Phase 2b dose
ranging trial of Haduvio for the treatment of chronic cough in
IPF patients. The objective of the trial is to determine the
dose response of Haduvio in this IPF patient population. The
Company expects to initiate this dose ranging study in the second
half of 2023.
The Company is also planning a Phase 1b study to evaluate the effect of Haduvio on
respiratory physiology in IPF patients of varying disease severity.
The Company is in discussions with the U.S. Food and Drug
Administration (FDA) regarding the design of this trial and expects
to start this trial in the second half of 2023.
Phase 2a Trial in Refractory Chronic Cough
The Company
is preparing to conduct a Phase 2a study in refractory chronic
cough which is expected to be initiated in the third quarter of
2023. The objective of this trial is to establish the potential of
Haduvio across a broader range of chronic cough conditions and to
further validate the importance of Haduvio's central and peripheral
mechanism of action in a variety of chronic cough patient
populations.
Phase 2b/3 PRISM Trial
in Prurigo Nodularis
Dosing was completed in the open-label extension portion of our
Phase 2b/3 PRISM trial for the
treatment of prurigo nodularis in the first quarter of 2023 and
full data are expected in the second quarter of 2023. Once data is
received, the Company intends to request an end of phase 2
meeting with the FDA. The Company also plans to present the data
from the open-label extension at a future medical meeting.
Human Abuse Liability Study
The Company initiated a
human abuse liability study in the fourth quarter of 2022 to
compare the abuse potential of oral nalbuphine to butorphanol. The
injectable version of nalbuphine is currently unscheduled in the
U.S. by the Drug Enforcement Agency (DEA). The study is a
randomized, double-blind, active and placebo-controlled 5-way
crossover design. The study is conducted in two parts, with the
first part characterizing various butorphanol doses. One
butorphanol dose will be selected to be studied in the second part
of the protocol to determine the abuse potential of oral nalbuphine
relative to butorphanol. The Company is currently completing Part 1
of the study and expects top-line data from the complete trial by
the end of 2023.
Fourth Quarter 2022 Financial Highlights
Research and development (R&D) expenses: R&D
expenses for the fourth quarter of 2022 decreased to $4.3 million from $6.2
million in the same period in 2021. The decrease was
primarily due to decreased clinical trial costs reflecting the
completion prior to the fourth quarter of 2022 of both the blinded
portion of the Phase 2b/3 PRISM trial
and the Phase 2 CANAL trial, partially offset by an increase in
trial costs related to the human abuse liability study.
General and administrative (G&A) expenses: G&A
expenses were $2.3 million in the
fourth quarter of 2022 compared to $2.1
million in the same period in 2021. The increase was
primarily due to higher legal fees associated with intellectual
property filings and other professional fees.
Other income (expense), net: Other income, net was
$1.1 million in the fourth quarter of
2022 compared to other expense, net of $0.3
million in the same period in 2021. The change was primarily
due to an increase in interest income.
Net loss: For the fourth quarter of 2022, the Company
reported a net loss of $5.5 million,
compared to a net loss of $8.5
million in the same period in 2021.
Full-Year 2022 Financial Highlights
R&D expenses: R&D expenses for the year ended
December 31, 2022, were $19.8 million compared to $23.0 for the year ended December 31, 2021. The decrease was primarily due
to decreased trial costs reflecting the completion of the blinded
portion of the Phase 2b/3 PRISM trial
and the Phase 2 CANAL trial in 2022, which were partially offset by
an increase in startup activities for our planned trials including
purchases of clinical trial supplies and increased consulting
expenses and professional fees.
G&A expenses: G&A expenses for the year ended
December 31, 2022, were $10.1 million compared to $9.5 million for the year ended December 31, 2021. The increase was primarily due
to increased market research costs and professional fees.
Other income (expense), net: Other income, net for the
year ended December 31, 2022, was
$0.7 million compared to other
expense, net of $1.5 million for the
year ended December 31, 2021. The
change was primarily due to an increase in interest income due to
higher cash equivalent and marketable securities balances invested
at higher interest rate yields and a decrease in expense related to
the value of shares of common stock issued as a commitment fee
under an equity credit facility which did not recur in 2022.
Net loss: For the year ended December 31, 2022, the Company reported a net
loss of $29.2 million, compared to a
net loss of $33.9 million for the
year ended December 31, 2021.
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 1366506. 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:
- March 20-22: BIO-Europe
Spring
- April 17-20: 22nd
Annual Needham Virtual Healthcare Conference
About Trevi Therapeutics, Inc.
Trevi Therapeutics, Inc. is a clinical-stage biopharmaceutical
company developing Haduvio, an investigational therapy in an oral
extended-release formulation of nalbuphine, for the treatment of
chronic cough in IPF and other chronic cough indications. Haduvio
is a mixed ĸ-opioid receptor agonist and µ-opioid receptor
antagonist that works both centrally and peripherally. The ĸ and µ
receptors are known critical mediators of cough. Parenteral
nalbuphine has been approved and marketed for over 20 years for the
treatment of acute pain indications and is not scheduled 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.
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 Trevi's Haduvio in
the United States and foreign
countries, including the Company's ability to submit and get
clearance on an IND 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 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)
|
|
|
|
|
|
December 31,
2022
|
|
|
December 31,
2021
|
|
Cash and cash
equivalents
|
|
$
|
12,589
|
|
|
$
|
36,830
|
|
Marketable
securities
|
|
|
107,921
|
|
|
|
—
|
|
Working
capital
|
|
|
109,216
|
|
|
|
25,233
|
|
Total assets
|
|
|
123,015
|
|
|
|
38,475
|
|
Total debt
|
|
|
9,151
|
|
|
|
14,485
|
|
Stockholders'
equity
|
|
|
107,459
|
|
|
|
17,075
|
|
Trevi Therapeutics,
Inc.
|
|
Selected Statement
of Operations Data
|
|
(unaudited)
|
|
(amounts in
thousands, except per share amounts)
|
|
|
|
|
|
Three Months
Ended
December 31,
|
|
|
Year Ended
December 31,
|
|
|
|
2022
|
|
|
2021
|
|
|
2022
|
|
|
2021
|
|
Operating
expenses:
|
|
|
|
|
|
|
|
|
|
|
|
|
Research and
development
|
|
$
|
4,317
|
|
|
$
|
6,178
|
|
|
$
|
19,834
|
|
|
$
|
22,984
|
|
General and
administrative
|
|
|
2,339
|
|
|
|
2,094
|
|
|
|
10,073
|
|
|
|
9,492
|
|
Total operating
expenses
|
|
|
6,656
|
|
|
|
8,272
|
|
|
|
29,907
|
|
|
|
32,476
|
|
Loss from
operations
|
|
|
(6,656)
|
|
|
|
(8,272)
|
|
|
|
(29,907)
|
|
|
|
(32,476)
|
|
Other income
(expense), net
|
|
|
1,132
|
|
|
|
(254)
|
|
|
|
719
|
|
|
|
(1,485)
|
|
Loss before income
taxes
|
|
|
(5,524)
|
|
|
|
(8,526)
|
|
|
|
(29,188)
|
|
|
|
(33,961)
|
|
Income tax
benefit
|
|
|
20
|
|
|
|
5
|
|
|
|
36
|
|
|
|
21
|
|
Net loss
|
|
$
|
(5,504)
|
|
|
$
|
(8,521)
|
|
|
$
|
(29,152)
|
|
|
$
|
(33,940)
|
|
Basic and diluted net
loss per common share
outstanding
|
|
$
|
(0.06)
|
|
|
$
|
(0.28)
|
|
|
$
|
(0.45)
|
|
|
$
|
(1.49)
|
|
Weighted average common
shares used in net
loss per share attributable to common
stockholders, basic and diluted
|
|
|
98,132,668
|
|
|
|
30,113,457
|
|
|
|
64,541,911
|
|
|
|
22,841,481
|
|
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.