Full Press Release Details
Trevena Reports First Quarter 2023 Results and
Provides Business Update
OLINVYK receives regulatory
approval in China, triggering $3 million milestone payment from Company's China partner Jiangsu Nhwa Pharmaceutical
Company expects to receive additional $15 million
non-dilutive tranche from R-Bridge upon first commercial sale of OLINVYK in China
TRV045 topline data expected in 3Q 2023 for
two proof-of-concept studies supporting continued development for potential use in epilepsy and chronic pain
announced initial topline OLINVYK data demonstrated a statistically significant 1.6-day (~27%) reduction in average overall hospital length
of stay compared to matched patients treated with other IV opioids, based on initial EMR analysis of patients at Wake Forest Baptist Health
Company continues to expect new OLINVYK respiratory
data and additional health utilization and cost analyses from ~200 patient real-world clinical outcomes study in mid-2023
to host conference call today, May 15, 2023 at 8:00 a.m. ET
CHESTERBROOK, Pa., May 15, 2023 (GLOBE NEWSWIRE) -Trevena, Inc.
(Nasdaq: TRVN), a biopharmaceutical company focused on the development and commercialization of novel medicines for patients with central
nervous system (CNS) disorders, today reported its financial results for the first quarter ended March 31, 2023, and provided an
overview of its recent operational highlights.
"This is an important year for Trevena as we expect topline data
from two TRV045 proof-of-concept studies, one to support potential use in epilepsy and the other in chronic pain, and new OLINVYK respiratory
data from the VOLITION study with Cleveland Clinic," said Carrie Bourdow, President and CEO of Trevena. "We were also pleased
that Jiangsu Nhwa recently received approval of OLINVYK in China which will allow patients there to have access to this innovative therapeutic
First Quarter 2023 and Recent Corporate Highlights
Financial Results for First Quarter 2023
For the first quarter of 2023, the Company reported a net loss attributable
to common stockholders of $7.8 million, or $0.81 per share, compared to $16.4 million, or $2.48 per share in the first quarter of 2022.
Cash, cash equivalents and marketable securities were $27.4 million
as of March 31, 2023, which the Company believes will be sufficient to fund the Company's operations through year-end 2023.
Together with the expected $3 million Nhwa Milestone payment and $15 million available under the R-Bridge Financing upon Nhwa's
first commercial sale of OLINVYK in China, the Company believes this will be sufficient to fund operations to mid-2024.
Conference Call and Webcast Information
The Company will host a conference call and webcast with the investment
community on May 15, 2023, at 8:00 a.m. Eastern Time featuring remarks by Carrie Bourdow, President and Chief Executive Officer,
Patricia Drake, Chief Commercial Officer, Mark Demitrack, M.D., Senior Vice President and Chief Medical Officer, and Barry Shin, Chief
| Title: | Trevena First Quarter 2023 Financial Results Conference Call & Webcast |
| Date: | Monday, May 15, 2023 |
| Time: | 8:00 a.m. ET |
| Conference Call Details: | Toll-Free: 1-844-825-9789 International: 1-412-317-5180 Conference ID: 10178141 |
The conference call will be webcast live from the Company's website and will be available via the following links:
The webcast should be accessed 15 minutes prior to the conference
call start time. A replay of the webcast will be available following the conclusion of the live broadcast and will be accessible on the
OLINVYK (oliceridine) injection
OLINVYK is a new chemical entity approved by the
FDA in August 2020. OLINVYK contains oliceridine, an opioid, which is a Schedule II controlled substance with a high potential for
abuse similar to other opioids. It is indicated in adults for the management of acute pain severe enough to require an intravenous opioid
analgesic and for whom alternative treatments are inadequate. OLINVYK is available in 1 mg/1 mL and 2 mg/2 mL single-dose vials, and a
30 mg/30 mL single-patient-use vial for patient-controlled analgesia (PCA). Approved PCA doses are 0.35 mg and 0.5 mg and doses greater
than 3 mg should not be administered. The cumulative daily dose should not exceed 27 mg. Please see Important Safety Information, including
the BOXED WARNING, and full prescribing information at www.OLINVYK.com.
ABUSE, AND MISUSE; LIFE-THREATENING RESPIRATORY DEPRESSION; NEONATAL OPIOID WITHDRAWAL SYNDROME; and RISKS FROM CONCOMITANT USE WITH BENZODIAZEPINES
OR OTHER CENTRAL NERVOUS SYSTEM (CNS) DEPRESSANTS
ABUSE, AND MISUSE - OLINVYK exposes patients and other users to the risks of opioid addiction, abuse, and misuse, which
can lead to overdose and death. Assess each patient's risk before prescribing OLINVYK, and monitor all patients regularly for the
development of behaviors or conditions.
RESPIRATORY DEPRESSION - Serious, life-threatening, or fatal respiratory depression may occur with use of OLINVYK. Monitor
for respiratory depression, especially during initiation of OLINVYK or following a dose increase.
OPIOID WITHDRAWAL SYNDROME - Prolonged use of OLINVYK during pregnancy can result in neonatal opioid withdrawal syndrome,
which may be life-threatening if not recognized and treated, and requires management according to protocols developed by neonatology experts.
If opioid use is required for a prolonged period in a pregnant woman, advise the patient of the risk of neonatal opioid withdrawal syndrome
and ensure that appropriate treatment will be available.
FROM CONCOMITANT USE WITH BENZODIAZEPINES OR OTHER CNS DEPRESSANTS - Concomitant use of opioids with benzodiazepines
or other CNS depressants, including alcohol, may result in profound sedation, respiratory depression, coma, and death. Reserve concomitant
prescribing for use in patients for whom alternative treatment options are inadequate; limit dosages and durations to the minimum required;
and follow patients for signs and symptoms of respiratory depression and sedation.
INDICATIONS AND USAGE
OLINVYK is an opioid agonist indicated in adults for the management
of acute pain severe enough to require an intravenous opioid analgesic and for whom alternative treatments are inadequate.
Because of the risks of addiction, abuse, and misuse with opioids,
even at recommended doses, reserve OLINVYK for use in patients for whom alternative treatment options [e.g., non-opioid analgesics or
opioid combination products]:
The cumulative total daily dose should not exceed 27 mg, as total
daily doses greater than 27 mg may increase the risk for QTc interval prolongation.
OLINVYK is contraindicated in patients with:
WARNINGS AND PRECAUTIONS
Adverse reactions are described in greater detail in the Prescribing
The most common (incidence 10%) adverse reactions in Phase 3 controlled
clinical trials were nausea, vomiting, dizziness, headache, constipation, pruritus, and hypoxia.
medical inquiries or to report an adverse event, other safety-related information or product complaints for a company product, please
contact the Trevena Medical Information Contact Center at 1-844-465-4686 or email MedInfo@Trevena.com.
are encouraged to report suspected adverse events of prescription drugs to the FDA. Visit www.fda.gov/medwatch or
call 1-800-FDA-1088.
Please see Full Prescribing Information, including Boxed Warning.
TRV045 is a novel, selective sphingosine-1-phosphate
subtype 1 (S1P1) receptor modulator being developed as a potential treatment for acute and chronic neuropathic pain secondary
to diabetic peripheral neuropathy. Through a collaboration with the National Institutes of Health, Trevena is also exploring TRV045 as
a potential treatment for epilepsy.
S1P receptors are located throughout the body,
including the central nervous system, where they are believed to play a role in modulating neurotransmission and membrane excitability.
Trevena's discovery efforts have identified a
family of compounds that are highly selective for the S1P1 receptor. TRV045 reversed thermal hyperalgesia, a measure of neuropathic
pain, in nonclinical models of diabetic peripheral neuropathy and chemotherapy-induced peripheral neuropathy. TRV045 was not associated
with lymphopenia and produced no changes in blood pressure, heart rate, or respiratory function at or above pharmacologically active doses
in nonclinical studies. TRV045 is an investigational product and is not yet approved by the FDA.
Trevena, Inc. is a biopharmaceutical company focused on the development
and commercialization of innovative medicines for patients with CNS disorders. The Company has one approved product in the United States,
OLINVYK (oliceridine) injection, indicated in adults for the management of acute pain severe enough to require an
intravenous opioid analgesic and for whom alternative treatments are inadequate. The Company's novel pipeline is based on Nobel
Prize winning research and includes three differentiated investigational drug candidates: TRV045 for diabetic neuropathic pain and epilepsy,
TRV250 for the acute treatment of migraine and TRV734 for maintenance treatment of opioid use disorder.
For more information, please visit www.Trevena.com
Jiangsu Nhwa Pharmaceutical Co., Ltd.
(SZ002262), founded in 1978, is a leading CNS company in China. Over the past 40 years, Nhwa is exclusively dedicated to developing innovative
and differentiated pipeline in the areas of anesthesia, analgesia, psychiatry and neurology via in-house R&D and global partnership.
As a fully integrated pharmaceutical