Full Press Release Details
Second Quarter 2023 Results and Provides Business Update
database lock for TRV045 proof-of-concept TMS study evaluating potential for use in epilepsy; topline data expected 3Q 2023
TRV045 proof-of-concept
study evaluating potential for use in acute and chronic pain advancing with topline data expected 3Q 2023
data from VOLITION ~200 patient real-world outcomes study, using continuous respiratory monitoring, expected 3Q 2023
announced results of ARTEMIS study in which OLINVYK-treated patients had a statistically significant ~$8,750 (19%) lower cost per admission
and ~1.4 day (20%) reduced average length of hospital stay, compared to matched patients treated with other IV opioids
announced $3 million milestone payment from Jiangsu Nhwa Pharmaceutical; anticipates receipt of additional $15 million non-dilutive tranche
from R-Bridge 3Q 2023
CHESTERBROOK, Pa., August 14, 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 second quarter ended
June 30, 2023 and provided an overview of its recent operational highlights.
"This is an exciting time for
Trevena as we near completion of proof-of-concept studies evaluating the potential for use of TRV045 in both epilepsy and pain,"
said Carrie Bourdow, President and CEO of Trevena. "We anticipate achieving a range of other milestones in Q3, including new respiratory
data for OLINVYK and receipt of a non-dilutive $15 million tranche from our ex-US royalty based financing. We look forward to updating
you as these developments occur."
Second Quarter 2023 and Recent Corporate
The Company expects to announce
data from each study in 3Q 2023. Subjects were enrolled at study sites outside of the United States and the studies are not being conducted
under the Investigational New Drug Application (IND) for TRV045.
Financial Results for Second Quarter
For the second quarter of 2023, the
Company reported net revenue of $3.0 million, and a net loss attributable to common stockholders of $8.0 million, or $0.69 per share,
compared to $15.0 million, or $2.26 per share in the second quarter of 2022.
Cash and cash equivalents were $28.1
million as of June 30, 2023, which the Company believes will be sufficient to fund the Company's operating expenses and capital
expenditure requirements into 2024. This cash balance does not include a $15 million non-dilutive tranche from the R-Bridge Financing
that the Company anticipates receiving in the third quarter of 2023.
About OLINVYK (oliceridine)
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.
ADDICTION, 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
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
WARNINGS AND PRECAUTIONS
Adverse reactions are described in greater
detail in the Prescribing Information.
The most common (incidence 10%)
adverse reactions in Phase 3 controlled clinical trials were nausea, vomiting, dizziness, headache, constipation, pruritus, and hypoxia.
For 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.
You 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.
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.
located throughout the body, including the central nervous system, where they are believed to play a role in modulating neurotransmission
and membrane excitability.
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
For more information, please visit www.Trevena.com
in this press release about future expectations, plans and prospects for the Company, including statements about the Company's
strategy, future operations, clinical development and trials of its therapeutic candidates, plans for potential future product candidates
and other statements containing the words "anticipate," "believe," "estimate," "expect,"
"intend," "may," "plan," "predict," "project," "suggest," "target,"
"potential," "will," "would," "could," "should," "continue,"
and similar expressions, constitute forward-looking statements within the meaning of The Private Securities Litigation Reform Act of
1995. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors,
including: the status, timing, costs, results and interpretation of the Company's clinical trials or any future trials of any of
the Company's investigational drug candidates; the uncertainties inherent in conducting clinical trials; expectations for regulatory
interactions, submissions and approvals, including the Company's assessment of discussions with FDA; available funding; uncertainties
related to the Company's intellectual property; other matters that could affect the availability or commercial potential of the