Full Press Release Details
Third Quarter 2023 Results and Provides Business Update
announced statistically significant topline TRV045 data from two proof-of-concept studies evaluating S1PR mechanism of action and CNS
favorable safety and tolerability data from TRV045 POC studies
for OLINVYK presented at American Society of Anesthesiologists (ASA) Conference
from ex-US royalty-based financing agreement received in September
conference call today, November 14, 2023 at 8:00 a.m. ET
CHESTERBROOK, Pa., November 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 third quarter
ended September 30, 2023 and provided an overview of its recent operational highlights.
"The third quarter was exciting
for Trevena as we reported promising proof-of-concept data for our two TRV045 studies, including favorable safety and tolerability topline
data, and strengthened our balance sheet with the receipt of the $15 million dollar R-Bridge tranche," said Carrie Bourdow, President
and CEO of Trevena. "There is a significant need for safe and effective non-opioid therapies in pain, and for novel mechanisms
for the treatment of epilepsy. By the end of the year we anticipate receipt of topline data for TRV045 from the NIH nonclinical seizure
prevention study, and we look forward to updating you on the next steps of our plan to advance TRV045, on our own or with a strategic
partner, for potential treatment of neuropathic pain, epilepsy and other CNS disorders."
Third Quarter 2023 and Recent Corporate
In these studies, TRV045 showed
an overall favorable safety and tolerability profile with no drug-related adverse events, no serious adverse events and no study drug-related
discontinuations reported. The Company is encouraged by the totality of the data from the POC studies and expects to be in a position
in the near future to announce next steps in the clinical development program for TRV045.
in both studies were enrolled outside of the United States, and the studies were not conducted under the Investigational New Drug Application
Financial Results for Third Quarter
For the third quarter of 2023, the Company
reported a net loss attributable to common stockholders of $7.9 million, or $0.57 per share, compared to $15.3 million, or $2.24 per
share in the third quarter of 2022.
Cash and cash equivalents were $35.0
million as of September 30, 2023, which the Company believes will be sufficient to fund the Company's operating expenses and
capital expenditure requirements into the third quarter of 2024.
Conference Call and Webcast Information
host a conference call and webcast with the investment community on November 14, 2023, at 8:00 a.m. Eastern Time featuring
remarks by Carrie Bourdow, President and Chief Executive Officer, Patricia Drake, Chief Commercial Officer, Pattie Drake, Senior Vice
President and Chief Commercial Officer, Mark Demitrack, M.D., Senior Vice President and Chief Medical Officer, and Barry Shin, Chief
Financial Officer. In addition, Dan Clauw, M.D., Professor of Anesthesiology, Medicine (Rheumatology) and Psychiatry at the University
of Michigan and Director of the Chronic Pain and Fatigue Research Center will join the call as well.
| Title: | Trevena Third Quarter 2023 Financial Results Conference Call & Webcast |
| Date: | Tuesday, November 14, 2023 |
| Time: | 8:00 a.m. ET |
| Conference Call Details: | Toll-Free: 1-877-704-4453 International: 1-201-389-0920 Conference ID: 13741466 |
| The conference call will be webcast live from the Company's website and will be available via the following links: | |
| Webcast: https://viavid.webcasts.com/starthere.jsp?ei=1636100&tp_key=5e8700c550 |
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 Company's website.
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
Pharmaceutical Co., Ltd. (SZ002262), founded in 1978, is a leading CNS company in China. Over the past 40 years, Nhwa is exclusively