Full Press Release Details
Fourth Quarter and Full Year 2021 Results
utilization gaining traction in key target markets
Leader Patricia Drake appointed new Chief Commercial
OLINVYK vs IV morphine in high-risk subjects demonstrates
statistically significant benefit in lowering respiratory depression
OLINVYK ex-US royalty-based financing
with R-Bridge Healthcare Fund
conference call today, March 31st , 2022, at 8:00 a.m. ET
Mar. 31, 2022 (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 fourth quarter and full year ended December 31, 2021, and provided an overview of its 2021 and 2022 year-to-date operational
an important year for Trevena as we launched OLINVYK in the hospital setting. Our sales and marketing team, led by our new CCO Pattie
Drake, adapted to the pandemic headwinds and we are confident the foundation we established positions us well in 2022," said Carrie
Bourdow, President and CEO of Trevena. "We also continued to build upon the supportive profile for OLINVYK with positive topline
respiratory physiology data announced today, and two additional post-approval studies underway. In addition, TRV027 is being studied
in COVID patients by the NIH, with enrollment expanding to international sites, and our novel S1P modulator TRV045 entered clinical studies
to support development for diabetic neuropathic pain. We also solidified our financial position and recognized value for an important
asset through our ex-US royalty-based financing of up to $40 million. We are pleased with the continued progress and look forward to
discussing results in the near future."
YTD Corporate Highlights:
of OLINVYK (oliceridine) injection
Compelling Clinical Support for OLINVYK
November 2021, the Company also announced a new study designed to assess the potential reduced effect of OLINVYK on cognitive function
compared to IV morphine, being conducted in collaboration with the Netherlands-based Center for Human
Drug Research. Cognitive function will be assessed using NeuroCart, a validated
neurocognitive test methodology, and will also include pain model testing. Topline data from this study is expected by mid-2022.
Results for Fourth Quarter and Full Year 2021
Company today reported $66.9 million in cash and cash equivalents as of December 31, 2021, which it believes will be sufficient
to fund operating expenses and capital expenditure requirements through the fourth quarter of 2022. This cash balance does
not include proceeds from the R Bridge Financing, announced today. For the fourth quarter of 2021, the Company reported a net loss attributable
to common stockholders of $14.7 million, or $0.09 per share, compared to $11.9 million, or $0.08 per share, for the fourth quarter of
2020. For the full year ended December 31, 2021, net loss attributable to common stockholders was $52.3 million, or $0.32 per
share, compared to $29.4 million, or $0.23 per share, for the year ended December 31, 2020. This increase is primarily due to activities
around the commercial launch of OLINVYK.
Call and Webcast Information
Company will host a conference call and webcast with the investment community on March 31st, 2022, 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, Senior Vice President and Chief Financial Officer.
| Title: | Trevena Fourth Quarter & Full Year 2021 Financial Results Conference Call and Webcast |
| Date: | Thursday, March 31, 2022 |
| Time: | 8:00 a.m. ET |
| Conference Call Details: | Toll-Free: (855) 465-0180 International: (484) 756-4313 Conference ID: 8874745 |
| Webcast: | https://www.trevena.com/investors/events-presentations/ir-calendar |
(oliceridine) injection
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.
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 four differentiated investigational drug candidates:
TRV250 for the acute treatment of migraine, TRV734 for maintenance treatment of opioid use disorder, TRV045 for diabetic neuropathic
pain and epilepsy, and TRV027 for acute respiratory distress syndrome and abnormal blood clotting in COVID-19 patients.
For more information,
please visit www.Trevena.com
CBC Group is Asia's largest and most active healthcare-dedicated investment
firm with over US$5 billion AUM, focused on platform-building, buyout opportunities, and alternative financing across three core areas:
pharmaceutical & biotech, medtech, and healthcare services. CBC has a leading team of investment, industry and portfolio management
professionals, headquartered in Singapore with offices in New York, Shanghai, Beijing, and Hong Kong and presence in Boston, San Diego,
San Francisco and Tokyo.
Founded in February 2020, R-Bridge
Healthcare Fund is an affiliate of CBC Group and it is dedicated in providing alternative, non-dilutive financing backed by royalties,
revenue interest and other cash flows generated by the sale of healthcare products and services in China, the first of its kind for the
asset class and the region. R-Bridge provides additional sources of capital to leading healthcare companies to continue their extraordinary
growth trajectories, commercializing their products and services in China and on a global scale.