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Trevena Reports First Quarter 2022 Results and Provides Business Update OLINVYK refocused commercial strategy initiated mid-Q1 OLINVYK respiratory physiology study demonstrated statistically significant reduced impact on

Key Takeaway: First Quarter 2022 Results and Provides commercial strategy initiated mid-Q1 physiology study demonstrated statistically significant reduced impact on respiratory function compared to IV morphine, among elderly/overweight study for OLINVYK versus IV morphine on track for topli

Full Press Release Details

First Quarter 2022 Results and Provides
commercial strategy initiated mid-Q1
physiology study demonstrated statistically significant reduced impact on respiratory function compared to IV morphine, among elderly/overweight
study for OLINVYK versus IV morphine on track for topline results mid-year
of Phase I study for TRV045, novel S1P receptor modulator, for use in diabetic neuropathic pain (DNP); NIH preclinical studies in epilepsy
financing with R-Bridge Healthcare Fund;
$15 million tranche in April 2022
conference call today, May 11th, 2022 at 8:00 a.m. ET
May 11, 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 first quarter ended March 31, 2022 and provided an overview of its recent operational highlights.
quarter, we began to see hospitals opening up post the pandemic as evidenced by accelerated field execution of the OLINVYK strategy and
an increase in educational programs and training," said Carrie Bourdow, President and CEO of Trevena. "We also remained focused
on advancing the clinical studies for OLINVYK and TRV045, our novel S1P receptor modulator and we strengthened our balance sheet following
receipt of the initial $15 million tranche of our ex-US royalty-based financing".
First Quarter 2022 and Recent Corporate
OLINVYK (oliceridine) injection Milestones
Financial Results for First Quarter
For the first quarter
of 2022, the Company reported a net loss attributable to common stockholders of $16.4 million, or $0.10 per share, compared to $9.8 million,
or $0.06 per share, for the first quarter of 2021.
Cash and cash equivalents
were $48.7 million as of March 31, 2022, which the Company believes will be sufficient to fund the Company's operating expenses
and capital expenditure requirements into 2023. This cash balance does not include proceeds from the receipt in April of the first
$15 million tranche from the royalty-based financing agreement with an affiliate of R Bridge Healthcare Fund.
In addition, the Company announced its
Annual General Meeting will be held on June 9th, 2022. In the definitive proxy statements, the Company is requesting
approval for additional authorized shares. The proposal would result in no immediate dilution for stockholders. The increase in authorized
shares is intended to provide flexibility to execute on the Company's business development opportunities, achieve the $10M tranche
from our R-Bridge financing, and advance the Company's products and pipeline.
Conference Call and Webcast Information
Company will host a conference call and webcast with the investment community on May 11th, 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 First Quarter 2022 Financial Results Conference Call & Webcast
Date: Wednesday, May 11, 2022
Time: 8:00 a.m. ET
Conference Call Details: Toll-Free: 1-844-826-3033 International: 1-412-317-5185 Conference ID: 10166614
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=1545824&tp_key=fa08098dd7
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: TRV045 for
diabetic neuropathic pain and epilepsy, TRV027 for acute respiratory distress syndrome and abnormal blood clotting in COVID-19 patients,
TRV250 for the acute treatment of migraine and TRV734 for maintenance treatment of opioid use disorder.
(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.
Prescribing Information, including Boxed Warning.
For more information,
please visit www.Trevena.com
is a common complication of both type 1 and type 2 diabetes, with pain in the extremities being one of the main symptoms. Other symptoms
may include numbness, tingling, allodynia and hyperalgesia. Diabetic neuropathic pain is usually characterized as moderate to severe
in nature and can substantially affect patients' quality of life as well as their social and psychological well-being.
of people with diabetes are affected by DNP, equaling over 5 million people in the U.S. During their lifetime, approximately 50%
to 70% of diabetic patients may experience symptoms of DNP.
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.
Last updated: May 11, 2022