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Trevena Reports Second Quarter 2022 Results and Provides Business Update OLINVYK post-approval strategy advances with positive topline cognitive function data and continued enrollment in VOLITION clinical outcomes study

Key Takeaway: Trevena Reports Second Quarter 2022 Results and Provides Business Update OLINVYK post-approval strategy advances with positive topline cognitive function data and continued enrollment in VOLITION clinical outcomes study Phase 1 study for TRV045, a novel S1P receptor modulat

Full Press Release Details

Trevena Reports Second Quarter 2022 Results
and Provides Business Update
OLINVYK post-approval strategy advances with
positive topline cognitive function data and continued
enrollment in VOLITION clinical outcomes study
Phase 1 study for TRV045, a novel S1P receptor
modulator, on track for year-end data readout; single
ascending dose and food effect study segments fully enrolled
TRV045 demonstrated potential antiepileptic
effect in multiple preclinical models
Cash balance of $49.5 million at Q2 provides
cash runway to mid-2023 with previously announced
strategic allocation of resources and cost reductions
Company to host conference call today, August
11, 2022 at 8:00 a.m. ET
CHESTERBROOK, Pa., August 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 second quarter ended June 30, 2022 and provided an
overview of its recent operational highlights.
"We recognize the macro headwinds our hospital customers are
facing and have made disciplined choices around our business to efficiently commercialize OLINVYK with our refocused sales and medical
affairs team. The recently signed Vizient contract will also help us reach important hospital decision-makers and further supports
OLINVYK's potential clinical and health economic benefits," said Carrie Bourdow, President and CEO of Trevena. "We're
also responding to our customers during this time by continuing to provide new OLINVYK data versus IV morphine in important areas such
as respiratory and cognitive function adverse events where there is a need to improve acute pain patients' outcomes. Lastly,
I'm pleased that we've advanced our novel S1P receptor modulator, TRV045, towards Phase 1 completion and I'm excited
about the potential opportunity in both diabetic neuropathic pain and epilepsy."
Second Quarter 2022 and Recent Corporate Highlights
OLINVYK (oliceridine) injection Milestones
"I believe these data are a very important addition
to the scientific evidence on OLINVYK and should be of great interest to practicing clinicians", said Ashish Khanna, MD, Associate
Professor of Anesthesiology and Vice Chair of Research, at Atrium Health Wake Forest Baptist Medical Center, "Any reduction
in neurocognitive impairment has potentially significant implications for postoperative recovery, where getting the patient out of bed
and moving as soon as possible is a critical component of modern multimodal approaches to post-surgical care. If these study outcomes
translate into clinical practice, they may potentially result in meaningful reductions in length of stay, improved ambulation, and avoidance
Financial Results for Second Quarter 2022
For the second quarter of 2022, the Company reported a net loss attributable
to common stockholders of $15.0 million, or $0.09 per share, compared to $14.0 million, or $0.09 per share, for the second quarter of
Cash and cash equivalents were $49.5 million as of June 30, 2022, which
the Company believes will be sufficient to fund the Company's operating expenses and capital expenditure requirements to mid-2023.
The cash balance does not include net proceeds from the Company's July 2022 registered direct offering of preferred shares.
Conference Call and Webcast Information
The Company will host a conference call and webcast with the investment
community on August 11, 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, Chief Financial
Title: Trevena Second Quarter 2022 Financial Results Conference Call & Webcast
Date: Thursday, August 11, 2022
Time: 8:00 a.m. ET
Conference Call Details: Toll-Free: 1-877-704-4453 International: 1-201-389-0920 Conference ID: 13730949
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=1557037&tp_key=b050aa54b6
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
About OLINVYK (oliceridine)
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
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.
LIFE-THREATENING 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.
NEONATAL 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.
RISK 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.
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
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.
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
Last updated: Aug 11, 2022