Full Press Release Details
Trevena Reports Third Quarter 2022 Results and
Provides Business Update
OLINVYK commercialization progresses with Vizient contract and receipt
of CMS outpatient pass-through reimbursement
Phase 1 topline results for TRV045, a novel S1P receptor modulator; no serious adverse events and PK profile supports anticipated
Targeted TRV045 proof-of-concept study to assess CNS activity planned
Cash balance of $40.4 million at Q3 funds operations into Q3 2023
Company to host conference call today, November 9, 2022 at
CHESTERBROOK, Pa., November 9, 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 third quarter ended September 30, 2022, and provided
an overview of its recent operational highlights.
"We are pleased that OLINVYK received CMS pass-through reimbursement
for ambulatory surgical centers and hospital outpatient settings. Our recently announced relationship with Vizient is advancing, which
enables us to efficiently manage and allocate resources in this challenging hospital environment," said Carrie Bourdow, President
and CEO of Trevena. "We are also excited to report positive topline Phase 1 data for our novel S1P receptor modulator, TRV045. The
results of the study support potential advancement of TRV045 in CNS areas such as non-opioid chronic pain and epilepsy. Based on this
promising clinical data, we plan to move forward with a targeted proof-of-concept study with near term expected data."
Third Quarter 2022 and Recent Corporate Highlights
Financial Results for Third Quarter 2022
For the third quarter of 2022, the Company reported a net loss attributable
to common stockholders of $15.3 million, or $0.09 per share, compared to $13.8 million, or $0.08 per share in the third quarter of 2021.
Results for the third quarter of 2022 include a $2.2 million non-cash
valuation adjustment for slow-moving or obsolete inventory due to the uncertainty of commercial activities underlying OLINVYK sales, which
is recognized as a cost of goods expense. The results also include a $0.4 million non-cash adjustment in reserves for potential returns
of OLINVYK held at wholesalers, which results in negative product revenue.
Cash, cash equivalents and marketable securities totaled $40.4 million
as of September 30, 2022, which the Company believes will be sufficient to fund the Company's operating expenses and capital
expenditure requirements into the third quarter of 2023.
Conference Call and Webcast Information
The Company will host a conference call and webcast with the investment
community on November 9, 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 Officer.
| Title: | Trevena Third Quarter 2022 Financial Results Conference Call & Webcast | |
| Date: | Wednesday, November 9, 2022 | |
| Time: | 8:00 a.m. ET | |
| Conference Call Details: | Toll-Free: 1-800-954-0687 International: 1-212-231-2935 Conference ID: 22021290 |
| 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=1572499&tp_key=b8766e3409 |
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
OLINVYK (oliceridine) injection
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
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 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.
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.
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
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 disorder.
For more information, please visit www.Trevena.com
Forward-Looking Statements
Any statements 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