Full Press Release Details
Trevena Reports Second Quarter 2024 Results
and Provides Business Update
TRV045, novel S1P receptor modulator in development
for the treatment of acute and chronic neuropathic pain and epilepsy, demonstrated sustained long-term analgesic effect and differentiated
mechanism of action in preclinical models
$12 million financing completed, including non-dilutive
$2 million tranche and $10 million reduction in liabilities associated with existing ex-US royalty financing
CHESTERBROOK, Pa., August 8, 2024 (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, 2024 and provided an overview
of its recent operational highlights.
"We have continued to advance TRV045 in the second quarter,"
said Carrie Bourdow, President and CEO of Trevena. "We believe the most recent data further supports TRV045's therapeutic
potential and differentiated MOA and its potential to address the need for novel, non-opioid therapies for treating neuropathic pain and
Second Quarter 2024 and Recent Corporate Highlights
Financial Results and Other Updates for First Quarter 2024
the second quarter of 2024, the Company reported a net loss attributable to common stockholders of $4.9 million, or $0.23 per share, compared
to $8.0 million, or $0.69 per share in the second quarter of 2023. Cash and cash equivalents were $16.4 million as of June 30, 2024,
not including the $2 million in gross proceeds received from R-Bridge in July 2024.
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
TRV045 is a novel, highly 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. Subjects in both studies referenced in this press release were
enrolled outside of the United States, and the studies were not conducted under the Investigational New Drug Application for TRV045.
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.
SERIOUS AND LIFE-THREATENING RISKS FROM USE
Addiction, Abuse, and Misuse
Because the use of 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 prior to prescribing
and reassess all patients regularly for the development of these behaviors and conditions.
Life-Threatening Respiratory Depression
Serious, life-threatening, or fatal respiratory depression may occur
with use of OLINVYK, especially during initiation or following a dosage increase. To reduce the risk of respiratory depression, proper
dosing and titration of OLINVYK are essential.
Risks From Concomitant Use With Benzodiazepines Or Other CNS
Concomitant use of opioids with benzodiazepines or other central
nervous system (CNS) depressants, including alcohol, may result in profound sedation, respiratory depression, coma, and death. Reserve
concomitant prescribing of OLINVYK and benzodiazepines or other CNS depressants for use in patients for whom alternative treatment options
Neonatal Opioid Withdrawal Syndrome
If opioid use is required for an extended period of time in a pregnant
woman, advise the patient of the risk of NOWS, which may be life-threatening if not recognized and treated. Ensure that management by
neonatology experts will be available at delivery.
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,
which can occur at any dosage or duration, 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.
OLINVYK is contraindicated in patients with:
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.
are encouraged to report suspected adverse events of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.
see www.OLINVYK.com for full prescribing information including BOXED warning and important safety information
Forward-Looking Statements
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 words "anticipate," "believe," "estimate," "expect,"
"intend," "may," "plan," "predict," "project," "suggest," "target,"
"potential," "will," "would," "could," "should," "continue," and
similar expressions, constitute forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995.
Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors,
including: the expectations surrounding the continued advancement of the Company's product pipeline; the potential safety and efficacy
of the Company's product candidates and their regulatory and clinical development; the Company's intention to pursue strategic
alternatives for OLINVYK and the ability of any such strategic alternative to provide shareholder value; the expected financial and operational
impacts of the Company's decision to reduce commercial support for OLINVYK; the status, timing, costs, results and interpretation
of the Company's clinical trials or any future trials of any of the Company's investigational drug candidates; the uncertainties
inherent in conducting clinical trials; expectations for regulatory interactions, submissions and approvals, including the Company's
assessment of discussions with FDA; available funding; uncertainties related to continued listing on NASDAQ; uncertainties related to
the Company's intellectual property; uncertainties related to other matters that could affect the availability or commercial potential
of the Company's therapeutic candidates and approved product; and other factors discussed in the Risk Factors set forth in the Company's
Annual Report on Form 10-K and Quarterly Reports on Form 10-Q filed with the Securities and Exchange Commission (SEC) and in
other filings the Company makes with the SEC from time to time. In addition, the forward-looking statements included in this press release
represent the Company's views only as of the date hereof. The Company anticipates that subsequent events and developments may cause