Trevena Reports First Quarter 2024 Results and Provides Business Update TRV045, novel S1P receptor modulator for chronic pain and epilepsy, continues to demonstrate a favorable tolerability profile Ongoing clinical PK st

Reports First Quarter 2024 Results and Provides Business Update

novel S1P receptor modulator for chronic pain and epilepsy, continues to demonstrate a favorable tolerability profile

clinical PK study with optimized formulation of TRV045 advances, with data expected 2H 2024

Pa., May 15, 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 first quarter

ended March 31, 2024 and provided an overview of its recent operational highlights.

clinical development continued to progress in the first quarter, and we believe its novel MOA, once daily, oral dosing and favorable

tolerability profile, has the potential to address the significant unmet need for non-opioid therapies in pain and for novel mechanisms

in epilepsy" said Carrie Bourdow, President and CEO of Trevena.

Quarter 2024 and Recent Corporate Highlights

Results and Other Updates for First Quarter 2024

the first quarter of 2024, the Company reported a net loss attributable to common stockholders of $7.7 million, or $0.36 per share, compared

to $7.8 million, or $0.81 per share in the first quarter of 2023. Cash and cash equivalents were $23.6 million as of March 31, 2024.

May 13, 2024, the Company received a decision letter from the Nasdaq Hearings Panel granting the

Company an extension until August 28, 2024, subject to certain conditions, to regain compliance with the Nasdaq continued listing requirements,

including the minimum bid price and shareholders' equity requirements. All delisting actions are stayed during the additional

extension period granted by the Panel following the Appeal Hearing. While the Company is investigating

a range of options to regain compliance with the Nasdaq continued listing requirements, there can

be no assurance that the Company will be able to regain compliance before the dates required by Nasdaq or at all.

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.

more information, please visit www.Trevena.com

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.

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.

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

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

Respiratory Depression

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.

From Concomitant Use With Benzodiazepines Or Other CNS Depressants

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 are inadequate.

Opioid Withdrawal Syndrome

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.

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.

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]:

cumulative total daily dose should not exceed 27 mg.

is contraindicated in patients with:

reactions are described in greater detail in the Prescribing Information.

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.

see www.OLINVYK.com for full prescribing information including BOXED warning and important safety information

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 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 the Company's views to change. However,

while the Company may elect to update these forward-looking statements at some point in the future, it specifically disclaims any obligation

to do so, except as may be required by law.

more information, please contact:

Chief Business Officer & Head of Commercial Operations

Condensed Statements of Operations

(Unaudited, in thousands except share and per share data)

Condensed Balance Sheets

(Unaudited, in thousands)