CHESTERBROOK, Pa., Aug. 14, 2023 (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, 2023 and provided an overview of its recent operational highlights.
“This is an exciting time for Trevena as we near completion of proof-of-concept studies evaluating the potential for use of TRV045 in both epilepsy and pain,” said Carrie Bourdow, President and CEO of Trevena. “We anticipate achieving a range of other milestones in Q3, including new respiratory data for OLINVYK and receipt of a non-dilutive $15 million tranche from our ex-US royalty based financing. We look forward to updating you as these developments occur.”
Second Quarter 2023 and Recent Corporate Highlights
Financial Results for Second Quarter 2023
For the second quarter of 2023, the Company reported net revenue of $3.0 million, and a net loss attributable to common stockholders of $8.0 million, or $0.69 per share, compared to $15.0 million, or $2.26 per share in the second quarter of 2022.
Cash and cash equivalents were $28.1 million as of June 30, 2023, which the Company believes will be sufficient to fund the Company’s operating expenses and capital expenditure requirements into 2024. This cash balance does not include a $15 million non-dilutive tranche from the R-Bridge Financing that the Company anticipates receiving in the third quarter of 2023.
About OLINVYK® (oliceridine) injection
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.
IMPORTANT SAFETY INFORMATION
WARNING: 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
ADDICTION, 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.
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.
Limitations of Use
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.
CONTRAINDICATIONS
OLINVYK is contraindicated in patients with:
WARNINGS AND PRECAUTIONS
ADVERSE REACTIONS
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.
MEDICAL INFORMATION
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 This email address is being protected from spambots. You need JavaScript enabled to view it..
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.
About TRV045
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.
About Trevena
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 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 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; 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.
For more information, please contact:
Investor Contact:
Dan Ferry
Managing Director
LifeSci Advisors, LLC
This email address is being protected from spambots. You need JavaScript enabled to view it.
(617) 430-7576
Company Contact:
Bob Yoder
SVP and Chief Business Officer
Trevena, Inc.
(610) 354-8840
TREVENA, INC. | ||||||||||||||||
Condensed Statements of Operations | ||||||||||||||||
(Unaudited, in thousands except share and per share data) | ||||||||||||||||
Three Months Ended Jun 30, | Six Months Ended Jun 30, | |||||||||||||||
2023 | 2022 | 2023 | 2022 | |||||||||||||
Product revenue | $ | 21 | $ | - | $ | 27 | $ | - | ||||||||
License revenue | 3,000 | - | 3,000 | 20 | ||||||||||||
Total revenue | 3,021 | - | 3,027 | 20 | ||||||||||||
Operating expenses: | ||||||||||||||||
Cost of goods sold | 88 | 216 | 214 | 423 | ||||||||||||
Selling, general and administrative | 5,138 | 10,306 | 11,227 | 21,320 | ||||||||||||
Research and development | 3,991 | 4,291 | 7,900 | 9,550 | ||||||||||||
Total operating expenses | 9,217 | 14,813 | 19,341 | 31,293 | ||||||||||||
Loss from operations | (6,196 | ) | (14,813 | ) | (16,314 | ) | (31,273 | ) | ||||||||
Other income | (1,816 | ) | (168 | ) | 483 | (97 | ) | |||||||||
Net loss | $ | (8,012 | ) | $ | (14,981 | ) | $ | (15,831 | ) | $ | (31,370 | ) | ||||
Per share information: | ||||||||||||||||
Net loss per share of common stock, basic and diluted | $ | (0.69 | ) | $ | (2.26 | ) | $ | (1.49 | ) | $ | (4.74 | ) | ||||
Weighted average shares outstanding, basic and diluted | 11,580,128 | 6,621,083 | 10,592,586 | 6,620,942 | ||||||||||||
TREVENA, INC. | ||||||||
Condensed Balance Sheets | ||||||||
(Unaudited, in thousands) | ||||||||
June 30, 2023 | December 31, 2022 | |||||||
Assets | ||||||||
Current assets: | ||||||||
Cash and cash equivalents | $ | 28,097 | $ | 38,320 | ||||
Inventories | 901 | 906 | ||||||
Prepaid expenses and other current assets | 3,972 | 1,782 | ||||||
Total current assets | 32,970 | 41,008 | ||||||
Restricted cash | 540 | 1,960 | ||||||
Property and equipment, net | 1,343 | 1,488 | ||||||
Right-of-use lease assets | 3,955 | 4,224 | ||||||
Other assets | 51 | - | ||||||
Total assets | $ | 38,859 | $ | 48,680 | ||||
Liabilities and stockholders’ equity | ||||||||
Current liabilities: | ||||||||
Accounts payable, net | $ | 2,527 | $ | 2,372 | ||||
Accrued expenses and other current liabilities | 4,695 | 5,461 | ||||||
Current portion of lease liabilities | 954 | 899 | ||||||
Total current liabilities | 8,176 | 8,732 | ||||||
Loans payable, net | 14,176 | 13,430 | ||||||
Leases, net of current portion | 4,946 | 5,436 | ||||||
Warrant liability | 1,779 | 5,483 | ||||||
Total liabilities | 29,077 | 33,081 | ||||||
Common stock | 14 | 8 | ||||||
Additional paid-in capital | 573,371 | 563,362 | ||||||
Accumulated deficit | (563,603 | ) | (547,772 | ) | ||||
Accumulated other comprehensive income (loss) | - | 1 | ||||||
Total stockholders’ equity | 9,782 | 15,599 | ||||||
Total liabilities and stockholders’ equity | $ | 38,859 | $ | 48,680 | ||||
Last Trade: | US$1.68 |
Daily Change: | -0.29 -14.50 |
Daily Volume: | 200 |
Market Cap: | US$1.430M |
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