Latest News by Industry
OLINVYK commercialization progresses with Vizient contract and receipt of CMS outpatient pass-through reimbursement
Positive Phase 1 topline results for TRV045, a novel S1P receptor modulator; no serious adverse events and PK profile supports anticipated once daily dosing
Targeted TRV045 proof-of-concept study to assess CNS activity planned for early 2023
Cash balance of $40.4 million at Q3 funds operations into Q3 2023
Company to host conference call today, November 9, 2022 at 8:00 a.m. ET
CHESTERBROOK, Pa., Nov. 09, 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 Company’s website.
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 MedInfo@Trevena.com.
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; uncertainties related to the ongoing COVID-19 pandemic, 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
daniel@lifesciadvisors.com
(617) 430-7576
PR & Media Contact:
Sasha Bennett
Associate Vice President
Clyde Group
Sasha.Bennett@clydegroup.com
(239) 248-3409
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 Sep 30, | Nine Months Ended Sep 30, | ||||||||||||||||
| 2022 | 2021 | 2022 | 2021 | ||||||||||||||
| Product revenue | $ | (438 | ) | $ | 112 | $ | (438 | ) | $ | 499 | |||||||
| License revenue | - | 69 | 20 | 69 | |||||||||||||
| Total revenue | (438 | ) | 181 | (418 | ) | 568 | |||||||||||
| Operating expenses: | |||||||||||||||||
| Cost of goods sold | 2,368 | 199 | 2,791 | 620 | |||||||||||||
| Selling, general and administrative | 7,683 | 10,438 | 29,003 | 28,351 | |||||||||||||
| Research and development | 5,266 | 3,404 | 14,816 | 9,489 | |||||||||||||
| Total operating expenses | 15,317 | 14,041 | 46,610 | 38,460 | |||||||||||||
| Loss from operations | (15,755 | ) | (13,860 | ) | (47,028 | ) | (37,892 | ) | |||||||||
| Other income | 460 | 89 | 363 | 257 | |||||||||||||
| Net loss | (15,295 | ) | (13,771 | ) | (46,665 | ) | (37,635 | ) | |||||||||
| Unrealized gain (loss) on marketable securities | $ | 32 | $ | - | $ | (28 | ) | $ | - | ||||||||
| Comprehensive loss | $ | (15,263 | ) | $ | (13,771 | ) | $ | (46,693 | ) | $ | (37,635 | ) | |||||
| Per share information: | |||||||||||||||||
| Net loss per share of common stock, basic and diluted | $ | (0.09 | ) | $ | (0.08 | ) | $ | (0.28 | ) | $ | (0.23 | ) | |||||
| Weighted average shares outstanding, basic and diluted | 170,725,392 | 164,510,570 | 167,276,563 | 162,811,136 | |||||||||||||
| TREVENA, INC. | |||||||||
| Condensed Balance Sheets | |||||||||
| (Unaudited, in thousands) | |||||||||
| Sep 30, 2022 | December 31, 2021 | ||||||||
| Assets | |||||||||
| Current assets: | |||||||||
| Cash and cash equivalents | $ | 22,431 | $ | 66,923 | |||||
| Marketable securities | 17,961 | - | |||||||
| Inventories | 785 | 2,352 | |||||||
| Prepaid expenses and other current assets | 1,363 | 1,448 | |||||||
| Total current assets | 42,540 | 70,723 | |||||||
| Restricted cash | 2,557 | 1,311 | |||||||
| Property and equipment, net | 1,570 | 1,841 | |||||||
| Right-of-use lease assets | 4,352 | 4,706 | |||||||
| Other assets | - | 1,543 | |||||||
| Total assets | $ | 51,019 | $ | 80,124 | |||||
| Liabilities and stockholders’ equity | |||||||||
| Current liabilities: | |||||||||
| Accounts payable, net | $ | 1,416 | $ | 4,547 | |||||
| Accrued expenses and other current liabilities | 6,794 | 3,847 | |||||||
| Current portion of loans payable, net | 174 | - | |||||||
| Current portion of lease liabilities | 873 | 792 | |||||||
| Total current liabilities | 9,257 | 9,186 | |||||||
| Loans payable, net | 13,359 | - | |||||||
| Leases, net of current portion | 5,672 | 6,309 | |||||||
| Warrant liability | 868 | - | |||||||
| Total liabilities | 29,156 | 15,495 | |||||||
| Common stock | 174 | 165 | |||||||
| Additional paid-in capital | 562,484 | 558,566 | |||||||
| Subscription receivable | - | - | |||||||
| Accumulated deficit | (540,767 | ) | (494,102 | ) | |||||
| Accumulated other comprehensive income (loss) | (28 | ) | - | ||||||
| Total stockholders’ equity | 21,863 | 64,629 | |||||||
| Total liabilities and stockholders’ equity | $ | 51,019 | $ | 80,124 | |||||