Trevena, Inc.

Greetings and welcome to the Truvina fourth quarter and full year 2022 earnings call. At this time, all participants are in a listen-only mode. A question and answer session will follow the formal presentation. If anyone should require operator assistance during the conference, please press star zero on your telephone keypad. As a reminder, this conference is being recorded. I would now like to turn the conference over to your host, Mr. Barry Shin, Chief Financial Officer for Truvina. Thank you. You may begin.

Great. Thanks. Good morning and welcome, everyone. With me today are Kerry Bordeaux, our president and CEO, Patty Drake, our chief commercial officer, and our chief medical officer, Mark Demitrak. As a reminder, Olindic was approved by the FDA in August 2020 and contains Olicerity, an opioid which is a Schedule II controlled substance with a high potential for abuse similar to other opioids. It's indicated in adults for the management of acute pain severe enough to require an IV opioid analgesic and for whom alternative treatments are inadequate. As with all opioids, serious life-threatening or fatal respiratory depression may occur in patients treated with Olenvic, as indicated in the boxed warning. Sedation is an established risk of opioids, including Olenvic, and is reflected in the Olenvic label. Nausea and vomiting were two of the most common adverse events reported in the controlled clinical trials. The important safety information, including the boxed warning and full prescribing information, are all available on olenvic.com. We'll also be making forward-looking statements under federal securities law. These statements are subject to risks and uncertainties related to our business, including those covered in our filings with the SEC. We undertake no obligation to update these statements beyond today. I'll now turn the call over to Kerry for an overview of our fourth quarter and recent business accomplishments. Kerry?

Thank you, Barry. Good morning, everyone, and thanks for joining. As you saw this morning, we announced exciting initial top-line data for Olenvic from Volition, the Cleveland Clinic-led real-world outcome study. We also analyzed electronic medical record data from Wake Forest, one of the Volition study sites. This morning, Mark will review top-line GI and cognitive outcomes and length of stay from these studies. We anticipate reporting the remaining datasets, including the respiratory outcome data, mid-year when they're available. In our commercialization efforts, the hospital market remains challenging, and the continued focus is on managing costs. Hospitals are facing margin pressures due to a whole host of factors, and we see this playing out in delays from key stakeholders, including pharmacy and therapeutics committees. We are continuing to highlight a limbic at key pharmacy and physician meetings, and appropriately positioning a limbic for complex patients in both the hospital inpatient and ambulatory surgical settings. You'll hear from Patty that we're seeing a clear shift to more procedures and more complex patients being treated in ASEs. Our efficient field sales team is engaging with top decision makers in the ASE setting, and the recently secured CMS pass-through status for a limbic has strengthened the reimbursement picture. Overall, we continue to focus our attention and resources on the best potential near-term and long-term growth areas for a limbic. Turning to our pipeline, we're very excited about the progress we're making with TRV-045, our novel S1P receptor modulator. As a reminder, we're interested in two areas, non-opioid treatment of acute and chronic neuropathic pain secondary to diabetic peripheral neuropathy and epilepsy. We're underway with two proof of concept studies, a target engagement study and a TMS study looking at brain electrical activity. We're expecting to complete enrollment for both studies by mid-year, with top-line data in the third quarter. We'll use the results of these studies to help further inform the path forward for TRV-045. In addition to the TRV-045 data and a LINVIC commercialization, potential partnering discussions are ongoing, and our partner in China, NUA, expects a regulatory decision on a LINVIC in the first half of this year. We have $38.3 million in cash and multiple upcoming milestones. Let me now turn the call over to Patty and Mark to provide more details on Alembic and TRV-045. Patty?