Trevena, Inc.

Good morning and welcome to the Trevena first quarter 2022 earnings conference call. All participants will be in listen-only mode. Should you need assistance, please signal a conference specialist by pressing the star key followed by zero. After today's presentation, there will be an opportunity to ask questions. Please note this event is being recorded. I'd now like to turn the conference over to Barry Shin, Senior Vice President and Chief Financial Officer. Please go ahead.

Good morning and welcome, everyone. With me today are Carrie Bordeaux, our President and CEO, Patty Drake, our Chief Commercial Officer, and our Chief Medical Officer, Mark Demitrak. As a reminder, Olenvic was approved by the FDA in August 2020 and indicated in adults for the management of acute pain severe enough to require an IV opioid analgesic and for whom alternative treatments are inadequate. The important safety information, including the box warning and the full prescribing information, are all available on olenvic.com. I'll remind you that Olenvic is an opioid that is a Schedule II controlled substance with a high potential for abuse similar to other opioids. We'll also be making forward-looking statements within the meaning of 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'm now turning the call over to Kerry for an overview of our first quarter of 2022 and recent business accomplishments. Kerry?

Thank you, Barry. Good morning, everyone, and thanks for joining us. Today, we'll provide an update on our refocused efforts for LNVIC and updates to our pipeline assets. Let's start with the LNVIC. From a macro perspective, we are seeing signs that hospitals are opening back up and things are improving, but it's taking time. Our field sales team is actively engaging burn, colorectal, and anesthesiology-related physicians and our refocused field strategy is building momentum on the ground. However, at the same time, I want to acknowledge that the launch has been slower than we had expected. We haven't seen the traction as quickly as we would have liked, and engaging inpatient hospital decision makers in the midst of the pandemic has certainly been difficult. I will say that I'm proud that the team has been able to adjust and is refocusing where needed. Patty will talk more about our renewed approach that she initiated mid-quarter And in part, this included moving sales reps over from the contract sales organization to our in-house Trevena team. We do believe this is having a positive impact and helping us to have a better approach to messaging and field execution. On the clinical side, our LENVIC post-approval studies are on track. Our medical science liaisons have now been trained on the exciting new respiratory physiology data. And we are adding this data to the hospital dossier for formulary committee reviews. We also plan to present the data at the American Society of Anesthesiologists conference in the fall. And in a few months, we expect to report top line results from the Olindic Cognitive Study versus IV morphine, which is a very interesting area for prescribers. At the end of the year, we expect to have results from the Cleveland Clinic Outcome Study looking at respiratory, cognitive function, and GI tolerability, all important data we plan to discuss with formulary committees. Patty and Mark will talk more about our plans for OLYMVIC later on the call, but before I turn it over, let me make a few more comments on the pipeline. First, like many of you, we were disappointed that the Data Safety Monitoring Board recently stopped the TRV-027 arm for the ACTIV-4 trial. Just a reminder, the NIH came to us to study TRV-027 in hospitalized COVID patients, and this study was completely funded by NIH. We are looking forward to seeing the complete analyses, and we'll certainly update you as we learn more. On TRV-045, our novel S1P receptor modulator, we expect to complete Phase I study by year-end. We're initially looking at TRV045 as a potential treatment for acute and chronic neuropathic pain secondary to diabetic peripheral neuropathy. This is a large opportunity. Over 25% of diabetic patients have neuropathic pain. And the NIH is studying TRV045 in preclinical models for epilepsy. We should have that data also in the second half of this year. so we could potentially have two shots on goal to pursue with CRV 045. Lastly, I'm pleased to announce that we received the first non-dilutive $15 million tranche from our financing we reported earlier in the quarter. There's a potential for another $25 million in funding from this deal, including a milestone payment upon first commercial sale of Alembic in China. So I know there's a lot to cover. We'll leave time for questions. But let me turn the call over to Patty to talk more about the Alimbic launch. Patty?