5/15/2023

speaker
Keith
Conference Operator

Hello, and welcome to the Trevena, Inc. First Quarter 2023 Earnings Call. All participants will be in listen-only mode. Should you need assistance, please see the World Conference Specialist for pressing the star key followed by zero. After today's presentation, there will be an opportunity to ask questions. To ask a question, you may press star, then one on your touch-tone phone. To withdraw your question, please press star, then two. Please note, today's event is being recorded. I would now like to turn the conference over to Barry Shin, Chief Financial Officer. Please go ahead, sir.

speaker
Barry Shin
Chief Financial Officer

Thanks, Keith. 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, Alimbic was approved by the FDA in August 2020 and contains olisaridine, 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 Olindic, as indicated in the box warning. The important safety information, including the box warning and full prescribing information, are all available on olindic.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 Carrie for an overview of our first quarter and recent business accomplishments. Carrie?

speaker
Kerry Bordeaux
President and CEO

Thank you, Barry. Good morning, everyone, and thank you for joining. We are excited about the opportunities and significant upcoming milestones for Trevena this year. Let's start with the recent news last week. We were pleased to announce that Noir, received approval for a LINVIC in China, and they expect first commercial sale in the third quarter of this year. As a result, Trevena is due to receive a $3 million milestone payment, and we're eligible to receive an additional $15 million upon first commercial sale of a LINVIC in connection with the Arbridge Financing Agreement. In the U.S., we continue to build upon the extensive data set for a LINVIC. We announced the initial top line data from the real world outcome study that we conducted with Cleveland Clinic. And we're on track to report new respiratory and health utilization data and cost analyses from this study this year. Although we acknowledge we're not where we need to be as it relates to U.S. Olympic sales. You'll hear from Patty additional information to support our belief that the recent strategic shift to focus on ambulatory surgery centers was the right one. Turning to TRV045, our novel S1P receptor modulator, we're very happy with the progress, as we now have two proof-of-concept clinical studies underway to support the continued development for potential use of TRV045 in epilepsy and chronic pain, two large market opportunities. Study enrollment is going well, and we're expecting top-line data in the third quarter of this year. We're also assessing TRV045 and other potential indications, such as orphaned seizure disorders. Given its unique profile and strong interest from potential partners, TRV045 may be an exciting near-term value driver for Trevena. As you can hear, the upcoming quarter will be a busy one for us. Let me now turn the call over to Patty and Mark to provide more details on Alembic and TRV045. Patty?

Disclaimer

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