Trevena, Inc.

Greetings and welcome to Tribina Inc. Third Quarter 2023 Earnings Call. At this time, all participants are in a listen-only mode. A brief 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. It is now my pleasure to introduce your host, Barry Shin, Chief Financial Officer, Thank you, Mr. Shin. You may begin.

Good morning and welcome, everyone. With me today are Kerry Bordeaux, our president and CEO, Patty Drake, our chief commercial officer, and Mark Demitrak, our chief medical officer. We're also joined by Dr. Daniel Klaue, a key opinion leader and paid scientific consultant with Trevena, to provide his views on our recent TRV-045 proof-of-concept data. Dr. Klaue is a rheumatologist, a leading expert of CNS mechanisms in pain, and Professor of Anesthesiology, Medicine, and Psychiatry at the University of Michigan. We'll also be making forward-looking statements on our 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. As a reminder, Olindvik was approved by the FDA in August 2020 and contains Oliceridine, 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 Alimbic, as indicated in the boxed warning. The important safety information, including the boxed warning and full prescribing information, are all available on alimbic.com. I'll now turn the call over to Carrie for an overview of our third quarter and recent business accomplishments. Carrie?

Thank you, Barry. Good morning, everyone, and thank you for joining. We're pleased to report a quarter of significant milestones achieved. Let's start with TRV-045, our novel S1P receptor modulator that we're studying for potential use in chronic pain and epilepsy, two large market opportunities. During the quarter, We released very promising top line results from two phase one proof of concept studies where we demonstrated a statistically significant dose dependent effect in a validated model of neuropathic pain and statistically significant EEG changes and evidence of early reduction in cortical excitability in the TMS study, a biomarker for epilepsy. Both studies highlighted TRV-045's unique mechanism of action and CNS target engagement. In addition, last month, we also announced favorable top-line safety and tolerability data from these studies. We believe the data generated to date supports the therapeutic potential of TRV-045 as a non-opioid with a novel mechanism of action, expected once daily dosing, and a favorable safety tolerability profile. Mark will provide more details from the studies during his comments. We're also pleased to be joined today by Dr. Daniel Klaw, who will provide his thoughts on TRV-045 and its potential fit in the therapeutic landscape. In addition, as we previously mentioned, the NIH continues to study TRV-045 for seizure prevention, and we're expecting data from their non-clinical study by the year end. We're actively planning next steps to advance TRV-045 in patients on our own or with a strategic partner for the potential treatment of neuropathic pain, epilepsy, and other CNS disorders. Turning to a limbic, we announced the completion of the initial analysis of respiratory data from the 200-patient volition study that was generated at Cleveland Clinic and Wake Forest Baptist Health. The results were presented at the recent American Society of Anesthesiologists meeting last month. Alembic was featured in three abstracts at the meeting, including a podium presentation. Our US Alembic commercial business remains challenging. We're efficiently deploying resources and pursuing our contracting strategy, and we'll continue to assess performance and the best path forward for Alembic. Lastly, related to Alimbic, during the quarter, we received $15 million as a result of the first commercial sale of Alimbic by Noir, our licensee in China, in connection with the Arbridge financing agreement. Let me now turn the call over to Mark to provide more details on TRV-045. Mark?