Trevena, Inc.

Greetings and welcome to Trevina's Inc. Second Quarter 2022 Earnings Conference 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, Mary Shin, CFO. Please proceed.

Thanks. 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, Olindic 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 full prescribing information, are all available on alinvic.com. 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'll now turn the call over to Carrie for an overview of our second quarter and recent business accomplishments. Carrie?

Thank you, Barry. Good morning, everyone, and thanks for joining. Today, we'll provide an update on Olindic progress, upcoming milestones for our pipeline assets, and the corporate actions we've taken to ensure our company resources are focused on our highest priorities. Let's start with an update on Olindic. It's important to acknowledge that the market environment remains challenging. The good news is that hospitals continue to reopen. but the pace remains slow and inconsistent due to the emerging COVID variants and staffing shortages. This impacts the timing of formulary meetings and the cadence of decision-making among hospital key opinion leaders. Despite these challenges, we've stayed focused on delivering a robust post-market clinical outcomes program, building a first-class field sales force, and ensuring we have the appropriate amount of financial and human resources necessary to efficiently drive performance. A few key highlights from this quarter I'd like to reference. On the clinical front, we announced positive top-line cognitive function data last month for Olenvic. We've been speaking with physician experts in this space about the data, and they recognize that this is an important outcome for Olenvic, as cognitive function may impact hospital length of stay, and other health economic events that potentially drive costs to the overall system. Mark will provide a more comprehensive review of the data during his comments. Remember that we previously announced positive respiratory physiology data for Olympic, and we're on track to complete the Cleveland Clinic Outcome Study looking at respiratory, GI, and also cognitive function later this year. We believe these datasets will further strengthen the case for LNVIC to physicians, formulary committees, and payers. We were also very excited to announce a significant contract win in July with Vizion, a leading hospital group purchasing organization. Patty's team did a great job getting this contract, and she'll provide more details in her section. On the business side, We recently announced the decision to reduce costs and realign company resources. This included an approximate 25% reduction in company full-time employees. We also ended the agreement with our contract sales organization, Cineos, and we now have our sales and medical affairs team completely in-house. These decisions enable us to sufficiently resource our ongoing key strategic priorities, driving commercial adoption of Olindic and developing TRV045. On the topic of TRV045, this is our novel S1P receptor modulator. We remain on track to complete the phase one study in the second half of this year. And as a reminder, we're developing 045 as a potential treatment for acute and chronic neuropathic pain. secondary to diabetic peripheral neuropathy. This is a large market opportunity. Over 5 million people in the U.S. suffer from DNP, or diabetic peripheral neuropathy, and there's a need for new mechanisms of action and more efficacious medication. In addition to neuropathic pain, we're also working with the NIH to study TRV045 as a potential treatment for epilepsy. with possible application in refractory epilepsy and other rare or orphan seizure disorders. And today, Mark's excited to share with you an update on that program during his comments. We finished the quarter with $49.5 million in cash, and we believe we have sufficient runway to fund our operating expenses and capital expenditure requirements to mid-2023. Let me now turn the call over to Patty to talk more about the Olympic Lodge. Patty?