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Trevena, Inc.
3/31/2022
Greetings, and welcome to the Trevena fourth quarter and full year 2021 earnings conference call. Currently, all participants are on 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. It is now my pleasure to introduce Barry Shen, 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 Demetrek. As a reminder, Olindig was approved by the FDA in August 2020 and is 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 alindic.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 2021 and recent business accomplishments
Thank you, Barry. Good morning, everyone, and thanks for joining us today. 2021 was a year of progress and growth for Tribuna. While we launched our novel product, Alimbic, during a time that our hospital customers were navigating the changing environment of the pandemic, the lessons learned from this past year of launch have enabled us to refine our commercial strategy to drive more rapid adoption of Alimbic in 2022. And although we've experienced launch challenges, our confidence has grown in the potential for Alimbic in our core markets. We've also been adding to the clinical database for Alimbic. As you may have seen in our press release this morning, we now have positive top-line data in a new respiratory physiology study in complex subjects versus IV morphine. And we're expecting data from two other ongoing studies later this year that may further demonstrate clinical outcomes not only in respiratory depression, but also in nausea, vomiting, and incognito function, all important areas that matter to healthcare providers and formulary decision makers. We continue to advance our novel pipeline as well. Two programs I'll highlight. For TRB045, our novel S1P receptor modulator, we began phase one clinical development to support the indication in diabetic neuropathic pain patients. We expect to complete phase one in the second half of this year. For TRV-027, currently being studied in COVID patients, the NIH active team, led by Vanderbilt University Medical Center, has continued to add sites and enroll hospitalized patients, and they expect top-line data from this study mid-this year. Importantly, the NIH team has now expanded the trial internationally and will begin enrolling patients outside the U.S. in the coming months. While this study will certainly be important for COVID patients, we believe the study may also support the utility of TRB-027 in other disease areas, such as non-COVID acute lung injury or acute respiratory distress syndrome. Lastly, our partner in China, Noir, recently announced the submission of their NDA for a limbic. Building on this progress, we were able to unlock immediate and significant value by completing the financing we announced earlier today. We will receive up to $40 million backed by the ex-U.S. royalty and a small cap royalty on U.S. Olympic sales. This transaction strengthens our balance sheet and provides value for an asset that was very clearly not reflected in our share price. Let me now turn the call over to Patty to talk more about our U.S. Olympic launch activities. Patty?
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