Outlook Therapeutics, Inc.

Greetings and welcome to the Outlook Therapeutics Corporate Third Quarter Fiscal Year 2024 Update Conference Call and Webcast. At this time, all participants are on 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. It is now my pleasure to introduce your host, Janine Thomas, Investor Relations. Thank you. Please go ahead. Thank you, Donna.

At this time, I'd like to remind our listeners that remarks made during this webcast may state management's intentions be least expectations for future projections, including but not limited to our expectations about the timing of clinical trials and commercial launch and the sufficiency of our cash resources. These are forward-looking statements and involve risks and uncertainties. Forward-looking statements on this call are made pursuant to the safe harbor provisions of the Federal Security Laws and are based on Outlook Therapeutics' current expectations, and actual results could differ materially. As a result, you should not place undue reliance on any forward-looking statements. Some of the factors that could cause actual results to differ materially from these contemplated by such forward-looking statements are discussed in the periodic report Outlook Therapeutics files with the Securities and Exchange Commission. These documents are available in the Investors section of the company's website and on the Securities and Exchange Commission's website. We encourage you to review these documents carefully. Additionally, certain information contained in this webcast relates to or is based on studies, publications, surveys, and other data obtained from third-party sources and the company's own estimates and research. While the company believes these third-party sources to be reliable, as of the date of this presentation, it is not independently verified and makes no representation as to the adequacy, fairness, accuracy, or completeness of or at any independent sources verified any information obtained from third-party sources. During the call management, we'll discuss non-GAAP financial measures, which are not prepared in accordance with generally accepted accounting principles. Definitions of these non-GAAP financial measures, along with reconciliations to the most direct comparable GAAP financial measures, are included in the Outlook Therapeutics third quarter's earnings release, which has been furnished to the SEC and is available on the company's website at ir.outlooktherapeutics.com. Joining us on the call from Outlook Therapeutics Leadership Team are Russell Trenary, President and Chief Executive Officer, and Lawrence Kenyon, Chief Financial Officer of Outlook Therapeutics. I'd now like to turn the call over to Russ Trenary. Please proceed.

Thank you, Janine, and thank you to everyone joining us for our third quarter fiscal year 2024 conference call and webcast. As we begin today's call, I think it's important for me to start with our mission. And that is quite simply to achieve the first ever approval for an ophthalmic formulation of Bevacizumab for the treatment of retina diseases, initially in the EU, UK, and US. We're working toward achieving that mission in real time. We've already received marketing authorization in both the European Union and the United Kingdom. and are advancing toward the launch of the first approved ophthalmic bevacizumab approved for the treatment of wet AMD in those key markets. We're also making good progress here in the United States with our ongoing NORS 8 clinical trial, which, if successful, will serve as the basis for resubmitting our BLA with the FDA, which we expect to occur in the first calendar quarter of 2025. More on that in a minute. Focusing on the European Union and the United Kingdom, We're very pleased with the decisions from both regulatory bodies and believe this is the culmination of all the hard work our colleagues and partners have been striving to achieve these past several years. I think it also speaks to and validates the data we have generated, the clinical studies we have conducted, and the CMC work we have completed. We are going to do everything we can to bring this important drug to as many patients as possible in these two territories. which combined represent the second largest market for wet AMD in the world. Now turning to commercialization, we're continuing with market access work and inventory planning for Germany and the UK and expected product availability in those markets in the first half of calendar 2025. Additionally, we're continuing discussions with organizations that have established EU infrastructure and will continue to evaluate potential partners in the EU. Turning to the U.S., we continue to make progress on our NORSATE study, a three-month non-inferiority study with an eight-week efficacy endpoint. NORSATE is progressing as planned, and we currently have 359, that's 359, of the planned 400 subjects enrolled. We continue to expect a complete enrollment before the end of the third quarter. Top line results from NORSATE are expected in the fourth quarter of this year, and if positive, should provide sufficient clinical data to resubmit our BLA with the US FDA in the first calendar quarter 2025. In addition, we've completed our planned Type C and Type D meetings with the FDA, and believe we have addressed the open CMC items that were received in the CRL. And now, it's my pleasure to turn the call over to Larry Kenyon, our Chief Financial Officer. Larry?