Outlook Therapeutics, Inc.

Hello and welcome to the Outlook Therapeutics inaugural quarterly update conference call and webcast. As a brief reminder, all participants are currently in a listen-only mode. If anyone requires operator assistance during the event, please press star zero on your telephone keypad. Following the presentation, there will be a question and answer session. Note that this webcast is being recorded at the company's request and a replay will be made available on the company's website following the end of the event. It is now my pleasure to turn the call over to Janine Thomas of Investor Relations.

Thank you, Daryl. At this time, I would like to remind our listeners that remarks made during this webcast may state management's intentions, beliefs, expectations, or future projections. 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 securities 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 Outlook Therapeutics Annual Report on Form 10-K for the fiscal year ended September 30, 2023, and in other reports and 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 that these third-party sources to be reliable as of the date of this presentation, that has not independently verified and makes no representation as to the adequacy, fairness, accuracy, or completeness of that, or that any independent source has verified any information that comes from third-party sources. During the call, the company will discuss non-GAAP financial measures, which are not prepared in accordance with U.S. generally accepted accounting principles. Definition of these non-GAAP financial measures, along with reconciliations at the most directly comparable GAAP financial measures, are included in our second quarter 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 would now like to turn the call over to Russ. Please proceed.

Thank you, Janine. And thank you to everyone joining us for the company's first earnings call and webcast. To begin, I feel it's important to restate our mission and what we are working to accomplish. Our goal is to enhance the standard of care in the retina anti-VEGF space by achieving the first approval for an ophthalmic formulation of Bevacizumab for the treatment of retina diseases in the United States and Europe. Accomplishing this with our product candidate, ONS 5010, could provide people afflicted with wet AMD an effective form of bevacizumab that meets the FDA and EU's stringent efficacy, safety, and quality standards. So this is not a distant, long-term goal for us. Following our recent positive opinion from the CHMP, we believe we are on the cusp of receiving a potential approval for ONS 5010 in Europe, which we expect this quarter, calendar Q2 2024, and we are making significant potential progress for approval in the United States as well. We also submitted our MAA, or Marketing Authorization Application, to the Medicines and Healthcare Products Regulatory Agency in the United Kingdom. So in Europe, which represents a significant market opportunity for us, we're making tremendous progress and expect to be in a position to launch in the UK and in the EU in the first quarter of calendar 2025. Regarding the United States, we've been actively engaged with the FDA and will continue to do so leading up to our expected BLA resubmission. As part of these interactions, earlier this year we reached agreement with the FDA on a special protocol assessment, or SPA, for NORS 8, our ongoing 90-day non-inferiority study for which we inspect top line data in the fourth calendar quarter of this year, 2024. Shortly thereafter, our goal is to resubmit our BLA by the end of this calendar year. Turning to our financial picture, we believe we're strongly positioned. We recently closed a private placement with gross proceeds of up to $172 million. Of that, $65 million is in cash from the issuance and sale of common stock, which are accompanied by warrants to purchase shares of common stock, and that's already been received, plus an additional $107 million, which will be available upon the full cash exercise of the warrants. Assuming the full cash exercise of the warrants, we expect our accessible capital to fund the business through our potential approval and commercial launch in parts of Europe and through the completion of NorthSafe, plus a potential FDA approval and the subsequent launch in the United States. Of note, this financing included participation by a couple longtime supporters of the company, as well as a good number of additional fundamental healthcare-focused institutional investors. Larry will speak to this a little bit later in the call. I'd like to drill down a little bit more on our activities in the EU and UK. In the EU, we expect potential approval this quarter, and in the UK, we expect potential approval in the third quarter of calendar 2024, this year, with initial launches in the first quarter of calendar 2025. As we await potential approval in the EU, We're working with Sincora, formerly AmerisourceBergen, and their EU units to leverage their existing infrastructure and expertise to support launching ONS 5010 ourselves in Europe. I'd like to emphasize the importance of the opportunity in Europe, which is the second largest market for wet AMD globally. So not only will it potentially be where we start generating revenue in the first half of calendar 2025, but it will validate all the hard work we've done to date. First, it will validate our entire development program for ONS 5010, including the positive safety and efficacy data we generated in our pivotal NORS II trial, plus the learnings from NORS I, which informed our NORS II study design. Also, the additional patient exposures established in NORS III to meet FDA's required safety population size And it also puts an exclamation point on the entirety and the quality of our CMC work. Now turning to the U.S. We reached agreement with the FDA on our SPA and launched NORSATE, a three-month non-inferiority study with an eight-week efficacy endpoint. This study has progressed as planned, and we've already enrolled over 30% of the patients to date. We continue to expect to complete enrollment in the third quarter of this year as planned and be in a position to report top line data and resubmit our BLA in the fourth quarter of this year. Additionally, we're meeting with the FDA in Type C and Type D meetings in order to discuss the resolution of the C and C questions and comments that were received in the CRL last year. The Type C and D meetings are not required by FDA. These interactions are at our request, with the goal of doing everything in our power to address the FDA's CMC questions while streamlining the process for resubmitting our BLA. Importantly, we anticipate these open CMC items will be resolved in calendar Q2 and Q3 this year, 2024, in advance of the NORSATE data readout. I'd also like to reiterate that the CMC comments from the CRL do not have any impact on our current supply of ONS 5010. We're working with reputable manufacturers that are actively using ONS 5010 from these partners in the ongoing NORSATE study. We believe that if successful, these activities will be sufficient for potential approval in the United States in calendar 2025. And now, It's my pleasure to turn the call over to Larry Kenyon, our Chief Financial Officer.