11/8/2021

speaker
Conference Operator
Call Operator

I would now like to hand the conference over to your host today, Meredith Kaya, Vice President of Investor Relations. Please go ahead.

speaker
Meredith Kaya
Vice President of Investor Relations

Good afternoon, and thank you for joining us to discuss Appellus' third quarter 2021 financial results. With me on the call are co-founder and chief executive officer, Dr. Cedric Francois, chief commercial officer, Adam Townsend, chief medical officer, Dr. Federico Grossi, and chief financial officer, Tim Sullivan. Before we begin, I would like to point out that we will be making forward-looking statements that are based on our current expectations and beliefs. These statements are subject to certain risks and uncertainties, and our actual results may differ materially. I encourage you to consult the risk factors discussed in our SEC filings for additional detail. Now, I'll turn the call over to Cedric.

speaker
Dr. Cedric Francois
Co-founder and Chief Executive Officer

Thank you, Meredith, and good afternoon to everyone joining us today for our conference call. The third quarter was another exceptional period for Atedes, highlighted by strong U.S. commercial execution for Empa-Veti in P&H, our phase three Derby and Oaks data, which we believe position back to become the first treatment for GA and the continued advancement of our pipeline. Our achievements this past quarter underscore the broad potential of our unique approach of targeting C3 and further reinforce our leadership position in complement. I will start with the most significant event of the quarter, which was the top line results from Derby and Oaks. In these studies, pexetacoplans showed a clinically meaningful reduction in GA lesion growth and a favorable safety profile with both monthly and every other month dosing. Importantly, pexetacoplans showed an even greater effect in patients with extra fovea lesions, supporting treatment earlier in disease progression. Fede will review these results shortly. With these data, We believe Pexita Copeland is a breakthrough for the millions of people living with GA, a relentless disease that is a leading cause of blindness worldwide. We are thrilled with these results, but we understand that there remains uncertainty within the investment community right now, both in regards to our path forward in GA and in how we intend to capitalize the company. Gaining clarity on both is a high priority for us in the near term. On the regulatory path, we will be meeting with the FDA to discuss our submission strategy and plan to share feedback with you before the end of the year. Regarding funding needs, as Tim will detail later, we are taking a thoughtful approach as we evaluate various financing strategies so that we are well positioned for the future. Turning to Empavel, the first and only targeted C3 therapy approved for the treatment of PNH. In our first full quarter since launch, Empaveli delivered $5.3 million in net product revenue, exceeding our expectations and showed strong momentum across each of our launch metrics. Additionally, Texeta Copeland, which will be known as Aspaveli in the EU and marketed by SOBI, received a positive CHMP opinion last month. We expect a decision regarding approval from the European Commission by the end of this year. further advancing our goal to elevate the standard of care for PNH patients around the world. If approved, Asklaveli will become the first new therapeutic approach for PNH in the European Union since 2007. Our efforts in PNH are just the first steps in building our rare disease franchise. Together with Shobi, we are continuing to advance a robust portfolio across multiple indications. We have a steady cadence of milestones over the next 12 to 18 months, including the start of three late-stage trials designed to support registration in four separate indications. We are also continuing to enroll patients in our potentially registrational Phase II ALS study. Ultimately, our ambition is to become the global leader in complement. Bexita Copeland represents the foundation for this goal. and is our most immediate opportunity. However, behind these programs, we have a growing portfolio of candidates across several modalities that will allow us to address a broad range of complement-driven diseases. We look forward to providing more details on all of these efforts as the programs advance. And let me now turn the call over to Adam for a discussion on our commercial efforts. Adam.

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