10/30/2025

speaker
Operator
Conference Operator

Good morning, ladies and gentlemen. Thank you for standing by, and welcome to the Appellate Pharmaceuticals Third Quarter 2025 Earnings Conference Call. Please be advised that today's conference is being recorded. I would now like to turn the call over to Evel Straynoski, Head of Investor Relations. Please go ahead.

speaker
Evel Straynoski
Head of Investor Relations

Good morning, and thank you for joining us to discuss Appellate's Third Quarter 2025 Financial Results. With me on the call are co-founder and Chief Executive Officer, Dr. Cedric Francois, Executive Vice President of Commercials, David Atchison, Chief Medical Officer, Dr. Caroline Baumel, and Chief Financial Officer, Tim Sullivan. Before we begin, let me 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 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, Eva. Before diving into our third quarter results and portfolio progress, I want to briefly highlight the unmet need that Aperis set out to tackle and why we are uniquely positioned to address that challenge. Aperis is a commercial stage biotech company targeting the over-activation of the complement system an innate defense mechanism in the immune system that protects the body from acute infection and illness. However, when complement is chronically unregulated, there can be a devastating effect on one's health, driving a broad range of serious, often life-threatening diseases. Most approved complement targeted therapeutics inhibit at C5, a downstream protein in the complement cascade. By only blocking this target, T5 inhibitors do not affect the upstream activity that drives inflammation and tissue damage. Similarly, inhibitors of factor B act earlier in the cascade and narrowly, reducing alternative pathway amplification, but allowing classical and lectin pathway activity to persist, leaving some disease activity unchecked. Appendices science is founded on a simple but powerful idea, to address complement-driven diseases at their source by targeting C3, the central hub where all complement pathways converge. By doing this, we take a fundamentally different approach that enables comprehensive disease control at the root cause. For decades, the prevailing view was that C3 could not be effectively modulated because of its central role in immune defense. Apedis solved this challenge by engineering pexetacoplan, a first-in-class C3 inhibitor that controls overactive complement while preserving essential immune function. The result is both a technological feat in drug design and a transformative clinical advancement for patients. This vision is what sets Aperis apart. We have mastered our core technology and redefined complement therapeutics. The scientific advantage underpins our success to date. Having now translated decades of innovation into two approved medicines across four serious diseases, Aperis is a commercial stage leader with a truly differentiated C3 platform. Cyphovrine is the first-ever treatment for geographic atrophy, having shown robust efficacy in slowing disease progression in the broadest patient population. And Pavelli has demonstrated best-in-class hemoglobin improvement in PNH and the ability to completely clear C3 deposits from the kidney. Together, these achievements underscore our unprecedented clinical innovation, and strengthen Apelis' competitive edge in complement science. Turning now to our business results. The third quarter was a period of further progress where we continued to build on our strong performance. A key milestone was the FDA approval of Empaveli for the treatment of patients 12 years and older with C3 glomerulopathy or primary immune complex membranoproliferative glomerulonephritis, or ICMPGM. This approval expands the addressable market for Empaveli by approximately 5,000 patients and marks a breakthrough therapy that delivers meaningful results across the trifecta of key disease control measures, including proteinuria reduction, EGFR stabilization, and substantial clearance of C3 deposits. With a broad label in hand, We are well-positioned for launch in a space where physicians consistently note that efficacy will drive treatment decisions. David will share more launch progress shortly. Moving to cyphovarine. Geographic atrophy is a devastating disease that progressively and permanently robs patients of their vision. Unfortunately, in managing GA, many retina specialists have adopted a wait-and-see approach. despite Cyphovry's well-established clinical profile that demonstrated robust, sustained, and increasing benefits with every other month dosing. Because of this, only about 10% of patients diagnosed with GA are treated with complement inhibitors today. In the near term, we expect a period of steady, measured injection growth, with the next inflection in growth to be driven by new tools and targeted market education initiatives that we plan to bring to market over the next 12 to 18 months. We believe these initiatives will re-accelerate the adoption of complement treatments and grow the overall GA market. Overall, our focus remains on leveraging our expertise in complement-mediated diseases to positively affect the lives of people living with serious illnesses. With this in mind, We continue to maximize our market opportunities for MPaveli, drive expansion for Cyphovry, and advance our pipeline. I will now hand the call over to David for an update on our commercial activities. David?

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