Akebia Therapeutics, Inc. 2026 Q2 Earnings Call

Please go ahead. Thank you, and welcome to Akebia's second quarter 2026 financial results and business updates conference call.

Please note that a press release was issued earlier today, Wednesday, August 5th, detailing our second quarter 2026 financial results, and that release is available on the investors section of our website. For your convenience, a replay of today's call will also be available on our website after we conclude. Joining me today, we have John Butler, Chief Executive Officer, Dr. Steven Burke, our Chief Medical Officer, Nick Grund, our Chief Commercial Officer, and Erik Ostrowski, Chief Financial and Chief Business Officer. I'd like to remind everyone that this call includes forward-looking statements. Each forward-looking statement on this call is subject to risks and uncertainties that could cause actual results to differ materially from those described in these statements.

Additional information describing these risks is included in the financial results press release that we issued on August 5th, as well as in the Risk Factors and Management Discussion and Analysis section of our most recent annual and quarterly reports filed with the SEC. With that, I'd like to introduce our CEO, John Butler.

Thanks, Mercedes, and thanks to everyone for joining us this afternoon. As you know, we've been focused on two critical areas of our business that we believe will deliver both important therapeutic advances for patients and value to shareholders. Those are advancing our kidney disease pipeline and making Vafseo standard of care for the treatment of anemia due to CKD in dialysis patients. We've had incredibly important advances in both areas since we last spoke to you. Today, I'll start with research and development. I believe our pipeline is underappreciated, and clinical advancement of our rare disease pipeline specifically provides the greatest opportunity to build value. Earlier this week, we announced that we initiated the phase II basket trial to evaluate ebribafusp, previously known as AKB-097 and ADX-097, in IgA nephropathy, lupus nephritis, and C3 glomerulopathy.

We believe ebribafusp, a next-generation complement inhibitor, could be truly differentiated in the rare kidney disease space in these indications and others. Beyond this initial basket study, we're doing the work to prepare for a phase II study in ANCA-associated vasculitis and expect to start that study next year. Our other rare kidney asset, praliciguat, continues to enroll in its phase II study in FSGS. As with Ebri, we believe there are multiple indications where Proli can play an important therapeutic role. Again, we believe the mechanism of Proli will allow it to occupy a unique competitive position in these rare diseases that each have significant unmet need. Our third kidney disease clinical candidate is AKB-9090, which was in a phase I study in healthy volunteers. 9090 continues to move successfully through the SAD/MAD study, and we expect to report data early next year.

Following that data readout, our plan is that next year, our development team's efforts and our $ will be focused on Ebri and Proli, where we believe the largest opportunity to drive near-term value exists. Dr. Steven K. Burke, our Chief Medical Officer, is currently attending GlomCon Hawaii, where medical professionals around the world have met to discuss treatments for glomerular disease. That's the reason we're having our call this afternoon rather than our normal morning timing. I'll now ask Steve to share a few remarks on Ebri and Proli.

Steve? Thank you, John. We've built upon our team's commitment to patients and expertise in kidney disease to advance several programs into the clinic in 2026.

We believe our mid-stage pipeline products, ebribafusp and praliciguat, have the potential to deliver differentiated and targeted approaches to severe diseases with high unmet need. As John mentioned, we just initiated a phase II basket trial for Ebri. The goal of this trial is to evaluate the safety and efficacy of Ebri in patients suffering from diseases marked by complement activation in the kidney glomeruli, namely IgA nephropathy, lupus nephritis, and C3 glomerulopathy. These rare kidney diseases affect thousands of patients, and while there are therapies available, each requires lifelong treatment. The currently available treatments include complement inhibitors, which suppress the complement system in the blood, and many require frequent administration.

Importantly, they generally have a box warning for significant infection risk, and this profile creates concern for long-term use. In non-clinical studies completed by Q32 Bio, Ebri was shown to be targeted specifically to the sites of complement activation. In patients with complement mediated glomerular diseases, we believe Ebri should localize to the affected glomeruli, which have significant deposits of C3d, while avoiding complement inhibition in the blood. We highlighted this during our R&D day in April and expect the findings from non-clinical and phase I studies to be published in medical journals. During our R&D presentation, Dr. Jonathan Barratt, Mayer Professor of Renal Medicine from the University of Leicester, shared that he believed a complement inhibitor with this profile could be used long-term and in combination with B-cell-directed therapies such as APRIL and APRIL-BAFF inhibitors without the associated potential of systemic complement inhibition.

The recently initiated phase II BASKET trial is expected to enroll up to 30 patients and will evaluate a once-weekly subcutaneous dose of Ebri for 26 weeks in the main study, followed by a long-term extension study for responders. In the phase I study of Ebri in healthy volunteers, again conducted by Q32 Bio, this same dose achieved exposures necessary to provide tissue-specific complement inhibition without inhibiting the complement system in the blood. The primary endpoint of the phase II study is the incidence of adverse events, and secondary endpoints including the change in proteinuria and kidney function. In addition, the trial will measure Ebri pharmacokinetics and complement biomarkers in the blood and urine to detect if Ebri reduces complement activity in the kidney tissue while avoiding inhibition of the complement system in the blood.

The phase II BASKET trial is open label. We expect to report initial data in 2027. With regards to our phase II study of Proli in patients with FSGS, enrollment activities are ongoing. FSGS is characterized by focal and segmental scarring in the glomeruli. Proli is a small molecule that is designed to stimulate the soluble guanylate cyclase enzyme and has been shown in animal models of kidney disease to inhibit glomerular scarring and preserve kidney function. There are about 40,000 patients currently diagnosed with FSGS in the U.S. This trial will enroll up to 60 patients with primary or genetic FSGS in a randomized, double-blind, placebo-controlled trial. The primary endpoint is change in urine protein-creatinine ratio, or UPCR, from baseline to week 24. The secondary endpoint is partial remission of proteinuria, defined as a 40% UPCR reduction and a UPCR less than 1.5 grams per gram.

In a phase II study of diabetic kidney disease conducted by Cyclerion, Proli demonstrated rapid and sustained reduction in proteinuria as measured by urine albumin creatinine ratio, or UACR. We look forward to providing further updates on these studies. Now I will turn it back over to John.

Thanks, Steve. Now let's turn our attention to Vafseo and our efforts to make this important product standard of care. We had a very positive surprise this quarter when Dr. Geoff Block of U.S. Renal Care completed the planned interim analysis of the primary endpoint in the VOICE trial and found the statistical result significantly exceeded the pre-specified stopping criteria. Vafseo demonstrated a statistically significant and clinically meaningful reduction in the primary composite endpoint of all-cause mortality and hospitalization, with the result driven by a 10% reduction in hospitalization. USRC Kidney Research stopped the trial after a recommendation from the independent data monitoring committee and trial steering committee. For reference, the VOICE trial enrolled 2,116 patients.