Catherine Okoukoni

Catherine Okoukoni asked about potential risks associated with using the ordinal two-step DRSS endpoint in the DR program, particularly with a smaller patient population and concerns about a higher placebo effect.

Answer

Dr. Pravin Dugel (Executive Chairman, President and CEO) expressed strong confidence in the ordinal two-step DRSS endpoint for the DR program, citing overwhelming success data from the Helios 1 study, where a single XPAXLY injection showed favorable results across all parameters at week 48. He also highlighted that Helios 2 has an FDA-approved SPA, validating the study design and endpoint for superiority trials.

Catherine Okoukoni inquired about the number of scripts and patients contributing to the $1.4 million in revenue reported for July, and the exact availability date of ECTERLEET in July post-approval.

Answer

Benjamin Palleiko, CEO, stated that ECTERLEET was available approximately 10 days following approval, with start forms received from the day of approval. Brian Piekos, CFO, clarified that revenue recognition follows ASC 606, recognizing revenue when the product is received by specialty pharmacies (stocking orders), with a subsequent lag to patient shipments.

Catherine Okoukoni of Citizens JMP requested a comparison of the cT1 imaging results from the IMPACT trial with those from competitor programs, asking for specific data ranges to contextualize Altimmune's 'best-in-class' claim.

Answer

Chief Medical Officer Dr. M. Scott Harris provided specific figures, stating pemvidutide showed a cT1 reduction of approximately 145-148 milliseconds. He contrasted this with publicly available data for Resmetirom (around 50-60ms) and Tirzepatide (up to 107ms), reinforcing that this result is another strong indicator of the drug's anti-inflammatory and anti-fibrotic activity.

Catherine Okoukoni, on for John Wolleben, requested details on the trial design for the 9682 program, the first candidate from the NDC platform, and asked about any specific safety concerns being monitored.

Answer

Dr. Dana Pizzuti, Chief Medical and Development Officer, indicated that more details would be provided at the upcoming R&D Day in June. She described the initial study as a standard dose-escalation design for oncology, with additional safety parameters since it will enroll patients directly.

On behalf of Jon Walden, Catherine Okoukoni asked how the PFIC launch in the U.S. and ex-U.S. is performing against expectations. She also inquired about the sustainability of the company's profitability into 2026.

Answer

CEO Christopher Peetz described the PFIC launch as 'quite a bit better than expectations,' crediting the team's execution and compelling Phase III data. CFO Eric Bjerkholt clarified that while the company was cash flow positive in Q1 and expects to be for the full year, GAAP profitability is not expected 'anytime soon' due to significant noncash charges.

Catherine Okoukoni from Citizens JMP asked for specifics on the 2-year open-label F4 data, including whether patients required dose adjustments and what the patient retention rate was over the two-year period.

Answer

Dr. Michael Charlton, Head of Clinical Development, clarified that 122 patients entered the second year of the study, with the presented data coming from 101 patients who completed a second VCTE scan. He also confirmed patients were on the 80-milligram dose.