Denis Reznik

Denis Reznik of Raymond James asked for a profile of the ideal physician prescriber for Anafilm and whether the company remains confident in achieving 80% payer coverage within six months of launch.

Answer

CEO Daniel Barber affirmed confidence in achieving broad and competitive payer coverage. Chief Commercial Officer Sherry Korczynski described the prescriber base as very broad but stated the initial launch focus will be on high-prescribing allergists, who are enthusiastic about the product's innovation and potential to improve patient adherence.

Denis Reznik of Raymond James questioned the ex-U.S. partnership strategy for Anaphylm, specifically regarding regulatory submissions and deal timing, and asked to define the ideal early adopter prescriber profile.

Answer

CEO Daniel Barber stated that responsibility for ex-U.S. regulatory submissions is partner-dependent, but Aquestive's team can support or lead the effort. He noted partnership discussions are active but declined to provide a specific timeline. Executive Sherry Korczynski described the ideal early adopter as a physician who sees many allergy patients and hears feedback about the inconvenience of current devices. She cited market research showing 95% of physicians believe a film option fills an unmet need.

Denis Reznik of Raymond James inquired about the timeline for the FDA end-of-Phase 2 meeting for Xpro, the sentiment from the AAIC conference, and the progress and ideal structure of potential strategic partnerships.

Answer

CEO David Moss stated that the briefing book for the FDA meeting is being prepared and a meeting is expected in Q4 2025, after which any partnership would likely be considered. VP of Neuroscience, CJ Barnum, described feedback from the AAIC conference as very promising, highlighting strong interest in Xpro's neuropsychiatric benefits and its favorable safety profile (lack of ARIA). Moss added that a partnership would likely occur in the first half of the next year, post-FDA meeting, and would be structured to finance a registration trial.

Denis Reznik of BMO Capital Markets inquired about the next steps for the XPro program following a positive data readout, including the timeline for a Phase III trial, potential enrollment metrics, the stability of the FDA review team, and the market's reception to the recent AD/PD poster presentation.

Answer

CEO RJ Tesi stated that while specific Phase III trial design details are pending data and FDA discussions, the company aims for an end-of-Phase II meeting in Q4 2026. He expressed confidence in the FDA's operational stability for drug development. Dr. CJ Barnum, Head of Neuroscience, added that the FDA is awaiting data to comment on the EMAC endpoint and noted that the AD/PD conference reception was positive, with significant interest in both a non-amyloid therapy and the novel EMAC cognitive measure.

Denis Reznik from Raymond James requested an update on ex-US partnership discussions, sought more color on the significance of the three-year data for PCRX-201, and asked for details on the ongoing Phase II ASCEND study, including site counts.

Answer

CEO Frank Lee confirmed active and progressive dialogues for ex-US partnerships as part of the '5x30' strategy. He highlighted the significant excitement around the three-year PCRX-201 data, noting its rarity in OA studies. He also stated the ASCEND study enrollment is progressing well, with Part A expected to complete by year-end and initial data anticipated in late 2026 or early 2027.

Denis Reznik, on for Gary Nachman of Raymond James, asked about expectations for the extension trial, the success criteria for preventing weight regain, and the specific safety data reviewed by the independent data monitoring committee (IDMC).

Answer

Chairman, CEO, and President Dr. Mitchell Steiner explained the extension study aims to show enobosarm can maintain muscle and prevent the rebound fat gain after stopping GLP-1s, emphasizing the focus is on adiposity. Chief Scientific Officer Dr. K. Barnette added that they expect fat gain in the placebo group and hope enobosarm minimizes this. Dr. Barnette also detailed that the IDMC reviewed unblinded, individual patient safety data up to December 20, 2024, including demographics and treatment assignments.