Arthur He

Arthur He questioned the proportional growth contribution to LUPKYNIS sales from rheumatologists versus nephrologists and whether the impact of ACR guidance on prescribing has reached a steady state or is still in its early stages. He also asked Dr. Keenan to remind about the anti-drug antibody (ADA) situation for aritinercept in healthy volunteers.

Answer

Peter Greenleaf, President and CEO, indicated a slight increase in rheumatologist prescribers, noting that the business is fairly evenly split but slightly favors rheumatologists, a trend increasing over the last two years. He emphasized that ACR guidelines promote earlier diagnosis and aggressive treatment, which is still an ongoing process, with room for improvement in diagnostic frequency and adherence to treat-to-target goals. Dr. Greg Keenan, Chief Medical Officer, confirmed low-titer anti-drug antibodies (ADAs) were observed at doses of 25mg and above for aritinercept in healthy volunteers, but noted no impact on injection site reactions or pharmacokinetic/pharmacodynamic profiles.

Arthur He from H.C. Wainwright asked about the contribution of rheumatologists versus nephrologists to LUPKYNIS's 2026 growth and whether ACR guidance-driven prescribing has reached a steady state. He also inquired about the anti-drug antibody (ADA) situation for aritinercept observed in healthy volunteers.

Answer

President and CEO Peter Greenleaf indicated that while the business is split between rheumatology and nephrology, it slightly favors rheumatologists, a trend that has been increasing. He emphasized that ACR guidelines promote earlier diagnosis and aggressive treatment, which is still not fully adopted. Chief Medical Officer Dr. Greg Keenan confirmed that low titers of anti-drug antibodies (ADAs) were seen at 25 mg and above for aritinercept, but without impact on injection site reactions or pharmacokinetic/pharmacodynamic profiles, expressing confidence in the molecule.

Arthur He asked if Aurinia plans to present detailed data from the Aratinacept SAD study at an upcoming medical conference. He also pressed for clarity on the conditions under which the company would disclose the specific indications it is pursuing for the drug.

Answer

CMO Dr. Greg Keenan confirmed the data will be presented at a future medical meeting, but the specific conference has not yet been determined. CEO Peter Greenleaf explained that while the information will become public when trials are registered on clinicaltrials.gov, the company is currently withholding details for competitive reasons and has not decided on an earlier disclosure timeline.

Arthur He from H.C. Wainwright inquired about the potential design of a maintenance phase for the alopecia areata (AA) study, should the current Phase IIb trial prove successful. He also asked for a technical clarification on the follow-up period for patients receiving extended treatment.

Answer

Executive Jonathan Zalevsky explained that a future Phase III AA study would likely mirror the atopic dermatitis approach, with a higher-frequency induction period followed by a lower-frequency maintenance regimen. He clarified that all patients in the current study, including those with treatment extensions, have a 24-week off-drug follow-up period.

Arthur He from H.C. Wainwright & Co. asked for clarification on the atopic dermatitis study design, specifically whether patients could receive continuous treatment during the 52-week follow-up period.

Answer

Chief R&D Officer Dr. Jonathan Zalevsky clarified that after the 52-week treatment period (16-week induction plus 36-week maintenance), patients will be followed for an additional 52 weeks with no further treatment. He stated the objective is to assess the potential remittive effect of REZPEG one year after therapy has concluded.

Arthur He asked about the real-world screening rates for MAGE-A4 and HLA compared to previous guidance and questioned the reason for lete-cel's longer duration of response (DoR) in synovial sarcoma versus afami-cel (Tecelra).

Answer

CEO Adrian Rawcliffe explained it's too early to confirm real-world screening rates but sees no reason to deviate from estimates derived from large clinical trial populations. Regarding the DoR, he and executive Dennis Williams noted the data is still maturing and that median DoR can be volatile with small patient numbers. They emphasized that both therapies show impressive durability and comparing across different trials and subpopulations is complex.

Arthur He requested more specific details on the study initiation timeline for the randomized HB-200 trial and when initial data might be expected, and also asked for more information on the company's upcoming AACR presentation.

Answer

CEO Joern Aldag explained that the decision to initiate the randomized HB-200 trial is contingent on the Q2 data readout, after which more specific timelines will be provided. Chief Medical Officer Katia Schlienger confirmed that logistical preparations are complete. Regarding the AACR presentation, Mr. Aldag detailed that it will feature preclinical data on combining HB-200 with IL-2 to demonstrate enhanced therapeutic effects by driving T cells to the tumor.

Arthur He of H.C. Wainwright & Co. asked about iTeos' confidence in its adenosine antagonist for castrate-resistant prostate cancer (CRPC) as a monotherapy or doublet, given competitors' focus on triplet combinations. He also inquired about expectations for the next pipeline candidate from the adenosine pathway.

Answer

President and CEO Michel Detheux explained that the monotherapy approach in CRPC helps to understand the mechanism and identify patient populations, while the doublet combination with pembrolizumab offers a differentiating chemo-free regimen. He also confirmed that the research team has identified a new target in the adenosine pathway and plans to nominate a clinical candidate by the end of the year.