Arseniy Shabashvili

Arseniy Shabashvili from Guggenheim Partners asked about the upcoming preclinical milestones for oncology programs ABS-301 and ABS-501, their path to IND-enabling studies, and the rationale for prioritizing the alopecia indication for ABS-201 over endometriosis.

Answer

CFO Zach Jonasson stated that the next step for the oncology programs is completing in vivo work for a development candidate package, after which they will be partnered. CEO Sean McClain added that Absci's internal focus is on I&I. Regarding ABS-201, McClain explained that the Phase 1/2a trial is designed to include female patients, preserving the option to pursue a Phase 2 trial in endometriosis in parallel to the alopecia program.

Arseniy Shabashvili from Guggenheim Partners asked about the next preclinical milestones for oncology programs ABS-301 and ABS-501, and the company's latest thinking on prioritizing endometriosis for ABS-201.

Answer

CFO & CBO Zach Jonasson explained that the next step for the oncology programs is completing in vivo work for a development candidate package, after which they will be partnered. CEO Sean McClain added that for ABS-201, the Phase 1/2a trial will include female patients to preserve the option of pursuing an endometriosis indication in the future.

Arseniy Shabashvili of Guggenheim Securities inquired about the expected outcomes for the ABS-101 Phase I trial data, specifically focusing on pharmacokinetics (PK) and immunogenicity, and asked about the potential for self-administration of ABS-201.

Answer

CEO Sean McClain and SVP of Drug Creation Christian Stegmann responded. For ABS-101, they are looking for a strong safety profile, low immunogenicity, and target engagement data similar to previous NHP studies. Stegmann added they aim to validate the extended half-life to support dosing every 8-12 weeks. Regarding ABS-201, McClain stated that while it could eventually be self-administered, the initial plan is to work with dermatologists.

Arseniy Shabashvili of Guggenheim Securities asked about the medical community's reception to new data from the SPARTAN studies and whether further real-world or biomarker data is anticipated to support Filspari's positioning as a disease-modifying therapy.

Answer

Dr. Jula Inrig, Chief Medical Officer, reported a very positive reception, with excitement around data showing Filspari's efficacy in combination with SGLT2 inhibitors and its effect on disease-modifying biomarkers. She confirmed plans to validate these findings using the large Phase 3 study biomarker set and present that data at future congresses.

In a follow-up, Arseniy Shabashvili of Guggenheim Securities asked about FILSPARI's uptake among community-based nephrologists versus academic thought leaders, and whether the message is reaching a broader physician base post-full approval.

Answer

Chief Commercial Officer Peter Heerma responded that while it's still early post-full approval, the commercial strategy targets a broad base of ~6,000 nephrologists to reach the majority of patients, who reside in the community. He confirmed that prescription patterns show the majority of uptake is from community physicians, while also noting strong, positive feedback from academic leaders, especially with the support of the new KDIGO guidelines.