SERP-01

Sept. 15, 2026: Serapha Bio announced senior leadership appointments, including Kenneth T. Mills as CEO and board member, Daphne Karydas as President/CFO, Weston Miller, MD, as CMO, Nina Hunter, PhD, as Chief Development Officer, and Shiva G. Fritsch as Chief Corporate Affairs Officer.

For its lead program SERP-01, an investigational in vivo base-editing therapy for alpha-1 antitrypsin deficiency (AATD) in PiZZ patients, Serapha said the FDA has cleared the IND for a Phase 2/3 trial and granted orphan drug and RMAT designations. The company plans to initiate the Phase 2/3 study in late 2026 or early 2027.

Serapha also said positive proof-of-concept data from an ongoing investigator-initiated trial were presented earlier in September at the European Respiratory Society Congress. According to the presentation, a single treatment produced dose-dependent increases in AAT levels above the protective threshold sustained through cutoff, substantial reductions in Z-AAT protein, and direct correction of the target mutation, with no bystander or off-target editing detected by the assays used.

Separately, Serapha said its previously announced merger with Boundless Bio (NASDAQ: BOLD) remains expected to close in Q4 2026, subject to customary conditions and stockholder approval. It has secured about $230 million in pre-closing private investment commitments; after closing, the combined company plans to operate as Serapha Bio and seek to trade on Nasdaq under “AATD.”