Aktis Oncology, Inc. reported financial results for the third quarter ended September 30, 2026, and provided an update on its clinical development pipeline. The company announced the initiation of its third Phase 1b clinical trial, BActinium-2, which is evaluating AKY-2519 in patients with non-small cell lung cancer and other B7-H3 expressing solid tumors.
Regarding its two primary clinical-stage programs, Aktis is advancing AKY-1189 and AKY-2519. AKY-1189 is a miniprotein radioconjugate targeting Nectin-4, and dose escalation is ongoing in the Phase 1b NECTINIUM-2 trial. The company initiated backfill at the 6 MBq dose level to further characterize safety and preliminary antitumor activity in up to 30 patients. AKY-2519 is a miniprotein radioconjugate targeting B7-H3, and dose escalation is ongoing in the Phase 1b BActinium-1 trial for metastatic castration-resistant prostate cancer. In this trial, Aktis initiated backfill at the 9 MBq dose level for both PLUVICTO-naïve and PLUVICTO-experienced cohorts.
On the financial front, Aktis Oncology reported cash, cash equivalents, and marketable securities of $492.9 million as of September 30, 2026. The company stated that this cash position is expected to fund its operating plan into 2029. For the quarter, collaboration revenue was $3.9 million, while research and development expenses were $32.1 million, and general and administrative expenses were $6.5 million. The company reported a net loss of $29.9 million for the quarter.
Aktis also provided an update on its manufacturing capabilities. The company began manufacturing drug product in its in-house GMP facility at 17 Drydock in Boston and intends to amend the INDs for AKY-2519 and AKY-1189 to include this facility as a manufacturer of clinical supply. The company anticipates preliminary data from the Phase 1b NECTINIUM-2 trial in the first quarter of 2027 and preliminary data from the Phase 1b BActinium-1 trial in 2027.
