On August 13, 2026 Aktis Oncology, Inc. (NASDAQ:AKTS) ("Aktis" or the "Company"), a clinical-stage oncology company focused on expanding the breakthrough potential of targeted radiopharmaceuticals to large populations, including those not addressed by existing platform technologies, reported financial results and business highlights for the second quarter ended June 30, 2026.
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"This was a quarter of strong execution for Aktis, focused on generating clinical data and building infrastructure to support our clinical pipeline," said Matthew Roden, Ph.D., President and Chief Executive Officer of Aktis Oncology. "Our AKY-2519 clinical imaging and dosimetry data presented at ASCO (Free ASCO Whitepaper) generated significant enthusiasm among clinical investigators, helping to advance enrollment in the ongoing Phase 1b trials of AKY-1189 and AKY-2519, and setting the stage for a data-rich 2027."
Dr. Roden added, "In the second half of 2026, we expect to initiate the Phase 1b trial with AKY-2519 in B7-H3 expressing solid tumors, representing our third Phase 1b trial. We also expect to continue operationalizing our internal GMP facility as part of our comprehensive strategy to enable our own clinical supply for our pipeline. We believe that the breadth of our pipeline, together with our proprietary miniprotein radioconjugate platform and reliable end-to-end supply chain, position us for leadership in targeted radiopharmaceuticals."
Second quarter 2026 and recent business highlights
AKY-1189 highlights
AKY-1189 is a novel, clinical-stage miniprotein radioconjugate designed to selectively deliver actinium-225 (225Ac) to tumors expressing Nectin-4, a clinically and commercially validated target expressed in several tumor types, including urothelial and breast.
Continued to enroll patients in ongoing Phase 1b, multicenter, open-label NECTINIUM-2 clinical trial of AKY-1189 in patients with locally advanced or mUC, breast cancer, and other Nectin-4 expressing solid tumors.
AKY-2519 highlights
AKY-2519 is a novel, clinical-stage miniprotein radioconjugate designed to selectively deliver 225Ac to tumors expressing B7-H3, a clinically validated target expressed in prostate, lung, and other solid tumor cancers.
Presented first-in-human clinical imaging and dosimetry data for AKY-2519 across several B7-H3 expressing tumor types, including mCRPC, at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting in May 2026.
Data demonstrated robust tumor uptake and retention of AKY-2519 with limited normal tissue exposure, suggesting the potential for a wide therapeutic window and differentiated profile compared to approved radiopharmaceuticals.
Imaging and dosimetry with AKY-2519 were generally well tolerated, with no reported adverse events or infusion-related reactions. For more information, read the press release here.
Enrolling patients in Phase 1b, multicenter, open-label BActinium-1 clinical trial of AKY-2519 in PLUVICTO-naïve and -experienced patients with mCRPC.
Cleared regulatory review to initiate Phase 1b, multicenter, open-label BActinium-2 clinical trial of AKY-2519 in patients with various other B7-H3 expressing tumors.
Anticipated milestones for the next 12 months
AKY-1189:
Expect preliminary data from the ongoing Phase 1b NECTINIUM-2 clinical trial in the first quarter of 2027.
AKY-2519:
Expect to commence Phase 1b BActinium-2 basket trial in lung and other B7-H3 expressing solid tumor cancers in the second half of 2026.
Expect preliminary data from Phase 1b mCRPC clinical trial in 2027.
Early pipeline:
Two programs tracking toward development candidate nomination and commencement of IND-enabling activities in the first quarter of 2027.
Corporate:
In-house Good Manufacturing Practices (GMP) facility expected to be operational in the second half of 2026 as part of the Company’s hybrid manufacturing strategy to expand capabilities and support clinical supply demand.
Second quarter 2026 financial results
Cash position: Cash, cash equivalents, and marketable securities were $517.3 million as of June 30, 2026, compared to $226.8 million as of December 31, 2025. The increase in cash, cash equivalents, and marketable securities reflects net proceeds from the Company’s initial public offering in January 2026, primarily offset by cash used in operations. The Company’s cash, cash equivalents, and marketable securities as of June 30, 2026, are expected to fund the Company’s operating plan into 2029.
Collaboration revenue: Collaboration revenue was $3.4 million for the quarter ended June 30, 2026, compared to $1.6 million for the comparable prior-year period. The increase of $1.8 million was attributable to continued advancement of the Company’s research collaboration with Eli Lilly and Company, with revenue recognized over time using the cost incurred input method.
R&D expenses: Research and development expenses were $25.3 million for the quarter ended June 30, 2026, compared to $18.6 million for the comparable prior-year period. The increase of $6.7 million was primarily driven by ongoing operations of the Company’s Phase 1b clinical trial for AKY-1189 and the IND-enabling studies and initiation of clinical trials for AKY-2519.
G&A expenses: General and administrative expenses were $7.0 million for the quarter ended June 30, 2026, compared to $3.9 million for the comparable prior-year period. The increase of $3.1 million was primarily due to higher employee-related costs (including stock-based compensation) associated with increased hiring to support the Company’s growth, as well as increased expenses related to operating as a public company.
Net loss: Net loss was $24.1 million for the quarter ended June 30, 2026, compared to $18.1 million for the comparable prior-year period. The increase in net loss of $6.0 million was primarily driven by higher operating expenses offset by interest income, net of $4.8 million in the quarter.
About Aktis’ miniprotein radioconjugate platform
Aktis has developed a proprietary, isotope-agnostic miniprotein radioconjugate platform to selectively deliver the tumor-killing properties of radioisotopes to targeted tumors. Aktis’ therapeutic miniprotein radioconjugates are designed to maximize anticancer activity through high tumor penetration coupled with internalization and retention in cancer cells, while rapidly clearing from normal organs and tissues. The Aktis platform further enables clinicians to visualize and verify target engagement with imaging isotopes prior to exposure to therapeutic radioisotopes. Leveraging this platform, and its patient-first end-to-end clinical supply chain built for resiliency and scalability, Aktis is advancing a pipeline of next-generation targeted radiopharmaceuticals to address the unmet needs of patients across a broad spectrum of solid tumors.
(Press release, Aktis Oncology, AUG 13, 2026, View Source [SID1234670080])