On November 12, 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, reported financial results for the third quarter ended September 30, 2026, and provided a business update, including progress with the Company’s two clinical-stage programs.

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"Aktis is on a trajectory to redefine radiopharmaceuticals as a major pillar of cancer treatment by expanding the modality to more targets, broader indications, and larger patient populations. In the third quarter, we continued to make tremendous progress operationalizing this vision," said Matthew Roden, Ph.D., President and Chief Executive Officer at Aktis Oncology. "With the initiation of the BActinium-2 trial of AKY-2519, we now have three clinical trials underway in the U.S. across two novel targets, Nectin-4 and B7-H3, which are both implicated in a range of solid tumor types. We also opened the first backfill cohorts in our ongoing NECTINIUM-2 and BActinium-1 trials to further characterize safety and preliminary antitumor activity at the selected doses, while dose escalation continues in both studies. This substantial clinical progress is a testament to our ability to execute rapidly with quality across multiple clinical trials and positions Aktis for a data-rich 2027."

Third quarter 2026 and recent business highlights

AKY-1189

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 locally advanced or metastatic urothelial cancer (mUC) and breast cancer.

Dose escalation is ongoing in the Phase 1b NECTINIUM-2 trial evaluating AKY-1189 in patients with locally advanced or mUC and other Nectin-4 expressing solid tumors.
Aktis initiated backfill at the 6 MBq dose level to further characterize safety and preliminary antitumor activity in up to 30 patients. This is the first of up to two dose levels planned to be selected for backfill.
AKY-2519

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 tumors.

Aktis initiated the Phase 1b BActinium-2 trial evaluating AKY-2519 in patients with non-small cell lung cancer (NSCLC) and other B7-H3 expressing solid tumors.
Dose escalation is ongoing in the Phase 1b BActinium-1 trial evaluating AKY-2519 in patients with metastatic castration-resistant prostate cancer (mCRPC), including PLUVICTO-naïve and PLUVICTO-experienced patients.
In the Phase 1b BActinium-1 trial, Aktis initiated backfill at the 9 MBq dose level for both the PLUVICTO-naïve and PLUVICTO-experienced cohorts to further characterize safety and preliminary antitumor activity in up to 30 patients per cohort. This is the first of up to two planned dose levels that will be backfilled in each of the mCRPC patient populations.
Dr. Roden added, "With our robust end-to-end supply chain supported by multiple contract manufacturing organizations and isotope suppliers, we are successfully delivering clinical supply for our clinical trials nationally. In the quarter, we operationalized our in-house GMP facility at 17 Drydock in Boston, where we expect to begin supplying drug product for our clinical trials in the first half of 2027, further expanding manufacturing capacity for clinical supply. The 17 Drydock facility progresses our strategy to build capabilities to support potential Phase 3 trials and commercial product supply in a capital-efficient manner."

Manufacturing

Aktis began manufacturing drug product in its in-house GMP facility, as part of the Company’s hybrid sourcing manufacturing strategy. Aktis intends to amend the INDs for AKY-2519 and AKY-1189 to include the in-house facility as a manufacturer of clinical supply for its ongoing clinical trials.
Anticipated milestones for the next 12 months

AKY-1189: Expect preliminary data from the ongoing Phase 1b NECTINIUM-2 trial in the first quarter of 2027.
AKY-2519: Expect preliminary data from the ongoing Phase 1b BActinium-1 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: Expect to expand drug supply to include our in-house GMP facility to support ongoing clinical trials in the first half of 2027.
Third quarter 2026 financial results

Cash position: Cash, cash equivalents, and marketable securities were $492.9 million as of September 30, 2026, compared with $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 September 30, 2026, are expected to fund the Company’s operating plan into 2029.
Collaboration revenue: Collaboration revenue was $3.9 million for the quarter ended September 30, 2026, compared with $1.6 million for the comparable prior-year period. The increase of $2.3 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 $32.1 million for the quarter ended September 30, 2026, compared with $16.5 million for the comparable prior-year period. The increase of $15.6 million was primarily driven by the advancement of clinical trials for AKY-1189 and AKY-2519 and increased headcount primarily in clinical development and manufacturing to support the advancement of the clinical pipeline.
G&A expenses: General and administrative expenses were $6.5 million for the quarter ended September 30, 2026, compared with $3.3 million for the comparable prior-year period. The increase of $3.2 million was primarily due to increased headcount to support company growth and increased activities associated with operating as a public company.
Net loss: Net loss was $29.9 million for the quarter ended September 30, 2026, compared with $15.5 million for the comparable prior-year period. The increase of $14.4 million was primarily driven by higher operating expenses, partially offset by increased collaboration revenue recognized and interest income, net.
PLUVICTO (lutetium Lu 177 vipivotide tetraxetan) is a registered trademark of Novartis Pharmaceuticals Corporation.

About NECTINIUM-2
The Phase 1b multicenter, open-label clinical trial is evaluating AKY-1189 in patients with locally advanced or mUC, breast cancer and other Nectin-4 expressing tumors. The trial will explore up to 5 dose levels in the dose escalation. Per protocol, Aktis has the ability to expand enrollment in backfill cohorts at selected dose levels and tumor types to generate additional clinical data while dose escalation continues. The trial is being conducted in the U.S. Additional information about the trial is available at clinicaltrials.gov using the identifier NCT07020117.

About BActinium-1
The Phase 1b multicenter, open-label clinical trial is evaluating AKY-2519 in patients with mCRPC, including PLUVICTO-naïve and PLUVICTO-experienced cohorts. The study will explore up to 3 dose levels in the dose escalation. Per protocol, Aktis has the ability to expand enrollment in backfill cohorts at selected dose levels to generate additional clinical data while dose escalation continues. The trial is being conducted in the U.S. Additional information about the trial is available at clinicaltrials.gov using the identifier NCT07581184.

About BActinium-2
The Phase 1b multicenter, open-label trial is evaluating AKY-2519 in patients with NSCLC and other B7-H3 expressing solid tumors. The study will explore up to 3 dose levels in the dose escalation. Per protocol, Aktis has the ability to expand enrollment at selected dose levels and tumor types to generate additional clinical data while dose escalation continues. The trial is being conducted in the U.S. Additional information about the trial is available at clinicaltrials.gov using the identifier NCT07887971.

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, NOV 12, 2026, View Source [SID1234674700])