Lutetium (177 Lu) Vipivotide Tetraxetan

Presented first-in-human clinical imaging and dosimetry data for AKY-2519, supporting a broad clinical development program in patients with prostate, lung, and other B7-H3 expressing solid tumors Enrolling patients in Phase 1b trial of AKY-1189 in locally advanced or metastatic urothelial cancer (mUC) and other Nectin-4 expressing solid tumors Initiated Phase 1b trial of AKY-2519 in metastatic castration-resistant prostate cancer (mCRPC) On track to initiate Phase 1b trial of AKY-2519 in other B7-H3 expressing solid tumors, including lung cancers, in the second half of 2026 BOSTON, Aug. 13, 2026 (GLOBE NEWSWIRE) -- 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, today reported financial results and business highlights for the second quarter ended June 30, 2026. “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 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 ( 225 Ac) 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 225 Ac 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) 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 pro 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. About Aktis Oncology Aktis Oncology, Inc. is a clinical-stage oncology company focused on expanding the breakthrough potential of targeted radiopharmaceuticals to large patient populations, including those not addressed by existing platform technologies. Aktis’ most advanced clinical-stage pipeline program, AKY-1189, is a miniprotein radioconjugate targeting Nectin-4, with multi-indication potential across multiple tumor types, including locally advanced or metastatic urothelial cancer, breast cancer, and other solid tumor cancers. Aktis’ second clinical-stage pipeline program, AKY-2519, is a miniprotein radioconjugate targeting B7-H3 expressing tumors, including prostate, lung, and other solid tumors. Aktis has a discovery collaboration with Eli Lilly and Company to leverage Aktis’ miniprotein platform to develop novel radioconjugates outside of its proprietary pipeline. For more information, please visit . Forward-looking statements This press release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended, including statements regarding the Company’s expectations about the timing of ongoing and planned clinical trials and regulatory filings, goals to develop and commercialize its product candidates, its liquidity and capital resources, and other statements identified by words such as “could,” “expects,” “intends,” “may,” “plans,” “potential,” “should,” “will,” “would,” or similar expressions and the negatives of those terms. Forward-looking statements are not promises or guarantees of future performance, and are subject to a variety of risks and uncertainties, many of which are beyond the Company’s control, and which could cause actual results to differ materially from those contemplated in such forward-looking statements. These factors include risks related to the commencement and completion of the Company’s ongoing and planned clinical trials, the Company’s limited operating history, its ability to generate positive clinical trial results for its product candidates and other risks inherent in clinical development, the timing and scope of regulatory approvals, changes in laws and regulations to which the Company is subject, competitive pressures, risks relating to business interruptions, and other risks set forth under the heading “Risk Factors” of the Company’s Annual Report on Form 10-K for the year ended December 31, 2025, and in subsequent filings with the Securities and Exchange Commission. The Company’s actual results could differ materially from the results described in or implied by such forward-looking statements. Forward-looking statements speak only as of the date hereof, and, except as required by law, the Company undertakes no obligation to update or revise these forward-looking statements. AKTIS ONCOLOGY, INC. CONDENSED CONSOLIDATED STATEMENT OF OPERATIONS (In thousands) (Unaudited) Three Months Ended June 30, Six Months Ended June 30, 2026 2025 2026 2025 Revenue: Collaboration revenue $ 3,384 $ 1,601 $ 6,611 $ 3,048 Operating expenses: Research and development 25,280 18,628 45,316 34,491 General and administrative 7,003 3,936 12,900 7,663 Total operating expenses 32,283 22,564 58,216 42,154 Loss from operations (28,899 ) (20,963 ) (51,605 ) (39,106 ) Other income (expense): Interest income 4,765 2,908 9,149 6,079 Other expense, net (10 ) (20 ) (13 ) (33 ) Total other income, net 4,755 2,888 9,136 6,046 Net loss $ (24,144 ) $ (18,075 ) $ (42,469 ) $ (33,060 ) AKTIS ONCOLOGY, INC. BALANCE SHEET DATA (In thousands) (Unaudited) June 30, December 31, 2026 2025 Cash, cash equivalents, and marketable securities $ 517,320 $ 226,787 Total assets 557,596 264,885 Total liabilities 72,758 77,625 Total stockholders' equity and redeemable convertible preferred stock $ 484,838 $ 187,260 Media contact: Melone Communications, LLC Liz Melone 617-256-6622 liz@melonecomm.com Investor contact: Precision AQ Alex Lobo 212-698-8802 Alex.lobo@precisionaq.com

The FDA has denied ITM Isotopes Technologies’ lead pipeline candidate for a rare group of tumors due to qualms over the drug’s manufacturing. The FDA’s complete response letter did not raise any issues with ITM-11’s clinical or safety data, ITM clarified. Rather, the problems lie with its chemistry, manufacturing and controls and with a third-party commercial facility. ITM’s application rested on data from the phase 3 Compete trial in patients with gastroenteropancreatic neuroendocrine tumors (GEP-NETs). These malignancies arise in a specialized group of neurons that secrete hormones, called neuroendocrine cells. The German radiopharma, long an isotope supplier for others in the industry, previously shared that ITM-11 bested Novartis’ Afinitor at prolonging progression-free survival in the study, but did not show a statistically significant benefit in median overall survival. “Our confidence in ITM-11’s therapeutic potential has not wavered, and we are committed to working closely with the FDA and our partners to address the items outlined in the CRL,” Andrew Cavey, M.D., ITM’s chief exec, said in the company’s release. “Our pivotal Compete trial data package stands, and our goal remains unchanged as we work toward bringing ITM-11 to patients living with advanced GEP-NETs.” The radiopharma is committed to resubmitting ITM-11’s new drug application, according to the release. ITM-11 contains a radioactive form of lutetium called lutetium-177, the same isotope that ITM supplies for Novartis’ blockbuster prostate cancer therapy Pluvicto. The Swiss pharma giant markets a rival neuroendocrine tumors therapy, Lutathera, which also uses lutetium-177. ITM is also testing ITM-11 in a slew of other trials, including a phase 3 study for a different subset of patients with GEP-NETs. Another phase 3 trial is running in patients with lung and thymus neuroendocrine tumors, and ITM-11 is also being tested in a phase 1 pediatric trial in SSTR-positive tumors. ITM’s pipeline also includes 10 other named assets, all in preclinical or phase 1 stages of development.