AKTS 8-K
Aktis Oncology, Inc. (AKTS)
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM
CURRENT REPORT
Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934
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Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:
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Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) |
Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c)) |
Securities registered pursuant to Section 12(b) of the Act:
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Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).
Emerging growth company
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act.
Item 2.02. |
Results of Operations and Financial Condition |
On August 13, 2026, Aktis Oncology, Inc. issued a press release announcing its financial results and business highlights for the quarter ended June 30, 2026. A copy of the press release is furnished as Exhibit 99.1 to this Current Report on Form 8-K.
The information contained in Item 2.02 of this Current Report on Form 8-K (including Exhibit 99.1 hereto) shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities of that section, nor shall it be deemed incorporated by reference in any filing under the Securities Act of 1933, as amended, or the Exchange Act, except as expressly provided by specific reference in such a filing.
Item 9.01. |
Financial Statements and Exhibits. |
(d) Exhibits.
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Exhibit |
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Description |
99.1* |
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104 |
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Cover Page Interactive Data File (embedded within the Inline XBRL document). |
* Furnished herewith
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
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AKTIS ONCOLOGY, INC. |
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Date: August 13, 2026 |
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By: |
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/s/ Kyle Kuvalanka |
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Kyle Kuvalanka |
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Chief Financial Officer |
Aktis Oncology Reports Financial Results and Business Highlights for the Second Quarter 2026
BOSTON, August 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 (225Ac) to tumors expressing Nectin-4, a clinically and commercially validated target expressed in several tumor types, including urothelial and breast.
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.
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Anticipated milestones for the next 12 months
Second quarter 2026 financial results
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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 www.aktisoncology.com.
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
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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)
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Three Months Ended June 30, |
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Six Months Ended June 30, |
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2026 |
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2025 |
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2026 |
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2025 |
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Revenue: |
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Collaboration revenue |
$ |
3,384 |
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$ |
1,601 |
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$ |
6,611 |
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$ |
3,048 |
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Operating expenses: |
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Research and development |
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25,280 |
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18,628 |
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45,316 |
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34,491 |
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General and administrative |
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7,003 |
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3,936 |
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12,900 |
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7,663 |
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Total operating expenses |
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32,283 |
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22,564 |
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58,216 |
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42,154 |
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Loss from operations |
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(28,899 |
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(20,963 |
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(51,605 |
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(39,106 |
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Other income (expense): |
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Interest income |
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4,765 |
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2,908 |
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9,149 |
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6,079 |
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Other expense, net |
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(10 |
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(20 |
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(13 |
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(33 |
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Total other income, net |
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4,755 |
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2,888 |
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9,136 |
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6,046 |
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Net loss |
$ |
(24,144 |
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$ |
(18,075 |
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$ |
(42,469 |
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$ |
(33,060 |
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AKTIS ONCOLOGY, INC.
BALANCE SHEET DATA
(In thousands)
(Unaudited)
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June 30, |
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December 31, |
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2026 |
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2025 |
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Cash, cash equivalents, and marketable securities |
$ |
517,320 |
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$ |
226,787 |
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Total assets |
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557,596 |
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264,885 |
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Total liabilities |
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72,758 |
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77,625 |
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Total stockholders' equity and redeemable convertible preferred stock |
$ |
484,838 |
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$ |
187,260 |
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Media contact:
Melone Communications, LLC
Liz Melone
617-256-6622
Investor contact:
Precision AQ
Alex Lobo
212-698-8802
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