AKTS
Aktis OncologyADocument history
Earnings documents stored for AKTS.
Investor releaseQuarter not tagged2026-08-13Aktis Oncology Reports Financial Results and Business Highlights for the Second Quarter 2026
GlobeNewswire
Aktis Oncology Reports Financial Results and Business Highlights for the Second Quarter 2026
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 (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 ongoi…Read full documentShow less
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 (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) Annual Meeting in May 2026. 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: AKY-2519: Early pipeline: Corporate: 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 platformAktis 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 OncologyAktis 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 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. Media contact:Melone Communications, LLCLiz [email protected] Investor contact:Precision AQAlex [email protected]
Investor releaseQuarter not tagged2026-08-13Aktis: Q2 Earnings Snapshot
Associated Press
Aktis: Q2 Earnings Snapshot
BOSTON (AP) — BOSTON (AP) — Aktis Oncology Inc. (AKTS) on Thursday reported a loss of $24.1 million in its second quarter. The Boston-based company said it had a loss of 44 cents per share. The results met Wall Street expectations. The average estimate of five analysts surveyed by Zacks Investment Research was also for a loss of 44 cents per share. The clinical-stage oncology company posted revenue of $3.4 million in the period, which beat Street forecasts. Three analysts surveyed by Zacks expected $2.3 million. _____ This story was generated by Automated Insights (http://automatedinsights.com/ap) using data from Zacks Investment Research. Access a Zacks stock report on AKTS at https://www.zacks.com/ap/AKTS
Investor releaseQuarter not tagged2026-05-12Aktis Oncology Reports Financial Results and Business Highlights for First Quarter 2026
GlobeNewswire
Aktis Oncology Reports Financial Results and Business Highlights for First Quarter 2026
Announced two-trial clinical development strategy for AKY-2519 enabling evaluation in multiple patient segments Initiated Phase 1b clinical trial of AKY-2519 in metastatic castration-resistant prostate cancer (mCRPC); expect preliminary data in 2027 Announced AKY-2519 clinical imaging and dosimetry data presentation at upcoming 2026 ASCO Annual Meeting Enrolling patients with Nectin-4 expressing tumors in ongoing Phase 1b clinical trial of AKY-1189; expect preliminary data in first quarter 2027 BOSTON, May 11, 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 first quarter ended March 31, 2026. "We continue to build momentum toward delivering a new class of radiopharmaceuticals targeting tumor types with large patient populations, leveraging our differentiated miniprotein radioconjugate platform and patient-first end-to-end supply chain,” said Matthew Roden, Ph.D., President and Chief Executive Officer of Aktis Oncology. “Last week, we announced the initiation of our Phase 1b clinical trial of AKY-2519 in patients with mCRPC. This is the first of two trials in our clinical development strategy designed to expand the breadth of tumors studied and augment speed to data, with preliminary data from the mCRPC trial anticipated in 2027. We plan to initiate a second Phase 1b basket trial of AKY-2519 in additional solid tumors in the second half of this year. We also look forward to presenting our first AKY-2519 clinical imaging and dosimetry data for AKY-2519 at ASCO, which informed our clinical development strategy.” Dr. Roden continued, “AKY-2519 marks the second program we have advanced from our proprietary miniprotein radioconjugate platform to the clinic in the last twelve months. In parallel, we continue to enroll patients in our ongoing Phase 1b trial of AKY-1189 targeting Nectin-4 expressing tumors, with preliminary data expected in the first quarter of 2027. We remain focused on generating clinical data intended to support advancement of both programs and maximizing the potential clinical benefit for patients.” Q1 and recent business highlights AKY-1189 highlig…Read full documentShow less
Announced two-trial clinical development strategy for AKY-2519 enabling evaluation in multiple patient segments Initiated Phase 1b clinical trial of AKY-2519 in metastatic castration-resistant prostate cancer (mCRPC); expect preliminary data in 2027 Announced AKY-2519 clinical imaging and dosimetry data presentation at upcoming 2026 ASCO Annual Meeting Enrolling patients with Nectin-4 expressing tumors in ongoing Phase 1b clinical trial of AKY-1189; expect preliminary data in first quarter 2027 BOSTON, May 11, 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 first quarter ended March 31, 2026. "We continue to build momentum toward delivering a new class of radiopharmaceuticals targeting tumor types with large patient populations, leveraging our differentiated miniprotein radioconjugate platform and patient-first end-to-end supply chain,” said Matthew Roden, Ph.D., President and Chief Executive Officer of Aktis Oncology. “Last week, we announced the initiation of our Phase 1b clinical trial of AKY-2519 in patients with mCRPC. This is the first of two trials in our clinical development strategy designed to expand the breadth of tumors studied and augment speed to data, with preliminary data from the mCRPC trial anticipated in 2027. We plan to initiate a second Phase 1b basket trial of AKY-2519 in additional solid tumors in the second half of this year. We also look forward to presenting our first AKY-2519 clinical imaging and dosimetry data for AKY-2519 at ASCO, which informed our clinical development strategy.” Dr. Roden continued, “AKY-2519 marks the second program we have advanced from our proprietary miniprotein radioconjugate platform to the clinic in the last twelve months. In parallel, we continue to enroll patients in our ongoing Phase 1b trial of AKY-1189 targeting Nectin-4 expressing tumors, with preliminary data expected in the first quarter of 2027. We remain focused on generating clinical data intended to support advancement of both programs and maximizing the potential clinical benefit for patients.” Q1 and recent business highlights AKY-1189 highlights AKY-1189 is a novel, clinical-stage miniprotein radioconjugate designed to selectively deliver actinium-225 (225Ac) to Nectin-4 expressing tumors. Received Fast Track designation from the U.S. Food and Drug Administration (FDA) for AKY-1189 for the treatment of adult patients with locally advanced or metastatic urothelial cancer (mUC) who have progressed on or after prior systemic therapies. Enrolling patients in the ongoing Phase 1b clinical trial of AKY-1189 in patients with locally advanced or mUC, breast cancer, non-small cell lung cancer, colorectal cancer, cervical cancer, and head and neck cancer. Expect to report preliminary data from the Phase 1b trial in the first quarter of 2027. AKY-2519 highlights AKY-2519 is a novel, clinical-stage miniprotein radioconjugate designed to selectively deliver 225Ac to B7-H3 expressing tumors, including prostate, lung, and other solid tumors. Received FDA clearance for the Company’s Investigational New Drug (IND) applications to proceed to a Phase 1b clinical trial with AKY-25191. Announced two-trial clinical development strategy for AKY-2519, which was informed by insights from the Company’s clinical advisory boards and reflects the distinct treatment patterns and clinical needs of patients with mCRPC compared to other solid tumor patients. This strategy is designed to enable the broad evaluation of AKY-2519 in multiple patient segments while efficiently generating indication-relevant data. Initiated Phase 1b, multicenter, open label clinical trial of AKY-2519 in PLUVICTO®-naïve and PLUVICTO-experienced patients with mCRPC. Plan to initiate a Phase 1b basket trial in patients with lung, colorectal, and other B7-H3 expressing solid tumors in the second half of 2026. The protocol for this trial has been finalized and is currently under regulatory review. Announced clinical imaging and dosimetry data for AKY-2519 has been accepted for presentation at the upcoming American Society of Clinical Oncology (ASCO) Annual Meeting being held May 29 – June 2, 2026, in Chicago. The data facilitate initial understanding of AKY-2519 biodistribution and predicted absorbed doses in tumors and normal tissues in patients with B7-H3 expressing solid tumors. 1 IND applications were cleared for [64Cu]Cu-AKY-2519 for imaging and [225Ac]Ac-AKY-2519 for therapeutic use. General corporate highlights Appointed industry veteran Glenn Gormley, MD, PhD as an independent director to the Company’s Board of Directors (Board) and as co-chair of the Board’s newly established Science and Technology Committee. In January 2026, completed an initial public offering of 20,297,500 shares of common stock, including the exercise in full by the underwriters of their option to purchase an additional 2,647,500 shares of common stock, at $18.00 per share, resulting in gross proceeds of approximately $365.4 million, before deducting underwriting discounts and commissions and other offering expenses. Anticipated pipeline and corporate milestones for the next 12 months AKY-1189: Expect preliminary data from the ongoing Phase 1b clinical trial in the first quarter of 2027. AKY-2519: Will present clinical imaging and dosimetry data of AKY-2519 in patients with mCRPC and various solid tumors at the upcoming ASCO Annual Meeting. Expect to commence Phase 1b basket trial in lung, colorectal, and other solid tumor cancers in the second half of 2026. Expect preliminary data from the Phase 1b mCRPC clinical trial in 2027. Early pipeline: Two programs are 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. First quarter 2026 financial results Cash position: Cash, cash equivalents and marketable securities were $538.5 million as of March 31, 2026, compared to $226.8 million as of December 31, 2025. The increase of $311.7 million primarily 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 March 31, 2026 are expected to fund its operations into 2029. Collaboration revenue: Collaboration revenue was $3.2 million for the quarter ended March 31, 2026, compared to $1.4 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 $20.0 million for the quarter ended March 31, 2026, compared to $15.9 million for the comparable prior year period. The increase of $4.1 million was primarily driven by Phase 1b clinical trial expenses for AKY-1189, which initiated in the second quarter of 2025, increased expenses with advancing AKY-2519 through IND-enabling studies, and increased employee-related costs (including stock-based compensation) associated with increased hiring to support the advancing clinical pipeline. G&A expenses: General and administrative expenses were $5.9 million for the quarter ended March 31, 2026, compared to $3.7 million for the comparable prior year period. The increase of $2.2 million was primarily due to higher employee-related costs (including stock-based compensation) related to increased hiring to support the Company’s growth, and increased expenses associated with operating as a public company. Net loss: Net loss was $18.3 million for the quarter ended March 31, 2026, compared to $15.0 million for the comparable prior year period. The increase in net loss of $3.3 million was primarily driven by increased operating expenses. 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 anti-cancer 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 supply chain, 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, non-small cell lung cancer, colorectal cancer, cervical cancer, and head and neck cancer. Aktis’ second clinical-stage pipeline program, AKY-2519, is a miniprotein radioconjugate targeting B7-H3 expressing tumors, including prostate, lung, colorectal, 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 Company’s limited operating history, its ability to obtain necessary funding, 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, its ability to identify additional product candidates, 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. Media contact: Melone Communications, LLC Liz Melone 617-256-6622 [email protected] Investor contact: Precision AQ Alex Lobo 212-698-8802 [email protected]
Investor releaseQuarter not tagged2026-05-12Aktis: Q1 Earnings Snapshot
Associated Press
Aktis: Q1 Earnings Snapshot
BOSTON (AP) — BOSTON (AP) — Aktis Oncology Inc. (AKTS) on Monday reported a loss of $18.3 million in its first quarter. The Boston-based company said it had a loss of 38 cents per share. The results did not meet Wall Street expectations. The average estimate of five analysts surveyed by Zacks Investment Research was for a loss of 31 cents per share. The clinical-stage oncology company posted revenue of $3.2 million in the period, topping Street forecasts. Four analysts surveyed by Zacks expected $2.9 million. _____ This story was generated by Automated Insights (http://automatedinsights.com/ap) using data from Zacks Investment Research. Access a Zacks stock report on AKTS at https://www.zacks.com/ap/AKTS
Investor releaseQuarter not tagged2026-03-31Aktis Oncology Announces FDA Clearance of Investigational New Drug Applications for AKY-2519 and Provides Business Updates and Full Year 2025 Financial Results
GlobeNewswire
Aktis Oncology Announces FDA Clearance of Investigational New Drug Applications for AKY-2519 and Provides Business Updates and Full Year 2025 Financial Results
Progressing vision to expand the reach of targeted radiopharmaceuticals to large patient populations Anticipating multiple milestones in the next 12 months, including initiation of Phase 1b clinical trial of AKY-2519 in mid-2026 BOSTON, March 30, 2026 (GLOBE NEWSWIRE) -- Aktis Oncology, Inc. (NASDAQ:AKTS) (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 announced the U.S. Food and Drug Administration (FDA) cleared the Investigational New Drug (IND) applications for the Company to proceed to a Phase 1b clinical trial with AKY-25191. AKY-2519 is a miniprotein radioconjugate targeting B7-H3, which is expressed in several solid tumor types including prostate and lung cancers, and is the second clinical stage miniprotein radioconjugate discovered using Aktis’ proprietary platform. The Company’s lead miniprotein radioconjugate, AKY-1189, targeting Nectin-4, is currently enrolling patients in a Phase 1b clinical study. Aktis’ miniprotein radioconjugates are designed to selectively deliver actinium-225 (225Ac), a highly potent alpha-emitting radioisotope, to target-expressing tumors. The Company also provided business updates and reported financial results for the year ended December 31, 2025. “Aktis was founded to improve outcomes for cancer patients by pioneering a new class of targeted radiopharmaceuticals for prevalent tumor types that have historically been beyond the reach of this modality,” said Matthew Roden, Ph.D., President and Chief Executive Officer of Aktis Oncology. “We continue to make significant progress on all fronts of our plan, including advancing the enrollment of our Phase 1b clinical trial of AKY-1189 in patients with Nectin-4 expressing tumors, which was granted FDA Fast Track designation in February, as well as the recent clearance of our IND applications for AKY-2519. We are excited to accelerate the AKY-2519 program to patients in need of improved treatment options, and now expect to commence a Phase 1b trial of AKY-2519 in mid-2026. This momentum, together with our proprietary miniprotein radioconjugate platform, supply chain infrastructure, and strong cash position, strengthens our leadership in targeted radiopharmaceuticals.” Dr. Roden continued, “AKY-1189 and AKY…Read full documentShow less
Progressing vision to expand the reach of targeted radiopharmaceuticals to large patient populations Anticipating multiple milestones in the next 12 months, including initiation of Phase 1b clinical trial of AKY-2519 in mid-2026 BOSTON, March 30, 2026 (GLOBE NEWSWIRE) -- Aktis Oncology, Inc. (NASDAQ:AKTS) (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 announced the U.S. Food and Drug Administration (FDA) cleared the Investigational New Drug (IND) applications for the Company to proceed to a Phase 1b clinical trial with AKY-25191. AKY-2519 is a miniprotein radioconjugate targeting B7-H3, which is expressed in several solid tumor types including prostate and lung cancers, and is the second clinical stage miniprotein radioconjugate discovered using Aktis’ proprietary platform. The Company’s lead miniprotein radioconjugate, AKY-1189, targeting Nectin-4, is currently enrolling patients in a Phase 1b clinical study. Aktis’ miniprotein radioconjugates are designed to selectively deliver actinium-225 (225Ac), a highly potent alpha-emitting radioisotope, to target-expressing tumors. The Company also provided business updates and reported financial results for the year ended December 31, 2025. “Aktis was founded to improve outcomes for cancer patients by pioneering a new class of targeted radiopharmaceuticals for prevalent tumor types that have historically been beyond the reach of this modality,” said Matthew Roden, Ph.D., President and Chief Executive Officer of Aktis Oncology. “We continue to make significant progress on all fronts of our plan, including advancing the enrollment of our Phase 1b clinical trial of AKY-1189 in patients with Nectin-4 expressing tumors, which was granted FDA Fast Track designation in February, as well as the recent clearance of our IND applications for AKY-2519. We are excited to accelerate the AKY-2519 program to patients in need of improved treatment options, and now expect to commence a Phase 1b trial of AKY-2519 in mid-2026. This momentum, together with our proprietary miniprotein radioconjugate platform, supply chain infrastructure, and strong cash position, strengthens our leadership in targeted radiopharmaceuticals.” Dr. Roden continued, “AKY-1189 and AKY-2519 each represent significant patient impact opportunities, with the potential to address multiple indications across various tumor types. We are working urgently to generate the clinical data necessary to support registrational trials for both programs.” Business updates and anticipated key milestones Pipeline AKY-1189, a novel miniprotein radioconjugate designed to selectively deliver 225Ac to Nectin-4 expressing tumors, is in an ongoing Phase 1b clinical trial enrolling patients with locally advanced or metastatic urothelial cancer (mUC), breast cancer, non-small cell lung cancer, colorectal cancer, cervical cancer, and head and neck cancer. In February 2026, the FDA granted Fast Track designation for AKY-1189 for the treatment of adult patients with locally advanced or mUC who have progressed on or after prior systemic therapies. AKY-2519, a miniprotein radioconjugate designed to selectively deliver 225Ac to B7-H3 expressing tumors, including prostate, lung and other solid tumors, is in an ongoing imaging and dosimetry clinical assessment of AKY-2519 to enable initial understanding of biodistribution and uptake in tumors and normal tissues. In March 2026, the FDA cleared the IND applications for [64Cu]Cu-AKY-2519 (imaging) and [225Ac]Ac-AKY-2519 (therapeutic use) to proceed to a Phase 1b clinical trial. Corporate On January 8, 2026, the Company priced an initial public offering (IPO) of its common stock, raising $365.4M gross proceeds, before underwriting discounts and other offering-related expenses. Anticipated key milestones for the next 12 months AKY-1189: Preliminary data from Part 1 of the ongoing Phase 1b clinical trial are expected in the first quarter of 2027. AKY-2519: Results from clinical imaging and dosimetry assessment of AKY-2519 in patients with various solid tumors are expected in mid-2026. Phase 1b clinical trial is expected to commence in mid-2026. The Company plans to provide further details on the overall clinical development strategy of AKY-2519 at that time. Early pipeline: Two programs are 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 is 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. 2025 financial results Cash position: Cash, cash equivalents and marketable securities were $226.8 million as of December 31, 2025, compared to $297.2 million as of December 31, 2024. Subsequent to December 31, 2025, the Company completed its IPO, generating net proceeds of approximately $335.3 million, after underwriting discounts, commissions and offering-related expenses. As a result, the Company’s pro forma as adjusted cash position as of year-end 2025 was $562.1 million, reflecting cash, cash equivalents and marketable securities as of December 31, 2025, plus net proceeds from the January 2026 IPO. The Company believes that the pro forma as adjusted cash position will fund its operations into 2029. Collaboration revenue: Collaboration revenue was $6.5 million for the year ended December 31, 2025, compared to $1.5 million for the year ended December 31, 2024. The increase was attributable to revenue recognized under the Company’s collaboration with Eli Lilly and Company, which was entered into in May 2024. In 2024, revenue recognition began in the fourth quarter, whereas a full year of revenue was recognized in 2025. R&D expenses: Research and development expenses were $67.5 million for the year ended December 31, 2025, compared to $41.0 million for the year ended December 31, 2024. The increase was primarily driven by higher headcount, and increased program expenses to support the advancement of AKY-1189 in a Phase 1b clinical trial and AKY-2519 IND-enabling studies and clinical imaging and dosimetry assessment. G&A expenses: General and administrative expenses were $13.7 million for the year ended December 31, 2025, compared to $12.6 million for the year ended December 31, 2024. The increase was primarily due to higher headcount to support the Company’s growing business. Net loss: Net loss was $63.7 million for the year ended December 31, 2025, compared to $44.0 million for the year ended December 31, 2024. The increase in net loss was primarily driven by the increase in R&D expenses described above. 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 anti-cancer 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, 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 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, non-small cell lung cancer, colorectal cancer, cervical cancer, and head and neck cancer. Aktis’ second pipeline program, AKY-2519, is a miniprotein radioconjugate targeting B7-H3 expressing tumors, including prostate, lung and other solid tumors. Aktis has a strategic collaboration with Eli Lilly and Company to leverage its miniprotein platform to develop novel radioconjugates outside of Aktis’ 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 Company’s limited operating history, its ability to obtain necessary funding, 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, its ability to identify additional product candidates, 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. Media contact: Melone Communications, LLC Liz Melone 617-256-6622 [email protected] Investor contact: Precision AQ Alex Lobo 212-698-8802 [email protected] _____________________ 1 IND applications were cleared for [64Cu]Cu-AKY-2519 for imaging and [225Ac]Ac-AKY-2519 for therapeutic use.
Investor releaseQuarter not tagged2026-02-02RADX Fiscal 1H:26 Activity and Cash Flows
Zacks Small Cap Research
RADX Fiscal 1H:26 Activity and Cash Flows
By John Vandermosten, CFA NASDAQ:RADX READ THE FULL RADX RESEARCH REPORT Radiopharm Theranostics (NASDAQ:RADX) released its first half 2026 cash flow statement on January 28th, 2026. The company has a June 30 fiscal year end and reports audited financial statements semiannually. We expect the half year report, prepared under International Financial Reporting Standards (IFRS), to be issued next month. The period captured in this report is from July 1st to December 31st 2025. Beyond the review of cash sources and uses for the first half of fiscal year 2026, the report summarizes the status of each of the company’s pipeline assets. Since the previous financial update, Radiopharm has presented interim data for its RAD101 imaging agent and reiterated upcoming milestones for RAD202 and RAD204, and anticipated delivery of data. Radiopharm’s operating activities consumed ($22.7) million for the six-month period ending December 31st, 2025. Cash from financing activities was $33.4 million for the same six-month period.[1] For the first six months of the reporting period ending December 31st, 2025: There were no cash receipts from customers; Research and development consumed ($19.4) million related to the management of multiple clinical trials; Advertising and marketing costs consumed ($228,000); Staff costs consumed ($6.3) million; Administration and corporate costs were ($1.9) million; Other miscellaneous cash operating contributions total $5.1 million, mostly impacted by $4.5 million in government grants and tax incentives; Other payments categorized as investing activities consumed ($5.3) million for payments of license fees; Financing cash was $33.4 million from the issuance of equity securities, partially offset by transaction costs. As of December 31st, 2025, Radiopharm held $34.5 million in cash compared to $19.0 million at the end of FY:25. Cash burn for 1H:26 was ($28.0) million. RAD101 Phase IIb Interim Analysis Radiopharm Theranostics reported the primary endpoint for its RAD101 trial in an interim analysis on December 15th. Following the release, management held a webcast which featured the company’s CEO, Riccardo Canevari, Chief Medical Officer Dr. Dimitris Voliotis, and the principal investigator on the RAD101 trial, Dr. Harshad Kulkarni. Topline from the release indicated that 92% (11/12) of evaluated patients treated with RAD101 achieved concordance wi…Read full documentShow less
By John Vandermosten, CFA NASDAQ:RADX READ THE FULL RADX RESEARCH REPORT Radiopharm Theranostics (NASDAQ:RADX) released its first half 2026 cash flow statement on January 28th, 2026. The company has a June 30 fiscal year end and reports audited financial statements semiannually. We expect the half year report, prepared under International Financial Reporting Standards (IFRS), to be issued next month. The period captured in this report is from July 1st to December 31st 2025. Beyond the review of cash sources and uses for the first half of fiscal year 2026, the report summarizes the status of each of the company’s pipeline assets. Since the previous financial update, Radiopharm has presented interim data for its RAD101 imaging agent and reiterated upcoming milestones for RAD202 and RAD204, and anticipated delivery of data. Radiopharm’s operating activities consumed ($22.7) million for the six-month period ending December 31st, 2025. Cash from financing activities was $33.4 million for the same six-month period.[1] For the first six months of the reporting period ending December 31st, 2025: There were no cash receipts from customers; Research and development consumed ($19.4) million related to the management of multiple clinical trials; Advertising and marketing costs consumed ($228,000); Staff costs consumed ($6.3) million; Administration and corporate costs were ($1.9) million; Other miscellaneous cash operating contributions total $5.1 million, mostly impacted by $4.5 million in government grants and tax incentives; Other payments categorized as investing activities consumed ($5.3) million for payments of license fees; Financing cash was $33.4 million from the issuance of equity securities, partially offset by transaction costs. As of December 31st, 2025, Radiopharm held $34.5 million in cash compared to $19.0 million at the end of FY:25. Cash burn for 1H:26 was ($28.0) million. RAD101 Phase IIb Interim Analysis Radiopharm Theranostics reported the primary endpoint for its RAD101 trial in an interim analysis on December 15th. Following the release, management held a webcast which featured the company’s CEO, Riccardo Canevari, Chief Medical Officer Dr. Dimitris Voliotis, and the principal investigator on the RAD101 trial, Dr. Harshad Kulkarni. Topline from the release indicated that 92% (11/12) of evaluated patients treated with RAD101 achieved concordance with Magnetic Resonance Imaging (MRI) imaging, which was the primary endpoint. RAD101 uptake was selective and significant in suspected or recurrent brain metastases. RAD202 RAD202, a Lu-177 bound nanobody targeting HER2, is being evaluated in the active HEAT trial for treatment of patients with Human Epidermal Growth Factor Receptor 2 (HER2)-positive advanced solid tumors. RAD202 was cleared to move to the next dose level of 75 mCi by the Data Safety and Monitoring Committee (DSMC). The study has completed dosing of the 30 mCi cohort and data from the first three patients in this cohort show significant tumor uptake in HER2 positive tumors. The principal investigators observed a favorable safety profile with no drug-related adverse events reported. RAD204 RAD204 is a Lu-177 bound nanobody targeting PD-L1 being evaluated for treatment of non-small cell lung cancer (NSCLC), small-cell lung cancer (SCLC), triple-negative breast cancer (TNBC), cutaneous melanoma, head and neck squamous cell carcinoma (HNSCC), and endometrial cancer. The first and second cohorts of the Phase I study are complete, and the third cohort is cleared to start at a 90 mCi dose of Lu-177. In the 30 mCi cohort, two of three patients achieved stable disease for 5.5 months compared to standard of care at 3.5 months. Tumor uptake for RAD204 in the first six patients in cohorts one and two shows results in line with previous imaging studies with the antibody. Investigators observe a reassuring safety profile, reporting no drug-related adverse events. RV01 RV01, also known as Betabart, is a monoclonal antibody targeting the 4Ig isoform of B7-H3. B7-H3 is highly expressed in a variety of tumors. RV01 is the subject of a joint venture between Radiopharm and MD Anderson Cancer Center. In January 2026, Radiopharm increased its ownership in the JV to 87.5% to reflect increasing interest in the asset. Last July, the FDA cleared RV01’s investigational new drug (IND) application, readying the candidate to begin a Phase I trial. Radiopharm expects to dose the first patients in 1Q:26. RV01 has a competitor in the B7-H3 targeting arena. Aktis Oncology (AKTS) recently held an initial public offering last month raising more than $365 million. A portion of these funds will be allocated to a Phase Ib trial for AKY-2519, which is an Ac-225 miniprotein radioconjugate targeting B7-H3. The marker is expressed in a wide variety of cancers, including colorectal, prostate, breast, and others.[2] A notable difference between the two candidates is the radioisotope used. While RV01 uses a Lutetium-177 radionuclide, which emits beta and gamma particles, AKY-2519 employs the alpha emitter Ac-225. Beta radiation has a low linear energy transfer with a medium sphere of impact, with the benefit of killing nearby tumor cells that do not express B7-H3. Alpha emitters are high-energy, short-range particles that cause double-strand DNA breaks and are more appropriate for precision treatment. AKY-2519 is now conducting investigational new drug (IND) enabling studies, while RV01 is the subject of a Phase I study. We anticipate that RV01 will dose its first patients in the next few weeks, giving a slight edge to Radiopharm on timing. RAD402 RAD402 binds a kallikrein-related peptidase 3 (KLK3) targeting antibody to a Terbium 161 isotope for treating prostate cancer. It will soon advance from the preclinical stage, where it demonstrated strong tumor targeting, limited bone marrow uptake, and a hepatic excretion profile consistent with other monoclonal antibodies in murine xenografts. Last November, RAD402 was granted clearance in Australia to begin a Phase I study for treatment of metastatic or locally advanced prostate cancer. The trial is expected to begin in 1Q:26. RAD301 RAD301 is the subject of a Phase I imaging trial in pancreatic ductal adenocarcinoma (PDAC). It is a Ga-68 radionuclide bound to an antibody targeting αvB-integrin. αvB-integrin is a cellular marker for tumor invasion and metastatic growth, which correlates with decreased survival in several carcinomas, particularly pancreatic. The candidate has been awarded an orphan drug designation by the FDA. Corporate Milestones[3] Oliver Sartor appointed to Scientific Advisory Board – July 2025 FDA clears IND for Phase I RV01 study – July 2025 Request for ethics approval for Phase I RAD402 trial - 3Q:25 Filing of FY:25 Annual Report – September 2025 RAD204 data from first two cohorts – 2H:25 RAD101 patient recruitment – 2H:25 Launch of Phase I RV01 (Betabart) trial – 4Q:25 Begin dosing patients in Phase I RAD 402 trial – 4Q:25 RAD301 Phase I last patient dosed – 4Q:25 RAD202 report data from first two cohorts - end of 2025 Dosing of first patients in RV01 trial – 1Q:26 RAD101 Phase III trial launch – 2H:26 RAD101 Phase II trial fully enrolled – February 2026 RAD402 Phase I trial initiation in metastatic or locally advanced prostate cancer – 1Q:26 RAD101 Phase II readout – 1H:26 RAD202 Phase I data release (2 cohorts) – 1H:26 RAD204 Phase I dose escalation complete – mid-2026 RAD202 Phase I last patient dosed – 2H:26 RAD301 Phase II trial start – 2H:26 RAD101 Phase III launch – 2H:26 RAD204 start Phase II study - 2027 RAD301 Phase II trial complete – 2H:27 RAD204 complete Phase II study – 4Q:27 RAD101 NDA submission - 2028 Summary Radiopharm issues its 1H:26 cash flow report and updates investors on the status of its pipeline programs. Just seven weeks ago, Radiopharm provided an interim look at its Phase IIb RAD101 trial, generating impressive results for its primary endpoint. Results demonstrated a 92% concordance between F-18 pivalate measured by PET and MRI for the first twelve patients in its trial. While not final data, these results in 11 of 12 patients show that RAD101 in PET scans provides valuable information to oncologists that can be used to determine optimal treatment. In many cases, results from MRI are inconclusive and may delay necessary treatment or lead to further and unnecessary SRS treatment. As for next milestones, we expect to see a further readout for RAD101 in 1H:26 and the launch of a Phase III study in 2H:26. We also expect to see interim data from the Phase I RAD202 and RAD204 studies in the middle of 2026. SUBSCRIBE TO ZACKS SMALL CAP RESEARCH to receive our articles and reports emailed directly to you each morning. Please visit our website for additional information on Zacks SCR. DISCLOSURE: Zacks SCR has received compensation from the issuer directly, from an investment manager, or from an investor relations consulting firm, engaged by the issuer, for providing research coverage for a period of no less than one year. Research articles, as seen here, are part of the service Zacks SCR provides and Zacks SCR receives payments totaling a maximum fee of up to $50,000 annually for these services provided to or regarding the issuer. Full Disclaimer HERE. ________________________ [1] Note that results are reported in Australian Dollars. The most recent exchange rate between Australian Dollars and U.S. Dollars is $1.44 AUD to $1.00 USD. [2] The Human Protein Atlas. CD276 (B7-H3). Expression in cancer. [3] Quarters and halves listed in the milestones section are calendar quarters and halves in contrast to Radiopharm’s June 30 fiscal year end.

