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Aktis Oncology 2025 results, FDA clears new INDs

Aktis Oncology reported 2025 results and highlighted major R&D and financing milestones.

Filing Impact
(High)
Filing Sentiment
(Neutral)
Form Type
8-K

Rhea-AI Filing Summary

Aktis Oncology reported 2025 results and highlighted major R&D and financing milestones. The FDA cleared Investigational New Drug applications for AKY-2519, enabling a Phase 1b trial in mid-2026, while lead program AKY-1189 continues enrolling in a Phase 1b study and received Fast Track designation in February 2026.

Cash, cash equivalents and marketable securities were $226.8 million as of December 31, 2025, with a pro forma as adjusted cash position of $562.1 million after the January 2026 IPO, which the company believes will fund operations into 2029. 2025 collaboration revenue was $6.5 million, R&D expenses were $67.5 million, G&A expenses were $13.7 million, and net loss was $63.7 million, all higher than 2024 as the pipeline and organization expanded.

Positive

  • Strong cash runway into 2029: Pro forma as adjusted cash of $562.1 million after the January 2026 IPO is expected to fund operations into 2029, supporting multiple clinical programs and infrastructure build-out.
  • Key regulatory milestones achieved: FDA Fast Track designation for AKY-1189 and IND clearances for AKY-2519 enable expansion of the clinical pipeline and potentially faster development paths in significant tumor indications.

Negative

  • None.

Insights

IND clearances, Fast Track status and a long cash runway support Aktis Oncology’s expanded clinical plans.

Aktis Oncology is progressing two clinical-stage miniprotein radioconjugates. The FDA granted Fast Track designation to AKY-1189 in February 2026 and cleared IND applications for AKY-2519 in March 2026, allowing a Phase 1b trial to start in mid-2026.

Financially, collaboration revenue rose to $6.5 million in 2025, while R&D spending increased to $67.5 million as programs advanced. Net loss widened to $63.7 million, typical for a clinical-stage biotech investing in development.

After the January 2026 IPO, pro forma as adjusted cash totaled $562.1 million, and the company believes this will fund operations into 2029. That multi-year runway underpins plans for AKY-1189 and AKY-2519 data readouts and early-pipeline progress, though execution and clinical results will ultimately determine value.

Item 2.02 Results of Operations and Financial Condition Financial
Disclosure of earnings results, typically an earnings press release or preliminary financials.
Item 9.01 Financial Statements and Exhibits Exhibits
Financial statements, pro forma financial information, or exhibit attachments filed with this report.
Cash, cash equivalents and marketable securities $226.8 million As of December 31, 2025
Pro forma as adjusted cash $562.1 million Year-end 2025 including January 2026 IPO net proceeds
Collaboration revenue $6.5 million Year ended December 31, 2025 (vs. $1.5 million in 2024)
Research and development expenses $67.5 million Year ended December 31, 2025 (vs. $41.0 million in 2024)
General and administrative expenses $13.7 million Year ended December 31, 2025 (vs. $12.6 million in 2024)
Net loss $63.7 million Year ended December 31, 2025 (vs. $44.0 million in 2024)
IPO net proceeds $335.3 million Net proceeds from January 2026 IPO after costs
Investigational New Drug (IND) regulatory
"the U.S. Food and Drug Administration (FDA) cleared the Investigational New Drug (IND) applications"
An investigational new drug (IND) is a drug or biologic that is being tested but has not yet been approved for general use; it is the application and formal status that allows a company to begin human clinical trials under regulator oversight. Investors care because an IND marks the transition from lab work to human testing — like getting a permit to run real-world experiments — which creates important milestones, costs, timelines and regulatory risk that drive a development-stage company's value.
Fast Track designation regulatory
"the FDA granted Fast Track designation for AKY-1189 for the treatment of adult patients"
Fast track designation is a status the U.S. Food and Drug Administration grants to drugs intended to treat serious conditions and address an unmet medical need. It gives the developer more frequent communication with the FDA and can allow parts of the application to be reviewed on a rolling basis, and it may pave the way to priority review or accelerated approval. It can shorten development timelines, though it does not guarantee approval.
miniprotein radioconjugate medical
"AKY-1189, a novel miniprotein radioconjugate designed to selectively deliver 225Ac"
A miniprotein radioconjugate is a tiny, engineered protein attached to a radioactive atom that can either highlight or destroy specific cells in the body, such as tumors. For investors, it matters because this type of targeted tool can improve diagnostic imaging or deliver focused treatments with potentially fewer side effects, which affects a drug developer’s clinical value, manufacturing complexity, regulatory hurdles and commercial potential much like upgrading from a flashlight to a laser-guided pointer.
Good Manufacturing Practices (GMP) regulatory
"In-house Good Manufacturing Practices (GMP) facility is expected to be operational"
Good manufacturing practices (GMP) are the set of rules and controls that ensure drugs, medical devices, and related products are made cleanly, consistently, and to the quality claimed on the label. For investors, GMP matters because meeting these standards reduces the chance of product recalls, production shutdowns, fines, or lost approvals—similar to a restaurant that follows strict recipes and hygiene to avoid food poisoning and keep customers coming back.
collaboration revenue financial
"Collaboration revenue was $6.5 million for the year ended December 31, 2025"
Payments a company receives from business partners under joint development, commercialization, or licensing agreements—often including upfront fees, milestone payments and a share of product sales—earned as part of a formal collaboration. Investors care because this income can validate a company’s technology, boost cash flow and reduce the cost of bringing products to market, but it is often lumpy and contingent on future milestones and partner performance, so it affects revenue predictability and valuation.
Collaboration revenue $6.5 million +$5.0 million YoY
Net loss $63.7 million -$19.7 million YoY
Cash, cash equivalents and marketable securities $226.8 million -$70.4 million YoY

FAQ

AI-generated questions and answers. How Rhea-AI works. Not financial advice.

What were Aktis Oncology (AKTS) 2025 financial results?
Aktis Oncology reported 2025 collaboration revenue of $6.5 million, research and development expenses of $67.5 million, general and administrative expenses of $13.7 million, and a net loss of $63.7 million, reflecting increased investment in its radioconjugate pipeline and corporate growth versus 2024.

How much cash does Aktis Oncology (AKTS) have after its IPO?
As of December 31, 2025, Aktis Oncology held $226.8 million in cash, cash equivalents and marketable securities. Including approximately $335.3 million in net IPO proceeds, its pro forma as adjusted cash position was $562.1 million, which it believes will fund operations into 2029.

What recent FDA milestones did Aktis Oncology (AKTS) achieve?
The FDA granted Fast Track designation to AKY-1189 in February 2026 for certain urothelial cancer patients and in March 2026 cleared IND applications for AKY-2519, covering both imaging and therapeutic uses, enabling progression to a Phase 1b clinical trial.

What are the key upcoming clinical milestones for Aktis Oncology (AKTS)?
Aktis expects clinical imaging and dosimetry results for AKY-2519 in mid-2026 and plans to start a Phase 1b trial then. Preliminary data from Part 1 of the AKY-1189 Phase 1b trial and two early pipeline development candidate nominations are targeted for the first quarter of 2027.

How is Aktis Oncology (AKTS) investing in manufacturing capabilities?
Aktis plans to bring an in-house Good Manufacturing Practices (GMP) facility online in the second half of 2026 as part of a hybrid manufacturing strategy. This is intended to expand capabilities and support growing clinical supply needs for its miniprotein radioconjugate programs.

What collaboration revenue did Aktis Oncology (AKTS) generate in 2025?
Collaboration revenue reached $6.5 million in 2025, up from $1.5 million in 2024. The increase primarily reflects a full year of revenue recognition from its collaboration with Eli Lilly and Company, which began contributing revenue in the fourth quarter of 2024.

AI-generated analysis. How Rhea-AI works. Not financial advice.

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0002035832false00020358322026-03-302026-03-30

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

FORM 8-K

CURRENT REPORT

Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934

Date of Report (Date of earliest event reported): March 30, 2026

Aktis Oncology, Inc.

(Exact name of registrant as specified in its charter)

 

 

 

 

 

Delaware

001-43047

85-2584233

(State or other jurisdiction

of incorporation)

(Commission

File Number)

(IRS Employer

Identification No.)

 

17 Drydock Avenue, Suite 17-401

Boston, Massachusetts 02210

(Address of principal executive offices) (Zip Code)

Registrant’s telephone number, including area code: (617) 461-4023

N/A

(Former name, or former address, if changed since last report)

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:

☐

Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

☐

Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

☐

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:

 

 

 

 

 

Title of each class

Trading

Symbol(s)

Name of each exchange

on which registered

Common Stock, par value $0.0001

per share

AKTS

The Nasdaq Stock Market LLC

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 March 30, 2026, Aktis Oncology, Inc. issued a press release announcing its financial results for the year ended December 31, 2025 and provided a business update. 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.

 

 

 

Exhibit
No.

Description

99.1*

Press Release, dated March 30, 2026

104

 

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.

 

 

 

 

 

 

 

 

 

AKTIS ONCOLOGY, INC.
 

 

 

 

 

Date: March 30, 2026

 

By:

/s/ Kyle Kuvalanka

 

 

 

Kyle Kuvalanka

 

 

 

Chief Financial Officer

 

 

Exhibit 99.1

 

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-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.”

 

1 IND applications were cleared for [64Cu]Cu-AKY-2519 for imaging and [225Ac]Ac-AKY-2519 for therapeutic use.

 

 

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.

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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

3

 

 

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

liz@melonecomm.com

Investor contact:
Precision AQ

Alex Lobo

212-698-8802

Alex.lobo@precisionaq.com

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Source: View Original Filing on SEC EDGAR

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