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Aktis Oncology (AKTS) posts Q2 2026 results with $517M cash runway into 2029

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(Moderate)
Filing Sentiment
(Neutral)
Form Type
8-K

Rhea-AI Filing Summary

Aktis Oncology, Inc. reported second quarter 2026 results and outlined progress across its targeted radiopharmaceutical pipeline. The company highlighted first-in-human imaging and dosimetry data for AKY-2519 showing robust tumor uptake and limited normal tissue exposure, and continued enrollment in a Phase 1b trial of AKY-1189 in urothelial and other Nectin-4 expressing tumors. Aktis initiated a Phase 1b trial of AKY-2519 in metastatic castration-resistant prostate cancer and cleared regulatory review for a Phase 1b basket trial in other B7-H3 expressing tumors, both expected to yield preliminary data in 2027. An in-house GMP facility is expected to be operational in the second half of 2026 to support clinical supply. Cash, cash equivalents, and marketable securities were $517.3 million as of June 30, 2026, expected to fund operations into 2029. For the quarter, collaboration revenue was $3.4 million, research and development expenses $25.3 million, general and administrative expenses $7.0 million, and net loss $24.1 million.

Positive

  • Cash, cash equivalents, and marketable securities of $517.3 million as of June 30, 2026 are expected to fund the operating plan into 2029, providing a multi-year capital runway for clinical development and infrastructure build-out.
  • Collaboration revenue rose to $3.4 million in Q2 2026 from $1.6 million a year earlier, driven by advancement of the Eli Lilly research collaboration with revenue recognized over time.

Negative

  • Net loss increased to $24.1 million for Q2 2026 from $18.1 million in the prior-year period, reflecting higher research and development and general and administrative expenses.
  • Research and development expenses grew to $25.3 million from $18.6 million year over year, and general and administrative expenses to $7.0 million from $3.9 million, indicating a rising cost base.
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, and exhibit attachments filed with this report.
Cash, cash equivalents, and marketable securities $517,320 thousand As of June 30, 2026; expected to fund operating plan into 2029
Collaboration revenue Q2 2026 $3,384 thousand Three months ended June 30, 2026 vs $1,601 thousand in 2025
Research and development expenses Q2 2026 $25,280 thousand Three months ended June 30, 2026 vs $18,628 thousand in 2025
General and administrative expenses Q2 2026 $7,003 thousand Three months ended June 30, 2026 vs $3,936 thousand in 2025
Net loss Q2 2026 $24,144 thousand Three months ended June 30, 2026 vs $18,075 thousand in 2025
Total assets June 30, 2026 $557,596 thousand Balance sheet data as of June 30, 2026
Total liabilities June 30, 2026 $72,758 thousand Balance sheet data as of June 30, 2026
miniprotein radioconjugate medical
"AKY-1189 is a novel, clinical-stage miniprotein radioconjugate designed to selectively deliver"
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.
dosimetry medical
"Presented first-in-human clinical imaging and dosimetry data for AKY-2519 across several"
Dosimetry is the measurement and calculation of how much ionizing radiation is absorbed by people, tissues, or devices, similar to a thermostat tracking temperature in different rooms to know where and how much heat is present. Investors should care because accurate dosimetry underpins safety, treatment effectiveness, regulatory approval, and liability for products and services that use radiation—affecting market access, costs, and commercial risk.
Good Manufacturing Practices (GMP) technical
"In-house Good Manufacturing Practices (GMP) facility expected to be operational in the second"
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.
IND-enabling activities regulatory
"Two programs tracking toward development candidate nomination and commencement of IND-enabling activities"
IND-enabling activities are the lab tests, animal studies and manufacturing checks a company performs to demonstrate a new drug is reasonably safe and can be produced reliably before filing an Investigational New Drug (IND) application to begin human trials. For investors these steps are a key milestone because completing them reduces safety and regulatory risk, requires substantial time and funding, and signals that a program is ready to move from early development into clinical testing—like building a foundation before constructing a house.
metastatic castration-resistant prostate cancer (mCRPC) medical
"Initiated Phase 1b trial of AKY-2519 in metastatic castration-resistant prostate cancer (mCRPC)"
An advanced form of prostate cancer that has spread beyond the prostate and keeps growing even after standard hormone-lowering treatments no longer work. Investors pay attention because it creates a clear need for new therapies and diagnostic tools: successful clinical trial results, regulatory approvals, or safe effective drugs can drive substantial revenue and stock moves, while failed trials or safety problems can sharply reduce a company’s value—like pests that survive a common pesticide and demand a new solution.
B7-H3 expressing solid tumors medical
"to initiate Phase 1b trial of AKY-2519 in other B7-H3 expressing solid tumors, including lung"
Collaboration revenue Q2 2026 $3,384 thousand Increased from $1,601 thousand for the quarter ended June 30, 2025
Research and development expenses Q2 2026 $25,280 thousand Increased from $18,628 thousand for the quarter ended June 30, 2025
General and administrative expenses Q2 2026 $7,003 thousand Increased from $3,936 thousand for the quarter ended June 30, 2025
Net loss Q2 2026 $24,144 thousand Increased from $18,075 thousand for the quarter ended June 30, 2025

FAQ

What were Aktis Oncology (AKTS) key financial results for Q2 2026?
Aktis reported Q2 2026 collaboration revenue of $3.4 million and a net loss of $24.1 million. Research and development expenses were $25.3 million and general and administrative expenses were $7.0 million for the quarter ended June 30, 2026.

How much cash does Aktis Oncology (AKTS) have and how long will it last?
As of June 30, 2026, Aktis held $517.3 million in cash, cash equivalents, and marketable securities. The company states this balance is expected to fund its operating plan into 2029, following net proceeds from its January 2026 initial public offering.

What clinical progress did Aktis Oncology (AKTS) report for AKY-2519?
Aktis presented first-in-human imaging and dosimetry data for AKY-2519 showing robust tumor uptake with limited normal tissue exposure. The company is enrolling a Phase 1b mCRPC trial and cleared regulatory review for a Phase 1b basket trial in other B7-H3 expressing tumors.

What are the upcoming milestones for Aktis Oncology (AKTS) over the next year?
Aktis expects to start the Phase 1b BActinium-2 basket trial for AKY-2519 in the second half of 2026, obtain preliminary AKY-1189 Phase 1b-2 data in the first quarter of 2027, and advance two early programs toward IND-enabling activities in the first quarter of 2027.

How is Aktis Oncology (AKTS) investing in manufacturing capabilities?
The company plans for an in-house Good Manufacturing Practices (GMP) facility to be operational in the second half of 2026. This facility is part of a hybrid manufacturing strategy to expand capabilities and support clinical supply for its radiopharmaceutical pipeline.

What collaboration does Aktis Oncology (AKTS) have with Eli Lilly?
Aktis has a discovery collaboration with Eli Lilly and Company using its miniprotein platform to develop novel radioconjugates outside its proprietary pipeline. Collaboration revenue was $3.4 million in Q2 2026, recognized over time using the cost incurred input method.

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Understanding 8-K Material Events →
false000203583200020358322026-08-132026-08-13

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): August 13, 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 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.

 

 

 

Exhibit
No.

Description

99.1*

Press Release, dated August 13, 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: August 13, 2026

 

By:

/s/ Kyle Kuvalanka

 

 

 

Kyle Kuvalanka

 

 

 

Chief Financial Officer

 

 

 

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, 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.

 

•
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.

 

1

 

 

•
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.
o
Data demonstrated robust tumor uptake and retention of AKY-2519 with limited normal tissue exposure, suggesting the potential for a wide therapeutic window and differentiated profile compared to approved radiopharmaceuticals.
o
Imaging and dosimetry with AKY-2519 were generally well tolerated, with no reported adverse events or infusion-related reactions. For more information, read the press release here.
•
Enrolling patients in Phase 1b, multicenter, open-label BActinium-1 clinical trial of AKY-2519 in PLUVICTO®-naïve and -experienced patients with mCRPC.
•
Cleared regulatory review to initiate Phase 1b, multicenter, open-label BActinium-2 clinical trial of AKY-2519 in patients with various other B7-H3 expressing tumors.

 

Anticipated milestones for the next 12 months

 

•
AKY-1189:
o
Expect preliminary data from the ongoing Phase 1b NECTINIUM-2 clinical trial in the first quarter of 2027.
•
AKY-2519:
o
Expect to commence Phase 1b BActinium-2 basket trial in lung and other B7-H3 expressing solid tumor cancers in the second half of 2026.
o
Expect preliminary data from Phase 1b mCRPC clinical trial in 2027.
•
Early pipeline:
o
Two programs tracking toward development candidate nomination and commencement of IND-enabling activities in the first quarter of 2027.
•
Corporate:
o
In-house Good Manufacturing Practices (GMP) facility expected to be operational in the second half of 2026 as part of the Company’s hybrid manufacturing strategy to expand capabilities and support clinical supply demand.

 

Second quarter 2026 financial results

 

•
Cash position: Cash, cash equivalents, and marketable securities were $517.3 million as of June 30, 2026, compared to $226.8 million as of December 31, 2025. The increase in cash, cash equivalents, and marketable securities reflects net proceeds from the Company’s initial public offering in January 2026, primarily offset by cash used in operations. The Company’s cash, cash equivalents, and marketable securities as of June 30, 2026, are expected to fund the Company’s operating plan into 2029.
•
Collaboration revenue: Collaboration revenue was $3.4 million for the quarter ended June 30, 2026, compared to $1.6 million for the comparable prior-year period. The increase of $1.8 million was attributable to continued advancement of the Company’s research collaboration with Eli Lilly and Company, with revenue recognized over time using the cost incurred input method.
•
R&D expenses: Research and development expenses were $25.3 million for the quarter ended June 30, 2026, compared to $18.6 million for the comparable prior-year period. The increase of

2

 

 

$6.7 million was primarily driven by ongoing operations of the Company’s Phase 1b clinical trial for AKY-1189 and the IND-enabling studies and initiation of clinical trials for AKY-2519.
•
G&A expenses: General and administrative expenses were $7.0 million for the quarter ended June 30, 2026, compared to $3.9 million for the comparable prior-year period. The increase of $3.1 million was primarily due to higher employee-related costs (including stock-based compensation) associated with increased hiring to support the Company’s growth, as well as increased expenses related to operating as a public company.
•
Net loss: Net loss was $24.1 million for the quarter ended June 30, 2026, compared to $18.1 million for the comparable prior-year period. The increase in net loss of $6.0 million was primarily driven by higher operating expenses offset by interest income, net of $4.8 million in the quarter.

 

About Aktis’ miniprotein radioconjugate platform

Aktis has developed a proprietary, isotope-agnostic miniprotein radioconjugate platform to selectively deliver the tumor-killing properties of radioisotopes to targeted tumors. Aktis’ therapeutic miniprotein radioconjugates are designed to maximize anticancer activity through high tumor penetration coupled with internalization and retention in cancer cells, while rapidly clearing from normal organs and tissues. The Aktis platform further enables clinicians to visualize and verify target engagement with imaging isotopes prior to exposure to therapeutic radioisotopes. Leveraging this platform, and its patient-first end-to-end clinical supply chain built for resiliency and scalability, Aktis is advancing a pipeline of next-generation targeted radiopharmaceuticals to address the unmet needs of patients across a broad spectrum of solid tumors.

About Aktis Oncology

Aktis Oncology, Inc. is a clinical-stage oncology company focused on expanding the breakthrough potential of targeted radiopharmaceuticals to large patient populations, including those not addressed by existing platform technologies. Aktis’ most advanced clinical-stage pipeline program, AKY-1189, is a miniprotein radioconjugate targeting Nectin-4, with multi-indication potential across multiple tumor types, including locally advanced or metastatic urothelial cancer, breast cancer, and other solid tumor cancers. Aktis’ second clinical-stage pipeline program, AKY-2519, is a miniprotein radioconjugate targeting B7-H3 expressing tumors, including prostate, lung, and other solid tumors. Aktis has a discovery collaboration with Eli Lilly and Company to leverage Aktis’ miniprotein platform to develop novel radioconjugates outside of its proprietary pipeline. For more information, please visit 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

3

 

 

inherent in clinical development, the timing and scope of regulatory approvals, changes in laws and regulations to which the Company is subject, competitive pressures, risks relating to business interruptions, and other risks set forth under the heading “Risk Factors” of the Company’s Annual Report on Form 10-K for the year ended December 31, 2025, and in subsequent filings with the Securities and Exchange Commission. The Company’s actual results could differ materially from the results described in or implied by such forward-looking statements. Forward-looking statements speak only as of the date hereof, and, except as required by law, the Company undertakes no obligation to update or revise these forward-looking statements.

 

 

 

 

AKTIS ONCOLOGY, INC.

CONDENSED CONSOLIDATED STATEMENT OF OPERATIONS

(In thousands)

(Unaudited)

 

 

 

Three Months Ended June 30,

 

 

Six Months Ended June 30,

 

 

2026

 

 

2025

 

 

2026

 

 

2025

 

Revenue:

 

 

 

 

 

 

 

 

 

 

 

Collaboration revenue

$

3,384

 

 

$

1,601

 

 

$

6,611

 

 

$

3,048

 

Operating expenses:

 

 

 

 

 

 

 

 

 

 

 

Research and development

 

25,280

 

 

 

18,628

 

 

 

45,316

 

 

 

34,491

 

General and administrative

 

7,003

 

 

 

3,936

 

 

 

12,900

 

 

 

7,663

 

Total operating expenses

 

32,283

 

 

 

22,564

 

 

 

58,216

 

 

 

42,154

 

Loss from operations

 

(28,899

)

 

 

(20,963

)

 

 

(51,605

)

 

 

(39,106

)

Other income (expense):

 

 

 

 

 

 

 

 

 

 

 

Interest income

 

4,765

 

 

 

2,908

 

 

 

9,149

 

 

 

6,079

 

Other expense, net

 

(10

)

 

 

(20

)

 

 

(13

)

 

 

(33

)

Total other income, net

 

4,755

 

 

 

2,888

 

 

 

9,136

 

 

 

6,046

 

Net loss

$

(24,144

)

 

$

(18,075

)

 

$

(42,469

)

 

$

(33,060

)

 

4

 

 

 

AKTIS ONCOLOGY, INC.

BALANCE SHEET DATA

(In thousands)

(Unaudited)

 

 

 

June 30,

 

 

December 31,

 

 

2026

 

 

2025

 

Cash, cash equivalents, and marketable securities

$

517,320

 

 

$

226,787

 

Total assets

 

557,596

 

 

 

264,885

 

Total liabilities

 

72,758

 

 

 

77,625

 

Total stockholders' equity and redeemable convertible preferred stock

$

484,838

 

 

$

187,260

 

 

 

Media contact:
Melone Communications, LLC
Liz Melone

617-256-6622

liz@melonecomm.com

 

Investor contact:
Precision AQ

Alex Lobo

212-698-8802

Alex.lobo@precisionaq.com

5

 

Source: View Original Filing on SEC EDGAR

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