Aktis Oncology Reports Third-Quarter Financial Results and Highlights Clinical Trial Progress

Rhea-AI Summary

Aktis Oncology (NASDAQ:AKTS) reported third-quarter financial results and initiated a Phase 1b trial expanding AKY-2519 evaluation to lung cancer. Collaboration revenue rose to $3.905 million from $1.579 million a year earlier, while net loss widened to $29.939 million from $15.533 million. Cash, cash equivalents and marketable securities totaled $492.929 million at September 30, 2026; Aktis expects these funds to support its operating plan into 2029.

The new BActinium-2 trial covers non-small cell lung cancer and other B7-H3 expressing tumors. Additional enrollment began at selected doses in NECTINIUM-2 and BActinium-1 while dose escalation continues. Aktis expects preliminary AKY-1189 data in the first quarter of 2027 and AKY-2519 data in 2027, with its newly operational in-house manufacturing facility expected to supply clinical trials in the first half of 2027.

16 points · 0 major

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0 major · 8 points

Hollow bars mark forward-looking points. How the balance works

Positive

• Moderate pointCash, cash equivalents and marketable securities increased to $492.929 million from $226.787 million at December 31, 2025.
• Moderate point. Forward-looking: it has not happened yet and may not happen.Aktis expects its September 30, 2026 funds to support its operating plan into 2029.
• Minor pointThird-quarter collaboration revenue increased to $3.905 million from $1.579 million a year earlier.
• Minor pointBActinium-2 Phase 1b trial initiated, evaluating AKY-2519 in non-small cell lung cancer and other B7-H3 expressing tumors.
• Minor pointNECTINIUM-2 additional enrollment began at 6 MBq, a radioactivity dose, for up to 30 patients.

11 minor points

• Minor pointBActinium-1 additional enrollment began at 9 MBq in PLUVICTO-naïve and PLUVICTO-experienced cohorts, up to 30 patients each.
• Minor point. Forward-looking: it has not happened yet and may not happen.Aktis expects preliminary AKY-1189 data in first-quarter 2027 from the Phase 1b NECTINIUM-2 trial.
• Minor point. Forward-looking: it has not happened yet and may not happen.Aktis expects preliminary AKY-2519 data in 2027 from the Phase 1b BActinium-1 trial.
• Minor point. Forward-looking: it has not happened yet and may not happen.Aktis began in-house drug manufacturing; clinical-trial supply from the facility is expected in first-half 2027.
• Minor point. Forward-looking: it has not happened yet and may not happen.Two early programs are tracking toward candidate nomination and preclinical regulatory-support activities in first-quarter 2027.
• Minor pointThird-quarter interest income increased to $4.822 million from $2.682 million a year earlier.
• Minor pointNine-month collaboration revenue increased to $10.516 million from $4.627 million a year earlier.
• Minor pointNine-month interest income increased to $13.971 million from $8.761 million a year earlier.
• Minor pointTotal assets increased to $532.484 million from $264.885 million at December 31, 2025.
• Minor pointTotal liabilities decreased to $73.612 million from $77.625 million at December 31, 2025.
• Minor pointStockholders' equity and redeemable convertible preferred stock increased to $458.872 million from $187.260 million at December 31, 2025.

Negative

• Moderate pointThird-quarter net loss widened to $29.939 million from $15.533 million a year earlier.
• Minor pointThird-quarter research and development expenses increased to $32.125 million from $16.467 million a year earlier.
• Minor pointThird-quarter general and administrative expenses increased to $6.527 million from $3.315 million a year earlier.
• Minor pointThird-quarter operating loss widened to $34.747 million from $18.203 million a year earlier.
• Minor pointNine-month net loss widened to $72.408 million from $48.593 million a year earlier.

3 minor points

• Minor pointNine-month research and development expenses increased to $77.441 million from $50.958 million a year earlier.
• Minor pointNine-month general and administrative expenses increased to $19.427 million from $10.978 million a year earlier.
• Minor pointNine-month operating loss widened to $86.352 million from $57.309 million a year earlier.

News Explained

Aktis has begun making drug product at its in-house GMP facility, but its inclusion as a clinical-supply manufacturer remains planned: the company intends to amend the AKY-1189 and AKY-2519 INDs for that purpose.

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Market move: AKTS -4.46% in the Nov 12 session. third-quarter earnings report

$908.27M Mkt Cap at Peak Alert

On Nov 12, the day this news came out, AKTS closed 4.46% below the previous close. Our momentum scanner recorded 6 alerts for this stock that day.

Data tracked by StockTitan Argus for the Nov 12 session.

Key Figures

Cash, cash equivalents, and marketable securities: $492.9 million vs. $226.8 million Operating-plan funding runway: Into 2029 Collaboration revenue: $3.9 million vs. $1.6 million +4 more

Cash, cash equivalents, and marketable securities

$492.9 million vs. $226.8 million

September 30, 2026 vs. December 31, 2025

Operating-plan funding runway

Into 2029

Based on cash, cash equivalents, and marketable securities at September 30, 2026

Collaboration revenue

$3.9 million vs. $1.6 million

Quarter ended September 30, 2026 vs. comparable prior-year period

Research and development expenses

$32.1 million vs. $16.5 million

Quarter ended September 30, 2026 vs. comparable prior-year period

Net loss

$29.9 million vs. $15.5 million

Quarter ended September 30, 2026 vs. comparable prior-year period

NECTINIUM-2 backfill

6 MBq; up to 30 patients

Initial backfill dose level in the Phase 1b trial

BActinium-1 backfill

9 MBq; up to 30 patients per cohort

PLUVICTO-naïve and PLUVICTO-experienced cohorts

Historical Context

1 past event · Latest: Aug 13

1 event

1. Aug 13

   Q2 earnings report

   24h Move

   +4.8%

   Q2 cash runway and comparable revenue, R&D spending, and net loss provide a prior-quarter baseline.

24h Move is the share-price change in the day after each event; other market factors may also have contributed.

Key Terms

actinium-225, phase 1b, open-label, gmp, +1 more

5 terms

actinium-225 medical

"selectively deliver actinium-225 (225Ac) to tumors"

Actinium-225 is a rare, radioactive form of the metal actinium used as a microscopic radiation source in some cancer treatments; it emits very strong, short-range radiation that can destroy diseased cells when attached to a carrier drug. Investors pay attention because supply is limited and production is complex, so shortages or cost changes can directly affect the development, manufacturing and valuation of companies pursuing therapies that rely on this scarce medical “fuel.”

phase 1b medical

"Dose escalation is ongoing in the Phase 1b NECTINIUM-2 trial"

"Phase 1b" is an early stage in testing a new medical treatment or vaccine, where it is given to a small group of people to evaluate its safety and determine the right dose. For investors, this phase signals progress in development, indicating the treatment is advancing through initial safety checks, which can influence expectations for future success and potential market impact.

open-label medical

"Phase 1b multicenter, open-label clinical trial"

Open-label describes a situation where everyone involved in a study or process knows the full details, such as who is receiving a treatment or intervention. For investors, understanding whether a project or product is open-label helps gauge the level of transparency and potential biases, influencing trust and decision-making. It’s like knowing whether a test or experiment is conducted openly or behind closed doors.

gmp technical

"operationalized our in-house GMP facility"

Good Manufacturing Practice (GMP) is a set of regulatory standards and procedures that ensure products—especially medicines, medical devices, and related goods—are consistently made to meet safety, quality, and purity requirements. For investors, GMP compliance is like a factory’s hygiene and checklist system: it reduces the risk of product recalls, regulatory fines, and production stoppages, supports market access, and signals more reliable, lower-risk operations that can protect revenue and reputation.

nsclc medical

"patients with non-small cell lung cancer (NSCLC)"

NSCLC stands for non-small cell lung cancer, which is the most common type of lung cancer. It develops in the lungs and can spread to other parts of the body, making it serious but often treatable if caught early. Understanding NSCLC helps people recognize the importance of lung health and early detection.

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

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• Initiated the Company’s third Phase 1b clinical trial, BActinium-2, broadening the evaluation of AKY-2519 to lung cancer and other B7-H3 expressing tumors
• Started first backfill cohorts in the ongoing Phase 1b NECTINIUM-2 clinical trial of AKY-1189 and Phase 1b BActinium-1 clinical trial of AKY-2519
• On track to present preliminary data for AKY-1189 in first quarter of 2027 and AKY-2519 in 2027
  
  

BOSTON, Nov. 12, 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, today reported financial results for the third quarter ended September 30, 2026, and provided a business update, including progress with the Company’s two clinical-stage programs.

“Aktis is on a trajectory to redefine radiopharmaceuticals as a major pillar of cancer treatment by expanding the modality to more targets, broader indications, and larger patient populations. In the third quarter, we continued to make tremendous progress operationalizing this vision,” said Matthew Roden, Ph.D., President and Chief Executive Officer at Aktis Oncology. “With the initiation of the BActinium-2 trial of AKY-2519, we now have three clinical trials underway in the U.S. across two novel targets, Nectin-4 and B7-H3, which are both implicated in a range of solid tumor types. We also opened the first backfill cohorts in our ongoing NECTINIUM-2 and BActinium-1 trials to further characterize safety and preliminary antitumor activity at the selected doses, while dose escalation continues in both studies. This substantial clinical progress is a testament to our ability to execute rapidly with quality across multiple clinical trials and positions Aktis for a data-rich 2027.”

Third quarter 2026 and recent business highlights

AKY-1189

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 locally advanced or metastatic urothelial cancer (mUC) and breast cancer.

• Dose escalation is ongoing in the Phase 1b NECTINIUM-2 trial evaluating AKY-1189 in patients with locally advanced or mUC and other Nectin-4 expressing solid tumors.
• Aktis initiated backfill at the 6 MBq dose level to further characterize safety and preliminary antitumor activity in up to 30 patients. This is the first of up to two dose levels planned to be selected for backfill.

AKY-2519

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 tumors.

• Aktis initiated the Phase 1b BActinium-2 trial evaluating AKY-2519 in patients with non-small cell lung cancer (NSCLC) and other B7-H3 expressing solid tumors.
• Dose escalation is ongoing in the Phase 1b BActinium-1 trial evaluating AKY-2519 in patients with metastatic castration-resistant prostate cancer (mCRPC), including PLUVICTO®-naïve and PLUVICTO-experienced patients.
• In the Phase 1b BActinium-1 trial, Aktis initiated backfill at the 9 MBq dose level for both the PLUVICTO-naïve and PLUVICTO-experienced cohorts to further characterize safety and preliminary antitumor activity in up to 30 patients per cohort. This is the first of up to two planned dose levels that will be backfilled in each of the mCRPC patient populations.
  

Dr. Roden added, “With our robust end-to-end supply chain supported by multiple contract manufacturing organizations and isotope suppliers, we are successfully delivering clinical supply for our clinical trials nationally. In the quarter, we operationalized our in-house GMP facility at 17 Drydock in Boston, where we expect to begin supplying drug product for our clinical trials in the first half of 2027, further expanding manufacturing capacity for clinical supply. The 17 Drydock facility progresses our strategy to build capabilities to support potential Phase 3 trials and commercial product supply in a capital-efficient manner.”

Manufacturing

• Aktis began manufacturing drug product in its in-house GMP facility, as part of the Company’s hybrid sourcing manufacturing strategy. Aktis intends to amend the INDs for AKY-2519 and AKY-1189 to include the in-house facility as a manufacturer of clinical supply for its ongoing clinical trials.
  

Anticipated milestones for the next 12 months

• AKY-1189: Expect preliminary data from the ongoing Phase 1b NECTINIUM-2 trial in the first quarter of 2027.
• AKY-2519: Expect preliminary data from the ongoing Phase 1b BActinium-1 trial in 2027.
• Early pipeline: Two programs tracking toward development candidate nomination and commencement of IND-enabling activities in the first quarter of 2027.
• Corporate: Expect to expand drug supply to include our in-house GMP facility to support ongoing clinical trials in the first half of 2027.

Third quarter 2026 financial results

• Cash position: Cash, cash equivalents, and marketable securities were $492.9 million as of September 30, 2026, compared with $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 September 30, 2026, are expected to fund the Company’s operating plan into 2029.
• Collaboration revenue: Collaboration revenue was $3.9 million for the quarter ended September 30, 2026, compared with $1.6 million for the comparable prior-year period. The increase of $2.3 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 $32.1 million for the quarter ended September 30, 2026, compared with $16.5 million for the comparable prior-year period. The increase of $15.6 million was primarily driven by the advancement of clinical trials for AKY-1189 and AKY-2519 and increased headcount primarily in clinical development and manufacturing to support the advancement of the clinical pipeline.
• G&A expenses: General and administrative expenses were $6.5 million for the quarter ended September 30, 2026, compared with $3.3 million for the comparable prior-year period. The increase of $3.2 million was primarily due to increased headcount to support company growth and increased activities associated with operating as a public company.
• Net loss: Net loss was $29.9 million for the quarter ended September 30, 2026, compared with $15.5 million for the comparable prior-year period. The increase of $14.4 million was primarily driven by higher operating expenses, partially offset by increased collaboration revenue recognized and interest income, net.
  

PLUVICTO® (lutetium Lu 177 vipivotide tetraxetan) is a registered trademark of Novartis Pharmaceuticals Corporation.

About NECTINIUM-2
The Phase 1b multicenter, open-label clinical trial is evaluating AKY-1189 in patients with locally advanced or mUC, breast cancer and other Nectin-4 expressing tumors. The trial will explore up to 5 dose levels in the dose escalation. Per protocol, Aktis has the ability to expand enrollment in backfill cohorts at selected dose levels and tumor types to generate additional clinical data while dose escalation continues. The trial is being conducted in the U.S. Additional information about the trial is available at clinicaltrials.gov using the identifier NCT07020117.

About BActinium-1
The Phase 1b multicenter, open-label clinical trial is evaluating AKY-2519 in patients with mCRPC, including PLUVICTO-naïve and PLUVICTO-experienced cohorts. The study will explore up to 3 dose levels in the dose escalation. Per protocol, Aktis has the ability to expand enrollment in backfill cohorts at selected dose levels to generate additional clinical data while dose escalation continues. The trial is being conducted in the U.S. Additional information about the trial is available at clinicaltrials.gov using the identifier NCT07581184.

About BActinium-2
The Phase 1b multicenter, open-label trial is evaluating AKY-2519 in patients with NSCLC and other B7-H3 expressing solid tumors. The study will explore up to 3 dose levels in the dose escalation. Per protocol, Aktis has the ability to expand enrollment at selected dose levels and tumor types to generate additional clinical data while dose escalation continues. The trial is being conducted in the U.S. Additional information about the trial is available at clinicaltrials.gov using the identifier NCT07887971.

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 and results of ongoing and planned clinical trials and regulatory filings, goals to develop and commercialize its product candidates, and other statements identified by words such as “could,” “expects,” “intends,” “may,” “plans,” “potential,” “should,” “will,” “would,” or similar expressions and the negatives of those terms. Forward-looking statements are not promises or guarantees of future performance, and are subject to a variety of risks and uncertainties, many of which are beyond the Company’s control, and which could cause actual results to differ materially from those contemplated in such forward-looking statements. These factors include risks related to the commencement and completion of the Company’s ongoing and planned clinical trials, the Company’s limited operating history, its ability to generate positive clinical trial results for its product candidates and other risks inherent in clinical development, the timing and scope of regulatory approvals, changes in laws and regulations to which the Company is subject, competitive pressures, risks relating to business interruptions, and other risks set forth under the heading “Risk Factors” of the Company’s Annual Report on Form 10-K for the year ended December 31, 2025 and in subsequent filings with the Securities and Exchange Commission. The Company’s actual results could differ materially from the results described in or implied by such forward-looking statements. Forward-looking statements speak only as of the date hereof, and, except as required by law, the Company undertakes no obligation to update or revise these forward-looking statements.

AKTIS ONCOLOGY, INC.
CONDENSED CONSOLIDATED STATEMENT OF OPERATIONS
(In thousands)
(Unaudited)
		Three Months Ended September 30,						Nine Months Ended September 30,
		2026			2025			2026			2025
Revenue:
Collaboration revenue	$	3,905		$	1,579		$	10,516		$	4,627
Operating expenses:
Research and development		32,125			16,467			77,441			50,958
General and administrative		6,527			3,315			19,427			10,978
Total operating expenses		38,652			19,782			96,868			61,936
Loss from operations		(34,747)			(18,203)			(86,352)			(57,309)
Other income (expense):
Interest income		4,822			2,682			13,971			8,761
Other expense, net		(14)			(12)			(27)			(45)
Total other income, net		4,808			2,670			13,944			8,716
Net loss	$	(29,939)		$	(15,533)		$	(72,408)		$	(48,593)

AKTIS ONCOLOGY, INC. BALANCE SHEET DATA (In thousands) (Unaudited)
	September 30,	December 31,
	2026	2025
Cash, cash equivalents, and marketable securities	$             492,929	$             226,787
Total assets	532,484	264,885
Total liabilities	73,612	77,625
Total stockholders' equity and redeemable convertible preferred stock	$             458,872	$             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

FAQ

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

What were Aktis Oncology's third-quarter 2026 financial results?

Aktis reported $3.905 million in collaboration revenue and a $29.939 million net loss for the quarter ended September 30, 2026. The comparable prior-year figures were $1.579 million in revenue and a $15.533 million net loss.

When does Aktis Oncology expect preliminary AKY-1189 and AKY-2519 clinical data?

Aktis expects preliminary AKY-1189 data in the first quarter of 2027 from NECTINIUM-2 and preliminary AKY-2519 data in 2027 from BActinium-1. Both studies are Phase 1b trials, with dose escalation ongoing.

How is Aktis Oncology expanding enrollment in NECTINIUM-2 and BActinium-1?

Aktis opened additional enrollment at selected doses to further assess safety and preliminary antitumor activity while dose escalation continues. NECTINIUM-2 began at 6 MBq for up to 30 patients; BActinium-1 began at 9 MBq for up to 30 patients per cohort. Each is the first of up to two planned dose levels for this additional enrollment in the respective patient populations.

What regulatory steps does Aktis Oncology plan for its in-house manufacturing facility?

Aktis intends to amend the investigational new drug applications for AKY-2519 and AKY-1189 to include its in-house facility as a manufacturer of clinical supply. The facility is part of its hybrid sourcing manufacturing strategy.