Aktis Oncology, Inc.: Q2 FY2026 earnings call

What management said about Q2 FY2026, from the documents filed with the SEC on 13 August 2026: press release. Guidance figures: 6 kept. The quarter’s numbers.

Key takeaways

Net loss widened to $24.1 million: The company reported a net loss of $24.1 million for the quarter ended June 30, 2026, compared with $18.1 million a year earlier. Source
ASCO imaging data presented for AKY-2519: First-in-human AKY-2519 imaging and dosimetry data were presented at ASCO in May 2026, reporting tumor uptake and retention with limited normal tissue exposure. Source
BActinium-2 basket trial cleared: Regulatory review has been cleared for the Phase 1b BActinium-2 trial in various other B7-H3 expressing tumors, after the protocol was under review in the first quarter. Source
NECTINIUM-2 enrollment continues: The company continued to enroll patients in the Phase 1b NECTINIUM-2 trial of AKY-1189 in locally advanced or metastatic urothelial cancer, breast cancer and other Nectin-4 tumors. Source
R&D expense rose to $25.3 million: Research and development expense was $25.3 million, against $18.6 million a year earlier, with the increase tied to AKY-1189 Phase 1b operations and AKY-2519 studies. Source
Cash position reached $517.3 million: Cash, cash equivalents and marketable securities were $517.3 million at June 30, 2026, up from $226.8 million at December 31, 2025. Source
In-house GMP facility in hybrid strategy: The company is operationalizing an internal GMP facility as part of a hybrid manufacturing strategy, to enable its own clinical supply for the pipeline. Source

“This was a quarter of strong execution for Aktis, focused on generating clinical data and building infrastructure to support our clinical pipeline”
Matthew Roden, Ph.D., President and Chief Executive Officer of Aktis Oncology

Guidance

Area	Period	Figure	Against last quarter
Cash runway Source	into 2029	into 2029	Kept
AKY-1189 preliminary data Source	first quarter 2027	first quarter of 2027	Kept
AKY-2519 mCRPC preliminary data Source	2027	2027	Kept
BActinium-2 basket trial start Source	second half of 2026	second half of 2026	Kept
Early pipeline candidate nomination Source	first quarter 2027	first quarter of 2027	Kept
In-house GMP facility Source	second half of 2026	second half of 2026	Kept

What changed from last quarter

New: The BActinium-2 basket trial protocol, previously under regulatory review, has cleared regulatory review and is cleared to start. Source
Ended: The first quarter release listed colorectal among the basket trial tumor types; the second quarter release names lung and other B7-H3 tumors without colorectal.

Quarter results and net loss

Net loss widened to $24.1 million: The company reported a net loss of $24.1 million for the quarter ended June 30, 2026, compared with $18.1 million a year earlier. Source
Interest income offset part of costs: Management attributed the net loss increase to higher operating expenses, offset by interest income of $4.8 million in the quarter. Source
Net loss up from first quarter: The first quarter 2026 net loss was $18.3 million, per the earlier release, compared with $24.1 million in the second quarter.

AKY-2519 clinical program

ASCO imaging data presented for AKY-2519: First-in-human AKY-2519 imaging and dosimetry data were presented at ASCO in May 2026, reporting tumor uptake and retention with limited normal tissue exposure. Source
Phase 1b mCRPC trial enrolling: The BActinium-1 Phase 1b trial in PLUVICTO-naive and PLUVICTO-experienced patients with mCRPC is enrolling patients. Source
BActinium-2 basket trial cleared: Regulatory review has been cleared for the Phase 1b BActinium-2 trial in various other B7-H3 expressing tumors, after the protocol was under review in the first quarter. Source

“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.”
Matthew Roden, Ph.D., President and Chief Executive Officer of Aktis Oncology

AKY-1189 clinical program

NECTINIUM-2 enrollment continues: The company continued to enroll patients in the Phase 1b NECTINIUM-2 trial of AKY-1189 in locally advanced or metastatic urothelial cancer, breast cancer and other Nectin-4 tumors. Source
Nectin-4 target profile described: The company describes Nectin-4 as a clinically and commercially validated target expressed in several tumor types, including urothelial and breast. Source
Named indications generalized to other tumors: The first quarter release named non-small cell lung, colorectal, cervical and head and neck cancers in the NECTINIUM-2 trial; the second quarter release refers to other Nectin-4 tumors.

Collaboration revenue and Lilly

Lilly collaboration revenue rose $1.8 million: Collaboration revenue increased by $1.8 million, attributed to continued advancement of the research collaboration with Eli Lilly, recognized over time using the cost incurred input method. Source
Revenue higher than first quarter: Collaboration revenue was $3.2 million in the first quarter 2026, so the second quarter figure of $3.4 million is higher than the prior quarter.
Discovery collaboration outside the pipeline: The company described a discovery collaboration with Eli Lilly to develop radioconjugates outside its proprietary pipeline, using its miniprotein platform. Source

“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.”
Matthew Roden, Ph.D., President and Chief Executive Officer of Aktis Oncology

Operating costs

R&D expense rose to $25.3 million: Research and development expense was $25.3 million, against $18.6 million a year earlier, with the increase tied to AKY-1189 Phase 1b operations and AKY-2519 studies. Source
R&D expense up from first quarter: Research and development expense was $20.0 million in the first quarter 2026, lower than the $25.3 million reported for the second quarter.
G&A rose on hiring and public-company costs: General and administrative expense rose to $7.0 million from $3.9 million, mainly from employee-related costs tied to hiring and expenses of operating as a public company. Source

Cash and balance sheet

Cash position reached $517.3 million: Cash, cash equivalents and marketable securities were $517.3 million at June 30, 2026, up from $226.8 million at December 31, 2025. Source
IPO proceeds drove the increase: The company attributed the cash increase to net proceeds from its January 2026 initial public offering, primarily offset by cash used in operations. Source
Equity increased from year-end: Total stockholders' equity and redeemable convertible preferred stock was $484,838 thousand at June 30, 2026, against $187,260 thousand at December 31, 2025. Source

Manufacturing and platform

In-house GMP facility in hybrid strategy: The company is operationalizing an internal GMP facility as part of a hybrid manufacturing strategy, to enable its own clinical supply for the pipeline. Source
Platform described as isotope-agnostic: The company describes its miniprotein radioconjugate platform as proprietary and isotope-agnostic, with imaging isotopes used to verify target engagement before therapy. Source
Two early programs near candidate nomination: Two early pipeline programs are tracking toward candidate nomination and IND-enabling work, planned for the first quarter of 2027. Source

Coming up, as management said on 13 August 2026

AKY-1189 preliminary data: Preliminary data from the ongoing Phase 1b NECTINIUM-2 trial of AKY-1189 are expected in the first quarter of 2027. Source
BActinium-2 basket trial start: The company expects to commence the BActinium-2 basket trial of AKY-2519 in lung and other B7-H3 tumors in the second half of 2026. Source
AKY-2519 mCRPC preliminary data: Preliminary data from the Phase 1b mCRPC trial of AKY-2519 are expected in 2027. Source
Early pipeline candidate nomination: Two early programs are tracking toward development candidate nomination and the start of IND-enabling activities in the first quarter of 2027. Source
In-house GMP facility operational: The in-house GMP facility is expected to be operational in the second half of 2026 under the hybrid manufacturing strategy. Source

Figures management reported

Figure	Reported
R&D expense, three months ended June 30, 2026 Source	$25.3 million
Phase 1b trials enrolling Source	NECTINIUM-2 (AKY-1189) and BActinium-1 (AKY-2519)

Earlier plans management reported on

On track: Management said the company is on track to initiate the AKY-2519 trial in other B7-H3 solid tumors, including lung cancers, in the second half of 2026. Source
Met: The company reported that the AKY-2519 imaging and dosimetry data were presented at the ASCO Annual Meeting in May 2026, as planned in the first quarter release. Source

Other quarters

Summarised with AI from the documents the company filed with the SEC. Every point is checked against the filing before it is shown: management’s own words word for word, figures against the line or table row they come from. A point that fails the check is left out. Source opens the filing at that line.

As filed with the SEC

Open the filing on EDGAR

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 (Ac) 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 Ac 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.

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.

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:

Expect preliminary data from the ongoing Phase 1b NECTINIUM-2 clinical trial in the first quarter of 2027.

AKY-2519:

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.

Expect preliminary data from Phase 1b mCRPC clinical 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:

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

$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

Forward-looking statements notice

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.

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)

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