Aktis Oncology, Inc.: Q1 FY2026 earnings call

What management said about Q1 FY2026, from the documents filed with the SEC on 11 May 2026: press release. Guidance figures: 2 new, 4 kept. The quarter’s numbers.

Key takeaways

Net loss widened on higher operating costs: Net loss was $18.3 million, up from $15.0 million a year earlier, which the company attributed mainly to increased operating expenses. Source
Two-trial strategy for AKY-2519: The two-trial approach reflects the distinct treatment patterns and clinical needs of mCRPC patients compared with other solid tumor patients, and is designed to evaluate multiple segments. Source
MCRPC Phase 1b trial started: The Phase 1b trial enrolls both PLUVICTO-naïve and PLUVICTO-experienced patients with mCRPC, with preliminary data expected in 2027. Source
AKY-1189 enrolling across six tumor types: Patients with Nectin-4 expressing tumors are enrolling in the ongoing AKY-1189 Phase 1b trial across urothelial, breast, lung, colorectal, cervical and head and neck cancers. Source
R&D expense rose to $20.0 million: Research and development expense was $20.0 million, against $15.9 million a year earlier, an increase of $4.1 million. Source
Cash rose to $538.5 million: Cash, cash equivalents and marketable securities were $538.5 million at March 31, 2026, a change of $311.7 million from the December 31, 2025 balance. Source

“We continue to build momentum toward delivering a new class of radiopharmaceuticals targeting tumor types with large patient populations, leveraging our differentiated miniprotein radioconjugate platform and patient-first end-to-end supply chain,”
Matthew Roden, Ph.D., President and Chief Executive Officer of Aktis Oncology

Guidance

Area	Period	Figure	Against last quarter
Liquidity Source	Into 2029	into 2029	Kept
AKY-1189 clinical data Source	First quarter 2027	first quarter 2027	Kept
AKY-2519 clinical data (mCRPC) Source	2027	2027	New
AKY-2519 basket trial Source	Second half 2026	second half of 2026	New
Early pipeline Source	First quarter 2027	first quarter 2027	Kept
Manufacturing	Second half 2026	operational in the second half of 2026	Kept

What changed from last quarter

New guidance: Preliminary data timing of 2027 was given for the Phase 1b mCRPC trial of AKY-2519. The prior release gave no data timing for this trial. Source
New: Management announced a two-trial clinical development strategy for AKY-2519, covering mCRPC and a basket of other solid tumors. Source
New guidance: A second Phase 1b basket trial of AKY-2519 in lung, colorectal and other solid tumors is planned for the second half of 2026. Source
New: The Phase 1b mCRPC trial of AKY-2519 was reported as initiated. The prior release had expected a Phase 1b start in mid-2026. Source
New: Glenn Gormley, MD, PhD was appointed independent director and co-chair of the newly established Science and Technology Committee. Source

Results and revenue

Net loss widened on higher operating costs: Net loss was $18.3 million, up from $15.0 million a year earlier, which the company attributed mainly to increased operating expenses. Source
Collaboration revenue rose on Lilly work: Collaboration revenue was $3.2 million, up $1.8 million, attributed to continued advancement of the research collaboration with Eli Lilly and Company. Source
Lilly collaboration scope described: The Lilly discovery collaboration uses Aktis’ miniprotein platform to develop radioconjugates outside the company’s proprietary pipeline. Source

AKY-2519 clinical strategy

Two-trial strategy for AKY-2519: The two-trial approach reflects the distinct treatment patterns and clinical needs of mCRPC patients compared with other solid tumor patients, and is designed to evaluate multiple segments. Source
MCRPC Phase 1b trial started: The Phase 1b trial enrolls both PLUVICTO-naïve and PLUVICTO-experienced patients with mCRPC, with preliminary data expected in 2027. Source
Second platform program reached clinic: Management said AKY-2519 is the second program advanced from the platform to the clinic in the last twelve months, following AKY-1189. Source

“This is the first of two trials in our clinical development strategy designed to expand the breadth of tumors studied and augment speed to data, with preliminary data from the mCRPC trial anticipated in 2027.”
Matthew Roden, Ph.D., President and Chief Executive Officer of Aktis Oncology

AKY-1189 clinical progress

AKY-1189 enrolling across six tumor types: Patients with Nectin-4 expressing tumors are enrolling in the ongoing AKY-1189 Phase 1b trial across urothelial, breast, lung, colorectal, cervical and head and neck cancers. Source
Fast Track designation for urothelial cancer: The FDA granted Fast Track designation for AKY-1189 in urothelial cancer after prior systemic therapies. The prior release dated the designation to February 2026. Source
AKY-1189 Phase 1b trial began 2025: Costs of the AKY-1189 Phase 1b trial were cited as a driver of R&D expense, with the trial having begun in the second quarter of 2025. Source

Operating costs

R&D expense rose to $20.0 million: Research and development expense was $20.0 million, against $15.9 million a year earlier, an increase of $4.1 million. Source
AKY-2519 studies added to R&D: Increased R&D spending also reflected advancing AKY-2519 through IND-enabling studies, together with employee-related costs from increased hiring. Source
G&A rose on hiring and public company costs: G&A expense was $5.9 million, up $2.2 million, mainly from higher employee-related costs and expenses of operating as a public company. Source

“We remain focused on generating clinical data intended to support advancement of both programs and maximizing the potential clinical benefit for patients.”
Matthew Roden, Ph.D., President and Chief Executive Officer of Aktis Oncology

Cash and capital

Cash rose to $538.5 million: Cash, cash equivalents and marketable securities were $538.5 million at March 31, 2026, a change of $311.7 million from the December 31, 2025 balance. Source
IPO raised $365.4 million gross: The January 2026 offering covered 20,297,500 shares including the underwriters' option, at $18.00 per share, for gross proceeds of about $365.4 million before discounts and expenses. Source
Cash increase tied to IPO proceeds: Management attributed the cash increase mainly to net IPO proceeds, partly offset by cash used in operations. Source

Platform, manufacturing and early pipeline

Platform described as isotope-agnostic: Management describes the miniprotein radioconjugate platform as isotope-agnostic, designed for high tumor penetration and imaging before therapeutic dosing. Source
In-house GMP facility under construction: The in-house GMP facility is expected to be operational in the second half of 2026, supporting clinical supply demand under a hybrid manufacturing strategy. Source
Two early programs toward candidate nomination: Two early-pipeline programs are tracking toward development candidate nomination, with IND-enabling activities expected to start in the first quarter of 2027. Source

Coming up, as management said on 11 May 2026

AKY-2519 basket trial starts: A Phase 1b basket trial in lung, colorectal and other B7-H3 expressing solid tumors is planned to start in the second half of 2026. Source
ASCO imaging data presentation: AKY-2519 imaging and dosimetry data will be presented at ASCO, May 29 to June 2, 2026, in Chicago. The data cover initial biodistribution and predicted absorbed doses. Source
AKY-1189 preliminary data: Preliminary data from the AKY-1189 Phase 1b trial are expected in the first quarter of 2027. Source
AKY-2519 mCRPC preliminary data: Preliminary data from the Phase 1b mCRPC trial of AKY-2519 are expected in 2027. Source

Figures management reported

Figure	Reported
R&D expenses Source	$20.0 million in Q1 2026, against $15.9 million in Q1 2025
Regulatory designation Source	Fast Track designation for AKY-1189 in locally advanced or metastatic urothelial cancer
IND clearance Source	FDA cleared IND applications for AKY-2519 Phase 1b trial
Pipeline milestones Source	AKY-1189 Phase 1b preliminary data expected Q1 2027; AKY-2519 mCRPC preliminary data expected 2027

Earlier plans management reported on

Met: The prior release expected the Phase 1b start in mid-2026. This release reports the mCRPC trial was initiated.
Not stated: The prior release expected imaging and dosimetry results in mid-2026. This release states the data are accepted for presentation at ASCO, May 29 to June 2, 2026.
On track: Management states the two early programs are tracking toward candidate nomination and IND-enabling activities in the first quarter of 2027. Source
Not stated: The prior release expected the GMP facility to be operational in the second half of 2026. This release keeps that timing.
Not stated: The prior release expected preliminary data from Part 1 of the Phase 1b trial in the first quarter of 2027. This release keeps that timing.

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 First Quarter 2026

Announced two-trial clinical development strategy for AKY-2519 enabling evaluation in multiple patient segments

Initiated Phase 1b clinical trial of AKY-2519 in metastatic castration-resistant prostate cancer (mCRPC); expect preliminary data in 2027

Announced AKY-2519 clinical imaging and dosimetry data presentation at upcoming 2026 ASCO Annual Meeting

Enrolling patients with Nectin-4 expressing tumors in ongoing Phase 1b clinical trial of AKY-1189; expect preliminary data in first quarter 2027

BOSTON, May 11, 2026 (GLOBE NEWSWIRE) -- Aktis Oncology, Inc. (NASDAQ:AKTS) (Aktis or the Company), a clinical-stage oncology company focused on expanding the breakthrough potential of targeted radiopharmaceuticals to large populations, including those not addressed by existing platform technologies, today reported financial results and business highlights for the first quarter ended March 31, 2026.

"We continue to build momentum toward delivering a new class of radiopharmaceuticals targeting tumor types with large patient populations, leveraging our differentiated miniprotein radioconjugate platform and patient-first end-to-end supply chain,” said Matthew Roden, Ph.D., President and Chief Executive Officer of Aktis Oncology. “Last week, we announced the initiation of our Phase 1b clinical trial of AKY-2519 in patients with mCRPC. This is the first of two trials in our clinical development strategy designed to expand the breadth of tumors studied and augment speed to data, with preliminary data from the mCRPC trial anticipated in 2027. We plan to initiate a second Phase 1b basket trial of AKY-2519 in additional solid tumors in the second half of this year. We also look forward to presenting our first AKY-2519 clinical imaging and dosimetry data for AKY-2519 at ASCO, which informed our clinical development strategy.”

Dr. Roden continued, “AKY-2519 marks the second program we have advanced from our proprietary miniprotein radioconjugate platform to the clinic in the last twelve months. In parallel, we continue to enroll patients in our ongoing Phase 1b trial of AKY-1189 targeting Nectin-4 expressing tumors, with preliminary data expected in the first quarter of 2027. We remain focused on generating clinical data intended to support advancement of both programs and maximizing the potential clinical benefit for patients.”

Q1 and recent business highlights

AKY-1189 highlights

AKY-1189 is a novel, clinical-stage miniprotein radioconjugate designed to selectively deliver actinium-225 (Ac) to Nectin-4 expressing tumors.

Received Fast Track designation from the U.S. Food and Drug Administration (FDA) for AKY-1189 for the treatment of adult patients with locally advanced or metastatic urothelial cancer (mUC) who have progressed on or after prior systemic therapies.

Enrolling patients in the ongoing Phase 1b clinical trial of AKY-1189 in patients with locally advanced or mUC, breast cancer, non-small cell lung cancer, colorectal cancer, cervical cancer, and head and neck cancer.

Expect to report preliminary data from the Phase 1b trial in the first quarter of 2027.

AKY-2519 highlights

AKY-2519 is a novel, clinical-stage miniprotein radioconjugate designed to selectively deliver Ac to B7-H3 expressing tumors, including prostate, lung, and other solid tumors.

Received FDA clearance for the Company’s Investigational New Drug (IND) applications to proceed to a Phase 1b clinical trial with AKY-2519.

Announced two-trial clinical development strategy for AKY-2519, which was informed by insights from the Company’s clinical advisory boards and reflects the distinct treatment patterns and clinical needs of patients with mCRPC compared to other solid tumor patients. This strategy is designed to enable the broad evaluation of AKY-2519 in multiple patient segments while efficiently generating indication-relevant data.

Initiated Phase 1b, multicenter, open label clinical trial of AKY-2519 in PLUVICTO®-naïve and PLUVICTO-experienced patients with mCRPC.

Plan to initiate a Phase 1b basket trial in patients with lung, colorectal, and other B7-H3 expressing solid tumors in the second half of 2026. The protocol for this trial has been finalized and is currently under regulatory review.

Announced clinical imaging and dosimetry data for AKY-2519 has been accepted for presentation at the upcoming American Society of Clinical Oncology (ASCO) Annual Meeting being held May 29 - June 2, 2026, in Chicago. The data facilitate initial understanding of AKY-2519 biodistribution and predicted absorbed doses in tumors and normal tissues in patients with B7-H3 expressing solid tumors.

General corporate highlights

Appointed industry veteran Glenn Gormley, MD, PhD as an independent director to the Company’s Board of Directors (Board) and as co-chair of the Board’s newly established Science and Technology Committee.

In January 2026, completed an initial public offering of 20,297,500 shares of common stock, including the exercise in full by the underwriters of their option to purchase an additional 2,647,500 shares of common stock, at $18.00 per share, resulting in gross proceeds of approximately $365.4 million, before deducting underwriting discounts and commissions and other offering expenses.

Anticipated pipeline and corporate milestones for the next 12 months

AKY-1189: Expect preliminary data from the ongoing Phase 1b clinical trial in the first quarter of 2027.

AKY-2519:

Will present clinical imaging and dosimetry data of AKY-2519 in patients with mCRPC and various solid tumors at the upcoming ASCO Annual Meeting.

Expect to commence Phase 1b basket trial in lung, colorectal, and other solid tumor cancers in the second half of 2026.

Expect preliminary data from the Phase 1b mCRPC clinical trial in 2027.

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

Early pipeline: Two programs are tracking toward development candidate nomination and commencement of IND-enabling activities in the first quarter of 2027.

Corporate: In-house Good Manufacturing Practices (GMP) facility expected to be operational in the second half of 2026 as part of the Company’s hybrid manufacturing strategy to expand capabilities and support clinical supply demand.

First quarter 2026 financial results

Cash position: Cash, cash equivalents and marketable securities were $538.5 million as of March 31, 2026, compared to $226.8 million as of December 31, 2025. The increase of $311.7 million primarily reflects net proceeds from the Company’s initial public offering in January 2026, primarily offset by cash used in operations. The Company’s cash, cash equivalents and marketable securities as of March 31, 2026 are expected to fund its operations into 2029.

Collaboration revenue: Collaboration revenue was $3.2 million for the quarter ended March 31, 2026, compared to $1.4 million for the comparable prior year period. The increase of $1.8 million was attributable to continued advancement of the Company’s research collaboration with Eli Lilly and Company, with revenue recognized over time using the cost incurred input method.

R&D expenses: Research and development expenses were $20.0 million for the quarter ended March 31, 2026, compared to $15.9 million for the comparable prior year period. The increase of $4.1 million was primarily driven by Phase 1b clinical trial expenses for AKY-1189, which initiated in the second quarter of 2025, increased expenses with advancing AKY-2519 through IND-enabling studies, and increased employee-related costs (including stock-based compensation) associated with increased hiring to support the advancing clinical pipeline.

G&A expenses: General and administrative expenses were $5.9 million for the quarter ended March 31, 2026, compared to $3.7 million for the comparable prior year period. The increase of $2.2 million was primarily due to higher employee-related costs (including stock-based compensation) related to increased hiring to support the Company’s growth, and increased expenses associated with operating as a public company.

Net loss: Net loss was $18.3 million for the quarter ended March 31, 2026, compared to $15.0 million for the comparable prior year period. The increase in net loss of $3.3 million was primarily driven by increased operating expenses.

About Aktis’ miniprotein radioconjugate platform

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

About Aktis Oncology

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

Forward-looking statements

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 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.

AKTIS ONCOLOGY, INC.

CONDENSED CONSOLIDATED STATEMENT OF OPERATIONS

(In thousands, except shares and par value data)

(Unaudited)

	Three Months Ended March 31,
	2026	2025
Revenue:
Collaboration revenue	$3,227	$1,447
Operating expenses:
Research and development	20,036	15,863
General and administrative	5,897	3,727
Total operating expenses	25,933	19,590
Loss from operations	(22,706)	(18,143)
Other income (expense):
Interest income	4,384	3,171
Other expense, net	(3)	(13)
Total other income, net	4,381	3,158
Net loss	$(18,325)	$(14,985)

AKTIS ONCOLOGY, INC.

BALANCE SHEET DATA

(In thousands, except shares and par value data)

(Unaudited)

	March 31,	December 31,
	2026	2025
Cash, cash equivalents and marketable securities	$538,484	$226,787
Total assets	576,801	264,885
Total liabilities	70,693	77,625
Total stockholders' equity (deficit) and redeemable convertible preferred stock	$506,108	$187,260

Media contact: Melone Communications, LLC Liz Melone

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Investor contact: Precision AQ

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