Form 8-K

8-K — uniQure N.V.

Accession: 0001104659-26-055242

Filed: 2026-05-05

Period: 2026-05-05

CIK: 0001590560

SIC: 2834 (PHARMACEUTICAL PREPARATIONS)

Item: Results of Operations and Financial Condition

Item: Financial Statements and Exhibits

Documents

8-K — qure-20260505x8k.htm (Primary)

EX-99.1 (qure-20260505xex99d1.htm)

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8-K

8-K (Primary)

Filename: qure-20260505x8k.htm · Sequence: 1

uniQure N.V._May 5, 2026

000159056000-0000000false00015905602026-05-052026-05-05

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): May 5, 2026

uniQure N.V.

(Exact Name of Registrant as Specified in Charter)

The Netherlands

001-36294

N/A

(State or Other

Jurisdiction of Incorporation)

(Commission

File Number)

(IRS Employer

Identification No.)

Paasheuvelweg 25a,

1105 BP Amsterdam, The Netherlands

N/A

(Address of Principal Executive Offices)

(Zip Code)

Registrant’s telephone number, including area code: +31-20-240-6000

(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 (see General Instruction A.2. below):

☐ 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:

Ordinary Shares, par value €0.05 per share

QURE

The Nasdaq Stock Market LLC

The Nasdaq Global Select Market

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 May 5, 2026, uniQure N.V. (the “Company”) issued a press release announcing its financial results for the quarter ended March 31, 2026 and providing a corporate update. A copy of the press release is furnished as Exhibit 99.1 to this Current Report on Form 8-K and is incorporated herein by reference.

The information provided in this Item 2.02, including the accompanying Exhibit 99.1, shall be deemed “furnished” and shall not be deemed “filed” for the purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liability of such section, nor shall it be incorporated by reference in any filing made by the Company pursuant to the Securities Act of 1933, as amended, or the Exchange Act, regardless of the general incorporation language of such filing, except to the extent that such filing incorporates by reference any or all of such information by express reference.

Item 9.01 Financial Statements and Exhibits.

(d) Exhibits.

Exhibit No.

Description

99.1

Press Release of uniQure N.V. regarding its financial results dated May 5, 2026

104

Cover Page Interactive Data File (embedded with the Inline XBRL document).

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.

UNIQURE N.V.

Date: May 5, 2026

By:

/s/ CHRISTIAN KLEMT

Christian Klemt

Chief Financial Officer

EX-99.1

Filename: qure-20260505xex99d1.htm · Sequence: 2

Exhibit 99.1

uniQure Announces First Quarter 2026 Financial Results and Provides Recent Company

Updates

~ Advancing FDA interactions on AMT-130 for Huntington’s disease; Type B meeting scheduled for the second quarter of 2026 ~

~ Progressing AMT-130 toward expected UK regulatory submission; MAA on track for third quarter of 2026 following successful pre-submission meeting with UK MHRA~

~ Enrollment in AMT-260 temporal lobe epilepsy program on track; clinical update from first cohort in Phase I/IIa study to be presented at the Epilepsy Foundation Pipeline Conference ~

~ Presented updated data from AMT-191 Phase I/IIa in Fabry disease study showed sustained increases in α-Gal A Enzyme Activity and stable Lyso-Gb3 levels; subsequently all 11 dosed patients have discontinued enzyme replacement therapy ~

~ Strong balance sheet with $586.6 million in cash, cash equivalents and current investment securities as of March 31, 2026 and runway into the second half of 2029 ~

~ uniQure to host earnings call at 8:30 a.m. ET ~

Lexington, MA and Amsterdam, the Netherlands, May 5, 2026 — uniQure N.V. (NASDAQ: QURE), a leading gene therapy company advancing transformative therapies for patients with severe medical needs, today reported its financial results for the first quarter of 2026 and highlighted recent progress across its business.

“During the first quarter of 2026, we remained focused on advancing AMT-130 to patients globally as rapidly as possible while executing across our broader pipeline,” said Matthew Kapusta, chief executive officer at uniQure. “We believe our data continue to support the potential for AMT-130 to fundamentally change the treatment landscape for Huntington’s disease, and we look forward to continued engagement with the FDA. In parallel, following a constructive interaction with the MHRA, we are preparing to submit an MAA in the third quarter and evaluating additional international opportunities.”

“We expect to deliver key clinical updates throughout 2026, including data from our AMT-260 program in refractory mesial temporal lobe epilepsy later in the second quarter and four-year AMT-130 data analysis in the third quarter,” Mr. Kapusta continued. “With these important milestones ahead, we remain committed to advancing our programs with urgency while maintaining disciplined capital allocation to drive long-term shareholder value.”

Recent Company Developments and Updates

Advancing AMT-130 for the treatment of Huntington’s disease

● The Company held a Type A meeting with the U.S. Food and Drug Administration (FDA) in January 2026 to discuss the regulatory path forward following an October 2025 pre-Biologics License Application (BLA) meeting. Following receipt of final meeting minutes from the Type A meeting, the Company announced that the FDA stated it cannot agree that data from the Phase

I/II studies, compared to an external control, are sufficient to provide the primary evidence of effectiveness required to support a marketing application for AMT-130.

● The Company has been granted a Type B meeting with the FDA and plans to discuss key elements of a potential new clinical trial design and to solicit feedback on the proposed statistical analysis plan for the four-year data expected in the third quarter of 2026.

● Following a constructive pre-submission meeting with the United Kingdom’s (UK) Medicines and Healthcare products Regulatory Agency (MHRA), the Company expects to submit a Marketing Authorization Application (MAA) for AMT-130 based on three-year data in the third quarter of 2026.

Continued clinical progress in pipeline programs

AMT-260 for the treatment of refractory mesial temporal lobe epilepsy (MTLE)

● In 2025, the Company completed enrollment in the first dose cohort of six patients in the Phase I/IIa study. Enrollment is ongoing in a second dose cohort, expected to include an additional six patients. Enrollment of the second cohort is expected to be completed in mid-2026.

● The Company expects to provide data from the first cohort of six patients in the Phase I/IIa study with up to six months of follow-up at the Epilepsy Foundation Pipeline Conference, June 18 -19, 2026.

AMT-191 for the treatment of Fabry disease

● In February 2026, the Company presented updated safety and exploratory efficacy data from the Phase I/II study of AMT-191 in Fabry disease (data cutoff as of January 8, 2026):

o Dose-dependent elevations were observed across 11 patients in three dose levels with α-Gal A activity ranging from 0.34- to 82.2-fold above mean normal range1 at the lowest dose, 1.6- to 312.5-fold at the mid dose, and 27.7- to 223.7-fold at the highest dose. These increases were durable across follow-up periods ranging from four months to more than one year.

o Plasma lyso-Gb3 levels were stable post-dose across all cohorts, regardless of enzyme replacement therapy (ERT) status.

● As of February 18, 2026, all 11 dosed patients were withdrawn from ERT.

● AMT-191 continued to show a manageable safety profile at all dose levels. No SAEs related to AMT-191 were observed at the 4x1013 gc/kg and 2x1013 gc/kg doses. No additional SAEs were observed at the 6x1013 gc/kg dose beyond the five previously reported in September 2025 in two patients.

● Per protocol, additional dosing in the mid- and high-dose cohorts has been paused pending further evaluation of asymptomatic Grade 3 liver enzyme elevations reported in two patients from the mid-dose cohort, which were confirmed as dose-limiting toxicities.

1 Normal range (1.38 – 8.66 nmol); mean normal of 3.57 nmol

AMT-162 for the treatment of SOD1 amyotrophic lateral sclerosis (ALS)

● In 2025, the Company voluntarily paused enrollment in the Phase I/II EPISOD1 multi-center, open-label U.S. trial of AMT-162 for the treatment of SOD1-ALS, following an Independent Data Monitoring Committee review of available preliminary safety and efficacy data, including a SAE determined to be a dose-limiting toxicity observed in one patient in the second cohort. Following review of the preliminary efficacy and safety data generated from EPISOD1, the decision was made to discontinue development of AMT-162. Safety data will continue to be collected from the five patients dosed in EPISOD1, consistent with applicable safety and regulatory requirements.

Focused execution and strong financial position

● In April 2026, uniQure, CSL Behring and Genezen entered into agreements under which uniQure’s remaining HEMGENIX® supply and any minimum purchase commitments will terminate after delivery of contractually specified batches to CSL Behring, which uniQure expects to occur in mid-2026. Concurrently, CSL Behring entered into a direct relationship with Genezen as the supplier of HEMGENIX®. These agreements have no impact on future royalties or milestones to uniQure under the license agreement with CSL Behring.

● As of March 31, 2026, the Company had cash, cash equivalents and current investment securities of $586.6 million. The Company expects that cash, cash equivalents and investment securities will be sufficient to fund operations into the second half of 2029.

Financial Highlights

Cash Position: As of March 31, 2026, the Company held $586.6 million in cash, cash equivalents and current investment securities, compared to $622.5 million as of December 31, 2025. The Company expects that cash, cash equivalents and investment securities will be sufficient to fund operations into the second half of 2029.

Revenues: Revenue for the three months ended March 31, 2026 was $3.6 million, compared to $1.6 million in the same period in 2025. The increase of $2.0 million is due to an increase in license revenue, compared to the prior period.

R&D Expenses: Research and development expenses were $29.2 million for the three months ended March 31, 2026, compared to $36.1 million during the same period in 2025. The $6.9 million decrease was driven by a $2.6 million decrease in the fair value of contingent consideration, a $1.2 million decrease in costs related to external program spend, a $1.6 million decrease in employee and contractor-related expenses, including share-based compensation, and a $1.6 million decrease in facilities and other expenses, compared to the prior period.

SG&A Expenses: Selling, general and administrative expenses were $20.1 million for the three months ended March 31, 2026, compared to $10.9 million during the same period in 2025. The $9.2 million increase was primarily related to a $5.5 million increase in employee and contractor-related expenses, including share-based compensation, mainly as a result of employees recruited in 2025 to support commercial planning of AMT-130, a $1.8 million increase in professional fees, a $0.6 million increase in intellectual property fees, and a $1.3 million increase in information technology costs and other expenses, compared to the prior period.

Other Income: Other income was $1.6 million for the three months ended March 31, 2026, compared to $8.3 million during the comparative period in 2025. The $6.7 million decrease was primarily related to a prior period one-time gain of $6.0 million related to the sale of critical reagents and a $0.8 million decrease in research and development grants, compared to the prior period.

Other Expense: Other expense was $1.5 million for the three months ended March 31, 2026, compared to $2.0 million during the same period in 2025. The decrease was primarily due to a $0.3 million decrease in costs associated with the supply of Hemgenix® to CSL Behring and a $0.2 million decrease in sublease expenses in the three months ended March 31, 2026, compared to the prior period.

Other non-Operating Items, net: Other non-operating items, net was an expense of $7.3 million for the three months ended March 31, 2026, compared to an expense of $3.8 million for the same period in 2025. The $3.5 million increase was primarily related to an increase in net foreign currency losses of $9.5 million, offset by a $1.1 million increase in interest income, a $1.1 million decrease in interest expense, and a $3.8 million gain resulting from changes in the fair value of the liability related to pre-funded warrants, compared to the prior period.

Net loss: The net loss for the three months ending March 31, 2026, was $53.5 million, or $0.85 basic and diluted loss per ordinary share, compared to a $43.6 million net loss for the comparative period in 2025, or $0.82 basic and diluted loss per ordinary share.

Upcoming investor events:

● 2026 RBC Capital Markets Global Healthcare Conference, May 19th – New York, NY

Investor Conference Call and Webcast Information

uniQure management will host an investor conference call and webcast today, Tuesday, May 5th at 8:30 a.m. ET. The event will be webcast under the Events & Presentations section of uniQure’s website at https://www.uniqure.com/investors-media/events-presentations, and following the event a replay will be archived for 90 days. Analysts wishing to participate in the question and answer session should access the live call by dialing (646) 307-1963 or toll-free (800) 715-9871 and entering conference ID 4607289. If you are joining the conference call, please join 15 minutes before the start time.

About uniQure

uniQure is delivering on the promise of gene therapy – single treatments with potentially curative results. The approvals of uniQure’s gene therapy for hemophilia B – an historic achievement based on more than a decade of research and clinical development – represent a major milestone in the field of genomic medicine and ushers in a new treatment approach for patients living with hemophilia. uniQure is now advancing a pipeline of proprietary gene therapies for the treatment of patients with Huntington’s disease, refractory temporal lobe epilepsy, Fabry disease, and other severe diseases. www.uniQure.com

uniQure Forward-Looking Statements

This press release contains forward-looking statements. All statements other than statements of historical fact are forward-looking statements, which are often indicated by terms such as “anticipate,” “believe,” “could,” “establish,” “estimate,” “expect,” “goal,” “intend,” “look forward to”, “may,” “plan,” “potential,” “predict,” “project,” “seek,” “should,” “will,” “would” and similar expressions. Forward-looking statements are based on management’s beliefs and assumptions and on information available to management only as of the date of this press release. Examples of these forward-looking statements include, but are not limited to, statements concerning: the Company’s cash runway and its ability to fund its operations into the second half of 2029; the Company’s ability and plans to strategically advance its programs; the Company’s plans and timing with respect to future interactions with regulatory authorities and regulatory updates related to AMT-130, including the Company’s plans to continue engaging with the FDA and have a Type B meeting regarding a potential new clinical trial design and statistical analysis plan for the four-year analysis of AMT-130, and the Company’s

plans to submit a MAA to the MHRA in the third quarter of 2026; the potential for AMT-130 to change the treatment landscape for Huntington’s disease; the Company’s plans to enroll an additional six patients in a second cohort in the Phase I/IIa study for AMT-260 by mid-2026; the Company’s plans to provide further clinical updates, including plans to announce additional data from the Company’s AMT-260 program in June 2026 and four-year data from the Company’s AMT-130 program in the third quarter of 2026; the Company’s plans to continue to collect safety data from patients in the EPISOD1 trial of AMT-162; the timing of when the Company’s HEMGENIX® supply and minimum purchase commitments are expected to terminate pursuant to agreements entered into with CSL Behring and Genezen; and the Company’s plans to attend upcoming investor events. The Company’s actual results could differ materially from those anticipated in these forward-looking statements for many reasons. These risks and uncertainties include, among others: risks associated with the clinical results and the development and timing of the Company’s programs, including the risk that clinical results will be unable to demonstrate data sufficient to support further clinical development or regulatory approval in any country where approval is pursued; the risk that more patient data become available that results in a different interpretation than the one derived from preliminary, interim or topline data; the Company’s interactions with regulatory authorities, including the FDA and MHRA, which may affect the initiation, timing and progress of clinical trials and pathways and timing for regulatory approval; whether the measurements that the Company is evaluating are viewed as robust and sensitive measurements of disease progression suitable for regulatory approval; the Company’s ability to conduct and fund a new study for AMT-130; the Company’s ability to continue to build and maintain the infrastructure and personnel needed to achieve its goals; the Company’s effectiveness in managing current and future clinical trials and regulatory processes; the continued development and acceptance of gene therapies; the Company’s ability to demonstrate the therapeutic benefits of its gene therapy candidates in clinical trials; the Company’s ability to obtain, maintain and protect intellectual property; and the Company’s ability to fund its operations. These risks and uncertainties are more fully described under the heading “Risk Factors” in the Company’s periodic filings with the U.S. Securities & Exchange Commission (“SEC”), including the Company’s Annual Reports on Form 10-K and Quarterly Reports on Form 10-Q, and in other filings that the Company makes with the SEC from time to time. Given these risks, uncertainties and other factors, you should not place undue reliance on these forward-looking statements, and the Company assumes no obligation to update these forward-looking statements, even if new information becomes available in the future.

uniQure Contacts:

FOR INVESTORS:

FOR MEDIA:

Chiara Russo

Tom Malone

Direct: 781-491-4371

Direct: 339-970-7558

Mobile: 617-306-9137

Mobile:339-223-8541

c.russo@uniQure.com

t.malone@uniQure.com

uniQure N.V.

UNAUDITED CONSOLIDATED BALANCE SHEETS

March 31,

December 31,

2026

2025

(in thousands, U.S. dollars)

Current assets

Cash and cash equivalents

139,994

80,240

Current investment securities

446,556

542,301

Accounts receivable

3,562

5,863

Prepaid expenses

16,589

20,506

Other current assets and receivables

9,043

7,076

Total current assets

615,744

655,986

Non-current assets

Property, plant and equipment, net

12,014

13,800

Other investments

30,150

30,237

Operating lease right-of-use assets

12,261

12,525

Intangible assets, net

69,990

72,790

Goodwill

24,811

25,355

Deferred tax assets, net

8,194

8,654

Other non-current assets

5,542

5,561

Total non-current assets

162,962

168,922

Total assets

778,706

824,908

Current liabilities

Accounts payable

4,399

5,170

Accrued expenses and other current liabilities

43,201

41,292

Liability related to pre-funded warrants

8,605

12,595

Current portion of operating lease liabilities

2,992

3,862

Total current liabilities

59,197

62,919

Non-current liabilities

Long-term debt

49,942

49,699

Liability from royalty financing agreement

482,334

473,199

Operating lease liabilities, net of current portion

10,388

9,832

Contingent consideration

17,029

18,736

Deferred tax liability, net

7,796

7,967

Other non-current liabilities, net of current portion

2,677

3,655

Total non-current liabilities

570,166

563,088

Total liabilities

629,363

626,007

Shareholders’ equity

Total shareholders’ equity

149,343

198,901

Total liabilities and shareholders’ equity

778,706

824,908

uniQure N.V.

UNAUDITED CONSOLIDATED STATEMENTS OF OPERATIONS

Three months ended March 31,

2026

2025

(in thousands, U.S dollars, except share and per share amounts)

Total revenues

3,562

1,567

Operating expenses:

Cost of license revenues

(219)

(197)

Research and development expenses

(29,176)

(36,140)

Selling, general and administrative expenses

(20,068)

(10,908)

Total operating expenses

(49,463)

(47,245)

Other income

1,632

8,306

Other expense

(1,451)

(1,959)

Loss from operations

(45,720)

(39,331)

Non-operating items, net

(7,327)

(3,810)

Loss before income tax expense

(53,047)

(43,141)

Income tax expense

(488)

(496)

Net loss

(53,535)

(43,637)

Basic and diluted net loss per ordinary share

(0.85)

(0.82)

Weighted average shares used in computing basic and diluted net loss per ordinary share

62,742,847

53,110,580

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+ References

Reference 1: http://www.xbrl.org/2003/role/presentationRef

-Publisher SEC

-Name Exchange Act

-Number 240

-Section 14d

-Subsection 2b

+ Details

Name:

dei_PreCommencementTenderOffer

Namespace Prefix:

dei_

Data Type:

xbrli:booleanItemType

Balance Type:

Period Type:

duration

- Definition

Title of a 12(b) registered security.

+ References

Reference 1: http://www.xbrl.org/2003/role/presentationRef

-Publisher SEC

-Name Exchange Act

-Number 240

-Section 12

-Subsection b

+ Details

Name:

dei_Security12bTitle

Namespace Prefix:

dei_

Data Type:

dei:securityTitleItemType

Balance Type:

Period Type:

duration

- Definition

Name of the Exchange on which a security is registered.

+ References

Reference 1: http://www.xbrl.org/2003/role/presentationRef

-Publisher SEC

-Name Exchange Act

-Number 240

-Section 12

-Subsection d1-1

+ Details

Name:

dei_SecurityExchangeName

Namespace Prefix:

dei_

Data Type:

dei:edgarExchangeCodeItemType

Balance Type:

Period Type:

duration

- Definition

Boolean flag that is true when the Form 8-K filing is intended to satisfy the filing obligation of the registrant as soliciting material pursuant to Rule 14a-12 under the Exchange Act.

+ References

Reference 1: http://www.xbrl.org/2003/role/presentationRef

-Publisher SEC

-Name Exchange Act

-Number 240

-Section 14a

-Subsection 12

+ Details

Name:

dei_SolicitingMaterial

Namespace Prefix:

dei_

Data Type:

xbrli:booleanItemType

Balance Type:

Period Type:

duration

- Definition

Trading symbol of an instrument as listed on an exchange.

+ References

No definition available.

+ Details

Name:

dei_TradingSymbol

Namespace Prefix:

dei_

Data Type:

dei:tradingSymbolItemType

Balance Type:

Period Type:

duration

- Definition

Boolean flag that is true when the Form 8-K filing is intended to satisfy the filing obligation of the registrant as written communications pursuant to Rule 425 under the Securities Act.

+ References

Reference 1: http://www.xbrl.org/2003/role/presentationRef

-Publisher SEC

-Name Securities Act

-Number 230

-Section 425

+ Details

Name:

dei_WrittenCommunications

Namespace Prefix:

dei_

Data Type:

xbrli:booleanItemType

Balance Type:

Period Type:

duration