Uniqure SEC Filings

uniQure (QURE) filed its Q3 2025 10‑Q, reporting wider losses but a much stronger cash position. Total revenues were $3.7 million, up from $2.3 million a year ago, driven by license revenue. Net loss was $80.5 million, compared to $44.4 million, as R&D and SG&A expenses increased and royalty‑financing interest remained sizable.

Liquidity improved materially: cash and cash equivalents were $597.1 million as of September 30, 2025. The company completed follow‑on offerings in January/February and September, receiving net proceeds of $70.1 million, $10.4 million, and $323.7 million, respectively; September included pre‑funded warrants to purchase 0.5 million shares and a $30.7 million related liability at quarter‑end. Liability from the HEMGENIX royalty financing was $469.1 million.

Debt was refinanced under a Hercules facility maturing October 1, 2030, with $50.0 million drawn and up to $100.0 million more available upon a Biologics License Application (BLA) approval for AMT‑130 prior to June 15, 2027. The company reported positive AMT‑130 Phase I/II topline data; however, following an October pre‑BLA meeting, the FDA feedback indicates the external‑control data may not be adequate as primary evidence, making BLA timing unclear. Ordinary shares outstanding were 62,165,900 as of September 30, 2025.

uniQure N.V. (QURE) furnished a press release announcing financial results for the quarter ended September 30, 2025 and provided a corporate update. The release is included as Exhibit 99.1 to a Form 8-K dated November 10, 2025.

The company states the information furnished under Item 2.02, including Exhibit 99.1, is not deemed “filed” under the Exchange Act. uniQure’s ordinary shares trade on the Nasdaq Global Select Market under the symbol QURE.

uniQure N.V. (QURE) disclosed that a director executed option exercises and same‑day sales on 11/04/2025 pursuant to a Rule 10b5‑1 trading plan adopted on June 16, 2025.

The director exercised 10,000 options at $7.37, 11,000 at $5.37, and 17,810 at $14.08, then sold equivalent ordinary shares at weighted average prices of $30.36, $30.34, and $30.33, respectively. Following these transactions, the director beneficially owned 20,439 ordinary shares, held directly.

uniQure reported a regulatory setback for AMT-130, its investigational gene therapy for Huntington’s disease. Following a pre-BLA meeting, the company believes the FDA currently no longer agrees that data from its Phase I/II studies, analyzed against an external control per prespecified protocols and statistical plans, may be adequate as primary evidence for a BLA.

As a result, the timing of the BLA submission for AMT-130 is now unclear. The update was announced on November 3, 2025 via a press release furnished as an exhibit. The disclosure highlights risks common to early-stage gene therapies, including evolving regulatory views on endpoints and comparators, and the potential need for additional clinical evidence.

uniQure N.V. insider Matthew C. Kapusta completed option exercises and multiple open-market sales under a 10b5-1 plan on September 24, 2025. The filing shows exercises of stock options at $7.53 (51,316 shares) and $6.22 (175,000 shares), producing reported acquisitions of 226,316 ordinary shares that increased his beneficial holdings to 877,770 shares before subsequent sales. The reporting person sold a series of shares the same day in multiple transactions at weighted-average prices reported between $39.20 and $45.30, resulting in a net decline to 651,454 shares beneficially owned after all reported sales. The transactions were made pursuant to a January 28, 2025 Rule 10b5-1 plan, and the Form 4 was signed by an attorney-in-fact on September 26, 2025.

uniQure N.V. (QURE) is conducting a registered offering of 5,789,473 ordinary shares and, in lieu of shares to certain investors, 526,316 pre-funded warrants exercisable at $0.0001 per share. The prospectus supplement cites a Nasdaq last sale price of $52.65 on September 25, 2025. Estimated net proceeds are approximately $281.45 million (or $323.75 million if the underwriters' option is exercised) to fund commercialization readiness, a potential AMT-130 launch, development of other clinical candidates and general corporate purposes. Recent clinical updates include positive 36-month topline Phase I/II results for AMT-130: a statistically significant 75% slowing on cUHDRS (p=0.003) and 60% slowing on TFC (p=0.033) for the high-dose group, supportive biomarker change (CSF NfL -8.2%), and a planned pre-BLA meeting with the FDA ahead of an intended BLA submission in Q1 2026. Other programs: AMT-260 (GenTLE) reported a 92% seizure reduction in an early participant; AMT-191 showed sustained GLA activity in four patients; AMT-162 (SOD1-ALS) enrollment is voluntarily paused after a dose-limiting toxicity in one patient. Separately, Dutch tax authorities informed the company that a 2023 EUR 342 million royalty upfront should be treated as 2023 income for Dutch tax purposes; uniQure estimates a tax liability in the mid single- to low double-digit millions of dollars and will record a current tax liability in the quarter ended September 30, 2025.

Form 144 filed relating to proposed sale of uniQure N.V. (QURE) ordinary shares. The notice reports a proposed sale of 15,000 ordinary shares through Citigroup Global Markets on 09/26/2025 with an aggregate market value of $825,000.00 and total shares outstanding noted as 54,866,930. The shares were acquired and to be sold on 09/26/2025 via a stock option exercise and sale pursuant to a 10b5-1 plan, with payment in cash. The filer also reported a prior sale of 3,000 shares on 09/24/2025 generating $120,119.00 in gross proceeds.

Form 144 notice by uniQure N.V. (QURE) reporting a proposed sale of 3,000 ordinary shares through Citigroup Global Markets on 09/24/2025 with an aggregate market value of $120,000.00. The filing lists total shares outstanding as 54,866,930. The securities were acquired and are to be sold on 09/24/2025 as the result of a stock option exercise and sale pursuant to a Rule 10b5-1 plan, and payment for the acquisition was in cash. The filer indicates no securities sold by the same person in the past three months and includes the standard representation that the person does not possess undisclosed material adverse information.