0001104659-23-107209.txt : 20231005 0001104659-23-107209.hdr.sgml : 20231005 20231005163201 ACCESSION NUMBER: 0001104659-23-107209 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 14 CONFORMED PERIOD OF REPORT: 20231005 ITEM INFORMATION: Cost Associated with Exit or Disposal Activities ITEM INFORMATION: Departure of Directors or Certain Officers; Election of Directors; Appointment of Certain Officers: Compensatory Arrangements of Certain Officers ITEM INFORMATION: Other Events ITEM INFORMATION: Financial Statements and Exhibits FILED AS OF DATE: 20231005 DATE AS OF CHANGE: 20231005 FILER: COMPANY DATA: COMPANY CONFORMED NAME: uniQure N.V. CENTRAL INDEX KEY: 0001590560 STANDARD INDUSTRIAL CLASSIFICATION: PHARMACEUTICAL PREPARATIONS [2834] IRS NUMBER: 000000000 FISCAL YEAR END: 1231 FILING VALUES: FORM TYPE: 8-K SEC ACT: 1934 Act SEC FILE NUMBER: 001-36294 FILM NUMBER: 231311748 BUSINESS ADDRESS: STREET 1: PAASHEUVELWEG 25A CITY: AMSTERDAM STATE: P7 ZIP: 1105 BP BUSINESS PHONE: 1-339-970-7000 MAIL ADDRESS: STREET 1: PAASHEUVELWEG 25A CITY: AMSTERDAM STATE: P7 ZIP: 1105 BP FORMER COMPANY: FORMER CONFORMED NAME: uniQure B.V. DATE OF NAME CHANGE: 20131030 8-K 1 tm2327835d1_8k.htm FORM 8-K

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): October 5, 2023

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: +31-20-566-7394

(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 2.05

Costs Associated with Exit and Disposal Activities.

On October 5, 2023, uniQure N.V. (the “Company”) announced it is implementing a strategic reorganization plan (the “Plan”) intended to reduce operational expenses while supporting focused execution intended to rapidly advance multiple clinical-stage programs to proof-of-concept. The Plan includes the discontinuation of more than half of the Company’s research and technology projects, the elimination of approximately 28% of the Company’s global workforce and the closure of a research lab in Lexington, MA.

The Company estimates that it will incur charges of approximately $2.3 million in connection with the Plan, consisting primarily of cash expenditures related to employee severance costs. The Company anticipates the Plan will be substantially complete by the end of fiscal year 2023. These costs are subject to assumptions, including local law requirements, and actual expenses may differ materially from the estimates disclosed above.

Forward-Looking Statements

This Current Report on Form 8-K contains forward-looking statements within the meaning of Section 27A of the Securities Act and Section 21E of the Exchange Act. 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 and the negatives of those terms. Forward-looking statements are based on management’s beliefs and assumptions and on information available to management only as of the date of this Current Report on Form 8-K. These forward-looking statements include, but are not limited to, statements about the Company’s expectations regarding the costs, benefits, timing and financial impact of the Plan. The Company’s actual results could differ materially from those anticipated in these forward-looking statements for many reasons, including risks related to conducting the risks, uncertainties and other factors described under the heading “Risk Factors” in the Company’s periodic securities filings, including its Annual Report on Form 10-K filed with the Securities and Exchange Commission on February 27, 2023 and its Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission on August 1, 2023. 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.

Item 5.02

Departure of Directors or Certain Officers; Election of Directors; Appointment of Certain Officers; Compensatory Arrangements of Certain Officers.

On October 5, 2023, the Company announced that, effective October 4, 2023 (the “Effective Date”), Ricardo Dolmetsch terminated his employment with the Company as its Chief Scientific Officer for Good Reason, as such term is defined in the employment agreement, dated September 14, 2020, by and between Dr. Dolmetsch and uniQure, Inc., a subsidiary of the Company (the “Employment Agreement”). In connection therewith, Dr. Dolmetsch and uniQure, Inc. entered into a letter agreement on October 4, 2023 (the “Letter Agreement”), pursuant to which, subject to the execution of a general release, Dr. Dolmetsch is entitled to receive the severance benefits set forth in Sections 19(h)(i)(a), (ii), and (iii) of the Employment Agreement. Specifically, Dr. Dolmetsch is entitled to accrued benefits, and payment of COBRA premiums for a period of 12 months following the termination of his employment. Additionally, Dr. Dolmetsch will receive a lump-sum payment of approximately $1.025 million, which is equal to 12 months of base salary and target bonus, as well as a bonus pro-rated to the date of termination and based on the target bonus amount set by the Board, which is currently 50%.

In connection with his termination of employment and in furtherance of the Company’s succession plans, Dr. Dolmetsch and uniQure, Inc., entered into a consulting agreement (the “Consulting Agreement”). Pursuant to the Consulting Agreement, commencing on October 4, 2023, Dr. Dolmetsch will provide consulting services related to the transition of his duties and other consulting services that may be reasonably requested until December 31, 2023, unless terminated earlier in accordance with the terms of the Consulting Agreement (the “Term”). In consideration, Dr. Dolmetsch will receive a consulting fee equal to $10,000 per month during the Term and his equity awards will continue to vest in accordance with their terms through the Term.

In connection with Dr. Dolmetsch’s transition, the Board of Directors of the Company have designated Richard Porter, the Company’s current Chief Business Officer, to serve as the Company’s Chief Business and Scientific Officer, effective as of October 5, 2023.

The foregoing description of the material terms of the Letter Agreement and the Consulting Agreement does not purport to be complete and is qualified in its entirety by reference to the full text of the Letter Agreement and the Consulting Agreement, a copy of which will be filed with the Securities and Exchange Commission as an exhibit to the Company’s Quarterly Report on Form 10-Q for the quarter ended September 30, 2023.

Item 8.01

Other Events.

On October 5, 2023, the Company issued a press release announcing the foregoing. A copy of the press release is attached to this Current Report on Form 8-K as Exhibit 99.1 and incorporated herein by reference.

Item 9.01

Financial Statements and Exhibits.

(d) Exhibit

Exhibit No.		Description
99.1		Press Release of uniQure N.V., dated October 5, 2023
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, thereunto duly authorized.

	UNIQURE N.V.

Date: October 5, 2023	By:	/s/ Jeannette Potts
		Jeannette Potts
		Chief Legal and Compliance Officer

EX-99.1 2 tm2327835d1_ex99-1.htm EXHIBIT 99.1

Exhibit 99.1

uniQure Announces Strategic Reorganization to Reduce Operating Expenses and Support Advancement of Multiple Clinical-Stage Programs

~ Reduction of 28% of workforce not related to HEMGENIX^®manufacturing obligations; Total cost savings of $180 million to extend cash runway into second quarter of 2027 ~

~ Discontinuing investments in more than half of research and technology projects, centralizing operations, and streamlining organization ~

~ Prioritizing continued development of AMT-130 in Huntington’s disease and near-term initiation of clinical trials for AMT-260 in refractory mesial temporal lobe epilepsy, AMT-162 in SOD1-ALS, and AMT-191 in Fabry disease; Multiple potential value drivers expected over next two years ~

~ As a result of reprioritization, Ricardo Dolmetsch, Ph.D. Chief Scientific Officer to depart the Company and Rich Porter, Ph.D. Chief Business Officer will assume responsibilities for research as well as nonclinical and vector development ~

Lexington, MA and Amsterdam, the Netherlands, October 5, 2023 — uniQure N.V. (NASDAQ: QURE), a leading gene therapy company advancing transformative therapies for patients with severe medical needs, today announced a strategic reorganization that will significantly reduce operating expenses while supporting focused execution to rapidly advance multiple clinical-stage programs to proof-of-concept.

“At uniQure, our highest priority is to deliver innovative, life-changing therapies to patients with significant unmet needs. To accomplish our mission and generate near-term value for our stakeholders, we will implement a strategic restructuring of our business,” stated Matt Kapusta, chief executive officer of uniQure. “We are taking important actions today to cut operating expenses while ensuring that we have the necessary resources to advance our prioritized clinical-stage programs as rapidly as possible to proof-of-concept. Following an extensive review, we plan to discontinue more than half our research and technology projects and focus our R&D efforts on programs that leverage our CNS and liver-targeted gene therapy expertise, have the potential for expedited clinical proof of concept, and have attractive risk-value profiles. We remain fully committed to carefully managing costs, prudently allocating capital, rigorously assessing our clinical development priorities as new data emerges, and thoughtfully evaluating strategies that can enhance value for shareholders.”

“These were difficult but necessary decisions,” he added. “I’m truly grateful for the commitment and contributions of our many colleagues, and we remain fully committed to delivering on our promise to patients in need. We also look forward to sharing longer-term, interim data on our Huntington’s disease program in late fourth quarter of this year and initiating clinical trials for our other programs as rapidly as possible.”

Restructuring Operations and Reducing Expenses

Following an extensive review of the pipeline, the Company will discontinue more than half of its research and technology projects, including AMT-210 for the treatment of Parkinson’s disease and multiple undisclosed programs. The company will focus its research efforts on a limited number of projects believed to have optimal risk, value and speed attributes, including AMT-161 for c9orf72 amyotrophic lateral sclerosis (ALS), AMT-240 for autosomal dominant Alzheimer's disease, and next-generation AAV capsid development. As a result of the reprioritization, the Company will be closing a research lab in Lexington and plans to sublease this space.

The Company will also consolidate all GMP manufacturing into its Lexington, MA manufacturing facility and consolidate process and analytical development into its Amsterdam, Netherlands facility. Commercial manufacturing of HEMGENIX^® for CSL Behring will be unaffected by these actions.

As a result of the restructuring plan, the Company expects:

·

Elimination of 114 positions, which represents 28% of the workforce not committed to HEMGENIX manufacturing obligations, and approximately 20% of the total workforce

·

Total cost savings of approximately $180 million over the next three years

·

Current balance of cash, cash equivalents and investment securities of $628.6 million as of June 30, 2023 (excludes $100 million milestone payment subsequently received from CSL Behring) to fund operations into the second quarter of 2027

·

One-time restructuring costs of approximately $2.3 million, primarily incurred in the fourth quarter of 2023

Prioritizing Clinical-stage Programs

The Company plans to focus resources on driving execution across four clinical-stage programs and expediting near-term proof-of-concept data readouts.

·

AMT-130 for the treatment of Huntington’s disease: In the fourth quarter of 2023, the Company plans to provide a clinical update from both the U.S. Phase I/II study of AMT-130, including 18- and 30-month follow-up data from the treated patients in the high- and low-dose U.S. cohorts, respectively, and for the first time, the European Phase I/II study. In the first quarter of 2024, the Company expects to meet with the FDA to review the data and discuss future development of AMT-130. Also in 2024, the Company will present up to 3-year follow-up data on all patients in the U.S. and European Phase I/II trials, including at least 2-year follow-up data on more than half of patients treated with AMT-130.

·

AMT-260 for the treatment of refractory mesial temporal lobe epilepsy: In the third quarter of 2023, the Company announced the clearance of an investigational new drug (IND) for the Phase I/IIa clinical study of AMT-260. Screening and patient enrollment is expected to begin in the fourth quarter of 2023 with first patient dosing occurring in the first quarter of 2024.

·

AMT-162 for the treatment of SOD1-ALS: The Company expects to initiate patient screening in the fourth quarter of 2023 with first patient dosing occurring in the first quarter of 2024.

·

AMT-191 for the treatment of Fabry disease: The Company continues to expect to submit an IND in the fourth quarter of 2023 and to begin patient dosing in 2024.

Aligning Leadership Team

Changes on the Company’s leadership team are aligned with this strategic reorganization and pipeline prioritization. Walid Abi-Saab, M.D., who joined the Company as Chief Medical Officer in June 2023, will continue to lead development of all clinical-stage programs. Due to the significant reduction in research activities, Ricardo Dolmetsch, Ph.D., the Company’s current chief scientific officer, is departing the Company and will remain as a scientific consultant through the end of the year. Richard Porter, Ph.D., will assume responsibilities for research, as well as non-clinical and vector development in his new role as Chief Business and Scientific Officer. He will continue to oversee business development and product planning.

Dr. Porter has more than 25 years of neuroscience leadership in the biopharma industry and joined uniQure in June 2021 through the acquisition of Corlieve Therapeutics, where he was founder and chief executive officer.

“I want to express my sincere gratitude to Ricardo for his leadership in advancing our research and development programs over the last several years and for bringing innovative ideas and energy to the Company,” added Matt Kapusta. “I look forward to working with Rich in his expanded role as he advances our research and technology efforts and continues to lead our business development activities.”

About uniQure

uniQure’s mission is to reimagine the future of medicine by delivering innovative cures that transform lives. The recent approvals of our gene therapy for hemophilia B – a historic achievement based on more than a decade of research and clinical development – represents a major milestone in the field of genomic medicine and ushers in a new treatment approach for patients living with hemophilia. We are now leveraging our modular and validated technology and manufacturing platform to advance a pipeline of proprietary gene therapies for the treatment of patients with Huntington's disease, refractory mesial temporal lobe epilepsy, amyotrophic lateral sclerosis (ALS), 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. These forward-looking statements include, but are not limited to, statements that the Company’s restructuring will have anticipated cost savings of approximately $180 million through 2027 and will extend the Company’s cash runway to the second quarter of 2027, statements regarding the timing, expectations and sufficiency of our clinical trials, patient enrollment of our current and planned clinical trials and the timing thereof. The Company’s actual results could differ materially from those anticipated in these forward-looking statements for many reasons, including, without limitation, risks associated with the regulatory approval and commercial launch of HEMGENIX^®, material changes to our interim or preliminary data, our clinical trial for Huntington’s disease, the impact of financial and geopolitical events on our Company and the wider economy and health care system, our Commercialization and License Agreement with CSL Behring, our clinical development activities, clinical results, collaboration arrangements, regulatory oversight, product commercialization and intellectual property claims and ongoing litigation, as well as the risks, uncertainties and other factors described under the heading "Risk Factors" in the Company’s periodic securities filings, including its Annual Report on Form 10-K filed February 27, 2023 and the Quarterly Report on Form 10-Q filed August 1, 2023. 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:

Maria E. Cantor	Chiara Russo	Tom Malone
Direct: 339-970-7536	Direct: 617-306-9137	Direct: 339-970-7558
Mobile: 617-680-9452	Mobile: 617-306-9137	Mobile:339-223-8541
m.cantor@uniQure.com	c.russo@uniQure.com	t.malone@uniQure.com

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Cover	Oct. 05, 2023
Cover [Abstract]
Document Type	8-K
Amendment Flag	false
Document Period End Date	Oct. 05, 2023
Entity File Number	001-36294
Entity Registrant Name	uniQure N.V.
Entity Central Index Key	0001590560
Entity Tax Identification Number	00-0000000
Entity Incorporation, State or Country Code	P7
Entity Address, Address Line One	Paasheuvelweg 25a
Entity Address, City or Town	Amsterdam
Entity Address, Country	NL
Entity Address, Postal Zip Code	1105 BP
City Area Code	+31
Local Phone Number	20-566-7394
Written Communications	false
Soliciting Material	false
Pre-commencement Tender Offer	false
Pre-commencement Issuer Tender Offer	false
Title of 12(b) Security	Ordinary Shares, par value €0.05 per share
Trading Symbol	QURE
Security Exchange Name	NASDAQ
Entity Emerging Growth Company	false

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