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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.
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
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 |
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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