UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 6-K
Report of Foreign Private Issuer
Pursuant to Rule 13a-16 or 15d-16 of
the Securities Exchange Act of 1934
For the month of September 2021
Commission File Number: 001-36622
PROQR THERAPEUTICS N.V.
Zernikedreef 9
2333 CK Leiden
The Netherlands
Tel: +31 88 166 7000
(Address, Including Zip Code, and Telephone
Number,
Including Area Code, of Registrant’s Principal Executive Offices)
Indicate by check mark whether the registrant files or will file annual
reports under cover of Form 20-F or Form 40-F.
Form 20-F
x Form 40-F o
Indicate
by check mark if the registrant is submitting the Form 6-K in paper as permitted by Regulation S-T Rule 101(b)(1): o
Indicate
by check mark if the registrant is submitting the Form 6-K in paper as permitted by Regulation S-T Rule 101(b)(7): o
Entry into a Material Definitive Agreement
Collaboration Agreement
On September 3, 2021,
ProQR Therapeutics N.V. (“ProQR”) entered into a Research and Collaboration Agreement (the “Collaboration Agreement”)
with ProQR Therapeutics VIII B.V. (“ProQR VIII” and together with ProQR, the “Company”) and Eli Lilly and Company
(“Lilly”). The Collaboration Agreement is for the discovery, development, and commercialization of potential new medicines
for genetic disorders in the liver and nervous system. Under the terms of the Collaboration Agreement, the Company and Lilly will seek
to use the Company’s proprietary Axiomer® RNA editing platform to progress new drug targets toward clinical development and
commercialization.
Under the Collaboration Agreement,
the Company will grant Lilly certain exclusive and non-exclusive licenses, with the right to grant sublicenses through multiple tiers
during a specified time period, to support the parties’ activities and to enable Lilly to develop, manufacture and commercialize
products derived from or containing compounds developed pursuant to such agreement. The Collaboration Agreement contemplates collaboration
on up to five (5) targets. The Company retains all rights not granted to Lilly.
Pursuant to the terms of the
Collaboration Agreement, as partial consideration for the rights granted by the Company, Lilly will pay the Company a one-time, non-refundable,
non-creditable upfront payment of $20.0 million, with Lilly also making a $30.0 million equity investment in the Company pursuant
to a share purchase agreement between the parties (the “Share Purchase Agreement”). Under the Collaboration Agreement, the
Company is also eligible to receive up to approximately $1.25 billion for development, regulatory and commercialization milestones, as
well as tiered royalties of up to mid-single digit percentage on product sales on a country-by-country and product-by-product basis until
the latest to occur of: (i) the expiration or abandonment of the last-to-expire valid claim in such country covering such product,
(ii) the expiration of all data or regulatory exclusivity periods for such product in such country, or (iii) a specified anniversary
of the first commercial sale of such product in such country, subject to certain royalty step-down provisions set forth in the Collaboration
Agreement.
The Collaboration Agreement
includes a specified research term for the parties to perform research and development activities, subject to a one-time option, exercisable
by Lilly at its sole discretion, to extend the term. Unless terminated earlier, the Collaboration Agreement will continue on a product-by-product
basis until Lilly has no royalty payment obligations with respect to such product or, if earlier, the termination of the Collaboration
Agreement or any program in accordance with the terms of the Collaboration Agreement, subject to certain standard reductions and offsets.
The Collaboration Agreement may be terminated in its entirety or on a program-by-program basis at any time without cause by Lilly following
a specified notice period. The Collaboration Agreement may also be terminated by either party under certain other circumstances, including
an uncured material breach of the other party or if a party challenges or opposes any patent owned by the other party and covered by the
Collaboration Agreement. If the Collaboration Agreement is terminated with respect to one or more programs, depending on the stage of
development, certain rights in the terminated programs revert to the Company, in accordance with the terms of the Collaboration Agreement.
The Collaboration Agreement includes various representations, warranties, covenants, indemnities and other customary provisions.
Share Purchase Agreement
In connection with the Collaboration
Agreement, ProQR and Lilly entered into the Share Purchase Agreement on September 3, 2021, pursuant to which the Company agreed to
issue and sell to Lilly 3,989,976 shares (the “Lilly Shares”) of the Company’s ordinary shares, nominal value €0.04
per share (“Ordinary Shares”), for an aggregate purchase price of $30.0 million. The issuance of the Lilly Shares occurred
concurrently with the entry by the parties into the Collaboration Agreement. The Share Purchase Agreement contains customary representations,
warranties, and covenants of each party.
Pursuant to the terms of the
Share Purchase Agreement, Lilly may not, subject to certain limited exceptions, dispose of any of the Lilly Shares for a period commencing
on September 3, 2021 until the earlier of (i) March 3, 2022 and (ii) the date that the Collaboration Agreement is
terminated. Additionally, under the Share Purchase Agreement, Lilly may participate in some public offerings and private placements of
the Company, subject to share ownership requirements and other limitations set forth in the Share Purchase Agreement. The Company has
also granted Lilly certain customary registration rights with respect to the Lilly Shares, including registering such shares for resale
on or prior to the expiration of the lockup agreement described above.
The foregoing summaries of
the Collaboration Agreement and the Share Purchase Agreement do not purport to be complete and are qualified in their entirety by reference
to the respective agreements, copies of which are attached hereto as exhibits to this Report of Foreign Private Issuer on Form 6-K
and are incorporated herein by reference. The Company intends to seek confidential treatment from the Securities and Exchange Commission
for certain portions of the Collaboration Agreement.
In addition, a copy of the
press release announcing the above transactions is attached hereto as Exhibit 99.1 and is incorporated herein by reference.
The Company hereby incorporates by reference the
information contained herein into the Company’s registration statements on Form F-3 (File No. 333-228251 and File No. 333-248740).
Unregistered Sale of Equity Securities.
As described in the section
titled “Share Purchase Agreement” in this Report of Foreign Private Issuer on Form 6-K, which is incorporated
in this section by reference, the Company agreed to sell the Lilly Shares to Lilly on September 3, 2021 pursuant to the Share Purchase
Agreement and subject to the satisfaction of the closing conditions contained therein. The Lilly Shares were offered and issued in a private
placement exempt from registration pursuant to Section 4(a)(2) of the Securities Act of 1933, as amended (the “Securities
Act”), or Regulation D promulgated thereunder, as a transaction by an issuer not involving a public offering. Lilly has represented
that it acquired the Lilly Shares for investment only and not with the intent to sell in connection with any distribution thereof, and
an appropriate legend was applied to the Lilly Shares.
Cautionary Note on Forward-Looking Statements
This Report of Foreign Private
Issuer on Form 6-K includes 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,” “estimate,”
“expect,” “goal,” “intend,” “look forward to”, “may,” “plan,”
“potential,” “predict,” “project,” “should,” “will,” “would” and
similar expressions. Such forward-looking statements include, but are not limited to, statements regarding the collaboration with Lilly
and the intended benefits thereof, including the upfront payment, equity investment, and milestone and royalty payments from commercial
product sales, if any, from the products covered by the collaboration, as well as the potential of our technologies and product candidates.
Forward-looking statements are based on management’s beliefs and assumptions and on information available to management only as
of the date of this report. Our actual results could differ materially from those anticipated in these forward-looking statements for
many reasons, including, without limitation, the risks, uncertainties and other factors in our filings made with the Securities and Exchange
Commission, including certain sections of our annual report filed on Form 20-F. These risks and uncertainties include, among others,
the cost, timing and results of preclinical studies and clinical trials and other development activities by us and our collaborative partners
whose operations and activities may be slowed or halted by the COVID-19 pandemic; the likelihood of our clinical programs being executed
on timelines provided and reliance on our contract research organizations and predictability of timely enrollment of subjects and patients
to advance our clinical trials and maintain their own operations; our reliance on contract manufacturers to supply materials for research
and development and the risk of supply interruption from a contract manufacturer; the potential for future data to alter initial and preliminary
results of early-stage clinical trials; the unpredictability of the duration and results of the regulatory review of applications or clearances
that are necessary to initiate and continue to advance and progress our clinical programs; the ability to secure, maintain and realize
the intended benefits of collaborations with partners, including the collaboration with Lilly; the possible impairment of, inability to
obtain, and costs to obtain intellectual property rights; possible safety or efficacy concerns that could emerge as new data are generated
in research and development; and general business, operational, financial and accounting risks, and risks related to litigation and disputes
with third parties. Given these risks, uncertainties and other factors, you should not place undue reliance on these forward-looking statements,
and we assume no obligation to update these forward-looking statements, even if new information becomes available in the future, except
as required by law.
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.
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PROQR THERAPEUTICS N.V.
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Date: September 8, 2021
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By:
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/s/ Smital Shah
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Smital Shah
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Chief Financial Officer
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INDEX TO EXHIBITS
* Portions of this exhibit have been redacted pursuant to a request
for confidential treatment in accordance with the rules of the Securities and Exchange Commission.
ProQR Therapeutics NV (NASDAQ:PRQR)
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ProQR Therapeutics NV (NASDAQ:PRQR)
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