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 December 2022
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 ¨
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): ¨
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): ¨
Entry into a Material Definitive Agreement
Collaboration Agreement
On December 21, 2022,
ProQR Therapeutics N.V. (“ProQR”), acting through ProQR Therapeutics VIII B.V. (“ProQR VIII” and together
with ProQR, the “Company”), entered into an Amended and Restated Research and Collaboration Agreement (as amended and
restated, the “Collaboration Agreement”) with Eli Lilly and Company (“Lilly”). This agreement amended and
restated the Company’s existing collaboration agreement with Lilly that was entered into in September 2021, to allow the
parties to continue and expand their work on 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
continue to use the Company’s proprietary Axiomer® RNA editing platform to progress new drug targets toward clinical
development and commercialization. Through the expanded collaboration, the parties intend to explore further applications of the
Axiomer platform and progress additional drug targets, and Lilly grants the Company access to approved uses of
certain Lilly technology.
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 an increased number of targets, and Lilly can exercise an option to further
increase the total number of targets. The Company retains all rights not granted to Lilly.
Under the Collaboration Agreement, Lilly will grant the Company certain non-exclusive licenses, with the right to grant approved sublicenses
through multiple tiers during a specified time period, to certain Lilly technology to enable the Company to develop, manufacture and commercialize
products approved by Lilly using such Lilly technology. Lilly has rights during a specified time period to engage in exclusive negotiations
with the Company with respect to certain Company products. Under the Collaboration Agreement, Lilly is eligible to receive tiered royalties
of up to low-single digit percentage on product sales for products covering licensed Lilly technology 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.
Pursuant to the terms of the
Collaboration Agreement, Lilly will pay the Company a one-time,
non-refundable, non-creditable upfront payment of $50.0 million as consideration for the rights granted by the Company and $10.0 million for the options granted by the Company (in addition to the $20.0 million upfront fee paid under the original
collaboration), with Lilly also making an additional $15.0 million equity investment in the Company pursuant to a share purchase agreement
between the parties (the “Share Purchase Agreement”). Lilly will have the ability to exercise an option to further expand
the partnership for a consideration of $50.0 million. Under the Collaboration Agreement, the Company is also eligible to receive up to
approximately $3.75 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 or the Company has no royalty payment obligations with respect to such product,
and, with respect to certain sublicenses granted by the Company until the sublicense expires or terminates. 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 (except with respect to Company products). 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 December 21, 2022, pursuant to which the Company agreed to issue
and sell to Lilly 9,381,586 shares (the “Lilly Shares”) of the Company’s ordinary shares, nominal value €0.04
per share (“Ordinary Shares”), for an aggregate purchase price of $15,000,000.29. 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 December 21, 2022 until the earlier of (i) June 21, 2023 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. Lilly has also agreed to a standstill on acquiring additional shares of the Company and proposing certain
transactions to the Company or its shareholders, all on the terms, and subject to the exceptions, contained in the Share Purchase
Agreement.
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.
On December 22, 2022, the
parties issued a joint press release announcing the above transactions, a copy of which is attached hereto as Exhibit 99.1 and is incorporated
herein by reference.
On December 22, 2022, the
Company hosted a webcasted conference call to discuss its Axiomer® RNA editing platform following its recently announced expanded
collaboration with Eli Lilly and Company. A copy of the presentation is attached hereto as Exhibit 99.2 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 Nos. 333-248740; 333-260775;
333-260780; 333-263166).
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 December 21, 2022 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 other development activities by us and our collaborative partners whose
operations and activities may be slowed or halted by shortage and pressure on supply and logistics on the global market; our reliance on contract manufacturers or suppliers to supply materials
for research and development and the risk of supply interruption or delays from suppliers or contract manufacturers; 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: December 23, 2022 |
By: |
/s/ René Beukema |
| |
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René Beukema |
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|
Chief Corporate Development Officer and General Counsel |
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.
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