Amended and Restated Biologics Master Services Agreement – WuXi Biologics (Hong Kong) Limited
In April 2023, Paragon and WuXi Biologics (Hong Kong) Limited (“WuXi Biologics”) entered into a biologics master services agreement (the “Original MSA”), which was subsequently novated to the Company by Paragon on September 19, 2023 pursuant to a novation agreement (the “Novation Agreement”) among the Company, Paragon and WuXi Biologics.
On October 14, 2024, the Original MSA was amended and restated by WuXi Biologics and the Company (the “A&R MSA”). Among other things, the A&R MSA added a termination provision that allows the A&R MSA to be terminated, in whole or in part, by the Company in the event that any law is enacted that has, or could be reasonably expected to have, a material adverse effect on the Company or any product of the Company that is the subject of the A&R MSA, in each case, as a result of WuXi Biologics providing services under the A&R MSA or the Company being a party to the A&R MSA. The A&R MSA also incorporated certain technology transfer, discount and priority in access obligations for WuXi Biologics.
Amended and Restated Cell Line License Agreement – WuXi Biologics (Hong Kong) Limited
In April 2023, Paragon and WuXi Biologics entered into a cell line license agreement (the “Original CLLA”), which was subsequently novated to the Company by Paragon pursuant to the Novation Agreement.
On October 14, 2024, the Original CLLA was amended and restated by WuXi Biologics and the Company (the “A&R CLLA”). Among other things, the A&R CLLA added terms that permit the royalties owed under the A&R CLLA to be bought out on a product-by-product basis for a lump-sum payment and certain financial terms to address risks related to potential changes in or new applicable laws.
The foregoing are brief descriptions of the terms and conditions of the SPY003 License Agreement and amendments to the Original MSA and Original CLLA that are detailed in the A&R MSA and the A&R CLLA, respectively, that are material to Company and do not purport to be complete. Each description is each qualified in its entirety by reference to the complete text of the SPY003 License Agreement, the A&R MSA and the A&R CLLA, respectively, copies of which are attached hereto, with confidential terms redacted, as Exhibits 10.1, 10.2 and 10.3, respectively.
| Item 7.01 | Regulation FD Disclosure |
On October 14, 2024, the Company issued a press release announcing the expected acceleration of its SPY003 product candidate clinical timelines and presentations of preclinical data for each of its product candidates and combinations of SPY003 with either SPY001 or SPY002.
The information in this Item 7.01 of this Current Report on Form 8-K, including Exhibit 99.1 attached hereto, is intended to be furnished and shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”) or otherwise subject to the liabilities of that section, nor shall it be deemed incorporated by reference in any filing under the Securities Act of 1933, as amended, or the Exchange Act, except as expressly set forth by specific reference in such filing.
On October 14, 2024, the Company posted an updated corporate presentation (the “Corporate Presentation”) on its website. The Corporate Presentation includes, without limitation, updates for its anti-α4b7 antibody research program, SPY001, its anti-TL1A antibody research program, SPY002, its anti-IL-23 antibody research program, SPY003, and therapeutic combinations of the foregoing. A copy of the Corporate Presentation is attached hereto as Exhibit 99.2 to this Current Report on Form 8-K and is incorporated herein by reference.
