Kite and Arcellx Announce Strategic Collaboration to Co-develop and Co-commercialize Late-stage Clinical CART-ddBCMA in Multiple Myeloma
Summary
To deliver cell therapy globally, and at scale, it requires a highly coordinated, vertically integrated organization from R&D to commercialization to manufacturing, dedicated to the unique needs of this very complex field. Follow Kite on social media on Twitter (@KitePharma) and LinkedIn.Gilead Sciences, Inc. is a biopharmaceutical company that has pursued and achieved breakthroughs in medicine for more than three decades, with the goal of creating a healthier world for all people. Gilead Sciences acquired Kite in 2017.This press release includes forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 that are subject to risks, uncertainties and other factors, including the ability of the parties to complete the transaction in a timely manner or at all; the possibility that various closing conditions for the transaction may not be satisfied or waived, including the possibility that a governmental entity may prohibit, delay or refuse to grant approval for the consummation of the transaction; difficulties or unanticipated expenses in connection with the collaboration, including with respect to the co-development, co-commercialization, and manufacturing of CART-ddBCMA or other programs subject of the collaboration and associated funding; the risk that Gilead and Kite may not realize the anticipated benefits of the collaboration with Arcellx; the possibility that the parties may make a strategic decision to terminate this collaboration at any time; the risk that Gileads investment in Arcellx will lose value for any number of reasons; uncertainties relating to regulatory applications and related filing and approval timelines for CART-ddBCMA or other programs subject of the collaboration, including the risk that FDA may not approve any such programs on the currently anticipated timelines or at all, and any marketing approvals, if granted, may have significant limitations on its use; the potential effect of any of the foregoing on Gilead and Kites earnings; and any assumptions underlying any of the foregoing. All statements in this press release that are not purely historical are forward-looking statements, including the potential benefits, synergies and results that may be achieved through the proposed collaboration; the anticipated completion of the proposed transaction including the closing of a proposed concurrent equity investment; the anticipated payments expected to be received by Arcellx in connection with the collaboration, including potential milestones and royalties; expectations regarding the timing and outcomes of clinical trials for its product candidates; the expected capabilities, including in manufacturing and commercialization, of Kite and Arcellx to complete clinical development, obtain regulatory approval, and if approved, commercialize the product candidates; the collaborations impact on Arcellxs research and development, clinical and commercial activities, expenditures, capabilities and financials; Kites rights around certain ARC-SparX programs; and Arcellxs research and development pipeline plans in autologous and allogeneic programs and beyond myeloma. These forward-looking statements are neither promises nor guarantees and are subject to a variety of risks and uncertainties, including the ability to complete the proposed transaction, including the concurrent equity investment, in a timely manner or at all, including the possibility that a governmental entity may prohibit, delay or refuse to grant approval for the consummation of the transaction; the possibility that certain closing conditions to the proposed transaction will not be satisfied; uncertainty as to whether the anticipated benefits and opportunities of the proposed collaboration may not be realized or make take longer to realize or may cost more than expected; challenges in technology transfer and cell therapy manufacturing, particularly in scaling up to commercial supply volumes, that can limit the benefits of the collaboration; challenges inherent in new product candidate development, including the uncertainty of clinical success and obtaining regulatory approvals; challenges associated with collaborating with third parties, including intellectual property, operational, financial and other risks; uncertainty of commercial success for new products; the ability of Arcellx and Kite to successfully execute their strategic plans; the risk that the collaboration can be terminated; potential for other unexpected hurdles, costs or delays; and other risks that may be found in the section entitled Part II, Item 1A (Risk Factors) in the Quarterly Report on Form 10-Q for the period ended September 30, 2022, filed with the Securities and Exchange Commission (SEC) on November 14, 2022, and other documents that Arcellx files from time to time with the SEC.