Item 1. Legal Proceedings
Item 1. Legal Proceedings.
From time to time, we may be involved in various legal proceedings and subject to claims that arise in the ordinary course of business, including those related to governmental inquiries, intellectual property and commercial relationships, including the arbitration disclosed in our Quarterly Report on Form 10-Q for the period ended June 30, 2025 filed with the SEC on August 11, 2025, and the legal proceeding disclosed in a Current Report on Form 8-K filed with the SEC on October 22, 2025. There have been no material updates with respect to such matters. The subject matter of any such legal proceedings or claims are or will be highly complex and subject to substantial uncertainties. The outcome of any such proceedings or claims, regardless of the merits, are and will be inherently uncertain; therefore, assessing the likelihood of loss and any estimated damages is difficult and subject to considerable judgment.
Item 1A. Ris k Factors.
Our business is subject to various risks, including those described in Item 1A of our Annual Report on Form 10-K for the fiscal year ended December 31, 2024, which we strongly encourage you to review. Except as disclosed below, there have been no material changes from the risk factors described in our Annual Report on Form 10-K for the year ended December 31, 2024 filed with the Commission on March 6, 2025.
A prolonged U.S. federal government shutdown could materially and adversely affect our business, operations, and legal proceedings.
On October 1, 2025, the federal government of the United States began a shutdown at 12:01 a.m. EDT as a result of congressional failure to pass appropriations legislation for the 2026 fiscal year, which began that day. A continued and prolonged shutdown could materially and adversely affect our business, operations, financial condition, and legal matters. A federal government shutdown may result in the furlough of federal employees, reduced availability of government services, and suspension or delay of activities by key agencies that regulate, fund, or interact with our business, including the SEC, the FDA, the HHS, and the U.S. Patent and Trademark Office. During such periods, review and approval of our filings, applications, and submissions could be delayed, and we may be unable to access or rely upon certain government data or systems. In addition, the Administrative Office of the U.S. Courts and federal judiciary operations rely on appropriated funds and fee-based reserves that may be exhausted in the event of an extended shutdown. If federal court funding lapses or is limited to “essential” functions only, civil litigation, bankruptcy proceedings, and regulatory enforcement actions involving us or our affiliates could be postponed or suspended. Any such delay could impede our ability to resolve disputes, enforce contractual rights, or obtain timely judicial relief, which may have a material adverse effect on our financial position or prospects. Such conditions could negatively impact our access to financing, timing of capital-raising transactions, and the liquidity or trading volume of our securities. Accordingly, the current federal government shutdown, or uncertainty regarding the continuity of government operations could have a material adverse effect on our business, results of operations, and stock price.
We have filed a lawsuit alleging trade secret misappropriation and breach of contract, and any unfavorable outcome or related proceedings could materially and adversely affect our business, financial condition, results of operations, and reputation.
On September 23, 2025, we filed a lawsuit in the United States District Court for the Southern District of California against AbbVie Inc., Capstan Therapeutics, Inc., and other defendants asserting claims for trade secret misappropriation and breach of contract. The defendants’ current deadline to respond to our complaint is December 1, 2025, and the court has not set a case schedule. Litigation is inherently uncertain, time-consuming, and costly. We may not prevail on our claims, and the defendants may assert counterclaims against us, including challenges to our intellectual property or allegations of our own misconduct, any of which could result in adverse rulings, monetary judgments, fee or cost awards, or other relief that may be material. Even if we are successful in whole or in part, the litigation could result in substantial expense, divert management’s attention and operational resources, disrupt relationships with partners, collaborators, or customers, and require the disclosure of sensitive information in discovery that could diminish the value of our trade secrets or other confidential information. The court could deny our requested relief, limit the scope of our asserted rights, or otherwise issue rulings that adversely affect our ability to protect, use, or commercialize our intellectual property and technology. In addition, associated proceedings, including motions practice, discovery disputes, and potential appeals, could be protracted and unpredictable, particularly given that the court has not yet established a case schedule. Any of these outcomes could negatively impact our competitive position, delay or impede our research, development, manufacturing, or commercialization activities, and result in increased legal and compliance costs. As a result, this litigation and any related proceedings could materially and adversely affect our business, financial condition, cash flows, and results of operations.
CSL Limited’s potential separation of CSL Seqirus could disrupt our collaboration and materially harm our business.
Reports that CSL Limited intends to separate or spin off its vaccine business, including its subsidiary CSL Seqirus, could disrupt or adversely affect our collaboration and materially harm our business. We are party to a strategic collaboration with CSL Seqirus for the development and commercialization of mRNA vaccines for COVID-19, influenza and certain other infectious diseases. We cannot
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predict the timing, terms, structure, or ultimate consummation of any potential separation, and even the announcement or pendency of such a transaction may create uncertainty and execution risk that could adversely affect CSL Seqirus’s performance under our agreements and, as a result, our programs, timelines and costs. For example, a separation could lead to shifting strategic priorities, changes in management focus, or reduced access to corporate resources, capital, manufacturing networks or commercial infrastructure previously available to CSL Seqirus as part of the CSL group. In addition, any stand‑alone entity may have a different risk profile, capital structure, credit quality, or appetite for development and commercial investment, which could impair its ability or willingness to satisfy funding, diligence, supply, or commercialization obligations or to continue programs that were prioritized prior to the separation.
Item 2. Unregistered Sales of Equi ty Securities and Use of Proceeds.
None.
Item 3. Defaults Upo n Senior Securities.
None.
Item 4. Mine Safe ty Disclosures.
Not applicable.
Text extracted from the filing as submitted to EDGAR. Formatting, tables and exhibits are simplified for reading; the original document is authoritative for anything you rely on.