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There have been no material changes from the risk factors disclosed in our Form 10-K for the year ended December 31, 2025, except for the following:
We Are Subject to Significant Litigation Risk and Cannot Predict the Outcome of Our Pending Lawsuit Against Our Licensor
We have initiated litigation against NMS alleging wrongful purported termination of the Agreement and other claims. NMS has responded with counterclaims. The outcome of litigation is inherently uncertain. There can be no assurance that we will prevail on any or all of our claims, that we will obtain the relief we are seeking, or that a court will agree with our legal interpretation of the Agreement or our characterization of NMS's conduct. If the court determines that NMS's termination was valid, we would lose the rights granted under the Agreement, which could have a material adverse effect on our business, financial condition, results of operations, and prospects.
The Loss of Rights Under the Agreement Could Materially Disrupt Our Business Operations
The Agreement granted us an exclusive license to conduct research and to develop, make, use, offer for sale, sell, and import products or otherwise exploit NMS’s intellectual property rights that are integral to our development of onvansertib. If the termination of the Agreement is ultimately upheld, or if we are unable to obtain preliminary injunctive relief requiring continuation of our licensed rights during the pendency of this litigation through specific performance, we may be required to:
•cease or significantly curtail certain business operations or product offerings;
•seek alternative technology, intellectual property, or proprietary assets, which may not be available on commercially reasonable terms or at all; and/or
•write down or impair the value of assets associated with our use of the licensed rights.
Any of the foregoing consequences could materially and adversely affect our business, financial condition, results of operations and prospects.
We May Not Be Able to Obtain or Maintain Permanent or Preliminary Injunctive Relief
We have sought preliminary injunctive relief to preserve our rights under the Agreement during the course of litigation. There is no guarantee that a court will grant such relief. Courts apply exacting standards to the issuance of preliminary injunctions, including requirements that the moving party demonstrate, among other things, a likelihood of success on the merits, irreparable harm, that the balance of equities favors relief, and that an injunction is in the public interest. Our inability to obtain such relief could result in NMS enforcing or attempting to enforce some or all of the termination provisions of the Agreement pending final adjudication, which could disrupt our ability to operate our business in the ordinary course and cause irreparable harm to our business and financial performance.
This Litigation Is Costly, Time-Consuming, and Could Divert Management Attention and Resources
Commercial litigation of this nature is expensive and time-consuming. We expect to incur significant legal fees and other litigation costs in connection with this dispute. These costs could be substantial and may continue for an extended period, as complex commercial litigation frequently takes multiple years to resolve at the trial court level, with potential additional time for appellate proceedings. In addition, the attention and resources of our senior management team may be diverted from day-to-day business operations in connection with discovery, depositions, court proceedings, and settlement negotiations. This diversion of resources could negatively affect our ability to execute on our strategic priorities and could adversely affect our business and results of operations.
We May Need to Established Financial Reserves That May Prove Inadequate
In accordance with applicable accounting standards, we may be required to establish reserves for this litigation to the extent a loss is probable and can be reasonably estimated. However, the actual costs and liabilities associated with this litigation may exceed any reserves we have established, and there can be no assurance that our reserves are adequate. Changes in our assessment of the likely outcome, or developments during the course of the litigation, may require us to increase our reserves, which could have a material adverse effect on our reported financial results in the period in which such reserves are increased.
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The Litigation May Affect Our Ability to Raise Capital or Enter Into Strategic Transactions
The pendency of this litigation could adversely affect our ability to raise additional equity or debt financing on favorable terms, or at all. Investors and lenders may perceive the litigation as a material contingent liability and may demand higher risk premiums, require additional covenants, or decline to participate in financing transactions until the matter is resolved. Similarly, the litigation may complicate or delay our ability to engage in mergers, acquisitions, or other strategic transactions, as potential counterparties may be unwilling to proceed in the face of unresolved material litigation. These constraints could limit our strategic and financial flexibility.
We May Be Unable to Obtain Replacement License Rights on Acceptable Terms
If the alleged termination of the Agreement is ultimately upheld, we may attempt to license the same or similar rights from NMS or from alternative sources. There is no guarantee that we will be able to negotiate a new license with NMS, or that such a license would be available on commercially acceptable terms. Alternative sources of equivalent intellectual property or technology may not exist, may be protected by third-party rights, may be subject to other encumbrances, or may not be available to us on terms that allow us to operate our business profitably. The failure to obtain replacement rights could have a material adverse effect on our business.
Litigation Outcomes Are Inherently Unpredictable and Subject to Appeal
Even if we prevail at the trial court level, NMS may appeal such a ruling, which could result in a reversal or modification of a favorable judgment, require additional litigation costs, and extend the period of uncertainty. Conversely, if an initial ruling is adverse to us, we may elect to appeal, which would similarly extend the litigation timeline and associated costs and uncertainty. The appellate process can take years and may not result in a final resolution that is more favorable to us than the initial ruling.