Our business, financial condition, and operating results may be affected by a number of factors, whether currently known or unknown, including, but not limited to, those described in Part I, Item 1A, “Risk Factors” of our Annual Report on Form 10-K for the year ended December 31, 2025. Any one or more of such factors could directly or indirectly cause our actual results of operations and financial condition to vary materially from past or anticipated future results of operations and financial condition. Any of these factors, in whole or in part, alone or combined with any of the other factors, could materially and adversely affect our business, financial condition, results of operations, and stock price. Except as set forth below, there have been no material changes to our risk factors since our Annual Report on Form 10-K for the year ended December 31, 2025. The following risk factors are new as a result of entering into the Loan Agreement in June 2026: Risks Related to our Indebtedness Servicing the Loan Agreement will require a significant amount of cash, and we may not have sufficient cash flow to pay our indebtedness. Our ability to make scheduled payments of the principal of, to pay interest on, or to refinance our indebtedness associated with the Loan Agreement depends on our future performance, which is subject to many factors, including economic, financial, competitive, and others, that are beyond our control. We do not expect our business to be able to generate cash flow from operations and expect to continue to incur significant losses in the foreseeable future until and if we begin generating substantial product revenue from product sales that would be sufficient to service our debt and make necessary capital expenditures. Without sufficient resources, we may therefore be required to adopt one or more alternatives, such as selling assets, restructuring debt, or obtaining additional equity capital on terms that may be onerous or highly dilutive. Our ability to refinance the Loan Agreement, which matures in 2031, will depend on the capital markets and our financial condition at such time. We may not be able to engage in any of these activities or engage in these activities on desirable terms, which could result in a default on our debt obligations and limit our flexibility in planning for and reacting to changes in our business. Our indebtedness and liabilities could have significant negative consequences for our security holders and our business, results of operations, and financial condition by, among other things: •increasing our vulnerability to adverse economic and industry conditions; •limiting our ability to obtain additional financing on acceptable terms or at all; •requiring the dedication of a substantial portion of any cash flow from operations to service our indebtedness, which would reduce the amount of cash available for other purposes; •limiting our flexibility to plan for, or react to, changes in our business; •diluting the interests of our existing stockholders as a result of issuing shares of our common stock; and 33 Table of Contents •placing us at a possible competitive disadvantage with competitors that are less leveraged than us or have better access to capital. Any of these factors could harm our business, prospects, operating results, and financial condition. In addition, if we incur additional indebtedness, the risks related to our business and our ability to service or repay our indebtedness and secured obligations will increase. We have entered into the Loan Agreement, pursuant to which we have granted the lenders a security interest in substantially all of our assets, including our intellectual property. If we default on our obligations under the Loan Agreement, the lenders could foreclose on our assets, which could materially adversely affect our business, financial condition, results of operations, and prospects. The Loan Agreement contains customary affirmative and negative covenants, representations, and warranties, including certain restrictive covenants setting forth actions that are not permitted to be taken during the term of the Loan Agreement, including, without limitation, selling or disposing of assets, incurring additional indebtedness or non-permitted liens or encumbrances on our assets, making payments on subordinated indebtedness, and making investments other than permitted acquisitions and permitted investments, in each case, subject to specified exceptions, including, in the case of restrictions on incurrence of additional indebtedness, the ability to incur certain convertible indebtedness and enter into certain permitted royalty financing agreements. These covenants may limit our ability to engage in certain transactions that may be in our long-term best interest. The Loan Agreement also contains financial covenants, including a minimum liquidity requirement and, with respect to the fiscal year ending December 31, 2028 and then tested quarterly commencing with the fiscal quarter ending March 31, 2029, a minimum trailing twelve-month consolidated net product revenue covenant. As of June 30, 2026, we were in compliance with the covenants contained in the Loan Agreement; however, we may breach these covenants in the future. Our ability to comply with these covenants may be affected by events and factors beyond our control. In the event that we breach one or more covenants, the collateral agent may choose to declare an event of default and require that we immediately repay all amounts outstanding under the Loan Agreement, terminate any commitment to extend further credit, and foreclose on the collateral. The Loan Agreement also contains certain events of default, including failure to pay principal, interest, and other amounts when due, the breach of the covenants under the Loan Agreement, the occurrence of a material adverse change or a withdrawal event in respect of lorundrostat or any other pharmaceutical product from time to time manufactured or developed by us, certain attachments of our assets and restraints on our business, certain insolvency, liquidation, bankruptcy, or similar events, certain cross-defaults of third-party indebtedness and royalty revenue contracts, the failure to pay certain judgments, material misrepresentations, the loan documents ceasing to create a valid security interest in a material portion of the collateral, and the occurrence of a default under any intercreditor agreement, in each case subject to the grace periods, cure periods, and thresholds as specified in the Loan Agreement. Upon the occurrence of an event of default, the lenders may, among other things, accelerate our obligations under the Loan Agreement (including all obligations for principal, interest, and any applicable make-whole and prepayment premiums). We and the lenders also entered into a Guarantee and Security Agreement wherein we agreed to secure the Loan Agreement with all of our assets. The occurrence of any of these events could have a material adverse effect on our business, financial condition, results of operations, and prospects. If we default on any of our obligations under the Loan Agreement, the lenders could foreclose on their security interest and liquidate some or all of the collateral, including our intellectual property assets, which would harm our business, financial condition, results of operations, and prospects, and could require us to reduce or cease operations.