Item 1A. Risk Factors
ITEM 1A. RISK FACTORS
We operate in an environment that involves a number of risks and uncertainties. Before making an investment decision you should carefully consider the risks described in Part I, Item 1A, “Risk Factors” of our Annual Report on Form 10-K for the year ended December 31, 2024, as filed with the SEC on March 31, 2025. In assessing the risk factors set forth in our Annual Report on Form 10-K for the year ended December 31, 2024, you should also refer to the other information included therein and in this Quarterly Report on Form 10-Q, including the supplemental risk factor below. In addition, we may be adversely affected by risks that we currently deem to be immaterial or by other risks that are not currently known to us. Due to these risks and uncertainties, known and unknown, our past financial results may not be a reliable indicator of future performance and historical trends should not be used to anticipate results or trends in future periods. The trading price of our common stock could decline due to any of these risks and you may lose all or part of your investment.
The Transaction with Novo Nordisk may not close when anticipated, or at all, and a significant delay or failure to close the Transaction would materially adversely affect our business, financial condition, results of operations, strategic plans, future operating performance, and, ultimately, ability to continue as a going concern.
We have entered into the APLA pursuant to which Novo Nordisk will receive exclusive global rights to develop and commercialize zaltenibart in all indications. Under the terms and conditions of the APLA, we will be eligible to receive up to a total of $2.1 billion in upfront and milestone-based payments, plus tiered royalties on net sales of commercialized products. This total includes an upfront payment of $240.0 million payable in cash upon Closing of the Transaction. The receipt of this upfront payment would enable us to (i) repay in full all obligations outstanding under our Credit Agreement, (ii) repay at maturity the remaining $17.1 million principal balance of our 2026 Notes, and (iii) provide sufficient capital for at least 12 months of post-closing operations, including the potential launch of narsoplimab. We do not have sufficient cash on hand to fund these expenses without receipt of the upfront payment from Novo Nordisk.
Completion of the Transaction is subject to customary closing conditions, including the expiration or early termination of the ongoing waiting period under the Hart-Scott-Rodino Antitrust Improvements Act of 1976, as amended (“HSR Act”). The Transaction is expected to close in the fourth quarter of 2025. However, there can be no assurance that the waiting period under the HSR Act will expire or be terminated or that any other closing conditions will be satisfied. The pendency of the Transaction may create uncertainty or disruption in our business relationships, including with personnel and vendors, and could divert management’s attention from ongoing operations. If the Transaction does not close, whether due to the inability to obtain HSR Act clearance or the failure of any other closing condition, we will not receive the upfront payment and, further, will not realize the anticipated benefits of the Transaction as a whole. This would materially adversely affect our business, financial condition, and results of operations, including our ability to comply with affirmative covenants under our Credit Agreement. It would also materially adversely affect our strategic plans, including those related to the potential launch of narsoplimab, and would, in turn, materially adversely affect our future operating performance. Ultimately, the failure to close the Transaction may materially adversely affect our ability to continue as a going concern.
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