Financial Performance - The company incurred a net loss of $152,594,000 for the three months ended September 30, 2025, compared to a net loss of $1,298,000 for the same period in 2024, reflecting a substantial increase in losses[24]. - As of September 30, 2025, the Company reported cash and cash equivalents of $0.1 million and an accumulated deficit of $269.6 million, with operating losses of $154.3 million during the nine months ended[49]. - The company expects to incur significant expenses and increasing operating losses for the foreseeable future, with operating losses of $154.3 million during the nine months ended September 30, 2025[163]. - The company reported a net loss of $152.6 million for Q3 2025, compared to a net loss of $1.3 million for Q3 2024[185]. - The company anticipates continuing to incur net losses as it supports clinical development and seeks regulatory approvals for its product candidate, raising substantial doubt about its ability to continue as a going concern[200]. Assets and Liabilities - As of September 30, 2025, Semnur Pharmaceuticals reported total assets of $774,000, a significant decrease from $6,684,000 as of December 31, 2024[22]. - Total current liabilities increased to $10,032,000 as of September 30, 2025, compared to $35,000 as of December 31, 2024, highlighting a significant rise in short-term obligations[22]. - As of September 30, 2025, the company has promissory notes totaling $4.5 million due within a year and a long-term related party loan of $5.3 million due to Scilex[201]. - As of September 30, 2025, the Company reported total accrued expenses of $1,266,000, a significant increase from $35,000 as of December 31, 2024[101]. Research and Development - Research and development expenses rose to $1,143,000 for the three months ended September 30, 2025, up from $233,000 in the same period of 2024, indicating increased investment in product development[24]. - The company completed a pivotal Phase 3 study for its lead product candidate SP-102 and initiated a second Phase 3 study in September 2025, demonstrating progress in its clinical development pipeline[32]. - The company expects to receive approximately $20.0 million and $100.0 million in financing from PIPE SPA and Semnur/Biconomy SPA, respectively, if transactions close by December 31, 2025[194]. - Planned operating expenses for the next twelve months are estimated at approximately $21.0 million, including $10.0 million for clinical work[192]. Financing and Capital Structure - Proceeds from related party loans amounted to $9,911,000 for the nine months ended September 30, 2025, compared to $7,059,000 for the same period in 2024, indicating reliance on external financing[27]. - The issuance of preferred stock and common stock for a Debt Exchange Agreement amounted to $54,236,000, reflecting strategic financial maneuvers to manage debt[27]. - The Company plans to seek additional financing through equity offerings, debt financings, collaborations, and other capital sources to support its ongoing activities[50]. - The Company entered into a PIPE SPA on August 20, 2025, for the purchase of 1,250,000 shares of Common Stock at $16.00 per share, totaling $20.0 million, which has not yet closed as of September 30, 2025[42]. - A Semnur/Biconomy SPA was signed on September 23, 2025, for the sale of 6,250,000 shares of Common Stock at $16.00 per share, totaling $100.0 million, payable in Bitcoin, which has also not yet closed[45]. Stock-Based Compensation - The company reported stock-based compensation of $140,403,000 for the nine months ended September 30, 2025, compared to $523,000 for the same period in 2024, indicating a shift in compensation strategy[27]. - Total stock-based compensation recognized includes allocations for shared employees and expenses for grants made to consulting firms[144]. - Total stock-based compensation expense for the three months ended September 30, 2025, was $140,192,000, a decrease from $152,000,000 in the same period of 2024[145]. Corporate Governance and Control - The Company has assessed its ability to continue as a going concern for at least one year after the issuance date of the financial statements, raising substantial doubt about its ability to continue operations[48][51]. - The Company has identified a material weakness in its disclosure controls and procedures, concluding they were not effective at the reasonable assurance level as of September 30, 2025[218]. - Legacy Semnur identified material weaknesses in internal control over financial reporting for the years ended December 31, 2023 and 2022[219]. - Remediation measures include a comprehensive assessment of the control environment and the implementation of additional preventive and detective review controls[220]. Miscellaneous - The Company underwent a 160,000-for-1 forward stock split on August 30, 2024, increasing the number of outstanding shares from 1,000 to 160,000,000[52]. - The Company has determined it operates its business as a single operating segment focused on the development of SP-102, with net loss used to monitor budget versus actual results[74]. - The Company has not experienced losses on its cash account, which may exceed the Federal Depository Insurance Coverage of $250,000[67]. - The Company follows a three-level hierarchy for fair value measurements, with cash and cash equivalents classified as Level 1 assets[79].
Denali Capital Acquisition (DECA) - 2025 Q3 - Quarterly Report