Product Development and Clinical Trials - SP-102 is being developed as an injectable viscous gel formulation of a corticosteroid, targeting the unmet needs in acute and chronic pain management, specifically for sciatica, with over 12 million off-label epidural steroid injections administered annually in the U.S.[23] - The pivotal Phase 3 study for SP-102 achieved primary and secondary endpoints, showing a statistically significant reduction in pain intensity with a least square mean treatment difference of -0.52 units (P=0.002) compared to placebo[24] - The key secondary endpoint of mean change in Oswestry Disability Index (ODI) showed a LS mean treatment difference of -3.38 units (P=0.015), with a reduction of -8.88 points from baseline, exceeding the minimal clinically important difference[25] - Following a Type C meeting with the FDA in November 2023, the company was advised to conduct a confirmatory trial due to insufficient data from the initial study, leading to the design of the Phase 3 CLEAR-2 trial[26] - The CLEAR-2 trial is expected to enroll approximately 700 patients and will include a larger safety database to validate the safety and efficacy of SP-102, with a primary endpoint of average daily NPRS pain over four weeks[26] - The company anticipates completing the CLEAR-2 trial by 2027 and aims to submit a 505(b)(2) NDA to the FDA for SP-102 approval, targeting a commercial launch in 2028 if approved[27] - SP-102 has received fast track designation from the FDA, which may facilitate its development and regulatory review process, although it does not guarantee marketing approval[29] - SP-102 is a Phase 3 sterile dexamethasone sodium phosphate viscous gel formulation containing 10 mg of dexamethasone at a concentration of 5 mg/mL, designed for epidural injection[49] - The pivotal Phase 3 CLEAR trial enrolled 401 subjects across over 40 clinical sites in the U.S., evaluating the analgesic effect of SP-102 compared to placebo[52][55] - The primary endpoint showed a statistically significant reduction in average daily NPRS pain score of -1.81 for SP-102 versus -1.29 for placebo, with a treatment difference of -0.52 (P=0.002)[60][62] - SP-102 demonstrated a significant improvement in the key secondary endpoint of mean change in ODI from baseline, with a treatment difference of -3.38 (P=0.015)[64] - The time to repeat injection for SP-102 was 84 days compared to 58 days for placebo (P=0.001), indicating prolonged pain relief[64] - No serious adverse events (SAEs) related to SP-102 were reported, with a slightly higher proportion of treatment-emergent adverse events (TEAEs) in the SP-102 group (29.7%) compared to placebo (21.1%)[64] - SP-102 is expected to improve tolerability and pain relief by avoiding neurotoxic preservatives and particulates found in currently used steroids[50][51] - If approved, SP-102 could be the first FDA-approved epidural steroid injection product for sciatica, potentially reducing the need for spinal surgery and opioid use[51] - The Phase 3 study results were published in PAIN® Journal in June 2024, highlighting the clinical benefits of SP-102[53][59] - SP-102 demonstrated a mean change in NPRS Average Pain Score in the affected leg of -1.81 compared to -1.29 for placebo, with a statistically significant difference of -0.55 (P=0.003) [66] - The ODI total score showed a mean change of -8.88 for SP-102 versus -5.48 for placebo, resulting in a significant difference of -3.38 (P=0.015) [66] - In the ITT population, 35.1% of patients on SP-102 reported being "very much improved" or "much improved" compared to 19.6% for placebo (P<0.001) [68] - The time to repeat injection for SP-102 was significantly longer, with a mean of 67.0 days compared to 57.8 days for placebo (P=0.001) [70] - A total of 66.3% of patients receiving SP-102 required a repeat injection, while 76.4% of those on placebo did, indicating a significant difference (P=0.026) [70] - For a 30% reduction in pain, 43.6% of SP-102 patients responded positively compared to 28.6% for placebo (P=0.002) [71] - The Phase 1 trial showed a Tmax of 4 hours for SP-102 compared to 15 minutes for intravenous dexamethasone, indicating a prolonged effect [82] - SP-102 maintained analgesic effects throughout a one-month observation period, with continuous reduction in pain reported by all subjects [83] - The pharmacokinetics of SP-102 showed similar systemic exposure to dexamethasone as intravenous administration, with a mean AUCinf of 0.916 µg*h/mL for SP-102 [83] - Toxicology studies indicated no new unexpected findings, supporting the selection of a 10mg dexamethasone dose for further clinical studies [86] Market Potential and Financial Projections - The U.S. ESI market is projected to grow at an average rate of 3.6% annually through 2027, with SP-102 expected to capture a maximum market share of approximately 33%[40] - By the fifth year post-launch, SP-102 sales in sciatica are projected to reach between $1.5 billion and $2.0 billion annually, assuming regulatory approval in 2027 and commercial launch in 2028[41] - The estimated lifetime incidence of sciatica in the U.S. ranges from 13% to 40%, with over 4.8 million patients expected to suffer from sciatica in 2024[39] - Scilex has successfully launched three commercial non-opioid pain management products in the past five years, leveraging its integrated commercial infrastructure[31] - The company plans to file for a separate J code for SP-102 to facilitate reimbursement and faster revenue uptake following FDA approval[30] - Current opioid prescriptions for low back pain have increased significantly, highlighting the need for effective non-opioid alternatives like SP-102[30] - The company aims to expand its product portfolio by developing or acquiring non-opioid assets to address unmet pain management needs[30] Corporate Structure and Agreements - The Transition Services Agreement with Scilex allows the company to utilize Scilex's resources for finance, HR, and commercialization support for three years post-business combination[31] - The company has invested significantly in building its intellectual property portfolio and infrastructure since its founding in 2013, conducting various pharmacokinetic and toxicology studies[22] - The company aims to leverage the regulatory approval pathway under Section 505(b)(2) of the FDCA for its product candidate, SP-102[28] - Scilex agreed to pay up to $280.0 million in contingent cash consideration to former holders of Legacy Semnur's capital stock based on milestone achievements[114] - Payments include $40.0 million upon FDA approval of a New Drug Application (NDA) and additional payments based on cumulative net sales milestones of $100.0 million, $250.0 million, $500.0 million, and $750.0 million[114] - Legacy Semnur has not triggered any of the aforementioned payments to date[114] - The Shah Assignment Agreement stipulates royalties of 1.5% on net sales up to $250.0 million and 2.5% on net sales above that threshold, with no payments triggered to date[117] - The company's patent portfolio includes approximately seven issued and unexpired U.S. patents and two pending U.S. patent applications as of December 31, 2025[122] - SP-102 is protected by U.S. patents that expire in 2036, covering formulations and methods of treatment[123] - The company is in discussions with Sanofi to secure future supply requirements for sodium hyaluronate, a key excipient for SP-102, after the previous supply agreement with Genzyme ended on May 31, 2024[127] - The company initiated the Phase 3 CLEAR 2 trial for SP-102 in September 2025[137] Regulatory Environment - The FDA requires at least two adequate and well-controlled Phase 3 clinical trials for NDA approval, although a single trial may suffice under certain conditions[136] - The FDA has a goal of 10 months from the date of filing a standard NDA for a new molecular entity to review and act on the submission, typically taking 12 months from submission[144] - The FDA may require a Risk Evaluation and Mitigation Strategy (REMS) if deemed necessary, which could restrict commercial promotion and distribution of the product[146] - The FDA conducts a preliminary review of all NDAs within the first 60 days after submission to determine completeness for substantive review[144] - If a Complete Response Letter is issued, the sponsor must address deficiencies and resubmit the NDA, which may require additional clinical data[148] - The FDA may impose post-approval requirements, including Phase 4 clinical trials, to monitor the product's safety and effectiveness after commercialization[158] - Drug product manufacturers must register with the FDA and are subject to periodic inspections for compliance with cGMP regulations[159] - The FDA's fast track designation expedites the review process for products intended to treat serious conditions and address unmet medical needs[150] - Products may also be eligible for priority review, which aims to complete the review within six months compared to ten months for standard NDAs[152] - The breakthrough therapy designation allows for more intensive FDA interaction and guidance for products showing substantial improvement over existing therapies[154] - The FDA may withdraw approval if compliance with regulatory standards is not maintained or if new risks are discovered post-approval[158] - The Hatch-Waxman Amendments allow for three types of NDAs, including 505(b)(1) and 505(b)(2) NDAs, which enable applicants to rely on existing FDA findings for approval[160] - Section 505(j) establishes an abbreviated approval process for generic drugs through ANDAs, requiring bioequivalence testing to confirm therapeutic equivalence[161] - NDA sponsors must list all relevant patents with the FDA, and upon ANDA submission, must certify the status of these patents, which can affect approval timelines[162] - The Hatch-Waxman Amendments provide five years of exclusivity for new drug products containing new chemical entities and three years for certain changes requiring new clinical trials[164] Market Dynamics and Compliance - Third-party payors significantly influence product sales through coverage and reimbursement decisions, which can vary widely among different payors[165] - The pharmaceutical industry faces pricing pressures due to managed healthcare trends and government interest in cost containment, which may adversely affect net revenue[166] - In the EEA, governments control pharmaceutical pricing and reimbursement, creating barriers for new product entry and influencing market dynamics[167] - The Affordable Care Act (ACA) has introduced significant changes to healthcare financing, impacting the pharmaceutical industry through various provisions[168] - Legislative changes since the ACA, such as the Budget Control Act of 2011, have reduced Medicare payments, potentially affecting the ability to develop and market new products[171] - The Inflation Reduction Act of 2022 allows CMS to negotiate prices for certain high-cost drug products starting with 10 products in 2026, increasing to 20 products by 2029[172] - Medicare beneficiaries' annual out-of-pocket drug expenses are capped at $2,000 under the new legislation[172] - Pharmaceutical manufacturers face civil monetary penalties for non-compliance with negotiated pricing and for price increases exceeding inflation rates[172] - The FDA authorized Florida's drug importation program in January 2024, allowing importation of certain prescription drugs from Canada[172] - The implementation of healthcare reforms may lead to reduced reimbursement rates from Medicare, impacting future revenue[174] - Compliance with various federal and state regulations, including the Anti-Kickback Statute and the False Claims Act, is critical to avoid substantial penalties[175][178] - The Physician Payments Sunshine Act requires manufacturers to report payments to physicians and teaching hospitals, with extended obligations for non-physician providers effective January 1, 2022[184] - Several states have enacted laws requiring pharmaceutical companies to establish marketing compliance programs and report on sales and marketing activities[186] - Compliance with evolving data privacy laws, such as the CCPA and CPRA, imposes significant operational costs and risks for the company[181][183] - The company must adhere to government price reporting requirements under Medicaid and Medicare, necessitating substantial rebates and discounts[187] - The company may face significant penalties, including fines and operational restrictions, if found in violation of federal and state laws[188] Company Structure and Workforce - As of December 31, 2025, the company has 10 full-time employees, including three with M.D.s or Ph.D.s, and relies on 15 employees and contractors from Scilex for operations[210] - Scilex has 28 full-time employees, with four in R&D, seven in sales and marketing, and 17 in general management and administration[210] - The Transition Services Agreement with Scilex allows the company to utilize Scilex's employees for various business functions on a cost plus 10% basis, capped at $2.0 million per annum until the Scilex-Oramed Note of $101.9 million is fully paid[211] - The Transition Services Agreement is set for three years, providing sufficient time for the company to develop its commercial infrastructure[211] - The company was incorporated as "Denali Capital Acquisition Corp." on January 5, 2022, and changed its name to "Semnur Pharmaceuticals, Inc." on September 22, 2025, following a business combination[212] - The company qualifies as an "emerging growth company," allowing it to benefit from various reporting exemptions[212] - The company is also classified as a "smaller reporting company," which permits reduced disclosure obligations, including only two years of audited financial statements[213] - The company files reports with the SEC, which can be accessed on the SEC's website[214]

Table of Contents As filed with the U.S. Securities and Exchange Commission on December 19, 2025 Registration No. 333-290995 UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 Amendment No. 1 to FORM S-1 REGISTRATION STATEMENT UNDER THE SECURITIES ACT OF 1933 Semnur Pharmaceuticals, Inc. (Exact name of registrant as specified in its charter) (State or other jurisdiction of incorporation or organization) Delaware 2836 98-1659463 (Primary Standard Industrial Classification Code Number) Pa ...

Financial Performance - The company reported 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[24]. - The company incurred a net loss of $152.594 million for the three months ended September 30, 2025, compared to a net loss of $1.298 million for the same period in 2024[154]. - The Company will require additional financing through equity offerings, debt financings, or collaborations to support ongoing activities[50]. - The company anticipates continuing to incur net losses into the foreseeable future, raising substantial doubt about its ability to continue as a going concern[200]. - The Company is dependent on Scilex for services and funding until external financing is secured, and anticipates significant expenses and operating losses as it seeks regulatory approval for SP-102[49][50]. Assets and Liabilities - As of September 30, 2025, total assets decreased to $774,000 from $6,684,000 as of December 31, 2024[22]. - Total current liabilities rose significantly to $10,032,000 as of September 30, 2025, compared to $35,000 as of December 31, 2024[22]. - The company had cash and cash equivalents of $0.1 million and an accumulated deficit of $269.6 million as of September 30, 2025[190]. - 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 cash and cash equivalents of $0.1 million and an accumulated deficit of $269.6 million, with operating losses of $154.3 million for the nine months ended[49]. Research and Development - Research and development expenses increased to $1,143,000 for the three months ended September 30, 2025, up from $233,000 in the same period of 2024[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[32]. - The Company completed a pivotal Phase 3 study for SP-102, which demonstrated significant pain reduction in sciatica patients, with results published in June 2024[161]. - The Company initiated a second Phase 3 study for SP-102 in September 2025, aiming to further validate its efficacy[161]. - Planned operating expenses for the next twelve months are estimated at approximately $21.0 million, including $10.0 million for clinical work[192]. Stock and Financing - The company issued 5,423,606 shares of preferred stock as part of a Debt Exchange Agreement, valued at $54,236,000[27]. - 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 closed as of September 30, 2025[45]. - The Company expects to receive financing of $20.0 million and $100.0 million from PIPE SPA and Semnur/Biconomy SPA, respectively, if transactions close by December 31, 2025[194]. - The total loans from Scilex Holding Company amounted to $10.314 million for the nine months ended September 30, 2025, compared to $7.582 million in the same period of 2024[150]. Corporate Structure and Governance - The Company completed a business combination with Legacy Semnur on September 22, 2025, resulting in the issuance of 200,000,000 shares of Common Stock at an exchange ratio of 1.25 shares per Legacy Semnur common stock[34][36][37]. - The Business Combination was treated as a reverse recapitalization, with Denali being considered the "acquired" company for financial reporting purposes[40]. - The Sponsor Support Agreement requires the Sponsor and directors to vote in favor of the Merger Agreement and against any actions that would impede the business combination[139]. - Scilex has the right to designate directors to the Board of Directors and to approve certain actions, including amendments to the Certificate of Designations[142]. - Legacy Semnur identified material weaknesses in internal control over financial reporting for the years ended December 31, 2023 and 2022[219]. Legal and Compliance - The Company has no material legal proceedings as of September 30, 2025, indicating a stable legal environment[102]. - The company has identified a material weakness in its disclosure controls and procedures, which were not effective at the reasonable assurance level as of September 30, 2025[218]. - The material weaknesses were related to ineffective control activities in the preparation of carve-out financial statements and stock-based compensation expense[220]. - Remediation measures include a comprehensive assessment of the control environment and the implementation of additional preventive and detective review controls[220]. - External accounting experts will be utilized as appropriate to address the identified weaknesses[220]. Stock-Based Compensation - Stock-based compensation for the nine months ended September 30, 2025, was $140,403,000, compared to $523,000 for the same period in 2024[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 million, a decrease from $152 million in the same period of 2024[145]. - The Company accounts for stock-based compensation based on the fair value of the award determined using the Black-Scholes option pricing model[87]. - The holders of Series A Preferred Stock are entitled to a liquidation preference of at least $10.00 per share plus accrued dividends in the event of liquidation[122].

Table of Contents As filed with the U.S. Securities and Exchange Commission on October 21, 2025 Registration No. 333- UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM S-1 REGISTRATION STATEMENT UNDER THE SECURITIES ACT OF 1933 Semnur Pharmaceuticals, Inc. (Exact name of registrant as specified in its charter) (State or other jurisdiction of incorporation or organization) Delaware 2836 98-1659463 (Primary Standard Industrial Classification Code Number) 960 San Antonio Road, Palo A ...

Financial Performance - The company reported a net loss of $579,725 for the six months ended June 30, 2025, compared to a net income of $713,242 for the same period in 2024[17]. - Basic and diluted net loss per non-redeemable ordinary share was $(0.24) for the six months ended June 30, 2025, compared to $(0.12) for the same period in 2024[17]. - For the three months ended June 30, 2025, the company reported a net loss of $385,122, compared to a net income of $448,912 for the same period in 2024, indicating a significant decline in performance[112]. - The net loss including accretion of temporary equity for the six months ended June 30, 2025, was $405,826, compared to a net loss of $341,245 for the same period in 2024[112]. - For the six months ended June 30, 2025, the company had a net loss of $579,725, with formation and operating expenses totaling $621,457 and interest expense of $55,319, offset by income from investments of $97,051[200]. Assets and Liabilities - As of June 30, 2025, total assets amounted to $562,462, a significant decrease from $9,037,873 as of December 31, 2024[14]. - Total current liabilities increased to $8,268,951 as of June 30, 2025, compared to $7,547,084 as of December 31, 2024[14]. - Cash on hand decreased to $126 as of June 30, 2025, from $16,868 at the end of 2024[14]. - The company had cash and investments held in trust of $548,318 as of June 30, 2025, down from $9,021,005 at the end of 2024[14]. - As of June 30, 2025, the Company reported a working deficit of $8,254,807, indicating significant liquidity challenges[65]. Business Combination and IPO - The Company raised gross proceeds of $82.5 million from the IPO by selling 8,250,000 Public Units at $10.00 each, with each unit consisting of one Class A ordinary share and one redeemable warrant[27]. - Following the IPO, a total of $84.15 million of net proceeds was deposited into a Trust Account, which is invested in U.S. government securities or money market funds[28]. - The Company has extended the deadline to consummate a business combination to July 11, 2024, with provisions for monthly extensions funded by the Sponsor[28]. - The total consideration for the merger with Semnur Pharmaceuticals is set at $2,500,000,000, with an exchange ratio of 250 million New Semnur Common Shares to be issued[51]. - The Company plans to redeem Public Shares if it fails to complete the business combination within the specified period, with a per-share price based on the Trust Account balance[42]. Compliance and Listing - The Company received a notice from Nasdaq regarding non-compliance with the MVLS Rule, requiring a minimum MVLS of $50 million for continued listing[78]. - The compliance period to regain Nasdaq listing compliance ended on June 30, 2025, with the Company failing to meet the required metrics[79]. - The Company’s securities were delisted from Nasdaq on April 16, 2025, and began trading on OTC markets the following day[80]. Financing and Loans - The outstanding amount under Working Capital Loans reached $1,574,970 as of June 30, 2025, reflecting reliance on financing from the Sponsor[69]. - The Company issued a Convertible Promissory Note to the Sponsor for up to $180,000, with an initial balance of $15,037[34]. - The Company issued a Convertible Promissory Note with an initial principal balance of $412,500 and additional loans totaling $1,000,000 were agreed upon by January 24, 2025[139]. Shareholder Actions - On October 11, 2023, shareholders redeemed approximately $40.5 million (about $10.92 per share) from the Trust Account, leaving 4,537,829 public shares outstanding[31]. - Shareholders redeemed 3,785,992 public shares for approximately $43.4 million, resulting in a pro rata value of about $11.47 per share[183]. Tax and Regulatory Matters - The Cayman Islands is the company's only major tax jurisdiction, with no taxation imposed on income for the six months ended June 30, 2025[121]. - The company had no unrecognized tax benefits and no amounts accrued for interest and penalties as of June 30, 2025[118]. Operational Status - The company has not commenced any operations as of June 30, 2025, and is focused on identifying a target company for a business combination[25]. - The Company anticipates using funds in the Trust Account primarily for completing a Business Combination and financing operations of the target business[63].

Financial Performance - The company reported a net loss of $194,603 for the three months ended March 31, 2025, compared to a net income of $264,330 for the same period in 2024, indicating a significant decline in performance[15]. - The basic and diluted net loss per non-redeemable ordinary share was $(0.10) for the three months ended March 31, 2025, compared to $(0.08) for the same period in 2024, showing a deterioration in earnings per share[15]. - For the three months ended March 31, 2025, the net loss was $194,603, compared to a net income of $264,330 for the same period in 2024[162]. - The Company had a working deficit of $7,848,981 as of March 31, 2025[62]. - Total formation and operating costs decreased to $246,600 for the three months ended March 31, 2025, from $368,252 in the same period of 2024, representing a reduction of approximately 33%[162]. - Interest earned on investments held in the Trust Account was $78,971 for the three months ended March 31, 2025, a significant decrease from $653,885 in the same period of 2024[162]. Assets and Liabilities - As of March 31, 2025, total assets amounted to $9,147,903, a slight increase from $9,037,873 as of December 31, 2024, reflecting a growth of approximately 1.22%[13]. - Total current liabilities increased to $7,851,717 as of March 31, 2025, up from $7,547,084 as of December 31, 2024, representing an increase of about 4.03%[13]. - The company had a total shareholders' deficit of $(10,736,481) as of March 31, 2025, compared to $(10,417,716) as of December 31, 2024, indicating an increase in deficit of about 3.06%[13]. - As of March 31, 2025, the Trust Account held $9,145,167 solely in cash, intended for the Business Combination[59]. - As of March 31, 2025, the Company had cash of $2,736 outside of the Trust Account[60]. IPO and Business Combination - The company completed its IPO on April 11, 2022, raising gross proceeds of $82,500,000 from the sale of 8,250,000 units[25]. - The Company deposited a total of $84,150,000 into the Trust Account following the IPO on April 11, 2022[26]. - The Company has identified Semnur Pharmaceuticals, Inc. as a potential target for a business combination[23]. - The Company plans to extend the deadline for consummating a business combination from April 11, 2025, to December 11, 2025, with provisions for monthly extensions[34]. - The Company entered into a new Merger Agreement with Semnur Pharmaceuticals on August 30, 2024, with a total consideration of $2,500,000,000[48][49]. - The Merger Agreement stipulates that Semnur's equity value is set at $2,500,000,000, with shares converted based on an Exchange Ratio[183]. Shareholder Actions and Redemptions - On October 11, 2023, shareholders redeemed approximately $40.5 million (about $10.92 per share) from the Trust Account, leaving 4,537,829 public shares outstanding[29]. - As of July 10, 2024, shareholders redeemed approximately $43.4 million (about $11.47 per share) from the Trust Account, resulting in 751,837 public shares remaining[31]. - On April 11, 2025, shareholders redeemed 708,098 public shares for approximately $8.6 million, resulting in a pro rata payment of about $12.17 per share[164]. - Following redemptions, the Company had 43,739 public shares outstanding as of April 11, 2025[164]. Compliance and Regulatory Issues - The Company received a notice from Nasdaq on October 2, 2024, indicating non-compliance with the MVLS Rule and Total Assets Rule, requiring a minimum MVLS of $50 million[76]. - The Company was notified on April 2, 2025, that it had not regained compliance with Nasdaq Listing Rules and faced delisting[78]. - The Company was unable to regain compliance with Nasdaq Listing Rules by March 31, 2025, leading to the delisting of its securities on April 16, 2025[172]. Financing and Debt - The Company issued a convertible promissory note totaling up to $180,000 to the Sponsor on July 10, 2024, with an initial balance of $15,037[32]. - The outstanding amount under Working Capital Loans reached $1,408,200 for Convertible Promissory Note 1 and $115,037 for Convertible Promissory Note 2 as of March 31, 2025[65]. - The Company has accrued interest expense of $91,764 related to the Working Capital Loans as of March 31, 2025[136]. - The outstanding principal balance of the convertible promissory note held by FutureTech was $1,275,000 as of March 31, 2025[191]. Future Outlook and Concerns - The Company has raised concerns regarding its ability to continue as a going concern through December 11, 2025, if a Business Combination is not consummated[72]. - Management believes there may not be sufficient working capital to meet needs through the consummation of the initial business combination[206]. - The Company may need to obtain additional financing to complete the business combination or due to obligations to redeem public shares[208].

IPO and Financial Proceeds - The company completed its IPO on April 11, 2022, raising gross proceeds of $82.5 million from the sale of 8,250,000 units at $10.00 per unit[23]. - A total of $84,150,000 of the net proceeds from the IPO and Private Placement Units was deposited in the Trust Account, with transaction costs amounting to $5,105,315[94]. - The company completed a Private Placement of 510,000 Private Placement Units at a purchase price of $10.00 per unit, generating gross proceeds of $5.1 million[91]. - The underwriters received a cash underwriting discount of $1,650,000 and a deferred fee of $2,887,500, contingent upon the completion of a business combination[145]. - The company incurred $5,105,315 in transaction costs related to the IPO, including $1,650,000 in underwriting fees and $2,887,500 in deferred underwriting fees[132]. Business Combination and Extensions - The company extended the deadline to consummate an initial business combination from October 11, 2023, to July 11, 2024, with the option for up to nine one-month extensions[25]. - The deadline for completing an initial business combination has been extended to April 11, 2025, with the possibility of further monthly extensions[56]. - The company entered into a letter of intent with Semnur for a potential business combination on July 2, 2024[29]. - The Longevity Merger Agreement was terminated on June 26, 2024, leading to the withdrawal of the registration statement initially filed with the SEC[28]. - The Business Combination must meet the Nasdaq requirement of having a total aggregate fair market value of at least 80% of the Trust Account assets[55]. Shareholder Redemptions - Following the Extension Meeting on October 11, 2023, shareholders redeemed 3,712,171 public shares, resulting in approximately $40.5 million (approximately $10.92 per share) being removed from the Trust Account[26]. - On July 10, 2024, shareholders redeemed 3,785,992 public shares, leading to approximately $43.4 million (approximately $11.47 per share) being withdrawn from the Trust Account[30]. - Approximately $43.4 million was removed from the Trust Account due to shareholder redemptions, leaving 751,837 public shares outstanding[109]. - Following redemptions, there are 751,837 public shares outstanding[48]. Financial Performance - The Company had a net loss of $167,306 for the year ended December 31, 2024, primarily due to formation and operating expenses of $1,649,106 and interest expense of $96,242, partially offset by income earned on investments held in the Trust Account of $1,578,042[122]. - For the year ended December 31, 2023, the Company reported a net income of $632,536, primarily from income earned on investments held in the Trust Account amounting to $3,843,271, offset by formation and operating expenses of $3,173,826 and interest expense of $36,909[123]. - For the year ended December 31, 2024, net cash used in operating activities was $753,296, primarily due to a net loss and changes in current assets and liabilities[124]. - For the year ended December 31, 2024, net cash provided by financing activities was $42,859,628, primarily due to proceeds from the issuance of a promissory note to a related party[128]. Corporate Structure and Governance - The board of directors consists of three members, with directors serving a two-year term[172]. - The audit committee is comprised of independent directors, including Huifeng Chang, Jim Mao, and Kevin Vassily, with Kevin Vassily serving as the Chair[175]. - Lei Huang serves as the Chief Executive Officer and has been with the company since its inception[166]. - You ("Patrick") Sun has served as the Chief Financial Officer since the company's inception and has extensive experience in banking and asset management[168]. - The audit committee is responsible for monitoring the independence of the independent registered public accounting firm and pre-approving all audit services[176]. Risks and Challenges - The company has encountered intense competition from other entities seeking similar business combinations, which may limit its ability to acquire larger target businesses[73]. - The company has no operating history and no revenues, which presents a challenge in evaluating its ability to achieve its business objectives[76]. - Management expressed substantial doubt about the Company's ability to continue as a going concern through April 11, 2025, if a business combination is not consummated[139]. - The company is subject to a potential delisting from Nasdaq if it fails to complete a business combination by April 7, 2025[77]. Compliance and Regulatory Matters - The Company is required to maintain a Minimum Value of Listed Securities (MVLS) of $50 million for continued listing on Nasdaq, with a compliance deadline of August 20, 2024[100]. - The Company has 180 days to regain compliance with Nasdaq Listing Rules, with MVLS needing to close at or above $50 million for ten consecutive business days[102]. - The company is classified as an "emerging growth company" and will maintain this status until it achieves total annual gross revenue of at least $1.235 billion or the market value of its ordinary shares exceeds $700 million[70]. - The company has no approved plan to extend the business combination deadline beyond April 11, 2025[221]. Internal Controls and Audit - Management assessed the effectiveness of internal control over financial reporting as of December 31, 2024, and determined it was effective[158]. - There were no changes in internal control over financial reporting during the quarter ended December 31, 2024, that materially affected its effectiveness[160]. - The audit committee is responsible for the pre-approval of audit and permitted non-audit services performed by the independent auditor[209]. Miscellaneous - The company has not declared or paid any dividends on its ordinary shares and does not anticipate doing so in the foreseeable future[88]. - The company has not encountered any cybersecurity incidents since its IPO and does not consider itself to face significant cybersecurity risk[80]. - The company has no material litigation or governmental proceedings currently pending against it[82]. - The company has no off-balance sheet arrangements as of December 31, 2024, and does not participate in transactions that create variable interest entities[142].

Financial Performance - Net loss for the three months ended September 30, 2024, was $40,861 compared to a net income of $630,586 for the same period in 2023[15]. - Loss from operations for the nine months ended September 30, 2024, was $749,389, down from $2,991,344 in the same period of 2023, indicating a significant reduction in operational losses[15]. - For the nine months ended September 30, 2024, the net income was $672,381, a significant increase from $79,193 for the same period in 2023, representing a growth of approximately 748%[23]. - The basic and diluted net loss per non-redeemable ordinary share improved from $(0.12) in Q3 2023 to $(0.08) in Q3 2024[15]. - The basic and diluted net income per share for the three months ended September 30, 2024, was $0.14, compared to a net loss of $(0.08) for the same period in 2023[115]. - The net loss for the nine months ended September 30, 2023, was $1,345,643, compared to a net income of $672,381 for the same period in 2022[113]. Assets and Liabilities - Total current assets decreased from $209,440,000 as of December 31, 2023, to $35,428,000 as of September 30, 2024, representing a decline of approximately 83.1%[13]. - Total assets decreased from $50,687,403 to $8,924,547, a reduction of about 82.4%[13]. - Cash and investments held in the Trust Account decreased from $50,477,963 to $8,889,119, a decline of approximately 82.4%[13]. - Total liabilities increased from $8,491,479 to $9,481,571, an increase of about 11.7%[13]. - Accumulated deficit increased from $(8,282,297) as of December 31, 2023, to $(9,446,400) as of September 30, 2024, reflecting a worsening financial position[13]. Cash Flow - Net cash used in operating activities for the nine months ended September 30, 2024, was $(655,877), compared to $(473,787) for the same period in 2023, indicating a decline in cash flow from operations[23]. - The company provided $43,425,328 in cash from investing activities during the nine months ended September 30, 2024, compared to $(825,000) in the same period of 2023, showing a positive shift in investment cash flow[23]. - The total cash at the end of the period was $14,287, up from $13,460 at the end of September 30, 2023[23]. Business Combination and Agreements - The company extended the deadline to consummate a business combination from October 11, 2023, to July 11, 2024, with additional deposits of $150,000 into the Trust Account[29]. - The Company entered into a Merger Agreement with Semnur Pharmaceuticals, with a total consideration of $2,500,000,000 to be paid at Closing[53]. - The Company intends to seek alternative ways to consummate an initial business combination following the termination of the Longevity Merger Agreement[50]. - The Company plans to apply substantially all net proceeds from the IPO toward consummating a business combination, which must involve businesses with a fair market value of at least 80% of the Trust Account assets[41]. - The Company has a deadline of April 11, 2025, to complete a Business Combination, or it will cease operations except for winding up[75]. Shareholder Information - As of September 30, 2024, the company had 4,537,829 public shares outstanding after redemptions, down from 3,712,171 public shares redeemed for approximately $40.5 million[32]. - The Company will allow Public Shareholders to redeem their shares at a price of approximately $10.20 per Public Unit prior to the initial Business Combination[42]. - A shareholder meeting on October 11, 2023, approved the elimination of the limitation on redeeming Public Shares that would cause net tangible assets to fall below $5,000,001[42]. - The Company’s Class A ordinary shares subject to possible redemption decreased from 4,537,829 shares on December 31, 2023, to 751,837 shares on September 30, 2024[105]. - Shareholders redeemed 3,785,992 public shares for approximately $43.4 million, resulting in about $11.47 per share being removed from the Trust Account[190]. Financing and Debt - The company issued a convertible promissory note totaling $180,000 to the Sponsor, with an initial balance of $15,036.74, to support its operations[35]. - The Company incurred $5,105,315 in transaction costs related to the IPO, including $1,650,000 in underwriting fees[61]. - As of September 30, 2024, the Company had $1,308,200 outstanding under Working Capital Loans in the form of Convertible Promissory Notes issued to the Sponsor[69]. - The principal amount of the Sponsor's convertible promissory notes increased to $1,323,237 due to an aggregate loan of $480,737 during the nine months ended September 30, 2024[202]. Compliance and Regulatory Matters - The Company received a notification from Nasdaq on February 22, 2024, indicating that its Minimum Value of Listed Securities (MVLS) was below the required $50 million for 30 consecutive business days[78]. - The Company has until August 20, 2024, to regain compliance with the MVLS requirement by closing at or above $50 million for a minimum of ten consecutive business days[78]. - The Company is classified as an "emerging growth company," allowing it to take advantage of certain reporting exemptions[84]. Operational Status - The company has not commenced any operations as of September 30, 2024, and does not expect to generate operating revenues until after completing a business combination[26]. - The Company has incurred increased expenses due to being a public company, including legal and financial reporting costs[204]. - The Company has not generated any operating revenues to date and does not expect to do so until after completing its initial business combination[204].

Financial Performance - The company experienced a net income of $448,912 for the three months ended June 30, 2024, compared to a net income of $457,709 for the same period in 2023, indicating a slight decrease of about 0.2%[13] - Basic and diluted net income per redeemable ordinary share was $0.13 for the three months ended June 30, 2024, compared to $0.10 for the same period in 2023, showing an increase of 30%[13] - The company reported a loss from operations of $168,186 for the three months ended June 30, 2024, significantly lower than the loss of $563,701 for the same period in 2023, indicating an improvement of approximately 70%[13] - For the six months ended June 30, 2024, the company reported a net income of $713,242 compared to a net loss of $551,393 for the same period in 2023[17] - The net loss for the six months ended June 30, 2024, was $341,245, including an accretion of temporary equity to redemption value of $790,157[79] Liabilities and Shareholder Equity - As of June 30, 2024, the company reported total liabilities of $9,206,623, an increase from $8,491,480 as of December 31, 2023, reflecting a growth of approximately 8.4%[11] - The accumulated deficit increased to $(9,163,097) as of June 30, 2024, from $(8,282,297) as of December 31, 2023, representing a deterioration of approximately 10.6%[12] - The company’s total shareholders' deficit was $(9,162,840) as of June 30, 2024, compared to $(8,282,040) as of December 31, 2023, indicating a decline of about 10.6%[12] - The total current liabilities amounted to $6,319,123 as of June 30, 2024, up from $5,603,980 as of December 31, 2023, marking an increase of about 12.7%[11] Trust Account and Cash Management - The Company has placed a total of $84,150,000 in the Trust Account following the IPO, with $1,515,795 in cash held outside the Trust Account for working capital purposes[42] - As of June 30, 2024, the Trust Account holds $52,072,006 solely in cash in an interest-bearing demand deposit account[43] - The Company liquidated U.S. government securities in the Trust Account and now holds funds in an interest-bearing bank deposit account yielding approximately 4.5% per annum[129] - Approximately $40.5 million was removed from the Trust Account to pay shareholders who redeemed their public shares, resulting in 4,537,829 public shares outstanding[24] - On July 10, 2024, shareholders redeemed approximately $43.4 million (approximately $11.47 per share) from the Trust Account, leaving 751,837 public shares outstanding[27] Business Combination and Operations - The company has not commenced any operations and does not expect to generate operating revenues until after completing a business combination[20] - The company has extended the deadline to consummate a business combination from July 11, 2024, to April 11, 2025, with provisions for monthly extensions[26] - The Merger Agreement with Longevity Biomedical was terminated on June 26, 2024, and the Company is seeking alternative ways to consummate an initial business combination[39] - The Company entered into a letter of intent with Semnur for a potential business combination on July 2, 2024, although no assurance of a definitive agreement exists[123] Capital Structure and Financing - The Company completed its IPO on April 11, 2022, raising gross proceeds of $82.5 million from the sale of 8,250,000 Public Units at $10.00 each[92] - A private placement occurred simultaneously with the IPO, generating gross proceeds of $5.1 million from the sale of 510,000 Private Placement Units at $10.00 each[94] - The Company has outstanding Working Capital Loans totaling $1,128,200 as of June 30, 2024, with an accrued interest expense of $42,638[102] - The Company issued a convertible promissory note totaling up to $180,000 to Scilex, with an initial principal balance of $15,037[28] - The Company issued a FutureTech Convertible Promissory Note totaling $825,000 on July 11, 2023, and as of June 30, 2024, there was an outstanding amount of $1,275,000 under this note[46] Compliance and Regulatory Matters - The Company received a letter from Nasdaq on February 22, 2024, indicating that its Minimum Value of Listed Securities (MVLS) was below the required $50 million, with a compliance deadline of August 20, 2024[51] - On July 26, 2024, the Company regained compliance with Nasdaq Listing Rule 5450(b)(2)(A) and continues to trade on Nasdaq[52] Miscellaneous - The Company recognized no unrecognized tax benefits or accrued interest and penalties related to unrecognized tax benefits as of June 30, 2024[87] - The Company adopted ASU 2020-06 effective January 1, 2024, which simplifies accounting for convertible instruments but does not have a material impact on the financial position[91] - The Company has not experienced losses on its cash account, which may exceed the Federal Depository Insurance Coverage of $250,000[74] - The Company has agreed to registration rights for holders of founder shares and Private Placement securities, allowing them to demand registration of their securities[103]

Financial Performance - The net income for the three months ended March 31, 2024, was $264,330, compared to a net loss of $1,009,102 for the same period in 2023[10]. - Basic and diluted net income per share for redeemable ordinary shares was $0.10 for the three months ended March 31, 2024, compared to a loss of $0.07 in the same period of 2023[10]. - The net loss for the three months ended March 31, 2024, is $539,555, compared to a net loss of $1,921,748 for the same period in 2023[84]. - The Company recorded an income earned on the Trust Account of $(653,885) for the three months ended March 31, 2024[84]. Assets and Liabilities - As of March 31, 2024, the total assets of Denali Capital Acquisition Corp. amounted to $51,347,261, an increase from $50,687,403 as of December 31, 2023[8]. - Total current liabilities increased to $5,999,507 as of March 31, 2024, from $5,603,980 as of December 31, 2023[8]. - The total shareholders' deficit increased to $(8,821,595) as of March 31, 2024, from $(8,282,040) as of December 31, 2023[9]. - As of March 31, 2024, the Company had a working capital deficit of $5,934,095, with $1,013,200 outstanding under Working Capital Loans in the form of a Convertible Promissory Note issued to the Sponsor[51]. - As of March 31, 2024, the Company had marketable securities held in the Trust Account amounting to $51,281,849, intended for completing the Business Combination[48]. Business Combination Plans - The company has ongoing plans for a business combination with Longevity Biomedical, Inc., which is subject to various risks and uncertainties[6]. - The Company entered into a Merger Agreement with Longevity Biomedical, Inc., which includes the acquisition of Cerevast Medical, Aegeria Soft Tissue, and Novokera[27][29]. - Following the business combination, Holdco will become a publicly traded company, changing its name to Longevity Biomedical, Inc., and listing on Nasdaq under the ticker symbol "LBIO"[29]. - The Company extended the deadline to consummate a business combination to July 11, 2024, with shareholders having redeemed approximately $40.5 million worth of public shares[20][23]. Capital Structure and Financing - The Company raised gross proceeds of $82.5 million from the IPO of 8,250,000 units, with each unit priced at $10.00[19]. - A total of $84.15 million of net proceeds from the IPO and private placement was deposited in a trust account, invested in U.S. government securities[20]. - The Company has incurred transaction costs of $5.105 million related to the IPO, including underwriting fees and other offering costs[19]. - FutureTech agreed to purchase 625,000 Class B units of membership interests in the Sponsor for a total purchase price of $5 million, with $2 million paid as of the Merger Agreement date[32]. - The Company issued a convertible promissory note totaling $825,000 to the Sponsor, with an initial principal balance of $412,500, which may convert into Class A ordinary shares at a price of $10 per share[37]. Compliance and Risks - The Company received a notification from Nasdaq regarding non-compliance with listing requirements, specifically a Minimum Value of Listed Securities below $50 million, with a compliance deadline of August 20, 2024[57]. - The Company has evaluated conditions that raise substantial doubt about its ability to continue as a going concern through July 11, 2024, if a Business Combination is not consummated[55]. - The obligations of Longevity to consummate the Business Combination are subject to the Minimum Cash Condition of at least $30 million, which was waived on August 29, 2023[42]. Shareholder Information - The shareholders approved the Business Combination Proposal with 5,196,327 votes in favor against 10,100 votes against[44]. - As of March 31, 2024, there are 4,537,829 Class A ordinary shares subject to possible redemption, valued at $51,281,849[78]. - The Class B ordinary shares will automatically convert into Class A ordinary shares upon the consummation of the initial Business Combination at a ratio ensuring approximately 20% of the total ordinary shares[111]. Operational Challenges - The Company is at risk of not having sufficient working capital and borrowing capacity to meet its needs through the consummation of the initial Business Combination, potentially leading to operational curtailments[54]. - The Company has not had any cash equivalents as of March 31, 2024, indicating potential liquidity challenges[65]. - The Company has utilized all of the $825,000 FutureTech Convertible Promissory Note to fund required payments for extending the business combination period[52].