Revenue Performance - Total revenue for Q3 2025 was $6,461,798, a decrease of $1,049,499 or 14% compared to Q3 2024 revenue of $7,511,297[116] - Security managed services revenue decreased by $1,129,609, or 16%, for Q3 2025 compared to Q3 2024, primarily due to lower annual contract values among newly acquired customers[118] - Cybersecurity software revenue increased by $36,968, or 34%, for Q3 2025 compared to Q3 2024, driven by an increase in subscriptions for Checklight cybersecurity software[119] - Professional services revenue increased by $43,142, or 10%, for Q3 2025 compared to Q3 2024, attributed to more customer projects[118] Profit and Loss - Total gross profit for the nine months ended September 30, 2025 was $5,025,756, an increase of $2,351,557 compared to $2,674,199 for the same period in 2024[128] - Loss from operations for the nine months ended September 30, 2025 was reduced to $6,673,139, compared to $12,657,510 for the same period in 2024, reflecting an improvement of $5,984,371[128] - For the nine months ended September 30, 2025, the company incurred a net loss of $5,857,097 and reported cash used in operations of $6,180,042, with an expectation of further losses through the end of 2025[141] Cash Flow and Financing - Net cash used in operating activities for the nine months ended September 30, 2025, was $6,180,042, compared to $3,582,726 for the same period in 2024[153] - Net cash provided by financing activities for the nine months ended September 30, 2025, was $6,299,182, primarily from the sale of Common Stock and the exercise of warrants[156] - The company has $100,000,000 available from its shelf registration statement on Form S-3 to fund current and future operations, subject to certain limitations due to its public float[145] Debt and Liabilities - Total current liabilities decreased by $16,585,255 to $8,370,392 compared to $24,955,647 as of December 31, 2024[117] - As of September 30, 2025, the carrying value of outstanding debt obligations was $2,053,884, with substantial maturities scheduled for the remainder of 2025 and 2026[148] - Cumulative dividends in arrears on the Series A Preferred Stock totaled $145,200 as of September 30, 2025, with no dividends declared during the period[142] Future Outlook - The company expects to incur further losses through the end of 2025 and has substantial doubt about its ability to continue as a going concern without raising additional capital[147] - The company’s current cash on hand is insufficient to satisfy its operating cash needs for the next 12 months from the filing of the Quarterly Report[150] Other Financial Metrics - Stock-based compensation expenses decreased by $735,631, or 69%, for Q3 2025 compared to Q3 2024, due to the forfeiture of options by terminated employees[122] - Interest expense decreased by $1,110,088 for Q3 2025 compared to Q3 2024, primarily due to the extinguishment of convertible notes payable[127] - The gain on extinguishment of convertible notes increased by $5,296,103 for Q3 2025, as a result of the conversion of certain convertible notes into shares of Series A Preferred Stock[126] - The company recognized a gain on troubled debt restructuring of $5,296,103 during the three and nine months ended September 30, 2025, reflecting the difference between the carrying value of the Exchange Notes and the estimated fair value of the Series A Preferred Stock issued[143] - As of September 30, 2025, the company had a working capital deficit of $5,376,502, a significant decrease from a deficit of $21,474,576 as of December 31, 2024[151]

Financial Performance - For the three months ended September 30, 2025, net sales were $8,353,200, a decrease of 10.8% compared to $9,370,713 for the same period in 2024[13] - Gross profit for the nine months ended September 30, 2025, was $15,979,698, down 9.0% from $17,552,526 in the prior year[13] - The company reported a net loss of $1,092,450 for the three months ended September 30, 2025, compared to a net loss of $282,945 for the same period in 2024, representing a 286.5% increase in losses[13] - For the nine months ended September 30, 2025, the company reported a net loss of $1,728,636 compared to a net loss of $608,772 for the same period in 2024[18] - The company reported a loss applicable to common shareholders of $(1,655,627) for the three months ended September 30, 2025, compared to $(846,195) for the same period in 2024, representing a 95.6% increase in losses[13] - Gross profit for the three months ended September 30, 2025, was $5,003,972, down 13.9% from $5,808,114 in the prior year[36] - For the nine months ended September 30, 2025, net sales totaled $26,090,546, a decrease of 8.5% from $28,506,151 in the same period of 2024[36] - The company reported a loss per common share after preferred dividends of $(0.69) for the nine months ended September 30, 2025, compared to $(0.46) for the same period in 2024[22] Assets and Liabilities - Total current assets increased to $37,979,155 as of September 30, 2025, from $36,919,057 at December 31, 2024, reflecting a growth of 2.9%[8] - Total liabilities rose to $40,003,821 as of September 30, 2025, compared to $39,783,410 at December 31, 2024, indicating a 0.6% increase[10] - Shareholders' equity decreased to $67,594,226 as of September 30, 2025, down from $69,233,730 at December 31, 2024, a decline of 2.4%[11] - The current portion of long-term debt was $993,875 as of September 30, 2025, compared to $952,171 at December 31, 2024, reflecting a 4.4% increase[10] - The company’s long-term debt increased to $15,428,093 as of September 30, 2025, compared to $14,042,910 as of December 31, 2024[28] - The company has lease liabilities totaling $11,010,791, net of current portion, as of September 30, 2025[61] Cash Flow and Expenses - The company had a net cash from operating activities of $(1,445,702) for the nine months ended September 30, 2025, an improvement from $(2,159,828) in the same period of 2024[18] - The company paid $723,311 in interest on debt and the line of credit for the nine months ended September 30, 2025, compared to $391,962 for the same period in 2024[32] - The company paid $62,500 in income taxes for the nine months ended September 30, 2025, compared to $27,000 for the same period in 2024, indicating a significant increase[30] - The company’s depreciation expense for the nine months ended September 30, 2025, was $2,289,716, slightly down from $2,368,537 for the same period in 2024[24] - The company recognized $89,132 in stock-based compensation expense during the three months ended September 30, 2025, related to the 2025 Omnibus Equity Incentive Plan[45] Inventory and Sales - The company's total inventories increased to $34,267,179 as of September 30, 2025, up from $32,907,489 as of December 31, 2024, reflecting a rise in finished goods and work-in-process[23] - The contribution margin for the three months ended September 30, 2025, was $(105,308), compared to a positive contribution margin of $41,582 in the same period of 2024[36] - Selling expenses increased to $4,444,433 for the three months ended September 30, 2025, from $4,326,851 in the prior year, reflecting a rise of 2.7%[36] Lease Agreements - The weighted-average remaining lease term for operating leases was 14.25 years as of September 30, 2025[60] - The company has entered into long-term grape purchase agreements, but cannot calculate minimum or maximum payments due to variable factors[63] - The Company has long-term grape purchase agreements with Willamette Valley wine grape growers, but cannot determine minimum or maximum payments due to variable factors[63] - The Company extended the lease for the Peter Michael Vineyard until January 2030, with options to extend through January 2035[49] - The Company has entered into multiple leases for retail wine facilities, with terms ranging from 10 years to 34 years, and various escalation provisions tied to CPI[54][55][56][57][58][59]

Financial Performance - For the three months ended September 30, 2025, net sales decreased to $8,353,200, down 10.8% from $9,370,713 in the same period of 2024[13] - Gross profit for the nine months ended September 30, 2025, was $15,979,698, a decline of 9% compared to $17,552,526 for the same period in 2024[13] - The company reported a net loss of $1,092,450 for the three months ended September 30, 2025, compared to a net loss of $282,945 in the same period of 2024, representing an increase in loss of 286%[13] - For the nine months ended September 30, 2025, the company reported a net loss of $1,728,636 compared to a net loss of $608,772 for the same period in 2024[18] - The company reported a basic loss per share of $0.69 for the nine months ended September 30, 2025, compared to $0.46 for the same period in 2024[22] - Loss from operations for the three months ended September 30, 2025, was $(1,213,527), compared to a loss of $(136,506) in the same period of 2024[36] Assets and Liabilities - Total current assets increased to $37,979,155 as of September 30, 2025, compared to $36,919,057 at December 31, 2024, reflecting a growth of 2.86%[8] - Total liabilities rose to $40,003,821 as of September 30, 2025, compared to $39,783,410 at December 31, 2024, indicating an increase of 0.55%[10] - Shareholders' equity decreased to $67,594,226 as of September 30, 2025, down from $69,233,730 at December 31, 2024, a decline of 2.37%[11] - The company’s total assets decreased to $107,598,047 as of September 30, 2025, from $109,017,140 at December 31, 2024, a decline of 1.3%[8] - The current portion of long-term debt increased to $993,875 as of September 30, 2025, compared to $952,171 at December 31, 2024, reflecting a rise of 4.4%[10] - The company’s long-term debt increased to $15,428,093 as of September 30, 2025, compared to $14,042,910 as of December 31, 2024[28] Cash Flow and Expenses - The company had a net cash outflow from operating activities of $1,445,702 for the nine months ended September 30, 2025, an improvement from a net cash outflow of $2,159,828 in the same period of 2024[18] - The company paid $723,311 in interest on debt and the line of credit for the nine months ended September 30, 2025, compared to $391,962 for the same period in 2024[32] - Operating expenses for the three months ended September 30, 2025, totaled $6,217,499, an increase of 4.6% from $5,944,620 in the same period of 2024[13] - The company recognized $89,132 in stock-based compensation expense during the three months ended September 30, 2025, related to the 2025 Omnibus Equity Incentive Plan[45] Inventory and Assets Management - The company's total inventories increased to $34,267,179 as of September 30, 2025, up from $32,907,489 as of December 31, 2024, reflecting a rise in finished goods and work-in-process[23] - The company’s property and equipment, net, was valued at $50,098,097 as of September 30, 2025, down from $52,012,151 as of December 31, 2024[24] - The company has unamortized debt issuance costs of $163,586 as of September 30, 2025, down from $178,908 as of December 31, 2024[29] Lease Agreements - The company extended its lease for the Peter Michael Vineyard until January 2030, with options to extend through January 2035[49] - The Meadowview Vineyard lease has been extended through November 2033, with a maximum increase of 4% every three years[50] - The company entered into a new lease for a retail wine facility in Bend, Oregon, for 10 years with three five-year renewal options[59] - The weighted-average remaining lease term for operating leases was 14.25 years as of September 30, 2025, down from 15.19 years in 2024[60] - Total lease liabilities as of September 30, 2025, amounted to $11,485,723, compared to $11,354,746 at the end of 2024, showing a marginal increase of 1.15%[61] Stock and Equity - The company has received net proceeds of $3,558,807 from the issuance of Preferred Stock as of September 30, 2025[38] - The company filed a shelf Registration Statement on Form S-3 with the SEC for potential future issuance of securities, with a maximum aggregate offering amount of $20,000,000[40] - The company granted 285,000 restricted shares and share units under the 2025 Plan during the three months ended September 30, 2025[44] - The company has identified two operating segments: Direct Sales and Distributor Sales, with performance evaluated based on gross profit[33][34]

Financial Performance - Spero reported a net loss of $7.4 million for Q3 2025, a significant improvement compared to a net loss of $17.1 million in Q3 2024, resulting in a diluted net loss per share of $0.13 versus $0.32[13]. - Total revenue for Q3 2025 was $5.4 million, down from $13.5 million in Q3 2024, primarily due to decreased collaboration revenue with GSK and a decline in grant revenue[13]. - General and administrative expenses for Q3 2025 were $4.2 million, down from $5.2 million in Q3 2024, mainly due to reduced personnel-related costs[13]. - Total operating expenses for Q3 2025 were $13.4 million, compared to $32.1 million in Q3 2024, reflecting a significant reduction in costs[19]. Research and Development - Research and development expenses decreased to $8.6 million in Q3 2025 from $26.9 million in Q3 2024, attributed to reduced clinical expenses related to the PIVOT-PO trial and lower costs for the SPR720 program[13]. - Spero has discontinued the SPR720 program in Q3 2025 after reviewing data from Phase 2a and Phase 1 trials[4]. Clinical Trials - The Phase 3 PIVOT-PO trial for tebipenem HBr demonstrated a 58.5% overall success rate compared to 60.2% for intravenous imipenem-cilastatin, indicating non-inferiority[6]. - The PIVOT-PO trial was stopped early for efficacy in May 2025, highlighting the promising results of tebipenem HBr[6]. - Tebipenem HBr is being developed as an oral treatment for complicated urinary tract infections (cUTI) and could provide an alternative to IV therapies, with a potential FDA filing planned for Q4 2025[2][5]. Cash Position - As of September 30, 2025, Spero had cash and cash equivalents of $48.6 million, which is expected to fund operations into 2028[13].

Revenue and Income - Revenue for the three months ended September 30, 2025, was $5,971,467, representing a 10% increase from $5,441,142 in the same period of 2024[83] - Net other income increased by 12% to $375,655 for the three months ended September 30, 2025, compared to $335,094 in 2024[90] Expenses - Cost of services and product support decreased by 1% to $854,152 for the three months ended September 30, 2025, compared to $859,219 in 2024[85] - Sales and marketing expenses increased by 5% to $1,607,469 for the three months ended September 30, 2025, up from $1,529,100 in 2024[86] - General and administrative expenses rose by 6% to $1,372,227 for the three months ended September 30, 2025, compared to $1,292,551 in 2024[88] - Depreciation and amortization expense decreased by 13% to $243,746 for the three months ended September 30, 2025, down from $280,211 in 2024[89] - Preferred dividends decreased to $58,817 for the three months ended September 30, 2025, down 45% from $107,882 in the same period of 2024[91] Cash Flow and Liquidity - Cash and cash equivalents increased by 1% to $28,794,806 as of September 30, 2025, compared to $28,568,805 as of June 30, 2025, primarily due to higher revenue and cash receipts from customers[94][95] - Net cash provided by operating activities was $1,538,447 for the three months ended September 30, 2025, an 18% decrease from $1,868,900 in the same period of 2024[96] - Net cash used in investing activities was $(20,359) for the three months ended September 30, 2025, compared to cash provided of $34,086 in the same period of 2024, representing a 160% variance[97] - Net cash used in financing activities totaled $1,292,087 for the three months ended September 30, 2025, a 2% increase from $1,266,642 in the same period of 2024[99] - Current assets increased to $34,114,277 as of September 30, 2025, up 1% from $33,685,800 as of June 30, 2025[101] - Current liabilities decreased by 6% to $5,214,500 as of September 30, 2025, compared to $5,531,118 as of June 30, 2025[102] - The company had zero bank debt as of September 30, 2025, following the termination of its credit facility in March 2024[104][105] Dividends and Stock - The company declared a quarterly cash dividend of $0.02 per share, representing an annual yield of approximately 0.54%[76] - The quarterly cash dividend was increased by 10% to $0.01815 per share, effective for shareholders of record on December 31, 2024[105] - The company plans to redeem all Series B and B-1 Preferred Stock on or before December 2026, with $2.85 million of Preferred Stock remaining to be redeemed[91][106] Compliance and Regulatory - The compliance deadline for FSMA 204 has been extended to July 20, 2028, impacting nearly every company in the food supply chain[80] - The company focuses on recurring subscription revenue, with an emphasis on compliance, supply chain, and traceability services[84] Investments and Financial Instruments - The company’s available-for-sale debt investments include U.S. government securities, corporate debt, and mortgage-backed securities, recorded at fair value[120] - Unrealized gains and losses on available-for-sale debt investments are included in accumulated other comprehensive income (AOCI)[120] - The company assesses available-for-sale debt securities for temporary or permanent credit losses, considering factors such as fair value compared to amortized cost and changes in security ratings[121] - The company does not engage in hedging transactions to mitigate foreign currency exchange rate risks, as its operations are primarily conducted in the United States[122] - The company’s financial results are not significantly affected by foreign market conditions due to its principal operations being in the U.S.[122] Interest Rate and Lease Obligations - The effective annual percentage rate (APR) for capital leases is 4.55%, with total lease obligations depreciated on a three-year straight-line basis, costing less than $400,000[124] - The company’s exposure to interest rate changes related to borrowing is limited, and near-term changes in interest rates are not expected to materially affect financial position or cash flows[124] - Investments in fixed-rate and floating-rate instruments carry interest rate risk, potentially affecting future interest income[123] Traceability Network - The ReposiTrak Traceability Network is positioned to provide end-to-end traceability, connecting thousands of supplier locations to food wholesaler and retail locations[81] Accounting Standards - The company adopted new accounting standards effective July 1, 2019, with no material changes to revenue recognition practices compared to previous periods[117]

Revenue and Income - Revenue for the three months ended September 30, 2025, was $5,971,467, representing a 10% increase from $5,441,142 in the same period of 2024[83] - Net other income increased by 12% to $375,655 for the three months ended September 30, 2025, compared to $335,094 in 2024[90] Expenses - Cost of services and product support decreased by 1% to $854,152 for the three months ended September 30, 2025, compared to $859,219 in 2024[85] - Sales and marketing expenses increased by 5% to $1,607,469 for the three months ended September 30, 2025, up from $1,529,100 in 2024[86] - General and administrative expenses rose by 6% to $1,372,227 for the three months ended September 30, 2025, compared to $1,292,551 in 2024[88] - Depreciation and amortization expense decreased by 13% to $243,746 for the three months ended September 30, 2025, down from $280,211 in 2024[89] Cash Flow and Investments - Net cash provided by operating activities was $1,538,447 for the three months ended September 30, 2025, an 18% decrease from $1,868,900 in the same period of 2024[96] - Net cash used in investing activities was $(20,359) for the three months ended September 30, 2025, compared to cash provided of $34,086 in the same period of 2024, reflecting a 160% variance[97] - Net cash used in financing activities totaled $1,292,087 for the three months ended September 30, 2025, a 2% increase from $1,266,642 in the same period of 2024, due to increased stock buybacks and continued redemption of Preferred Stock[99] Assets and Liabilities - Cash and cash equivalents increased by 1% to $28,794,806 as of September 30, 2025, compared to $28,568,805 as of June 30, 2025, primarily due to higher revenue and cash receipts from customers[94][95] - Current assets increased to $34,114,277 as of September 30, 2025, up 1% from $33,685,800 as of June 30, 2025[101] - Current liabilities decreased by 6% to $5,214,500 as of September 30, 2025, compared to $5,531,118 as of June 30, 2025[102] Dividends and Stock - The company declared a quarterly cash dividend of $0.02 per share, representing an annual dividend yield of approximately 0.54%[76] - The Company declared a quarterly cash dividend of $0.01 per share for the quarter ending September 30, 2025, representing a 10% increase from the previous dividend[105] - A total of 571,772 shares of Preferred Stock have been redeemed at a total cost of $6,117,960, with $2.85 million of Preferred Stock remaining to be redeemed[106] - Preferred dividends decreased to $58,817 for the three months ended September 30, 2025, down 45% from $107,882 in the same period of 2024[91] Company Strategy and Operations - The company’s growth in traceability services is driven by increased regulatory requirements and consumer response to food safety hazards[83] - The company is focusing on recurring subscription revenue, with less emphasis on transactional revenue[84] - The ReposiTrak Traceability Network is positioned to provide end-to-end traceability, connecting thousands of suppliers and retailers[81] Financial Position and Accounting - The Company had zero bank debt as of September 30, 2025, following the termination of its credit facility in March 2024[104] - The company adopted new accounting standards effective July 1, 2019, with no material changes to revenue recognition practices compared to previous periods[117] - The effective annual percentage rate (APR) for capital leases is 4.55%, with total lease obligations depreciated on a three-year straight-line basis, costing less than $400,000[124] - As of September 30, 2025, the fair value of cash holdings is $28,794,806, with a weighted average interest rate of 4.71%[125] - The company does not engage in hedging transactions to mitigate foreign currency exchange rate risks, as its operations are primarily in the United States[122] - Interest rate changes are not expected to materially affect the company's financial position or cash flows, given the composition of its cash in bank deposits and short-term money market instruments[123] - The company assesses available-for-sale debt securities for credit loss, considering factors such as fair value relative to amortized cost and changes in security ratings[121] - Unrealized gains and losses on available-for-sale debt investments are recorded in accumulated other comprehensive income (AOCI)[120] - The company classifies its investments as current based on their nature and availability for use in operations[120] - The company measures stock-based compensation at grant date fair value, recognizing it as an expense over the requisite service period[118] - The company has updated all amounts and disclosures in its financial reports to comply with the new lease accounting standard[119]

Project Development - Stardust Power is developing a large-scale lithium refinery in Oklahoma to manufacture battery-grade lithium carbonate for the EV and ESS markets [165]. - The FEL-3 report estimates Phase 1 production capacity at 25,000 metric tons per annum of battery-grade lithium, with capital expenditures of approximately $500 million [179]. - The Company is in the development stage, having completed various site assessments and submitted necessary permit applications for its planned refinery [193][194]. - The estimated cost to build phase 1 of the refinery for battery grade lithium carbonate is approximately $500 million, with plans to finance through a mix of debt, equity, and potential government grants [240]. Financial Incentives and Agreements - The company received up to $257 million in performance-based incentives from the State of Oklahoma, contingent on job creation and capital expenditures [168]. - A long-term offtake agreement with Sumitomo Corporation is contemplated for 20,000 metric tons of lithium carbonate per year, with a potential increase to 25,000 metric tons [182]. - A non-binding agreement with Prairie Lithium Limited for 6,000 metric tons per annum of lithium chloride was established, with a 6-year initial term [176]. - The company has plans to source lithium chloride feedstock from various suppliers and may invest upstream to secure additional feedstock [166]. Financing and Capital Structure - The company raised approximately $5,750,000 from a public offering of 479,200 shares at $12.00 per share on January 27, 2025 [172]. - The Company entered into a loan agreement totaling $1,750,000 with a 15% annual interest rate, maturing in March 2025, and pledged 550,000 shares as collateral [185]. - An additional loan agreement was established for $1,800,000, also at a 15% interest rate, with 340,000 shares pledged as collateral, and an equity kicker of $2,700,000 in Common Stock [186]. - The company has fully repaid short-term loans totaling $1,750,000 and $1,800,000, which were secured against shares of common stock owned by the CEO [253][255]. - The company may seek additional equity or debt financing to fund its operating and investing activities in the future [262]. Operational Performance - The Company has not generated any revenue to date and has been operating at a loss since inception, with an accumulated deficit [200]. - For the three months ended September 30, 2025, the company incurred a net loss of $4,459,764, compared to a net loss of $10,092,312 for the same period in 2024, indicating a 56% improvement year-over-year [238]. - The accumulated deficit as of September 30, 2025, was $64,592,850, up from $52,618,948 as of December 31, 2024, reflecting ongoing operational losses since inception [239]. - The company has not earned any revenue and has been operating at a loss since inception, raising substantial doubt about its ability to continue operations over the next twelve months [262]. Expenses and Cash Flow - General and administrative expenses are anticipated to increase as the Company invests in setting up its facility and hiring additional employees [207]. - The net cash used in operating activities for the nine months ended September 30, 2025, was $6,548,760, a decrease of $1,965,401 compared to $8,514,161 for the same period in 2024 [256]. - For the nine months ended September 30, 2025, net cash used in investing activities was $3,001,632, primarily for capital project costs related to the construction of the refinery [258]. - For the nine months ended September 30, 2025, net cash provided by financing activities was $10,222,822, mainly from public offerings gross proceeds of $10,270,400 [260]. Market and Compliance Issues - The Company received a notice from Nasdaq regarding non-compliance with listing standards due to a market value below $15,000,000, but regained compliance by September 2025 [187]. - The Company also faced a minimum bid price notice for shares closing below $1.00, which was resolved by September 2025 [188]. - A reverse stock split of 1-for-10 was executed on September 8, 2025, approved by stockholders, affecting outstanding shares and warrants [190][191]. Investment and Losses - Stardust Power invested $1,600,000 in 10,000,000 shares of IRIS Metals Limited, later selling the investment for $570,255, resulting in a loss of $84,626 [180]. - The loss on sale of investments in equity securities was $84,626 for the three months and $179,805 for the nine months ended September 30, 2025 [235]. - The company recorded a loss of $232,481 related to the write-off of a promissory note and deposit for the nine months ended September 30, 2025 [236]. Risk Factors - The Company is subject to credit risk for cash balances exceeding the FDIC insured amount of $250,000, with only one financial banking institution [293]. - The Company is currently operating in a volatile inflationary environment, which could impact its financial condition and results of operations [294]. - The company anticipates that cash on hand and additional investments will be inadequate to satisfy working capital and capital expenditure requirements for at least the next twelve months [243].

Project Development - Stardust Power is developing a large-scale lithium refinery in Oklahoma to manufacture battery-grade lithium carbonate for the EV and ESS markets [165]. - The FEL-3 report estimates Phase 1 production capacity at 25,000 metric tons per annum of battery-grade lithium, with capital expenditures of approximately $500 million [179]. - The Company is developing a refinery with a phased approach, aiming for a total capacity of up to 50,000 metric tons per annum [195]. - The estimated cost to build phase 1 of the refinery for battery grade lithium carbonate is approximately $500 million, with plans to finance through a mix of debt, equity, and potential government grants [240]. Financial Incentives and Agreements - The company received up to $257 million in performance-based incentives from the State of Oklahoma, contingent on job creation and capital expenditures [168]. - A long-term offtake agreement with Sumitomo Corporation is being contemplated for 20,000 metric tons of lithium carbonate per year, with a potential increase to 25,000 metric tons [182]. - A non-binding agreement with Prairie Lithium Limited for 6,000 metric tons per annum of lithium chloride was established, with a 6-year initial term [176]. - The company entered into a purchase agreement for land in Muskogee, Oklahoma, for $1,662,030, finalized on December 16, 2024 [170]. Financing and Capital Structure - The company raised approximately $5,750,000 from a public offering of 479,200 shares at $12.00 per share on January 27, 2025 [172]. - The Company entered into a loan agreement totaling $1,750,000 with a 15% annual interest rate, maturing in March 2025, and pledged 550,000 shares as collateral [185]. - An additional loan agreement was established for $1,800,000, also at a 15% interest rate, with 340,000 shares pledged as collateral, and an equity kicker of $2,700,000 in Common Stock [186]. - The company has funded operations through various financing methods, including equity financing and promissory notes, but anticipates needing additional capital to continue operations [241]. Operational Performance - The Company has not generated any revenue to date and has been operating at a loss since inception, with an accumulated deficit [200]. - The Company expects to generate future revenue from the sale of battery-grade lithium primarily to the EV market, entering long-term contracts with a pricing structure that includes caps and ceilings [205]. - The company has not sourced any raw materials yet and is negotiating with multiple suppliers for brine feedstock [206]. - General and administrative expenses are expected to increase as the Company invests in setting up its facility and hiring additional employees [207]. Financial Results - For the three months ended September 30, 2025, the company incurred a net loss of $4,459,764, compared to a net loss of $10,092,312 for the same period in 2024, indicating a reduction in losses by approximately 56% [238]. - As of September 30, 2025, the company had an accumulated deficit of $64,592,850, up from $52,618,948 as of December 31, 2024 [239]. - The company has not earned any revenue since inception, indicating a focus on strategic investments and operational development [223]. - For the nine months ended September 30, 2025, net cash used in operating activities was $6,548,760, with a net loss of $11,973,902 adjusted for $5,247,665 of non-cash charges [257]. Compliance and Regulatory Issues - The Company received a notice from Nasdaq regarding non-compliance with listing standards due to a market value below $15,000,000, but regained compliance by September 2025 [187]. - The Company was also notified of non-compliance due to a minimum bid price below $1.00 per share, which was resolved by September 2025 [188]. - A reverse stock split of 1-for-10 was executed, effective September 8, 2025, to adjust the trading price of Common Stock [190]. Investment and Losses - Stardust Power invested $1,600,000 in IRIS Metals Limited, acquiring 10,000,000 shares, but later sold the investment for $570,255, recognizing a loss of $84,626 [180]. - The loss on sale of investments in equity securities was $84,626 for the three months and $179,805 for the nine months ended September 30, 2025, reflecting market conditions and liquidity needs [235]. - The company recorded a loss of $232,481 related to the write-off of a promissory note and deposit for the nine months ended September 30, 2025, with no such write-off in the prior year [236]. Future Outlook and Risks - The company may need to seek additional equity or debt financing to fund its operating and investing activities in the future [262]. - The company is currently facing a volatile inflationary environment, which could impact its business and financial condition [294]. - The Company is subject to credit risk for cash balances exceeding the FDIC insured amount of $250,000, with only one financial banking institution [293].

Drug Development and Clinical Trials - Gedatolisib is a pan-class I isoform PI3K inhibitor with low nanomolar potency for p110α, p110β, p110γ, and p110δ isoforms, and mTORC1 and mTORC2 complexes, providing comprehensive inhibition of the PAM pathway[93]. - In the Phase 1b clinical trial, the overall response rate (ORR) for treatment-naïve patients with advanced breast cancer was 85%, while the ORR for patients who received prior hormonal therapy ranged from 36% to 77%[99]. - The median progression-free survival (PFS) for treatment-naïve patients receiving gedatolisib combined with palbociclib plus letrozole was 48.6 months[100]. - As of September 30, 2025, 492 patients with solid tumors have received gedatolisib across eight completed clinical trials[97]. - The VIKTORIA-1 Phase 3 trial has completed enrollment of 351 subjects for the PIK3CA wild-type cohort, with primary completion achieved in May 2025[108]. - The Phase 3 trial VIKTORIA-2 is currently enrolling patients, evaluating gedatolisib in combination with a CDK 4/6 inhibitor and fulvestrant for advanced breast cancer[91]. - The median PFS for patients with PIK3CA mutant tumors was 14.6 months, with an ORR of 48%[104]. - Topline data for the PIK3CA mutant cohort of the VIKTORIA-1 trial is expected to be available in late Q1 2026 or Q2 2026[108]. - The gedatolisib triplet demonstrated a median progression-free survival (PFS) of 9.3 months, an improvement of 7.3 months over fulvestrant, with a hazard ratio (HR) of 0.24, indicating a 76% reduction in the risk of disease progression or death[109]. - The gedatolisib doublet showed a median PFS of 7.4 months, an improvement of 5.4 months over fulvestrant, with a HR of 0.33, indicating a 67% reduction in the risk of disease progression or death[109]. - The overall response rate (ORR) for the gedatolisib triplet was 31.5%, with a median duration of response (DOR) of 17.5 months, while the ORR for the gedatolisib doublet was 28.3% with a median DOR of 12.0 months[109]. - The CELC-G-201 Phase 1b trial reported a six-month radiographic progression-free survival (rPFS) rate of 67% and a median rPFS of 9.1 months across both treatment arms[118]. Financial Performance and Expenses - The company reported a net loss of approximately $43.8 million for the three months ended September 30, 2025, compared to a net loss of $29.8 million for the same period in 2024[128]. - As of September 30, 2025, the company had an accumulated deficit of approximately $397.9 million and cash and cash equivalents of approximately $455.0 million[128]. - Research and development expenses for Q3 2025 were approximately $34.9 million, an increase of 27% compared to Q3 2024[140]. - General and administrative expenses for Q3 2025 were approximately $7.9 million, reflecting a significant increase of 221% compared to Q3 2024[143]. - Total operating expenses for Q3 2025 reached $42.8 million, a 43% increase from $30.1 million in Q3 2024[137]. - Research and development expenses for the nine months ended September 30, 2025, were approximately $107.4 million, a 52% increase from $70.7 million in the same period of 2024[141]. - Total operating expenses for the nine months ended September 30, 2025, were $123.0 million, a 60% increase compared to $76.8 million in the same period of 2024[139]. - Interest expense for Q3 2025 was $4.6 million, a 37% increase compared to $3.3 million in Q3 2024[146]. Capital and Funding Activities - The company completed an equity offering of 1,836,842 shares at $38.00 per share, raising approximately $69.7 million[123]. - The company raised approximately $481.7 million through equity securities and $194.9 million through the issuance of convertible notes since inception[150]. - The company completed an equity offering in July 2025, generating approximately $91.6 million in net proceeds for working capital and general corporate purposes[152]. - The company received net proceeds of approximately $27.8 million from the disbursement of the $30.0 million Term D Loan[166]. - The company achieved the Term D Milestone, allowing for the draw of an additional $30.0 million of indebtedness under the Term D Loan[171]. - The company is entitled to make interest-only payments for up to 48 months under the A&R Loan Agreement, with interest rates starting at 7.75% plus 2.85%[175]. - The company recognized a Final Fee of $4.5 million as additional debt principal, which will be amortized over the life of the loan[176]. Future Outlook and Risks - The company expects research and development expenses to increase as it continues to develop gedatolisib and conduct multiple clinical trials[179]. - The company believes its current cash and available borrowings will be sufficient to finance operations through 2027[180]. - The company may seek to raise additional capital through equity or convertible debt securities, which could result in dilution to stockholders[181]. - The company is facing known and unknown risks that may cause actual results to differ materially from forward-looking statements[196]. - There are uncertainties and costs associated with the development and commercialization of gedatolisib, which may impact timely regulatory approval[196]. - The company may encounter challenges in maintaining relationships with pharmaceutical partners and suppliers[196]. - Market acceptance by physicians, patients, and payors remains uncertain, affecting potential market opportunities[196]. - The company is subject to risks related to hiring and retaining qualified personnel, which could impact growth management[196]. - Changes in government regulations and tightening credit markets may affect capital access[196]. - The company has no obligation to update forward-looking statements unless required by law[197]. - As a smaller reporting company, the company is not required to provide specific market risk disclosures[198].

Clinical Development - NGN-401 for Rett syndrome demonstrated promising interim clinical data, with the first participant dosed in Q4 2025 and enrollment expected to complete in 3-6 months[8] - The Embolden™ registrational trial for NGN-401 is a single-arm, open-label study with a sample size of 20 females, requiring a 35% response rate (7 out of 20 participants) for success[28] - The primary endpoint of the Embolden trial is a responder-based composite endpoint, with key secondary endpoints focusing on developmental milestones[28] - The trial design includes immunosuppression with corticosteroids for 91 days, followed by a taper, to enhance treatment efficacy[29] - 12 of 13 clinical trial sites for the Embolden trial have been initiated, with enrollment expected to complete in 3-6 months[44] - The first participant has been dosed in the Embolden trial, marking a significant milestone in the clinical development of NGN-401[44] - The trial design for ages over 3 is expected to enable the most efficient path to market for NGN-401[44] - Completion of Embolden registrational trial enrollment is anticipated within 3-6 months as of November 2025[90] Market Need - The U.S. prevalence of Rett syndrome is estimated to be between 6,000 and 9,000 patients, with a worldwide incidence of 1 in 10,000 females, indicating a significant unmet need for new treatment options[21] - Caregivers of Rett syndrome patients indicated that any skill gain or symptom improvement would provide significant respite and independence for their daughters[93] Efficacy and Safety - NGN-401 demonstrates significant skill gains, with 35 total skills acquired across participants, showing durability and no skills lost over time[46] - Early efficacy observed at 6 months post-treatment shows 3 of 3 participants with functional gains and a CGI-I of ≤ 3[54] - Participants have reported improvements in key domains, including communication, gross motor function, and fine motor skills, leading to enhanced quality of life[83] - NGN-401 remains generally well tolerated at the 1E15 vg dose level, with 9 out of 10 participants experiencing treatment-emergent adverse events[86] - All treatment emergent adverse events (TEAEs) related to NGN-401 have been Grade 1 (mild) or Grade 2 (moderate) in severity, with most participants experiencing mild liver enzyme elevations[87] - No evidence of hemophagocytic lymphohistiocytosis (HLH) in any participant, and seizures have remained well controlled following NGN-401 treatment[87] - NGN-401 demonstrated efficacy and safety in Mecp2 mouse models, showing targeted MeCP2 levels through ICV delivery[94] Technology and Manufacturing - The EXACT™ transgene regulation technology used in NGN-401 aims to deliver consistent and tightly controlled MeCP2 protein expression, addressing a key limitation in gene therapy[25] - The use of EXACT™ Technology in NGN-401 aims to limit expression and ensure safe delivery of therapy[46] - The EXACT platform delivers consistent levels of MECP2 expression on a cell-by-cell basis, indicating potential for precise therapeutic applications[97] - Neurogene's internal manufacturing capabilities are designed for commercial-grade products, with a facility of 42,000 sq ft in Houston, including 6,000 sq ft of cleanrooms[12] - Neurogene's manufacturing process allows for low-cost production and control over product quality and development timelines[16] Financial Outlook - Cash runway is expected to fund operations through Q1 2028, providing strategic flexibility for ongoing and future projects[8] - Cash runway is expected to fund operations through 1Q'28, ensuring financial stability for ongoing projects[90] - The company plans to provide a regulatory update in 1H:25 regarding the Embolden™ registrational trial and initiate trial activities[90] - The clinical trial footprint is expected to more than double in the U.S., with dosing in the Embolden registrational trial to be initiated soon[90] - The company aims to announce additional Phase 1/2 clinical data in 2H:25 and 2026, reflecting ongoing commitment to research and development[90] Pipeline Expansion - The company is evaluating opportunities for NGN-101 targeting CLN5 Batten Disease, expanding its pipeline of genetic medicines[9]