季報
季度報告
10-Q
2026-05-14
Cingulate Inc.首季净亏损扩至931万美元 现金改善至2589万美元
AI 繁中摘要
Cingulate Inc. (CING) 呈交 10-Q 季度報告，截至 2026 年 3 月 31 日止第一季。
業績重點：公司仍處於營運前階段，無任何收入。第一季淨虧損擴大至 931.2 萬美元（每股 0.95 美元），對比去年同期虧損 385.3 萬美元（每股 1.06 美元）。營運虧損由 370.6 萬美元增至 792.3 萬美元，主要由於一般及行政開支大幅上升至 573.9 萬美元（去年同期 148.3 萬美元），當中包括 352.5 萬美元的商業化前期成本，為潛在產品上市做準備。研發開支則輕微下跌至 218.4 萬美元。
現金狀況顯著改善：截至 2026 年 3 月 31 日，現金及現金等價物約 2,589 萬美元，較 2025 年底的 1,095 萬美元大幅增加。季內營運活動現金流出 691.3 萬美元，但融資活動提供 2,191.4 萬美元淨流入，主要來自多項集資活動。
融資活動摘要：1 月完成私募，發行約 214.7 萬股普通股、954 股 A 系列可轉換優先股（已於 3 月轉換）及認股權證，籌得約 1,200 萬美元。此外，透過與 Lincoln Park 的購買協議及 ATM 發行籌集約 1,014 萬美元；另與 Streeterville Capital 進行債務交換，發行 46 萬股以清償部分可換股票據。
研發進展：核心資產 CTx-1301（用於 ADHD）的新藥申請已於 2025 年 7 月提交 FDA，並獲接納，PDUFA 目標日期為 2026 年 5 月 31 日。若未能如期獲批或遭拒絕，將對公司構成重大打擊。
管理層展望與風險：管理層指出公司自成立以來持續錄得虧損及負現金流，雖然目前資金足以支撐短期營運，但未來仍需額外資金。報告內明確提出對持續經營能力存在重大疑慮。公司能否繼續營運很大程度上取決於 CTx-1301 能否獲 FDA 批准，以及能否進一步獲得融資。
對投資者的潛在影響：PDUFA
展開英文正文
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ended March 31, 2026 or ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from________ to_________. Commission File Number: 001-40874 Cingulate Inc. (Exact name of registrant as specified in its charter) Delaware 86-3825535 (State or other jurisdiction of incorporation or organization) (I.R.S. Employer Identification No.) 1901 W. 47th Place Kansas City, KS 66205 (Address of principal executive offices) (Zip Code) (913) 942-2300 (Registrant’s telephone number, including area code) Securities registered pursuant to Section 12(b) of the Act: Title of each class Trading Symbol(s) Name of exchange on which registered Common Stock, par value $0.0001 per share CING The Nasdaq Stock Market LLC (Nasdaq Capital Market) Warrants, exercisable for shares of common stock CINGW The Nasdaq Stock Market LLC (Nasdaq Capital Market) Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days. Yes ☒ No ☐ Indicate by check mark whether the registrant has submitted electronically every Interactive Data File required to be submitted and posted pursuant to Rule 405 of Regulation S-T (§232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit such files). Yes ☒ No ☐ Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, a smaller reporting company, or an emerging growth company. See the definitions of “large accelerated filer,” “accelerated filer,” “smaller reporting company,” and “emerging growth company” in Rule 12b-2 of the Exchange Act. Large accelerated filer ☐ Accelerated filer ☐ Non-accelerated filer ☒ Smaller reporting company ☒ Emerging growth company ☒ If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐ Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act). Yes ☐ No ☒ As of May 12, 2026, 13,276,022 shares of the registrant’s common stock, $0.0001 par value, were issued and outstanding. Cingulate Inc. Form 10-Q for the Quarter Ended March 31, 2026 TABLE OF CONTENTS Page PART I Item 1 Financial Statements 4 Item 2 Management’s Discussion and Analysis of Financial Condition and Results of Operations 22 Item 3 Quantitative and Qualitative Disclosures About Market Risk 33 Item 4 Controls and Procedures 33 PART II Item 1 Legal Proceedings 33 Item 1A Risk Factors 33 Item 2 Unregistered Sales of Equity Securities and Use of Proceeds 34 Item 5 Other Information 34 Item 6 Exhibits 34 Signatures 35 2 CAUTIONARY NOTE REGARDING FORWARD LOOKING STATEMENTS This report contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended, that involve substantial risks and uncertainties. In some cases, you can identify forward-looking statements by terms such as “may,” “will,” “should,” “expect,” “plan,” “anticipate,” “could,” “intend,” “target,” “project,”, “believe,” “estimate,” “predict,” “potential” or “continue” or the negative of these terms or other similar expressions intended to identify statements about the future. These statements speak only as of the date of filing this report with the Securities and Exchange Commission (SEC) and involve known and unknown risks, uncertainties and other important factors that may cause our actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements. We have based these forward-looking statements largely on our current expectations and projections about future events and financial trends that we believe may affect our business, financial condition and results of operations. These forward-looking statements include, without limitation, statements about the following: ● our ability to maintain compliance with the continued listing requirements of The Nasdaq Stock Market LLC (Nasdaq); ● our ability to obtain approval for CTx-1301 and the timing of any such approval; ● our lack of operating history and need for additional capital; ● our plans to develop and commercialize our product candidates; ● the timing of our planned clinical trials for our product candidates; ● the timing of our New Drug Application (NDA) submissions for our product candidates; ● the timing of and our ability to obtain and maintain regulatory approvals for our product candidates; ● the clinical utility of our product candidates; ● our commercialization, marketing and manufacturing capabilities and strategy; ● our ability to identify strategic partnerships; ● our expected use of cash; ● our competitive position and projections relating to our competitors or our industry; ● our ability to identify, recruit, and retain key personnel; ● the impact of laws and regulations; ● our expectations regarding the time during which we will be an emerging growth company under the Jumpstart Our Business Startups Act of 2012 (JOBS Act); ● our plans to identify additional product candidates with significant commercial potential that are consistent with our commercial objectives; and ● our estimates regarding future revenue and expenses. Because forward-looking statements are inherently subject to risks and uncertainties, some of which cannot be predicted or quantified and some of which are beyond our control, you should not rely on these forward-looking statements as predictions of future events. The events and circumstances reflected in our forward-looking statements may not be achieved or occur and actual results could differ materially from those projected in the forward-looking statements. You should refer to the “Risk Factors” section in our Annual Report on Form 10-K for the fiscal year ended December 31, 2025, filed with the SEC on March 18, 2026 (Form 10-K), for a discussion of important factors that may cause our actual results to differ materially from those expressed or implied by our forward-looking statements. We operate in an evolving environment and new risk factors and uncertainties may emerge from time to time. It is not possible for management to predict all risk factors and uncertainties. As a result of these factors, we cannot assure you that the forward-looking statements in this report will prove to be accurate. Except as required by applicable law, we do not plan to publicly update or revise any forward-looking statements contained herein, whether as a result of any new information, future events, changed circumstances or otherwise. You should review the factors and risks and other information we describe in the reports we will file from time to time with the SEC. 3 PART I — FINANCIAL INFORMATION Cingulate Inc. Consolidated Balance Sheets (unaudited) March 31, December 31, 2026 2025 ASSETS Current assets: Cash and cash equivalents $25,893,210 $10,953,383 Other receivables 53,938 8,013 Prepaid expenses and other current assets 1,966,348 1,046,862 Total current assets 27,913,496 12,008,258 Property and equipment, net 1,665,917 1,725,919 Operating lease right-of-use assets 1,282,288 1,339,086 Total assets 30,861,701 15,073,263 LIABILITIES AND STOCKHOLDERS’ EQUITY Current liabilities: Accounts payable 2,670,137 2,035,685 Accrued expenses 1,897,707 1,742,116 Note payable, current 6,146,703 6,295,960 Operating lease liability, current 246,864 238,864 Total current liabilities 10,961,411 10,312,625 Long-term liabilities: Operating lease liability, net of current 1,035,424 1,100,222 Note payable - 1,151,509 Total long-term liabilities 1,035,424 2,251,731 Total liabilities 11,996,835 12,564,356 Stockholders’ Equity Common Stock, $0.0001 par value; 240,000,000 shares authorized and 11,908,316 and 7,250,299 shares issued and outstanding as of March 31, 2026 and December 31, 2025 1,190 725 Preferred Stock, $0.0001 par value; 10,000,000 shares authorized and 0 shares issued and outstanding as of March 31, 2026 and December 31, 2025 - - Additional Paid-in-Capital 160,550,796 134,883,213 Accumulated deficit (141,687,120) (132,375,031) Total stockholders’ equity 18,864,866 2,508,907 Total liabilities and stockholders’ equity $30,861,701 $15,073,263 See notes to unaudited consolidated financial statements. 4 Cingulate Inc. Consolidated Statements of Operations and Comprehensive Loss (unaudited) 2026 2025 Three Months Ended March 31, 2026 2025 Operating expenses: Research and development $2,184,318 $2,222,626 General and administrative 5,738,904 1,483,409 Operating loss (7,923,222) (3,706,035) Change in fair value of derivative (852,030) (49,987) Interest and other income (expense), net (536,837) (96,656) Loss before income taxes (9,312,089) (3,852,678) Income tax benefit (expense) - - Net loss and comprehensive loss $(9,312,089) $(3,852,678) Net loss per share of common stock, basic and diluted $(0.95) $(1.06) Weighted average number of shares used in computing net loss per share of common stock, basic and diluted 9,777,786 3,646,893 See notes to unaudited consolidated financial statements. 5 Cingulate Inc. Consolidated Statements of Stockholders’ Equity (unaudited) Shares Amount Shares Amount Paid-in-Capital Deficit Income Equity Accumulated Common Stock Preferred Stock Additional Accumulated Other Comprehensive Stockholders’ Shares Amount Shares Amount Paid-in-Capital Deficit Income Equity Balance January 1, 2025 3,402,306 340 - - $117,380,285 $(109,925,120) $ - $7,455,505 Activity for the three months to March 31, 2025: Issuance of common stock in connection with At the Market Offering and Purchase Agreement, net of fees 423,893 42 - - 1,920,315 - - 1,920,357 Change in fair value of derivative - - - - 49,987 - - 49,987 Stock-based compensation expense - - - - 357,649 - - 357,649 Net loss - - - - - (3,852,678) - (3,852,678) Balance March 31, 2025 3,826,199 $382 - $- $119,708,236 $(113,777,798) $- $5,930,820 Balance January 1, 2026 7,250,299 $725 - $- $134,883,213 $(132,375,031) $- $2,508,907 Activity for the three months to March 31, 2026: Issuance of common stock in connection with At the Market Offering and Purchase Agreement, net of fees 1,824,664 182 - - 10,143,153 - - 10,143,335 Issuance of common stock relating to Streeterville Promissory Note 460,122 46 - - 2,308,901 - - 2,308,947 Issuance of common stock in connection with Private Placement 2,147,472 215 - - 10,816,421 - - 10,816,636 Issuance of preferred stock in connection with Private Placement - - 954 - 954,000 - - 954,000 Preferred stock to common stock conversion 189,300 19 (954) - (19) - - - Preferred stock dividend 2,524 - - - - - - - Change in fair value of derivative - - - - 852,030 - - 852,030 Stock-based compensation expense, net of taxes 33,935 3 - - 593,097 - - 593,100 Net loss - - - - - (9,312,089) - (9,312,089) Balance March 31, 2026 11,908,316 $1,190 - $- $160,550,796 $(141,687,120) $- $18,864,866 See notes to unaudited consolidated financial statements. 6 Cingulate Inc. Consolidated Statements of Cash Flows (unaudited) 2026 2025 Three Months Ended March 31, 2026 2025 Operating activities: Net loss $(9,312,089) $(3,852,678) Adjustments to reconcile net loss to net cash used in operating activities: Adjustments to reconcile net loss to net cash used in operating activities: Depreciation 121,185 165,291 Stock-based compensation 593,100 357,649 Accretion of discount on note payable 151,200 7,670 Amortization of debt issue costs 5,562 76,976 Loss on debt extinguishment 336,781 - Change in fair value of derivative 852,030 49,987 Changes in operating assets and liabilities: Other receivables (45,925) (15,248) Prepaid expenses and other current assets (919,486) (521,276) Operating lease right-of-use assets 56,798 73,779 Trade accounts payable and accrued expenses 1,304,682 (852,914) Current portion of operating lease liability 8,000 (97,518) Long-term portion of operating lease liability (64,798) - Net cash used in operating activities (6,912,960) (4,608,282) Investing activities: Purchase of property and equipment (61,183) - Net cash used in investing activities (61,183) - Financing activities: Proceeds from the issuance of common stock and common stock purchase warrants, net of fees 21,913,970 1,920,357 Principal payments on finance lease obligations - (4,430) Net cash provided by financing activities 21,913,970 1,915,927 Cash and cash equivalents: Net increase (decrease) in cash and cash equivalents 14,939,827 (2,692,355) Cash and cash equivalents at beginning of year 10,953,383 12,211,321 Cash and cash equivalents at end of period $25,893,210 $9,518,966 Cash paid for interest $803 $45 See notes to unaudited consolidated financial statements. 7 CINGULATE INC. Notes to Consolidated Financial Statements (1) Nature of the Business and Liquidity Organization Cingulate Inc. (Cingulate, or the Company), a Delaware corporation, is a biopharmaceutical company focused on the development of products utilizing its drug delivery platform technology that enables the formulation and manufacture of once-daily tablets of multi-dose therapies, with an initial focus on the treatment of Attention Deficit/Hyperactivity Disorder (ADHD). The Company is developing two proprietary, first-line stimulant medications, CTx-1301 (dexmethylphenidate) and CTx-1302 (dextroamphetamine), for the treatment of ADHD intended for all patient segments: children, adolescents, and adults. CTx-1301 and CTx-1302 utilize a flexible core tableting technology with target product profile designed to deliver a rapid onset and last the entire active day with a controlled descent of plasma drug level and have favorable tolerability. CTx1301 is in late-stage development, and we plan to initiate the clinical plan for CTx-1302 pending additional capital resources. In addition, the Company has a third product to treat anxiety, CTx-2103, in a formulation stage. The Company submitted its New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) on July 31, 2025 for lead asset CTx-1301 and received confirmation of acceptance of the NDA in early October 2025 with a Prescription Drug User Fee Act (PDUFA) target action date of May 31, 2026. A failure to receive FDA approval for CTx-1301, or a delay in receiving such approval, will likely have a material adverse impact on the Company’s financial results and strategic position, as outlined in Item 1A. Risk Factors of our Annual Report on Form 10-K for the year ended December 31, 2025. The consolidated financial statements and notes for the periods ended March 31, 2026 and 2025, represent the full consolidation of Cingulate and its subsidiaries, including Cingulate Therapeutics LLC (CTx) and all references to the Company represent this full consolidation. Liquidity The Company has incurred losses and negative cash flows from operations since inception. As a pre-revenue entity, the Company is dependent on the ability to raise capital to support operations until such time as the product candidates under development are U.S. Food and Drug Administration (FDA) approved, manufactured, commercially available to the marketplace and produce revenues. On March 31, 2026, the Company had cash and cash equivalents of approximately $25.9 million, and an accumulated deficit of approximately $141.7 million. However, the Company will need additional funding for operations and development. Management is evaluating various strategies to obtain additional funding, which may include additional offerings of equity, issuance of debt, or other capital sources, including potential collaborations with other companies or other strategic transactions. Successful implementation of these plans involves both the Company’s efforts and factors that are outside its control, such as market factors and FDA approval of product candidates. The Company can give no assurance that its plans will be effectively implemented in such a way that they will sufficiently alleviate or mitigate the conditions and events noted above, which results in substantial doubt about the Company’s ability to continue as a going concern within one year after the date that the financial statements are issued. The accompanying consolidated financial statements have been prepared on a going concern basis, which contemplates the realization of assets and satisfaction of liabilities in the normal course of business. The consolidated financial statements do not reflect any adjustments that might result from the outcome of this uncertainty. (2) Summary of Significant Accounting Policies (a) Basis of Presentation and Principles of Consolidation The accompanying consolidated financial statements have been prepared in accordance with U.S. generally accepted accounting principles (U.S. GAAP). The consolidated financial statements include the accounts of Cingulate and its wholly-owned subsidiaries. All intercompany accounts and transactions have been eliminated in consolidation. 8 (b) Unaudited Interim Financial Information The accompanying consolidated balance sheets as of March 31, 2026 and December 31, 2025, the consolidated statements of operations and comprehensive loss for the three-month periods ended March 31, 2026 and 2025, the consolidated statements of stockholders’ equity for the three-month periods ended March 31, 2026 and 2025, the consolidated statements of cash flows for the three-month periods ended March 31, 2026 and 2025, and the related interim disclosures are unaudited. These unaudited consolidated financial statements include all adjustments necessary, consisting of only normal recurring adjustments, to fairly state the financial position and the results of operations and cash flows for interim periods in accordance with U.S. GAAP. Interim period results are not necessarily indicative of results of operations or cash flows for a full year or any subsequent interim period. The accompanying consolidated financial statements should be read in conjunction with the Company’s 2025 audited consolidated financial statements and the notes thereto. (c) Concentration of Credit Risk The Company maintains cash equivalent deposits, which at various times throughout the fiscal year exceeded the amounts insured by the Federal Deposit Insurance Corporation limit of $250,000 (without regard to reconciling items). Management monitors the soundness of these financial institutions and does not believe the Company is subject to any material credit risk relative to the uninsured portion of the deposits. (d) Impairment of Long-lived Assets The Company assesses the carrying value of its long-lived assets, including property and equipment, as well as lease right of use (ROU) assets, when events or circumstances indicate that the carrying value of such assets may not be recoverable. These events or changes in circumstances may include a significant deterioration of operating results, changes in business plans, or changes in anticipated future cash flows. If an impairment indicator is present, the Company evaluates recoverability by a comparison of the carrying amount of the assets to future undiscounted cash flows expected to be generated by the assets. If the sum of the expected future cash flows is less than the carrying amount, the Company would recognize an impairment loss. An impairment loss would be measured by comparing the amount by which the carrying value exceeds the fair value of the long-lived asset groups. No impairment was recognized during the three-month periods ended March 31, 2026 or 2025. (e) Stock-Based Compensation The Company measures employee and director stock-based compensation expense for all stock-based awards based on their grant date fair value using the Black-Scholes option-pricing model. For stock-based awards with service conditions, stock-based compensation expense is recognized over the requisite service period using the straight-line method. Forfeitures are recognized as they occur. See additional information in Note 10. (f) Derivative Instruments The Company evaluates all financial instruments, including certain equity-linked contracts, to determine if such instruments or any embedded components qualify as derivatives under ASC 815, Derivatives and Hedging. The Company evaluated the 2025 LP Purchase Agreement (as defined in Note 9) that includes the right to require Lincoln Park (as defined in Note 9) to purchase shares of common stock in the future (“purchased put right”) considering the guidance in ASC 815-40, Derivatives and Hedging, and concluded that it is an equity-linked contract that does not qualify for equity classification, and therefore requires fair value accounting as a derivative asset (liability). The Company has analyzed the terms of the purchased put right and has concluded that it had insignificant value as of March 31, 2026. 9 (g) Reclassifications In connection with the preparation of the interim financial statements as of and for the three and nine months ended September 30, 2025, the Company identified certain errors in its accounting for the Original LP Purchase Agreement in previously issued consolidated financial statements. Accordingly, the comparative financial statements included in this report differ from our previously filed Quarterly Report on Form 10-Q as of and for the three months ended March 31, 2025, reflecting the error correction for the misclassification of the commitment shares issued on the Original LP Purchase Agreement and change in fair value of the derivative initially recorded as a deduction to additional paid-in-capital on the consolidated statements of stockholders’ equity and now expensed through change in fair value of derivative on the consolidated statements of operations and comprehensive loss. The correction of this error resulted in an increase in change in fair value of derivative and net loss and net comprehensive loss; however, no change to total stockholders’ equity or net cash used in operating activities on the consolidated statements of cash flows. In evaluating whether the Company’s previously issued consolidated financial statements were materially misstated, the Company performed an analysis of quantitative and qualitative factors in accordance with Staff Accounting Bulletin (SAB) No. 99, Materiality, and SAB No. 108, Considering the Effects of Prior Year Misstatements when Quantifying Misstatements in Current Year Financial Statements, and considered the guidance in ASC Topic 250, Accounting Changes and Error Corrections. The Company believes the adjustments recorded for correction of the error are immaterial to the previously issued consolidated financial statements either individually or in the aggregate for each of the respective comparative periods. The corrections to the Company’s consolidated statements of operations and comprehensive loss were as follows: Schedule of Error Corrections and Prior Period Adjustments As Reported As Corrected Three Months Ended March 31, 2025 As Reported As Corrected Change in fair value of derivative - (49,987) Net loss and comprehensive loss $(3,802,691) $(3,852,678) Net loss per share of common stock, basic and diluted $(1.04) $(1.06) The corrections to the Company’s statement of stockholders’ equity were as follows: As Reported As Corrected As Reported As Corrected As Reported As Corrected Additional Paid-in-Capital Accumulated Deficit Stockholders’ Equity As Reported As Corrected As Reported As Corrected As Reported As Corrected Balance January 1, 2025 $115,944,345 $117,380,285 $(108,489,180) $(109,925,120) $7,455,505 $7,455,505 Activity for the three months to March 31, 2025: Change in fair value of derivative - 49,987 - - - 49,987 Net loss - - (3,802,691) (3,852,678) (3,802,691) (3,852,678) Balance March 31, 2025 $118,222,309 $119,708,236 $(112,291,871) $(113,777,798) $5,930,820 $5,930,820 The corrections of the Company’s statement of cash flows were as follows: As Reported As Corrected Three Months Ended March 31, 2025 As Reported As Corrected Operating activities: Net loss $(3,802,691) $(3,852,678) Adjustments to reconcile net loss to net cash used in operating activities: Adjustments to reconcile net loss to net cash used in operating activities: Change in fair value of derivative - 49,987 Net cash used in operating activities (4,608,282) (4,608,282) 10 (h) Segments Operating segments are defined as components of an enterprise for which discrete financial information is available and regularly reviewed by the chief operating decision maker (CODM) in deciding how to allocate resources and in assessing performance. The Company manages its business activities on a consolidated basis and operates as a single operating segment dedicated to the research and development and manufacturing of its product candidates. The Company’s CODM is its Chief Executive Officer. The CODM uses net loss, as reported in the Company’s Consolidated Statements of Operations and Comprehensive Loss, in evaluating performance of its segment and determining how to allocate resources of the Company as a whole, including investing in its research and development activities. The measure used by the CODM for segment assets is reported in the Consolidated Balance Sheets as total consolidated assets. The following table presents the operating results of the Company’s segment: Schedule of Operating Results of Company’s Segment Operating expenses: 2026 2025 Three Months Ended March 31, Operating expenses: 2026 2025 Research and development Clinical operations $53,778 $1,107,474 Drug manufacturing 1,166,737 380,353 Personnel 771,432 561,334 Regulatory 192,371 173,465 Total research and development 2,184,318 2,222,626 General and administrative Pre-commercialization costs 3,525,319 12,000 Personnel 1,116,210 571,530 Legal and professional fees 668,930 505,500 Occupancy 93,844 61,627 Insurance 149,506 195,596 Other 185,095 137,156 Total general and administrative 5,738,904 1,483,409 Operating loss (7,923,222) (3,706,035) Change in fair value of derivative (852,030) (49,987) Interest and income (expense), net (536,837) (96,656) Loss before income taxes (9,312,089) (3,852,678) Income tax benefit (expense) - - Net loss and comprehensive loss $(9,312,089) $(3,852,678) 11 (3) Prepaid Expenses and Other Current Assets Prepaid expenses and other current assets consisted of the following at March 31, 2026 and December 31, 2025: Schedule of Prepaid Expenses and Other Current Assets March 31, December 31, 2026 2025 Manufacturing materials $1,377,767 $813,381 Professional fees 270,000 - Marketing fees 112,500 125,000 Dues and subscriptions 62,915 11,743 Insurance 27,268 16,655 Deferred capital raise costs - 59,383 Other 115,898 20,700 Total prepaid expenses and other current assets $1,966,348 $1,046,862 (4) Property and Equipment Property and equipment, net consisted of the following at March 31, 2026 and December 31, 2025: Schedule of Property and Equipment Estimated Useful Life March 31, December 31, (in years) 2026 2025 Equipment 2-7 $4,662,280 $4,662,280 Furniture and fixtures 7 145,754 145,754 Computer equipment 5 46,994 46,994 Leasehold improvements 5 489,394 474,462 Construction-in-process - 279,648 233,397 Property and equipment, gross 5,624,070 5,562,887 Less: accumulated depreciation (3,958,153) (3,836,968) Property and equipment, net $1,665,917 $1,725,919 Depreciation expense was $121,185 and $165,291, respectively, for the three-month periods ended March 31, 2026 and 2025. 12 (5) Accrued Expenses Accrued expenses consisted of the following at March 31, 2026 and December 31, 2025: Schedule of Accrued Expenses March 31, December 31, 2026 2025 Pre-commercialization costs $721,947 $393,076 Manufacturing 355,450 - Interest 240,798 563,883 Employee compensation 195,997 455,177 Materials 165,430 - Research and development 80,000 166,696 State franchise taxes 55,000 44,000 Professional fees 40,000 31,542 Other 43,085 87,742 Total accrued expenses $1,897,707 $1,742,116 (6) Contingencies The Company may, from time to time, be subject to legal proceedings and claims arising in the ordinary course of business and otherwise. A substantial legal liability against us could have an adverse effect on our business, financial condition and results of operations. The Company records legal costs associated with loss contingencies as incurred and establishes reserves when those matters present material loss contingencies that management determines to be both probable and reasonably estimable in accordance with ASC 450, Contingencies. If a range of loss is estimated, and some amount within that range appears to be a better estimate than any other amount within that range, then that amount is accrued. If no amount within the range can be identified as a better estimate than any other amount, we accrue the minimum amount in the range. These amounts are not reduced by amounts that may be recovered under insurance or claims against third parties, but undiscounted receivables from insurers or other third parties may be accrued separately if recovery is considered probable. Management’s judgment is required related to loss contingencies because the outcomes are difficult to predict, and the ultimate resolution may differ from our current analysis. The Company revises accruals in light of new information. While it is not possible to predict the outcome of loss contingencies with certainty, management is of the opinion that adequate provision for potential losses associated with any such matters has been made in the financial statements. (7) Unsecured Promissory Note