Inhibikase Therapeutics(IKT) - 2025 Q2 - Quarterly Report

PART I. FINANCIAL INFORMATION Item 1. Condensed Consolidated Financial Statements (Unaudited) This section presents the unaudited condensed consolidated financial statements, including the balance sheets, statements of operations and comprehensive loss, statements of stockholders' equity, and statements of cash flows, along with detailed notes providing context on the company's business, liquidity, accounting policies, and specific financial items Condensed Consolidated Balance Sheets This section provides a snapshot of the company's financial position, detailing assets, liabilities, and equity at specific reporting dates Condensed Consolidated Balance Sheets (Unaudited) | Metric | June 30, 2025 | December 31, 2024 | | :------------------------------------ | :------------ | :-------------- | | Total Assets | $88,853,230 | $98,599,846 | | Cash and cash equivalents | $77,742,669 | $56,490,579 | | Marketable securities | $9,923,100 | $41,052,949 | | Total Liabilities | $8,799,545 | $3,733,566 | | Contingent consideration liability | $2,912,159 | $— | | Total Stockholders' Equity | $80,053,685 | $94,866,280 | Condensed Consolidated Statements of Operations and Comprehensive Loss This section details the company's financial performance over specific periods, including revenues, expenses, and net loss Condensed Consolidated Statements of Operations and Comprehensive Loss (Unaudited) – Three Months Ended June 30 | Metric | 2025 | 2024 | Change ($) | Change (%) | | :------------------------------------ | :----------- | :----------- | :----------- | :--------- | | Research and development | $(5,270,967) | $(3,075,830) | $(2,195,137) | 71.4% | | Selling, general and administrative | $(5,919,731) | $(1,974,705) | $(3,945,026) | 199.8% | | Change in fair value contingent consideration | $358,420 | $— | $358,420 | 100.0% | | Loss from operations | $(10,832,278) | $(5,050,535) | $(5,781,743) | 114.5% | | Interest income | $916,755 | $90,927 | $825,828 | 908.2% | | Net loss | $(9,915,523) | $(4,959,608) | $(4,955,915) | 99.9% | | Net loss per share – basic and diluted | $(0.11) | $(0.66) | | | Condensed Consolidated Statements of Operations and Comprehensive Loss (Unaudited) – Six Months Ended June 30 | Metric | 2025 | 2024 | Change ($) | Change (%) | | :------------------------------------ | :----------- | :----------- | :----------- | :--------- | | Research and development | $(15,784,546) | $(5,827,109) | $(9,957,437) | 170.9% | | Selling, general and administrative | $(11,169,022) | $(4,005,786) | $(7,163,236) | 178.8% | | Change in fair value contingent consideration | $1,523,284 | $— | $1,523,284 | 100.0% | | Loss from operations | $(25,430,284) | $(9,832,895) | $(15,597,389) | 158.6% | | Interest income | $1,836,026 | $223,652 | $1,612,374 | 720.9% | | Net loss | $(23,594,258) | $(9,609,243) | $(13,985,015) | 145.5% | | Net loss per share – basic and diluted | $(0.26) | $(1.38) | | | Condensed Consolidated Statements of Stockholders' Equity This section outlines changes in the company's equity, reflecting net income, stock-based compensation, and other equity transactions Total Stockholders' Equity | Date | Amount | | :--------------------- | :----------- | | December 31, 2024 | $94,866,280 | | June 30, 2025 | $80,053,685 | - Net loss for the six months ended June 30, 2025, was $(23,594,258)[19] - Stock-based compensation expense for the six months ended June 30, 2025, was $6,250,938[19] Condensed Consolidated Statements of Cash Flows This section details the company's cash inflows and outflows from operating, investing, and financing activities Condensed Consolidated Statements of Cash Flows (Unaudited) – Six Months Ended June 30 | Activity | 2025 | 2024 | | :------------------------------------ | :----------- | :----------- | | Net cash used in operating activities | $(9,677,761) | $(8,921,392) | | Net cash provided by (used in) investing activities | $30,898,080 | $(768,587) | | Net cash provided by financing activities | $31,771 | $3,611,255 | | Net increase (decrease) in cash and cash equivalents | $21,252,090 | $(6,078,724) | | Cash and cash equivalents at end of period | $77,742,669 | $3,086,455 | - Maturities of marketable securities provided $31,350,103 in cash for the six months ended June 30, 2025[24] - Acquired in-process research and development used $438,624 in cash for the six months ended June 30, 2025[24] Notes to Unaudited Condensed Consolidated Financial Statements This section provides detailed explanations and additional information supporting the condensed consolidated financial statements Note 1. Nature of Business This note describes the company's primary operations as a clinical-stage pharmaceutical company focused on protein kinase inhibitor therapeutics - Inhibikase Therapeutics, Inc. is a clinical-stage pharmaceutical company developing protein kinase inhibitor therapeutics for cardiopulmonary disease[27] - The lead product candidate is IKT-001, a novel oral prodrug of imatinib, for the treatment of Pulmonary Arterial Hypertension (PAH) as an orphan indication[27] - A Phase 2b study (IMPROVE-PAH) for approximately 150 PAH patients is expected to be initiated in the second half of 2025[27] Note 2. Liquidity This note discusses the company's cash position, accumulated deficit, and its ability to fund operations for the foreseeable future - As of June 30, 2025, the Company had cash, cash equivalents and marketable securities of approximately $87.7 million[28] - The Company had an accumulated deficit of approximately $118.0 million at June 30, 2025[29] - The Company estimates its current liquidity is sufficient to fund normal operations for at least the next twelve months[33] Note 3. Basis of Presentation and Significant Accounting Policies This note outlines the accounting principles used in preparing the financial statements, including US GAAP conformity and segment reporting - The unaudited condensed consolidated financial statements are prepared in conformity with US GAAP for interim periods[35] - The Company operates as one operating and reporting segment, focused on developing protein kinase inhibitor therapeutics[41] - Research and development costs are expensed as incurred, and no revenues were reported for the periods presented[47][48] Note 4. Fair Value of Financial Instruments This note details the fair value measurements of financial instruments, including cash equivalents, marketable securities, and contingent consideration Fair Value Measurements as of June 30, 2025 | Asset/Liability | Level 1 | Level 2 | Level 3 | Total | | :------------------------------------ | :----------- | :------ | :----------- | :----------- | | Cash equivalents: Money market funds | $43,316,602 | $— | $— | $43,316,602 | | Marketable securities: U.S. Treasury obligations | $9,923,100 | $— | $— | $9,923,100 | | Other current liabilities: Contingent consideration | $— | $— | $2,912,159 | $2,912,159 | Fair Value Measurements as of December 31, 2024 | Asset/Liability | Level 1 | Level 2 | Level 3 | Total | | :------------------------------------ | :----------- | :------ | :------ | :----------- | | Cash equivalents: Money market funds | $11,238,598 | $— | $— | $11,238,598 | | Marketable securities: U.S. Treasury obligations | $41,052,949 | $— | $— | $41,052,949 | - The change in fair value of contingent consideration for the six months ended June 30, 2025, was $(1,523,284)[70] Note 5. Marketable Securities This note provides details on the company's marketable securities, primarily U.S. Treasury obligations, including their amortized cost and fair value Marketable Securities (U.S. Treasury obligations) | Date | Amortized Cost | Unrealized Loss | Fair Value | | :--------------------- | :------------- | :-------------- | :----------- | | June 30, 2025 | $9,926,044 | $(2,944) | $9,923,100 | | December 31, 2024 | $41,090,197 | $(37,248) | $41,052,949 | - The Company received proceeds of $31.4 million from maturities of marketable securities for the six months ended June 30, 2025[73] Note 6. Equipment and Improvements This note presents the net book value of the company's equipment and improvements, along with associated depreciation expenses Equipment and Improvements, net | Date | Amount | | :--------------------- | :----------- | | June 30, 2025 | $23,687 | | December 31, 2024 | $47,100 | - Depreciation expense for the six months ended June 30, 2025, was $36,812, compared to $13,137 for the same period in 2024[74] Note 7. Supplemental Condensed Consolidated Balance Sheet Information This note provides a detailed breakdown of accrued expenses and other current liabilities on the balance sheet Accrued expenses and other current liabilities | Category | June 30, 2025 | December 31, 2024 | | :------------------------------------ | :------------ | :-------------- | | Accrued consulting | $483,679 | $202,379 | | Accrued compensation | $1,774,876 | $999,303 | | Accrued research and development | $813,017 | $1,397,348 | | Accrued other | $74,316 | $81,000 | | Total | $3,145,888 | $2,680,030 | Note 8. ATM Program/Open Market Sales Agreement This note describes the company's at-the-market equity offering programs, including termination of a prior agreement and initiation of a new one - The Company terminated its ATM Agreement with H.C. Wainwright & Co. on December 11, 2024, after selling 315,338 shares for $849,187 gross[76] - On June 20, 2025, the Company entered into a new Open Market Sale Agreement with Jefferies LLC to sell up to $200,000,000 of common stock[77] - As of June 30, 2025, no shares have been sold under the new Sales Agreement[77] Note 9. Stockholders' Equity This note details changes in stockholders' equity, including shares reserved for issuance, proceeds from offerings, and warrant-related transactions - As of June 30, 2025, 7,448,531 shares of common stock were reserved for issuance upon the exercise of outstanding stock options and warrants[79] - The October 2024 Offering closed with approximately $110 million in gross proceeds, with potential for up to $275 million upon full cash exercise of warrants[80] - The May 2024 Offering generated approximately $2.2 million in net proceeds and involved a warrant inducement agreement valued at $1.8 million[81][83] Note 10. Acquisition of CorHepta This note describes the acquisition of CorHepta Pharmaceuticals, Inc., focusing on the accounting treatment of in-process research and development - On February 21, 2025, the Company acquired CorHepta Pharmaceuticals, Inc. in an asset acquisition, with substantially all value attributed to in-process research and development (IPR&D)[84][86] - The acquisition involved issuing 4,979,101 shares of common stock, including 1,493,415 shares recognized as contingent consideration with a fair value of $4,435,443 at acquisition[84][88] - The acquired IPR&D asset of $7,357,294 was immediately written off as research and development expense[89] Note 11. ABLi License Agreement This note outlines the exclusive license agreement with ABLi Therapeutics, Inc. for risvodetinib, including milestone and royalty payment eligibility - On May 5, 2025, the Company granted ABLi Therapeutics, Inc. an exclusive, royalty-bearing license for risvodetinib (IKT-148009) globally[90] - ABLi is solely responsible for all further development and commercialization activities and costs[90] - The Company is eligible to receive development and regulatory milestone payments up to $47.5 million and double-digit royalty payments, but milestone achievement is not yet probable[92][93] Note 12. Stock-Based Compensation This note details the company's stock-based compensation plans, including equity incentive plan amendments and restricted share issuances - The 2020 Equity Incentive Plan was amended in January 2025 to increase available shares to 31,424,909 and in June 2025 to add an evergreen provision[96] - 1,660,222 restricted shares were issued in connection with the CorHepta acquisition, subject to service- and performance-based vesting conditions[97] Total Stock-Based Compensation Expense | Period | 2025 | 2024 | | :------------------------------------ | :----------- | :----------- | | Three Months Ended June 30 | $4,208,742 | $30,697 | | Six Months Ended June 30 | $6,250,938 | $84,131 | Note 13. Warrants This note provides information on warrants issued, including their exercise price and expiration date - In January 2025, the Company issued 702,625 warrants to a non-financial investor with an exercise price of $1.7125 and an expiration date of January 25, 2028[104] Note 14. Net Loss Per Share This note presents the basic and diluted net loss per share, along with a reconciliation of potentially dilutive securities Net Loss Per Share – Basic and Diluted (Six Months Ended June 30) | Metric | 2025 | 2024 | | :------------------------------------ | :----------- | :----------- | | Net loss per share | $(0.26) | $(1.38) | | Weighted-average number of shares | 89,774,703 | 6,939,779 | Potentially Dilutive Securities Excluded from Diluted EPS (Six Months Ended June 30, 2025) | Type | Number of Shares | | :------------------------------------ | :--------------- | | Options to purchase shares of stock | 37,020,275 | | Warrants to purchase shares of stock | 140,640,299 | | Restricted common stock | 1,660,222 | | Contingent consideration | 2,489,030 | | Total | 181,809,826 | Note 15. Income Taxes This note explains the absence of income tax provision due to losses and valuation allowances, and the impact of recent tax legislation - No provision for income taxes was recorded due to incurred losses and a full valuation allowance against deferred tax assets[108] - The Company is evaluating the impact of the recently passed 'One Big Beautiful Bill' (OBBB) but does not expect a material impact[109] Note 16. Commitments and Contingencies This note discloses the company's legal proceedings, if any, and its contractual obligations, including operating lease commitments - The Company is not currently a party to any material litigation or legal proceedings[110] - The Company has an operating lease for office space in Lexington, Massachusetts, expiring September 30, 2025, with a total lease obligation of $37,944 as of June 30, 2025[111][115] Note 17. Segment Information This note clarifies that the company operates as a single reportable segment and provides a breakdown of research and development expenses by program - The Company operates as one operating and reportable segment, focused on developing protein kinase inhibitor therapeutics[117] Research and Development Expenses (excluding stock-based compensation) – Six Months Ended June 30 | Program | 2025 | 2024 | | :------------------------------------ | :----------- | :----------- | | PAH (includes $7.4M IPR&D write-off) | $12,069,638 | $— | | Parkinson's disease | $184,616 | $5,010,004 | | Other programs | $1,421,270 | $806,881 | Note 18. Subsequent Event This note discloses significant events occurring after the reporting period, including clinical trial agreements for the IMPROVE-PAH study - In July 2025, the Company entered a clinical trial supply agreement for approximately $6.5 million for the IMPROVE-PAH study[119] - On August 8, 2025, the Company entered an arrangement with a contract research organization for approximately $22.3 million to support the IMPROVE-PAH study[120] Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations This section provides a narrative analysis of the company's financial condition and results of operations, detailing its business overview, the development status of its lead product candidate IKT-001 for PAH, the components of its operating expenses, a comparison of financial results for the three and six months ended June 30, 2025 and 2024, its liquidity and capital resources, and critical accounting policies Overview This section provides a high-level summary of the company's business, focusing on its clinical-stage pharmaceutical development and lead product candidates - The Company is a clinical-stage pharmaceutical company developing therapeutics for cardiopulmonary diseases, with a focus on Pulmonary Arterial Hypertension (PAH)[123] - The lead product candidate is IKT-001 for PAH, an orphan indication[123] - The risvodetinib (IkT-148009) program for Parkinson's disease has been discontinued and outlicensed[124] IKT-001 and PAH This section details the development of IKT-001 for Pulmonary Arterial Hypertension, including its bioequivalence, regulatory pathway, and market potential - IKT-001 is a novel oral prodrug of imatinib mesylate, designed to improve gastrointestinal side effects[125] - Bioequivalence was established with 300 mg IKT-001 to 230 mg imatinib mesylate and 500 mg IKT-001 to 383 mg imatinib mesylate[125] - The FDA acknowledged the 505(b)(2) pathway for approval, potentially granting New Molecular Entity (NME) status and market exclusivity[126][131] - A Phase 2b study (IMPROVE-PAH) for approximately 150 PAH patients is expected to initiate in the second half of 2025, with the primary efficacy endpoint being change in pulmonary vascular resistance (PVR) at Week 26[123][134] - The global PAH market size was valued at $7.66 billion in 2023 and is estimated to grow at a compound annual growth rate of 5.4% between 2024 to 2030[127] - Commercialization rights for IKT-001 and patent protection in the U.S. extend until 2033, with potential extensions to 2045 for certain methods of treatment[135] Components of Operating Results This section breaks down the key components contributing to the company's operating results, including research and development and selling, general and administrative expenses Research and Development This section discusses the nature and trends of research and development expenses, including program-specific costs and future expectations - Research and development expenses are recorded as incurred and include external costs tracked on a program-specific basis[136][137] - R&D expenses are expected to increase for the next several years as the Company advances programs and seeks regulatory approvals[140] Research and Development Expenses – Six Months Ended June 30 | Program | 2025 | 2024 | Change ($) | | :------------------------------------ | :----------- | :----------- | :----------- | | Parkinson's disease | $184,616 | $5,010,004 | $(4,825,388) | | PAH (includes $7.4M IPR&D write-off) | $12,069,638 | $— | $12,069,638 | | Other research and development expenses | $3,530,292 | $817,105 | $2,713,187 | | Total research and development expenses | $15,784,546 | $5,827,109 | $9,957,437 | Selling, General and Administrative This section outlines the components of selling, general and administrative expenses and their anticipated future trends - Selling, general and administrative expenses include personnel-related expenses, outside professional services, and allocated office expenses[142] - These expenses are expected to increase due to public company compliance and increased administrative headcount[143] Results of Operations This section provides a comparative analysis of the company's financial performance for the three and six months ended June 30, 2025 and 2024 Comparison of the Three Months Ended June 30, 2025 and 2024 This section compares the company's financial performance for the three months ended June 30, 2025, against the prior comparable period - Net loss increased by 99.9% to $(9,915,523) for the three months ended June 30, 2025, from $(4,959,608) in the prior comparable period[145] - Research and development expenses increased by 71.4% to $5,270,967, primarily due to a $2.7 million increase in PAH expenses[146] - Selling, general and administrative expenses increased by 199.8% to $5,919,731, driven by a $1.4 million increase in personnel-related costs and $2.5 million in stock-based compensation expense[147] - Interest income increased by 908.2% to $916,755[149] Comparison of the Six Months Ended June 30, 2025 and 2024 This section compares the company's financial performance for the six months ended June 30, 2025, against the prior comparable period - Net loss increased by 145.5% to $(23,594,258) for the six months ended June 30, 2025, from $(9,609,243) in the prior comparable period[150] - Research and development expenses increased by 170.9% to $15,784,546, including a $7.4 million non-cash charge for acquired IPR&D related to the CorHepta acquisition and $1.0 million of stock-based compensation expense[151] - Selling, general and administrative expenses increased by 178.8% to $11,169,022, driven by a $2.1 million increase in personnel-related costs and $4.1 million in stock-based compensation expense[152] - Interest income increased by 720.9% to $1,836,026[154] Liquidity and Capital Resources This section analyzes the company's ability to meet its financial obligations, including sources of funding, future requirements, and cash flow activities Sources of Liquidity This section identifies the primary sources of the company's liquidity, including proceeds from equity offerings and current cash holdings - The Company raised approximately $99.6 million in net proceeds from its October 2024 Offering[155] - On June 20, 2025, the Company entered into an Open Market Sale Agreement with Jefferies LLC to sell up to $200,000,000 of common stock, with no sales as of June 30, 2025[156] - At June 30, 2025, the Company had cash, cash equivalents and marketable securities of $87.7 million and an accumulated deficit of $118.0 million[157] Future Funding Requirements This section outlines the company's anticipated need for additional funding to support ongoing operations and product development initiatives - The Company expects to incur significant losses and will need substantial additional funding for continuing operations and product development[158] - Future funding may be sought through equity offerings, debt financings, working capital lines of credit, grant funding, and potential licenses and collaboration agreements[159] - Existing cash, cash equivalents, and marketable securities are believed to fund operating requirements for at least the next twelve months[162] Cash Flows This section summarizes the company's cash flows from operating, investing, and financing activities for the six months ended June 30 Summary of Cash Flows – Six Months Ended June 30 | Activity | 2025 | 2024 | | :------------------------------------ | :----------- | :----------- | | Net cash used in operating activities | $(9,677,761) | $(8,921,392) | | Net cash provided by (used in) investing activities | $30,898,080 | $(768,587) | | Net cash provided by financing activities | $31,771 | $3,611,255 | | Net increase (decrease) in cash and cash equivalents | $21,252,090 | $(6,078,724) | Contractual Obligations and Commitments This section details the company's contractual obligations, including lease commitments for office space - The Company's total lease obligation for its office space in Lexington, Massachusetts, was $37,944 at June 30, 2025, with the lease running through September 30, 2025[172] Critical Accounting Policies and Significant Judgments and Estimates This section describes the accounting policies and estimates that are crucial to the company's financial reporting, particularly for research and development and contingent consideration Research and Development Expenses This section explains the accounting treatment for research and development expenses, including the recognition of costs and estimation processes - Research and development expenses are recorded as incurred, including employee-related costs, external services, and acquired technologies without alternative future use[175] - Significant judgments and estimates are made in determining accrued R&D balances, particularly for third-party service providers[177] Contingent Consideration Liabilities This section details the accounting for contingent consideration liabilities, including asset acquisition evaluation and fair value remeasurement - Asset acquisitions are evaluated to determine if substantially all value is concentrated in a single identifiable asset, such as in-process research and development (IPR&D)[178][179] - Contingent consideration is recognized when probable and remeasured at fair value at each reporting date[181] - The acquired IPR&D asset of $7,357,294 from the CorHepta acquisition was immediately written off as research and development expense[182] Item 3. Quantitative and Qualitative Disclosures About Market Risk As a smaller reporting company, the Company is not required to provide quantitative and qualitative disclosures about market risk - The Company is not required to provide quantitative and qualitative disclosures about market risk as a smaller reporting company[183] Item 4. Controls and Procedures The principal executive and financial officers concluded that the Company's disclosure controls and procedures were effective at a reasonable assurance level as of June 30, 2025. There were no material changes in internal control over financial reporting during the period - Disclosure controls and procedures were effective at a reasonable assurance level as of June 30, 2025[184] - There were no material changes in internal control over financial reporting during the three and six months ended June 30, 2025[185] PART II. OTHER INFORMATION Item 1. Legal Proceedings The Company is not currently involved in any material litigation or legal proceedings, although it may encounter such matters in the ordinary course of business - The Company is not currently a party to any material litigation or legal proceedings[188] Item 1A. Risk Factors This section updates previously disclosed risk factors, highlighting potential adverse impacts from evolving healthcare legislative measures, dependence on third-party manufacturers in China, and changes in U.S. tax law - Healthcare legislative measures, including the Affordable Care Act, Inflation Reduction Act, and new executive orders on drug pricing, may adversely affect the Company's ability to profitably sell products and product candidates[190][195][197][199] - Dependence on third-party manufacturers located in China exposes the Company to risks associated with global business, including political uncertainty, trade policies, tariffs, and restrictions on personal data transfers[200][201][203][204] - Changes in U.S. tax law, such as the One Big Beautiful Bill Act (OBBBA), could adversely affect the Company's business and financial condition, particularly regarding the capitalization and amortization of research and development expenses[205][206] Item 2. Unregistered Sales of Equity Securities and Use of Proceeds The Company reported no unregistered sales of equity securities and no issuer repurchases of equity securities during the period - No unregistered sales of equity securities occurred[207] - No issuer repurchases of equity securities occurred[208] Item 3. Defaults Upon Senior Securities The Company reported no defaults upon senior securities during the period - No defaults upon senior securities were reported[209] Item 4. Mine Safety Disclosures This item is not applicable to the Company - This item is not applicable[210] Item 5. Other Information No directors or officers adopted or terminated a Rule 10b5-1 trading plan or arrangement during the fiscal quarter ended June 30, 2025 - No directors or officers adopted or terminated a Rule 10b5-1 trading plan or arrangement during the fiscal quarter ended June 30, 2025[211] Item 6. Exhibits This section lists all exhibits filed with the Quarterly Report, including corporate governance documents, equity incentive plan amendments, and certifications - The exhibits include amendments to the Certificate of Incorporation and Bylaws, the 2020 Equity Incentive Plan, and certifications from the Principal Executive Officer and Principal Financial Officer[213] Signatures The report is signed by the Chief Executive Officer and Chief Financial Officer of Inhibikase Therapeutics, Inc. on August 14, 2025 - The report was signed by Mark Iwicki (Chief Executive Officer) and David McIntyre (Chief Financial Officer) on August 14, 2025[219]