Core Insights - Inhibikase Therapeutics is expanding its therapeutic pipeline with multiple late-stage development assets targeting Parkinson's disease and related disorders [1][2] - The company anticipates completing the 201 Trial for untreated Parkinson's disease by the end of Q3 2024, with 94% enrollment achieved [2][5] - Inhibikase is redirecting efforts for IkT-001Pro into cardiopulmonary disease, specifically targeting Pulmonary Arterial Hypertension (PAH) [2][5] Company Updates - The company has initiated clinical development of its product candidates since 2021 and expects to have multiple late-stage ready assets by 2025 [2] - The 201 Trial is expected to report biomarker and outcome data to support discussions with the FDA for End of Phase 2 and Phase 3 protocols by the end of 2024 [5] - Inhibikase is seeking grant funding for the 202 Trial in Multiple System Atrophy through the National Institute of Neurological Diseases and Stroke (NINDS) [5] Strategic Developments - Following a pre-IND meeting with the FDA, Inhibikase plans to submit an IND application for IkT-001Pro for PAH early in Q3 2024 [5] - The company is scaling manufacturing processes for IkT-001Pro to support late-stage clinical development and NDA batch requirements [5] - Inhibikase will discontinue development of treatments for Progressive Multifocal Leukoencephalopathy (PML) to focus on late-stage clinical assets in neurodegeneration, cancer, and cardiopulmonary disease [5]

Core Viewpoint - Inhibikase Therapeutics, Inc. has entered into a securities purchase agreement to raise approximately $4.0 million through a registered direct offering and concurrent private placement, aimed at advancing its clinical-stage therapeutics for Parkinson's disease and related disorders [1][3]. Group 1: Securities Offering Details - The company will sell 1,672,452 shares of common stock at a price of $1.68 per share, along with Series A and Series B warrants, each with an exercise price of $1.68 [1][2]. - The Series A warrants will expire one year from stockholder approval, while the Series B warrants will expire five years from stockholder approval [1][2]. - The gross proceeds from the offering are estimated to be approximately $4.0 million before deducting fees and expenses [3]. Group 2: Warrant Inducement Agreement - Inhibikase has entered into a warrant inducement agreement with an investor to exercise outstanding warrants for 708,500 shares at an amended exercise price of $1.68 [2]. - The company will also issue Series C and Series D warrants, each with an exercise price of $1.68, which will have similar expiration terms as the Series A and B warrants [2]. Group 3: Company Overview - Inhibikase Therapeutics is focused on developing therapeutics for Parkinson's disease and related disorders, with its lead program targeting the treatment of neurodegeneration [6][7]. - The company is headquartered in Atlanta, Georgia, and has a multi-therapeutic pipeline that includes various drug delivery technologies and follow-on compounds [6][7].

Core Viewpoint - Inhibikase Therapeutics, Inc. has entered into a securities purchase agreement to raise approximately $4.0 million through a registered direct offering and concurrent private placement, aimed at advancing its clinical-stage development of therapeutics for Parkinson's disease and related disorders [1][3]. Group 1: Securities Offering Details - The company will sell 1,672,452 shares of common stock at a combined purchase price of $1.68, along with Series A and Series B warrants, each with an exercise price of $1.68 [1][2]. - The gross proceeds from the offering, including the concurrent private placement and warrant inducement, are estimated to be around $4.0 million before deducting fees and expenses [3]. - The offering is expected to close on or about May 22, 2024, subject to customary closing conditions [3]. Group 2: Warrant Inducement Agreement - Inhibikase has entered into a warrant inducement agreement with an investor to exercise outstanding warrants from January 2023, allowing the purchase of 708,500 shares at an amended exercise price of $1.68 [2]. - The company will also issue Series C and Series D warrants, each with an exercise price of $1.68, in connection with this agreement [2]. Group 3: Company Overview - Inhibikase Therapeutics is focused on developing protein kinase inhibitor therapeutics for Parkinson's disease and related disorders, with a lead program targeting the treatment of Parkinson's disease [6][7]. - The company's pipeline includes various therapeutic approaches for neurodegeneration and aims to improve patient experience with fewer side effects through innovative drug delivery technologies [7].

Core Viewpoint - Inhibikase Therapeutics is advancing its clinical programs, particularly focusing on Risvodetinib for Parkinson's disease and IkT-001Pro for various cancers, with significant milestones expected in 2024 [2][3]. Recent Developments and Upcoming Milestones - The Phase 2 201 trial for Risvodetinib is 83% enrolled, with final patient enrollment anticipated in June 2024, and results expected in the second half of the year [2][6]. - Positive interactions with the FDA regarding IkT-001Pro for gastrointestinal and hematological cancers have been reported, with plans for a 505(b)(2) NDA submission [2][6]. - A Pre-IND meeting for IkT-001Pro in pulmonary arterial hypertension confirmed its classification as a novel chemical entity, with FDA support for the initial Phase 2/3 design [6]. First Quarter Financial Results - The net loss for Q1 2024 was $4.6 million, or $0.73 per share, compared to a net loss of $4.5 million, or $0.98 per share in Q1 2023 [4][16]. - Research and development expenses decreased to $2.8 million from $2.9 million year-over-year, while selling, general, and administrative expenses increased to $2.0 million from $1.9 million [5][7]. - Cash, cash equivalents, and marketable securities totaled $9.7 million as of March 31, 2024, expected to fund operations through November 2024 [8]. Financial Position - Total assets as of March 31, 2024, were $11.1 million, down from $14.5 million at the end of 2023 [14]. - Current liabilities increased to $4.2 million from $3.4 million, with total liabilities at $4.3 million [14]. - Stockholders' equity decreased to $6.8 million from $11.0 million, reflecting an accumulated deficit of $71.6 million [14].

BOSTON and ATLANTA, May 15, 2024 (GLOBE NEWSWIRE) -- Inhibikase Therapeutics, Inc. (Nasdaq: IKT) (Inhibikase or Company), a clinical-stage pharmaceutical company developing protein kinase inhibitor therapeutics to modify the course of Parkinson's disease ("PD"), Parkinson's-related disorders and other diseases of the Abelson Tyrosine Kinases, today reported financial results for the first quarter ended March 31, 2024 and highlighted recent developments. "2024 is shaping up to be a year of clinical and regul ...

PART I. FINANCIAL INFORMATION [Item 1. Condensed Consolidated Financial Statements (Unaudited)](index=3&type=section&id=Item%201.%20Condensed%20Consolidated%20Financial%20Statements%20%28Unaudited%29) This section presents Inhibikase Therapeutics' unaudited condensed consolidated financial statements, including balance sheets, operations, equity, and cash flows for Q1 2024 [Condensed Consolidated Balance Sheets](index=3&type=section&id=Condensed%20Consolidated%20Balance%20Sheets) The balance sheet shows a decrease in total assets and stockholders' equity from December 2023 to March 2024, driven by reduced cash and increased accumulated deficit | Metric | March 31, 2024 ($) | December 31, 2023 ($) | | :-------------------------------- | :------------- | :---------------- | | Cash and cash equivalents | $2,353,346 | $9,165,179 | | Marketable securities | $7,396,009 | $4,086,873 | | Total current assets | $10,807,834 | $14,211,048 | | Total assets | $11,068,098 | $14,506,647 | | Total current liabilities | $4,233,117 | $3,438,601 | | Total liabilities | $4,291,447 | $3,528,725 | | Total stockholders' equity | $6,776,651 | $10,977,922 | | Accumulated deficit | $(71,550,360) | $(66,900,725) | [Condensed Consolidated Statements of Operations and Comprehensive Loss](index=4&type=section&id=Condensed%20Consolidated%20Statements%20of%20Operations%20and%20Comprehensive%20Loss) The company reported a **$4.65 million net loss** for Q1 2024, an increase from the prior year, primarily due to no grant revenue and lower interest income | Metric | Three Months Ended March 31, 2024 | Three Months Ended March 31, 2023 | | :-------------------------------------- | :-------------------------------- | :-------------------------------- | | Grant revenue ($) | $— | $64,521 | | Research and development ($) | $2,751,279 | $2,854,119 | | Selling, general and administrative ($) | $2,031,081 | $1,925,351 | | Total costs and expenses ($) | $4,782,360 | $4,779,470 | | Loss from operations ($) | $(4,782,360) | $(4,714,949) | | Interest income ($) | $132,725 | $237,171 | | Net loss ($) | $(4,649,635) | $(4,477,778) | | Net loss per share – basic and diluted ($) | $(0.73) | $(0.98) | | Weighted-average common shares (Shares) | 6,340,697 | 4,585,013 | [Condensed Consolidated Statements of Stockholders' Equity](index=5&type=section&id=Condensed%20Consolidated%20Statements%20of%20Stockholders%27%20Equity) Stockholders' equity decreased from **$10.98 million** (Dec 2023) to **$6.78 million** (Mar 2024), mainly due to net loss, partially offset by stock issuance | Metric | December 31, 2023 | March 31, 2024 | | :-------------------------------- | :---------------- | :------------- | | Common Stock (Shares) | 6,186,280 | 6,476,844 | | Common Stock (Amount) ($) | $6,186 | $6,477 | | Additional Paid-In Capital ($) | $77,871,584 | $78,322,334 | | Accumulated Other Comprehensive (Loss) Income ($) | $877 | $(1,800) | | Accumulated Deficit ($) | $(66,900,725) | $(71,550,360) | | Total Stockholders' Equity ($) | $10,977,922 | $6,776,651 | | Stock-based compensation expense ($) | — | $53,434 | | Issuance of common stock, pre-funded warrants and warrants, net of issuance costs ($) | — | $397,607 | [Condensed Consolidated Statements of Cash Flows](index=6&type=section&id=Condensed%20Consolidated%20Statements%20of%20Cash%20Flows) The company experienced a **$6.81 million net decrease** in cash and cash equivalents for Q1 2024, driven by operating and investing activities, partially offset by financing | Cash Flow Activity | Three Months Ended March 31, 2024 ($) | Three Months Ended March 31, 2023 ($) | | :-------------------------------- | :-------------------------------- | :-------------------------------- | | Net cash used in operating activities | $(3,867,018) | $(5,972,130) | | Net cash used in investing activities | $(3,311,814) | $(5,838,842) | | Net cash provided by financing activities | $366,999 | $8,579,023 | | Net decrease in cash and cash equivalents | $(6,811,833) | $(3,231,949) | | Cash and cash equivalents at end of period | $2,353,346 | $3,956,604 | [Notes to Unaudited Condensed Consolidated Financial Statements](index=7&type=section&id=Notes%20to%20Unaudited%20Condensed%20Consolidated%20Financial%20Statements) These notes detail the company's business, financial condition, and accounting policies, highlighting its clinical-stage focus, going concern issues, and financial instrument valuations - The unaudited condensed consolidated financial statements are prepared in conformity with US GAAP and include all normal and recurring adjustments[29](index=29&type=chunk) - The Company qualifies as an 'emerging growth company' and has elected the extended transition period for complying with new or revised financial accounting standards[32](index=32&type=chunk) - A 1-for-6 reverse stock split was effected on June 30, 2023, and all common stock, options, warrant amounts, and per share information have been retroactively adjusted[33](index=33&type=chunk) [1. Nature of Business](index=7&type=section&id=1.%20Nature%20of%20Business) Inhibikase Therapeutics is a clinical-stage pharmaceutical company developing protein kinase inhibitors for Parkinson's disease and other Abelson Tyrosine Kinase diseases - The company is a clinical-stage pharmaceutical company developing protein kinase inhibitor therapeutics for Parkinson's disease (PD), Parkinson's-related disorders, and other diseases of the Abelson Tyrosine Kinases[19](index=19&type=chunk) - Lead program: **Risvodetinib (IkT-148009)** for Parkinson's disease, currently in Phase 2 clinical development ('the 201 trial')[19](index=19&type=chunk) - Other development: **IkT-001Pro**, a prodrug of imatinib mesylate, for Stable Phase Chronic Myelogenous Leukemia (SP-CML), which has completed a three-part dose finding/dose equivalence study ('the 501 trial')[20](index=20&type=chunk) [2. Going Concern](index=7&type=section&id=2.%20Going%20Concern) The company's recurring losses and **$71.55 million accumulated deficit** raise substantial doubt about its ability to continue as a going concern beyond November 2024 - The Company has recognized recurring losses and had an accumulated deficit of **$71,550,360** at March 31, 2024[22](index=22&type=chunk) - Working capital at March 31, 2024, including funds from the February 2024 At the Market Offering, is estimated to fund normal operations through **November 2024**[26](index=26&type=chunk) - These conditions raise substantial doubt about the Company's ability to continue as a going concern for one year after the financial statements are issued; management plans include additional equity raises, suspending/delaying research projects, and eliminating future operating expenses[27](index=27&type=chunk) [3. Basis of Presentation and Significant Accounting Policies](index=9&type=section&id=3.%20Basis%20of%20Presentation%20and%20Significant%20Accounting%20Policies) The unaudited condensed consolidated financial statements adhere to US GAAP and SEC interim reporting rules, reflecting the company's 'emerging growth company' status and a retroactive 1-for-6 reverse stock split [Basis of Presentation of Interim Financial Statements](index=9&type=section&id=Basis%20of%20Presentation%20of%20Interim%20Financial%20Statements) Interim financial statements are unaudited, prepared per SEC rules, with the December 31, 2023 balance sheet derived from audited statements, and interim results are not indicative of full-year outcomes - The unaudited condensed consolidated financial statements were prepared by the Company pursuant to SEC rules and regulations for interim financial statements[29](index=29&type=chunk) - The December 31, 2023 balance sheet was derived from audited financial statements[29](index=29&type=chunk) - Results for the interim periods are not necessarily indicative of results to be expected for the fiscal year ending December 31, 2024[29](index=29&type=chunk) [Use of Estimates](index=9&type=section&id=Use%20of%20Estimates) Financial statement preparation requires management estimates for liquidity, fair value of stock options, deferred tax allowances, and revenue recognition, based on historical data and market assumptions, with actual results potentially differing - Management makes estimates and assumptions affecting reported amounts in financial statements, including liquidity, fair value of stock options and warrants, deferred tax valuation allowances, and revenue recognition[34](index=34&type=chunk) - Estimates are based on historical experience and market-specific or other relevant assumptions[34](index=34&type=chunk) - Actual results could differ from such estimates[34](index=34&type=chunk) [New Accounting Pronouncements](index=9&type=section&id=New%20Accounting%20Pronouncements) The company adopts new accounting pronouncements on their effective dates and anticipates no material impact on its condensed consolidated financial statements from recently issued standards - The Company adopts new accounting pronouncements as of the specified effective date[35](index=35&type=chunk) - The Company does not believe that the adoption of recently issued standards will have a material impact on its condensed consolidated financial statements and disclosures[35](index=35&type=chunk) [Concentrations of Credit Risk](index=10&type=section&id=Concentrations%20of%20Credit%20Risk) The company reported no revenue for Q1 2024, while in Q1 2023, **100% of total revenue** was derived from federal research grants from the United States Government - For the three months ended March 31, 2024, the Company did not report any revenues[36](index=36&type=chunk) - For the three months ended March 31, 2023, **100% of total revenue** was from federal research grants from the United States Government[36](index=36&type=chunk) [Revenue Recognition](index=10&type=section&id=Revenue%20Recognition) Revenue from research and development grants, outside ASC Topic 606, is recognized as qualifying expenses are incurred, with advance cash recorded as deferred revenue - Revenue is generated from research and development grants under contracts with third parties that do not create customer-vendor relationships[37](index=37&type=chunk) - Contribution revenue from grants is reported as grant revenue and recognized as qualifying expenses are incurred[37](index=37&type=chunk) - Cash received from grants in advance of incurring qualifying expenses is recorded as deferred revenue[37](index=37&type=chunk) [Research and Development Costs](index=10&type=section&id=Research%20and%20Development%20Costs) Research and development costs are expensed as incurred, including salaries, stock compensation, and subcontractor fees, with **$90 thousand in related party R&D expenses** in Q1 2024 - Costs incurred in research and development of product candidates are expensed as incurred[38](index=38&type=chunk) - R&D expenses include salaries, benefits, stock compensation, research-related subcontractors and consultants, supplies, and overhead costs[38](index=38&type=chunk) | Metric | Three Months Ended March 31, 2024 ($) | Three Months Ended March 31, 2023 ($) | | :-------------------------------- | :-------------------------------- | :-------------------------------- | | Related party R&D expenses | ~$90,000 | ~$0 | | Related party payable balance | ~$109,000 | ~$57,000 | [Leases](index=10&type=section&id=Leases) The company accounts for leases under ASC Topic 842, recognizing right-of-use assets and lease liabilities, classifying them as finance or operating, and not recognizing short-term leases on the balance sheet - The Company accounts for its leases under ASU 2021-09, ASU 2018-10, and ASC Topic 842, Leases[39](index=39&type=chunk) - A right-of-use asset and a lease liability are recognized for all leases at commencement, with the lease liability representing the present value of lease payments[41](index=41&type=chunk)[42](index=42&type=chunk) - The Company has elected not to recognize leases with an initial term of **12 months or less** on its condensed consolidated balance sheets[45](index=45&type=chunk) [Equipment and Improvements](index=12&type=section&id=Equipment%20and%20Improvements) Equipment and improvements are recorded at cost less accumulated depreciation, with straight-line depreciation over estimated useful lives of **three to five years** for various asset categories - Equipment and improvements are stated at cost, less accumulated depreciation[46](index=46&type=chunk) - Depreciation is recognized using the straight-line method over estimated useful lives of **three to five years** for network equipment, office equipment, and furniture[46](index=46&type=chunk) | Asset Type | Estimated Useful Economic Life (Years) | | :-------------------------------- | :----------------------------- | | Leasehold property improvements, right of use assets | Lesser of lease term or useful life | | Furniture and office equipment | 3-5 | | Lab equipment | 3 | | IT equipment | 3 | [Fair Value Measurement](index=12&type=section&id=Fair%20Value%20Measurement) Financial assets and liabilities are classified into Level 1, 2, or 3 of the fair value hierarchy, with cash equivalents and marketable securities valued using transaction price, third-party pricing, and industry models - Financial assets and liabilities recorded at fair value are classified as Level 1, 2, or 3 within the fair value hierarchy[48](index=48&type=chunk) - Level 1 uses quoted prices in active markets; Level 2 uses quoted prices for identical/similar assets or other market observable inputs; Level 3 uses unobservable inputs reflecting the Company's assumptions[48](index=48&type=chunk) - Cash equivalents and marketable securities are initially valued at transaction price and revalued using third-party pricing services and industry standard valuation models[49](index=49&type=chunk) [Marketable Securities](index=12&type=section&id=Marketable%20Securities) Marketable securities, primarily U.S. Treasury securities with maturities under one year, are classified as available-for-sale, carried at fair value, and reviewed quarterly for impairment - Marketable securities consist of U.S. Treasury securities with maturities of less than one year, classified as available-for-sale[50](index=50&type=chunk) - Available-for-sale debt securities are carried at fair value with unrealized gains and losses reported as a component of stockholders' equity[50](index=50&type=chunk) - Securities are reviewed for possible impairment at least quarterly; other-than-temporary impairment results in adjusting the cost basis to fair market value and reporting a realized loss[51](index=51&type=chunk) [4. Fair Value of Financial Instruments](index=12&type=section&id=4.%20Fair%20Value%20of%20Financial%20Instruments) The company's cash equivalents and marketable securities are measured at fair value on a recurring basis, all classified as **Level 1**, reflecting valuation using quoted prices in active markets | Financial Instrument | March 31, 2024 ($) | December 31, 2023 ($) | | :-------------------------------- | :----------------------- | :------------------------ | | Money market funds | $1,707,544 | $8,039,024 | | U.S. treasury obligations | $7,396,009 | $4,086,873 | [5. Marketable Securities](index=13&type=section&id=5.%20Marketable%20Securities) As of March 31, 2024, marketable securities had a fair value of **$7.396 million** with an unrealized loss of **$1,800**, contrasting with a **$4.087 million** fair value and **$877** unrealized gain in Dec 2023 | Metric | March 31, 2024 ($) | December 31, 2023 ($) | | :-------------------------------- | :------------- | :---------------- | | Amortized Cost | $7,397,809 | $4,085,996 | | Unrealized Gain | $— | $877 | | Unrealized Loss | $(1,800) | $— | | Fair Value | $7,396,009 | $4,086,873 | - As of March 31, 2024, the Company held twenty-one U.S. Treasury debt securities in an unrealized loss position totaling **$1,800**[56](index=56&type=chunk) - All U.S. Treasury obligations were due to mature in less than one year for both periods[56](index=56&type=chunk) [6. Equipment and Improvements](index=13&type=section&id=6.%20Equipment%20and%20Improvements) Net equipment and improvements decreased to **$66,804** (Mar 2024) from **$73,372** (Dec 2023), primarily due to **$6,568** in depreciation expense for Q1 2024 | Category | March 31, 2024 ($) | December 31, 2023 ($) | | :-------------------------------- | :------------- | :---------------- | | Furniture and office equipment | $86,930 | $86,930 | | IT equipment | $16,895 | $16,895 | | Total cost | $103,825 | $103,825 | | Less: Accumulated Depreciation | $37,021 | $30,453 | | Total | $66,804 | $73,372 | - Depreciation expense for the period ended March 31, 2024, was **$6,568**[60](index=60&type=chunk) [7. Supplemental Balance Sheet Information](index=14&type=section&id=7.%20Supplemental%20Balance%20Sheet%20Information) Accrued expenses and other current liabilities increased to **$2.51 million** (Mar 2024) from **$2.26 million** (Dec 2023), mainly due to higher accrued research and development expenses | Category | March 31, 2024 ($) | December 31, 2023 ($) | | :-------------------------------- | :------------- | :---------------- | | Accrued consulting | $68,460 | $49,395 | | Accrued compensation | $325,059 | $635,451 | | Accrued research and development | $2,088,509 | $1,472,292 | | Accrued other | $25,561 | $102,817 | | Total accrued expenses and other current liabilities | $2,507,589 | $2,259,955 | [8. Stockholders' Equity](index=14&type=section&id=8.%20Stockholders%27%20Equity) As of March 31, 2024, **6,476,844 common shares** were outstanding, with **1,215,481 reserved** for options and warrants; Q1 2024 ATM sales generated **$397,607** net proceeds - As of March 31, 2024, **6,476,844 shares** of common stock were issued and outstanding[9](index=9&type=chunk) - **1,215,481 shares** of common stock were reserved for issuance upon the exercise of outstanding stock options and warrants[62](index=62&type=chunk) - On February 1, 2024, the Company entered into an At The Market Offering (ATM) agreement to sell up to approximately **$5.7 million** in common stock; as of March 31, 2024, **290,564 ATM Shares** were sold, generating net proceeds of **$397,607**[63](index=63&type=chunk)[64](index=64&type=chunk) - The January 2023 Offering generated approximately **$8.5 million** in net proceeds, involving common stock, common warrants, and pre-funded warrants[65](index=65&type=chunk)[66](index=66&type=chunk) [9. Stock-Based Compensation](index=16&type=section&id=9.%20Stock-Based%20Compensation) Stock-based compensation expense decreased to **$53,434** in Q1 2024 from **$123,273** in Q1 2023, with fewer options granted at a lower weighted average strike price | Category | Three Months Ended March 31, 2024 ($) | Three Months Ended March 31, 2023 ($) | | :-------------------------------- | :-------------------------------- | :-------------------------------- | | Research and development | $17,931 | $38,618 | | Selling, general and administrative | $35,503 | $84,655 | | Total stock-based compensation expense | $53,434 | $123,273 | - During Q1 2024, **18,039 options** were granted with a weighted average strike price of **$2.55**[69](index=69&type=chunk) - During Q1 2023, **75,000 options** were granted (50,000 regular, 25,000 performance-based) with a weighted average strike price of **$4.44**[70](index=70&type=chunk) [10. ATM Program](index=16&type=section&id=10.%20ATM%20Program) On February 1, 2024, the company initiated an ATM program to sell up to **$5.7 million** in common stock, selling **290,564 shares** for **$397,607** net proceeds by March 31, 2024 - On February 1, 2024, the Company entered into an At The Market Offering (ATM) agreement to issue and sell shares of its common stock up to approximately **$5.7 million**[73](index=73&type=chunk) - As of March 31, 2024, **290,564 ATM Shares** have been sold, resulting in net proceeds of **$397,607** to the Company[75](index=75&type=chunk) - The sales agent, H.C. Wainwright & Co., LLC, is entitled to a fixed commission of **3.0%** of the aggregate gross proceeds from the shares sold[74](index=74&type=chunk) [11. Net Loss Per Share](index=18&type=section&id=11.%20Net%20Loss%20Per%20Share) Basic and diluted net loss per share improved to **$(0.73)** in Q1 2024 from **$(0.98)** in Q1 2023, despite a higher net loss, due to more weighted-average common shares outstanding | Metric | Three Months Ended March 31, 2024 | Three Months Ended March 31, 2023 | | :-------------------------------- | :-------------------------------- | :-------------------------------- | | Net loss ($) | $(4,649,635) | $(4,477,778) | | Weighted-average number of common shares outstanding – basic and diluted (Shares) | 6,340,697 | 4,585,013 | | Net loss per share – basic and diluted ($) | $(0.73) | $(0.98) | - Options and warrants totaling **3,112,802 shares** (2024) and **4,036,955 shares** (2023) were excluded from diluted EPS calculation as their effect would have been anti-dilutive[76](index=76&type=chunk) [12. Income Taxes](index=18&type=section&id=12.%20Income%20Taxes) No income tax provision was recorded for Q1 2024 or Q1 2023 due to incurred losses, and a full valuation allowance was recorded against deferred tax assets due to realization uncertainty - No provision for income taxes was recorded for the three months ended March 31, 2024 and 2023, due to incurred losses[77](index=77&type=chunk) - A full valuation allowance was recorded against deferred tax assets, as their realization is not considered more likely than not[77](index=77&type=chunk) [13. Commitments and Contingencies](index=18&type=section&id=13.%20Commitments%20and%20Contingencies) The company faces a **$1.625 million** arbitration demand from Pivot Holding LLC for alleged unpaid milestone payments and has an operating lease for office space with **$227,803** in future minimum payments - On April 26, 2024, the Company received a demand for arbitration from Pivot Holding LLC alleging breach of contract for **$1.625 million** in milestone payments[78](index=78&type=chunk) - The Company believes Pivot's claims are without merit and intends to vigorously dispute them[78](index=78&type=chunk) - The parties have agreed to mediate before arbitration, with the Company's response due by June 17, 2024[78](index=78&type=chunk) | Year | Future Minimum Lease Payments ($) | | :--- | :---------------------------- | | 2024 | $112,837 | | 2025 | $114,966 | | Total lease payments | $227,803 | | Less: imputed interest | $(18,314) | | Present value of operating lease liabilities | $209,489 | [Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations](index=21&type=section&id=Item%202.%20Management%27s%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) This section provides management's discussion and analysis of the company's financial condition and operational results for Q1 2024, detailing clinical programs, liquidity, and critical accounting policies [Forward-Looking Statements](index=21&type=section&id=Forward-Looking%20Statements) This section contains forward-looking statements about future expectations, clinical trials, and financial performance, subject to significant risks and uncertainties inherent in drug development, where actual results may differ materially - The report contains forward-looking statements regarding future expectations, clinical trials, financial condition, and business strategy[85](index=85&type=chunk)[86](index=86&type=chunk) - Key risks include limited resources, difficulty raising additional capital, substantial doubt about going concern, potential clinical holds, and the uncertain nature of drug development and commercialization[88](index=88&type=chunk)[89](index=89&type=chunk) - Forward-looking statements are based on current expectations and are not guarantees of future performance; actual results may differ materially due to various factors and risks[86](index=86&type=chunk)[90](index=90&type=chunk) [Overview](index=23&type=section&id=Overview) Inhibikase is advancing **Risvodetinib** for Parkinson's disease (Phase 2) and Multiple System Atrophy (Orphan Drug Designation), and **IkT-001Pro** for SP-CML and Pulmonary Arterial Hypertension, with patent protection - **Risvodetinib (IkT-148009)** is in a Phase 2 program ('the 201 trial') for Parkinson's disease, with **99 participants enrolled** and **44 completing the 12-week dosing period** as of May 10, 2024; the company plans to extend the trial by up to **12 months**[94](index=94&type=chunk) - **Risvodetinib (IkT-148009)** received Orphan Drug Designation from the FDA for Multiple System Atrophy (MSA), and the company plans to initiate a Phase 2 study in MSA patients[96](index=96&type=chunk) - For **IkT-001Pro**, bioequivalence to **400 mg imatinib mesylate** has been established with a **600 mg dose**, and a **900 mg dose** is preferred for **600 mg imatinib mesylate** equivalence; the FDA acknowledged the 505(b)(2) pathway for approval[97](index=97&type=chunk)[98](index=98&type=chunk) - The company is evaluating **IkT-001Pro** for Pulmonary Arterial Hypertension (PAH), with the FDA confirming it would be viewed as a New Molecular Entity (NME) for PAH, potentially granting patent exclusivity[100](index=100&type=chunk) - The company's patent portfolio includes **nine issued U.S. patents** and **four pending applications**, with patents expiring between **2033 and 2037** for IkT-001Pro and Risvodetinib, respectively[106](index=106&type=chunk)[107](index=107&type=chunk)[109](index=109&type=chunk) [Components of Operating Results](index=29&type=section&id=Components%20of%20Operating%20Results) Operating results are primarily influenced by research and development (R&D) and selling, general and administrative (SG&A) expenses, which are expensed as incurred and expected to increase with product development [Operating Expenses](index=29&type=section&id=Operating%20Expenses) Operating expenses primarily comprise research and development (R&D) and selling, general and administrative (SG&A) costs, which are key components of the company's financial performance - Operating expenses are primarily composed of research and development and selling, general and administrative costs[110](index=110&type=chunk)[116](index=116&type=chunk) [Research and Development](index=29&type=section&id=Research%20and%20Development) Research and development expenses are recorded as incurred, including external and internal costs, tracked program-specifically, and are expected to increase as the company advances its programs and seeks regulatory approvals - Research and development expenses are recorded as incurred and include external costs (CROs, preclinical/clinical testing, CMOs, consultants) and personnel-related expenses[110](index=110&type=chunk)[112](index=112&type=chunk) - Direct external expenses are tracked on a program-specific basis, while personnel and other operating expenses are not tracked program-specifically[111](index=111&type=chunk) - R&D expenses are expected to increase for the next several years as the company advances programs, expands efforts, and seeks regulatory approvals[114](index=114&type=chunk) | Program | Three Months Ended March 31, 2024 ($) | Three Months Ended March 31, 2023 ($) | Change ($) | | :-------------------------------- | :-------------------------------- | :-------------------------------- | :--------- | | PD | $2,343,896 | $1,757,447 | $586,449 | | MSA | $43,352 | $75,300 | $(31,948) | | CML | $80,220 | $818,046 | $(737,826) | | Other research and development expenses | $283,811 | $203,326 | $80,485 | | Total research and development expenses | $2,751,279 | $2,854,119 | $(102,840) | [Selling, General and Administrative](index=30&type=section&id=Selling%2C%20General%20and%20Administrative) Selling, general and administrative (SG&A) expenses include personnel, professional services, and allocated office costs, increasing due to public company compliance and administrative headcount needs for clinical development - SG&A expenses include personnel-related expenses (salaries, benefits, stock-based compensation), outside professional services (legal, accounting, investor relations), and allocated rent expenses[116](index=116&type=chunk) - The company is incurring additional expenses as a public company, including compliance costs, increased insurance, investor relations, and administrative headcount[117](index=117&type=chunk) [Results of Operations](index=31&type=section&id=Results%20of%20Operations) For Q1 2024, the company reported a **$4.65 million net loss**, a **3.8% increase** from the prior year, driven by a **100% decrease in grant revenue** and **44% decrease in interest income** | Metric | Three Months Ended March 31, 2024 ($) | Three Months Ended March 31, 2023 ($) | Change ($) | Change (%) | | :-------------------------------- | :-------------------------------- | :-------------------------------- | :--------- | :--------- | | Grant revenue | $— | $64,521 | $(64,521) | (100.0) | | Research and development | $(2,751,279) | $(2,854,119) | $102,840 | (3.6) | | Selling, general and administrative | $(2,031,081) | $(1,925,351) | $(105,730) | 5.5 | | Loss from operations | $(4,782,360) | $(4,714,949) | $(67,411) | 1.4 | | Interest income | $132,725 | $237,171 | $(104,446) | (44.0) | | Net loss | $(4,649,635) | $(4,477,778) | $(171,857) | 3.8 | [Grant Revenue](index=31&type=section&id=Grant%20Revenue) Grant revenue decreased by **100% to $0** for Q1 2024, from **$64,521** in Q1 2023, as Phase I and II clinical trials were not submitted for grant revenue - Grant revenue decreased by **$64,521** or **100.0% to $0** for the three months ended March 31, 2024[119](index=119&type=chunk) - The decrease is attributed to Phase I and II clinical trials not being submitted for grant revenue during 2024[119](index=119&type=chunk) [Research and Development](index=31&type=section&id=Research%20and%20Development) Research and development expenses decreased by **$102,840 (3.6%)** to **$2.75 million** in Q1 2024, driven by a **$0.7 million decrease** in IkT-001Pro expenses, partially offset by a **$0.6 million increase** in Risvodetinib expenses - Research and development expenses decreased by **$102,840** or **3.6%** to **$2,751,279**[120](index=120&type=chunk) - The decrease was due to a **$0.7 million decrease** in IkT-001Pro expenses, offset by a **$0.6 million increase** in Risvodetinib (IkT-148009) expenses[120](index=120&type=chunk) [Selling, General and Administrative](index=31&type=section&id=Selling%2C%20General%20and%20Administrative) Selling, general and administrative expenses increased by **$105,730 (5.5%)** to **$2.03 million** in Q1 2024, primarily due to a **$0.18 million increase** in legal and consulting fees - Selling, general and administrative expenses increased by **$105,730** or **5.5%** to **$2,031,081**[121](index=121&type=chunk) - The increase was primarily driven by a **$0.18 million increase** in legal and consulting fees[121](index=121&type=chunk) [Interest Income](index=31&type=section&id=Interest%20Income) Interest income decreased by **$0.11 million (44.0%)** to **$0.13 million** in Q1 2024, compared to **$0.24 million** in Q1 2023, due to interest on U.S. Treasuries and money market instruments - Interest income decreased by **$0.11 million** or **44.0%** to **$0.13 million**[122](index=122&type=chunk) - The decrease was driven by interest earned on U.S. Treasuries and money market instruments[122](index=122&type=chunk) [Liquidity and Capital Resources](index=31&type=section&id=Liquidity%20and%20Capital%20Resources) The company, historically funded by grants and equity, raised **$397,607** from an ATM offering in Q1 2024, but faces significant future funding needs with existing capital projected only through **November 2024**, raising going concern doubts [Sources of Liquidity](index=31&type=section&id=Sources%20of%20Liquidity) Historically, the company funded operations through **$23.6 million** in grants and significant equity offerings, including **$14.6 million** (2020 IPO), **$41.1 million** (2021), **$8.5 million** (2023), and **$397,607** (Q1 2024 ATM) - From inception through March 31, 2024, the Company generated aggregate cash proceeds of approximately **$23.6 million** from private, state, and federal contracts and grants[123](index=123&type=chunk) - The Company raised approximately **$14.6 million** from its 2020 IPO, **$41.1 million** from its June 2021 Offering, and **$8.5 million** from its January 2023 Offering[123](index=123&type=chunk) - As of March 31, 2024, **290,564 ATM Shares** have been sold under the At The Market Offering, providing net proceeds of **$397,607**[124](index=124&type=chunk) [Future Funding Requirements](index=33&type=section&id=Future%20Funding%20Requirements) The company, with no product revenue and expected losses, requires substantial additional funding, planning to seek equity, debt, and grants, as current working capital is projected to fund operations only through **November 2024**, raising going concern doubts - The Company has not generated any revenue from the sale of commercial products and expects to incur significant losses for the foreseeable future[126](index=126&type=chunk) - Future funding is expected to come from equity offerings, debt financings, working capital lines of credit, grant funding, and potential licenses and collaboration agreements[127](index=127&type=chunk) - The Company had working capital of **$6,574,717** at March 31, 2024, and believes existing cash resources will fund operating requirements through **November 2024**[125](index=125&type=chunk)[132](index=132&type=chunk) - Conditions raise substantial doubt regarding the Company's ability to continue as a going concern for a period of one year after the financial statements are issued[131](index=131&type=chunk) [Cash Flows](index=35&type=section&id=Cash%20Flows) For Q1 2024, net cash used in operating activities was **$3.87 million**, investing activities used **$3.31 million**, and financing provided **$366,999**, resulting in a **$6.81 million net decrease** in cash | Cash Flow Activity | Three Months Ended March 31, 2024 ($) | Three Months Ended March 31, 2023 ($) | | :-------------------------------- | :-------------------------------- | :-------------------------------- | | Net cash used in operating activities | $(3,867,018) | $(5,972,130) | | Net cash used in investing activities | $(3,311,814) | $(5,838,842) | | Net cash provided by financing activities | $366,999 | $8,579,023 | | Net decrease in cash and cash equivalents | $(6,811,833) | $(3,231,949) | [Net Cash Flows Used in Operating Activities](index=35&type=section&id=Net%20Cash%20Flows%20Used%20in%20Operating%20Activities) Net cash used in operating activities decreased to **$3.87 million** in Q1 2024 from **$5.97 million** in Q1 2023, primarily due to a **$4.65 million net loss**, partially offset by non-cash adjustments and working capital changes - Net cash used in operating activities for Q1 2024 totaled **$3,867,018**, primarily from a net loss of **$4,649,635**[135](index=135&type=chunk) - Adjustments included non-cash stock compensation (**$53,434**), depreciation and lease expense (**$4,606**), and an increase in accounts payable (**$479,267**) and accrued expenses (**$247,634**)[135](index=135&type=chunk) - In Q1 2023, net cash used was **$5,972,130**, driven by a net loss of **$4,477,778** and significant decreases in prepaid expenses and accrued liabilities[136](index=136&type=chunk) [Cash Used in Investing Activities](index=37&type=section&id=Cash%20Used%20in%20Investing%20Activities) Net cash used in investing activities decreased to **$3.31 million** in Q1 2024 from **$5.84 million** in Q1 2023, due to **$8.43 million** in marketable securities purchases, partially offset by **$5.12 million** from maturities - Net cash used in investing activities for Q1 2024 totaled **$3.31 million**[137](index=137&type=chunk) - This included **$8.43 million** for purchases of marketable securities and **$5.12 million** from maturities of marketable securities[137](index=137&type=chunk) - In Q1 2023, net cash used was **$5.84 million**, with **$21.6 million** in purchases and **$15.8 million** in maturities[138](index=138&type=chunk) [Cash Provided by Financing Activities](index=37&type=section&id=Cash%20Provided%20by%20Financing%20Activities) Net cash provided by financing activities significantly decreased to **$366,999** in Q1 2024 from **$8.58 million** in Q1 2023, primarily reflecting net proceeds from the ATM Offering, offset by deferred offering costs - Net cash provided by financing activities for Q1 2024 totaled **$366,999**[139](index=139&type=chunk) - This consisted of net proceeds from the ATM Offering (**$397,607**) and deferred offering costs paid (**$30,608**)[139](index=139&type=chunk) - In Q1 2023, net cash provided was **$8,579,023**, primarily from the January 2023 Offering[140](index=140&type=chunk) [Off-Balance Sheet Arrangements](index=37&type=section&id=Off-Balance%20Sheet%20Arrangements) The company has not entered into any off-balance sheet arrangements - The Company has not entered into any off-balance sheet arrangements[141](index=141&type=chunk) [Contractual Obligations and Commitments](index=37&type=section&id=Contractual%20Obligations%20and%20Commitments) The company's primary contractual obligation is an operating lease for office space in Lexington, Massachusetts, through September 30, 2025, with total future minimum lease payments of **$227,803** - The Company has an operating lease agreement for office space in Lexington, Massachusetts, through September 30, 2025[142](index=142&type=chunk) - Total lease obligation is **$227,803**, with minimum annual rental obligations of **$112,837** for fiscal year 2024 and **$114,966** for fiscal year 2025[142](index=142&type=chunk) [Critical Accounting Policies and Significant Judgments and Estimates](index=37&type=section&id=Critical%20Accounting%20Policies%20and%20Significant%20Judgments%20and%20Estimates) Financial statement preparation requires significant judgments and estimates, particularly for research and development expenses, which are accrued based on estimated third-party services, with actual costs potentially differing from estimates [Research and Development Expenses](index=37&type=section&id=Research%20and%20Development%20Expenses) Research and development expenses are recorded as incurred, including employee costs and external service fees; the company makes significant judgments and estimates in accruing these, relying on timely provider reporting, with potential future adjustments - Research and development expenses are recorded as incurred and include employee-related expenses, external R&D expenses (CROs, clinical testing, CMOs), technology acquisition costs, and license fees[144](index=144&type=chunk) - The Company makes significant judgments and estimates in determining the accrued balance for R&D activities, particularly for third-party service providers[145](index=145&type=chunk)[146](index=146&type=chunk) - Accrued expenses are dependent on timely and accurate reporting from external providers, and estimates may be adjusted in the future[147](index=147&type=chunk) [Item 3. Quantitative and Qualitative Disclosures About Market Risk](index=40&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) As a smaller reporting company, Inhibikase Therapeutics, Inc. is not required to provide quantitative and qualitative disclosures about market risk - As a smaller reporting company, the Company is not required to provide disclosure regarding quantitative and qualitative market risk[148](index=148&type=chunk) [Item 4. Controls and Procedures](index=40&type=section&id=Item%204.%20Controls%20and%20Procedures) Management concluded the company's disclosure controls and procedures were effective at a reasonable assurance level as of March 31, 2024, with no material changes in internal control over financial reporting during the period - The Chief Executive Officer and Chief Financial Officer concluded that the Company's disclosure controls and procedures were effective at a reasonable assurance level as of March 31, 2024[149](index=149&type=chunk) - There was no change in internal control over financial reporting during the three months ended March 31, 2024, that materially affected, or is reasonably likely to materially affect, internal control over financial reporting[150](index=150&type=chunk) PART II. OTHER INFORMATION [Item 1. Legal Proceedings](index=41&type=section&id=Item%201.%20Legal%20Proceedings) On April 26, 2024, the company received an arbitration demand from Pivot Holding LLC for **$1.625 million** in alleged unpaid milestone payments, which the company intends to vigorously dispute - On April 26, 2024, the Company received a demand for arbitration from Pivot Holding LLC, alleging breach of contract for failure to pay **$1.625 million** in milestone payments[153](index=153&type=chunk) - The Company believes Pivot's claims are without merit and intends to vigorously dispute them[153](index=153&type=chunk) - The parties have agreed to mediate before arbitration, with the Company's response due by June 17, 2024[153](index=153&type=chunk) [Item 1A. Risk Factors](index=41&type=section&id=Item%201A.%20Risk%20Factors) As a smaller reporting company, the company is not required to provide a separate discussion of risk factors in this quarterly report - Risk Factors disclosure is not applicable as the Company is a smaller reporting company[154](index=154&type=chunk) [Item 2. Unregistered Sales of Equity Securities and Use of Proceeds](index=41&type=section&id=Item%202.%20Unregistered%20Sales%20of%20Equity%20Securities%20and%20Use%20of%20Proceeds) There were no unregistered sales of equity securities or use of proceeds to report for the period - No unregistered sales of equity securities and use of proceeds to report[155](index=155&type=chunk) [Item 3. Defaults Upon Senior Securities](index=41&type=section&id=Item%203.%20Defaults%20Upon%20Senior%20Securities) There were no defaults upon senior securities to report for the period - No defaults upon senior securities to report[156](index=156&type=chunk) [Item 4. Mine Safety Disclosures](index=41&type=section&id=Item%204.%20Mine%20Safety%20Disclosures) Mine safety disclosures are not applicable to the company's operations - Mine Safety Disclosures are not applicable[157](index=157&type=chunk) [Item 5. Other Information](index=41&type=section&id=Item%205.%20Other%20Information) There is no other information to report in this section - No other information to report[158](index=158&type=chunk) [Item 6. Exhibits](index=42&type=section&id=Item%206.%20Exhibits) This section lists all exhibits filed with the Form 10-Q, including organizational documents, warrant forms, securities purchase agreements, the ATM Agreement, and certifications - The section lists exhibits filed with the Form 10-Q, including Amended and Restated Certificate of Incorporation, Bylaws, various warrant forms, Securities Purchase Agreements, and the At The Market Offering Agreement[160](index=160&type=chunk) - It also includes certifications from the Principal Executive Officer and Principal Financial Officer pursuant to the Securities Exchange Act and Sarbanes-Oxley Act[160](index=160&type=chunk) [SIGNATURES](index=45&type=section&id=SIGNATURES) The report is duly signed on behalf of Inhibikase Therapeutics, Inc. by its Chief Executive Officer and Chief Financial Officer on May 15, 2024 - The report is signed by Milton H. Werner, Ph.D., Chief Executive Officer, and Garth Lees-Rolfe, Chief Financial Officer, on May 15, 2024[168](index=168&type=chunk)

BOSTON and ATLANTA, May 15, 2024 (GLOBE NEWSWIRE) -- Inhibikase Therapeutics, Inc. (NASDAQ:IKT) ("Inhibikase" or "Company"), a clinical-stage pharmaceutical company developing protein kinase inhibitor therapeutics to modify the course of Parkinson's disease, Parkinson's-related disorders and other diseases of the Abelson Tyrosine Kinases, today announced that it has filed a Request for Withdrawal with the U.S. Securities and Exchange Commission ("SEC") with respect to the withdrawal of the Company's Registr ...

- FDA indicated IkT-001Pro can be considered a New Molecular Entity and is eligible for exclusivity designations in Pulmonary Arterial Hypertension – BOSTON and ATLANTA, May 09, 2024 (GLOBE NEWSWIRE) -- Inhibikase Therapeutics, Inc. (NASDAQ:IKT) ("Inhibikase" or "Company"), a clinical-stage pharmaceutical company developing protein kinase inhibitor therapeutics to modify the course of Parkinson's disease, Parkinson's-related disorders and other diseases of the Abelson Tyrosine Kinases, today announced that ...

BOSTON and ATLANTA, April 18, 2024 (GLOBE NEWSWIRE) -- Inhibikase Therapeutics, Inc. (NASDAQ:IKT) (Inhibikase or Company), a clinical-stage pharmaceutical company developing protein kinase inhibitor therapeutics to modify the course of Parkinson's disease ("PD"), Parkinson's-related disorders and other diseases of the Abelson Tyrosine Kinases, today issued a Letter to Shareholders. Dear Fellow Shareholders of Inhibikase Therapeutics: 2024 has been off to a productive start for Inhibikase. Our 201 Trial is a ...

Commission File Number: 001-39676 UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-K ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 31, 2023 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 FOR THE TRANSITION PERIOD FROM TO INHIBIKASE THERAPEUTICS, INC. (Exact name of Registrant as specified in its Charter) Delaware 26-3407249 (State or other jurisdiction of ...