[First Quarter 2025 Earnings Release Overview](index=1&type=section&id=First%20Quarter%202025%20Earnings%20Release%20Overview) Inhibikase Therapeutics reported Q1 2025 results, highlighting IKT-001's advancement for PAH into a late-stage clinical trial program [Company Announcement and Strategic Focus](index=1&type=section&id=Company%20Announcement%20and%20Strategic%20Focus) Inhibikase reported Q1 2025 results, advancing IKT-001 for PAH into a late-stage clinical trial, targeting Phase 2b initiation in H2 2025 - Inhibikase Therapeutics is a clinical-stage pharmaceutical company focused on small molecule kinase inhibitor therapeutics to treat pulmonary arterial hypertension (PAH)[1](index=1&type=chunk) - The company is advancing IKT-001 into a late-stage clinical trial program in PAH[1](index=1&type=chunk) - The Phase 2b clinical study of IKT-001 in PAH is well placed to initiate in the **second half of 2025**[2](index=2&type=chunk) - IKT-001 is believed to provide strong efficacy and be well tolerated for PAH patients, building on previous IMPRES Phase 3 study results for imatinib mesylate[2](index=2&type=chunk) [Recent Corporate Developments](index=1&type=section&id=Recent%20Corporate%20Developments) Inhibikase announced key senior leadership appointments and refined the study design for the upcoming Phase 2b clinical study of IKT-001 in PAH - New senior leadership appointments include Mark Iwicki (CEO), Chris Cabell (President and Head of Research & Development), John Adams (Chief Scientific Officer), and David McIntyre (Chief Financial Officer)[8](index=8&type=chunk) - The company is refining the study design for the forthcoming Phase 2b clinical study of IKT-001 in PAH with key opinion leaders and expects to finalize it in the ensuing weeks[8](index=8&type=chunk) - A 'Study May Proceed' letter for the Phase 2b trial was received in **September 2024**, noting imatinib's prior demonstrated impact on key efficacy parameters in advanced PAH[8](index=8&type=chunk) [First Quarter 2025 Financial Results](index=1&type=section&id=First%20Quarter%202025%20Financial%20Results) Inhibikase reported a net loss of $13.7 million in Q1 2025, driven by increased R&D and SG&A expenses, with $93.2 million in cash [Key Financial Highlights](index=1&type=section&id=Key%20Financial%20Highlights) For Q1 2025, Inhibikase reported a net loss of $13.7 million, significantly higher than Q1 2024, primarily due to increased R&D and SG&A expenses | Metric | Q1 2025 (in millions) | Q1 2024 (in millions) | Change (YoY) (in millions) | | :-------------------------------- | :---------- | :---------- | :----------- | | Net Loss | $(13.7) | $(4.6) | $(9.1) | | Net Loss per Share | $(0.15) | $(0.73) | $(0.58) | | R&D Expenses | $10.5 | $2.8 | $7.7 | | SG&A Expenses | $5.2 | $2.0 | $3.2 | - R&D expenses for Q1 2025 included a non-cash charge for in-process research and development expense of **$7.4 million** associated with the Company's acquisition of CorHepta, effective **February 21, 2025**[5](index=5&type=chunk) - Cash, cash equivalents and marketable securities were **$93.2 million** as of **March 31, 2025**[7](index=7&type=chunk) [Consolidated Balance Sheets](index=3&type=section&id=Consolidated%20Balance%20Sheets) As of March 31, 2025, total assets decreased slightly to $94.3 million, while total current liabilities significantly increased to $8.6 million | Balance Sheet Item | March 31, 2025 (in dollars) | December 31, 2024 (in dollars) | Change (in dollars) | | :-------------------------------- | :--------------- | :---------------- | :------- | | Cash and cash equivalents | $73,441,391 | $56,490,579 | +$16,950,812 | | Marketable securities | $19,738,900 | $41,052,949 | -$21,314,049 | | Total current assets | $94,164,758 | $98,451,309 | -$4,286,551 | | Total assets | $94,281,322 | $98,599,846 | -$4,318,524 | | Accounts payable | $1,692,051 | $943,019 | +$749,032 | | Accrued expenses and other current liabilities | $3,513,248 | $2,680,030 | +$833,218 | | Contingent consideration liability | $3,270,579 | — | +$3,270,579 | | Total current liabilities | $8,550,650 | $3,733,566 | +$4,817,084 | | Total stockholders' equity | $85,730,672 | $94,866,280 | -$9,135,608 | - The increase in current liabilities was significantly impacted by the introduction of a **$3,270,579** contingent consideration liability[14](index=14&type=chunk) [Condensed Consolidated Statements of Operations and Comprehensive Loss](index=4&type=section&id=Condensed%20Consolidated%20Statements%20of%20Operations%20and%20Comprehensive%20Loss) Inhibikase reported a net loss of $13.7 million for Q1 2025, driven by substantial rises in R&D and SG&A expenses, with increased interest income | Income Statement Item | Q1 2025 (in dollars) | Q1 2024 (in dollars) | Change (YoY) (in dollars) | | :-------------------------------- | :---------- | :---------- | :----------- | | Research and development | $10,513,579 | $2,751,279 | +$7,762,300 | | Selling, general and administrative | $5,249,291 | $2,031,081 | +$3,218,210 | | Change in fair value contingent consideration | $(1,164,864) | — | $(1,164,864) | | Total costs and expenses | $14,598,006 | $4,782,360 | +$9,815,646 | | Loss from operations | $(14,598,006) | $(4,782,360) | $(9,815,646) | | Interest income | $919,271 | $132,725 | +$786,546 | | Net loss | $(13,678,735) | $(4,649,635) | $(9,029,100) | | Net loss per share – basic and diluted | $(0.15) | $(0.73) | +$0.58 (due to share count) | | Weighted-average number of shares – basic and diluted | 89,537,171 | 6,340,697 | +83,196,474 | - The significant increase in weighted-average shares outstanding (from **6,340,697** to **89,537,171**) impacted the net loss per share comparison, making the per-share loss appear smaller despite a larger total net loss[16](index=16&type=chunk) [Company Information and Disclosures](index=2&type=section&id=Company%20Information%20and%20Disclosures) This section provides details about Inhibikase Therapeutics, its social media disclosure policy, forward-looking statements, and investor contacts [About Inhibikase](index=2&type=section&id=About%20Inhibikase) Inhibikase Therapeutics, Inc. is a clinical-stage pharmaceutical company specializing in developing Abelson Tyrosine Kinase inhibitor therapeutics for Cardiopulmonary disease - Inhibikase Therapeutics, Inc. is a clinical-stage pharmaceutical company developing Abelson Tyrosine Kinase inhibitor therapeutics for Cardiopulmonary disease[9](index=9&type=chunk) - IKT-001, a prodrug of imatinib mesylate, leads Inhibikase's cardiopulmonary disease portfolio for PAH[9](index=9&type=chunk) [Social Media Disclaimer](index=2&type=section&id=Social%20Media%20Disclaimer) Inhibikase informs investors that material financial information is disclosed via its investor relations website, press releases, SEC filings, and public conference calls/webcasts - The Company announces material financial information to investors using its investor relations website, press releases, SEC filings and public conference calls and webcasts[10](index=10&type=chunk) - The Company intends to also use LinkedIn and YouTube as a means of disclosing information and for complying with its disclosure obligations under Regulation FD[10](index=10&type=chunk) [Forward-Looking Statements](index=2&type=section&id=Forward-Looking%20Statements) The press release contains forward-looking statements regarding future activities, subject to risks and uncertainties, with no obligation to update except as required by law - Forward-looking statements include statements related to the initiation of the Company's Phase 2b trial of IKT-001 in PAH and the Company's future activities, or future events or conditions; and expectations regarding the anticipated contribution of our new leadership team[11](index=11&type=chunk) - These forward-looking statements are based on current expectations and assumptions and are subject to certain risks and uncertainties, which could cause actual results to differ materially[11](index=11&type=chunk) - Inhibikase undertakes no obligation to publicly update or revise any forward-looking statement, except as may be required by any applicable securities laws[11](index=11&type=chunk) [Contacts](index=2&type=section&id=Contacts) Investor relations contact information is provided for Michael Moyer of LifeSci Advisors - Investor Relations contact: Michael Moyer, LifeSci Advisors, mmoyer@lifesciadvisors.com[12](index=12&type=chunk)

Core Viewpoint - Inhibikase Therapeutics is advancing its lead product IKT-001 into a late-stage clinical trial for pulmonary arterial hypertension (PAH), with plans to initiate a Phase 2b study in the second half of 2025, supported by a strengthened leadership team and refined study protocols [2][9]. Recent Developments - The company has appointed key executives, including Mark Iwicki as CEO and Chris Cabell as President and Head of Research & Development, to enhance its leadership team [9]. - Ongoing discussions with key opinion leaders are aimed at refining the study design for the upcoming Phase 2b clinical trial of IKT-001 [9]. - The company received a "Study May Proceed" letter for the Phase 2b trial in September 2024, indicating prior positive efficacy results from imatinib in PAH patients [9]. First Quarter 2025 Financial Results - The net loss for Q1 2025 was $13.7 million, or $0.15 per share, compared to a net loss of $4.6 million, or $0.73 per share in Q1 2024 [4][14]. - Research and development expenses increased to $10.5 million in Q1 2025 from $2.8 million in Q1 2024, including a non-cash charge of $7.4 million related to the acquisition of CorHepta [5]. - Selling, general and administrative expenses rose to $5.2 million in Q1 2025 from $2.0 million in Q1 2024 [6]. - As of March 31, 2025, the company had cash, cash equivalents, and marketable securities totaling $93.2 million [6]. Balance Sheet Highlights - Total current assets as of March 31, 2025, were $94.2 million, a decrease from $98.6 million as of December 31, 2024 [12][13]. - Total liabilities were reported at $8.6 million as of March 31, 2025, compared to $3.7 million at the end of 2024 [13]. - Stockholders' equity decreased to $85.7 million as of March 31, 2025, from $94.9 million at the end of 2024 [13].

Core Viewpoint - Purcell & Lefkowitz LLP is investigating Inhibikase Therapeutics, Inc. to determine if the company's directors breached their fiduciary duties related to recent corporate actions [1]. Group 1 - The investigation is being conducted on behalf of Inhibikase Therapeutics's shareholders [1]. - Shareholders interested in their rights and options can obtain additional information through Purcell & Lefkowitz LLP [2]. - The law firm specializes in representing shareholders affected by securities fraud and breaches of fiduciary duty [3].

Company Overview - Inhibikase Therapeutics, Inc. is a clinical-stage pharmaceutical company focused on developing small molecule kinase inhibitor therapeutics for pulmonary arterial hypertension (PAH) [4] - The company's lead product is IkT-001, a prodrug of imatinib mesylate, specifically targeting PAH [4] Leadership Appointment - David McIntyre has been appointed as Chief Financial Officer, effective April 14, 2025 [1] - McIntyre brings over two decades of executive experience in the life sciences sector, having held various C-suite roles in biotech and medical device companies [2] - His previous experience includes a nearly decade-long tenure as a Partner at Apple Tree Partners, a life sciences venture capital fund [2] Educational Background - McIntyre holds a Bachelor of Economics (Accounting) from the University of Sydney, a Bachelor of Laws from the University of Technology, Sydney, and an MBA from Duke University's Fuqua School of Business [3] - He is a Certified Practicing Accountant and is admitted as a legal practitioner in New South Wales and the High Court of Australia [3]

PART I [Business](index=5&type=section&id=Item%201.%20Business) Inhibikase Therapeutics, a clinical-stage pharmaceutical company, prioritizes IKT-001 for PAH, leveraging third-party manufacturing and recent financing - The company's primary focus is advancing its lead program **IKT-001**, a prodrug of imatinib mesylate, for the treatment of Pulmonary Arterial Hypertension (PAH)[14](index=14&type=chunk) - Development of risvodetinib (IkT-148009) for Parkinson's disease has been paused following the completion of the Phase 2 '201 Trial' in October 2024, allowing the company to allocate resources to the IKT-001 program[14](index=14&type=chunk)[32](index=32&type=chunk) - In February 2025, the company acquired CorHepta Pharmaceuticals, Inc. for **$15.0 million** in stock to expand its product pipeline and strengthen its scientific leadership[32](index=32&type=chunk) - The company secured approximately **$110 million** in gross proceeds from a private placement in October 2024 to finance the initiation of a Phase 2b trial for IKT-001 in PAH[20](index=20&type=chunk)[32](index=32&type=chunk) [Company Overview and Pipeline](index=5&type=section&id=Company%20Overview%20and%20Pipeline) This clinical-stage firm focuses on cardiopulmonary diseases with lead candidate IKT-001 for PAH, confirmed for the 505(b)(2) pathway - **IKT-001** is a prodrug of imatinib mesylate designed to improve oral absorption and reduce GI side effects, targeting the PAH market[14](index=14&type=chunk)[15](index=15&type=chunk) - A bioequivalence study completed in 2023 established dose relationships, with **300 mg of IKT-001** bioequivalent to **230 mg of imatinib mesylate**, and **500 mg** equivalent to **383 mg**[15](index=15&type=chunk) - The FDA confirmed the **505(b)(2) pathway** is appropriate for IKT-001 approval, viewing it as a New Molecular Entity (NME) for potential market exclusivity[16](index=16&type=chunk)[20](index=20&type=chunk) - The IND for a Phase 2b trial in PAH was cleared by the FDA on September 9, 2024, after studies showed neither IKT-001 nor imatinib inhibit the hERG ion channel[20](index=20&type=chunk) [Strategy and Management](index=7&type=section&id=Strategy%20and%20Management) The company aims for IKT-001 FDA approval in PAH, strengthening its leadership with new CEO Mark Iwicki and Chairman Amit Munshi - New leadership includes **Mark Iwicki as CEO** and **Amit Munshi as Chairman of the Board**, effective February 14, 2025, bringing extensive biopharmaceutical industry experience[24](index=24&type=chunk)[25](index=25&type=chunk)[27](index=27&type=chunk) - The leadership team was strengthened by the addition of **Dr. Chris Cabell** and **Dr. John Adams** from CorHepta, enhancing drug development and cardiovascular expertise[28](index=28&type=chunk)[29](index=29&type=chunk) [History, Financing, and Government Funding](index=9&type=section&id=History%2C%20Financing%2C%20and%20Government%20Funding) Founded in 2008, the company went public in 2020, securing over **$17 million** in federal grants and recent private placements totaling **$114 million** for IKT-001 Recent Financing Activities | Date | Event | Gross Proceeds | | :--- | :--- | :--- | | May 2024 | Registered direct offering | $4,000,000 | | Oct 2024 | Private placement | $110,000,000 | - The company received significant non-dilutive funding from U.S. federal sources, including **six NIH grants totaling $10,053,365** for RAMP™ and **two NIH grants totaling $2,286,778** for its prodrug platform[31](index=31&type=chunk)[33](index=33&type=chunk) - A Department of Defense (DoD) contract provided **$7,129,614** for Medical Counter Measures (MCMs), with inventions developed under federal funding subject to government 'march-in' rights[31](index=31&type=chunk)[34](index=34&type=chunk) [Material Agreements and Manufacturing](index=11&type=section&id=Material%20Agreements%20and%20Manufacturing) The company holds exclusive IKT-001 commercialization rights via an agreement with Pivot Holding LLC, paying **$0.5 million** upfront and **$4.4 million** upon FDA approval, while outsourcing all manufacturing to CMOs like WuXi AppTec - The Sphaera Agreement, now with Pivot Holding LLC, grants exclusive commercialization rights for IKT-001, with a September 2024 amendment stipulating a **$500,000 upfront payment**, a **$4.4 million** payment upon FDA approval, and a low single-digit royalty on net sales[35](index=35&type=chunk) - The company outsources all manufacturing, relying on third-party CMOs for preclinical and clinical drug supply without owning or operating its own facilities[41](index=41&type=chunk)[42](index=42&type=chunk) - Key manufacturing partners include STA Pharmaceutical US LLC and STA Pharmaceuticals Co., Ltd., both subsidiaries of China-based WuXi AppTec Co., Ltd., for cGMP manufacturing of active pharmaceutical ingredients[39](index=39&type=chunk)[42](index=42&type=chunk) [Competition and Intellectual Property](index=14&type=section&id=Competition%20and%20Intellectual%20Property) The company faces intense competition in the PAH market and relies on its IKT-001 patent portfolio, protected until **2033-2034** with potential extensions, while all federally funded compounds are subject to government march-in rights - Competitors in the PAH market include major pharmaceutical companies such as GlaxoSmithKline, Johnson & Johnson, United Therapeutics, Gilead Sciences, and Merck & Co[46](index=46&type=chunk) - The patent portfolio for IKT-001 includes issued U.S. patents expiring between **2033 and 2034**, with potential extensions until **2045** for new methods of use[21](index=21&type=chunk)[51](index=51&type=chunk) - The patent portfolio for the IkT-148x program includes seven issued U.S. patents expiring in **2036**, with potential extensions to **2045**[52](index=52&type=chunk) - All novel compounds developed with U.S. government funding are subject to federal march-in rights, granting the government certain non-exclusive license rights[50](index=50&type=chunk) [Government Regulation](index=17&type=section&id=Government%20Regulation) The company's products are subject to extensive FDA regulation, pursuing the **505(b)(2) pathway** for IKT-001 and potentially seeking Orphan Drug Designation for **seven years** of market exclusivity - The FDA drug approval process involves preclinical studies and a three-phase clinical trial process to establish safety and efficacy before an NDA submission[55](index=55&type=chunk)[56](index=56&type=chunk)[57](index=57&type=chunk)[66](index=66&type=chunk) - The company is pursuing the **505(b)(2) regulatory pathway** for IKT-001, allowing reliance on existing data from studies not conducted by the applicant, potentially expediting development[78](index=78&type=chunk) - The company may seek Orphan Drug Designation for products targeting rare diseases, which, if granted, provides **seven years** of market exclusivity upon approval[79](index=79&type=chunk)[80](index=80&type=chunk) - Post-approval, the company must adhere to continuous FDA regulation, including cGMP for manufacturing, record-keeping, advertising restrictions, and adverse event reporting[81](index=81&type=chunk)[83](index=83&type=chunk) [Risk Factors](index=33&type=section&id=Item%201A.%20Risk%20Factors) The company faces substantial risks from its limited operating history, dependence on IKT-001, need for capital, clinical trial uncertainties, third-party reliance, competition, and intellectual property protection - The company is a clinical-stage entity with a limited operating history, no approved products, and significant net losses (**$27.5 million** in 2024), making future success difficult to predict[125](index=125&type=chunk)[126](index=126&type=chunk)[147](index=147&type=chunk) - Future operations are highly dependent on raising additional capital to fund clinical trials and product development; failure to do so could threaten long-term viability[125](index=125&type=chunk)[129](index=129&type=chunk)[151](index=151&type=chunk) - The business is highly dependent on the success of its lead candidate, **IKT-001**, which requires significant further development and regulatory approval[125](index=125&type=chunk)[158](index=158&type=chunk) - The company relies on third-party contractors for manufacturing, including suppliers in China, and for conducting clinical trials, introducing risks related to supply chain, quality, and regulatory compliance[130](index=130&type=chunk)[292](index=292&type=chunk)[305](index=305&type=chunk) - Intellectual property protection is critical but uncertain, facing risks of patent challenges, failure to obtain patents, and government 'march-in' rights on federally funded technology[130](index=130&type=chunk)[309](index=309&type=chunk)[336](index=336&type=chunk) [Unresolved Staff Comments](index=131&type=section&id=Item%201B.%20Unresolved%20Staff%20Comments) The company reports that it has no unresolved staff comments from the SEC - None[410](index=410&type=chunk) [Cybersecurity](index=131&type=section&id=Item%201C.%20Cybersecurity) The company manages cybersecurity risk via an external IT vendor, employing a distributed data model and Board oversight, and has not experienced a material breach - The Board of Directors oversees the cybersecurity risk management program, reviewing mitigation plans and approving policies and budgets annually[413](index=413&type=chunk) - The company uses an external vendor for IT infrastructure management, employing a distributed data model to mitigate breach impact, with no single server storing all information[415](index=415&type=chunk)[416](index=416&type=chunk) - The company states that cybersecurity threats have not materially affected, and are not reasonably likely to materially affect, its business, operations, or financial condition[412](index=412&type=chunk) [Properties](index=133&type=section&id=Item%202.%20Properties) The company leases its corporate headquarters in Atlanta, Georgia, and additional office space in Lexington, Massachusetts, sufficient for its needs - The company leases office space in Atlanta, Georgia (corporate headquarters) and Lexington, Massachusetts[417](index=417&type=chunk) [Legal Proceedings](index=133&type=section&id=Item%203.%20Legal%20Proceedings) The company is not currently a party to any material litigation or legal proceedings - The company is not currently involved in any material legal proceedings[418](index=418&type=chunk) [Mine Safety Disclosures](index=133&type=section&id=Item%204.%20Mine%20Safety%20Disclosures) This item is not applicable to the company - Not applicable[419](index=419&type=chunk) PART II [Market for Registrant's Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities](index=134&type=section&id=Item%205.%20Market%20for%20Registrant%27s%20Common%20Equity%2C%20Related%20Stockholder%20Matters%20and%20Issuer%20Purchases%20of%20Equity%20Securities) The company's common stock trades on Nasdaq under "IKT" since December 2020, with no history or future plans for cash dividends - Common stock has been traded on the Nasdaq Capital Markets under the symbol **"IKT"** since December 23, 2020[421](index=421&type=chunk) - The company has never declared or paid cash dividends and does not anticipate doing so in the foreseeable future[423](index=423&type=chunk) [Reserved](index=134&type=section&id=Item%206.%20%5BReserved%5D) This item is reserved [Management's Discussion and Analysis of Financial Condition and Results of Operations](index=135&type=section&id=Item%207.%20Management%27s%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Net loss increased to **$27.5 million** in FY2024 due to higher R&D and SG&A expenses, but a **$110 million** private placement boosted liquidity to **$97.5 million**, sufficient for the next twelve months Results of Operations (FY2024 vs. FY2023) | Metric | 2024 ($) | 2023 ($) | Change ($) | Change (%) | | :--- | :--- | :--- | :--- | :--- | | Grant Revenue | $0 | $260,501 | ($260,501) | (100.0%) | | Research & Development | ($17,210,548) | ($13,618,348) | ($3,592,200) | 26.4% | | Selling, General & Admin | ($11,378,520) | ($6,731,945) | ($4,646,575) | 69.0% | | Loss from Operations | ($28,589,068) | ($20,089,792) | ($8,499,276) | (42.3%) | | Net Loss | ($27,519,886) | ($19,028,883) | ($8,491,003) | (44.6%) | - The increase in R&D expenses was primarily due to a **$4.5 million** increase in stock-based compensation and a **$1.7 million** increase in expenses for the PAH program[450](index=450&type=chunk) - The increase in SG&A expenses was mainly driven by a **$3.1 million** increase in stock-based compensation and a **$2.0 million** increase in legal, consulting, and compliance fees[451](index=451&type=chunk) - As of December 31, 2024, the company had **$97.5 million** in cash, cash equivalents, and marketable securities and an accumulated deficit of **$94.4 million**. Management believes current cash is sufficient to fund operations for at least the next twelve months[453](index=453&type=chunk)[454](index=454&type=chunk)[459](index=459&type=chunk) [Quantitative and Qualitative Disclosures About Market Risk](index=147&type=section&id=Item%207A.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) As a smaller reporting company, Inhibikase is not required to provide this disclosure - Disclosure is not required as the company qualifies as a smaller reporting company[479](index=479&type=chunk) [Financial Statements and Supplementary Data](index=147&type=section&id=Item%208.%20Financial%20Statements%20and%20Supplementary%20Data) Audited consolidated financial statements show total assets of **$98.6 million** in 2024, a net loss of **$27.5 million**, and increased cash from financing activities Consolidated Balance Sheet Data (as of Dec 31) | Account | 2024 ($) | 2023 ($) | | :--- | :--- | :--- | | **Assets** | | | | Cash and cash equivalents | $56,490,579 | $9,165,179 | | Marketable securities | $41,052,949 | $4,086,873 | | Total current assets | $98,451,309 | $14,211,048 | | Total assets | $98,599,846 | $14,506,647 | | **Liabilities & Equity** | | | | Total current liabilities | $3,733,566 | $3,438,601 | | Total liabilities | $3,733,566 | $3,528,725 | | Accumulated deficit | ($94,420,611) | ($66,900,725) | | Total stockholders' equity | $94,866,280 | $10,977,922 | Consolidated Statement of Operations Data (Year Ended Dec 31) | Account | 2024 ($) | 2023 ($) | | :--- | :--- | :--- | | Grant revenue | $0 | $260,501 | | Research and development | $17,210,548 | $13,618,348 | | Selling, general and administrative | $11,378,520 | $6,731,945 | | Loss from operations | ($28,589,068) | ($20,089,792) | | Net loss | ($27,519,886) | ($19,028,883) | | Net loss per share | ($1.16) | ($3.16) | Consolidated Statement of Cash Flows Data (Year Ended Dec 31) | Account | 2024 ($) | 2023 ($) | | :--- | :--- | :--- | | Net cash used in operating activities | ($19,148,067) | ($18,085,043) | | Net cash (used in) provided by investing activities | ($37,004,201) | $11,656,666 | | Net cash provided by financing activities | $103,477,668 | $8,405,003 | | Net increase in cash and cash equivalents | $47,325,400 | $1,976,626 | [Changes in and Disagreements with Accountants on Accounting and Financial Disclosure](index=147&type=section&id=Item%209.%20Changes%20in%20and%20Disagreements%20with%20Accountants%20on%20Accounting%20and%20Financial%20Disclosure) The company reports no changes in or disagreements with its accountants on accounting and financial disclosure - None[481](index=481&type=chunk) [Controls and Procedures](index=147&type=section&id=Item%209A.%20Controls%20and%20Procedures) Management concluded the company's disclosure controls and internal control over financial reporting were effective as of December 31, 2024, with no material changes reported - As of December 31, 2024, the principal executive and financial officers concluded the company's disclosure controls and procedures were effective[483](index=483&type=chunk) - Management concluded that as of December 31, 2024, the company's internal control over financial reporting was effective based on the COSO 2013 framework[484](index=484&type=chunk) - The annual report does not include an attestation report from the registered public accounting firm on internal controls, as the company is an emerging growth company under the JOBS Act[485](index=485&type=chunk) [Other Information](index=148&type=section&id=Item%209B.%20Other%20Information) No directors or officers adopted or terminated a Rule 10b5-1 trading plan during the fourth quarter of 2024 - No directors or officers adopted or terminated a Rule 10b5-1 trading plan during the fourth quarter of 2024[487](index=487&type=chunk) [Disclosure Regarding Foreign Jurisdictions that Prevent Inspections](index=148&type=section&id=Item%209C.%20Disclosure%20Regarding%20Foreign%20Jurisdictions%20that%20Prevent%20Inspections) This item is not applicable to the company - Not applicable[488](index=488&type=chunk) PART III [Directors, Executive Officers and Corporate Governance](index=149&type=section&id=Item%2010.%20Directors%2C%20Executive%20Officers%20and%20Corporate%20Governance) Information on directors, executive officers, and corporate governance will be provided in the definitive proxy statement for the 2025 Annual Meeting of Stockholders - Information is incorporated by reference from the definitive proxy statement for the 2025 Annual Meeting of Stockholders, to be filed within 120 days of the fiscal year-end[491](index=491&type=chunk) [Executive Compensation](index=149&type=section&id=Item%2011.%20Executive%20Compensation) Executive compensation information will be provided in the definitive proxy statement for the 2025 Annual Meeting of Stockholders - Information is incorporated by reference from the definitive proxy statement for the 2025 Annual Meeting of Stockholders[493](index=493&type=chunk) [Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters](index=149&type=section&id=Item%2012.%20Security%20Ownership%20of%20Certain%20Beneficial%20Owners%20and%20Management%20and%20Related%20Stockholder%20Matters) Security ownership information for beneficial owners and management will be provided in the definitive proxy statement for the 2025 Annual Meeting of Stockholders - Information is incorporated by reference from the definitive proxy statement for the 2025 Annual Meeting of Stockholders[494](index=494&type=chunk) [Certain Relationships and Related Transactions, and Director Independence](index=149&type=section&id=Item%2013.%20Certain%20Relationships%20and%20Related%20Transactions%2C%20and%20Director%20Independence) Information on certain relationships, related transactions, and director independence will be provided in the definitive proxy statement for the 2025 Annual Meeting of Stockholders - Information is incorporated by reference from the definitive proxy statement for the 2025 Annual Meeting of Stockholders[495](index=495&type=chunk) [Principal Accountant Fees and Services](index=149&type=section&id=Item%2014.%20Principal%20Accountant%20Fees%20and%20Services) Principal accountant fees and services information will be provided in the definitive proxy statement for the 2025 Annual Meeting of Stockholders - Information is incorporated by reference from the definitive proxy statement for the 2025 Annual Meeting of Stockholders[496](index=496&type=chunk) PART IV [Exhibits, Financial Statement Schedules](index=182&type=section&id=Item%2015.%20Exhibits%2C%20Financial%20Statement%20Schedules) This section indexes financial statements and exhibits filed with the Form 10-K, with schedules omitted due to non-applicability or inclusion elsewhere - This item lists the financial statements, which are indexed on page F-1, and provides an index of all exhibits filed with the report[628](index=628&type=chunk)[629](index=629&type=chunk) [Form 10-K Summary](index=188&type=section&id=Item%2016.%20Form%2010-K%20Summary) The company has not provided a summary for its Form 10-K - None[635](index=635&type=chunk)

Financial Performance - Net loss for the year ended December 31, 2024, was $27.5 million, or $1.16 per share, compared to a net loss of $19.1 million, or $3.16 per share in 2023[4] - Total assets increased to $98.6 million in 2024 from $14.5 million in 2023, reflecting a substantial growth in the company's financial position[14] - The company reported no grant revenue for 2024, compared to $260,501 in 2023, indicating a shift in revenue generation strategy[16] Expenses - Research and development expenses increased to $17.2 million in 2024 from $13.6 million in 2023, reflecting a growth of approximately 26.5%[4] - Selling, general and administrative expenses rose to $11.4 million in 2024, up from $6.7 million in 2023, marking an increase of approximately 70.1%[5] Funding and Capital - Cash, cash equivalents, and marketable securities totaled $97.5 million as of December 31, 2024, significantly up from $14.2 million in 2023[6] - The company closed a private placement with gross proceeds of approximately $110 million in October 2024, with potential total gross proceeds of up to $275 million if warrants are exercised[3] Clinical Development - The company received its Study May Proceed letter for the Phase 2b trial of IkT-001 in September 2024, indicating progress in clinical development[3] - The active ingredient in IkT-001, imatinib, has been previously shown to be disease-modifying for pulmonary arterial hypertension (PAH)[3] Management Changes - The company appointed Mark Iwicki as CEO and added Chris Cabell and John Adams to the management team to enhance its capabilities in the PAH space[2]

Core Viewpoint - Inhibikase Therapeutics, Inc. is advancing its clinical development of IkT-001 for pulmonary arterial hypertension (PAH) and has reported a net loss for 2024 while enhancing its management team to support growth [2][4][7]. Financial Results - The net loss for the year ended December 31, 2024, was $27.5 million, or $1.16 per share, compared to a net loss of $19.1 million, or $3.16 per share in 2023 [4][15]. - Research and development expenses increased to $17.2 million in 2024 from $13.6 million in 2023 [4][14]. - Selling, general and administrative expenses rose to $11.4 million in 2024 from $6.7 million in 2023 [5][14]. - As of December 31, 2024, the company had cash, cash equivalents, and marketable securities totaling $97.5 million [5]. Recent Developments - The company closed a private placement in October 2024, raising approximately $110 million to support the late-stage clinical trial of IkT-001, with potential total gross proceeds of up to $275 million if warrants are exercised [7]. - The company received a "Study May Proceed" letter for the Phase 2b trial of IkT-001 in September 2024, indicating progress in its clinical development [7]. - The management team was strengthened with the appointments of Chris Cabell and John Adams, who are expected to accelerate the development of IkT-001 [2][7].

Core Viewpoint - Inhibikase Therapeutics, Inc. (IKT) has experienced a downtrend, losing 15.4% over the past two weeks, but a hammer chart pattern suggests a potential trend reversal due to increased buying interest [1][2]. Technical Analysis - The hammer chart pattern indicates a possible bottom in the stock price, suggesting that selling pressure may be exhausting and that bulls are gaining control [2][4]. - A hammer pattern forms when there is a small candle body with a long lower wick, indicating that the stock opened lower, made a new low, but closed near its opening price, reflecting buying interest [3][4]. Fundamental Analysis - There has been a positive trend in earnings estimate revisions for IKT, with a 4% increase in the consensus EPS estimate over the last 30 days, indicating that analysts expect better earnings than previously predicted [6][7]. - IKT holds a Zacks Rank of 2 (Buy), placing it in the top 20% of over 4,000 ranked stocks, which typically outperform the market [8].

Core Insights - Inhibikase Therapeutics has appointed Chris Cabell, M.D. as President and Head of Research & Development, and John Adams, Ph.D. as Chief Scientific Officer, both with extensive experience in pulmonary arterial hypertension (PAH) [1][2] - The company aims to accelerate the development of IkT-001, an oral prodrug of imatinib mesylate, for the treatment of PAH, with plans to execute a Phase 2 clinical trial [2][6] - Vince Aurentz has joined the Board of Directors, bringing significant experience in corporate strategy and business development from his previous roles in the biopharmaceutical sector [2][5] Leadership Appointments - Chris Cabell, M.D. has a background as Chief Medical Officer at Arena Pharmaceuticals and Chief Executive Officer at CorHepta Pharmaceuticals, with a focus on cardiology and PAH [3] - John Adams, Ph.D. co-founded CorHepta and previously held senior positions at Iambic Therapeutics and Reneo Pharmaceuticals, specializing in research and translational science [4] - Vince Aurentz has held key leadership roles, including Executive Vice President at Arena Pharmaceuticals, contributing to corporate strategy and business development [5] Company Overview - Inhibikase Therapeutics, Inc. is a clinical-stage pharmaceutical company focused on developing Abelson Tyrosine Kinase inhibitor therapeutics for cardiopulmonary diseases [6] - The company's lead product, IkT-001, targets PAH and is positioned as a potential innovative therapeutic option for patients suffering from this condition [6]

Core Viewpoint - Inhibikase Therapeutics has appointed Mark Iwicki as the new CEO and Amit Munshi as the independent Chair of the Board, effective February 14, 2025, marking a significant leadership transition aimed at advancing the company's development in pulmonary arterial hypertension (PAH) treatments [2][4]. Leadership Changes - Mark Iwicki replaces Dr. Milton H. Werner as CEO, bringing over 30 years of biopharmaceutical experience, including previous roles at KALA BIO and Civitas Therapeutics [5]. - Amit Munshi takes over as Chair of the Board from Roberto Bellini, who will remain a director [2][4]. Strategic Focus - The new leadership team is positioned to drive Inhibikase forward, particularly in the development of IkT-001Pro, a treatment for PAH, which is currently advancing to a Phase 2b clinical trial [3][10]. - The company aims to leverage $110 million in proceeds from an October financing to support the clinical development of IkT-001Pro [3]. Product Development - IkT-001Pro is a prodrug of imatinib mesylate designed to improve patient experience and reduce side effects in the treatment of PAH [10]. - The leadership emphasizes the significant unmet needs in PAH management and the potential impact of IkT-001Pro on patient outcomes [3]. Inducement Awards - In connection with Iwicki's appointment, the company granted inducement awards including stock options for up to 6,168,148 shares, with vesting conditions tied to performance metrics [8][9].