UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, DC 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended September 30, 2023 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission File Number: 001-39676 INHIBIKASE THERAPEUTICS, INC. (Exact Name of Registrant as Specified in its Charter) ( State or other jurisdiction of i ...

Inhibikase Therapeutics, Inc. (NASDAQ:IKT) Q2 2023 Earnings Conference Call August 15, 2023 8:00 AM ET Company Participants Alex Lobo - Investor Relations Milton Werner - Chief Executive Officer Joe Frattaroli - Chief Financial Officer Conference Call Participants Ed White - H.C. Wainwright Operator Good morning. Welcome to the Inhibikase Therapeutics Second Quarter 2023 Financial Results Conference Call. [Operator Instructions] Please note, this event is being recorded. I would now like to turn the confere ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, DC 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended June 30, 2023 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission File Number: 001-39676 INHIBIKASE THERAPEUTICS, INC. (Exact Name of Registrant as Specified in its Charter) ( State or other jurisdiction of incorp ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, DC 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended March 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 Commission File Number: 001-39676 INHIBIKASE THERAPEUTICS, INC. (Exact Name of Registrant as Specified in its Charter) ( State or other jurisdiction of incor ...

Inhibikase Therapeutics, Inc. (NASDAQ:IKT) Q4 2022 Earnings Conference Call April 3, 2023 8:00 AM ET Company Participants Alex Lobo - Stern Investor Relations Milton Werner - President & Chief Executive Officer Joe Frattaroli - Chief Financial Officer Conference Call Participants Operator Good morning and welcome to the Inhibikase Fourth Quarter and Full Year 2022 Earnings Conference Call. [Operator Instructions] Please note, today's event is being recorded. I would now like to turn the conference over to A ...

Business Overview - The company is a clinical-stage drug development firm with no products approved for commercial sale, making it difficult to evaluate its current business and predict future success [179]. - The company has incurred significant net losses since inception and anticipates continued losses for the foreseeable future [179]. - The company has relied on grants and contracts for revenue, having not generated any revenue from product sales [182]. - The company has experienced negative operating cash flows since inception and will need to seek additional funding through equity or debt financings [194]. - The company has incurred net losses of $18,054,155 and $14,786,063 for the years ended December 31, 2022 and 2021, respectively, with an accumulated deficit of $47,871,842 as of December 31, 2022 [209]. - The company anticipates continuing to incur significant expenses and increasingly higher operating losses for the foreseeable future due to ongoing research and development activities [211]. - The company has no products approved for commercial sale and has never generated revenue from product sales, relying on grants and contracts for funding [197]. Clinical Development and Regulatory Challenges - The FDA lifted the clinical holds on the IkT-148009 programs for Parkinson's disease and Multiple System Atrophy (MSA), allowing the company to proceed with clinical trials [186]. - The company may face substantial delays in clinical trials, which could prevent or limit regulatory approval and commercialization of its product candidates [181]. - The company has commenced Phase II clinical trials for IkT-148009, but there is no assurance that any product candidates will receive regulatory approval necessary for commercialization [224]. - The success of clinical trials is uncertain, with potential failures at any stage of testing [253]. - Regulatory agencies may impose clinical holds, impacting trial progress and patient safety [250]. - The company may encounter difficulties in enrolling patients for clinical trials, affecting timely completion [249]. - Regulatory approval processes from the FDA, EMA, and other authorities are critical, and failure to meet manufacturing specifications could hinder commercialization efforts [269]. Financial and Market Risks - The company has received deficiency notices from Nasdaq regarding the minimum bid price requirement, which may necessitate a reverse stock split to maintain listing [188]. - The company plans to implement a reverse stock split to regain compliance with Nasdaq's minimum bid price requirement, which may not result in a permanent increase in stock price [189]. - The company is actively monitoring the impact of the ongoing war between Russia and Ukraine, which could materially affect its business and financial condition [203]. - The company may face challenges in obtaining adequate reimbursement for its product candidates from payors, which could impact market acceptance and revenue generation [205]. - The company acknowledges that adverse developments in the financial services industry could adversely affect its operations and liquidity [207]. - The company may face challenges in obtaining adequate reimbursement from government and private payors, impacting the demand for its products [277]. Research and Development Focus - The company is highly dependent on the success of its initial product candidates targeting neurodegenerative diseases, a field with limited success in drug development [181]. - The company has invested significant financial resources in research and development, particularly for its RAMP™ drug discovery program and prodrug technologies [210]. - The company’s strategy involves identifying and developing biomarkers and molecules that can effectively engage targets related to neurodegenerative diseases, but success is not guaranteed [242]. - All product candidates are in early stages of development and will need substantial investment, regulatory approval, and marketing efforts before generating any revenue from product sales [222]. Manufacturing and Supply Chain Risks - The company does not currently have manufacturing facilities and relies on third-party manufacturers, which poses risks related to supply availability and compliance with regulations [339]. - The company may incur substantial costs and delays in identifying and qualifying replacement manufacturers if current ones cannot perform [342]. - Dependence on third-party suppliers for key raw materials poses risks, including limited control over pricing and availability [346]. - Manufacturing complexities may lead to supply disruptions, affecting clinical trial and product availability [267]. Intellectual Property and Legal Risks - The company’s success heavily relies on obtaining and maintaining patent protection for its product candidates [352]. - The patent prosecution process is complex and costly, potentially hindering the ability to secure necessary patents [354]. - Legal challenges could result in the invalidation or unenforceability of issued patents, significantly impacting the company's business and financial condition [372]. - The company may face patent infringement lawsuits if it files a Section 505(b)(2) application referencing a product marketed by another manufacturer, potentially delaying approval by up to 30 months [292]. Market Acceptance and Competition - Market acceptance by physicians, patients, and payors is crucial for commercial success, and various factors could inhibit this acceptance [273]. - The company faces significant competition in the neurodegenerative disease market from major pharmaceutical firms [262]. - Competitors may enter the market with generic versions of approved products, leading to a decline in sales [280]. Regulatory Compliance and Risks - The company must ensure compliance with cGMP regulations, which involves continual review and inspections by regulatory authorities [303]. - Changes in regulatory requirements could increase costs and delay the approval process for product candidates [261]. - The company may face restrictions on marketing and promotional activities due to regulatory compliance requirements, impacting revenue generation [308].

Inhibikase Therapeutics, Inc. (NASDAQ:IKT) Q3 2022 Earnings Conference Call November 15, 2022 8:00 AM ET Company Participants Alex Lobo – Stern Investor Relations Milton Werner – President and Chief Executive Officer Conference Call Participants Operator Good day, and welcome to Inhibikase Therapeutics' Third Quarter 2022 Financial Results Conference Call. All participants are in listen-only mode. [Operator Instructions] Please note, this event is being recorded. I would now turn the conference over to Alex ...

OR UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, DC 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended September 30, 2022 ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission File Number: 001-39676 INHIBIKASE THERAPEUTICS, INC. (Exact Name of Registrant as Specified in its Charter) ( State or other jurisdiction of i ...

Pipeline and Programs - Inhibikase Therapeutics is developing a multi-therapeutic pipeline of kinase inhibitor therapeutics focused on neurodegeneration, oncology, and infectious diseases[3] - IkT-148009, a lead c-Abl inhibitor program, is in Phase 2a study for Parkinson's disease (PD) and related disorders[4] - IkT-001Pro, an oncology product, is a BCR-Abl inhibitor with a potentially improved safety profile for leukemias and gastrointestinal cancers, with an IND application submitted for Chronic Myeloid Leukemia[5] - The company has a robust patent portfolio with protection to 2033 for oncology and 2036 for neurodegeneration[5] Financial Highlights - The company received $20.8 million in peer-reviewed grants and contracts from NIH, DoD, the Michael J Fox Foundation, and the Georgia Research Alliance[6] - Inhibikase Therapeutics secured $63 million in gross proceeds from investor capital in 2021[6] - As of June 30, 2022, the company's total working capital was $29,773,286[41] - As of June 30, 2022, the company's cash holdings were $32,212,276[43] Market and Clinical Data - The U S Parkinson's disease market is large, with an estimated 930,000 to 1,200,000 patients[11] - By 2025, Parkinson's disease drug sales are expected to exceed $6 billion[11] - Phase 1 trial data for IkT-148009 showed dose-proportional clinical pharmacokinetics and no clinically significant adverse events in healthy subjects (N=88) and Parkinson's patients (N=13)[24] - In CML, Gleevec® and its generics have $330.5 million in net U S sales, with generic Gleevec® holding over 57% market share[33]

Inhibikase Therapeutics, Inc. (NASDAQ:IKT) Q2 2022 Earnings Conference Call August 15, 2022 8:00 AM ET CompanyParticipants Milton Werner - CEO Joseph Frattaroli - CFO Alex Lobo - Stern IR Conference Call Participants Danya Ben-Hail - JonesTrading Operator Good day, and welcome to Inhibikase Therapeutics’ Second Quarter 2022 Financial Results Conference Call. All participants are in listen-only mode. [Operator Instructions] Please note, this event is being recorded. I would now turn the conference over to Al ...