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 ...

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].