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].

Core Insights - Inhibikase Therapeutics has secured transformative financing of up to $275 million to advance its drug IkT-001Pro into late-stage clinical trials for Pulmonary Arterial Hypertension (PAH) [1][3] - The company aims to improve the safety and tolerability profile of imatinib, which has previously faced approval challenges for PAH treatment [2][3] - Upcoming milestones include the reporting of 201 Trial results in Q4 2024, which evaluates risvodetinib in untreated Parkinson's disease [1][3] Financing and Investment - The financing includes a private placement of approximately $110 million, with potential aggregate financing of up to $275 million upon full cash exercise of accompanying warrants [3] - The funds will support the execution of the Phase 2b '702' trial in PAH and general corporate purposes [3] - Notable additions to the Board of Directors include experienced leaders from biopharmaceutical development, enhancing the company's strategic capabilities [3] Clinical Development - IkT-001Pro has received a Study May Proceed letter from the FDA, allowing the company to advance its clinical development [3] - The active ingredient, imatinib, is believed to have disease-modifying potential for PAH, with IkT-001Pro expected to offer a better safety profile [3] - The company is enhancing its manufacturing processes to support late-stage clinical development, including new dosage forms and efficient production methods [3] Financial Performance - For Q3 2024, the company reported a net loss of $5.8 million, or $0.65 per share, compared to a net loss of $4.6 million, or $0.75 per share in Q3 2023 [4][10] - Research and development expenses increased to $4.2 million in Q3 2024 from $3.23 million in Q3 2023 [4][10] - Selling, general and administrative expenses remained relatively stable at $1.6 million compared to $1.62 million in the same quarter of the previous year [5][10] Cash Position - As of September 30, 2024, the company had cash, cash equivalents, and marketable securities totaling $3.2 million, excluding the gross proceeds from the recent financing [5]

IkT-001Pro Development and Clinical Trials - The company completed a bioequivalence clinical trial for IkT-001Pro in 2023, establishing bioequivalence to 400 mg imatinib mesylate with a 600 mg dose of IkT-001Pro[78] - A dose between 800 mg and 900 mg of IkT-001Pro is preferred to deliver a dose equivalent to 600 mg imatinib mesylate[78] - The FDA acknowledged the 505(b)(2) pathway as appropriate for IkT-001Pro approval, pending formal review of clinical data[78] - IkT-001Pro and imatinib mesylate exhibit similar behavior toward gut transporters P-glycoprotein (PGP) and Breast Cancer Resistance Protein (BCRP)[79] - The company discussed alternate dosage forms for IkT-001Pro to prevent medication errors with imatinib mesylate[79] - The company met with the FDA Hematological Malignancy Review Team on January 19, 2024, to discuss IkT-001Pro's path to approval[78] - The company's multi-therapeutic pipeline includes IkT-001Pro for Pulmonary Arterial Hypertension (PAH)[77] - The company has patent protection in the United States until 2033 for IkT-001Pro[87] Risvodetinib Development and Clinical Trials - The company initiated Phase 2 201 trial for risvodetinib (IkT-148009) as a treatment for Parkinson's disease, with results expected in Q4 2024[77] - The company completed the Phase 2 201 trial for risvodetinib on October 6, 2024[77] - The Phase 2 '201 Trial' for risvodetinib in untreated Parkinson's disease was completed on October 6, 2024, with outcomes expected in Q4 2024[81] - The Company received a $0.39 million grant from the National Institute of Neurological Diseases and Stroke for risvodetinib studies in MSA[82] - The tablet formulation of risvodetinib nearly doubles the concentration delivered, potentially improving safety and tolerability[84] - The company's multi-therapeutic pipeline includes risvodetinib for Parkinson's disease[77] - The Company plans to submit regulatory documents for risvodetinib to European Union authorities in 2024 or 2025[82] - The company has patent protection in the United States until 2036 for risvodetinib[87] Financial Performance and Expenses - The Company closed a private placement with an initial investment of approximately $110 million, potentially reaching up to $275 million if warrants are exercised[80] - Research and development expenses for PAH increased by $814,424 in 2024 compared to 2023[95] - Total research and development expenses for the three months ended September 30, 2024, were $4,189,873, a 29.9% increase from 2023[100] - The Company's net loss for the three months ended September 30, 2024, was $5,778,066, a 25.7% increase from 2023[100] - Grant revenue for the three months ended September 30, 2024, decreased by $79,569 or 100.0% to $0 from $79,569 in the prior comparable period[101] - Research and development expenses increased by $964,322 or 29.9% to $4,189,873 from $3,225,551 in the prior comparable period[102] - Selling, general and administrative expenses increased by $14,709 or 0.9% to $1,637,603 from $1,622,894 in the prior comparable period[103] - Interest income decreased by $124,267 or 71.6% to $49,410 from $173,677 in the prior comparable period[104] - Grant revenue for the nine months ended September 30, 2024, decreased by $260,500 or 100% to $0 from $260,500 in the prior comparable period[106] - Research and development expenses decreased by $598,386 or 5.6% to $10,016,982 from $10,615,368 in the prior comparable period[107] - Selling, general and administrative expenses increased by $312,028 or 5.9% to $5,643,386 from $5,331,358 in the prior comparable period[108] - Interest income decreased by $562,224 or 67.3% to $273,059 from $835,283 in the prior comparable period[109] - The Company raised approximately $110 million in gross proceeds from its October 2024 Offering[110] - Net cash flows used in operating activities for the nine months ended September 30, 2024, totaled $13,802,492[117] - Net cash flows provided by financing activities for the nine months ended September 30, 2024, totaled $3.793 billion, consisting of $3.8 million from the issuance of common stock and pre-funded warrants[121] - Net cash flows provided by financing activities for the nine months ended September 30, 2023, totaled $8.543 billion, primarily from the issuance of common stock and pre-funded warrants[122] Market and Industry Insights - The global PAH market size was valued at $7.66 billion in 2023 and is estimated to grow at a CAGR of 5.4% between 2024 to 2030[80] - The company's clinical trials and product development are focused on neurodegenerative and cardiopulmonary diseases[77] Operational and Financial Details - The company's total lease obligation for its Lexington office space is $153,288, with minimum annual rental obligations of $38,322 for fiscal year 2024 and $114,966 for fiscal year 2025[123] - Research and development expenses include costs for employee-related expenses, external R&D arrangements, technology acquisition, and other direct and allocated expenses[125] - A significant portion of R&D expenses is attributed to external costs, including clinical studies, preclinical studies, and consulting services[126] - The company accrues and estimates R&D expenses based on costs incurred, with adjustments made as actual costs become known[127] - The company does not have any off-balance sheet arrangements[123] - Financial statements are prepared in accordance with US GAAP, requiring significant estimates and judgments that may impact reported amounts[124] - The company is not required to provide quantitative and qualitative market risk disclosures as a smaller reporting company[129]

Core Insights - Inhibikase Therapeutics has successfully closed a private placement raising approximately $110 million, with potential total financing of up to $275 million through warrants, aimed at funding the Phase 2b trial for IkT-001Pro in Pulmonary Arterial Hypertension (PAH) and general corporate purposes [1][2] Company Overview - Inhibikase Therapeutics is a clinical-stage pharmaceutical company focused on developing protein kinase inhibitor therapeutics targeting cardiopulmonary and neurodegenerative diseases through Abelson Tyrosine Kinase inhibition [1][10] - The company’s lead product, IkT-001Pro, is a prodrug formulation of imatinib mesylate, designed to improve the safety profile of imatinib, which is used for various cancers and has shown potential benefits in PAH [7][10] Financial Highlights - The private placement financing will support the execution of the Phase 2b '702' trial for IkT-001Pro and other corporate needs [1][2] - The financing is considered transformational, reflecting the confidence of top-tier healthcare investment funds in the potential of IkT-001Pro to improve patient outcomes in PAH [2] Leadership Changes - Concurrent with the financing, Inhibikase appointed several experienced leaders in biopharmaceutical development to its Board of Directors, including Roberto Bellini, Amit Munshi, Arvind Kush, and David Canner [2][3] - Roberto Bellini has been appointed as the Independent Chairperson of the Board, bringing extensive experience from his previous role as CEO of BELLUS Health [3][4] Product Development - IkT-001Pro has shown in preclinical studies to be up to 3.4 times safer and better tolerated than imatinib, potentially reducing gastrointestinal and other side effects associated with oral administration [7] - The FDA has cleared the 702 trial for clinical entry at Phase 2b, and IkT-001Pro has received Orphan Drug Designation for Stable-Phase CML, with a similar designation currently under review for PAH [7]

Core Viewpoint - Inhibikase Therapeutics, Inc. has announced a private placement financing of approximately $110 million to support the initiation of a Phase 2b trial in pulmonary arterial hypertension and for general corporate purposes [1][5]. Group 1: Financing Details - The private placement is led by Soleus Capital and includes participation from several new investors such as Sands Capital, Fairmount, and Blackstone Multi-Asset Investing [2]. - The company is selling a total of 58,310,000 shares of common stock and pre-funded warrants to purchase up to 21,985,000 shares, along with Series A-1 and Series B-1 warrants [4]. - The purchase price for each share of common stock and accompanying warrants is set at $1.37, while the pre-funded warrants are priced at $1.369 [4]. Group 2: Board Changes - Two current board members, Ms. Gisele Dion and Dr. Paul Grint, will resign, and four new directors will join the board, including Roberto Bellini and Amit Munshi [3]. - Roberto Bellini will serve as the Independent Chairperson of the Board of Directors [3]. Group 3: Company Overview - Inhibikase Therapeutics is a clinical-stage pharmaceutical company focused on developing Abelson Tyrosine Kinase inhibitor therapeutics for cardiopulmonary and neurodegenerative diseases [9]. - The company's pipeline includes IkT-001Pro for pulmonary arterial hypertension and risvodetinib for neurodegenerative diseases such as Parkinson's disease [9].

Financial Data and Key Metrics Changes - The net loss for Q2 2024 was $5.0 million or $0.66 per share, compared to a net loss of $5.8 million or $0.94 per share for Q2 2023, indicating an improvement in financial performance [12] - Research and development expenses decreased to $3.1 million from $4.5 million in the same period last year, primarily due to reduced expenses related to IkT-001Pro [13] - Selling, general and administrative expenses increased to $2.0 million from $1.8 million, driven by higher legal and consulting fees [13] - As of June 30, 2024, the company had $7.9 million in cash, cash equivalents, and marketable securities, expected to fund operations into December 2024 [14] Business Line Data and Key Metrics Changes - The company completed enrollment for its Phase 2 201 trial for risvodetinib in Parkinson's disease, with top-line data expected in November 2024 [5][7] - Significant progress was made in the development of IkT-001Pro for pulmonary arterial hypertension (PAH), with an IND filed on August 9, 2024 [9][12] Market Data and Key Metrics Changes - The global market for pulmonary arterial hypertension is valued at $7.7 billion annually, presenting a significant opportunity for IkT-001Pro [8] Company Strategy and Development Direction - The company aims to differentiate its pipeline of neurological and cardiopulmonary assets, with multiple near-term milestones expected in the second half of 2024 [15] - The strategy includes advancing risvodetinib as a potential disease-modifying treatment for Parkinson's disease and IkT-001Pro for PAH, leveraging FDA discussions to align on trial designs [9][18] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the clinical progress made in the first half of 2024 and the potential for upcoming data to support further development [4][15] - The company is optimistic about the safety and tolerability of risvodetinib, with expectations for a robust Phase 3 trial following the upcoming data release [21] Other Important Information - The company is exploring alternative financing opportunities for its Multiple System Atrophy program and developing new antibody diagnostic tools for Parkinson's disease [10][11] Q&A Session Summary Question: Update on the risvo Phase 2 study and open-label extension - Management confirmed that 89 patients have completed the trial, with plans to launch the open-label extension study soon, despite some patients potentially opting for symptomatic treatment [16] Question: Details on the Phase 3 program for risvodetinib - Management indicated that the Phase 3 program would likely involve 300 to 400 patients across two trials, focusing on untreated Parkinson's disease [20] Question: Expectations for IND clearance for IkT-001Pro - Management expects IND clearance to proceed without major gating factors, with trial initiation anticipated in approximately 9 to 12 months [22]

Core Viewpoint - Inhibikase Therapeutics, Inc. has reported its financial results for Q2 2024, highlighting advancements in its clinical pipeline, particularly for risvodetinib and IkT-001Pro, while also showing a reduction in net loss compared to the previous year [1][4]. Recent Developments and Upcoming Milestones - The company completed enrollment in the Phase 2 '201' trial for risvodetinib, with 126 patients enrolled and the last patient expected to exit the trial in September 2024, with topline data anticipated in November 2024 [2][3]. - IkT-001Pro has progressed as a potential treatment for Pulmonary Arterial Hypertension (PAH), with an IND filed and plans to ramp up the Phase 2 '702' trial following FDA clearance [2][3]. - The FDA acknowledged the company's bridging study between imatinib's use in cancers and PAH, deeming the Phase 2 design reasonable [3]. - The active ingredient in IkT-001Pro, imatinib, has shown potential as a disease-modifying agent for PAH, with a market value of $7.66 billion in 2023 for this indication [3]. - The company successfully raised $4 million in May 2024 to support the advancement of risvodetinib and IkT-001Pro [3]. Financial Results - The net loss for Q2 2024 was $5.0 million, or $0.66 per share, an improvement from a net loss of $5.8 million, or $0.94 per share in Q2 2023 [4]. - Research and development expenses decreased to $3.1 million in Q2 2024 from $4.5 million in Q2 2023, primarily due to the completion of a dose-finding study [5]. - Selling, general and administrative expenses increased to $2.0 million in Q2 2024 from $1.8 million in Q2 2023, driven by higher legal and consulting fees [6]. - As of June 30, 2024, the company had cash, cash equivalents, and marketable securities totaling $7.9 million, expected to fund operations into December 2024 [7].

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, 2024 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) Delaware 26-3407249 ( State or other ju ...

BOSTON and ATLANTA, Aug. 07, 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 will report financial results for the second quarter ended June 30, 2024, on Wednesday, August 14, 2024, after the close of U.S. markets. Followi ...

BOSTON and ATLANTA, Aug. 07, 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 will report financial results for the second quarter ended June 30, 2024, on Wednesday, August 14, 2024, after the close of U.S. markets. Followi ...