Inhibikase Therapeutics(IKT)
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Inhibikase Therapeutics(IKT) - 2025 Q4 - Annual Report
2026-03-26 20:32
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Commission File Number: 001-39676 INHIBIKASE THERAPEUTICS, INC. (Exact name of Registrant as specified in its Charter) Delaware 26-3407249 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, 2025 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 FOR THE TRANSITION PERIOD FROM TO Registrant's telephone number, i ...
Inhibikase Therapeutics(IKT) - 2025 Q4 - Annual Results
2026-03-26 20:21
Exhibit 99.1 Inhibikase Therapeutics Announces Full Year 2025 Financial Results and Highlights Recent Activity WILMINGTON, Del., March 26, 2026 — Inhibikase Therapeutics, Inc. (Nasdaq: IKT) ("Inhibikase" or "Company"), a clinical-stage pharmaceutical company developing therapeutics to modify the course of cardiopulmonary diseases namely, Pulmonary Arterial Hypertension ("PAH"), today reported financial results for the year ended December 31, 2025 and highlighted recent developments. "The fourth quarter of 2 ...
Inhibikase Therapeutics Announces Full Year 2025 Financial Results and Highlights Recent Activity
Globenewswire· 2026-03-26 20:01
WILMINGTON, Del., March 26, 2026 (GLOBE NEWSWIRE) -- Inhibikase Therapeutics, Inc. (Nasdaq: IKT) (“Inhibikase” or “Company”), a clinical-stage pharmaceutical company developing therapeutics to modify the course of cardiopulmonary diseases namely, Pulmonary Arterial Hypertension (“PAH”), today reported financial results for the year ended December 31, 2025 and highlighted recent developments. “The fourth quarter of 2025 was a transformational quarter for the Company as we transitioned to a global pivotal Pha ...
Bank of America Predicts Up to 240% Jump for These 2 ‘Strong Buy’ Stocks
Yahoo Finance· 2026-02-22 11:15
Industry Overview - Pulmonary arterial hypertension (PAH) is a rare but significant condition, with the global market valued at $8.29 billion in 2024 and projected to reach nearly $12 billion by 2030 due to increasing demand for novel therapies [1] - The Nasdaq Biotechnology Index has increased by 30% over the past year, outperforming the S&P 500, as investors shift focus from high-valued tech stocks to biotech, which offers more compelling valuations and tangible catalysts [5] Company: Inhibikase Therapeutics - Inhibikase Therapeutics is a small-cap biotech focused on kinase biology, with its lead candidate IKT-001 targeting PAH, aiming to modify the disease rather than just manage symptoms [2][6] - IKT-001 is an oral prodrug of imatinib, designed to improve tolerability while retaining efficacy in PAH treatment [6] - Phase 1 study results showed IKT-001 was well tolerated, with pharmacokinetic data supporting its advancement into trials with PAH patients [7] - The company received FDA clearance to bypass a planned Phase 2b trial and move directly into a pivotal Phase 3 program, IMPROVE-PAH, which will enroll up to 486 patients across 180 global sites [8] - Bank of America analyst Jason Zemansky believes IKT's current share price of $1.76 presents an attractive entry point, with a price target of $6 indicating a potential upside of 240% [9][11] - The analyst highlights the potential for IKT-001 to reshape the treatment paradigm in PAH, with a favorable risk/reward profile [10] Company: Wave Life Sciences - Wave Life Sciences is an RNA-focused biotech advancing drug candidates through its proprietary PRISM platform, targeting genetically driven diseases [11][12] - The company is developing WVE-007, which has shown significant reductions in visceral fat and total body fat in early trials for obesity, with plans for further studies [13] - WVE-006 is designed to correct the SERPINA1 Z allele mutation causing alpha-1 antitrypsin deficiency, currently in Phase 1b/2a trials with favorable safety data [14] - Analyst Alec Stranahan rates WVE shares a Buy, with a price target of $38, suggesting a potential upside of 182% [17] - The broader analyst community also supports WVE, with a Strong Buy consensus based on 15 positive reviews, indicating a potential upside of 141% [17]
Inhibikase Therapeutics Announces Pricing of $100 Million Public Offering of Common Stock and Pre-Funded Warrants
Globenewswire· 2025-11-21 02:54
Core Viewpoint - Inhibikase Therapeutics, Inc. has announced a public offering of common stock and pre-funded warrants to raise approximately $100 million to support its development of therapeutics for pulmonary arterial hypertension (PAH) [1][5] Group 1: Offering Details - The company is offering 46,091,739 shares of common stock at a price of $1.45 per share and pre-funded warrants at $1.449 each, with a total expected gross proceeds of around $100 million before expenses [1] - An additional 10,344,827 shares may be purchased by underwriters within 30 days at the public offering price [1] - The offering is expected to close on November 24, 2025, subject to customary closing conditions [1] Group 2: Underwriters - Jefferies, BofA Securities, and Cantor are acting as joint book-running managers for the offering [2] - LifeSci Capital and Oppenheimer & Co. are co-lead managers, while H.C. Wainwright & Co. and Ladenburg Thalmann & Co. Inc. are co-managers [2] Group 3: Company Overview - Inhibikase Therapeutics is focused on developing therapeutics for cardiopulmonary diseases, particularly PAH, which affects approximately 50,000 Americans [5] - The lead product candidate is IKT-001, a prodrug of imatinib mesylate, targeting the underlying mechanisms of PAH [5]
Inhibikase Therapeutics Announces Proposed Public Offering of Common Stock and Pre-Funded Warrants
Globenewswire· 2025-11-20 21:12
Core Viewpoint - Inhibikase Therapeutics, Inc. has initiated an underwritten public offering of its common stock and pre-funded warrants, aiming to raise capital for its development of therapeutics for pulmonary arterial hypertension (PAH) [1][2]. Company Overview - Inhibikase Therapeutics is a clinical-stage pharmaceutical company focused on developing treatments for cardiopulmonary diseases, specifically PAH, which affects approximately 50,000 Americans [5]. - The lead product candidate is IKT-001, a prodrug of imatinib mesylate, targeting the underlying mechanisms of PAH [5]. Offering Details - The company is offering shares of common stock and pre-funded warrants, with a 30-day option for underwriters to purchase an additional 15% of the total shares at the public offering price [1]. - The offering is subject to market conditions, and there is no assurance regarding its completion or the final terms [1][3]. Underwriters - Jefferies, BofA Securities, and Cantor are the joint book-running managers for the offering, with LifeSci Capital and Oppenheimer & Co. as co-lead managers [2].
Inhibikase Therapeutics Advancing IKT-001 to Global Phase 3 Study in Pulmonary Arterial Hypertension
Globenewswire· 2025-11-20 21:01
Core Insights - Inhibikase Therapeutics is advancing its investigational drug IKT-001 into a pivotal Phase 3 clinical study for Pulmonary Arterial Hypertension (PAH), expected to start in Q1 2026, which could accelerate the FDA approval timeline by approximately three years [2][6]. Company Overview - Inhibikase Therapeutics, Inc. is a clinical-stage pharmaceutical company focused on developing therapeutics for cardiopulmonary diseases, particularly PAH, which affects around 50,000 Americans [7]. Drug Development Details - IKT-001 is a novel pro-drug of imatinib mesylate, designed to improve pulmonary vascular resistance (PVR) and 6-minute walk distance (6MWD) by 45 meters based on previous studies [3][11]. - The company has shifted from a planned Phase 2b study to a two-part adaptive Phase 3 study, with Part A focusing on PVR and Part B on 6MWD, involving a total of approximately 486 patients [5][6]. Study Design and Expectations - The adaptive Phase 3 study design includes a 12-week dose-titration phase to optimize dosing, uninterrupted enrollment between study parts, and potential sample size adjustments based on initial findings [5][6]. - The company anticipates that the new study plan will enhance the probability of success due to improved gastrointestinal tolerability and extensive clinical experience with imatinib [6].
Inhibikase Therapeutics(IKT) - 2025 Q3 - Quarterly Report
2025-11-14 21:37
Market Overview - The global Pulmonary Arterial Hypertension (PAH) market was valued at $7.66 billion in 2023, with an estimated compound annual growth rate of 3.3% through 2034[128]. - Sotatercept, launched in 2024, is generating approximately $1.4 billion in annualized sales, indicating a growing interest in anti-proliferative therapies for PAH[129]. Product Development - IKT-001, a prodrug of imatinib mesylate, is set to enter a Phase 2b study involving approximately 150 PAH patients, expected to initiate in Q4 2025[124][135]. - The FDA acknowledged the 505(b)(2) pathway as appropriate for IKT-001's approval, with a pre-NDA meeting confirming no additional clinical studies are needed[127]. - IKT-001 has established bioequivalence with a 300 mg dose to 230 mg of imatinib mesylate, and a 500 mg dose to 383 mg of imatinib mesylate, based on a study completed in 2023[126]. - The primary efficacy endpoint for the IMPROVE-PAH study will be the change in pulmonary vascular resistance (PVR) at Week 26[135]. - The company plans to apply for Orphan Drug Designation for IKT-001 once pre-clinical studies are complete, enhancing its market exclusivity prospects[133]. Financial Performance - Research and development expenses increased by $3,459,824 or 82.6% to $7,649,697 for the three months ended September 30, 2025, compared to $4,189,873 in the prior year[151]. - Selling, general and administrative expenses rose by $3,973,900 or 242.7% to $5,611,503 for the same period, up from $1,637,603[152]. - Net loss for the three months ended September 30, 2025, was $11,930,280, representing an increase of $6,152,214 or 106.5% from the previous year[150]. - Research and development expenses for the nine months ended September 30, 2025, totaled $23,434,243, an increase of $13,417,261 or 133.9% from $10,016,982 in 2024[157]. - Selling, general and administrative expenses for the nine months ended September 30, 2025, increased by $11,137,139 or 197.3% to $16,780,525 from $5,643,386[158]. - Interest income surged by $2,401,060 or 879.3% to $2,674,119 for the nine months ended September 30, 2025, compared to $273,059 in the prior year[160]. - The company had cash, cash equivalents, and marketable securities of $77.3 million as of September 30, 2025[163]. - The accumulated deficit reached $129.9 million as of September 30, 2025, with expectations of continued significant losses in the future[167]. - The company anticipates needing substantial additional funding to support ongoing operations and product development[165]. - The company has not generated any revenue from product sales and does not expect to do so until regulatory approval is obtained for its product candidates[165]. Cash Flow and Financing - Net cash used in operating activities for the nine months ended September 30, 2025, totaled $20,270,491, compared to $13,802,492 for the same period in 2024, reflecting a significant increase in cash outflow[172][174]. - Net cash provided by investing activities for the nine months ended September 30, 2025, was $2,151,977, up from $1,757,524 in 2024, primarily due to $41.6 million from the maturity of marketable securities[175][176]. - Net cash used in financing activities for the nine months ended September 30, 2025, was $102,359, a decrease from $3,793,209 in 2024, indicating reduced financing activity[177][178]. Merger and Acquisition - The company entered into a merger agreement with CorHepta Pharmaceuticals, resulting in the issuance of 4,979,101 shares of common stock, with contingent consideration based on performance milestones[188][189]. - The fair value of contingent consideration recognized at acquisition was adjusted, resulting in a change in fair value of $2,016,111 for the nine months ended September 30, 2025[190]. - The acquired in-process research and development asset of $7,357,294 was written off as research and development expense immediately following the acquisition[191]. - The company has not recorded a liability for contingent consideration as the achievement of performance milestones is not currently deemed probable[182][190]. Clinical Trial Costs - The total remaining contract costs for a clinical trial supply agreement as of September 30, 2025, were approximately $6.3 million, with an estimated performance period through 2029[180]. - Research and development expenses are recorded as incurred, with significant costs associated with external service providers and clinical studies[184][185].
Inhibikase Therapeutics(IKT) - 2025 Q3 - Quarterly Results
2025-11-14 21:25
Financial Performance - The net loss for the quarter ended September 30, 2025, was $11.9 million, or $0.13 per share, compared to a net loss of $5.8 million, or $0.65 per share for the same quarter in 2024, indicating an increase in net loss of 105.2%[5] - The total net loss for the nine months ended September 30, 2025, was $35.5 million, or $0.40 per share, compared to a net loss of $15.4 million, or $2.03 per share for the same period in 2024, representing an increase of 130.5%[5] Cash and Securities - As of September 30, 2025, the company's cash, cash equivalents, and marketable securities totaled $77.3 million, down from $97.5 million as of December 31, 2024, representing a decrease of approximately 20.5%[4] Expenses - Research and development expenses for the quarter ended September 30, 2025, were $7.6 million, up from $4.2 million in the same quarter of 2024, reflecting an increase of 80.9%[6] - Selling, general and administrative expenses for the quarter ended September 30, 2025, were $5.6 million, compared to $1.6 million for the same quarter in 2024, marking an increase of 250%[8] - The company incurred a non-cash write-off of in-process research and development of $7.4 million for the nine months ended September 30, 2025, related to the acquisition of CorHepta[6] Clinical Development - The company plans to initiate its Phase 2b clinical study of IKT-001 in Pulmonary Arterial Hypertension (PAH) during the fourth quarter of 2025, with approximately 150 participants expected[3] Strategic Initiatives - The company appointed Timothy Pigot as Chief Commercial and Strategy Officer to enhance its strategic direction[7] - The company expects to present at the Jefferies Global Healthcare Conference in London on November 17, 2025, to discuss its developments and strategies[7] Liabilities - The total liabilities as of September 30, 2025, were $6.7 million, compared to $3.7 million as of December 31, 2024, indicating an increase of 79.5%[14]
Inhibikase Therapeutics Announces Third Quarter 2025 Financial Results and Highlights Recent Activity
Globenewswire· 2025-11-14 21:01
Core Viewpoint - Inhibikase Therapeutics, Inc. is advancing its lead product candidate IKT-001 towards a late-stage clinical trial for Pulmonary Arterial Hypertension (PAH) and reported financial results for Q3 2025, highlighting a significant increase in net loss and changes in cash position [1][4][3]. Financial Results - As of September 30, 2025, the company's cash, cash equivalents, and marketable securities totaled $77.3 million, down from $97.5 million as of December 31, 2024 [3]. - The net loss for Q3 2025 was $11.9 million, or $0.13 per share, compared to a net loss of $5.8 million, or $0.65 per share in Q3 2024. For the nine months ended September 30, 2025, the net loss was $35.5 million, or $0.40 per share, compared to a net loss of $15.4 million, or $2.03 per share for the same period in 2024 [4][14]. - Research and development expenses for Q3 2025 were $7.6 million, up from $4.2 million in Q3 2024. For the nine months ended September 30, 2025, R&D expenses totaled $23.4 million, which included a non-cash write-off of in-process R&D of $7.4 million [5]. - Selling, general and administrative expenses for Q3 2025 were $5.6 million, compared to $1.6 million in Q3 2024. For the nine months ended September 30, 2025, these expenses were $16.8 million, which included $1.0 million in severance expenses [6]. Recent Developments - The company plans to initiate a Phase 2b clinical study of IKT-001 in PAH during Q4 2025, with the trial expected to involve approximately 150 participants [2][8]. - The proposed IMPROVE-PAH trial will be a multi-center, randomized, double-blind, placebo-controlled study, with a primary efficacy endpoint of change in pulmonary vascular resistance at Week 26 [8]. - Timothy Pigot has been appointed as the Chief Commercial and Strategy Officer [8]. - The company is scheduled to present at the Jefferies Global Healthcare Conference in London on November 17, 2025 [8].