This is a two-part study. Part A consists of two different IkT-148009-201 solid dosage formulations that are being evaluated to determine their steady-state pharmacokinetic profile.
Part B is a drug-drug interaction (DDI) study focused on evaluating the impact of a strong CYP3A inhibitor on the preferred dosage determined in part A.

Start Date21 Jun 2023

Sponsor / Collaborator

Inhibikase Therapeutics, Inc.

NCT05424276 / Active, not recruitingPhase 2

A Phase 2 Study of IkT-148009 in Untreated Parkinson's Disease

This study investigates the safety and tolerability of drug IkT-148009 in untreated Parkinson's disease volunteers (30 to 80 years old). It also looks at the pharmacokinetics of IkT-148009 in the body and evaluates the effect of IkT-148009 on motor and non-motor features of the disease. This 12 week study is designed to be 3:1 randomized across 3 doses of IkT-148009 or placebo. Each participant will self-administer one of 3 doses or placebo of IkT-148009 once daily (QD) with food for 12 weeks. For more information, visit our website: www.the201trial.com

Start Date15 May 2023

Sponsor / Collaborator

Inhibikase Therapeutics, Inc.

NCT06641557 / CompletedPhase 1

A Phase I, 7-Day Dosing Study of 200 Mg IkT-148009 to Determine the Safety, Tolerability and Pharmacokinetics (PK) of IkT-148009 in Older Adult and Elderly Healthy Volunteers

This is a Phase 1 study in older adult or elderly healthy volunteer subjects to measure the safety, tolerability and pharmacokinetic (PK) profile of IkT-148009 capsules given as multiple capsules.

Start Date21 Feb 2023

Sponsor / Collaborator

Inhibikase Therapeutics, Inc.

100 Clinical Results associated with Risvodetinib

100 Translational Medicine associated with Risvodetinib

100 Patents (Medical) associated with Risvodetinib

Literatures (Medical) associated with Risvodetinib

05 Mar 2024·Journal of Parkinson's disease

A Phase I, Randomized, SAD, MAD, and PK Study of Risvodetinib in Older Adults and Parkinson’s Disease

Article

Author: Ellenbogen, Aaron ; Pellecchia, Jacqueline ; Kruger, Sydney ; Olanow, C. Warren ; Rodriguez, Carlos ; Blob, Lawrence ; Walaker, Shannon ; Safirstein, Beth ; Samara, Emil ; Hassman, Howard ; Werner, Milton H. ; Ereshefsky, Larry ; Meyer, Christopher ; McGarry, Andrew ; Klint, Carl

Background: Pre-clinical studies suggest that c-Abl activation may play an important role in the etiology of Parkinson’s disease, making c-Abl an important target to evaluate for potential disease-modification. Objective: To assess safety, tolerability, and pharmacokinetics of the c-Abl inhibitor risvodetinib (IkT-148009) in healthy subjects and participants with Parkinson’s disease. Methods: Part 1 (single ascending dose (SAD)) and Part 2 (7-day multiple ascending dose (MAD)) studies were in healthy volunteers. Participants were randomized 3 : 1 across 9 SAD doses and 3 MAD doses of risvodetinib (IkT-148009) or placebo. Part 3 was a MAD study conducted at two doses in 14 participants with mild-to-moderate PD (MAD-PD). Primary outcome measures were safety, tolerability and pharmacokinetics. Exploratory outcomes in PD participants included clinical measures of PD state, GI function, and cerebrospinal fluid (CSF) concentration. Results: 108 patients were treated with no dropouts. The SAD tested doses ranging from 12.5 to 325 mg, while the MAD tested 25 to 200 mg and MAD-PD tested 50 to 100 mg in Parkinson’s participants. All active doses had a favorable safety profile with no clinically meaningful adverse events. Single dose pharmacokinetics were approximately linear between 12.5 mg and 200 mg for both Cmax and AUC0 - inf without distinction between healthy volunteers and participants with PD. Exposures at each dose were high relative to other drugs in the same kinase inhibitor class. Conclusions: Risvodetinib (IkT-148009) was well tolerated, had a favorable safety and pharmacology profile over 7-day dosing, did not induce serious adverse events and did not appear to induce deleterious side-effects in participants administered anti-PD medications.

18 Jan 2023·Science translational medicineQ1 · MEDICINE

The c-Abl inhibitor IkT-148009 suppresses neurodegeneration in mouse models of heritable and sporadic Parkinson’s disease

Q1 · MEDICINE

Article

Author: Rush, Roger ; Marino Lee, Shirley ; Dawson, Valina L. ; Kim, Erica ; Nguyen, Richard ; Dang, Brianna ; Werner, Milton H. ; Wang, Hu ; Sloan, Nicholas ; Kelly, Terence ; Dawson, Ted M. ; Brahmachari, Saurav ; Bisen, Shivani ; Lee, Hyeun Woo ; Karuppagounder, Senthilkumar S. ; Yamashita, Yoko ; Sigmon, Alexander ; Watkins, Leslie ; Kumar, Manoj

Parkinson’s disease (PD) is the second most prevalent neurodegenerative disease of the central nervous system, with an estimated 5,000,000 cases worldwide. PD pathology is characterized by the accumulation of misfolded α-synuclein, which is thought to play a critical role in the pathogenesis of the disease. Animal models of PD suggest that activation of Abelson tyrosine kinase (c-Abl) plays an essential role in the initiation and progression of α-synuclein pathology and initiates processes leading to degeneration of dopaminergic and nondopaminergic neurons. Given the potential role of c-Abl in PD, a c-Abl inhibitor library was developed to identify orally bioavailable c-Abl inhibitors capable of crossing the blood-brain barrier based on predefined characteristics, leading to the discovery of IkT-148009. IkT-148009, a brain-penetrant c-Abl inhibitor with a favorable toxicology profile, was analyzed for therapeutic potential in animal models of slowly progressive, α-synuclein–dependent PD. In mouse models of both inherited and sporadic PD, IkT-148009 suppressed c-Abl activation to baseline and substantially protected dopaminergic neurons from degeneration when administered therapeutically by once daily oral gavage beginning 4 weeks after disease initiation. Recovery of motor function in PD mice occurred within 8 weeks of initiating treatment concomitantly with a reduction in α-synuclein pathology in the mouse brain. These findings suggest that IkT-148009 may have potential as a disease-modifying therapy in PD.

News (Medical) associated with Risvodetinib

14 Nov 2024

·www.globenewswire.com

Inhibikase Therapeutics Reports Third Quarter Financial Results and Highlights Recent Activity

-- Transformative Financing worth up to $275 million from Top-Tier Institutional Healthcare Investors -- -- Advancement of IkT-001Pro into a Late-Stage Clinical Trial Program in Pulmonary Arterial Hypertension -- --201 Trial Results to be reported in 4Q2024 -- BOSTON and ATLANTA, Nov. 14, 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 Cardiopulmonary and Neurodegenerative disease through Abelson Tyrosine Kinase inhibition, today reported financial results for the third quarter ended September 30, 2024 and highlighted recent developments. “The financing we concluded in October was a transformational moment for Inhibikase, and positioned us to advance IkT-001Pro into a late-stage clinical trial in Pulmonary Arterial Hypertension (PAH),” said Dr. Milton Werner, President and Chief Executive of Inhibikase. “This investment, with top tier dedicated healthcare investment funds, recognized the potential of IkT-001Pro to improve the lives of patients afflicted with PAH. We believe IkT-001Pro, a prodrug of imatinib, has the potential to ameliorate the safety and tolerability profile that precluded approval of imatinib for the treatment of PAH more than 10 years ago. This investment further validates the Company’s innovative approach to the development of kinase inhibitor therapeutics in the non-oncology setting.” Recent Developments and Upcoming Milestones: Closed up to $275 million financing in October 2024 in support of advancing IkT-001Pro into a late-stage clinical trial in PAH Private placement of approximately $110 million from the issuance and sale of shares of the Company’s common stock and accompanying warrants with potential aggregate financing of up to approximately $275 million upon the full cash exercise of the warrants issued in the private placement, before deducting placement fees and offering expenses. The financing will fund execution of the Phase 2b ‘702’ trial in Pulmonary Arterial Hypertension (PAH) and general corporate purposes. Added three highly accomplished leaders in biopharmaceutical development and a Partner of Soleus Capital to the Board of Directors coincident with the financing: Roberto Bellini, Managing Partner of BSQUARED Capital and former Chief Executive Officer of BELLUS Health Inc.Amit Munshi, Chief Executive Officer of Orna Therapeutics and former CEO of Arena Pharmaceuticals,Arvind Kush, Chief Financial Officer and Chief Business Officer of Candid Therapeutics and former CFO of RayzeBioDavid Canner, Partner at Soleus CapitalIn addition to joining the Board of Directors, Messers. Bellini, Munshi and Kush each participated in the financing; Mr. Bellini has been appointed Independent Chairperson of the Inhibikase Board. Advancement of IkT-001Pro as a therapy in Pulmonary Arterial Hypertension: The Company received its Study May Proceed letter on September 9, 2024.The active ingredient in IkT-001Pro, imatinib, has previously been shown to be disease-modifying for PAH. The Company believes that IkT-001Pro could have a more favorable safety and tolerability profile compared to imatinib for this indication.Following the Company’s pre-NDA meeting with the FDA in January 2024, Inhibikase enhanced its manufacturing process development efforts for IkT-001Pro to support late-stage clinical development. Ongoing activities include development of new dosage forms, a more efficient production process and a high throughput tableting process that will lead to dosage forms for 001Pro tablets that are differentiated from generic imatinib mesylate in alignment with FDA feedback. The last patient and last visit in the Phase 2 201 Trial evaluating risvodetinib (also known as IkT-148009) in untreated Parkinson’s disease occurred in October, 2024; topline data is expected in the fourth quarter of 2024. The trial randomized 126 patients total, 120 of which completed the 12 week double blind dosing period. Third Quarter Financial Results Net Loss: Net loss for the quarter ended September 30, 2024, was $5.8 million, or $0.65 per share, compared to a net loss of $4.6 million, or $0.75 per share in the quarter ended September 30, 2023. The net loss per share does not give effect to the shares issued in the October 2024 financing. R&D Expenses: Research and development expenses were $4.2 million for the quarter ended September 30, 2024 compared to $3.23 million in the quarter ended September 30, 2023. SG&A Expenses: Selling, general and administrative expenses for the quarter ended September 30, 2024 were $1.6 million compared to $1.62 million for the quarter ended September 30, 2023. Cash Position: Cash, cash equivalents and marketable securities were $3.2 million as of September 30, 2024, which does not include the gross proceeds of approximately $110 million from the October 2024 Offering. About Inhibikase (www.inhibikase.com) Inhibikase Therapeutics, Inc. (Nasdaq: IKT) is a clinical-stage pharmaceutical company developing Abelson Tyrosine Kinase inhibitor therapeutics for Cardiopulmonary and Neurodegenerative disease. Inhibikase’s cardiopulmonary disease portfolio is led by IkT-001Pro, a prodrug of imatinib mesylate, for Pulmonary Arterial Hypertension that will deliver imatinib in a form that the Company believes will provide a better patient experience with fewer on-dosing side-effects. Inhibikase's neurodegenerative disease portfolio is led by risvodetinib, a selective c-Abl inhibitor to treat Parkinson’s and Parkinson’s-related disease. Inhibikase is headquartered in Atlanta, Georgia with offices in Lexington, Massachusetts. Social Media Disclaimer Investors and others should note that the Company announces material financial information to investors using its investor relations website, press releases, SEC filings and public conference calls and webcasts. The Company intends to also use X, Facebook, LinkedIn and YouTube as a means of disclosing information about the Company, its services and other matters and for complying with its disclosure obligations under Regulation FD. Forward-Looking Statements This press release contains "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking terminology such as "believes," "expects," "may," "will," "should," "anticipates," "plans," or similar expressions or the negative of these terms and similar expressions are intended to identify forward-looking statements. These forward-looking statements are based on Inhibikase's current expectations and assumptions. Such statements are subject to certain risks and uncertainties, which could cause Inhibikase's actual results to differ materially from those anticipated by the forward-looking statements. Important factors that could cause actual results to differ materially from those in the forward-looking statements include our ability to commence and execute a Phase 2b ‘702’ trial to evaluate IkT-001Pro as a treatment for Pulmonary Arterial Hypertension (PAH), whether our top line data from our Phase 2 201 Trial evaluating risvodetinib in untreated Parkinson’s disease will show a statistically significant clinical benefit to trial participants, as well as such other factors that are included in our periodic reports on Form 10-K and Form 10-Q that we file with the U.S. Securities and Exchange Commission. Any forward-looking statement in this release speaks only as of the date of this release. Inhibikase undertakes no obligation to publicly update or revise any forward-looking statement, whether as a result of new information, future developments or otherwise, except as may be required by any applicable securities laws. Contacts: Company Contact:Milton H. Werner, PhDPresident & CEO678-392-3419info@inhibikase.com Investor Relations:Michael MoyerLifeSci Advisorsmmoyer@lifesciadvisors.com Inhibikase Therapeutics, Inc.Condensed Consolidated Balance Sheets(Unaudited) September 30,2024 December 31,2023 (unaudited) (Note 2)Assets Current assets: Cash and cash equivalents $913,420 $9,165,179 Marketable securities 2,330,226 4,086,873 Prepaid research and development 112,225 219,817 Deferred offering costs 553,318 — Prepaid expenses and other current assets 280,914 739,179 Total current assets 4,190,103 14,211,048 Equipment and improvements, net 53,667 73,372 Right-of-use asset 133,105 222,227 Total assets $4,376,875 $14,506,647 Liabilities and stockholders’ equity Current liabilities: Accounts payable $2,529,220 $646,767 Lease obligation, current 145,210 150,095 Accrued expenses and other current liabilities 2,161,374 2,259,955 Insurance premium financing payable 71,662 381,784 Total current liabilities 4,907,466 3,438,601 Lease obligation, net of current portion — 90,124 Total liabilities 4,907,466 3,528,725 Commitments and contingencies (see Note 13) Stockholders’ equity: Preferred stock, $0.001 par value; 10,000,000 shares authorized; 0 shares issued and outstanding at September 30, 2024 and December 31, 2023 — — Common stock, $0.001 par value; 100,000,000 shares authorized; 7,464,070 and 6,186,280 shares issued and outstanding at September 30, 2024 and December 31, 2023 7,464 6,186 Additional paid-in capital 81,748,225 77,871,584 Accumulated other comprehensive (loss) income 1,754 877 Accumulated deficit (82,288,034) (66,900,725)Total stockholders' equity (530,591) 10,977,922 Total liabilities and stockholders’ (deficit) equity $4,376,875 $14,506,647 Inhibikase Therapeutics, Inc.Condensed Consolidated Statements of Operations and Comprehensive Loss(Unaudited) Three Months Ended September 30, Nine Months Ended September 30, 2024 2023 2024 2023 Revenue: Grant revenue$— $79,569 $— $260,500 Total revenue — 79,569 — 260,500 Costs and expenses: Research and development 4,189,873 3,225,551 10,016,982 10,615,368 Selling, general and administrative 1,637,603 1,622,894 5,643,386 5,331,358 Total costs and expenses 5,827,476 4,848,445 15,660,368 15,946,726 Loss from operations (5,827,476) (4,768,876) (15,660,368) (15,686,226)Interest income (expense) 49,410 173,677 273,059 835,283 Net loss (5,778,066) (4,595,199) (15,387,309) (14,850,943)Other comprehensive loss, net of tax Unrealized gains (loss) on marketable securities 2,778 1,571 877 (104,861)Comprehensive Loss$(5,775,288) $(4,593,628) $(15,386,432) $(14,955,804)Net loss per share – basic and diluted$(0.65) $(0.75) $(2.03) $(2.48)Weighted-average number of common shares – basic and diluted 8,882,570 6,162,671 7,592,103 5,977,841

Phase 2Financial StatementExecutive ChangeNDAPhase 1

25 Oct 2024

·www.globenewswire.com

Inhibikase Therapeutics Announces Closing of up to $275 Million Financing and Advancement of IkT-001Pro into a Late Stage Clinical Trial in Pulmonary Arterial Hypertension

-- IkT-001Pro to be developed as a New Molecular Entity as the first oral, potentially disease-modifying treatment for a rapidly fatal disease primarily afflicting women between the ages of 30 and 60 -- Oct. 21, 2024 -- Inhibikase Therapeutics, Inc. (Nasdaq: IKT) (“Inhibikase” or “Company”), a clinical-stage pharmaceutical company developing protein kinase inhibitor therapeutics to modify the course of Cardiopulmonary and Neurodegenerative disease through Abelson Tyrosine Kinase inhibition, today announced the closing of a private placement of approximately $110 Million from the issuance and sale of shares of the Company’s common stock and accompanying warrants with potential aggregate financing of up to approximately $275 Million upon the full cash exercise of the warrants issued in the private placement, before deducting placement agent fees and offering expenses. The financing will fund execution of the Phase 2b ‘702’ trial in Pulmonary Arterial Hypertension (PAH) and for general corporate purposes. “This transformational financing for Inhibikase is a testament to the Company’s persistent scientific and medical focus to develop disease-modifying therapeutics that could improve the lives of millions of patients afflicted with cardiopulmonary and neurodegenerative diseases,” noted Dr. Milton Werner, President and Chief Executive of Inhibikase. “Imatinib, the active ingredient in IkT-001Pro, had previously been shown to provide significant clinical benefit and improve heart health as an oral, once a day therapy, albeit with an unacceptable safety and tolerability profile. We believe imatinib delivered as IkT-001Pro has the potential to ameliorate the safety and tolerability profile that precluded approval of imatinib more than 10 years ago. With this investment, top tier dedicated healthcare investment funds recognized the potential of IkT-001Pro to improve the lives of patients afflicted with PAH. As with risvodetinib in Parkinson’s-related diseases, IkT-001Pro is a product of the Company’s innovative medicinal chemistry program that designs and develops novel kinase inhibitor therapeutics.” Concurrent with the closing of this financing, three highly accomplished leaders in biopharmaceutical development and a Partner of Soleus Capital with deep experience in financing cardiopulmonary therapeutics development will join the Board of Directors at the closing of this transaction. Roberto Bellini (former Chief Executive of BELLUS Health Inc. and current Managing Partner of BSQUARED Capital), Amit Munshi (current Chief Executive of Orna Therapeutics and former CEO of Arena Pharmaceuticals), Arvind Kush (current CFO of Candid Therapeutics and former CFO of RayzeBio) and David Canner (Partner at Soleus Capital) have been appointed to the Inhibikase Board of Directors. In addition to joining the Board of Directors, Messers. Bellini, Munshi and Kush will each participate in the transaction. Mr. Bellini has been appointed Independent Chairperson of the Inhibikase Board coincident with the closing. In addition to these new Board members, Ms. Gisele Dion, Chair of the Audit Committee and Dr. Paul Grint, Chair of the Compensation Committee, have resigned from their service on the Board. The Company is grateful for their dedicated service, their thoughtful guidance and efforts that were an integral part of the program advancements leading to this investment. “I am excited about IkT-001Pro as a potential treatment for PAH patients,” noted Mr. Bellini. “I look forward to leveraging my recent experience at BELLUS Health to support the company’s strategic growth.” “I want to express my excitement to join the Inhibikase Board at this transformative moment for the company,” said Mr. Munshi. “Inhibikase, under Dr. Werner’s leadership, is poised to create a fundamental shift in the lives of patients suffering from these debilitating and fatal diseases,” said Mr. Munshi. “This financing is an important milestone for Inhibikase, and I’m thrilled to be joining the Board,” added Mr. Kush. “The capital from top tier investors is transformative and will enable the rapid development of IkT-001Pro for PAH.” Roberto Bellini is currently a Managing Partner at BSQUARED Capital, a family office biotech fund. He previously served as President and CEO of BELLUS Health between January 2010 and July 2023. Under his leadership BELLUS Health developed camlipixant, a P2X3 antagonist for chronic cough from preclinical to Phase 3. BELLUS Health was subsequently acquired by GSK plc in 2023. Mr. Bellini holds a Bachelor of Science in Biochemistry from McGill University. Amit Munshi is a 30-year industry veteran who is currently Chief Executive Officer of Orna Therapeutics and former President, Chief Executive Officer and board member of ReNAgade Therapeutics. Previously Mr. Munshi served as President and CEO of Arena Pharmaceuticals Inc., which was subsequently sold to Pfizer, Inc. Arvind Kush, the Chief Financial and Chief Business Officer of Candid Therapeutics, has over 15 years of finance and investment banking experience. Prior to Candid, Arvind was Chief Financial Officer at RayzeBio, where he helped the company raise over $160 million in a private financing in 2022, complete its $350+ million IPO in 2023 and close its $4.1B acquisition Bristol Meyers Squibb in February 2024. Arvind holds a Bachelor in Engineering in Computer Science from Visvesvaraya Technological University and an MBA from Goizueta Business School, Emory University. David Canner is a Partner at Soleus Capital. David has served on the board for a number of companies. Prior to joining Soleus in 2018, David completed his PhD at MIT in Biology after finishing his undergraduate studies at Princeton University where he received a BA in Chemistry. IkT-001Pro is a prodrug formulation of imatinib mesylate and has been developed to improve the safety of the first FDA-approved Abelson (Abl) kinase inhibitor, imatinib (originally marketed as Gleevec®). Imatinib is commonly taken for hematological and gastrointestinal cancers that arise from Abl kinase mutations found in the bone marrow or for gastrointestinal cancers that arise from c-Kit and/or PDGFRa/b mutations in the stomach; c-Kit, PDGFRa/b and Abl are all members of the Abelson Tyrosine Kinase protein family. In a previously published Phase 3 trial (the IMPRES trial, published in 2013 in the journal Circulation, volume 127, pages 1128-1138), imatinib was shown to induce a clinically meaningful improvement in 6 minute walking distance (6MWD) of approximately 40 meters and reduce pulmonary vascular resistance by more than 300 dyne-sec/cm, improve other measures of heart health and approximately 30% of participants actually got better with imatinib added to their standard-of-care at a dose of 400 mg once daily. IkT-001Pro has the potential to be a safer, better tolerated alternative for imatinib therapy in patients with PAH. In preclinical studies, IkT-001Pro was shown to be as much as 3.4 times safer and/or better tolerated than imatinib in non-human primates, reducing burdensome gastrointestinal and other on-dosing side effects that occur following oral administration. The 702 trial evaluating IkT-001Pro in PAH was IND-cleared for clinical entry at Phase 2b by the FDA on September 9, 2024. Imatinib delivered as IkT-001Pro was granted Orphan Drug Designation for Stable-Phase CML in 2018, and Orphan Drug Designation is presently under review for PAH. The securities (including the shares of common stock underlying the pre-funded warrants and warrants) were offered in a private placement under Section 4(a)(2) of the Securities Act of 1933, as amended (the “Securities Act”) and have not been registered under the Securities Act, or any state or other applicable jurisdictions’ securities laws, and may not be offered or sold in the United States absent registration or an applicable exemption from the registration requirements of the Securities Act and applicable state or other jurisdictions’ securities laws. This press release shall not constitute an offer to sell or a solicitation of an offer to buy these securities, nor shall there be any sale of these securities in any state or other jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such state or other jurisdiction. Any offering of the securities under the resale registration statement will only be made by means of a prospectus. Inhibikase Therapeutics, Inc. (Nasdaq: IKT) is a clinical-stage pharmaceutical company developing Abelson Tyrosine Kinase inhibitor therapeutics for Cardiopulmonary and Neurodegenerative disease. Inhibikase's multi-therapeutic pipeline includes its neurodegenerative disease portfolio led by risvodetinib in Parkinson’s disease, Multiple System Atrophy and other diseases that may arise from alpha-synuclein aggregate formation. Inhibikase’s cardiopulmonary disease portfolio is led by IkT-001Pro, a prodrug of imatinib mesylate, for Pulmonary Arterial Hypertension that will deliver imatinib in a form that the Company believes will provide a better patient experience with fewer on-dosing side-effects. The Company's RAMP™ medicinal chemistry program has identified several follow-on compounds to risvodetinib that could potentially be applied to other cognitive and motor function diseases of the brain. Inhibikase is headquartered in Atlanta, Georgia with offices in Lexington, Massachusetts. The content above comes from the network. if any infringement, please contact us to modify.

Executive ChangeOrphan DrugClinical Result

09 Oct 2024

·www.globenewswire.com

Inhibikase Therapeutics Announces Pricing of $110 Million Private Placement to Advance IkT-001Pro, an Optimized Prodrug of Imatinib, into a Late-Stage Trial in Pulmonary Arterial Hypertension

-- Aggregate investment of up to approximately $275 Million by healthcare-focused investment funds, led by Soleus Capital -- BOSTON and ATLANTA, Oct. 09, 2024 (GLOBE NEWSWIRE) -- Inhibikase Therapeutics, Inc. (Nasdaq: IKT) (“Inhibikase” or the “Company”), a clinical-stage pharmaceutical company developing protein kinase inhibitor therapeutics to modify the course of cardiopulmonary and neurodegenerative disease through Abelson Tyrosine Kinase inhibition, today announced the pricing of an approximately $110 million private placement financing, before deducting placement agent fees and other offering expenses. The Company intends to use the net proceeds from the private placement to finance the initiation of a Phase 2b trial in pulmonary arterial hypertension (“PAH”) and for general corporate purposes. The private placement was led by new investor Soleus Capital, with participation from new investors including Sands Capital, Fairmount, Blackstone Multi-Asset Investing, Commodore Capital, Perceptive Advisors, ADAR1 Capital Management, BSQUARED Capital, Nantahala Capital, Stonepine Capital Management and Spruce Street Capital. In connection with and to be effective immediately prior to the closing of this financing, two current members of the Board of Directors, Ms. Gisele Dion and Dr. Paul Grint, will resign and four new directors will join the Company’s board: Roberto Bellini (former Chief Executive of BELLUS Health Inc. and current Managing Partner of BSQUARED Capital), Amit Munshi (current Chief Executive of Orna Therapeutics and former CEO of Arena Pharmaceuticals), Arvind Kush (current CFO of Candid Therapeutics and former CFO of RayzeBio) and David Canner (Partner at Soleus Capital). In addition, Mr. Bellini will serve as Independent Chairperson of the Board of Directors. The Company is selling an aggregate of 58,310,000 shares of its common stock and, in lieu of common stock to certain investors, pre-funded warrants to purchase up to an aggregate of 21,985,000 shares of common stock, along with accompanying Series A-1 warrants to purchase an aggregate of 40,139,474 shares of common stock (or, in lieu thereof, additional pre-funded warrants) (the “Series A-1 Warrants”) and accompanying Series B-1 warrants to purchase an aggregate of 73,813,529 shares of common stock (or, in lieu thereof, additional pre-funded warrants) (the “Series B-1 Warrants”). The purchase price for each share of common stock and accompanying warrants is $1.37 (provided, the purchase price for each pre-funded warrant and accompanying warrants is $1.369). The pre-funded warrants have an exercise price of $0.001 per share and are exercisable at any time after their original issuance and will not expire. The accompanying Series A-1 and Series B-1 Warrants will become exercisable at the earlier of (a) the 75th calendar day following the initial filing of the resale registration statement covering the resale of the shares of common stock issuable upon the exercise of the warrants, if the United States Securities and Exchange Commission (the “SEC”) notifies the Company that it will review the resale registration statement and (b) the 5th business day after the date the Company is notified by the SEC that the resale registration statement will not be subject to further review. Each Series A-1 Warrant will be exercisable for approximately 0.5 shares of common stock and will expire 30 days following the later of (a) the date of the Company’s public announcement of the safety and tolerability of IkT-001Pro for PAH and (b) the Company both obtaining stockholder approval to and filing an amendment to its charter to increase the number of authorized shares of common stock to a number of shares of common stock sufficient to allow for the full exercise of the warrants (the ‘Charter Amendment”). Each Series B-1 Warrant will be exercisable for approximately 0.92 shares of common stock, will become exercisable by an investor once all of such investor’s A-1 Warrants have been exercised and will expire 30 days following the later of (a) the Company’s public announcement of its Phase 2b efficacy readout for IkT-001Pro with respect to PAH and (b) the Charter Amendment. The Series A-1 Warrants have an exercise price of $1.37 per share and the Series B-1 Warrants have an exercise price of $1.49 per share. The PIPE is expected to close on October 21, 2024, subject to customary closing conditions. Jefferies is acting as the lead placement agent for the private placement. Maxim Group LLC is acting as a co-placement agent. The securities to be issued (including the shares of common stock underlying the pre-funded warrants and warrants) were offered in a private placement under Section 4(a)(2) of the Securities Act of 1933, as amended (the “Securities Act”)and have not been registered under the Securities Act, or any state or other applicable jurisdictions’ securities laws, and may not be offered or sold in the United States absent registration or an applicable exemption from the registration requirements of the Securities Act and applicable state or other jurisdictions’ securities laws. As part of the private placement, Inhibikase Therapeutics has agreed to file a registration statement with the SEC registering the resale of the shares of common stock issued in the private placement and the shares of common stock issuable upon the exercise of the pre-funded warrants and accompanying warrants issued in the private placement, no later than 30 days after the closing of the private placement. This press release shall not constitute an offer to sell or a solicitation of an offer to buy these securities, nor shall there be any sale of these securities in any state or other jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such state or other jurisdiction. Any offering of the securities under the resale registration statement will only be made by means of a prospectus. About Inhibikase Inhibikase Therapeutics, Inc. (Nasdaq: IKT) is a clinical-stage pharmaceutical company developing Abelson Tyrosine Kinase inhibitor therapeutics for Cardiopulmonary and Neurodegenerative disease. Inhibikase's multi-therapeutic pipeline includes its neurodegenerative disease portfolio led by risvodetinib in Parkinson’s disease, Multiple System Atrophy and other diseases that may arise from alpha-synuclein aggregate formation. Inhibikase’s cardiopulmonary disease portfolio is led by IkT-001Pro, a prodrug of imatinib mesylate, for Pulmonary Arterial Hypertension that will deliver imatinib in a form that the Company believes will provide a better patient experience with fewer on-dosing side-effects. The Company's RAMP™ medicinal chemistry program has identified several follow-on compounds to risvodetinib that could potentially be applied to other cognitive and motor function diseases of the brain. Inhibikase is headquartered in Atlanta, Georgia with offices in Lexington, Massachusetts. Forward-Looking Statements This press release contains "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking terminology such as "believes," "expects," "may," "will," "should," "anticipates," "plans," or similar expressions or the negative of these terms and similar expressions are intended to identify forward-looking statements. These forward-looking statements are based on Inhibikase's current expectations and assumptions. Such statements are subject to certain risks and uncertainties, which could cause Inhibikase's actual results to differ materially from those anticipated by the forward-looking statements. Important factors that could cause actual results to differ materially from those in the forward-looking statements include our ability to enroll and complete clinical trials with risvodetinib or IkT-001Pro that demonstrate a statistically significant clinical benefit to the trial participants and whether results from our animal studies may be replicated in humans, our ability to satisfy customary closing conditions for the offering, and our ability to obtain stockholder approval to increase the number of authorized shares of common stock underlying the Series A-1 Warrants and Series B-1 Warrants, as well as such other factors that are included in our periodic reports on Form 10-K and Form 10-Q that we file with the U.S. Securities and Exchange Commission. Any forward-looking statement in this release speaks only as of the date of this release. Inhibikase undertakes no obligation to publicly update or revise any forward-looking statement, whether as a result of new information, future developments or otherwise, except as may be required by any applicable securities laws. Contacts: Company Contact:Milton H. Werner, PhDPresident & CEO678-392-3419info@inhibikase.com Investor Relations:Michael Moyer617-308-4306Life Science Advisorsmmoyer@lifesciadvisors.com

Phase 2Executive Change

100 Deals associated with Risvodetinib

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Indication	Highest Phase	Country/Location	Organization	Date
Constipation	Phase 2	-	Inhibikase Therapeutics, Inc.	23 May 2022
Deglutition Disorders	Phase 2	-	Inhibikase Therapeutics, Inc.	23 May 2022
Parkinson Disease	Phase 2	US	Inhibikase Therapeutics, Inc.	23 May 2022
Multiple System Atrophy	Phase 1	US	Inhibikase Therapeutics, Inc.	-

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT04350177 (Pubmed) Manual	Phase 1	Parkinson Disease	108	Risvodetinib	npzzdxtrvb(judobdlikk) = All active doses had a favorable safety profile with no clinically meaningful adverse events. fqniarrmje (gpryhqdydq ) View more	Positive	13 Jan 2024
MDS2023	Not Applicable	Parkinson Disease	-	IkT-148009	xafsyvbkxx(caqjbpczki) = iwyqeglzlh kbhwealdhp (vxktlijwfx ) View more	-	27 Aug 2023
NCT04350177 (MDS2022) Manual	Phase 1	Parkinson Disease	88	IkT-148009	nvddyqsxwv(twcelhreec) = The safety and tolerability profile of IkT-148009 in healthy subjects was consistent with chronic toxicology studies in rat and monkey. PD patiewts with mild to moderate disease (Hoehn & Yahr < 3.0) displayed a similar profile of safety and tolerability. cpdjzhzdpe (mpbtbuooej )	Positive	18 Sep 2022

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