1. BOSTON and ATLANTA, Jan. 5, 2022 /PRNewswire/ -- Inhibikase Therapeutics, Inc. (NASDAQ:IKT) (Inhibikase), a clinical-stage pharmaceutical company developing therapeutics to modify the course of Parkinson's disease and related disorders, today highlighted recent developments and anticipated milestones for 2022.

    Key Business and Clinical milestones expected in 2022:

    • Continue Phase 1 dose escalation of IkT-148009 in older and elderly healthy volunteers: IkT-148009 continues to be evaluated at higher single doses in older and elderly healthy volunteers as part of the Phase 1 study, which was initiated in February 2021. To date, no clinically significant adverse events have been observed at doses up to 175 mg. Although total drug exposures measured in blood are very high compared to other drugs approved in the c-Abl inhibitor class, few laboratory abnormalities have been observed. The large systemic exposure and the absence of significant adverse events provides the opportunity to evaluate a wide dosing range in future Phase 2 and Phase 3 studies. Inhibikase expects to continue dosing patients up to a single dose of 250 mg to identify a Maximum Tolerated Dose in the first quarter of 2022 and may increase the dose beyond 250 mg subject to safety committee review.



    • Complete first two cohorts in Phase 1b study of IkT-148009 in patients with Parkinson's Disease: The Phase 1b study is a 3:1 randomized, placebo-controlled dose escalation trial evaluating the safety, tolerability, and pharmacokinetics of seven-day dosing of IkT-148009 at three escalating dose levels. Inhibikase expects to complete enrollment and analysis of the first two cohorts of 8 patients with mild to moderate Parkinson's disease in the first quarter of 2022, with the third cohort completed in the second quarter of 2022. The study is also assessing motor and non-motor function, gut motility, and measures of alpha-synuclein aggregate clearance as exploratory endpoints.



    • Submit complete chronic toxicology data for IkT-148009 to the U.S. Food and Drug Administration (FDA) in the first quarter of 2022: In October 2021, Inhibikase reported that it had submitted interim 13-week results from its ongoing chronic toxicology studies of IkT-148009 in rats and non-human primates to the FDA. Inhibikase expects to submit the full chronic toxicology dataset, including nine-month toxicology outcomes in non-human primates, to the FDA in the first quarter of 2022. Previously submitted interim data indicated that the toxicology profile of IkT-148009 improves with extended daily oral dosing and supports evaluation in Parkinson's patients for three months or longer, subject to review by and agreement with the U.S. FDA.



    • Meet with the FDA to discuss the development program of IkT-148009 as a treatment for Parkinson's disease: The Company's Fast-Track Designation request has not been granted by the FDA but remains under further consideration. As part of the review, the FDA requested that Inhibikase meet with the Agency to review the Company's near and long-term development plans and proposed efficacy measures for IkT-148009 as a treatment for Parkinson's disease. It is expected this meeting will take place in the first quarter of 2022.



    • Initiate Phase 2a clinical study for IkT-148009 in patients with Parkinson's Disease:  Inhibikase expects to dose the first patient in a Phase 2a study of IkT-148009 in untreated Parkinson's Disease in the second quarter of 2022, subject to agreements with the FDA. The 3:1 randomized, double-blind, twelve-week trial will evaluate the safety and tolerability of three doses of IkT-148009 in up to 120 patients diagnosed with Parkinson's disease who have not yet progressed to the need for symptomatic treatment. The trial will also measure motor and non-motor function inside and outside of the brain as secondary endpoints and evaluate whether treatment with IkT-148009 leads to a reduction or clearance of pathogenic alpha-synuclein aggregates inside and outside of the central nervous system as exploratory endpoints. 



    • Complete preclinical studies evaluating IkT-148009 in animal models of Multiple System Atrophy (MSA) in preparation for Phase 2 clinical studies: Inhibikase expects to report preclinical data studying IkT-148009 in at least one of two animal models of MSA in the second quarter of 2022. The studies are evaluating whether inhibition of the Abelson Tyrosine Kinase, or c-Abl, could have a therapeutic benefit in MSA. The potential role of c-Abl in the disease process was highlighted in the Company's recent publication published in the peer reviewed journal Neurobiology of Disease1. Based on the preclinical results from these studies and subject to agreement with the FDA and equivalent regulatory bodies in the European Union, Inhibikase expects to advance IkT-148009 into a Phase 2a clinical study by the third quarter of 2022.



    • Submit Investigational New Drug application (IND) for IkT-001Pro for stable-phase Chronic Myelogenous Leukemia (CML) in the first quarter of 2022: Commercially viable large-scale manufacturing of IkT-001Pro has been under development and resulted in the production of the first clinical batch at the close of 2021. As a result, Inhibikase expects to submit the IND for IkT-001Pro in the first quarter of 2022 and commence bioequivalence studies in accordance with the 505(b)(2) regulatory pathway following receipt of a Study May Proceed letter and other agreements with the FDA.



    • Medicinal chemistry insights into the selectivity, potency and brain penetration of IkT-148009 and related inhibitors lead to a library of potential second generation molecules: New insights into the origins of IkT-148009's selectivity, safety, toxicology and potency have let to improved designs for c-Abl inhibitors. These new designs could build on the discoveries into how IkT-148009 and other molecules in Inhibikase's portfolio cross the blood-brain barrier, remain in the central nervous system for extended periods of time and reduce the likelihood of efflux transport back into the systemic circulation. These insights and discoveries could lead to long-acting product offerings with less frequent dosing and improved safety profiles.

    "2021 was a transformational year for Inhibikase, as we became a clinical stage Company, advanced multiple programs forward in the clinic, and reinforced our balance sheet to support our growth over the coming years," commented Dr. Milton H. Werner, President and Chief Executive Officer of Inhibikase. "In 2022, we will continue to work diligently to advance our programs in multiple therapeutic areas that include Parkinson's disease, MSA, and stable phase CML as we seek to treat these devastating diseases. In addition, through our research and publications, we will continue to shape the conversation around Parkinson's disease and the potential role of alpha-synuclein in disease initiation and progression, as we recently described in a peer-reviewed publication in Movement Disorders2. We expect 2022 to be another significant year for the Company and look forward achieving our outlined milestones as we seek to improve the lives of millions of patients."

    About Inhibikase (www.inhibikase.com

    Inhibikase Therapeutics, Inc. (NASDAQ:IKT) is a clinical-stage pharmaceutical company developing therapeutics for Parkinson's disease and related disorders. Inhibikase's multi-therapeutic pipeline focuses on neurodegeneration and its lead program IkT-148009, an Abelson Tyrosine Kinase (c-Abl) inhibitor, targets the treatment of Parkinson's disease inside and outside the brain. Its multi-therapeutic pipeline is pursuing Parkinson's-related disorders of the brain and GI tract, orphan indications related to Parkinson's disease such as Multiple System Atrophy, or MSA, and drug delivery technologies for kinase inhibitors such as IkT-001Pro, a prodrug of the anticancer agent Imatinib 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 a number of follow-on compounds to IkT-148009 to be applied to other cognitive and motor function diseases of the brain. Inhibikase is headquartered in Atlanta, Georgia with offices in Boston, Massachusetts.

    Social Media Disclaimer

    Investors and others should note that we announce material financial information to our investors using our investor relations website, press releases, SEC filings and public conference calls and webcasts. The company intends to also use TwitterFacebookLinkedIn 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 are set forth in Inhibikase's filings with the SEC, including its registration statement on Form S-1, as amended (File No. 333-240036), including under the caption "Risk Factors." 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.

    1 doi: 10.1016/j.nbd.2020.105184

    2 doi: 10.1002/mds.28858

     

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  2. BOSTON and ATLANTA, Nov. 29, 2021 /PRNewswire/ -- Inhibikase Therapeutics, Inc. (NASDAQ:IKT) ("Inhibikase" or "Company"), a clinical-stage pharmaceutical company developing therapeutics to modify the course of Parkinson's disease and related disorders, today announced the publication of a paper describing the biochemical rationale and potential benefit of Abelson Tyrosine Kinase (c-Abl) inhibition as a potential disease-modifying therapy for Parkinson's Disease. The article, titled "Parkinson's Disease Modification Through Abl Kinase Inhibition: An Opportunity" was published online in the journal Movement Disorders on November 24, 2021 (DOI:  10/1002/mds.28858).

    BOSTON and ATLANTA, Nov. 29, 2021 /PRNewswire/ -- Inhibikase Therapeutics, Inc. (NASDAQ:IKT) ("Inhibikase" or "Company"), a clinical-stage pharmaceutical company developing therapeutics to modify the course of Parkinson's disease and related disorders, today announced the publication of a paper describing the biochemical rationale and potential benefit of Abelson Tyrosine Kinase (c-Abl) inhibition as a potential disease-modifying therapy for Parkinson's Disease. The article, titled "Parkinson's Disease Modification Through Abl Kinase Inhibition: An Opportunity" was published online in the journal Movement Disorders on November 24, 2021 (DOI:  10/1002/mds.28858).

    The publication analyzes the role of both c-Abl, a non-receptor tyrosine kinase, as well as misfolded alpha-synuclein in the initiation and progression of Parkinson's disease (PD). Early research in PD hypothesized that misfolded alpha-synuclein was the primary driver in initiating the disease process. However, novel humanized preclinical mouse models of progressive, alpha-synuclein-dependent disease, indicate that while the presence of misfolded alpha-synuclein is necessary, it is not sufficient to initiate the disease. The internalization of misfolded alpha-synuclein within the affected neurons activates c-Abl, which in turns modifies the internalized misfolded protein to create a toxic form of alpha-synuclein and triggering effectors that drive the neurodegenerative disease processes. Therapeutic administration of IkT-148009, a highly selective c-Abl kinase inhibitor, demonstrated the ability to clear alpha-synuclein aggregates from the brain and GI tract, promote regeneration of neurons, and induce substantial functional recovery in measures of motor and non-motor function. These studies support that the inhibition of c-Abl could have disease modifying effects and further support the continued clinical development of IkT-148009.

    "Parkinson's disease affects an estimated one million people in the U.S. and remains a significant unmet medical need. Today's publication provides a detailed mechanistic understanding of the early steps in the disease process and the role c-Abl plays in neurodegeneration. Our lead candidate, IkT-148009, a selective c-Abl kinase inhibitor, has demonstrated the potential to halt and reverse disease progression in animal models," stated Milton H. Werner, Ph.D., President and Chief Executive Officer of Inhibikase Therapeutics and principal author of the manuscript published today along with co-author and Interim Chief Medical Officer Dr. Warren Olanow. "IkT-148009 is currently in a Phase 1b extension study in Parkinson's patients, which we believe will give us an early look into safety and tolerability of IkT-148009 in patients and evaluate potential improvements across motor and non-motor aspects of the disease in patients over 7-day dosing. We anticipate completing this extension study in 2022, and expect to present data from our Phase 1 and possibly Phase 1b studies at the AD-PD Meeting to be held March 15-20, 2022 in Barcelona, Spain."

    About IkT-148009

    IkT-148009 is a selective c-Abl kinase inhibitor that uniquely inhibits c-Abl and the closely related Abl2/Arg enzyme without inhibition of other members of the Abl-kinase family, namely c-Kit or PDGFRa/b. It has nearly 20x the potency of the anticancer agent Imatinib against c-Abl in enzyme inhibition assays. The extension of the Company's Phase 1 study into the patient population, a Phase 1b, will focus on safety, tolerability and pharmacokinetics measured over 7 to 14 days.  Following Agency review of 13-week pivotal toxicology data discussed herein and depending on agreement with the U.S. FDA on the clinical path going forward, the Company plans to initiate a Phase 2a study and dose up to 120 patients for up to 3 months of daily dosing at three different doses. Cognitive, motor function and gut motility tests will all be assessed as exploratory endpoints in these Phase 1b and Phase 2a studies, to include measures of alpha-synuclein aggregate clearance in multiple tissues and/or fluids as a consequence of treatment.

    About Parkinson's Disease

    Parkinson's disease (PD) is the second most prevalent neurodegenerative disorder, affecting approximately 1,000,000 persons in the United States, with 60,000 new cases and 38,000 deaths annually. PD is a progressive neurodegenerative disease that initiates with misfolding of a small, non-essential protein known as alpha-synuclein inside and outside of the brain. The common features of PD include tremors at a resting state, slowing or lack of control of movement and postural instability. These features of the disease arise from degeneration of neurons that secrete dopamine to transmit neurological signals. The degeneration of these dopaminergic neurons in nigrostriatal area of the brain near the brainstem, coupled with the accumulation of alpha-synuclein protein aggregates in cell bodies and terminals known as Lewy bodies, have long been thought to be the cause of the disease. Less well known are the features of this disease can affect serotonin levels, cholinergic, and norepinephrine neurons and nerve cells in the olfactory system, cerebral hemisphere, brain stem, spinal cord, and peripheral autonomic nervous system such as in the GI tract. Currently, these non-dopaminergic features are not properly controlled with dopamine-replacement or levodopa therapy.

    About Inhibikase

    Inhibikase Therapeutics, Inc. (NASDAQ:IKT) is a clinical-stage pharmaceutical company developing therapeutics for Parkinson's disease and related disorders. Inhibikase's multi-therapeutic pipeline focuses on neurodegeneration and its lead program IkT-148009, an Abelson Tyrosine Kinase (c-Abl) inhibitor, targets the treatment of Parkinson's disease inside and outside the brain. Inhibikase is currently evaluating the safety, tolerability and pharmacokinetics of IkT-148009 in older and elderly healthy subjects and Parkinson's patients. Its multi-therapeutic pipeline is pursuing Parkinson's-related disorders of the brain and GI tract, orphan indications related to Parkinson's disease such as Multiple System Atrophy, or MSA, and drug delivery technologies for kinase inhibitors such as IkT-001Pro, a prodrug of the anticancer agent Imatinib that the Company believes will provide a better patient experience with fewer on-dosing side-effects. The Company's RAMPTM medicinal chemistry program has identified a number of follow-on compounds to IkT-148009 to be applied to other cognitive and motor function diseases of the brain. Inhibikase is headquartered in Atlanta, Georgia with offices in Boston, Massachusetts.

    Social Media Disclaimer

    Investors and others should note that we announce material financial information to our investors using our investor relations website, press releases, SEC filings and public conference calls and webcasts. The company intends to also use Twitter, 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 are set forth in Inhibikase's filings with the SEC, including its registration statement on Form S-1, as amended (File No. 333-240036), including under the caption "Risk Factors." 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.

     

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  3. BOSTON and ATLANTA, Nov. 15, 2021 /PRNewswire/ -- Inhibikase Therapeutics, Inc. (NASDAQ:IKT) (Inhibikase), a clinical-stage pharmaceutical company developing therapeutics to modify the course of Parkinson's disease and related disorders, today reported financial results for the third quarter ended September 30, 2021 and highlighted recent developments.

    Key Business and Clinical Highlights

    • Dosed first patient in the Phase 1b clinical trial of IkT-148009: In October 2021 Inhibikase dosed the first patient in its Phase 1b clinical trial of IkT-148009, a randomized, placebo-controlled trial to evaluate the safety, tolerability, and pharmacokinetics of IkT-148009. The trial will enroll a total of 24 patients with Parkinson's disease and also assess non-motor and motor function, gut motility, and measures of alpha-synuclein aggregate clearance, as exploratory endpoints. The Company expects to complete this study and, with the approval of the U.S. Food and Drug Administration (FDA), advance into a Phase 2a study in 2022.
    • Extended Phase 1 clinical trial of IkT-148009 to higher doses: In October 2021, Inhibikase expanded dosing of IkT-148009 in older and elderly healthy volunteers up to a single 250 mg dose to identify the maximum tolerated dose. This extension was based on the safety and tolerability profile observed in the initial dose cohorts of the Phase 1 study.
    • Submitted interim three-month results from chronic toxicology studies of IkT-148009 to FDA: In October 2021, Inhibikase reported that it had submitted interim three-month results from its ongoing chronic toxicology studies of IkT-148009 in rats and non-human primates to the FDA. Data indicated that the toxicology profile of IkT-148009 improves with extended daily oral dosing and supports evaluation in Parkinson's patients for up to three months.
    • Received grant from U.S. National Institutes of Health to evaluate IkT-148009 for the treatment of Multiple System Atrophy: In September 2021, Inhibikase was awarded a research grant from the U.S. National Institute of Neurological Disease and Stroke (NINDS), an Institute of the National Institutes of Health (NIH), to evaluate the mechanism of the MSA disease process and the therapeutic potential of IkT-148009 in preclinical studies.

    "Over the past quarter, we have worked diligently to advance our lead candidate, IkT-148009 in multiple indications. We dosed the first Parkinson's patient in our Phase 1b study as well as submitted interim chronic toxicology data to the FDA to support extended dosing of IkT-148009. We were also pleased to receive a grant from the NIH to evaluate IkT-148009 in a novel preclinical model of MSA, a neurodegenerative disease that may benefit from c-Abl inhibition," commented Milton Werner, Ph.D., President and Chief Executive Officer of Inhibikase. "As we look ahead, we expect to file our IND application for IkT-001Pro for the treatment of CML in the first quarter of 2022 as well as anticipate completing our Phase 1b study for Ikt-148009 in 2022."

    Third Quarter Financial Results

    Net Loss: Net loss for the quarter ended September 30, 2021, was $4.5 million, or $0.18 per share, compared to a net loss of $0.7 million, or $0.08 per share in the third quarter 2020.

    R&D Expenses: Research and development expenses were $3.2 million for the quarter ended September 30, 2021 compared to $.1 million in the third quarter 2020. The increase was driven by a $0.3 million increase in grant related research expenditures and a $2.8 million increase in non-grant related research.  The non-grant related research was expended primarily in connection with the Company's Phase I Parkinson's disease clinical trial. 

    SG&A Expenses: Selling, general and administrative expenses for the quarter ended September 30, 2021 were $1.6 million compared to $0.6 million for the third quarter in 2020. The increase was the result of increased non-cash stock compensation expense of $0.1 million, increased director and officer's liability insurance of $0.4 million related to the Company's IPO in December 2020, increased legal fees, board fees, investor relation and consulting fees of $0.3 million relating to operating as a public company registrant since December 2020 and a net increase of $0.2 million for other normal operating expenses.

    Cash Position: Cash and cash equivalents were $45 million as of September 30, 2021.

    About Inhibikase (www.inhibikase.com)

    Inhibikase Therapeutics, Inc. (NASDAQ:IKT) is a clinical-stage pharmaceutical company developing therapeutics for Parkinson's disease and related disorders. Inhibikase's multi-therapeutic pipeline focuses on neurodegeneration and its lead program IkT-148009, an Abelson Tyrosine Kinase (c-Abl) inhibitor, targets the treatment of Parkinson's disease inside and outside the brain. Inhibikase has completed its planned Phase 1 studies evaluating the safety, tolerability and pharmacokinetics of IkT-148009 in older and healthy subjects and has commenced a Phase 1b study in Parkinson's patients. The company has further extended the Phase 1 older and elderly healthy volunteer study to explore the maximum tolerated dose further given the favorable adverse event profile seen to date.  Its multi-therapeutic pipeline is pursuing Parkinson's-related disorders of the brain and GI tract, orphan indications related to Parkinson's disease such as Multiple System Atrophy, or MSA, and drug delivery technologies for kinase inhibitors such as IkT-001Pro, a prodrug of the anticancer agent Imatinib 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 a number of follow-on compounds to IkT-148009 to be applied to other cognitive and motor function diseases of the brain. Inhibikase is headquartered in Atlanta, Georgia with offices in Boston, Massachusetts.

    Social Media Disclaimer

    Investors and others should note that we announce material financial information to our investors using our investor relations website, press releases, SEC filings and public conference calls and webcasts. The company intends to also use  TwitterFacebookLinkedIn 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 are set forth in Inhibikase's filings with the SEC, including its registration statement on Form S-1, as amended (File No. 333-240036), including under the caption "Risk Factors." 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.

    # # #

    Inhibikase Therapeutics, Inc.

    Condensed Balance Sheets







    September 30,

    2021





    December 31,

    2020







    (unaudited)









    Assets













    Current assets:













    Cash



    $

    44,845,950





    $

    13,953,513



    Grants receivable





    217,482









    Prepaid research and development





    264,381







    774,356



    Prepaid expenses and other current assets





    541,388







    54,837



    Total assets



    $

    45,869,201





    $

    14,782,706



    Liabilities and stockholders' equity













    Current liabilities:













    Accounts payable



    $

    553,801





    $

    1,720,680



    Accrued expenses and other current liabilities





    1,905,010







    632,934



    Deferred revenue











    2,325,741



    Notes payable





    248,911







    42,534



    Total





    2,707,722







    4,721,889



    Notes payable, net of current portion











    276,461



    Total liabilities





    2,707,722







    4,998,350



    Commitments and contingencies (see Note 11)













    Stockholders' equity:













    Preferred stock, $0.001 par value; 10,000,000 shares authorized at September 30, 2021 and December 31, 2020; 0 shares issued and outstanding at September 30, 2021 and December 31, 2020













    Common stock, $0.001 par value; 100,000,000 and 30,000,000 shares authorized;  25,155,198 and 10,050,849 shares issued and outstanding at September 30, 2021 and December 31, 2020, respectively.





    25,155







    10,051



    Additional paid-in capital





    67,912,392







    24,805,929



    Accumulated deficit





    (24,776,068)







    (15,031,624)



    Total





    43,161,479







    9,784,356



    Total liabilities and stockholders' equity



    $

    45,869,201





    $

    14,782,706



     

    Inhibikase Therapeutics, Inc.

    Condensed Statements of Operations

    (Unaudited)







    Three Months Ended

    September 30,





    Nine Months Ended

    September 30,







    2021





    2020





    2021





    2020



    Revenue:

























    Grant revenue



    $

    328,459





    $

    37,680





    $

    3,098,661





    $

    528,052



    Total revenue





    328,459







    37,680







    3,098,661







    528,052



    Costs and expenses:

























    Research and development





    3,154,553







    120,569







    7,968,846







    666,858



    Selling, general and administrative





    1,644,946







    580,820







    4,854,494







    1,478,839



    Total costs and expenses





    4,799,499







    701,389







    12,823,340







    2,145,697



    Loss from operations





    (4,471,040)







    (663,709)







    (9,724,679)







    (1,617,645)



    Interest expense





    (157)







    (6,890)







    (19,765)







    (22,263)



    Net loss



    $

    (4,471,197)





    $

    (670,599)





    $

    (9,744,444)





    $

    (1,639,908)



    Net loss per share – basic and diluted



    $

    (0.18)





    $

    (0.08)





    $

    (0.61)





    $

    (0.20)



    Weighted-average number of common shares – basic and diluted





    25,143,559







    8,198,754







    15,868,421







    8,187,517



     

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  4. ATLANTA and BOSTON, Oct. 27, 2021 /PRNewswire/ -- Inhibikase Therapeutics, Inc. (NASDAQ:IKT) (Inhibikase), a clinical-stage pharmaceutical company developing therapeutics to modify the course of Parkinson's disease and related disorders, today announced that Dr. Milton Werner, Ph.D., President & Chief Executive Officer of Inhibikase, will participate in the Michael J. Fox Foundation Alpha-Synuclein Summit being held virtually from November 3-4, 2021.

    Dr. Werner will detail the pivotal role of c-Abl in driving neurodegeneration and neuroinflammation in Parkinson's disease (PD) as well as provide a comprehensive biochemical overview of the early stages of the disease process. During the presentation, Dr. Werner will also highlight data from pre-clinical and clinical studies of IkT-148009, which further validate the role of c-Abl in the progression of PD and support the continued clinical development of IkT-148009 as a novel treatment option. After the presentation, Dr. Werner will participate on an expert panel to discuss the various strategies now being pursued in the clinic to modulate pathological alpha-synuclein in patients. 

    Michael J. Fox Foundation Alpha-Synuclein Summit:

    Presentation: Functional recovery and clearance of alpha-synuclein toxicity following therapeutic administration of the oral c-Abl inhibitor IkT-148009

    Date: Wednesday, November 3, 2021

    Time: 12:25pm ET

    Panel Discussion

    Date: Wednesday, November 3, 2021

    Time: 12:35pm ET

    About Inhibikase (www.inhibikase.com

    Inhibikase Therapeutics, Inc. (NASDAQ:IKT) is a clinical-stage pharmaceutical company developing therapeutics for Parkinson's disease and related disorders. Inhibikase's multi-therapeutic pipeline focuses on neurodegeneration and its lead program IkT-148009, an Abelson Tyrosine Kinase (c-Abl) inhibitor, targets the treatment of Parkinson's disease inside and outside the brain. Inhibikase has completed its Phase 1 studies evaluating the safety, tolerability and pharmacokinetics of IkT-148009 in older and healthy subjects and has commenced a Phase 1b study in Parkinson's patients. Its multi-therapeutic pipeline is pursuing Parkinson's-related disorders of the brain and GI tract, orphan indications related to Parkinson's disease such as Multiple System Atrophy, or MSA, and drug delivery technologies for kinase inhibitors such as IkT-001Pro, a prodrug of the anticancer agent Imatinib 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 a number of follow-on compounds to IkT-148009 to be applied to other cognitive and motor function diseases of the brain. Inhibikase is headquartered in Atlanta, Georgia with offices in Boston, Massachusetts.

    Social Media Disclaimer

    Investors and others should note that we announce material financial information to our investors using our investor relations website, press releases, SEC filings and public conference calls and webcasts. The company intends to also use Twitter, 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 are set forth in Inhibikase's filings with the SEC, including its registration statement on Form S-1, as amended (File No. 333-240036), including under the caption "Risk Factors." 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.

     

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  5. ATLANTA, Oct. 19, 2021 /PRNewswire/ -- Inhibikase Therapeutics, Inc. (NASDAQ:IKT) (Inhibikase), a clinical-stage pharmaceutical company developing therapeutics to modify the course of Parkinson's disease and related disorders, today announced dosing of the first Parkinson's patient in its Phase 1b clinical trial of IkT-148009, an Abelson Tyrosine Kinase, or c-Abl, inhibitor for the treatment of Parkinson's disease.

    The Phase 1b extension study is a 3:1 randomized, placebo-controlled trial investigating the safety, tolerability and pharmacokinetics of IkT-148009. The trial will enroll a total of 24 patients with Parkinson's disease across 3 escalating doses (8 patients per cohort). The study will also assess cognitive, motor function, gut motility and measures of alpha-synuclein aggregate clearance in multiple compartments, as exploratory endpoints. The Company previously reported results from its Phase 1 study of IkT-148009 in older and elderly healthy volunteers, which achieved high drug exposure between 12.5 and 100 mg with no clinically significant adverse events across 56 patients.  These results were consistent with exposures observed in animal efficacy studies of inherited and sporadic progressive Parkinson's disease.

    "We are pleased to begin dosing patients in our Phase 1b study. This is the first time we will assess our selective c-Abl kinase inhibitor in Parkinson's patients, which could give us an early look into the potential efficacy of this treatment in slowing or possibly halting disease progression and even partly restoring functional loss in Parkinson's disease," commented Milton Werner, Ph.D., President and Chief Executive Officer of Inhibikase Therapeutics. "As we look ahead, we anticipate completing this study and advancing into a Phase 2a study in 2022."

    c-Abl is a clinically validated target that is activated once plaques of alpha-synuclein are internalized by the affected neurons in the brain and gut. C-Abl drives biochemical pathways and processes that lead to degradation of the neurons affected in Parkinson's disease. Inhibition of c-Abl may restore functional loss for neurons that have not fully degraded in the brain and remodel neurons in the gastrointestinal tract, two major organ systems affected by the disease.

    About IkT-148009

    IkT-148009 is a selective c-Abl kinase inhibitor that uniquely inhibits c-Abl and the closely related Abl2/Arg enzyme without inhibition of other members of the Abl-kinase family, namely c-Kit or PDGFRa/b. It has nearly 20x the potency of the anticancer agent Imatinib against c-Abl in enzyme inhibition assays. The extension of the Company's Phase 1 study into the patient population, a Phase 1b, will focus on safety, tolerability and pharmacokinetics measured over 7 to 14 days. The Company reported interim 13-week toxicology study outcomes to the FDA in October, 2021. Following Agency review and agreement, the Company plans to dose patients out to 3 months. Cognitive, motor function and gut motility tests will all be assessed as exploratory endpoints in this Phase 1b study, to include measures of alpha-synuclein aggregate clearance in multiple compartments as a consequence of treatment.

    About Parkinson's Disease

    Parkinson's disease (PD) is the second most prevalent neurodegenerative disorder, affecting approximately 1,000,000 persons in the United States, with 60,000 new cases and 38,000 deaths annually. PD is a progressive neurodegenerative disease that initiates with misfolding of a small, non-essential protein known as alpha-synuclein inside and outside of the brain. The common features of PD include tremors at a resting state, slowing or lack of control of movement and postural instability. These features of the disease arise from degeneration of neurons that secrete dopamine to transmit neurological signals. The degeneration of these dopaminergic neurons in nigrostriatal area of the brain near the brainstem, coupled with the accumulation of alpha-synuclein protein aggregates in cell bodies and terminals known as Lewy bodies, have long been thought to be the cause of the disease. Less well known are the features of this disease can affect serotonin levels, cholinergic, and norepinephrine neurons and nerve cells in the olfactory system, cerebral hemisphere, brain stem, spinal cord, and peripheral autonomic nervous system such as in the GI tract. Currently, these non-dopaminergic features are not properly controlled with dopamine-replacement or levodopa therapy.

    About Inhibikase (www.inhibikase.com)

    Inhibikase Therapeutics, Inc. (NASDAQ:IKT) is a clinical-stage pharmaceutical company developing therapeutics for Parkinson's disease and related disorders. Inhibikase's multi-therapeutic pipeline focuses on neurodegeneration and its lead program IkT-148009, an Abelson Tyrosine Kinase (c-Abl) inhibitor, targets the treatment of Parkinson's disease inside and outside the brain. Inhibikase has completed its Phase 1 studies evaluating the safety, tolerability and pharmacokinetics of IkT-148009 in older and healthy subjects and has commenced a Phase 1b study in Parkinson's patients. Its multi-therapeutic pipeline is pursuing Parkinson's-related disorders of the brain and GI tract, orphan indications related to Parkinson's disease such as Multiple System Atrophy, or MSA, and drug delivery technologies for kinase inhibitors such as IkT-001Pro, a prodrug of the anticancer agent Imatinib 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 a number of follow-on compounds to IkT-148009 to be applied to other cognitive and motor function diseases of the brain. Inhibikase is headquartered in Atlanta, Georgia with offices in Boston, Massachusetts.

    Social Media Disclaimer

    Investors and others should note that we announce material financial information to our investors using our investor relations website, press releases, SEC filings and public conference calls and webcasts. The company intends to also use Twitter, 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 are set forth in Inhibikase's filings with the SEC, including its registration statement on Form S-1, as amended (File No. 333-240036), including under the caption "Risk Factors." 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.

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