On August 12, 2022 Inhibikase Therapeutics, Inc. (Nasdaq: IKT) ("Inhibikase" or "Company"), a clinical-stage pharmaceutical company developing therapeutics with the potential to modify the course of Parkinson’s disease ("PD") and related disorders, reported financial results for the second quarter ended June 30, 2022 and highlighted recent developments (Press release, Inhibikase Therapeutics, AUG 12, 2022, View Source [SID1234618271]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"In the second quarter, we continued to make progress across our entire portfolio. We recently opened enrollment in our Phase 2a ‘201’ trial for IkT-148009 for the treatment of Parkinson’s disease. We have now opened nearly a quarter of all sites for the study and we are actively screening patients. In addition, we have submitted our Investigational New Drug (IND) application for IkT-001Pro for patients with chronic myelogenous leukemia to the U.S. Food and Drug Administration (FDA), and expect to initiate our ‘501’ bioequivalence study of IkT-001Pro following FDA review and concurrence," commented Milton Werner, Ph.D., President and Chief Executive Officer of Inhibikase. "Looking ahead, we also expect to share Parkinson’s assessment data from our Phase 1/1b ‘101’ clinical trial of IkT-148009 at the Movement Disorders Society Congress in September and are continuing to advance our regulatory activities in the U.S. and the EU27 as we plan a Phase 2 trial in Multiple System Atrophy. Taken together, we believe that these activities lay the groundwork for continued momentum across our business as we seek to deliver on our mission of bringing novel, disease-modifying treatments to patients suffering from devastating diseases."

Recent Developments and Upcoming Milestones:

Phase 2a ‘201’ Trial of IkT-148009 Open for Enrollment: In May 2022, Inhibikase opened enrollment for its Phase 2a study (‘201 trial’) evaluating IkT-148009 for the treatment of Parkinson’s disease. The Company has opened 11 of 40 planned sites and is actively screening patients. The 201 trial is a 1:1:1:1 randomized, double-blind, twelve-week dosing trial, designed to measure the safety, tolerability and steady-state pharmacokinetics (PK) of three doses of IkT-148009 in up to 120 untreated Parkinson’s patients. The trial will further measure the potential for IkT-148009 to impact the disease globally in the body using a hierarchy of Parkinson’s-related disease assessments in the brain and gut as secondary or exploratory endpoints.

The advancement of IkT-148009 into Phase 2a followed a review of the study protocol, as well as the safety, tolerability and PK data from the 101 clinical trial by the FDA. In the 101 trial, the clinical pharmacology of IkT-148009 in patients paralleled the clinical pharmacology of IkT-148009 in older heathy volunteers. IkT-148009 also demonstrated a favorable safety and tolerability profile up to a dose of 325 mg, with no clinically-significant adverse events observed. Inhibikase plans to present additional data from the 101 trial at the Movement Disorders Society Congress in Madrid, Spain, in September 2022.

Filed IND Application for IkT-001Pro for Stable-Phase Chronic Myelogenous Leukemia (CML): On June 29, 2022, Inhibikase filed its IND application with the FDA for IkT-001Pro, the Company’s prodrug of imatinib mesylate to treat Stable-phase Chronic Myelogenous Leukemia (SP-CML). A clerical error delayed the review of the IND, however the Division of Hematological Malignancies I confirmed that FDA review of the IND should be completed no later than August 26, 2022. Following clearance by the FDA, the Company expects to initiate bioequivalence studies in accordance with the 505(b)(2) regulatory pathway. IkT-001Pro will be evaluated in a two-part dose finding/dose equivalence study in up to 62 healthy volunteers. The study is designed to evaluate the steady-state pharmacokinetics of IkT-001Pro and determine the dose of IkT-001Pro equivalent to 400 mg imatinib mesylate, the standard-of-care dose for SP-CML. Inhibikase expects to initiate this two-part bioequivalence study in the normal course following review of the proposed clinical study by the FDA. Inhibikase will confer with the FDA once bioequivalence is established to begin the New Drug Application, or NDA, process on the proposed approval path for IkT-001Pro under the 505(b)(2) statute. The Company plans to simultaneously pursue a superiority study comparing the selected dose of IkT-001Pro to standard-of-care 400 mg imatinib mesylate in SP-CML patients using a novel two-period, wait-list-crossover-switching study.

Evaluating ongoing studies of IkT-148009 in Animal Models of Multiple System Atrophy (MSA): Inhibikase continues to advance regulatory activities IkT-148009 in both the U.S. and EU27 for the treatment of MSA. The Company is preparing regulatory filings in the US and EU27 to enable the planned Phase 2 MSA trial if IkT-148009 is validated to be active in MSA in animal model studies. Execution of this trial will require the Company to raise additional working capital. Two animal model studies are ongoing and a preliminary assessment in one of the two studies demonstrated an apparent functional benefit following treatment.

Receipt of new patent # 11,407,747 entitled Compositions and methods for inhibiting kinases: This patent was issued August 9, 2022 for the application of the Company’s c-Abl kinase inhibitor portfolio to the treatment of cancer or bacterial or viral infections. This patent is the fifth U.S. patent issued for our portfolio of compounds that inhibit Abelson Tyrosine Kinases for a therapeutic purpose.
Second Quarter 2022 Financial Results

Net Loss: Net loss for the second quarter ended June 30, 2022, was $4.6 million, or $0.18 per share, compared to a net loss of $ 2.6 million, or $0.22 per share for the second quarter in 2021.

Net loss for the six months ended June 30, 2022, was $9.3 million or $0.37 per share, compared to a net loss of $5.3 million, or $0.47 per share in the six months ended June 30, 2021.

R&D Expenses: Research and development expenses were $3.0 million for the second quarter ended June 30, 2022, compared to $2.4 million in the second quarter of 2021. The increase of $0.6 million was driven by a $2.1 million increase in non-grant related research offset by a decrease of $1.4 million in grant related research expenditures and a decrease of $0.1 million in non-cash stock compensation expense. The non-grant related research was expended primarily in connection with the Company’s PD clinical trials.

Research and development expenses were $6.0 million for the six months ended June 30, 2022 compared to $4.8 million in the comparable period in 2021. The $1.2 million increase was driven by a $4.3 million increase in non-grant related research offset by a decrease of $2.7 million in grant related research expenditures and a decrease of $0.4 million in non-cash stock compensation expense. The non-grant related research was expended primarily in connection with the Company’s PD clinical trials.

SG&A Expenses: Selling, general and administrative expenses for the quarter ended June 30, 2022 were $1.7 million compared to $1.6 million for the second quarter in 2021. The increase was primarily from increased headcount resulting in increased compensation expense of $0.1 million, increased legal fees, board fees, investor relation and consulting fees of $0.3 million and a net increase of $0.1 million for other normal operating expenses offset by decreased non-cash stock based compensation expense of $0.4 million.

Selling, general and administrative expenses for the six months ended June 30, 2022 were $3.3 million compared to $3.2 million for comparable period in 2021. The increase was primarily from increased headcount resulting in increased compensation expense of $0.3 million, increased legal fees, board fees, investor relation and consulting fees of $0.6 million and a net decrease of $0.1 million for other normal operating expenses offset by decreased non-cash stock based compensation expense of $0.7 million.

Cash Position: Cash and cash equivalents were $32.2 million as of June 30, 2022. The Company expects that existing cash and cash equivalents will be sufficient to fund its normal operations and capital expenditure requirements through December 31, 2023.

Conference Call Information
The conference call is scheduled to begin at 8:00am ET on Monday, August 15, 2022. Participants should dial 844-825-9789 (United States) or 412-317-5180 (International) with the conference code 10169366. A live webcast may be accessed using the link here, or by visiting the investors section of the Company’s website at www.inhibikase.com. After the live webcast, the event will be archived on Inhibikase’s website for approximately 90 days after the call.