Inhibikase Therapeutics, Inc.

Good morning. Welcome to the Inhibit Case Therapeutic Second Quarter 2023 Financial Results Conference Call. All participants will be in listen only mode. Should you need assistance, please signal a conference specialist by pressing star then zero on your telephone keypad. After today's presentation, there will be an opportunity to ask questions. To ask a question, you may press star then one on your telephone keypad. To withdraw your question, please press star then two. Please note this event is being recorded. I would now like to turn the conference over to Alex Lobo, Stern Investor Relations. Please go ahead.

Good morning and welcome to the Navigate Therapeutics second quarter of 2023 financial results conference call and audio webcast. With me today is Dr. Milton Werner, chief executive officer, chief financial officer. On Monday, August 14, 2023, Inhibit Case issued a press release announcing financial results for the second quarter ended June 30, 2023. We encourage everyone to read yesterday's press release, as well as Inhibit Case's quarterly report on Form 10-Q, which has been filed with the SEC. The company's press release and quarterly report are also available on Inhibit Case's website at inhibitcase.com. In addition, this conference call is being webcast through the investor relations section of the company's website and will be archived there for future reference. Please note that certain information discussed on today's call is covered under the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Participants are cautioned that this conference call contains time sensitive information that is accurate only as of the date of this live broadcast, August 15th, 2023. Actual results could differ materially from those stated or implied by these forward-looking statements due to risks and uncertainties associated with the company's business. Information on potential risks and uncertainties are set forth in our most recent public filing with the SEC at sec.gov. The company undertakes no obligation to revise or update any forward-looking statements to reflect events or circumstances after the date of this webcast, except as may be required by applicable securities law. With that said, I would now like to turn the call over to Dr. Milton Werner. Milton, you may begin.

Thank you, Alex, and thank you, everyone, for joining us today for Inhibit Case Therapeutics' second quarter 2023 earnings call. We are pleased with the progress we have made across our clinical programs in the first half of this year. Our Phase II 201 trial using IKT148009 to treat Parkinson's disease is screening and enrolling patients across 22 of up to 35 planned sites with the first patient of weak dosing regimen. Additionally, this quarter, we launched a public awareness campaign through the 201trial.com that we believe will enable us to continue to drive enrollment in the trial. The trial website is being augmented with outreach to patient advocacy groups, caregiver networks, foundations, and social media advertising throughout the United States. In June, we completed the pivotal phase of the 501 trial evaluating bioequivalence between IKT-001-pro, commercial 400-milligram imatinib mesylate. Following agreements with the FDA, we are contemplating to evaluate the bioequivalent dose between IKT-001-pro and high-dose 600-milligram imatinib mesylate to further explore the potential safety benefits of IKT-01-pro delivery of imatinib. High-dose imatinibesylate is in common use for the treatment of CML, but poorly tolerated by most patients, a shortcoming that IKT-001-PRO may overcome. We plan to release a full data description for the pivotal phase of our 501 trial in the near term. Upon completion of the study, we plan on engaging the FDA to discuss the parameters of drug approval under the 505b2 regulatory pathway. In addition to these clinical accomplishments, we continue to expand our expertise in drug delivery, not only with IKT001 Pro, but also now with IKT148009. The development of a commercial tablet formulation of IKT148009 has nearly doubled the efficiency of drug delivery for IKT148009 providing the opportunity to lower the therapeutic dose and improve safety, as well as consistently deliver the dose each and every day to ensure a continuous therapeutic benefit from one's daily dosing. Before I turn the call over to Joe to review our financial results, I would like to touch on our preclinical efforts and other neurodegenerative diseases. Multiple system atrophy, or MSA, is a rare Parkinson's-related disease that is a rapidly progressive neurodegenerative movement disorder of the central and autonomic nervous systems. Currently, we are evaluating MSA in two models, one that measures the ability of IKT148009 to block progression early in the course of MSA, and a second model that evaluates the therapeutic potential to correct functional loss and neurodegeneration late in the course of the disease. The first MSA model study is nearing completion and has demonstrated that treatment with IKT148009 for 20 weeks prevented functional loss and preserved neural anatomy in mice when IKT148009 is given orally once daily. Functional benefit in this model was accomplished by substantial reduction in the underlying opacific pathology. Evaluation of the effect of IKT148009 when treatment begins late in the course of the disease remains ongoing, and we expect to complete that study by the end of 2023. These studies will form the basis of our planned Phase II clinical study of IKT148009 in MSA. We look forward to providing further updates on these studies and potential timing of the planned Phase II trial in the coming quarters. I will now turn it over to our Chief Financial Officer, Joe Fratelloli, to review our financial results for the quarter.