IKT - NASDAQ

Greetings, welcome to Inhibikase Therapeutics’ Fourth Quarter Full Year 2021 Financial Results. At this time, all participants are in listen only mode. A question-and-answer session will follow the formal presentation. Please note this conference is being recorded. At this time I'll now turn the conference over to Alexander Lobo with Stern Investor Relations. Alexander, you may now begin.

Good morning and welcome to Inhibikase Therapeutics Full Year 2021 Financial Results Conference Call and Audio Webcast. With me today are Dr. Milton Werner, Chief Executive Officer and Joseph Frattaroli, Chief Financial Officer. Yesterday afternoon Inhibikase Therapeutics issued a press release announcing financial results for the full year ended December 31st, 2021. We encourage everyone to read yesterday's press release as well as Inhibikase’s annual reports on form 10-K for the full year 2021, which is being filed with the SEC. The company's press release and annual report are also available on Inhibikase’s website at inhibikase.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, April 1st, 2022. 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 filings 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?

Thank you, Alex and welcome everyone to Inhibikase Therapeutics’ full year 2021 earnings call. 2021 was a really important year for us as we transitioned into a clinical stage company that has made significant progress in a very short period of time. We've advanced our lead program IkT-148009 for Parkinson's disease into the clinic and rapidly moved from dosing healthy volunteers in a Phase 1 study into dosing patients with mild to moderately advanced Parkinson's disease in our Phase 1B extension study. Just recently, we presented results from both of these studies at the annual AD/PD meeting in Barcelona, Spain. I will talk a little bit more about these results later on, but in short, we believe these data continue to validate the safety of therapeutic potential of IkT-148009. In our early stage pipeline, we have continued to make progress in advancing IKT-148009 in animal models of multiple system atrophy, as well as IkT-001Pro towards an IND filing. We expect to provide further updates on both programs in the second quarter. Lastly to support all of these efforts, we were pleased to strengthen our balance sheet last year to support our development efforts well into 2023. Taken together, we believe that all of these efforts position us for a year of execution on the pipeline as we seek to improve the lives of patients and create value for our shareholders. Let me start by highlighting the progress we've made in our lead program IKT-148009. As many of you know, IKT-148009 is a highly selective non-receptor abelson tyrosine kinase, or c-Abl inhibitor. Tyrosine kinase inhibitors have a 25 year history of clinical use. However, only a few Tyrosine Kinase inhibitors have been approved for non-oncology indications. Drugs in the Abl Tyrosine Kinase inhibitor class generally cannot reach a therapeutic dose in the central nervous system. IKT-148009 is different in this regard as we designed the molecule to have a predicted low toxicity profile and to have the ability to cross the blood and brain barrier and accumulate in the brain, features that were well -- that were validated in animal models and extensive toxicology studies. Our randomized Phase 1 dose escalation study in older and elderly healthy volunteers continues to evaluate the safety, tolerability, and pharmacokinetics of IKT-148009. The primary objective of study has been to identify by the maximum tolerated dose and PK profile in single and multiple setting dose settings. The study, which was initiated in February of 2021, has demonstrated exposures that are very high. For example covering an area under the curve or AUC that is greater than 200,000 nanogram hour per milliliter at a 320 milligram dose, given once daily, and displays linear dose proportionality in the blood. There have been no clinically significant adverse events observed across 88 subjects in single or seven day dosing experiments up to a 325 milligram dose. Penetration into the central nervous system was confirmed by measures of IKT-148009 in spinal fluid. Turning now to the Phase 1B extension study, which is a 3:1 randomized placebo controlled dose escalation trial with seven day dosing. This portion of the study is evaluating the safety, tolerability and pharmacokinetics of seven day dosing of IKT-148009 at three escalating dose levels in patients with mild to moderately advanced Parkinson disease. The study is also assessing motor and non-motor function and have gut motility and plans to measure alpha-synuclein aggregate clearance as exploratory endpoints. In the first cohort that has been enrolled and analyzed, there were no clinically significant adverse events observed. One case of pneumonia. One case of spinal headache following -- spinal fluid sampling. And one case of dermatitis, were all that was observed in the eight patient cohort. Clinical pharmacology of IKT-148009 in patients closely paralleled to clinical pharmacology of IKT-148009 in older healthy volunteers. Trends and changes in motor and non-motor features of the disease are observed, but cannot be presently interpreted from a short dosing duration of just eight patients. This early results are encouraging and we look forward to completing Cohorts two and three in the study. Taken together, we believe these promising results from both the Phase 1 and Phase 1b studies continue to validate the safety and therapeutic potential of IkT-148009 as a disease modifying treatment of Parkinson's and stage the design and initiation of the Phase 2a program. Looking ahead, we are working diligently to initiate our Phase 2a clinical study. The study will be a 3:1 randomized double blind 12 week doses in trial that will evaluate the safety and tolerability of three doses of IkT-148009 in up to 120 patients diagnosed with Parkinson Disease, who've not yet progressed to the need for symptomatic treatment. The trial will also measure motor non-motor function inside and outside of the brain as secondary endpoints, as well as evaluate whether IkT-148009 leads to a reduction or clearance of pathogenic alpha-synuclein aggregates as exploratory endpoints. We expect to initiate and dose the first patients in the second quarter of 2022 subject to agreements with the FDA. Before I turn call to Joe to review your financials, I wanted to touch a couple of our early stage programs. As we seek to broadly apply our learnings of neurodegeneration beyond Parkinson Disease, we are currently evaluating IkT-148009 in animal models of Multiple System Atrophy or MSA. This work is part of the grant that we receive from the US National Institutes of Neurological Disease and Stroke, and National Institutes of Health in 2021. MSA is a rare, rapidly progressing neurodegenerative movement disorder that affects both essential and autonomic nervous systems. Similar to Parkinson's, MSA is characterized by pathological alpha-synuclein aggregation. This may lead to cell dysfunction and degeneration of neurons. MSA affects approximately 20,000 people in the US, and there are currently no approved therapies to slow or halt progression of this disease. Our preclinical studies are evaluating whether in addition of c-Abl could have a therapeutic benefit in MSA. And we have previously published a mechanistic paper on the potential role of c-Abl in the disease in the peer reviewed journal Neurobiology of Disease, that publication occurred in 2021. Depending on the preclinical results in animal models of MSA and subjects to agreement with the FDA and equivalent regulatory bodies in the European Union, we may advance IkT-148009 into a Phase 2a clinical study in the third quarter of 2022. But that advancement will only occur if we see positive therapeutic benefit of IkT-148009 in at least one animal model. Finally, we are continuing to advance IkT-001Pro, our prodrug formulation of Imatinib Mesylate, which we’ve designed as a potentially safer, better tolerated treatment for Imatinib-sensitive cancers such as stable-phase Chronic Myeloid Leukemia. We are in the process of collecting stability data for the manufactured product, and now expect to submit the investigational new drug application in the second quarter of 2022. Following the receipt of the study it may proceed later and other agreements with the FDA, we intend to commence final pivotal studies in accordance with the 505(b)(2) regulatory pathway. Now, let me turn the call over to Joe Frattaroli our Chief Financial Officer. Joe?

Thank you, Milton. Let me review our financials for the year ended December 31, 2021. Grant revenue was $3.1 million for the year ended December 31, 2021 compared to $0.7 million to for fiscal year 2020, an increases of approximately 343%. During 2020, the Company’s focus was shifted towards advancing its Phase 1 clinical trial plans, which could not result in grant revenue. During 2021, utilizing the additional capital resources from our June, 2021 follow-on offering, we were able to focus on our clinical trial activities in addition to our grant related research activities. Research and development expenses were at $11.4 million for the year ended December 31, 2021, compared to 0.9 million for the year end 2020, an increase of approximately 1,167%. The significant increase from fiscal ‘21 was primarily due to an $8 million increase in non-grant related research conducted as we ramped up our ongoing human clinical trials. Our grant related research activities also increased during fiscal 2021 by approximately 2.4 million over the prior year. Selling, general & administrative expenses were at 6.5 million for the year ended December 31, 2021, compared to 2.6 million for the same period 2020, an increase of approximately 150%. The significant increase with fiscal '21 was primarily due to ordinary general and administrative costs incurred during our first full year of operating as a public company after our December 2020 initial public offering. For the year ended December 31, 2021, we reported a net loss of approximately $14.8 million or $0.81 per share, compared to a net loss of approximately $2.8 million, or $0.35 per share for the full year 2020. As of December 31, 2021, Inhibikase had approximately 40.8 million in cash. The company anticipates its cash runway will be sufficient to fund operations into the third quarter of 2023. That concludes our financial statements. I'd like to hand the call back over to Milton for closing remarks.

I'd like to conclude by saying that we are very excited by the work we're doing and believe that we have an opportunity to significantly improve the lives of patients suffering from devastating neurodegenerative diseases such as Parkinson's. As we look ahead, we intend to share more about our development strategy and recently presented data for IkT-148009 including the upcoming Phase 2a study at our virtual KOL investor event, which will take place on April 20. We view 2022 as a year of execution across all of our clinical and preclinical pipeline programs and look forward to providing updates throughout the year. We'd like to thank you and our shareholders and partners for their continued support, and I would now like to open the call the questions. Operator?