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spk05: Greetings. Welcome to Inhibit Case 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. If anyone should require operator assistance during the conference, please press star zero from your telephone keypad. Please note, this conference is being recorded. At this time, I'll now turn the conference over to Alexander Lobo with CERN Investor Relations. Alexander, you may now begin.
spk00: Good morning, and welcome to Inhibitase Therapeutics' full year 2021 financial results conference call and audio webcast. With me today are Dr. Milton Werner, Chief Executive Officer, and Joseph Frateroli, Chief Financial Officer. Yesterday afternoon, Inhibitase 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 Inhibitase's annual report on Form 10-K for the full year of 2021, which has been filed with the SEC. The company's press release and annual 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, 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?
spk01: Thank you, Alex, and welcome, everyone, to Inhibicase 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 14809 for Parkinson's disease, into the clinic and rapidly moved from dosing healthy volunteers in a phase one 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 ADPD 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 and therapeutic potential of IKT-4109. In our early stage pipeline, we have continued to make progress in advancing IKT-4109 in animal models of multiple system atrophy, as well as IKT-001-PRO 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 in 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 14809. As many of you know, IKT-1409 is a highly selective, non-receptor, ablesome tyrosine kinase or C-able 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 able tyrosine kinase inhibitor class generally cannot reach a therapeutic dose in the central nervous system. IKT-1409 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-brain barrier and accumulate in the brain, features that were validated in animal models and extensive toxicology studies. Our randomized Phase I dose escalation study in older and elderly healthy volunteers continues to evaluate the safety, tolerability, and pharmacokinetics of IKT-14809. The primary objective of the study has been to identify 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 325 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, 14809, and spinal fluid. Turning now to the Phase 1B extension study, which is a three-to-one 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, 14809 at three escalating dose levels in patients with mild to moderately advanced Parkinson's disease. The study is also assessing motor and non-motor function of gut motility and plans to measure alpha-cyclic and 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 IKT14809 in patients closely parallel the clinical pharmacology of IKT14809 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. These early results are encouraging, and we look forward to completing cohorts two and three in the study. Taking together, we believe these promising results from both the Phase I and Phase IB studies continue to validate the safety and therapeutic potential of IKT4809 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-to-1 randomized, double-blind, 12-week dosing trial that will evaluate the safety and tolerability of three doses of IKT4809 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, as well as evaluate whether IKT14809 leads to a reduction or clearance of pathogenic alpha-synuclein aggregates as exploratory endpoints. We expect to initiate and dose the first patient in the second quarter of 2022, subject to agreements with the FDA. Before I turn the call over to Joe to review our financials, I want to touch a couple of our early stage programs. As we seek to broadly apply our learnings of neurodegeneration beyond Parkinson's disease, we are currently evaluating IKT1489 in animal models of multiple system atrophy, or MSA. This work is part of a grant that we received from the U.S. National Institutes of Neurological Disease and Stroke and Institute of the National Institutes of Health in 2021. MSA is a rare, rapidly progressing neurodegenerative neurodegenerative movement disorder that affects both the central and autonomic nervous systems. Similar to Parkinson's, MSA is characterized by pathological alpha-cytical in aggregation. This may lead to cell dysfunction and degeneration of neurons. MSA affects approximately 20,000 people in the U.S., and there are currently no approved therapies to slow or halt progression of this disease. Our preclinical studies are evaluating whether inhibition of C-ABL could have a therapeutic benefit in MSA. and we have previously published a mechanistic paper on the potential role of C. abel 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 14809 into a Phase IIa clinical study in the third quarter of 2022. But that advancement will only occur if we see positive therapeutic benefits of IKT-1409 in at least one animal model. Finally, we are continuing to advance IKT-001-PRO, our pro-drug formulation of imatinib mesylate, which we have 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 receipt of the study may proceed letter and other agreements with the FDA, we intend to commence bioequivalent studies in accordance with the 505 regulatory pathway. Now let me turn the call over to Joe Frateroli, our Chief Financial Officer. Joe?
spk02: Thank you, Milton. Let me review our financials for the year ended December 31, 2021. Rent revenue was $3.1 million for the year ended December 31, 2021, compared to $0.7 million for fiscal year 2020. an increase of approximately 343%. During 2020, the company's focus was shifted towards advancing its phase one clinical trial plans, which did not result in any grant revenue. During 2021, utilizing the additional capital resources from our June 2021 fall one offering, we were able to focus on our clinical trial activities in addition to our grant-related research activities. Research and development expenses were 11.4 million for the year ended December 31, 2021 compared to 0.9 million for the year end 2020, an increase of approximately 1167%. The significant increase for 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. Grant related research activities also increased during fiscal 2021 by approximately $2.4 million over the prior year. Selling general and administrative expenses were $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 for 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 81 cents per share compared to a net loss of approximately $2.8 million or 35 cents per share for the full year 2020. As of December 31, 2021, Inhibitcase 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.
spk01: Thank you, Joe. I'd like to conclude by saying that we are very excited by the work we are 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 14809, including the upcoming Phase 2A study at our virtual KOL investor event, which will take place on April 20th. 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 to questions. Operator?
spk05: Thank you. We'll now begin the question and answer session. If you'd like to ask a question, please press star 1 from your telephone keypad and the confirmation tone will indicate your line is in the question queue. You may press star 2 if you'd like to remove your question from the queue. For participants using speaker equipment, it may be necessary to pick up your handset before pressing the star keys.
spk04: One moment please while we poll for questions.
spk05: Once again, if you'd like to ask a question this morning, you may press star 1 to enter the queue.
spk03: We'll pause for a few moments to assemble the queue. Thank you. This will conclude today's conference. We thank you for your participation.
spk05: You may now disconnect at this time and have a wonderful day.
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