IKT - NASDAQ

Good day, and welcome to Inhibikase Therapeutics’ Second Quarter 2022 Financial Results Conference Call. All participants are in listen-only mode. [Operator Instructions] Please note, this event is being recorded. I would now turn the conference over to Alex Lobo, Stern Investor Relations. Please go ahead.

Thank you. Good morning, and welcome to Inhibikase Therapeutics second quarter 2022 financial results conference call and audio webcast. With me today is Dr. Milton Werner, Chief Executive Officer; and Joseph Frattaroli, Chief Financial Officer. On Friday, Inhibikase issued a press release announcing financial results for the second quarter ended June 30, 2022. We encourage everyone to read Friday’s press release, as well as Inhibikase’s quarterly report on Form 10-Q for the second quarter 2022, which has been filed with the SEC. The company's press release and quarterly 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, August 15, 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, you may begin.

Thank you, Alex, and thank you, everyone, for joining the call this morning. I want to thank you for joining us today to review Inhibikase’s second quarter financial results and recent business updates. At Inhibikase, we are focused on reversing the effects of neurodegenerative diseases inside and outside of the brain, with the goal to deliver disease-modifying treatments to patients suffering from these devastating neurodegenerative diseases. Throughout the second quarter and in recent months, we have continued to make significant progress toward achieving that goal. Most notably, we initiated our 201 trial, the Phase 2a clinical trial using IkT-148009 for Parkinson's disease, with the opening of the first clinical site on May 23 of this year. As of August 12, we have opened 11 of up to 40 sites that are planned, and began screening patients. This represents a major milestone for us, as well as for patients and families living with Parkinson's disease. This clinical study will allow us to begin to evaluate the safety and tolerability of IkT-148009 in a three-month dosing regimen. The choice of the dosing duration was made to balance the unknown safety of long-term dosing of IkT-148009 against the outcomes of animal model studies, where, in animals, the therapeutic dosing resulted in substantive recovery from the effects of Parkinson's disease in just eight weeks in both the brain and gastrointestinal tract. Also, in recent weeks, we have filed our investigational new drug, or IND application for IkT-001Pro, our project formulation of imatinib mesylate, which we will apply to stable-phase chronic myelogenous leukemia. Although an administrative delay had occurred, we expect to hear from the FDA by August 26, 2022, on the status of the IND, and we are now working hard to initiate the bioequivalence study to identify the dose of 001Pro equivalent to 400 milligrams of imatinib mesylate, the standard of care for stable phase CML. Finally, we have continued to progress our early-stage pipeline for other Parkinson's related indications, like multiple system atrophy, commonly referred to as MSA. As we look ahead to the remainder of 2022, we anticipate achieving a number of key milestones. As I just mentioned, we expect to begin dosing healthy volunteers in our bioequivalence study of IkT-001Pro, following FDA review of the IND. In addition, we will present additional data from the 101 study, our Phase 1/1b study of - clinical trial study of IkT-148009 at the Movement Disorder Society Congress in Madrid, Spain, in September of this year. Now, let turn to an in-depth review of our clinical and pre-clinical portfolio, beginning with our lead program, IkT-148009, a highly selective non-receptor Abelson Tyrosine Kinase, or c-Abl inhibitor, for the treatment of Parkinson's disease and related disorders. As you know, Parkinson's disease remains one of the most prevalent neurodegenerative disorders and affects nearly 1 million people in the US annually. Currently, all marketed therapeutic approaches for Parkinson's only help manage the symptoms of the disease, and there are no available options that slow or halt disease progression. We designed 148009 with the hope to address the substantial unmet need. IkT-148009 is a brain penetrant compound, which works by blocking the activation of the Abl kinase, which may in turn halt and reverse the loss of dopamine-secreting neurons in the brain NGI tract. IkT-148009 has so far demonstrated a low toxicity profile in healthy subjects, and in Parkinson patients, at least up to seven days of daily dosing. However, this does not mean that long-term safety of the drug is known. All of these features of IkT-148009, including the ability of Abl kinase inhibition to protect against the development and progression of Parkinson's-like disease in the brain, have been confirmed in validated animal models, giving us substantiate - giving us a basis for pursuing Abl kinase inhibition as potential disease-modifying therapy in patients. We made substantial progress with IkT-148009 in recent months. In June, we were pleased to announce that we advanced into a Phase 2a study dubbed the 201 trial, following a review of the study protocol and the Phase 1/1b data or 101 trial data by the US Food And Drug Administration. As you know, the 101 trial was a single and multiple setting dose safety, tolerability, and pharmacokinetics trial designed to evaluate once-daily administration of IkT-148009. The study evaluated single doses, up to 325 milligrams per day, and multiple doses up to 100 milligrams, first in 80 older and elderly healthy adults, and subsequently in 13 patients with mild to moderately advanced Parkinson's disease. As we announced in June of this year, and as we will share in greater detail at the Movement Disorder Society Congress in September, we're pleased to observe that clinical pharmacology of 1409 in patients, both with parallel to clinical pharmacology of 1409 in older healthy volunteers. And also, that 1409 demonstrated a favorable safety and tolerability profile up to a dose of 325 milligrams, with no clinically significant adverse events observed. We shared these results with the FDA, who reviewed safety, tolerability, and PK data from the first two cohorts of the 101 trial, as well as the proposed trial protocol for 201, and the FDA agreed that we can proceed with the 201 trial. The 201 trial was initiated at the end of May 2022, just 16 months after IkT-148009 entered the clinic. This study will allow us to further evaluate the long-term safety and potential benefit of IkT-148009 in patients with Parkinson disease. The 201 trial is a three-to-one randomized, double blind 12-week dosing trial that will evaluate the safety, tolerability, and steady state PK of IkT-148009 as primary endpoints. The trial will enroll approximately 120 patients with untreated Parkinson's disease who have not yet progressed to the need for symptomatic treatment. Patients will be treated at one of three randomized doses, at 50,100 or 200 milligrams given once daily. The trial will also evaluate a hierarchy of Parkinson's-related disease assessments in the brain and gut as secondary or exploratory endpoints. Turning now to our pre-clinical efforts. Let me begin with IkT-001Pro, our pro-drug formulation of imatinib mesylate, which we have designed as a potentially safer alternative to the first FDA-approved Ableson kinase inhibitor known as imatinib. IkT-001Pro is the first program to emerge from our novel pro-drug platform, which aims to improve the safety and tolerability of approved and novel therapeutics. As you know, imatinib is commonly taken for hematological and gastrointestinal cancers that arise from Abl kinase mutations found in the bone marrow, or for gastrointestinal cancers that occur from c-KIT mutations in the stomach. IkT-001Pro has the potential to be a safer alternative for patients, and may improve the number of patients that reach and sustain complete cytogenic responses in stable phase chronic myelogenous leukemia or CML in preclinical studies. IkT-001Pro has shown to be as much as three times safer than imatinib in non-human primates, reducing burdensome gastrointestinal side effects that occur following oral administration. Imatinib delivered as IkT-001Pro was granted an orphan drug designation for stable phase CML in September of 2018. Our bioequivalence clinical trial is designed to evaluate the safety profile of IkT-001Pro, as well as identify dose with similar systemic exposure and PK to 400 milligrams of imatinib at 96 hours post-dose administration. Once the equivalent dose is determined, we plan to initiate a superiority study, comparing the selected dose of IkT-001Pro to generic Gleevec in existing stable phase CML patients. Finally, we are continuing to advance IkT-1409 as a potential treatment of multiple system atrophy. MSA is a rare, rapidly progressive neurodegenerative movement disorder that affects both the central and autonomic nervous systems. Similar to Parkinson's disease, MSA is characterized by pathological alpha-synuclein aggregation, which may lead to cell dysfunction and degeneration of neurons. MSA affects approximately 20,000 people in the US, and there are currently no approved treatments to slow or halt progression of this disease. We have taken a multi-pronged approach to determining whether IkT-148009 could be a beneficial treatment for MSA. Like our work in Parkinson's, we have gated our clinical efforts with having a successful outcome in animal model studies of human MSA that are ongoing. Simultaneously, we continue to prepare and file regulatory documents with US FDA, and equivalent authorities in the EU 27 countries. However, current economic times necessitate that we preserve capital, and therefore, initiation of the MSA trial itself will also require us to raise additional working capital to execute the planned Phase 2 trial in MSA. Now, let me turn over the call over to Joe Frattaroli to review our financials. Joe?

Thank you, Milton. Let me review our financials for the three and six months ended June 30, 2022. For the second quarter 2022, we reported at net loss of approximately $4.6 million, or $0.18 per share, compared to a net loss of approximately $2.6 million, or $0.22 per share for the second quarter of 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 a share in the six months ended June 30, 2021. Research and development expenses were approximately $3 million for the second quarter of 2022, compared to approximately $2.4 million for the second quarter of 2021. Research and development expenses were $6 million for the six months ended June 30, 2022, compared to $4.8 million in the six months ended June 30, 2021. Selling, general and administrative expenses were approximately $1.7 million for the second quarter 2022, compared to approximately $1.6 million for the same period in 2021. Selling, general and administrative expenses for the six months of June 30, 2022, were $3.3 million, compared to $3.2 million for the six-month period, June 30, 2021. As of June 30, 2022, Inhibikase had approximately $32.2 million in cash and cash equivalents, and we expect that our existing cash and cash equivalents will be sufficient to fund our normal operations and capital expenditure requirements through December 31, 2023. That concludes our financial statements, and I would like to hand the call back over to Milton for closing remarks.

Thank you, Joe. As I mentioned earlier, we are very encouraged by our progress year-to-date, and look forward to continued momentum across our clinical and pre-clinical programs in 2022, as we work to improve the lives of patients suffering from neurodegenerative diseases. We are laser focused on clinical execution as we begin to screen patients for our 201 study, and prepare to initiate our bioequivalent study of the IkT-001Pro in healthy volunteers. We also look forward to updating you again soon, beginning with the presentation of results of our Phase 1/1b trial of IkT-148009 at the Movement Disorder Society Congress, in Madrid, Spain, in mid-September. Thank you all for your continued support as we seek to provide value and approve patient outcomes. I would now like to open the call to questions.

[Operator instructions]. The first question comes from Soumit Roy with Jones Research. Please go ahead.

Hi, this is Danya for Soumit Roy. Congrats on the progress. I have a few questions. To start with, is there any color that you can add on the September data for the Phase 1 study? Any - remind us from the dose levels, how many patients were treated? Thanks.

As we previously indicated, we treated - we had planned to do three cohorts of eight patients each at three doses, 50, 100, and 200 milligrams. When we reached six of eight patients in the 100-milligram dose, we had heard back from the US FDA agreeing with our plan to proceed with the Phase 2 dosing period. So, we elected to terminate the trial early and advance into the Phase 2 because the 200-milligram dose that was to be explored in the Phase 1b, is also being explored in the Phase 2 trial, and we saved approximately $600,000 in doing so. We previously stated that our observations on the Parkinson's-related parameters were not expected to teach us anything about the disease or anything about the potential clinical effectiveness for 148009. The only thing we wanted to know was whether the pharmacokinetics of the drug in Parkinson patients was the same as, or similar to what it was in healthy volunteers, and that we have repeatedly made public. We have - we will review at the MBS Congress in mid-September, the measurement of Parkinson’s-related parameters, where we'll demonstrate that there's no worsening of the disease in the presence of drug administered once daily for just seven days. Beyond that, there was nothing more to be learned or expected to be learned in that trial because of the short dosing duration and small subject size. So, we don't draw any conclusions, unless they need to be drawn.

Okay, thank you. And as for the Phase 2 that you just initiated, can you guide us to - about when you will expect patients to start getting the different doses, the progress on that?

Well, these are early - these are patients that are not currently on medication, so they have a little bit less urgency in their involvement in clinical trial work compared to patients that are already on levodopa therapy. And so, what we found is that as we're bringing up sites and we have 11 sites open now, patients are scheduling their screening visits for August and September. And so, while we were disappointed that that's what they're doing, we also don't have any control over it, sadly. We were - that's just sort of how it is. Patients who are - this summer has been an unusually heavy travel season for everyone. People have taken long vacations and have traveled to Europe and beyond, and that appears to have affected sort of the rapid rollup. We anticipate having an upcoming press release more about that study in the near future, but I can't say more about it than that.

Got it. So, you don't have any guidance for that or I guess when we should expect any next data update.

Well, the trial is fully blinded across three dosing cohorts and placebo. So, there will not be interim readouts along the path unless some miracle happens and the data review committee says it becomes unethical not to proceed into a properly powered study. We don't, we - our view is that three-month dosing may begin to show clinical benefits based on the animal model studies we've previously reported about repeatedly, but we don't know that. It may not be quite a long enough dosing duration and that we don't consider it to be a negative. But at our current state of knowledge, it won't surprise us if we begin to see clinical benefit in three months. The most important thing of course is, is that we have to demonstrate long-term safety of an oral kinase inhibitor in around 100 patients, because that's what the - that's the metric the FDA uses to allow you to go into chronic dosing. We'll be also sharing our chronic dosing toxicology data with the FDA in the near future. That's part of our 10-Q filing. And so, that combination, as we could begin to see what the patient experience is on multi-month dosing, will allow us to then proceed. We don't expect to report results out until the later part of 2023, as we previously said.

Okay, thank you very much, and congrats again.

This concludes our question-and-answer session. I would like to turn the conference back over to Dr. Milton Werner, CEO, for any closing remarks.

I just want to thank everyone for sticking with the company through these very difficult times. Obviously, the entire market has been severely suppressed, our stock included, and it has been a painful period for everyone. The positive thing about Inhibikase in our view is that we have had very few negative or missing milestone events. We have not seen any reason that to discourage either of our primary assets to proceed in the clinic. We've made very rapid progress on understanding the pharmacology of these drugs in human beings, and we are encouraged by upcoming events that we anticipate in the near future that could further illuminate the potential clinical benefits of both IkT-148009 in multiple areas, and 001Pro in stable phase CML. And we thank all of our shareholders and the public for their continued support.