Q2 2022 Inhibikase Therapeutics Inc Earnings Call
Spain in September of this year. Now let me turn to an in-depth review of our clinical and preclinical portfolio beginning with our lead program IKT1409, 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 1489 with the hope to address the substantial unmet need. IKT1409 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 and GI tract. IKT1409 has so far demonstrated a low toxicity profile in healthy subjects and in Parkinson's 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 IKT1409 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 a basis for pursuing Abl kinase inhibition as potential disease modifying therapy in patients. We made substantial progress with IKT1409 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-ascending dose safety, tolerability, and pharmacokinetics trial designed to evaluate once-daily administration of IKT-14-809. The study evaluated single doses up to 325 milligrams per day and multiple doses up to 100 milligrams, first in 88 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 Disorders Society Congress in September , we were pleased to observe that clinical pharmacology of 1409 in patients closely paralleled the 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 mg 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 TRIO-1 trial was initiated at the end of May 2022, just 16 months after IKT1409 came to the clinic.
This study will allow us to further evaluate the long-term safety and potential benefit of IKT14809 in patients with Parkinson's 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 IKT1409 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 preclinical efforts, let me begin with IKT01-Pro, our pro-drug formulation of imatinib mesylate, which we have designed as a potentially safer alternative to the first FDA-approved Abelson kinase inhibitor known as imatinib.
IKT401Pro is the first program to emerge from our novel project 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 able kinase mutations found in the bone marrow or for gastrointestinal cancers that occur from c-kip mutations in the stomach.
IKT-O and PRO 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 myelitis, leukemia or CML.
Preclinical studies by KTO and PRO has shown to be as much as
three times safer than a matinee of a non-human primate, reducing burdensome gastrointestinal side effects that occur following oral administration.
Imatinib delivered as IKT-01 Pro was granted an orphan drug designation for stable face remain thus far away from taking their lead in their careers.
Our Bioequivalence Clinical Trial is designed to evaluate the safety profile of IKT01Pro as well as identify a dose with similar systemic exposure and PK to 400 milligrams of matinib at 96 hours post-dose administration.
Once the equivalent dose is determined, we plan to initiate a superiority study comparing the selected dose of IKT01-Pro to generic Leveq in existing stable phase single patients.
Finally, we are continuing to advance IKT1409 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 IKT1409 could be a beneficial treatment for MSA. Like our work in Parkinson's, we have been working with the
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 the 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 II trial in MSA.
Now let me turn the call over to Joe Fradarola to review our financials.
Thank you, Milton.
Let me review our financials for the three and six months ended June 30, 2022. For the second quarter of 2022, we reported a 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 37 cents per share, compared to a net loss of $5.3 million, or 47 cents a share, in the six months ended June 30, 2021.
Thank you.
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 of 2022. It's approximately $1.6 million for the same period in 2021.
selling general and administrative expenses for the six months ended June 30, 2022, or $3.3 million compared to $3.2 million for the six month period June 30, 2021.
As of June 30, 2022, inhibit case set 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 here to date, and look forward to continued momentum across our clinical and preclinical 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 a bioequivalent study of the IKT 01 Pro and healthy volunteers.
We also look forward to updating you again soon, beginning with the presentation results of our Phase 1-1b trial of IKT 1409 at the Movement Disorders Society Congress in Madrid, Spain in mid-September.
Thank you all for your continued support as we seek to provide value and improve patient outcomes.
I would now like to open the call to questions.
Thank you. We will now begin the question and answer session.
To ask a question, you may press star then one on your touchtone phone. If you're using a speakerphone, please pick up your handset before pressing the key.
If at any time your question has been addressed and you would like to withdraw your question, please press the start and chew. At this time, we will pause momentarily to assemble our ROKTOR.
The first question comes from Sunit Roy with Jones Research. Please go ahead. For more 911was minimized...
Hi, this is Dania for Show Me Troy. Congrats on the progress. I have a few questions. To start with, is there any color that you can add in the September data for the phase 1 study?
Any other questions?
remind us from the dose levels and how many patients were muted.
And how many patients were needed? Nothing
As we previously indicated, 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 two dosing period. So we elected to.
terminate the trial early and advance into the phase two because the 200 milligram dose that was to be explored in the phase 1B is also being explored in the phase two trial and will be saved approximately $600,000 in doing so.
We previously stated that our observations
on the Parkinson related parameters were not expected to teach us anything about the disease or anything about the potential clinical effectiveness of 14.8.09. 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 will review at the MDS Congress in mid-September the measurement of Parkinson-related parameters, where we'll demonstrate that there's no worsening of the disease in the presence of drugs 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 of our attorney to be drawn.
Thank you.
As for the phase two that you just initiated, can you guide us into about...
when you will expect patients to start getting the different doses.
You progress on that?
You know, 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, you know, that's just sort of how it is. Patients who are, you know, 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 roll-up. 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 co-work and placebo, so there will not be interim leadouts 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 long a long enough dosing duration and that we don't consider to be a negative, but...
at our current state of knowledge, it won't surprise us if we begin to see clinical benefit in the three months.
The most important thing, of course, 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 10q filing and and so that combination as we can 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. That's what we previously said.
Thank you very much.
This concludes our question and answer session. I would like to turn the conference back over to Dr. Newton Warner, 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 inhibit case in our view is that we have had very few negative or missing milestone events.
We have not seen any reason 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-4209 in multiple areas and O1-Pro in stable face CML. And we thank all of our shareholders and the public for their continued support.
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