Good day, and welcome to Inhibikase Therapeutics' second quarter 2022 financial results conference call. All participants will be in a listen-only mode. Should you need assistance, please find our conference specialist by pressing the star key followed by zero. After today's presentation, there will be an opportunity to ask questions. To ask a question, you may press star then one on your touchtone phone. 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, Senior 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 the Inhibikase quarterly report on Form 10-Q for the second quarter 2022, which is being 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 like 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 wanna 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 substantial 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 prodrug 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 bioequivalent study to identify the dose of IKT-001Pro equivalent to 400 mg 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 bioequivalent study of IKT-001Pro following FDA review of the IND.
In addition, we will present additional data from the 101 study, our phase I, IB study of clinical trial study of IKT-148009 at the Movement Disorder Society Congress in Madrid, Spain in September of this year. Now let me 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 c-Abl 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 U.S. 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 and GI tract. IKT-148009 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 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 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 II A study dubbed the 201 trial. Following a review of the study protocol and the phase I/I B data or 101 trial data by the U.S. 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-148009. 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 Disorder Society Congress in September, we were pleased to observe that clinical pharmacology of IKT-148009 in patients closely paralleled the clinical pharmacology of IKT-148009 in older healthy volunteers. Also that IKT-148009 demonstrated a favorable safety and tolerability profile up to a dose of 325 milligrams, with no clinically significant adverse events observed. We share 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 could 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's disease. The 201 trial is a 3-1 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 mg, 100 mg, or 200 mg, 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 IkT-001Pro, our pro-drug formulation of imatinib mesylate, which we have designed as a potentially safer alternative to the first FDA-approved Abl kinase inhibitor, known as imatinib. IkT-001Pro 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 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 cytogenetic 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 a dose with similar systemic exposure and PK to 400 mg 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-148009 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 U.S., 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 the U.S. FDA and equivalent authorities in the E.U. 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 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 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 $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 of 2022 compared to approximately $1.6 million for the same period in 2021. Selling, general, and administrative expenses for the six months ended 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 has 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 a 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 101 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 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 keys. If at any time your question has been addressed and you would like to withdraw your question, please press star then two. At this time, we will pause momentarily to assemble our rolodex. The first question comes from Sumit Roy with Jones Research. Please go ahead.
Hi, this is Dania for Sumit 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 I study? Remind us from the dose levels, and how many patients were treated? Thanks.
As we previously indicated, we had planned to do three cohorts of eight patients each at three doses, 50 mg, 100 mg, and 200 mg. When we reached six of eight patients in the 100 mg dose, we had heard back from the U.S. FDA, agreeing with our plan to proceed with the phase II dosing period. We elected to terminate the trial early and advance into the phase II because the 200-milligram dose that was to be explored in the phase I B is also being explored in the phase II trial, and we 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 IKT-148009.
The only thing we wanted to know was whether the pharmacokinetics of the drug in Parkinson's 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'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. We don't draw any conclusions unless any to be drawn.
Great. Thank you. As for the phase II that you just initiated, can you guide us on about when you will expect patients to start getting the different doses? Any progress on that?
Well, 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. 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. While we were disappointed that that's what they're doing, we also don't have any control over it, sadly. 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. 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 3 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. Our view is that three months 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 at three months. The most important thing, of course, is that we have to demonstrate long-term safety of an oral c-Abl 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. Until 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, as we previously said.
Okay. Thank you very much. Congrats again.
Thank you.
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's 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-148009 in multiple areas and IKT-001Pro in stable phase CML. We thank all of our shareholders and the public for their continued support.
This conference has now concluded. Thank you for attending today's presentation. You may now disconnect.