Good day, and welcome to the Inhibikase Therapeutics third quarter 2022 financial results conference call. All participants will be in a listen-only mode. Should you need assistance, please signal a 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 a touch-tone 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, Stern Investor Relations. Please go ahead.
Good morning, and welcome to Inhibikase Therapeutics third 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. Yesterday, Inhibikase issued a press release announcing financial results for the third quarter ended September 30th, 2022. We encourage everyone to read yesterday's press release as well as Inhibikase's quarterly report on Form 10-Q, 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, November 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 for joining us today to review Inhibikase's third quarter 2022 financial results and recent business updates. Let me start by providing an update on our IkT-148009 or 1489 programs. On November 7, we announced that the U.S. Food and Drug Administration had reviewed our investigational new drug or IND application for IkT-148009 for the treatment of multiple system atrophy or MSA. As a result of their review, they issued a clinical hold on the IkT-148009 201 program in Parkinson's disease or PD, and the use of IkT-148009 in MSA. In their email correspondence, the FDA indicated that an official clinical hold letter will be issued within 30 days.
I would like to highlight to date that we have observed only two mild adverse events in the ongoing phase II-A, 201 trial and have recorded no serious adverse events. We are actively working with the FDA to understand the agency's concerns and to resolve them as soon as possible. In the interim, we plan to conduct a blinded safety assessment based on the first 11 patients that were enrolled in the 201 trial and were randomized one-to-one for the 12-week once daily dosing. However, since none of the initial 11 patients had fully completed the study, once the clinical hold is lifted and subject to discussions with the FDA, the study will need to be restarted.
In addition, I would like to reiterate results from our Phase 1 and 1b study of IKT-148009 that were presented at the Movement Disorder Society Congress in September of this year. These data highlighted that IKT-148009 was safe and well-tolerated over 7 days of daily dosing, with high systemic exposure and persistent penetration into the central nervous system or CNS. That was true in both healthy volunteers and in patients with Parkinson's disease. Moreover, assessments of motor, non-motor, and quality of life in patients enrolled in this study showed that treatment with IKT-148009 did not worsen disease over 7-day dosing. Our highest priority is to resolve any questions and concerns from the FDA to resume our clinical development of IKT-148009 as soon as possible.
Turning briefly to our preclinical efforts, we are continuing to advance IkT-001Pro towards the clinic by the end of the year. As a reminder, IkT-001Pro is our prodrug formulation of imatinib mesylate, developed to improve the safety of the first FDA-approved Abl tyrosine kinase inhibitor, known as imatinib, as a treatment for chronic phase chronic myelogenous leukemia or CML. We received FDA clearance for our IND application for IkT-001Pro in August of this year. 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. Our prodrug formulation has the potential to be a safer alternative for patients and may improve the number of patients that reach and sustain major or complete cytogenetic responses in chronic phase CML.
In preclinical studies, IkT-001Pro could be dosed up to 3.4 times higher than imatinib in non-human primates before inducing an adverse event. If observed in people, this has the potential to reduce the burdensome gastrointestinal side effects that occur following oral administration in CML or gastrointestinal stromal tumor patients. We are now advancing IkT-001Pro into a single ascending dose 501 bioequivalence study to evaluate the safety and efficacy of the drug. The study will enroll approximately 56 male and female healthy volunteers between the ages of 25 and 55 who will receive IkT-001Pro at one of three doses. The study will also aim to identify a dose with a similar systemic exposure and pharmacokinetic profile compared to 400 milligrams of imatinib mesylate, the standard of care drug at 96 hours post-administration.
We expect the dosing of the first patient to occur during the fourth quarter of 2022. Before we open the call to questions, I want to provide a brief update on our financials. As of September 30, 2022, we had approximately $26.5 million in cash equivalents, and marketable securities. Net loss for the quarter was approximately $4.5 million or $0.18 per share. We expect our existing cash equivalents, and marketable securities will be sufficient to fund our normal operations and capital expenditure requirements through February 2024, subject to outcomes from our discussions with the FDA on the IkT-148009 program. As we look to the remainder of the year, we will continue to provide updates as appropriate on the clinical hold of our IkT-148009 programs.
Additionally, we expect to initiate our 501 bioequivalence study for IkT-001Pro by the end of the year. I want to thank our shareholders for their continued long-term support of Inhibikase as we remain fully committed to our mission to improve the lives of patients suffering from devastating neurodegenerative and oncological diseases. I would like to now open the call for questions. Operator.
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 are 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. Once again, that is star then one to ask a question. This concludes our question and answer session and concludes the conference call. Thank you for attending today's presentation. You may now disconnect.