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spk03: to the In Hippocase fourth quarter and full year 2022 earnings conference call. All participants will be in 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 your touch-tone phone. To withdraw your question, please press star then two. Please note, today's event is being recorded. I would now like to turn the conference over to Alex Lobo with Stern IR. Please go ahead.
spk00: Good morning, and welcome to Inhibit Case Therapeutics' fourth quarter and full year 22 financial results conference call and audio webcast. With me today is Dr. Milton Werner, Chief Executive Officer, and Joseph Frateroli, Chief Financial Officer. On Friday, March 31, 2023, Inhibit Case issued a press release announcing financial results for the full year ended December 31, 2022. We encourage everyone to read Friday's press release, as well as Inhibit Case's annual report on Form 10-K, 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 3rd, 2023. 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.
spk02: Thank you, Alex, and thank you all for joining us today to review our full year 2022 financial results and recent clinical and business updates. 2022 was an important year for us as we continued to advance our mission to bring disease-modifying therapeutics to patients living with neurodegenerative diseases and cancer. We were excited to continue to advance our lead asset, IKT Fortune 8009, in the clinic, as well as further validate the underlying mechanism through presentations at several notable scientific and industry conferences. While the FDA clinical hold on our 14809 programs last year was an unexpected challenge, we were pleased to announce that the agency had lifted our hold on the Parkinson's program in January. With that hold lifted, we are working diligently to restart the Phase 2A201 clinical trial with the agreed-upon amendments. In March, the FDA lifted the clinical hold on IKT-14-09 for the treatment of multiple system atrophy, or MSA, and opened the IND, enabling the planning of a future Phase II trial in MSA. Simultaneously, our 501 bioequivalent study for IKT-01-pro, which is a pro-drug formulation of imatinib mesylate intended to treat stable-phase chronic myelogenous leukemia, has completed three of four dose escalation cohorts, and it is anticipated that that dose finding and dose equivalence program will be completed by the close of the second quarter of this year. As we work to make 2023 another year of clinical execution, we recently completed a concurrent registered direct offering and private placement, which bolstered our cash reserves by approximately $10 million in aggregate gross proceeds. With the addition of these funds, we are well capitalized into the fourth quarter of 2024 to advance our clinical programs through key milestones. Now let me first start with an update to our IKT 1409 programs. IKT-14809 is our selective non-receptor Abelson tyrosine kinase, or C-ABL inhibitor. As we published in January of this year, IKT-14809 has been shown to halt disease progression, protect and restore lost neurons in the brain and GI tract, and clear the underlying protein pathology, as was shown in animal studies. Today, Parkinson's disease is one of the most devastating neurodegenerative diseases in the U.S., with roughly 60,000 new diagnoses in the U.S. each year, and there are currently no available options at slow or a halt in progression of this disease. Let me expand further on the potential of IKT14909 as a disease-modifying therapy Parkinson's and related disorders. Our animal model studies, which were published in the journal Science and Rational Medicine on January 18th of this year, highlights data from one study oral administration of IKT14909 in animal models that mimic the rate of disease progression relative to lifespan observed in human Parkinson's disease. These studies showed that IKT-1409 was able to halt disease progression, drive functional recovery, and protect neurons from degradation. These features correlated with substantial reduction in the underlying protein aggregate pathology. We believe these data form the basis for our belief in the potential of IKT-1409 as a disease-modifying therapy for patients and continues to support clinical development of IKT-1409 in Parkinson's disease. Turning now to our 201 program, Despite the unexpected setback last year, we were pleased to announce that the FDA lifted the full clinical hold on IKT1409 in Parkinson's in January. The FDA based the decision on our complete response to the issues raised in the hold letter, which we submitted in December to the Division of Neurology. In our response, we agreed to measure the pharmacokinetics of the 200 milligram top dose planned in the study in six healthy volunteers before implementing the dose in the 201 trial itself. This pharmacokinetic profile has now been completed and we anticipate submitting the data to the FDA within the coming days. The FDA further requested the measurement of visual acuity and examination of the corneum lens to complement the analysis of the retina, macula, and fundus that was already part of the ocular monitoring program set up in the trial. This monitoring program is consistent with the ocular pathology monitoring programs of other marketed protein kinase inhibitors. We also want to emphasize that to date, no ocular pathology has been observed in any trial participant administered IKT at 1409. and no clinically meaningful adverse events have been observed in any healthy subject or Parkinson's patients to date at any dose or dose duration up to 11 weeks of IKT 1409 given once daily. With 20 of approximately 35 planned sites already open and several having completed the steps to start screening patients, we are pleased that the first patient screenings began last week. We will update the status of the 2-1 trial enrollment later in the second quarter. We're also excited to be moving forward with our IKT 1409 program in multiple system atrophy, or MSA. following the recent lift of the clinical hold by the FDA. MSA is a rare, rapidly progressive neurodegenerative movement disorder that affects both the central and autonomic nervous systems. In 2021, we published in the journal Neurobiology of Disease that C-able activation and alpha-synuclein phosphorylation at tyrosine 39 also occurs in MSA in a manner that is similar to what has previously been described in Parkinson's. Our ongoing animal model studies that we discussed during a recent R&D day continue to encourage our planning efforts for a future Phase II trial. Turning now to an update of our 501 bioequivalent study of IKT-001-PRO, as you might recall, 001-PRO is our pro-drug formulation of imatinib mesylate intended to enhance the safety and tolerability of imatinib in patients with stable chronic myelogenous leukemia, or CML. Imatinib is commonly taken for hematological and gastrointestinal cancers, which arise from able kinase mutations located in the bone marrow or GI tract. we are evaluating whether IKT-01 Pro has the potential to be a safer and better-tolerant alternative for patients on chronic and magnetic therapy to control their disease. The 501 study is a two-part bioequivalence trial, with the first part comprised of four escalating doses across 27 healthy subjects between the ages of 25 and 55, and our intent is to identify the bioequivalent dose. Three of the four dosing cohorts have already been completed in that study. The second phase of the study will confirm the measured bioequivalence dose in 32 additional healthy volunteers using a two-period crossover study. This study will also evaluate the adverse event profile and patient-reported outcomes as metrics of superiority over standard of care. We are contemplating the evaluation of high-dose imatinib, such as 600 milligrams, and to identify the equivalent dose of O1-pro to further amplify the differences in potential safety and tolerability of high-dose imatinib delivered as pro-drug. I would like to now turn the call over to Joe Frateroli, our Chief Financial Officer, to review the financials. Joe?
spk01: Thank you, Milton. Let me review our financials for the year ended December 31, 2022. Grant revenue was $0.1 million for the year ended December 31, 2022, compared to $3.1 million for fiscal year 2021. The decrease was due to the company's primary focus during 2022, being shifted toward advancing our Phase 1 and 2 human clinical trials, which were not grant-related activities. Our research and development expenses were $12 million for the year end of December 31, 2022, compared to $11.4 million for the year end of 2021. The increase was primarily due to ongoing non-grant-related research and development activities, mostly related to the Phase 2A-201 clinical trials. Selling general and administrative expenses were $6.2 million for the year ended December 31, 2022 compared to $6.5 million for the prior fiscal year. The decrease was primarily the result of decreased warrant expense of $0.7 million and a decrease of stock-based compensation of $0.5 million, partially offset by increased legal fees of $0.4 million, increased regulatory and compliance fees of $0.2 million, and a net increase of 0.3 million for other normal operating expenses. For the year ended December 31, 2022, we reported a net loss of approximately 18.1 million or 72 cents per share compared to a net loss of 14.8 million or 81 cents per share in the year ended December 31, 2021. As of December 31, 2022, we had approximately 23.1 million in cash, cash equivalents, and marketable securities. This excludes the approximately 10 million of aggregate gross proceeds from our January 2023 and current registered direct offering and private placement before deducting placement agent fees and other offering expenses payable by any other case. We expect that existing cash, cash equivalents, and marketable securities will be sufficient to fund operations into the fourth quarter of 2024. That concludes our financial statements. I'd like to hand the call back over for any closing remarks.
spk02: Thank you, Gerald. We remain passionate about the work we do at Inhumicase, and we are confident that we have the resources necessary to advance both our neurodegenerative and oncology programs towards key milestones in the clinic. As we look towards 2023 and beyond, we anticipate sharing additional clinical updates for 1409 as the 201 trial begins to enroll patients. to continue advancing our remaining preclinical efforts in MSA and complete the 501 bioequivalent study for IKT01 Pro. We view 2023 as the year of growth and execution as we continue to ideate groundbreaking therapeutics and to help patients and families living with these devastating diseases. We would like to thank our shareholders and partners for their continued support. And now I'd like to open the call to questions. Operator?
spk03: Thank you. We will now begin the question and answer session. To ask a question, you may press star then 1 on your touch-tone phone. If you are using a speaker phone, we ask that you 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 2. At this time, we will pause momentarily to assemble our roster. And ladies and gentlemen, as a reminder, if you'd like to ask a question, please press star then 1 at this time.
spk02: I'm sorry, operator. Did you just say there was a question or there was nothing?
spk03: No, sir. I was just reprompting for questions, and it appears there are no questions at this time. So that does conclude today's question and answer session and today's conference call. We'd like to thank you all for attending today's presentation. You may now disconnect your lines and have a wonderful day.
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