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| Statement |
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| The -- because you saw indications, and these are just mild indications that as you increase the dose, you saw increasing benefit across many anti-Parkinsonian assessments was encouraging to us |
| Collectively, we believe that these accomplishments continue to demonstrate the potential of our programs to deliver transformative treatments for patients |
| We are very pleased with the progress we've made throughout the third quarter as we have advanced our clinical and preclinical pipeline programs |
| In the orphan disease areas, we are pleased to receive orphan drug designation from the U.S |
| We believe that our programs have the potential to provide safe and efficacious treatment options for patients with Parkinson's and Parkinson's related disorders |
| IkT-001Pro demonstrated a favorable safety intolerability profile with minimal adverse events across 66 subjects in the trial |
| The preliminary data from the 11 patients that we pulled from the trial in 2022 is encouraging, but it's too small a data set to draw a strong conclusion |
| This designation will allow us to advance our work in MSA at greater speed and is encouraging to see the FDA acknowledge of devastating nature of MSA and the high unmet need that exists in the market |
| And MSA offers the opportunity to amplify those outcomes because patients with MSA decline at 4 times faster rate than patients with Parkinson's disease who have a bigger dynamic range or a bigger measurement range over which you're going to see potential benefits |
| As scientists, we are always excited by the prospect of leveraging learnings from our work into new developments |
| In October, we were pleased to receive orphan drug designation from the U.S |
| The tablet nearly doubles drug exposure at steady state for the same dose of risvodetinib, which allow -- which may allow for lower doses that could lead to an overall improvement in safety and tolerability of risvodetinib |
| But there is an additional application of imatinib, where the indications of improved safety from 001Pro may be very attractive, and that's in pulmonary arterial hypertension |
| We believe that such molecules, whether acting alone or in combination with active c-Abl inhibitors like risvodetinib could be an improved approach to suppressed neurodegeneration arising from c-Abl activation inside and outside of the brain |
| We have imaging and biomarker analyses that are validated in the MSA in a way that they are not yet validated in Parkinson's and the faster rate of progression means a faster readout of potential benefit |
| This novel tablet formulation is designed to improve drug exposure and overcome existing challenges related to patient use and mimics the oral formulation we used to evaluate efficacy and validated animal models of Parkinson's disease |
| Our medicinal chemistry efforts are also progressing, and we are excited to announce the evaluation of second-generation c-Abl inhibitors that emerge from internal programs and external collaborations |
| In August, we announced the emergence of several new second-generation molecules from internal medicinal chemistry programs and external collaborations that we believe could enhance suppression of neurodegeneration through c-Abl inhibition |
| We have been working closely with our 28 active clinical sites to accelerate screening and enrollment into the trial and are pleased to say that we currently have 24 participants enrolled, seven prospective participants are undergoing screening evaluations and 15 potential participants undergoing informed consents |
| Before we open the call to questions, I would like to thank all our shareholders and partners for their continued support and dedication to Inhibikase |
| And MSA is really important |
| Great |
| And so it's an interesting potential application that can be further explored |
| As the value of c-Abl inhibition in neurodegeneration continues to come in to focus on the scientific community, we believe that the potential of risvodetinib too will continue to be recognized as a potentially disease-modifying treatment for Parkinson's |
| We work diligently to demonstrate the importance of our research with the scientific and investor communities, and we look forward to providing our shareholders and partners with updates as we progress in studies across our pipeline in order to transform the treatment paradigm for neurodegenetive diseases |
| And so we think the trial is very feasible |
| Can you make any comments on potential partner interest? Milton Werner Well, there are two areas where that drug could be very attractive, certainly, to the CML and also to the gastrointestinal stromal or GIST community, although we're seeking initially just a label for CML in imatinib intolerance and newly diagnosed |
| Edward White Good morning |
| Thanks |
| Thank you |
| Statement |
|---|
| While the data set has to few participants to conclude a clinical benefit, we view these results with cautious optimism as we continue to roll patients in the ongoing 201 trial |
| You mentioned that R&D spending we saw was down from -- excuse me, up from last year, but down 29% quarter-over-quarter |
| As you may recall, a number of years ago, Phase III program from Novartis was rejected by the FDA and it was not pursued further by Novartis because of safety concerns at the doses used for imatinib in PAH, which is the acronym for pulmonary arterial hypertension, but 001Pro offers a move away from those risk factors |
| 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 |
| Now let me review our financial results for three months ended September 30, 2023 for the third quarter 2023, we report a net loss of approximately $4.6 million or $0.86 per share compared to a net loss of $4.49 million or $1.06 per share for the quarter ended September 30, 2023 |
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