Aptinyx Inc.

Good afternoon and welcome to the APTENIX third quarter 2022 financial results conference call. At this time, all participants are on listening mode only. Following the formal remarks, we will open up the call for your questions. Please be advised this call is being recorded at the company's request. At this time, I would like to turn the call over to Patrick Flavin, senior manager of corporate development and investor relations at APTENIX. Patrick, please proceed.

Good afternoon, everyone, and thank you for joining us on today's conference call to discuss Apptonix's third quarter 2022 financial and operating results. We invite you to visit the investor section of the Apptonix website to view our press release describing financial results and business highlights from the third quarter of 2022. On today's call, Andy Kidd, our President and Chief Executive Officer, will discuss our business and clinical development progress. Then Ashish Khanna, our Chief Financial Officer and Chief Business Officer, will review our financial results. In addition, Catherine King, Senior Vice President of Clinical and CMC Operations, is on the line for the Q&A portion of the call. I would like to remind everyone that statements made during this conference call will include forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, which involve risks and uncertainties that can cause actual results to differ materially. Any forward-looking statements are made only as of today, and we disclaim any obligation to update these forward-looking statements. Please see the forward-looking statement disclaimer in our financial results release issued this afternoon and the risk factors in the company's current and subsequent filings with the SEC. It's now my pleasure to turn the call over to Andy.

Thanks, Pat. Good afternoon, everyone, and thank you for joining us on today's call. The past few months have seen several major updates to our pipeline of clinical stage programs. In August, we announced that NYX2925 did not meet its primary endpoint in our Phase 2b study in fibromyalgia. and that we do not intend to focus our current resources on further development of NYX2925 in chronic pain. This outcome was obviously disappointing and underscores the significant challenges that exist in chronic pain drug development. Despite our disappointment in that result, we continue to have confidence in the potential of the remaining programs on which we focused our energy and resources, NYX458 in cognitive impairment and NYX783 in PTSD and opioid use disorder. We've always viewed our platform and pipeline as providing diversification of clinical risks. While our drugs are all derived from a common chemistry platform focused on NMDA receptor modulation, NMDA receptors play different roles in our different clinical indications. Therefore, our clinical stage pipeline provides multiple shots on goal with largely independent clinical risks, and we're looking forward to all of our remaining data readouts expected in 2023. I'm happy with the progress we've made over the last few months in positioning ourselves for these readouts. In August, we completed enrollment in our phase two study of NYX458 in cognitive impairment and expect to report data from the study in the first quarter of 2023. This exploratory study is designed to evaluate the role of NYX458 in improving cognitive function in patients with mild cognitive impairment or dementia associated with Parkinson's disease or dementia with Lewy bodies. Given the huge need for novel therapies in these disease areas, a positive signal should enable us to move into a larger study that we hope could serve as a pivotal trial and would position NYX458 as one of the few late-stage development programs for Parkinson's cognitive impairment. In addition, we've made steady progress on enrollment in our Phase 2b study of NYX783 in patients with PTSD and remain on track for a data readout in the second half of 2023. NYX 783 is also being developed for the treatment of opioid use disorder through research funded by a recently finalized $5.6 million grant from the NIH awarded to researchers at Yale University School of Medicine. Together with Yale, we expect to commence a phase one study of NYX 783 by the end of this year and complete it in the second half of next year. Importantly, we expect our existing cash resources of over $65 million provide operational runway into 2024 and support the data readouts from each of our clinical development programs. Let's discuss the Phase 2 study of NYX458 in cognitive impairment in more detail. The study completed enrollment in August with a total of 99 patients. The majority of these patients have a diagnosis of mild cognitive impairment or mild dementia associated with Parkinson's disease, with fewer patients diagnosed with dementia with Lewy bodies. The study is randomized, placebo-controlled, and double-blinded, and we'll evaluate 30 milligrams QD of NYX458 versus placebo over a treatment period of 12 weeks. Since this is the first time we're evaluating NYX458 in patients, the primary endpoint is safety and tolerability, and the efficacy endpoints are exploratory. We're taking a thorough approach to characterizing the efficacy profile of NYX458 by incorporating a range of cognitive assessments at secondary and exploratory endpoints. Each of these endpoints is designed to measure specific aspects of cognitive function. The first set of endpoints is based on six computerized neurocognitive tests provided by Cogstate, a leader in brain health assessments. These include the following tests, continuous paired associate learning, Groton-Mays, the identification test, international shopping list, and one-back and two-back tests. This battery of tests was chosen because they focus on specific aspects of cognition that are impaired in Parkinson's disease. We will assess changes from baseline and versus placebo in each individual test, as well as a cognitive composite score and four sub scores reflecting the different cognitive domains assessed by the tests. The cognitive composite score will combine the results of all six tests and provide a key measure of the overall cognitive effects of NYX458. The subscores are each based on different subsets of data from the six neurocognitive tests. There is a subscore for each of the following cognitive domains, attention, working memory, learning and memory, and executive function. In addition to endpoints based on the neurocognitive tests, we're also measuring endpoints related to everyday function. The ECOG-12 is a simple instrument that measures the patient's assessment of their performance on 12 functional abilities related to cognitive performance. The PDAC-15 is another instrument that assesses the extent to which cognitive impairment from Parkinson's disease impacts 15 activities of daily living. We're also measuring clinicians, patients, and caregivers' assessments of the severity and change in overall Parkinson's symptoms using the CGIS and CIVIC Plus scales. Together, all of this data will enable us to determine whether NYX458 shows a signal of improved cognitive performance and will also give us a sense as to what extent this improved cognitive performance impacts patient function. Our goal is to assess the nature and magnitude of the effects of NYX458 in order to guide the design of larger late stage studies. We hope to see a signal on overall cognitive performance and associated signs of functional improvement that could then be confirmed in future studies. Our immediate plans, if the data are positive, would include meeting with FDA to discuss the requirements for an NDA in this area and the design of our next clinical trial. Mild cognitive impairment and dementia associated with Parkinson's disease represent a significant area of unmet medical need and, accordingly, commercial potential. We believe this study will offer key insights into NYX458 therapeutic potential in this area and that the value creation from positive data should be substantial. We've worked hard to bring this study close to the finish line, and we look forward to reporting these results in Q1 of next year. Let's move on to NYX783. NYX783 is currently being evaluated in a Phase IIb study in patients with post-traumatic stress disorder, or PTSD. This study is evaluating 50 milligrams of NYX783 QD versus placebo in approximately 300 PTSD patients over 10 weeks of treatment and utilizing the change in CAHPS 5 total score as the primary endpoint. Key secondary endpoints include clinicians and patients' global impressions of disease severity and improvement. During Q3, we've completed activation of the full complement of study sites, all of which are located in the U.S., and we've seen our enrollment progress at a steady pace. As such, the study remains on track to report data in the second half of 2023. NYX783 is also in early clinical development as a novel therapy for the treatment of opioid use disorder, or OUD. Last week, we announced the finalization of a $5.6 million NIH grant awarded to our research collaborators at Yale University School of Medicine. The grant was issued under the NIH's Helping to End Addiction Long-Term, or HEAL, initiative and will fund an upcoming phase one study, as well as a subsequent larger proof of concept study to be initiated once the phase one study is successfully completed. Phase one drug-drug interaction study, which is being conducted by the researchers at Yale, is set to begin by the end of this year and is expected to complete in the second half of 2023. This study is an important safety and regulatory requirement, enabling later stages of development in OUD. It's an inpatient study that will assess the safety, tolerability, and pharmacokinetics of NYX783 in combination with oxycodone in individuals who use opioids. The primary outcomes of the study will evaluate a variety of safety-related measures. Secondary outcome measures will evaluate opiate withdrawal and symptom scales. Preclinical data from NYX783 and models of OUD, which served as the foundation for the grant and the phase one study, will be presented at the Society for Neuroscience or SFN annual meeting in San Diego next week. We're excited for this phase one study to commence and are pleased to be expanding the clinical evaluation of the therapeutic potential of NYX783 in a capital efficient manner. I'll now hand it over to Ashish to review our quarterly financials.