Aptinyx Inc.

Good afternoon and welcome to the APNIC second quarter 2022 financial results conference call. At this time, all participants are in a listen-only mode. 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 Mr. Patrick Flavin, Senior Manager of Corporate Development and Investor Relations at APNIC. Patrick, please go ahead.

Thanks, Kelly, and good afternoon, everyone. Thank you for joining us on today's conference call to discuss AptoNix's second quarter 2022 financial and operating results. We invite you to visit the investor section of the AptoNix website to view our press release describing financial results and business highlights from the second 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, and Harold Merck, Vice President of Clinical and Medical Affairs, are 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. I'm happy to say that despite our disappointing data redact for NYX2925 and DPN in April, we've otherwise made great progress over the past few months and are well positioned to deliver several major milestones from our pipeline of NMDA receptor modulators. First of these is the data set from our Phase 2b study of NYX2925 in patients with fibromyalgia, which we expect to receive and communicate later this month. We're also pleased to announce that we've recently been able to close new patient screening in our Phase II study of NYX458 in cognitive impairments associated with Parkinson's disease, and we therefore expect to complete enrollment in the next few weeks. As a result, we're on track to record data from this study in the first quarter of 2023. In addition, we continue to make progress with our Phase IIb study of NYX783 in patients with PTSD, and we remain on track for a data readout in the second half of 2023. As a reminder, this study is assessing the 50 milligram QD dose level of NYX783, with the study of the 150 milligram QD dose level having been paused last quarter following the DPN readout. I'm also very excited to share that NYX783 will soon begin a phase one study for the treatment of opioid use disorder, or OUD. This study is enabled by a multi-million dollar grant awarded to researchers at Yale University School of Medicine, who's demonstrated the potential of NYX783 in preclinical studies and will be conducting the phase one study. The grant is sponsored by the NIH and administered by the National Institute on Drug Abuse, or NIDA. This funding for the development program enables us to partner with world-class researchers and expand the therapeutic potential of NYX783 in a new indication all through non-dilutive financing that preserves our cash runway. With strong progress across our pipeline, we're fortunate that our current balance sheet can enable data re-diets from all of our ongoing studies. Let's discuss our pipeline programs in more detail, beginning with NYX2925 and fibromyalgia. As I mentioned, we plan to receive and communicate data from our Phase 2b study of NYX2925 in patients with fibromyalgia later in August. As a reminder, This follows the promising effects seen in our prior phase 2A neuroimaging study in fibromyalgia that we red-eyes in 2019. These prior data, as well as several differences in the underlying biology between fibromyalgia and DPN, provide a basis for optimism as we approach the data redact. Since fibromyalgia is a multifaceted centralized pain disorder, we've designed the study to incorporate some exploratory features. We're testing multiple dose levels of NYX 2925, 50 milligrams QD, and 100 milligrams QD, and are evaluating patients across a variety of symptom endpoints related to pain severity, fatigue levels, sleep quality, and impact on daily function. That said, we've also based the design of the study on what we believe will be the requirements for a pivotal trial so that it can be as informative as possible. This is a 12-week randomized placebo-controlled double-blind study, and we're testing NYX2925 as a monotherapy with no concomitant analgesics. The primary endpoint is the change from baseline to week 12 in patient-reported average daily pain, averaged over a week, and evaluated using the 0 to 10 numeric rating scale, or NRS. Study is powered to detect and affect size that's clinically meaningful. Depending on what the exact degree of variation seen in pain score differences, the lower bound of what's needed to achieve statistical significance would be approximately a 0.5 difference between NYX2925 and placebo on the NRS. Next steps following the completion of this study would include an end-of-Phase II meeting with FDA to discuss requirements for Phase III and NDA. We expect that positive data in this study would unlock significant value for FDA. We believe that a well-tolerated therapy with a novel mechanism of action, such as NYXC925, represents a multibillion-dollar commercial opportunity in the U.S. alone, with 50 to 70 percent of diagnosed patients discontinuing existing approved therapies after just one year due to tolerability issues and the lack of sustained efficacy. As we've previously mentioned, this opportunity is driven by substantial patient volume and unmet need rather than by price. Given the enormity of the treatment landscape, we've long believed that a larger commercial partner would add meaningful value in maximizing the reach of an approved therapy. This is an avenue we will certainly consider for our program under the right circumstances. I'd like to thank all APSINIC's colleagues and partners for their hard work and dedication bringing this study to completion. We look forward to receiving the results and communicating them very soon. Let's move on to NYX458 in phase two development for the treatment of cognitive impairment in Parkinson's disease and dementia with Lewy bodies. I'm very pleased with the progress made over the past several months in this study. We've remained focused on execution and have recently been able to stop screening new patients with sufficient patients already in the screening pipeline at our sites to meet our enrollment goal. We therefore expect to complete enrollment in the next few weeks as these last patients complete screening And we're on track to report data from this study in the first quarter of 2023. You may recall that the study's population has expanded from mild cognitive impairment associated with Parkinson's disease to also encompass mild dementia in Parkinson's disease as well as dementia with Lewy bodies. As enrollment nears completion, it's now clear that the majority of patients in the study will have a diagnosis of mild cognitive impairment or dementia associated with Parkinson's disease. and there will be relatively fewer patients with dementia with Lewy bodies. These differences reflect screening activity and therefore the availability of suitable subjects within these diagnostic groups at our study sites. We're very comfortable that the patient population we've enrolled will enable a robust reading. Although this is an exploratory phase two study, we've applied a well-controlled design with the potential to generate strong proof of concept data. The study is randomized, placebo-controlled, and double-blinded, which will enable us to characterize the therapeutic benefits of NYX458 accurately. We expect final enrollment of approximately 100 patients across two groups, placebo and 30 mg QD of NYX458, with a treatment period of 12 weeks. In addition to evaluating the safety and tolerability of NYX458 in patients, the study employed well-validated tablet-based neurocognitive assessments to evaluate effects across key cognitive domains, including attention, memory, and executive function. While this current study focuses on Parkinson's disease, we believe the positive data would unlock the opportunity to further develop NYX458 across other cognitive impairment conditions. We look forward to sharing more updates in the coming months as the study moves toward completion ahead of the expected readout in Q1 2023. Finally, let's move on to NYX783. NYX783 is currently being evaluated in a Phase IIb study in patients with post-traumatic stress disorder. The study, which kicked off towards the end of last year, is evaluating 50 milligrams of NYX783 QD versus placebo in approximately 300 PTSD patients over 10 weeks of treatment. As a reminder, our similar study looking at 150 milligrams QD was placed on a temporary pause prior to the start of its enrollment in order to extend our cash runway following our DPN data readout in April. We remain committed to recommencing this study when it's operationally and financially feasible to do so. Following the initiation of the Phase 2b study for the 50 milligram dose in December, our team has worked diligently to bring the study sites online and begin enrolling patients. Despite an increase in clinical development activity in PTSD across the industry, which has increased competition for sites and patients, we've seen steady progress over the past few months, and we remain on track to report data from the study in the second half of 2023. In addition, as I mentioned at the beginning of the call, we're very excited that the FDA recently cleared our IND application to allow for the evaluation of NYX783 in patients with opioid use disorder, or OUD. This IND is a testament to the productive partnership APSINICS has enjoyed with a world-class team of researchers at Yale University School of Medicine, which spearheaded an impressive preclinical development effort building on our work in extinction learning in PTSD and alcohol use disorder. This Yale team has generated compelling preclinical data supporting the hypothesis that the extinction learning mechanism underlying NYX783 may provide a safe and effective treatment for OUD. In their studies, NYX783 showed positive effects combined with a strong safety profile in models of addiction utilizing oxycodone. The preclinical data set was generated with the support of a multi-million dollar grant under the NIH's Helping to End Addiction Long-Term, or HEAL, initiative. Based on the preclinical evidence, our research collaborators at Yale recently received preliminary approval by the NIH and NIDA to transition to clinical stage development, starting with a phase one study of NYX783 in people who use opioids to begin later this year. Opioid use disorder represents a significant public health issue facing society today, and this phase one study in OUD will be a critical first step to evaluating NYX783's potential for treatment. We look forward to sharing more details and updates on this program later in the year, as the clinical stage grant funding is formally announced and the phase one study is initiated. I'll now hand over to Rasheesh to review our quarterly financials.