Aptinyx Inc.

Good afternoon and welcome to the after next first quarter 2022 financial results conference call. At this time, all participants are listen only mode, following the formal remarks, we will open up the call for your questions, please be advised, the call is being recorded at the company's request. At this time i'd like to turn the call over to pat flavin senior manager of corporate development and investor relations after next pat please proceed.

Good afternoon, everyone, and thank you for joining us on today's conference call to discuss AppSynics' first quarter 2022 financial and operating results. We invite you to visit the investor section of the AppSynics website to view our press release describing financial results and business highlights from the first 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. 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 FCC. It's now my pleasure to turn the call over to Andy.

Thanks, Pat. Good afternoon, everyone, and thank you all for taking the time to join us on today's call. The past few months have brought some challenges, but also great progress for Aptinex. I'd like to start by acknowledging the disappointing results of our phase 2B study of NYX2925 in painful diabetic peripheral neuropathy that we announced in early April. We also announced shortly after those results that we were temporarily pausing the initiation of our second phase 2B study of NYX783 in PTSD, evaluating the 150 milligram dose. This was done in order to extend our cash runway and to enable us to focus resources on our other Phase 2b study of NYX783 in PTSD, evaluating the 50 milligram dose. This step, along with some additional prioritization of resources, allows our end of Q1 cash balance of $100 million to enable data readouts from each of our three ongoing Phase 2 programs over the next 18 months. I'm very happy to say that this broader pipeline remains fully on track. And over the last few months, we've made meaningful progress across all of our other programs with NYX2925 in fibromyalgia, with the 50 milligram dose of NYX783 in PTSD, and with NYX458 in cognitive impairment. We're therefore poised to reach several major milestones in the months ahead. Thanks to our team's continued excellent execution, we currently expect data re-diets from NYX2925 in fibromyalgia in July or August of this year. from NYX458 in cognitive impairment in late Q4 of this year, or Q1 2023, and from NYX783 in PTSD in the second half of 2023. Let's discuss our clinical programs in more detail, beginning with NYX2925. We began 2022 with NYX2925 under evaluation in two chronic pain indications, painful diabetic peripheral neuropathy, or DPN, and fibromyalgia. As I mentioned, in April, we announced the results from our Phase 2b DPN study. Unfortunately, the study did not meet its primary endpoint of separation from placebo on the 0 to 10 NRS pain rating scale at 12 weeks compared to baseline. Overall, the data did not show a clear clinical benefit of daily dosing of 50 milligrams of NYX295 relative to placebo and do not justify a path forward in this DPN indication. This result was obviously very disappointing and certainly not what we had hoped for. We based the Phase IIb DPN study on data and analyses from our previous Phase IIa study in DPN. We, of course, always knew that pain in DPN is initiated by an underlying progressive peripheral pathology, but we had a biological hypothesis supported by data from our previous study that supraspinal brain-based pain processing abnormalities become a significant characteristic over time in DPN. This led us to evaluate the centrally acting mechanism of NYX2925 in a specific subset of longer disease duration DPN patients in the Phase IIb study, each of whom had experienced neuropathy symptoms for four or more years. Since the data from this study suggests that even longstanding pain originating from peripheral neuropathy is not an appropriate disease for our mechanism to target, we made the decision to discontinue our development in painful DPN going forward. NYX2925 is also currently being evaluated in a Phase IIb study in patients with fibromyalgia. In contrast to painful DPN, fibromyalgia is not classified as a peripheral neuropathy and is instead widely thought to be a centralized pain state in which supraspinal pain processing abnormalities arising in the brain are a primary characteristic. Based on prior preclinical and clinical data, we've shown that NYX2925 operates by modulating NMDA receptors in key brain regions responsible for the cognitive control of pain and pain perception, which presents a compelling biological rationale for evaluating NYX2925 as a treatment for fibromyalgia. Fortunately, we will not have to wait long for the data from this Phase 2b study in order to determine if these differences in underlying biology and mechanistic rationale compared to DPN can yield a different positive result. The Phase IIb study in fibromyalgia completed enrollment in February of this year and is on track to report results in just a few months' time in July or August. The study is assessing NYX2925 as a monotherapy without other concomitant analgesics over a 12-week treatment period. We feel these design choices are in line with regulatory requirements for future pivotal studies. We're testing daily dosing of 50 milligrams of NYX2925, 100 milligrams of NYX2925 or placebo over the 12 weeks of treatment. The primary endpoint in the study 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. Alongside changes in average daily pain, additional endpoints will also measure the impact of fibromyalgia symptoms on daily function, as well as changes in other symptoms such as fatigue and sleep. The study is powered to detect an effect size that is clinically meaningful. Depending on the degree of variation seen with pain scores, that powering would be consistent with somewhere between a 0.5 and 0.7 difference or greater between NYX2925 and placebo on the 0 to 10 NRS scale. Next steps following this study would include an end of phase two meeting with FDA to discuss requirements for phase three and NDA. We remain optimistic about this program, not only because of the strong biological rationale and precedent clinical data supporting its development, but also for the opportunity to deliver a novel therapeutic solution to the over 8 million underserved patients living with fibromyalgia in the U.S. alone. Let's move now to our next clinical program, evaluating NYX783 in patients with PTSD. In December of last year, we initiated a Phase 2b study evaluating 50 milligrams of NYX783 versus placebo. The study will enroll approximately 300 patients and evaluate them over 10 weeks using the CAHPS5 total score as the primary endpoint. The 50 milligram dose level of NYX783 was selected based on the signal seen with that dose on the CAHPS5 scale over just four weeks of treatment in our previous Phase 2a study. Certain design parameters were incorporated in our follow-up Phase IIb study to help mitigate potential placebo responses, and the overall design was finalized following a Type C meeting with the FDA to discuss the requirements for a pivotal study in this indication. Based on early enrollment trends in the study, we expect to be able to report data in the second half of 2023. We had also planned to initiate a second Phase IIb study to evaluate a higher 150 milligram dose of NYX783 in patients with PTSD with a design very similar to that of the 50 milligram study. As I mentioned previously, we announced last month that we will temporarily pause the initiation of this 150 milligram Phase IIb study. Decision was driven by two main factors. First is the ability to preserve capital and enable our existing cash balance to deliver rediets from each of our other in-process clinical trials. The second is the ability to focus our efforts in PTSD on the 50 milligram study. We had experienced a few challenges in initiating clinical trial sites on schedule in our PTSD studies due to a number of other studies in this indication being conducted in the US across the industry. While we believe we've addressed these challenges, focusing our efforts should additionally de-risk our ability to enroll a 50 milligram study within our planned timelines. At the time of the pause, the 150 milligram study had not yet begun screening or enrolling patients. A number of the sites that were planned to contribute to the study will now shift their focus to the 50 milligram study. We remain enthusiastic about studying the higher 150 milligram dose in this indication, and we'll make the decision to recommence the study as soon as we believe it makes financial and operational sense to do so. In addition to our progress in the clinic, we've also published additional preclinical data demonstrating the positive effects of NYX783 in models relevant to PTSD in the April edition of the journal Molecular Psychiatry. This data further characterizes the therapeutic potential of NMDA receptor modulation to treat the learned fear and stress commonly associated with PTSD. These preclinical data were also recently presented during a symposium discussion at the Society of Biological Psychiatry's annual meeting in New Orleans earlier in May, and they will also be presented at the upcoming American Psychiatric Association meeting later in the month. Let's move on to NYX458, our product candidate and development for the treatment of cognitive impairment associated with Parkinson's disease and dementia with Lewy bodies. Enrollment in our exploratory phase two study in this indication has progressed at a steady rate since the start of the year. We continue to expect to report data either towards the end of this year or in the first quarter of 2023. This is the first inpatient study designed to assess safety and to detect the signal of the activity of NYX458 on measures of cognitive performance. While the study is exploratory and primarily signal finding, we believe it is robustly designed to detect a therapeutically meaningful signal. The study is a double-blind, randomized, parallel design study planning to enroll approximately 100 patients that will receive daily dosing of either 30 milligrams of NYX458 or placebo over a 12-week treatment period. Given the novel mechanism of NYX458, were evaluating multiple cognitive endpoints in the study in order to characterize the activity across the critical cognitive domains of attention, memory, and executive function. Not only are these domains characteristic of cognitive impairment in Parkinson's disease and dementia with Lewy bodies, but they are known to be NMDA-dependent phenomena. This program represents an exciting opportunity to address a major unmet need in cognitive impairment, and we hope the data from this study will be a significant step towards achieving that goal. With that, I will now turn the call over to Ashish to review our first quarter financial results.