Aptinyx Inc.

Good afternoon and welcome to the Aptinex first quarter 2021 financial results conference call. At this time, all participants are in a listen-only mode. Following the formal remark, we will open the call for questions. Please be advised that the call is being recorded at the company's request. At this time, I would like to turn the call over to Nick Smith,

vice president corporate development and investor relations at aptinix nick please proceed thank you operator good afternoon everyone and thank you for joining us on today's conference call to discuss aptinix's first quarter 2021 financial and operating results our press release describing financial results and recent highlights is available on our website Today on our call, Norbert Riedel, our Chief Executive Officer, will review our business and clinical progress, followed by Ashish Khanna, our Chief Financial Officer and Chief Business Officer, who will review the financial results. In addition, Andy Kidd, our President and Chief Operating Officer, and Catherine King, our Senior Vice President of Clinical Development, and Harold Merck, our Vice President of Medical and Pharmacovigilance, are with us for the Q&A portion of the call. Before we begin, I'd 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 statements disclaimer in our financial results release issued this afternoon and the risk factors in the company's current and subsequent filings with the SEC. Norbert, over to you.

Thank you, Nick, and good afternoon, everyone. We appreciate you taking the time to join us on today's call. Before we delve into our clinical programs, I would like to share with you that we have recently announced the appointment of Dr. Joan Miller to our Board of Directors. John brings extensive experience in academic and medical leadership, clinical development, and clinical research to our board, and we are excited to have her join us as we progress into later stage clinical development. Related to our clinical programs, although it has only been a few weeks since our last business update call, we have made important progress across each of our four programs. As you recall, we currently have three Phase II clinical studies underway, one in painful DPN, one in fibromyalgia, and one in cognitive impairment. Our teams have been executing diligently on patient enrollment in these studies, and I'm happy to report that each of these studies is tracking very well. We also have been keenly focused on moving our PTSD program toward initiation of a phase 2b study with the design intended to be registration supportive in this indication. These past few weeks in particular have come with a number of positive developments for our PTSD program. So I will start with those updates for NYX783. In late April, we presented additional data from our initial exploratory PTSD study at the annual meeting of the Society of Biological Psychiatry, or SOBP. These data provide insights from stage one of the study, which was a four-week treatment period that included all patients in a double-blind, randomized, parallel design, most consistent with and informative of our next study. we reported that a significantly greater proportion of patients achieved a clinically reliable change in the 50 milligram treatment group compared to placebo. The reliable change index is defined as an improvement of 13 points or more on the CAHPS 5 total score and is a recognized metric for determining real effects as opposed to effects driven purely by variability. Our SOBP presentation also highlighted that when accounting for baseline imbalances across groups in the patient's time since trauma, the percentage improvement on the CAHPS 5 total score for the NYX78350 milligram group separated from placebo by a statistically significant margin. These additional analyses reinforce our confidence in the therapeutic potential of NYX783 in the treatment of PTSD. Also in late April, we met with the FDA for a Type C meeting to discuss the future development path in PTSD and to review the key design parameters of our planned Phase IIb study. It was a positive meeting during which the agency provided us with valuable input on a variety of study parameters, and we are in the process of finalizing the details of the protocol for the upcoming study accordingly. As we have laid out at a high level in our public presentations to date, this study will involve an evaluation of 8 to 12 weeks of daily dosing of NYX783 compared to placebo in a randomized parallel design with the CAHPS 5 total score as the primary endpoint. We will be proceeding with that design and, accordingly, if the data are positive, we believe the study has the potential for consideration by the agency as one of the two well-controlled studies required in support of an NDA. Of course, that will be a matter for review by the agency follow the completion of the study and review of the data. We plan to provide greater details on the study design and continue to anticipate that we will commence this Phase IIb study in the second half of this year. Let's briefly discuss NYX2925, which is in Phase II clinical development across two chronic pain indications. In painful diabetic peripheral neuropathy, and in fibromyalgia. I am glad to report that we have made excellent progress in both studies, and we continue to be on track towards our enrollment goals and our projected data readouts in the first half of 2022. We appreciate the continued engagement from the investigator sites and patients involved in these studies. Let's move now to NYX458, our product candidate in development for the treatment of cognitive impairment. We recently announced that we have recommenced an exploratory phase two study in patients with cognitive impairment associated with Parkinson's disease and with dementia with Lewy bodies. This is the first time NYX458 is being evaluated in patients with these diseases. This exploratory study is designed to detect the signal of therapeutically relevant activity of NYX458 and to assess its tolerability profile in this patient population. This is a double-blind, randomized, parallel design study and is expected to enroll approximately 100 patients to receive daily dosing of either 30 milligrams of NYX458 or placebo over a 12-week treatment period. Given the novel mechanism of NYX458, we are evaluating multiple cognitive endpoints in this study in order to characterize the activity across attention, memory, and executive function. I am pleased with our progress so far, and we expect to be able to report data from this study in the second half of 2022. With that, I will now turn the call over to Achish to review our first quarter financial results.