Q4 2019 Aptinyx Inc Earnings Call
EVANSTON Mar 31, 2020 (Thomson StreetEvents) — Edited Transcript of Aptinyx Inc earnings conference call or presentation Monday, March 30, 2020 at 9:00:00pm GMT
TEXT version of Transcript
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Corporate Participants
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* Andrew Kidd
Aptinyx Inc. – COO
* Ashish Khanna
Aptinyx Inc. – CFO & Chief Business Officer
* Kathryn King
Aptinyx Inc. – SVP – Clinical Development
* Nicholas C. Smith
Aptinyx Inc. – Director of Corporate Development
* Norbert G. Riedel
Aptinyx Inc. – President, CEO & Director
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Conference Call Participants
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* Charles Cliff Duncan
Cantor Fitzgerald & Co., Research Division – Senior Analyst
* Gary Jay Nachman
BMO Capital Markets Equity Research – Analyst
* Laura Kathryn Chico
Wedbush Securities Inc., Research Division – SVP of Equity Research
* Lyla Youssef
Cowen and Company, LLC, Research Division – Research Associate
* Marc Harold Goodman
SVB Leerink LLC, Research Division – MD of Neuroscience & Senior Research Analyst
* Yuko Oku
JP Morgan Chase & Co, Research Division – Analyst
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Presentation
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Operator [1]
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Good afternoon, and welcome to Aptinyx Fourth Quarter and Year-End 2019 Financial Results Conference Call. (Operator Instructions)
Please be advised that today’s call is recorded at the company’s request.
At this time, I’d like to turn the call over to Nick Smith, Senior Director of Corporate Development and Investor Relations at Aptinyx. Nick, please proceed.
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Nicholas C. Smith, Aptinyx Inc. – Director of Corporate Development [2]
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Thank you, Valerie. Good afternoon, everyone, and thank you for joining us on today’s conference call to discuss Aptinyx’s Fourth Quarter and Year-End 2019 Financial and Operating Results.
Our financial results and company updates press release is now available on our website.
Today on our call, Norbert Riedel, our President and Chief Executive Officer, will review our business and clinical progress. And then Ashish Khanna, our Chief Financial Officer and Chief Business Officer, will review the financial results. In addition, Andy Kidd, our Chief Operating Officer; and Kathryn King, our Senior Vice President of Clinical Development, 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.
It’s now my pleasure to turn the call over to Norbert.
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Norbert G. Riedel, Aptinyx Inc. – President, CEO & Director [3]
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Thank you, Nick, and good afternoon, everyone. We appreciate you joining us on our call today, especially during these extraordinary and challenging times. Recent events related to the ongoing COVID-19 pandemic have created a significant degree of uncertainty around the world and within our industry. Against that backdrop, we think it is very important for us to communicate to our shareholders, the progress we have made across our pipeline program. And also to provide you with an update on the impact COVID-19 is having on our business, specifically.
Before getting into those impacts, I’d like to review the significant progress we made in 2019. The year was marked by numerous clinical milestones and relentless execution by our team in support of our mission of developing novel therapies for patients suffering from challenging CNS disorders. At the outset of last year, we set ambitious clinical development goals that centered around advancing all 3 of our clinical stage product candidates into new Phase II studies. Thanks to the terrific efforts of our team, we accomplished those goals and initiated 4 Phase II studies last year. These studies will evaluate and characterize the ability of our novel compound to address significant unmet needs in the areas of chronic pain, PTSD and cognitive impairment.
I am very proud of everything the team has accomplished throughout the year to achieve that development program. It is also important to note that we have continued our momentum into 2020 and have been making good progress across each of our studies. Of course, we, like many throughout our industry, are experiencing some challenges introduced by the COVID-19 pandemic. And in light of these challenges, we have made certain decisions regarding our clinical development activity.
Let’s start with an update on NYX-783 as our study of that compound in PTSD is furthest along. In 2019, we began evaluating NYX-783 in an initial exploratory Phase II study in patients with PTSD. The study, in approximately 150 patients, is intended to evaluate for the first time, the effect of the unique and novel mechanism of NYX-783 on a broad array of symptoms experienced by people with PTSD. To date, we have achieved approximately 80% of our target enrollment, and by all metrics enrollment in the study has been progressing and tracking well. While there have been some disruptions at the site level brought on by the COVID-19 pandemic, so far we have been able to manage and mitigate them. We are working with our investigator sites to develop appropriate accommodations to support patient continuity, such as home delivery of study drug and virtual participant follow-up. Where these are required and feasible.
Given some of the specific needs of patients with PTSD, we feel it is in the interest of patients’ welfare to continue enrollment in this study at this time, and we appreciate the perseverance and dedication of our investigators and sites to keep moving the study forward. We continue to enroll new patients into this study and will make every effort to do so as long as it remains responsible and feasible. We will remain vigilant in our continuous evaluation of the impact of COVID-19 to this study, including primary focus on patient safety and well-being and close dialogue with our sites and CROs.
Given the ongoing uncertainty around COVID-19, we anticipate providing updated guidance on the expected timing of completion and readout of data from this study at a future date.
Now let’s discuss NYX-2925, which is in Phase II clinical development in 2 chronic pain indications, painful diabetic peripheral neuropathy and fibromyalgia. In 2019, we read out our first Phase II studies in patients with these conditions. Our first study in fibromyalgia evaluated the effect of NYX-2925 and on validated neuroimaging biomarkers of central pain processing. We saw that 2925 resulted in statistically significant changes in these biomarkers and that these biomarker effects were culminated with clinically meaningful and statistically significant improvements in pain and other fibromyalgia symptoms. Alongside, we run our first study of NYX-2925 in patients with painful DPN. The compelling signals of pain reduction we saw in that study helped inform dose selection, patient inclusion and exclusion criteria and other design parameters for our current studies in chronic pain, which are aimed at validating these signals. Together, these initial studies have provided tremendously important information on NYX-2925. It gets into the brain and enhances NMDA receptor-mediated pathways. Its activity addresses abnormalities in central pain processing that can be observed objectively through imaging, and that activity translates into compelling signals of symptom improvement in patients who have experienced pain chronically.
Based on these first Phase II studies, in late 2019, we initiated 2 follow-up Phase IIb studies, 1 in painful DPN and in 1 in fibromyalgia, leveraging what was learned in the initial studies and intended to validate the effects we observed in those studies. Both studies are designed to evaluate the safety and efficacy of NYX-2925 over a 12-week period. We completed all of the start-up work and sites have been actively screening and enrolling patients in these studies. However, in light of challenges to screening and enrollment caused by the COVID-19 pandemic, on March 27, we temporarily suspended the enrollment of new patients into both of these studies. Importantly, patients that have already enrolled may continue in these studies, further protocols and in accordance with the guidelines set forth by the FDA and CDC in conducting clinical studies. We will continue to monitor this situation very closely and maintain active dialogue with our sites and CROs to determine when it is appropriate to resume enrollment in these studies. And we anticipate updating our guidance around the expected timing of the top line readouts from these studies at a future date following recommencement of enrollment.
Finally, let’s discuss our development of NYX-458 for the treatment of cognitive impairment associated with Parkinson’s disease. As we recently published in the journal movement disorders, we saw remarkable results with NYX-458 in a highly validated and translatable model in nonhuman primates, showing striking and durable reversal of cognitive deficits. Based on those data, we were very excited and enthusiastic to initiate our first study of NYX-458 in patients with Parkinson’s mild cognitive impairment last December. This exploratory Phase II study will evaluate the safety and potential cognitive benefits of NYX-458 in Parkinson’s patients for the first time. However, due to the particular risk posed by COVID-19 to these more vulnerable patients, we have decided to suspend the enrollment of new patients in this study as well. Despite the suspension of new enrollment, those patients who are already enrolled in the study may continue, consistent with the protocol and based on medical guidance. When appropriate, we are eager to reinitiate our investigation of NYX-458 in patients with cognitive deficits, and we look forward to providing updates on our plans and time lines for this program at a future date.
As we consider the impact of the COVID-19 pandemic on our business, I want to emphasize that while multiple factors informed our decisions on how best to proceed with each study, the health and safety of patients of the personnel involved in conducting these studies and of our employees has remained at the forefront throughout our evaluation. With regards to Aptinyx’ employees and operations, we instituted travel restrictions and remote working protocols some weeks ago ahead of the stay at home order issued as of March 21 by our government, Illinois, which remains in effect for at least April 7.
Fortunately, before the escalation of the pandemic, we have taken steps to accelerate shipping to the U.S. of our investigational drug products to facilitate uninterrupted supply for our studies. We will continue to track any potential effects of an extended disruption, but we feel comfortable about where we are with regard to supply at the present time. We are also fortunate to have a very healthy balance sheet and strong cash position. In January, we completed a common stock offering, adding net proceeds of approximately $33 million to our already strong cash balance. The financing included the participation of multiple existing investors. And importantly, we were pleased to have the support of a number of new quality health care dedicated investors as well. Including that financing, we expect our current cash will provide us with financial runway into 2022. We hope that runway will enable multiple clinical data readouts and we anticipate that it can, under a number of different scenarios. But ultimately, of course, we expect to provide updated guidance with regards to the timing of our clinical data readouts, following the resumption of our studies.
I will now turn the call over to Ashish to review our fourth quarter and year-end financial results.
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Ashish Khanna, Aptinyx Inc. – CFO & Chief Business Officer [4]
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Thank you, Norbert. Beginning with the balance sheet. We ended the fourth quarter with $98.8 million in cash and cash equivalents compared to $150.6 million at the end of 2018. As Norbert noted, we expect our current cash, including the $33 million in net proceeds from the common stock offering in January 2020, should enable Aptinyx to fund operations through this year through next year and into 2022. With respect to our income statement, revenues were $0.9 million and $3.7 million for the fourth quarter and full year 2019, respectively, as compared to $1 million and $6.6 million for the same periods in 2018. Our revenues are related to our research collaboration with Allergan, which we expect to come to its contractual conclusion this year. Importantly, we are not reliant on these revenues to fund our operations.
The majority of our spend remains heavily concentrated in research and development. R&D expenses totaled $10.6 million and $44.3 million for the fourth quarter and full year 2019, respectively, as compared to $10.9 million and $48.8 million for the same period in 2018. The decrease in R&D expenses during 2019 was primarily driven by a reduction in product and clinical development spend related to NYX-2925. We reported G&A expenses of $4.5 million and $19 million for the fourth quarter and full year 2019, respectively, as compared to $4.8 million and $12.7 million for the same period in 2018. This increase in spend from 2018 to 2019 was primarily driven by costs related to employee compensation, including $4.1 million in noncash stock compensation expense as well as professional fees to support ongoing business operations.
Finally, we reported a net loss of $13.8 million for the fourth quarter 2019 compared to a net loss of $14.1 million for the same period in 2018. For the full year 2019, net loss was $57.4 million compared to a net loss of $53.3 million for 2018.
I’ll now turn the call back over to Norbert.
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Norbert G. Riedel, Aptinyx Inc. – President, CEO & Director [5]
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Thanks, Ashish. Before we begin taking questions, I would like to convey our sincerest sympathy to go deeply and personally affected by COVID-19. Further, I want to reiterate that we are doing everything we can to mitigate the pandemic’s effect on our business. Despite the temporary pauses to enrollment being implemented in 3 of our 4 ongoing Phase II studies, we continue to be very optimistic about the potential our product candidates have to meaningfully help patients with chronic pain, post-traumatic stress disorder and cognitive impairment. This is certainly a challenging time for all of us. But I have great confidence in the capabilities, resilience and commitment of our team and our ability to persist in our mission to bring these important potential new therapeutic options to patients.
Operator, we are now ready for questions.
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Questions and Answers
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Operator [1]
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(Operator Instructions)
Our first question comes from Marc Goodman of SVB Leerink.
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Marc Harold Goodman, SVB Leerink LLC, Research Division – MD of Neuroscience & Senior Research Analyst [2]
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A couple of questions. First, can you give us a sense of just the past couple of weeks in the new normal, how enrollment was going in the PTSD trial? Obviously, it sounds like you still need another 30-odd patients or whatever. So we’re just trying to figure out when you think your best guess is that, that study will be finishing up.
And then second of all, another company, Axsome, licensed in a Pfizer product for fibromyalgia, Reboxetine. I was curious what you know about the product and what you think about it as a potential competitor to your product?
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Norbert G. Riedel, Aptinyx Inc. – President, CEO & Director [3]
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Okay. Marc, as always, thanks for your question. I’m going to have Andy, our COO, as well as Kathryn address your question on how has it been going in the past couple of weeks with respect to PTSD, and have it kicked off by Andy.
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Andrew Kidd, Aptinyx Inc. – COO [4]
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Yes. Thanks, Marc. So obviously, we’re keeping a very close eye on the progress of the study at the site level. Not just enrollment, but obviously, as Norbert alluded to, patient visits and trying to make accommodations where we can. We’ve still seen, I think, reasonably good progress recently in PTSD. But it’s sort of a day-by-day, week-by-week situation as you can appreciate. So it’s just really hard to make predictions about how long the rest of enrollment is going to take at this point. But I can say that there has been progress in the last 2 weeks. And for what it’s worth, we have found that encouraging.
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Norbert G. Riedel, Aptinyx Inc. – President, CEO & Director [5]
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Kathryn, anything you want to add to that?
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Kathryn King, Aptinyx Inc. – SVP – Clinical Development [6]
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No. I think that covers it well.
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Norbert G. Riedel, Aptinyx Inc. – President, CEO & Director [7]
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Okay. Sorry, Marc. Did you have a follow-up to that?
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Marc Harold Goodman, SVB Leerink LLC, Research Division – MD of Neuroscience & Senior Research Analyst [8]
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No. No. That’s good. And then the other question.
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Norbert G. Riedel, Aptinyx Inc. – President, CEO & Director [9]
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Okay. Yes. The other question was on Axsome in-licensing and fMRI. I’m going to have Ashish if you would answer to that.
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Ashish Khanna, Aptinyx Inc. – CFO & Chief Business Officer [10]
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Marc, thanks for the question. Yes, as Reboxetine, as you know, is a serotonin norepinephrine reuptake inhibitor. It’s pretty much like deloxitine in that regard, which acts anti-depressant activity and also as a therapy for patients with fibromyalgia. I think that we look at the space of fibromyalgia as a space of major unmet need, and those patients need additional therapeutic options to address the significant symptoms and the life-deciding effects of that disorder. So we welcome progress and root for progress across all the various domains. It’s a very different mechanism action target than what we’re working on. May have complementary effects. And so we’re eager to see its progress forward and help patients.
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Operator [11]
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Our next question is from Charles Duncan of Cantor Fitzgerald.
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Charles Cliff Duncan, Cantor Fitzgerald & Co., Research Division – Senior Analyst [12]
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. I wanted to ask you a question on the PTSD program, and what you talked about on the prepared remarks. I think that you said it was about 80% or so enrolled. And I guess, I’m wondering, if you had to stop that enrollment now, what do you think about the powering assumptions or the ability to demonstrate an effect size, and its — that study’s ability to inform next steps?
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Norbert G. Riedel, Aptinyx Inc. – President, CEO & Director [13]
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Terrific. Thanks, Charles. So first of all, as we have mentioned in the past, the PTSD study is our first inpatient study, and the goal here really is to find a signal that guides us as to a next study thereafter. So it isn’t really a study powered for statistical significance. It’s a signal-finding exploratory study.
Having said that, I think our goal is to do as much as we can to get as close as possible to the enrollment numbers that we have communicated for the study to be approximately 150 patients when it’s all said and done. That continues to be our goal. If, for some reason, that becomes difficult or impossible to do, then I think we will look at what can we and what can we not potentially conclude from the study at that stage of completion. But let us get there when that becomes necessary because at this point, our goal continues to achieve ideally complete enrollment in that side.
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Charles Cliff Duncan, Cantor Fitzgerald & Co., Research Division – Senior Analyst [14]
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That’s helpful, Norbert. But I guess I assume that you’re thinking about different statistical analysis, plans and things that you would do to replace or deal with missing data or patients.
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Norbert G. Riedel, Aptinyx Inc. – President, CEO & Director [15]
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Yes. Of course, right. And it has to do with missing data, miss — patients, it has to do with maybe increasing dropout rates, depending on how things go. And so, of course, in close dialogue with our clinical team, our statisticians and ultimately, if necessary, with the agency, we will see if and how that data needs to be treated differently. We are, of course, monitoring and recording that meticulously. So that any deviation from the initial plan is captured properly and becomes part of how we look at the data.
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Charles Cliff Duncan, Cantor Fitzgerald & Co., Research Division – Senior Analyst [16]
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Okay. But you believe that towards the end of the year or consistent with your previous timing, we’ll be able to glean some takeaways from that data and consider going forward?
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Norbert G. Riedel, Aptinyx Inc. – President, CEO & Director [17]
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Look, I answered that by saying that is very much the hope we have. With the fluidity that we are currently experiencing with COVID-19, I don’t think I can go as far be definitive about that. But certainly, it continues to be our goal.
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Charles Cliff Duncan, Cantor Fitzgerald & Co., Research Division – Senior Analyst [18]
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Yes. That’s fair. Everyone has very similar challenges.
Let me ask a follow-up question, perhaps to Ashish. When you consider the changes with regard to 2925 and 458, I believe that you had guided to having cash into 2022. And I guess could you provide us a little bit more granularity on that cash guidance? If if those 2 programs were to be stopped, say, for 1 year, what would that do to the balances, cash balances?
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Ashish Khanna, Aptinyx Inc. – CFO & Chief Business Officer [19]
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Yes. So it’s no surprise that the bulk of our spend is on R&D and on our ongoing clinical studies, in particular, and those 2 pain studies, chronic pain studies are our largest ongoing studies. As enrollment of those studies is paused, it’s reasonable to expect that our spend will be reduced for a period of time. We’ll continue to guide that our cash should get us into 2022, as to deciding how far into 2022 or giving any updated guidance, I think we
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on the anticipated timing of readout for those studies once we have a sense, once they’ve restarted enrolling patients. Really, at this point, it’s probably too difficult to far for me tell.
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Operator [20]
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Our next question comes from Laura Chico of Wedbush Securities.
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Laura Kathryn Chico, Wedbush Securities Inc., Research Division – SVP of Equity Research [21]
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I guess 1 on 783, and I think you’ve kind of talked to this already, but if you could just kind of maybe clarify. One on, what was your assumption around discontinuations or dropouts for the study?
And then two, just given the patient demographic here, how are you thinking about the heterogeneity, I guess, of the unfolding situation here and kind of the impact on the variability in the 783 study?
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Norbert G. Riedel, Aptinyx Inc. – President, CEO & Director [22]
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Okay. Laura, thank you so much for that question. Kathryn, you want to kick it off with an answer?
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Kathryn King, Aptinyx Inc. – SVP – Clinical Development [23]
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Yes. Thank you. So I think in terms of dropout, leading — in the time leading up to the issues with COVID-19, we were tracking pretty well towards plan in terms of dropout. I think we’re watching that very carefully as the situation unfolds. And we are working with individual sites to address individual situations where we can to support continued participation in the trial in ways that make sense.
With respect to heterogeneity and variability, I think what we’re doing is making every effort to document both in our files, but also in our electronic data set, the ways that different measurements might be taken during this time, be they variations in time or variations and method so that we can factor that into our analysis in the event that it becomes important.
So again, I think it’s careful attention to the details, careful documentation and then making sure that we’ve got the ability to factor those into the analysis going forward.
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Laura Kathryn Chico, Wedbush Securities Inc., Research Division – SVP of Equity Research [24]
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Okay. And then I guess 1 quick follow up, if I may, then. What kind of signal are you looking for before you would restart enrollment? Is this just purely related to the site availability, maybe shelter in place orders, a confluence of multiple things? But I guess, when — what would you need to see in order to restart enrollment?
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Norbert G. Riedel, Aptinyx Inc. – President, CEO & Director [25]
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Kathryn, I think you can up take that, too.
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Kathryn King, Aptinyx Inc. – SVP – Clinical Development [26]
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Sure. Yes. I think many of the factors you’ve described, right, the ability of site staff to go to work. The ability of patients to attend visits, the willingness to leave the home and a feeling of security and doing so. I also think just getting things back to normal in the rest of everyday life is going to be a big factor to our ability to restart. We do intend to use this time and pause to position ourselves well for a restart. So as we monitor conditions, both in the clinical trial world and in the broader world, as we consider geographic differences in terms of the times that different locals may be able to get back to work, we’ll take that all into account as we make those choices. But again, close communication and monitoring as we see the situation develop.
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Operator [27]
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Our next question comes from Ritu Baral of Cowen.
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Lyla Youssef, Cowen and Company, LLC, Research Division – Research Associate [28]
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This is Lyla on for Ritu. My question is on the 2925, and I was wondering if you could provide just a little more granularity on how enrollment was progressing suppliers which is pending the trial. Have you seen any increases in drop outs for the patients that were already enrolled, meeting up to COVID?
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Norbert G. Riedel, Aptinyx Inc. – President, CEO & Director [29]
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Okay. Great. So you know, of course, that these studies started late last year. And as I mentioned in my prepared remarks, the sites are up and running and we are screening. I think it is not easy to give you a sense of, has it significantly changed. It clearly has, just like the other studies impacted sites and has had, therefore, a resulting impact on number of patients. But overall, since the study is a little early on, I don’t have as good a measure on that as we, for example, have on PTSD study.
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Lyla Youssef, Cowen and Company, LLC, Research Division – Research Associate [30]
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Got you. And then if you don’t mind if I just follow up with — you briefly mentioned the supply that you’re increasing your supply to meet the need. Do you currently — given that the trial is suspended right now, do you currently have enough supply of 2925 to meet what you would eventually need if you were to complete the trial?
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Norbert G. Riedel, Aptinyx Inc. – President, CEO & Director [31]
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Yes. This is great, great question. I was rather brief in my prepared remarks, but I’m going to have Andy elaborate a little more on that because we have really paid a lot of attention to making sure we don’t have any disruptions in supplies. And so I hand it over to Andy to add further on to.
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Andrew Kidd, Aptinyx Inc. – COO [32]
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Yes. Thanks, Norbert. Yes, so we actually have sufficient supply for all 4 of our studies of investigational products and placebo already manufactured and in the U.S. So to Norbert’s point, as you all know, we do use contract manufacturing organizations outside the U.S. We were quite proactive, I think, in manufacturing supplies ahead of time. And then when the situation started building in February, we just made sure everything was shipped over to the U.S., just in case. Obviously, that situation unfolded as, unfortunately, it has. So, yes, we have all the materials we need. For the most part, they’re packaged and ready to go. Some are still to be packaged, but that’s all done in the U.S. fairly short-lead time. So we’re very comfortable.
In the case of a very long delay, which at this point, I don’t think we envisage, of course, we would have issues with shelf life and things like that. But I think with reasonable scenarios that are being discussed externally, we feel comfortable that we have the supply we need.
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Operator [33]
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Our next question comes from Gary Nachman of BMO Capital Markets.
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Gary Jay Nachman, BMO Capital Markets Equity Research – Analyst [34]
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Hope you’re staying safe and healthy during this pandemic. Just back to 2925, can you potentially reduce the overall size of the studies from what you previously targeted if you need to do that? And when you resume enrollment, does it not change the statistical analysis in any way, even if there’s a long delay? And is DPN even more challenging than fibro, if diabetic patients could be compromised with COVID-19 just in terms of having that additional risk factor?
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Norbert G. Riedel, Aptinyx Inc. – President, CEO & Director [35]
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Okay. So I think we’re going to do that in a team effort here. I kick it off by — first of all, Gary, thanks for the question. As we have actually shared with you on several occasions, the current Phase IIb studies in DPN and fibromyalgia are built on the information we obtained in the previous Phase II studies we conducted. And we have powered them to achieve statistical significance on what is a clinically meaningful endpoint in these studies. And so, I cannot see at this point that we would reduce the size of the study because the fundamentals of the goal of what we want to accomplish here have not changed. It might have become a little bit more complicated in the ultimate analysis of the data, but I do not foresee at this point that we will change the study per se and the size of the study as a result of COVID-19.
Who wants to tackle the next one? Is it harder?
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Andrew Kidd, Aptinyx Inc. – COO [36]
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Yes. With the DPN population. Yes, I mean, I think that’s certainly concern is that the diabetes is believed to be a risk factor, I guess, as more data comes in, we’ll learn more about how much that’s the case and whether diabetic patients need to take additional precautions. And so clearly, yes, as compared with fibromyalgia, which is not a known risk factor, it could be that there’s an ability to restart the fibro study ahead of the DPN study. I think we’ll just have to keep an eye on how things evolve in general. And as life gets back to normal, what are additional steps that are still needed for people in vulnerable populations, which, of course, we don’t yet know.
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Gary Jay Nachman, BMO Capital Markets Equity Research – Analyst [37]
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Okay. And I guess whether it’s with 783 or 2925, what’s an allowable period for starting re-enrollment in studies that you stop for the study and data to remain viable? Is there any sort of time frame on that? I know — I mean everyone’s going through it across the industry. So I’m just curious, if it’s weeks versus months versus a year, like is there a area that you think is allowed as part of these studies?
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Andrew Kidd, Aptinyx Inc. – COO [38]
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I think a lot of this will depend on the general experience across the industry. I think the FDA guidance and the EMA guidance those that have come out generally taken the view that these are very unprecedented times, and there isn’t a clear playbook, and it’s a lot of things are case by case. And so I think that’s — the extent to which some of these unusual situations are kind of tolerated in a way that they might not normally be within a study is something that we just don’t yet know. But I think we were encouraged that the guidance seemed to suggest there was going to be significant flexibility, and we would read that as tolerating or allowing for polices of enrollment that might not normally occur within a study and accommodating those.
These studies are not designed as registration studies. And so ultimately, a lot of that will probably be within our own control to determine in consultation with the right experts.
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Gary Jay Nachman, BMO Capital Markets Equity Research – Analyst [39]
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Okay. And then just last question. Are there any overlapping sites across the studies, whether it’s DPN and fibro or PTSD? Or I’m assuming Parkinson’s is going to be maybe different site. But so if there are certain sites that come on board sooner, are there certain studies that you might be able to restart sooner than others across the board?
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Norbert G. Riedel, Aptinyx Inc. – President, CEO & Director [40]
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Yes. Thank you, Gary. Kathryn, can you take that?
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Kathryn King, Aptinyx Inc. – SVP – Clinical Development [41]
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Yes. There is some overlap in terms of the sites, but I think the driving factor is going to be the ability of those sites to do work and an assessment of care for the well-being and welfare of patients who may be enrolled. So I think we’ve had really good discussion here today about the differences in terms of patients with Parkinson’s, patients with DPN, and we’ll factor that into the decisions in terms of when we’ll get started, too.
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Operator [42]
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(Operator Instructions) Our next question comes from Jessica Fye of JPMorgan.
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Yuko Oku, JP Morgan Chase & Co, Research Division – Analyst [43]
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This is Yuko on the call for Jessica. In the PR, you mentioned certain measures you were taking to support continuity of patients enrolled in the 2925 clinical studies. Could you elaborate on what the specific measures are?
And then following up on the question asked earlier in the call, could you help us think about the quarterly R&D spend following temporary suspension of the new patient enrollment in the 2925 and 458 studies?
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Norbert G. Riedel, Aptinyx Inc. – President, CEO & Director [44]
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Kathryn, I’m going to have you answer the question. Are you sure you asked it related to 2925? Or was it related to 783?
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Yuko Oku, JP Morgan Chase & Co, Research Division – Analyst [45]
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It’s 2925.
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Norbert G. Riedel, Aptinyx Inc. – President, CEO & Director [46]
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Okay. Kathryn, can you take that, please?
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Kathryn King, Aptinyx Inc. – SVP – Clinical Development [47]
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Yes. I think let me answer it kind of broadly and generally for all the patients who will continue in our studies during this time. We’re working carefully with individual sites, the investigators and their staff to address local concerns and mobile constraints and also to comply with operating procedures required by their institutions and their clinics. And so some types of things that we might employ could be delivery of study drugs, could be changing in the timing of visits to ensure that there aren’t contact with large number of people in a waiting room or something like that. We also may allow some remote visits where that is appropriate for the design of the study and the sort of data that’s being measured. But again, we’re customizing those to the individual challenges that both sites and patients are facing and trying to be sure that we respond to those needs uniquely and specifically.
Norbert back to you.
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Ashish Khanna, Aptinyx Inc. – CFO & Chief Business Officer [48]
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Yuko, this is Ashish. With regard to spend projections, again, I think that we have been guiding toward the durability of our cash, which we think is quite strong. We topped up the balance sheet with the financing in early January. That serves us well and continues to serve us well as we look at cash under a number of different scenarios that you can imagine that we’ve modeled out with regard to how long this pandemic impacts our enrollment efforts across these studies. And we’re quite confident across those scenarios that the cash that we have gets us into 2022, whether that’s well into 2022 or even all the way through it, really has to be determined as we understand the path out of the pauses.
In the meantime, we would expect reduced spend on R&D as that R&D spend is largely tied to enrollment of patients in the clinical studies, which, of course, is paused temporarily at the moment. So we would expect a reduction in that for the duration of the pause and possibly even for a period as we’re restarting up that enrollment.
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Operator [49]
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I’m showing no further questions at this time. I’d like to turn the call back over to Norbert for any closing remarks.
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Norbert G. Riedel, Aptinyx Inc. – President, CEO & Director [50]
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Thank you, operator, and thank you all for your questions and for being on the call. We look forward to communicating further updates to you as they become available.
We appreciate your time and your attention. And in particular, under these circumstances, please stay safe, be well. And enjoy the rest of your day.
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Operator [51]
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Thank you for joining us today. You may now disconnect.
