Good afternoon, ladies and gentlemen. Welcome to the aTyr Pharma First Quarter 2020 Conference Call. At this time, all participants are in a listen-only mode. [Operator Instructions] As a reminder, this conference is being recorded for replay purposes. It is now my pleasure to hand the conference over to Ms. Jill Broadfoot, aTyr's Chief Financial Officer. Ms Broadfoot, you may begin.

Thank you, and good afternoon, everyone. Thank you for joining us today to discuss aTyr's first quarter operating results and corporate update. We are joined today by Dr. Sanjay Shukla, our President and CEO. On the call, Sanjay will provide an update on our corporate strategy, including the clinical development of ATYR1923 and our research program in Neuropilin-2 or NRP2 and tRNA synthetase biology. I will then review the financial results and our current financial positioning before handing it back to Sanjay to open the call up for any questions. Before we begin, I would like to remind everyone that except for statements of historical fact, the statements made by management and responses to questions on this conference call are forward-looking statements under the safe harbor provision of the Private Securities Litigation Reform Act of 1995. These statements involve risks and uncertainties that can cause actual results to differ materially from those in such forward-looking statements. Please see the forward-looking statement disclaimer in the Company's press release issued this afternoon as well as the risk factors in the Company's SEC filings and included in our most recent annual report on Form 10-K and quarterly reports on Form 10-Q. Undue reliance should not be placed on forward-looking statements, which speak only as of the date they are made, as facts and circumstances underlying these forward-looking statements may change. Except as required by law, aTyr Pharma disclaims any obligation to update these forward-looking statements to reflect future information, events or circumstances. I will now turn the call over to Sanjay.

Good afternoon, everyone, And thank you for joining us for our first quarter 2020 results conference call. Before we begin, I would like to say on behalf of aTyr and our employees that we stand in support of all of our healthcare providers, essential personnel, partners, patients and community as we continue to work through the ongoing Covid-19 pandemic. We acted accordingly to implement a plan to ensure the safety of everyone involved with our clinical and research programs, while minimizing disruption to our business operation. We continue to abide by government directives and operate our business remotely in order to play our role in minimizing the spread of the virus to our employees and their families and ease the burden on our healthcare system. Now let's get started with our quarterly review and corporate update. During the first quarter of 2020 and subsequent period, aTyr progressed the development of our clinical program for ATYR1923 including entering in major collaboration for expanded development and announcing a new trial in Covid-19 patients. We also advanced our pipeline of discovery programs and strengthened our balance sheet enabling us to further advance these programs towards important and potentially value creating milestones. As we begin, I'll summarize the key highlights from the first quarter and subsequent period. We announced the Phase 2 trial of in 1923 Covid-19 patients with severe respiratory complications following FDA acceptance of an investigational new drug application. We entered into a collaboration and license agreement with turned Kyorin Pharmaceutical for the development and commercialization of 1923 for interstitial lung diseases or ILD in Japan for up to $175 million. We published two abstracts in the American Journal Respiratory and Critical Care Medicine that would be presented at the upcoming American Thoracic Society International Conference. We announced the appointment of Dr.…

Thank you, Sanjay. Total revenues were $8.1 million for the three months ended March 31, 2020, consisting primarily of licensing revenue from the Kyorin Agreement. Research and development expenses were $3.6 million and $3.3 million for the three months ended March 31, 2020 and 2019, respectively. The increase for research and development expenses was due primarily to the progression of our 1923 Phase 1b/2a clinical trial in pulmonary sarcoidosis patients which was initiated in December 2018. General and administrative expenses were consistent between quarters at $2.6 million and $2.5 million for the three months ended March 31, 2020 and 2019, respectively. As of March 31, 2020, aTyr had $49.8 million in cash, cash equivalents and investments, which is consistent with prior guidance. Now I'd like to turn the call back over to Sanjay before we open it up to Q&A.

Thanks Jill. Before opening the call for questions, I want to reiterate our commitment for clinical and research programs in this difficult time. We aim to potentially help address the global public health crisis by investigating 1923 in a subset of Covid-19 patients. 1923 is not a repurposed therapy as it has been rigorously designed and developed to target aberrant immune responses in the lung. We continue to focus on our mission to develop new medicines for underserved population. And our strong scientific rationale for 1923 not only in pulmonary sarcoidosis but also Covid-19 exemplifies this key corporate principle. We appreciate your interest and continued support and look forward to providing updates in the future. At this time Jill and I will be happy to take your questions.

[Operator Instructions] Your first question comes from a line of Hartaj Singh of Oppenheimer. Your line is open.

Great. Thank you. Thanks for questions and happy to hear everyone is safe and also in all the progress. Sanjay, I know these times are not easy on any of us or all of us. So just a couple of separate questions. One is on the Covid-19 project. Will you have -- the patients should be selecting that you'll be putting on dose three different arms, will they be on sort of background standard of care? I know that one of the things that we reading are that various hospitals have different, sometimes different ways of treating Covid-19 patients especially as they progress from being severe to critical. How will you sort of handle that? And then what kind of background medication like remdesivir or anything else will be allowed? That's number one. And then number two, when -- I know that the safety part of 1923 has -- you've got some good data there but what exactly sort of will you be looking for that data 60 days post dosing to have a good feeling that you can move the project forward. And I just got a couple follow up questions on pulmonary sarcoidosis.

Sure, Hartaj. Yes. Good questions there. So first of all your question was about background therapy and remdesivir has now where it's been approved to be used in these patients. We don't have a lot of data around which subset of patients will be prioritized nor do we at this point see remdesivir really distributed quite a bit at a number of hospitals. So I think that's still being sorted but of course that will be a therapy that will be allowed as it is now considered standard of care. When you talk about some of the other therapies that are being tried out in these patients, we really see our drug positioned a little bit upstream from some of the monoclonal antibodies targeting IL-6, TNF or GMCSF which are being a bit more reserved for the most severe patients. Those patients that are quite often on a ventilator or quite severely sick. So we're targeting those patients that don't require necessarily those therapies. We'd like to actually tune down the immune system before the patients really go into that florid cytokine storm. The other thing is there are still some trials out there where they're looking at hydroxychloroquine but we don't really see our protocol interfering too much with that protocol as we also see some of those protocols winding down at a number of centers. So that's the first question around kind of what other sort of concomitant medications here would be important. And I think remdesivir might be the only one that for our protocol would be allowed. Your second question was really about the endpoints. So it is as the FDA wants us to really make sure that it's safe in these patients. And we've established to a certain degree some safety and tolerability data pulmonary…

Great. Sanjay, another question I have is these are pretty sick patients, so in theory either the low dose or the high dose arm you're seeing you starting to see benefit fairly quickly. Is there some procedure by which it can move very quickly into phase 2? I mean I know that you're in vaccine trials and various human remdesivir, the authorities let larger trials commence almost while the previous trials going on. Is there any such sort of setup with your trial whereby if you see good effects early on that you can progress to a larger trial really quickly?

Absolutely. I mean these are kind of unprecedented times and even from a regulatory point of view, you see things moving very, very quickly. What we're going to be and what we were asked to do on our trial is to have a independent DSMB quickly look at risk benefit. So even with 30 patients, we're going to be monitoring these patients very closely. You see a number of trials and opportunities progress rather quickly with really small signs of activity. I think that's because this is such an unprecedented as I said public health crisis. So we are going to have the opportunity to very quickly evaluate risk benefit even before we get to 30 patients an independent group a look at that and absolutely I think if there are signs of activity we would work closely with the regulators, hear what they have to say and the impression that we get right now is if patients are improving, even small numbers of patients, we have seen examples over the last six to eight weeks of very quick acceleration into advancing these trials.

Great. That's very helpful. And then just going to pulmonary sarcoidosis trial, Sanjay, it makes sense we're hearing from a lot of companies that there have been some slowdowns in clinical trials and the FDA has put guidance in terms of trials are hits these I guess you could call them bumps. Could you kind of just walk us through what is your thinking in terms of how that patient data for the patients discontinued could be made up meaning that you just have to recruit sort of brand new patients to make that up? And I think you mentioned you'd have larger number of patients. And then also what is the sort of the critical rate limiting steps that could keep the Phase 1/2 being finish, let's say before the end of the year. As anything that could be really rate limiting other than just complete lockdown so going on, just any thoughts there. And thank you for all the questions.

Sure. Yes. So I think overall compared to maybe oncology trials and certainly compared to oncology drugs, we've done pretty well. I think some of that had to do with where we were. We sort of just kicked off cohort 3 so we were able to sort of hit pause and we're hopeful to get most of those patients back in screening and re recruited once the sites go live. So we had a healthy queue of patients and our expectation is we were going to finish enrollment towards the end of March there. So once you restart, we're hopeful that we can move quickly to completing that cohort and completing the study. When we look at some of the patients who've missed doses, yes, the FDA has issued guidance saying, look, we understand that there are going to be potentially some holes here and there in the data, but because we've had significant interest in enrolling cohort 3, our thought is we may be able to replenish, if you will, a couple of those patients that we may be worried about how robust their data is with the ability to evaluate the data. So there could be a handful of patients maybe two or three patients that we would consider as I said replenishing into that cohort. We have the ability in our protocol to do this. It is something that currently a number of sites we're speaking to and we have the opportunity to do that. So I would not be surprised if we over enrolled here and it's in essence some of those patients could then, as I said be directed and randomized into our cohort 2 population thereby giving us a nice valuable population of 36 patients as we originally intended. What could be rate limiting aside from just this overall macro, the macro-environment here with Covid-19? It's really how quickly we can get restarted and get those patients because as I said, fit finalizing that cohort we were on track to basically wrapping up over the course of that March. If we restart in June, hopefully it can go right back to that same rate of screening recruitment and enrollment, but there's always going to be that as a potential rate limiter as this is something that it's hard to predict. So the first step is to really get everything open; very happy that a lot of the sites have already message to us that there's an expectation in late May, early June to get back started, get back enrolling patients. I think that's great. That's a great first step. The second thing is completing that enrollment. Once we complete that enrollment, we'll have a better idea if we can hit those timelines you described. We'll provide more succinct guidance on when those top-line results will come out from pulmonary sarcoidosis study.

Your next question comes from the line of Zegbeh Jallah from ROTH Capital Partners. Your line is open.

Thanks for taking my question. Sanjay, just a quick one with regards to how many sites we hoping to have for the Covid-19 study? And then can you share with single site and then expand? Or did you want to get couple of sites up and running first.

Sure. Thanks for the question. So we've written currently up to 10 centers. Honestly, I think our biggest challenges are not going over that. I think there's been significant interest to participate with our study. So we want of course enroll 30 patients and do it smartly. There's no shortage of interest for the number of sites here. Our view is we're going to get started right away and open up sites kind of in a -- as they basically go online as they get IRB approval, as we get the site initiations going -- we'll go ahead and get started. There's a -- as I said no shortage of interest here, I think it's helped the fact that we already were in many of these hospitals with our pulmonary sarcoidosis trial. It's helped that these are pulmonologists who really understand the potential utility of our drug. I think they look at our drug as not repurposed as something that clearly has demonstrated anti-inflammatory effects in animal models. So all of these things have sort of accelerated and keep us moving at a fast pace of getting sites activated. I think the biggest challenge here will be trying to get maybe under that number and maybe some sites might get left out here on how quickly they can actually get started. So I would stay tuned for a site to get activated and enroll patient and then we'll update the site list on things like clinicaltrials.gov as more and more sites get activated here. But we could also very quickly see and we hope to see enrollment move at a quick pace where we may not get to some of those sites that want to participate. It's really up to them with their local approvals and scientific review and IRB approvals at this point more than anything.

Great. This is great. And then just a quick follow up here, are sites being activated faster than they were pre-Covid? Just because of the seriousness of this or things being accelerated?

So as far -- if you compared it to say pulmonary sarcoidosis, yes, I think everything is moving faster. I mean where as in a typical clinical trial you might say, hey, I'd like to get an IRB approval and they put you on the schedule for okay you'll be on the schedule next month for our IRB meeting. These hospital IRB is now are meeting several times a week as requests come in they may create an emergency meeting. So depending on the scale of the crisis at their hospital, we're finding that these sites are moving faster. I think right now it's very difficult times and things are moving at light speed.

I am showing no further questions at this time. I would now like to turn the conference back to Dr. Sanjay Shukla.

Great. Well, thank you today for everyone for joining. The good questions here. Obviously, it's been a very, very productive start to the year for us. The pace at which is really quite amazing at this point. I think how quickly things have moved. We want to stress that we want to keep everyone safe. Hope your families, everyone stays safe in this current crisis. And we look forward to getting back to you in the near future. Thanks everyone.

Ladies and gentlemen, this concludes today's conference call. Thank you for participating. You may now disconnect.