Good afternoon, ladies and gentlemen, and welcome to the aTyr Pharma Third Quarter 2021 Conference Call. At this time, all participants are in a listen-only mode. Later, we will conduct a question-and-answer session and instructions will be given at that time. And to ask a question during the session, you will need to press Star 1 on your telephone. If you require any further assistance. And as a reminder, this conference is being recorded for replay purposes. It is now my pleasure to hand the conference call over to Ashlee Dunston, aTyr’s Director of Investor Relations and Corporate Communications. Ms. Dunston, you may begin.

Thank you, operator, and good afternoon, everyone. Thank you for joining us today to discuss aTyr’s third quarter 2021 operating results and corporate update. We are joined today by Dr. Sanjay Shukla, our President and CEO; and Ms. Jill Broadfoot, our CFO. On the call, Sanjay will provide an update on our corporate strategy, including our clinical program for ATYR1923 and our research and discovery programs in Neuropilin-2, including our preclinical program for ATYR2810. Jill will review the financial results and our 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 facts, 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.

Thank you, Ashlee. Good afternoon, everyone, and thank you for joining us for our third quarter 2021 results conference call. The third quarter was a major inflection point for tire in which we demonstrated clinical proof of concept for ATYR1923 or 1923 and that our novel tRNA synthetase biology platform has the potential to treat serious diseases. The positive results reported from our Phase Ib/IIa study of ATYR1923 in sarcoidosis our initial interstitial lung disease or ILD indication suggests that ATYR1923 could be a transformative therapy for patients by reducing steroid burden while also improving lung function and measures of sarcoidosis symptoms. Since we reported these findings, we have had the opportunity to share them with many of the groups that played a key role in supporting us to get to this point, including the principal investigators, Kyorin Pharmaceutical, our partner for ILD in Japan. The foundation for sarcoidosis research with whom we collaborated to conduct the study and even some sarcoidosis patients. And in each case, the feedback has been outstanding. This enthusiasm reinforces our confidence in the strength of the data, and we are more excited than ever to proceed with the development of ATYR1923. We look forward to advancing ATYR1923 to a registrational trial in pulmonary sarcoidosis next year, which will bring us one step closer to delivering a potential new treatment to sarcoidosis patients with clinically meaningful outcomes. As we begin, I will summarize a few highlights since we last spoke in August. We announced positive results from a Phase Ib/IIa, multiple-ascending dose placebo-controlled study of ATYR1923 in 37 patients with pulmonary sarcoidosis. Bank was safe and well tolerated at all doses with no drug-related serious adverse events or signals of immunogenicity. Additionally, the study demonstrated consistent dose response for ATYR1923 on key efficacy endpoints and…

Thank you, Sanjay. Cash, cash equivalents and investments as of September 30, 2021, were $116.4 million. This includes net proceeds of approximately $80.6 million raised through a public offering in September, where we received strong support from several of our existing shareholders and also generated interest and demand from high-quality institutions who are newcomers to tie. Research and development expenses were $5.1 million for the third quarter of 2021, which consisted primarily of expenses related to ATYR1923, ATYR2810 and our discovery program. General and administrative expenses were $2.6 million for the third quarter of 2021. Common shares outstanding were $27.8 million and fully diluted shares were $29.6 million as of September 30, 2021. With our updated cash position, clean balance sheet and support from several high-quality, long-term focused investors, we’re in the strongest position that the company has been in quite some time and allows us to move the company forward. The combination of capital and clinical proof-of-concept data in hand situates us to drive meaningful value for the company. Now I’d like to turn the call back over to Sanjay before we open the dog to Q&A.

Thanks, Jill. Well, our recent clinical readout represents years of hard work and intense dedication to developing and advancing our tRNA synthetase biology platform to one that can generate new therapeutic targets and from which we can develop a potential new class of medicines. While we’re very excited and encouraged by these recent results for 1923, we’re even more excited for what is still yet to come. So with that, we appreciate your interest, continued support. At this time, Jill and I will be happy to take your questions.

And as a reminder to ask a question, you will need to gain that is Tan. And our first question is from Kennen MacKay of RBC Capital Markets.

Congrats on a really transformative quarter. Two questions. Sanjay, maybe first, I would imagine the data from 1923 in pulmonary sarcoidosis had, to your point, sparked a huge amount of interest. Just thinking about this asset and some of the other indications there, are there any thoughts around potentially partnering this asset? And if so, can you just help us understand sort of what that could look like. And then next, just thinking about the potential registrational path in pulmonary sarcoidosis. You mentioned starting a potential registrational trial next year. Just wondering, from a registrational perspective, what endpoints we should be considering for an approval trial...

Thanks, Kevin, for the questions. So certainly, our data is being viewed as probably the -- well, maybe the best sarcoidosis data really produced in the last, say, 15 years. I think the fact that we are the only therapy that has been able to, frankly, reduce steroids and see this magnitude of clinical improvement is garnering a lot of interest not only from experts, but as you can imagine from partners as well. It is something that we can’t comment too much about with regards to partnering activities. We’re going to do what’s right here to make sure that we continue to drive value for this program. As you’re aware, biotech companies like us can sometimes do that on our own and sometimes we can do that through partners. If it makes sense for us and shareholders, we may pursue those kinds of options. But at this point, we are really bullish on the data, our findings. We have a really strong win behind us at this point with regards to the endpoints, which was your second question. The endpoints that we looked at hitting on really all of the key endpoints, steroid reduction, FVC improvement and also the rather large symptom improvement gives us really, really great options when we talk to the regulators. We know there’s guidance from the FDA talking about how symptoms and meaningful outcomes like that are really important for new therapies. We also know that there’s other guidance saying we need better therapies when the standard of care is toxic in this environment that we’re in with ILD, we’ve also demonstrated that, that could also be an effective strategy. And then the FVC improvement we saw, as I mentioned, more than 2.5% is viewed as significant in the eyes of the clinicians to see 2.8%, 3.3% and our highest dose. This is better and very competitive to, as I mentioned, the types of therapies that have been approved for IPF mostly. So we have great options here. The delta that we have and delta of improvement gives us a lot of ability to carefully craft a trial and hit a p-value in a large registrational trial. So I will say that stay tuned with regards to these endpoints. We have 3 very, very good options to discuss with the FDA. And I do think that we are in an extremely favorable position to argue for any of these and really work closely with them with the FDA, for example, to determine what do they think is the most important. When you talk about patients and providers, they really want to see symptom improvement and they want to see that improvement, while at the same time removing steroids. And as I said, we’re really the only therapy that’s been able to do that thus far in ILD.

Thank you.

And our next question is from Zegbeh Jallah of Roth Capital Partners. Please go ahead.

Hi. Thanks for taking my questions. I think I just have a couple of quick ones here. The first one is just about 1923. Zane, you prepared marinated sharing the data with Kirin. Are you -- are they prepared to actually start the Phase III study alongside you? Or will there be a little bit of a delay waiting for them? Or I suppose, is it possible to start recruitment in the U.S. to expand into the theater. Just kind of wondering if that could impact the timing of the study since you’re waiting for them? And then the second part is just about 280. Just want to get a sense of what needs to be completed for the IND. What are some things that are under consideration in terms of the dose and the indications, how you’re thinking through that? And then the last bit, are you working alongside also kind of decide how to move forward with the program?

Yes. Thanks, Zika. Certainly, with your first question around Kyorin, there’s no delay. There’s no waiting. If anything, they’d like to get started tomorrow probably. As you are aware, our current trial had some impacts with regards to COVID in the middle of the trial that we were able to battle through and get the trial enrolled. Kiran themselves have completed the necessary work that allows them to join our trial immediately. So we will be looking to launch at the same time with Kyorin here in a trial together. So really no delays related to that partnership. Your second question was around 2810. I would say right now, we’re in the final stages of honing in on the indication or at least the phenotype of indication to look for in a trial next year. We’ve seen a lot of excellent data over the last two years with 2810, we pointed to efficacy in triple-negative breast cancer, lung cancer, we’re really completing, I would say, now the indication selection process. But what you can also appreciate is many early cancer trials also sometimes take a basket approach where they look at specific environments, for example, where Neuropilin might be highly enriched, so it could be across multiple solid tumors. We are right now working very closely with the key opinion leaders in neuropilin biology but -- and also those who have more of a cancer biology focus. This recent data around our mechanism at ITC, obviously, is going to really inform us also around looking at that tumor microenvironment. So much in the same way that we developed ATYR1923, we are taking a very curated, careful crafted approach to advancing 2810 doing it by being data-driven. And I really like the setup here for 2810 to potentially be our next real opportunity at aTyr. In particular, because of what we’re learning around Neuropilin biology and some of those aspects around TAMs and EMT that I discussed.

Thank you.

Thanks and congrats on the progress. And our next question is from Prakhar Agrawal of Jones Trading.

So firstly, on the trial design for 1923. In terms of the potential primary endpoints for registration drug, what is your preference between steroid reduction, FVC and symptoms? What I’m trying to understand is among the 3, which endpoint do you think has the least risk? And secondly, on development plans for other ILDs. Any details on the timing for moving forward? And what are the gating factors for a potential drill start?

Okay. You broke up a little bit there for car in the second half, but I think I got it. So the first question is around preference. I mean, I honestly, we’ve been in – this is a situation where I think for me as a clinician, I look at symptoms, and I also look at the magnitude of improvement we saw in our symptom scores. It’s really something that I think jumps off the page. So that gives us a lot of room if we want to actually power a study and hit a minimal clinically important difference there. So a lot of opportunity with symptoms and symptom improvement. We also have to look at regulatory precedents that IPF drugs have been approved based on FEC. We have that also because we’ve hit a threshold in a very short study threshold that PIs think would be also dramatic to see 2.5% over the course of a year, we’re seeing north of 3% in six months. So two very, very good options there. With regard to steroid reduction, we also are hitting a threshold that is really important. But we have to understand that there isn’t necessarily as much precedent when you look at steroid reduction as an endpoint compared to FVC. And if you think about steroid reduction versus symptoms, most patients and providers really want to see that symptom benefit, not just a steroid reduction without that. So maybe that gives you an idea of the lean here. But again, we have three really good options here to have an informed discussion with the FDA and worldwide regulators. But I would say right now, the symptoms are the area that we really, really like about potentially pushing that forward symptom improvement. Your second question was, I think, really around an IND filing. Was that for 2018?

No, sorry. The same question is on the plans for other ILD indications, CHL. Yes, any details on the timing for moving forward? And what are the gating factors for a potential trial start right now?

Yes. I mean we are game ready to be able to move into some of the ILD indications. But we want to make sure that we focus and get sarcoidosis in that trial launch and running well first. At the same time, as you’re aware, we produced really good efficacy data in animal models, for example, in scleroderma, ILD. So with our current data being now starting to be talked about and consumed by more pulmonologists in other areas, we are getting interest in a lot of interest in connected tissue disease will be in pneumonitis. Even IPF because IPF, you still have quite a bit of inflammation that patients have trouble with on top of perfinidone or nintedanib. So there’s no shortage of interest. For us, we just want to remain focused, move our core value -- the core value here in sarcoidosis. But I do think that we would be able to quickly jump into other indications. Right now, I would say stay tuned about another IND in the work for another non-sarcoidosis ILD. But I want to make sure that we get sarcoidosis launched crisply and executed well first, and then we can get into those other indications.

Thank you.

And our next question is from Yale Jen of Laidlaw & Co. Please go ahead.

My first question is that I know that you mentioned – you addressed earlier in terms of this the drug could be a potential for partnering opportunity. But still, given the small patient size or more limited the reach for the physicians, was that something that you can also potentially market it by yourself? And what will be the thoughts if that’s the potential routes you have to take? Any thoughts on that? And any comments on that?

Yes. Thanks, Neil. We have the capabilities and we’ve already demonstrated the ability to execute and move a really, really difficult indication forward. So I have no doubt that we can actually move this forward and market and commercialize the drug ourselves. We’ve really the world leader, I would say, right now in a non-IPF therapy here. So we have entirely the focus and mindset to take this forward ourselves. At all times with partnering, you have to just sort of weigh some of those way that interest. You have to have listened to those sorts of forays towards us. I would say that they’ve it’s never been hotter, if you will. Obviously, data like this is going to generate a tremendous amount of interest. So you can look at those companies that are in the respiratory space. This is an extremely attractive opportunity having worked in those sort of large organizations prior to a tire. This is built very, very well to be a late-stage asset really for anybody. And because it has that transformation transformative potential, I think any commercial team would also look at this as a potential type of game changer for their franchise there. But thinking about how we want to move forward, we know that this is an extremely valuable asset, and we are prepared to really take it all the way here. That’s our mindset at this point.

Okay. Great. That’s very helpful. And maybe one more short questions, which is I assume the next step really is you need to speak with the agency and carve up understanding their thoughts and the cover of the registration trial design. Do you guys have a time line in terms of when that meeting might take place? Would that be in the fourth quarter or more likely in the first half or first quarter of next year?

We’re moving as quickly as possible. As I said, we’ve been quite busy the last, say, couple of weeks here with talking to investigators from around the world. I will say, stay tuned. We are working very, very quickly here to get with the FDA because we do want to start this trial quickly next year. Patients can’t afford the wait. There’s a lot of interest to move into a Phase III trial from sites, clinicians around the world. I’d say we’re probably up to 50 to 60 centers that want to commit now to entering into our trial. So the excitement is there. We’re not going to slow down our regulatory efforts, and we will be meeting with the FDA as quickly as possible.

Okay. Great. And again, congrats on the very good quarter. As I said, just more transformative quarters.

Thank you, Yale.

And our next question is from Joseph Bananas of HC Wainwright. Please go ahead.

This is Emanuela on for Joe. So with regards to the data, thank you for sharing the feedback of the investigators. And I was wondering, I know this is a small study, but as you look at baseline characteristics? Or are there any biomarkers that could potentially predict duration in SBC.

That’s a great question. A predictive biomarker progression is something they have all of the experts have been searching for worldwide. -- region to region, you may have a biomarker that an individual or a group of experts may favor more than others. I will say that what we tried to do when we looked at our biomarker panel is taken into account everybody’s favorite. What I’m really encouraged by is we see consistency regardless of which biomarker people like the most. We’re controlling all of them. We’re doing a great job with regards to, for example, controlling IL-6. Again, I don’t want to go into too many details about each individual biomarker. We have a very important abstract and a publication that we’d like to get out. So I do want to save a little bit of powder for, I think, what would be a major medical journal. But the point -- the key takeaway here is when you look at the cytokines we’ve looked at previously, IL-6, TNF, interferon gamma, MCP-1, IP-10. These are the markers that we followed years ago in our animal studies that the drug seemed to impact. These are the markers that were highly upregulated in, say, COVID pneumonia patients that AYTR1923 did a substantial job of knocking down. And I think what you’re going to find is the same findings in this study. So this is why Hire spends a lot of time really understanding mechanism, and we talk a lot about biology and mechanism. That way, we derisk things as early as possible so that when we do have clinical results, well, then we’re not -- we’re seeing the kind of results the 1923 program is produced. So I’d say stay tuned for that Emanuela, but I’d probably refer to you to our recent ERS publication, which if you take a look at the box and whisker plots from those COVID pneumonia patients, we’re going to have a similar kind of presentation hopefully at a medical conference that will show that consistency again now in sarcoidosis patients.

Got it. And with regards to the potential registrational trial in sarcoidosis, again, you already shared your thoughts on the endpoints. But can you give us a sense of the expected size and duration of the trial?

Yes, that’s a great question. So when you look at, for example, the magnitude of our effects in, say, lung symptoms, improving long symptoms, we can basically model that if we wanted to power a trial to see a significant signal, for example, in symptoms, what would the trial look like? Right now, ballpark, as we’ve said previously, we’re looking at about 200 patients. We’ve always thought that, that would be kind of the ballpark ahead of data. Now that we have the data we feel even more confident that we’re going to be able to plan for a well-powered trial with numbers around there. Again, it’s all dependent on interactions with the agency. So I can’t say definitively until we finish that. But I will say that we’re looking at a trial somewhere in that ballpark of around 200 patients. From a duration standpoint, this was a 6-month study. There’s a suggestion that if we run a longer study, we may see even more worsening in placebo. So I do think to see a potentially larger effect and certainly a more durable effect, we will be looking at a longer trial. And right now, we will be discussing somewhere between a 9- to 12-month trial with the regulators. So again, that’s dependent. I want to caveat this dependent on that -- those interactions. But right now, those are our draft plan here.

Thank you.

And our next question is from Hartaj Singh of Oppenheimer. Please go ahead.

Hello, everyone. This is a [inaudible] for Hartaj today. Congrats on all the progress and just from us, could you give us an update for -- or any color on the upcoming milestones from Kyorin, especially after your discussions with them. Just on the timing since those are development, regulatory and in the future sales related. For instance, after ATYR1923, moves to the next stage of development next year. But for this year, could we still expect some regulatory milestones maybe? And our second question is about the IND filing for HR-2810. I’m just wondering, and I believe you also have a partner for Manufacturing Lonza. Could you comment on CMC, what sections you have completed and what you need to complete? Just trying to get a sense of where you are with manufacturing. Any color on this would be very helpful.

Yes. So the first question around Cure and milestones, so I will point out. While I can’t get into specific numbers around those milestones. I will point out that the bulk of the remaining milestones, which are approximately $165 million are really, as we’ve said this before, largely development focused largely on the development side, the majority of those milestones. So now as we start to develop a compound with Kirin, we will be unlocking those milestone payments. Again, difficult to say when they start to hit, it’s predicated on developing, getting the trial up and running and moving it along with Kyorin. So I think we’ll have a better idea where I can talk to you about when those milestone payments will be coming once we actually get the trial organized and launch activities planned with Kyorin. With regards to 2010, the IND, what I can tell you is things are on track. You asked specifically around Lonza. Yes, you are right. Last year, we signed a deal with Lonza to manufacture 2810. We were fortunate to do that, perhaps ahead of some of the supply chain issues that a lot of sponsors are facing right now. We got in early, we got things locked down. And we also qualified for some aspects of an accelerated pathway to manufacture 2810. That’s going to allow us to again hit our time lines and allow us to start a Phase I cancer trial in 2810 because we made that investment early with Lonza, there are no delays, no issues thus far, and we expect to not have CMC in any way, be a critical path activity or in danger of things around starting a cancer trial with 2810.

Thank you so much, Sanjay.

And there are no further questions at this time. I will now turn the call over back to Dr. Sanjay Shukla, our President and CEO, for his closing remarks.

Thanks again. Excellent questions today. Obviously, a real important inflection. One of the most important inflection points in aTyr’s history occurred last quarter. We are really gratified by the response with how we’ve been able to move this program forward, and we really are excited about taking it now to this next stage here. So I really appreciate everyone’s interest. We will be in touch in the near future. everyone be well. Thank you.

And this concludes today’s conference call. Thank you for participating. You may now disconnect.