Good afternoon, ladies and gentlemen and welcome to aTyr Pharma’s Third Quarter 2022 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. 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, and good afternoon, everyone. Thank you for joining us today to discuss aTyr’s third quarter 2022 operating results and corporate update. We are joined today by Dr. Sanjay Shukla, our President and CEO; Ms. Jill Broadfoot, our CFO; and Dr. Leslie Nangle, our VP of Research. On the call, Sanjay will provide an update on our corporate strategy, including our clinical program for efzofitimod, and research and discovery programs. Jill will review the financial results and our current financial position before handing it back to Sanjay to open up the call 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, subsequently filed quarterly reports on Form 10-Q and in other SEC filings. 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 2022 results conference call. The third quarter saw the initiation of EFZO-FIT, a global pivotal Phase 3 study of our lead therapeutic candidate efzofitimod in patients with pulmonary sarcoidosis, the most prevalent form of interstitial lung disease or ILD. We dosed the first patient in this study in September meeting aggressive timelines and guidance. Amid current market conditions, we intend to focus our resources on prioritizing EFZO-FIT, which is our highest value program to ensure a timely and successful completion of this study. As we begin, I will summarize a few additional highlights since we last spoke in August. We announced publication of results from the Phase 1b/2a study of efzofitimod in patients with pulmonary sarcoidosis in the peer-reviewed medical journal, CHEST. We presented a poster at European Respiratory Society or ERS International Congress on findings for an antibody for immunohistochemical detection of neuropilin-2 or NRP2 in patient tissue sample. NRP2 is efzofitimod’s binding partner and these findings suggest that this antibody may provide an extremely useful clinical tool potentially aiding in patient selection or stratification. We received FDA Fast Track designation for efzofitimod for the treatment of systemic sclerosis, SSc or scleroderma-associated ILD. We announced a research collaboration with Dualsystems Biotech AG, a company specializing in custom proteomics to identify and validate 10 target – 10 new target receptors for tRNA synthetases from our intellectual property or IP by 2025. This collaboration is a way to potentially accelerate drug discovery and identify new drugs from our platform. And finally, we received a notice of allowance from the U.S. Patent and Trademark Office for anti-neuropilin-2 monoclonal antibodies, which is the first to be granted to our IP estate for this program. We've experienced another…

Thank you, Sanjay. We ended the third quarter 2022 with $79.6 million in cash, restricted cash, cash equivalents and investments. Research and development expenses were $9.9 million for the third quarter 2022, which consisted of product development and manufacturing costs for the efzofitimod and 2810 programs, as well as startup costs for the Phase 3 EFZO-FIT study. General and administrative expenses were $3.6 million for the third quarter 2022. Common shares outstanding were approximately $29 million and fully diluted shares were $34 million as of September 30, 2022. From a balance sheet perspective, we are comfortable with our current cash position, which we believe enables us to carry out the most meaningful value driving catalyst for the company. While running a large global Phase 3 study in a rare disease such as EFZO-FIT is capital intensive we do share a portion of the cost with our partner Kyorin, who is responsible for the cost of all operations and patient costs in Japan and purchases drug supply from us with a small market. And as a reminder, under our agreement with Kyorin, we are eligible to receive up to an additional $155 million in milestone payments, of which the majority are development and regulatory related. As we stated on the call today, we have made some important decisions around our pipeline that will allow us to better manage our cash. At this point in time, we have a financial and strategic plan for the company to fund operations to the data readout for EFZO-FIT. This plan contemplates our current cash balance, the potential for milestones from Kyorin and potential proceeds from the use of our existing equity vehicles. Now, I'd like to turn the call back over to Sanjay before we open it up to Q&A.

Thank you, Jill. We are a highly dedicated team with a track record of exceptional execution and we continue to make outstanding progress with efficient use of capital. We understand that the markets have been challenging as of late and certainly know that they do not -- in any way adequately reflect the intrinsic value of the company, including the data and progress we've generated for efzofitimod, considering its stage of development as of late phase asset, and its potential to address a multibillion dollar market. The prioritization we've discussed today provides us with the ability to ensure adequate resources to successfully advance the highest value driving catalyst for the company. I'll close with a comment recently from one of our top shareholders, who told me aTyr is a platform company that's generating transformative research and clinical opportunity from our tRNA synthetase biology state. This is a company that I think is poised right now to be a leader in an area of interstitial lung disease where as I mentioned, we are the front runner. So we appreciate your interest, continued support. At this time, Jill, and I will be happy to take your questions. Thank you.

[Operator Instructions] And our first question will come from Gregory Renza of RBC. Your line is open.

Hi. This is [indiscernible] for Greg. Congrats on the progress and thanks for taking our questions. Maybe first on the Phase 3 trial, some companies in the space are seeing some clinical trial conduct slow down. Could you just provide some color on what you're seeing around site activation and enrollment cadence as well as your confidence level and the guided timeline of the Phase 3 trial? Thank you.

Sure. Appreciate the question. So it's quite early to necessarily get into projections and the trajectory. But what I can tell you is, the excitement from the PIs worldwide, they've been waiting 20 years, sometimes longer for a therapy like this to get to this stage. So certainly from that perspective, I think you can look at the pace of our regulatory approvals and even the fact that we were able to get a patient enrolled basically about three months from getting the green light from the FDA. This speaks to a rapid sort of interest and uptake to enter our trial. I also think the data we produced is checking the box in all the areas that these experts have been waiting for probably going back really 50 years, a drug that can reduce symptom -- improve symptoms, improve lung function and all doing that while reducing steroids. This has never been seen before. So what do I anticipate? I anticipate a fast start. I'm glad we've started fast with the first patient. I also have seen the quick pace of regulatory approvals. I will be at three sites next week. So I think it's something -- it's off to a fast start here. We're going to have to watch to see as this is the largest sarcoidosis trial, how we really progress here. And I think I'll have a better estimate of that once we get a good 30, 40 centers up and let's allow them to enroll. Let's allow them to enroll for a few months. I think our publication is also really, really important. This is the first major sarcoidosis publication from a clinical trial, I'd say going back to the infliximab data in the 2000. So this is a field that's hungry to actually interrogate efzofitimod, they like the initial data. And I can tell you that patients certainly are responding well in that we are really trying to address their steroid burden. So I will get back to you to see how we're doing here, but early signs here are very, very encouraging.

That's great. Thanks for the color. And then maybe secondly, could you talk a little about your latest development strategy in scleroderma ILD and what do you see as the key differentiation of the mechanism of action that could drive clinical potential in this indication? Thank you.

Great. Yeah. So scleroderma, I think it's something that in honesty it’s an adjacent condition. We are seeing a number of pulmonologists and rheumatologists after seeing our EFZO data in sarcoidosis become very interested. Conversely, we've also received maybe rather surprisingly some nice designations early from the FDA. Scleroderma ILD represents probably the worst form of scleroderma. It's where some of the morbidity and mortality is just really quite dramatic and these patients don't have treatment options. So while we have a good kind of feel from patients and providers and regulators. We have to be careful about thinking about how do we keep our eyes focused on sarcoidosis first. So at this point, I think we are really keeping eyes on sarcoidosis, but it is really encouraging that based on really our data and even going back to our preclinical data, we have animal efficacy showing efzofitimod can impact sclerodermatous plaques and lung inflammation in mice. So that translation is there. So the story is there. But right now, we are staying focused on sarcoidosis. Last thing I'll say is, we are looking more closely at neuropilin expression in scleroderma patients. There's anecdotal evidence that neuropilin is quite upregulated in some of those sclerodermatous plaques, but I think we have some time to look more closely at that. But certainly that is an opportunity that if we had abundant resources and infinite resources certainly is another large market opportunity sitting there for us.

That's great. Thank you very much.

One moment. And our next question will come from Joe Pantginis of H.C. Wainwright. Your line is open.

Hey, everybody. Good afternoon. Thanks for taking the question. So first, just a little more on EFZO-FIT. Obviously, it's early and just wanted to see, I'm not implying these are any rate limiting steps. We wanted to get your sort of early views on how you view the ease of screening patients and any particular geographies even in just the U.S. that you might see outperform even before the European sites come onboard?

Yeah. Hi, Joe. Great question. We've made some tweaks to our protocol based on our last study that I think are going to address some of your points here. Number one, moving into Europe and Japan, there tends to be slightly less -- slightly less steroid administered in those patients. That could have to do with the physiology of those patients, but also there's a larger cohort of African Americans of black patients here in the U.S., which typically those patients have more severe disease and may require more steroids. With that in mind, we've lowered the threshold in this current protocol to allow entry at 7.5 milligrams as opposed to 10. We think this is going to help us enroll and better fits the sort of treatment paradigm of Japan and Europe, where they tend to use a little bit less. So I'll start there and say that's going to help us. I'll also say that compared to the last study where PET scans were used as an inclusion criteria and have now fallen out of favor of five years later, we're now using HRCT, which is going to be a little bit easier to administer and readout more commonly viewed as a better instrument to detect fibrotic patients or not. We want to exclude those patients that are highly fibrotic and bring those patients in that are inflamed. HRCT is -- I would say a more validated instrument than PET scan. This is going to help us. So I think those are two early sort of tweaks that we've made in this protocol to allow for easier entry into our trial. And then the last thing I'll say is, our data from the last study. The fact that we showed steroid reduction and we are the first therapy to really ever show the ability to improve symptoms and lung function while reducing steroids. This is really important to patients. So now that there's that experience from that last trial, patients are very, very interested in our therapy because we're not just showing nominal improvement in one or two endpoints. It's really all the endpoints and the one that care most about is, can I get off steroids or can this help me reduce my steroid burden. That's going to be a real attractive asset for us as we think about enrolling worldwide.

That's helpful. Thanks. And then when you just look at the especially in this current environment, it's glad to see you guys being thoughtful about your resources. So how would you describe, how much you're putting your background overall NRP to work not on the back burner but just sort of pausing a little bit from a cash spend standpoint?

Yeah. I mean, I think 2810 is something that frankly when I think about its opportunity, we've landed on these indications that this is the best fit for 2810. So moving forward, these really rare third- line cancers and especially these neuroendocrine phenotypes is really the indication where it makes most sense for 2810 to advance. Now when you think about these rare cancers, they can be slow to enroll. Certain academic centers are specialists in there -- in these sort of rare types of cancer. So it makes sense for us to partner with those academic experts And because these are rare cancers, we actually have more access to non-dilutive ways of funding because there is money out there for these sort of rare cancers. So it's an intersection of our data, number one, pointing us in that direction, but these are cancers that we should actually target with 2810. And conversely, it allows us to also work with academics, which at the end of the day serves us well under these current conditions. So it's an intersection of really I think our data, the opportunity with these experts in these rare cancers. And then the fact that given current conditions, we're grateful that we're probably going to have avenues at these centers. So I think it makes sense for us based on a lot of different factors to progress the program side by side with these centers. And conversely, of course, it does help us focus on efzofitimod, as well.

Great. Thanks for the color, Sanjay.

One moment. And our next question will come from Hartaj Singh of Oppenheimer. Your line is open.

Great. Thanks, Sanjay and team for all the updates. Sanjay, you just got a different kind of question. I think it might be a little early for this, but just first question is, we kind of -- we did a survey of high prescribing physicians for my sarcoidosis and we were -- I mean, we shouldn't have been -- we were shocked at just how much they use steroids and how much they want -- not want to use steroids, right, 90%-plus, 100% use steroids and 90% want there to patients to get off steroids or reduced steroids. So there's this burden, right? And you've talked about all the patient numbers that go into the potential efzofitimod. What about on the value side? Like, I mean, has any -- have you done preliminary work as to what could be comps for an efzofitimod towards the data? Was to recapitulate itself in Phase 3 and it was to get approved? What sort of comps are we thinking about assuming the drug that’s approved? And I just got a follow-up question. Thank you.

We have spent some time this last quarter looking a little bit more closely at that. We've done our own internal analysis actually with an external firm that has interviewed experts and done some early payer work that you might be hinting to. Our estimates were a little light and I think we're all learning that, first of all, more patients are on steroids than we expect. It's a bigger issue and patients want to get off steroids. Conversely, from a pricing standpoint, most experts have come back to us and say the pricing of this drug, if we start to see these kinds of steroid reduction effects, while also improving lung function, improving quality of life, it could be upwards to kind of what Humira is getting. That's probably on the high end, but you look at those drugs like Ofev, Esbriet. These are drugs that generate billions of dollars of revenue for Roche and BI. Our drug would I think fall into a similar pricing bucket. Look, those drugs just reduce the lung function decline. Our drug is preserving and improving lung function. It's improving symptoms, which of those drugs are not doing and it's doing so while removing steroid. So I think we're very confident now that from a pricing standpoint, we would approach some of those similar IPF drugs, which is why a lot of the modeling estimates not only internally, but also with some of you guys have been actually changing. So I do feel better again after our data that it's generating a bit more confidence that the pricing of the potential pricing of the drug could be much higher than we initially expected.

Yeah. No, that's great Sanjay. And then the other question can just have is, I was at U.S. and there's a lot of data presented by larger companies, but I was a little surprised, not in that way, but just how much buzz there was around your presentations, even though I think you had far greater presentations at ATS. What are you thinking in terms of strategic sort of a view? There seemed to be a buzz as aTyr being kind of a small cap company with a product that could play really well to a multinational company that wants to take this product out into many countries all -- many geographies all over the world. What are you thinking aside from churn in that regards? Thanks for all the questions.

Yeah. I think it's a factor of a couple of things. First, the data needs to get absorbed. I mean, we put it out at ATS. It takes a minute to kind of get worldwide. I think the publication is really going to help us and we've already seen even in the couple of days it's been up. We have new interest from other parts of the world. Pulmonologists are busy. They're managing a lot of conditions outside of the specialists. This is why I said the generalist will start to pick up on this. The other thing that's happening is we're seeing a contraction in the ILD space with a number of companies kind of moving out of the space. They're finding their therapies are not working as well in preclinical and early phase testing. You see larger companies moving out of the space. So this is why we feel like aTyr is getting that buzz that you picked up on at Barcelona that our therapy is doing things previously not seen in sarcoidosis with other therapies. And we are the furthest along. Combine that with some competition kind of going away here. We think that can help us certainly enroll. And again, we could come out of this sort of at the top of the wave here in a few years as what I think is a leading ILD company. Last thing I'll say about ERS and I think you picked up on this, interstitial lung disease is where asthma and COPD was about 15 years ago. At the ERS conference is around 2000, 2005, better new steroid sparing therapies were needed and they came out. LAMA, LABA, some of the anti-muscarinic things like that for asthma and COPD. Now the shift for respiratory experts is how do we get better drugs in ILD? You've seen United do some things with pulmonary hypertension ILD. But right now, we are kind of the leader right now for -- we certainly are for sarcoidosis, but our therapy is something that could be really useful in a number of those other conditions. This is why we think it's a multi-billion dollar opportunity. And we're hopeful to get noticed more and more in the sort of coming years as we get this data out.

Great. Thank you, Sanjay. Thanks for the questions and the updates.

One moment. Our next question will come from Edward Tenthoff of Piper Sandler. Your line is open.

Great. Thank you very much and appreciate the update. And really applaud the execution, especially on the Phase 3. Understand the focus and one of the things I've always appreciated, Sanjay, about aTyr is your close relationships with the academic labs. I think it's a really smart way to be advancing 2810. My question kind of has to do with sort of the broader utility of the platform. And are there opportunities to do partnerships with BioTechs or big pharmas around some of these other areas or is the goal really to do a lot of the early work yourselves and then do more kinds of product type deals in the future? So appreciate you taking the question. Thanks.

Yeah. I do think -- thank you, Ted, for the question. I do think the efzofitimod data has clearly validated our platform and we're seeing that through interest with really across the spectrum. Academics, other companies really digging in our Dualsystems collaboration is really about taking the lid off of our synthetases state. We think we can do it faster, better and frankly cheaper now with this collaboration. As we crank out new targets and thus far, this summer, we had a new target with fibroblast growth factor coming out of one of our synthetases targets. I think we're going to have optionality now. We're going to have the ability to say, hey, do we want to take some of these forward? We're not going to be able to take all 10 forward ourselves, let's just be honest. Not all 10 are going to be necessarily winners. That's the other thing we like to be honest here at aTyr. But I think what's going to happen here is, we're going to have an opportunity to look at these and frankly engage in potential partnerships. That's another thing I'm willing to talk too much about. But I do think that now we're at a position where we generated more interest than ever in aTyr. aTyr was very much a show me something story. We've done that. Now we have a process, now we even have a partnership with a group out of Zurich (ph) that can I think yield a number of pipeline opportunities And I would say some of these will keep kind of under our umbrella, others, we're going to have opportunities to partner. And I think that's something to expect here and prepare for in the years to come.

Great. Thanks guys.

One moment. And our next question will come from Yale Jen of Laidlaw and Company. Your line is open.

Good afternoon and thanks for taking the questions. Due to your resources sort of focusing, do you still, well conduct -- preclinical study for some new targets or whether that approach -- that department was also showing their budget as well?

Thanks, Yale. No, I think this is really related to 2810 and the clinical program. As you can imagine, moving into clinical studies, that's where it really starts to get expensive. We have a mechanism and now a process that certainly from a discovery and preclinical standpoint, there's no slowing down. In fact, you'll see acceleration in outputs. But again, we are very, very capital efficient with some of those efforts. It's really moving into the clinic where right now, absolute fit being the largest and a late phase program. We just thought it was smarter for us to really, really reiterate and focus resources there. But from a pipeline and discovery standpoint, no, these are all opportunities that we're going to still pursue. I think for 2810, we simply are taking a different strategy with that, which I think will do two things. Number one, it will put it in a home and perhaps with some academic groups that frankly will be able to move it forward at virtually little to no cost to us, so we can still advance the therapy that way. But I think the game plan right now is to generate certainly more pipeline opportunities. And then we can decide, we can see, I've always said, let's look at the data and then let's figure out, how we want to move this forward. It's an approach we've always taken. We want to be data driven. And I think from a pipeline perspective, no, there is no contraction there.

Okay, great. That's very helpful. As we talked about 2810, do you have some estimate in terms of the dollar could be saved without the clinical work over the next few years. Do you have some sort of rough estimate on that?

So I didn't -- how many dollars could be saved?

Right. Yes.

I don't think we have -- I'll let Jill also answer here. I wouldn't necessarily look at hard estimates here because one of the things is, these are rare tumor types, which I think one thing we just have to call out here, it can take much longer to enroll in these rare phenotypes. So this is another part of our strategy that who is best prepared, who has these sorts of patients and access to them. So I think from a time perspective, that's where we actually saved quite a bit. From just a rough dollar perspective, Jill, do you want to add?

Yeah. From a dollar perspective, it's not as significant. And obviously, it depends upon the trial design, which we've looked at a couple of different trial designs depending upon how we wanted approach this. But you could say on average from clinical costs maybe around $10 million or so, but it's really what Sanjay was talking about is how long that takes. So that $10 million doesn't really include all of that overhead and distraction to the company as well that could occur over that two year, two plus?

That's right. Yeah. Early phase clinical oncology trials can sometimes take -- there's a number of hurdles to move through. It's also a rare phenotype. But roughly speaking, I think $10 million for a program like that is a comp that most companies would look at there. The distraction part is, I wouldn't necessarily say that we're able to do a lot of things here at aTyr, but I think this is the best thing for us. And frankly, putting it in the hands of folks who maybe have these patients with neuroendocrine phenotype, they're quite excited to move the asset forward there. And it also comes with the benefit that we may be able to tap into funding because we are focusing on these more rare and ultra-aggressive tumor types.

Okay. Great. And maybe the last question here is that in terms of the clinical study in Japan, do you -- are you guys going to reveal in terms of probably the size and maybe any other colors of that part of the trial? Thanks.

I would say, roughly speaking, a region like Japan, regulators typically like to see at least from a global trial, at least about 10% of the patients come from that region. An indication, a rare disease like this, partners our piggybacking off of our global data. So it's obviously difficult to enroll and power a trial in a specific region like Japan. But I would anticipate right now early on somewhere around 10% of our patients will need to come from Japan somewhere around that range.

Okay, great. Thanks. Appreciate that and congrats on some good decision made so far.

Thank you.

One moment. Our next question will be from Sean Kim of Jones Trading. Your line is open.

Yeah. Hi. Thank you for taking my questions. And I apologize if I'm repeating questions that have been asked previously, but for the Phase 3 efzofitimod trial, can you kind of remind me what the statistical plan has been including the statistical powering? Also, how much of a separation from placebo has been baked into that kind of calculation?

Sure. Happy to do that. So our trial is powered. We have 264 patients, 3 dose arms, there's a 5 milligram, a 3 milligram and a placebo arm, and each arm is 88 patients. We powered this trial over 90% -- 92% to be exact for either the 3 milligram or the 5 milligram dose of showing statistical superiority to placebo. So we have essentially two shots on goal with either of these two at a much higher clip typically you want to power these studies at least 80%. We've actually done them both -- with both of these doses at over 90%. In layman's terms, what are we trying to show in steroid reduction, an absolute reduction of somewhere between 2.5 milligrams to 3 milligrams difference is, in our eyes meaningful. In the eyes of experts, for example, if you have a patient coming in at 10 milligrams and getting on EFZO, gets them down to 7.5 that's meaningful benefit. It may not seem like a lot for us, but every day, we're moving 2 milligrams to 3 milligrams of prednisone, this adds up. Removing that decreases the overall cumulative burden and over the course of six, nine, 12 months, this is going to help you with cardiovascular, metabolic, neuro effects of what steroids do. So hope that provides a little bit of color there. Very, very well powered. I'm a little bit very particular about statistics having a background in that. So I think that's something that we wanted to overpower if you will and we have two shots on goal to essentially show about that 2.5 milligram and 3 milligram difference.

Okay. That's very helpful. Thank you. And I guess just one follow-up question on that is, you have three arms with 3 mg and 5 mg and placebo. Just curious what’s the rationale behind going after two different doses versus just going after higher dose that might provide improved efficacy and maybe increased [indiscernible]?

Yeah. So this was actually an initial approach in dialogue we had at the end of Phase 2 meeting because our last data set showed that 5 was rather outstanding, but even the agency pointed out that [indiscernible] 3 milligram are actually quite good. We showed improvement in symptoms. We showed lung function improvement and we showed a reduction of about 49% in the 3 milligram arm. The view was it would be good to also interrogate that dose because it provides a backup to, if 5 milligram, for example, we see any emerging toxicity. Now we haven't seen any toxicity with any of our high doses -- any of our doses from the last trial. But let's also understand that, that data set had less than 10 patients in arm. Now we're getting up to close to 90 patients in arm. So there is a possibility of course that safety at any time might emerge as you start to look at more and more patients. By having the 3 milligram dose, it also derisks any potential safety -- emerging safety signal that might exist. And this has occurred -- I've had this occur in another program at previous company other than where we -- the backup dose, it was good that we actually had it in there because there were some tolerability issues and it allowed the lower dose to get approved. So this was something actually at the behest of the agency. I actually thought it was a good idea. It's the reason why our numbers have bumped up. Previously, I was telling investors with one dose and one placebo the trial could probably be adequately powered at somewhere around 220, 230 patients when you add this additional arm and you still want to be over 90% this is how we get closer to 264. So I think it's a combination of de-risking for a potential effect that may or may not emerge. We don't think it will. And it gives us another shot on goal.

Okay. Thank you. And how about the timing and the sequence of different events. So from clinicaltrials.gov information, it looks like the trial is scheduled or expected to complete in May ‘24, early ‘25. So is that the kind of ballpark timing that I should be kind of expecting the study to complete? And also related to that is, for the other programs in [indiscernible]. Would you be expecting that to complete the EFZO-FIT trial and see the outcome before kind of embarking on Phase 2 for the other programs or the three programs be a sequence somewhere in between as far as timeline goes? Thank you.

But at this point, I'll answer the second part first. At this point, we're focused on this one indication. So while we have some encouraging signals with additional ILD indications, right now, we're focused on this trial and focused on getting it done. When you look at clinicaltrials.gov, we have to put down something. This is our best early estimate. But as we get into enrollment, I'll be able to look at that and say, does that timing still make sense? Should it be pulled in? Should it go out further? This will be predicated on how we do here really over the next six months. But most sponsors have to put something an early estimate. And I think we have that for something like January 2025 right now.

Okay. Thank you. And I guess my last question is about the cash runway. I haven't seen the guided number on the press release, but I just want to make sure if I'm not missing anything. Have you guided the cash runway and also now that you are not pursuing 2810 development, how much of additional kind of expansion that we cannot expect from, in terms of cash runway from kind of not working on 2810?

Yes. This is Jill. We don't typically give a cash runway because we look at it by projects. And like we said during the script, we do have financial and strategic plans to be able to get through the data readout for EFZO-FIT. So that's using our current cash will be getting milestones from Kyorin and then also use of the current equity vehicles that we have out there right now. We're saving some money from not doing 2810 in the clinic like we just discussed with, Yale. Those types of trials just generally typically or maybe around $10 million-ish, but it's more -- that's just the cost of the trial. It's more the time that those take and the overhead that is needed just to continue running those over a period of two or less longer years.

And I'll just reiterate, we're still retaining that value for 2810. So any IP that's the other reason, we talked a little bit about. We had some patent language in this script. We're still retaining that value of any data that's also coming out of these potential collaborations. So I think it's a really smart way for us to move things forward in the hands of experts, spend less cash ourselves, but still retain that upside should we see signals in those neuroendocrine phenotypes.

Okay. Very helpful. Thank you very much.

One moment. And our last question will come from Kumar Raja of Roth. Your line is open.

Thanks for taking my questions. So with regard to the clinical trial side from the Phase 2 trial, what are you seeing in terms of those sites coming onboard in the Phase 3 trial? And also you talked a little bit about the side effect profile. So what are your expectations in terms of the dropout rate here in the Phase 3 trials? Thank you.

So the trials -- thanks Kumar for the question. For the trials sites that were previously involved, we are seeing obviously good uptake initiation, many of these were all centers in the U.S. and those that were involved previously obviously are very, very excited about participating in the next trial. If you look at our CHEST publication, you can look at each of those investigators on that publication. All of those sites are going to be what I would consider our lead sites. And some of these are bulky academic institutions, but even some of the timelines of approval has been rather quick in my estimation on how quickly we're moving things forward. That's because we have good data. That's because we have the data that we can talk about. And those local ethics and IRB committees, I think our team is doing a really, really good job, but I also have to tip my hat to those institutions that they are also responding quickly because they want to get patients into this trial. And I know many of these centers are also prioritizing our study over even any other sarcoidosis smaller trials that are out there, early phase trials. They realize a late phase trial like this is really, really important. So I think that's key. You also asked the question about dropout. With 264, the estimation we have here and what we built into the power calculations is seven to eight patients per arm if we have that kind of cushion. So I want to be at 240 patients. So the worst case scenario here is 24 patients or so, eight per arm and then that would actually not impact the power calculations as long as we stay within that. And other than reasons outside of our control, sometimes there's some operational reasons. We do not expect anyone necessarily to need to drop out, to go back to say standard of care because that's written into our protocol. So folks are not doing well, they can go back up on their steroids. In fact, we want that to happen because we think that's going to happen at a much, much more greater rate in the placebo population. So nonetheless, we still have a cushion as I said, seven to eight patients per arm for dropouts.

Very helpful. Thank you so much.

Sure.

And I'm showing no further questions. I would now like to hand the call to Sanjay for closing remarks.

Well, I want to thank everybody. Great questions today. Lots of questions. We appreciate it. Really staying obviously laser focused here on the EFZO-FIT trial. Appreciate a lot of updates today, some strategic decisions that we've made. Look forward to interacting in the near future and we really thank everyone's support listing on the line here our investors. Thank you so much.

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