aTyr Pharma Inc (ATYR) 2020 Q3 法說會逐字稿

Good afternoon, ladies and gentlemen and welcome to the aTyr Pharma Third Quarter 2020 Conference Call. (Operator Instructions) As a reminder, this conference is being recorded for replay purposes.

It is now my pleasure to hand the conference 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 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 programs in neuropilin-2 or NRP2 and tRNA synthetase biology. Jill will 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 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 2020 results conference call. As we begin with our third quarter 2020 update, I would like to take a moment to acknowledge all the hard work and dedication from the aTyr team, our investigators, partners, collaborators and patients who have risen to the challenge of learning to operate under the unique circumstances that we have all experienced this year due to the COVID-19 global pandemic. With everyone's support and cooperation, we believe we are having an incredibly productive year even amidst the pandemic.

Now let's get started with our quarterly review and corporate update. During the third quarter of 2020 and subsequent period, aTyr remained focused on our clinical program for our lead therapeutic candidate, ATYR1923. We now have 3 active clinical trials as part of this program. Most notably, we have completed enrollment in our Phase II trial in COVID-19 patients with severe respiratory complications, and we expect to report top line data from this study around the turn of the calendar year. Our trial in patients with pulmonary sarcoidosis and our partner Kyorin's trial in healthy volunteers in Japan both continue to enroll. In addition, we achieved key milestones in our research and discovery programs, where today, I am proud to announce that we have selected our lead candidate from our NRP2 antibody program in oncology. As we begin, I will summarize additional key highlights from the third quarter and subsequent period.

We entered into a research collaboration with the Medical University of South Carolina, or MUSC, and principal investigator, Dr. Robert Gemmill to support our NRP2 antibody program in oncology. We discovered new receptor targets for 2 tRNA synthetases from our pipeline as part of our research collaboration with CSL Behring. The receptor targets may have utility in the development of new therapeutic approaches for cancer and fibrosis. And finally, we published a paper in the peer-reviewed journal mAbs, which highlighted the novel technological advances pioneered by our research team to isolate, characterize and engineer high affinity therapeutic antibodies.

We've made significant headway with our clinical and research programs, with steady and consistent progress throughout 2020 amidst the challenges presented by the pandemic. And we fully expect this momentum to continue through the fourth quarter. Today, I will provide an update on our clinical program with our lead therapeutic candidate 1923 for each of our 3 trials. I will also comment on our ongoing preclinical research and development efforts for our programs in NRP2 and tRNA synthetase vitality. Jill will conclude with a review of our financial position.

Let's begin with our Phase II trial of 1923 in COVID-19 patients, which recently completed enrollment. Many COVID-19 patients with severe disease experience a form of interstitial pneumonia, caused by an excessive inflammatory response in the lung, which can lead to serious and sometimes fatal respiratory complications. These patients are more likely to be hospitalized, require supplemental oxygen, need mechanical ventilation and spend time in the ICU. They may also experience longer hospital stays and permanent injury to their lungs. While we are encouraged by the progress in the development of vaccines and standard of care has improved, we believe there will continue to be a need for new and effective therapies to treat the symptoms of patients hospitalized with severe cases of COVID-19.

1923 is a potential first-in-class immunomodulator that downregulates cavern immune responses in inflammatory disease states. 1923 has been shown preclinically to downregulate T cell responses, thereby dampening the inflammatory cytokine and chemokine signaling, both of which have been implicated in these severe COVID-19 cases. Further, NRP2 is upregulated on key immune cells known to play a role in inflammation. And as we have learned, this includes lung tissue in patients who have died from COVID-19-related severe respiratory failure. We believe 1923 binds selectively to NRP2 to normalize the immune system, serving to resolve inflammation and prevent progressive fibrosis, thereby stabilizing lung function and alleviating morbidity and mortality.

Data from 1923 in animal models of the new mediated acute lung injury demonstrate that 1923 is more effective if given earlier in disease progression. Further, 1923 downregulated T cells, serving to do more than just act on one individual cytokine. We believe that by administering 1923 earlier in the excessive inflammatory response in COVID-19, notably before patients require mechanical ventilation, 1923 may be able to dampen the immune response and improve patient outcomes.

Based on the strong scientific rationale with 1923's mechanism of action and overlapping disease pathology, we worked very closely with the FDA to initiate a Phase II randomized, double-blind, placebo-controlled study in hospitalized COVID-19 positive patients with severe respiratory complications, who do not require mechanical ventilation. Patients enrolled in the trial were randomized 1:1:1, to a single intravenous dose of either 1 or 3 milligrams of 1923 or placebo and are followed for 60 days post treatment. The trial is designed to evaluate the safety and preliminary efficacy of 1923 as compared to placebo through the assessment of key clinical outcome measures.

An independent data and safety monitoring board, or DSMB, conducted a preplanned blinded interim safety analysis after the first 5 patients were dosed. The study drug, 1923 or placebo, was observed to be generally safe and well tolerated with no drug-related serious adverse effects. And the DSMB recommended the trial continue unmodified. These findings are consistent with previous safety assessments of 1923, including a Phase I study in healthy volunteers and blinded DSMB reviews in our ongoing Phase Ib/IIa trial in pulmonary sarcoidosis patients, including reviews of cohorts testing the very same doses being tested in the COVID-19 study.

Last month, we announced that we completed enrollment in this study. The trial enrolled a total of 32 patients at hospitals in the U.S. and Puerto Rico, exceeding the target enrollment of 30 patients. We expect to report top line data from this study right around the turn of the calendar year. The top line data will include data on safety, including adverse events and some of the key clinical outcome measures for all patients enrolled in the trial.

In particular, we will focus on time to recovery and proportion of patients achieving recovery as well as clinical improvement as assessed by change from baseline in the WHO ordinal scale. These clinical outcome measures are in line with those being prioritized by the FDA and similar to those reported by other trials investigating new therapies for this patient population, including some that have been approved or granted emergency use authorization.

We're very pleased to have completed enrollment in this study. We believe 1923 holds great promise as a potential therapy to treat respiratory complications that result from COVID-19. 1923 is not a repurpose therapy. It has been rigorously designed and developed to target aberrant immune responses in the lung. It has an existing and growing safety database and the disease pathology of COVID-19 continues to unfold as one with increasing overlap with 1923's mechanism of action. Our approach to initiating and conducting this trial has been thoroughly evidence-based, and we are now focused on reporting the data in a manner with the highest degree of integrity. By doing so, we aim to provide for the optimal outcome and potential next steps for the program. We're very eager to share the top line results very soon.

Now let's discuss our Phase Ib/IIa trial of 1923 in patients with pulmonary sarcoidosis, which is currently enrolling. Pulmonary sarcoidosis is a major form of ILD and is characterized by the formation of granulomas or clumps of immune cells in the lungs. If left untreated, it can lead to irreversible scarring and diminished lung function. Current treatments are limited and often include treating the inflammation with corticosteroids and other immunosuppressive therapies, which have limited efficacy and serious long-term toxicity. Additionally, many patients do not respond to this current standard of care. There remains a need for a novel therapeutic option for patients with progressive disease with a better efficacy and side effect profile.

As a reminder, this Phase Ib/IIa trial is a randomized, double-blind, placebo-controlled multiple ascending dose clinical trial in 36 pulmonary sarcoidosis patients. The trial consists of 3 cohorts testing doses of 1, 3 and 5 milligrams per kilogram of 1923 or placebo, dosed intravenously every month for 6 months. The primary objective of the study is to evaluate the safety and tolerability of multiple ascending doses of 1923. Secondary objectives include assessment of the potential steroid sparing effects of 1923, in addition to other exploratory assessments of efficacy, such as lung imaging, lung function assessed by pulmonary function tests and relevant serum biomarkers.

Throughout the course of the trial, an independent DSMB conducted 2 safety reviews, both of which had positive outcomes and permitted progression to recruit the third and final cohort of the study, which we are enrolling -- which we were enrolling at the start of the year when the pandemic emerged. At that point, some, but not all, of our investigational sites had to pause enrollment.

We've learned a lot throughout the year as it pertains to navigating patient enrollment and conducting clinical trials in this environment, including with this high risk patient population. We've worked with each site and patient to adapt to the challenges that presented in order to ensure patient and provider safety, while maintaining the integrity of the trial. When needed, we allowed for the use of alternate medical safety assessments such as phone contact and the use of local labs, for example, for spirometry testing.

These adjustments were within the FDA guidelines on conducting clinical trials during the COVID-19 public health emergency. And we believe they've been instrumental in permitting the trial to proceed. In August, we announced that the majority of our sites that were paused had resumed clinical trial activities. These sites continue to screen and dose patients, including in geographic areas, that have experienced a recent increase in COVID-19. We plan to provide an update on the expected timing of the results once the trial has fully completed enrollment.

We'll finish the discussion of our clinical program for 1923 with a few comments on our third trial, a Phase I study currently enrolling by our partner Kyorin in Japan. Earlier this year, we entered into a collaboration and license agreement with Kyorin for the development and commercialization of 1923 for ILDs in Japan. In order to conduct clinical trials with a new therapeutic drug candidate in ILD patients, Kyorin is required by the Japanese regulator, the Pharmaceuticals and Medical Device Agency, to investigate safety and pharmacokinetics in the Japanese population. This requirement remains despite the existing data for 1923 from trials conducted in the U.S. and Australia.

In September, Kyorin dosed the first subjects in this trial, which is a Phase I placebo-controlled study to evaluate the safety, pharmacokinetics and immunogenicity of 1923, known as KRP-R120 in Japan, in 32 healthy male Japanese volunteers. This trial is currently enrolling and has not experienced any delay as a result of the pandemic. We look forward to the results, which upon successful completion, will permit Kyorin to initiate patient trials for ILDs in Japan.

Now let's turn to our research pipeline, starting with our NRP2 antibody program, which we believe has great potential to produce future value-driving candidates. As a reminder, NRP2 is a compelling therapeutic target in the areas of oncology and inflammation. In cancer, NRP2 is upregulated on a variety of different solid tumors. High NRP2 expression is linked to worsened patient outcomes in many cancers and may contribute to drug resistance with current therapies. Antibodies that can selectively block different NRP2 signaling pathways may have therapeutic potential.

So aTyr has developed a panel of fully humanized monoclonal antibodies to selectively target distinct domains of NRP2 for diverse therapeutic applications. Today, we are proud to announce our lead investigational new drug, or IND candidate from this panel, ATYR2810. 2810 specifically and functionally blocks the interaction between NRP2 and one of its primary ligands, VEGF. The role of NRP2 and VEGF signaling in the tumor microenvironment and it's importance in the progression of certain aggressive cancers is becoming increasingly validated.

Earlier this year, we presented preclinical data at the American Association for Cancer Research Virtual Annual Meeting from a collaboration with Dr. Arthur Mercurio, one of our key scientific advisers and his lab at the University of Massachusetts Medical School. This data showed that 2810 demonstrated tumor inhibitory effects and increased sensitivity to chemotherapy in human-derived organoids and other in-vitro models of triple-negative breast cancer, an extremely aggressive cancer where NRP2 has been shown to be highly expressed and many patients are not responsive to currently available treatments.

These findings suggest that targeting NRP2 and the VEGF pathway may be an effective therapeutic strategy for breast cancer, and potentially other aggressive solid tumors. Based on this and additional data we have generated, internally, over the past several months in various tumor models, we will be targeting 2810 for therapeutic application in cancer with IND-enabling activities starting immediately.

In addition to advancing 2810 in cancer, we continue to explore and optimize the capabilities of our antibody engineering platform by leveraging both our internal expertise and external collaborators. Dr. Robert Gemmill, Professor of Medicine Emeritus in the Division of Hematology/Oncology at MUSC will serve as a principal investigator for the collaboration, which is focused on evaluating antibodies that selectively target specific NRP2 isoforms for potential use in the treatment of lung cancer, where NRP2 is also (inaudible).

Lung cancer is the most common cancer globally and the leading cause of cancer death. Despite currently available treatments, many tumors become metastatic or develop resistance to targeted therapies. The development of new therapeutic strategies, which may offer alternative mechanisms to existing therapeutic approaches and reduce drug resistance are greatly needed. Dr. Gemmill is a noted expert in the field of NRP2 biology and its role in cancer. His research focuses on the alteration of genes during lung and kidney cancer development. We look forward to collaborating in this area of research with Dr. Gemmill.

Our NRP2 antibody program is a product of the state-of-the-art antibody discovery platform that aTyr scientists have developed. This work was recently recognized through the publication of a peer-reviewed article in the journal mAbs. This article highlights novel technological advances pioneered by our research team to isolate, characterize and engineer high affinity therapeutic antibodies. Our team continues to deploy these and other cutting-edge antibody discovery techniques to generate future pipeline opportunities. This research was conducted in collaboration with AbCellera Biologics, a leader in antibody technology and drug discovery platforms. We served as co-author of the publication.

Finally, I will finish with an update on our tRNA synthetase discovery program. Through our research collaboration with CSL Behring, a leading global biotherapeutics company, we have discovered new receptor targets for 2 tRNA synthetases from our pipeline. Identifying target receptors for an extracellular tRNA synthetase helps inform our discovery and development activities by providing additional focus towards relevant disease pathways and potential therapeutic applications. These new receptor targets that we identified may have utility in the development of new therapeutics to treat not only cancer, but also fibrosis. We expect to present findings from this research at a scientific conference in the very near future. We continue to analyze the data from these intriguing findings and are in discussion to map out next steps in collaboration with our partner, CSL.

Overall, we're very pleased with the progress we've made to date in 2020. We have momentum with our 3 active clinical trials for 1923. We initiated and completed enrollment in our COVID-19 trial, and we expect to report top line data from this trial very soon. We continue to enroll patients in the third and final cohort of our trial in patients with pulmonary sarcoidosis. And our partner, Kyorin, is enrolling its initial study in Japan. Today, we declared the first IND candidate from our NRP2 antibody program, ATYR2810 for oncology. And additionally, we have discovered new receptor targets for 2 tRNA synthetases from our pipeline.

When we look at our progress this year compared to where we were a year ago, we're highly encouraged. We now have 3 clinical trials, a preclinical program that's advanced a new IND candidate, and 2 tRNA synthetase discovery initiatives that have advanced. As we make our way through the final quarter of the year, we're excited by our progress and the potential that our clinical programs and pipeline hold.

With that, I'd like to turn it over to our Chief Financial Officer, Jill Broadfoot, to review our financial results.

Thank you, Sanjay. Net loss for the 3 and 9 months ended September 30, 2020 was $6.6 million and $11.3 million, respectively compared to $5.6 million and $17.6 million for the same period in 2019, respectively. While the third quarter net loss was slightly higher than prior year due to increased clinical activities, the decrease in net loss for the year was due primarily to $8 million from license revenue received under the Kyorin agreement. Under this agreement, we are eligible to receive payments upon achievement of certain development, regulatory and sales milestones. We expect to see the first of these milestone payments beginning in 2021.

We ended the third quarter with $36.1 million in cash, cash equivalents and investments, and we continue to expect to end the year with more than $20 million in cash, consistent with prior guidance. Also, as of September 30, 2020, we have $3.1 million of term loans. However, on November 3, we fully repaid our term loans and retired our debt. We are happy to report that we no longer have any debt on our balance sheet. By paying off this debt, we are eliminating $8 million per year in principal and interest payment. To note, 2020, actually included close to $10 million in debt payments, which we will not have in 2021.

We are very pleased with what we have been able to accomplish while upholding the responsibility of the $20 million of debt that was secured back in 2016. We expect to have the opportunity for a highly effective management of our cash burn in 2021 and beyond. Now I'd like to turn the call back over to Sanjay before we open it up to Q&A.

Thank you, Jill. We appreciate everyone's interest and continued support and look forward to providing updates in the very near future. At this time, Jill and I will be happy to take your questions.

(Operator Instructions) Your first question comes from the line of Hartaj Singh with Oppenheimer.

Great. Just a couple of questions. One is focused on ATYR1923 and COVID-19, your trial there. Sanjay, when I'm looking at the -- your primary and secondary endpoints on control (inaudible), you've got some -- a few of them that are 60 days, some of them are day 14 of discharge. I know you're going to report results of this (inaudible) trial 60 days, I guess, roughly after last patient was enrolled. But how to think about some of those endpoints that are shorter? Is there a potential for an update if the results are better than expected sooner than that? Or really, it's just you got to wait for that 60-day period after the last patient visit to read it out? And I just got a couple of follow-ups.

Yes. Hartaj, we actually are going to be prioritizing, I would say, the first 30 days of endpoints. So when we look to cut this data based on where we saw the sort of enrollment curve, we feel pretty good about being able to read out really most of what's occurred in the first month of the trial. We could certainly look at cutting things at different time points. But based on the trajectory of how patients enrolled and how they basically did this trial, we're going to have a nice data set, I would say, prioritizing that first month.

It's that last 60-day visit where we wouldn't necessarily have a full data set. But that 60-day visit is largely safety when -- safety in its nature as a safety follow-up. So we feel pretty good about being able to have a complete message really by looking at those data past that first month, which is, I think, in line with most other companies on what they're presenting.

Great. And then just a question on the pulmonary sarcoidosis trial. I know you're restarting the third cohort with a readout sometime the first half next year. But has there been any changes -- because you have to pause enrollment and some of those patients might or might not have gotten a dose or missed a dose. In terms of your protocol, will anything change in the analysis plan for the pulmonary sarcoidosis trial when you read out? And I got another couple after that.

Yes, we're not making changes to the statistical analysis plan. As I said, there sometimes can be some operational things that our team is allowing within the protocol individuals to enroll and be managed and followed in the trial. We've learned quite a bit about how to jump through those hoops right now, working with different centers, all the while keeping patients enrolled in our trial and trying to minimize any kind of missed visits, missed dosing, things of that nature.

So I can tell you that since we've restarted, we've done a really good job of sticking to good operating guidance, practice integrity in our trial. And I also think that we've been able to successfully serially dose these patients. And I think that's really a job that our clinical operations team has done a really great job here on navigating this kind of different environment we're in, so that we minimize the things that you point out. We don't want any of that to happen. And we think we've done a great job there.

Yes. And Sanjay, will this sort of second kind of surge of infections and hospitalizations -- your pulmonary sarcoidosis patients have -- these are issues with the lung. Could there be any change in the trajectory of the third cohort enrollment with this kind of surge going on right now?

We do not anticipate that. I think that has -- there's a couple of reasons for that. Number one, we've been able to figure out basically how to keep these patients safe, manage through the trial. And we have evidence of individuals being able to dose through and meet all of their -- more or less all their commitments in this trial safely. So by doing that at 1 or 2 sites, the remainder of our sites have seen that. And now we have a really nice ability to operationalize that across all our studies, even though some of them right now are going through a cresting of cases locally.

So I think we've implemented some real time feedback. As I said, it hasn't impacted our statistical analysis plan. It just involved us to be a little bit more nimble on some operating elements. And we do not expect even at the current rate of COVID cases flaring all over the country, it is not slowing things down for us, and we don't anticipate it will.

Yes. And then just on the ATYR2810. You had mentioned breast cancer is possibly the first area you could go in with your IND. Would these be sort of -- what types of breast cancer patients would be -- the hormone sensitive? Or any thoughts there? Or it's still too early in terms of where you are in the IND filing process?

I think we had obviously, some really nice data that we presented at AACR in triple-negative breast cancer. So this is a subcohort, a more aggressive cohort of breast cancer patients. So I think that's something that we definitely want to follow up on. With our new collaboration with Dr. Gemmill, we see entrants into lung cancer and potentially kidney cancer. But as part of our IND-enabling work, part of this is focusing in on which tumor types does 2810 show the best amount of early efficacy.

So I will tell you that now (inaudible) antibody, we can now focus in on where we think it will be most effective. That's -- those are some clues on some early tumor environments that we're looking at a little bit more intensely, triple-negative breast cancer, also lung cancer and also looking a little bit at renal cell carcinoma as well.

Okay. And then do you expect to file that IND sometime in 2021? Or are you -- or is it -- when can we get some visibility on just when the filing would happen?

We think we can file or at least get prepared to file right towards year-end next year. I think we've advanced our knowledge that it's not going to take us 18 or 24 months. We're looking at more like a 1-year time frame here. So a little bit early to provide guidance in the exact IND filing date, but we think that based on the data we see, if we continue to track and see similar kinds of efficacy signals throughout the course of the first half of 2021, I think we'll be in good shape towards the tail end of '20 to potentially file an IND or even do so right away at the beginning of 2022.

Yes. That makes sense. And my last question is to Jill, it's just on cash burn for next year. Assuming if your COVID-19 trials sort of end towards the latter part of this year, you don't have those interest payments next year, how do we think about just cash burn? I know that we're actually only a few months away from the fourth quarter call, JPMorgan, et cetera. But just how to think about cash burn for next year from an OpEx perspective, Jill?

Hartaj, that's a good question because there are potentially going to be a lot of changes next year in our operations compared to this year. Next year, we could potentially be getting ready for a registrational trial for pulmonary sarcoidosis. We might be gearing up for COVID, which would require additional manufacturing. So we're actually looking at each of those activities and obviously, we're in our budgeting process right now. So it is too soon to give guidance. But I do think that given success and planning for success with these trials, we should be spending more on ramping up those clinical trial activities and/or manufacturing.

Your next question comes from the line of Joe Pantginis with H.C. Wainwright.

I wanted to focus on -- my question is really focusing on the speculative realm here. So assuming that the COVID study turns out positive, and Jill just sort of touched upon this as well with her comment, based on your wish list and based on regulatory feedback, what do you consider as next steps regard to study-wise? When could you potentially look towards an EUA? And what do you have in place currently for manufacturing purposes? And what do you envision needing?

Yes. Joe, great questions. I think with good data, a lot of good things can happen with regards to, first off, accelerating into the next trial. We had to provide a manufacturing plan and the ability to move into that trial rather quickly when we first met with the FDA. So we do have drug product available to quickly move into the trial if we choose to do so, number one.

Number two, getting feedback, I think, and the potential for emergency use authorization. I think you've seen a lot of therapies out there even with modest effects generate authorizations, even improving hospital stay by 1 day is viewed as a game changer in the current environment as we're in crisis mode. So we do think that if we can show benefit here because we've run a placebo -- a rigorous placebo-controlled trial under the guides of the FDA and we focused on the very same endpoints that have garnered these sorts of authorizations, we feel pretty good about the regulatory climate to move forward.

Accessing other forms of grants, things of that nature, you see a lot of companies being able to also accelerate those discussions. We would expect to need to do some of that when we start to think about the commercial supply of 1923 targeted to COVID-19. So while we're game ready for the next trial, if we have good data, I would expect that we would rapidly advance discussions with the government. And there, you have seen quite an openness to accelerate manufacturing for small and large companies, assisting with that. And we're ready for that, and we would expect that if we have good data.

Your next question comes from the line of Zee Jallah with ROTH Capital Partner.

Congrats on the update. I was really happy to see that you've now selected an IND candidate or a preclinical candidate for your new COVID antibody 2810. And so really excited to see that. I think we can officially call you a autoimmune and oncology company now.

Also, Sanjay, I think I heard you say that lot of the IND-enabling studies are underway or about to begin immediately. So happy to see that as well. But I think one of the things you also discussed early on is that you're kind of like the leader in the neuropilin space right now. So do you plan to do an event or something like that with KOLs to also kind of educate, not only investors, but the clinical community because I think that will be really important in terms of eventually initiating clinical studies and getting some support for that.

Yes. Thanks, Zegbeh. Absolutely. I think as we are the leader in neuropilin biology now, and we have also got our arms around a significant expertise both internally with how we manufacture these antibodies and really are getting recognized now around how efficient and from an affinity point of view, we really are producing good technology here. And then externally, being able to work with the best and brightest, who have decades of experience in neuropilin research, people like Dr. Mercurio, Dr. Gemmill, absolutely.

As we start to generate data and show activity in more of our tumor experiments, these are things that -- we like to be transparent, we like to publish, we like to put in abstracts. We like to get out there at medical conferences. And then once we have a repository of good data there, absolutely, I think it makes sense to pull together the investor community and really outline all of the things we've seen. We're building this program very much in the manner that we systematically and carefully built our 1923 program.

And then another one I had, another pipeline development. I was really glad to see the recent announcement on your update in terms of target identification with your tRNA synthetase platform in cooperation with CSL. I think a lot of people see the platform. They know you have the partnership, but we hadn't heard much news. So it's really nice to see that -- some of that effort is now paying off. How else can we see some of the benefits of that? When is it perhaps going to end up in preclinical studies or additional preclinical studies? And then anything after that.

Right. So as you can imagine, these are pretty exciting insights. Years ago, we discovered 1923 binds neuropilin-2 and that really launched multiple programs from that. With these results, these findings, of course, we're working closely with our partner around next steps. But we also want to get this data out in a scientific conference. We think they're meaningful, it's important. It's going to transform a whole, another pipeline opportunity for us. We want to do that in a rigorous scientific setting. That's when you'll get to know what these receptors are. As I said, some really nice signals there that can point us in other directions in cancer and other areas in fibrosis. Both things, I think, stay tuned. We'd like to debut this in more of a scientific setting. But it was important for us to get this out as we had committed to giving an update on where we were with the CSL collaboration.

And as you talk about that, actually, I was just talking about educating people in NRP2, but it sounds like with this pipeline development, you could actually have a full R&D day. So looking forward to seeing what you guys do with some of this work. But I think a lot of folks are interested in the near-term clinical data that's coming up. So just clarification, I think, on a question that Hartaj asked, so for the readout that's coming up for the COVID-19 program or study with 1923, are we looking at 30-day data? Are we going to get anything less or more than that?

Yes. I think you would -- we'd prioritize those clinical endpoints. We're going to be looking at -- we're going to be able to take it out to about 30 days. We should have complete data set for all of our patients at that point, from not only an activity standpoint, but also a safety standpoint. And then the only thing really remaining would be some of our bio-analytical work, some of the cytokine, that stuff will come in later with the 60-day safety data, and that would be an update.

But I think at this top line result, we'll be able to pull together really all of these patients and how they've done in the critical period, which is -- I really think is in that first 2 to 4 weeks of being hospitalized. So this is something that I said we'll be looking at right at the turn of the calendar year. The exact date is still pending, but we're looking at that time frame, feel pretty confident we're going to land right there.

And then just a final one here, and I don't think you have an answer for this one just yet, but for the pulmonary sarcoidosis study, it sounds like things are progressing. Are you at the stage now where you can provide more granular details or a time line as to when we can see the data from that? Or you'll provide that at a later time point?

Not quite yet. I'm close, but stay tuned. We -- what I want to be able to do is once we effectively dose that 36th patient, and I know exactly when that is confirmed, I'll be able to then highlight exactly when -- what day next year, then we'll have -- what quarter next year we'll expect data. So that update will be coming once we dose that 36th patient.

And there are no further questions at this time. I will now hand the conference back over to Mr. Sanjay Shukla.

Well, thank you, everyone, for your time listening to our progress, and we look forward to being in touch in the very near future. Everyone stay safe, be well. Thank you.