Earnings Labs

aTyr Pharma, Inc. (ATYR)

Q3 2019 Earnings Call· Thu, Nov 14, 2019

$0.79

+0.22%

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Transcript

Operator

Operator

Greetings, ladies and gentlemen, and welcome to today's Third Quarter 2019 Earnings Conference Call. At this time, all participants are in a listen-only mode. A question-and-answer session will follow the formal presentation. [Operator Instructions] It is now my pleasure to introduce your host, Ms. Jill Broadfoot. Thank you, you may begin.

Jill Broadfoot

Analyst

Thank you, and good afternoon, everyone. Thank you for joining us today to discuss aTyr's third quarter 2019 operating results and corporate update. We are joined today by Dr. Sanjay Shukla, our President and CEO. On the call, Sanjay will provide an update on our corporate strategy including the clinical development of ATYR1923 and our recent research collaboration announcement with Boston Children's Hospital. I will then review the financial results and our current financial position, before handing it back to Sanjay to open the call up for the 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 on the Company's press release issued this morning 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 and 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.

Sanjay Shukla

Analyst

Thank you, Jill. Good afternoon everyone and thank you for joining us for our third quarter results conference call. During the third quarter, we continue to make positive strides towards developing novel therapeutic candidates for patients, with high unmet medical needs by using analogy of the extracellular functionality and signaling pathway of tRNA synthetases. Today, I will update you on our progress with our lead therapeutic candidate ATYR1923 and advancement in our neuropilin-2 or NRP-2 biology research and development efforts. Jill will continue with the review of our financial position. 1923 is an engineered long-acting protein that is derived from the HARS gene. We are exploring the use of 1923 across a series of inflammatory diseases in the lung, which are known as interstitial lung diseases of ILD. Our initial ILD indication is pulmonary sarcoidosis, one of the more inflammatory forms of ILD. Pulmonary sarcoidosis is characterized by the granulomatous inflammation in the lung that is left untreated can lead to irreversible scarring and diminished lung function. As we look to build upon the significant body of 1923 translational data in the animal efficacy model, we've recently began characterizing expression of NRP-2 in human tissue samples. We obtained tissue samples from a biobank of sarcoidosis patient, not in our study in order to evaluate NRP-2 expression in target tissue, and we have observed some rather strike finding. We've confirmed positive expression of NRP-2 localized within the granulomatous tissue from these patients in both lung and skin granulomas. These are results quite impactful as they confirm that NRP-2 the target receptor for 1923 is expressed in the essential pathologic issue from sarcoidosis patient. We planned to present this data at a medical conference in the near future and these important findings considerably strengthened our hypothesis that 1923 we'll have clinical activity…

Jill Broadfoot

Analyst

Thank you, Sanjay. For the three and nine months ended September 30, 2019, we recognized collaboration revenue of $184,000 and $278,000 respectively. These revenues are associated with the research collaboration and option agreement with CSL Behring or CSL where we also have the opportunity to receive up to a total of 4.25 million in auction per synthetase program, up to a total of 17 million, if all four synthetase program are advanced by CSL. Our net loss for the three and nine months ended September 30, 2019 was 5.6 million and 17.6 million respectively compared to 7.1 million and 28.2 million for the same period in 2018 respectively. The year-to-date decrease in net income is primarily due to a reduction in expenses of over $10 million. We ended the quarter with 38.1 million in cash, cash equivalent and investment. And for the nine months ended September 30, 2019, our cash burn, net of debt and equity was only 14.8 million. We continue to find ways to operate more efficiently and our quarterly cash burn has now declined for the second consecutive quarters this year. For the year ending 2019, we continue to project a total cash burn at the lower end of our previous guidance range of 23 million to 25 million net of debt and equity. Our long-term debt decreased from 16 million at year end 2018 to 10.6 million as of September 30, 2019. We are on target to have our loans fully repaid by November, 2020. We believe the combination of revenue cost saving measures and equity proceeds over this year gives us sufficient cash to comfortably complete our current Phase 1b/2a clinical trial. Now, I'd like to turn the call back over to Sanjay before we open it up to Q&A.

Sanjay Shukla

Analyst

Thanks Jill. We appreciate your continued interest and support and look forward to providing further updates in the near future. At this time, Jill and I will be happy to take your questions.

Operator

Operator

[Operator Instructions] Our first question comes from the line of Joel Beatty with Citi. Please proceed with your question.

Shawn Egan

Analyst

Hi guys. This is Shawn Egan going in for Joel. Glad to talk with you again. I appreciate the update and thanks for taking my question. Three for me today. You know, in the context of the protocols changed in the clinical trial, maybe you comment how common it is for pulmonary sarcoidosis patients to completely go off steroids?

Sanjay Shukla

Analyst

Sure. Thanks Shawn. Good question here. As we designed our trial, we were looking for a population that required steroids to manage their day-to-day cough and shortness of breath. So these are patients that certainly have moderate disease and based on their PET scans, one would also say they have a disease phenotype that's progressing to becoming fibrotic. And that's the guidance we got from our experts. Getting all steroids is a key component, but the ability for these patients taper off, frankly, is very, very difficult. It's part of the reason why our drug is viewed as an attractive replacement to steroids. And in our trial, the reason we wanted to originally set 5 milligrams as the maintenance doses, we really wanted to test a test our drug to see if whether or not we could spare patients off steroids. These patients are typically on 10 to 25 milligrams, taking them down to 5 was viewed as a sub-therapeutic dose. To be able to completely taper off steroids, I think is a real fantastic goal. And the fact that we're able to in conjunction with PIs agreed to this on the tail end of our protocol, I think is a nice win for us and certainly will be to allow us to win those patients that can accomplish that goal. It's even a greater Delta, and a greater ability to see 1923 utility.

Shawn Egan

Analyst

Great. Thanks, Sanjay. I appreciate the color. Kind of considering the new histological findings you guys have had regarding the expression. Are you able to comment -- are you getting any patients with kind of skin manifestations in your clinical trial?

Sanjay Shukla

Analyst

Yes, so I mean, I wanted to highlight that those were samples taken outside of our trial because we don't have active capture of lung samples in this trial. Many clinical trials, it's hard to get consent especially here in the U.S. to get lung biopsy, especially at this stage. In our trial, you're correct that cutaneous sarcoid is allowed. And if patients have skin manifestations will certainly be able to assay that. At this time, not into the demographics of how many patients have cutaneous symptoms, but I will say that those patients that do have cutaneous manifestations we are going to assay those granulomas, I would expect that once our trial is complete, you might have five or six individuals, maybe upwards to 10 if we're lucky, that have cutaneous manifestation. So I would say stay tuned. I think with regard to those granuloma findings, it really speaks to the first clear connection between neuropilin-2 expression in inflamed granuloma specifically in pulmonary sarcoidosis patient. We knew and we hypothesized based on the literature that neuropilin-2 is highly expressing the inflammatory state especially with T-cells and macrophages. We knew that from the literature and other airway diseases RA, even bladder inflammation some of Dr. Bielenberg's work pointed to that. This was really the first finding here to look specifically at pulmonary sarcoidosis granulomas. And I think we had, as I said, a very striking finding. So, this bodes well for our trials, and certainly those patients that have cutaneous manifestations, we're going to look very closely there to see if a drug has an effect.

Shawn Egan

Analyst

Okay, yes, perfect. That makes a lot of sense. And so my last question, are you able to comment at all with the new Boston Children's collaboration? And maybe to speak a little bit on the biology of NRP-2 kind of in fluid muscles contractility? And why you think it can be effective there?

Sanjay Shukla

Analyst

Sure. So in a number of bladder conditions where it's called caused by an outlet obstruction, you can have neurogenic or non-neurogenic types of bladder disorders. In conditions where the outlet is obstructed and its non-neurogetic to compensate what the smooth muscle does as it starts to get inflamed, and that inflammation is driven by T-cells and some of the same immune cells that you start to see other areas where NRP-2 plays a role. So Dr. Bielenberg had previously published that in inflammatory bladder conditions such as this, with the outlet is obstructive, NRP-2 seems to be highly expressed. So in her view a modulate of NRP-2 could quiesce this inflamed bladder and get it functioning better, as most are aware, once this smooth muscle becomes quite inflamed and over time it become the compensate and this in turn leads to the more chronic bladder condition such as interstitial cystitis for example. So this is an early discovery project, but we also think it has a very clear shot on goal with literature that Dr. Bielenberg has spent a lot of time, understanding the bladder and understanding how neuropilin plays a role in that sort of inflammatory pathology. And similarly, we think if we can modulate inflammation there, we could potentially restore function, and help in a number of conditions, for example, interstitial cystitis being perhaps one of them.

Operator

Operator

Thank you. Our next question comes from the line of Joseph Pantginis with H.C. Wainwright. Please proceed with your question.

Joseph Pantginis

Analyst · H.C. Wainwright. Please proceed with your question.

Hey guys. Good afternoon. Thanks for taking the question and thanks for all the additional color today as well. Wanted to focus on the long-term pipeline expansion, especially with the coming off of the last question in potential in smooth muscle biology, you have a lot of opportunities here as you mentioned with inflammatory disorders in cancer. So I guess my question, which is somewhat rhetorical because it will be researched based is -- do you have any sort of favorite indications yet or things you would like to take forward based on internal expertise versus saying having to maybe do some external IST before you decide to move forward? How do you look to see the pipeline evolve?

Sanjay Shukla

Analyst · H.C. Wainwright. Please proceed with your question.

Great, thanks. Thanks for the question Joe. So we do have a lot of opportunity, but it is about focusing. Internally we're tending to focus a little bit more on the cancer biology side. There are a number of in vivo experiments that we've moved into as it's clear we have some really nice blocking antibodies. With regards to inflammation there's some targeted collaborations such as Dr. Bielenberg that we're working on. I think it's smarter to partner with folks that have a real understanding and those sort of niche indications. So I think the way we're thinking about it is internally perhaps focusing a little bit more on cancer externally through our collaborations we're looking at, at those sort of specialized inflammatory state. I'll make one caveat here that there are a number of, new pieces of literature that have bubbled up with some of the collaborators we work with where they're looking at neuropilin-2 expression in resistant tumors. You will see a number of papers over the last several months that have come out pointing to a potentially an antibody approach to treat prostate or pancreatic, resistant tumors. So those are, those are specialized collaborations where we are also working with those labs that have looking at, for example, neuropilin-2 expression in resistant cancers of, as I said, pancreas and prostate. So I think, I think the way we think about it is sort of continue to leverage that expertise externally. Internally we are focusing a bit more on the cancer biology angle of neuropilin-2.

Joseph Pantginis

Analyst · H.C. Wainwright. Please proceed with your question.

Got it. No, that's very helpful. And if I could just take the, your discussion around the asteroid paper in your clinical studies clinical study one step forward, you did mention for example, that the 5 milligram dose is considered sub-therapeutic. So I was just curious, maybe if you could provide a little more feedback from the PI standpoint about why it would be important to even potentially to go to zero, even though you're reaching the "sub-therapeutic" levels.

Sanjay Shukla

Analyst · H.C. Wainwright. Please proceed with your question.

Sure. So 5 milligrams is certainly sub therapeutic in treating these patients, and we set that as the sort of low bar in this study because we want to, in essence, see the placebo patients, perhaps exacerbate and titrate back up and what we'd like to see the 1923 patients remain at that dose. But 5 milligrams, you can still create some toxic burden. And I think at the end of the day, if you talk to patients in particular, they want to be done with steroids. So in the lens of our trial, if you're doing well at week 16, we discuss this with the PIs, there is an opportunity, if we had amended the protocols we did to maybe just get completely off steroids. So I think it's a nice win for us. In particular, patients are doing well in our trial, and they're 4 months in why not remove steroids. There's an ethical component here that if patients are doing well, why not try to titrate them completely off. So I think this is something we've learned in the course of our trials, and also to spending time with our experts. As you can imagine doing clinical trial as experts begin to get more experienced with their experimental therapy, they're still blinded to whether or not patients are on 23 or placebo. But as they gain more experience around the safety, I think these are the sort of approaches that we want to be flexible to. Because certainly, if we can demonstrate more folks can even taper off steroid completely. I think it just really drives home the potential efficacy of 1923.

Operator

Operator

Thank you. Our next question comes from the line of Robert LeBoyer with Ladenburg Thalmann. Please proceed with your question.

Robert LeBoyer

Analyst · Ladenburg Thalmann. Please proceed with your question.

My question was on pipeline and anything moving in to clinical trial. Pretty much just answered to the previous questions, but if there's anything else to add to that or maybe publicly presented that over next couple of months, that would be helpful?

Sanjay Shukla

Analyst · Ladenburg Thalmann. Please proceed with your question.

Sure, Robert. And I think we tend to be very active with regards to any data we produce, we'd like to get out there in a medical conference in an open forum and be very transparent about it. In actuality, I've kind of advanced this granuloma data because I think it's really important for the market to understand that because that's a real profound finding in my mind to see that, and we will be putting that together in a presentation and targeting a spring medical conference where pulmonologist worldwide can see that data. With regard to our pipeline, as you can imagine, we're currently conducting a number of in-house experiments specifically looking at an NRP-2 biology. We'd love to be active also in the early spring and perhaps some cancer conferences. And then finally, with any of our external collaborations, we want to be very open and transparent should we see some new evidence there and get those out. So I would say right now stay tuned. We don't have a set conference or an abstract announced just yet. But I think conferences such as AACR and ATS in the spring, these are important conferences for us here at aTyr.

Operator

Operator

Thank you. [Operator Instructions] It appears there are no further questions at this time. I'd like to turn it back to Sanjay for closing comments.

Sanjay Shukla

Analyst

Okay. Well, thank you for the excellent questions today. We certainly are looking forward to an update next month as most of you regarding our interim safety data. So, we will be in contact and thanks again for the question.

Operator

Operator

Thank you. Ladies and gentlemen, this concludes today's teleconference. You may disconnect your lines at this time. Thank you for your participation.