Lyra Therapeutics, Inc. (LYRA) on Q1 2021 Results - Earnings Call Transcript
Operator: Welcome to the Lyra Therapeutics First Quarter 2021 Financial Results and Corporate Update Conference Call. At this time, all participants are in a listen-only mode. Following the management's prepared remarks, we will hold a Q&A session. . As a reminder, this call is being recorded today. May 11, 2021. I would now like to turn the conference call over to Stephen Jasper from Gilmartin Group. Please go ahead.
Stephen Jasper: Thank you, operator. Joining us on the call today from Lyra Therapeutics are President and Chief Executive Officer, Maria Palasis; Chief Financial Officer, Don Elsey; Chief Medical Officer, Rob Kern; and Senior Vice President of Commercial Strategy and Market Development, Corinne Noyes.
Maria Palasis: Thank you, Steven. And welcome everyone to Lyra Therapeutics first quarter 2021 financial results conference call. As a reminder, Lyra Therapeutics' goal is to transform the ENT treatment paradigm by providing effective solutions for physicians and new treatment options for their patients. Lyra’s first area of focus is the treatment of chronic rhinosinusitis for which there are an estimated 8 million patients treated each year in the US with roughly half of them failing medical therapy. Lyra has designed LYR-210 and LYR-220 to be disease modifying and best-in-class for CRS patients who are underserved by current medical management. Having now demonstrated, effectiveness in our Phase 2, for underlying XTreo platforms, Lyra intends to use LYR-210 and 220 as the foundation, on which we build a leading ear, nose and throat company. We made further progress towards this goal in the first quarter with the presentation of the full data from our LANTERN Phase 2 study of LYR-210 at the Combined Otolaryngology Spring Meetings in April. And with the appointment of Dr. Robert Kern as our Chief Medical Officer, you will remember that we introduced Rob on our fourth quarter call.
Rob Kern: Thank you, Maria. First, let me take a moment to thank Maria and the entire Lyra Therapeutics team for welcoming me to the company. I look forward to leveraging my knowledge and experiences as we continue to progress LYR-210 and LYR-220 through the clinical pipeline and towards an NDA submission and potential approval. In addition to the data presented at COSM, Lyra separately shared an analysis of the LANTERN study that focused on a composite score of three of the cardinal symptoms of CRS. Lyra looked at the composite score that included nasal blockage, nasal discharge and facial pain, which are the most prevalent symptoms for surgical naive CRS patients without polyps. Looking at these three cardinal symptoms with a single administration, LYR-210 achieved statistically significant improvement in the composite score compared to control at we 24 with a p value of 0.003 and at earlier time points as well.
Don Elsey: Thank you, Rob. Starting with our cash and cash equivalents balance, we ended the first quarter with $66.1 million, compared with $74.6 million as of December 31st, 2020. Total operating expenses for the first quarter were $7.8 million compared to $4.2 million for the same period in 2020. Net loss for the first quarter was $7.8 million. The earnings release we issued earlier today outlines our financial results in full. So, I will not go through the full details on this call. In terms of financial guidance and as we previously stated, we believe that Lyra has sufficient cash to fund the company through planned operations into 2023. Finally, Lyra shares outstanding as of March 30th, 2021 were approximately 13 million shares. With that, I will turn the call back to Maria.
Maria Palasis: Thank you, Don. In addition to our clinical progress, I am pleased to report that the tech transfer to our contract manufacturer is on track. The installation of manufacturing equipment and infrastructure at our CMO has been completed, which has resulted in the commencement of Lyra's first manufacturing lot to support the IND supplement and the commencement of our Phase 3 clinical trial for LYR-210 around year end. Again in the remainder of the second quarter, we will share the highlights of the end of Phase 2 meeting with the FDA and the topline results from our pharmacokinetic clinical study of LYR-210. Before I open up for call for questions, let me talk a little bit about the PK study and its background. The PK study is our third clinical study for LYR-210 and enrolls a planned 24 US patients and will be a critical component of the company's strategy for obtaining regulatory approval through a 505(b)(2) new drug application.
Operator: First question comes from the line of Robert Hazlett from BTIG. Your line is now open.
Perry Mayo-Malasky: Hi. This is Perry on the line for Bert. Thanks for taking the question and congratulations on the progress. I'm curious about the time point upcoming for the potential Phase 3 trial. You're seeing efficacy based on LANTERN, both in terms of the SNOT-22 score as well as a three CSS. Is there a time point that you're currently more interested in? Is it at the 24 week time points? Just any thoughts on how you're going about choosing a time point for Phase 3?
Maria Palasis: Thank you, Perry. Yes. So, we when we look at our SNOT-22 results, when we look at the four cardinal symptoms or the three Cardinal symptoms, we certainly see efficacy and statistically significant improvement over the control out at 16 weeks, 20 weeks, 24 weeks. And so certainly well, what we would propose to use moving forward is a later time point up to 24 weeks would make sense. If you look at the three cardinal symptoms that we shared, we see a P value of 0.003 at 24 weeks. So certainly that is going to make sense for us to use one of those later time points.
Perry Mayo-Malasky: Okay. Thanks, Maria. That's very helpful. And then just one other question on, I guess, the status of manufacturing capabilities in terms of readiness for the Phase 3 trial, and then how that's progressing over the next few months. And then, I guess beyond that, and it's quite early, but what do you anticipate in terms of commercial readiness beyond the Phase 3 manufacturing build up?
Maria Palasis: Thanks, Perry. So we have begun the process of technology transfer. It's going very well. We're really excited about the partner that we've chosen to work with us. We are working with them to scale up the manufacturing. I think they’re aware that we manufacture the product in-house for Phase 1 and Phase 2. And so, our engineers, our scientists are at the contract manufacturer every week.
Perry Mayo-Malasky: Great, thank you. And looking forward to continued progress. Thanks.
Maria Palasis: Thanks, Perry.
Operator: Your next question comes from the line of Jason Gerberry from Bank of America. Your line is open.
Jason Gerberry: All right, good evening. Just heading into the FDA meeting, could you just remind us maybe some of the key agenda points, potential variables, and how you're thinking about perhaps, study size and inclusion criteria to ensure you get the broadest label for both polyp and non-polyps? Thanks.
Maria Palasis: Thanks, Jason. In terms of the agenda, first and foremost, it's the primary endpoint. And as we mentioned, we'll be looking at Cardinal symptoms in the Phase II, we studied. For cardinal symptoms, we've now also published and presented the individual symptoms and when we look at it as composite of the three, that gives us a high degree of significance. And so we certainly want to set up the program for success, we're going to be looking at the time point and the composite of Cardinal symptoms, that is going to be the strongest and that our data support. So we certainly will be talking to the FDA about the composite that we would be proposing. And also, in terms of the time point, as I mentioned, a later time point up to 24 weeks, that'll be key for us. We'll also be talking about some of the key secondary endpoints certainly, it's a symptomatic disease. So, the individual symptoms are going to be key. Also, other types of endpoints, like what we did in the Phase II Rescue treatments and how those will fit in. In terms of the size, again, we have planned for approximately 350 patients. And that is very much driven by the number of exposures that we think we're going to need in terms of the statistics. We -- the statistics are very strong. So, we're estimating about 350 patients, we're going to be proposing the high dose of 7,500 micrograms. So those are some of the items that we'll be discussing and that we're going to be wanting to reach agreement on.
Jason Gerberry: Got it? Great. Thanks so much.
Maria Palasis: Sure, thanks.
Operator: Your next question comes from the line of Chris Howerton from Jefferies. Your line is open.
Chris Howerton: Hey there. Thank you for taking the question and congratulations on the progress as well. So for me, I think, I'd be curious to know what the specific learnings you took away from the US experience from the PK study and how that may transfer to the design in the conduct of the Phase III study? And then another question that I had was, with respect to the product 220 has the final design in all the features have that been finalized at this point? Are there additional tweaks to that product itself? And then the last question is maybe for Don, and just maybe help us understand what kind of -- is included in the financial guidance in terms of the planned operations such as, you know, what clinical trials and so forth may or may not be included in that? Thank you.
Maria Palasis: Thank you, Chris. And I'll start with the final design question and then I'm going to turn it over to Rob. He can speak about the learning of -- from the US experience and the Phase III study conduct and then Don after that. So, in terms of the final design, yes, that is -- it's finalized. It's 7,500 microgram dose. Not only that, but that dose and what we – as the data that we have supporting the safety of that dose and the efficacy is the same dose that then we're also going to use the LYR-220 product candidate. So we don't anticipate. We don't expect any tweaks at all. The products that we tested in the Phase 2 will be what we're carrying forward into the Phase 3 study. Rob?
Rob Kern: Yeah, I think that the key takeaways in the American experience are the readiness and relative. I don't want to get out in front of my seats here. But the ease of recruitment, we were able to attract US patients without a great deal of difficulty. And also the ease and assertion, the acceptance of the whole idea in the US market, I think, speak very well towards the future and our ability to readily acquire a lot of patients for the Phase 3 trial.
Chris Howerton: Okay, great. Maybe Don, before you answer. Maria, I was just – just to clarify, I was asking about 220 in terms of the form factor for that product?
Maria Palasis: I'm sorry, I wondered that afterwards. So yeah, so in terms of 220, what we have said is we're taking two designs actually into the – into the Phase 2 trial. Now, as you know, that our technology is a platform. We can alter the cell size, which provides more surface area coverage or less surface area coverage. And so we are planning on taking the two designs forward, that hasn't changed. And both of those designs will have the 7,500 microgram dose on them. Does that answer your question, Chris?
Chris Howerton: Yeah, yes, it does. Thank you.
Maria Palasis: All right. Sorry about that. Don, do you want to take the next one?
Don Elsey: Hello?
Operator: Your next question comes from the line of Tim Lugo from William Blair. Your line is now open.
Unidentified Analyst: Hey, this is Lachlan on for Tim, thanks for taking the questions. I guess, I'll start with just aside from obviously, the FDA meeting and aligning on the trials, design, is the only other gating factor for starting the Phase 3, the validation of product from the CMO. And when sort of -- what's the kind of timeline on that? Second question, are you are you planning to hold discussions with regulators outside the US at all around the design of Phase 3? Or are you just focusing on us for now and once you've got that nailed down, you'll start digging at US if at all. And then obviously, Don, I'd love to hear you as well on the last question.
Maria Palasis: Hey, hi. Thanks for the question. And so your question, Lachlan is starting the Phase 3 gating items. So the gating items certainly are the final protocol that'll get submitted to the FDA and then what we'll do with that protocol is, then use it to begin to get the study going in terms of IRB approval, et cetera, getting our sites up and running. And so we'll have to be doing that in parallel. And then, the next item that's going to be critical certainly is getting the product to the site. So all of those things, that are gating the start of the trial, and we feel very confident about how things are progressing on all fronts. Then, in terms of your question about regulators outside of the US, our focus is on the US for this study. And we may have sites outside the US. So right now, we are however, focused on the United States in terms of the trial. And then in terms of as your comment pertains to perhaps commercialization outside of the US, when other thing that we have mentioned is that, we will be seeking partnerships outside the US. So, that is certainly something that we are open to and are pursuing.
Don Elsey: So Maria this is done, if I can jump in, sorry about that we had a little power surge here. So if I heard the question correctly before I got cut off it, what clinical trials were contained in the financial guidance? Is that correct?
Rob Kern: I will assume.
Don Elsey: Yeah. That was correct. So, what we've got in that guidance is the Phase 3 being undertaken four to 10. And the thing is two for 220 at the approximate patient count that that Maria was talking about.
Unidentified Analyst: Okay. Thank you.
Operator: There are no further questions at this time. I would now like to turn the conference back to, Maria Palasis.
Maria Palasis: Thank you, Operator. Lyra has begun 2021 with strong momentum, which we plan to build upon as we further our clinical pipeline in the second half of the year. We are well positioned for an exciting future and remain very confident in the ability of LYR-210 and LYR-220 to provide a meaningful difference in the way CRS is treated here in the US and also elsewhere in the world. In the coming months, we plan to attend the Bank of America, Jefferies and William Blair Healthcare conferences, and welcome your request for meetings during those events. With that, I would like to thank you all for participating in today's call.
Operator: Ladies and gentlemen, this concludes today's conference call. Thank your participating. You may now disconnect.
