Q1 2021 Lyra Therapeutics Inc Earnings Call
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Ladies and gentlemen, please standby your line of Therapeutics Q1, 2021 earnings call.
Call will begin momentarily again, please standby your conference call will begin in minutes. Thank you.
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Welcome to the Lyra Therapeutics first quarter 2021 financial results and corporate update conference call at this time all participants.
All day mode.
Following managements prepared remarks, we will hold there.
The Q&A session as a question that's fine.
Restaurant I've, followed by one on you touched them fun. If anyone has difficulty hearing the country Conference. Please press star zero for operator assistance as a reminder, this call is being recorded today may 11th trying to trend line.
I'd now like to turn the conference.
Keith and Josh.
Please go ahead.
Okay.
Thank you operator.
Joining us on the call today from Lira Therapeutics, our President and Chief Executive Officer of Ria collapses, Chief Financial Officer, Don Elsey, Chief Medical Officer, Rob Kearney, and senior Vice President of commercial strategy and market development Corinne noise.
Earlier today, we released financial results for the first quarter ended March 31 2021.
If you've not received this news release or would simply like to be added to the company's distribution list to receive future releases. Please go to the Investor Relations section of leaders website, which can be found at www dot lira therapeutics at dotcom.
During this conference call management will make forward looking statements, including statements related to Lear's 2021 financial results and guidance and the clinical development of the company's product candidates business strategy and planned operations.
These forward looking statements are based on the company's current expectations and inherently involve significant risks and uncertainties actual.
Actual results and the timing of events could differ materially from those anticipated in such forward looking statements as a result of these risks and uncertainties.
Factors that could cause results to be different from these statements include factors. The company describes in the section titled Risk factors in the company's current report on form 10-Q filed on or about May 11th 2021.
We were cautioned not to place undue reliance on forward looking statements and undertakes no duty or obligation to update any forward looking statements as a result of new information future events or changes in its expectations.
With that I will now turn the call over to Maria Molasses CEO of Lira Therapeutics Maria.
Thank you Steven and welcome everyone to Lear Therapeutics first quarter 2021 financial results Conference call. As a reminder, lira therapeutics goal is to transform the E. N T treatment paradigm I, providing effective solutions for physicians and new treatment options for their patients.
Larry first area of focus is the treatment of chronic rhinosinusitis for which there are an estimated 8 million patients treated each year in the U S with roughly half of them failing medical therapy.
Lear has designed L y or to turn into 'twenty to be disease modifying in best in class Force.
Crs patients who are underserved by current medical management.
<unk> now demonstrated effectiveness in our phase two for underlying ex trail platform lira intends to use L Y our 210 and 220.
A 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 land term phase two study of L. Y our 210 at the combined Otolaryngology spring meetings in April and with the appointment of factor Robert Kern as our Chief Medical Officer, you'll remember.
For that we introduce Rob on our fourth quarter call.
Looking ahead to the remainder of the second quarter, we look forward to sharing with you the feedback from our end of phase two meeting with the F. D. A R. L Y our 210 as well as sharing with you. The top line results from our pharmacokinetic clinical study.
Later in the year, we plan to initiate a phase two clinical trial for our second development candidate <unk> to 'twenty and enlarged matrix using the same 7500 microgram dose as L Y our 210 for patients who have previously undergone sinus surgery, followed by the <unk>.
She Asian of a phase three clinical trial for L y or to turn around year end.
Before I hand, the call over to Rob to cover our clinical pipeline, let me remind you of the highlights from our CASM presentation.
The new data we presented included a 100 per cent of both non polyp and pilot patients. In this study achieved the minimal clinically important difference of eight nine points of symptom improvement and Snot 22 score at week 24. This made L Y our 210.
And the first intranasal implant that has been found to be effective and non polyp crs patients, which represent 90% of the pre surgical C. R. S patient population.
Oh why are 210 also achieved improvement and then the objective imaging endpoint measuring sinus. The pacification at week 24 from baseline and a dose dependent manner with a 7500 microgram dose achieving significant improvement compared to control between the two time point.
Yeah.
Furthermore, L Y our two Penn at the 7500 microgram dose reduce the need for rescue treatment only one patient in the 7500 microgram group required a rescue medication compared to seven patients in the control group over the 24 week treatment period.
Now to give you further insight into our clinical development progress in L Y our 210, Andrew 'twenty I will hand, the call over to Rob can Rob.
Yeah.
Thank you Maria.
Let me take a moment to thank Maria and the entire lira therapeutics team for welcoming me to the company.
I look forward to leveraging my knowledge and experience as we continue to progress.
210, and $2 20 through the clinical pipeline and towards an NDA submission and potential approval.
In addition to the data presented cause them nearer separately shared an analysis of the land and studied it focused on a composite score of three of the Cardinal symptoms of Crs.
<unk> looked at a composite toward that included nasal blockage nasal discharge and facial pain, which are the most prevalent symptoms for surgical line naive crs patients without pulse.
Looking at these three cardinal symptoms with a single administration MYR to 10 achieved statistically significant improvement in the composite score compared to control and week 24, with a P value of 0.003.
And at earlier time points as well.
As a reminder, our goal was to come out of this study with insight into what might be the most relevant endpoint for our pivotal study and we believe that the three cardinal symptoms could be the most appropriate we will have more to say on this matter when we share the feedback from our end of phase two meeting with the FDA.
Leveraging the clinical success to date of <unk> to 10, we're also preparing to initiate a phase two study for <unk> to 'twenty and previously operating patients.
Will occur in the second half of the year, we will use the 7500 microgram doses achieved positive results from railway are 210 in the phase II study.
Combined we believe that <unk> hundred 20 could offer Ent's a complete suite of first in class products to treat the majority of Crs patients who'd walk into their office. We believe that this will be a key commercial advantage versus current product offerings.
With that I will now hand, the call over to Don to summarize <unk> financial results for the first quarter.
Don.
Thank you, Rob starting with our cash and cash equivalents balance. We ended the first quarter was $66 $1 million compared with $74 6 million as of June.
December 31 2020.
Total operating expenses for the first quarter with four 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 and Paul So I will not go through the full details on this fall.
In terms of financial guidance and as we've previously stated we believe that lira has sufficient cash to fund the company through planned operations into 2023.
Finally, <unk> shares outstanding as of March 32021 were approximately 13 million shares with that I will turn the call back to Maria.
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.
Installation of manufacturing equipment and infrastructure at our CMO has been completed which has resulted in the commencement of Lyris first manufacturing lots of support the IMD supplement and the commencement of our phase III clinical trial for L y or to turn around year end.
Again in the remainder of the second quarter, we will share the highlights of the end of phase II meeting with the FDA and the top line results from our pharmacokinetic clinical study of L Y our 210.
Before I open up the call for questions, Let me talk a little bit about the PK study and its background.
Case study is our third clinical study for L Y our 210 and enroll day planned 24 U S patients and will be a critical component of the company's strategy for obtaining regulatory approval thorough 505 day, two new drug application.
In terms of what you should expect us to announce we anticipate sharing top line results at a high level as we plan to present the data at a medical meeting this fall.
In terms of results, we are looking for firstly mometasone pharmacokinetic data that confirms L Y our two tenders applicable for a five O five P. Two pathway and safety and usability information for L. Y are to turn that confirm what we have seen so far in our phase one.
And phase two trials.
The trials conducted in the United States has also given us our first and that's U S experience with U S site and the learnings will facilitate our phase III trial for <unk> to 10.
As you will recall from our comments of Doctor all the leading enroll her in the PK trial. The anecdotal evidence from this study is encouraging and we're excited to share it all with you soon.
With that I will now open up the call for questions operator.
Ladies and gentlemen, if you have a question at this time. Please press Star then the number one on your Touchtone phone.
Again, that's farther and day number one on your Touchtone phone.
Your first question comes from the line of Robert Hazlett from D. P. I G. Your line is open.
Hi, This is Perry on the line for Bert.
Thanks for taking the question and congratulations on the progress.
I am curious about the time point upcoming for the potential phase III trial.
Youre seeing efficacy based on Atlanta, both in terms of the Snot 22 score as well as the <unk> CSS.
Is there a time point our.
Debt.
Currently more.
Interested in is it at the 24 week time point.
Just just any any thoughts on how you're going about choosing a time point.
For phase III.
Thank you Perry.
Yes, so we when we look at are not 22 resolved when we look at that for Cardinal symptoms or the three cardinal symptom.
We certainly see efficacy and statistically significant improvement over the control.
Our debt.
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 share.
We see a P value of 0.003 at 24 weeks. So certainly that is going to make sense for us. He is one of those later time points.
Yeah.
Okay. Thanks, Maria that's very helpful. And then just one other question on <unk>.
I guess the status of manufacturing capabilities.
In terms of readiness for the phase III trial and then.
How how that's progressing over the next few months and then I guess.
Beyond that I know, it's quite early but.
Do you what do you anticipate in terms of commercial readiness.
Beyond the phase III manufacturing build out.
Thanks Perry.
So we have begun the process of technology transfer is 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 you're aware that we manufacture the product in house.
For phase one for phase two.
And so our engineers our scientists are at the contract manufacturer every week.
Another highlight of the manufacturer that we selected as they're very strong in automation.
It is going to be key for us, especially whereas you mentioned commercial readiness, there's millions of patients out there with Crs. So it's going to be really important for us to be able to automate. So we can make them the products for that the millions of patients that are out there.
And certainly as we think about commercialization will be anticipate being ready as we are conducting.
Conducting the phase III trial that is going to give us the time to put out of the automation in place to be ready.
Great. Thank you and looking forward to continued progress thanks.
Thanks Perry.
Sure.
Yeah.
Your next question comes from the line of Jason <unk> from Bank of America. Your line is open.
Hey, good evening.
Heading into the FDA meeting can you just remind us maybe some moves.
The key agenda points potential variables and.
How you're thinking about perhaps.
The study size and inclusion criteria to ensure you get the broadest label for both pulp and non polyps. Thanks.
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 two we studied for Cardinal symptoms. We've now also published and presented are the individual symptoms and when we look at the composite of the three that gives us a high degree of significance.
And and so we certainly want to set up the program for success, we're gonna be looking at.
The time point and the the composite of Cardinal symptoms.
And that is going to be the strongest in debt our data supports.
So we certainly will be talking to the F D a about a debt.
The composite that we would be proposing and also in terms of the time point as I mentioned, a later time point up to a 24 weeks that'll be a key for US will also be talking about some of the key secondary end point, certainly it's a symptomatic disease. So.
The individual symptoms are gonna be a key also other types of endpoints like what we did in the phase two rescue treatments and 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.
The statistics are very strong so.
We're estimating about 350 patients we're gonna be proposing a the high dose of 7500 micrograms. So those are some of the items that I will be discussing and that we're gonna be wanting to reach agreement on.
Got it great. Thanks, so much.
Sure. Thanks.
Once again to ask a question you will need to press Star then the number one on your Touchtone telephone again thats far than day number one on your Touchtone telephone.
Your next question comes from the line of Chris Howerton from Jefferies. Your line is open.
Hey, there.
You for taking the questions 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 U S experience from the PK study and how that may transfer to the.
The design and the conduct of the phase III study.
And then another question that I had was.
With respect to the product to 'twenty has the final design.
All of the features of debt been finalized at this point or is there additional tweaks to that product itself.
And then the last question is maybe for Don and just maybe help us understand what.
What kind of is included in the financial guidance in terms of the planned operations such as what clinical trials and so force may or may not be included in that thank you.
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 learnings from the U S experience and the phase III study conduct.
And then Don after that.
Terms of the final design, yes that is that is its finalized its 7500 microgram dose not only that but that dose and what we are the data that we have supporting the safety of that dose from the efficacy is the same dose that then we're also going to use on that.
L Y our two top 20 product candidate. So we don't anticipate we don't expect any tweaks at all the product that we tested and in the phase two will be what we're carrying forward into the phase III study.
Rob.
I think that the key takeaways.
American experience are.
The.
Readiness and relative.
I don't want to get out.
One of my skis here, but the ease of recruitment.
We're able to attract U S patients without a great deal of difficulty and also the ease of insertion the acceptance of the whole idea.
The U S market I think.
<unk> very well towards the.
The future and our ability to readily.
Uh huh.
While a lot of patients for the phase III trial.
Okay great.
Maybe Don before you answer Maria I was just and just to clarify it was asking about $2 20 in terms of the form factor for that product.
I'm, sorry, I wonder if that afterwards, so yeah. So in terms of 220 <unk>.
What we have said is we're taking to devise actually into the <unk> into the phase two trial.
Now as you know that does that does our technology as a platform we can alter the the cell size, which provides more.
More surface area coverage or less surface area coverage.
And so we are planning on taking the two design forward that hasnt changed and both of those designs will have the 7500 microgram dose on them does that answer your question Chris.
Yes, yes. It does thank you alright.
Alright, sorry about that.
Don do you want to take the next one.
Yeah.
Hello, once again to ask a question that'll be star one on your Touchtone telephone. Your next question comes from the line of Tim Lugo from William Blair. Your line is open.
Hey, this is lachlan on for Tim Thanks for taking the questions.
Yes al.
Stopped we just saw.
Aside from obviously, the FDA meeting and aligning all the trial design is.
The only other gating factors to starting the phase III the validation.
Product from the CMO.
When you sort of what's the kind of timeline on that.
And second question are you.
Are you planning to hold discussions with regulators outside the U S. At all around the design of the phase III or.
Are you just focusing on the U S for now and once you've got that nailed down you will stuff.
Okay.
If at all.
Don.
Good luck to you as well.
Two questions.
Hey, Hi, Thanks for the question and tell your question Lachlan is starting the phase III gating item.
So that the gating items certainly are the final protocol that'll get submitted to the FDA and and then what we'll do with that protocol is then you then use it to begin to get the study going in.
IRB approval et cetera, getting our sites up and running.
And so we will 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 are gating. The start of the trial and we feel very confident about how things are progressing on all fronts.
And then in terms of your question about regulators outside of the U S. Our focus is on the U S.
For this study and we may have sites outside the U S.
So right now we are however focused on the United States in terms of that the trial and then in terms of just your comment pertains to perhaps commercialization outside of that the U S. One of the things that we have.
Mentioned is that we will be seeking partnerships outside the U S. So.
That is certainly something that we are open to and and.
Are pursuing.
So so Maria this is Tom if I can jump in sorry about that would be a little power surge here.
So if I heard the question correctly before I got cut off at what clinical trials were.
Contained in our financial guidance is that correct.
Yeah.
Yes.
Oh I would assume yes.
Correct.
So what we've got in that guidance is the phase III being undertaken four to 10 and a phase II per to 'twenty.
At the approximate patient count that debt.
Maria was talking about.
Yeah.
Thank you.
Once again to ask a question you will need the breast on standard number one on your Touchtone phone again, that's far than day number one on your Touchtone phone.
There are no further questions at this time I would now like to turn the conference back to Maria Paula.
Thank you operator, Leer I have 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.
We are well positioned for an exciting future and remain very confident in the ability of L. Y our 210 and 220 <unk> to provide a meaningful difference in the way Crs was treated here in the U S and also elsewhere in the world.
In the coming months, we plan to attend the Bank of America Jefferies and William Blair Health care conferences and welcome your requests for meetings during those events.
With that I would like to thank you all for participating in today's call.
Ladies and gentlemen, this concludes today's conference call. Thank you for participating you may now disconnect.
Okay.
Yes.
Yeah.
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