Q1 2020 Earnings Call
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Now my pleasure they have a conference over to Mr. Joe abroad.
Tires, Chief Financial Officer, Ms. Breakfast you may begin.
Thank you and good afternoon, everyone. Thank you for joining us today to discuss eight tires first quarter operating results in corporate update we're 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 18, why our 1923, and our research program and nerve Killen too for NRT too and she R&D Sensitized Biology, I will then review the financial results and our current financial position before handing it back to Sanjay to open the call left for any questions before I begin.
I would like to remind everyone that except for statements of historical Socs. 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 could differ materially from those in such forward looking statements.
Please see the forward looking statements disclaimer and the company's press release issued this afternoon as well, it's a risk factors and the company's FCC 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 of facts and circumstances underlying these forward looking statements may change.
Except as required by law you try to find that disclaims any obligation to update these forward looking statements to reflect future information events or circumstances.
Ill now turn call over to Sanjay.
Thank you Jill.
Good afternoon, everyone and thank you for joining us for our first quarter 2020 results conference call.
Before we begin I would like to say on behalf of a tire and our employees.
We stand in support of Baltimore Health care providers Central personnel.
Those patients and community as we continue to work through the Onboarding Cobot 19 pandemic.
Reacted accordingly to implementation plan to ensure the safety of everyone involved with our clinical and research programs.
While minimizing disruption to our business operations.
We continue to abide by going to directors, an operator business for a moment.
In order to play a role and minimizing the spread of environments to our employees and their families and he is a burden on our health care system.
Now, let's get started with a quarterly review and corporate update.
During the first quarter 2020 in subsequent periods.
Our progressive development on worked quite well.
Around for 80 wire or 1923.
Including entering in major collaboration for extended to development.
And announcing a neutral and koby like T patients.
We also advanced our pipeline of discovery programs and strengthened our balance sheet.
Enabling us to further advance these programs towards important and potentially value creating milestones.
As we begin I'll summarize the key highlights from the first quarter in subsequent periods.
We announced the phase two trial, and making 20 greenco. The 19 patients with severe restaurant complications following up the acceptance of an investigational new drug application.
We entered into collaboration and license agreement drawing from soon.
The development and commercialization of 1923, four interstitial lung disease for royalties.
In Japan for up to $175 million.
We published two abstracts at the American Journal Abreast story in critical care Medicine will be presented at the upcoming American Thoracic Society International Conference.
We announced the appointment of Dr. orphan Curio, a leading cancer researchers at the University in Massachusetts Medical School has a scientific advisor to the company and together, we'll be presenting a poster at the upcoming American Association cancer Research annual meeting.
We announced the award of a Hong Kong government grants to build a high throughput platform for the development of a bi specific antibodies further building out our NERC someone to antibody development silver.
We published a paper and the nature journal cellular and molecular immunology, highlighting the essential role that has to be able to already since assays plays in the modulation of immune cell engagement.
Broad range of disease states, including royalties.
And finally, we've raised gross proceeds of approximately $20.7 million more public offering of common stock.
We've accomplished quite a great deal thus far in 2020, and we continue to make significant progress in the second quarter.
Today I will take some time provided an update on our clinical program with our lead therapeutic candidate 1923, including the status of both our fees wouldn't be to a trial in pulmonary sarcoidosis.
As well as our phase two trial in coking 19 patients.
I'm also comment on our ongoing preclinical research and development efforts for programs and NRP too and TRT sensitive biology.
Joe will conclude with a review of our financial position.
Let's begin with an update on this program for making 23.
Well, we've definitely seen 23 clinically we continue to explore and validate the properties will be NRP to signaling pathway and key attributes of 1923 that make it a compelling candidate and immune mediated diseases.
We announced just last week the publication of two abstracts, and the American Journal abreast already critical care medicine.
The findings confirm significant role on NRP two in serious inflammatory diseases.
There are elucidate the mechanism of action of 1923.
And its ability to selectively binds to this unique target.
In summary, these findings report that NRP tumors express and readily detectable within the granular on wasn't long and skin samples of sarcoidosis friendship.
Through this research we demonstrate that NRP to expression can be detected on key immune cells that are known to play an important role in inflammation, Greg you almost four Mitch.
Additional research published demonstrates a 923, specifically and selectively binds to NRP too.
On the cell surface.
These findings characterized the molecular basis of 1920, threes immuno modulatory properties and indicate that the NRP to signaling pathway could be a novel therapeutic targets for immune mediated diseases and highlight its potential to exert its effect on various immune cells.
Now, let's discuss our clinical program for 1923.
Well begin with an update on our streets wouldn't be to a trial 1923 in patients with all make circumstances.
As a reminder, this is a randomized double blind placebo controlled multiple ascending dose clinical trial and 36 pulmonary sarcoidosis page.
In December we announced interim safety data from 15 pulmonary sarcoidosis patients with received a minimum of one dose of blinded study drug.
Which was observed to be generally safe well tolerated no drug related serious adverse events.
In addition, during the first quarter for first quarter.
Our independent data safety monitoring board completed its second safety would allowing us to move from our three milligrams per kilogram dose.
Tests are five milligram per kilogram dosing cohort three.
A final group of patients in our study.
We announced in March due to colder today due to the Coca 19th endemic and its impact on clinical trial conduct.
Please turn of enrollment and timing of our topline results from this phase one be two way study would be delay.
At that time, we were enrolling patients in the aforementioned Coordthree where study.
Well some of our investigational sites have remained active many sites had to pause.
Recruitment rates for Coordthree have slowed and some patients in cohort two I've missed doses, which in some cases has led to their study discontinuation.
We're currently evaluating strategy to ensure the trial meets to required number that valuable patients.
Including potentially recruiting more than 36 patients in our study.
I'm happy to report that we are starting to see reopening plans and all our sites some sites, putting institutional procedures in place to prepare to open enrollment at the end of May early June.
We're working closely with each site to understand before we start plants. So lets say incorporate an overall strategy for the completion of the study while minimizing patient and provider since you list.
As we announced back in January we continue to progress our global development strategy for 1923 by entering into a collaboration and license agreement drawn pharmaceutical company.
For the development and commercialization of 1920 reefer aisle these in Japan.
The initial development activities for commencing clinical work in Japan.
Including dialogue with the relevant regulatory agency, the pharmaceuticals and medical devices agency.
Our underway and rebate remained very much on track.
Now, let's turn to our phase two trial of 1923, and Kobin 19 patients.
As we determined the best course of action for 1923 trial components Arkon doses.
Why did the pandemic, we look to our own science to see how we maybe able to contribute to the immediate need for effective treatments for Coca Nike.
We learned early in this crisis that the inflammatory lung injury related to cope with 19 shared some remarkable similarities to those observed in initial lung disease.
Many cobot 19 patients with severe disease experienced serious sometimes fatal.
What's already complications caused by an excessive inflammatory response in the low primarily driven by T cells.
Thank you 23 has been shown preclinically to down regulate T cell responses, thereby dampening the inflammatory cytokine into the kind signaling.
Both of which I've been implicated in the severe over 19 cases.
In addition to these anti inflammatory properties 1923 has also been shown to improve lung function in animal models.
Well the immune mediated acute lung injury.
Hi, targeting average immune responses, we believe that 1920 threes mechanism of action has substantial overlap with this disease pathology and presents a compelling opportunity to potentially treat this subset of coking 19 patients.
We announced in March we had approached the FDA regarding testing 1920 green called the Mexican peso.
In April we announced that the F. you had accepted our idea application for phase two randomized double blind placebo controlled study of 1923, and covert 19 patients with severe respiratory complication.
The trial will include 30 hospitalized coking 19 positive patients with severe respiratory complication.
We do not require mechanical ventilation.
Patients enrolled in the trial will be assigned to one of three cohorts of 10 patients each.
Patients will receive.
Single dose of either one or three milligrams per kilogram of 1923 or placebo.
To be administered in the hospital.
Patients will be followed for 60 days post treatment and we plan to enroll at up to 10 centers in the U.S.
Well the primary endpoint and studies to assess the safety and Tolerability single dose of 1923 in this acute setting. We will also focused on a number of key clinical outcome measures, including but not limited to fever hypoxia.
And inflammatory biomarkers.
We have identified in our game and are engaged in start up activities with target sites throughout the U.S., including some of the same sites that are part of our only started its trial.
We expect the first sight to be ready to enroll and potentially dose our first patient within the coming weeks.
The initiation of the trial is an important milestone for making 23 clinical program.
He tire has an opportunity to fundamentally addressed this public health crisis with a novel therapies, specifically designed to address her aberrant immune response and inflammation and alone.
We plan to provide further updates at the trough progress.
Now, let's turn to our research program in NRP too as we continue to invest in our pipeline opportunities, including diseases disease areas outside of biopsies.
Our in House research and discovery program in academic collaborations continue to yield published data.
Allergy and RP to biology, and the potential therapeutic application of NRP to antibodies for a variety of disease settings, including cancer and inflammatory disorders.
We are pleased to be working in collaboration Dr. Arthur maturity.
One of our key scientific advisors and his alive at the University left Massachusetts Medical School.
There is a growing body of evidence, indicating that the expression of NRP too.
Isn't rich in breast cancer stem cells, and then NRP to signaling is critical for breast cancer stem cell function and resistance development.
This provides strong rational rationale for targeting NRP too as a therapeutic target.
Through our collaboration with Dr. material, we explored the use of one of our NRP to antibodies in triple negative breast cancer models.
Results from this collaboration are included in an abstract.
Accepted by the American Association for cancer Research for a poster at its upcoming annual meeting in June.
Finally, we look to continue to leverage our broad portfolio CRT securities intellectual property to internal discovery programs on external collaboration.
Through our research collaboration with CSL, Behring, and leading global Biotrue Cubic's company.
We seek to identify up to four new I'd be candidates from our portfolio Tierone since it seems like Pete.
We have extended some of our research plans to account for a slight delay completing the first stage of the program primarily due to the disruption from the colder 19th endeavor.
Both parties have agreed that funding for this collaboration will continue.
And are committed to achieving the milestones of the program.
We plan on providing an update on this collaboration later in the year.
Overall, we're pleased with the progress we've made today 20 twond.
We see signs that our pulmonary sarcoidosis trial will be restarting coordthree enrollment shortly.
With the announcement of the trial and Coca 19 patients. We're now investigating 1923 into clinical setting.
We expect to report data from October 19 trial.
Later this year.
We also look forward to initiating clinical work for 1923 in Japan.
Sure cure in partnership.
Our research and discovery programs continue to generate published data that validate our site.
Both from our work internally and through established external partnerships.
With that I'd like to turn it over to our Chief Financial Officer, Joe brought foot to review our financial results.
Thank you Sanjay.
Revenues were 8.1 million for the three months ended March 31st 2020, consisting primarily of licensing revenue from the Kieran agreement Research and development expenses were 3.6 million a 3.3 million for the three months ended March 31st 2020, and 2019, respectively. The increase.
For research and development expenses due primarily to the progression of our 1923 phase one be to a clinical trial in pulmonary sarcoidosis.
Patients, which was initiated in December 2018.
General and administrative expenses were consistent between quarters at 2.6 2.5 million for the three months ended March 31st 2020, and 2019, respectively.
As of March 31st 2028 have 49.8 million in cash cash equivalents and investment which is consistent with our prior guidance now I'd like to turn the call back over to Sanjay before we open it up to Q I know.
Thanks Jill.
Before opening the call for questions I want to reiterate our commitment.
Our clinical and research programs in this difficult time.
We aim to potentially help address the global public health crisis.
Hi, investigating 1923, and a subset of coking 19 patients.
1923 is not every purpose therapy as it has been rigorously designed and developed to target I've written immune responses in the low.
We continue to focus on our mission to develop new medicines for underserved population.
And our strong scientific rationale for 1923, not only in pulmonary sarcoidosis, but also cover 19 exemplifies this key corporate principle.
We appreciate your interest and continued support and look forward to providing updates in the future.
This time, John I will be happy to take your questions.
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Scott and then one on your telephone to withdraw your question press the pound please standby compiled acuity roster.
Your first question comes from the line of Hartaj Singh from Oppenheimer. Your line is open.
Great. Thank you thanks for the questions and.
I'm happy to hear and want to seek them out and also all the programs and I know these times Ardmore and Mckee.
Well first of all fronts.
So just a couple of separate questions. One is on the corporate banking a project yeah.
The pay the people to be selecting that you we put it all goes up to defer arms I wouldn't be beyond sort of black Crown standard of care I know that.
We don't want things that Weve reading is done.
Various hospitals have different sometimes different ways of treating corporate banking patients, especially as they progress from big severe to critical how are you sort of handled that and then you know what kind of background medication you know like Rem density or anything else will be allowed a that's number one and then number two.
You know when you're right I know that the safety part of my making 23 has Oh, you know you've gotten good data there, but what exactly sort of give you'd be looking for that data of 60 days post dosing.
Too you know have a good feeling that you can move the project forward not just got a couple Paul's questions on pulmonary separately.
Sure our touch yeah, good questions there so.
First of all your question was about background therapy and from got severe has now of course been approved a to be used in these patients.
We don't have a lot of data around which subset of patients will be prioritize nor do we at this point.
See from does appear will be distributed quite a bit it had a number of hospitals. So I think that's still being sorted but of course that will be a therapy, though that will be allowed as it is now considered standard of care.
When you talk about some of the other therapies that are being.
Try it out in these in these patients we really see our drug position a little bit upstream from some of the monoclonal antibodies targeting vital six or TNF for GM CSF.
Which are being a bit more reserved for the most severe patients those patients that are.
Quite often Ben.
On a ventilator four or quite severely sick.
So we're targeting those patients that.
Don't require necessarily those therapies, we'd like to actually tune down the immune system before the patients really go into that florid cytokine storm.
The other thing is there are still some trials out there where they're looking at hydroxy Clark win.
But we don't really see harp protocol interfering too much would that protocol.
As we also see some of those protocols winding down at a number centers. So that's the first question around.
Kind of what other sort of concomitant medications here would be important.
And I think were industry or might be might be the only one that for our protocol.
You know would would be allowed up your second question was really about the endpoints.
So it is as the FDA wants us to really make sure that it's safe and these patients and.
Weve established to a certain degree some safety and Tolerability data points, our dosing patients. That's good we want to continue to see that in these patients and we expect we will when it comes to activity.
Fever, and I'd Pocs year, two very clinical outcomes were came came rising to the top when you talk to the experts they really think our drug can impact, perhaps shorten the duration of fever and and.
Get to a quicker normalization in hypoxia and these patients.
When you look at the inflammatory biomarkers many these patients coming in with.
A number of these inflammatory cytokine that are up regulated and quite high.
We're going to be able to follow these in particular in the first say five to seven days of the public admittance into the hospital and we hope to be able to see an impact down regulation there as we see in a fairly consistently get our animal models, so our expectations between those clinical endpoints and.
As inflammatory Biomarkers are these would be perhaps the most important signs of activity of our drug.
There are other things in our protocol.
Todd that we're looking at and I'll outline that really once we.
Once we don't some patients, but there are things that you see looking at ordinal skills around the disease severity. There's a there's a W.H.O. ordinal scale, that's being used quite a bit in a number these trials, we're looking into that.
Then there is others things for example time to recovery.
Avoidance of mechanical ventilation things of that nature. These these will be the exploratory endpoints.
Oh, great content all my other question I haven't these are pretty sick patients.
Theory yeah.
You know either the logos with high dose arm, you're seeing I'm, just trying to see benefit fairly quickly. Yes is there some procedure by which.
Yes, it can move very quickly to phase two I mean, I know that you're in vaccine trials and various unit or I'm guessing here you have fortys lack larger trials commands almost while the previous trials going on is there any set sort of set up with your trial whereby you see.
Good affects only on making progress to a larger trials fairly quickly.
Absolutely I mean, these are kind of unprecedented times and even from a regulatory point of view you see things moving very very quickly what we're going to be.
And what we were asked to do an IDE trial is to have a independent DSMB b.
Quickly look at risk benefit.
So even with 30 patients.
We're going to be monitoring these patients very closely.
You see a number trials and opportunities progress rather quickly was really small signs of activity.
I think that's that's because this is such a.
But you know unprecedented as I said public health crisis. So we are going to have the opportunity to very quickly.
Evaluate risk benefit.
Even before we get to 30 patients independent group will look at that.
Absolutely I think if there are signs of activity. We would we would work closely with the regulators here, what they have to say and the impression that we get right now is.
Patients are improving even small numbers of patients we have seen examples.
Over the last six to eight weeks of a very quick acceleration into advancing advancing these trials.
Great. That's very helpful. And then just going to pulmonary sarcoidosis trials on just.
It makes sense, we're hearing from water companies that there have been some.
Slowdowns in clinical trials.
And do you have to use put our guidance in terms of the trials are hit. Some you know these piece I guess you could call than bumps.
Could you kind of just walk us through what is your thinking in terms all how about patient data for the patients discontinued could be made up meaning that you just have to recruit.
Sort of brand new patients to make that offer I think you'd mentioned you'd have larger number patients and then also what are the sort of the critical you know rate limiting step second key keep the the phase one two being.
Finish, let's say before the end of year.
Is there anything that could be really you know rate limiting other than just complete locked down so going on I'm, just any thoughts there and thank you for all the questions sure sure.
Yes, so I think overall compared to maybe you know oncology trials.
Certainly compared to how kelcy job, we've done we've done pretty well.
I think some of that had to do with where we were we you know sort of just kicked off core three so we were able to sort of hit pause and we're hopeful to get most of those patients.
Back.
Ups in screening and re recruited a once once these sites go lives. So we had a healthy Q a patient and our expectation is we were going to finish enrollment.
Towards the end of March there.
So once you restart.
We're hopeful that we can we can move quickly.
Completing that cohort in completing the study when we look at some of the patients who missed doses.
Yes, the FDA has issued guidance, saying.
Look we understand that there are going to be potentially some holes here in there and the data.
But because we've had some significant interest in enrolling coordthree. Our thought is we maybe able to replenish if you will a couple of those patients that we maybe worried about.
You know how robust their data is with the ability to evaluate the data.
So there could be a handful of patients maybe two or three patients.
We would consider as I said replenishing into that cohort, we have the ability in our protocol to do this but it is something that are currently a number of sites.
You know, we're speaking to and we have the opportunity to do that so I would not be surprised if we overenrolled here and it's in essence some of those patients could then.
As I said be directed and randomized into our core to population.
Thereby giving us a nice evaluable population of 36 patients as we originally intended.
What could be rate limiting aside from just this overall macro the macro environment here with with Coca 19.
It's really how quickly we can get restarted and get those patients as I said.
Fit finalizing that cohort, but we were on track to.
Basically wrapping up a little over the course of that March if we start in June.
Hopefully it can it can go right back to that same rate of screening recruitment enrollment, but there is always there is always going to be that as a potential rate limit or.
As you know this this is something that it's hard to predict so the first step is to really get everything open very happy that a lot of the sites have already message to us that there's an expectation in late may early June to get back start get back back enrolling patients I think thats, great Thats, a great first step the second thing.
Is completing that enrollment once we complete complete that enrollment will have a better idea. If we can hit those timelines you described.
We'll provide more specific guidance on windows topline results will will come out from probably circuit also study.
Great. Thank you so much on Sunday I really appreciate the uptick.
Sure.
Your next question comes from the line of Zig Zag jumping from Roth Capital Partners. Your line is open.
Oh, Thanks includes when a customer sandal Cook one with regard to how many sites. We are hoping to have a loyalty club banking study and then can you just have a single site and then expand or did you want to get a couple of sites up and running firms.
Sure. Thanks for the question. So we've written currently up to 10 centers, Yeah honestly I think.
Our biggest challenge is not going over that I think theres been significant interest.
And to participate with our study so we want to of course enroll 30 patients and do it smartly.
There's no shortage of interest with the number sites here.
Our view is we're going to get started right away and open up sites kind of in and you know as they basically go online as they get I or be approval as we get the site initiation is going well go ahead and get started.
There's there's a as I said no shortage of interest here I think it's helped to the fact that we've already were in that many of these hospitals with our pulmonary sarcoidosis trial. It's helped that these are pulmonologists, who.
Really understand.
The potential utility of our drug I think they look at our drug as not re purpose as something that truly has demonstrated anti inflammatory effects in animal models. So all of these things that have sort of accelerated.
And keep us moving at a fast pace of getting.
Sites activated I think the biggest challenge here will be.
Trying trying to get.
Maybe under that number.
And maybe.
Some sites might get left out here and how quickly they can actually get started so.
I would I would stay team tune for you know a site to get activated animal nutrition and then we'll update the site list on things like Clin trials Dot Gov as more and more sites get activated here, but we could also very quickly see and we hope to see enrollment moved out a quick pace, where we may not get too.
Some of those sites that want to participate it's really it's really up to them with their local approvals and a.
Scientific review and higher be approvals at this point.
More than anything.
Hi, This is great and then just a quick follow up here our sites you activate it faster than they were pretty cool that I, just because of the senior assistant that or.
I think you nothing.
So so as far if you compare to say probably starting doses yeah, I think everything is moving faster I mean, whereas.
You know in a typical clinical trial, you might say head like to get and I'd be approval and they put you.
On the schedule for okay, you'll be able to schedule next month for our IR be meeting.
These hospital Arby's now our meeting several times, a week or as requests come in they may create an emergency meeting so depending on the scale of the crisis at their hospital, we're finding that.
These sites are moving faster.
I think right now.
It's very difficult times and things are moving at like speed.
Okay sounds like I'll get me thanks.
Sure. Thanks, So the question.
I'm showing no further questions at this time I would now like turn the conference after back to Dr. Sundays So class.
Great well. Thank thank you today for everyone for joining the good questions here.
Yeah, obviously, it's been a very very productive start to the year for us the pace at which.
It's really a.
Quick quite amazing at this point I think how quickly things.
I have moved.
We want to stress at.
I want to keep everyone safe hope your family's everyone's stay safe in this current crisis.
And we look forward to getting back to you in the near future.
Hi, everyone.
Ladies and gentlemen, this concludes today's conference call. Thank you for participating you may now disconnect.
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