Q2 2020 Savara Inc Earnings Call
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Welcome to the Civil <unk> Conference call at this time, all participants are in listen only mode and audio webcast of this call will be available on the Investor section of servers web site at Ciber pharma Dotcom. This call is subject to copyright and just the property of severe or recordings reproduction or transmission of this.
This call without the expressed written consent of severity is strictly prohibited as a reminder, today's call is being recorded I would now like to turn the phone over two and Ericsson head of Investor Relations in corporate communications at Cyvera.
Good afternoon, and thanks for joining us today, approximately supporting our second quarter 2020 financial result.
Good day.
2020.
Can be found on the Investor section of our website at <unk> pharma Dot com.
No, that's really where you'd like.
Ladies distribution list. Please email me and I are at some of our Afirma Dot com.
Call is being webcast live and one hour after the call a replay will be available on the company's website and will remain available for the next 30 day.
Telephone replay will be available through August 13th.
Today's conference call I'm webcast contain forward looking statement within the meaning of the federal securities laws, including statements regarding the company's strategy will product candidates clinical studies and financing better.
Such statements are subject to significant risks and uncertainties, including those described in our press release issued today Thursday August 2020, and our recent FDIC filings on form 8-K, 10-K and 10-Q.
Results or performance may differ materially from the expectation indicated by are forward looking statements due to those risks and uncertainty.
We caution you not to place undue reliance on any of the forward looking statements, which speak only as of today.
We'll take analysts' questions at the end of the call. However, we incurred shareholders to submit questions by email to IR at the bar up on a dotcom.
Permitting we will address this question alongside any others received by our IR team.
Joining me on the call today are brought have all chief Executive Officer drill Chowdhry, Chief Medical Officer, NALEO, a kind <unk>, President and Chief business Officer, and Dave Roberts Chief Finance.
<unk> Chief Financial Officer, I'll, now turn the call over to Rob.
Thank you and and good afternoon everybody.
Let me start by saying that I'm sure you <unk> progress, we're making across all hop on.
Most notably.
Program oversight.
We now have pharma losses on the phase three so call it two clinical study.
In a few minutes accrual walking through all the details because every share clinical team has been working diligently to get operational aspects of the study in place and our laws.
So that we can get the study up and running as soon as possible.
One component of that work is taking prudent proactive steps.
Determine how from Cowen group the study as best we care.
While we hope it won't be no major disruptions from the bars.
We are putting proactive measures in place to preserve the continuity of the study should any geographies experience a resurgence.
It was a such measures include tele medicine or at home visits where possible.
Separately, our manufacturing and drugs apart from all the truth is progressing as planned.
No discernible impact barcode.
On the topic of Cohen, you may recall in March we announced that do practical limitations course, balibar, we stopped enrolling patients in the phase three availed study.
The exploratory phone call startup.
Fortunately.
Well to keep the majority of enrolled patients in both.
That's true close collaboration with the research centers studies continue.
Regarding available enrollment numbers was smaller than originally expected with 133 enrolled.
We're talking to 150 into primary analysis population and that's been younger patients between six and 21 years old.
The older patient population completed 55 out of the top 50.
Well I'm rolling fewer patients than expected in a hurry population they will be a reduction in this call.
Additionally, as we near the end of the study and thinking about the addressable most of them off and we have to consider the impact of truck have to sit here in your proved to see NPL emerging data that has been transformative in the trees minutes yet.
Well it is possible an area that couldn't be effective when added to treatment with truck after that.
The avail study does not assessment combination.
Regardless, we remain optimistic the durbin make quite important role in the treatment of lesser infections by addressing the needs of specific patients within this year community I.
And we look forward to announcing top line results will be available study.
Early 2021.
With regard to I'm cool that study was about 50% enrolled with 14 patients out of a tall city right enrollment was halted.
As a reminder, encore is an open label North controlled 48 weeks exploratory study.
I do anymore predicts for the treatment of north to become a smoker vegetarian NTM lung infections.
Yes.
On his conclusion, we will determine next steps will be into an program.
Also includes exploratory Optima study north skin infections for which we announced topline results in March.
Gasunie, let's turn to our newest development program.
Those if you're not familiar they pull my cousin unhealthy for foster son.
For the treatment or non CF, probably yes.
Our team is sort of analyzing the data from the previous studies and that is always the free and older fall.
And working closely with <unk> key opinion leaders worldwide.
On the design of a confirmatory program for future discussion with yesterday.
After internal deliberations and discussions with the agency, we will have a better sense often this necessary resources to influence a pullback in the U.S.
Options for financing assays treated confirmatory program in crude offering to various forms of project financing.
With three phase three programs and I'll talk on the remainder of Twentytwenty will be a very busy time operation.
And importantly, your confidence about often didn't execute as we believe we're sufficiency resourced through topline results over the Vale and Paul that too.
With that of course, the quota of its a bit drool cutting more about how Congress impala too.
Thank you Rob.
And collaboratively.
Last call can eat out like NEXMET. Good design of the company make late in pilot PK study for late in the discussions but after.
No. Thank you have to be they're working to some additional details on Friday.
That's what it's done.
I'd now like a protocol that incorporate titration trend after yes and yes.
Neil in promotion that's called.
Bad debt is quite a lot to study.
Sample size, maybe 160 patients.
And do you expect to stop the study.
And of course squadron of 20 to 21.
Which would be a double blind placebo controlled study you typically endpoints.
Thank you Victoria, who have the primary endpoint license.
Well they did it just real quickly PVH, we've been talking directly to.
Okay. Good ability of trip I guess like I said, though.
Long can take jumped the gun interest in 10 gigabit Greens Creek clinically.
There should be the randomized in one of two arms.
<unk> 200 micrograms administered once daily Opex table this drug that's coming.
At the end of the personal computer you bought could think arms control over into that 48 can be open label called <unk> pediatric.
Each location because she made their pets.
Michael jobs admits drug lucky.
Why Lucky quest instead of looking at taking.
You can you just follow up period within Kurdish patient enrollment of the topic insect control patients to participate and just I.
Additionally, it's it provides useful information on the like upstream of the crop.
The primary endpoint of the public in study they do the lung function test of computing capacity for carbon monoxide or do you feel.
He hit them to pinpoint designed to measure direct patient benefit could they be Dominic.
There's been some digestion. It's tricky question I, just yet you totaled school.
Yes, you're right you actually took off that I'm school.
And if you sense capacity using their trust me.
It's a sample size, all 160 patients and probably not true is 90% powered to show that difference or 5.7, that's simply because of group and can be Unseal Act weekend to cool, which would drive it gives people that's change from baseline.
Pumping Pablo good study because it goes to get a winning study like after year end yesterday.
Statistical thing on the plane, but at any point well you I feel it could be supporting evidence I'll take a different across multiple clinically meaningful endpoints.
While the statistical then underfunded and place is not required.
I'm trying to drill DAPL across secondary let's take the endpoints would be considered websites.
Let me know compared to some key elements of the Impella. Two study it gets lost in bottoms study completed in June.
Oh 29.
Oh.
The primary endpoint.
That's the big is gastric situation.
The LTL impart lucky.
Hey, good luck in Paul.
You don't see over the second determination in the pilot study and showed a nice separation.
Between the once daily dosing regimen, I guess people.
But the truth and definitely helps 7.8, but to put it took improvement Oh God over placebo Act differently.
In the public to study the associated the neighborhood you know standardized testing this issue and all gift inside the used to say the Q.
Sure, Okay, and then Palestine.
No you expect to have that's about the ability in the deal to your dog.
You selected deal feel little bit exactly that's the primary endpoint impala too little bit I kept reasons.
They need because a standardized lung function test is widely used to digital package.
And then kick in the nation might.
The deals field test, it's definitely true that exaggerating, but.
Both can be repeated like more time points.
Additionally, they promised Jackie.
The difference between <unk> and the people more consistent yep Yep.
Okay.
Given this time, but that's 52 million pilot to you believe you can improve on the deals you have it sounds.
Hey, good yet it's stupid they shouldn't even part lucky.
Our lives as an exploratory endpoint.
I would like us knowledge, but the use of supplemental oxygen did it also buckets measurement will depend upon big factor and in part about study.
That impacted but it had been calculation.
Dan Palmer study protocol allow patients to the name of supplemental oxygen Julie Okay, that's something that could not this weekend.
Thank you Paula to address those the use of oxygen the compounding factor.
Specified that patients wouldn't need <unk>, oh supplemental oxygen.
And the trusted pulse oximetry to make sure boxes, you mentioned, it's still the night before either got fixtures measurement.
Judicious must be able to come up for connect locks isn't.
We've been Lucky Queen Doug I believe that situation.
And do station and DAPL situations, but nothing.
It's still being could come true yet, but in a show like in getting patients can come off something I'd love to Jim.
A shutdown period.
Although it's possible, but getting to study the patients because it's good programs.
We ended the placebo arm.
And the patient loved able to come up something like Luchsinger cut a short time PDH at lake to take place.
Well, let's review the secondary endpoints.
She out you love used it in Paula.
And as American before maybe used it in public too small.
Yes, yes, you have to complement.
Justin comes.
Activity that impact.
Sure I could talk in school.
Which brings the tip of the import going in PAMA too.
Right all to comp.
Yes, you could go to school boards are key secondary endpoint. The then Paul.
No go straight good nice separation between the once daily dosing regimen and keep them.
But in palette to.
Perfect. Okay got you activity.
Another secondary endpoint.
Because most applicable to get back.
And the Delta show nice separation they didn't Paul.
As a national function.
In Pollo to study India's that's it that's capacity using a credible test as a secondary endpoint.
The Troponin test is a standardized test, but the termites improvement in exercise capacity will gradually increase into speed explore the treadmill until depression distressed.
In contrast, Impala study used six minute walk distance or the keeps up into the endpoint.
Showed in the medical trend.
Hi, good wasn't let's go ahead.
It's a first had been test is expected to be discriminatory because patients outstretched today, thanks for that capacity.
Colon lung doboj isn't important aspect.
People don't forget that patients.
The first Impala study may should hold on nobody has a key secondary endpoint.
Both of these are patients who had one level about <unk>.
<unk> Impala, what slow at about 10%.
The Impella two study they didn't get caught a little dibadj, that's an exploratory endpoint.
But before do you have to be double blind to competed in palm a true you expect to have motivation I'm going to hold on the bugs to compare between mobile.
And placebo.
He promised to win how the total 160 patients into treatment arms <unk> 80 patients in each.
In contrast.
I mean Pollo study had to talk to all one time to play the integration.
Pre treatment arms.
It's about 48 patients in each.
Based upon the two study.
Only have one active keep telecom.
A once daily dosing regimen.
Calls and promise to be sure, but country picked up like the once daily dosing regimen compared to the internally can you repeat dosing regimen.
Operationally impella two the conducted its approximately 50 sites across the under 15 countries, including the U.S.
Canada, Japan, South Korea like select countries a deal.
We plan to trying to opening all 10 different goes that's close together that's possible.
In contrast.
In parliaments conducted at 32 sites across 18 countries.
<unk>.
But its interest but not activated at once.
Consequently, patient enrollment ramped up gradually over time.
Once all Impala citizen gets what opened.
Including like the use of us actually added maker.
He can go Medicaid, but approximately eight to 10 patients per month.
You bet that you plan to try and opening Oh Impala to study sites around the same time.
20 off which moved into your what's in Canada.
Because it really like Steve young and relationships with many of the Central is conducted being promise can you believe you come and go Impala too good good <unk> efficiency.
Even loved the guy do today on the timing and Goldman completion.
Once all the centers have initiated that's talking to treating they didn't feel Medicaid position lots of questions just your dog.
Yeah, No approved competing projects for airport in any country, not all but any company clinical trials.
Which is favorable putting policy the coupon.
Additionally, you have stopping the Impala ex study.
The continued I should have been Palestine.
We had approximately 60 patients are treated mother cooks 300, buckling down on intermittent weekly regimen.
Some patients come in politics.
Maybe eligible for being public to study.
Over the last few months, we have had productive conversations with regulators and they give us and deal up.
Just kind of related but in palm most of the design.
That's the odd comforting thing.
Oh stuck in discussions with the Japanese live in the kept on going I'm going to keep you updated on multiple did overlapping in this regard.
I think anybody box and one dimension.
Exactly we're pleased to see that this rare disease, it's in the mining of the if d. as well.
Agency in partnership with that that population.
As a national otherwise mission for rare disorders.
Firstly hosted a patient listening session focused Uh huh.
These sessions I mean, if so what agency to engage directly to patients all get audible gauge warmed up and just like to know what did you had disease.
And can you called that information from this session into deposition.
Patients.
At the Holocaust, a lotta research.
And you got happy to hear people living that Pat could shed the pockets story, it's been given I guess.
Because those stories.
But continuity well Oh Guy to proceed loan buckets for the treatment of this figure of cousins.
Thank you for your time today.
I Love handover the call today, who will provide you with up I got some uptick.
Thanks to drill Hello, everyone.
Let me begin by updating you on our cash position.
As of June Thirtyth 2020, we had cash cash equivalents, a short term investments of approximately 100 million were 25 million of debt.
Under our current operating plan, including the anticipated second tranche of approximately 46 million from our December financing. We believe we have sufficient capital to fund our planned operations.
With respect for a second quarter result, so far as net loss attributable to common stockholders for the three months ended June Thirtyth, 20, 29.4 million or 16 cents per share compared with a net loss of 21.9 million or 57 cents per share for the three months ended June Thirtyth 2090.
Research and development expenses decreased by 4.4 million for 42% to 6.1 million for the three months ended June Thirtyth 2020.
Compared to 10.5 name for the three months ended June Thirtyth 2019.
The decrease was primarily related to 2.8 and lower avail study costs due to the ramp up of enrollment the transition to processing the last patient out along with database management unlock and a reduction in related CMC and critical operations activities.
Additionally, there was a decrease of approximately one point sixmillion associated with them over to X Ray Pat program that study activities associated with Intel and Impella acts are wrapping up and we're now preparing for the initiation of Impella two.
General and administrative expenses decreased by 1.1 million were 26% to 3.1 man for the three months ended June Thirtyth 2025.
For 4.2 million for the three months ended June Thirtyth 29 team.
This decrease was mainly due to reduced commercial activities for the three months ended June Thirtyth 2020.
I'll conclude my remarks by reiterating that our cash position enabled us to execute upon our strategy I continue to work on our study initiatives now I'll hand, the call back to Rob.
Thank you Dave.
Before we close the call today I wonder share my fears yeah, that's a huge.
Especially as it relates to write that program and maybe just a telling him a few reasons why.
First the FDA has prompted breakthrough therapy designation lower density.
In addition.
It doesn't actually for the drug and they have is well understood.
And the data funniest part that's part of studies demonstrate the drug has a beneficial effect.
We are in great position with his partner.
But even lower that's okay, well patients and the investors not Bain capital tell us they also that even it accordingly on you see about the rule.
Yes, good division responsible for overseeing such therapies for some reason.
But the ability to apply key learnings from called up to the in policy protocol and offer incorporating input from yesterday and DNA into the study design.
We believe upon she has a high likelihood of success.
I strongly positioned to improve on Pos and exceed expectations in the future.
We are grateful for their loyalty and the patient support of our current investors.
Given what we have to call it too.
Drop in the city to work in the study that's about stops and not to you didn't mention on the factory Aha around US we feel this embark investment thesis is strong and poised to grow strong still.
As always we thank you for your support.
Got 40, keeping you updated as milestones are met.
On that no I'm not going forward that won't be transitioning away from 44 cents.
And instead.
Hosting where costs costs throughout the yet as needed.
And with the frequency that at the mine values.
Okay do you continue to disclose our quarterly updates for a press release.
Isn't that cheat and <unk> costs for Washington at Pos So that you can plan accordingly.
So I'll now Australians are cool analysts' questions.
Thank you well now begin the question and answer session to ask your question you May Press Star then one on your Touchtone phone pretty easily speakerphone. Please pick up your hand said before pricing the keys to withdraw your question. Please press Star then too.
First question is from Michael Higgins from Latin America Feldman. Please go ahead.
Good afternoon, guys as Edward on for Michael I. Appreciate you taking the questions when congrats on finalizing the design from Pollo too.
I guess a couple of questions on the design I'm wondering you were talking about 20 sites are being up in the U.S. in Canada I heard that correctly. So just wondering how many you expect to be spread through the you in Asia and then in terms of the timing for releasing of the data or the data itself Im just wondering whether the email.
The FDA will require a the full 24 week as a full 40 week data before you're allowed to start putting together something like in India.
Oh.
Hi, it's in the U.S. and kinda wouldn't be a 20 approximately.
The pool on both sides.
It was approximately 50.
And the spread they're going to have.
Hey, Tonight countries and got you.
Uh huh.
Also some sites in Japan and Korea.
It'll be more or less event.
The cost, but you add.
Pardon Kornya 'cause picky global scale dark site.
I summarize the 24 weeks, what's is 48 weeks for the submission.
In application to back to your the young man.
The 48 weeks.
Is the placebo controlled trial period, so the submission didn't happen.
He dog or the 48 weeks Dr.
Okay. Thank you for clarifying and in terms of the or they pull Nick asset.
I'm wondering if when you anticipate having is empty discussions and whether they'd be impacted by Cobain and do you anticipate running this trial in tandem with Impala to Oh would you prefer to wait until you get that data coming in.
Well, let me on that one this is rob.
Good question. So we you know we haven't gotten yet our internal goal is to have those discussions with the I cannot comment yes.
Reasonable hopefully this yeah, it's not and next year and then as far as running study in parallel yes. We believe me we won't do those how are the ones that study is often a study design set.
And we've done I mean, Tom Fanning from a.
Any cooperation standpoint, I think will most likely.
Okay perfect I appreciate all the detail thanks, and congrats again.
Thanks, good questions.
Again, if you have a question. Please press Star then one.
There are no more questions in the queue I will now.
In the call over two and Ericsson to read any questions submitted through email.
Thanks, We've got one question [laughter] one concern at the part with the positive impact on the Bosh had on that I.
Great.
Is that also the case with deal yeah.
I'm going through a lot to take this question.
We expect that ball contracts.
It's still benefit that bashing, even after undergoing a whole lot of fraud.
Okay, but you're not believe that colon lung much improved gas trostle.
Such an effect was not shown in the buyback study.
Well have to do stupid 11 of disease severity of the patients in gold.
You will enroll patients going in pilot to the similar dismissive attitude.
As was and in partner.
And in pilot there wasn't noted improvement going it got fixtures are currently hold labite, how but the improvement what's my limited direction.
And the patient disease progressed.
We don't anticipate that to change any problem I too.
Thank you Jay said are there any other.
Yeah.
No there are no more questions in the Q.
Okay. Thank you. Thank you Jason thank everybody for taking the time startup appreciate it.
Okay.
The conference has now concluded.
Thank you for attending today's presentation you may now disconnect.
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