Q3 2020 Galmed Pharmaceuticals Ltd Earnings Call
Good day and welcome to the Delmed conference call to discuss financial results for the third quarter of 2020.
Today's conference is being recorded.
Before we begin please note that we will be making certain forward looking statements on today's call, including those regarding financial results statements and forecasts regarding anticipated timelines and expectations with respect to our regulatory and clinical development programs as well.
Other statements that relate to future events.
These statements are based on the beliefs and expectations of management as of today and actual results trend.
Timelines and projections relating to our financial position and projected development programs and pipeline could differ materially.
It'd be.
Killers [noise].
There is significant uncertainty about the duration and severity of the COVID-19 pandemic and its impact on government business in operations.
We urge all investors to read carefully the risks and uncertainties disclosed in our filings with the FCC and including without limitation the risks under the head.
Heading risk factors described in our annual report on form 20 Dash F filed with the FCC and the risks and uncertainties include it in the form six dash K filed with the FCC earlier today.
Delmed assumes no obligation to update any forward looking statements or information, which speak as.
As of their respective dates only.
I would now like to turn the call over to Allen Baharaff, President and Chief Executive Officer. Alan. Please go ahead.
Thank you Christine.
Good morning, and thank you for joining us on today's conference call.
I'm pleased to be here today without.
She spent difficulty sir.
Indeed, our chief Financial Officer, I should answer it.
Provide you with an update on our clinical development programs as well as reported to you on our financial results for the third quarter of 2020.
As always we wouldn't be happy to take any questions you may have.
At the conclusion of our prepared remarks.
I'd also like to say that I hope you and your family our Safend wells as we work to overcome the COVID-19 outbreak.
The news in the past week regarding the progress on the size of vaccine has been particularly encouraging and we look forward to putting this all behind us.
As our business report this quarter is going to be relatively short however, they're expecting to be able to report next month first in human PK data from our RM coal Methylamine program.
Earlier this quarter, we announced that we entered into a research agreement John ex Pharma holdings.
Point Company office Lettuce pharma ended developing combination therapy of S.C. 41 in oral thyroid hormone receptor beta agonist and our encore.
By combining a C 41, with its rapid reduction of liver fat and improves blood lipietz profile.
With our coal that showed improvement in like Cameco index and fibrosis, we believe position, we'll have a good solid additional tools in the toolbox.
Earlier this week, we announced a collaboration with my Biotics, an Israeli based company that develops microbiome based product and.
Mmm, restoring microbiome equolibrium for the therapeutics and food markets.
This collaboration is part of our overall plan to maximize our encore clinical efficacy.
This builds on our work to date, which includes dosage optimizations 300 milligram I'd resulted in higher.
Boudreau Aramchol by 53% product optimization development of Oracle Mega mine with higher scalability, and lower variability and treatment duration optimization.
Microbiome is known to be a major driver of Nash and fibrosis and offer great promise as new approach to treaty.
Challenging disease.
A growing interest following the recent positive topline data from the SCR, one or nine phase three study suggests that microbiome as a novel drug modality, both as a monotherapy and in combination with our of course.
The collaboration also aims to identify.
Hi specific microbial biomarkers for Aram coal based on microbiome data collected from government clinical studies that could.
Serve as a biomarker for arm coal at an early stage of treatment.
Now, let me turn to update you on the are more phase three study.
We have lifted some of the constraints.
For us in states identified as Green states, allowing individual investigators to determine whether it is safe to resume screening activities and recruitment and we have opened sites in 10 additional countries, including Korea, Turkey, Belgium, France, Spain, Canada, Mexico, Chile.
In Australia and the UK.
However.
Rapid ongoing spread of the COVID-19 pandemic as well as the second wave in multiple countries has prevented activation of many of these sites. Moreover, many of the sites have been activated.
That has been activated if.
Halted elective clinical activity due to local restrictions.
We're in the process of developing a new recruitment plans and this precludes us at this stage from providing an update timelines for completion of enrollment and topline results.
To align our budget and burn rate with the new recruitment focused well.
We are working together with our partners in the execution of the hour more phase three study to significantly cut our expenses inside them as much as possible to enroll patients activities.
We are continuously assessing the situation and expect to provide additional information by mid December.
Before I can.
Our vote virtual analyst day has been now shed dual for January 26 in order to allow the presentation of clinical data from our more mature mine and mill five mirror clinical programs sales.
Save the date notices in contact heaters would be communicated by lifestyle devices.
I would now like to turn the call over to high potential our Chief Financial Officer to review our financial results for the third quarter of Twentytwenty two high end.
You Alan and good morning, everyone.
This morning, I will be providing you with our financial results for the third quarter ended September Thirtyth 2020.
Our loan formation phase the first product both on form 6K filed earlier today with the SEC, which among other things provides a summary of such financial results.
For the third quarter two for the third quarter of 2020, our net loss totaled $6.9 million or 32 cents per share compared.
With a net loss of $4.5 million or.
21 cents per share for the corresponding quarter in 2019.
Research and development expenses totaled $6.5 billion for the third quarter of 2012 is compared with 4.1 million for the third quarter and 2019.
The increase resulted primarily from the increase in the clinical trial expenses in connection with our.
Ongoing almost trial.
Turning now to Genie, our general and administrative expenses for the quarter totaled $1.1 million compared with $1 million for the corresponding period in 2019.
Increases other family from an increase in the cost of R&D and our insurance policy premium.
During the three months ended.
At September Thirtyth 2020, we had a net financial income of zero point $7 million.
0.5 million in the third quarter of 2019.
The increase primarily relates to the realization of unrealized gains from prior periods.
Our cash balance as of September Thirtyth 2020, which.
Which includes.
Cash cash equivalents restricted shares short term deposits and marketable securities totaled 58.7 million.
Third with 75.6 million in December 31st 2018.
With that said operator, please provide instructions for the Q and a portion of our call.
Okay, we will.
I'll now be conducting a question and answer session.
I would like to ask a question. Please press star one on your telephone keypad.
Confirmation Tom will indicate your line is in the question queue.
You May press Star two if you would like to remove your question. Thank you.
The participants using speaker equipment, it may be necessary to pick up your handset before pressing the star keys.
One moment, please while we poll for questions.
Thanks.
Thank you. Our first question comes from the line of Steve Ceos with Raymond James. Please proceed with your question.
Great. Thanks, very much I was hoping you could just elaborate on the John Rex TR beta.
Either that Youve licensed maybe just comment on the selectivity in the fall.
Potency of that molecule for TR beta and also selectivity for.
The liver because just to compare contrast, it with the other clinical stage TR beta.
Thank you. Thank you, Steve so sort of force.
We are not at Liberty.
To disclose any information from ongoing studies.
By Flexi, so by Janet Janet.
So it is a public company, but I will let Liam maybe talk a little bit about the specificity and it would I guess what you also.
So we would like to know is differentiation from Madrigal steroids.
So we are please go ahead. Thank you. Thank you Steve.
You know and we sell the pharmacokinetic data and the binding athleta facilities and.
Yes.
Assay 41.
It is more specific.
And should be an actually can be given in a much lower metals.
We chose much higher specificity, we are currently tracking that.
Yes.
Of these compounds standalone together with ample standalone.
And the combination in order to compare in in vivo studies.
The rationale for the scientific rationale for the combination is quite clear.
We do notice that this compound.
Can reduce leverage.
Why.
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Quite fast.
Sales and should have a massive.
In fact on not only the fat.
If we are talking about one to 10 those are.
Of Madrigal MTL.
The 196.
Talking about.
Much more specific.
Yet we know that they have a very good liberty oppose this data.
And we do know that.
Coal will have very good liver fibrosis data as a national solution and fibrosis improvement.
That being said.
Together, it will give us much better industrial solution and fibrosis improvement.
And it has a very good safety profile.
We've seen so far.
It has a very good safety since it's a as I said.
So it has that it can be given as one to 10.
Does have.
Luckily guys compound though.
We will have less.
The issues.
Very good efficacy and places where our encore is going to be combined.
With.
Okay. Okay. Thank you and then the other.
The question I just had was.
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Oh, and you mentioned, there's a lot of moving parts, obviously geographically.
Our study.
There's a lot still left to play out with the pandemic, but I was hoping I think heading into the study.
I had some idea of how the enrollment would split between you ask Europe, I think South America, and Israel at least and I was wondering if you already sort of had some sense of if that.
Geographic distribution of enrollment than you had originally anticipated will will in fact.
Play out differently.
Or if it's kind of still too early to tell given all the moving parts.
So it is it is unfortunately too early to say we are still just as a reminder, we were talking about between 40% to 50% of patients coming from the U.S., 35% coming from Europe, and 10% coming.
From the Middle East and the rest coming from Latin America, and the rest of the World Korea, and the rest of Asia, Australia et cetera.
Unfortunately, the two main agents of the study.
Which is the us and Europe.
Have slowed down significantly.
Over the last quarter I was hoping we've seen.
June July there was a pickup but then.
Then with the second wave.
It kind of slowed down again.
So this is why we ask the both.
Our internal clinical team and together with our COO.
Two seats talk to the investigators one by one understand what is.
The capacity what have changed into hospitals into clinics in the countries.
There is some countries like Australia, which are doing very well because there is no I mean koby disease is quite contained.
Korea is doing well, but.
All in all those countries are capped I need the two big engines to act and unfortunately, they are slowing down so we need to see how we compensate we have good news coming from Brazil, we weren't expecting Brazil to come into play so.
So early in the game.
And.
What I've been hearing from our regulatory people is that we.
We may be able to start and recruit patients already in January in Brazil. This is good news because.
Studies.
And tell you that.
As far as I know only the two bureau today.
Allegan study was.
Recruiting in.
In Brazil, Genfit and intercept we're not going to recruit because of regulatory issues. We've passed these hurdles and.
And I hope that they can contribute.
Many patients to the trial, but again.
We'll all have to bear in mind at the end of the day, 85% of the patient's needs to come from Europe and the us.
Got it appreciate the question thanks.
And just just to add up I mean, we are using as you know this.
This is not at a time, which is.
Lost because.
At the end of the day, we were planning to switch patients from two arm core measurement and ER. We are using this time to advance and this is why if you. If you recall from our previous guidance, we were not expecting to have clinical data from megalomania.
As early as this year, so we pushed.
These timelines of Oracle megalomania, and and I hope that that would bring good news and we'll certainly have also an impact on Oman the undefeated on the pivotal study.
Yes indeed.
Yes.
Great. Thank you. Thank you.
Our next question comes from the line of Christian clues go with Cantor Fitzgerald. Please proceed with your question.
Hi, everyone. Thanks for taking my questions and hope you're all doing well I wanted to ask about your recently announced.
An operation with my biotic, So maybe I can first take a step back here and ask you to.
You described your view on the role of the microbiome as it relates to Nash I know, we've seen a lot of evidence so far in 2020 about the potential of these medicines and biomarker work and.
General and then also as you look at the Nash space say five to 10 years down the line from now when we might potentially have some therapies on the market I wanted to ask if you think that this is successful whether tools like this could be used.
For precision medicine to try to identify potential responders.
From the very early stages.
Presidium currently artistic thank you. Okay. So thank you sustain for doing that I, just want to size I suppose everything and it's been kind of a perspective we.
There were multiple activities around encore in order to actually muck.
Customized its ability to treat Nash patients.
So as that overall plan that we elevated the exposure to because we have a better products now with the uncle nickel I mean, and we used a combination that I previously discussed with a tirade hormone receptor agonist as well as my but as well as the.
Combination that we are planning with my Biotics now that.
The science around the involvement of the.
Jim.
Microbiome and theology of NAFLD and Nash goes all the way back to.
2015 and onwards.
It is now emerging scientific evidence that it may be that cause.
Or at least I have to say a company caused to enhance this disease and patients that have different Michael biota is more prone to develop.
Novelty and Nash in more advanced publications are showing the specific microbiomes profile for fibrosis.
And so the I would say that the scientific eyes test or the attention. This is really ongoing and coding we.
We will.
We will actually looking for three main.
Outcomes of this.
Combination collaborations, yes, I mean, they're going to handle the brominated, an and collaboration it's true. So the first one is going to be at collaboration to induce and.
And to enhance the efficacy to 'em could take into consideration for example that we have responded to I'm confident we will be able to identify and see how the Michael I am also responded different from the non responders and then seek to change the Michael.
I know.
Of the non responders to the responders, one and by that enhance the efficacy of course, yes.
As a standalone therapy, Michael Blum and.
Change and the rights law can be a standalone potential therapy and of course, we.
As gold med looking for the combination of that Standalone together with that.
Mhm coal efficacy to create a better treatment.
To.
To a nash patients. So if you look at this as an overall plan we are looking at.
Nation to 'em call, they're looking at and.
Enhancement of our encore.
Jim.
Response rate and we are looking at is it.
Standalone therapy for Nash patients, but we are also looking now as the act.
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Michael Blum as the Biomarkers to their response to of course take into consideration that maybe three months. You can also see you can already see the change. So this is something that you can do in three months. For example, it gives you a good biomarker to the efficacy.
Of the compound.
And we have already incorporated Christine in our ongoing clinical studies.
Microbiomes ample so we're collecting samples.
We are collecting collecting samples of healthy volunteers of Nash patients treated oracle treated patients there is a lot of data that.
I would now we can provide that works together with my Biotics, which is a leading company in this space too.
To exert everything that early access through that yes.
After sales we are going to.
The multiple dosing of harmful nycomed the single doses.
On the way on this finalized the multiple dosing was started early as meet this and that and that Michael I am simply.
Samples is already implemented in the protocol multiple dosing of ampco mikkel domain as well so its Dave.
Turning to be in all our.
Studies onwards.
Okay, Great Yeah, and then just the second part of that question is you know as the evidence of the microbiome role in general is emerging and you know if you find in your experience that it is helping identify those patients and that combination.
Patients work do you think that down the line you know we can look at Nash is something where precision medicine can come to play to you know really see which therapies might have the most potential just from the gecko rather than you know starting patients on treatment acts and it doesn't work and moving them on to treatment why.
Definitely and it's all been it also will cause for personalized medicine as well I believe that in a in a time, where we will hopefully have multiple.
Medicine in the market so in the in the Nash space, Yes, definitely this is going to be a company.
Therapy for end also biomarker for ticket sales. So we look definitely add personalized medicine as well.
Great. Thanks, so much.
Thank you Christine.
As a reminder, if you would like to ask a question press star one on.
Telephone keypad.
Our next question comes from the line of Ed Arch with H.C. Wainwright. Please proceed with your question.
Hi, good morning, everyone. Thanks for taking my questions.
And thanks for the additional details on our more and other aspects.
So I recognize as you said in your prepared remarks, Alan that there are.
There is a new recruitment plan underway as you look at the various sites.
And.
Across the globe and the different.
Recruiting.
Rates of those my question is.
Perhaps this is just too early to say yet but.
You have current guidance for full enrollment by the end of next year.
Is is there a.
The chance of that.
It would be updated or revised when you get back to us.
Perhaps next month sometime on on more details around the plant.
So thank you Ed and we are all actually we are moving right away from this call for your conference. So all the leasing.
There is a llyod would be presenting goal would be with you on a.
On a five Chad.
In I think in 30 minutes or so.
What are your Israeli conference and thank you for inviting us to mainly.
Balls in the air I mean, and this is where we have to decide on the one hand.
We are we want to push and we are pushing as much as possible on recruitment.
Timelines for our more and specifically in countries, which are less affected by COVID-19, which is easier, but as I repeatedly said before us and Europe are key country.
Trees and.
And recruitment have slowed down significantly in this place is indeed I can tell you that.
Places like France.
UK, Spain.
No Jim Herbert I'm missing another one or two European countries.
We have not randomize the patient now for the last two months. So there is a very serious Ur COVID-19 second wave in these countries and I don't that Defitelio, what is going and what's going on in the us.
So we yes, we are pushing for.
Putting more adding more and more patients but at the same time, we have to take into consideration the switch to our incremental them in which we want to make a very efficient swiech and we know that are on call Mega domain is a better drug product at the end of the day, and we would like more and more of our patients.
To be able to enjoy our uncle megalomania for longer period. So we are really.
It's a kind of a.
Two conflicting.
Hey, it rolls in one had push as much as possible and recruitment on the other hand CD benefits for the patient.
Once and we try to balance between the two.
And we have a meeting with the regulator with the FDA and the European regulators to discuss this program and decide what is the best way in order to make that happen.
I hope that by December.
When we come with the data with the Mega domain and the new recruitment plan all of that will be revealed and you will have a very clear guidance. This guidance of timelines on.
Okay execution and catalyst.
In our mind everything is.
Crystal clear unfortunate.
Early if not the public information so we cannot disclose that at this pace at this stage.
Right.
That's fair enough. Thank you very much for that and that's it.
Great.
That's a great segue actually to my next question as you mentioned right at the beginning.
Your first in human PK data as expected from exiting next month as you mentioned so I'm wondering.
Given the sales.
Key to all your overall plan too.
To.
Move forward with the bio equivalents.
From the salt to medical imaging.
Will you be identifying the equivalent dose next month to two to 300.
Milligram be I'd have to salt is that part of what you're expecting to announce next month.
So Lee out would pick that said that this on this thing.
I think that those clients over design.
Well the end need.
Next month the next.
Measles this and Larry.
We will know the single dose exposure.
Unusually.
Let's put it this way the regulators sees.
I'd like Cleveland is.
I think it does in fact.
Patients and this is good enough.
Because I'm still has a long half life, we are waiting for two days and then start immediately selecting to sales for the multiple dosing which will end.
Hi.
And we will have data.
Hopefully by the end of January already we will know the multiple dosing and then we will have to go I mean, we go directly to the regulator to present the single dose to multiple dose just in between I can definitely tell you that while the laboratories are analyzing the.
The current asset mix I mean, we keep on with the food effect only to be in the sales right, there's not going to be anything that the regulators will ask or when we will not have to present. So we will actually sent to package and with a single dose multiple those in.
And.
Yes.
At that time, so single dose will have to provide us with some data that usually for the regulator is good enough. If the regulator is asking for 80% to 125%.
Moshe data so it's going to be good enough for us because of the long half life, we will give them already.
The mattresses dosing. So we will have a clue with regards to are we going to be able to go back to the cigarettes or not.
Im couldn't make you mean, we definitely know that we will be able to.
Reach higher exposure to lower it.
Who anyway be needed if it's going to be twice daily.
Or is it going to be a once daily then we will need.
Higher dose that once daily homogeneity, among patients who will be much better.
So we see much better productivity.
So.
In the mid West will publish the results of the syngas does.
With the higher equivalent we I mean, we we took two doses to 30, new men of sampling that can mean and we compared it to list the 300 milligram tablets.
Tablets that the.
Patients are actually receiving in our mall and will publish the result.
Great. Thanks Leah.
That's helpful. One final question then for me if I may.
Around this my Biotics.
Collaboration and combination.
Were announced on Monday.
You mentioned earlier.
One of one of the objectives are with these patients with the dis regulated microbiota is.
Two.
In hand.
The efficacy specifically of those non responders and I would imagine that.
The way that you do that is.
Exactly the biomarker that they've developed and so I'm wondering.
Tom if you could give us a bit more detail around how exactly.
And.
The company is able to to identify.
Potential risks.
Responders or or any help you to enhance the efficacy.
So imagine Ed that we are talking about.
The best way to character.
Hi, you have of patients you characterize his response by Nash resolution of fibrosis improvement. These are the regulatory endpoints the clinical trial and do you see that.
All the patients that you have it responds well to encore.
Has.
A very top 10, which is completely different from the non responders with Michael Hi, Omar I asked that then you know exactly what kind of Michael Hi, Michael I Am change is calling me Hello.
I'll respond.
But you are going to.
Two is either change the Michael biotech off the non responders to fit.
To that I'm going to respond as one and by that you push to respond to a hospital is even better through entities.
Got it Thats helpful. Thanks again.
Thank you at Q.
Thank you we have no further questions at this time Mr. Boris I would now like to turn the floor back over to you for closing comments.
So thank you all for joining gold cold today and I.
I do hope that.
We did.
You would follow our.
Press releases.
His own during December I see that.
There is a lot of exciting news that we are hopefully that we always start and releasing by December and January coming from both the encore Mclaughlin, but also I would like to remind you that the below five mineral pipeline product is also.
During the.
First in human study.
Early Q1, so hopefully by the analyst day of the 26th of January 26, we'll be able to communicate some data from this study as well.
Keep safe and thank you all for joining the call.
And.
Ladies and gentlemen, this does conclude today's teleconference. You may disconnect. Your lines at this time. Thank you for your participation and have a wonderful day.