Q1 2021 Galmed Pharmaceuticals Ltd Earnings Call
Good day and welcome to the Gal net conference call to discuss financial results for the first quarter 2021, 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 of regulatory and clinical development programs as.
As well as other statements that relate to future events.
These statements are based on the beliefs and expectations of management as of today and actual results trends timelines and projections relating to our financial position and projected development programs and pipeline could differ materially.
We urge all investors to read carefully the risks and uncertainties disclosed in our filings with the SEC, including without limitation the risks under the heading risk factors described in our most recent annual report on form 20-F filed with the SEC.
So all of that assumes no obligation to update any forward looking statements or information, which speaks as of their respective dates only.
I will now turn the call over to Al and Baccarat, President and Chief Executive Officer. Alan. Please go ahead.
Thank you Donna good.
Good morning, and thank you for joining us on today's conference call.
I'm pleased to be here today without chips and difficulty Sir hopefully up here the knee.
Our Chief Financial Officer, Vice Chancellor.
Provide you with an update on our clinical development programs.
And as well as with both of you one of our financial results from the first quarter of 2020 one.
As always we will be happy to take any questions. They may have and the conclusion of our prepared remarks.
And we had a week.
Our invested year and pulled the only a few weeks ago. My report to you. This time would be very short.
Starting with the globe with our global Phase three registration of all the most study and its.
As previously reported. The addition of the open label thought was approved in the U S, Canada, Australia, the U K, France, Belgium, and Spain, Israel GB and 30 and is expected to be approved in the coming weeks in Korea and Mexico.
Based on our plans and the rapid regulatory approvals I can reconfirm that results from approximately one third of the study population I E.
Subject.
Has completed the post baseline liver biopsy.
It will be available in Q4, 2020 one at the plant.
That being said in Q4, we expect to have results on the efficacy of <unk> with higher exposure and fibrosis and liver fat confirmed by the liver biopsy.
Also reported earlier this month.
The mall received and I and the approval in China.
We view the approval of the Dell Most study and China is a significant milestone in the development of our uncalled for Nash and fibrosis, which may accelerate the pace of randomization of Fei.
And to the double blind volatile for the almost study and also position. The arm core is one of the foremost therapeutic candidates for Nash and fibrosis and this large and the emerging markets.
We look forward rapidly initiating enrollment in China as soon as practical.
As previously reported almost double blind placebo controlled registration of the policy is expected to initiate by the end of Q1, 2020 two and he's ex.
And because it will be based on our own coal Mac and the mine, which is the sole form of our uncles of seed with an improved target product profile.
Earlier this month, we submitted to the FDA the result of all of them well.
All of the mine phase one study with specific product development plan this will enable them.
To replace all of them call. It the I D with the arm consoles Judy with the.
And the exposure.
Got me the perspective during Q3, the received guidance from the F D. A.
The loss to introduce our uncle and make the mine into the double blind placebo controlled registration of the part of the hour more phase III study.
Now shifting gear well apartment compound immuno five merit.
As a brief reminder of mellow five mirror ease of highly potent inhibitor of chronic inflammation currently under development for IBD with the targeted and specific mechanism of action.
The middle five mirror Downregulates multiple pro inflammatory cytokine secretion.
And preclinical studies and unified mirror demonstrated interference with the room ameliorate a.
Well, the amortization and aggregation, which is the ex any form of Cerro Moro and every day.
And graduated several of them relate a is the main cause and Gabon VAALCO chronic inflammation.
And the Euro five treatment resulted in significant reduction of clinical symptoms and pathological characteristics of the disease in multiple animal models.
And unified and there has the unique mode of action upstream all pro inflammatory cytokine production, which are currently being used in the clinical trials and in the clinical use.
Earlier this quarter, we announced the first dosing of the first in human Phase one clinical trial from unified mirror for single and multiple dosing.
I'm happy to report today, and we completed all single Administrated, though the starting from 10 milligrams up to 180 milligrams per.
Following excellent safety and proportion of TK, we decided to go one of those even higher and the 360 milligram is currently being dosed.
And the offline data is expected and the second half of 2021.
The phase one the proof of concept of study is planned for Q4, 2020, one and will include Biomarkers for efficacy such as reducing several of them and really day and the several months of patients and other inflammatory biomarkers such as C of O P et cetera.
And this phase one b study and below five and there will be administrated subcutaneously and orally for four weeks with additional four week safety follow up period.
We are currently developing a mill of five nearer and oral treatment for mild to moderate ulcerative colitis, however, and its mechanism of action is relevant to other chronic inflammatory diseases. We are also looking at additional indications and plan to develop the targeted formulation of accordingly.
Now, let me transfer the code the CFO of <unk>.
Yes.
Thank you Alan and good morning, and thanks for joining our call today.
This morning, and we'd be providing you with our financial results for the first quarter ended March 31st 2021.
More information for the Big day.
Sales of all of the pulse on form 6K filed yesterday.
Which among other things provide the summary of such financial of the call.
For the first quarter of 2021, our net loss totaled $8 $90 million of Stifel.
<unk> 38 per share.
Net sales of $6 1 million of 99 cents per share for the corresponding quarter of 2020.
Research and development expenses totaled seven point for me and for the first quarter of 2021.
Over the $5 6 million for the first quarter and 2020.
The increase resulted primarily from the increase in drug development expenses in connection with the manufacturing of our oncology line.
Turning now to G&A of general and administrative expenses of political quarter totaled $1 7 million sales of zero.
Zero from Nike and for the corresponding period in 2020.
During the quarter the waived the total of approximately 17 point for me and the net profit and an underwritten public offering and from our ATM equity facility.
And the results of the funds rate and our net loss and our cash balance as of March 31st 2021, which include the cash cash equivalents.
Cash and short term deposits and marketable securities both of $58 9 million.
And as compared with 51 million on December 31st with all of them in 'twenty.
With that said operator, please provide instructions for the Q&A portion of our call.
Okay.
Thank you the floor is now open for questions.
I would like to ask a question. Please press star one on your telephone keypad at the time of calling for.
Formation totally indicate your line is and the question queue.
The press Star two if he would like to remove your question from the queue.
For participants using speaker equipment, and it may be necessary to pick up your handset before pressing the star keys.
Once again that is star one to register a question at the time.
Our first question is coming from Stephen seed House of Raymond James. Please go ahead.
Great. Thank you can you just talk about what you're seeing and the single ascending dose study for the mill of fiber and you have and you're doubling the highest dose obviously the tested and the initial escalation just curious if thats based on PK alone or if that's based on some of the inflammatory.
Biomarker data that you indicated you're collecting.
Thank you, Steve and no.
And PK and safety and to the ability.
You have two of them back.
And then unifies mayor is sound regulation and so let me read the eight like litigation and plenty of innovation and the happens on time of inflammation and <unk>.
He went and tears.
And do not have hi per and production and and polymerization and the delegation of film and the 90 day. So there is no use in the looking into and downregulation of selling the middle East and which is not elevated and housekeeping and see them.
Got it perfect and then just regarding a Ram call Meglumine can you just clarify it.
Okay.
Type C meeting with FDA.
And the feedback you're expecting and subsequent to that or are you still planning on having a type C meeting or are you just the waiting.
Written feedback and the third quarter. Thank you.
We are waiting for the weeden.
We submitted the request for my team and I mean do.
Due to COVID-19 free.
And you can ask traveling to the Washington now.
And we are we fly and just put a neat thing and the al So our sense of the package and we expect the in June two has and we can response from the FDA and are fully planning.
<unk> got all of them.
The line studies results that we had because of with.
And with Courtland, and mcnamee and compared to and I'm calling effort.
But the FDA has confirmed the D. C has done under the type C.
Meeting.
Thanks, Kevin and when she's the better.
No mandatory timetable for a response.
And it makes sense, thanks, Alan and thanks, Matt.
Thank you.
I'm sorry, our next question is coming from Ed Arce of H C. Wainwright. Please go ahead.
Hello, everyone. This is Thomas Yip asking a couple of questions for at Ah. Congrats on the other progress made this quarter.
Just wondering of the histology data from the patients.
The study.
The breadth of fourth quarter of 2020 one.
How many patients will be F. One the.
And the rough.
Roughly how what's the percentage of patients that have been treated for 24 weeks or more.
And it works over a seven week period.
Okay. Thank you.
So.
The majority if not all patients are going to be ex too. If three these are patients reached at the <unk>.
Transition from.
The double blind part and as you know we are one and recruited.
Ex U S three patients for the double blind.
Art.
On top of my head we're talking about.
The 25 patients are going to be on the 48 and seven and do the two weeks.
And the histology.
And the biopsy time and.
About 25 would be on the 24 weeks.
Okay. Thanks for the additional.
For the study and.
And then for the new and it will be approved.
So the and China.
Well the dosing there.
The work of the new Aramco and Mac.
And the formulation.
<unk>.
No.
What are the I. Indeed, it was approved was the existing protocol I E. The protocol three of the almost study which is the twice daily.
Hence exposure of the 50% higher exposure. This is the data we will see also from the open label study.
We are the protocol for the open label study and this is now in process. We are now in the discussion on to approve these amendments from the hopeful amendment and protocol five he's going to be the Meglumine, which has to be first approved of course by the SBA.
And then we will amend the globally, including China. So, we're starting with our uncollected, but hopefully moving the.
Swiftly to arm core magnum in when the allowed all of the not only from China, but all over the world.
Okay sounds good the and perhaps one final question from the port for mineral fiber based.
It's one of these study.
And you go over the rationale of.
The core and a half with full subcutaneous and oral dosing.
And this first one day.
Yeah definitely.
<unk> and immuno science and there are in.
And two formulations, one and say the formulation and it's going to be a directed to the chassis colitis that means that it's going to be opened and assistance the H E.
The G I.
And then we do want to see and exposure of a subcutaneous use so we go with the both formulation into.
Thanks Wendy.
Yeah.
Yes.
Okay sounds good. Thank you so my question.
And that's kind of development will allow us to go to multiple indications because of some indication and it's already for instance require a net.
The opioids.
Injectable.
Administration, where others require local overall and like.
And you alluded for the GI tract, but we are working in parallel with the Duke was the two formulation.
Allow us to expand the development program to other indications once we start the first one we see as the one that we describe of course for IBD and tropical items.
I see yeah. So yeah. That's that's what the addition of our indications, but that the budgets that measure.
Exactly.
Okay. Thank.
And that gives so much and we look forward. Thank you.
Yes.
Thank you. Our next question is coming from Christian <unk> of Cantor Fitzgerald. Please go ahead.
Hi team this is Rick on for Kristen today.
The rats on the quarter and I just wanted to ask a couple of questions.
In light of the ongoing pandemic I wanted to ask about the team's confidence and being able to have a comprehensive datasets and the first 50 patients and the histology of result, the Ram call. You believe these results could tailor your inclusion exclusion criteria for re initiating the study by the end of first.
Order of 22.
So as our VP of clinical affairs.
Shai kind of just the return back from of treats and the U S. Visiting our U S sites.
Of our U S sites as you are.
You may recall, we've carefully selected out of the 215 sites, which are ex Steve in the almost study.
And the above 55 sites, which were less affected by COVID-19.
Israel, Fortunately I mean, so in terms of.
Working here from Israel.
Almost back to normal way of other problems, but has nothing to do with COVID-19.
But the Europe, we see some delays.
And we're not expecting any patients coming from Europe at that time and that in our forecast the majority of patients would come from the U S.
And we've selected areas in the U S sites of which were less affected by COVID-19 and.
Meeting with the.
Just recently.
We confirm the timelines and all of these all is going well and spend for the renegotiation of the double blind part of our more like Q1, 2020 two.
Understood. Thank you and maybe just one more given the complexity of the IBD market I know you kind of maybe alluded to this earlier, but is there are there is certainly a large and diverse patient population to serve.
Knowing the best segment of the market the target with the Milo five more of what's the.
Pacific signals are you looking for and the proof of concept data in order to better inform you know what kind of patient populations. The subset of the market and you would really targeting later trials.
Thanks for that and we are targeting a task of colitis patients mild to moderate.
Hum.
Yeah.
And safety.
And so the ability and secrecy.
And Matt will be superior as we see it now and in payment and motor the Teekay and that'll be it.
T in healthy volunteers.
And to all the other.
And of crime.
You said that are currently in the market you have to understand the all the price variable.
And even compounds and the market and.
They are.
Extreme the education.
The T is not so easy and the immune system is and pesticides not the same and the.
And these other compounds are.
The timing the ability as the <unk>.
Patients to form the of immune response and.
And then what's the balance of great immune response and you'll find.
And from there which is.
Very safe very focused and the mechanism of action is very specific.
Between the two all of the cytokines.
The.
Produced in highly inflammatory is going to be the best and.
The benefit risk ratio the long term and.
<unk>.
Disease views and.
And the safety margin is kind of being extremely.
Yeah.
Well one of the things of that.
COVID-19 has taught US is that one of the addition of less and is that.
Yeah. The reason the room for immune system modulators and immune system suppressors and.
And we see that many of the patients which have been treated on the biologics and all of those very effective shifts.
Drugs and.
Fortunately.
We're exposed to COVID-19, and.
We believe that the reading of the room in the.
And the listen and learn from.
From COVID-19.
The drugs that are.
Scott said with the profile.
As of Middle Fives, and there and we are looking forward to demonstrate all of this.
The superior safety, and Tolerability and efficacy data in our phase one b and face the way studying.
Understood. Thank you for that and.
Thank you.
Thank you at this time I would like to turn the floor back over to Mr. Baja for closing comments.
So thank you all for joining our call as always you are very welcome to contact us.
And we didn't do the next within the quarter before our next.
Our quarterly call.
And we are looking forward to finally.
And finally, you in person and I hope that.
With the ease in the coming very soon and certainly for a number of as can be.
Traveling with the.
And travel restrictions will be lifted and we'll be able to come and visit you very soon.
And both in the U S and Europe. Thank you all for joining the call.
Ladies and gentlemen, thank you for your participation and this concludes today's event you may disconnect. Your lines of of log off the webcast at this time and have a wonderful day.
Hum.
[music].
Yeah.
[music].
Yes.
[music].
Okay.
[music].
And.
[music].