Q2 2021 Galmed Pharmaceuticals Ltd Earnings Call
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Good day and welcome to Goldman Conference call to discuss financial results for the second quarter 'twenty 'twenty..1 today's conference is being recorded before we begin. Please note that we will be making certain forward looking statements on today's call and clean.
Those regarding financial results statements and forecasts regarding anticipated timelines and expectations with respect to our regulatory and clinical development programs as well as other statements that relate to future events. These statements are based on the beliefs and expectations of the management of today and actual results trends time.
Wines and projections relating to our financial position and projected development program and pipeline could differ materially we urge all investors to read carefully the risks and uncertainties disclosed in our filings with the S. C E C, including without limitation the risks under the heading risk factors described.
Banquet Mega mine oral dosage or respond to debt obtained with existing twice daily.
300, <unk>, our ample free acid, which form which is currently being evaluated in the phase III. Our most study.
As a reminder, in addition to its long longer IP protection and in December 2030 for the transition to Encore Mega mine will benefit our patient improvement in 4 ways.
First achieving the required exposure with 50% less API means that we can move back once daily regimen with the potential improvement in convenience and inherent in our phase III Registrational path.
The second benefit the second benefit is that we can potentially significantly with us our target marketing price. Once <unk> is approved we are potential savings of approximately 50% of cost of goods.
We consider the FDA agreement a significant validation of our consistent efforts to maximize the potential of our encore and developing enough treatment.
The transition to <unk> is the final step in our drug product optimization, which included those optimization higher exposure treatment duration optimization 24, 48.72 weeks.
And compound optimization E sold form which tend to given QD and allows longer patent protection.
Now let me update you on the open label part of our more phase III study.
Thank you May recall, the open label, Paul will provide us highly valuable data on the optimization of treatment duration and potential non invasive tests needs associated with Nash and fibrosis.
This is aimed at derisking, our clinical development plan, while increasing the probability of success of our encore almost with institutional book of the animal study.
Results from approximately 1 third of the study population about 50 subjects at the open label part of our more phase III study that has completed the post baseline liver biopsy are expected to be available in Q4.2021 as planned.
Now shifting gear to our pipeline compounds amino fibers.
As a brief reminder, <unk> is a highly potent inhibitor of chronic inflammation currently under development for IBD with targeted and specific mechanism of action.
<unk> done regulate multiple pro inflammatory cytokine secretion secretion in preclinical studies <unk> demonstrated interference with serum amyloid.
The motivation and aggregation, which is essential for the activity of several unrelated day.
Created Cerro Memorial Day is the main call ended biomarker of chronic inflammation.
<unk> has a unique motive action upstream to all pro inflammatory cytokine production, which are currently being used in clinical trials and in clinical use.
Earlier in Q2, we announced the first dosing of our first in human Phase 1 clinical trial of our mirror <unk>, both single and multiple dosing I'm.
I am happy to report you today that we completed phase 1 dosing and top line data is expected later this quarter.
We are currently developing immuno <unk> as an oral treatment from mild to moderate ulcerative colitis.
The mechanism of action is relevant to other chronic inflammatory diseases. We are also looking at additional indications and are currently developing developing formulation accordingly.
Before I conclude I would like to note that we are planning to virtually attend 3 investor conferences in the coming quarter.
The FERC is Canaccord annual growth conference to be held next week on August 10 to 12.2021.
The second is the HC Wainwright annual global investment conference to be held on September 13, 2015.2021.
And lastly, the console global healthcare conference to be held on September 27 to 32021.
We will be happy to schedule 1 on 1 meetings during these events.
Now, let me transfer the call to our CFO <unk> <unk>.
Thank you Alan good morning, and thanks for joining our call today. This morning, I will be providing you with our financial results for the second quarter ended June 32021.
While non formation about report on form 6K, <unk> per day with the SEC, which among other things provides a summary of such financial results for.
For the second quarter of 2021, our net loss totaled $8.4 million or <unk> 33 per share of Covid.
Net loss was $5.8 million or <unk> <unk> per share for the corresponding quarter in 2020.
Research and development expenses totaled $7 million for the second quarter of 2021.
This compares with $5 million for the second quarter in 2020.
Increase resulted primarily from an increase in chemical products assets in connection with our more trials.
Sure.
Turning now to G&A, our general and administrative expenses for the quarter totaled 1.4 million compared with compared with <unk> 8 million for the corresponding period in 2020.
The increase resulted primarily from increasing the cost of our D&O insurance policy premium mature from an increase in salaries and benefits our cash balance as of June 30.
<unk> 2021, which includes cash cash equivalents restricted cash short term deposits and marketable securities totaled $51, 2 <unk> compared with $51 million on December 31, 2020.
With that said operator will provide instructions for the Q&A portion of our growth.
Ladies and gentlemen, if you would like to ask a question you may do so now by pressing star 1 on your telephones.
1 if you'd like to ask a question.
We will now take our first question from Edward Nash from Canaccord Genuity. Please go ahead. Your line is open.
Great. Thank you very much and congratulations guys on getting the go ahead with Ram call metal mine.
That's a huge plus for you guys I know.
So I just wanted to understand I think thank you for that review on the phase Phase III design.
But just wanted to understand again, we're going to be getting those first 50 patients in.
The fourth quarter of this year those patients will be the 24 week is that correct and then the next 50 will be the <unk> 48 in the next 30.72 weeks is that correct.
No hi, good.
No. This is not correct I mean, most patient the patients are blinded randomized into 3 groups. So in this first 50 patients. We will have about half of them are going to be of 24 weeks and the rest 48 and 72 weeks biopsy is these are patients that had transition.
<unk> from the double blind part.
Got it okay. So each group each 50 growth is blinded and mix of the populations of $24.48 and 72.
Perfect got it okay, great and then.
For the for the analysis should still go forward in front of the FDA. Obviously this will give you additional strong debt.
Safety data, but obviously for powering and accelerated approval submission that will all be from the.
Clearly the blinded part where you'll only be using the Ram call Medlar volume correct.
Yes, indeed so.
As you know the study is about efficacy kinetics.
We are using this study for really 3 main reasons, 1 book Pasty, which will support the safety data of our NDA second is to learn what is the optimal treatment duration. When there is 24.48 or 72, if there is a difference and if there is an association between.
<unk>.
And thirdly is the powering moving to study the dose is much higher.
The comparative initially almost study was powered based on the phase II study now we are giving.
Twice daily, which is 50% higher exposure.
We are expecting that the effect size, we changed accordingly, and hence the powering of the study and the number of patients will change accordingly.
Perfect. Thank you guys so much.
Thank you.
Thank you we will now take our next question from Kristen <unk> from Cantor Fitzgerald. Please go ahead. Your line is open.
Hi, good morning, Alan and team. Thanks for taking my questions from let me also add my congratulations to you on the outcome of this recent meeting with the FDA.
First I wanted to ask if you could provide us with more details around the plan to eliminate pharmacology studies and associated timing here and whether you still think the end of the first quarter of 2022 is a good time to start the next trial.
So I will let Lee uptake debt Hello, Kristine good morning, Thank you hi, same Harrington.
We offer is the FAA 3 very reasonable price.
Clinical oncology cities first Glenn is going to do.
With the dose range, finding and as our relevant.
Slide <unk> 300 milligram coal assets and we will.
Do those range finding to match exactly the exposure of the 300 milligram twice daily that we have glitches that Alan alluded higher.
Closer by 52% than they are day.
The second study that we operated food effect, which is quite clear and the final 1 is bio availability from another bioequivalence.
Net guy here.
Yes.
Thank you Larry when you therefore, 1 entity to another when you expect the exposure and just have to match the exposure to the food effect.
Do 1 day.
And match it with the twice daily which is currently in use.
<unk> regular.
Clinical pharmacology and he says.
All the other package, which we this is.
It's fully acknowledged by the regulators of the development.
As to your question about the timelines.
It's very much dependent on the formulation, we already always set and ready and.
The Asia very relevant data that we get at the end of the year.
Should allow us to better design, the protocol amendment and decide on the as I said before duration.
And the powering and the statistical analysis plan of this study.
So this is why an ex.
I think he has done with the CMO in order to.
Produce.
The formulation on time to initiate the double blind part of it.
The study we are on call Mega mine.
So at the moment, we are still getting clear.
Sure.
Guidance about in the once we receive.
The guidance from the FDA, we immediately.
<unk> had discussions with our drug product manufacturer, who will initiate the process and complete the formulation. We will keep you updated and give me any delays.
Slip into Q2 from Q1, we would only know.
Once we have more visibility as to the formulation development.
Okay.
Thanks, I appreciate that and now that you have the official greenlight here from the agency just as it relates to some of your ongoing collaborations, particularly the combination study with ASC 41 will you also look in the future to use net remind forward here and then as it relates.
You've evening multiple comments in the past about using your therapy potentially as a backbone, but how might this data that we're getting in the fourth quarter here help you determine.
Future plans as it relates to evaluating different types of combinations as well.
Absolutely I mean from.
Now onward, we are using our encore melanoma. So the first will be to incorporate <unk> meglumine in the open label study.
I hope that this will be done already by the end of the first quarter of 2022, and then all other combination studies, where there is.
ACC 41, or the microbiome or others that we Havent plan and we've communicated are going to be done together with RM core melanoma is the product that we're taking forward.
An improved product and we would like all of our patients to benefit from this improved product.
Okay. Thanks, I appreciate that and then my last question for you now that this again. This agreement is in place and you have an extended IP portfolio has this changed how you might think about the opportunity to commercialize specifically, whether you would look to pursue partners.
Certain geographies again now that because the IP portfolio has strengthened thanks again.
Yes. So so yes, we are always and have that openly said, though I mean, we are working under the assumption that we are developing our own core magnum <unk> and taking it into phase III.
Our door is open.
And we are definitely looking for.
Global geographic.
Joining venture any form of collaboration I think that we have built a very nice.
For any pharmaceutical companies that we look at the data that goes on day 1.
We are optimizing the API and drug product, we did all the heavy lifting in terms of they're getting the regulation from all the way from Australia to Brazil and China.
U S of course, Middle East Korea, or whatever I mean, we're talking to Asian countries.
Agreements with more than 250.
Sites.
Around the globe are on 5 continents for OLED heavy lifting together with the optimization of the drug product.
On the 1 hand and on the other hand, giving the partner and opportunity to influence the protocol because im sure that everyone everyone wants to make an to review before you initiate the double blind spot makes it we want to make their own adjustments and fine tuning and we are very open to that.
So between today and.
Can we start.
<unk>.
Double blind part of discovery.
We are.
Open for discussion.
Any any any.
And any.
Commercial discussion.
Thank you.
We will now take our next question from Steve <unk> from Raymond James. Please go ahead. Your line is open.
Yeah, Hi, this is more volume on for Steve.
Yeah also I'd like to congratulate you on the agreement for <unk> and just to make sure I understood correctly. So the main gatekeeper.
Back before you can start a randomized phase III study.
You were talking about material needing to be manufactured but they also obviously we need to see.
Some label.
Arm called data. So quick could you just talk about what kind of data you would need to see before you can proceed with the randomized study is sort of what is the benchmark for that data. Thank you.
So thank you. So thank you for the question because I think this is this is a very important.
Issue.
Uh huh.
Here at <unk>, we are looking at the data very carefully not only in our data on the competitive landscape data as well and.
And we have to ensure that our data is in line.
Our would be.
What is the August.
Product profile of <unk> is in 9 of the NAV of the development in the index.
In this space.
We are very much aware of the recent.
Industrial solutions, rather than the <unk> on the.
Whether it's the chemical side or other compounds that.
Have a very significant effect on our full solution.
On the other hand, the very mild effect that we will observe on fibrosis.
From the.
From a particular assets. So altogether, we are trying to build the best efforts in west, Texas the benefit from scratch at our patients that would be both Nash resolution.
Fibrosis improvement and safety.
This is a kind of the data that we anticipate to see from the open label study may be the first 50 patients would not be enough, maybe we need to wait for the 100 to 160.
We are hoping that day.
We had seasonally strong enough signal with the FERC participation but.
We will look at the data and we say we want to wait another quarter or another 2 quarters until we see 100 patients and then decides on to embark on this.
Large expensive.
<unk> III study double blind part of the study.
We'll definitely to do that is.
Because I think we have the responsibility to our patients and to our investors.
And we want to make sure that once we go into debt route.
Initiating.
Double blind part of the study.
We have significantly derisked the.
The program and increase the probability of success.
This weekend we've planned.
The 2 programs to crop.
So we developed the <unk> line, we gave it 2 formulations we are doing.
The debt Commendation for Encore online and ex the same time vessel will arise from the Cana.
Netflix Sophisticate day, and they'd be noted day.
Somehow approximately will crop.
And we will have financing and the formulation stability and everything that we have accomplished and economic time.
Time, approximately we will probably have debt.
I found the kinetics that we will have a.
Hey, good design.
The phase III clinical trials.
Hum.
Regulatory clinical claim.
Okay. Thank you for that.
Can you also talk about the cadence of additional cohorts from from the open label study.
If I remember you were saying every 6 months Im not sure Youre next cohort data will still be around mid 2022.
Or is that.
That timing difference thank you.
No. This is correct. The next cohort is anticipated by the second quarter of 2022.
This is the 100 patients.
So the first 60 and then another 50 by mid 2022.
Okay, Okay, great and then.
For 1 question for another 5 <unk>.
So I think.
Talked about going after Orleans sub Q for phase 1 be for different indications.
Can you just talk about.
In terms of your oral formulation.
Bill systemically the ship.
Versus minimally absorbed.
Just to clarify phase 1.
That's right.
Right.
So the phase 1 was non sub coupon.
<unk>.
Sure.
And with healthy volunteers and now we are working on food pack per formulation, we are working on oral local formulation.
Which is for the for the 2 for ulcerative colitis for the Gi swap book.
Working with the specific formulation that would be when we open.
In the right place, where we wanted to open and create at a local effect in the Gi tract.
This is designed formulation is designed for.
Phase Iia study for <unk>.
Rapid classification.
The same time, we're also working on localized formulation this would be injectable.
And again for a different indication probably already.
It would be Injectables will join.
This formulation we may also look at other indications.
But it's too early to talk about.
Okay. Thank you very much.
Thank you. Thank you.
Thank you that will conclude our Q&A session for today's call I will now turn the call back to Allen.
Ross for any closing remarks.
So thank you all for joining our call today.
I hope that.
We'll be able to come with more good news and day.
This coming quarter and eventually of course to communicate.
Right.
This open label part of the study.
We are again.
I'd like to reiterate our participation in the 3 conferences in the Canaccord annual growth conference at the HC Wainwright confirmed and the Cantor conference.
Which we welcome.
Any questions and would like very much to meet as many of.
<unk> and <unk>.
And of course.
I hope to see you.
Probably are virtually also at <unk>, where we've submitted.
A number of obstruct.
Which I hope will be accepted and.
We can debt would be an additional catalyst for our activity. Thank.
Thank you.
Ladies and gentlemen that will conclude today's conference you may now disconnect.
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