Galmed Pharmaceuticals Ltd. Q1 FY2020 Earnings Call

Good day. Welcome to Galmed’s Conference Call to discuss Financial Results for the First 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 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. In particular, there is significant uncertainty about the duration and severity of the COVID-19 pandemic, its impact on Galmed's business and operations. We urge all investors to read carefully the risk and uncertainties disclosed in our filings with the SEC, including, without limitation, the risks under the heading Risk Factors described in our annual report on Form 20-F filed with the SEC, and the risks and uncertainties included in the Form 6-K filed with the SEC earlier today. Galmed assumes no obligation to update any forward-looking statements or information, which speak as of their respective dates only. I would now like to turn the call over to Allen Baharaff, President and Chief Executive Officer. Allen, please go ahead.

Thank you, Sherry. Good morning, and thank you for joining us on today's conference call. I'm pleased to be here today with our Chief Scientific Officer, Dr. Liat Hayardeny; our Chief Medical Officer, Dr. Tali Gorfine; and our Chief Financial Officer, Yohai Stenzler, to provide you with an update on our clinical development programs, as well as report to you on our financial results for the first quarter of 2020. As always, we will be happy to take any questions you may have at the conclusion of our prepared remarks. I'd also like to say, I hope you and your family are safe and well, as we work to overcome the COVID-19 outbreak. I know this issue is very much on your mind, and shortly I will provide an update on its impact on our operations. I'm delighted to share with you today new preclinical PK data comparing Aramchol free acid, the drug substance that is currently being evaluated in our ARMOR NASH Phase 3 study with our new form of our Aramchol, Aramchol meglumine. Over the last few years, Galmed has been in the process of developing a new product, Aramchol meglumine, which is a sole form of Aramchol free acid. It is important to note that Aramchol meglumine and Aramchol acid circulate as Aramchol regardless of which drug product is administered. Our research found that meglumine served as Aramchol, increasing the scalability of Aramchol by five orders of magnitude, which was a surprising result considering the art of pharmaceutical chemistry. Based on this data, we submitted in December 2014 a new composition of matter patent protecting Aramchol meglumine, as well as a wide range of other sources worldwide. Of importance, Aramchol meglumine is considered a new chemical entity, and as such, it is eligible for new chemical entity patent protection until December 2034. Patents were already granted and maintained in 37 European territories, in Japan, Australia, China, and Canada. Discussions on the patent protection in the U.S., India, and several other jurisdictions are ongoing with the relevant patent offices. We are aware that without these important developments, concerns about patent protection for Aramchol existed, since the U.S. patent for Aramchol free acid for the treatment of fatty liver would otherwise expire in 2023 before any potential Hatch-Waxman patent expansion. Now, results from single and multiple oral administration doses of Aramchol free acid and Aramchol meglumine in a crossover PK study demonstrated bioequivalence with reduced variability. In particular, after single-dose administration, the AUCs for Aramchol free acid and Aramchol meglumine are almost identical; after multiple dosing, the steady-state AUC for Aramchol meglumine was higher compared to Aramchol free acid; of major importance is a three-fold reduction in coefficient variation in steady state in the Aramchol meglumine arm, compared to Aramchol acid, suggesting low variability among patients receiving Aramchol meglumine in the future, which is a major added value. The half-life of Aramchol during the administration of both Aramchol acid and Aramchol meglumine is identical in single and multiple dosing steady state. This data supports the same ADME profile for Aramchol and Aramchol meglumine. Cmax was higher in Aramchol meglumine compared to Aramchol free acid in steady state. We plan to submit these results along with other supporting data to the FDA, and discuss with them as soon as practical, a plan to appropriately transition from Aramchol free acid to Aramchol meglumine in the ongoing ARMOR Phase 3 study. Based on our regulatory and scientific review of relevant FDA guidance and precedents, our assessment is that this change during Phase 3 could be considered acceptable provided bioequivalence of the two products is established, and a number of other data considerations are addressed. We are planning to hold in the coming months a virtual Analyst Day to discuss all the details of this program. I would like to move now to report updates on our ARMOR Phase 3 NASH study, as well as to assess the evolving impact of COVID-19 for the first quarter of 2020. As an Israeli-based company, working under disruptive events is almost second nature to our way of life. More so, our long experience working across different time zones has required us to adopt remote work arrangements pre-COVID-19. Thus, the pandemic had very little effect on our ability to maintain our regular operations. In reaction to the rapidly evolving global pandemic, affecting the safety of our patients, side practices, investigators, and burdens on hospital systems, and in accordance with local restrictions and regulations, we decided to temporarily halt the screening of new patients for the ARMOR study. Throughout this time, we maintain open and close communication with clinical study sites and our partners in the management of the study. We continuously monitor and perform thorough assessments on a regular basis according to the local situation in the U.S. and other countries worldwide, aiming to resume activity on a country-by-country, state-by-state, and site-by-site basis. Accordingly, during Q2, we expect to lift some constraints in states in the U.S. identified as green states, allowing individual investigators to determine whether it is safe to resume screening activities. We are using the time to advance the approval and initiation of additional sites in new and existing countries. Such activities will allow us to minimize the ramp-up time for site activation, so that we expect many sites will be ready for activation when screening and randomization become possible. Our current assessment is that by Q4 2020, we should be able to resume recruitment in many of our sites. Accordingly, we are moving our guidance for completion of recruitment of patients for the first part of the study from Q2 2021 to Q4 2021 and reporting topline results for the first part of the study from Q4 2022 to the second half of 2023. Of course, the rapid development and fluidity of the COVID-19 pandemic preclude any firm estimates as to the ultimate effect this disease will have on our study and is subject to change. To help mitigate cost overruns, we’ve taken several protective measures to reduce costs. We have minimized all clinical-related expenses, mostly to the ones which are mandatory for the monitoring of randomized patients. As communicated in our previous investor calls, our clinical expenses are directly correlated to patient enrollment, and therefore delays in enrollment also reduce our cash burn until patients are enrolled in the study. In addition, we made adjustments to clinical staff and pay according to the current and predicted level of activity and reduced the cash fee of the board by 50% for the first half of 2020. I would like to take this opportunity to express our sincere gratitude to our investigators and the clinical teams, who are going out of their way to avoid unduly early termination while assuring patient safety and scheduled follow-up. Before we open the call for Q&A, let me turn the call over to Yohai to provide you with an overview of our financial position at the end of Q1. Yohai?

Thank you, Allen, and good morning, everyone. This morning, I will be providing you with our financial results for the first quarter ended March 31, 2020. For more information please refer to our report on Form 6-K filed earlier today with the SEC, which, among other things, provides a summary of such financial results. For the first quarter of 2020, our net loss totaled $6.1 million or $0.29 per share, compared with a net loss of $3.5 million or $0.17 per share for the corresponding quarter in 2019. Research and Development expenses totaled $5.6 million for the first quarter of 2020 compared with $3.3 million for the first quarter in 2019. The increase resulted primarily from an increase in clinical trial expenses in connection with our ongoing ARMOR study. Our general and administrative expenses for the quarter totaled $0.9 million compared with $0.8 million for the corresponding period in 2019. The increase resulted primarily from an increase in non-cash stock-based compensation expenses. During the three months ended March 31, 2020, we had a net financial income of $0.4 million versus $0.5 million in the previous quarter. Our cash balance as of March 31, 2020, which includes cash, cash equivalents, restricted cash short-term deposits, and marketable securities totaled $69 million, compared with $75.6 million on December 31, 2019. With that said, operator, please provide instructions for the Q&A portion of our call.

Thank you. Our first question is from Yasmeen Rahimi with ROTH Capital. Please proceed.

Hi, this is Petunia Ing on for Yasmeen. Thank you for taking our questions. So two questions for you. First is, can you provide some color on how the safety profile of meglumine compares to Aramchol, whether there's any completed long-term data to get clearance for Phase 3? And what does the FDA need to allow you to switch from Aramchol to meglumine? And there's a follow-up. Thank you.

Thank you for your question. We are developing a compound called Vyndaqel and Vyndamax, which consist of tafamidis meglumine and tafamidis free acids. Both of these treatments were approved in March 2019 and are supported by the FDA. They contain the same active ingredient, with tafamidis acting as the speculated agent in plasma. The data submitted for both forms is interchangeable, and we achieved approval for both. The toxicology of meglumine is well established, allowing us to progress without the need for further toxicology studies based on existing data used with meglumine.

Okay. Thank you. That's very helpful. And the follow-up question. How many patients have been dosed with Aramchol? And if you switch to meglumine will the data set from Aramchol and meglumine be combined in the final analysis? Thank you.

We are not disclosing this information, Yasmeen. Once we reach a predetermined milestone of randomized patients, we will disclose the information.

Our next question is from Steve Seedhouse with Raymond James. Please proceed.

Yes. Hi. Thank you. Interesting development. Liat, I think I couldn't hear you very well. I think you were just talking about the tafamidis and the precedent here for the meglumine salt. And my understanding is that Vyndamax and Vyndaqel, so the free acid of the meglumine salt actually dosed differently on a milligram basis. I don't know if that's because of the pharmacology of tafamidis or if there actually is sort of a question about interchangeability of the dose of the salt versus the free acid. So I'm just wondering if you can comment on that. Is there a point of uncertainty about whether you can actually just swap in one for the other and keep the same dose? Or do you have to do some dose-finding or even add multiple doses to the Phase 3?

So, thank you, Steve. In the case of tafamidis, the dose assessments are per AUC or exposure and not the dose. Well said by the way. The acid was adjusted to 61 milligrams plus 80 milligrams in meglumine salt, because the active compounds are different. So the FDA actually went one step further in allowing adjustment of exposure and not for dose. You're right with your questions. It's not the same as adjusting the same dose administration and the same dose regimen as you would do with generic. This is a different case.

Okay. So maybe following up, does this give you…

Just bioequivalence is here clear exposure. So you do AUC per AUC, exposure is in the amount of the compounds that you think are in the plasma of the patients, and not at the dose that you're giving.

Okay. A follow-up to that would be, does this give you an opportunity to go return to once daily dosing? Or are you going to stick with the BID dosing that you had previously sort of switched to, based on the PK study?

We will do every possible way but cannot promise anything at this stage. We are putting a lot of effort into that, and if it's not going to be in as part of the Aramchol, it will be as a life cycle management, as we are putting every effort in formulation for that exact method that you're asking.

Okay. And then could you just talk about your level of confidence and the non-obviousness of the innovation step here of the meglumine salt and its patentability in the U.S.? Any worries there? Because I noticed you mentioned that discussions regarding patents in the U.S. were ongoing with USPTO.

Yes. I believe the numbers are quite clear, as I've already mentioned, that 37 European countries, along with Japan, Canada, and Australia, have accepted it. There's no doubt about that. The surprising aspect is when we compare Aramchol meglumine to other salts; the features of Aramchol meglumine stand out distinctly. As you know, patent offices operate independently. The pace of processing varies by country, with some moving quicker than others. However, we are very confident. A five-fold biosolution of a compound is unlikely with patients.

Okay. I appreciate that…

Liat is correcting me. 30,000-fold of solubility.

Yes, of solubility than Aramchol acid.

30,000. Three zero. 30,000-fold solubility.

I see. Okay. That's a lot. Last just a quick clarification question. So in the press release, you mentioned that the innovative step here has led to a new chemical entity patent. Because there are multiple terminologies here, I just want to make sure I'm understanding that correctly. So this is in fact a product patent or a composition of matter patent and not a formulation patent. Is that correct?

That's absolutely correct. It's a new composition of matter patent, and in fact, it might even be on an independent IND. It's a new chemical entity. This is not just a formulation.

Alright. Thanks so much for the questions.

Thank you, Steve. Thank you for your time.

Our next question is from Edward Nash with Canaccord Genuity. Please proceed.

Hello, Galmed and team. This is Adam on for Edward today. Congrats on the press release here. Steve and Yasmeen got most of my questions, but just one more for us. Could you add any more color around the current status of research sites, worldwide on a regional basis? Like whether there are any open sites as China seems to have mostly reopened? And a related question is, how are you approaching or planning for a second potential spike in COVID cases in the fall?

Let me start with the second question about the second wave. Interestingly, though we are running a global study, we are getting daily news from five different continents. And, I'm sure you're aware, there are different waves and different timings in different countries and regions. So, we feel that some areas like Australia, we feel very confident that we had very few cases recorded to start with. And we feel that Australia will probably start recruiting very soon. Korea has already passed the first wave. We recently had a very successful webinar with our Korean investigators, and they are eager to start recruiting patients. So, I think Korea will also be a second country to reopen the recruitment. And the U.S., you know better than we do, it’s not homogeneous. So we need the input from the investigators. We’re getting literally daily requests from investigators to reopen their sites. And we are monitoring that and we want to ensure it will be done gradually and only if we feel convinced that they will not need to close that again for a second wave.

No, you more or less answered it in answering that second question. So, thank you very much for that.

Thank you.

Our next question is from Adam Walsh with Stifel. Please proceed.

Hi team, how are you? I hope you're well. A couple of questions here. I just want to be clear, I was having difficulty with my connection. I couldn't hear all that well. Allen, is there any chance that you'll have to restart the trial essentially with patients with the meglumine? I mean, in other words, is there any chance that the current formulation is going to have to be superseded by this one with a whole new set of patients?

So tafamidis, we are using tafamidis as a very good precedent. And they've made the change during the study with cross-reference data from one formulation in free acid to the meglumine. There is no reason why we should not be able to do the same. Another example that you may be aware of is statins, where they changed formulation from amorphous to crystalline within Phase 3 and began to restart the study. There are a number of FDA guidance documents on this. It hasn't happened a lot, I must say, but it has been done before, and tafamidis gave us an excellent, very timely precedent, because it was only approved in 2019. And as you know, we can access all the data, both from Europe and the U.S. We are relying heavily on that, and of course we had regulatory consultants that we consulted with along the process before we decided to take this change. So we feel comfortable that the FDA would accept this view.

That's helpful. And then you mentioned that you're going to have an Analyst Day in the coming months. We could potentially get clarity on some of these issues at the Analyst Day. It seems that for the meglumine there's a couple of things that are important to you. One is the potential for U.S. patent and the other is the FDA sign-off on potentially integrating the new formulation into the Phase 3. Would you expect both of those to kind of precede the Analyst Day? Or is the Analyst Day kind of independent of those two items?

Sure, Adam. First of all, I want to clarify, it is not a new formulation, it's a new compound with a new chemical entity. This is a very important change. This is a completely different patent protection. By the way, tafamidis acid was approved without a Phase 3 study; this is very interesting. They used cross-referenced data from tafamidis meglumine, and without running a Phase 3 study, they got approval and R&D approval for tafamidis base. This is an interesting point to discuss about the cross-referencing data. We are doing our best, but COVID-19 has disrupted our plans a little bit, because I'm not sure when the FDA will be able to allow us to present the data and how long it will take until we get a reply. Thus, we will have to juggle between our core data and that we receive from the FDA and our intention to provide additional information in this Analyst Day. We also would like to discuss our pipeline product in this Analyst Day, so I hope that it will be done sooner rather than later. But it also depends, as I said, on things which we are not dependent on, like FDA responsiveness.

That's great. And just one final one. Allen, we've had data from other NASH companies coming out. I wonder if you could maybe opine on how Aramchol kind of stacks up and your thoughts on the space in general as it pertains to Aramchol? Thanks.

So, I think Tali would be a more appropriate person to do so. Our CMO, so I’ll let Tali answer.

Okay. So indeed, this week has highlighted many questions we have been considering for a long time. We are, of course, disappointed with the GENFIT results. We’re curious about the normal Phase 2 results. Like everyone, we are awaiting further information about potential contributions to the higher placebo rates. That includes the usual suspects, weight loss imbalances, and some of those indications too. For example, the lifestyle intervention and I think also methodology for the topology need. So, we're always seeing some more information, and I think it will be very, very important for the field. At the end of the day, the active treatment has to be placebo, and the magnitude of effectiveness measures within one study is relevant to the placebo rate in another study. I think the best example is plant and regenerates weather fibrosis improvement values with 21 versus 14 plants and 12 versus 23 in January. So, this placebo rate but still the magnitude of effects about double. With respect to Aramchol, we have emphasized all along, it's a liver-targeted treatment, and we think this is highly important. It has the mechanism of action and clinical data to support an effect on both the natural evolution and fibrosis improvements. Again, we always emphasize that these two go hand-in-hand and are desirable for a NASH drug. The ARMOR study is a large study. It's powered for both endpoints. Add to that the population which we continue to maintain, that will be an enriched randomized population. So, altogether I think that we will learn from the information that comes out about the ARMOR study, and Aramchol is well on track for good products.

Thank you.

Our next question is from Kristen Kluska with Cantor Fitzgerald. Please proceed.

Hi, everyone, and thanks for taking my questions. I hope that everyone at the Galmed team is doing well right now. So, the first question I had is, are you able to discuss whether IP was a topic that was asked about during your ongoing partnership discussions? And how do you think this might change now that there have been some developments in the NASH phase in general and also you may have extended IP here? Thank you.

So, it's too early. I think, I'd like to see more data coming from the study from the GENFIT study. And clearly, there is one less Phase 3 candidate in development, which I must say personally, I feel very sad about because for 20 years GENFIT has been part of my life. In fact, it's for the patients and for everyone who is involved in this study over the course. But we always say this is a marathon run. As a marathon run study, as I said before, we are planning the study as a robust, long study to meet both endpoints, and we keep on our mantra that we think that Aramchol is the best candidate in the market for the chronic treatment of NASH. I hope that through this new patent life, we would remove any overhang that was on such things.

Okay, thank you. And do you anticipate to plan on planning or to discuss keeping the fast track designation status for this?

It's still early. I mean, we are not sure yet. This is something that's up to the regulatory consultants, whether this is going to be an independent IND, or we are going to tag along to the existing IND. If it will be an independent IND, then yes, of course, we go for the fast track, but it may likely be that the faster way to go is not to a Type B meeting but to a Type C meeting and continue the development with the same IND. So, I won't be able to tell you until we have guidance from the FDA.

Okay, thank you. And I know you haven't disclosed the number of patients that have been treated thus far. But could you talk about whether you anticipate any challenges and if there are any solutions at this time to collect follow-up data from patients during these times?

Tali?

Yes. So actually I must say we are heart warmed by the dedication of the investigators and the patients to remain in the study. While we allow flexibility along the lines of what is allowed by regional and regulatory guidelines, we see that all our patients are ongoing and that their follow-ups are performed adequately. And this is very reassuring.

Okay, thank you. And then my last question here is Intercept's tentative FDA AdCom meeting is scheduled in a few weeks from now. So I wanted to ask what you, as a late-stage NASH developmental company, are on the lookout for as it relates to your own company and program. Thank you.

I'm not sure. Could you repeat the question? I'm not sure really what are you asking?

Sure. So Intercept AdCom is scheduled to take place in a couple of weeks from now. So I was curious if you had any thoughts about whether there were any topics or questions you might think could happen that you might consider based on what Intercept has experienced? So that down the line, when you potentially file for approval, you can take those considerations into account.

So like you, we are awaiting this advisory board. Intercept has paved the way for a long time in the NASH field. Now we're at a critical milestone, and we will learn from this AdCom exactly what is required for a successful NDA. We still have time to adapt as required for things that may come up in this AdCom.

Okay, thank you very much. That's very helpful.

Our next question is from Jason McCarthy with Maxim Group. Please proceed.

Hi, everyone. It's Dave on the line for Jason. Thanks for taking my questions. I hope you guys are staying safe. So I just wanted to see if you guys had any concerns about the new salt formulation of Aramchol potentially exacerbating high blood pressure in patients with hypertension, especially given the fact that high blood pressure can potentially be a contributing factor to the development of NASH. Thanks.

So thank you for the question. But we have no such concerns. There is no signal on hypertension with Aramchol. The safety of the product we have disclosed many times, and hypertension is not one of them.

Okay, thank you. I appreciate the clarification.

Our next question is from Ed Arce with H.C. Wainwright. Please proceed.

Hi, everyone. Thanks for taking my questions. I’m very happy to hear that you are and have been addressing this long-standing overhang of the short patent protection. You and I, Allen, have talked about this on numerous occasions in the past. So, I know this has already been touched upon by several questions previously, but just wanted to drill down a bit further. Clearly, this is a new MCE and you're filing or have filed the CMO patent. My question is, you're clearly confident on this path. I guess what my question is on the two key areas here with the FDA and the USPTO. What could potentially go wrong? Where are the key areas of risk where despite everything you've done to date, there could be either some disagreement or even just a delay on moving forward?

Thank you, Ed. So, it's a yes or no question. This is not something that has shades of grey; of another formulation, whether this formulation can be accepted or not. It's about the essence of patents—whether it's novel or not. And here, we have received very few statements coming from the patent offices, as I said before, 37 independent patent offices, which all granted us the new composition of matter patent with flying colors. Discussions in the U.S. may take a bit longer; they may be more prudent, but we feel very good. We had extremely good arguments, and it’s almost impossible for us to envisage a possibility that this patent will not be accepted. We feel very strongly about the patent. It's not the huge patent; it's not the formulation patent; it's a very strong new composition of matter of something that's unprecedented, neither did we expect this outcome. And I'm sure that—we don’t see any risk in applying for the programs because we are advancing this transition. Sometimes it takes a bit longer to have the patent granted, but that wouldn't change anything in our plan.

Okay, thanks for that clarification. Another question is...

And just to clarify, Ed, one other thing: there is no development on—this is a continuation of the same compound. So, there is no—it's not a different moiety that has had any developmental changes in terms of the product itself.

And maybe just to add on what Allen is saying, the synthesis process is very well defined and validated. There are no impurities, and the validation processes are all set. We don't see any problem in the chemical developments of CMC that are related to this compound.

Great. Thank you, Liat, for that. So, another question is there are a couple—while this is a very similar compound, of course, it's distinct and novel, and there are two areas that you mentioned are different, the higher steady state AUC and the much higher solubility. You mentioned before that given those attributes, you will be trying everything to see if one daily dosing is possible. Are there any other specific benefits or attributes that you would look for that would be an improvement over the data we have seen to date with Aramchol?

This is a great question, and thank you for asking this. When you have a compound which is class 4, there is a very slight variation in exposure among patients because it’s not soluble. So, with Aramchol meglumine, the main added value is reduction in the coefficients of variation. I think that the exposure of all the patients is going to be quite similar and not very much varied from one patient to another. This is a very good—it’s a very significant added value when we talk about pharmaceuticals, that the exposure among patients is almost similar and not variable. It gives you a lot of homogeneity when later on looking at the clinical data.

Great. That's very helpful. And then just one last question for me. Given your extended timelines here and a certain degree of lack of visibility here, at least in the near term, are you prepared to give us an estimate of your cash runway?

So it hasn't changed. We still have the cost of the study as we said earlier, is not going to increase because of this change. There will be some additional CMC costs, but this is budgeted, and we keep the same burn rates. We are still a relatively small company. So we have a very managed burn rate, which is about $1.5 million U.S. dollars per quarter, as you can see. The additional costs for preparing the additional Aramchol meglumine are already accounted for in our budget.

Okay, great. Allen, thank you so much for this, and congratulations on this development. I look forward to your Analyst Day coming up.

We look forward to it. Thank you.

And our next question is from Mayank Mamtani with B. Riley FBR. Please proceed.

Hi team. Thanks for taking my question and congrats on the progress. Most of my questions are addressed, but I do have a couple of quick follow-ups. So as you think about the process of engaging the agency and also sort of what human studies you may have to do with the NCE? And what sort of process? Is it like a Type C meeting you would have to have with them? Like very similar to the meetings I think you went through last year with the BID versus QD, where obviously you had to do the bioequivalence and drug interaction study. Could you just clarify that piece? And also I know for your NDA you had these other early-stage studies like hepatic impairment, mass balance; what is the impact on that?

So the only thing that we are currently doing, of course, is going to bioequivalence in humans and just to see that we are around the target. We will do, we will try to do our best via a very good formulation or few formulations to maybe allow reductions from BID to QD. I'm not sure this is going to be possible. We do need to stay within our AUC, within the exposure, in order to be able to use all the data that is coming with us—i.e., toxicology and everything that's accumulated as fast. So, we will stay within the range of the exposure of Aramchol BID-300 milligrams even now in ARMOR.

So, just to clarify, we are not aiming for higher exposure. We are keeping the same exposure, the same way and philosophy as generics are being developed. Hence, we will only need a Phase 1 bioequivalence study. We don’t need any other toxicology drugs or interaction or any of these kinds of studies are not needed. It’s preclinical data and the Phase 1b data.

Always remember that the circulating active moiety is the same. We're still talking about circulating Aramchol in the plasma, and everything that has to do with this from this point of view is the same active ingredients.

And could you clarify the impact on other studies that you started? And I think one other study had to have data by the end of the year. I think the hepatic impairment.

So the only study that is ongoing is the hepatic impairment, which is proceeding. Again, it’s not going to be impacted, and other Phase 1 studies are not going to be impacted as well. The other study, the mass balance, is also advancing. It’s a widely-labeled compound, so it takes a bit longer. The rest of the studies are still planned; some of them are delayed because of COVID-19. But we don't think there is any urgency in completing these studies. Those are studies needed for NDA.

Great. And then a follow-up on the Phase 3 ARMOR trial design. Have you disclosed your following assumptions? And also on this, underlying all concomitant medications? Of course, you have the diabetics as a majority. But what are you allowing versus what are you excluding in terms of anti-diabetic drugs?

I don’t think if I heard the question correctly. We have in the protocol and we can provide you more detailed information, but we have written the inclusion and exclusion criteria very meticulously and aligned with the FDA guidance that was out. We allow diabetes medication if they are stable for different time points and different durations depending on the drug. Of course, we only enroll stable patients based on hemoglobin A1C and other parameters. So we make sure that the patient at the time of screening or baseline is stable and on stable medication. Now of course we know that the study is a long study, and patients may require adjustments or changes in their medication, by the way, the same for diabetes and other core comorbidities like hypertension, dyslipidemia, etc. So all these standards of care adjustments may happen during the study and we do not impose any specific disallowment on such required changes. The RFQ does—we ask the investigator to consider the indication and sometimes discuss with us. But based on, we have no disallowments on specific drugs for diabetes or other comorbidities. Maybe you've asked because of drug interaction due to your previous questions. So I may also add that…

And also the learnings from the GENFIT study and the placebo response there and also the metabolic parameters not really showing that much of a difference drug versus placebo.

So we don't have yet. The GENFIT hasn't disclosed whether concomitant medication is related to the placebo response. Actually, in the initial call they had, that day I listened to it and they said that the first look they have done indicates that probably weight loss and concomitant medications are not responsible for the higher placebo response rate. I don’t have more information than you on this issue.

Great. Thanks. Thanks for taking my follow-up question.

Okay. I don't know if I answered with respect to drug-drug interaction. We don't have concerns about either diabetic medications or patients regarding drug-drug interactions.

That's great to hear. And look forward to seeing more of the data at the Analyst Day.

And that concludes our Q&A session. I would like to turn the conference back over to Mr. Baharaff for closing comments.

Thank you very much. So thank you all for joining our call today, and I wish you all to stay safe and well. As always, please do not hesitate to contact us for any follow-up questions that you may have. Until then, bye-bye.

Thank you. This does conclude today's conference. You may disconnect your lines at this time and thank you for your participation.