Q3 2020 Matinas BioPharma Holdings Inc Earnings Call

Greetings welcome to my team is bio former third quarter 2020 results conference call. At this time all participants are in any listen only mode. A question answer session will follow the formal presentation. As a reminder, this conference being recorded.

Now I'd like to turn the conference over to Peter Vozzo Investor Relations representative from a team as biopharm or you may begin.

Thank you Latania good morning, everyone and thank you for joining the machinist Biopharma third quarter 2020 results conference call earlier. This morning, we issued a press release with our third quarter 2020 financial results along with business updates. The release is available on the genus Biopharma Web site under the Investor section.

Speaking on today's call will be carried you bore chief Executive Officer, who will discuss the company's corporate progress and key milestones Keith Kaczynski, Chief Financial Officer will then review <unk> third quarter financial results. We also have dr. carry back if it's cheap.

Oh that officer, Dr., Terry Ferguson, Chief Medical officer available to answer questions during the Q.

At this time I would like to remind our listeners that remarks made during this call may state management's intentions hopes beliefs expectations or projections of the future.

Forward looking statements involve risks uncertainties forward looking statements on this call are made pursuant to the safe Harbor provisions Federal Securities laws. These forward looking statements are based on the keenest Biopharmas current expectations and actual results may differ materially as a result, you should not place undue reliance on any forward looking statements.

The factors that could cause actual results to differ materially from those contemplated by such forward looking statements are discussed in the periodic reports the keenest Biopharma filed with the Securities and Exchange Commission. These documents are available in the investors section of the company's website and on the FCC is website.

An archive of this call will be posted to the company's website also in the Investor Relations section [laughter]. Following the company's prepared remarks, we'll open the call for questions and answers session I will now turn the call richer.

Thank you Peter Good morning, everyone and thank you for taking the time to join US today as we provide a business update and discuss our 2023rd quarter results.

Overall, we made great progress across our entire business during the third quarter, which was marked by several very important accomplishments.

First as everyone is aware in July we commenced part two of the Enac study with Matt 22, or three dosing and the first cohort of 10 patients.

Taking all necessary steps and precautions to initiate dosing following a temporary pause due to cope in 19 with a key objective for the company in the third quarter.

More recently, we completed this portion of the study and in October the independent data and safety monitoring board or DSMB be reviewed the first cohort data and unanimously recommended progression into the second patient cohort.

This was a significant milestone for the company. It provides great optimism as the Enac study moves forward.

Our enthusiasm is not only focused on the development of about 22, all three as the potential gold standard for the treatment of invasive fungal infections, but also extends to our overall LNC platform and the potential broad therapeutic applications that are available for medicines that can be orally administered.

With less systemic toxicity.

And with targeted intra cellular delivery I.

Well go into more detail on the NACC and our LNC platform shortly.

But we believe that the market has yet to fully appreciate the differentiating characteristics of our LNG platform and the significant challenges that it may be poised to solve.

Challenge is that little bit nano particles and viral vectors have unfortunately, not been able to overcome despite widespread adoption.

Second we completed enrollment in the enhanced that study a second head to head comparative study of <unk> 9001 versus the SEPA weaker.

We continue to be on track to report topline data from this study in the first quarter of 2021.

Lastly, we had a very successful end of phase two meeting with the FDA and are fully aligned with them on the key elements of our phase three development program from <unk> 9001, which we expect to initiate in the first half of 2021.

Well go into more detail on or about 9001 program and recent F.D.A. interaction later in the call.

Let's begin with Matt 22, or three our oral lippitt now crystal where Alan Tse formulation of the highly potent broad spectrum anti bundle drugs and Paris and B.

Currently in phase two development in the Enac study, which explores the use of map 22, all three for both induction and maintenance treatment of cryptic coppell meningitis in HIV infected patients in Uganda.

The next study, which has been actually supported by the National Institutes of health.

Two distinct parts.

The first part focused on safety and was completed late last year and demonstrated that Matt 22, or three was well tolerated and safe in subjects infected with HIV, but who did not have an active cryptococcal meningitis infection.

Moving out of the first part we identified the highest possible tolerated dose to then bring forward into the second part of an act, which is designed to assess both safety and efficacy of map 22 or three in HIV patients with an active cryptic complement the Janus infection.

The second part of an act is divided into four distinct patient cohorts with sequential adjustments to the timing of that 22 or three and the duration of exposure to IB after terrorists and be the existing standard of care for patients with Cryptococcal meningitis.

Cohort one of the Enac study got under way early in the third quarter of this year and included 10 patients on active treatment, who initially received five days of Ivy Apatorsen, followed by nine days of map 22, or three to complete the normal 14 day induction period.

Thereafter patients continued mad 22, or three as maintenance therapy for an additional four weeks.

In October the enact DSMB be reviewed both safety and efficacy data from the first cohort of patients and unanimously recommended moving forward into the second cohort of 40 active treatment patients.

Based on our discussions with the principal investigator and given the vulnerability of this patient population, we believe that the DSMB be would need to see a combination of favorable safety and efficacy data in order to advance. This study to the next cohort we.

We are very optimistic as we head into cohort two where patients will receive only two days of Ivy EPS terrorists in before transitioning to 12 days of map 22, or three again, followed by four weeks of maintenance therapy, unmatched 22 or three.

We believe cohort two will provide even more insight on the potential for about 22 or three in this deadly disease.

Enrollment in cohort two is expected to begin shortly following local IR be approval and the D. SMB evaluation of data from completed cohort two is anticipated to occur by the middle of 2021.

We believe that as we consider the broader implications for that on both the development of map 22, or three as well as for the future of our LNC platform. It is important to provide some context on how an oral less toxic and well tolerated after terrorists and b could provide substantial.

Annual value to both patients and providers.

First I'd like to comment on the overwhelming preference patients have indicated for oral Matt 22, all three versus IB EMPA Terrace, and so far in an act.

The results of the first phase of an act were published in the journal of anti microbial agents and chemotherapy in September.

And highlighted that 96% of subjects preferred taking that 22 or three as compared to Ivy EPS Harrison.

Anecdotal feedback from the first cohort of patients in part two of Enac suggests a similar preference.

Second an orally administered less toxic and better tolerated formulation demand for terrace, and B would provide much more flexibility for treatment and can decrease the cost and complexity of care through reduced hospital stays fewer hospital acquired infections and most importantly.

Fewer air for terrorist and related side effects with less treatment limiting toxicities.

Our 2014 study reported that up to 85% of the cost of IB EPS Harrison associated hospitalizations for invasive fungal infections arose from managing side effects of this drop.

A better tolerated oral option could dramatically improve the patient experience could provide more options for treating disseminated fungal infections and could substantially reduce the cost of care associated with treating these deadly infections.

[noise] cohort progression in the Enac study is not only an important milestone for the development of that 22 or three but.

But also yet another critical step forward in validating the enormous clinical potential of our LNC platform.

The DSMB bees unanimous recommendation to move forward is a promising sign that our LNC formulation of after terrorists and B is both safe and potentially capable of crossing the blood brain barrier to deliver drug to an active infection in the brain.

This has important positive broader implications as we consider extending this technology to target other diseases and conditions were highly effective therapies may have significant drug delivery challenges and or treatment limiting toxicities.

Our LNC formulation of Apatorsen be represents a true gateway opportunity for both advancing the standard of care for patients with life threatening fungal infections.

And as a tangible demonstration of the potential significant and far reaching capabilities of our LNG platform.

With our recent cohort progression in an act and the anticipated de SMB evaluation in the middle of 2021, we're very close to delivering data, which could represent a transformational opportunity for mid teen this.

Turning next to Matt 25, a one which uses our LNC platform to orally delivered the broad spectrum and potent aminoglycoside drug application, which is commonly used to treat both chronic and acute bacterial infections.

We remain particularly enthusiastic about that 25, a one given its favorable profile and the significant unmet medical needs it potentially addresses.

For example, in oral less toxic and well tolerated amena glycoside would allow physicians to treat gram negative infections quickly and effectively without the need for late the hospital stays repeated infusions and debilitating side effects in fact, Matt 25, a one if approved would become.

The first oral I mean, it's like a site available to physicians and patients.

Matt 25, a one has been positioned for an initial indication for the treatment of non tuberculosis, mycobacterial lung disease or NTM.

NTM infections have emerged in recent years as an increasing problem to individuals with cystic fibrosis and other pulmonary diseases and they are increasingly resistant to most available antibiotics and becoming extremely difficult to treat.

Moreover, achieving adequate levels of drug in lung tissue is can be very challenging, especially in patients with cystic fibrosis.

Current therapies are limited and can be highly toxic to patients.

Matt 25, a one is formulated to address these limitations and provide the therapy, which is well tolerated orally bio available and demonstrate the efficient intra cellular delivery we.

We believe that once delivered into a cell Matt 25, a one is transported by sell directly into the long at the site of infection.

Resulting in efficient delivery and less toxicity, then observed with other treatments. This.

This profile is exactly what initially attracted the interest of the cystic fibrosis Foundation, with whom we have been working since 2016.

As previously guided we applied to the cystic fibrosis Foundation earlier this year to help support the continued development of map 25, a one and we expect a decision imminently.

In the interim we have reformulated and potentially improved about 25, a one from its first iteration and stand ready to commence a series of preclinical toxicology studies and the single ascending dose phase one study with this promising new formulation.

With the continued support from the cystic fibrosis Foundation, we plan to be in position to begin phase two in 2022.

We draw confidence from the clinical and commercial success of Insmeds Aric case, as we determine both the viability and large market opportunity for Matt 25, a one.

Eric case, which administers education through an inhaler was approved under FDA, new ALP had pathway, but.

But has significant limitations in the syndicated use including not being able to be used in cystic fibrosis patients.

Further it is accompanied by a comprehensive black box warning related to toxicity and the potential for serious adverse events in patients.

We believe that Matt 25, a one if approved would represent a significant improvement over Eric case, and other treatments for chronic pulmonary infections, giving patients and physicians in effective oral alternative in the fight against NTM.

And unlike our case, Matt 25, a one would also potentially be able to treat more acute bacterial infections like gram negative bacterial infections, which generally occur outside of the lungs.

Before moving to a discussion of met 9001, we would like to provide brief commentary on our broader ongoing LNC platform collaborations where we continue to make good progress. Despite the impact that COVID-19. This had on the short term strategic priorities of some of our collaborators.

We continue to work very closely with genentech in developing formulations of multiple molecules per our existing agreement.

We are encouraged by the limited data we have seen although we are precluded from commenting further under the terms of that agreement.

However, genentech recently approached us and extended our agreement for at least another year, which we believe is indicative of our progress to date and the continued enthusiasm shared by both organizations for the potential benefit our LNC platform technology can provide.

We continue to aggressively explore opportunities through the national institutes of allergy and infectious disease to utilize our LNG platform in the fight against COVID-19, and remain optimistic that we will be a meaningful participant soon.

Finally, as we advance, Matt 22, or three and Matt 25, a one and generate important clinical data. We continue to receive increased interest from potential partners on those assets as well as other potential applications of our LNC platform delivery technology, both inside and outside the United States.

We believe that a step establishing collaborations and licensing relationships on these assets, especially outside the United States could be a significant opportunity for muddiness in the coming quarters.

These discussions and relationships, obviously take time to develop and formalize, but we're very pleased with the interest expressed to date and the quality of the potential partners.

Now I will turn to Matt 9001.

As I mentioned at the beginning of the call. There are two very important milestones for our Mat 9001 program during the third quarter that are worth mentioning.

First we completed enrollment and enhance it our second head to head crossover comparative study of Matt 9001, our next generation prescription Omega three therapy versus placebo.

This clinical trial will directly compare Matt 9000 ones and the seapass effectiveness in reducing triglycerides and their effect on other important direct and indirect lippitt markers, such as PC EPS canine as well as blood levels of Acos append to Noah acid work EPA and other Omega.

Three fatty acids. This.

Despite the challenges presented by COVID-19.

We continue to expect topline data from this trial in the first quarter of 2021.

Given the complexity of the continually evolving Omega three market the ability to show differentiation and potential head to head superiority versus the SEPA is extremely important.

We believe we are in the final stages of exactly the right study at exactly the right time to again demonstrate the overall superior profile about 9001, tuba, SEPA and any other prescription only omega three including generic copies of those drugs.

Second following an end of phase two meeting and review of the official minutes. We believe we are aligned with the FDA on key next steps from at 9001 Phase three development program and the Bible five B two registration pathway for an initial indication to treat severe hypertriglyceridemia, which is patients with trade.

What's the right levels at 500 or above that.

The main agreed upon elements of a phase three program to support and then da filing include one approval to go directly into a phase three study without any additional clinical work to the requirement for a single 12 week study to support efficacy in severe hypertriglyceridemia.

And three flexibility in the totality of patient safety data needed to meet regulatory requirements for an NDA submission we.

We continue to evaluate several ways to both meet these requirements and to potentially provide additional data clinically differentiating that 9001 from other prescription Omega three drugs and we remain on track to initiate our phase three program for about 9001 in the first half of 2021.

As Amarin recently restated its commitment to continue to educate physicians on the benefits of EPA and to extend expand the market for the ciba and branded Omega threes in the face of generic competition. We continue to view, Matt 9001 has the potential best in class prescription Omega three.

Matt 9001 was designed with the goal of clear differentiation and pharmacokinetics and impact on direct and indirect lippitt markers such as triglyceride MPC EPS canine.

We believe that enhance it provides an important and near term opportunity to validate the results from our first head to head study and separate Matt 9000 want from the rest of the Omega three class.

I would now like to turn the call over to Keith Kosinski, Our Chief Financial Officer, who will discuss our financial results for the third quarter.

Thanks, Gerry and good morning, everyone.

Turning now to our financial results for the third quarter of 2020, the company reported a net loss attributable to common shareholders of approximately $5.7 million or three cents per basic and diluted share compared to a net loss attributable to common shareholders of approximately.

$4.6 million or three cents per basic and diluted share for the same quarter of the previous year.

Research and development expenses were approximately $3.3 million in the third quarter of 2020 compared to approximately $2.7 million in the same quarter last year.

The increase was due primarily to higher clinical development expenses and employee compensation.

General and administrative expenses were approximately $2.4 million in the third quarter of 2020 compared to the previous year's third quarter gene a expenses of approximately $1.9 million.

The increase was due primarily to an increase in head count.

Turning to our balance sheet we.

We ended the third quarter of 2020 with approximately $62.8 million of cash cash equivalents and marketable securities compared.

Compared to approximately $27.8 million at the end I am sorry at year end 2019.

This increase includes net proceeds of approximately $46.7 million from the company's public offering completed in January.

Based on current projections, we continue to believe that cash on hand is sufficient to fund operations into the first half of 2023.

I will now turn the call back over to Gerry.

Thanks, Keith in summary, Machinists has made important advancements in several key areas. There has been meaningful progress in cohort progression for Matt 22, or three in an act and this has also provided validation for LNC platform delivery technology. In addition by completing enrollment and enhance it and gaining climb.

30 in alignment with the FDA on our planned regulatory and clinical plan. Matt 9001 is now positioned to generate topline data in Q1 of 2021 and commenced our phase three study in severe hypertriglyceridemia soon thereafter.

We are laser focused on continued execution as our lead drugs, our lead drug candidate to advance in the clinic and we are excited about the growing momentum behind our LNC platform as we look forward to even more promising applications of this exciting new technology.

We believe that Matt 25, a one is poised to become our third clinical stage asset and we remain extremely optimistic about continued support from the cystic fibrosis Foundation in the near term mid.

The team this has never been better positioned operationally scientifically and financially with near term catalyst that potentially enhance the value we strive to provide to patients caregivers and shareholders.

And looking ahead to 2021 and beyond the topline data from enhance it we await the next the SMB evaluation regarding progression from cohort two cohort three and then act in the Middle of 2021, and we continue to generate promising data through our collaboration with Genentech. Finally, we are pleased that our strong cash.

Position provides the existing capital to advance all of our product candidates towards significant data readout, an inflection points without needing to access the capital markets for additional funds for the foreseeable future with.

With that we have reached the conclusion of our prepared remarks, and I will now turn the call over to the operator for Q and a session.

Thank you at this time, we will conduct a question and answer session.

I would like to ask a question. Please press star one on your telephone keypad a confirmation until indicate your line is in the question queue.

Press Star two if you'd like to remove your questions on the queue.

Participants isn't speaker equipment, it may be necessary to pick up your handset before question to star Keys, one moment, while we pull for our first question.

Our first question comes from Bert Hazlett with BTI Ji. Please proceed.

Thank you.

Two general questions. One is on meant 9001, Jerry Thank you for the description and looking forward to the head to head work upcoming in Q1.

Regarding the phase three study could you elucidate a little bit more about the size of the trial and then I think we all understand that primary endpoint, but could you also talk about maybe key secondary endpoints for that phase three trial in particular.

Sure. Thanks, Bert So just overall what that trial designed to do is to look very similar to the phase three trials in severe hypertriglyceridemia that the other prescription Omega threes have done just as a general matter.

It may not look exactly like Marine for example, which was the phase three that amarin ran with the ciba in severe hypertriglyceridemia.

And in our discussions with the FDA and our belief that the closer. These studies look the easier it is going to be to compare data. Although that's always a tough thing to do study the study.

It's going to be a better tool, we think to be able to determine the overall sort of impact that Matt 9001 has in this patient population, but dr. Ferguson one at you kind of walk through the design of the phase three study in the size of the Phase three study bird is designed to mirror what has gone before.

Or in the severe hypertriglyceridemia space the preliminary design is.

On the order of about 300 patients with 200 on active treatment randomized two to one active to placebo control is placebo controlled it will involve 12 weeks of therapy. The primary endpoint will be.

<unk> percent reduction in triglycerides from baseline.

And it's designed to address a population of patients with triglycerides greater.

500, the severe hypertriglyceridemia I think that this mirrors what has gone before it is a well trodden pathway.

The FDA is very familiar with this design of they were comfortable with the design for assessing the efficacy of the trial in terms of the active treatment.

And I think that it puts us in a very good position it will need to be run globally.

But we are already well along the path to hammering.

Hammering out the details of exactly what is going to be going into this trial.

That's very helpful. Thank you.

Okay, and then I have a separate question on the LMC technology side.

Fabulous progress on 22 or three in the cohort progression and.

Exciting developments with 25, a one as well as with your partners Genentech Gerry how do you think about the LMC platform kind of near term versus long term.

As you think of the capital within the company.

No.

Partnerships and validating partnerships versus internal development with this technology you could make a case for either or both or how are you thinking about strategically kind of near term and then longer term.

Yes, I think Bert I mean, I think biotech is about building were building value in building relationships number one and number two value you bill by advancing your own clinical candidates.

To meaningful inflection points in generating data, which can make those products a compelling opportunity for physicians and patients. So we believe we're accomplishing that with certainly with with Matt 22, and three and we look to aggressively push Matt 25, a one forward that being said, even with those two assets sort of.

Strategic collaborations on a global basis or in areas, where our development and commercial expertise wouldn't come into bear can be important validating sort of transactions those relationships take time, we have gotten a lot of inbound interest there and.

And so we will explore those especially outside the U.S, but fundamentally we believe the greatest value can be driven by pushing your own products forward, but because the LMC platform can be so broadly applied it does make sense to continue to investigate collaborations like Jeanette.

Tech, especially in areas outside of what we are doing right now in infectious disease, and where we can rely on big Pharmas expertise certainly with maybe more innovative cutting edge or newer areas of medicine than than we are exploring with our current small molecule products.

But you don't want to actually go too fast you want to be able to have the value catch up to the collaboration so that you can capture it but ultimately we just want to continue to drive and deliver that across the board, but but I'll also tell you I mean, I noticed that novo Nordisk paid 1.8.

Billion dollars for atmosphere recently, which represents a two and a half times multiple on MSP or is value and endpoints call that the Holy Grail of oral drug delivery.

I you know I think that the drug.

Fact of delivery of molecules, whether they be small molecules oligonucleotides proteins peptides continues to be a huge area of challenge.

We're enthusiastic about exploring the opportunity that the LNG platform could provide in all of those areas and a deal like Novo an atmosphere. I think provides validation for this approach and a reason to be excited as we continue to advance our own clinical candidates and expand our collaborations.

And with companies like Genentech.

Thats great. Thank you for the reminder of the proxy that de Novo deal and I look forward to more progress on on both.

Both business lines. Thanks.

Thanks Bert.

Our next question comes from Yasmeen Rahimi with Piper Sandler. Please proceed with your question.

Hi team I. Thank you so much for taking my questions.

Up three different questions. So the first one curious if you could kindly kind of walk us through discussions with partnerships in regards to the utility of the LNG platform. What is the type of checklist that partners are wanting to be performed before committing to work together so that might be.

First question and then the second one is on the phase three design on nine one can you comment on what the total safety data that you need to show.

In regard to filing and then I have a third question.

Nine unwind.

Okay. So we'll take the first question first so in terms of an overall checklist, yes, it really depends on the partner and on the therapeutic area in which you're looking to investigate for example for our first three announced collaborations there there was no checklist or history other than a review.

Of data that we had generated over time at the LLC platform in areas like small molecules or DNA plasmid or vaccines, which attracted the interest but that is why those collaborations sort of began with proof of concept the reality of.

The LNG platform is that it's not cookie cutter to the extent that the same way we would formulate ampere terrace. In for example is different than how we formulate advocation fundamentally they all fall within the umbrella of the LNG platform, but you're not necessarily going to be able to adjust quickly for.

Emulate from one sort of chemical molecule to another a lot of things make a difference there and thats even different with genetic test for example, so but as as we enter into collaborations with new pharma, who are interested in their molecules. The checklist is pretty simple.

Please formulate our molecule will give them a number of different formulations, which they will then test in a variety of preclinical models that Dolby assayed and then there'll be some in vitro study before you get to some in vivo preclinical studies. If for example, we are talking about something in the gene therapy space, but they're going to be.

Immediate tests on an in vitro basis on things like toxicity or protein expression. For example, that's can be a little different than what you would do with a small molecule for infectious disease.

But our belief is that upon these proof of concepts that we will then very quickly move into situations, where we're talking about a license does that take into account and option to license structure. We're open to a variety of structures there, but what were intently focused on now is delivering.

Solid formulations that can then be evaluated but I think Dr. Ferguson's can add something just to sort of take it to a very high level. What a partner is looking for is basically two things.

They are looking for can you make it and can you take our compound and can you deliver it and then.

Can you measure it because in the traditional drug development world. It is all about drug levels, but given the unique characteristics of our platform you have to be able to measure the effect and the simple question that.

A lot of these discussions revolve around is once we have established that we can provide them with confidence that yes, we can make a particular product and two we can measure the effect of that product if its an antibiotic if it's an anti viral if it's gene therapy, how do you measure that beyond the drug levels and those are.

The two boxes that really need to be checked.

Does that help on the first question yes.

Yes that was helpful. Thank you okay.

Okay. So question number two is about the phase three safety database and our recent interaction with FDA and at the end of the day, we are still in discussions with the FDA on the size of that safety database, but what I will say as during our meeting we talked exactly about the type of patients that would need to be included.

For an evaluation of safety and one of the important things that came out of that FDA meeting was a great amount of flexibility. This additional patient safety data does not need to be in patients with severe hypertriglyceridemia for example, or trxs.

Above 500 that obviously provide some challenge for recruitment and also would provide.

Some challenge in terms of running into our really our pivotal 12 week trial in severe hypertriglyceridemia. We do know that we will need to generate additional data in patients with elevated triglycerides, but that's also an opportunity for Matt 9001 to potentially show.

Show additional differentiation in maybe a different trig level patient population than in our phase three pivotal program. So we continue to engage with the FDA on that we expect to kind of have that answer at some point in the first quarter of 2021, but nothing will stop us from starting that.

At pivotal phase three study.

In severe Hypertriglyceridemia and then the addition of patients to satisfy the patient safety database based upon our current projections and our discussions with FDA, we will do nothing to change that timeline to end da filing so anything we do or anything we choose to do.

Two.

To satisfy those requirements will be able to be done concurrently with our planned phase three study.

Thank you Jerry and would you be can you comment on how you're thinking about adding let's keep our arm to that study and then also some comments around sort of manufacturing and supply chain on you now that could be also very helpful for assets that continues to be at major question among investors.

Okay.

Sure.

So in terms of adding an active receive arm, it's probably premature to comment on that and there is a lot of different things that we would evaluate but I would also say that we will now have after enhance it reads out we will now have done not one but two head to head studies versus the ciba, so the utility necessarily of adding up a SEPA.

Arm to a study that's designed to essentially only get you additional safety data. So you can file an NDA is probably a bridge too far.

I think we will we'll be comfortable that we will have assembled a very strong and unique head to head data set versus placebo from the two planned crossover studies, that's not to say that it has not been entertained but I would say that we were we are going to be more focused on generating data.

With Matt 9001 versus placebo.

And then in terms of manufacturing and supply chain, so well for us I mean, although we have a global supply chain. We have seen some impact from COVID-19, a lot. Some of that has to do with continued delivery of technical batches to kind of meet our CMC requirements.

To position ourselves to go into phase three but all of that is back on track. We continue to explore the opportunity to create redundancy from our current program.

We're confident in the amount of supply that we can get certainly for our entire clinical program and I think that you know well enough and in Amarin will talk while enough. There's certainly enough fish in the sea, what we're really sort of intently focused on and remember that we have our own proprietary.

Formulation for Matt 9001, and so it's really within our hands to then work with who are our key suppliers to kind of deliver that and then we go to a proprietary capsule technology. So this is a capsule technology that no one else has and.

And that we think is another barrier to entry so were comfortable on supply.

This is this is not an inexpensive cost of goods product I think thats one of the things that probably gives amarin, some comfort that and their relationships with suppliers of ico support ethanol probably gives them. Some comfort that this won't be an ordinary generic launch we are in an entirely different place.

We have more than enough supply, we have plans to add to that overtime and.

And so thats one area that we think we can continue actually to create.

Our own barriers of entry between now and when we anticipate that meant 9001 could be approved.

Thank you, Tom and Jerry and taking my question.

Once again, ladies and gentlemen to ask a question. Please press star one on your telephone keypad.

There are no further questions in queue at this time I would like to turn the call back over to management for closing comments.

Thank you. Thank you Latania and thank you to everyone for joining US today. We appreciate your continued interest in machinists and the team here looks forward to providing you with updates on our future progress have a great day and a good weekend.

Thank you. This does conclude today's teleconference. You may disconnect. Your lines at this time and have a great day. Thank you for your participation.

Okay.

[music].

Yes.