Q1 2020 Earnings Call
[music].
Welcome to the mid teens Biopharma first quarter 2020, <unk> results conference call.
At this time all participants are in listen only mode. A question and answer session will follow the formal presentation.
As a reminder, this conference is being recorded.
I would now like to turn the conference over to Peter Vozzo Investor Relations representative for mid teens Biopharma. Thank you you may begin.
Thank you Diego good afternoon, everyone and thank you for joining the machinist Biopharma first quarter 2020 results conference call just after the Mark to close today, we issued a press release with our first quarter 2020 financial results along with business uptick releases available on the between just Biopharma website under the investors section.
Speaking on today's call will be Jerry keyboard Chief Executive Officer, We also have Dr., Terry Ferguson, Chief Medical Officer, Dr., Terry Mcevoy, its chief Development Officer, who will be available to answer your questions. During our Q1 each session. At this time I would like to remind our listeners that remarks made during this call may state management's intentions hopes beliefs.
Stations or projections of the future. He's a forward looking statements and Bob Rich risks and uncertainties forward looking statements on this call are made pursuant to the safe Harbor provisions of Federal Securities laws.
Forward looking statements are based on the cleanest biopharmas current expectations and actual results could differ materially as a result, you should not place undue reliance any forward looking statements. Some of the factors that could cause actual results to differ materially from those contemplated by such forward looking statements I've discussed is a periodic reports machinist.
Biopharma files with the Securities and Exchange Commission. These documents are available and investors section of the company's website and on the Fccs website <unk>.
An archive of this call will be posted to the company's website also an investor relations section on companies prepared remarks, we'll open up the call for question answer session I'll now turn the call over to Jeff.
Thank you Peter good afternoon, and welcome everyone and thanks for taking the time to join US today is we provide a business update and discussed her 2021st quarter results.
We hope you in your families are safe and healthy during these challenging times.
The first and second quarters of 2020 will be remembered as very trying times in light of the unexpected personal and business interruptions brought on by this global pandemic.
In early March we along with the rest of the country and the rest of the world for that matter, we're thrust into uncharted waters.
I have to say I am incredibly proud of how them a team. This team has responded to this crisis recognizing the seriousness of Kobin 19, and acting early and decisively to address any operational challenges.
Thanks to our agile structure, we adapted very quickly to minimize disruption and prioritize the wellbeing of our employees study participants and research partners.
During the first quarter, we implemented a variety of mitigation strategies to reduce risk and ensure business continuity.
In line with the guidance from the U.S. Sen of disease control and prevention as well as the state of New Jersey.
We implemented work from home measure all employees and suspended all business travel.
We also implemented processes to ensure the advancement of all of our development programs, while continuing to emphasize the safety of our team and research and development partners.
Our lab employees recently returned to our Bridgewater facility and we are prioritized certain lab and manufacturing activities in the interest of safety and efficiency.
From a clinical study perspective, the cobot 19 pandemic is an ongoing challenge for all clinical sites in hospitals throughout the world.
As you know late in the first quarter, we made the correct decision to temporarily pause enrollment in each of our key clinical trials.
This decision was taken to ensure the health and wellbeing of trial participants and clinical site employees, while ensuring the integrity of our clinical trials as well as capturing all clinically meaningful data.
Since that time and as we have seen gradual improvement in many areas throughout the country and across the globe.
We have been working closely with our clinical trial sites and study investigators on plans to riddance resume enrollment of patients in our important clinical trials with the appropriate assessment and safety monitoring protocols in place I will speak more directly to this in the context of each of our clinical stage candidates in the.
Few moments.
For those of US at mid teen is the challenges posed by Cobot 19 served to highlight the critical needs of patients dealing with serious diseases.
We remain as committed as ever to our mission of serving these patients as well as the health care providers, who care for them.
We believe we are pursuing this mission from a position of strength and our solid balance sheet will enable us to stay the course with several meaningful inflection points anticipated over the coming quarters.
Our enhance a trial the head to head crossover comparative study of Matt 9001 versus the SEPA remains an important and compelling study for our next generation prescription only Omega three therapy.
We're thankful to be able to announce today that enrollment for enhance it is expected to resume in June.
And working closely with Dr., Kevin Mackie, our study director as well as the teams from each of our eight clinical trial locations, we are implementing all reasonable and necessary safety procedures for subjects and study monitors.
With enhance it expected to resume in June we are modestly revising our guidance for the delivery of topline data from the fourth quarter of 2020 to the first quarter of 2021.
While it's certainly remains possible that topline data could be available sooner depending on enrollment we believe that this slight revision and guidance is appropriate under the circumstances given some of the uncertainties around Cobiz 19.
Importantly, we remain on track for our end of Phase two meeting with the FDA in the third quarter of this year.
We are in the final stages of preparing both the meeting request and our briefing package, which will focus on the results from our comparative toxicology and human pharmacokinetic studies as well as our planned phase three protocol for the study of Matt 9001 in patients with severe hypertriglyceridemia.
The team has continued to do an excellent job of maintaining our supply chain for our Matt 9001 clinical trials without disruption, while taking steps to prepare actively for phase three.
We continue to believe that Matt 9001 has best in class potential in the prescription Omega three class.
Clear differentiation in pharmacokinetics.
Hey levels impact on lippitt markers, such as triglycerides, and Pcsknine and convenience of administration without the need to split dosing to more than once a day and having to be taken with meals.
We look forward to resuming enhance it and reporting the results from this trial as soon as possible.
I would like to turn now to Matt 22, or three our lead drug candidate applying our lippitt nano crystal or LNC platform delivery technology.
Before I get into specifics, however, I would like to spend a moment talking about infectious disease generally and the impact of the global pandemic on this area.
Interesting an unintended feature of covert 19 is the increased attention being given to the treatment and prevention of infectious disease.
Dealing with these hidden enemies, and the potential health and economic threats. They post to society has been thrust into the spotlight.
We are unfortunately, seeing the impact that cobot 19 has had on the emergence of other deadly infections, including invasive fungal infections emerging reports suggest that as many as one third of patients with severe cobot 19 infections were acquiring intensive care may also be battling life threatening and.
Piece of fungal infections.
In addition, we're also seeing the importance of drug delivery takes center stage as a critical element of effectiveness is ensuring that enough of a therapy can get to the afflicted area of the body at the right time.
We believe that our LNC platform is well positioned to not only become a solution for we purpose drugs like gamper terrace in B and am occasion, but potentially for a variety of new complex molecules in development, which required delivery in a direct and targeted manner with the convenience of oral administration, allowing for outpace.
Current treatment options and improved Pharmacoeconomics.
In Matt 22 or three.
Our oral LNC formulation of the broad spectrum and potent antifungal drug Ampla Terrace, and B. We believe we have the potential gold standard and drug of choice for the treatment and perhaps ultimately the prevention of deadly invasive fungal infections.
Building on extensive impressive preclinical data in the treatment of invasive fungal infections and two phase two studies conducted in the treatment of mucosal fungal infections, Matt 22, or three is currently positioned to investigate the treatment of Cryptococcal meningitis, a deadly in face of fungal infection of the central nervous system as.
We have previously announced at the end of March our enact trial met 22, or three which is financially supported by the National Institutes of health was temporarily suspended by mandate of the Uganda National Drug authority.
Today based on the latest available guidance, we announced that we anticipate resuming enact enrollment in June.
The significant unmet medical need of HIV patients in Uganda suffering from Cryptococcal meningitis is a key factor in restarting this clinical trial as soon as possible.
Following discussion with our clinical site in Uganda, we're planning to resume enrollment and treatment of the first cohort of 10 patients in the next month.
Given this updated timing, we would expect to be in position to make an announcement as to the progression from the first cohort of patients to the second cohort of patients later this year.
We continue to believe that cohort progression is significant with this drug in this patient population and an important potential value inflection point for this therapy.
We view Cryptococcal meningitis has an important and potentially valuable gateway indication from at 22 of three.
In the United States alone, where we believe Matt 22, or three could be eligible for a limited population pathway for antifungal drugs or telpad approval. There are more than 5000 cases annually with potential pricing of more than 50000 per course of therapy. According to peer companies who are performed.
Market research in this area.
In the US a drug approved under the L. pad pathway is an anti bacterial or antifungal drug approved to treat a serious or life threatening infection in a limited population of patients with unmet needs.
Of course, the incidence of invasive fungal infections, including Cryptococcal meningitis is even greater around the world, thereby expanding commercial opportunity potentially significantly.
Following approval and Cryptococcal meningitis, we believe that Matt 22, or three is well suited for streamlined five will probably be two approvals in other indications.
This could position, Matt 22, or three to become the antifungal drug of choice for the treatment of many invasive fungal infections.
Total sales for drugs treating invasive fungal infections amount to several billion dollars, which speaks to the great potential format 22 or three.
Which we believe could capture a very large share of this market if approved Matt 22, or three would give physicians for the first time the ability to safely utilize the most broad spectrum and highly potent antifungal drug currently available to treat invasive fungal infections with an oral formulation.
In the first quarter of 2020, we also made progress with another clinical stage asset supported by our LNC platform delivery technology.
Matt 25, a one is our oral formulation of AMA kaysen, a broad spectrum I mean, the glycoside, commonly used to treat chronic and acute bacterial infections.
Important work on Matt 25, all one which was supported by a grant made by the cystic fibrosis Foundation.
Gilded promising preclinical data, which now potentially positions this drug candidate for further development.
We are in an ongoing dialogue with the cystic fibrosis foundation to support development through phase two.
And in the first quarter received a small bridge grant commitment to continue important preclinical work on this product.
Given our currently allocated resources, we would rely upon the cystic fibrosis foundation and its support to advance the struck.
We are optimistic given our discussions today and look forward to hearing back in our application in the second half of this year.
We believe that Matt 25, a one has significant clinical and financial potential.
We are keenly aware of the value that ends med a $2.4 billion market cap company has been able to create within inhaled version of application, which was approved in 2018 under the L. pad program, but with a very limited approval accompanied by significant black box warnings related.
To safety.
We believe the profile from at 25, a one suggests it could be far better tolerated than insmeds their case, where most of the serious adverse events are caused by having to inhaled that product.
As the treatment and prevention of infectious disease continues to receive overdue attention. We look forward to the potential to advance met 25, a one which would provide a much needed and much better tolerated solution for patients battling pulmonary bacterial infections.
We are frequently asked about the progress we are making on some of the collaborations with big pharma that we announced during 2019.
I am pleased to report that all three of these announced announced projects remain ongoing, albeit with some interruption from coated 19.
We have advanced our Viiv healthcare collaboration to the point, where we are preparing to provide formulations for preclinical investigation.
We are also in the process of working on a variety of projects with Genentech just to provide a few examples.
Our hope is that early data from these relationships could be available later this year.
Furthermore, now that there have been demonstrations of efficacy for Ivy or injectable therapeutic options for the treatment of coated 19, our discussions with the National Institute of allergy and infectious disease at the NIH and others have intensified as we identify opportunities to apply our proprietary.
LNC platform to these compounds.
Our goal would be to formulate well tolerated and viable oral therapies for patients confronting cobot 19.
While these discussions are ongoing there is obviously a sense of urgency on all sides and we look forward to potentially playing a very active role and providing appropriate updates as they materialize and become available.
Turning now to our financial results for the first quarter of 2020, the company reported a net loss attributable to common shareholders of approximately 5.2 million or three cents per basic and diluted share compared to a net loss attributable to the common shareholders of approximately 4.3.
Billion or four cents per basic and diluted share for the same quarter the previous year.
Research and development expenses were approximately 4.1 in the first quarter of 2020 compared to approximately 2.3 million in the same quarter last year.
The increase was due primarily to higher clinical development expenses related to the development of Matt 9001 at 22 or three.
General and administrative expenses were approximately 2.3 million in the first quarter of 2020 compared to the previous years first quarter DNA expenses of approximately 1.8 million. The increase was primarily due to higher employee compensation costs.
Turning to our balance sheet. We ended the first quarter of 2020 with approximately $71.2 million of cash cash equivalents in marketable securities.
Compared to approximately $27.8 million 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 believe that cash on hand is sufficient to fund operations into the first half of 2023.
This is extremely important as we advance our products toward potentially significant an inflection points.
The cash runway that extends almost three full years and well beyond these inflection points provides great security during and otherwise significant period of uncertainty for many companies.
We are extremely pleased that we were able to be opportunistic in the first quarter and conclude in important financing to protect the company and drive our business strategy.
In summary, overall, we are in a strong position from a business continuity standpoint, and I. Thank my teammates for this and commend them for their continued dedication and drive as we all work together to get through these uncertain times.
We remain committed to achieving the milestones we laid out at the beginning of the year and reaching our overarching goal of developing important therapies for areas of critical need.
I am proud of the tremendous progress we have made in these uncertain times and I'm confident that we will continue to adapt as circumstances evolve.
We all remain very excited about what lies ahead for the company for the remainder of 2020 and beyond with that we have reached the conclusion of our prepared remarks, and I will turn the call over to the operator for our question and answer session.
Thank you.
At this time will be conducting a question and answer session. If you would like to ask a question. Please press star one on your telephone keypad.
A confirmation Tom will indicate that your line is in the question Q.
You May press Star followed by the number two if you would like to remove the question from the Q.
Call participants do think speaker equipment and may be necessary to pick up your handset for pressing the star keys.
Our first question comes from Bert Hazlett with BTG. Please state your question.
Yes, thanks, one or two.
Thank you for the update on 25 a one.
Sure would you be kind enough to give a little bit more on the gating items for advancing that program for work.
Sure. So just bird based upon our cash runway, our projections and our operating plan for Matt 9001, and Matt 22 of three.
We've allocated our resources to those two lead drug. So why we have continued to do formulation work and minor work necessary to position that drug to advance we do believe that advancing 25 or one.
Further into the clinic, we've already completed one single ascending dose.
Phase one study for that drought, but going further into the clinic will rely.
It to a great deal upon that with the support of the cystic fibrosis Foundation. So we are we are optimistic given our the level of our conversations there. The data that was generated using their funds was submitted directly to them and caused them to reach back out to us to invite us to suspended.
The postal for additional funding we responded aggressively to that given the interest we have in that product and the potential addressable market.
And so we're optimistic that that will result in something but advancing that product will be dependent upon their support.
Great. That's very clear. Thank you just two more for me you expanded number sites for enhancing could you just talk a little bit about though of the additional sites you chose and why clearly makes sense and then the second one would be what types of data should we be.
Okay, we expecting out of the additional collaborations from Genentech and the.
Thanks.
So I'll just first talk about site expansion so.
Even pre covert 19, one of the things that we looked at as a team.
Was really giving ourselves the best opportunity to deliver data in a timely fashion.
We knew the importance of 2020 any enhance it study and being able to use enhance it as an opportunity to further differentiate our product from the seep up and the importance of adhering to timelines and so we begun.
Even in the first quarter addressing the possibility of adding additional sites, mostly as a way to ensure timely delivery as we began to recognize and realize the risk that cobot 19.
Provided we actually accelerated those discussions and we actually have assessed our sites on the number of different levels. There is a level of sophistication, we bring to that obviously, we had a number of sites before but we also have taken a look at.
How the demographics and the epidemiology of this virus is occurring across the country and so as we evaluated the opportunity to bring on different sites. We also tried as much as possible based upon available.
Evidence to select those sites in areas, we believe would be less severely impacted than others by cobot 19. For example, we didn't choose Nate site in Manhattan. So.
That was one of the reasons.
We added eight sites was to make delivery more timely and then also to give ourselves some opportunity should there be coming issuer are challenged with enrollment in any of our AIDS any of our six sites that we would have additional sites to pick up the slack.
And then.
So and then you asked a question on the collaboration so every one of our collaborations with Big pharma is about proof of concept.
It is about taking their molecule developing formulations, and then providing those formulation back to big pharma, where they can do early preclinical proof of concept studies those studies and the type of studies will depend on the molecule and the target some of those will be in.
Active disease models are there will be in models to determine things like protein expression. So when we say that were teen things up with Viiv healthcare. That's what we're we're doing we're giving them the formulations, where they then we'll go and do their preclinical.
Work, we have not disclosed publicly nor are we at liberty to disclose publicly what those targets are how those models. These those formulations will be evaluated.
Same thing with Genentech, there's just a number of molecules that we're looking at but at that same early stage.
Evaluations, so we need to be careful we think theres, a great opportunity and partnering with big pharma, we like the ability to utilize their expertise in molecule development and their expertise and financial resources to broaden the application of the technology, but but we did not like we're going to turnaround and all of a sudden there's.
Going to be human clinical data. This is early now things can happen fast once you have proof of concept, but for us it's kind of getting to that first level and thats, what we would hope to see from Viiv healthcare and origin and tech in the second half of this year how that timing.
He is disrupted by covert 19, and how it impacts their operations, we have not seen that yet theres always the opportunity that that could impact them, but it's that sort of data that we would be looking at from them.
Okay. Thank you very much for that.
Thank you. Our next question comes from Ted Tenthoff with Piper Sandler. Please state your question great. Thanks very much.
Turning things for the up in Atlanta rooms, as well and thanks for your comments.
What do you sense, just with respect to the reason.
Patent rulings with respect to the seat.
So to how that changes the dynamics in the market obviously the rack.
Impact from the answers or what.
Let's look, but just wanted to get it kind of high level.
How you anticipate that could actually impact the market. Thanks, so much.
Thanks, Ted I. Appreciate the question is certainly a lot's been made up of Amarins latest challenge with respect to the IP I mean, we've set our piece in terms of it doesn't impact us at all I think it's too early to tell how if at all it impacts the market. Obviously, there is an appeal process.
That they will go through to date this year based upon Amarins disclosures.
First quarter sales and things like that it hasn't seemed to impact them.
At all nor has it changed their plans for how they are going to.
Try to continue to expand the market.
Maybe there's some some reduced DTC costs, there, but based upon the addressable patient population that is subject to the new labeling of the SEPA. This market is going to continue to expand and so I think we need to kind of wait to see how that is resolved.
From a litigation standpoint, before you're able to really see.
How this is going to impact the market, but one thing is clear, it's it's not going to impact a product that's differentiated from the SEPA or its opportunity to become a best in class drug. So why we believe that the headwinds that amarin has faced has had an impact.
On our stock.
Ultimately are the success of Matt 9001 will be judged by how its differentiated from deceived by that's one of the reasons why enhance it is so important it gives us that other opportunity to distinguish Matt 9001, and it's unique benefits on things like EPA levels on Pcsknine that would be.
In addition, it as potentially a superior drug to perceive and any generic copy. So for right now the market continues to expand we do know that people have some concerns, but I would say that those concerns really rest with amarin its market cap and its ability to fulfill its analyst projections for its sales supporting.
Its valuation for US we think the pastors are very green and the opportunity to differentiate is still there.
Thanks, That's super helpful perspective, they're really looking report to the intensity them now early next year.
Thanks Ted.
Thank you and just a reminder to ask a question at this time press star one on your telephone keypad.
Sure move your question from the Q Press Star followed by the number two.
Once again to ask a question press star one on your telephone keypad.
Our next question comes from Jason Mccarthy.
With Maxim Group. Please state your question.
Hey, Gerry Thanks for taking the question I think.
I would agree that with all the Corona virus activity that's going on.
Not a bigger light shining on non infectious disease and there is right now.
Can you talk a little bit about how maybe that shift some of the.
Fundamental direction of machine if it does it all tore it to 203 and also help us understand a little bit more about the market opportunity because antifungal alone or 4 billion, but.
Ambisone as the after Terrace and leader, it's it's 500 million, it's a fraction of that probably because it's not used because of toxicity as much as it should be.
And then there's a whole market thats on caps and just prophylaxis.
And treating patients on different hospital wards. When you don't know why they have a fever. They use the kind of candidates right. So there is this whole 4 billion dollar opportunity and all these dynamics behind it. So maybe first a little bit machinists is thinking and then a little bit about the market dynamics.
Sure.
So Jason Thanks for those questions first there is no fundamental shift.
To our focus in inside this company and even over the last 12 months, we have talked about the importance of having to clinical stage assets.
The interest in those assets in the markets in which they participate will invariably ebb and flow based upon an investors view of the upside potential in any one time, but the way we look at Matt 9001 is no different today than it was a year ago. We continue to believe that the profile of that drug suggest.
That it's an asset that we should support with a significant amount of our resources. We are in the beneficial position of having a partner in the NIH, who today has underwritten a lot of the expense in developing that 22 or three and that continues with the enacted trial. So moving forward we are intent on getting.
To what we view as the potential for transformational data for both Matt 9001, and Matt 22, or three and less than 12 months. So this is not going to be a situation.
Like perhaps investors saw in 2015, where because of the headwinds facing the Omega three class in amarin at that time and due to our available resources. We made a strategic decision to Placemat 9001 in our back pocket and advanced the platform.
In 2020, what you have is situation, where now it's not headwinds, which is facing any particular asset, but yes, perhaps due to the increased attention on infectious disease because of something like cobot 19, there are now tailwinds behind assets like Matt 20.
Two or three behind 25, a one and behind the potential of our delivery platform to potentially become part of a solution for covert 19. So this is not going to result in any sort of fundamental shift, but it does give us an opportunity to now instead of driving that nine down.
2001 forward with a lot of investor interest and dragging that 22 or three in the platform behind.
With governmental support perhaps now because of the need because of the attention and because of the increased resistance to available therapies and the real threat and scare we have now to two public health into the economy because of infectious disease, it's going to give us, we hope and opportunity to drive both of.
These things forward.
In terms of the antifungal market, you're exactly right I mean, Amazon with its global sales of around $4 million to $500 million is severely limited because of its toxicity. The broad spectrum nature of that antifungal drugs and the fact that as a poly in its uniquely.
Resistant to kind of developing resistance because of the way.
That its chemically formed it's the toxicity and the IB administration, that's held that back, but we need to progress development of this lockstep.
Cryptic Taco meningitis is a great initial gateway indication for us.
And should we be able with the enact study to follow up on the preclinical data showing that we could cross the blood brain barrier and effectively treat cryptic Taco meningitis should we begin to see that in the first second third cohort of patients from an act because of physicians familiarity with an for terraces and really the.
Only hesitancy they have is because of that toxicity I mean, we feel with the NIH patients that have been taking this drug for almost three years. We've established a very good safety profile, we obviously need to continue to add to that safety database with an act, but an amputation you do have that potential to take a report.
This medicine and solve its biggest challenges with Ivy administration, and toxicity and make that oral and well tolerated. So we do think that it is less of our hurdle for physicians to take a tool that they know really well from a potency and an efficacy perspective, if given the opportunity to.
Show that it's safe and well tolerated, they're going to use it so.
We do note that the global.
Invasive antifungal market is a multibillion dollar market, we're beginning with Cryptococcal meningitis, we're going to be we designed the study very carefully dr. mackiewicz and her team.
With that primary goal of patient safety designed as a trial that we think accomplishes a number of things, let's get without putting patients at risk efficacy data and let's get a dataset would shows we can cross the blood brain barrier. So we plan to take that lock step, we do think that the opportunity exists for Matt 22, or three to be used more broad.
Really.
But we need to get through the enact study before we can start to really think about how this can blossom.
Great. Thank you Jay.
[music].
Thank you. Our next question comes from Greg Fraser with Suntrust. Please state your question.
Yes, Thanks, Gregg Gregg Gilbert just wanted to pull up on the bridging study in the comparative Tox study I'm, assuming you would have called out at 30 findings that running expected. So you just comment on that that would be helpful.
Sure So Greg worst at why the all of the Inlight portions of those studies have been done I mean, we've seen some preliminary PK data there were waiting for final study reports.
None of that is eventually will be published in a scientific journal at some point, we really view this really as material that the FDA just wanted to see and it's a valuation of the relative profile of Matt 9001 to low base under five on five be to nothing that we've seen to date is surprising.
To us relative to what we understand the pharmacokinetics to be of a free fatty acid versus and FLS stir we've seen that work having been done in the past for example, with Epanova, having been compared to low base in the eclipse style in the Eclipse studies nothing surprising there, but ultimately it will.
Come down to how the FDA evaluate that data in light of low base and their comfort level with advancing us to phase three based upon that but based upon our teams significant amount of experience in this space having looked at the data from all the Omega threes, regardless of molecular form over the last 15.
In years.
We're comfortable with what we've seen so far and believe it continues to support our intended regulatory pathway.
That's helpful and as you work on the Street protocols and meet with the agency you won't yet data from enhance it I know that yield is planned to be ready to see before you had that data.
So it hasn't changed but can you just remind us how enhance it could influence your phase three plans if at all.
So it's an interesting question I mean enhance it is really done with an eye towards differentiation from a commercialization perspective.
It is not any sort of gateway for items that would impact the well established pathway to an approval in severe hypertriglyceridemia. What it does provide is an opportunity for an additional discussion with FDA, perhaps in connection with the eventual revelation of the street.
Data.
For what opportunities outside of severe hypertriglyceridemia.
I would be would be appropriate format 9001, so and it also gives us additional patients obviously to include in our safety database for submission as part of it approval for severe Hypertriglyceridemia and I'll, let dr. Ferguson comment here theres, nothing necessarily per se and enhance it.
That would advance severe hypertriglyceridemia, but it's really important data in a reduce it like patient population against a therapy. That's delivered compelling data so from that standpoint, it's good for differentiation, but Terry Ferguson anything you want to add to that.
Jerry mentioned this doesn't affect the severe hypertriglyceridemia strategy at all.
That path has been very well trodden is fairly well is very well laid out.
I think that the questions that finally, having the strength data will tell us will address other populations other indications and I think that from my own standpoint. The most important questions are going to revolve around the populations and subgroups in whom.
Work in whom it may have not worked to set the stage for future opportunities.
Got it thanks very much from just a couple of quick ones on the net.
Our Q2 or three exposure deferred during reduction beauty for the subsequent cohorts is the maintenance treatment stays the same for all the cohorts. Thank you.
Sure ill, let dr. mackiewicz comment on that.
So it's an.
Active control standard of care parallel group comparison.
Sequential cohort designs in which we are slowly tight treating patients off of the Anthony parents, and two well, Matt 22 or three.
Until ultimately in the fourth cohort we are on an all oral regimens about while amputation product. So the active arm will be the standard of care IDN to carry simplify that see with the test time being at product being administered for longer and longer treatment durations do sequential.
Cohort design in order to manage patient safety.
The maintenance phase induction will be a two week length of treatment time, followed by up to six weeks of maintenance treatment during the consolidation phase IV treatment.
Thank you.
Thank you our next question comes from.
Had messer with Needham and company. Please state your question.
Great Good afternoon, and thanks for taking my question.
I was just wanting to be upcoming into phase two meeting with the FDA.
In terms of your discussion of the phase three protocol.
You talked about it a little bit to whatever extent is appropriate that you could you maybe discuss a little bit more about what you are hoping to get out of that.
So after the end of phase two meeting there's really two aspects.
We view. This meeting one is you were giving FDA the data it asked for.
Before we could advance to phase three so based upon the feedback the written feedback that we got from FDA, what they wanted to see was a comparative.
Pharmacokinetic study to low beta and at 28 day comparative toxicology study so what we did.
In addition to those two we added a 90 day comparative toxicology study as well so the in the FDA mind their ability to have us past the phase three is going to be about their evaluation.
The safety of our product and have we established enough.
In order to move forward under five if I'd be two relative to low base. So so thats goal number one.
And based upon precedent and other products, which have pursued a five of IP to path to Lubys in this category, we feel pretty good about that.
And then in terms of the review of the Phase three protocol. This is a protocol, which they have seen.
Over and over again in this space in terms of an approval for severe hypertriglyceridemia. So you're looking at a 12 week placebo controlled trial in patients with triglycerides 500 or above that will be conducted on a global basis.
Versus placebo and so it is a protocol that will not come as a surprise to them. It's one they've seen.
Very often in fact with every other product that has been approved in this space.
And so those are the two boxes were hoping to check.
The evaluation of that data and then they are green light on that protocol, we have already begun sort of outlining preparations for phase three we've obviously accumulated the right sort of global talent on our SCB to be able to lead that effort, but thats really the goal going into the meeting Chad Thats, what the briefing book will focus.
Right on and we're hoping to come out of that meeting with an approval to go into phase three FDA.
For those who have experience in that area. They are not likely to say youre nay on fiber five be too. During this meeting they always make those sorts of things are review issue.
So the green light to go into phase three really is the key and our goal and expectation is that we could be in position.
To to enter phase three in the first half of 2021.
Great. Thank you very helpful.
Ladies and gentlemen, there are no further questions at this time I'll turn it back to management for closing remarks. Thank you.
Great Diego Thanks, Thanks to everybody for joining US today, we wish everyone continued good health and safety and we look forward over the course of 2020 to continue to keep you apprised as to our progress we're thrilled to be in position.
To resume both in act and enhance it.
In June of this year, and we look forward to the potential clinically meaningful data that each could provide.
Thanks for joining us and have a great day.
Thank you. This concludes todays conference all parties may disconnect have a good day.