Q2 2020 DURECT Corp Earnings Call
[music].
Greetings and welcome to the direct Corporation second quarter 2020 earnings Conference call. At this time, all participants Arnie listen only mode. A question and answer session will follow the formal presentation.
Anyone should require operator assistance during the conference. Please press star zero on your telephone keypad. As a reminder, this conference is being recorded I'd now like turn the conference over to your host Mr., Mike Aaron Berg.
Chief Financial Officer. Please go ahead Sir.
Good afternoon, and welcome to our second quarter 2020 earnings Conference call. This is Michael Linenberg, Chief Financial Officer of direct Corporation.
Provide a brief review our financial results, then Jim Brown, our president and CEO.
On a program.
Well then open up the call for a question and answer session.
Before beginning I would like to remind you of our safe Harbor statement.
Of course of this call we may make forward looking statements regarding direct products in development expected product benefits product development plans future clinical trials projected financial results.
These forward looking statements involve risks and uncertainties, which could cause actual results could differ materially from those in such forward looking statements.
Further information regarding these and other risks can be found in our SEC filings.
Putting our 10-K, a 10-Q's under the heading risk factors.
Let me now turn to our financials.
Total revenue in Q2, 2020, 25.8 million compared to 4 million Q2 2019.
You too included the recognition of 23.1 million and deferred revenue from the 35 million upfront fee and initial milestone payments associated with the termination notice about Gil arguably out agreement.
This 23.1 million in revenue is nonrecurring and has no cash flow and.
Excluding the recognition of deferred revenue collaborative R&D and other revenue for Q2, 20 $21.4 million compared to Q2 2019.
Primarily due to reduced development work on the Gilliat project.
Product revenue from the sale of all that pumps LACTEL polymers.
2.5 million Q2, 2020, compared to 2.3 million in Q2, 2019th.
I should note that we saw drop off and all that revenue in April and May compared to historic levels as many of our outside customers saw their operations affected by the Corona virus.
But then June with a more normal.
The gross margin for the combined product lines for 61% in Q2 2020.
These product lines continued to be strongly cash flow positive.
R&D expense was 6.7 million in Q2 2020, that's compared to 6.6 million from Q2 2019.
Primarily due to higher expenses for the view on actuate.
Graham, partially offset by lower expenses than most other programs.
That's DNA expenses were 3.4 million for Q2 2020, that's compared to 3.3 million in Q2 2019.
Our underlying blend rate during the quarter with 7.4 million.
In Q2, we raised 6.2 million that's of expenses from using our ATM facility by selling 2.6 million shares at an average price of $2.45.
Subsequent to the ended the second quarter, we've raised an additional 2.2 million net of expenses under our ATM facility, that's telling about 1 million shares at an average price of $2.30.
At June 30, 2020, we had cash and investments are 51.3 million compared to 52.5 million at March 31, 2020 64.8 million at December 31, 20 <unk>.
With that thanks again for joining our call I will now turn the call over to Jim for an update on certain of our program.
Thank you Mike Hello, everyone. Thank you for joining us today I hope that you and your families are all doing well.
That's correct, we're very fortunate to have an amazing dedicated group of employees, who continue to a Bachelor programs and keep our business is functioning at the highest level.
During the quarter, we made progress on a number of fronts.
We continue to advance the do you want actuate phase to be H. trial and are poised to initiate dosing in the coming much of this year.
We received approval from the FDA conducting a phase two trial do you aren't actuate and hospitalized scoping 19 patients with acute liver for kidney injury.
And we reported positive topline data from our 65 patients four week Nash study Dior nitrate.
Lastly, we continue to work with the FDA on deposits for India.
You are nitrate.
Isn't epigenetic regulator the modulate the expression of multiple clusters. The master genes that are involved in many important cell signaling pathways.
You are actuate I've forgotten regulates more than 1000 gene involving functions that include stabilizing mitochondria, reducing the put toxicity regulation of inflammatory or stressed responses and promoting cell survival.
I will begin with an overview of the opportunity for de ornate you wait and alcoholic hepatitis or H.
There are 117000 hospitalizations per year in the U.S. for age.
There are no approved therapies for H.
We had 100% you Bible a day 28 interface to A.H. trial Ministry local 28 day mortality rate for H is 26%.
We now plan to initiate and actually phase to be H <unk> placebo controlled efficacy trial in the coming months of this year.
The primary endpoint will be survival, which could enable ethnic celebrated regulatory pathway.
We have the potential to submit the NDA. After this phase to be H. trial, if the study demonstrates a robust survival benefit.
Approval after a single trial, it's not uncommon.
In fact, 37% new drug approval between 2005 in 2012, but based on a single pivotal trial.
And 42% of new drugs launched in the United States in 2018 were approved based on a single trial.
Hey age isn't a coupon alcoholic liver disease.
It is characterized by long term heavy intake of alcohol.
A recent period of increased alcohol consumption or binge drinking.
John This fever, the key weakness nausea, and vomiting lots of appetite and the depressed or negative mental state are all associated with age.
The American Association for the study of Liberty D guidelines provide the following criteria for the diagnosis of age.
The onset of jobs within the past eight weeks.
Ongoing consumption for at least six months of more than 40 grams of alcohol today for a woman or 60 grams about holiday for a man.
Also less than 60 days of abstinence before the onset of jaundice.
They also typically have elevated liver enzyme and ability we have been greater than three milligrams per deciliter.
Put this type of alcohol consumption into perspective.
This means approximately three scatter drinks per day for a woman and for for a man said the last six months, a 12 ounce beer glass of wine well, one and a half ounces at spirits is one standard drink.
If you think this disease does not affect people you know you're wrong.
One of our thought leaders, whose liver specialists in New York City told me a large portion of his age patients work for investment banks.
Additionally, about 20%, a b H population or in their twentys and Thirtys and may not have cirrhosis.
89% of hospitalized h. patients have insurance.
As I said earlier, there are no approved treatments for age.
What physicians or have available to them today, it's supportive care, which primarily involved abstinence nutrition and hydration.
And analysis of 77 studies published between 1971, and 2016, which included data from more than 8000 patients.
So the overall mortality from age was 26% at 28 days.
This high one month mortality rate is equivalent to.
M.L. for advanced breast and pancreatic cancers.
Do I, maybe used according to the A.S.L.D. guidance. However, steroid have shown only minimal benefit in clinical studies and may increase the infection rates and h. patients.
In the stop H. trial for.
STOPAH.
A study of more than 8000, h. patients steroid significantly increasing its actually right.
It's still for trial also convincingly demonstrated that steroids did not improve survival over supported care at 90 days or at one year.
Many h. patients are not eligible for steroids in fact, according to one recent study less than half of the severe h. patients are eligible for Stuart you.
We've been conducted market research on age and one Gastroenterologist gave the following coke regarding the use of corticosteroids, an age and I quote.
There's a clue lack of treatment options out there prednisone doesn't work.
We're still giving it because that's what we've been talked you do.
I want to see something that works that isn't a steroid doesn't cause infection and does it need to be taken every day and cool.
Regarding the Pharmacoeconomics the age hospitalization costs of H R.
Our more than $50000 per patient in the first year.
Alcoholic liver disease is becoming a leading cause of liver transplants in the U.S.
The cost of liver transplant exceed $800000.
As I mentioned earlier, 89% of hospitalized h. patients are insured.
Regarding hospital stay an age.
Each patients are just our discharge when they no longer have critical conditions that require in patient care.
Indeed, do you aren't actuate phase two A.H. trial 14 of their 19 patients were discharged in less than four days after receiving only a single IB infusion of do you are nine to it.
In our phase two way study of Dior nitrate it patients where they H all of that 80 patients. Instead. He survived through the 28 the follow up period of the trial.
Well be 19 patients were classified as severe based on their meld scores and 15 to 19 were classified as severe based on a scoring system that is specific to age.
This is the badri discriminate function score.
Do you on actuate was well tolerated by all the patients that all the doses evaluated in study, including the severe h. patients.
There were no serious drug related events reported.
Hey, each patients have greatly elevated gabelli with level.
The minimum probably wouldn't level to be diagnosed with age is three which is nearly three times the upper limit of normal.
The patients in our trial had an average Billy would have over 40.
Significant early that is by day seven reductions ability on the levels from a baseline or at a critical factor in determining a patient's prognosis <unk>.
Each patients treated with deal and actually in our study had significant day seven reduction did believe it.
Well, ignostic scores, including legal and meld as well I fear, yeah at any level and I NR. We're also improved in the study.
Based on our successful phase two A.H. trial, where we saw 100% survival of the H. patients and early hospital discharge. Despite the high historical mortality rate, we are advancing toward what we hope will be a pivotal trial in severe h. patients.
Yeah, finalizing the protocol and preparing to initiate this phase twob trial IDR nitrate into their age patients.
This will be a double blind randomized placebo controlled multicenter international phase Twob clinical trial.
Patients in the trial will be randomized to receive 30 milligrams or 90 milligrams of do you are not to eight or placebo.
The primary endpoint will be survival.
We plan to initiate dosing in the coming months of this year.
We expect that if we achieve a robust survival benefit this study based support the India filing.
Further details of the trial design, including the size of the trial and the details on the various endpoints will be provided one we initiate the trial.
Next I will update or the do you aren't actuate phase two trial in hospitalized cobot 19 patients with acute kidney injury.
Let's review the rationale for investigating the potential or do you aren't actuated the treatment of hospitalized cobot 19 patients.
You are not wait is not an anti viral age it isn't naturally occurring epigenetic regulator that has tremendous potential to treat acute organ injury.
30, the systemic inflammatory responses that lead to sepsis.
They used to a clinical evidence in patients with acute alcoholic hepatitis and preclinical evidence in multi organ injury models, which demonstrate protection of the lungs liver and kidney suggest beyond I too late may be beneficial to covert 19 patients.
Patients with severe coking 19 can develop in addition to lung injury and acute respiratory distress syndrome or a rds.
Multiple organ injury, including acute kidney liver Android cardiac injury, resulting from the viral infection EMEA overreaction to the infection or other complications.
These may contribute to poor outcomes in patients who cover Nike.
Study have reported that more than 60% of hospitalized patients with koby Nike have acute liver injury and more to 36% have acute kidney injury.
You are not Kuwait has the potential to treat the injury to kidneys liver and lungs caused by the infection with covered 90.
From a safety perspective, you are actuate has been well tolerated nearly 300 subjects, both healthy volunteers and patients in multiple phase one and two study.
Most relevant because in my team are the results from our phase two study of Dior nitrate in H. patients as I described earlier, all 19 patients treated with you on actuate survived the 28 day study, while the one month mortality in age patients who on average 26%.
Besides multi organ injury, what are the main complications associated with the death of H. patient similar to patients with Coca 19 is sepsis.
Therefore, if acute organ injury could be affected be treated or prevented and hospitalized patients with Coca 19 lives could potentially be safe.
This phase two trial is a double blind placebo controlled multicenter study to evaluate the safety and efficacy do you are not too late in coping 19 patients with acute liver kidney injury.
This study is intended to be an 80 patient trial with a three to one ratio of active took us either.
The dose of your nitrate will be 150 milligrams by intravenous infusion on day, one and for.
The primary efficacy endpoint is a composite of survival and being free of acute organ failure.
They 20 it.
It is our hope that Dior nitrate in combination with the standard of care will be able to help cobot, Nike patients with acute liver or kidney injury, which if successful ultimately can stabilize somebody's patient.
We are starting up clinical sites in New York, New Jersey, Chicago, Detroit, Southern California, and other sites around the country, where the disease is spreading.
Next I'll provide an update on the view on Actuate Nashville Grant.
In May of this year, we reported positive topline results from our phase one be trial do you aren't actuated Nash patients the stage one to three fibrosis.
This was a randomized and open label study of Dior nitrate Nash patients and it was conducted in the United States.
You are lightweight was dosed orally for 28 consecutive days at 50 milligrams or 150 milligrams once a day or 300 milligrams twice a day and followed it up for an additional 28 days.
Total 65 patients completed the state and there were at least 20 patients could dose group.
Key endpoints, including safety and pharmacokinetics clinical chemistry, and Biomarkers as well as liver fat content and liver stiffness by imaging. This includes MRI pdfs and fiber scale.
You are nitrate treatment in this trial resulted in a global reduction from baseline of liver enzymes liver fat and stiffness as measured by imaging answer with it.
Many of these reductions were statistically significant.
A statistically significant 24% reduction of plasma triglycerides.
Let's see in 60 patients who had baseline triglyceride level above 200 milligrams per deciliter.
43% of the patients in this trial had at least a 10% reduction I live in fact as measured by M. R. I Pdfs.
In this group a patient liver fat liver stiffness liver enzymes answer, but that's where statistically significantly reduced.
For additional detail on the results in this study I encourage you to review our press release.
You are nitrate was well tolerated at all three dosage evaluate there were no serious adverse events reported during the study pharmacokinetic parameters after repeat dosing were comparable to those after a single goes from a prior study, indicating no accumulation that repeat dosing.
Also drug exposure was dose dependent.
We believe having multiple important parameters all moving at a positive direction are particularly impressive when you consider the patients were only dose for one month.
Also the fact that a number of the improvements were statistically significant is impressive given that there were only a little over 20 patients per dose group.
Additional results, including biomarker data are still be analyzed.
They are delayed because of the pandemic.
We hope is that these additional results and the data analyses at an upcoming scientific meeting.
These results achieved over a short course of treatment together with the continued safe profile Dior lightweight are promising indicated a view our nitrates potential in Nash.
Next to the positive program.
However, as our investigational post operative paid to the depot that uses our patented favorite technology and its the right. You can look would be pivoted to provide up to three days of pain relief after surgery.
That's the anesthetic and analgesic drug products Advisory Committee meeting in January this year, we have continued to interact with the FDA. They continued to review the problem or indeed.
If approved we plan to license was much with partner for commercialization in the United States.
We expect this deal would include a meaningful upfront license fee and royalties based on product set.
In summary.
The company continues to function well in this new environment.
We are finalizing the protocol for the phase to be do you aren't actuate trial and severe h. patients and are on track to start in the second half of this year.
Based on the result from the Phase two way trial, we're optimistic that if we're able to demonstrate a robust survival benefit in this trial it makes support and da filing.
We are adding clinical sites into video on actuate phase two trial in cold in 19 patients with acute liver or kidney injury and the trial is poised to start dosing.
We reported topline results from our phase one be trial do you aren't actuate and Nash patients.
Liver enzymes, they were fat and stuff as well as plasma lip. It's all moving in the right direction or particularly impressive when you consider the patients were only dose for one month.
The fact that a number of these improvements were statistically significant is impressive.
Given that there were only 21 to 23 patients per dose group.
When you combine these impressive results with the safety profile do you want actuate, we believe it has a chance to be an important player in the Nash space.
We look forward to additional results from the Nash trial being presented at an upcoming scientific meeting.
During the quarter, we continue to answer the FDA information requests regarding the Posner India.
We look forward to potential approval of plasma and a potential commercial partnership.
But most of all we look forward to how do you aren't actuate, maybe able to help patients with devastating conditions like alcoholic hepatitis and Coca banking.
With that we'd now like to take any questions you might have.
Thank you.
At this time will be conducting a question and answer session. If you'd like to ask a question. Please press star one on your telephone keypad a confirmation Tony will indicate your line is in the question Q. You May proceed start to if you'd like to remove your question from the Q.
Participants using speaker equipment, and maybe necessary to pick up your handset before pressing the star Keith one moment, please while we poll for questions.
[noise]. Your first question comes from line of L. eat Merle with Cantor Fitzgerald. Please proceed with your question.
[laughter] so much for taking my question and congrats on another.
Okay.
Just in terms of the coal bed Bath <unk> body can do you think about you know that the timing in terms of potential data read out and maybe the cadence of enrollment that you've seen so far if you open up the initial I just curious your expectations around money cut on the data from this study and then my second question in terms of.
Oh gosh I'm now that you'd have more time to digest that yeah. I'm curious your latest thoughts you know next potential stops and now you know what potential that he could look like you know when you plan to speak with yeah, Yeah, I about a potential sort of power to gnashing up you know any combination approaches.
You think you know me protect ourselves given the biology. Thanks.
Sure.
So to start with the cobot, what we're doing right now is we're actually setting up the site. We originally set up sites in the and the areas of the country. We're looking at work New York, New Jersey, Detroit, Chicago, where there was the most.
Active going on as far as infection rates and hospitalization and as we all know those areas, except for maybe Chicago had quite a down although now there you're picking up again and so in the interim we have also now been setting up sites across a places that I mentioned during the talking that would be southern Cal.
I would point your taxes and other areas around the country.
Where are the infections are.
[laughter] much much higher.
What we've been doing.
Said is it getting these sites set up as far as we are poised to what we havent dosed the first patient yet, but we're right on the cost of being able to do that as far as how long it will take to enroll I think that's really going to depend on on a number of things, but primarily really on.
How the infection rates and go within the area is what we're set up because it takes a number of months from when you identify a site and.
And are able to get drug there and get going just from a logistics standpoint.
So we're staying active and poised to in the New York, New Jersey, and some of these other areas, where most likely will pick up in the fall out and maybe even sooner and we'll be able to be there to help some of those patients. So it's difficult to predict right now a.
You know what we would have data my expectation is that.
It will depend for sure on the infection rates, but I know, it's something where we'll be getting data over the next year and I can't give anymore from line other than that Unfortunately, we see that compliance with mass market isn't that great in the United States and sell these infections will continue.
Even you know if there's an hopefully there will be vaccine coming out maybe to turn at year they'll still we a lot of people who don't.
Well I could be vaccinated walk imply I'll be taking while the come in that kind of thing. So I think it's actually going after a while and I will have an opportunity to help some of the most severely ill patients and that's what we're looking for being able to do and together I read out for other I see you indications beyond alcoholic hepatitis.
For the or nitrate.
As far as Nash and in next steps what we've shown so far is putting marketable if you consider but it's a 28 day study and we only had about 20 patients the group.
To have statistically significant measurements out of that that's smaller number for that small Todd.
I think is pretty impressive and once again the drug is shown to have this very a wide safety margin.
We're not seeing a lot with regard to the anything as far aside if that's your concern. So if we've got a drug that with a wide safety margin and apparently and then and it's got such a breath of activity, it's difficult to say what drugs it might be used with could probably be used with a lot of dry.
Especially don't fit that cause issues that may be perfect circulating look it should go up that kind of thing, but I think it remains to be seen it may end up being a good monitor it because we saw it not only listen if it's down but we also saw circulating lipids down we saw the LDL down the h. deals down and triglycerides down each month.
Pretty impressive.
She goes information and I think also to see fiber scan improvement the statistic fiber scana proven at four weeks is yes, it's really nice to see.
Our next step would be though to advance it in interface to that would be the next the next step for the Nash program, but I see the I see you used the nitrate an alcoholic hepatitis and Kobe and potentially other ice you uses as being a much faster to market then Nash doesn't mean that Nash isn't a great opportunity.
Or possibly other chronic users for nitrate great opportunities, but it's just the time to market and the impact of those that he can be we can rival Nash and come up so.
Hi, Thanks, so much.
Sure.
Your next question comes from line of American Anchormen timing.
With B. Riley. Please proceed with your question.
Good afternoon, Dean Thanks for taking my question in Canada, I agree I myoglobin across almost all stages of development and.
Pete.
Maybe we can start that boots in either any color you could prove right on the nature of these in masonry glass. If any are you starting to feel like Oh labeling.
No. It's still I don't want to give any color beyond that you know they still continue there's still the kind of questions. One would ask is you're viewing and then D.A.
So I don't want I don't want a shade anyone left or right on this thing I think it's better just too you know just to be patient and see what comes out of it. We have you know like we think that this drug can can be a benefits hopefully in the post operative space. It should it be approved.
It certainly has shown in clinical trials that does it you know reasonably good job at being able to control pain and it gives narcotic use so I'm, hoping it has an opportunity to get out there and help patients I don't know, Mike you want to add anything to that.
Yeah, I think it's it's just you.
No we don't want to it we don't want to try to handicap, what we think is happening you know.
It's hard enough to predict and we'll see we'll see what happens when they make a decision but.
Yeah, we just want people to understand that there's an active review happening that they're asking questions and we're answering.
Beyond that we don't really want to provide color on what the nature of the questions are.
Great.
Thanks for taking that and then under <unk> on the covert 19 hospitalized patients but sure.
Yes, they do selection there one could be make you additive to the I think the its study had a pretty good attack that 90 make those Ah. So if you could comment on that and also you know what sort of backbone therapies.
Given this is a very different sort of study relative to you know the the anti inflammatory drags out the aren't they like what.
Well what are some of the background therapy is your including or excluding.
Well pretty much including most drugs I don't think where we have an issue with pretty much anything, but all of which he speaks to the dosing to concomitant therapy, so wait cheap.
Sure.
Well I think that that they'll sort of coal. The 19. We did this allows that to 150 milligram dose so number one and sell we get the past the in the age 1200, 50 milligram well tolerated in the most of yeah.
And those that we should be a alcoholic hepatitis patients. So that that's a safety and PK data, how we have already generated thought that that pick a lot. Those and then now come down to that coal that the patients. They oh, yeah right from the alcoholic hepatitis.
Patients all sold another they most to lay but that enjoy most till they focused on that number and then for this drug it's a short enough. It's a mostly concentrated in another so but for coal that 19 patients not only they have never enjoy maybe some more.
By them up most most importantly, they have simply I loved Angel eight.
Now also they help on top all bad because I was a population of the pacing well also set out in those patients having that can enjoy all that.
So in other words, you want to have the drug Toby Oh targeting to balance today kidneys and in other she told I love that so that's why that those calculation, we walked out based on the Oh, Yeah PK data, we have done in the past that though.
Our truck distribution information, we need to camp hundred 50 milligram doses. So that's how we selected that out.
In the cold and I'd be patient so they won't be treated differently as the alcoholic hepatitis patients naturally.
What about concomitant bed twitchy any quick any statement Oh, no. We I know a basically all the odd.
Oh come that's considered standard of care to be used for this group of patients. So which is currently now we know it includes the run desalvio as well like that somebody that's up.
Oh that that's a map is on what we had the six milligram doses boss and saw a sick. They thought that all 10 days and then Oh of course, there's somebody else. So we don't have any concern about that easy I issue.
Yeah.
That's great. So you'll be able to see you know they did at a compound is going against standard of care, but on I'd do it on top of that great and then.
Oh on unmatched pretty quickly obviously at a very short timeframe.
I mean the.
Biomarkers across the board move they consistently just curious about your card Sun as you know a nice studies are shortening in terms of.
How do you know you're looking at biopsy. So any any color I know you're talking about next dancing and you're still working through that.
Oh, how are you thinking about the land go Oh. This next study that you might have.
Well she wanted you know.
So that one.
Yeah. So we haven't rally gave out Oh. He tells about the out next study. So however, no. We have the reason we did that's one study is because we at a time when we initiated the study where it doesn't have long term top study by now we didn't really have a lot.
Tom talk study available so in other ways, we cut the potential they conduct that that length of the study and the last week, we would like to low cat, but done that study will rollout that yes, I'm often asked study.
When the time comments by them at this moment without discussing with Alcatel Elds away I try and Tony laid out and a more importantly, as Jim mentioned only away still are waiting for some of the important about market data. So once we have all the data Oh.
I will hand, we all know cat all the data and then Oh gosh, what I'll tell ALS and that's on the next phase study for Nash and determined that those determined that a dose regimen.
That you all agent after treatment, then Oh, we will communicate that by that.
That's right into rates you. Thank you Jim.
Okay.
Your next question comes from line of a friend Swab Brisbois with Laidlaw. Please proceed with your question.
Hi, sorry, not.
I'm worried that that up in high but [laughter].
[laughter].
The so so what I just wanted to ask here was in terms of the PK rationale to go with 150 and I understand what you were saying about the cobot patients are quite different but when you look at the PK was there a rationale there that made sense that the 60 and 90 or you know I know a small small numbers, but might have had better.
Survival and 100% survival in D.A.H. versus the 150, any any Ah things that we've learned sense.
No I think I'll, let Richie follow up it first of all all the once if he's been ideas into Thirtys. All survived it so they all did well and their meld scores were all down one day 28, so they all not only survived but they all improved over the month, which is very important as when she was describing when you. When you look at what's going on in covert.
As they age where they should get multi organ damage for sure and some patients died number the patients that sets it but in cobot do they all that multi organ damage and when we go sideways systemically.
In the cobot patients we wanted to be assured that we could be the long and the kidney and enough drug to be effective and we based upon everything from what are the concentrations in vitro all the way after the alomar alternative humans. So wait she maybe.
Sure Oh, so Florida for the alcoholic hepatitis patient a skin sad first of all all follow 19 patients to by the time to eight days, including those tool without the old School high end 0.45, which is still a dumb response cut off.
Number four.
Automobile score. So however, you do see ER and the high dose will be you do have told patients higher then decide the sponsor for cell.
Now one thing I would like let's say based on what we Oh understand the off that drug.
It's not the expected.
And also based on the Ah that's among many others to us on the market that they have multiple targets targets and the also they have Bob that wave broad.
Periodic ink that I, it's not uncommon as well so I think that's well alcoholic hepatitis Oh, we actually Oh I.
Based on our understand they may be a someday, we will disclose what they stuck throughout the acts like a that we actually it's not the expected to for US maybe they'll know what else that's worked well and on top of that alcoholic hepatitis patient they have very severe hepatic inflammation and the coldest they test.
Yes.
Well, that's a many of them have been cirrhosis, because helped a longtime consumption of alcohol, but the for the cold that patients.
Dan Ludlum may not be.
I've enjoyed oh, so us the alcoholic hepatitis and that's kind of extreme situation, but then the most important it's we want to target a lot in this way I also want to pocket that kidneys. So that's how based on when we put the older. They tell we.
Hi, I'm together, we've not had a alcoholic hepatitis trial, we look at the out the M.T.K. drop distribution PK and that's how we will you did terming that out for the alcoholic hepatitis.
Oh, absolutely well that at a lower dose level at least some based on all dayparts. So far we have hundred percent response rate and I'd like to know what else is.
And then by then political but we want to.
You'll stuff safe by then maybe that most.
Yes that kept that was.
That.
I think that's a really [laughter], that's an important point just to just appetite for a second because I think 14 of those patients workshop you see it I'm talking about H. patients now. So there are limits were not functioning normally by any stretch and so this drug is excrete it through the bile. So there are 150 in in a patient like that it's very.
From 100, Vicky and you're even severely ill critical most really on critically ill call. The patient. So you get different exposure is based on the condition of the body.
Okay, No that's great and I apologize in terms of the survival I mean, I meant to higher score [laughter] patient, but so and in terms of the age patients you mentioned about 117000 hospitalizations, how often do you hear of age patients that are hospital.
Survive and her hospitalized again is this a recurring thing where the same patient my you know be back in the hospital the same here.
It does depend there are some patients where that's the case and mortality is quite high though and that populations and by the time you get to the point, where you're being hospitalized you know that historic rate would tell us that that I'll talk appetite as patients have a 28 day mortality of.
About 25%, 26% right so quarter those patients so.
And a number of those patients are.
Yes.
Really come to grips with with the issue, they're dealing with by virtue of being so ill. So if they don't passed away there are lot of them.
Change, what's going on but some won't and and go through it but that's the actual numbers where repeated I don't know that we had that from the data might do you.
The call the specifics of that.
Yeah, that's actually something that we're looking.
Looking at various data sources right now to try to try to get our arms around what the what could repeat rate is.
It's not super high within a year, but we're gonna get we're gonna take those numbers out but from a from an opportunity perspective, you know if somebody.
Once the hospital and got treated and then came back nine months later and got treated again.
You know that would just be as.
Separate incidence of the same acute condition and there would you know we don't see the reason why they wouldn't be treated again.
Yeah, no northern see no. We also believe the drug to be affected second time around well.
Okay, Great and then just lastly, if I can they get one more Andy I was wondering if that meant that reimbursement I think are in terms of insurance of these patients that I you know I understand they can be from all walks of life or not just wondering is it 89% you mentioned there on the insurance.
Yes was 89% hospitalized patients that have insurance yep.
Okay, great. Thank you very much that's it for me sure. Thank you.
Your next question comes from one of the Ed Arce with H.C. Wainwright. Please proceed with your question.
Hey, Jim in my Thanks for taking my questions and congrats on.
The progress through a several programs here with nine to wait.
Some of my questions have been answered I I did want to go back to.
To age a.
A couple of questions. Firstly, you know you you made the point at least a couple times that you really do thinks that this study.
If you know substantively substantively is positive Uh huh [laughter] could.
Could Brett present, a sole pivotal study ER and databases for in India, I remember I think on the first quarter call. It while that was as well the case then HM.
Your.
Youre feeling about it was a bit more conservative a bit more cautious on that possibility and I'm just wondering.
Or if there's been any sort of a change from your perspective has there been any discussions.
Or.
Or input that has led you to feel incrementally more positive about the possibility.
Well, we you know we certainly don't have any new data, but we do you know gathers much information as the cat all different sources.
And at the end of the date it comes down to its especially in the first quarter I think we're still thinking that possibility of maybe doing biomarkers versus survival and now we're definitely going to do survival as our primary endpoint. So if one has oh you know they've shown.
They want to show Uh Huh.
Substantial improvement in survival over.
Over placebo in an environment, where there is no therapy. Today. There is no approved therapy, then that puts us in a position more inline with what one might see.
These oncology indications and others and yeah, we did speak to the number of program gets to collagen early really 2010 on up were just a single trial has been not to be able to achieve approval. So it's it's more learning more and then focusing on on survival as the primary endpoint.
Right right. Okay. That's helpful and then staying with age I'm just wondering if there.
Yes, you think about the the enrollment.
I realize you know your youre.
You are looking to dose here in the coming months, but.
As you look towards the sites that you're speaking to and thinking about the issues.
<unk>, particularly in the I see you in the hospitals a in this particular cope with 19 environment.
Do you do you anticipate any any sort of other issues around enrollment other than just getting through covert 19.
And I I think yeah.
Sorry.
So.
When.
One one night you think.
You might be in a position to report data.
I.
I think if we look in enrollment in in a pandemic this circumstance actually unfortunately it it.
Probably will enhance our enrollment for this trial and the reason being because people are sheltering in place as much as they can.
And they are board in there around the house more more stressed that kind of thing alcohol consumption is up in the United States and whenever you know work, we're talking to many many centers around the United States.
As we are preparing.
Setting up sites, where the covert trial and number of them are liver kidney specialists and when we talk to them. They you know this deliver specialists in particular will come on say, Okay. I wish you had that age trial I've got three patients getting right now and I'm seeing X number of weak. So they are I I believe I don't have any further evidence that we've done a market research, but I've been talking to people.
In a in observing that you know I call Consumptions up it appears as if there's more h. right now and there was a year ago.
And and if that is indeed, the case then that puts us into this should be able to help those patients because if you've got age you've got you can't stay home. This is not an electric circumstance that you know you stay home good chance you might guy so you've got to get to the hospital and B C and hopefully we'll be able to.
Either what that drug can help some of these patients.
Okay.
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And then or just one other.
One other question related to.
The the termination of the deal with Gilliat recently I don't know if you are care to expound on a anything there with your former partner in terms of you know what that see what led to that decision.
But also kind of related to that.
Yeah.
If you could.
Perhaps share with us how things are continuing or with other potential partners around the sabre technology. Thanks.
Sure No. We continue we always had this baseline of work that we do with our legacy technologies and and we had that would you know we and we continue to have those kind of the problem feasibility deals that we have a number if you've already deal about going right now and they really had relationship was one of those then it made progress, but they're always the programs that we signed up.
To help people that are always extremely difficult because there's so many drug delivery.
Technologies out there today that are available on a more generic form that people. They run through all those first with their internal chemist before they ever come see us because were were expensive, but we have you know something that can possibly deliver and and so that as you know we received 25 million upfront from Gilliat any other Ken.
Okay and quickly in a milestone for $35 million.
There was an opportunity we believe our chemist lead to be able to to be successful at least opportunity for that going forward the topic gilliat elected.
Not to do that and that is their choices and that's always the drug delivery businesses. The.
The difficult because of that you're always at the wind up whatever partner you half and that's why I'm. So pleased that no direct.
That's no longer our major part of the business. They talk about it consider it really legacy there there was a component of it.
As the at the base a level Oh, what we are who we are either positive or gets approved them with a partner that will be wonderful. Yeah. You know, we're very happy to have the degree or a you know revenue stream coming in and other feasibility thing going on but.
The real reason to be interested in direct is what what nitrate affords and to be able to help patients with this wonderful molecule and others in the family.
Thanks, so much.
Sure.
Ladies and gentlemen, if you'd like to ask the question. Please press star one on your telephone keypad as a reminder, you'd like to ask a question. Please press star one on your telephone keypad now one moment. Please all we pull for questions.
Your next question comes from lineup Len, Yeah see with stock Doc Partners. Please proceed with your question.
But Jim I think a limited data suggest that the 30 day rehospitalization rate for age is about 23%.
And some patients depending on their coverage.
Nine two way to successful could be very significant.
From a reimbursement level 'cause reimbursements, depending on the coverage one has to be different if your we ask lives for the same disease state within 30 days, it's longer than three days, so could be a significant positive for d. white nine to eight.
Thank you for West we call it speaks well to it speaks well to getting the patient out quicker, which we are able to as well because that would start to clock on as well so exactly [laughter] picking back up again I was wondering in the past obviously nash's been.
Focus before he became important potentially and obviously the covert 19 epidemic.
Can you say when you would expect to start the next clinical what here. The next clinical study for Scott and if you're in fact committed to it or is this big emphasize because of a tremendous opportunity in the other indications you know we do have a wonderful opportunity with A.H. and with covert both and you know you should probably be effect.
And helping these patients it could be to market and the than the agent. So I think the potential and that'll go then for AK I infer pneumonia sepsis and a whole bunch of other I see you utility.
You know disease states that don't really have much to help them with today. So we really are very excited and looking forward to being able to see what we'd be able to do with actuate in that study well that being said, though we are not.
You know going to put Nash on the shelf, we're still looking at Nash and we're evaluating its way. She said, we're working with our thought leaders.
It's you know given everything it's probably not best right in the middle of raging pandemic to say, we're going to start you know this.
Study for Nash right now I think it's it's probably it's difficult because one doesn't know where this fires gonna burn I think of it as a fire and of course is jumping around and you know so you might be fine in this in this canyon today, but tomorrow it might be raging and so you could go on a go to this girl setting I'm going to get from aspirations down there.
And they may be.
Are there I see is maybe for covered patients in too much. So I I think that you know what we're doing homework, we're doing our work which is the right thing to do right now why we're working on the on the I see you use it and then we'll bring forward Nash at the right time, but it's not on the shelf by any stretch okay. It on the face to be a study is adding 24 months study.
Okay.
Well each patient is going to be all the dose for.
You know one or two doses and then we'll follow them up we have a bit.
As you can follow them up for a certain amount of time, we haven't even given that out yet, but we go so let me start to trial, but it it it'll just be a number of months that will follow up each patient. So you know when you talk about the duration the duration. It will be then how fast can we enroll.
Patience and centers are set up center, we're setting up that is already now open the U.S. and in Europe, it'll be a multinational trial.
As I said, there's more I called being consumed here I I don't have the numbers in Europe, I guess, if not down there I can't imagine, it's probably you know gone up as well. So we'll we'll give more information on the duration expected duration study once we're into it and getting sites up and running and see how long it's gone.
Great. Thanks very much.
Sure.
Ladies and gentlemen, we have reached the end of the question and answer session and I would like to turn the call back to Mr., Jim Brown for closing remarks.
Okay with that well I just want to Ah we want to thank you all for your time today and hope that you and your family Stacy and look forward to stick with any view in the future. If you have any call questions. Please feel free to give us color Laura Thanks, a lot take care.
This concludes today's conference you may disconnect your lines at this time. Thank you for your participation.
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